A 75-YR-OLD MALE WITH HISTORY OF GUILLAIN BARRE SYNDROME IN THE INTENSIVE CARE UNIT. PT HAD BEEN IN THE HOSP SINCE 9/95. PT FOUND AT APPROX 10:48 AM ON 11/14/95 TO BE DISCONNECTED FROM HIS VENTILATOR FOR AN UNKNOWN PERIOD OF TIME. WHEN FOUND HE HAD CYANOSIS AROUND THE LIPS AND A RATE OF 54. PUPILS WERE APPROX 4 MM AND NOT FIXED AND DILATED. PT WAS RESUSCITATED AND EVENTUALLY DIAGNOSED WITH BRAIN DEATH. ON 11/22/95 HE WAS DISCONNECTED FROM HIS VENTILATOR BY FAMILY DECISION AND EXPIRED AT APPROX 9:00 AM. THE FOLLOWING IS A SUMMARY OF EVENTS OF 11/14/95 RECONSTRUCTED AFTER STAFF INTERVIEWS: PT WAS IN BED POSITIONED IN THE "HIGH FOWLER'S" POSITION. APPARENTLY, THE BED ALARMS APPROX EVERY TEN MINUTES WHEN IN THIS POSITION. STAFF INTERVIEWED STATE THAT THIS BED ALARM IS EXTREMELY LOUD AND ANNOYING. AT SOME POINT DURING A BUSY SITUATION IN THE ICU, THE PT INVOLVED IN THIS INCIDENT BECAME DISCONNECTED FROM THE VENTILATOR. ESTIMATES HAVE RANGED FROM 1 TO 7 MINUTES BASED ON THE LENGTH OF TIME THE BED WAS ALARMING AND FROM CHART TIMES. THE RN WENT TO THE ROOM INVOLVED AND SHUT OFF THE BED ALARM. UPON DOING THIS, SHE THEN IMMEDIATELY HEARD THE VENTILATOR ALARM GOING OFF. ACCORDING TO HER, THE BED ALARM OBSCURED THE VENTILATOR ALARM. SHE IMMEDIATELY NOTED THE PT'S CONDITION AND AFTER MANUAL VENTILATIONS AND ATROPINE FAILED TO REVIVE HIM, A CODE WAS CALLED. A RHYTHM WAS OBTAINED AT APPROX 11:01 AM. ONE MAY NEVER KNOW HOW THE DISCONNECT OCCURRED AS THE PT WAS IMMOBILE DUE TO HIS MEDICAL CONDITION. HOWEVER, ACCORDING TO STAFF THERE HAD BEEN TWO PRIOR DISCONNECTS WITH THE SAME EQUIPMENT AND APPARENTLY THERE WAS ANOTHER DISCONNECT AFTER THIS EVENT. THE ADAPTOR, WHILE IT CONNECTS WELL WHEN PUT TOGETHER WITH TWO HANDS, SEEMS TO POP OFF WHEN USED ON A ENDOTRACHEAL TUBE WHERE CARE MUST BE TAKEN NOT TO APPLY TOO MUCH PRESSURE. THE QUESTION OF WHETHER OR NOT A BAND DEVICE OF SOME SORT SHOULD HAVE BEEN USED TO KEEP THE ADAPTOR AND TUBE TOGETHER HAS BEEN BROUGHT UP. THE BED ALARM, WHILE SERVING ITS PURPOSE, WAS FELT TO BE EXCESSIVELY LOUD AND MASKED THE VENTILATOR ALARM. IT WAS SUBSEQUENTLY FOUND THAT THE NOISE LEVEL IS ADJUSTABLE AND IT WAS ADJUSTED DOWN.
ELECTROSURGICAL UNIT CURRENT DISCHARGED AT HANDLE/BLADE ATTACHMENT SITE DURING A TONSILLECTOMY RESULTING IN BILATERAL MOUTH BURNS. EQUIPMENT AS FOLLOWS WAS TAKEN OUT OF USE AT THIS POINT. NURSE NOTED ARCHING AT TIP OF HANDSWITCH, POSSIBLY CLOSE TO YELLOW BUTTON. DEVICE WAS USED ON A 63-YR-OLD OPERATIVE SITE. (NOSE) O2 WAS IN PT MOUTH. O2 DC'ED. PT NASAL HAIRS SINGED, NO UNTOWARD EFFECTS.
PHYSICIAN SHOCKED BY ELECTROSURGICAL PENCIL.
HYPERGLYCEMIA: A CUSTOMER WHO USES REGULAR INSULIN IN HER PUMP EXPERIENCED ELEVATED BLOOD GLUCOSE READINGS 2 DAYS IN A ROW. (AS HIGH AS 440 MG/DL). SHE CHANGED THE TUBING AND THE VIAL OF INSULIN, BUT HER BLOOD GLUCOSE LEVEL DID NOT NORMALIZE. SHE STATED THAT THE VIALS OF INSULIN IN QUESTION APPEARED NORMAL AND SHE HAS HAD NO CHANGES IN DIET, EXERCISE, STRESS LEVEL OR HEALTH STATUS. IN A FOLLOW-UP PHONE CALL RECEIVED FROM THE PT, SHE STATED THAT SHE HAD SINCE DISCOVERED THAT THE "DRIVE ARMS" ON HER PUMP WERE NOT WORKING AND NOW FEELS THERE WAS NOTHING WRONG WITH THE INSULIN.
E FOR M CORP. CARDIOLOGY PRODUCTS DIV. 9221 QUIVIRA RD, OVERLAND PARK, KS 66215-3905. IT IS E FOR M CORP'S OPINION THAT THE COMPLAINT IS NOT BASED UPON KNOWN FACTS OR FACTUAL COMPARISON OF THE PRODUCT'S ARCHITECTURE, DESIGN, OR INTENDED USE. E FOR M CORP CAN ONLY ASSUME THAT THE MISLEADING LETTING IN QUESTION WAS FROM MEDIKA, ADDRESSED TO HELLIGE, AND WAS A PRECAUTIONARY ACTION TAKEN BY MEDIKA TO ESTABLISH THE 510(K) STATUS OF THE PRODUCTS AND TO INSURE THAT ONLY THOSE PRODUCTS WITH THE PROPER CLEARANCE WERE OFFERED FOR SALE.
WHEN THE STAPLER WAS USED TO STAPLE PANCREAS OFF, THERE WAS AN APPARENT MISFIRE. STAPLES DID NOT EJECT, PT LACERATED AND RESULTED IN A 600CC EBL AND ADDED APPROX 1 HR TO THE CASE. THE STAPLER IS THE TYPE THAT NEEDS TO BE FIRED TWICE TO DISCHARGE THE STAPLE. THE FIRST TIME THE STAPLER IS USED TO SET THE TISSUE AND THE SECOND TIME IS USED TO DISCHARGE THE STAPLE. A RESIDENT WAS THE ONE WHO FIRED THE STAPLES. IT IS UNKNOWN IF THE RESIDENT FIRED THE STAPLER ONCE OR TWICE. A CO REP AND A REP FROM THE HOSP EXAMINED THE STAPLER. THE CARTRIDGE WAS NOT WITH THE STAPLER. THE STAPLER LOOKED GOOD AND WAS PLACED BACK INTO USE. THE HOSP HAS NOT HAD A SIMILAR COMPLAINT AND THE STAPLER IS WORKING CORRECTLY. THE CARTRIDGE AND ANVIL WERE DISCARDED. PACKAGE INSERT CONTRAINDICATES USE OF THE STAPLER ON "LIVER, SPLEEN AND SIMILAR TISSUE AS COMPRESSING THESE TISSUES WOULD BE DESTRUCTIVE." "SIMILAR TISSUE" WOULD INCLUDE PANCREAS. "TO FIRE THE STAPLES, SQUEEZE THE HANDLE COMPLETELY A SECOND TIME." CO BELIEVES THESE INSTRUCTIONS WERE NOT FOLLOWED. (LABEL)
PT, A BLACK MALE, 1.56 BSA WAS IN OR FOR A ROSS PROCEDURE. A HEART LUNG MACHINE, FIVE ROLLER PUMP BASE INCLUDING CARDIOPELGIA MODULE WAS IN USE. "ELECTRICAL" SYSTEM WAS FULLY CHARGED, NO ALARMS INDICATED, AND HEART LUNG MACHINE HAD BEEN OPERATED DIRECTLY FROM IT DURING SETUP FOR SEVERAL MINUTES WITHOUT INCIDENT. ALL SYSTEMS ON DEVICES PRESENT WERE ACTIVATED, AND IN PT READY CONDITION. ARTERIAL PUMP HAD RECIRCULATED THIS PRIME AT 1.5 L/MIN THROUGH A-V LOOP FOR APPROX 15 MINUTES WITH BUBBLE DETECTION MODULE ALARMS ACTIVATED, PRIOR TO STOPPING ARTERIAL PUMP, AND SEPARATION OF A-V LOOP INTO DISCRETE ARTERIAL AND VENOUS LINES. NO SYSTEM ALARMS OCCURRED. PT WAS CANNULATED WITHOUT INCIDENT, ORDER WAS GIVEN TO INITIATE CARDIOPULMONARY BYPASS. THERE WAS A SYSTEM ACTIVATION, ALARMING "AIR", AND ARTERIAL PUMP AUTOMATICALLY SHUT OFF. ARTERIAL PUMP WAS THEN PLACED IN NEUTRAL. A TUBING CLAMP WAS PLACED ON ARTERIAL LINE DISTAL TO ARTERIAL LINE FILTER, AND DOCUMENTATION WAS OBTAINED THAT NO AIR WAS PRESENT IN SYSTEM FROM ARTERIAL FILTER TO ARTERIAL CANNULA. BUBBLE DETECTION TRANSDUCER WAS REMOVED FROM ARTERIAL LINE, ULTRASONIC GEL REAPPLIED, AND TRANSDUCER REPLACED ON ARTERIAL LINE (DISTAL TO FILTER, PROXIMAL TO PT) IN A SLIGHTLY DIFFERENT POSITION. BUBBLE DETECTION MODULE ALARMS WERE THEN RESET, AND IMMEDIATE PREBYPASS CHECK LIST REPEATED. SYSTEM AGAIN ALARMED "AIR." BUBBLE DETECTION TRANSDUCER WAS REMOVED FROM BACKUP HEART LUNG MACHINE. EXISTING BUBBLE DETECTION TRANSDUCER WAS REMOVED AND REPLACED WITH SECOND BUBBLE DETECTION TRANSDUCER. DEVICE CONTINUED TO ALARM "AIR." ENTIRE BUBBLE DETECTION/LEVEL SENSOR MODULE FROM BACKUP HEART LUNG MACHINE, WAS OBTAINED AND EXISTING MODULE WAS CHANGED OUT. FOLLOWING ACTIVATION DEVICE ALARMED "AIR." ARTERIAL AND VENOUS LINES WERE THEN DISCONNECTED AT TABLE FROM PT CANNULAE, AND AN A-V LOOP REESTABLISHED BY SURGEON. BUBBLE DETECTION ALARMS WERE THEN RESET AND ARTERIAL PUMP WAS OPERATED WITH BUBBLE DETECTION MODULE TURNED ON. IT DID NOT ALARM. PT CANNULAE WERE THEN REATTACHED TO ARTERIAL AND VENOUS LINES AND BYPASS WAS INITIATED WITHOUT INCIDENT. PT WAS SLOW COOLED TO 32 DEGREES CENTIGRADE. APPROX 10 MINS INTO BYPASS CARDIOPLEGIA LINE WAS FLUSHED. HALF WAY THROUGH ARRESTING DOSE OF CARDIOPLEGIA, THE 4 CHANNEL TEMP MODULE AUDIBLE ALARMS ACTIVATED. ALL FOUR TEMP DISPLAYS FLASHED "0" THEN "-". SIMULTANEOUSLY, THERE WAS A SYSTEM ACTIVATION OF ARTERIAL PUMP, AND ROLLER BEGAN TO HESITATE AND JERK. PERFUSIONIST DEACTIVATED EXT ON PUMP, AND ROLLER RESUMED NORMAL RPMS. 4 CHANNEL TEMP MODULE, AUDIBLE ALARMS WERE PLACED IN OVERRIDE POSITION, AND THEY SILENCED, BUT CONTINUED TO INTERMITTENTLY FLASH "0" THEN "-" FOR NEXT FEW MINUTES. FOLLOWING COMPLETION OF CARDIOPLEGIA ADMINISTRATION, EXT ON ARTERIAL PUMP WAS REACTIVATED, AND ROLLER CONTINUED TO RUN SMOOTHLY FOR DURATION OF CASE. THERE WERE NO FURTHER INCIDENTS. PT'S OXYGEN CONSUMPTION, AND ACID/BASE STATUS WERE EXCELLENT THROUGHOUT PROCEDURE, AND HE WAS SUCCESSFULLY WEANED FROM BYPASS.
AT 9:30 AM, 1 1/2 HRS INTO A HEMODIALYSIS SESSION, PT COMPLAINED OF NAUSEA. HER BLOOD PRESSURE WAS 113/66 AND HER PULSE WAS 90. AT 9:40 AM, THE PT BRIEFLY BECAME UNRESPONSIVE (3-5 SECS). SHE WAS GIVEN 200 ML NSS. HER BLOOD PRESSURE WAS 127/68. SHE COMPLAINED OF CHEST PAIN AND SHORTNESS OF BREATH. AT 10:15 AM, SHE CONTINUED TO HAVE CHEST PAINS, DEVELOPED APNEA, AND BECAME UNRESPONSIVE. PT HAD CARDIAC ARREST. DIALYSIS WAS STOPPED AND A CODE WAS CALLED. THE PT WAS ACCIDENTALLY GIVEN CALCIUM FREE DIALYSATE. FIVE AMPULES OF CALCIUM GLUCONATE WERE ADMINISTERED AND THE SYMPTOMS RESOLVED. LOOK ALIKE LABELING CONTRIBUTED TO THE ERROR. THE STOCK NUMBER, WHICH IS SUPERIMPOSED ON THE LABEL OVER THE ELECTROLYTE CONTENTS, IS DIFFICULT TO SEE CLEARLY. TECHNICIANS WERE USING THE STOCK NUMBERS TO PULL THE PRODUCTS. (LABEL.)
AT 9:30 AM, 1 1/2 HRS INTO A HEMODIALYSIS SESSION, PT COMPLAINED OF NAUSEA. HER BLOOD PRESSURE WAS 113/66 AND HER PULSE WAS 90. AT 9:40 AM, THE PT BRIEFLY BECAME UNRESPONSIVE (3-5 SECS). SHE WAS GIVEN 200 ML NSS. HER BLOOD PRESSURE WAS 127/68. SHE COMPLAINED OF CHEST PAIN AND SHORTNESS OF BREATH. AT 10:15 AM, SHE CONTINUED TO HAVE CHEST PAINS, DEVELOPED APNEA, AND BECAME UNRESPONSIVE. PT HAD CARDIAC ARREST. DIALYSIS WAS STOPPED AND A CODE WAS CALLED. THE PT WAS ACCIDENTALLY GIVEN CALCIUM FREE DIALYSATE. FIVE AMPULS OF CALCIUM GLUCONATE WERE ADMINISTERED AND THE SYMPTOMS RESOLVED. LOOK ALIKE LABELING CONTRIBUTED TO THE ERROR. THE STOCK NUMBER, WHICH IS SUPERIMPOSED ON THE LABEL OVER THE ELECTROLYTE CONTENTS, IS DIFFICULT TO SEE CLEARLY. TECHNICIANS WERE USING THE STOCK NUMBERS TO PULL THE PRODUCTS. (LABEL.)
SEVERAL YEARS AGO PT HAD A LAMINECTOMY FOR A RUPTURED DISC. SEVERAL MONTHS LATER DISC RUPTURED AGAIN. PT UNDERWENT A FUSION PROCEDURE WITH PEDICLE SCREWS. PT HAD THE PEDICLE SCREWS REMOVED 1 YEAR LATER DUE TO THE SCREWS CAUSING A HEMATOMA.
COMPLAINANT HAD A TOTAL OF 8 PEDICLE SCREWS IMPLANTED TO STABILIZE SPINAL COLUMN AFTER TRAUMATIC INJURY TO HER BACK FOLLOWING A SEVERE CAR ACCIDENT IN 2/94. NOW 2 OF THE SCREWS NEED TO BE REMOVED BECAUSE THEY HAVE BROKEN.
THE PACKAGING AND THE CARTON ARE LABELED THAT THE EXTENSION SET INCLUDES A CLAMP. THE RPTR HAS A FULL CASE OF 50 AND A HALF CASE THAT DOES NOT HAVE CLAMPS.
A MEMBER OF THE FIRE AND RESCUE SQUAD WAS RESPONDING TO AN EMERGENCY (ASTHMATIC EPISODE). THE RESCUE PERSONNEL HAD AN ALUMINUM TYPE CANNISTER WITH 15 LPM HIGH FLOW REGULATOR TO DELIVER OXYGEN THERAPY. APPARENTLY, AFTER TURNING THE OXYGEN TO 6 LITERS PER MINUTE, IN ONE MINUTE THE TANK "EXPLODED." THE RESCUE PERSON SUSTAINED 2ND DEGREE BURNS TO THE HAND AND FACE (AND WAS LATER FLOWN TO A BURN CENTER). THE ASTHMATIC RECEIVED "SINGED HAIR", WAS TAKEN TO THE HOSP AND LATER RELEASED. MFR WAS CONTACTED BY THE FIRE DEPT AND IS COMING TO THE SITE.
MEDEX, INC. 3637 LACON RD, HILLIARD, OH 43026-1289. THEIR INVESTIGATION REPEATEDLY SHOWED THAT THIS ISSUE RESULTED WHEN THE CLINICIAN INSERTED TEH NEEDLE INTO THE BURRETTE INJECTION PORT AT A SEVERE ANGLE AND SHEARED OFF A SECTION OF THE PLASTIC MATERIAL WITH THE NEEDLE. THIS WAS DISCUSSED WITH THE HOSP STAFF. THE PRODUCT MGR VISITED THE HOSP AND DISCUSSED SEVERAL OPTIONS TO ADDRESS THIS ISSUE IN ADDITION TO RETAINING THE STAFF. THE MATERIAL USED TO MOLD THIS COMPONENT IS STANDARD FOR THIS TYPE OF APPLICATION AND IS NOT CONSIDERED TO BE A CONTRIBUTING FACTOR. THIS PRODUCT IS DISTRIBUTED TO MANY OTHER HOSPS WITHOUT SIMILAR INCIDENT.
THE SYRINGE PUMP WAS BEING USED TO INFUSE MEDICATION IN A 4-YR-OLD PT UNDERGOING A PROCEDURE IN MRI. THE PUMP WAS APPROX 5-6 FEET FROM THE MRI MAGNET WHEN THE FORCE OF THE MAGNETIC FIELD PULLED THE PUMP FROM THE HANDS OF A CRNA. THE PUMP FLEW THROUGH THE AIR AND ATTACHED TO THE MAGNET. THE PUMP DID NOT STRIKE THE CHILD DURING FLIGHT, HOWEVER, THE POTENTIAL FOR SERIOUS INJURY WAS GREAT.
HMP/NEOSTAR MED TECHNOLOGIES. THE ENCLOSED REPORT (#1008014) INDICATES A DEVICE WHICH WAS DISTRIBUTED BY HORIZON MED PRODUCTS, INC. BUT WAS NOT MFG BY HORIZON MED PRODUCTS, INC. THE DEVICE IS A COOK PACEMAKER CORP. CAT NUMBER IPS-9010, SN 011125. HORZON MED PRODUCTS, INC. HAS NO RECORD OF RECEIVING THIS COMPLAINT OR THE DEVICE IN QUESTION FROM TWIN LAKES REG MED CTR. HOWEVER, A REVIEW OF OUR RECORDS DOES INDICATE THAT THE DEVICE WAS DISTRIBUTED BY HMP. PER THE REQUIREMENTS OF 21 CFR SECTION 803, WE ARE FILING THIS DISTRIBUTOR MDR REPORT AND HAVE CONTACTED THE MFR. OUR INTERNAL COMPLAINT REF IS H0139. IF YOU HAVE ANY QUESTIONS OR DESIRE ADD'L INFO, PLEASE DO NOT HESITATE TO CONTACT ME DIRECTLY AT 610-337-1277.
NO FORWARD FLOW REGISTERED BY THE BIOCONSOLE. NO RESISTANCE IN TUBING TO DENOTE FLOW. PT PLACED ON HANDCRANK BYPASS UNTIL BIOCONSOLE CHANGED. ALL EQUIPMENT CHECKED AND FUNCTIONING. ABLE TO SIMULATE PROBLEM THAT WAS CREATED ON 10/25/95 AFTER SECOND INCIDENT. TUBING AND BAG DISCARDED. RPTR THINKS PROBLEM WAS ELECTRICAL.
PT WAS SCHEDULED FOR A LAPAROSCOPIC TUBAL BANDING. AT LEAST SIX PAIRS OF TUBAL OCCLUSION BANDS BROKE DURING THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO A MINILAPAROTOMY FOR PURPOSES OF TUBAL LIGATION. THE SALES REPRESENTATIVE WAS NOTIFIED.
THE PRODUCT WAS USED BY CRNA IN STARTING AN A-LINE IN THE RIGHT WRIST. WIRE WOULD NOT WITHDRAW AFTER CATHETER IN POSITION. CATHETER AND WIRE REMOVED INTACT. THE J-WIRE WAS BENT IN TWO PLACES. SECOND RADIAL CATHETER KIT USED FOR CANNULATION. ANESTHESIA REQUESTED PRODUCT BE REPORTED TO MFR FOR DEFECT.
PT CAME BACK TO FACILITY WITH BROKEN (RUPTURED) BALLOON RESERVOIR, WHICH WAS FILLED WITH 5-FU FOR 5 DAYS. MOST OF THE CHEMO SOLUTION WAS IN A PLASTIC INFUSOR. THERE WAS SOME CHEMO SPILL. NURSE CLEANED THE SPILL. PT DID NOT RECEIVE 5-FU FOR ABOUT FIVE HOURS.
WHEN MOVING LITTER SCALE TOWARDS PT'S BED, THE LITTER ARM FELL OFF (BROKE). THE ARM STRUCK THE PT, NO TISSUE DAMAGE WAS NOTED. THE WELD BROKE ON THE LITTER SUPPORT ARM.
DURING A CODE, DEFIBRILLATOR WOULD NOT CHARGE. ANOTHER DEFIBRILLATOR WAS AVAILABLE AND WAS USED. FAILURE OF DEFIBRILLATOR REPRODUCEABLE. RETURNED TO MFR. NO PT INJURY.
EMT'S WERE RESPONDING TO PT IN CARDIAC ARREST SITUATION. PT WENT INTO V-FIB AND WAS SHOCKED AT 200 WATTS SECONDS. MONITOR FAILED AFTER D-FIB AND WOULD NOT FUNCTION. BENCH TEST REVEALED THAT PADDLES WERE SHOWING ARTIFACT AND WOULD INTERMITTENTLY PASS EKG WITH LOTS OF ARTIFACT. EKG LEADS WERE DOING THE SAME. EKG WAS SHOWING A DOTTED FLATLINE WITH NO EKG ON SCREEN OR RECORDER VIA LEADS OR PADDLES.
IMPLANT PLACED RIGHT CHEST WALL. LEAK NOTED JUST PRIOR TO CLOSURE OF WOUND. IMPLANT EXPLANTED AND REPLACED WITH SECOND IMPLANT.
PT STATES THAT HE HAD NORMAL VISION UNTIL ELECTROENCEPHALOGRAM WAS PERFORMED AND HE WAS INSTRUCTED TO MAINTAIN GAZE ON A FLASHING LIGHT. SINCE THAT TIME HE HAS COMPLAINED OF LOSS OF CENTRAL VISION WITH CENTRAL SCOTOMA IN EACH EYE. VISION 20/60 RIGHT EYE AND 20/200 LEFT EYE. EXCELLENT COOPERATION ON COMPUTERIZED VISUAL FIELD WITH NO FIXATION LOSSES OR NO FALSE POSITIVE ERRORS WITH EITHER EYE. NORMAL VISUAL FIELDS. MACULAE HAVE RED HUE.
AN 8-MONTH PREGNANT FEMALE PRESENTED WITH WHEEZING, RASH AND EDEMA AFTER PELVIC EXAM FROM AN OUTSIDE PHYSICIAN, WEARING LATEX GLOVES. TREATED WITH "STAT" DIPHENHYDRAMINE IM.
PER RPTR, APPARENTLY, THE DONOR BLOOD AND TRANSPORT SOLUTION TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA, BUT AFTER EXPOSURE TO THE ANTIBIOTIC COCKTAIL, THE COCKTAIL AND CO-PROCESSED TISSUE CULTURED NEGATIVE, SO THE PROCESSOR FELT THAT THE TISSUE WAS STERILE AND RELEASABLE. THERE WERE TWO RECIPIENTS WHO RECEIVED VALVES FROM THIS DONOR. BOTH, RPTR BELIEVES WERE CHILDREN. ONE APPARENTLY PRESENTED WITH HEART TROUBLE AND PNEUMONIA (ORGANISM UNKNOWN). THIS PT DEVELOPED AN INFECTION WITH THE PSEUDOMONAS ORGANISM WITHIN A COUPLE DAYS OF THE 12/29/92 IMPLANT. (BLOOD AND WOUND CULTURED POSITIVE). SURGICAL DEBRIDEMENT WAS DONE, THEN A BLEEDER DEVELOPED SECONDARY TO THE DEBRIDEMENT, SO THE PT UNDERWENT AN OPERATION TO CLOSE THE BLEEDER. AFTER A LONG COURSE, AND AFTER TRANSFER TO ANOTHER HOSP, THE PT WAS DISCHARGED IN 2/93, AND RETURNED A WEEK LATER WITH THE SAME INFECTION. THE INFECTION APPARENTLY FINALLY RESOLVED AND THE PT IS ALIVE; 2/95 WAS THE LAST KNOWN ASSESSMENT. (SEE 1008027.) DATE IMPLANTED 12/29/92.
PER RPTR, APPARENTLY, THE DONOR BLOOD AND TRANSPORT SOLUTION TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA, BUT AFTER EXPOSURE TO THE ANTIBIOTIC COCKTAIL, THE COCKTAIL AND CO-PROCESSED TISSUE CULTURED NEGATIVE, SO THE PROCESSOR FELT THAT THE TISSUE WAS STERILE AND RELEASABLE. THERE WERE TWO RECIPIENTS WHO RECEIVED VALVES FROM THIS DONOR. BOTH, RPTR BELIEVES WERE CHILDREN. ONE CHILD DIED WITHIN 1 DAY WITH CONDUIT ONLY. DETAILS OF THIS OPERATION WERE SKETCHY, BECAUSE THE CHILD RECEIVED ONLY THE CONDUIT PORTION OF THE IMPLANT, AND NOT THE VALVE, SO THE HOSP DID NOT WANT TO DIVULGE ADDITIONAL INFORMATION. SINCE THE DEATH OCCURRED SO SOON AFTER IMPLANT, IT IS UNLIKELY THAT PSEUDOMONAS COULD HAVE BEEN THE CAUSE, BUT IT IS NOT KNOWN. (SEE 1008026.)
8/89 RPTR HAD BREAST TISSUE REMOVED AND BREAST IMPLANTS INSERTED. 10/92 IMPLANTS WERE REMOVED BECAUSE OF NUMEROUS PROBLEMS. SHE HAS CONTINUING HEALTH PROBLEMS.
RPTR HAD TWO SALINE-FILLED MAMMARY IMPLANTS INSERTED 11/8/95 REPLACING ANOTHER MFR'S SILICONE IMPLANTS. SHE CONTINUES TO SUFFER FROM RHEUMATOID ARTHRITIS. WHETHER OR NOT IT IS RELATED TO THE IMPLANTS IS STILL UNKNOWN.
OMRON HEALTHCARE, INC.300 LAKEVIEW PKWY, VERNON HILLS, IL 60061. THE COMPLAINT WAS CLOSED IN OUR COMPLAINT SYSTEM BECAUSE THE INVESTIGATION SHOWED NO DEFECTS. NO MDR WAS ISSUED BECAUSE THERE WAS NO INDICATION THAT SERIOUS HARM OR ONJURY WOULD COME TO THE USER.
RPTR C/O SILICONE GEL WEEPING. NO GEL LEFT IN SILICONE ENVELOPES. THERE IS SILICONE THROUGHOUT HER BODY WITH EVEN SMALL PARTICLES OF SOME MATERIAL EXUDING THROUGH THE SKIN. SHE HAS NEUROLOGICAL INVOLVEMENT AS PER MRI, LUNG INVOLVEMENT AS PER PFT'S,A SUBCUTANEOUS NODULARITY DOWN BOTH LATERAL THIGHS (SMALL AND HARD). SHE HAS BEEN DIAGNOSED WITH CONNECTIVE TISSUE DISEASE, LUPUS-LIKE SYSTEMIC SCLEROSIS?, RAYNAUD'S PHENOMENON, SJOGREN-LIKE SYNDROME AND MYASTHENIA GRAVIS.
ON THREE SEPARATE OCCASIONS, WHEN THE LIGHT COVERS WERE OPENED ON THE STERILE FIELD AND ABOUT TO BE PLACED ON THE LIGHT HANDLE, A TEAR WAS NOTICED IN ONE OF THE GLOVES. THIS OCCURRED THREE TIMES OVER THE COURSE OF TWO WEEKS.
VENTILATOR FAILED TO TRIGGER, EVEN WHEN MANUAL BREATH BUTTON WAS PRESSED. ALARM DIDN'T SOUND EITHER.
A 1CC TUBERCULIN SYRINGE WAS FOUND SEALED IN THE PACKAGE WITH NO SHEATH ON THE NEEDLE.
ON 10/27/95, THE DISTRICT OFFICER VISITED THE RETAILER AND SPOKE TO THE PHARMACIST, WHO WAS FAMILIAR WITH THE CASE. HE HAD 2/10 SYRINGE BAGS. DISTRICT OFFICER OBSERVED TEN SYRINGES WITH A GLOB OF MATERIAL IN THE SYRINGES. UPON PUSHING THE PLUNGER AND DRAWING IT BACK THE GLOB SPREAD ALONG THE WALLS OF THE SYRINGES. THE PHARMACIST SAID THE SUBSTANCE WAS SILICONE LUBRICANT. HE WAS UNFAMILIAR WITH SIMILAR CASES. HE SAID HE THOUGHT THE COMPLAINANT OVER-REACTED. THE DISTRICT OFFICER THEN VISITED THE COMPLAINANT. SHE HAD TWO OPENED AND THREE UNOPENED BAGS OF SYRINGES. THE OFFICER EXAMINED THE SYRINGES IN ALL BAGS AND FOUND NONE WITH AN EXCESS OF SILICONE. SHE SAID SHE RETURNED AN UNKNOWN AMOUNT TO THE MFR, ALONG WITH HER INSULIN ON 10/12/95. THIS IS THE FIRST TIME SHE ENCOUNTERED THIS RPOBLEM. (*)
RODS HOLDING THE LOWER 5 VERTEBRAE ARE HELD IN PLACE BY 4 SCREWS OR BOLTS THAT WERE NOT INTENDED FOR THAT USE. THE SCREWS ARE TOO LARGE AND RUB AGAINST MUSCLES INCAPACITATING THE PT.
THE PT WAS ON AN IV PCA WITH MSO4 AT 2MG/HR AND 1MG FOR 15 MINUTES. THE PUMP WAS SET FOR 1MG/ML CONCENTRATION AND A 5MG/ML CONCENTRATION SYRINGE WAS PLACED IN PUMP WITHOUT REPROGRAMMING THE CONCENTRATION SETTING. (THE PUMP AUTOMATICALLY DEFAULTS TO A 1MG/ML SETTING). THE PATIENT RECEIVED 10MG/HR FOR APPROXIMATELY 8 HOURS. UPON RETURN FROM X-RAY THE PATIENT WAS CYANOTIC AND UNAROUSABLE. 2 HOURS PRIOR TO THIS THE PATIENT WAS AWAKE AND FOLLOWING COMMANDS. THE PATIENT WAS INTUBATED, BP AND PULSE WERE MAINTAINED THROUGHOUT THE INCIDENT. THE PATIENT WAS TRANSFERRED TO SICU. THE PATIENT WAS AROUSABLE AFTER BEING GIVEN NARCAN AND ABLE TO FOLLOW COMMANDS. CXR- RIGHT LUNG ASPIRATION NO EKG CHANGES. INITIAL ABG 6.90/120/79/23, PULSE OX 85%. PT HAD ONE MONTH STAY IN ICU, UNABLE TO WEAN FROM VENTILATOR. PT HAD RIGHT LUNG ASPIRATION LEADING TO PROLONGED VENTILATION ASSIST. DISCOVERED 8 HRS AFTER OCCURRENCE WHEN PT WAS UNAROUSABLE. THE PT WAS ABLE TO BE WEANED FROM THE VENTILATOR IN 7/95, AND DID RECOVER.
FEMORAL HEAD FAILED TO LOCK IN PLACE UPON APPLICATION TO FEMORAL STEM.
WHILE VENTILATOR WAS IN USE, PT BEGAN LOSING VOLUME OF APPROXIMATELY 600-800 ML PER BREATH. THERAPIST BEGAN TROUBLESHOOTING PATIENT CIRCUIT AND VENTILATOR. THE VENTILATOR WAS CHANGED, BUT PATIENT BEGAN LOSING VOLUME AGAIN. UPON ATTEMPTING TO SUCTION PATIENT, THE THERAPIST NOTED THAT THE SUCTION CONTROL ON THE DEVICE WOULD NOT SPRING BACK TO NORMAL POSITION. THE SUCTION SYSTEM WAS REPLACED AND THE VOLUME LOSS PROBLEM ENDED.
THREE PATIENTS ARE INVOLVED. THE DISCS FAILED TO DIAGNOSE STREP INFECTIONS. THE PATIENTS CONTINUED TO HAVE HIGH FEVERS. TESTS WERE CONDUCTED WITH ANOTHER PRODUCT AND ALL THREE PATIENTS WERE GROUP A STREP POSITIVE. THE RPTR THINKS THE PRODUCT IS DEFECTIVE.
CATHETER INSERTED LEFT UPPER ARM ON 12/13/95. ON 12/17/95 PATIENT COMPLAINED OF SORENESS AND DISCOMFORT IN LEFT UPPER ARM DISTAL TO INSERTION SITE. PATIENT CLAIMS TO HAVE HAD SOME PAIN EVER SINCE IV STARTED. PT HAD AMPHOTERICIN B THERAPY ON 12-13. LEFT UPPER ARM CIRCUMFERENCE 24.5 AND RIGHT UPPER ARM CIRCUMFERENCE 22.5 CM AT TIME OF EVENT. PT HAD EDEMA DISTAL TO INSERTION SITE. ACTUAL SITE WITHOUT ERYTHEMA OR EDEMA. CATHETER INTACT AND PATENT UPON REMOVAL ON 12/17/95. SYMPTOMS RESOLVED IN APPROXIMATELY 3 DAYS WITH WARM COMPRESSES. CATHETER DISCARDED BY HCP.
DURING AN ARTHROSCOPIC PROCEDURE, SURGEON NOTICED THE DISTAL RIGHT THIGH WAS HARD. HE IMMEDIATELY STOPPED THE ARTHROSCOPY PUMP WHICH WAS INFUSING LACTATED RINGERS. IT WAS DETERMINED THAT A FLUID EXTRAVASATION INTO THE RIGHT THIGH HAD OCCURRED. SURGEON SUGGESTED THAT PUMP WAS MALFUNCTIONING. THE PRESSURES HAD BEEN REGULATED BY THE SURGEON WITH THE HAND CONTROL DURING THE PROCEDURE. THE SAME PUMP HAD BEEN USED ON THE PREVIOUS CASE WITHOUT INCIDENT. THE PUMP WAS REMOVED FROM SVC. THE CASE WAS CANCELLED; SURGERY COULD NOT BE PERFORMED AFTER THE EXTRAVASATION OF FLUID INTO THE THIGH. MFR WAS NOTIFIED. THEY REQUESTED THE PUMP BE RETURNED TO THEM WITH THE DISPOSABLES (TUBINGS) USED IN THE CASE AND THE CANNULAS.
PROVIDERS COMPLAINED OF SPECULUMS BEING SHORT AND THEY WERE DIFFICULT TO LOCK PROPERLY DURING INSERTION. THEY WERE ALSO VERY DIFFICULT TO UNLOCK AFTER A PAP PROCEDURE, INCREASING PT PAIN.
THE PT HAD INSERTION OF PE TUBES IN BOTH EARS AS A CHILD. NO DATES ARE AVAILABLE FOR THE ORIGINAL PROCEDURE. THE PT HAS A LONG HISTORY OF CHRONIC OTOMASTOIDITIS. THE PT WAS ADMITTED FOR TYMPANOMASTOIDECTOMY ON 11/2/95. DURING SURGERY A PE TUBE WAS FOUND IMBEDDED IN DENSE ADHESIONS IN THE AREA OF THE EPITYMPANUM.
PT HAD IMPLANT SURGICALLY REMOVED FROM RIGHT LITTLE FINGER. PT DID NOT RECEIVE A NEW IMPLANT.
ON 8/27/87 PT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT FOR SEVERE OSTEOARTHRITIS. IN 10/94 PT FELL AND STRUCK A CONCRETE STEP, INJURING HER RIGHT KNEE. SHE DEVELOPED PAIN AND THE KNEE WAS EVALUATED BY THE ORTHOPEDIC PHYSICIAN. ON EXAM PT PRESENTED WITH DEFINITE LOOSENING OF THE METAL BACK PATELLAR COMPONENT WITH FRACTURE OF THE FIXATION STEMS INVOLVING THE PATELLAR COMPONENT AS NOTED ON X-RAY. PT WAS ADMITTED TO THE HOSP AND TAKEN TO SURGERY ON 2/7/95 FOR A RIGHT TOTAL KNEE REVISION. DURING SURGERY THERE WAS FOUND DEFINITE EVIDENCE OF METALLOSIS SUBSEQUENT TO THE FRACTURED TITANIUM PATELLAR COMPONENT. A SYNOVECTOMY WAS PERFORMED WITH ATTENTION DIRECTED AT REMOVING ALL METALLIC FRAGMENTS. ON INSPECTION THERE WAS A DEFINITE WEARING OF THE POLYETHYLENE METAL BASE PLATE AS NOTED WITH A FRACTURE OF BOTH FIXATION STEMS. A REVISION OF THE PATELLAR COMPONENT, REMOVING THE METAL BACK COMPONENT IN EXCHANGE WITH ALL POLYETHYLENE COMPONENT, AND EXCHANGE OF THE TIBIAL POLYETHYLENE ARTICULAR SURFACE WAS CARRIED OUT.
DURING DIAGNOSTIC LAPAROSCOPY THE INSULATING COATING OF THE BIPOLAR COAGULATING CURVED SCISSORS FELL OFF. SURGEON WAS UNABLE TO RETRIEVE CERAMIC PIECE. MFR HAS NOTIFIED CO THAT THE COMPONENT THAT SEPARATED IS ZIRCONIA CERAMIC WHICH HAS BEEN TESTED TO BIOCOMPATIBILITY STANDARDS. IT WAS ALSO NOTED THAT THIS PRODUCT COMPLAINT HAS OCCURRED BEFORE WITH A PRODUCT RECALL IN 5/94, HOWEVER, THE LOT NUMBER RECALLED WERE NOT THE SAME.
DURING D&C/OPERATIVE LAPAROSCOPIC WITH LEFT SALPINGO-OOPHORECTOMY THE STAPLES USED DURING PROCEDURE CAME OFF AND THE PT BEGAN TO BLEED. A LAPAROTOMY WAS THEN PERFORMED TO CONTROL THE BLEEDING OF THE VESSELS (THIS WAS DONE AFTER AN ATTEMPT TO CONTROL THE BLEEDING WITH BIPOLAR FORCEPS.
PT RECEIVING BLOOD TRANSFUSION VIA SINGLE LUMEN CATHETER IN RIGHT NECK. AT 2130, PT HEAD WAS REPOSITIONED. A LARGE HEMATOMA WAS NOTED ON THE RIGHT SIDE, CHEEK AND NECK MEASURING APPROXIMATELY 3.5 CM X 3.0 CM. X-RAY WITH CONTRAST REVEALED A HOLE IN THE CATHETER. CATHETER WAS REMOVED.
REMOVAL OF BREAST IMPLANTS. RIGHT AND LEFT IMPLANT RUPTURED.
FREE FLOW DUE TO BROKEN ACCTUATOR. PT RECEIVED 1800CC FLUID INSTEAD OF INTENDED 900CC. 11/28/95-CE IDENTIFIED THAT ONE OF THE TWO ACCTUATOR TIPS BROKEN. THIRD EVENT AT THIS INSTITUTION. NO PT RESIDUAL HARM IDENTIFIED. NOTE: ALL TRIPLE CHANNEL PUMPS ARE BEING PULLED AS OF 12/1/95. MFR AWARE.
PT IN OR ON 11/1/95 FOR A LAPAROSCOPIC CHOLECYSTECTOMY, LYSIS OF ADHESIONS AND MARCAINE NERVEBLOCK. AS THE CLIP APPLIER FROM THE LAPCHOLE KIT WAS BEING INSERTED THROUGH THE TROCAR PART OF THE INNER SEAL (REDUCER) WAS SEPARATED FROM THE SLUNE AND ENTERED THE PT'S ABDOMINAL CAVITY. THE SEPARATED PORTION WAS REMOVED VIA THE LAPAROSCOPE BY THE SURGEON. CO REP WAS NOTIFIED. NO INJURY TO PT.
ENTERAL FEEDING TUBE INSERTED WITHOUT DIFFICULTY. X-RAY DONE. REPORT SHOWED THAT TUBE WAS IN THE LUNG. NURSE WAS CONTACTED TO REMOVE THE FEEDING TUBE IMMEDIATELY. THE TUBE WAS REMOVED WITHOUT DIFFICULTY. THE PT DEVELOPED RESPIRATORY DISTRESS. THE NURSE ATTEMPTED TO SUCTION AND BAG THE PATIENT. NURSE MET GREAT RESISTANCE WITH BAGGING. PT CONTINUED TO HAVE RESPIRATORY DISTRESS; HEART RATE DECREASED AND A CODE WAS CALLED. THE ER PHYSICIAN ASSESSED THE PT'S AIRWAY, REPLACED HER TRACHEOSTOMY TUBE, THEN FINALLY PLACED BILATERAL CHEST TUBES. CPR WAS DONE THROUGHOUT. PT EXPIRED. RPTR'S CHIEF CONCERN IS THE DESIGN OF THE FEEDING TUBE - ESPECIALLY THE FACT THAT THE MERCURY TIP IS THE SAME DIAMETER AS THE FEEDING TUBE WHICH MAY CONTRIBUTE TO GREATER RISK OF PENETRATING THE LUNG.
DEFIBRILLATOR SHUT OFF FOR APPROXIMATELY 30 SECONDS DURING A CODE BLUE RESPONSE. DIFFICULT TO RESTART.
PT BEING PREPPED FOR CARDIOVERSION USING MFR'S CARDIOVERTER. PT RECEIVED ACCIDENTAL DISCHARGE OF 200 JOULES PRIOR TO BEING ANESTHETIZED, DUE TO ACCIDENTAL ACTIVATION OF UNIT BY TECHNICIAN. DEVICE HAD BEEN INSPECTED FOR NORMAL PM CHARACTERISTICS IN 10/95, WITH NO OTHER PREVIOUS HISTORY OF REPAIRS. NO OTHER MEDICAL INTERVENTION NECESSARY AND PT RECOVERED.
ON 12/29/95 PT HAD GENERAL ANESTHESIA AND SURGICAL REMOVAL OF LEAKING LEFT IMPLANT. IMPLANT WAS PLACED 12/1/95. PHYSICIAN REPORTS APPROX 25CC MISSING FROM IMPLANT. REPLACEMENT REQUIRED FOR DESIRED COSMETIC EFFECT. (*)
FACILITY HAS BEEN USING THIS TUBING IN CONJUNCTION WITH PUMP FOR CONTINUOUS INFUSIONS OF 5-FU. THEY HAVE BEEN EXPERIENCING PROBLEMS WITH MEDICATION BEING LEFT IN THE RESERVOIR EVEN THOUGH THE PUMP SAYS ALL 100ML HAVE BEEN DELIVERED. AFTER RULING OUT PUMP FILLING ERRORS, THEY DECIDED TO SWITCH THEIR TUBING FROM THE MICROBORE TO THE MINIBORE TO SEE IF THE PROBLEM WAS IN THE TUBING. SINCE THE SWITCH TO A LARGER BORE TUBING, THEY HAVE HAD NO MORE PROBLEMS WITH DRUGS NOT BEING ADMINISTERED. PEOPLE SHOULD BE AWARE THAT THEY MAY NOT BE GETTING ACCURATE ADMINISTRATION AMOUNTS. THE RATE OF INFUSION WAS 0.6ML/HR. PERHAPS THE TUBING IS TOO CONFINING FOR SUCH A SLOW RATE BUT IF THAT IS THE CASE, THE MFR NEEDS TO MAKE PEOPLE AWARE OF THAT.
BLOOD NOTED IN THE INTRA AORTIC BALLOON PUMP DRIVE LINE. RESPIRATORY THERAPIST ATTEMPTED TO D/C REMOVE CATHETER PER PROTOCOL, MET EXCESSIVE RESISTANCE. DID NOT ATTEMPT FURTHER. POSSIBLE BALLOON CATHETER MALFUNCTION. BALLOON COULD NOT BE RETRIEVED.
FAILED PATELLAR COMPONENT WITH METAL ON ARTICULATION OF PATELLA COMPONENT TO THE DISTAL FERMORAL ARTICULATION.
A HAIR WAS FOUND IN THE DRIP CHAMBER OF THE TUBING.
THE RIGHT BREAST IMPLANT RUPTURED, AND REQUIRED REPLACEMENT, WHICH WAS DONE ON 3/8/95. SINCE THE INITIAL PLACEMENT OF THE IMPLANTS RPTR BEGAN TO HAVE NUMEROUS HEALTH PROBLEMS, INCLUDING, BUT NOT LIMITED TO: OSTEOARTHRITIS, FYBROMYALGIA, RAYNAUD'S PHENOMENON, SCLERODERMA, AND DEGENERATIVE DISC DISEASE.
THERE HAS BEEN ONLY ONE COMPLAINT OVER A 9 YEAR PERIOD OF THIS NATURE. THE LADY ORDERED AN EXTRA WIDE SHOWER COMMODE CHAIR FOR HER MOTHER. WHEN IT ARRIVED SHE DETERMINED IT WAS TOO LARGE FOR HER MOTHER AND SHE REORDERED THE MID SIZE SHOWER CHAIR/COMMODE AND RETURNED THE EXTRA WIDE ONE. SHE THEN CALLED BACK AND STATED HER MOTHER WAS "HANGING OVER" THE COMMODE SEAT. IN THE BACK OF THE CHAIR THERE IS A PLACE WHERE THE LID FITS, BUT ON A SHOWER CHAIR, THE LID IS LEFT OFF AND THIS PLACE FOR ATTACHING THE LID REALLY SITS BEHIND THE LINE OF THE BACK OF THE CHAIR. WHEN SHE CALLED IN, CO ASKED WHAT THE PROBLEM WAS AND SHE STATED HER MOTHER WAS LARGE AND THAT PART OF HER BUTTOCKS DROOPED OVER THE BACK OF THE CHAIR AND IT WAS UNCOMFORTABLE. CO SUGGESTED DELUXE FLAT SURFACE COMMODE SEAT. THIS SEAT IS LARGER AND SINCE SHE HAD A PROBLEM OF BEING TOO LARGE TO SIT ON AN ELONGATED SEAT WITHOUT DRAPING OVER THE SIDES, CO FELT THE SOFT SEAT WOULD BE MORE EFFICIENT. THIS WAS SENT OUT AT NO CHARGE TO THIS LADY. UNTIL CO RECEIVED THIS REPORT, CO THOUGHT SHE HAD BEEN TAKEN CARE OF AND WAS SATISFIED. ACTUALLY, SHE ORDERED THE WRONG CHAIR FOR HER MOTHER. NO NORMAL OR OVERSIZED PERSON WOULD HAVE ANY PROBLEM WITH STANDARD ELONGATED SEAT. IN 9 YEARS CO HAS NEVER HAD A SIMILAR COMPLAINT. EVEN WITH A LID, THIS LADY WOULD HAVE HAD PROBLEMS. WITH THE SEAT SHE HAS NOW, SHE WILL HAVE NO PROBLEM. THIS WAS NOT A REPORTABLE COMPLAINT, BECAUSE THE LADY ONLY STATED THAT THE PROTRUSIONS AT THE BACK OF THE CHAIR WERE UNCOMFORTABLE AND CO TOOK CARE OF THAT BY REPLACING THE STANDARD SEAT WITH A DELUXE SOFT SEAT WHICH SHOULD HAVE BEEN ORDERED IN THE FIRST PLACE.
COMPLAINANT'S WIFE WAS REPORTEDLY BURNED WHILE USING A SUNTANNING PRODUCT. THE INJURED PARTY WAS HOSPITALIZED ON 7/6/95. COMPLAINANT STATED THAT HIS WIFE VISITED THE SALON 3 TIMES AND USED A BOOTH BUT COMPLAINED OF NO TANNING EFFECTS. ON THE 4TH VISIT, SHE HAD RE-LAMPED THE BED AND SHE HAD NO BASE TAN DUE TO INEFFICIENT TANNING FROM PREVIOUS VISITS. INJURED PARTY IS A 30-YR-OLD FEMALE THAT NOW HAS REPORTED PERMANENT INJURIES.
AFTER USING THIS MATERIAL FOR THE FIRST TIME, RPTR OBSERVED THAT ITS NO DIFFERENT THAN THE MOST COMMON BONE REPLACEMENT MATERIAL ON THE MARKET. THE FIRM PROMOTED THIS PRODUCT AS SUPERIOR AND DIFFERENT THAN ANYTHING ELSE. RPTR FEELS THAT THE FIRM'S PROMOTION OF THIS PRODUCT IS MISLEADING. RPTR HAD NO OTHER COMPLAINTS ABOUT THE MATERIAL AND NO PT INCIDENTS TO REPORT. (*)
RPTR WITH RECURRENT FIBROCYSTIC DISEASE HAD ALL BREAST TISSUE REMOVED FOLLOWING A QUESTIONABLE BREAST BIOPSY. RECONSTRUCTION WAS DONE WITH SILICONE GEL IMPLANTS. IN 1982, CONTACT LENSES (MADE OF SILICONE) BEGAN TO DRY OUT, CAUSING CONSTANT IRRITATION. FREQUENT CARDIAC ARRYTHMIAS, EXTREME TENSION AND PAIN IN THE NECK AND SHOUDERS BEGAN. THE NECK AND SHOULDER PAIN WORSENED OVER THE NEXT TWO YEARS. RPTR BEGAN TO HAVE "PANIC ATTACKS" AND THE PAIN SPREAD INTO THE UPPER BACK ALONG SPINE AND BETWEEN SHOULDER BLADES. SHE NOTICED PROBLEMS WITH HER MEMORY. SHE DEVELOPED JOINT PAIN, MUSCLE SPASMS, NUMBNESS AND TINGLING OF UPPER AND LOWER EXTREMITIES AND VISUAL CHANGES. RPTR WAS DIAGNOSED WITH NERVE DAMAGE AND PERIPHERAL NEUROPATHY. LEFT IMPLANT WAS RUPTURED. RIGHT IMPLANT WAS LEAKING. ALSO REPORTS PAIN AND DISFIGUREMENT. SINCE REMOVAL OF IMPLANTS, SYMPTOMS HAVE DEVELOPED INCLUDING GASTROINTESTINAL PROBLEMS WITH ABDOMINAL BLOATING, DEGENERATIVE CHANGES OF SPINE, SILICONE IN LIVER. (*)
BAG HAS THE ZIP LOCK TYPE CLOSURE. THE BAGS ARE PACKAGED WITH THE SEALS LOCKED. WHEN OPENING THE BAG FOR TRANSPORTING, THE PLASTIC TEARS AWAY FROM THE SEAL ON THE SEAM LINE. THIS IS A RECURRING PROBLEM. MFR IS AWARE AND ALWAYS SENDS REPLACEMENTS, FAULTY BAGS KEEP SLIPPING THROUGH.
WHEN EMT ARRIVED AT SCENE, THEY FOUND THAT A WOMAN WAS BEING GIVEN CPR BY FAMILY MEMBERS (LENGTH OF TIME OF CPR UNKNOWN). AFTER EXAM EMT ATTACHED DEFIBRILLATOR PRE-GELLED PADS TO PT AND TURNED BATTERY OPERATED, PORTABLE DEFIBRILLATOR ON, SET TO ANALYZING MODE. LED SCREEN INDICATED PT WAS IN VENTRICULAR FIBRILLATION; DEVICE BEGAN TO CHARGE AND APPEARED TO BE PREPARING FOR SHOCK/DISCHARGE. WHEN SCREEN INDICATED DEVICE WAS READY FOR SHOCKING PT, UNIT JUST SHUT OFF. THERE WERE NO MESSAGES DISPLAYED ON EITHER RHYTHM DISPLAY SCREEN OR COMMAND DISPLAY SCREEN. VOICE COMMAND DID NOT WORK. EMT ATTEMPTED TO TURN UNIT BACK ON BY CLOSING AND REOPENING DEVICE LID BUT WAS UNABLE TO GET DEVICE TO TURN ON. SQUAD DID NOT HAVE A BACK UP UNIT. PT WAS NEVER DEFIBBED. FOLLOWING EVENT WHEN THE SQUAD RETURNED TO THE STATION, THE EMT CHECKED THE BATTERY WAS FOUND TO BE FULLY CHARGED AND DEVICE DELIVERED 260 JOULES WHEN USING A SIMULATOR. VOICE COMMAND DID NOT WORK DURING SIMULATION. DEVICE HAD BEEN SUCCESSFULLY USED FOR "MONITORING" HEART RHYTHMS APPROX 10 HRS BEFORE INCIDENT. DEVICE AND BATTERY HAD BEEN CHECKED AT BEGINNING OF SHIFT AND FOUND TO BE IN GOOD WORKING ORDER. DEVICE DID NOT INDICATE POOR CONTACT OR HIGH IMPEDANCE; AND STATION HAD NEVER HAD PROBLEMS WITH THIS PARTICULAR DEVICE.
BGC ENTERPRISES, INC. 4721 MURAT PLACE, SAN DIEGO, CA 92117. THE DEVICE REFERENCED ON THIS REPORT "AUDIOKINETRON" IS NOT OUR PRODUCT NOR IS IT MFG BY THIS CO.
VIOLATION OF CFR 102030G, REFUSAL TO SELL MATERIALS RELEVENT TO ABOVE CFR, SUBCHAPTER J. (*)
DURING SURGICAL PROCEDURE DEVICE DID NOT FUNCTION PROPERLY AND TORE FALLOPIAN TUBE.
PT DESIRES LARGER MAMMARY IMPLANTS FOR COSMETIC REASONS. RIGHT BREAST IMPLANT APPEARED TO HAVE ALREADY RUPTURED BEFORE REMOVAL. RIGHT BREAST CAPSULAR CONTRACTURE.
FEEDING TUBE INSERTION ATTEMPTED BY PHYSICIAN AND NURSES. X-RAY TAKEN AND SHOWED LEFT PNEUMOTHORAX. THE FEEDING TUBE WAS REMOVED AND A CHEST TUBE PLACED. THE SAME AFTERNOON A SECOND ATTEMPT WAS MADE AND X-RAY TAKEN. THE X-RAY SHOWED A RIGHT PNEUMOTHORAX. THE TUBE WAS REMOVED AND A CHEST TUBE WAS PLACED.
AIR MATTRESS WAS ON BED FOR PT. PT'S LEG GOT ON TOP OF LOWER SIDE OF MATTRESS, BETWEEN RAILS AND SIDE OF BED. PT MOTION OD SWINGING LEG CAUSED INJURY (SKIN TEAR TO RIGHT LEG).
AIR MATTRESS WAS ON BED FOR PT. PT'S LEG GOT ON TOP OF LOWER SIDE OF MATTRESS, BETWEEN RAILS AND SIDE OF BED. PT MOTION OF SWINGING LEG CAUSED INJURY (SKIN TEAR TO RIGHT LEG.)
STENT OF PROXIMAL RIGHT CORONARY ARTERY. PREDILATION WITH 3.0 CATHETER, SATISFACTORY LUMEN. PLACEMENT OF STENT WAS UNSUCCESSFUL DUE TO FAILURE OF THE BALLOON TO COMPLETELY INFLATE AND UPON REPREP AND REINFLATION AT THE RECOMMENDED INFLATION OF 8 ATMOSPHERES, THE BALLOON RUPTURED. IN AN ATTEMPT TO REMOVE THE BALLOON, THE STENT WAS DISLODGED WITH GUIDE WIRE TIP ENTRAPMENT AND ATTEMPTS AT RECROSSING THE DISLODGED STENT WERE NOT SUCCESSFUL, BUT THE VESSEL REMAINED PATENT.
AT 0500 PUMP WAS PROGRAMMED TO DELIVER 12CC/HR OF D10+CA GLUCONATE. AT 0530 34CC/HR HAD BEEN DELIVERED AS A BOLUS. FLUIDS STOPPED, METER VALUES = 239 (0600), 77 (0715). INFANT WAS DISCHARGED TO HOME ON 10/22/95.
A 82-YR-OLD MALE ADMITTED TO ER ON 11/5/95 COMPLAINING OF DIZZINESS AND EPIGASTRIC PAIN. SHORTLY AFTER ARRIVAL HE SUFFERED A SEIZURE, DEVELOPED RESPIRATORY DISTRESS REQUIRING INTUBATION. CO2 DETECTOR USED TO CHECK TUBE PLACEMENT. FIRST DEVICE DID NOT WORK. SECOND ONE REVEALED CORRECT PLACEMENT OF ET TUBE. WHILE BAGGING WITH AMBU BAG, VENTILATION BECAME DIFFICULT. PT SUSTAINED BILATERAL PNEUMOTHORACES, REQUIRING CHEST TUBES. PT VENTILATING WELL ON VENTILATOR, HOWEVER DIFFICULTY CONTINUED WITH AMBU BAG. IT WAS ULTIMATELY DISCOVERED THAT WHITE PLASTIC CAP HAD BECOME LODGED IN THE EXHALATION VALVE OF THE AMBU BAG. IT IS BELIEVED THAT THE CAP CAME FROM ONE OF THE DEVICES THE PT EXPIRED TWO DAYS LATER.
STENT WAS DEPLOYED INTO THE LEFT LIMB ABF GRAFT. THE BALLOON RUPTURED AND THE STENT WAS NOT COMPLETELY DEPLOYED. THE STENT WAS MOVED FROM ITS POSITION AND RETRIEVED WITH A CATHETER.
PT HAS RECURRENT SUPERFICIAL INFECTIONS, STIMULATOR SITE 2 DEGREE OBESITY. STIMULATOR WAS FUNCTIONING WELL.
A RECENT ROUTINE CHEST X-RAY SHOWED FRACTURED SUBCUTANEOUS PATCH LEAD WIRE FOR ICD SYSTEM. LEADS CAPPED AND LEFT IN PLACE - GENERATOR CHANGED.
PT SEEN IN DR'S OFFICE AND WAS FOUND TO HAVE NON-SENSING PACEMAKER, ORIGINALLY IMPLANTED 10/25/90.
LEFT FEMORAL INTRA AORTIC BALLOON RUPTURED. BALLOON TURNED OFF, BALLOON REMOVED AND REPLACED VIA OR TEAM.
PT HAD DIFFICULTY VOIDING DUE TO OCCLUSION OF PENILE IMPLANT RESERVOIR.
TUBING LEAKS AND SHEARING AT CONNECTIONS.
INFUSION PUMPS REQUIRING EXCEPTIONALLY HIGH NUMBER OF REPAIRS. INCIDENCE OF BATTERY FAILURE. C-CLAMP FAILURE. PROCESSOR BOARD FAILURE. CRACKED COMPONENTS.
PT WEARING STOCKINGS DEVELOPED DVT-SWELLING IN RIGHT ANKLE-FOOT.
DIALYSIS WAS INITIATED AT 10:45 AM WITH DIALYZER - PT HAD SUBCLAVIAN CATHETER WHICH RAN POORLY. IT RAN FOR ABOUT 20 MINUTES AND BLOOD RECIRCULATED. WHEN DIALYSIS WAS RESUMED, PT C/O SEVERE BACK PAIN. BLOOD RETURNED TO PT. PT STATES BACK PAIN STOPPED. DIALYSIS WAS RESUMED WITH ANOTHER DIALYZER WITH NO FURTHER COMPLAINTS. PT HAD BEEN ON DIALYZER SINCE 11/17/95. (*)
CATHETER PLACED 11/25. ON 11/30 PIN HOLE WAS NOTED WITH A LEAK AT THE PROXIMAL END OF THE CATHETER NEAR THE HUB. INSERTER HAD "DIFFICULTY THREADING PAST 30 CM AT FIRST, THEN THREADED TIGHTLY TO 43 CM WITH 17 CM EXPOSED" WHEN INSERTED. NO MENTION OF GUIDE WIRE BEING DIFFICULT TO REMOVE.
UNABLE TO PLACE .018 GUIDE WIRE THROUGH EITHER LUMEN OF THIS DEVICE DURING AN ATTEMPTED OVER-THE-WIRE CATHETER EXCHANGE BY INTERVENTIONAL RADIOLOGIST. HAD TO SWITCH TO ANOTHER PRODUCT.
CATHETER BROKE OFF 3-4MM PAST WHITE HUB DURING ORDINARY PT ACTIVITY. PLACED 11/27/95. REPAIRED WITH TEMPORARY KIT 12/8. REPLACED 12/12 PRIOR TO DISCHARGE ON HOME TPN.
ATRIAL LEAD IMPLANTED THEN EXPLANTED BECAUSE SCREW WOULD NOT EXTEND OR RETRACT.
ADD'L INFO PER CALL TO RPTR 1/3/95: THE LATEST IMPLANT IMPLANTED IN RPTR ON 12/4/95, IS ALSO LEAKING AND HAS BEEN TESTED SEVERAL TIMES SINCE IT WAS IMPLANTED IN RPTR. AS OF THIS DATE, THE LEAK CONTINUES. (ALSO SEE 1008050, 1008051).
FOLEY CATHETER REMOVED. TIP OF CATHETER MISSING (?RETAINED).
ABOUT 2/3 OF PLATELETS WERE INFUSED, THEN STOPPED INFUSING. NEW FILTER PUT ON AND REMAINDER OF TRANSFUSION ADMINISTERED.
PT HAD AMALGAM DENTAL FILLING NINE TIMES IN 9/95. PT HAD FIRST SEIZURE 10/26/95 AND 2ND SEIZURE ON 11/23/95. MRI OF BRAIN, EEG AND THE OTHER SEIZURE WORK-UP WERE NEGATIVE.
BECAUSE OF PAIN AND BURNING IN RIGHT ARM AND RIGHT BREAST (IMPLANT AREA) SURGERY WAS PERFORMED TO REMOVE THE RIGHT BREAST IMPLANT. PATHOLOGY REPORT DIAGNOSIS: "1. RIGHT BREAST CAPSULE, EXCISION: FIBROUS CONNECTIVE TISSUE CONSISTENT WITH IMPLANT. RELATED CAPSULE REFRACTILE FOREIGN MATERIAL CONSISTENT WITH SILICONE IF PRESENT AT THE SURFACE AND WITHIN HISTIOCYTES IN THE COLLAGEN LAYERS OF THE CAPSULE DYSTROPHIC CALCIFICATION IS PRESENT. PERIVASCULAR LYMPHOID AGGREGATES ARE PRESENT. 2. RIGHT BREAST CONTENTS, REMOVAL: SILICONE GEL FILLED IMPLANT, RUPTURED." (*)
ADD'L INFO PER CALL TO RPTR 1/3/95: THE LATEST IMPLANT IMPLANTED IN RPTR ON 12/4/95. IS ALSO LEAKING AND HAS BEEN TESTED SEVERAL TIMES SINCE IT WAS IMPLANTED IN RPTR. AS OF THIS DATE, THE LEAK CONTINUES. (ALSO SEE 1008045, 1008051).
ADD'L INFO PER CALL TO RPTR 1/3/95: THE LATEST IMPLANT IMPLANTED IN RPTR ON 12/4/95. IS ALSO LEAKING AND HAS BEEN TESTED SEVERAL TIMES SINCE IT WAS IMPLANTED IN RPTR. AS OF THIS DATE, THE LEAK CONTINUES. (ALSO SEE 1008050, 1008045).
PT RECEIVING PHOTOTHERAPY SUSTAINED SECOND DEGREE BURNS TO LOWER EXTREMITY DUE TO TIMER MALFUNCTION. PT SUSTAINED NO RESIDUAL EFFECTS AND HAD A FULL RECOVERY.
RPTR INITIALLY HAD BREAST IMPLANTS FOR COSMETIC REASONS. SHE HAS HAD TWO BREAST SURGERIES, BEGINNING WITH THE FIRST IMPLANT SURGERY. CALCIUM DEPOSITS OCCURRED BILATERALLY. RPTR CLAIMS TO HAVE BEEN DIAGNOSED WITH THE FOLLOWING AFTER IMPLANTATION: CHRONIC INFECTIONS, INTERSTITIAL CYSTITIS, LOW BLOOD PRESSURE, CARPAL TUNNEL SYNDROME, ANXIETY AND/OR DEPRESSION, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, FAINTING, PAIN AND/OR BURNING SENSATION, CHRONIC PAIN, CHRONIC DISCOLORATION (RED OR BLUE), HEAT OR COLD SENSITIVE, RAYNAUD'S DISEASE, CHRONIC DIARRHEA AND/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, VOMITING - WEIGHT LOSS OF 25 LBS, FREQUENT MIGRAINES / SEVERE HEADACHES. HYPERSENSITIVITY OR ALLERGIES TO: CHEMICALS, MOLDS, DUST OR POLLEN. CONNECTIVE TISSUE DISEASE, INFLAMMATION, SWELLING, PAIN / ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, MORNING STIFFNESS. MUSCLE PAIN AND BURNING, FIBROMYALGIA, NUMEROUS FRECKLES, OPEN SORES ON HANDS, CHRONIC INSOMNIA, CHRONIC FATIGUE SYNDROME, CLUMSINESS/DROP THINGS, PERIDONTAL DISEASE AND TOOTH LOSS (7 TEETH IN 1 YR).
RIGHT SIDE ENCAPSULATED SHORTLY AFTER IMPLANT.
LARGE VOLUME IV, 1000 ML LACTATED RINGERS, SPIKED WITH IV SET. READY TO BE ADMINISTERED TO PT. SURGICAL PERSONNEL NOTICED FOREIGN OBJECT. A STRINGY FILAMENT, APPROX 1/2" LONG IN THE DRIP CHAMBER.
BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMIES.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMIES.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
REPLACEMENT OF BILATERAL IMPLANTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE OF BREAST IMPLANTS - BILATERAL.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE OF BILATERAL BREAST IMPLANTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE OF BILATERAL BREAST IMPLANTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, NONE OR UNKNOWN, NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
WIRING HARNESS BECAME WORN AND INTERNAL WIRES BROKE, CAUSING SPARKS AND BURNING INSULATION. PTS WERE EVACUATED FROM ROOMS. CODE RED (FIRE) ALARMS WERE CALLED. THIS OCCURRED ON FOUR OCCASIONS. TWO IN JANUARY AND ONE EACH IN OCTOBER AND DECEMBER 1995. CO CONTACTED IN ALL EVENTS. MORE INTENSIVE "PM" PROGRAM TO PREVENT PROBLEM.
WHEN PLACING PICC LINE, THE PT DEMONSTRATED SYMPTOMS OF HIVES AND A FLUSHED APPEARANCE. THE SYMPTOMS SUBSIDED IN ABOUT 10 MINUTES AFTER RECEIVING 25 MG BENADRYL.
THE FINGER GRIP TABS AREA TEARING THROUGH THE STERILE PACKAGE OF 60 CC BULB IRRIGATION SYRINGES. THIS HAS HAPPENED SEVERAL TIMES IN THE PAST FEW WEEKS. RPTR ALSO HAD ONE WITH A TEAR IN THE PACKAGE AT THE TIP OF THE BULB SYRINGE. THIS IS A DISPOSABLE ITEM SO THE CONTENTS ARE CONTAMINATED AND UNUSABLE. RPTR HAS NOT EXPERIENCED THIS PROBLEM WITH PREVIOUS BRANDS OR WITH THIS BRAND UNTIL RECENTLY. TORN PACKAGES WITH CONTENTS AND A COPY OF THIS REPORT WILL BE GIVEN TO THE LOCAL DISTRIBUTOR.
WHILE TRANSFERRING RESIDENT PER ELECTRIC LIFT FROM BED TO W/C, LIFT SHEET LOOP BROKE, CAUSING RESIDENT TO FALL TO THE FLOOR, BUMPING RIGHT SIDE OF HEAD AND RIGHT EAR ON LEG OF ELECTRIC LIFT. RESIDENT RECEIVED A LACERATION TO THE SCALP 3.8 CM IN LENGTH.
VELCRO STRAPS HAVE COME UNGLUED FROM COLLAR ON MORE THAN 3 OCCASIONS. USED TO BRACE PT'S NECK FOLLOWING CERVICAL FUSIONS. IN RPTR'S OPINION, THE CO HAS NOT RESPONDED QUICKLY OR APPROPRIATELY.
SPONGE FRAGMENTED IN WOUND. PT DID NOT REQUIRE MEDICAL TREATMENT. THERE WAS NO INJURY.
RPTR HAS HAD PHYSICIAN COMPLAINTS REGARDING THE 10 ML GLASS SYRINGE FROM THE CONTINUOUS EPIDURAL TRAY HAVING RESISTANCE OR "STICKING." THIS MAKES IT DIFFICULT FOR THE PHYSICIAN TO FEEL WHERE THE NEEDLE IS LOCATED AND THE PHYSICIAN HAS TO APPLY PRESSURE TO THE PLUNGER CAUSING THE NEEDLE TO ENTER FURTHER THAN ANTICIPATED.
CR BARD, INC. 8195 INDUSTRIAL BLVD, COVINGTON, GA 30209-2695. AN MDR INJURY REPORT WAS FILED ON THIS EVENT ON 1/30/96, ACCESS NUMBER M745505.
BASED UPON THE INFO RECEIVED FROM THE CUSTOMER THE EVENT WAS JUDGED NOT TO BE REPORTABLE UNDER THE MDR RULES.
TWO INCIDENTS OF PRODUCT FAILURE: 1) WHILE IN USE, CATHETER BEGAN TO LEAK. LEAK OCCURRED IN CANNULA NOT HUB. 2) WHILE IN USE, THE HUB CRACKED. DEPT CONTACTED MFR. THEY HAVE NOT BEEN RESPONSIVE.
RPTR C/O DISABILITY OF NECK, BACK, ARM AND LEG JOINTS, CHRONIC FATIGUE, FIBROMYALGIA, SCLERODERMA, DISC PROBLEMS, SLEEP DISORDER AND DEPRESSION.
CARDIOPULMONARY ARREST DISCOVERED AND RESUSCITATION STARTED. PT WAS RECEIVNG 3 TPN VIA CATHETER PLACED IN RIGHT SUBCLAVIAN VEIN USING 1 PORT. NURSE NOTED TUBING OF FILTER HAD SEPARATED AT Y-SITE WITH SMALL AMOUNT OF TUBING LEFT ATTACHED TO CATHETER. THERE WAS BLOOD LOSS BUT THE AMOUNT COULD NOT BE QUANTIFIED. PT RESPONDED TO FLUIDS AND DRUG THERAPY, BUT REMAINED IN A VEGETATIVE STATE. EXPIRED 12/22/95. (*)
LAB BLOOD CULTURE MEDIUM CONTAINED GRAM-POSITIVE BACTERIA THAT WERE NOT VIABLE, BUT LED RPTR TO CONCLUDE THAT THEY WERE IN THE CULTURE OF THE PT'S SPECIMEN. ONLY ONE LOT OF MEDIA WAS AFFECTED. 10 BOTTLES WHICH WERE KNOWN TO BE NEGATIVE FOR GROWTH OF ORGANISMS WERE GRAM STAINED AND FOUND TO CONTAIN GRAM-POSITIVE COCCI. TEN BOTTLES FROM A DIFFERENT LOT NUMBER WERE FOUND TO BE NEGATIVE BY GRAM STAIN. FOR TWO PTS, POSITIVE REPORTS WERE GIVEN TO THE PHYSICIANS. UNTIL THE PROBLEM WAS RESOLVED THOSE REPORTS REMAINED IN THE PT'S CHART. IN ONE CASE, THE REPORT WAS IN THE COMPUTER FOR 2 WEEKS; IN THE OTHER, FOR 4 DAYS.
ON TUESDAY, 12/26, RPTR WENT TO THE PT'S HOME AND THE RPTR AND HUSBAND CHANGED THE ONE LITER BAG OF FENTANYL PER PUMP INSTRUCTIONS. THE DRUG WAS BEING ADMINISTERED EPIDURALLY. ON 12/29, WHEN HUSBAND AND RPTR WENT BACK TO CHANGE THE BAG, THE BAG WAS COMPLETELY FULL. NO MEDICATION HAD INFUSED. DURING THE THREE-DAY PERIOD THE PT HAD BEEN IN PAIN AND OTHER MEDICATIONS HAD BEEN USED TO TRY TO CONTROL THE PAIN. RPTR STATES THAT THE MFR HAS CHANGED THE TUBING THAT ATTACHES TO THE PUMP. THE TUBING IS VERY SHORT, ABOUT 6" LONG. THE TUBING BETWEEN THE BAG AND THE PUMP HAD GOTTEN FOLDED OVER OR CRIMPED, SO THE MEDICATION WOULD NOT INFUSE. RPTR HAS TALKED TO THE MFR ABOUT THIS PROBLEM.
RPTR PURCHASED A NEW PAIR OF CONTACT LENSES IN JULY. SHE USED THESE LENSES WITH CLEANING SOLUTION. THE LENSES SLOWLY TURNED DARK BROWN (THEY WERE CLEAR LENSES ORIGINALLY). THEY WERE UNCOMFORTABLE TO WEAR. HER DOCTOR TOOK THEM BACK, GAVE HER A NEW PAIR AND AGAIN, THE SAME THING HAPPENED, EXCEPT HER VISION WAS NOT AS CLEAR. HER DOCTOR CHECKED HER EYES AND SAID THEY APPEAR TO BE OKAY AND WITHOUT PROBLEM. ON 12/13/95 SHE CALLED THE MFR'S SALES REPRESENTATIVE AFTER RECEIVING A LETTER FROM THE SOLUTION MFR REGARDING THE CHEMICAL REACTION OF THE LENSES WITH THE SOLUTION. THE SALES REP STATED, "THERE IS NO EVIDENCE OUT THERE THAT SAYS SORBIC ACID MADE THE LENS CHANGE COLOR." RPTR HAS LEARNED FROM HER DOCTOR THAT THE MFR DOES KNOW THIS IS A PROBLEM BUT HAS NEVER COMMUNICATED THIS TO PHYSICIANS OR PATIENTS. CONSUMERS NEED TO KNOW SO THEY CAN MAKE INFORMED DECISIONS. FROM A LETTER FROM THE SOLUTION MFR: "IN AN ATTEMPT TO INVESTIGATE THE CONDITION DESCRIBED, QUALITY ASSURANCE ANALYZED THE RETURNED PRODUCTS. TESTING DETERMINED THAT THE DAILY CLEANER WAS WITHIN ALL SPECIFICATION REQUIREMENTS WITH NOTHING UNUSUAL NOTED. ALTHOUGH THE AMOUNT OF MULTI PURPOSE RETURNED WAS INSUFFICIENT TO PREFORM ALL TESTS, THE TESTING THAT WAS COMPLETED WAS FOUND TO MEET SPECIFICATION REQUIREMENTS. REGARDING THE PT'S LENSES, VISUAL OBSERVATION NOTED A YELLOW COLOR. AS STATED IN RPTR MOST RECENT CONVERSATION, PER THE LENS MFR, NO PRODUCTS CONTAINING SORBIC ACID OR POTASSIUM SORBATE SHOULD BE USED AS A SOAKING AGENT WITH THE LENS MATERIAL. PLEASE BE AWARE THAT IT IS THE RESPONSIBILITY OF THE LENS MFR TO PROVIDE THE LENS DISPENSER WITH SPECIFIC INFO CONCERNING THE APPROVED CARE AND CLEANING REGIMEN. WE WOULD LIKE TO RECOMMEND THAT THE PT'S LENS CARE ROUTINE BE REVIEWED IN DETAIL." (*)
PT HAD A MASTECTOMY 10/24/95 DURING WHICH A DRAIN WAS PLACED. THE DRAIN WAS PULLED ON OR ABOUT 10/27/95, PT WAS DISMISSED 10/28/95 AND WAS FOLLOWED IN THE CLINIC. PT WAS READMITTED TO THE HOSP 12/4/95 WITH CELLULITIS AND AN INFECTED SEROMA OF THE CHEST. X-RAY ON 12/7/95 INDICATED THE DISTAL END OF THE DRAIN REMAINED IN THE PT'S CHEST AND SOMEHOW HAD BROKEN OFF PRIOR TO REMOVAL OF THE DRAIN BACK IN 10/95. PT WAS TREATED FOR THE INFECTION, DISMISSED AND WILL BE RESCHEDULED FOR REMOVAL OF THE REMAINING PART OF TUBE AT A LATER DATE.
RPTR C/O SEVERE HIVES, SWELLING OF JOINTS, PAIN, SEVERE HEADACHES, HEART PALPITATIONS NERVOUSNESS, SHAKING, BLURRED VISION, AND GOITER THAT HAD TO BE TREATED WITH RADIOACTIVE IODINE. BOTH IMPLANTS HAD RUPTURED, AND LEAKED SILICONE INTO RPTR'S SYSTEM. SHE WAS A VERY HEALTHY PERSON BEFORE THIS SURGERY. THE DOCTOR INFORMED HER OF THE BENEFITS OF IMPLANTS. HE ALSO TOLD HER YOU COULD STOMP ON AN IMPLANT AND IT WOULD NOT BREAK. SHE HAS SEEN FIFTEEN DOCTORS. SHE HAS BEEN DIAGNOSED WITH GRAVE'S DISEASE, LUPUS AND ARTHRITIS. SHE WILL BE ON MEDICATION FOR THE REST OF HER LIFE. (*)
ON 2/26/79 RPTR'S DOCTOR PERFORMED A BILATERAL SUBCUTANEOUS MASTECTOMY AND IMMEDIATE INSERTION OF PROSTHESES. SHE HAD NO PAIN NOT EVEN FROM THE LUMPS. THE PAIN STARTED AFTER THE FIRST IMPLANTS. AFTER A FEW MONTHS THESE IMPLANTS STARTED GETTING VERY HARD, ROUND AND TIGHT LIKE A BASEBALL. IN EARLY 1982 THE DOCTOR REMOVED THE IMPLANTS AND SHE BELIEVES HE SAID HE WOULD PLACE THE IMPLANTS UNDER THE BREAST MUSCLES TO CORRECT THIS PROBLEM. THE SECOND OPERATION DID NOT CORRECT HER PAIN PROBLEM. SHE QUESTIONED THIS PAIN IN RELATION TO HER IMPLANTS WITH SEVERAL DOCTORS BUT THEY HAD NO ANSWER FOR THE PROBLEM. IT STARTED GRADUALLY EVERY TWO TO THREE MONTHS WITH SUDDEN, SEVERE CRUSHING CHEST PAIN, WEAKNESS, FATIGUE HEADACHES, MEMORY, CONCENTRATION PROBLEMS AND NUMBNESS AND TINGLING IN THE EXTREMITIES. THE PAIN STARTS IN THE CHEST RADIATES UP TO THE NECK OVER THE LEFT SHOULDER DOWN THE LEFT SHOULDER, LEFT ARM AND SOMETIMES INTO THE LEFT LEG. SHE HAS THE PAIN CONSTANTLY NOW. ABOUT EVERY THREE TO FOUR DAYS SHE MUST HAVE A TORADOL SHOT TO EASE THE PAIN. ON 5/27/91 SHE SUDDENLY HAD RATHER SEVERE GRAND MAL TYPE SEIZURE ACTIVITY WHICH LASTED FOR SEVERAL MINUTES. SHE WAS EVALUATED AND THOUGHT TO HAVE HAD AN UNEXPLAINED GRAND MAL SEIZURE AND WAS IN A POSTICTAL STATE. ON 7/17/91 SHE WAS SEEN FOR A SEVERE NEUROLOGIC EVENT. SHE HAD BEEN HAVING SEVERE NECK, UPPER BACK, SHOULDER, AND UPPER EXTREMITY PAINS AT HOME AND WAS EXPERIENCING CONSIDERABLE PROBLEMS WITH THIS. SEVERAL TESTS WERE PERFORMED SUCH AS MRIS, CAT SCAN, NEUROLOGY ETC, WITH NO FAVORABLE SOLUTION. IT WAS A THOUGHT SHE MIGHT HAVE CONTRACTED ENCEPHALITIS SOMEWHERE BUT THAT WAS RULED OUT IN NEUROLOGIC CONSULTATION AND EVALUATION ON 7/8/91. ON 4/1/90 SHE WAS FORCED TO RETIRE EARLY DUE TO HER TREMULOUSNESS AND NERVES. HER ILLNESS DID NOT IMPROVE AND IN 11/91 SHE WAS AWARDED SOCIAL SECURITY DISABILITY BECAUSE OF HER DETERIORATING HEALTH. IN SUMMARY, SHE HAS SUFFERED 15 YEARS WITH WHAT SHE WOULD CALL IMPLANT POISONING. THE DOCTOR SAYS IT ISN'T THE IMPLANTS BECAUSE THEY ARE SALINE. SHE DOES NOT BELIEVE THIS, BECAUSE EVERY TEST GIVEN HAS SHOWN UP NEGATIVE. HER HUSBAND AND SHE ARE STRESSED OUT AND ARE NERVOUS WRECKS. (*)
LINEAR ACCELERATOR HAS TWO SETS OF ELECTRON TRIMMERS. ONE SET OF TRIMMERS IS DESIGNED TO COVER ALL POSSIBLE FIELD SIZES. THIS IS THE LARGER SET OF TRIMMERS. THE SECOND, SMALLER SET OF ELECTRON TRIMMERS IS DESIGNED TO BE USED FOR FIELD SIZES UP TO TEN CENTIMETERS SQUARED. HOWEVER, THE FIELD SIZE CAN BE INCREASED TO THIRTY CENTIMETERS SQUARED WITH THE SMALL TRIMMERS. ANY FIELD SIZE GREATER THAN TEN CENTIMETER SQUARED, IS NO LONGER DEFINED BY THE ELECTRON TRIMMERS. THIS CAN AND WILL PRODUCE A SERIOUS MISAPPLICATION. (*)
RPTR HAD SILICONE IMPLANTS PUT IN IN 1985. SHE WAS "SICK" THE WHOLE TIME SHE HAD THEM AND HAD THEM REMOVED IN 1987, UNDER PROTEST OF HER PLASTIC SURGEON WHO TOLD HER "NO WAY COULD IMPLANTS CAUSE PROBLEMS." SHE NOW HAS SJOGREN'S AND SILICONE LUPUS; SHE HAS BEEN DISABLED FOR THE PAST 6 YEARS. SHE HAS GAINED 50 POUNDS, CANNOT EXERCISE AND HAS SEVERE HIGH BLOOD PRESSURE AS A RESULT.
RPTR C/O CHEST/RIB CAGE PAIN AND /OR BURNING SENSATION AND INFLAMMATION, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, CONNECTIVE TISSUE DISEASE, CHRONIC UNEXPLAINED MUSCLE SPASMS, MUSCLE PAIN AND BURNING, FIBROMYLAGIA, GRANULOMAS OR SILICONOMAS AND CHRONIC INFLAMMATORY RESPONSE. RPTR HAD BIOPSIES DONE ON TISSUE SAMPLES EXAMINED PATHOLOGICALLY. A MEDICAL PROFESSIONAL HAS CONFIRMED SILICONE OUTSIDE THE BREAST SCAR TISSUE CAPSULE IN THE BREAST TISSUE. IN SURGICAL AREA SHE HAD INFECTION, EXCESS FLUID AND NUMBNESS (NIPPLE OR BREAST). THE IMPLANTS WERE RUPTURED. SHE HAD BLEEDING THROUGH THE ENVELOPE. SHE HAD 2 CAPSULAR CONTRACTURES AND 2 CLOSED CAPSULOTOMIES. (*)
BOLTS MOUNTING GANTRY AND COUNTER WEIGHT DRUM TO THE WALL WERE FOUND TO BE LOOSE.
POST LARYNGECTOMY SURGERY. DRAIN NOT FUNCTIONING. BLOCKED DRAINAGE SYSTEM. RPTR REQUESTS MFR'S REPORT.
TIP BROKE OFF DURING PROCEDURE. RPTR REQUESTS MFR'S REPORT. THIS IS THE 3RD EVENT. INFO AND DEVICE NOT SAVED FOR TWO EVENTS. (*)
PT SUSTAINED HIP FRACTURE AFTER A FALL. UNDERWENT HIP PINNING 6/24/95. PT C/O PERSISTENT PAIN. X-RAY TAKEN, WHICH SHOWED 5 SCREWS BROKEN ON THE 8-HOLE PLATE. PT HAD TO HAVE REVISION OF HIP PINNING. ON 10/13/95. X-RAY REVIEWED LEG ORTHOPEDIC SURGEONS AT ROUNDS QUESTIONABLE HARDWARE FAILURE. PT'S FAMILY HAS BROKEN SCREWS. HEADS APPEAR TO HAVE BROKEN OFF. THE 3 THAT DID NOT BREAK WERE FROM ANOTHER LOT.
PT HAD PLACEMENT OF INDWELLING INTRAVENOUS LINE. WITHIN 5 MINUTES, PT DEVELOPED ACUTE ALLERGIC REACTION WITH DIFFUSE REDNESS, BLOTCHING AND HIVES. RESPONDED TO REMOVAL OF IV AND BENADRYL 25 MG IV X 1 (WAS FLUSHED WITH HEPARIN).
REGISTERED NURSE VISITED PT AT HOME TO INSERT CATHETER AND INITIATE VANCOMYCIN INFUSION. PICC WAS CUT TO LENGTH OF 14" AND INSERTED INTO BASILIC VEIN. WITHIN 1 MINUTE OF INSERTION, PT COUGHED FORCEFULLY AND LOST CONSCIOUSNESS. REMAINED UNCONSCIOUS, BECAME SEVERELY SHORT OF BREATH AND CYANOTIC WITH HYPOTENSION. 911 WAS CALLED AND PT TRANSPORTED TO HOSP. PT REMAINED HOSPITALIZED AS OF 12/26/95. (CATHETER WAS NOT UTILIZED AS CENTRAL ACCESS DEVICE, BUT AS MIDLINE CATHETER).
EXTERNAL PACER IN USE. SEVERAL TIMES MACHINE FLASHED "PACER LEADS OFF." EACH TIME POWER TO PACER WAS OFF. MACHINE WAS PLUGGED IN AND ALL LEADS WERE PATENT.
PT HAD RUPTURED BILATERAL BREAST IMPLANTS (GEL IMPLANTS). RPTR IS NOT SURE WHY. THEY WERE IMPLANTED 14 YEARS AGO. RPTR DOES NOT KNOW HOW LONG IMPLANTS LAST.
BECTON DICKINSON VASCULAR ACCESS, 9450 SOUTH STATE ST, SANDY, UT 84070. THANK YOU FOR LETTING US KNOW THAT THE TUBING SEPARATED FROM THE ADAPTER ON A T PORT UNIT. ALSO REPORTED WERE INCOMPATIBLE LUER FITTINGS. THANK YOU FOR TAKING THE TIME TO REPORT AND FOR RETURNING THE PRODUCT FOR ANALYSIS. RECEIVING DIRECT FEEDBACK FROM OUR CUSTOMERS IS HELPFUL IN ENSURING THAT OUR PRODUCT MEETS OUR CUSTOMERS IS HELPFUL IN ENSURING THAT OUR PRODUCT MEETS OUR QUALITY STANDARDS AND OUR CUSTOMERS' EXPECTATIONS. THE QUALITY ENGINEER WITH RESPONSIBILITIES FOR THE T PORT PRODUCT EXAMINED THE SAMPLE RETURNED. THE TUBING WAS NOT ADEQUATELY BONDED TO THE INSERTER. WE HAVE MADE PROCESS IMPROVEMENT TO THE BONDING OPERATION TO ENSURE THAT THIS JUNCTION IS MORE RELIABLE,SINCE THE MFR OF THIS MARCH 1994 PRODUCT. WE WILL CONTINUE TO MONITOR OUR PROCESSES AND PROCEDURES TO ENSURE THERE IS NO RECURRENCE OF THIS INCIDENT. QA AND MFG PERSONNEL HAVE BEEN NOTIFIED OF YOUR REPORT AND OUR FINDINGS. NO PRODUCT WAS RETURNED FOR TESTING OF THE LUER FITTINGS. LOT HISTORY FILES WERE REVIEWED AND NO PROBLEM WAS SEEN WITH LUER DIMENTIONS. WE HAVE SEARCHED OUR PRODUCT INCIDENT REPORTS AND WE HAVE RECEIVED NO OTHER REPORTS OF INCOMPATIBLE LUER FITTING OR ADAPTER/TUBING SEPARATION ON THE T-PORT PRODUCT IN THE PREVIOUS 12 MONTHS. WE ARE HOPEFUL THAT THE PRODUCT YOU ARE USING AT THIS TIME IS MEETING YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. PLEASE ACCEPT OUR APOLOGIES FOR THE INCONVENIENCE AND THE CONCERN IT CAUSED. YOUR SATISFACTION IS VERY IMPORTANT TO US AND YOUR REPORT IS APPRECIATED.
THIS LETTER IS TO ACKNOWLEDGE RECEIPT OF THE SUBJECT REPORT AND TO ADVISE THAT THE MATTER IS BEING APPROPRIATELY ADDRESSED.
APPROX 20 MINUTES AFTER PROCEDURE, RAISED BLISTERS APPEARED IN ALL 53 PLACES WHERE LASER HAD BEEN APPLIED. BURNS WERE 1/2" X 1 1/2" IN SIZE, CONSISTENT WITH SIZE OF OPENING ON MACHINE. RPTR WAS TREATED AT AN OUTPATIENT BURN CENTER. SHE HAS SOME SCARRING. SEVERAL CAPILLARIES HAVE RUPTURED AND NOW APPEAR AS SOLID RED AREAS. RPTR STATES PHOTOGRAPHS OF HER LEGS WERE TAKEN PRIOR TO PROCEDURE BUT A SAMPLE AREA WAS NOT TREATED TO DETERMINE IF BURNS WOULD OCCUR. RPTR HAS OLIVE SKIN. RPTR STATES TREATING PHYSICIAN HAS BROCHURES FROM CO WHICH HE DOES NOT FEEL SHOULD BE GIVEN OUT DUE TO THE INACCURATE INFO CONTAINED IN THE BROCHURES. ACCORDING TO PHYSICIAN 97% OF ALL PTS RECEIVING NON-SURGICAL LASER TREATMENT FOR BROKEN CAPILLARIES REPORT NO SIDE EFFECTS. ALSO STATES LASER "FOLLOWS" RED AND SHE MAY NOT HAVE BEEN AN APPROPRIATE CANDIDATE FOR PROCEDURE DUE TO OLIVE SKIN.
PT ADMITTED TO HOSP WITH CHEST AND BACK PAIN FOLLOWING SYNCOPAL EPISODE. ON ADMISSION, PT WAS BRADYCARDIAC WITH 2.1 SECOND EPISODES OF ASYSTOLE. IT WAS DETERMINED THAT PT NEEDED A TRANSVENOUS PACEMAKER. FOLLOWING SURGERY PT C/O RIGHT ARM PAIN WHICH WAS TREATED WITH PAIN MEDICATIONS. ATRIAL FIBRILLATION DEVELOPED. THE PACEMAKER DID NOT APPEAR TO BE WORKING. ATRIAL FIBRILLATION WAS DIFFICULT TO CONTROL. PT WAS CARDIOVERTED MULTIPLE TIMES. THERE WAS NO TIMES TO REPLACE PACEMAKER AND PT EXPIRED. (ALSO SEE 1008090, 1008091).
WE RECEIVED A COPY OF MEDWATCH FORM #1008090 FOR FOLLOW-UP. THE FORM STATED THE PT WAS ADMITTED TO THE HOSP WITH CHEST AND BACK PAIN FOLLOWING A SYNCOPAL EPISODE. ON ADMISSION, THE PT WAS BRADYCARDIC WITH 2.1 SECS EPISODES OF ASYSTOLE. A PACEMAKER WAS IMPLANTED. THE PT DEVELOPED ATRIAL FIBRILLATION ON 1/7/95. "THE PACEMAKER WAS IMPLANTED. THE PT DEVELOPED ATRIAL FIBRILLATION ON 1/7/95. "THE PACEMAKER DID NOT APPEAR TO BE WORKING. ATRIAL FIBRILLATION WAS DIFFICULT TO CONTROL. PT WAS CARDIOVERTED MULTIPLE TIMES. THERE WAS NOT TIME TO REPLACE PACEMAKER AND PT EXPIRED." THE REPORT WAS TAKEN BY TELEPHONE AND THE RPTR'S REQUESTED THEIR IDENTITY NOT BE DISCLOSED TO THE MFR. THE SERIAL # OF THE MODEL 4024 LEAD WAS ALSO NOT DISCLOSED. IT APPEARS THE SERIAL # WAS COVERED WITH TAPE. WE FOLLOW THE PERFORMANCE OF OUR PRODUCTS CLOSELY. WE WOULD APPRECIATE RECEIVING THE SERIAL # OF THIS LEAD.
PT ADMITTED TO HOSP WITH CHEST AND BACK PAIN FOLLOWING SYNCOPAL EPISODE. ON ADMISSION PT WAS BRADYCARDIC WITH 2.1 SECOND EPISODES OF ASYSTOLE. IT WAS DETERMINED THAT PT NEEDED A TRANSVENOUS PACEMAKER. FOLLOWING SURGERY PT C/O RIGHT ARM PAIN WHICH WAS TREATED WITH PAIN MEDICATIONS. ON 1/7/96 ATRIAL FIBRILLATION DEVELOPED. THE PACEMAKER DID NOT APPEAR TO BE WORKING. ATRIAL FIBRILLATION WAS DIFFICULT TO CONTROL. PT WAS CARDIOVERTED MULTIPLE TIMES. THERE WAS NO TIME TO REPLACE PACEMAKER AND PT EXPIRED. (ALSO SEE 1008089, 1008090).
LAP SPONGES ON C-SECTION PACK HAVE BEEN CONTAMINATED. THEY ARE DIRTY YELLOW AND HAVE A FOUL ODOR.
US FILTER CORP. 10 TECHNOLOGY DR, LOWELL, MA 01851. ON 1/24/96, US FILTER RECEIVED A COPY OF ATTACHED MEDWATCH REPORT (ACCESS # 1008093) WHICH HAD BEEN FORWARDED TO US BY YOUR OFFICE OF SURVEILLANCE AND BIOMETRICS. ALTHOUGH NO DEATHS OR SERIOUS INJURIES OCCURRED AS A RESULT OF THIS INCIDENT, CUSTOMER HAS REFUSED TO PROVIDE US WITH NECESSARY INFO TO DETERMINE CONCLUSIVELY WHETHER OR NOT MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF MALFUNCTION WERE TO RECUR. US FILTER HAS UNDERTAKEN AN EXTENSIVE INVESTIGATION TO DETERMINE POTENTIAL CAUSES OF PROBLEM. RESULTS OF OUR INVESTIGATION ARE AS FOLLOWS: COMMUNITY DIALYSIS CTR (VIVRA RENAL CARE) HAS BEEN A US FILTER CUSTOMER SINCE 4/95. WE PROVIDE THEM WITH TWO, 1.2 CUBIC FOOT MIXED BED DI RESIN TANKS ON AN AS REQUESTED BASIS. TANKS ARE USED ONLY IN EVENT THAT THEIR PRIMARY WATER SYSTEM GOES DOWN AND ARE INSTALLED BY DIALYSIS CENTER TECHNICIANS IF NECESSARY. PRIMARY WATER SYSTEM EQUIPMENT AS WELL AS OTHER EQUIPMENT OR INSTRUMENTATION USED AS PART OF BACK-UP SYSTEM WERE NOT PROVIDED NOR ARE THEY SERVICED BY US FILTER. ON 11/17/95 CUSTOMER REUQESTED US FILTER TO PROVIDE NEW TANKS. ON 11/18, TWO 1.2 CU FT TANKS, SERIAL # 27501 AND 27569 EACH CONTAINING RESIN FROM BATCH # 8211 WERE DELIVERED TO COMM DIALYSIS. ON 12/30, US FILTER RECEIVED A CALL FROM DIALYSIS CTR STATING THEY NOTICED AN ODOR OF CHLORINE WHEN THEY WENT TO HOOK UP BACK-UP DI TANKS. A SVC TECH WAS IMMEDIATELY DISPATCHED TO LOCATION WITH TWO NEW DI TANKS. UPON ARRIVAL AT CUSTOMER SITE, THE SVC TECH WAS SHOWN RESULTS OF CHLORINE TEST WHICH HAD BEEN PERFORMED BY DIALYSIS TECH. RESULTS INDICATED PRESENCE OF CHLORINE. REPLACEMENT UNITS WERE THEN CHECKED FOR CHLORINE, FOUND TO BE NEGATIVE AND INSTALLED BY US FILTER SVC TECH. CUSTOMER REFUSED TO LET OUR SVC TECH TAKE DI TANKS BACK WITH CHLORINE ODOR. SUBSEQUENT TO THIS INCIDENT, US FILTER HAS TRIED TO REPRODUCE EVENTS WHICH WOULD HAVE HAD TO OCCUR DURING OUR PROCESSING OF TANKS TO ALLOW A TANK TO BE DELIVERED WITH CHLORINE STILL PRESENT. SINCE THE TWO DI TANKS IN QUESTION SAT AT THE CUSTOMERS LOCATION FOR OVER 6 WEEKS AND SINCE CUSTOMER REFUSES TO PROVIDE US WITH ANY OF THEIR MAINTENANCE LOGS AND OR A PROCESS AND INSTRUMENTATION DIAGRAM OF THE OTHER EQUIPMENT ON-SITE, IT IS POSSIBLE THAT THE CHLORINE CONTAMINATION COULD HAVE OCCURRED WHILE THE DIALYSIS CTR WAS IN POSSESSION OF THE TANKS. AT THIS POINT WE ARE UNABLE TO CONCLUSIVELY STATE THE CAUSE OF THIS PROBLEM. WE ALSO NOTE THAT THE PROBLEM HAS NOT PREVIOUSLY OCCURRED. HOWEVER, WE HAVE REVIEWED THE SUBJECT PROCEDURES WITH ALL PERSONNEL INVOLVED IN THIS OPERATION TO ASSURE COMPLIANCE WITH ALL REQUIRED STEPS.
AT 14:47 HRS ON 12/27/95 RPTR PLACED THIS PT ON CARDIOPULMONARY SUPPORT (CPS). THIS IS AN EMERGENCY PROCEDURE THAT WAS REQUIRED BECAUSE RPTR WAS NOT ABLE TO WEAN PT FROM CONVENTIONAL HEART-LUNG BYPASS FOLLOWING CORONARY ARTERY BYPASS SURGERY. THE OXYGENATOR IN QUESTION WAS PRIMED IN THE NORMAL FASHION AND CONNECTED TO THE PT WITHOUT INCIDENT. AT ABOUT 17:00 HRS IT WAS NOTED THAT BLOOD FLOW TO THE PT WAS SIGNIFICANTLY REDUCED AND THAT THE OXYGENATOR SEEMED TO BE OBSTRUCTED. A SECOND OXYGENATOR WAS PRIMED AND USED AS A REPLACEMENT. THERE WERE NO FURTHER UNUSUAL PROBLEMS ASSOCIATED WITH OXYGENATION OR BLOOD FLOW. RPTR RINSED IT WITH SALINE THE NEXT DAY AND PLACED IT IN THE REFRIGERATOR BETWEEN ROOMS 17 AND 18 IN THE OR. EVIDENCE OF BLOOD CLOTS WERE APPARENT. RPTR HAS CALLED THE CO REP TWICE NOW WITHOUT RESPONSE. AS OF 12:30 12/30/95 RPTR CONTACTED THE MAIN CO AND THEY HAVE PROMISED TO RESPOND QUICKLY.
11/11/95 DR BEGAN TO INSERT A BIPOLAR RIGHT HIP PROSTHESIS. DR NOTED THAT AFTER THE SKIN INCISION WAS MADE AND CAUTERY WAS REQUIRED, THAT THE CAUTERY WAS INTERFERING WITH THE PT'S PACEMAKER ON THE HEARTBEAT. BOVIE UNIT WITH SETTINGS OF COAG 55/CUT 75 CAUSED PT TO GO INTO AYSTOLE. BOVIE UNIT WAS CHANGED BUT PT CONTINUED TO HAVE DISTURBANCE OF THE HEARTBEAT EVERY TIME DR ATTEMPTED TO USE THE BOVIE. MAGNET WAS PLACED OVER PACEMAKER AND SITUATION CORRECTED.
TRAVEL CHAIR PURCHASED IN 1993 PRESENTS WITH THE FOLLOWING PROBLEMS: A) WHEELS DO NOT ROLL FREELY. B) PT'S FOOT GETS CAUGHT BETWEEN THE WHEEL AND THE BODY OF THE CHAIR. C) SAFETY AND SECURITY BELTS ARE NOT SECURE AND DON'T PROVIDE OPTIMUM SAFETY FOR USER. D) HEAD REST DOES NOT ADJUST TO USER, COMES OFF EASILY AND DOES NOT STABILIZE HEAD. E) WEIGHT OF CHAIR IS NOT USER-FRIENDLY, CONTRIBUTING TO CAREGIVER INJURY.
11/2/95 WHILE UNDER EPIDURAL ANESTHESIA, THE PT UNDERWENT AN ELECTIVE D&C, ENDOMETRIAL ABLATION AND HYSTEROSCOPY. TOWARD THE END OF THE PROCEDURE DR NOTED THAT THE PT JERKED WHEN THE CAUTERY WAS USED. THE SURGICAL STAFF CHECKED THE BOVIE AND THEN CHANGED THE BOVIE CORD. THE CASE WAS CONCLUDED. THE PT LEFT SURGERY WITH NO ILL EFFECTS.
DISPOSABLE AMBU BAG MALFUNCTION. CO2 TIDAL DETECTOR BROKE DURING USE. SECOND SUCH INCIDENT IN 12 MONTHS.
ON 8/15/95, A 78-YR-OLD MALE HAD A VENA CAVA FILTER INSERTED. ON 8/21/95, HE WAS READMITTED AND TRANSFERRED TO A MEDICAL CTR FOR REMOVAL OF THE FILTER, WHICH HAD MIGRATED TO THE RIGHT PULMONARY ARTERY.
THE NEW MODEL'S SPRING DOES NOT HOLD AS LONG AS THE ORIGINAL MODEL IN ORDER TO GET GOOD PENETRATION NEEDED TO DRAW BLOOD. SHOULD BE GOOD FOR FIVE YEARS AND IT IS ONLY LASTING THIRTY DAYS.
PICC INSERTION COMPLETED WITHOUT DIFFICULTY ADVANCING CATHETER. EXCELLENT BLOOD RETURN. FLUSHED W/NS AND HEPARIN 100 U/CC, 2.5 CC. UNABLE TO REMOVE GUIDE WIRE. STAT PORTABLE CXR DONE TO CHECK FOR COIL IN LINE OR OTHER REASON FOR STUCK GUIDE WIRE. X-RAY REVEALED NO KINKS OR COILING IN CATHETER. CATHETER WAS REMOVED. GUIDE WIRE PROBLEM WAS NOT RESOLVED NOR COULD GUIDE WIRE BE REMOVED FROM CATHETER EVEN AFTER REMOVAL FROM PT.
LEFT SILICONE BREAST IMPLANT FOUND TO BE RUPTURED UPON EXPLANTATION. IMPLANT REMOVED.
BREAST IMPLANT RUPTURED LEADING TO DISFIGUREMENT AND SILICONE LEAK INTO BODY. MAMMOGRAM DID NOT SHOW RUPTURE, MRI OF CHEST SHOWED RUPTURE. REMOVED 8/24/94. SHE HAS HAD NO TREATMENT AT THIS TIME TO CLEAN BLOOD OR TISSUE OF SILICONE.
FEEDING CHAIR PRESENTS WITH THE FOLLOWING PROBLEMS: A) FEEDING CHAIR HEIGHT IS TOO LOW TO ALLOW SAFE TRANSFER OF USER WITHOUT POTENTIAL INJURY TO USER AND CAREGIVER. B) CHAIR DOES NOT HAVE ARMREST TO SECURE USER AND PREVENT FALLS. C) THE SAFETY AND SECURITY BELTS ARE POSITIONED TOO HIGH, CONTRIBUTING TO POTENTIAL INJURY BY STRANGULATION. D) CHAIR IS NOT FLEXIBLE ENOUGH TO CONFORM TO THE POSTURE OF INDIVIDUAL PTS.
WHILE USING THE LIFT APPARENTLY THE NUT STRIPPED OFF BOLT ALLOWING PT TO FALL TO FLOOR.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  COMPONENT FAILURE, MECHANICAL PROBLEM.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE TEMPORARILY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AN 82-YR-OLD FEMALE ADMITTED ON 12/10/94 WITH A DIAGNOSIS OF ALZHEIMER'S, PSYCHOSIS, AND DEMENTIA. SHE WAS RESTRAINED AT NIGHT IN A WAIST RESTRAINT WITH (4) 1/2 RAILS UP ON THE BED. SHE WAS SEEN AT 9 PM AND AGAIN AT 10:15 PM SLEEPING IN THE BED. SHE WAS FOUND AT 10:50 PM WITH NO PULSE OR RESPIRATION. SHE WAS STILL IN THE RESTRAINT WHICH WAS UNDER HER BREASTS, FULLY OUT OF BED BETWEEN THE UPPER AND LOWER SPLIT RAIL WITH HER JAW RESTING ON THE UPPER RAIL AND HER BUTTOCKS APPROX 1 INCH OFF THE FLOOR. MEDICAL EXAMINER WAS CALLED AND AN AUTOPSY WAS PERFORMED, RESULTS INDICATED DEATH BY ASPHYXIATION. DEPT OF PUBLIC HEALTH WAS NOTIFIED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, A DEVICE FROM SAME LOT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AN 82-YR-OLD FEMALE ADMITTED ON 12/10/94 WITH A DIAGNOSIS OF ALZHEIMER'S, PSYCHOSIS, AND DEMENTIA. SHE WAS RESTRAINED AT NIGHT IN A WAIST RESTRAINT WITH (4) 1/2 RAILS UP ON THE BED. SHE WAS SEEN AT 9 PM AND AGAIN AT 10:15 PM SLEEPING IN THE BED. SHE WAS FOUND AT 10:50 PM WITH NO PULSE OR RESPIRATION. SHE WAS STILL IN THE RESTRAINT WHICH WAS UNDER HER BREASTS, FULLY OUT OF BED BETWEEN THE UPPER AND LOWER SPLIT RAIL WITH HER JAW RESTING ON THE UPPER RAIL AND HER BUTTOCKS APPROX 1 INCH OFF THE FLOOR. MEDICAL EXAMINER WAS CALLED AND AN AUTOPSY WAS PERFORMED, RESULTS INDICATED DEATH BY ASPHYXIATION. DEPT OF PUBLIC HEALTH WAS NOTIFIED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, A DEVICE FROM SAME LOT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  DEVICE FAILURE RELATED TO PATIENT CONDITION.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
X-RAY SHOWED PROBABLE DISINTEGRATION OF INSERT. COMPLETE SYNOVECTOMY PERFORMED, INSERT CUT OUT AND REPLACED, PATELLA REPLACED.
X-RAYS SHOWED A BROKEN TIBIAL PLATE. DURING REVISION SURGERY IT WAS NOTED THAT THE BONE GRAFT FROM THE PREVIOUS SURGERY HAD RESORBED AND THE LEFT MEDIAL SIDE OF THE TIBIAL PLATE WAS UNSUPPORTED.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. PATELLA WAS REPLACED WITH ANOTHER COMPONENT.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED WITH ANOTHER COMPONENT.
ONCE STYLET INSERTED, UNABLE TO DRAW STYLET BACK. BALLOON WAS INFLATED AND DEFLATED AND NEITHER THE STYLET NOR CATHETER COULD BE REMOVED WITHOUT TRAUMA TO PT. UNABLE TO PASS CATHETER TO BLADDER. REPLACED WITH A SECOND CATHETER. BLEEDING WAS NOTED." UNUSED SAMPLES FROM THE SAME LOT AS ALLEGEDLY FAILED PRODUCT WILL BE RETURNED TO MFR.
AIRWAY TUBE BROKE. THE AIRWAY WAS INSERTED INTO THE PT'S AIRWAY WITHOUT ANY DIFFICULTY, AND WAS WELL LUBRICATED. AT THE END OF THE PROCEDURE, AS THE PT WAS AWAKENING, THE MASK WAS REMOVED UNEVENTFULLY. UPON REMOVAL, IT WAS NOTED THAT THE MASK CRACKED APPROX 1 INCH FROM THE CONNECTOR (MASK DID NOT COMPLETELY BREAK APART). A BACK-UP MASK WAS USED TO COMPLETE THE PROCEDURE, AND NO PT INJURY OCCURRED.
PT HAD MRI SCAN OF LUMBAR SPINE WITH MONITORED ANESTHESIA. POST SCAN PT HAD THREE QUARTER-SIZE THIRD DEGREE BURNS WHERE MONITOR PATCHES HAD BEEN PLACED.
PT UNDERWENT BILATERAL EXPLANTATION OF SILICONE GEL-FILLED BREAST IMPLANTS AND REPLACEMENT WITH SILICONE GEL-FILLED IMPLANTS. BOTH EXPLANTED PROSTHESES WERE VISUALLY INTACT.
PT IN CARDIAC CATH LAB FOR ABLATION. CATHETER PRESENT IN RIGHT ATRIUM. WHILE PHYSICIAN WAS REPOSITIONING THE CATHETER UNDER FLUOROSCOPY, CATHETER TIP WAS NOTED TO BE DETACHED FROM CATHETER. PHYSICIAN ATTEMPTED RETRIEVAL; UNABLE TO RETRIEVE. PHYSICIAN CONTACTED MFR WHO STATED THAT PREVIOUS EXPERIENCE INDICATED CATHETER TIP COULD SAFELY BE LEFT IN CURRENT POSITION (WEDGED INTO CORONARY SINUS). PT KEPT OVERNIGHT FOR OBSERVATION; DISCHARGED HOME FOLLOWING DAY. CATHETER TIP AND APPROXIMATELY 2 MM OF CATHETER TUBING LEFT IN PT. (LABEL)
PT UNDERWENT EXPLANTATION OF RUPTURED BREAST IMPLANTS.
WHILE ATTEMPTING TO REMOVE A POLYP WITH A SNARE WIRE DURING A COLONOSCOPY. THE SNARE WIRE ATTACHED TO THE COLON WALL AND COULD NOT BE RETRIEVED.
SALINE TISSUE EXPANDER PLACED 11/13/95. EXPANDER LEAKING; REPLACED 12/8/95.
PT UNDERWENT BILATERAL EXPLANTATIONS OF DOUBLE LUMEN SILICONE BREAST IMPLANTS. BOTH PROSTHESIS HAD LEAKS.
PT GOT OUT OF BED BETWEEN THE SIDE RAILS(2-1/2 RAILS ON EACH SIDE) AND WAS FOUND LYING ON HER BACK ON THE FLOOR. THE BED ALARM HAD NOT SOUNDED TO WARN STAFF SHE WAS GETTING UP. OCCURRED AT 2350 PT REMAINED RESPONSIVE THROUGH THE NIGHT, BECAME LETHARGIC BY 0545 AND WAS UNRESPONSIVE AT 0730. SHE REMAINED UNRESPONSIVE UNTIL 1800 12/3/95.
PT UNDERWENT BILATERAL EXPLANTATION OF BREAST IMPLANTS; BOTH IMPLANTS HAD RUPTURED SHELLS.
PT UNDERWENT BILATERAL BREAST IMPLANT EXPLANTATION. LEFT IMPLANT WAS RUPTURED; RIGHT IMPLANT WAS INTACT.
BILATERAL EXPLANTATION OF BREAST PROSTHESES AND CAPSULECTOMIES. BOTH PROSTHESES WERE INTACT UPON EXPLANTATION.
PT PRESENTED WITH C/O TENDERNESS OF MEDIAL ASPECTS OF BOTH BREASTS FROM BOTH SIDES. ON EXAM, THESE AREAS WERE THICK AND THERE APPEARED TO BE A FIRM CAPSULE, THICKENING OF THE CAPSULE, AND SOME SCAR TISSUE. THERE WAS ALSO A BULGE FROM 6:00 TO 9:00 AREA OF THE L BREAST. PT HAD HAD A BILATERAL MASTECTOMY WITH BILAT RECONSTRUCTION IN 1980. OPEN CAPSULOTOMIES, BILATERALLY WITH REVISION OF SCARS BOTH BREASTS, REPLACEMENT OF IMPLANTS WITH SALINE IMPLANTS. SHE HAD BILATERAL CAPSULAR CONTRACTURE BUT BOTH IMPLANTS WERE INTACT.
PT WAS ADMITTED TO HOSP DUE TO POST-OP WOUND INFECTION. INFECTION TRACED TO WOUND CLOSURE DEVICE. ALL DEVICES WITH SAME LOT NUMBER WERE REMOVED FROM SUPPLY.
PT ADMITTED 10/6/95 AND HAD TISSUE EXPANDER IMPLANTED IN LEFT HIP, SECONDARY TO BURN CONTRACTURE. PT REAMITTED 11/29/95 FOR REMOVAL OF DEFLATED TISSUE EXPANDER AND IMPLANTATION OF SECOND TISSUE EXPANDER IN LEFT HIP.
CIRCULAR STAPLER DID NOT DELIVER KNIFE OR STAPLES ON FIRST FIRING DURING SIGMOID COLON RESECTION ANASTOMOSIS PROCEDURE. ON SECOND FIRING, KNIFE CUT TISSUE PRODUCED DONUT AND STAPLES DELIVERED BUT STAPLES DID NOT CLAMP. CLOSED TO OPEN PROCEDURE.
ROD BROKE WHILE IN PT'S LEG. SURGERY TO REMOVE. MD STATED THIS WAS A STRESS BREAK. ADD'L CAT NUMBER 3517-3010.
ON 9/27/95 AN ANTERIOR CERVICAL PLATE WAS REMOVED FROM THE PT'S CERVICAL REGION BECAUSE IT HAD BROKEN. A NEW PLATE WAS IMPLANTED. THE SECOND PLATE BROKE AT A LATER DATE (DATE UNKNOWN AT THIS TIME).
WHEN BEING INJECTED, DEVICE BROKE LEAVING A PLASTIC PART OF THE BAG IN PT'S ABDOMEN REQUIRING RETRIEVAL OF THE PIECE.
THIS 64 YR OLD WHITE MALE WITH STAGE DILATED CARDIOMYOPATHY WAS ACCEPTED FOR ORTHOTOPIC CARDIAC TRANSPLANTATION. THE PT BECAME INOTROPE AS WELL AS BALLOON PUMP DEPENDENT AND REQUIRED BRIDGE TO TRANSPLANTATION WITH MECHANICAL CIRCULATORY SUPPORT BECAUSE OF INAVAILABILITY OF A SUITABLE DONOR ORGAN. THE PT HAD THE IMPLANTATION PERFORMED ON 4/21/95 AND WAS MAKING A SUITABLE RECOVERY. IT WAS NOTED THAT THE PT HAD BRISK BLEEDING ABOUT THE DRIVE LINE EXIT SITE AND PHYSICAL EXAMINATION INDICATED CONSIDERABLE FLUID ABOUT THE DEVICE ITSELF ON PALPATATION. BECAUSE OF CONTINUAL BLEEDING, OPERATION WAS UNDERTAKEN.
DURING SURGERY THORACOSCOPY WITH BIOPSY OF LEFT LOWER LOBE OF LUNG, THE STAPLER WAS FIRED INTO THE LUNG TISSUE, BUT THEN WOULD NOT UNLOCK AND COULD NOT BE RELEASED WITHOUT MORE DAMAGE TO THE LUNG TISSUE. A THORACOTOMY HAD TO BE PERFORMED TO RELEASE THE STAPLER. THE PROCEDURE WAS VIDEOTAPED. THE CO REP WAS NOTIFIED.
RPTR GAVE SURGEON REPROCESSED, UNUSED STAPLE CARTRIDGE. SURGEON LOADED IT INTO HANDPIECE AND FIRED INSIDE PT. RELOAD JAMMED AND BROKE. PIECES RETRIEVED, THUS LENGTHENED TIME OF SURGICAL PROCEDURE.
PUMP MALFUNCTIONED. PUMP SET AT 50 CC/HR, BUT INFUSED 200 CC IN 20 MINUTES. PUMP STOPPED AND FEEDING WILL BE RESUMED ON NIGHT SHIFT. THERE WAS NO PT INJURY SUSTAINED.
THERE WAS A FRACTURE OF THE SILICONE IMPLANT.
THE IV PHARMACIST DISCOVERED WHAT APPEARS TO BE A HUMAN HAIR INSIDE THE "STERILE" PACKAGING OF THE VALVE ASSEMBLY. THE UNACCEPTABLE PRODUCT WAS FORWARDED TO THE IV CLINICAL MANAGER WHO FILED AN FDA MEDWATCH REPORT THE FOLLOWING DAY.
RUPTURED IMPLANT CAUSED AUTO-IMMUNE DISORDER. PROGNOSIS IS POOR. PT HAS LIFE THREATENING PROBLEM.
PT IN RESPIRATORY FAILURE WAS INTUBATED WITH CUFF INFLATED. NURSE REPLACED FEEDING TUBE AFTER PT HAD REMOVED PREVIOUS TUBE. PORTABLE CHEST X-RAY FOR TUBE PLACEMENT DONE AND DEMONSTRATED TUBE IN LEFT LUNG. PHYSICIAN DEFLATED ET CUFF AND REMOVED FEEDING TUBE. REPEAT CHEST X-RAY SHOWED PNEUMOTHORAX. CHEST TUBE PLACED WITH DIFFICULTY DUE TO OBESITY OF PT. RESUSCITATION UNSUCCESSFUL.
RESIDENT WAS LIFTED WITH A MECHANICAL DEVICE. THE BOLT CAME OUT OF THE HYDRAULIC PORTION OF THE LIFT CAUSING THE PT TO FALL AND LAND ON A BEDSIDE COMMODE. HOSP REPORTED THIS TO THE VENDOR.
A HEPARIN DRIP WAS BEGUN AT 5:30 PM USING AN INFUSION PUMP SET FOR 29 CC/HR. AT 8:00 PM THE DRIP WAS EMPTY WITHOUT AN ALARM SOUNDING. THIS CALCULATED TO MORE THAN 100 CC/HR BEING ADMINISTERED. AN INDEPENDENT BIOMEDICAL ENGINEER EVALUATED THE PUMP ON 12/21/95 AND DETERMINED THAT THE PLATEN HAD PLASTICIZED CREATING A GROOVE WHICH PERMITTED A LEAK IN THE PUMPING MECHANISM. THIS EQUIPMENT WAS A RENTED UNIT.
PT PRESENTED TO PHYSICIAN'S OFFICE WITH A PORT THAT COULD NOT BE FLUSHED. DETACHED PART OF CATHETER WAS REMOVED IN X-RAY UNDER FLUORO. RESERVOIR AND REMAINING CATHETER REMOVED BY SURGEON.
PCA PUMP INFUSION WAS STARTED ON 12/14. ON 12/17 2200 BAG WAS CHANGED AND FLUID REMAINING IN BAG WAS MEASURED TO BE APPROXIMATELY 45 ML AND PUMP HISTORY STATED 7 ML REMAINING. CO WAS CALLED AND CO STATED THAT NO ALARM WILL GO OFF IF TUBING IS OCCLUDED BEFORE PERISTALTIC DEVICE AND PUMP WILL REGISTER AN "ACCURATE" INFUSION.
MD STATES THE FOOTPLATE WAS BENT AND THEREFORE DAMAGED THE DURA WHILE HE WAS ATTEMPTING TO REMOVE THE BONE FLAP.
3-YR-OLD MALE ADMITTED AS OUTPATIENT FOR HEART CATH AND COIL EMBOLIZATION OF PATENT DUCTUS ARTERIOSUS (PDA) BY CARDIOLOGIST. IN CATH LAB, 2 ATTEMPTS TO EMBOLIZE THE PDA RESULTED IN THE COILS MIGRATING TO THE LEFT PULMONARY ARTERY. THESE 2 WERE SNARED SUCCESSFULLY AND REMOVED FROM THE BODY. DURING 3RD ATTEMPT, THE COIL AGAIN MIGRATED TO THE LEFT PULMONARY ARTERY. IT WAS SNARED BUT IN THE ATTEMPT TO REMOVE THE COIL, IT BECAME "STUCK" IN THE DISTAL RIGHT FEMORAL VEIN. SEVERAL ATTEMPTS TO DISLODGE WERE UNSUCCESSFUL. PT TAKEN TO PICU TO AWAIT SURGICAL REMOVAL OF THE COIL (VENOTOMY) FROM RIGHT FEMORAL VEIN, AND SURGICAL CLOSURE OF THE PDA BY CARDIOVASCULAR SURGEON. NO COMPLICATIONS FROM THE SURGERY. PT RECOVERING VERY WELL WITH NO APPARENT SEQUELAE.
CRACK IN NONCONDUCTIVE ANESTHESIA CIRCUIT DISCOVERED AFTER PT'S OXYGEN SATURATION DROPPED DURING OPERATIVE PROCEDURE. PT'S CONDITION STABILIZED AFTER CIRCUIT WAS CHANGED.
PT PRESENTED TO THE EMERGENCY DEPT IN RESPIRATORY DISTRESS. OXYGEN APPLIED VIA NASAL CANNULA WITH NO IMPROVEMENT IN STATUS. UPON INVESTIGATION DEFECT NOTED IN OXYGEN DELIVERY TUBING (PIECE OF TUBING MISSING). WHEN THE TUBING WAS CHANGED, PT'S OXYGENATION IMPROVED.
PT DEVELOPED BILATERAL PNEUMOTHORACES IMMEDIATELY POST-OP TONSILLECTOMY/ADENOIDECTOMY REQUIRING BILATERAL CHEST TUBES AND ADMISSION TO CRITICAL CARE UNIT. CAUSE UNKNOWN. CHECKED BY INTERNAL/EXTERNAL SOURCES AND NO PROBLEMS FOUND.
ENDOSCOPIC RELOADABLE LINEAR CUTTER MALFUNCTIONED AFTER THIRD RELOAD AND WOULD NOT OPEN BACK UP.
PT COMPLAINED OF LEFT SHOULDER PAIN AND NON-FUNCTIONING LEFT SUBCLAVIAN VEIN PORT NOT FUNCTIONING APPROPRIATELY. FISTULOGRAM SHOWED CATHETER HAD HOLE IN IT AS IT WENT BENEATH THE CLAVICLE AND EXTRAVASATED FLUID. PORT WAS REMOVED IN SURGERY AND REPLACED.
ECTOPIC PREGNANCY. AFTER INSERTION OF TROCAR, OBTURATOR DID NOT RETRACT. THIS RESULTED IN SCRAPING AND LACERATION OF BOWEL IN TWO PLACES. (PUNCTURE) TROCAR WENT IN SMOOTH AND WITHOUT INCIDENT. PHYSICIAN THEN STATED ON 2ND INSERTION TROCAR HARD TO GET IN AND AT THAT MOMENT TROCAR LET GO. ANOTHER SURGEON CALLED IN FOR CONSULTATION AND REPAIR OF SCLEROSAL TEAR.
LAPAROSCOPIC HIATAL HERNIA REPAIR. DURING PROCEDURE SURGEON INSERTED DISPOSABLE SUTURE INTO GASTRIC WALL. WHEN OPENING DEVICE SUTURE NEEDLE STAYED IN GASTRIC WALL. AS SURGEON REMOVED NEEDLE TRANSFER DEVICE HE REALIZED NEEDLE WAS MISSING. SUTURE BROKE OFF NEEDLE, BUT WHAT WAS LEFT OF SUTURE WAS RETRIEVEABLE. IMMEDIATE ACTION: FLUOROSCOPY FOR DETECTION. EXPLORATORY LAPAROTOMY PERFORMED. SUTURE NEEDLE COULD NOT BE LOCATED OR RETRIEVED. DR CLOSED INSCISION.
PT IN SURGERY FOR LOWER EXTREMITY VASCULAR SURGERY. ON HYPERTHERMIA BLANKET WITH GEL PAD AND SHEETS NEXT TO PT. FOLLOWING SURGERY, BURN APPROX 14 CM BY 10 CM ON RIGHT BUTTOCKS WAS NOTED. HYPOTHERMIA SET TO WARM TO 38/100, AT THE END OF THE CASE THE TEMP READ 130 DEGREES, THE PAD TEMPERATURE WARNING LIGHT DIDN'T COME ON AND MACHINE DIDN'T SHUT OFF AT DESIRED TEMPERATURE.
HEARD A POP WHILE LIFTING. TENDERNESS, PAIN AND CHANGE IN SHAPE OF RIGHT BREAST. PT HAS SIGNIFICANT CAPSULE FORMATION BILATERALLY, FIBROSIS, HYPOPLASIA. PT NOW HAVING BILATERAL REPLACE. BOTH IMPLANTS WERE INTACT.
A PT WITH PULMONARY FIBROSIS WHO HAD BEEN RECEIVING OXYGEN BY MASK WAS TRANSPORTED FOR DIAGNOSTIC TESTING ON LIQUID OXYGEN INSTEAD OF COMPRESSED OXYGEN. HE RETURNED TO HIS ROOM UNRESPONSIVE AND WITH AGONAL RESPIRATIONS. HE WAS RESUSCITATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT.
MECHANICAL PROBLEMS DUE TO BREAST IMPLANTS. BREAST IMPLANT CAPSULE IS REPORTED TO LEAK.
PT HAD TOTAL HIP REPLACEMENT ON 3/23/88 WITH PRODUCT. PT EXPERIENCED PAIN IN HIPS AND IT WAS DISCOVERED THAT THE POLY ACETABULAR LINER HAD FAILED. UPON REMOVAL THE LINER WAS IN SEVERAL PIECES.
PT HAD A TOTAL HIP REPLACEMENT WITH PRODUCT ON 12/9/87. PT EXPERIENCED PAIN IN HIP AND IT WAS DISCOVERED THAT THE POLY ACETABULAR LINER HAD FAILED - LINER FRACTURED INTO SEVERAL PIECES.
IN 1981 PT HAD BILATERAL BREAST AUGMENTATION. PT PRESENTED TO DR AFTER 14 YEARS WITHOUT FOLLOW-UP WITH BILATERAL GRADE II AND III CAPSULAR CONTRACTURE AND ANXIETY RELATING TO SILICONE IMPLANTS. BILATERAL OPEN CAPSULOTOMY WITH REPLACEMENT OF SILICONE IMPLANTS WITH SALINE IMPLANTS.
RN INSERTED PIC LINE (3.0) WITHOUT DIFFICULTY. IN REMOVING THE GUIDE WIRE THROUGH THE INJECTION PORT ON THE EXTENSION TUBING, THE SOLID CORE WIRE BROKE AND THE TEFLON COATED SPRING WIRE CONTINUED TO PULL OUT. THE RN UNSCREWED THE EXTENSION TUBE FROM THE CATHETER AND REMOVED THE GUIDE WIRE WITHOUT DIFFICULTY. THE BROKEN WIRE WITH THE SPRING WIRE ATTACHED WAS SENT TO CO.
AORTIC VALVE EXPLANTED ON 12/5/95 FOR ENDOCARDITIS.
C-ARM USED FOR PT IN ICU. WHEN MOVING C-ARM OUT OF ROOM FRONT WHEEL BOLT SNAPPED OFF. NO ONE INJURED. UNIT REMOVED AND WILL NOT BE PUT BACK INTO SVC AT THIS TIME.
PT HAD A BILATERAL BREAST AUGMENTATION IN 1973 WITH SILICONE GEL IMPLANTS. SHE DEVELOPED BILATERAL ENCAPSULATIONS. SHE HAD THE GEL IMPLANTS REMOVED ON 8/9/95 AND REPLACED WITH SALINE INFLATABLE IMPLANTS. PT NOW HAS DEVELOPED A CAPSULAR CONTRACTURE ON THE RIGHT SIDE. A RIGHT OPEN CAPSULOTOMY/CAPSULORRHAPHY IS NEEDED.
THE DIALYSIS MACHINE REMOVED 10 POUNDS OF FLUID IN TWO HRS RATHER THAN 9 POUNDS IN FOUR HOURS AS WAS PROGRAMMED. NO ALARM INDICATORS LIT AND AUTOTEST WAS NEGATIVE, ALSO WATER LEAKED. BIOMED DISCOVERED THE PRV3 DIAPHRAGM WAS TORN. THE PT FELT "FUNNY," WAS DIZZY AND PALE, SHE REQUIRED NORMAL SALINE SOLUTION INFUSION OF 200 CC.
PT STATUS POST INTRATHECAL PUMP INSERTION 10/28/95 FOR DELIVERY OF CONTINUOUS NARCOTICS. PT EXHIBITING SIGNS AND SYMPTOMS OF NARCOTIC WITHDRAWAL. PT ADMITTED TO HOSP TO CONTROL WITHDRAWAL SYMPTOMS AND PAIN WITH MEDICATION.
MD STATES CHILD ADMITTED WITH SHUNT TUBING FRACTURE JUST BELOW VALVE. DISTAL END WAS RETRIEVED FROM ABDOMEN AND NEW VALVE/PERITONEAL CATHETER PLACED.
MD REPORTED VERBALLY THAT PT'S SHUNT HAD "FRACTURED," REQUIRING SURGICAL REVISION ON 11/3/95. MD GAVE IMPLANT TO SALES REP ON 11/9/95.
MD REPORTED VERBALLY THAT PT'S SHUNT HAD "FRACTURED," REQUIRING SURGICAL REVISION ON 11/7/95. IMPLANT DISCARDED (NO MD REQUEST TO HOLD).
ARRIVED IN OR WITH COMPLAINT OF PENILE PROSTHESIS THAT WILL NOT HOLD ERECTILE PRESSURE.
RPTR TRIED TO USE TWO PICC LINES AND THEY BOTH HAD HOLES IN THEM WHEN TAKEN OUT OF PACKAGING. DEFECT IN TUBING.
TOURNIQUET PLACED ON PT'S LEFT ARM SETTING PROGRAMMED IN DEVICE NOT ACTIVATED AT END OF SURGERY, TOURNIQUET WAS INFLATED READING 01 PRESSURE TIME OVER 800 MINUTES. EQUIPMENT WILL BE SHIPPED TO AN INDEPENDENT TESTING ORGANIZATION FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FORWARDED UPON RECEIPT OF FINDINGS FROM THE ORGANIZATION.
BALLOON INSERTED INTO RCA. DURING INITIAL INFLATION, BALLOON WOULD NOT HOLD PRESSURE. THE ENTIRE CATHETER WAS REMOVED FROM BODY. IT WAS NOTED THAT THE CATHETER HAD SEPARATED LINER MID SECTION. CATHETER WAS BAGGED IN PACKAGE AND DATED.
CORONARY STENT DID NOT COMPLETELY INFLATE DURING USE FOLLOWING CORONARY DISSECTION ROTATIONAL ATHRECTOMY. PARTICALLY INFLATED STENT LEFT IN CORONARY ARTERY. PT REQUIRED OPENHEART SURGERY TO REMOVE STENT.
ON 10/20/95 AN ANASTOMOTIC LEAK WAS RECOGNIZED; PT TAKEN TO OR EMERGENTLY. INTRAOPERATIVELY FOUND DISRUPTION OF STAPLE LINE.
WHILE PERFORMING SURGERY, PHYSICIAN WAS HAMMERING WITH A METAL HAMMER ON A METAL IMPACTOR USED FOR JOINT PROSTHESIS. A METAL SLIVER FLEW OFF, STRIKING PHYSICIAN IN THE LEFT SHOULDER AND LODGING THERE. X-RAY WAS DONE SHOWING THAT IT WAS INDEED IMBEDDED IN PHYSICIAN'S LEFT SHOULDER.
DEVICE INSERTED AT 2130 1/3 FOR CERVICAL RIPENING INDUCTION OF LABOR ON TERM PREGNANCY. APPROX 3 HOURS LATER, PT GOT UP TO BATHROOM AND DEVICE STRING CAME OUT BUT PROSTAGLANDIN IMPREGNATED STRIP DID NOT. PT CONTINUED THROUGH VERY RAPID, UNCONTROLLED LABOR AND DELIVERY DUE TO INABILITY TO REMOVE DEVICE. PRODUCT WAS KEPT IN FREEZER AS REQUIRED.
A #7 FRENCH VASCULAR SHEATH WAS INSERTED INTO THE COMMON FEMORAL ARTERY. THROUGH THE #7 FRENCH SHEATH, AN 8 MM X 3 CM LONG VASCULAR STENT WAS PLACED. THE SHEATH WAS THEN WITHDRAWN. THE BALLOON WAS THEN INFLATED. THE STENT WAS DEPLOYED. FOLLOW-UP ARTERIOGRAM SHOWS SLIGHT IRREGULARITY PROXIMAL TO THIS LESION. THEREFORE, A SECOND STENT WAS TO BE PLACED. THROUGH THE SAME VASCULAR SHEATH, A SECOND 8 MM X 3 CM STENT WAS THEN INSERTED. THE STENT WAS PLACED IN THE APPROPRIATE POSITION. THE SHEATH WAS THEN WITHDRAWN. THE ANGIOPLASTY BALLOON WAS THEN STARTED TO INFLATE USING THE INFLATOR; HOWEVER, THE BALLOON RUPTURED LONG BEFORE THE RECOMMENDED ATMOSPHERIC PRESSURE WAS REACHED WHICH WAS 6.5. THE BALLOON RUPTURED JUST AT THE START OF INFLATING THE ANGIOPLASTY BALLOON. THE STENT WAS ONLY PARTIALLY DISTENDED AND HAD AN HOURGLASS APPEARANCE WITH THE PROXIMAL AS WELL AS DISTAL END FLARED. THE STENT COULD NOT BE RETRIEVED AT THIS POINT INTO THE VASCULAR SHEATH. THEREFORE, WITH MULTIPLE AND EXTENSIVE MANIPULATION, THE RUPTURED ANGIOPLASTY BALLOON AND A SECOND ANGIOPLASTY BALLOON CATHETER WERE THEN INSERTED THROUGH THE VASCULAR SHEATH AND PLACED IN THE APPROPRIATE POSITION FOR THE STENT. HOWEVER, THE STENT NOW WAS OVER THE VASCULAR SHEATH AND THE STENT COULD NOT BE SATISFACTORILY DEPLOYED. THE STENT WAS ADVANCED PAST THE INITIAL STENT TO A MORE PROXIMAL ASPECT AND THE SLIGHTLY FLARED LEGS WERE THEN GENTLY APPROXIMATED TO THE OTHER STENT, AND AT THIS POINT THE VASCULAR SHEATH COULD BE WITHDRAWN OUT OF THE STENT. THE BALLOON WAS THEN INFLATED. HOWEVER, THE POSITIONING WAS SUBOPTIMAL AND IT SEPARATED FROM THE FIRST STENT BY APPROXIMATELY 2-3 MM IN LENGTH. FOLLOWING THE DEPLOYMENT OF THIS STENT, ANGIOGRAM WAS THEN PERFORMED. AFTER THE EXTENSIVE MANIPULATION IN RETRIEVING THE STENT FOLLOWING EQUIPMENT FAILURE, THERE WAS THROMBOSIS NOTED WITHIN THE RIGHT ILIAC ARTERY EXTENDING DOWN INTO THE RIGHT COMMON FEMORAL ARTERY. AT THIS POINT, THE ONLY CHOICE OF FURTHER THERAPY WOULD BE UROKINASE. UROKINASE WAS THEN STARTED FOLLOWING A HAND INJECTION AND INFUSION OF 100,000 U FOLLOWED UP BY 100,000 U FOR SEVERAL HOURS. SURGERY WAS GREATLY PROLONGED. (*)
PT HAD BILATERAL TOTAL KNEE REPLACEMENT UNCERTAIN AS TO DATE. IN 1990 LEFT TOTAL KNEE WAS NOTED TO HAVE BREAKING OF THE POLYETHYLENE AND TIBIAL LINING. PT WAS FOLLOWED CONSERVATIVELY DUE TO HIS AORTIC STENOSIS UNTIL HE WAS UNABLE TO WALK ON IT, WHICH SUBSEQUENTLY RESULTED IN A TOTAL KNEE REVISION.
PT HAD DISPLACED FRACTURE OF RIGHT FEMORAL NECK. IN OR FOR BIPOLAR ARTHROPLASTY. DURING THE PROCEDURE, AFTER THE CANAL HAD BEEN PREPARED AND LAVAGED, THE CEMENT WAS INSERTED. THE PT BEGAN TO HAVE BRADYCARDIA. DESPITE ATTEMPTS AT RESUSCITATION WITH LIDOCAINE AND ATROPINE, PT EXPIRED 42 MINUTES LATER FROM PROGRESSING BRADYCARDIA AND HYPOXIA LEADING TO CARDIOPULMONARY ARREST. ANESTHESIA USED WAS MARCAINE SPINAL 15 MG INSERTED AT L3-4.
PT TAKEN TO OR FOR UNIPOLAR HEMI-ARTHROPLASTY OF LEFT FEMUR. AFTER INSERTION OF CEMENT TO THE POINT OF THE PROSTHESIS, THE PT BECAME HYPOTENSIVE AND BRADYCARDIAC. ADVANCED LIFE SUPPORT MEASURES WERE ATTEMPTED FOR 20 MINUTES, BUT THE PT EXPIRED.
SURGEON NOTIFIED RPTR THAT PT HAD BEEN TO HIS OFFICE WHERE A 1" X 1/2" PIECE OF FOAM WAS RETRIEVED FROM THE VAGINA. PT HAD UNDERGONE AN ABDOMINAL HYSTERECTOMY ON 11/13/95 AND HAD PREP DONE IN SURGERY PRIOR TO THE PROCEDURE WITH THE DEVICE. THE FOAM IS APPARENTLY THE REMNANTS OF THE PREP WAND FOUND IN THIS PREP TRAY.
RPTR STATES A SMALL HOLE IN THE TUBING OF THE BUTTERFLY CAUSED BLOOD TO POUR OUT ONTO THE TABLE. RPTR HAD TO RESTICK THE PT IN ORDER TO GET A BLOOD SAMPLE. (*)
PT WAS IN CARDIAC CATHETER LAB FOR A PROCEDURE. THE CARDIAC CATHETER BROKE OFF IN THE AORTA AND THE PT HAD TO GO TO THE OR FOR IT TO BE RETRIEVED.
PT CLAIMS PERMANENT VISION LOSS DUE TO TARGETING LASER IN CT SCAN UNIT.
VENTILATOR CONNECTED TO PT BEGAN TO SMELL OF BURNING PLASTIC AND BEGAN TO OMIT SMOKE. THE SCREEN WENT BLACK BUT THE VENTILATOR CONTINUED TO FUNCTION UNTIL IT WAS DISCONNECTED FROM THE PT AND TAKEN OUT OF SERVICE. NO INJURY.
PT'S CHEST AREA RECEIVED 1ST DEGREE BURNS DURING CARDIOVERSION USING THE PADS.
RPTR HAD AUGMENTATION MAMMOPLASTY PERFORMED IN APRIL 1979 WITH THE UNDERSTANDING THAT THE IMPLANTS WOULD LAST FOREVER UNLESS SHE WAS IN A MAJOR ACCIDENT WITH CHEST TRAUMA, GUNSHOT TO THE CHEST, OR STABBING. NONE OF THIS OCCURRED. RPTR NOTICED LUMP IN RIGHT BREAST. MAMMOGRAM SHOWED POSSIBLE LEAK. SURGERY WAS PERFORMED 4/86, LEAK WAS EVIDENT. "QUADRECTOMY" PERFORMED. SOME GEL IS STILL IN RPTR'S RIGHT BREAST. SYSTEMIC DERMATITIS '87 AND '89 FOOT PAIN AND BURNING 1988, LEG PAIN, 3 SURGERIES 1992, NOW DISABLED, HAS MULTIPLE NEUROPATHY AND CONNECTIVE TISSUE DISEASE 1992.
IN 1984 RPTR HAD BREAST RECONSTRUCTION FOLLOWING BREAST CANCER SURGERY IN 1983. SHE HAD A PROPHYLACTIC MASTECTOMY ALSO. THEREFORE SHE HAD 2 SILICONE IMPLANTS PUT IN. SIX WEEKS LATER SHE HAD TO HAVE ONE REPLACED DUE TO SEVERE CAPSULAR CONTRACTURE. DURING THE NEXT 8 YEARS, SHE LIVED WITH HER IMPLANTS. SHE FORMED CAPSULES AROUND THEM. THEY HURT AND ITCHED. IN 1992 SHE DISCOVERED THROUGH MRI THAT THEY WERE RUPTURED. SHE FINALLY HAD SURGERY TO REMOVE THEM 2/16/95. (ALSO SEE 1008129)
IN 1984 RPTR HAD BREAST RECONSTRUCTION FOLLOWING BREAST CANCER SURGERY IN 1983. SHE HAD A PROPHYLACTIC MASTECTOMY ALSO. THEREFORE SHE HAD 2 SILICONE IMPLANTS PUT IN. SIX WEEKS LATER SHE HAD TO HAVE ONE REPLACED DUE TO SEVERE CAPSULAR CONTRACTURE. DURING THE NEXT 8 YEARS SHE LIVED WITH HER IMPLANTS. SHE FORMED CAPSULES AROUND THEM. THEY HURT AND ITCHED. IN 1992 SHE DISCOVERED THROUGH MRI THEY WERE RUPTURED. SHE FINALLY HAD SURGERY TO REMOVE THEM 2/16/95. (ALSO SEE 1008128)
DUE TO THE RUBBER SEAL USED IN THE SPECIMEN BOTTLES SUPPLIED BY THE CONTRACTOR, THESE BOTTLES CANNOT BE USED FOR DRUG TESTING. THE RUBBER SEAL INSIDE THE LID ABSORBS THE THC FROM THE URINE SPECIMEN THAT ARE SUBMITTED TO THE LABS FOR TESTING. SINCE THC IS THE MOST COMMON ILLEGAL DRUG THAT IS WIDELY USED, THIS WILL RENDER THE DRUG TEST INEFFECTIVE IN THIS AREA AND SERIOUSLY HINDER THE EFFECTIVENESS OF THE PROGRAM TO ASSIST IN COMBATTING DRUG USAGE.
LANCASTER CO ASSOC FOR THE BLIND, 244 NORTH QUEEN ST, LANCASTER, PA 17603. CORRECTIVE ACTION TAKEN, MASKS REPLACED. DEFECT WOULD NOT CAUSE DEATHS OR SERIOUS INJURIES.
OPEN CHOLECYSTECTOMY PERFORMED ON 11/27/95. TWO CLIPS WERE PLACED DISTAL TO THE BIFURCATION OF THE CYSTIC DUCT. ON 12/5/95, THE PT WAS TAKEN BACK TO SURGERY WHERE 3900 CC OF INTERSTITIAL BILOUS DRAINAGE WAS DRAINED. AUTO AMPUTATED CYSTIC DUCT WITH INABILITY TO FIND THE CLIP ON CYSTIC DUCT PORTION WERE NOTED. THE FLUID LEAKAGE WAS FROM THIS SITE. CO WAS NOTIFIED ON 12/15/95 AND AFTER DISCUSSION IT WAS DETERMINED THAT THIS EVENT SHOULD BE REPORTED AS POSSIBLE CAUSE FOR THE ABOVE EVENT.
PT UNDERWENT AN ATTEMPTED LEFT ILIAC ANGIOPLASTY. PREVIOUSLY THE PT HAD STENTS AND A CATHETER, NINE FRENCH SHEATH WAS PASSED BEYOND THE STENT. UPON REMOVING THE SHEATH RESISTANCE WAS MET, THE CATHETER MANIPULATED AND AFTER REMOVING IT, THE END WAS RAGGED SUGGESTING THAT IT HAD TORN ON THE INDWELLING VASCULAR STENT WITH SEVERAL CENTIMETERS OF THE END OF THE SHEATH MISSING. FURTHER ANGIOGRAPHY WAS PERFORMED AND A CATHETER USED TO TRY AND FIND THE SHEATH BUT TO NO AVAIL. DUE TO THE PHYSICIAN'S CONCERN THAT THE SHEATH REMNANT COULD LEAD TO THROMBOSIS OF THE RIGHT INTERNAL ILIAC ARTERY, HE ELECTED TO PROCEED WITH A LEFT INTERNAL ILIAC ARTERY ENDARTERECTOMY TO ASSURE ADEQUATE PELVIC BLOOD FLOW. THIS WAS ACCOMPLISHED WITHOUT DIFFICULTY.
PT WAS SITTING IN THE GERIATRIC CHAIR AND WAS BANGING THE TRAY TABLE BACK AND FORTH AGAINST THE ARMS OF THE CHAIR. STAFF NOTICED BLOOD AND THAT 1/2 INCH OF THE TIP OF HER RIGHT "PINKIE" WAS MISSING. THE TIP OF THE FINGER WAS FOUND UNDER THE GERIATRIC CHAIR. DUE TO THE PT'S AGITATION AND PSYCHIATRIC PROBLEMS, SHE WAS NOT ABLE TO RELATE WHAT HAPPENED. EVALUATION OF THE GERIATRIC CHAIR BY THE SAFETY OFFICER REVEALED THE PT PROBLABLY CAUGHT HER FINGER BETWEEN THE TRAY AND THE ARMREST. THE TRAY WAS STILL IN ITS TRACK, BUT WAS PULLED TO THE LEFT. A LOCK BRACKET WAS IN PLACE ON THE CHAIR BUT NONE OF THE HOLES HAD A SHARP EDGE.
ON 12/24 IT WAS NOTICED THAT THERE WAS BLOOD WITHIN THE INTRA-AORTIC BALLOON PUMP TUBING AND THE BALLOON WAS NOT FUNCTIONING. THERE WAS A LARGE INSPISSATED PLUG WITHIN THE BALLOON WHICH INITIALLY MADE IT IMPOSSIBLE TO REMOVE THE BALLOON FROM THE FEMORAL PUNCTURE. AFTER DISSOLUTION WITH STREPTOKINASE, THE BALLOON WAS EASILY REMOVED.
THE AC POWER CORD AT THE EQUIPMENT INLET HAD BEEN PARTIALLY PULLED OUT. THIS CONDITION CAUSED ARCING BETWEEN AC POWER CORD AND CONTACT POLES OF THE ELECTRICAL INLET. THE RESULT OF THE ARCING WAS BURNING OF THE AC POWER CORD COVERING WHICH PRODUCED BLACK PUNGANT SMOKE. THE DEVICE HAD BEEN IN USE FOR 14 MONTHS AND WAS LAST SERVICED ON 10/13/95. OTHER UNITS OF THE SAME MODEL ARE SIMILARLY AFFECTED. THERE WAS NO INJURY.
OPERATOR STATED UNIT GETS HOT. UNITS WERE PULLED FROM SERVICE AND WHEN INSPECTED, BURNS WERE NOTED ALONG THE POWER CORDS. RPTR CONTACTED THE MFR, AND THE SENIOR SERVICE REPRESENTATIVE PROVIDED NEW CORDS BUT DID NOT INSTALL THEM. RPTR SUBMITTED A REPORT TO THE FDA APPROX 3 TO 4 YEARS AGO ON AN OLDER PRODUCT WITH THE SAME DESIGN PROBLEMS. RPTR DOES NOT WANT TO REPLACE CORDS BECAUSE THIS WILL NOT CORRECT THE PROBLEM.
PT HAD FLUSHING, HYPERTENSION, TIGHTNESS OF CHEST AND RASH OVER NECK AND ARM. PT WAS TREATED WITH 1000 CC OF IV FLUID AND RECOVERED. FACILITY IS NO LONGER USING THIS DEVICE BECAUSE OF PAST EXPERIENCES.
IMMEDIATELY AFTER THE CATHETER WAS ADVANCED (WITHIN 15 SECONDS) THE PT EXPERIENCED FLUSHING, SHORTNESS OF BREATH AND TACHYCARDIA. THE PT STATED THE "TOP OF HER HEAD WAS GOING TO COME OFF." FACILITY FEELS THAT SOMETHING WAS TERRIBLY WRONG. PT GOT A RASH ON HER FACE, NECK, AND ARMS WHERE THE CATHETER WAS INSERTED, THE RASH TOOK A WEEK TO 10 DAYS TO RESOLVE COMPLETELY. FACILITY IS NO LONGER USING THIS DEVICE BECAUSE OF PAST EXPERIENCES.
SIEMENS MEDICAL SYSTEMS, INC. 4040 NELSON AVE, CONCORD, CA 94520. THE REPORT STATES THAT A LOWER THAN DESIRED DOSE WAS DISPLAYED AT THE ACCELERATOR CONSOLE, AND ALSO AT THE LANTIS RECORD AND VERIFY SYSTEM PRIOR TO THE START OF TREATMENT. THE INCORRECT VALUE WAS NOTICED AND REJECTED BY THE OPERATOR, WHO THEN REENTERED THE FIELD. THE CORRECT VALUE THEN APPEARED. IT IS THE PRIMARY FUNCTION OF RECORD AND VERIFICATION SYSTEMS SUCH AS LANTIS TO COMPARE TREATMENT PARAMETERS AS THEY APPEAR ON THE TREATMENT SCREEN, AGAINST THE TREATMENT PRESCRIPTION AS PROGRAMMED INTO THE LANTIS PT DATASBASE. IF DISPLAYED VALUED DO NOT AGREE WITH PRESCRIBED VALUES, TREATMENT MAY NOT PROCEED UNLESS DELIBERATE OVERRIDE PROCEDURES ARE INITIATED. A THOROUGH SYSTEM INSPECTION WAS PERFORMED AT THE USER'S SITE TO DETERMINE THE CAUSE OF THE REPORTED LOW PRESET DOSE INDICATION. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED BY SVC PERSONNEL. AS A PRECAUTION, A CIRCUIT BOARD WHICH COULD CAUSE SUCH A SYMPTOM, WHERE IT COULD MALFUNCTION, WAS REPLACED. SINCE THAT TIME, THE SYMPTOM HAS NOT RECURRED.
DURING LAPAROSCOPIC CHOLECYSTECTOMY, ONE SIDE OF THE PINCER MECHANISM OF THE GRASPER BROKE OFF AND FELL INTO THE ABDOMINAL CAVITY. THE SURGEON WAS NOT ABLE TO LOCATE THE PIECE WITHOUT OPENING THE ABDOMEN WHICH WAS CONSIDERED TO BE TOO HIGH A RISK DUE TO THE PT'S CORONARY DISEASE.
PT HAD INSERTION OF A TWO-LUMEN SUBCLAVIAN CATHETER BY EXPERIENCED OPERATOR (MD), AND DUE TO LARGE RIGHT BREAST PT WAS IN TRENDELENBERG POSITION. THE .035" (89 MM) DIA X 23-5/8" (60 CM) SPRING-WIRE GUIDE BECAME DEFORMED AND DOCTOR WAS UNABLE TO REMOVE IT THROUGH THE 18GA X 2 1/2" (6.25 CM) CATHETER ASSEMBLY. WHEN ALL WAS REMOVED, THE SPRING-WIRE J-GUIDE SEPARATED, REMAINING UNDER THE SKIN, RIGHT CLAVICLE, INTO THE SUBCLAVIAN VEIN, DOWN INTO THE VENA CAVA. THIS WAS VERIFIED BY POST-PROCEDURE X-RAY FOLLOWING A SECOND IMMEDIATELY-PLACED CENTRAL LINE USING AN IDENTICAL KIT, WITH A NURSE APPLYING CAUDAD TRACTION ON THE LARGE BREAST TO PREVENT DEFORMITY OF THE CATHETER & J GUIDE WIRE DURING THE PROCEDURE. SECOND INSERTION WAS WITHOUT INCIDENT AND J SPRING-WIRE WAS EASILY WITHDRAWN. INTERVENTIONAL RADIOLOGIST REMOVED SPRING WIRE REMNANT PROMPTLY VIA RIGHT FEMORAL VEIN APPROACH WITHIN 8 HOURS.
WHEN DEFIBRILLATOR CONNECTED IN CRITICAL CARE UNIT, IT STATED "PACING ELECTRODE OFF". ALL CONNECTIONS RE-SECURED AND IT STILL DID NOT WORK. WHEN PACING CABLE WAS TAKEN FROM THE DEFIBRILLATOR AND PLACED ON ANOTHER MODEL, PACING WAS ABLE TO BE ACCOMPLISHED. BIOMED FUNCTION CHECK ON THE DEFIBRILLATOR COULD NOT REPRODUCE PROBLEM.
EVALUATION FINDINGS: THIS BOWL WAS RETURNED FOR EVALUATION. CO WAS NOT ABLE TO REPLICATE THE NOISE OR THE LEAK REPORTED. CO DID FIND ABRASION SIGNS ON THE RIBS OF THE HEADER AND THE EFFLUENT TUBE, INDICATING THAT THE BOWL WAS NOT SEATED PROPERLY. THIS COULD HAVE CAUSED THE NOISE AND THE LEAK.
DURING CARDIAC CATHETERIZATION MANIFOLD CRACKED. AIR NOTED IN LINE. IMMEDIATE ACTIONS PREVENTED AIR EMBOLI. MANIFOLD WAS CHANGED AND THE CASE PROCEEDED WITHOUT FURTHER INCIDENT. RPTR HAS EXPERIENCED SIMILAR INCIDENTS WITH OTHER PTS SINCE 12/95.
RETAINED SUTURE, PERINEUM. 3-0 CHROMIC GUT SUTURES USED FOR EPISIOTOMY AFTER DELIVERY ON 8/10/95. SUTURES SHOULD HAVE ABSORBED BUT DID NOT. ON 1/12/96, RETAINED SUTURES AND SCAR TISSUE REMOVED SURGICALLY AND SENT FOR PATHOLOGY EXAM.
PICC LINE INSERTED. A SMALL "PIN" HOLE WAS NOTED AT THE DISTAL END OF PICC. AN ATTEMPT WAS MADE TO PATCH/TAPE DEVICE NOT USED BUT LEAKAGE CONTINUED. PICC LINE WAS DISCONTINUED THE NEXT DAY DUE TO LEAKAGE. ON 11/6/95 PORT WHICH WAS LEAKING WAS CLAMPED OFF, AND DOUBLE LUMEN WAS CONNECTED TO PICC FOR DELIVERY OF TPN AND MEDICATIONS. PICC HAD GOOD BLOOD RETURN AND WAS RUNNING VIA IV PUMP WITHOUT LEAKAGE WHILE DISTAL PORT WAS CLAMPED OFF. (*)
VALVE IS DEFECTIVE; WILL NOT OPEN OR CLOSE.
RPTR HAD BREAST IMPLANTS REPLACED THREE TIMES AND HAD 4 BREAST SURGERIES INCLUDING THE FIRST IMPLANT SURGERY. RPTR C/O BLOOD PRESSURE PROBLEMS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, BILATERAL CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, BEGINNING ORGANIC BRAIN SYNDROME, ELEVATED CHOLESTEROL OR TRIGLICERIDES, CHRONIC PAIN AND DISCOLORATION OF EXTREMITIES (RED OR BLUE), HEAT OR COLD SENSITIVITY, RAYNAUD'S DISEASE, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA AND/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, HYSTERECTOMY, FREQUENT MIGRAINES/SEVERE HEADACHES (SINUS), HYPERSENSITIVITY OR ALLERGIES TO: CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, JOINTS INFLAMMATION, SWELLING, PAIN/ARTHRALGIA AND RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, UNEXPLAINED SKIN RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, CHRONIC INSOMNIA, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPS THINGS AND MISJUDGES DISTANCE/RUNS INTO OBJECTS. RPTR HAD NUMBNESS IN THE SURGICAL AREA, HAD 2 CAPSULAR CONTRACTURES AND 12 CLOSED AND ONE OPEN CAPSULOTOMY. (*) (ALSO SEE 1008145, 1008146)
RPTR HAD BREAST IMPLANTS REPLACED THREE TIMES AND HAD 4 BREAST SURGERIES INCLUDING THE FIRST IMPLANT SURGERY. RPTR C/O BLOOD PRESSURE PROBLEMS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, BILATERAL CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, BEGINNING ORGANIC BRAIN SYNDROME, ELEVATED CHOLESTEROL OR TRIGLICERIDES CHRONIC PAIN AND DISCOLORATION OF EXTREMITIES (RED OR BLUE), HEAT OR COLD SENSITIVITY, RAYNAUD'S DISEASE, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA AND/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, HYSTERECTOMY, FREQUENT MIGRAINES/SEVERE HEADACHES (SINUS), HYPERSENSITIVITY OR ALLERGIES TO: CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, JOINTS INFLAMMATION, SWELLING, PAIN/ARTHRALGIA AND RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, UNEXPLAINED SKIN RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, CHRONIC INSOMNIA, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPS THINGS AND MISJUDGES DISTANCE/RUNS INTO OBJECTS. RPTR HAD A HEMATOMA AND NUMBNESS (NIPPLE OR BREAST) IN THE SURGICAL AREA, SHE HAD A CAPSULAR CONTRACTURE AND ONE OPEN CAPSULOTOMY. (*) (ALSO SEE 1008144, 1008146)
RPTR HAD BREAST IMPLANTS REPLACED THREE TIMES AND HAD 4 BREAST SURGERIES INCLUDING THE FIRST IMPLANT SURGERY. RPTR C/O BLOOD PRESSURE PROBLEMS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, BILATERAL CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, BEGINNING ORGANIC BRAIN SYNDROME, ELEVATED CHOLESTEROL OR TRIGLICERIDES CHRONIC PAIN AND DISCOLORATION OF EXTREMITIES (RED OR BLUE), HEAT OR COLD SENSITIVITY, RAYNAUD'S DISEASE, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA AND/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, HYSTERECTOMY, FREQUENT MIGRAINES/SEVERE HEADACHES (SINUS), HYPERSENSITIVITY OR ALLERGIES TO: CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, JOINTS INFLAMMATION, SWELLING, PAIN/ARTHRALGIA AND RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, UNEXPLAINED SKIN RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, CHRONIC INSOMNIA, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPS THINGS AND MISJUDGES DISTANCE/RUNS INTO OBJECTS. RPTR HAD AN INFECTION AND NUMBNESS (NIPPLE OR BREAST) IN THE SURGICAL AREA, SHE HAD BLEEDING THROUGH THE ENVELOPE. THERE WAS NO POLYURETHANE IN THE IMPLANT AFTER EXPLANTED. SHE HAD ONE OPEN CAPSULOTOMY. (*) (ALSO SEE 1008144, 1008145)
DENTAL IMPLANT FAILED TO OSSEOINTEGRATE.
THE PT HAD REVISION SURGERY ON 3/8/95 BECAUSE OF CONTINUED PAIN AND AT THE TIME OF REVISION PT WAS FOUND TO HAVE PREMATURE WEAR OF COMPONENTS.
BAGS ARE NOT DRAINING AND URINE IS BACKING UP INTO THE PT'S BLADDER. PT DEVELOPED AN INFECTION AND WAS TREATED WITH ANTIBIOTICS.
BAGS ARE NOT DRAINING AND URINE FLOWS BACK INTO THE PT'S BLADDER. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT.
BAGS ARE NOT DRAINING AND URINE IS BACKING INTO TUBING. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT.
WHILE THE NURSE WAS CLEANING A DEEP WOUND, THE COTTON TIP APPLICATOR BROKE AND TWO PIECES FELL INTO THE WOUND. THE PT HAD TO BE TAKEN TO THE ER WHERE THE TWO PIECES WERE RETRIEVED.
THE DISTAL 1/3 OF THE STEM FRACTURED. STEM WAS IMPLANTED APPROXIMATELY 18 MONTHS AGO.
PLAINTIFF ALLEGES HAVING ACQUIRED AN ALLERGY TO LATEX AS A RESULT OF CONTINUED CONTACT WITH LATEX GLOVES.
PT WAS BEING TREATED BY A CHIROPRACTOR AND ELECTRODE WAS APPLIED IN CONJUNCTION WITH MOIST HEAT PADS DURING THERAPY. PT SUBSEQUENTLY WAS BURNED DURING THIS PROCEDURE AND SOUGHT MEDICAL ATTENTION.
FACILITY ALLEGES BLOOD LEAK DURING TREATMENT; 23RD USE BLOOD WAS NOT RETURNED, RESULTING IN A BLOOD LOSS OF >100 CC. NO PT INJURY REPORTED.
PT ON WALL CPAP WHICH BEGAN 11/16/95. HE WENT INTO RESPIRATORY DISTRESS AND WAS CODED. BILATERAL PHEUMOTHORACES NOTED. PEEP VALVE WITH ADAPTER NOTED TO BE CONNECTED TO REVERSE FLOW.
BRONCHOSCOPY FORCEPS FRACTURED WHILE BIOPSY WAS BEING TAKEN. FORCEPS BECAME LODGED IN LUNG AND SEVERAL MINUTES OF MANIPULATION WERE REQUIRED TO EXTRACT THE FORCEPS. (*)
A 49-YR-OLD PT ADMITTED ON 11/29/95 WITH MALIGNANT EXTERNAL OTITIS AND PERICHONDRITIS OF RIGHT EAR. INFECTIOUS DISEASE CONSULTED AND IV ANTIBIOTICS BEGUN. PICC CATHETER INSERTED 12/11/95. WITHIN A FEW HOURS, PT DEVELOPED TEMPERATURES TO 104 DEGREES, DIARRHEA AND NAUSEA. MULTIPLE CAUSES RULED OUT. ON 12/15/95, PICC CATHETER DISCONTINUED AND PT'S TEMPERATURE RETURNED TO NORMAL WITHIN A FEW HOURS AND NAUSEA AND VOMITING SUBSIDED. DISCHARGED ON ORAL LIPROFLOXACIN. CATHETER IN RIGHT BASILIC VEIN.
SOURCE ADDED 500 CC OF NORMAL SALINE AND 250 ML OF TAXOL TO THE CONTAINER WHICH WAS THEN SPIKED WITH VENTED TUBING AND DELIVERED TO FLOOR. CONTAINER WAS PLACED ON THE COUNTERTOP. THE PT REPORTED A LOUD POP AND THE CONTAINER FELL TO THE FLOOR AND BROKE FURTHER.
NITROGLYCERIN TUBING HAS CLOUDY APPEARANCE. THIS HAS NEVER LOOKED LIKE THIS BEFORE. RPTR'S CONCERN IS THE INABILITY TO DISCERN IF A DRUG SHOULD PRECIPITATE IN THIS LINE.
WHILE UNDERGOING X-RAY PROCEDURE, X-RAY TUBE/COLLIMATOR DROPPED FROM A DISTANCE OF ABOUT 40 INCHES ON TO PT'S UPPER LEFT ABDOMEN (DIAPHRAGM AREA). THREE EMPLOYEES LIFTED EQUIPMENT OFF PT. PT TAKEN TO ER. DIAGNOSIS: CONTUSION LEFT LOWER CHEST WALL AND LEFT UPPER ABDOMEN.
PT DISCHARGED ON 11/17/95 WITH PICC, WHICH HAD BEEN REPAIRED THAT SAME DAY. PT SEEN AT HOME BY HOME HEALTH NURSE WHO TAUGHT WIFE TO ADMINISTER IV ANTIBIOTICS. HE RECEIVED SEVERAL DOSES OVER 2 1/2 DAYS WITHOUT PROBLEMS. SOMETIME DURING THE THIRD DAY, HE REPORTED TO HIS WIFE THAT HE FELT LIKE A NEEDLE WAS IN HIS ARM. SHE NOTIFIED HOME HEALTH. HE WAS DIRECTED TO COME TO ED. WHEN HE ARRIVED ONLY HUB OF CATHETER PRESENT. COULD NOT VISUALIZE ON X-RAY THAT DAY. VERY DIFFICULT TO VISUALIZE EVEN LATER.
DEVICE IS A DISPOSABLE PACING/DEFIB PAD USED WITH MFR'S DEFIBRILLATOR. IT WAS NOTICED THAT A PAD SPARKED WHILE IN USE ON A PT. PAD HAS BEEN SENT TO MFR FOR INVESTIGATION. IT HAS BEEN NOTICED ON SEVERAL LOTS THAT WHEN THE COVER IS PEELED OFF OF PAD THE PAD RIPS RENDERING IT INOPERABLE.
DURING PLACEMENT OF PORT, THE SILASTIC CATHETER WAS INSERTED THROUGH THE SLEEVE. IN THE MIDDLE OF THE INSERTION THERE WAS DIFFICULTY IN ADVANCING THE CATHETER. THE CATHETER WAS ADVANCED AND, AS THE SLEEVE WAS BEING RETRACTED AND SPLIT OPEN, IT WAS NOTED THAT AT THE MIDPOINT OF THE SLEEVE THE CATHETER WAS OUT OF THE SLEEVE CREATING A FALSE TRACT. A NEW CATHETER WAS INSERTED WITHOUT DIFFICULTY AND THERE WAS NO ADVERSE OUTCOME.
PLASTIC SHARDS SEEN IN DRIP CHAMBER OF IV TUBING IMMEDIATELY AFTER SPIKING IV BAG AND RUNNING A SMALL AMOUNT OF FLUID INTO TUBING.
HEART VALVE IMPLANTED IN 1981. VALVE RECALLED IN 1983. ALL APPROPRIATE REPORTING DONE AT THAT TIME. PT HAD ELECTIVE VALVE REPLACEMENT ON 1/4/96. NO PROBLEMS ASSOCIATED WITH THE VALVE OR VALVE MALFUNCTION PRIOR TO EXPLANTATION.
DURING IMPLANTATION IT WAS NOTED THAT HAPTICS ON ONE SIDE OF THE LENS WERE BROKEN. THEREFORE THE LENS WAS NOT USED. SURGERY WAS ABORTED AS UNABLE TO IMPLANT A 2ND LENS.
WITH 5 OUT OF 14 PORTS IMPLANTED AND UTILIZED IN 1995, RPTR EXPERIENCED INABILITY TO OBTAIN EXPECTED BLOOD SPECIMENS FROM PORTS. ALSO EXPERIENCED INSTANCES OF NEEDING TO REACCESS AND/OR REPOSITION NEEDLE TO FACILITATE INFUSION FLOW. UTILIZING ABOKINASE DID NOT PRODUCE DESIRED ANTICLOTTING EFFECT.
WHEN ATTACHING THE ACCESSORY HOLDER WITH THE LOWER WEDGE TRAY HOLDER ATTACHED, A GREEN LIGHT WAS OBTAINED INDICATING A SECURE (SAFE) MOUNT. AFTER LEAVING THE UNIT, THE HOLDER FELL TO THE FLOOR. FORTUNATELY, THE PT WAS NOT UNDER THE MACHINE, BUT COULD HAVE BEEN SERIOUSLY INJURED.
SCREWS WERE USED TO STABILIZE L4 + 5. RPTR WAS 28 YERS OLD. SHE KNOWS IF SHE HAD NOT BEEN FRIGHTENED INTO THE SURGERY, HER BACK WOULD HAVE HEALED WITHOUT SCREWS. SHE HAS HAD PROBLEMS EVER SINCE.
RUPTURED RIGHT BREAST IMPLANT. PT HAS SILICONE IMMUNE DYSFUNCTION, MASTODYNIA.
LEFT BREAST IMPLANT RUPTURED. RIGHT BREAST IMPLANT ENCAPSULATED.
MULTIPLE (50+) EMPLOYEES IDENTIFIED WITH LATEX ALLERGIES, SOME REQUIRING REMOVAL FROM HOSPITAL ENVIRONMENT.
WHILE SCREWING BLOOD COLLECTION NEEDLE INTO VACUTAINER A PIECE OF PLASTIC FLEW FROM HUB UP INTO EYE OF HEALTH CARE WORKER. (*)
CO BELIEVES THAT THIS ANALYSIS ELIMINATES ANY REPORTING REQUIRED BY MDR REGULATION, 21 CFR, SECTION 803.
RPTR STATES THE CHILD'S LEG WAS JAMMED BETWEEN THE CRIB RAILING AND THE MATTRESS FRAME AT THE FOOT OF THE CRIB. THE LEG WAS ABLE TO BE MOVED AFTER GENTLE MANIPULATION. THE DESIGN OF THE CRIB CREATES AN OPENING THAT NEEDS TO BE CLOSED WITH A SOFT MATERIAL TO PREVENT RECURRENCES OF THIS TYPE OF PROBLEM.
CASSETTE ON PUMP DISCONNECTED ABNORMALLY.
PACEMAKER WAS PUT IN RPTR 2/95. IMMEDIATELY AFTER SURGERY HE SAID "SOMETHING IS WRONG, I DON'T THINK ITS WORKING RIGHT." HE WAS TOLD EVERYTHING WAS FINE. HE CAME HOME THEN WENT BACK 3 DAYS LATER AND WAS STILL TOLD EVERYTHING WAS FINE. IN JULY HE WENT TO THE HOSP DUE TO PASSING OUT. HE WAS TOLD EVERYTHING WAS FINE. WHEN HE WAS IN A TELEMETRY BED HE WAS TOLD HE NEEDED IMMEDIATE SURGERY. PACEMAKER MALFUNCTIONING. LEAD WIRE LOOKED FRACTURED, WAS NOT CAPTURING. THIS EVENT HAS CAUSED HIM SIX OPERATIONS. THE LEADS AND PACEMAKER ARE DEFECTIVE.
THE CUSTOMER FAILED TO FOLLOW THE DIRECTIONS FOR THE ASSEMBLY OF A CAPILLARY TUBE INTO IT'S MICRO TUBE. THE CAPILLARY TUBE BROKE, CUTTING A PHLEBOTOMIST'S FINGER.
PLAINTIFF ALLEGES THAT WHILE ATTEMPTING TO UNLOAD VIALS OF BLOOD FROM A CENTRIFUGE, THE CENTRIFUGE LID FELL FROM ITS OPEN AND UPRIGHT POSITION, STRIKING THE PLAINTIFF.
FOLLOWING SURGERY, THE PAD WAS PLACED OVER SURGICAL SITE. THE COLD PACK PAD RUPTURED AND LEAKED CAUSING THE DRESSING OVER THE SURGICAL SITE TO BECOME WET. SUBSEQUENTLY, THE PT DEVELOPED AN INFECTION WHICH REQUIRED TREATMENT.
PIG TAIL BLOCKED "(AS NEW)" FLUID WILL NOT PASS. UNIT SET UP IN NEONATAL ICU. (LOOKS LIKE MFG PROBLEM.)
DURING PLACEMENT OF PORT, THE INTRODUCER (DILATOR) WAS TOO SOFT AND TORE ON TWO DIFFERENT KITS. A NEW CATHETER WAS INSERTED WITHOUT DIFFICULTY AND THERE WAS NO ADVERSE OUTCOME. KITS DISPOSED OF BEFORE BEING REPORTED.
SPINAL NEEDLE NUT IMPROPERLY WRAPPED OR ENCLOSED IN PLASTIC SHEATH. IT WAS LOOSE IN TRAY, THEREFORE IT IS NO LONGER STERILE OR IS A NEEDLE-STICK HAZARD.
FOUR PROBLEMS WITH THE FLUID WARMER SYSTEM HAVE BEEN ENCOUNTERED IN THE ENDOUROLOGY SUITE DURING UROLOGICAL SURGICAL PROCEDURES: 1. WHEN THE WARMING CASSETTE IS INSERTED INTO THE UNIT, FLOW DECREASES TO AN UNACCEPTABLE LEVEL. 2. STOPCOCKS HAVE INTERMITTENTLY FALLEN OFF OF THE TUBING SETS. THIS COULD BE A RESULT OF BACK PRESSURE WHICH DEVELOPS AS A RESULT OF PROBLEM #1. 3. THE LUER-LOCK FITTINGS BETWEEN THE STERILE TUBING SETS AND THE NONSTERILE TUBING ARE OCCASIONALLY TOO TIGHT AND CANNOT BE SEPARATED. 4. FITTINGS ON THE TUBING SETS ARE OCCASIONALLY INCOMPATIBLE: MALE AND MALE OR FEMALE AND FEMALE.
PLEASE BE ADVISED THAT THE BARD UROLOGICAL DIVISION WAS NOTIFIED OF THIS OCCURRENCE ON 01-17-96 AND HAS BEEN IN CONTACT WITH THE RPTR THROUGH FIELD ASSURANCE DEPT. AS THE EVENT DID NOT MEET THE CRITERIA OF A REPORTABLE EVENT AS OUTLINED IN 21 CFR 803.24, NO MDR WAS SUBMITTED AS A RESULT OF THIS REPORT.
VENTILATOR STOPPED DELIVERING TIDAL VOLUME. PT DUSKY -ABG'S DROPPED TO 7.1. DIDN'T INCREASE UNTIL VENTILATOR CHANGED. PT WAS PUT ON THE VENT ON 12/1/95. PT EXPIRED ON 12/7/95, 3 DAYS AFTER BEING TAKEN OFF THE VENTILATOR. THE VENTILATOR WAS INSPECTED ON 2/1/95 AND PASSED INSPECTION. ON 7/13/95 THE VENTILATOR AGAIN PASSED A COMPLETE BIO-MED INSPECTION. IT WAS LAST USED ON A PT ON 7/14/95 AND WAS OPERATIONAL AT THAT TIME.
UPON OPENING THE PRODUCT, THE CATHETER WALL WAS FOUND PUNCTURED BY THE NEEDLE.
PT FOUND WITH HEAD COMPLETELY THROUGH LEFT UPPER SIDERAIL.
CATHETER FRACTURED AND BROKE OFF EVEN WITH THE TOP OF THE PATIENT PORT, LEAVING APPROX 3/4 CM IMBEDDED IN THE PATIENT PORT.
DURING STEAM STERILIZATION, PROCESS INDICATOR TAPE BECOMES LOOSE AND ADHESIVE FAILS TO REMAIN ATTACHED TO PACKS IN THE AUTOCLAVE. ONLY THIS LOT APPEARS TO BE AFFECTED BY PROBLEM. TAPE FROM OTHER LOTS IS WORKING OK.
EMT'S RESPONDED TO AN EMERGENCY CALL AND FOUND A MALE PT PULSELESS AND UNRESPONSIVE. DEFIBRILLATOR APPLIED AND PT FOUND TO BE IN A SHOCKABLE RHYTHM. DEVICE CHARGED TO 200J AND WHEN SHOCK APPLIED, DEFIBRILLATOR MADE A LOUD "SHOTGUN" NOISE AND FIRE CAME OUT OF THE APEX PANEL. PT REGAINED PULSE, WAS TRANSFERRED TO A SECOND DEFIBRILLATOR AND TRANSPORTED TO THE HOSPITAL WHERE HE EXPIRED 2-3 DAYS LATER.
THREE SNARES BUCKLED AT THE HANDLE WIRE WHEN OPENED DURING PROCEDURE. SNARE FROM A DIFFERENT LOT NUMBER USED WITHOUT PROBLEM. NO INJURY TO PT.
THIS IS A ONE-DAY-OLD CHILD, WHO HAD PROFOUND RESPIRATORY FAILURE FROM MECONIUM ASPIRATION AND MOST RECENTLY IDENTIFIED GROUP B STREP SEPSIS. SHE FAILED CONVENTIONAL VENTILATION, HIGH-FREQUENCY VENTILATION AND NITROUS OXIDE. RPTR WAS ASKED TO PUT HER ON ECMO. THE CHILD WAS PREPPED AND DRAPED IN STANDARD FASHION. AN INCISION WAS MADE IN THE LOWEST FLEXION CREASE IN THE NECK OVER THE INTERNAL JUGULAR VEIN. THE VEIN WAS DISSECTED FREE, A PROXIMAL TIE WAS PLACED AND DISTAL CONTROL WAS ESTABLISHED. A VENOTOMY WAS MADE AND A #12 FRENCH DOUBLE-LUMEN VV ECMO CANNULA WAS INSERTED INTO THE SUPERIOR VENA CAVA AND THEN TIED IN PLACE. THE CHILD WAS PLACED ON ECMO. THE CHILD THEN HAD AN X-RAY WHICH CONFIRMED THE VV CANNULA WAS IN GOOD POSITION. THE FLOW WAS VERY SLOWLY INCREASED OVER A PERIOD OF 15 MINUTES, BUT RPTR COULD NOT EXCEED 220 CC OF FLOW PER MINUTE WHICH WAS NOT ENOUGH TO OXYGENATE THIS BABY. THE X-RAY DEMONSTRATED A SMALL KINK IN THE CATHETER. THE NECK WAS REOPENED, THE TIES WERE IDENTIFIED. THERE WAS A LONGITUDINAL KINK IN THE CATHETER, LIKE A GROOVE. BY REPLACING THE TIES RPTR COULD NOT GET THE CATHETER TO POP OUT. THE DECISION WAS MADE TO REPLACE IT WITH A NEW ONE. IT WAS WITHDRAWN. A NEW CATHETER WAS PASSED DOWN THE VENA CAVA BUT WOULD NOT PASS MORE THAN 4 CM, WHICH WAS NOT SUFFICIENT TO GET THE LAST VENOUS DRAINAGE HOLE INSIDE THE VEIN. MULTIPLE ATTEMPTS WERE MADE TO PASS THIS CATHETER IN A PHYSIOLOGIC MANNER. THE VEIN SEPARATED WITH RESULTANT HEMORRHAGE. APPROX 20-30 MINUTES WERE USED TO ATTEMPT TO GET VASCULAR CONTROL FAILED TO PASS A #12 FRENCH STANDARD VENOUS CATHETER. A #10 FRENCH CATHETER ALSO FAILED TO PASS BEYOND 4 CM. THE CHILD CONTINUED TO HEMORRHAGE AND DESPITE REPLACEMENT, SHE WENT ON TO ARREST AND THE PROCEDURE WAS TERMINATED. THE WOUND WAS CLOSED IN LAYERS USING FINE NYLON.
PT HAD DRAIN SUTURED DURING RECTOSIGMOID RESECTION. DRAIN REMOVED ON 1/9/96 AND TUBING "FRACTURED" AT SUTURE SITE; REMAINING RETAINED PORTION REMOVED DURING SECOND EXPLORATORY LAP. DISCHARGED FROM HOSP 1/10/96; NO INJURY.
PT HAS DEVELOPED LUPUS AND HAS ALSO NOTED ASYMMETRY OF THE BREAST WITH THE LEFT BREAST BECOMMING WRINKLED AND SMALLER THAN THE RIGHT. IMPLANTS NOT PUT IN AT RPTR'S FACILITY.
WHILE USING THE ELECTROSURGICAL UNIT (ESU) ON THE RIGHT UPPER ARM INCISION, A BLISTER APPROX THE SIZE OF A DIME WAS NOTED. THE ESU PENCIL WAS BEING USED TO COAGULATE BLEEDING VESSELS NEAR THE SKIN. THE BLISTER WAS NOTED WHEN CLOSING THE INCISION. INCISION WAS CLOSED AND ANTIBIOTIC OINTMENT APPLIED TO THE AREA.
PERSONAL EMERGENCY RESPONSE SYSTEMS, INC. 5777 WEST CENTURY BLVD, STE 1490, LOS ANGELES,CA 90045. THE PURPOSE OF THIS LETTER IS TO INFORM YOU THAT MY CO DOES NOT BELIEVE THE EVENT REFERENCED ABOVE IS REPORTABLE BY US DUE TO THE FACT THAT WE DID NOT MFG THE EQUIPMENT IN QUESTION.
RPTR DEVELOPED BREAST CANCER 6/94 AND HAD SURGERY 10/94. SHE UNDERWENT CHEMOTHERAPY AND RADIATION NOV-APRIL. IT AFFECTED HER WAGES DURING THAT TIME. (ALSO SEE 1008188)
PT DEVELOPED BREAST CANCER 6/94 AND HAD SURGERY 10/94. SHE UNDERWENT CHEMOTHERAPY AND RADIATION NOV-APRIL. IT AFFECTED HER WAGES DURING THAT TIME. (ALSO SEE 1008187)
RPTR HAD BREAST IMPLANTS PUT IN FOLLOWING MASTECTOMY FOR FIBROCYSTIC DISEASE. SHE HAS HAD HER BREAST IMPLANTS REPLACED TWICE. SHE HAS HAD A TOTAL OF 3 BREAST SURGERIES ON EACH BREAST INCLUDING THE FIRST IMPLANT SURGERY. SHE HAD CALCIUM DEPOSITS. A MEDICAL PROFESSIONAL HAS CONFIRMED THE PRESENCE OF SILICONE IN THE LEFT THIGH. SHE HAS HAD INFECTION AND NUMBNESS IN THE SURGICAL AREA, IMPLANT RUPTURE. SHE C/O BLADDER/CHRONIC URINARY  INFECTIONS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, OTHER NEUROPATHY, CARPAL TUNNEL SYNDROME, BRAIN LESIONS, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ORGANIC BRAIN SYNDROME, REDUCED BLOOD FLOW TO BRAIN. CHEST/RIB CAGE: PAIN &/OR BURNING SENSATION, INFLAMMATION, ELEVATED CHOLESTEROL OR TRIGLICERIDES, EYES: NERVE DAMAGE, THYROID PROBLEMS, ADRENAL PROBLEMS, CHRONIC SWELLING AND PAIN, HEAT OR COLD SENSITIVITY OF THE EXTREMITIES, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME. HYPERSENSITIVITY OR ALLERGIES TO: CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS. UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, SJOGREN'S SYNDROME, JOINTS: INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, ELEVATED LIVER ENZYMES,   CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY UNDER ARMS, GROIN, RIB CAGE, NECK, FACE, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, MYOSITIS OR POLYMYOSITIS, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, NON-RESTORATIVE SLEEP, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPS THINGS, MISJUDGES DISTANCE/RUN INTO OBJECTS. (*) (ALSO SEE 1008190)
RPTR HAD BREAST IMPLANTS PUT IN FOLLOWING MASTECTOMY FOR FIBROCYSTIC DISEASE. SHE HAS HAD HER BREAST IMPLANTS REPLACED TWICE. SHE HAS HAD A TOTAL OF 3 BREAST SURGERIES ON EACH BREAST INCLUDING THE FIRST IMPLANT SURGERY. SHE HAD CALCIUM DEPOSITS. A MEDICAL PROFESSIONAL HAS CONFIRMED THE PRESENCE OF SILICONE IN THE LEFT THIGH. SHE HAS HAD INFECTION AND NUMBNESS IN THE SURGICAL AREA, IMPLANT RUPTURE AND BLEEDING. SHE C/O BLADDER/ CHRONIC URINARY INFECTIONS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, OTHER NEUROPATHY, CARPAL TUNNEL SYNDROME, BRAIN LESIONS, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ORGANIC BRAIN SYNDROME, REDUCED BLOOD FLOW TO BRAIN. CHEST/RIB CAGE: PAIN &/OR BURNING SENSATION, INFLAMMATION, ELEVATED CHOLESTEROL OR TRIGLICERIDES, EYES: NERVE DAMAGE, THYROID PROBLEMS, ADRENAL PROBLEMS, CHRONIC SWELLING AND PAIN, HEAT OR COLD SENSITIVITY OF THE EXTREMITIES, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME. HYPERSENSITIVITY OR ALLERGIES TO: CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS. UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, SJOGREN'S SYNDROME. JOINTS: INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, ELEVATED LIVER ENZYMES,   CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY UNDER ARMS, GROIN, RIB CAGE, NECK, FACE, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, MYOSITIS OR POLYMYOSITIS, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, NON-RESTORATIVE SLEEP, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPS THINGS, MISJUDGES DISTANCE/RUN INTO OBJECTS. (*) (ALSO SEE 1008189)
RPTR HAD BREAST IMPLANTS PUT IN FOLLOWING MASTECTOMY FOR FIBROCYSTIC DISEASE. SHE HAS HAD HER BREAST IMPLANTS REPLACED TWICE. SHE HAS HAD A TOTAL OF 2 BREAST SURGERIES ON EACH BREAST. SHE HAD CALCIUM DEPOSITS AND A MEDICAL PROFESSIONAL HAS CONFIRMED SILICONE IN THE BLOOD STREAM. HER IMPLANTS WERE RUPTURED. SHE HAS HAD 2 PARTIAL OPEN CAPSULOTOMIES. SHE C/O LOW BLOOD PRESSURE, ANXIETY AND/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, STROKE, REDUCED BLOOD FLOW TO BRAIN (BLOOD CLOT), CHEST/RIB CAGE: PAIN &/OR BURNING SENSATION, ELEVATED CHOLESTEROL OR TRIGLICERIDES, CHRONIC SWELLING AND PAIN, HEAT OR COLD SENSITIVITY OF THE EXTREMITIES, FREQUENT LOW GRADE FEVER, ENDOMETRIOSIS, FREQUENT MIGRAINES/SEVERE HEADACHES, MITRAL VALVE PROLAPSE, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, LUPUS, JOINTS: INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT STIFFNESS, UNEXPLAINED RASHES, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, LONG-TERM EXTREME FATIGUE AND MISJUDGES DISTANCE/RUNS INTO OBJECTS. (*) (ALSO SEE 1008189)
AT AGE 42 RPTR HAD MIGRAINE HEADACHES AND NAUSEA FOLLOWED TWO YEARS LATER BY GRAND MAL SEIZURES. DIAGNOSED AS MANIC DEPRESSIVE. SHE HAD ARM SURGERY IN 1993 AND LEG SURGERY IN 1995, CARPAL TUNNEL, GALL BLADDER SURGERY. PAIN IN JOINTS, DIFFICULTY WALKING, UNSTABLE, TOO ILL TO WORK AND PLACED ON SOCIAL SECURITY. SHE C/O HYPERTENSION, LEFT CHEST PAIN, ASTHMA. MEMORY LOSS. SHE STARTED DRINKING IN 1989 DUE TO DEPRESSION AND ISOLATION, WENT TO AA RECOVERY. THE IMPLANT WAS RUPTURED.
AUTOPSY PERFORMED ON PT WITH INTRACTABLE HEART FAILURE DUE TO LATE SEQUELAE OF TRANSPOSITION OF GREAT ARTERIES AND MUSTARD PROCEDURE PERFORMED AT 20 MONTHS OF AGE. MINISCULE HOLE NOTED AT THAT TIME TO BE PRESENT IN THE BALLOON CATHETER WHICH HAD BEEN INSERTED ON 11/26/95.
ON 6/24/87 AT AGE 39, RPTR HAD A SECOND SURGERY TO REPLACE ONE COLLAPSED SILICONE IMPLANT. ON 2/13/91 AT AGE 43, SHE HAD A THIRD SURGERY TO REPLACE THE SECOND COLLAPSED SILICONE IMPLANT. THE DOCTOR REMOVED BOTH IMPLANTS AND REPLACED THEM. SHE HAS BEEN HOSPITALIZED DUE TO LOW IMMUNE SYSTEM. SHE HAS BEEN DIAGNOSED WITH FIBOMYALGIA.
A PIECE OF THE PLASTIC SLEEVE BROKE AND FOUND ITS WAY INTO THE IV TUBING. NURSE DETECTED IT BEFORE IT REACHED THE PT.
A PT WAS SCHEDULED TO RECEIVE 22 RX'S, 200 CGY/RX, THROUGH OPPOSING LATERAL FIELDS TO THE NECK AREA. THE FIRST FOUR RX'S WERE DELIVERED WITHOUT INCIDENT AND PROPERLY RECORDED BY THE SYSTEM. ON THE 5TH DAY OF TREATMENT, THE FIRST FIELD WAS SUCCESSFULLY TREATED AND RECORDED BY THE SYSTEM. THE TECHNOLOGISTS ENTERED THE ROOM TO SETUP THE SECOND FIELD USING THE PENDANT AUTOSET FUNCTION. THE CORRECT SETTING FOR THE Y2 JAW WAS SEEN ON THE ROOM MONITOR AS Y2=6.5. AS THE TECHS LEFT THE ROOM, A "?" APPEARED ON THE SCREEN INDICATING THE SYSTEM WAS HAVING DIFFICULTY RECOGNIZING THAT A BLOCKING TRAY WAS IN PLACE. USING THE AUTOSET FROM THE OPERATOR'S CONSOLE, THE TRAY INHIBIT WAS ELIMINATED AND THE RADIATION START BUTTON WAS PRESSED. A MESSAGE WAS BRIEFLY DISPLAYED INDICATING "DIAPHRAGM OUT OF RANGE." THIS QUICKLY DISAPPEARED, HOWEVER, AND RADIATION CONTINUED TO BE PRODUCED UNABATED. THE BEAM CALLED FOR 138 MU'S TO DELIVER 100 CGY. AFTER GIVING 52 MU'S THE TECHS NOTICED THAT THE "PRESCRIBED", "SET" AND "RUN" VALUES FOR THE Y2 JAW HAD BEEN CHANGED TO 7.4. TREATMENT WAS IMMEDIATELY INTERRUPTED. PHYSICS AND THE MFR'S SERVICE ENGINEER WERE NOTIFIED. THE PT WAS REMOVED FROM THE ROOM AND ASKED TO WAIT OUTSIDE. BOTH THE OPERATOR'S MONITOR AND THE ROOM MONITOR INDICATED Y2-7.4 AND THIS WAS VERIFIED BY MEASURING THE OPTICAL FIELD SIZE. A CHECK OF THE LCD DISPLAY INDICATED THAT 52 MU'S HAD BEEN DELIVERED THROUGH THE LARGER-THAN-INTENDED FIELD. THE FIELD WAS RESTARTED AND DELIVERED THE REMAINING 85 MU'S WITH Y2=7.4 WITHOUT ANY MESSAGES OR INHIBITS APPEARING. THE PT'S FILE WAS BROUGHT UP AND "TREATED" TWICE WITH NO REPETITION OF THIS ERROR (IE Y2 HAD BEEN RESTORED TO THE CORRECT VALUE OF 6.5). AFTER RECEIVING THE PERMISSION OF THE MEDICAL DIRECTOR, THE PT WAS RETURNED TO THE ROOM AND THE REMAINING 85 MU'S OF THE SECOND FIELD WERE SUCCESSFULLY GIVEN ALONG WITH TREATMENT OF A DIFFERENT REGION. THREE OTHER PTS WERE THEN TREATED WITHOUT INCIDENT. THE MFR'S SERVICE ENGINEER PERFORMED A "DISK VERIFY" PROCEDURE ON THE SYSTEM'S HARD DRIVE. NO ERROR WERE DETECTED. INSPECTION OF THE MACHINE'S DAILY RECORD INDICATES THAT A "TERMINATION CODE - 813" WAS RECORDED, EVEN THOUGH THE BEAM ITSELF WAS NEVER TERMINATED. PHYSICIAN REVIEW OF THE PT'S TREATMENT AREA INDICATES NO EXPECTATION OF UNTOWARD EFFECTS FROM THE 52 MU'S DELIVERED WITH Y2=7.4 RATHER THAN 6.5. THE TECHNOLOGISTS ARE BEING INSTRUCTED TO CAREFULLY MONITOR EACH PT TREATMENT.
THE INCUBATOR WAS DISPLAYING ALL MEASUREMENTS AND SETTINGS AS IF IN NORMAL OPERATION, HOWEVER, THE INCUBATOR APPEARED NOT TO MAINTAIN THE TEMPERATURE OF THE BABY. THE BABY'S TEMP WAS MEASURED RECTALLY AND FOUND TOO LOW, WITH AN INCUBATOR SETTING AT 35 - 36 DEGREES CELSIUS.
ANIMALS PUT UNDER GAS ANESTHESIA, 3 LITER BAG USED. OXYGEN FLOW SET AT 1L OR 0.6L. POP OFF VALVE ALL THE WAY OPENED. 3L BAG FILLS TO EXPANSION ACCORDING TO O2 FLOW, IE AT 0.6L 3L BAG FILLS IN 5 1/2 TO 6 MINUTES. BAG DOES NOT DEFLATE AT ALL AND CONTINUES TO FILL SO THE DOG (NO MATTER WHAT SIZE) CANNOT INHALE AND EXHALE AGAINST THE FILLED BAG. BAG THEN EMPTIED SO PROCESS CAN BEGIN AGAIN. NECESSITATE EMPTYING GAS INTO SURGERY ROOM. THE MACHINE DOES THIS EVEN WITH JUST THE O2 ON AND VAPORIZER OFF. THE RPTR PURCHASED THE ANESTHESIA MACHINE FROM THE MFR THREE YEARS AGO. SHE NOTED THE DESCRIBED MALFUNCTION IMMEDIATELY. WITH THE POP-OFF VALVE IN A FULLY OPEN POSITION, THE PRESSURE IN THE RESERVOIR BAG BUILDS UP TO THE POINT WHERE THE ANIMAL CAN NO LONGER BREATH. APPROXIMATELY 225 ANIMALS HAVE BEEN ANESTHETIZED WITH THIS MACHINE OVER THE PAST THREE YEARS. IT MALFUNCTIONS IN EVERY CASE, NECESSITATING THE SURGICAL TECHNICIAN TO DISCONNECT THE ANIMAL FROM THE MACHINE SEVERAL TIMES DURING THE PROCEDURE TO RELEASE THE GAS INTO THE ROOM. THE TIME BETWEEN INITIATION OF THREAPY AND ONSET OF THE REACTION IS THREE TO FIVE MINUTES. ONE ANIMAL DIED FROM PNEUMOTHORAX, THE REST RECOVERED. THERE IS A HIGH LEVEL OF SUSPICION THAT THE MACHINE CAUSED THE REACTION. THE RPTR HAS CONTACTED THE MFR NUMEROUS TIMES. THE MACHINE WAS RETURNED FOR EVALUATION TWICE. THE MFR TOLD THE RPTR THAT THE MACHINE WAS FUNCTIONING PROPERLY IN BOTH CASES. FIELD REPRESENTATIVES HAVE BEEN OUT TO HER CLINIC TO TEST THE MACHINE SEVERAL TIMES AND ALSO HAVE TOLD HER IT IS FUNCTIONING FINE. SHE ANESTHETIZED AN ANIMAL TO DEMONSTRATE THE PROBLEM FOR A FIELD REPRESENTATIVE, AND HE DID ACKNOWLEDGE THAT A PROBLEM DID INDEED EXIST; HOWEVER THE PROBLEM REMAINS UNCORRECTED. THE RPTR NOTES THAT THE MFR WILL NO LONGER RETURN HER TELEPHONE CALLS. TO CONTINUE OPERATING THE ANESTHSIA MACHINE IN THIS MANNER IS UNSAFE FOR THE OR PERSONNEL AS ANESTHETIC GAS IS DIRECTLY RELEASED INTO THE ROOM AT REGULAR INTERVALS.
RPTR C/O EXCESSIVE CAPSULATION, HARD. LUMPY BREAST CAUSING PAIN IN CHEST AREA, CREATING RPOBLEMS IN NECK SHOULDER AND CHEST AREA, FIBROMYALGIA, SHOULDER SURGERY, BREAST EXPLANTATION, CYST IN BREAST. SHE IS CONSTANTLY IN PAIN THROUGHOUT HER BODY, HAS FREQUENT INFLAMMATION, URINARY TRACT PROBLEMS AND OTHER PROBLEMS TOO NUMEROUS TO LIST.
PT HAD HYPOTENSIVE CRISIS NOT RESPONDING TO ADVANCED CARDIAC LIFE SUPPORT, IMMEDIATELY FOLLOWING INSERTION OF HIP CEMENT (METHYL METHACRYLATE).
THE GUIDE WIRE DID NOT FEED EASILY, THEN WAS DIFFICULT TO REMOVE. WHEN THE GUIDE WIRE WAS REMOVED, IT CAME OUT KINKED OR COILED. THIS OCCURRED WITH TWO DIFFERENT PHYSICIANS. THIS HAPPENED WITH APPROXIMATELY 5-8 KITS. THIS PROBLEM HAS ALREADY BEEN REPORTED TO THE SALES REPRESENTATIVE.
RPTR STATES SHE HAS SECOND SET OF SALINE BREAST IMPLANTS THAT RUPTURED. SHE HAS FELT GENERALLY UNCOMFORTABLE AND DEVELOPED CELLULITUS DURING THE PAST THREE YEARS.
RPTR C/O ERYTHEMA AND BLISTERING UNDER THE PRESSING WHICH PROGRESSED TO SEVERE WEEPING CELLULITIS AND WORSENING ERYTHEMA. CELLULITIS EVENTUALLY RESOLVED. DRESSING WAS FIRT APPLIED ON 8/4/95 AND REMOVED 8/6/95.
BLISTERING NOTED UNDER DRESSING 5 DAYS AFTER PLACEMENT OF THE DRESSING. LONG TERM OUTCOME UNKNOWN. "WOUND" CLEANED AND H2O2 AND BETADINE. NO ANTIBIOTICS GIVEN. DRESSING REPLACED WITH "TRADITIONAL DRESSING."
RPTR STATES MFR CLAIMS THAT THERE IS A UNIQUE RESPONSE CONSISTENT TO THE SIZING OF THE GRAFT. THEY CLAIM THAT THEIR PARTICLES ARE MADE IN THE 300-350 MICROGRAM RANGE, BUT TO THE NAKED EYE, THE PRODUCT LOOKS EXACTLY LIKE ANOTHER RPODUCT, WHICH IS IN THE 90-710 MICROGRAM RANGE. IN ADDITION, SINCE PUBLISHED STUDIES EXIST, WHICH DEMONSTRATE CAVITATION IN PARTICLES OUTSIDE THE 300-350 MICROGRAM RANGE, RPTR ASK WHY DOES MFR MAKE A UNIQUE CLAIM THAT AS A RESULT OF ITS OPTIMAL SIZE RANGE (300-355 MICROGRAMS), THE PRODUCT IS TRANSFORMED INTO HOLLOW CALCIUM PHOSPHATE BONE CHAMBERS. ACCORDING TO RPTR ON THE SURFACE SIZING AND UNIQUE RESPONSE CLAIMS WOULD APPEAR TO BE MISLEADING AND/OR FALSE. (*)
RPTR CALLED TO REPORT PROBLEMS WITH FALSE NEGATIVE TEST RESULTS. THE FIRM WAS DOING SIDE BY SIDE VALIDATION OF THE CMV LGG TEST KITS USING TWO LOT NUMBERS WITH THE FIRST LOT OUT OF 40 SAMPLES, THERE WERE 16 NEGATIVE RESULTS. 8 OF 16 WERE DETERMINED TO BE FALSE NEGATIVES. WITH THE SECOND LOT OUT OF 12 SAMPLES, THERE WERE 6 NEGATIVE RESULTS. 4 OF 6 WERE FALSE NEGATIVES. RPTR DID NOT REPORT THE RESULTS OF MFR. THE FIELD OFFICER INDICATED IT WAS IMPORTANT TO DO SO BECAUSE THE FIRM NEEDED TO CONDUCT AN INVESTIGATION INTO THE MATTER AND POSSIBLY INITIATE A RECALL. TESTING WAS DONE IN 8/95, WAS TOLD IT COULD BE DEVASTATING FOR ORGAN RECIPIENTS.
RPTR PURCHASED THE HEARING AID IN 11/94. IT BEGAN TO SQUEAL AFTER BEING WORN FOR A SHORT PERIOD OF TERM. IT HAS RETURNED SEVERAL FOR REPAIR. THE PROBLEM STILL OCCURS.
UNDERWENT EXPLANTATION OF LEFT BREAST IMPLANT AND CAPSULECTOMY. IMPLANT WAS INTACT UPON DELIVERY.
CAPSULAR CONTRACTURE AND DEFORMITY OF BILATERAL BREAST IMPLANTS WITH PAIN. BREAST IMPLANTS REMOVED AND REPLACED WITH SALINE IMPLANT.
INTRA-AORTIC BALLOON PUMP ALARMED "AUTOFILL" FAILURE. BLOOD SEEN IN BALLOON CATHETER. PATIENT LOST AUGMENTED BLOOD PRESSURE AND EXPIRED.
PLATE IMPLANTED ON 12/4/95. MALUNION OF BONE FRACTURE REQUIRED EXPLANT ON 12/11/95.
TWO SEPARATE DRAINS BROKE DURING REMOVAL PROCESS LEAVING APPROXIMATELY 4-5 INCHES OF BOTH DRAINS IN WOUND.
FAMILY REPORTED PT DIED FROM SUFFOCATION FROM GETTING BETWEEN HOSPITAL BED AND BED RAILS. CERTIFICATE OF DEATH SAID "CARDIORESPIRATORY ARREST DUE TO ALZHEIMER'S DEMENTIA." (ALSO SEE 4001036)
FAMILY REPORTED PT DIED FROM SUFFOCATION FROM GETTING BETWEEN HOSPITAL BED AND BED RAILS. CERTIFICATE OF DEATH SAID "CARDIORESPIRATORY ARREST DUE TO ALZHEIMER'S DEMENTIA." (ALSO SEE 4001029)
WHEN NEEDLE WAS INTRODUCED INTO TISSUE, THE NEEDLE BROKE FROM THE SUTURE. NEEDLE COULD NOT BE LOCATED.
PT INITIATED ON DIALYSIS TREATMENT #9 AND WITHIN MINUTES BECAME SHORT OF BREATH AND PROCEEDED TO A RESPIRATORY/CARDIAC ARREST AND DIED AFTER UNSUCCESSFUL CPR. THE DIALYZER WAS A MFR STERILIZED DIALYZER, FIRST USE; STERILANT WAS ETHYLENE OXIDE. FOLLOW-UP LAB WORK AFTER EVENT INDICATED A POSITIVE IGE AND ANTIBODY FOR ETO. FACILITY BELIEVES PT HAD AN ANAPHYLACTIC REACTION TO ETO.
PSYCHIATRY PT SLIPPED BETWEEN BED RAILS AND FRACTURED TIBIA/FIBULA.
DURING CODE CENTRAL LINE SNAPPED WHILE SUTURE WAS BEING APPLIED. PT CODED TWICE AFTERWARDS AND EXPIRED.
ON 2/19/94 RESIDENT WAS FOUND LODGED BETWEEN THE MATTRESS AND THE SIDE RAIL ATTACHED TO BED. TORSO WAS COMPLETELY THROUGH SPACE WITH CHIN RESTING ON LOWER BAR OF SIDE RAIL. PT WAS DEAD. BODY TAKEN BY CORONER FOR AN AUTOPSY BY MEDICAL EXAMINER. INCIDENT REPORTED TO THE DOH. INTERNAL INVESTIGATION IN PROGRESS.
ON 6/29/95, A THIRTY-TWO YEAR OLD MALE WAS ADMITTED FOR ARTHROSCOPIC REPAIR OF WORK-RELATED LEFT KNEE INJURIES. PRE-ADMISSION MRI HAD REVEALED A RUPTURED VASTUS MEDIALIS AND MEDIAL RETINACULUM AND A CONTUSION OF THE MEDIAL FEMORAL CONDYLE. DURING THE PROCEDURE, THE SURGEON REQUESTED THAT HIS ELECTROSURGICAL UNIT BE BROUGHT IN. THE PT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE PACU FOR RECOVERY. WHEN BEING PREPARED FOR DISCHARGE PT COMPLAINED OF ITCHING IN THE ANTERIOR RIGHT UPPER THIGH. WHEN EXAMINED, A 2CM IRREGULARLY SHAPED AREA WITH BROWN SLOUGHED SKIN WAS IDENTIFIED. A PLASTIC SURGEON DIAGNOSED A CAUTERY ARC BURN MEDIAL TO WHERE THE GROUNDING PAD HAD BEEN PLACED. A THIRD DEGREE BURN WAS IDENTIFIED IN THE CENTRAL AREA WITH SECOND DEGEREE IN THE PERIPHERY. SILVADINE OINTMENT WAS APPLIED AND THE PT WAS DISCHARGED IN STABLE CONDITION. IT IS ANTICIPATED THAT INJURY WILL HEAL WITH CONSERVATIVE TREATMENT. THE ELECTROSURGICAL ARTHROSCOPY GENERATOR AND DISPERSIVE PAD USED DURING THE PROCEDURE WERE SEQUESTERED AND SENT TO THE BIOMEDICAL ENGINEERING DEPT FOR INSPECTION AND TESTING. THE GENERATOR, OWNED BY THE SURGEON, BUT MAINTAINED IN THE HOSP, WAS TESTED WITH A 500 OHM LOAD; NO DEFECT OR MALFUNCTION IN PERFORMANCE AND/OR ELECTRICAL OUTPUT WAS IDENTIFIED. THE PAD WAS NOTED TO HAVE HAIR ADHERED TO IT. DISCUSSION WITH THE NURSE WHO APPLIED THE PAD TO THE PT'S RIGHT THIGH FOR GROUNDING PRIOR TO CAUTERY BY HIS SURGEON REVEALED THAT THE AREA TO WHICH THE PAD WAS PLACED HAD NOT BEEN SHAVED PRIOR TO ADHERENCE. THE INCIDENT HAS BEEN REVIEWED WITH THE INVOLVED NURSE AND THE SURGE0N. THE NURSE HAS BEEN COUNSELED AS TO THE IMPORTANCE OF FOLLOWING PRODUCT INSTRUCTIONS. THE SURGEON HAS BEEN INFORMED THAT THE ARTHROSCOPY GENERATOR IS BEING TAKEN OUT OF SERVICE BECAUSE IT HAS NO RETURN ELECTRODE/IMPEDANCE MONITORING ALARM CIRCUITRY WHICH WOULD HAVE WARNED THE OPERATING ROOM STAFF IF THE GROUND PAD WAS NOT IN PLACE. AN ELECTROSURGICAL ARTHROSCOPY GENERATOR WHICH HAS SUCH AN ALARM SYSTEM BUILT INTO IT IS BEING USED AND THE PURCHASE OF REPLACEMENT EQUIPMENT WHICH HAS A BUILT-IN ALARM SYSTEM IS BEING EXPLORED.
PT BEING RESTRAINED BY RESTRAINT, SLID OUT OF BED BETWEEN SIDE RAILS AND WAS STRANGLED.
DURING AN ERCP, A STONE RETRIEVAL BASKET WAS USED TO RETRIEVE A COMMON BILE DUCT STONE. PER MFR'S DIRECTIONS, THE BASKET WAS ATTACHED TO THE MECHANICAL LITHOTRIPSY HANDLE. WHILE "CRANKING" THE BASKET TO CRUSH THE STONE, ALL FOUR WIRES OF THE BASKET BROKE. THE WIRES WERE STABILIZED WITH A HEMASTAT AND TAPED TO PT'S FACE. SEVERAL ATTEMPTS WITH THE SCOPE AND OTHER ACCESSORIES TO REMOVE THE WIRES WERE UNSUCCESSFUL. PT TAKEN T0 SURGERY FOR REMOVAL OF WIRES AND STONE. PT RECOVERING WELL.
ENTERAL FEEDING TUBE INSERTED WITHOUT DIFFICULTY. X-RAY DONE, REPORT SHOWED THAT TUBE WAS IN THE LUNG. NURSE CONTACTED TO REMOVE FEEDING TUBE IMMEDIATELY. TUBE REMOVED WITHOUT DIFFICULTY. PT DEVELOPED RESPIRATORY DISTRESS. NURSE ATTEMPTED TO SUCTION AND BAG PT. NURSE MET GREAT RESISTANCE WITH BAGGING. PT CONTINUED TO HAVE RESPIRATORY DISTRESS. HEART RATE DECREASED AND A CODE WAS CALLED. THE ER PHYSICIAN ASSESSED PT'S AIRWAY, REPLACED HER TRACHEOSTOMY TUBE, THEN FINALLY PLACED BILATERAL CHEST TUBES. CPR WAS DONE THROUGHOUT. PT EXPIRED. THE DESIGN OF THE FEEDING TUBE, ESPECIALLY THE FACT THAT THE MERCURY TIP IS THE SAME DIAMETER AS THE FEEDING TUBE MAY CONTRIBUTE TO GREATER RISK OF PENETRATING LUNG. WHEN LEFT CHEST TUBE WAS INSERTED, PT HAD CLOSE TO A LITER RETURN.
POCKET WHERE GENERATOR POSITIONED WAS INFECTED. MOVED AND REPLACED GENERATOR TO NEW SITE.
LEAD IMPLANTED IN 1989. WITH RECENT INCREASE IN SYNCOPE, AN EKG INDICATED NON-SENSING AND IT WAS FELT THAT PT MAY HAVE AN INSULATION BREAK. PT WAS PROGRAMMED TO THE VOO MODE AND WAS RECOMMENDED FOR LEAD REPLACEMENT.
PT PRESENTED WITH PAIN IN RIGHT UPPER BREAST AND ALSO SOME ANKLE PAINS. SHE HAD HAD BILATERAL BREAST AUGMENTATION IN 1982. MAMMOGRAM IN 1995 SHOWED BILATERAL RUPTURE OF IMPLANTS. SHE HAD CAPSULAR CONTRACTURE OF BOTH BREASTS. SHE HAD TOTAL CAPSULECTOMY OF RIGHT AND LEFT BREASTS; REMOVAL OF RUPTURED IMPLANTS AND IMPLANT MATERIAL RIGHT AND LEFT BREASTS; INSERTION OF SALINE IMPLANTS.
PT HAD BILATERAL BREAST IMPLANTS IN 1975. PRESENTED WITH BILATERAL CAPSULAR CONTRACTURE WITH CALCIFIED CAPSULE. SHE HAD AN OPEN CAPSULOTOMY AND CAPSULECTOMY, BILATERAL, WITH REMOVAL OF IMPLANTS AND IMPLANT MATERIAL; REIMPLANTATION OF SALINE IMPLANTS; AND REVISION OF SCARS OF BREASTS, BILATERALLY.
WHEN PTCA BALLOON CATHETER WAS INSERTED INTO GUIDE CATHETER, IMMEDIATE BLOOD BACK FLOW INTO INFLATION DEVICE OCCURRED. THE CATHETER WAS NEVER INFLATED. THE SECOND BALLOON OPENED FOR PROCEDURE.
MY HLTH IN LAST FEW YR'S, IN AND OUT OF HOSP. DUE TO THE "EXPERIMENTAL" METAL & PEDICLE SCREWS "WITHOUT MY CONSENT OR KNOWLEDGE HAS GOT ME TO THE POINT, THAT TWO DRS HAVE TOLD MY IDENTICAL TWIN, I MUST NOT TRY TO GET ANYONE TO TAKE THE HARDWARE OUT, PLUS I NEED TO TAKE SOME TIME OUT TO TRY AND LEARN TO USE MY RIGHT SIDE, BEFORE THE LEFT SIDE GOES ON ME COMPLETELY AND TALK OF A WHEELCHAIR. I CAN PROVE EVERY WORK I WRITE, AND HLTH IS DOWN TO 5 LBS, AGE 75 LOOKS. MOVED DUE TO DR ORDERS NO STEPS, SWIMMING, CANNOT LIFT, REJECTING FOREIGN OBJECT SO BADLY, I HAVE TO LEAVE MY BRIDGE OUT OF MY MOUTH. AFRAID OF MEN IN MY LIFE SINCE FOUND OUT ABOUT METAL & PEDICLE, CAN'T EAT WELL AT ALL DUE TO CHOKING." "THIS IS MORE THAN ANY HUMAN BEING CAN BEAR, PAIN, CAN'T SLEEP AT NIGHT. ALL NIGHT IN MY SLEEP, WAKE UP NEXT MORNING WITH MARKS ALL IN MY FACE & NECK, I WOULDN'T WISH THIS ON MY WORST ENEMY, ALTHOUGH I HAVE BECOME PRETTY MUCH A RECLUSE IN MY HOME. I HAVE TO PAY PEOPLE TO HELP ME CLEAN, ETC. "I JUST GOT OUT OF THE HOSP A COUPLE WEEKS AGO. ALWAYS INFECTION AROUND THE FOREIGN OBJECT IN MY NECK. I HAD TO MOVE AGAIN, FOR FIRST FLOOR. DUE TO WEAKNESS IN LEFT LEG THAT GOES OUT AT LEAST TWICE A YR FROM THE EXPERIMENTAL SURGERY. FRACTURED MY ANKLE 6 MOS AGO, LEGS WENT OUT AGAIN. WAS IN HOSP AROUND THIS TIME LAST YR, METAL & PEDICLE SCREWS, WEIGHT LOSS, AFRAID TO EAT DUE TO CHOKING, 83 LBS. I'M 4.11 HEIGHT CANNOT GET THE WEIGHT SINCE LAST OF 1993 BECAUSE OF EXPERIMENT." "AGED 20 YRS-AT THE HOSP THIS PAST YR, I REALIZED I SHALL NEVER GOT BETTER FROM THE DAMAGE THE HLTH PROVIDER DID TO MY BODY. ITS SO HARD TO EXCEPT THE NEGLIGENCE, COLD CRUEL ACT, MALACE, THEY PERFORMED ON ME WITHOUT TELLING ME. I HAD CAME BACK HOME THAT AWFUL DAY THE NURSES CAME IN AND PUT UP X-RAYS AND SAID SHE WOULDN'T WANT MY NECK. I HAVE TRIED TO MAKE A COME BACK MANY TIMES, BUT THERES BEEN MANY NERVES, ARTERIES & MUSCLES DAMAGE DONE. ITS A NIGHTMARE. I GAVE UP A BOY FRIEND I HAD FOR 3 YRS AT THE AGE OF 58 YRS OLD HE WAS 31. I'VE ALWAYS BEEN AFRAID OF A MAN MY LIFE SINCE THEN. IT'S A SIN TO TREAT A HUMAN BEING LIKE AN ANIMAL WITHOUT TELLING THEM, I WOULD NEVER LET THE DR'S OR HOSP DO SOMETHING WITHOUT MY KNOWING. NOW FROM MIN TO MIN AND PRAY THE PAIN WILL GO AWAY. I'M JUST EXISTING. I HAVE TO HAVE NURSES IN OR 9 WEEKS LAST YR, THEN ITS BEEN MORE TO PAY TO COME AND HELP ME DO MY WASH & CLEANING. I STILL HAVE TO WEAR THE NECK BRACE PART OF THE TIME. I'VE BECAME A RECLUSE STAYING MOST OF THE TIME IN BED WITH PAIN. I MOVED NEAR 80 & 90 YR OLD PEOPLE TO SEE IF I COULD FEEL I BELONG IN THERE AGE GROUP. I TOLD MY IDENTICAL TWIN SISTER HER PAIN MAY BE FROM MY PAIN THESE PAST YRS THE DRS CANNOT FIGURE IT OUT UNLESS ITS COMING FROM MY PAIN.
HIGH PEAK PRESSURE ALARM GOING OFF ON VENTILATOR. PT CHECKED AND SUCTIONED, ALARM CONTINUED. VENT CHECKED AND TUBE THAT ACTIVATED EXHALATION VALVE FOUND TO BE DISCONNECTED, THIS TUBING IS BEHIND ACCESS COVER AND NOT IN PLAIN VIEW.
PT ON VENTILATOR FOR APPROXIMATELY 4 HOURS WHEN HE BECAME BLUE AND VITAL SIGNS DROPPED. PT ARRESTED. PT TAKEN OFF VENTILATOR, RESUSCITATED, PLACED BACK ON VENT. VENT SEEMED TO NOT ALLOW EXPIRATION. PT PLACED ON ANOTHER VENTILATOR. PROBLEM RESOLVED.
DURING A CODE BLUE SITUATION, THREE PACKAGES WERE OPENED AND ALL THREE RIPPED. PT OUTCOME WAS NOT ADVERSELY AFFECTED. AFTER THE CODE, A FOURTH PACKAGE WAS OPENED AND WAS ALSO FOUND TO BE DEFECTIVE.
C-WIRE WAS IMBEDDED IN CORONARY AFTER PROCEDURE. REQUIRED ADDITIONAL PROCEDURE TO REMOVE. SMALL PORTION OF WIRE REMAINS DISTALLY IMBEDDED.
PICC LINE INSERTED INTO PT. CATHETER LEAKED FROM SMALL HOLE. DEVICE INSERTED AND REMOVED ON 1/12/96. (*)
EVEN THOUGH THE PACKAGING LOOKS FINE RPTR CAN NOT BE SURE OF ITS STERILITY AND SAFETY. MERCHANDISE OUT OF DATE. (*) RPTR WAS CONTACTED BY MFR FOLLOWING SUBMISSION OF ORIGINAL REPORT. MFR STATED RPTR'S REQUEST WAS RECEIVED LATE. TO DATE, NO ONE FROM CO HAS COME TO PICK UP SYRINGES. SYRINGES WERE BOUGHT DIRECTLY FROM CO. RPTR WANTS CREDIT FOR THESE SYRINGES.
WHEN ATTEMPTING TO REMOVE CATHETER DURING SURGERY, THE CATHETER BROKE. THE DISTAL PORTION OF THE CATHETER REMAINS IN PT.
PT FOUND ON THE FLOOR NEXT TO THE BED WITH THE OXYGEN CANNULA TUBING AROUND HER NECK. THE PTS BED WAS FULLY LOWERED AND ALL 4 SIDE RAILS WERE UP. PT'S LEFT EAR WAS RED AND SWOLLEN, WITH A PURPLE MARK ON NECK. PT WAS CONFUSED.
AT THE CONCLUSION OF T+A WITH BILATERAL MYRINGOTOMY IT WAS NOTED THAT PT SUSTAINED A SMALL CHARRED AREA ON RIGHT SIDE OF LOWER LIP FROM ELECTROCAUTERY HANDSWITCHING PENCIL. THIS WAS OF MAJOR CONCERN AS THE TIP OF THIS PENCIL HAD NOT BEEN IN CONTACT WITH THE LIP. BIOMED ENGINEER EXAMINED EQUIPMENT AND NOTED SCORCHING ON BOTH THE PENCIL AND THE NEEDLEPOINT TIP. IT APPEARS THAT WHEN "THE TWO SCORTCHED AREAS ARE MATED THAT THE NEEDLE WAS NOT INSERTED TO THE STOPPING POINT IN THE PENCIL." INSERTION WAS HOWEVER NOTED TO BE DIFFICULT, POSSIBLY DUE TO A DEFECTIVE PENCIL.
SINCE THE INSTALLATION OF TWO NEW DEFIBRILLATORS IN 9/95, A SERIES OF INCIDENTS OCCURRED THAT HAVE RAISED CONCERNS REGARDING QUALITY CONTROL STANDARDS ON THE EQUIPMENT. BOTH DEFIBRILLATORS WERE DISCOVERED TO BE DEFAULTING TO 50 JOULES AT TURN ON WITH THE INTERNAL PADDLES CONNECTED. INITIAL TRAINING AND OPERATORS MANUAL INDICATES UNITS WOULD DEFAULT TO 10 JOULES AT TURN ON WITH THE INTERNAL PADDLES CONNECTED. THE UNITS WERE FOUND TO BE OPERATING ON VERSION "A" SOFTWARE AND NOT VERSION "D" SOFTWARE. VERSION "D" SOFTWARE HAD BEEN RELEASED IN 2/95 AND WOULD HAVE CORRECTED THE ISSUES. TWO REPLACEMENT UNITS WERE AIR FREIGHTED TO FACILITY. BOTH UNITS INDICATED FAULTS WHEN CHARGING. BOTH UNITS WERE FOUND TO BE PACING MODELS WHEN ORIGINAL PURCHASE WAS FOR NON-PACING MODELS. IN 10/95 A SECOND SET OF REPLACEMENT DEFIBRILLATORS WERE RECEIVED. IN 1/96 DURING AN URGENT DEVICE CORRECTIVE ACTION TO THE DEFIBRILLATORS BY HOSP'S BIOMED, ADDITIONAL PROBLEMS WERE IDENTIFIED. BOTH DEFIBRILLATORS WERE CHARGING TO 50 JOULES WITH INTERNAL PADDLES INSTALLED WHEN THE INSERVICE TRAINING AND OPERATORS MANUAL INDICATE THE UNITS WOULD DEFAULT TO A CHARGE OF ONLY 10 JOULES. THE INCORRECT SOFTWARE HAD BEEN INSTALLED BY CO. FOR ONE DEFIBERILLATOR, THE CORRECT SOFTWARE WAS SHIPPED BY OVERNIGHT EXPRESS AND INSTALLED 1/11/96. THE SECOND DEFIBRILLATOR HAD AN ADDITIONAL PROBLEM AND WAS RETURNED FOR REPAIR. ON THE SECOND DEFIBRILLATOR, THE PACEMAKER MODE COULD BE ACTIVATED BY MOVING THE FRONT PANEL SELECTOR SWITCH COUNTER CLOCKWISE. THIS MODEL SHOULD NOT BE EQUIPPED WITH PACEMAKER FUNCTIONS NOR IS THE SELECTOR SWITCH LABELLED WITH A PACEMAKER SELECTION. THE DEFIBRILLATOR WAS RETURNED TO CO FOR REPAIR AND A LOANER SUPPLIED. CO WILL ALSO INSTALL THE CORRECT SOFTWARE RELATED TO CHARGING CAPABILITIES.
CROSS-TALK BETWEEN TWO UNRELATED INTRA-CARDIAC ELECTROGRAM OUTPUTS CAUSING INCORRECT PERFORMANCE OF HEMODYNAMIC MONITORING SYSTEM DURING HEART CATHERIZARTION.
PT WAS WALKING AND FELT SOMETHING SNAP. RIGHT HIP BECAME VERY PAINFUL. PT'S RIGHT HIP PROSTHESIS THAT WAS PLACED IN 1987 SNAPPED. SURGERY WAS PERFORMED. PHYSICIAN WAS UNABLE TO REMOVE ENTIRE PROSTHESIS AND WAS UNABLE TO REPLACE HIP PROSTHESIS.
INFUSION PUMP MALFUNCTIONED DURING DELIVERY OF TPN SOLUTION. PUMP WAS PROGRAMMED TO TAPER UP OVER 1 HR PERIOD AND PERFORMED THIS FUNCTION FOR 3 1/2 HRS. NURSE STOPPED PUMP MOMENTARILY THEN REPROGRAMMED TO REMOVE TAPER UP SECTION BUT STARTED INFUSION AT CYCLE WITH TAPER-DOWN CYCLE INTACT. PUMP CHANGED FOR NEW ONE.
DISPOSABLE TEMPERATURE PROBE COVERS WERE NOTED TO CARRY A POWDERY SUBSTANCE ON THE OUTSIDE AND INSIDE OF THE PROBE COVERS. RANDOM SAMPLING OF PRODUCT OF SAME LOT # ALSO WERE DEFECTIVE.
SIX-YR-OLD WITH ADULT RESPIRATORY DISTRESS SYNDROME REQUIRING MECHANICAL VENTILATION, HIGH FIO2 AND PEEP. THE CHILD'S OXYGEN SATURATION WENT FROM 92% TO 100% AFTER CHEST TUBE INSERTION. HE WAS WEANED TO 60% FIO2. BLOOD GASES SHOWED PAO2=31MMHG WITH O2 SAT=61%. THE CHILD'S PULSE OXIMETER CABLE WAS NOTED TO BE WET AT THE SENSOR CONNECTION CAUSING A SHORT. AFTER DRYING, PULSE OXIMETER MONITOR CORRELATED WITH PAO2. HOSP HAS REPRODUCED THIS PHENOMENA BY WETTING THE OXIMETER TO CABLE INTERFACE WITH SALINE SOLUTION. THE OXYGEN SATURATIONS INCREASE SIGNIFICANTLY AND RETURN TO BASELINE AFTER DRYING UTILIZING CO'S DISPOSABLE.
WHILE PERFORMING LASER LAPAROSCOPY IT WAS NOTICED THAT TIP OF ROUNDED LASER PROBE HAD BROKEN OFF. STERILE FIELD AND SURROUNDING AREA SEARCHED. UNABLE TO LOCATE LASER TIP. THE MD IS AWARE. THE PROBE TIP CRYSTAL IS NOT X-RAY DETECTIBLE, NOT EVEN SURE IF IT VAPORIZED.
RPTR C/O JOINT PAIN, FATIGUE, MEMORY LOSS, LUPUS, MENTAL STRESS, DIZZINESS, AND SMALL STROKES.
QUICKIE DESIGNS, INC. 2842 BUSINESS PARK AVE. FRESNO, CA 93727-1328. INVESTIGATION OF THIS PARTICULAR REPORT HAS DETERMINED THE FOLLOWING: 1. OPERATOR OF DEVICE WAS GIVEN AMPLE TIME AND INSTRUCTION PRIOR TO PURCHASE. 2. OPERATORS MEDICAL HISTORY, (MS), HAS AND IS AN ISSUE WITH THE PROPER OPERATION OF THE DEVICE. 3. OPERATOR, AND ATTENDANT, HAVE MADE MODIFICATIONS TO DEVICE WITHOUT FULLY UNDERSTANDING END RESULTS. 4. CURRENTLY WORKING WITH DEALERSHIP AND OPERATOR OF DEVICE TO DETERMINE APPROPRIATE CONCLUSION.
THE GEL IS CONTAINED IN SYRINGE SYSTEM WITH A REPLACEABLE STERILE TIP. AS THE DENTIST WAS INSERTING THE CONDITIONER, THE TIP SEPARATED AND FELL INTO THE PT'S MOUTH. PT WENT TO THE ER AND REQUIRED A BRONCHOSCOPY TO RETRIEVE THE TIP.
LASER BURNING "ANTERIOR TO TARGET." MD TRIED SEVERAL ADJUSTMENTS. DR GIVENLITERATURE FROM CO ON APPROPRIATE SETTINGS AND HE IS STILL EXPERIENCING DIFFICULTY. CO CALLED TO SVC MACHINE. MD DID NOT WANT TO SPEAK TO CO SVC DEPT. MDR WAS GIVEN 1-800#. PT NEEDED TO BE DILATED TO COMPLETE PROCEDURE.
THREE YEARS AGO RPTR HAD A PACEMAKER AND LEAD IMPLANTED. THE DAY AFTER INSERTION PHYSICIAN WENT IN TO TIGHTEN A WIRE. THE NEXT DAY A SCREW WAS TIGHTENED. IN AUGUST RPTR HAD A WIRE REMOVED. FOR 3 YEARS RPTR'S BLOOD PRESSURE WAS 250/170 THE MINUTE SHE GOT OUT OF BED AFTER A NIGHT OF REST AND SLEEP. RPTR BELIEVED THE DEVICE STOPPED WORKING WHEN SHE WAS LYING DOWN. SHE HAD SERIOUS BREATHING RPOBLEMS. ECHOCARDIOGRAMS ARE PERFECT. RPTR HAS NEVER BEEN SICK OR HAD SURGERY.
ON 3/8/93 BONE GRAFT WITH METAL INSTRUMENTS REMOVED. ON 2/6/92 METAL INSTRUMENT PLACED IN RPTR'S BACK. A LOT OF PAIN STILL PERSISTS. TWO OF THE SCREWS WERE BROKEN. RPTR HAS CONSTANT BACK PAIN AND PAIN IN BOTH LEGS AND FEET. FEET BURN. RPTR CAN'T STAND OVER 10 MINUTES IN ONE PLACE. RPTR GETS NO SLEEP AT NIGHT. (*)
MINIMED TECHNOLOGIES, 12744 SAN FERNANDO RD, SYLMAR, CA 91342. THE REPORT HAD NO INDICATION OF TEH SERIAL NUMBER OF THE MODEL 504S INSULIN PUMP. LOT NUMBER OF THE INFUSION SET, ADDRESS OR NAME OF THE PT, NOR THE NAME OF NAY HEALTH PROFESSIONAL. THEREFORE, A COMPLETE EVALUATION OF THE SPECIFIC EVENT CANNOT BE PERFORMED. BECAUSE WE HAVE NO RECORD OF THIS COMPLAINT OR THE DEVICE, NO ANALYSIS IS AVAILABLE.
CONSUMER STARTED USING BOTH PRODUCTS IN JULY OF 1991. ACCORDING TO RPTR, THE IV SET DELIVERED ONLY HALF OF THE INSULIN DOSE IN OCTOBER OF 1991, CAUSING HER TO HAVE DKA. HER BLOOD GLUCOSE WAS 497. THIS EPISODE OF DKA CAUSED HER TO HAVE A STROKE, WHICH WAS DIAGNOSED BY MRI, AND SUBSEQUENT MEMORY LOSS. SHE HAD COPIOUS AMOUNTS OF KETONE IN HER BLOOD. RPTR CONTINUED TO EXPERIENCE FAILURE OF THE PUMP WHICH WAS REPLACED 7 TIMES BY THE MFR. THE LAST PROBLEM RPTR HAD WAS IN JANUARY OF 1996, WHEN THE PUMP WENT COMPLETELY BLANK. THE RPTR TRIED TROUBLESHOOTING AS DIRECTED BY THE MFR'S REP, HOWEVER, NOTHING WORKED. SHE WAS TOLD BY THE REP THAT THE CAUSE OF FAILURE COULD BE ELECTROSTATIC MALFUNCTION. THREE DAYS LATER, WHEN THE PUMP WAS SITTING IN THE BATHROOM, IT CAME BACK ON. RPTR IS VERY CONCERNED THAT THE PUMP MIGHT FAIL ANY TIME. IT IS ALSO OUT OF WARRANTY. (ALSO SEE 1008220)
IN JAN 1986 RPTR HAD A HERNIA REPAIR AFTER HAVING A C-SECTION. THE DOCTOR USED WIRE SUTURES. IN MAY OF 1995 RPTR DEVELOPED SEVERE ABDOMINAL PAIN. THE DOCTOR DID TESTS AND FOUND OUT THE WIRE SUTURES HAD BROKEN AND SCATTERED IN HER ABDOMEN. SINCE THEN SHE HAS DEVELOPED COMPLICATIONS AS A RESULT OF THE REMOVAL OF THE BROKEN WIRE SUTURES. RPTR HAD SEROMA POCKETS. THE ONLY WAY TO TREAT THEM IS TO HAVE THE WOUND OPENED TO HEAL. AS A RESULT IT IS CAUSING RPTR PAIN AND SUFFERING.
RPTR HAD MAMMARY IMPLANTS FOR COSMETIC REASONS. HCP HAS CONFIRMED SILICONE OUTSIDE THE SCAR TISSUE CAPSULE. SHE HAD CALCIUM DEPOSITS. SHE HAD NUMBNESS, HEMATOMA, EXCESS FLUID AND INFECTION IN THE SURGICAL AREA. IMPLANTS WERE RUPTURED AND SHE HAD BLEEDING THROUGH THE ENVELOPE, CAPSULAR CONTRACTURES AND OPEN CAPSULOTOMIES OF BOTH BREASTS. RPTR C/O: BLADDER INFECTIONS, INTESTINAL CYSTITIS, LOW BLOOD PRESSURE, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, CARPAL TUNNEL SYNDROME, MOTOR NEURON DISEASE, BRAIN LESIONS, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, DEMENTIA, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ATYPICAL M-S, ORGANIC BRAIN SYNDROME, REDUCED BLOOD FLOW TO BRAIN, BRAIN TUMOR, PAIN AND/OR BURNING SENSATION IN CHEST, ELEVATED CHOLESTEROL OR TRIGLYCERIDES, RAPID DETERIORATION OF EYES, VISION LOSS, THYROID PROBLEMS, ADRENAL PROBLEMS, CHRONIC SWELLING, PAIN, DISCOLORATION OF EXTREMITIES, HEAT OR COLD SENSITIVITY, RAYNAUD'S DISEASE, FREQUENT LOW GRADE FEVER, CONSTIPATION, ESOPHAGITIS, DUODENTITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME, INFERTILITY, MISCARRIAGE &/OR STILLBIRTH, CLASS IV CANCER, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, FREQUENT MIGRAINES/SEVERE HEADACHES, HEART PROBLEMS, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, ATYPICAL LUPUS, SJOGREN'S SYNDROME, SCLERODERMA, ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, ACUTE BRONCHITIS, ASTHMA, MARKED EDEMA/RESPIRATORY DISTRESS, RIGHT LUNG "SCOLOSIS" SYNDROME, CHRONIC SWOLLEN LYMPH NODES, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, MYOSITIS OR POLYMYOSITIS, FASCITIS, DEMYELINIZATION OF MUSCLE NERVES, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, DERMATOMYOSITIS, CHRONIC INSOMNIA, VASCULITIS, THORACIC OUTLET SYNDROME, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS, MISJUDGES DISTANCE, SICCA, AND CALCIUM DEPOSITS.
RESIDENT WAS FOUND IN ROOM WITH HEAD ON BED AND BODY THROUGH SIDERAILS OF BED. RESIDENT WAS COOL AND CYANOTIC. RESIDENT WAS REMOVED FROM SIDERAILS AND WAS FOUND TO HAVE NO RESPIRATIONS AND A WEAK PULSE. EMTS WERE ON THE SCENE IMMEDIATELY AND BEGAN A CODE WITH RETURN OF RESPIRATIONS AND RESIDENT WAS TRANSPORTED TO THE ER. RESIDENT WAS EVALUATED AT THE HOSP AND PLACED ON A RESPIRATOR, AND PT IS BEING WEANED FROM THIS. STAFF WAS IN RESIDENT'S ROOM 10 MINUTES PRIOR TO INCIDENT. HOSP PHYSICIAN FEELS THAT RESPIRATORY ARREST IS RELATED TO CAUSE WHICH IS UNCLEAR AT PRESENT. SIDERAILS WERE PADDED AND RESIDENT WAS CHECKED 10 MINUTES PRIOR TO INCIDENT. (*)
MFR'S AD SAYS "IMMEDIATE PAIN RELIEF WITHOUT DRUGS." THE AD WAS TAKEN FROM PREVENTION MAGAZINE. (JANUARY ISSUE). RPTR WANTS THE FDA TO ENFORCE THE 1976 DEVICE ACT AGAINST THE STIMULATOR AND TAKE IT OFF THE MARKET. THE CO IS MAKING FALSE CLAIMS REGARDING THIS DEVICE. RPTR'S UNDERSTANDING IS THAT THE FDA CONFISCATED 16000 OF THE STIMULATORS. (*)
RPTR C/O NUMBNESS IN RIGHT BREAST, PAIN, SMALL HEMORRHAGES UNDER SKIN STARTING 1980 AND GETTING PROGRESSIVELY WORSE, FATIGUE, 1989 - SWOLLEN LYMPH NODES IN NECK, SWOLLEN, SORE SALIVARY GLANDS. RIGHT NECK AND JAW MUSCLE SPASMS, 1993 CARPAL TUNNEL SYNDROME - RIGHT HAND. CARPAL TUNNEL RELEASE 1994. SHE NOW HAS THENAR ATROPHY RIGHT HAND AND UNABLE TO USE IT WITHOUT PAIN. 1995 MUSCLE WEAKNESS BECOMING WORSE IN BOTH ARMS AND VISUAL DISTURBANCES. SHE HAS BEEN A NURSE FOR 18 YEARS. SHE FEELS SHE IS BEING SLOWLY POISONED. SHE IS VERY UPSET WITH THE LACK OF CONCERN FROM FDA AND THE MEDICAL COMMUNITY. NOBODY SEEMS TO CARE AT ALL. (*)
RPTR'S FACILITY HAS A GLUCOSE METER FOR USE IN THE NURSERY SETTING. THEY WERE UNABLE TO GET CONSISTENT, RELIABLE READINGS FROM THE GLUCOMETER IN THE NURSERY SETTING; THE VALUES WOULD NOT CORRELATE WELL WITH THE CLINICAL CHEMISTRY ANALYZER. DOCUMENTATION OF PROBLEMS STARTED TO ARRIVE IN THE LAB IN 2/95 OF LOW GLUCOSE VALUES IN THE NURSERY. LAB GLUCOSE VALUES WERE CONSISTENTLY HIGHER THAN ON THOSE SPECIMEN VALUES OBTAINED IN THE NURSERY. DOCUMENTATION KEPT ARRIVING IN THE LAB UNTIL IN APRIL WHEN THE DECISION WAS MADE TO PERFORM A CORRELATION STUDY USING THE GLUCOSE METER AND THE ANALYZER IN THE LAB. THEY CORRELATED FAIRLY WELL. HOWEVER, THE PROBLEM REMAINED THAT WHEN IN USE WITH NORMAL INFANTS THEY CONTINUED TO GET CONFLICTING RESULTS, ESPECIALLY WHEN THE VALUES WERE IN THE LOWER END OF NORMAL. (*)
CATHETER COMPLETELY DISLODGED FROM HOUSING AND PASSED INTO PULMONARY VESSEL. CATHETER WAS INSERTED ON 1/17/96 WITH GOOD POST-OP CHEST X-RAYS. ONCOLOGIST TRIED TO USE IT ON 1/26/96 WITHOUT SUCCESS. CHEST X-RAY DONE AT THAT TIME DEMONSTRATING CATHETER DISLODGED INTO PULMONARY VESSELS. THE PROBLEM WITH THIS NEW TYPE OF CONNECTOR IS THAT IT DOES NOT STAY LOCKED.
PT EXPERIENCED FLUSHING OF FACE AFTER INFUSION OF TIMENTIN 3.1 GM IV VIA MIDLINE CATHETER. FLUSHING OCCURRED APPROX 1/2 HOUR POST INFUSION AND LASTED "A FEW MINUTES." PT'S CATHETER WAS PULLED 1/22/96 AND ANOTHER CATHETER WAS INSERTED (SAME MFR, BOTH CATHETERS MADE OF SAME MATERIAL AND FLUSHING STILL OCCURRED.
EXTRA-CORPOREAL MEMBRANE OXYGENATION PUMP STOPPED FUNCTIONING. MANUAL ROTATION WAS STARTED AS THE PROBLEM WAS IDENTIFIED. A NEW PUMP WAS BROUGHT TO THE BEDSIDE AND PUT INTO USE. OXYGEN SATURATIONS DROPPED INITIALLY AND THEN RETURNED TO NORMAL AS THE PROBLEM WAS CORRECTED. BIOMEDICAL ENGINEERING OPENED THE PUMP AND FOUND THAT THE BELT HAD COMPLETELY SPLIT APART. ACCORDING TO THE PT'S ATTENDING PHYSICIAN, THE PT WAS NOT COMPROMISED BY THIS OCCURRENCE. ALL APPROPRIATE PREVENTATIVE MAINTENANCE HAD BEEN DONE ON PUMP. BELT WAS WELL WITHIN NORMAL USAGE TIME, SO IT SHOULD NOT HAVE SPLIT.
DIAGNOSIS OF DUCTAL INFILTRATING BREAST. SHE HAD A RIGHT MASTECTOMY WITH IMMEDIATE RECONSTRUCTION ON 1/9/95 WITH TISSUE EXPANDER WITHOUT DIFFICULTY OR PROBLEMS. 8/22/95 REMOVAL OF RIGHT BREAST TISSUE EXPANDER AND INSERTION OF PERMANENT SALINE BREAST IMPLANT. 11/15/95 I&D OF RIGHT BREAST WITH CULTURES. 11/17/95 REMOVAL AND DRAINING INFECTED RIGHT BREAST IMPLANT.
WHILE PREPARING STERILE RPODUCTS IN A LAMINAR FLOW HOOD, RPTR REACHED FOR A 5CC SYRINGE AND WAS STUCK BY THE NEEDLE WHILE THE NEEDLE WAS STILL IN THE OUTERWRAP. NO SYRINGE CAP WAS IN PLACE TO SHIELD THE NEEDLE. NO SERIOUS INJURY OCCURRED AND NO OTHER SYRINGES IN THE SAME BOX WERE FOUND WITHOUT A SHIELD.
SCREW BROKE OFF IN BONE. PT WAS UNAFFECTED.
PT WAS HAVING ORIF OF DISTAL LEFT HUMERUS FRACTURE. A 4.0 CANCELLOUS PARTIALLY-THREADED 40MM SCREW BROKE AT END OF THREADS. THREADED PORTION REMAINS IN BONE. FRACTURE WAS STILL ABLE TO BE REDUCED WELL.
LATEX-FREE SURGEON'S GLOVES DURING SURGERY, WHEN BONE CEMENT TOUCHED THE LATEX-FREE SURGEON'S GLOVES, THEY DISINTEGRATED. WHILE CO STATES THAT PACKAGE INSERT ADDRESSES THIS WITH A WARNING, HOSP STAFF UNABLE TO FIND SUCH INSERT IN GLOVE BOX. ALSO, INDIVIDUAL GLOVES SHOULD BE MARKED BUT ARE NOT AND BOX SHOULD BE MARKED AND IS NOT. (*)
THREE FRENCH PICC LINE INSERTED INTO RIGHT BASILIC VEIN. GUIDE WIRE REMOVED AND LINE FLUSHED WITH 5CC NS. LEAKING WAS NOTED AT CATHETER HUB. LINE HAD TO BE REMOVED. A SMALL HOLE IN THE CATHETER WAS NOTED. RPTR HAS HAD THIS PROBLEM OCCUR ON 3-4 DIFFERENT OCCASIONS WITH THIS PRODUCT.
RPTR HAD BREAST IMPLANTS IMPLANTED IN 1975. SHE HAS BEEN SEEING A DOCTOR SINCE 1977, SHE WAS DIAGNOSED WITH SLE IN 1992. SHE IS ON DISABILITY FOR LUPUS AND MS SYMPTOMS.
RPTR FINDS THAT CONICAL MEDICATION CUPS ARE NOT ACCURATE. THEY ARE OK FOR NON-SIGNIFICANT MEDICATIONS BUT HAVE A VARIED MARGIN OF ERROR FOR SIGNIFICANT MEDICATIONS - EITHER TOO LITTLE OR TOO MUCH. VARYING DEGREES OF OPACITY AND GRADUATION (FINE) OR (COARSE) ARE CONTRIBUTING FACTORS. RPTR SUGGESTS CYLINDRICAL MEASURING DEVICES FOR SIGNIFICANT MEASURES.
SURGERY NURSE RETURNED BOX TO PHARMACY ON 12/6/95 BECAUSE THE UNIT CAME WITHOUT A CANNULA.
COMPLAINANT WANTED TO ALERT THE AGENCY TO SERIOUS PROBLEMS ASSOCIATED WITH A MEDICAL DEVICE. HE REPORTED THE FOLLOWING: DEVICE IS A PIECE OF JUNK AND LABS ARE BEING SUCKERED INTO PURCHASING BY SALES REPS AT A COST OF $35,000-$28,000. DEVICE FREQUENTLY BREAKS DOWN. DEVICE FREQUENTLY REPORTS FALSE NEGATIVES OR FALSE POSITIVES. SVC PEOPLE ARE NOT TRAINED PROPERLY, TRAINING INVOLVES A 20 MIN VIDEO TAPE. FIRM DOES NOT FOLLOW GMP'S. NO 510K APPROVAL FOR DEVICE. TURN-OVER OF EMPLOYEES IS HIGH, CAN'T KEEP GOOD PEOPLE. COMPLAINANT PROVIDED TWO USERS WHO WOULD CONFIRM EXPERIENCING SERIOUS PROBLEMS WITH THE DEVICE.
DEVICE IS USED IN CATARACT SURGERY TO MAINTAIN THE EYE. IT IS A DEVICE THAT IS INJECTED INTO THE EYE. THE PHYSICIAN REPORTED THAT AFTER THE PRODUCT WAS INJECTED INTO THE EYE HE SAW METAL SHAVINGS THAT HE ATTRIBUTES TO THE CANNULA OF THE DEVICE. THE PHYSICIAN EXTRACTED THE PARTICLE IN QUESTION FROM THE EYE AND PLACED IT ON A SPONGE. THIS SPONGE AND THE REMAINS OF THE PRODUCT HAVE BEEN SENT TO AN INDEPENDENT LAB FOR TESTING. THIS EVENT WAS REPORTED TO THE MFR.
SINCE APPROXIMATELY JULY OF 1993, RPTR HAS BEEN IN EVER-INCREASING PAIN. SINCE 1993, RPTR HAS BEEN UNDER TREATMENT AT A PAIN MANAGEMENT CLINIC. RPTR HAS HAD THREE PHENOL BLOCKS ADMINISTERED DURING THIS TIME. ALL WERE SUCCESSFUL, BUT ONLY FOR PERIODS UP TO THREE MONTHS. RPTR HAS ASKED FOR A FOURTH, BUT ONLY AFTER THE REMOVAL OF THE FIXATION DEVICE, WILL THE DOCTOR CONSIDER IT. HE HAS BEEN ON TYLENOL FOUR SINCE 1993, TAKING SIX PER DAY. HE NOW FINDS HIMSELF ADDICTED TO THIS DRUG. ON 3/2/94, A MYELOGRAM WAS DONE AT THE REQUEST OF A PHYSICIAN. RPTR HAD ASKED HIM TO REMOVE THIS DEVICE. HE WOULD NOT. IN 1989 WHEN THE FIRST DEVICE WAS IMPLANTED NO DOCTOR IN RPTR'S CITY USED IT. THE REPORT ON THE MYELOGRAM OF 3/2/94 STATED: "MOTTLED DENSITY OF THE L2 VERTEBRAL BODY OF UNCERTAIN ORIGIN. I CANNOT EXCLUDE A SLOW NEOPLASTIC INFILTRATION BUT SUGGEST CLINICAL CORRELATION." THIS DID NOT SEEM TO BOTHER THE DOCTOR, BUT IT SURE BOTHERS RPTR. ON 1/1/94, HE WEIGHED 171 POUNDS. HE PRESENTLY WEIGHS 148 POUNDS. IT HAS NOTHING TO DO WITH HIS CLL. BOTH HIS ONCOLOGIST AND PAIN MANAGEMENT SPECIALIST HAVE STATED IT IS THEIR BELIEF THAT NO RELIEF FROM THE PAIN AND WEIGHT LOSS (SLEEP DEPRIVATION), WILL BE HAD UNTIL THIS USELESS, (THEIR WORDS), DEVICE IS REMOVED. AFTER ALL, BACK IN 1993, THE DOCTOR STATED THAT THE DEVICE WOULD REMAIN, ONLY LONG ENOUGH FOR THE FUSION TO TAKE HOLD. IT HAS, AND CONTRARY TO ALL BELIEFS, RPTR IS NOT STEROID DEPENDENT. THERE IS NOW, AS IN 1993 WHEN HE WAS SOLD A BILL OF GOODS, ABSOLUTELY NOTHING WRONG WITH HIS BODY'S ABILITY TO FUSE. NOW HE WANTS THIS REMOVED POST HASTE.
TUBING ON THE FEMALE DISTAL END OF 1.2 MICRON FILTER SET IS KINKED, PREVENTING PRIMING PROCESS OF TPN SOLUTION.
WHILE ATTEMPTING PORT INSERTION, THE J GUIDE WIRE SHREDDED AND BROKE APART. ALL STRAY FRAGMENTS WERE RETRIEVED WHILE WITHDRAWING THE INTRODUCER UNDER FLUOROSCOPY.
A MILD BURN WAS NOTED ON ABDOMINAL AREA FOLLOWING OUTPATIENT SURGERY (LEEP PROCEDURE). PATIENT WAS EXAMINED AND TREATED. SILVADENE CREAM APPLIED TOPICALLY.
A MILD BURN WAS NOTED ON ABDOMINAL AREA FOLLOWING OUTPATIENT SURGERY (LEEP PROCEDURE). PT WAS EXAMINED AND TREATED. SILVADENE CREAM APPLIED TOPICALLY.
DURING THERAPY REGIMEN, RIGHT HAND WAS DIPPED IN PARAFFIN AND WRAPPED FOR 15 MINUTES. THE PT RETURNED FOR THERAPY THE NEXT DAY WITH A DIME-SIZED BLISTER WHICH APPEARED TO BE A BURN ON THE RIGHT FINGER.
DURING PHYSICAL THERAPY THE PT SUSTAINED A SMALL BURN ON THE DORSUM OF THE RIGHT FOOT WITH THE USE OF THE DISPERSIVE PAD ON THE MACHINE. SILVADENE APPLIED.
WHILE PERFORMING VITRECTOMY, EYE PRESSURE DROPPED DUE TO THE FOOT SWITCH ON THE VITRECTOMY MACHINE WHICH BECAME MECHANICALLY STUCK IN THE "ON" POSITION. FOOT SWITCH WAS DISCONNECTED AND EYE PRESSURE INCREASED USING THE FRONT PANEL CONTROLS.
VENTILATOR CEASED FUNCTIONING, VENT "INOP" ALARM SOUNDED. NURSES IMMEDIATELY DISCONNECTED VENTILATOR AND MANUALLY VENTILATED PT. VENTILATOR WAS REMOVED AND REPLACED. PT ASSESSMENT REVEALED NO ADVERSE CONSEQUENCES TO PT CONDITION.
DEVICE WAS BEING USED TO CLOSE TROCAR SITE AT UMBLICUS. DEVICE BROKE IN THE INCISION. IT TOOK 3 X-RAYS AND 1 HR, 40 MIN ADDITIONAL OR TIME TO RETRIEVE BROKEN PART. NO FURTHER COMPLICATIONS.
DISPOSABLE HOT BIOPSY FORCEPS USED ONE TIME. WHEN ATTEMPTING TO CAUTERIZE A POLYP #2, IT WAS NOTED THAT ONE SIDE OF FORCEPS (A CUP) WAS MISSING. BROKEN PIECES RETRIEVED. COAG SETTING OF 4 USED; ALL PIECES RETRIEVED.
DURING A LAPAROSCOPIC CHOLESTECTOMY PROCEDURE, WHEN SURGEON TRIED TO USE DEVICE, THE UNIT JAMMED WITH ALL THE STAPLES IN. ALTERNATE DEVICE HAD TO BE USED.
PT WAS ON MACHINE FOR TREATMENT APPROX 2 HRS. MACHINE STOPPED AFTER ALARMING "BLOOD PUMP IN WRONG POSITION." MACHINE WOULDN'T RESET. TECHNICIAN TRIED TO RETURN PT'S BLOOD BACK INTO PT. AFTER A COUPLE OF ATTEMPTS, CARTRIDGE BURST.
AFTER FIRING STAPLER, CLEAR PIECE WITH NUMBER FELL OFF OF THE SIDE OF UNIT. SURGEON LOCATED THE MISSING PIECE AND RETRIEVED FROM INSIDE OPERATIVE FIELD (ABDOMEN).
PT WAS ADMITTED TO OUTPATIENT SURGERY FOR MICROTRACHEOSTOMY. PRODUCT WAS NOT ABLE TO BE INSERTED WITH TWO ATTEMPTS (TWO DIFFERENT SETS USED).
PENILE IMPLANT PROCEDURE WAS COMPLETED ON 2/12/90. THREE YEARS LATER IMPLANT DEVELOPED A LEAK. IMPLANT WAS EXPLANTED AND REPLACED ON 1/3/96 WITH NO FURTHER PROBLEMS.
CRITICAL CARE PT UNDERGOING CONTINUOUS MONITORING. ICP WAVE FORMS ON MONITOR NOTED TO BE FLAT. MONITOR CHECKED. BP READING NOTED ON SCREEN ONLY.
PTCA PROCEDURE IN PROGRESS. WHILE ATTEMPTING STENT DEPLOYMENT, STENT WOULD NOT PASS TO TARGET. UPON REMOVAL OF DEPLOYMENT CATHETER, STENT WAS NOT ATTACHED. ATTEMPTS TO LOCATE STENT NOT SUCCESSFUL.
A NUMBER OF THERMOMETERS WERE FOUND NOT TO WORK WHEN TAKEN OUT OF THE PACKAGE. A FEW DO NOT TURN OFF AFTER BEING TURNED ON.
PT UNDERWENT UNCOMPLICATED CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. FOLDABLE ACRYLIC LENS INSERTED. "CREASE" NOTED IN IOL ALONG THE FOLD LINE POSTOPERATIVELY. MILD INTERFERENCE WITH VISION DUE TO OPACITY/DEFECT IN IOL (BEST CORRECTED 20/25).
CHIP BROKE OFF THE END OF TROCAR. UNABLE TO FIND CHIP IN PT. UNABLE TO DETERMINE IF TROCAR WAS CHIPPED PRIOR TO INSERTION.
IABP ALARMED. THERE WERE 2 LARGE HELIUM LEAKS. UNABLE TO RESET AND START PUMP FOR 3-5 MIN. SWITCHED TO ANOTHER PUMP WITH NO FURTHER PROBLEMS. PT'S BP DECREASED DURING PUMP MALFUNCTION. PUMP REPAIRED BY MFR AFTER BEING REMOVED FROM SVC.
EPIDURAL CATHETER WAS INSERTED IN LABORING OB PATIENT WITHOUT DIFFICULTY. WHEN CATHETER WAS REMOVED, IT BROKE, LEAVING APPROXIMATELY 12 CM. BOTH CATHETER AND WIRE REMAIN EMBEDDED IN PATIENT. PATIENT SUFFERED NO ADVERSE CONSEQUENCES. RECOMMENDATION FROM SEVERAL ANESTHESIOLOGISTS IS TO LEAVE THE PIECE OF DEVICE WHERE IT IS.
SECONDARY MEDICATION BACKED UP INTO PRIMARY IV SOLUTION BAG. THIS OCCURRED IN TWO IV SETUPS USING TUBING WITH SAME LOT NUMBER DESPITE SECONDARY MEDICATION BEING ELEVATED ABOVE PRIMARY INFUSION. IV INFUSION PUMP ALSO USED.
DURING CANNULATION, IT WAS NOTICED THAT CANNULA WAS CRACKED NEAR THE CONNECTION TO THE CARDIOPULMONARY TUBING. THE LINE CLAMP WAS CLOSED.
CLIP APPLIER DOES NOT WORK WHEN FIRED. WOULD NOT FORM CLIPS AT TIMES.
WHEN THE DEVICE WAS OPENED, THE MASK WAS MISSING AND THEY COULD NOT USE THE DEVICE.
THE FOLDABLE ACRYLIC IOL WAS PLACED INTO THE EYE. THE LENS HAD CRACKED IN HALF. THE 2 PIECES WERE REMOVED. THE LENS WAS REPLACED BY AN OLDER STIFF 5.0 MM PMMA LENS. THE PT HAS DONE FINE. HOWEVER, A SIMILAR LENS HAD A SMALL CRACK IN IT AND RPTR REMOVED IT AS WELL. HE WILL NOT USE THIS LENS AGAIN. HE SPOKE WITH ANOTHER OPHTHALMOLOGIST WHO HAD A SIMILAR ACCOUNT. PT WILL NOT USE THE LENS AGAIN EITHER. THE CO DENIES SUCH PROBLEMS EXIST.
PTCA IN PROGRESS. DURING INSERTION/INFLATION OF BALLOON CATHETER, THE BALLOON RUPTURED. BALLOON REMOVED. STENTS PLACED. PROCEDURE COMPLETED.
ANTERIOR LEFT FOOT FOUND TO BE EXCORIATED UNDER SENSOR. PROBE REPLACED WITH ANOTHER MODEL ON RIGHT FOOT.
WHILE THE ORTHOPEDIC SURGEON WAS SUTURING THE PT'S LEFT ROTATOR CUFF DURING A LEFT ROTATOR CUFF REPAIR, THE VERY TIP OF THE SUTURING NEEDLE BROKE OFF. THE WOUND WAS IRRIGATED WITH SALINE SOLUTION, AND AN X-RAY OF THE LEFT SHOULDER WAS NEGATIVE FOR A FOREIGN BODY.
SKIN SLOUGH OF GLABELLA FOLLOWING COLLAGEN INJECTION.
WHILE EXPELLING AIR FROM LOW PRESSURE SYRINGE WITH INJECTOR, SYRINGE END EXPLODED OFF IN 2 PIECES, DUE TO INJECTOR PRESSURE. NO INJURY TO PT, OPERATOR OR EQUIPMENT. ERROR CODE ON THE INJECTOR REGISTERED E439. USER WAS INSTRUCTED TO CALL CO SERVICE NUMBER.
THREADS ON JIG ADAPTOR FROM FEMORAL NAIL SYSTEM BROKE WHILE ATTACHED TO FEMORAL NAIL.
NEEDLE ASSEMBLY CLOGGED (BLOCKED OR RESTRICTED) THUS LIMITING FLOW AND CAUSING AMBULATORY PUMPS TO ALARM WITH OCCLUSION.
TWO TUBINGS WERE PRIMED FOR ADMINISTRATION OF IV THERAPY. BOTH TUBINGS LEAKED FROM 1ST PIGGYBACK JUNCTION. ONE TUBING RETURNED TO MFR AND THE OTHER WAS DISPOSED OF.
PT ON A VENTILATOR. THIS DEVICE IS NEW WITH 64.49 HOURS ON INDICATOR. THE DEVICE BEGAN TO ALARM, SO PT WAS TAKEN OFF AND MANUALLY VENTILATED. A RESPIRATORY TECH ATTEMPTED TO VENTILATE THE PT. IT WAS THEN NOTED THAT THE VENT WAS NOT EXPIRING AND THE OVERPRESSURE ALARM WOULD SOUND BY THE SECOND INSPIRATION. THE PT WAS PLACED ON ANOTHER VENTILATOR WITHOUT INCIDENT. THE SUSPECT VENT WAS BROUGHT TO BIOMED WHERE IT WAS CONNECTED TO A TEST LUNG. THE PROBLEM WAS DUPLICATED IN BIOMEDICAL ENGINEERING.
EXTENSION SET WOULD NOT FLUSH, APPEARS TO HAVE DEFECT/BLOCKAGE. WAS NEVER ATTACHED TO PT.
LEVOPHED DRIP WAS BEING ADMINISTERED TO PT USING INFUSION PUMP. PT'S BLOOD PRESSURE WAS NOT IMPROVING EVEN WITH MEDICATION DESCRIBED. NURSE NOTICED THAT A FLUID WAS COMING OUT OF PUMP ONTO FLOOR. THE NURSE DETERMINED THAT WHEN LOADING THE SET, THE TUBING WAS CUT BY THE TUBE PINCHER AT THE FREE FLOW PROTECTION CLIP. THIS CUT RESULTED IN THE LEAKING OF THE MEDICATION. HOSP BIO-MED PERSONNEL DUPLICATED THE PROBLEM AND HAVE ISOLATED PUMP UNTIL REPAIR COMPLETED.
RPTR RECEIVED DOUBLE LUMEN BREAST IMPLANTS AND BECAME ILL APPROX 1 YR LATER. RPTR HAD IMPLANTS REMOVED 6 YEARS LATER AFTER SHE RECEIVED NO ANSWERS REGARDING ALL HER ILLNESSES. BOTH IMPLANTS WERE RUPTURED OR LEAKING. SOME OF THE ILLNESSES ARE IMPROVING SLOWLY.
THORACENTESIS TRAY-NEEDLE PROTECTOR DIDN'T LOCK DURING PROCEDURE; THEREFORE, NEEDLE WENT THROUGH INTO AN UNDESIRED LOCATION. THE LARGE BORE NEEDLE WAS ABLE TO SLIDE FREELY ON THE LOCKING HUB. THIS RESULTED IN AN UNEXPECTED ADVANCE OF THE NEEDLE 1 1/2" FURTHER THAN INTENDED WHILE WITHDRAWING FLUID.
THROMBOSIS OF SUBCLAVIAN VEIN. UNIT REMOVED AND IMPLANTED BY SAME PHYSICIAN.
OUTPATIENT HERE FOR CATARACT EXTRACTION LEFT EYE WITH IOL INSERTION. DURING PROCEDURE PHACO EMULSIFICATION HANDPIECE WAS USED. VISCOELASTIC HAD BEEN INSTILLED. SOMETHING KEPT STICKING ON PHACO TIP. THERMAL BURN OCCURRED.
AFTER CORONARY INJECTIONS HAD BEEN COMPLETED, PT WENT INTO V-TACH AND WAS DEFIBRILLATED X2 @ 200 W/S WITH CONVERSION. PT REMAINED UNSTABLE, WITH REPEATED DETERIORATION OF RHYTHM AND SUBSEQUENT DEFIBRILLATIONS. PHYSICIAN INSERTED IABP CATHETER. ATTENDING RN'S STATED THAT IT WOULD NOT AUGMENT. GAS LINE WAS CHECKED FOR LEAKS, WITH NONE FOUND. PHYSICIAN STATED THAT THERE WAS SOME BLOOD AT THE SITE OF THE CATHETER DISTAL END. BALLOON WAS SEEN TO INFLATE ONCE OR TWICE, BUT NO MORE THAN THAT. PT EXPIRED.
INTRUSION OF SCLERAL BUCKLING ELEMENT LEFT EYE. CURRENTLY NO SEVERE VISUAL PROBLEMS BUT HIGH LIKELIHOOD RETINAL DETACHMENT OR BLOCKAGE OF VISION BY ELEMENT LEFT EYE. DEVICE NOT IMPLANTED BY RPTR.
INTRUSION OF SCLERAL BUCKLING ELEMENT RIGHT EYE. CURRENTLY NO SEVERE VISUAL PROBLEMS BUT HIGH LIKELIHOOD RETINAL DETACHMENT OR BLOCKAGE OF VISION BY ELEMENT RIGHT EYE. DEVICE NOT IMPLANTED BY RPTR.
BILATERAL AUGMENTATION MAMMOPLASTY WITH INSERTION OF SILICONE GEL IMPLANTS WAS DONE SEVERAL YEARS AGO. IN THE PAST YEARS THE PT NOTICED A GENERALLY INCREASING DEFORMITY IN THE AUGMENTED LEFT BREAST WITH A BULGE EXTENDING TOWARD THE LEFT SHOULDER. MAMMOGRAPHY REVEALED A RUPTURED IMPLANT IN THE LEFT BREAST AND ALSO GRADE IV CAPSULAR CONTRACTURE IN THE RIGHT BREAST. TO CORRECT THE DEFORMITY, CAPSULECTOMY AND REMOVAL OF THE IMPLANTS WERE DONE. THE IMPLANTS WERE REPLACED WITH SALINE FILLED MAMMARY IMPLANTS IN BOTH RIGHT AND LEFT BREASTS.
AT 0955 CENTRAL VENOUS CATHETER WAS REMOVED BY PHYSICIAN DUE TO LEAKING IV SOLUTION AROUND INSERTION SITE. DURING REMOVAL BY PHYSICIAN, THE DISTAL PORTION OF CATHETER (15CM IN LENGTH) REMAINED IN PT, AFTER PROXIMAL PORTION WAS REMOVED. ON 7/15/95 AT 0830 PT TRIED TO GET OUT OF BED AND STRETCHED IV LINE AND CATHETER. PT FELL AT THIS TIME. CATHETER REMAINED IN TACT.
VENA CAVA FILTER INSERTED INTO PT FAILED TO DEPLOY. A SECOND FILTER WAS INSERTED AND THIS ONE DEPLOYED PROPERLY. WHEN THE SURGEON ATTEMPTED TO REMOVE THE FIRST ONE, IT DEPLOYED. A PORTION OF IT COULD NOT BE REMOVED. NO ADDITIONAL SURGERY WAS NEEDED, AND THERE WAS NO INJURY TO THE PT.
ON TWO RECENT OCCASIONS, PTS WERE NOTED TO HAVE SKIN BREAKDOWN AT THE PROBE SITE. THESE INCIDENTS OCCURRED AFTER PRECAUTIONARY MEASURES WERE IN PLACE. THE PT INFO FROM THE 2 RECENT INCIDENTS ARE AS FOLLOWS: PT 5 MONTH OLD. DIAGNOSIS: DOWNS SYNDROME STATUS POST REPAIR OF VENTRICULAR SEPTAL DEFECT. FIRST SITE LOCATION AND PHYSICIAN DESCRIPTION-ANTERIOR SURFACE LEFT GREAT TOE. 8 MM LONG BY 3 MM WIDE. ESCHAR NON BLANCHING. NO VESICULAR FORMATION. LESION-REDDISH-PURPLISH. POSTERIOR SURFACE 7MM BY 4MM VESICULAR LESION OVER DISTAL REGION TO SKIN CREASE. SECOND SITE LOCATION AND PHYSICIAN DESCRIPTION-RIGHT THUMB SURFACE ERYTHEMATOUS LESION. SMALL VESICULAR REGION. 6 MM BY 2 MM. THE PLASTIC SURGEON STATED "CANNOT DIFFERENTIATE BURN VERSUS PRESSURE ULCER PROBABLY COMBINATION OF BOTH." INCIDENT DATE: 11/2/95. PT #2: 4 MONTH OLD. DIAGNOSIS: MENINGITIS. SITE LOCATION-RIGHT THUMB. PURPLISH BLISTER. INCIDENT DATE: 11/9/95.
PT TO OR FOR ANT. CONVEAL CORPECTOMY WITH PLATE FIXATION. PHYSICIAN USING ANGLE HANDPIECE. DURING PROCEDURE OIL BUBBLES OF NON-STERILE OIL, LEAKED AT JOINT OF HANDPIECE ABOVE ANGLED CONNECTION. PROCEDURE STOPPED; PHYSICIAN REGLOVED AND NEW HANDPIECE USED, WITHOUT FURTHER COMPLICATIONS.
MECHANICAL COMPLICATION OF BREAST IMPLANTS. BILATERAL CAPSULAR CONTRACTURE WITH MASTODYNIA. RUPTURED SILICONE IMPLANT RIGHT BREAST AND INTACT LEFT BREAST. OPERATION: BILATERAL CAPSULECTOMY WITH REMOVAL OF SCAR TISSUE AND IMPLANTS AND REPLACEMENT WITH SALINE PROSTHESIS.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED WITH A DIFFERENT STYLE DEVICE.
DIFFICULTY WITH STENT TELESCOPING: SHEATH WOULD NOT TIGHTEN PROPERLY. STENT CATHETER INSERTED INTO PT. SHEATH PULLED BACK. STENT CATHETER REMOVED BEFORE STENT WAS DEPLOYED. STENT APPEARED DEFECTIVE UNDER DIGITAL FLUORO.
ACETABULAR CUP LOOSENING. THE PCA ACETABULAR COMPONENT AND FEMORAL HEAD WERE REMOVED AND REPLACED.
X-RAY SHOWED PROBABLE PATELLA WEAR THROUGH AND THINNING OF INSERT MEDIALLY. PATELLA WAS REMOVED AND REPLACED WITH ALL-POLY PATELLA AND INSERT EXCHANGED FOR AN 11MM THICK INSERT.
PACEMAKER IMPLANTED ON 1/16/95. PT RETURNING TO SURGERY TODAY DUE TO EROSION OF PACEMAKER POCKET.
AN OPTICAL LASER FIBER WAS RETURNED BECAUSE IT DID NOT WORK. THE CUSTOMER DESIRED CREDIT ONLY, AND THERE WAS NO REPORT OF INJURY. AFTER INSPECTION OF THE RETURNED PRODUCT WAS COMPLETED,IT WAS DETERMINED THAT THE PRODUCT NO LONGER FUNCTIONED BECAUSE OF A COMBINATION OF EXCESSIVE HEAT AND TISSUE DEBRIS ON THE TIP OF THE FIBER. THE USER IS ALERTED TO THIS POSSIBLE CONDITION AND ITS PREVENTATIVE MEASURES IN THE LABELING OF THE PRODUCT. DURING 6/95, THE RETURNED PRODUCT WAS INSPECTED. IT WAS OBSERVED THAT THE DISTAL TIP OF THE FIBER WAS NO LONGER PRESENT. UNDER MICROSCOPIC EXAMINATION, IT WAS CONCLUDED THAT THIS CONDITION WAS CAUSED BY USER ERROR.
A 57 YR OLD FEMALE UNDERWENT A BAM WITH IMPLANTATION OF SILICONE GEL BREAST IMPLANTS IN 1974. THIS PROCEDURE WAS PERFORMED AT ANOTHER FACILITY, THUS THIS REPORTING FACILITY DOES NOT KNOW THE MFR OF THE DEVICES. GROSS EXAM: NO EVIDENCE OF RUPTURE OF THE RIGHT IMPLANT, HOWEVER THERE IS A SMALL AMOUNT OF SILICONE NOTED ON THE IMPLANT. THE LEFT IMPLANT SHOWS A MINUTE FENESTRATION WHERE, UNDER PRESSURE, SMALL AMOUNT OF VISCOUS, GELATINOUS MATERIAL EXUDES THROUGH THE IMPLANT WALL.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED WITH ANOTHER STYLE PATELLA.
THIS 50 YR OLD FEMALE UNDERWENT BAM 19 YRS AGO WITH SILICONE GEL IMPLANTS. THE PROCEDURE WAS PERFORMED AT ANOTHER FACILITY, THUS THE MFR IS UNKNOWN TO THIS REPORTING FACILITY. THE PT HAS BEEN ASYMPTOMATIC, HOWEVER, HAS A MARKEDLY CONTRACTED AND IRREGULAR LEFT BREAST. GROSS EXAM: BOTH IMPLANTS ARE RUPTURED, EXUDING GELATINOUS TENACIOUS MATERIAL.
WHILE PREPARING FOR A CRYOSURGICAL PROCEDURE THE STAFF DETECTED A BURNING SMELL. THE SYSTEM WAS SHUT DOWN AND MOVED TO A ROOM WITH AN OUTSIDE VENT HOOD. UPON EXAMINATION IT WAS NOTED THE EXHAUST HEAT EXCHANGER HAD MELTED. NO PTS WERE IN THE ROOM AT THE TIME. THERE WAS NO KNOWN STAFF INJURY.
A 46 YR OLD FEMALE UNDERWENT BAM WITH SILICONE GEL BREAST IMPLANTS IN 1970. THIS PROCEDURE WAS PERFORMED AT ANOTHER FACILITY, THUS THIS REPORTING FACILITY DOES NOT KNOW THE MFR OF THE DEVICE. THE PT HAS SINCE DEVELOPED CALCIFIED BREAST MASSES BILATERALLY AND WISHED THE IMPLANTS BE REPLACED. GROSS EXAM: BOTH IMPLANTS EXUDE STICKY, VISCOUS, GELATINOUS MATERIAL THROUGH SMALL FENESTRATIONS NEXT TO MESH DISCS.
A 50 YR OLD FEMALE UNDERWENT BAM IN 1970 AT ANOTHER FACILITY, THUS THE MFR OF THE SILICONE GEL IMPLANTS IS UNKNOWN TO THIS REPORTING FACILITY. THE PT WAS RECENTLY IN A MVA WHERE SHE SUSTAINED A BLOW TO THE RIGHT BREAST. MAMMOGRAPHY SHOWED A PROBABLE RUPTURED BREAST IMPLANT. GROSS EXAM: THE RIGHT IMPLANT WAS RUPTURED AND EXUDED A CLEAR, GELATINOUS, TENACIOUS MATERIAL.
A 47 YR OLD FEMALE UNDERWENT A BAM WITH SILICONE GEL IMPLANTS IN 1980 AT  ANOTHER FACILITY. THUS, THE MFR IS NOT KNOWN TO THIS REPORTING FACILITY. THE PT RECENTLY NOTED NODULES AND CALCIFICATIONS IN IN LEFT BREAST AND CHOSE TO HAVE THE IMPLANTS REMOVED. GROSS EXAM: THE RIGHT IMPLANT IS INTACT, THE LEFT IS RUPTURED.
PT SUSTAINED V. FIB ARREST. IMPLANTED AICD DID NOT FUNCTION. ONCE PARAMEDICS ARRIVED AT SCENE, PT WAS DEFIBRILLATED SUCCESSFULLY. PT SUSTAINED ANOXIC BRAIN INJURY AND COMA.
REMOVAL OF R THUMB TRAPEZIAL IMPLANT (PROSTHESIS WAS FRACTURED IN 3 PLACES).
NURSING HOME RESIDENT ON TUBE FEEDING VIA TUBE FEEDING PUMP. THE TUBING  POPPED OUT OF THE ROTOR KNOB AND WAS FREE FLOW TUBE FEEDING TO THE RESIDENT, APPROX 700CC'S INFUSED FROM 6:00 A.M. UNTIL 7:30 A.M. ON 12/5/95. THE RESIDENT'S PHYSICIAN STATED THAT THE RESIDENT DIED OF PROBABLE ASPIRATION PNEUMONIA. THE INCIDENT OCCURRED AT 7:30 A.M., 12/5/95. THE RESIDENT DIED APPROX 6:15 P.M. ON 12/5/95.
WHILE CARING FOR TRAUMA PT, 2ND AND 3RD FINGERS ON RIGHT HAND WENT THROUGH TIP OF GLOVES EXPOSING FINGERS TO BLOODY FLUIDS.
AFTER THE INSERTION OF THE TROCAR, A SMALL CHIP IN THE PROXIMAL EDGE OF THE BLUE PLASTIC INSERT WAS NOTICED. TROCAR WAS WITHDRAWN. THE "CHIP" WAS SO SMALL THAT IT COULD NOT BE RETRIEVED OR LOCATED.
DURING THYROIDECTOMY, WHILE WOUND WAS FULLY OPEN, AN UNSTERILE "SWIVEL CAP" FELL OFF SPOTLIGHT #2 DIRECTLY INTO WOUND. CAP REMOVED FROM WOUND. PT TREATED WITH PROPHYLACTIC ANTIBIOTICS.
SURGEON WAS USING AN OSTEOTOME TO LOOSEN A FEMORAL KNEE PROSTHESIS INTRA-OPERATIVELY WHEN THE OSTEOTOME SLIPPED FROM THE SURGEON'S HAND, STRIKING HIS RIGHT PALM AND INFLICTING AN OPEN LACERATION TO THE BASE OF THE THUMB. AN ARTERIOLE WAS LACERATED WHICH WAS SUTURED BY ANOTHER SURGEON FOLLOWING IRRIGATION OF WOUND WITH AN ANTIBIOTIC IRRIGATION SOLUTION.
WHILE DOING NEEDLE LOCALIZATION THE CAP OF THE NEEDLE DID NOT LOCK PROPERLY. WHEN THE TISSUE WAS COMPRESSED THE WIRE NEEDLE ADVANCED INTO THE BREAST. NEEDLE WAS REMOVED DURING SUBSEQUENT SURGICAL PROCEDURE.
PT WAS ADMITTED TO THE HOSP AND UNDERWENT INSTRUMENTATION OF THE LUMBAR SPINE, AT WHICH TIME A 1/8" DRAIN WAS PLACED. TWO DAYS POSTOPERATIVELY, AN ATTEMPT WAS MADE TO REMOVE THE DRAIN. THE PHYSICIAN PULLED THE DRAIN AND IT WAS FELT TO BE HUNG IN THE INSTRUMENTATION. THE PT WAS TAKEN TO THE SURGERY SUITE WHERE THE DRAIN WAS PULLED AND FOUND TO BE STUCK. AFTER THE PT UNDERWENT GENERAL ANESTHESIA INDUCTION, THE DRAIN WAS FINALLY RELEASED. AN AP VIEW OF THE LUMBAR SPINE WAS OBTAINED WHICH REVEALED NO SIGN OF RETAINED DRAIN.
PT WAS BEING SET-UP ON EXERCISE MACHINE FOR TREATMENT OF LEFT FOOT/ANKLE. WHEN ATTEMPTING TO SET RANGE OF MOTION LIMITS, THE MACHINE FORCEFULLY ROTATED IN THE COUNTER-CLOCKWISE DIRECTION AND THEN LOCKED IN THAT POSITION.
SURGEON WAS USING A FINGER TRAP WHEN THE TRAP BROKE. NURSE WAS HOLDING PT'S ARM WHICH PREVENTED INJURY TO THE PT. INVESTIGATION OF INCIDENT SHOWS THAT THESE DEVICES HAVE PULLED APART BEFORE BUT WAS NOT REPORTED AT THAT TIME.
PT DEVELOPED MILD CAPSULAR CONTRACTURE WITH SOME DISCOMFORT ON LEFT SIDE, AND IS CONCERNED ABOUT SILICONE IMPLANTS; EXPLANT BILATERAL SILICONE GEL IMPLANTS.
HISTORY OF BILATERAL BREAST AUGMENTATION & SUBSEQUENT BILATERAL REDUCTION REPLACEMENT OF IMPLANTS. PT NOW HAS BILATERAL CAPSULAR CONTRACTURE AND PAIN; WANTS IMPLANTS REMOVED.
PT WENT INTO ASYSTOLE OR SEVERE BRADYCARDIA. PER PT AND FAMILY, CODE STATUS WAS CHANGED PRIOR TO EVENT TO A CHEMICAL CODE ONLY (NO MEDICATIONS AND EXTERNAL PACING AT A RATE OF 70 & MA 60). DEFIBRILLATOR UTILIZED UNSUCCESSFULLY. EXCHANGED WITH ANOTHER DEFIBRILLATOR OF THE SAME BRAND FROM FLOOR (PT WAS IN RICU) WHICH PACED PER MD ORDER. PT'S RESPONSE WAS POOR THROUGHOUT CODE. MD SPOKE WITH SON AND CHANGED STATUS TO DNR, STOPPED MEDICATIONS AND PT EXPIRED. MFR'S BIOMED CONTACTED 12/18 AND RESPONDED 12/19 TO CHECK THE DEVICES. ALL CHECKED OUT FINE SO INVESTIGATION CONTINUES INTO USER ERROR. PHYSICIAN REVIEW OF THE CASE WAS CONDUCTED. ALL MDS UNABLE TO DETERMINE IF OUTCOME WOULD HAVE BEEN DIFFERENT IF PACING HAD WORKED IMMEDIATELY.
ADAPTER HAS BEEN LEAKING. THE USERS HAVE BEEN UNABLE TO MAKE A SECURE CONNECTION. ONE PT CONTRACTED PERITONITIS WHICH WAS THOUGHT TO BE RELATED TO THE CRACKED/LEAKING ADAPTOR.
WALKED INTO SHARED BATHROOM OF RESIDENTS' ROOM. ROOM WAS HAZY W/SMOKE & FUMES OF ELECTRICAL ODORS. PT REMOVED FROM ROOM. REPORTER ALERTED OTHER STAFF. PRIOR TO THAT TIME, THE LIFT HAD BEEN USED BY ANOTHER CNA. WHEN THE LIFT DID NOT WORK, THE CNA PUSHED THE "EMERGENCY DOWN BUTTON." THE LIFT WENT DOWN BUT STILL WAS NOT USABLE. THE CNA LEFT THE ROOM TO OBTAIN LIFTING ASSISTANCE.
PROSTHESIS BECAME LODGED DURING INSERTION. TAB TORE OFF NECESSITATING REMOVAL IN OR. CO HAS RECEIVED A COMPLAINT REGARDING A TORN OFF INSERTION TAIL ON A VOICE PROSTHESIS. THE TAIL HAS TORN OFF WHEN THE PROSTHESIS WAS DRAWN THROUGH THE ESOPHAGUS TOWARDS THE FISTULA. THE DR CLAIMS THAT THE PROSTHESIS WAS STUCK AFTER WHICH HE PULLED UNTIL THE TAIL BROKE OFF. CO HAS INVESTIGATED THE PROSTHESIS, ESPECIALLY WITH REGARD TO THE FRACTURED SURFACES. THE FRACTURED SURFACE WAS STRIKINGLY IRREGULARLY TOOTHED WITH DEFINED MARKS, WHICH DEFINITELY DO NOT CORRESPOND WITH FRACTURED SURFACES ARISEN FROM FRACTURES BY PULLING. WITH REGARD TO THE FRACTURED SURFACE, THE TAIL HAS PROBABLY BEEN DEFORMED BY SOME SHARP INSTRUMENT LIKE FOR INSTANCE HEMASTATIC FORCEPS.
WHILE PERFORMING A TRIPLE ARTHRODESIS USING A CANNULATED SCREW, THE TIP OF THE CANNULATED 4.5MM TAP BROKE OFF. THIS WAS NOTICED UPON TAKING X-RAYS NEAR THE END OF SURGERY. THE SURGEON WAS ADVISED BY THE FACTORY TO REMOVE BROKEN TIP. THE RETRIEVAL AND REINSERTION OF THE SCREW EXTENDED OPERATIVE TIME BY APPROX 2 HRS.
ON 1/23 DISTRIBUTOR RECEIVED A REPORT OF AN ALLEGED MALFUNCTION OF A MONITOR. THE SOURCE WAS NOTIFIED OF REPRESENTATION RECEIVED FROM A LAW OFFICE. NO OTHER INFO ON THE DEVICE OR ANY POSSIBLE INVOLVEMENT OF DISTRIBUTOR IN THE ALLEGED INJURY IS AVAILABLE AT THIS TIME.
POLY WEAR ON TIBIAL INSERT AND PATELLA. THE TIBIAL INSERT WAS REMOVED AND IMPLANTED WITH A 9MM INSERT. THE PATELLA WAS REMOVED BUT NOT REPLACED.
PENILE IMPLANT INSERTED 7/31/95. UNABLE TO INFLATE DEVICE.
DURING A LAPAROSCOPIC TUBAL STERILIZATION PROCEDURE, THE PT'S UTERUS WAS PERFORATED. PRODUCT INSTRUCTIONS REQUIRE SOUNDING OF THE UTERUS IN ORDER TO ACCURATELY CHOOSE APPROPRIATE SIZE DEVICE. UPON INVESTIGTION OF THE INCIDENT, IT IS BELIEVED THAT SOUNDING HAD NOT OCCURRED. THE TIP ITSELF WAS OBSERVED TO FUNCTION APPROPRIATELY OUTSIDE OF THE UTERINE CAVITY.
PT'S RHYTHM CHANGED FROM ST TO FINE V-FIB. MONITOR DID NOT ALARM NOR WAS STRIP RUN. NURSE WAS AT PT BEDSIDE AND WITNESSED CHANGES. NEITHER THE  BEDSIDE MONITOR NOR THE ALARM AT DESK ALARMED. THE PT EXPIRED; HOWEVER, NOT DUE TO DEVICE MALFUNCTION. NO ADVERSE OUTCOMES KNOWN. DEVICE WAS EVALUATED BY CO ON 10/31/95. DEVICE HAS BEEN PUT BACK IN SERVICE.
DISCORDANT PT RESULT WAS OBTAINED WHEN TESTING A SAMPLE USING THE COAGULATION ANALYZER. FLAT CURVE WITH NO ERROR CODE WAS OBTAINED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST. THE RESULT OBTAINED ON THE ANALYZER WAS REPORTED. SUBSEQUENTLY, THE SAMPLE WAS VERIFIED AGAINST A BACK-UP INSTRUMENT AND THE RESULT OBTAINED ON THE FIRST INSTRUMENT WAS DISCORDANT. NO FURTHER INFO IS KNOWN AS TO THE STATUS OF THE PT. IT IS UNCLEAR WHETHER THE LABORATORY WAS FOLLOWING PROPER PRIMING/RINSING PROCEDURES FOR THE ANALYZER. THE RESULTS ARE AS FOLLOWS: CO'S PRODUCT DUPL 1 135 SEC (RESULT CONFIRMED ON DUPLICATE) AND BACK-UP INSTRUMENT 50 SEC.
DISCORDANT PT RESULTS WERE OBTAINED WHEN TESTING A HEPARINIZED SAMPLE USING THE COAGULATION ANALYZER. FLAT CURVES WITH NO ERROR CODE WERE OBTAINED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST. THE RESULTS OBTAINED ON THE ANALYZER WERE NOT REPORTED. THE SAMPLE WAS ALSO TESTED WITH A REFERENCE METHOD AND THIS RESULT WAS REPORTED. THE RESULTS OBTAINED ARE AS FOLLOWS: APTT ON CO'S PRODUCT, SPECIMENT/RUN 1 = 9.9 SEC* (REFERENCE = 120 SEC), SPECIMEN/RUN 2 = 11.0 SEC*, SPECIMENT/RUN 3 = 97.9 SEC (*FLAT CURVES WITH NO ERROR CODE WERE OBSERVED WITH THESE RUNS).
DURING GASTRIC POLYPECTOMY THE SNARE CANNULA CRUMPLED WHICH LIMITED "GUILLOTINE" PRESSURE ON POLYPS AND REQUIRED ADD'L CAUTERY. NO ADVERSE EFFECT TO PT.
DURING PTCA PROCEDURE BY A CARDIOLOGIST, THE DISTAL TIP OF THE GUIDE WIRE (APPROX 10MM) BROKE OFF AND LODGED IN THE DISTAL PART OF THE RIGHT PDA CORONARY VESSEL. THE PT'S CONDITION WAS STABLE, THE VITAL SIGNS STABLE, AND NO ADVERSE REACTION WAS NOTED. THE ECG DOES NOT INDICATE ANY DETERIORATION IN THE PT'S CONDITION. NO CHEST PAIN OR EKG CHANGES ARE PRESENT.
PERFORATOR DID NOT STOP AS SOON AS CRANIUM WAS PENETRATED.
PT UNDERWENT OPEN CHOLECYSTECTOMY ON 12/7/95, WITH PLACEMENT OF 10MM DRAIN IN THE GALLBLADDER FOSSA. ON 12/9/95, WHILE PULLING THE DRAIN OUT, THE TUBE BROKE AND THE DRAIN WAS RETAINED INSIDE. PT UNDERWENT REMOVAL OF THE DRAIN WITHOUT COMPLICATION ON 12/12/95.
REMOVAL OF BREAST IMPLANTS. GRADE IV CAPSULAR CONTRACTURE.
PT PRESENTED TO PHYSICIAN'S OFFICE TO HAVE PORT REMOVED WHEN A PIECE BROKE OFF AND LODGED IN RIGHT ATRIUM. DETACHED PORTION OF CATHETER REMOVED IN X-RAY UNDER FLUORO.
DURING PTCA, PHYSICIAN ATTEMPTED TO REMOVE BALLOON FROM CORONARY ARTERY. THE BALLOON WOULD NOT SLIDE FREELY OVER CORONARY PTCA WIRE. BALLOON WIRE REMOVED TOGETHER AFTER REMOVAL, THE WIRE WAS NOTED TO BE FRAYED.
DURING ROTATIONAL ATHERECTOMY PROCEDURE, CORONARY WIRE BROKE. SEGMENT LEFT IN LEFT CIRCUMFLEX ARTERY. PT SENT TO EMERGENCY OPEN HEART SURGERY. PT DISCHARGED TO HOME 1/18/96.
REPLACEMENT OF SILICONE IMPLANTS WITH SALINE IMPLANTS.
REPLACING OLD SILICONE IMPLANTS WITH NEW SILICONE IMPLANTS. BILATERAL CAPSULAR CONTRACTURES.
REMOVAL OF BREAST IMPLANTS. PT. DISSATISFIED WITH SIZE.
PT DISSATISFIED; REQUESTED A DIFFERENT MODEL.
DEVICE FUNCTIONING IMPROPERLY; NOT STAYING ERECT, FLUID LOSS.
LESS THAN 1MM RELATIVELY HIGH DENSITY FOCUS PROJECTING IN THE GENERAL REGION OF THE BIOPSY ON FINAL STEREOTATIC IMAGE. NEEDLE WAS MINIMALLY BENT OR TRUNCATED. QUESTION PORTION MISSING.
TIP OF NEEDLE APPEARED DISTORTED AFTER PROCEDURE. OPACITY, 1MM, NOTED ON X-RAY OPACITY REMOVED. TIP OF NEEDLE BROKE OFF DURING PROCEDURE.
UPON ADMISSION, 1/6/96, THE PT HAD BEEN COMPLAINING OF RIGHT CHEST WALL PAIN AND RIGHT SHOULDER PAIN FOR THE LAST FOUR DAYS, BUT DENIED ANY PRODUCTIVE COUGH, DYSURIA, DIARRHEA, NAUSEA OR VOMITING. SHE WAS ADMITTED TO THE HOSP WITH NEUTROPENIC FEVER AND ON ADMISSION WAS FOUND TO BE ANEMIC. AFTER ADMISSION THE PT'S COURSE HAD BEEN ONE OF FAIRLY QUICK DETERIORATION. ON 1/7/96, THE PT'S RESPIRATORY STATUS DETERIORATED, SUCH THAT INTUBATION WAS NECESSITATED AND THE PT WAS PLACED ON MECHANICAL VENTILATION. THE PT WAS ON A VENTILATOR WITH A DISPOSABLE CIRCUIT ATTACHED. ALSO IN USE WAS A NON-DISPOSABLE EXHALATION VALVE WATER COLLECTOR KIT AND FLOW TUBE/ONE-WAY CHECK VALVE ASSEMBLY THAT WAS ATTACHED TO THE LOWER LEFT SIDE OF THE VENTILATOR FRAME. THE VENTILATOR SETTINGS WERE AS FOLLOWS: TIDAL VOLUME .700L, RATE ASSIST/CONTROL 20/MINUTE, FIO2 .60, PEEP 12 CM H2O. THE ALARM SETTINGS WERE AS FOLLOWS: PRESSURE LIMIT 65 CM H20, LOW VOLUME .500 L, LOW INSPIRATORY PRESSURE 30 CM H2O, AND APNEIC PERIOD 20 SECONDS. THE RN CHECKED ON THE PT'S STATUS AND FOUND THE VENTILATOR ALARMING, THE PT WAS CYANOTIC AND CROWING AROUND THE CUFF. THE PT WAS TAKEN OFF THE VENTILATOR AND WAS BAGGED WITH 100% OXYGEN, UNTIL THE HEART RATE AND OXYGEN SATURATION (SAO2) INCREASED. THE PT WAS RECONNECTED TO THE VENTILATOR AND THE RESPIRATORY THERAPIST IMMEDIATELY IDENTIFIED THE PT WAS NOT VENTILATING PROPERLY. THE PT WAS IMMEDIATELY REMOVED FROM THE VENTILATOR AND BAGGED WITH 100% OXYGEN. MEANWHILE, THE RESPIRATORY THERAPIST PERFORMED TROUBLE-SHOOTING PROCEDURES ON THE VENTILATOR/CIRCUIT. THE RESPIRATORY THERAPIST FOUND THE EXHALATION TUBING CONNECTED TO THE OUTLET PORTION OF THE ONE-WAY VALVE ASSEMBLY. THE EXHALATION TUBING WAS REMOVED FROM THE ONE-WAY VALVE AND RECONNECTED TO THE INLET PORT OF THE WATER COLLECTOR ASSEMBLY. AS A RESULT OF THE INADVERTENT CONNECTION, THE PT DEVELOPED A TENSION PNEUMOTHORAX AND EXPIRED.
REMOVAL OF SILICONE IMPLANT. R RUPTURED IMPLANT. L INTACT.
THE DEVICE WAS ATTACHED TO THE PT AND THE COMPONENTS FELL APART. MESH SCREEN WAS SUPPOSED TO BE FACING THE DRAIN BAG AND IT WAS LOOSE.
DURING STENT PLACEMENT A 3.5 STENT CATHETER WAS DEPLOYED. THE BALLOON RUPTURED AFTER PARTIAL INFLATION AND HAD TO BE REMOVED, WHICH RESULTED IN THE PT BECOMING HYPOTENSIVE WITH BRADYCARDIA AND UNRESPONSIVE. CPR WAS STARTED AND MEDS GIVEN. PT BEGAN BREATHING ON OWN AGAIN AFTER THIS SHORT EPISODE OF UNRESPONSIVENESS. THE LESION WAS DILATED WITH BALLOON ANGIOPLASTY AND PT WAS TRANSFERRED TO INTENSIVE CARE IN STABLE CONDITION. PT WAS DISCHARGED ON 8/24.
PHYSICIAN REMOVED DRAIN AND RIGHT DRAIN BROKE OFF IN PT. REMOVAL OF DRAIN WAS UNWITNESSED BY PERSONNEL. PT REQUIRED ARTHROTOMY ON 1/31/96 TO REMOVE RETAINED FOREIGN BODY. 6" OF PLASTIC DRAIN WAS REMOVED. PT BILATERAL TOTAL KNEE REPLACEMENT 1/30/96.
PT HAD A LEFT INGUINAL HERNIA REPAIR WITH MESH PLACEMENT ON 8/3/95. THE PT HAD INCREASING PAIN AND ON 9/1/95 HAD THE MESH REMOVED. AT THE TIME OF MESH REMOVAL IT WAS NOTED THAT THE PT HAD SOME PURULENT MATERIAL LOCATED IN THE AREA OF THE MESH ONLY. THE PT HAD NO VISUAL SIGNS OF INFECTION. CULTURES TAKEN OF THE PURULENT MATERIAL AND MESH GREW PSEUDOMONAS AERUGINOSA. THE PT WAS READMITTED 9/19/95 FOR PUBIC OSTEITIS/OSTEOMYELITIS.
RPTR HAS RECEIVED TWO SEPARATE COMPLAINTS REGARDING THIS RPODUCT. 1) DIFFICULT TO TURN/CAN'T PRIME. TWO DEVICES RETURNED TO MFR. LOT #S UNKNOWN. 2) DEVICE INFUSING TOO FAST. SEVERAL INCIDENTS LATE 12/95, 3 INCIDENTS 11/29/96 (LOTS LISTED) 1 INCIDENT 1/25/96, 1 ON 1/26/96 (NO LOTS). DEVICES RETURNED TO MFR.
IOL REMOVED DUE TO EVISCERATION OF EYE DUE TO END-STAGE GLAUCOMA AND PAINFUL EYE.
A 70 YR OLD MALE PT WHO IS STATUS POST PROSTATE CANCER WITH RADICAL PROSTATECTOMY, PENILE PROSTHESIS INSERTED IN 1988, WAS ADMITTED ON 12/4/95  FOR REMOVAL OF THE PROSTHESIS. HAD NOT FUNCTIONED FOR APPROX TWO YRS. SALES REP WAS PRESENT AT THE TIME OF EXPLANT.
AN 89-YR-OLD FEMALE PT GOT OUT OF BED WITHOUT CALLING FOR ASSISTANCE, FELL, AND SUSTAINED A TRANSCERVICAL FRACTURE OF THE RIGHT PROXIMAL FEMUR, WITH DISPLACEMENT AND ANGULATION. THE PT UNDERWENT RIGHT HEMIARTHROPLASTY ON 12/12/95. THE BED ALARM FAILED TO ALARM.
DURING A CIRCUMCISION, THE CIRCUMCISION CLAMP FAILED TO CLAMP PROPERLY WHICH RESULTED IN BLEEDING FROM THE CIRCUMCISION SITE AND REQUIRED SUTURING. THE EVENT PROLONGED HOSPITALIZATION TWO HOURS. A RATTLE CAN BE HEARD WHEN DEVICE IS MOVED.
RPTR HAD 7 AUGMENTATIONS FROM 1974 TO 1990. SIDE EFFECTS INCLUDED INFECTION, RUPTURE, CHRONIC PAIN AND FATIGUE, CHRONIC INFLAMMATION, SPEECH AND VISION PROBLEMS, DISCHARGE FROM NIPPLE, HUMAN ADJUVANT DISEASE, FIBROMYALGIA. ACCORDING TO A MEDICAL AND NEUROLOGIC EVALUATION 1/30/95: PT REPORTS BEING IN HER USUAL EXCELLENT STATE OF MEDICAL, NEUROLOGIC, AND PSYCHIATRIC HEALTH WHEN SHE CONSULTED THE DR FOR COSMETIC AUGMENTATION MAMMOPLASTY WITH INSERTION OF BILATERAL SILICONE GEL IMPLANTS. SHE DEVELOPED SOME IMMEDIATE DECREASED SENSATION IN THE NIPPLES, WHICH WITH TIME CHANGED TO A MILD HYPERSENSITIVITY. OTHERWISE, THERE WERE NO IMMEDIATE COMPLICATIONS FROM THIS SURGERY. HOWEVER, ONE WEEK LATER, PT WAS INVOLVED IN AN AUTOMOBILE ACCIDENT. SHE IMMEDIATELY DEVELOPED BURNING PAIN IN HER BREASTS, AND IMPLANTS WERE KNOCKED INTO NEW POSITIONS, WITH ONE OBVIOUSLY AT A DIFFERENT LEVEL THAN THE OTHER. NO IMMEDIATE RECONSTRUCTION WAS ATTEMPTED, WITH THE HOPE THAT WITH TIME IMPLANTS WOULD RELOCATE TO A BETTER POSITION ON THEIR OWN. HOWEVER, INSTEAD, BOTH IMPLANTS HARDENED MARKEDLY, ESPECIALLY ON THE RIGHT, AND DID NOT IMPROVE IN PLACEMENT. DUE TO THE UNACCEPTABLE HARDENING AND PLACEMENT, PT WAS REOPERATED IN 1975, WITH FINDINGS OF BILATERAL IMPLANT RUPTURE. NEW IMPLANTS WERE PLACED AT THAT TIME. SHORTLY THEREAFTER, BOTH IMPLANTS HARDENED, ESPECIALLY ON THE RIGHT, AND SEVERAL CLOSED CAPSULOTOMIES WERE PERFORMED, WHICH EVENTUALLY SOFTENED THE LEFT IMPLANT, BUT COULD NOT EFFECTIVELY SOFTEN THE RIGHT ONE. IN 1978, THE RIGHT IMPLANT AND EXTENSIVE SCAR TISSUE WERE REMOVED AND A NEW IMPLANT PLACED ON THE RIGHT. THIS IMPLANT AGAIN MARKEDLY HARDENED AND WAS REPLACED AGAIN IN 1979, 1982, AND 1982, WITH SEVERE RE-HARDENING AND PAIN EACH TIME. STINGING AND BURNING PAINS IN THE CHEST AND BREAST AREAS PERSISTED. BETWEEN 1985 AND 1990, THERE WAS AGAIN SEVERE RE-HARDENING ON THE RIGHT "LIKE A ROCK." IN 1990, PT HAD BOTH IMPLANTS REMOVED AND NEW IMPLANTS PLACED. IN ADDITION TO THE HARDENING, PT DEVELOPED A RIGHT NIPPLE DISCHARGE FROM THE LATE 1970S UP UNTIL THE 1990 SURGERY. IN REGARDS TO THE MEDICAL CONDITIONS AND CHARACTERISTICS OUTLINE OF DEFINITIONS AND CLASSIFICATION CRITERIA TO THE GLOBAL RESOLUTION OF BREAST IMPLANT CLAIMS, THE PT INITIALLY MET AT LEAST FIVE CRITERIA FOR CATEGORY ATYPICAL CONNECTIVE TISSUE DISEASE/ATYPICAL RHEUMATIC SYNDROME/NON-SPECIFIC AUTOIMMUNE CONDITION BY 1975. SHE HAS MANIFESTED THE FOLLOWING CRITERIA: POLYARTHRALGIAS, POLYMYALGIAS, IMMUNE MEDIATED SKIN CHANGES, PULMONARY SYMPTOMS WITH FREQUENT UPPER RESPIRATORY INFECTIONS, MEMORY AND CONCENTRATION PROBLEMS, HEADACHES, PANIC ATTACKS, PARESTHESIAS, AND HEMIFACIAL SPASM, CHRONIC FATIGUE, ALOPECIA, SLEEP DISTURBANCES, SUSTAINED BALANCE PROBLEMS, EASY BRUISABILITY, COLITIS/IRRITABLE BOWELS, PERSISTENT LOW GRADE FEVER, PERSISTENT DRENCHING NIGHT SWEATS, BURNING BREAST AND CHEST PAIN WITH BREAST DISFIGUREMENT. CHRONIC INFLAMMATORY CHANGES. (*) (ALSO SEE 1008266, 1008267, 1008268).
RPTR HAD 7 AUGMENTATIONS FROM 1974 TO 1990. SIDE EFFECTS INCLUDED INFECTION, RUPTURE, CHRONIC PAIN AND FATIGUE, CHRONIC INFLAMMATION, SPEECH AND VISION PROBLEMS, DISCHARGE FROM NIPPLE, HUMAN ADJUVANT DISEASE, FIBROMYALGIA. ACCORDING TO A MEDICAL AND NEUROLOGIC EVALUATION 1/30/95: PT REPORTS BEING IN HER USUAL EXCELLENT STATE OF MEDICAL, NEUROLOGIC, AND PSYCHIATRIC HEALTH WHEN SHE CONSULTED THE DR FOR COSMETIC AUGMENTATION MAMMOPLASTY WITH INSERTION OF BILATERAL SILICONE GEL IMPLANTS. SHE DEVELOPED SOME IMMEDIATE DECREASED SENSATION IN THE NIPPLES, WHICH WITH TIME CHANGED TO A MILD HYPERSENSITIVITY. OTHERWISE, THERE WERE NO IMMEDIATE COMPLICATIONS FROM THIS SURGERY. HOWEVER, ONE WEEK LATER, PT WAS INVOLVED IN AN AUTOMOBILE ACCIDENT. SHE IMMEDIATELY DEVELOPED BURNING PAIN IN HER BREASTS, AND IMPLANTS WERE KNOCKED INTO NEW POSITIONS, WITH ONE OBVIOUSLY AT A DIFFERENT LEVEL THAN THE OTHER. NO IMMEDIATE RECONSTRUCTION WAS ATTEMPTED, WITH THE HOPE THAT WITH TIME IMPLANTS WOULD RELOCATE TO A BETTER POSITION ON THEIR OWN. HOWEVER, INSTEAD, BOTH IMPLANTS HARDENED MARKEDLY, ESPECIALLY ON THE RIGHT, AND DID NOT IMPROVE IN PLACEMENT. DUE TO THE UNACCEPTABLE HARDENING AND PLACEMENT, PT WAS REOPERATED IN 1975, WITH FINDINGS OF BILATERAL IMPLANT RUPTURE. NEW IMPLANTS WERE PLACED AT THAT TIME. SHORTLY THEREAFTER, BOTH IMPLANTS HARDENED, ESPECIALLY ON THE RIGHT, AND SEVERAL CLOSED CAPSULOTOMIES WERE PERFORMED, WHICH EVENTUALLY SOFTENED THE LEFT IMPLANT, BUT COULD NOT EFFECTIVELY SOFTEN THE RIGHT ONE. IN 1978, THE RIGHT IMPLANT AND EXTENSIVE SCAR TISSUE WERE REMOVED AND A NEW IMPLANT PLACED ON THE RIGHT. THIS IMPLANT AGAIN MARKEDLY HARDENED AND WAS REPLACED AGAIN IN 1979, 1982, AND 1982, WITH SEVERE RE-HARDENING AND PAIN EACH TIME. STINGING AND BURNING PAINS IN THE CHEST AND BREAST AREAS PERSISTED. BETWEEN 1985 AND 1990, THERE WAS AGAIN SEVERE RE-HARDENING ON THE RIGHT "LIKE A ROCK." IN 1990, PT HAD BOTH IMPLANTS REMOVED AND NEW IMPLANTS PLACED. IN ADDITION TO THE HARDENING, PT DEVELOPED A RIGHT NIPPLE DISCHARGE FROM THE LATE 1970S UP UNTIL THE 1990 SURGERY. WITH REGARDS TO THE MEDICAL CONDITIONS AND CHARACTERISTICS OUTLINE OF DEFINITIONS AND CLASSIFICATION CRITERIA TO THE GLOBAL RESOLUTION OF BREAST IMPLANT CLAIMS, THE PT INITIALLY MET AT LEAST FIVE CRITERIA FOR CATEGORY ATYPICAL CONNECTIVE TISSUE DISEASE/ATYPICAL RHEUMATIC SYNDROME/NON-SPECIFIC AUTOIMMUNE CONDITION BY 1975. SHE HAS MANIFESTED THE FOLLOWING CRITERIA: POLYARTHRALGIAS, POLYMYALGIAS, IMMUNE MEDIATED SKIN CHANGES, PULMONARY SYMPTOMS WITH FREQUENT UPPER RESPIRATORY INFECTIONS, MEMORY AND CONCENTRATION PROBLEMS, HEADACHES, PANIC ATTACKS, PARESTHESIAS, AND HEMIFACIAL SPASM, CHRONIC FATIGUE, ALOPECIA, SLEEP DISTURBANCES, SUSTAINED BALANCE PROBLEMS, EASY BRUISABILITY, COLITIS/IRRITABLE BOWELS, PERSISTENT LOW GRADE FEVER, PERSISTENT DRENCHING NIGHT SWEATS, BURNING BREAST AND CHEST PAIN WITH BREAST DISFIGUREMENT. CHRONIC INFLAMMATORY CHANGES. (*) (ALSO SEE 1008265, 1008267, 1008268).
RPTR HAD 7 AUGMENTATIONS FROM 1974 TO 1990. SIDE EFFECTS INCLUDED INFECTION, RUPTURE, CHRONIC PAIN AND FATIGUE, CHRONIC INFLAMMATION, SPEECH AND VISION PROBLEMS, DISCHARGE FROM NIPPLE, HUMAN ADJUVANT DISEASE, FIBROMYALGIA. ACCORDING TO A MEDICAL AND NEUROLOGIC EVALUATION 1/30/95: PT REPORTS BEING IN HER USUAL EXCELLENT STATE OF MEDICAL, NEUROLOGIC, AND PSYCHIATRIC HEALTH WHEN SHE CONSULTED THE DR FOR COSMETIC AUGMENTATION MAMMOPLASTY WITH INSERTION OF BILATERAL SILICONE GEL IMPLANTS. SHE DEVELOPED SOME IMMEDIATE DECREASED SENSATION IN THE NIPPLES, WHICH WITH TIME CHANGED TO A MILD HYPERSENSITIVITY. OTHERWISE, THERE WERE NO IMMEDIATE COMPLICATIONS FROM THIS SURGERY. HOWEVER, ONE WEEK LATER, PT WAS INVOLVED IN AN AUTOMOBILE ACCIDENT. SHE IMMEDIATELY DEVELOPED BURNING PAIN IN HER BREASTS, AND IMPLANTS WERE KNOCKED INTO NEW POSITIONS, WITH ONE OBVIOUSLY AT A DIFFERENT LEVEL THAN THE OTHER. NO IMMEDIATE RECONSTRUCTION WAS ATTEMPTED, WITH THE HOPE THAT WITH TIME IMPLANTS WOULD RELOCATE TO A BETTER POSITION ON THEIR OWN. HOWEVER, INSTEAD, BOTH IMPLANTS HARDENED MARKEDLY, ESPECIALLY ON THE RIGHT, AND DID NOT IMPROVE IN PLACEMENT. DUE TO THE UNACCEPTABLE HARDENING AND PLACEMENT, PT WAS REOPERATED IN 1975, WITH FINDINGS OF BILATERAL IMPLANT RUPTURE. NEW IMPLANTS WERE PLACED AT THAT TIME. SHORTLY THEREAFTER, BOTH IMPLANTS HARDENED, ESPECIALLY ON THE RIGHT, AND SEVERAL CLOSED CAPSULOTOMIES WERE PERFORMED, WHICH EVENTUALLY SOFTENED THE LEFT IMPLANT, BUT COULD NOT EFFECTIVELY SOFTEN THE RIGHT ONE. IN 1978, THE RIGHT IMPLANT AND EXTENSIVE SCAR TISSUE WERE REMOVED AND A NEW IMPLANT PLACED ON THE RIGHT. THIS IMPLANT AGAIN MARKEDLY HARDENED AND WAS REPLACED AGAIN IN 1979, 1982, AND 1982, WITH SEVERE RE-HARDENING AND PAIN EACH TIME. STINGING AND BURNING PAINS IN THE CHEST AND BREAST AREAS PERSISTED. BETWEEN 1985 AND 1990, THERE WAS AGAIN SEVERE RE-HARDENING ON THE RIGHT "LIKE A ROCK." IN 1990, PT HAD BOTH IMPLANTS REMOVED AND NEW IMPLANTS PLACED. IN ADDITION TO THE HARDENING, PT DEVELOPED A RIGHT NIPPLE DISCHARGE FROM THE LATE 1970S UP UNTIL THE 1990 SURGERY. WITH REGARDS TO THE MEDICAL CONDITIONS AND CHARACTERISTICS OUTLINE OF DEFINITIONS AND CLASSIFICATION CRITERIA TO THE GLOBAL RESOLUTION OF BREAST IMPLANT CLAIMS, THE PT INITIALLY MET AT LEAST FIVE CRITERIA FOR CATEGORY ATYPICAL CONNECTIVE TISSUE DISEASE/ATYPICAL RHEUMATIC SYNDROME/NON-SPECIFIC AUTOIMMUNE CONDITION BY 1975. SHE HAS MANIFESTED THE FOLLOWING CRITERIA: POLYARTHRALGIAS, POLYMYALGIAS, IMMUNE MEDIATED SKIN CHANGES, PULMONARY SYMPTOMS WITH FREQUENT UPPER RESPIRATORY INFECTIONS, MEMORY AND CONCENTRATION PROBLEMS, HEADACHES, PANIC ATTACKS, PARESTHESIAS, AND HEMIFACIAL SPASM, CHRONIC FATIGUE, ALOPECIA, SLEEP DISTURBANCES, SUSTAINED BALANCE PROBLEMS, EASY BRUISABILITY, COLITIS/IRRITABLE BOWELS, PERSISTENT LOW GRADE FEVER, PERSISTENT DRENCHING NIGHT SWEATS, BURNING BREAST AND CHEST PAIN WITH BREAST DISFIGUREMENT. CHRONIC INFLAMMATORY CHANGES. (*) (ALSO SEE 1008265, 1008266, 1008268).
RPTR HAD 7 AUGMENTATIONS FROM 1974 TO 1990. SIDE EFFECTS INCLUDED INFECTION, RUPTURE, CHRONIC PAIN AND FATIGUE, CHRONIC INFLAMMATION, SPEECH AND VISION PROBLEMS, DISCHARGE FROM NIPPLE, HUMAN ADJUVANT DISEASE, FIBROMYALGIA. ACCORDING TO A MEDICAL AND NEUROLOGIC EVALUATION 1/30/95: PT REPORTS BEING IN HER USUAL EXCELLENT STATE OF MEDICAL, NEUROLOGIC, AND PSYCHIATRIC HEALTH WHEN SHE CONSULTED THE DR FOR COSMETIC AUGMENTATION MAMMOPLASTY WITH INSERTION OF BILATERAL SILICONE GEL IMPLANTS. SHE DEVELOPED SOME IMMEDIATE DECREASED SENSATION IN THE NIPPLES, WHICH WITH TIME CHANGED TO A MILD HYPERSENSITIVITY. OTHERWISE, THERE WERE NO IMMEDIATE COMPLICATIONS FROM THIS SURGERY. HOWEVER, ONE WEEK LATER, PT WAS INVOLVED IN AN AUTOMOBILE ACCIDENT. SHE IMMEDIATELY DEVELOPED BURNING PAIN IN HER BREASTS, AND IMPLANTS WERE KNOCKED INTO NEW POSITIONS, WITH ONE OBVIOUSLY AT A DIFFERENT LEVEL THAN THE OTHER. NO IMMEDIATE RECONSTRUCTION WAS ATTEMPTED, WITH THE HOPE THAT WITH TIME IMPLANTS WOULD RELOCATE TO A BETTER POSITION ON THEIR OWN. HOWEVER, INSTEAD, BOTH IMPLANTS HARDENED MARKEDLY, ESPECIALLY ON THE RIGHT, AND DID NOT IMPROVE IN PLACEMENT. DUE TO THE UNACCEPTABLE HARDENING AND PLACEMENT, PT WAS REOPERATED IN 1975, WITH FINDINGS OF BILATERAL IMPLANT RUPTURE. NEW IMPLANTS WERE PLACED AT THAT TIME. SHORTLY THEREAFTER, BOTH IMPLANTS HARDENED, ESPECIALLY ON THE RIGHT, AND SEVERAL CLOSED CAPSULOTOMIES WERE PERFORMED, WHICH EVENTUALLY SOFTENED THE LEFT IMPLANT, BUT COULD NOT EFFECTIVELY SOFTEN THE RIGHT ONE. IN 1978, THE RIGHT IMPLANT AND EXTENSIVE SCAR TISSUE WERE REMOVED AND A NEW IMPLANT PLACED ON THE RIGHT. THIS IMPLANT AGAIN MARKEDLY HARDENED AND WAS REPLACED AGAIN IN 1979, 1982, AND 1982, WITH SEVERE RE-HARDENING AND PAIN EACH TIME. STINGING AND BURNING PAINS IN THE CHEST AND BREAST AREAS PERSISTED. BETWEEN 1985 AND 1990, THERE WAS AGAIN SEVERE RE-HARDENING ON THE RIGHT "LIKE A ROCK." IN 1990, PT HAD BOTH IMPLANTS REMOVED AND NEW IMPLANTS PLACED. IN ADDITION TO THE HARDENING, PT DEVELOPED A RIGHT NIPPLE DISCHARGE FROM THE LATE 1970S UP UNTIL THE 1990 SURGERY. WITH REGARDS TO THE MEDICAL CONDITIONS AND CHARACTERISTICS OUTLINE OF DEFINITIONS AND CLASSIFICATION CRITERIA TO THE GLOBAL RESOLUTION OF BREAST IMPLANT CLAIMS, THE PT INITIALLY MET AT LEAST FIVE CRITERIA FOR CATEGORY ATYPICAL CONNECTIVE TISSUE DISEASE/ATYPICAL RHEUMATIC SYNDROME/NON-SPECIFIC AUTOIMMUNE CONDITION BY 1975. SHE HAS MANIFESTED THE FOLLOWING CRITERIA: POLYARTHRALGIAS, POLYMYALGIAS, IMMUNE MEDIATED SKIN CHANGES, PULMONARY SYMPTOMS WITH FREQUENT UPPER RESPIRATORY INFECTIONS, MEMORY AND CONCENTRATION PROBLEMS, HEADACHES, PANIC ATTACKS, PARESTHESIAS, AND HEMIFACIAL SPASM, CHRONIC FATIGUE, ALOPECIA, SLEEP DISTURBANCES, SUSTAINED BALANCE PROBLEMS, EASY BRUISABILITY, COLITIS/IRRITABLE BOWELS, PERSISTENT LOW GRADE FEVER, PERSISTENT DRENCHING NIGHT SWEATS, BURNING BREAST AND CHEST PAIN WITH BREAST DISFIGUREMENT. CHRONIC INFLAMMATORY CHANGES. (*) (ALSO SEE 1008265, 1008266, 1008267).
FEMORAL VENOUS CATHETER INSERTED IN PREPARATION FOR CARDIAC SURGERY. USING STANDARD GUIDEWIRE TECHNIQUE THE CATHETER WAS SUCCESSFULLY CANNULATED AND THREADED. AFTER THE CONNECTING THE INTRAVENOUS FLUID TO THE HUB OF THE CATHETER, THE CATHETER SEPARATED FROM THE HUB, DISAPPEARING UNDER THE SKIN. A CUTDOWN WAS NECESSARY TO RETRIEVE THE CATHETER AND THE CARDIAC PROCEDURE WAS ABORTED.
AN INCREASE IN LINE RELATED INFECTIONS WAS NOTED IN PEDIATRIC HEMATOLOGY ONCOLOGY PTS IN 10/95 THE INTRODUCTION OF THE NEEDLELESS SYSTEM THE PREVIOUS MONTH WAS THE ONLY APPARENT NEW FACTOR IN THE PTS' CARE. HOSP  CEASED USING THE PRODUCT; PRELIMINARY DATA SHOWS THAT INFECTION RATES HAVE RETURNED TO BASELINE. AN ADD'L SAFETY CONCERN WAS THAT CHILDREN WERE REMOVING THE BLUE END CAP AND PUTTING IT IN THEIR MOUTHS. THE ADULT INPATIENT RATE OF LINE RELATED INFECTIONS ROSE FROM AN AVERAGE OF 7 PER MONTH IN JANUARY TO JUNE 1995 TO AN AVERAGE OF 14 PER MONTH IN JULY THROUGH OCTOBER, 1995. THE INTRODUCTION OF THE NEEDLELESS SYSTEM WAS THE ONLY APPARENT NEW FACTOR IN THE PTS' CARE AND HAD BEEN INTRODUCED IN JULY OF 1995. CEASED USING THE PRODUCT.
HEPARIN DRIP HUNG AND TUBING PLACED THROUGH CASSETTE. TUBING ATTACHED TO PT, BUT PUMP YET NOT TURNED ON. THIRTY MINUTES LATER, ENTIRE IV BAG NOTED TO HAVE INFUSED.
GLOVES USED DURING ORTHOPEDIC PROCEDURE ON LATEX SENSITIVE PT. WHEN GLOVES CAME IN CONTACT WITH BONE CEMENT, GLOVES DISINTEGRATED. NO KNOWN INJURY.
ON 3/17/95 A DOUBLE LUMEN CUFFED CENTRAL VENOUS LINE WAS PLACED VIA LEFT SUBCLAVIAN VEIN. ON 7/31/95 DURING REMOVAL, THE CATHETER BROKE OFF PERIPHERAL TO THE CUFF SITE WITH THE CUFF REMAINING IN THE SUBCUTANEOUS TISSUES INFERIOR TO THE CLAVICLE. THE CATHETER PIECE WAS REMOVED SURGICALLY.
ON 9/23/95 A CENTRAL VENOUS CATHETER WAS PLACED IN LEFT SUBCLAVIAN VEIN. ON  10/6/95 CENTRAL VENOUS LINE WAS PULLED. THE ENTIRE CATHETER CAME OUT WITH THE CUFF STILL IN PLACE. ON 10/12/95 CUFF AND 1 CM SEGMENT OF LINE SURGICALLY REMOVED.
ON 12/13/94 A BUTTON PORT CATHETER PLACED IN RIGHT SUBCLAVIAN VEIN. ON 11/6/95 LINE REMOVAL ATTEMPTED. PORTION OF CATHETER FROM PORT TO CUFF WAS REMOVED AND DISTAL END OF CATHETER RETAINED IN PT. ON 11/7/95 PT TRANSFERRED TO ANOTHER FACILITY FOR REMOVAL OF RETAINED CATHETER.
DURING THE RADICAL PROSTATECTOMY PROCEDURE, THE CLIP APPLIERS WERE CUTTING INSTEAD OF LIGATING. A TOTAL OF THREE (3) CLIP APPLIERS WITH THIS PROBLEM WERE FOUND IN THIS SINGLE PROCEDURE.
THE LENS WAS EXPLANTED FROM THE RIGHT EYE ON 11/28/95. THE 82 YR OLD FEMALE PT COMPLAINED OF CLOUDY VISION IN HER RIGHT EYE WHERE SHE HAD A LENS IMPLANTED A MONTH EARLIER. UPON EXAMINATION, THE OPHTHALMOLOGIST OBSERVED HAZINESS ON THE LENS. THE MFR WAS CONTACTED AND WAS INFORMED OF THE CASE. MFR STATED THAT SIMILAR COMPLAINTS HAVE BEEN REPORTED NATIONWIDE AND RECOMMENDED THE LENS BE EXPLANTED. THE LENSES WERE EXPLANTED.
BLOOD WAS NOTED IN THE INTRA-AORTIC BALLOON (IAB) ON 11/19/94. THE PT WENT TO THE OPERATING ROOM FOR REMOVAL OF IAB AND REPAIR OF RIGHT TEMPORAL ARTERY. THE PT HAD COMPLICATIONS WITH FOUR INTRA-AORTIC BALLOONS DURING HER STAY BUT ONLY ONE OF THE BALLOONS WAS SAVED. ACCORDING TO THE PT CHART, THE FIRST INTRA-AORTIC BALLOON (34CC) WAS PLACED AT 16:35 ON 11/12/94 AND WAS REMOVED AT 19:00 ON 11/14/94. A 40CC BALLOON WAS THEN INSERTED. THE 40CC BALLOON WAS NOTED TO HAVE BLOOD IN THE TUBING ON 11/15/94 AT 14:41 SO THIS IAB WAS ALSO REPLACED. ON 11/16/94 AT 11:55 ANOTHER IAB WAS PLACED BUT THERE WAS NO MENTION IN THE CHART AS TO WHY. FINALLY, ON 11/19/94 THE PT WENT TO THE OPERATING ROOM AT 7:15 FOR REMOVAL OF FINAL IAB UNDER DIRECT VISUALIZATION AS WELL AS FOR REPAIR OF RIGHT FEMORAL ARTERY. THE PT'S ARTERIES WERE DESCRIBED AS "VERY CALCIFIED, DIFFUSELY DISEASED, SMALL VESSELS" IN THE OPERATING ROOM REPORT.
DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF LEFT ILIAC ARTERY, ANGIOPLASTY BALLOON BURST, LEAVING PART OF THE BALLOON IN PT'S ARTERY. "AFTER BALLOON DILATATION OF 9MMX4CM BALLOON, BALLOON RUPTURED AT SUBMAXIMUM PRESSURE WITH SMALL FRAGMENT OF BALLOON LEFT ON VASCULAR CLIP 0 WHICH IS MOST LIKELY ENDOVASCULAR IN LOCATION. A 30MM STENT WAS PLACED OVER THE STENOSIS AND FRAGMENT DILATED TO 8MM. NO PRESSURE GRADIENT WAS MEASURED. LEFT DP PULSE NOW MEASURE 3+ BY PALPATION.
DURING PTCA OF PROXIMAL LAD THE DISTAL PORTION OF A BALLOON EXPANDABLE STENT SEPARATED AND REQUIRED REMOVAL OF THE FRAGMENT FROM THE RIGHT ILIAC ARTERY.
A PT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON 10/26/95. PT WAS STARTED ON P.C.A. FOR PAIN CONTROL. AT 2:00PM FETANYL 2MCG/CC AND BUPUROCAN 0.062 WAS 4:00PM THE PT COMPLAINED OF FEELING LIGHT HEADED. A CHECK OF THE INFUSION PUMP READ OUT REVEALED 560CCS OF FLUID HAD INFUSED. THE DISPLAY READOUT ON THE PUMP INDICATED THE FLUID WAS BEING INFUSED AT 15CC/H. THE PUMP WAS TURNED OFF AND REPLACED. THE INVOLVED INFUSION PUMP WAS TAKEN OUT OF SERVICE AND RETURNED TO THE MFR. THE PT SUFFERED NO SEQUELAE.
AT 2:45AM THE VENTILATOR MALFUNCTIONED AND WENT INTO AN EMERGENCY BACK-UP MODE OF PRE-SET PARAMETERS. THE VENTILATOR ALARMED AND THE NURSE IMMEDIATELY AMBUED THE PT. THE VENTILATOR WAS REPLACED AND SEQUESETERED IN THE RESPIRATORY DEPARTMENT. THE PT WAS AMBUED FOR TEN MINUTES AND SUFFERED NO INJURY. A CHECK OF THE ELECTRICAL OUTLET REVEALED ADEQUATE VOLTAGE WAS BEING SUPPLIED. A CHECK OF THE VENTILATOR BY CO REVEALED THREE SOFTWARE ERRORS CAUSED THE VENTILATOR MALFUNCTION. THE SOFTWARE WAS REPLACED AND THE VENTILATOR WAS TESTED AND PASSED. THE VENTILATOR HAS BEEN RETURNED TO SERVICE.
A 74 YR OLD IN E.R. WITH CHEST PAIN. INITIALLY GIVEN SL NTG WITH RELIEF. WAS BEING MONITORED ON CARDIAC MONITOR. PT WENT INTO V-FIB AND ARRESTED. CARDIAC MONITOR DID NOT ALARM BUT SITUATION DETECTED BY STAFF IMMEDIATELY. THE PT WAS SUCCESSFULLY RESUSCITATED/CARDIOVERTED. DIAGNOSED WITH AN MI. HOSPITALIZED FOR 7 DAYS AND DISCHARGED HOME. BIOENGINEERING INSPECTION OF MONITOR DETERMINED VOLUME OF ALARM ON LOW SETTING AND ALARM IN OFF POSITION AS A RESULT OF A POWER FLUCTUATION.
DURING CARDIAC SURGERY, PHYSICIAN ATTEMPTED TO PLACE AN IABP CATHETER INTO PTS LEFT GROIN. THE GUIDE WIRE WAS PLACED WITH SOME RESISTANCE. THE INTRODUCER WAS PLACED OVER WIRE BUT WAS UNABLE TO BE ADVANCED DUE TO MORE RESISTANCE. SECOND, INTRODUCER WAS TRIED BUT MET WITH SEVERE RESISTANCE. GUIDEWIRE WAS THEN WITHDRAWN WITH MODERATE RESISTANCE AND APPEARED TO HAVE "UNRAVELED" WITH OUTER WRAPPING SEPARATED FROM INNER WIRE. APPROX. 5CM PORTION OF GUIDEWIRE TIP WAS DISSECTED FROM GROIN. PT APPEARS IN STABLE CONDITION.
THIS 52 YR OLD FEMALE HAD AN OPEN REDUCTION, INTERNAL FIXATION OF THE LEFT FOREARM ON 8/29/95. ON SEPTEMBER 26, 1995 THE HARDWARE HAD TO BE REMOVED DUE TO BREAKAGE. A NEW DEVICE WAS IMPLANTED AT THAT TIME.
PICKED UP NEEDLE USER BOX AND WAS STUCK BY A LARGE PICK NEEDLE ON THE LEFT SMALL FINGER. A #18 NEEDLE ON 60CC SYRINGE, PUNCTURED PLASTIC WITH CLEAR LIQUID IN IT.
DURING "CODE" DEFIBRILLATOR DID NOT DISCHARGE WHEN USED AT 20 & 50 JOULES.
DR NOTIFIED AT END OF OPERATION THAT LAPAROSCOPE WAS NOT STERILE. CHEMICAL STILL IN ITS CONTAINER. DR. WAS TOLD AS SOON AS THIS WAS DISCOVERED. PT HAD ANTIBIOTICS PRE-OP. INDICATOR STRIP ALSO HAD NOT TURNED WHITE TO REPRESENT STERILIZING PROCESS. MFR REP WAS NOTIFIED AND CAME IN TO EXAMINE THE EQUIPMENT. IT IS BELIEVED THAT THE INSTRUMENTS WERE DISINFECTED IN THE MACHINE. INFECTION CONTROL INVOLVED IN THE FOLLOW-UP.
PT HAD EPIDURAL CATHETER IN PLACE FOR PAIN MANAGEMENT. UPON REMOVAL, DR NOTED TIP OF CATHETER APPEARED TO BE MISSING. X-RAY ORDERED SHOWS TIP IN SUBCUTANEOUS TISSUE. PT. SCHEDULED FOR LOCAL (SURGERY) FOR REMOVAL. NO COMPLICATIONS. PT TOLERATED PROCEDURE. DISCHARGED TO HOME.
FPTR NOTED THAT THERE SEEMS TO BE SOME FIBROUS MATERIAL (HAIR-LIKE) ON THE RUBBER PART OF THE PLUNGER.
A STANDARD OCCLUSION BALLOON CATHETER TESTED OUTSIDE THE PT AND THEN INSERTED INTO THE INTERNAL CAROTID ARTERY. THE BALLOON RUPTURED AND THE DEVICE WAS REMOVED. THE PT EXPERIENCED A NEUROLOGICAL EPISODE, WHICH COMPLETELY RESOLVED. THIRTY MINUTES LATER A SECOND BALLOON CATHETER WAS TESTED OUTSIDE THE PT AND INSERTED INTO THE INTERNAL CAROTID ARTERY. THE BALLOON RUPTURED UPON INFLATION. THE DEVICE WAS REMOVED AND THE PT EXPERIENCED ANOTHER NEUROLOGICAL EPISODE. SYMPTOMS INCLUDED FACIAL DROOPING, AND LEFT HEMIPARESIS. THE PROCEDURE WAS TERMINATED. THE PT'S SYMPTOMS GRADUALLY SUBSIDED. THE CATHETERS WERE THREE YRS OLD. THERE WERE NO EXPIRATION DATES ON THE CATHETER PACKAGING. ALL CURRENT CATHETERS HAVE EXPIRATION DATES ON THE PACKAGING.
SAFETY CAP WAS NOT IN PLACE ON NEEDLE. NEEDLE PIERCED PLASTIC BAG AND INJURED CAREGIVER. CO WAS NOTIFIED OF THE PROBLEM AND WAS SENT A SAMPLE.
BECAUSE A NURSE USED A TUBERCULIN SYRINGE AND THE MINIM SCALE TO ADMINISTER INSULIN, AN ELDERLY MALE PT RECEIVED 90 UNITS INSTEAD OF 14. RPTR RECOMMENDED DOING AWAY WITH THE MINIM SCALE.
THE RPTR STATES THE PHYSICIAN REPORTED A WHITE, GLOBULAR STRINGY SUBSTANCE OBSERVED UNDER THE MICROSCOPE AFTER INJECTION OF THE PRODUCT DURING CATARACT SURGERY. THE RPTR IS VERY CONCERNED THE PRODUCT MAY HAVE BEEN CONTAMINATED.
THE CAP WAS NOT INTACT; THE CATHETER POPPED OUT OF THE PACKAGE DURING OPENING AND STUCK THE PT. CO WAS NOTIFIED OF THE INCIDENT.
THIS IS AN ELBOW ADAPTER THAT IS USED TO BLEED OXYGEN INTO PT CIRCUITS AND TO MONITOR DELIVERED PRESSURES. ITEMS FROM LOT NUMBERS HAVE BEEN FOUND TO HAVE AN OCCLUSION AT THE 90 DEGREE BEND OF THE ELBOW. THIS IS A REPETITION OF THE SAME PROBLEM WHICH OCCURRED ON 8/4/95 AND 9/14/95 AND WHICH WAS REPORTED TO THE MFR. EVENT DATE REPORTED AS 12/1/95 TO 12/18/95.
A 9 1/2 PIECE OF CATHETER GUIDE WIRE DISCOVERED IN PTS ARTERY ON ROUTINE X-RAY. CATHETER HAD BEEN INSERTED INTO PT ON 7/18/95. ON 7/23/95 WIRE WAS REMOVED DURING RADIOLOGIC PROCEDURE USING A CATHETER AND A SNARE.
COMPLAINANT HAD SCREW INSTRUMENTATION (PLATES, BOLTS, SCREWS) IMPLANTED IN 1/88 TO CORRECT/RELIEVE STENOSIS IN A VERTEBRA OF HIS LOWER BACK. DEVICE WAS IMPLANTED THORACICALLY (IN FROM THE FRONT AND PLACED ON INSIDE OF SPINE). THE OPERATION DIDN'T WORK AND THE PT HAS HAD PROBLEMS EVER SINCE (PAIN AND LOSS OF MOBILITY). PROBLEMS HAVE BECOME WORSE LATELY, WHICH HAS CAUSED PT TO CONTACT FDA. THE COMPLAINANT THINKS THAT THIS MAY HAVE BEEN AN "UNAPPROVED" PROCEDURE, AND PT ALSO DOESN'T BELIEVE HE WAS WELL-INFORMED BY HIS PHYSICIAN.
IV THERAPY DISCONTINUED. UPON REMOVAL OF IV CATHETER, 1/4" OF CATHETER REMAINED INTACT. X-RAYS IDENTIFIED 2.2 CM IV CATHETER IN SOFT TISSUE OF LEFT ARM. PT WAS TAKEN TO SURGERY AND CATHETER WAS SUCCESSFULLY REMOVED ON 10/7/95.
FEEDING-TUBE INSERTED ON 10/23/95. ON 11/2/95 UPON REMOVAL, A 4-5 INCH SECTION OF TUBE WAS MISSING. X-RAY CONFIRMED 5 INCH PIECE OF TUBE IN STOMACH. BROKEN OFF SECTION OF TUBE REMOVED FROM STOMACH DURING A GASTROSCOPY PROCEDURE.
AFTER RECEIVING THE IMPLANT FOR HERNIATED DISK THE COMPLAINANT EXPERIENCED REDUCED BOWEL AND BLADDER CONTROL (LOST CONTROL 4-5 TIMES PER MONTH AT NIGHT), CHRONIC PAIN AT IMPLANT SITE, REDUCED JOINT AND HIP MOVEMENT, REDUCED PROFICIENCY IN ROUTINE ACTIVITIES. SHE IS BEDRIDDEN MOST OF EACH DAY AND IS UNABLE TO TOLERATE SEX.
THE CANNULA PORTION OF A 0.5ML SYRINGE DISSCONNECTED FROM THE SYRINGE WHILE IT WAS IN THE ANTERIOR CHAMBER OF THE PT'S RIGHT EYE DURING A PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANT. THE CANNULA PUNCTURED AN AREA BEHIND THE IRIS CAUSING VITREOUS LOSS FROM THE EYE. A SUBTOTAL VITRECTOMY WAS THEN NECESSARY FOR THIS PT.
ARTERIAL HEADER OF DIALYZER LEAKED BLOOD ONE HR INTO TREATMENT. NO ADVERSE PT OUTCOME.
RPTR RECENTLY EXPERIENCED A SEVERE RESPIRATORY INFECTION AND HIS PHYSICIAN PUT HIM ON HOME OXYGEN. THE PLASTIC TUBES FURNISHED WITH THE EQUIPMENT TO DELIVER THE OXYGEN (BY NASAL CANNULA) CAUSED SEVERE IRRITATION TO HIS BRONCHIAL TUBES, HIS UPPER LIP AND HIS MOUTH. IT RESULTED IN SEVERE ASTHMATIC PROBLEMS AND HE WAS FORCED OFF THE OXYGEN AS A RESULT. NEEDLESS TO SAY, THIS CAUSED HIM GREAT DISCOMFORT. HE HAS COPD AND IS VERY CONCERNED THAT SOME TIME IN THE FUTURE HE WILL REQUIE LIFE-SAVING ADMINISTRATION OF OXYGEN AND MAY BE UNABLE TO TOLERATE IT BEING DELIVERED THROUGH THESE TUBES. THE CHEMICAL ODORS FROM THESE TUBES WERE SO PERVASIVE THAT RPTR HAD TO REMOVE THEM ENTIRELY FROM THE HOUSE AS THE FUMES WERE AFFECTING OTHER FAMILY MEMBERS. HE FINDS IT EXTREMELY HARD TO BELIEVE THAT HE IS THE ONLY PERSON EVER TO HAVE SUFFERED SUCH AN ALLERGIC REACTION. LAST FEBRUARY HE WAS HOSPITALIZED FOR A MILD HEART CONDITION AND OXYGEN WAS DELIVERED BY NASAL CANNULA WITH NO ODORS OR ILL EFFECT.
WHEN THE NURSE PLUGGED THE FORCEPS INTO THE MACHINE THE MONO COAG MODE WAS IMMEDIATELY ACTIVATED (COAG SETTING 41 WATTS, CUT SETTING 0 WATTS), CAUSING THE FORCEPS TO BECOME ACTIVATED WHICH WAS IN CONTACT WITH THE PT'S CHIN CAUSING A BURN. SUBSEQUENT INVESTIGATION SHOWED THAT THIS CONDITION COULD BE DUPLICATED BY SIMULTANEOUSLY PLUGGING THE LEAKS OF THE FORCEPS INTO THE  BLUE AND RED OUTPUT JACKS OF THE MONOPOLAR HAND CONTROL OUTLETS. TESTS PERFORMED ON THE ELECTRICAL SURGICAL GENERATOR AND BIPOLAR FORCEPS SHOWED NO MALFUNCTION OR DEFECT IN EITHER UNIT.
A WOMAN LIVING WITH HER FRIENDS, HAVING JUST 2 WEEKS AGO MOVED FROM CALIFORNIA, GOT 2ND DEGREE BURNS ON THE FRONT SIDE OF HER BODY (FACE, BREASTS, & LEGS) AFTER A 10 MINUTE TREATMENT IN A SUNTAN BOOTH. SHE IS NOW PEELING ON THE FACE AND BREASTS. IN CALIFORNIA SHE HAD SUN TANNING TREATMENTS DAILY AND THERE THERE WAS A 1 WEEK LAPSE BEFORE THE TREATMENT ON 9/13/95. SHE HAD NEVER EXPERIENCED BURNS OR PEELING BEFORE. SHE FELT VERY HOT AFTER THE 10-MINUTE TREATMENT, BUT DIDN'T FEEL THE BURN UNTIL LATER IN THE DAY. SHE WENT TO THE ER AND WAS GIVEN CREAM FOR THE BURNS. SHE DID NOT TELL THE SALON ABOUT THE BURNS, BUT SAYS SHE WON'T GO BACK. HER FRIENDS TOLD HER TO CALL FDA WHO COULD DO SOMETHING ABOUT IT. INSIDE THE SUNTAN BOOTH SHE REMOVED ALL HER CLOTHES AND LAID ON HER BACK IN A BED COVERED WITH AN ACRYLIC PLEXI (SHIELD) OVER THE LIGHT BULBS. SHE SAID, HOWEVER, THAT THE LIGHT BULBS FROM ABOVE DID NOT HAVE THE ACRYLIC PLEXI COVERING THE BULBS HAD. THE TIME WAS SET BY THE PEOPLE OUTSIDE THE BOOTH. SHE DID WEAR GOGGLES AND AFTER A DAY OR SO THE PAIN WENT AWAY.
ATTEMPTED PICC LINE INSERTION, RIGHT ARM, UNSUCCESSFUL. ONLY ABLE TO REMOVE 17 INCHES OF 20 INCH CATHETER. X-RAY TAKEN, DISTAL END OF CATHETER COILED IN VEIN. CATHETER SURGICALLY REMOVED BY CUT-DOWN PROCEDURE.
SURGEON USED CAUTERY DURING A TONSILECTOMY. WHILE CAUTERIZING IN THE PT'S MOUTH, THE CAUTERY ARCED DUE TO A BREAK IN THE INSULATION, CAUSING A SMALL  BURN ON PT'S LIP.
UPON DEFIBRILLATION OF PT, THE MONITOR TRACING DISAPPEARED. A DIGITAL READOUT REMAINED. THE DEFIBRILLATOR HAD BEEN UTILIZED NUMEROUS TIMES THAT DAY. THE PT HAD A THERMODILUTION CATHETER AND AN ARTERIAL LINE IN PLACE. ON VENTILATOR. PT MOVED TO ANOTHER ROOM. DISTRIBUTOR HERE TO EXAMINE EQUIPMENT. DISTRIBUTOR COULD NOT DUPLICATE PROBLEM.
RPTR SENT COPY OF A LETTER FROM A PHD STATING, "I HAVE DETAILED MY INITIAL FINDING FROM THE 8 MILLILITERS (ML) FROZEN SAMPLE OF CEREBROSPINAL FLUID (CSF) RECEIVED BY OUR LABORATORY FROM HOSPITAL CENTER DOCTOR. IN LATE MAY I RECEIVED AN APPROXIMATELY 8 ML SAMPLE OF FROZEN CSF. AFTER APPROXIMATELY 2 WEEKS I ATTENDED TO THE SAMPLE BY BRINGING IT TO ROOM TEMPERATURE, DECANTING 5ML FROM THE PLASTIC TEST TUBE AND EXTRACTING THE SAMPLE WITH SPECTROSCOPY GRADE HEXANE. THE EXTRACTED SOLUTE WAS ANALYZED BY INFRARED SPECTROSCOPY PRODUCING THE SPECTROGRAMS ENCLOSED HEREWITH. INDICATIONS OF THE PRESENCE OF SILICONE RUBBER IN THE CSF FLUID ARE DEDUCED FROM THE APPEARANCE OF CORRESPONDING PEAKS IN THE SPECTROGRAMS OF PURE SILICONE (CONTROL) AND THE CSF SAMPLE (1445 V 1460, 1255 V 1259,9, 1090.5, 1014.1 V 1017.0, 864.3 V 867.2, 797.6 V 796.7)." RPTR STATED SHE HAS NOW HAD A SECOND TEST ON THIS FLUID PER A DOCTOR AT ANOTHER MEDICAL CENTER. SHE STATES IF THIS REPORT IS TRUE THEN IT COULD PROVE THAT SILICONE DOES CROSS THE BLOOD/BRAIN BARRIER AND WOULD ALSO PROVE CAUSATION. (*)
RPTR HAS HAD NUMEROUS COMPLAINTS FROM CUSTOMERS THAT BOTH THEIR PHYSICIANS AND THE HOSP LAB HAVE CHECKED THE STRIPS AND FOUND THEM NOT TO BE ACCURATE. (*)
FOAM FROM HEAT AND MOISTURE EXCHANGER (HME) HME FILTER AND GOT CLOGGED IN SUCTION CATHETER BETWEEN ENDO TUBE CAUSING THE VENTILATOR TO HIGH PRESSURE. PT WAS REMOVED FROM VENTILATOR AND BAGGED. SUCTION CATHETER WAS REPLACED AND PT WAS PLACED BACK ON THE VENTILATOR WITH NO PROBLEMS.
BAG PUNCTURED BY BEING FOLDED ON ITSELF OVER THE TUBING PARTS.
AFTER BEING ON UNIT FOR SIX TO SEVEN MINUTES, PT. HEART RATE/RHYTHM WENT FROM PACER/SINUS TO VENTRICULAR STAND STILL. PT WAS COMPRESSD FOR APPROX TEN SECONDS AND CONSCIOUSNESS RESTORED. INSPECTION OF PACER/PACER CABLE REVEALED THAT EVEN AFTER SECURING DEVICE THAT RECEIVES CABLE WAS TIGHTENED, THE CABLE PROBE EASILY FELL OUT. ALSO, WHEN DR ARRIVED SHORTLY AFTER OCCURRENCES, HE ADVANCED THE ELECTRODE 1" INTO THE PT FELT THAT POSSIBLY CONTACT WAS NOT GOOD AND THAT THIS MAY HAVE CONTRIBUTED TO THE ABOVE VENTRICULAR STAND STILL.
THE INSTRUCTIONS FOR USE OF THE TEST STRIPS SPECIFICALLY INSTRUCT THE PT OR USER NOT TO HANDLE STRIPS. OFTEN A TEST DOES NOT WORK UNLESS A LARGE QUANTITY OF BLOOD IS PLACED ON THE STRIP. IF A SMALL DROP OF BLOOD IS USED THE PT MUST PRESS THE STRIP WITH THEIR FINGERS. THE INSTRUCTIONS ARE NOT CLEAR AND CONFLICT WITH INSTRUCTIONS GIVEN VERBALLY WHEN PT CONTACTS MFR BY TELEPHONE.
PT USED BEDSIDE COMMODE. UPON GETTING UP, COMMODE PINCHED OR CUT PT'S LEFT THIGH CAUSING LACERATION APPROX THE SIZE OF A QUARTER. LACERATION BLED.
INSULIN SYRINGE ARE DEFECTIVE. THE PLASTIC CAP COVERING THE NEEDLE LOOKS LIKE IT HAS MELTED, PRODUCING A RAISED CIRCLE. THE PT SAYS HE CUT HIS FINGER WHEN TRYING TO TAKE THE CAP OFF THE SYRINGE.
TUBING BETWEEN PT'S NOSE AND PENDANT RESERVOIR KINKED TOO EASILY. PT STATED HE WAS NOT GETTING ENOUGH OXYGEN. POTENTIAL HYPOXEMIA.
RPTR HAS HAD NUMEROUS COMPLAINTS FROM CUSTOMERS THAT BOTH THEIR PHYSICIANS AND THE HOSP LAB HAVE CHECKED THE STRIPS AND FOUND THEM NOT TO BE ACCURATE.
DEFECTIVE LEAD DISCOVERED WHEN PT HOOKED BY PHONE FOR READING. PROBLEM  RELATED TO DEFECT IN INSULATION OF LEAD.
PT UNDERGOING LEFT HIP ARTHROPLASTY. DR WAS USING THE TRIAL 12MM PLUG BEFORE INSERTING PERMANENT PLUG. THE HANDLE BROKE OFF PLUG REMAINING IN INSERTER. DR WAS UNABLE TO RETRIEVE THE TRIAL, PLUG WAS LEFT IN, CEMENT INSERTED AND THE PROCEDURE COMPLETED.
STRESS PROCEDURE FOLLOWED. COMPUTER APPEARED TO BE ACQUIRING STRESS IMAGES. HOWEVER, AFTER PT WAS SENT TO ROOM, TECHNICIAN ATTEMPTED TO PROCESS IMAGES. NO INFO OF PT WAS PRESENT. COMPUTER MALFUNCTION RESULTED IN PT RETESTING ON TREADMILL AND REINJECTIONS.
CATHETER INSERTED FOR RESIDUAL URINE. NO URINE CAME THRU. CATHETER REMOVED. URINE APPEARED TRAPPED IN CATHETER.
APPLYING STAPLER TO BOWEL FOR STAPLING. UNIT MISFIRED. PARTIAL STAPLES FIRED AND PARTIAL STAPLES REMAINED IN CARTRIDGE.
FLUID (918 CC) GIVEN AT 150 CC/HR. INFUSED IN 5 1/2 HRS. SHOULD HAVE BEEN 6 HRS. MACHINE REGISTERED 749 CC.
BILATERAL BREAST IMPLANT EXCHANGE WITH PARTIAL CAPSULECTOMIES.
ADMITTING DIAGNOSIS HIATAL HERNIA. PERFORMED LAP NISSAN ON 1/16/96. PT RETURNED TO SURGERY ON 1/18/96 FOR POST-OP BLEEDING. PT SENT TO CCU AND EXPIRED ON 1/19/96. THE SCALPEL WAS USED DURING THE LAP NISSAN AND ACCORDING TO PHYSICIAN, WORKED AS EXPECTED. HOWEVER, IT WAS SINGLED OUT FOR REVIEW BECAUSE IT WAS NEW AND BECAUSE IT WAS THE FIRST TIME THIS PHYSICIAN HAD USED IT. PHYSICIAN ATTRIBUTED CAUSE OF DEATH TO PANCREATITIS.
PT ADMITTED FOR EXTRACTION OF DEGENRATED ATRIAL PACEMAKER LEAD. ACCORDING TO MFR, LEAD HAD BEEN RECALLED. THE TRANSVENOUS EXTRACTION WAS COMPLICATED BY INTRA-OPERATIVE HEMORRHAGE REQUIRING MEDIASTERNOTOMY. ONE OF THE ELECTRODES WAS PENETRATING THE SUPERIOR VENA CAVA POSTERIOR OF THE LEVEL OF THE AZYGOUS VEIN AND WAS INTO THE RIGHT PLEURAL CAVITY. NUMEROUS UNITS OF BLOOD AND BLOOD COMPONENTS WERE TRANSFUSED. THE PT STABILIZED AND SENT TO THE SPECIAL CARE UNIT. (PER O.R. REPORT) PT EXPIRED SEVERAL HOURS LATER.
PT FOUND APNEIC AND PULSELESS. DIALYSIS CATHETER BROKEN OFF. PORTS AND APPROXIMATELY 3 INCHES OF ARTERIAL CATHETER LYING IN BED. SMALL AMOUNT OF BLOOD ON BED AND GOWN. CATHETER HAS BEEN SUTURED AT SKIN EXIT SITE.
PITOCIN WAS ORDERED TO INDUCE LABOR. PIT DRIP PLACED ON INFUSION PUMP AT 3.0 CC/HR. APPROX. 4 MIN AFTER PIT DRIP STARTED PT BEGAN A TETONIC CONTRACTION LASTING 5 MIN. IV THERAPY USED TO STOP CONTRACTION AND IV DISCONTINUED IMMEDIATELY. NURSE IN CONSTANT ATTENDANCE AND RECOGNIZED SIGNIFICANCE OF CONTRACTION. IV APPEARED TO RUN AT FREE FLOW RATE. BIOMEDICAL ENGINEERING CHECKED FLOW RATES ON BOTH CHANNELS PRIOR TO SENDING UNIT TO THE CO FOR QUALITY REVIEW CHECKS. PT DELIVERED SEVERAL HOURS LATER WITH INFANT APGAR SCORES OF 6/9. NO FURTHER PROBLEMS.
CATHETER PLACED BY ANESTHESIOLOGIST IN PREPARATION FOR CARDIO-THORACIC SURGERY. APPROX 5 MINUTES LATER PT HAD ONSET OF MASSIVE HEMOPTYSIS AND ARRESTED. CPR BEGAN IMMEDIATELY WITH INTUBATION/VENTILATION, EXTERNAL MASSAGE, MEDS, BLOOD TRANSFUSION, AND CHEST-TUBE PLACEMENT. CODE WAS UNSUCCESSFUL AND PT WAS PRONOUNCED DEAD. DEVICE NOT SAVED. PHYSICIAN STATES NO DEFECTS NOTED AT ROUTINE PRE-INSERTION INSPECTION. (*)
ON 12/25 THIS INFANT WAS ADMITTED TO THE EMERGENCY DEPARTMENT WITH RESPIRATORY DISTRESS. DURING TREATMENT A PROBLEM WITH THE INFANT RESUSCITATION UNIT WAS ENCOUNTERED. APPARENTLY THE YELLOW ONE WAY VALVE DID NOT OPEN TO ALLOW AIR TO PASS INTO THE ENDOTRACHEAL TUBE. SUSPECTING THAT THE PROBLEM WAS WITH THE PLACEMENT OF THE ENDOTRACHEAL TUBE, THE BABY WAS REINTUBATED 3 TIMES. AFTER THE 3RD INTUBATION A NEW BAG VALVE MASK WAS USED AND THE BABY WAS ABLE TO BE VENTILATED. AFTER THE INCIDENT THE ITEM WAS INSPECTED AND THE VALVE APPEARED TO BE STUCK SHUT. THE INFANT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER FACILITY FOR THE OTHER TREATMENT UNRELATED TO EQUIPMENT PROBLEM.
T8-L2 LAMINECTOMY, DEBRIDEMENT/IRRIGATION/DRAINAGE EPIDURAL ABSCESS. REMOVAL EPIDURAL CATHETER-LRG LIQUID ABSCESS POSTERIORLY AND EPIDURAL.
THIS 39 YR OLD FEMALE HAD BILATERAL BREAST IMPLANTS IMPLANTED IN 1985. THE PROCEDURE WAS PERFORMED AT ANOTHER FACILITY, THE MFR IS UNKNOWN TO THIS REPORTING FACILITY. THE PT HAS DONE WELL SINCE IMPLANTATION BUT RECENTLY DEVELOPED SEVERE ENCAPSULATION AROUND THE RIGHT BREAST IMPLANT SO THAT IT WAS RIDING UP AND DOWN. GROSS EXAM: THE RIGHT IMPLANT IS RUPTURED AND EXUDES GELATINOUS AND TENACIOUS GEL-LIKE MATERIAL. THE CAPSULE SHOWS FIBROSIS AND CHRONIC INFLAMMATION CHANGES.
THIS 48 YR OLD FEMALE UNDERWENT A BILATERAL AUGMENTATION MAMMOPLASTY IN 1970 WITH INSERTION OF SILICONE GEL BREAST IMPANTS. THIS PROCEDURE WAS PERFORMED AT ANOTHER FACILITY, THUS THE MFR IS UNKNOWN TO THIS REPORTING FACILITY. PT IS REPORTED TO HAVE DONE WELL WITH THE IMPLANTS UNTIL A MVA IN 1993 AT WHICH TIME SHE MAY HAVE RUPTURED THE IMPLANTS. A MRI DEMONSTRATES THE RUPTURE OF THE IMPLANT. GROSS EXAM: BOTH IMPLANTS ARE RUPTURED.
RESIDENT HAD BEEN PUT TO BED FOR THE NIGHT. SHE WAS PLACED IN A JACKET RESTRAINT WHICH ZIPPED UP THE BACK AND TIED TO THE FRAME OF THE BED ON BOTH SIDES OF THE BED WITH A QUICK RELEASE BOW. BOTH FULL LENGTH SIDE RAILS WERE PLACED IN AN UP POSITION. RESIDENT WAS YELLING "COME ON" PRIOR TO BEING PUT TO BED AND CCONTINUED AFTER SHE WAS IN BED. RESIDENT ROUNDS WERE MADE PER PROCEDURE. A STAFF MEMBER CHECKED IN ON RESIDENT AND APPROX FIVE MIN LATER  NOTED RESIDENT WAS QUIET. STAFF MEMBER WENT TO CHECK ON RESIDENT AND FOUND RESIDENT WITH HER HEAD AND ARM STUCK DOWN BETWEEN THE BED AND SIDE RAIL. STAFF MEMBER IMMEDIATELY CALLED FOR HELP AND IMMEDIALTELY PROCEEDED TO DISLODGE THE RESIDENT.
X-RAY DONE TO CHECK PATENCY OF PORT (SITE LEAKING). FOUND CATHETER SEPARATED FROM THE PORT BODY. PT IN NO DISTRRESS. PORT AND CATHETER REMOVED SURGICALLY WITHOUT INCIDENT.
ON 12/10/95, A PT WAS ADMITTED INTO THE HOSP FOR A GUNSHOT WOUND TO THE BACK. FOLLOWING EXTENSIVE SURGICAL REPAIR OF THE INJURY, THE PT WAS ADMITTED TO THE TRAUMA SURGICAL INTENSIVE CARE UNIT AND WAS REPLACED ON A VENTILATOR. WITHIN AN HOUR OF ARRIVAL TO THE ICU, THERE WAS DIFFICULTY IN MAINTAINING ACCEPTABLE ARTERIAL OXYGEN SATURATIONS. THE PT REQUIRED CARDIOPULMONARY RESUSCITATION AND EVENTUALLY EXPIRED. THERE WAS CONCERN THAT THE VENTILATOR HAD MALFUNCTIONED. THE SEQUENCE OF EVENTS WAS AS FOLLOWS: PT ARRIVED TO TRAUMA SURGICAL INTENSIVE CARE UNIT FROM OPERATION ROOM AND PLACED UPON THE VENTILATOR. SETTINGS WERE: VT 800, F12, FI02 100%, PEEP 5. AT 0310 PT WAS NOTED AS HAVING FREQUENT PULSE OXIMETER DESATURATIONS. ARTERIAL BLOOD GASES WERE DRAWN. SETTINGS WERE CHANGED TO: VT 1000, F20,FI02 100%, PEEP 15. THE PT CONTINUED TO DESATURATE OFF AND ON DURING THIS PERIOD OF TIME. IT WAS NOTED AT 0325 THE VENTILATOR WAS FLASHING 21% OXYGEN. THE STAFF IMMEDIATELY BEGAN BAGGING THE PT WITH A RESUSCITATOR BAG WITH AN ATTACHED PEEP VALVE SET AT 15. AT THIS TIME, A RESPIRATORY THERAPIST ATTEMPTED TO TROUBLESHOOT THE PROBLEM BY TURNING THE VENTILATOR OFF AND ON. THE HIGH PRESSURE HOSES WERE ALSO TESTED. THE PANEL CONTINUED TO SHOW 21% OXYGEN. PT EXPIRED AT 0335. THE VENTILATOR CONTROL PANEL SHOWED THE MESSAGE THAT THE 02 WAS DISABLED. THE VENTILATOR WAS REMOVED FROM SERVICE UNTIL IT COULD BE CHECKED BY THE CLINICAL ENGINEERING DEPT AND UNTIL THE SAFETY WAS NOTIFIED. THE AUTOPSY REPORT STATED THAT THE PT'S DEATH WAS SECONDARY TO CARDIOVASCULAR COLLAPSE. THE PT'S DEATH WAS NOT FORMALLY ATTRIBUTED TO A MECHANICAL VENTILATOR MALFUNCTION. FACILITIES CLINICAL ENGINNERING DEPARTMENT CHECKED THE VENTILATOR AND TRIED TO DUPLICATE THE PROBLEM. THE PROBLEM COULD NOT BE DUPLICATED. FOLLOWING THE VISUAL AND MECHANICAL EVALUATION AND THE DISCUSSION WITH MFR, THE VENTILATOR WAS CLEARED FOR USE AND RETURNED TO SERVICE ON 12/15/95. ON 12/17/95, AGAIN THE VENTILATOR MALFUNCTIONED WHILE ON A PT. THE VENTILATOR HAD BEEN WORKING CORRECTLY THROUGHOUT THE DAY UNTIL AT 1700 THE ALARM SOUNDED AND A MESSAGE PF "LOW 02 INLET PRESSURE" WAS NOTED ON THE CONTROL PANEL. THE PT SATURATIONS DROPPED TO 84% BUT WERE IMMEDIATELY RECOVERED WHEN STAFF TOOK THE PT OFF THE VENTILATOR AND MANUALLY VENTILATED THE PT. THERE WERE NO ILL EFFECTS TO THIS PT. THE RESPIRATORY THERAPIST ATTEMPTED TO CORRECT THE PROBLEM AT THE BEDSIDE BUT THE VENTILATOR WOULD NOT DELIVER GREATER THAN 21% OXYGEN. THE VENTILATOR WAS REMOVED FROM SERVICE. ON 12/22/95, HOSP BIOMED CONDUCTED A 10,000 HOUR OVERHAUL OF THE UNIT. FOLLOWING THE OVERHAUL, THE VENTILATOR WAS PLACED BACK INTO SERVICE. NO PROBLEMS HAVE BEEN REPORTED SINCE IT WAS PUT BACK INTO SERVICE.
CATHETER CAME AWAY FROM PORT AND HAD TO BE SURGICALLY REMOVED. THIS WAS DONE AT ANOTHER HOSPITAL. DEVICE HAD BEEN INSERTED 7/26/95.
ON 6/16/95 ABOUT 1300, DEVICE CHANGED BECAUSE OF A POSITION PROBLEM (TOO SHORT). WHEN THE OLD TAPE WAS REMOVED A SEVERE SKIN BREAK DOWN WITH SOME BRUISING AND FRESH BLOOD WAS NOTED. SKIN PROTECTOR WAS APPLIED BEFORE REGULAR TAPE. ON 6/23/95 THE BABY WAS ASSESSED BY AN RN AT ABOUT 0300. RN NOTED TWO SMALL DROPS OF DRIED BLOOD ON CLOTH DIAPER UNDER BABY'S HEAD. THIS WAS THOUGHT TO COME FROM AREA WHERE E-T TUBE SECURED. PLASTIC SURGEON  SAW LATER IN A.M. ORDERED REMOVAL OF TAPE AND SKIN PROTECTOR. REMOVED CAREFULLY AND AREA CLEANSED WITH 1/2 STRENGTH H2O2 AND RINSED WITH STERILE WATER. WHEN REMOVED THE SKIN AND TISSUE CAME WITH THE SKIN PROTECTOR. VERY DEEP WOUND WAS OBSERVED. BABY DIED A FEW DAYS LATER FROM COMPLICATION OF PREMATURITY.
DURING BRONCHOSCOPY, LASER TREATMENT OF TUMOR ATTEMPTED. FIRE ERUPTED IN AIRWAY AFTER INITIAL FIRING OF LASERSCOPE.
DURING SURGICAL PROCEDURE ON PT'S KNEE, PART OF THE TUNING FORK AND A PIECE OF THE DRILL BIT BROKE OFF INSIDE THE PT'S LEFT KNEE (2 PIECES TOTAL). SURGEON ORDERED A PORTABLE X-RAY TO VERIFY THAT THE PIECES WERE IN THE KNEE. X-RAYS VERIFIED TWO SMALL FRAGMENTS OF INSTRUMENTATION HAD BEEN LEFT IN THE KNEE. SURGEON REPORTED THAT WITH THE ORTHOPEDIC RESIDENT DISCUSSED THE SITUATION WITH THE FAMILY. SURGEON STATES "FOREIGN BODIES WILL NOT CAUSE A PROBLEM AND WILL NOT BE REMOVED." THE INSTRUMENTATION REP WAS PRESENT DURING THE PROCEDURE AND IT IS BELIEVED HE SHOULD HAVE ADVISED THE SURGEON THAT THIS INSTRUMENT, WHICH WAS BEING USED FOR GRAFT PLACEMENT, WAS NOT INTENDED FOR THAT USE.
CAPSULAR CONTRACTURE. BREAST ASYMMETRY. SURGERY REQUIRED TO CORRECT PAINFUL BREAST CAPSULAR CONTRACTURE.
PT WAS BROUGHT TO ER AM OF 12/31/95 COMPLAINING OF HEADACHE AND N/V SHUNT SERIES OF X-RAYS WERE TAKEN AND IT WAS NOTED BY NEUROSURGEON THAT THE PLASTIC END OF SHUNT GOING INTO THE PUMP PART OF THE VP SHUNT ASSEMBLY HAD BROKEN AND SEPARATED, LOSING ITS CONTINUITY.
THE PT COMPLAINED OF ABDOMINAL PAIN POST COLONSCOPY. FLAT PLATE OF THE ABDOMEN DONE AND REVEALED FREE AIR. ON 12/15/95 PT HAD EXPLORATORY LAPAROSCOPY/LYSIS OF ADHESIONS/REPAIR OF PERFORATED COLON. AS OF 12/18/95 PT WAS NPO IN STABLE CONDITION.
THE PT WAS ADMITTED 24 HOURS POST COLONOSCOPY WITH COMPLAINT OF ABDOMINAL PAIN. X-RAYS SHOWED A SMALL TEAR IN THE COLON WHICH WAS TREATED WITH TPN. NO SURGERY WAS NEEDED. THE PT WAS DISCHARGED 12/12/95 IN STABLE CONDITION.
THROMBOSIS OF AORTIC VALVE PROSTHESIS REQUIRING EXPLANATION AND IMPLANTATION OF ANOTHER CO'S PERICARDIAL PROSTHESIS.
EXPANDER DEVELOPED 'LEAK' AND HAD TO BE REMOVED 1/12/96. M.D. TOOK PROSTHESIS TO GIVE TO MFR.
WHILE REPOSITIONING RESIDENT IN BED, SIDERAIL BECAME DISMANTLED. RESIDENT  FELL OUT OF BED ONTO THE FLOOR. NUT LOOSENED FROM BOLT HOLDING ATTACHMENT OF BEDRAIL TO BED.
DEFIBRILLATOR SET FOR 200 JOULES DID NOT FIRE. RESET FOR 200 JOULES AND THEN FIRED. 2ND TIME, THIS DEFIBRILLATOR HAS NOT DISCHARGED PROPERLY. PULLED FROM UNIT AND UNDERGOING INDEPENDENT EVALUATION.
PT RECEIVED SMALL CIRCULAR BURN AS A RESULT OF THE IONTOPHOREIC TREATMENT. THE BURN WAS CAUSED SECONDARY TO THE ELECTRODE CONTRACT WITH THE SKIN.
PT RECEIVED SMALL CIRCULAR BURN AS A RESULT OF THE IONTOPHOREIC TREATMENT. THE BURN HAS CAUSED SECONDARY TO THE ELECTRODE CONTACT WITH THE SKIN.
PT IS A 48 YR OLD WHITE FEMALE WHO IS STATUS POST (> 1 YR) RIGHT MODIFIED RADICAL MASTECTOMY AND RECONSTRUCTION WITH A EXPANDER IMPLANT. THE PT NOTED THE ONSET OF FEVER AND MALAISE ABOUT 3 DAYS PRIOR TO ADMISSION. TWO DAYS PRIOR TO ADMISSION SHE NOTED SWELLING, PAIN, AND WARMTH TO THE RIGHT BREAST. SHE WAS ADMITTED ON 12/18/95 AND UNDERWENT REMOVAL OF THE RIGHT BREAST IMPLANT, DRAINAGE OF ABSCESS AROUND THE RIGHT BREAST IMPLANT AND BIOPSY OF THE BREAST IMPLANT CAPSULE.
ACROMIOPLASTY ELECTRODE USED DURING ARTHROSCOPY OF LEFT KNEE. NO PROBLEMS WERE EXPERIENCED THROUGHOUT THE PROCEDURE. WHEN ELECTRODE REMOVED FROM CANNULA, IT WAS NOTED THAT THE TIP OF ELECTRODE WAS MISSING. DR VISUALIZED THE INSIDE OF KNEE WITH ARTHROSCOPE & IRRIGATED THE KNEE. CONTENTS OF  SPECIMEN TRAP FELT FOR ANY FOREIGN SUBSTANCE. NONE NOTED. SPECIMEN SENT TO PATHOLOGY. NO FOREIGN SUBSTANCES NOTED IN PATHOLOGY REPORT.
REMOVAL OF BILATERAL BREAST IMPLANTS THAT HAD RUPTURED INTO HUMAN CAPSULE.
IMPLANTED APPROX 1981. RUPTURED SILICONE IMPLANTS-BILATERAL BREASTS.
DURING PTCA WITH STENT PLACEMENT PROCEDURE, GUIDEWIRE AND BALLOON HAD  CROSSED LESION. WHEN ATTEMPTING TO REMOVE, GUIDEWIRE BROKE INSIDE BALLOON CATHETER. CATHETER AND GUIDEWIRE WERE REMOVED. PROCEDURE WAS RESTARTED WITH SAME TYPE OF GUIDEWIRE. WHEN ATTEMPTING TO EXCHANGE GUIDEWIRE, TIP SEPARATED FROM MAIN GUIDEWIRE AND WAS UNABLE TO BE RETRIEVED.
DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM WITH DRAINAGE PROCEDURE, THE MANDRILL GUIDE WIRE WAS INSERTED INTO THE NEEDLE. THE NEEDLE WAS MOVED SIDE TO SIDE AND THE WIRE WAS PULLED BACK. THE END OF THE WIRE CAME OFF AND IS LODGED IN OR NEAR THE LIVER. PROCEDURE WAS BEING PERFORMED IN RADIOLOGY DEPT.
AFTER PT HAD BEEN ON DIALYSIS FOR 1 HR, WHEN MAKING ROUTINE DIALYSIS UNIT ROUNDS, THE DIALYSIS CARE GIVER NOTED A SMALL AMOUNT OF DRIED BLOOD ALONG THE TOP OF THE HEADER OF THE HEMODIALYZER BEING USED FOR THAT TREATMENT. DIALYSIS WAS DISCONTINUED AND RESTARTED WITH NEW DIALYZER AND BLOOD TUBING. PHYSICIAN WAS NOTIFIED. BLOOD CULTURES (2 SETS) WERE DRAWN. ON OBSERVATION, A CRACK WAS DISCOVERED ALONG THE FEMALE LUER CONNECTOR AT THE TOP OF THE  DIALYZER (WHERE THE BLOOD TUBING IS CONNECTED).
CHEMOTHERAPY DRUG-TAXOL-INFUSION UTILIZING INFUSION PUMP. NURSE NOTICED FLUID INFUSING TOO RAPIDLY AND TURNED PUMP OFF AND FLUID CONTINUED TO INFUSE WITH THE TUBING IN THE PUMP WITH SLIDE CLAMP IN PLACE. NEW INFUSION PUMP  OBTAINED-BUT DRUG INFUSED 4-6 HOURS EARLIER THAN SCHEDULED.
PT WENT FROM MULTIPLE PVCS TO TORSADE V-TACH AND THEN V-FIB. MONITOR FAILED TO ALARM FOR V-TACH OR V-FIB. PT REQUIRED DEFIBRILLATION TO RESTORE NORMAL RHYTHM.
PT HAD BILATERAL AUGMENTATION MAMMOPLASTY APPROX 4 YRS AGO. SHE DEVELOPED BILATERAL GRADE IV CAPSULAR CONTRACTURES. RECENTLY THE RIGHT SALINE FILLED IMPLANT RUPTURED. SHE WAS ALSO EXPERINCING DISCOMFORT FROM THE CAPSULAR CONTRACTURE ON THE IMPLANTS REMOVED. AT THAT TIME SHE ELECTED TO HAVE NEW IMPLANTS TO REPLACE THE ORIGINAL ONES.
PT HAS LOST WEIGHT AND GENERATOR IS LOOSE AND HAS FLIPPED OVER. NEEDS TO BE REPOSITIONED-AND AS GENERATOR IS 1 1/2 YRS OLD-SURGEON DESIRED NEWER MODEL GENERATOR AS REPLACEMENT.
MILD SOB. CAME IN FOR PACEMAKER CHECK, LOST CAPTURE, PACEMAKER REMOVED, LEAD CAPPED, NEW LEAD.
LEFT MAMMARY SILICON FILLED IMPLANT RUPTURED. PT EXPERIENCED PAIN AND NEW ONSET OF FIBROMYLAGIA, WHICH SHE BELIEVED TO BE RELATED TO THE RUPTURED IMPLANTS. SURGERY REQUIRED TO EXPLANT THIS MAMMARY IMPLANT.
RIGHT MAMMARY SILICON FILLED IMPLANT RUPTURED. PT EXPERIENCED PAIN AND NEW ONSET OF FIBROMYALGIA, WHICH BELIEVED TO BE RELATED TO THE RUPTURED IMPLANTS. SURGERY REQUIRED TO EXPLANT THIS MAMMARY IMPLANT.
VALVE WAS SUTURED IN PLACE-LEAKING WAS NOTICED; THEN RE-INFORCED. VALVE CONTINUED TO LEAK, THEN REMOVED AND REPLACED WITH A SECOND VALVE. PHYSICIAN REQUESTS REPORT TO BE FILED. THE VALVE TO BE RETURNED TO THE CO TO DETERMINE THE PROBLEM AND A REPORT RETURNED TO MEDICAL CENTER. DEVICE LEFT IN PLACE 15 MINUTES.
BALLOON (STENT) CROSSED SITE. INFLATED TO 6ATM AND BALLOON RUPTURED. STENT NOT DEPLOYED. UPON EXAMINATION, BALLOON HAD SMALL PIN HOLE CAUSING NON-DEPLOYMENT OF STENT. SECOND STENT OPENED AND DEPLOYED WITH NO PROBLEMS.
FOUR MONTHS PRIOR TO DEVICE REMOVAL, BATTERY STATUS WAS BOLI. ON 1/2/96 WHEN DEVICE WAS CHECKED, BATTERY STATUS WAS ERT2.
ON ALERT/RECALL. LEAD DID FRACTURE WITH WIRE PROTRUDING.
CARDIOPULMONARY ARREST DISCOVERED AND RESUSCITATION STARTED. PT WAS RECEIVING 3 IN 1 TPN VIA CATHETER PLACED IN THE RIGHT SUBCLAVIAN USING 1 PORT. NURSE NOTED TUBING OF FILTER HAD SEPARATED Y-SITE WITH SMALL AMOUNT OF TUBING LEFT ATTACHED TO CATHETER. THERE WAS BLOOD LOSS, BUT THE AMOUNT COULD NOT BE QUANTITATED. PT RESPONDED TO FLUID AND DRUG THERAPY.
CHILD FOUND LYING IN POOL OF BLOOD. UNABLE TO QUANTIFY EXACT AMOUNT. IV TUBING FOUND TO HAVE PROXIMAL IV PORT TO THE PT FOUND WITHOUT RUBBER PIECE, ALLOWING BLOOD TO FLOW FROM PT OUT ONTO BED LINEN. IV ATTACHED TO CATHETER IN CHILD'S 'R' CHEST. CATHETER HAD BEEN ACCESSED FOR LABWORK APPROX 2 HRS EARLIER. WITHIN 24 HRS OF THE EVENT, THE CHILD'S HEMOGLOBIN DROPPED 2.9 GRAMS, NECESSITATING A BLOOD TRANSFUSION.
THE PT WAS IN A BED AND RESTRAINED USING WRIST RESTRAINTS. PT WAS RESTLESS AND KICKING LEGS. TEN MINUTES LATER THE PT WAS FOUND WITH NO PULSE OR RESPIRATIONS. THE PT WAS FOUND ON THE RIGHT SIDE OF THE BED. TH PT WAS OUT OF THE BED, WITH BOTH FEET ON FLOOR, THE LEGS WERE BENT AND THE UPPER BODY BETWEEN BED AND UPPER SIDERAIL. THE SIDE RAILS REMAINED PADDED, IN THE UP POSITION AND THE WRIST RESTRAINTS INTACT. THE BED WAS IN THE LOW POSITION AND WHEELS LOCKED.
DURING CARDIAC CATHETERIZATION PROCEDURE, INTRA-AORTIC BALLOON WAS INSERTED  IN THE PT. THREE DIFFERRENT PRESSURE TRANSDUCERS WERE HOOKED TO THE PRESSURE LINE AND CATHETER. NEITHER OF THE THREE WOULD ZERO. NEW CABLES WERE INSTALLED, AND TRANSDUCERS STILL WOULD NOT ZERO. THE FOURTH TRANSDUCER WAS INSERTED, IT DID ZERO, AND PROCEDURE WAS COMPLETED.
WHILE EXPLANTING DEVICE SURGEON DISCOVERED SILICON PIECE (WELL) DISCONNECTED FROM THE CATHETER.
PT UNDERWENT SURGICAL REMOVAL OF PENILE PROSTHESIS IMPLANT IN 1986 BY ANOTHER SURGEON AT ANOTHER HOSPITAL. ORIGINAL ETIOLOGY UNKNOWN. PROSTHESIS REMOVED. FAILED PENILE PROSTHESIS.
PT ADMITTED FOR ANGIOGRAM; CATHETER USED TO ASSIST IN PLACEMENT OF GUIDEWIRE IN AORTA, UPON REMOVAL OF CATH, RADIOPAQUE TIP CAME OFF AROUND THE AREA OF THE (L) COMMON FEMORAL ARTERY AT THE ARTERIAL PUNCTURE SITE, TIP WAS LOCATED USING 9FRENCH CATH AND REMOVED. PT ADMITTED AS INPATIENT FOR 23 HRS OF OBSERVATION.
DURING A "LAPAPPY" THE APPLIED STAPLER LOCKED DOWN AND WOULD NOT OPEN. THE BROKEN STAPLER LEFT PIECES OF PLASTIC DEBRIS IN PT THE SURGICAL TEAM OPENED THE ABDOMEN AND PROCEEDED TO REMOVE THE APPENDIX.
PT HAD PACEMAKER IMPLANTED 1/16/96. TO OR ON 1/19/96 FOR EROSION OF PACEMAKER POCKET. PT RETURNS TO SURGERY TODAY FOR SAME THING.
COMPLETE EROSION OF PACEMAKER GENERATOR WITH EXPOSED METAL.
THE AMBULANCE WAS CALLED BECAUSE THE PT WAS IN CARDIAC ARREST. WHEN THE AMBULANCE ARRIVED ON THE SCENE, THE EMT INTERMEDIATE AND THE PARAMEDIC STARTED DOING CPR. THEY CONTINUED THE CPR IN THE AMBULANCE AND IN THE ER. THE EMT, A 38-YR-OLD 180 LB MALE, WAS GIVING CHEST COMPRESSIONS. HE FELT A TINGLING SENSATION IN HIS ARMS AND CHEST. HIS FACE TURNED BRIGHT RED AND HE BECAME DIZZY AND WEAK. THE PARAMEDICS, A 45-YR-OLD, 150 POUND FEMALE TOOK OVER CHEST COMPRESSIONS AND RECEIVED A SHOCK. SHE COULD BARELY MAKE IT TO A CHAIR TO SIT DOWN AND COULD NOT GET BACK UP. BOTH THE EMT AND THE PARAMEDIC HAD BAD HEADACHES AND NECK AND BACK PAIN AND BOTH WERE HOSPITALIZED. THE PARAMEDIC ALSO HAD LEG PAIN. THE PT WAS NOT ABLE TO BE RESUSCITATED.
REPEATED PRODUCT PROBLEM WITH THE CLOSED FOLEY SYSTEM. AFTER INSERTION, THE CATHETERS DO NOT DRAIN. STAFF HAVE TRIED IRRIGATION AND, WHEN THAT FAILS, THE CATHETERS ARE REPLACED. THE SYSTEM WAS PURCHASED WITH THE INTENT TO DECREASE INFECTION, BUT THE SYSTEM FAILURES INCREASE THE EXPOSURE BECAUSE OF INCREASED HANDLING AND BREAKING OF SEALS.
S/P RT NON-CEMENTED THR WITH ACETABULAR SHELF RECONSTRUCTION IN 1989 FOR DJD WITH ACETABULAR DYSPLASIA. PT DISLOCATED RT HIP WITHIN 2 WEEKS POST-OP AND WORE ABDUCTION BRACE. DESCRIBES MILD "ACHE" IN RT HIP SINCE SURGERY REQUIRING CANE FOR AMBULATION. THIS PAIN GRADUALLY INCREASED TO POINT PT REQUIRES WC/WALKER FOR AMBULATION. SEEN ON 11/30/95 WITH 2 WEEK HISTORY OF INABILITY TO AMBULATE. X-RAYS SHOW RT HIP DISLOCATION WITH PELVIC DISCONTINUITY. SHEDULED FOR/UNDERWENT REVISION ARTHROPLASTY WHICH REVEALED SUPERIOR ACETABULAR INSERT POLYETHYLENE WEAR ALLOWING CEREMIC-METAL CONTACT. NEW HIP REPLACED. MFR REP NOTIFIED AT THE TIME OF REPLACEMENT.
LAPAROSCOPIC TUBAL LIGATION BEING PERFORMED. TROCAR PIERCED BOWEL. EXPLORATORY LAPORATORY WITH LOOP COLOSTOMY PERFORMED BECAUSE OF PIERCED  BOWEL.
DISRUPTION OF THE TUBING CIRCUIT AT THE POINT OF THE ARTERIAL SENSOR. THE TUBING PACK IS ASSEMBLED BY MFR. THE BANDS WERE IN PLACE BUT CONNECTOR/SENSOR STILL LOOSENED. BOTH ARTERIAL AND VENOUS TUBINGS WERE IMMEDIATELY CLAMPED. AT THIS POINT, THE PT'S BLOOD PRESSURE WAS NO LONGER SUPPORTED BY THE HEART-LUNG MACHINE. NEVERTHELESS, THE PT DID HAVE A HEART BEAT AND DID PRODUCE A BLOOD PRESSURE DURING THE APPROXIMATE 2 MINUTES THAT WAS REQUIRED TO RE-INSTITUTE CARDIOPULMONARY BYPASS. ADDITIONAL 10 ANTIBIOTICS WERE GIVEN. THE PT DID FINE AND WAS DISCHARGED ON THE 4TH POST-OP DAY.
PT IN AUTO ACCIDENT IN 2/95. PT SUSATINED FRACTURED TIBIA, REPAIRED. PT HAS BEEN AMBULATORY FOR PAST 4 MONTHS; HAS DEVELOPED PAIN AND SWELLING. PT WAS FOUND TO HAVE NONUNION OF TIBIA, LEFT X-RAY SHOWS TWO SCREWS BROKEN. ADMITTED FOR SURGERY TO REMOVE SCREWS, INTERLOCKING NAILS AND TO STABILIZE THE TIBIA.
PER MD NOTE PACEMAKER INSERTED IN 1991. PT. SEEN IN OFFICE FOR PACEMAKER FOLLOW-UP. IN THE INTERIM PT HAS BEEN HAVING SOME EPISODES OF DIZZINESS. PACEMAKER WAS CHECKED AND WAS NOTED TO BE AT THE END OF LIFE WITH THE MAGNET RATE BEING DOWN TO 82/MINUTE. PT ADMITTED FOR ELECTIVE PULSE GENERATOR REPLACEMENT 11/30/95.
EPIDURAL PLACEMENT AT L3-4 LEVEL DURING LABOR. PT C/O CALF PAIN AT INITIAL INSERTION. NEEDLE REDIRECTED AND CATHETER THREADED WITHOUT INCIDENT. POST DELIVERY, WITH ATTEMPT AT EPIDURAL CATHETER REMOVAL, APPROX 9.5 CM OF THE CATHETER BROKE. UNABLE TO RETRIEVE REMAINING PORTION VIA SMALL EXCISION AND EXPLORATION WITH HEMOSTAT IN LUMBAR AREA INSERTION SITE. ORTHOPEDIC CONSULT AND LITERATURE REVIEW. MFR CALLED BY ANESTHESIA DEPARTMENT.
CODE TEAM, ON ARRIVAL, FOUND PT WITHOUT PULSE AND GASPING. MONITOR DEFIBRILLATOR WOULD NOT CHARGE ABOVE 50 JOULES OR DISCHARGE. A SECOND DEFIBRILLATOR WAS PROCURRED AND FUNCTIONED NORMALLY. THE EQUIPMENT FAILURE DID NOT AFFECT THE PT OUTCOME.
SUTURE SEPARATED FROM NEEDLE DURING CIS PROCEDURE. MFR'S PRODUCT REP, NOTIFIED.
DURING A LAP CHOLECYSTECTOMY, CLIPS FELL OFF OF THE CLIP APPLIER BEFORE FORMING. ALL CLIPS RETRIEVED. ANOTHER CLIP APPLIER MISFIRED. MFR'S PRODUCT REP NOTIFIED.
ASPEN LABS, 14603 E FREMONT AVE, ENGLEWOOD, CO 80112. THE ELECTROSURGERY ACCESSORY RETURNED TO ASPEN LABS ON THE ABOVE REFERENCED RA WAS LOGGEN AS A COMPLAINT INVESTIGATION WITH THE INDICATED NUMBER. THE INVESTIGATION HAS BEEN COMPLETED AND THE DEVICE WAS DISPOSITIONED AS DESCRIBED BELOW. THIS LETTER IS PROVIDED TO INFORM YOU OF THE FINDINGS, ANY NECESSARY INTERNAL CORRECTIVE ACTION TAKEN TO PREVENT RECURRENCE, AND REQUEST FEEDBACK IF THE INTERNAL CORRECTIVE ACTION WAS NOT ADEQUATE. THE INVESTIGATION REQUEST, ACTION DATES, FINDINGS AND CORRECTIVE ACTION TAKEN IS LISTED BELOW. INVESTIGATION REQUEST: "DURING RIGHT AXILLARY DISSECTION, THE ELECTROSURGICAL PENCIL FAILED TO OPERATE. ANOTHER UNIT WAS PROVIDED TO SURGEON AND FUNCTIONED OK. ESU UNIT OPERATING PROPERLY." REQUEST DATE: 2/2/96, RECEIVED DATE: 2/7/96. ASPEN FINDINGS: "FOUND PENCIL TO BE OPERATING PROPERLY COULD NOT DUPLICATE PROBLEM, ADD'L TRAVEL ON CUT BUTTON BUT DID NOT AFFECT ACTIVATION." CORRECTIVE ACTION: "NONE FURTHER, NO PROBLEM FOUND WITH RETURNED DEVICE. OBSERVE FOR TRENDS." PLEASE FEEL FREE TO CONTACT ME IF YOU HAVE ANY FURTHER QUESTIONS REGARDING THIS COMPLAINT. PLEASE FORWARD THIS LETTER TO OTHER INTERESTED PARTIES WITHIN YOUR ORGANISATION AS NECESSARY.
WHILE USING THE CLIP APPLIER, IT WAS NOTED THAT THE TIP PRONG WAS BENT AND WOULD NOT FIRE.
PHYSICIAN WAS INLATING THE BALLOON ON THE CATHETER. SUDDENLY BLOOD WAS NOTED POURING FROM THE ET INTO THE VENTILATOR TUBING. THE PT BECAME DIFFICULT TO VENTILATE AND AN EMERGENT TRACHEOSTOMY WAS PERFORMED. THE PT ALSO REQUIRED AN EMRGENT BRONCHOSCOPY.
PHYSICIAN INSERTED CATHETER. CATHETER KINKED INSIDE PT'S BLOOD VESSEL AS EVIDENCED BY X-RAY. PHYSICIAN ATTEMPTED TO MANUALLY REMOVE CATHETER.  CATHETER SNAPPED IN TWO PLACES. PT WAS TAKEN TO OPERATING ROOM TO HAVE PIECES SURGICALLY REMOVED.
ABDOMINAL SURGERY 1/10/96. PT RETURNED TO O.R. TODAY WITH FASCIAL DEHISCENCE. SUTURE FOUND TO BE BROKEN OR REMOVED.
RUPTURE OF LOW-BLEED SILICONE GEL BREAST IMPLANT. PT HAS MULTIPLE CHEMICAL SENSITIVITIES AND CHRONIC FATIGUE.
PT HAD LEFT HIP REPLACEMENT IN 6/83. OVER LAST 2-3 YRS. HAS DEVELOPED INCREASED PAIN IN HIP. X-RAYS SHOW EVIDENCE OF A LOOSENING OF THE LEFT HIP WITH SUBSIDENCE. THERE IS FRAGMENTATION OF THE CEMENT. ADMITTED FOR TOTAL HIP REVISION.
CRITICALLY ILL PT UNDERWENT CARDIAC CATHETERIZATION AND I.A.B.P. LEFT SIDE PLACEMENT ON 10/4/95. PT HAD LOSS OF PULSE AND REQUIRED FEMORAL/FEMORAL BYPASS. ON 10/6/95, BLOOD WAS NOTED IN THE LUMEN OF THE I.A.B.P. AND ALARMS SOUNDED. I.A.B.P. WAS DISCONTINUED AND POSITIVE FOR RUPTURE. PT DID NOT REQUIRE A 2ND I.A.B.P. TO BE PLACED.
PT HAD PINS INSERTED AFTER HIP FRACTURE SOMETIME AGO. SINCE THAT TIME PT HAS EXPERIENCED PAIN IN HIP. ON X-RAY FRACTURE APPEARS HEALED BUT HAS SOME DESTRUCTION OF THE ACETABULUM BECAUSE OF PROTRUSION OF AT LEAST 2 OF THE PINS. HAS PAINFUL MOVEMENT OF THE HIP JOINT. ADMITTED FOR REMOVAL OF THE PINS.
NOVACON CORP HAS DETERMINED WITH DR JAMES MTICHELL THAT THIS REPORTED MALFUNCTION DID NOT CAUSE DEATH OR SERIOUS INJURY AND HAS NOT LEAD THE CO TO UNDERTAKE A REMEDIAL ACTION INVOLVING ANY OTHER DEVICE. THEREFORE, NOVACON BELIEVES THIS EVENT IS NOT REPORTABLE IN ACCORDANCE WITH THE MEDICAL DEVICE REPORTING (MDR) REGULATION, 21 CFR, SECTION 803.
THIS 2-YR-OLD MALE WAS ADMITTED TO THE HOSP ON 6/29/95. ON 7/1/95, A #5 FR DOUBLE LUMEN SILASTIC CATHETER WAS PLACED. ON 7/8, IT WAS NOTED THAT IT BROKE BETWEEN THE EXIT SITE AND THE MANIFOLD. ALTHOUGH THERE WAS NO EXPLANATION FOR THE BREAK, IT WAS FELT THAT IT WAS POSSIBLE THAT THE CHILD HAVING ROLLED OVER IN HIS CRIB COULD HAVE CAUSED THE BREAK, ALTHOUGH IT WAS NOTED THAT THE TUBING WAS NOT CAUGHT ANYWHERE. THE CATHETER WAS REPLACED ON 7/8. ON 7/17/95, THE CHILD WAS IN HIS GRANDMOTHER'S ARMS AND THE CATHETER BROKE. THE GRANDMOTHER REPORTED THERE WAS NO EXCESSIVE PULLING ON THE CATHETER. THIS BREAK OCCURRED BETWEEN THE EXIT SITE AND THE MANIFOLD AS WELL. IT SHOULD BE NOTED THAT NURSING TOOK ADD'L STEPS TO SECURE THIS CATHETER ABOVE THE WRITTEN STANDARDS FOR SECURING OF CENTRAL LINES IN AN ATTEMPT TO AVOID A SECOND BREAK. FACILITY HAS EXPERIENCED ANOTHER BREAK IN THE 5.0 FR DOUBLE LUMEN CATHETER. ON 9/8/95, WHILE A NURSE WAS REMOVING AN EIGHT MONTH OLD MALE FROM A STROLLER, THE CVC SNAPPED OFF IN THE SAME SPOT AS THE ONE THAT WAS REPORTED ON 8/1/95. ON 11/27/95 WHILE A PT WAS BEING PICKED UP BY A STUDENT NURSE, THE CATHETER SNAPPED OFF IN THE SAME SPOT AS THE OTHERS AND FELL TO THE FLOOR. PLEASE NOTE THAT THE NURSES ARE SECURING THE CATHETER ABOVE AND BEYOND THE REQUIREMENTS IN AN EFFORT TO AVOID THE BREAKAGE. IN THIS CASE, IT WAS TAPED TO THE PT'S CHEST AND PINNED TO THE GOWN.
PHYSICIAN ATTEMPTED TO REMOVE CAUDAL CATHETER POST PROCEDURE AND MET  SIGNIFICANT RESISTANCE. REPEATED ATTEMPTS BY PHYSICIAN TO REMOVE CATHETER RESULTED IN FRACTURE OF CATHETER WITH A PORTION OF CATHETER RETAINED IN THE CAUDAL CANAL.
UNDERWENT EXPLANTATION OF BILATERAL BREAST IMPLANTS FOR SYMPTOMATIC RELIEF.
UNDERWENT EXPLANTATION OF BILATERAL BREAST PROSTHESES. BOTH IMPLANTS PRESENTED AS RUPTURED UPON EXPLANTATION.
UNDERWENT EXPLANTATION OF BILATERAL BREAST PROSTHESES AND CAPSULECTOMIES. LEFT IMPLANT WAS RUPTURED UPON PRESENTATION.
THIS 3-YR-OLD FEMALE IN-PT AT THE HOSP. A NEW TRACH WAS PLACED ON 6/21/95. ON 6/23/95, THE PT'S MOTHER WAS ATTEMPTING TO SUCTION PT AND THE SUCTIONING CATHETER BECAME CUT AND SEVERED. IT IS BELIEVED THAT THE SUCTION CATHETER WAS AN 8 FR. THERE WAS NO INJURY TO THE PT. THE PT'S MOTHER BROUGHT THE TRACH AND SWIVEL BACK TO THE HOSP ON 7/13/95. UPON INSPECTION, IT WAS NOTED THAT WITHIN THE "ELBOW" OF THE SWIVEL THERE IS A LIP THAT APPEARS TO BE VERY ROUGH AND UPON ATTEMPTING TO PASS THE CATHETER, IT GETS CAUGHT ON THIS LIP.
WHEN GROUNDING PAD REMOVED FROM LEFT LATERAL THIGH A 1 CM BLUISH AREA WAS NOTED WHICH CORRESPONDED TO CRACK IN GROUNDING PAD GEL. NEITHER CRACK IN GEL NOR AREA NOTED PRIOR TO SURGERY. NO BLISTERING NOTED. MFR ALERTED AND PAD RETURNED TO THEM.
IN THE PAST YEAR RPTR HAS EXPERIENCED: EXCESSIVE FATIGUE, UPSET STOMACH; LOSS OF APPETITE, DISTENDED STOMACH, LOOSE STOOLS, ACHING JOINTS, CHRONIC PAIN IN BOTH SHOULDERS AND UPPER ARMS, RIPPLING SENSATION FROM WHAT SEEMS TO BE NERVES OR MUSCLES IN HER ARMS, SIDES OF BACK AND UPPER CHEST.
PT HAD TOTAL HIP REPLACEMENT ON 7/17/95. ON 7/31/95, PT RETURNED DUE TO DISLOCATED TOTAL HIP. PT HAD TO HAVE TOTAL HIP REVISION ON 8/2/95. SURGEON STATED THAT HIP HAD DISLOCATED WHEN PT WAS BEING MOVED FROM WHEELCHAIR AT NURSING HOME. ON 8/14/95 SURGEON STATED THAT THE ACETABULAR LINER HAD TURNED 180 DEGREES WITHIN THE ACETABULAR SHELL.
PT UNDERWENT ROTATIONAL/PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. DURING THE PROCEDURE, THE ROTATIONAL WIRE FRACTURED DISSECTING THE CORONARY ARTERY. PT REQUIRED EMERGENCY CABG TO RETRIEVE THE WIRE AFTER UNSUCCESSFUL ATTEMPT RETRIEVAL.
PT UNDERWENT CATARACT EXTRACTION OF LEFT EYE WITH SMALL INCISION PHACO EMULSIFICATION TECHNIQUE AND IOL INSERTION. PT HAD A SMALL PUPIL AND A HARD NUCLEUS. SURGICAL WOUND CLOSED AND 7-0 STITCH USED. PT SEEN ON 8/29/95, 9/6/95 FOR POST-OP VISITS. ON 9/20/95 MD NOTICED A FOREIGN BODY EMBEDDED IN IRIS AT 8 O'CLOCK. MD HAD NOT PREVIOUSLY NOTICED THIS FOREIGN BODY.
PT HAS HUNTINGTON'S CHOREA. ON 8/21/95, PT WAS EXHIBITING SEVERE CHOREA, THRASHING MOVEMENTS DURING EARLY MORNING HRS. AT 0250 STAFF FOUND PT WEDGED BETWEEN AIR MATTRESS AND SLINGED/PADDED SIDE RAIL, IN PRONE POSITION WITH FACE IN MATTRESS. WAS CYANOTIC AND NOT BREATHING, PULSE WAS PRESENT. MOUTH TO MOUTH RESUSCITATION INITIATED AND PT STARTED BREATHING ON OWN AFTER 2 PUFFS. O2 STARTED. PT SENT TO HOSP ER FOR EVAL. FOUND TO BE STABLE AND RETURNED TO FACILITY. IT SHOULD BE NOTED THAT THE RISKS VS THE BENEFITS OF USING THIS DEVICE WAS CAREFULLY WEIGHED. STAFF AND FAMILY WERE AWARE THAT DEVICE WAS NOT BEING ENTIRELY USED AS INTENDED, AND UP UNTIL THIS INCIDENT, THE BENEFITS OUTWEIGHED THE RISKS. DEVICE REPLACED 8/21/95 WITH STANDARD MATTRESS AND PADDING. BASED ON THE INFO PROVIDED, IT APPEARS THAT THE MATTRESS SYSTEM WAS FUNCTIONING NORMALLY AT THE TIME THE PT SUFFOCATED AND WAS SUBSEQUENTLY RESUSCITATED. ALSO, IT APPEARS FACILITY HAD IDENTIFIED THE RISKS FOR THIS PT WITH THE SYSTEM AND HAD TAKEN MEASURES TO PREVENT SUCH AN OCCURRENCE. IN LIGHT OF THESE FINDINGS, AND DUE TO THE UNUSUAL AND SPECIAL CIRCUMSTANCES REGARDING THE USE OF THE SYSTEM FOR THIS PT, CO DOES NOT SEE THE NEED FOR PRODUCT REDESIGN OR RECALL AND HAS CLOSED THE INVESTIGATION.
A LAPAROSCOPIC RATCHET GRASPER BROKE DURING USE IN THE ABDOMEN ON 1/24/96. SMALL PIECE THE SIZE OF A PINHEAD WAS FOUND TO BE MISSING. 1/24/96 X-RAY: SURGICAL CLIPS IN ABDOMEN AS DESCRIBED. .5MM METALLIC DENSITY STRUCTURE OVERLIES L2 AND COULD REPRESENT A CLIP ON END OR AN ARTIFACT OR AN OBJECT ON THE CLOTHING OR PT DRAPE.
IABP INSERTED DUE TO SEVERE CARDIAC DISEASE. AT 42 HRS POST INSERTION, BLOOD WAS NOTED IN THE TUBING AND ALARMS SOUNDED. POSITIVE IABP RUPTURE. THERE WAS DIFFICULTY IN REMOVING IABP MANUALLY. ATTEMPT AT GROIN EXPLORATION AND REMOVAL UNSUCCESSFUL. REMOVAL VIA RETROPERITONEAL EXPLORATION. IABP WAS LODGED IN THE AORTA.
DURING CATARACT SURGERY, AS THE SURGEON BEGAN TO INJECT THE STERILE OPHTHALMIC VISCOELASTIC INTO THE ANTERIOR CHAMBER OF THE EYE, THE NEEDLE DISLODGED FROM THE SYRINGE AND SHOT ACROSS THE ANTERIOR CHAMBER OF THE EYE CAUSING DISSECTION OF THE IRIS AND CORNEAL TEAR.
DURING VIDEO LAPAROSCOPIC PROCEDURE, SCREW TIP FELL OFF DISSECTOR TIP. X-RAY OF OPERATIVE FIELD NEGATIVE FOR SCREW TIP.
CRITICALLY ILL PT WITH A DIAGNOSIS OF ACUTE M.I./CARDIOGENIC SHOCK REQUIRED IABP ON LEFT SIDE. SIXTY HRS AFTER INSERTION, BLOOD WAS NOTED IN TUBING AND ALARM SOUNDED. POSITIVE RUPTURE IABP. NO COMPLICATIONS, BUT PT REQUIRED A 2ND IABP TO BE PLACED.
AFTER INSERTION OF CATHETER AND INFLATION OF BALLOON WITH 10CC STERILE WATER, BALLOON COULD NOT BE DRAINED OR DEFLATED. SURGEON HAD TO DO A TRANSVAGINAL RUPTURE TO DEFLATE AND DRAIN.
AFTER THE CATHETER INSERTION, THE PT ACUTELY DEVELOPED AN URTICARIAL REACTION ALL OVER HER BODY. HER FACE BECAME RED AND HER BREATHING BECAME SOMEWHAT MORE LABORED. THE PT WAS IMMEDIATELY GIVEN BENADRYL 25 MGS IV AND AFTER ABOUT 45 MINUTES, HER SYMPTOMS RESOLVED. IT WAS IDENTIFIED THAT THE REACTION, HAVING OCCURRED WITHIN MINUTES OF HAVING THE CATHETER PLACED AND HAVING IT FLUSHED, THAT THIS MUST INDEED BE THE CATHETER REACTION THAT HAD BEEN DESCRIBED IN NUMEROUS CASE REPORTS. AS PER OTHER CASE REPORTS, THEY HAD DOCUMENTED IMMEDIATE REMOVAL OF THE CATHETER WOULD RESOLVE THE SYMPTOMS. IT ALSO HAD BEEN NOTED THAT IF BENADRYL WERE GIVEN, CATHETERS COULD BE LEFT IN PLACE. IT WAS FELT THAT RPTR WOULD WATCH THE PT EXPECTANTLY AS SHE WAS GOING TO UNDERGO TREATMENT FOR IV THERAPY AND SEE IF HER SYMPTOMS GOT WORSE OR GOT BETTER. AFTER THE COURSE OF APPROXIMATELY 1 HR, THEY DID RESOLVE AND SUBSEQUENTLY THE PT WAS GIVEN HER DOSE OF ANTIBIOTIC AND SENT HOME. (*)
PT HAD NEWLY DIAGNOSED MALIGNANCY REQUIRING CHEMOTHERAPY, 12/13/95. PORT INSERTED INTO RIGHT SUBCLAVIAN VEIN. ON 12/28/95, INFUSION OF RED BLOOD CELLS APPEARED INFILTRATED DISTAL FROM INSERTION SITE. RADIOLOGY REPORT 12/28/95 CONFIRMED CONTRAST EXTRAVASATION FROM THE CATHETER TRACK IN BOTH DIRECTIONS. 12/30/95, PT RETURN TO OR FOR REMOVAL OF CATHETER.
PT HAVING THERAPEUTIC ABORTION PROCEDURE UNDER LOCAL ANESTHESIA. FLEXIBLE CURETTE TIP BROKE OFF. PHYSICIAN UNABLE TO RETRIEVE BROKEN TIP. PT TAKEN TO SURGERY FOR HYSTERECTOMY.
IV CATHETER INSERTED BY HOME CARE RN FOR VANCOMYCIN INFUSIONS. IMMEDIATELY AFTER INSERTION, PT REPORTED ANXIETY, HIVES, ITCHING, LIP EDEMA. VITAL SIGNS 120/70, PULSE 60, RESPIRATION UNLABORED, T 98. PT TRANSPORTED TO ER AND ARRIVED IN RESPIRATORY DISTRESS. PT GIVEN IV SOLUMEDROL AND PROVENTIL NEBULIZER THERAPY IN ER. PT ADMITTED TO MICU 1/31/96 (CATHETER WAS UTILIZED AS MIDLINE, NOT CENTRAL CATHETER).
THE MESH SCREEN WAS USED FOR A INGUINAL HERNIA REPAIR. THE PT WAS READMITTED WITH SEPSIS AND THE WOUND WAS OPEN AND THE MESH SCREEN REMOVED.  THE WOUND AND SCREEN CULTURED STAPH ORGANISMS.
PT INADVERTENTLY RECEIVED BOTH UVA AND UVB DURING HAND PHOTO THERAPY. UVA WAS ORDERED.
AFTER USE OF THE DEVICE DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE APPEARED SHORTER AND IT WAS DETERMINED THAT APPROX 7CM WAS MISSING. UPON EXPLORATION OF THE ABDOMEN, NOTHING WAS FOUND. THE PROCEDURE WAS COMPLETED. X-RAY WAS   DONE ALTHOUGH THE DEVICE IS NOT RADIOOPAQUE. A SEARCH WAS DONE IN THE OPERATING FIELD/ROOM. A LAPAROTOMY WAS PERFORMED AND THE MISSING PIECE WAS SUCCESSFULLY RETRIEVED FROM A PT.
RPTR IS A 57-YR-OLD WOMAN WHOSE SYMPTOMS DEVELOPED IN 1991 APROXIMATELY EIGHTEEN YEARS AFTER RECEIVING A SET OF GEL-FILLED BREAST IMPLANTS. SYMPTOMS WERE PAIN, FATIGUE, HARDENING OF BOTH BREASTS, WEAKNESS IN HANDS AND SHOULDERS, AND STIFFNESS. IN 1992 THE DOCTOR WHO PUT IN THE IMPLANTS REMOVED THEM BUT LEFT CAPSULES IN THE BREASTS. HER PAIN IS WORSE THAN EVER. IN 1994 A CAPSULECTOMY WAS PERFORMED WHICH WAS VERY UNNECESSARY AS IT SHOULD HAVE BEEN REMOVED IN 1992 DURING THE FIRST SURGERY. SHE NOW HAS FIBROMYALGIA, PAIN IN EARS, STOMACH, ARMS, LEGS, FEET AND FINGERS. SHE IS IN PAIN MOST OF THE TIME.
WHILE PERFORMING A LOW ANTERIOR RESECTION OF THE COLON, THE DEVICE IN QUESTION ONCE FIRED, FAILED TO CUT THE TISSUE. THE DEVICE WAS REMOVED, ANASTOMOSIS REFASHIONED, AND A SECOND, IDENTICAL DEVICE EMPLOYED. AGAIN, DEVICE TORE THE TISSUE RATHER THAN SEVERING IT. PT NEEDED A COLOSTOMY AS A RESULT.
PT HAD A PTCA PROCEDURE ON 7/16/95. THE GUIDEWIRE BECAME LODGED IN VESSEL. HAD TO BE SURGICALLY REMOVED. APPEARS THAT WIRE STRAIGHTENED OUT, RADIOPAQUE SPRING SEPARATED, BUT SAFETY RIBBON REMAINED INTACT.
PT HAVING LAPAROSCOPIC CHOLECYSTECTOMY ON 11/24/95. DURING THE PROCEDURE, THE PRESSURE WAS SET AT 15, BUT ALLEGEDLY THE PRESSURE INCREASED TO 47 WITHOUT ALARM. SURGERY WAS CANCELED. DEVICE TESTED BY HOSP STAFF AND FACTORY, WHO COULD NOT DUPLICATE THE PROBLEM.
AT HEMODIALYSIS WITH THE 1ST MFR'S DIALYZER ON 12/14/95, PT BEGAN FEELING EXTREMELY LIGHTHEADED AND WEAK AT ABOUT 3 MINUTES INTO THE TREATMENT. SHE THEN DEVELOPED A BLANK STARE, APNEA AND SUBSEQUENT CARDIAC ARREST. SHE WAS IMMEDIATELY INTUBATED AND GIVEN SODIUM BICARBONATE AND EPINEPHRINE. SHE REQUIRED MECHANICAL VENTILATION FOR 24 HRS BUT WAS THEN EXTUBATED AND RETURNED TO HER BASE LINE. ON 12/28/95, AT 11 MINUTES INTO HEMODIALYSIS ON THE FIRST MFR'S REPROCESSED DIALYZER USE #1, SHE BECAME EXTREMELY DYSPNEIC, BRONCHOSPASTIC AND DEMONSTRATED AN INTENSE ERYTHEMATOUS FACE AND NECK AND UPPER CHEST CONSISTENT WITH HISTAMINE RELEASE. DIALYSIS WAS IMMEDIATELY DISCONTINUED. ON 1/2/96, THE PT HAD A MILD HYPERSENSITIVITY REACTION AT 13 MINUTES INTO HEMODIALYSIS ON THE 2ND MFR'S DIALYZER. ON 1/3/96 BECAUSE OF VOLUME OVERLOAD PROBLEMS, THE PT WAS ONCE AGAIN DIALYZED ON THE 2ND MFR'S DRY PACK BUT PROPHYLAXED WITH BENADRYL 50 MG AND SOLU MEDROL 40 MG. RPTR HAD ALREADY BEGUN RINSING THE DIALYZER WITH AT LEAST 2 LITERS OF SALINE AGAINST THE DIALYSIS BATH PRETREATMENT. AT THAT TREATMENT, HER O2 SATURATION WAS MONITORED THROUGHOUT THE PROCEDURE WITH A DISCOVERY OF REDUCTION IN O2 SATURATION FROM 93 TO THE LOW 80 RANGE BUT SHE DID NOT DEMONSTRATE ANY HYPERSENSITIVITY REACTION. THUS, THE PT HAD HAD THE REACTIONS ON BOTH POLYSULFONE AND MODIFIED CELLULOSE ACETATE MEMBRANES. SHE WAS DIALYZED ONCE ON A CUPRAMMONIUM RAYON MEMBRANE WITHOUT PROBLEM (12/7/95). AFTER PROPHYLAXIS WITH BENADRYL AND IRRIGATIVE RECIRCULATION OF THE DIALYSIS FILTER WITH 2 LITERS OF SALINE, HEMODIALYSIS WAS INITIATED AT A SLOW BLOOD FLOW RATE ON THE FIRST MFR'S REPROCESSED DIALYZER. AT 8 MINUTES INTO THE TREATMENT, THE PT ONCE AGAIN DEVELOPED SEVERE RESPIRATORY DISTRESS, HYPOTENSION AND APNEA. SHE WAS SEVERELY BRADYCARDIC, APNEIC, CYANOTIC, AND PULSELESS. SHE WAS IMMEDIATELY INTUBATED, GIVEN ATROPINE AND EPINEPHRINE, AND CLOSED CHEST COMPRESSIONS WERE BEGUN. DIALYSIS HAD ALREADY BEEN DISCONTINUED BY THE TIME RPTR ARRIVED. THE PT NEVER REGAINED A PALPABLE PULSE, SUSTAINED CARDIAC RHYTHM, OR REACTIVE PUPILS. THE RESUSCITATIVE EFFORT WAS THUS DISCONTINUED AT 13:24. (*) ALSO SEE 1008287, 1008288. (ALSO SEE 1008287 AND 1008288)
PT WAS UNDERGOING AN ERCP SPHINCTEROTOMY ON 11/29/95. DURING THE PROCEDURE THE SPINCTEROTOME SPARKED AND THE WIRE BROKE DURING COAGULATION. CAUSED PERFORATION IN HOOD OF PAPILLADUODENAL JUNCTION.
AT HEMODIALYSIS WITH THE 1ST MFR'S DIALYZER ON 12/14/95, PT BEGAN FEELING EXTREMELY LIGHTHEADED AND WEAK AT ABOUT 3 MINUTES INTO THE TREATMENT. SHE THEN DEVELOPED A BLANK STARE, APNEA AND SUBSEQUENT CARDIAC ARREST. SHE WAS IMMEDIATELY INTUBATED AND GIVEN SODIUM BICARBONATE AND EPINEPHRINE. SHE REQUIRED MECHANICAL VENTILATION FOR 24 HRS BUT WAS THEN EXTUBATED AND RETURNED TO HER BASE LINE. ON 12/28/95, AT 11 MINUTES INTO HEMODIALYSIS ON THE FIRST MFR'S REPROCESSED DIALYZER USE #1, SHE BECAME EXTREMELY DYSPNEIC, BRONCHOSPASTIC AND DEMONSTRATED AN INTENSE ERYTHEMATOUS FACE AND NECK AND UPPER CHEST CONSISTENT WITH HISTAMINE RELEASE. DIALYSIS WAS IMMEDIATELY DISCONTINUED. ON 1/2/96, THE PT HAD A MILD HYPERSENSITIVITY REACTION AT 13 MINUTES INTO HEMODIALYSIS ON THE 2ND MFR'S DIALYZER. ON 1/3/96 BECAUSE OF VOLUME OVERLOAD PROBLEMS, THE PT WAS ONCE AGAIN DIALYZED ON THE 2ND MFR'S DRY PACK BUT PROPHYLAXED WITH BENADRYL 50 MG AND SOLU MEDROL 40 MG. RPTR HAD ALREADY BEGUN RINSING THE DIALYZER WITH AT LEAST 2 LITERS OF SALINE AGAINST THE DIALYSIS BATH PRETREATMENT. AT THAT TREATMENT, HER O2 SATURATION WAS MONITORED THROUGHOUT THE PROCEDURE WITH A DISCOVERY OF REDUCTION IN O2 SATURATION FROM 93 TO THE LOW 80 RANGE BUT SHE DID NOT DEMONSTRATE ANY HYPERSENSITIVITY REACTION. THUS, THE PT HAD HAD THE REACTIONS ON BOTH POLYSULFONE AND MODIFIED CELLULOSE ACETATE MEMBRANES. SHE WAS DIALYZED ONCE ON A CUPRAMMONIUM RAYON MEMBRANE WITHOUT RPOBLEM (12/7/95). AFTER PROPHYLAXIS WITH BENADRYL AND IRRIGATIVE RECIRCULATION OF THE DIALYSIS FILTER WITH 2 LITERS OF SALINE, HEMODIALYSIS WAS INITIATED AT A SLOW BLOOD FLOW RATE ON THE FIRST MFR'S REPROCESSED DIALYZER. AT 8 MINUTES INTO THE TREATMENT, THE PT ONCE AGAIN DEVELOPED SEVERE RESPIRATORY DISTRESS, HYPOTENSION AND APNEA. SHE WAS SEVERELY BRADYCARDIC, APNEIC, CYANOTIC, AND PULSELESS. SHE WAS IMMEDIATELY INTUBATED, GIVEN ATROPINE AND EPINEPHRINE, AND CLOSED CHEST COMPRESSIONS WERE BEGUN. DIALYSIS HAD ALREADY BEEN DISCONTINUED BY THE TIME RPTR ARRIVED. THE PT NEVER REGAINED A PALPABLE PULSE, SUSTAINED CARDIAC RHYTHM, OR REACTIVE PUPILS. THE RESUSCITATIVE EFFORT WAS THUS DISCONTINUED AT 13:24. (*) ALSO SEE 1008287, 1008288. (ALSO SEE 1008286 AND 1008288)
AT HEMODIALYSIS WITH THE 1ST MFR'S DIALYZER ON 12/14/95, PT BEGAN FEELING EXTREMELY LIGHTHEADED AND WEAK AT ABOUT 3 MINUTES INTO THE TREATMENT. SHE THEN DEVELOPED A BLANK STARE, APNEA AND SUBSEQUENT CARDIAC ARREST. SHE WAS IMMEDIATELY INTUBATED AND GIVEN SODIUM BICARBONATE AND EPINEPHRINE. SHE REQUIRED MECHANICAL VENTILATION FOR 24 HRS BUT WAS THEN EXTUBATED AND RETURNED TO HER BASE LINE. ON 12/28/95, AT 11 MINUTES INTO HEMODIALYSIS ON THE FIRST MFR'S REPROCESSED DIALYZER USE #1, SHE BECAME EXTREMELY DYSPNEIC, BRONCHOSPASTIC AND DEMONSTRATED AN INTENSE ERYTHEMATOUS FACE AND NECK AND UPPER CHEST CONSISTENT WITH HISTAMINE RELEASE. DIALYSIS WAS IMMEDIATELY DISCONTINUED. ON 1/2/96, THE PT HAD A MILD HYPERSENSITIVITY REACTION AT 13 MINUTES INTO HEMODIALYSIS ON THE 2ND MFR'S DIALYZER. ON 1/3/96 BECAUSE OF VOLUME OVERLOAD PROBLEMS, THE PT WAS ONCE AGAIN DIALYZED ON THE 2ND MFR'S DRY PACK BUT PROPHYLAXED WITH BENADRYL 50 MG AND SOLU MEDROL 40 MG. RPTR HAD ALREADY BEGUN RINSING THE DIALYZER WITH AT LEAST 2 LITERS OF SALINE AGAINST THE DIALYSIS BATH PRETREATMENT. AT THAT TREATMENT, HER O2 SATURATION WAS MONITORED THROUGHOUT THE PROCEDURE WITH A DISCOVERY OF REDUCTION IN O2 SATURATION FROM 93 TO THE LOW 80 RANGE BUT SHE DID NOT DEMONSTRATE ANY HYPERSENSITIVITY REACTION. THUS, THE PT HAD HAD THE REACTIONS ON BOTH POLYSULFONE AND MODIFIED CELLULOSE ACETATE MEMBRANES. SHE WAS DIALYZED ONCE ON A CUPRAMMONIUM RAYON MEMBRANE WITHOUT RPOBLEM (12/7/95). AFTER PROPHYLAXIS WITH BENADRYL AND IRRIGATIVE RECIRCULATION OF THE DIALYSIS FILTER WITH 2 LITERS OF SALINE, HEMODIALYSIS WAS INITIATED AT A SLOW BLOOD FLOW RATE ON THE FIRST MFR'S REPROCESSED DIALYZER. AT 8 MINUTES INTO THE TREATMENT, THE PT ONCE AGAIN DEVELOPED SEVERE RESPIRATORY DISTRESS, HYPOTENSION AND APNEA. SHE WAS SEVERELY BRADYCARDIC, APNEIC, CYANOTIC, AND PULSELESS. SHE WAS IMMEDIATELY INTUBATED, GIVEN ATROPINE AND EPINEPHRINE, AND CLOSED CHEST COMPRESSIONS WERE BEGUN. DIALYSIS HAD ALREADY BEEN DISCONTINUED BY THE TIME RPTR ARRIVED. THE PT NEVER REGAINED A PALPABLE PULSE, SUSTAINED CARDIAC RHYTHM, OR REACTIVE PUPILS. THE RESUSCITATIVE EFFORT WAS THUS DISCONTINUED AT 13:24. (*) ALSO SEE 1008287, 1008288. (ALSO SEE 1008286 AND 1008287)
A PHYSICIAN WAS USING THE BASKET TO RETRIEVE A STONE FROM THE PT'S RIGHT URETER AND THE BASKET FELL APART. SEVERAL WIRES APPEARED TO BE BROKEN. ALL PARTS WERE RETRIEVED AND THERE WAS NO HARM DONE TO THE PT.
WHEN THE GENERATOR WAS TURNED ON, A LOUD ALARM WOULD SOUND AND THE USERS WERE UNABLE TO GET THE TEMPERATURE TIP TO REGISTER. AS A RESULT, THE PHYSICIAN WAS UNABLE TO PERFORM A PERCUTANEOUS RHIZOTOMY DUE TO THE ALARM AND UNREGISTERING TEMPERATURE.
PT PRESENTED TO FACILITY FOR FAILED RIGHT TOTAL HIP REPLACEMENT, REVISION OF THE RIGHT HIP REPLACEMENT BY REMOVAL OF COMPONENTS AND REPLACEMENT WITH A CEMENTED LONG-STEMMED FEMUR AND UNCEMENTED ACETABULUM. RIGHT HIP REPLACEMENT DONE ON 2/6/89 AT ANOTHER FACILITY.
RPTR HAD 1/86: BREAST AUGMENTATION WITH SILICONE GEL IMPLANTS. 1987-1994 SHE HAD CAPSULITIS OF LEFT BREAST AND CHRONIC PAIN. 1988 - PRESENT SHE C/O CHRONIC BURNING PAIN IN NECK/SHOULDER, ESPECIALLY RIGHT UPPER EXTREMITY. SHE ALSO HAS "URGENT" BLADDER. 1992 - PRESENT SHE C/O INSOMNIA, CHRONIC FATIGUE AND NUMBING AND TINGLING IN EXTREMITIES. 11/94 SHE HAD EXPLANTATION OF IMPLANTS RESULTING IN SEVERE SCARRING AND DISFIGUREMENT. 1995 - PRESENT SHE C/O PAIN IN LEFT HIP AND VERY COLD HANDS AND FEET (ESP NIGHT).
CODE WAS CALLED AND DEFIBRILLATOR DID NOT "FIRE." ANOTHER DEFIBRILLATOR WAS OBTAINED AND THE PT DID NOT EXPERIENCE ANY PERMANENT DAMAGE AS A RESULT. THE FAULTY DEFIBRILLATION HAD BEEN TESTED PRIOR TO THE INCIDENT AND AFTER THE INCIDENT AND THERE WAS NO PROBLEM WITH THE WAY IT FUNCTIONED.
DURING USE, RECIPROCATING SAW LEAKED BLACK FLUID INTO PT'S ORAL CAVITY. INSTRUMENT WAS REMOVED FROM FIELD AND SENT TO BIOMEDICAL ENGINEERING FOR EVALUATION. PT'S ORAL CAVITY WAS IRRIGATED WITH 1000 CC OF SALINE. PROCEDURE WAS COMPLETED. PT WAS IN STABLE CONDITION. AT POST-OP, NO INFECTION; NO SEQUELAE FROM INCIDENT.
PT HAD LASER LITHOTRIPSY 1/17/95. INFO GATHERED ON 1/31/95 REVEALED THAT THE PT HAD PASSED THE STONE AS WELL AS SOME DEBRIS THAT APPEARED TO BE GOLD METAL PARTICLES AND SMALL DIAMETER ROD SHAPED PIECE OF METAL. THE PT HAD INFORMED THE DR THAT PERFORMED THE PROCEDURE OF THIS. THE PT ALSO STATED THAT HE WOULD MAINTAIN POSSESSION OF THE PARTICLES AND ROD SHAPED PIECE IN CASE SOME FUTURE PROBLEM IS ENCOUNTERED. AT THE TIME OF THIS REPORT, THE HOSP HAS NO KNOWLEDGE OF ANY ADVERSE OUTCOME RESULTING FROM THIS INCIDENT.
WHILE PERFORMING CYSTOSCOPIC-LASER STONE DISINTEGRATION, THE DR WAS LASING A STONE HELD IN THE BASKET. THE BASKET BROKE AND RUPTURED THE URETER. THIS RESULTED IN HAVING TO DO AN OPEN URETROLITHOTOMY TO REMOVE THE STONE AS WELL AS THE BASKET. BASKET AND ETC AVAILABLE FOR EVALUATION.
LENSES HAVE BEEN DISTRIBUTED THAT ABSORB LIGHT IN A PORTION OF THE VISIBLE RANGE (APPROX 460 - 500 NM) AND CONSEQUENTLY DO NOT CONFORM TO THE SPECTRAL TRANSMITTANCE CURVE PROVIDED IN THE PRODUCT LABELING. THIS INFO WAS INITIALLY RECEIVED BY CO FROM A PHYSICIAN AND PROMPTLY CONFIRMED BY IN-HOUSE TESTING. THIS INFO WAS OBTAINED DURING THE COURSE OF AN ONGOING INVESTIGATION OF A NUMBER OF RECENT REPORTS OF LENSES WITH A YELLOW APPEARANCE. AS OF 1/26/96, 197 LENSES HAVE BEEN REPORTED TO EXHIBIT THIS PHENOMENON; 136 OF THESE LENSES HAVE BEEN RETURNED TO CO THUS FAR. NINE (9) LENSES WITH A YELLOW APPEARANCE HAVE REPORTEDLY BEEN IMPLANTED TO DATE. THESE 197 REPORTS REPRESENT LESS THAN 0.03% OF THE TOTAL LENSES DISTRIBUTED TO DATE. CO IS ACTIVELY INVESTIGATING THESE REPORTS. CORRECTIVE ACTIONS IMPLEMENTED AT THIS TIME: STERILIZATION OF PRODUCT AT STERILIZING CO HAS BEEN SUSPENDED AS OF 1/25/96, PENDING THE RESOLUTION OF THIS INVESTIGATION. DISTRIBUTION OF LENSES MFG AT THE MFG FACILITY BETWEEN AUGUST AND OCTOBER, 1995 HAS BEEN SUSPENDED AS OF 1/26/96, PENDING THE RESOLUTION OF THIS INVESTIGATION. CO IS PREPARING A "DEAR CUSTOMER" LETTER TO INFORM PHYSICIANS ABOUT THIS PHENOMENON AND TO REQUEST THAT THEY RETURN ANY LENS EXHIBITING A YELLOW APPEARANCE TO CO FOR REPLACEMENT. CO WILL PROVIDE A CONCURRENT COPY OF THIS COMMUNICATION TO FDA. CO WILL ESTABLISH AND MAINTAIN A LOG OF PTS IMPLANTED WITH LENSES EXHIBITING THIS YELLOW APPEARANCE TO MONITOR FOR ANY LATENT CLINICAL EFFECTS. (*)
RPTR HAD AN MRI SCAN OF HIS NECK AND LOWER BACK. HE COMPLAINED THAT THE MRI WAS NOISY AND IT WAS HURTING HIS EARS. THE FIRST TIME HE WAS GIVEN MUSIC, HE COMPLAINED HE COULD NOT HEAR THE MUSIC. THE TECHNICIAN PUT HIM IN THE MACHINE AGAIN WITH EAR PLUGS. HIS EARS STILL HURT. THE TECHNICIAN KEPT PUTTING HIM BACK IN THE MRI SCANNER. HE ASKED HOW LOUD THE MACHINE WAS. THE TECHNICIAN SAID ROCK CONCERT LEVEL. RPTR TOLD HIM THE EAR PLUGS DID NOT HELP. HE INSISTED IN FINISHING THE SCAN. RPTR HAD THE SCAN ON 8/20/95 AROUND 5:00 PM AND HE HAS HAD 3 MEDICAL TESTS AND ALL SAID HE HAD TRAUMA TO HIS EARS AND TINNITUS. HE HAS HEARING TESTS EVERY SIX MONTHS. HE STILL HAS TINNITUS. HE IS A 49-YR-OLD MALE WITH NO HISTORY OF TINNITUS. THIS IS THE FIRST TIME IN HIS LIFE. HE NOW IS A MEMBER OF THE AMERICAN TINNITUS ASSOCIATION. THE HOSP PROMISED TO CONTACT THE MFR. THEY WILL NOT COMMENT TO RPTR. THE HOSP IS FULLY AWARE OF WHAT HAPPENED. THEY PROMISED TO CONTACT THE MFR AND TO GET BACK WITH RPTR. THEIR RISK MANAGER STILL HAS NOT GOTTEN BACK WITH RPTR AS TO WHAT THE MFR IS SAYING. HE DID SAY THE MACHINE WAS TESTED AND IT WAS IN WORKING ORDER. RPTR WANTED TO KNOW IF OTHER PTS HAVE HAD THE SAME PROBLEM. (*)
THE COMPLAINANT IS COMPLAINING THAT HER FATHER FELL AND INJURED HIS RIGHT ELBOW AFTER THE MECHANICAL WALKER THAT HE WAS USING COLLAPSED. THE INJURY INCIDENT HAPPENED ON 10/23/95. THE COLLAPSE OF THE MECHANICAL WALKER OCCURRED AT THE RIGHTSIDE OF THE WALKER, ABOVE THE WHEEL ON THE FRAME. BECAUSE OF THE ELBOW INJURY HER FATHER SUSTAINED FROM THE FALL, HER FATHER RECEIVED NUMEROUS VISITS WITH THE DOCTOR. HER FATHER HAS BEEN USING THE WALKER SINCE 12/93. DEFECT WARRANTY HAD EXPIRED IN 1994. BUT, THE FRAMEWORK FOR THE WALKER HAS A LIFETIME WARRANTY. THE MECHANICAL WALKER WAS EVENTUALLY RETURNED TO THE MFR THROUGH THE RETAIL STORE SUBSEQUENTLY AFTER 10/24/95. THE WALKER WAS PURCHASED THROUGH MEDICARE. THE COMPLAINANT'S FATHER FINALLY RECEIVED A NEW WALKER TO REPLACE THE DEFECTED ONE ON 11/3/95.
RPTR IS MAKING COMPLAINT FOR A CLIENT. THE CLIENT WAS IN HIS WHEELCHAIR WAITING IN LINE. THE CHAIR STARTED UP ON ITS OWN, WENT INTO REVERSE FOR A DISTANCE, THEN FORWARD AND HIT A COUNTER AND THE CLIENT WAS THROWN FROM THE CHAIR, SHATTERING HIS RIGHT FEMUR.
IN 1/86 COMPLAINANT HAD A REPEAT CESAREAN SECTION DONE, AND HAD MONO FILAMENT SUTURES (WIRE SUTURES 2.0) USED TO CLOSE HER INCISION AND HOLD A NETTING FOR HERNIA IN PLACE. IN 5/95 SHE BEGAN TO HAVE SEVERE ABDOMINAL PAINS. SHE WENT TO HER GYNECOLOGIST WHO DID SEVERAL TESTS BUT COULD NOT FIND THE CAUSE, SO SHE SENT HER TO A SURGEON WHO DID FURTHER TESTS AND DISCOVERED THAT THE STITCHES HAD BROKEN INSIDE OF HER ABDOMEN AND WRAPPED ROUND THE WIRE MESH AND CAUSED ALL OF THE PROBLEMS. HE DID AN OPERATION AND REMOVED THE WIRE MESH AND SUTURES. 6 WEEKS LATER SHE BEGAN TO HAVE MORE PAINS, AND WENT BACK TO THE DR. HE HAD MORE TESTS DONE AND DID AN EXPLORATORY SURGERY, FOUND "LARGE SEROMA CAVITY" IN HER ABDOMEN WHICH TO THIS DAY DOES NOT HEAL. SHE HAD OTHER OPERATIONS AFTER THIS LAST ONE AND NOW SHE IS SCHEDULED TO SEE A PLASTIC SURGEON TO TRY AND SEE IF THEY CAN GET THE OPEN WOUND TO HEAL.
COMPLAINANT BELIEVES THAT THE COMPANY IS IMPORTING A REPRODUCTIVE DEVICE IN VIOLATION OF FDA REGULATIONS (LABELING PROBLEMS). HE SAID THE FDA INFORMED THE COMPANY AT THE AMERICAN FERTILITY SOCIETY MEETING ON 10/7/95 THAT THEIR DEVICES COULD NOT BE IMPORTED. (*)
IN ORDER TO DETERMINE IF STREP TEST IS NEGATIVE OR POSITIVE, YOU HAVE TO TAKE TOO MUCH TIME TO READ IT. POSITIVE RESULTS ARE NOT CLARIFIED IN COLOR. YOU CAN BARELY SEE THE FAINT COLOR TRIANGLE. IT IS HARD TO DISTINGUISH A POSITIVE STREP. STREP TEST NOT DESIGNED PROPERLY. A POSITIVE TEST IS TRIANGLE BUT THE COMPANY'S EXPLANATION STATES A FAINT COLOR CHANGE (PINK) WITH A NEGATIVE BAR SIGN IS POSITIVE.
WOULD NOT WORK TWICE THEN CROSSED CLIP ON ITSELF.
DURING TAH, SUTURE MATERIAL SEPARATED FROM NEEDLE. MFR'S PRODUCT REP NOTIFIED.
DURING A THORACOTOMY PROCEDURE, STAPLER FAILED TO CORRECTLY FORM THE STAPLES. MFR'S PRODUCT REP NOTIFIED.
WHILE USING THE CLIP APPLIER, IT MALFUNCTIONED AND WOULD NOT RELOAD A CLIP. CARTRIDGE WAS THE ORIGINAL THAT CAME WITH APPLIER.
DURING ROUTINE OR PROCEDURE TABLE FAILED TO RISE. HAD TO BRING ANOTHER OR TABLE INTO ROOM, DELAYING PROCEDURE ABOUT 45 MINUTES.
PRODUCT BEGAN LEAKING FROM MOLDING POINT APPROXIMATELY 2" BELOW SPIKE TIP DURING AN OR PROCEDURE. THE STERILE IV FLUID WAS CONTAMINATED.
CHILD VENTILATED BY A ET TUBE FOR LARYNGEAL PAPILLOMA SURGERY. WHILE WEANING OFF VENTILATOR DURING SURGERY 02 DESATURATED AND PT BEGAN RETRACTING. CHEST X-RAY SHOWED BILATERAL PNEUMOTHORACES. REQUIRED CHEST TUBES, ANTIBIOTICS AND AN ICU STAY.
SKIN UNDER PROXIMAL ELECTRODE OF PERIPHERAL LEFT NERVE STIMULATOR LEFT VOLAR SURFACE UPPER EXTREMITY AT THE WRIST HAD MINOR INJURY SECONDARY TO THE DEVICE. SEVERAL SMALL PETECHIAE NOTED. HE HAD UNDERGONE ULNAR NERVE STIMULATION INTERMITTENTLY FOR 4 DAYS MONITORING DEGREE OF NEUROMUSCULAR BLOCKADE BY STUDY DRUG.
RN DREW 1 CC OF BLOOD FOR BLOOD CULTURE. CHANGED NEEDLES TO ENSURE STERILE ENTRY INTO CULTURE TUBE. EXPELLED .5 CC OF BLOOD INTO CULTURE VIAL, THEN PRESSURE FROM TUBE CAUSED NEEDLE TO DETACH FROM SYRINGE CAUSING BLOOD TO SPLATTER OVER RN, COUNTERTOPS AND PT.
SPINAL CORD STIMULATOR ELECTRODE DISLODGEMENT/MALFUNCTION. QUAD LEAD PLACED AT APPROXIMATELY T9-10 AND AN IMPULSE GENERATOR MALFUNCTIONED OVER PAST TWO WEEKS 1/1 - 1/16/96. SURGERY REQUIRED TO REPLACE LEAD. INITIAL LEAD PLACEMENT UNKNOWN AS TO TIME/DATE LOCATION.
SPINAL CORD STIMULATOR ELECTRODE DISLODGEMENT/MALFUNCTION. LEAD PLACED AT APPROXIMATELY T9-10 AND AN IMPULSE GENERATOR MALFUNCTIONED OVER PAST TWO WEEKS 1/1 - 1/16/96. SURGERY REQUIRED TO REPLACE LEAD. INITIAL LEAD PLACEMENT UNKNOWN AS TO TIME/DATE LOCATION.
DURING THE OPERATIVE PROCEDURE THE SURGEON AND ASSISTANT NOTED WHAT LOOKED LIKE "METAL FLECKS" IN THE VAGINAL AREA. UPON CLEANING, THE OR NURSE SAW THE TIP OF THE INNER RESECTOSCOPE SHEATH WITH A JAGGED EDGE.
WHILE VENTILATOR WAS CONNECTED TO INTUBATED PT, VENTILATOR FAILED TO CYCLE WITH A COMPLETE SHUTDOWN (BLANK INSTRUMENT FACE AND "VENT INOP" DISPLAY). NO FLUCTUATION OF LINE PRESSURE OR POWER FAILURE PRESENT. MACHINE IMMEDIATELY TAKEN OFF PT WITH BAG - ETT VENTILATION INITIATED. IMMEDIATELY REPORTED TO REPRESENTATIVE/DISTRIBUTOR. THIS WAS A WITNESSED EVENT.
DURING ANGIOPLASTY OF RCA, 0.018 CM ANGIOPLASTY WIRE WAS BEING REMOVED FROM ARTERY BY PHYSICIAN WHEN IT CAME APART (FRAYED), LEAVING APPROXIMATELY 3 CM OF TIP STILL IN MID-RCA. UNABLE TO REMOVE FRAGMENT FROM PT. PT CONDITION: STABLE.
TUBING WAS PRIMED WITH GAMIMUNE. WHEN PLACED IN PUMP A LEAK WAS NOTICED IN THE TUBING AT THE 1ST PORT NEAREST TO SPIKE.
EPIDURAL PUMP INDICATED THAT PUMP WAS WORKING AND NO ALARMS WERE SOUNDING BUT NOTHING WAS PUMPING THROUGH TUBING. PROBLEM APPEARS TO HAVE BEEN THAT TUBING HAD BEEN CRIMPED BY RESERVOIR CLAMP AND DID NOT RETURN TO OPEN POSITION DUE TO THE FACT THAT RESERVOIR HAD BEEN REFRIGERATED AND WAS COLD. PUMP DID NOT RECOGNIZE THIS. PUMP WORKED PROPERLY AFTER TUBING SOFTENED.
BLUE END CAP CANNOT BE REMOVED FROM EXTENSION SET. RPTR HAS HAD A NUMBER OF COMPLAINTS IN THE PAST.
THORACENTESIS PERFORMED ON LEFT UPPER CHEST/LUNG ON 1/29/96 AT 11:05 AM. DOCTOR REMOVED CATHETER POST PROCEDURE AND NOTED THAT THE CATHETER WAS SHORTER AND POSSIBLY REMAINED IN THE PT. CHEST X-RAY CONFIRMED CATHETER PIECE REMAINED IN THE PT.
BILATERAL SILICONE BREAST IMPLANTS WERE FOUND TO BE RUPTURED UPON EXPLANTATION.
PT ON PCA MSO4 PUMP FOR CHRONIC CANCER PAIN. HE RECEIVES A CONTINUOUS DOSE HOURLY AND HAS THE OPTION OF A BOLUS DOSE EVERY 6 MINUTES. PT HAD BEEN ON THIS PUMP SINCE 9/19/96. ON EVENT DATES ABOVE, PT PRESSED BOLUS DOSE BUTTON ON PUMP AND THE PUMP WENT INTO THE STOP MODE EACH TIME. PT COULD NOT GET BOLUS DOSE UNTIL HE REMOVED BATTERY FROM PUMP AND RESTARTED IT; THEREFORE, PT WAS WITHOUT BOLUS DOSE FOR EXTENDED PERIOD. PUMP SENT TO MFR.
RPTR HAD A TOTAL OF 2 BREAST SURGERIES BEGINNING WITH FIRST IMPLANT SURGERY. A MEDICAL PROFESSIONAL HAS CONFIRMED SILICONE IN THE SURROUNDING BREAST TISSUE. SHE HAD INFECTION, EXCESS FLUID AND NUMBNESS IN THE SURGICAL AREA AND BLEEDING THROUGH THE ENVELOPE. SHE C/O: BLOOD PRESSURE PROBLEMS, PERIPHERAL NEUROPATHY, OTHER NEUROPATHY, CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, CHEST/RIB CAGE PAIN AND/OR BURNING SENSATION, ELEVATED CHOLESTEROL OR TRIGLICERIDES, RAPID EYE DETERIORATION, THYROID PROBLEMS, CHRONIC SWELLING AND PAIN IN EXTREMITIES, FREQUENT LOW GRADE FEVER, IRRITABLE BOWEL SYNDROME, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATION, FREQUENT MIGRAINES/SEVERE HEADACHES, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, SJOGREN'S SYNDROME, INFLAMMATION, SWELLING, PAIN/ARTHRALGIA AND RHEUMATOID ARTHRITIS, PERSISTENT STIFFNESS OF JOINTS, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY UNDER ARMS AND NECK, CHRONIC UNEXPLAINED MUSCLE SPASMS, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING OF SKIN, NUMEROUS MOLES, FRECKLES, ETC, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, CLUMSINESS/DROPS THINGS. (*)
AT 2120 ON 11/8/95, ONE WAY STOPCOCK IN TUBING USED TO ADMINISTER TOTAL PARENTERAL NUTRUTION INTO ECMO CIRCUIT CRACKED RESULTING IN ACUTE BLOOD LOSS OF APPROX 160CC'S. PT REQUIRED VOLUME RESUSCITATION. CONDITION STABLIZED WITHIN APPROX FIVE MINS.
PT WITH SINUS VENOSUS ATRIAL SEPTAL DEFECT. TO OPERATING ROOM 8/29/95 FOR PERICARDIAL BAFFLE AND CLOSURE OF ASD. ECHO DONE ON 8/31/95 SHOWED PATCH DEHISCENCE WITH RESIDUAL ASD. RETURNED TO OR 9/4/95 FOR REDO OF PRIMUM ASD REPAIR.
PT HAD CLOSURE OF CLEFT MITRAL VALVE AND PRIMUM ATRIAL SEPTAL DEFECT (ASD) ON 8/1/95. ON REGULAR FOLLOW-UP VISIT, PT NOTED TO HAVE MURMUR AND ECHO REVEALED ATRIAL SHUNT AND ATRIAL PATCH CURLED UPON ITSELF. PT RETURNED TO OR ON 9/1/95 FOR REDO OF PRIMUM ASD REPAIR.
PT HAD ELECTIVE CARDIAC SURGERY ON 8/23/95 OF CLOSURE OF CLEFT MITRAL VALVE AND CLOSURE OF PRIMUM ATRIAL SEPTAL DEFECT (ASD). ECHO DONE ON 8/29/95 SHOWED LEAK IN THE ASD CLOSURE. PT RETURNED TO OR ON 8/30/95 FOR REDO OF PRIMUM ASD REPAIR.
PLATE USED IN REPAIR OF SYMPHYSIS PUBIS FRACTURE BROKE 20 DAYS AFTER INSERTION. PT UNDERWENT 2ND SURGERY TO REMOVE BROKEN PLATE AND SCREWS AND THEN REPLATE.
UPON PHYSICIAN INJECTING MEDICATION INTO THE ANTERIOR CHAMBER, WHITE PARTICULATE MATTER WAS NOTED. IT WAS NOT VISIBLE TO THE NAKED EYE ONLY VISIBLE UNDER MICROSCOPE. THE PARTICULATE MATTER CONTINUED WITH INJECTION INDICATING IT WAS NOT IN THE NEEDLE. ANOTHER VIAL WAS USED WITHOUT INCIDENT.
A 43-YR-OLD WOMAN CURRENTLY SUFFERING FROM COMPLICATIONS OF HER PREVIOUS BREAST IMPLANTS. THE PT HAD BILATERAL BREAST AUGMENTATION IN 6/95 USING SALINE-FILLED IMPLANTS. BECAUSE OF SIGNIFICANT PAIN AND DISCOMFORT IN THE AXILLA AND IN THE BREAST, BOTH IMPLANTS WERE REMOVED DURING AN ABDOMINAL SURGERY IN 12/91. FOLLOWING REMOVAL THE PT CONTINUED TO HAVE CHEST WALL PAIN WITH PULLING AND STINGING SENSATION IN THE LEFT NIPPLE. LEFT UPPER ARM MOTION WOULD AGGRAVATE PAIN IN THE BREAST AND CHEST AREA. THE PT ALSO CONTINUED TO HAVE A SKIN RASH ON THE CHEST AND AXILLA. A BIOPSY IN 10/93 SHOWED THIS RASH TO BE IMMUNOLOGICALLY MEDIATED WITH DERMAL PERIVASCULAR LYMPHOCYTIC INFILTRATION. A BREAST BIOPSY IN 8/94 ALSO SHOWED DENSE FIBROSIS AND FOCAL CHRONIC INFLAMMATION.
CONTINUOUS EPIDURAL STARTED WITH 10 CC/HR. VOLUME LIMIT ON PUMP WOULD NOT GO ABOVE 10 CC. RATE AND PUMP WERE SET CORRECTLY. ALARM ON PUMP RANG. WHEN STAFF WENT TO SHUT OFF ALARM THEY NOTICED 35 CC OF SOLUTION HAD ALREADY INFUSED. THE PUMP WAS TAKEN OFF AND DR NOTIFIED. PT HAD NUMBNESS IN HER ARMS AND HANDS BUT ABLE TO MOVE THEM WELL. DERMATOME LEVEL C4 - C5.
FIVE UNITS WOULD NOT FLOW. THE SAMPLES WERE PROVIDED FOR CO ANALYSIS. ALL 5 SAMPLES WERE TESTED FOR FLOW VIA PRESSURE FROM A SYRINGE. THE FLOW DIFFICULTY WAS CONFIRMED. THE CLEAR BACKPLATE OF THE MODULES WAS REMOVED TO PROVIDE THE CLOSER ANALYSIS OF THE TUBING ASSEMBLIES. THE INVESTIGATION REVEALED THE TUBING HAD BECOME CROSSLINKED, OCCLUDING THE FLOW PATH. EACH OF THE TUBING ASSEMBLIES HAD TO BE MANIPULATED TO ACHIEVE FLOW. A CAUSE OF THE FLOW DIFFICULTY COULD NOT BE DETERMINED. HOWEVER, MODIFICATIONS TO THE PRODUCTION PROCESS HAVE SIGNIFICANTLY REDUCED THE FREQUENCY OF THIS OCCURRENCE. CO WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.
CRITICAL CARE PT UNDERGOING CONTINUOUS MONITORING. ICP WAVE FORMS ON MONITOR NOTED TO BE FLAT. MONITORS CHECKED. BP READING NOTED ON SCREEN ONLY.
AT CONCLUSION OF CARDIAC SURGERY PR0CEDURE, SURGEON ATTEMPTED DEFIBRILLATION VIA SYNC CONTROL FROM PT MONITOR. ON FIRST ATTEMPT, SYNC PULSE FAILED; SECOND ATTEMPT SUCCESSFUL.
WRONG HIP BALL PROSTHESIS IMPLANTED. FELT TO BE DUE TO IDENTICAL PACKAGING OF THE TWO TYPES OF HIP BALLS.
TESTER SLIPPED OFF AND SURGEON WAS UNABLE TO RETRIEVE FROM PT. TESTER COULD NOT BE LOCATED IN PT ON X-RAY BECAUSE IT IS NOT RADIOPAQUE.
THERE WERE TWO CASES WHERE THE CATHETER FRACTURED WHILE IN THE PT. BOTH PTS REQUIRED INVASIVE PROCEDURES TO RETRIEVE THE DISTAL FRAGMENT.
WHILE THE PT WAS UNDERGOING AN ELC, A FIRST DEGREE BURN AT THE EPIGASTRIC TROCAR SITE OCCURRED WHILE USING THE BOVIE. SPARKS WERE NOTED AT THE TROCAR JUNCTION OF THE METAL HEAD AND PLASTIC SLEEVE.
ON FRIDAY DEC 15TH THE THERAPIST WAS WORKING WITH A PT ON MUSCLE RE-EDUCATION USING A MUSCLE STIMULATOR. SHE HAD SET UP THE PT USING REUSABLE CONDUCTIVE SELF-ADHESIVE ELECTRODES. THESE ELECTRODES HAD BEEN USED BY THAT PT MANY TIMES BEFORE. THEY WERE FELT TO BE STICKY ENOUGH BY THE THERAPIST TO USE AGAIN. SHE PLACED THEM (4) ON THE PT'S ARM, CONNECTED THEM WELL TO THE LEAD WIRES ON THE UNIT AND PROCEEDED TO PROGRAM THE UNIT. WITHIN THE FIRST MINUTE OF STIMULATION SHE NOTED SMOKING FROM THE ELECTRODE PADS, 2 IN PARTICULAR. SHE IMMEDIATELY TURNED OFF THE MACHINE AND DISCONNECTED THE PT. THE PT FELT NOTHING UNUSUAL AT ALL. THERE WAS NO SKIN REDNESS OR EVIDENCE OF BURN. THE MACHINE WAS CHECKED BY MAINTENANCE AT 4:00 PM THAT DAY. NO OBVIOUS PROBLEMS WERE IDENTIFIED. THE LEAD WIRES ARE ALL FINE. RPTR CONCLUDED THAT THE ELECTRODE PADS MAY HAVE BEEN TOO OLD TO USE. THEY WILL BE IMPLEMENTING A SYSTEM TO MORE CLOSELY MONITOR HOW MANY TIMES THEY USE ELECTRODES WITH EACH PT.
RUPTURE OF SILICONE PROSTHESIS. CAPSULAR CONTRACTURE RIGHT BREAST.
PT STATES THAT FOOT AND HEAD OF BED COLLAPSED SUDDENLY.
OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY, VERNON HILLS, IL 60061. WE RECEIVED ON 2/19/96 NOTIFICATION OF A MEDWATCH CLAIM #MW4001062 REGARDING ONE OF OUR BLOOD PRESSURE UNITS. WITHOUT MORE SPECIFIC INFO REGARDING THE MODEL NUMBER OF THE ITEM IN QUESTION OR THE NAME OF THE COMPLAINANT IT IS NOT POSSIBLE TO SCAN OUR COMPLAINT OR REPAIR DATABASE TO LOCATE AND REVIEW THE HISTORY OF THIS DEVICE. NEVERTHELESS WE HAVE ENTERED THIS COMPLAINT ON OUR COMPLAINT DATABASE NOTING THE FDA AND COMPLAINT NUMBER (4001061) AS A REFERENCE FOR ANY FUTURE CONTACT IN THIS REGARD.
COMPLAINANT SAID THAT COMPANY IS THE SPECIFICATIONS DEVELOPER/DISTRIBUTER OF AN IMPLANTABLE INFUSION PORT USED IN CHEMOTHERAPY THAT THEY COPIED FROM ANOTHER MFR'S PORT. HOWEVER, THE COMPANY IS USING A SILICONE TUBE WHICH IS SHEARING AND GOING INTO THE HEART. REPORTEDLY, THERE HAVE BEEN MANY FAILURES AT SEVERAL HOSPITALS.
DURING A C-SECTION THE TIP OF THE NEEDLE BROKE OFF IN THE PT.
THREE PT APTT RESULTS WERE ERRONEOUSLY HIGH DUE TO VARIATION IN COLOR OF BLUE DISPOSABLE CUVETTES AS MEASURED ON COAGULATION ANALYZER. SOME CUVETTES WERE MUCH LIGHTER IN COLOR AND WERE SHOWN TO PRODUCE A LONGER MEASUREMENT TIME THAN THE STANDARD DARK BLUE COLOR CUVETTES. ONE TEST MEASUREMENT WAS 46.4 SECONDS IN THE LIGHT CUVETTE AND 62.5 SECONDS IN THE DARKER. THIS WAS REPEATED SHOWING 45.4 SECONDS VERSUS 62.4 SECONDS ON THE SAME PT AGAIN. THE INITIAL PROBLEM SHOWED "NO CLOT DETECTED" WHEN RESULTS SHOULD HAVE BEEN 40.6 SECONDS/29.8 SECONDS AND 77.9 SECONDS RESPECTIVELY.
COMPLAINANT HAS USED THE VAPORIZER IN QUESTION FOR 2 YEARS, EACH NIGHT. COMPLAINANT STATED AT 1:00 AM THIS MORNING THE VAPORIZER CORD, STARTED TO SMOKE THEN WENT ON FIRE. HER HUSBAND PUT FIRE OUT AND HE CALLED THE FIRE DEPARTMENT AND RECEIVED INSTRUCTIONS OVER THE PHONE TO CHECK WALL OUTLET ETC AND PER FIRE DEPARTMENT REPRESENTATIVE THE PROBLEM WAS NOT IN THEIR WIRING BUT THE CORD OF THE VAPORIZER. COMPLAINANT FEELS EVERY AGENCY SHOULD KNOW ABOUT THIS DEFECTIVE PRODUCT BECAUSE THEY CAN BE PLACED IN CHILDREN'S BEDROOMS.
A 16FR CHEST TUBE WAS INSERTED FOR TREATMENT OF PNEUMOTHORAX. TWELVE HOURS LATER PT DEVELOPED TENSION PNEUMOTHORAX AND SUB EMPHYSEMA, WITH UNRESOLVED PNEUMOTHORAX. PHYSICIAN FELT TUBING TOO SOFT AND EASILY OCCLUDED BY POSITIONING/TAPING. TUBE REMOVED AND REPLACED BY A DIFFERENT KIND OF TUBE WITH RESOLUTION OF PT SYMPTOMS AND RE-EXPANSION OF THE LUNG.
PT WEIGHED ON BED SCALE, THEN PT TRANSFER ATTEMPTED TO ANOTHER BED WITH PT STILL ON SCALE. SCALE TIPPED, PT SLID TO FLOOR. PT EVALUATED BY MD, X-RAYS ORDERED. RESULTS NEGATIVE.
ON 9/8/95 THE PT WAS PRESCRIBED A MEDICATION AND CONTINUED TO BE GIVEN IT UNTIL 11/24 EVEN THOUGH HE REPEATEDLY INFORMED HIS PHYSICIAN THAT HE WAS HAVING TROUBLE BREATHING. HE ALSO HAD SWELLING OF THE HANDS AND THE HEAD, LOSS OF APPETITE, TROUBLE WITH HIS EYES, AND INVOLUNTARY MOVEMENTS. ON 11/24/95 HE REFUSED TO TAKE ANY MORE MEDICATION AS IT SEEMED THE ONLY WAY TO GET THE ATTENTION OF HIS CARDIOLOGIST. BY THIS TIME MUCH DAMAGE HAD BEEN DONE TO HIS LUNGS, AMONG OTHER THINGS. ON 12/6/95 PT RECEIVED AN IMPLANTABLE CARDIAC DEFIBRILLATOR IN ADDITION TO A PACEMAKER HE HAD RECEIVED IN 7/95. RPTR NOTIFIED PT'S CARDIOLOGIST THERE WAS AN UNUSUAL SPIKE ON HIS MONITOR THAT WAS NOT THERE BEFORE. FROM THE BILLING RECEIVED IT APPEARS THE LEADS ON THE PACEMAKER WERE MOVED. FIVE DAYS LATER AFTER A SEVERE REACTION FROM THE DEFIBRILLATOR PT WAS TOLD HE WAS GOING INTO KIDNEY FAILURE. THE PT PASSED AWAY ON 12/20/95, STILL ASKING FOR A DOCTORS HELP, BECAUSE HE COULD NOT BREATHE. RPTR SINCERELY BELIEVES THAT HE WOULD HAVE LIVED JUST AS LONG, OR LONGER WITHOUT THE MEDICATION OR THE DEFIBRILLATOR. ON 12/11/95 ICD REACTED BY ALMOST KNOCKING PT ACROSS THE ROOM. PLUS THERE WERE 3 MORE SEVERE REACTIONS BEFORE HE COULD REACH HIS BED A SHORT DISTANCE AWAY. ON 12/12/95 THE ICD REACTED 2 TIMES MORE IN THE DOCTOR'S OFFICE. DR PHONED 911 AND RETURNED PT TO HOSPITAL BY AMBULANCE.
BLOOD DETECTED" DISPLAY ALARM NOTED AND BLOOD NOTED IN TUBING. TUBING CLAMPED AND PT TAKEN TO CATH LAB. UNSUCCESSFUL ATTEMPT AT REMOVAL OF IAB IN CATH LAB. PT TAKEN TO SURGERY AND UNDERWENT IAB REMOVAL THROUGH AORTOTOMY.
WE HAVE RECEIVED THE ABOVE REFERENCED MEDWATCH REPORT ON 2/21/96. WE HAVE FORWARDED THE REPORT TO THE MFR OF THIS PRODUCT FOR THEIR REVIEW AND EVALUATION. THE MFR OF TEH PRODUCT IS: ALBAHEALTH PRODUCTS, 201 SOUTH GERMAIN ST, PO BOX 100, VALDESE, NC 28690. ATTN: VICTOR GARROU, TECH DIR. BASED ON THE INFO PROVIDED IN THE MEDWATCH REPORT AND ON INFO FROM THE RPTR, WE HAVE DETERMINED THAT THIS EVENT IS NOT REPORTABLE UNDER THE MEDICAL DEVICE REPORTING REGULATIONS.
THE DEVICE WAS BEING USED FOR CATHETER INSERTION. DURING THE PROCEDURE, THE CRIMPED TIP DISLODGED CAUSING THE CATHETER TO REMAIN IN THE PT. THE PT HAD TO BE TAKEN FOR CYSTOSCOPY FOR REMOVAL OF THE CATHETER.
BAXTER HEALTHCARE CORP, 1430 WAUKEGAN RD, MCGAW PARK, IL 60085-6787. BASED ON THE INFO PROVIDED IN THE MEDWATCH REPORT AND ON INFO FROM THE RPTR, WE HAVE DETERMINED THAT THIS EVENT IS NOT REPORTABLE UNDER THE MEDICAL DEVICE REPORTING REGULATIONS.
PORT BECAME OCCLUDED SHORTLY AFTER IMPLANT. ON RETURN TO OR A SMALL PIECE OF PLASTIC (1X5MM) WAS FOUND IN SYSTEM.
PT FOUND IMPLANT DEFLATED. INTERMITTENT PAIN SAME BREAST (LEFT) SINCE IMPLANTATION. IMPLANT REMOVED/REPLACED ON 9/28/95. ORIGINAL PROCEDURE PERFORMED AT ANOTHER FACILITY.
ON CHEST X-RAY A CATHETER SEGMENT WAS NOTED TO UPPER CHEST. CATHETER WAS INSERTED IN ANOTHER FACILITY. THE CATHETER FRAGMENT WAS REMOVED VIA RIGHT  FEMORAL VEIN WITHOUT ANY COMPLICATIONS.
ON CHEST X-RAY, CATHETER FRAGMENT WAS NOTED WITHIN THE REGION OF THE RIGHT VENTRICLE. THE CATHETER FRAGMENT WAS REMOVED WITHOUT COMPLICATION.
DURING COMPOUNDING, PENCIL-POINT-SIZED HOLES WERE FOUND AT THE TOP LEFT-HAND CORNER OF THE BAG; NOT ON THE SEAM. (ALSO SEE 1008318)
WHEN PLACING PICC LINE, THE PT DEMONSTRATED SYMPTOMS OF HIVES AND FLUSHED APPEARANCE. THE SYMPTOMS SUBSIDED IN ABOUT 10 MINUTES AFTER RECEIVING 25 MG BENADRYL.
DURING COMPOUNDING, PENCIL-POINT-SIZED HOLES WERE FOUND AT THE TOP LEFT-HAND CORNER OF THE BAG; NOT ON THE SEAM. (ALSO SEE 1008317)
UNABLE TO RESTART SYRINGE PUMP ON CRITICAL PT, AFTER CHANGING DOPAMINE SYRINGE. CORRECT RESTART SEQUENCE USED. CORRECT SYRINGE USED. PT WENT TO ASYSTOLE. CHEST OPENED FOR INTERNAL CARDIAC MASSAGE (FRESH OPEN HEART), WHICH WAS SUCCESSFUL. DEVICE RETURNED TO CO FOR TESTING. WRITTEN REPORT OF  11/6/95 FROM CO STATES UNIT TESTED TO PROCEDURE SPECS. NO PROBLEM FOUND.
FRESH OPEN HEART. EXHALATION VALVE ON VENT STAYING CLOSED, NOT ALLOWING EXHALATION. DISCOVERED UNDER FULL ATTENDANCE. VENT DISCONNECTED AND PT BAGGED WITHIN 30 SECONDS. WHEN WEANED FROM VENT POST OP WAS DISORIENTED   AND APHASIC. THORACIC SURGERY RAISED QUESTIONS ABOUT HYPOXIC INJURY. LATER CONFIRMED AS A CVA OF PROBABLE EMBOLIC ORIGIN: THEREFORE, VENT FAILURE DID NOT CONTRIBUTE TO THE ALTERED NEURO STATUS. VENT EXAMINED AND REPAIRED ON SITE BY RT DEPARTMENT. A BACTERIAL FILTER TUBE ON THE EXHALATION SIDE HAD FALLEN OFF, RECONNECTED AND VENT FUNCTIONED TO SPECIFICATION.
PT ADMITTED FOR ENDOMETRIAL ABLATION. AFTER PROCEDURE COMPLETED, SURGEON  REPORTED A PERINEAL BURN.
PT ADMITTED FOR ENDOMETRIAL ABLATION VIA RESECTOSCOPE. AFTER PROCEDURE COMPLETE, SURGEON NOTED PERINEAL BURN.
AT 1600, RN NOTED IV TUBING TO BE DISCONNECTED FROM FEMALE END OF CANNULA (WHICH WAS CONNECTED TO A CENTRAL LINE). RN ESTIMATED BLOOD LOSS TO BE APPROX 150-180 CC. PRIOR TO THE INCIDENT THE PT WAS ORDERED TO RECEIVE PACKED RED BLOOD CELLS. THE PT RECEIVED THE TRANSFUSION THAT EVENING AS ORDERED.
RIGHT-SIDED CATHETER INSERTED INTO SUBCLAVIAN. GUIDEWIRE FRAYED WHILE PHYSICIAN PLACING IT, CHEST X-RAY REVEALED PIECE OF FRAYED GUIDEWIRE IN THE ATRIUM OF THE HEART.
METAL ATTACHMENT PORTION OF TEMPORARY PACEMAKER LEAD BROKEN OFF, HAD TO  STRIP WIRE IN ORDER FOR LEAD TO FUNCTION.
PT PLACED ON ECMO AT 1630 ON 6/24/95. AT 1955, THE ROLLER HEAD OF THE ECMO BLOOD PUMP STOPPED ROTATING WITHOUT SOUNDING ANY ALARMS. ECMO SPECIALIST HAND CRANKED PUMP UNTIL REPLACEMENT PUMP BECAME AVAILABLE. PT'S VITAL SIGNS REMAINED STABLE THROUGHOUT EPISODE.
PT UNDERGOING ESOPHAGOSCOPY, UPON REMOVING THE ESOPHAGEAL DILATOR FROM THE ESOPHOSCOPE, IT WAS NOTED THAT PLASTIC TIP WAS MISSING.
NEEDLE USED TO CLOSE VULVA AND FLAP. NEEDLE TIP BROKE OFF IN VULVA, NEEDLE NOT FOUND.
DRILL BITS BROKE DURING PROCEDURE CAUSING MORE THAN 1 HR. DELAY DUE TO RETRIEVING DRILL BITS.
THE PT HAD A SILICONE BREAST IMPLANT AT ANOTHER FACILITY IN 1987. THE SAME SURGEON WAS INVOLVED. THE IMPLANT WAS SUSPECTED OF LEAKING.
A #3 EMBOLECTOMY CATHETER BROKE AS IT WAS BEING PULLED FROM OPERATIVE SITE. ANOTHER EMBOLECTOMY CATHETER WAS USED TO REMOVE THE WIRE FROM THE FIRST CATHETER. THE PT TOLERATED THE PROCEDURE WITHOUT FURTHER COMPLICATION.
HYGROSCOPIC DILATOR BROKE. PT RETAINED DISTAL PIECES IN UTERUS. THE PT WAS ADMITTED FOR D&C, AND REMAINING PORTIONS WERE SUCCESSFULLY RETRIEVED. NO ADVERSE OUTCOME.
LEFT ANTECUBITAL AREA NOTED TO BE INFILTRATED. AS NURSE WAS REMOVING CATH FROM AFFECTED AREA, IT WAS NOTED THAT THE WHITE CANNULA REMAINED IN THE PT'S BLOOD VESSEL. A SURGICAL CONSULTANT WAS OBTAINED, AND A CUT DOWN WAS SUCCESSFULLY RETRIEVED. THE PT RECEIVED 2 SUTURES.
THE PT HAD A PORT AND CATHETER IMPLANTED ON 12/4/95. WHEN THE PT WENT FOR CHEMOTHERAPY, THE NURSE WAS UNABLE TO GET A BLOOD RETURN. THE PT WAS SENT FOR A PORTACATHOGRAM WHICH SHOWED THE CATHETER SEPARATED AND A PORTION IN THE SVC TO THE RV. THE PT HAD THE PORTION REMOVED SUCCESSFULLY IN RADIOLOGY'S SPECIAL PROCEDURES DEPT. THE PORT WAS REMOVED SURGICALLY AND A NEW PORT INSERTED ON THE OPPOSITE  (R) SIDE OF PT'S CHEST.
A 3 CM PIECE OF GUIDEWIRE WAS SHEARED OFF BY THE NEEDLE. IT EMBOLIZED DOWN TO THE POPLITEAL ARTERY AND WAS SUCCESSFULLY REMOVED WITH A SNARE. THE PT WAS STABLE.
THE PT HAD A LEFT SIDE IMPLANTATION OF A PORT AND CATHETER ON 8/29/95. PRIOR TO THE THIRD DOSE OF CHEMOTHERAPY ON 10/7/95, THE NURSE HAD DIFFICULTY FLUSHING THE LINE. THE PT EXPERIENCED PAIN THAT NIGHT AND SOUGHT TREATMENT. AN X-RAY SHOWED A PORTION OF THE CATHETER IN THE LEFT INNOMINATE VEIN AND EXTENDING INTO THE SVC. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED IN THE RADIOLGY SPECIAL PROCEDURES DEPT. USING A SNARE.
THE PT WAS DUE TO RECEIVE CHEMOTHERAPY THROUGH THIS PORT BUT IT WAS NOTED TO BE FUNCTIONING PROPERLY. AN X-RAY SHOWED A SEPARATION OF THE CATHETER FROM THE PORT. THE PT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF THE PORT AND THEN WENT TO THE RADIOLOGY DEPARTMENT FOR PERCUTANEOUS RETRIEVAL OF A PORTION OF CATHETER FROM THE PT'S RIGHT ATRIUM.
A PT GOT HIS HEAD STUCK IN THE OPENING OF THE SIDERAIL ON THE BED. PT WAS SAFELY RELEASED FROM THE RAIL.
BLOOD LEAKED DURING DIALYSIS. DIALYZER LINES DISCARDED, AND TREATMENT RESUMED. NO FURTHER PROBLEM REPORTED. EBL 200 CC.
THE PT WAS CONFUSED AND MOVING AROUND IN BED. PT MANAGED TO GET HIS HEAD  STUCK IN THE OPENING IN THE BED'S SIDERAIL. PT'S HEAD WAS SAFELY RELEASED FROM THE SIDERAIL.
PT RECEIVED DIALYSIS TREATMENT ON CO MACHINE. ULTRAFILTRATION GOAL SET FOR 1000 ML. TREATMENT TIME 2.5 HOURS. TREATMENT STABLE UNTIL LAST 15 MINUTES OF DIALYSIS TREATMENT. AT THIS TIME BP 54/PALP. PT PALE AND CLAMMY. PLACED IN TRENDELBERG AND 300 CC NORMAL SALINE GIVEN. BLOOD RETURNED. 400 CC NORMAL SALINE GIVEN. OXYGEN THERAPY INITIATED. PLACED ON MARTAR. PT IN SINUS RHYTHM WITH ELEVATED T-WAVES. PT FELT BETTER AFTER BLOOD RETURNED. BP 122/68. PT'S POST WEIGHT WAS 1.6 KG BELOW TARGET WEIGHT. ULTRAFILTRATION REMOVED PER MACHINE 970 CC'S. MACHINE REMOVED AND CHECKED BY CHIEF TECHNICIAN. UF CHIP FOUND TO BE MALFUNCTIONING. CHIP OPERATES UF CALCULATOR. PART OF LP 430 BOARD. BOARD REPLACED, MACHINE RECALIBRATED AND FUNCTIONED PROPERLY. PT DID NOT EXPERIENCE ANY PERMANENT IMPAIRMENT, THOUGH FLUID RESUCITATION WAS REQUIRED. PT DID NOT REQUIRE HOSPITALIZATION. MACHINE HAD BEEN PM'D 11/23/94. UF CALCULATOR FUNCTIONED PROPERLY AT THAT TIME.
CRANIAL DISPOSABLE PERFORATOR TIP DIDN'T STOP AFTER PENETRATING THE SKULL. A SMALL LACERATION OF THE DURA RESULTED. THERE WAS NO NEGATIVE OUTCOME TO THE PT. THE PT'S DURA WAS ABNORMAL AS A RESULT OF HER DISEASE. THE PERFORATOR WAS BEING USED IN CONJUNCTION WITH ANOTHER CO'S CRANIOTOME.
PT AT ABOUT 5 MONTHS POST-OP; BEGAN COMPLAINING OF KNEE PAIN WHEN WALKING AND ALSO AT REST. X-RAYS TAKEN SHOWED KNEE TO BE WELL ALIGNED AND NO SIGNS OF LOOSENING OR OTHER REASON FOR PAIN. PT KEPT COMPLAINING SO PT WAS BROUGHT TO SURGERY AND KNEE WAS RE-OPENED. THE TIBIAL BASEPLATE WAS REMOVED AND REPLACED WITH ONE SIZE SMALLER. THE KNEE WAS THEN CLOSED. THE SURGEON COULD FIND NO REAL REASON WHY THIS PT SHOULD HAVE KNEE PAIN.
PHYSICIAN WAS UTILIZING THE DRILL TO DRILL HOLE IN NASAL CARTILAGE. DRILL BIT END BROKE OFF IN CARTILAGE. PHYSICIAN DECIDED TO LEAVE THE PIECE OF DRILL BIT IN THE NOSE. NO NEGATIVE OUTCOME ANTICIPATED.
A 40 CM STENT DEPLOYED WITH POOR PLACEMENT, 1/2 IN STOMACH AND 1/2 IN ESOPHAGUS. DEVICE WAS PUSHED INTO STOMACH BY PHYSICIAN TO MAKE ROOM FOR 2ND STENT PLACEMENT. A 60 CM STENT PLACED. DURING DEPLOYMENT, TROCAR COVER SHEATH BUNCHED UP, MAKING IT DIFFICULT TO DEPLOY BUT DEPLOYMENT WAS SUCCESSFUL. THE 40 CM STENT WAS LEFT IN PT'S STOMACH.
NURSE ATTEMPTED TO REMOVE FOLEY CATHETER, WITHDREW FROM BALLOON AND PULLED ON CATHETER, MET WITH RESISTANCE. PT COMPLAINED OF EXTREME DISCOMFORT AND PRESSURE IN URETHRA. PHYSICIAN CUT CATHETER IN ATTEMPT TO RELEASE THE FLUID, BUT STILL NO DEFLATE, SO CATHETER WITHDRAWN INTACT.
PT HAD A TIBIAL PLATEAU FRACTURE THAT HEALED INTO VALGUS IN 1983. PT SUBSEQUENTLY HAD A TOTAL REPLACEMENT IN 1986. RECENTLY STARTED COMPLAINING ABOUT KNEE PAIN WITH ACTIVITY. THE PATELLA WAS LATERALLY SUBLUXED AND HAD ANTERIOR KNEE SWELLING AND TENDERNESS. PT WAS BROUGHT TO SURGERY AND THE KNEE WAS OPENED. THE PATELLA WAS WORN THROUGH TO THE METAL BUT WITH NO DAMAGE TO THE FEMORAL COMPONENT. THE 9 MM TIBIAL INSERT WAS REPLACED WITH A 13 MM TIBIAL INSERT AND AN ALL PLASTIC PATELLA.
DURING ROUTINE TEST OF EMERGENCY POWER SYSTEM, VENTILATOR FAILED TO UTILIZE BACK-UP BATTERY POWER TO RETAIN DOCTOR-ORDERED PT SETTINGS AND REVERTED TO FACTORY SETTINGS. WHEN VENTILATOR MEMORY WAS CHECKED, IT INDICATED THE ERROR OCCURRED BUT THE VENTILATOR PASSED THE EXTENDED SELF-TEST AND POWER ON SELF TESTS (INDICATING THE BATTERY WAS OPERATIONAL).
PT COMPLAINED OF PAIN DURING FLEXION/EXTENSION. X-RAYS REVEALED FEMORAL COMPONENT TOO LARGE FOR FEMUR. MEDIUM COMPONENT REMOVED AND REPLACED WITH SMALL FEMUR, 5 MM FULL SPACER AND SMALL STEM EXTENSION.
THREE BUTTONS FAILED TO RESPOND SHORTLY AFTER POWER FAILURE (FROM ELECTRICAL STORM). THIS MALFUNCTION MADE IT IMPOSSIBLE TO SILENCE ALARMS, CHANGE THE LOW VOLUME ALARM SETTING AND CHANGE WAVE FORMS. TWO OTHER VENTILATORS WERE USE AT THE TIME AND NEITHER SUFFERED ANY ILL EFFECTS AFTER THE POWER FAILURE. THIS IS THE SAME VENTILATOR WHICH FAILED DURING POWER FAILURE TEST ON 8/28/95. AFTER THE 8/28/95 FAILURE, THE CPU BOARD WAS REPLACED AND WRITTEN NOTICE RECEIVED FROM CO THAT MACHINE WAS OK TO USE. THIS WAS THE FIRST TIME THIS MACHINE WAS USED SINCE IT HAD BEEN SERVICED; IT HAD BEEN USED ONLY 6 HOURS PRIOR TO MALFUNCTION. THE VENTILATOR WAS PULLED OUT OF SERVICE, TESTED AND REPAIRED WITH HOSPITAL SHARED SERVICES IN OBSERVANCE. IT REMAINS OUT OF SERVICE. TWO PTS DEVELOPED PULMONARY EDEMA FOLLOWING ORTHOPEDIC PROCEDURES. BOTH PTS WERE IN SAME OR, HAD SAME ANESTHESIOLOGIST AND SURGEON. EQUIPMENT USED WAS THE SAME FOR BOTH PTS. TESTING TO DATE ON EQUIPMENT HAS NOT REVEALED ANY PRODUCT PROBLEM.
ONE CYLINDER DEFLATED. UNSURE OF REASON. DEVICE WILL BE EVALUATED BY MFR.
ON 11/2/95 HOSPITAL BED SPONTANEOUSLY RAISED HEAD OF BED UPRIGHT GREATER THAN 90 DEGREES. PT BEGAN EXPERIENCING DECREASED RESPIRATORY EFFORT AND DECREASED SA02. PT INTUBATED AND KEPT ON OXIMETRY AND MONITORING.
ON 7/2/95 PT'S DRAIN TUBING FOUND BY NURSE & REPORTED TO SURGEON THAT DRAIN HAD COME OUT. PT DISCHARGED FROM HOSP ON 7/2. ON 7/29/95 PT READMITTED TO HOSPITAL FOR REMOVAL OF FOREIGN BODY (FLAT PART OR DRAIN THAT WAS STILL IN PT'S BODY). APPARENTLY THE DRAIN CAME APART AT THE JUNCTURE OF THE ROUND TUBING & THE FLAT PERFORATED PORTION.
PT HAD SURGERY ON 8/1/95. PHYSICIAN REMOVED DRAIN ON 8/3/95. X-RAYS MADE ON 8/4/95 REVEALED RETAINED SEGMENT IF TUBING. PT RETURNED TO SURGERY. OPERATIVE REPORT NOTES THAT TUBING WAS BROKEN THROUGH A DRAINAGE HOLE. "THERE WAS NO CLEAR ETIOLOGY AS TO WHY THE DRAIN HAD BROKEN."
PT WAS SCHEDULED FOR A LAPAROSCOPIC TUBAL BANDING. AT LEAST SIX PAIR OF TUBAL OCCLUSION BANDS BROKE DURING PROCEDURE. WAS CONVERTED TO A MINILAPAROTOMY FOR PURPOSES OF TUBAL LIGATION. THE SALES REPRESENTATION WAS NOTIFIED.
PT ADMITTED WITH AORTIC STENOSIS. REQUIRED REPLACEMENT OF AORTIC VALVE WITH TISSUE GRAFT, AS WELL AS, REPLACEMENT OF PULMONARY VALVE WITH TISSUE GRAFT. PULMONARY HOMOGRAFT WAS SMALLER THAN STATED SIZE. THE VALVE DIAMETER WAS 21MM, NOT 23MM AS LABELED. THE MUSCULAR RING ON THE GRAFT HAD TO BE TORN TO ANNULUS TO ACCOMMODATE. PT WAS NOT ADVERSELY AFFECTED. HOWEVER, THERE IS SIGNIFICANT POTENTIAL FOR INJURIES WITH MEASURMENT/LABELLING ERRORS.
PT UNDERGOING TOTAL VAGINAL HYSTERECTOMY. DURING PROCEDURE, ONE  NUMBER 1 CHRONIC GUT ON ATRAUMATIC NEEDLE BROKE OFF APPROX ONE INCH BELOW THE NEEDLE WITH FRAYED AT GUT. THE SUTURE WAS REMOVED. A SECOND SUTURE WAS PLACED AND NOTED TO HAVE UNRAVEELED STRANDS APPROX 6-7 INCHES BELOW THE NEEDLE. WHEN THE SUTURE WAS THEN BROUGHT THROUGH THE PERITONEUM TO BE REMOVED, IT PULLED THE PERITONEUM AND THE BASE OF THE BLADDER AND CAUSED A BLADDER ENTRY. THIS REQUIRED REPAIR THROUGH AN ABDOMINAL APPROACH. THE PT, THEREFORE, HAD TO BE ADD'L SURGERY TO REPAIR THE BLADDER ENTRY CAUSED BY THE SUTURE.
RPTR FOUND BOX OF 5 X 7.5" BAGS WITH NO SPINES. MFR INFORMED. PRODUCT RETURNED AND REPLACEMENT SENT. ALL OTHER BOXES IN DEPARTMENT OPENED, INSPECTED AND ARE CORRECT.
THE SURGERY DEPARTMENT NOTICED SMALL PIECES OF STYROFOAM USED FOR SHIPPING ARE GETTING INTO THE INDIVIDUAL BOXES OF THE PRODUCT. IT ATTACHES ITSELF TO THE PLASTIC COVERING HOUSING THE SYRINGE AND CANNULA TIP. WHEN OPENING THE PLASTIC COVERING, BECAUSE OF STATIC ELECTRICITY, THE SMALL PIECES OF STYROFOAM FALL INTO AND CLING TO THE SYRINGE AND CANNULA TIP WHICH IS CONTMINATING THE DEVICE. RPTR SUGGESTED TO THE MFR THAT THEY USE BUBBLE WRAP TO SHIP THE PRODUCT. THIS WOULD ELIMINATE THIS PROBLEM.
A 2-YEAR-OLD CHRONICALLY ILL GIRL HAD THIS CATHETER PLACED FOR TPN. THE CATHETER BROKE VERY SPONTANEOUSLY AT HOME. THE CATHETER WAS SUCCESSFULLY REPAIRED USING REPAIR KIT DESIGNATED SPECIFICALLY FOR THE CATHETER. REPAIR DID NOT HOLD. THE CATHETER FELL APART WITH EASE AFTER REPAIR ATTEMPT. A DIFFERENT BRAND OF CATHETER WAS SUBSEQUENTLY PLACED.
PT ADMITTED TO EMERGENCY ROOM WITH ACUTE MYOCARDIAL INFARCTION. PHARMACIST WAS IN THE ER RECONSTITUTING THROMBOLYTIC DRUG "ALTEPLASE." 40 ML OF A TOTAL 100 ML WAS PUSHED INTO AN EMPTY 150 ML BAG. PHARMACIST NOTED THAT THE BAG WAS LEAKING FROM THE MIDDLE PORT WHICH WAS IMPROPERLY SEALED. DOSAGE WAS INCORRECT AND DRUG COULD NO LONGER BE USED. ADMINISTRATION OF THE DRUG WAS DELAYED BY 5 - 10 MINUTES WHILE PHARMACIST RETURNED TO THE PHARMACY TO RECONSTITUTE A SECOND VIAL OF THE EXPENSIVE DRUG. THIS COMPROMISED PT CARE.
DEVICE WAS BEING USED IN A CIRCUMCISION. AFTER THE EXCESS FORESKIN WAS EXCISED, THE DEVICE FELL OFF. IT SHOULD HAVE STAYED ON THE PENIS TO CONTROL BLEEDING. THE MECHANISM HAD SPRUNG AND COULD NOT BE TIGHTENED. GEL FOAM AND VASELINE GAUZE APPLIED TO CONTROL BLEEDING.
GAUZE SPONGE WAS OPENED TO CLEAN THE IV HOOD. AN OBVIOUS FUNGAL GROWTH WAS NOTED.
DURING ILEOSTOMY CLOSURE STAPLER MALFUNCTIONED AND FAILED TO FORM STAPLES. DEVICE TO BE RETURNED TO CO FOR EVALUATION.
A BATTERY SUPPORT SYSTEM CAME IN FOR REPAIR WITH WELL #3 INOPERATIVE. UPON CASE REMOVAL, IT WAS DISCOVERED THAT A HOLE HAD BEEN BURNED IN THE 26 CONDUCTOR RIBBON CABLE THAT CONNECTS THE COMPUTATIONAL POWER SUPPLY PCB TO THE DISPLAY PCB. THE RIBBON CABLE HAD BEEN FOLDED AND PLACED ON TOP OF R67 CAUSING THIS BURN. IT APPEARS THAT PLACEMENT OF THE RIBBON CABLE ON TOP OF THIS HIGH WATTAGE RESISTOR IS A POSSIBLE FIRE HAZARD.
PORT BROKE OFF WITH MODERATE TENSION AGAINST IT.
PT HAD TUR ON 7/31/95. PROBLEMS NOTED FOR 5 MONTHS. PT WENT TO OR 1/9/96 FOR KIDNEY STONE. THIS WAS IN ACTUALITY A 3 CM X 0.5 CM RETAINED PIECE OF FOLEY BALLOON WHICH HAD ENCRUSTED.
EVACUATOR USED FOR PT IN THE OPERATING ROOM WOULD NOT REMAIN INFLATED AND HAD TO BE REPLACED.
SURGEON WAS USING THE 20G EXTRUSION CANNULA IN THE ANTERIOR CHAMBER OF THE EYE. IT WAS NOTED THAT THE SILICONE TIP FROM THE EXTRUSION CANNULA HAD COME OFF AND WAS IN THE ANTERIOR CHAMBER AGAINST THE IRIS. MD REMOVED THE CANNULA AND THE SILICONE TIP IN ITS ENTIRETY. NO HARM WAS DONE TO THE EYE. THE CANNULA AND SILICONE TIP WERE PASSED OFF STERILE FIELD AFTER BEING CLEANSED WITH STERILE H2O.
PT UNDERWENT MICROWAVE THERMOTHERAPY. AS OF YESTERDAY PT HAS COMPLETE EJACULATORY DUCT OBSTRUCTION. A REVIEW OF THE LITERATURE SEEMS TO SHOW THAT NO STUDY TO DATE HAS DONE SEMEN ANALYSIS BEFORE AND AFTER MICROWAVE THERMOTHERAPY. RPTR BELIEVES ALL MICROWAVE THERMO THERAPY SHOULD BE BANNED UNTIL THE EFFECT ON SEXUAL FUNCTION AND SEMEN ANALYSIS ARE KNOWN. THE PT WAS NOT INFORMED THAT SUCH A SIDE EFFECT WAS EVEN A POSSIBILITY. EVEN FOR BPH, SEXUAL FUNCTION IS THE MOST IMPORTANT THING TO THE PT AND YET HAS BEEN IGNORED IN STUDIES BY INVESTIGATORS. THIS PT'S INABILITY TO EJACULATE SEMEN IS A TRAGEDY.
DURING CHOLECYSTECTOMY HANDSWITCH REMAINED ACTIVATED AFTER SURGEON REMOVED PRESSURE FROM COAG ACTIVATION BUTTON. MD AND TECH ALSO NOTED A 0.7 CM ARROWHEAD SHAPED CHARRED AREA ON PT'S ABDOMEN APPROXIMATELY 2 INCHES FROM INCISION SITE.
FOUR STAFF MEMBERS EXPERIENCED REDNESS, RASHES, ITCHING, AND EXCESSIVE DRYNESS WHILE USING LATEX EXAM GLOVES. NO MEDICAL TREATMENT NECESSARY. UNABLE TO IDENTIFY MFR BECAUSE LOT NUMBER WAS NOT PROVIDED AND PURCHASED FROM VARIOUS VENDORS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  4.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
REPORTEDLY, BLOOD LEAKED THROUGH DAMAGED GLOVE ONTO NURSES' HAND WHILE EXAMINING AN AIDS PT. UNKNOWN IF MEDICAL TREATMENT WAS REQUIRED. UNKNOWN WHAT SIZE GLOVE WAS WORN DURING EXAMINATION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT UNDERWENT TIBIAL PODDING. SURGEON WENT TO REMOVE SCREWS 10 WEEKS POST-OP DUE TO IRRITATION AND FOUND MOST PROXIMAL OF DISTAL SCREWS HAD BROKEN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS LEAD AND A SECOND LEAD (SAME MODEL) WERE REMOVED FROM SERVICE BECAUSE OF INAPPROPRIATE SENSING. DISTRIBUTOR ASSUMES THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANTED 10/12/92. REMOVED FROM SERVICE 11/29/95. TOTAL IMPLANT TIME 37 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING A ROUTINE CHANGEOUT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM, THIS LEAD AND ANOTHER OF THE SAME MODEL WERE NOTED TO HAVE INSULATION FAILURE. THE LEADS WERE CAPPED. IMPLANT DATE 5/29/92, EXPLANT DATE 11/30/95. TOTAL IMPLANT TIME 42 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS LEAD AND ANOTHER LEAD MODEL WERE REMOVED FROM SERVICE BECAUSE THEY WERE "DEFECTIVE" AND THE PT RECEIVED INAPPROPRIATE SHOCKS. CO ASSUMES THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANTED 12/18/91. REMOVED FROM SERVICE 12/3/95. TOTAL IMPLANT TIME 47 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEAD WAS REMOVED FROM SERVICE BECAUSE "LEAD FRACTURE AT PIN COIL INTER-CONNECT."INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHEN PT WENT TO SIT IN CHAIR, THE SEAT BROKE. PT WAS TAKEN TO ER. PT SUSTAINED FRACTURED HIP.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE ACETABULAR COMPONENT HAD SHIFTED AFTER IT WAS ORIGINALLY IMPLANTED. THE DR DECIDED TO CHANGE THE CUP. HE REMOVED THE STEM BECAUSE OF THE POSSIBILITY THAT THE CEMENT MANTLE HAD BEEN COMPROMISED AFTER THE FIRST REVISION. THE STEM WAS WELL FIXED AND TOOK A LONG TIME TO REMOVE. ANOTHER CUP WAS IMPLANTED AND A STEM WAS CEMENTED INTO PLACE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE ACETABULAR COMPONENT HAD SHIFTED AFTER IT WAS ORIGINALLY IMPLANTED. THE DR DECIDED TO CHANGE THE CUP. HE REMOVED THE STEM BECAUSE OF THE POSSIBILITY THAT THE CEMENT MANTLE HAD BEEN COMPROMISED AFTER THE FIRST REVISION. THE STEM WAS WELL FIXED AND TOOK A LONG TIME TO REMOVE. ANOTHER CUP WAS IMPLANTED AND A STEM WAS CEMENTED INTO PLACE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHILE GIVING RESIDENT HER BATH IN THE TUB, THE NURSING ASSISTANT LIFTED THE CHAIR OUT OF THE WATER AND BEGAN DRAINING WATER FROM TUB. AS THE NURSING ASSISTANT BEGAN TO COVER RESIDENT WITH SHEET, SHE ASKED RESIDENT TO BEND FORWARD SO SHE COULD TUCK SHEET IN BACK. AS RESIDENT BENT FORWARD BELT GAVE WAY AND RESIDENT FELL FORWARD INTO TUB.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  OTHER.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE REPAIRED AND PUT BACK IN SERVICE, INSERVICED BY OTHER FACILITY STAFF.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
STENT IMPLANTATION FOLLOWED ATTEMPTED PTCA WITH FAILURE TO DILATE OF LAD. 2.0 MM STENT WAS DIRECTED DOWN THE MID LAD. ONE INFLATION WAS PERFORMED AT 6 ATM FOR 2 MINUTES. THE BALLOON WOULD NOT DEFLATE. DESPITE INNUMERABLE ATTEMPTS, INCLUDING MANIPULATION OF THE GUIDING CATHETER, THE BALLOON, THE WIRE AND ATTACHMENT OF 50 CC SYRINGE, THE BALLOON REMAINED INFLATED. FINALLY, THE BALLOON WAS OVERINFLATED TO APPROX 14 ATM AT WHICH POINT IT "BURST." THE BALLOON WAS REMOVED FROM THE LAD AND ON THE NEXT INJECTION, EXTRAVASATION OF CONTRAST INTO THE PERICARDIAL SPACE WAS EASILY IDENTIFIED. THE PT UNDERWENT SUBSEQUENT PERICARDIOCENTESIS AND ONE VESSEL CABG. THE PT HAD A GOOD OUTCOME AND WAS DISCHARGED HOME ON THE SIXTH DAY POST-OP. PLAN REVIEW OF FILMS AS PART OF PEER REVIEW PROCESS ON 1/8/96.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  OTHER.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  OTHER.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PT IS A 65-YR-OLD FEMALE WITH UNSTABLE ANGINA WHO WAS EN ROUTE FOR TRANSFER TO HOSP. SHE HAD A BALLOON PUMP IN PLACE. SUDDENLY, THE PUMP READ "AUTOFILL FAILURE" AND WOULD NOT FILL VIA THE MANUAL FILL BUTTON. THE HELIUM TANK WAS FOUND TO BE EMPTY AND A SLOW LEAK AT THE NOZZLE ERRUPTED. THE PT IMMEDIATELY COMPLAINED OF CHEST PAINS AND WAS TAKEN TO THE CCU AT HOSP. SHE WAS RECONNECTED TO A PROPERLY WORKING IABP WITHIN 8 MINUTES. SHE MAY HAVE SUFFERED AN MI AS A RESULT OF THE PUMP FAILURE. SHE HAD SURGERY ON 12/5/95 AT HOSP AND IS STABLE.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-OCT-95.  SERVICE PROVIDED BY:  USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  TELEMETRY FAILURE, OTHER.  CONCLUSION:  DEVICE UNAVAILABLE FOR FOLLOW-UP INVESTIGATION EXAMINATION, NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  MAYBE.  CORRECTIVE ACTIONS:  INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ACCORDING TO THE DISCHARGE SUMMARY, PT WAS ADMITTED TO HOSP IN 1/94 WITH SEVERE CHEST PAIN AND UNDERWENT PACEMAKER IMPLANTATION. A DUAL CHAMBER PACEMAKER WAS INSERTED. PT WENT TO ANOTHER PHYSICIAN COMPLAINING OF PROBLEMS AND PAIN. PHYSICIAN READMITTED PT TO HOSP AND PLACED THE GENERATOR BEHIND THE PECTORALIS MUSCLE TO AVOID THE PAIN OF STRETCHING THE SKIN. PT CONTINUED TO COMPLAIN OF PAIN. ADMITTED TO MEDICAL CENTER FOR EXPLANTATION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  DEVICE FAILED DURING ASSEMBLY.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CNA WAS POSITIONING STRETCHER LIFT SCALE NEXT TO RESIDENT'S BED IN PREPARATION TO TRANSFER RESIDENT INTO BED. CNA STATES HE TURNED AWAY TO CALL FOR 2ND CNA TO ASSIST WITH TRANSFER, AND NOTICED RESIDENT MOVING HANDS IN AIR. AS SHE REACHED, SHE FELL TO FLOOR. CNA STATES ONE STRAP WAS SECURED ABOUT RESIDENT PRIOR TO INCIDENT. RESIDENT TRANSPORTED TO ER VIA AMBULANCE FOR TREATMENT OF LACERATIONS AND HEMATOMA BELOW RIGHT EYE; HEMATOMA RIGHT TEMPORAL AREA; INVOLVEMENT OF SWOLLEN, ECCYMOTIC NOSE. CT SCAN REVEALED NO FRACTURE; ONE SUTURE TO LACERATION BELOW RIGHT EYE. INCIDENT INVESTIGATED IMMEDIATELY. CNA STATES BELT BUCKLE WAS SECURELY LOCKED PRIOR TO INCIDENT. RELEASE OF BUCKLE COULD ONLY BE DONE WHEN BUCKLE BECAME CAUGHT AGAINST FRAME OF STRETCHER. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT INSTRUCTIONS FOR USE CALL FOR TWO BELTS WHEN TRANSPORTING THE RESIDENT - ONE ABOUT THE CHEST, AND ONE ABOUT THE THIGHS. THE BELTS ARE SECURED TO THE STRETCHER IN HOLDERS ON THE UNDERSIDE OF THE STRETCHER. A MEMO STATING THE CORRECT PROCEDURE WAS ISSUED IMMEDIATELY AND STAFF ON DUTY WERE VERBALLY AND VISUALLY GIVEN PROPER INSTRUCTIONS.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-NOV-95.  SERVICE PROVIDED BY:  OTHER.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  FAILURE TO FOLLOW INSTRUCTIONS, INCORRECT TECHNIQUE/PROCEDURE.  CONCLUSION:  USER ERROR CONTRIBUTED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  USER EDUCATION PROVIDED, INSERVICED BY OTHER FACILITY STAFF.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHEN PT WENT INTO V TACH (VENTRICULLAR TACHYCARDIA), THE SYSTEM DID NOT GENERATE A HIGH LEVEL ALARM. THE EVENT WAS NOT DISCOVERED UNTIL ONE OF THE NURSES NOTICED IT ON THE MONITOR SOMETIME AFER THE ONSET OF THE EVENT. THIS PT'S ECG SIGNAL EXHIBITED A WANDERING BASELINE. SINCE THE ARRYTHMIA PORTION OF THIS SYSTEM REQUIRES A STABLE BASELINE TO ANALYZE ACG'S, THE WANDERING BASELINE PREVENTED IT FROM ANALAYZING THE ACG. THE SYSTEM NEVER CAME OUT OF THE LEARNING MODE SINCE IT COULDN'T GET A STABLE REFERENCE ACG. THIS PREVENTED THE HIGH LEVEL ALARMS FROM BEING ACTIVATED. A CALL TO CO CONFIRME THAT THE SYSTEM WAS DESIGNED TO WORK THIS WAY. IT WILL NOT GENERATE A HIGH LEVEL ALARM WHEN IT IS UNABLE TO ANALYZE AN ECG. THE SYSTEM WILL GENERATE A LOW LEVEL ALARM WHICH IS ONLY A BEEP TONE. UNFORTUNATELY, LOW LEVEL ALARMS OCCUR SO FREQUENTLY THAT MOST NURSES IGNORE THEM.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHEN PT WENT INTO V TACH (VENTRICULLAR TACHYCARDIA), THE SYSTEM DID NOT GENERATE A HIGH LEVEL ALARM. THE EVENT WAS NOT DISCOVERED UNTIL ONE OF THE NURSES NOTICED IT ON THE MONITOR SOMETIME AFTER THE ONSET OF THE EVENT. A DEFIBRILLATOR WAS USED TO REVIVE HIM. IT WAS NOT POSSIBLE TO GET THE UNIT CLOSE TO THE PT. THEREFORE THE COILED CORDS ON THE PADDLES HAD TO BE STRETCHED IN EXCESS OF SIX FEET TO REACH THE PT. WHEN AN ATTEMPT WAS MADE TO DEFIBRILLATE THE PT, HE WAS DEFIBRILLATED TWICE, HOWEVER ON THE THIRD ATTEMPT, THE DEFIBRILLATOR WOULD NOT FIRE. THE DEFIBRILLATOR WAS TESTED THOROUGHLY AFTER THIS INCIDENT. IT WAS FOUND THAT WHEN THE PADDLE CABLES WERE STRETCHED TO SIX FEET, THE DEFIB WOULD NOT FIRE. EXAMINING THE PADDLES REVEALED THAT A WIRE ON ONE OF THE PADDLE CABLES WAS BROKEN AS A RESULT OF BEING STRETCHED. THIS UNIT IS FAIRLY NEW AND USED INFREQUENTLY. THEREFORE IT IS NOT BELIEVED THAT THE BREAK OCCURRED AS A RESULT OF EXTENSIVE USE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
VAPORIZER QUIT DISPENSING ANESTHETIC AGENT TO PT WHO WOKE UP DURING CAROTID INDARTARECTOMY. NO INJURY OCCURRED TO PT, HOWEVER AS ANESTHESIOLOGIST TRANSFERRED PT IMMEDIATELY TO ANOTHER ANESTHETIC VAPORIZER AVAILABE ON HIS CART. PT OUTCOME WAS NOT COMPROMIZED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-JUN-95.  SERVICE PROVIDED BY:  FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  DEVICE FAILED DURING ASSEMBLY, DEVICE FAILED DURING ASSEMBLY, OTHER, OTHER.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
AS CATHETER WAS BEING INSERTED, APPROX 1 1/2 INCHES HAD BEEN THREADED WHEN SYMPTOMS BEGAN. PT COMPLAINED OF BACK PAIN AND FACE TURNED RED DOWN TO THE NECK. PT BECAME ANXIOUS MOVING IN BED AND SHORTLY THEREAFTER LOST RED FACE AND NECK BECAME A MOTTLED PURPLE CAST WITH COMPLAINTS OF SHORTNESS OF BREATH STATING "CAN'T BREATHE." ALSO COMPLAINED OF BACK HURTING AND SOME CHEST PAIN. MIDLINE CATHETER IMMEDIATELY REMOVED WHEN PT COMPLAINED OF SHORTNESS OF BREATH. PRESSURE APPLIED TO DISCONTINUED MIDLINE SITE. BP 108/64 P-88 R-18. PT THEN REGAINED PRE-INSERTION PALE COMPLEXION. CHARGE NURSE AND PHYSICIAN IMMEDIATELY NOTIFIED AND IMMEDIATLEY IN TO EVALUATE PT. MD STATED HE FELT IT WAS A REACTION TO THE LANDMARK CATHETER. BENADRYL 25 MG IVP AND DEMEROL 25 MG IVP GIVEN.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE DISCARDED, OTHER, OTHER.  THE DEVICE WAS DESTROYED/DISPOSED OF.
PT ADMITTED FOR LEAD REVISION AFTER DETERMINING ON ROUTINE OUTPATIENT EVALUATION THAT EXISTING TRANSVENOUS PACING LEAD WAS FOUND TO BE FRACTURED. A NEW TRANSVENOUS PACING LEAD WAS IMPLANTED WHILE THIS LEAD WAS CAPPED AND LEFT IN PLACE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, OTHER.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE DISCARDED, OTHER.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE BREAST IMPLANTS WITH CAPSULECTOMIES.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE BREAST IMPLANTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE BILATERAL BREAST IMPLANTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE BREAST IMPLANTS WITH CAPSULECTOMY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BREAST IMPLANT EXCHANGE WITH LEFT CAPSULECTOMY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
INTRA-AORTIC BALLOON DEVELOPED A LEAK. THE BALLOON WAS REPLACED BY THE SURGEON. THE PT WAS NOT INJURED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING A ROUTINE REPLACEMENT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE TWO (RATE SENSING) LEADS WERE REPAIRED AND REMAIN IMPLANTED. IMPLANTED 9/11/92 (IMPLANTED 39 MONTHS).INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM UNDERWENT CARDIAC RELATED SURGERY. DURING THE PROCEDURE, THE TWO (RATE SENSING) LEADS WERE ACCIDENTLY CUT. A NEW BIPOLAR LEAD WAS IMPLANTED. IMPLANTED: 10/2/91. EXPLANTED: 1/3/96 (IMPLANTED 51 MONTHS)INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO OUTPUT. IT ALSO EXHIBITED NO PACING OR SENSING IN THE ATRIAL CHAMBER. IMPLANT DATE 12/29/95. EXPLANT DATE 1/2/96. TOTAL IMPLANT TIME 5 DAYS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THE PT'S TWO MYOCARDIAL RATE SENSING LEADS WERE CAPPED AND REMOVED FROM SVC BECAUSE OF A LEAD INSULATION BREAK. IT IS UNKNOWN WHICH LEAD HAD THE INSULATION BREAK. BOTH LEADS IMPLANTED 12/10/92. CAPPED AND REMOVED FROM SVC 11/27/95.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS SUTURELESS MYOCARDIAL LEAD AND ANOTHER LEAD WERE REMOVED FROM SVC FOR INSULATION FAILURE. THE LEADS ARE CAPPED AND REMAIN IMPLANTED. IMPLANT DATE 7/29/93. OUT OF SVC DATE 9/7/95. TOTAL IN-SERVICE TIME 25 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS LEAD AND ANOTHER MODEL WERE "FOUND TO HAVE VISIBLE SENSING PROBLEMS - EROSION." BOTH LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANTED 9/15/94. REMOVED FROM SVC 12/8/95. TOTAL IMPLANT TIME 14 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING A ROUTINE CHANGEOUT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IDC) THAT THIS LEAD AND ANOTHER MODEL WERE REMOVED FROM SVC FOR INSULATION DAMAGE CAUSED BY THE SURGEON "CUTTING" THE LEADS. THE LEADS ARE CAPPED AND REMAIN IMPLANTED. IMPLANT DATE 11/19/92. EXPLANT DATE 12/5/95. TOTAL IMPLANT TIME 36 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEADS WERE REMOVED FROM SVC BECAUSE OF POOR "R" WAVE MEASUREMENTS AND POOR PACING THRESHOLDS. THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANTED 9/25/92. OUT OF SVC: 12/11/95 (IMPLANTED 38 MONTHS).INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TWO LEADS WERE REMOVED FROM SVC BECAUSE OF A "RATE SENSING LEAD, AND ANOTHER MODEL LEAD, WERE REMOVED FROM SVC BECAUSE OF A "RATE SENSING LEAD PROBLEM OF OVERSENSING AND INAPPROPRIATE SHOCKS." CPI ASSUMES THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANTED 9/14/94. REMOVED FROM SVC APPROX 12/1/95. TOTAL IMPLANT TIME 14 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD SYSTEM EXPERIENCED OVERSENSING/INAPPROPRIATE THERAPY. AN INVASIVE ANALYSIS WAS PERFORMED AND THE PHYSICIAN BELIEVES THE OVERSENSING WAS ATTRIBUTED TO EXCESSIVE SPACING OF THE TWO RATE SENSING LEADS. A NEW BIPOLAR LEAD WAS IMPLANTED. BOTH LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANTED 7/14/92. OUT OF SVC: 12/1/95 (IMPLANTED 40 MONTHS)INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS LEAD AND ANOTHER MODEL WERE REMOVED FROM SVC BECAUSE THE LEADS WERE NOTED TO BE DAMAGED DURING A REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). BOTH LEADS IMPLANTED 11/21/92. REMOVED FROM SVC 12/14/95. IMPLANTED 36 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS MODEL AND A SECOND MODEL LEAD WERE REMOVED FROM SVC AFTER THE PT RECEIVED INAPPROPRIATE SHOCKS FROM HIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANTED 9/13/93. REMOVED FROM SVC 12/11/95. TOTAL IMPLANT TIME 26 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEAD WAS REMOVED FROM SVC FOR LOSS OF ATRIAL SENSING. IMPLANT DATE 4/10/90. REMOVED FROM SVC 11/29/95. TOTAL IMPLANT TIME 67 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING THE ROUTINE REPLACEMENT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AN INSULATION FAILURE WAS OBSERVED ON THE TWO (RATE SENSING) LEADS. THE PHYSICIAN ELECTED TO CAP THE TWO LEADS AND ADD A NEW ENDOCARDIAL (RATE SENSING) LEAD. IMPLANTED: 5/29/92. OUT OF SVC: 11/30/95 (IMPLANTED 42 MONTHS).INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DISTRIBUTOR BECAME AWARE OF AN INCIDENT VIA A MEDWATCH REPORT RECEIVED 12/8/95 OF AN INCIDENT THAT OCCURRED INVOLVING A GUIDE WIRE WHILE PERFORMING A FEMORAL ANGIOGRAM. RESISTANCE WAS ENCOUNTERED UPON WITHDRAWAL OF THE GUIDE WIRE THROUGH AN ENTRY NEEDLE AT THE BEGINNING OF THE PROCEDURE. UPON REMOVAL IT WAS NOTED 3 CM OF COATING HAD SHEARED AND DETACHED IN THE PT. RETRIEVAL OF THE DETACHED SEGMENT FROM THE POPLITEAL ARTERY WAS SUCCESSFUL UTILIZING A SNARE. ANOTHER WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DIRECTIONS FOR USE FOR THIS PRODUCT STATE: "TO AVOID DAMAGE AND POSSIBLE SHEARING OF PLASTIC, DO NOT WITHDRAW OR MANIPULATE THROUGH A METAL CANNULA/METAL DILATOR NOR ADVANCE THE METAL CANNULA/METAL DILATOR. EXTREME CAUTION SHOULD BE OBSERVED WHEN USED WITH A ONEWALL PUNCTURE STYLE NEEDLE."DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE NOT USED AS LABELED/INDENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE DISCARDED.  THE DEVICE WAS DESTROYED/DISPOSED OF.
INSERT HAS SLIGHT WEAR. SURGEON REMOVED ALL COMPONENTS BECAUSE THE KNEE WAS UNSTABLE. PT EXPERIENCING PAIN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
FEMORAL COMPONENT WAS REMOVED BECAUSE KNEE WAS UNSTABLE. PT EXPERIENCING PAIN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
PATELLA HAD DELAMINATED AND BROKEN OFF THE METAL BACKING. SURGEON REMOVED ALL COMPONENTS BECAUSE KNEE WAS UNSTABLE. PT EXPERIENCING PAIN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
REMOVAL OF LEFT RUPTURED IMPLANT AND EXCHANGE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
LEFT BREAST IMPLANT EXCHANGE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BLOOD GLUCOSE TESTED ON MACHINE WITH RESULT OF 28MG/DL. SERUM GLUCOSE DRAWN AND SENT FOR ANALYSIS WITH RESULTS OF 99MG/DL. MACHINE CLEANED AND QUALITY CONTROL PERFORMED WITH NEW BOTTLE OF STRIPS. TESTED AGAINST ANOTHER MACHINE WITH RESULTS ON FIRST MACHINE 58 MG/DL AND RESULTS OF 86/DL ON SECOND MACHINE.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  CRITICAL CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  .  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, VISUAL EXAMINATION, OTHER.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  DEVICE FAILURE DIRECTLY CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TIP OF SUTURE BROKE OFF IN WOUND DURING SUTURING. DR DECLINED X-RAY STATING TIP TOO SMALL TO BE FOUND. PT NOTIFIED OF INCIDENT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, OTHER.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
ARTHROSCOPY IN PROGRESS WHEN PHYSICIAN NOTED METAL SHAVING BEING LEFT IN KNEE BY 5.0 ANGLED BLADE. KNEE FLUSHED. SURGERY CONTINUED WITH NEW BLADE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHEN REMOVING DRAIN, AFTER CLIPPING SUTURES THEN DRAIN BROKE. UNSUCCESSFUL RETRIEVAL ATTEMPTED IN PT ROOM. PT TAKEN TO OR TO SURGICALLY REMOVE REMAINING PART OF DRAIN. NO PERMANENT DAMAGE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
CATHETER THAT HAD BEEN INSERTED JUNE OR JULY 1995 BROKE OFF JUST DISTAL TO PT'S SKIN. NEW CATHETER INSERTED. NO COMPLICATIONS FOR PT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS DESTROYED/DISPOSED OF.
PITUITARY RONGEUR-PIECE BROKE OFF OF JAW DURING PROCEDURE. PIECE WAS IN DISC SPACE. EVENT ADDED 60 MIN TO CASE TO RETRIEVE PIECE.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-APR-95.  SERVICE PROVIDED BY:  INVALID DATA.  SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING CLEANING OF INSTRUMENTS, IT WAS NOTED THAT A PIECE OF INSTRUMENT WAS MISSING FOLLOWING ARTHROSCOPY. INSTRUMENT 5 YRS OLD. X-RAYS TAKEN. UNABLE TO ID PIECE OF METAL IN KNEE. PT AND WIFE INFORMED.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AT CLOSURE OF ABDOMINAL C-SECION IT WAS NOTED THAT APPROX 4 X 5 X 1 MM SEGMENT OF NEEDLE HOLDER WAS MISSING. X-RAY WAS NEG FOR FOREIGN BODY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  THE DEVICE WAS DESTROYED/DISPOSED OF.
DEVICE BEGAN INJECTING MULTIPLE DOSES OF DYE WITHOUT THUMB SWITCH BE DEPRESSED. PT DEVELOPED V-FIB AND REQUIRED DEFIBRILLATION. NO PERMANENT DAMAGE.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  2.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  .  SERVICE PROVIDED BY:  USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT.  SERVICE RECORDS AVAILABLE.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  MECHANICAL TESTS PERFORMED.  RESULTS OF EVALUATION:  EXPECTED WEAR/DETERIORATION.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE REPAIRED AND PUT BACK IN SERVICE.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
THE BUTTON ON INJECTOR CORD STUCK CAUSING THE PT TO RECEIVE MULTIPLE INJECTIONS OF DYE. THE PT FIBRILLATED AND REQUIRED DEFIBRILLATION. NO PERMANENT INJURY.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  2.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  .  SERVICE PROVIDED BY:  USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT.  SERVICE RECORDS AVAILABLE.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  MECHANICAL TESTS PERFORMED.  RESULTS OF EVALUATION:  EXPECTED WEAR/DETERIORATION.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE REPAIRED AND PUT BACK IN SERVICE.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
CATHETER LEAKING. IT WAS NOTED TO HAVE BROKEN OFF JUST PROXIMAL TO HUB. REMAINDER OF CATHETER REMOVED INTACT FROM PT. NO PERMANENT INJURY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  DEVICE TEMPORARILY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CATHETER NOTED TO HAVE BROKEN OFF JUST DISTAL TO INSERTION SITE OF SKIN. DEVICE RETRIEVED. NO PERMANENT INJURY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  MECHANICAL TESTS PERFORMED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
PT HAVING UPPER ENDOSCOPY. PROBE BEING USED FOR CAUTERY. DR REMOVED PROBE FROM SCOPE TO BE CLEANED AND NOTED TIP OF PROBE MISSING. RETRIEVED FROM PT'S STOMACH. PROCEDURE COMPLETED WITH NEW PROBE. NO INJURY TO PT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  MECHANICAL TESTS PERFORMED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS DESTROYED/DISPOSED OF.
AT ABOUT 10:15 AM 12/6/95 PT WAS FOUND BY PHYSICIAN AND RESPIRATORY THERAPIST NON-RESPONSIVE AND WITHOUT PULSE. PT WAS BAGGED. CPR DONE AND 911 CALLED. PHYSICIAN AND RT FOUND THE INNER CANNULA WAS RESTING ON PT'S CHEST. VENTILATOR WAS NOT ALARMING. ONE CNA AND ONE LICENSED NURSE WERE IN PT'S ROOM DOING NURSING CARE TO 2 OTHER PTS BUT DID NOT HEAR ANY VENTILATOR ALARM. VENTILATOR UNIT IS PRESENTLY QUARANTINED AT ADMINISTRATION OFFICE.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-OCT-95.  SERVICE PROVIDED BY:  DISTRIBUTOR.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE TEMPORARILY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PROCEDURE WAS TO REMOVE PROBABLY LIPOMA FROM FOREHEAD. PT'S FOREHEAD WAS PREPPED WITH PHISOHEX AND SALINE. PT WAS DRAPED WITH PLACEMENT OF A OXI-FLOW DELIVERY SYSTEM UNDERNEATH THE DRAPES AT THE NECK. A CONTINUOUS DEPRIVAN DRIP SYSTEM WAS USED FOR SEDATION. CO PRODUCT WAS USED TO EXCISE THE LESION FROM ITS ATTACHMENTS TO THE PERIOSTEUM OR THE FRONTAL CALVARIUM. BOVIE SETTING WERE 40 CUT/20 COAG.  AN ELECTRODE, SWITCHPEN AND ELECTROSURGICAL DISPERSING PAD WERE ALSO USED DURING THE PROCEDURE. DURING THE LAST REMOVAL OF STRANDS OF TISSUE CONNECTING THE LESION TO THE FOREHEAD, A FLASH-TYPE FIRE OCCURRED ACROSS THE SURGICAL FIELD. THE FIRE SEEMED TO ORIGINATE FROM UNDER THE SURGICAL DRAPES. THE FIRE LASTED ONLY SECONDS. THE UPER DRAPES WERE REMOVED AND FIRE WAS NOTED TO THE PLASTIC ON THE OXYGEN DELIVERY SYSTEM. THIS WAS REMOVED FROM THE PT, AND THE FIRE CEASED. THERE WERE BURNS AND CHARRING NOTED TO CLOTH DRAPES/BLANKETS UNDERNEATH THE LARGE PAPER DRAPE. THE PT SUFFERED SUPERFICIAL 1-2 DEGREE BURNS FROM THE SUPRACLAVICULAR AREA ON THE RIGHT, UP ALONG THE FACE TO THE FOREHEAD AND DOWN TO THE EARS BILATERALLY. THERE WAS SINGEING TO THE EYEBROWS, EYE LASHES AND THE ANTERIOR PART OF THE HAIR ON THE HEAD. CORNEAS WERE CHECKED AND THERE WAS NO APPARENT BURNS TO THE CORNEA. THERE ALSO WAS SINGEING TO THE ANTERIOR NASAL HAIRS. COLD WATER AND ICE WERE IMMEDIATELY PLACED ON THE PT'S FACE AND NECK TO DECREASE SEVERITY OF THE BURN. AFTER THE SURGICAL PROCEDURE WAS COMPLETED, THE PT WAS TRANSFERRED TO THE RECOVERY ROOM. NEOSPORIN OINTMENT WAS APPLIED TO PT'S FACE AND NECK, OPTHALMIC OINTMENT WAS APPLIED TO BOTH EYES. THE PT WAS MONITORED CLOSELY FOR RESPIRATORY DISTRESS AND CARDIAC COMPLICATIONS; NONE WERE NOTED. ABG'S WERE DONE, AND THE PT WAS ADMITTED OVERNIGHT FOR OBSERVATION. PT RETURNED TO DR'S OFFICE ON 12/26/95 FOR FURTHER EVALUATION AND EXPRESSED CONCERNS ABOUT BURNS TO FACE. THE CO UNIT WAS EVALUATED BY AN OUTSIDE BIOMEDICAL AGENCY AND THE BOVIE WAS FOUND TO BE FUNCTIONING INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-JAN-95.  SERVICE PROVIDED BY:  INDEPENDENT SERVICE ORGANIZATION.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  TELEMETRY FAILURE, ENVIRONMENTAL FACTORS.  CONCLUSION:  NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, THERE WAS NO DEVICE FAILURE.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TWO (RATE SENSING) LEADS EXPERIENCED OVERSENSING/RECEIVED A DIVERTED SHOCK IN NORMAL SINUS RHYTHM DURING A FOLLOW-UP TEST PROCEDURE. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO REPLACE THE TWO (RATE SENSING) LEADS. BOTH LEADS IMPLANTED 7/1/92. CAPPED AND REMOVED FROM SVC 1/19/96.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SEVENTEEN STAFF MEMBERS EXPERIENCED CRACKING, ITCHING, DRYING OUT, AND SORES ON THEIR HANDS AFTER USING VINYL EXAM GLOVES. ONE STAFF MEMBER WENT TO DOCTOR FOR TREATMENT. DOCTOR FELT REACTION WAS FROM HARD WATER.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  16.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS LADY HAD A HIGH ACTIVITY LEVEL. PT'S KNEE APPEARED TO DRIFT INTO VARUS, RESULTING IN ANTERIOR MEDIAL WEAR OF THE 7MM INSERT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE DISCARDED.  THE DEVICE WAS DESTROYED/DISPOSED OF.
FAILED ACETABULAR COMPONENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
REPLACED WITH 28 MM FEMORAL HEAD FOR 28 MM ACETABULAR COMPONENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE IMPACTOR BROKE WHILE IMPACTING THE TIBIAL INSERT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT EXPERIENCED PAIN AND SWELLING OF LEFT KNEE. X-RAYS WERE TAKEN, TIBIA, TIBIAL INSERT AND PATELLA WERE REVISED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE WRENCH STRIPPED WHILE TIGHTENING THE NUTS ON THE CLAMP.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IPG WAS EXPLANTED BECAUSE OF A "PRODUCT PERFORMANCE ISSUE: BLOOD LEAKING PAST SEAL PLUGS. BLOOD IN GENERATOR-SENSING ISSUE IN ATRIUM VENT." THE IPG HAS BEEN RETURNED FOR ANALYSIS. IMPLANTED 11/5/93. EXPLANTED 12/21/95. TOTAL IMPLANT TIME 25 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT EXPERIENCED PAIN, X-RAYS TAKEN DEMONSTRATED POLY WEAR, TIBIAL COMPONENT WAS REPLACED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
BIPOLAR LEAD AND A PULSE GENERATOR WERE REMOVED FROM SERVICE BECAUSE OF "NONCAPTURE." IT WAS NOTED THAT THIS PT RECENTLY UNDERWENT BOTH AN ABLATION PROCEDURE AND EXPOSURE TO ELECTROCAUTERY. IT IS NOT KNOWN IF THIS LEAD WAS CAPPED OR EXPLANTED. NO OTHER INFO IS AVAILABLE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT RECEIVED "SUSPICIOUS" SHOCKS FROM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE SYSTEM ALSO EXHIBITED HIGH SHOCKING IMPEDANCE READINGS. AN INVASIVE PROCEDURE WAS PERFORMED TO ANALYZE THE SYSTEM. THE PHYSICIAN NOTED VISIBLE INSULATION DAMAGE ON BOTH OF THE SENSING LEADS. TESTING OF THE SHOCKING LEADS REVEALED AN "OPEN CIRCUIT" INDICATING A PROBLEM WITH THE SHOCKING LEAD SYSTEM. THE LEAD SYSTEM WAS REPLACED WITH A TRANSVENOUS LEAD. SERIOUS INJURY MDRS WERE SUBMITTED ON BOTH OF THE SHOCKING LEADS. REFERENCE CO CONTROL NUMBERS 51544 AND 51543 RESPECTIVELY. LEADS IMPLANTED 10/2/92. REMOVED FROM SERVICE APPROX 12/20/95. TOTAL IMPLANT TIME 38 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS LEAD AND ANOTHER OF THE SAME MODEL WERE REMOVED FROM SVC FOR INSULATION FAILURE. IMPLANT DATE 3/16/92. EXPLANT DATE 11/8/95. TOTAL IMPLANT TIME 43 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING A ROUTINE CHANGEOUT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM, THIS LEAD AND ANOTHER OF THE SAME MODEL WERE NOTED TO HAVE INSULATION FAILURE. THE LEADS WERE CAPPED. IMPLANT DATE 5/29/92. EXPLANT DATE 11/30/95. TOTAL IMPLANT TIME 42 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
UNIPOLAR LEAD WAS REMOVED FROM SERVICE FOR A LEAD FRACTURE. IMPLANT DATE 4/15/93. EXPLANT DATE 12/14/95. TOTAL IMPLANT TIME 31 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
BIPOLAR LEAD WAS REMOVED FROM SERVICE BECAUSE OF "NO VENTRICULAR CAPTURE." IMPLANTED 12/13/94. REMOVED FROM SERVICE 12/6/95. TOTAL IMPLANT TIME 11 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEAD WAS REMOVED FROM SERVICE FOR REASONS UNKNOWN. CO WILL ASSUME THE LEAD IS CAPPED AND REMAINS IMPLANTED. IMPLANT DATE 3/3/93. OUT OF SERVICE DATE 12/19/95. TOTAL IN-SERVICE TIME 33 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEAD AND ANOTHER OF THE SAME MODEL WERE REMOVED FROM SERVICE FOR INSULATION FAILURE. IMPLANT DATE 9/17/92. EXPLANT DATE 1/2/96. TOTAL IMPLANT TIME 39 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IABP INSERTED INTO (R) FEMORAL ARTERY. PT IN CARDIOGENIC SHOK. BALLOON WOULD NOT FULLY DEPLOY WITH ATTEMPTS TO FILL, SEVERAL ATTEMPTS AT FILLING WERE MADE. TECHNICAL SERVICES AT CO CONTACTED. STILL UNABLE TO DEPLOY BALLOON. BALLOON ABANDONED. NEW IABP CATHETER INSERTED.
11/16/95 INFILTRATION OF TAXOL AT RIGHT SUBCLAVIAN MEDPORT SITE. INFUSION STOPPED. 11/24/95 X-RAY REVEALED LEAKAGE FROM MED PORT. MEDPORT REMOVED. EXTRAVASATION TO THE RIGHT CHEST WALL HAD OCCURRED.
PT HAD VAGINAL HYSTERECTOMY PARAURETHRAL SUSPENSION, PERCUTANEOUS CYSTOMY, REPAIR OF CYSTOCIL & RETROCIL ON 9/25/95. SUPRAPUBIC CATHETER PLACED. DISCHARGED 9/29/95 WITH CATHETER IN PLACE. CATHETER FELL OUT AT HOME 10/4/95. PT TO ED, #16 FOLEY CATHETER PLACED. DAUGHTER BROUGHT BACK IN ON 1/22/96.
DURING A PRIMARY C-SECTION, AS THE INFANT'S HEAD WAS DELIVERED, THE PHYSICIAN NEEDED TO SUCTION MECONIUM FROM THE ORAL CAVITY. A MUCUS TRAP WAS USED. THE DEVICE BEGAN TO OPERATE APPROPRIATELY THEN STOPPED. THE INFANT ASPIRATED MECONIUM AND WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE NURSERY.
DURING RIGHT ILIAC ARTERY ARTERIOGRAM BALLOON BEGAN TO LEAK AT 8MM AND RUPTURED ON HEAVILY COLLECTED PLAQUE. REMOVED UNEVENTFULLY. WIRE REMAINED IN PLACE TO MAINTAIN ACROSS LUMEN.
DURING ARTERIOGRAM OF THE EXTERNAL ILIAC ARTERY, A 6MM BALLOON WAS USED THE BALLOON RUPTURED ON HEAVILY CALCIFIED PLAQUE BEFORE THE MAXIMUM PRESSURES WERE REACHED. IN ATTEMPTING TO WITHDRAW OVER A 7FR SHEATH, THERE WAS SOME RESISTANCE AND THE DISTAL 1/2 OF THE BALLOON MATERIAL CAME OFF IN THE ARTERY. THE PT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL EMBOLECTOMY.
MANDIBLE IMPLANT PLATE FRACTURED REQUIRING SECOND SURGERY.
CENTRAL VENOUS CATHETER PLACED IN RIGHT SUBCLAVIAN INTRAOPERATIVELY BY ANESTHESIA. POST OPERATIVE X-RAY INDICATED UNUSUAL LINEAR DENSITY. GUIDEWIRE DISCOVERED IN RIGHT SUBCLAVIAN VEIN AGAINST WALL OF RIGHT VENTRICLE. PT ASYMPTOMATIC. GUIDEWIRE REMOVED VIA CARDIAC CATHETERIZATION WITHOUT COMPLICATIONS.
PT HAVING TONSILLECTOMY. UPON SNARING RT TONSIL, WIRE FRACTURED. BOTH PIECES RETRIEVED, NO HARM TO PT.
PHYSICAL THERAPIST ASSISTING PT TO GET UP ON SIDE OF BED. HINGE CLOSURE AROUND TRAPEZE BAR BROKE CAUSING TRIANGLE HAND BAR TO HIT PT ON THE RIGHT TEMPLE AREA. CO REP AT HOSPITAL ON 8/10 AND INSPECTED THIS DEVICE.
PT WAS TAKEN TO SPECIAL PROCEDURES FOR VENA CAVA FILTER. VENOUS ACCESS GAINED WITHOUT COMPLICATION. DELIVERY SHEATH PLACED WITHOUT COMPLICATION. UPON ATTEMPTING TO INSERT DELIVERY DEVICE, SHEATH BUCKLED, NOT ALLOWING FILTER TO BE PLACED. REMOVED SHEATH, ACQUIRED NEW SET, SAME EVENT OCCURRED. REMOVED SECOND SHEATH AND SUCCESSFULLY PLACED A "BIRD'S NEST" TYPE FILTER WITHOUT COMPLICATIONS.
THIS PRODUCT WAS USED IN STARTING A-LINE RIGHT WRIST BY CRNA. WIRE WOULD NOT WITHDRAW AFTER CATHETER IN POSITION. CATHETER AND WIRE REMOVED INTACT AND J WIRE BENT INTO TWO PLACES. SECOND RADIAL CATHETER KIT USED FIR CANNULATION. ANESTHESIA REQUESTED PRODUCT BE REPORTED TO MFR FOR DEFECT.
AFTER RPTR PREPARED THE MAYO & BECK TABLE FOR THE PROCEDURE, RPTR GOWNED & GLOVED DR UPON RETURN TO THE "STERILE FIELD". RPTR NOTICED A "BROWN/BLACK/RUST COLORED DUST" SPRINKLED OVER THE MAYO AND TP DRAPE FROM CHEST LEVEL DOWN. INSTRUMENTS, PT DRAPE AND MAYO WERE CHANGED. DR EXAMINED FIELD, NOTHING WAS NOTED. AT END OF PROCEDURE RPTR WAS INFORMED AIR CONDITIONER SERVICE MAN WAS ON THE ROOF, CHANGING THE FILTER. NO POST-OP WOUND INFECTION. PER EYE OFFICE .
ON 8/5/95 THE 3-11 STAFF TRANSFERRED RESIDENT INTO WHEEL CHAIR WITH LIFT. THE V SHAPED BAR BROKE ON LIFT, THE MAINTENANCE PERSON FELT THE INSIDE OF THE NUT HOLDING WHERE THE TREADS ARE PULLED AWAY FROM THE REST OF THE NUT WHICH ALLOWED THE BOLT TO SLIP OUT THEN CAUSED THE RESIDENT TO DROP. SPOKE WITH MD RESIDENT HAD A FRACTURED RIGHT FEMORAL CONDYLE. HAD ORDERS TO IMMOBILIZE KNEE. SPOKE TO CO QUALITY ASSURANCE, ON 8/11/95. CO SENT A MAINTENANCE INFO SHEET. RESIDENT WAS THE ONLY ONE USING THE LIFT.
PT BROUGHT BACK TO OR. SHUNT LEAKING AT VALVE AREA. APPEARS TO BE A TEAR  UPON REMOVING THE SHUNT.
SMALL PORTION NOTED ON X-RAY TO BE BROKEN OFF IN SPINAL SPACE. REMAINDER OF SHUNT IN PT'S ABDOMEN RLQ. REMAINDER OF SHUNT REMOVED.
DEFLATED LEFT BREAST IMPLANT. REMOVAL OF DEFLATED IMPLANT (LEFT).
RUPTURED TISSUE EXPANDER, RIGHT. REMOVED AND RPLACED WITH 800CC SALINE.
RIGHT TISSUE IMPLANT REMOVED DUE TO BREAST CONTRACTURE. REMOVED AND REPLACED.
THE NEUROSURGEON WAS USING THE SKULL PERFORATOR TO MAKE BURR HOLES. THE PERFORATOR FAILED TO STOP AS IT PERFORATED THE CRANIUM AND CAUSED A TEAR IN THE DURA AND BRAIN TISSUE. SOFT TISSUE TEARS WERE REPAIRED AS PER NORMAL PROCEDURE.
ABBOTT HOSPITAL PRODUCTS DIV. D-389, BLDG AP30, 200 ABBOTT PARK RD, ABBOTT PARK, IL 60064-3537. REQUEST: ANY EVALUATION OR OTHER INFO USED BY YOUR FIRM TO DETERMINE WHETHER THE EVENTS DESCIRBED IN THE MEDICAL DEVICE REPORT AREA OR ARE NOT ATTRIBUTABLE TO THE DEVICE. RESPONSE 1: OTHER THAN THE REPORT SUBMITTED TO US BY THE AGENCY WITH THEIR LETTER OF 2/21/96, WE HAVE NO FURTHER INFO ABOUT THIS EVENT. AS THE REPORTER IS LISTED AS ANONYMOUS, WE CANNOT OBTAIN ADD'L INFO OR REQUEST A SAMPLE FOR ANALYSIS. WE ARE UNABLE TO DETERMINE WHETHER OR NOT THE EVENT IS ATTRIBUTABLE TO OUR DEVICE. REQUEST 2: IF YOUR FIRM HAS DETERMINED THAT THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT IS ATTRIBUTABLE TO THE DEVICE, THEN SUBMIT AN OUTLINE OF THE PLAN FOR REMEDIAL ACTION AND A COPY OF ANY PROPOSED REMEDIAL ACTION COMMUNICATION OR STATE YOUR BASIS FOR DETERMINING THAT REMEDIAL IS UNNECESSARY. RESPONSE 2: AS DISCUSSED IN RESPONSE 1 ABOVE, WE ARE UNABLE TO CONFIRM THE COMPLAINT CONDITION, "MULTIPLE FAILURES OF MFR'S IV EXTENSION SETS." WE ARE UNABLE TO DETERMINE WHETHER OR NOT THE EVENT IS ATTRIBUTABLE TO OUR DEVICE. REMEDIAL ACTION IS NOT DEEMED NECESSARY.
ABBOTT HOSP PRODUCTS DIV. ABBOTT LABORATORIES, D-389, BLDG AP30, 200 ABBOTT PARK RD, ABBOTT PARK, IL 60064-3537. REQUEST 1: ANY EVALUATION OR OTHER INFO USED BY YOUR FIRM TO DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE. RESPONSE 1: OTHER THAN THE REPORT SUBMITTED TO US BY THE AGENCY WITH THEIR LETTER OF 2/21/96, WE HAVE NO FURTHER INFO ABOUT THIS EVENT. AS THE RPTR IS LISTED AS ANONYMOUS, WE CANNOT OBTAIN ADD'L INFO OR REQUEST A SAMPLE FOR ANALYSIS. WE ARE UNABLE TO CONFIRM THE COMPLAINT CONDITION, "MULTIPLE FAILURES OF MFR'S IV EXTENSION SETS." WE ARE UNABLE TO DETERMINE WHETHER OR NOT THE EVENT IS ATTRIBUTABLE TO OUR DEVICE.
ABBOTT HOSPITAL PRODUCTS DIV. ABBOTT LABORATORIES D-389, BLDG AP30, 200 ABBOTT PARK RD, ABBOTT PARK, IL 60064-3537. REQUEST 1: ANY EVALUATION OR OTHER INFO USED BY YOUR FIRM TO DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE. RESPONSE 1: OTHER THAN THE REPORT SUBMITTED TO US BY THE AGENCY WITH THEIR LETTER OF 2/21/96, WE HAVE NO FURTHER INFO ABOUT THIS EVENT. AS THE RPTR IS LISTED AS ANONYMOUS, WE CANNOT OBTAIN ADD'L INFO OR REQUEST A SAMPLE FOR ANALYSIS. WE ARE UNABLE TO CONFIRM THE COMPLAINT CONDITION, "MULTIPLE FAILURES OF MFR'S IV EXTENSION SETS." WE ARE UNABLE TO DETERMINE WHETHER OR NOT THE EVENT IS ATTRIBUTABLE TO OUR DEVICE.
PRODUCT MALFUNCTIONED 2 TIMES IN A 24-HOUR PERIOD; SAME LOT NUMBER. MEMBRANE BURST ON BOTH. "THE FIRST EVENT OCCURRED DURING A ROUTINE CHECK OF THE CIRCUIT. THE PRESSURE TRANSDUCER WAS NOTED TO BE BULGING AWAY FROM THE ACTUAL DISPLAY BOX AND WHEN THE RN WENT TO TIGHTEN THE TRANSDUCER BLEW APART AND BLOOD STARTED BACKING OUT OF THE CIRCUIT UNTIL SHE COULD GET TO  THE STOPCOCK AND TURN IT OFF FROM WHERE IT WAS CONNECTED TO THE OXYGENATOR. THE SILICONE PART OF THE TRANSDUCER WHICH ACTUALLY CONNECTS TO THE PRESSURE BOX JUST EXPLODED INTO LOTS OF LITTLE PIECES AND, OF COURSE, WHEN THAT HAPPENS, YOU HAVE AN OPEN LINE FROM THE CIRCUIT TO THE OUTSIDE WHERE BLOOD LOSS OCCURS AND THIS IS WHAT HAPPENED. APPROX 24 HRS LATER, THE SAME EVENT OCURRED AGAIN DURING A ROUTINE CHECK. THE SPECIALIST NOTED THAT THE TRANSDUCER WAS BULGING FROM THE SILICONE PART AWAY FROM THE PRESSURE BOX AND WENT TO PUT HIS HANDS ON IT SO HE COULD CHECK IT TO SEE IF IT WAS SECURELY TIGHTENED, AND THE SILICONE PART OF THIS TRANSDUCER ALSO BLEW APART INTO MANY PIECES, AGAIN LEAVING AN OPEN CONNECTION FROM THE CIRCUIT TO THE OUTSIDE WHERE BLOOD CAME OUT. RPTR DID CONTACT THE MFR TO REPORT THESE INCIDENTS O THEM, AND THEY HAVE ALREADY SENT TWO NEW PRESSURE BOXES AND WILL BE PICKING RPTR'S UP TO CHECK THEM.
THE PROBLEM OCCURRED ON THE SIDERAIL OF THE CRIB. THE VERTICAL BAR ON THE EXTREME RIGHT SIDE OF THE SIDERAIL BECAME DISLODGED FROM THE TOP HORIZONTAL RAIL. WITH THE VERTICAL BAR IN THIS POSITION, A CHILD PT WAS ABLE TO  REMOVE THE SMALL PLASTIC GROMMET AND REPORTABLY PLACED IT INTO ITS MOUTH AND BECAME TEMPORARILY CHOKED. NO INJURY RESULTED FROM THIS INCIDENT BUT WHERE REMAINS A THREAT OF A SERIOUS INCIDENT WITH THE CRIB(S) IN THEIR PRESENT STATE. ALL CRIBS OF LIKE DESIGN AND MFG HAVE BEEN REMOVED FROM SERVICE PENDING FURTHER COMMUNICATION WITH THE CRIB MFR.
POSSIBLE PRODUCT PROBLEM; DURING ARTHROSCOPY, A SMALL PIECE OF METAL WAS SEEN. RPTR QUESTIONS IF IT BREAKS OFF FROM KNEE SHAVER. 3 POSSIBLE BOXES WITH 3 (PACKAGING NOT SAVED). 1. 95096352, 2. 96015012, 3. 93126682.
SURGEON NOTIFIED PURCHASING DEPT THAT THE HOSPITAL VASCULAR ACCESS SYSTEM CHANGED TO IN AUGUST OF 1995, WAS PRESENTING PROBLEMS. SPECIFICALLY, HE HAS HAD TWO PTS ADMITTED DUE TO THE SYSTEM FAILING (LEAKING). PT'S PORT WAS RECOVERED AND ANOTHER PRODUCT WAS IMPLANTED.
TIDAL VOLUME AT RATE KNOB ROTATED ON SHAFT SO THAT THEY NO LONGER CORRESPONDED WITH INDICATED DIAL SETTINGS. THE VENTILATOR COULD NOT RECOGNIZE TIDAL VOLUME SET. AS A RESULT THE DISPLAY SHOWED ???. THE MACHINE HAD BEEN INITIALLY CHECKED AND UPON SETTING THE VOLUMES THE PROBLEM OCCURRED. THE ANESTHESIOLOGIST FELT NO NEED TO CHANGE THE MACHINE AS THE REMAINDER OF THE ANESTHESIA MACHINE FUNCTIONED NORMALLY. NO HARM OCCURRED TO THE PT. ACCORDING TO THE MFR'S REPAIR RECORD, TIDAL VOLUME AND RATE KNOB POSITION HAVE BEEN ALTERED SO THAT THEY NO LONGER CORRESPOND WITH INDICATED DIAL SETTING. RETURNED TO CORRECT POSITION. KNOBS WERE TIGHT IN THE ALTERED POSITION. POTENTIOMETER SHAFTS SHOWED SIGNS OF SCARRING FROM SET SCREWS. (*)
RESIDENT SUSTAINED A SKIN TEAR REQUIRING SUTURING AFTER GETTING HER RIGHT LEG TANGLED IN THE SIDERAIL. UPON INVESTIGATION STAFF DISCOVERED A SHARP EDGE ON THE BED RAIL. ALL OTHER SIDERAILS IN BUILDING CHECKED AND MANY FOUND TO HAVE A SHARP EDGE AT THE RAILING HINGE. BEDRAILS WERE TAPED WITH FOAM TAPE WHILE WAITING MFR'S INVESTIGATION AND REPLY. ON 2/1/96, ANOTHER RESIDENT SUSTAINED A LACERATION ABOVE THE RIGHT TEMPLE, POSSIBLY ON A SIDERAIL SHARP EDGE. MFR NOTIFIED AGAIN AND INFORMED OF THIS. THEY WILL SEND REPRESENTATIVE TO THE FACILITY.
FOLLOWING THE OPENING OF RPTR'S INSTITUTION THE MFR'S SYSTEM WAS USED EXCLUSIVELY FOR FLUSHING OF CENTRAL VENOUS CATHETERS TO MAINTAIN PATENCY. A HIGHER THAN NORMAL RATE OF CLOT OCCLUSION OF THE CENTRAL VENOUS CATHETERS WERE NOTED. INCREASED DOSAGES OF HEPARIN WERE USED WITH NO SUCCESS. AFTER  DISCUSSION WITH AN IV THERAPY NURSE AT ANOTHER FACILITY THE USE OF THE CATHETERS WERE DISCONTINUED FOR FLUSH OF CENTRAL VENOUS CATHETERS. IMMEDIATELY FOLLOWING THE IMPLEMENTATION OF THIS ACTION THE ISSUE WAS RESOLVED.
RESIDENT WAS FOUND UNRESPONSIVE IN AM, PARTIALLY PRONE POSITION WITH LEGS OVER SIDE RAIL. HER HEAD WAS FACING THE LEFT SIDE WITH THE SOFT WAIST RESTRAINT ON HER RIGHT SHOULDER ACROSS HER BACK TO THE LEFT SIDE. PRIOR TO THE INCIDENT, THE BED WAS SET UP BY A BED CO REPRESENTATIVE IN THE BED. THE STAFF EXPRESSED TO HIM THEIR CONCERN REGARDING THE HEIGHT OF THE BED WITH A STANDARD MATTRESS AND AN EXISTING THREE INCH OVERLAY ON THE MATTRESS. THE CO REPRESENTATIVE STATED "IT IS FINE." THE NURSING STAFF REMOVED THE ADD'L THREE INCH OVERLAY TO REDUCE THE HEIGHT OF THE BED. THE BED WAS TWO-AND-A-HALF TO THREE INCHES BELOW THE SIDE RAIL AFTER THE OVERLAY WAS REMOVED AND THE RESIDENT PLACED ON THE BED. THE HEIGHT OF THE BED REMAINED A CONCERN DUE TO THE RESIDENTS' CONDITION. THE CO ACCOUNT MANAGER CALLED THE DIRECTOR OF NURSING AT APPROX 2:00 P.M. THAT SAME AFTERNOON TO SAY THAT SHE WAS COMING OUT TO CHECK THE BED SINCE SHE WAS NOT SURE THAT THE TECHNICIAN WHO INSTALLED THE BED WAS FAMILIAR WITH IT. THE FACILITY IS NOT AWARE THAT SHE EVER FOLLOWED UP ON THIS CONCERN. AFTER THE INCIDENT, RPTR WAS MADE AWARE THAT A TWO INCH FILLER PAD WAS AVAILABLE TO USE IN PLACE OF THE STANDARD MATTRESS.
RESIDENT WAS FOUND UNRESPONSIVE IN A PARTIALLY PRONE POSITION WITH LEGS OVER SIDE RAIL. HER HEAD WAS FACING THE LEFT SIDE WITH THE SOFT WAIST RESTRAINT ON HER RIGHT SHOULDER ACROSS HER BACK TO THE LEFT SIDE. PRIOR TO THE INCIDENT, THE BED WAS SET UP BY A BED CO REPRESENTATIVE WITHOUT THE RESIDENT IN THE BED. THE STAFF EXPRESSED TO HIM THEIR CONCERN REGARDING THE HEIGHT OF THE BED WITH A STANDARD MATTRESS AND AN EXISTING THREE INCH OVERLAY ON THE MATTRESS. THE CO REPRESENTATIVE STATED "IT IS FINE." THE NURSING STAFF REMOVED THE ADD'L THREE INCH OVERLAY TO REDUCE THE HEIGHT OF THE BED. THE BED WAS TWO-AND-A-HALF TO THREE INCHES BELOW THE SIDE RAIL AFTER THE OVERLAY WAS REMOVED AND THE RESIDENT PLACED ON THE BED. THE HEIGHT OF THE BED REMAINED A CONCERN DUE TO THE RESIDENT'S CONDITION. THE BED CO'S ACCOUNT MANAGER CALLED THE DIRECTOR OF NURSING AT APPROX 2:00 P.M. THAT SAME AFTERNOON TO SAY THAT SHE WAS COMING OUT TO CHECK THE BED SINCE SHE WAS NOT SURE THAT THE TECHNICIAN WHO INSTALLED THE BED WAS FAMILIAR WITH IT. THE FACILITY IS NOT AWARE THAT SHE EVER FOLLOWED UP ON THIS CONCERN. AFTER THE INCIDENT, MFR WAS MADE AWARE THAT A TWO INCH FILLER PAD WAS AVAILABLE TO USE IN PLACE OF THE STANDARD MATTRESS.
STERILE TECHNIQUE FOLLOWED FOR PIC INSERTION AT HOME. MEASURED FOR DEEP VEIN PLACEMENT. VENIPUNCTURE MADE AND CATHETER THREADED EASILY. GUIDE WIRE EASILY REMOVED; GOOD BLOOD RETURN OBTAINED AND LINE FLUSHED WITH 10CC SALINE. PRIMED EXTENSION SET APPLIED AND DRESSED STERILY AS USUAL. VANCOMYCIN INFUSION WAS BEGUN AFTER 25 MINUTES, NOTED PT'S ANTECUBITAL AREA TO BE SWOLLEN, PINK, AND LEAKING FROM EXIT SITE. PIC REMOVED. SMALL PINPOINT LEAK NOTED IN CATHETER WHERE IT WOULD HAVE BEEN IN SUBCUTANEOUS TISSUE BEFORE ENTERING THE VEIN.
PT PRESCRIBED IV TAXOL. PREMEDICATED WITH DECADRON, IV TAGAMET AND IV BENADRYL. AFTER 5 TO 10CC OF TAXOL INFUSED, PT COMPLAINED OF GENERALIZED ITCHING. NO HIVES, NO WHEEZING. VITAL SIGNS STABLE. PT COMPLAINED OF ITCHING AT SITE OF IV. CATHETER INSERTED PRIOR TO INFUSION. PT RECEIVED SOLUCORTEF. IV CATHETER REMOVED AND RESTARTED WITH ANOTHER CATHETER. TAXOL RESUMED WITHOUT FURTHER INCIDENT.
ATTEMPTED EPIDURAL PLACEMENT. BLOOD OBTAINED UPON ASPIRATION. NEEDLE AND CATHETER DC'D. A SLIGHT POP WAS FELT AS CATHETER WAS COMING OUT. EXAMINATION OF CATHETER REVEALED APPROXIMATEY 3.5CM OF CATHETER HAD SHEARED OFF AS CATHETER AND NEEDLE WERE BEING DISCONTINUED. UNABLE TO SEE ON X-RAY ALTHOUGH CO SAYS CATHETER IS RADIOPAQUE.
RPTR HAD SILICONE BREAST IMPLANTS PUT IN IN 1978. SHE HAD INFECTION IN THE SURGICAL AREA. SHE HAD CALCIUM DEPOSITS IN THE RIGHT BREAST. A MEDICAL PROFESSIONAL HAS CONFIRMED SILICONE OUTSIDE THE BREAST SCAR TISSUE CAPSULE. THE IMPLANTS RUPTURED. SHE HAD CAPSULAR CONTRACTIONS AND 2-3 CLOSED CAPSULOTOMIES. SHE COMPLAINED OF LOW BLOOD PRESSURE, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, CARPAL TUNNEL SYNDROME, BRAIN LESIONS, ANXIETY AND/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, DEMENTIA, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, MULTIPLE SCLEROSIS, ATYPICAL M-S, ORGANIC BRAIN SYNDROME, REDUCED BLOOD FLOW TO BRAIN, CHEST/RIB CAGE PAIN AND/OR BURNING SENSATION, ELEVATED CHOLESTEROL OR TRIGLICERIDES, GLAUCOMA, CHRONIC EXTREMITY PAIN, HEAT OR COLD SENSITIVITY OF EXTREMITIES, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA AND/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, MENSTRUAL PROBLEMS-EARLY MENOPAUSAL, OVARIAN PROBLEMS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, FREQUENT MIGRAINES/SEVERE HEADACHES AND PRESSURE, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC THROAT INFECTIONS, BRONCHITIS, COLDS, FLU, CONNECTIVE TISSUE DISEASE, ATYPICAL LUPUS, JOINT INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, CHRONIC UNEXPLAINED MUSCLE SPASMS, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, NON-RESTORATIVE SLEEP, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPS THINGS, MISJUDGES DISTANCE/RUNS INTO OBJECTS, AND SICCA. (*)
FENTANYL SOLUTION OF 20MEQ/ML REPORTEDLY SET PER PUMP TO DELIVER AT 0.5 ML PER HOUR. PUMP ALLEGEDLY OVERINFUSED PT DELIVERING 12.5 ML OVER 2.5 HRS. PT REPORTEDLY RESPONSIVE BUT LETHARGIC. FETANYL DRIP HELD FOR 30 MIN, LETHARGIC EPISODE RESOLVED WITHOUT TREATMENT.
THIS IS A FOLLOW UP REPORT TO CORRECT SOME MISINFORMATION REGARDING UF REP #012513-1996-0006/MF REP #1223466-1996-00001. A FORMALDEHYDE SPILL-PRESUMED 37%-OCCURRED IN THIS DIALYSIS FACILITY. TWO SOURCES WERE IDENTIFIED-A LEAKING SEAL ON A REUSE CART AND A SPILL DOWN THE BACK OF A SHELVING UNIT. THE UNIT WAS EVACUATED, BUT NO ONE WAS SENT TO THE HOSPITAL.
A 63-YEAR-OLD MALE WAS HAVING BILATERAL TOTAL KNEE RECONSTRUCTION PROCEDURE. AFTER RADIOPAQUE BONE CEMENT WAS APPLIED AND TORNIQUET REMOVED, IT WAS NOTICED THE PT BECAME AGITATED AND HAD TO VOMIT. SHORTLY AFTER, THE PT WENT INTO CARDIAC ARREST AND WAS CODED. THE PT'S CONDITION IS NON-RESPONSIVE AND HE IS PRESENTLY ON A VENTILATOR IN THE MEDICAL INTENSIVE CARE UNIT.
SCISSORS BEING USED TO CUT TAPE FROM AN IV ARMBOARD. LEFT BABY FINGER LACERATED AND SUTURES WERE REQUIRED.
SEVERAL PROBLEMS HAVE BEEN ENCOUNTERED WITH THE USE OF THE INFUSION SET INCLUDING: HOLE IN THE CASSETTE, DRIP CHAMBER ASSEMBLED UPSIDE DOWN. HOSP HAS PULLED ALL STOCK WITH SAME LOT NUMBER.
DEFIBRILLATOR MONITOR MALFUNCTIONED DURING A CODE SITUATION. THE MONITOR GAVE INCORRECT READINGS AND CAUSED A MEDICAL PROFESSIONAL TO DEFIBRILLATE THE PT UNNECESSARILY.
DURING PTCA, EXTRACTION ARTHERECTOMY AND STENT IMPLANTATION A STENT WHICH HAD BEEN HAND CRIMPED ONTO A 3.0 BALLOON CATHETER FOR DELIVERY INTO LESION SITE ALLEGEDLY EMBOLIZED SYSTEMICALLY. THE STENT REPORTEDLY WAS NOT IMPLANTED AT THE LESION SITE AND NOT WITHDRAWN WITH THE CATHETER USED DURING THE PROCEDURE. THE STENT WAS NOT VISUALIZED UNDER FLUOROSCOPY. NO TREATMENT WAS REQUIRED PER PHYSICIAN.
DURING PTCA UNSUCCESSFUL ATTEMPT MADE TO IMPLANT STENT. STENT ALLEGEDLY EMBOLIZED SYSTEMICALLY. NO TREATMENT REQUIRED PER PHYSICIAN.
ADMITTED WITH UNSTABLE ANGINA-TO CVL FOR PTCA 7/22/95. MULTIPLE PTCA COMPLETED. BLOOD PRESSURE DROPPED, ATTEMPTED TO START DOPAMINE DRIP VIA PUMP. UNABLE TO ADMINISTER MEDICATION; APPEARED THAT MACHINE WAS WORKING BUT LATER IT WAS DISCOVERED PUMP MECHANISM NOT FUNCTIONING. CASSETTE SWITCHED TO ANOTHER PUMP. MED INFUSED APPROPRIATELY. BLOOD PRESSURE IMPROVED. THIRTEEN MINS LATER ASYSTOLE INITIATED CPR. RHYTHM RESTORED, BP LOW. APPROX 30 MINS LATER, PT'S CONDITION DETERIORATED. PT EXPIRED. WHILE PUMP FAILURE LEAD TO DELAY IN INITIATION OF DOPAMINE, THE PHYSICIAN DOES NOT FEEL THAT THE DELAY WAS CONTRIBUTORY TO THE PT'S DEATH. DOPAMINE WAS INFUSING FOR 13" BEFORE PT WENT ASYSTOLE.
C ARM WAS IN POSITION FOR USE DURING A PROCEDURE. PRIOR TO USE, THE FLUORO INDICATOR ON THE MACHINE ILLUMINATED, INDICATING X RAY EMISSION HAD OCCURRED. NO OPERATOR ACTION INITIATED THE C ARM OUTPUT. FILM BADGES OF EMPLOYEES IN THE IMMEDIATE AREA WERE SENT TO THE VENDOR FOR ANALYSIS. REPORTS RETURNED INDICATE MINIMUM EXPOSURE OR LEVELS THAT ARE UNDETECTABLE. CO SERVICE TECHNICIAN WAS CALLED IN TO DO A FOLLOW UP INSPECTION. THE TECHNICIAN FOUND AND REPLACED A FAULTY FOOTSWITCH.
ON 7/25/94 PT HAD PLACEMENT OF 3 INTERFRAGMENTAL SCREWS AND A 12-HOLE TIBIAL PLATE. ON 1/4/95 PT COMPLETELY HEALED, HARDWARE REMOVED. SCREW HEADS OF THE 3 INTERFRAGMENTAL SCREWS HAD SEPARATED. SCREW SHAFTS HAD TO BE REMOVED WITH HOLLOW MILL SET, BONE THEN GRATED. SENT SCREWS FOR EXAM TO A  METALLURGICAL SERVICES.
ON 1/26/96 ORTHOPEDIC SURGEON REMOVED DRAIN. APPROX 1 1/8" BROKE OFF TIP OF TUBING AND WAS RETAINED IN PT'S KNEE. (POST-OP LEFT TOTAL KNEE  REPLACEMENT). FRAGMENT OF TUBING WAS REMOVED VIA ARTHROTOMY LEFT KNEE IN  THE OPERATING ROOM ON 1/26/96.
THE PT HAD REMOVAL OF BILATERAL BREAST IMPLANTS DUE TO EVIDENCE OF LEAKING. IMPLANTS WERE REPLACED 20 YEARS AGO.
A 26 MM CERVICAL PLATE REMOVED FROM PT'S ANTERIOR CERVICAL SPINE. PLATE WAS IN TWO PIECES.
NON-UNION FRACTURE, DISTAL LEFT RADIUS & ULNA WITH SEVERE DEFORMITY. ON 12/13/95 PT HAD REMOVAL OF DORSAL PLATE AND SCREWS LEFT RADIUS.
S/P BILATERAL SUBMAMMARY POLYURETHANE IMPLANTS ON 2/5/95 WITH SALINE. C/O OF PAIN, AND BURNING ON THE L SIDE WITH FLATTENING IN 12/95. A MAMMAOGRAM ON 12/22/95 REVEALED A RUPTURED L SALINE IMPLANT OF COMPLETE COLLAPSE AS COMPARED TO AN INTACT R SALINE FILLED IMPLANT. IMPLANT WAS DEFLATED AND  NECESSITATED REMOVAL.
A 45 MM CERVICAL PLATE REMOVED FROM PT'S ANTERIOR CERVICAL SPINE. PLATE WAS IN TWO PIECES.
DURING BARIUM ENEMA PROCEDURE, PT'S RIGHT AND LEFT INDEX FINGERS BECAME CAUGHT IN X-RAY TABLE RESULTING IN AMPUTATION OF TIP OF RIGHT INDEX FINGER AND ABRASION OF LEFT INDEX FINGER.
DURING SURGICAL PROCEDURE FOLEY CATHETER WAS INSERTED. DURING INFLATION, THE 30CC BALLOON, RUPTURED AND A PORTION REMAINED IN THE BLADDER. A CYSTOSCOPY WAS PERFORMED TO REMOVE THE PIECE.
SILICONE BREAST IMPLANT REMOVED ON THE ABOVE DATE. THE SECOND SILICONE BREAST IMPLANT WAS REMOVED ON 9/29/95, DUE TO RUPTURE OF RIGHT BREAST IMPLANT PER MRI.
SILICONE BREAST IMPLANTS WITH SUSPICIOUS RUPTURE OF LEFT IMPLANT. IMPLANTED 19 YEARS AGO.
IABP INSERTED POST ANGIOPLASTY. DURING REMOVAL ATTEMPT ON THE FOLLOWING DAY, THE IAB CATHETER BECAME STUCK AND SURGICAL INTERVENTION WAS NECESSARY TO REMOVE THE BALLOON CATHETER. OPERATIVE NOTE INDICATED THAT BALLOON WAS SNAGGED ON HEAVY PLAQUE AT THE BIFURCATION OF THE COMMON ILIAC ARTERY.
ON 11/9/95, A 63-YEAR-OLD GENTLEMAN HAD A SUTURE USED FOR CLOSING AN ABDOMINAL WOUND. THE PT WAS RETURNED TO THE OPERATING ROOM TO CLOSE  EVISCERATED WOUND. AT THAT TIME, IT WAS NOTED THAT THE SUTURE BROKE AND THERE WAS NO TISSUE WEAKNESS.
AT SURGERY BOTH SILICONE BREAST IMPLANTS WERE REMOVED DUE TO RUPTURE.
DURING ATTEMPT TO REMOVE IAB DEVICE IT BECAME LODGED AND REQUIRED SURGICAL INTERVENTION FOR REMOVAL. ABOUT 1 INCH OF BALLOON WAS PULLED OUT WHEN THE CATHETER BECAME LODGED. THE BALLOON WAS CUT IN AN ATTEMPT TO MANIPULATE CATHETER.
DURING A HEPATIC JEJUNOSTOMY, THE STAPLER MISFIRED. ANOTHER WAS OPENED AND USED TO FINISH THE CASE. MFR'S REPRESENTATIVE NOTIFIED.
PT HAS BILATERAL DENSE, GRADE 4 CAPSULAR CONTRACTURE, BOTH BREASTS, WITH BREAST PAIN AND DEFORMITY; HISTORY OF BILATERAL BREAST AUGMENTATION.
DURING GASTRIC BYPASS SURGERY, SURGEON ATTEMPTED TO STAPLE THE STOMACH AND STAPLE DID NOT FORM. SUTURE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. MFR'S REP NOTIFIED.
PT FOR RADIOACTIVE SEED PLACEMENT FOR CANCER OF PROSTATE TREATMENT. UPON REMOVAL OF NEEDLE, NOTED TIP, APPROX  4 CM, BROKEN OFF. ON ROUTINE RADIOLOGIC STUDY TO VERIFY SEED PLACEMENT, NOTED TIP AND 4 PD-103 SEEDS IN PERINEUM. PT REQUIRED SURGERY (NEEDLE LOCALIZATION, FLUOROSCOPY GUIDED) TO REMOVE TIP AND MISPLACED SEEDS.
FOLEY CATHETER WAS INSERTED ON 1/4/96. ON 1/10/96 FOLEY BUL COULD NOT BE DEFLATED. PT WAS TAKEN TO THE OR FOR CYSTOSCOPY AND REMOVAL OF FOLEY CATHETER.
DURING LEFT THORACOSCOPY, STAPLER WAS USED ONCE, THEN REMOVED, RELOADED, AND REINSERTED INTO CHEST TO REUSE. UNABLE TO OPEN INSTRUMENT ON THE SECOND USE. REMOVED FROM SURGICAL FIELD AND SENT TO BIOMEDICAL INSTRUMENTATION FOR EVAL.
ASPEN LABS, 14603 E FREMONT AVE, ENGLEWOOD, CO 80112. INVESTIGATION OF THEJ ABOVE REFERENCED COMPLAINT HAS BEEN COMPLETED. THE ORIGINAL COMPLAINT STATING THAT "DURING C/S IN THE DELIVERY ROOM PENCIL WOULD NOT FIRE ON CUT OR COAG. PENCIL REPLACED, WORKED FINE" WAS RECEIVED 2/5/96 AND THE DEIVCE WAS RECEIVED FOR EVALUATION ON 2/15/96. ASPEN LABS DID NOT FILE A MALFUNCTION MDR ON THIS EVENT BASED ON THE INFO PROVIDED, NO INJURY OCCURRED AND THE NON FUNCTIONING OF A DISPOSABLE DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO SERIOUS INJURY. EVALUATION OF THE DEVICE WAS CONDUCTED AND THE PENCIL WAS CONFIRMED AS HAVING A SOMEWHAT HIGHER THAN NORMAL FORCE TO ACTIVATE BUT DID FUNCTION IN BOTH MODES. OPENING THE PENCIL HOUSING IT WAS DETERMINED THAT THE SWITCH WIRE FORMS WERE NOT PROPERLY ALIGNED TO THE CONTACT WIRE. MFG HAS BEEN INFORMED OF THIS ERROR AND ADVISED TO BE MORE AWARE OF THE CRITERIA.
PT WAS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY. UPON INSERTION OF THE TROCAR INTO THE ABDOMEN THE COMPONENTS OF THE TROCAR BECAME UNASSEMBLED. NO KNOWN INJURY TO THE PT.
INTRA AORTIC BALLOON CATHETER INSERTED ON 10/15/95 FOLLOWING CARDIAC ARREST FUNCTIONED NORMALLY UNTIL THE MORNING OF 10/17/95 WHEN AUTOFILL FAILURE LIGHT CAME ON. BLOOD WAS NOTED IN TUBING SHORTLY THEREAFTER. ATTEMPTS AT REMOVING BALLOON WERE NOT SUCCESSFUL (CIRCULATION BECAME IMPAIRED TO LOWER EXTREMITIES). THE PT REQUIRED SURGICAL REMOVAL OF BALLOON. IAB CATHETER FOUND TO HAVE IMPACTED AT THE ILIAC BIFURCATION.
PT UNDERGOING COLECTOMY-INSTRUMENT FELL APART ON FIELD. NO KNOWN INJURY.
ISOLETTE ALARMED AT 22 DEGREES CELSIUS AND WHEN IMMEDIATELY READ 41 DEGREES CELSIUS. BABY'S TEMPERTURE INCREASED FROM 98.4 DEGREES FARENHEIT TO 100.8 DEGREES FARENHEIT. BABY MOVED TO ANOTHER ISOLETTE. NO OTHER TREATMENT NECESSARY.
RESIDENT WAS BEING TRANSFERED FROM WHEELCHAIR TO BED BY 2 ASSTS, WHEN THE LIFT BROKE. TWO ATTENDING CNA'S LOWERED RESIDENTS TO FLOOR. RESIDENT DIDN'T SUSTAIN ANY INJURIES. IT APPEARS THAT THE CUTTER PIN BROKE ON THE PUMP ARM.
ZIMMER, PO BOX 708, WARSAW, IN 46581-0708. THIS IS TO ACKNOWLEDGE RECEIPT OF YOUR CORRESPONDENCE RELATIVE TO THE SUBJECT MATTER AND TO ADVISE THAT SAME HAS BEEN FORWARDED TO OUR ZIMMER PATIENT CARE DIV AT 200 W OHIO AVE, PO BOX 10, DOVER, OH 44622.
FOLEY CATHETER PLACED IN BLADDER. NURSE INFLATED BALLOON WITH 5C NORMAL SALINE. POP WAS HEARD WITH BRIGHT RED BLOOD RETURN. ATTEMPTED TO WITHDRAW NORMAL SALINE FROM BALLOON AND RETURN WAS BLOOD TINGED. CATHETER REMOVED; BALLOON HAD POPPED. THERE SHOULD HAVE BEEN ONLY 1.5ML INSTILLED. ON LABEL THE PERIOD LOOKED LIKE A COMMA SO THE INDIVIDUAL TOOK IT TO BE 1,5ML RATHER THAN 1.5ML. PRODUCT AND THE PACKAGE LABELED IN THE SAME MANNER. PT HAD HEMATURIA FOR 24 HRS, THEN CLEAR URINE.
UNABLE TO DEFLATE BALLOON ON FOLEY CATHETER CAUSING IT TO BECOME STUCK IN  PENIS. UROLOGIST PLACED 25G NEEDLE INTO PENILE/SCROTAL AREA, BURST THE BALLOON AND REMOVED THE CATHETER. UROLOGIST ALSO INSERTED NEW CATHETER AT THAT TIME. PT WAS ALLEGEDLY PULLING ON FOLEY CATHETER CAUSING BLEEDING FROM URINARY MEATUS PRIOR TO THIS OCCURRENCE. TRANSFERRED TO EXTENDED CARE FACILITY WITH FOLEY CATHETER DRAINING CLEAR YELLOW URINE.
PT UNDERGOING ELECTIVE QUADRUPLE CORONARY BYPASS. TWO PLUS HOURS INTO SURGERY PT SUDDENLY AND WITHOUT WARNING DEMONSTRATED SIGNS OF HEMOLYSIS. AS THE PT HAD NOT RECEIVED ANY BLOOD PRODUCTS AT THIS POINT A BLOOD ANTIBODY REACTION WAS RULED OUT. FOUR TO FIVE UNITS OF RED CELLS WERE ADMINISTERED WITHOUT SEQUELAE AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. POST-OP, THE PT DEMONSTRATED SIGNS OF RENAL FAILURE, AND ON 8/4 ARRESTED 3~AND EXPIRED.
FOUR WAY STOPCOCK ON CENTRAL VENOUS LINE TUBING LEAKED 35-40CC BLOOD FROM CRACK IN PLASTIC. STAT CBC SHOWED DECREASED H&H. PACKED RED BLOOD CELLS, 30CC TRANSFUSED. CBC POST TRANSFUSION WITHIN NORMAL LIMITS. TPN FLUID WITH 18% DEXTROSE AND LIPIDS 20% WERE INFUSING VIA PUMP PRIOR TO OCCURRENCE.
BALLOON CATHETER WAS REMOVED DUE TO RUPTURED TIP. DURING INSERTION OF SECOND CATHETER, SURGEON DISCOVERED THAT THE RIGHT FEMORAL ARTERY HAD TORN DURING REMOVAL OF FIRST CATHETER. A THIRD CATHETER WAS INSERTED INTO THE LEFT FEMORAL ARTERY. PT IS STABLE ON IABP SUPPORT.
DURING A ROUTINE REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PT'S TWO MYOCARDIAL RATE SENSING LEADS WERE CAPPED AND REMOVED FROM SERVICE BECAUSE THE LEADS WERE DISCOLORED AND BLOOD WAS OBSERVED INSIDE THE LEADS. IMPLANTED-6/12/92. REMOVED FROM SERVICE-1/2/96. IMPLANTED-42 MO.
A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXPERIENCED OVERSENSING/INAPPROPIATE SHOCKS. AN INVASIVE ANALYSIS WAS PERFORMED AND THE TWO (RATE SENSING) LEADS WERE CAPPED. A NEW RATE SENSING LEAD WAS IMPLANTED. IMPLANTED: 1/27/93. OUT OF SERVICE: 1/3/96 (IMPLANTED 35 MONTHS).
A PROGRAMMER INTERFACING A HOST COMPUTER WITH A ANALYZER FOR A REFERENCE LABORATORY, ENCOUNTERED A PROBLEM WITH THE INTERFACE SPECIFICATIONS IN THE OPERATORS' AND SERVICE MANUALS OF THE 1ST ANALYZED INSTRUMENT. INQUIRY DATA COMING FROM THE 1ST ANALYZER APPEARS TO BE IN THE SAME FORMAT AS THAT FROM ANOTHER MODEL ANALYZER AND IS IN CONFLICT WITH THE 1ST ANALYZER'S SERVICE  MANUAL. THERE ARE DISCREPANCIES IN HOW THE ANALAYSIS DATA FORMAT IS DESCRIBED E.G., "SERIAL LINE PRINTER" FORMAT OR "TEXT" FORMAT. NO PT RESULTS WERE REPORTED AND INTERFACE OF THE ANALYZER IS PENDING.
DISTRIBUTOR RECEIVED NOTIFICATION OF AN ACCIDENTAL RADIATION OCCURRENCE. DURING SYSTEM INSTALLATION THE FIELD SERVICE ENGINEER CONNECTED A THERMAL PRINTER TO THE SYSTEM. AT THAT POINT THE SYSTEM BEGAN MAKING X-RAYS ON ITS OWN. FSE WAS ABLE TO DIAGNOSE THE FAILURE TO THE X-RAY ON FOOTSWITCH. FSE REMOVED ALL X-RAY ON SWITCHES FROM THE SYSTEM. FSE SENT FOOTSWITCH TO FIELD SERVICE REPAIR CENTER FOR REPAIR AND RETURN. FSE TESTED/INSPECTED  AND RETURNED SYSTEM TO CUURENT SPECIFICATIONS. A FORMAT CORRECTIVE ACTION REQUEST HAS BEEN INITIATED TO INVESTIGATE THIS ISSUE.
THE CANISTER WOULDN'T DRAIN FLUID FROM THE PT'S INCISION POST OPERATION. THE VACUUM CONTROLLER PUMP CONTINUED TO RUN WITHOUT MAKING A SEAL IN THE CANISTER. THE STAFF CHANGED THE PUMP AND STILL NO DRAINAGE OCCURRED. THE CANISTER WAS CHANGED AND THE UNIT OPERATED. THE HOSPITAL IS CONCERNED WITH THE POTENTIAL OF A POSSIBLE HEMATOMA DEVELOPING IN THE ABSENCE OF POST-OP DRAINAGE.
AT THE TIME OF SURGERY THE PATELLA WAS LOOSE AND THE TIBIAL INSERT WAS WORN.
LEAD WAS EXPERIENCING NON-CAPTURE. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE AND FOUND THIS LEAD WAS FRACTURED. IMPLANTED-2/20/95. EXPLANTED-9/27/95. IMPLANTED-7 MO.
LEAD WAS REPLACED BECAUSE OF A FRACTURE. THE LEAD WAS CAPPED AND WILL NOT BE RETURNED TO FOR ANALYSIS. THE LEAD WAS IMPLANTED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MANUFACTURED BY ANOTHER CO DID NOT RECEIVE ANY IMPLANT INFORMATION ON THIS LEAD. IMPLANT DATE-UNKNOWN. REMOVED FROM SERVICE-UNKNOWN.
RESIDENT WAS FOUND IN THE GAP BETWEEN THE UPPER SIDERAIL AND HEAD OF THE BED. RESIDENT WAS FACE DOWN, DRAPED OVER THE MATTRESS FROM THE WAIST UP. HER FACE WAS NEARLY TOUCHING THE FLOOR. WHEN ASSESSED, RESIDENT WAS FOUND TO BE NON-RESPONSIVE TO VERBAL AND TACTILE STIMULI. RIGHT ARM WAS DISCOLORED WITH A 2" LONG GROOVE NOTED ON THE RIGHT FOREARM. ADDITIONALLY THE STERNUM, RIGHT AND LEFT BREASTS WERE REDDENED.
PT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY APPROX FIVE YEARS AGO. PT PRESENTED WITH A SEVERELY PAINFUL AND SWOLLEN RIGHT KNEE AND WAS NOT ABLE TO BEND OR BEAR WEIGHT ON THE KNEE. THE PT WAS ADMITTED TO THE HOSP AND UNDERWENT REVISION OF THE RIGHT TIBIAL INSERT. UPON ENTERING THE JOINT SPACE, THERE WAS A COPIUS AMOUNT OF HEMORRHAGIC FLUID AND CULTURES FOR AEROBES, ANAEROBES, AFB, AND FUNGAL STUDIES WERE OBTAINED. THERE WAS NOTED TO BE WEAR ACROSS BOTH POSTERIOR CONDYLAR ASPECTS OF THE TIBIAL COMPONENT. IT WAS FELT THE ONLY THING THAT NEEDED TO BE REPLACED WAS THE TIBIAL INSERT, WHICH WAS PERFORMED. INTRAOPERATIVE CULTURES WERE REPORTED AS  NEGATIVE. PT UNDERWENT INITIAL TOTAL KNEE REPLACEMENT AT ANOTHER FACILITY DURING 1991.
RN SENT TO PT'S HOME TO ASSESS EXISTING CATHETER. CATHETER HAD MIGRATED OUT EXCEPT FOR 2 INCHES. PT RED ABOVE INSERTION SITE. CATHETER PULLED AND NEW CATHETER INSERTED WITHOUT DIFFICULTY. IMMEDIATELY AFTER PLACEMENT PT COMPLAINED OF FEELING HOT, BECAME UNRESPONSIVE, BP 56/0 PULSE WEAK AND THREADY NO RESPIRATIONS, PUPILS FIXED AND DILATED. CATHETER REMOVED. 911 INITIATED. PT ROUSED WITH VIGOROUS SHAKING AND VITAL SIGNS STABLE AND ANAPHYLACTIC KIT NOT USED, BUT WAS AT HAND. PT TAKEN TO ER AND DISCHARGED AFTER ADMINISTRATION OF IV FLUID.
PT SUSTAINED SEVERE HYPOXIC ISCHEMIC ENCEPHALOPATHY/DEATH DUE TO A VENTRICULAR FIBRILLATION ARREST SECONDARY TO ISCHEMIC CARDIOMYOPATHY AND POSSIBLY INTERNAL CARDIAC PACEMAKER (PM) MALFUNCTION. TRANSCUTANEOUS PM WAS PLACED BY EMERGENCY MEDICAL SERVICES AS THE INTERNAL PM WAS NOT CONTROLLING THE HEART RATE. THE SUSPECT INTERNAL PM HAD BEEN PLACED AT AN OUTSIDE HOSP ON 8/15/91. UNABLE TO DETERMINE IF PT WAS 100% PACEMAKER DEPENDENT. UPON ADMISSION TO FACILITY, INTERROGATION OF THE INTERNAL PM REVEALED THE ATRIAL (A) AND VENTRICULAR (V) LEAD IMPEDANCE WAS >3000 OHMS WITH AMPLITUDE AT 0 VOLTS AND V AMPLITUDE UP TO 7.5 VOLTS WITH PULSE WIDTH UP TO 1.O MS. WITHOUT CAPTURE.
PT HAD 3 LESIONS ON DORSUM OF RIGHT FOOT POST CONTACT WITH O2 SAT PROBE. AT THIS TIME IT IS NOT KNOWN IF THIS IS USER ERROR (NOT CHANGING PROBE SITE) OR EQUIPMENT MALFUNCTION.
PT CHEST X-RAY 2/12/96 SHOWED VASCULAR ACCESS DEVICE CATHETER NOT INTACT. PT WAS ADMITTED TO RPTR'S HOSP, TRANSFERED TO ANOTHER FACILITY FOR CATHETER REMOVAL, AND RETURNED TO RPTR'S FACILITY WITH NO APPARENT COMPLICATIONS.
WHEN ATTEMPTING TO DEPLOY A STENT INTO THE MARGINAL SVC, THE STENT BECAME DISLODGED OFF THE BALLOON. STENT WAS UNABLE TO BE RETRIEVED.
IV PUMP HAS CONSISTENTLY FAILED TO PERFORM PROPERLY; FOUR PUMPS OF THE SAME MODEL HAVE FAILED ON EACH USE IN A PT'S HOME. MALFUNCTIONS RANGE FROM NOT BEING ABLE TO SHUT UNIT OFF; INCONSISTENT INFUSION RATES; JAMMING OR STICKING OF PUMP MECHANISM, TO JUST NOT WORKING AT ALL. THE PUMP HAS BEEN VERY POOR IN PROVIDING RELIABLE IV INFUSION.
DOUBLE LUMEN CATHETER TORE ABOVE BIFURCATION REQUIRING INTERRUPTION OF INTRAVENOUS MEDICATION AND SURGICAL REPLACEMENT.
CATHETER NOTED TO HAVE HOLE DURING CLEANING OF CATHETER SITE. CATHETER SURGICALLY REMOVED AND REPLACED.
MOTORIZED WHEELCHAIR SPINNING OUT OF CONTROL. IN 1994 CONTROLS WERE REPLACED. THE NEW SYSTEM DISCONNECTS EVERY 10 MINS AND IS ALSO CONTINUALLY OUT OF SERVICE. TUBING INAPPROPRIATE CAUSING BREAKDOWN FROM BLOCKAGE OR LEAKAGE. ELECTRONICS, 3 COMPUTER MODULES GRATUITOUSLY COMPLEX. TOO COMPLICATED TO ADJUST, REPAIR, COORDINATE WITHOUT ASSISTANCE FROM RPTR AND REPAIRMAN WILL NOT COME TO HER HOME.
ON 9/11/95 AT 8:15PM, A MORPHINE SULFATE DRIP WAS HUNG AND INFUSION PUMP PROGRAMMED TO RELEASE 2CC PER HOUR. AT 8:20PM, THE INFUSION PUMP ALARMED AND INDICATED "OCCLUSION PT SIDE." UPON INSPECTION, THE IV TUBING AND BOTTLE WAS NOTED TO BE EMPTY. IT WAS DISCOVERED THAT THE PT RECEIVED 100CC OF MORPHINE SULFATE OVER 5 TO 6 MINUTES. THE PT BECAME HYPOTENSIVE AND REQUIRED RESUSCITATION WITH IV FLUIDS, NARCAN AND NEO-SYNEPRINE. THE PT IMMEDIATELY RESPONDED AND BECAME HEMODYNAMICALLY STABLE. THE INFUSION PUMP WAS TAKEN OUT OF SERVICE FOR INSPECTION.
RPTR HAD THE PLATES PUT IN HER BACK AND NOW SHE IS BEGINNING TO LOSE HER BALANCE. SHE FALLS OFTEN NOW, AND IS STILL IN A LOT OF PAIN AND HAS NO FEELING IN HER RIGHT LEG AND CAN'T CONTROL HER BLADDER NOW.
TIP OF CATHETER BROKE OFF INSIDE VEIN OF LEFT ARM.
TEST KIT REAGENT POSITIVE CONTROL IS NONREACTIVE. MULTIPLE KITS HAVE BEEN OPENED AND TESTED. FOUR DISCRETE INCIDENTS ARE DOCUMENTED DURING A TWO-WEEK PERIOD. MFR'S INSTRUCTIONS HAVE BEEN FOLLOWED. MFR HAS BEEN CONSULTED TWICE FOR TECHNICAL ASSISTANCE.
PT FOUND WITH HEAD STUCK IN TOP RIGHT SIDE RAIL THROUGH THE BARS OF THE SIDE RAIL. PT'S HEAD WAS GENTLY REMOVED BY TWO ASSISTANTS. PHYSICIAN EXAMINED PT, PT'S NOSE WAS SWOLLEN AND SLIGHTLY DEVIATED TO RIGHT. PT. WAS WAKE; ALERT ONLY TO A PERSON. NO RESPIRATORY DISTRESS. X-RAYS ORDERED.
PT AT HOME ON TPN WITH PUMP. PT CALLED STATING TUBING WAS LEAKING TPN FLUID ON HER BED. SHE WAS USING 1.2 MICRON LIPID TUBING. PT VERY COMPETENT WITH EQUIPMENT. HAS BEEN USING PRODUCT FOR OVER A YR.
ER PHYSICIAN INSERTED TRIPLE LUMEN CATHETER AND WAS UNABLE TO EXTRACT THE GUIDE WIRE. TRIPLE LUMEN REMOVED. SECOND ATTEMPT TO INSERT TRIPLE LUMEN UNSUCCESSFUL. INSERTED SINGLE LUMEN #16 WITHOUT DIFFICULTY.
PT REPORTS THAT FILTER NEEDLE WAS ATTACHED TO A SYRINGE, THEN THE NEEDLE "FELL OFF THE FILTER/HUB CONNECTOR. PRODUCT RETURNED TO FACILITY WITH NEEDLE SEPARATED FROM FILTER/NEEDLE HUB CONNECTOR.
STAPLE GUN FIRED INCORRECTLY, (STAPLE SHOT TO AN ANGLE AND THEN JAMMED IN  THE GUN), DURING A RIGHT INGUINAL HERNIA PROCEDURE. ANOTHER STAPLE GUN WAS USED TO COMPLETE THE CASE.
DIFFICULTY COMPLETING AN AUTOMATIC DEFIBRILLATOR IMPLANT PROCEDURE. DIFFICULTY IN ESTABLISHING COMMUNICATION BETWEEN IMPLANTED DEVICE AND EXTERNAL PROGRAMMER. AFTER EXHAUSTING SEVERAL ATTEMPTS TO MANIPULATE THE PROGRAMMER'S ANTENNA AND CHANGING DEFIBRILLATORS AND PROGRAMMERS, COMMUNICATION WAS STILL UNSUCCESSFUL. COMMUNICATION WAS ESTABLISHED BEFORE IMPLANTATION. HOWEVER AFTERWARDS IT COULD NOT BE ESTABLISHED USING THE MFR'S SUGGESTED PROTOCOL. THEREFORE, THE PT WAS TRANSFERRED TO A SPECIAL PROCEDURE ROOM AND AFTER MODIFYING THE ANTENNA ORIENTATION, COMMUNICATION WAS ESTABLISHED.
LEFT KNEE SCOPE WITH LATERAL RELEASE PROCEDURE WAS BEING DONE AND THE KNIFE BENT. A SECOND KNIFE WAS USED AND IT BENT. SEE (360072-1995-0011).
DURING DIALYSIS TREATMENT MACHINE ALARMED. BLOOD IN DIALYSATE.
LEFT KNEE SCOPE WITH LATERAL RELEASE PROCEDURE WAS BEING DONE WHEN THE  FIRST KNIFE BENT. (SEE 360072-1995-0010). A SECOND KNIFE WAS USED AND IT BENT ALSO.
PT PREPPED FOR UROLOGICAL SURGERY. PHYSICIAN UNABLE TO OPERATE CAUTERY NURSE CHECKED CAUTERY AND NOTED SMOKE AND FLAMES FROM BACK OF MACHINE. PLUG PULLED. PT TAKEN TO ANOTHER OR. NO HARM TO PT, STAFF OR PHYSICIAN.
AFTER UROLOGICAL SURGERY WAS OVER, SMOKE WAS NOTED FROM CAUTERY. NO INJURY TO PT, PHYSICIAN OR EMPLOYEES. THE CAUTERY MACHINE WAS SET AT 180 CUTTING, 90 COAG AS PER SURGEON'S REQUEST. THESE ARE PER MFG. SPECS. THE LABEL ON THE ELECTRODE STATES: FOR USE WITH SINGLE STEM RESECTOSCOPE.
22-YR-OLD FEMALE UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY 1/29/96. AT COMPLETION OF SURGERY, WHEN SURGEON WAS REMOVING TROCAR SLEEVE FROM PT'S ABDOMEN, SCRUB NURSE NOTICED A SMALL PIECE OF PLASTIC WAS MISSING FROM END OF SLEEVE. SURGEON AND CIRCULATING NURSE AWARE. SURGEON DECLINED TO REOPEN WOUND. X-RAY ORDERED WHICH DID NOT SHOW THE MISSING PIECE. (PLASTIC 6/16" X 6/16"). A VIDEO TAPE OF THE CASE WAS REVIEWED WHICH DID SHOW THE PIECE OF MATERIAL SLIGHTLY SEPARATING AND FINALLY BREAKING OFF, AND FALLING INTO THE ADMOMEN. MFR OF TROCAR NOTIFIED OF INCIDENT BY TELEPHONE. PRODUCT WILL NO LONGER BE USED. PT DISCHARGED 1/30/96. PT WAS NOT AFFECTED.
PT WAS SEEN IN ONCOLOGIST'S OFFICE FOR CHEMOTHERAPY. PORT WAS NOT ABLE TO BE USED AT THE TIME, AND THE PHYSICIAN SENT PT TO THE SURGEON'S OFFICE FOR EVALUATION. THE SURGEON REMOVED THE PORT WITHOUT DIFFICULTY BUT NOTICED THE CATHETER WAS VERIFIED IN THE RIGHT HEART BY X-RAY. ATTEMPTED TO RETRIEVE THE CATHETER BY CARDIAC CATH WITHOUT RESULTS. PT SUBSEQUENTLY WAS ADMITTED TO ANOTHER HOSPITAL FOR REMOVAL SURGICALLY.
PT WAS ADMITTED TO THE HOSP FOR TREATMENT OF PLEURAL EFFUSION ON 8/7/95. THE EFFUSION RESOLVED AND PT WAS DISCHARGED ON 8/13/95, FOLLOWING A ROUND OF ANTIBIOTICS AND PLACEMENT OF CHEST TUBES FOR DRAINAGE. A CT SCAN WAS DONE ON 8/9/95 AND THE RADIOLOGIST NOTICED A PORTION OF THE TUBING FROM A VENOUS ACCESS DEVICE HAD SEPARATED AND MOVED INTO THE RIGHT ATRIUM. THIS WAS NOT REPORTED TO THE ATTENDING PHYSICIAN'S AT THAT TIME. ON A POST-HOSPITALIZATION CHECKUP, A PHYSICIAN NOTED THE TUBING IN THE RIGHT ATRIUM ON A CXR. THE PT WAS REFERRED TO ANOTHER FACILITY FOR REMOVAL OF THE DEVICE.
PT HAD CONTRACTURE-IRREGULARITY IN THE RIGHT BREAST, HAD RECONSTRUCTION.
PT HAD RIGHT BREAST IMPLANT EXCHANGE IN 11/93 FOR CAPSULAR CONTRACTURE. HAD SURGERY ON 1/30/96 FOR DEFLATED RIGHT IMPLANT.
RPTR HAD SILICONE BREAST IMPLANTS INSERTED ON 9/27/77. SHE HAS ILLNESSES, NEUROLOGICAL, PSYCHOLOGICAL, PHYSICAL, RHEUMATIC. SHE ALSO HAS SEIZURES. SHE HAD IMPLANTS REMOVED ON 1/10/96. IMPLANTS RUPTURED. SHE HAD 2 SEVERE CAPSULAR CONTRACTURES. CALCIFIED AREAS 1/16/96.
RPTR HAS BEEN A DENTAL HYGIENIST FOR 22 YRS. IN THE LAST COUPLE OF YRS, SHE HAS BECOME SENSITIZED TO LATEX PRODUCTS. SHE ORIGINALLY EXPERIENCED AN OCCASIONAL RASH ON HER HANDS. SHE WAS NOT AWARE THAT ONE COULD BECOME SO ALLERGIC TO LATEX THAT COMPLETE AVOIDANCE WOULD BE NECESSARY. SHE NOW HAS LATEX SPECIFIC IGE IN HER BLOODSTREAM. SHE HAS A TYPE 1 ALLERGY THAT HAS COST HER HER DENTAL HYGIENE CAREER, AND MAKES IT DIFFICULT TO LEAD A NORMAL LIFE. SHE BEGAN TO EXPERIENCE BREATHING PROBLEMS, AN INTERMITTENT, UNCONTROLLABLE DRY COUGH, RED ITCHY EYES, AND A BODY RASH AND STARTED TO BREAK OUT WITHIN 10 MINS OF DONNING LATEX GLOVES. HER HANDS AND WRISTS WOULD DEVELOP HIVES, TURN BRIGHT RED AND ITCH LIKE CRAZY. NOT REALIZING THAT SHE HAD A TYPE 1 ALLERGY THE CLINIC ORDERED A DIFFERENT BRAND OF LATEX GLOVES. IT TOOK ABOUT A WEEK AND A HALF BEFORE SHE BEGAN TO BREAK OUT. THE RESEARCH SHE HAS READ INDICATES THAT THIS IS A HEALTH PROBLEM THAT IS ON THE RISE. HEALTHCARE WORKERS ARE AT HIGH RISK. INDIVIDUALS WITH A HISTORY OF DERMATITIS AND OTHER ALLERGIES ARE AT MORE RISK. THERE ARE CROSS ALLERGENS: KIWI, AVOCADO, CHESTNUTS AND BANANAS. PEOPLE WITH ALLERGIES TO THESE FOODS ARE ALSO AT RISK. THERE NEEDS TO BE SOME KIND OF WAY TO EVALUATE WHAT PRODUCTS CONTAIN LATEX AND HOW MUCH OF IT BEFORE HOSPITALS AND EMERGENCY SERVICES CAN DEVELOP LATEX-FREE PROTOCOLS. AT THIS POINT IN TIME IT IS DIFFICULT TO DO SO. HAD SHE UNDERSTOOD THE SIGNS AND KNOWN THAT SHE COULD BECOME THIS ALLERGIC, SHE MIGHT HAVE BEEN ABLE TO TAKE ACTION SOONER AND AVOID THE CONSEQUENCES SHE NOW FACES WITH A TYPE 1 ALLERGY. (ALSO SEE 1008363.)
RPTR HAS BEEN A DENTAL HYGIENIST FOR 22 YEARS. IN THE LAST COUPLE OF YEARS  SHE HAS BECOME SENSITIZED TO LATEX PRODUCTS. SHE ORIGINALLY EXPERIENCED AN OCCASIONAL RASH ON HER HANDS. SHE WAS NOT AWARE THAT ONE COULD BECOME SO ALLERGIC TO LATEX THAT COMPLETE AVOIDANCE WOULD BE NECESSARY. SHE HAS LATEX SPECIFIC IGE IN HER BLOODSTREAM. SHE HAS A TYPE 1 ALLERGY THAT HAS COST HER DENTAL HYGIENE CAREER, AND MAKES IT DIFFICULT TO LEAD A NORMAL LIFE. SHE BEGAN TO EXPERIENCE BREATHING PROBLEMS; AN INTERMITTENT UNCONTROLLABLE DRY COUGH, RED ITCHY EYES, A BODY RASH AND STARTED TO BREAK OUT WITHIN 10 MINUTES OF LATEX GLOVES. HER HANDS AND WRISTS WOULD DEVELOP HIVES, TURN BRIGHT RED AND ITCH LIKE CRAZY. NOT REALIZINZG THEAT SHE HAD A TYPE 1 ALLERGY THE CLINIC ORDERED A DIFFERENT BRAND OF LATEX GLOVES. IT TOOK ABOUT A WEEK AND A HALF BEFORE SHE BEGAN TO BREAK OUT. THE RESEARCH SHE HAS READ INDICATES THAT THIS IS A HEALTH PROBLEM THAT IS ON THE RISE. HEALTHCARE WORKERS ARE AT HIGH RISK. INDIVIDUALS WITH A HISTORY OF DERMATITIS AND OTHER ALLERGIES ARE AT MORE RISK. THERE ARE CROSS ALLERGENS: KIWI, AVOCADO, CHESTNUTS AND BANANAS. PEOPLE WITH ALLERGIES TO THESE FOODS ARE ALSO AT RISK. THERE NEEDS TO BE SOME KIND OF WAY TO EVALUATE WHAT PRODUCTS CONTAIN LATEX AND HOW MUCH OF IT BEFORE HOSPITALS AND EMERGENCY SERVICES CAN DEVELOP LATEX-FREE PROTOCOLS. AT THIS POINT IN TIME IT IS DIFFICULT TO DO SO. HAS SHE UNDERSTOOD THE SIGNS AND KNOWN THAT SHE COULD BECOME THIS ALLERGIC, SHE MIGHT HAVE BEEN ABLE TO TAKE ACTION SOONER AND AVOID THE CONSEQUENCES SHE NOW FACES WITH A TYPE 1 ALLERGY.
PT WAS OPERATED ON 10/6/95 FOR VAGINAL HYSTERECTOMY; BILATERAL SALPINGO-OOPHORECTOMY; ANTERIOR REPAIR; POSTERIOR REPAIR; PERINEORRHAPHY; AND PLACEMENT OF SUPRAPUBIC CATHETER. PT WAS SENT HOME WITH CATHETER IN AND ON 11/4/95 THE CATHETER BROKE OFF. PT RETURNED TO HOSPITAL FOR REMOVAL OF CATHETER AND PT NOW CATHERIZES HERSELF EACH DAY AS SHE IS UNABLE TO URINATE.
THE X-RAY CATHODE IS SEALED IN OIL TO PROTECT AGAINST OVERHEATING. WHEN THE X-RAY HEAD WAS FIRST INSTALLED THERE WAS AN OIL LEAK IN THE HEAD. WHEN THE MFR WAS NOTIFIED THEY SAID IT WAS PACKED IN OIL. THE LEAK BECAME WORSE AND RPTR HAD TO REPLACE THE HEAD WHEN IT WAS ONLY THREE YEARS OLD. RPTR IS CONCERNED BECAUSE IT COULD EXPLODE.
THE DEVICE MALFUNCTIONED IN THE HALLWAY OF THE SCHOOL. IT CHARGED FORWARD.
PCA EXTENSION SET WAS LEAKING AT END BEFORE RUBBER. NO PT INJURY.
AFTER THE PUMP IS SET, THE MEDICATION CASSETTE IS INSERTED AND THE PUMP IS TURNED ON, IT HAS BEEN NOTED ON SEVERAL OCCASIONS THAT THE PUMP WILL APPEAR TO BE INFUSING THE MEDICATION AS THE LIGHT FLASHES, AND IT READS OUT NUMBERS INDICATING THAT THE MEDICATION IS BEING ADMINISTERED. HOWEVER, WHEN THE PT COMPLAINS OF PAIN, AND AN INVESTIGATION IS DONE, THE MEDICATION CASSETTE IS STILL FULL. IT IS ULTIMATELY DISCOVERED THAT, DUE TO USER ERROR, THERE IS AN "UPSTREAM OBSTRUCTION" SUCH AS A KINK IN THE TUBING OR A CLAMP LEFT ON THE CASSETTE. A NURSE LOOKING AT THE PUMP WOULD INITIALLY THINK THAT THE MEDICATION IS INFUSING AS THERE IS NO ALARM, NOR DOES THE PUMP APPEAR TO BE HAMPERED IN ITS DELIVERY OF MEDS. THIS HAS OCCASIONALLY LEFT THE PT IN PAIN FOR VARYING LENGTHS OF TIME. SINCE THE PUMPS ALARM WHEN THERE IS A "DOWNSTEAM" OCCLUSION, IT WOULD SEEM LOGICAL THAT AN ALARM COULD BE SOUNDED WHEN THERE IS AN "UPSTREAM" OCCLUSION, OR AT THE VERY LEAST, THE PUMP COULD GO ON "HOLD" AND NOT INDICATE THAT THE MEDICATION IS INFUSING.
PT WAS FOUND WITH FACE BETWEEN THE UPPER RIGHT SIDE RAIL AND REST OF BODY  ON THE FLOOR. RESIDENT PRONOUNCED DEAD AT THE SCENE BY PHYSICIAN AND  MEDICAL EXAMINER. AWAITING CORONER'S REPORT.
AFTER THE PUMP IS SET, THE MEDICATION CASSETTE IS INSERTED AND THE PUMP IS TURNED ON, IT HAS BEEN NOTED ON SEVERAL OCCASIONS THAT THE PUMP WILL APPEAR TO BE INFUSING THE MEDICATION AS THE LIGHT FLASHES, AND IT READS OUT NUMBERS INDICATING THAT THE MEDICATION IS BEING ADMINISTERED. HOWEVER, WHEN THE PT COMPLAINS OF PAIN, AND AN INVESTIGATION IS DONE, THE MEDICATION CASSETTE IS STILL FULL. IT IS ULTIMATELY DISCOVERED THAT, DUE TO USER ERROR, THERE IS AN "UPSTREAM OBSTRUCTION" SUCH AS A KINK IN THE TUBING OR A CLAMP LEFT ON THE CASSETTE. A NURSE LOOKING AT THE PUMP WOULD INITIALLY THINK THAT THE MEDICATION IS INFUSING AS THERE IS NO ALARM, NOR DOES THE PUMP APPEAR TO BE HAMPERED IN ITS DELIVERY OF MEDS. THIS HAS OCCASIONALLY LEFT THE PT IN PAIN FOR VARYING LENGTHS OF TIME. SINCE THE PUMP'S ALARM WHEN THERE IS A "DOWNSTEAM" OCCLUSION, IT WOULD SEEM LOGICAL THAT AN ALARM COULD BE SOUNDED WHEN THERE IS AN "UPSTREAM" OCCLUSION, OR AT THE VERY LEAST, THE PUMP COULD GO ON "HOLD" AND NOT INDICATE THAT THE MEDICATION IS INFUSING.
PT USING STANDING TABLE. PT STATES HE SLIPPED OR SLID TO THE GROUND. PT SEEN BY ATTENDING PHYSICIAN. NO APPARENT TRAUMA TO THE HEAD.
ON 1/30/92 RPTR FELL ABOUT 5FT FROM THE REAR OF A TRUCK, LANDING ON HIS TAILBONE. AFTER A YEAR OF STUDY & PHYSICAL THERAPY A SPINE FUSION WAS DONE. DURING SURGERY 4 PEDICLE SCREWS AND 2 RODS WERE INSTALLED. RPTR HAD A  PREVIOUS FUSION APPROX 14 YEARS EARLIER. THE FALL CRACKED THE FIRST FUSION. PHYSICAL THERAPY & NORMAL DAILY ACTIVITIES CAUSE SEVERE PAIN AND HE WAS AWARDED TOTAL DISABILITIES.
ANESTHESIOLOGIST LET BAR BLOCK SLIP DURING SEIZURES. RESULTS FROM HIS NEGLIGENCE HAVE BEEN SEVERE LACERATION OF TONGUE THAT DAY AND THE FOLLOWING TOOTH PROBLEMS; 4 ROOT CANALS, 6 CROWNS, 2 EXTRACTIONS, 2 IMPLANTS WITH THE POSSIBILITY OF TWO MORE DOWN THE LINE, TMJ SYNDROME, SEVERE MIGRAINE HEADACHES, AND PAIN AND SUFFERING FROM ALL DENTAL PROCEDURES. RPTR ALSO DEVELOPED THRUSH BECAUSE HE HAD TO TAKE ANTIBIOTICS WITH EVERY DENTAL PROCEDURE. HIS DEPRESSION HAS WORSENED SINCE 11/26/93 AS A RESULT OF THE PAIN AND SUFFERING AND HE IS EXPERIENCING SUICIDAL IDEATION TO THIS DAY 1/19/96.
ANESTHESIOLOGIST LET BAR BLOCK SLIP DURING SEIZURES. RESULTS FROM HIS NEGLIGENCE HAVE BEEN SEVERE LACERATION OF TONGUE THAT DAY AND THE FOLLOWING TOOTH PROBLEMS; 4 ROOT CANALS, 6 CROWNS, 2 EXTRACTIONS, 2 IMPLANTS WITH THE POSSIBILITY OF TWO MORE DOWN THE LINE, TMJ SYNDROME, SEVERE MIGRAINE HEADACHES, AND PAIN AND SUFFERING FROM ALL DENTAL PROCEDURES. RPTR ALSO DEVELOPED THRUSH BECAUSE HE HAD TO TAKE ANTIBIOTICS WITH EVERY DENTAL PROCEDURE. HIS DEPRESSION HS WORSENED SINCE 11/26/93 AS A RESULT OF THE PAIN AND SUFFERING AND HE IS EXPERIENCING SUICIDAL IDEATION TO THIS DAY 1/19/96.
DURING INSERTION OF 6.5MM CANNULATED "TITANIUM" SCREW, THE SCREW COMPLETELY SHATTERED AT THE NECK-THREADED JUNCTION. THE SCREW AND PROXIMAL SHAFT WERE SUBSEQUENTLY REMOVED. ATTEMPTS WERE MADE TO REMOVE THE THREAD PART OF THE BROKEN SCREW WITHOUT SUCCESS.
MIDLINE CATHETER 18 GAUGE CUT TO 32 CM PER PROTOCOL VIA LCF, BASILIC VEIN. CATHETER THREADED EASILY WITH GOOD BLOOD RETURN. FLUSHED WITH 0.9% NACL 100CC. PT COMPLAINED OF FLUSHING, LOW BACK PAIN. PT WAS ANXIOUS, TENSE, AND FACE WAS RED. SYMPTOMS LASTED ONLY A FEW MINUTES.
AFTER INSERTING PIC LINE AND WHILE FLUSHING WITH NS PT REACTED. PT'S FACE TURNED BRIGHT RED. HE COMPLAINED OF SHORTNESS OF BREATH, BACK SPASM, AND MID-STERNAL CHEST PAIN. PT WAS PLACED IN TRENDELBERG AND GIVEN OXYGEN. SYMPTOMS SUBSIDED IN 10 MINUTES.
THIS PT HAD AN ADVERSE REACTION DURING THE INITIAL NORMAL SALINE FLUSH AFTER PLACEMENT OF MIDLINE CATHETER. THE REACTION INCLUDED SHORTNESS OF BREATH, FLUSHING, MID-EPIGASTRIC PAIN RADIATING TO BACK, HYPOTENSION, TACHYCARDIA, AND DECREASED OXYGEN SATURATION. PT STABILIZED AFTER 1 HOUR OF TREATMENT INCLUDING OXYGEN, REGLAN, FLUIDS, EKG, AND X-RAYS.
THIS PT HAD A REACTION TO THE CATHETER IMMEDIATELY AFTER IV NURSE THREADED CATHETER. THE REACTION INCLUDED SHORTNESS OF BREATH, FLUSHED FACE, SEVERE BACK PAIN, NAUSEA AND VOMITING, AND HYPOTENSION. PT WAS TREATED WITH OXYGEN AND REGLAN AND STABILIZED AFTER 45 MINUTES.
MRI PROVEN EXTRACAPSULAR RUPTURE OF RIGHT SILICONE GEL BREAST IMPLANT.
PT PERFORMED USUAL LEVEL OF ACTIVITY IN THE MORNING, ATE LUNCH AND LAID DOWN TO REST. UPON AWAKENING, PT WAS IN GREAT PAIN & UNABLE TO WALK. ORTHOPEDIC SURGEON REPORTS THAT PT FRACTURED THE LEFT PROSTHESIS IMPLANTED ON 7/28/95.
THE PT WAS SCHEDULED FOR A REPEAT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WITH INTRACORONARY STENT PLACEMENT ON 6/28/95, FOR RECURRENT ANGINA. DURING THE PROCEDURE, THERE WAS DISLODGEMENT AND RETRIEVAL OF THE PROXIMAL INTRACORONARY STENT PREVIOUSLY IMPLANTED 2/28/95 IN THE RIGHT CORONARY GRAFT WITH OCCLUSION OF THE RIGHT CORONARY GRAFT. ATTENTION WAS DIRECTED TO THE RIGHT CORONARY BYPASS GRAFT. THE 014 GUIDE WIRE WAS PROLAPSED INTO THE DISTAL RIGHT CORONARY WITHOUT DIFFICULTY. 4 MMNON-COMPLIANT BALLOON WAS THEN EASILY ADVANCED INTO THE OSTIUM OF THE RIGHT CORONARY GRAFT AND A SINGLE INFLATION WAS INITIATED. IN THE COURSE OF INFLATION, AT 5 ATMOSPHERES TO 8 ATMOSPHERES IT WAS APPARENT THAT THE BALLOON HAD EXITED THROUGH THE WALL OF THE STENT AND THERE WAS A KINK IN THE BALLOON. THE BALLOON RUPTURED AT THIS LEVEL OF PRESSURE. FOLLOWING THE BALLOON RRUPTURE, ATTEMPTS TO REMOVE THE SYSTEM DID NOT REVEAL GUIDE WIRE MOBILITY AND THE ENTIRE SYSTEM WAS THEN REMOVED EN BLOC. UPON REMOVAL FROM BODY OF THE GUIDE CATHETER BALLOON SYSTEM AND CORONARY GUIDE WIRE THERE APPEARED TO BEQ THE PROXIMAL STENT WITH BALLOON MATERIAL IN ITS INTESTICES ON THE CORONARY GUIDE WIRE.
THIS IS A 57-YEAR-OLD WHITE MALE, DIABETIC, WHO HAD MOST RECENT PENILE PROSTHESIS IMPLANTED 3/94. RECENTLY PT NOTED THAT DEVICE WOULD NO LONGER INFLATE. MALFUNCTIONING OF THE DEVICE WAS CONFIRMED DURING AN OFFICE VISIT WITH UROLOGIST. PT WAS ADMITTED ON 6/22/95 FOR REMOVAL AND REPLACEMENT OF PROSTHESIS. DURING SURGERY, WHILE TRACKING THE TUBING TO THE LEFT CORPORA, IT WAS NOTED THAT IT WAS FRACTURED AT ITS ENTRY TO THE PUMP. THIS PENILE PROSTHESIS WAS REMOVED AND REPLACED WITH AN 18 CM SCROTAL CYLINDER SET WITH PUMP AND CONNECTORS.
PT IS A 48-YEAR-OLD WHITE FEMALE WHO UNDERWENT SILICONE GEL IMPLANTS FOR BREAST AUGMENTATION APPROX 15 YEARS AGO. SHE STATED A RECENT HISTORY OF TRAUMA TO HER LEFT BREAST AREA. SHE WAS SEEN BY THE PHYSICIAN WITH BILATERAL CAPSULAR CONTRACTURE, BUT WITH A MORE SEVERE DEFORMITY ON THE LEFT, WITH THE RIGHT BEING GRADE II AND HER LEFT BEING GRADE III. SHE WAS REFERRED FOR MAMMOGRAPHY TO COMPARE THE RECENT MAMMOGRAMS. THIS WAS REPORTED AS BEING DRAMATICALLY DIFFERENT WITH PROBABLE LEFT INTRACAPSULAR WITH POSSIBLE EXTRACAPSULAR FAILURE. THE PT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL WITH TOTAL CAPSULECTOMIES. SHE WENT TO OR ON 8/31/95 WHERE SHE WAS FOUND TO HAVE AN INTRACAPSULAR FAILURE ON THE RIGHT SILICONE GEL IMPLANT, BILATERAL CAPSULAR CONTRACTURES, AND A SEROMA OF THE LEFT BREAST.
THIS 65-YEAR-OLD MALE HEART TRANSPLANT CANDIDATE WAS ADMITTED ON 9/11/95 WITH ATRIAL FIBRILLATION AND CONGESTIVE HEART FAILURE. PT WAS STARTED ON AMIODORONE FOR CONTROL OF HIS ATRIAL FIBRILLATION WITH PLANS TO CARDIOVERT LATER IN AN ATTEMPT TO RETURN PT TO NORMAL SINUS RHYTHM. PT ORIGINALLY HAD PACEMAKER IMPLANTED IN 3/88, REPORTEDLY FOR SINUS NODE DYSFUNCTION FOLLOWING A MYOCARDIAL INFARCTION. THE PULSE GENERATOR WAS REPLACED ON 9/19/94 WITH A DIFFERENT MODEL PULSE GENERATOR. AT THE TIME OF THE REPLACEMENT, THE VENTRICULAR LEAD IMPEDENCE WAS REPORTEDLY 503 OHMS. SINCE THE PT HAD DEVELOPED ATRIAL FIBRILLATION AND REMAINED IN DDD MODE, THE CARDIOLOGIST REQUESTED THAT PACEMAKER BE EVALUATED AND PROGRAMMED TO VVIR MODE. ON ROUTINE EVALUATION, IT WAS FOUND THAT THE VENTRICULAR LEAD IMPEDANCE IN THE BIPOLAR MODE WAS 189 OHMS, SIGNIFYING FAILURE OF THE POLYEURETHANE INSULATION. IN ADDITION, THIS PARTICULAR LEAD WAS IDENTIFIED AS A MODEL WHICH IS THE SUBJECT OF A SAFETY ADVISORY ALERT DUE TO POOR PERFORMANCE OF THE LEAD. BECAUSE OF THE NEED FOR AMIODORONE AND THE DISTINCT POSSIBILITY THAT THE PT WOULD BECOME PACEMAKER DEPENDENT, IT WAS FELT THAT THE VENTRICULAR LEAD SHOULD BE REPLACED. THE PT WAS TAKEN TO SURGERY ON 9/14/95, AT WHICH TIME THE VENTRICULAR LEAD WAS CAPPED AND REPLACED WITH A NEW PASSIVE FIXATION SILASTIC VENTRICULAR LEAD.
I.V. PUMP TUBING LEAKING AT CLAMP SITE DURING INFUSION. PT SUFFERED NO HARM.
WHILE INSERTING LAPAROSCOPIC TROCAR AT BEGINNING OF LAPAROSCOPIC APPENDECTOMY, VENA CAVA WAS LACERATED. THIS WAS SURGICALLY REPAIRED. POSSIBLE MALFUNCTION OF TROCAR.
PLASMA UNIT SPLIT. IS NOT ON FILE FOR TEXT COPY.  ENTER TEXT.
TAPE WAS USED TO SECURE PLASTIC TUBING USED FOR LABOR EPIDURAL ON PT'S BACK. PT EXPERIENCED SIGNIFICANT CONTACT DERMATITIS WHERE TAPE WAS IN CONTACT WITH SKIN WHICH BLISTERED. RESOLVED AFTER 7-10 DAYS.
PT HAD CRYOTHERAPY TO TREAT ABNORMAL PAP SMEAR. PHYSICIAN WAS USING THIS EQUIPMENT. THE "O" RING AT THE SITE OF THE REMOVABLE TIP WAS BAD AND NITROUS OXIDE LEAKED OUT, CAUSING STINGING SENSATION AND DISCOMFORT. NO ADD'L MEDICAL CARE WAS REQUIRED.
DURING DIALYSIS TREATMENT MACHINE ALARMED. BLOOD OBSERVED IN DIALYSATE.
DURING DIALYSIS TREATMENT MACHINE ALARMED. BLOOD OBSERVED IN DIALYSATE. BLOOD PUMP STOPPED IMMEDIATELY. LINES & PLATES DISCARDED. NEW PLATE  DIALYZER SET-UP & STARTED AGAIN. ALARM SOUNDED. BLOOD OBVIOUS IN DRAIN. 2 MALFUNCTIONS WITH SAME PT. NO INJURY TO PT DUE TO EARLY DETECTION.
NEW PLATE PRIMED AND CONNECTED WITH NO ADD'L PROBLEMS. ARTERIAL PRESSURE GOOD AT 150. NO VIBRATION FROM BLOOD LINES. ARTERIAL PRESSURE THEN WENT TO  400-500. BLOOD LINES START VIBRATING. QUESTIONED IF BLOOD GOING THROUGH DIALYZER PROPERLY. TREATMENT STOPPED AND REPLACED WITH NEW SET UP. NO FURTHER PROBLEMS. NO INJURY, BUT DELAY IN TREATMENT.
DURING DIALYSIS TREATMENT, MACHINE ALARMED, SHOWING BLOOD IN DIALYSATE.
WHEN PRODUCT WAS REMOVED FROM ITS PACKAGING, THE OXYGEN CONCENTRATOR BAG FELL OFF.
MIXING CONTAINER LEAKED INPATIENTS' REFRIGERATOR. ON NEXT MIXING DAY, 2 SEPARATE BAGS LEAKED IN LAMINAR FLOW HOOD, RESULTS IN POSSIBLE CONTAMINATION AND LOSS OF PRODUCT.
PT WAS IN WHEELCHAIR IN WHEELCHAIR ACCESSIBLE BUS. BUS TURNED CORNER. PT'S WEIGHT SHIFTED. WHEELCHAIR CROSSBAR SNAPPED OFF AT JOINT. PT WAS ASSISTED/HELD UP BY STAFF. NO APPARENT INJURIES.
DURING AN OR PROCEDURE A PACKAGE OF X-RAY DETECTABLE SPONGES WAS OPENED AND IT WAS NOTED THAT THE SPONGES WERE MISSING THE BLUE INDICATOR. SPONGES MAY BE MISTAKEN FOR ORDINARY PREP SPONGES. MFR'S QUALITY CONTROL GROUP NOTIFIED BY FAX.
PT CARDIOVERTED X 7 USING MFR'S DEFIBRILLATOR USING MFR'S DEFIBRILLATOR PADS. A REDDENED AREA WAS NOTED AROUND EACH PAD. CARDIOVERSION WAS UNSUCCESSFUL AFTER MULTIPLE ATTEMPTS WITH PAD. AFTER SWITCHING TO PADDLES, CARDIOVERSION WAS SUCCESSFUL.
PT WAS CARDIOVERTED IN PACU USING MFR'S DISPOSABLE DEFIBRILLATOR PADS WITH ADAPTER. AREA REDDENED AND VERY TENDER. CARDIOVERSION WAS UNSUCCESSFUL WITH PADS. AFTER SWITCHING TO PADDLES, CARDIOVERSION WAS SUCCESSFUL.
INTERNAL DEFIBRILLATOR CABLES FOR THE DEFIB/PACER/MONITOR, FAIL TO CHARGE. THIS HAS OCCURRED 8 TIMES SINCE THEY WERE PURCHASED IN EARLY 1995; TWICE LAST YEAR AND 5 TIMES IN THE LAST 3 WEEKS. THIS PROBLEM PUTS THE OPEN-HEART PT AT RISK WHILE A DIFFERENT SET OF PADDLES IS OBTAINED. RPTR HAS DISCUSSED THIS WITH THE COMPANY AND STILL THERE IS NO SOLUTION FOR THE PROBLEM. RPTR HAS FOLLOWED THE RECOMMENDED CLEANING AND MAINTENANCE INSTRUCTIONS.
RPTR WAS TURNING CONTROL KNOB ON GENERATOR & RECEIVED AN ELECTRIC SHOCK. ON 2/2/96, MFR'S SERVICE & SUPPLY COMPANY REPLACED STIMULATOR POTENTIAL BUTTONS, REPLACED WIRE FROM TRANSFORMER BOARD TO ACTIVE JACK, CALIBRATED GENERATOR, & TESTED & REPLACED PT CABLE.
RPTR HAD DELAYED CANCER DETECTION FROM SILICONE BREAST IMPLANTS. SHE HAD 5 CANCEROUS TUMORS RANGING FROM .5 CM TO 2 CM WHICH NEVER SHOWED UP ON REPEATED MAMMOGRAMS. TWO SETS OF MAMMOGRAMS AND A XEROMAMMOGRAM DONE WITHIN 10 DAYS OF EACH OTHER DID NOT REVEAL THE TUMORS. SHE HAS HAD REMOVAL OF HER BREASTS & OVARIES, RADIATION, CHEMOTHERAPY AND A BONE MARROW TRANSPLANT TO SAVE HER LIFE. SHE ALSO HAS ATYPICAL NEUROLOGICAL DISEASE, LUPUS ERYTHEMATOSUS, & LIVER PROBLEMS FROM RESIDUAL SILICONE LEFT IN HER BODY. SHE HAD A SECOND MASTECTOMY 2 YEARS LATER FOR REMOVAL OF RESIDUAL SILICONE AND HAD TO BE PUT ON GAMMAGLOBULIN IV'S EVERY TWO WEEKS BECAUSE HER IMMUNE SYSTEM WAS SO DESTROYED FROM SILICONE. TOTAL MEDICAL COST IN THE LST 5 YEARS IS $368,000. HER MEDICAL DIAGNOSIS CONFIRMED AT THREE MEDICAL SCHOOLS CONCERNING THE DELAYED CANCER DETECTION AND THE SILICONE GEL, TISSUE EXPANDERS AND THE LUPUS AND ATYPICAL NEUROLOGICAL DISEASE. SHE HAS MANY SERIOUS PROBLEMS FROM THE IMPLANTS. SHE HAS DIFFICULTY IN WALKING, SHORT TERM MEMORY LOSS, AND IS 100% DISABLED ON SOCIAL SECURITY MEDICAL DISABILITY. ALL THREE NURSES WHO WORKED IN THE DR'S OFFICE, WHEN SHE WORKED THERE IN 1975 HAD THEIR IMPLANTS RUPTURE AND ALL THREE HAVE SILICONE RELATED DISEASES. (ALSO SEE 1008399,1008400.)
RPTR HAD DELAYED CANCER DETECTION FROM SILICONE BREAST IMPLANTS. SHE HAD 5 CANCEROUS TUMORS RANGING FROM .5 CM TO 2 CM WHICH NEVER SHOWED UP ON REPEATED MAMMOGRAMS. TWO SETS OF MAMMOGRAMS AND A XEROMAMMOGRAM DONE WITHIN 10 DAYS OF EACH OTHER DID NOT REVEAL THE TUMORS. SHE HAS HAD REMOVAL OF HER BREASTS & OVARIES, RADIATION, CHEMOTHERAPY AND A BONE MARROW TRANSPLANT TO SAVE HER LIFE. SHE ALSO HAS ATYPICAL NEUROLOGICAL DISEASE, LUPUS ERYTHEMATOSUS, & LIVER PROBLEMS FROM RESIDUAL SILICONE LEFT IN HER BODY. SHE HAD A SECOND MASTECTOMY 2 YEARS LATER FOR REMOVAL OF RESIDUAL SILICONE AND HAD TO BE PUT ON GAMMAGLOBULIN IV'S EVERY TWO WEEKS BECAUSE HER IMMUNE SYSTEM WAS SO DESTROYED FROM SILICONE. TOTAL MEDICAL COST IN THE LAST 5 YEARS IS $368,000. HER MEDICAL DIAGNOSIS CONFIRMED AT THREE MEDICAL SCHOOLS CONCERNING THE DELAYED CANCER DETECTION AND THE SILICONE GEL, TISSUE EXPANDERS AND THE LUPUS AND ATYPICAL NEUROLOGICAL DISEASE. SHE HAS MANY SERIOUS PROBLEMS FROM THE IMPLANTS. SHE HAS DIFFICULTY IN WALKING, SHORT TERM MEMORY LOSS, AND IS 100% DISABLED ON SOCIAL SECURITY MEDICAL DISABILITY. ALL THREE NURSES WHO WORKED IN THE DR'S OFFICE, WHEN SHE WORKED THERE IN 1975 HAD THEIR IMPLANTS RUPTURE AND ALL THREE HAVE SILICONE RELATED DISEASES. (ALSO SEE 1008398,1008400.)
RPTR HAD DELAYED CANCER DETECTION FROM SILICONE BREAST IMPLANTS. SHE HAD 5 CANCEROUS TUMORS RANGING FROM .5 CM TO 2 CM WHICH NEVER SHOWED UP ON REPEATED MAMMOGRAMS. TWO SETS OF MAMMOGRAMS AND A XEROMAMMOGRAM DONE WITHIN 10 DAYS OF EACH OTHER DID NOT REVEAL THE TUMORS. SHE HAS HAD REMOVAL OF HER BREASTS & OVARIES, RADIATION, CHEMOTHERAPY AND A BONE MARROW TRANSPLANT TO SAVE HER LIFE. SHE ALSO HAS ATYPICAL NEUROLOGICAL DISEASE, LUPUS ERYTHEMATOSUS, & LIVER PROBLEMS FROM RESIDUAL SILICONE LEFT IN HER BODY. SHE HAD A SECOND MASTECTOMY 2 YEARS LATER FOR REMOVAL OF RESIDUAL SILICONE AND HAD TO BE PUT ON GAMMAGLOBULIN IV'S EVERY TWO WEEKS BECAUSE HER IMMUNE SYSTEM WAS SO DESTROYED FROM SILICONE. TOTAL MEDICAL COST IN THE LAST 5 YEARS IS $368,000. HER MEDICAL DIAGNOSIS CONFIRMED AT THREE MEDICAL SCHOOLS CONCERNING THE DELAYED CANCER DETECTION AND THE SILICONE GEL, TISSUE EXPANDERS AND THE LUPUS AND ATYPICAL NEUROLOGICAL DISEASE. SHE HAS MANY SERIOUS PROBLEMS FROM THE IMPLANTS. SHE HAS DIFFICULTY IN WALKING, SHORT TERM MEMORY LOSS, AND IS 100% DISABLED ON SOCIAL SECURITY MEDICAL DISABILITY. ALL THREE NURSES WHO WORKED IN THE DR'S OFFICE, WHEN SHE WORKED THERE IN 1975 HAD THEIR IMPLANTS RUPTURE AND ALL THREE HAVE SILICONE RELATED DISEASES. (ALSO SEE 1008398,1008499.)
ACCORDING TO A CENTER FOR LABORATORY HEALTH STANDARDS AND QUALITY, MFR'S QC POLICY FOR THEIR PORTABLE CLINICAL ANALYZERS IS NOT IN COMPLIANCE WITH CLIA 88 FOR BLOOD GAS ANALYSIS. THE ELECTRIC STIMULATOR DOES NOT MEET THE SPECIALTY QC REQUIREMENT IN SECTION 493.1245 FOR BLOOD GASES. RPTR STATES MFR MUST IMMEDIATELY INFORM ALL CURRENT SYSTEM USERS THAT THEIR QC POLICY DATED 2/9/96 IS IN DIRECT VIOLATION OF CLIA 88 REGULATIONS AND SHOULD SEND OUT A REVISED QC POLICY AS SOON AS POSSIBLE.
FOR A 30-DAY SAMPLING OF RESULTS USING MFR'S BLOOD GAS CARTRIDGE, RPTR EXPERIENCED A 8.75% CARTRIDGE FAILURE RATE. THIS RESULTED IN A REPEAT GAS BEING PERFORMED ON ANOTHER BLOOD GAS ANALYZER. ON 8/22/95, THE MFR'S SYSTEM VERIFICATION PROCEDURE YIELDED SIMILAR RESULTS WITH A 10% CARTRIDGE FAILURE RATE FOR BLOOD GAS ANALYSIS. FROM THESE FINDINGS, RPTR'S FACILITY HAS REMOVED THE SYSTEM FROM THE PT TESTING. RPTR WOULD RECOMMEND FDA INVESTIGATION INTO THE MFG AND QUALITY CONTROL PROCESS OF MFR TO DETERMINE THE ROOT CAUSE OF THIS ALARMING FAILURE RATE.
OPERATOR HAD INCONSISTENT READINGS. OPERATOR FOUND A BAD TEST TUBE IN ONE LOT. TUBE WAS DESIGNED FOR A DIFFERENT TYPE OF TEST OTHER THAN ACTIVATED COAGULATION TIME. MFR SAID THAT VENDOR HAD ONE TEST TUBE GET THROUGH QA THIS WON'T AFFECT ONE MODEL BUT WILL AFFECT OTHER MACHINES. THIS IS A RANDOM CASE.
PT UNDERWENT ABDOMINOPERINEAL RESECTION. SEVERAL DAYS AGO ON THE ATTEMPT TO REMOVE THE PERINEAL DRAIN IT APPARENTLY BROKE IN TWO AND PT HAS A RETAINED FRAGMENT IN THE PERINEAL PRESACRAL SPACE. PT WAS TAKEN TO THE OPERATING ROOM AND MD REMOVED ABOUT 3-4 SKIN STITCHES AND A COUPLE OF CHROMICS AND COULD EASILY PALPATE THE DRAIN AND IT WAS REMOVED. THE PROCEDURE TOOK ABOUT FIVE MINUTES. NO OBVIOUS REASON WHY THE DRAIN BROKE.
PT HAD A FRACTURE OF HIS CATHETER A WEEK OR SO PRIOR TO ADMISSION WITH INFILTRATION OF ADRIAMYCIN INTO THE CHEST WALL. THE PORT-A-CATH WAS REMOVED. THE WOUND WAS BEING TREATED APPROPIATELY WHEN PT WAS ADMITTED WITH SHAKING CHILLS, FEVER, SEPTAL APPEARANCE OF DAY'S DURATION. THIS, ALONG WITH DIZZINESS AND LIGHT HEADEDNESS CAUSED PT TO PASS OUT AND HE WAS BROUGHT TO THE EMERGENCY ROOM. PERTINENT FINDINGS WERE A CLEAR DRAINAGE FROM HIS WOUND SITE, A HARD REDDENED INDURATED AREA OR ORGANOMEGALY AND THE LUNG FIELDS WERE CLEAR. THE PT CONTINUED TO HAVE SPIKING TEMPERATURES. A PERCUTANEOUS DRAIN WAS PUT IN. PT STILL HAD CONTINUOUS SPIKING FEVERS UP TO 102 AND HIGHER AND HE WAS TAKEN TO SURGERY WHERE AN OPEN DEBRIDEMENT OF THIS AREA WAS DONE. MUSCLE BIOPSY SHOWED VIABLE TISSUE.
ON 2/10/93 PT UNDERWENT REMOVAL OF A RUPTURED SILICONE MAMMARY PROSTHESIS (LEFT) AND REPLACEMENT WITH A SALINE-FILLED PROSTHESIS. RECENTLY MRI SHOWED EVIDENCE OF LEAKAGE-THE LEFT IMPLANT WAS CLEARLY DEFLATED. PT UNDERWENT SURGERY ON 9/20/95 FOR REPLACEMENT OF RUPTURED LEFT SALINE BREAST IMPLANT. AT TIME OF SURGERY, THE IMPLANT APPEARED TO BE COMPLETELY INTACT, HOWEVER, IT APPEARED THAT POSSIBLY IT LEAKED THROUGH THE VALVE BUT THERE WAS DEFINITELY NO APPARENT LEAKAGE OR RUPTURE BUT THE IMPLANT WAS COMPLETELY DEFLATED. REPLACEMENT WAS ACCOMPLISHED USING A 200CC SALINE-FILLED MAMMARY PROSTHESIS.
ON 10/8/80 PT HAD BILATERAL SILICONE BREAST IMPLANTS INSERTED. IN 1993 THE LEFT IMPLANT WAS REMOVED DUE TO RUPTURE AND REPLACED WITH A SALINE-FILLED PROSTHESIS. RECENTLY MRI SHOWED EVIDENCE OF LEAKAGE OF THE RIGHT SILICONE IMPLANT-COULD NOT DETERMINE WHETHER IT WAS BLEEDING OR WAS DEFLATED. PT UNDERWENT SURGERY ON 9/20/95. AT TIME OF SURGERY THE IMPLANT APPEARED TO BE BLEEDING. THERE WAS NO FRANK RUPTURE THAT SURGEON COULD DETERMINE AT THE TIME BUT THERE APPEARED TO BE GENERALIZED GROSS BLEEDING. ALL OF THE SILICONE MATERIAL WAS REMOVED FROM THE PT'S CHEST AND THE CHEST SCRUBBED AND COPIOUSLY IRRIGATED.
PT WITH KNOWN LEONARD'S LYMPHOMA HAD A PORT INSERTED ON 2/17/95 WHICH HAD BEEN FUNCTIONING WITHOUT DIFFICULTY. PT HAD BEEN RECEIVING CHEMOTHERAPY AS AN OUTPATIENT UNTIL ADMISSION OF 9/27/95 WHEN PT WAS ADMITTED FOR CONTINUOUS IV INFUSION OF CHEMOTHEREAPY. CHEMOTHERAPY INFUSION OF VP-16, VINCRISTINE AND ADRIAMYCIN, WAS STARTED ON 9/27/95 THRU THE PORT. MEDICATION WAS TO RUN OVER 12 HOURS X 8 DOSES. ON 9/30/95 WHILE RECEIVING CHEMOTHERAPY, PT ACUTELY DEVELOPED RESPIRATORY DISTRESS ACCOMPANIED WITH RIGHT SIDED CHEST PAIN. X-RAY STUDIES SHOWED A LARGE RIGHT PLEURAL EFFUSION WITH COMPLETE COLLAPSE OF THE RIGHT LUNG, WITH CATHETER TIP APPEARING OUTSIDE THE SUPERIOR VENA CAVA. FURTHER STUDIES CONFIRMED POSITION OF DISTAL CATHETER OUTSIDE OF SUPERIOR VENA CAVA. A RIGHT CHEST TUBE WAS INSERTED ON 9/30/95 AND FLUID DRAINED. ON 10/3/95 PT UNDERWENT REMOVAL OF THE RIGHT PORT. IT WAS REMOVED INTACT AND SURGEON COULD IDENTIFY NO PROBLEM WITH THE CATHETER. REASON IT ERODED THRU THE SUPERIOR VENA CAVA IS UNKNOWN. THE PATH REPORT SHOWED A SPECIMEN CONSISTING OF SILVER METAL PLATE WITH AN ATTACHED WHITE PLASTIC TUBING, RESEMBLING PORT AND CATHETER AND MEASURING 3.5 X 3.5 X 1.5 CM. THE PLASTIC TUBING MEASURED 15.0 X 0.4 CM. PT WAS EVENTUALLY DISCHARGED TO HOME, BUT READMITTED AT A LATER DATE WITH UNRELATED SYMPTOMS AND EXPIRED. NO CONCLUSION REACHED IF IT WAS A RESULT OF THE PORT OR PT'S UNDERLYING CONDITIONS.
PT HAD BILATERAL MASTECTOMIES FOR BREAST CANCER IN 1970 AND UNDERWENT BILATERAL BREAST RECONSTRUCTION IN 1981 USING SILICONE MAMMARY PROSTHESIS. IN 1982 THE RIGHT BREAST IMPLANT WAS REPLACED FOR CAPSULAR CONTRACTURE. REPLACEMENT WAS DONE WITH A BILUMENAL PROSTHESIS, HOWEVER THE MFR IS UNKNOWN. RECENT MAMMOGRAM SUGGESTED THAT THE RIGHT IMPLANT WAS DEFLATED. PT DESIRED TO HAVE BOTH IMPLANTS REMOVED AND EXCHANGED FOR SALINE IMPLANTS. PT WAS ADMITTED TO THE HOSP ON 12/12/95 FOR REMOVAL OF SILICONE IMPLANTS. AT TIME OF SURGERY, RIGHT BREAST APPROACHED, CAPSULE IDENTIFIED, CAREFULLY INCISED AND OPENED. THE GEL PART OF THE IMPLANT WAS FOUND TO BE INTACT OF THE BILUMEN IMPLANT. TH SALINE EXTERIOR COATING HAD DEFLATED AND THEN WAS COMPLETELY REMOVED. REPLACEMENT WAS DONE WITH A SALINE-FILLED MAMMARY PROSTHESIS. THE LEFT BREAST WAS THEN APPROACHED. THE CAPSULE IDENTIFIED  AND ENTERED AND IMMEDIATELY UPON ENTERING FREE GEL WAS NOTED. THE IMPLANT WAS COMPLETELY REMOVED ALONG WITH THE GEL. THERE WAS SOME RESIDUAL SILICONE LEFT ON THE CAPSULE SO THEREFORE A COMPLETE CAPSULECTOMY WAS DONE BOTH ON THE ANTERIOR AND POSTERIOR WALL. REPLACEMENT WAS THEN DONE USING A SALINE-FILLED MAMMARY PROSTHESIS.
PT HAD RADIATION IN LEFT HIP AREA DUE TO CARCINOMA THAT LED TO A VASCULAR NECROSIS OF THE LEFT HIP FOR WHICH PT UNDERWENT A TOTAL HIP REPLACEMENT IN 1989. THE PT DID WELL UNTIL 8/95 WHEN A POPPING AND SCRAPING SOUND DEVELOPED IN THE LEFT HIP INDICATIVE OF A DESTROYED POLYETHYLENE LINER REQUIRING REVISION ARTHROPLASTY.
AFTER INDUCTION OF GENERAL ANESTHESIA, VENTILATOR ON ANESTHESIA MACHINE MALFUNCTIONED.
PENILE PROSTHESIS ERODED THROUGH URETHRA.
PT WITH INFLATABLE PROSTHESIS INSERTED 12/20/91. REPLACEMENT WITH ANOTHER MODEL, 18CM WITH A 1CM REAR TIP DUE TO APPARENT MALFUNCTION.
PT WAS BEING TRANSPORTED FROM PT CARE UNIT TO ENDOSCOPY WHEN 02 UNIT FROZE UP CAUSING RESPIRATORY DISTRESS TO PT. PT GIVEN 02 IN ENDOSCOPY UPON ARRIVAL. PT NOW IN MICU ON VENT.
BLOOD NOTED IN THE INTRA-AORTIC BALLOON PUMP DRIVE. LINE RESPIRATORY THERAPIST ATTEMPTED (PER MD) REMOVE CATHETER PER PROTOCOL. MET EXCESSIVE  RESISTANCE. DID NOT ATTEMPT FURTHER. POSSIBLE BALLOON CATHETER MALFUNCTION. BALLOON COULD NOT BE RETRIEVED.
DEFECTIVE PORTS. HAS OCCURRED 3 KNOWN TIMES.
SIMS, SMITHS INDUSTRIES, 1265 GREY FOX RD, ST PAUL, MN 55112. WE HAVE DETERMINED THAT THIS REPORT DOES NOT MEET THE CRITERIA FOR THE MEDICAL DEVICE REPORTING (MDR) REGULATION, 21 CFR.
RPTR STATES THERE WAS LEAKAGE IN THE PUMP SET JUST BELOW BAG SPIKE PROBABLY DUE TO INCOMPLETE ATTACHMENT.
UPPER ROLLER CLAMP NOT CLOSING COMPLETELY. IV SOLUTION RUNNING INTO BURETTE CHAMBER.
PT WAS RECEIVING CHEMOTHERAPY FROM A 500 ML IV BAG ADMINISTERED VIA A VENTED/NONVENTED SET AND PUMP. PT WAS BEING TRANSFERRED FROM STRETCHER TO BED. THE SET TUBING SEPARATED FROM THE PUMP, ALLOWING THE CHEMO SOLUTION TO FREE-FLOW ONTO THE FLOOR. MFR'S REPRESENTATIVES NOTIFIED OF PROBLEM ON 1/30/96. SET IN QUESTION WILL BE HELD FOR EXAMINATION BY MFR UNTIL 3/1/96 AFTER WHICH, IT WILL BE DISCARDED. (*).
PT RANG CALL LIGHT AND SAID "IV IS LEAKING". RPTR ASSESSED SITE, DISCOVERED PIGGYBACK 20 GAUGE 1" NEEDLE WAS ACTUALLY BROKEN IN HALF, REMOVED FROM HUB INTACT. SITE REDRESSED. NO APPARENT PROBLEMS.
MISFIRED. IS NOT ON FILE FOR TEXT COPY.  ENTER TEXT.
THERE IS A POTENTIAL FOR LEAKAGE AND/OR ASPIRATION OF THE MATERNAL MILK BY ELECTRIC PUMP. DIAPHRAGM CAN AND HAS NOT BEEN INSTALLED. ALTHOUGH PUMPING CAN TAKE PLACE, MILK CAN EASILY GO DOWN THE PUMP TUBING. THE DIAPHRAGM SHOULD BE GLUED OR ATTACHED TO THE ADAPTER CAP, AVOIDING THE POSSIBILITY OF IT NOT BEING INSTALLED.
THE INTRA-AORTIC BALLOON COULD NOT BE REMOVED FROM THE ARTERY WITHOUT RISK OF DAMAGE OR DISRUPTION TO THE FEMORAL ARTERY. THERE WAS A FIRM AND IMMOBILE THROMBUS THAT WAS PRESENT IN THE INTRA-AORTIC BALLOON THAT WAS FOUND DURING SURGICAL REMOVAL.
PT HAD ALREADY HAD A TRIPLE LUMEN CATHETER IN RIGHT SUBCLAVIAN AND A DIFFERENT TYPE LINE WAS TO BE INSERTED. LONGER GUIDEWIRE WAS INSERTED. THE MD THEN INTRODUCED THE CATHETER OVER THE GUIDEWIRE. WHEN GUIDEWIRE WAS TO BE REMOVED RESISTANCE WAS FELT AND GUIDEWIRE WOULD NOT COME OUT. X-RAYS REVEALS GUIDEWIRE IS COILED. DEVICE TO BE REMOVED VIA CUTDOWN.
TRIPLE LUMEN CATHETER INSERTED INTO RIGHT SUBCLAVIAN VEIN. A DIFFERENT TYPE CATHETER INSERTED VIA TRIPLE LUMEN CATHETER. IN THE PROCESS OF REMOVING TLC, GUIDEWIRE WENT INTO PT, REQUIRING REMOVAL UNDER FLUOROSCOPY.
WHILE ADVANCING #22 CATHETER INTO PT'S HAND, WHITE PLASTIC CATHETER SEPARATED FROM HUB AND RETRACTED AWAY FROM PT.
CONFUSED ELDERLY PT GOT OUT OF BED WITHOUT ASKING FOR ASSISTANCE. BED ALARM DID NOT SOUND TO ALERT STAFF. PT WAS FOUND ON THE FLOOR, HAVING FALLEN. PT WAS TAKEN TO EMERGENCY DEPT WITH LARGE GASH TO FOREHEAD, BRUISING AND SWELLING TO BOTH KNEES AND TEMPORARY NEUROLOGICAL DEFICITS.
WHEN REMOVAL DRAPES AFTER COMPLETION OF SURGERY, STAFF NOTED A BLACK MELTED SPOT (1/4") ON TOP OF BOVIE PAD, WITH A BLACKENED PINHOLE ON EITHER SIDE. BOVIE PAD CAREFULLY REMOVED. A DIME-SIZED BLISTER NOTED ON PT'S THIGH DIRECTLY UNDER THE BLACKENED AREA OF THE BOVIE PAD.
ON ALERT/RECALL. THE DEVICE IS ON ALERT.
PT HAD TOTAL HIP ARTHROPLASTY 13 YRS AGO. CONSERVATIVE EFFORT FAILED & HAD REVISION OF ACETABULAR COMPONENTS WITH TOTAL HIP 1 MO AGO. PT NOW HAS DISLOCATED HIP WITH THE METAL MARKER AT 6 O'CLOCK RATHER THAN 12 O'CLOCK. APPEARS METAL MARKER RIMMING THE POLYETHYLENE IS DEPLACED BEYOND THE CONFINES OF THE ACETABULAR DOME.
PT INVOLVED IN MOTORCYCLE VS. AUTO ACCIDENT 12/94. PT CRITICALLY INJURED. PLATE IN TIBIA PLACED SEVERAL DAYS AFTER ACCIDENT. PT HAS PERSISTENT PAIN IN PROXIMAL TIBIA. HARDWARE REMOVED 8/1/95 AND REAMED, LOCKED NAILING USED. ONE SCREW HAD FRACTURED-UNKNOWN TIME.
IMPLANT INSERTED IN 1991. IN 9/95 DEVICE STOPPED INFLATING. ON 10/31/95 IMPLANT REMOVED. THERE WAS AN APPARENT PIN HOLE LEAK AT THE JUNCTION OF THE DISTAL THIRD AND THE MIDDLE THIRD. NEW DEVICE IMPLANTED.
PT HAD TOTAL KNEE REPLACEMENT SURGERY 6/88. NOW RETURNS DUE TO PAIN AND DECREASED MOBILITY. PATELLAR COMPONENT SETTLED AND LOOSENED FROM BONY ATTACHMENT.
THIRD PROCEDURE 6/23/94-PLACEMENT OF RODS, SCREWS, HOOKS, AND ALLOGRAFTS. PT RETURNED DUE TO FRACTURE OF ROD. DURING PROCEDURE NO EVIDENCE OF PSEUDOARTHROSES. SOLID FUSION OF THORAX SACRUM.
SET HAD HOLE IN TUBING WHEN TRYING TO FLUSH SALINE. NO INJURY TO PT. PRODUCT WAS RETURNED TO MFR; RESPONDED 8/16/95, WILL EVALUATE.
DORSAL NERVE STIMULATOR DID NOT STIMULATE PT DURING TESTING. PHYSICIAN TRIED TO TEST PT IN DIFFERENT WAYS BUT PT COULD NOT FEEL ANYTHING. NO INJURY TO PT. (DEN 1006790)
CONNECTING PIECE ON TUBING BROKE IN PACKAGE. NO PT INVOLVEMENT/INJURY. MFR RESPONDED ON 11/15/95; MFR IS MAKING STRIDES TO MAKE COMPONENTS IN PACKAGE STRONGER. (DEN 1006889)
CLIP WAS GIVEN TO TECH ON STERILE FIELD, TECH PROCEEDED TO TEST FIRE THE INSTRUMENT, AND WENT TO ROTICULATE IT, THEN DEVICE JAMMED. THE INSTRUMENT WOULD NOT FIRE OR ROTICULATE. NO PT INJURY. (DEN 1007941).
SPONGE FRAGMENTED IN WOUND. NO PT INJURY.
HIP PROSTHESIS APPARENTLY FAILED AFTER 10 YEARS AND NEEDED TO BE REPLACED.
PT WAS DISCHARGED FROM HOSPITAL AND BEING TRANSPORTED BY AMBULANCE TO HOME. HOSPITAL WHEELCHAIR WAS REMOVED FROM FACILITY AND PLACED IN AMBULANCE TO TRANSPORT PT TO APARTMENT FROM AMBULANCE. WHILE PLACING PT IN THE WHEELCHAIR AT HER RESIDENCE, WHEELCHAIR APPARENTLY BEGAN TO BEND AND COLLAPSE UNDER THE HEAVY WEIGHT OF THE PT. THE PT WAS TRANSPORTED BACK TO THE HOSP AND READMITTED. THE PT'S FALL WAS CONTROLLED AS MUCH AS POSSIBLE. THE PT'S WOUND WAS REOPENED.
PHYSICIAN SENT A FEMALE PT FOR OPEN MRI, TO RULE OUT MALIGNANCY IN ARMPIT. OPEN MRI DID NOT DETECT ANY. A FEW MONTHS LATER PT CAME BACK, BECAME MUCH WORSE AND A REGULAR MRI DETECTED A MALIGNANCY. PHYSICIAN SENT ANOTHER PT FOR OPEN MRI OF BACK. IT DETECTED A BENIGN TUMOR (NEUROFIBROMA) IN THE VERTEBRAL COLUMN. PT WAS SCHEDULED FOR SURGERY WHEN A REGULAR MRI WAS DONE. THE REGULAR MRI DETECTED THAT A SPUR OF A DISC WAS COMPRESSING ONE NERVE (CAUSING THE PAIN) WHICH THE OPEN MRI MISSED. THE PHYSICIAN REALLY QUESTIONS THE EFFECTIVENESS OF THIS DEVICE. BOTH INSTANCES STRIKE RPTR AS BEING ON THE VERGE OF MALPRACTICE. HE IS VERY CONCERNED. HE BELIEVES THAT THERE IS ROOM FOR THE OPEN MRI TO DO CHILDREN AND THE OVERWEIGHT, BUT RIGHT NOW THESE FACILITIES ARE ADVERTISING THEMSELVES AS BEING ABLE TO DO EVERYONE, AND RPTR THINKS THAT THIS IS INAPPROPRIATE SINCE THE IMAGES THEY PRODUCE ARE VERY POOR.
DURING SURGERY (TAH), ARM BOARD FELL OFF WITH PT'S ARM ON IT. ARM HAD BEEN ON BOARD APPROXIMATELY 1 HR. PT MORBIDLY OBESE (350 POUNDS). NO HARM TO PT. MFR OF BOARD CONTACTED.
DURING ARTERIOR CORPECTOMY T12 & L1 SCREW HEADS BROKE OFF OF SCREWS.
PT RECEIVED DEFIBRILLATOR DISCHARGE (SHOCK). SUBSEQUENTLY HE NOTED A BEEP EMITTED BY THE DEVICE EVERY MINUTE. USUAL END-OF-LIFE BEHAVIOR IS A BEEP EVERY 6 HRS. OFFICE INTERROGATION REVEALED AN ERROR MESSAGE AS WELL AS INAPPROPRIATE BATTERY DEPLETION. THE GENERATOR WAS FELT TO BE DEFECTIVE BY MFR'S TECHNICAL SERVICE REPRESENTATIVES. THEY RECOMMENDED GENERATOR EXCHANGE. THIS WAS PERFORMED ON 7/21/95.
REPORTER PURCHASED ABOUT 50 CHAIRS FROM THE COMPANY OVER A PERIOD OF 8 MONTHS. INITIALLY, REPORTER HAD PROBLEMS WITH THE CHAIRS. HE CONTACTED THE MFR, AND MFR SAID THAT THEY WERE THE ONLY ONES WHO HAD THIS PROBLEM AND IT WAS THE REPORTER'S EMPLOYEES WHO WERE SETTING UP THE CHAIRS INCORRECTLY. THEREFORE, RPTR HIRED AN OUTSIDE COMPANY TO SET THE CHAIRS UP. REPORTER STILL HAD A PROBLEM WITH THE REAR DRIVE WHEEL ON THE LEFT SIDE. IT CAME OUT OF THE UNIT DURING USE. ABOUT 30% OF THE CHAIRS WERE REPLACED BUT REPLACEMENTS HAD THE SAME PROBLEMS. IN ADDITION, CHAIRS WERE MISSING PARTS. THERE IS POOR QUALITY CONTROL. MANY GEAR BOXES WENT OUT AND DID NOT WORK THE FIRST TIME OF USE. MFR SAID THAT THEY WOULD FIX THE PROBLEM BUT CONTINUED TO SHIP THE SAME DEVICE. THE COMPANY'S PRESIDENT TOOK PHONE CALLS PERSONALLY AND SAID IT WAS THE RETAILER'S PROBLEM. THREE PTS WERE INJURED. ONE HAD A DISLOCATED FINGER AND DAMAGE TO HER LEG. THE SECOND SUFFERED INJURIES WHEN THE WHEEL CAME OFF WHILE THE PERSON WAS CROSSING THE STREET.
LOCAL DISTRICT ATTORNEY AND MEDICAL EXAMINER OFFICE REQUEST THAT CO CEASE INVESTIGATION UNTIL LOCAL LAW ENFORCEMENT COMPLETES ITS INVESTIGATION.
MASK APPEARS IN AVERAGE CONDITION, WITH A YELLOW AIR TUBE AND MARKED AND CRAZED CONNECTOR. THE RUBBER OF THE AIRWAY TUBE IS SMOOTH TO THE TOUCH AND LACKING IN ITS USUAL RESISTANCE. ON ATTEMPTING TO BEND THE TUBE THROUGH 180 DEGREES, THE TUBE KINKED BETWEEN 45 AND 90 DEGREES. THE PRINTING ON THE AIRWAY TUBE IS BEGINNING TO FADE. IT IS REPORTED BY THE HOSP THAT THIS MASK HAD BEEN USED AT LEAST 200 TIMES. THE AIRWAY TUBE HAS BROKEN BETWEEN 40 AND 55MM FROM THE BACKPLATE. THE FAILURE SURFACE IS AT 45 DEGREES TO THE AXIS OF THE TUBE. THE AREA OF THE FAILURE SURFACE NEAREST THE BACKPLATE IS CLOSE TO THE OUTER EDGE OF THE TUBE, THE CRACK RUNS FROM 60MM FROM THE CONNECTOR FOR A LENGTH OF 38MM. THE CRACK IS AROUND THE OUTER EDGE OF THE TUBE, CLOSE TO THE BLACK LINE. THE CRACK HAS PENETRATED THROUGH THE MATERIAL. MOST OF THE CRACK IS STRAIGHT, BUT THE LAST 5-10MM ON BOTH ENDS IS RAGGED. AT 46MM FROM THE CONNECTOR, THERE IS A DEEP SCRATCH IN THE RUBBER, 5MM LONG AND PERPENDICULAR TO THE AXIS OF THE TUBE. WITHOUT A GREAT DEAL OF FURTHER INFO REGARDING THE HISTORY OF THIS MASK, IT IS DIFFICULT TO PROVIDE AN ACCURATE EXPLANATION OF THE FAILURE. HOWEVER, MOST LIKELY CAUSE OF FAILURE IS THAT AT SOME STAGE, PRIOR TO THE OPERATION IN WHICH FAILURE OCCURRED, THE AIRWAY TUBE HAD BEEN FLATTENED SUFFICIENTLY TO CAUSE THE RUBBER TO CRACK IN TWO PLACES. THE FORCE REQUIRED TO CAUSE THE CRACKS BEING LESSENED BY THE EXCESSIVE USE OF THE MASK.
DR DOES NOT ROUTINELY USE A BITE BLOCK AND PERFORM THE PRE-USE PERFORMANCE TESTS BEFORE EACH REUSE OF THE DEVICE. THIS IS CONTRARY TO THE DIRECTIONS FOR USE IN THE INSTRUCTION MANUAL FOR THIS DEVICE. ADD'L INFO OBTAINED BY THE U.S. DISTRIBUTOR FROM DR. INDICATES THAT THERE WERE NO COMPLICATIONS OR ADVERSE EVENTS NOTED. THE EVENT INVOLVED A 38 YEAR OLD, 178 LB. MALE. ANOTHER DEVICE USED WITH THIS PT WITHOUT EVENT AND THE PROCEDURE PROCEEDED WITHOUT PROBLEMS. MASK APPEARS IN AVERAGE CONDITION, WITH A YELLOW AIRWAY TUBE AND MARQKED CONNECTOR. THE CONNECTOR IS HEAVILY CRAZED. THE AIRWAY TUBE HAS BROKEN 3-7MM FROM THE BACKPLATE. THE FAILURE SURFACE IS PERPENDICULAR TO THE AXIS OF THE TUBE. THE FAILURE SURFACE IS SMOOTH WITH NO OBVIOUS DEFECTS. THE SURFACE APPEARS TO BE SYMMETRICAL AND IS IN TWO "SIDES" THAT JOIN IN A THIRD AREA FARTHEST AWAY FROM THE BLACK LINE. THERE IS NO SECONDARY CRACKING PRESENT. THERE IS A NUMBER OF LIGHT "SCORE" MARKS ALONG THE LENGTH OF THE BLACK LINE. WITHOUT FURTHER DETAILED INFO REGARDING THE PRIOR HISTORY OF THIS MASK, IT IS DIFFICULT TO GIVE AN EXACT EXPLANATION FOR THIS FAILURE. PRIOR EXPERIENCE HAS SHOWN THAT IN CERTAIN CIRCUMSTANCES THE DEVICE CAN BE BITTEN IF A BITEBLOCK IS NOT USED.
RIGHT SUBCLAVIAN TLC INSERTION. PT PREPPED AND DRAPED IN USUAL STERILE FASHION. RIGHT SUBCLAVIAN VEIN CANNULATED; GUIDEWIRE INSERTED BUT DID NOT  ADVANCE WELL. REMOVED WITH SOME RESISTANCE. DID NOT APPEAR TOTALLY INTACT.  CHEST X-RAY REVEALS 1CM METAL WIRE IN RIGHT SUBCLAVIAN VEIN REGION.
CATHETER INSERTED PER PHYSICIAN IN RIGHT JUGULAR VEIN. PT BECAME UNSTABLE. AFTER INTRAOPERATIVE XRAY, CATHETER REMOVED. CHEST TUBE PLACED RIGHT CHEST. INTRAOPERATIVE CPR INITIATED. MEDIAN STERNOTOMY PERFORMED. SMALL RENT IN SUPERIOR VENA CAVA AT JUNCTION OFAT RIGHT SUBCLAVIAN VEIN & RIGHT INTERNAL JUGULAR VEIN. SUTURE REPAIR OF SUPERIOR VENA CAVA LACERATION. DISCHARGED TO HOME.
RHYTHM CHANGE TO VENTRICULAR TACHYCARDIA NOTED AT CENTRAL STATION. MONITOR DID NOT ALARM AUTOMATICALLY, RUN GRAPH; ALARM DELAY NOTED ON GRAPH STRIP WHEN INITIATED MANUALLY.
DURING PHACOEMULSIFICATION STAGE OF CATARACT EXTRACTION, PT SUSTAINED A 3X4MM BURN TO CORNEA; CONVERTED TO EXTRACTION CAPSULAR LENS EXTRACTION WITH IMPLANTATION OF ANTERIOR CHAMBER LENS.
DURING HIP FRACTURE REPAIR, THE STAINLESS STEEL SCREW TIP OF YANKAUER  SUCTION WAS NOTED TO BE MISSING; SEARCH FOR THE TIP PRIOR TO SURGERY COMPLETION WAS UNSUCCESSFUL; POST-OPERATIVE FILM SHOWED THE TIP IN THE FEMUR SHAFT; NO ADVERSE OUTCOME TO DATE.
CANNULA SHEARED UPON ENTERING SKIN. NO INJURY TO PT.
A VASCULAR PROSTHESIS IN A PT WAS REPLACED BECAUSE THE IMPLANT SITE HAD BECOME INFECTED. ACCORDING TO THE TRANSPLANT PHYSICIAN, THE IMPLANT WAS WEEPING SERUM WHICH COLLECTED AT THE IMPLANT SITE. THE PHYSICIAN BELIEVES THIS MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION.
DURING A PROCEDURE TO REMOVE EXCESS FLUID FROM A PT'S PERICARDIUM, A SURGICAL TROCAR BROKE INTO SEVERAL PIECES. MOST OF THE BROKEN TROCAR WAS REMOVED, BUT ONE OR TWO SMALL (3MM OR LESS) PIECES MAY REMAIN IN THE PT'S SUBCUTANEOUS TISSUE. BECAUSE THE PT WAS VERY OBESE, AND THE LENGTH OF A THORACIC TROCAR WAS UNSATISFACTORY, IT WAS NECESSARY TO USE AN ABDOMINAL TROCAR. THE MFR AGREES THAT THERE WAS NO OTHER OPTION FOR THE SURGEON. A POSSIBLE EXPLANATION FOR THE BREAKAGE WAS CONTACT WITH THE RIBS OR TORQUING DURING THE PROCEDURE. THE SURGEON DID NOT THINK THE DEVICE WAS TORQUED, BUT BECAUSE IT WAS PLACED BETWEEN THE RIBS AND A RIGID SCOPE WAS USED, IT IS POSSIBLE THAT MOVEMENT OR TORQUING OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PT APPARENTLY SUFFERED NO ILL EFFECTS, HOWEVER, INFECTION AND PAIN WERE CITED AS POSSIBLE COMPLICATIONS. THE DEVICE WILL BE RETURNED  TO THE MFR FOR ANALYSIS OF THE FAILURE.
FOLLOWING A CAROTID ENDARECTOMY, A FABRIC PATCH WAS USED TO CLOSE THE INCISION IN A PT'S CAROTID ARTERY. EXCESSIVE BLEEDING OCCURRED AT THE CLOSURE SITE. THE SURGEON HAD PROPERLY PREPARED THE MATERIAL BY PRE WETTING. MD NOTED THAT DURING STITCHING, THE FABRIC FELT "FUNNY". AS A RESULT OF THE BLEEDING, THE PT EXPERIENCED SOME BLOOD LOSS, CHANGES IN ECG AND A DECREASE IN HEMATOCRIT. THE PT WAS TREATED WITH TOPICAL HEMOSTATIC AGENTS AND GIVEN A BLOOD TRANSFUSION. THE INCIDENT ADDED 90 MINUTES TO THE LENGTH OF THE PROCEDURE. THE PT HAS SINCE RECOVERED, WAS DISCHARGED AND IS NOT EXPECTED TO EXPERIENCE ANY COMPLICATIONS FROM THE EVENT. ALL SAMPLES OF THE PATCH WITH THE SAME LOT NUMBER WERE REMOVED FROM THE OR STOCKROOM.
PT WAS ADMITTED TO OR FOR REPLACEMENT OF TIBIAL PLATE. THE ORIGINAL INSERTION DATE WAS 1/24/95, BETWEEN THAT DATE AND CURRENT SURGERY DATE, 8/1/95, THE PLATE WAS BROKEN. THE PT WAS IN A CAST WHEN DISCHARGED FOLLOWING FIRST HOSPITALIZATION.
DURING SURGERY 8/31/95, IT WAS FOUND THAT THE INCORRECT COMPONENT WAS INSERTED DURING FIRST SURGERY; A CEMENTED INSERT RATHER THEN NON-CEMENTED COMPONENT.
DURING CODE, RESUSCITATOR WOULD NOT WORK. MOUTH TO TUBE RESUSCITATION PERFORMED WHILE SECOND BAG ATTACHED. ALL BAGS WITH LOT # REMOVED FROM SERVICE.
DURING CYSTOSCOPY PROCEDURE, UPON INFLATING URETERAL DILATION BALLOON CATHETER TO 12 ATMOSPHERES IN FOUR MINUTES, THE BALLOON RUPTURED CAUSING URETERAL DAMAGE.
PT FOUND ON FLOOR OF ROOM. PT HAD FALLEN. APPARENTLY, DURING FALL, RIGHT CENTRAL LINE SNAPPED OR SHEARED OFF. APPROX 3/4 INCH OF LINE WAS VISIBLE; THE REST OF THE LINE REMAINED IN THE PT. X-RAY WAS TAKEN AND UNDER FLUOROSCOPIC GUIDANCE VIA VEIN PUNCTURE PERCUTANEOUS REMOVAL OF REMAINING CATHETER PIECE WAS ACCOMPLISHED.
CHILD WAS SITTING IN BED. OECO HOSE AND CARDENS VALVE WAS CONNECTED TO TRACH. CHILD WAS OBSERVED HOLDING CARDENS VALVE. THE CLEAR HUB OF HIS TRACH WAS CONNECTED TO THE TRACH. THE CHILD STARTED COUGHING AND "BLEW" THE CLEAR NOSE PORTION OF HIS TRACH OFF THE BLUE PORTION OF THE TRACH. THE BLUS PORTION CONTINUED TO BE INSERTED INTO THE CHILD'S TRACH. REQUIRED INSERTION OF NEW STERILE TRACH. AGE OF DEVICE: 15 DAYS.
CHILD WAS SITTING AT THE TABLE EATING LUNCH. SPEAKING VALVE WAS CONNECTED TO THE TRACH. THE CHILD STARTED COUGHING AND "BLEW" THE CLEAR NOSE PORTION OF THE TRACH OFF THE BLUE PORTION OF THE TRACH. THE BLUE PORTION CONTINUED TO BE INSERTED INTO THE CHILD'S TRACH. REQUIRED INSERTION OF A NEW STERILE TRACH. AGE OF DEVICE: 12 DAYS.
NEW GASTROSTOMY BUTTON INSERTED BY THE PHYSICIAN. CHILD WAS HOME FOR SCHOOL BREAK. UPON RETURN TO SCHOOL ON 8/28/95, MOTHER NOTIFIED THE NURSES THAT THE BUTTON BROKE ON 8/17/95. NOTED A TEAR HALF WAY THRU THE TOP SHAFT OF THE BUTTON DEVICE. REQUIRED INSERTION OF A NEW BUTTON. AGE OF DEVICE: 5 DAYS.
ON 10/13/95 MOTHER REPORTED TO NURSES THE EVENING BEFORE SHE NOTED THE GASTRO TUBE WAS LEAKING NEAR THE SHAFT OF THE BUTTON. A SLIT AT THE TOP OF THE SHAFT WAS NOTED. REQUIRED INSERTION OF A NEW GASTROSTOMY BUTTON. AGE OF DEVICE: 23 DAYS.
ON 10/13/95 AT 3:00 A.M., NOTED A REDDENED AREA ON CHILD'S SKIN [RIGHT SIDE, BOTTOM OF RIB CAGE] MEASURING APPROX 1-1/2" LONG BY 1/2" WIDE. ONE AND ONE HALF HOURS LATER, THE NURSES NOTED HEATED AEROSOL TUBING HAD APPROX AN AREA 6" IN LENGTH WHERE PLASTIC HAD MELTED. APPROXIMATE AGE OF DEVICE: 1 DAY.
GASTROSTOMY BUTTON WAS NOTED TO HAVE A CRACK AT THE TOP OF THE SHAFT. REQUIRED INSERTION OF A NEW BUTTON. AGE OF DEVICE: 17 DAYS.
ON 12/7/95 AT 5 A.M. HIGH TEMP ALARM SOUNDED. UPON CHECKING THE TUBING, THE NURSE NOTED THE TUBING FELT WARMER THAN USUAL. FOUND AN AREA APPROX 8" IN LENGTH ON TUBING WHERE WIRES BEGAN TO MELT THE PLASTIC. NO INJURY NOTED TO CHILD. NO BEDDING RESTING ON TUBING. TUBING NOT RESTING IN CHILD EITHER. APPROX AGE OF DEVICE: 3 DAYS. TUBING REPLACED.
ON 12/30/95 AT 4:30 P.M., VENT TUBING WAS NOTED TO BE MELTED. AREA 1-1/2 INCHES IN LENGTH ON WHITE TUBING, APPROX 1 1/2 FEET AWAY FROM THE CHILD WAS NOTED TO BE MELTED. AREA 2 INCHES IN LENGTH ON BLUE TUBING, APPROX 8 INCHES FROM THE CHILD WAS ALSO NOTED TO BE MELTED. APPROX 5 MINUTES PRIOR, THE  HEAT SETTING WAS 34 DEGREES. AT THE TIME MELTED AREAS ON TUBING WAS NOTED-TEMPERATURE READING WAS 34.1 DEGREES. SEVERAL MINUTES LATER THE HEAT TEMPERATURE WAS 35 DEGREES. APPROX AGE OF DEVICE 2 DAYS. NEW CIRCUIT APPLIED.
VITAL SIGNS MONITOR FELL DOWN ON A PT'S FACE. ACCIDENT HAPPENED BECAUSE OF THE OPERATOR MISPLACED MONITOR HOLDING SLOT WHICH WAS ON THE BACK SIDE OF THE MONITOR.
RPTR'S FACILITY HAS RECEIVED SEVERAL COMPLAINTS ABOUT THE QUALITY OF MFR'S CONDOMS. PUBLIC HEALTH AND EMERGENCY ROOM HAVE RECEIVED ABOUT 45 COMPLAINTS COLLECTIVELY. THE CONDOMS BREAK EASILY DURING USE AND ARE NOT FITTING PROPERLY (TOO SMALL). PUBLIC HEALTH STATED THAT THESE CONDOMS ARE UNFIT FOR THEIR INTENDED USE. RPTR REQUESTS THAT THESE CONDOMS BE REMOVED FROM GOVERNMENT INVENTORY. RPTR HAS SUSPENDED AND REMOVED ALL STOCK FOR ISSUE AND USE.
THE HUBS ARE CRACKING AND/OR BREAKING, WHICH CAUSES LEAKAGE WHEN THE PRODUCT IS USED.
TWO PREPERITONEAL BALLOONS BURST INSIDE PT WHILE BEING INSUFFLATED, REQUIRING EXPLORATION TO REMOVE FRAGMENTS.
SPECS STATE 36" MIN AND 48" MAX HEIGHT. CRUTCHES SUPPLIED BY COMPANY ONLY GO TO 42" WHICH IS TOO SHORT. ANYONE BETWEEN 5'2" OR 5'3" AND 5'6" CANNOT USE THESE CRUTCHES. THE CRUTCHES ARE PRE-ASSEMBLED, THEN VARNISHED MAKING IT HARDER TO RE-ASSEMBLE THEM. THEY TEND TO SPLINTER OR CRACK WHEN THE HANDGRIP IS LOWERED TO THE THIRD OR FOURTH POSITION. THE CORNERS OF THE EXTENSIONS ARE VERY SHARP AND IRRITATE OR SCRAPE PT'S HANDS WHEN USING THE CRUTCHES.
PT WITH SINGLE LUMEN CATHETER TESTED POSITIVE FOR COAG NEGATIVE STAPH. CATHETER REMOVED. THIS CATHETER WAS INSERTED IN 5/95, AND WAS REPORTED TO HAVE LOOSE CONNECTIONS.
THE DESIGN OF THIS PRODUCT IS INFERIOR. THE UNIT NEVER REMAINS IN PLACE, IE THE PRONGS COME OUT OF THE NARES. OXYGEN DELIVERY TO THE PT IS THUS COMPROMISED.
PT WITH PERMANENT RIGHT ATRIAL CATHETER PLACED 5/5/95. CATHETER NOTED TO HAVE LOOSE CONNECTIONS. ON 6/21/95 CATH-REMOVED WHEN BLOOD CULTURE POSITIVE FOR ACINETOBACTER CALCOACETICUS (GRAM NEGATIVE ROD).
NO VACUUM WAS PRESENT INSIDE THE ACTUAL URINE DRAINAGE BAG, MAKING IT NECESSARY TO MANUALLY OPEN THE VALVE ON THE BAG IN ORDER TO FACILITATE DRAINAGE OF THE BLADDER WHICH WOULD TYPICALLY SIGNAL GOOD PLACEMENT OF THE URINARY CATHETER.
PT WITH 9 FRENCH DOUBLE LUMEN CATHETER CULTURED POSITIVE FOR COAG. NEGATIVE STAPH. THIS LINE HAS BEEN INSERTED 3/20/95. IT WAS NOTED TO HAVE LOOSE CONNECTIONS.
PT WITH 7 FRENCH DOUBLE LUMEN CATHETER CULTURED POSITIVE FOR COAG. NEGATIVE STAPH ON 2/28/95. THE LINE WAS REPAIRED AND EVENTUALLY REMOVED 4/24/95 WHEN POSITIVE FOR KLEBSIELLA PNEUMONIA. THE PT NOW HAS A PORT AND CATHETER. THE PT'S CATHETER WAS NOTED TO HAVE LOOSE CONNECTIONS, WITH THE SYRINGE FALLING OUT.
A NEEDLE ON ONE SYRINGE WAS NOT BEVELED (POINTED). SOME OF THE RUBBER STOPPERS INSIDE THE SYRINGES ARE FLAT, WHILE THE MAJORITY OF THEM ARE POINTED. THE PATIENT COULD NOT USE THE SYRINGE THAT WAS NOT BEVELED BECAUSE OF THE ADDED UNDUE PAIN AND WAS NOT SURE WHERE TO MEASURE THE INSULIN DUE TO THE INCONSISTENCY OF THE RUBBER STOPPERS.
PT WITH 7 FRENCH DOUBLE LUMEN CATHETER DEVELOPED DIFFICULTY WITH LOOSE CONNECTIONS. LINE WAS REPAIRED DUE TO LOOSE CONNECTION. THE LINE WAS CULTURED AND FOUND TO BE POSITIVE FOR KLEBSIELLA AND PSEUDOMONAS.
LASER OVERHEATED SURROUNDING INSTRUMENT, CAUSING LIP BURN. ON FOLLOW UP EXAM OF LASER FIBER HANDPIECE, FIBER WAS NOTED TO BE PROTRUDING FROM HANDPIECE TIP, CAUSING UNEVEN HEAT TRANSFER.
STAFF BELIEVED THEY WERE UTILIZING PROCESSED HUMAN TISSUE. IT IS NOW BELIEVED THAT THERE WAS NO TISSUE. IT IS NOW BELIEVED THAT THERE WAS NO TISSUE IN THE CONTAINER AND THAT GAUZE WAS IMPLANTED.
THE MFR OF THE DEVICE IS: COOK PACEMAKER CORP. PO BOX 529, LEECHBURG PA 15656.
STAFF BELIEVED THEY WERE UTILIZING PROCESSED HUMAN TISSUE. IT IS NOW BELIEVED THAT THERE WAS NO TISSUE IN THE CONTAINER AND THAT GAUZE WAS IMPLANTED.
OVER THE PAST FEW MONTHS RPTR HAS RECEIVED A GOOD NUMBER OF THESE GLOVES WITH THE END OF THE BOX OPEN AND THE GLOVES FALLING OUT.
PT HAD PORT INSERTED 6/9/95. ON 6/13/95, PT RECEIVED FIRST DOSE OF CORBOPLAT THROUGH PORT. PT EXPERIENCED SEVERE PAIN. CHEST X-RAY WITH DYE INSERTION INTO THE PORT FOUND THE CATH IN THE RIGHT ATRIUM. CATHETER WAS FREE FROM FITTING. IT WAS RETRIEVED THROUGH THE RIGHT GROIN.
ARROW INTL, 3000 BERNVILLE RD, READING, PA 19605. AS I EXPLAINED DURING OUR TELEPHONE CONVERSATION, WE WERE UNABLE TO FIND THIS REPORT IN OUR DATABASE, AND BASED UPON THE LIMITED INFO THAT YOU PROVIDED, WE ARE UNABLE TO RESPOND TO YOUR QUESTIONS.
UPON OPENING BOXES OF THESE GLOVES RPTR DISCOVERED THAT A NUMBER OF GLOVES CONTAINED SEVERE DRY ROT. RPTR INSPECTED ALL STOCK ON HAND AND FOUND 9 BOXES ON HAND. ALL BOXES WERE IMMEDIATELY SUSPENDED. THE DRY ROT WAS SUBSTANTIAL. IN ONE CASE, THE GLOVES HAD PRACTICALLY DISINTEGRATED.
MATERIAL TEARS EASILY DURING DONNING PROCEDURE. ITEM NOT ACCEPTABLE FOR DENTAL PROCEDURES. PREVIOUS BRANDS ARE WITHIN ACCEPTABLE LIMITS.
RPTR TRIED ON FOUR PAIRS OF GLOVES TODAY. THE FIRST THREE PAIRS RIPPED WHILE BEING PUT ON. THE FOURTH PAIR HAD A HOLE IN IT LARGE ENOUGH TO PUT RPTR'S FINGER THROUGH. THESE GLOVES ARE UNACCEPTABLE FOR USE IN ORAL SURGERY WHERE THEY CAN BE EASILY RIPPED.
PT HAD INFLATABLE PROSTHESIS INSERTED IN 7/91. DURING COITUS PT EXPERIENCED DEFLATION AND PUMP FAILURE. SURGICAL REMOVAL OF PUMP ON 12/6/95 REVEALED COMPLETE RUPTURE OF TUBING LEADING TO RIGHT PENILE CYLINDER. THE TUBING LEADING TO RIGHT PENILE CYLINDER HAD DISRUPTED AND SHEARED APPROX 1CM FROM ITS INSERTION INTO PUMP.
DRAIN IN (L) BREAST WAS TO BE REMOVED. FIVE TO SIX INCHES OF THE DRAIN REMAINED IN BREAST. PT RETURNED TO OR TO REMOVE RETAINED DRAIN.
DURING SURGICAL PROCEDURE (URETEROSCOPY) A STONE BASKET, WHICH WAS INSERTED INTO THE URETER, BROKE AT THE CONNECTION OF THE BASKET AND SHAFT, AND THE BASKET WAS RETAINED IN THE URETER WHEN THE SHAFT WAS REMOVED. THE BASKET WAS PUSHED INTO THE KIDNEY WITH A STENT AND ADD'L SURGERY AT A LATER DATE, WAS REQUIRED TO REMOVE THE BASKET.
PT EXPERIENCING URINARY RETENTION AND HEMATURIA. PHYSICIAN UNABLE TO REMOVE FOLEY AFTER TRYING TO DEFLATE BALLOON. PT BROUGHT TO OR AND CATHETER REMOVED WITH PT UNDER IVCS. BALLOON WAS STILL INFLATED ON REMOVAL.
THIS 30-YEAR-OLD MALE MULTIPLE TRAUMA WAS ADMITTED VIA THE EMERGENCY ROOM AND TAKEN TO THE OPERATING ROOM FOR ORIF OF THE LEFT HIP. DURING SURGERY, THE TIP OF THE CANNULATED SCREWDRIVER BROKE OFF AND COULD NOT BE RETRIEVED. THE TIP REMAINS IN THE SOFT TISSUE OF THE PT'S LEFT HIP AS A FOREIGN BODY.
EXTERNAL 12V RECHARGEABLE NICAD BATTERY (1.6 LB) SHORTED OUT AND STARTED BURNING WHEN PUMP STARTED. PT WAS ABLE TO SMOTHER FLAMES WITH A TOWEL. POSSIBLE WIRING PROBLEMS AT PLUG.
AN 8 LB. 10 OZ. VIABLE FEMALE DELIVERED VIA ASSISTED DELIVERY (X 5 PULLS) WITH SECONDARY SEVERE SHOULDER DYSTOCIA. APGARS 6/7, CORD PH 7.28. FOLLOWING DELIVERY, INFANT DETERIORATED UNTIL EVENTFUL DEATH AT 7:55. AUTOPSY REVEALED CEPHAL HEMATOMA AND DEATH SECONDARY TO INTRACRANIAL BLEEDING.
FIFTY FIVE-YEAR-OLD MALE RECEIVING TPN VIA RIGHT SUBCLAVIAN CATHETER, FOUND TO HAVE LEAKAGE FROM EXTERNAL CATHETER TUBING, NOT AMENABLE TO REPAIR WITH REPAIR KIT. PT SUBSEQUENTLY UNDERWENT REMOVAL OF THE CATHETER AND INSERTION OF LEFT SUBCLAVIAN CATHETER.
ONE OF THE VALVES ON THE HYPERINFLATION BAG FAILED. THE BABY WAS NOT GETTING ANY OXYGEN. THE BABY HAD TO BE MED-EVACED TO ANOTHER HOSPITAL DUE TO THIS PROBLEM. RPTR HAS NO INFORMATION ON THE BABY'S CONDITION.
URINE WOULD NOT FLOW FROM THE DRIP CHAMBER TO THE COLLECTION BAG.
AFTER REMOVING THE ORAL ENDOTRACHEAL TUBE HOLDER FROM THE PT'S MOUTH, RPTR NOTICED THAT THE PATIENT'S LOWER LIP HAD A NECROTIC HOLE, APPROXIMATELY 2 CM IN SIZE.
PT ADMITTED FOR ELECTIVE LAPAROSCOPIC BILATERAL SALPINGOOPHERECTOMY. LAPAROSCOPIC BSO PERFORMED AS PLANNED. WHILE IN RECOVERY ROOM, PT WENT INTO HYPOVOLEMIC SHOCK. STAT BLOOD DRAWN FOR TYPE AND CROSS AND HCT: 18.8 & HGB 6.6. PT'S SURGEON NOTIFIED AND GENERAL SURGEON CONSULTED. AFTER EXAMINING PT, SHE WAS BROUGHT BACK TO THE OPERATING ROOM FOR EXPLORATORY LAPAROSCOPY. ACTIVE BLEEDING WAS NOTED AND MD TRIED TO IDENTIFY SITE. BEING UNABLE TO LOCATE BLEEDING SITE, A EXPLORATORY LAPAROTOMY WAS PERFORMED, AND A MESENTERIC LACERATION WAS DISCOVERED AND REPAIRED. LACERATION APPEARED TO BE A TROCAR INJURY CAUSED DURING FIRST PROCEDURE. THREE UNITS OF BLOOD TRANSFUSED INTRAOPERATIVELY. PT BROUGHT BACK TO RECOVERY ROOM AND LATER TRANSFERRED TO HOSP FOR INPATIENT STAY. DURING FOLLOW-UP PHONE CALL, IT WAS NOTED THAT PT HAD TO HAVE A URETERAL STENT PLACED IN THE RIGHT URETER ON 11/26/95 NOTED PERFORATION OF RIGHT URETER.
THREE NEW ANALYZERS WERE INSTALLED, TESTED AND CALIBRATED. ALL 3 CALIBRATED WITHIN NORMAL SPECIFICATIONS. WHILE IN PATIENT USE, IT WAS FOUND THAT THE ETCO2 LEVELS WERE READING LOW DUE TO LOW CALIBRATION GASES. EACH MULTIANALYZER CALIBRATION GAS BOTTLE WAS CHANGED ON EACH MACHINE AND REPLACED WITH A NEW BOTTLE. THE ANALYZERS THEN FUNCTIONED WITHIN NORMAL SPECIFICATIONS. NO ADVERSE EFFECT TO ANY PATIENTS.
SUBCUTANEOUS VENOUS ACCESS PORT INSERTED ON PT 6/12/95. X-RAYS TAKEN ON 11/22/95 SHOWED THAT THE PORT HAD BROKEN IN HALF. THE DISTAL ASPECT OF THE CATHETER WAS NOTED TO BE LODGED IN THE LIVER. THE PROXIMAL ASPECT OF THE CATHETER WAS NOTED IN THE RIGHT ATRIUM. A RIGHT COMMON FEMORAL VEIN APPROACH WAS USED TO RETRIEVE THE DISTAL PORTION OF THE CATHTER. THE PT TOLERATED THIS PROCEDURE WITHOUT DIFFICULTY. THIS PROCEDURE WAS CONDUCTED IN THE RADIOLOGY DEPARTMENT. THE PT WAS TAKEN TO THE OPERATING ROOM AND THE PORT WAS REMOVED FROM THE RIGHT CHEST. THE PT TOLERATED THIS PROCEDURE WELL. THE PT WANTS CATHETER RETURNED TO HER.
INTRAOCULAR LENS SPLIT UPON ATTEMPTED INSERTION IN PT'S EYE. LENS RETRIEVED. PT SUFFERED NO ILL EFFECTS.
PT HAD LAPAROSCOPIC TUBAL LIGATION SURGERY PERFORMED 11/3/95 USING AN ELECTRO-SURGICAL GENERATOR AND BIPOLAR FORCEPS. THE PT RETURNED TO THE EMERGENCY DEPARTMENT ON 11/6/95 WITH ABDOMINAL PAIN AND VOMITING. IT WAS DETERMINED THAT THE PT HAD MULTIPLE SMALL BOWEL BURNS AND PERFORATIONS. BOWEL RESECTION SURGERY PERFORMED 11/6/95. PT IS CURRENTLY RECOVERING IN I.C.U. AND BEING CLOSELY OBSERVED FOR SIGNS OF SEPSIS.
ATTEMPTED REMOVAL OF POLYP USING SNARE. LOOP WOULD NOT CLOSE. UPON WITHDRAWAL OF SNARE IT WAS DISCOVERED THAT THE WIRE LOOP REMAINED IN THE COLON. IT WAS REMOVED AS THE SCOPE WAS WITHDRAWN. NO APPARENT INJURY TO THE PATIENT.
RECENTLY RPTR HAS OBSERVED IN SEVERAL LONG TERM CARE FACILITIES LATEX DISPOSABLE GLOVES BEING USED WHICH ARE LABELED "NOT FOR MEDICAL USE." THE ONLY MARKINGS ON THE BOX ARE ON THE ENCLOSED END FLAP. THE BOX HAS NO OTHER IDENTIFICATION, NOT EVEN A COUNT. RPTR ASKS IF THERE IS ANYTHING WRONG WITH USING THIS PRODUCT ON RESIDENTS. (*)
PT HAD LAPAROSCOPIC TUBAL LIGATION SURGERY PERFORMED 11/3/95 USING ANELECTRO-SURGICAL GENERATOR AND BIPOLAR FORCEPS. THE PT RETURNED TO THE EMERGENCY DEPARTMENT ON 11/6/95 WITH ABDOMINAL PAIN AND VOMITING. IT WAS DETERMINED THAT PT HAD MULTIPLE SMALL BOWEL BURNS AND PERFORATIONS. BOWEL RESECTION SURGERY PERFORMED 11/6/95. PT IS CURRENTLY RECOVERING IN I.C.U. AND BEING CLOSELY OBSERVED FOR SIGNS OF SEPSIS.
PT HAD LAPAROSCOPIC TUBAL LIGATION SURGERY PERFORMED 11/3/95 USING A ELECTROSURGICAL GENERATOR AND BIPOLAR FORCEP. THE PT RETURNED TO THE EMERGENCY DEPARTMENT ON 11/6/95 WITH ABDOMINAL PAIN AND VOMITING. IT WAS DETERMINED THAT PT HAD MULTIPLE SMALL BOWEL BURNS AND PERFORATIONS. BOWEL RESECTION SURGERY PERFORMED 11/6/95. PT IS CURENTLY RECOVERING IN I.C.U. AND BEING CLOSELY OBSERVED FOR SIGNS OF SEPSIS.
RPTR HAD SPINAL FUSION WITH PEDICLE SCREWS. SCREWS HIT A NERVE, CAUSING NERVE DAMAGE DOWN RIGHT LEG AND FOOT AND CAUSING PERMANENT FOOTDROP IN RIGHT FOOT. THE SCREW WAS TOO LONG AND IT WENT RIGHT THROUGH THE VERTEBRAE AND HIT A NERVE. IT WAS AS MUCH THE DOCTOR'S FAULT AS THE SCREW'S FAULT; THEY WERE BOTH WRONG FOR THE JOB. SECOND SPINAL FUSION DONE 10 DAYS AFTER FIRST FUSION TO TRY TO FIX NERVE DAMAGE, WAS NOT SUCCESSFUL. RPTR HAS SINCE HAD TWO MORE SPINAL FUSIONS WITH THE SCREWS REPLACED THREE TIMES. RPTR HAS BEEN THROUGH TOTAL HELL BECAUSE OF THESE SCREWS AND THE DOCTORS NOT USING THEM RIGHT. SHE'LL SPEAK UP AGAINST THEIR USE ANY TIME.
RPTR'S SILICONE IMPLANTS COMPLETELY DETERIORATED IN HER BODY. SILICONE WAS IN HER BODY WITHOUT THE SILICONE BAG. MEDICAL RECORDS ARE AVAILABLE TO THIS EFFECT. IT HAS AFFECTED HER EYES AND NECK. SHE WORE A NECK BRACE 1983-1984.
RPTR C/O SUDDEN ONSET OF SEVERE FATIGUE, JOINT PAIN, SWELLING AND STIFFNESS, HAIR LOSS, HEADACHE, CHEST PAIN, PALPITATIONS SHORTNESS OF BREATH, COLD AND NUMB FINGERS AND TOES, ORAL ULCER, SUDDEN ONSET OF MULTIPLE MEDICAL PROBLEMS REASON UNKNOWN, FREQUENT COLDS AND FLU. 2/96 FOUND OUT PROBLEMS COULD BE FROM BREAST IMPLANTS.
IRRADIATED LEUKOCYTE - POOR FILTERED PLATELETS TO BE TRANSFUSED. 3 DIFFERENT FILTERS ATTEMPTED, ALL IN THE SAME LOT NUMBER. UNABLE TO TRANSFUSE. 1/2 OF UNIT WAS WASTED. THE PT WAS TRANSFUSED WITH REGULAR BLOOD TUBING TO FINISH THE PLATELETS. PT WAS CMV NEGATIVE PRIOR TO THIS TRANSFUSION. UNKNOWN IF THIS WILL CAUSE PT TO BECOME CMV POSITIVE.
50 ML CASSETTE HAS A HAIR INSIDE THE HARD PLASTIC SHELL AND OUTSIDE OF PLASTIC MEMBRANE.
RN ADMINISTERED INSULIN TO A PT. IN ATTEMPTING TO ENGAGE PROTECTIVE SHEATH, THE SHEATH CAME OFF THE END OF THE SYRINGE AND THE NEEDLE PIERCED THE SKIN OF THE RN'S HAND. THIS WAS THE FIRST INCIDENT OF THIS KIND NOTED WITH THIS DEVICE. RPTR CONCERNED ABOUT FUTURE USE.
ELECTRODE TIP STARTED SMOKING AND MELTED AND BURNED PLASTIC TYPE INSULATION ON END OF ELECTRODE ON 2 DEVICES. A 3RD DEVICE FROM A DIFFERENT LOT NUMBER WAS OPENED AND USED WITHOUT ANY ADVERSE EFFECTS. DEVICE BEING USED WITH COAGULATION SETTING AT "30", CUTTING SETTING "O". COMPANY NOTIFIED. DEFECTIVE PRODUCT WITH ONE OTHER DEVICE WITH SAME LOT # SENT TO COMPANY. NO APPARENT PT HARM PER SURGEON.
WHEN ASSISTING THE PT TO TURN IN BED, HER PERIPHERALLY-INSERTED CENTRAL CATHETER (PICC) SEPARTED FROM THE HUB CONNECTION POINT. THE NURSE ASSISTING, HELD THE END OF THE CATHETER AND SUMMONED HELP. THE PICC WAS DISCONTINUED WITHOUT DIFFICULTY.
WHILE USING TACTYL NONLATEX HYPO-ALLERGENIC GLOVES IN A TOTAL HIP REPLACEMENT WITH METHYLMETHACRYLATE PRESENT, IT WAS NOTED THAT, AT THE POINT WHEN THE GLOVES CAME IN CONTACT WITH THE METHYLMETHACRYLTE, THE GLOVES ESSENTIALLY SEEMED TO MELT. THIS RESULTED IN THE SURGEON'S THUMB BEING NO LONGER PROTECTED BY THE GLOVE AND THE THUMB GOING INTO THE METHYLMETHACRYLATE. THIS EXPOSED THE PT TO A POTENTIAL OF INFECTION. AT THE END OF THE CASE, TO CONFIRM RPTR'S SUSPICIONS THAT THE GLOVE HAD DISSOLVED IN THE PRESENCE OF METHYLMETHACRYLATE, RPTR PUT SOME METHYLMETHACRYLATE AGAINST 2 GLOVES AND NOTICED THAT THE GLOVES SEEMED TO MELT. THEY HAD THEREFORE TREATED THE PT APPROPRIATELY WITH DEBRIDEMENT, IRRIGATION, AND ANTIBIOTICS. AT THIS POINT IT IS NOT CLEAR WHETHER OR NOT AN INFECTION WILL OCCUR. RPTR HAS ALSO NOTIFIED THE MFR RPTR. HAS LET THEM KNOW THAT THIS OCCURRED. RPTR RECOMMENDED THAT THEY CHANGE THEIR LABELING TO MAKE IT CLEAR THAT THESE GLOVES SHOULD NOT BE USED IN THE PRESENCE OF METHYLMETHACRYLATE. THE COMPANY REPORTED THAT THEY DO INCLUDE A SPECIFICATION SHEET WITH THE GLOVES WHICH WAS SUPPOSED TO BE AT RPTR'S HOSPITAL. RPTR HAS REVIEWED THE SPECIFICATION SHEET. THE SHEET MENTIONS THAT THE GLOVES ARE SOLUBLE OR SOFTENED BY ALIPHATIC, AROMATIC, AND CHLORINATED HYDROCARBONS, KETONES, ESTERS, ETHERS, AND ALCOHOLS. THERE IS NO SPECIFIC MENTION OF METHYLMETHACRYLATE ALTHOUGH RPTR SUSPECTS IT DOES FALL INTO ONE OF THOSE CHEMICAL CLASSIFICATIONS. THE HOSPITAL PURCHASING DEPARTMENT REPORTS THAT THEY DID NOT HAVE A COPY OF THE SPECIFICATION SHEET UNTIL AFTER THIS INCIDENT AND THE COMPANY SUBSEQUENTLY PROVIDED THAT SPECIFICATION SHEET. RPTR THINKS WITH OR WITHOUT THE SPECIFICATION SHEET IN A REAL-WORLD SENSE THE COMPANY NEEDS TO BE MORE SPECIFIC IN NOTIFYING USERS ABOUT THE RISK OF THESE GLOVES SOFTENING OR DISSOLVING IN THE PRESENCE OF METHYLMETHACRYLATE AND RPTR DOES NOT THINK THE AVERAGE HOSPITAL PURCHASING DEPARTMENT IS ABLE TO UNDERSTAND THE PRECISE CHEMISTRY OF METHYLMETHACRYLATE. RPTR WOULD RECOMMEND A CHANGE IN THE LABELING FOR THESE GLOVES AND NOTIFICATION OF OTHER USERS OF THESE GLOVES THAT THIS IS A PROBLEM.
SUSPECTED FAILURE OF MECHANICAL HEART VALVE, REQUIRING THAT THE VALVE BE REPLACED.
SURGEON WAS USING SOFT TIP IN SCLEROTOMY SITE TO RELEASE AIR DURING GAS EXCHANGE. WHEN SOFT TIP EXTRUSION CANNULA WAS REMOVED, THE SILICONE TIP WAS LEFT BEHIND IN THE POSTERIOR SEGMENT OF THE EYE. SURGEON THEN WENT INTO THE POSTERIOR CHAMBER TO RETRIEVE SILICONE TIP WITH TWO INTRAOCULAR FORCEPS. TIP WAS REMOVED FROM EYE AND THE EYE WAS CLOSED AS USUAL.
DURING APPENDECTOMY THIS DEVICE IS SUPPOSED TO LAY IN A LINE OF STAPLES AND CUT BETWEEN. NO STAPLES CAME OUT, SO THE INSTRUMENT WAS ONLY CUTTING, CAUSING BLEEDING. THE PT HAD TO BE OPENED UP TO CONTROL BLEEDING AND REMOVE APPENDIX. THIS WILL CAUSE PROLONGED HOSPITAL STAY AND A LONGER RECOVERY PERIOD.
AFTER IMPLANTING LENS INTO THE RIGHT EYE, IT WAS NOTICED THAT THE HAPTIC WAS BROKEN OFF IN THE EYE. THE LENS WAS INSERTED AND REMOVED. IT WAS NOT USED.
PT HAD CATHETER IN FOR 4 MONTHS. CATHETER TIP BROKE OFF WITHIN THE BLOOD VESSEL. PT REQUIRED ANGIOGRAPHY TO OBTAIN TIP.
FRACTURED ATRIAL PACING WIRE CAUSED ATRIAL PERFORATION AND PERICARDIAL TAMPONADE. REMOVED FRACTURED WIRE.
INTERMEDULLARY ROD BROKE IN FEMUR. REMOVED (GIVEN TO FAMILY BY MD) AND REPLACED. (NON-UNION OF BONE)
IN AUGUST 1986 RPTR HAD A BILATERAL SUBCUTANEOUS MASTECTOMY AND RECONSTRUCTION WITH SILICONE SALINE EXPANDERS. IN SEPTEMBER SHE HAD DRAINAGE FROM RIGHT BREAST. THE EXPANDER WAS COMING THROUGH THE SKIN AND HAD TO BE REMOVED. IN OCTOBER HER LEFT BREAST STARTED DRAINING. THE DOCTOR FOUND A SERRATIA INFECTION AND LEFT BREAST EXPANDER HAD TO BE REMOVED. IN FEBRUARY 1987 SHE HAD BREAST IMPLANTS INSERTED. THE RESULT WAS HER LEFT BREAST WAS HARD AS A BASEBALL AND HER RIGHT BREAST DEVELOPED AN INFECTION BELOW THE NIPPLE. SHE STARTED BLEEDING LATER THAT YEAR AND WAS RETURNED TO SURGERY. SHE WAS GIVEN 4 PINTS OF BLOOD. SHE WOKE UP DURING THIS TIME IN SURGERY, HAD A SEIZURE. TWO DAYS AFTER LEAVING THE HOSPITAL, THE RIGHT BREAST STARTED DRAINING. THE DOCTOR FOUND SERRATIA. AFTER TREATMENT THE RIGHT IMPLANT HAD TO BE REMOVED. IN APRIL 1989 SHE CONTACTED THE DOCTOR FOR FURTHER RECONSTRUCTION. AT THIS TIME SHE HAD NO IMPLANT IN HER RIGHT BREAST. SHE ALSO HAD SEVERE SCARRING AND CAPSULAR CONTRACTURE. SHE HAD SURGERY WHERE LEFT INFRAMAMMARY SCAR WAS REMOVED. AN INTACT BI-LUMEN 285 CC IMPLANT WAS REMOVED AND A 385 CC GEL-FILLED IMPLANT WAS PLACED IN HER LEFT BREAST, RIGHT INFRAMAMMARY SCAR AND SKIN PADDLE WERE REMOVED AND A 600 CC TISSUE EXPANDER WAS PLACED IN THE POCKET AND FILLED TO 200 CC. IN NOVEMBER THE DOCTOR REMOVED THE RIGHT BREAST EXPANDER AND REPLACED IT WITH A PERMANENT IMPLANT. SCARRING AND HARDNESS PROBLEMS CONTINUED. RESULTS WERE UNSATISFACTORY. IN 1989 SHE HAD SURGERY FOR SCARRING PROBLEMS, HARDENING, AND RELIEF OF CONTINUED PAIN. RESULTS OF THIS SURGERY WERE UNSATISFACTORY. IN 1990 SHE HAD HARDNESS OF IMPLANTS, PROLONGED PAIN AND STIFFNESS OF JOINTS CONTINUED. IN 1991 REMOVAL OF RIGHT BREAST AND REPLACEMENT WITH A TRANSRECTUS ABDOMINUS MYOCUTANEOUS BREAST FLAP. IN SEPTEMBER SHE HAD NIPPLE RECONSTRUCTION. SHE DEVELOPED SERRATIA. IN DECEMBER 1992 SHE ALMOST DIED OF BACTERIAL SPINAL MENINGITIS. THE DR SAID IT WAS MENNINGOCOCCAL SERRATIA MENINGITIS.
IN AUGUST 1986 RPTR HAD A BILATERAL SUBCUTANEOUS MASTECTOMY AND RECONSTRUCTION WITH SILICONE SALINE EXPANDERS. IN SEPTEMBER SHE HAD DRAINAGE FROM RIGHT BREAST. THE EXPANDER WAS COMING THROUGH THE SKIN AND HAD TO BE REMOVED. IN OCTOBER HER LEFT BREAST STARTED DRAINING. THE DOCTOR FOUND A SERRATIA INFECTION AND LEFT BREAST EXPANDER HAD TO BE REMOVED. IN FEBRUARY 1987 SHE HAD BREAST IMPLANTS INSERTED. THE RESULT WAS HER LEFT BREAST WAS HARD AS A BASEBALL AND HER RIGHT BREAST DEVELOPED AN INFECTION BELOW THE NIPPLE. SHE STARTED BLEEDING LATER THAT YEAR AND WAS RETURNED TO SURGERY. SHE WAS GIVEN 4 PINTS OF BLOOD. SHE WOKE UP DURING THIS TIME IN SURGERY, HAD A SEIZURE. TWO DAYS AFTER LEAVING THE HOSPITAL, THE RIGHT BREAST STARTED DRAINING. THE DOCTOR FOUND SERRATIA. AFTER TREATMENT THE RIGHT IMPLANT HAD TO BE REMOVED. IN APRIL 1988 SHE CONTACTED THE DOCTOR FOR FURTHER RECONSTRUCTION. AT THIS TIME SHE HAD NO IMPLANT IN HER RIGHT BREAST. SHE ALSO HAD SEVERE SCARRING AND CAPSULAR CONTRACTURE. SHE HAD SURGERY WHERE LEFT INFRAMAMMARY SCAR WAS REMOVED. AN INTACT BI-LUMEN 285 CC IMPLANT WAS REMOVED AND A 385 CC GEL-FILLED IMPLANT WAS PLACED IN HER LEFT BREAST, RIGHT INFRAMAMMARY SCAR AND SKIN PADDLE WERE REMOVED AND A 600 CC TISSUE EXPANDER WAS PLACED IN THE POCKET AND FILLED TO 200 CC. IN NOVEMBER THE DOCTOR REMOVED THE RIGHT BREAST EXPANDER AND REPLACED IT WITH A PERMANENT IMPLANT. SCARRING AND HARDNESS PROBLEMS CONTINUED. RESULTS WERE UNSATISFACTORY. IN 1989 SHE HAD SURGERY FOR SCARRING PROBLEMS, HARDENING, AND RELIEF OF CONTINUED PAIN. RESULTS OF THIS SURGERY WERE UNSATISFACTORY. IN 1990 SHE HAD HARDNESS OF IMPLANTS, PROLONGED PAIN AND STIFFNESS OF JOINTS CONTINUED. IN 1991 REMOVAL OF RIGHT BREAST AND REPLACEMENT WITH A TRANSRECTUS ABDOMINUS MYOCUTANEOUS BREAST FLAP. IN SEPTEMBER SHE HAD NIPPLE RECONSTRUCTION. SHE DEVELOPED SERRATIA. IN DECEMBER 1992 SHE ALMOST DIED OF BACTERIAL SPINAL MENINGITIS. THE DR SAID IT WAS MENNINGOCOCCAL SERRATIA MENINGITIS. (ALSO SEE 1008447 AND 1008448)
IN AUGUST 1986 RPTR HAD A BILATERAL SUBCUTANEOUS MASTECTOMY AND RECONSTRUCTION WITH SILICONE SALINE EXPANDERS. IN SEPTEMBER SHE HAD DRAINAGE FROM RIGHT BREAST. THE EXPANDER WAS COMING THROUGH THE SKIN AND HAD TO BE REMOVED. IN OCTOBER HER LEFT BREAST STARTED DRAINING. THE DOCTOR FOUND A SERRATIA INFECTION AND LEFT BREAST EXPANDER HAD TO BE REMOVED. IN FEBRUARY 1987 SHE HAD BREAST IMPLANTS INSERTED. THE RESULT WAS HER LEFT BREAST WAS HARD AS A BASEBALL AND HER RIGHT BREAST DEVELOPED AN INFECTION BELOW THE NIPPLE. SHE STARTED BLEEDING LATER THAT YEAR AND WAS RETURNED TO SURGERY. SHE WAS GIVEN 4 PINTS OF BLOOD. SHE WOKE UP DURING THIS TIME IN SURGERY, HAD A SEIZURE. TWO DAYS AFTER LEAVING THE HOSPITAL, THE RIGHT BREAST STARTED DRAINING. THE DOCTOR FOUND SERRATIA. AFTER TREATMENT THE RIGHT IMPLANT HAD TO BE REMOVED. IN APRIL 1988 SHE CONTACTED THE DOCTOR FOR FURTHER RECONSTRUCTION. AT THIS TIME SHE HAD NO IMPLANT IN HER RIGHT BREAST. SHE ALSO HAD SEVERE SCARRING AND CAPSULAR CONTRACTURE. SHE HAD SURGERY WHERE LEFT INFRAMAMMARY SCAR WAS REMOVED. AN INTACT BI-LUMEN 285 CC IMPLANT WAS REMOVED AND A 385 CC GEL-FILLED IMPLANT WAS PLACED IN HER LEFT BREAST, RIGHT INFRAMAMMARY SCAR AND SKIN PADDLE WERE REMOVED AND A 600 CC TISSUE EXPANDER WAS PLACED IN THE POCKET AND FILLED TO 200 CC. IN NOVEMBER THE DOCTOR REMOVED THE RIGHT BREAST EXPANDER AND REPLACED IT WITH A PERMANENT IMPLANT. SCARRING AND HARDNESS PROBLEMS CONTINUED. RESULTS WERE UNSATISFACTORY. IN 1989 SHE HAD SURGERY FOR SCARRING PROBLEMS, HARDENING, AND RELIEF OF CONTINUED PAIN. RESULTS OF THIS SURGERY WERE UNSATISFACTORY. IN 1990 SHE HAD HARDNESS OF IMPLANTS, PROLONGED PAIN AND STIFFNESS OF JOINTS CONTINUED. IN 1991 REMOVAL OF RIGHT BREAST AND REPLACEMENT WITH A TRANSRECTUS ABDOMINUS MYOCUTANEOUS BREAST FLAP. IN SEPTEMBER SHE HAD NIPPLE RECONSTRUCTION. SHE DEVELOPED SERRATIA. IN DECEMBER 1992 SHE ALMOST DIED OF BACTERIAL SPINAL MENINGITIS. THE DR SAID IT WAS MENNINGOCOCCAL SERRATIA MENINGITIS. (ALSO SEE 1008446 AND 1008448)
RPTR HAD BREAST IMPLANTS IMPLANTED. SHE HAD A SERRATIA INFECTION AND C/O LUPUS. ALSO SEE 1008446 AND 1008447)
10/1/79 RPTR HAD RASH ON SACRUM WHICH RECURRED EVERY 5-7 MONTHS UNTIL IMPLANTS EXPLANTED. IN 1980 SHE STARTED HAVING NAUSEA WHICH LASTED 2 OR 3 DAYS AND MOW LASTS FOR 3 OR 4 WEEKS AT A TIME. SUMMER/FALL 1987 SHE HAD INFLAMMED RIGHT TMJ FROM TENSION/FIBROMYALGIA IN NECK AND JAW MUSCLES. THIS RECURS IN SPITE OF WEARING A MOUTH SPLINT EVERY NIGHT. 9/92 - 6/93 FLU-LIKE SYMPTOMS OF NAUSEA, VOMITING, DIARRHEA, HEADACHES, MUSCLE AND JOINT SORENESS AND PAIN, SORE THROAT; EXTREME FATIGUE, MEMORY LOSS AND INSOMNIA, RECURS STILL IN VARYING DEGREES OF SEVERITY DEPENDING ON LEVEL OF ACTIVITY. FALL '95 ANGER AND DEPRESSION BECAUSE SHE IS NOT BETTER.
RPTR HAD BREAST IMPLANTS IMPLANTED 6/2/77. THE RIGHT IMPLANT RUPTURED AND SHE HAD BLEEDING THROUGH THE ENVELOPE. A MEDICAL PROFESSIONAL CONFIRMED SILICONE OUTSIDE THE LEFT CAPSULE. SHE C/O PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, OTHER NEUROPATHY, MOTOR NEURON DISEASE, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, BALANCE DISTURBANCES, ATYPICAL M-S, ELEVATED CHOLESTEROL OR TRIGLICERIDES, THYROID PROBLEMS, HEAT OR COLD SENSITIVITY OF EXTREMITIES, CHRONIC DIARRHEA, IRRITABLE BOWEL SYNDROME, DIFFICULTY SWALLOWING, HYSTERECTOMY, OOPHORECTOMY, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, ARRHYTHMIAS, TACHYCARDIA, CONNECTIVE TISSUE DISEASE, ATYPICAL LUPUS, SJOGREN'S SYNDROME, SCLERODERMA, RESTRICTIVE COPD, UNEXPLAINED RASHES, SUN SENSITIVITY, DERMATOMYOSITIS, NON-RESTORATIVE SLEEP, VASCULITIS, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, CLUMSINESS/DROPS THINGS, SICCA.
DOME FAILED TO RETAIN AIR EVEN AFTER CONNECTIONS WERE CHECKED. DISCHARGE INFORMATION INCLUDES EXTENSIVE ECCHYMOSIS OF THE RIGHT GROIN AND AN AREA OF BLISTERING FROM THE DEVICE USED TO STEM BLEEDING FROM GROIN.
ONE PT PRESENTED TO ER WITH BLOODY DRAINAGE AND LEAKING UNDER PORT DRESSING. DRESSING REMOVED. FOUND PORT NEEDLE STILL IN PLACE WITH WINGS (GRIPPERS) DETACHED. SUCCESSFULLY REMOVED DEFECTIVE PORT NEEDLE AND FLUSHED IMPLANTED PORT WITHOUT INCIDENT OR EVIDENCE OF COMPLICATIONS. A SECOND PT PRESENTED TO DEPARTMENT WITH SAME PROBLEM AS DESCRIBED ABOVE AND SAME OUTCOME. NEITHER PT RECALLS INJURY OR PULLING OF EQUIPMENT. BOTH PT'S FOLLOWED BY SAME INFUSION COMPANY USING SAME EQUIPMENT. (*)
DURING PROCEDURE IN OR, PHACOEMULSIFICATION MACHINE WAS NOT FUNCTIONING PROPERLY. IT WAS FOUND THAT THE PHACO HAND PIECE HAD BEEN PLUGGED INTO THE WRONG CONNECTOR. DURING THIS CATARACT SURGERY, THE BACK WALL OF THE EYE WAS PUNCTURED, REQUIRING A SECOND SURGERY TO CORRECT PROBLEM. INCIDENT FELT TO BE CAUSED BY USER ERROR IN OPERATING THE MACHINE INCORRECTLY AND PHYSICIAN'S UNFAMILIARITY WITH THE MACHINE. IT HAS BEEN DETERMINED THAT THERE ARE 2 DIFFERENT HANDPIECES USED WITH THE PHACOEMULSIFIER. EITHER HANDPIECE CAN BE PLUGGED INTO EITHER PORT, BUT IF THE WRONG HANDPIECE IS PLUGGED INTO THE WRONG PORT, THE UNIT WILL NOT OPERATE PROPERLY. THERE WAS NO EQUIPMENT MALFUNCTION IN THIS INCIDENT. THE INOPERABLE EQUIPMENT CAN BE ATTRIBUTED TO USER ERROR.
PT ORIGINALLY HOSPITALIZED 11/1/95. A DOUBLE LUMEN CATHETER WAS PLACED WITHOUT INCIDENT FOR TPN. PT WAS SEEN IN ED 11/12/95 AND A HOLE PROXIMAL TO THE CUFF WAS DISCOVERED. TPN WAS INFUSING INTO THE SUBCUTANEOUS TISSUE.
ON 8/9/95 PT HAD A TOTAL PROCTOCOLECTOMY WITH ILEAL J-POUCH ANAL ANASTOMOSIS FOR CHRONIC ULCERATIVE COLITIS. ON 8/31/95 A PRESACRAL ABSCESS WAS NOTED AND DRAINED USING AN ALL PURPOSE DRAINAGE CATHETER SET. UNDER CT GUIDE A 2-3 CM FRAGMENT OF THE DISTAL PORTION OF THE CATHETER BROKE OFF FROM THE TIP AND WAS RETAINED IN THE RIGHT GLUTEAL REGION. UNDER CT GUIDANCE ANOTHER PROCEDURE WAS DONE AND FRAGMENT RETRIEVED.
PT INITIALLY HAD TOTAL KNEE REPLACEMENT OF RIGHT KNEE IN NOVEMBER WITH REVISION IN NOVEMBER OF 1994. MARCH 1995 HAD SEVERE PAIN IN RIGHT KNEE; X-RAY SHOWED RIGHT KNEE DISLOCATION. PT TAKEN TO OR FOR CLOSED REDUCTION AND PLACEMENT OF CYLINDER CAST. PT SEEN IN OFFICE FOR CAST REMOVAL; WHEN REMOVED, DEFORMITY AGAIN NOTED AND X-RAY CONFIRMED DISLOCATION. ON 4/20/95 ADMITTED FOR CLOSED REDUCTION. AT OR, CLOSED REDUCTION WAS NOT ABLE TO BE DONE. PT PLACED IN UNIVERSAL BRACE. ADD'L CAT # 1890-0112, 1808-0303, 1870-0464, 1808-0300. ADD'L LOT # 063M802421, 101M638360, 084M095108, 094M176235, 054M103472.
PT ADMITTED WITH NAUSEA/VOMITING, FEVER. CATHETER IN PLACE FOR CHEMOTHERAPY. TO OR 5/17/95 FOR REMOVAL OF INFECTED CATHETER.
PT HAD LEFT TOTAL KNEE REPLACEMENT IN 1989. DID WELL UNTIL 5/95 WHEN DEVELOPED JOINT EFFUSION. ARTHROSCOPY SHOWED NEED FOR REVISION. METAL IS EXPOSED AND JOINT SURFACE BUTTON HAS FAILED PER MD HISTORY AND PHYSICAL. PT TO OR 6/23/95 FOR REVISION OF LEFT TOTAL KNEE AND SYNOVECTOMY OVER THE LEFT KNEE. ADD'L CAT # 1841-9126, 1840-0008, 1841-9127, 1840-0234, 1841-9126. ADD'L LOT # M315900, M299828, M307710, M307860, 08717852, M299020.
PT HAD LEFT TOTAL HIP REPLACEMENT 10/11/93. ADMITTED 2/12/95 WITH DISLOCATION OF LEFT HIP. PT WAS BENDING OVER DUSTING FURNITURE WHEN DISLOCATION OCCURRED. CLOSED REDUCTION OF LEFT HIP DONE. 3/8/95 ADMITTED WITH DISLOCATION OF LEFT HIP PROSTHESIS. CLOSED REDUCTION DONE. 4/17/95 ADMITTED WITH DISLOCATION LEFT HIP PROSTHESIS. CLOSED REDUCTION DONE. ADD'L CAT # 6624-65-25, 6728-87, 9026-28, 6630-13. ADD'L LOT # 44242600, 48809700, 43744900.
PT HAS HAD SEVERAL EPISODES OF PERITONITIS, ALL WITH STAPH EPIDERMIDIS, SINCE FEBRUARY THIS YEAR. IT IS BELIEVED THERE WAS A DEFECT IN THE PD CATHETER. TO OR 6/19/95 FOR REMOVAL OF CAPD CATHETER WITH EXTERIORIZATION OF THE CATHETER INSERTED 5/18/95.
PT HAD OPEN REDUCTION, INTERNAL FIXATION OF RIGHT FEMUR IN 1994 FOLLOWING AUTO ACCIDENT. FRACTURES HAVE HEALED BUT C/O PERSISTANT PAIN IN THE RIGHT BUTTOCK WITH A FEMORAL NAIL PRESENT. ADMITTED FOR ELECTIVE REMOVAL OF HARDWARE FROM THE RIGHT FEMUR.
PT HAD RUPTURED LEFT BREAST IMPLANT REMOVED SURGICALLY.
ASPIRATION NEEDLE BROKE OFF DURING ILIAC BONE MARROW BIOPSY. ORTHOPEDIC SURGEON CALLED. PT TAKEN FOR SURGICAL PROCEDURE TO REMOVE NEEDLE.
CAROTID STENT LOOSENED AND MIGRATED TO THE RIGHT FEMORAL ARTERY DURING PLACEMENT PROCEDURE IN LEFT CAROTID ARTERY. STENT REMAINS IN PT.
INTRA-AORTIC BALLOON RUPTURED AND WAS REMOVED.
PACEMAKER REPLACED DUE TO MALFUNCTION. PACEMAKER WAS ON RECALL. PT WAS EXPERIENCING WEAKNESS AND FATIGUE.
STAPLES DID NOT CLOSE. THEY REMAINED OPEN. STAPLER WAS BEING USED ON STOMACH. PHYSICIAN THEN HAD TO USE CLAMPS TO STOP BLEEDING AND SUTURE STOMACH.
STAPLES ON STAPLER DID NOT CLOSE AND REMAINED OPEN. PHYSICIAN THEN HAD TO USE CLAMPS TO CONTROL BLEEDING OF STOMACH AND SUTURE.
PT UNDERGOING KNEE ARTHROSCOPY WHEN IT WAS NOTED ON TV SCREEN THAT A MINUTE FOREIGN BODY WAS PRESENT. UPON EXAMINING EQUIPMENT, FOUND THAT A SMALL PIECE DISTAL TO THE HINGE OF ANGLE SCISSORS HAD BROKEN OFF. THE PIECE WAS PRESENT POST-LAT ON X-RAY. UNABLE TO FIND OR EXTRACT INTRA-OP.
APPROXIMATELY 15" INTO DIAGNOSTIC ARTHROSCOPY, USING PUMP MACHINE, ALARM SOUNDED. OUTFLOW TUBING FOUND OFF AND TURNED ON. MACHINE CONTINUED TO ALARM. SENSOR BALLOON FOUND DEFLATED. IT WAS DISCONNECTED, REINFLATED AND REATTACHED. PRESSURE FOUND TO BE 451. PUMP TURNED OFF. EXAM OF RIGHT LOWER EXTREMITY REVEALED SWELLING. PROCEDURE ABORTED AND FASCIOTOMY PERFORMED.
PT TO RECEIVE INTRAVENOUS FLUIDS AT 200 CC/HR. PLACED ON IV PUMP. PUMP RATE SET TO DELIVER 200 CC/HR AND AMOUNT TO BE INFUSED SET AT 1000 CC. AT THE END OF 4 HRS THE PUMP REGISTERED 800 CC AS AMOUNT INFUSED BUT THERE WAS ONLY 100 CC GONE FROM THE 1000 CC BAG. THERE WAS NO MEDICATION ADDED TO THE IV FLUID.
OXYGEN CONCENTRATOR CAUGHT FIRE AT A PT'S HOME. THE SOURCE OF THE FIRE WAS THE OXYGEN CONCENTRATOR AND THERE WERE NO CONTRIBUTING FACTORS EXTERNAL TO THE DEVICE.
PT WAS DOING ISOKINETIC WORKOUT. WASHER WAS BROKEN. AND MACHINE TWISTED DUE TO TORQUE, WHICH CAUSED VALGUS STRESS ON THE JOINT.
TUBE INSERTED ON 12/23/95. A FLUOROSCOPY WAS DONE TO CHECK PLACEMENT. FLUOROSCOPY DEMONSTRATED LEAKAGE OF METALLIC MERCURY. ON 12/23/95 AN ESOPHAGASTRODUODENOSCOPY WAS PERFORMED TO EVACUATE THE MERCURY. A SMALL QUANTITY OF VERY FINE GRAIN MERCURY REMAINED IN THE STOMACH FOLLOWING THE PROCEDURE.
DURING AN EGD AND DILATION OF ESOPHAGUS, THE BALLOON OF A BALLOON DILATOR RIPPED AND DETACHED ITSELF FROM CATHETER. BALLOON BECAME LODGED IN PT'S ESOPHAGUS AND HAD TO BE REMOVED AS IF A FOREIGN BODY.
THE VENTRICULAR CATHETER WAS REMOVED. TWO DAYS LATER THE CT OF THE HEAD REVEALED "EXTERNAL PORTION OF THE VENTRICULAR DRAIN HAS BEEN REMOVED BUT THE INTERNAL PORTION FROM THE CALVARIUM TO THE OUTLET OF THE RIGHT VENTRICLE REMAINS IN PLACE." THIS RESULTED IN THE PT'S RETURN TO SURGERY FOR RETRIEVAL OF THE RETAINED PORTION.
ON 6/27/95, A SIZE 4 AIRWAY WAS INSERTED INTO PT UNDERGOING WRIST SURGERY. DEVICE WAS INFLATED WITH 20CC OF AIR. OPERATIVE MEDICATIONS INCLUDED FENTANYL, PROPOFOL, REGLAN, MORPHINE, ANCEF, NITROUS OXIDE AND ISOFLURANE. ON 6/30/95, DURING FOLLOW-UP CALL, PT COMPLAINED OF SEVERE SORE THROAT, DIFFICULTY SWALLOWING AND INTERMITTENT HOARSENESS. ON 7/3/95, PT SAW AN ENT SPECIALIST, WHO REPORTED A HEALING ULCERATION IN THE POSTERIOR HYPOPHARYNX. ON 7/7/95, PT REPORTED SORE THROAT WAS IMPROVING.
PT COMPLAINING OF PAIN, DISCOMFORT AND HARDNESS OF THE SCAR TISSUE AROUND IMPLANTS.
DURING PROCESS OF PTCA PROCEDURE, SYSTEM FAILED PREVENTING THE PHYSICIAN FROM VIEWING CATHETER PLACEMENT AND ALLOWING NORMAL PROGRESS OF TREATMENT. THE SYSTEM WAS RE-STARTED APPROXIMATELY NINE TIMES WITHOUT OPERATIONAL SUCCESS. CASE WAS ABORTED AND RE-INITIATED AFTER CO TECHNICIAN "CLEARED" DEVICE. CO TECHNICIAN INDICATED "UNIT OPERATING PROPERLY." THE SYSTEM HAS "LOCKED-UP" OR FAILED INTRAOPERATIVELY APPROXIMATELY 23 TIMES IN 7 MONTHS. TWO TO THREE CASES HAVE BEEN ABORTED.
THE STENT WAS ADVANCED INTO THE PROXIMAL CIRCUMFLEX. THE STENT WOULD NOT ADVANCE INTO THE LESION. THE STENT WAS THEN PULLED BACK BUT HUNG UP AND WAS UNABLE TO BE REMOVED. VARIOUS TECHNIQUES WERE UTILIZED TO REMOVE THE STENT, BUT WERE UNSUCCESSFUL. THE PT WAS HEMODYNAMICALLY STABLE AND WAS SENT TO THE OPERATING ROOM FOR ACBP.
SURGEON MADE THREE DIFFERENT INCISIONS INTO THE LEFT EYE SCLERA DURING A CATARACT EXTRACTION WITH IOL IMPLANT. SURGEON CLAIMED THE BLADE WENT TOO DEEP AND MIGHT BE DEFECTIVE. KNIFE WAS SENT TO MFR FOR CALIBRATION AND TESTING. RESULTS WERE NEGATIVE FOR ANY MISCALIBRATION OR OTHER DEFECTS. PT HAD PROLONGED PAIN.
ACCORDING TO NURSE, "PORT SPRANG A LEAK AFTER MEDICATION INJECTION."
PATIENT RECEIVED AN OVERINFUSION OF MS WHILE CONNECTED TO INFUSION PUMP. NURSE CHECKING IV BAGS ON 2/16 AT 1700 NOTICED IV BAG ALMOST EMPTY.  ORIGINALLY STARTED AT 12 NOON ON 2/16 AT RATE OF 5CC/HR.  FIVE TO 10CC REMAINED IN SOLUTION SET.  DEVICE REMOVED FROM SERVICE FOR EVALUATION ALONG WITH ALL TUBING AND SOLUTION SET.  EVALUATION BY IN-HOUSE BIO-MED STAFF COULD NOT DUPLICATE OVERINFUSION CAUSED BY DEVICE.
BILATERAL AUGMENTATION MAMMOPLASTY WAS PERFORMED ON THIS PT IN 1983 USING OLD STYLE SILICONE IMPLANTS WITH POSTERIOR FIXATION PATCHES. IN EARLY 1995 A MAMMOGRAM IDENTIFIED POSSIBLE LEAKAGE FROM RIGHT IMPLANT. MRI CONFIRMED LEAKAGE FROM LEFT AND RIGHT IMPLANTS. BY REPORT AND TO THE KNOWLEDGE OF THIS INVESTIGATOR, PT HAD NO COMPLAINTS RELATED TO THE IMPLANTS ASIDE FROM THE FACT THAT THEY WERE LEAKING. PT UNDERWENT REMOVAL OF BILATERAL BREAST IMPLANTS ON 6/29/95. THERE WAS AN OUTPOURING OF SILICONE GEL FROM THE FIBROUS CAPSULE SURROUNDING THE IMPLANTS. THE AREAS WERE CLEARED OF SILICONE GEL, FIXATION PATCHES WERE DISSECTED FROM PECTORALIS MAJOR MUSCLES. SALINE IMPLANTS WERE INSERTED. THE PT TOLERATED THE PROCEDURE WELL.
DURING THORACOTOMY/LOBECTOMY PROCEDURE, STAPLER COULD FIRST NOT BE OPENED.  WHEN IT WAS OPENED, STAPLES HAD MISFIRED.  PULMONARY ARTERY WAS SUTURED CLOSED.  NO UNTOWARD EFFECT ON PATIENT.  DEVICE TO BE RETURNED TO CO FOR EVALUATION.
STAFF NURSE HAD ACCIDENTALLY RECEIVED AN ARM-TO-ARM SHOCK WHILE PERFORMING A ROUTINE DEVICE SELF-TEST (200 JOULE SETTING).  NURSE ADMITTED TO ER FOR FOLLOW-UP TREATMENT AND ECG MONITORING.
AT 9 AM RPTR TOOK TEST IN HER LEFT ARM. THE MACHINE WAS TOO TIGHT AND HER ARM HURT FOR THE NEXT 3 MONTHS. HER ARM IS COLD ALL THE TIME, SOME TIMES IT IS NUMB AND SHE IS NOT ABLE TO LIFT LIKE BEFORE THE EVENT. LEFT HAND IS ALSO COLD. RPTR APPLIES HEAT, RUBS AND EXERCISES HER LEFT ARM TO HELP GET RELIEF. RPTR FEELS EVENT HAS AFFECTED ALL OF HER WORK. SHE DOES NOT TAKE ANY MEDICATION AND HAS NOT GONE TO A DOCTOR. (*)
INFUSION PUMP "BLEW UP" AND STARTED A FIRE. BURNED HOLE IN CARPET AND FLAMES SEARED FURNITURE. PT IS OKAY.
PT WAS TAKEN TO THE OPERATING ROOM FOR AN ELECTIVE C-SECTION FOR A TWIN PREGNANCY. NORMAL SURGICAL TECHNIQUES WERE USED INCLUDING USE OF THE BOVIE PENCIL. UPON ENTERING THE ABDOMINAL CAVITY, THE BOVIE WAS PLACED ON THE PT'S UPPER CHEST, CLEAR OF THE OPERATIVE FIELD. THE PT THEN COMPLAINED OF PAIN IN HER NECK AND IT WAS NOTED THAT THE CAUTERY PENCIL WAS INDEPENDENTLY FIRING. THIS CAUSED A 3 MM FULL THICKNESS BURN AND PARTIAL THICKNESS BURN TO THE PT'S NECK. THE SURGEON TOSSED THE PENCIL FROM THE FIELD BUT IT CAUGHT IN THE SURGICAL DRAPE RESULTING IN A SUPERFICIAL BURN TO THE PT'S RIGHT FOREARM. PT HAD SCARRING OF SKIN.
USING THE BOVIE UNIT AND HAD THE HAND HELD BOVIE AND FOOT CONTROL BOVIE BOTH CONNECTED. FOOT CONTROL UNIT WAS FOR THE SUCTION BOVIE USED ON T & A'S. SOMEHOW THE FOOT CONTROL ACTIVATED WITH THE HAND HELD AND THIS WAS NOT SUPPOSED TO HAPPEN. THE PHYSICIAN WAS NOT USING THE FOOT CONTROL SWITCH AT THAT TIME. SURGICAL TECH WAS HOLDING THE SUCTION BOVIE IN THE MOUTH TO SUCTION. WHEN FOOT CONTROL WAS ACTIVATED ACCIDENTLY IT CAUSED A SMALL BURN TO PT'S RIGHT LOWER LIP IN 2 PLACES. THE PHYSICIAN TREATED WITH POLYSPORIN AND DOES NOT EXPECT IT TO BE A PROBLEM.
INTRA-AORTIC BALLOON RUPTURED WHILE IN THE PT. BALLOON REMOVED. NO ADVERSE EVENT TO PATIENT AT TIME OF BALLOON RUPTURE OR POST-REMOVAL.
MALFUNCTIONING PORT. UNABLE TO ACCESS. DEVICE REMOVED AND REPLACED WITH ANOTHER PRODUCT. PORT WAS INSERTED AT ANOTHER FACILITY.
THE RESIDENT IS AN OBESE FEMALE WHO REQUIRES TRANSFERS FROM BED TO WHEELCHAIR AND VICE VERSA VIA A MECHANICAL LIFTER. WHILE BEING TRANSFERRED FROM HER BED TO THE WHEELCHAIR, THE HANDLE, WHICH MOVES THE LEGS APART, POPPED OUT OF ITS SLOT CLOSING THE LEGS OF THE LIFTER. THE LIFTER WAS UNABLE TO SUSTAIN HER WEIGHT RESULTING IN THE RESIDENT FALLING TO THE FLOOR AND FRACTURING HER HIP. THE RESIDENT WAS HOSPITALIZED FOR SEVEN DAYS.
DRILL DID NOT WORK PROPERLY DURING SURGERY FOR CERVICAL FUSION. SURGERY WAS CHANGED TO DISCECTOMY AND FUSION HAS BEEN RESCHEDULED.
PT COMPLAINING OF PAIN AT SITE. CONTRAST MEDIA PORT STUDY PERFORMED. RESULTS--"BROKEN LEFT-SIDED PORT." FLUOROSCOPIC REMOVAL OF BROKEN PORT FRAGMENT VIA RIGHT COMMON FEMORAL VEIN. PT TOLERATED PROCEDURE WELL.
PORT OCCLUDED. DURING REMOVAL IT WAS NOTED THAT THE CATHETER WAS BROKEN INTO TWO PIECES. ONE PIECE REMOVED. ONE REMAINED IN PT REQUIRING RADIOLOGY INTERVENTION. FRAGMENTED PIECE RETRIEVED VIA RIGHT FEMORAL ARTERY APPROACH.
ADMITTED WITH CONGESTIVE HEART FAILURE. UNDERWENT A CARDIAC CATHETERIZATION ON 1/8/96. THE INTRA-AORTIC BALLOON WAS INSERTED FOLLOWING THE PROCEDURE. BLOOD WAS NOTED IN THE LINE SHORTLY AFTER INSERTION. THE BALLOON WAS REMOVED AND A NEW ONE INSERTED. 0N 1/12/96 UNDERWENT QUADRUPLE BYPASS, MITRAL VALVE REPLACEMENT AND PLACEMENT OF TEMPORARY PACEMAKER WIRES.
MALFUNCTIONING PORT. CONTRAST MEDIA STUDIES SHOW LEAK MID-POINT OF CATHETER. PORT REMOVED AND NEW PORT IMPLANTED ON 7/13/95.
MALFUNCTIONING PORT. CHEST FLUOROSCOPY PERFORMED. FINDINGS SHOWED LEAKAGE FROM THE MORE PROXIMAL PORTION OF THE CATHETER AT THE AREA OF THE JUNCTION OF THE RIGHT SUBCLAVIAN VEIN. SUGGESTS PARTIAL TEAR OF THE CATHETER. ON 8/16/95 SURGICAL REMOVAL OF CATHETER. DURING REMOVAL CATHETER BROKE OFF. PORTABLE CHEST X-RAY DEMONSTRATES 13 CM LONG SEGMENT OF CATHETER IN THE SUPERIOR VENA CAVA AND RIGHT ATRIUM. AN INFERIOR VENOCAVOGRAM PERFORMED VIA RIGHT SUPERFICIAL FEMORAL VEIN. SUCCESSFUL REMOVAL OF 13CM LONG FRAGMENT OF CATHETER. PT TOLERATED PROCEDURE WELL.
DURING PTCA WITH STENT PLACEMENT PROCEDURE, GUIDEWIRE AND BALLOON HAS CROSSED LESION. WHEN ATTEMPTING TO REMOVE GUIDEWIRE BROKE INSIDE BALLOON CATHETER. CATHETER AND GUIDEWIRE REMOVED. PROCEDURE RESTARTED WITH SAME TYPE OF GUIDEWIRE. WHEN ATTEMPTING TO EXCHANGE GUIDEWIRE, TIP SEPARATED FROM MAIN GUIDEWIRE AND WAS UNABLE TO BE RETRIEVED.
STENT CATHETER BALLOON WOULD NOT INFLATE WHILE IN PT'S BODY. STENT AND CATHETER WERE REMOVED WITHOUT INCIDENT.
ACCESS PORT FOR CHEMOTHERAPY PLACED IN LEFT SUBCLAVIAN 6/19/95. PT RECEIVED NALVEDINE VIA PORT BIMONTHLY. IN 9/95, AFTER CHEST X-RAY SHOWED NO CHANGE IN POSITION OF CATHETER TIP, AND AFTER GOOD BLOOD RETURN, PT COMPLAINED OF PAIN AROUND THE TIME OF NALVEDINE ADMINISTRATION, DEMONSTRATED BREAST ERYTHEMA AND EXTRAVASATION PROTOCOL ACTIVATED. SURGICAL AND PLASTIC SPECIALTIES CONSULTED AND CATH REMOVED 9/19/95.
PT WAS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY. SURGEON HAD USED THIS MACHINE TO INFLATE ABDOMEN WITH CO2 GAS AND MACHINE HAD PERFORMED PROPERLY. SUDDENLY SURGEON REALIZED ABDOMEN DEFLATING AND MACHINE ELECTRONICS FLASHING ON AND OFF, ATTEMPTED TO RESTART MACHINE, ELECTRICAL CONNECTION CHECKED, OUTLET FUNCTIONING. SURGERY DELAYED WHILE ANOTHER MACHINE OBTAINED. SURGERY COMPLETED AND PT TO RECOVERY IN STABLE CONDITION. DISCHARGED HOME 12/23/95.
LEFT BREAST IMPLANT AND LATERAL DORSAL FLAP ON 1981 FOR POLAND'S SYNDROME LEFT CHEST. IMPLANT PLACED AT ANOTHER FACILITY . SURGERY ON 8/10/95 DUE TO RUPTURE ON SILICONE GEL IMPLANT.
HUBER NEEDLE DISCONNECTED FROM TAB. NEEDLE LODGED IN SKIN. DR WAS ABLE TO PROBE AT NEEDLE TO REMOVE. NO PT HARM.
PT FOUND WITH CATHETER LEAKING AT HUB. LINE HAD TO BE REPAIRED.
64 YEAR OLD WITH HISTORY OF PPM PLACEMENT APPROX 3 YEARS AGO, AND NOTED LIGHTHEADEDNESS AND PRESYNCOPE, WAS ADMITTED TO HOSP. ON 9/16/95 MFR CHECKED PACEMAKER FOR FAILURE TO FIRE. EKG SHOWED OVERSENSING AND FREQUENT FAILURE TO CAPTURE AT MAXIMUM OUTPUT. PT UNDERWENT RIGHT VENTRICLE LEAD REPLACEMENT ON 9/18/95.
UPON REVIEW OF THE RECORD AS PART OF THE RETROSPECTIVE QUALITY IMPROVEMENT REVIEWS IT WAS NOTED THAT THE PT WAS ADMITTED FOR A REPLACEMENT OF A MALFUNCTIONING PENILE PROSTHESIS. IN THE HISTORY IT WAS NOTED THAT THE PROSTHESIS HAD A MALFUNCTION OF THE PUMP ON THE RIGHT SINCE 6/95.
PT WAS ADMITTED FOR A RETAINED HIP SCREW WHICH WAS PAINFUL IN THE LEFT HIP. WHEN THE SURGEON REMOVED SCREW, HE NOTED THAT IT WAS DIFFICULT TO GET THE PLATE OFF OF THE LAG SCREW. IT WAS NOTED THAT THE LAG SCREW HAD RUST ON IT. THE SURGEON NOTED THE METAL DOES NOT APPEAR TO LOOK AS IT SHOULD AND REQUESTS DEVICE BE RETURNED TO THE SALES REPRESENTATIVE. THE IMPLANTS WERE SCRUBBED AND AUTOCLAVED SO THAT THEY COULD BE RETURNED.
A 95 YEAR OLD FEMALE WITH HISTORY OF PPM INSERTION IN 1979 WITH PULSE GENERATOR CHANGE IN 1985. PT ADMITTED WITH SYNCOPE AND BRACHYCARDIA. BATTERY CHANGE ON 10/31/95 DUE TO END OF LIFE. LEAD WIRE REMOVED AT THIS TIME DUE TO CHRONICALLY HIGH PACING THRESHOLDS CAUSING EXIT BLOCK.
PT ADMITTED FOR LAPAROSCOPIC CHOLECYSTECTOMY. WHILE CLOSING INCISION, NEEDLE BROKE APPROX IN HALF INTO SOFT TISSUE OF UPPER PORT SITE. UNABLE TO RETRIEVE.
PT WITH HISTORY OF PELVIC PAIN. LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PERFORMED. AFTER CLOSING SKIN INCISION, IT WAS NOTED THAT THE VERY TIP OF NEEDLE WAS MISSING.
A 91 YEAR OLD MALE ADMITTED WITH ALTERED MENTAL STATUS FOLLOWING MOTOR VEHICLE ACCIDENT. PT WITH COMPLICATIONS OF SYNCOPE/DIZZINESS. ON EVALUATION, FOUND LEAD TO HAVE INSULATION FAILURE. LEAD WAS REPLACED.
THE COMPLAINT STATES THAT ON 1/14/96 RPTR ALMOST HAD AN ACCIDENT WHILE DRIVING AT NIGHT DUE TO "CIRCULAR RAINBOWS" REFLECTING OFF THE ONCOMING CARS HEADLIGHTS. THE "RAINBOW" EFFECT WAS ONLY IN THE LEFT LENS AND ALSO OCCURS AT CERTAIN ANGLES WHILE IN THE SUNLIGHT. RPTR HAS WORN THESE LENSES BEFORE WITH NO PROBLEMS. SHE RETURNED THE LENS ON 1/17/96 AND WAS TOLD BY THE ATTENDING OPTOMETRIST THAT IT WAS A DEFECT BUT NO OTHER SIMILAR COMPLAINTS HAD BEEN RECEIVED. COMPLAINANT REQUESTS A F/U INVESTIGATION.
LEAKING LEFT BREAST IMPLANT WITH REPLACEMENT. FOUND TO BE INTACT UPON REMOVAL.
PT ADMITTED FOR ELECTIVE LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. TIP OF NEEDLE BROKE WHILE SUTURING SKIN. MAGNETIC RETRIEVER ATTEMPTED WITHOUT SUCCESS. ABDOMINAL X-RAYS TAKEN. NO RADIOPAQUE FOREIGN BODIES IDENTIFIED. 12/5/95 NEW REPORT FILED DUE TO INCORRECT REPORT # OF 610486447-1995-0011. NEW NUMBER 610486447-1995-0012.
RN IN NICU DEVELOPED LATEX HYPERSENSITIVITY CONFIRMED BY RAST TWO TIMES. PROGRESSED TO SYSTEMIC REACTIONS INCLUDING LATEX INDUCED ASTHMA. TIME FROM DIAGNOSIS TO DISABILITY WAS 12 MONTHS. UNABLE TO RETURN TO WORK AS RN IN HOSP OR OFFICE WHERE LATEX IS PRESENT.
PT ASPIRATED TUBE FEEDINGS. IT APPEARS THAT DURING REMOVAL OF FACE MASK, THE FEEDING TUBE WAS PULLED BACK WHILE TUBE FEEDING WAS INFUSED. THE FEEDING TUBE DISLODGED. TUBE FEED MATERIAL SUCTIONED FROM LUNGS. ASPIRATION TO DETERMINE PLACEMENT OF TUBE INEFFECTIVE DUE TO SMALL TUBE SIZE (THE TUBE COLLAPSES). A PH INDICATOR BUILT INTO THE TUBE WOULD BE HELPFUL.
QUEST MEDICAL, INC. ONE ALLENTOWN PKWY, ALLEN, TX 75002-4211. THIS LETTER IS IN REGARD TO MDR ACCESS NUMBER 1008469, WHICH WAS VOLUNTARILY REPORTED FROM AN ANONYMOUS SOURCE. WE WERE REQUIRED TO EVALUATE THE REPORTED INFO AND DETERMINE WHETHER THE EVENT IS REPORTABLE UNDER THE MDR REQUIREMENTS. AFTER REVIEWING THE MEDWATCH REPORT WE DETERMINED THAT THIS INCIDENT IS NOT REPORTABLE. OUR DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PT GOING INTO RESPIRATORY DEPRESSION FROM MORPHINE. ATTACHED IS A COPY OF THE REPORT.
PT GOT BREAST IMPLANTS FOR COSMETIC REASONS. HER IMPLANTS WERE REPLACED 1 TIME. UPON REMOVAL ONE IMPLANT WAS FOUND TO BE RUPTURED AND BLEEDING THROUGH ENVELOPE. SHE HAS HAD 2 CAPSULAR CONTRACTURES AND 1 CLOSED CAPSULOTOMY. PT C/O NUMBNESS AND MULTIPLE SCLEROSIS-LIKE SYMPTOMS. SHE TESTS NEGATIVE FOR CONNECTIVE TISSUE DISEASE BUT HAS ALL THE ASSOCIATED SYMPTOMS. SHE TESTS NEGATIVE FOR RAYNAUD'S BUT SHE ALSO C/O CALCIUM DEPOSITS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, CARPAL TUNNEL SYNDROME, MOTOR NEURON DISEASE, ANXIETY &/OR DEPRESSION. ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, CONFUSION, BALANCE DISTURBANCES, DIFFUSE BRAIN ATROPHY, PAIN, CHRONIC SWELLING, PAIN AND SENSITIVITY OF EXTREMITIES, ESOPHAGITIS, IRRITABLE BOWEL SYNDROME, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS. IRREGULAR HEART BEAT, ALLERGIES TO CHEMICALS, DUST, AUTOIMMUNE REACTION, ARTHRALIGA, PERSISTENT JOINT STIFFNESS, PAIN IN LIVER, TROUBLE BREATHING, LYMPHADENOPATHY, MUSCLE SPASMS, MUSCLE PAIN & BURNING, FIBROMYALIGA, MYOSITIS, RASHES, SUN SENSITIVITY, SEVERE ITCHING, CHRONIC INSOMNIA, THORACIC OUTLET SYNDROME AND CHRONIC FATIGUE SYNDROME. PT COMMITTED SUICIDE DUE TO SYMPTOMS. (ALSO SEE 1008471)
PT GOT BREAST IMPLANTS FOR COSMETIC REASONS. SHE ALSO HAD CHIN IMPLANTS. HER IMPLANTS WERE REPLACED 1 TIME. UPON REMOVAL ONE IMPLANT WAS FOUND TO BE RUPTURED AND BLEEDING THROUGH ENVELOPE. SHE HAS HAD 2 CAPSULAR CONTRACTURES AND 1 CLOSED CAPSULOTOMY. PT C/O NUMBNESS AND MULTIPLE SCLEROSIS-LIKE SYMPTOMS. SHE TESTS NEGATIVE FOR CONNECTIVE TISSUE DISEASE BUT HAS ALL THE ASSOCIATED SYMPTOMS. SHE TESTS NEGATIVE FOR RAYNAUD'S BUT SHE ALSO C/O CALCIUM DEPOSITS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, CARPAL TUNNEL SYNDROME, MOTOR NEURON DISEASE, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, CONFUSION, BALANCE DISTURBANCES, DIFFUSE BRAIN ATROPHY, PAIN, CHRONIC SWELLING, PAIN AND SENSITIVITY OF EXTREMITIES, ESOPHAGITIS, IRRITABLE BOWEL SYNDROME, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, IRREGULAR HEART BEAT, ALLERGIES TO CHEMICALS, DUST, AUTOIMMUNE REACTION, ARTHRALIGA, PERSISTENT JOINT STIFFNESS, PAIN IN LIVER, TROUBLE BREATHING, LYMPHADENOPATHY, MUSCLE SPASMS, MUSCLE PAIN & BURNING, FIBROMYALIGA, MYOSITIS, RASHES, SUN SENSITIVITY, SEVERE ITCHING, CHRONIC INSOMNIA, THORACIC OUTLET SYNDROME AND CHRONIC FATIGUE SYNDROME, PT COMMITTED SUICIDE DUE TO SYMPTOMS. (ALSO SEE 1008470)
DURING SURGERY, THE TIP OF THE PERIOSTAL ELEVATOR BROKE OFF. X-RAY REVEALED TIP IN THE OPEN WOUND. TIP WAS REMOVED PRIOR TO CLOSURE. NO ADVERSE OUTCOMES DUE TO THIS EVENT WERE OBSERVED BY THE PT'S PHYSICIAN.
BALLOON RUPTURED DURING INFLATION IN CORONARY STENT CAUSING PROFOUND HYPOTENSION. PT TRANSFERRED TO ICU FOR ONE DAY STAY.
ON WITHDRAWAL OF THE GUIDEWIRE FROM A 12 FR BILUMEN CVP IT WAS FOUND TO BE "UNRAVELED". A CHEST X-RAY WAS TAKEN IN THE O.R. WHICH REVEALED 2 CM OF GUIDE WIRE IN THE LEFT NECK, A SMALL (-2 CM) SURGICAL INCISION WAS MADE AND THE GUIDEWIRE WAS RETRIEVED WITHOUT DIFFICULTY. NO APPARENT ADVERSE  CONSEQUENCE (OTHER THAN THE NECESSITY FOR SURGICAL REMOVAL OF THE RETAINED WIRE) WAS NOTED.
A 2 CM. BURN TO LEFT LATERAL THIGH SUSTAINED FROM ELECTROSURGERY UNIT PAD.
A 1/2 CM. BURN TO LEFT ANTERIOR THIGH AT RETURN ELECTRODE SITE NOTED. CORD FAULT ALARM HAD ACTIVATED. PAD WAS DISCONTINUED.
BALLOON WAS IN THE LAD BURST AT 18 BARS ON SECOND INFLATION. UNABLE TO  BRING BACK THROUGH GUIDING CATHETER. BALLOON, GUIDE WIRE, GUIDE CATHETER BROUGHT BACK AS ONE UNIT. ATTACHED TO TIP OF BALLOON CATHETER WAS TISSUE SENT TO PATHOLOGY FOR IDENTIFICATION.
PT HAD COMPLAINTS OF INTRACTABLE FACIAL PAIN AND MANDIBULAR ANKLYSOSIS. THE PT IS STATUS POST 3 LEFT TMJ SURGERIES SINCE 1991. A LEFT TMJ ARTHROPLASTY, REMOVAL OF GLENOID FOSSA IMPLANT WAS COMPLETED. THE PROSTHESIS WAS NOTED TO BE MOBILE WITH LOOSENING OF SCREWS.
TUBE FEEDING CONNECTED TO TRACH TUBE RED WING PILOT PORT INSTEAD OF RED   TUBE FEED PORT.
TUBE FEEDING CONNECTED TO TRACH TUBE RED WING PILOT PORT INSTEAD OF TUBE FEED PORT.
IMPLANTS RECEIVED FOLLOWING MASTECTOMY FOR FIBROCYSTIC BREAST DISEASE WITH BEGINNING CANCER. PT HAS HAD IMPLANTS REPLACED 4 TIMES. SILICONE HAS BEEN CONFIRMED IN THE LIVER AND CALCIUM DEPOSITS HAVE OCCURRED. PT HAS HAD SEVERAL CAPSULAR CONTRACTURES WITH CLOSED CAPSULOTOMIES AND ONE OPEN CAPSULOTOMY. SHE HAS HAD EXCESS FLUID, NUMBNESS AND HEMATOMA OF THE BREAST. RPTR ALSO C/O: BLOOD PRESSURE PROBLEMS, CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION,  SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES, REDUCED BLOOD FLOW TO BRAIN, PAIN AND/OR BURNING SENSATION AND INFLAMMATION OF CHEST, RAPID DETERIORATION OF EYES, HASHIMOTO'S THYROIDITIS, CHRONIC SWELLING, PAIN, DISCOLORATION AND SENSITIVITY OF EXTREMITIES, RAYNAUD'S DISEASE, LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME, INFERTILITY DUE TO ENDOMETRIOSIS, OVARIAN PROBLEMS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, HEADACHES, ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, STAPH INFECTION IN RIGHT BREAST, CONNECTIVE TISSUE DISEASE, LUPUS, SJOGREN'S SYNDROME, ARTHRALGIA, RHEUMATOID ARTHRITIS, ASTHMA, PLEURISY, LYMPHADENOPATHY, MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, RASHES, SUN SENSITIVITY, SEVERE ITCHING, CHRONIC INSOMNIA, CHRONIC FATIGUE SYNDROME, GRANULOMAS AND CLUMSINESS. BIOPSY SHOWED DENSE FIBROSIS WITH HISTIOCYTIC PROLIFERATION AND FOREIGN BODY REACTION. NO SIGNIFICANT PATHOLOGIC ALTERATIONS IN NIPPLE AND SKIN. (ALSO SEE 1008473 - 1008475)
PT HAS HAD SEVERAL CAPSULAR CONTRACTURES WITH CLOSED CAPSULOTOMIES AND ONE OPEN CAPSULOTOMY. SHE ALSO HAS RIGHT BREAST NUMBNESS. RPTR ALSO C/O: BLOOD PRESSURE PROBLEMS, CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION,  SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES, REDUCED BLOOD FLOW TO BRAIN, PAIN AND/OR BURNING SENSATION AND INFLAMMATION OF CHEST, RAPID DETERIORATION OF EYES, HASHIMOTO'S THYROIDITIS, CHRONIC SWELLING, PAIN, DISCOLORATION AND SENSITIVITY OF EXTREMITIES, RAYNAUD'S DISEASE, LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME, INFERTILITY DUE TO ENDOMETRIOSIS, OVARIAN PROBLEMS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, HEADACHES, ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, STAPH INFECTION IN RIGHT BREAST, CONNECTIVE TISSUE DISEASE, LUPUS, SJOGREN'S SYNDROME, ARTHRALGIA, RHEUMATOID ARTHRITIS, ASTHMA, PLEURISY, LYMPHADENOPATHY, MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, RASHES, SUN SENSITIVITY, SEVERE ITCHING, CHRONIC INSOMNIA, CHRONIC FATIGUE SYNDROME, GRANULOMAS AND CLUMSINESS. BIOPSY SHOWED DENSE FIBROSIS WITH HISTIOCYTIC PROLIFERATION AND FOREIGN BODY REACTION. NO SIGNIFICANT PATHOLOGIC ALTERATIONS IN NIPPLE AND SKIN. (ALSO SEE 1008472, 1008474 AND 1008475.)
PACER AND LEADS IMPLANTED 8/7/95. PT PRESENTED WITH CHF. DURING ADMISSION DEVICE WAS NOTED TO HAVE PROBLEMS SENSING AND CAPTURING ON THE VENTRICULAR CHANNEL. TRANSFERRED TO THIS FACILITY ON 10/9/95 FOR EVALUATION. THERE WAS A QUESTION OF CHEST WALL STIMULATION AND MALFUNCTION WITH ARM MOVEMENT. PT OBSERVED, PACER TESTED AND FOUND TO HAVE INTERMITTENT SENSING AND CAPTURING ON 10/10/95. PT REQUIRED REPLACEMENT OF VENTRICULAR LEAD AND REPOSITIONING OF ATRIAL LEAD ON 10/12/95. VENTRICULAR LEAD REMOVED DUE TO MALFUNCTION AND QUESTIONABLE FRACTURE.
PT HAD RUPTURED ECTOPIC PREGNANCY REQUIRING EXPLORATORY LAPAROTOMY AND LEFT SALPINGOOPHERECTOMY. A DRAIN WAS INSERTED DURING SURGERY. WHEN THE DRAIN WAS REMOVED, IT BROKE INTO TWO PARTS. SURGERY WAS PERFORMED ON 10/24/95 TO REMOVE THE PART THAT REMAINED FLOATING IN THE PERITONEUM.
PT HAS HAD SEVERAL CAPSULAR CONTRACTURES WITH CLOSED CAPSULOTOMIES AND ONE OPEN CAPSULOTOMY. SHE HAS BREAST NUMBNESS AND BLEEDING THROUGH THE ENVELOPE. RPTR ALSO C/O: BLOOD PRESSURE PROBLEMS, CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION,  SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES, REDUCED BLOOD FLOW TO BRAIN, PAIN AND/OR BURNING SENSATION AND INFLAMMATION OF CHEST, RAPID DETERIORATION OF EYES, HASHIMOTO'S THYROIDITIS, CHRONIC SWELLING, PAIN, DISCOLORATION AND SENSITIVITY OF EXTREMITIES, RAYNAUD'S DISEASE, LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME, INFERTILITY DUE TO ENDOMETRIOSIS, OVARIAN PROBLEMS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, HEADACHES, ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, STAPH INFECTION IN RIGHT BREAST, CONNECTIVE TISSUE DISEASE, LUPUS, SJOGREN'S SYNDROME, ARTHRALGIA, RHEUMATOID ARTHRITIS, ASTHMA, PLEURISY, LYMPHADENOPATHY, MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, RASHES, SUN SENSITIVITY, SEVERE ITCHING, CHRONIC INSOMNIA, CHRONIC FATIGUE SYNDROME, GRANULOMAS AND CLUMSINESS. BIOPSY SHOWED DENSE FIBROSIS WITH HISTIOCYTIC PROLIFERATION AND FOREIGN BODY REACTION. NO SIGNIFICANT PATHOLOGIC ALTERATIONS IN NIPPLE AND SKIN. (ALSO SEE 1008472, 1004873 AND 1004875.)
PT REPORTS SIGNIFICANT REACTION FOLLOWING THE INSERTION OF CONTACT LENSES WHILE AT SCHOOL, WHICH CREATED A SERIES OF EVENTS FOR THIS PT.  BECAUSE OF THE DEGREE OF BURNING SENSATION WHICH DEVELOPED FOLLOWING INSERTION OF THE CONTACT LENSES, THE PT'S MOTHER BROUGHT THE PT TO A FAMILY CLINIC WHERE MEDICATION WAS PRESCRIBED LIVOSTON QID.  THE MEDICATION REPORTEDLY DID NOT SOOTHE THE EYE AND THE PT COULD NOT TOLERATE LIGHT.  THE EVENT OCCURRED ON A FRIDAY AND THE PT REMAINED INDOORS, IN THE DARK, THROUGH MONDAY WHEN THE EYES WERE STILL AGITATED.  RPTR'S OPHTHALMOLOGIST SAW THE PT AND PRESCRIBED TOBRADEX AND THE PARENT SOUGHT A SECOND OPINION FROM ANOTHER OPHTHALMOLOGIST WITH DIAGNOSIS RANGING FROM "CHEMICAL BURN REACTION" TO "CORNEAL ABRASION".  PT HAS HAD CONTACTS IN THE PAST WHICH DID NOT CREATE A PROBLEM, AND HAS SINCE GONE BACK INTO CONTACTS, WHICH AGAIN ARE NOT CAUSING A PROBLEM.  THE PARENTS ARE LOOKING AT THIS AS A SIGNIFICANT EVENT FOR THE CHILD. THE REMAINING CUBES WERE RETURNED TO THE PHYSICIAN. EXP DATE LEFT LENS 10/98.
DIALYSIS PT. AIR IN BLOOD DETECTOR, DID NOT ALARM EVENT THOUGH BLOOD HAD VISIBLE AIR BUBBLES. CO CHECKED THE UNIT ON 11/1/95. THE TECHNICIAN COULD NOT DUPLICATE THE PROBLEM. THE UABD TRANSDUCERS WERE REPLACED AS A PRECAUTION.
PT DEVELOPED INFECTION, HEMATOMA, AND NUMBNESS OF RIGHT BREAST AND NUMBNESS OF LEFT. RIGHT IMPLANT WAS BLEEDING THROUGH THE ENVELOPE AND LEFT RUPTURED. RPTR ALSO C/O: BLOOD PRESSURE PROBLEMS, CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION,  SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES, REDUCED BLOOD FLOW TO BRAIN, PAIN AND/OR BURNING SENSATION AND INFLAMMATION OF CHEST, RAPID DETERIORATION OF EYES, HASHIMOTO'S THYROIDITIS, CHRONIC SWELLING, PAIN, DISCOLORATION AND SENSITIVITY OF EXTREMITIES, RAYNAUD'S DISEASE, LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME, INFERTILITY DUE TO ENDOMETRIOSIS, OVARIAN PROBLEMS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, HEADACHES, ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, STAPH INFECTION IN RIGHT BREAST, CONNECTIVE TISSUE DISEASE, LUPUS, SJOGREN'S SYNDROME, ARTHRALGIA, RHEUMATOID ARTHRITIS, ASTHMA, PLEURISY, LYMPHADENOPATHY, MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, RASHES, SUN SENSITIVITY, SEVERE ITCHING, CHRONIC INSOMNIA, CHRONIC FATIGUE SYNDROME, GRANULOMAS AND CLUMSINESS. BIOPSY SHOWED DENSE FIBROSIS WITH HISTIOCYTIC PROLIFERATION AND FOREIGN BODY REACTION. NO SIGNIFICANT PATHOLOGIC ALTERATIONS IN NIPPLE AND SKIN. ALSO SEE 1008472 - 1008474.)
IN 1985 PT HAD MASTECTOMY AND BREAST RECONSTRUCTION. IN 8/23/95 SHE HAD EXPLORATION OF LEFT BREAST, REMOVAL OF RUPTURED IMPLANT AND TOTAL FIBROUS CAPSULE.
MALFUNCTION OF CERVICAL EPIDURAL SPINAL STIMULATOR WITH TOTAL FRACTURE OF EXTENSION LEAD. IMPLANTED 2/2/95. SURGICAL REVISION OF EPIDURAL SPINAL STIMULATOR ON 9/14/95 WITH REPLACEMENT OF FRACTURED EXTENSION LEAD.
ON 10/2/95 PT HAD 3 FR PICC CATHETER INSERTED RIGHT ARM PRIOR TO DISCHARGE FOR ADMINISTRATION OF ANTIBIOTICS. ON 12/5/95 PT CAME TO ER TO HAVE CATHETER CHECKED DUE TO LEAKING AT INSERTION SITE AND REPAIR SITE. DUE TO PREVIOUS LEAKING DECISION, WAS MADE TO REMOVE CATHETER FROM RIGHT ARM. DIFFICULTY EXPERIENCED WITH REMOVAL. CATHETER BROKE AT INSERTION SITE. APPROX 10-12 INCHES OF CATHETER REMAINED IN RIGHT UPPER ARM. CUT DOWN IN RIGHT BASILIC VEIN DONE AND PICC CATHETER REMOVED INTACT. (2 SECTIONS)
ROUTINE DEFIBRILLATOR CHECKS IN THE OFFICE. A LETTER FROM THE COMPANY, AFTER A RESETTING OF THE PT'S SHOCK COUNTS, WAS RECEIVED IN WHICH THE RECOMMENDATION WAS TO CHANGE THE PT'S GENERATOR AS THIS WAS A GENERATOR MALFUNCTION. ON 11/2/95 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR GENERATOR CHANGE AND RE-COUMADINIZATION.
PROCEDURE PTCA OF RIGHT CORONARY ARTERY WITH STENT INSERTION. STENT NOT DEPLOYED, BUT MISSING FROM BALLOON WHERE BALLOON WAS REMOVED FROM GUIDE. UNEXPANDED STENT LODGED IN SMALL PROXIMAL RCA. STENT LENGTH 15MM.
LEFT VENTRICULAR ASSIST DEVICE EMPTYING POORLY. EMPTYING CONTINUED TO DECREASE. REPLACED WITH BACK-UP PUMP. COMPANY SERVICE REP CONTACTED AND PUMP REPAIRED.
ON 8/29/95 BILIARY STENT WAS INSERTED. ON 9/7/95 KUB DEMONSTRATED INTACT BILIARY STENT. ON 1/29/96 KUB DEMONSTRATED BILIARY STENT UNRAVELING AT DISTAL END.
PROGRAMMABLE PUMP NEEDED TO BE EXPLANTED AS IT WAS NOT WORKING. NO PATIENT INJURY.
PT WAS INTUBATED AND NOT VENTILATING EFFECTIVELY. IT WAS NOTICED THAT THE UNDERSIDE OF THE CONNECTOR OF THE ET TUBE WAS CRACKED. PT WAS IMMEDIATELY EXTUBATED AND RE-INTUBATED; ADEQUATE VENTILATION RE-ESTABLISHED.
TROCAR DID NOT RETRACT PROPERLY. NO PATIENT INJURY, JUST HAD TO USE A NEW ONE.
STAPLER MISFIRED DURING SURGERY AND THE SECOND STAPLER ALSO MISFIRED. NO HARM TO PATIENT.
PT EXPERIENCED RESPIRATORY ARREST FOLLOWING APPROX 40CC OVERINFUSION OF DEMERAL. HISTORY STORED IN PUMP INDICATED ONLY TWO DOSES DELIVERED: 1. INITIAL BOLUS. 2. ONE DOSE ADMINISTERED BY PT. MIXTURE WITHIN SYRINGE INDICATED APPROX 40CC LESS THAN DATA STORED IN PUMP HISTORY. SUSPECT POSSIBLE FREE FLOW OCCURRENCE DUE TO THE FACT THAT SYRINGE PLUNGER HAD NOT DESCENDED. NURSE STATED THERE WAS A LARGE AIR BUBBLE BETWEEN THE MIXTURE AND PLUNGER. NURSE ALSO INDICATED THAT THE PUMP DOOR WAS LOCKED DURING THIS TIME.
IV MED WOULD NOT FLOW THROUGH THE SPIKE. NO HOLE FOR FLOW.
CONFUSED PATIENT HAD HEAD BETWEEN SIDE RAIL AND BED. NO INJURY.
PT WITH HEAD INJURY IN REHABILITATION UNIT WAS FOUND ON FLOOR. NURSES STATE THAT DEVICE DID NOT ALARM.
DURING ERCP, THE SHEATH STARTED TO MELT. THERE WAS NO CONDUCTION OF ELECTRICITY TO THE SNARE. THE POLYPECTOMY SNARE ASSEMBLY EQUIPMENT WAS REMOVED AND REPLACED.
BREAST IMPLANT RUPTURE WAS DIAGNOSED BY PHYSICIAN. IT EVIDENTLY HAD BEEN RUPTURED AT LEAST 2 YEARS PRIOR TO DIAGNOSIS. MRI FILMS HAD BEEN READ BUT MISDIAGNOSED.
PT HAD ROUTINE PACEMAKER ANALYSIS AND NOTED TO HAVE VERY LOW IMPEDANCE ON VENTRICULAR LEAD. PACEMAKER LEAD WAS UNDER ADVISORY FROM THE MFR. PT ADMITTED FOR REPLACEMENT OF THE VENTRICULAR LEAD, LEAD WAS CHECKED AND  FOUND TO BE DEFECTIVE.
RPTR WAS OPERATED ON TO CORRECT GRADE II SPONDYLOLISTHESIS AND DESTROYED DISCS FROM L-5 THROUGH S-1, COMMONLY KNOWN AS 3-LEVEL 360 FUSION. HE HAD NON-APPROVED HARDWARE PUT IN (PLATES AND PEDICLE SCREWS). HE WAS TOLD TO GO BACK TO WORK. DURING WORK, A PEDICLE SCREW BROKE AND TOTALLY INCAPACITATED RPTR FOR OVER ONE WEEK. TO DATE HE IS IN EXCRUCIATING PAIN AND FAILURE (PERIODICALLY) OF RIGHT LEG TO FUNCTION PROPERLY. DURING RECOVERY FROM THE OPERATION, RPTR CONTRACTED A PSEUDOMONAS INFECTION IN HIS URINARY SYSTEM DUE TO UNSANITARY CATHETER CLEANING. RESULTS WERE NEAR-FATAL AND HE REQUIRED KIDNEY RECONSTRUCTION. AT THAT TIME (1991 - 12/92) IT WAS DISCOVERED THAT HE POSSESSED ONLY ONE KIDNEY; THE SERIOUSLY DAMAGED ONE.
THIS MACHINE IS SUPPOSED TO CLEAR CHLORINE AND CHLORAMINE FROM WATER BUT IT ONLY CLEARS CHLORINE. THE CARBON FILTER DOES NOT HAVE THE CAPACITY TO CLEAR THE CHLORAMINE. WHEN THE TECH NOTICED THE PROBLEM HE CALLED THE MFR AND THE CARBON FILTER WAS REPLACED.
ON 7/19/95, PT WAS ADMITTED FOR EVACUATION OF HEMATOMA, LEFT RECONSTRUCTED BREAST FOLLOWING A SUBCUTANEOUS MASTECTOMY APPROX 1 YR. AGO & A PERIPROSTHETIC CAPSULOTOMY DONE APPROX. 36 HOURS PRIOR TO ADMISSION. THE PROSTHETIC IMPLANT WAS TEMPORARILY REMOVED DUE TO BLOOD CLOTS WITHIN THE IMPLANT. THE SURGEON BELIEVES THE VALVE ON THE IMPLANT IS DEFECTIVE.
PT UNDERWENT BILATERAL AUGMENTATION MAMMOPLASTY WITH LEFT MASTOPEXY PERFORMED 1/6/87. SHE HAD A XEROMAMMOGRAM PERFORMED 9/8/92 THAT SHOWED LEFT IMPLANT FAILURE WITH MATERIAL INTO THE AXILLA. SHE UNDERWENT BIOPSY ON ?/8/95 WHICH RETURNED BREAST PARENCHYMA WITH SILICONE MATERIAL. ON 12/5/95 SHE UNDERWENT REMOVAL OF BREAST IMPLANT AND IMPLANT MATERIAL RUPTURE  EXTENDING PAST THE CAPSULE MARKEDLY INFILTRATING SURROUNDING TISSUE ON THE LEFT. SHE ALSO HAD THE RIGHT INTACT IMPLANT REMOVED WITH TOTAL CAPSULECTOMY.
DURING CHOLECYSTECTOMY AND ADHESION LYSING, PT SUFFERED A BURN TO HER SUBCUTANEOUS TISSUE. IT WAS NOTED THAT THE INSULATION ON LAPAROSCOPIC FORCEPS HAD MELTED IN SEVERAL PLACES. THE BURNED TISSUE WAS REMOVED AND THE PT SUFFERED NO FURTHER PROBLEMS.
LEAD SURGICALLY REMOVED DUE TO FRACTURE.
UMBILICAL CATHETER BROKE IN HALF WHILE BEING PULLED. NURSE AND NURSE PRACTITIONER WERE ABLE TO PULL THE REST OF THE CATHETER INTACT WITH MINIMAL BLEEDING. NO INJURY TO INFANT.
FAILURE OF PENILE PROSTHESIS (WORN OUT).
CASSETTE FAILED IN THE MIDDLE OF A CASE CAUSING INTRAOCULAR HEMORRHAGE ON A PT TAKING COUMADIN.
DISPOSABLE FORCEPS USED TO BIOPSY TISSUE DURING BRONCHOSCOPY WAS FOUND TO BE BROKEN WHEN REMOVED FROM SCOPE. PIECE MISSING WAS ABOUT 1 MM. IN SIZE. UNABLE TO LOCATE. NO APPARENT PROBLEM WITH PT. LIMITED CT OF LUNG NEGATIVE.
STITCHING ON MESH SEAT BELT HOLDING BUCKLE CAME OUT PRIOR TO THIS INCIDENT. THEREFORE, WHEN RESIDENT IN TRANSFER CHAIR LEANED FORWARD WITH FULL WEIGHT, PRESSURE CAUSED BELT END SLIDE OUT OF BUCKLE AND MADE SAFETY BELT USELESS. RESIDENT FELL TO FLOOR, FRACTURING HIP.
LINE TORN DURING REMOVAL. CONCERN FOR EMBOLIC PHENOMENON. PT NEEDED EMERGENT OR EXPLORATION AND REMOVAL OF LA TIP. THE SEGMENT OF LA LINE WAS FOUND LYING NEXT TO THE LEFT ATRIUM IN THE PERICARDIAL CAVITY. THE TIP WAS GIVEN TO THE MFR.
WHILE MANEUVERING TABLE WITH HAND BENEATH THE EDGE, 4TH AND 5TH FINGERS OF LEFT HAND WERE CAUGHT BETWEEN SLIDING & FIXED PORTIONS OF TABLE. NO FRACTURE OCCURRED. HOWEVER, 3 MONTHS AFTER THE INCIDENT, NUMBNESS IN FINGERS CONTINUES.
LEAD INITIALLY REPORTED AS FRACTURED WHEN VIEWED FLUOROSCOPICALLY. WAS  CONFIRMED AS FRACTURED ON EXPLANT TODAY. A SINGLE FRACTURE IS LOCATED NEAR THE LEAD TIP, BUT NOT AT THE WELDED JUNCTION OF "J-WIRE" AND ANODE. EASY EXPLANT AND PT IS DOING WELL.
PT HAS BEEN FOLLOWED SINCE 1/95 FOR POSSIBLE ATRIAL LEAD FRACTURE. FILMS OF 1/95 AND 5/95 READ AS NEGATIVE FOR LEAD FRACTURE. MICROSCOPIC EXAMINATION  AT THE TIME OF EXPLANT FOR REASONS OF ANXIETY SHOW A FRACTURE OF THE LEAD WITH PROTRUSION OF THE "J" WIRE APPROX 1 CM FROM THE ANODE. PT HAS A LARGE BODY HABITUS (6', 320 LB.) AND LEAD MOTION COULD NOT BE COMPLETELY STOPPED. PT PRESENTLY BEING TREATED FOR POSSIBLE PULMONARY EMBOLUS OCCURRING WITHIN 12 HOURS OF EXPLANT.
ATRIAL PACER LEAD EXPLANTED ON 9/12/95. FRACTURE SUSPECTED ON FLUOROSCOPY DONE ON 8/15/95, AND CONFIRMED ON MICROSCOPIC EXAMINATION TODAY. A SINGLE FRACTURE IS LOCATED APPROX 0.6 CM FROM THE WELD OF THE WIRE TO THE ANODE. SOME FIBROSIS WAS FOUND AT THE LEAD TIP DURING REMOVAL, AND THIS WAS OVERCOME WITH GENTLE DIRECT TRACTION. THE LEAD WAS REMOVED WITHOUT FURTHER COMPLICATIONS, AND THE PT WAS DISCHARGED TO HOME TODAY.
THE TIP OF THE SCISSORS BROKE OFF DURING SURGERY. IT WAS FOUND AND EXTRACTED FROM THE PT.
FRACTURE OF THE ATRIAL J-WIRE PORTION OF THE PACEMAKER LEAD WAS DIAGNOSED ON 2/2/95 WITH THE USE OF DIGITALLY INHANCED FLUOROSCOPY. ALTHOUGH THE PT WAS INFORMED OF THE FRACTURE ON 2/2, HE AVOIDED HAVING ANY PROCEDURE PERFORMED FOR SEVERAL MONTHS. THE PT WAS FINALLY CONVINCED TO HAVE THE LEAD REMOVED IN MID-SEPTEMBER. UNFORTUNATELY, THE FRACTURED J-WIRE HAD NOW PERFORATED, BUT JUST BARELY, AND THE J-WIRE HAD A DISTINCT "HUMP" AT THE ANODE, BUT WAS NOT FRACTURED THERE.
ATRIAL PACER LEAD WAS ORIGINALLY DIAGNOSED AS POTENTIALLY FRACTURED ON 9/13/95. UPON EXTRACTION YESTERDAY, IT WAS DETERMINED VIA MICROSCOPIC EXAMINATION THAT THE LEAD WAS NOT FRACTURED. THE AREA OF THE SUSPECTED FRACTURE WAS AT THE ANODE. ANOTHER FRACTURE WAS SUSPECTED APPROX 3 CM FURTHER ALONG THE LEAD, BUT THIS WAS ACTUALLY WHERE THE J-WIRE BEGAN TO WRAP AROUND THE ELECTRODE WIRES. LEAD WAS EXTRACTED WITHOUT COMPLICATIONS.
STENT WAS ORIGINALLY PLACED ON 6/25/92. UNFORTUNATELY, THE PT LEFT THE STATE AND WAS SUBSEQUENTLY LOST TO FOLLOW-UP UNTIL 9/95. THE STENT WAS FOUND TO HAVE FRACTURED INTO FOUR FRAGMENTS. THE FRAGMENT IN THE BLADDER WAS REMOVED. THE OTHER THREE FRAGMENTS REMAIN IN THE PT AS OF THIS DATE.
PT UNDERWENT AORTIC VALVE REPLACEMENT WITH DEVICE AND CABG X3 ON 11/7/95. RETURNED TO SURGERY ON 11/7/95 DUE TO CARDIOGENIC SHOCK AND CARDIAC ARREST FOR CABG X1, PACEMAKER WIRE PLACEMENT AND REPLACEMENT OF IABP. THE PT CONTINUED TO DO POORLY WITH ECHOCARDIOGRAMS X3 SHOWING NOTHING DEFINITIVE. ANGIOGRAM ON 11/8/95 REVEALED ONLY ONE LEAFLET OF THE PROSTHETIC VALVE. THE PT RETURNED TO SURGERY ON 11/8/95 BUT COULD NOT COME OFF BYPASS AND EXPIRED 11/9/95.
DURING A LAPAROSCOPIC SPLENECTOMY, THE DEVICE WAS PASSED FROM THE CIRCULATING NURSE TO THE SCRUB NURSE TO THE PHYSICIAN, AND WAS DIRECTLY APPLIED TO THE PT. WHEN DEVICE WAS OPENED TO RETRACT, IT DID NOT WORK. UPON REMOVAL, IT WAS NOTED THAT THE PIN AT THE BASE OF THE FAN SEGMENTS WAS MISSING. IT IS UNCLEAR IF THE PIN WAS MISSING PRIOR TO USE ON THE PT OR IF IT REMAINS IN THE PT.
THREE MONTH PREMATURE INFANT ADMITTED FOR PYLOROMYOTOMY DUE TO HISTORY OF PYLORIC STENOSIS. DURING INITIAL ANESTHESIA THE CIRCUIT VALVE (POP-OFF OR PRESSURE RELIEF VALVE) MALFUNCTIONED AND WAS UNABLE TO BE CORRECTED. THIS REQUIRED THE INFANT TO REQUIRE IV ANESTHESIA. THE CHILD REQUIRED EXTENDED INTUBATION DUE TO DELAY IN BODY EXCRETING IV AGENTS. INFANT WEIGHT 6-8 1/2 OZ.
DIGITALLY ENHANCED FLUOROSCOPY INDICATES 2 FRACTURES OF THE INTERNAL J-WIRE: ONE BETWEEN THE ANODE AND CATHODE, AND A SECOND APPROX 2 CM FROM THE ANODE IN THE DIRECTION OF THE PULSE GENERATOR. NO DECISION HAS YET BEEN REACHED REGARDING LEAD EXTRACTION.
ARTERIAL LINE BROKE DURING REMOVAL. EDGES WERE JAGGED AND REMAINING PORTION OF CATHETER IN VESSEL. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE PORTION OF THE CATHETER.
CATHETER HAD BEEN INSERTED APPROXIMATELY 6/95 FOR HA AND LIPIDS. PO FEEDINGS HAD BEEN STARTED AND DURING FEEDING INFANT BEGAN TO VOMIT. CATHETER TUBING PULLED WHILE POSITIONING INFANT UPRIGHT AND TUBING SNAPPED AND BROKE COMPLETELY. CATHETER CLAMPED BUT EVENTUALLY REMOVED. BLOOD WAS MINIMAL.
FRACTURED CATHETER REQUIRING TWO INVASIVE PROCEDURES FOR REMOVAL: 1) EXCISION OF RESERVOIR OF CENTRAL CATHETER; AND 2) FLUORO-RETRIEVAL OF INTRAVASCULAR FOREIGN BODY VIA RIGHT FEMORAL VEIN. THE CENTRAL CATHETER COULD NOT BE ACCESSED ONE MONTH FOLLOWING INSERTION; SO A RADIOLOGICAL EXAMINATION (CONTRAST STUDY) WAS DONE. THE STUDY REVEALED THAT THE CATHETER HAD BEEN DISLODGED FROM THE RESERVOIR NIPPLE AND WAS NOW INTRACARDIAC. THE INNER WIRE OF THE CATHETER REMAINED ATTACHED TO THE EXTERNAL PORT; HOWEVER, THE CATHETER HAD SLIPPED OVER THE INNER WIRE AND WAS INTRAVASCULAR WITH THE DISTAL TIP IN THE RIGHT VENTRICLE AND THE PROXIMAL TIP OVERLYING THE REGION OF THE JUNCTION OF THE RIGHT SUBCLAVIAN AND JUGULAR VEINS. UPON EXCISION OF THE RESERVOIR, IT WAS NOTED THAT THE PROXIMAL END OF THE CATHETER WAS STILL ATTACHED TO THE RESERVOIR WITH THE LOCK IN PLACE. THE CENTRAL CATHETER HAD BURST JUST BEYOND THE NIPPLE OF THE RESERVOIR. PT TOLERATED BOTH PROCEDURES AND WAS DISCHARGED THE FOLLOWING DAY.
PT WAS SEEN ON 2/22/95 AND 7/12/95 AND EXAMINED WITH DIGITALLY ENHANCED FLUOROSCOPY. BOTH EXAMINATIONS WERE READ AS NEGATIVE, AND NOT SUSPECT FOR FRACTURE. WHEN EXAMINED ON 11/6/95, A LEAD FRACTURE WITHOUT PROTRUSION WAS NOTED NEAR THE ANODE. THERE DOES NOT APPEAR TO BE ANY PROTRUSION OF THE WIRE.
INITIAL SCREENING ON 3/9/95 INDICATED A SINGLE FRACTURE. REPEAT SCREENING ON 10/6/95 INDICATED A SECOND FRACTURE WITH POSSIBLE PROTRUSION. NO LEAD EXTRACTION WAS ATTEMPTED DUE TO THE PT'S POOR HEALTH. THE PT EXPIRED AT HOME ON 10/26/95. ALTHOUGH LEAD INVOLVEMENT CANNOT BE RULED OUT IN THAT NO AUTOPSY WAS OBTAINED, FOLLOWING CARDIOLOGIST IS OF THE OPINION THAT DEATH WAS PROBABLY DUE OT AN UNRELATED VENTRICULAR ARRHYTHMIA.
USING ELECTROHYDRAULIC LITHOTRIPTER PROBE SET ON 70 WATTS. THE END OF THE FIBER CAME OFF IN PT URETER (?BURNT OFF). THE PHYSICIAN WAS ABLE TO REMOVE THE FIBER.
THIS PT HAS BEEN SCREENED TWICE PRIOR TO THE SCREENING PERFORMED TODAY. THE MOST RECENT SCREENING WITH DIGITALLY INHANCED FLUOROSCOPY PRIOR TO TODAY WAS ON 6/16/95, AND NO INDICATION OF FRACTURE OF THE ATRIAL J-WIRE WAS NOTED AT THAT TIME. ON FLUOROSCOPY PERFORMED TODAY, THERE APPEARS TO BE A BREAK IN THE J-WIRE APPROX 1 CM FROM THE ANODE.
ENCOUNTERED DIFFICULTY ADVANCING GUIDE WIRE THROUGH PERCUTANEOUS ACCESS NEEDLE. UNABLE TO PULL WIRE BACK. UNSUCCESSFULLY ATTEMPTED TO INSERT SHEATH SO AS NOT TO LOSE ARTERIAL ACCESS AND TO EXCHANGE WIRE. BY THIS TIME HAD MANAGED TO EXTRACT WIRE PARTIALLY AND IT BECAME APPARENT THAT THE WIRE CORE WAS SEPARATED FROM THE TEFLON COATING. UNABLE TO PASS A NEEDLE OVER THE AREA SO REMOVED THE GUIDE WIRE AND STARTED OVER.
TEH PT WAS SCREENED WITH DIGITALLY ENHANCED FLUOROSCOPY FOR THE SECOND TIME TODAY. THERE IS AN APPARENT FRACTURE 1-2 CM FROM THE ANODE WITH SLIGHT "TENTING" OF THE SHEATH MATERIAL. NO DECISION HAS YET BEEN MADE REGARDING EXTRACTION.
DURING AN ARTERIOGRAM, WHILE ADVANCING THE GUIDE WIRE THROUGH A PIGTAIL CATHETER, THE PHYSICIAN BEGAN NOTICING RESISTANCE. THE VIDEO SCREEN SHOWED THE INNER CORE HAD POPPED OUT OF ONE OF THE SIDE HOLES, AND THE EXTERIOR PORTION HAD ADVANCED THROUGH THE NORMAL LUMEN. THE CATHETER WAS REMOVED, NO INJURY TO THE PT.
THERE IS A DISTINCT CHANGE IN THE CONFIGURATION OF THE LEAD AT THE ANODE, WHEN COMPARED WITH FLUOROSCOPY PERFORMED ON 3/28/95. THIS WAS INTERPRETED AS A LEAD FRACTURE. AS WELL, WHEN MULTIPLE IMAGES ARE VIEWED SEQUENTIALLY, THE ELECTRODE PORTION OF THE LEAD AND THE REMAINDER APPEAR TO MOVE IN A "DISJOINTED" MANNER IN RELATION TO THE HEARTBEAT. NO DECISION AS YET REGARDING EXPLANATION, PARTIALLY DUE TO THE PT'S AGE.
DURING SECOND PUNCTURE FOR LAPAROSCOPY, WHEN INSIDE AND VIEWED BY CAMERA, IT WAS NOTICED THAT A PORTION OF THE GRAY PART OF THE TROCAR WAS TORN. THE TROCAR WAS PULLED OUT AND REPLACED. THE PORTION OF THE TROCAR THAT WAS TORN OFF WAS LOCATED INSIDE OF THE ABDOMEN AND REMOVED. NO APPARENT INJURY TO THE PT.
ANESTHESIA VENTILATOR TIDAL VOLUME CONTROL MADE A "CLICK" SOUND WHILE BEING ADJUSTED AND VENTILTOR STOPPED OPERATING. TIDAL VOLUME WAS STUCK AT LOW. PT VENTILATION CONTINUED BY BAG.
TWO WEEKS S/P ACL/LCL RECONSTRUCTION; RIGHT KNEE WITH LOOSE WASHER.
FAILED ACETABULAR CUP AND POLY INSERT; ECCENTRIC ACETABULAR POLY WEAR RIGHT HIP REQUIRING REVISION SURGERY.
WHILE DIALYSIS CATHETER WAS BEING INSERTED INTO RIGHT SUBCLAVIAN, GUIDE WIRE UNRAVELLED. CATHETER AND WIRE WERE REMOVED. NEW CATHETER REINSERTED LATER THAT SAME DAY AT THE SAME SITE WITH COMPLICATIONS EXPERIENCED.
RIGHT INDEX FINGER BLOOD BLISTER INJURY WHEN FINGER WAS CAUGHT BETWEEN WEIGHT BAR AND SIDE OF MACHINE. DEVICE DESIGN ISSUE.
A PERCUTANEOUS CENTRAL VENOUS CATHETER WAS PLACED. WHILE ATTEMPTING TO REMOVE THE INTRODUCING SPLITTING NEEDLE, THE CATHETER SHEARED, AND A PORTION OF THE CATHETER ENTERED THE PT AND WAS LODGED.
PT CAME TO HOSP IN PULMONARY EDEMA, WITH SEVERE DYSPNEA, CHEST PAIN AND ATRIAL FIBRILLATION. ECHOCARDIOGRAM AND CARDIAC CATHETERIZATION REVEALED THROMBOSIS OF MITRAL VALVE PROSTHESIS AND RECURRENT MITRAL STENOSIS. MITRAL VALVE IMPLANTED ELSEWHERE ON 1/12/90. OLD MITRAL VALVE EXPLANTED ON 8/16/95 AND NEW PROSTHESIS IMPLANTED WITH CORONARY ARTERY BYPASS GRAFT (LAD). CARDIAC CATH, CINEANGIOGRAPHY OF CORONARY ARTERY DEMONSTRATED ONLY ONE OF TWO LEAFLETS OF GRAFT APPEARED TO BE MOVING, OTHER ONE WAS CLOSED. AT OPERATION, MITRAL VALVE FOUND COMPLETELY THROMBOSED. ONE LEAFLET IN PIECES UPON REMOVAL FROM PT.
FAILED LEFT HEMIARTHROPLASTY WITH HIP DISLOCATION; SHELL OF BIPOLAR PROSTHESIS WAS DISLODGED FROM HEAD OF PROSTHESIS.
THE VENTRICULAR LEAD WAS REMOVED FOR FAILURE. POLYURETHANE DETERIORATION WAS NOTED.
ATRIAL LEAD WAS REMOVED FOR INAPPROPRIATE SENSING.
FIRE ORIGINATED IN THE RNICU USING THE RADIANT WARMER. IT IS BELIEVED THAT THE FIRE ORIINATED AT THE CONNECTION BETWEEN THE DETACHABLE POWER CORD AND THE RADIANT WARMER. MFR WAS NOTIFIED IMMEDIATELY AND ITS FIELD ENGINEER PROVIDED CLAMPS FOR ADEQUATE STRAIN RELIEF ON THE CABLE. THERE WERE NO PT OR STAFF INJURIES RELATED TO THIS INCIDENT.
IABP BALLOON WOULD NOT AUTO OR MANUALLY FILL. AN ATTEMPT WAS MADE TO SWITCH THE FAULTY BALLOON WHICH RESULTED IN FEMORAL ARTERY TRAUMA WITH INCREASED BLEEDING INTO THE LEG.
ON 9/2/95 CATHETER INSERTED WITH X-RAY CONTROL. CATHETER STARTED LEAKING FOUR DAYS LATER. ON 9/15/95 CATHETER WAS REMOVED. CRACK IDENTIFIED IN BETWEEN BOTH CUFFS.
DURING ANGIOPLASTY, UNABLE TO REMOVE 10MM X 4CM BALLOON CATHETER FROM ANOTHER MFR'S SIZE 7F SHEATH. VASCULAR ACCESS ENLARGED BY REMOVAL. SURGERY REQUIRED TO REPAIR LEFT FEMORAL ARTERY.
NON-CAPTURE OF LEAD. LEAD EXPLANTED ON 9/18/95.
DEVICE LEAKING FLUID AT SKIN LEVEL FROM ONE PORT REQUIRING REPLACEMENT OF CATHETER.
FAILED INTRAMEDULLARY NAIL OF RIGHT FEMUR ORIGINALLY IMPLANTED 3 MONTHS PRIOR TO REPAIR A COMMINUTED SUPRACONDYLAR FRACTURE.
FAILURE OF HARDWARE IN RIGHT HIP A FEW MONTHS S/P BILATERAL FEMORAL VARUS ROTATIONAL OSTEOTOMIES WITH THE 3 MOST PROXIMAL SCREWS ON THE SIDE PLATE SHEARED OFF AT THE HIP.
PCVC LINE INSERTED WITHOUT EVENT. UPON REMOVAL OF INTRODUCING SPLITTING NEEDLE THE CATHETER WAS NOTED TO BE HALF INTACT. CHEST X-RAY SHOWED A SMALL CALIBER CURVALINEAR DENSITY WITHIN THE CARDIAC SILHOUETTE.
A 27 GAUGE 3-1/2" NEEDLE BROKE DURING AN ATTEMPTED SPINAL ANESTHESIA. ONE AND ONE HALF INCHES OF THE NEEDLE REMAINED IMBEDDED AND HAD TO BE SURGICALLY REMOVED. INITIAL SKIN PUNCTURE WAS MADE WITH A 17 GAUGE NEEDLE.
DURING USE OF ENDOLIGATOR, THE LIGATING CYLINDER FELL OFF AND REQUIRED RETRIEVAL BY THE ENDOSCOPIST WITHOUT INCIDENT. A SECOND ATTEMPT TO USE THE LIGATOR RESULTED IN THE BREAKING AWAY OF THE BALL AT END OF TRIP WIRE. USE WAS DISCONTINUED.
PORT PLACED FOR ADMINISTRATION OF CHEMOTHERAPY DEVELOPED LEAK IN CONNECTION BETWEEN RESERVOIR AND ADMINISTRATION TUBING. THIS WAS DISCOVERED WHEN CONTRAST WAS INJECTED THROUGH THE PORT. PT RECEIVED CHEMOTHERAPY PRIOR TO DETECTION OF LEAK BUT SUSTAINED NO INJURY. CAUSE OF LEAK BELIEVED TO BE CAUSED BY DEVICE BLADE DURING INSERTION.
PACEMAKER WAS INTERROGATED AND IT DEMONSTRATED INTERMITTENT FAILURE TO SENSE VENTRICULAR ACTIVITY. PT UNDERWENT EXPLANT AND REPLACEMENT OF THE LEAD.
PT EXPERIENCED SKIN DISCOLORATION ON EACH THIGH WHERE ELECTROCAUTERY GROUND PADS HAD BEEN PLACED.
PT RECEIVING ULTRASOUND DURING PHYSICAL THERAPY TO DORSAL FOOT WHEN A SMALL SHOCK WAS FELT.
PT COMPLAINED OF SUDDEN BACK AND SHOULDER PAIN. EVALUATION SHOWED REDNESS AROUND THE PORT AND PAIN IN THE LEFT SHOULDER AND LEFT ARM. FLUOROSCOPY SHOWED CATHETER FRACTURED WITH TIP IN RIGHT ATRIUM. THE CATHETER WAS REMOVED SURGICALLY. CLINICAL ENGINEERING EVALUATION WAS NON-CONCLUSIVE. IT IS POSTULATED THE FRACTURE COULD BE SECONDARY TO PINCH-OFF SYNDROME, A KNOWN COMPLICATION OF SUBCLAVIAN PLACEMENT OF IMPLANTABLE PORTS.
PT HAD 8 FIRINGS OF HIS AICD WHILE SITTING AT THE COMPUTER. INTERROGATION OF THE DEVICE AND CHEST X-RAY REVEALED A FRACTURE OF THE RIGHT VENTRICULAR COIL. THE DEVICE WAS EXPLANTED.
DURING VITRECTOMY AND MEMBRANE PEEL, EYE PRESSURE NEEDED TO BE LOWERED. WHEN THE FOOTSWITCH ON THE VITRECTOMY MACHINE WAS ACTIVATED, IT BECAME MECHANICALLY STUCK IN THE "ON" POSITION DISCONNECTING THE FOOTSWITCH, PRESSURE WAS INCREASED USING THE FRONT PANEL CONTROLS.
SUTURE NEEDLE BROKE DURING SURGICAL PROCEDURE. FRAGMENT COULD NOT BE REMOVED AT THE TIME. REQUIRED ADD'L SURGERY TO REMOVE FOREIGN BODY.
LEFT KNEE IMPLANT 12/5/89, REPLACED TIBIAL INSERT 1/16/96, PT DEVELOPED PAIN. PHYSICIAN THINKS BREAKDOWN MAY BE DUE TO GAMMA RADIATION.
A PT HAD SUCCESSFULLY RECEIVED A FOUR-FIELD TREATMENT USING OBLIQUE GANTRY ANGLES AND CUSTOMIZED BLOCKING FOR EACH FIELD. THE STAFF TECHNOLOGIST WAS IN THE PROCESS OF REMOVING THE PT FROM THE TREATMENT COUCH WHEN ONE OF THE CASTED SIDE SUPPORTS FOR THE TRAY ASSEMBLY, THE TRAY ITSELF, AND THE BLOCKS USED FOR THE TREATMENT CRASHED TO THE FLOOR. THE GANTRY ANGLE AT THAT MOMENT WAS APPROXIMATELY 45 DEGREES AND FORTUNATELY, NEITHER THE TECHNOLOGIST NOR THE PT WERE STRUCK BY ANY FALLING OBJECTS. A MFR'S SERVICE ENGINEER WHO WAS ON-SITE AT THE TIME WAS CALLED IN IMMEDIATELY. INSPECTION OF THE SHADOW TRAY UNIT SHOWED THAT A FRACTURING OF THE SIDE SUPPORT OCCURRED PRECISELY AT THE LEVEL OF THE THREADED SHAFTS THAT ARE MACHINED INTO THE CASTED ASSEMBLY. THE SHAFTS ACCOMMODATE THE SCREWS THAT SECURE THE HANDLES TO THE UNIT. THE TECHNOLOGISTS REPORTED NO INSTANCES OF ACCIDENTS OR MISUSE REGARDING THE TRAY ASSEMBLY. INSPECTION OF THE ASSEMBLY DID NOT SHOW ANY OTHER DAMAGE. THE BLOCKS USED IN THIS INSTANCE WEIGHED 8 POUNDS WHICH IS WELL WITHIN THE MFR'S MAXIMUM LOAD OF 33 POUNDS. IN AN EFFORT TO PREVENT FUTURE RECURRENCES RPTR'S SERVICE ENGINEER IS BEING INSTRUCTED TO PERIODICALLY CHECK ALL SHADOW TRAYS FOR ANY SIGNS OF CRACKING OR LOOSENESS AS PART OF THE ROUTINE PREVENTIVE MAINTENANCE PROGRAM. THE MFR, FOR THEIR PART, MAY WISH TO CONSIDER THE FOLLOWING MEASURES: 1. REINFORCEMENT FOR THE AREA AROUND THE THREADED SHAFTS, AND 2. IMPLEMENTATION OF TESTING AT THE FACTORY LEVEL THAT WOULD BE CAPABLE OF DETECTING THE PRESENCE OF HAIRLINE FRACTURES IN THE CASTED MATERIAL PRIOR TO SHIPMENT. (*)
ON 1/30/96 ATTEMPTS WERE MADE TO PULL THE PTCA STENT INTO THE GUIDING CATHETER AND INTO THE ARTERIAL SHEATH. STENT LOST DURING ATTEMPT.
THREE PATIENTS HAVE CONTACTED RPTR CONCERNING LEAKING OF TUBING NEAR THE FILTER. RIGHT TUBING WAS FROM THE SAME LOT NUMBER.
RPTR STATED THAT EVERYTHING STARTED WHEN SHE GOT HER SILICONE BREAST IMPLANT IN 1974. SHE LATER DEVELOPED RASHES AND WAS PREGNANT AT THE TIME. THE DR TOLD HER THAT SHE WAS ALLERGIC TO A NEW DETERGENT. SHE FOUND OUT LATER THAT SHE WASN'T ALLERGIC TO IT. RPTR STATED THAT SHE DEVELOPED PNEUMONIA, BRONCHITIS, AND VERY FREQUENT COLDS. THE FIRST TIME SHE DEVELOPED BRONCHITIS WAS IN 1979. IN 1992, SHE HAD THE SILICONE IMPLANTS EXPLANTED AND SINCE THEN SHE HAS NOT EXPERIENCED PNEUMONIA OR BRONCHITIS AND HAS VERY FEW COLDS. WHEN HER IMPLANTS WERE REMOVED, HER BREASTS WERE "ROCKHARD." SHE EXPERIENCED FATIGUE FOR YEARS, HAIR LOSS AND JOINT PAIN. SHE WAS NOT ABLE TO LIE DOWN ON HER SIDE BECAUSE HER SHOULDER HURT SO BAD. SHE COULD ONLY LIE DOWN ON HER BACK. SHE WAS DIAGNOSED WITH SCLERODERMA. SHE HAS NO DOUBT THAT HER PROBLEMS WERE CAUSED BY THE SILICONE. ACCORDING TO HOSP SURGICAL PATHOLOGY REPORT THE IMPLANTS WERE GROSSLY RUPTURED WITH A LARGE TEAR. THE CAPSULE CONSISTS OF A THIN MEMBRANOUS TISSUE WHICH IS FOCALLY THICKENED INTO WHITE TO YELLOW FIBROTIC PATCHES. IN ADDITION, THERE IS SOME ATTACHED ADIPOSE TISSUE ALONG WITH FOCAL AREAS. THE PERIPHERY CONSISTS OF CHALKY GREEN TO WHITE INORGANIC MATERIAL. (ALSO SEE 1008494)
RPTR STATED THAT EVERYTHING STARTED WHEN SHE GOT HER SILICONE BREAST IMPLANT IN 1974. SHE LATER DEVELOPED RASHES AND WAS PREGNANT AT THE TIME. THE DR TOLD HER THAT SHE WAS ALLERGIC TO A NEW DETERGENT. SHE FOUND OUT LATER THAT SHE WASN'T ALLERGIC TO IT. RPTR STATED THAT SHE DEVELOPED PNEUMONIA, BRONCHITIS, AND VERY FREQUENT COLDS. THE FIRST TIME SHE DEVELOPED BRONCHITIS WAS IN 1979. IN 1992, SHE HAD THE SILICONE IMPLANTS EXPLANTED AND SINCE THEN SHE HAS NOT EXPERIENCED PNEUMONIA OR BRONCHITIS AND HAS VERY FEW COLDS. WHEN HER IMPLANTS WERE REMOVED, HER BREASTS WERE "ROCKHARD." SHE EXPERIENCED FATIGUE FOR YEARS, HAIR LOSS AND JOINT PAIN. SHE WAS NOT ABLE TO LIE DOWN ON HER SIDE BECAUSE HER SHOULDER HURT SO BAD. SHE COULD ONLY LIE DOWN ON HER BACK. SHE WAS DIAGNOSED WITH SCLERODERMA. SHE HAS NO DOUBT THAT HER PROBLEMS WERE CAUSED BY THE SILICONE. ACCORDING TO HOSP SURGICAL PATHOLOGY REPORT THE IMPLANTS WERE GROSSLY RUPTURED WITH A LARGE TEAR. THE CAPSULE CONSISTS OF A THIN MEMBRANOUS TISSUE WHICH IS FOCALLY THICKENED INTO WHITE TO YELLOW FIBROTIC PATCHES. IN ADDITION, THERE IS SOME ATTACHED ADIPOSE TISSUE ALONG WITH FOCAL AREAS. THE PERIPHERY CONSISTS OF CHALKY GREEN TO WHITE INORGANIC MATERIAL. (ALSO SEE 1008493)
PT HAD SURGERY FOR BREAST IMPLANT EXCHANGE. RIGHT BREAST IMPLANT FOUND DEFLATED WITH YELLOW-COLORED LIQUID. LEFT BREAST IMPLANTS INFLATED WITH CLEAR LIQUID WITHIN SALINE FILLED IMPLANTS.
RPTR WAS IMPLANTED WITH SILICONE POLYURETHANE IMPLANTS. ON DEC 4, 1979 SHE PASSED OUT. IN 1980 SHE STARTED HAVING GRADUAL HEALTH PROBLEMS LIKE FATIGUE AND IMMUNE DYSFUNCTION. IN 1988 SHE DEVELOPED HIGH BLOOD PRESSURE AND KIDNEY AND LIVER PROBLEMS. BY 1990 HER BODY COMPLETELY COLLAPSED AND SHE WAS DIAGNOSED WITH CHRONIC FATIGUE, IMMUNE DYSFUNCTION, FIBROMYALGIA, PROGRESSIVE KIDNEY AND LIVER FAILURE, AND NEUROLOGICAL DISORDERS; SHE ALSO HAS LUPUS. SHE IS COMPLETELY DISABLED NOW. SHE WAS EXPLANTED 2/92, THE LEFT IMPLANT WAS RUPTURED. HER HEALTH HASN'T GOTTEN BETTER. SHE IS STILL VERY SICK. SHE WAS DIAGNOSED WITH RENAL AND HEPATIC DYSFUNCTION 9 YEARS AFTER THE IMPLANTATION.
DURING A CARDIAC CATHETERIZATION, PART OF THE WIRE COIL SURROUNDING THE WIRE CORE OF THE INTRODUCER SEPARATED FROM THE CORE AND LODGED IN THE TISSUE. WHEN THE INTRODUCER WAS WITHDRAWN, THE COIL WIRE BROKE AND APPROXIMATELY 1 1/2" SECTION REMAINED IN THE PT'S TISSUE OUTSIDE OF THE ARTERY.
IN 1982 RPTR'S LEFT BREAST IMPLANT RUPTURED, RIGHT SALINE IMPLANT REMOVED. FROM 1982 TO THE PRESENT TIME, SHE HAS HAD ABDOMINAL PAIN, SHORTNESS OF BREATH, BURNING PAIN IN CHEST, JOINT PAIN AND MUSCLE ACHES, FIBROMYALGIA, DEPRESSION, INSOMNIA, TINGLING AND NUMBNESS IN RIGHT ARM AND HAND, MUSCLE WEAKNESS, HEADACHES, DRY ITCHY EYES, TMJ SYNDROME, ENVIRONMENTAL ILLNESS, MULTIPLE CHEMICAL SENSITIVITIES (MOST SEVERELY SILICONE AND SILICONE PRODUCTS.
PENILE PROSTHESIS FAILED AND WAS EXPLANTED. EVALUATION DURING SURGERY REVEALED THE TUBING TO THE LEFT CORPORA WAS BROKEN OFF AT THE PUMP.
PACEMAKER INTERROGATION REVEALED OVERSENSING (CURRENT) AND UNDERSENSING IN THE PAST. THE PT STATED THAT HE FELT LIKE HE DID BEFORE THE PACEMAKER WAS IMPLANTED. PT'S PRIMARY PROBLEM WAS WEAKNESS, SOME QUESTION OF CHEST PAIN AND A QUESTION OF SHORTNESS OF BREATH. THE PACEMAKER WAS SURGICALLY EXPLANTED.
SIX TO SEVEN MONTHS FOLLOWING IMPLANT OF FIXATION DEVICE, PT HAD FRACTURE OF NAIL AND PROBLEMS WITH HEALING. PT DEVELOPED CELLULITIS SECONDARY TO STAPH AUREUS AT THE FRACTURE/FIXATION SITE. X-RAY CONFIRMED FRACTURE OF THE INTRAMEDULLARY NAIL. NAIL AND SCREWS EXPLANTED IN TWO OPERATIONS ON 9/14/95 AND 9/18/95.
PACEMAKER FOLLOW-UP DEMONSTRATED A FAILURE TO SENSE AND RECENT DROP IN RESISTANCE FROM 9/94 (384 OHMS) TO 10/95 (280 OHMS).
ON INTERROGATION PT WAS FOUND TO HAVE TOTAL LOSS OF VENTRICULAR CAPTURE-CHRONIC PERMANENT VENTRICULAR LEAD FAILURE. THE VDI SYSTEM WAS EXPLANTED AND REPLACED.
PHACOEMULSIFICATION OF MATURE SENILE CATARACT WAS ATTEMPTED. THE PHACO DID NOT WORK DESPITE REPEATED ATTEMPTS. SURGERY WAS CONVERTED TO AN EXTRACAPSULAR CATARACT EXTRACTION, LENGTHENING SURGERY TIME AND RECOVERY TIME.
PT WAS IN CARDIAC ARREST AND HAD SIGNIFICANT ABDOMINAL DISTENTION. A #16 NG WITH ANTI-REFLUX VALVE INSERTED. TUBE WOULD NOT WITHDRAW. ATTEMPTS MADE TO INJECT AIR INTO TUBE AND REPOSITION WERE UNSUCCESSFUL IN GETTING TUBE TO FUNCTION. TUBE REMOVED AND FOUND TO HAVE NO HOLES IN THE DISTAL END OF THE TUBE. THERE WAS A 10 MIN DELAY IN EVACUATION OF STOMACH IN ORDER TO VISUALIZE THE ABDOMEN ON ULTRASOUND.
INTRA-AORTIC BALLOON CATHETER WAS INSERTED 7/12/95 AFTER A CARDIAC CATHETERIZATION. PT THEN HAD CORONARY ARTERY BYPASS GRAFTING. ON 7/18/95, THE IABP WAS NOTED NOT TO BE FUNCTIONING. THE BALLOON WAS NOTED TO BE LEAKING. THE CATHETER WAS REMOVED. THE PT REMAINED HEMODYNAMICALLY STABLE.
DURING A CARDIAC ARREST, THE PT WAS INTUBATED WITH AN 8.0 ENDOTUBE. BILATERAL BREATH SOUNDS WERE EQUAL. THE CO2 DETECTOR WAS APPLIED AND THE COLOR DID NOT CHANGE. THE SCOPE WAS RE-INSERTED; THE ENDOTUBE WAS CHECKED AGAIN AND VISUALIZED THROUGH THE VOCAL CORDS. THE SECOND CO2 DETECTOR WAS APPLIED AND THE COLOR DID NOT CHANGE. BILATERAL BREATH SOUNDS WERE EQUAL. OXYGEN SATURATION - 96%.
PT CAME TO THE ER WITH G-TUBE ALMOST OUT. ATTEMPT MADE TO DEFLATE BALLOON TO REMOVE TUBE AND NO FLUID WAS RETRIEVED. GASTROSTOMY TUBE REMOVED AND A LONGITUDINAL SPLIT WAS NOTED IN THE BALLOON. A NEW G-TUBE WAS THEN REINSERTED.
PT WITH A POSSIBLE BILE LEAK AND COMMON BILE DUCT STONE HAD AN ERCP AND A SPHINCTEROTOMY WITH BALLOON AND BASKET EXTRACTION OF STONES. DURING EXTRACTION OF A STONE IN THE PROXIMAL COMMON BILE DUCT, A 5 FR BASKET WAS INTRODUCED THROUGH THE DUODENOSCOPE BEYOND THE STONE. THE BASKET WAS OPENED AND THE STONE WAS ENCASED IN THE BASKET. WHILE ATTEMPTING TO PUSH THE BASKET DOWN TO RETRIEVE THE STONE, IT WAS FOUND THAT THE BASKET HAD BROKEN ABOUT 15-20 CM FROM THE BASKET WIRE. A SNARE WAS INSERTED TO RETRIEVE THE BASKET BUT IT WAS DIFFICULT TO PASS THE SNARE AROUND THE BASKET. THE SNARE WAS REMOVED AND FORCEPS INSERTED. THE BASKET WAS THEN DISENGAGED FROM THE DUODENAL MUCOSA. THE PT TOLERATED THE PROCEDURE WELL WITH ADDITIONAL SEDATION.
THE PT WAS HAVING A SIGMOID POLYPECTOMY. AFTER THE COLONOSCOPE AND SNARE WERE PASSED, THE SNARE WAS PLACED ONTO THE STEM. THE AREA WAS BEING COAGULATED WHEN THE SNARE DISENGAGED, BROKE AND NO FURTHER COAGULATION WAS ABLE TO BE DONE. UPON DISENGAGING, THE SNARE OPENED, THE POLYP WAS PARTIALLY RESECTED. THERE WAS A SMALL AMOUNT OF BLEEDING THAT OCCURRED AND EPINEPHRINE WAS INJECTED INTO THE RESECTED AREA.
PT RECEIVING OXYGEN VIA FACE MASK AT 60%. PULSE OXIMETER NOTED TO BE 98%. A SUDDEN DROP WAS NOTED IN THE PULSE OXIMETER READING. THE READING DECREASED TO 77%. THE OXYGEN SET-UP WAS CHECKED BY THE NURSE AND OXYGEN FLOW THROUGH THE FACE MASK WAS MINIMAL. FACE MASK REMOVED FROM TUBING AND OXYGEN FLOW AGAIN CHECKED - MINIMAL FLOW AGAIN NOTED THROUGH TUBING. FACE MASK PLACED BACK ON PT WHILE THE NURSE WENT TO OBTAIN A PORTABLE OXYGEN TANK. WITHIN A FEW MINUTES, THE PT HAD A RESPIRATORY ARREST. CPR BEGUN; PT INTUBATED; PT DEFIBRILLATED AND MEDICATION GIVEN. HEART RHYTHM RETURNED.
DURING THE PLACEMENT OF A STENT INTO THE RIGHT CORONARY ARTERY, THE TIP OF THE GUIDE WIRE BROKE OFF IN THE ARTERY. THE PT WAS THEN TAKEN EMERGENTLY TO SURGERY FOR REMOVAL OF THE GUIDE WIRE AND CORONARY ARTERY BYPASS GRAFTING.
A DILITATION WAS DONE OF THE LEFT SUBCLAVIAN ARTERY AND A STENT WAS PLACED. DURING PLACEMENT OF A SECOND STENT DISTAL OF THE FIRST, THE BALLOON RUPTURED DURING EXPANSION. WHILE PULLING THE BALLOON CATHETER OUT, BOTH STENTS MIGRATED INTO THE AORTA. USING A SNARE CATHETER, BOTH STENTS WERE PULLED DOWN TO THE RIGHT FEMORAL ARTERY. THE PT WAS THEN TAKEN TO THE OR FOR SURGICAL REMOVAL OF THE STENTS.
PT FOUND TO HAVE 3 EPISODES OF ABORTED DEFIB THERAPY ON EKG ANALYSIS. PROBLEM FELT TO BE DUE TO A CONNECTION PROBLEM AT THE ICD PULSE GENERATOR LADER.
A CATHETER WAS BEING INSERTED INTO THE PT'S RIGHT SUBCLAVIAN VEIN USING A CATHETER KIT. THE PT'S VEIN WAS CANNULATED EASILY, THE DILATOR PASSED, THE GUIDE WIRE INSERTED AND THE CATHETER THREADED. WHEN ATTEMPTING TO REMOVE GUIDE WIRE, THERE WAS DIFFICULTY REMOVING IT AND RESISTANCE WAS MET. ON REMOVAL OF WIRE, WIRE NOTED TO BE UNRAVELED. A CHEST X-RAY WAS OBTAINED AFTER THE PROCEDURE AND A SMALL PIECE OF THE GUIDE WIRE WAS NOTED IN THE SUBCLAVIAN VEIN. THE PT WAS TAKEN TO THE OPERATING ROOM FOR RETRIEVAL OF THE RETAINED PIECE OF GUIDE WIRE.
PT HAD A RUPTURED RIGHT SILICONE BREAST IMPLANT. SALINE IMPLANTS WERE REPLACED BILATERALLY.
LEFT SALINE IMPLANT DEFLATED; OPEN CAPSULECTOMY AND REPLACEMENT OF   IMPLANT.
PT UNDERWENT LEFT MODIFIED RADICAL MASTECTOMY IN 1988; HAD SILICONE IMPLANTS PLACED. PT HAS HAD CONCERNS REGARDING THE SILICONE DETERIORATING AND WISHES IMPLANTS TO BE REPLACED WIH SALINE.
PT UNDERWENT REMOVAL OF PATELLA IMPLANT FOR SYMPTOMATIC RELIEF. POLY COVERING DESCRIBED AS "WORN TO METAL" UPON EXPLANTATION. NEW PATELLA COMPONENT PLACED.
PORT ADAPTER BECAME DETACHED FROM JEJUNAL TUBE WHERE IT WAS UNABLE TO BE USED. REQUIRED REPLACEMENT OF TUBE.
PT HAD BILATERAL BREAST AUGMENTATION IN 1984 WITH PLACEMENT OF SILICONE IMPLANTS. IMPLANTS WERE REPLACED WITH SALINE IN 1990. PT NOW HAS MALPOSITION AND RUPTURE OF RIGHT IMPLANT. SCAR REVISION, MASTOPEXY AND  IMPLANT EXCHANGE OF RIGHT; COSMETIC LEFT BREAST IMPLANT EXCHANGE.
PT EXPERIENCED INAPPROPRIATE SHOCKS FROM DEFIBRILLATOR. AT TIME OF SURGICAL EXPLANTATION, IT WAS DISCOVERED THAT THERE WAS A BREAK IN THE INSULATION.
AN 83 YEAR OLD FEMALE UNDERGOING CATARACT EXTRACTION WITH LENS IMPLANT TO RIGHT EYE. PRIOR TO PLACEMENT, IT WAS NOTED THAT THE HAPTIC WAS BROKEN ON ONE SIDE. LENS WAS UNABLE TO BE USED AND HAD TO BE SUBSTITUTED.
PENILE PROSTHESIS DESCRIBED AS NON-FUNCTIONING FOR TWO YEARS PRIOR TO EXPLANTATION ON 8/15/95.
A 51 YEAR OLD FEMALE UNDERGOING CATARACT EXTRACTION WITH LENS IMPLANT TO RIGHT EYE. DURING PROCEDURE AND PLACEMENT OF LENS, THE HAPTIC BROKE. SUBSTITUTION NEEDED.
PT UNDERWENT SURGICAL REPLACEMENT OF PATELLA IMPLANT. EXPLANTED DEVICE HAD WORN PATELLA AND ARTICULATING TIBIAL SURFACES.
PT UNDERWENT SURGICAL REMOVAL OF PERMANENT HEMODIALYSIS CATHETER BECAUSE IT WAS NON-FUNCTIONING. PT RECEIVED A PERMANENT VASCULAR ACCESS IN FORM OF LUBED VASCULAR GRAFT OF LEFT FOREARM, TO REPLACE THE NON-FUNCTIONING DEVICE.
DURING LAPAROSCOPIC SURGERY THE DISTAL TIP BECAME DISLODGED FROM INSTRUMENT AND FELL INTO ABDOMINAL CAVITY. SURGEON WAS ABLE TO RETRIEVE THE TIP.
PT UNDERWENT BILATERAL MASTECTOMY IN 5/95; LEFT & RIGHT TISSUE EXPANDER REMOVED PRIOR TO INSERTION OF SALINE IMPLANTS AND EXPANDERS RUPTURED UPON REMOVAL.
THE PHYSICIAN ATTEMPTED TO USE THE STAPLER ON A LAVH. ON THE FIRST ATTEMPT THE STAPLING DEVICE FIRED, DID NOT STAPLE AND THEN BROKE OFF IN THE PT. BLEEDING BEGAN AND PHYSICIAN ATTEMPTED ANOTHER DEVICE. THIS DEVICE ALSO MISFIRED. PT HAD TO BE OPENED DUE TO BLEEDING. TOTAL ABDOMINAL HYSTERECTOMY PERFORMED.
PT COMPLAINED OF PROBLEMS WITH HER LEFT KNEE. SHE HAD UNDERWENT A TOTAL LEFT KNEE REPLACEMENT IN 1990 AND WAS FINE UNTIL JULY 1995. PT THEN HAD PROBLEMS OF PAIN AND GIVING OUT OF THE KNEE. CONSERVATIVE TREATMENT FAILED AND FURTHER EVALUATION REVEALED POSSIBILITY OF A FRACTURE OF THE PLASTIC ON THE LATERAL SIDE. SHE THEN UNDERWENT A REVISION OF THE LEFT KNEE ON 10/27/95. OPERATIVE REPORTS SHOW THE LATERAL TIBIAL TRAY HAD FRACTURED OFF WHICH THE SURGEON FELT WAS THE SOURCE OF IT'S PROBLEM. THE REVISION WAS SUCCESSFUL & THE PT RECOVERED. (*).
PER OPERATIVE REPORT, PT HAD AUGMENTATION MAMMOPLASTY WITH RIGHT CAPSULAR CONTRACTION. AFTER TRYING TO TREAT CONSERVATIVELY FOR A LONG TIME IT WAS CLEAR THE BREAST WAS GETTING HARDER, HIGHR AND BECOMING PAINFUL. IMMEDIATELY ON ENTERING THE CAPSULE IT WAS CLEAR THAT THERE WAS STRAW COLORED FLUID SURROUNDING THE IMPLANT. THE INTACT 360 IMPLANT WAS REMOVED.
UNDERWENT BILATERAL EXPLANTATION OF BREAST PROSTHESES, BOTH IMPLANTS HAD SILICONE BLEED, THOUGH SHELLS WERE INTACT.
PLASTIC TOTAL HIP LINER DISENGAGED FROM METAL ACETABULAR SHELL, WHICH WAS REMOVED AND REPLACED.
UNDERWENT BILATERAL EXPLANTATION OF BREAST PROSTHESES AND CAPSULECTOMIES FOR SYMPTOMATIC RELIEF OF PAIN.
THE PT RECEIVED AN INJECTION OF MORPHINE MIXTURE (38MG/12CC NS) TO REFILL PUMP RESERVOIR. AFTER RECEIVING INJECTION, THE PT BECAME LETHARGIC AND WAS BROUGHT TO THE EMERGENCY ROOM FOR NARCOTIC OVERDOSE. SHE REQUIRED HOSPITALIZATION IN THE ICU FOR CONTINUOUS NARCOTIC REVERSAL WITH NARCAN. REPRESENTATIVE WAS CALLED IN TO EVALUATE FOR LEAK OR PUMP MALFUNCTION. THE RESERVOIR WAS EMPTIED AND REFILLED WITH NS. THE PT WAS REFERRED BACK TO HER PRIVATE PHYSICIAN, WHO IS AN ANESTHESIOLOGIST, WHO PLACED PUMP. REPORTED TO PHARMACEUTICAL HOME HEALTH AGENCY AND MFR. ON 11/13/95 FOLLOW-UP WITH FOUND PT STILL HAS PUMP IN PLACE AND FILLED WITH NS. PUMP WILL BE REMOVED AT THE PT'S REQUEST PER DOCTOR. PHYSICIAN STATED (CONTINUED) SHE DOES NOT BELIEVE PUMP MALFUNCTION CAUSED PROBLEM; PROBABLE PROBLEM WITH HOME HEALTH STAFF REFILLING RESERVOIR.
ALARMS PRE-TESTED PRIOR TO DIALYSIS. MODE OF OPERATION: DIALYZE MODE. DIALYSATE PRESSURE ALARM ACTIVATED WITH NO AUDIO TONE; ONLY A RED INDICATOR LIGHT LIT. THE "NO POWER" ALARM WAS FUNCTIONAL. NO PT INJURY. PROBLEM ASSESSED BY HOSP CLINICAL EQUIPMENT DEPARTMENT: "BLOOD ALARM BOARD FAILED AND FRONT PANEL SWITCH (MODE FUNCTION) BROKE."
THE PLASTIC WINGS OF THE SYRINGE SOMETHIMES ROTATE AND TEAR HOLES IN THE PAPER BACKING OF THE PACKAGE RENDERING THE PRODUCT NONSTERILE AND PRESENTING A RISK OF INFECTION IF NOT DISCOVERED BEFORE THE PRODUCT IS USED.
PARAMEDICS ARRIVED AT SCENE OF CODE. PT WAS IN V-FIB AND SHOCKED AT 200 W/S AND INTO ASYSTOLE. EPINEPHRINE AND ATROPINE GIVEN. CPR CONTINUED. PT WENT INTO V-FIB AND WAS SHOCKED AT 300 W/S. WENT INTO A SLOW VENTRICULAR RHYTHM THEN V-TACH WITH PULSES. MONITOR FAILED WHILE ATTEMPTING TO CARDIOVERT V-TACH AND PT WENT INTO V-FIB. AIR AMBULANCE ARRIVED AND ASSUMED CARE. BATTERIES WERE RECHARGED AND STILL UNABLE TO GET MONITOR UP. NEW BATTERY APPLIED AND COULD STILL NOT GET MONITOR UP.
PER OPERATIVE REPORT: 3 MONTHS AFTER INSERTION OF DEVICE IT STOPPED FUNCTIONING PROPERLY. PT IN FOR REMOVAL AND/OR CHANGE OF DEVICE DURING REMOVAL IN OR, THE CATHETER SLIPPED "INTO THE DEEPER TISSUE".AFTER UNSUCCESSFUL ATTEMPT AT RETRIEVAL, A VASCULAR SURGEON WAS CALLED. THIS ATTEMPT ALSO WAS UNSUCCESSFUL. THE PT WAS THEN INTUBATED AND THE RADIOLOGIST WAS CALLED TO REMOVE CATHETER UNDER FLUOROSCOPY. PT WAS EXTREMELY NAUSEATED POST-OP AND REQUIRED HOSPITALIZATION X 2 DAYS. DISCHARGED WITHOUT FURTHER COMPLICATION. DISCOVERED KINKED CATHETER WAS CAUSING PRIMARY MALFUNCTION.
TIP OF DEBRIDER BROKE OFF DURING SURGICAL PROCEDURE. PIECE WAS IMMEDIATELY RETRIEVED CAUSING NO DELAY OR ADVERSE PT OCCURRENCE.
ON 2/19/96 AT 0315 RESIDENT FOUND AT SIDE OF BED ATTEMPTING TO STAND UP AT SIDE OF THE BED WITH ROLLING WAIST RESTRAINT IN PLACE AND SECURED TO BED. STAFF INDICATED HE WAS SHAKING BEDRAILS VIOLENTLY CAUSING ONE SIDE TO RELEASE. RESIDENT RECEIVED A 4 CM LACERATION TO RIGHT EYE.
STAPLER MALFUNCTIONS WHEN TRYING TO CLOSE FOR STAPLING.
PULMONARY ARTERY CATHETER WAS PLACED ON 10/18/95. FOLLOW-UP CHEST X-RAY CONFIRMED GOOD POSITION AND CATHETER WEDGED WITHOUT PROBLEM. ON 10/19/95 NURSE WAS UNABLE TO WEDGE. SEVERAL PHYSICIANS TRIED TO REPOSITION. FOLLOW-UP CHEST X-RAY 10/19/95 SHOWED CATHETER TIGHTLY COILED. ATTEMPT MAD TO REMOVE CATHETER UNSUCCESSFUL. ON 10/19/95 AT BEDSIDE IN ICCU, SURGEON EXPLORED NECK, REMOVED THE KNOTTED CATHETER AND REPAIRED THE JUGULAR VEIN.
DOCTOR HAD PROBLEM OPENING VASCULAR STAPLER AFTER STAPLING TISSUE.
STAPLERS MALFUNCTIONED DURING SURGICAL PROCEEDURES. BLEEDING ALONG STAPLE LINE (BILATERAL).
THIS PT HAD HISTORY OF CHEST DEFORMITY FROM CHILDHOOD. SHE CAME INTO OFFICE COMPLAINING OF TENDER, FIRM LEFT BREAST. PER MEDICAL RECORD, PT HAS HAD MULTIPLE IMPLANTS IN PAST. OPERATIVE DIAGNOSIS, CAPSULAR CONTRACTION SEVERE (LEFT) GRADE IV; CAPSULAR CONTRACTION, MILD (RIGHT) GRADE II; SEVERE BREAST DEFORMITY AND ASYMMETRY SECONDARY TO PECTUS EX CAVATUM AND CHILDHOOD CHEST SURGERY.
PT PRESENTED REQUESTING THAT THE IMPLANTS BE PLACED LOWER AND THAT THE GRADE II CAPSULAR CONTRACTION BE RELIEVED. PT'S POST-OP DIAGNOSIS IS BILATERAL CAPSULAR CONTRACTION AND PTOSIS.
PT WAS TAKEN TO THE OR FOR A CYSTO/TUR. THE SPECIMENS OBTAINED SHOULD DRAIN INTO DRAIN SYSTEM. WHEN THE SURGEON ATTEMPTED TO REMOVE THE SPECIMEN FROM THE TISSUE TRAP, IT WAS NOTED THAT THE TISSUE TRAP WAS DISENGAGED FROM THE DRAINAGE BAG AND THAT THE TISSUE HAD GONE DOWN THE DRAIN EXCEPT FOR 3 OR 4 CHIPS. THERE WAS NO DIRECT ADVERSE RESULT FOR THE PT, HOWEVER MOST OF THE SPECIMEN WAS LOST AND COULD NOT BE SENT TO PATHOLOGY. THE TISSUE THAT WAS TESTED SHOWED BENIGN HYPERPLASIA.
PT WALKING ON LEG PROSTHESIS. THE TUBE ADAPTER COMPONENT OF PROSTHESIS BROKE. PT FELL FRACTURING HIP. SURGICAL REDUCTION AND INTERNAL FIXATION PERFORMED.
INCOMPLETE HEAT SEALING FOR INDIVIDUAL SYRINGES (FOUND LYING IN BOX OUT OF THE HEAT-SEALED PACKAGE). COMPROMISED STERILITY.
LEAK IN BALLOON NOTED DURING ATTEMPTS TO PLACE STENT FOR A LAD LESION IN CORONARY ARTERY. DIFFICULTY WAS ENCOUNTERED IN DEPLOYING HE STENT DUE TO THE LEAK IN THE BALLOON. STENT WAS EVENTUALLY DEPLOYED WITH GOOD RESULTS.
SYRINGE BROKE DURING PRESSURE INJECTION FOR CT SCAN. PT BLED FROM INJECTION SITE DURING SCAN.
DURING UMBILICAL HERNIORRHAPHY SURGEON NOTED THAT TIP OF METZENBAUM SCISSORS WAS BROKEN OFF.
TABLE TOP CENTRIFUGE SHATTERED. THE BROKEN LID WAS FOUND (1/2 ATTACHED, 1/2 ON FLOOR). PIECES OF THE ROTOR WERE SCATTERED THROUGHOUT THE ROOM CAUSING DAMAGE. ONE EMPLOYEE WAS SENT TO EMPLOYEE HEALTH SERVICES FOR MINOR INJURIES.
PT UNDERWENT A CORONARY ANGIOGRAPHY. THE LEFT ANTERIOR DESCENDING ARTERY REVEALED APPROXIMATELY 50% STENOSIS. THE RIGHT CORONARY ARTERY WAS VISUALIZED AND WIRE WAS ADVANCED INTO THE RIGHT CORONARY ARTERY AND PAST THE LESION IN THE MID-ARTERY. AFTER PASSING THE LESION, THE WIRE COULD NOT BE MOVED AND THE TIP OF THE WIRE WAS FOUND TO BE FIXED. INTRA-CORONARY NITROGLYCERINE WAS ADMINISTERED IN AN ATTEMPT TO FREE THE TIP OF THE WIRE BUT NO SIGNIFICANT CHANGE WAS NOTED. THE BALLOON WAS ADVANCED OVER THE WIRE TO TRY TO WITHDRAW THE WIRE WHEN INSIDE THE BALLOON BUT THIS WAS UNSUCCESSFUL. A THIRD ATTEMPT WAS MADE TO REMOVE THE WIRE THROUGH THE CATHETER AND THIS WAS UNSUCCESSFUL. BECAUSE OF THE SEVERE CORONARY ARTERY DISEASE, THE WIRE BEING STUCK, AND SOME NARROWING IN THE LEFT ANTERIOR DESCENDING ARTERY, THE PHYSICIANS DECIDED TO PERFORM BYPASS SURGERY WITH EXTRACTION OF THE WIRE. PT WAS TRANSFERRED TO THE OPERATING ROOM WHERE SHE UNDERWENT AN EMERGENCY REMOVAL OF IMPACTED PTCA GUIDE WIRE FROM THE POSTERIORLATERAL BRANCH OF THE RIGHT CORONARY ARTERY.
PT IN CATH LAB FOR CORONARY ANGIOPLASTY. DR ATTEMPTED TO ADVANCE A BALLOON TO EXCHANGE THE GUIDE WIRE, DR NOTED THAT THE TIP OF THE WIRE WAS FLOATING LOOSE IN THE MARGINAL BRANCH. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE FREE FLOATING WIRE WITHOUT SUCCESS. THE PT TOLERATED THE PROCEDURE WELL BUT ATTEMPTS AT ANGIOPLASTY WERE ALSO UNSUCCESSFUL. A TEMPORARY PACEMAKER WAS LEFT IN PLACE DUE TO AN EPISODE OF BRADYCARDIA DURING BALLOON INFLATION. OPEN HEART SURGERY WAS ADVISED. ON 12/30/95, DURING CORONARY ARTERY BYPASS GRAFT, AN ATTEMPT WAS MADE TO LOCATE THE BROKEN END OF THE GUIDE WIRE. MD WAS NOT ABLE TO FIND IT AND FELT THAT IT WAS DEEPER IN THE MYOCARDIAL TISSUE.
COULD NOT ASPIRATE FROM PORT. DEVICE REMOVED AND NEW ONE INSERTED.
VENTILATOR STOPPED WORKING WHILE BEING UTILIZED ON A PT. WHEN THE VENTILATOR WENT INOPERABLE, IT COULD NOT BE RESTARTED. THE PT WAS BAGGED  BY THE NURSE AND ANOTHER VENTILATOR WAS BROUGHT IN FOR THE PT.
INFUSOR PUMP WAS SET TO RUN OVER A 30 MINUTE TIME FRAME. THE PUMP INFUSED THE MEDICATION IN ABOUT 3 MINUTES ACCORDING TO THE NURSE. NURSE RAN THE PUMP AT THE NURSE'S STATION WITH NORMAL SALINE AND COULD NOT DUPLICATE THE PROBLEM. THE PUMP WAS BROUGHT TO BIOMEDICAL ENGINEERING FOR EVALUATION. THE PUMP HAS BEEN TESTED AT VARIOUS INFUSION TIMES WITH NO MALFUNCTIONS. THE MFR HAS NEVER SEEN THIS PROBLEM OCCUR WITH ANY OTHER PUMPS.
THIS NON-INJURY REPORT, INVOLVED AN O.R. TABLE WHICH HAD BEEN USED THROUGHOUT THE DAY PRIOR TO THE EVENT WITH NO PROBLEMS. THE MALFUNCTION IS BEST DESCRIBED AS AUTOMATIC, RANDOM, UNCONTROLLED MOVEMENT, AND POSITIONING OF THE TABLE. THE ONLY WAY TO STOP THE TABLE WAS DISCONNECT THE POWER CORD. THIS PROBLEM WAS DUPLICATED, WHEN RPTR POWERED THE TABLE. THE HAND CONTROL WAS REPLACED AND THE TABLE OPERATED AS DESIGNED. THERE HAD BEEN A LOT OF IRRIGATION DURING THIS CASE.
PUMP ALARMING CONTINUOUSLY. SENT NEW PUMP TO PT AND BROUGHT OLD ONE BACK FOR REPAIR. ON 2/5/96 REPAIRMAN STATED PUMP HAD BAD PLUNGER AND MOTOR PROBLEMS. PUMP WILL BE SENT TO MFR WHEN REPLACEMENT PUMP ARRIVES.
A HAIR WAS FOUND IN THE STERILE PACKAGE. PRODUCT WAS NEVER USED.
SALINE PORT BLOCKED. THIS LINE WAS NOT USED. THERE WAS NO PT INVOLVED.
PLASTIC SPIKE ATTACHED TO DRIP CHAMBER APPEARS TO HAVE A BROWN SUBSTANCE STUCK TO IT. CAN'T DETERMINE IF THE PLASTIC BURNED OR IF IT IS A CONTAMINATE.
TIPS BROKE OFF OF END OF SYRINGE FOR NO APPARENT REASON. CONCERN IS THAT TIPS COULD BREAK OFF ON AN INDIVIDUAL'S IV CATHETER REQUIRING CATHETER REPLACEMENT.
SUCTION MACHINE NOT ABLE TO BE USED ON PT WHO ASPIRATED A PIECE OF FOOD, BLOCKING AIRWAY. THE HEIMLICH MANEUVER WAS UNSUCCESSFUL IN OPENING THE AIRWAY. THE SUCTION MACHINE WAS TRIED AND IT WAS UNABLE TO SUCTION PROPERLY DUE TO THE FILTER HOUSING COMING OPEN. IT WOULD NOT STAY LOCKED IN PLACE. AIRWAY WAS CLEARED MANUALLY AND RESCUE BREATHING DONE BY NURSE. PT WAS TRANSPORTED BY AMBULANCE FROM PSYCHIATRIC FACILITY TO A MEDICAL SURGICAL HOSP FOR OBSERVATION AND EVALUATION. PT WAS DISCHARGED FROM HOSP AND WENT TO A NURSING HOME. SUCTION MACHINE CHECKED. FILTER PUT IN PLACE AND SUCTION MACHINE WORKS FINE.
ADDITIONAL INFO PER CALL TO RPTR 3/4/96: RPTR THOUGHT THE INSULATION AROUND THE ELECTRODE HAD BROKEN. PT RECEIVED A VERY SMALL FIRST DEGREE BURN, ABOUT 1 CM. THE BURN WAS TREATED WITH OINTMENT AND IS HEALING WELL.
PUMP WOULD RUN FOR APPROXIMATELY 15 MIN, THEN "E99" MESSAGE WOULD APPEAR ON SCREEN. UNABLE TO CLEAR OR REPROGRAM. PUMP REPLACED.
VENTILATOR CIRCUIT WAS ATTACHED TO SWIVEL CIRCUIT ADAPTER, WHICH WAS ATTACHED TO ENDOTRACHEAL TUBE. WHEN THE CIRCUIT WAS REMOVED TO ALLOW SUCTIONING, SWIVEL ADAPTER FRACTURED AT 15MM OD CONNECTION TO SWIVEL. ONE PIECE OF SWIVEL REMAINED INSIDE THE CIRCUIT ADAPTER AND COULD NOT BE REMOVED. THE ETT ADAPTER WAS REMOVED AND REPLACED WITH AN ADAPTER OFF OF AN UNUSED ETT TUBE. ACTUAL EFFECT ON THE PT IS UNKNOWN. BECAUSE OF THE FRACTURE AND "WEDGING" OF THE PIECE INSIDE THE CIRCUIT AND ON THE ETT, VENTILATION WAS IMPOSSIBLE.
RPTR RECEIVED BREAST IMPLANTS FOR COSMETIC REASONS. SHE HAS BREAST NUMBNESS AND HARDENING OF IMPLANTS. RPTR HAS HAD 8 CLOSED CAPSULOTOMIES. IMPLANTS HAVE RUPTURED. RPTR HAD SURGERY 8/95 TO REMOVE RESIDUAL SILICONE. RPTR ALSO C/O: BLOOD PRESSURE, DEMYELINATING NEUROPATHY, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, CONFUSION, BALANCE DISTURBANCES, ATYPICAL M-S, REDUCED BLOOD FLOW TO BRAIN, BRAIN TUMOR, PAIN AND/OR BURNING SENSATION AND INFLAMMATION OF CHEST, THYROID PROBLEMS, SWELLING, PAIN, DISCOLORATION AND SENSITIVITY OF EXTREMITIES, RAYNAUD'S DISEASE, IRRITABLE BOWEL SYNDROME, HAIR LOSS, HEADACHES, PALPITATIONS, HYPERSENSITIVITY TO CHEMICALS, CONNECTIVE TISSUE DISEASE, LUPUS, SJOGREN'S SYNDROME, ARTHRALGIA, MUSCLE SPASMS, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, RASHES, SUN SENSITIVITY, NON-RESTORATIVE SLEEP, VASCULITIS, CHRONIC FATIGUE SYNDROME, GRANULOMAS AND CLUMSINESS. THE PT HAD RESIDUAL SILICONE REMOVED ON 8/7/95 AND ANOTHER SURGERY ON 9/11/96. BOTH TIMES IN RIGHT BREAST. RIGHT BREAST IS NOW DEFORMED.
EXTREMELY PREMATURE(21 WEEK BY DATE AND BY EXAM, 22 WEEKS BY ULTRASOUND), BABY BORN AT 9:21 A.M. WT. 580 GM. INTUBATED IN DELIVERY ROOM, PLACED IN TRANSPORT ISOLETTE, BAGGED ON THE WAY TO NURSERY. PLACED ON THE RADIANT WARMER BED, WARM WATER BAGS PLACED NEXT TO BABY. PLACED ON VENTILATOR (SETTINGS P22/3 RR 60 FIO2 100% FLOW INSPIRATORY VOL 0.5 SEC AND EXP. 0.5CC) AT 9:30AM. PLACED HUMDIFIER CANISTER WITH HEATER ON. BREATHING CIRCUIT AND MONITOR WERE USED IN CONJUNCTION WITH THE VENTILATOR, AS IS CUSTOMARY IN MOST VENTILATION APPLICATIONS. CARDIAC MONITOR AND PULSE OXIMETRY EQUIPMENT WERE PUT IN PLACE. AT 9:28-PULSE 116, TEMP (RECTAL) 94 DEGREES F. UMBILICAL ARTERY CATHETER BEING INSERTED BY MD BLOOD GASES DRAWN AT 9:37 AND RESPIRATORY THERAPIST TOOK BLOOD FOR TESTING. RT RETURNED WITHIN 1-2 MINUTES JUST AS THE PHYSICIAN NOTED THAT THE BABY'S HEART RATE WAS DROPPING 100-112(APPROX. 9:38AM). THEY OBSERVED THAT THE BABY WAS DUSKY AND THE PHYSICIAN IMMEDIATELY BEGAN TO SUCTION THE ENDOTRACHEAL TUBE AND BAGGED 100% OXYGEN. BABY RECEIVED 1 DOSE OF EPINEPHRINE WITH TRANSIENT RECOVERY OF HEART RATE. AT THE SAME TIME, THE RESPIRATORY THERAPIST NOTICED WATER IN THE VENTILATOR CIRCUIT, DISCONNECTED IT AND DRAINED WATER FROM TUBING THROUGH THE WATER TRAPS. RT RECONNECTED THE CIRCUIT TO THE BABY AND NOTED, INSTANTANEOUSLY, THAT THE VENTILATOR AND HUMIDIFIER CIRCUIT HAD WATER, HOWEVER, NO ALARM WAS SOUNDED BY THE HUMIDIFIER. MD IMMEDIATELT DISCONNECTED TUBING FROM BABY, AND BAGGED THE BABY. BLOODY FLUID WAS SUCTIONED FROM THE BABY, CPR STARTED, CHEST COMPRESSIONS AND EPINEPHRINE X 2 DOSES THROUGH CENTRAL LINE. BAGGED WITH AMBU AND PIP OF 32 REQUIRED FOR CHEST MOVEMENT. CPR CONTINUED. BABY PRONOUNCED AT 10:08 AM. PARENTS REFUSED AUTOPSY.
PT WAS REFERRED FOR EXTRACTION OF A FRACTURED LEAD. AFTER PREPPING PT IN USUAL FASHION, AN INCISION WAS MADE FROM THE MID-THIRD OF THE CLAVICLE TO THE DELTO PECTORAL GROOVE. THE OLD PACEMAKER GENERATOR WAS EXPOSED, ALONG WITH THE RETAINED REMNANT OF THE FRACTURED LEAD. A PORTION OF LEAD HAD FRCTURED AND WAS RETAINED IN THE MEDIASTINUM. THE REMAINING REMNANT WAS REMOVED WITHOUT PROCEDURE RELATED COMPLICATIONS AND REPLACED.
PT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY DURING 1988 AND REVISION DURING 1991. TYPE OF REVISION SURGERY UNKNOWN. DUAL LOCK POROUS-COATED BIPOLAR PROSTHESIS AND AN ACETABULOPLASTY WAS PERFORMED DURING 1991. RADIOGRAPHS TAKEN DURING 1990 REVEALED MEDIAL AND CEPHALAD MIGRATION OF THE BIPOLAR CUP AND RADIOLUCENCY AROUND THE DISTAL END OF THE STEM, WHICH WAS FELT TO BE ATTRIBUTED TO EITHER PROGRESSIVE ACETABULAR DISEASE OR COMPONENT LOOSENING. A BONE SCAN PERFORMED 6/1/95 REVEALED INTENSE ACTIVITY NOTED ALONG THE MEDIAL PORTION OF THE MID LEFT FEMUR, AT THE DISTAL STEM OF THE FEMORAL PROSTHESIS. THE PT WAS ADMITTED TO THE HOSP FOR REVISION OF THE LEFT HIP DUE TO INCREASED HIP PAIN, DECREASED MOBILITY, AND "STINGING" TYPE PAIN OF THE LARGE TOE WITH NUMBNESS. INFECTION WAS RULED OUT BY INTRAOP CULTURE RESULTS. THE FEMORAL COMPONENT WAS LOOSENED.
PT WAS REFERRED TO THIS INSTITUTION FOR ICD GENERATOR CHANGE. THE EXISTING ICD WAS EXPLANTED VIA AN INCISION OVER THE GENERATOR POCKET. TESTING OF THE EXISTING LEAD REVEALED LOW PACING IMPEDENCE. INSPECTION OF THE LEAD IN THE POCKET REVEALED MULTIPLE ABRASIONS ON THE SENSING AND DEFIBRILLATING COIL INSULATION. THE SENSING LEAD INSULATION WAS WORN OUT IN PLACES WITH EXTRUSION OF THE CONDUCTOR COIL. BECAUSE OF THE DEFECTS INVOLVING THE DEFIBRILLATOR SEGMENT OF THE LEAD AS WELL, IT WAS DECIDED TO CHANGE THE ENTIRE LEAD.
PT UNDERWENT INITIAL PLACEMENT OF RIGHT TOTAL HIP ARTHROPLASTY DURING 1/95. PT SUBSEQUENTLY SUSTAINED SEVEN DISLOCATIONS PRIOR TO HOSP ADMISSION FOR TOTAL HIP REVISION. PT WAS STANDING WHEN A "POP" WAS FELT IN THE RIGHT HIP. THE PROSTHESIS WAS FOUND TO BE DISLOCATED ANTERIORLY. INTRAOPERATIVE FINDINGS INCLUDED REDUNDANT PSEUDOCAPSULE ANTERIORLY. IT WAS FELT STABILITY OF THE PROSTHESIS COULD BE ACCOMPLISHED BY LEVERING THE ACCENTUATED ANTERIOR LIP. THE C-TAPER HEAD AND ACETABULAR INSERT WERE REPLACED. THE ACETABULAR INSERT WAS MOVED FROM AN 11:00 POSITION TO A 3:30 POSITION. A +5 HEAD WAS INSERTED. INTRAOPERATIVE CULTURES WERE OBTAINED WHICH WERE REPORTED AS NEGATIVE FOR AEROBIC OR ANAEROBIC GROWTH.
PT HAS HISTORY OF PRIMARY OSTEOARTHRITIS AND SUBSEQUENTLY UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES DURING THE 1980'S. THE LEFT HIP WAS REVISED DURING 1992. PT PRESENTED TO THE ER AFTER BENDING AND SUSTAINING A DISLOCATION TO THE HIP. THE HIP WAS REDUCED IN THE ER BUT POST-REDUCTION RADIOGRAPHS REVEALED "SOMETHING INTERPOSED" BETWEEN THE FEMORAL HEAD AND THE ACETABULAR COMPONENT. THE PT WAS ADMITTED TO THE HOSP AND TAKEN TO THE OR THE FOLLOWING DAY FOR REVISION OF THE LEFT HIP PROSTHESIS. A HEMATOMA, WHICH DID NOT APPEAR INFECTED, WAS FOUND INTRAOPERATIVELY AROUND THE IMPLANTS. CULTURES WERE OBTAINED AND REPORTED AS NEGATIVE. DEFORMATION OF THE POSTERIOR ASPECT OF THE ACETABULAR CUP WAS ENCOUNTERED. THE BURSA SURROUNDING THE IMPLANT WAS EXCISED. THE FEMORAL HEAD/NECK AND ACETABULAR LINER WERE REPLACED.
PT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DURING 1989. PT PRESENTED TO THE HOSP WITH COMPLAINTS OF PAIN AND EFFUSION OF THE LEFT KNEE. THE KNEE WAS ASPIRATED AND CULTURES WERE OBTAINED WHICH WERE FOUND TO BE NEGATIVE FOR ORGANISM GROWTH. THE PT REPORTED SENSATIONS OF "POPPING" AND "GRINDING" OF THE KNEE. CHRONIC SYNOVITIS WAS PRESENT. PT WAS ADMITTED FOR TOTAL KNEE REVISION. INTRA-OPERATIVE FINDINGS WERE SIGNIFICANT FOR FRAGMENTATION OF THE 7 MM TIBIAL BEARING INSERT. IT WAS WORN MEDIALLY AND POSTERIORLY. MEDIUM-SIZED TIBIA WAS PLACED. METHYL METHACRYLATE WAS PRESSURIZED INTO THE TIBIAL PLATEAU. A 9 MM SERIES TIBIAL BEARING INSERT WAS LOCKED INTO PLACE WITH A LOCKING SCREW. A SYNOVECTOMY OF THE KNEE WAS ALSO PERFORMED.
PT ORIGINALLY UNDERWENT IMPLANTATION OF A DEFIBRILLATOR SYSTEM IN 1/93 BECAUSE OF SYNCOPE ASSOCIATED WITH RAPID VENTRICULAR TACHYCARDIA. SUBSEQUENTLY LEAD REVISION WAS PERFORMED IN 9/93 BECAUSE OF INSULATION DEFECT IN ABDOMINAL POCKET CAUSING SPURIOUS SHOCKS. THIS LEAD WAS REPAIRED BUT PT WAS READMITTED IN 3/94 WITH RECURRENT SPURIOUS ICD DISCHARGES RELATED TO BODY POSTURE AND ORIGINAL LEAD WAS THEN EXPLANTED ON 3/3/94 AND REPLACED WITH A NEW LEAD. DEFIBRILLATION THRESHOLD WAS 20 JOULES WITH A SUBCUTANEOUS PATCH INCORPORATED IN DEFIBRILLATION CIRCUIT. AT TIME OF ROUTINE TESTING IN 5/94 IT WAS NOTICED THAT LEAD HAD BECOME DISLODGED FROM RIGHT VENTRICULAR APEX AND LEAD WAS REPOSITIONED. DEFIBRILLATION THRESHOLD WAS 25 JOULES ++ AT THAT TIME. SINCE 5/94 PT HAS BEEN WELL AND ACTIVE. PT HAS HAD ARRHYTHMIA DETECTIONS AND ELECTROGRAM EVIDENCE OF RAPID VENTRICULAR TACHYCARDIA. AT TIME OF ROUTINE DEFIBRILLATOR EVALUATION IT WAS NOTED THAT PACING IMPEDANCE HAD RISEN TO > 2000 OHMS AND THAT A NUMBER OF APPARENTLY SPURIOUS DETECTIONS HAD OCCURRED IN WHICH INTRACARDIAC ELECTROGRAM DEMONSTRATED NORMAL SINUS RHYTHM ON SHOCKING ELECTRODES AT TIME WHEN DEVICE WAS INDICATING HEART RATE WAS IN EXCESS OF 300 BEATS PER MINUTE. OVERSENSING COULD BE REPRODUCED BY MANIPULATION OF DEVICE IN ABDOMINAL POCKET, SUGGESTING A RECURRENT FRACTURE ON RATE SENSING CIRCUIT. PT WAS THEREFORE ADMITTED FOR EXPLANTATION OF SYSTEM. PT WAS PREPPED IN USUAL FASHION UNDER GENERAL ANESTHESIA. ABDOMINAL POCKET WAS OPENED AND DEVICE EXPLANTED. LEADS WERE FOUND TO BE WELL SEATED IN HEADER OF DEVICE AND BOTH OVERSENSING AND UNDERSENSING COULD BE REPRODUCED BY MANIPULATION OF RATE SENSING PORTION BETWEEN YOKE OF LEAD AND TERMINAL PINS OF RATE SENSING CIRCUIT. DEFIBRILLATION THRESHOLD WAS MEASURED USING LEAD, HAVING EXCLUDED SUBCUTANEOUS PATCH FROM DEFIBRILLATION CIRCUIT. DEFIBRILLATION THRESHOLD WAS 18 JOULES USING BIPHASIC WAVEFORM. FOLLOWING THIS MEASUREMENT, ATTENTION WAS TURNED TO CHEST WALL AND SUBCUTANEOUS PATCH INCISION WAS OPENED. LABORIOUS DISSECTION WAS PERFORMED IN ORDER TO REMOVE SUBCUTANEOUS PATCH WHICH HAD DISINTEGRATED. PIECES OF METAL BRAIDING WERE EMBEDDED WITHIN SCAR TISSUE AND HAD TO BE REMOVED PIECE MEAL. EVENTUALLY THIS PATCH WAS SUCCESSFULLY REMOVED. PECTORAL WOUND WAS THEN OPENED AND LEAD TRANSECTED IN ABDOMINAL POCKET. LEAD WAS BROUGHT UP THROUGH SUBCUTANEOUS TUNNEL AND THEN ANCHORING SLEEVES WERE DIVIDED AND REMOVED. ATTEMPTS WERE THEN MADE TO REMOVE LEAD USING LOCKING STYLET. DURING REMOVAL PROCESS LEAD DISINTEGRATED LEAVING ONLY TERMINAL ELECTRODE ATTACHED TO AN APPROX 6 CM LONG PIECE OF EXPOSED CONDUCTOR TINES AND BOTH COILS WAS REMOVED WHOLE THROUGH SUBCLAVIAN VEIN. INITIALLY, ATTEMPTS WERE MADE FROM RIGHT FEMORAL VEIN USING A SWARTZ SHEATH AND BIOPTOME TO REMOVE REMAINING PORTION OF LEAD IN RIGHT VENTRICLE. THIS WAS UNSUCCESSFUL. AN 8 FR SHEATH WAS THEN PLACED IN LEFT SUBCLAVIAN VEIN AND A GOOSE NECK SNARE WAS USED TO SNARE FREE FLOATING PORTION OF RETAINED WIRE.
THE PT WAS REFERRED FOR PACEMAKER REVISION BECAUSE OF A FRACTURE OF THE ATRIAL LEAD RETENTION WIRE. THIS FRACTURE WAS NOTED IN 3/95 WITHOUT PROTRUSION OF THE WIRE. ON 8/23/95 THE ATRIAL LEAD WAS REMOVED USING A LOCKING WIRE AND 8.5 DILATING SHEATH. THE LEAD WAS REMOVED IN PIECES, HOWEVER THE RETENTION WIRE WAS NOTED TO BE BROKEN IN TWO PLACES WITH OLD BLOOD STAINING THE INTERIOR OF THE INSULATION. ONE END OF THE WIRE WAS PERFORATING THE INSULATION JUST PROXIMAL TO THE SECOND ELECTRODE. A NEW ATRIAL LEAD WAS INSERTED WITHOUT PROBLEMS.
PT WAS REFERRED TO CARDIAC ELECTROPHYSIOLOGY LAB FOR ROUTINE ICD GENERATOR CHANGE. DEVICE WAS EXPLANTED WITHOUT DIFFICULTY, HOWEVER INSULATION OF EXPLANTED LEAD WAS OBSERVED TO BE FRACTURED.
PT HAS PAST MEDICAL HISTORY OF CONGENITAL DYSPLASIA OF THE RIGHT HIP. AN OSTEOTOMY OF THE RIGHT HIP WAS PERFORMED WHEN THE PT WAS AGE 6, WHICH WAS CONVERTED TO A RIGHT TOTAL HIP ARTHROPLASTY IN 1988. THE PT DID WELL FOLLOWING TOTAL HIP REPLACEMENT UNTIL PT BEGAN TO HAVE RIGHT THIGH AND HIP PAIN APPROX TWO TO THREE YEARS AGO. BONE SCAN AND PREOPERATIVE RADIOGRAPHS REVEALED LOOSENING OF THE FEMORAL STEM. THE STEM WAS NOT CEMENTED. THE PT WAS TAKEN TO SURGERY WHERE THE FEMORAL PROSTHESIS, LINER, AND HEAD WERE REPLACED. EVIDENCE OF WEAR OF THE ACETABULAR LINER WAS IDENTIFIED INTRAOPERATIVELY. A SIZE 9 FEMORAL STEM WAS CEMENTED WITH A 0+ NECK AND 28MM HEAD. CALCAR DEFICIENCY WAS FOUND AND WAS REINFORCED WITH POLYMETHYLMETHACRYLATE CEMENT. EVIDENCE OF GROSS LOOSENING OF THE FEMORAL COMPONENT WAS FOUND. INTRAOPERATIVE CULTURES WERE REPORTED AS NEGATIVE.
PT WAS REFERRED TO CARDIAC ELECTROPHYSIOLOGY LABORATORY WITH AN ATRIAL LEAD FRACTURE AND FATIGUE. THE OLD GENERATOR WAS EXPLANTED AND THE ATRIAL LEAD DISCONNECTED. THE LEAD WAS FOUND TO HAVE FRACTURE AND AN INSULATION BREAK. THE LEAD WAS EASILY UNSCREWED AND REMOVED. A NEW LEAD WAS IMPLANTED AND TESTED WITHOUT COMPLICATIONS OR PROBLEMS.
PT HAD ATRIAL LEAD PERFORATION BY FLUOROSCOPY AND WAS REFERRED TO ELECTROPHYSIOLOGY LABORATORY FOR LEAD EXTRACION. THE OLD GENERATOR WAS EXTRACTED AND THE ATRIAL LEAD WAS DISCONNECTED. AN EXTRACTION WAS USED TO PULL OUT THE LEAD, WHICH WAS NOTED TO HAVE (2) J PERFORATIONS. A NEW LEAD WAS PLACED AND TESTED WITHOUT PROBLEM.
PT UNDERWENT LEFT TOTAL HIP REPLACEMENT ON 8/4/92. PT PRESENTED TO MD FOR ROUTINE FOLLOW-UP. RADIOGRAPHS REVEALED A DISLODGED ACETABULAR LINER. ON 11/16/95 PT UNDERWENT REVISION OF THE ACETABULAR COMPONENT WITH EXCHANGE OF FEMORAL HEAD COMPONENT.
PT WAS REFERRED TO ELECTROPHYSIOLOGY LABORATORY FOR AN ATRIAL LEAD EXTRACTION. DURING THIS PROCEDURE A J WIRE WAS PLACED INTO THE VASCULATURE AND THE PEEL-AWAY SHEATH PLACED OVER THE WIRE. THE NEW ATRIAL LEAD WAS ADVANCED THROUGH THE SHEATH. WHEN ATTEMPTING TO REMOVE THE SHEATH BY PULLING TABS APART, A PORTION OF THE SHEATH REMAINED IN THE VASCULATURE. PHYSICIAN ATTEMPTED TO REMOVE SHEATH BY REPEATEDLY PULLING ON TAB. APPROX 2/3 OF SHEATH WAS FREED WHEN PIECES SNAPPED. FLUOROSCOPY SHOWED THAT PIECES OF SHEATH REMAINED IN PLACE, HOOKED ON THE J PORTION OF THE WIRE. THIS MATERIAL WAS FINALLY EXTRACTED WITH A GOOSE-NECK CATHETER INTRODUCED INTO THE RFV. ATRIAL REPLACEMENT THEN CONTINUED WITHOUT EVENT.
THE INSULATED HYSTERSCOPY SHEATH TIP BROKE OFF WHEN REMOVING SPECIMEN FROM THE DISTAL END.
PT WAS REFERRED TO ELECTROPHYSIOLOGY LAB FOR ATRIAL LEAD REVISION DUE TO LEAD MIGRATION TO THE RIGHT VENTRICLE. A 52 CM STYLET WAS ADVANCED IN THE ATRIAL LEAD AFTER THE LEAD WAS UNSCREWED FROM THE PULSE GENERATOR. THE ATRIAL LEAD WAS REPOSITIONED IN THE RIGHT ATRIUM BUT SATISFACTORY PACING PARAMETERS WERE NOT OBTAINED. THIS APPEARED TO BE DUE TO A BROKEN SCREW AT TIP OF ELECTRODE. A NEW ATRIAL LEAD WAS REPOSITIONED IN THE RIGHT ATRIUM AND TESTED. THE SCREW AT THE TIP OF THE ATRIAL LEAD WHICH BROKE OFF REMAINS EMBEDDED IN LATERAL RIGHT ATRIAL WALL.
AFTER THE COMPRESSION DEVICE WAS USED THERE WERE SLIGHT SIGNS OF INJURY TO 2 DIFFERENT PATIENTS. ONE PATIENT HAD A 3CM CIRCLE BRUISE. THE OTHER PATIENT HAD A 3 INCH CIRCLE BLISTER.
DURING A PROCEDURE A RING FELL OFF OF A 10MM TROCAR AND FELL INTO THE PT'S ABDOMEN.
MONITOR ALARM DID NOT ALARM FOR VENTRICULAR FIBRILLATION.
CRANIAL PERFORATOR DID NOT STOP SPINNING WHEN IT PASSED THROUGH THE BONE.
PT WAS HAVING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE. AFTER THE UMBILICAL PUNCTURE WAS MADE AND THE OBTURATOR WAS REMOVED, A LARGE AMOUNT OF BLOOD WAS NOTED. THE PHYSICIAN NOTED THAT THE SHARP POINT PASSED THE SAFETY GUARD ON THE TROCAR. THE PT'S LEFT ILIAC ARTERY WAS PUNCTURED. IMMEDIATE SURGICAL REPAIR WAS REQUIRED. THE PT RECOVERED WITH NO ADVERSE EFFECTS OTHER THAN THE SCAR FROM SURGERY.
ON 8/8/95 A PT (UNDERGOING A TONSILLECTOMY) WAS BURNED WHEN A GAUZE PAD IGNITED IN THE PTS MOUTH. AN ESU WAS BEING USED AT THE TIME OF THE INCIDENT. HOSP SUSPECTS THAT PIECE OF EQUIPMENT MAY HAVE CONTRIBUTED TO THE INCIDENT.
A FEEDING TUBE WAS BEING INSERTED AND THE STAFF WAS UNABLE TO GET THE GUIDE WIRE OUT. THE ENTIRE TUBE HAD TO BE REMOVED FROM THE PT AND THE "BLUE" TIP CAME OFF OF THE GUIDE WIRE.
ON 8/14/95 A PT (UNDERGOING A THORACTOMY) WAS BURNED WHEN A SURGICAL SPONGE IGNITED IN THE CHEST CAVITY. AN ESU WAS BEING USED AT THE TIME OF THE INCIDENT. HOSP SUSPECTS THAT THIS PIECE OF EQUIPMENT MAY HAVE CONTRIBUTED TO THE INCIDENT.
DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE WAS INFLATED AND BURST.
VAPORIZER QUIT DISPENSING ANESTHETIC AGENT TO PT WHO WOKE UP DURING CAROTID ENDARTERECTOMY. NO INJURY OCCURRED TO PT, HOWEVER, AS ANESTHESIOLOGIST TRANSFERRED PT IMMEDIATELY TO ANOTHER ANESTHETIC VAPORIZER. PT OUTCOME WAS NOT COMPROMISED.
VAPORIZER DID NOT DISPENSE ANESTHETIC AGENT. NO PT INVOLVEMENT SINCE PT HAD NOT BEEN PLACED UNDER ANESTHETIC WHEN FAILURE WAS NOTICED.
DURING BLOOD TRANSFUSION. ANESTHESIOLOGIST REPORTED THAT THERE WERE AIR BUBBLES PRESENT IN THE TUBING CASSETTE. NO PT INJURY RESULTED, HOWEVER NURSE INDICATED THAT THE TUBING HAD BEEN CORRECTLY PRIMED PRIOR TO USE.
IMPLANTED AND CATHETER BROKE OFF IN PT & HAD TO BE SURGICALLY REMOVED.
PT HAD A LEFT UPPER LOBECTOMY FOR LUNG CANCER ON 5/24/95. ABOUT 4 WEEKS AGO, PT EXPERIENCED INCREASED PAIN IN THE LEFT SIDE. CHEST X-RAY REVEALED A FRACTURE IN 2 WIRES THAT WERE USED TO STABILIZE THE RIB CAGE AFTER LOBECTOMY. CONSERVATIVE TREATMENT OF MEDICATION AND INTERCOSTAL NERVE BLOCKS FAILED. SURGERY WAS DONE THEN ON 7/12/95 TO REMOVE THE FRACTURED WIRES. THE SURGEON DISCARDED THE WIRES.
PT WAS LAST DIALYZED 7/31/95. CLOTTED ACCESS NOTED 8/2/95. REMOVAL OF PORTION OF GRAFT THAT WAS BLOCKED, HARD TO TOUCH. NOTED RING-LIKE THREAD FIBERS AROUND PORTION OF GRAFT. SENT TO PATHOLOGY WITH CLOT.
AICD IMPLANTED 6/2/95. RECEIVED 1 SHOCK 1 WEEK BEFORE EVENT. ON DATE OF EVENT, PT REPORTED RECEIVING 10 SHOCKS AND WAS UNAWARE OF PALPITATIONS OR SUBJECTIVE TACHYCARDIA.
PT HAD AORTIC VALVE REPLACED IN 1990 DUE TO AORTIC STENOSIS. PT WAS SEEN SEVERAL WEEKS AGO ON OUTPATIENT BASIS AND ALTHOUGH ASYMPTOMATIC WAS FOUND TO HAVE PROMINENT MURMUR OF AORTIC INSUFFICIENCY. THIS WAS DUE TO DEGENERATION OF AORTIC VALVE PROSTHESIS.
THIS 50-YEAR-OLD FEMALE HAD PREVIOUS BILATERAL MASTECTOMIES AND STAGE I BREAST RECONSTRUCTION. THE SECOND SET OF BREAST TISSUE EXPANDERS WAS IMPLANTED 9/14/94. WITHIN THE LAST SEVERAL DAYS PRIOR TO THIS ADMISSION, PT NOTED AN ABRUPT DECREASE IN VOLUME ON THE LEFT SIDE. SHE HAD BEEN SCHEDULED FOR STAGE II RECONSTRUCTION, BUT THE TIME WAS MOVED UP IN ORDER TO NOT LOOSE THE EXPANSION. GROSS EXAM: AT THE MARGIN OF THE LEFT TISSUE EXPANDER IS A SMALL PURPLE RING IN THE CENTER OF WHICH IS A PUNCTURE FENESTRATION. SURGEON QUESTIONS STRUCTURAL WEAKNESS OR FATIGUE AT THE EXACT EDGE OF THE EXPANDER ITSELF. THE RIGHT EXPANDER WAS INTACT.
THIS 39-YEAR-OLD FEMALE UNDERWENT A BAM ON 9/3/95 UTILIZING SALINE IMPLANTS WITH FILLING VALVES. ABOUT 2 MONTHS AGO, SHE NOTED HER RIGHT BREAST WAS LARGER THAN THE LEFT. AT THE TIME OF SURGERY, THE FILLING TUBE WAS WITHDRAWN AND FOUND TO BE QUITE CONVOLUTED AND TWISTED. IT WAS MANIPULATED, THEN POPPED. IT APPEARS TO FRACTURE AT THE PERFORATION POINT ALONG THE TUBE. THERE WAS NO EVIDENCE OF IMPLANT LEAKAGE.
THIS 54-YEAR-OLD FEMALE UNDERWENT A BAM IN 1969 WITH IMPLANTATION OF SILICONE GEL BREAST IMPLANTS. AS THE PROCEDURE WAS NOT PERFORMED AT THIS REPORTING FACILITY, THE SPECIFIC IDENTIFIERS OF THE DEVICE ARE UNKNOWN. OVER THE YEARS, THE PT STATES SHE HAS DEVELOPED NUMEROUS SYSTEMIC PROBLEMS, INCLUDING ATYPICAL MIXED CONNECTIVE TISSUE DISEASE, AS WELL AS CHEST WALL PAIN. GROSS EXAM: BOTH IMPLANTS ARE DISRUPTED AND EXUDE A STICKY, STRINGY, GELATINOUS MATERIAL.
INSTRUMENT SET AT 3CC/HR, CASSETTE AND TUBING APPEARED TO BE LOADED CORRECTLY BUT WAS DELIVERING FLUID AT GREATER RATE THAN SET RATE; NURSES STOPPED INFUSION ALMOST IMMEDIATELY BEFORE ANY ALARM SOUNDED, SENT TO MFR FOR EXAMINATION OF PROBLEM. FIRST INCIDENT WITH SAME INSTRUMENT DID NOT ALARM FOR 1 1/2 HOURS. DID NOT SHOW CORRECT VOLUME INFUSED.
PUMP CEASED PUMPING, ALARM READ IAB DISCONNECTED, GAS LOSS DETECTED. ON OBSERVATION OF TUBING, NO GAS LOSS OR DISCONNECTION WAS FOUND - CONTINUING PROBLEMS WITH FUNCTIONING BUT WAS ABLE TO "GET BY". BALLOON REMOVED AND STAFF QUESTIONED PROBLEM WITH CATHETER SINCE CHANGING PUMPS DID NOT CORRECT PROBLEM.
THIS 33-YEAR-OLD FEMALE UNDERWENT A BAM IN 1984 USING SUBGLANDULAR SILICONE GEL IMPLANTS. THE PT COMPLAINS OF MEMORY LOSS, HAIR LOSS, FATIGUE, AND NEUROPATHY OF EXTREMITIES. GROSS EXAM: POSSIBLE FENESTRATION AT TIME OF SURGERY DUE TO NO EVIDENCE OF STICKY COATING ON OUTER ASPECT OF THE IMPLANTS IN THE AREAS REMOTE FROM FENESTRATION.
DR TRIED TO FILL SALINE IMPLANT AND IT WOULD NOT WORK, SO DR TRIED TUBING FROM ANOTHER IMPLANT. IT STILL WOULDN'T WORK. THE VALVE ON THE IMPLANT WAS DEFECTIVE, SO TWO IMPLANTS WERE WASTED ON THIS CASE.
THIS 49-YEAR-OLD FEMALE HAD BREAST RECONSTRUCTION IN 6/90 WITH INSERTION OF A DOUBLE LUMEN SALINE/SILICONE BREAST EXPANDER. THIS PROCEDURE WAS PERFORMED AT ANOTHER FACILITY, THUS THIS REPORTING FACILITY DOES NOT HAVE ACCESS TO DEVICE IDENTIFIERS. DUE TO PTOSIS OF THE RIGHT BREAST, POSITIVE ECHOSONOGRAMS, AND THE CONTROVERSY RELATING TO SILICONE BREAST IMPLANTS, THE PT CHOSE TO HAVE THEN REMOVED. GROSS EXAM: FOCALLY, THE SAC SHOWS SLIT-LIKE FENESTRATIONS AND THE COLLAPSED SAC IS COVERED WITH STICKY, STRINGY, GELATINOUS SUBSTANCE.
DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TO RIGHT CORONARY ARTERY DEVICE WAS INFLATED TO 13 ATM WHEN BALLOON LOST PRESSURE AS IF BALLOON HAD RUPTURED. MAXIMUM RATED BURST PRESSURE FOR THIS BALLOON IS 8 ATM. THIS WAS 3RD INFLATION WITH PREVIOUS INFLATIONS AT 12 ATM FOR 2 MINS 30 SECS AND 13 ATM FOR 2 MINS. DISTAL PORTION OF BALLOON APPEARED TO BE INFLATED. AFTER HAND INFLATION DEVICE LOST PRESSURE. A LARGE SYRINGE WAS USED TO ASPIRATE BALLOON CATHETER WITH BLOOD RETURNED. DIFFICULTY WAS ENCOUNTERED. CARDIOLOGIST ATTEMPTED TO REMOVE BALLOON CATHETER. CATHETER WAS ADVANCED FURTHER DOWN RIGHT CORONARY WITHOUT DIFFICULTY. MORE EFFORT THAN USUAL WAS REQUIRED TO EXTRACT CATHETER FROM CORONARY ARTERY. WHEN CATHETER WAS REMOVED FROM PT, DISTAL HALF OF BALLOON WAS MISSING. A FILLING DEFECT WAS NOTED DISTAL TO LESION AND SATISFACTORY DILATION OF RIGHT CORONARY NOT OBTAINED. PT SENT TO OR FROM CATH LAB FOR CABG. RETRIEVAL OF MISSING BALLOON SEGMENT BY SURGEONS WAS UNSUCCESSFUL - CORONARY GRAFTING DONE.
THIS 37-YEAR-OLD FEMALE UNDERWENT A BAM WITH SILICONE GEL IMPLANTS IN 1991. THE PROCEDURE WAS PERFORMED AT ANOTHER FACILITY, THEREFORE THE DEVICE IDENTIFIERS ARE NOT KNOWN. THE PT RECENTLY SAW SOME DIMINUTION IN THE OVERALL SIZE OF THE RIGHT BREAST AND A MAMMOGRAM WAS SUSPICIOUS OF A RIGHT RUPTURED IMPLANT. GROSS EXAM: THE RIGHT IMPLANT IS MASSIVELY RUPTURED.
RN UNABLE TO REMOVE CATHETER. PT SENT TO ER FOR REMOVAL. ER INSERTED A STENT. BALLOON WAS DEFLATED AND A NEW CATHETER WAS INSERTED WITHOUT DIFFICULTY.
THIS 55-YEAR-OLD FEMALE UNDERWENT BAM WITH SILICONE GEL BREAST IMPLANTS IN 1977. AS THE PROCEDURE WAS PERFORMED AT ANOTHER FACILITY, THIS REPORTING FACILITY DOES NOT HAVE ACCESS TO THE DEVICE IDENTIFIERS. THE PT COMPLAINS OF SEVERE JOINT PAIN, DEPRESSION, FATIGUE, PANIC ATTACKS, AND BREAST LUMPS, THEREFORE, CHOOSES TO HAVE THE IMPLANTS REMOVED. GROSS EXAM: BOTH IMPLANTS ARE RUPTURED AND EXUDE GELATINOUS AND TENACIOUS MATERIAL. BOTH CAPSULES ARE FIBROUS WITH MARKED FOAMY MACROPHAGE AND FOREIGN BODY GIANTS CELL REACTION ASSOCIATED WITH FOREIGN MATERIAL.
WHEN ATTEMPTING TO PLACE THE STENT ACROSS A COMMON ILIAC ARTERY STENOSIS, THE STENT BECAME DISLODGED FROM THE DELIVERY BALLOON AND HAD TO BE DEPLOYED IN THE EXTERNAL ILIAC ARTERY. A SECOND STENT HAD A SIMILAR PROBLEM AND WAS SUCCESSFULLY REMOVED FROM THE PT. THE PT SUBSEQUENTLY DEVELOPED A RETROPERITONEAL HEMATOMA.
THIS 31-YEAR-OLD FEMALE UNDERWENT A BAM WITH SALINE IMPLANTS ON 6/3/93. THE PT NOW PRESENTS WITH SIGNS OF A LEAKING IMPLANT. GROSS: THE RIGHT SALINE IMPLANT HAS A 0.2 CM SLIT-LIKE FENESTRATION WHICH IS LOCATED 4.9 CM FROM THE INJECTION PORT OPENING. THE LEFT IMPLANT IS EMPTY WITH A LARGE (5 X 2.5 CM) OVAL FENESTRATION, PROBABLY RESULTING DURING SURGERY AS IT APPEARS SHARPLY AND FRESHLY CUT IN THE WALL.
THIS 34-YEAR-OLD FEMALE WITH A HISTORY OF RHEUMATIC HEART DISEASE, HAD THE SECOND MITRAL VALVE REPLACEMENT IN 1982. THE DEVICE SPECIFICATIONS ARE NOT KNOWN TO THIS REPORTING FACILITY. THE PT HAS EXPERIENCED INCREASING EPISODES OF INTERMITTENT ATRIAL FIBRILLATION RELATED TO SEVERE MITRAL REGURGITATION AND SEVERE PULMONARY HYPERTENSION. THE PROSTHETIC MITRAL VALVE WAS CALCIFIED AND HAD A TEAR IN ONE OF THE LEAFLETS. GROSS DESCRIPTION: VALVE STRUTS ARE INTACT, SMALL AMOUNT OF FIBRINOUS TISSUE ADHERANT TO THE WOVEN FABRIC AROUND THE VALVE SEAT, SMALL AMOUNTS OF CALCIFICATION WITH NO GROSS EVIDENCE OF VEGATATIONS.
THIS 70-YEAR-OLD MALE HAD A SELF-CONTAINED PENILE PROSTHESIS IMPLANTED 5/21/91 FOR ERUCTILE DYSFUNCTION POST RADICAL PROSTATECTOMY. HE PRESENTS WITH REPORTED FAILURE OF THE PROSTHESIS TO FUNCTION. THE DEVICE WAS RETURNED TO CO FOR FURTHER EVALUATION ON ABOUT 10/5/95.
AFTER A GUIDE WIRE WAS PLACED THROUGH ENDOSCOPE INTO STOMACH, THE ENDOSCOPE WAS RETRACTED AND BOTH WERE LEFT IN PLACE. THEN A DILATOR WITH CLEAR OVERTUBE OVER DILATOR WAS PLACED WITHOUT DIFFICULTY. A VARIX WAS BANDED. SUBSEQUENTLY, UPON RETRACTION OF THE ENDOSCOPE AND OVERTUBE, PROFUSE BLEEDING FROM POSTERIOR PHARYNX WAS NOTED. A REPEAT EGD REVEALED A SUPERFICIAL ESOPHAGEAL MUCOSAL TEAR/LACERATION.
PT BECAME FLUID OVERLOADED, POST RED CELL EXCHANGE, DUE TO SOFTWARE PROBLEM THAT ALLOWS FLUID OVERLOAD DURING COMBINATIONS OF RUN CONDITIONS. CO HAD SENT WARNING NOTIFICATION OF PROBLEM, BUT IT WAS ADDRESSED INCORRECTLY AND NEVER RECEIVED BY USER DEPARTMENT.
THIS 37-YEAR-OLD FEMALE UNDERWENT A BAM WITH SALINE-FILLED BREAST IMPLANTS ON 4/15/93. RECENTLY THE RIGHT IMPLANT SUDDENLY COMPLETELY DEFLATED. GROSS EXAM: THE EMPTY RIGHT IMPLANT SHOWS A MINUTE PIN-POINT HOLE IN THE LATERAL ASPECT THROUGH WHICH, WHEN INFLATED, WATER FLOWS SLOWLY DROP BY DROP. THE LEFT IMPLANT IS ALSO EMPTY WITH A 0.7CM SLIT-LIKE FENESTRATION WHICH OCCURRED DURING EXPLANATION.
REPLACEMENT OF RIGHT BREAST IMPLANT DUE TO CAPSULAR CONTRACTURE. IMPLANT WAS INTACT.
REPLACEMENT OF LEFT BREAST IMPLANT DUE TO DEFLATION. IMPLANT WAS INTACT.
CAPSULAR CONTRACTURE, DEFORMITY AND TENDERNESS OF RIGHT BREAST. CAPSULECTOMY PERFORMED AND RIGHT IMPLANT REPLACED. IMPLANT REMOVED WAS INTACT.
THIS 48-YEAR-OLD MALE, WHO A NUMBER OF YEARS AGO HAD A PENILE PROSTHESIS PLACED. IN 11/90, HE HAD REVISION AND HE, AGAIN, NOW HAS AN UNINFLATABLE PROSTHESIS. IT WAS DETERMINED THERE WAS A FAILED PROSTHESIS. THERE WAS A DENSE INFLAMMATORY RIND AROUND ALL THE TUBING WHICH APPEARS TO HAVE SOME KINKING. ONCE THE TUBING WAS FREED FOR CLAMPING, THERE WAS NO EVIDENCE OF LEAKAGE AT THE SITE OF TUBING TO PUMP CONNECTION. THE SPECIFICATIONS OF THE DEVICE ARE NOT KNOWN TO THIS REPORTING FACILITY AS THE PROCEDURE WAS INITIALLY PERFORMED AT ANOTHER FACILITY. THE RESERVOIR AND CONNECTOR WERE RETURNED TO CO FOR EVALAUTION.
A 16F CATHETER PULLED APART. BALLOON AND TIP NOTED TO BE LEFT INSIDE BLADDER OF PT.
PT WAS SCHEDULED FOR LOW ANTERIOR COLON RESECTION. THE SURGEON REPORTED THAT THE STAPLER MISFIRED, LEAVING AN INCOMPLETE CLOSURE OF THE ANASTOMOTIC SITE. THE SURGEON OVERSEWED THE STAPLE LINE TO PREVENT LEAKAGE, RESULTING IN AN ADD'L 3 HOURS OF SURGERY TIME AND ANESTHESIA. VISUAL EXAM SHOWS THE PUSH BARS FIRED AND REMAINED IN THE "UP" POSITION. THERE DOES NOT APPEAR TO BE ANY STAPLES RETAINED IN THE DEVICE. AFTER CONSULTATION WITH THE CO REP, THE DEVICE WAS RETURNED TO THE MFR.
THIS 37-YEAR-OLD FEMALE UNDERWENT A BAM IN 1991. THE PT WAS INVOLVED IN A MVA ABOUT 2 YEARS AGO WHERE SHE SUSTAINED A TRAUMA TO THE RIGHT BREAST. RECENT EVALUATION SHOWS A RUPTURED RIGHT BREAST IMPLANT WITH FREE SILICONE THE RIGHT ARM. GROSS EXAM: THE RIGHT BREAST IMPLANT IS GROSSLY RUPTURED AND THE LEFT ONE IS INTACT.
LEFT HIP REVISION ARTHOPLASTY WAS DONE BECAUSE OF POLYETHYLENE WEAR. FOUND THAT POLY LINER DISENGAGED FROM METAL SHELL; ALSO TWO CONTAINMENT FINS WERE BROKEN FROM ACETABULAR SHELL. ORIGINAL SURGERY DATE 7/15/95. ADD'L MODEL  66246520, ADD'L LOT # 74951600.
ENT BLADE BROKE DURING PROCEDURE. STAFF UNABLE TO LOCATE METAL TIP. X-RAY ORDERED BY PHYSICIAN. OBJECT NOT VISIBLE ON X-RAY. OBJECT WAS FOUND BY STAFF PERSON AFTER PT WAS TRANSFERRED TO RECOVERY. OBJECT MEASURES APPROX 1/8" IN DIAMETER BY 3/8" IN LENGTH.
PT SCHEDULED FOR GENERATOR CHANGE. WHEN OLD LEADS WERE TESTED IN OR BY PHYSICIAN, AND MFR SALES REP PRESENT IN OR, IT WAS DETERMINED THAT THE OUTER INSULATION MUST HAVE BEEN FRACTURED. LEAD REPLACED.
DURING LAPAROSCOPIC CHOLECYSTECTOMY AN ATRAUMATIC GRASPER BROKE INSIDE THE ABDOMEN. AFTER THE DAMAGED INSTRUMENT WAS RETRIEVED AND THE PROCEDURE  COMPLETED X-RAYS INDICATED THAT A SMALL PIECE OF THE INSTRUMENT (APPROX 1MM IN SIZE) REMAINED IN THE PT.
SUMP DRAIN BROKE WHEN SURGEON ATTEMPTED TO REMOVE IT FROM PT. RETURN TO OR FOR SURGICAL REMOVAL OF PORTION OF TUBE REMAINING IN PT.
AFTER INSERTION OF 3.0 FR CATHETER INTO THE PT RPTR ATTEMPTED TO FLUSH THE CATHETER AND A DEFECT WAS NOTED AT JUNCTION OF THE CATHETER AND THE HUB. SALINE SOLUTION WAS NOTED SPRAYING FROM THIS JUNCTION. CATHETER WAS IMMEDIATELY REPLACED.
CATHETER BROKE AT JUNCTION OF THE CATHETER AND HUB. PT'S TPN WAS HELD FOR 16 HRS.
WHILE INSERTING AN INTRAOCULAR LENS IMPLANT IN PT'S RIGHT EYE THE HAPTIC BROKE. LENS AND HAPTIC WERE REMOVED AND REPLACED WITH ANOTHER.
AIR LEAK NOTED FROM TUBE UPON RETURN FROM X-RAY. AIR FELT BY HAND OVER PT'S MOUTH. AUDIBLE NOISE PRESENT. PT HAD TO BE REINTUBATED.
CUFF FOUND TO BE LEAKING. PT HAD TO BE REINTUBATED.
PORT USED FOR CHEMO THERAPY FOR 6 MONTHS BROKE OFF. PART REMOVED IN X-RAY AND OTHER PART WAS RETRIEVED IN THE OPERATING ROOM.
PT SCHEDULED FOR GENERATOR CHANGE. WHEN OLD LEADS WERE TESTED IN OR BY PHYSICIAN AND MFR REPRESENTATIVE PRESENT IN THE OR, IT WAS DETERMINED THAT THE OUTER INSULATION MUST HAVE FRACTURED. LEAD REPLACED.
RPTR'S 3 1/2-YR-OLD HAD A COLD. RPTR PUT THE VAPORIZER IN HIS ROOM TO RELIEVE HIS COUGH. THE BOX CARRIES THE SLOGAN "DESIGNED WITH YOUR CHILD IN MIND." UNFORTUNATELY THE HEAT WARNING WAS BURIED IN THE WARRANTY BOOK. THE CHILD GOT OUT OF BED AND PUT HIS HAND OVER THE OPENING. HE GOT A SECOND DEGREE BURN ON HIS HAND. RPTR THINKS THIS WOULD BE A BETTER PRODUCT IF IT WAS EXPLAINED IT WAS NOT SAFE FOR CHILDREN NOT CONFINED TO A CRIB AND PUT THE HEAT WARNING ON THE OPENING OF THE VAPORIZER WHERE IT COULD BE MORE CLEARLY SEEN.
CONSUMER FILLED VAPORIZER'S BASE WITH WATER AS INSTRUCTED, PLACED IT ON BEDROOM FLOOR, PLUGGED IT IN AND LEFT THE ROOM. ABOUT 10 MINUTES LATER, EXTREMELY HOT WATER BEGAN SPURTING OUT OF OPENING LOCATED ON TOP PORTION OF VAPORIZER. HOT WATER FELL ON AND BURNED PT'S RIGHT MIDDLE AND RING FINGERS; TREATED AT HOME. CONSUMER DISCONTINUED USE OF VAPORIZER BECAUSE SHE FEELS IT PRESENTS A BURN HAZARD TO BYSTANDERS. 1/4/96 PT WAS EXAMINED BY FAMILY PHYSICIAN WHO TOLD CONSUMER TO CONTINUE TO APPLY BURN OINTMENT ON THE BURN. 1/4/96 CONSUMER RETURNED VAPORIZER TO DEALER FOR A REFUND. 1/10/96 CONSUMER CALLED AND EXPLAINED INCIDENT TO MFR'S REP. (NAME UNKNOWN) WHO ADVISED CONSUMER TO SEND VAPORIZER TO MFR FOR INSPECTION; CONSUMER DIDN'T DO THIS BECAUSE SHE HAD ALREADY RETURNED VAPORIZER TO DEALER. OWNER'S MANUAL STATES: "EXTREME CAUTION IS NECESSARY WHEN VAPORIZER IS USED NEAR CHILDREN OR INVALIDS AND WHEN ANY VAPORIZER IS LEFT OPERATING UNATTENDED BECAUSE STEAM EMITTED CAN CAUSE BURNS. IMPROPER USE OF THIS APPLIANCE CAN CAUSE BURNS." UL LISTING UNKNOWN.
RPTR HAS PERFORMED EXTENSIVE RESEARCH ON VENTILATION DEVICES, WITH A SPECIFIC INTEREST IN TRANSPORT VENTILATOR AND HAS WORKED COOPERATIVELY WITH NUMEROUS VENTILATOR MANUFACTURERS. RECENTLY MADE AWAREOF DEVICE, RPTR OBTAINED A SAMPLE AND SUBJECTED IT TO THE STANDARD TESTING PROTOCOL. RPTR USED FOR OTHER TRANSPORT VENTILATORS. BECAUSE OF THE SERIOUS DEFICIENCIES IN THE DEVICE, RPTR DID NOT PERFORM THE FULL BATTERY OF TESTING OTHER TRANSPORT VENTILATORS ARE SUBJECTED TO. RPTR FOUND THE VENTILATOR TO BE OF POOR DESIGN WITH THE POTENTIAL TO HARM PTS, LARGELY DUE TO THE DELIVERY OF EXCESSIVE TIDAL VOLUMES TO PTS WITH DECREASED LUNG COMPLIANCE. IN UNINTUBATED PTS, THERE IS THE POTENTIAL FOR SEVERE GASTRIC INSUFFLATION. THIS IS DUE TO THE FACT THAT IT IS A PRESSURE LIMITED DEVICE SIMILAR TO MANY OLDER "RESUSCITATORS" SPECIFICALLY DESIGNATED BY THE AHA TO BE UNACCEPTABLE FOR USE DURING RESUSCITATION. THE VENTILATOR OFTEN FAILED TO CYCLE IN THE AUTOMATIC MODE. IT IS RPTR'S OPINION THAT THE DEVICE SUFFERS FROM SERIOUS DEFICIENCIES THAT MAKE IT UNACCEPTABLE FOR USE ON HUMANS, AND RECOMMENDS THAT MFR RECONSIDERS MARKETING THIS DEVICE.
ON 4/21/95, THE UNIT WAS BROUGHT FOR EVALUATION. IT WAS REPORTED THAT THE UNIT HAD SHOCKED A PT. CONCLUSION OF RPTR'S INVESTIGATION: PT WAS SHOCKED BY USE OF THE VAGINAL SENSOR WITH THE UNIT WITHOUT AN ADAPTER. ALTHOUGH MFR STATED THAT THIS WOULD CAUSE A "MILD" SHOCK TO THE PT, CIRCUIT DESIGN INDICATES THAT THE FULL CURRENT OF 12.1 MICROAMPS WAS APPLIED TO THE PT. NEITHER MFR NOR DISTRIBUTOR HAD INCLUDED ANY TYPE OF WARNING IN THEIR LITERATURE. RPTR IS RECOMMENDING THAT EACH MFR PRINT AND PUBLISH A WARNING TO ALL USERS OF THIS DEVICE THAT THE VAGINAL PROBE MUST NOT BE USED WITHOUT THE ADAPTER. RPTR BELIEVES THAT THE FOLLOWING ACTIONS SHOULD OCCUR: 1. THE MFR SHOULD SEND TO EACH CURRENT USER OF THE UNIT OR ANY OF THEIR OTHER PRODUCTS WITH SIMILAR DESIGN AND ADDENDUM TO THEIR OPERATORS AND SERVICE MANUAL INDICATING THAT THE VAGINAL PROBE MUST BE USED WITH AN ADAPTER. PACKAGING AND INSTRUCTIONS WITH THE UNIT ARE INADEQUATE. 2. THE DISTRIBUTOR SHOULD NOTIFY ALL CURRENT USERS OF VAGINAL PROBES PURCHASED FORM THEIR CO OF THE WARNING THAT USE OF THE VAGINAL PROBE WITHOUT THE ADAPTER WILL SHOCK PTS. DISTRIBUTOR SHOULD IMMEDIATELY PLACE SUCH A WARNING IN THE PACKAGING OF ALL VAGINAL PROBES THAT THEY SELL. 3. CONSIDERATION SHOULD BE GIVEN BY THE MFR AND ALL DISTRIBUTORS OF THE VAGINAL PROBE TO INCLUDE AN ADAPTER WITH THE SENSOR. OR AT MINIMUM, EACH CO SHOULD CONSIDER PLACING A POLICY INTO EFFECT THAT ASKS OR REQUIRES THE PURCHASER OF THE VAGINAL PROBE TO ACKNOWLEDGE THAT THEY ARE AWARE THAT THE VAGINAL PROBE MUST BE USED WITH AN ADAPTER. (*)
RPTR HAS HAD A CHRONIC BONE INFECTION FROM WIRE AND PLATE. SHE IS TRYING TO OBTAIN AS MUCH INFORMATION AS POSSIBLE ON DEVICES. SHE IS CONCERNED THAT DEVICES WERE NOT APPROVED AND WERE IMPLANTED ANYWAY. THE WIRE BEGAN COMING OUT OF HER ARM AND IT WAS RECOMMENDED IT BE REMOVED. RPTR ALSO SAW A SURGEON WHO RECOMMENDED PLATES BE REMOVED. (ALSO SEE 4001088)
RPTR HAS HAD A CHRONIC BONE INFECTION FROM WIRE AND PLATE. SHE IS TRYING TO OBTAIN AS MUCH INFORMATION AS POSSIBLE ON DEVICES. SHE IS CONCERNED THAT DEVICES WERE NOT APPROVED AND WERE IMPLANTED ANYWAY. THE WIRE BEGAN COMING OUT OF HER ARM AND IT WAS RECOMMENDED IT BE REMOVED. RPTR ALSO SAW A SURGEON WHO RECOMMENDED PLATES BE REMOVED. (ALSO SEE 4001087)
CONSUMER HAD USED THE LARGER MODEL OF THE DIABETES CARE KIT WITH NO PROBLEMS FOR 9 YEARS. IN MAY OF 1995 SHE SWITCHED TO THE SMALLER VERSION (PURSE SIZE) AND THE LAST TWO TEST STRIPS (WHICH CAME WITH THE KIT) READ INCORRECTLY. SHE SAID THEY READ OVER 400 POINTS OVER WHAT HER SUGAR ACTUALLY WAS. SHE SAID THAT SHE LATER HAD AN ADVERSE REACTION DUE TO TAKING TOO MUCH INSULIN (SHE HAD CONVULSIONS) AND WAS SEEN IN THE ER OF A LOCAL HOSP.
COMPLAINANT STATED SHE OPENED BOTTLE OF MULTIPURPOSE SOLUTION 1/30 FOR HER SON AND SAFETY SEAL WAS INTACT. HER SON POURED SOLUTION INTO LENS CASE AND HE SOAKED HIS CONTACTS OVERNIGHT. AT 7:00 AM WHEN HE PLACED THE LEFT LENS IN HIS EYE, HE FELL TO THE FLOOR SHOUTING HIS EYE WAS BURNING. COMPLAINANT TOOK LENS AND PLACED IT WITH MORE SOLUTION AND ENZYME TABLETS IN ANOTHER CASE TO SOAK/CLEAN WHEN COMPLAINANT NOTICED THE SOLUTION WAS PINK IN COLOR. COMPLAINANT THEN FOUND THE SOLUTION IN THE 12 OZ BOTTLE OF MULTIPURPOSE SOLUTION WAS PINK IN COLOR AND NOT CLEAR AS IT NORMALLY SHOULD BE. THIS BOTTLE WAS PURCHASED AT THE END OF DECEMBER 1995 AND NOT OPENED UNTIL 1/30/96.
27 GAUGE SHORT NEEDLES CAME TO RPTR'S OFFICE WITH THE ORIGINAL PACKAGE OPEN AND THE NEEDLE PACKAGE TAPED TOGETHER.
RPTR SAID THAT THE MFR VERBALLY PUSHES THEIR REPRESENTATIVES TO SELL THIS PRODUCT TO SURGEONS FOR USE ON THE SPINE. PRODUCT IS NOT APPROVED FOR THIS USE.
PHYSICIAN WAS USING A POWER DRILL TO PLACE SCREWS DURING AN OPEN REDUCTION INTERNAL FIXATION OF HIP FRACTURE. THE DRILL BIT TIP BROKE OFF IN THE BONE. SURGEON ATTEMPTED TO PASS ANOTHER DRILL BIT TO RETRIEVE BROKEN TIP AND THE SECOND BIT BROKE OFF ALSO. HE WAS ABLE TO RETRIEVE THE SECOND TIP, BUT NOT THE FIRST. IT WAS DECIDED TO LEAVE THE TIP IN PLACE RATHER THAN TO DO MORE EXTENSIVE SURGERY. THE PT IS NOW THREE DAYS POSTOP AND HAS HAD NO COMPLICATIONS FROM THIS INCIDENT.
THE FOUR-HOUR VOLUME LIMIT CAN BE EXCEEDED BY ROUTINE PCA BOLUS DOSING. TO GIVE AN EXAMPLE, WHICH RPTR HAS CONFIRMED BY TESTING: IF A PT IS TO RECEIVE AN 8 ML/HR INFUSION AND IS PROGRAMMED TO RECEIVE 12 ML BOLUSES, WITH A 20 MINUTE LOCK-OUT INTERVAL USING THE PCA FUNCTION, IT IS POSSIBLE FOR THAT PERSON TO EXCEED A 40 ML FOUR-HOUR VOLUME LIMIT. THIS IS CAUSED BY THE PUMP EXAMINING ITS FOUR-HOUR LIMIT, ONLY AT THE BEGINNING AND END OF A BOLUS DOSE, AND NOT DURING ITS INFUSION. THIS CAN POTENTIALLY COMPROMISE THE SAFETY OF THE PT, BY ALLOWING AN OVERDOSE OF DRUG. IN ADDITION, IT IS POSSIBLE TO PROGRAM LARGE BOLUS DOSES OF DRUG (UP TO 25ML). THESE TWO POTENTIALLY SERIOUS DEFICIENCIES WERE DISCOVERED WHEN A NURSE ACCIDENTALLY PROGRAMMED THE PUMP TO DELIVER BOLUSES OF 24ML, INSTEAD OF 2ML. FORTUNATELY THIS ERROR DID NOT RESULT IN A SERIOUS PATIENT ADVERSE OUTCOME, BUT POTENTIALLY COULD HAVE DONE SO. RPTR SUGGESTS THE FOLLOWING TWO SOFTWARE CORRECTIONS TO ELIMINATE THESE PROBLEMS: 1) THE PUMP'S PROGRAM EXAMINE WHETHER THE ADMINISTRATION OF A BOLUS EXCEEDS THE FOUR-HOUR LIMIT, AND THEN REFUSE THE BOLUS REQUEST IF IT DOES SO, 2) A LIMIT OF 10 ML BE SET FOR BOLUS AND LOADING DOSES. (*)
1/9/96: ICD INTERROGATED BATTERY STATUS AT BEGINNING OF LIFE. 2/15/96 PT SEEN IN PHYSICIAN'S OFFICE DUE TO DEVICE BEEPING. DEVICE INTERROGATED AND BATTERY FOUND TO BE AT MIDDLE OF LIFE AND UNABLE TO MAKE PROGRAM CHANGES. 2/20/96 ADMITTED TO HOSP, DEVICE CHECKED AND MORE BATTERY DEPLETION NOTED. 2/21/96 DEVICE REMOVED AND REPLACED WITH NEW DEVICE.
TUBING SEPARATED/BROKE APART BEFORE A CONNECTION, WHILE PT WAS RECEIVING TAXOL. SEEMED AS THOUGH PACLITAXEL "ATE THROUGH" TUBING. PT WAS IN BED, NOT MOVING AT TIME OF EVENT.
PT HAD CATHETER FOR IV MEDICATION ADMINISTRATION. AFTER APPROXIMATELY 2 WEEKS, PT FLUSHED CATHETER, OBSERVED WETNESS ON DRESSING AND REMOVED DRESSING TO DISCOVER APPROXIMATELY 4 INCHES OF CATHETER UNDER DRESSING (CATHETER LENGTH IS 6 INCHES). INSERTION SITE VISIBLE WITH NO CATHETER AT SITE. PT WAS SENT TO THE EMERGENCY ROOM BY ON-CALL NURSE. REQUIRED SURGICAL REMOVAL OF REMAINDER OF CATHETER IN RIGHT UPPER ARM.
RATE ALARM ON MONITOR WENT OFF. PT WAS FOUND TO BE IN WIDE COMPLEX THIRD DEGREE AV BLOCK AND NOT PACED. PT SPEAKING AND HAD ADEQUATE BP. CONNECTING CABLE BETWEEN PACING GENERATOR AND ELECTRODE FOUND BROKEN IN HALF. PT HAD BEEN AGITATED AND PERHAPS PULLED ON CABLE. CABLE REPLACED AND PT THEN HAD CAPTURE ON PACEMAKER. NO ADVERSE OUTCOME.
DRILL BIT BROKE DURING SURGERY. X-RAY TAKEN AND BIT RETRIEVED BY SURGEON. SURGERY WAS EXTENDED BY 15 MINUTES.
PT'S LEG GOT CAUGHT IN THE BED SIDERAIL. LEG WAS BROKEN AS IT WAS BEING REMOVED FROM SIDERAIL.
UPON EXPLANTATION SURGERY, RIGHT BREAST IMPLANT FOUND TO BE RUPTURED.
SURGEON WAS PERFORMING A LAPAROSCOPY WHEN INCIDENTAL CYSTOTOMY OCCURRED WITH TROCAR.
WHILE MFR'S ENGINEER WAS MAKING SOME ADJUSTMENTS ON TABLE (UNIT HAD BEEN GOING TO APPROXIMATELY 93 DEGREES TRENDELENBURG) TWO MAIN BEARINGS BROKE OFF DUE TO A FAILURE IN THE CASTING ON THE MAIN SECTOR. AT THAT TIME, THE TABLE MOVED DOWN A FEW INCHES AND, IF THE TWO SMALLER BEARINGS IN THE FRONT OF TABLE HAD FAILED, THE TABLE COULD HAVE FALLEN OFF. LUCKILY THIS INCIDENT DID NOT INVOLVE A PATIENT, BUT IT IS RPTR'S OPINION THIS CASTING SHOULD NOT BREAK. IF THERE HAD BEEN A PATIENT ON THE TABLE, THERE COULD HAVE BEEN GRAVE CONSEQUENCES. (*)
WIRE BASKET BECAME TWISTED AND BENT WHILE INSIDE THE PT.
MISFIRE OF STAPLER DURING LEFT UPPER LOBECTOMY.
PT UNDERGOING LAVH. SURGEON UNABLE TO CLOSE JAWS OF STAPLER BUT WAS ABLE TO PULL IT OUT OF ABDOMINAL WALL WITH NO APPARENT INJURY TO THE PT.
MACHINE MALFUNCTIONED DURING THE USE OF ULTRA-SOUND ELECTRICAL STIMULATION. PT FELT A SHOCK IN THE DISPERSIVE PAD. WHEN THE INTENSITY WAS LOWER, NO ELCTRICAL STIMULATION WAS FELT BY THE PT. WHEN INTENSITY INCREASED THE PT FELT A SHOCK AGAIN. AFTER RECHECKING MACHINE AND COMPONENTS AND RE-STARTING TREATMENT, PT SHOCKED. DISCONTINUED TREATMENT. EVENT REPORTED TO PT RELATIONS DEPARTMENT 7/21/95.
PT HAD A POSTERIORLY-DISLOCATED IOL. WHEN RPTR FIRST EXAMINED THE EYE BEFORE THE SURGERY, THERE WAS SOME MILD PIGMENTARY MOTTLING IN THE MACULA AND THE VISION WAS SIGNIFICANTLY REDUCED. RPTR REPOSITIONED THE INTRAOCULAR LENS, ALTHOUGH IT DIDN'T CENTER PERFECTLY. IT HAS REMAINED IN GOOD ENOUGH POSITION, HOWEVER, TO ALLOW PROPERLY-CORRECTED VISION. THE VISION IN THE EYE DID NOT COME BACK FULLY TO NORMAL. THERE WERE SOME PROBLEMS WITH THE CORNEA, BUT RPTR ALSO BECAME MORE AWARE OF PIGMENTARY CHANGES IN THE MACULA. HE HAS BEEN SUSPICIOUS THAT THESE MIGHT HAVE BEEN DUE TO PHOTIC INJURY FROM THE OPERATING MICROSCOPE, POSSIBLY AT THE ORIGINAL CATARACT SURGERY. PT NOTES THE BIGGEST ABNORMALITY IN HIS VISION JUST ABOVE FIXATION ON THE AMSLER GRID. THE PIGMENTARY CHANGES IN THE RETINA HAVE BEEN JUST ABOVE THE FOVEA, WHICH ORDINARILY WOULD PRODUCE A PROBLEM ON THE AMSLER GRID JUST BELOW FIXATION. (*)
SCREEN RECEIVED 6/94. NOTIFIED ON 5/1/95 OF PRODUCT RECALL BECAUSE SCREEN DID NOT CONTAIN LEAD. SCREEN REMOVED FROM SERVICE. EQUIPMENT INCIDENT REPORTED TO PT RELATIONS DEPARTMENT ON 7/25/95. PT RELATIONS DEPARTMENT FOLLOWED-UP WITH DISTRIBUTOR WHO HAS MADE A MED WATCH REPORT. PHYSICIAN AND EMPLOYEES USED SCREEN.
MACHINE MALFUNCTIONED DURING THE USE OF ULTRA-SOUND ELECTRICAL STIMULATION. PT FELT A SHOCK IN THE DISPERSIVE PAD. WHEN THE INTENSITY WAS LOWER, NO ELECTRICAL STIMULATION WAS FELT BY THE PT. WHEN INTENSITY INCREASED THE PT FELT A SHOCK AGAIN. AFTER RECHECKING MACHINE AND COMPONENTS AND RE-STARTING TREATMENT, PT SHOCKED. DISCONTINUED TREATMENT. EVENT REPORTED TO PT RELATIONS DEPARTMENT 7/21/95.
PORT IMPLANTED INTO LEFT SUBCLAVIAN AREA ON 7/14/95. LEAKING FROM NEEDLE SITE. PORT REPLACED ON 9/6/95.
THE INNER SLEEVE OF THIS INSTRUMENT HAD TWO PIECES OF TAPE WRAPPED AROUND IT FOR IDENTIFICATION. IT WAS FOUND DURING TESTING, THAT WHERE THE PIECES OF TAPE OVERLAPPED, THE RESULTING DOUBLE LAYER OBSTRUCTED OUTFLOW. WHEN TAPE WAS REMOVED, OUTFLOW INCREASED. PT ABSORBED FLUID, DEVELOPED PULMONARY EDEMA.
PT TO AMBULATORY SURGERY CENTER FOR REMOVAL OF BILATERAL RUPTURED SILICONE GEL MAMMARY PROSTHESES. RIGHT SIDE - MODERATE CAPSULE CONTRACTURE, NO SILICONE IN FREE TISSUES; ALL SILICONE REMOVED. PATHOLOGY: SURROUNDING TISSUE WITH CHRONIC INFLAMMATION AND FOAMY MACROPHAGES. LEFT SIDE - RUPTURED WITH LEAKAGE OF SILICONE; FOUND SILICONE GRANULOMAS. MAJORITY OF CAPSULE REMOVED. PATHOLOGY: SAME AS RIGHT SIDE WITH ADDITION OF MULTINUCLEATED FOREIGN BODY TYPE GIANT CELLS.
CARDIOLOGIST WAS PERFORMING A PTCA/STENT PROCEDURE. THE GUIDE WIRE WAS ACROSS THE LESION AND THE BALLOON EXPANDABLE STENT IN PLACE. THE GUIDER BACKED OUT OF THE RCA. ATTEMPT TO RE-ENGAGE GUIDER INTO THE ARTERY FAILED, SO THE CARDIOLOGIST REMOVED THE WIRE, STENT AND GUIDER FROM THE PT. THE STENT COULD NOT BE LOCATED, THOUGHT TO BE DEPLOYED IN THE PT. THE STENT COULD NOT BE LOCATED UNDER FLUOROSCOPY. PT WAS ANTI-COAGULATED.
DURING DIAGNOSTIC LAPAROSCOPY AND LEFT SALPINGOOPHORECTOMY, HANDLE OF INSTRUMENT WOULD NOT LOOSEN FROM THE STAPLE LINE AND DR. COULDN'T GET STAPLER TO FIRE.
BALLOONS UNFURLED WHEN FIRST TESTED OUTSIDE OF THE PT. AFTER BALLOONS WERE INSERTED INTO FEMORAL ARTERY AND POSITIONED, THEY WOULD NOT UNFURL. A THIRD BALLOON WAS USED AND WAS FUNCTIONAL. THIS CAUSED A DELAY IN TREATMENT FOR THE PT WHO WAS IN SURGERY AT THE TIME.
POST INSERTION OF CENTRAL LINE CATHETER PT DEVELOPED RESPIRATORY DISTRESS. PT SUBSEQUENTLY WENT INTO RESPIRATORY ARREST. CODE ALERT CALLED. AFTER TWO SUCCESSFUL ATTEMPTS DEFIBRILLATOR WAS NOT OPERATIVE ON 3RD ATTEMPT. TWO DOPPLER INSTRUMENTS UTILIZED DURING CODE FAILED TO REGISTER A PULSE. A THIRD UNIT WAS OBTAINED AND WORKED FINE. THE PT'S BED COULD NOT BE ADJUSTED INTO THE TRENDELENBURG POSITION. IT WAS ALSO SUBSEQUENTLY REPAIRED. THE PT WAS PRONOUNCED DEAD AT 5:26 PM. CLINICAL ENGINEERING EVALUATED THE TWO DOPPLERS AND CONFIRMED THEIR NON-OPERATION. A CHECK OF THE DEFIBRILLATOR FOUND NO MECHANICAL PROBLEMS.
PT HAD SURGERY FOR BILATERAL BREAST IMPLANT REMOVAL. SURGICAL FINDINGS: LEFT SIDE "SIGNIFICANT AMOUNT FREE SILICONE ON SURFACE OF IMPLANT." NO GROSS DISRUPTIONS OF IMPLANT. CAPSULE ALSO REMOVED. RIGHT SIDE - MASSIVELY RUPTURED IMPLANT WITH LOSS OF CONTINUITY OF THE SHELL. PT WAS DISCHARGED SAME DAY AS SURGERY. IMPLANTS ARE NOW IN PT'S POSSESSION.
WHILE INSERTING THE GUIDE WIRE TO PLACE THE CATHETER THROUGH THE LEFT ULNAR ARTERY, THE PHYSICIAN MET RESISTANCE AND ATTEMPTED TO REMOVE THE GUIDE WIRE. SHE WAS UNABLE TO DISLODGE THE CATHETER AND GUIDE WIRE. AN X-RAY WAS TAKEN AND REVEALED THE WIRE KNOTTED WITHIN THE ARTERY. SURGERY TO DO AN ARTERIAL CUTDOWN AND REMOVE THE KNOTTED WIRE WAS REQUIRED. ALL #3 CATHETERS HAVE BEEN PULLED FROM STOCK AND RETURNED TO THE MFR, AS THIS IS THE SECOND INCIDENT LIKE THIS. ON 6/14/95 CLINICAL ENGINEERING EVALUATED THE GUIDE WIRES AND TWO ADD'L CENTRAL VENOUS CATHETER KITS. NO OBJECTIVE CONCLUSIONS COULD BE REACHED FROM THE EVALUATION.
CHRONIC CYSTOID MACULAR EDEMA POSSIBLY RELATED TO ANTERIOR CHAMBER INTRAOCULAR LENS. LENS EXPLANTED 7/11/95.
MAMMARY IMPLANT HAD PIN-POINT LEAK AND WAS EXPLANTED.
PT HAD KNOWN HISTORY OF CAD, POST-ANGIOPLASTY FROM 3/95. BROUGHT TO HOSP AFTER COLLAPSING WHILE JOGGING, CPR, CARDIAC ARREST. PT HAD BEEN ON IABP SINCE ADMISSION ON 9/5/95; ON SETTINGS OF 1:2, CARDIAC OUTPUT 7.13/INDEX 3.38 JUST BEFORE TRANSPORT TO CT SCAN. NO SIGNIFICANT CHANGES IN PT STATUS JUST AFTER INCIDENT. BALLOON PUMP STOPPED WORKING DURING PT TRANSPORT BACK FROM SCAN. LOW BATTERY ALARM SOUNDED FOR APPROX 5 MIN DURING TRANSPORT TO AND FROM CT SCAN. PT WAS JUST OUTSIDE OF THE CICU WHEN PUMP STOPPED. BIOMED WILL NOW CHANGE OUT ALL BATTERIES YEARLY. THIS BATTERY WAS APPROX 21 MONTHS OLD. HOSP HAS HAD OTHERS LAST UP TO 5 YEARS. HOSP STAFF WAS AWARE OF ONE YEAR WARRANTY OF PUMP, HAD IN THE PAST ROUTINELY CHANGED LEAD-ACID BATTERIES EVERY TWO YEARS. THE UNIT IN QUESTION IS UNDER A SERVICE CONTRACT AND HAS BEEN SUBJECTED TO A PREVENTIVE MAINTENANCE WITHIN THE SIX-MONTH PERIOD FROM THE DATE OF THE EVENT. THE UNUSUAL FACT REGARDING THIS PREVENTIVE MAINTENANCE WAS THAT A HOSP REP DECLINED THE BATTERY RUN TIME TEST WHICH IS RECOMMENDED BY CO. IF THIS BATTERY RUN TIME TEST WAS PERFORMED THERE IS A STRONG POSSIBILITY THAT THE EVENT WOULD HAVE BEEN AVOIDED.
FAILED LEFT BREAST IMPLANT. PT HAD NOTED DECREASING VOLUME OF LEFT BREAST. WHEN EXPLANTED, THE IMPLANT WAS FOUND TO HAVE TWO VERY TINY PUNCTURE WOUNDS.
PT HAD DIFFUSE CORNEAL EDEMA AND CORNEAL DECOMPENSATION FELT TO BE RELATED AT LEAST IN PART TO THE INTRAOCULAR LENS. THE IOL WAS EXPLANTED, A CORNEAL GRAFT WAS DONE, AND A NEW IOL WAS IMPLANTED. THE MAJOR INDICATION FOR THIS SURGERY WAS TO DECREASE INFLAMMATION AND IMPROVE VISION.
PT HAD LUMBAR LAMINECTOMY ON 10/9/95. WOUND DRAIN WAS INSERTED. FIRST TUBE OF DRAIN REMOVED WITHOUT DIFFICULTY. ATTEMPTED REMOVAL OF SECOND DRAIN TUBE MET WITH RESISTANCE. CONSTANT SLOW PRESSURE APPLIED BY NURSE AND TUBING SNAPPED. PT WENT TO SURGERY ON 10/12/95 FOR REMOVAL OF THE RETAINED FRAGMENT, MEASURING 10.4 CM IN LENGTH. OPERATIVE FINDINGS: NO SUTURE ABOUT THE RETAINED FRAGMENT, NOR EVIDENCE OF PERFORATION; REMOVED BY SURGEON WITHOUT DIFFICULTY.
STENT WAS INSERTED IN LEFT URETER IN PREPARATION FOR LITHOTRIPSY. PT HAD TO BE RESCHEDULED FOR THE PROCEDURE, SO SURGEON ELECTED TO REMOVE STENT BY PULLING ON THE TETHER. RESISTANCE WAS MET. UNDER FLUOROSCOPY, END OF STENT NOTED TO BE IN KIDNEY PELVIS, FOLDED OVER ON ITSELF. CONSIDERABLE MANIPULATION WAS DONE AND ANOTHER SURGICAL SET-UP WAS ARRANGED TO RE-INSERT THE STENT, ELIMINATE THE KINK. STENT WAS REMOVED AND SENT TO MFR.
THE ANTERIOR CHAMBER INTRAOCULAR LENS WAS IMPLANTED IN 1986 IN THE RIGHT EYE. THE PT HAS NOW DEVELOPED BAND KERATOPATHY AND CORNEAL DECOMPENSATION. TO IMPROVE VISION AND RELIEVE PAIN AND DISCOMFORT, SURGERY TO EXPLANT THE IOL, DO A CORNEAL TRANSPLANT, AND IMPLANT A POSTERIOR CHAMBER INTRAOCULAR LENS WAS DONE.
PT WAS SCHEDULED FOR RIGHT HEPATIC LOBECTOMY. THIS COAGULATOR, NEEDED TO ACHIEVE HEMOSTASIS DURING SURGERY, WOULD NOT FUNCTION AT ALL. PT HAD A BLOOD LOSS WHICH EXCEEDED EXPECTATIONS AND REQUIRED TRANSFUSION OF DONOR BLOOD AS WELL AS AUTOLOGOUS. UPON INVESTIGATION, IT WAS LEARNED THAT THE HOSP-OWNED COAGULATOR HAD BEEN SENT IN FOR REPAIRS AND THE UNIT USED FOR THIS SURGERY WAS A LOANER, AND A DIFFERENT MODEL. BEFORE THE SURGERY, UPON RECEIPT OF LOANER, IT WAS CONNECTED TO THE HOSP-OWNED STAND BY BIOMED TECH. WHEN CONNECTING UNIT TO THE STAND, BIOMED NOTED THAT CONNECTORS APPEARED TO BE COMPATIBLE. POST-INCIDENT, CONNECTOR EXAMINED AND IT WAS NOTED THAT THERE IS ACTUALLY A DIFFERENCE. THE LOANER UNIT HAS FEWER PINS IN CONNECTOR AND NO FOOT PEDAL CONNECTION. THE ONLY HANDPIECE AVAILABLE HAS TO BE ACTIVATED BY A FOOT PEDAL. HOSP DIDN'T REALIZE THE LOANER WAS A DIFFERENT MODEL AND THERE IS NO LABELING STATING THAT AN OLDER STAND WOULD NOT BE COMPATIBLE. LOANER SENT BACK TO CO.
DURING A PROCEDURE THE RUBBER BOOT FELL OFF THE SPRING ON A TROCAR. THIS WAS NOTED AT THE END OF THE CASE. DUE TO DANGER TO THE PT FROM A RETAINED FOREIGN BODY THE OR STAFF SEARCHED THE STERILE FIELD AND DRAPES, TRASH AND FLOOR UNTIL RUBBER BOOT WAS LOCATED. THE LATEX RUBBER BOOT WAS SENT TO CLINICAL ENGINEERING FOR EVALUATION. THE EVALUATION FOUND THAT THE LATEX RUBBER BOOT FITS THE SPRING LOOSELY. THIS IS A MFG DEFECT. OR STAFF REPORT THAT THEY HAVE HAD THIS PROBLEM IN THE PAST AND THAT THE DESIGN OF THIS PRODUCT IS THE CAUSE OF CHRONIC PROBLEMS WITH DEVICE.
BABY'S BLOOD SUGAR BECAME UNSTABLE REQUIRING THREE SEPARATE IV BOLUSES OF 10% DEXTROSE. IV CASSETTE THEN NOTED TO BE LEAKING TOTAL PARENTERAL NUTRITION IV FLUIDS. BABY IS CRITICALLY ILL WITH BLOOD PRESSURE FLUCTUATIONS ALONG WITH THE UNSTABLE BLOOD SUGAR. IT IS THE PHYSICIAN'S OPINION THAT THE BLOOD SUGAR PROBLEMS AND RESULTANT DEXTROSE BOLUSES WERE RELATED TO LEAK IN IV TUBING.
FAILURE OF THIS PENILE PROSTHESIS WAS DUE TO RUPTURE OF TUBING FROM TEH RESIPUMP TO THE LEFT CORPORAL CYLINDER. THE PROSTHESIS WAS EXPLANTED AND REPLACED WITH ANOTHER PROSTHESIS.
VENTILATOR ALARM SOUNDING. "RESET" BUTTON NOT EFFECTIVE. CONTROL PANEL LIGHTS WERE OUT AND FAILED TO RESPOND TO "LAMP TEST." THEN PANEL LIGHTS BACK ON ON LEFT SIDE. VENT FAILED TO CYCLE. PT PLACED ON NEW VENTILATOR, HAD TO BE BAGGED WITH 100% 02 DURING THIS. BIOMED RAN UNIT THROUGH SEVERAL EST'S AND NO PROBLEMS. VENT RAN OVERNIGHT ON TEST LUNG WITH NO PROBLEMS.
VENTILATOR FAILED TO PRESSURIZE CIRCUIT. TURNED VENTILATOR OFF AND BACK ON AND IT FAILED EST. PT HAD TO BE BAGGED WITH 100% 02 WHILE VENTILATORS SWITCHED OUT. VENT SENT TO BIOMED. FINDINGS: LIQUID WAS SPILLED ONTO SOLENOID, CAUSING IT TO FAIL.
AFTER TWIN-JET IN-LINE SYSTEM SET UP INTO CIRCUIT, UNIT WENT "IN-OPERATIVE" DUE TO A FLOW CONTROL PROBLEM. SWITCHED OUT WITH ANOTHER VENTILATOR, THIS ONE RECALIBRATED AND OPERATION CHECKED OK. PT REQUIRED AMBU-BAGGING WHILE VENTILATORS SWITCHED.
VENTILATOR WENT "INOP" WHILE PT ON IT, RESET AND WORKED FINE. THIS OCCURRED WITHOUT WARNING AND NO ALARMS OTHER THAN "INOP" SOUNDED. VENT WAS SWITCHED OUT AND CHECKED BY BIO-MED WITH EXISTING CIRCUIT IN PLACE. RAN SELF-TEST TWO TIMES AND COULD NOT RECREATE SITUATION. RETURNED TO SERVICE. PT WAS VENTILATOR-DEPENDENT.
THE PT DEVELOPED PSEUDOPHAKIC BULLOUS KERATOPATHY AND FAILED GRAFT IN THE RIGHT EYE. THE ANTERIOR CHAAMBER INTRAOCULAR LENS WAS FOUND TO BE ANTERIORILY DISPLACED AND WAS EXPLANTED. A NEW INTRAOCULAR LENS WAS IMPLANTED AND A CORNEAL GRAFT DONE.
VENTILATOR SETTINGS 50% 02, ASSIST CONTROL RATE 18, PEEP +6. VENTILATOR ALARMED, PEEP FOUND AT 20 CM. PEEP VALVE TURNED OFF CAUSING 5-18 CM PEEP TO FLUCTUATE ON MANOMETER AND DIGITAL READOUT. BIO-MED RAN UNIT ON A TEST LUNG, ADJUSTED PEEP VALUE, UNABLE TO DUPLICATE PROBLEM. PT WAS VENTILATOR DEPENDENT, REQUIRING AMBU BAGGING WHILE VENT WAS CHANGED OUT. PT EXPERIENCED NO PROBLEM.
AT 1800, A 1 LITER BAG OF SALINE WAS HOOKED ONTO TUBING. AT 2200, BAG WAS FOUND TO BE EMPTY. TUBING WAS NOT CLAMPED, NO WATER LEAK NOTED. NURSE ASPIRATED INJECTATE SYRINGE AND FOUND THE ONE-WAY VALVE INEFFECTIVE. PHYSICIAN WAS NOTIFIED AND LASIX WAS ORDERED. THE TUBING SYSTEM WAS DISCARDED INADVERTENTLY.
ON 8/3/95 AN RN ON DUTY WAS SHOCKED AND SUFFERED SECOND DEGREE BURNS ON HER RIGHT HAND. THE RN WAS HOLDING THE PADDLES IN PALMS OF HER HANDS TO CHECK FOR WAVE FORMATION ("QUICK LOOK FUNCTION"). THE MACHINE HAD BEEN SET AT TEST 100 JOULES, AND A SECOND RN HIT THE CHARGE BUTTON AND THE MACHINE FIRED. THE DIRECT CAUSE OF THIS ADVERSE EVENT IS USER ERROR. THE "QUICK LOOK" FUNCTION SHOULD NOT BE CHECKED BY PLACING THE HANDS UNDER PADDLES. THE DEFIBRILLATOR WAS REMOVED FROM SERVICE AND EVALUATED IN THE CLINICAL   ENGINEERING DEPARTMENT. DEVICE MEETS MFR'S SPECIFICATIONS FOR FUNCTION AND SAFETY.
CHILD WAS UNDER GENERAL ANESTHESIA FOR BALLOON ANGIOPLASTY PROCEDURE FOR COARCTATION OF AORTA. BALLOON DILATION WAS COMPLETED AND THE BALLOON CATHETER HAD BEEN REMOVED OVER THE WIRE LEAVING ONLY THE WIRE IN ARTERY. THIS SHEATH WAS TAKEN FROM CATH LAB STORAGE CABINET AND BROUGHT TO THE CARDIOLOGIST WHO INSERTED THE SHEATH WITH DILATOR INTO ARTERY OVER THE EXISTING WIRE. DILATOR WAS REMOVED AND CARIOLOGIST IMMEDIATELY NOTICED THE HUB OF THE SHEATH ON THE DILATOR. CARDIOLOGIST THEN ATTEMPTED TO REMOVE THE REMAINING PORTIONS OF THE SHEATH WHEN THEY BROKE CLOSE TO THE HUB. OTHER SMALL PIECES WERE REMOVED USING BALLOONS. CARDIOVASCULAR SURGEON BECAME INVOLVED, FEMORAL ARTERY CUTDOWN WAS PERFORMED AND OTHER FRAGMENTS REMOVED WITH EMBOLECTOMY CATHETERS. AREA WAS CLOSELY INSPECTED UNDER FLUORO BY BOTH DRS. LATER IN THE DAY, CHILD RETURNED TO SURGERY FOR AN EMBOLECTOMY.
THE PT HAD REMOTE INTERCAPSULAR CATARACT EXTRACTION WITH THE INSERTION OF AN ANTERIOR CHAMBER IOL IN ABOUT 1982 IN THE LEFT EYE. HE NOW HAD DIFFUSE CORNEAL EDEMA AND PSEUDOPHAKIC BULLOUS KERATOPATHY OF THE LEFT EYE POSSIBLY DUE TO THE IOL. FOR PAIN RELIEF FROM THE BULLOUS KERATOPATHY AND TO IMPROVE HIS VISION, SURGERY WAS PERFORMED TO EXPLANT THE LEISKY AC IOL, DO A CORNEAL TRANSPLANT, AND TO IMPLANT A NEW POSTERIOR CHAMBER LENS.
OUTPATIENT ONCOLOGY CLINIC NURSE NOTED THAT ACCESS PORT HAD NO BLOOD RETURN AND FLUSHED SLUGGISHLY, WITH TENDERNESS AT AREA. NOTED PUFFINESS UNDER CLAVICLE. CHEST X-RAY SHOWED SEPARATION OF CATHETER. CATHETER SEGMENT REMOVED FROM LEFT PULMONARY ARTERY BY A SNARE. UNDER FLUOROSCOPY BY RADIOLOGIST, REMAINDER OF ACCESS PORT REMOVED BY PEDIATRIC SURGEON ON 8/14/95.
PT IN THE MICU WAS BEING MONITORED WITH A PULSE OXIMETER WHICH REGISTERED AN SAO2 OF 100%. AFTER CHANGING THE PROBE THE PULSE OXIMETER REGISTERED 78%. AN ARTERIAL BLOOD GAS WAS THEN DRAWN THEN SHOWED PH 7.40, PACO2 29, AND 73% SAT. THE PULSE OXIMETER PROBE WAS SENT TO CLINICAL ENGINEERING. VENTILATOR SETTINGS WERE INCREASED TO BRING SAO2 INTO NORMAL RANGE. THE CLINICAL ENGINEERING DEPARTMENT FOUND THE PROBE TO MEET SPECIFICATIONS FOR FUNCTION AND SAFETY. THEY COULD NOT FIND ANY REASON FOR THE FALSE READING OF 100% WHEN THE PT'S SATURATION WAS 55%.
PACEMAKER WAS SEEN TO BE FIRING ON T-WAVE. PT WENT INTO V-TACH, AND REQUIRED CARDIOVERSION.
A 20 FOLEY CATHETER IN USE ON PT DEVELOPED A HOLE WHICH DEFLATED BALLOON, CAUSING IT TO FALL OUT. PT WAS TAKEN TO SURGERY TO REINSERT A NEW FOLEY CATHETER.
CONNECTOR FOR LIGHT SOURCE ON RETRACTOR TOUCHED SKIN ON UPPER LEFT ANTERIOR CHEST WALL AND BURNED AREA. DR NOTIFIED, AREA DRESSED AND PT AND FAMILY INFORMED. AREA 1/2" X 1 1/2" APPROX. WHEN RETRACTOR WAS PURCHASED, SALES REP WAS ASKED ABOUT AN ADAPTER TO FIT RETRACTOR TO HOSP'S LIGHT CORD. ADAPTER USED OVER 30 TIMES WITHOUT PROBLEMS. SALES REP NOTIFIED OF THIS EVENT ON 11/15/95.
PHYSICIAN WAS UTILIZING A PHACOEMULSIFIER ULTRASONIC HANDPIECE, WHEN FINE "GOLD" METAL PARTICLES WERE NOTICED IN THE PT'S EYE. THE EYE WAS IRRIGATED AND ASPIRATED UNTIL THERE WERE NO FURTHER FRAGMENTS VISIBLE. ON 11/15/95 THE MFR'S SERVICE REPRESENTATIVE PERFORMED A WARRANTY MAINTENANCE PROCEDURE ON THE PHACOEMULSIFIER.
PT UNDER ANESTHESIA UNDERGOING SKIN GRAFT. DURING MIDDLE OF ANESTHESIA PT SWITCHED FROM VENTILATOR TO BAG. CRNA UNABLE TO VENTILATE AND RETURNED PT TO VENTILATOR WITH PROBLEM. ATTEMPTED PROCEDURE SEVERAL TIMES WITH SAME RESULT. AT ONE POINT WAS ABLE TO GET BAG APPARATUS TO WORK. DECISION MADE TO CONTINUE WITH BAG BECAUSE SURGERY WAS OVER. AMBU AND O2 TANK CALLED FOR BACK UP. PT UNAFFECTED. NO CHANGE NOTED ON GAS ANALYZER. BIOMED AND CO REPAIR REPRESENTATIVE CONTACTED. BROKEN SHEAR/PIN FOUND IN THE AUTO/BAG SELECTOR MECHANISM.
BILATERAL BREAST IMPLANTS IMPLANTED 9/6/94. RIGHT BREAST RECONSTRUCTION REVISED 1/17/95. LEFT IMPLANT REVISED AND RIGHT CAPSULOTOMY PERFORMED 7/26/95. RIGHT CAPSULOTOMY PERFORMED ON 8/28/95. ON 9/27/95 RIGHT BREAST IMPLANT EXPLANTED.
THE FIRST UNIT OF O NEGATIVE BLOOD AND ONE LITER OF NORMAL SALINE UNDER PRESSURE VIA CENTRAL LINE HAD INFUSED WITH NO PROBLEM. TRANSFUSER THEN FLASHED MESSAGE - "CODE 21-SERVICE NEEDED, TEMP DECREASED 28 DEGREE C". BLOOD FLUID POURING OUT OF CASSETTE AND DRIPPING OUT OF INSIDE OF MACHINE. PT EXPIRED DURING EMERGENCY THORACTOMY WITH REPAIR OF DESCENDING THORACIC AORTIC RUPTURE. MD DOES NOT BELIEVE PROBLEM WITH BLOOD WARMER AFFECTED OUTCOME.
THE DRAINAGE TUBE WAS TO BE REMOVED. THE NURSE ATTEMPTED REMOVAL AND WAS UNABLE TO DO SO. THE PHYSICIAN ATTEMPTED REMOVAL AND WAS UNSUCCESSFUL. PHYSICIAN TRIED AGAIN, AT WHICH TIME, THE DRAIN BROKE OFF. A 15 CM OF THE DRAIN REMAINED IN THE PT'S INCISION AND PT WAS RETURNED TO SURGERY FOR REMOVAL.
THE PT UNDERWENT BILATERAL FIRST STAGE BREAST RECONSTRUCTION WITH TISSUE EXPANDERS ON 9/12/95. THE PT WAS TAKEN BACK TO SURGERY ON 10/14/95 FOR REMOVAL OF RIGHT INFECTED BREAST EXPANDER.
FILIFORM SNAPPED OFF LEAVING A PORTION OF THE PRODUCT IN THE PT DURING PROCEDURE (DILATION). PRODUCT HAD BEEN PREVIOUSLY RESTERILIZED.
AN INVASIVE PROCEDURE WAS PERFORMED TO REPOSITION LEAD AFTER IT BECAME DISLODGED. THE SECOND PROCEDURE WAS PERFORMED THE SAME DAY AS THE INITIAL IMPLANT. IMPLANT DATE:1/26/96 REMAINS ACTIVE.
LEAD SYSTEM EXHIBITED "INAPPROPIATE SHOCKS WITH THE EPICARDIAL LEADS WITH SUSPECTED INSULATION OF WIRE FAILURE AND ABNORMAL BEEP TONES." THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALSO EXPLANTED. A SERIOUS INJURY REPORT HAS BEEN FILED ON THE ICD. REFERENCE FIRM CONTROL NUMBER 51996. CO WILL ASSUME THE LEADS ARE CAPPED AND REMAIN IMPLANTED. LEAD IMPLANT DATE-6/28/91, OUT OF SERVICE DATE-1/24/96, TOTAL IMPLANT TIME-54 MO.
PT TRANSFERRED TO FACILITY. INITIAL HOSP NOTED LONG INTERVALS OF P WAVES WITHOUT QRS. PT WAS ASYMPTOMATIC. PT NOTED TO HAVE ATRIAL FIBRILLATION WITH EPISODES OF FAILURE TO CAPTURE. LEAD WAS CAPPED AND REMAINS IN THE PT.
THE ADAPTER WAS FRACTURED CAUSING INAPPROPIATE NOISE AND DEVICE ABORTS. THE ADAPTER WAS EXPLANTED. IT WAS REPORTED THAT THE ICD WAS FUNCTIONING APPROPRIATELY.
PACEMAKER REPLACED FOR END OF LIFE. LEAD CAPPED BECAUSE OF SENSING DIFFICULTIES. POOR SENSING NOTED AT 2.5 MVOLTS WHICH CORRECTED AT 1.25 MVOLTS. LEAD IMPEDANCE 109 OHMS. PACEMAKER WAS ORIGINALLY PLACED FOR SYMPTOMATIC BRADYCARDIA IN 1989.
GAMMA CAMERA MALFUNCTIONED. IT DESCENDED AND PRESSED AGAINST THE PT'S ABDOMEN. NO PHYSICIAL INJURY NOTED OR DESCRIBED BY PT OR PHYSICIAN. PT DESCRIBED HAVING BEEN FRIGHTENED BY THE EPISODE. SHE WAS SEEN ON AN OUTPATIENT BASIS AND WAS CONSIDERED STABLE AND WAS DISCHARGED THE SAME DAY. REPORT FILED BECAUSE OF POTENTIAL FOR INJURY.
DURING VENTILATOR CHECK, RESPIRATORY TECHNICIAN NOTED LEAKING OF AIR AROUND EXHALATION PORT, UPON CLOSER OBSERVATION HEATER WIRES HAD PARTIALLY MELTED THE PLASTIC TUBING. BREATHING CIRCUIT CHANGED IMMEDIATELY. NO INJURY TO THE PT. REPORT BECAUSE OF POTENTIAL FOR INJURY.
BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM USED IN CARDIAC CATH PROCEDURE. AS STENT ABOUT TO BE DEPLOYED, THE STENT SHEATH RETRACTED, REQUIRING REMOVAL OF THE STENT. IT WAS TO BE DEPLOYED IN THE SAPHENOUS VEIN TO THE CORONARY. PT DID HAVE ANOTHER STENT PLACED IN THE INTENDED POSITION. DISLODGED STENT REMAINS IN THE FEMORAL AREA. VASCULAR CONSULT WAS PERFORMED AND IT WAS RECOMMENDED THAT THE STENT NOT BE REMOVED. PT HAS REMAINED STABLE WITH NO FURTHER COMPLICATIONS AND WAS DISCHARGED HOME ON 10/24/95.
PT UNDERWENT INSERTION OF A PERCUTANEOUS CENTRAL VENOUS SILASTIC CATHETER ON 10/25/95. OBSTRUCTION NOTED 5 DAYS AFTER INSERTION. ABBOKINASE WAS USED WITHOUT BEING ABLE TO CLEAR THE CATHETER. THIS CATHETER WAS REMOVED AND ANOTHER INSERTED AND BECAME OBSTRUCTED WITHIN 48 HOURS ON 11/1/95. UROKINASE WAS ADMINISTERED IN AN ATTEMPT TO CLEAR THE OBSTRUCTION WITHOUT SUCCESS. INITIAL CATHETER NOTED TO HAVE A SMALL CRIMP ON THE END OF THE CATHETER. NOTHING UNUSUAL NOTED ON VISUAL EXAMINATION OF THE SECOND CATHETER. BOTH CATHETERS FORWARDED TO THE MFR FOR EXAMINATION. THE PT HAS SINCE RECEIVED AN IV CUTDOWN. THE PT WAS RECEIVING HYPERALIMENTATION AND LIPIDS THROUGH THIS LINE.
PT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY. SHEATH COULD NOT BE WITHDRAWN. PT HAD A 95% STENOTIC LESION IN THE PROXIMAL LAD. STENT WAS USED. PT WAS DISCHARGED FROM THE HOSP ON 11/10/95 WITH NO REPORTED ILL EFFECT RELATED TO THE INCIDENT.
DURING PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY, DEVICE FAILED TO OPERATE. SHEATH COULD NOT RETRACT, INFLATED IN PROXIMAL RCA. BALLOON DID NOT DEFLATE, INFLATED BALLOON PULLED BACK ACROSS LESION IN PROXIMAL LAD. UPON REMOVAL THE BALLOON WAS NOTED TO BE RUPTURED. PT'S BLOOD PRESSURE AND HEART RATE DROPPED TO SYSTOLIC OF 60 AND RETURNED TO NORMAL OF 180'S AFTER REMOVAL OF THE BALLOON. PT IS NOT REPORTED TO HAVE SUFFERED ANY FURTHER EFFECT FROM THIS INCIDENT.
DENTAL IMPLANT FAILED TO OSSEOINTEGRTE.                                       DENTAL IMPLANT FAILED TO OSSEOINTEGRATE.
DR STATED "THIS THING DID NOT STOP ONCE THROUGH THE SKULL."
NEWBORN UNDERGOING CARDIOVASCULAR SURGERY TO REPAIR TETRALOGY OF FALLOT AND PULMONARY ATRESIA. BYPASS STARTED AT 0859 HRS. AT 0929 HRS AIR WAS DETECTED IN ARTERIAL CANNULA FROM THE TIP OF THE CANNULA RETROGRADE 36" IN THE ARTERIAL LINE. LINE WAS CLAMPED IMMEDIATELY. A TRANSDUCER WAS CHANGED AT THE TIME. A 14 FRENCH VENOUS CANNULA WAS PLACED IN THE INFERIOR VENA CAVA AND RETROGRADE CEREBRAL PERFUSION WAS ESTABLISHED AT 0929 HRS. THE PRESSURE OF THE CEREBRAL PERFUSION WAS MAINTAINED AT 30MM/HG. CEREBRAL PERFUSION WAS MAINTAINED UNTIL 0947 HOURS FOR TOTAL OF 18 MINUTES AT 20 DEGREES. THE TRANSDUCER HAS BEEN SENT FOR EVALUATION. THE REMAINDER OF THE OPERATION WAS UNEVENTFUL. PT DISCHARGED IN GOOD CONDITION. INACCURATE FLOWS. DISSASSEMBLED THE CONNECTOR AND FOUND THAT THE RETAINING LOCK ON PIN 10 WAS BROKEN. REPLACED THE CONNECTOR TO REPAIR THE PROBLEM, BUT NO CORRECTIVE ACTION IS POSSIBLE BECAUSE CO COULD NOT FIND A CAUSE OF WHY THE RETAINING LOCK WAS BROKEN OFF THE CONTACT. UNIT WAS MILLED BY THE DRAWER DOGHOUSE TO PREVENT THE DRAWER WIRE FROM BEING PINCHED. A FLOW ARROW AND A CABLE LABEL WAS ADDED FOR BETTER VISUAL IMAGE. UNIT WAS CLEANED AND FINAL TESTED.
PORT SEPARATED FROM CATHETER AFTER IMPLANTATION.
RIGHT INTERNAL JUGULAR VEIN 2/26/96 CRACKED INTO THREE PIECES WHEN PT VOMITED. THIS OCCURRED ONE HOUR POST MITRAL VALVE SURGERY. PT BLED.
BULB OF SURGICAL DRAIN CONTAINER SEPARATED INTO TWO SECTIONS. DRAIN AND BULB PLACED DURING SURGERY ON 2/13/96.
INTESTINAL DECOMPRESSION TUBE PULLED BY DOCTOR. THE END OF THE TUBE WITH MERCURY WAS NOT RELEASED WITH THE REMAINDER OF THE TUBE. THEREFORE, THE MERCURY WAS INTERNAL AND EXTERNAL.
THE PT WENT TO SURGERY FOR AN EXPLORATORY LAPAROSCOPY. A #5 LAPAROSCOPIC TROCAR WAS PLACED AND VISUALIZATION OF THE PELVIS WAS ATTEMPTED. DUE TO THE FAULTY NATURE OF THE EQUIPMENT AN ATTEMPT WAS MADE WITH A LARGER SCOPE. A #8 TROCAR WAS PLACED THROUGH THE INCISION WHERE THE #5 HAD BEEN PLACED PREVIOUSLY WITH THE FIRST SCOPE. NO VISUALIZATION WAS POSSIBLE. A SECOND SCOPE WAS USED AND PLACED IN THE ABDOMEN. IT WAS "CLOUDY." THEREFORE THE LAPAROSCOPE WAS "JETTISONED" DUE TO THE INABILITY TO SECURE FUNCTIONAL EQUIPMENT. THE PERIUMBILICAL INCISION WAS CLOSED AND A SUPRAPUBIC INCISION WAS MADE AND A MINILAPAROTOMY WAS DONE.
FAILED PENILE IMPLANT FLUID LEAKAGE FROM DEVICE. REQUIRED SURGERY TO REPLACE.
THE VENTILATOR WAS BEING USED IN RPTR'S SPECIAL CARE NURSERY. THE VENTILATOR WAS PLUGGED INTO AN UNINTERRUPTIBLE POWER SUPPLY (UPS). THE UPS POPPED AND LOST POWER. THE VENTILATOR HAD TO BE UNPLUGGED FROM THE UPS AND PLUGGED INTO AN ELECTRICAL OUTLET. THE PT WAS NOT AFFECTED BY THIS. LOSS OF POWER TO NEONATAL VENTILATOR COULD POSSIBLY BE LIFE-THREATENING. UPS IS THE BATTERY BACKUP'S POWER SOURCE.
DURING REMOVAL OF DRAINS, THE DRAIN IN THE RIGHT UPPER QUADRANT OF ABDOMEN FRAYED CAUSING A SEGMENT OF SILASTIC TUBING TO REMAIN IN THE SUBCUTANEOUS TISSUE. ATTEMPTS TO RETRIEVE WERE NOT SUCCESSFUL AT THAT TIME. ON 8/3/95, PT WAS ADMITTED TO SHORT PROCEDURE UNIT AND RETAINED FRAGMENT OF DRAIN WAS REMOVED UNDER ANESTHESIA.
PT HAD RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY ON 8/26/94. POLYETHYLENE INSERT WORN AWAY, PT HAD METAL TO METAL WEARING.
HAPTIC ON LENS WAS BENT BACK ON ITSELF AND WOULD NOT OPEN TO HOLD IOL IN PLACE.
PROBLEM WITH PACER. PRE-OP DIAGNOSIS, PACEMAKER LEAD FRACTURE. CO SERVICE TECH STATES PTS "USUALLY NEED TO BE REPLACED AFTER 5 YEARS." CO ADVISES "NO HEAVY LIFTING/ACTIVITY." PT STATES SHE "WAS SHOVELING SNOW AND FELT PROBLEM WITHIN A FEW DAYS."
BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMY LEFT.
BILATERAL BREAST EXCHANGE WITH CAPSULECTOMIES.
WHEN SYRINGE IS LOADED INTO PCA PUMP, THE PLASTIC SAFETY CAP ON THE SYRINGE CAN FALL INTO THE WELL WHERE THE PUSHER BLOCK ASSEMBLY DRIVES THE SYRINGE FORWARD. AS THE PUSHER BLOCK ASSEMBLY IS DRIVEN FORWARD BY THE MOTOR AND THE THREADED SCREW, IT CAN JAM AGAINST THE SAFETY CAP. THIS CAUSES AN OCCLUSION OF THE PUSHER BLOCK ASSEMBLY AND STOPS DELIVERY OF MEDICATION. IF THE OCCLUSION PRESSURE ALARM MICROSWITCH IS SET LOW ENOUGH, IT WILL ALARM. IF NOT, IT WILL STRIP THE THREADS IN THE PUSHER BLOCK ASSEMBLY. THERE HAVE BEEN 16 FAILURES OF THE HALF-NUT, PUSHER BLOCK ASSEMBLY WITH 29 PCA PUMPS OVER A PERIOD OF 7 YEARS FROM JAMMING AGAINST SYRINGE SAFETY CAPS IN THE SYRINGE TRAY.
THE INTRA-AORTIC BALLOON PUMP ALARMED, AND BLOOD WAS NOTED IN THE EXTRACORPORAL TUBING INDICATIVE OF A BALLOON LEAK. THE BALLOON WAS DISCONTINUED 1 HOUR LATER.
WHILE ATTEMPTING TO SEAL THE SHARPS CONTAINER LID, PT PLACED PALMS OF HIS HANDS ON THE ROUND LID AND APPLIED PRESSURE TO SECURE THE TOP. WHILE APPLYING PRESSURE, THE CENTER SECTION OF THE LID COLLAPSED INTO THE INSIDE OF THE SHARPS CONTAINER. THE COLLAPSE OF THE LID PRODUCED A JAGGED EDGE THAT PUNCTURED THE LEFT WRIST OF PT. (LEAVING A CUT ABOUT 1/8"). PT'S HAND WENT INTO THE FILLED SHARPS CONTAINER WHICH WAS USED IN RPTR'S NEEDLE EXCHANGE PROGRAM.
FILTER FOUND TO BE FAULTY. NO CONNECTOR AT ONE END AND NO CLAMP. (*)
THE WIRE ON THE VAPORIZER CAUGHT ON FIRE. THIS HAPPENED WHILE IT WAS PLUGGED IN AND WHILE RPTR WAS SLEEPING.
RPTR'S DRESSING FOUND SATURATED. QUESTIONS IF CATHETER LEAKING. SUBCUTANEOUS EXTRAVASATION OF ADRIAMYCIN. PT COMPLAINING OF PAIN AT SITE. CATHETER REMOVED. NO VISIBLE INJURY TO THE PT AT TIME OF DISCHARGE.
ON 1/11/96 DURING A TELEPHONE CONVERSATION WITH THE PT'S DAUGHTER, HOSP DISCOVERED THAT A PACEMAKER INSERTED AT FACILITY HAD PERFORATED THE ATRIUM AND THE PT REQUIRED SURGERY. THE CASE WAS DISCUSSED DURING PEER REVIEW MEETING AND FELT NOT AN MD USER ERROR. THE LEAD WIRE WAS OF THE "SCREW-IN" TYPE AND THE LENGTH OF THE SCREW MAY HAVE CONTRIBUTED. THE CARDIOLOGIST HAS SPOKEN WITH THE CO. IT IS DIFFICULT TO EXAMINE OUTCOME AND HOSP HAS NOT BEEN PERMITTED ANY RECORDS FROM THE FACILITY PT WAS TRANSFERRED TO THE PT WAS DISCHARGED HOME HOWEVER.
THIS IS A FOLLOW UP REPORT TO CORRECT SOME MISINFORMATION. A FORMALDEHYDE SPILL- PRESUMED 37% OCCURRED IN THIS DIALYSIS FACILITY. TWO SOURCES WERE IDENTIFIED- A LEAKING SEAL ON A REUSE CART AND A SPILL DOWN THE BACK OF A SHELVING UNIT. THE UNIT WAS EVACUATED BUT NO ONE WAS SENT TO THE HOSP.
VENT SUDDENLY WENT INOP SHOWING CODE E 64. PT BAGGED UNTIL NEW VENT BROUGHT UP.
RPTR C/O: LOW BLOOD PRESSURE, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES, BLOOD TESTS INDICATE POSSIBLE CANCER OF BLADDER, CHEST/RIB CAGE PAIN &/OR BURNING SENSATION, INFLAMMATION OF BREASTS AND UNDERARMS, VITILIGO SKIN DISEASE WHICH CAN AFFECT EYES, CHRONIC SWELLING AND PAIN, HEAT OR COLD SENSITIVITY OF EXTREMITIES, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, HYSTERECTOMY, FREQUENT MIGRAINES/SEVERE HEADACHES, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS AND MOLDS, DUST OR POLLEN, CONNECTIVE TISSUE DISEASE, JOINT INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, PERSISTENT JOINT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY UNDER ARMS, CHRONIC UNEXPLAINED MUSCLE SPASMS, MUSCLE PAIN & BURNING, SUN SENSITIVITY, DERMATOMYOSITIS, VITILIGO, FUNGAL RASH, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPS THINGS AND MISJUDGES DISTANCE/RUNS INTO OBJECTS. OSTEOARTHRITIS (94), HYPOTHYROIDISM (94), INTERSTITIAL CYSTIS W/HUNNERS ULCERS (94).
PT HAD PTCA. DISTAL TIP OF GUIDEWIRE SEPARATED FROM BODY OF WIRE AND MIGRATED TO DISTAL PORTION OF A CORONARY ARTERY. PT HAD CABG; UNABLE TO RETRIEVE TIP. MFR NOTIFIED BY CARDIAC CATH LAB.
CDOMPLAINANT REPORTS FITNESS CENTER, HAS TANNING BEDS WHICH ARE UNSUPERVISED, NO EYE GOGGLES, BROKEN PLASTIC ON BEDS OVER UV BULBS, UNLIMITED SESSIONS AND QUESTIONS ABOUT LABELING/DIRECTIONS.
PHLEBOTOMIST WAS DRAWING BLOOD FROM HIV PT. UPON FINISHING BLOODCULTURES, SHE BEGAN ISOLATOR TUBES FOR AFB. SHE FILLED FIRST ISOLATOR AND THEN TOOK SECOND ISOLATOR TO FILL IT BUT ENCOUNTERED DIFFICULTY. AS A RESULT SHE USED A 10 CC SYRINGE AND NEEDLE TO SPARE THE PT ANOTHER STICK.THE PHLEBOTOMIST UPON DRAWING THE BLOOD, SUBSEQUENTLY INSERTED THE NEEDLE INTO THE STOPPER OF THE ISOLATOR TUBE. SHE PICKED THE TUBE UP WITH HER RIGHT HAND AND TAPPED THE PLUNGER OF THE SYRINGE WITH HER LEFT THUMB TO GET IT STAERTED. AND SHE DID THIS, THE TUBE EXPLODED SENDING A PRESSURIZED MISTY SPRAY OF BLOOD INTO HER FACEAND EYES. THE TUBE AND SYRINGE WERE PLACED IN THE BIOHAZARD BUCKET ON THE WALL OF THE PT'S ROOM. THE BOX WAS LATER IMPOUNDED. THE EMPLOYEE PHLEBOTOMIST FKUSHED HER EYES WITH WATER AND THEN SOUGHT TREATMENT IN THE EMERGENCY DEPARTMENT. THE MFG REPRESENTATIVE WAS NOTIFIED AND THE REMAINING TUBES OF THE LOT IMPOUNDED.
A ONE-MONTH OLD MALE, BORN AT 35 WEEKS GESTATION WITH NUMEROUS CONGENITAL DEFECTS INCLUDING CCLEFT PALATE, L. HYDRONEPHROSIS, CHOLEDOCHAL CYST, AORTIC COARCTATION, R. HYDROCELE. CVC LINE PLACED AT ST JOHN'S HOSP 10/5 WAS TRANSFERRED TO FACILITY ON 10/22/95 FOR CARDIAC SURGERY (10/24) TO REPAIR COARCTATION OF AORTA. ON 10/30/95, IT WAS NOTED DURING TRANSFUSION THAT THE CATHETER HAD A LARGE HOLE. PERIPHERAL IV WAS INSERTED. PT WAS SUBSEQUENTLY TAKEN TO SURGERY FOR REPLACEMENT OF THE CENTRAL VENOUS CATHETER. THE CVC LINE HAD BEEN PLACED AT ANOTHER FACILITY.
PT IN HAVING ESOPHAGEAL VARICES. EGD-DEMONSTRATED LARGE VARICES AGAIN SEEN X 4 IN DISTAL ESOPHAUS. THERE WAS NO EVIDENCE OF ACSTIVE BLEEDING. THE STOMACH WAS ENTERD, AGAIN WAS FREE OF ULCERATIONS. THE STOMACH DID NOT SHOW MULTIPLE PETACHIAL LESIONS SUGGESTIVE OF ANGIODYPLASTIC LESIONS OF GASTRITIS. THE ENDOSCOPE WAS THEN PULLED BACK INTO THE ESOPHAGUS. TEH OVERTUBE WAS ADVANCED OVER THE ENDOSCOPE. THE ENDOSCOPE WAS THEN REMOVED AND THE BANDING APPARATUS REPLACED OVER THE END OF THE ENDOSCOPE. THE ENDOSCOPE WAS THEN RE-INTRODUCED THROUGH THE OVERTUBE AND INTO THE ESOPHAGUS AND DOWN TO THE DISTAL ESOPHAGUS. THERE, ONE VARICE WAS IDENTIFIED AND PROPERLY BANDED WITHOUT DIFFICULTY. AT THIS POINT THE ENDOSCOPE WITH THE BANDING DEVICE WAS WITHDRAWN. ATTEMPTS TO WITHDRAW IT THROUGH THE OVERTUBE WERE PROVED IMPOSSIBLE AND THEREFORE, THE ENTIRE OVERTUBE AND ENDOSCOPE NEEDED TO BE REMOVED. UPON REINTRODUCING THE ENDOSCOPE THROUGH THE OROPHARYNX, RPTR DISCOVERED A LARGE DEFECT IN THE ESOPHAGUS APPROX 2.5 CM BEYOND THE VOCAL CORDS. THE VOCAL CORDS WERE UNDISTURBED AND NORMAL. THE DEFECT WAS IN THE FORM OF A POUCH AND BECAUSE OF CONCERN OF A PERFORATION, RPTR IMMEDIATELY CONSULTED THE CHIEF OF SURGERY AND THE CHIEF OF SURGERY AND THE CHIEF OF ENT, WHO BOTH CONFIRMED THE DEFECT. THE DECISIONS OF THE SURGEONS WAS TO TERMINATE THE STUDY AND PROCEED WITH FURTHER EVALUATION OF THIS POSSIBLE ESOPHAGEAL TEAR. A GASTROGRAFIN ESOPHAGEAL SWALLOW WAS PERFORMED WHEN THE PT WOKE UP AND THE TEAR WAS CONFIRMED. THE PT WAS RETURNED TO SURGERY FOR REPAIR OF THE ESOPHAGUS. DRAINAGE TUBE INSERTED AND PT INTUBATED AND ON VENTILATOR POST OP DUE TO DIFFICULT INTUBATION DUE TO OSTEOARTHRITIS, DUE TO ANTICIPATED LARYNGEAL EDEMA PT LEFT INTUBATED.
PT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY DURING 9/90. PT SUSTAINED RECURRENT DISLOCATIONS OF THE PROSTHESIS AND WAS ADMITTED TO THE HOSP FOR OPEN REDUCTION OF THE LEFT HIP WITH REPLACEMENT OF PLASTIC ACETABULAR LINER AND FEMORAL HEAD AFTER REDUCTION IN THE E.R. WAS UNSUCCESSFUL. THE PT IS STATUS POST CEREBROVASCULAR ACCIDENT AND WAS NOTED TO BE A POOR HISTORIAN.INTRAOPERATIVELY, THE ACETABULAR LINER WAS REPLACED WITH A LINER OF THE EXACT TYPE. THE HEAD OF THE FEMORAL COMPONENT WAS REMOVED WITHOUT DIFFICULTY. IT WAS REPLACED AND SECURED WITH A MALLET. INTRAOPERATIVE CULTURES WERE OBTAINED WHICH WERE FOUND TO BE NEGATIVE FOR ORGANISM GROWTH. THE ACETABULAR COMPONENT WAS FOUND TO BE IN 20 DEGREES RETROVERSION.
PT INVOLVED IN MOTOR VEHICLE ACCIDENT DURING 2/95, SUSTAINED A FEMUR FRACTURE. THE FRACTURE WAS ORIGINALLY TREATED WITH A NAIL AND LATER NAIL WAS EXCHANGED FOR ANOTHER TYPE NAIL. THE PT WAS UP AND FELT A "POP" AGAIN THROUGH THE THIGH AND EXPERIENCED AN INCREASE IN SYMPTOMS OF PAIN OF LEFT THIGH. RADIOGRAPHIC EXAMINATION SHOWED A WIDENING OF THE GAP THROUGH THE THE NAIL AND CALLOUS FORMATION HAD SHEARED OFF. PHYSICAL EXAMINATION OF THE PT REVEALED EXTREME PAIN UPON ANY RANGE OF MOTION OF THE THIGH. THE PT WAS ADMITTED TO THE HOSP, THE HARDWARE WAS REMOVED AND NEW INTRAMEDULLARY ROD WAS PLACED. THE NAIL REMOVED WAS BROKEN. DISCUSSION WITH INDIVIDUALS INVOLVED IN PT'S CARE REVEALS THAT PT HAS A HISTORY OF MENTAL ILLNESS AND HAD NOT BEEN COMPLIANT WITH PHYSICIAN'S INSTRUCTION. DEVICE NOT CONSIDERED FAILED. BREAKAGE OF NAIL MAY HAVE BEEN CONTRIBUTED TO OVERUSE OF THE FEMUR.
PT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DURING 1987. PT HAS HAD PAINFUL GRINDING AND A "CATCHING" OF THE PATELLA FOR SEVERAL YEARS WITH SWELLING AND PAIN OF THE KNEE. PT HAS SIGNIFICANTLY DECREASED RANGE OF MOTION OF THE KNEE AND AMBULATION IS LIMITED. THE PT WAS ADMITTED TO THE HOSP FOR REVISION OF THE PATELLAR COMPONENT OF THE TOTAL KNEE PROSTHESIS. INTRAOPERATIVELY, THE PATELLA WAS REMOVED WITHOUT DIFFICULTY. THERE WAS WEAR NOTICED ON THE COMPONENT. THE TIBIAL INSERT WAS ALSO NOTED TO HAVE SIGNIFICANT WEAR. THE INSERT WAS REPLACED ALSO.
WHILE PLACING FOLDABLE LENS IN PT'S EYE, THE LENS RIPPED IN HALF. THIS OCCURRED MULTIPLE TIMES WITH LENS RANGING IN SIZE FROM 19.0 TO 21.0 DIOPTER. NO HARM TO PTS. LENS RETURNED TO MFR VIA SALES REP.
DURING SPINAL FUSION SURGERY, PORTION OF T-HANDLE INSTRUMENT BROKE OFF (TWO PIECES). NO HARM TO PT. INSTRUMENT BROKE OUTSIDE OF PT. BOTH PIECES RECOVERED.
PT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT DURING 1992 AT ANOTHER FACILITY. PT PRESENTED WITH COMPLAINTS OF PAIN DURING AMBULATION, WHICH HAD BEEN PRESENT SINCE THE TIME OF SURGERY, AND HAD CONTINUED TO PROGRESS. PT DID NOT HAVE "FULL CONTROL" OF PLACEMENT OF THE RIGHT FOOT. THE PT INITIALLY UNDERWENT PHYSICAL THERAPY AND WAS PLACED IN A LONG LEG CAST IN ATTEMPT TO IMPROVE JOINT STABILITY, HOWEVER, TREATMENT WAS NOT SUCCESSFUL. THE PT WAS ADMITTED TO THE HOSP FOR REVISION OF THE RIGHT TOTAL KNEE. INTRA-OPERATIVELY, APPROX 3 CM. OF MEDIAL-LATRAL INSTABILITY OF THE JOINT WAS FOUND. THE FEMORAL AND TIBIAL COMPONENTS WERE REMOVED WITHOUT DIFFICULTY. NO BONY INGROWTH WAS IDENTIFIED UPON REMOVAL OF THE COMPONENTS. THE COMPONENTS WERE REPLACED AND CEMENTED INTO POSITION. SURGEON'S OFFICE CONTACTED FOR MODEL, LOT, AND SERIAL NUMBERS OF PROSTHETIC DEVICE PLACED. NUMBERS LISTED WERE COMMUNICATED VIA TELEPHONE.
VENTILATOR BECAME UNOPERATIONAL AND DID NOT PASS EST SAFETY CHECK. PT NOT INJURED. MFR NOTIFIED AND REPAIRED UNIT FOLLOWING DAY.
PT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY DURING 7/95. PT WAS SUBSEQUENTLY TRANSFERRED TO A REHAB FACILITY WHERE SHE WAS LEARNING TO USE A WHEELCHAIR AND SUSTAINED A TWISTING INJURY TO THE EFT LOWER EXTREMITY. THE LEFT HIP DISCLOCATED. THE HIP WAS SUBSEQUENTLY REDUCED AND PT WAS TAUGHT TOTAL HIP RESTRICTIONS. PT RETURNED TO HOME AND SUSTAINED TWO DISLOCATIONS OF THE HIP ON TWO SEPARATE OCCASIONS WHILE SITTING ON THE COMMODE. ALL DISLOCATIONS WERE ANTERIOR. THE PT THEN SUSTAINED A THIRD DISLOCATION AND WAS ADMITTED TO THE HOSP FOR REVISION ARTHROPLASTY OF THE LEFT HIP. INTRAOPERATIVELY, A DARK, WATERY FLUID WAS FOUND WITHIN THE JOINT. CULTURES WERE OBTAINED AND REPORTED AS NEGATIVE FOR BACTERIAL GROWTH. THE ACETABULAR HEAD AND LINER WERE REMOVED AND THE ACETABULAR LINER WAS REPLACED. THE FEMORAL HEAD AND NECK WERE ALSO REPLACED.
ARTIFICIAL SPHINCTER WAS PLACED ABOUT 4-5 YEARS AGO WITH SATISFACTORY RESULTS. PT WITH RECURRENT BLADDER CARCINOMA WHICH WAS TREATED BY RESECTION AND SUBSEQUENTLY BY BCG THERAPY AND PROBABLY RELATED TO PASSAGE OF MULTIPLE INSTRUMENTS, PT DEVELOPED AN EROSION OF THE ARTIFICAL SPHINCTER INTO THE URETHRA AND IT WAS REMOVED. PT WAS ADMITTED FOR REINSERTION OF AN ARTIFICIAL SPHINCTER.
PT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY DURING 7/95 AND WAS DDISMISSED TO REHAB UNIT. PT PRESENTED ONE WEEK LATER AFTER SUSTAINING AN ANTERIOR DISLOCATION OF THE HIP. CLOSED REDUCTION OF THIS DISLOCATION WAS ATTEMPTED BUT WAS UNSUCCESSFUL. PT WAS ADMITTED TO THE HOSP FOR ARTHROTOMY OF THE LEFT HIP, REMOVAL OF SCREWS FROM THE ACETABULAR COMPONENT, ROTATION OF THE ACETABULAR COMPONENT MOST POSTERIORLY AND REVISION OF THE ACETABULAR LINER. INTRAOPERAIVELY, A HEMATOMA WAS FOUND PRESENT IN THE JOINT, WHICH WAS EVACUATED AND CULTURES WERE OBTAINED THAT WERE REPORTED NEGATIVE FOR BACTERIAL GROWTH. THE HIP WAS FOUND TO BE DISCLOCATED ANTERIORLY. THE CUP LINER WAS FOUND TO BE SECURE. THREE FO THE FOUR SCREWS WERE REMOVED FROM THE FLOOR OF THE ACETABULUM AND WAS MOVED INTO A MORE RETROVERSION AND HORIZONTAL POSITION.
PT HAS SALINE IMPLANTS (BREAST). PT WAS STRUCK IN CHEST BY AUTOMATIC DOOR. RUPTURED IMPLANT.
PT HAS A HISTORY OF RHEUMATOID AND GOUTY ARTHRITIS. PT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DURING 1988. PRESENTED WITH COMPLAINTS OF THE KNEE, DESCRIBING IT AS A "GRINDING" SENSATION AND FELT AS IF IT WERE "SLIPPING" WITH PAIN. PT STATED THE PROBLEM STARTED APPROX THREE TO FOUR WEEKS PRIOR TO PRESENTATION WHEN SHEA HAD AN ABSCESSED TOOTH. PT WAS PLACED ON ANTIBIOTIC THERAPY AT THAT TIME. THE KNEE BECAME PROGRESSIVELY MORE PAINFUL. PT WAS ADMITTED TO THE HOSP FOR REVISION OF THE KNEE AFTER THE  TOOTH HAD BEEN DRAINED AND DENTAL WORK COMPLETED. INTRAOPERATIVELY, METALLOSIS WAS IDENTIFIED AROUND SURFACE OF THE PATELLAR IMPLANT WAS SPLIT IN HALF AND LOOSE. THE LOOSE PLASTIC WAS REMOVED . ALL KNEE COMPONENTS WERE EMOVED AND REPLACED.
CAPSULAR FORMATION. PT C/O SORENESS, NO REPLACEMENT.
LEAKAGE OF RIGHT BREAST IMPLANT, DISCOMFORT. REPLACED WITH SALINE PROSTHESIS.
PT COMPLAINS OF PAIN OF THE RIGHT HIP OVER THE PAST SEVERAL MONTHS. RADIOGRAPHS REVEALED CHANGES CONSISTENT WITH LOOSENING OF THE STEM OF THE RIGHT TOTAL HIP ARTHROPLASTY. THE RIGHT LEG WAS FOUND TO BE SHORTENED DUE TO SUDSIDENCE OF THE FEMORAL COMPONENT. PT WAS ADMITTED TO THE HOSP FOR REVISION OF THE RIGHT TOTAL HIP. CAUSE OF LOOSENING UNDETERMINED AT THIS TIME. NOTE: PROSTHETIC LOT NUMBERS, CATALOG, AND SERIAL NUMBERS UNAVAILABLE.
PT C/O PAIN, DISCOMFORT. REQUESTS EXCHANGE; SILICONE WITH SALINE PROSTHESIS.
PT REQUESTED PROSTHESIS REMOVAL DUE TO PAIN.
REMOVAL OF SILICONE BREAST PROSTHESIS DUE TO PAIN, RUPTURE.
REMOVAL OF IMPLANT LEFT BREAST, D/C - 500CC SILICONE.
PT UNDERWENT INITIAL PLACEMENT OF RIGHT TOTAL HIP ARTHROPLASTY 1/4/90 AND REVISION OF TEH MODULAR HEAD AND NECK 4/9/91. PT SUSTAINED RECURRENT DISLOCATIONS, ON 10 OCCASIONS. THE MOST RECENT DISLOCATION WAS 8/6/95 WHEN THE PT WAS GETTING UP FROM THE COMMODE. REDUCTION WAS ATTEMPTED AT ANOTHER FACILITY WITHOUT SUCCESS. THE PT WAS SEEN IN THE EMERGENCY ROOM AND ADMITTED TO THE HOSP FOR REVISION OF THE RIGHT HIP. INTRAOPERATIVELY, IT WAS FOUND THAT THERE WAS ESSENTIALLY NO ATTACHMENT OF MUSCULAR TISSUE TO THE AREA OF HTE GREATER TROCHANTER. THE ACETABULAR LINER SHOWED ECCENTRIC WEAR AND THERE WAS SLIGHT RETROVERSION OF THE CUP. THE ACETABULAR SHELL AND LINER WERE REPLACED, AS WELL AS THE FEMORAL HEAD AND NECK.
REMOVAL OF BILATERAL BREAST IMPLANTS (SALINE). PT REQUEST.
PAIN LEFT BREST PROSTHESIS, QUESTIONABLE RUPTURE. (NO REIMPLANT.NO REIMPLANT
PT INITIALLY UNDERWENT RIGHT TOTAL KNEE REPLACEMENT 12/30/92 AND SUBSEQUENTLY UNDERWENT REVISION OF THE PATELLAR BUTTON 8/24/93. THE PT STATED THE RIGHT KNEE HAD BEEN STIFF AND PAINFUL SINCE THE INITIAL SURGERY. PREOPERATIVE RADIOGRAPHS OF THE RIGHT KNEE REVEAL IRREGULARITY OF THE POSTERIOR ASPECT OF THE PATELLA AND SOME NARROWING OF THE LATERAL ASPECT OF THE PATELLA FEMORAL ARTICULATION WITH JOINT EFFUSION. INTRA-OPERATIVELY, OVERGROWTH OF SOFT TISSUE WAS FOUND WITHIN THE JOINT AND THE PATELLA WAS ALMOST COMPLETELY OVERGROWN WITH SOFT TISSUE. PT HAD SIGNIFICANT EFFUSION, WHICH WAS ASPIRATED, AND THERE WERE LOOSE PIECES OF POLYETHYLENE WITHIN THE JOINT. THE POLYETHYLINE TIBIAL LINER WAS LOOSE. DELAMINATION WAS OCCURRING ON THE MEDIAL AND LATERAL TIBIAL PLATEAUS. A MODULAR FEMORAL COMPONENT AND  POSTERIOR STABILAIZED TIBIAL PLATEAU WERE PLACED.
REMOVAL OF BILATERAL BREAST SILICONE IMPLANTS. S/P RECONSTRUCTION AFTER BILATERAL MASTECTOMIES.
PT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY DURING 1974 FOR TREATMENT OF DEGENRATIVE ARTHRITIS. PT DID WELL UNTIL APPROX FOUR TO FIVE YEARS WHEN SHE BEGAN EXPERIENCING PAIN AND EVIDENCE OF BONE EROSION OFW THE LEFT HIP. THE HIP WAS REVISED DURING 2/95. MASSIVE BONE LOSS WAS FOUND MAINLY MDIAL AND SUPERIOR IN THE ACETABULAR REGION. A FEMORAL GRAFT WAS PERFORMED AT THAT TIME. SHORTLY THEREAFTER, THE PT SUSTAINED A DISLOCATION AND THE CUP WAS FOUND TO HAVE TURNED VERTICALLY. PT WAS PLACED ON CRUTCHES AS A MEASURE TO STIMULATE BONE GROWTH. THE PT WAS ADMITTED TO THE HOSP AFTER CHRONIC DISLOCATIONS OF THE HIP AND PERSISTENT BONE LOSS. THE PT WAS ADMITTED TO THE HOSP AND UNDERWENT REVISION OF THE FEMORAL HEAD, ACETABULAR LINER, AND REPLACEMENT OF ACETABULAR SCREWS. BONE GRAFT WAS PERFORMED.
COLLAGEN VASCULAR DISEASE, SJOGREN'S SYNDROME, LUPUS, RUPTURE LEFT BREAST PROSTHESIS.
SURGERY RELATED TO REPOSITIONING OF IMPLANT. PROSTHESIS FOUND TO HAVE LEAK UPON EXPLANT.
PT SUSTAINED FRACTURE OF LEFT TIBIA DURING 9/94. AN IM NAIL WAS PLACED IN THE FRACTURE SITE DURING OCTOBER, WITH WIRES. DURING NOVEMBER, THE PT'S FRACTURE PROGRESSED TO A NON-UNION. IN 1/95, FOLLOW-UP RADIOGRAPHS REVEALED HEALING OF THE FRACTURE SITE, HOWEVER, PT HAD MARKED ATROPHY OF THE CALF AND ANKLE AREA. THE PT WAS PLACED IN A WALKER AND A TENS UNIT WAS PLACED, ALONG WITH OTHER PHYSICAL THERAPY TREATMENT MODALITIES. PT UNDERWENT REMOVAL OF HARDWARE WIRES AND LOCALIZED BONE GRAFTING DURING 5/95. DURING JUNE, THE PT REPORTED STEPPING IN A HOLE AND HE HAD BEEN TAKING IBUPROFEN WITHOUT IMPROVEMENT OF THE PAIN. RADIOGRAPHS REVEALED A FATIGUE FRACSTURE OF THE TIBIAL NAIL AND A STRESS FRACTURE OF THE TIBIA. THE PT WAS PLACED IN A CAST BRACE AND WAS THEN ADMITTED TO THE HOSP FOR REMOVAL OF THE TIBIAL NAIL.
PAINFUL SCAR ENCAPSULATION RIGHT BREAST.
MEDICAL LABORATORY TECHNICIAN WAS PLACING THE RED STOPPER CAP ON A VACUTAINER TUBE WHEN THE TUBE BROKE, CAUSING THE TECHNICIAN TO SUSTAIN A PUNCTURE/LACERATION TO THEE LEFT INDEX FINGER. THE PT BLOOD SOURCE WAS KNOWN TO BE HEPATITIS C POSITIVE. THE EMPLOYEE WAS DISCOVERED TO CONVERT POSITIVE TO HEPATITIS C (RNA) 8/22/95. THE EMPLOYEE HAD BEEN GIVEN A FULL SERIES OF HEPATITIS B SHOTS IN THE PAST. FOLLOWING EXPOSURE, THE EMPLOYEE WAS GIVEN A BOOSTER HEPATITIS B INJECTION, IN ADDITION TO A TETANUS TOXOID. PT WAS SUBSEQUENTLY GIVEN A TOTAL OF 4.8 CC'S OF H-BIG, SEPARATED INTO TWO DOSES, PRIOR TO SEROCONVERSION. THE DATE THE INCIDENT OCCURRED WAS 6/20/95.
CAPSULE FORMATION, RUPTURED RIGHT IMPLANT AND LEFT.
REMOVAL OF LEFT BREAST SALINE IMPLANT, LEAKAGE. (AUGMENT ORIGINAL).
PT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY DURING 1987 AT ANOTHER FACILITY. PT PRESENTED WITH COMPLAINTS OF SEVERE INSTABILITY, PAIN, AND RECURRENT EFFUSIONS OF THE KNEE. RADIOGRAPHIC EXAMINATION OF THE KNEE REVEALS ANTERIRO SUBLUXATION OF THE FEMUR ON THE TIBIA AND SLIGHT LATERAL SUBLUXATION OF THE PATELLA. INTRAOPERATIVELY, THE SYNOVIUM WAS FOUND TO BE "BROWN AND STAINED". POLYETHYLENE WEAR WAS QUITE SEVERE. THE PATELLA WAS COMPLETELY LOOSE AND PULLED OUT, METAL BACKING AND ALL. THE POLYETHYLENE HAD FAILED ON THE TIBIA, PARTICULARLY MEDIALLY. FRAGMEENTS OF POLYETHYLENE WERE FOUND WITHIN THE JOINT SPACE. ALL TOTAL KNEE COMPONENTS WERE REMOVED AND REPLACED. COPIES OF OPERATIVE REPORT AND RADIOGRAPHS REQUESTED FROM SURGEON WHO PERFORMED INITIAL SURGERY BUT REPORTS HAVE NOT YET BEEN REC'D.
CAPSULE FORMATION RIGHT BREAST PROSTHESIS. S/P LYMPECTOMY FOR CANCER RADIATION THERAPY. RIGHT BRESAT
PT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY DURING JUNE, 1992. PT PRESENTED WITH COMPLAINTS OF PAIN OF THE LEFT KNEE, PRESENT FOR APPROX FIVE MONTHS WIH ONE EPISODE OF KNEE GIVING WAY. IT WAS FELT THERE WAS NO SIGNIFICANT EVIDENCE OF INFECTION OR LOOSENING OF THE METAL COMPONENTS AND THAT A TIBIAL IMPLANT SPACER MAY HAVE FAILED. THE PT HAD EXTENSOR MECHANISM DAMAGE AS WELL, CAUSING PAIN AND TENDERNESS WITH FLEXION AND EXTENSION OF THE KNEE. THE PT WAS TAKEN TO SURGERY FOR SYNOVECOMY OF THE KNEE AND REPLACEMENT OF THE TIBIAL SPACER. INTRAOPERATIVELY, BROWNISH SYNOVIAL FLUID WAS NOTED. CULTURES OF THE FLUID WERE OBTAINED, WHICH WERE REPORTED AS NEGATIVE FOR BACTERIAL GROWTH. THERE WAS A SMALL TEAR OF THE EXTENSOR MECHANISM THAT DID NOT REQUIRE REPAIR. THE TIBIAL COMPONENT WAS LAX. A 15 MM. TIBIAL IMPLANT SPACER WAS INSERTED.
PT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DURING 1987. PT DID WELL UNTIL APPROX ONE YEAR AGO WHEN SHE BAGAN TO EXPERIENCE "GIVING WAY" OUT OF HER KNEE AND REPORTED THAT IT WAS "GOING OUT OF SOCKET". EXAMINATION REVEALED THE PT HAD A HYPERMOBILE JOINT. THE KNEE WAS FELT TO BE UNSTABLE AND SOME EFFUSION WAS PRESENT. THE PT WAS ADMITTED TO THE HOSP FOR REVISION OF THE RIGHT TOTAL KNEE. INTRAOPERATIVELY, AN EXTENSIVE AMOUNT OF BLACK SYNOVIUM PRESENT THROUGHOUT THE JOINT, FELT TO BE FFROM THE PREVIOUS PLACED CARBONIZED TIBIAL INSERT. INTRAOPERATIVE AEROBIC AND ANAEROBIC CULTURES REVEALED NO ORGANISM GROWTH. THE KNEE WAS DEBRIDED AND THE FORMAL, TIBIAL, AND PATELLAR COMPONENTS WERE REMOVED AND REPLACED.
PT SUSTAINED AN OPEN TIBIA-FIBULA FRACTURE APPROX ONE YEAR AGO AND INITIALLY UNDERWENT NAILING OF THE LEFT TIBIA. PT SUBSEQUENTLY DEVELOPED A NON-UNION AND UNDERWENT REMOVAL OF THE IM ROD AND PLATE WITH B0NE GRAFTING. THE FRACTURE SEEMED TO BE APPARENTLY CLINICALLY HEALED, HOWEVER, PT DEVELOPED SOME FATIGUE PAIN AROUND THE FRACTURE SITE AND EVENTUALLY HARDWARE FATIGUE WITH A BROKEN PLATE. RADIOGRRAPHS REVEALED INCOMPLETE NONUNION OF THE FRACTURE SITE. THE PT WAS ADMITTED TO THE HOSP FOR REMOVAL OF THE BROKEN PLATE, SCREWS, AND INTRAMEDULLARY RODDING OF THE TIBIA WITH FIBULAR OSTECTOMY.
APPROX 10 MIN AFTER INDUCTION OF ANESTHESIA, THE PT WAS BELIEVED TO HAVE BEEN RECEIVING 7-10% SUPRANE & NO 2. PT BEGAN TO MOVE. CIRCUIT WAS DISCONNECTED ON MACHINE END. NO ODOR OF VOLATILE ANESTHESIA AGENT WAS DETECTED. VAPORIZER REMOVED FROM SERVICE.
PT RECEIVED DEFIBRILLATOR BURNS, ANT & POST. AFTER 200 JOULE SHOCK DELIVERED USING FORT PATCHES. PICTURES TAKEN & WITH INCIDENT REPORT. PT WILL NEED MEDICATION SOLVE/CREAM FOR BURNS. BURNS ANTERIOR & POSTERIOR AFTER 200 JOULES HAD BEEN DELIVERED USING FAST PATCHES. PT WILL NEED MEDICATION, A SALVE OR CREAM, FOR BURNS.
WHEN THE PRODUCT IS CONNECTED TO THE MEDICATION VIAL AND THEN TO THE IV BAG, THE BAG IS TO BE BENT IN HALF AND APPLIED TO "POP" THE STOPPER OUT OF THE CONNECTOR AND INTO THE VIAL, ENABELING USED TO SQUEEZE FLUID INTO THE VIAL FOR MIXING. THEN THE VIAL AND BAG. RPTR IS HAVING TROUBLE WITH THE STOPPER IN THE CONNECTOR NOT COMPLETELY DISLODGING INTO THE VIAL AND THEN SETTING SUCKED BACK INTO THE CONNECTOR AND LODGED THERE. THIS KEEPS THE FLUID THAT HAS BEEN SQUEEZED INTO THE VIAL FROM BEING "MILKED" BACK INTO THE IV BAG. THIS WASTES THE VIAL OF MEDICATION AND THE IV BAG AS WELL AS NURSING AND PHARMACY TIME.
DURING BALLOON DILATATION OF LEFT POPLITEAL ARTERY, THE BALLOON PORTION OF THE CATHETER BURST. A SUBSEQUENT BALLOON DILATATION CATHETER WAS USED. SUCCESSFULLY. UNABLE TO DETERMINE IF ANY BALLOON FRAGMENTS WERE RETAINED.
CLASP WHICH HOLDS STERILE SLEEVE ON SUCTION CATHETER IS SHARP AND POKES HOLE IN STERILE PACKAGE, RENDERING IT NON-STERILE. IT ALSO HAS CUT A NURSE'S THUMB.
THE PT SUFFERED CARDIOPULMONARY ARREST WHILE ON THE MACHINE. THE PT IS NOW BEING EVALUATED AND IS PROBABLY GOING TO DIE.
RPTR C/O ITCHING, WATERING EYES, BRONCHITIS AND SKIN REDDENING. IT STARTED WITH THE PESSARY AND CONTINUED WITH THE GLOVES. (ALSO SEE 1008563)
RPTR C/O ITCHING, WATERING EYES, BRONCHITIS AND SKIN REDDENING. IT STARTED WITH THE PESSARY AND CONTINUED WITH THE GLOVES. (ALSO SEE 1008562)
NEAR THE END OF RPTR'S DENTAL EXAM AND CLEANING, HER NOSE BEGAN TO RUN, SHE HAD MILD ITCHING IN HER HANDS AND HER MOUTH BECAME SORE AND FELT SWOLLEN. SHE LOOKED IN THE MIRROR AND SAW A SKIN TEAR, ABOUT 1 CM, WITH SURROUNDING EDEMA. SYMPTOMS RESOLVED WITHIN 1/2 HOUR. THE DENTIST WAS USING VINYL GLOVES AND THERE WERE NO OTHER RUBBER PRODUCTS IN THE AREA. RPTR AND DENTIST THINK THE TIP MAY BE LATEX AND THAT THE REACTION WAS DUE TO LATEX.
PT HAD ELECTRIC SHOCK THERAPY IN 12/59. PT HAS HAD CONTINUOUS HEADACHES SINCE. PT HAS ALSO SUFFERED MAJOR, PERMANENT MEMORY LOSS. (*)
PT SUFFERED SEVERE, PERMANENT MEMORY LOSS AFTER RECEIVING ELECTRIC SHOCK THERAPY.
RPTR EXPERIENCED PAIN IN HER HANDS, AND ARMS.
CAPACITOR "BLEW" CAUSING EXCESSIVE HEAT AND SMOKE IN AN ELECTRIC BED REQUIRING EVACUATION OF PT ROOM.
DEFECTIVE IV SET, LEAKS AT THE BOTTOM OF THE FILTER.
RPTR EXPERIENCED PAIN IN HER ARMS, DRY MOUTH, STOMACH PAIN, DIARRHEA, BLOOD VESSELS WERE BREAKING AND IT AFFECTED HER EYES. SHE ALSO C/O INFECTIONS, AND FATIGUE.
TUBING FOR MFR'S REPEATER PUMP RECENTLY REFORMULATED. THE TUBING NOW CAUSES LEAKAGE OF FLUID WHEN RPTR IS ATTEMPTING TO FILL ELASTOMERIC DEVICES RPTR'S. CONCERN IS POSSIBLE CONTAMINATION AND EXPOSURE OF ADMIXTURE PERSONNEL TO THE LEAKING FLUID.
CVP LINE WAS INSERTED. UPON REMOVAL OF GUIDE WIRE THERE WAS A SEPARATION OF THE WIRE & SPRING COVERING.
PT'S EXISTING VENOUS ACCESS DEVICE WAS ACCESSED BY A CANCER CENTER RN WITH A 19G NEEDLE. NO BLOOD RETURN. RN NOTED EDEMA DIRECTLY OVER PORT SITE. PT COMPLAINED OF PALPITATIONS OF HEART AND CHEST PAIN. M.D. NOTIFIED OF EVENTS AND ORDERS GIVEN TO SEND PT TO X-RAY DEPT FOR FLUOROSCOPIC VERIFICATION OF CATHETER IN RIGHT SUBCLAVIAN VEIN. X-RAY COULD NOT ACCOMODATE PT UNTIL LATER. ANGIOGRAPHY CONTACTED AND PT TAKEN TO ANGIOGRAPHY BY WHEELCHAIR. ANGIOGRAPHIC RETRIEVAL OF 10CM OF FRACTURED CATHETER FROM RIGHT ATRIUM AND VENTRICLE THROUGH RIGHT FEMORAL VEIN ACCESS.
RPTR'S PROBLEMS STARTED IN 1980 WITH PAIN AND HARDNESS OF BREAST. THE PLASTIC SURGEON TRIED TO ALLEVIATE THE PROBLEM BY MANIPULATING THE IMPLANTS MANUALLY. THIS WAS EXTREMELY PAINFUL. SHE C/O SEVERE ALLERGIES, JOINT PAIN, ARTHRITIS, LUPUS, MUSCLE WEAKNESS, EXTREME FATIGUE, NASAL ULCERS, EXCESSIVE AND FREQUENT VAGINAL BLEEDING, ALOPECIA, RASHES, FLU SYMPTOMS, BONE PAIN, PAIN, NUMBNESS TINGLING AND COLOR CHANGES IN EXTREMITIES, RHEUMATOID ARTHRITIS, BLEEDING DISORDER, RAYNAUD'S AND PERNICIOUS ANEMIA. SHE HADCAPSULAR CONTRACTURES IN 1982 AND 1995. HER IMPLANTS WERE LEAKING. BOTH SHE AND HER CHILD ARE VERY ILL. SHE HAS HAD TWO LAPAROSCOPIES AND SILICONE WAS FOUND IN HER UTERUS. PT C/O POLYUYOSITIS, POLYNEUROPATHY, PLEURISY, GRAND-MAL SEIZURES, MULTIPLE SCLEROSIS, SEVERE MULTIPLE CHEMICAL SENSITIVITIES.
MEDICAL DOCTOR NOTIFIED NURSE MANAGER OF BURN TO LEFT SIDE OF CHEST (SIZE OF A QUARTER) FROM PACER PATCH. THIS PATIENT WAS ON BOTH AN EXTERNAL PACER AND A PACER. (ALSO SEE 1008572)
MEDICAL DOCTOR NOTIFIED NURSE MANAGER OF BURN TO LEFT SIDE OF CHEST (SIZE OF A QUARTER) FROM PACER PATCH. THIS PATIENT WAS ON BOTH AN EXTERNAL PACER AND A PACER. (ALSO SEE 1008571)
NURSE WAS CHANGING EXTERNAL PACING PADS AND NOTED 3 SMALL ERASER-SIZED BURNS TO LEFT SIDE OF CHEST. MILLIAMP SETTING ON PACER WAS 81 AND RATE SET AT 60 BPM.
PT WAS IN CARDIAC CATH LAB FOR A PROCEDURE. THE CARDIAC CATHETER BROKE OFF IN THE AORTA. THE PT HAD TO GO TO OR FOR IT TO BE RETRIEVED.
RESIDENT WAS SITTING IN PT LIFT AND WAS BEING MOVED. THE CLIP WHICH HOLDS THE SLING/SEAT TO THE MAIN FRAME OF THE LIFT BECAME DISLODGED FROM ITS INSERT, CAUSING THE RESIDENT TO FALL ONTO THE FLOOR. THE FALL RESULTED IN A FRACTURED RIGHT SUPRACONDYLAR OF THE DISTAL FEMUR.
PT URINARY SPHINCTER IMPLANTED 1993 AND HAD SUBSEQUENT FAILURE OF PROSTHESIS RECENTLY.
HEARAEUS SURGICAL, 575 COTTONWOOD DR, MILIPITAS, CA 95035. THIS LETTER IS IN RESPONSE TO YOUR LETTER DATED 3/11/96, REFERENCING THE ABOVE ACCESS NUMBER AND MEDWATCH REPORT RECEIVED FROM A USER-FACILITY. ALTHOUGH OUR INVESTIGATION OF THIS INCIDENT IS NOT COMPLETE, OUR CURRENT DETERMINATION IS THAT THIS EVENT IS NOT REPORTABLE UNDER THE MEDWATCH REPORTING PROGRAM. THE CUSTOMER WAS CONTACTED IN AN ATTEMPT TO OBTAIN FURTHER INFO. NO INJURIES WERE REPORTED AS A RESULT OF THIS INCIDENT. IT WAS DETERMINED THAT THE LASER SYSTEM USED DURING THE INCIDENT WAS A LASER SONICS DEVICE, HOWEVER THE EXACT MODEL NUMBER WAS UNAVAILABLE. THE CUSTOMER REPORTED THAT SUBSEQUENT TO THE INCIDENT, THE LASER SYSTEM WAS SERVICED BY AN INDEPENDENT CONTRACTOR WHO DETERMINED THAT THE LASER SYSTEM WAS FULLY OPERATIONAL AND WITHIN SPEC. HERAEUS SURGICAL REQUESTED RETURN OF THE LASERSONCIS G56D LASER FIBER FOR EVALUATION. TO DATE, THIS FIBER HAS NOT BEEN RECEIVED. IF EVALUATION OF THIS FIBER CHANGES OUR MDR REPORTING DETERMINATION OF THIS INCIDENT, ADD'L INFO WILL BE SENT TO FDA AT THAT TIME. IF YOU HAVE ADD'L QUESTIONS, PLEASE CONTACT ME DIRECTLY AT: (408) 954-4208.
AT END OF RIGHT FEMORAL ABLATION (UNSUCCESSFUL), UPON REMOVAL OF RIGHT FEMORAL VENOUS SHEATH, THE SHEATH TORE. THE DISTAL END OF THE SHEATH REMAINED IN THE FEMORAL VEIN AND MIGRATED TOWARD THE ILIAC VEIN. OPERATOR ATTEMPTED TO RETRIEVE BY REMOVAL CUTDOWN BUT IT HAD MIGRATED TO THE COMMON ILIAC VEIN. BROKEN PIECE RETRIEVED UNDER FLUOROSCOPY WITH SNARING DEVICE. BLOOD LOSS 400CC. SCAR TISSUE FELT WITH INSERTION BUT NOT A DIFFICULT REINSERTION. 3500 U HEPARIN GIVEN FOR ABLATION PROCEDURE. SCAR TISSUE FELT TO BE FROM PREVIOUS ANGIOGRAPH.
STAPLER DID NOT FIRE PROPERLY. ANOTHER LOADING UNIT WAS PLACED IN THE STAPLER AND FIRED WITHOUT A PROBLEM.
SINCE THE 1980'S RPTR HAS EXPERIENCED MANY HEALTH PROBLEMS INCLUDING A DIAGNOSIS 7/94 OF ATYPICAL NEUROLOGICAL DISEASE FROM A BOARD CERTIFIED DOCTOR OF INTERNAL MEDICINE. ALSO PROOF OF RUPTURE BY MRI. NOW SCHEDULED FOR REMOVAL. RPTR OBJECTS STRONGLY TO A TIME LIMIT BEING PUT ON MFR LIABILITY. RPTR HAS SUCH FATIGUE, SHE DOES VERY LITTLE. SHE ONLY WORKS PART-TIME DUE TO OVERALL WEAKNESS. SHE JUST WANTS THIS POISON OUT OF HER BODY.
RPTR HAS BEEN EXPERIENCING UNEXPLAINED JOINT PAIN, CHRONIC FATIGUE, DEPRESSION AND RIGHT BREAST PAIN. SHE ALSO HAS FLU-LIKE EPISODES EVERY OTHER YEAR. LAST WERE 1992 AND 1995. INTRACAPSULAR RUPTURE DIAGNOSED ON MRI MAMMOGRAM SHOWED CALCIFICATION AND SLIGHT LOBULATION AND MILD CENTRAL FIBROGLANDULAR STROMAL PATTERN.
RESIDENT SLIPPED OUT OF SLING AND FELL TO FLOOR. ACCORDING TO MFR, THEIR REPRESENTATIVE CALLED THE FACILITY TO FIND OUT WHICH SLING WAS USED AND HOW IT FAILED. ON 2/15/96 RPTR RETURNED MFR REP'S CALL, STATING THAT IT WAS ANOTHER MFR'S SLING. RPTR SAID THE PT MADE HER OWN DECISION ON THE SLING AND THE WAY IT WAS TO BE USED. MFR'S LITERATURE STATES MFR'S SLINGS ARE TO BE USED WITH MFR'S LIFT.
RPTR STATES THERE WAS DIFFICULTY WHEN INSERTING AIRWAY. IT SEEMED TO SLIP JUST PAST THE TONGUE THEN GOT "HUNG UP." WHEN AIRWAY TUBE PUSHED IT WENT DOWN APPROPRIATELY. VALVE INFLATED AIR; INDICATOR BALLOON UP, TUBE HOOKED TO ANESTHESIA CIRCUIT AND VENTILATED WITHOUT RESPONSE. WHILE REMOVING AIR FROM CUFF, THE UPPER PART OF THE AIRWAY CAME OUT, APPEARING TO BE BROKEN AT JUNCTION OF MASK TO TUBE. REMOVED WITH FORCEPS. PIECES WERE FIT TOGETHER TO MAKE SURE NO PIECES WERE MISSING.
THE PT HAD A SCHEDULED EXPLANATION OF BILATERAL BREAST IMPLANTS.  THE RIGHT ONE 9IMPLANTED 5/1/910 WAS INTACT WITH NO PROBLEM.  THE LEFT ONE WAS SUSPECTED TO BE RUPTURED AND THIS WAS PROVEN AT TIME OF SURGERY.
DURING SURGERY, PT BEGAN HAVING BRONCHOSPASMS RESULTING IN A RIGHT PNEUMOTHORAX.  PT TREATED WITH IV EPINEPHRINE.
FAILED TOTAL HIP, LEFT. PT PRESENTED WITH BROKEN SCREWS IN THE ACETABULAR CUP PROSTHESIS. ACETABULAR CUP PROSTHESIS REPLACED AND 3 SCREWS REPLACED.
DURING THORASCOPIC LUNG RESECTION STAPLER FAILED ON 3RD FIRING (2ND REFILL) CAUSING BLEEDING OF THE LUNG AND THE NECESSITY OF TAKING ADDITIONAL TISSUE.
A CATHETER WAS INSERTED INTO THE RIGHT BASILIC VEIN. WHILE APPLYING STERI-STRIPS, PT COMPLAINED OF A FUNNY TASTE IN HER MOUTH AND STARTED BREATHING HEAVY. THEN PT COMPLAINED OF ITCHING. PT THEN BECAME RESTLESS AND MORE ANXIOUS. PT THEN DID NOT RESPOND TO VERBAL STIMULI AND A TEAM WAS CALLED. CATHETER WAS REMOVED. PT GIVEN IV FLUIDS WIDE OPEN AND OVER NEXT FEW MINUTES, RESPONSE IMPROVED AND 02 INCREASED FROM 64% TO 80'S. FEMALE PT'S AGE IS 38.
DURING CATHETERIZATION, WIRE BECAME LOCKED IN 90% OCCLUDED ARTERY. TIP OF WIRE UNRAVELLED AND BROKE OFF IN ANTERIOR LEFT DECENDING ARTERY. APPROX 16 CM LEFT IN PT. PT UNDERWENT EMERGENCY OPEN HEART SURGERY. PT DISCHARGED TO HOME 1/20/96.
BILATERAL CAPSULAR CONTRACTURE OF MAMMARY IMPLANTS.
CATHETER INSERTED WHEN PT BECAME SHORT OF BREATH AND BLOOD PRESSURE DROPPED. CHEST X-RAY SHOWED HEMOTHORAX ON LEFT. CHEST TUBE INSERTED TWICE. PT REQUIRED BLOOD PRODUCTS AND ICU STAY POST PROCEDURE. WHEN GUIDE WIRE WAS REMOVED, IT WAS FOUND TO BE "UNWOUND."
RESIDENT WAS SITTING IN LIFT AND WAS BEING MOVED. THE CLIP WHICH HOLDS THE SLING/SEAT TO THE MAIN FRAME OF THE LIFT BECAME DISLODGED FROM ITS INSERT, CAUSING THE RESIDENT TO FALL ONTO THE FLOOR. THE FALL RESULTED IN A FRACTURED RIGHT SUPRA CONDYLAR - DISTAL FEMUR.
EXPLORATORY LAP PERFORMED FOR POSSIBLE BOWEL LEAK, STAPLE LINE WAS NOT INTACT. PT EVENT WAS AN UNSCHEDULED RETURN TO SURGERY; WAS STATUS POST COLON RESECTION. AT RETURN THE BOWEL STAPLE LINE WAS NOT INTACT. MDR REPORTS STAPLE LINE FAILURE.
RESIDENT WAS BEING TRANSFERRED BACK TO BED VIA A LIFT FOLLOWING SHOWER. RESIDENT'S SKIN WAS MOIST FROM THE SHOWER AS WELL AS FROM AN INCONTINENT EPISODE, WHEREBY "LOOSE STOOL" WAS PRESENT ON THE LIFT PAD.
THE PT WAS CONNECTED TO A 250CC BAG OF HEPARIN THROUGH THE VOLUMETRIC INFUSION PUMP. THE PRIMARY INFUSION RATE OF THE PUMP WAS ESTABLISHED AT 13CC/HR. IT IS UNDETERMINED IF A SECONDARY INFUSION RATE HAD BEEN ESTABLISHED; HOWEVER, IT IS UNDERSTOOD THAT THE SECONDARY INFUSION RATE WAS NOT USED IN THE TREATMENT OF THIS PT. THE PT WAS TRANSPORTED TO ANOTHER DEPARTMENT WITH APPROX 75CC REMAINING IN THE HEPARIN BAG. WITHIN ONE HOUR OF TRANSPORT, THE NURSING COORDINATOR WAS CONTACTED AND DETERMINED THE BAG WAS EMPTY; CAUSING THE AUDIBLE ALARM. AFTER ESTABLISHING A NEW BAG OF HEPARIN INTO THE PUMP, THE NURSE RESPONSIBLE FOR THE CARE OF THIS PT NOTICED THE INFUSION RATE WAS SET FOR 700CC/HR. THE PT WAS QUESTIONED AND STATED THAT HE DID NOT TAMPER WITH THIS UNIT. ALL STAFF INVOLVED IN THE CARE OF THIS PT STATED THAT THEY DID NOT ADJUST THE SETTING. IT IS UNDETERMINED AS TO HOW THE RATE CHANGED FROM 13CC/HR TO 700.
UPON HOOKING PT UP TO PUMP AFTER INSERTING NEEDLE INTO PORT, PT STATED "I FEEL LIKE I AM HAVING A HEART ATTACK." THE NURSE AND PT EXPERIENCED WHAT THEY DESCRIBED AS A SHOCK.
PAD ON PT DID NOT STICK WELL AND A BURN (SIZE OF A QUARTER) NOTED ON RIGHT THIGH. ALSO AREA WHERE PAD STUCK WAS RED. BURN THIRD DEGREE.
CONSUMER REPORTED THAT HE GOT HIGH READINGS ON THE BLOOD PRESSURE KIT. HE SAID HE WOULD WAIT ABOUT 5 MINUTES AND THEN TAKE HIS BLOOD PRESSURE AGAIN FIVE TO SIX TIMES AND WOULD THEN GET A NORMAL READING. HE SAID HE TAKES HIS BLOOD PRESSURE DUE TO HEART PROBLEMS, DIABETES, ETC, AND THAT HE IS TRAINED IN HOW TO TAKE HIS OWN BLOOD PRESSURE. PER PHONECALL ON 1/11/96 WITH THE  PHARMACY MANAGER AT ANOTHER DRUGSTORE, HE VERIFIED THAT IT DOES CARRY THIS BRAND OF BLOOD PRESSURE KITS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED. HE ADDED THAT HE HAS ONE OF THESE AND HE TAKES IT WITH HIM AND HIS DAUGHTER TO THE HOSP AND FINDS IT TO BE VERY ACCURATE. A COMPANY REP REPORTED THAT THE COMPANY DOES RECEIVE A "STEADY BUT SMALL" NUMBER OF COMPLAINTS ON THIS PRODUCT. THE COMPLAINTS USUALLY ARE RELATED TO THE READINGS BEING EITHER TOO HIGH OR TOO LOW. HE SAID THERE ARE A NUMBER OF DIFFERENT FACTORS THAT CAN AFFECT THE READING.
RPTR'S CONDITION WAS DIAGNOSED AS "LUMBAR STENOSIS LEVEL INFERIOR ASPECT FROM L3 THROUGH L5 WITH SCOLIOSIS AND SPONOYLOTHESIS AT L4-L5, L5-S1." HE WAS OPERATED ON 4/3/95 BY A DOCTOR WHO, IN HIS OPINION IS A COMPETENT SURGEON. THE ONLY COMPLICATION OF THE SURGERY WAS A PULMARY EMBOLI. THE PROCEDURE PEFORMED WAS DECOMPRESSION, LUMBAR AND LUMBOSACRAL FUSION, LATERAL TRANSVERSE PROCEDURE USING RODS, PEDICLE SCREWS AND CROSS LINES. FROM 4/19/95 TO 5/20/95, HE WALKED DAILY (AS RECOMMENDED BY HIS DOCTOR) TO HELP HEAL THE FUSION. HE WAS ABLE TO WALK 2 MILES DAILY. DURING THIS TIME HE FELT NO PAIN AND THE NUMBNESS OF HIS RIGHT THIGH, WHICH WAS PRESENT PRIOR TO THE OPERATION, IMPROVED DAILY. HE WAS ABLE TO WALK, SIT, DRIVE, ETC. (ALWAYS WEARING HIS PLASTIC BRACE) WITHOUT EXPERIENCING PAIN. DURING THIS TIME, HE DID NOT HAVE ANY MISHAPS OR FALL DOWN. ON 5/21/95 HE WAS NOT ABLE TO PERFORM HIS DAILY 2-MILE WALK BECAUSE OF BACK PAIN IN HIS LOWER LEFT SIDE AND PAIN IN HIS LEFT LEG CALF. SINCE THEN HE HAS BEEN PRACTICALLY BED-RIDDEN BECAUSE OF THE PAIN WHICH DOES NOT ALLOW HIM TO FUNCTION IN A DECENT MANNER. EVEN REACHING FOR A TOWEL, HURTS HIS BACK. ON 6/2/95, X-RAYS REVEALED THAT ONE OF THE 6 PEDICLE SCREWS HAD BROKEN. RECENTLY, HE HAS NOTICED A SLIGHT IMPROVEMENT IN HIS CONDITION, ALTHOUGH, HE STILL NEEDS TO LIE DOWN IN THE BACK SEAT OF THE CAR WHEN HE AND HIS WIFE GO SOMEWHERE. HE CAN TRUTHFULLY SAY THAT HIS CONDITION IS WORSE NOW AS COMPARED TO WHAT IT WAS PRIOR TO SURGERY.
THE NURSE TOLD THE PT TO PRESS THE BUTTON WHEN PAIN RELIEF WAS NEEDED. THE PT ASKED HOW OFTEN THE BUTTON COULD BE PUSHED. BECAUSE THE RESERVOIR UNDER THE BUTTON IS 0.5 CC AND REQUIRES SIX MINUTES TO FILL AFTER BEING EMPTIED, THE NURSE RESPONDED THAT IT COULD BE PRESSED EVERY SIX MINUTES. THE PT'S FAMILY UNDERSTOOD THIS TO MEAN THAT THE BUTTON SHOULD BE PRESSED EVERY SIX MINUTES. THEY PROCEEDED TO DO JUST THAT FOR THE NEXT FOUR HOURS, AT WHICH TIME, THE PT, LONG SINCE UNCONSCIOUS, HAD STOPPED BREATHING. A CODE WAS CALLED; PT WAS RESUSCITATED SUCCESSFULLY. SHE RECEIVED TWO DOSES OF NARCAN. PT WAS A POST-PARTUM PT IN HER EARLY TWENTIES.
A REVISION TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON THE PT DUE TO AN OSTEOLYTIC REACTION. UPON REMOVAL OF THE IMPLANTS, TIBIAL PLATE, TIBIAL ARTICULAR SURFACE AND 4 BONE SCREWS IT WAS NOTED THAT THE TIBIAL PLATE HAD BROKEN, THE REVISION WAS THEN COMPLETED.
ON 2/22/96 A 78-YR-OLD PT ADMITTED TO CCU REQUIRING EXTERNAL PACING FOR CHB ASYSTOLE. PACER PADS ON MA80 RATE 50 WITH GOOD CAPTURE. PT WITH FEW INTRINSIC HEART BEATS. EXTERNAL PACER IN DEMAND MODE. ADMITTED AT 1600. AT 1637 PACER WITH INAPPROPRIATE SENSING/FIRING WITH HR LOW 30'S. PACER RATE 70 MA, 150 REQUIRING MORE THAN 2 MINUTES TO OBTAIN CAPTURE AT RATE 50/MIN. AT 1647 PT WENT INTO VT/VF. NURSE IMMEDIATELY PRESSED CHARGE BUTTON TO CHARGE TO 200 AND MACHINE COMPLETELY TURNED ITSELF OFF. MAIN POWER TURNED BACK ON, CHARGE ATTEMPTED AND UNIT AGAIN POWERED DOWN A TOTAL OF 4 TIMES. CPR WAS PERFORMED WITH TEMPORARY RESUSCITATION OF PT. PT CONTINUED TO HAVE LETHAL BRADYARRHYTHMIAS. ANOTHER EXTERNAL PACER WAS OBTAINED FROM LOCAL EMS AND PLACED ON PT WITH APPROPRIATE SENSING/FIRING/CAPTURING NOTED. PT CONTINUED TO HAVE FREQUENT EPISODES OF LIFE-THREATENING ARRHYTHMIAS. EXTERNAL PACER PLACED BACK ON PT WITH RATE 50 MA 80, RADIAL PULSE 17. PACED BEATS NOT PERFUSING. MA 150 RATE 100. PACER FIRING AT ONLY 70-80 XMIN. MA GRADUALLY WITH GOOD CAPTURE BUT RATE FLUCTUATED FROM 35-UP TO SET RATE BUT NEVER FIRED AT APPROPRIATE RATE. AT THAT POINT ANOTHER INHOUSE EXTERNAL PACEMAKER WAS LOCATED AND PT PLACED ON IT WITH RATE 60, MA 84, GOOD CAPTURE. PT MAINTAINED ON EXTERNAL PACER UNTIL SHE EXPIRED SOME 4 - 4 1/2 HOURS LATER. UNIT AT NO TIME WAS OPERATING ON BATTERY POWER BUT WAS PLUGGED INTO ELECTRICAL OUTLET.
PT SCHEDULED FOR REMOVAL OF SILICONE BREAST IMPLANTS AND REPLACEMENT WITH SALINE IMPLANTS. ON REMOVAL OF RIGHT PROSTHESIS THE IMPLANT WAS FOUND TO BE RUPTURED ON INITIAL INSPECTION. THE LEFT PROSTHESIS WAS INTACT ON REMOVAL BUT WAS RUPTURED BY INSTRUMENTATION. BOTH IMPLANTS WERE PACKAGED AND GIVEN TO SURGEON.
PT WAS TRANSPORTED FROM MEDICAL FLOOR TO CCU. DURING TRANSFER FROM ONE BED TO NEXT, PORTABLE O2 TANK WAS TURNED OVER AND IT LEAKED TO PT'S LOWER EXTREMITIES, CAUSING FROSTBITE. COMPRESSES APPLIED PER EMERGENCY DEPARTMENT PROTOCOL. CONSULT TO PLASTIC SURGERY DONE IMMEDIATELY.
RPTR IS WRITING TO REPORT AN OVERCORRECTED REFRACTIVE SURGICAL PROCEDURE PERFORMED USING AN EXCIMER LASER WHICH TO THE BEST OF RPTR'S KNOWLEDGE IS NOT APPROVED BY THE FDA FOR HUMAN INVESTIGATION. THE PT IS A 33-YR-OLD ESTATE PLANNER WHO CONSULTED THE DOCTOR FOR REFRACTIVE SURGERY. PT STATED THAT HIS REFRACTION IN THE LEFT EYE BEFORE SURGERY WAS APROXIMATELY -8.50 DIOPTERS. HIS REFRACTION IN THE UNOPERATED RIGHT EYE ON 1/18/96 WAS -8.25 +0.25 X105-20/16, MANIFEST REFRACTION. THE PT STATES THAT HE HAD LASER IN-SITU KERATOMILEUSIS SURGERY IN HIS LEFT EYE IN EARLY 12/95. THE PT HAD BEEN A CONTACT LENS WEARER AND STATED THAT HE DID NOT TAKE HIS CONTACT LENS OUT BEFORE REFRACTION AND DID NOT KEEP HIS LENS OUT PRIOR TO SURGERY. HE STATES THAT APPROXIMATELY 24 HOURS AFTER HIS LASER PROCEDURE HIS REFRACTION WAS APPROXIMATELY +6.00 DIOPTERS; APPROXIMATELY TWO WEEKS AFTER SURGERY IT WAS APPROXIMATELY +3.50 DIOPTERS. ON 1/19/96 HE MEASURED A MANIFEST REFRACTION OF +0.50 +1.25 X115-20/25 AND A CYCLOPLEGICAL REFRACTION OF +1.00 +1.25 X115, 20/32. SLIT LAMP EXAMINATION SHOWED A FINE LAMELLAR SCAR WITH DEBRIS IN THE BED. THE FLAP APPEARED ROUGHLY 150 MICRONS THICK AND WAS HINGED NASALLY. THE FLAP DIAMETER WAS 8.0MM. IT WAS 1+ FINE FOLDS IN THE FLAP AND APPROXIMATELY A 2+ SCAR AROUND THE EDGE. THESE FINDINGS ARE INTERPRETED AS NORMAL FINDINGS AFTER THIS PROCEDURE, EXCEPT FOR THE AMOUNT OF DEBRIS IN THE BED. VIDEOKERATOGRAPHY SHOWED A WELL-CENTERED ABLATION WITH CONCENTRIC CIRCULAR RINGS ON THE COLOR-CODED MAP AND A SMALL CENTRAL BOWTIE. THE CENTER WAS EXTREMELY FLAT, WITH A CENTRAL VALUE OF APPROXIMATELY 35 DIOPTERS, CONSISTENT WITH THE HYPEROPIC REFRACTION. PT EXPRESSED TO RPTR CONSIDERABLE DIFFICULTY WITH HIS LEFT EYE, STATING THAT HE HAD GOOD UNDERCORRECTED VISION AT NEITHER DISTANCE NOR NEAR. THE UNCORRECTED VISUAL ACUITY MEASURED FOR DISTANCE USING THE NATIONAL EYE INSTITUTE CHARTS WAS 20/63 IN THE LEFT EYE AND THE UNCORRECTED NEAR VISUAL ACUITY WAS 20/50. PT'S PREOPERATIVE CORRECTED VISUAL ACUITY IN HIS LEFT EYE WAS THE SAME AS THAT PRESENTLY MEASURED IN HIS RIGHT EYE, HE LOST TWO LINES OF MANIFEST SPECTACLE CORRECTED VISUAL ACUITY (20/16 TO 20/25), AND THREE LINES OF CYCLOPLEGIC CORRECTED VISUAL ACUITY (20/16 TO 20/32). PT'S HISTORY IS ACCURATE, THE MARKED OVERCORRECTION THAT OCCURRED IS QUITE UNUSUAL AFTER A LASER IN-SITU KERATOMILEUSIS PROCEDURE. IT IS UNKNOWN WHEN THE RPTR'S REFRACTION WILL STABILIZE, OR AT WHAT LEVEL.
AFTER WEARING GLOVES FOR ABOUT A YEAR ALMOST EVERY DAY, REPORTER STARTED GETTING A RASH ON BOTH HANDS AND FELT A BURNING SENSATION. WHEN SHE TREATS THE RASH WITH A CREAM, IT STOPS BURNING AND THE REACTION EASES VERY QUICKLY.
RPTR HAD SILICONE BREAST IMPLANTS IMPLANTED. SHE C/O CAPSULAR CONTRACTURE, SILICONE LEAKAGE CHRONIC PAIN, CHRONIC FATIGUE "DISEASES." IMPLANTS HAD TO BE "EXPLANTED" 11/27/95.
WHILE FLEXING TUBE PRIOR TO INSERTION, THE TUBE BROKE.
SILICONE BREAST IMPLANT LEAKED SILICONE, CAUSING NUMEROUS SYMPTOMS, CHRONIC INFLAMMATORY DISEASE, IMMUNE DISEASE, NERVE DISEASE & MUSCLE DISEASE. RPTR IS CURRENTLY DISABLED. FORMER INCOME OF 70,000 YEAR. NOTHING NOW. PERMANENT PHYSICAL, & PSYCHOLOGICAL DAMAGE. NEARLY DIED. IMPROPERLY DIAGNOSED BY NUMEROUS DRS. HER WHOLE LIFE CHANGED. IMPLANTS EXPLANTED AND EXCHANGED FOR ANOTHER MFR'S SILICONE IMPLANTS.
RPTR HAD BREAST IMPLANTS PUT IN IN 1980 FOLLOWING MASTECTOMIES FOR FIBROCYSTIC DISEASE. SHE HAS HAD A TOTAL OF 2 BREAST SURGERIES. SHE HAD CALCIUM DEPOSITS. THE RIGHT IMPLANT WAS RUPTURED, SHE HAD AN INFECTION AND NUMBNESS IN THE SURGICAL AREA AND ONE CAPSULAR CONTRACTURE. SHE C/O CHRONIC BLADDER/URINARY INFECTIONS, DEMYELINATING NEUROPATHY, SHORT-TERM MEMORY LOSS, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, CHEST/RIB CAGE PAIN &/OR BURNING SENSATION AND INFLAMMATION, ELEVATED CHOLESTEROL OR TRIGLYCERIDES, CHRONIC SWELLING, PAIN AND HEAT OR COLD SENSITIVITY OF EXTREMITIES, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, HYSTERECTOMY, PREMATURE ATRIAL CONTRACTIONS CAUSING SUPRA VENTRICULAR TACHYCARDIA, UNUSUAL CHRONIC INFECTIONS, JOINTS: INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, PERSISTENT JOINT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY OF NECK, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, VASCULITIS, LONG-TERM EXTREME FATIGUE, CLUMSINESS/DROPS THINGS, MISJUDGES DISTANCE/RUNS INTO OBJECTS, HYPERLIPIDEMIA, BURSITIS, TENDONITIS, FIBROMYALGIA, HEART IRREGULARITY, HYSTERECTOMY, CHRONIC ATROPHIC URETHRITIS, DEMYELINATING POLYNEUROPATHY AND CHRONIC CONSTIPATION. (*)
CATHETER CAME APART AT TUBING/ADAPTER JUNCTION 3 TIMES. PT REINSERTED ADAPTER INTO TUBING EACH TIME. HE DID NOT NOTIFY HOME INFUSION RN OR MD OF CATHETER BREAKAGE UNTIL HE WAS ADMITTED TO HOSP WITH SEPSIS. CATHETER REMOVED AND PT TREATED WITH ANTIBIOTICS; HOWEVER, DIED IN CONGESTIVE FAILURE.
CNA INJURED FOOT UPON RELEASE OF SIDE RAIL WHEN BED IN LOWEST POSITION. (*)
AT END OF OPEN HEART CASE, BLOODY FLUID NOTED IN ICE MACHINE WELL AND LEAKING FROM DRAPE. PT TO BE FOLLOWED BY INFECTION CONTROL DEPT FOR ANY SIGNS OF INFECTION. PT DISCHARGED WITH NO SIGNS OF INFECTION.
LAPAROSCOPIC PROCEDURE IN PROGRESS. WHILE CUTTING TISSUE USING A LASER, A SAPPHIRE SURGICAL LASER TIP SEPARATED. PORTION (APPROX 1 CM) WAS NOT RETRIEVED FROM PT. ATTEMPT TO LOCATE VIA LAPAROSCOPIC EXAM UNSUCCESSFUL.
WHILE PERFORMING AN ENDOMETRIAL ABALATION, USING A RESECTOSCOPE, BAR BROKE OFF IN UTERUS. THE CASE STOPPED AND PIECE RETRIEVED. CASE THEN RESUMED.
PT FOR CHOLECYSTECTOMY. TECHNICAL DIFFICULTY WAS ENCOUNTERED DURING PROCEDURE WITH REGARD TO THE CLIP APPLIER NOT OPERATING PROPERLY. JUST PRIOR TO CLOSING, PT WAS NOTED TO HAVE CONTINUOUS BLEEDING AND CLIPS FOUND "OFF". OPEN CHOLECYSTECTOMY WAS PERFORMED. PT DID WELL WITH NO NEGATIVE OUTCOME. MD FELT PROBLEM WAS THE CLIP APPLIER.
SLING WAS ATTACHED TO LIFT AND RAISED TO TRANSFER RESIDENT. LEG SLING CAME LOOSE AND RESIDENT STARTED TO COME OUT OF SLING.
PT EXPERIENCED CAPSULAR CONTRACTURE, BAKER'S CLASS IV ON LEFT BREAST AND CLASS III ON RIGHT BREAST. DURING SURGERY RIGHT BREAST IMPLANT APPEARED INTACT; LEFT BREAST IMPLANT WAS LEAKING SILICONE WHICH WAS CONTAINED BY THE CAPSULE AROUND THE IMPLANT. A GROSS PATHOLOGICAL EXAMINATION REVEALED A 9.5 CM TEAR IN THE GREATEST DIMENSION ON THE SIDE OF ONE IMPLANT AND A 0.5 CM HOLE IN THE OTHER IMPLANT.
DENTAL IMPLANT FAILED TO ESSEOINTEGRATE.
THERE WERE NO WITNESSES TO THIS ACCIDENT.  BASED ON INVESTIGATION, THE FACILITY CONCLUDED THAT THE RESIDENT CUT HER LOWER LEG ON THE HALF LENGTH SIDE RAIL ON THE BOTTOM PORTION OF RESIDENT'S BED.  THE SIDE RAIL WAS IN THE DOWN POSITION, APPARENTLY, RESIDENT CAUGHT HER LEG ON ROUND, CYCLINDER PORTION OF METAL LATCH.  THE RESIDENT IS CONFUSED AND HAS VERY POOR SKIN INTEGRITY.  INJURY REQUIRED THAT THE RESIDENT BE TRANSFEWRRED TO HOSPITAL EMERGENCY ROOM FOR SUTURES.  WOUND DUE TO RESIDENT'S SKIN CONDITION WAS UNABLE TO BE SUTURED.  RESIDENT AS OF 1/17/96 IS RECEIVING DAILY DRESSINGS AND ANTIBIOTIC TREATMENT.  VASCULAR SURGEON EVALUATEDRESIDENT INJURYON 1/10/96 AND WILLCONTINUE TO BE FOLLOWED AS NECESSARY.  RESIDENT MAY REQUIRE SKIN GRAFT.BASED ON THIS UNSAFE FEATURE, THE SIDE RAILS WERE REMOVED FROM THE RESIDENT'S BED PRIOR TO HER RETURN FROM THE EMERGENCY ROOM.  ALL SIDE RAILS WITH THIS DESIGN WERE REMOVED FROM RESIDENT BEDS ON JANUARY 9, 1996.
CHECK VALVES ON GRAVITY IV TUBING DID NOT FUNCTION. DRUG INJECTED INTO UPPER Y SITE BACKED UP IN TUBING THROUGH CHECK VALVE. NO PT INJURY OR REACTION OCCURRED.
SURGEON WAS DOING A PEG TUBE REPLACEMENT WHEN TUBE WAS SNARED IN ABDOMEN. SNARE BROKE AND DISC OF PEG WAS FREE-FLOATING IN PT'S STOMACH.
BECAUSE OF CHRONIC PAIN FOR YEARS, ON 12/18/95 VIA CERTIFIED LETTER, PT REQUESTED THE DOCTOR REMOVE THE 2ND SET OF HARDWARE. AS OF THIS DATE, HE HAS HAD NO RESPONSE AT ALL. TODAY (3/6/96) HE HAS FINALLY LOCATED A SURGEON WHO WILL REMOVE THIS JUNK. THIS NIGHTMARE SHOULD BE OVER BY THE END OF THIS MONTH. 2ND IMPLANT DATE GIVEN 4/1/93.
ELASTOMERIC DEVICE BURST WHILE STILL IN THE PHARMACY LAB. WHILE FILLING THE PUMP WITH CHEMOTHERAPY, LEADING TO AN EXPOSURE TO CHEMOTHERAPY VESICANT DRUGS VINCRISTINE DOXORUBICIN.
RPTR HAS SOME 3CC SYRINGES WITH 22 GA USE NEEDLES PREPACKAGED INDIVIDUALLY. THE PLUNGERS INSIDE THE BARREL OF THE SYRINGES ARE NOT HORIZONTAL, BUT WAVY. THEY DO NOT GIVE ACCURATE READINGS.
DUE TO FURTHER INVESTIGATION THE FINAL RESULTS FROM THE ORIGINAL ANALYSIS HAVE BEEN AMENDED. THE ACTUAL SAMPLE WAS NOT RETAINED FOR ANALYSIS. CUSTOMER RETURNED 41 UNUSED SAMPLES. ALL SAMPLES RETURNED WERE VISUALLY INSPECTED AND WERE LUER SLIP TESTED FOR DEFECT. IT WAS CONFIRMED THAT FIVE OF THE ADAPTERS RETURNED HAD BEEN DAMAGED ON THE OUTSIDE OF THE UNITS, DURING THE MFG PROCESS. LOT HISTORY REVIEW SHOW FINDINGS OF DAMAGED ADAPTERS AND CORRECTIVE ACTIONS TAKEN. THESE HISTORIES DETERMINE THE CAUSE FOR THE REPORT OF ADAPTER/HUB IMPERFECTION AS REPORTED ON THIS MEDWATCH REPORT. THIS WAS NOT REPORTED AS A MDR.
SHEATH BROKE OFF INSIDE THE PT APPROXIMATELY 3 TO 4" FROM PROXIMAL TIP. ATTEMPTS TO USE A SNARE TO RETRIEVE THE BROKEN PIECE CAUSED A SMALL (1/2") PIECE TO BREAK OFF AND GO TO THE LEFT LUNG. SUBSEQUENT FLUOROSCOPY SHOWED A LARGER PROXIMAL PIECE BROKE OFF AND WENT INTO THE RIGHT LUNG POSSIBLY JUST FROM THE HEART MOVEMENT. LARGER PIECE WAS REMOVED IN THORACOTOMY IN SURGERY. EPILEPSY HISTORY. PT FOUND APPROXIMATELY TWO WEEKS AGO AT SCHOOL IN V-FIB. SHOCKED SEVERAL TIMES TO GET NORMAL SINUS RHYTHM. STABILIZED BUT HAS NOT REGAINED CONSCIOUSNESS.
EVACUATOR SEEMS TO HAVE LEAKED; HAD TO USE ANOTHER. THIS HAPPENED 2 TIMES WITH 2 DIFFERENT PTS.
DEVICE USED TO DELIVER FENTANYL VIA EPIDURAL ROUTE IN HOSPITAL. DEVICE INDICATED THAT DRUG WAS BEING INFUSED FOR PAST 24 HOURS YET NO DRUG WAS DELIVERED TO PT DURING THAT TIME. TUBING HAD CRIMP (FROM CLAMP) THAT PREVENTED THE PROPER FLOW OF DRUG. DEVICE DID NOT HAVE ALARM OR INDICATOR THAT ALERTED STAFF WHEN FLOW WAS INTERRUPTED. PT EXPERIENCED SEVERE UNNECESSARY PAIN FOR 24 HOURS AS RESULT OF THIS DEVICE PROBLEM. IT SHOULD BE ESSENTIAL FOR DEVICE OF THIS TYPE TO HAVE A "NO FLOW" INDICATOR OR ALARM.
UNIT WAS BEING USED TO TREAT A SKIN CANCER. THE UNIT INDICATED THAT X-RAYS WERE BEING ADMINISTERED, WHEN, IN FACT, NO IRRADIATION WAS GIVEN FOR THE LAST HALF OF THE TREATMENT. THIS WAS DUPLICATED ON A TRIAL RUN, AND CONFIRMED BY THE PHYSICIST.
PATIENT'S CAREGIVER PROCEEDED TO GIVE MEDICATION. CAREGIVER THEN NOTICED MEDICATION LEAKING OUT OF PUMP. CAREGIVER CALLED SO RPTR COULD SEND OUT ANOTHER PUMP.
CAREGIVER PROCEEDED TO INFUSE MEDICATION, BUT PUMP WOULD ONLY ALARM "MALFUNCTION." PHARMACIST CHANGED PATIENT TO A DIFFERENT TYPE OF PUMP.
THE GASTROSTOMY TUBE PORT ON THE JEJUNAL TUBE CRACKED IN HALF AND FELL OFF. PT WAS UNABLE TO GET HER MEDICATION OR STOP STOMACH CONTENTS FROM LEAKING OUT.
GERI-CHAIR'S BRAKE DID NOT ENGAGE. PT SLIPPED TO FLOOR.
MESH ADHERED TO BOWEL. PT REQUIRED READMISSION AND REEXPLORATION. PT HAD BOWEL OBSTRUCTION.
AUTOMATIC BLOOD PRESSURE CUFF DID NOT STOP INFLATING WHEN IT REACHED ITS UPPER LIMIT. PT NOTED TO HAVE RIGHT ARM PETECHIAE AND REDNESS.
CUSTOMER INITIALLY REPORTED TWO AIRWAY TUBE BREAKS ON 1/23/96. ONE OF THE BREAKS OCCURRED IN 11/95 WHILE BEING USED IN A PT. THE SECOND REPORTED TUBE BREAKAGE OCCURRED DURING THE PRE-USE "BEND TEST" PROCEDURE, WHICH IS DESCRIBED IN THE INSTRUCTION MANUAL, AND NO PT CONTACT OCCURRED. THE NURSE ANESTHETIST STATED ON 2/6/96, THAT THE MASK USED IN THE PT HAD DISCOLORED TUBING; A "KINK" TEST WAS NOT PERFORMED PRIOR TO INSERTION. AFTER INSERTING MASK IN PT AND CONNECTING TO CIRCUIT, A GURGLING SOUND WAS HEARD AND THE AIRWAY TUBING SEPARATED FROM THE CUFF. THE MASK WAS THEN DEFLATED AND, WITH SOME DIFFICULTY, PRIED FROM THE PT'S THROAT USING HER FINGERS. THE NURSE ANESTHETIST NOTICED SOME BLOOD IN THE PT'S MOUTH WHICH WAS THE RESULT OF SCRAPING THE PALATE. THE PT WAS THEN SUCTIONED AND INTUBATED WITHOUT DIFFICULTY. THE PT HAD NO REPORTED COMPLAINTS AND DID WELL.
MEDICAL RESIDENT (WHO WAS NOT SUPPOSED TO BE THERE) IN THE MICU WAS LEARNING HOW TO PLACE A FEMORAL HEMODIALYSIS CATHETER. HE LOST THE GUIDE WIRE IN THE PT'S BLOODSTREAM AND THE PT WAS TAKEN TO THE OR TO HAVE IT REMOVED. RESIDENT WAS NOT TRAINED IN THIS PROCEDURE, NOT A PRODUCT FAILURE.
FOLEY CATHETER PLACED IN BLADDER. NNP INFLATED BALLOON WITH 5CC NS. POP WAS HEARD WITH BRIGHT RED BLOOD RETURN. ATTEMPTED TO WITHDRAW NS FROM BALLOON AND RETURN WAS BLOOD TINGED. CATHETER REMOVED; BALLOON HAD POPPED. THERE SHOULD HAVE BEEN ONLY 1.5ML INSTILLED. ON THE LABEL THE PERIOD LOOKED LIKE A COMMA SO THE INDIVIDUAL TOOK IT TO BE 1,5ML RATHER THAN 1.5ML.
THE LUER LOCK FELL OFF OF THE NEEDLE TUBING.
INSERT SHOWED WEAR. IT WAS REPLACED WITH 13MM LARGE PRIMARY REVISION INSERT. PATELLA WAS LOOSE. PATELLECTOMY WAS PERFORMED.
POLY DISASSOCIATED FROM METAL. REQUIRED REMOVAL AND NEW PATELLA IMPLANTED.
DURING A UTETEROSCOPY STONE REMOVAL PROCEDURE, ONE JAW OF THE FORCEPS BROKE OFF AND WAS NOT RETRIEVED.
STAPLE GUN WAS USED AND WORKED. FIRST RELOAD WAS USED AND WORKED. SECOND RELOAD APPEARED TO WORK BUT LATER, WHEN DOING VAGINAL WORK, IT WAS REALIZED THAT THE RELOAD STAPLED BUT DID NOT CUT. THIRD RELOAD WOULD NOT FIRE THE STAPLES.
TPA HUNG ON PUMP. MACHINE NOTED SEVERAL TIMES TO BE PROGRESSING AS USUAL FROM PROGRAM I-III. SPOT CHECK ON VOLUME REMAINING IN BOTTLE AND NOTED THAT TUBING WAS CLAMPED. NO VOLUME INFUSED. NO ALARMS INDICATING NO FLOW.
ON 11/16/95 WHEN RPTR'S HYGIENIST WAS SEATING HER PT THE CHAIR CAME DOWN ON HER FOOT. SHE WAS TRAPPED IN THIS POSITION, DUE TO NO OVERRIDE, FOR 18 MINUTES, RESULTING IN A BROKEN FOOT. RPTR CONTACTED 911 TO HAVE EMS UNIT HELP EXTRICATE THE FOOT. HER HYGIENIST MISSED WORK FOR ALMOST 3 MONTHS BECAUSE OF THIS EVENT. IT IS RPTR'S CONTENTION THAT THE CHAIR IS UNSAFE BECAUSE THE BASE COMES TOO CLOSE TO THE FLOOR. THERE IS A FOOT CONTROL PEDAL THAT, IF IT ENDS UP DIRECTLY BENEATH THE BASE, CAN TRAP THE FOOT. ONCE TRAPPED IN "DOWN" POSITION THERE IS NO MECHANISM BY WHICH TO BYPASS THIS. ON MONDAY, 11/27/95, A MFR'S REP CAME TO RPTR'S OFFICE TO TEST THE CHAIR. HE AGREED THAT THERE WAS A PROBLEM WITH THE CHAIR AND IT WAS A MATTER THAT NEEDED TO BE EXAMINED FURTHER. HE WAS TOLD THE MFR WOULD CONTACT HIM. THEY NEVER DID.
CATHETER PLACED LEFT ARM ON 1/11/96. PT CALLED ON 1/15/96 TO REPORT SHE HAD BEEN HOSPITALIZED WITH CELLULITIS AND BLOOD CLOT. PT STATES SYMPTOMS BEGAN 1/13/96 WITH SORENESS OF LEFT ARM. SHE STATES THE HOME CARE AGENCY WAS NOTIFIED 1/14 OF SYMPTOMS AND THAT PT HAD REMOVED CATHETER HERSELF.
DEVICE WAS INSERTED WITHOUT DIFFICULTY IN PT'S LEFT ANTECUBITAL FOSSA, CEPHALIC VEIN. AFTER AN UNSUCCESSFUL ATTEMPT AT THREADING DEVICE BEYOND 1 1/2", RPTR REMOVED DEVICE AND HELD PRESSURE WITHOUT STERILE GAUZE FOR APPROX 2 MINS. THE PT BEGAN TO C/O DYSPNEA, STATING "SHE COULD NOT GET HER BREATH." THE PT SUBSEQUENTLY BECAME UNRESPONSIVE WITH THREADY PULSE, CLAMMY SKIN, BP 64/44. NO EKG CHANGES NOTED. THE PT BECAME AROUSABLE APPROX 1-2 MIN AFTER PERIOD OF HYPOTENSION AND BP RETURNED TO NORMAL LIMITS. NO FURTHER ATTEMPTS AT MIDLINE PLACEMENT MADE. A STANDARD PERIPHERAL IV 20 1 1/4" WAS PLACED.
EXPLANT OF PERMANENT PACEMAKER. INSERTION DUAL CHAMBER PACEMAKER.
RPTR FILLED ELASTOMERIC DEVICE WITH IV ANTIBIOTIC SOLUTION. SHE ATTEMPTED TO PRIME THE PUMP'S TUBING. THE SOLUTION COULD NOT FLOW PAST AIR FILTER IN TUBING AND THE TUBING COULD NOT BE PRIMED. NO SOLUTION WOULD DRIP OUT OF THE TUBING WHICH MEANT NO ANTIBIOTIC DOSE COULD BE ADMINISTERED FROM THE PUMP.
RPTR HAS A BRONCHIAL ALLERGY CAUSING A SEVERE COUGH ONCE A YEAR. NOW THAT SHE IS OLDER, COUGHING MAKES HER INCONTINENT. AS A RESULT SHE USES TWO INCONTINENCE PADS PER DAY WHILE COUGHING. SHE HAS NEVER HAD PROBLEMS USING THEM UNTIL THIS FALL. THE TYPE NOW ON SALE HAVE A BLUE INNER LAYER AND LOTS OF NEW AND IMPROVED ADVERTISING ON THE OUTSIDE. AFTER 9 DAYS OF USING THIS BRAND OF PAD, SHE HAD UNCOMFORTABLE DRYNESS, LIGHTHEADEDNESS AND DIFFICULTY STANDING IN THE MORNING. THREE DAYS OF ANOTHER MFR'S PAD WAS NOT MUCH OF AN IMPROVEMENT ALTHOUGH THE WETNESS CONTROL WAS DESCRIBED AS LIGHT. BOTH MFRS LISTED PHONE NUMBERS AND RESPONDED WITH COURTESY AND INCREDULITY. THE 2ND CO RETURNED HER MONEY AND THE FIRST GAVE HER COUPONS FOR OTHER TYPES OF THEIR PRODUCTS. THEY ALSO MADE IT POSSIBLE TO SEND THEM A SAMPLE OF HER PURCHASE. SHE HOPES THERE WILL BE FURTHER INVESTIGATION OF THIS PRODUCT BECAUSE MANY WHO MUST USE IT ARE HELPLESS AND CANNOT PROTECT THEMSELVES. DELAY OF REPORT DUE TO FAMILY ILLNESS. (ALSO SEE 1008611)
RPTR HAS A BRONCHIAL ALLERGY CAUSING A SEVERE COUGH ONCE A YEAR. NOW THAT SHE IS OLDER, COUGHING MAKES HER INCONTINENT. AS A RESULT SHE USES TWO INCONTINENCE PADS PER DAY WHILE COUGHING. SHE HAS NEVER HAD PROBLEMS USING THEM UNTIL THIS FALL. THE TYPE NOW ON SALE HAVE A BLUE INNER LAYER AND LOTS OF NEW AND IMPROVED ADVERTISING ON THE OUTSIDE. AFTER 9 DAYS OF USING THIS BRAND OF PAD, SHE HAD UNCOMFORTABLE DRYNESS, LIGHTHEADEDNESS AND DIFFICULTY STANDING IN THE MORNING. THREE DAYS OF ANOTHER MFR'S PAD WAS NOT MUCH OF AN IMPROVEMENT ALTHOUGH THE WETNESS CONTROL WAS DESCRIBED AS LIGHT. BOTH MFRS LISTED PHONE NUMBERS AND RESPONDED WITH COURTESY AND INCREDULITY. THE 2ND CO RETURNED HER MONEY AND THE FIRST GAVE HER COUPONS FOR OTHER TYPES OF THEIR PRODUCTS. THEY ALSO MADE IT POSSIBLE TO SEND THEM A SAMPLE OF HER PURCHASE. SHE HOPES THERE WILL BE FURTHER INVESTIGATION OF THIS PRODUCT BECAUSE MANY WHO MUST USE IT ARE HELPLESS AND CANNOT PROTECT THEMSELVES. DELAY OF REPORT DUE TO FAMILY ILLNESS. (ALSO SEE 1008610)
AFTER TPN INFUSES FOR A FEW HOURS, THE FILTER CLOGS AND THE PUMP ALARMS. WHEN THE FILTER IS REMOVED, TPN RUNS WITH NO OCCLUSION.
RPTR C/O SEVERE CAPSULAR CONTRACTURE, LOSS OF FEELING, CAUSING A "BAD EFFECT," REQUIRING EXPLANTATION (HOSPITALIZATION) TO CORRECT CAPSULAR CONTRACTURE DEFORMITY. EXPOSURE TO SILICONE MATERIALS EVENTUALLY CAUSED ATYPICAL NEUROLOGICAL DISEASE WITH MS-LIKE SYNDROME AND BREAST ADJUVANT DISEASE.
RPTR C/O PARTIAL LOSS OF VISION (SCATOMA) LATE 70'S, CAPSULAR CONTRACTURE, BILATERAL BREAST IMPLANT RUPTURE, SILICONOMA FORMATION, NIGHT SWEATS, OPTIC NERVE DISEASE, COLD BREASTS, RASHES, PHOTO SENSITIVITY, MS-LIKE SYMPTOMS, MUCOSAL ULCERS, CAPSULAR CONTRACTURE REQUIRED EXPLANTATION. TWO PREGNANCIES DURING THIS TIME AND NOW TWO AFFECTED CHILDREN WHOSE LAB TESTS ARE ABNORMAL AS WELL.
RPTR'S DAUGHTER WAS EXPOSED TO HER GROSSLY RUPTURED SILICONE GEL BREAST IMPLANTS FROM THE MOMENT OF CONCEPTION. (SHE WAS EXPOSED IN UTERO). SHE NOW HAS PAINFUL JOINTS, HEADACHES, ESOPHAGITIS, MILD DYSMOBILITY, HEARTBURN, JOINTS CLICK WHEN SHE WALKS, CONCEPTUAL PROBLEMS AND STOMACH ACHES. SHE REQUIRES MEDICATION.
RPTR'S SON WAS EXPOSED TO HER GROSSLY RUPTURED SILICONE GEL BREAST IMPLANTS FROM THE MOMENT OF CONCEPTION. (HE WAS EXPOSED IN UTERO). HE NOW HAS SWOLLEN JOINTS, HEADACHES, RASHES, STIFFNESS, REFLUX, ALLERGIES, ASTHMA. HE WAS BORN 1 MONTH PREMATURE. HE REQUIRES MEDICATION.
RPTR C/O GROSS RUPTURE, DISAPPEARANCE OF POLYURETHANE FOAM (BOTH IMPLANTS), LATERAL DISPLACEMENT, SPILLAGE OF SILICONE INTO TISSUE. SHE HAS BEEN DIAGNOSED WITH BREAST ADJUVANT DISEASE AND ATYPICAL NEUROLOGICAL DISEASE WITH MS-LIKE SYNDROME.
RPTR C/O CAPSULAR CONTRACTURE; BREAST DISFIGUREMENT; LOSS OF FEELING (NUMBNESS); BURNING AND TINGLING OF LEGS, FEET ARMS AND HANDS; BALANCE PROBLEMS; JOINT PAIN; HEARTBURN; MUSCLE WEAKNESS; VULVA SCLEROSIS, ANKLE SWELLING, (JUST TO NAME A FEW) AND LYMPHADENOPATHY.
TWO PTS IN ANOTHER HOSP INHALED AND ASPIRATED NASOPHARYNGEAL AIRWAYS. APPARENTLY THE PHLANGE ON THE END IS SO SOFT AND THIN, THE PT CAN INHALE AND SUCK IT IN. RPTR HAS PULLED ALL THESE FROM USE IN HER HOSP.
PT UNDERGOING CORONARY ANGIOPLASTY WITH STENT PLACEMENT IN THE LEFT ANTERIOR DESCENDING ARTERY. STENT INTRODUCED IN THE LESION AREA. BALLOON ON STENT CATHETER INFLATED PER RECOMMENDED PARAMETERS. BALLOON WOULD NOT DEFLATE. BLOOD FLOW COMPROMISED FOR APPROX 3 MIN. PT CODE ARRESTED. PT TO OR FOR CABG.
PT PREPARED AND READY FOR YAG LASER TREATMENT. LASER PRE-TESTED ON STANDBY MODE WITH TEST FIRE SET AT 3.1 MILLIJOULES AND FOUR PULSES PER APPLICATION. PT AND LENS SET IN PLACE FOR TREATMENT. LASER FIRED, POWER RELEASED READ 4.1 ON SCREEN (WHICH WAS BLINKING). PT WAS STARTLED AND JUMPED BACK. HOSP BIOMEDICAL SUPERVISOR NOTIFIED. CO NOTIFIED. EQUIPMENT REMOVED FROM SERVICE.
DEVICE BEING USED TO EXCISE UTERINE TISSUE. WHEN LASER FIBER WITHDRAWN FROM ABDOMEN VIA SUCTION PORT WITH SCALPEL ATTACHED, IT WAS PLACED ON THE ABDOMEN. ON REPLACING THE FIBER DOWN THE SUCTION PORT THE SCALPEL WAS NOT VISIBLE. THE SURGEON USED THE LAPAROSCOPY CAMERA TO SEARCH THE ABDOMINAL AREA BUT THE PROBE WAS NOT FOUND. IT IS BELIEVED THAT THE SCALPEL MAY HAVE BECOME LOOSE AND FALLEN OFF THE LASER FIBER POSSIBLY BECAUSE IT HAD NOT BEEN TIGHTENED SUFFICIENTLY.
IMPLANTED VASCULAR ACCESS TUBING FRACTURED AT SIGHT WHERE CATHETER PASSED UNDER THE FIRST RIB.
DEVICE LEAKING BELOW THE MALE ADAPTER AT THE INJECTION PORT. DEVICE HAD BEEN IN USE LESS THAN 48 HOURS.
VENTILATOR BECAME INOPERABLE WHILE IN USE. VENTILATOR INOPERABLE SIGNAL ACTIVATED. ALL OTHER DISPLAYS OFF. INTERVENTION REQUIRED TO VENTILATE PT.
ON 1/26/96 BILATERAL 150CC SILICONE BREAST IMPLANTS REMOVED. RIGHT IMPLANT RUPTURED AND LEAKING SILICONE MATERIAL. LEFT IMPLANT APPEARS INTACT. BREAST IMPLANTS REPLACED WITH SALINE IMPLANTS, MASTOPEXIES AND CAPSULOTOMIES.
INFORMED ON 2/7/96 OF EVENT. TROCAR FAILED TO RETRACT DURING LAPAROSCOPIC APPENDECTOMY AND CAUSED LACERATION OF ARTERY, 1000 EBL. PT DID RECOVER WITH SLIGHT EXTENDED LENGTH OF STAY. HAD TO PERFORM EXPLORATORY LAPAROTOMY AFTER PERFORATION.
VENTILATOR INOPERATIVE ALARM CAME ON WHILE ON PT. PT REMOVED FROM VENTILATOR AND MANUALLY VENTILATED. NO HARM CAME TO PT DUE TO PROMPT USER ATTENTION.
FRACTURED CATHETER REQUIRING TWO INVASIVE PROCEDURES FOR REMOVAL: FLUORO-RETRIEVAL OF INTRAVASCULAR FOREIGN BODY VIA RIGHT FEMORAL VEIN ON 2/2/96; EXCISION OF RESERVOIR OF CENTRAL CATHETER TO BE DONE IN TWO WEEKS. THE CENTRAL CATHETER COULD NOT BE ACCESSED TWO-AND-A-HALF WEEKS FOLLOWING INSERTION SO A RADIOLOGICAL EXAMINATION WAS DONE. THE STUDY REVEALED THAT THE CATHETER HAD FRACTURED SINCE LAST EXAMINATION AND WAS NOW INTRACARDIAC. A LARGE FRAGMENT WAS NOTED IN THE SUPERIOR VENA CAVA, EXTENDING INTO THE RIGHT ATRIUM. THE CENTRAL VENOUS CATHETER FRAGMENT (13CM) WAS SUCCESSFULLY RETRIEVED. THE PT TOLERATED THE PROCEDURE WELL.
BOTH LINES OF CATHETER BROKE OFF, REQUIRING SURGICAL REMOVAL.
DURING LAPAROSCOPY, NURSE PLUGGED BIPOLAR FORCEPS INTO HAND-SWITCH MONOPOLAR JACK INSTEAD OF MICROPOLAR JACK. ESU WAS ACTIVATED AS SOON AS JAWS OF FORCEPS WERE CLOSED DURING INSERTION THROUGH LAPAROSCOPY SHEATH, CAUSING POSSIBLE BOWEL BURN. CONVERTED TO LAPAROTOMY TO EXAMINE FOR INTERNAL BURN. NO SIGNIFICANT INJURY. NOTE: PT HAD LENGHTENED HOSPITALIZATION. THIS PROBLEM CAN OCCUR WITH MANY DIFFERENT BIPOLAR CORDS AND ELECTROSURGICAL UNITS. BECAUSE OF DESIGN OF CORDS AND UNITS, IT IS POSSIBLE TO PLUG BIPOLAR CORDS INTO MONOPOLAR HAND-SWITCH JACKS. (*)
HEMODIALYSIS TREATMENT WAS INITIATED WITHOUT PROBLEMS. "BLOOD LEAK" ALARM (BLOOD IN DIALYSATE) SOUNDED AFTER PT HAD RECEIVED 1 1/2 HOURS OF DIALYSIS. OUTGOING DIALYSATE TEST POSITIVE FOR BLOOD TWO TIMES, ALTHOUGH NO VISIBLE BLOOD TINGE WAS NOTED IN OUTGOING DIALYSATE. DIALYSIS WAS TERMINATED WITHOUT RETURNING THE BLOOD IN THE EXSTRACORPORAL CIRCUIT. DIALYSIS WAS REINITIATED WITH NEW HEMODIALYZER AND TUBING. NO APPARENT ADVERSE PT REACTION TO EVENT.
HEMODIALYSIS TREATMENT WAS INITIATED WITHOUT PROBLEMS. "BLOOD LEAK" ALARM (BLOOD IN DIALYSATE) SOUNDED AFTER PT HAD RECEIVED APPROXIMATELY ONE HOUR OF DIALYSIS. OUTGOING DIALYSATE TESTED POSITIVE FOR BLOOD TWO TIMES AND BY VISUAL OBSERVATION OF PIN TINGED DIALYSATE. DIALYSIS TREATMENT WAS TERMINATED WITHOUT RETURNING THE BLOOD IN THE EXTRACORPOREAL CIRCUIT. DIALYSIS WAS REINITIATED WITH NEW HEMODIALYZER AND TUBING. NO APPARENT ADVERSE PT REACTION TO EVENT.
PT ARRIVED IN STABLE CONDITION FOR HEMODIALYSIS TREATMENT. DIALYSIS WAS INITIATED AND IMMEDIATE "BLOOD LEAK" ALARM (BLOOD IN DIALYSATE) OCCURRED. OUTGOING DIALYSATE TESTED POSITIVE FOR BLOOD TWO TIMES AND BY VISUAL OBSERVANCE OF PIN-TINGED DIALYSATE. DIALYSIS WAS TERMINATED WITHOUT RETURNING BLOOD IN THE EXTRACORPOREAL CIRCUIT. DIALYSIS WAS REINITIATED WITH NEW HEMODIALYZER AND TUBING. NO APPARENT ADVERSE PT REACTION TO EVENT.
HEMODIALYZER WAS REPROCESSED USING REPROCESSING SYSTEM (5 REUSES). WHEN PREPARING TO USE THE HEMODIALYZER FOR THE PT. THE CAREGIVER NOTED THAT A SMALL AMOUNT OF THE HEMODIALYZER POTTING MATERIAL HAD APPARENTLY EXTRUDED INTO THE DIALYSATE PORT AT THE VENOUS END (BLUE COLOR-CODED) OF THE DIALYZER. THIS HEMODIALYZER WAS REJECTED FOR USE AND SAVED FOR FOLLOW-UP ON A POTENTIAL PRODUCT PROBLEM.
LEAKING BREAST IMPLANT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  OTHER.  CONCLUSION:  OTHER.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ON 12/9/95 PT ADMITTED FOR MULTIPLE ICD SHOCKS WHICH WAS FOUND TO BE RELATED TO A LEAD FRACTURE IN THE DEFIBRILLATION LEAD. ON 12/11/95 PT UNDERWENT SURGERY FOR A PACING LEAD REVISION.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  DEVICE FAILED DURING ASSEMBLY, DEVICE FAILED JUST PRIOR TO USE.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE DISCARDED.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHILE USING THE MASSAGER, WITHIN A FEW SECONDS RPTR HEARD A POPPING NOISE AND BEFORE THERE WAS TIME TO REACT, RPTR'S HAIR WAS PULLED FROM HER HEAD TO THE ROOTS IN AN AREA APPROX 1 1/4 TO 1 1/2 INCHES LONG AND 1/2 INCH WIDE. IT WAS A BALD SPOT THAT BECAME VERY SORE AND SWOLLEN. THE WHOLE INCIDENT HAPPENED IN THE SPACE OF ABOUT 5 SECONDS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A MEDICAL TECHNOLOGIST IN THE COAGULATION LABORATORY WAS COMPARING LOT 953124 WITH ANOTHER PREVIOUSLY USED LOT 953076 OF THE SAME KIT BY RUNNING BOTH LOTS IN PARELLEL TO TEST A PLASMA THAT HAD BEEN CONFIRMED TO BE DEFICIENT IN PROTEIN S ACTIVITY. THE TEST PLASMA HAD AN EXPECTED LEVEL OF 38% ACTIVITY; HOWEVER LOT 953124 OBTAINED 54%, WHEREAS THE LOT 953076 YIELDED 43%, THE LATTER BEING MUCH CLOSER TO THE TARGET VALUE (38%). THIS OVERESTIMATION BY LOT 953124 WAS NOT NEGLIBIBLE, AND WAS CONSIDERED TO BE DUE TO THE TEST PLASMA BEING FROM A HETEROZYGOUS PT. IN THE UNITED STATES THE DISTRIBUTOR HAS NOT RECEIVED ANY REPORT OF THIS NATURE ABOUT LOT 953124 AS OF THIS DATE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  A DEVICE FROM SAME LOT WAS EVALUATED.  RESULTS OF EVALUATION:  UNANTICIPATED.  CONCLUSION:  DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR.  THE DEVICE WAS DESTROYED/DISPOSED OF.
BIFURCATED 16X9 GRAFT IMPLANTED. WHEN CLAMPS RELEASED, BLOOD LEAKED THROUGH GRAFT WALL.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
INSERT WOULD NOT LOCK ONTO BASEPLATE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
REVISION SURGERY CONFIRMED WEAR OF 7MM INSERT WHICH WAS REPLACED WITH 9MM INSERT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING FIELD EVALUATION THE SYRINGE FRACTURED AND RESULTED IN THE OUTER BARREL AND SPRING BEING SHOT ACROSS THE ROOM AFTER BEING USED FOR AN INFANT'S INJECTION. THE SYRINGE WAS POINTED AWAY FROM THE CHILD AND DID NOT HARM HIM.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ON 1/2/96 AT APPROX 6:15 AM, RESIDENT'S NURSING ASSISTANT LOCKED INTO POSITION RIGHT SIDE RAIL. WHILE PROCEEDING TO LEFT SIDE OF BED, RIGHT SIDE RAIL FELL ALLOWING PT TO FALL TO THE FLOOR. RESIDENT SUSTAINED RIGHT HIP FRACTURE. RESIDENT SENT TO HOSP FOR ER SERVICES AND EVALUATION. RESIDENT RE-ADMITTED TO NURSING HOME ON SAME DAY (1/2/96).DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  MECHANICAL PROBLEM.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE TEMPORARILY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIRTY-FIVE-YEAR OLD FEMALE. SURGICAL DRAINAGE DEVICE BROKE DURING ATTEMPTED REMOVAL BY SURGEON. PART OF THE DEVICE REMAINED INSIDE THE PT REQUIRING SURGICAL REMOVAL.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SIXTY-SEVEN-YEAR OLD FEMALE. REQUIRED REPLACEMENT OF AN INTRA-AORTIC BALLOON TO CONTINUE CARDIAC ASSISTANCE IN A LIFE-THREATENING SITUATION. INTRA-AORTIC BALLOON DEVELOPED A LEAK. THE BALLOON WAS REPLACED BY THE SURGEON. THE PT WAS NOT INJURIED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A BATH BENCH COLLAPSED ON RPTR'S MOTHER CAUSING PHYSICAL INJURIES THAT NEEDED MEDICAL ATTENTION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A MEDICAL TECHNOLOGIST IN THE COAGULATION LAB WAS COMPARING A LOT # (JUST RECEIVED) WITH ANOTHER PREVIOUSLY USED LOT OF THE SAME PROTEIN S KIT, BY RUNNING BOTH LOTS IN PARALLEL TO TEST A PLASMA THAT HAD BEEN CONFIRMED TO BE DEFICIENT IN PROTEIN S ACTIVITY. THE TEST PLASMA HAD AN EXPECTED LEVEL OF 38% ACTIVITY; HOWEVER 2ND LOT OBTAINED 54%, WHEREAS THE 1ST LOT YIELDED 43%, THE LATTER BEING MUCH CLOSER TO THE TARGET VALUE (38%). THIS OVERESTIMATION BY 2ND LOT WAS NOT NEGLIGIBLE, AND WAS CONSIDERED TO BE DUE TO THE TEST PLASMA BEING FROM A HETEROZYGOUS PT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  A DEVICE FROM SAME LOT WAS EVALUATED.  RESULTS OF EVALUATION:  UNANTICIPATED.  CONCLUSION:  DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR.  THE DEVICE WAS DESTROYED/DISPOSED OF.
THE PT EXPERIENCED PAIN IN THE RIGHT KNEE. IT WAS DETERMINED THAT THE IMPLANTS WERE LOOSE AND A REVISION WAS NECESSARY. A DIFFERENT TYPE FEMORAL COMPONENT WAS IMPLANTED WITH A BASEPLATE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT BEGAN TO EXPERIENCE PAIN AND SWELLING IN THE LEFT KNEE. IT WAS DETERMINED THAT A SURGERY WAS NEEDED TO ASSESS WHAT WAS CAUSING THE PAIN. IT WAS DETERMINED INTEROPERATIVELY THAT THE PT NEEDED A NEW POLYETHYLENE INSERT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DIALYZERS FROM THIS LOT NUMBER AND ISSUED TO PTS, ALL PRESENTED LOWER THAN USUAL ORIGINAL VOLUMES AFTER PRE-PROCESSING. THE ORIGINAL VOLUME IS ON AN AVERAGE 140. NOTE RESULTS OF ORIGINAL AND USE VOLUMES AS ENCLOSED ON FIVE PATIENTS USING THE KIDNEY. DURING THE USE OF THE DIALYZERS, EACH KIDNEY HAD CLOTTED FROM BLOODPORT TO BLOODPORT, JUST RIGTH OF THE LABEL, AND IN A HALF TO ONE INCH STRIP. THIS CAUSED DRAMATIC DROPS IN VOLUME AND AN INCREASE IN VOLUME FAILURES. HISTORICALLY, THER PTS HAVE NOT BEEN CHRONIC REUSE PROBLEMS. WHEN CHECKED, THE HEMATOCRITS FROM THESE PTS WERE NORMAL OR BETTER THAN USUAL. THE NURSING STAFF, HAS ALSO VERIFIED THAT NO CHANGE IN HEPARIN DOSAGE OCCURRED DURING THIS TIME FRAME.        THE PROBLEM OCCURRED ON NO OTHER TYPE DIALYZER. THE CO'S MEDICAL SUPPLIER WAS NOTIFIED OF THE PROBLEM ON 2/14/96. THE STAFF WAS INSTRUCTED TO PULL THE LOT NUMBER FROM INVENTORY AND RETURN IT TO THE SUPPLIER.
PT ON CONTINUOUS MECHANICAL VENTILATION. THE VENTILATOR "JUMPED" CALIBRATION WHILE ON PT. PRESSURE AND VOLUME DELIVERY DROPPED BY APPROXIMATELY 20%. RECOGNIZED QUICKLY, PT BAGGED, EXPERIENCED MILD DESATURATION AND RECOVERED QUICKLY. CO CALLED, REPRESENTATIVE CHECKED MACHINE, FOUND PRESSURE TRANSDUCER WITH INTERMITTENT CONTACT PROBLEM. CONTACTS CLEANED/REPAIRED, MACHINE CHECKED OUT X 72 HOURS AND IS NOW FUNCTIONING PROPERLY. RETURNED TO SERVICE.
WHILE PT WAS RECEIVING TREATMENT FROM A STIMULATOR, THE UNIT SENT STRONG AMOUNTS OF MILLIAMPS. THE OUTPUT BUTTON WAS NEVER TOUCHED. THE TRANSMISSION WAS PRODUCTED FROM TURNING THE MACHINE ON ONLY. EQUIPMENT WAS DETERMINED TO BE MALFUNCTIONING. THE PT WAS TREATED WITH A HOT PACK. THERE WAS NO SKIN DISCOLORATION OR INJURY OTHER THAN A TEMPORARY SHOCK THROUGH 4 ELECTRODES PLACED OVER HER LOW BACK BILATERALLY.
CUTTING WIRE BROKE DURING USE. 30/30 BLEND; 2 SETTING. PROXIMAL END FRACTURED. THIS IS THE THIRD INCIDENT OF THIS PROBLEM.
#22 GAUGE 6" CATHETER INSERTED INTO LEFT CEPHALIC VEIN WITH PROPER ASEPTIC TECHNIQUE. ADVANCED 6" WITHOUT DIFFICULTY. FLUSHED DURING INSERTION WITH SALINE. GOOD BLOOD RETURN AND EASY FLUSH. LEFT ARM IMMOBILIZED FOR 30 MINUTES. CATHETER FLUSHED WITH WITH 2 ML HEPARIN. FOLLOWING HEPARIN FLUSH, PT EXPERIENCED SOME FACIAL FLUSHING AND THEN DESCRIBED "SHOOTING SHARP PAIN," FROM MID-THORAX REGION TO LOWER BACK AND BUTTOCKS. PT SAID PAIN FELT LIKE "SPASMS." DENIED SOB, BUT DID C/O SLIGHT PAIN UNDER RIGHT RIB DURING INHALATION. PALPATED PULSE AT THIS TIME 110. FACIAL FLUSHING SUBSIDED AND "BUTTOCK PAIN" CONTINUED FOR ABOUT 3 MINUTES. PT EXPERIENCED SOME RELIEF WITH HAND PRESSURE APPLIED TO LOWER BACK ABOVE BUTTOCKS. WITHIN 10 MIN, PAIN DISAPPEARED COMPLETELY." HEART RATE AT THIS TIME 88. PT DENIED ANY SOB, PAIN ON INSPIRATION OR ANY SUBSEQUENT LOWER BACK PAIN. CATHETER REMAINS IN PLACE. FOLLOW-UP WITH PT. PT DESCRIBES AN EPISODE OF CHILLS, FEVER ABOUT ONE 1 HOUR AFTER CATHETER INSERTION. DENIES ANY FURTHER PAIN, SOB OR PAIN AT CATHETER INSERTION SITE. SPOKE WITH DR ABOUT INCIDENT. PT GIVEN P.O. TYLENOL AND BENADRYL. DOCTOR AWARE OF PT'S REACTION AFTER LANDMARK CATHETER INSERTION.
ON 1/5/96 A 24, 6" MIDLINE CATHETER WAS INSERTED BY AN RN IN A DOCTOR'S OFFICE FOR ADMINISTRATION OF IV ROCEPHIN. IMMEDIATELY AFTER INSERTION AND FLUSHING OF CATHETER WITH 0.9NS, PT BECAME FLUSHED AND TACHYCARDIC, C/O CHEST HEAVINESS, ANXIETY AND FEELING OF "IMPENDING DOOM" AND HAD UNCONTROLLABLE SHAKING. DOCTOR EVALUATED AND FELT IT WAS POSSIBLE ADRENALIN SURGE SECONDARY TO ANXIETY. PT WAS OBSERVED AND SYMPTOMS RESOLVED IN LESS THAN 5 MINS WITHOUT REMOVAL OF CATHETER. CATHETER REMAINED IN PLACE FOR 10 DAYS WHEN IT WAS REPLACED BY ANOTHER MFR'S CATHETER. FOR 5 DAYS WITHOUT INCIDENT THERAPY WAS CONCLUDED EARLY SECONDARY TO COMPLICATIONS FROM IV ROCEPHIN. SEVERE CYSTITIS.
32-YR-OLD FEMALE CAME TO OFFICE FOR INSERTION OF MIDLINE CATHETER. PT RECEIVING ROCCPHIN 2 GRAMS DAILY. CATHETER INSERTED PER PROTOCOL USING FLUSHING, FLOATING TECHNIQUE. INSERTED WITHOUT PROBLEM ON 2ND ATTEMPT. 10 MINUTES AFTER INSERTION, PT DEVELOPED TINGLING OF LEFT LOWER LIP AND FACE. A HIVE DEVELOPED WITH SWELLING OF INNER LIP. NO SOB, NO CHEST PAIN, SLIGHT REDNESS TO NECK - BENADRYL 2.5 MG GIVEN. SYMPTOMS RESOLVED IN 1 HOURS. CATHETER LEFT IN PLACE.
COMPANY DISTRIBUTES INLINE FILTERS WHICH HAVE A PLASTIC COMPONENT (A GUARD) ON THE ACTUAL FILTER WHICH CAN BE EASILY DETACHED BY ANY PEDIATRIC PT. THIS 4-YR-OLD PT WAS FOUND IN HIS BED PLAYING THE PLASTIC GUARD. HE COULD HAVE EASILY PLACED IT IN HIS MOUTH AND CHEWED OR ASPIRATED PARTS OF THE PLASTIC. NO COMPONENTS ON SUCH A FILTER OR LINE SHOULD BE SO EASILY DETACHABLE. THIS FILTER, ACCORDING TO THE COMPANY IS MADE BY A LARGE COMPANY WHICH ALSO MFG THE SAME FILTERS FOR OTHER COMPANIES. RPTR FEELS THAT SUCH A DEVICE MAY PLACE PEDIATRIC PTS AT RISK.
PT WAS LYING ON EXAM TABLE PRIOR TO THE PROCEDURE. THE TABLE TILTED SUDDENLY CAUSING THE PT TO SLIDE RAPIDLY DOWN THE TABLE HEAD FIRST. AS A RESULT, THE PT HIT HER HEAD AGAINST THE WALL. IT IS SUSPECTED THAT THE HYDRAULIC CYLINDER BROKE (ACCORDING TO MAINTENANCE STAFF). IT WAS MOST LIKELY THE MECHANISM INSIDE THE CYLINDER.
THE PLASTIC CRACKED. THIS HAS THE POTENTIAL OF CAUSING TRAUMA. THE TUBE WAS CHANGED ON 3/14/96.
THE PLASTIC CRACKED. THIS HAS THE POTENTIAL OF CAUSING TRAUMA. THE TUBE WAS CHANGED ON 3/7/96.
PT BROUGHT TO THE EMERGENCY DEPARTMENT FOR CATHETER REMOVAL. THE CATHETER HAD BEEN PLACED IN A SKILLED NURSING FACILITY, THE WEEK OF 2/26 - 3/2/96. DURING A HOME HEALTH VISIT THE PT COMPLAINED OF PAIN. THE FOLEY WAS NOTED NOT TO BE DRAINING, THE NURSE ATTEMPTED TO DEFLATE THE FOLEY CATHETER AND WAS NOT SUCCESSFUL. THE PORT WAS CUT AND THE BALLOON REMAINED INFLATED. IN THE EMERGENCY DEPARTMENT THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON AND THE UROLOGIST WAS NOTIFIED. THE FOLEY HAD TO BE REMOVED WITH THE BALLOON INFLATED. PT WAS DISCHARGED HOME WITH A NEW FOLEY CATHETER IN PLACE.
IMMEDIATELY AFTER CLOSING AN O2 VALVE ON AN INFANT WARMER THERE WAS A "POP" FOLLOWED BY AN ORANGE GLOW, AND THEN A COMPLETE DISCHARGE OF O2 FROM THE TANK. THERE WAS NO INFANT IN THE WARMER AT THE TIME OF THE INCIDENT. CHECKED UNIT-TANK GASKET. MANIFOLD ASSEMBLY CONNECTOR DISTORTED FROM PRESSURE. RPTR CALLED MFR. THEY RECOMMENDED REPLACING ENTIRE MANIFOLD ASSEMBLY. THIS WAS DONE BY RPTR'S CLINICAL ENGINEERING DEPARTMENT. MFR PLANS TO ANALYZE MANIFOLD; SUPPLIER WILL BE ANALYZING TANK.
CONFUSED PT. FOUND WITH HEAD BETWEEN UPPER SIDERAIL OF BED.
WHEN CIRCULATING NURSE ATTEMPTED TO SPIKE A 500CC BOTTLE OF EYE IRRIGATION, THE AIR FILTER, WHICH WAS ALREADY PRIMED, CRACKED, CAUSING AIR TO INFILTRATE SYSTEM. THIS CAUSED EYE TO COLLAPSE. UNKNOWN IF THERE IS ANY PERMANENT PROBLEM. (*)
RPTR STATED THAT WHILE USING GLOVES DURING A PROCEDURE, HER EYES BECAME SWOLLEN. SHE WENT TO THE ER AND THEY TREATED HER WITH DECADRON CREAM. ON 1/27/96 AND 1/28/96 SHE DEVELOPED SKIN REACTIONS AND A RASH ON HER HANDS. (ALSO SEE 1008640, 1008641, 1008642)
RPTR STATED THAT WHILE USING GLOVES DURING A PROCEDURE, HER EYES BECAME SWOLLEN. SHE WENT TO THE ER AND THEY TREATED HER WITH DECADRON CREAM. ON 1/27/96 AND 1/28/96 SHE DEVELOPED SKIN REACTIONS AND A RASH ON HER HANDS. (ALSO SEE 1008639, 1008641, 1008642)
RPTR STATED THAT WHILE USING GLOVES DURING A PROCEDURE, HER EYES BECAME SWOLLEN. SHE WENT TO THE ER AND THEY TREATED HER WITH DECADRON CREAM. ON 1/27/96 AND 1/28/96 SHE DEVELOPED SKIN REACTIONS AND A RASH ON HER HANDS. (ALSO SEE 1008639, 1008640, 1008642)
RPTR STATED THAT WHILE USING GLOVES DURING A PROCEDURE, HER EYES BECAME SWOLLEN. SHE WENT TO THE ER AND THEY TREATED HER WITH DECADRON CREAM. ON 1/27/96 AND 1/28/96 SHE DEVELOPED SKIN REACTIONS AND A RASH ON HER HANDS. (ALSO SEE 1008639, 1008641, 1008640)
REMOVAL OF RUPTURED IMPLANTS, RESULTING IN ADJUNCT BREAST DISEASE. SYMPTOM: LOW-GRADE FEVER, RASHES, STIFFNESS IN JOINTS, SWELLING IN GLANDS, MIGRAINES, MEMORY LOSS, CHRONIC PAIN, CHRONIC FATIGUE.
RPTR REPLACED THE PLATE AND SCREWS THAT WERE INITIALLY IMPLANTED ON 2/14/96. PLATE HAD BROKEN INTO 2 PIECES. SCREWS WERE NOT BROKEN.
PT PULLED REMOVABLE LEG FROM WHEELCHAIR. PT THEN HIT ANOTHER PT WITH THE LEG REST. CUT ON TOP OF HEAD 5 CM LONG. THE WHEELCHAIR WAS IN GOOD CONDITION. THE LEG THAT WAS TAKEN OFF OF THE WHEELCHAIR IS REMOVABLE. THERE SEEMED TO BE NO DEFECTS IN THE CHAIR OR LEG REST OF THE CHAIR. PT WAS TRANSFERRED TO A MEDICAL CTR. PT WAS TREATED AND RELEASED THE SAME EVENING. PT RECEIVED MULTIPLE SUTURES TO CLOSE 3 SCALP LACERATIONS.
AFTER TPN HAD BEEN HANGING 10 HOURS, TPN TUBING BEGAN FILLING WITH AIR BUBBLES. 3/13/96 TESTED TUBING IN PHARMACY, COULD NOT REPEAT PROBLEM.
HAD ONLY 1 PAIR SALINE FILLED BREAST IMPLANTS FOR 9 1/2 YEARS AND HAD ALL THESE PROBLEMS: FEELING TIRED, RECURRING SHINGLES - THAT NO ONE COULD TELL HER WHY SHE KEPT GETTING. SHINGLES RECURRING ONCE TO TWICE A MONTH SINCE 1987 - 1 YEAR AFTER IMPLANTATION. HAD CAPSULOTOMY 1 YEAR AFTER IMPLANT TO PREVENT HARDENING DUE TO PROBLEM WITH SCAR CAPSULE. NEUROLOGIST DIAGNOSED SILICONE ADJUNCTIVE DISEASE, AUTOIMMUNE DISEASE OF THE ENDOCRINE AND NERVOUS SYSTEM AND MUSCLES ONGOING. ALL THREE OF HER CHILDREN WERE BORN AFTER SHE WAS IMPLANTED AND NEED TESTING DEVELOPED FOR THEM DUE TO PLACENTAL BLOOD.
REMOVAL OF SILICONE BREAST IMPLANT AFTER 14 YEARS IMPLANTED. SHELL OF IMPLANT HAD DISSOLVED INTO SURROUNDING TISSUE. SILICONE GEL RELEASED INTO BODY. IMPLANTED 1980, REMOVED 1994. RESULTED IN ARTHRITIS, SKIN RASH, FATIGUE.
GASTROSTOMY TUBE PLACED 11/23/94. ATTEMPTS TO REMOVE ON 6/22 AND 6/30/95 UNSUCCESSFUL. ON 6/30 OVERTUBE USED AND PT UNDER ANESTHESIA. GASTROSTOMY TUBE TOO FIRM TO FIT THROUGH OVERTUBE. PT WILL NEED AN OPEN PROCEDURE FOR TUBE REMOVAL.
PHYSICIAN UTILIZING THE HAND HELD AND OPERATED SUCTION IRRIGATOR/COAGULATOR WHEN HOLDING FORCEP ATTACHED TO A SEPARATE CORD BURNED A HOLE THROUGH DRAPES AND INTO PT'S CHEEK. EQUIPMENT REMOVED AND CHECKED BY BIOMED; A PLASTIC SURGEON CALLED FOR CONSULT. BURN WASHED WITH H2O AND 1% SILVER SULFADIAZINE APPLIED TO AREA.
INCIDENT OCCURRED WHILE PT WAS USING SUCTION TUBE TO SUCTION THROAT. PT HAD RECENTLY EATEN AND HAD SENSATION THAT FOOD WAS LODGED IN THROAT. ATTEMPTED TO SUCTION TRACHEOSTOMY WITH CATHETER AND CATHETER SNAPPED. CATHETER WAS INSERTED ABOUT TWO INCHES WHEN PT REALIZED WHAT HAD HAPPENED. ATTEMPTED TO REMOVE BY TAKING OUT INNER CANNULA OF TRACHEOSTOMY. CATHETER TIP HAD PASSED BEYOND THAT POINT AND WEGDED IN AIRWAY. REQUIRED SURGERY TO REMOVE CATHETER TIP. AT THE TIME OF THE INCIDENT THE CATHETER WAS NEW AND HAD NOT BEEN USED PREVIOUSLY.
IMMUNOCOMPROMISED PT WAS UNDERGOING A LIVER TRANSPLANT WHEN THE COVER FELL OFF OF THE OR LIGHT HANDLE FALLING INTO THE STERILE OPERATING FIELD. THE PT WAS PLACED IN 5 DAYS OF PROPHYLACTIC ANTIBIOTIC THERAPY.
PT HAD BREAST IMPLANTS PUT IN IN 1988 AND HAD THEM REMOVED IN 1994 DUE TO BILATERAL CAPSULECTOMIES AND THE RIGHT IMPLANT WAS FOUND TO BE RUPTURED.
PT HAD IMPLANT PLACED IN 1989 FOR BREAST RECONSTRUCTION. SHE COMPLAINED OF MANY NONSPECIFIC SYMPTOMS IN 1994 THAT SHE FELT MIGHT BE RELATED TO HER IMPLANT. DEVICE WAS FOUND TO BE RUPTURED WHEN IT WAS EXPLANTED.
PT UNDERWENT BREAST AUGMENTATION IN 1982 AND SINCE THEN HAS HAD VARIOUS COMPLAINTS AND WANTED THE IMPLANTS REMOVED. BILATERAL RUPTURED IMPLANTS WERE FOUND UPON REMOVAL.
PT HAD BREAST IMPLANTS PUT IN IN 1982 AND HAD THEM REMOVED IN 1993. UPON REMOVAL, THE LEFT IMPLANT WAS FOUND TO BE RUPTURED.
PT HAD BREAST IMPLANTS PLACED IN 1981 AND HAD THEM REMOVED IN 1994. THE LEFT IMPLANT WAS FOUND TO HAVE RUPTURED.
PT HAD IMPLANTS PLACED IN 1982 AND HAD THEM REMOVED. UPON REMOVAL, BOTH SILICONE BREAST IMPLANTS WERE FOUND TO BE RUPTURED.
PT UNDERWENT BREAST AUGMENTATION IN 1983 AND LATER HAD THE IMPLANTS REMOVED. UPON REMOVAL, THE LEFT IMPLANT WAS FOUND TO BE RUPTURED.
PT HAD BREAST IMPLANTS PLACED IN 1982 AND HAD THEM REMOVED IN 1992. UPON REMOVAL, THE LEFT IMPLANT WAS FOUND TO BE RUPTURED.
PT UNDERWENT BREAST IMPLANT SURGERY ON 4/13/82 AND HAD THE IMPLANTS REMOVED ON 11/23/94. UPON REMOVAL, THE RIGHT IMPLANT WAS FOUND TO BE RUPTURED.
THE PT WAS BEING SEEN FOR ROUTINE FOLLOW-UP WHEN IT WAS NOTED HIS ICD WAS OVERSENSING. THE ICD HAD BEEN NOTED TO DETECT NOISE AS TACHYARRHTHMIA WHEN ELECTROGRAM WAS REPLAYED. SURGERY WAS PERFORMED AND A BREAK IN THE INSULATION WAS NOTED 5 TO 10 CM FROM THE PULSE GENERATOR WHICH WAS CAUSING THE OVERSENSING. THE LEAD WAS REPLACED DURING SURGERY. THE PT HAD NOT EXPERIENCED ANY PROBLEMS AS A RESULT OF THIS OVERSENSING.
PT SHOCKED IN NORMAL SINUS RHYTHM. LEAD AND GENERATOR REPLACED. QUESTIONED IF OVERSENSING CAUSED BY EPICARDIAL LEAD. LEAD CAPPED. GENERATOR IS AVAILABLE FOR EVALUATION SHOULD THE CO BE INTERESTED IN CONDUCTING AN EVALUATION ON THE GENERATOR.
THE DEVICE WOULD NOT RELEASE DURING AN APPENDECTOMY PROCEDURE ON 12/10/95. THE DEVICE HAD TO BE REMOVED BY THE SURGEON.
PT WAS PREPARING THE COLD PACK FOR HIS WIFE, WHO WAS POST-PARTUM, WHEN THE ICE PACK EXPLODED AND SPLASHED INTO BOTH OF HIS EYES. THIS WAS AN UNWITNESSED EVENT. NURSE REPORTED THAT 2 ICE PACKS HAVE EXPLODED WHILE SHE WAS FOLLOWING DIRECTIONS IN THEIR USE. PT WAS TREATED IN ER WITH DIAGNOSIS CORNEAL ABRASION IN BOTH EYES. (LABEL)
WHEN ABMUBAGGING, THE NEWBORN (31 WKS GESTATION) DEVELOPED BILATERAL PNEUMOTHORAX. TUBING FROM PRESSURE PORT MAY HAVE BEEN CONNECTED TO THE O2 SOURCE. (PORTS WERE SWITCHED). THE TUBING FOR THE PRESSURE MANOMETER AND THE O2 ARE ALMOST IDENTICAL WITH PORTS NOT BEING READILY DISTINGUISHABLE. THEY CAN EASILY BE MISTAKEN FOR EACH OTHER. HOSES COULD BE DIFFERNT COLORS.
SMALL TIP ON INSERTOR WAS MISSING AFTER SURGEON USED INSTRUMENT. X-RAY REVEALED SMALL TIP IN PT'S BONE. SIZE OF METAL EQUAL TO OR LESS THAN 1 MM. NOT REMOVED. NO ADVERSE PT OUTCOME.
VAPOGRAM PERFORMED BECAUSE OF PUFFINESS AROUND INJECTION PORT. VAPOGRAM SHOWED EXTRAVASATION OF CONTRAST WHICH APPEARED TO BEGIN AROUND CATHETER ITSELF NEAR ITS POINT OF ENTRY INTO THE VEIN. QUESTION OF A CRACK IN CATHETER. CONTRAST APPEARED TO DISSECT BACK ALONG TRACK OF CATHETER AND POOL SUPERIOR TO THE PORT.
VESSEL OCCLUDER WAS BEING PULLED TIGHT DURING A PROCEDURE, AND STAFF NOTICED A CLEAR PLASTIC PIECE DROPPED ONTO THE STERILE FIELD OFF THE VESSEL OCCLUDER.
DURING PROCEDURE BALLOON DISSECTOR'S BALLOON RUPTURED. PHYSICIAN RETRIEVED PIECES OF BALLOON FROM PT BY LAPAROSCOPY.
ATTEMPTED TO DISCONTINUE FOLEY. UNABLE TO ADVANCE CATHETER, IRRIGATE CATHETER, OR REMOVE FLUID FROM BALLOON. BALLOON PUNCTURED WITH 22 GAUGE NEEDLE AND THEN REMOVED. NO KNOWN ADVERSE PT OUTCOME. DATE OF FOLEY INSERTION IS UNKNOWN BECAUSE PT CAME INTO HOSP WITH FOLEY.
AFTER VESSEL OCCLUDER WAS APPLIED, SEVERAL PARTICLES APPEARED IN THE WOUND THAT HAD THE APPEARANCE OF GLASS. VESSEL OCCLUDER WAS LATER EXAMINED, AND AFTER OPENING DEVICE, PARTICLES WERE FOUND INSIDE RUBBER TUBE. IT APPEARED THAT THE HARDENED GLUE FROM THE INSIDE RUBBER TUBE WAS BREAKING LOOSE AND FALLING IN THE WOUND.
THE PREPERITONEAL DISTENTION BALLOON WAS PUMPED FORTY TIMES AND AFTER SIXTY SECONDS THE BALLOON RUPTURED. THEN A NEW PREPERITONEAL DISTENTION BALLOON WAS USED. THIS WAS ALSO PUMPED FORTY TIMES AND AFTER SIXTY SECONDS THIS BALLOON ALSO RUPTURED. PIECES OF BALLOON WERE RETRIEVED FROM PT'S PERITONEAL FIELD.
NURSE CALL SYSTEM DID NOT WORK PROPERLY FOR 24 HOURS. SPECIFICALLY, THE PT CALL LIGHT WOULD LIGHT BUT THE ALARM THAT ALERTS THE STAFF WAS NOT WORKING. THE PT INTERCOM SYSTEM DID NOT WORK. THE PT BED ALERT SYSTEM WAS NOT WORKING. THE BED ALERT SYSTEM NOTIFIES THE STAFF OF THOSE PTS WHO ARE ATTEMPTING TO GET OUT OF BED AND ARE AT RISK FOR FALL. TESTS WERE PERFORMED BY CO TECH ON AUGUST 1 - AUGUST 2, 1995.
CUSTOMER TESTED A PT SAMPLE. THE INSTRUMENT RETURNED A VALUE OF 320 SECONDS FOR PT. THE CUSTOMER OBSERVED A FLAT COAGULATION CURVE WITH NO ERROR CODE FLAGGING THE RESULT. THE DUPLICATE TEST YIELDED A RESULT OF 326 SECS WITH A SLIGHT CURVE AND NO ERROR CODE. THE PT HAD PRESENTED TO THE SAME FACILITY ONE WEEK PRIOR WITH A PT OF APPROX 50 SECONDS. THE PHYSICIAN DID NOT BELIEVE THE RESULTS OBTAINED ON 2/12/96. THE INDIVIDUAL SUBMITTING THE REPORT TO CO STATED THAT THE PT "DID NOT BLEED WHEN HE WAS STUCK." THIS CLINICAL OBSERVATION IS NOT CONSISTENT WITH THE PT RESULTS OBTAINED ON 2/26/96.
WHEN THE 20G EPIDURAL CATHETER WAS REMOVED FROM THE PT'S BACK, THE BLUE TIP WAS NOT EVIDENT. WHEN LENGTH OF CATHETER WAS COMPAIRED TO THE LENGTH OF ANOTHER CATHETER IT WAS NOTED TO BE 4CM SHORTER. A NEUROSURGEON WAS CONSULTED AND IT WAS DECIDED IT WOULD BE SAFER TO LEAVE THE FRAGMENT IN THE PT'S BACK THAN IT WOULD BE TO ATTEMPT REMOVAL.
SUTURE FRAYED AND BROKE WHILE SURGEON WAS CLOSING A WOUND. DEVICE TO BE RETURNED TO MFR FOR EVALUATION.
DURING AN INTRAOPERATIVE PROCEDURE THE SUTURE FELL APART. ANOTHER UNIT WAS SUBSTITUTED. DEVICE TO BE RETURNED TO MFR FOR EVALUATION.
SUTURE KEEPS BREAKING WHEN ITS BEING TIED. DEVICE TO BE RETURNED TO MFR FOR EVALUATION.
SUTURE PACKAGE WAS OPENED IN DELIVERY ROOM AND IT WAS FOUND THAT SUTURE MATERIAL WAS NOT CONNECTED TO THE NEEDLE. DEVICE TO BE RETURNED TO MFR FOR EVALUATION.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIP APPLIER MISFIRED AND DID NOT COMPLETELY CLOSE OFF THE DUCT. DEVICE TO BE RETURNED TO MFR FOR EVALUATION.
STAPLER MISFIRED AND DID NOT FORM STAPLE WHEN ATTEMPTING TO USE PRODUCT ON A VAGINAL CUFF. DEVICE TO BE RETURNED TO MFR FOR EVALUATION.
AFTER RECEIVING ELECTRIC SHOCK THERAPY TREATMENTS, MAY THROUGH JUNE, 1965, PT LOST MUCH OF HER LONG TERM MEMORY, AND SHORT TERM MEMORY. SHE HAS HAD TO LIVE BY NOTES FOR THE PAST THIRTY YEARS BECAUSE OF THIS, AND IT HAS ADVERSELY AFFECTED HER ABILITY TO CARRY OUT HER DUTIES AS A SCHOOL TEACHER.
AFTER RECEIVING 40-60 ELECTRIC SHOCK THERAPY TREATMENTS AT AGE 14, PT HAS EXPERIENCED SEVERE, PERMANENT MEMORY LOSS, HAS LOST HER EDUCATION, LOST ABILITY TO READ, WRITE AND DO ARITHMATIC, TO TELL TIME, AND COUNT MONEY. SHE HAS POOR SHORT-TERM MEMORY, AND SEVERELY IMPAIRED WORK SKILLS. ALSO HAS HEARING LOSS, AND FRAGILE BONES ATTRIBUTED TO SHOCK TREATMENTS.
PT HAD ELECTRIC SHOCK THERAPY TREATMENTS IN 1985. SINCE THEN SHE HAS PERMANENT, IRREVOCABLE MEMORY LOSS, HAS DEVELOPED A PERMANENT SEIZURE DISORDER, HAS LOST JOB SKILLS, AND HAS ENCOUNTERED GREAT DIFFICULTY IN OBTAINING AND KEEPING A JOB. ALL ADVERSE REACTIONS ARE RELATED TO ELECTRIC SHOCK THERAPY.
PT HAD ELECTRIC SHOCK THERAPY TREATMENTS IN 1971 AND HAS SUFFERED MEMORY LOSS, INCREASED MENTAL NOISE, DOCILITY, A CHANGED PERSONALITY, AND A FEELING DESCRIBED AS "ZOMBIED" AS A RESULT OF THE TREATMENT.
PT SUFFERED SEVERE, PERMANENT MEMORY LOSS AFTER RECEIVING ELECTRIC SHOCK THERAPY. BECAUSE OF THE TREATMENTS, SHE LOST ABILITY TO PLAY MUSIC, WHICH SHE HAD STUDIED ALL HER LIFE, AND WON AWARDS FOR. BRAIN SCAN A FEW YEARS AGO REVEALED POSSIBLE SCAR TISSUE IN THE FORWARD PART OF THE BRAIN FROM THE TREATMENT.
SEVERE, PERMANENT MEMORY LOSS WAS SUFFERED BY PT AFTER ELECTRIC SHOCK THERAPY TREATMENTS IN 1981. HE HAS LOST THE ABILITY TO WORK IN FORMER PROFESSION.
PT HAD A RUPTURED LEFT BREAST IMPLANT. REMOVED 7/20/92 AT A DIFFERENT FACILITY.
PUMP IN USE FOR PT TO HAVE ANTERIOR CRUCIATE LIGAMENT REPAIR. DURING SURGERY, SURGEON NOTED ABNORMAL SWELLING IN KNEE. DR FURTHER EVALUATED EXTREMITY AND FOUND SEVERE SWELLING IN THIGH. HE CHECKED ALL PUMP CONNECTIONS, INCLUDING IN-FLOW AND OUT-FLOW TROCARS IN KNEE. SURGERY IMMEDIATELY CANCELLED. PT OBSERVED THROUGHOUT THE DAY BY PHYSICIAN. PT DEVELOPED COMPARTMENT SYNDROME AND ADMITTED FOR OBSERVATION. CO CAME TO EVALUATE PUMP AND SPOKE WITH DR. DR STATED THAT PUMP ALARM MALFUNCTIONED. CO FELT THAT PT HAD TEAR IN LATERAL COMPARTMENT OF KNEE AND THEREFORE SENSOR DID NOT ALARM AS HE COULD FIND NOTHING WRONG AFTER THE PRODEDURE.
ON 11/20/95 PT WAS PLACED IN SUPINE POSITION WITH HYDROCULATOR PACKS ON ANTERIOR KNEE JOINT WITH APPROPRIATE PADDING. INTERFERENTIAL STIMULATION TO QUADRICEPS FEMORIS AND ANTERIOR KNEE JOINT WAS INITIATED. PT DID NOT REPORT ANY ILL EFFECTS. EQUIPMENT WAS REMOVED. ON 11/21/95 PT CALLED OFFICE AND INDICATED THAT A BLISTER HAD FORMED AND PHYSICIAN HAD EVALUATED THE BURN. AN INCIDENT REPORT WAS FILED.
DEVICE WAS REMOVED FROM A PT ON 2/10/95. PT INFORMED STAFF THAT A PIECE HAD BROKEN OFF AND WAS REMOVED AT ANOTHER FACILITY ON 1/31/95.
THE PT WAS EXPERIENCING RESPIRATORY DISTRESS. THE DEVICE WAS FOUND TO BE NOT WORKING. RN SUCTIONED PT'S TRACH. NOTIFIED RESPIRATORY THERAPY. PT WAS EVALUATED BY MD.
ON 3/6/96 A RESPIRATORY THERAPIST NOTED DIFFICULTY IN SUCTIONING PT, UNDER DIRECT LARYNGOSCOPY THE ENDOTRACHEAL (ET) 8.0 ORAL/NASAL 10.9 TUBE WAS NOTED TO HAVE A "KINK" AT 20CM. THE ET TUBE WAS REMOVED AND REPLACED WITH ANOTHER ET TUBE.
DURING PREVENTATIVE MAINTENANCE, THE BIOMED TECH WAS DRAWING THE FLUID IN WARMER TO REPLACE. THE FLUID WAS FULL OF BLOOD AND THE TECHNICIAN WAS EXPOSED TO THIS. RPTR DISINFECTED THE UNIT PER MFR'S RECOMMANDATIONS. THEY STATED TWO THINGS CAN CAUSE THIS 1) BAD O RINGS 2) A FAILURE OF THE DISPOSABLE CASSETTE. RPTR INSPECTED THE O RINGS AND ENSURED THESE ARE BEING LUBRICATED ON A MONTHLY BASIS. MFR STATED THIS IS NOT UNCOMMON.
STENT POSITIONED IN LEFT SUBCLAVIAN. STENT BALLOON FAILED TO INFLATE. STENT REPOSITIONED IN RIGHT ILIAC ARTERY AND DEPLOYED THERE.
EIGHTY-TWO INCH EXTENSION SET OPENED AND AN ATTEMPT MADE TO PRIME TUBING. MALE EXTENSION, WHICH IS FURTHEST AWAY FROM PT, WAS DEFECTIVE AND DID NOT ALLOW FLUID TO PASS THROUGH. CLOSER EXAMINATION REVEALED THAT CONNECTION HAD NOT BEEN "BORED OUT" TO ALLOW FLUID TO FLOW INTO TUBING AND EVENTAULLY INTO PT. THE AREA OF LUER WHERE TUBING IS INSERTED WAS COMPLETELY INTACT, WITH NO EXIT.
TECHNICIAN OPENED THE DEVICE AND NOTED LINT (A PIECE OF COTTON) IN THE PACKAGE.
HAPTIC BROKE AFTER INSERTION OF LENS DURING ROTATION. LENS REMOVED, NEW LENS INSERTED.
EQUIPMENT INSERTED INTO CAVITY DURING LAPAROSCOPIC GALLBLADDER SURGERY. THEN IT WAS OPENED BY SURGEON. AFTER THAT, IT WAS "HUNG." IT WOULD NOT OPEN ANY FURTHER OR CLOSE AT ALL. IT WAS WITHDRAWN FROM THE PT IN THE OPENED POSITION BUT DID NOT INJURE THE PT. PHYSICIAN WOULD LIKE EQUIPMENT EXAMINED FOR POSSIBLE DEFECTS.
RPTR WORKED AS AN INDEPENDANT CONTRACTOR FOR A BUSINESSMAN. RPTR WENT TO VARIOUS DOCTORS' OFFICES TO PERFORM DIAGNOSTIC TESTS. THE BUSINESSMAN DID THE BILLING FOR THE SERVICES. THE EQUIPMENT USED WAS FAULTY. DURING THE EXAM HIS MACHINE DID NOT HAVE COLOR AND THE DOPPLER STOPPED WORKING. BUSINESSMAN STILL BILLED PTS FOR SERVICES THAT THE CUSTOMERS DID NOT GET. HE ORDERED TESTS THAT WERE NOT NEEDED.
RPTR WORKED AS AN INDEPENDENT CONTRACTOR FOR A BUSINESSMAN. RPTR WENT TO VARIOUS DOCTORS' OFFICES TO PERFORM DIAGNOSTIC TESTS. THE BUSINESSMAN DID THE BILLING FOR THE SERVICES. THE EQUIPMENT USED WAS FAULTY. DURING THE EXAM HIS MACHINE DID NOT HAVE COLOR AND THE DOPPLER STOPPED WORKING. BUSINESSMAN STILL BILLED PTS FOR SERVICES THAT THE CUSTOMERS DID NOT GET. HE ORDERED TESTS THAT WERE NOT NEEDED.
RPTR HAS BEEN DIAGNOSED WITH ATYPICAL RHEUMATIC SYNDROME BY A BOARD CERTIFIED DR. SHE C/O CHRONIC FATIGUE, SLEEP DISTURBANCE, LOW GRADE FEVER, NUMBNESS OF HANDS AND FINGERS, BLADDER IRRITABILITY, RAYNAUD'S PHENOMENON, MUSCLE WEAKNESS, MORNING STIFFNESS IN HANDS, POOR CONCENTRATION, MEMORY LOSS, BRUISES EASILY, CHEST PAIN, PHOTOSENSITIVITY.
SUPRAPUBIC CATHETER BROKE OFF DURING REMOVAL - FOUND ON READMISSION FOR BLADDER CALCULUS REMOVAL.
MEDICAL ENGINEERING CORP. 2317 EATON LANE, RACINE, WI 53404. THIS PRODUCT WAS NEVER MFG BY THE COOPER SURGICAL SUBSIDIARY PURCHASED BY MEDICAL ENGINEERING CORP, NOR WAS IT EVER MFG BY MEDICAL ENGINEERING CORP.
AN RN INSERTED A CATHETER INTO PT WITHOUT DIFFICULTY. THE PT IMMEDIATELY COMPLAINED OF THROAT DISCOMFORT. THE RN REMOVED THE CATHETER. PT'S SYMPTOMS PROGRESSED FROM THE THROAT TO THE UPPER CHEST. THE PT HAS HAD CHRONIC RED RAISED RASH FOR 6 MONTHS AND HAS NOW DEVELOPED 3 CM DIAMETER BLANCHED, RAISED WHEELS ON ARMS AND TORSO. PT ALSO COMPLAINED OF LIGHT HEADEDNESS. BLOOD PRESSURE WITHIN NORMAL LIMITS. ALL SYMTOMS RESOLVED WITHIN 60 MINUTES OF ONSET. BEING TREATED FOR LYME DISEASE. NO OTHER HISTORY.
ON 3/3/96 RESIDENT WAS BEING WHEELED IN THE SHOWER CHAIR. THE BOTTOM LEFT CROSSBAR BROKE AT THE JOINT. THE RIGHT BACK LEG AT THE UPPER PART OF THE JOINT ALSO BROKE. (LEFT AND RIGHT WHEN STANDING IN BACK OF CHAIR LOOKING FORWARD). WHEN THE CHAIR BROKE THE RESIDENT FELL BACKWARDS HITTING THEIR HEAD ON THE EMPLOYEES DIAPHORETIC AND UNRESPONSIVE FOR 10 SECS. THE PT ALSO C/O OF A SLIGHT HEADACHE. THE RECHECK ON VITAL AND NURO SIGNS WAS OK.
THE TIBIAL COMPONENT WAS REMOVED AT THE PT'S REQUEST. THE COMPONENT WAS IMPLANTED IN 1984. CURRENTLY THE IMPLANT APPEARS WORN WHICH MAY BE EXPECTED.
THE PT HAD BREAST IMPLANTS IN 3/78. THE PT IS NOW HERE AT A DIFFERENT HOSPITAL FOR REMOVAL OF RUPTURED IMPLANTS. DR WHO WAS NOT THE ORIGINAL DOCTOR MADE MULTIPLE CALLS TO THE ORIGINAL HOSP TO OBTAIN "EXPLANT" INFO BUT WAS UNSUCCESSFUL AND RPTR CANNOT DETERMINE THE MFR.
PER PT FAMILY REPORT:  FAMILY RENTED VENTILATOR W/ ATTACHMENTS & ACCESSORIES FROM DIST.  PT AWOKE EARLY A.M. & REALIZED HE WAS NOT RECEIVING O/2 AND ALARM HAD NOT SOUNDED.  GIVEN 0/2 FROM PORTABLE TANK AND VENTILATOR & CONCENTRATOR RETURNED TO DIST.  DIST REPORTS CHECKED AND NO DEFECTS IDENTIFIED.  PT W/CHANGED MENTAL STATUS OVER NEXT SEVERAL DAYS.  SINCE RETURNED TO NORMAL.
DURING ANGIOPLASTY, ON SECOND INFLATION OF BALLOON, THE PROXIMAL RIGHT CORONARY ARTERY AND ASCENDING AORTA DISSECTED.  THIS NECESSITATED OPEN HEART SURGERY AND THE PT DIED IMMEDIATELY FOLLOWING SURGERY.
PT NOTED TO HAVE COUGHED UP GREENISH FLUID IDENTIFIED AS COLOR ADDITIVE TUBE FEEDING SOLUTION.  ATTEMPT TO SUCTION FEEDING TUBE DEMONSTRATED AIR LEAK.  FEEDING TUBE REMOVED AND SLIT IN TUBE NOTED APPROX. 13" FROM AREA OF PINK TAPE MARKED ON TUBE.PT REQUIRED PULMONARY SUCTIONING, CHEST X-RAYS.
AN INCIDENT OCCURRED DURING A URETERAL STENT PLACEMENT INVOLVING AN INTRODUCER SHEATH. THE SHEATH WAS PLACED WITHOUT INCIDENT AND A 6 FR STENT WAS ADVANCED THROUGH THE SHEATH WITH DIFFICULTY. MUCH RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE STENT. EVENTUALLY THE STENT WAS PLACED AND PLACEMENT WAS CONFIRMED UNDER FLUOROSCOPY. UPON REMOVAL OF THE SHEATH RESISTANCE WAS ENCOUNTERED. CONTINUAL EXERTION RESULTED IN THE HUB AND STRAIN RELIEF DETACHING FROM THE SHEATH WHICH REMAINED IN THE PT. THE SPRING FROM THE HUB REMAINED ON THE GUIDE WIRE INSIDE OF THE PT. A BALLOON CATHETER WAS ADVANCED OVER THE WIRE AND USED TO RETRIEVE THE SPRING. THE INTRODUCER SHEATH COULD NOT BE LOCATED AND AFTER FURTHER EXAMINATION IT WAS FOUND THE SHEATH REMAINED AROUND THE STENT. THE SHEATH AND STENT WERE REMOVED AS A UNIT AND ANOTHER INTRODUCER SHEATH AND STENT WERE USED SUCCESSFULLY. THE PT EXPERIENCED NO SEQUELAE AS A RESULT OF THIS EVENT.
WHILE USING THE PHACO EMULSIFIER, THE PT EXPERIENCED ANTERIOR CHAMBER COLLAPSE. WHEN THE FOOT PEDAL WAS RELEASED, THE POSTERIOR CAPSULE WAS PULLED INTO THE HANDPIECE. SUBSEQUENTLY, A VITRECTOMY WAS PERFORMED.
DURING THE TRANSFER OF A PT FROM ICU TO SURGERY, THE IABP UNIT SEPARATED FROM THE BASE ASSEMBLY AND FELL OVER ONTO THE FLOOR, CAUSING THE DISPLAY TO BLANK OUT. THE LATCH IS LOCATED IN THE LOWER POWER CORD STORAGE COMPARTMENT. THE LATCH IS NOT LABELED AND IS EASILY UNLOCKED BY MOVEMENT OF THE POWER CORD AS IT IS STORED AND RETRIEVED FROM THIS COMPARTMENT THE IABP IS DESIGNED FOR TRANSPORT PURPOSES. BUT RPTR'S CONCERN THAT THE DESIGN SHOULD BE IMPROVED TO PREVENT ANY POTENTIAL LIFE THREATENING INCIDENTS.
MULTIPLE PROBLEMS WITH NEEDLES & SYRINGES: 1) CORING OF RUBBER STOPPERS  DUE TO DULL, POORLY LUBRICATED NEEDLES. 2) RUBBER END OF PLUNGER PISTON IS  SOMETIMES CROOKED, RESULTING IN INACCURATE MEASUREMENT. FLANGES OF SYRINGE COLLAR ARE TOO SMALL TO GRASP WHILE USING PROPER ASEPTIC TECHNIQUE. PROBLEMS HAVE OCCURRED WITH ALL "MODELS" AND SIZES USED.
THE PT HAD A LUMBAR FUSION OF L5-S1 FOR SPONDYLOLISTHESIS IN 1994 WQITH A BONE GRAFT ANDD PLACEMENT OF PEDICLE SCREWS ON THE R & L SIDE. PT'S BACK FUSED ON X-RAY CLINICALLY. THE R S-1 PEDICLE SCREW IS FRCATURED, BUT THE REMAINDER OF THE SCREWS ARE ALL FINE. PT HAS LEFT SIDED PAN AND WANTS HIS HARDWARE OUT, BUT HAS NO SYMPTOMS FROM THE BROKEN SCREW. THE PT HAS THE DEVICE.
THE VENTILATOR MADE A HISSING NOISE, THEN POPPED (A POPPING NOISE) AND THEN QUIT WORKING. (ALSO SEE 1008685)
ULTRASONIC PACHYMETER MEASURING 30-40 MICRONS TOO DEEP ACCORDING TO SUBSEQUENT CLINICAL AND FACTORY CALIBRATION OF THE INSTRUMENT.  THIS INACCURACY OF MEASUREMENTS RESULTED IN ABNORMALLY DEEP SETTINGS ON THE DIAMOND BLAD PRODUCING CORNEAL MICROPERFORATIONS IN 2 OUT OF 3 REFRACTIVE SURGERY PATIENTS DONE THAT DAY (12/2/93)
SEE 1008684 AT END OF TEXT ALSO SEE 1008684. VENTILATOR MADE A HISSING NOISE, THEN POPPED (A POPPING NOISE) - THEN QUIT WORKING.
PT IS POST-OP HEART SURGERY. CONDENSATION WAS NOTED INTHE TUBING AND A LOSS OF AUGMENTATION WAS NOTED. "STHE BALLOON ALARMED WITH CATHETER ALARM." NO BLOOD WAS NOTED IN THE TUBING. BECAUSE THE BALLOON WAS A CUTDOWN, THE PT WAS RETURNED TO SURGERY FOR REMOVAL.
AS REPORTED TO DIST BY VISITING NURSE, MOTHER WAS CHECKING ON TWIN ABOUT 9:00 A.M. 11/29/93 AND FOUND SECOND TWIN UNRESPONSIVE, MOTHER REPORTED BRADYCARDIA LIGHT ILLUMINATED BUT APNEA MONITOR WAS NOT ALARMING.
THE MOTHER BOARD) OF THE X-RAY UNIT HAS FAILED ON 4 UNITS IN THE LAST 6 MONTHS. THIS SEEMS TO BE EXCESSIVE AND MAY INDICATE A DESIGN OR PRODUCT PROBLEM.
BOTH IMPLANTS RUPTURED, AT AN UNKNOWN TIME. THE PT WAS DIAGNOSED WITH  DEMYLINATING POLYNEUROPATHY AND A BRAIN SPECT CAME BACK WIH ABNORMALITIES ASSOCIATED WITH TOXIC CHEMICAL EXPOSURE. THE PT'S NEUROLOGIST ADVISED THEM TO HAVE THE IMPLANTS REMOVED AND NOT REPLACED WITH ANY OTHER TYPED IMPLANT.THE PT'S CONDITION HAS IMPROVED SOEMWHAT WITH THE EXCEPTION OF MUSCLE & JOINT PAIN, FATIGUE, & HEADACHES, AND ALSO RECURRENT SHINGLES.
A PT WAS DISCOVERED WITH THE 8.5 FR INTRODUCER DISCONNECTED BETWEEN THE HEMOSTASIS VALVE AND THE SHEATH.  ACCORDING TO REPORTER THE INTRODUCER WAS PLACED BY SUGERY TWO DAYS EARLIER.  THE PT EXPIRED THE FOLLOWING DAY.
ON 1/5/96 THE PT'S SIBLING STEPPED ON THE PILL LINE TUBING. THE PICC LINE BROKE. THE PT'S LINE PULLED OUT AND REINSERTED PER IV THERAPIST AT THE HOSP. ON 1/24/96 DURING A DRESSING CHANGE TO THE LINE, THE PICC LINE BROKE APPROX. 2" FROM THE INSERTION SITE. HE WAS REPAIRED PER THE "SN". IT FLUSHED WELL AND WAS USED FOR INFUSION. BOTH OCCURRENCES TOOK PLACE IN THE PT'S HOME.
A PT WITH DEFIBRILLATOR (AICD) RECEIVED MULTIPLE SHOCKS. A BEEP-O-GRAM NOTED ERRATIC BEEPING TONES FROM THE AICD WHEN THE PT WAS TURNED FROM SIDE TO SIDE. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE TO EVALUATE THE SYSTEM AND ELECTED TO REMOVE THIS LEAD AND ANOTHER SAME LEAD MODEL FROM SERVICE BECAUSE OF A SUSPECTED FAILURE OF THE LEADS. THE PHYSICIAN ALSO ELECTED TO REPLACE THE AICD BECAUSE THE POCKET WAS OPEN AND THE AICD HAD BEEN IMPLANTED APPROX TWO YEARS. THERE WAS NO ALLEGATION AGAINST THE AICD. THE PHYSICIAN ALSO ELECTED TO IMPLANT AN IMPLANTABLE PULSE GENERATOR BECAUSE THE PT HAD EXPERIENCED SYMPTOMATIC BRADYCARDIA. WHILE THE PHYSICIAN WAS CLOSING THE POCKET, THE PT'S BLOOD PRESSURE DROPPED AND DESPITE AGGRESSIVE RESUSCITATION ATTEMPTS, THE PT DIED. THE PHYSICIAN BELIEVES IT WAS A  NONARRYTHMIC DEATH.
RIGHT PATELLA PROSTHESIS.  BLEEDING EPISODE IN OCTOBER 1993.  POST-OP DIAGNOSIS - METALLOSIS OF THE JOINT WITH HEMARTHROSIS.
A PT WITH DEFIBRILLATOR (AICD) RECEIVED INAPPROPIATE SHOCKS. THE PHYSICIAN PERFORMED AND INVASIVE PROCEDURE AND FOUND AN ABRASION ON ONE OF THE PT'S RATE SENSING LEADS 4 CM FROM THE CONNECTOR. THE PHYSICIAN ELECTED TO REMOVE THE LEADS FROM SERVICE AND IMPLANT A BIPOLAR ENDOCARDIAL TINED LEAD THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANT DATE-NA. REMOVED FROM SERVICE-NA TOTAL IMPLANT TIME-APPROX 34 MO.
THE PT HAD HER ORIGINAL PRIMARY KNEE DONE IN 1986. IN 1994 THE STARTED COMPLAINING OF SEVERE PAIN. REVISION SURGERY REVEALED THE ANTERIOR MEDIAL ASPECT OF THE PLASTIC WAS BROKEN OFF. FEMALE IS 80 YRS OLD.
SURGEON BELIEVES THAT DUE TO PT OBESITY PATELLA DISLODGED FROM BONE AND CAUSED SEVERE SYNOVITIS AND ANTERIOR PLASTIC WEAR OSTEOARTHRITIS ON TIBIAL COMPONENT, FEMALE PT IS 71 YRS OLD.
DEVICE HAS NOT BEEN RETURNED TO MFR FOR EVALUATION. DR REMOVED THE TIBIAL  COMPONENT AND METAL BACKED PATELLA AND REPLACED THEM WITH ANOTHER INSERT AND MODULAR PATELLA. THE ORIGINAL COMPONENTS SHOWED EVIDENCE OF WEAR TO THE POLY. FEMALE PT IS 85 YRS OLD.
DEVICE HAS NOT BEEN RETURNED TO MFR FOR EVALUATION. DR REMOVED THE TIBIAL COMPONENT AND METAL BACKED PATELLA AND REPLACED THEM WITH ANOTHER INSERT AND MODULAR PATELLA. THE ORIGINAL COMPONENTS SHOWED SOME EVIDENCE OF WEAR TO THE POLY. MALE PT IS 70 YRS OLD.
DR SUSPECTED WEAR OF THE POLY COMPONENTS. HE CONFIRMED THIS INTRAOPERATIVELY AND REMOVED THE TIBIAL INSERT AND THE METAL BACKED PATELLA. HE REPLACED THE COMPONENTS WITH A NEW INSERT AND A MODULAR POLY PATELLA. MALE PT IS 76 YRS OLD.
A 49 YR OLD FEMALE PT PRESENTED TO THEN HIGH TIBIAL OSTEOTOMY, THEN TOTAL KNEE. AT TOTAL KNEE SURGERY A SIGNIFICANT AMOUNT OF PROXIMAL TIBIA WAS REMOVED BECAUSE OF OF TIBIAL DEFECT, IT APPEARS THAT AN EXCESSIVE POSTERIOR TIBIAL SLOPE; COUPLED WITH LOSS OF POSTERIOR CRUCIATEE LIGAMENT PRODUCED AN UNSTABLE KNEE, PUTTING TREMENDOUS FORCES ON TIBIAL INSERT RESENTING IN A DISSOCIATION OF INSERT FROM BASEPLATE. TIBIAL INSERT WAS LOOSE IN JOINT AND BASEPLATE WAS LOOSE FROM TIBIA AT TIME OF REVISION. BOTH WERE REMOVED. THE SURGEON OPTED TO USE AN INTERMEDICS TIBIAL REVISION BASEPLATE (PRESS-FIT) AND AN A-P CONSTRAINED INSERT, AFTER REVISING TIBIAL SLOPE. THE FEMUR AND TIBIAL IMPLANTS WERE NOT REVISED.
KNEE BEGAN DRAINING AND APPEARED TO BE INFECTED. KNEE WAS OPENED AND DEBIDED AND PATELLECTOMY WAS PERFORMED. INFECTION WAS LOCATED UNDER TIBIAL BASEPLATE. IT WAS REMOVED. TIBIA WAS RECUT AND FLUSHED WITH ANTIBIOTIC SALINE. NEW BASEPLATE AND INSERT WERE IMPLANTED. A STEM EXTENDER WAS ADDED TO THE NEW BASEPLATE. FEMALE PT IS 73 YRS OLD.
PT WHO HAS DEFIBRILLATOR (AICD) RECEIVED INAPPROPIATE SHOCKS. THE PHYSICIAN PERFORMED AN INVASIVE PROEDUE TO ACCESS THE SYSTEM AND ELECTED TO REMOVED BOTH SAME MODEL LEADS FROM SERVICE. THE AICD REMAINS IMPLANTED AND FUNCTIONS APPROPIATELY. IMPLANTED-7/19/92. REMOVED FROM SERVICE-APPROX. 5/27/94. TOTAL IMPLANT TIME-22 MO.
THIS LEAD AND A SAME MODEL LEAD WERE REMOVED FROM SERVICE BECAUSE ON NONCONVERSION OF VENTRICULAR FIBRILLATION. THE PHYSICIAN ALSO ELECTED TO EXPLANT THE LEADS. CO SUBMITTED A SERIOUS INJURY REPORT TO THE FDA ON THE PT LEADS AND THE AICD ON 6/9/94.IMPLANT DATE-2/11/92. REMOVED FROM SERVICES-5/31/94. TOTAL IMPLANT TIME-27 MO.
WHILE TRYIMG TO REDUCE FRACTURE USING ROD AS PRYBAR, THE ROD FRACTURED THROUGH THE PROXIMAL HOLE. MALE PT IS 22 YRS OLD.
PT IS EXPERIENCING PAIN. POLY WAS SEVERLY WORN. PUT IN VARUS WITH TOO THIN  OF AN INSERT. MALE PT IS 69 YRS OLD AND WEIGHS 250 LBS.
7/19/95: R.N. ATTEMPTED TO REMOVE FOLEY CATHETER BY DEFLATING BALLOON. BALLOON WOULD NOT DEFLATE. UROLOGIST SAW PT ON CONSULT: UNSUCCESSFUL ATTEMPT BY UROLOGIST TO REMOVE FOLEY OM 7/19/95. BALLOON WOULD NOT DEFLATE. 7/20/95: UROLOGIST ATTEMPTED CYSTOSCOPY DONE AND CATHETER REMOVED THROUGH BLADDER INCISION WITH BALLOON STILL INFLATED WITH FLUID.
FACILITY ALLEGES LEUR CONNECTION SEPERATED FROM SET TUBING DURING DIALYSIS.  OCCURRED TWO HRS INTO DIALYSIS - BOTH ATERIAL & VENOUS LINES.  ESTIMATED BLOOD LOSS APPROX 100CC.  PT STABLE.  POST EVENT.  NO FURTHER MEDICAL INTERVENTION REQUIRED.
PT RETURNED AN OPENED BOX OF INSULIN SYRINGES TO PHARMACY WHICH WAS DISPENSED ON 10/6/95. THE INDIVIDUAL SYRINGE WAS SEALED, BUT NO SYRINGE WAS INSIDE THE WRAP.
RPTR NOTED THAT EACH BOX OF TEST STRIPS NORMALLY INCLUDES A TYPE OF COMPUTER CHIP WHICH IS PLACED INTO THE METER TO CALIBRATE THE METER TO THE INDIVIDUAL BATCH OF TEST STRIPS. THIS PARTICULAR PRODUCT WAS MISSING THE CHIP TO CALIBRATE THE MACHINE.
UNDER SPINAL ANESTHESIA LEFT FEMORAL HEAD REMOVED AND UNIPOLAR HIP PROSTHESIS WITH CEMENT WAS IMPLANTED. IMMEDIATELY AFTER PLACEMENT OF CEMENT PT DEVELOPED HYPOTENSION, BECAME UNCONSCIOUS AND STOPPED BREATHING. SHOCK STATE MANAGED.
THE MFR'S POLYHESIVE PACKAGE DOES NOT MEET ITS GUARANTEE OF STERILITY. THE POLYHESIVE PACKAGE WAS BEING OPENED FOR USE AND WHEN REMOVED FROM THE PREVIOUSLY-SEALED PACKAGE, SEVERAL PIECES OF HAIR WERE ON THE PADS.
THE BAGS ARE BREAKING UNDER NORMAL USAGE. THE BAGS ARE TOO THIN. PROBLEM HAS ONLY RECENTLY HAPPENED WITH THE LAST TWO ORDERS.
THE CLINIC WAS SUPPLIED WITH SEVERAL BOXES OF 26 GAUGE NEEDLES, MADE BY MFR. THE CLINIC SOP REQUIRES THESE NEEDLES BE USED TO PERFORM MOST ALLERGY PROCEDURES. THE ALLERGY TECHNICIAN WILL DRAW UP THE MEDICATION IN ONE NEEDLE, THEN SWITCH NEEDLES. THIS NEEDLE IS THE SECOND NEEDLE USED IN THE PROCEDURE. ON SEVERAL OCCASIONS, THE NEEDLE HAS POPPED OFF WHILE GIVING AN ALLERGY SHOT, CAUSING UNDUE PAIN TO THE PTS.
4 X 8 RADIOPAQUE GAUZE. THIS ITEM IS UNACCEPTABLE IN ITS PRESENT CONDITION. DUE TO THE UNCERTAIN STATUS OF THE PACKAGE'S STERILITY RPTR IS UNABLE TO TAKE THE CHANCES OF USING THESE ITEMS ON SURGICAL PROCEDURES THAT MAY CAUSE HARM TO PTS. RPTR WOULD LIKE TO GET THIS SERIOUS PROBLEM RESOLVED AS SOON AS POSSIBLE BEFORE MORE ARE SENT TO THE WAREHOUSE. FROM THE OUTSIDE OF THESE PACKAGES, THERE SEEMS TO BE SOME MILDEW OR BROWN SPOTS THAT APPEAR ON TOP OF THE PAPER SEAL. THIS QUESTIONABLE DAMAGE TO THESE ITEMS CAN ONLY POINT TO SOME TYPE OF BREAKAGE IN ITS GUARANTEED STERILITY.
RPTR RECEIVED CALL FROM A SURGERY TECHNICIAN. HE INFORMED MEDICAL EQUIPMENT REPAIR OF AN APPARENT ANESTHESIA MACHINE MALFUNCTION. IT HAD REPORTEDLY STOPPED DELIVERING OXYGEN TO THE PT. THEY IMMEDIATELY SWITCHED TO BOTTLED OXYGEN WITHOUT SUCCESS. THERE ARE CONFLICTING REPORTS ABOUT WHETHER THE INCOMING OXYGEN GAUGE DISPLAYED PROPER PRESSURE OR NOT. IN HOPES OF RESOLVING THE PROBLEM, A TECHNICIAN LEFT THE ROOM TO GET A NEW BOTTLE OF OXYGEN; BUT, BY THE TIME HE RETURNED, THE ANESTHESIA MACHINE HAD RETURNED TO NORMAL OPERATION. SINCE THE PROCEDURE WAS NEARLY FINISHED, THE MACHINE WAS USED TO FINISH THE CASE. AS SOON AS THE CASE WAS COMPLETED THE ANESTHESIA MACHINE WAS REMOVED FROM SERVICE. A FOLLOW-UP CALL ON 2/9/96 REVEALED THAT THE MACHINE IN QUESTION HAS OPERATED PERFECTLY SINCE THE INITIAL PROBLEM WAS REPORTED AS HAVE THEIR OTHER THREE UNITS.
RPTR'S FACILITY HAS RECEIVED SEVERAL COMPLAINTS ABOUT THE QUALITY OF MFR'S CONDOMS. PUBLIC HEALTH AND EMERGENCY ROOM HAVE RECEIVED ABOUT 45 COMPLAINTS COLLECTIVELY. THE CONDOMS BREAK EASILY DURING USE, AND THEY ARE NOT FITTING PROPERLY (TOO SMALL). PUBLIC HEALTH STATED THAT THESE CONDOMS ARE UNFIT FOR THEIR INTENDED USE. RPTR HAS SUSPENDED AND REMOVED ALL STOCK FOR ISSUE AND USE.
LUKENS MED CORP. 500 LASER RD, RIO RANCHO, NM 87124. WHEN THE RETAINED PACKAGES WERE OPENED, THE SEALS ON BOTH THE PRIMARY AND SECONDARY PACKAGES WERE FOUND TO BE NORMAL AND ACCEPTABLE. THE SUTURE CARRIER AND SUTURE CONTAINED IN EACH OF THE PACKAGES WERE FOUND TO BE MOIST AND THE SUTURES WERE FOUND TO BE PLIABLE. 6.1 THE STERILITY STUDY RESULTS FOR BOTH THE WET AND DRY CONFIGURATIONS SHOWED ZERO POSITIVES AFTER 14 DAYS.
STERILITY IN PACKAGING IS IN QUESTION. ALSO WHEN THE SUTURE WAS OPENED IT WAS DRY AND BRITTLE.
AFTER PHYSICIAN ORDERED THE FOLEY CATHETER TO BE DISCONTINUED FROM A PT, A STAFF MEMBER PROCEEDED TO PERFORM THE PROCEDURE. PROCEDURE EXPLAINED TO THE PT, 10CC SYRINGE INSERTED TO DEFLATE THE BALLOON, 6CC OF WATER EXPELLED. MORE FLUID WAS SUSPECTED TO BE IN THE BALLOON AND THE PROCEDURE WAS REPEATED, ANOTHER CC OF WATER DISCARDED. WHEN THE PORT WAS CUT, NO FLUID CAME OUT FROM THAT PORT SO STAFF MEMBER PULLED THE CATHETER. HE MET RESISTANCE. HE CUT THE BALLOON PORT WITH SCISSORS. WHEN THE PORT WAS CUT, NO FLUID CAME OUT FROM THAT PORT SO STAFF MEMBER WENT AHEAD AND PULLED THE CATHETER. WHEN THE CATHETER WAS PULLED OUT, THERE WAS STILL 1 1/2 - 2 CC OF FLUID INSIDE THE BALLOON WHICH CREATED DISCOMFORT TO THE PT. WHEN THE BALLOON PORT THAT CONTAINS THE INJECTION VALVE WAS CUT, ANY FLUID IN THE BALLOON SHOULD AUTOMATICALLY COME OUT. THE BALLOON SHOULD DEFLATE ITSELF.
NASAL CANNULAS HAVE A PROTRUSION UNDER THE NASAL PRONGS THAT HAS BEEN FOUND TO BE VERY IRRITATING TO THE PATIENTS, CAUSING AN ABRASION. CANNULA IS ALSO VERY STIFF. RPTR WILL USE UP STOCK ON HAND AND SWITCH OVER TO A SOFTER, PLIABLE AND MORE COMFORTABLE CANNULA PENDING CORRECTIVE ACTION BY MFR.
DOCTOR ATTEMPTED TWICE TO PLACE A FEMORAL CENTRAL LINE (BOTH FROM SAME LOT NUMBER) INTO A PT. ON BOTH ATTEMPTS THE GUIDE WIRE UNRAVELLED WHILE THREADING IT THROUGH THE TRIPLE LUMEN CATHETER. (NOTE: THE OUTER WRAPPING SEPARATED FROM THE CENTRAL WIRE). THIS COULD HAVE BEEN POTENTIALLY LIFE-THREATENING TO THE PT. AS A RESULT THE DOCTOR WAS UNABLE TO GET A CENTRAL LINE TO THE PT.
SIX OUT OF NINE DOCTORS HAVE HAD SOME SORT OF REACTION TO THESE LATEX MEDICAL GLOVES. THEIR HANDS TEND TO BREAK OUT IN A RASH. IN SEVERE CASES, THE SKIN TENDS TO DRY, CRACK, AND BLISTER IN ADDITION TO THE RASH. SINCE THESE SAME DOCTORS HAVE NEVER HAD ANY SIMILAR REACTIONS TO THE LATEX MEDICAL GLOVES THAT WERE SUPPLIED IN THE PAST, MANY FEEL THAT IT MAY BE THE POWDER LINE IN THIS PARTICULAR BRAND OF GLOVES.
SEVEN OUT OF NINE DOCTORS HAVE HAD SOME SORT OF REACTION TO THESE LATEX MEDICAL GLOVES. THEIR HANDS TEND TO BREAK OUT IN A RASH. IN SEVERE CASES, THE SKIN TENDS TO DRY, CRACK, AND BLISTER IN ADDITION TO THE RASH. SINCE THESE SAME DOCTORS HAVE NEVER HAD ANY SIMILAR REACTIONS TO THE LATEX MEDICAL GLOVES THAT WERE SUPPLIED IN THE PAST, MANY FEEL THAT IT MAY BE THE POWDER LINE IN THIS PARTICULAR BRAND OF GLOVES.
A DOCTOR IN THE FACILITY WAS PREPARING TO START AN IV ON AN INFANT. THE DOCTOR OPENED THE PACKAGE CONTAINING THE 23GA USE BUTTERFLY AND NOTICED A YELLOW COATING OF SOME KIND ON THE TIP OF THE NEEDLE.
FILTER HAS PINPOINT HOLES AND MALE ADAPTER LEAKS. THE MOLD THAT IT WAS MADE FROM MUST BE DEFECTIVE BECAUSE IT LEAKS FROM THE TOP PORTION OF THE BLUE PLASTIC FILTER; SOME ARE COMPLETELY ROUND, OTHERS ARE NOT AND THAT IS WHERE IT LEAKS. SOME FILTERS HAD HOLES IN THE PLASTIC DOME PORTION OF THE FILTER. ALSO, WHEN FILTERS ARE PURGED THERE ARE AIR BUBBLES THAT PASS THE FILTER PORTION.
THIS ITEM DOES NOT MEET THE NEEDS OR STANDARDS FOR USE IN THE OPERATING ROOM. THE PRODUCT IS STERILE, WHICH IS NOT BEING QUESTIONED. THE PRODUCT CANNOT BE OPENED AND PLACED ONTO A STERILE FIELD WITHOUT BEING CONTAMINATED. THEREFORE, THIS PRODUCT CAN NO LONGER BE USED IN THE OPERATING ROOM.
WHEN THE DOCTOR PULLED THE SIZE 8 GLOVES OUT OF THE SEALED PACKAGE, DATED 2/91, THE GLOVES WERE BROWN AND DETERIORATED. THIS IS THE ONLY TIME THIS HAS HAPPENED, BUT THIS IS A CONCERN TO RPTR.
TIP OF BLADE PROTRUDES THROUGH THE PLASTIC-SEALED PACKAGES. THEREFORE, STERILITY IS DESTROYED PRIOR TO USE.
RPTR HAD BILATERAL AUGMENTATION MAMMOPLASTY ON 10/20/86; SILICONE GEL IMPLANTS WERE USED. ON 10/23/86 SHE HAD AN EVACUATION OF A HEMATOMA WHICH FORMED IN THE RIGHT BREAST. APPROX 500 CC'S OF CLOTTED BLOOD WAS REMOVED AND IMPLANT REINSERTED AS STATED IN SURGEON'S OPERATIVE REPORT. SHE UNDERWENT TWO SUBSEQUENT SURGERIES ON THE RIGHT BREAST: AN OPEN CAPSULAR RELEASE ON 4/15/87, (AT WHICH TIME THE IMPLANT RUPTURED UPON INSPECTION BY THE SURGEON), AND EVACUATION OF A HEMATOMA ON 4/18/87. SHE HAS HAD SEVERE INFLAMMATION AND JOINT PAIN IN VARIOUS BODY JOINTS AND WAS DIAGNOSED WITH RHEUMATOID ARTHRITIS IN MARCH OF 1988. RPTR DOES NOT KNOW WHAT BECAME OF RUPTURED IMPLANT.
DURING A SURGICAL PROCEDURE, A PIECE OF WOOD APPROX 3" LONG AND 3/4" WIDE WAS FOUND WITH A 4 X 4", 16 PLY SPONGE. THE SPONGE WITH THE WOOD WAS FULL OF BLOOD AND WAS DISCARDED. MFR HAS BEEN CONTACTED FOR AN EXCHANGE.
WHEN THE ANTIBIOTIC WAS HUNG, THE NURSE NOTED PRECIPITATION STARTING IN THE IV PUMP WHERE THE TWO SOLUTIONS CAME TOGETHER. SHE TURNED THE PUMP OFF BEFORE THE PRECIPITATE REACHED THE PT. SHE CHANGED THE IV SITE AND THE TUBING, NOTICING THAT THE NEEDLE WAS CLOGGED. SHE STARTED THE DRIP AGAIN IN THE OTHER ARM. IT IMMEDIATELY PRECIPITATED. SHE DREW SOME OF EACH SOLUTION INTO A SYRINGE. THERE WAS NO PRECIPITATION. THESE TWO SOLUTIONS HAD PREVIOUSLY BEEN ADMINISTERED TOGETHER WITHOUT A PROBLEM, USING THE SAME PUMP AND BRAND OF TUBING.
PT HURT HIS BACK IN 1993. PT WENT TO A LOCAL DR AND HE SAID PT AHD A HERNIATED DISC. PT WENT TO SEE ANOTHER DR WHO IMPLANTED A METAL SCREW IN PT'S LOWER BACK. PT NOT SATISFIED WITH THE PROCEDURE.
YAG LASER FIBER BROKE OFF INSIDE BLADDER. RETRIEVED WITH NO NEGATIVE OUTCOME.
TPN FLUID WAS HUNG AND RUNNING ON PT. A PIECE OF MATTER RESEMBLING AN INSECT OR TWIG WAS OBSERVED IN THE TUBING BY A FAMILY MEMBER. THE TPN SOLUTION WAS PREPARED USING MFR'S FLUIDS AND ANOTHER MFR'S TUBING WAS USED TO ADMINISTER THE FLUID. HOWEVER, THE TPN HAD BEEN RUNNING FOR AWHILE, SO THE FLUID ITSELF IS SUSPECT. PIECE OF TUBING CONTAINING THE PARTICLE HAS BEEN KEPT. ALL OTHER PARTS WERE DISCARDED. (ALSO SEE 1008696, 1008697, 1008698).
WHILE RPTR WAS RELAXING IN TUB (PUMP WAS NOT WET OR IN TUB; WATERPROOF CAP WAS IN) SHE HEARD THE PUMP START GRINDING LOUDLY. SHE LOOKED AT THE SCREEN; IT WAS BLANK. SHE TRIED TO COMMAND PUMP OFF BY PRESSING PROPER BUTTONS, IT WOULDN'T TAKE COMMANDS - IT WAS APPARENTLY SHORTED OUT. SHE SCREAMED FOR HER HUSBAND TO HELP. HE RAN IN. SHE FELT INSULIN AT INFUSION SITE BURNING AS IT WAS BEING FORCED INTO HER. SHE YANKED OUT INFUSION SET. THE PUMP WAS EMPTYING INSULIN CARTRIDGE. HER HUSBAND COULD NOT GET THE PUMP TO SHUT OFF/QUIT GRINDING UNTIL HE FINALLY REMOVED THE BATTERIES. SHE HAD A MAJOR OVERDOSE OF INSULIN. SHE HAD NO IDEA HOW MUCH. HAD THIS HAPPENED IN HER SLEEP SHE IS SURE SHE WOULD BE DEAD. SHE WOULD NOT HAVE HEARD THE GRINDING SOUND. THE D/C MOTOR SHORTED OUT, APPARENTLY. MFR HAS IGNORED ALL HER QUESTIONS REGARDING THIS MATTER. WITHIN 15 MINUTES HER BLOOD SUGAR WAS IN THE 40'S. IT TOOK LOTS OF FAST-ACTING, GLUCOSE TABLETS AS WELL AS A MEAL AND SWEETENED DRINKS TO RETURN TO NORMAL. SHE SENT MFR HER EXACT BLOOD SUGARS WHEN SHE RETURNED THE PUMP.
TPN FLUID WAS HUNG AND RUNNING ON PT. A PIECE OF MATTER RESEMBLING AN INSECT OR TWIG OBSERVED IN THE TUBING BY A FAMILY MEMBER. THE TPN SOLUTION WAS PREPARED USING CLINTEC FLUIDS AND AUTO-MIX. TUBING WAS USED TO ADMINISTER THE FLUID. HOWEVER, THE TPN HAD BEEN RUNNING FOR A WHILE SO THE FLUID ITSELF IS SUSPECT. PIECE OF TUBING CONTAINING THE PARTICLE HAS BEEN KEPT. ALL OTHER PARTS WERE DISCARDED. (ALSO SEE 1008693, 1008697, 1008698).
TPN FLUID WAS HUNG AND RUNNING ON PT. A PIECE OF MATTER RESEMBLING AN INSECT OR TWIG OBSERVED IN THE TUBING BY A FAMILY MEMBER. TUBING WAS USED TO ADMINISTER THE FLUID. HOWEVER, THE TPN HAD BEEN RUNNING FOR A WHILE SO THE FLUID ITSELF IS SUSPECT. PIECE OF TUBING CONTAINING THE PARTICLE HAS BEEN KEPT. ALL OTHER PARTS WERE DISCARDED. (ALSO SEE 1008693, 1008696, 1008698).
TPN FLUID WAS HUNG AND RUNNING ON PT. A PIECE OF MATTER RESEMBLING AN INSECT OR TWIG OBSERVED IN THE TUBING BY A FAMILY MEMBER. THE TPN SOLUTION WAS PREPARED USING ANOTHER MFR'S FLUID AND COMPOUNDER. MFR'S TUBING WAS USED TO ADMINISTER THE FLUID. HOWEVER, THE TPN HAD BEEN RUNNING FOR A WHILE SO THE FLUID ITSELF IS SUSPECT. PIECE OF TUBING CONTAINING THE PARTICLE HAS BEEN KEPT. ALL OTHER PARTS WERE DISCARDED. (ALSO SEE 1008693, 1008696, 1008697).
PT WAS ADMITTED TO HOSP ON 2/14/96 FOR AN INTRACRANIAL HEMORRHAGE AND HAD A VENTRICULOSTOMY TUBE PLACED. NURSE ADMINISTERED KEFZOL AT APPROX 6:20 AM ON 2/18/96, WHICH WAS ORDERED AS A PROPHYLACTIC ANTIBIOTIC. INSTEAD OF ADMINISTERING THE KEFZOL INTRAVENOUSLY, AS ORDERED, THE NURSE INJECTED THE KEFZOL INTO THE VENTRICULOSTOMY TUBING. AT 7:00 AM, THE DAY SHIFT BEGAN. THE CHARGE NURSE FOR THE NIGHT SHIFT AND THE PRIMARY NURSE FOR THIS PT ADVISED THE DAY SHIFT CHARGE NURSE THAT SHE HAD BEEN EXPERIENCING NAUSEA AND VOMITING. AT APPROX 7:05 AM, A NURSE ENTERED THE PT'S ROOM TO ADMINISTER THE ANTI-EMETIC MEDICATION AS ORDERED, ONDANCETRON. AT THAT TIME, IT WAS DISCOVERED THAT THE PIGGYBACK IV LINE HAD BEEN CONNECTED TO THE VENTRICULOSTOMY TUBING. THIS WAS CORRECTED AND THE ONDANCETRON WAS ADMINISTERED THROUGH THE PERIPHERAL LINE. DR OF NEUROSURGERY, WAS NOTIFIED OF THE INCIDENT IMMEDIATELY. THE PT CONTINUED TO COMPLAIN OF NAUSEA AND HEADACHE, BUT THE EMESIS STOPPED. THE PT DISPLAYED ANXIETY AND WAS SHAKING. ATIVAN 1 MG IV WAS ADMINISTERED AT 7:45 AM. THE PT PROCEEDED TO BECOME MORE ANXIOUS AND STARTED TO HALLUCINATE. HALDOL .25 MG IM WAS GIVEN AT 8:55 AM. AT THIS TIME, DR ENTERED THE ROOM AND ORDERED THE PT TO BE TRANSFERRED TO THE SICU FOR CLOSER OBSERVATION. THE PT CONTINUED WITH HALLUCINATIONS AND SCREAMING ALOUD. PRIOR TO THE PT LEAVING FOR THE SICU, ATIVAN 2 MG IV WAS ADMINISTERED AT 9:30. DILANTIN 500 MG IV WAS ORDERED AND STARTED ON THE PT AT 9:45 AM, IMMEDIATELY PRIOR TO PT LEAVING UNIT 65. JUST BEFORE REACHING THE SICU, THE PT CODED AND WAS ASYSTOLIC FOR APPROXIMATELY 10 MINUTES. LIFE SUPPORT WAS BEGUN; HOWEVER, SUBSEQUENT SCAN FINDINGS MET THE CRITERIA FOR BRAIN DEATH. LIFE SUPPORT WAS TERMINATED AND THE PT EXPIRED 2/19/96 AT APPROXIMATELY 8:00 PM.
PT WAS FOUND WITH NO APPARENT PULSE OR RESPIRATIONS AT 7:15 AM. PT APPEARED TO HAVE BEEN ATTEMPTING TO CLIMB OUT OF BED. SIDE RAILS ON BED WERE LOCKED IN UP POSITION. PT'S LEFT ARM AND HEAD WERE STUCK BETWEEN THE SIDERAILS. HIS BODY AND PILLOW WERE ON THE FLOOR. PT WAS LOWERED TO FLOOR. THERE WAS NO VISIBLE TRAUMA TO THE NECK. EVENT WAS REPORTED TO POLICE. THE INVESTIGATING OFFICER STATED THAT THERE WAS NO OBVIOUS SIGN OF DEATH BEING CAUSED BY PT'S ATTEMPT TO GET OUT OF BED AND THAT THERE WOULD BE NO FURTHER POLICE INVOLVEMENT.
PT FOUND RESPONSIVE AT 0225. APNEA MONITOR WAS FLASHING THE GREEN INDICATOR LIGHT BUT WAS NOT ALARMING. DURING RESUSCITATION OF THE PT, THE GREEN LIGHT WAS ON DURING COMPRESSION AND ALARMED WHENEVER THERE WAS CESSATION OF CHEST COMPRESSION ON VENTILATION. THERAPIST REPORTED THAT APPROXIMATELY FIVE HOURS EARLIER THE LOOSE LEAD ALARM WOULD SOUND. SHE CHANGED ALL THE LEADS AND THE PROBLEM CEASED AND THE MONITOR FUNCTIONED ACCORDING TO THE MFR GUIDELINES. DURING INVESTIGATION OF THE INCIDENT, THE EQUIPMENT WAS TAKEN OUT OF SERVICE AND SUBMITTED FOR EVALUATION. THE RENTAL CO DID THE LAST PREVENTATIVE MAINTENANCE CHECK IN APRIL OF 1995. THE UNIT APPEARS TO MEET MFR'S OPERATIONAL STANDARDS. NO OPERATIONAL OR MECHANICAL PROBLEMS WERE FOUND WITH THE MONITOR EXCEPT FOR THE LOOSE SCREW AND WASHER. IT IS OBVIOUS FROM THE BATTERY DATE THAT THIS UNIT HASN'T BEEN MAINTAINED IN STRICT ACCORDANCE WITH THE MFR'S RECOMMENDATIONS. THE POSSIBILITY CANNOT BE RULED OUT AT THIS POINT THAT THE LOOSE METALLIC HARDWARE INSIDE THE CASE TEMPORARILY CAUSED A "SHORT-CIRCUIT" WHICH DEACTIVATED THE ALARM CIRCUIT. HOWEVER, UNDER A CLOSE VISUAL EXAMINATION OF THE COMPONENTS ON THE MAIN AND AUXILIARY CIRCUIT BOARDS, NO EVIDENCE OF ARCING WAS NOTED.
DURING PLACEMENT OF CATHETER, PT'S ASCENDING AORTA WAS DISSECTED. LOSS OF BP WAS NOTED. PT EXPIRED.
ON 11/26/95 STAFF MEMBER WAS IN EXAM ROOM TO HELP WITH A PROCEDURE. THE STAFF MEMBER TURNED ON THE CEILING MOUNTED SPOTLIGHT AND THE DR SAID IT WAS NOT NEEDED SO THE STAFF MEMBER TURNED OFF THE LIGHT, RAISED THE LAMP TO PREVENT THE DOCOR FROM HITTING HIS HEAD. THE LIGHT BULB BLINKED A COUPLE OF TIMES EVEN WITH THE SWITCH OFF AND THEN SPARKS AND SMOKE CAME OUT FROM AROUND THE SWITCH AREA FOR A VERY BRIEF MOMENT. THE LIGHT WAS NOT TOUCHED AGAIN AND MEDICAL MAINTENANCE WAS NOTIFIED. NO HARM OR SHOCKS OCCURRED TO THE PT OR THE MEDICAL STAFF. RPTR WAS NOTIFIED OF AN OVERHEAD EXAMINATION LIGHT THAT WAS SMOKING AND SHOOTING SPARKS. AFTER NECESSARY SAFETY MEASURES WERE TAKEN, THE LIGHT ARM AND HEAD WERE DISASSEMBLED AND THE CAUSE WAS IDENTIFIED. AT THE LOWER SECTION OF THE ARM, THE HOT WIRE HAD BEEN STRETCHED TO THE POINT OF BREAKING. THIS EXPOSED THE 120V LINE DIRECTLY TO THE METAL CASING CAUSING SPARKS AND A POTENTIALLY LIFE THREATENING SITUATION. THE UNIT WAS REMOVED FROM SERVICE. FOUR OTHER UNITS IN THE BUILDING HAVE HAD SIMILAR PROBLEMS WITH THE EXAM LIGHTS' INTENDED STOP MECHANISM NOT FUNCTIONING PROPELRY. THIS ALLOWS THE POWER CORD TO WRAP ITSELF AROUND THE BASE OF THE LIGHT, EVENTUALLY PULLING THE WIRES APART. RPTR CONTACTED THE MFR WHO SAID THEY HAVE MADE THIS SYSTEM ABOUT 17 YEARS. THE COMPLAINANTS' LIGHT IS ABOUT 6 YEARS OLD. THEY REPORTED THAT THEY HAVE HAD NO SIMILAR COMPLAINTS BUT ARE INVESTIGATING.
#3F ARTERIAL EMBOLECTOMY CATHETER BALLOON RUPTURED DURING AN "EXERCISE" PROCEDURE. 1. STEP I - BALLOON INFLATED TO 50% AND THEN DEFLATED. 2. STEP II - BALLOON INFLATED TO 75% AND THEN DEFLATED. 3. STEP III ATTEMPTING TO INFLATE BALLOON TO 100% WHEN IT RUPTURED.
THE SPIROMETER USED IN THE OFFICE GIVES MUCH DIFFERENT READINGS THAN THE SPIROMETER HOSPITALS USE. THIS EVEN THOUGH THE PT IS SEEN ONLY MINUTES LATER AT THE HOSPITAL. ALSO, THE MFR REFUSES TO SEND NECCESARY PARTS, REPLACEMENT PARTS, WHICH WOULD MAKE THE SPIROMETER WORK BETTER.
RPTR'S LEFT BREAST IMPLANT RUPTURED AND WAS REPLACED.
THE PRESENT PACKAGING OF THIS BLADE MAKES IT ALMOST IMPOSSIBLE TO PRESENT IT TO THE SURGICAL FIELD IN A STERILE FASHION. IT TAKES NUMEROUS ATTEMPTS TO GET ONE KNIFE BLADE OPENED AND FOUR TO FIVE BLADES ARE USUALLY WASTED AT ONE TIME. THE WAY THE PACKAGES ARE OPENED PRESENTS A HAZARD TO THE PT AS AN INFECTION CONTROL ISSUE AND A HAZARD TO THE NURSING STAFF BECAUSE OF THE INCREASED POSSIBILITY OF BEING STUCK OR CUT BY THE BLADE.
RIGHT GREAT TOE JOINT PROSTHESIS REMOVAL, PT HAD PAIN AND SWELLING OF FOOT, SYNOVITIS.
OPERATING ROOM PERSONNEL ARE UNABLE TO OPEN THIS ITEM, SO THAT IT REMAINS STERILE. WHEN THE PLASTIC IS OPENED THE EDGES ARE CONTAMINATED, AND THE BOWL MUST PASS OVER THIS CONTAMINATED AREA.
RN PLUGGED IN BABY WARMER BASSINET AND IT BEGAN TO SMOKE. RPTR'S BIO-MED DEPT EXAMINED AND RECREATED THE SMOKE AS WELL AS FLAME. NO INJURY.
RESIDENT WAS FOUND ON BED CHECK WITH HER HEAD STUCK BETWEEN THE BARS ON THE SIDE RAIL. RAIL HAD TO BE CUT TO FREE THE RESIDENT. A LIST OF HIGH RISK RESIDENTS IS BEING CREATED AND RPTR WILL BE PURCHASING SIDE RAIL COVERGUARDS FOR THOSE RESIDENTS. (ALSO SEE 1008701)
RESIDENT WAS FOUND ON BED CHECK WITH HER HEAD STUCK BETWEEN THE BARS ON THE SIDE RAIL. RAIL HAD TO BE CUT TO FREE THE RESIDENT. A LIST OF HIGH RISK RESIDENTS IS BEING CREATED AND RPTR WILL BE PURCHASING SIDE RAIL COVERGUARDS FOR THOSE RESIDENTS. (ALSO SEE 1008700)
TRANSPORTING PATIENT WITH ACUTE MI OR TPA, WHEN BOTH BATTERIES FAILED. SPORADIC READINGS WERE ONLY AVAILABLE WITH CONTINUED EXCHANGING OF THE BATTERIES. NO CARDIAC EVENT OCCURRED WITH THE PATIENT WHICH WOULD HAVE NECESSITATED FURTHER USE OF THE MONITOR.
PLASTIC SHARD SEEN IN DRIP CHAMBER OF IV TUBING. PARTICLE LIKELY SHEARED OFF THE INSIDE OF THE BURETTE INJECTION PORT.
RPTR ATTEMPTED TO INSERT CENTRAL PICC LINE AND WAS UNABLE TO GET INTRODUCER OUT.
RPTR COULD NOT WITHDRAW GUIDE WIRE AFTER PLACING PICC LINE.
CATHETER (60 CM 4-6 FR) FULLY SEPARATED FROM HUB. NURSE WALKED INTO ROOM AND PT WAS HOLDING LINE IN HIS HAND.
RPTR PULLED ON GUIDE WIRE TO VERIFY THAT IT WOULD COME OUT AFTER PLACEMENT. IT BUCKLED THE CATHETER. SHE PULLED AGAIN AND IT CAME OUT SEVERAL CM BUT SHE WAS UNABLE TO ADVANCE IT BACK THROUGH CATHETER, WITHOUT IT KINKING. IT WAS NOT USED ON A PT. ANOTHER PRODUCT WAS USED INSTEAD.
VALVE WAS IMPLANTED ON 1/18/96. THREE WEEKS LATER, PT DEVELOPED CONGESTIVE HEART FAILURE AND MURMUR OF AORTIC INSUFFIENCY. TRANS-ESOPHAGEAL ELECTROCARDIOGRAM & HEART CATH REVEALED SEVERE AORTIC INSUFFIENCY. VALVE WAS RE-EXPLORED ON 2/13/96 AND FOUND TO HAVE A PERFORATED LEAFLET OF VALVE. REPLACED. VALVE WILL BE RETAINED IN HOSP. IT MAY BE VIEWED BY MFR THERE. HOSP WILL NOT RELEASE AT THIS TIME.
EQUIPMENT USED TO TEST INTEGRITY OF REPLACED MITRAL VALVE. BALLOON FAILED TO DEFLATE WHICH COMPROMISED NEW VALVE. REQUIRED RE-OPENING OF ATRIUM CHAMBER OF HEART, MANUALLY DEFLATING BALLOON AND REMOVING IT. ALSO, REQUIRED COOLING THE HEART AGAIN PRIOR TO DEFLATING BALLOON.
RIGHT BREAST IMPLANT DEFLATED & RUPTURED.
FEMALE RESIDENT HAS A CO UNIT IN HER BED TO SIGNAL UNASSISTED TRANSFERS (SHE HAS UNSTEADY GAIT). UPON CLIMBING OUT OF BED, THE UNIT FAILED TO ALARM. A FALL RESULTED. PT HAD BROKEN NOSE, CHIPPED TOOTH, ABRASIONS, AND BRUISES.
PATIENT ON UNIT WITH 20 GAUGE 1 1/4" CATHETER IN RIGHT FOREARM. HUB SEPARATED FROM PLASTIC CATHETER. PLASTIC CATHETER REMAINS IN PT'S ARM. PT HAS PSYCHIATRIC HISTORY. PT MAY HAVE CUT CATHETER. WHEN CATHETER REMOVED RPTR WILL SEND TO AN INDEPENDENT TESTING ORGANIZATION FOR EXAMINATION.
SEALED 60 CC SYRINGE WAS OPENED TO BE USED. IT WAS LACKING RUBBER STOPPER INSIDE THE BARREL.
WHILE ATTEMPTING TO REMOVE THE SUPRAPUBIC CATHETER FROM PT, THE CATHETER  BROKE OFF LEAVING A PIECE INSIDE THE BLADDER. THIS HAD TO BE REMOVED VIA CYSTOSCOPY.
FLUID WOULD NOT RUN ON PUMP THROUGH THIS TUBING.
RPTR'S HOSP NO LONGER STOCKS THESE MULTIPLE POWER SURGE SUPPRESSORS. HAVE ENCOURAGED INSPECTION OF ALL MULTIPLE OUTLET POWER SURGE SUPPRESSOR THROUGHOUT THE HOSP.
INSERTION OF MULTIPLE COMPONENT PENILE PROSTHESIS. PT READMITTED ON 2/8/96, FOR REMOVAL OF DEVICE. POSSIBLE SUBACUTE BACTERIAL ENDOCARDITIS.  UROSEPSIS- SEPTICEMIA. DEVICE WAS IMPLANTED ON 1/9/96. DEVICE WAS EXPLANTED DUE TO POSSIBLE SUBACUTE BACTERIAL ENDOCARDITIS ; UROSEPSIS SEPTICEMIA.
PHYSICIAN WAS DOING CYSTOSCOPY-CALCUTRIPT OF BLADDER STONES. WHILE USING THE STONE CRUSHER ON A LARGE STONE FROM THE BLADDER, THE STONE BECAME LODGED IN THE ISTRUMENT CAUSING IT TO MALFUNCTION. THE TIPS OF THE INSTRUMENT TURNED AT A 90 DEGREE ANGLE TO EACH OTHER.
ACCORDING TO MEDICAL REPORT, RPTR HAD BILATERAL SILICONE BREAST IMPLANTS PLACED IN 1975 BECAUSE OF AGENESIS OF BREAST TISSUE. SHE STARTED DEVELOPING SOME INTERMITTENT KNEE ACHING IN 1977 BUT IT WAS NOT UNTIL ABOUT 1982 WHEN SHE STARTED HAVING SEVERE MIGRAINE HEADACHES, SHE DEVELOPED FATIGUE, HAD DIFFICULTY SLEEPING, STARTED WAKING UP STIFF AND TIRED AND DEVELOPED GELLING PHENOMENON ABOUT 10 YEARS AGO. SHE HAS DEVELOPED CHEST WALL PAIN. SHE HAS BEEN DIAGNOSED AS HAVING "ARTHRITIS." SHE HAS BEEN TO PAIN CLINICS AND IS PRESENTLY TAKING PRILOSEC, VICODEN, PHENERGAN AND PROPULSID. WHEN SHE WAS 18 YEARS OF AGE SHE WAS DIAGNOSED AS HAVING "SPASTIC COLON." SHE HAS HAD COGNITIVE DYSFUNCTION FOR THE PAST 10 TO 11 YEARS. SHE HAS HAD PROBLEMS WITH MEMORY AND CONCENTRATION. SEXUAL INTERCOURSE IS VERY PAINFUL BECAUSE OF MUSCLE SPASMS. THIS HAS PUT A STRAIN ON HER MARRIAGE. HER ACTIVITIES OF DAILY LIVING ARE SEVERELY CURTAILED. SHE CANNOT PERFORM ANY ATHLETIC EVENTS. SHE HAS TO PUSH HERSELF TO DO HOUSEWORK. SHE HAD SICCA SYMPTOMS FOR TEN YEARS WITH DRY EYES AND DRY MOUTH. SHE HAS HAD DIFFICULTY WITH SWOLLEN GLANDS IN HER NECK AND ARMPIT AREA FOR THE PAST 8 TO 10 YEARS. SHE HAS HAD POLYARTHRALGIAS AND POLYMYALGIAS FOR ABOUT THE PAST 10 YEARS ROUGHLY. THERE ARE 18 OF 18 FIBROMYALGIA TENDER POINTS WITH ABNORMAL DOLORIMETRY. SHE HAS A RASH IN THE V AREA OF THE NECK. IT IS MACULAR AND IT BLANCHES. SHE HAS SWOLLEN LYMPH NODES. SHE HAS COSTOCHONDRAL JOINT TENDERNESS FROM THE 2ND TO THE 4TH BILATERALLY. SHE HAS A ERTICULAR SKIN DISCOLORATION OF HER ARMS AND LEGS WITH OBVIOUS RAYNAUD'S PHENOMENON WITH PURPLISH DISCOLORATION OF THE HANDS AND FEET WITH COLD FEELING OF THE HANDS AND FEET. THERE IS ENCAPSULATION OF THE LEFT BREAST IMPLANT. THE LEFT BREAST IS SLIGHTLY SMALLER THAN THE RIGHT BUT THE DEGREES ON THE RIGHT AND 15 DEGREES ON THE LEFT. THERE IS SWELLING OF THE RIGHT KNEE. THERE IS PAIN ON PATELLA COMPRESSION OF THE RIGHT KNEE BUT NOT THE LEFT. THERE IS POSITIVE STRAIGHT LEG RAISING ON THE RIGHT AT 45 DEGREES. SHE HAS A TRIGGER POINT IN THE BILATERAL GLUTEUS MEDIUS AREA. BASED IN CAREFUL HISTORY AND THOROUGH PHYSICAL EXAMINATION, IT IS THE DOCTOR'S PROFESSIONAL OPINION THAT THIS PT SUFFERS FROM ATYPICAL CONNECTIVE TISSUE DISEASE/ATYPICAL RHEUMATIC SYNDROME/ONSPECIFIC AUTOIMMUNE CONDITION. SHE HAS IMMUNE MEDIATED SKIN CHANGES, PERIPHERAL NEUROPATHY, ENTRAPMENT NEUROPATHIES, ARTHRALGIAS, MYALGIAS, CHRONIC FATIGUE (>6 MONTHS). IMPLANTED 5/75.
DISTAL PORTION OF TRIAL STEM BROKE, SEPARATING FROM PROXIMAL PORTION. WINDOW WAS MADE IN FEMUR FOLLOWED BY SEVERAL HOLES DRILLED IN THE TRIAL STEM. BONE PUNCH WAS USED THROUGH THESE DRILL HOLES TO FACILITATE MOVEMENT OF THE BROKEN PORTION. BROKEN STEM WAS REMOVED. PT IS DOING GOOD. DEVICE WAS SENT FOR EVALUATION.
PT HAD LEAKING RIGHT BREAST IMPLANT. IT WAS REMOVED AND REPLACED.
PT WAS RECEIVING TPN AND LIPIDS THROUGH THE STOPCOCK. NURSE FOUND STOPCOCK WAS LEAKING AND THE PT HAD APPROX. 12 CC BLOOD LOSS. HGB HAD DROPPED AND THE PT RECEIVED 30 CC OF PACKED RED BLOOD CELLS.
FACILITY ALLEGES BLOOD LEAK DURING DIALYSIS.  RN REPORTS LEAK OCCURRED 10 MINUTES INTO TREATMENT.  VERIFIES WITH HEMORTIFIER.  TREATMENT RESTARTED WITH NEW DIALYZER.  NO FURTHER PROBLEMS REPORTED.  ESTIMATED BLOOD LOSS >100CC.  REUSE #8.
RPTR HAD 225CC SILICONE BREAST IMPLANTS PLACED 4/77. CALCIUM OCCURRED IN HER LEFT BREAST. A MEDICAL PROFESSIONAL HAS CONFIRMED SILICONE OUTSIDE THE BREAST, SCAR TISSUE CAPSULE. SHE HAD NUMBNESS IN THE SURGICAL AREA. IMPLANTS WERE RUPTURED, SHE HAD BLEEDING THROUGH THE ENVELOPE, ONE CAPSULAR CONTRACTURE AND ONE CLOSED CAPSULOTOMY. SHE C/O: BLOOD PRESSURE PROBLEMS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES, CHEST/RIB CAGE, PAIN AND/OR BURNING SENSATION, ELEVATED CHOLESTEROL OR TRIGLYCERIDES, RAPID EYE DETERIORATION, CHRONIC SWELLING, PAIN AND HEAT OR COLD SENSITIVITY OF EXTREMITIES, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, "FLOODING/CLOTTING" PERIODS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, FREQUENT MIGRAINES/SEVERE HEADACHES, MITRAL VALVE PROLAPSE, CONNECTIVE TISSUE DISEASE, LUPUS, ATYPICAL LUPUS, INFLAMMATION, SWELLING, PAIN/ARTHRALIGA AND PERSISTENT STIFFNESS, MUSCLE PAIN & BURNING, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPS THINGS, MISJUDGES DISTANCE/RUNS INTO OBJECTS.
CATHETER WAS INSERTED ON 2/12. THE PT WAS IMPROVING AND THE PHYSICIAN D/C THE CATHETER. DURING THE REMOVAL OF THE CATHETER, THE BALLOON WAS REMOVED IN PIECES.
A 4 MONTH OLD INFANT WHO WAS UNDERGOING VP SHUNT REVISION, DEVELOPED PO2 OF 18 AND SUFFERED CARDIAC ARREST. RESUSCITATED BUT BELIEVED TO HAVE LIKELY SUSTAINED FURTHER BRAIN DAMAGE. VENTILATOR AND/OR BLENDER MALFUNCTION SUSPECTED. ECRI INSPECTION OF BLENDER REVEALED BLUE NITROUS OXIDE HOSE FITTED TO OXYGEN PORT OF BLENDER BY MFR SO THAT NITROUS OXIDE WAS DELIVERED WHEN ADMINISTRATION OF OXYGEN WAS INTENDED.
PT DEVELOPED DISSECTION OF RCA DURING REPEAT PTCA OF RCA.  ATTEMPTED TO DEPLOY A 3.5 MM GIANTURCO-ROUBIN FLEX STENT USING A 100CM GUIDING CATHETER TO REPAIR DISSECTION.  STENT DID NOT DEPLOY PROPERLY--CATHETER SECURED AND PT SENT FOR CABG.  UNABLE TO LOCATE STENT DURING CABG.  VISUALIZED STENT IN R. ILLIO FEMEROL ARTERY ON 9/13/94.  POTENTIAL PROBLEM WITH GUIDING CATHETER.  PT WAS STABLE THE NEXT MORNING FOLLOWING BYPASS.
PT RECEIVED INCORRECT AMOUNT OF MORPHINE MOST LIKELY RELATED TO USER ERROR RESULTING IN OVERNIGHT ICU OBSERVATION WITH NO PERMANENT INJURY.
A #18 FRENCH FOLEY CATH WOULD NOT DEFLATE BY USUAL METHODS. THEREFORE, IT WAS REMOVED SURGICALLY POSSIBLY RELATED TO PT ANATOMY.
HYGROSCOPIC CONDENSER HUMIDIFIER (HCH). THE LAST 2 TO 3 CASES OF THIS PRODUCT HAVE HAD "CRACKED" HCH'S. THE CRACK IS COMPLETELY THROUGH THE MASK PORT, CAUSING THE SYSTEM TO HAVE A SEVERE LEAK. ALL HCH'S WERE DISCOVERED PRIOR TO USE DURING PREOPERATIVE CHECK OF ANESTHESIA MACHINE AND EQUIPMENT. CO NOTIFIED 3/8/96.
LAVH WAS BEING PERFORMED. DR WAS USING A DEVICE TO CUT AND STAPLE THE OVARY AND TUBE. UPON THE INITIAL FIRING OF THE INSTRUMENT, COMPLETE HEMOSTASIS WAS NOT OBTAINED. THEREFORE, THE INSTRUMENT WAS REMOVED AND RELOADED WITH A WHITE STAPLE. THE INSTRUMENT WAS FIRED FOR THE SECOND TIME AND AT THAT TIME THE INSTRUMENT WOULD NOT RELEASE.
PT HAD SALINE IMPLANTS PLACED IN 1971 AND HAS A DISABILITY.
WHILE MOVING A PT ON THE BED, A NURSE DEPRESSED THE FOOT PEDAL ON THE LOCK/STEER MECHANISM TO PUT THE WHEELS IN THE NEUTRAL POSITION. AFTER ACTIVATING, SHE NOTICED THE BACK WHEEL WAS STILL LOCKED IN THE STEER POSITION MAKING IT HARD TO MANEUVER THROUGH THE DOORS OF THE ROOM. A PLASTIC CAM, WHICH IS CONNECTED TO THE FOOT PEDAL, BROKE. THIS AREA, IN WHICH THE CAM IS PLACED, IS A HIGH STRESS AREA. THIS CAM SHOULD BE MADE OF A MORE DURABLE MATERIAL. SAME OCCURRENCE 11/30/94 ON THE OPPOSITE SIDE.
APPARENT BURRS ON NEEDLE TIP CAUSED JAGGED PUNCTURES IN PTS' SKIN. PTS C/O INCREASED PAIN. THIS PROBLEM APPEARS INTERMITTENTLY WITH DIFFERENT SHIPMENTS OF THIS PRODUCT.
PT WAS IMPLANTED 1987. ONE CYLINDER ERODED IN 1988 AND PT HAS BEEN FUNCTIONING WITH ONLY ONE CYLINDER. IN 11/94 HE HEARD A SNAP DURING COITUS AND PROSTHESIS LOST RIGIDITY. IT WAS EXPLANTED.
THE CUSTOMER REPORTED THE COLOR CHANGE OF THE PRODUCT IS NOT AS NOTICEABLE AS ANOTHER MFR'S BRAND. NO PT INJURY WAS REPORTED.
IT WAS REPORTED THAT A YOUNG FEMALE RECEIVED AN ANESTHETIC FOR A CYSTOSCOPY PROCEDURE ON 12/1/94. LIDOCAINE GEL WAS NOT USED ON THE MASK FOR LUBRICATION DURING INSERTION. FOLLOWING THE PROCEDURE THE PT COMPLAINED OF A SLIGHT SORE THROAT. SHE WAS DISCHARGED THAT AFTERNOON. THE PT REPORTED HER SORE THROAT WORSENED TO THE POINT AT WHICH SHE COULD NOT SWALLOW. AN ENT SPECIALIST FOUND PHARYNGEAL ULCERATIONS AND STARTED THE PT ON STEROIDS AND ANTIBIOTICS. THE PT DID NOT REQUIRE ADMISSION TO THE HOSP. THE EVENT WAS ATTRIBUTED TO THE USE OF A CHEMICAL OR STERILIZATION AGENT.
A MEDICAL TECHNOLOGIST REPORTED THAT A PT, WITH A HISTORY OF END-STAGE CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HAS BEEN TAKING COUMADIN BECAUSE OF A MECHANICAL AORTIC VALVE. PROTIMES (PROTHROMBIN TIMES, PTS) HAVE BEEN FLUCTUATING SINCE 8/94 AND WERE THEREFORE BEING MONITORED FREQUENTLY. THE PHYSICIAN FELT THAT THE PT WAS EXPERIENCING DRUG INTERACTIONS BECAUSE OF THE NUMBER OF MEDICATIONS HE WAS RECEIVING. ON 12/15/94, ON A COUMADIN REGIMEN OF 7.5 MG QD, THE RPTR NOTED THAT THE PT HAD BRUISES ALL OVER HIS ARMS. PT ON THE TEST SYSTEM MONITOR WAS 16.5 SECONDS. THE PHYSICIAN QUESTIONED THE RESULTS, AND THE TEST WAS REPEATED THREE MORE TIMES. RESULTS WERE 39, 14, AND 15 SECONDS. A SPECIMEN WAS SENT TO AN OUTSIDE LAB WHERE PT WAS REPORTED AS 48.4 SECONDS. THE RPTR'S SUPERVISOR INDICATED THAT SHE HAD CONFIDENCE IN THE MONITOR. COUMADIN WAS HELD ON 16- AND 17-DEC-94 AND WAS RESUMED AT 5 MG QD ON 18-DEC-94. A SECOND MONITOR WAS SENT TO THE PHYSICIAN'S OFFICE. ON 12/19/94, PT WAS 16 SECONDS ON THE ORIGINAL MONITOR, 27.2 SECONDS ON THE SECOND MONITOR, AND 23 SECONDS ACCORDING TO THE OUTSIDE LAB.
A NURSE REPORTED THAT A PT, WHO WAS TAKING COUMADIN FOR A CLOT IN THE LEG, HAD A PT (PROTHROMBIN TIME) OF 14 SECONDS USING A TEST SYSTEM IN THE PHYSICIAN'S OFFICE. AS A RESULT, THE PHYSICIAN INCREASED THE PT'S COUMADIN DOSAGE. THE PT WAS SUBSEQUENTLY ADMITTED TO THE HOSP WITH A BLOODY NOSE. ON ADMISSION, PT WAS 37 SECONDS. THE NURSE STATED THAT THE ELECTRONIC CONTROLS WERE INTACT. RESULTS ON WHOLE BLOOD CONTROLS AND DESCRIPTION OF TECHNIQUE WERE NOT PROVIDED. THE MONITOR WAS RETURNED TO THE MFR FOR EVALUATION.
LASER TIP DISLODGED FROM LASER PROBE DURING PROCEDURE.
PHYSICIAN WAS PLACING ARTERIAL LINE IN LEFT FEMORAL AREA. WIRE WOULD NOT THREAD. WHEN PULLING OUT WIRE IT UNCOILED AND A SPLINTER OF WIRE WAS RETAINED IN THE FEMORAL TRIANGLE.
PT UNDERWENT DIAGNOSTIC LAPAROSCOPY. DURING INSERTION, THE RIGHT COMMON ILLIAC ARTERY WAS PUNCTURED. THE VESSEL WAS REPAIRED. PT WAS HOSPITALIZED FOR 5 DAYS. PT WAS RELEASED AND IS DOING WELL.
PT HAD BILATERAL CAPSULAR CONTRACTURE WITH RUPTURED SILICONE IMPLANTS. FEMALE PT'S DOB IS 8/20/58 AND WEIGHS 112 LBS.
BLOOD WAS NOTED IN INTRA-AORTIC BALLOON PUMP. DECISION MADE TO REMOVE CATHETER. CATHETER WAS REMOVED INTACT BY PHYSICIAN. DIAGONAL TEAR NOTED APPROX 1/4" IN TIP OF BALLOON. NO ADVERSE OUTCOME IN PT.
AT CONCLUSION OF A CARDIAC SURGERY PROCEDURE, SURGEON ATTEMPTED DEFIBRILLATION VIA SYNC CONTROL FROM A PT MONITOR. ON FIRST ATTEMPT, SYNC PULSE FAILED. SECOND ATTEMPT WAS SUCCESSFUL.
PT CAME IN TO THE SURGERY CTR TO HAVE HER ORIGINAL BREAST IMPLANTS REMOVED. ORIGINALLY IMPLANTED ON 3/15/79. BOTH IMPLANTS HAD RUPTURED.
ONE HOUR AND FORTY FIVE MINUTES INTO AN UNEVENTFUL HEMODIALYSIS TREATMENT, THIS PT EXPERIENCED A CARDIAC ARREST. CPR WAS INITIATED AND THE PT WAS TRANSPORTED TO THE HOSP WHERE HE EXPIRED. THE PT DIALYZED ON A POTASSIUM FREE BATH. HIS POTASSIUM ON 315 WAS 6.0. THE DIALYSIS MACHINE WAS REMOVED FROM USE AND INSPECTED BY THE SVC TECH.
THE DOOR LATCH ON A AUTOCLAVE MALFUNCTIONED, CAUSING THE DOOR TO OPEN APPROX 1/4 INCH, RELEASING STEAM AND WATER. THERE WERE NO INJURIES CAUSED BY THIS MALFUNCTION. THE MALFUNCTION WAS CAUSED BY CRACKING OF THE BEARING ASSEMBLY DUE TO OVERTIGHTENING OF THE DOOR. CO HAS HAD ONLY ONE OTHER REPORT OF AN INCIDENT SIMILAR TO THIS OUT OF THE THOUSANDS OF UNITS SOLD. IN BOTH CASES, THE SAFETY LATCH FUNCTIONED PROPERY PREVENTING THE DOOR FROM OPENING MORE THAN 1/4 INCH.
SURGEON REQUESTED A LONGER COMPONENT FOR REPLACEMENT OF A SIZE SMALL ULNA COMPONENT. AT INSERTION, DEVICE WAS FOUND TO BE A SIZE REGULAR LONG ULNA COMPONENT WHICH WAS TOO LARGE TO MATE WITH THE SIZE SMALL HUMERAL COMPONENT. THE SURGEON MODIFIED THE COMPONENT WHICH EXTENDED OPERATIVE TIME.
STEM EXTENSION BROKE OFF AT THREADS. TIBIAL PLATE AND TIBIAL ARTICULAR SURFACE WERE ALSO REMOVED.
RPTR HAS AN ISSUE REGARDING A MEDICAL DEVICE THAT WAS USED IN AN OPERATION FOR DETACHED RETINAS. HE HAD BEEN OPERATED ON IN 1982 FOR A LEFT-EYE DETACHED RETINA AND THEN AGAIN IN 1985 FOR A RIGHT-EYE DETACHED RETINA. THE LATTER OPERATION HAD PROVEN TO BE SUCCESSFUL UNTIL ABOUT THREE YEARS AGO. RPTR UNDERSTANDS FROM A RECENT DIAGNOSIS THAT THE PLASTIC "BUCKEL MATERIAL" HAS DETERIORATED, BROKEN APART AND TURNED BRITTLE, WHEN IT WAS SUPPOSED TO REMAIN FLEXIBLE AS A SPONGE AND HAS SHIFTED IN PARTS FROM ITS ORIGINAL POSITION. THIS, OF COURSE, IS A FAILURE OF THE MEDICAL DEVICE WHICH WAS REPRESENTED TO RPTR TO BE A MORE PERMANENT DEVICE. THE LEFT-EYE "BUCKEL MATERIAL," FROM THE OLDER OPERATION REMAINS INTACT. IT IS RPTR'S CONCERN TO FIND OUT IF THE PROPER MATERIAL WAS FDA APPROVED. RPTR HAS SUMMONED HOSP RECORDS OF OPERATIVE NOTES, ETC TO DETERMINE WHAT MATERIAL WAS USED, OR "SUPPOSED" TO BE USED. ACCORDING TO THE DOCTOR WHO PERFORMED THE SURGERY, THE MATERIAL USED WAS OF A POLY-ETHYLENE OR SILICONE MATERIAL AND WAS EXPLAINED TO PT TO BE WHITE WHEN IT WAS ORIGINALLY INSERTED AND HAS NOW TURNED GREY AND HAS DECOMPOSED. THIS PROBLEM HAS RENDERED RPTR DISABLED FROM HIS REGULAR EMPLOYMENT FUNCTIONS AS HE HAS A SEVERE CASE OF CONTINUOUS VERTIGO FROM THE DOUBLE IMAGES WHICH HE UNDERSTANDS HAS BEEN CAUSED BY INTERFERENCE WITH HIS EYE MUSCLES. HE FURTHER UNDERSTANDS THAT AN OPERATION TO CORRECT THIS CONDITION IS OF HIGH RISK FOR BLINDNESS.
COMPLAINANT STATED COMPANY IS USING MEDICAL UV LAMPS IN THEIR BOOTH AND SOME CUSTOMERS HAVE REPORTED RECEIVING BURNS FROM THAT FACILITY. THOSE BOOTHS ARE ALSO NOT COMMERCIAL PRODUCTS BUT WERE MFG BY THE OWNER AND MOST LIKELY NOT CERTIFIED. COMPLAINANT ALSO STATED THAT THE TANNING FACILITIES HAVE SCRAPED OFF THE MEDICAL USE ONLY LABELING ON THE LAMPS SO THAT FDA WOULD NOT REQUIRE THEM TO REMOVE THE HAZARDOUS LAMPS. THE TANNING BOOTHS WERE ALSO HOME-MADE AND THEREFORE WERE NOT LIKELY CERTIFIED TO COMPLY WITH THE FEDERAL PERFORMANCE STANDARDS.
COMPLAINANT STATED STRIPS HAVE BEEN GIVING INACCURATE READINGS FOR OVER A YEAR. COMPLAINANT TOOK THE MACHINE TO THE DOCTOR TO HAVE TESTED TO VERIFY THE ACCURACY OF THE STRIPS. COMPLAINANT HAS BEEN CHANGING INSULIN ACCORDING TO WRONG READING.
COMPLAINANT'S SON SUFFERED A COMPOUND FRACTURE OF HIS ARM IN 1993. THE DOCTOR IMPLANTED THESE BONE FIXATION DEVICES INTO HIS ARM ON 2/18/93. WITHIN 7-10 DAYS HIS HAND AND ARM BECAME SWOLLEN. EVENTUALLY THE SWELLING SPREAD TO HIS LEGS AND TORSO. HE HAS BEEN SUFFERING FROM THIS REACTION FOR THE PAST 2 YEARS. HE HAD BEEN TREATED WITH PREDNISONE WHICH ELIMINATED THE PROBLEM; HOWEVER ONCE TAKEN OFF THE PREDNISONE HE EXPERIENCED THE SWELLING AGAIN. COMPLAINANT WAS VERY UPSET THAT HER SON'S MEDICAL CONDITION HAS GONE ON FOR SUCH A LONG TIME. APPARENTLY, DR INDICATED HE WOULD TAKE THE PLATES OUT, BUT HAS BEEN POSTPONING THE SURGERY. THE DR REPORTEDLY DOES NOT BELIEVE PT IS HAVING AN ALLERGIC REACTION.
COMPLAINANT STATED IMPLANTED DEVICE HAS DETERIORATED PORTION OF HER CHEEK BONE. SHE STATED THAT APPROXIMATELY 3 YEARS AGO SHE DEVELOPED FACIAL PAIN AND SWELLING IN THE CHEEK WHERE THE DEVICE HAD BEEN IMPLANTED. APPROXIMATELY 2 MONTHS AGO AN INFECTION CAME THROUGH THE SKIN ON THE L SIDE AT THE CHEEK BONE. THE IMPLANTS WERE REMOVED APPROXIMATELY 2 WEEKS AGO AND IT WAS FOUND THAT THE IMPLANTS HAD DETERIORATED PART OF THE CHEEK BONE.
THE MOTHER OF A SIX-YEAR-OLD PT WITH A PIC LINE CALLED AT 0400 1/7/96, HYSTERICAL BECAUSE SHE HAD REMOVED THE TUBING FROM THE NEEDLELESS CONNECTOR AND THE CHILD WAS ACTIVELY BLEEDING FROM THE PIC CATHETER. THE CENTER PORTION OF THE CONNECTOR HAD NOT POPPED BACK INTO PLACE AND THEREFORE THE LINE WAS OPEN AND BLEEDING. RPTR'S COMPANY CONVERTED TO THE NEEDLE-FREE INJECTION SITE ABOUT TWO MONTHS AGO AND EXPERIENCED NO PROBLEMS WITH THE PRODUCT. THERE WAS MUCH POSITIVE FEEDBACK FROM THE PATIENTS REGARDING THIS PRODUCT. ON THE WEEK-END OF 1/6/96 RPTR BEGAN RECEIVING CALLS ABOUT THE CONNECTOR MALFUNCTIONING OR INFUSIONS NOT RUNNING IN AT THE PRESCRIBED TIMES. UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT ALL THE PROBLEMS WERE ENCOUNTERED WITH PATIENTS THAT WERE USING ANOTHER MFR'S INFUSOR. AFTER MULTIPLE CALLS TO THE DISTRIBUTOR AND THE MFR IT WAS DETERMINED THAT THERE HAD BEEN A REDESIGN IN THE INTERNAL COMPONENT (SPIKE) OF THE CONNECTOR TO WHICH SOME LUER LOCK MALE CONNECTORS ARE NOT COMPATIBLE. RPTR'S PRIMARY CONCERN IS THAT THERE HAS BEEN NO NOTIFICATION OF THIS PRODUCT CHANGE OR THE RESULTANT TUBING INCOMPATIBILITIES. WHEN MFR WAS FURTHER QUESTIONED AS TO WHY RPTR HAD NOT BEEN ALERTED TO THIS POTENTIAL PROBLEM RPTR WAS INFORMED THAT A PRODUCT SAFETY NOTICE HAD BEEN SENT TO THE DISTRIBUTOR. RPTR ASKED FOR A COPY OF THIS LETTER AND DISCOVERED THAT THE NOTICE WAS DATED 12/5/95. IN ADDITION TO BEING A COSTLY MISHAP IN TERMS OF STAFF TIME AND SUPPLY CHANGES, MOST IMPORTANTLY, PATIENTS WERE PUT AT RISK DUE TO THE CONNECTOR NOT WORKING PROPERLY. (*)
VENTILATOR PRESSURE LINE DEVELOPED EXCESSIVE WATER CONDENSATION. THE RESPIRATION RATE OF THE VENTILATOR INCREASED TO A RATE GREATER THAN THE VENTILATOR IS SET FOR. PT'S ARTERIAL BLOOD GASES WERE ABNORMAL. THE RESPIRATORY TECHNICIAN CHANGED VENTILATORS AND PT'S BLOOD GASSES RETURNED TO NORMAL. VENTILATOR SENT TO BIOMED FOR EVALUATION. VENTILATOR PULLED FROM SERVICE AND IS AWAITING EVALUATION IN BIOMED SHOP. RESPIRATORY TECHNICIAN STATES THAT THIS IS THE SECOND TIME THAT THIS PARTICULAR VENTILATOR HAS DEVELOPED EXCESS CONDENSATION IN THE PRESSURE LINE AND CYCLED FASTER THAN THE RATE IT WAS SET FOR.
INFUSION PUMP BEING UTILIZED TO ADMINISTER PITOCIN, INEXPLICABLY ADJUSTED RATE OF DELIVERY OF MEDICATION SO THAT 1683 ML WAS DELIVERED BETWEEN APPROXIMATELY 0830-1030 AM. NO HARM TO PT. POTENTIAL FOR HARM IS SIGNIFICANT.
ARTERIAL LINE FILTER INSTALLED WITHIN CARDIOPULMONARY BYPASS PUMP CIRCUIT BECAME OCCLUDED DURING BYPASS.
ON 3/6/96 RPTR RECEIVED THE SURVEY RESULTS AND RE-RAN THE SURVEY SPECIMENS ON THE DEVICE AND A SECOND ANALYZER. RPTR FOUND NO CORRELATION BETWEEN THE TWO RESULTS. RPTR CALLED THE MFR AND THE SERVICE ENGINEER CAME ON 3/6/96 AND CLEANED AND RECALIBRATED THE DEVICE. HE STATED THAT EVERYTHING WAS FINE. OVER THE NEXT FEW DAYS RPTR NOTED THAT THE CONTROL VALVES WERE DROPPING FOR LEVEL 1. ON 3/11/96, RPTR RECALIBRATED THE DEVICE. THE NEXT FEW DAYS, LEVEL 1 WAS STILL DROPPING. ON 3/20/96, RPTR CALLED THE MFR TO SEE WHAT THEY WOULD SUGGEST. MFR TOOK THE INFO (CONTROL AND LOT NUMBERS). SERVICE ENGINEER SAID THAT AN INVESTIGATION WAS TAKING PLACE AND THERE WAS A BIAS IN THE DEVICE. SERVICE ENGINEER SAID THAT THEY HAVE NOT FOUND ANYTHING. IF THEY DO, THEY WILL NOTIFY THE FACILITY. RPTR IS CONCERNED THAT THE MFR IS NOT TAKING RESPONSIBILITY. THE RESULTS THAT THEY ARE GETTING ON THE ANALYZER ARE NOT VALID. IF THEY GIVE THESE RESULTS TO THE DR, IT CAN MAKE A DIFFERENCE BETWEEN PUTTING A PT INTO THE HOSP OR TREATING THEM AT HOME. THIS DEVICE IS USED ON BABIES AND RPTR SAID THAT THEY DON'T WANT TO STICK A NEEDLE INTO A BABY IF THEY DON'T HAVE TO. IT DOES NOT MAKE GOOD PRACTICE.
AT 2:15 AM, IT WAS DISCOVERED THAT THE RESIDENT WAS UNRESPONSIVE AND HAD NO VITAL SIGNS. IT WAS NOTED IN THE NURSES NOTES THAT HIS INNER CANNULA WAS LYING ON HIS CHEST AND ATTACHED TO THE VENT CIRCUIT. THE VENT ALARM WAS IN THE ON POSITION BUT THE ALARM DID NOT SOUND WHEN THE INNER CANNULA CAME OUT.
79-YEAR-OLD MALE ADMITTED WITH CARDIOMYOPATHY. PATIENT WAS BEING MONITORED BY TELEMETRY. TRANSMITTER BATTERY WAS CHARGED 45 MINUTES PRIOR TO ARREST. INFO FROM MONITOR AT CENTRAL STATION INDICATED "WAVE INVALID-BATTERY RANGE." NURSE FOUND PATIENT UNRESPONSIVE AND A CODE WAS CALLED. ATTEMPTS AT RESUSCITATION WERE UNSUCCESSFUL.
PT VENTILATOR DEPENDENT SINCE 4/92. STAFF IN ROOM AT 11:10 PM GIVING AN IN-LINE TREATMENT AND VENTILATOR FUNCTIONING PROPELRY. AT 11:40 PM LAB TECH ENTERED ROOM AND FOUND VENTILATOR TUBING DISCONNECTED FROM TRACH AND RESTING 3-4" BELOW TRACH ON PT'S CHEST. NURSE SUMMONED IMMEDIATELY. NO HEART TONES. NO RESPIRATIONS. VENTILATOR ALARMS NOT SOUNDING. VENTILATOR CONTINUING TO CYCLE. STAFF OBSERVED VENTILATOR FOR 5 ADDITIONAL MINUTES AND ALARM NEVER DID SOUND. PT WAS A DO NOT RESUSCITATE.
CUSTOMER COMPLAINED THAT THE PLASTIC TIP FROM THE END OF THE THROMBOPLASTIN REAGENT PUMP TUBING NO 4 IS SLIPPING OFF. CUSTOMER CLAIMS THAT THEY WERE REPORTING PT VALUES DURING THIS INCIDENT, BUT NO SPECIFIC INFO IS AVAILABLE. THERE IS NO INFO TO SUGGEST THAT PT TREATMENT WAS ALTERED AS A RESULT OF THIS INCIDENT. EVENT DATE: EARLY 12/95.
CUSTOMER NOTED UNUSUALLY LONG PT COAGULATION TIMES WITH THE LAST FEW PT SAMPLES OF A RUN. THESE LONG TIMES WERE REPORTED AND TREATMENT COURSE WAS ALTERED FOR TWO PTS. ONE PT HAD BEEN SCHEDULED FOR SURGERY. HOWEVER, BASED ON THE RESULTS OF COAGULATION TESTING THE SURGERY WAS CANCELLED. ANOTHER PT WAS RECEIVING HEPARIN THERAPY WHILE IN ICU. BASED UPON THE RESULTS OF COAGULATION TESTING, HEPARIN WAS DISCONTINUED FOR A SHORT PERIOD OF TIME AND RESUMED. THE INSTRUMENT FUNCTIONED AS DESCRIBED IN THE LABELING. HOWEVER, LABORATORY PERSONNEL DID NOT HEED ERROR CODE MESSAGES AND REPORTED RESULTS INAPPROPRIATELY. AFTER REVIEWING INSTRUMENT OUTPUT IT APPEARS THE INSTRUMENT WAS OPERATING WITH INSUFFICIENT REAGENT DUE TO AIR BUBBLES OR INSUFFICIENT REAGENT VOLUME.
DURING ERCP, SMALL METALLIC FRAGMENT MARKER BAND SEPARATED FROM CANNULA AND LODGED IN COMMON BILE DUCT.
STENT DISCONNECTED FROM CATHETER. LOST IN VASCULATURE.
DEVICE ALARMED. "INTERNAL ERROR" DISPLAYED.
INCORRECT FACTOR WAS ENTERED BY SYSTEM OPERATOR RESULTING IN A MISADMINISTRATION.  ELECTRONIC COMPONENT WHICH MONITORS DATE/FACTOR ENTRIES MALFUNCTIONED.
MICROSCOPE BULB COATING DISINTEGRATED AND BLEW ONTO OP SITE WHEN FAN WAS TURNED ON.
THE FORCEPS BROOK OFF IN PT DURING A SINUSCOPY PROCEDURE.  X-RAY LOCATED THE BROKEN PIECE AND ADDITIONAL PROCEDURE SCHEDULED TO RETRIEVE IT.
UNIT DESIGN IS SUCH THAT OPERATOR CANNOT SEE LEVEL OF FLUID. PT RECEIVED INADEQATE ANESTHESIA.
SYRINGE TIPS BROKE OFF DURING LIPOSUCTION PROCEDURES.
PROBLEM WITH DELIVERY OF DRUGS DURING SURGERY. CO CHECKED PUMP AND PROVIDED FACILITY FOLLOW-UP INFO WITHIN 3 WEEKS. PROBLEM WAS USER BASED AND NOT IN FUNCTION OF THE PUMP.
DURING PRE-USE CHECKOUT OF VENTILATOR CIRCUIT, THE PT WYE CONNECTOR WAS FOUND TO BE PARTIALLY BLOCKED BY PLASTIC MOLD OVERFLOW.
AFTER POLYP WAS SNARED, COULD NOT REMOVE POLYP OR SNARE WIRE WITH MANY ATTEMPTS TO WITHDRAW SNARE OR REMOVE POLYP.
DURING SURGICAL PROCEDURE IN PT'S RIGHT KNEE, A SMALL METAL PIECE WAS FOUND AND REMOVED. ADDITIONAL IRRIGATION AND POST-OP X-RAY USED TO ENSURE NO ADDITIONAL PIECES REMAINED.
DURING ELECTIVE STERILIZATION PROCEDURE, INSTRUMENT TRANSECTED FALLOPIAN TUBE.
EXTENSIVE TITANIUM WEAR, DEBRIS WITH ADVANCED WEAR OF PATELLAR BUTTON.
DESIGN PERMITTED OXYGEN TO BE CONNECTED TO PRESSURE PORT.
IRRIGATION PUMP PRESSURE READING INCORRECTLY.
ON OR ABOUT JULY 22, 1995 A PATIENT WAS BROUGHT INTO HOSPITAL. A FRAGMENT OF A CATHETER HAD APPARENTLY DISLODGED. THE PATIENT UNDERWENT A TRANSCATHETER RETRIEVAL IN RADIOLOGY FOR REMOVAL OF THE FRAGMENT. CATHETER WAS PLACED AT ANOTHER HOSPITAL.
A 38-YR-OLD MALE PRESENTED WITH CHF. STRESS THALLIUM AND CARDIAC CATH REVEALED A COMBINATION OF INFARCTION AND ISCHEMIA WITH TWO VESSEL DISEASE. THE PT UNDERWENT AN ANGIOPLASTY AND ATHERECTOMY ON 11/14/95. AFTER THE ATHERECTOMY WAS COMPLETED AND AS THE GUIDE WIRE WAS REMOVED, IT WAS NOTICED THAT THERE WAS A WIRE TIP FRACTURE WITH RETENTION OF THE GUIDE WIRE TIP IN THE DISTAL VESSEL. THE WIRE TIP WAS RETRIEVED. HOWEVER, AFTER THE RETRIEVAL IT WAS NOTED THAT TAMPONADE WAS PRESENT. THE PT WAS TAKEN TO EMERGENCY OPEN HEART SURGERY TO REPAIR THE VESSEL. EXAMINATION OF THE FRACTURED END OF THE CORE WIRE SHOWED A TORSIONAL FAILURE OF THE CORE. THE FRACTURE MORPHOLOGY WAS DUCTILE. FAILURE OF THE CORE WIRE WAS CAUSED BY A TORSIONAL OVERLOAD.
CYSTO; RT URETERAL DILATION; STONE MANIPULATION USING STONE RETRIEVAL; URETERAL CALCULUS (STONE) 6MM IN STONE BASKET WAS STUCK AND WAS UNABLE TO RETRIEVE. STONE BASKET WAS STILL IN URETER WHEN PT WAS SENT TO ANOTHER HOSP FOR LITHOTRIPSY. PT RETURNED TO FACILITY WITH NO STONE BASKET. ATTEMPTED STONE EXTRACTION ON 7/24/95. LITHOTRIPSY OCCURRED PM OF 7/24. AM OF 7/25 PT HAD RT NEPHROSTOMY TUBE PLACED. AFTERNOON OF 7/25 DR REMOVED PART OF THE STONE BASKET WITH PART REMAINING IN RT URETER. ON 7/31 DR DID A SUPRAPUBIC RT EXPLORATORY URETEROTOMY AND REMOVED THE REMAINDER OF THE BASKET.
DR WAS PERFORMING THE PROCEDURE OF RIGHT TOTAL HIP REPLACEMENT. WHEN IT WAS TIME TO PLACE THE LINER IN THE SHELL, THE LINER WOULD NOT FIT PROPERLY. A SECOND ATTEMPT WAS MADE AND STILL THE LINER DID NOT STAY IN THE SHELL. THE DURATION OF THE PROCEDURE WAS EXTENDED BY ONE HOUR. DR DECIDED TO USE THE SAME STYLE OF IMPLANT THAT THE PT HAD IN HIS LEFT HIP WITHOUT COMPLICATIONS.
PT WAS ADMITTED TO OR TO HAVE PAINFUL AICD SUBCUTANEOUS PATCH REMOVED. WHEN REMOVED, TISSUE WAS ADHERENT TO PATCH. PATCH SENT TO PATHOLOGY, DR REQUESTED PICTURES TO BE TAKEN OF PATCH. SOME WIRES ON PATCH WERE EXPOSED.
PACEMAKER FAILURE. IMPLANTED AT ANOTHER HOSP. NEW PACEMAKER AND LEADS WERE IMPLANTED.
DR WAS DOING A LUMPECTOMY WITH AXILLARY DISSECTION. DURING THE LUMPECTOMY HE HAD ASKED FOR CURVED MAYO'S TO CUT THE BREAST TISSUE. HE HAD THEN TURNED TO THE SCRUBB NURSE AND ASKED FOR A DIFFERENT PAIR BECAUSE THEY WERE NOT CUTTING. AS THE NURSE TURNED TO GET CURVED MAYO'S FROM SECOND SET-UP, THE DR PICKED UP THE STRAIGHT MAYO'S. WHEN HE PUT THE SCISSORS BACK ON THE MAYO STAND, THE TOP OF THE SCISSORS WAS BROKEN OFF. THE MISSING PIECE WAS BROUGHT TO THE ATTENTION OF THE DR WHO REMOVED THE BROKEN PIECE FROM THE INCISION. THE OTHER SURGEON IN THE ROOM REQUESTED A REPORT BE FILLED OUT.
PUMP ALARMED, CATHETER WAS FILLED WITH BLOOD. THIS REQUIRED EMERGENT REMOVAL. PT WAS NO LONGER BALLOON DEPENDENT. NO SERIOUS SEQUELAE.
BALLOON WAS EMERGENTLY REMOVED. PT WAS RUSHED TO OR FOR THROMBECTOMY OF LEFT SUPERFICIAL FEMORAL ARTERY AS PULSES HAD BEEN LOST IN BOTH LEGS.
JAW OF CLAMP BROKE OFF WHEN CLAMPED ACROSS ASCENDING AORTA. CLAMP WAS REPLACED AND PT WAS OBSERVED. FORTUNATELY BECAUSE OF TIMING, NO SERIOUS SEQUELAE.
DURING EARLY STAGE OF BYPASS DURING OPEN HEART SURGERY CLAMP BECAME LOOSE AND ONE OF THE TIPS BROKE OFF. COULD HAVE BEEN LIFE-THREATENING IF FULL BYPASS HAD BEEN UNDERWAY. HOWEVER, SURGEON ABLE TO APPLY ALTERNATIVE CLAMP IMMEDIATELY.
PILOT BALLOON LEAKING AND REPLACED WITH REPAIR KIT.
DURING RIGHT BREAST BIOPSY NEEDLE BROKE INTO FOUR PIECES BUT APPEARS TO HAVE BEEN CONTAINED WITHIN REMOVED SPECIMEN.
SMALL TEAR NOTED IN CHILD'S RIGHT CHEEK AT END OF OPEN HEART SURGICAL PROCEDURE. THOUGHT TO HAVE BEEN CAUSED BY DRAPE TAPE. REQUIRED SUTURES.
COAGULATOR STOPPED WORKING DURING CRITICAL PORTION OF LIVER TRANSPLANT. FACILITY HAD TO BORROW ANOTHER UNIT FROM ANOTHER HOSP. LATER PRODUCT WAS REPLACED BY CO. PT UNHARMED.
ELECTRODE REMAINED IN BABY'S SCALP AFTER REMOVAL SECONDARY TO ARTIFACT PRODUCTION.
MALFUNCTION OF DISPOSABLE PERFORATOR DURING SURGERY CAUSED DRILL TO COME INTO CONTACT WITH PT'S BRAIN.
TECH HIT CONTROL FOR C ARM WHILE MOVING PT. CONTROL RELEASED BUT ARM CONTINUED TO MOVE STRIKING THE PT IN THE CHEST AND BREAKING AN INFUSION PUMP.
ARTHROSCOPY PUMP MALFUNCTIONED DURING ARTHROSCOPY. FLOW RATE INEXPLICABLY INCREASED ON TWO OCCASIONS RESULTING IN FLUID EXTRAVASATION AND PROCEDURE BEING ABORTED.
ARTHROSCOPY PUMP MALFUNCTIONED DURING ARTHROSCOPY. FLOW RATE INEXPLICABLY INCREASED AND THEN WOULD NOT RUN.
TWO SPRING CLIPS BROKE WHILE ON VESSEL IN THE CHEST.
TRACHEOSTOMY TUBE BECAME DISLODGED. UPON INVESTIGATION IT APPEARED AS IF THE METAL RING SLIPPED DOWN AROUND THE TRACH BALLOON CUFF. PT HAD TO BE INTUBATED.
DURING A FOLLOW-UP ANGIOGRAM WITH BILATERAL RUNOFF OF BOTH LOWER EXTREMITIES, THE AORTIC BALLOON WAS LACERATED BY CALCIUM PLAQUES WITHIN THE VESSEL. ATTEMPTS BY THE RADIOLOGIST TO REMOVE THE DAMAGED BALLOON WERE UNSUCCESSFUL. THE PT WAS THEN SCHEDULED FOR AN UNPLANNED SURGICAL PROCEDURE TO REMOVE FOREIGN BODY NEAR THE AORTIC BIFURCATION AND LEFT TIBIAL-PERONEAL EMBOLECTOMY.
DURING CARDIAC CATHETERIZATION, WHILE ATTEMPTING TO PASS GUIDE WIRE THROUGH THE NEEDLE, INTO THE ARTERY, IT WAS NOTED THAT THE TEFLON COVER FROM THE WIRE WAS STRIPPED OFF. THE PT WAS TAKEN TO X-RAY WHERE A CT SCAN WAS DONE. SCAN DEMONSTRATED THE PIECE WAS LODGED IN THE TISSUE. RADIOLOGIST WAS ABLE TO REMOVE THE DEVICE INTACT BY TRANSCUTANEOUS APPROACH. THERE WERE NO FURTHER PROBLEMS TO THE PT, AND HE WAS DISCHARGED THE FOLLOWING DAY.
SUBCUTANEOUS CATHETER BROKE AND EMBOLIZED. CATHETER PIECE WAS SUCCESSFULLY RETRIEVED FROM THE RIGHT PULMONARY ARTERY 12/1/95.
EXHALATION VENTILATOR FILTER BECAME CLOGGED AND PT UNABLE TO TRIGGER A MANUAL BREATH WITH VENT CYCLE. VENT ALARMED HIGH PRESSURES. PT EXPERIENCED BRIEF PERIOD OF RESPIRATORY FAILURE. PT WAS RESUSCITATED WITHIN MINUTES WITH NO ADVERSE EFFECTS.
OSTEOTOMY INTO TIBIA FOR REMOVAL OF BROKEN DISTAL ASPECT OF INTRAMEDULLARY REAMER IN TIBIAL CANAL WAS DONE.
DURING ATTEMPTED VASCULAR ACCESS WITH SUBCLAVIAN CATHETER, THERE WAS DIFFICULTY PULLING THE GUIDE WIRE BACK. IT UNRAVELED. PROCEDURE WAS ABORTED, REQUIRING PLACEMENT OF FEMORAL CATHETER FOR DIALYSIS. ON 9/18/95, THERE WAS PLACEMENT OF LEFT CATHETER AND RIGHT A/V FISTULA.
CANNULA INTRODUCED INTO AC COLLAR AT TOP OF SYRINGE TURNED INDEPENDENTLY CAUSING CANNULA TO PERFORATE IRIS.
IOL WAS REMOVED DUE TO CHRONIC ENDOPHTHALMITIS. PT WAS TREATED WITH VANCOMYCIN.
THE RESIDENT INVOLVED HAS A HISTORY OF RIGHT-SIDED CEREBRAL VASCULAR ACCIDENT WITH SUBSEQUENT RIGHT-SIDED PARALYSIS OF THE LOWER EXTREMITY. PT IS WHEELCHAIR BOUND. ON THE EVENING OF THE INCIDENT PT WAS BEING WHEELED ABOUT THE NURSING UNIT BY HER HUSBAND, WHO IS ALSO A RESIDENT OF FACILITY. ABOUT 7 PM PT REQUESTED TO BE PUT TO BED. THE CERTIFIED NURSING ASSISTANT TOOK HER TO HER ROOM AND POSITIONED THE WHEELCHAIR BESIDE THE BED. RN THEN LIFTED THE RESIDENT'S GOWN OFF HER LEGS IN PREPARATION TO TRANSFER PT TO BED AND DISCOVERED THE RIGHT PEDAL OF THE WHEELCHAIR IN A PARTIALLY RAISED POSITION, DIGGING INTO THE RESIDENT'S RIGHT LOWER ANTERIOR LEG AT THE SITE OF A FIVE-INCH LACERATION. THIS LACERATION RESULTED IN AN ER ROOM VISIT TO A LOCAL HOSP AND REQUIRED TEN SUTURES TO REPAIR. THE WHEELCHAIR WAS INSPECTED AND HAD NO ROUGH OR SHARP EDGES AND WAS IN PROPER WORKING CONDITION.
TWO PHYSICAL THERAPY ASSISTANTS WERE PERFORMING A MODIFIED BOBATH TRANSFER ON A RESIDENT WITH RIGHT SIDED HEMIPARESIS. HE WAS BEING TRANSFERRED AFTER UNDERGOING PHYSICAL THERAPY FROM AN ELEVATED MAT TO WHEELCHAIR POSITIONED AT HIS LEFT SIDE. THE PEDALS HAD BEEN REMOVED FROM THE WHEELCHAIR IN PREPARATION FOR THE TRANSFER. AS THE RESIDENT WAS LIFTED FROM THE MAT IN A SEMISTANDING POSITION AND PIVOTED TO THE CHAIR, HIS LEFT FOOT SLID OUT TO THE SIDE LATERALLY AND HIS LEG CAUGHT ON THE INNER ASPECT OF THE PEDAL MOUNT PROTRUDING FROM THE LEFT LEG OF THE CHAIR. HE SUSTAINED A DEEP, 4 CM SKIN TEAR ON THE MID LATERAL SURFACE OF HIS LEFT LOWER LEG. HE REQUIRED 14 SUTURES TO CLOSE THE WOUND AND WAS PUT ON PROPHYLACTIC ANTIBIOTICS. THE PEDAL MOUNT IS SEMICIRCULAR WITH A 90 DEGREE ANGLE ON THE INNER ASPECT THAT ALTHOUGH NOT SHARP, IS ANGULAR AND PROTRUDES IN A WAY THAT ALLOWED THE SKIN TO CATCH AND BE HELD AS THE LEG CONTINUED TO SLIDE, CAUSING THE LACERATION.
DURING CIRCUMCISION, THE 1.3 CM CLAMP WOULD NOT SCREW DOWN, RESULTING IN POOR HEMOSTASIS, RESULTING IN 4-0 CHROMIC SUTURES X 8 FOR CONTROL, AND EPINEPHRINE SOAKED GAUZE AND PRESSURE FOR CONTROL.
DURING THE PROCEDURE FOR BONE BIOPSY, RIGHT CALCANEUS, THE WIRE PICK BROKE INSIDE THE CALCANEUS INTO TWO FRAGMENTS. FRAGMENTS WERE VISUALIZED BY C-ARM, BUT WERE TOO DEEPLY EMBEDDED AND NONREMOVABLE AND THEREFORE NONRETRIEVABLE. IF ADDITIONAL DEBRIDEMENT IS NECESSARY THE METAL FRAGMENTS CAN BE RETRIEVED AT THAT TIME.
QUOTED FROM NURSE'S REPORT "I HAVE BOTH EFM (EXTERNAL FETAL MONITOR) AND IFM (INTERNAL FETAL MONITOR) RECORDED FHR (FETAL HEART RATE) 110-120'S FOR #1 TWIN FROM 1511 PM UNTIL PT BROUGHT TO DELIVERY ROOM AT 2238; THERE WAS BOTH AUDIBLE AND VISIBLE TRACING. I BROUGHT FETAL MONITOR TO DELIVERY ROOM AND CONTINUED TO USE EXTERNAL FETAL MONITOR ON BOTH TWIN 1 AND TWIN 2 DURING FORCEPS DELIVERY. AT DELIVERY OF TWIN 1'S HEAD IT WAS OBVIOUS THAT SHE, AN INFANT GIRL, WAS A FETAL DEATH IN UTERO PROBABLY GREATER THAN 48 HOURS BECAUSE OF THE MACERATED APPEARANCE." TWIN #2 WAS DELIVERED ALIVE WITHOUT INCIDENT. AN AUTOPSY WAS PERFORMED ON TWIN #1. THE AUTOPSY REPORT REVEALED: 1. INTRAUTERINE FETAL DEMISE. 2. MACERATED 36 WEEK FEMALE FETUS (202.5 GRAMS). 3. DICHODONIC; DIAMNIOTIC PLACENTA SHOWING MULTIPLE FOCI OF VILLOUS EDEMA CONSISTENT WITH FETAL HYPOXIA. (*)
PT WAS IN SURGERY FOR HEMI-ARTHROPLASTY, AFTER A FEMORAL NECK FRACTURE. THE CANAL WAS REAMED TO SIZE 2. CEMENTED PROSTHESIS. THE CEMENT INSERTED SET UP EXTREMELY FAST (3 1/2 MIN), HARDENING DURING INSERTION OF FINAL PROSTHESIS WHICH WAS ONLY 1/2 WAY DOWN. DURING ATTEMPTS TO REMOVE CEMENT, A SPIRAL FRACTURE WAS CREATED. OPEN REDUCTION AND INTERNAL FIXATION WAS PERFORMED. PT WILL BE NON-WEIGHT BEARING FOR 3 MONTHS.
RUPTURED LEFT BREAST IMPLANT WAS REMOVED AND REPLACED WITH DIFFERENT SIZE SALINE FILLED MAMMARY PROSTHESIS.
PROSTHESIS MALFUNCTIONED. IT WAS REMOVED AND REPLACED WITH A MALLEABLE PENILE PROSTHESIS.
THIS PT OFFERED NO COMPLAINTS PRE-TREATMENT. HER TREATMENT STARTED AT 6:45 AM. AT 9:25 SHE C/O ABDOMINAL CRAMPS. BP WAS 88/60. SHE WAS GIVEN 400CC NS. AT 9:45 PT AGAIN C/O ABDOMINAL PAIN. NS GIVEN AND GOAL DECREASED. DR NOTIFIED. PT ASKED TO HAVE TREATMENT DISCONTINUED AT 10:20 AM. CONTINUED TO C/O ABDOMINAL PAIN, VOMITED ONCE, DR CALLED, PT WAS SENT TO ER AND ADMITTED FOR HEMODIALYSIS. NO KINKS WERE NOTED IN THE LINES. THE MACHINE WAS PULLED AND CHECKED. THE BLOOD PUMP WAS FOUND TO BE MALOCCLUDED. NO OTHER PROBLEMS WERE FOUND WITH THE MACHINE. THE PT IS BACK TO THE CENTER FOR HER TREATMENTS.
PACEMAKER UPPER LIMIT WAS SET FOR 110 BEATS PER MINUTE. PACEMAKER WAS FIRING AT 167 BEATS PER MINUTE. PACEMAKER WAS EXPLANTED AND RETURNED TO MFR.
DURING ROUTINE REMOVAL OF DRAIN, IT BROKE, NECESSITATING RETURN TO THE OR. NO FURTHER COMPLICATIONS AND PT WAS DISCHARGED THE FOLLOWING DAY.
GENERATOR PORTION OF SPINAL CORD STIMULATOR APPARENTLY MALFUNCTIONED. PT REPORTED RETURN OF PAIN AND REQUESTED REMOVAL.
THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INFO PROVIDED IS BASED ON GENERAL TESTING AND INFO RATHER THAN TESTING OF THE ACTUAL DEVICE. 1.1 THE POWER CORD AND STRAIN RELIEFS ON THE STRYKER MODEL 3000 MPS BED MEET THE UL544 STANDARD FOR MEDICAL AND DENTAL EQUIPMENT STANDARD AS TESTED ACCORDING TO 7.2.3.5 (COPY ENCLOSED). 1.2 A FAILURE ANALYSIS HAS NOT BEEN CONDUCTED ON THE STRAIN RELIEFS DUE TO THE FACT THAT DURING TESTING FAILURE DID NOT OCCUR AND THIS IS THE FIRST REPORTED INCIDENT OF FAILURE IN THE FIELD. 1.3 THE SUCCESS OF THE UL TEST RESULTS COUPLED WITH THE FACT THAT THIS IS THE ONLY REPORTED INCIDENT OF FAILURE OF THIS TYPE LEADS TO THE CONCLUSION THAT THIS WAS AN ISOLATED INCIDENT. 2. A STRYKER SVC REP INSPECTED THE BED AND FOUND THAT THE STRAIN RELIEF WAS MISSING. THERE WERE CUTS IN THE CORD WHERE THE STRAIN RELIEF SHOULD BE. THIS APPEARED TO HAVE HAPPENED BECAUSE OF THE BED BEING MOVED WITHOUT BEING UNPLUGGED FIRST. 3. THIS IS THE FIRST REPORTED INCIDENT OF THIS TYPE. 4. DUE TO THE CIRCUMSTANCES OF THIS INCIDENT AND THE FACT THAT THIS IS THE ONLY REPORTED INCIDENT OF THIS TYPE IT HAS BEEN DETERMINED THAT REMEDIAL ACTION IS UNNECESSARY.
WHILE TESTING PT DETERMINED THAT THE TEST LATEX FOR URINE RAPID SCREENS WAS NOT REACTING PROPERLY. THE CONTROLS DID NOT REACT IN THE CORRECT MANNER. FURTHER INVESTIGATION REVEALED THAT 2 INCORRECT POSITIVE STREP B URINE RAPID SCREEN RESULTS HAD BEEN REPORTED 2/28/96 ON A SECOND AND THIRD PT. REPEAT TESTING 3/3 FOR THE SECOND PT SHOWED NEGATIVE RESULTS WITH ANOTHER LOT NUMBER. RESULTS WERE CORRECTED AND THE NURSE WAS NOTIFIED OF PROBLEM. THE THIRD PATIENT HAD ALREADY BEEN DISCHARGED BY 3/3. THE PT WAS CALLED BACK AND REPEAT TESTING WAS PERFORMED 3/6/96. REPEAT TESTING AND RESULTS WERE CORRECTED. ADD'L DATE OF EVENT 3/3/96.
22-20G MIDLINE CATHETER INSERTED AND FLUSHED WITH SALINE. PT IMMEDIATELY BECAME FLUSHED, SOB, C/O CHEST TIGHTNESS, NAUSEA AND LIGHT-HEADEDNESS. BP 130/82, P96. MIDLINE CATHETER DISCONTINUED. PERIPHERAL LINE STARTED AND PT IMPROVED.
PT HAD ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF LEFT KNEE 7/6/95. METAL WIRE BROKE AND REMAINED IN PT'S KNEE. PT HAD SURGERY TO REMOVE WIRE ON 3/4/96.
PT HAD TOTAL HIP REPLACEMENT. HE HAD 2 DISLOCATIONS POST-OP. BALL HEAD REPLACED 3/8/96. APPEARS DEFECTIVE. TWO SCREWS USED DURING INSERTION OF NEW ACETABULAR CUP BROKE OFF. (ALSO SEE 1008729).
INTERMEDICS ORTHOPEDICS, INC. 9900 SPECTRUM DR, AUSTIN, TX 78717. THE PT IS A 39-YR-OLD MALE WHO HAD A BADLY FRACTURED ACETABULUM FROM AN ACCIDENT SEVERAL YEARS EARLIER. THE HIP WAS REVISED BY DR ALTMAN ON 2/15/96. AN EXTENSIVE ALLOGRAFT WAS PLACED INTO THE ACETABULUM. AFTER A COUPLE WEEKS, THE PT STARTED DISLOCATING AND IT WAS CONFIRMED THAT TEH ALLOGRAFT WAS NOT HOLDING THE IMPLANT IN PLACE (IT WAS SHIFTING). DR ALTMAN DETERMINED THAT THE RE-REVISION WAS NECESSARY AND ON 3/8/96 HE PERFORMED THE RE-REVISION. WHEN HE REMOVED THE SHELL FROM THE ACETABULUM, IT WAS NOTICED THAT THE TWO CANCELLOUS SCREWS HAD SHEARED OFF. THIS DID NOT HAPPEN DURING THE SURGERY, BUT DUE TO THE SHELL SHIFTING IN THE ALLOGRAFT. THE CERAMIC HEAD IS CONSIDERABLY WORN/BURNISHED. THE HOSP DOES NOT SUSPECT ANY MATERIAL DEFECTS, BUT WOULD LIKE A REPORT FOR THEIR OFFICIAL RECORDS, SINCE THIS WAS A RE-REVISION CASE. AN EXPLANTED INTERMEDICS ORTHOPEDICS, INC. (IOI) 28MM/-4MM NECK LENGTH 12/14 TAPER CERAMIC HEAD CAT #7666-44-028 AND TWO TITANIUM FULLY THREADED CANCELLOUS BONE SCREWS CAT #'S 4301-07-05 AND 4301-07-045 WERE RECEIVED AND DELIVERED TO MATERIALS TECHNOLOGY (IOI) FOR ANALYSIS. THE CERAMIC HEAD AND SCREWS HAD BEEN REMOVED DURING A RE-REVISION SURGERY NECESSITATED BY HEAD-INSERT DISLOCATION CAUSED BY SHIFTING OF ACETABULAR SHELL. SCREWS HAD APARENTLY BROKEN DURING SVC AND ONLY BETWEEN 8-9 MM OF EACH SCREW (ENCOMPASSING SCREW HEAD) WERE RETURNED TO IOI. IN ADDITION TO PERFORMING FAILURE ANALYSIS OF SCREWS, EXAMINATION OF CERAMIC HEAD WAS REQUESTED DUE TO "CONSIDERABLE BURINISHING" DETECTED ON APPROX ONE-HALF OF HEAD. THE BURNISHING OF CERAMIC DEVICE WAS DUE TO ABRASION OF HEAD AGAINST A SOFTER METALLIC MATERIAL. DEVICE WAS MFG FROM ALUMINUM OXIDE (PER ISO 6474) WHICH HAS A HARDNESS OF 91 (HARDNESS ROCKWELL R45N). APR ACETABULAR SHELL, MADE FROM TI-6AI-4V (PER ASTM F-136), HAS A HARDNESS OF APPROX 34 (HARDNESS ROCKWELL R45N). WHEN THE TWO MATERIALS ABRADE AGAINST EACH OTHER SOFTER MATERIAL WILL ALWAYS BE REMOVED AND/OR DEPOSITED ONTO HARDER MATERIAL. CONDITION OF HEAD IS NOT INCONSISTENT WITH WHAT WOULD BE EXPECTED FOLLOWING SUCH A COMPLICATION (IE, DISLOCATION). BOTH TITANIUM BONE SCREWS FAILED DUE TO SHEAR FRACTURE CAUSED BY OVERLOADING. THIS OCCURRED BECAUSE THE SHEAR STRENGTH OF MATERIAL, TI-6A1-4V (PER ASTM F-136), WAS EXCEEDED. SINCE ULTIMATE TENSILE STRENGTH OF THIS MATERIAL IS APPROX 120 KSI, PURE SHEAR STRENGTH IS AROUND 60 KSI. THEREFORE, EACH SCREW MUST HAVE BEEN EXPOSED TO SHEAR STRESSES EXEEDING THIS LEVEL. EXCESSIVE STRESS CONDITION WAS MOST PROBABLY CAUSED BY "SHIFTING OF ALLOGRAFT" DURING POST SURGERY AMBULATION. PRODUCT PACKAGING INSERT COVERS CONTRAINDICATIONS SUCH AS PTS PHYSICAL CONDITION, PREVIOUS SURGERY, INSUFFICIENT QUALITY OR QUANTITY OF BONE AND POTENTIAL ADVERSE EFFECTS SUCH AS CHANGING POSITION OF PROSTHESIS OR FISSURE OF ACETABULUM. I HAVE INCLUDED A COPY OF PACKAGING INSERT (#270003 REV D) WITH THESE AREAS HIGHLIGHTED.
2/16/96 PHYSICIAN STATES STAPLE LINE FAILURE. FROM DISCHARGE SUMMARY: 11/27-12/6/95 "HE DID WELL POST OPERATIVELY WITH MINIMAL PAIN." FROM DISCHARGE SUMMARY 1/10/96-1/15/96 "POSTOPERATIVELY HE DID WELL. HE WAS DISCHARGED WITH HIS LUNG COMPLETELY EXPANDED. BUT IN SUBSEQUENT WEEKS, HE DEVELOPED FLUID REACCUMULATION OF THE APICAL ASPECT OF THE LEFT CHEST. CHEST TUBE WAS INSERTED; CULTURE SHOWED LETTER BACTAMOSE ENTEROCOCCUS FECALIS." 11/27/96 THORACOTOMY, LEFT UPPER LOBECTOMY. DISCHARGED 12/6/95, READMITTED 1/10/96 AND DISCHARGED 1/15/96.
2/16/96 PHYSICIAN STATES STAPLE LINE FAILURE. PHYSICIAN USED MFR'S 4.5 MM ROTICULATED STAPLER ACCORDING TO POST-OP NOTE. 1/2/96 LEFT UPPER LOBECTOMY, BRANCH LEFT UPPER BRONCHOTOMY. 1/3/96 THERAPEUTIC BRONCHOSCOPY FOR ATELECTASIS, LEFT LOWER LOBE. 1/11/96 THORASCOPY/BRONCHOSCOPY TO RULE OUT, BRONCHOPLEURAL FISTULA AND BRONCHIAL STUMP LEAK.
DR ATTEMPTED TO PUT A LINE OF STAPLE ABOVE A LEFT LOWER LOBE NODULE. THE INSTRUMENT DID NOT FIRE THE STAPLES. A SECOND ONE WAS OBTAINED AND IT WOULD NOT FIRE. THE NAME OF THE INSTRUMENT (LINEAR CUTTER) IMPLIES THAT IT WILL CUT TISSUE WHEN IT ACTUALLY ONLY FIRES A STAPLE LINE. VERY CONFUSING TO ALL CONCERNED. RPTR CONTACTED THE "REP" EXPLAINED EVERYTHING RPTR ATTEMPTED TO DO. ALL WAS USED CORRECTLY. DEVICES HELD FOR INSPECTION BY MFR.
DURING DIALYSIS, VENOUS NEEDLE FELL OUT OF PT, CAUSING BLOOD LOSS WITH NO VENOUS PRESSURE ALARMS FROM MACHINE. BLOOD PUMP ALARMS WERE CHECKED AND FOUND TO WORK CORRECTLY TO MFR'S SPEC. THIS HAPPENED TWO TIMES AGAIN. STAFF INSERVICED ON TAPING VENOUS NEEDLE. TWO DIFFERENT KIDNEY DIALYSIS MACHINES FAILED TO ALARM PROPERLY. SERVICEMAN FROM CO COULD NOT EXPLAIN, SUGGESTS KINK IN TUBING.
HIGH PACING IMPEDANCE AFTER X-RAY TO VERIFY LEAD PLACEMENT, NECESSITATED EXPLANTING DEVICE.
UNABLE TO FLOW BLOOD THROUGH OXYGENATOR HEAT EXCHANGER.
RPTR RECEIVED SALINE IMPLANTS IN 1979. WITHIN MONTHS SHE BEGAN TO FEEL MALAISE AND FATIGUE. IN THE INTERVENING YEARS, SHE HAS BEEN DIAGNOSED WITH POSSIBLE PORPHYRIA BECAUSE OF SKIN RASHES AND ABDOMINAL PAIN. LATER, SHE WAS DIAGNOSED WITH POSSIBLE MULTIPLE SCLEROSIS AND LUPUS, AS WELL AS FIBROMYALGIA. PRIOR TO HER IMPLANTATION, SHE WAS HEALTHY WITH GOOD ENERGY. NOW, SHE IS IN THE PROCESS OF APPLYING FOR SSDI BECAUSE OF PAIN, FATIGUE, MEMORY AND CONCENTRATION LOSS, AS WELL AS DEPRESSION AND OTHER NEUROLOGICAL DEFICITS (BURNING AND NUMBNESS).
PT HAS PERMANENT MEMORY LOSS AFFECTING ABILITY TO FUNCTION AS BEFORE ECT. PT C/O LOSS OF VOCABULARY, LOSS OF MEMORY, OF MUCH LEARNED KNOWLEDGE, INABILITY TO RETAIN NEW INFORMATION, INABILITY TO GRASP NEW CONCEPTS, MUCH MEMORY LOSS OF PERSONAL EVENT PRIOR TO AND AFTER ECT, AND PSYCHOLOGICAL EFFECT OF THIS BARBARIC TREATMENT. CONTINUED BOUTS OF DEPRESSION.
AS AN OPERATING ROOM NURSE, RPTR WAS CIRCULATING FOR A COMPLICATED CASE REQUIRING MANY GLOVE CHANGES. SHE BEGAN HAVING ITCHY AND SWOLLEN EYES AND WITHIN AN HOUR SHE WAS HAVING DIFFICULTY BREATHING. SHE WAS SEEN IN THE ER AND WAS GIVEN EPINEPHRINE. WAS DIAGNOSED WITH ANAPHYLAXIS TO LATEX PARTICLES IN THE AIR. RPTR HAS WORKED IN THE OR FOR EIGHT YEARS. SHE HAS WORN LATEX GLOVES EXTENSIVELY SCRUBBING AND CIRCULATING ALMOST DAILY. RPTR WAS SEEN BY AN ALLERGIST AND WAS REMOVED FROM THE OR AND THE CLINICAL SETTING WHERE SHE HAD BEEN FOR 20 YEARS. SHE HAS AN EPINEPHRINE PEN TO CARRY.
THE SAMPLE RETAINED FOR ANALYSIS WAS EXAMINED BY CO'S QUALITY ENGINEER. LOT HISTORY REVIEWS SHOWED NO PROBLEMS DURING THE MFR OF THE LOTS. VISUAL EXAMINATION OF THE UNIT REVEALED FOREIGN ON THE CATHETER AND ADAPTER. UNIT WAS SENT TO MATERIALS EVALUATION LAB FOR FURTHER ANALYSIS. THE FOREIGN MATERIAL WAS IDENTIFIED AS ALUMINUM OXIDE, WHICH IS APPARENTLY FROM THE ASSEMBLY MACHINE. NO FURTHER INVESTIGATION NEEDED, FOREIGN MATERIAL WAS IDENTIFIED BY QUALITY ENGINEER. ALL WAS CONFIRMED AS REPORTED IN THIS MEDWATCH REPORT. THIS WAS NOT REPORTED AS A MDR.
UPON INSERTING SUPRAPUBIC CATHETER INTO PT, SILASTIC SHEATH BROKE AWAY FROM POINT OF ATTACHMENT. ANOTHER CATHETER WAS USED.
RPTR IS AN RN WORKING IN AN ENDOSCOPY DEPT IN A HOSP. SHE STARTED HAVING DERMATITIS ON HANDS FROM LATEX GLOVES IN 11/92. 6/17/93 SHE WAS REFERRED TO DERMATOLOGIST WHO SAID THE HAND RASH, SWELLING AND HIVES WAS NOT RELATED TO THE LATEX GLOVES, BUT WAS DUE TO FREQUENT HANDWASHING. ON 10/21/93 WHILE DOING A PROCEDURE RPTR DEVELOPED HIVES ON ENTIRE BODY, HAD UPPER AIRWAY SWELLING, STRIDOR AND THEN ANAPHYLAXIS. AFTER THIS, SHE WAS DIAGNOSED AS HAVING A LATEX ALLERGY. SHE CONTINUES TO WORK. HER DEPT USES VINYL OR OTHER NON-LATEX-CONTAINING PRODUCTS AS POSSIBLE. SHE STILL HAS AN ALLERGIC REACTION EVERY 2-3 MONTHS, BE IT AT HOME, OUT SOCIALIZING, AT A STORE OR AT WORK. 12/94 DIAGNOSED WITH OCCUPATIONAL ASTHMA DUE TO LATEX ALLERGY. 10/95 DIAGNOSED WITH MILD REACTIVE AIRWAY DISEASE RELATED TO LATEX ALLERGY.
RPTR C/O LATEX ALLERGY. AFTER WORKING AS AN RN SINCE 1977, RPTR DEVELOPED SEVERE ALLERGY SYMPTOMS, WORSENING IN 1991. SYMPTOMS INCLUDED ANGIOEDEMA, EXZEMA ON HANDS, WHEEZING, WELTS ON FINGERS WHEN USING LATEX GLOVES, AND FINALLY ANAPHYLAXIS TO AVOCADO WHICH HAS BEEN SHOWN AS A CROSS-REACTOR WHEN LATEX ALLERGY DEVELOPS. SHE HAS SWOLLEN LIPS AND WHEEZING AFTER BLOWING UP BALLOONS. ALLERGY DEVELOPED TO BANANA AND AVOCADOS. SHE HAS RUNNY NOSE AND SNEEZING WHEN AROUND LATEX PRODUCTS. SHE HAS CLASSIC CLINICAL SYMPTOMS.
RPTR WAS TAKING BLOOD FROM A PT WHEN RPTR NOTICED THERE WASN'T ANY BLOOD FLOWING. AS RPTR TOOK THE TUBE OFF TO PLACE ANOTHER ONE, BLOOD BEGAN TO SPOUT OUT INTO THE VACUUM CONTAINER. RPTR IMMEDIATELY BLUNTED AND REMOVED NEEDLE FROM ARM. AFTER FURTHER INVESTIGATION THE SAFETY GUARD WAS FOUND TO BE SEVERELY BENT.
PT'S MOTHER HAD BREAST IMPLANTS PLACED 1/16/80. SHE HAD BLEEDING THROUGH ENVELOPE. IMPLANTS WERE INTACT. SHE HAD CAPSULAR CONTRACTURES AND OPEN CAPSULOTOMIES. PT HAS CHRONIC BLADDER/URINARY INFECTIONS, OTHER NEUROPATHY, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, CHEST/RIB CAGE: PAIN &/OR BURNING SENSATION, ELEVATED CHOLESTEROL OR TRIGLYCERIDES, DRY EYES, CHRONIC PAIN, SENSITIVITY OF EXTREMITIES, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME, VAGINAL BURNING WITH NO MEDICAL EVIDENCE, FREQUENT MIGRAINES/SEVERE HEADACHES, PAROXYSMAL ATRIAL TACHYCARDIA, HYPERSENSITIVITY TO: CHEMICALS, MOLDS, DUST OR POLLEN, UNUSUAL CHRONIC INFECTIONS, JOINT INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS, GROIN AND NECK, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, NEEDLES IN LEGS AND ARMS, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, LONG-TERM EXTREME FATIGUE AND SICCA.(*)
PT'S MOTHER HAD BREAST IMPLANTS PLACED 1/16/80. BIOPSIES WERE DONE ON TISSUE SAMPLES. A MEDICAL PROFESSIONAL CONFIRMED SILICONE IN MOTHER'S LYMPH NODES UNDER ARMS, SHOULDERS AND UNDER BREAST. SHE HAD NUMBNESS IN THE SURGICAL AREA AND BLEEDING THROUGH ENVELOPE. IMPLANTS WERE INTACT. SHE HAD 2 BILATERAL CAPSULAR CONTRACTURES AND 2 OPEN CAPSULOTOMIES. PT HAS CHRONIC BLADDER/URINARY INFECTIONS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFUCULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, CHEST/RIB CAGE: PAIN &/OR BURNING SENSATION, ELEVATED CHOLESTEROL OR TRIGLICERIDES, DRY EYES, THYROID PROBLEMS, CHRONIC PAIN AND HEAT SENSITIVITY, FREQUENT LOW GRADE FEVER,  IRRITABLE BOWEL SYNDROME, INFERTILITY, POLYCYSTIC OVARIAN PROBLEMS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATION, FREQUENT MIGRAINES/SEVERE HEADACHES, HYPERSENSITIVITY TO: CHEMICALS, MOLDS, DUST OR POLLEN, UNUSUAL CHRONIC INFECTIONS, LUPUS, ATYPICAL LUPUS, JOINT INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY, UNDER ARMS, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, FIBROMYALGIA, UNEXPLAINED RASHES, SUN SENSITIVITY, NUMEROUS MOLES, FRECKLES, ETC, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, LONG-TERM EXTREME FATIGUE, CLUMSINESS/DROPS THINGS, MISJUDGES DISTANCE/RUNS INTO OBJECTS, AND SICCA.(*)
PT'S SILICONE IMPLANTS WERE REMOVED ON 4/14/93. THE RIGHT IMPLANT HAD RUPTURED PRIOR TO SURGERY. PATHOLOGIST'S REPORT SHOWED "FOREIGN BODY GIANT CELL REACTION" OF TISSUE FROM RIGHT CAPSULE. PT HAS BEEN DIAGNOSED WITH AUTO-IMMUNE CONDITION WHICH MD BELIEVES WAS CAUSED BY IMPLANTS. PT IS DISABLED DUE TO THIS CONDITION (UNABLE TO WORK). PT HAD SECOND SURGERY 6/1/94 TO REMOVE SILICONE GRANULOMATA. (*)
PT WITH CORONARY ARTERY DISEASE AND MYOCARDIAL INFARCTION WAS IN CARDIOGENIC SHOCK. ANGIOPLASTY OF THE ANTERIOR TRUNK WAS DONE AND PT PLACED ON BALLOON PUMP. PUMP CATHETER FAILED NECESSITATING A SECOND CATHETER INSERTION. RPTR WAS UNABLE TO REMOVE THE FIRST CATHETER BECAUSE IT WOULD NOT COME OUT. PT DIED SHORTLY THEREAFTER. POST SHOWED AN 1" BY 1" BLOOD CLOT. FEEL THAT THERE WAS SOME KIND CATHETER LEAK.
EAR IMPLANT WAS REPLACED DUE TO MALFUNCTION OF DEVICE.
ACUTE PERICARDIAL TAMPONADE AFTER PERMANENT PACEMAKER IMPLANTATION WITH RIGHT VENTRICULAR PUNCTURE WOUND OCCURRED.
WHILE REMOVING IABP CATHETER, THE BALLOON BECAME LODGED. WHEN IT WAS REMOVED WITH INCREASED FORCE, IT WAS NOTED TO HAVE OLD BLOOD AND A LARGE CLOT IN THE BALLOON. ALSO NOTED TO HAVE 3 TINY HOLES.
FRACTURED CATHETER WAS IN SVC TO LPA. REQUIRED PERCUTANEOUS REMOVAL OF A FREE FLOATING CATHETER IN HEART AND LEFT PULMONARY ARTERY.
PT BROUGHT INTO ER BY AMBULANCE WITH LOSS OF CONSCIOUSNESS. IV STARTED BY AMBULANCE CREW. INITIAL IV WAS DISCONTINUED BY ICU NURSE WHO FOUND END OF CATHETER BROKEN OFF. X-RAY SHOWED TIP OF CATHETER LODGED IN SOFT TISSUE OF LEFT UPPER ARM. PHYSICIAN CHOSE NOT TO SURGICALLY REMOVE CATHETER TIP AT THIS TIME.
PT HAD PENILE IMPLANT IMPLANTED IN 8/87. THIS FAILED IN 1988 AND HE HAD ANOTHER IMPLANT PLACED AT THAT TIME. THIS SECOND IMPLANT ALSO FAILED (EG, WOULD NOT INFLATE) AND WAS REMOVED 12/29/95.
DR PERFORMED HYSTEROSCOPY, D&C, AND ENDOMETRIAL ABLATION. THE OPERATIVE REPORT NOTED THAT AFTER THE UTERINE CAVITY WAS CURETTED AND SENT TO PATHOLOGY, THE RESECTOSCOPE WAS REINSERTED. WHILE USING SYSTEMATIC BURNING ACTION, THE ENTIRE ENDOMETRIAL CAVITY WAS ELECTROCOAGULATED AND DESICCATED. THEN THE ENDOCERVICAL CANAL WAS ALSO ELECTROCOAGULATED AT THE INTERNAL ORIFICE, BUT THE ENTIRE ENDOCERVICAL CANAL WAS LEFT INTACT. AFTER THE HYSTERSCOPE WAS REMOVED, DR NOTED SLOUGHING OF THE VAGINAL MUCOSA OF THE ORIFICE AND THE ANTERIOR PORTION OF THE VAGINAL VAULT. DR APPLIED SILVADENE CREAM TO THE EXTERNAL BURN AREA.
SEALED PACKAGE RECEIVED WITHOUT PRODUCT WITHIN.
THE CUFF MARKINGS IN THE ACCEPTABLE ARM SIZE FOR THIS DEVICE DO NOT MEET AMERICAN HEART ASSOCIATION GUIDELINES. THIS COULD LEAD TO HIGH BLOOD PRESSURE READINGS ON MANY PTS.
THE RUBBER BLADDER INSIDE PT CUFF IS TOO SMALL (CHILD SIZE) AND THIS MAY RESULT IN HIGH READINGS.
ALL SYRINGES MEASURED IN CC INSTEAD OF ML. ALL DRUGS ARE MEASURED IN MLS, NOT CC'S. THIS IS INCONSISTENT.
PT WAS ADMITTED FOR ACUTE APPENDICITIS 2/22/96. PRE-SURGICAL LABWORK WAS ORDERED AT 14:43. THE SECOND SHIFT HAD JUST STARTED AND THE TECHNOLOGIST HAD JUST RUN QC ON THE DEVICE. ALL QC WAS WITHIN LIMITS. SHE THEN RAN THE PT AND APTT ON PT. THE APTT RESULTS WERE MARKEDLY ELEVATED AT 60 SEC. SHE REMADE CONTROLS AND REAGENTS AND REPEATED THE QC. THE QC WAS AGAIN WITHIN LIMITS. THE LABWORK WAS THEN REPEATED. RESULTS WERE STILL ELEVATED AT 40 SEC FOR THE APTT. BY THIS TIME THE PT WAS IN THE SURGERY HOLDING AREA. A REPEAT PT AND APTT WERE ORDERED ALONG WITH AN IVY. BLEEDING TIME AND FIBRINOGEN AT 16:31. SEE RESULTS BELOW. THE SURGERY WAS POSTPONED DUE TO ELEVATED RESULTS AND THE PT WAS TRANSFERRED TO ANOTHER MEDICAL CENTER. THE SAME TESTS WERE REPEATED AT THE OTHER MEDICAL CENTER. ALL RESULTS WERE NORMAL PER THE ATTENDING PHYSICIAN.
57 MM LINEAR CUTTER MISFIRED RESULTING IN A LARGE LEAK IN THE STAPLE LINE. DR HAD TO PERFORM ANOTHER SEGMENTED SMALL BOWEL RESECTION.
WHILE REMOVING STRETCHER FROM THE VAN, THE STRETCHER WHEELS CAME DOWN BUT MALFUNCTIONED ALLOWING STRETCHER TO FALL RAPIDLY TO THE GROUND. THE RESIDENT ON THE CART APPEARED TO HAVE NO PERMANENT INJURIES. THE VAN DRIVER, WHO IS A CNA, AND ANOTHER CNA WHO WERE UNLOADING THE STRETCHER HAD TRIED TO PROTECT THE RESIDENT DURING THE INCIDENT. ONE CNA IS COMPLAINING OF BACK AND NECK PAIN AND WENT TO A CHIROPRACTOR. THE EMPLOYEE IS CURRENTLY ON VACATION. SALES REP CHECKED STRETCHER (3/26/96). STRETCHER WORKED UNLESS WEIGHT WAS APPLIED. DID NOT WORK 10 TIMES WHEN TESTED WITH WEIGHT 3/26/96. INFORMED 3/26/96 THAT CO REP COMING TO CHECK EQUIPMENT. STRETCHER WAS ORDERED 11/94 AND WAS DELIVERED 12/94. WAS PLACED IN STORAGE UNTIL 3-4 WEEKS AGO. COULD NOT BE USED WITH OLD VAN, AWAITING PURCHASE OF NEW VAN.
RPTR HAD AN ALLERGIC REACTION TO THE PRODUCT.
THE TRANSPORT VENTILATOR OVERHEATED AND MELTED.
ON 10/2/95 TWO DISKS WERE REMOVED FROM THE PT'S BACK. SIX PEDICLE SCREWS AND 2 RODS WERE INSTALLED. THE PT GOT AN INFECTION AFTER THE SURGERY AND IT TOOK HIM ONE MONTH TO RECOVER. AFTER THAT, HE EXPERIENCED SEVERE PAIN. PT WANTED THE DEVICE TO BE REMOVED BUT THE DR SAID HE CAN'T REMOVE IT UNTIL HE TRIED TO "INFUSE" IT.
THE COMPLAINANT STATED HE HAD SINUS SURGERY ON 12/26/95. HE WAS RELEASED THE FOLOWING DAY AND GIVEN A VAPORIZER, AS PART OF HIS THERAPY, BY THE HOSP. HE STATED HE USED IT ACCORDING TO MFR'S INSTRUCTIONS. THERE WERE NO CONTROLS ON THE UNIT, WHICH WAS ACTIVATED WHEN PLUGGED INTO AN OUTLET. HE STATED ON THE NIGHT OF THE INCIDENT, HE FILLED THE VAPORIZER WITH WATER; UP TO 2 QUARTS AND PLUGGED THE UNIT IT. AFTER THE UNIT HAD BEEN ON FOR APPROXIMATELY FIVE TO SIX HOURS, THE COMPLAINANT WAS AWAKENED BY A FLASH OF BRIGHT LIGHT, LOUD POPPING SOUND, AND A BURNING ODOR. HE FOUND THE VAPORIZER WAS "OFF." HE IMMEDIATELY UNPLUGGED THE UNIT; THEN PLUGGED IT BACK INTO THE OUTLET TO SEE IF IT WOULD ACTIVATE, BUT IT WOULD NOT. HE STATED IT SHUT OFF BECAUSE HE BELIEVES THE MOTOR BURNED OUT. HE CONTACTED THE MFR AND EXPLAINED WHAT HAD HAPPENED. THE MFR'S RESPONSE WAS THAT IT WOULD TAKE SEVERAL WEEKS FOR THEM TO GET THE UNIT BACK AND TESTED, AND THEY WERE NOT CERTAIN IF THEY COULD SEND HIM A REPLACEMENT. HE CONTACTED THE HOSP AND INFORMED THEM OF THE DEFECT IN THE VAPORIZER. HE STATED HE WAS ADVISED TO BRING THE UNIT BACK FOR A REPLACEMENT. HE STATED A MEMBER OF THE NURSING STAFF STATED THIS TYPE OF PROBLEM HAD NEVER OCCURRED WITH THE MODEL INVOLVED. HE STATED HE PICKED UP A LIKE MODEL AND TOOK IT HOME. ON 1/24/95, PRIOR TO GOING TO BED, HE POURED THE RECOMMENDED TWO QUARTS OF WATER INTO THE UNIT, AND PLUGGED IT INTO AN OUTLET. AFTER FIFTEEN MINUTES OR LESS, HE SMELLED A BURNING ODOR, SAW SPARKS COMING FROM THE VAPORIZER'S MOTOR, AND FOUND THE UNIT TO BE "OFF." THE COMPLAINANT STATED WATER WAS INSIDE BOTH VAPORIZERS, DURING BOTH INCIDENTS. THE COMPLAINANT STATED THE VAPORIZERS SHORTED OUT. HE STATED THE UL LISTINGS ARE UNKNOWN, SINCE BOTH MODELS WERE RETURNED TO THE HOSP. ADD'L EVENT DATE: 1/24/96. (*)
PT READMITTED ON 10/22/95 WITH SHORTNESS OF BREATH AND PROSTHETIC VALVE REGURGITATION. TO OPERATING ROOM  ON 10/23/95 FOR VALVE REPLACEMENT. SAME VALVE WAS USED.
PT ON WALL CPAP WHEN HE WENT INTO RESPIRATORY DISTRESS. HE WAS CODED. BILATERAL PNEUMOTHORACES WERE NOTED. PEEP VALVE WITH ADAPTER WAS NOTED TO BE CONNECTED TO REVERSE FLOW.
AFTER A RIGHT FEMORAL SHEATH WAS PLACED WITHOUT COMPLICATIONS, A RIGHT ARTERIAL SHEATH WAS PLACED. THE DR THEN WENT AHEAD AND TRIED TO FLOAT A CATHETER THROUGH THE RIGHT FEMORAL VENOUS SHEATH. THE DR COULD NOT GET THE CATHETER TO ADVANCE MORE THAN 1" THROUGH THE SHEATH, AND IT FELT THAT THE RIGHT FEMORAL VENOUS SHEATH WAS KINKED. IN SLOWLY INCHING BACK THE VENOUS SHEATH IT SUDDENLY SNAPPED 1" FROM THE HUB AND PART OF IT REMAINED KINKED IN THE RIGHT FEMORAL VENOUS SYSTEM.
WHILE STAFF WAS IN PT ROOM, VENTILATOR STOPPED CYCLING ON IT'S OWN. UNIT WENT INTO APENA ALARM. ON THE VENT, VOLUME AND BREATHES PER MINUTE WERE O (ZERO). NO OTHER ALARMS OR FAILURE INDICATORS ON THE VENT. POWER HAD TO BE RECYCLED ON VENT TO GET IT TO WORK AGAIN. THIS IS THE SECOND TIME THIS VENT HAS DONE THIS. PT'S WEIGHT: 13.8 KG.
CARBON TANK FAILED TO REMOVE CHLORINE. CARBON RESIN DID NOT ABSORB CHLORINE MOLECULES. DIALYSIS HAD TO BE STOPPED ON ALL PATIENTS DUE TO HIGH CHLORINE IN WATER.
THE PT UNDERWENT ESOPHAGOGASTRODUODENOSCOPY ON 12/3/94. A 5 CM BLACK TUBE THAT LOOKED LIKE THE MERCURY TIP FROM A FEEDING TUBE WAS NOTED ALONG THE GREATER CURVATURE OF THE STOMACH. THE TUBE WAS REMOVED USING A SNARE. THE PT HAD PERSISTENT NAUSEA AND VOMITING PRIOR TO THE PROCEDURE.
PT UNDERWENT LEFT TOTAL HIP ARTHROPLATY IN 1993 FOR MARKED DEGENERATION OF HER HIP. SHE DID WELL INITIALLY, BUT CONTINUED TO HAVE PAIN IN THE HIP AND INTO THE GROIN AND SOME SHORTENING OF THAT LEG. SUBSEQUENT X-RAYS SHOWED A LOOSENING OF THE FEMORAL COMPONENT WITH SOME SUBSIDENCE. THE PT WAS ADMITTED FOR REDO OF THAT TOTAL HIP ON THE FEMORAL SIDE WITHOUT REPLACING THE ACETABULAR COMPONENT.
THE PENILE PROSTHESIS FAILED AND EVALUATION REVEALED THAT IT HAD COMPLETE LOSS OF FLUID IN THE SYSTEM. THE PHYSICIAN FOUND A LEAK IN THE RIGHT CYLINDER IN SURGERY. THE SYSTEM WAS REMOVED AND REPLACED. ADD'L SERIAL NO: 72488801.
PT HAD A DUAL CHAMBER PACEMAKER INSERTED IN 1994 AT ANOTHER FACILITY. PT COMPLAINED OF PAIN AND, AT ANOTHER FACILITY, THE GENERATOR WAS PLACED BEHIND THE PECTORALIS MUSCLE TO AVOID STRETCHING THE SKIN. PT CONTINUED TO HAVE PAIN AND WAS ADMITTED HERE FOR EXPLANTATION.
PT HAD PAC INSERTED 10/24/95. STANDARD MAINTENANCE PROTOCOL DONE FOR FLUSHING. PT SEEN IN ONCOLOGY CLINIC 12/14/95. UNABLE TO FLUSH PAC. MD NOTIFIED. UROKINASE INSTILLED AND STILL UNABLE TO FLUSH. "POP" HEARD DURING FLUSH ATTEMPT AND SKIN NOTED TO BULGE AT PAC AREA. SURGEON CONTACTED AND EVALUATED. PT TAKEN TO OR FOR REMOVAL AND REPLACEMENT 12/14/95. SURGEON REPORTED "ONE OF SEPTUMS HAD BECOME DISLODGED FROM THE METAL HOUSING." CO MADE AWARE AND PAC SENT FOR INVESTIGATION.
PT AWOKE AND NOTED A DECREASE IN SIZE OF LEFT BREAST (PREVIOUS LEFT MASTECTOMY DONE AND IMPLANT INSERTED 4/9/92). PT CONTACTED PHYSICIAN'S OFFICE. PT SEEN IN PHYSICIAN'S OFFICE 12/1/95 AND SCHEDULED FOR SURGICAL REMOVAL OF SPONTANEOUS DEFLATED LEFT BREAST IMPLANT. OR PROCEDURE DONE 12/21/95. IMPLANT FOUND TO BE ALMOST TOTALLY EMPTY WITH NO GROSS RUPTURE OR TEAR NOTED. IMPLANT RETURNED TO MFR FOR FURTHER INVESTIGATION.
ON 2/5/96 AT 8:45 AM, DURING TRANSFER OF RESIDENT TO WHEELCHAIR FROM BED VIA PT LIFT THE STRAP BROKE CAUSING RESIDENT TO FALL ONTO FLOOR. RESIDENT SENT TO HOSP. X-RAY DIAGNOSED A FRACTURE OF THE LEFT GREATER TROCHANTER WITH NO NEED FOR SURGERY. TREATMENT: BEDREST.
PT UNDERWENT SURGERY TO REMOVE PROBABLE RUPTURED BREAST PROSTHESIS. BOTH IMPLANTS WERE FOUND TO BE RUPTURED UPON REMOVAL.
PT HAD EROSION OF THE TISSUES WHERE IMPLANT WAS PLACED AND INFECTION. INCONTINENCE.
GASTROSTOMY TUBE CAME APART (WHERE DILATOR CONNECTS W/TUBE) WHEN TUBE WAS BEING PULLED THRU ABDOMINAL WALL.
SUDDEN ONSET OF WHEEZING WITH SEVERE DIFFICULTY BREATHING SOON AFTER WEARING A MASK WHILE TAKING X-RAYS ON A PT WHO WAS ISOLATED FOR TB.
PT UNDERWENT REPAIR OF TOTAL ANOMALOUS PULMONARY VESSEL RETURN (TAPVR). THE SURGERY WAS UNEVENTFUL. POSTOPERATIVELY, PT WAS SLOW TO RESPOND DESPITE REVERSAL OF MUSCLE RELAXANTS. PT DEVELOPED STATUS EPILEPTICUS ON POD AND NEUROLOGICAL STATUS REMAINS IMPAIRED. THERE IS INCREASED INTRACRANIAL PRESSURE.
CHILD UNDERWENT VSD REPAIR. THE PROCEDURE WAS UNREMARKABLE, AND SHE CAME OFF BYPASS WITHOUT DIFFICULTY. WITHIN 1-2 HOURS FOLLOWING COMPLETION OF THE PROCEDURE, THE CHILD EXHIBITED SIGNS OF BRAIN DEATH. SHE EXPIRED 2/6/96. THE PARENTS DECLINED AUTOPSY.
A 59-YR-OLD FEMALE WAS ADMITTED ON 2/6/96 FOR SAME DAY SURGERY TO REMOVE BILATERAL BREAST IMPLANTS, DUE TO PAIN AND CONTRACTURES. SYMPTOMS WERE REPORTED TO BE PRESENT FOR ONE YEAR. THE PT HAD THE INITIAL BREAST IMPLANT IN 1975; THE SECOND BILATERAL IMPLANT IN 1984. THE PT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ON THE SAME DAY. (*)
PT HAD BILATERAL RUPTURE OF SILICONE BREAST IMPLANTS REQUIRING REMOVAL.
PT WAS INVOLVED IN AN AUTO ACCIDENT AND CERVICAL PLATE (C6/7) FRACTURED. (ALSO SEE 1008762).
PT WAS INVOLVED IN AN AUTO ACCIDENT AND CERVICAL PLATE (C6/7) FRACTURED. (ALSO SEE 1008761).
PATIENT STRUCK IN THE BACK OF HEAD WITH A BASKETBALL, CAUSING HEAD TO SNAP FORWARD. SHE EXPERIENCED IMMEDIATE NECK AND INTERSCAPULAR PAIN. X-RAYS SHOWED A FRACTURE OF CERVICAL PLATE WITH OVERLAPPING OF THE INFERIOR AND SUPERIOR PORTION. PATIENT UNDERWENT SURGICAL REMOVAL OF BROKEN PLATE, EXPLORARTION OF C6-7 FUSION AND C4, C5, A AND F. (ALSO SEE 1008764).
PATIENT STRUCK IN THE BACK OF HEAD WITH A BASKETBALL, CAUSING HEAD TO SNAP FORWARD. SHE EXPERIENCED IMMEDIATE NECK AND INTERSCAPULAR PAIN. X-RAYS SHOWED A FRACTURE OF CERVICAL PLATE WITH OVERLAPPING OF THE INFERIOR AND SUPERIOR PORTION. PATIENT UNDERWENT SURGICAL REMOVAL OF BROKEN PLATE, EXPLORARTION OF C6-7 FUSION AND C4, C5, A AND F. (ALSO SEE 1008763).
PT STATED THAT WHEN HE GOES OUT AND GETS AROUND A POWER SUBSTATION IN THE TRANSMISSION LINE, HE TRIES TO CONTROL THE MAGNET BUT IT TURNS ON AUTOMATICALLY. PT SAID THAT IT IS DANGEROUS BECAUSE HE DOES NOT KNOW WHEN THIS IS GOING TO DO IT AND IN WHAT POSITION. PT SUSTAINED 2 INJURIES AND STATED THAT IT IS A SHOCKING FEELING WHEN THE MAGNET INTERFERES WITH THE PROGRAM ON THE STIMULATOR.
VIRTUALLY ALL INJECTABLE MEDICATIONS PRODUCED IN THE UNITED STATES ARE EXPRESSED IN ML (VOLUME). SYRINGES FROM MFR AND SECOND MFR, AND PROBABLY OTHERS, HAVE THE VOLUME EXPRESSED IN CC. THIS CAUSES PROBLEMS WITH PTS AND SOME NURSES WHEN THEY ARE READY TO DRAW UP MEDICATIONS IN SYRINGES. IT WOULD SEEM THAT A CHANGE IN EXPRESSING VOLUME ON SYRINGES IN ML AND NOT CC WOULD BE IN ORDER AND MORE CONSISTENT. (ALSO SEE 1008766).
VIRTUALLY ALL INJECTABLE MEDICATIONS PRODUCED IN THE UNITED STATES ARE EXPRESSED IN ML (VOLUME). SYRINGES FROM ANOTHER MFR AND THIS MFR, AND PROBABLY OTHERS, HAVE THE VOLUME EXPRESSED IN CC. THIS CAUSES PROBLEMS WITH PTS AND SOME NURSES WHEN THEY ARE READY TO DRAW UP MEDICATIONS IN SYRINGES. IT WOULD SEEM THAT A CHANGE IN EXPRESSING VOLUME ON SYRINGES IN ML AND NOT CC WOULD BE IN ORDER AND MORE CONSISTENT. (ALSO SEE 1008765).
THE PT WAS RECEIVING IV GAMMA GARD 20.9 GM IN 418 CC OF SOLUTION TO RUN OVER 6 HOURS. TWO IV BOTTLES CONTAINED 198CC OF SOLUTION AND THE THIRD IV BOTTLE CONTAINED 20CC OF SOLUTION. THE FIRST BOTTLE OF IV SOLUTION INFUSED WITHOUT PROBLEMS. THE SECOND BOTTLE WAS THEN HUNG AND THE IV PUMP WAS SET TO RUN AT 76 CC/HR. THE SECOND BOTTLE WAS STARTED TO INFUSE AT 15:35. AT 16:15, THE PUMP READ THAT 64CC OF SOLUTION INFUSED; HOWEVER, THERE WERE ONLY APROXIMATELY 158CC OF SOLUTION INFUSED INSTEAD OF 64CC. DURING THE INFUSION TIME, THE NURSE DID A PERIODIC VISUAL CHECK OF THE IV BOTTLE AND NOTED NO PROBLEM WITH THE INFUSION RATE. (*)
SINCE NO SAMPLE WAS RECEIVED A DETAILED INVESTIGATION COULD NOT BE PERFORMED. TO REDUCE THE LEAKAGE ISSUE, ICU HAS MADE A RESIN CHANGE TO THE BODY COMPONENT THAT IS MORE RESISTANT TO CRACKING. PRODUCT CONTAINING THE NEW MATERIAL IS CURRENTLY AVAILABLE.
PT HAS TEMPORARY EPIDURAL CATHETER WITH MARCAINE INFUSION VIA MFR'S PUMP WITH REMOTE ADAPTER. EPIDURAL FILTER AND ANOTHER MFR'S CONNECTION. PUMP WILL NOT INFUSE WITH THIS SET UP. ALARMS "HIGH PRESSURE." WHEN CONNECTOR IS REMOVED, IT INFUSES FINE. (ALSO SEE 1008758, 1008759).
PT HAS TEMPORARY EPIDURAL CATHETER WITH MARCAINE INFUSION VIA ANOTHER MFR'S PUMP WITH REMOTE ADAPTER, EPIDURAL FILTER AND A SECOND MFR'S CLAVE CONNECTOR. PUMP WILL NOT INFUSE WITH THIS SET UP, ALARMS "HIGH PRESSURE." WHEN CLAVE IS REMOVED, IT INFUSED FINE. (ALSO SEE 1008757, 1008759).
PT HAS TEMPORARY EPIDURAL CATHETER WITH MARCAINE INFUSION VIA ANOTHER MFR'S PUMP WITH REMOTE ADAPTER. MFR'S EPIDURAL FILTER, AND A THIRD MFR'S CONNECTION. PUMP WILL NOT INFUSE WITH THIS SET UP. ALARMS "HIGH PRESSURE." WHEN CONNECTOR IS REMOVED, IT INFUSES FINE. (ALSO SEE 1008757, 1008758).
PHYSICIAN LEANED ON HEADREST AND HEADREST PARTIALLY RELEASED, EXTENDING THE PT'S HEAD (NOT PAST 45 DEGREES) BED TESTED BEFORE NEXT CASE AND IT WAS SECURE. NO PROBLEMS DURING THAT CASE. HOWEVER, AFTER THE CASE EXTRA PRESSURE WAS APPLIED AND THE HEADREST EXTENDED ABRUPTLY TO 90 DEGREES WITH PIECES FALLING ON THE FLOOR. NO KNOWN INJURIES. SENT TO BE REPAIRED. NOTE: THIS IS RPTR'S SIMILAR INCIDENT IN ABOUT 6 MONTHS WITH TWO DIFFERENT BRANDS OR BEDS.
INFUSION SET SNAPPED OFF AT ENTRANCE TO INFUSION PUMP MECHANISM. FLUOROURACIL LEAKED ONTO COUNTER OF PATIENT'S KITCHEN AND ONTO CARRYING POUCH USED WITH MFR'S PUMP. PT DENIES MISHANDLING DEVICE OR CATCHING TUBING ON ANYTHING.
THE ENCLOSED LETTER REFERENCING MW1008773 WAS SENT TO CO'S ATTENTION FOR INFO REGARDING A MEDWATCH REPORT. CO FORWARDED THE LETTER ON TO THE MFR, ARROW INTL, INC.
AT THE END OF 5/95, RPTR FOUND HERSELF IN THE EMERGENCY ROOM IN ANAPHYLACTIC SHOCK DUE TO LATEX SENSITIVITY. IN RETROSPECT, THE HAND DERMATITIS WHICH BEGAN ABOUT SIX YEARS AGO, WAS PROBABLY RELATED. SHE IS UNABLE TO WORK ANY MORE.
IN 1985 PT UNDERWENT BREAST RECONSTRUCTION FOLLOWING LEFT MODIFIED RADICAL MASTECTOMY AND RIGHT SUBCUTANEOUS MASTECTOMY WITH PLACEMENT OF SILICONE BREAST IMPLANTS BILATERALLY. FOLLOWING THIS SURGERY, PT HAS DEVELOPED INCREASED PAIN AND DISCOMFORT AND A BAKERS IV, GRADE IV CAPSULAR, CONTRACTURE ON THE LEFT, AND A BAKER'S GRADE III CAPSULAR CONTRACTURE ON THE RIGHT, HAS DEVELOPED "SYMPTOMATIC" PAIN AND DISCOMFORT, AND IS UNABLE TO MOVE HER LEFT ARM AND SHOULDER TO BRUSH HER HAIR SECONDARY TO THIS DISCOMFORT. SHE ALSO DEVELOPED A NEW MASS OVER THE RIGHT BREAST IMPLANT. IMPLANTS REMOVED 3/20/96 AND REPLACED WITH SALINE IMPLANTS.
CHILD WAS IN THE OPERATING ROOM FOR SURGERY TO REPAIR CONGENITAL HEART DEFECT. A 10 FRENCH FOLEY CATHETER WAS PLACED INTO THE PT'S BLADDER AND INFLATED WITH 3 CC OF FLUID. THE CATHETER SLIPPED OUT OF THE BLADDER, AND IT WAS NOTED THAT THE BALLOON WAS BROKEN AND THE TIP OF THE CATHETER HAD BROKEN OFF AND REMAINED IN THE PT'S BLADDER. IF THE CHILD DOES NOT SPONTANEOUSLY PASS THE CATHETER TIP, SURGERY WILL BE NECESSARY TO REMOVE IT.
RUPTURE OF LEFT BREAST IMPLANT REQUIRING SURGICAL REMOVAL AND RESECTION OF SILICONE GRANULOMA REACTION TO LEFT BREAST.
RESIDENT WAS FOUND IN HIS ROOM WITH HIS LEGS EXTENDED TO THE FLOOR AND UPPER TORSO IN SEAT OF WHEELCHAIR. THE QUICK RELEASE SEAT BELT ATTACHED TO THE WHEEL CHAIR WAS FOUND ACROSS HIS NECK. RESIDENT WAS IMMEDIATELY RELEASED FROM SEATBELT WHEN FOUND AND LOWERED TO THE FLOOR. HIS COLOR WAS PALE AND ASHEN WITH NO VITAL SIGNS.
SLOW PULSE RATE DISCOVERED DURING PERSATINE SESTAMIBI STRESS TEST ON 3/8/96. PACEMAKER EVALUATION THE SAME DAY SHOWED DECREASED LEAD IMPEDANCE AND INTERMITTENT LOSS OF SENSING AND LOSS OF CAPTURE IN THE VETRICLE. CHEST FILM UNREMARKABLE. MALFUNCTION CONFIRMED ON 3/15/96. LEAD ABANDONED AND REPLACED AT A MEDICAL CENTER ON 3/18/96.
RPTR RECEIVED ELECTRIC SHOCK THERAPY FROM A PSYCHIATRIST. SHE TRIED TO COMMIT SUICIDE AFTERWARDS, LOST HER HUSBAND AND HER HOME. NOW HAS PERMANENT, IRREVOCABLE MEMORY LOSS OF EVENTS IN THE PAST, AND DIFFICULTY WITH SHORT TERM MEMORY. SHE HAS DEVELOPED SINCE THAT TIME A SEIZURE DISORDER WHICH HAS BEEN ATTRIBUTED TO SHOCK THERAPY. SHE COMPLAINS THAT SHE IS NOW AGORAPHOBIC, AND STILL SEVERELY DEPRESSED. SHE HAS LOST HER COLLEGE EDUCATION. SHE HAS BEEN UNABLE TO WORK SINCE THAT TIME, AND IS ON DISABILITY.
PT HAD ONSET OF WHEEZING THE BEGINNING OF 1995. SHE NOTICED PROBLEMS AFTER WORKING A DAY OR TWO IN A ROW. BY THE SECOND DAY SHE WAS HAVING SOB AND PAINS IN CHEST. SHE IS USING AN INHALIS AT WORK. SHE IS ALSO HAVING ITCHING OF HER HANDS WITHOUT A RASH. SHE HAS TAKEN OFF WORK, SYMPTOMS WENT AWAY AND PEAK FLOWS WERE NORMAL. SHE RETURNED TO A LATEX-FREE UNIT IN 1/96. NO ONSET OF PROBLEMS.
EMPLOYEE BEGAN FEELING BRONCHOCONSTRICTION WITH SOB AND CONGESTION AFTER ANOTHER EMPLOYEE TOOK GLOVES FROM A CONTAINER IN FRONT OF HER. SHE USED INHALER WITH MINIMAL RELIEF. ONE HOUR LATER, SHE BECAME EXTREMELY SOB AFTER PUTTING ON COTTON LINERS AND GLOVES. SHE USED INHALER WITHOUT RELIEF. ON 10/13/94 SHE SHOOK OUT COTTON LINERS AT HOME BEFORE WASHING THEM AND DEVELOPED BRONCHOCONSTRICTION - TREATED IN ER.
RPTR HAD BREAST IMPLANTS PLACED 2/78. SHE HAD A TOTAL OF 3 BREAST SURGERIES ON THE LEFT AND 2 ON THE RIGHT. SHE HAD NUMBNESS IN THE SURGICAL AREA BILATERLLY AND LEFT HEMATOMA. THE LEFT IMPLANT RUPTURED. SHE C/O HIGH BLOOD PRESSURE, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, CARPAL TUNNEL SYNDROME, MOTOR NEURON DISEASE, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ORGANIC BRAIN SYNDROME, CHEST/RIB CAGE: PAIN &/OR BURNING SENSATION AND INFLAMMATION, ELEVATED CHOLESTEROL AND TRIGLICERIDES, SUPERIOR OBLIQUE TENDONITIS OF EYES, CHRONIC SWELLING, PAIN DISCOLORATION (RED AND BLUE) COLD SENSITIVITY OF EXTREMITIES, RAYNAUD'S PHENOMENON FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, DUODENITIS, IRRITABLE BOWEL SYNDROME, GASTROINTESTINAL MOTOR DYSFUNCTION, CHRONIC YEAST INFECTIONS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATION, FREQUENT SEVERE HEADACHES, PALPATATIONS/TACHYCARDIA,  HYPERSENSITIVITY OR ALLERGIES TO: CHEMICALS, MOLDS, DUST OR POLLEN, ATYPICAL LUPUS, JOINT INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, PERSISTENT JOINT STIFFNESS, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER BILATERALLY, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, MYOSITIS OR POLYMYOSITIS, HYPER REFLEXIA, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, CLUMSINESS/DROPS THINGS, MISJUDGES DISTANCE/RUNS INTO OBJECTS, AND SICCA.(*)
PT IN CATH LAB. FOLLOWING SUCCESSFUL ANGIOPLASTY, PT'S HEART RHYTHM CHANGED TO VENTRICULAR FIBRILLATION REQUIRING DEFIBRILLATION. DEFIBRILLATOR WOULD NOT CHARGE.
PT IN CATH LAB. PT EXPERIENCED V-TACH DURING CONSTRAST INJECTION. PT NEEDED DEFIBRILLATION. DEFIBRILLATOR WOULD NOT CHARGE. BIOMED CHECKING EQUIPMENT, CONSULTING WITH CO.
REMOVAL OF PENILE PROSTHESIS. CORPORAL RUPTURE. PROSTHESIS WORKED FINE.
PT HAD IOL INSERTED FOLLOWING CATARACT SURGERY IN 1977. THE PT HAD A PENETRATING KERATOPLASTY IN 1992. NOW PRESENTS WITH HAZY VISION AND GRAFT REJECTION. INTRAOCULAR LENS REMOVED AT THE TIME OF SURGERY FOR REPEAT PENETRATING KERATOPLASTY.
THE PT HAD ENOPHTHALMOS, IRRITATION, DISCHARGE AND RIGHT LOWER LID ENTROPION FOLLOWING REPAIR OF OPEN GLOBE AND OCULAR IMPLANT 4-5 YERS AGO.
THE PT HAD CATARACT EXTRACTION WITH IOL INSERTION IN 6/95. THIS WAS FOLLOWED BY A SURGERY IN 10/95 FOR RETINAL DETACHMENT AND PROLIFERATIVE VITREORETINOPATHY. THE PT IS ADMITTED FOR RETINAL DETACHMENT AND REMOVAL OF THE INTRAOCULAR LENS WHICH WAS INSERTED IN 6/95. ADMISSION IS 2/2/96.
THE PT HAD CATARACT EXTRACTION WITH INSERTION OF INTRAOCULAR LENS, DATE UNKNOWN. PRESENTS WITH DISLOCATION OF LES AND VITREOUS OPACITIES. INTRAOCULAR LENS WAS REMOVED AND REPLACED.
PICC LINE SEPARATED DURING PLACEMENT. HAD TO BE REMOVED UNDER FLUOROSCOPY.
THE CYLINDER ERODED THROUGH THE TISSUE AND WAS REMOVED, THE PUMP TUBING WAS CAPPED OFF.
REMOVAL OF PENILE PROSTHESIS DUE TO EXTRUSION (EROSION).
THE PT WAS BEING OBSERVED DURING IMMEDIATE POST-CLOSURE OPEN HEART SURGERY. PT WENT INTO VENTRICULAR FIBRILLATION. EXTERNAL STERILIZED PADDLES WERE IMPROPERLY PLUGGED INTO DEFIBRILLATOR, AND DEFIBRILLATION WAS NOT IMMEDIATELY AVAILABLE. CHEST COMPRESSIONS WERE INITIATED WHILE PADDLES WERE RE-PLUGGED IN PROPERLY. PT WAS DEFIBRILLATED AND THE CHEST WAS RE-OPENED. THE PT WAS GIVEN A BOLUS OF EPINEPHRINE, AND RETURNED TO NORMAL SINUS RHYTHM. THE PT SURVIVED THE EVENT.
A LEADED GLASS X-RAY SHIELD, CEILING MOUNTED ON A ROTATING ARM, WAS BROKEN AS A CATH LAB C-ARM WAS ROTATING INTO POSITION. GLASS SHATTERED OVER PATIENTS FACE AND CAUSED A LACERATION.
IMPLANT WAS CULTURED PRIOR TO IMPLANT JUST AFTER LID OF PRODUCT WAS OPENED. SENT TO LAB DIRECTLY. PRODUCT WAS USED IN A 43 YR-OLD WOMAN WHO UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION-TIBIAL PLATEAU LEFT LEG. ON 2/6 SURGEON WAS NOTIFIED THE SPECIMEN GREW STAPHYLOCOCUS EPIDERMIDIS.
PATIENT WAS ADMITTED TO HOSP ON 10/8/93 WITH FRACTURED HIP. A PLATE AND SLIDING SCREW WAS USED TO STABILIZE FRACTURE. THE SLIDING PART OF THE SCREW DID NOT SLIDE AND THE PHYSICIAN REPORTS IT WAS CORODED UPON REMOVAL (7/18/95) BECAUSE OF THE NON-SLIDE BY THE DEVICE. THE PATIENT HAS ONE LEG ABOUT 1" LONGER THAN THE OTHER.
PT HAD TONUS STIMULATOR IMPLANTED 1977, ONE YEAR AFTER MOTOR VEHICLE ACCIDENT. STATES IT NEVER WORKED AND TO HIS KNOWLEDGE HAS ONLY EVER WORKED FOR ONE PERSON. PT STATES MD IMPLANTED WRONG SIZE ELECTRODE AND IN WRONG PLACE. THE TEFLON BLADDER ENVELOPE HAS ADHERED TO HIS BLADDER AND CANNOT BE EXPLANTED WITHOUT "AMPUTATING" HIS BLADDER. TEFLON HAS MIGRATED THROUGH HIS BODY. OVER TIME HE HAS DEVELOPED ALMOST COMPLETE INCONTINENCE AND DAMAGE TO HIS SEX LIFE. HE SUFFERS WITH BACK PAIN AND ARTHRITIS AS WELL. STATES MFR CLAIMS THE STATUTE OF LIMITATIONS HAS ELAPSED. THE HOSP CAN'T FIND HIS RECORDS AND "ALL THE ATTORNEYS REFUSE TO HELP HIM."
STAPLER WITH THE ORIGINAL STAPLE CARTRIDGE WOULD NOT FIRE DURING A VAGOTOMY DESPITE CORRECT CLOSURE OF THE INSTRUMENT.
DURING PARTIAL THYROIDECTOMY OR PENCIL WOULD NOT OPERATE ON FIRST ATTEMPT TO USE BY THE DOCTOR. PENCIL REPLACED AND WORKED FINE.
DURING THE BALLOON DILATION PHASE OF ERCP, THERE WAS A SUDDEN LEAK IN THE PRESSURE IN THE BALLOON. THERE WAS EXTRAVASATION OF STERILE SALINE INTO THE DORSAL DUCT AND THE PT DEVELOPED ACUTE PANCREATITIS.
IOL FOLDED. HAPTIC INSERTED INTO FOLD. LENS FLIPPED OUT OF HOLDER & HAPTIC BROKE.
VALVE FROM AMBU BAG TO PRESSURE GAUGE IS BROKEN OFF AT AMBU BAG. PIECE OF PLASTIC IS BROKEN RIGHT OFF.
IN MAY, THE DEVICE INVOLVED WAS EXAMINED BY CO'S SALES REP. DURING THE REP'S VISIT, THE ALLEGED INCIDENT COULD NOT BE DUPLICATED. AS A GOODWILL GESTURE, THE WHEELCHAIR IS BEING REPLACED. RESPONSE TO REQUEST: TO DATE, THE MFR HAS BEEN UNABLE TO DUPLICATE THE DESCRIBED INCIDENT. THIS MAKES THE ANALYSIS AND TESTING INFO WHICH RPTR HAS REQUESTED IMPOSSIBLE TO OBTAIN. CO CURRENTLY PRODUCES OVER 100,000 WHEELCHAIRS PER YEAR OF THIS TYPE AND HAVE NOT BEEN NOTIFIED OF ANY SIMILAR REPORTS. THIS IS A MANUAL WHEELCHAIR WITH NO POWER SOURCE OR ELECTRICAL COMPONENTS. CO'S DESIGN ENGINEERS HAVE BEEN CONSULTED REGARDING THIS INCIDENT AND KNOW OF NO CIRCUMSTANCES WHICH COULD LEAD TO THIS TYPE OF INCIDENT. CO'S CONCLUSION IS THAT CO IS UNABLE TO EXPLAIN THE CAUSE OF THE ALLEGED INCIDENT. ALSO, CO IS NOT AWARE OF A MALFUNCTION WHICH COULD LEAD TO AN INCIDENT AS DESCRIBED. THEREFORE, CO BELIEVES NO FURTHER ACTION IS NECESSARY AND CONSIDER THIS ISSUE RESOLVED.
3/13/96 PT CALLED TO STATE HER 7" EXTENSION SET CRACKED WHERE IT IS CONNECTED TO A PATIENT UNABLE TO FLUSH DUE TO FLUID AND BLOOD ESCAPING FROM CRACKED SITE. 3/27/96 7" EXTENTION SET CRACKED WHEN A 10CC LUER-LOCK SYRINGE WAS ATTACHED TO FLUSH AFTER A BLOOD DRAW. BLOOD WAS SPLATTERED ON THE NURSE. THE SYRINGE MFR WAS NOTIFIED IN 1995 THAT EXTENSION SETS FROM MFR WERE CRACKING WHEN ATTACHED TO EXTENSION SETS. THE SYRINGE MFR INVESTIGATED AND FOUND THEM TO BE COMPATIBLE IN SIZE.
MD REPORTED THAT STYLET FROM QUAD LUMEN KIT WAS "ROUGH" AND THAT IT REQUIRED CUTTING IN ORDER FOR INSERTION TO BE COMPLETED.
RPTR WAS TEACHING STERILE TECHNIQUE TO NURSING STUDENTS USING LATEX GLOVES AND HER EYES SWELLED SHUT. THEN SHE WAS AT THE DENTIST'S OFFICE GETTING HER TEETH EXAMINED AND AGAIN SHE HAD DIFFICULTY BREATHING AND HER EYES SWELLED. BLOOD WAS DRAWN THE SAME DAY AND IT CAME BACK 1+ FOR LATEX ALLERGY.
RPTR WAS TEACHING STERILE TECHNIQUE TO NURSING STUDENTS USING LATEX GLOVES AND HER EYES SWELLED SHUT. THEN SHE WAS AT THE DENTIST'S OFFICE GETTING HER TEETH EXAMINED AND AGAIN SHE HAD DIFFICULTY BREATHING AND HER EYES SWELLED. BLOOD WAS DRAWN THE SAME DAY AND IT CAME BACK 1+ FOR LATEX ALLERGY. (ALSO SEE 1008795).
A 79-YR-OLD MALE ADMITTED WITH CARDIOMYOPATHY. PT WAS BEING MONITORED BY TELEMETRY. TRANSMITTER BATTERY WAS CHARGED 45 MINUTES PRIOR TO ARRIVAL. INFO FROM MONITOR AT CENTRAL STATION INDICATED "WAVE INVALID-BATTERY RANGE." NURSE FOUND PT UNRESPONSIVE AND A CODE WAS CALLED. ATTEMPTS AT RESUSCITATION WERE UNSUCCESSFUL.
PT FOUND DEAD WEDGED BETWEEN UPPER AND LOWER BED SIDE RAILS. INCIDENT IS UNDER INVESTIGATION. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.
THE PATIENT UNDERWENT A THIRD BYPASS SURGERY FOR UNSTABLE ANGINA. A BALLOON WAS INSERTED IN SURGERY AFTER THE BYPASS AT ABOUT 1300. INITIALLY AN UNUSUAL, MORE SQUARE WAVEFORM WAS NOTED SO THE BALLOON WAS WITHDRAWN SLIGHTLY AFTER WHICH NORMAL PUMPING WAVEFORMS WERE OBTAINED. THE PATIENT WAS TRANSFERRED TO CCU WITH THE BALLOON PUMP REPORTED AS WORKING FINE. THE GAS LOSS ALARM WAS NOTED ONCE IN THE EARLY EVENING. AT ABOUT 2330 LOSS OF PUMPING WAS REPORTED WITH RESPONSE FROM PHYSICIANS AND NURSES INVOLVED. BY 2345 THE PATIENT WAS DETERIORATING, PLANS WERE MADE TO RETURN TO SURGERY AND EFFORTS INITIATED TO REMOVE THE BALLOON. THE BALLOON COULD NOT BE REMOVED; THE CONNECTION END WAS CUT OFF TO ASSURE DEFLATION AND A CUT DOWN TO THE ARTERY AND EXCESSIVE FORCE THE BALLOON CAME FREE WITH A SLEEVE OF INTIMA APPROXIMATELY 7 CM LONG. THE PATIENT COULD NOT BE STABILIZED FOR SURGERY AND EXPIRED AT ABOUT 0030 PM ON THE 11TH.
CATHETER WAS PLACED WITHOUT PROBLEM. GOOD PA WAVE FORM. CATHETER WAS FLOATED TO WEDGE POSITION. BALLOON WAS DEFLATED. PATIENT DEVELOPED HEMOPTYSIS. NO AGGRESSIVE RESUSCITATION DUE TO DNR/DNI STATUS.
CATHETER PLACED WITHOUT COMPLICATION. LATER MEASURE OF PA PRESSURE AND CVP WERE DONE. PA TRACING APPEARED TO BE PULMONARY ARTERY PRESSURE TRACING. PT C/O SOMETHING IN HER THROAT, BEGAN COUGHING UP BLOOD, BLEEDING CONTINUED. RESUSCITATION EFFORTS WERE UNSUCCESSFUL.
VEST RESTRAINED PATIENT FOUND ON FLOOR AT BEDSIDE WITH RESTRAINT STRAP AROUND NECK. PATIENT EXPIRED.
THE PT WANTS TO MAKE HER INFORMATION AVAILABLE TO FDA, MFRS, AND OTHER RESEARCHERS. SINCE HAVING IMPLANTS PLACED IN 1980, THE RPTR HAS HAD NUMEROUS SURGERIES AND MEDICAL PROBLEMS TO INCLUDE: CAPSULAR CONTRACTURES, HARDENING OF THE IMPLANTS, RUPTURE OF THE IMPLANTS WITH MIGRATION OF SILICONE INTO HER LYMPH NODES AND "EVERYWHERE" RECURRENT. SKIN INFECTION WITH A YEAST FUNGUS-CRYPTOCOCCUS ALBIDUS REQUIRING NUMEROUS SKIN BIOPSIES, RHEUMATOID ARTHRISTIS, REQUIRING NUMEROUS SURGERIES: FINGER AND TO FUSIONS, SYNOVIECTOMY, ARTHROSCOPIES, BUNIONECTOMIES AND RIGHT KNEE REPLACEMENT, CERVICAL HPV, AND SALPINGO-OOPHORECTOMY.
RPTR C/O PAIN AND JOINT TENDERNESS, IN ARMS, CHEST AND HIP; SJOGRENS; 100 DEGREE FEVER AND POSITIVE ANA - 250 DILUTION; 10/2 CO SILICONE-GEL ONE IMPLANT BECAME SWOLLEN, YELLOW AND FILLED WITH BODY FLUIDS; OOZING SILICONE EVIDENCED WHEN IMPLANT REMOVED IN 1993. IMPLANT MIGRATED TO ARMPIT AND WAS SEVERELY DETERIORATED. RPTR HAS INNUMERABLE DOCTORS RECORDS OF TENDONITIS, COSTOCHONDRITIS, FEVER, DRY EYES AND SCHIRMER'S, FOLLOWING IMPLANTATION WITH IMPLANTD IN 1989 WITH EXPLANTATION IN 1993. SOME PROBLEMS CONTINUE.
RPTR HAS DEVELOPED MULTIPLE MEDICAL PROBLEMS, INCLUDING MEUROLOGICAL DISORDERS, MENTAL IMPAIRMENT, DRY EYES 2 YEARS AFTER IMPLANTS, PAIN, WEAKNESS, BILATERAL CATARACTS AT AGE 48, ALLERGIES AND MANY MORE. IMPLANTS WERE RUPTURED.
ROUND GEL BREAST IMPLANTS PLACED IN 10/78. PT DID NOT REALIZE RUPTURE HAD OCCURRED AND NONE OF THE MAMMOGRAMS SHOWED THE RUPTURE. OPERATIVE REPORT STATES RIGHT IMPLANT WAS AN INTRACAPSULAR RUPTURE AND LEFT IMPLANT WAS RUPTURED AT TIME OF EXPLANT. PT NOW HAS ANA TITER OF 1:320 AND ATYPICAL CONNECTIVE TISSUE DISEASE.
THE GRADUATION INKING IS NOT COMPLETE. THERE ARE VOIDS IN THE ACTUAL INKING WHICH COULD CAUSE USE ERROR.
THE BLACK RUBBER DIAPHRAGM IS NOT LEVEL. THIS CAUSES PROBLEMS WITH READING THE GRADUATIONS. THERE IS A DIFFERENCE OF .1 - .2CC. RPTR HAS FOUND SEVERAL SYRINGES IN THIS PARTICULAR GROUP WITH THIS PROBLEM.
PATIENT ANESTHETIZED AND INTUBATED. HEAD OF TABLE RELEASED WITHOUT ANYONE RELEASING THE GEARS. PT'S HEAD HYPEREXTENDED. PT REQUIRED X-RAY AND AN COLLAR. NO KNOWN INJURY.
PATIENT FOUND WITH TRACH DISCONNECTED FROM VENTILATOR. PT RESUSCITATED AND TRANSFERRED TO ICU. SEVERAL HOURS LATER, PT ARRESTED, WAS CODED AND EXPIRED, VENTILATOR MFR WAS NOTIFIED. INITIAL INVESTIGATION REVEALED VOLUME CONTROL ON ALARM TO BE MALFUNCTIONING.
HIT MACHINE IN USE; PATIENT HEARD "POP"  AND SMELLED SMOKE. PT STATES HE UNMPLUGGED MACHINE. PT STATES HE FELT NO SHOCK OR INJURY.
LENS HAPTIC BROKE DURING INSERTION OF IOL.
IN 1973, RPTR HAD A BREAST IMPLANT IMPLANTED. AFTER 10 YEARS, PT STARTED TO DEVELOP ARTHRITIS AND, AT THE AGE OF 30, IT BECAME SEVERE. IN 1987 PTS CONDITION CONTINUED TO WORSEN. DR HAD NO EXPLANATION FOR THE CHRONIC ARTHRITIC CONDITION WHICH REQUIRED HOSPITALIZATION. IN 1992 PT DEVELOPED SHINGLES. PT WAS NEVER ADVISED OF THE POSSIBILITY OF AUTOIMMUNE DISORDER ASSOCIATED WITH THE LEAKING OF THE IMPLANT. MANY SPECIALISTS BEGAN TO INDICATE THAT PT'S AUTOIMMUNE DISORDER WAS CAUSED BY THE LEAKING IMPLANT. PT DEVELOPED BLISTERS ON THE RIGHT BREAST AND DR RECOMMENDED THE IMPLANT BE REMOVED. PRIOR TO THE IMPLANT BEING REMOVED, A BLOOD TEST WAS PERFORMED WHICH REVEALED A HIGH ABNORMAL ANA. THE IMPLANT WAS REMOVED IN 1993. AFTER THE SURGERY PT HAD LUPUS-LIKE SCARS ON HER NECK AND FACE AND HER BODY BECAME "INFLAMMED." THE SURGEON REMOVED THE SCAR TISSUE FROM PT'S ARMPIT. IT WAS LATER DETERMINED THAT THE IMPLANT RUPTURED AND HAD LEAKED INTO THE SURROUNDING TISSUE. THE DR REPORTED THAT THE BLOOD TEST AFTER THE IMPLANT REMOVAL WAS NORMAL AND REVEALED THAT THE ANA LEVEL HAD RETURNED TO NORMAL. DR INDICATED THAT THIS WAS PROOF THE IMPLANT HAD CAUSED THE AUTOIMMUNE DISORDER. PT'S ILLNESS HAS CAUSED HER FINANCIAL, PHYSICAL AND MENTAL DISTRACTION. PT HAS SEVERAL LAB RESULTS REVEALING THE DAMAGE FROM THE DEFECTIVE BREAST IMPLANT. PT HAS EXPERIENCED ONGOING PROBLEMS OBTAINING APPROPRIATE MEDICAL TREATMENT AND HER CONDITION CONTINUES TO DETERIORATE. MANY DOCTORS HAVE SAID THAT NOT ENOUGH INFO IS AVAILABLE TO HELP THEM KNOW HOW TO TREAT PTS ILLNESS PLEASE HELP THE SICK WOMEN BEFORE THEY DIE.
NURSE USING NON-STERILE/POWDERED GLOVES FOR INFECTION CONTROL POLICY IN THE HEALTH CARE PRACTICE. SHE HAS PROGRESSIVE DERMATITIS EVEN AFTER SWITCHING TO NON-POWDER/NON-STERILE GLOVES.
RPTR HAD BREAST IMPLANTS PLACED IN 1978. SHE HAD CALCIUM DEPOSITS. IN THE SURGICAL AREA SHE HAD INFECTION, HEMATOMA, EXCESS FLUID AND NUMBNESS. THE IMPLANTS WERE RUPTURED, SHE HAD BLEEDING THROUGH THE ENVELOPE AND ONE CAPSULAR CONTRACTURE. SHE IS REPORTING ONE MONTH AFTER EXPLANTATION SHE C/O PERIPHERAL NEUROPATHY, OTHER NEUROPATHY, BRAIN LESIONS, ANXIETY &/OR LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, STROKE (MRI REVEALS A SERIES OF MINI-STROKES) HEAT OR COLD SENSITIVITIES OF FEET, SUBSTANTIAL HAIR LOSS ON LEGS, PALPITATIONS, CONNECTIVE TISSUE DISEASE, ATYPICAL LUPUS, EXERCISE-INDUCED ASTHMA AFTER IMPLANTS, CHRONIC FATIGUE SYNDROME WHICH IS IMPROVING. SINUS PROBLEMS AND BUNION PROBLEMS AFTER IMPLANTS.
RPTR'S HOSP BEGAN USING THE CATHETER IN 1992 OR 1993 BUT DID NOT START TRACKING EACH CATHETER INSERTION UNTIL END OF 1993. THE HOSP ALSO HAS A HOME CARE AGENCY WHICH USES THE CATHETERS. FROM 9/93 TO 12/95. 1999 WERE INSERTED IN THE HOSP. RPTR DOES NOT HAVE ANY DATA ON THE LINES INSERTED BY THE HOME CARE CO. DURING THE ABOVE TIME PERIOD, THERE WERE 5 REACTIONS IDENTIFIED AT THE TIME OF INSERTION. THREE OF THE REACTIONS OCCURRED IN THE SAME PT ON THREE DIFFERENT INSERTIONS OVER A 2-YEAR PERIOD OF TIME. THE REACTION IN THE SECOND PT MAY HAVE BEEN ANXIETY-RELATED RATHER THAN CATHETER RELATED. THE THIRD PT HAD A SEVERE REACTION REQUIRING TRANSFER TO INTENSIVE CARE BUT STABILIZED AND WAS TRANSFERRED OUT OF ICU IN 24 HOURS. OVER THE FIRST TWO MONTHS OF 1996, APPROXIMATELY 60 CATHETERS HAVE BEEN INSERTED AND ONE INSERTION REACTION WAS NOTED. APPROXIMATELY 10 MINUTES AFTER INSERTION, THE PT DEVELOPED ITCHING AND HIVES ALL OVER HIS BODY. THERE WAS NO HYPOTENSION OR BREATHING PROBLEMS DOCUMENTED. THE PT WAS GIVEN BENADRYL AND THE REACTION RESOLVED. THE CATHETER WAS LEFT IN PLACE AND WAS USED FOR 1 MONTH WITHOUT ANY FURTHER REACTION.
RPTR'S THE HOSP ALSO HAS A HOME CARE AGENCY WHICH USES THE CATHETERS. APPROXIMATELY 1 YEAR AGO, RPTR'S FACILITY BEGAN USING PICC. APPROXIMATELY 15 OF THESE CATHETER'S HAVE BEEN INSERTED AND 1 INSERTION REACTION WAS REPORTED. ABOUT 2 MINUTES AFTER INSERTION, THE PT BECAME DIAPHORETIC, FLUSHED, AND HYPOTENSIVE. THE CATHETER WAS PULLED OUT AND THE PT TRANSFERRED TO ICU. THE EPISODE RESOLVED WITHOUT FURTHER COMPLICATIONS. THREE DAYS LATER, ONE OF RPTR'S VASCULAR SURGEONS INSERTED ANOTHER PICC INTO THE SAME PAT WITHOUT ANY REACTION; HOWEVER, THE PT WAS GIVEN SOME TYPE OF PRE-MEDICATION (?ATIVAN).
IT APPEARS THAT THE DEPOT SYSTEM OR MFRS ARE MISLABELING A PRODUCT WITH THE NATIONAL STOCK NUMBER. THE ITEM IDENTIFIED IN ENCLOSURE 1 IS LABELLED WITH THE NATIONAL STOCK NUMBER INDICATED ON ENCLOSURE 2. HOWEVER, THE SPECIFICATIONS LISTED ON ENCLOSURE 1 MATCH THE CATALOG SPECIFICATIONS LISTED IN ENCLOSURE 3 FOR ANOTHER NATIONAL STOCK NUMBER (EXCEPT FOR THE UNIT OF MEASURE QUANTITY, WHICH MAY BE A CATALOGING ERROR). CUSTOMERS COMPLAIN THAT THE MATERIAL, IDENTIFIED BY ENCLOSURE 1 FOR THE SUBJECT NATIONAL STOCK NUMBER, CLOGS THEIR SUCTION DEVICES BECAUSE IT IS TOO SMALL. THEY THINK THEY ARE SUPPOSED TO GET MATERIAL WITH A HALF INCH DIAMETER AND THE MATERIAL IDENTIFIED BY ENCLOSURE 1 IS ONLY 3/8 INCH DIAMETER. ENCLOSURE 5 SHOWS A LABEL FROM A CORRECTLY MARKED BOX OF MATERIAL. (*)
LANCETS IN 2 SEPARATE BOXES HAVE 2 DIFFERENT SIZE BASES. LANCETS FROM ONE BOX WILL FIT INTO FINGER PRICKING DEVICE; LANCETS FROM ANOTHER BOX WILL NOT FIT INTO THE DEVICE. ALTHOUGH THE LANCETS DIFFER, EACH BOX BEARS THE SAME LOG NUMBER.
WHITE PARTICULATE MATTER ON ATTACHED 22GA 1 1/2" NEEDLE. THIS SYRINGE WAS OPEN. THE CAP WAS SEALED. UPON TAKING THE SYRINGE OUT OF THE CASING AND REMOVING THE NEEDLE COVER, DR NOTICED THE NEEDLE HAD SOME WHITE SPOTS ON IT. THE NEEDLE WAS CAPPED, THE SYRINGE AND NEEDLE PLACED BACK INTO THE CASING. DR WANTS A REPORT BACK AS TO WHY AND WHAT WAS THE WHITE SUBSTANCE.
PT UNDERWENT CATARACT EXTRACTION WITH LENS IMPLANT IN LEFT EYE. LENS BROKE IN PT'S EYE. BROKEN LENS WAS REMOVED AND A NEW ONE WAS INSERTED.
RPTR RECEIVED A CALL FROM AN RN, WHO BROUGHT THE PROBLEM TO HIS ATTENTION, THE COMPLAINT HAD TO DO WITH THE ONE-WAY VALVE ASSEMBLY BETWEEN THE MASK AND HIGH CONCENTRATOR BAG. APPARENTLY THE VALVE STICKS SHUT.
BLACK INK MARKS NOTICED ON THE BOTTOM OF THE SYRINGE, AND ON THE INNER PART OF THE WRAPPER.
PT IN OR FOR D&C FOLLOWED BY VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, CULDOPLASTY, CYSTOURETHROCELE AND RECTOCELE REPAIR AND PERINEORRAPHY. DURING FINAL STAGE AN ATTEMPT WAS MADE TO PUT A FOLEY CATHETER INTO THE BLADDER. 300CC OF METHYLENE BLUE-TINGED WATER WAS PUT IN AND AN ATTEMPT WAS MADE TO INSERT THE SUPRAPUBIC CATHETER INTO THE BLADDER. HOWEVER, THE METHYLENE BLUE COULD NOT BE DRAINED OUT. A CYSTOSCOPY DISCLOSED A FALSE SPACE CREATED IN THE URETHRA. THE CATHETER WAS REMOVED AND REINSERTED WITHOUT SERIOUS ADVERSE IMPACT ON THE PT. UROLOGIST CONSULTED; CYSTOSCOPY PERFORMED; NEW SUPRAPUBIC CATHETER INSERTED.
CONFUSED PT WAS FOUND ON THE FLOOR BY NURSING PERSONNEL COVERED IN BLOOD. PT'S ARM WAS BEING SUPPORTED AND ELEVATED WITH IV POLE. PT WAS BLEEDING FROM HEAD AND FACE AND HAD A BRUISED SHOULDER. PT WAS NOT SURE WHAT CAUSED HER TO FALL. IV POLE WAS FOUND ON THE FLOOR BROKEN IN HALF AT THE PLATFORM. FORTY-SEVEN POLES WERE FOUND IN THE HOSP THAT WERE CRACKED AT THE PLATFORM. THE METAL PLATFORMS WERE REMOVED FROM ALL POLES AND A METAL SLEEVE WAS INSTALLED TO PREVENT A FUTURE ACCIDENT. PT MAY HAVE BEEN USING IV POLE TO SUPPORT HERSELF WHILE GETTING OUT OF BED. PT WAS INCONTINENT AND MAY HAVE HAD URINE RESIDUE ON FLOOR WHICH LEAD OR CONTRIBUTED TO FALL. PT WAS FOUND TO HAVE HEAD INJURIES AND WAS SENT TO ICU AND LATER TRANSFERRED TO ANOTHER HOSP.
24 GAUGE, 3" CATHETER PLACED. LINE FLUSHED WITH SALINE. AFTER FLUSHING, PATIENT'S FACE BECAME FLUSHED. HE FELT NAUSEATED AND HAD INCREASED DIFFICULTY WITH BREATHING. CATHETER WAS IMMEDIATELY REMOVED AND OXYGEN GIVEN. SYMPTOMS RESOLVED WITHIN 10 MINS. NO MEDICATION TREATMENT GIVEN. PT BACK TO BASELINE WITHIN 30 MINS.
NEW COLONOSCOPE USED FOR A PROCEDURE ON 3/27/96. WHEN CLEANING SCOPE FOR SECOND PROCEDURE "LEAK TESTER" DETECTED A LEAK APPROX 4" FROM THE DISTAL TIP OF THE INSERTION TUBE. RPTR HAD RECEIVED THE SCOPE FROM ANOTHER MEDICAL CENTER ON 3/26/96 VIA COURIER.
RPTR HAD SILICONE BREAST IMPLANTS FROM "19--" TO 1995. SHE HAD MAMMOGRAMS EVERY YEAR. IN 1995, THE TEST SHOWED ONLY THE LEFT IMPLANT LEAKING. SHE WENT TO HER DOCTOR AND REQUESTED TO HAVE BOTH IMPLANTS REMOVED. WHEN THE IMPLANTS WERE REMOVED, IT WAS FOUND THAT THE RIGHT IMPLANT WAS LEAKING AND IT WAS WORSE THAN THE LEFT. THEY HAD A STICKY, GOOEY SUBSTANCE ALL OVER THEM. SHE GOT THEM FROM THE HOSP JUST BEFORE THEY WERE GOING TO BE DISPOSED OF. THEY ARE NOT IN FORMALDEHYDE. SHE HAS HAD MANY STRANGE PROBLEMS SUCH AS CONSTANT PAIN IN HER BACK; IMPAIRED VISION; AND MEMORY, URINARY AND BOWEL PROBLEMS. HAVING BEEN A HEALTHY PERSON ALL HER LIFE, SHE CONTRIBUTES THESE CONDITIONS TO THE SILICONE IMPLANTS.
RPTR HAD BREAST IMPLANTS EXPLANTED IN 1995 FROM OPERATIVE REPORT. "POSTOPERATIVE DIAGNOSIS: 1. HISTORY OF A BILATERAL BREAST AUGMENTATION WITH SILICONE GEL IMPLANTS, GRADE 4 CAPSULAR DEFORMITY OF THE RIGHT, GRADE 3 CAPSULAR DEFORMITY OF THE LEFT, PROBABLE RUPTURED GEL IMPLANT ON THE MAMMOGRAPHY ON THE LEFT, LATERAL AXILLARY ADENOPATHY AND MULTI-SYSTEM SYMPTOMATOLOGY. 2. RUPTURED LEFT GEL IMPLANT INTACT, 300 CC SILICONE GEL IMPLANT ON THE RIGHT." OPERATION PERFORMED: 1. BILATERAL TOTAL CAPSULECTOMIES WITH REMOVAL OF IMPLANT AND IMPLANT MATERIAL. (*)
PT WAS BEING EVALUATED FOR THE INTEGRITY OF THE ELECTRODE ARRAY OF SURGICALLY IMPLANTED COCHLEAR IMPLANT. DURING THE TEST CONDUCTED BY MFR'S REP THE PT EXPERIENCED A SUDDEN PAIN, PRESUMABLY DUE TO ELECTRICAL STIMULATION OF AN ELECTRODE ADJACENT TO ONE OF THE PAIN FIBERS OF A NERVE IN THE MIDDLE EAR. THIS STUNNED THE PT. HE FEELS THAT HE HAS SINCE HAD PROBLEMS EMANATING FROM THIS TEST THAT HAVE RESULTED IN THE INCREASED PERCEPTION OF NOISE (TINNITUS), DIZZINESS AND PRESSURE, NOT ONLY IN THE IMPLANTED EAR BUT HIS OPPOSITE SIDE WHERE A RECORDING ELECTRODE HAD BEEN PLACED. RPTR HAS NO INFO THAT SUPPORTS THAT ANYTHING WAS DONE INAPPROPRIATELY DURING THE TEST AND MANY OF THESE TESTS HAVE BEEN DONE PREVIOUSLY. HOWEVER, RPTR WAS NOT PERFORMING THE TEST, NOR WAS RPTR PRESENT.
CUSTOMER REPORTED THAT ON TWO SEPARATE OCCASIONS WHEN INJECTED WITH SALINE THE BALLOON ON THE CATHETER BURST WHILE IN THE PT. THE PT HAD UNDERGONE A TRANSURETHRAL RESECTION SURGICAL PROCEDURE. THE CATHETER WAS INSERTED IN THE PT TO APPLY PRESSURE TO THE AREA WHERE THE RESECTION HAD OCCURRED TO PREVENT PT BLOOD LOSS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING A ROUTINE GENERATOR CHANGE OUT THIS SUTURELESS MYOCARDIAL LEAD AND ANOTHER WERE REMOVED FROM SERVICE FOR NO OUTPUT. CO WILL ASSUME THE LEADS ARE CAPPED AND REMAIN IMPLANTED. IMPLANT DATE 9/15/92. OUT-OF-SERVICE DATE 2/1/96. TOTAL IN-SERVICE TIME 40 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT A PT WITH AN IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD SYSTEM HAD EXPERIENCED UNDERSENSING. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO REPLACE THE ATRIAL LEAD. ANOTHER LEAD WAS IMPLANTED. CO SUSPECTS THE LEAD WAS CAPPED. IMPLANTED: 8/14/90. EXPLANTED APPROXIMATELY: 2/1/96 (IMPLANTED 65 MONTHS).INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT A PT WITH AN IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPERIENCING AN INAPPROPRIATE PACING RATE RESPONSE. WHEN PROGRAMMED TO THE DDDR MODE (WITH NO ACTIVITY) THE PACING RATE INCREASED. WHEN PROGRAMMED TO DDD AN NORMAL PACING RATE WAS OBSERVED. THE IPG WAS SCHEDULED TO BE REPLACED ON 2/15/96. IMPLANTED: 7/25/94 (IMPLANTED 18 MONTHS).INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TWO RATE SENSING LEADS HAD EXPERIENCED OVERSENSING/INAPPROPRIATE SHOCKS. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN FOUND ONE OF THE RATE SENSING LEADS HAD LEAD ABRASION. IT IS UNKNOWN WHICH LEAD HAD THE ABRASION. THE PHYSICIAN CAPPED BOTH RATE SENSING LEADS AND IMPLANTED A NEW TRANSVENOUS DEFIBRILLATION LEAD. BOTH LEADS IMPLANTED 12/21/92. CAPPED AND REMOVED FROM SERVICE 2/9/96. IMPLANTED 37 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AN INVASIVE PROCEDURE WAS PERFORMED TO REPOSITION THIS LEAD AFTER IT DISLODGED. IMPLANT DATE 2/6/96. REMAINS ACTIVE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DEVICE HAS BEEN EXPLANTED. DEVICE HAS NOT BEEN RETURNED TO MFR FOR EVALUATION. PT IS FEMALE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT IMPLANTED WITH A DEFIBRILLATOR (AICD) WAS EXPERIENCING SENSING PROBLEMS. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE TO EVALUATE THE AICD AND LEAD SYSTEM. THE PHYSICIAN FOUND WEAR MARKS ON THE INSULATION OF BOTH RATE SENSINGS LEADS. THE PHYSICIAN REPAIRED THE LEADS AND BOTH LEADS REMAIN IMPLANTED. IMPLANTED 9/11/92.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AN INCIDENT OCCURRED INVOLVING A WIRE WHILE PERFORMING A CYSTOSCOPIC STONE EXTRACTION. RESISTANCE WAS ENCOUNTERED UPON ADVANCEMENT OF THE WIRE. CONTRAST EXTRAVASATION WAS NOTED EMANATING FROM THE PROXIMAL URETER. A PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED, AND THE STONE EXTRACTION PROCEDURE WAS ABORTED. ATTEMPTS TO ACQUIRE FURTHER DETAILS OF CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE DISCARDED.  THE DEVICE WAS DESTROYED/DISPOSED OF.
PULSE GENERATOR WAS EXPLANTED BECAUSE OF INFECTION AND PACEMAKER EROSION. IMPLANT DATE 3/3/93. EXPLANT DATE 5/26/94. TOTAL IMPLANT TIME 14 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH A DEFIBRILLATOR (AICD) RECEIVED INAPPROPRIATE SHOCKS. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE TO EVALUATE THE SYSTEM AND ELECTED TO REMOVE BOTH SAME MODEL LEADS FROM SVC, AND REPLACED THEM WITH A BIPOLAR ENDOCARDIAL TINED LEAD. THE LEADS WERE CAPPED AND REMAIN IMPLANTED. THE AICD REMAINS IMPLANTED AND FUNCTIONS APPROPRIATELY. IMPLANTED 3/5/93. REMOVED FROM SVC 6/8/94. TOTAL IMPLANT TIME 15 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A YEAR AFTER UNICOMPARTMENTAL KNEE REPLACEMENT PT COMPLAINED OF INCREASING PAIN IN LEFT KNEE. A REVISION SURGERY WAS DONE BECAUSE OF POLYETHYLENE WEAR ON THE TIBIAL COMPONENT AND ADVANCED DEGENERATIVE ARTHRITIC CHANGES IN THE PATELLO-FEMORAL JOINT. A SUCCESSFUL TRICOMPARTMENTAL TOTAL KNEE REPLACEMENT WAS PERFORMED. FEMALE PT IS 63 YRS OLD.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A 64-YR-OLD FEMALE EXPERIENCED TWO DISLOCATIONS SUBSEQUENT TO HER INITIAL IMPLANTATION ONE MONTH AGO. ON REVIEW OF X-RAYS IT WAS FELT THE CUP WAS NOT ADEQUATELY ANTEVERTED. THE PT ELECTED TO UNDERGO REVISION. THE FEMORAL HEAD AND ACETABULAR INSERT WERE REMOVED INCIDENTALLY. A NEW 54 O.D. OUTER SHELL WITH APPROPRIATE INSERT WAS IMPLANTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEAD WAS REMOVED TWO DAYS POST-OP BECAUSE OF LEAD DISLODGEMENT. IMPLANTED 10/3/94. EXPLANTED 10/5/94. TOTAL IMPLANT TIME 2 DAYS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH A DEFIBRILLATOR (AICD) RECEIVED A SHOCK IN SINUS RHYTHM. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE TO EVALUATE THE SYSTEM AND FOUND AN INSULATION BREAK IN ONE OF THE PT'S LEADS, THE PT ALSO HAD ANOTHER SAME MODEL LEAD. DISTRIBUTOR DOES NOT KNOW WHICH LEAD HAD THE INSULATION BREAK. THE PHYSICIAN ELECTED TO REMOVE THE LEADS FROM SVC AND IMPLANT A BIPOLAR ENDOCARDIAL TINED LEAD. THE AICD REMAINS IMPLANTED. IMPLANT DATE 3/11/93. REMOVED FROM SVC 10/12/94. TOTAL IMPLANT TIME 19 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS LEAD AND ANOTHER SAME MODEL LEAD WERE REMOVED FROM SVC AND AN AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) WAS EXPLANTED BECAUSE "BEEPING TONE EVALUATION REVEALED CHAOTIC COUNTING." IMPLANT DATE 11/19/91. REMOVED FROM SVC 9/8/94. TOTAL IMPLANT TIME 33 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING MAGNET RATE TESTING OF THE PT'S IMPLANTABLE PULSE GENERATOR (IPG), THE PHYSICIAN NOTED A SINGLE BEAT OF LOSS OF VENTRICULAR CAPTURE. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE AND REMOVED THIS LEAD FROM SVC BECAUSE OF A FRACTURE. IMPLANT DATE 2/29/94. REMOVED FROM SVC 10/13/94. TOTAL IMPLANT TIME 7 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING AN OPERATIVE PROCEDURE ON A TRAUMATIC GUNSHOT WOUND, THE SURGEON HAD DIFFICULTY GETTING THE PRODUCT TO FUNCTION APPROPRIATELY. AFTER SEVERAL ATTEMPTS, THE SURGEON FOUND THAT THE JAWS OF THE CLAMP BECAME MISALIGNED. CO IS UNAWARE OF WHETHER OR NOT THE EVENTS DESCRIBED CAUSED OR CONTRIBUTED TO THE PT'S DEMISE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  DESIGN, VALVE - RELIEF.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT IMPLANTED WITH DEFIBRILLATOR (AICD) HAD RECEIVED INAPPROPRIATE SHOCKS. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE TO EVALUATE THE AICD AND LEAD SYSTEM. THE PHYSICIAN FOUND THAT ONE OF THE PT'S RATE SENSING LEADS HAD AN INSULATION DEFECT. THE PHYSICIAN REPAIRED THE LEAD USING MEDICAL SILICONE AND A LEAD STABILIZER. NO FURTHER PROBLEMS NOTED. THE PAPERWORK DID NOT STATE WHICH LEAD HAD THE INSULATION DEFECT. IMPLANTED 7/9/92.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING AN IMPLANT PROCEDURE OF AN IMPLANTABLE PULSE GENERATOR (IPG), THE WRENCH TIP BROKE OFF IN THE HEADER OF THE IPG. WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE LEADS IN THE HEADER, THERE WAS NO OUTPUT FROM THE IPG. THE PT HAD NO INTRINSIC HEART RATE, AND CARDIOPULMONARY RESUSCITATION WAS NECESSARY FOR FOURTEEN MINUTES. THE IPG WAS NOT IMPLANTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEAD WAS EXPLANTED BECAUSE IT HAD BECOME DISLODGED, RESULTING IN NO PACING. IMPLANT DATE 9/15/94. EXPLANT DATE 10/5/94. TOTAL IMPLANT TIME 3 WEEKS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT IS EXPERIENCING PAIN. INSERT HAD MINIMAL POLY WEAR ON THE MEDIAL SIDE. MALE PT IS 92 YRS OLD AND WEIGHS 230 LBS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SEVERE POLY WEAR ON PATELLA CAUSED IT TO LOOSEN FROM THE METAL BACK. MALE PT IS 92 YRS OLD AND WEIGHS 230 LBS. PT IS EXPERIENCING PAIN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS LEAD AND ANOTHER SAME MODEL LEAD WAS REMOVED FROM SVC BECAUSE OF OVERSENSING. BOTH LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANTED 3/13/92. REMOVED FROM SVC 11/18/93. TOTAL IMPLANT TIME 20 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WORN METAL BACKED PATELLA.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
POLYWORN ON MEDIAL SIDE ON INSERT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
THE HOSPITAL IS EXPERIENCING A SEVERE PROBLEM WITH I.V. PUMPS MANUFACTURED BY KENDALL-MCGAW COMPANY.  THE NURSING STAFF AND BIOMEDICAL TECHNICIANS HAVE IDENTIFIED SEVERAL PROBLEMS WITH THE PROGRAMMED DRIP RATE IN SEPTEMBER, 1992.  IN DECEMBER, 1992 THE MFG STATED THE MALFUNCTION REQUIRED CHANGING OF A COMPUTER CHIP AND EACH REPAIR WOULD COST $250 - $400.  MORE THAN THIRTY PUMPS WERE RETURNED TOTHE MANUFACTURER.  IN ADDITION, WE REVIEWED OUR STORAGE PROCEDURES IN CENTERAL SERVICE FOR THE PUMPS NOT IN USE AND ARRANGED FOR THE I.V. PUMPS TO BE CONTINUOUSLY PLUGGED TO ELECTRICITY TO ENABLE ONGOING BATTERY CHARGING AS DIRECTED BY THE MFG.  WE WERE NOT INFORMED IF THIS PROBLEM WAS A MANUFACTURING ERROR OR FAULTY DEVICE.DURING 1993, WE HAVE HAD SPORADIC PROBLEMS WITH THE I.V. PUMPS AND IN SEPTEMBER, 1993 SEVERAL PUMPS WERE REPORTED "FAILING."  ON OCTOBCER 7.1993 WE HAD FIVE I.V. PUMPS REMOVED FROM SERVICES FOR FAILURE TO DELIVER FLUIDS AT THE DRIP RATE SET.  THE MFG WAS NOTIFIED AND THEY ADMITTED TO "A TUBING PROBLEM" AND SAID IT WOULD TURN ARROUND AS THEY WERE CORRECTING IT.  THE MFG HAD TROUBLE SEGRATING THE EXACT LOT NUMBERS.  WE WERE TOLD, BY THE MFG REP THAT WE WERE PROBABLY LOADING THE I.V. PUMP CASSETTES BACKWARDS.  THE NURSING DEPT REVIEWED THE CASSETTE LOADING INFO AND GAVE IMMEDIATE EDUCATION TO THE NURSING STAFF, REGARDING CASSETTE PLACEMENT.THE PROBLEMS WITH THE I.V. PUMPS HAVE CONTINUED.  WE FELL THE COMPANY HAD IDENTIFIED A "TUBING PROBLEM" AND DID NOT ALERT THEIR CUSTOMERS.  THE MFG HAS ALSO BEEN SLOW TO RESPOND TO OUR REPORTS OF MALFUNCTIONING I>V> PUMPS.  SOME OF THE AREAS EXPERIENCCING I.V. PUMP FAILURES ARE CRITICAL AREAS WHICH INCLUDE THE EMERGENCY DEPT, INTENSIVE CARE UNITS AND LABOR AND DELIVERY.  WE HAVE INTERNAL REPORTS OF TEN TO FIFTEEN PUMPS MALFUNCTIONING DAILY.  THE I.V. PUMP REQUIRES THE MFG'S IV TUBING AND WE ARE ASSUMING ALL LOTS ARE DEFECTIVE.  MULTIPLE TUBING SET UP MUST BE TRIED UNTIL THE CORRECT FLOW RATE IS ACHEIVED.AT THIS TIME WEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  TUBING.  CONCLUSION:  DEVICE FAILURE DIRECTLY CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, USER EDUCATION PROVIDED, NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
LAMINATION ON MEDIAL BEARRING SURFACE, PATELLA COMPONENT. FAILURE DUE TO SECONDARY FACTORS. DISTAL FEMORAL FRACTURE, 2 YEARS PRIOR TO THE REVISION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PLASTIC WAS WORN ON THE TIBIAL INSERT AND THE PATELLA WAS LOOSE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE IMPLANTS SUBSIDED AND POLY WEAR ON THE TIBIAL AND THE PATELLA COMPONENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR REPLACED DUE TO PLASTIC WEAR.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR REPLACED PLASTIC DUE TO WEAR.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
POLYETHYLENE WEAR.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
COMPLETE DISLOCATION OF METAL BACKED PATELLA, EXCESSIVE WEAR TO TIBIAL POLY. NO INGROWTH TO PATELLA AND POOR WEAR ON TIBIAL POLY. REMOVED THE BASEPLATE AND PATELLA AND REPLACED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PATELLA PLASTIC DISLOCATION AND WEARTHROUGH. PATELLA DISLOCATION AND WEARTHROUGH CAUSED WEAR ON BASEPLATE. BOTH WERE REMOVED AND REPLACED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
INSERT APPEARED WORN ON X-RAY, SO REVISION WAS SCHEDULED. INSERT WAS FRAGMENTED IN 3 PIECES AND WAS REPLACED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT PRESENTED WITH SWELLING AND PAIN IN RIGHT KNEE. X-RAYS SHOWED LITTLE SPACE BETWEEN THE TIBIAL/FEMORAL COMPONENTS SO REVISION OF AT LEAST THE INSERT WAS RECOMMENDED. TIBIAL INSERT WAS WORN AND FRACTURED POSTERIORLY ON THE MEDIAL SIDE AND WORN ON THE LATERAL SIDE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
EXCESSIVE WEAR ON TIBIAL INSERT AND TO THE POLY ON METAL BACKED PATELLA. REPLACED INSERT AND PATELLA.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PATELLA BOTTOM BROKEN AT BASE WHERE SMALL STUD IS LOCATED. "ORIGINAL PATELLAR MALLIGNMENT PLACED EXCESSIVE STRESS ON PATELLA COMPONENT RESULTING IN FAILURE."DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IT WAS REPORTED THAT AFTER POSITIONING THE INTRODUCER CATHETER INTO THE PT'S VESSEL, THE PUSHER WIRE WOULD NOT ADVANCE THE FILTER THROUGH THE CATHETER. THE INTRODUCER CATHETER WAS REMOVED AND REPLACED THROUGH THE INITIAL PUNCTURE SITE WITHOUT ANY PT INJURY. THE SECOND FILTER WAS SUCCESSFULLY PLACED WITHOUT ANY FURTHER COMPLICATIONS REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT HAD FALLEN ON THE KNEE. CO BELIEVES THE DIRECT IMPACT OF THE FALL SHEARED THE PATELLA.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
POLYETHELENE BROKE DOWN IN POSTERIOR QUADRANT, RESULTING IN A REVISION TO A MODULAR IMPLANT. WAS IN THE PT APPROX 10 MONTHS.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PT DEVELOPED PAIN IN 1993 AND SAW THE DOCTOR. THE PATELLA AND INSERT WERE REPLACED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
CO RECEIVED AN OUT-OF-SERVICE REMOVAL REPORT WHICH INDICATED THAT THIS LEAD AND ANOTHER WERE REMOVED FROM SERVICE BECAUSE OF A "LEAD DYSFUNCTION." IMPLANT DATE 8/15/91. REMOVED FROM SERVICE 10/12/94. TOTAL IMPLANT TIME 37 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TWELVE STAFF MEMBERS COMPLAINED OF SKIN CRACKING AND RASHES AFTER USING MEDLINE LATEX GLOVES. OF THE TWELVE STAFF MEMBERS, FOUR MEMBERS REQUIRED MEDICAL TREATMENT. ALL FOUR STAFF MEMBERS RECEIVED MEDICATION. ACCEPTABLE DELAYED CONTACT SENSATION STUDY FOR VENDOR IS ON HAND.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
APROXIMATELY TEN STAFF MEMBERS EXPERIENCED ITCHING, BURNING, RED RASH AND BLISTERING WHILE WEARING LATEX EXAM GLOVES (EXACT INCIDENT DATE UNKNOWN). ONE STAFF MEMBER WENT TO EMERGENCY ROOM AND RECEIVED UNSPECIFIED PRESCRIPTION OINTMENT FOR AFFECTED AREA. NINE STAFF MEMBERS APPLIED OTC BENADRYL OINTMENT TO AFFECTED AREA.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  10.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHILE PERFORMING CIRCUMCISION, REPORTEDLY PHYSICIAN HAD DIFFICULTY UNSCREWING CIRCUMCISION INSTRUMENT. TWO PATIENTS LACERATED AND REQUIRING SUTURING. ACCOUNT ALSO HAD BEEN USING INCORRECT SIZE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  2.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
NURSE SLIPPED ON WET OPERATING ROOM FLOOR WHILE WEARING SHOECOVER. NURSE SUSTAINED A BRUISED HIP WHILE X-RAY RESULTS WERE NEGATIVE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ACCOUNT WAS UNABLE TO SUPPLY LOT NUMBER OR SERIAL NUMBER THEREFORE PRECISE MFR CANNOT BE IDENTIFIED. REPORTEDLY PERSON SLIPPED ON OR FLOOR WHILE WEARING SHOECOVERS. THE REPORT SOURCE CLAIMED THE UNIDENTIFIED PERSON HAS BEEN UNABLE TO WORK SINCE THE INCIDENT WHICH OCCURRED APPROX THREE YEARS AGO. CO WAS NOTIFIED OF THIS INCIDENT ON 1/26/95 AND ACCOUNT WOULD NOT SUPPLY FURTHER INFO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CUSTOMER FELL IN DINING ROOM ON CRUTCHES AFTER SUFFERING BROKEN ANKLE. CUSTOMER CLAIMS A SWOLLEN ANKLE AND A JAMMED THUMB. VISITED DOCTOR ON 1/20/95. X-RAYS WERE NEGATIVE. NO FURTHER MEDICAL TREATMENT REQUIRED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ONE STAFF MEMBER EXPERIENCED SKIN IRRITATIONS AND RASHES WITH OPEN SORES WHILE USING CO'S POWDERFREE GLOVES. STAFF MEMBER WAS TREATED WITH BEMATHASONE .5% CREAM THREE TIMES A DAY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED BECAUSE IT EXHIBITED NO OUTPUT. IMPLANT DATE 6/1/94. EXPLANT DATE 6/20/94. TOTAL IMPLANT TIME 20 DAYS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS IMPLANTABLE PULSE GENERATOR WAS EXPLANTED BECAUSE OF INFECTION AND A POSSIBLE MALFUNCTION. IMPLANT DATE 11/8/93. EXPLANT DATE 4/29/94. TOTAL IMPLANT TIME 5 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IT WAS REPORTED THAT DURING A BHP PROCEDURE, THE FIBER TIP BURNED UP AFTER LASING AT 60 WATTS FOR 60 SECONDS AND DETACHED FROM THE FIBER SHAFT AND REMAINED IN PT'S BLADDER.GRASPING FORCEPS WERE USED THROUGH THE PREVIOUSLY PLACED CYTOSCOPE TO RETREIVE THE DETACHED TIP.  NO FURTHER COMPLICATIONS WERE REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IT WAS REPORTED THAT AFTER THE INTRODUCER CATHETER INTO THE PT'S VESSEL AND ATTACHING THE DELIVERY SYSTEM, THE FILTER LEGS GOT STUCK INSIDE THE INTRODUCER WHEN ATTEMPTING DEPLOYMENT.  THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME MAKE TO COMPLETE THE PROCEDURE.  NO FURTHER COMPLICATIONS WERE REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
INFOMATION WAS RECEIVED THAT A PT'S AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM DID NOT DETECT HIS ARRYTHMIA AND HE WAS RESUSCITATED BY THE EMERGENCY MEDICAL TECHNICIANS.  THE PHYSICIANS PERFORMED AN INVASIVE PROCEDURE TO EVALUATE THE SYSTEM.  VISUAL INSPECTION OF THE LEAD SYSTEM BY THE PHYSICIAN NOTED A DISCOLORATION OF THIS RATE SENSING LEAD.  WHEN THE PHYSICIAN PERFORMED PACING AND SENSING THRESHOLDS, HE NOTED ABNORMAL SENSING ON THE RATE PT ALSO HAD ANOTHER MODEL AND SERIAL NUMBERED LEAD.  DURING THE INVASIVE PROCEDURE, THE PHYSICIAN ELECTED TO UPGRADE THE PT'S AICD BECAUSE HE ALSO REQUIRED BRADICARDIA PACING.IMPLANT DATE 9/15/92.  REMOVED FROM SERVICE 7/28/94.  TOTAL IMPLANT TIME 22MONTHS.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IT WAS REPORTED THAT DURING A BPH PROCEDURE, THE FIBER BURNED OUT AND THE GOLD PORTION OF THE FIBER SEPARATED FROM THE UNIT. ENDOSCOPIC FORCEPS WERE INSERTED THROUGH THE PREVIOUSLY PLACED CYSTOSCOPE AND THE BROKEN PIECE WAS RETRIEVED AS DESCRIBED IN THE PRODUCT LABELING. THERE WAS NO FURTHER COMPLICATIONS REPORTED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
RPTR AT HOSP DECLINDED TO COMMENT ON EXACT EVENT. THE RPTR STATED THAT THE HOSP BIOMED DEPT HAS EVALUATED ALL UNITS INVOLVED AND ALL "TESTED OK." RPTR STATED THAT THEIR RISK MGMT INFORMED HIM NO REPORTS WOULD BE FILED AND NO FURTHER FOLLOW-UP AT THIS TIME. WHEN INQUIRING IN REGARDS TO THE CONDITION OF THE INFANT INVOLVED THE RPTR STATED THAT A SMALL REDDENED AREA ALONG THE NARES HAS BEEN CLASSIFIED AS A BURN. THE INFANT IS A 1KG, 28-29 WEEK GESTATION NEONATE WHO IS INTUBATED AND ON THE VENTILATOR AT THIS TIME.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
USER FACILITY STATES THAT SURGEON INSERTED INSTRUMENT INTO PT'S ABDOMEN, AND IT WAS NOT ABLE TO OPEN AND CLOSE THE CLIP PROPERLY. INSTRUMENT DID FUNCTION PROPERLY INTERMITTENTLY AND SURGEON WAS ABLE TO USE IT TO COMPLETE THE PROCEDURE. THERE WERE NO PT INJURIES. CO WAS ADVISED THAT USER FACILITY PREVIOUSLY REPAIRED THE INSTRUMENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IT WAS REPORTED THAT AFTER POSITIONING THE INTRODUCER CATHETER INTO THE PT'S VESSEL AND ATTACHING THE DELIVERY SYSTEM, IT WAS NOTICED THAT THE INTRODUCER HUB WAS CRACKED. THE INTRODUCER CATHETER WAS REMOVED AND REPLACED FOR FILTER DEPLOYMENT. THIS IS THE FIRST OF THREE REPORTED INCIDENTS THAT OCCURRED ON THE SAME PT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IT WAS REPORTED THAT 50 SECONDS AT 60 WATTS INTO A VLAP CASE, THE TIP OF THE FIBER BROKE OFF AFTER BURNING OUT. THE TIP WAS FLUSHED OUT WITH ADDITIONAL IRRIGATION AND WAS SUCTIONED OUT OF THE PT. THE FIBER WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME MAKE TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS BEING REPORTED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AFTER THE FILTER WAS PLACED WITHIN THE TARGETED LOCATION AND WHEN REMOVING THE DELIVERY SYSTEM FROM THE INTRODUCER CATHETER, THE HUB OF THE INTRODUCER WAS NOTED TO BE CRACKED. THE PROCEDURE HAD BEEN COMPLETED HOWEVER, THE POST PROCEDURE VENACAVOGRAM HAD NOT BEEN PERFORMED. A REPLACEMENT INTRODUCER CATHETER WAS PLACED IN ORDER TO COMPLETE THE VENACAVOGRAM. NO FURTHER COMPLICTIONS WERE REPORTED. THIS WAS THE THIRD OF THREE INCIDENTS THAT OCCURRED ON THE SAME PT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SEVERAL STAFF MEMBERS EXPERIENCED BURNING SENSATION, CRACKING, SWELLING AND REDNESS AFTER USING CO'S LATEX EXAM GLOVES. NO MEDICAL TREATMENT NECESSARY. UNABLE TO IDENTIFY MFR DUE TO SEVERAL DIFFERENT LOT NUMBERS OF GLOVES BEING USED AT THE SAME TIME.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A MAJORITY OF STAFF MEMBERS EXPERIENCED BURNING ITCHING SENSATION, REDNESS, SWELLING, CRACKING AND DRYNESS WHILE USING CO'S LATEX EXAM GLOVES. SEVERAL STAFF MEMBERS WENT TO THE DERMATOLOGIST FOR CORTIZONE CREAM. UNABLE TO IDENTIFY MFR DUE TO TWO DIFFERENT LOT NUMBERS BEING USED AT THE SAME TIME.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AFTER THE FILTER WAS PLACED WITHIN THE TARGETED LOCATION AND AFTER REMOVING THE DELIVERY SYSTEM FROM THE INTRODUCER CATHETER, THE HUB OF THE INTRODUCER BROKE WHEN ATTACHING THE SYRINGE TO PERFORM THE VENACAVOGRAM. THE INTRODUCER CATHETER WAS REMOVED AND REPLACED TO COMPLETE THE FOLLOW-UP VENACAVOGRAM. NO FURTHER COMPLICATIONS WERE REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AFTER POSITIONING THE INTRODUCER CATHETER INTO THE PT'S VESSEL AND ATTACHING THE DELIVERY SYSTEM, IT WAS NOTICED THAT THE FILTER HOUSING WAS BENT. DEPLOYMENT WAS ATTEMPTED AND THE WIRE WOULDN'T ADVANCE THE FILTER THROUGH THE INTRODUCER. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THE FILTER WAS PLACED AT THE TARGETED LOCATION WITH NO FURTHER COMPLICATIONS BEING REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AFTER POSITIONING THE INTRODUCER CATHETER INTO THE PT'S VESSEL AND ATTACHING THE DELIVERY SYSTEM, THE FILTER HOUSING CRACKED DURING THE PROCEDURE. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT TO COMPLETE THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED BECAUSE IT WAS DAMAGED BY EXTERNAL DEFIBRILLATION. IMPLANT DATE 10/19/92. EXPLANT DATE 6/18/94. TOTAL IMPLANT TIME 19 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT'S KNEE WAS UNSTABLE AND SHOWED SEVERE SIGNS OF LOOSENING.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
KNEE WAS REVISED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT'S KNEE BECAME PAINFUL AND SWOLLEN. BONE SCAN SHOWED LOOSENING AT BONE/IMPLANT INTERFACE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT WAS IN A CAR ACCIDENT WHICH CAUSED THE ACETABULAR COMPONENT TO LOOSEN. A NEW CUP WAS IMPLANTED BY DR.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
CO RECEIVED INFO THAT THIS LEAD WAS REMOVED FROM SERVICE BECAUSE OF INSULATION PROBLEMS. THE PT HAD TWO SAME MODEL LEADS. IT IS NOT KNOWN WHICH LEAD HAD THE PROBLEM. IMPLANTED 6/10/93.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PHYSICIAN INFORMED CO THAT THIS PT, WHO HAS AN IMPLANTABLE PULSE GENERATOR (IPG), COMPLAINED OF PECTORAL MUSCLE STIMULATION. THE IPG WAS REPROGRAMMED TO RESOLVE THE MUSCLE STIMULATION. TWO WEEKS LATER THE PT WAS NOTED TO HAVE "OVERSENSING" AND COMPLAINTS OF DIZZINESS. REPROGRAMMING WAS AGAIN PERFORMED. DURING THE SECOND REPROGRAMMING THE IPG EXHIBITED INTERMITTENT EPISODES OF LOSS OF CAPTURE. THE PT WAS SCHEDULED FOR A CONSULT WITH A SECOND PHYSICIAN; HOWEVER, THE PT EXPIRED BEFORE HER APPOINTMENT. IMPLANTED 3/24/94. EXPLANTED 5/22/94. TOTAL IMPLANT TIME 2 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED AN OUT-OF-SERVICE REMOVAL REPORT WHICH INDICATED THAT THIS LEAD AND ANOTHER MODEL WERE REMOVED FROM SERVICE BECAUSE OF "MULTIPLE COUNTING." THIS WAS NOTED WHEN "PUSHING ON THE DEFIBRILLATOR." THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANT DATE 3/23/92. REMOVED FROM SERVICE 10/11/94. TOTAL IMPLANT TIME 30 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IT WAS REPORTED THAT THE PRODUCT CAUSED A SUPERFICIAL BURN ON THE CORNER OF A PT'S MOUTH. THE RPTR STATED THAT NO ADD'L INFO IS AVAILABLE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
NO EVENT DESCRIPTION SUBMITTED WITH REPORT.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  CRITICAL CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-JUL-94.  SERVICE PROVIDED BY:  USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT SCHEDULED FOR SURGERY FOR REMOVAL OF IUD.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  OTHER, OTHER, NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
A YR AFTER UNICOMPARTMENTAL KNEE REPLACEMENT PT COMPLAINED OF INCREASING PAIN IN LEFT KNEE.  AT REVISION SURGERY BECAUSE OF POLYETHYLENE WEAR ON THE TIBIAL COMPONENT AND ADVANCED DEGENERATIVE ARTHRITIC CHANGES IN THE PATELLO-FEMORAL JOINT A SUCCESSFUL TRICOMPARTMENTAL TOTAL KNEE REPLACEMENT WAS PERFORMED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IT WAS REPORTED THAT AFTER POSITIONING TH EINTRODUCER CATHETER INTO THE PT'S VESSEL AND ATTACHING THE DELIVERY SYSTEM, THE FILTER LEGS GOT STUCK INSIDE THE INTRODUCER SHEATH AT THE HUB AREA WHEN ATTEMPTING DEPLOYMENT.  THE SHEATH WAS CUT BELOW THE FILTER TO ENABLE PLACEMENT OF A GUIDEWIRE TO MAINTAIN THE ENTRY SITE AND THEN THE SHEATH WAS REMOVED.  THE ENTIRE SYSTEM WAS REPLACED WITH ANOTHER OF THE SAME MAKE TO COMPLETE THE PROCEDURE.  NO FURTHER COMPLICATIONS WERE REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
6/3/94 - RNTHEY SAID THEY WERE USING THE MONCRIEF-POPOVICH CATHETER AND IMPLANTATION TECHNIQUE.  WHEN THEY EXTERIORIZED THE CATHETER IT STARTED LEAKING.  EXAMPLE: ONE PT WAS DIABETIC AND THE NURSE STARTED THE PT AT 1500 CC EXCHANGES AND WHEN THEY WENT TO 2000 CC EXCHANGES THE CATHETER STARTED TO LEAK.  THEY HAD SEVEN TOTAL PTS WHERE THEY USED THE MONCRIEF-POPOVICH IMPLANTATION TECHNIQUE AND FOUR OF THE SEVEN PTS LEAKED.6/14/94 - SURGEONDR. INFORMED US THAT HE PUT ONE CATHETER IN USING OUR IMPLEMENTATION AND IT WAS DOING FINE.  THE SECOND CATHETER THEY PUT IN LEAKED A BIT.  DR. ALSO INFORMED US THEY WERE CURLING UP THE CATHETER AND STUFFIN THE END INTO A POCKET MADE IN THE SUBCUTANEOUS TISSUE.  THE MONCRIEF-POPOVICH IMPLANTATION TECHNIQUE SAYS TO MAKE A STRAIHT SUBCUTANEOUS TUNNEL AND BURY THE PORTION OF THE CATHETER TO BE EXTERIORIZATION IN THIS TUNNEL.  THE DANER OF INFECTION BY CURLIN THE END OF THE CATHETER AND STUFFIN IT IN A POCKET WAS DISCUSSED.  DR. AREED IT MIHT BE BETTER TO BURY THE CATHETER STRAIGHT AND REQUESTED ANOTHER IMPLANTATION VIDEO TO VIEW.  WE SENT OUR RECENT RESEARCH INFORMATION AND UPDATED INSTUCTION ROCHURE.6/16/94CALLED THE RN TO FIND OUT WHICH HOSPITAL THEY IMPLANTED THE MONCRIEF-POPOVICH CATHETER USING THE IMPLANTATION TECHNIQUE AT.  WE DISCOVER THAT THE HOSPITAL THE IMPLANTED ATHEIR CATHETERS AT WAS NOT ORDERING THE MONCRIEF-POPOVICH CATHETER.  RN WAS INFORMED THAT THE MONCRIEF-POPOVICH CATHETER COULDN'T HAVE EEN USED ECAUSE THE HOSPITAL DOES NOT HAVE THEM IN STOCK.  RN INFORMED US THAT THEY WERE USING THE SWANNECK CATHETER WITH THE MONCRIEF-POPOVICH IMPLANTATION TECHNIQUE WITH OTHER CATHETERS OTHER THAN THE MONCRIEF-POPOVICH CATHETER.  WE INFORMED RN AND SHE SAID SHE WOULD INFORM THE DOCTORS AND SURGEONS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  7.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE NOT USED AS LABELED/INDENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  NO.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT WAS BORN ON 2/9/96 AND FOUND TO HAVE HYPOPLASTIC LEFT HEART SYNDROME.  SHE WAS TRANSFERRED TO THIS HOSPITAL ON 2/10/96 FOR SURGICAL REPAIR OF THIS CONDITION.THIS PT WAS TAKEN TO SURGERY ON 2/14/96 FOR A MODIFIED STAGE I NORWOOD PROCEDURE UNDER CARDIOPULMONARY BYPASS AND HYPOTHERMIA.  THE 9MM PULMONIC VALVE USED IN THIS PROCEDURE WAS OBTAINED FROM A TISSUE CENTER.  AT THE TIME OF SURGERY, THIS GRAFT WAS THAWED ACCORDING TO THE PROVIDER'S INSTRUCTIONS AND FOUND TO BE DISINTEGRATING AND DISSECTING.  AS THE PT WAS ALREADY ON BYPASS, THERE WAS NO TIME TO OBTAIN ANOTHER GRAFT SO THE SURGEONS USED AS MUCH OF THE GRAFT AS THEY FEASIBLE COULD.  THE PROCEDURE WAS COMPLETED BUT WHEN THE CHILD WAS WEANED FROM BYPASS SHE BECAME HEMODYNAMICALLY UNSTABLE AND BRADYCARDIC.  CPR WAS INITIATED BUT THE PT EXPIRED AT 6:10 P.M. ON 2/14/96.THE TISSUE CENTER HAS BEEN NOTIFIED OF THE CONDITION OF THE GRAFT AND THE DEATH OF THE PT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  OTHER.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
RPTR STATED THAT HE BENT TO GET SOMETHING OUT OF THE REFRIGERATOR. HE FELT SOMETHING IN HIS BACK AND HE COULD NOT STRAIGHTEN UP. HE EXPERIENCED SEVERE PAIN THAT LASTED BETWEEN 3 TO 6 WEEKS. HE COULDN'T WALK, TAKE STEPS. HE ALSO EXPERIENCED PAIN GOING TO THE BATHROOM, AND HIS CHILDREN HAD TO PUT ON HIS SHOES. IT TOOK HIM 20 MIN TO GET IN AND OUT OF BED. DR TOOK AN X-RAY AND TOLD HIM THAT ONE OF THE SCREWS WAS BROKEN. THE PAIN CONTINUED AND GOT WORSE. ON 3/12/96 DR REMOVED THE SCREWS. RPTR STATES THAT HE DOESN'T KNOW IF HE HAS ANY PERMANENT DAMAGE, BECAUSE HE IS STILL HEALING FROM THE SURGERY.
AFTER PORT WAS IMPLANTED 6/14/95, RPTR HAD 8 CHEMOTHERAPY INJECTIONS. EACH TIME IT EITHER BURNED OR WAS PAINFUL. SHE WAS SUPPOSED TO HAVE CHEMOTHERAPY FOR ONE YEAR BECAUSE OF COLON CANCER. ON 10/4/95 THE NURSE INJECTED HEPARIN AND PORT "EXPANDED" AND HEPARIN BEGAN DRAINING INTO THE BODY. SHE WAS TOLD TO HAVE THE PORT REMOVED ASAP. ON 10/6/95 THE PORT WAS SURGICALLY REMOVED. ALL TREATMENT WAS STOPPED. THE DEVICE WAS THROWN OUT. IT WAS MALFUNCTIONING.
PT EXPERIENCED NECK AND ARM PAIN ABOVE CATHETER SITE. PT CAME TO HOSP FOR DYE STUDY. UNABLE TO FLUSH. PT COMPLAINED OF PAIN AND NECK NOW SWOLLEN. DYE STUDY SHOWED A PIECE OF CATHETER FREE-FLOATING IN RIGHT ATRIUM. PT UNDERWENT PROCEDURE VIA GROIN AREA TO RETRIEVE THE PIECE. PT DISCHARGED. NO PROBLEMS.
LEFT FEMORAL ROD BROKE. NEW ROD REINSERTED.
RPTR FOUND THIS FORM IN HIS PUBLIC CITIZEN HEALTH LETTER. THIS OCULAR PROSTHESIS WAS TO HAVE BEEN FOR REPLACEMENT FOR LENGTHY USE. LESS THAN 3 WEEKS OF IMPLANTATION USE. HE SUFFERED SEVERE CHEMICAL BURNS TO HIS EYE SOCKET CAUSED BY THE NEWLY MADE ARTIFICIAL EYE, THAT PERSISTS TO THIS DAY. HE FEELS PRICE GOUGING IN THIS TRADE IS VERY COMMON, AND QUALITY CONTROL AND GOVERNMENT REGULATION NONEXISTENT.
ON 12/8/95 MFR'S INFUSION PUMP WAS IMPLANTED IN RPTR'S BODY. BEFORE THE PROCEDURE STARTED HER DR AND MFR'S REP HAD A LONG DISCUSSION ABOUT HER BODY SIZE AND HOW THIN SHE WAS. SHE IS A SIZE 3, 105 LBS. WHEN SHE AWOKE FROM SURGERY SHE REALIZED THE PUMP HAD BEEN IMPLANTED MID-BODY BELOW HER NAVEL. HER HUSBAND AND SHE WERE UNDER THE IMPRESSION THAT THE PUMP WOULD BE TO THE RIGHT OR LEFT SIDE OF HER BODY. UPON QUESTIONING THE DR ABOUT THIS, HE EXPLAINED THE REP HAD SUGGESTED THAT THIS WAS THE ONLY SITE THE PUMP WOULD COMFORTABLY FIT HER BODY. FROM 12/8/95 UNTIL 2/18/96, THE PAIN CAUSED FROM THE PUMP AND THE CATHETER IN HER SPINE CAUSED WHAT COULD ONLY BE DESCRIBED AS AGONY. THE PUMP SITE AND THE CATHETER SITE WERE PAINFUL TO THE TOUCH OF ANYTHING, INCLUDING CLOTHING. THE PUMP WAS SO NOTICEABLE THAT LOOSE-FITTING CLOTHES COULD NOT HIDE IT, BUT A MFR'S BROCHURE STATED OTHERWISE. ABOUT 2 WEEKS AFTER THE IMPLANT, THE PUMP STARTED BEEPING. HER DR COULD NOT BE REACHED IMMEDIATELY SO HER HUSBAND CALLED MFR'S 800 NUMBER. THE CUSTOMER REP EXPLAINED THAT IT WAS A LOW RESERVOIR WARNING SIGNAL. HER HUSBAND THEN ASKED ABOUT THE PAIN FROM THE PUMP AND HOW FAR OUT THE PUMP PROTRUDED FROM HER ABDOMEN. THE REP TOLD HIM THE PAIN WOULD PROBABLY GO AWAY IN A FEW MORE WEEKS. WHEN SHE FOUND OUT RPTR WAS A SIZE 3, SHE TOLD RPTR'S HUSBAND THAT THEY HAD SOME PROBLEMS WITH THE PUMP IN SMALL PEOPLE, THAT A SMALLER PUMP WAS IN DEVELOPMENT TO CORRECT THIS PROBLEM AND THAT THE SMALL PUMP WOULD PROBABLY BE APPROVED IN ABOUT 6 MOS. RPTR BELIEVES THE MFR PURPOSELY HID THIS PUMP SIZE PROBLEM FROM HER AND SHOULD HAVE INFORMED HER AND HER HUSBAND OF THIS.
RPTR DEVELOPED A BURNING PAIN IN HER ARMS AND CHEST. SHE ALSO EXPERIENCED LOW GRADE FEVER, RASHES ON HER LEGS, BLISTERS ON HER GUMS, CHILLS, AND A "STRANGE FEELING." SHE IS NERVOUS AND HER STOMACH IS NUMB FROM THE SURGERY.
PT EXPERIENCING PAIN AND SWELLING AT SITE OF PREVIOUS INTERNAL FIXATION OF FX LEFT HIP. ON 3/21/96, PT UNDERWENT PROCEDURE TO REPLACE PLATE THAT HAD HELD HIP IN PLACE. THE 3 SCREWS HOLDING THE ORIGINAL PLATE BROKE. SCREWS AND PLATE WERE REMOVED AND THE HIP RE-FIXATED. PT TOLERATED PROCEDURE WELL.
DEFECTIVE FILTERED VENOUS RESERVOIR WAS LEAKING AT THE VENOUS INLET.
PT HAD RIGHT AND LEFT TOTAL HIP REPLACEMENTS USING MFR'S ACETABULAR POLY INSERTS. DUE TO THE COMPLETE WEAR AND BREAKING OF THE POLYETHELENE COMPONENTS BILATERALLY SHE NEEDED TO UNDERGO TOTAL HIP REVISIONS. RIGHT REVISION WAS ON 10/18/95 AND THE LEFT REVISION ON 10/30/95. RPTR SUSPECTS THERE WAS A PROBLEM WITH THE QUALITY OF THE PRODUCT THAT OCCURRED DURING MFG AND STERILIZATION.
POST MASTECTOMY PT HAD BILATERAL BREAST IMPLANT RUPTURE, NECESSITATING REMOVAL AND REPLACEMENT OF IMPLANTS.
PT UNDERGOING TOTAL HIP REPLACEMENT, FEMORAL REAMING TO ACCEPT PROSTHESIS, SUCTIONING DOWN FEMUR WITH FEMORAL TIP. SCRUB NURSE OBSERVED SUCTION TIP MISSING FOLLOWING SUCTION. SEARCH ENSUED OF FIELD, TRASH ETC - NEGATIVE. SURGEON REMOVED BONE PLUG TO EXAMINE SHAFT TO VALIDATE TIP NOT LODGED IN CHANNEL - NEGATIVE. EXTENDED SURGICAL PROCEDURE BY 45 MIN. X-RAY PROCEDURES PERFORMED TO VISUALIZE - NEGATIVE. MFR NOTIFIED. SUBSTITUTE PRODUCT ORDERED FOR SIMILAR PROCEDURES.
FOOT PEDALS GAVE WAY WHILE PT WAS STANDING ON THEM. PT CRASHED TO FLOOR WHILE IN VERTICAL POSITION CAUSING INCREASED FORCES THROUGH BILATERAL LOWER EXTREMITIES AND LUMBAR SPINE. PT STATED IMMEDIATE ONSET OF LOW BACK PAIN. CLINICAL ENGINEERING HAS IDENTIFIED BELT FAILURE CONTRIBUTING TO THE LOSS OF HYDRAULIC PRESSURE TO THE PEDALS.
AT THE BEGINNING OF A CARDIOVASCULAR PROCEDURE AND AFTER THE INDUCTION OF ANESTHESIA, A PT MONITOR BLANKED AND LOST CONTACT WITH THE PT. THE ANESTHESIOLOGIST HAD TO MONITOR THE PT MANUALLY VIA THE CAROTID PULSE. PROCEDURE COMPLETED.
THE BUCKY ARM FELL OFF AND STRUCK PT ON THE FOREHEAD. THE MACHINE WAS BEING POSITIONED TO X-RAY SINUS SERIES WHEN THE PIECE FELL.
PT PRESENTED TO THE EMERGENCY DEPT WITH ONE DAY HISTORY OF VERTIGO AND VOMITING. CT SCAN REVEALED MARKED DILATION OF LATERAL AND THIRD VENTRICLES. PT HAD SHUNT PLACED 1/3/96.
WHILE PERFORMING CATARACT SURGERY THERE WAS COLLAPSE OF THE ANTERIOR CHAMBER OF THE EYE. A LENS WAS, HOWEVER, INSERTED SUCCESSFULLY AND IT WAS FELT THERE WOULD BE GOOD RESULTS. ACCORDING TO THE SURGEON, THE VACUUM DID NOT SHUT OFF AS IT SHOULD HAVE AND RESULTED IN THE INJURY. THE MFR'S REP WAS PRESENT BUT COULD NOT REPRODUCE  THE INCIDENT. THE MDR STATED IT WAS AN INTERMITTENT PROBLEM WITH THIS ONE PARTICULAR MACHINE. MACHINE PART RETAINED BY RISK MGMT.
REMOVAL OF DEFLATED RIGHT BREAST PROSTHESIS.
DURING PERCUTANEOUS NEPHROSTOMY PROCEDURE, DILATOR BROKE UNDER SKIN SURFACE. DURING ATTEMPT TO REMOVE DILATOR VIA SKIN INCISION, DILATOR BROKE INTO ADDITIONAL FRAGMENTS. NOT ALL FRAGMENTS WERE RETRIEVED.
BALLOON PUMP LOST POWER AND DID NOT ALARM. PROBLEM IDENTIFIED AS A BAD FUSE. BATTERY WIRE NOT BEING REGENERATED WHICH CAUSED LOSS OF POWER. NO INJURY TO PT.
PT TO OR FOR THORACOSCOPY PROCEDURE. WHEN MD ATTEMPTED TO USE THE THORACIC LINEAR CUTTER IT WOULD NOT OPERATE. AN OPEN THORACOTOMY WAS DONE.
PT WAS DOING WELL STATUS POST AORTIC VALVE REPLACEMENT AND MITRAL VALVE REPLACEMENT. PT SUDDENLY DEVELOPED ELECTROMECHANICAL DISSOCIATION REQUIRING EXTENDED CPR INCLUDING OPENING THE CHEST. PT WAS RETURNED TO OR AFTER STABILIZATION. PT DEVELOPED AYSTOLE ON MAXIMUM INOTROPIC SUPPORT/IABP WITH TEMPORARY PACING WIRES. PT EXPIRED AFTER UNSUCCESSFUL CODE BLUE ON 3/23/96. SUSPECT VALVE FAILURE, PROBABLE MITRAL.
PHYSICIAN PERFORMED ROTATIONAL ATHERECTOMY OF THE RIGHT CORONARY ARTERY WITH SUBSEQUENT BALLOON ANGIOPLASTY OF A PREVIOUSLY STABLE PT. PT BECAME HEMODYNAMICALLY UNSTABLE WITH DECREASED B/P AND DECREASED HEART RATE. DOPAMINE, FLUIDS AND ATROPINE UTILIZED WITH BACKUP PACING WITH SOME IMPROVEMENT. EKG WAS NOTED TO BE ABNORMAL WITH INCREASED ST'S. INTRODUCED A BALLOON INTO THE CORONARY ARTERY. PT WENT INTO VENTRICULAR FIBRILLATION. PT INTUBATED AND WENT TO OR.
AFTER THE TROCAR WAS INSERTED, THE SAFETY SHIELD DID NOT RETURN TO THE "ON" POSITION. SUBSEQUENT LAPAROSCOPY SHOWED BLEEDING, WHICH THEN NECESSITATED A LAPAROTOMY TO BE PERFORMED. A PERFORATED MESENTERIC ARTERY AND SMALL INTESTINE WERE IDENTIFIED. ON INITIAL EXAMINATION, IMPAIRED ADVANCEMENT OF THE SAFETY SHIELD WAS OBSERVED BY THE SURGICAL STAFF. THIS OBSERVATION WAS NOT REPRODUCIBLE IN A FOLLOW-UP EVALUATION BY BIOMEDICAL ENGINEERING.
WARMER PLACED ON LOWER BODY, PER PHYSICIAN ORDER DURING THORACO-ABDOMINAL AORTIC ANEURYSM REPAIR. AT THE END OF THE CASE, KNEES NOTED TO BE BLISTERED, RIGHT BIG TOE REDDENED. CONTRAINDICATIONS ARE IN INSTRUCTIONS INCLUDED IN BOX MACHINE SHIPPED IN. NOT FOUND UNTIL AFTER INCIDENT. NOT IN OPERATOR'S MANUAL.
WHEN PT WAS UNDERGOING PTCA, DISTAL TIP OF GUIDE WIRE SEPARATED FROM BODY OF WIRE AND MIGRATED TO DISTAL PORTION OF A CORONARY ARTERY. PT HAD CABG; UNABLE TO RETRIEVE TIP.
REMOVAL OF LEFT BREAST IMPLANT DUE TO PT'S COMPLAINT OF ILLNESS. BREAST IMPLANT REMOVED. ON REMOVAL, SURGEONS DISCOVERED IMPLANT HAD RUPTURED EARLIER.
BLADE BROKE INTO TWO PIECES DURING SURGERY. ALL PIECES (2) WERE RETRIEVED. NO INJURY TO PT. UNABLE TO RETURN DEVICE TO MFR, AS RETRIEVED PIECES OF BLADE WERE DISCARDED.
RESIDENT HAD ORDER FOR HEATING PAD TO RIGHT HIP 3 TIMES A DAY FOR 15 MIN. ON 3/16/96 IT WAS NOTED THAT HE HAD 3 DEGREE BURNS TO AREA. HEATING PAD CONTROL WAS IN LOW POSITION AND HAD NOT BEEN LEFT IN EXCESS OF 20 MIN. NOTE: RESIDENT WAS LAYING ON TOP OF PACK. THE PAD WAS BETWEEN RESIDENT AND MATTRESS.
FOLLOWING CABG SURGERY APPROX 24 HRS LATER, BURN NOTED ON PT'S RIGHT HIP. POSSIBLY RELATED TO USE OF CAUTERY EQUIPMENT DURING SURGERY.
UPON PLACING THE POSTERIOR CHAMBER SILICONE LENS INTO THE CAPSULAR BAG, APPROX 1/3 OF THE LENS REMAINED BEHIND IN THE INJECTOR AND 2/3 OF THE LENS WAS DELIVERED INTO THE POSTERIOR CAPSULAR BAG. THE POSTERIOR FRAGMENT WAS LIFTED OUT WITH VISCOELASTIC SURGICAL AID. DUE TO THE MITIGATING CIRCUMSTANCES AND THE ADD'L INTRAOCULAR MANIPULATION THE PHYSICIAN DETERMINED IT WAS NOT PRUDENT TO PROCEED WITH THE ASTIGMATIC KERATOMY.
ALL SYRINGES ARE MEASURED IN CC INSTEAD OF ML. ALL DRUGS ARE MEASURED IN MLS, NOT CC'S. THIS IS INCONSISTENT.
WHILE ATTEMPTING TO PERFORM SKIN GRAFT, A POSSIBLE DERMATOME MALFUNCTION OCCURRED, CREATING 2 LACERATIONS.
WHILE WORKING ON RAMUS, 3 BICORTICAL SCREWS WERE PLACED. AFTER THE THIRD SCREW HOLE WAS MADE, IT WAS NOTICED THAT THE TIP OF THE DRILL BIT APPEARED TO HAVE BEEN SEVERED. PHYSICIAN DETERMINED IT WAS IN THE BEST INTEREST OF THE PT IN ORDER TO AVOID UNNECESSARY HARD AND SOFT TISSUE TRAUMA TO LEAVE THE DRILL BIT IN THE MANDIBLE.
DEVICE WOULD NOT CHARGE PAST 30 JOULES AND THE SCREEN WENT BLANK AND ALL POWER WAS LOST. WHEN BATTERY WAS CHARGED THE SCREEN WOULD LIGHT UP HALF WAY AND WHEN THE MONITOR CHARGED THE SCREEN WOULD GO BLANK AND ALL POWER WOULD BE LOST. BATTERIES WERE CHARGED FROM THE CHARGER AND AFTER 3 ATTEMPTS THE UNIT WORKED.
MONITOR WOULD ONLY MONITOR PT IN LEAD III. THERE WAS NOTHING BUT ARTIFACT IN LEADS I, II AND MCL1. CHANGED BATTERIES AND MONITOR PATCHES. NO CHANGES. ALSO, UNIT PRINTS A RANDOM CODE SUMMARY WITHOUT MONITOR ASKING IT TO.
SILICONE IMPLANTS PLACED IN 1981. RPTR COMPLAINS OF IMPLANTS HARDENING AND FLATTENING IN ONE YEAR, SHOULDER PAIN, SORENESS, NUMBNESS IN LEFT ARM AND FINGERS, SEVERE HEADACHES, EYE THROBBING, NECK AND FINGER STIFFNESS, SHOULDERS FEELING AS IF LOCKING. SHE DEMANDED THAT IMPLANTS BE REMOVED IN 1992. BOTH WERE RUPTURED. SALINE IMPLANTS INSERTED IN 1992, SAME PROBLEMS AS LISTED ABOVE CONTINUED. SALINE IMPLANTS REMOVED 1994. NO DRUGS HELP. SHE LIVES IN PAIN AND MISERY.
THREE DAYS AFTER A GUIDE WIRE SHEARED OFF DURING INSERTION, ANOTHER GUIDE WIRE WAS SHEARING OFF. THE WIRE WAS IMMEDIATELY REMOVED FROM THE PT WITHOUT INJURY TO THE PT. RECALL FILE NO 9634 AND 9636. (ALSO SEE 1008835)
GUIDE WIRE TIP SHEARED OFF DURING INSERTION IN THE CARDIAC CATHETER LAB AND LOST IN THE PT'S INTERNAL ILIAC ARTERY. COULD NOT BE RETRIEVED. RECALL FILE NUMBERS 9634, 9636. (ALSO SEE 1008835)
BILE BAG DEFECTIVE. FLUTTER VALVE LOCATED IN WRONG END OF BAG. UNABLE TO EMPTY BAG.
THE CAPACITOR ON THE HI-LO MOTOR EXPLODED WHILE ATTEMPTING TO RAISE THE BED. WHILE NO ADVERSE EVENT RESULTED FROM THIS PROBLEM, RPTR HAS CONCERN THAT HAD THIS HAPPENED IN AN OXYGEN ENRICHED ENVIRONMENT, A FIRE COULD HAVE BEEN CAUSED, ENDANGERING THE PT AS WELL AS OTHERS. FACILITY CONTACTED CO BY TELEPHONE AND WERE TOLD THAT THE ORIGINAL CAPACITOR WAS A WET TYPE CAPACITOR THAT HAS BEEN REPLACED BY A DRY TYPE CAPACITOR TO ELIMINATE THIS TYPE OF FAILURE. OBVIOUSLY, CO HAS KNOWN OF THE PROBLEM BUT HAS NOT INFORMED USERS OF THE POTENTIAL PROBLEM. CO QUESTIONS THE RELIABILITY OF ALL CAPACITORS ON CO BEDS AND BELIEVES CO SHOULD SUPPLY REPLACEMENTS FOR ALL WET TYPE CAPACITORS AND PROVIDE LABOR TO REPLACE THE CAPACITORS.
CATHETER LUMEN MISSING FROM  HUB WHEN REMOVED FOR INSPECTION. NURSE NOTICED LEAKING AROUND SITE FOLLOWING HEP LOCK. APPLIED TOURNIQUET. NOTIFIED MD.
PT PRESENTED WITH RUPTURED SILICONE IMPLANT IN LEFT BREAST, REQUIRING SURGICAL REMOVAL. IMPLANTED APPROX 8 YEARS.
CATHETER LAB CALLED AND CLAIMED THAT THE DEFIBRILLATOR DID NOT DISCHARGE ON SYNC MODE WHEN PT WENT TO VFIB. BROUGHT THE PRODUCT WITH ALL ACCESSORIES TO THE SHOP. VERIFIED OPERATION OK, CHARGE AND DISCHARGE WITH NO PROBLEM FROM 10 TO 360 JOULES THRU PADDLES AND ALSO THRU DEFIB CABLE. ALSO TRIED TO CHARGE AND DISCHARGE ON SYNC MODE THRU PADDLES AND DEFIB CABLES. OK. WENT TO CATH LAB AND TRIED TO SIMULATE WHAT HAPPENEND WITH DEFIB ANALYZER. FOUND OUT THAT THE WAVEFORM WILL GET SMALLER WHEN THE PT GOES INTO  VFIB FROM NORMAL SINUS RHYTHM, THEN THE SYNC MARKER WILL DISAPPEAR BECAUSE OF THE SIZE OF WAVEFORM AND THE DEFIB WON'T DISCHARGE UNTIL YOU INCREASE THE SIZE AND THE SYNC MARKER COMES BACK. GAVE INSERVICE TO CATH LAB STAFF ON HOW TO CHECK THE DEFIB CABLE WITH THE CABLE TESTER FROM CO. SHOULD BE DONE AT LEAST IN THE BEGINNING OF SHIFT.
GEL IMPLANTS WERE EXPLANTED DUE TO SPHERICAL CONTRACTURE IN BILATERAL BREASTS.
BREAST IMPLANTS WERE EXPLANTED DUE TO BILATERAL CAPSULAR CONTRACTURES.
REASON FOR EXPLANT OF BILATERAL IMPLANTS WAS FOR IMPLANT SIZE CHANGE. PHYSICIAN NOTES STATE "MECHANICAL COMPLICATIONS OF SALINE-FILLED BREAST PROSTHESES" "PROFOUND PSEUDOTOSIS WITH THINNING OF OVERLYING SKIN OF THE ENTIRE POLE (LOWER) OF BOTH BREASTS."
PARAMEDIC ATTACHED MULTI-FUNCTION PADS TO PT AND DEFIBRILLATED TWO TIMES AT 200 J. ON THIRD SHOCK, PARAMEDIC THOUGHT HE SAW A SPARK. SUBSEQUENTLY, MONITOR REPORTED "ELECTRODES OFF" AND WOULD NOT SHOCK. ALL CONNECTIONS PROPERLY ATTACHED. ON ARRIVAL TO THE EMERGENCY DEPT, THE ED MONITOR WOULD NOT SHOCK WITH THE AMBULANCE PADS. PADS WERE CHANGED IN THE ED AND SHOCK WAS ABLE TO BE DELIVERED.
PT HAD BILATERAL BREAST AUGMENTATION IN 1978 WITH SILICONE GEL IMPLANT. IN 1/96 RIGHT IMPLANT WAS BELIEVED TO BE LEAKING GEL. AT THE TIME OF REMOVAL ON 1/8/96, LEFT IMPLANT FOUND INTACT AND RIGHT FOUND RUPTURED.
TWO LASER FIBER TIPS BROKE DURING INTRA-OPERATIVE USAGE.
BUTTON ON CALL CORD BECAME STUCK AFTER SOME LIQUIDS WERE SPILLED ON CORD. THE PT WAS THEREFORE UNABLE TO ACTIVATE THE CALL LIGHT AND SUFFERED A FALL TRYING TO GET OUT OF BED WITHOUT ASSISTANCE.
RIGHT UPPER SIDERAIL ON BED BROKE. PT WAS SLIDING BUT DID NOT FALL, BUT WAS EXTUBATED. DR CAME AND REINTUBATED PT. NO APPARENT INJURY.
VISITOR GOT FOOT CAUGHT IN BED MONITOR WIRE. SHE TRIPPED AND FELL, SHE INJURED LEG AND HEAD.
PORT WAS INSERTED ON 12/21/95. PT READMITTED ON 2/15/96 FOR REMOVAL OF A FRAGMENT FROM THE RIGHT PULMONARY ARTERY, AFTER PT DEVELOPED CELLULITIS AROUND PORT SITE.
DURING NEEDLE BIOPSY OF RIGHT LUNG AS PHYSICIAN WAS OBTAINING SPECIMEN, NEEDLE BROKE OFF FROM HUB. NEEDLE WAS STILL IN PT'S LUNG. PHYSICIAN TRIED TO GET NEEDLE WITHOUT HEMASTAT BUT WAS NOT ABLE TO LOCATE NEEDLE. PT WAS TAKEN FROM CT ROOM TO REMOVE PER CART. UNDER FLUORO, PHYSICIAN WAS ABLE TO LOCATE NEEDLE AND REMOVE NEEDLE FROM LUNG USING A HEMASTAT AND FLUORO. BOX WAS THEN OBTAINED WITH DIFFERENT NEEDLE. PT WAS TRANSFERRED TO ROOM PER CART. PT'S CONDITION REMAINED STABLE THROUGHOUT PROCEDURE.
PT HAD BILATERAL CAPSULAR CONTRACTURE AND RUPTURE OF IMPLANTS. SILICONE GRANULOMA OF LEFT MEDIAL BREAST WAS ALSO NOTED.
PT WAS SCHEDULED FOR REMOVAL AND REPLACEMENT OF SILICONE BREAST PROSTHESIS. ON INITIAL INSPECTION, BOTH RIGHT AND LEFT IMPLANTS WERE TORN AND LEAKING.
FAMILIY WAS ATTEMPTING FEMORAL ACCESS USING SELDINGER TECHNIQUE. INSERTED SHEATH/GUIDE WIRE THROUGH NEEDLE AND ENCOUNTERED RESISTANCE. WITHDREW SHEATH/GUIDE WIRE AND REINSERTED THROUGH NEEDLE AGAIN MEETING RESTISTANCE. ATTEMPTED SECOND WITHDRAWAL OF SHEATH/GUIDE WIRE AND ENCOUNTERED RESISTANCE. UNDER FLUORO FOUND SHEATH COILED IN TISSUE. COMPLETED PROCEDURE USING OTHER LEG. PT THEN SENT TO THE OPERATING ROOM TO HAVE SHEATH SURGICALLY REMOVED.
PT WITH PANCREATITIS NEEDED MULTI-MED CATHETER PLACEMENT FOR CENTRAL TPN. CATHETER PLACEMENT WAS ATTEMPTED. ABOUT TWO-THIRDS OF THE WAY INTO THE VEIN, THE CATHETER COULD NOT BE ADVANCED FURTHER BECAUSE OF APPARENT KINKING OF THE GUIDE WIRE. THE GUIDE WIRE BECAME UNRAVELED AND DIFFICULT TO WITHDRAW. EVENTUALLY, THE WIRE WAS REMOVED AND EXAMINED. THERE WAS NO EVIDENCE OF RETAINED GUIDE WIRE AND CLOSE EXAM OF THE TIP OF THE GUIDE WIRE INDICATED THAT IT PROBLABLY WAS THE TIP AND NO WIRE WAS LEFT IN THE PT. FOLLOWING THIS, A NEW KIT WAS OPENED AND ADVANCED WITHOUT DIFFICULTY. THE NEW GUIDE WIRE WAS WITHDRAWN WITHOUT DIFFICULTY.
ON 3/15/96 AT 1105 PT HAD CORONARY ARTERY BYPASS GRAFTS FIVE TIMES, MITRAL VALVE REPLACEMENT AND AORTIC VALVE REPLACEMENT. IABP WAS FUNCTIONING PROPERLY. ON 3/16/96 AT 0800 NURSES IN ICU NOTED IABP CATHETER MALFUNCTIONING, AT 0900 INTRA-AORTIC BALLOON CATHETER WAS FOUND TO BE RUPTURED. BLOOD WAS FOUND TO BE IN EXTENSION LINE. CATHETER WAS REMOVED AND NEW ONE INSERTED INTO LEFT FEMORAL ARTERY.
HALOTHANE VAPORIZER, WHEN SET ON 1%, DELIVERED 16% PER GAS MONITOR. VENTILATOR WAS PROPERLY CALIBRATED AND FUNCTIONING PROPERLY. PT'S HEART RATE DECREASED AND PT WAS UNABLE TO VENTILATE. PT INTUBATED AND CPR STARTED. ATROPINE, SUCCINYLCHOLINE, AND EPINEPHRINE WERE ADMINISTERED. PT RECOVERED AND SURGERY WAS CANCELED. SURGERY WAS SUCCESSFULLY COMPLETED ON 3/8/96. AT THIS TIME NO PERMANENT INJURY IS KNOWN.
MD ORDERED EXTUBATION. PT WAS VERY COMBATIVE. NURSE TORE OFF ET CUFF AND CLIPPED TAPE HOLDING ET TUBE IN PLACE AND ET HOLDER ATTACHING TUBE TO UPPER LIP. PT WAS EXTUBATED AND PLACED ON MIST. PT CLAMPED TEETH DOWN ON ET HOLDER AND HOLDER CAME OFF TUBE DURING REMOVAL AND WAS NOT NOTED BY NURSE. FOLLOWING DAY, PT WAS IN MORE DISTRESS AND RE-INTUBATED BY ANESTHESIOLOGIST. ET HOLDER WAS FOUND IN THE UPPER AIRWAY.
FACILITY CHANGED CVP PRESSURE SET UP. PRIOR TO CHANGE, WAVEFORM WAS GOOD. AFTER CHANGE, FACILITY NOTED A LEAK AT THE FAST FLUSH CONNECTOR. SET WAS DISCONNECTED, 2ND SET PUT UP AND IT CAUSED THE MONITOR TO BLANK OUT. BIOMED RESEARCHED MONITOR AND CHECKED SYSTEM AND FOUND NO MALFUNCTION WITH SYSTEM. 2ND SET DISCONTINUED AND ENTIRE PRESSURE SET REPLACED. 3RD SET WORKING FINE, GOOD CVP WAVEFORM PRESENT. TUBING SETS 1 & 2 GIVEN TO NURSE MANAGER.
THERE WAS NOISE ON THE STORED ELECTROGRAMS CAUSED BY A FRACTURE IN THE SENSE PACE LEAD. ON 2/13/96, THE LEADS WERE CAPPED. THERE IS NO INDICATION THAT THE GENERATOR DID NOT PERFORM TO SPEC.
PT WAS PREPPED FOR AN EXTRA CAPSULAR PROCEDURE. THE CORTEX GOT SUCKED INTO THE IRRIGATION PORT AND WOULD NOT RELEASE. A CAPSULAR TEAR RESULTED WHICH REQUIRED AN ANTERIOR VITRECTOMY. THE PT IS DOING WELL. THIS TYPE OF MALFUNCTION OCCURRED THREE OTHER TIMES. THERE WERE NO INJURIES IN ANY OF THESE INCIDENTS. THE FACILITY WILL NOT BE FILING A MEDWATCH REPORT.
BLOOD LEAK OCCURRED DURING DIALYSIS. DIALYZER WAS REPLACED. TREATMENT CONTINUED WITH NO REPORTED PROBLEM. EBL WAS GREATER THAN 100CC.
FACILITY ALLEGES BLOOD LEAK. DIALYZER WAS REPLACED AND TREATMENT REINITIATED. NO FURTHER PROBLEMS WERE REPORTED.
FACILITY ALLEGES AN ARTERIAL HEADER LEAK. EBL 200CC. NO PT INJURY REPORTED.
DR ATTEMPTED TO CUT TROCHLEAR RECESS, BLADE JAMMED ON CUTTING GUIDE SEVERAL TIMES CAUSING LOCKING RING SUPPORT TO BREAK, PIECE BROKE OFF ON THE OR FLOOR.
THE SENSE/PACE LEAD WAS OVERSENSING. ON 2/5/95, THE SENSE/PACE LEADS WERE CAPPED. THERE IS NO INDICATION THAT THE GENERATOR WAS NOT PERFORMING TO SPEC.
THERE WAS SILICONE ADHESIVE MISSING FROM THE SET SCREW WELL AT THE ADAPTER WHICH MAY HAVE CONTRIBUTED TO A SENSING MALFUNCTION. ON 2/15/96 THE ADAPTER WAS REMOVED. THERE IS NO INDICATION THAT THE GENERATOR DID NOT PERFORM TO SPEC.
DR TRIED UNSUCCESSFULLY TO SNAP INSERT INTO CUP. INSERT KEPT POPPING OUT. WAS ABLE TO SUCCESSFULLY IMPLANT SECOND AVAILABLE INSERT.
DISTRIBUTOR RECEIVED AN EXPLANT REPORT DETAILING AN ELECTIVE EXPLANT OF GENERATOR AND S/P LEAD DUE TO POST-OP NOISE. ATTEMPTS TO REPRODUCE THE NOISE IN THE OR WERE UNSUCCESSFUL. THE GENERATOR AND SENSING/PACING LEAD WERE REPLACED.
PT WORE THROUGH ACETABULAR LINER. 32MM HEAD, SMALL LINER, 46/49, HEAVY PT, 15DEG HOOD, ALL CAUSED ACCELERATED WEAR.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED.
PT PRESENTED WITH MILD PAIN AND PALPABLE CREPITUS, FILMS WERE TAKEN AND POLY APPEARED THIN. KNEE WAS OPENED AND POLY WAS EXCHANGED ALONG WITH PATELLA DUE TO WEAR.
THE TIBIAL INSERT WAS REMOVED DUE TO POLY WEAR AND REPLACED WITH AN 11MM MEDIUM.
DELAMINATION OF BOTH TIBIAL AND PATELLA POLY. LOOSE PRESS FIT PATELL. REPLACED TIBIAL INSERT AND PATELLA.
TEAR OF MEDIAL COLLATERAL LIGAMENT ABOUT A YEAR AGO AND PT DEVELOPED MEDIAL INSTABILITY CAUSING PATELLA TO WEAR ABNORMALLY. THE PATELLA AND TIBIAL INSERT WERE REMOVED AND REPLACED BECAUSE OF PLASTIC WEAR.
CO RECEIVED AN EXPLANT REPORT DETAILING AN ELECTIVE EXPLANT OF GENERATOR AND S/P LEAD DUE TO POST-OP NOISE. ATTEMPTS TO REPRODUCE THE NOISE IN THE OR WERE UNSUCCESSFUL. THE GENERATOR AND SENSING/PACING LEAD WERE REPLACED.
DURING THE PROCEDURE DR EXPERIENCED PROBLEMS WITH THE LAPAROSCOPE, LIGHT SOURCE AND INSUFFLATOR WHICH RESULTED IN IMPAIRED VISION AND COMPROMISED PERITONEAL SPACE. NEVERTHELESS, HE PLACED FOUR TROCARS AND ATTEMPTED TO PLACE A FIFTH. WHILE PLACING THE LAST TROCAR IN THE UPPER RIGHT QUADRANT, THE TROCAR PENETRATED THE LINING OF THE STOMACH. DUE TO THE BLEEDING CAUSED FROM THE INJURY AND THE INADEQUATE INSUFFLATION AND VISIBILITY, DR COULD NOT ASSESS THE EXTENT OF THE DAMAGE LAPAROSCOPICALLY SO HE DECIDED TO OPEN THE PT. DR ASSURED THAT THE TROCAR WAS NOT TO BLAME FOR THE EVENT. HE EXPLAINED THAT THE INSUFFLATION AND VISUALIZATION WERE BAD AND THAT IT WAS AN "IMPRUDENT" DECISION ON HIS PART TO PUT THE TROCAR IN.
FACILITY ALLEGES PT REACTION DURING DIALYSIS. DON REPORTED REACTION OCCURRED 15 MIN INTO DIALYSIS, WHEN NEW DRY DIALYZER WAS USED AFTER WET PACK CLOTTED. PT C/O SOB. TREATMENT STOPPED AND PT TRANSFERRED TO HOSP. RETURNED FOR NEXT DIALYSIS WITHOUT PROBLEM.
FACILITY ALLEGES PT REACTION DURING DIALYSIS. CHIEF TECH REPORTS THAT SHORTLY AFTER INITIATION OF TREATMENT, PRIOR TO BLOOD COMING IN CONTACT WITH DIALYZER, PT EXPERIENCED RESPIRATORY ARREST.
CO RECEIVED A REPORT OF AN ALLEGED MALFUNCTION. NO OTHER INFO ON THE DEVICE OR ANY POSSIBLE INVOLVEMENT OF PRODUCT IN THE ALLEGED INJURY IS AVAILABLE AT THIS TIME.
A 29-YR-OLD MALE WITH STATUS EPILEPTICUS UNDERWENT A CRANIOTOMY FOR PLACEMENT OF SUBDURAL EEG ELECTRODES. AFTER COMPLETION OF PROCEDURE AND TRANSFER OF PT TO ICU BED, VENTILATION WAS RE-INITIATED USING THE PT'S BEDSIDE MANUAL RESUSCITATOR. AFTER 3-4 UNEVENTFUL BREATHS, VENTILATION BECAME DEFFICULT; HYPOXEMIA, HYPOTENSION, AND BRADYCARDIA OCCURRED WITHIN 1-2 MIN DESPITE CHANGING VENTILATION DEVICES. NEEDLE THORACOSTOMY OF THE RIGHT CHEST REVEALED AIR ESCAPE AND LED TO IMEDIATE RESOLUTION OF SIGNS. A CHEST TUBE WAS PLACED. CLINICAL DIAGNOSIS: RIGHT TENSION PNEUMOTHORAX. EXAMINATION OF THE VENTILATING DEVICE REVEALED COPIOUS SECRETIONS IN THE NON-REBREATHING AND PEEP VALVE HOUSING. RESUSCITATOR FUNCTION RETURNED TO NORMAL ONLY AFTER JOSTLING THE SPRING - LOADED PEEP VALVE INTO MOBILITY. (*)
AFTER RE-INTUBATION OF A SELF-EXTUBATED ICU PT, VENTILATION WAS PROVIDED USING THE PT'S BEDSIDE MANUAL RESUSCITATOR. CHEST EXPANSION OCCURRED WITH THE FIRST BREATH BUT WAS DIFFICULT TO PRODUCE WITH SUBSEQUENT BREATHS, EXHALED CAPNOMETRY WAS EQUIVOCAL FOR CO2, REPEAT DL REVEALED THE ENDOTRACHEAL TUBE TO BE IN THE TRACHEA. USE OF THE SAME RESUSCITATOR LED TO THE SAME FINDINGS. AFTER DISASSEMBLY OF THE PEEP VALVE AND EXTRACTION OF THE SPRING-LOADED DISC, THE DEVICE FUNCTIONED NORMALLY AND VENTILATION WAS ACHIEVED. IT APPEARED THAT THE PEEP VALVE DISC WAS "GLUED" IN A CLOSED POSITION BY PT SECRETIONS. (*)
PT TO EMERGENCY DEPT WITH ACUTE MYOCARDIAL INFARCTION. TPA (90 MIN PROTOCOL) ORDERED. SALINE LOCK ESTABLISHED TO RIGHT INNER WRIST WITH #20 BY RN. TPA 15 MG IV BOLUS GIVEN THEN INFUSION STARTED VIA MFR'S IV PUMP BY RN. ONE HR LATER PUMP ALARM SOUNDED, SHOWING LARGE INFILTRATION TO RIGHT FOREARM. IV DISCONTINUED AND COMPRESSION DRESSING APPLIED. IV WAS INFUSING AT 35 MG/HR. MOST OF TPA INFILTRATED INTO TISSUES. INSTRUCTIONS GIVEN FOR CARE OF IV INFILTRATE SITE. SURGICAL CONSULT DONE PER INSTRUCTIONS OF DRUG MFR. PUMP REMOVED FROM SVC IMMEDIATELY.
THE PT SAT ON THE COMMODE AND THE COMMODE COLLAPSED. THE PT DID NOT FALL. HUSBAND CAUGHT PT BEFORE SHE HIT THE FLOOR. MFR HAS CONCLUDED THAT THE PRODUCT WAS MFG BETWEEN 10/26/92 AND 11/2/92.
RPTR HAD SURGERY FOR SCOLIOSIS 2/26/93. MONTHS AFTER SURGERY SHE DEVELOPED SORES ON HER BACK AND BLEEDING. SHE HAD A FEELING IT WAS THE HARDWARE BURNING HER BACK. SHE TRIED TO GET A SAMPLE FROM THE MFR. THEY WOULD NOT GIVE IT TO HER. FINALLY, THE DOCTOR GAVE HER A SAMPLE OF THE ROD. THE ALLERGIST DID METAL TESTING TWO DAYS. THE OUTCOME WAS ALLERGIES TO NICKEL AND EPOXY RESIN. FINALLY, AFTER TWO YEARS OF NO ONE BELIEVING HER. SHE HAD THE PROOF FROM THE ALLERGIST. NOW THE DR AGREES TO REMOVE THE HARDWARE. THE ALLERGIST IS STILL DOING BLOOD WORK TO SEE IF THERE ARE ANY METAL TRACES IN THE BODY OR ANY AUTOIMMUNE DISEASE.
ON 12/20/93 WE WERE NOTIFIED BY THE HOSPITAL THAT NO AUDIBLE ALARM WAS HEARD WHEN THE PT WAS DISCONNECTED FROM THE VENTILATOR IN THE EARLY HRS OF 12/18/93.  THE PT WAS "BAGGED" AND SWITCHED TO ANOTHER VENTILATOR.  THE HOSPITAL STATED ALTHOUGH THE PT HAD BRADYCARDIA, HE/SHE RECOVERED WITH NO SIGNS OF COMPROMISE.
ON 12/22/93 WE WERE NOTIFIED BY THE HOSPITAL THAT THE DEFIBRILLATOR FAILED TO FUNCTION PROPERLY ON A PT.  THE HOSPITAL ALSO INFORMED US THAT A SECOND DEFIBRILLATOR WAS AVAILABLE AT THE TIME AND USED ON THAT PT.  WE WERE INFORMED BY THE HOSPITAL THAT THIS PT DIED SUBSEQUENTLY BUT WERE NOT MADE AWARE OF THE CAUSE OF DEATH.
ON 1/6/94 WE WERE NOTIFIED BY THE HOSPITAL THAT THE VENTILATOR FAILED TO FUNCTION PROPERLY ON A PT ON 12/13/93.  THE HOSPITAL ALSO INFORMED US THAT THE PT WAS BRIEFLY "BAGGED" AND THEN SWITCHED TO ANOTHER VENTILATOR WAS PREVIOUSLY RETURNED TO US ONLY WITH A NOTE THAT IT HAD MALFUNCTIONED.
ON 1/13/94 WE WERE NOTIFIED BY THE HOSPITAL THAT THE VENTILATOR STOPPED CYCLING WHILE ON A PT, ALTHOUGH THE APNEA ALARM DID SOUND.  THE HOSPITAL ALSO INFORMED US THAT THE PT WAS "BAGGED" AND SWITCHED TO ANOTHER VENTILATOR WITH NO SIGNS OF COMPROMISE.
ON 1/17/93 WE WERE NOTIFIED BY THE HOSPITAL THAT THE VENTILATOR OVERHEATED AND STOPPED WHILE CONNECTED TO A PT.  THE HOSPITAL ALSO INFORMED US THAT THE PT WAS BRIEFLY "BAGGED" AND THEN SWITCHED TO ANOTHER VENTILATOR WITHOUT ANY PROBLEM.
ON 2/3/94 WE WERE NOTIFIED BY THE HOSPITAL THAT THE VENTILATOR BECAUSE LOUD, WAS GENERATING HEAT, AND STOPPED WORKING WHILE ON A PT.  THE HOSPITAL ALSO INFORMED US THAT THE PT WAS "BAGGED" ANAD SWITCHED TO ANOTHER VENTILATOR WITH NO SIGNS OF COMPROMISE.  ON 2/11/94 WE WERE TOLD THAT THE PT IS NOW OFF THE VENTILATOR AND IS DOING FINE.
PT IS AN 86-YR-OLD MALE SUFFERING FROM CHRONIC RENAL FAILURE AND RECEIVING CHRONIC DIALYSIS. HE HAS UNDERGONE MULTIPLE ACCESS PROCEDURES. IN 11/94 A PTFE ARTERIOVENOUS SHUNT WAS REVISED. DUE TO RECENT FINDINGS OF INCREASING VENOUS RPESSURE AND SIGNIFICANT RECIRCULATION PROBLEMS, IMMINENT GRAFT FAILURE WAS SUSPECTED. AN ARTERIOGRAM WAS CONDUCTED THROUGH THE SHUNT ON 3/12/96. VENOUS STENOSIS WAS NOTED. BALLOON ANGIOPLASTY WAS PERFORMED, BUT WAS NOT SUCCESSFUL IN RELIEVING THE ENTIRE STENOTIC AREA. AN ATHRECTOMY OF THE AREA WAS ATTEMPTED. DURING THE ATHRECTOMY, THE CATHETER BROKE, REQUIRING VENOUS PUNCTURE THROUGH THE GROIN TO REMOVE THE CATHETER FRAGMENT. THE BREAKAGE OCCURRED DURING REMOVAL OF THE CATHETER. THERE WAS DISLODGEMENT OF THE CUTTING SEGMENT AS WELL AS THE STORAGE SEGMENT DISTALLY FROM THE CATHETER.
ELECTIVE PTCA PT DEVELOPED VFIB DURING BALLOON INFLATION. DEFIBRILLATOR SET TO CHARGE TO 200. CHARGED TO ONLY 120 X 2. WOULD NOT DISCHARGE. RESET AT 300, CHARGED AND FIRED. SYNCH BUTTON NOT ON. HAD TESTED APPROPRIATELY THAT MORNING. DELAY IN DEFIBRILLATION DUE TO MALFUNCTION ESTIMATED AT 1-1.5 MIN. BIOMED UNABLE TO DUPLICATE PROBLEM IN LAB.
STAPLER DID NOT "FIRE" COMPLETELY AND STUCK TO TISSUE. FIRING MECHANISM SEEMED TO "JAM". ANOTHER INSTRUMENT OPENED AND USED.
RPTR C/O ORAL ULCERS, HEADACHES, FATIGUE, MUSCLE PAIN, WEAKNESS, MORNING STIFFNESS, RAPID HAIR LOSS, MEMORY LOSS, LOSS OF CONCENTRATION, PAIN AND STIFFNESS IN HANDS, FINGERS, KNEES, ANKLES AND FEET, NECK AND UPPER TORSO, SENSITIVE TO COLDS, POLYARTHRITIS, PHOTOSENSITIVITY (NO RASH), LYMPHADENOPATHY, ESOPHAGEAL MOBILITY DISORDER, HISTORY OF RAYNAUD'S AND FATIGUE.
ROUND GEL BREAST IMPLANTS PLACED 10/78. PT DID NOT REALIZE RUPTURE HAD OCCURRED AND NONE OF THE MAMMOGRAMS SHOWED THE RUPTURE. OPERATIVE REPORT STATES RIGHT IMPLANT HAS AN INTRACAPSULAR RUPTURE AND LEFT IMPLANT WAS RUPTURED AT TIME OF EXPLANT. PT NOW HAS ANA TITER OF 1:320 AND ATYPICAL CONNECTIVE TISSUE DISEASE.
GUIDE WIRE IN 8.5 FRENCH QUAD LUMEN KIT WAS NOT WRAPPED TIGHTLY AND WAS NOT USABLE WHEN KIT WAS OPENED. NO HARM TO PT. NEW KIT USED AND ALL OK.
DR WAS EXPOSED TO BLOOD BEING TRANSFUSED WHEN THE IV TUBING DISCONNECTED FROM THE PRESSURE PUMP DUE TO A MFG DEFECT.
PT S/P ROTATOR CUFF REPAIR UNDERGOING ELECTRICAL STIMULATION USING UNIT VIA PIN ELECTRODES 4 TIMES. THERAPIST HIT THE IFC CURRENT BUTTON AND INSTEAD OF IT INCREASING IN SMALL INCREMENTS, IT "SHOT UP" TO 16-18 MA. SESSION COMPLETED. AS PT WAS PREPARING TO LEAVE, SHE BEGAN TO SHAKE UNCONTROLLABLY AND WAS SUBSEQUENTLY TRANSPORTED VIA AMBULANCE TO ER WHERE SHE WAS TREATED AND RELEASED. EKG AND LABS WNL WITH EXCEPTION OF 1+ BLOOD IN URINE.
ON 2/2/94 WE WERE NOTIFIED BY THE HOSPITAL THAT THE VENTILATOR STOPPED WORKING WHILE CONNECTED TO A PT THAT WAS RECOVERING FROM HEART SURGERY.  THE HOSPITAL ALSO INFORMED US THAT THE PT WAS BRIEFLY "BAGGED" AND THEN SWITCHED TO ANOTHER VENTILATOR.  ON 2/11/94, WE WERE INFORMED BY THE HOSPITAL THAT THE PT HAS COMPLETELY RECOVERED FROM THE SURGERY AND DOES NOT HAVE ANY KIND OF INJURY OR IMPAIRMENT.
ON 2/2/94 WE LEARNED FROM THE HOSPITAL THAT ON 1/19/94 THE VENTILATOR FAILED TO WORK PROPERLY ON A PT AFTER A POWER SURGE IN THE HOSPITAL ELECTRICAL SYSTEM.  THE HOSPITAL TOLD US THAT THE VENTILATOR WOULD NOT POWER UP AFTERWARDS AND A BURNING SMELL AND SMOKE WERE DETECTED BY THE CLINICAL STAFF.  THE HOSPITAL ALSO STATED THE PT HAD TO BE "BAGGED" AND PLACED ON ANOTHER VENTILATOR, AND THE PT IS FINE NOW.
ON 2/16/94 WE LEARNED FROM THE HOSPITAL THAT A HISSING SOUND WAS HEARD FROM VENTILATOR WHEN IT WAS TESTED PRIOR TO BE USED ON A PT.  THE HOSPITAL TOLD US THAT THE VENTILATOR COULD NOT GENERATE ENOUGH PRESSURE TO VENTILATE THE PT SO THE PT WAS "BAGGED" AND PLACED ON ANOTHER VENTILATOR.  THE HOSPITAL ALSO STATED THE PT WAS NOT AFFECTED.
ON 2/17/94 WE LEARNED FROM THE HOSPITAL THAT A LOUD POP AND THEN HISSING SOUND WAS HEARD FROM THE VENTILATOR WHEN IT WAS BEING USED ON PT.  THE HOSPITAL TOLD US THAT THE PT WAS "BAGGED" AND PLACED ON ANOTHER VENTILATOR, AND THE PT WAS NOT INJURED.
ON 3/4/94 WE WERE INFORMED BY THE HOSPITAL THAT THE VENTILATOR CEASED TO FUNCTION WHILE ON A PT, AND IT DISPLAYED "POWEWR FAILURE" ON THE PANEL.  THE HOSPITAL TOLD US THAT THE PT WAS BAGGED AND SWITCHED TO ANOTHER VENTILATOR WITHOUT ANY SIGN OF INJURY.  ON 3/10/94 WE WERE TOLD THAT THE PT IS DOING FINE.
ON 3/18/94 WE LEARNED FROM THE HOSPITAL THAT THE VENTILATOR "JUST STOPPED" WHILE ON A PT.  THE HOSPITAL TOLD US THAT THE PT WAS "BAGGED" AND PLACED ON ANOTHER VENTILATOR, AND THE PT WAS NOT INJURED.
ON 3/22/94 WE LEARNED FROM THE HOSPITAL THAT THE VENTILATOR MALFUNCTIONED WHILE ON A PT.  THE HOSPITAL REPORTED THE PRESSURE DROPPED TO ZERO AND A LOUD HISSING NOISE WAS HEARD.  THE HOSPITAL TOLD US THAT THE PT WAS SWITCHED TO ANOTHER VENTILATOR, AND THE PT WAS NOT INJURED.  ON 3/30/94 THE HOSPITAL CONFIRMED THAT THE PT WAS DOING FINE.
ON 3/16/94 WE LEARNED FROM THE INSTITUTE THAT THE VENTILATOR MALFUNCTIONED WHILE ON A PT WHO WAS BEING TRANSFERRED FROM A PHYSIOTHERAPY SESSION BACK TO THE PT'S RM.  THE INSTITUTE REPORTED THE UNIT COULD NOT DELIVER VOLUME SET AND THEY COULD NOT SET THE FLOW BELOW 70 LPM, BUT THE PT WAS NOT INJURED.  WHEN OUR INITIAL TESTING RESULTS WERE REPORTED BACK TO THE INSTITUTE, WE WERE TOLD ON 4/7/94 THAT THE PT ACTUALLY HAD TO BE "BAGGED" UNTIL HE/SHE COULD BE PUT ON AN ADULT VENTILATOR INSIDE THE PT'S RM.
ON 6/3/94 WE LEARNED FROM THE HOSPITAL THAT THE VENTILATOR FAILED TO WORK PROPERLY ON A PT.  THE HOSPITAL TOLD US THAT THE PT HAD TO BE "BAGGED" AND PLACED ON ANOTHER VENTILATOR, BUT WAS NOT AFFECTED.  WE WERE LATER TOLD THAT THE PT WAS OFF THE VENTILATOR ON THE NEXT DAY.
PT PRESENTED TO PHARMACY ON 4/9/96, WITH C/O LEFT ARM BEING SWOLLEN AND HAVING A COLOR CHANGE. A SINGLE LUMEN CATHETER WAS INSERTED INTO THE CEPHALIC VEIN ON 3/22/96. ULTRASOUND OF ARM ACCOMPLISHED ON 4/9/96, CLOT FOUND IN ARM, ORIGINATING AT POINT OF ENTRY UP TO THE SUBCALVIAN VEIN. CATHETER REMOVED WITH MD ASSISTANCE. PT HOSPITALIZED ON 4/9/95 FOR HEPARIN THERAPY ALSO ON COUMADIN 5 MG/DAY.
A REVISION TOTAL HIP SURGERY WAS PERFORMED ON THE PT FOR STEM LOOSENING AND PAIN. WHEN THE SURGEON REMOVED THE STEM, HE NOTED THAT THE DISTAL TIP OF THE STEM HAD FRACTURED. THE SURGEON STATED THAT HE THOUGHT THE PROXIMAL PORTION OF THE STEM WAS LOOSE WHILE THE DISTAL TIP WAS STILL WELL FIXED, AND THIS CAUSED THE STEM TO BREAK OVER TIME.
RESIDENT SITTING IN DINING ROOM IN CHAIR. LABORED BREATHING WAS NOTED. FACE WAS CYANOTIC WITH CHIN TOWARDS CHEST WITH RIM OF BRACE HOLDING HER CHIN DOWN AND ALSO COVERING HER NOSE. BRACE REMOVED AND RESIDENT POSITIONED FOR OPEN AIRWAY. COLOR BECAME MUCH IMPROVED AS RESIDENT WAS BREATHING ON HER OWN. CNA APPLIED NECK COLLAR AS INSERVICED. COLLAR WAS REMOVED AND PLACED IN DR'S OFFICE UNTIL FURTHER INVESTIGATION BY OT DEPT.
PT WAS HOSPITALIZED WITH A BLOOD SUGAR OF 510. TWO CARTRIDGES MAY BE LEAKING AROUND THE BLUE PLUNGER BECAUSE THERE WAS INSULIN AROUND THE PLUNGER. DISCARDED CARTRIDGE WAS ALSO WET AROUND THE PISTON ROD. PT BELIEVES THE PUMP IS RUNNING CORRECTLY. PT IS OUT OF THE HOSP NOW AND WILL SEND THE ONE CARTRIDGE AND PISTON ROD IN FOR EVALUATION.
AFTER TUBING CLAMPED PER DEVICE INSTRUCTION IT "SEALED" TOGETHER. ACCESS WAS CLOSED AND DIALYSIS COULD NOT BE PERFORMED. CATHETER WAS DISCONTINUED AND "NEW" CATHETER INSERTED.
METAL BACKED PATELLA FAILURE; SEPARATION OF THE POLY FROM THE METAL BACK. ARTICULAR SURFACE DEFORMED.
SINCE 1/25/95, FACILITY HAS HAD 9-10 PTS EXPERIENCE ALLERGIC REACTIONS SUCH AS HEMOLYSIS, PAIN AT NEEDLE SITE, NAUSEA, VOMITING, LYMPH NODE  SWELLING. SUSPECT REACTION TO DISINFECTANT.
A NURSE REPORTED THAT A PT BEGAN TAKING COUMADIN 2.5 MG FIVE DAYS A WEEK AND 5 MG TWO DAYS A WEEK APPROX ONE YEAR AGO FOR ATRIAL FIBRILLATION AND CVA (CEREBROVASCULAR ACCIDENT). ON THE MORNING OF 11/30/94, HER PT (PROTHROMBIN TIME) WAS 15.0 SECONDS USING A TEST SYSTEM MONITOR IN THE PHYSICIAN'S OFFICE. THE TEST WAS REPEATED USING A SECOND SITE, WITH A RESULT OF 18.6 SECONDS. THE PT COMPLAINED OF NOSEBLEEDS OF AND ON. COUMADIN DOSAGE WAS REDUCED TO 2.5 MG QD. ON THE NIGHT OF 11/30/94, SHE WAS ADMITTED TO THE HOSP VIA THE ER (EMERGENCY ROOM) FOR ABDOMINAL PAIN UNRELATED TO BLEEDING. PT WAS APPROX 50 SECONDS IN THE HOSP LAB. THE NURSE PRESUMED THAT COUMADIN WAS DISCONTINUED. ON THE MORNING OF 12/1/94, HER PT WAS STILL APPROX 50 SEC. A MEMBER OF THE HOSP LAB STAFF INDICATED THAT THIS PT'S PTS HAD BEEN IN THE 40-50 SEC RANGE AND THAT, AS OF 12/2/94, HER PT WAS BACK DOWN TO ABOUT 20 SEC. THE MONITOR HAD BEEN OPERATED BY THE PHYSICIAN'S OFFICE STAFF. PROPER TECHNIQUES AND USE OF CONTROLS WERE CONFIRMED WITH TWO OF THE STAFF NURSES. ONE NURSE INDICATED THAT THE MONITOR IS GENERALLY UNPLUGGED WHEN USED. SHE NOTED THAT WHEN UNPLUGGED FOR LESS THAN 30 MIN, THE MONITOR INDICATES THAT THE BATTERY IS LOW. NO OTHER PROBLEMS WITH THE MONITOR WERE STATED. SHE NOTED THAT THERE WERE NO PROBLEMS WITH ANY OTHER PT. THE OTHER NURSE STATED THAT THE PHYSICIAN HAS LOST CONFIDENCE IN THE MONITOR BECAUSE OF THE LACK OF CORRELATION BETWEEN THE MONITOR AND THE HOSP LAB PT RESULTS FOR THIS PT. A REPLACEMENT MONITOR WAS PROVIDED AND WAS CONFIRMED TO BE PERFORMING PROPERLY. THE MONITOR IN QUESTION WILL BE RETURNED TO THE MFR FOR EVALUATION. 5/10/95 THE NURSE CLARIFIED THAT THE PT HAD BEEN TAKING COUMADIN SINCE PRIOR TO 1989 FOR CHRONIC ATRIAL FIBRILLATION. PROTIMES (PROTHROMBIN TIMES, PTS) WERE MONITORED MONTHLY AND HAD RANGED FROM 17 TO 19. ON 11/30/94, THE PT WAS 18.6 ON A COUMADIN REGIMEN OF 2.5 MG QD WITH 5 MG ON THRUSDAYS. ON 12/1/94, THE PT WAS SEEN IN THE HOSP FOR ACUTE ABDOMINAL AND FLANK PAIN WITH A PT OF 56 AND A PTT (PARTIAL THROMBOPLASTIN TIME) OF 111. COUMADIN WAS HELD ON THAT DATE, AND VITAMIN K 10 MG WAS GIVEN IM (INTRAMUSCULARLY). ON THE MORNING OF 12/2/94, PT WAS 15.7, AMD COUMADIN WAS RESUMED AT 1.25 MG QD. DIAGNOSIS AT DISCHARGE ON 12/2/94 WAS RENAL COLIC. THE NURSE REPORTED THAT QUALITY CONTROL CHECKS ON THE MONITOR (11/30/94) AND ON THE CARTRIDGES (DATE OF TEST NOT PROVIDED) WERE "OKAY."
PORT EXPLANTED 2/15/95. PT HAD FOLLOW-UP CHEST X-RAY 3/14/95 WHICH REVEALED CATHETER SHEAR. CATHETER TIP OVERLYING RIGHT ATRIUM. RADIOLOGIST RETRIEVED EXCESS CATHETER 3/23/95. PT DOING WELL.
DIFFICULTY WITH REMOVAL, TEMPORARY AIRWAY OBSTRUCTION.
PCA PUMP SET TO INFUSE 5 MG BOLUS DEMEROL EVERY 10 MIN. PT RECEIVED COMPLETE 300 MG DEMEROL OVER SHORT PERIOD OF TIME. MEDICATIONS HAD TO BE GIVEN TO REVERSE THE ADVERSE REACTIONS OF THE OVERDOSE OF DEMEROL. PCA PUMP INITIALLY STARTED ON 9/21/93 AFTER SURGERY.
PT CAME IN FOR REGULARLY SCHEDULED DIALYSIS TREATMENT. MACHINE WAS USED FOR TREATMENT. DURING TREATMENT THE PT RECEIVED TWO (2) UNITS OF PACKED RED BLOOD CELLS FOR TREATMENT OF LOW HEMATOCRIT. THE PT TOLERATED THE TREATMENT AND TRANSFUSION WITHOUT PROBLEMS. TREATMENT WAS DISCONTINUED AT 2:10 PM. SHORTLY AFTER TREATMENT ENDED THE PT'S TEMP BEGAN RISING. BLOOD TRANSFUSION REACTION WAS SUSPECTED. THE PHYSICIAN WAS NOTIFIED AND ORDERS OBTAINED FOR MEDICATION AND BLOOD CULTURES. THE PT'S CONDITION CONTINUED TO WORSEN AND PARAMEDICS WERE CALLED. THE PT WAS TRANSPORTED TO ER. THE PT WAS ADMITTED TO THE HOSP FOLLOWING ER CARE. THE DIAGNOSIS WAS ANAPHYLACTIC SHOCK. ON 2/21/94, THE BIOMEDICAL DEPT WAS NOTIFIED OF THE BLOOD CULTURE RESULTS. BACTERIAL COUNTS FOR MACHINE AND WATER SYSTEM WERE REQUESTED. CO CHECKED OUT THE SYSTEM AT THE UNIT. NO PROBLEMS WERE DISCOVERED.
PT RECEIVED A BOVIE BURN ABOUT THE SIZE OF 1 1/2 CM X 1 1/2 CM ON THE ABDOMEN. THE BOVIE CORD HAD A LOOSE INSULATOR CAP AND THIS BECAME DISCONNECTED DURING SURGERY. THE INCIDENT WAS REPORTED TO AN ASSISTANT NURSE MGR AND THE CORD WAS REMOVED AND REPLACED.
THE PT FIRST HAD ARTIFICIAL SPHINCTER PLACED ON 9/27/94. SURGERY WAS REDONE ON 12/1/94 TO REMOVE THE PUMP FROM THE SCROTUM. THERE WAS NOTED TO BE AIR IN THE PUMP AND THE PUMP DID NOT WORK. AT THIS TIME, THE PUMP WAS REPLACED.
DURING THE PROCEDURE (CATHETER INSERTION INTO CENTRAL VEIN) THE SHEATH OF THE DEVICE DID NOT TEAR/SPLIT EVENLY. RESULTED IN A PEELED OFF FRAGMENT AND A SECTION OF THE SHEATH STILL AROUND THE CATHETER. A SECOND INTRODUCER KIT WAS USED WITHOUT PROBLEMS. NO PT INJURY WAS REPORTED. NO INFO IS AVAILABLE.
DOUBLE LUMEN PERIPHERALLY-INSERTED CENTRAL CATHETER WAS PARTIALLY PULLED OUT BY PT. PIGTAILS OF DOUBLE LUMEN CATHETER WERE BOTH BROKEN AT THE BIFURCATION OF THE "Y" ON THE PICC TUBING. DOES NOT APPEAR CUT. ROUGH EDGES APPEAR BROKEN. RPTR WOULD NOT THINK BOTH PIGTAILS WOULD BREAK.
THE METAL SHAFT OF THE ORAL (BLUE) TEMP PROBE CAN LOOSEN FROM THE WHITE PLASTIC BODY CAUSING THE SHAFT TO BECOME LONGER. THIS CAUSES THE SPRING TENSION ON THE EJECT BUTTON TO INCREASE TO THE POINT THAT IT MAY (IT DID AT RPTR'S FACILITY) RELEASE ON ITS OWN. THE EJECTED PROBE COVER HAS THE POTENTIAL TO CAUSE INJURY TO THE PT.
PT IS 2 YEARS STATUS POST A LEFT TOTAL KNEE REPLACEMENT. ABOUT 1 MONTH AGO SHE SLIPPED AND HAD A SEVERE TORQUE TO LEFT KNEE. SHE WAS TREATED WITH KNEE IMMOBILIZER AND CONTINUED TO C/O X-RAYS REVEALED FAILURE OF TIBIAL POLY SPACER WITH ANTERIOR SUBLUXATION. IN OPERATING ROOM ON 3/12 IT WAS APPARENT THAT THE ANTERIOR MEDIAL ASPECT OF THE TIBIAL POLY SPACER HAD BEEN DISRUPTED AND WAS IN PIECES.
A "DONOR SELF-EXCLUSION BARCODE" IS A SET OF TWO BARCODED LABELS EXPLAINED BY A CORRESPONDING EYE-READABLE MESSAGE ("TRANSFUSE MY BLOOD" OR "DO NOT TRANSFUSE MY BLOOD"). THE BARCODES THEMSELVES ARE DEFINED BY A SEPARATE SERIES OF UNIQUE CODES. AS PART OF THE DONATION PROCESS, ONE OF THE BARCODES IS SELECTED BY THE DONOR, REMOVED FROM THE SET, AND AFFIXED TO A DONOR REGISTRATION FORM. THE BARCODE IS SUBSEQUENTLY SCANNED AS PART OF STANDARD LAB PROCESSING. FOR COLLECTION DATE 2/21/96, AN UNUSUALLY HIGH NUMBER (29) OF "DO NOT TRANSFUSE MY BLOOD" RESPONSES, FROM TWO COLLECTION SITES, WERE SCANNED BY THE LAB. A REVIEW OF UNUSED LABEL SETS IN USE AT THESE SITES REVEALED THREE ADD'L SETS IN WHICH THE "TRANSFUSE MY BLOOD"/"DO NOT TRANSFUSE MY BLOOD" BARCODES WERE REVERSED. THE MFR WAS NOTIFIED IMMEDIATELY. ALL SELF-EXCLUSION BARCODE SETS WERE PLACED IN QUARANTINE AND SUBJECTED TO 100% VERIFICATION BY THE BLOOD CENTER AND/OR THE MFR. NO ADD'L BARCODE REVERSALS WERE FOUND IN ANY LABEL SETS. THE MFR'S EVALUATION REVEALED THAT THE ERROR WAS CAUSED BY A FAILURE TO FOLLOW STANDARD OPERATING PROCEDURES RESULTING IN UNAUTHORIZED MANUAL REPOSITIONING OF LABELS ON THE "WEB" DURING THE DIE-CUTTING PROCESS. CORRECITVE ACTION WAS IMPLEMENTED IMMEDIATELY.
NO SAMPLES WERE RETURNED BY THE USER FACILITY. THE MEDWATCH REPORT RECEIVED IN CONJUNCTION WITH THIS EVENT INDICATED THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. NO LOT NUMBER IDENTIFICATION WAS AVAILABLE TO SUPPORT ANALYSIS OF SISTER SAMPLES. THE USER FACILITY REPORTED THE DEVICE WAS IN USE WITH AN INTERMITTENT INJECTION CAP AND THAT THERE WAS A SMALL LENGTH OF CATHETER TUBE REMAINING ATTACHED TO THE CATHETER HUB. THE MFR'S EXPERIENCE HAS SHOWN THAT, WHEN CATHETER TUBING REMAINS ATTACHED TO THE HUB AFTER SEVERANCE, AN EXTERNAL CUTTING, PUNCTURING OR COMPRESSIVE FORCE HAS BEEN EXERTED AGAINST THE CATHETER TUBE CAUSING IT TO SEVER. SEVERANCE CAN OCCUR WITH ANY INTRAVENOUS CATHETER TUBE WHEN IMPROPER PROCEDURES ARE EMPLOYED DURING THE USE OF THE DEVICE. DEVICE INSTRUCTIONS ACCOMPANYING THE PRODUCT CAUTION AGAINST THE USE OF SCISSORS DURING DRESSING CHANGES, THE USE OF NEEDLES LONGER THAN ONE INCH WITH THE DEVICE AND REINSERTION OR REDIRECTION OF THE INTRODUCER NEEDLE DURING INSERTION. FREQUENCY OF OCCURRENCE IS NOT GREATER THAN USUAL FOR THIS DEVICE IN THAT THE INCIDENT RATE EVALUATED OVER THE PREVIOUS 12 MONTHS USING REGRESSION ANALYSIS DEMONSTRATES A STATISTICALLY SIGNIFICANT (P VALUE = 0.009) DOWNWARD SLOPE THAT IS SUBSTANTIAL (T-RATIO = -3.21). SEVERITY OF OCCURRENCE IS NOT GREATER THAN USUAL FOR THIS DEVICE IN THAT THE OUTCOME HAS BEEN LIMITED TO NO IMPACT (NO CATHETER EMBOLUS) TO CATHETER EMBOLUS REQUIRING DIAGNOSTIC STUDIES TO DETERMINE LOCATION WITH SUBSEQUENT MINOR SURGICAL CUTDOWN FOR RETRIEVAL. THE FDA ACCESS NUMBER FOR THE REPORT FILED CORRESPONDING TO THIS MATTER IS M742287.
EIGHT EVENTS REPORTED SINCE 11/95 OF MINOR RED MARKS NOTED UNDER PULSE OXIMETER PROBES. OPINIONS VARY AS TO WHETHER THESE ARE BURNS OR PRESSURE. IN ONE CASE SLIGHT SKIN BREAKDOWN WAS REPORTED. NO BLISTERS REPORTED. SIMILAR SMDA PREVIOUSLY FILED ON ANOTHER MFR'S NON-DISPOSABLE PULSE OXIMETER PROBE FOR SIMILAR INCIDENTS.
TEN EVENTS REPORTED SINCE 12/95 OF NEEDLELESS T-CONNECTORS "POPPING OUT" OF CATHETER HUBS. IN DISCUSSIONS WITH NURSING STAFF THE ACTUAL INCIDENCE IS HIGHER THAN DOCUMENTED. GENERALLY, DISCONNECTION OCCURS WHEN IV IS INITIALLY BEING PLACED; HOWEVER, IN SEVERAL INSTANCES, AN EXISTING LINE WAS FOUND DISCONNECTED. THREE CASES HAD "SIGNIFICANT BLOOD LOSS" RESULTING IN A TRANSFUSION IN A PREEMIE. TWO CASES OF PERIPHERAL ARTERIAL LINES, LOST DURING EFFORTS TO ACHIEVE ADEQUATE CONNECTION. NO ONGOING PT COMPROMISE HAS BEEN ATTRIBUTED TO THOSE EVENTS.
DURING COLLECTION OF SPECIMEN (OBTAINED THROUGH THE NOSE FOR A NASO-PHARNYX SPECIMEN) CHILD'S ARM BECAME LOOSE, THE SPECIMEN SWAB WAS HIT AND THE END BROKE OFF. RPTR'S CONCERN IS THAT TIP (IN PT NOT READILY SEEN, THOUGHT TIP REMAINED IN PT) COULD HAVE TRAVELED INTO AIRWAY OR ESOPHAGUS. CHILD SENT TO X-RAY TO DETERMINE INTERNAL POSITION. TIP NOT IN PT. IT WAS FOUND ON FLOOR IN PT AREA.
ONE HUNDRED AND TWENTY-FIVE (125) MG OF CARDIZEM WAS ADDED TO 100CC 1/2 NS AND HUNG AT 12:20 PM ON 2/11/96 TO INFUSE AT 5CC/HR, VIA INFUSION PUMP ON SECONDARY. PRIMARY WAS SET ON 80CC/HR BUT WAS TURNED OFF. ONE HOUR LATER, NURSE CHECKED INFUSION AND IT APPEARED TO BE WORKING PROPERLY. THERE WAS LITTLE FLUID INFUSED. HOWEVER, AT 3:00 PM, THE SECONDARY IV BAG WAS EMPTY AND THE PRIMARY IV WAS INFUSING. THE INFUSION PUMP SHOWED 98CC LEFT TO INFUSE FROM THE SECONDARY IV. THE NURSE STATES THE ALARM HAD SOUNDED DURING THE INFUSION, BUT DOES NOT RECALL WHICH ALARM WAS GOING OFF. SHE ASSUMED SINCE THE RATE WAS SO SLOW, THE ALARM WAS FOR "OCCLUSION." THE NURSE RESET THE SECONDARY FLOW RATE. THE NURSE IS NOT AWARE OF ANY OTHER NURSE ADDRESSING THE ALARM SYSTEM OF THIS PUMP. THERE WAS NO CHANGE IN THE PT'S VITAL SIGNS AFTER THIS INCIDENT. INFUSION PUMP WAS INSPECTED BY THE BIO-MED ENGINEER. HE COULD NOT DUPLICATE THE INCIDENT. NO MALFUNCTION WAS DETECTED.
CAREGIVER PREPARING IV SOLUTION TUBING BEFORE CONNECTING TO PT AND INSERTING CASSETTE INTO PUMP. WHEN TUBING NEAR FILTER WAS TAPPED TO REMOVE AIR, IT CAME APART BELOW THE FILTER.
THE CAP ON THE ARTERIAL LINE THAT HOOKS TO THE TRANSDUCER WOULDN'T COME OFF. IT WAS SCREWED ON TOO TIGHT.
PT EXHIBITED PROFOUND HYPOTENSION VIA ARTERIAL ALARM. UPON INVESTIGATION 8.5 FR INTRODUCER IN LEFT FEMORAL VEIN FOUND DISCONNECTED FROM SIDE PORT/HEMOSTASIS VALVE CATHETER. PT LOST A SIGNIFICANT AMOUNT OF BLOOD; REQUIRED 8 UNITS OF PACKED RED BLOOD CELLS. FLUID RESUSCITATION ACCOMPLISHED WITHIN THREE MINS.
SIX FRENCH VASCULAR SHEATH PLACED WITHOUT DIFFICULTY. A (5 FR PIGTAIL) FLUSH AORTOGRAM AND (5.5 FR H #1) TWO SELECTIVE BRACHIOCEPHALIC INJECTIONS WERE PERFORMED THROUGH THE SHEATH WITHOUT PROBLEM. WHEN TRYING TO PERFORM THIRD SELECTIVE WITH A 5.5 FR CATHETER THE CATHETER OR WIRE WOULD NOT PASS THROUGH THE HEMOSTATIC DIAPHRAGM. THE STUDY WAS TERMINATED AND THE SHEATH REMOVED AND EXAMINED. IT APPEARS THE HEMOSTATIC APPARATUS AND SEALING RING WERE TURNED SIDEWAYS IN THE SHEATH. NO ADVERSE CONSEQUENCES TO PT.
IN 1/90 RPTR HAD RIGHT BREAST RECONSTRUCTIVE SURGERY WITH EXPANDER IMPLANTED. (7/80 RPTR HAD CANCER RIGHT BREAST. MODIFIED RADICAL MASTECTOMY PERFORMED.) IN 7/90 RPTR HAS BURNING JOINT PAIN IN KNEES. HER HEALTH BEGAN TO DETERIORATE FROM THERE TO ADD'L JOINT PAIN IN ANKLES AND WRISTS, MUSCLE PAIN, NEUROPATHY, PAIN, FATIGUE, DEPRESSION, RASHES, NIGHT SWEATS, BALANCE AND CONCENTRATION PROBLEMS AND CHEST PAIN. THE RIGHT BREAST IMPLANT RUPTURED AND RPTR HAD A CAPSULAR CONTRACTURE.
RPTR STATES "CONTROVERSAL EFFECTS OF SILICONE IMPLANTS."
BAXTER HEALTHCARE CORP. RT 120 & WILSON RD, ROUND LAKE IL 60073-0490. ADD'L INFO: THE REPORT FROM THE CUSTOMER INDICATED THAT THE SEPARATION OF THE SLEEVE STOPPER FROM THE INJECTION SITE OCCURRED WHEN AN AUTOINJECTOR WAS BEING USED TO INJECT CONTRAST MEDIA THROUGH THE INJECTION SITE. THE LABELING FOR THE INJECTION SITE HAS THE CAUTION STATEMENT "DO NOT APPLY EXCESSIVE INTERNAL PRESSURE." IT IS KNOWN THE AUTOINJECTORS CAN EXERT PRESSURES WELL IN EXCESS OF 100 PSI. THIS EXESSIVE PRESSURE WAS THE LIKELY CAUSE OF THE SEPARATION OF THE INJECTION SITE.
PT OPENED 10-UNIT BAG OF SYRINGES AND WAS STUCK BY NEEDLE THAT HAD NO CAP. THE BAG HAD BEEN SEALED PRIOR TO OPENING. THERE WAS NO LOOSE CAP IN THE BAG. THE OTHER SYRINGES HAD CAPS ON THEM. PT IS LONGTIME DIABETIC WITH GOOD PRODUCT KNOWLEDGE AND SAFE-HANDLING PROCEDURES.
NEW YELLOW BOVIE PENCIL FIRED SPONTANEOUSLY AND WOULDN'T SHUT OFF UNTIL UNPLUGGED. PENCIL ALSO PLUGGED IN, BUT DIDN'T MALFUNCTION.
IV TUBING BECAME DISCONNECTED AT CASSETTE. THE PT'S BLOOD BACKED UP INTO THE TUBING.
UPON OR NURSE'S AIDE (NA) CONTACT WITH MFR'S STERILANT CONTAINER FOR PLACEMENT IN MFR'S STERILANT MACHINE, CONTAINER SPONTANEOUSLY OPENED, RESULTING IN SPILLAGE OF SOLUTION ONTO NA AND SPREAD OF FUMES. NA EVALUATED IN ER AND ADMITTED TO HOSP OVERNIGHT.
CATHETER WAS TESTED PRIOR TO INSERTION. UPON ATTEMPTING TO FLOAT THE CATHETER (ON INSERTION) THE BALLOON INFLATED AND DEFLATED ONCE. THE SECOND TIME THE BALLOON INFLATED, IT WOULD NOT DEFLATE. UPON INABILITY TO OBTAIN APPROPRIATE PLACEMENT, THE CATHETER WAS WITHDRAWN AND REMOVED. THE BALLOON APPEARED TO HAVE RUPTURED AND WAS NOT PRESENT ON THE END OF THE CATHETER.
OPERATION: LAPAROSCOPIC CHOLECYSTECTOMY, EXPLORATORY LAPAROTOMY. COMPLICATIONS: THE PT BECAME BRADYCARDIC, HYPOXIC AND HYPOCARBIC FOR APPROX 5 MINS. THE GALLBLADDER WAS REMOVED FROM THE BED, IT WAS BROUGHT OUT THROUGH THE LEFT UPPER QUADRANT AND SAC. THE GALLBLADDER BED WAS THEN VISUALIZED. THERE WAS SOME OOZING FROM THE GALLBLADDER FOSSA. SUBSEQUENTLY THE A.B.C. (ARGON BEAM COAGULATOR) WAS BROUGHT INTO THE FIELD. THE LIVER WAS COAGULATED. THE PRESSURE ON THE ABDOMEN WAS NOTED TO REACH 35 MMHG. THIS WAS DECOMPRESSED WITHIN 20 - 30 SECS. APPROX ONE MIN FOLLOWING THIS, THE PT'S HEART RATE WAS NOTED TO GRADUALLY DROP TO THE 30'S AND A SINUS BRADYCARDIA. THE PT'S PCO2 WAS NOTED TO GO INTO SINGLE DIGITS. THE PT'S PULSE OX DROPPED QUICKLY AND THEN RETURNED TO THE HIGH 90'S AND THEN DROPPED REPEATEDLY. THE FEELING WAS THAT THE PT WAS HAVING SOME EMBOLIC EVENT. SUBSEQUENTLY THE PT WAS PLACED IN THE TRENDELENBURG POSITION WITH THE LEFT SIDE DOWN. WITHIN SEVERAL MINS, THE PT'S PRESSURE, O2 SAT AND CO2 RETURNED TO NORMAL.
PACEMAKER HEADER SEEMED TO BE MALFUNCTIONING. LEAD CAME LOOSE.
ON 2/24/96, PT HAD BEEN UP AND ABOUT IN ROOM. WHEN HE WENT INTO THE SHOWER, THE CATHETER FELL OUT. APPARENTLY THE PT HAD TOLD DR THAT IT WAS LOOSE AND NEEDED A COUPLE OF STITCHES. A PERIPHERAL LINE WAS STARTED. AT THE TIME THE CATHETER FELL OUT, AN IV OF 1000CC D5/1/2NS WITH 20 MEQ KCL, 8 MGSO4 WAS RUNNING.
A 68-YR-OLD MALE ADMITTED ON 3/5/96 WITH LARYNGEAL STENOSIS SECONDARY TO LARYNGECTOMY 13 YEARS AGO FOR LARYNGEAL CANCER. ON 3/20/96, PT UNDERWENT PLACEMENT OF A SINGLE LUMEN CENTRAL LINE CATHETER. DURING PLACEMENT, THE CATHETER SEPARATED IN TWO, 1 1/2 CM DISTAL TO THE CUFF. THERE WAS NO EVIDENCE, AS STATED BY THE PHYSICIAN THAT PLACED THE LINE, THAT THE CATHETER WAS CUT. THE PT WAS TAKEN TO RADIOLOGY AND CATHETER PIECE RETRIEVED FROM RIGHT PULMONARY ARTERY. THE PT SUFFERED NO SEQUELAE AS A RESULT OF THIS EVENT.
PHYSICIAN ATTEMPTED TO REMOVE DRAIN, DRAIN TUBING BROKE AT EXIT SITE. PT WAS RETURNED TO SURGERY TO RETRIEVE REMAINING TUBING IN THE ABDOMEN.
POST LAPAROSCOPIC CHOLECYSTECTOMY OF 2/28/96. RETURNED ON 3/4/96 WITH INCREASING ABDOMINAL PAIN FOR 72 HRS. UNDERWENT DIAGNOSTIC LAPAROSOCPY AND REPAIR OF EXTRA HEPATIC BILIARY DUCT ON 3/4/96. OPERATIVE FINDINGS INCLUDED FISSURING OF THE PROXIMAL-MOST HEMOCLIP AND A BILE LEAK AT THE CYSTIC DUCT.
PT SCHEDULED FOR REMOVAL AND REPLACEMENT OF SILICONE BREAST PROSTHESIS. ON INITIAL INSPECTION, BOTH RIGHT AND LEFT IMPLANTS WERE RUPTURED.
COMPLAIN OF PAIN WITH REMOVAL OF LEFT HIP HARDWARE.
RUPTURED RIGHT BREAST GEL IMPLANT. GEL IMPLANT WAS PLACED AROUND 1978-80 AT A MILITARY HOSP.
PT EXPERIENCING SYNCOPE, MIDSTERNAL PAIN. OVERSENSING PACEMAKER LEAD AND GENERATOR. MILD AORTIC INSUFFICIENCY. INAPPROPRIATE FIRING.
VENTILATOR FAILED ON TWO OCCASIONS. THE FIRST ON 2/1/96, THE LOW VOLUME ALARM KEPT SOUNDING AND COULD NOT BE CORRECTED. THE SECOND EVENT OCCURRED ON 2/29/96. THE LOW VOLUME ALARM KEPT SOUNDING AND COULD NOT BE CORRECTED. SINCE 2/13/95 HOSP HAS FILED FOUR (4) REPORTS ON THIS SAME PIECE OF EQUIPMENT. ONE PT FEMALE, ONE MALE, ADD'L AGE 70.
PT SUFFERED A SUPRACONDYLAR FRACTURE OF THE RIGHT FEMUR WITH INTERNAL FIXATION IN 9/95. SHE WAS READMITTED ON 2/1/96 FOR REVISION OF HARDWARE. AFTER THE INITIAL SURGERY, THE PT DID WELL, BUT FAILED TO HEAL THE FRACTURE AND EVENTUALLY THE ROD BROKE FROM FATIGUE THROUGH ONE OF THE SCREW HOLES JUST DISTAL TO THE FRACTURE SITE.
PORT INSERTED 8/5/95 AND USED FOR CHEMOTHERAPY TREATMENT. PT NOTED "AWARENESS" IN SHOULDER. ONCOLOGIST ORDERED CHEST X-RAY WHICH SHOWED THAT PORT HAD FRACTURED WITH DISTAL END MIGRATING TO RIGHT VENTRICLE.
RESIDENT DISCOVERED IN BED PRONE WITH HEAD THROUGH OPENING IN SIDE RAIL. BRUISES OBSERVED ON NECK, FACE AND SHOULDER. MEDICAL EXAMINER REMOVED BODY; RESULTS OF ANY TESTS ARE UNKNOWN.
PUMP WAS PROGRAMMED TO INFUSE Q 6 HR, FIRST 2 DOSES INFUSED OK, BUT 3RD DOSE DIDN'T START UNTIL 9 HRS AFTER 2ND DOSE. PT DENIES HEARING ANY ALARMS. HE NOTICED BLOOD BACK-UP THROUGH HIS PICC UP TO THE IN-LINE FILTER. KVO RATE OF 0.4 ML/HR WAS ALSO PROGRAMMED IN. PROGRAM WAS CHECKED BY RPH AND 2 CRNI'S BEFORE PT HOOK-UP. DELAY START WAS SET FOR 06:00 PM AND PUMP DID INFUSE 1ST DOSE AT THAT TIME. ALTHOUGH WHEN TROUBLE-SHOOTING BLOOD BACK-UP AND PUMP WAS INFUSING 3RD DOSE (3 HRS LATE), THE DELAY START READ 3:00 PM. BOTH PT AND WIFE DENY CHANGING PUMP OR PUSH BUTTONS AND PT IS HALF BLIND.
THIS PT OFFERED NO COMPLAINTS , RE-TREATMENT. TREATMENT STARTED AT 645 AM. AT 905 SHE C/O ABDOMINAL CRAMPS. BP WAS 88/60, WAS GIVEN 400CC NS. AT 945, PT AGAIN C/O ABDOMINAL PAIN. NS GIVEN. DR NOTIFIED. PT OFFERED TO HAVE TREATMENT DISCONTINUED AT 1020 AM. CONTINUED TO C/O ABDOMINAL PAIN. DR CALLED, PT WAS TAKEN TO ER AND ADMITTED FOR ANALYSIS. NO KINKS WERE NOTED IN LINES. THE MACHINE WAS PULLED AND CHECKED. THE BLOOD PUMP WAS FOUND TO BE MALOCCLUDED. NO OTHER PROBLEMS WERE FOUND WITH THE MACHINE. THE PT IS BACK TO THE CENTER FOR HER TREATMENTS.
PT WAS FOUND UNRESPONSIVE IN BED BY STAFF. STAFF STATES THE APNEA MONITOR WAS TURNED ON, BUT NO AUDIBLE ALARM WAS HEARD. PT ELECTRODES WERE NOT ON PT, BUT STUCK TO THE PT'S BEDDING. MONITOR WAS TURNED OFF AND CPR WAS STARTED. CPR WAS ALMOST IMMEDIATELY STOPPED DUE TO THE PT'S "NO CODE" STATUS.
PHYSICIAN STATES IN DISCHARGE SUMMARY THERE WAS A PROBLEM WITH THE IV PUMP ADMINISTERING THE INOTROPIC AGENTS ON THE WAY FROM SURGERY TO ICU. THE PUMP DID FAIL IN ICU AND WAS CHANGED OUT IMMEDIATELY.
PT BECAME HYPOTENSIVE AFER FLEX SIGMOIDOSCOPY, ABDOMEN FIRMER. FLAT PLATE OF ABDOMEN DONE WHICH SHOWED MASSIVE FREE AIR-PROBABLE PERFORATION. PHYSICIAN DISCUSSED OPTION OF REPAIR OF PERFORATION WITH FAMILY. DECISION WAS MADE TO MAKE PT A "NO CODE"; SURGICAL REPAIR WAS NOT PURSUED. PT WAS ON A VENTILATOR AND EXPIRED THREE DAYS LATER.
TRIPLE LUMEN CENTRAL LINE CATHETER INSERTED ON 11/29/94 FOR PARENTERAL NUTRITION. IN THE EAERLY MORNING OF 12/10/94, THE PT ARRESTED AND WAS PRONOUNCED DEAD AT 0308. (*)
DURING THORACENTESIS PROCEDURE, CATHETER BROKE LOOSE, X-RAYS SHOWS PARTIAL CATHETER FREE FLOWING IN PLEURAL SPACE. SURGEON AND RADIOLOGIST CONSULTED. FAMILY NOTIFIED BY INTERNIST AND SURGEON, DECISION WAS MADE NOT TO DO SURGERY.
WHILE ATTEMPTING TO TRANSFER RESIDENT FROM CHAIR TO BED VIA LIFT, THE SWIVEL BAR AND CASTLE NUT GAVE WAY AND THE RESIDENT FELL TO THE FLOOR. UPON INSPECTION OF THE SWIVEL BAR, HOOK AND CASTLE NUT ASSEMBLY IT WAS IMMEDIATELY EVIDENT THAT THERE WAS WEAR AT THE BASE OF THE SWIVEL ARM AND THE CASTLE NUT.
PERSISTANT SEVERE PAIN AND SWELLING RIGHT KNEE. KNEE ASPIRATIONS SHOWED NO GROWTH. PRESUMED INFECTION WAS FELT TO BE PRESENT. HARDWARE REMOVED. ANTIBIOTIC IMPLANTED.
PT ADMITTED FOR TOTAL ARTHROPLASTY OF KNEE RE-DO. SECOND DEGREE FRACTURE OF PREVIOUS IMPLANT BASE PLATE.
PT REQUESTED REMOVAL OF BREAST PROSTHESIS FOR PREVENTIVE REASONS.
UNDERWENT EXPLANTATION OF RUPTURED LEFT BREAST IMPLANT.
UNDERWENT SURGERY FOR REMOVAL OF BREAST IMPLANTS; HAD BILATERAL CAPSULAR CONTRACTIONS AND LEFT IMPLANT WAS RUPTURED.
UNDERWENT SURGICAL EXPLANTATION OF BREAST IMPLANTS; BOTH WERE RUPTURED.
UNDERWENT EXPLANTATION OF RIGHT BREAST PROSTHESIS AND RIGHT MODIFIED RADIAL MASTECTOMY FOR ADENOCARCINOMA.
BALLOON WOULD NOT INFLATE IN CORONARY ARTERY. STENT NOT DEPLOYED. CATHETER REMOVED AND ANOTHER WAS USED. NO HARM DONE TO PT.
A WHITE PIECE OF PLASTIC WAS FOUND FLOATING IN THE TUBING NEAR THE CASSETTE.
WHILE DOING A DIFFICULT ERCP, THE BILIARY WALL STENT WAS IN PLACE AND THE RN ATTEMPTED TO DEPLOY THE STENT UNDER THE DIRECTION OF THE CO REP. THE STENT SNAPPED AND BROKE.
DEVICES PLACED IN 8/95 FOR THE ADMINISTRATION OF CHEMOTHERAPY. DURING THE EIGHTH TREATMENT, PROBLEMS WITH PORT WERE NOTICED. RADIOLOGY SHOWED FRAGMENTATION OF THE 2ND DEVICE. DUE TO THE POSSIBILITY OF CARDIAC SURGERY AS INTERVENTION, PT WAS TRANSFERED TO ANOTHER MEDICAL CENTER. FLUOROSCOPY REVEALED A FOUR TO FOUR AND ONE HALF INCH FRAGMENT LODGED IN RIGHT ATRIUM. EMBOLIZED PORTION OF CATHETER WAS RETRIEVED TRANSVENOUSLY IN THE CATH LAB. 1 ST DEVICE REMOVED SURGICALLY IN THE OR.
PT TO HOSP WITH BILATERAL BREAST PAIN, DISTORTION AND SYMPTOMATIC CONTRACTURES DUE TO IMPLANTS. LEFT BREAST = 285 GM, 9.2 X 7.6 X 5.2 CM. RIGHT BREAST = 182 GM, 9.3 X 7.8 X 5 CM. NO DISCERNIBLE MARKINGS ON EITHER BREAST.
BOVIE HANDPIECE BEGAN TO SMOKE. BOVIE PAD PLACEMENT CHECKED - GOOD PT CONTACT. BOVIE PAD WAS REPLACED.
FACILITY REPORTED THAT BLOOD TUBING HAD A LEAK ON THE ARTERIAL LINE AT THE TOP NEAR THE CHAMBER. PT LOST APPROX 200CC OF BLOOD. PT DID NOT NEED ANY TREATMENT. TREATMENT DISCONTINUED - UNABLE TO RETURN BLOOD.
FACILITY REPORTED THAT THE BLOOD TUBING HAD A LEAK ON THE ARTERIAL LINE AT THE TOP NEAR THE CHAMBER. PT LOST APPROX 400-500 CC OF BLOOD. PT'S REACTION WAS SHORTNESS OF BREATH. HE RECEIVED OXYGEN AND STAT CBC.
12/95 THE 1/2" DRAIN WAS PLACED IN THE PT'S PELVIS FOLLOWING SURGERY. TRS/HEMICOLECTOMY. SUBTOTAL HYSTERECTOMY. PER NURSES NOTE THE DRAIN WAS FOUND TO BE OUT 12/20/95 AND DRAIN DC'D. FRAGMENT NOTED IN RIGHT LQ ON CT SCAN. PT IN RENAL FAILURE, SECONDARY TO PROGRESSIVE CA. ON 4/4, ELECTED TO REMOVE DRAIN USING ASEPTIC TECHNIQUE AND LOCAL ANESTHESIA WITH INTERMITTENT FINE PRESSURE OVER 20 MINS. THE DRAIN FRAGMENT WAS REMOVED INTACT. SPECIMEN WAS LABELED AND SENT TO PATHOLOGY.
PUMP DID NOT DELIVER DOSE OF CEFAZOLIN VIA PICC LINE. LONG TERM CARE FACILITY RN REPORTED SUFFICIENTLY WARMING OF THE DOSE TO ROOM TEMP PRIOR TO INFUSION. SOLUTION: CEFAZOLIN 1 GM IN D5W. 50 ML TOTAL VOLUME.
SKIN UNDER ADHESIVE PORTION OF ESU PAD ABRADED. NO BURN NOTED.
WHEN REMOVING PAD FROM PT, ADHESIVE PORTION REMOVED "TANNED SKIN ALL AROUND DISPERSIVE PORTION."
STENT DISLODGED, REQUIRING RETRIEVAL WHICH WAS SUCCESSFUL. RPTR TRIED TO PASS STENT CATHETER INTO VESSEL AND PRE-DILATED LAD, BUT COULD NOT GO FURTHER. A SHADOW WAS SEEN FOLLOWING THIRD ATTEMPT. IT WAS THE STENT OF THE CATHETER FLOATING UNDEPLOYED IN LEFT MAIN. PT STABLE THROUGHOUT.
SEPTRA 20CC VIAL SENT OUT ATTACHED TO TO 500CC D5W BAG VIA BINARY CONNECTOR. PT AND RN TRIED TO FORCE PLUG OUT IN ORDER TO TRANSFER DRUG INTO SOLUTION. PLUG WOULD NOT COME OUT. DRUG WOULD NOT BE MIXED INTO SOLUTION.
FOLEY CATHETER FOUND IN BED 12/5/95 CUT WITH TIP MISSING. EDGES CLEAN. UNABLE TO DETERMINE IF PT CUT TUBING OR IF IT SOMEHOW BROKE APART. 12/6/95 PT PASSED TIP OF CATHETER DURING BOWEL MOVEMENT. WITNESSED RN. (*)
SUTURE NEEDLE TIP BROKE OFF OF THE NEEDLE DURING FIRST PASS BY DR. DEVICE TO BE RETURNED TO MFR FOR EVALUATION.
THE INNER SEAL WHICH CONNECTS THE DISPOSABLE TROCAR SHEATH, SNAPPED OFF. COULD NOT FIT THE REDUCER IN PLACE. DR CONTINUED THE PROCEDURE WITH ANOTHER UNIT. DEVICE TO BE RETURNED TO MFR FOR EVALUATION.
DISPOSABLE STAPLER MISFIRED SEVERAL TIMES DURING AN ATTEMPTED REPAIR OF A RIGHT FLANK HERNIA. DEVICE TO BE RETURNED TO MFR FOR EVALUATION.
ADMITTED FOR D & C, LAPOROSCOPY AND LAPOROTOMY. BOWEL WAS PERFORATED. PERFORATION CLOSED BY SURGEON. REQUIRED OVERNIGHT HOSPITALIZATION. ADMITTING SURGEON STATED THE TROCAR WAS TOO SHARP. AFTER THE SURGERY WAS COMPLETED AND ROOM CLEARED OF TRASH, THE SURGEON STATED THE STAPLER WAS FAULTY. IT WAS NOT RETRIEVED OR SAVED.
FRACTURE OF RIGHT CONDYLAR NECK OF PROSTHESIS PREVIOUSLY IMPLANTED FOR TMJ. PT WAS HAVING SEVERE PAIN AND WAS NOT ABLE TO OPEN MOUTH. REQUIRED HOSPITALIZAITON AND SURGERY.
PATCH IMPLANTED ON 8/1/94. PT INDICATED PATCH (SUTURE) CAME LOOSE AROUND MIDNIGHT. THE BOWEL EVISCERATED AROUND THE PATCH AT THE SUTURE AND CAME UP THROUGH ONE SIDE OF THE INCISION PUSHING GRAFT TO ONE SIDE. PT WAS TAKEN BACK TO SURGERY TO REPLACE PATCH.
THE INTRAVENOUS BAGS HAVE BEEN DELAMINATING THUS CAUSING A "BLISTERING" OF THE TWO LAYERS OF EVA USED IN THE MFG PROCESS. ALSO FACILITY HAS DISCOVERED SMALL BLACK AND BROWN SPOTS IN THE CLER EVA SURFACE. FACILITY HAS BEEN TOLD THAT THESE SPOTS ARE CAUSED FROM CARBON RESIDUE DURING THE MFG PROCESS. THE MFR STATES THAT BLISTERING DOES NOT COMPROMISE THE BAG INTEGRITY OR STERILITY. THE SAME IS ALSO SAID TO BE TRUE REGARDING THE SPOTS. FACILITY HAS FOUND THIS PROBLEM TO BE CONSISTENT WITH THE 1000ML, 200ML AND 3000ML BAGS THEY HAVE USED. FACILITY HAS HAD NO INJURIES OCCUR WITH THESE BAGS BUT FEELS THERE MAY BE SOME POTENTIAL FOR ADVERSITY. THESE PROBLEMS THUS FAR HAVE BEEN ONLY COSMETIC. FACILITY HAS ALERTED THE MFR AND THEY WILL BE CONTACTING FACILITY WITH THEIR PROPOSED SOLUTION.
IMPLANT REMOVED DUE TO BREAST PTOSIS AND MAMMARY IMPLANT WRINKLING AND TO REPLACE WITH IMPLANT TO MATCH OTHER SIDE.
PT ON STIMULATOR RECEIVED BURNS TO BODY.
IV INFUSION PUMPS BROUGHT INTO SVC 2/14/95. SINCE THAT TIME THERE HAVE BEEN MULTIPLE INCIDENTS WHICH INCLUDE: AIR LOCKS FORMING IN THE PRIMED TUBING, SHEARING OF THE TUBING AT CONNECTOR SITES, AND CRACKING OF THE PUMP CASSETTES WHILE IN OPERATION.
BREAST IMPLANT REMOVED. LEFT IMPLANT WAS RUPTURED PRIOR TO REMOVAL. BREAST IMPLANTS REPLACED BILATERALLY. CAPSULE SENT TO PATHOLOGY FOR REVIEW. IMPLANTS TO BE SENT TO CO BY PHYSICIAN.
COMPOUNDER WAS PROGRAMMED TO PREPARE A TPN SOLUTION WITH POTASSIUM (K+) 1MEQ/100ML. DUE TO A MALFUNCTION OF THE PUMP, THE TPN SOLUTION CONTAINED 12.56MEQ K+ PER 100ML. THE PT'S SERUM K+ INCREASED FROM 4.4 ON 12/7/93 TO 7.9 ON 12/8/93. THE IV WAS DISCONTINUED PRIOR TO ANY DETRIMENTAL CONSEQUENCES TO THE PT. PT'S WEIGHT 0.96 KG.
PT WITH CORONARY ARTERY DISEASE HAD CORONARY ARTERY BYPASS GRAFT SURGERY ON 8/21/95. THE PERFUSIONIST REPORTED THAT THE CELL SAVER TOOK AN INORDINATELY LONG TIME TO DECELERATE FROM 5600 RPM. HE ALSO REPORTED THAT THE DETECTOR FAILED TO NOTE WHEN THE CELL SAVER BOWL WAS EITHER FULL OR EMPTY. BIOMED REPLACED THE DETECTOR LIGHT, BUT THE DECELERATION PROBLEM REMAINS AS A PRODUCT QUALITY PROBLEM.
DURING (RIGHT EYE) CATARACT PHACOEMULSIFICATION WITH LENS IMPLANTATION AND WHILE LOWERING THE MICROSCOPE INTO POSITION BY THE SURGEON, THE SCOPE CAME LOOSE AND STARTED TO FALL ONTO PT. THE CIRCULATING OR NURSE GRABBED UNDER AND HELD THE SCOPE. PHYSICIAN AND NURSE PUT SCOPE BACK INTO POSITION AND REATTACHED IT. CO TECH FOUND THAT THE SECURITY SCREW COULD HAVE WORKED ITS WAY OUT DUE TO BREAKDOWN IN LUBRICATION.
PT WITH DIAGNOSIS OF HEMATURIA HAD CYSTOSCOPY. LATER, AN ATTEMPTED BILATERAL RETROGRADE PYELOGRM WAS ABORTED DUE TO EQUIPMENT FAILURE. SURGICAL TECH STATED THAT FLUORISCOPY EQUIPMENT WAS OPERABLE PRIOR TO PROCEDURE. AFTER PT WAS PLACED ON TABLE IN LITHOTOMY POSITION, AS PROCEDURE BEGAN TO PROGRESS, THERE WAS A FAILURE OF FLUORO. PORTABLE X-RAYS ATTEMPTED BUT COULD NOT POSITION OVER PT BECAUSE OF THE TABLE STRUCTURE.
PT WITH STAB WOUNDS TO RIGHT CHEST AND LIVER WAS SEEN IN ER. IV FLUIDS THAT WERE WARMED IN THE INCUBATOR UNIT WERE STARTED IN LEFT ARM IV. PT COMPLAINED OF BURNING, AND THE IV WAS SHUT OFF. PT LATER DEVELOPED REDNESS AT THE IV SITE AND BLISTERS UP THE LEFT ARM. BIOMED CHECKED THE INCUBATOR AND FOUND IT WORKING PROPERLY AND TEMP TESTS MET MFR'S RECOMMENDATIONS. PT WAS TREATED FOR CELLULITIS AT THE IV SITE AND DISCHARGED TO HOME.
INSULIN-DEPENDENT DIABETIC PT WITH ONLY ONE LEG (LEFT LEG WAS AMPUTATED) WAS UNDERGOING AN X-RAY INTRAVENOUS PYELOGROM FOR S/S OF MICROHEMATURIA. DURING THE PROCEDURES, THE RADIOLOGY TECHNICIAN NOTED THAT SMOKE WAS COMING FROM THE X-RAY TABLE. THE PT WAS SAFELY REMOVED FROM THE TABLE, NO HARM TO PT. THE FIRE/SMOKE EMERGENCY SYSTEM WAS ACTIVATED AND THE POWER SUPPLY SHUT DOWN. THE BIOMED DEPT REPLACED THE ELECTRONIC MAGNET THAT HAD SHORTED AND ALSO REBUILT THE POWER SUPPLY THAT HAD CAUGHT FIRE.
FISTULA NEEDLE FOR VENOUS BLOOD RETURN ON DIALYSIS PT PULLED OUT OF GRAFT WITH APPROX BLOOD LOSS 700-900ML. DIALYSIS MACHINE VENOUS PRESSURE ALARMS WERE AUTOMATICALLY SET FOR PLUS OR MINUS 50MMHG. VENOUS PRESSURE IN GRAFT WAS 100MMHG. VENOUS PRESSURE ALARMS DID NOT ACTIVATE. AIR DETECTOR ALARM ACTIVATED TO STOP BLOOD PUMP. NURSE THEN FOUND MISPLACED NEEDLE AND BLOOD LOSS. PT TRANSFERRED TO ACUTE HOSP FOR TRANSFUSION OF 2 UNITS BLOOD. MACHINE TAKEN OUT OF SVC 10/19/95 AM. MACHINE PASSED ALL DIAG, SAFETY CHECKS INITIALLY. FURTHER CHECKS REVEALED MACHINE DID NOT CONSISTENTLY ALARM WHEN VENOUS PRESSURE DROPPED TO 10MMHG. DIAG AND SAFETY CHECKS REPEATED BY SVC REP ON 10/20/95. INITIALLY ALL SAFETY CHECKS PASSED, REPEATED TESTS CONFIRMED VENOUS PRESSURE ALARMS WERE AN ISSUE OF CONSISTENCY. PRESSURE CONT BOARD REPLACED 10/20/95.
PT PRESENTED WITH SINCOPE DUE TO THIRD DEGREE HEART BLOCK WITH HYPOTENSION. HE WAS PLACED ON EXTERNAL PACEMAKER SHORTLY AFTER ARRIVAL ON 12/29/94. SHORTLY AFTER MIDNIGHT, EN ROUTE TO CARDIOLOGIST, THE PACEMAKER QUIT WORKING ALTOGETHER REQUIRING PT'S RETURN TO THIS FACILITY AND ACTIVATION OF ANOTHER PACEMAKER. PT WAS BRADYCARDIC WHILE OFF PACEMAKER IN THIRD DEGREE BLOCK WITH HEART RATE 40. EXTERNAL PACEMAKER WOULD NOT WORK EVEN WHEN PLUGGED INTO 110 VOLT AMBULANCE ELECTRIC OUTLET.
WHEN THE VENTILATOR CYCLES, THE PRESSURE GAUGE WOULD NOT READ. INVESTIGATION FOUND A THIN COVER WAS ON THE ADAPTER GOING TO THE PRESSURE GAUGE. CIRCUIT WAS PULLED AND THE MFR WAS NOTIFIED. ALL CIRCUITS WITH THE SAME LOT # WERE PULLED. THE VENTILATOR WAS BEING USED FOR NEONATAL TRANSPORT. AGE AT TIME OF EVENT: FEW HOURS OLD.
RPTR WAS TRYING TO EXTRACT A BLOOD CULTURE BOTTLE FROM THE DEVICE WHEN THE BOTTLE BROKE CAUSING A LACERATION TO THE RIGHT THUMB. RPTR WENT TO THE ER FOR TREATMENT AND RECEIVED STITCHES AND A TETANUS SHOT.
PT ALLEGES A CONTACT LENS BROKE IN HER RIGHT EYE. SHE REMOVED IT IN 2 PIECES AND SHE CLAIMS IT CAUSED A CORNEAL ABRASION. SHE CAME IN TO BE EXAMINED APPROX 6 HRS AFTER THE ALLEGED EVENT AND WAS NOT IN PAIN.
RPTR DEVELOPED SILICONE IMPLANT SYNDROME (SIMS)  AKA ATYPICAL CONNECTIVE TISSUE DISEASE WITH ATYPICAL NEUROLOGICAL SYNDROME IN 1995. SHE C/O PERIPHERAL NEUROPATHY 1993, VERTIGO 1995, TINNITIS 1995, SLEEP DISORDER 1995 AND VISUAL DISTURBANCE 11991-96.
PT HAD BILATERAL BREAST IMPLANTS REMOVED. IMPLANTS WERE INTACT. PT REQUESTED LARGER IMPLANTS. 350CC GEL IMPLANTS REMOVED.
PT HAD BILATERAL CAPSULOTOMIES AND ASSYMETRICAL DEFORMITY.
PT HAD CONTRACTURE OF TISSUE EXPANDER OF RIGHT BREAST.
PT HAD VOLUME LOSS WITH CAPSULE FORMATION. RIGHT BREAST. IMPLANT INTACT.
ON 3/12/96 PT HAD GLUCOSE METER READING OF 195. PT EXHIBITING SYMPTOMS OF HYPOGLYCEMIA. SENT TO EMERGENCY DEPT. 10 MIN LATER, PT'S GLUCOSE WAS 63 ON A DIFFERENT METER. THIS CORRELATED WITH LAB RESULTS. DR TREATING PT SUGGESTED THERE MAY BE A PROBLEM WITH THE METER THAT GAVE THE HIGH READING.
RPTR'S WRITING ABOUT A VERY GRAVE ISSUE, PEDICLE PLATES AND SCREWS. HE HAS THEM IN HIS BACK. HE SUFFERED WITH THIS SUPPOSEDLY LATEST STATE OF MEDICAL SCIENCE SINCE THEY WERE PUT IN. HE NEEDS THEM TAKEN OUT. BECAUSE OF HIS CIRCUMSTANCE WITH HIS INSURANCE CO HE HAS BEEN UNABLE TO HAVE ADD'L MEDICAL CARE. THIS INCLUDES ALL MEDICAL CARE INCLUDING THE REMOVING OF THESE DISABLING PAINFUL HOT PIECES OF IRON IN HIS BACK. HE HAS BEEN UNABLE TO WORK SINCE THIS OPERATION. HE LOST HIS JOB, WIFE, MONEY, FAMILY, AUTOMOBILE, HOME, SOCIAL CONTACTS AND ABILITY TO BE PRODUCTIVE. HE HAS BEEN FORCED TO FILE BANKRUPTCY. RPTR HAD A KNEE AND LEG INJURY, THE RESULT OF HIS LATEST FALL. THE FALL WAS CAUSED BY A VERY HOT, SHARP, FLASHING PAIN IN HIS BACK. THIS WAS ONE OF MANY FALLS THIS INJURY CAUSED HIM, HOWEVER, THIS WAS THE WORST FALL SO FAR. RPTR IS INTERESTED IN THE PRESENT AND FUTURE ACTION BEING TAKEN BY THE FDA AGAINST THE MFR AND THE OTHER RESPONSIBLE PARTIES FOR THESE DANGEROUS AND MISCONCEIVED MEDICAL IMPLANTS. RPTR WOULD LIKE FDA TO CONTINUE TO PURSUE THE DANGERS OF THE PEDICLE PLATES AND SCREW IMPLANTATION AND GET THEM OFF THE MARKET AT ONCE. FROM DR'S NOTE DATED 12/16/95: "53-YR-OLD MALE WHO APPROX 10 DAYS AGO FELL LANDING ON HIS RIGHT KNEE. HE HAD MILD SWELLLING AT THAT TIME WHICH HAS PERSISTED, BECOMING MORE PAINFUL, RED AND HOT. HE WAS EVALUATED BY ANOTHER DR THE DAY BEFORE WHO THOUGHT HE HAD A POSSIBLE INFECTION. HIS CHRONIC CONDITION WHICH HAS RESULTED FROM AN INJURY AND TWO BACK SURGERIES HAS DEPRESSED THE PT TO THE POINT WHERE HIS CHRONIC PAIN IS A DAILY OCCURRENCE AND CAUSES MILD DEPRESSION AND ANXIETY AS WELL. HE CONSIDERS PT TO STILL HAVE A DIAGNOSIS OF DISABLING NEUROGENIC CLAUDICATION OF THE LS SPINE WITH REFERRED PAINS TO THE LEG AND FOOT. THIS CONDITION PREVENTS HIM FROM DOING ANY TYPE OF WORK WHICH WOULD REQUIRE HIM TO STAND OR SIT OR MOVE OR WALK OVER MORE THAN A 30-MIN PERIOD, 45 MINS BEING HIS ABSOLUTE LIMIT. A FURTHER FINDING TO CORROBORATE THE DIAGNOSIS OF SEVERE NERVE ROOT COMPRESSION IS THAT THE SOLE OF THE PT'S LEFT FOOT IS COMPLETELY NUMB TO PIN PRICK AND LIGHT TOUCH. HIS LOW BACK RANGE OF MOTION WAS LESS THAN 20 DEGREES IN ALL DIRECTIONS. (*)
TUBINGS ARE BREAKING IN HALF AT THE DRIP CHAMBER.
WHILE CNA'S WERE ATTENDING A FACILITY RESIDENT WITH A WHIRLPOOL BATH, SAFETY DEVICE RELEASED AND RESIDENT FELL TO FLOOR. RESIDENT SUBSEQUENTLY DIED. UPON FURTHER INVESTIGATION, ON 3/26/96 IT WAS DISCOVERED THAT GROMMETS WERE MISSING AND BOTH BELT BUCKLES HAD WHAT APPEARED TO BE STRESS FRACTURES.
RED CATHETER IN CATHETER KIT DEFECTIVE AND DID NOT ALLOW URINE TO EXIT BLADDER. PT HAD TO BE CATHETERIZED A SECOND TIME.
GUIDE WIRE DOES NOT PULL OUT EASILY AND FRAGMENTS DURING REMOVAL. DIFFICULT TO GUIDE THE TUBE THROUGH MOUNTING PIECE (TO SKIN). THIS IS VERY DANGEROUS AND COULD LEAVE A PIECE OF WIRE IN A PT.
THE PUMPS RAISE BAG ALARM WENT OFF WHEN BAG WAS SET UP RIGHT OVER PUMP.
MONITOR WILL NOT CHARGE. IT WAS PLUGGED IN FOR 24 HRS AND WOULD NOT HOLD THE CHARGE. RPTR TESTED THE PUMP AND FOUND THE SAME PROBLEM.
PLASTIC CONNECTOR WHICH ALLOWS ENDOTRACHEAL TUBE TO ATTACH TO BREATHING CIRCUIT SEPARATES FROM TUBE DESPITE HAVING BEEN TIGHTENED PRIOR TO INTUBATION.
RPTR WAS DOING CHEST COMPRESSIONS ON CARDIAC ARREST PT WITH AICD IMPLANT WHEN HE RECEIVED A SHOCK SIGNIFICANT ENOUGH TO CAUSE NUMBNESS TO ENTIRE RIGHT SIDE OF BODY, HEADACHE, NAUSEA AND SUSTAINED SINUS TACHYCARDIA. RPTR WAS HOSPITALIZED FROM 2/4 - 2/6/96.
PT UNDERWENT CAROTID ENDARTERECTOMY 3/28/96. POST-OP COURSE UNREMARKABLE AND DISCHARGED TO HOME 3/30/96 AT 11:46 AM. READMITTED 3/31 AT 1:08 THROUGH EMERGENCY DEPT FOR BLEEDING. TAKEN TO OR AND FOUND RUPTURED GRAFT AND LARGE BLOOD LOSS. PHYSICIAN FEELS RUPTURE DUE TO STAPLES AND APPLIER SYSTEM THAT WERE BEING TRIALED.
ENDOSCOPIC RETRACTOR FAILED TO CLOSE FOR REMOVAL FROM ABDOMINAL CAVITY.
RETRACTOR HANDLE/KNOB FOR OPERATION BROKE DURING USE WHILE BLADES WERE AT A RIGHT ANGLE AND FANNED. THIS MADE IT MOST DIFFICULT TO REMOVE FROM CAVITY.
VAPORIZER DISPLAYS NON-OPERATIONAL STATUS PER SELF-DIAGNOSIS SYSTEM. UNUSUALLY HIGH OCCURRENCE RATE PER MFR'S DEVICE TECHNICIAN.
OCCLUSION SPRINGS SNAPPED ON THE BLOOD PUMP ROTOR ASSEMBLY OF THE HEMODIALYSIS MACHINE. DIALYSIS TECH NOTICED THAT ARTERIAL PRESSURE WAS NOT REGISTERING. PT WAS MOVED TO ANOTHER DIALYSIS MACHINE AND TREATMENT WAS RESUMED. BIOMEDICAL SPECIALIST INSPECTED UNIT AND FOUND BROKEN SPRINGS IN BLOOD PUMP ROTOR ASSEMBLY. SAME FAILURE HAS OCCURRED TWICE ON ANOTHER MACHINE IN THE SAME INTERMEDIATE DIALYSIS UNIT. MACHINE REPAIRED AND PLACED BACK INTO SVC.
OCCLUSION SPRINGS SNAPPED ON THE BLOOD PUMP ROTOR ASSEMBLY OF THE HEMODIALYSIS MACHINE. DIALYSIS TECH NOTICED THAT ARTERIAL PRESSURE WAS NOT REGISTERING. PT WAS MOVED TO ANOTHER DIALYSIS MACHINE AND TREATMENT WAS RESUMED. BIOMEDICAL SPECIALIST INSPECTED UNIT AND FOUND BROKEN SPRINGS IN BLOOD PUMP ROTOR ASSEMBLY. SAME FAILURE HAD OCCURRED ON 4/6/96. UNIT REPAIRED AND PLACED BACK INTO SVC.
OCCLUSION SPRINGS SNAPPED ON THE BLOOD PUMP ROTOR ASSEMBLY OF THE HEMODIALYSIS MACHINE. DIALYSIS TECH NOTICED THAT ARTERIAL CHAMBER WOULD NOT MAINTAIN A CONSTANT FLOW AND THAT ARTERIAL AND VENOUS PRESSURES WERE REGISTERING LOW. PT WAS MOVED TO ANOTHER DIALYSIS MACHINE AND TREATMENT WAS RESUMED. BIOMEDICAL SPECIALIST INSPECTED UNIT AND FOUND BROKEN SPRINGS IN BLOOD PUMP ROTOR ASSEMBLY. UNIT REPAIRED AND PLACED BACK INTO SVC.
SURGICAL FIRE OCCURRED WHEN TRAPPED FUMES FROM SOLUTION WERE IGNITED BY A ELECTROSURGICAL PENCIL. PT SUSTAINED A 2ND-3RD DEGREE BURN TO RIGHT NECK ABOUT 4 X 6 CM.
NON-FUNCTIONING PENILE PROSTHESIS WAS REMOVED.
MAMMARY IMPLANT REMOVED DUE TO SPONTANEOUS DEFLATION.
RUPTURED, MALFUNCTIONING PENILE PROSTHESIS REMOVED.
AICD WOULD NOT RESPOND TO MAGNET OR PROGRAMMER. DEVICE EXPLANTED AND REPLACED.
MOTHER DISCOVERED PLASTIC "WINGS" OF NEEDLE "BROKEN OFF" EARLY AM OF 3/20/96 WHEN CHILD AROSE. MOTHER WAS ABLE TO REMOVE NEEDLE AND REACCESS PAC.
A DUAL PUMP UNIT WAS REPORTED FOR NOT DELIVERING THE INDICATED VOLUMES TO THE PT. THE PUMP APPEARED TO BE FUNCTIONING AND NO ALARMS DISPLAYED. THE PUMP WAS INFUSING TPN THROUGH A NITROGLYCERINE TUBING. AT ONE POINT THE PUMP WAS STOPPED FOR A PERIOD OF TIME AND THEN RESTARTED. THE DISPLAY ON THE FRONT OF THE PUMP INDICATED THAT THE UNIT WAS DELIVERING AT THE SET RATE AND WAS OPERATING CORRECTY. A FEW HOURS LATER, THE SOLUTION BAG STILL CONTAINED THE FULL AMOUNT OF TPN. WHEN THE DOOR OF THE PUMP WAS OPENED, THE TUBING WAS KINKED AND OCCLUDED, THE PUMP DID NOT REGISTER AN ALARM CONDITION. THE PUMP WAS TAKEN OUT OF SVC AND EVALUATED USING THE NITROGLYCERINE TUBING FROM THE ORIGINAL EVENT. AFTER SEVERAL TRIALS, AN OCCLUSION WITHOUT ALARM WAS CREATED. BY PLACING THE TUBING INTO THE PUMP MECHANISM WITH ENOUGH SLACK TO ALLOW THE TUBING TO BECOME CAUGHT IN THE GUIDES AS THE DOOR WAS CLOSED, THE PUMP WOULD ACTIVATE AND START THE DELIVERY CYCLE WITHOUT DETECTING THE OCCLUSION CONDITION. CONCLUSION: THE OPERATION OF THE INFUSION PUMP REQUIRES THAT THE END USER FOLLOW VERY SPECIFIC PROTOCOLS WHEN SETTING UP AN INFUSION PUMP FOR USE ON A PT. HUMAN FACTOR DESIGN CONSIDERATIONS DO NOT APPEAR TO HAVE BEEN AN INTEGRAL COMPONENT OF THE DEVELOPMENT OF THIS PUMP. SUCCESSFUL OPERATION OF THE PUMP AND ITS ALARMS DEPENDS UPON A VERY SPECIFIC SET OF END-USER PROTOCOLS, YET THERE IS NO PROACTIVE MECHANISM FOR THE PUMP TO ALERT THE USER THAT ONE OF THE NECESSARY STEPS WAS NOT PERFORMED CORRECTLY (INSTALLING THE TUBING TO THE CORRECT TAUTNESS). ANY SCENARIO THAT ALLOWS AN UNDETECTED OCCLUSION TO EXIST WITHOUT AN ALARM WILL CONTINUE TO RESULT IN SIMILAR PROBLEMS FOR ALL USERS. (ALSO SEE 1008908).
A SINGLE PUMP UNIT WAS REPORTED FOR NOT DELIVERING THE INDICATED VOLUMES TO THE PT. THE PUMP APPEARED TO BE FUNCTIONING AND NO ALARMS DISPLAYED. THE SINGLE PUMP DEVICE HAD BEEN IN USE FOR A PERIOD OF TIME BEFORE DELIVERY WAS INTERRUPTED. WHEN THE PUMP WAS RE-ACTIVATED, THE DISPLAY INDICATED THAT THE PUMP WAS OPERATING PROPERLY. SOME TIME LATER IN THAT SHIFT, THE IV BAG WAS STILL FULL AND IT WAS OBSERVED THAT THERE WERE NO DROPS FALLING IN THE DRIP CHAMBER. WHEN THE PUMP DOOR WAS OPENED, THE IV TUBING WAS KINKED, AND NO ALARM HAD SOUNDED. THE TUBING WAS REPLACED, THE PUMP RESTARTED AND THE IV ADMINISTRATION PROCEEDED NORMALLY. AT THE END OF THE SHIFT THE PUMP WAS REMOVED FROM SVC. EVALUATION OF THE PUMP SHOWED THAT THE EVENT COULD BE REPEATED BY PLACING THE TUBING INTO THE PUMP MECHANISM WITH A LITTLE SLACK IN THE TUBING LINE. WITH THE TUBING SLACK, THE PERISTALTIC ACTION OF THE PUMP WOULD CRIMP THE TUBING CREATING AN OCCLUSION DIRECTLY OVER THE PERISTALTIC MECHANISM. WITH A CRIMP IN THIS LOCATION, THE OCCLUSION DETECTORS APPEAR UNABLE TO RESPOND TO THE OCCLUSION. CONCLUSION: THE OPERATION OF THE INFUSION PUMP REQUIRES THAT THE END USER FOLLOW VERY SPECIFIC PROTOCOLS WHEN SETTING UP AN INFUSION PUMP FOR USE ON A PT. HUMAN FACTOR DESIGN CONSIDERATIONS DO NOT APPEAR TO HAVE BEEN AN INTEGRAL COMPONENT OF THE DEVELOPMENT OF THIS PUMP. SUCCESSFUL OPERATION OF THE PUMP AND ITS ALARMS DEPENDS UPON A VERY SPECIFIC SET OF END-USER PROTOCOLS, YET THERE IS NO PROACTIVE MECHANISM FOR THE PUMP TO ALERT THE USER THAT ONE OF THE NECESSARY STEPS WAS NOT PERFORMED CORRECTLY (INSTALLING THE TUBING TO THE CORRECT TAUTNESS). ANY SCENARIO THAT ALLOWS AN UNDETECTED OCCLUSION TO EXIST WITHOUT AN ALARM WILL CONTINUE TO RESULT IN SIMILAR PROBLEMS FOR ALL USERS. (ALSO SEE 1008907).
END CAPS ON EXTENSION SETS ARE HARD TO REMOVE. IN SOME CASES A FORCEPS IS REQUIRED TO REMOVE THE END CAP. END CAPS ON OTHER ADMIN SETS BY MFR REMOVE WITHOUT THIS PROBLEM. IT SEEMS THAT THE END CAPS ON THESE EXTENSION SETS ARE OF A DIFFERENT DESIGN THEN THE OTHER SETS. THIS SET CAN PRESENT MAJOR PROBLEMS DURING EMERGENCY SITUATIONS. RPTR HAS BEEN INFORMED THAT THIS HAS BEEN AN ONGOING PROBLEM FOR THE PAST YEAR. SO THIS CANNOT BE A LOT NUMBER PROBLEM BUT A DESIGN PRBLEM.
RPTR HAD DIFFICULTY GETTING BAG TO EXPAND FULLY DURING USE. BAG DID NOT REFILL COMPLETELY WHICH PREVENTED ADEQUATE VENTILATION. PROBLEM WAS DUPLICATED LATER IN CONTROLLED ENVIRONMENT.
PT HAD IV IN RIGHT HAND. AT 1700, NURSE FOUND PT'S RIGHT HAND AND RIGHT ARM SWOLLEN AND DISCOLORED. PUMP WAS NOT ALARMING OF INFILTRATION. THE IV WAS DISCONTINUED.
RPTR'S FACILITY WAS USING MULTIDOSE VIAL OF ZEMURON 10 MG/ML (ROCURONIUM BROM, DR). THEY USE BLUNT CANNULAS. THE FIRST TIME ENTRY CAUSES RUBBER FROM TOP OF VIAL TO ENTER VIAL. RUBBER HAS POTENTIAL TO BE SUCKED BACK INTO THE DELIVERY VIAL AND INJECTED INTO THE PT'S CIRCULATORY SYSTEM. THEY ARE CHANGING THEIR SYSTEM BACK TO USING SHARPS TO RETRIEVE MED FOR ANESTHESIA.
RPTR HAD TMJ SURGERY IN 1982. THE DR USED MFR'S IMPLANTS. ALTHOUGH SHE COMPLAINED MANY, MANY TIMES SHE WAS IGNORED BY THE ATTENDING PHYSICIAN. SHE HAS BEEN CHRONICALLY ILL SINCE THE IMPLANTS WERE PUT IN HER JAWS AND SHE WILL BE ILL UNTIL HER DEATH AS A RESULT OF THE BREAKING UP OF THESE IMPLANTS THAT DISSOLVED INTO HER BODY. THERE IS NO CURE AND THERE ARE NO SURGERIES THAT CAN HELP THE DAMAGE DONE TO HER BODY AS A RESULT OF THE IMPLANTS AND SHE IS CONSIDERED UNEMPLOYABLE. SHE HAS HAD NO FINANCES AVAILABLE TO SEEK MEDICAL ATTENTION SINCE 1994. SHE DID NOT HAVE MEDICAL COVERAGE AND SHE CANNOT OBTAIN MEDICAID. THE GOVERNMENT STATED SHE IS NOT SICK ENOUGH. HRS REJECTED HER CASE IN 1996. C/O ANXIETY, FIBROMYALGIA, EYESIGHT PROBLEMS, DEPRESSION, CYSTS ON BOTH KIDNEYS, SEVERE JAW PROBLEMS, CHRONIC FATIGUE, SLEEP DISORDER, DAILY PAIN. (ALSO SEE 1008914)
RPTR HAD TMJ SURGERY IN 1982. THE DR USED MFR'S IMPLANTS, ALTHOUGH SHE COMPLAINED MANY, MANY TIMES SHE WAS IGNORED BY THE ATTENDING PHYSICIAN. SHE HAS BEEN CHRONICALLY ILL SINCE THE IMPLANTS WERE PUT IN HER JAWS AND SHE WILL BE ILL UNTIL HER DEATH AS A RESULT OF THE BREAKING UP OF THESE IMPLANTS THAT DISSOLVED INTO HER BODY. THERE IS NO CURE AND THERE ARE NO SURGERIES THAT CAN HELP THE DAMAGE DONE TO HER BODY AS A RESULT OF THE IMPLANTS AND SHE IS CONSIDERED UNEMPLOYABLE. SHE HAS HAD NO FINANCES AVAILABLE TO SEEK MEDICAL ATTENTION SINCE 1994. SHE DID NOT HAVE MEDICAL COVERAGE AND SHE CANNOT OBTAIN MEDICAID. THE GOVERNMENT STATED SHE IS NOT SICK ENOUGH. HRS REJECTED HER CASE IN 1996. C/O ANXIETY, FIBROMYALGIA, EYESIGHT PROBLEMS, DEPRESSION, CYSTS ON BOTH KIDNEYS, SEVERE JAW PROBLEMS, CHRONIC FATIGUE, SLEEP DISORDER, DAILY PAIN. (ALSO SEE 1008913)
PT SUFFERED FROM ALZHEIMER'S AND HAD BECOME TOTALLY DISABLED. RPTR HAD ACQUIRED A HOSP BED WITH RAILS TO KEEP HER SAFE AT NIGHT. DURING HER NIGHT TIME TOSSING, SHE BECAME TRAPPED BETWEEN THE LOWEST RAIL AND THE MATTRESS AND SUFFOCATED. THE RAILINGS WERE 2 1/4" AWAY FROM THE OUTER EDGE OF THE MATTRESS. THE MATTRESS WAS APPROX 4" THICK. ALL OF HER TORSO WAS OUTSIDE OF THE BED WITH HER SHOULDERS, RIGHT ARM AND HEAD FACING DOWN INTO THE BEDDING WITHIN THE LOWEST RAIL. ALTHOUGH PT WAS BEING CARED FOR IN RPTR'S HOME, SHE IS A FULL TIME HOME WORKER CARING FOR DEVELOPMENTALLY AND PHYSICLLY CHALLENGED ADULTS AND HAS WORKED IN HUMAN SVC SINCE 1974, HAVING BEEN EXTENSIVELY TRAINED. (ALSO SEE 1008916).
PT SUFFERED FROM ALZHEIMER'S AND HAD BECOME TOTALLY DISABLED. RPTR HAD ACQUIRED A HOSP BED WITH RAILS TO KEEP HER SAFE AT NIGHT. DURING HER NIGHT TIME TOSSING, SHE BECAME TRAPPED BETWEEN THE LOWEST RAIL AND THE MATTRESS AND SUFFOCATED. THE RAILINGS WERE 2 1/4" AWAY FROM THE OUTER EDGE OF THE MATTRESS. THE MATTRESS WAS APPROX 4" THICK. ALL OF HER TORSO WAS OUTSIDE OF THE BED WITH HER SHOULDERS, RIGHT ARM AND HEAD FACING DOWN INTO THE BEDDING WITHIN THE LOWEST RAIL. ALTHOUGH PT WAS BEING CARED FOR IN RPTR'S HOME, SHE IS A FULL TIME HOME WORKER CARING FOR DEVELOPMENTALLY AND PHYSICLLY CHALLENGED ADULTS AND HAS WORKED IN HUMAN SVC SINCE 1974, HAVING BEEN EXTENSIVELY TRAINED. (ALSO SEE 1008915).
DERMATOME BLADE LOOSENED DURING USE CAUSING LACERATION NEAR ILIAC CREST. SURGEON ADAPTED GRAFT PROCEDURE SO NO ADVERSE OUTCOME.
FEMORAL ROD GUIDE DEVICE BROKE DURING USE. NO FRAGMENT REMAINED IN PT.
COMPLAINANT STATED THAT HIS SON WAS PLACED ON AN EXTRACORPOREAL MEMBRANE OXYGENATION DEVICE (ECMO) DURING HIS STAY AT THE HOSP. COMPLAINANT STATED THE MACHINE DAMAGED THE CHILD'S ONLY KIDNEY. HE ALSO STATED THAT THE DEVICE IS EXPERIMENTAL AND HE WAS COERCED INTO SIGNING THE CONSENT FORM, WHICH ALLOWED THE DOCTORS TO PLACE PT ON THE ECMO MACHINE. PT WAS BORN ON 1/7/96 SINCE HE WAS BREECH, AN EMERGENCY CESAREAN SECTION WAS PERFORMED. HE WAS EXAMINED APPROX ONE HOUR AFTER BIRTH BY THE PEDIATRICIAN, WHO STATED HE WAS A HEALTHY BABY. APPROX FIVE HOURS AFTER BIRTH THE NURSE NOTED COMPLICATIONS, IN PT'S LEFT LUNG. ON 1/8/96 AT APPROX 5:00 PM, THE RESIDENT ON CALL, ASKED COMPLAINANT TO SIGN A CONSENT FORM. COMPLAINANT CLAIMS HE WAS NOT GIVEN THE ENTIRE CONSENT FORM AND WAS ONLY GIVEN THE PAGES THAT NEEDED HIS SIGNATURE. HE STATED HE WAS TOLD BY THE DR THAT IF HE DID NOT SIGN THE CONSENT FORM, THE HOSP WOULD GET A COURT ORDER TO PLACE PT ON THE ECMO MACHINE. COMPLAINANT STATED THE DR SAID HE COULD NOT ANSWER ANY QUESTIONS CONCERNING THE ECMO MACHINE BECAUSE THIS WAS A MEDICAL EMERGENCY AND HE HAD TO PLACE PT ON THE ECMO MACHINE IMMEDIATELY OR HE WOULD DIE. COMPLAINANT STATED PT DID NOT RECEIVE THE SURGERY TO PLACE HIM ON THE ECMO MACHINE UNTIL THREE HOURS AFTER HE SIGNED THE CONSENT FORM. PT WAS PLACED ON THE ECMO MACHINE ON 1/8/96 AND WAS TAKEN OFF THE MACHINE ON 1/14/96. COMPLAINANT STATED THE NURSE STATED PT WAS TAKEN OFF THE ECMO MACHINE BECAUSE HE HAD HEMORRHAGED FROM THE BRAIN AND KIDNEY. ON 1/17/96, COMPLAINANT WENT TO VISIT THE PT IN THE HOSP AND THE KIDNEY SPECIALIST, STATED HE HAD THREE DAYS TO LIVE. ON 1/19/96 PT WAS TRANSFERRED TO ANOTHER HOSP. ON 2/2/96, PT CAME HOME FROM THE HOSP. COMPLAINANT STATED HE IS CURRENTLY STABLE, BUT WILL HAVE TO HAVE A KIDNEY TRANSPLANT WHEN HE REACHES 20 LBS. (*)
THE PT OFFERED NO COMPLAINTS OF PRE-TREATMENT. TWO HRS INTO THE TREATMENT, PT COMPLAINED OF NUMBNESS AND TINGLING IN HIS HANDS. WHILE ASSESSING THE SITUATION, A KINK WAS NOTED IN THE ARTERIAL LINE. THE PT'S BLOOD WAS TRANSLUCENT IN COLOR. THE TREATMENT WAS DISCONTINUED AND THE BLOOD WAS NOT RETURNED TO THE PT. BP 120/60 P 80+REG. THE PHYSICIAN WAS NOTIFIED. THE PT BEGAN TO COMPLAIN OF ABDOMINAL PAIN. HE WAS TRANSPORTED TO THE HOSP FOR EVALUATION.
ONE HOUR INTO DIALYSIS TREATMENT IT WAS NOTED THAT MACHINE WAS REMOVING MORE FLUID THAN THE GOAL. MACHINE WAS ALSO LEAKING FLUID. VENOUS LINE HAD KINKED AND WAS CHANGED. TOTAL FLUID TO BE REMOVED WAS 3000 CC. AFTER 80 MINS, MONITOR INDICATED 958 CC REMOVED 300 CC OF SALINE WAS GIVEN. PT WAS MOVED TO ANOTHER MACHINE AND ORIGINAL MACHINE WAS PULLED. NEW GOAL SET FOR 1.2 KILOS PER HR. 2 HRS LATER PT COMPLAINED OF CHEST PAIN. UF TURNED OFF. BP 134/83. OXYGEN THERAPY WAS INITIATED AND PT WAS PLACED ON A CARDIAC MONITOR. SYMPTOMS SUBSIDED, TREATMENT WAS TERMINATED. POST WEIGHT WAS 1.2 KGS BELOW GOAL. SHORTLY AFTER HAVING TREATMENT, PT BEGAN VOMITING. PT RETURNED TO TREATMENT. NEEDLE WAS INSERTED AND 500CC NSS WAS GIVEN. PHYSICIAN WAS NOTIFIED. DISCHARGE .4 KGS BELOW DRY WEIGHT. FIRST MACHINE WAS PULLED AND CHECKED. PROBLEM WITH UF PUMP WAS NOTED. INLET HOSE REPLACED. IT IS UNCLEAR WHETHER PRESSURE HOLDING TEST WAS COMPLETED PRIOR TO INITIATION OF TREATMENT. NO HOSPITALIZATION REQUIRED.
THE PT EXPERIENCED HYPOTENSION (BP 66/41) NAUSEA AND BRADYCARDIA (PULSE 44) AT THE END OF A 3 1/4 HR DIALYSIS TREATMENT. THE PT WAS CONNECTED TO A CARDIAC MONITOR AND GIVEN O2 AT 3L. THE PHYSICIAN EXAMINED THE PT AND SHE WAS TRANSFERRED TO THE HOSP AND ADMITTED FOR FURTHER EVAULATION. THE SECOND PT, WHO WAS DIALYZED ON THE SAME MACHINE ON THIS DATE, EXPERINECED NAUSEA AND REPORTED "FEELING BAD" NEAR THE END OF DIALYSIS. TREATMENT WAS TERMINATED AND THE PT WAS GIVEN SALINE. THE PT WENT HOME AFTER TREATMENT. FOLLOW-UP WAS DONE WITH THE PT THE NEXT DAY AND THE PT'S WIFE REPORTED THAT THE PT VOMITED LATER IN THE EVENING AND FELT WEAK. THE MACHINE WAS REMOVED FROM SVC ON 9/4 FOLLOWING THE SECOND PT REPORTING SYMPTOMS. A FUNCTIONAL CHECK WAS PERFORMED AND NO PROBLEMS WERE IDENTIFIED. ON 9/5/95 THE MACHINE WAS AGAIN REMOVED FROM SVC DUE TO LOW CONDI. NO PTS HAD DIALYZED ON THE MACHINE. VOLUMES WERE RECALIBRATED ON THE ACID AND BICARB PUMPS AND THE BICARB TEE WAS REPLACED. ON 9/6/95 THE MACHINE WAS PUT BACK INTO SERVICE. THE FIRST PT WHO DIALYZED ON THIS MACHINE REPORTED NAUSEA AND "FEELING BAD" TWO HRS INTO DIALYSIS. BP 93/60, PULSE 75, TEMP 95.7. THE PT APPEARED ANXIOUS AND RESTLESS. THE MACHINE CONDUCTIVITY ALARMED AS THE PT'S TREATMENT WAS BEING TERMINATED. DIALYSIS WAS RESUMED ON ANOTHER MACHINE. THE PT'S SYMPTOMS IMPROVED AND TREATMENT WAS COMPLETED.
PT OFFERED NO COMPLAINTS PRE-TREATMENT. SHE WAS PUT ON A PRE-PROCESSED DIALYZER WITHOUT PROBLEM. WITHIN 5 MINS SHE COMPLAINED OF BACK PAIN. CHARGE NURSE NOTIFIED AND BLOOD RETURNED TO THE PT. SHE THEN C/O NAUSEA AND VOMITED. O2 WAS STARTED AT 3L FOR CHEST PAIN WHICH SUBSIDED. SHE WAS RESTARTED ON A DRY PACK, FLUSHED WITH 3L OF NS. THE REMAINDER OF THE TREATMENT WAS UNEVENTFUL.
PT RECEIVED 60MG OF MORPHINE IN 90 MINS DUE TO FAULTY SYRINGE. PT WAS CLOSELY OBSERVED. INCREASED SOMNOLENCE WAS NOTED.
NURSE HAD GIVEN INJECTION TO A PT IN A SEMI-PRIVATE ROOM. WHEN SHE ATTEMPTED TO DISPOSE OF NEEDLE INTO SHARPS CONTAINER, USED NEEDLE WAS CATAPULTED OUT OF TRAY AND STUCK THE OTHER PT, WHO WAS SEATED NEARBY. ROUTINE BASELINE HEPATITIS AND HIV PROFILE TESTS WERE PERFORMED. MFR REP CONDUCTED INVESTIGATION ON 12/19/95.
INJURY WAS SUSTAINED BY HOSP EMPLOYEE. AN LPN AT THIS FACILITY HAD INJECTED A PT AND ATTEMPTED TO EMPTY A SYRINGE DEVICE INTO A SHARPS DISPOSABLE BOX. SHE CLAIMED THE SYRINGE DID NOT RELEASE THE NEEDLE FULLY AND WHEN SHE WITHDREW IT, THE NEEDLE PIERCED HER RIGHT SLEEVE AND STUCK IN RIGHT FOREARM. EMPLOYEE WAS CHECKED BY EMPLOYEE NURSE AND WAS REFERRED TO PHYSICIAN. HIV AND HEPATITIS PROFILES PERFORMED.
RESIDENT PLACED ON LIFT AND REMOVED FROM WHIRLPOOL. SAFETY STRAP POPPED OPEN AND RESIDENT FELL TO FLOOR. PRESSURE WAS APPLIED TO LACERATION ON THE HEAD AND TRANSPORTED PER EMS STRETCHER TO HOSP.
PT WAS BEING TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT. THE PT WAS BEING ADMINISTERED MULTIPLE VASO-ACTIVE DRUGS VIA THE IV PUMP. THE PUMP STOPPED PUMPING DUE TO A DEPLETED BATTERY WHICH CAUSED THE PT'S VITAL SIGNS TO BECOME UNSTABLE FOR A PERIOD OF TIME AFTER THE IV PUMP WAS REPLACED. A STUDY WAS PERFORMED TO DETERMINE THE RUN TIME OF THIS PUMP WITH ALL FOUR CHANNELS OPERATING AT 125 ML PER HR. THE SPECIFICATIONS CALL FOR THE UNIT TO OPERATE FOR 3.5 HRS BEFORE ALARMING LOW BATTERY. IT THEN CONTINUES TO OPERATE 30 MINS IN ALARM CONDITION AND AFTER 30 MINS STOPS PUMPING. THIS DEVICE, WHEN TESTED, OPERATED FOR ONLY 34 MINS BEFORE TURNING OFF WITHOUT ALARMING. THE BATTERIES WERE TESTED, FOUND TO HAVE A LOW CAPACITY, AND REPLACED. THE NEW BATTERIES POWERED THE DEVICE FOR 3 HRS BEFORE TURNING OFF. THE MFR CAME ON SITE TO REPEAT THE TEST AND OBTAINED THE SAME RESULTS. FURTHER TESTS WERE CONDUCTED AT RANDOM ON TWO OTHER PUMPSSAME MODEL. BOTH FAILED IN 30 MINS. ALL THE BATTERIES, WHICH WERE FROM THE SAME MFR LOT NUMBER, WERE REPLACED DURING AN UPGRADE IN MARCH. NEW BATTERIES WERE ORDERED FOR ALL 50 OF THIS MODEL PUMP AND WERE REPLACED ON 8/30/95. THIS SHOULD RESOLVE THE PREMATURE LOW BATTERY SHUT DOWN PROBLEM.
PT IS A 13-YR-OLD WITH SEVERE CEREBRAL PALSY, MENTAL RETARDATION, AND VENTILATOR DEPENDENCE. HE HAD A TRACHEOSTOMY PERFORMED ON 5/12/95 AND WAS DISCHARGED FROM FACILITY ON 5/20/95 ON HOME MECHANICAL VENTILATION VIA HIS TRACH. HE RETURNED TO CLINIC ON 8/29/95. AT THAT VISIT THE FATHER NOTED THAT HIS TRACH HAD BEEN FOUND BY HIM WITH THE SHAFT SEPARATED FROM THE WINGS. HE WAS BARELY ABLE TO PULL THE SHAFT FROM THE TRACH STOMA BEFORE IT OCCLUDED THE TRACHEAL LUMEN COMPLETELY. THE TRACHEOSTOMY TUBE WAS REPLACED BY THE FATHER WITHOUT APPARENT PROBLEM FOR THE PT.
PT HAS HAD A HISTORY OF FREQUENT FALLING SPELLS AND COMPLAINTS OF RAPID HEART RATE. UNABLE TO DOCUMENT PACEMAKER MALFUNCTION, BUT DEVICE AND LEAD ARE UNDER RECALL AND PT WISHES TO HAVE LEAD REMOVED. ANOTHER CO'S EXTRACTION SYSTEM WAS USED. LEAD WAS REMOVED EXCEPT FOR ANODE (TIP OF LEAD) THAT WAS ADHESED TO VENTRICULAR. PACEMAKER WAS CHANGED. PT WAS DISCHARGED THE NEXT DAY.
PT ADMITTED TO HOSP SPECIAL CARE UNIT WITH DIAGNOSIS OF PNEUMONIA AND HISTORY OF SEVERE ARTHRITIS AND HYPERTENSION. AT 0824, ON 3/3/96, PT RESPIRATORY ARRESTED AND RESUSCITATION EFFORTS BEGAN. DEFIBRILLATOR WAS UNPLUGGED AND TAKEN TO THE BEDSIDE. THE PT'S HEART RHYTHM WAS NOTED TO BE ELECTRICAL MECHANICAL DISSOCIATION AT 0829. AT 0832 THE HEART RHYTHM WAS V-FIB. THE DEFIBRILLATOR WAS CHARGED TO 200 JOULES AND DISCHARGED PROPERLY. NURSE OBSERVED MUSCULAR RESPONSE OF PT IN RESPONSE TO DELIVERED SHOCK. THE LOW BATTERY INDICATOR LIGHT WAS NOTED TO BE ON AND THE DEFIBRILLATOR WAS PLUGGED IN. THE DEFIBRILLATOR WAS CHARGED TO 300 JOULES AND 300 CHARGE WAS DISPLAYED ON SCREEN. THE DEFIBRILLATOR FAILED TO DISCHARGE. THE CHARGE WAS DUMPED BY TURNING THE ENERGY SELECTION DIAL TO THE OFF SETTING. 300 JOULES WAS SELECTED FOR THE THIRD CHARGE. THE 300 CHARGE WAS DISPLAYED ON SCREEN. THE DEFIBRILLATOR FAILED TO DISCHARGE. THE CHARGE WAS DUMPED BY TURNING THE ENERGY SELECTION DIAL TO OFF. DURING THIS ATTEMPT TO DISCHARGE THE PLASTIC BUTTON COVER ON THE RIGHT PADDLE CAME OFF AND WAS NOT RECOVERED UNTIL AFTER THIS SCENARIO WAS CONCLUDED. 300 JOULES WAS SELECTED FOR THE FOURTH CHARGE. THE 300 CHARGE WAS DISPLAYED ON SCREEN. THE DEFIBRILLATOR FAILED TO DISCHARGE. THE CHARGE WAS DUMPED BY TURNING THE ENERGY SELECTION DIAL TO OFF. 300 JOULES WAS SELECTED FOR A FIFTH CHARGE. THE 300 CHARGE WAS DISPLAYED ON SCREEN. THE DEFIBRILLATOR DISCHARGED PROPERLY. NURSE OBSERVED MUSCULAR RESPONSE OF PT IN RESPONSE TO DELIVERED SHOCK. 360 JOULES WAS SELECTED FOR A SIXTH AND SEVENTH CHARGE. THE 360 CHARGES WERE DISPLAYED ON SCREEN. THE DEFIBRILLATOR DISCHARGED PROPERLY. NURSE OBSERVED MUSCULAR RESPONSE OF PT IN RESPONSE TO DELIVERED SHOCKS. THE PT DID NOT RESPOND TO RESUSCITATION EFFORTS AND WAS PRONOUNCED DEAD AT 0855. THE FOLLOW-UP INVESTIGATION CONFIRMED THAT THE BATTERY WAS WEAK. THE UNIT HAD NOT BEEN CHARGED SO INTEGRITY OF THE BATTERY WAS NOT DETERMINED. HOWEVER, THE BATTERY WAS LAST REPLACED IN 3/93. THE MFR RECOMMENDS REPLACING ANNUALLY. BIO-MEDICAL EQUIPMENT SVS CO HAD INSPECTED THE DEFIBRILLATOR 1/23/96, AND HAD THE UNIT ON A SIX (6) MONTH PREVENTIVE MAINTENANCE SCHEDULE (PM). THEY FOUND NOTHING WRONG WITH THE DEFIBRILLATOR AT THAT TIME. THE UNIT WAS CHECKED ON A/C POWER AND DELIVERED WITHIN SPECS DURING THE INVESTIGATION. THE A/C BUTTON ON THE SIDE OF TEH DEFIBRILLATOR WAS OBSERVED TO BE PUSHED IN. BIOMEDICAL SUMMARY: 1. THE RIGHT PADDLE BUTTON BROKE DURING THE CODE. 2. THE DEFIBRILLILATOR BATTERY WAS WEAK AND OUT OF DATE. 3. THE DEFIBRILLATOR WORKED FINE ON A/C POWER. 4. THERE IS A TWO (2) SECOND DELAY BETWEEN WHEN THE DIGITAL DISPLAY SHOWS FULL ENERGY AND WHEN ENERGY CAN BE DELIVERED TO THE PT. THIS POSES A POTENTIAL ERGONOMIC PROBLEM. (AT LOWER ENERGIES THERE IS LITTLE OR NO DELAY WITH THE UNIT.)
APPROX 2 1/2 HRS INTO HEMODIALYSIS TREATMENT, PT BECAME UNRESPONSIVE. PLACED IN TRENDELENBURG POSITION AND 0.9% SALINE ADMINISTERED WITH SPONTANEOUS RETURN OF PULSE AND RESPIRATIONS. PT HAD JUST PREVIOUSLY BEEN TAKEN OFF DIALYSIS TO GO TO BATHROOM. SHE THEN RETURNED AND TREATMENT WAS RESUMED. PT WAS TRANSFERRED TO HOSP. HEMOLYSIS WAS IDENTIFIED AT THE HOSP. HCT WAS 19.2 ON 4/9 FROM 29.3 ON 3/20. AMYLASE WAS 347. PT WAS TAKEN TO SURGERY FOR REMOVAL OF GALLBLADDER. PT EXPIRED ON 4/9/96.
ON 4/5/96, AS INITIAL REPORT WAS SUBMITTED, VIA FAX, REGARDING THE REPORTING OF AN INCIDENT INVOLVING A FACILITY RESIDENT, RESIDENT WAS BEING GIVEN A WHIRLPOOL BATH WHEN UPON COMPLETION THE RESIDENT FELL FROM WHIRLPOOL LIFT CHAIR AND FELL TO THE FLOOR. RESIDENT SUSTAINED HEAD INJURIES. RESIDENT SUBSEQUENTLY EXPIRED. THE WHIRLPOOL VENDOR WAS NOTIFIED ON INCIDENT ON 3/25/96. ON 3/26/96, VENDOR CAME TO FACILITY TO CHECK EQUIPMENT. VENDOR INFORMED FACILITY STAFF OF DEFECTIVE EQUIPMENT.
PT IS A 38-YR-OLD FEMALE WHO HAD A RIGHT SUBCLAVIAN INFUSION PORT PLACED ON 12/5/94 FOR CHEMOTHERAPY FOR CARCINOMA OF THE LEFT BREAST. UPON REMOVAL OF THE INFUSION PORT, IT WAS DETERMINED THE CATHETER WAS LESS THAN 10 CM IN LENGTH AND HAD A FRACTURED END. THE CATHETER TIP WAS LOCATED IN THE RIGHT ATRIUM. THE INFUSION PORT AND FRACTURED CATHETER WERE ALL REMOVED WITHOUT DIFFICULTY. NO POST-OP PROBLEMS WERE NOTED.
PT HAD ELECTIVE EXTRACTION OF PACEMAKER LEAD. ANOTHER CO'S EXTRACTION SYSTEM USED WITH NO COMPLICATIONS.
A 84-YR-OLD MALE WAS FOUND WITH FOLEY CATHETER OUT ON 9/25/95, BALLOON TIP MISSING, POSSIBLY STILL IN PT (#16 FRENCH FOLEY, SILICONE COATED LATEX, HAD BEEN PLACED ON 9/20/95). MD WAS INFORMED AND PT WAS MONITORED. VOIDING QS CLEAR YELLOW URINE, IN DIAPER. G/U CONSULTATION PERFORMED ON 9/26, CYSTOSCOPY PERFORMED ON 9/27, UNDER LOCAL ANESTHESIA, AND 8CM CATHETER TIP WAS RETRIEVED AND SENT TO PATHOLOGY. CATHETER WAS RETURNED TO MFR. NOTE: CYSTOSCOPY PERFORMED ON 9/27 AT APPROX 0755-0800. LATER IN DAY PT DEVELOPED RESPIRATORY DISTRESS, TRANSFERRED TO ICU, POSITIVE MI. BELIEVED TO BE UNRELATED TO CYSTOSCOPY PROCEDURE.
EXPLANTED BILATERAL SALINE FILLED BREAST IMPLANTS. PT ALSO HAD IMPLANTED ON 7/12/95 BILATERAL SALINE FILLED MAMMARY IMPLANT OF SMALLER SIZE.
PT WAS AT HOME, WOKE UP WITH THE ARTERIAL END OF THE CATHETER COMPLETELY FALLING OFF ON ITS OWN. CATHETER WAS IN THE RIGHT INTERNAL JUGULAR. CATHETER HAD BEEN USED FOR A COUPLE OF WEEKS. ON 8/20/95, HE CAME TO THE HOSP AND HAD IT REPAIRED, WITH STERILIZATION OF THE ARTERIAL TIP THAT WAS EXPOSED, REPLACEMENT OF THE ARTERIAL END WITH A NEW CATHETER TIP.
PT HAD BEEN SITTING IN HIS CHAIR AT HOME WHEN THE DISTAL END OF THE RIGHT ARTERIAL SITE OF THE CATHETER JUST FELL OUT. THE PT DID NOT DO ANYTHING TO CAUSE THAT PROBLEM, HE DOES NOT THINK, IT JUST FELL OUT. ON 8/24/95 THE PT HAD THE CATHETER REPAIRED.
A 49-YR-OLD POSTOP MALE WAS ON A RENTAL VENT. SETTING WAS CHANGED AT 1330. ABG WERE ORDERED FOR 1 HR LATER. TOLERATED CHANGE WELL, ALERT AND COMFORTABLE. AT 1430 PCXR PERFORMED, ET TAPE REDONE. PT WAS NOTED TO BE ANXIOUS AND SHORT OF BREATH. ATIVAN WAS GIVEN. ABG WERE POOR. RETURNED TO PREVIOUS SETTINGS. RESP TECH WITH PT, NOTED LESS RESPONSE TO UNRESPONSIVE. VENT ALARMING, PRESSURE LOSS NOTED. AMBUED, IMPROVED. PLACED ON NEW VENT AT 1530, RESPONSIVE. AT 1600 DENYING SHORTNESS OF BREATH; NO APPARENT SEQUELAE. EQUIP CHECKED BY BIOENG: NEG; THEN OBSERVED FOR 1 HR. UNEXPLAINED SIGNIFICANT LOSS OF FLOW, VOLUME, PRESSURE NOTED, VERIFYING TECH PROBLEM WITH MACHINE. MFR NOTIFIED.
PT STATED SHE "FELT BAD" PRE-TREATMENT. O2 STARTED AT 2L. HER ORDERED BLOODFLOW WAS 400ML BUT HAD TO BE DECREASED TO 300 DUE TO A POOR FLOW. TOWARD THE END OF HER 3 1/2 HR TREATMENT, SHE COMPLAINED OF HAVING "GAS" AND BURPED. HER BP DROPPED TO 114/60 BUT WENT BACK UP TO 130/60. HER TREATMENT FINISHED AND SHE LEFT THE UNIT TO GO BACK TO HER ROOM. LATER THAT DAY THE PHYSICIAN CALLED THE UNIT AND STATED THE PT'S LDH WAS 2000 AND THE PT'S BLOOD WAS HEMOLYZED. THE MGMT TEAM WAS THEN TOLD BY THE PT CARE TECH THAT A KINK WAS SEEN IN THE ARTERIAL LINE IN THE BLOOD PUMP HOUSING WHEN THE LINES AND DIALYZER WERE TAKEN OFF THE DIALYSIS MACHINE. THE LINES WERE DISCARDED.
PT HAD A MOTORCYCLE ACCIDENT AND HAD SURGERY ON 5/4/95 AND/OR 5/5/95 FOR COMPOUND RIGHT DISTAL FEMUR FRACTURE, RIGHT DISTAL RADIAL STYLOID FRACTURE, LEFT 2ND AND 3RD CARPAL-METACARPAL JOINT DISLOCATION, OPEN LEFT THIRD METACARPAL PHALANGEAL JOINT. HE HAD BEEN DOING WELL UNTIL 6/7/95 WHEN HE TRIPPED, STOOD ON HIS RIGHT LEG AND BENT THE ROD, ALSO THE 4TH METACARPAL ARTICULATION HAD SUBLUXED. HE WENT TO OR 6/8/95 FOR ORIF LEFT 4TH CARPAL METACARPAL JOINT WITH ORIF AND ROD EXCHANGE, EXTRACTION OF BROKEN ROD FRAGMENT RIGHT FEMUR. DR REMOVED THE ROD ONLY TO FIND THE DISTAL PORTION HAD NOT SIMPLY BENT BUT HAD BROKEN OFF AND LIKELY A STRESS FRACTURE THROUGH THE PROXIMAL DISTAL HOLE SECONDARY TO THE SCREW PLACEMENT. HE UNDERWENT AN EXTENSIVE PROCEDURE TO REMOVE THE ROD WITH AN OPEN REDUCTION OF THE BUTTERFLY FRAGMENT, A PROLONGED TIME TO REMOVE THE ROD THROUGH AN OPEN AND SEMIOPEN TECHNIQUE. CANNOT TELL IF THE SURGERY ON 6/8 FOR THIS METACARPAL WAS RELATED TO HIS TRIPPING OR NOT.
PT BROUGHT IN FOR PACEMAKER UPGRADE FROM VVI TO DDD MODE DUE TO PT'S C/O'S PACEMAKER SYNDROME. ATRIAL LEAD AND NEW GENERATOR IMPLANTED 9/9/95. 9/11/95 PT BROUGHT BACK TO CATH LAB TO REPOSITION ATRIAL LEAD AFTER OPENING POCKET. DR EXAMINED VENTRICULAR LEAD THAT HAD BEEN IMPLANTED SINCE 10/18/93 AND FOUND TO HAVE APPARENTLY INSULATION DEFECTS ON VENT LEAD. SEROUS FLUID COULD BE SEEN TRAVELING DOWN LEAD WITH MANUAL MOVEMENT OF LEAD. 3-4" OF THE PROXIMAL LEAD WAS REMOVED AND REST OF LEAD CAPPED. A NEW VENT LEAD WAS IMPLANTED.
PT SEEN FOR SPEECH THERAPY SESSION. COMA STIM PROVIDED CONSISTING OF ORAL COMMANDS, TACTILE STIMULATION TO ARMS, FEET, FACE, HANDS. AUDITORY STIMULATION PROVIDED. EMG ELECTRODES PLACED ON PT'S FACE, ONE ABOVE RIGHT EYEBROW, ONE ON CHEEKBONE BELOW RIGHT EYE AND THE OTHER IN RIGHT TEMPLE. DIFFICULTY GETTING THE BIOFEEDBACK PROGRAM TO WORK. EVENTAULLY DC/D SESSION. WHEN ELECTRODES WERE REMOVED SKIN WAS BROKEN IN THE SAME CIRCLE SHAPE UNDER THE ELECTRODE ABOVE THE EYE, BLACKENED IN A CIRCLE BELOW THE EYE AND BLISTERED ON THE TEMPLE BESIDE THE EYE. PHYSICIAN TREATED WITH SILVADENE CREAM AND LATER CHANGED TO NEOSPORIN OINTMENT.
PT HAD HYDROCEPHALUS SECONDARY TO AQUEDUCT STENOSIS AT BIRTH. HAD INITIAL STANDARD FLOW DENVER UNITIZED LOW PROFILE VENTRICULOPERITONEAL SHUNT 12/14/88. ON 8/5/94 PT HAD ELECTIVE LENGTHENING OF PERITONEAL END OF VP SHUNT. PT HAD DEVELOPED BEFORE ADMIT DETERIORATION OF INTELLECTUAL AND MENTAL FUNCTION INDICATING SHUNT WAS NOT WORKING. DURING THE SURGERY FOR REVISION OF SHUNT A TEAR IN THE PERITONEAL CATHETER 4 CM DISTAL TO VALVE WAS IDENTIFIED. (DATE OF LAST SURGERY 12/29/95).
TRANSECTION OF VASCULAR ACCESS CATHETER. PORT AND APPROX 2 INCHES OF CATHETER REMOVED THROUGH POCKET ON 2/14/95. PERCUTANEOUS RETRIEVAL OF DISTAL FRAGMENT (IN RIGHT ATRIUM) VIA RIGHT COMMON FEMORAL VEIN ON 2/14/95; TIP OF CATHETER NEAR RA/IVC JUNCTION.
WOUND DRAIN BROKE DURING REMOVAL. PT RETURNED TO SURGERY FOR REMOVAL OF DRAIN TIP.
DURING AORTIC VALVE REPLACEMENT WITH HOMOGRAFT PROCEDURE, INTERNAL DEFIBRILLATOR PADDLES WORKED TWO TIMES BUT WHEN VOLTAGE WAS INCREASED BY 50 THEY WORKED ONE TIME AND THEN DIDN'T WORK AT ALL. PADDLES CHANGED TWO TIMES. THEN MACHINE CHANGED AND NEW PADDLES DIDN'T WORK. CHANGED TO ORIGINAL PADDLES (ON NEW MACHINE) AND THEY WORKED. THE HEART WAS MASSAGED BY HAND WHILE PADDLES AND DEFIBRILLATOR WERE CHANGED.
DEFIBRILLATOR DID NOT DELIVER ELECTRICAL CURRENT THROUGH THE PADDLES DURING CORONARY ARTERY BYPASS SURGERY. ANOTHER DEFIBRILLATOR HAD TO BE OBTAINED CAUSING A DELAY IN THE RETURN TO AN ACCEPTABLE HEART RHYTHM.
WHEN EKG PAD WAS REMOVED FROM THE PT'S BACK POST-OP, RED-PURPLE BLEMISHES PLUS ONE BLISTERED LESION ON SKIN ALONG EKG BACK PAD WIRING TRACT WERE NOTED. THESE AREAS COINCIDED WITH AREAS ON THE EKG PAD THAT WERE WRINKLED, OR SLIGHTLY BENT.
A SYRINGE CONTAINING NORCURON 10MG IN 10CC SOLUTION WAS REPORTEDLY PLACED ON A SYRINGE PUMP AT A CONTINUOUS RATE OF INFUSION OF 1CC PER HR. APPROX TWO HRS LATER THE SYRINGE PUMP WAS ALLEGEDLY FOUND TO BE EMPTY WITH NO AUDIBLE ALARM SOUNDING. MULTIPLE LIGHTS ON THE CHECK SCREEN AND ZEROS ACROSS THE MAIN SCREEN AND A RED LIGHT AT THE STOP AREA WAS REPORTED BY THE NURSE. NORCURON WAS DISCONTINUED AND BABY APPARENTLY RECOVERED WITHOUT INJURY.
PT HAD A TOTAL HIP REVISION ON 7/28/95. ON 7/29/95 PT EXPERIENCED HIP DISLOCATION. THE SURGEON ALLEGES THAT THE PLASTIC CUP (ACETABULAR LINER SYSTEM) DID NOT SNAP INTO PLACE ON THE PREVIOUSLY IMPLANTED 60MM METAL BACKED CUP AS IT SHOULD HAVE CAUSING WEAKNESS AND FAILURE OF THE HIP REVISION. THE PT RETURNED TO SURGERY 7/29/95 FOR TOTAL HIP REVISION AND REPLACEMENT OF THE ACETABULAR SHELL.
POST DIAGNOSTIC CARDIAC CATH, DECISION WAS MADE TO ANGIOPLASTY AND STENT PROXIMAL CIRCUMFLEX LESION. LESION WAS PREDILATED WITH 2.5/2.0MM CATHETER. A 3.5 CORONARY STENT WAS ATTEMPTED TO BE DEPLOYED, BUT WAS UNABLE TO ADVANCE THRU ACUTE ANGLE OF VESSEL PRIOR TO LESION. CO'S CATHETER WAS REMOVED FORM GUIDING CAHTETER, STENT WAS NOT ON BALLOON. UPON INJECTION OF LCA, PHYSICIAN FELT STENT WAS POSSIBLY IN LEFT MAIN. A 4MM MICROSNARE WAS USED TO RETRIEVE STENT FROM LEFT MAIN, SNARE AND GUIDING CATHETER WAS REMOVED AS A WHOLE UNIT. STENT COULD NOT BE RETRIEVED AND IS PRESUMED TO BE LOST IN THE PERIPHERAL CIRCULATION OF THE LOWER EXTREMITY, PROBABLY THE RIGHT LOWER EXTREMITY.
SYRINGE PUMP ADMINISTED MEDICATION (AMINOPHYLLIN 100MG) AS AN IV BOLUS RATHER THAN AS PROGRAMMED. PUMP WAS REPORTEDLY PROGRAMMED TO DELIVER MEDICATION OVER 20 TO 30 MINS. TACHYCARDIA EPISODE OCCURRED AFTER AMINOPHYLLIN ADMINISTERED WHICH RESOLVED WITHOUT TREATMENT. PUMP WAS EXAMINED BY HOSP BIOMEDICAL ENGINEERING DEPT AND NO PUMP PROBLEMS WERE IDENTIFIED. PUMP WAS PLACED BACK IN SVC. NO ADD'L REPORTS OF PROBLEMS WITH THIS PUMP.
WHILE BEING TRANSFERRED BY LIFT TO BED FROM SHOWER CHAIR. PT SLID OUT OF LIFT. PT'S DAUGHTER AND A STAFF NURSE WERE ASSISTING IN THE TRANSFER. PT FELL TO FLOOR LANDING ON BOTH KNEES AND THEN TO A LYING POSITION ON THE FLOOR.
NEEDLE CAME OFF SUTURE WHILE IN RECTAL WALL WITHOUT TENSION ON SUTURE. REQUIRING TRANSFER TO HOSP FOR INTRA-OP FLUOROSCOPY WHEN NOT ABLE TO BE LOCATED ON MULTIPLE ATTEMPTS.
A 2-0 SUTURE NEEDLE WAS USED ON PT. AT END OF CASE IT WAS NOTICED THAT THE TIP WAS MISSING FROM THE END OF THE NEEDLE. APPROX 1/8" IN LENGTH.
PICC INSERTION COMPLETED WITHOUT DIFFICULTY ADVANCING CATHETER. EXCELLENT BLOOD RETURN. FLUSHED WITH NS AND HEPARIN 100 U/CC, 2.5 CC. UNABLE TO REMOVE GUIDE WIRE. STAT PORTABLE CXR DONE TO CHECK FOR COIL IN LINE OR OTHER REASON FOR STUCK GUIDE WIRE. X-RAY REVEALED NO KINKS OR COILING IN CATHETER. CATHETER WAS REMOVED. GUIDE WIRE PROBLEM WAS NOT RESOLVED NOR COULD GUIDE WIRE BE REMOVED FROM CATHETER EVEN AFTER REMOVAL FROM PT.
SUDDEN DEVELOPMENT OF LARGE AREA OF ECCHYMOSIS ABOVE INSERTION SITE.
ON 1/6/95, A 67-YR-OLD FEMALE, WHO HAD UNDERGONE PRIOR PLACEMENT OF PACEMAKER IN 1989, PRESENTED TO MEDICAL CTR DIAGNOSED WITH SICK SINUS SYNDROME. SHE UNDERWENT SURGERY FOR REMOVAL OF VENTRICULAR LEAD AND PACEMAKER. THE PT WAS DISCHARGED IN STABLE CONDITION.
ON 1/17/95, A 45-YR-OLD FEMALE WHO HAD SOME 13 YEARS PRIOR UNDERGONE BILATERAL SUBPECTORAL AUGMENTATION MAMMOPLASTY, PRESENTED TO MEDICAL CTR'S AMBULATORY SURGICAL FACILITY DIAGNOSED WITH BILATERAL ASYMMETRY (BREAST). SHE UNDERWENT SURGERY FOR REMOVAL OF RIGHT RUPTURED SILICONE BREAST IMPLANT WITH EXTRUDING SILICONE. SHE WAS DISCHARGED IN STABLE CONDITION.
ON 6/17/94, A 29-YR-OLD FEMALE, WHO HAD UNDERGONE BILATERAL AUGMENTATION MAMMOPLASTY SOME YEARS AGO, PRESENTED TO MED CTR'S AMBULATORY SURGICAL FACILITY DIAGNOSED WITH: SUSPECTED RUPTURE OF RIGHT IMPLANT, CAPSULAR CONTRACTURE ON RIGHT, PT DESIRES LARGER. SHE UNDERWENT BILATERAL EXCHANGE OF BREAST IMPLANTS, BOTH IMPLANTS WERE FOUND TO BE RUPTURED, HOWEVER THE COHESIVE SILICONE WAS ABLE TO BE REMOVED. SALINE IMPLANTS WERE PLACED. THE PT WAS DISCHARGED IN STABLE CONDITION.
ON 10/26/94, A 54-YR-OLD MALE WAS ADMITTED FOR REMOVAL OF HIS MALFUNCTIONING VENTRICULAR LEAD AND FOR A PACEMAKER IMPLANT. ON 10/26/94, THE PT UNDERWENT SURGERY FOR: REPLACEMENT OF AICD PULSE GENERATOR. INAPPROPRIATE SHOCKS.
ON 5/11/95, A 61-YR-OLD FEMALE WHO HAD SOME 30 YEARS PRIOR UNDERGONE AUGMENTATION MAMMOPLASTY, PRESENTED TO MEDICAL CTR DIAGNOSED WITH RUPTURED BILATERAL BREAST IMPLANTS. SHE UNDERWENT SURGERY FOR REMOVAL OF BILATERAL RUPTURED SILICONE IMPLANTS. THE PT WAS DISCHARGED IN STABLE CONDITION.
A 71-YR-OLD MALE HAD UNDERGONE AICD PLACEMENT ON 2/95 NOTICED THAT HE WAS OVERSENSING, RECEIVED TWO SHOCKS THAT WERE NOT INDICATED. CARDIOLOGY NOTED EPISODES OF PAUSES 1.9 TO 2.3 SECONDS. ON 9/28/95 PT UNDERWENT REPLACEMENT OF AICD PACEMAKER, REMOVAL OF OLD GENERATOR AND PLACEMENT OF ANOTHER MODEL LEAD WAS REPOSITONED. THE PT SUBSEQUENTLY UNDERWENT REPLACEMENT OF SENSING V-LEAD ON 10/3/95 DUE TO PERSISTENT PAUSES ON TELEMETRY. THE PT TOLERATED THE PROCEDURE WELL AND WAS SUBSEQUENTLY DISCHARGED IN STABLE CONDITION.
PT WAS CODING, ORDERS FOR PT TO BE PACED. MONITOR CONNECTED CORRECTLY. WHEN TURNED ON SCREEN WENT BLANK. INSPECTION OF THE CABLE BY BIOMED ENGINEERING REVEALED A LARGE DEGREE OF SPLIT IN THE FEMALE MOLEX PINS, CAUSING AN OPEN PAD WARNING ON THE MONITOR. UNABLE TO DETERMINE IF MONITOR EFFECTED CODE PROCESS.
THE RPTR DEVELOPED RASHES AND ITCHING AROUND HER FACE, UNDERARMS, AND BACK. SHE ALSO EXPERIENCED A DRY THROAT, COUGHING, AND HER SINUSES FELT TIGHT. SHE FELT BETTER AFTER THE TEMP DROPPED, AND AFTER TAKING MEDICATION.
THE PT HAD AIR BUBBLES THAT WERE CAUSED BY TAKING A HOT "JACUZZI" BATH. THE PT WAS NEVER WARNED NOT TO TAKE A "JACUZZI" BATH. THE RIGHT AND LEFT IMPLANTS ARE DEFORMED WITH LARGE BUBBLES, ESPECIALLY WHEN THE PT LIES DOWN. THE IMPLANTS HAVE SMALL WRINKLES. THE PT VISITED THE PLASTIC SURGEON WHO DID NOT RECOGNIZE THE BUBBLES. THE PT IS NOT SATISFIED AND WANTS TO KNOW IF OTHER PTS HAVE GOTTEN BUBBLES FROM THE HOT WATER. THE PT STATED THAT THE SAME EVENT HAS HAPPENED TO ANOTHER PT.
AFTER THE PT WAS DISCHARGED FROM THE HOSP THE SCREW CAME OUT. FOUR DAYS AFTER THE EVENT THE PT WAS ABLE TO CONTACT THE DR WHO TOLD HER THAT SHE NEEDED A SECOND OPERATION. THE DR WAS WARNED THAT THE SCREW WAS NOT APPROVED BY THE FDA. HOWEVER, HE STILL PUT THE SCREW IN. THE PT WAS IN CONSTANT PAIN. ON A TV SHOW IT WAS REPORTED THAT THE SCREW CAN PARALYZE A PT. THEREFORE THE DR REMOVED THE PT'S SCREW ON 2/2/95. THE PT GOT A SECOND OPINION AND FINALLY THE DR CORRECTED THE PROBLEM. THE PT IS STILL IN PAIN BUT STATED "NOW I CAN WALK." ADD'L IMPLANT DATE 3/23/94.
THE PT RECEIVED PSYCHIATRIC ELECTRIC SHOCK THERAPY IN 1969-70 AT THE HOSP. THERAPY DESTROYED MUCH OF HER MEMORY AND SHE STILL DOES NOT RECALL SOME OF IT. IT WAS FOR TREATMENT OF DEPRESSION, BUT IT DID NOT RELIEVE IT. IN FACT THE DEPRESSION CONTINUED FOR SEVERAL YEARS. SHE IS SUFFERING FROM PERMANENT, IRREVOCABLE MEMORY LOSS AS A RESULT OF ELECTRIC SHOCK THERAPY TREATMENTS.
AFTER REMOVAL OF UMBILICAL ARTERIAL LINE, UNABLE TO CONTROL BLEEDING. TRIED TO SUTURE UMBILICAL ARTERY WHILE CONTROLLING BLEEDING BY MANUAL PRESSURE. WHILE SUTURING, NEEDLE FELL OFF THE SUTURE AND INTO THE ABDOMINAL CAVITY THROUGH UMBILICUS AND UNABLE TO RETRIEVE. A DR WAS CALLED AND RETRIEVED NEEDLE INTACT.
CATHETER PLACED BUT UNABLE TO REMOVE. WIRE BROKE DURING ATTEMPT TO REMOVE 3-4CM. SEGMENT RETRIEVED BY PHYSICIAN. NO KNOWN INJURY TO PT.
PT ADMITTED 3/27/96. PT CONDITION WORSENED OVERNIGHT. DAY OF EVENT, MD AND HUSBAND AT BEDSIDE WHEN PT BECAME BRADYCARDIC, ACLS PROTOCOL INITIATED. RHYTHM CHANGED TO V-TACH FOLLOWED BY V-FIB AT WHICH TIME PT WAS DEFIBRILLATED. BODY DID NOT JERK. ANOTHER UNIT WAS BROUGHT IN AND USED. CODE SUMMARY FROM ORIGINAL DEVICE CONFIRMED NO DEFIB HAD OCCURRED. LATER AFTER REVIEW OF THE CODE, BIOMED CHECK OF DEVICE AND INTERVIEW WITH NURSES IT WAS DETERMINED THAT THE PACER/DEFIB PADS WERE NOT PLUGGED IN TO THE UNIT INITIALLY.
NIBP ON RIGHT ARM AT 2400 ON 3/21/96. 0700 LARGE BRUISE, ECCHYMOSIS BOTH ARMS. NIBP REMOVED. HEMOGLOBIN 3/21/96 10.2 REQUIRED TRANSFUSION, 2 UNITS RBC'S.
PT EXPERIENCED CARDIAC ARREST APPROX 2 1/2 HRS AFTER CT OF CHEST SENT TO HOSP. A DR THERE STATED IT COULD BE AIR EMBOLISM.
PT EXPERIENCED CARDIAC ARREST APPROX 2 1/2 HRS AFTER CT OF CHEST. SENT TO HOSP. A DR THERE STATED IT COULD BE AN AIR EMBOLISM.
THE CHILD ATTEMPTED TO REMOVE THE TRACH FILTER FROM THE TRACH TUBE. THE TRACH FILTER WOULD NOT PULL OFF FROM THE TRACH TUBE AND THEREFORE THE CHILD INADVERTANTLY PULLED OUT THE WHOLE TRACH TUBE.
SINCE 1990, PT HAS HAD RASHES ON HER HANDS, RESPIRATORY DISTRESS WHICH HAD GRADUALLY INCREASED TO THE POINT OF SEVERE RESPIRATORY REACTION. STOPPED USING GLOVES 1/95, BUT CONTINUED TO HAVE RESPIRATORY PROBLEMS WHEN WORKING WITH EMPLOYEES WHO USED THE LATEX GLOVES.
EMPLOYEE USED NORMAL LATEX GLOVES IN A PT ROOM, WITHIN 5 MINS DEVELOPED SYSTEMIC REACTION, REDNESS, ITCHING, TIGHTNESS OF CHEST, WHEEZING, THROAT CLOSING.
HAND RASH DIAGNOSED BY ALLERGIST AS ALLERGIC REACTION.
DIZZINESS, HEAD CONGESTION, THROAT SORE. TESTED FOR AND DIAGNOSED AS SEVERE LATEX ALLERGY.
PT WAS INTUBATED WITH ENDOTRACHEAL TUBE CUFF. DR WAS GOING TO REMOVE NODE FROM RIGHT VOCAL CORD, WHEN USING CO2 LASER IT IMMEDIATELY IGNITED CAUSING BURN TO THE TRACHEA. PT WAS ADMITTED TO ICU FOR FURTHER TREATMENT OF BURN. PT WAS UNABLE TO BE EXTUBATED DUE TO SWELLING.
WHILE TRANSFERRING A RESIDENT, HER RIGHT LEG RECEIVED A SKIN TEAR. THE CALF PADS HAD BEEN LIFTED UP. THE NUTS AND SCREWS PROTRUDED. HER LEG WAS SCRATCHED BY THE PROTRUDING NUTS AND SCREWS. RPTR CALLED THE CO AND THEY ARE RESEARCHING A DIFFERENT TYPE OF NUT TO COVER THE SCREW.
INNER BAG OF PLASTIC CASSETTES LEAK DRUG INTO PLASTIC CONTAINER. RPTR VISUALLY IDENTIFIED ONE LOT # AND 3 OF LOT UNKNOWN.
THE INCIDENT INVOLVED THREE EVENTS: 1. THE FAILURE OF THE SYSTEM TO PROPERLY RECORD A TREATED FIELD ON A RECORD CARD. 2. THE COPYING OF THAT TREATMENT INFO ONTO THE CARD OF ANOTHER PT. 3. THE SUBSEQUENT NON-PRINTING OF 2 RX'S ON THE CARD OF THE SECOND PT. 1. PT 1, A 4 FIELD ABDOMEN, HAD RECEIVED 11 TREATMENTS, ALL PROPERLY RECORDED BY THE SYSTEM. ON 4/9/96 ONLY FIELDS 2,3 & 4 WERE RECORDED ON THE CARD. FIELD 1 WAS MISSING. THE ACCUMULATED DOSE ON THE CARD WAS CORRECT AS WAS THE INFO IN THE PT'S ELECTRONIC FILE AND THE DAILY RECORD. THIS WAS BROUGHT TO THE ATTENTION OF THE MFR'S ENGINEER. NO ERROR CODES WERE GENERATED, HOWEVER, AND NO OTHER PROBLEMS PRESENTED THEMSELVES. 2. ON 4/10/96, ALL 4 FIELDS OF PT 1'S  4/9/96 FIELD 1 WAS RECORDED ON PT 2'S CARD. PT 2'S ACCUMULATED ELECTRONIC FILE DOSE AND DAILY RECORD DATA WERE CORRECT. A TEST CASE WAS RUN TO CHECK THE PRINT PROCESS AND WAS FOUND TO BE OK. THE ENGINEER CHECKED THE HARD DISK AND FOUND NO ERRORS ON THE DRIVE. NO ERRORS PRESENTED FOR ANY OF THE OTHER PTS. THE INCIDENT WAS REPORTED TO MFR'S TECHNICAL ASSISTANCE PEOPLE WHO COULD OFFER NO IMMEDIATE EXPLANATION. 3. ON 4/11/96, PT 1'S CARD CONTINUED TO PRINT CORRECTLY FOLLOWING TREATMENT. AFTER TREATING PT 2, HOWEVER, THE OPERATOR'S SCREEN PROMPTED: BLANK SHEET? INS NEW SHEET PT 2 NAME 2-1.2.1. A NEW CARD WAS PRINTED. ONLY PT 2'S 3RD ELECTRON TREATMENT WAS RECORDED. TREATMENTS 1 AND 2 WERE NOT. THE ACCUMULATED DOSE TOTAL WAS CORRECT. THE ENGINEER ATTEMPTED TO FOLLOW-UP WITH THE MFR'S APPLICATIONS SPECIALIST. 4. ON 4/12/96, TREATMENT #4 WAS CORRECTLY PRINTED FOR PT 2. NO REF WAS MADE BY THE SYSTEM FOR PRINTING TREATMENTS 1 & 2. FOLLOW-UP CONTINUED WITH APPLICATIONS. 5. ON 4/15/96, APPLICATIONS CONFIRMED THAT NO IMMEDIATE EXPLANATION COULD BE GIVEN FOR THE EVENTS DESCRIBED ABOVE. 6. ON 4/16/96, MFR WAS NOTIFIED OF FILING OF FDA REPORT. THE FIELD ENGINEER WILL FILE A FIELD SVC PROBLEM REPORT WITH MFR. CORRECTIVE ACTIONS: PENDING INSTRUCTIONS FROM THE MFR, TECHNOLOGISTS WERE INSTRUCTED TO CAREFULLY MONITOR PRINTOUTS AND REPORT ANY ANOMALIES.
WORKER REMOVED THE NURSE CALL CONNECTOR FROM A PREFABRICATED HEADWALL ASSEMBLY. THE CONNECTOR, A PLUG AND CABLE, ATTACHED TO AN ELECTRIC BED. THE HEADWALL ASSEMBLY ALSO HAS A "DUMMY CONNECTOR" MOUNTED ABOVE THE RECEPTACLE FOR THE BED. THE DUMMY IS USED TO PREVENT FALSE ALARMS ON THE NURSE CALL WHEN THE BED IS UNPLUGGED. THE DUMMY IS CONNECTED TO THE HEAD WALL WITH A METAL CHAIN. AS THE WORKER UNPLUGGED THE BED FROM THE HEAD WALL, THE METAL CHAIN ON THE DUMMY CONNECTOR MADE CONTACT AND CAUSED A SHORT CIRCUIT ACROSS THE 110 VOLT BLADES OF THE BED PLUG.
PUMP PROGRAMMED TO DELIVER 7 ML/HR FOR 12 HRS FOR A TOTAL VOLUME OF 84 ML. PUMP STARTED AT APPROX 8:30 PM. CAREGIVER REPORTED TO NURSE AT 11:00 PM, THAT PUMP ALARMED THAT THE BAG WAS EMPTY. NURSE WENT TO PT'S HOME TO VERIFY THAT THE DOSE WAS DELIVERED IN APPROX 3 HRS. NURSE INITIATED MEASURES TO ENSURE PT'S SAFETY. PUMP WAS BENCH TESTED "IN-HOUSE" AND IT WAS DETERMINED THERE WAS SIGNIFICANT ERROR IN THE PROGRAM VS RATE. RPTR CONTACTED MFR REP. PUMP TAKEN OUT OF SVC AND RETURNED TO MFR ON 3/17/96.
RPTR HAD SEVERE ALLERGIC RESPONSE TO LATEX GLOVES - BRONCHOSPASM/VOMITING/COLLAPSE. RESPONSE WAS TO AEROSOLIZED LATEX, AND GLOVE POWDER. RPTR WAS NOT IN CONTACT WITH LATEX AT TIME OF COLLAPSE.
RPTR SUFFERS FROM BLADDER INCONTINENCE. TO AVOID LEAKAGE WHEN SHE SNEEZES, COUGHS, ETC, SHE NEEDS SOME KIND OF PROTECTION. WHEN SHE SAW A THINNER PAD, SHE DECIDED TO TRY THEM, SINCE THE PANTIE LINERS WERE NOT THICK ENOUGH. MANY TIMES SHE CAME UP WITH VAGINAL IRRITATION EXTENDING TO THE RECTAL SECTION CAUSING DISCOMFORT AND PAIN OUTSIDE AND INTERNALLY. AFTER USING MFR'S BLADDER CONTROL PADS ON AND OFF SHE IS CONVINCED THAT IT WAS THE PADS THAT WERE CAUSING THE PROBLEM REQUIRING MEDICAL ASSISTANCE. SHE WAS EXAMINED BY A DR IN THE HOSP. THE DR TOOK SOME SAMPLES AND TESTS AND PRESCRIBED CREAM TO BE APPLIED INTERNALLY. SHE REPORTED THE PROBLEM TO THE CO AND WAS TOLD THAT SHE MIGHT BE ALLERGIC TO ANY OF THE CHEMICALS THEY USE IN THE PADS.
RPTR HAD TWO BREAST IMPLANTS. SHE HAD HEMORRHAGING IN BOTH BREASTS WITHIN SEVEN DAYS, RELIEVED BY SYRINGE AND CAPSULAR CONTRACTION WITHIN SIX MONTHS. THIS WAS FOLLOWED BY SEVERE HEADACHES, DEPRESSION, HYPERTENSION, LYMPHADENOPATHY, ARTHRITIS, DEGENERATIVE DISC DISEASE, HEART DISEASE, MUSCLE SPASMS, "UNSTABLE" BLADDER, URINARY TRACT INFECTIONS, (CULTURES NEGATIVE), LEFT RENAL STONE, CALCIFIED MESENTERIC NODE, MOUTH LESIONS, HAIR LOSS, IRRITABLE BOWEL SYNDROME, CHRONIC FATIGUE AND SLE (LUPUS).
RPTR THOUGHT SHE HAD A COLD BUT IT WAS LASTING FOR MANY MONTHS. SHE REALIZED THAT WHEN SHE WAS AT HOME SHE WOULD BE FINE. IT PROGRESSED TO WHERE IT CONTINUED OUTSIDE HER WORK PLACE. RPTR EXPERIENCED RASHES ON HER HANDS, CONTINUOUS RUNNY NOSE, AND WATERING EYES.
RPTR HAD 2 BOXES WITH SAME LOT # AND EXP DATE. ONE BOX WAS HALF USED AND THERE WERE NO PROBLEMS. ON 4/10/96 SEVERAL (3) FROM THE ORIGINAL BOX WOULD NOT ABSORB THE SPECIMEN. SO A NEW BOX WITH THE SAME LOT # AND EXP DATE WAS OPENED AND THREE HAD SAME PROBLEM. RPTR OPENED A NEW BOX WITH NEW LOT # AND EXP DATE. RPTR HAD SAME PROBLEM WITH ONE OF 4 USED. OTHER 3 WERE OK.
IN ONE TEST PRODUCT WOULD NOT ABSORB URINE. PRODUCT USED PER POLICY.
TRACHEOSTOMY TUBE FLANGE RIPPED OFF AFTER ONLY THREE DAYS USE.
DURING SURGERY FOR A MAJOR NECK PROCEDURE, A GRAFT WAS TAKEN FROM THE ANTERIOR THIGH. THE SURGEON FELT THAT THE BLADE WAS DIGGING IN TOO DEEP, SO HE PULLED THE HANDPIECE OUT. HE FOUND THAT THE BLADE HAD GOUGED INTO THE DERMALAYERS. THE WIDTH PLATE AND BLADES WERE CHANGED, BUT THE SAME THING HAPPENED. STITCHES AT THE DONOR GRAFT SITE WERE REQUIRED. ALSO USED WITH THE HANDPIECE WERE THE 4" WIDTH PLATE AND 8800-000-10 DERMATOME BLADES.
DURING A LAPAROSCOPY THE PT RECEIVED A BOWEL BURN BY THE PROBE. PT STAYED OVERNIGHT IN THE HOSP FOR OBSERVATION AND HAS BEEN DISCHARGED.
CEMENT DID NOT AFFIX TO THE PATELLA SATISFACTORILY.
FACILITY ALLEGES BLOOD LEAK DURING TREATMENT. NO PT INJURY REPORTED.
METAL BACKED PATELLA WORE OUT AND THE POLY DISASSOCIATED FROM THE METAL BACK, REPLACED WITH ALL POLY PATELLA. TIBIAL TRAY HAD LOOSENED, SO INSERT AND TRAY WERE REMOVED AND REPLACED WITH CRUCIFORM TRAY AND A MEDIUM 13MM REVISION INSERT.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL.
A PT WAS TREATED BASED ON ERRONEOUS RESULTS FROM DEVICE. A VALUE OF 139% AND 180%; BASED ON A "LINEARITY" RANGE OF 0-150%, RESULTS WERE REPORTED. HOWEVER, THE SPECIFIED RANGE FOR DEVICE IS 0-120%; THE FLAGGING RANGE FOR THE UNIT (0-150%) WAS MISTAKEN FOR REAGENT LINEARITY. ALTHOUGH CUSTOMER INITIALLY REFUSED TO RELEASE INFO ON PT CONDITION, THEY LATER ADVISED THE PT DIED.
QUESTECH INTL, INC. STE 238, 4951-B E ADAMO DR, TAMPA, FL 33605. WE RECEIVED PRODUCT RETURNS FROM HSN, BUT NONE THAT COULD BE IDENTIFIED AS MS HAVRANEK'S. THEREFORE, WE HAVE NO TESTING WHICH RELATED TO THE SPECIFIC DEVICE USED BY MS HAVRANEK. THE DEVICE WAS TESTED PER CONSUMER PRODUCT SAFETY COMMISSION REQUIREMENTS FOR PACIFIERS (16 CFR, CH.11 PART 1511), WHICH INCLUDES A STRUCTURAL INTEGRITY TEST FOR THE NIPPLE. IT PASSED TESTS BY AN INDEPENDENT TESTING AGENCY PRIOR TO SUBMISSION FOR OUR FDA 510 (K). SUBSEQUENT TO FDA CLEARANCE TO MARKET, CPSC TOOK INVENTORY FROM OUR TAMPA WAREHOUSE TO TEST IN THEIR OWN LABS. AGAIN, WE PASSED THE NIPPLE PULL TESTS.
ON 4/25/95 PT HAD A HIP OPERATION DUE TO ARTHRITIS AND THE SCREWS WERE USED. HIS WOUND WAS NOT HEALING AND HE WAS IN INTENSE PAIN. HE WENT TO ANOTHER DR AND HAD TO HAVE ANOTHER OPERATION ON 11/9/95. WHEN THEY OPENED HIM, THEY FOUND THE IMMEDIATE AREA NEAR THE SCREWS TO BE INFECTED FROM "CLISTRIDIUM" BACTERIA. THIS WAS EVIDENTLY CAUSED BY EITHER THE DEVICES OR BY DIRTY INSTRUMENTS USED DURING THE OPERATION PREVIOUSLY DONE. THE SECOND DR TOLD HIM THAT, DUE TO THE POSITION OF THE INFECTION IT WAS CAUSED BY THE SCREWS. NOW HE IS TAKING PENICILLIN AND A CLAMP HAS BEEN PUT IN HIS HIP, AND WHEN HE IS HEALED, ANOTHER OPERATION WILL BE DONE TO REMOVE IT.
ON 3/2/96, COMPLAINANT WENT TO THE TANNING SALON AND SET THE TIMER ON THE BED FOR 16 MINS; FIRM PERSONNEL DID NOT ASSIST HER. SHE STATED SHE LOOKED AT HER WATCH BEFORE GETTING INTO THE BED. COMPLAINANT STATED WHEN SHE GOT OUT OF THE BED AND LOOKED AT HER WATCH, 25 MINS HAD ELAPSED. SHE STATED SHE IS "SICK, NOT VOMITING, JUST SICK" AND VERY BURNED. COMPLAINANT STATED SHE TOOK PICTURES OF HERSELF. SUNBED MODEL IS UNKNOWN. COMPLAINANT ALSO STATED BEDS ARE "ALWAYS FILTHY." FACILITY IS IN A GENERAL "STATE OF FILTH - RATS." ETC. SHE STATED SHE SAW HER PHYSICIAN IN A LOCAL RESTAURANT; HE STATED SHE HAD A FIRST DEGREE BURN AND PRESCRIBED SOME LOTION. HOWEVER, SHE CHOSE NOT TO USE THE PRESCRIPTION LOTION. ON 3/4/96, SHE RETURNED TO THE FIRM AND RECEIVED A REFUND. ON 3/18/96, RPTR CONTACTED THE PHYSICIAN'S OFFICE AND REQUESTED THE MEDICAL RECORDS WHICH STATE A DR ORDERED TRIAMCINOLONE SARNA LOTION DUE TO A "VERY RED SWOLLEN RASH ON MOST OF HER BODY. (*)
RIGHT SALINE BREAST IMPLANT LEAK. IMPLANT REMOVED. CRACK FOUND IN CATHETER BETWEEN IMPLANT INJECTION PORT. IMPLANT REPLACED.
THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION AT CO'S FACILITY. A DEVICE HISTORY REVIEW WAS PERFORMED ON THE LOT NUMBER AND SHOWED NO RELATED MFG ISSUES. A COMPLAINT HISTORY REVIEW WAS PERFORMED AND SHOWED ONE OTHER COMPLAINT, FROM THE SAME LOT, FOR SUBCUTANEOUS CATHETER LEAKAGE AND WAS USER-RELATED. THE COMPLAINT RATE FOR THIS DEVICE WAS FOUND TO BE BELOW THE EXPECTED FREQUENCY. THE SEVERITY OF THIS REPORTED OCCURRENCE IS CONSISTENT WITH THAT EXPECTED FOR DEVICES OF THIS TYPE. EXPECTED FREQUENCY: 4.02/YEAR OBSERVED FREQUENCY: 2/YEAR
FLUID WOULD NOT GO THROUGH THE TUBE. RPTR HAS CONTACTED MFR AND MFR HAS REPLACED THE TUBING.
PT ARRIVED AT FACILITY VIA WHEELCHAIR. WHILE BEING TRANSFERRED TO THE DIALYSIS CHAIR USING THE HOYER LIFT THE PT FELL TO THE FLOOR. HEMODIALYSIS TREATMENT INITIATED AT 2:05 PM. CHARGE NURSE INFORMED OF THE PT'S FALL AT 2:10 PM AND DR WAS NOTIFIED. AT 4:50 PM PT BECAME UNRESPONSIVE. EMS CALLED. DR WAS NOTIFIED. PT TRANSFERRED TO MED CTR. PT EXPIRED 3/30/96. FURTHER INVESTIGATION REVEALED THE NET WAS TWISTED UNDER THE PT.
VENOUS ACCESS CATHETER FRACTURE AT ENTRANCE TO SUPERIOR VENA CAVA VIA FLUOROSCOPY. DEVICE IMPLANTED, 1/12/96, AT THE CLINIC. PT SCHEDULED TO FOLLOW UP FOR CATHETER FRACTURE WITH THE CLINIC ON 2/23/96.
S/P LEFT BREAST RECONSTRUCTION WITH IMPLANT. CAPSULAR CONTRACTURE WITH PAIN.
FAILED RIGHT CATH WITH EXTRAVASATION AT THE MIDPOINT OF THE RIGHT SUBCLAVIAN CATHETER.
PT HAD A PORT INSERTED ON 1/26/96. CATHETER WAS TO BE USED FOR CHEMOTHERAPY AND BLOOD ADMINISTRATION. THE PT WAS SEEN ON 2/2 BY RADIOLOGIST WHO HAD INSERTED CATHETER. TWO ADD'L SUTURES PLACED. PT WAS SEEN ON 2/12 BY THE RADIOLOGIST WHO HAD INSERTED CATHETER. TWO ADD'L SUTURES PLACED. A PHONE CALL WAS RECEIVED FROM THE ONCOLOGIST'S OFFICE NURSE STATING THAT SHE BELIEVED THE PORT WAS LEAKING. AFTER EXAMINATION THE PORT WAS REMOVED BECAUSE THE PHYSICIAN FELT THAT THE WOUND WAS NOT HEALING PROPERLY AND THERE WAS A CHANCE OF LEAKAGE. WHEN THE PORT WAS REMOVED THE TISSUE AROUND THE CATHETER APPEARED TO HAVE SCLEROSED.
37-YR-OLD MALE WHO IS STATUS POST-CRANIOTOMY FOR PINEAL TUMOR WITH INSERTION OF VP SHUNT IN 1975, WAS ADMITTED FOR A SHUNT REVISION. THE PT HAS EXPERIENCED SOME DECREASE IN MENTAL CAPACITY AS WELL AS DIFFICULTY AMBULATING OVER THE LAST SEVERAL MONTHS.
50-YR-OLD FEMALE WHO HAS HAD BILATERAL BREAST IMPLANTS SINCE 1978, BEGAN HAVING INCREASING PROBLEMS WITH PAIN AND SWELLING. WHEN THE IMPLANTS WERE REMOVED, THE RIGHT IMPLANT WAS COMPLETELY RUPTURED.
THE NEURO MONITORING TECH HAD 48 INCHES OF ONE OF HER ELECTRODE LEADS BREAK OFF INTO THE PT'S RIGHT POPLITEAL AREA, C-ARM WAS USED. SEARCHED FOR THE ELECTRODE. A SMALL SKIN INCISION WAS MADE, THE NEEDLE ELECTRODE WAS NEVER RECOVERED.
THE DEVICE DID NOT INSTILL PROPER FORMALDEHYDE CONCENTRATION TO DISINFECT THE ARTIFICIAL KIDNEY.
DURING A CRANIAL ARTERIOGRAPHY THAT WAS INITIATED VIA A RIGHT COMMON FEMORAL APPROACH, THE CATHETER GUIDE WIRE PERFORATED WITHIN THE DISTAL AORTA. AS THE CATHETER WAS WITHDRAWN THROUGH THE GROIN, A SMALL PIECE OF THE CATHETER TIP SHEARED OFF AND BECAME LODGED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE LEFT COMMON FEMORAL ARTERY WAS CANNULATED WITH A 7-F SHEATH THROUGH WHICH A GUIDE WIRE AND GUIDING CATHETER WERE ADVANCED TO THE FRAGMENT. A 10-F GOOSE NECK SNARE WAS IMPLEMENTED THROUGH THE GUIDING CATHETER TO RETRIEVE THE FRAGMENT. DURING THE PROCEDURE, HR 46 AND BP 109/44 SUCCESSFULLY TREATED WITH IV FLUID BOLUS AND ATROPINE. PT WILL BE DISCHARGED TO HOME ON 3/13/96 STATUS POST-CAROTID ENDARTERECTOMY.
THIRTY-TWO FR NASAL TRUMPET PLACED IN RIGHT NARE TO FACILITATE SUCTIONING. 3 MINS LATER, THE TRUMPET WAS MISSING. THE TRUMPET WAS FOUND IN THE BACK OF THROAT AND WAS REMOVED IN OR.
AT 1630, PT WAS BREATHING OK ON OXYGEN MASK AND NASAL CANNULA WITH NASAL TRUMPET IN LEFT NARE. AT 1645 NASAL TRUMPET WAS NOTICED MISSING. DEVICE WAS FOUND IN BACK OF THROAT AND REMOVED WITH MCGILL FORCEPS BY THE RESPIRATORY THERAPIST.
SUDDEN COMPLETE FAILURE OF DEVICE NECESSITATING SURGICAL REPLACEMENT.
BROKEN FEMORAL STEM, TOTAL STEM LENGTH = 8 1/4". STEM BROKEN HORIZONTALLY 4 1/2" FROM DISTAL TIP.
A TABLE IN THE CARDIAC CATH LAB LOST POWER WHEN A TRANSFORMER MALFUNCTION OCCURRED. THE BURNED TRANSFORMER WAS LOCATED DIRECTLY UNDER THE PT AND OTHER NEARBY COMPUTER COMPONENTS WERE DAMAGED. THE FIRST LAB ON THE WEST WING HAS BEEN SHUT DOWN PENDING REPAIRS. THE PT WAS UNDERGOING A PERMANENT PACEMAKER IMPLANT AT THE TIME OF THE EVENT AND HAD TO BE TRANSPORTED TO THE OR FOR COMPLETION OF THE PROCEDURE. NO INJURIES WERE REPORTED.
BEDRAIL WITH SPRING LOADED BARS THAT ATTACH TO THE BED WERE TO WIDE FOR THE BED. A LARGE SPACE BETWEEN THE SIDE RAILS AND THE MATRESS EXIST, WHEN THE BEDRAIL IS NOT PUT IN LOWER POSITION. EVEN IN THE LOWER POSITION THERE IS A SMALL GAP. A RESIDENT TRIED TO GET OUT OF BED VIA THE GAP. STAFF ASSISTED RESIDENT TO FLOOR.
DR DRILLED 7 HOLES IN CRANIUM WITHOUT PROBLEM. AT 8TH HOLE, PERFORATOR DIDN'T STOP WHEN IT WENT THRU BONE. WENT INTO SAGGITAL SINUS CAUSING BLEEDING. PERFORATOR WAS STUCK AND WOULD NOT BACK OUT OF CRANIUM AS IT SHOULD. AFTER MANY ATTEMPTS DR FINALLY GOT THE PERFORATOR OUT AND HAD TO SUTURE THE SUPERIOR SAGGITAL SINUS TO CONTROL BLEEDING, ADDING 45 MINS TO SURGERY.
PCA PUMP WITH 50 MG OF DILAUDID WAS INFUSING INTO PT'S CATHETER. AFTER DIALYSIS WAS STARTED, THE PRESSURE IN THE VENOUS LINE CAUSED THE SYRINGE TO PULL OUT OF THE SAFETY LOCK. THE ENTIRE CONTENTS OF THE SYRINGE WAS DRAWN INTO THE PT. BP WENT DOWN TO 55/32. THE PT HAD RECEIVED AN OVERDOSE OF DILAUDID. THE PT WAS GIVEN 3 AMPULES OF NARCAN. BP ROSE TO 98. AFTER DIALYSIS WAS COMPLETE, THE PT WAS TRANSFERRED TO ICU. NARCAN DRIP WAS GIVEN FOR 6-7 HRS UNTIL SHE METABOLIZED THE DILAUDID. ONCE STABILIZED SHE WAS TRANSFERRED OUT OF ICU (LATER THE SAME DAY). PT WAS DISCHARGED ON 3/7 AFTER OTHER MEDICAL PROBLEMS WERE STABILIZED.
PT RECEIVING INOTROPIC DRUGS VIA INFUSION PUMP. A 3-WAY STOPCOCK IN-LINE DEVELOPED A LEAK (CAUSE UNKNOWN) ALLOWING ALL OR A SIGNIFICANT PORTION OF THE INTENDED INFUSION TO LEAK OUT. THE INTERRUPTION OF DRUG DELIVERY TO THE PT RESULTED IN SEVERE HYPOTENSION. CARDIOPULMONARY INTERVENTION WAS NECESSARY.
DURING A TREATMENT ON A PT, THEY FAILED TO RINSE THE HEMOFILTER ACCORDING TO INSTRUCTIONS, AND AS A RESULT, THE PT'S BLOOD CAME IN CONTACT WITH GLYCERINE. DIURETICS AND BLOOD PRODUCTS WERE ADMINISTERED TO PT TO ALLEVIATE THE PROBLEM.
DR COMPLETED PROCEDURE AND PLACED LIGHT CORD ON PT DRAPE. LIGHT TURNED OFF BY NURSE. ON REMOVAL OF DRAPE A 1 1/2 CM (DIME SIZE) BLISTER WAS NOTED. THERE WAS A BURN NOTED IN DRAPE AT THIS TIME.
SURGICAL TABLE WENT INTO FULL SIDE TILT WHEN UNATTENDED, AND COULD NOT BE RESET. THIS COULD OCCUR DURING SURGERY OR WHILE PT ON TABLE. IT WAS NOTED THAT THE TABLE HAND CONTROL WAS LYING ON THE FLOOR AND, SINCE THERE WAS CLEANING WATER ON THE FLOOR, SOME MIGHT HAVE GOTTEN INTO THE CONTROLS. PLASTIC CASE WAS CRACKED AND THERE WAS CORROSION ON THE CONTROLLER CIRCUIT BOARD BETWEEN PINS PL1-12 AND P1-13.
INSTRUMENT USED TO PLACE LIGAMENT GRAFT IN FOSSA IN ACL REPAIR. FOUND ONE TINE MISSING AFTER CASE FINISHED. X-RAY SHOWED METAL TINE IN JOINT BUT NOT FREE FLOATING.
PT RECEIVING HYPERALIMENTATION FEEDING. FILTER ON TUBING HAD COME APART "ON THE SEAL." HYPERALIMENTATION STOPPED UNTIL NEW SOLUTION AND TUBING COULD BE PLACED (ANOTHER SOLUTION WAS HUNG). HAD A DIFFERENT SOLUTION BEEN RUNNING IN, THE PT COULD HAVE HAD SOME SERIOUS PROBLEMS. IN THIS CASE, PT SUFFERED NO ILL EFFECTS DUE TO TIMING OF NURSE'S OBSERVATION.
BLUE INTRODUCER DETACHED FROM PEG TUBE DURING INSERTION WITH NORMAL TRACTION, LEAVING END OF PEG IN ABDOMEN. PEG RETRIEVED THROUGH MOUTH.
BLUE INTRODUCER DETACHED FROM PEG TUBE DURING INSERTION WITH NORMAL TRACTION. GRASPED END OF PEG WHICH WAS LEFT IN ABDOMEN WITH HEMOSTAT PER PHYSICIAN AND PULLED TO CORRECT POSITON.
PRODUCT CRACKED WHEN SYRINGE WAS CONNECTED AND CHEMO WAS BEING RECONSTITUTED. SPRAYED CHEMO OUT.
THREE OF 6 UNITS (IMPLANTS) APPEARED TO BE DEFECTIVE AT THE TIME OF REMOVAL FROM THE STERILE PACKAGING PRIOR TO INSERTION INTO THE PT'S EYE. PORTIONS OF THE IMPLANTS SEEMED TO ADHERE TO THE PACKAGING. OTHER DEFECTS OR LACK OF UNIFORMITY OF THE IMPLANT SURFACE WERE VISUALIZED UNDER THE SURGICAL MICROSCOPE.
PT ADMITTED 12/29/95 FOR FRACTURED FEMUR. MFR'S STANDARD BARREL, 135-DEGREE, 6-HOLE PLATE WAS INSERTED. PT PROGRESSED WELL AND WAS DISCHARGED. ADMITTED ON 3/23/96 FOR REFRACTURE OF FEMUR THROUGH PROXIMAL SCREW HOLE OF 6-HOLE, 135 DEGREE NAIL PLATE.
THE MONITOR WAS NOT BEING CLEANED PROPERLY AT THE FACILITY. IT WAS BEING CLEANED ACCORDING TO MFR'S INSTRUCTIONS IN INSTRUCTION BOOKLET, TO CLEAN WITH WATER AND WIPE WITH A SOFT CLOTH. THE ONLY LABEL ON THE MONITOR SAYS NOT TO USE ALCOHOL. THE LABELING IS NOT ADEQUATE FOR CLEANING A DEVICE WHERE BLOOD SPILLING WOULD BE EXPECTED. THE FACILITY NOTIFIED THE MFR AND MFR SAID TO USE A WEAK BLEACH SOLUTION. RPTR HAS NO KNOWLEDGE OF OTHER USERS RECEIVING INSTRUCTIONS TO CLEAN PROPERLY.
FROM 1992 TO 1995, RPTR HAD WORSENING ALLERGIC REACTIONS. HER HANDS USED TO ITCH WHEN SHE WORE LATEX GLOVES. THEN SHE HAD SINUS PROBLEMS, RUNNY NOSE, EYE IRRITATIONS, STRANGE RASHES ON HER FACE AND NECK, AND FINALLY SHE STARTED HAVING BREATHING PROBLEMS. SHE MADE TRIPS TO EMPLOYEE HEALTH AND IT WASN'T UNTIL SHE HAD DIFFICULTY BREATHING THAT THEY TESTED FOR LATEX ALLERGY. PREVIOUSLY THEY GAVE HER BENADRYL. SHE NOW WEARS AN ALERT BRACELET. SHE MAY ALSO BE ALLERGIC TO PENICILLIN, DEMEROL AND ASPIRIN. (ALSO SEE 1008951).
FROM 1992 TO 1995, RPTR HAD WORSENING ALLERGIC REACTIONS. HER HANDS USED TO ITCH WHEN SHE WORE LATEX GLOVES. THEN SHE HAD SINUS PROBLEMS, RUNNY NOSE, EYE IRRITATIONS, STRANGE RASHES ON HER FACE AND NECK, AND FINALLY SHE STARTED HAVING BREATHING PROBLEMS. SHE MADE TRIPS TO EMPLOYEE HEALTH AND IT WASN'T UNTIL SHE HAD DIFFICULTY BREATHING THAT THEY TESTED FOR LATEX ALLERGY. PREVIOUSLY THEY GAVE HER BENADRYL. SHE NOW WEARS AN ALERT BRACELET. SHE MAY ALSO BE ALLERGIC TO PENICILLIN, DEMEROL AND ASPIRIN. (ALSO SEE 1008950).
RPTR HAS BEEN EXPERIENCING DIZZINESS, VERTIGO AND BLURRING VISION FOR THE PAST TWO MONTHS. VARIOUS DOCTORS HAVEN'T BEEN ABLE TO DIAGNOSE THE PROBLEM. SHE FEELS THAT THESE SYMPTOMS MIGHT BE RELATED TO HER IMPLANTS, ALONG WITH SEVERAL OTHER SYMPTOMS THAT HAVE PRESENTED ON AND OFF FOR THE PAST SEVERAL YEARS. THESE INCLUDED ITCHING, EASY BRUISING, HEADACHES, FATIGUE, HAIR LOSS.
IMPLANTS CAUSED PAIN FROM TIME THEY WERE INSERTED. DR WOULD DO CLOSED CAPSULOTOMY EVERY TIMES SHE WENT TO HIM BECAUSE BREASTS WOULD BE HARD AND EXTREMELY SORE. HE KEPT TELLING HER THAT IT WAS HER FAULT FOR NOT MASSAGING BREASTS ENOUGH. SHE WAS MASSAGING TEN MINS OUT OF EVERY HR BECAUSE THAT WAS ONLY WAY SHE COULD KEEP PAIN DOWN. 6/88 SHE HAD PAINFUL, SWOLLEN RIGHT THUMB. TREATED WITH MOTRIN FOR 3 MONTHS. THUMB INJECTED WITH CORTISONE AND EVENTUALLY RETURNED TO NORMAL. LATER IN JUNE SHE HAD A HERPES INFECTION ON LOWER LIP. SINCE THEN SHE HAS HAD HERPES SORES ABOUT EVERY 6 MONTHS. 5/89 RPTR HAD PAIN IN RIGHT RIB CAGE, THOUGHT TO BE DUE TO INFLAMMED NERVE. CHRONIC PAIN CONTINUES TO THIS DAY. 12/89 SEVERE PAIN IN RIGHT RIB CAGE AND DOWN RIGHT ARM. USED TENS UNIT FOR 3 WEEKS AND PAIN DOWN ARM SUBSIDED. PRIMARY CARE DR WOULD NOT REFER HER TO PLASTIC SURGEON AND SAID ALL HER PAIN WAS JUST ARTHRITIS. RASH FROM WRISTS TO MIDDLE OF CHEST AND FROM GROIN TO KNEES BECAME VERY NOTICEABLE IN 2/91 BUT DR IGNORED IT. REMAINS AND IS NOW ALL THE WAY TO HER ANKLES. 1/92 SAW NEW DR WHO IMMEDIATELY COULD SEE HOW MUCH PAIN SHE WAS HAVING AND THAT HER BREASTS WERE HARD AS ROCKS AND CONSTRICTED. DR REFERRED HER TO PLASTIC SURGEON. 2/92 IMPLANTS REMOVED ALONG WITH CAPSULE. NERVE BLOCK DONE IN SURGERY SO SHE WAS PAIN-FREE FOR ABOUT 3 MONTHS. PATHOLOGY REPORT SHOWED SILICONE IN CAPSULAR TISSUE. 5/92 SEVERE DIARRHEA-DIAGNOSED AS GASTROENTERITIS THEN AS DIVERTICULITIS AND EVENTUALLY AS SALMONELLA. 9/92 BLOOD IN URINE. 12/92 ULTRASOUND SHOWED BENIGN CYST ON LOWER POLE LEFT KIDNEY. 1/93 OCG SHOWED GALLSTONES. SURGEON WAS NOT CONVINCED GALLSTONES WERE PROBLEM SO DID UGI AND BAE. UGI SHOWED SILICONE IN GALLBLADDER TISSUE. 6/93 SIGMOIDOSCOPY SHOWED MULTIPLE DIVERTICULA WITH MUSCULAR HYPERTROPHY AND SOME NARROWING OF SIGMOID COLON. 10/93 LEFT KNEE SWOLLEN AND PAINFUL. 1/94 DIFFICULTY IN SWALLOWING, CONSTANT REGURGITATION ON BURPING, AND PAIN IN RIB CAGE. 1995 HAD TWO ORAL LESIONS (DIFFERENT TIMES). 6/95 URINGE CYTOLOGY POSITIVE FOR MALIGNANT CELLS SO MRI WAS DONE AND BLADDER BIOPSY WHICH WAS INCONCLUSIVE, POSSIBLE LOW GRADE CANCER BUT NO DEFINITE CANCER CELLS. RPTR HAS NOT HAD ONE COMFORTABLE DAY SINCE IMPLANTS WERE PLACED IN HER BODY. REMOVAL OF THEM DID NOT TAKE CARE OF THE PROBLEMS. (*)
IV TUBING HUNG WITH IV BAG ON PT. NURSE NOTICED IV WAS "DRIPPING ON THE FLOOR." THE REASON FOR THE "DRIP" WAS THAT THE IV TUBING HAD PULLED OUT OF THE SLEEVE WHICH FASTENS THE TUBING TO THE IV CATHETER.
PT REMOVED THE PCN 6 MU IN A 100 ML/HR PUMP FROM THE REFRIGERATOR RIGHT BEFORE INFUSION. SINCE THE MEDICATION WAS COLD, PT CALLED THE RN FOR DIRECTIONS TO WARM UP THE PCN. AS PER RN DIRECTIONS, THE PT PLACED THE PCN PUMP INTO THE MICROWAVE WHICH RESULTED IN EXPLOSION OF THE PUMP. (*)
ON EXAMINATION (UPON NURSING REACCESS VISIT), NEEDLE WAS FOUND SEPARATED FROM MAIN HOUSING (BUTTERFLY AND TUBING). NEEDLE BROKE AT 90 DEGREE ANGLE, LEAVING PART OF NEEDLE PROTRUDING FROM PORT, THEREFORE INTERRUPTING CHEMOTHERAPY INFUSION. NURSE PULLED REMAINDER OF NEEDLE OUT AND PLACED NEW NEEDLE. FLUSHING WAS SLUGGISH SO UROKINASE HAD TO BE ADMINISTERED, THEN CHEMO RESTARTED. (REQUIRED EXTRA NURSING VISIT).
34 CC BALLOON WAS INSERTED DURING SURGERY WHEN THE PT HAD DIFFICULTY COMING OFF BYPASS. THE PHYSICIAN HAD DIFFICULTY INSERTING THE BALLOON DUE TO THE PT'S SIZE AND ANATOMY. AN ATTEMPT WAS MADE TO INSERT THE BALLOON IN THE RIGHT FEMORAL ARTERY BUT WAS UNSUCCESSFUL. THE BALLOON WAS INSERTED IN THE LEFT FEMORAL ARTERY WITH DIFFICULTY. AFTER 30 HRS OF PUMPING, THE CONSOLE ALARMED KINKED LINE," AND BLOOD SPECS WERE NOTED IN THE EXTRACORPOREAL TUBING. THE BALLOON WAS TURNED OFF AND DISCONTINUED. ALSO AT THAT TIME THE PT HAD LOST PULSES IN BOTH FEET, AND BOTH FEET WERE CYANOTIC. AFTER THE BALLOON WAS REMOVED, THE PT WENT BACK TO SURGERY FOR EMERGENT BILATERAL FEMORAL BYPASSES.
A 34 CC INTRA-AORTIC BALLOON WAS INSERTED SHEATHLESS IN SURGERY WHEN THE PT WAS HAVING DIFFICULTY COMING OFF BYPASS. IMMEDIATELY AFTER INSERTION, BLOOD WAS NOTED IN THE EXTRACORPOREAL TUBING INDICATIVE OF A LEAK. THE BALLOON WAS IMMEDIATELY DISCONTINUED AND A 40 CC BALLOON WAS INSERTED. THE PHYSICIAN FELT IT MAY HAVE TORN UPON SHEATHLESS INSERTION.
A 40 CC INTRA-AORTIC BALLOON WAS INSERTED WITHOUT INCIDENT. FOLLOWING INSERTION THE PUMP CONSOLE ALARMED AND BLOOD WAS NOTED IN THE TUBING. THE BALLOON WAS IMMEDIATELY DISCONTINUED, AND A 34 CC BALLOON WAS INSERTED.
PRODUCT DOES NOT LIST IT'S CONTENTS WHICH ARE SWALLOWED WITH FOOD AT MEALS. THEY HOLD DENTAL PLATED WHEN FIRST APPLIED. VERY LITTLE REMAINS AT END OF THE DAY. RPTR ASKS CAN THE "GLUE" CONTENTS BE A HEALTH HAZARD AND ISN'T IT ILLEGAL NOT TO LIST CONTENTS. (ALSO SEE 1008961).
PRODUCT DOES NOT LIST IT'S CONTENTS WHICH ARE SWALLOWED WITH FOOD AT MEALS. THEY HOLD DENTAL PLATED WHEN FIRST APPLIED. VERY LITTLE REMAINS AT END OF THE DAY. RPTR ASKS CAN THE "GLUE" CONTENTS BE A HEALTH HAZARD AND ISN'T IT ILLEGAL NOT TO LIST CONTENTS. (ALSO SEE 1008960).
THE COMPLAINT WAS INVESTIGATED AND THE PRODUCT WAS EVALUATED AND NO MDR REPORT IS REQUIRED.
RPTR RECEIVED A LETTERSIZED ENVELOPE FROM MFR. A PLAIN UNWRAPPED LATEX GLOVE WAS INSIDE THE FOLDED FLYER. WHEN SHE OPENED IT UP, THE GLOVE FELL OUT. FOR MOST PEOPLE, THIS OF COURSE IS NOT A PROBLEM BUT RPTR IS EXTREMELY ALLERGIC SUCH THAT SHE WEARS A MEDIC ALERT BRACELET. RPTR CALLED THE CO AND SPOKE TO A CO OFFICIAL WHO MADE SMART REMARKS WHEN SHE TOLD HIM HE SHOULD SEND THE PRODUCT SEALED IN SOMETHING SUCH AS A PLASTIC BAG. INDEED, ALTHOUGH HE STATED HE KNEW ABOUT LATEX ALLERGY, HE IN NO WAY WAS CONCERNED ABOUT THE VERY REAL RISK TO RPTR (OR ANYONE ELSE, SHE SUPPOSES).
PT HAD INTRA-AORTIC BALLOON PUMP INSERTED ON 3/5/96. ON 3/12/96, STAFF OBSERVED BLOOD IN CATHETER TUBING AND PUMP WAS REGISTERING A LEAK. THE PUMP WAS SHUT DOWN AND THE BALLOON WAS REMOVED. THE PT EXPIRED ON 3/15/96.
THE PT WAS UNCONSCIOUS, UNRESPONSIVE WITH DECREASED RESPIRATIONS AND AN UNDETECTABLE PULSE. THE DEFIBRILLATOR PADS WERE PLACED IN THE PROPER POSITION AND THE DEFIBRILLATOR CABLES WERE ATTACHED TO THE PADS. THE CALL RECORDING MODULE WAS INSERTED AND THE DEFIBRILLATOR WAS TURNED ON. THE RHYTHM WAS OBSERVED AND INTERPRETED AS VENTRICULAR FIBRILLATION; BUT ALSO IT WAS NOTED THE "CHECK ELECTRODES" MESSAGE WAS BEING DISPLAYED ON THE SCREEN, EVEN THOUGH THERE WAS NO AUDIO INDICATION FROM THE DEFIBRILLATOR. OPERATOR CLOSED THE LID TO SHUT THE UNIT OFF AND OPENED IT AGAIN TO RESTART IT WITH THE SAME RESULTS AS THE FIRST TIME. THE DEFIBRILATOR CABLES, PADS, AND CONNECTIONS WERE PHYSICALLY AND VISUALLY CHECKED WITH NO DEFICITS FOUND. AFTER CHECKING TO SEE IF EVERYTHING WAS PROPER A SECOND TIME, OPERATOR SUSPECTED THAT THERE WAS SOMETHING WRONG WITH THE DEFIBRILLATOR AND REPLACED THE BATTERY WITH THE BACKUP BATTERY WITH THE SAME RESULTS AS BEFORE. ANOTHER DEFIBRILLATOR WAS ATTACHED TO THE PADS ALREADY ON THE PT'S CHEST WITH THE SAME RESULTS AS BEFORE. THE DEFIBRILLATOR PADS WERE THEN REPLACED AND THE SECOND DEFIBRILATOR WAS ATTACHED TO THEM AND THE CALL RECORDING MODULE WAS INSERTED INTO THE DEFIBRILLATOR. THE "PRESS TO ANALYZE" MESSAGE WAS DISPLAYED AND THE ANALYZE FUNCTION WAS ACTIVATED BY PRESSING THE BUTTON INDICATED BY THE DISPLAY ON THE SCREEN. THE UNIT STARTED TO CHARGE TO 200 JOULES. THE SHOCK WAS ADMINISTERED AND THE ANALYZE FUNCTION WAS AGAIN ACTIVATED. THIS TIME THE "NO SHOCK INDICATED" MESSAGE WAS DISPLAYED AND CPR WAS CONTINUED. BOTH CALL RECORDING MODULES WERE DOWNLOADED AT THE HOSP. BUT ONLY THE SECOND PRINTED THE INFO, THE FIRST HAD NO INFO ON IT. INITIALLY THE PT'S ECG WAS UNABLE TO BE ANALYZED BY THE DEFIBRILLATOR BECAUSE THE "CHECK ELECTRODES" MESSAGE BEING DISPLAYED. THIS DOES NOT ALLOW THE "PRESS TO ANALYZE" MESSAGE TO APPEAR ON THE SCREEN. WHICH IN TURN DOES NOT ALLOW THE ACTIVATION OF THE ANALYZE MODE OF THE DEFIBRILLATOR. THEREFORE ANY DEFIBRILLATION ATTEMPT CAN NOT BE ACCOMPLISHED WITHOUT THE DEFIBRILLATOR ANALYZING AND DETERMINING A SHOCKABLE RHYTHM WHICH WILL ACTIVATE THE CHARGING SEQUENCE. COMPLAINANT SAID THE UNIT IS CHECKED AT THE BEGINNING OF EACH SHIFT PER THE MFR'S INSTRUCTIONS. THE PADS IN USE DURING THE INCIDENT WERE MFR'S DEFIB ELECTRODES. EXP DATE 1/16/97. THEY HAVE NOT HAD ANY PREVIOUS PROBLEMS WITH THE UNIT. THE DEFIBRILLATOR WAS RETURNED TO MFR FOR EVALUATION. THE PADS REMAIN UNDER LOCK AND KEY. RPTR QUESTIONED WHY THE PADS WERE NOT RETURNED, SINCE YOU COULD SUSPECT THE PADS WERE DEFECTIVE AND CAUSED/CONTRIBUTED TO THE FAILURE. COMPLAINANT CLAIMED HE WOULD HOLD ON TO THEM PENDING A POSSIBLE LAW SUIT BY THE VICTIM'S FAMILY.
RESIDENT LIFTED FROM BED VIA LIFT AND TRANSFERRED TO CHAIR SCALE FOR WEIGHING. LIFT AGAIN USED TO TRANSFER RESIDENT AFTER WEIGHT OBTAINED FROM CHAIR SCALE BACK TO BED. AFTER LIFT RAISED RESIDENT FROM CHAIR, THE NURSE'S AIDE PUMPED THE LIFT TO RAISE THE RESIDENT HIGHER, TO RETURN TO BED. THE LIFT IMMEDIATELY DROPPED CAUSING RESIDENT TO BE DROPPED TO THE FLOOR (HYDRAULIC PUMP FAILURE).
THREE REGISTERED NURSES HAVE INCURRED A NEEDLE STICK WHILE SLIDING SAFETY SHEATH UP AFTER GIVING AN IMMUNIZATION. THIS HAS OCCURRED IN THE SAME SMALL DEPT OVER AN 18-MONTH PERIOD. THEY FEEL THAT THE SHEATH WAS STICKING OR IN SOME OTHER WAY HARD TO SLIDE. ALL THREE INCIDENTS OCCURRED DURING IMMUNIZATION CLINICS. FOLLOWING EXPOSURES, RPTR'S BODY SUBSTANCE EXPOSURE PROTOCOL WAS FOLLOWED AND THE EMPLOYEES HAVE ON-GOING FOLLOW UP IN THE OCCUPATIONAL HEALTH CLINIC. THESE NURSES FELT THERE COULD BE SOME DESIGN IMPROVEMENT SUCH AS A LIP TO PREVENT THE HAND FROM SLIPPING OFF THE SAFETY SHEATH.
APPROX 5 YEARS AFTER HAVING BREAST IMPLANTS, RPTR STARTED HAVING JOINT PROBLEMS. SHE TESTED POSITIVE FOR RHEUMATOID ARTHRITIS. BECAUSE OF MANY OTHER HEALTH PROBLEMS,SUCH AS SCLERODERMA, ASTHMA, HEADACHES AND DEBILITATION, SHE DECIDED TO UNDERGO EXPLANTATION OF BREAST IMPLANTS.
PAC IMPLANTED 1/16/95. MOTHER AND NURSING STAFF UNABLE TO ACCESS PORT (NO BLOOD RETURN). UROKINASE WAS ADMINISTERED - THERE WAS SOME SWELLING AROUND THE PORT AND THE CHILD COMPLAINED OF PAIN. CHEST X-RAY WAS DONE TO CHECK LINE PLACEMENT. PORT WAS NOTED TO HAVE A BREAK IN THE TUBING. THIS BREAK WAS NEAR THE JUNCTION OF THE CATHETER AND THE LEFT SUBCLAVIAN VEIN. THE PROXIMAL, INTACT, SEGMENT WAS LOCATED IN THE SUPERIOR VENA CAVA AND THE FRACTURED. DISTAL SEGMENT, (APPROX 14 CM IN LENGTH) HAD ABOUT ONE HALF (7CM) ACROSS THE TRICUSPID VALVE WITH THE TIP IN THE RIGHT VENTRICLE. HEART CATH LAB REMOVED THE BROKEN PIECE THROUGH THE FEMORAL VEIN. PT WAS OBSERVED OVERNIGHT AND DISCHARGED HOME WITH NO KNOWN COMPLICATIONS.
CO2 ACTIVATED STAPLER GUN FAILED TO EJECT AND STAPLE ON ROUNDS 3 & 4 OF 4 STAPLES. THIS OCCURRED REPEATEDLY WITH TWO DIFFERENT LOT NUMBERS. AS A CONSEQUENCE, SURGERY WAS DELAYED UP TO ONE HR AND MANUAL STAPLES WERE NEEDED TO COMPLETE THE PROCEDURE WITH THE LUNG. AS THE EQUIPMENT "PINCHED" WITHOUT "STAPLING" SOME FRIABLE LUNG TISSUE WAS TORN.
PT TRANSFERRED AS AN EMERGENCY WITH PERICARDIAL TAMPONADE FOR EMERGENCY SURGERY BY CV SURGEON. PT HAD HAD LEAD IN PLACE FOR APPROX 2-3 YEARS. THERE HAD BEEN A CLASS I RECALL ON THIS LEAD BY THE MFR AND PT WAS CAREFULLY MONITORED BY ATTENDING PHYSICIAN IN NEIGHBORING TOWN. INJURY TO PT - SMALL PUNCTURE SITE IN THE RIGHT ATRIUM AT JUNCTION OF SUPERIOR VENA CAVA AND RIGHT ATRIUM LEADING TO PERICARDIAL TAMPONADE AND LARGE PERICARDIAL EFFUSION. GENERATOR WAS EXPLANTED ALTHOUGH IT WAS FUNCTIONING NORMALLY, VENTRICULAR LEAD WAS NOT REMOVED (AMPUTATED). PT HAD BEEN STABLE PRIOR TO THIS EPISODE BUT IN CRITICAL CONDITION UPON ADMISSION. PT SURVIVED PROCEDURE WELL AND WAS DISCHARGED HOME ON 3/22/96. (AS OF THIS REPORT DATE THE CV SURGEON REPORTS PT CONTINUES TO DO WELL).
DURING SURGICAL PROCEDURE A HAND CONTROL CAUTERY WAS USED TO COAGULATE BLEEDERS ON THE EYELID, WHEN BUTTON COMPRESSED, A FLAME FLASHED ACROSS THE EYELID APPROX 2 INCHES BURNING OFF ALMOST ALL OF THE EYELASHES. PT RECEIVING 6 LITERS OF O2 AT THE TIME, O2 REDUCED TO 2 L. PROCEDURE CONTINUED WITH NO FURTHER PROBLEMS, BUT EQUIPMENT WAS REMOVED FROM SVC AND SENT TO BIOMED FOR EVALUATION. EQUIPMENT UNDER WARRANTY AND RETURNED TO CO FOR EVALUATION ON 2/21/96.
THE RECANALIZATION GUIDE WIRE COULD NOT BE MADE TO CROSS A CHRONICALLY OCCLUDED LAD LESION USING BALLOON AND WIRE TECHNIQUE. AS THE WIRE WAS REMOVED, THE WIRE FRACTURED AND SEPARATED IN THE AORTA LEAVING APPROX 10CM IN THE ASCENDING AORTA WHILE REMAINING LODGED IN THE LAD. ATTEMPTS TO RETRIEVE THE WIRE WITH A CATHETER AND SNARE WERE NOT SUCCESSFUL. CORONARY ARTERY BYPASS SURGERY WAS PERFORMED TO EXTRAXT THE WIRE FRAGMENT AND TO BYPASS HIS LAD AND "CIRCUMFERENCE" CORONARY VESSELS. THE WIRE WAS EXTRACTED UNEVENTFULLY.
51-YR-OLD MALE WITH DIAGNOSIS: SCIZOAFFECTIVE DISORDER, MANIC PSYCHOSIS. PT RESTRAINED IN BED BY VEST RESTRAINTS. NURSES FOUND PT WITH HEAD WEDGED BETWEEN RAIL AND MATTRESS WITH VEST RESTRAINT AROUND NECK. PT UNRESPONSIVE WITH PULSE BUT NO RESPIRATIONS. MOUTH TO MOUTH INITIATED; RESULTING IN SPONTANEOUS RESPIRATIONS. THIS MAY HAVE BEEN A DELIBERATE ATTEMPT BY PT TO COMMIT SUICIDE.
51-YR-OLD MALE WITH DIAGNOSIS: SCHIZOAFFECTIVE DISORDER, MANIC PSYCHOSIS. PT RESTRAINED IN BED BY VEST RESTRAINTS. NURSES FOUND PT WITH HEAD WEDGED BETWEEN RAIL AND MATTRESS WITH VEST RESTRAINT AROUND NECK. PT UNRESPONSIVE WITH PULSE BUT NO RESPIRATIONS. MOUTH TO MOUTH INITIATED; RESULTING IN SPONTANEOUS RESPIRATIONS. THIS MAY HAVE BEEN A DELIBERATE ATTEMPT BY PT TO COMMIT SUICIDE.
THE TRACHEOSTOMY TUBE, IN THE INTUBATED PT, DEFLATED WHEN HE WAS TURNED ON HIS SIDE DUE TO HIS LARGE BODY MASS. ATTEMPTS TO REINFLATE THE BALLOON WERE UNSUCCESSFUL. THE TUBE WAS REMOVED AND A NEW ONE PUT IN. INSPECTION OF PREVIOUS TUBE FOUND A HOLE IN BALLOON.
ATTEMPTED INSERTION OF CATHETER INTO LEFT MEDIAN CUBITAL VEIN. UPON INSERTION 3", PT COMPLAINED OF TROUBLE BREATHING. O2 ON AT 5 L. HEAD OF BED ELEVATED. SHE COMPLAINED OF CHEST PAIN AND BECAME CYANOTIC. PHYSICIAN CALLED STAT AND CATHETER WAS REMOVED. BENADRYL ADMINISTERED IV. COLOR IMPROVED. PT'S CONDITION RETURNED TO BASELINE WITHIN 1/2 HR. SHE WAS DISCHARGED THE FOLLOWING DAY TO CONTINUE PLANNED THERAPY FOR HER ADMITTING CONDITION WITH NO LASTING EFFECTS FROM THIS INCIDENT.
ON 3/15/96 AFTER AN EMERGENCY DIAGNOSTIC CATHETERIZATION, THE DECISION WAS MADE TO PROCEED WITH PTCA OF THE LAD ARTERY DUE TO PERSISTENT CHEST PAIN AND ST SEGMENT ELEVATION. WHEN THE GUIDE WIRE WAS BEING REMOVED, THE GUIDE WIRE BROKE AND THE CORE REMAINED IN THE DISTAL VESSEL. RETRIEVAL ATTEMPTS WERE UNSUCCESSFUL. ON 3/18/96, THE PT UNDERWENT SURGERY TO REMOVE THE REMAINING WIRE FRAGMENT. (*)
METALLIC TIP OF FEEDING TUBE BROKE OFF, APPARENTLY PERFORATING THE COLON REQUIRING SURGICAL INTERVENTION FOR REMOVAL.
PT HAD A TOTAL HIP PROCEDURE DONE 9/21/95. PROCEDURE HAD TO BE REPEATED DUE TO A BROKEN DEVICE RING.
PT WAS UNDERGOING LAPAROSCOPY, WHEN TROCAR WAS INSERTED AND TWISTED, THE TOP BROKE AWAY FROM THE SHAFT. IT WAS RETRIEVED WITH A KELLY CLAMP. NO UNTOWARD EFFECT TO PT.
UNDERGOING SURGERY FOR CAD ON 3/13/96. AT END OF CASE, COULD NOT OBTAIN CARDIAC OUTPUTS. MONITOR READ "CATHETER DEFAULT." CATHETER REPLACED. RETURNED GOODS.
IABP CATHETER RUPTURED AND BLOOD BACKED UP INTO THE CATHETER.
IABP CATHETER RUPTURED AND BLOOD BACKED UP INTO CATHETER
BILATERAL BREAST PROSTHESIS REMOVED BECAUSE OF SEVERE CONTRACTURES.
BREAST RECONSTRUCTION FOR BREAST CANCER DONE IN 1991. REMOVED BECAUSE OF GRADE 4 CAPSULAR CONTRACTURE.
LEFT BREAST IMPLANT REMOVED BECAUSE IT RUPTURED. RIGHT ALSO REMOVED.
BREAST IMPLANTS INSERTED IN 1992. REMOVED BECAUSE OF CAPSULAR CONTRACTURE AND SUBSEQUENT RUPTURE.
BREAST IMPLANTS PLACED 23 YEARS AGO. REMOVED BECAUSE OF CONTRACTURES AND RUPTURE OF THE RIGHT IMPLANT.
ADDITIONAL INFO RECEIVED FROM MFR ON 07/02/1996: AS A RESULT OF THE TESING AND EVALUATION PERFORMED, DISETRONIC MEDICAL SYSTEMS HAS CONCLUDED THAT THE ORIGINAL AND MODIFIED DEVICES DO NOT PRESENT ANY RISK OF INJURY AND ARE NOT IN ANY WAY TO BE CONSIDERED HEALTH HAZARDS. THE ALLEGATION PRESENTED IN THE ADVERSE EVENT REPORT IS THE RESULT OF UNPROFESSIONAL AND UNRELIABLE TESTING AND MISREPRESENTATIONS, OMISSIONS AND MODIFICATIONS OF THE AVAILABLE INFORMATION.
PT HAD MALFUNCTIONING CATHETER PER CHEST X-RAY. THE TIP OF THE CATHETER WAS BROKEN. THE CATHETER WAS RETRIEVED BY THE RADIOLOGIST ON 2/13/96.
A RELOADABLE 90MM LINEAR STAPLER WAS OPENED AND USED. STAPLES DIDN'T FORM PROPERLY. RESECTED THE AREA OF ANASTOMOSIS IN WHICH THE STAPLES DID NOT FORM AND COMPLETED RESECTION WITH A DIFFERENT ROTICOLATOR INSTRUMENT. ANASTOMOSIS HAD TO BE TAKEN DOWN AND THEN REANASTOMOSED. THIS ADDED ADD'L HR TO PROCEDURE.
THE CAP ON THE FEMALE END OF THE 7 INCH EXTENSION SET HAS BEEN DIFFICULT TO REMOVE ALMOST AS IF THEY ARE GLUED ON.
RPTR HAD BILATERAL BREAST IMPLANTS AFTER BEING BURNED IN 6/77. IN THE LAST 4-5 YEARS RPTR HAD CONTINUOUS PROBLEMS IN THE AREAS OF JOINT PAIN AND SWELLING, UNUSUAL AND UNEXPLAINED FATIGUE, SWOLLEN HANDS AND FEET, AND ONE IMPLANT HAS BECOME ALMOST TOTALLY CALCIFIED AND FEELS ROCK HARD.
Y116Y4/4/964/4/96NI192418631379Y4/4/96NIY4/4/96DENTAL IMPLANT FAILED TO OSSEOINTEGRATE.
DENTAL IMPLANT FAILED TO MAINTAIN OSSEOINTEGRATION.
DENTAL IMPLANT FAILED TO OSSEOINTEGRATE.                         DENTAL IMPLANT FAILED TO OSSEOINTEGRATE.
ECMO PUMP STOPPED FUNCTIONING AFTER "SNAPPING" SOUND HEARD. MANUAL CRANKING WAS REQUIRED WHILE THE PUMP WAS CHANGED. SPLIT BELT CONFIRMED BY BIOMEDICAL ENGINEERING. SECOND SUCH INCIDENT OF BELT BREAKAGE SINCE 1/96. PT'S O2 SATURATION DECREASED, BUT RETURNED TO BASELINE QUICKLY AFTER GOING BACK ON ECMO. ABG'S DURING HAND CRANKING 28/47/72/24. ALL APPROPRIATE PREVENTIVE MAINTENANCE HAD BEEN DONE ON PUMP. BELT WITH NORMAL USAGE TIME, SO SHOULD NOT HAVE SPLIT. RECEIVED NO RECOMMENDATION OR REPORT OF EVALUATION ON PREVIOUS INCIDENT REPORTED 1/96.
INSERTED 3FR CATHETER AND, UPON REMOVAL, ONLY ONE HALF OF THE GUIDE WIRE CAME BACK OUT. WIRE HAD TO BE REMOVED UNDER FLUOROSCOPY. (*)
IOL WOULD NOT UNFOLD AFTER PLACEMENT IN THE EYE. IOL WAS WARMED PRIOR TO INSERTION.
CONDUCTING A ROUTINE THERAPEUTIC PHLEBOTOMY ON PT, WHEN THE FLOW OF BLOOD BEGAN TO SLOW DOWN SUDDENLY. IMMEDIATELY CHECKED FOR POSSIBLE CAUSES AND FOUND THE BLOOD COLLECTION TUBING TO BE FLATTENING (OR COLLAPSING). ALSO OBSERVED A CRIMPED AREA WHERE THE CLAMP HAD BEEN CLOSED. TRIED EVERY TECHNIQUE KNOWN TO GET BLOOD TO FLOW BUT COULD NOT SET IT      . RPTR WAS FORCED TO RESTICK PT IN ANOTHER VEIN TO FINISH PHLEBOTOMY. TUBING WORKED ON SECOND ATTEMPT BUT RAN VERY SLOWLY. PT HAS BEEN TREATED AT RPTR'S FACILITY OVER 50 TIMES BEFORE FOR SAME PROCEDURE USING A DIFFERENT BRAND OF TUBING.
INSERTED AN 18G CATHETER INTO LEFT BASILIC VEIN. PROCEDURE TOOK 35 MINS. FLOW WAS SLUGGISH AND TUBING COLLAPSED. HAD TO MANIPULATE TUBING; THEREFORE, IV WAS MANIPULATED CAUSING PT GREAT DISCOMFORT. IV CLOTTED BEFORE TREATMENT WAS COMPLETED. HAD TO RESTICK PT. ON LAST ADMISSION 3/16/96 AN 18 GAUGE ANGIOCATH INSERTED INTO THE SAME VEIN WITHOUT DIFFICULTY. OBTAINED 500ML'S OF BLOOD IN 12 MINS.
PT WITH KNOWN LATEX ALLERGY WAS TO RECEIVE AMPICILLIN VIA NON-LATEX ELASOTOMERIC PUMP. PUMP (MFG BEFORE 1993) WAS USED. PT DEVELOPED ITCHING IN THE EYE, RASH AND WHEEZING. ORAL BENADRYL GIVEN.
AFTER EXPOSURE TO LATEX GLOVES, EYE (USUALLY LEFT). LATER BOTH EYES AFFECTED. PT FELT LIKE A FOREIGN OBJECT WAS IN HER EYE. THEN SHE HAD SEVERE ITCHING AND DRAMATIC SWELLING WHICH FINALLY SUBSIDED DAYS LATER WITH BENADRYL. EVENTS WORSENED UNTIL RETIREMENT 6/94, ENDED DAILY EXPOSURE. RPTR HAD NERVE CONDUCTION TEST. HAD WHEALS ON ARM AT EACH CONTACT POINT WITH DOCTORS GLOVES 3/96. (ALSO SEE 1008993).
RPTR HAD BREAST IMPLANTS PLACED 9/18/95. 9/24/92 DOCTOR'S VISIT FOR HAIR LOSS, MOUTH SORES, SWOLLEN LYMPH NODES AND FATIGUE. OFTEN SICK. 6/4/93 IMPLANTS REMOVED AFTER DISCOVERY OF RIGHT SIDE RUPTURE. LEFT LYMPH NODE BIOPSY SHOWED FOREIGN BODY GIANT CELL RESPONSE AND SILICONE. IMPLANTS REPLACED WITH SALINE IMPLANTS. FROM ONSET OF PROBLEMS, OTHER SYMPTOMS DEVELOPED. FLU-LIKE FEELING, BURNING CHEST, ACHING JOINTS, RAYNAUD'S. MUSCLE ACHES, MEMORY LOSS, NUMBNESS AND LOSS OF STRENGTH IN ARMS. MYALGIA, RASH ON FACE, DRY EYES, LIPS AND NOSTRILS BLEEDING. 2/18/94 SALINE IMPLANTS REMOVED. RIGHT LYMPH NODE BIOPSY SHOWED GRANULOMAS. 9/94 BELLS PALSY (LEFT SIDE), HEADACHES, NAUSEA, BLURRED VISION AND DIGESTIVE PROBLEMS. SOME SYMPTOMS HAVE IMPROVED. MANY EXIST TO DATE.
MAMMARY IMPLANTS REMOVED DUE TO POSSIBLE RUPTURE.
WHILE TPN RUNNING, PT'S HUSBAND NOTICED THE TUBING ON THE NEEDLE 20G, 3/4" WAS SPLIT. RPTR STATES BELOW CONNECTOR SITE, TUBING WAS CRACKED AND SPLIT. PT DENIES FORCING ANYTHING INTO SITE OR HITTING CONNECTOR. PT'S HUSBAND ATTEMPTED TO FLUSH SITE AFTER NOTICING CRACK. SALINE WENT ALL OVER THE PLACE. NURSE WAS CALLED, SHE REACCESSED PT WITHOUT DIFFICULTY.
THE END OF TEH MALE-MALE EXTENSION SET WHICH GOES TO THE PT. BROKE OFF, SO COULDN'T USE THE CASSETTE OF MSO4 UNTIL A NEW PART WAS SENT OUT TO PT'S HOME.
PLEASE FIND ATTACHED MEDWATCH FORMS WITH ACCESS NUMBERS 1008976, 1008977, AND 1008978. THE DEVICE(S), NOTED ON THESE FORMS AS THE BRAND: "TAYLOR MCGHAN SILASTIC IMPLANT", WERE NOT MFG BY CO.
RPTR WAS SPITTING SUTURES, SHE HAD INTRAORAL BLEEDING AND HAD TO CLEAN WITH PEROXIDE SOLUTION. AS TIME PROGRESSED, SHE HAD CHIN PAIN AND TENDERNESS (MORE ON THE RIGHT SIDE). SHE ALSO EXPERIENCED A TINGLING SENSATION IN HER FACE AND EXTREMITIES, COLD HANDS AND FEET, DRY EYES AND MOUTH, SIGNIFICANT WEIGHT LOSS, AND ANTERIOR AND POSTERIOR CERVICAL AND BILATERAL AXILLARY AND INGUINAL LYMPHADENOPATHY. SHE HAD A BLOOD TEST AND SHE FOUND OUT THAT SHE HAD SILICONE INTRABODIES; "BIG EYE"; IMMUNE DISREGULATION, MECHANISM DISORDERS THAT CAUSED HER TO HAVE SILICONE MATERIAL. AUTOIMMUNE DISEASE, AND THYROID PROBLEMS. THE SALIVARY GLANDS HAD FOREIGN BODY GIANT CELL GRANULATION TISSUE DESTRUCTION FROM THE SILICONE IN ALL 3 LOCATIONS (RIGHT, LEFT, AND CHIN). HER IMMUNE SYSTEM IS "GUARDED" (WILL BE LIKE THIS FOR THE REST OR HER LIFE). SHE IS ALLERGIC TO SYNTHETIC MATERIALS SUCH AS SILICONE AND PLASTIC. SHE HAD ROLLER LIP IMCOMPETENCE AND PTOSIS TO THE DEGREE WHERE SHE IS UNABLE TO CLOSE HER MOUTH AND TOUCH HER UPPER AND LOWER LIPS TOGETHER WITHOUT SEVERE PAIN. SHE HAS PROBLEMS EATING, TALKING (PRONOUNCING WORDS) AND SHE IS VERY SENSITIVE TO HOT AND COLD WHERE THE IMPLANT ANGLES ARE LOCATED. ON 3/93 SHE HAD A SOFT TISSUE GENIOPLASTY. HER PAIN GOT WORSE AND SHE WAS HAVING PROBLEMS SUCH AS CHRONIC FATIGUE, MEMORY PROBLEMS AND VISUAL DISTURBANCES, DISORIENTATION AND PROBLEMS WITH COGNITIVE FUNCTIONS.  (ALSO SEE 1008976, 1008978)
RPTR WAS SPITTING SUTURES, SHE HAD INTRAORAL BLEEDING AND HAD TO CLEAN WITH PEROXIDE SOLUTION. AS TIME PROGRESSED, SHE HAD CHIN PAIN AND TENDERNESS (MORE ON THE RIGHT SIDE). SHE ALSO EXPERIENCED A TINGLING SENSATION IN HER FACE AND EXTREMITIES, COLD HANDS AND FEET, DRY EYES AND MOUTH, SIGNIFICANT WEIGHT LOSS, AND ANTERIOR AND POSTERIOR CERVICAL AND BILATERAL AXILLARY AND INGUINAL LYMPHADENOPATHY. SHE HAD A BLOOD TEST AND SHE FOUND OUT THAT SHE HAD SILICONE INTRABODIES; "BIG EYE"; IMMUNE DISREGULATION, MECHANISM DISORDERS THAT CAUSED HER TO HAVE SILICONE MATERIAL. AUTOIMMUNE DISEASE, AND THYROID PROBLEMS. THE SALIVARY GLANDS HAD FOREIGN BODY GIANT CELL GRANULATION TISSUE DESTRUCTION FROM THE SILICONE IN ALL 3 LOCATIONS (RIGHT, LEFT, AND CHIN). HER IMMUNE SYSTEM IS "GUARDED" (WILL BE LIKE THIS FOR THE REST OR HER LIFE). SHE IS ALLERGIC TO SYNTHETIC MATERIALS SUCH AS SILICONE AND PLASTIC. SHE HAD ROLLER LIP IMCOMPETENCE AND PTOSIS TO THE DEGREE WHERE SHE IS UNABLE TO CLOSE HER MOUTH AND TOUCH HER UPPER AND LOWER LIPS TOGETHER WITHOUT SEVERE PAIN. SHE HAS PROBLEMS EATING, TALKING (PRONOUNCING WORDS) AND SHE IS VERY SENSITIVE TO HOT AND COLD WHERE THE IMPLANT ANGLES ARE LOCATED. ON 3/93 SHE HAD A SOFT TISSUE GENIOPLASTY. HER PAIN GOT WORSE AND SHE WAS HAVING PROBLEMS SUCH AS CHRONIC FATIGUE, MEMORY PROBLEMS AND VISUAL DISTURBANCES, DISORIENTATION AND PROBLEMS WITH COGNITIVE FUNCTIONS.  (ALSO SEE 1008976, 1008977)
PT DEVELOPED A SEVERE PAIN, HEADACHES AND DECREASED MOTION. PT DEVELOPED ALLERGIES TO THE DEVICE MATERIALS. PT HAD BONE DISTRACTION AND FOREIGN BODY REACTIONS. SHE HAD A BONE SCAN AND SPECT SCAN WITH RADIOACTIVE DYE INJECTED TO CHECK FOR INCREASED ACTIVITY. THE RESULTS SHOWED THAT SHE HAD MARKEDLY INCREASED JOINT ACTIVITY IN THE TMJ REGION (THE RIGHT SIDE GREATER THAN THE LEFT). IT WAS ALSO FOUND THAT SHE HAD A BONE FRAGMENT IN THE GLENOID FOSSA AREA ON THE RIGHT TMJ. SHE HAD SURGERY ON 7/30/94 AND HAD BILATERAL TMJ ARTHROPLASTY AND IT WAS FOUND THAT SHE HAD FOREIGN BODY DEBRIDEMENT OF THE TMJ JOINTS. THEY HAD TO REMOVE THE RIGHT TMJ AND REPLACE IT WITH A NEW ONE. (ALSO SEE 1008980 - 1008984).
PT DEVELOPED A SEVERE PAIN, HEADACHES AND DECREASED MOTION. PT DEVELOPED ALLERGIES TO THE DEVICE MATERIALS. PT HAD BONE DISTRACTION AND FOREIGN BODY REACTIONS. SHE HAD A BONE SCAN AND SPECT SCAN WITH RADIOACTIVE DYE INTECTED TO CHECK FOR INCREASED ACTIVITY. THE RESULTS SHOWED THAT SHE HAD MARKEDLY INCREASED JOINT ACTIVITY IN THE TMJ REGION (THE RIGHT SIDE GREATER THAN THE LEFT). IT WAS ALSO FOUND THAT SHE HAD A BONE FRAGMENT IN THE GLENOID FOSSA AREA ON THE RIGHT TMJ. SHE HAD SURGERY ON 7/30/94 AND HAD BILATERAL TMJ ARTHROPLASTY AND IT WAS FOUND THAT SHE HAD FOREIGN BODY DEBRIDEMENT OF THE TMJ JOINTS. THEY HAD TO REMOVE THE RIGHT TMJ AND REPLACE IT WITH A NEW ONE. (ALSO SEE 1008979 & 1008981 - 1008984).
PT DEVELOPED A SEVERE PAIN, HEADACHES AND DECREASED MOTION. PT DEVELOPED ALLERGIES TO THE DEVICE MATERIALS. PT HAD BONE DISTRACTION AND FOREIGN BODY REACTIONS. SHE HAD A BONE SCAN AND SPECT SCAN WITH RADIOACTIVE DYE INJECTED TO CHECK FOR INCREASED ACTIVITY. THE RESULTS SHOWED THAT SHE HAD MARKEDLY INCREASED JOINT ACTIVITY IN THE TMJ REGION (THE RIGHT SIDE GREATER THAN THE LEFT). IT WAS ALSO FOUND THAT SHE HAD A BONE FRAGMENT IN THE GLENOID FOSSA AREA ON THE RIGHT TMJ. SHE HAD SURGERY ON 7/30/94 AND HAD BILATERAL TMJ ARTHROPLASTY AND IT WAS FOUND THAT SHE HAD FOREIGN BODY DEBRIDEMENT OF THE TMJ JOINTS. THEY HAD TO REMOVE THE RIGHT TMJ AND REPLACE IT WITH A NEW ONE. (ALSO SEE 1008979, 1008980 & 1008982 - 1008984).
PT DEVELOPED A SEVERE PAIN, HEADACHES AND DECREASED MOTION. PT DEVELOPED ALLERGIES TO THE DEVICE MATERIALS. PT HAD BONE DISTRACTION AND FOREIGN BODY REACTIONS. SHE HAD A BONE SCAN AND SPECT SCAN WITH RADIOACTIVE DYE INJECTED TO CHECK FOR INCREASED ACTIVITY. THE RESULTS SHOWED THAT SHE HAD MARKEDLY INCREASED JOINT ACTIVITY IN THE TMJ REGION (THE RIGHT SIDE GREATER THAN THE LEFT). IT WAS ALSO FOUND THAT SHE HAD A BONE FRAGMENT IN THE GLENOID FOSSA AREA ON THE RIGHT TMJ. SHE HAD SURGERY ON 7/30/94 AND HAD BILATERAL TMJ ARTHROPLASTY AND IT WAS FOUND THAT SHE HAD FOREIGN BODY DEBRIDEMENT OF THE TMJ JOINTS. THEY HAD TO REMOVE THE RIGHT TMJ AND REPLACE IT WITH A NEW ONE. EXPLANT DATE 7/30/96. (ALSO SEE 1008979 - 1008981, 1008983, 1008984).
PT DEVELOPED A SEVERE PAIN, HEADACHES AND DECREASED MOTION. PT DEVELOPED ALLERGIES TO THE DEVICE MATERIALS. PT HAD BONE DISTRACTION AND FOREIGN BODY REACTIONS. SHE HAD A BONE SCAN AND SPECT SCAN WITH RADIOACTIVE DYE INJECTED TO CHECK FOR INCREASED ACTIVITY. THE RESULTS SHOWED THAT SHE HAD MARKEDLY INCREASED JOINT ACTIVITY IN THE TMJ REGION (THE RIGHT SIDE GREATER THAN THE LEFT). IT WAS ALSO FOUND THAT SHE HAD A BONE FRAGMENT IN THE GLENOID FOSSA AREA ON THE RIGHT TMJ. SHE HAD SURGERY ON 7/30/94 AND HAD BILATERAL TMJ ARTHROPLASTY AND IT WAS FOUND THAT SHE HAD FOREIGN BODY DEBRIDEMENT OF THE TMJ JOINTS. THEY HAD TO REMOVE THE RIGHT TMJ AND REPLACE IT WITH A NEW ONE. (ALSO SEE 1008979 - 1008982, 1008984).
PT DEVELOPED A SEVERE PAIN, HEADACHES AND DECREASED MOTION. PT DEVELOPED ALLERGIES TO THE DEVICE MATERIALS. PT HAD BONE DISTRACTION AND FOREIGN BODY REACTIONS. SHE HAD A BONE SCAN AND SPECT SCAN WITH RADIOACTIVE DYE INJECTED TO CHECK FOR INCREASED ACTIVITY. THE RESULTS SHOWED THAT SHE HAD MARKEDLY INCREASED JOINT ACTIVITY IN THE TMJ REGION (THE RIGHT SIDE GREATER THAN THE LEFT). IT WAS ALSO FOUND THAT SHE HAD A BONE FRAGMENT IN THE GLENOID FOSSA AREA ON THE RIGHT TMJ. SHE HAD SURGERY ON 7/30/94 AND HAD BILATERAL TMJ ARTHROPLASTY AND IT WAS FOUND THAT SHE HAD FOREIGN BODY DEBRIDEMENT OF THE TMJ JOINTS. THEY HAD TO REMOVE THE RIGHT TMJ AND REPLACE IT WITH A NEW ONE. (ALSO SEE 1008979 - 1008983).
RPTR DEVELOPED A METALLIC REACTION TO THE MATERIAL.
NURSING PERSONNEL DISCOVERED EXTENSION TUBE FROM WALL OXYGEN CONNECTED TO IV PORT. RESUSCITATION ATTEMPTED. PT DIED. RPTR SUGGESTS COLOR CODING OF OXYGEN AND IV TUBING AND THAT THEY BE MADE INCOMPATIBLE IN SIZE. (ALSO SEE 4001159).
NURSING PERSONNEL DISCOVERED EXTENSION TUBE FROM WALL OXYGEN CONNECTED TO IV PORT. RESUSCITATION ATTEMPTED. PT DIED. RPTR SUGGESTS COLOR CODING OF OXYGEN AND IV TUBING AND THAT THEY BE MADE INCOMPATIBLE IN SIZE. (ALSO SEE 4001158).
A HEAVY PT WAS MANEUVERING HERSELF ONTO THE TABLE OVER THE MYLAR INSERT SECTION. THE WHOLE MYLAR SECTION SHIFTED DURING THIS MANEUVERING AND FELL BETWEEN THE TWO TABLE TOP RAILS, ALONG WITH THE PT. THE MYLAR SECTION AND THE PT FELL ON THE FILM HOLDER, WHICH BROKE. THIS IS THE SECOND INCIDENT OF THIS KIND. THE FEET OF THE TABLE INSERT HAVE BEEN MODIFIED (EXTENDED) TO PREVENT FURTHER INCIDENTS.
PUMP WOULD NOT DELIVER BOLUS DOSE NOR REGISTER ATTEMPTS. (CONTINUOUS MODE AND CLINICIAN BOLUS WORKED APPROPRIATELY).
ONE OF THE THREE WHITE PLASTIC SPIKES WAS DISCOVERED MISSING FROM THE TUBING SET THAT CONNECTS TO THE BAG. WITHOUT THIS SPIKE THE TUBING WAS EXPOSED TO OUTSIDE AIR, COMPROMISING THE CLOSED SEAL WITHIN THE BAG. THE BAG WAS NOT USED. FURTHER INSPECTION OF BAGS FROM SIMILAR LOTS REVEALED NO OTHER DEFECTS.
HUB OF PICC LINE AND APPROX 1-2 INCHES OF CATHETER FOUND BESIDE PT IN THE MIDDLE OF THE NIGHT. WIFE WAS UNSURE IF REST OF CATHETER WAS STILL IN PT'S ARM OR IF "THE DOGS ATE IT." MD WAS NOTIFIED. PT SENT TO HOSP FOR FLUOROSCOPY. LINE WAS FOUND LODGED IN UPPER ARM. IT WAS REMOVED VIA CUTDOWN PROCEDURE BY MD.
ACCORDING TO CORRESPONDENCE FORWARDED BY RPTR, COMPLAINANTS' MEDICS  COMPLAIN ALMOST DAILY IN REGARD TO THE AMOUNT OF ARTIFACT THEY ARE SEEING. MOST RECENTLY THEY HAVE HAD TWO CPR SITUATIONS THAT BATTERIES HAVE GONE DEAD, AND MEDICS HAD TO TAKE THE TIME TO REPLACE THEM. COMPLAINANT IS RECEIVING COMPLAINTS FROM PERSONNEL WHO FEEL THAT THEY ARE ASSUMING A GREAT DEAL OF LIABILITY, USING EQUIPMENT THEY KNOW IS DIFFICULT TO WORK WITH. PERSONNEL C/O A PROBLEM WITH THE ECG SIZE BUTTON. WHEN IT IS PUSHED THE RESPONSES ARE INAPPROPRIATE. RPTR ALSO FORWARDED CORRESPONDENCE INDICATING MFR'S RESPONSE TO THEIR COMPLAINTS HAS BEEN INADEQUATE. (*)
RPTR HAD THREE VENTRICULO-PERITONEAL BRAIN SHUNTS IMPLANTED BETWEEN 10/92 AND 2/93. HIS MOST IMPORTANT FINDING INVOLVES A SAFETY RISK WITH MFR'S SHUNTS IN THAT VERY SLIGHT EXTERNAL PRESSURE APPLIED TO IT WILL CAUSE SIGNIFICANTLY DECREASED CSF FLOW, I.E. DURING SLEEP. IT IS RPTR'S BELIEF THAT IT'S PROPENSITY TO DO THIS WAS KNOWN, YET THE CO (TO HIS KNOWLEDGE) HAS NOT CONDUCTED ANY STUDIES OR DISCLOSED ANY WARNINGS. HE PRESENTLY HAS A SPECIAL PERFORMANCE SHUNT, THOUGHT TO BE VERY VULNERABLE TO EXTERNAL SCALP PRESSURES, TO WHICH MFR DID NOT OBTAIN A 510(K) APPROVAL. IT MAY HAVE BEEN USED INCORRECTLY AFTER THE INITIAL SHUNT FAILURE. HE IS ABLE TO CORRELATE INCREASED HEADACHE AND PRESSURE SYMPTOMS IN THE AM AFTER SLEEPING ON HIS SHUNTED SIDE. HE ALSO SUFFERS SOME INCREASED CSF PRESSURES WHEN ON HIS FEET, NOT UNCOMMON WITH THIS VALVE. ON 10/1/92, RPTR HAD THE FIRST SHUNT PLACED WITH A CSF FLOW CONTROL VALVE. HE BECAME VERY ILL THE NEXT AM AND WAS BED-RIDDEN UNTIL THE SHUNT WAS REPLACED ON 10/7/92, WITH ANOTHER VALVE. THE DR REPORTED TO HIM AND HIS FAMILY THAT THE SHUNT VALVE HAD FAILED FOR SOME UNKNOWN REASON. DURING HIS SIX DAYS OF BEING BED-RIDDEN, HE LOST 15 LBS, AND WAS MEDICATED AROUND THE CLOCK. HE WAS ILL ALSO WHEN LYING DOWN. THIS EVENT WAS SO SEVERE, IT CAUSED HIS MRI BRAIN SCAN TO SHOW EVIDENCE OF INJURY FROM EXCESSIVE CSF DRAINAGE. THE SHUNT PLACED ON 10/7/92, CAUSED A WORSENING OF HIS HYDROCEPHALUS SWELLING, AND WAS REVISED WITH A SPECIAL PERFORMANCE VALVE ON 2/16/93. BUT THIS BROUGHT MARGINAL RELIEF, WITH SOME DECREASE IN VENTRICLE SIZE ON BRAIN SCAN. HIS CONDITION SEEMED TO DETERIORATE WITH SECONDARY CARDIAC AND VISUAL DIFFICULTIES. THE PERITONEAL CATHETER WAS FOUND OCCLUDED AND WAS REVISED IN 1/26/94. THE 10/7/92 OPERATIVE REPORT SAYS THE INITIAL VALVE HAD "0" CLOSING PRESSURE. BUT, BETWEEN THE PRE-OP AND POST-OP DIAGNOSIS THE FINDING WAS NEVER MENTIONED, AND OVERSHUNTING REMAINED AS THE DIAGNOSIS. HE WAS TOLD BY A FIELD REP AT THE RECENT HYDROCEPHALUS CONFERENCE, THAT THIS FINDING IS VERY SUGGESTIVE OF A VALVE PROBLEM, AND THAT THE 2ND VALVE SHOULD NOT HAVE BEEN USED AS A CORRECTIVE MEASURE. (*) 10/92 - PRESENT.
PT HAD A CARDIAC ARREST IN THE OR AT THE COMPLETION OF PLACEMENT OF THE PLASMA APHERESIS CATHETER. SHE WAS UNABLE TO BE RESUSCITATED AND EXPIRED. THE AUTOPSY REVEALED A SMALL PERFORATION OF THE CORONARY SINUS WITH HEMOPERICARDIUM WHICH MAY HAVE BEEN FROM THE CATHETER GUIDE WIRE OR TIP.
DURING PLACEMENT THE CATHETER PULLED APART LEAVING APPROX 9 CMS IN THE INFANT'S UMBILICAL ARTERY. RETRIEVAL WAS NOT POSSIBLE; INFANT TRANSFERRED TO HOSP. THAT FACILITY REPORTED PT'S DEATH THROUGH RISK MGMT/QUALITY OFFICE. EXTERNAL PART OF DEVICE SENT TO MFR.
PT WAS FOUND BY STAFF WITH UPPER TORSO OUT OF BED BETWEEN BEDRAIL AND HEAD OF BED. LOWER TORSO WAS IN BED WITH BUTTOCKS UP AND KNEES NEXT TO BEDRAIL, BEDRAILS WERE UP AND IMPROPER POSITION. WAIST RESTRAINT WAS PROPERLY APPLIED AND IN PLACE (TO WAIST AREA) AND BOTH SIDES TIED TO BED FRAME. ARMS WERE HANGING DOWN AND TOUCHING FLOOR. HEAD WAS IN TRASH CAN. PT HAD NO VISIBLE SIGNS OF LIFE.
PT DIALYZED WITHOUT INCIDENT UNTIL LAST 5-10 MINS WHEN DIALYZER CLOTTED. TREATMENT WAS DISCONTINUED AND PT DISCHARGED TO NSG HOME. SHE WAS LATER SENT TO THE HOSP WHERE HEMOLYSIS WAS IDENTIFIED. PT DIED ON 3/7/96.
PT WAS FOUND BY 11-7 NURSE, WEDGED PARTIALLY BETWEEN SIDERAIL AND DEFLATED AIR MATTRESS.
THIRTY-TWO MINS INTO THE HEMODIALYSIS TREATMENT, THE PT EXPERIENCED HYPOTENSION AND A BRIEF SEIZURE EPISODE. PT DOES HAVE A HISTORY OF SEIZURES. A 200CC BOLUS OF NORMAL SALINE CORRECTED THE HYPOTENSION. THE SEIZURE EPISODE WAS SELF-LIMITED. THE PT DID NOT EXPERIENCE ANY BACK PAIN OR SHORTNESS OF BREATH. HIS LUNGS WERE CLEAR. HIS DISCHARGE BLOOD PRESSURES WERE 146/62 SITTING AND 148/80 STANDING. THIS WA A NEW "DRY-PACK" DIALYZER. THE PT HAD BEEN PREVIOUSLY DIALYZED ON THIS TYPE OF MEMBRANE (POLYSULFONE) WITHOUT INCIDENT.
PT WAS FOUND BY 11-7 NURSE WEDGED PARTIALLY BETWEEN SIDERAIL AND DEFLATED AIR MATTRESS.
LUER LOCK SET WAS CHANGED FROM 54 INCH TO 60 INCH. THIS WAS NO PROBLEM; BUT THE LUER LOCK WAS CHANGED ALSO AND NOW DOES NOT FIT THE EPIDURAL CATHETERS. THIS IS A PROBLEM DURING EMERGENCY C-SECTIONS. FACILITY HAD TO SWITCH COMPANIES.
SPIKE ADAPTER FAILED TO VENT WHEN INFUSING TPA INTO CARDIAC ARREST PT. THIS CAUSED INFUSION PUMPS TO ALARM AND NOT FUNCTION. TPA HAD TO BE INFUSED MANUALLY. THIS CAUSED A DELAY IN INFUSION FROM 35 MINS TO 75 MINS.
7/95 RPTR HAD ROOT CANAL DENTAL WORK WITH RUBBER DAM RESULTING IN SEVERE SWELLING OF THROAT AND EYES. (ALSO SEE 1008971)
DURING AN INTERNAL AUDIT OF EXPLANTED GENERATORS STORED IN THE ARCHIVES, ASSOCIATED LEADS WERE DISCOVERED AND UPON INVESTIGATION OF THE EXPLANT REPORTS, INFO WAS DISCOVERED WHICH REQUIRED DISTRIBUTOR REPORTING. PER THE EXPLANT REPORT DATED 4/9/93, THE PACING ADAPTER WAS EXPLANTED DUE TO AN INSULATION BREAK. THE DEVICE, IMPLANT AND EXPLANT REPORT HAVE BEEN FORWARDED TO THE MFR ON 4/9/96.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PATELLA WAS BEGINNING TO WEAR THROUGH THE POLY.
CO WAS INFORMED THAT THE SENSE PACE LEAD ADAPTER WAS EXPLANTED DUE TO A BREAK NEAR THE INSERTION TO THE CONNECTOR BLOCK. IT WAS REPORTED THAT THE ICD WAS FUNCTIONING APPROPRIATELY.
THE PT IS A 30 YEAR OLD MALE, WHO COMPLAINED OF DIFFICULTY SWALLOWING AND TALKING AFTER SURGERY (TYPE OF SURGERY UNKNOWN). HE WAS REFERRED TO ANOTHER EAR, NOSE, THROAT PHYSICIAN WHO REPORTED THAT THE PT HAD LARYNGEAL EDEMA AND INFLAMMATION. PT WAS TREATED WITH ORAL STEROIDS. WHEN THE REPORTING PHYSICIAN EXAMINED THE PT LATER AT AN UNKNOWN TIMEFRAME, THERE WAS MARKED IMPROVEMENT WITH ONLY MILD REDNESS ON THE CORDS AND PUNCTATE ERYTHEMA OVER THE ARYTENOIDS. CLEANING PROCEDURES HAVE BEEN REVEIWED AT THIS SITE. NO ADDITIONAL INTO IS EXPECTED FROM THIS SITE. AS PER 21 CFR 802.24(C)(7), THE DEVICE LABELING FOR THE LARYNGEAL MASK AIRWAY DESCRIBES THE FREQUENCY AND SEVERITY OF THIS POSSIBLE ADVERSE EFFECT IN DETAIL. THE LABELING STATES THE FOLLOWING: "THE PT MAY EXPERIENCE A FEELING OF DRYNESS IN THE THROAT FOLLOWING LARYNGEAL MASK AIRWAY USE. THROAT SORENESS IS OF THE SAME ORDER AS THAT WHICH OCCURS WITH FACE MASK USE, BUT DRYNESS OF THE THROAT MAY OCCUR MORE FREQUENTLY." THE FREQUENCY OF SORE THROATS AFTER MASK USE HAS NOT INCREASED. THE LABELING ALSO STATES THAT A SEVERE OR PROLONGED SORE THROAT HAS BEEN REPORTED IN PTS IN WHOM AN IMPROPERLY CLEANED OR STERILIZED MASK HAS BEEN USED. THE LABELING ALSO PROVIDES DETAILED INSTRUCTIONS, WARNINGS AND PRECAUTIONS REGARDING HOW TO PROPERLY CLEAN AND STERILIZE THE MASK.
DURING A CARDIVASCULAR SURGERY, PT'S MYOCARDIUM WAS NICKED.
INTL DISTRIBUTOR HAS RETURNED A FAILED IMPLANT WITH NO FURTHER INFO AT THIS TIME.
CEMENT WAS BOWL MIXED THEN PASSED OFF FOR CENTRIFUGATION. THE NOZZLE WAS INSTALLED ON THE CARTRIDGE. AT TIME OF INJECTION INTO CANAL, THE CONSISTENCY OF CEMENT WAS GOOD. AFTER PRESSURIZING CANAL, IMPLANT WAS PARTIALLY INSERTED. THE DISTAL CEMENT HAD HARDENED. (THE PROXIMAL AND CEMENT IN SCRUB'S HAND WAS NOT TO THE DOUGH STATE YET). CEMENT HAD HARDENED IN 3-5 MINS. THE CEMENT IN THE FEMORAL CANAL HAD TO BE CHIPPED OUT AND DISPOSED OF. TWO LOT NUMBERS WERE MIXED TOGETHER DURING THIS SURGERY. FEMALE PT IS 71 YRS.
FOLEY CATHETER BALLOON DID NOT DEFLATE AND HAD TO BE SURGICALLY REMOVED.
CO LEARNED FROM THE CENTER THAT THE VENTILATOR "SHUT DOWN" AND ALARMED WHILE CONNECTED TO A PT. CO ALSO LEARNED THAT THE UNIT WORKED AFTER HAVING BEEN TURNED OFF AND BACK ON. ON 2/23/96 CO WAS INFORMED BY THE CENTER THAT THE PT HAD TO BE MANUALLY VENTILATED DURING THE INCIDENT AND WAS NOT INJURED.
INSERT WOULD NOT SEAT CORRECTLY. IT WOULD ROCK UP AND DOWN. USED ANOTHER INSERT (SAME SIZE, DIFFERENT LOT CODE) AND IT WORKED FINE.
PT PRESENTED WITH SOME PAIN. X-RAY REVEALED SOME WEAR OF POLY. KNEE WAS SCOPED, POLY DEBRIS WAS EVIDENT AND INSERT AND PATELLA WERE REPLACED.
CO WAS INFORMED THAT THE SENSE PACE LEAD WAS SENSING NOISE CAUSING INAPPROPRIATE SHOCKS. THE LEAD WAS CAPPED. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORM TO SPEC.
THE DEVICE STOPPED RUNNING WITHOUT ANY ALARM.
DURING AN INTERNAL AUDIT OF EXPLANTED GENERATORS STORED IN THE ARCHIVES, ASSOCIATED LEADS WERE DISCOVERED AND UPON INVESTIGATION OF THE EXPLANT REPORTS, INFO WAS DISCOVERED WHICH REQUIRED DISTRIBUTOR REPORTING. PER THE EXPLANT REPORT DATED 3/24/93, THE PACING LEAD ADAPTER WAS EXPLANTED DUE TO NOISE CAUSED BY A BREAK. THE DEVICE, IMPLANT REPORT AND EXPLANT REPORT, HAVE BEEN FORWARDED TO THE MFR ON 4/9/96.
DURING AN INTERNAL AUDIT OF EXPLANTED GENERATORS STORED IN THE ARCHIVES, ASSOCIATED LEADS WERE DISCOVERED AND UPON INVESTIGATION OF THE EXPLANT REPORTS, INFO WAS DISCOVERED WHICH REQUIRED DISTRIBUTOR REPORTING. PER THE EXPLANT REPORT DATED 7/7/93, THE PACING ADAPTER WAS EXPLANTED DUE TO NOISE. THE IMPLANT, AND EXPLANT REPORTS HAVE BEEN FORWARDED TO THE MFR ON 4/9/96.
DURING AN INTERNAL AUDIT OF EXPLANTED GENERATORS STORED IN THE ARCHIVES, ASSOCIATED LEADS WERE DISCOVERED AND UPON INVESTIGATION OF THE EXPLANT REPORTS, INFO WAS DISCOVERED WHICH REQUIRED DISTRIBUTOR REPORTING. PER THE EXPLANT REPORT DATED 7/2/92, THE PACING LEAD ADAPTER WAS EXPLANTED DUE TO AN INSULATION BREAK. THE DEVICE, IMPLANT REPORT AND EXPLANT REPORT, HAS BEEN FORWARDED TO THE MFR ON 4/9/96.
ON 3/7/96 DURING AN EMERGENCY GENERATOR TEST THE VENTILATOR STOPPED WORKING WHILE CONNECTED TO A PT. THE HOSP STATED THAT THE UNIT'S CIRCUIT BREAKER WOULD NOT RESET. THE PT HAD TO BE MANUALLY VENTILATED AND EXPIRED. THE UNIT WAS TESTED ON 3/8/96 IN THE HOSP BY CO AND THE HOSP'S BIOMEDICAL TECHS. THEY FOUND THE UNIT TO BE WORKING FINE ON WALL AIR. HOWEVER, WHEN THE WALL AIR IS DISCONNECTED, ITS COMPRESSOR DOES NOT START AND KEEPS TRIGGERING ITS CIRCUIT BREAKER. THE UNIT IS NOW AWAITING OEM EVALUATION AS IT IS UNDER WARRANTY FOR HAVING BEEN RECONDITIONED/CONVERTED BY THE MFR IN 1/96.
THE VENT WAS TO BE PLACED ON A PT. PASSED SELF TEST, AND FLOW SENSOR WAS CALIBRATED. AFTER ALL PARAMETERS HAVE BEEN SET TO THE DESIRED LEVELS, IT WAS OBSERVED THAT THE VENT DID NOT CYCLE NOR ALARM.
TWO MINS AFTER INITIATION OF CP BYPASS, BLOOD IN THE ARTERIAL LINE AND CARDIOPLEGIA CIRCUIT LOOKED DARK, DESPITE THE VENOUS SATURATION MONITOR READING 74%. THE O2 ANALYZER READ 100% O2 BEING DELIVERED. AFTER CHECKING THE CIRCUIT AND SWITCHING TO AN O2 TANK, FAILURE OF THE OXYGENATOR WAS SUSPECTED. CROSS CLAMP WAS REMOVED, CALCIUM WAS ADMINISTERED, THE PT WAS DEFIBRILLATED, AND BYPASS WAS TERMINATED. JUST PRIOR TO DISCONTINUING BYPASS AN ARTERIAL BLOOD GAS FROM THE PUMP LINE READ AN O2 SATURATION OF 23%. THE OXYGENATOR WAS REPLACED AND THE CASE WAS COMPLETED SUCCESSFULLY.
THE PROCEDURE BEGAN WITH THE INSERTION OF A 120MM NEEDLE FOR INSUFFLATION. THE NEEDLE WAS NOT LONG ENOUGH TO PENETRATE INTO THE ABDOMINAL CAVITY. CONSEQUENTLY, THE SURGEON SWITCHED TO A 150MM LONG NEEDLE. THE RESIDENT THEN INTRODUCED A 100MM TROCAR. UPON INSERTION OF THE SCOPE, IT WAS DISCOVERED THAT THE TROCAR HAD NOT COMPLETELY PENETRATED. DR THEN FORCEFULLY RE-INTRODUCED THE TROCAR, PENETRATING THE STOMACH WALL AND NICKING A SMALL AREA OF THE BOWEL. THE EVENT INVOLVES OBVIOUS MISUSE OF THE PRODUCT. THE SURGEON'S UTILIZATION OF A 100MM TROCAR IS CLEARLY INADEQUATE IN THAT A 150MM NEEDLE WAS REQUIRED TO PENETRATE THROUGH TO THE ABDOMINAL CAVITY.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE POLY HAD WORN THROUGH. THE PATELLA WAS REPLACED WITH A DIFFERENT DEVICE.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED WITH A DIFFERENT DEVICE.
EXCESSIVE POLY WEAR. THE 7MM INSERT WAS REMOVED AS WELL AS THE METAL BACKED PATELLA AND WERE REPLACED.
LITHOTRIPTOR BASIN WATER TOO HOT. DISCOVERED BEFORE PT WAS INJURED. RESISTOR, NORMALLY SET AT 40 DEGREES C, WAS AT 85 DEGREE C, ALLOWING WATER IN HOLDING TANK TO REACH 85 DEGREES C. CAUSE OF INCORRECT SETTING UNKNOWN. PTS HAD BEEN SAFELY TREATED ON DEVICE PRIOR TO THIS INCIDENT. RESOLUTION - RESISTOR SET TO 40 DEGREE C, NO FURTHER INCIDENCES SUBSEQUENTLY.
DURING POSITIONING, A FEMALE PT WEIGHING OVER 200 LBS WHO WAS QUITE AGITATED AND UNCOOPERATIVE, WHO HAD NOT BEEN GIVEN A SEDATIVE AND WITH NO ATTENDANT NEXT TO HER, MOVED SHARPLY, CAUSING THE SAFETY STRAPS TO BECOME INSECURE, AT WHICH POINT SHE FELL FROM THE PALLET AND WAS INJURED. THE SUBSIDIARY OVERSEAS WAS ONLY MADE AWARE OF THE SITUATION AS A RESULT OF A REQUEST BY THE CUSTOMER FOR LONGER SAFETY STRAPS. THE OPERATOR'S MANUAL THAT ACCOMPANIES THE CT CONTAINS CLEARLY STATED WARNINGS UNDER SECTION 1.9, ENTITLED "PATIENT HANDLING," NO 3 "MAKE SURE THAT THE PT IS STRAPPED SECURELY TO AVOID DANGLING OF THE HANDS. ENSURE THAT THE PT IS PLACED SECURELY ON THE STRETCHER AND IS NOT IN DANGER OF FALLING."
THE IMAGE DISAPPEARED DURING A PROCEDURE CAUSING THE PROCEDURE TO BE COMPLETED WITH THE USE OF A SECOND SCOPE. THERE WAS NO PT INJURY.
FOLLOWING SURGERY TO REPAIR A DISLOCATED TOE, THE COLD THERAPY PAD WAS PLACED OVER THE SURGICAL SITE AND CONTROLLED COLD THERAPY WAS ADMINISTERED. AFTER THREE DAYS OF CONTINUOUS TREATMENT, THE PT RETURNED FOR FOLLOW-UP WHEN IT WAS NOTED THAT HER TOE WAS DISCOLORED AND HER FOOT WAS COLD TO THE TOUCH. TWO WEEKS LATER, THE PT REQUIRED AN AMPUTATION OF THE OPERATED TOE.
THE INCUBATOR STOPPED RUNNING, GAVE ALARM AND THAT THE PT'S STATE OF HEALTH HAS BEEN DETERIORATED. PT'S WEIGHT 0.6 KGS.
CONTROLLER DISPLAY WAS INCORRECT WITH NO OUTPUT AND NO ALARM.
DEVICE FIRED BUT SURGEON COULD NOT SEE WHERE THEY WENT. SURGEON SAID THAT ANASTOMOSES DID NOT SUCCEED BECAUSE OF THE MISFIRING SO HAD TO BE ACCOMPLISHED BY HAND. THIS RESULTED IN EXTENDED SURGERY AND A COLOSTOMY WHICH MAY NOT HAVE NEEDED TO BE DONE. ANOTHER SURGEON FIXED THE DEVICE LATER.
POST-LAMINECTOMY SURGERY, THE PT WAS BEING TURNED FROM A PRONE POSITION ON THE OPERATING TABLE TO A SUPINE POSITION ON THE PT'S BED. THE BED WAS ALONGSIDE THE OR TABLE, AND THE LOCK APPLIED. AS THE PT WAS BEING TURNED, THE ASSISTANT STANDING AT THE SIDE OF THE BED TO CATCH THE PT FELT THE BED SLIP OUT AT THE HEAD END, AND THE PT FELL BETWEEN THE BED AND OR TABLE. THE FALL WAS SLOW AS THE ASSISTANT TRIED HARD TO HOLD THE BED AND THE ANESTHESIA PERSON PLUS NURSE TRIED TO CATCH THE PT AS HE SLIPPED DOWN.
LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PERFORMED. DEVELOPED ABDOMINAL PAIN, DISTENTION AND WAS EXPLORED ON 11/19/95 WITH FINDINGS OF BOWEL CAUGHT ON OPEN STAPLES IN SUTURE LINE RESULTING IN BOWEL OBSTRUCTION. PHYSICIAN NOW BELIEVES OBSTRUCTION WAS CAUSED BY MALFUNCTION OF STAPLER.
THE PRESCRIPTION FOR THE PT WAS 300C GY 1 FX GIVEN DOSE FOR 15 FRACTIONS WITH 6 MCV ELECTRONS TO AN AREA OF HIS RIGHT EAR. THE TREATMENT FIELD WAS SET UP USING THE 5CM DIAMETER PLASTIC TIP CONE. ACCELERATOR MONITOR UNITS NEEDED TO DELIVER THE PRESCRIBED DOSE WERE CALCULATED USING OUTPUT FACTORS FOR THE 5CM DIAMETER METAL CONE. THIS RESULTED IN THE PT RECEIVING 7 TREATMENTS OF 414C GY GIVEN DOSE (2898C GY/ 7FX). ONCE THIS ERROR WAS DISCOVERED THE PRESCRIPTION WAS AMENDED BY THE PHYSICIAN TO DECREASE THE DOSE RATE TO 200 C GY PER FRACTION FOR THE REMAINING 8 TREATMENTS. AT COMPLETION OF THIS COURSE OF TREATMENT,THE PT WILL HAVE RECEIVED 4500 C GY GIVEN DOSE IN 15 FRACTIONS.
EYE MICROSCOPE MALFUNCTIONED DURING CATARACT CASE, ELECTRICAL PROBLEM IN EQUIPMENT (FUSE). PT NEEDS TO HAVE A RETURN TO SURGERY AT A FUTURE DATE.
UPON ADMISSION OF PT FOR CHEMOTHERAPY INFUSION, IT WAS NOTED THAT THE CATH WAS BROKEN. ACCORDING TO THE "RETRIEVAL OF INTRAVASCULAR FOREIGN BODY IN THE CHEST," THE CENTRAL VENOUS CATHETER BROKE IN THE SUBCLAVICULAR AREA ON THE LEFT WITH THE FRAGMENT FLOATING CENTRALLY, PROBABLY INTO THE RIGHT SIDE OF THE HEART, AT LEAST SOME OF WHICH APPEARS TO BE TRANSVERSE INTO THE REGION OF THE RIGHT ATRIUM. THE PORT PORTION OF THE CATHETER IS PROJECTING OVER THE LEFT UPPER CHEST FELT TO BE THE ANTERIOR CHEST WALL.
CAPSULAR CONTRACTURE ON LEFT SIDE AND A RUPTURED IMPLANT ON THE RIGHT SIDE.
PT UNDERWENT RETROPUBIC RADICAL PROSTATECTOMY ON 4/15/96. A DRAIN WAS PLACED ON RIGHT SIDE OF MAIN INCISION. PT IN MD'S OFFICE ON 4/23/96 FOR REMOVAL OF DRAIN. ON REMOVAL, THE DRAIN BROKE ON THE TUBING PORTION OF THE DRAIN LESS THAN 1CM FROM THE WIDE DRAIN PORTION ITSELF. PT HAD EXPLORATORY LAPAROTOMY, REMOVAL OF DEFECTIVE DRAIN ON 4/23/96 UNDER GENERAL ANESTHESIA. NO COMPLICATIONS. WAS 23-HR OBSERVATION PT.
CATHETER WAS PLACED AS A CENTRAL VENOUS CATHETER ON 1/15/96. CATHETER TIP PLACEMENT WAS VERIFIED BY X-RAY. PT REPORTED NO PROBLEMS WITH CATHETER DURING 9 WEEK COURSE OF ANTIBIOTIC THERAPY. AT END OF THERAPY, THE NURSE WAS UNABLE TO REMOVE THE CATHETER FROM THE PT'S VEIN. A VASCULAR SURGEON INTERVENED TO REMOVE THE CATHETER.
MENISCAL BEARING BROKE AND DISLODGED; REQUIRED SURGERY TO REPLACE BEARING.
MALFUNCTION OF A INFLATABLE PENILE PROSTHESIS (KINK IN SYSTEM). UNABLE TO GET LEFT CYLINDER HARD.
UPON COMPLETION OF THE CT OF THE CHEST (WITH CONTRAST), THE PT WAS ASSISTED OFF THE EXAM TABLE. THE PT IMMEDIATELY BEGAN COMPLAINING ABOUT WEAKNESS AND SHORTNESS OF BREATH. AT THIS POINT, THE STAFF ASSISTED THE PT ONTO A STRETCHER, ELEVATED THE FEET AND SUMMONED A RADIOLOGIST. RADIOLOGIST DIRECTED THE STAFF TO TAKE THE PT TO THE ER. ON CT SCANS, THE RADIOLOGIST DISCOVERED 20CC OF AIR IN HEART. IT APPEARS THAT AIR WAS SOMEHOW INTRODUCED INTO THE VENOUS SYSTEM.
THIS 40-YR-OLD FEMALE HAD SUBPECTORAL BREAST AUGMENTATION WITH SILICONE GEL IMPLANTS IN 1987. SHE HAD DEVELOPED CAPSULAR CONTRACTURE (GRADE III LEFT AND GRADE II RIGHT) AND MRI EVIDENCE OF PROBABLE INTRACAPSULAR FAILURE OF THE LEFT. ON 3/27/96, SHE UNDERWENT BILATERAL CAPSULECTOMY AND BREAST IMPLANT REMOVAL.
PT RECEIVED TEMPORARY DRAIN IMPLANT IN SURGICAL SITE. WHILE ATTEMPTING REMOVAL OF DRAIN A "POP" WAS HEARD AND THE DRAIN SHEARED LEAVING A PORTION INSIDE THE PT. THE PT WAS RETURNED TO SURGERY FOR REMOVAL OF THE SEGMENT.
IABP BALLOON CATHETER RUPTURED AND BLOOD BACKED UP INTO THE CATHETER.
RESIDENT WAS IN A RECLINING GERI CHAIR. STAFF FOUND RESIDENT TURNED OVER IN CHAIR HALFWAY IN CHAIR AND PARTIALLY LYING ON CHAIR, ARM ON FLOOR. PHYSICIAN WAS NOTIFIED AND CAME TO SEE RESIDENT AND DID NOT SEE ANYTHING WRONG AT THIS TIME. (PHYSICIAN DID ORDER PAIN PILL AND TO OBSERVE RESIDENT). RESIDENT KEPT COMPLAINING AND X-RAY WAS ORDERED ON 3/25/96 AND ON 3/26/96 WAS TAKEN. X-RAY SHOWED FRACTURE OF LEFT LATERAL 7TH RIB AND QUESTIONABLE FRACTURES OF 6TH AND 8TH LEFT RIB. POSSIBILITY THAT FRACTURES CAME FROM OVERTURNED CHAIR.
WHILE FLUSHING CATHETER, DISTAL END OF CATHETER CAME APART. LINE DISCONNECTED WHILE FLUSHING.
FLUSHING CATHETER - DISTAL END BROKE APART.
CATHETER LEAKING FROM DISTAL CATHETER END.
PT ADMITTED TO IMC FOR PACEMAKER FAILURE. PACEMAKER TESTED AGAIN, NOT SENSING OR CAPTURING. PACEMAKER EXPLANTED, NEW PACEMAKER IMPLANTED.
NOTED DEFLATION OF RIGHT BREAST IMPLANT APPROX 6 WKS AGO, FOLLOWING SEVERE BRONCHITIS WITH ASSOCIATED COUGHING. PT WANTS IMPLANT REPLACED.
PT ENTERED FACILITY 3/27/96 FOR ATTEMPTED TOTAL HIP REVISION ARTHROPLASTY DUE TO FRACTURED ACETABULAR CUP. POLYETHELENE ACETABULAR LINER WAS FRACTURED AND BLACK METAL DISEASE WAS FOUND THROUGHOUT THE AREA. ACETABULAR CUP AND FEMORAL HEAD IMPLANT WERE REMOVED. THE ACETABULM HAD BEEN ERODED THROUGH THE MEDIAL WALL.
DURING AN OPERATIVE PROCEDURE, THE STAPLE GUN TRIGGER BROKE WHEN FIRED. SMALL PIECES OF PLASTIC WERE RETRIEVED FROM ABDOMINAL INCISION SITE.
PT UNDERWENT SURGICAL PROCEDURE REQUIRING DRAINAGE DEVICE. UPON ORDERED REMOVAL OF DRAINAGE DEVICE, DRAIN BROKE. PART OF DRAINAGE DEVICE RETAINED IN PT'S ABDOMEN, REQUIRING SURGICAL INTERVENTION FOR REMOVAL. AT TIME OF REMOVAL, IT WAS NOT DISCOVERED THAT PART OF THE DRAIN WAS RETAINED.
FAINTNESS AT WORK PRECIPITATED TRANSPORT TO HOSP. UPON ADMISSION, BP 70. EKG, ECHO, CXR, CHEST/ABD CT SCAN SHOWED NO REASON FOR DECREASING BP. TAKEN EMERGENTLY TO OR FOR PRESUMED CATASTROPHIC PROSTHETIC VALVE FAILURE. REQUIRED CPR PRIOR TO ARRIVAL IN OR. SURGERY CONFIRMED THIS DIAGNOSIS. DIED IN OR.
DURING BOTH INCIDENTS THE RESIDENT WAS BEING TRANSFERRED FROM WHEELCHAIR TO BED. IN THE PROCESS OF BEING TRANSFERRED, THE RESIDENT MOVED HER ARMS WHICH CAUSED ONE OF THE LIFT, SHEET HOOKS TO COME OFF THE LIFT HOOK CAUSING THE RESIDENT TO FALL TO THE FLOOR. THE RESIDENT'S CHIEF COMPLAINT AFTER EACH INCIDENT WAS PAIN AT THE SITE WHERE HER HEAD HIT THE FLOOR. SHE HAD A .5 CM SKIN CUT TO HER SCALP AFTER THE FIRST INCIDENT. ADD'L EVENT DATE 3/2/96.
RPTR STATES THERE WAS A FAILURE OF A PRESSURIZED WATER BOTTLE. THE MFR EVALUATED THE DEVICE AND REPLACED WITH ANOTHER DEVICE.
IV DUAL CHAMBER PERIPHERAL TPN BAG FAULTY. IT SEPARATED WHERE IT IS HEAT-SEALED, 1/4" FROM ADDITIVE PORT, 1 DAY AFTER MIXED.
RPTR HAD A "HOLE" IN L3 DISK. BONE TAKEN FROM HIP TO REPAIR. THEN PLATES AND SCREWS PUT IN BACK TO STABILIZE FUSION IN BACK. RPTR HAS NOT BEEN WELL EVER SINCE SURGERY.
TIP OF CATHETER CURLED BACK ON ITSELF AND WASN'T ABLE TO BE INSERTED.
PORTION OF PREP SPONGE RETRIEVED POST-OP FROM PREP AREA (VAGINAL). PIECE WAS NOT FOUND UNTIL PT SAW PHYSICIAN ON 3/11/96. THIS IS THE SECOND INCIDENT.
BAXTER HEALTHCARE CORP. ROUTE 120 & WILSON RD, ROUND LAKE, IL 60073-0490. EVALULATION RESULTS. EIGHTEEEN UNUSED SUBCUTANEOUS ADMINISTRATION SETS OF THE REPORTED LOT NUMBER WERE RETURNED FOR EVALUATION. A PUSH TEST WAS PERFORMED ON THE 27 GAUGE SUBCUTANEOUS NEEDLE USING A FORCE GAUGE. THE PUSH FORCES RANGED FROM 0.14 TO 0.31 POUNDS. ALL OF THE NEEDLES BENT DOWNWARD AND REBOUNDED TO THEIR ORIGINAL BEND WHEN RELEASED. THE NEEDLES WERE VISUALLY INSPECTED AFTER THE PUSH TEST USING 10X MAGNIFICATION. NO CRACKS OR OTHER DEFECTS WERE OBSERVED. IN SUMMARY, NO ABNORMALITIES IN THE NEEDLES OF THE ADMINISTRATION SETS WERE FOUND. WITH THIS REPORT IT WAS COMMENTED THAT THE ABDOMINAL SITE WAS USED AND THIS AREA WAS FREE OF BELTS OR RESTRAINTS. IT IS NOT KNOWN IF OTHER FACTORS WERE INVOLVED. THERE IS NO STATEMENT IN THE PRODUCT LABELING REGARDING FREQUENCY OR SEVERITY WITH THIS ISSUE, NOR IS THERE ANY EXPECTED FREQUENCY OR SEVERITY OF OCCURRENCE WITH THIS ISSUE. A REVIEW OF OUR COMPLIANT DATABASE SHOWED FOUR OCCURRENCES IN 1995 AND ONE ADD'L OCCURENCE IN 1996 FOR BREAKAGE OF THE NEEDLE. THREE OF THESE PREVIOUS OCCURRENCES INVOLVED DISERTION OF THE DEVICE INTO THE LEG OR THIGH AREA OF THE PTS, WERE EXCESSIVE MANIPULATION CAN OCCUR.
DURING THE BALLOON DILATION PHASE OF ERCP, THERE WAS A SUDDEN LEAK IN THE BALLOON WITH EXTRAVASATION OF STERILE SALINE INTO THE DORSAL DUCT. PT DEVELOPED ACUTE PANCREATITIS.
PT BELIEVES HE IS REACTING TO THE SPERMICIDE. PT USED 1 CONDOM 3/20 PM AND 3/21 AM. PT REPORTS VERY SEVERE BURNING AT THE URETHRAL OPENING ON URINATION, REDNESS AND INDURATION OF APPROX 2-3 ML AROUND TIP. NO BLOOD OR DISCHARGE SEEN. PT INDICATED A SIMILAR BUT MUCH LESS SEVERE RESPONSE OCCURRED WITH THE SAME PRODUCT ABOUT 1 YEAR AGO.
DISTAL PORTION (APPROX 2 1/2 - 3CM) OF 12 MM DISPOSABLE SURGICAL TROCAR BROKE OFF DURING INSERTION INTO THE PT'S ABDOMEN. 80-90% OF FRAGMENTS WERE REMOVED. SMALL PORTION REMAINED IN PT'S ABDOMEN.
PT BLEEDING FROM PERIPHERALLY INSERTED CENTRAL CATHETER. TUBING APPEARED BROKEN.
NURSE WAS CHECKING THE "LEAKING" IV/HEPLOCK SITE ON RIGHT WRIST AND, AS SHE REMOVED THE TAPE SHE OBSERVED THE CATHETER HUB WITH APPROX 1/8" OF CATHETER HANGING FREELY. X-RAYS IDENTIFIED THE REMAINING IV CANNULA ABOVE THE RIGHT WRIST AREA. A CUT-DOWN WAS PERFORMED PER DR AND REMAINING CANNULA REMOVED. NO ADVERSE EFFECT OCCURRED TO PT. THE IV HAD BEEN STARTED ON 4/19/96 WITHOUT DIFFICULTY ON FIRST ATTEMPT BY NURSE.
20 GA COPOLYMER BULLET-TIP EPIDURAL CATHETER WAS INSERTED AND THEN FOUND TO HAVE NO OUTLET HOLES. EPIDURAL NEEDED TO BE RESTARTED. RPTR HAS FOUND TWO SUCH CATHETERS.
RPTR INDICATED THAT THEY ARE NOW PACKAGING THE CONTAINERS INDIVIDUALLY IN BUBBLE WRAP WITH A LIMITED NUMBER OF BAGS SHIPPED IN EACH CASE. THEY HAVE NOT EXPERIENCED ANY FURTHER PROBLEMS.
FREQUENT CHANGING OF PRODUCTS IN BAGS (EG STERILE WATER OR LACTATED RINGERS) IN TUBING SETS CREATES ENOUGH FRICTION TO CAUSE PLASTIC FROM BAGS TO BE RUBBED OFF. UPON CHANGING THE BAGS SOME OF THE PLASTIC "FLAKES" COULD POSSIBLY BE INTRODUCED INTO PRODUCT WHICH IN TURN COULD BE INTRODUCED INTO FINAL COMPOUNDED PRODUCT. PRODUCTS ARE USED TO FORMULATE TPN.
PULSE OXIMETER READS INTERMITTENTLY GIVING INACCURATE RESULTS FOR SAO2 AS COMPARED WITH COOXIMETER. THREE INCIDENTS OCCURRED AND THE MFR WAS NOTIFIED. ALL UNITS WERE REPLACED BY OTHER UNITS BY THE MFR.
LAPAROSCOPIC CLIP APPLIER FAILED TO RELOAD AND APPLY CLIP ON CYSTIC ARTERY. FURTHER FORCE APPLIED. APPLIER DID NOT LOAD CLIP.
WHILE PT WAS HAVING AN ANGIOGRAPHY PROCEDURE, ONE OF TWO MOUNTING BRACKETS FOR THE FILM CHANGER WAS NOTED TO BE BROKEN. THE FILM CHANGER WAS TILTED. THE PT WAS REMOVED FROM THE TABLE. THE SECOND BRACKET THEN BROKE CAUSING THE FILM CHANGER TO FALL.
OPERATIVE PROCEDURE IN-SITE PINNING OF BILATERAL SLIPPED CAPITAL FEMORAL EPIPHYSIS. DURING PROCEDURE A 7.3 CANNULATED SCREW WAS BEING PLACED TO THE LEFT FEMORAL NECK/HEAD WITH POWER SCREW TIP PER SURGEON. POST PLACEMENT, C-ARM FILM REVEALED FOREIGN BODY IN LEFT FEMORAL NECK. SCREW REMOVED AND INSPECTED AND NOTED TWO OF THE THREE CUTTING TIPS WERE ABSENT.
SURGEON PERFORMING DEROTATIONAL OSTEOTOMY OF LEFT FEMUR. DURING APPLICATION OF HARDWARE, WITH INSTRUMENT MADE TO APPLY IMPLANT, TIP OF INSTRUMENT BROKE OFF AND REMAINED IN THE IMPLANT.
PT HAD SEVERE ALLERGIC REACTION TO LATEX RESULTING FROM PROLONGED EXPOSURE TO LATEX, BOTH CONTACT AND AIRBORNE. PT HAS SYMPTOMS OF URTICARIA, RHINITIS, ASTHMA, DERMATITIS, OCCIPITOFRONTAL SWELLING, CORONARY ARTERY SPASMS.
MEDICAL PRODUCTS ARE NOT LABELED WITH LATEX CONTENT. THIS APPLIES TO ALL HEALTHCARE PRODUCT MFG INDUSTRY-WIDE. THE ABILITY TO CARE FOR LATEX-SENSITIVE PTS AND LATEX-SENSITIVE HEALTH CARE WORKERS IS COMPROMISED BY THE LACK OF LATEX CONTENT LABELING.
IMPLANT WAS PLACED WITHIN PT. PHYSICIAN IMMEDIATELY EXPLANTED DEVICE TO INSERT A DRAIN. UPON EXPLANTATION, DEVICE RUPTURED. NO HARM TO PT.
RPTR HAD BILATERAL SILICONE BREAST IMPLANTS. THEY WERE REMOVED DUE TO HEMORRHAGING, THEN REINSERTED. SHE HAS HAD A TOTAL OF 6 BREAST SURGERIES. SHE HAD A HEMATOMA AND NUMBNESS IN THE SURGICAL AREA. SHE HAD CALCIUM DEPOSITS, A MEDICAL PROFESSIONAL HAS CONFIRMED EXTENSIVE SILICONE IN HER CHEST WALL. SHE HAD BLEEDING THROUGH THE ENVELOPE AND BREAST IMPLANTS RUPTURED. SHE C/O: CHRONIC BLADDER/URINARY INFECTIONS, BLOOD PRESSURE PROBLEMS, SHORT-TERM MEMORY LOSS, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, REDUCED BLOOD FLOW TO BRAIN, CHEST/RIB CAGE PAIN &/OR BURNING SENSATION AND INFLAMMATION, ELEVATED CHOLESTEROL OR TRIGLYCERIDES, CATARACTS, HOLES IN RETINA, THYROID PROBLEMS, ADRENAL PROBLEMS, CHRONIC SWELLING, DISCOLORATION (RED OR BLUE) AND HEAT OR COLD SENSITIVITY OF EXTREMITIES, RAYNAUD'S DISEASE, CRONIC DIARRHEA &/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, FREQUENT MIGRAINES/SEVERE HEADACHES, ARRHYTHMIAS, CONNECTIVE TISSUE DISEASE, JOINT INFLAMMATION, SWELLING, PAIN/ARTHALGIA AND RHEUMATOID ARTHRITIS, PERSISTENT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS AND AT GROIN, MUSCLE PAIN & BURNING, FIBROMYALGIA, UNEXPLAINED RASHES, SUN SENSITIVITY, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, CLUMSINESS/DROPS THINGS.
RPTR HAD BREAST IMPLANTS PLACED 8/91. SHE HAD INFECTION AND NUMBNESS IN THE SURGICAL AREA, BLEEDING THROUGH THE ENVELOPE AND CALCIUM DEPOSITS. ACCORDING TO 10/7/95 PATHOLOGY REPORT SHE HAD CYSTIC MASTITIS, PERILOBULAR-FIBROSIS, SEVERE VASCULITIS, CALCIFICATION OF THE BREAST, ATROPHY OF THE BREAST TISSUE, INFLAMMATION AND FIBROSIS, FIBROCYSTIC DISEASE AND MUSCLE DEGENERATION. SHE C/O: PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, MULTIPLE SCLEROSIS, ATYPICAL M-S, STROKE, CERVICAL CANCER, CHEST/RIB CAGE PAIN &/OR BURNING SENSATION, NERVE DAMAGE, RAPID DETERIORATION AND NEURITIS OF EYES, CHRONIC SWELLING, PAIN, DISCOLORATION (RED OR BLUE) AND HEAT OR COLD SENSITIVITY OF EXTREMITIES, RAYNAUD'S DISEASE, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENTITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME, HEAVY MENSTRUATION, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, FREQUENT MIGRAINES/SEVERE HEADACHES, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, LUPUS, SJOGREN'S SYNDROME, SCLERODERMA, JOINT INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT STIFFNESS OF JOINTS, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, MYOSITIS OR POLYMYOSITIS, FASCITIS, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, GRANULOMAS OR SILICANOMAS, CLUMSINESS/DROPS THINGS AND MISJUDGES DISTANCE/RUNS INTO OBJECTS. (*)
PT HAD THE CATHETER PLACED 2/9/93. SHE NOTICED REDNESS APPROX 24 HRS AFTER THE IV WAS PLACED. THIS WAS TREATED WITH HOT PACKS ON SUGGESTION OF THE HOME HEALTH AGENCY. SHE NOTICED SWELLING AND ERYTHEMA ON 2/14. THE IV WAS DISCONTINUED; HOWEVER, HER LEFT ARM HAD EXTENSIVE ERYTHEMA FROM THE WRIST TO 5 CM DISTAL TO THE SHOULDER. IT WAS EXQUISITELY TENDER OVER THE ENTIRE INNER ASPECT UP TO THE AXILLA. THERE WAS A PALPABLE CORD NEAR THE ANTECUBITAL FOSSA. SHE HAD A TEMPERATURE OF 100 TO 101. ON 2/16 THE PICTURE WAS SOMEWHAT IMPROVED BUT SHE STILL HAD TENDERNESS ALONG THE COURSE OF THE BASILIC VEIN AND IT WAS FELT THIS REPRESENTED A SEPTIC PHLEBITIS. SHE WAS TAKEN TO THE OPERATING ROOM, WHERE SHE HAD EXCISION OF THE BASILIC VEIN.
RPTR HAD BREAST AUGMENTATION 1978. SHE BEGAN HAVING MINOR SYMPTOMS IN 1990. IN 1995 SYMPTOMS WORSENED EXTREMELY SUCH AS SEIZURES AND COGNITIVE PROBLEMS (MEMORY, CONFUSION, DISORIENTATION, STAGGERING GAIT, SLURRED SPEECH). SHE HAD THESE EPISODES 1 TO 6 TIMES A WEEK. THIS RESULTED IN LOSS OF JOB, LOSS OF DRIVER'S LICENSE, 2 CAR ACCIDENTS, FALLING DOWN. ONCE SHE FRACTURED HER ORBITAL BONE AND ONCE SHE FELL DOWN 14 STAIRS AND SPRAINED HER ANKLE. SHE ALSO HAS IMMUNE SYSTEM PROBLEMS.
POSSIBLE DESIGN DEFECT OF SOFTWARE DESIGN WHICH LEADS THE USER TO INADVERTENTLY LOCK OUT CHANNELS OF THE PUMP. WHILE MEDICATION ADMINISTRATION CAN BE SWITCHED TO ANOTHER CHANNEL, UNLOCKING THE CHANNEL CAN ONLY BE ACCOMPLISHED BY THE MFR'S SVC ENGINEER. RPTR CURRENTLY MAINTAINS 496 OF THESE INFUSION PUMPS.
PT IS A 72-YR-OLD MALE WITH LONG STANDING HISTORY OF PARKINSON'S DISEASE. HE DEVELOPED EXTREME DIFFICULTY IN SWALLOWING DUE TO OROPHARYNGEAL DISCOORDINATION. HE SUFFERED FROM FREQUENT ASPIRATION AND WAS BECOMING MALNOURISHED DUE TO POOR ORAL INTAKE. HE UNDERWENT PLACEMENT OF A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE ON 10/27/94. FAMILY HAD BEEN CARING FOR PT. PT ADMITTED TO THE HOSP 3/25/96 WITH ASPIRATION PNEUMONIA. THE FAMILY REQUESTED REPLACEMENT OF PEG TUBE DUE TO POOR FUNCTIONING. SURGEON ATTEMPTED REMOVAL BY TRACTION AS IS CONSISTENT WITH INSTRUCTIONS. WHILE REMOVING TUBE HE HEARD A "POP" AND OBSERVED BREAKAGE. HE TRIED TO PLACE NEW FOLEY CATHETER BUT COULD NOT ASPIRATE ANYTHING. GASTRIC X-RAY SHOWED BROKEN PORTION OUTSIDE OF STOMACH. THIS WAS CONFIRMED WITH UPPER ENDOSCOPY. REQUIRED SURGICAL REMOVAL OF BROKEN PORTION OF PEG TUBE AND PLACEMENT OF NEW GASTROSTOMY TUBE.
WE WERE INFORMED BY THE HOSPITAL THAT A PT DIAGNOSED WITH CONGESTIVE HEART FAILURE WAS INTUBATED AND CONNECTED TO THE VENTILATOR.  THE HOSPITAL ALLEGED THAT "HIGH PITCHED HUMMING NOISES AND VIBRATION"A WAS NOT4ED IMMEDIATELY AFTER TURNING ON THE EQUIPMENT.  TH EHIGH PRESSURE LIMIT WAS ALLEGEDLY SET AT 80 CM AND ALARM WENT OFF.  THE PT ALLELLEDGELY HAD RESPIRATORY ARREST AND PNEUMOTHORAX ON LEFT SIDE.  THE HOSPITAL CLAIMED THIS SITUATION HAD TO BE CORRECTED WITH CHEST TUBES.  ON DECEMBER 30, THE HOSPITAL INFORMED US THAT THE PT WAS STILL ON THE RESPIRATOR, AND IN FAIR CONDITION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-AUG-92.  SERVICE PROVIDED BY:  DISTRIBUTOR.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, COMPUTER HARDWARE PERFORMANCE TESTS CONDUCTED, COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  DEVICE WAS OUT OF SPEC BUT THIS DOES NOT RELATE TO EVENT, DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  OTHER.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WE WERE INFORMED BY HOMECARE COMPANY NAMED BELOW OAN 3/18/93 THAT A PT WAS ALLEGED TO HAVE HAD ULL RESPIRATORYARREST AND WAS ADMITTED TO THE EMERGENCY ROOM OF A HOSPITAL IN HOUSTON. THE PT WAS ALLEGEDLY RECEIVING MORPHINE THROUGH THE INFUSION PUMP IN QUESTION SINCE 3/15/93.  NO DETAILS ABOUT THE SETTINGS AND VOLUME INFUSED WERE PROVIDEDD.  NO INFORMATION ABOUT THE PT'S AGE, SEX, MEDICAL STATUS PRIOR AND AFTER ALLEGED EVENT WAS PROVIDED.  THE PUMP WAS FORWARDED BY THE PT'S FAMILY TO THE MFG, WHICH TESTED IT FROM 3/31 TO 4/1.  ACCORDING TO THE MFG NO PERFORMANCE PROBLEM WAS FOUND AND ALL PARAMETERS WERE WELL WITHIN THE SPECS OF THE MFG.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-FEB-93.  SERVICE PROVIDED BY:  DISTRIBUTOR.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  OTHER.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
HOSPITAL REPORTED THE VENTILATOR IN QUESTION STOPPED WORKING ON A PT WITHOUT ALARM CODE OR AUDIBLE ALARM ON JUNE 17, 1993, AROUND 1 PM.  HOSPITAL ALSO INFORMED THE PT WAS "BAGGED" AND PUT ON ANOTHER VENTILATOR, AND NO INJURY OR HARM HAPPENED TO THE PT.  HOSPITAL STATED THE VENTILATOR WAS USED TOGETHER WITH COMPRESSOR, HUMIDIFIER AND O2 BLENDER.  DISTRIBUTOR TECHNICIAN FOUND SETTINGS ON THE UNIT DRIFTING AND OCCASIONAL "VENT INOP" WOULD OCCUR WITH AND WITHOUT ERROR CODE, BUT THE AUDIBLE ALARM ALWAYS WORKED.  THE PROBLEM WAS TRACED BY THE TECHNICIAN TO POOR CONNECTION BETWEEN THE DISPLAY PC BOARD AND A RIBBON CABLE.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-MAY-93.  SERVICE PROVIDED BY:  DISTRIBUTOR.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  DISPLAY BOARD, CABLE, CONNECTOR OR ADAPTOR.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE TEMPORARILY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
HOSPITAL REPORTED ON JUNE 15, 1993, THE VENTILATOR IN QUESTION STOPPED WORKING ON A PT ON JUNE 10 AROUND 2 AM,  HOSPITAL ALSO INFORMED THE PT WAS "BAGGED" AND PUT ON ANOTHER VENTILATOR, AND NO INJURY OR HARM HAPPENED TO THE PT.  THE DISTRIBUTOR'S TECHNICIAN FOUND THE VENTILATOR'S 5-VOLT POWER SUPPLY TO BE DEFECTIVE.  THIS FINDING WAS CONFIRMED BY THE MFG'S TECHNICIAN ON JUNE 22, 1993, WHEN THE VENTILATOR WAS REPAIRED.  NO OTHER INFORMATION ABOUT THE PT IS AVAILABLE.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-MAY-93.  SERVICE PROVIDED BY:  DISTRIBUTOR.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  OTHER, POWER SUPPLY.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE REPAIRED AND PUT BACK IN SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT HAD WOUND DEHISCENCE FOLLOWING ORIF OF RIGHT ANKLE. SHE ALSO HAS SEVERAL AREAS OF PRESSURE FROM SPLINTING AND SOFT DRESSINGS. PT WAS ADMITTED AND UNDERWENT REMOVAL OF IMPLANTS.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  THERE WAS NO DEVICE FAILURE.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT SLOWLY BEGAN DEVELOPING PAIN AND INCREASING PROBLEMS ABOUT HER LEFT HIP. SHOWED SIGNS OF AVASCULAR NECROSIS. FEMORAL HEAD WITH NAIL PENETRATING THROUGH THE REMAINING PORTION OF THE HEAD. PERTINENT PHYSICAL FINDINGS ON ADMISSION SHOWED PAIN WITH ANY ATTEMPTED RANGE OF MOTION OF HER HIP AND SHORTENING. X-RAYS REVEALED A VASCULAR NECROSIS WITH DEGENERATIVE CHANGES ABOUT THE LEFT HIP. ADMITTED FOR REVISION.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT HAD THE IPP PLACED IN 1991 AND HAD NO PROBLEMS UNTIL RECENTLY. FOLLOWING A FALL, HE HAD BEEN HAVING SOME PAIN IN PENIS AND NOW IS HAVING PROTRUSION OF THE CYLINDERS BENEATH THE GLANDS. PT WAS ADMITTED FOR REMOVAL OF IPP.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
BILATERAL BREAST IMPLANT EXCHANGE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE LEFT BREAST IMPLANT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN, NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
ON 9/8/95, PT UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, SPHINCTEROTOMY, DILATION OF BILIARY STRICTURE WITH CATHETER, AND PLACEMENT OF 11.5 FRENCH BILIARY STENT. X-RAYS DEMONSTARTED POSITIONING OF STENT THROUGH SEGMENTAL STENOSIS WITH GOOD DRAINAGE OF INTRAHEPATIC BILIARY SYSTEM. ON 9/9/95, CT ABDOMEN SCAN NOTED PT BILIARY STENT. ON 9/12/95, ABDOMEN/KUB FILM CONFIRMED CEPHALAD MIGRATION OF BILIARY ENDOPROSTHESIS. ON 9/13/95, PT UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY WITH COMPLICATED STENT RETRIEVAL AND STENT REPLACEMENT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  OTHER.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS 87-YR-OLD FEMALE PT UNDERWENT PLACEMENT OF RIGHT RADIAL ARTERIAL LINE AND CENTRAL VENOUS PRESSURE MONITORING LINE IN PREPARATION FOR LEFT THORACOSCOPY. CHEST X-RAY OBTAINED POSTOPERATIVELY CONFIRMED PRESENCE OF RETAINED GUIDE WIRE PARTIALLY WITHIN RIGHT JUGULAR TRIPLE-LUMEN CATHETER. PT WAS TRANSFERRED TO IMAGING SVS DEPT, WHERE GUIDE WIRE FRAGMENT WAS RETRIEVED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS DESTROYED/DISPOSED OF.
AN INCIDENT OCCURRED WHILE PERFORMING A CARDIAC CATHETERIZATION. UPON WITHDRAWAL OF THE GUIDE WIRE THROUGH THE INTRODUCER SHEATH RESISTANCE WAS ENCOUNTERED. UPON REMOVAL IT WAS NOTED THE GUIDE WIRE HAD UNRAVELED. X-RAY REVEALED THAT APPROX 1 1/2" OF THE WIRE REMAINED EMBEDDED IN FATTY TISSUE IN THE PT'S GROIN NEAR THE BIFURCATION. THE PT WAS IMMEDIATELY TRANSFERRED TO ANOTHER HOSP. SURGICAL RETRIEVAL OF THE DETACHED SEGMENT WAS SUCCESSFUL. THE PT EXPERIENCED NO SEQUELAE AS A RESULT OF THIS EVENT AND HAS BEEN DISCHARGED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE DISCARDED.  THE DEVICE WAS DESTROYED/DISPOSED OF.
USED TO STABILIZE FX CABLE. USED TO SECURE THE PLATE PROXIMALLY AND DISTALLY AND CORTICAL. SCREWS WERE USED DISTALLY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT A PT WITH THIS MYOCARDIAL LEAD RECEIVED INAPPROPRIATE SHOCKS FROM HIS AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) IN 2/93. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE TO EVALUATE THE SYSTEM AND REPAIRED ONE OF THE PT'S LEADS. CO DOES NOT KNOW WHICH OF THE LEADS WAS REPAIRED. SUBSEQUENLTY, IN 2/94, THE PT HAD BOTH OF THE LEADS REMOVED FROM SVC BECAUSE HE AGAIN EXPERIENCED INAPPROPRIATE SHOCKS. CO SUBMITTED A SERIOUS INJURY DISTRIBUTOR REPORT ON THE 2/94 EVENT ON 2/21/94. DISTRIBUTOR ACCESS NUMBER 2124215-1994-0014. IMPLANT DATE 11/26/91. REPAIRED 2/93. REMOVED FROM SVC 2/14/94.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
APPROX THIRTY-FIVE STAFF MEMBERS EXPERIENCED BURNING SENSATION, ITCHING AND RAW HANDS WHILE USING LAXTEX EXAM GLOVES. ONE STAFF MEMBER WENT TO EMPLOYEE HEALTH AND RECEIVED UNKNOWN PRESCRIPTION AND ONE STAFF MEMBER SWITCHED TO VINYL GLOVES. MFR UNKNOWN DUE TO LOT NUMBER IS UNAVAILABLE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SEVERAL STAFF MEMBERS EXPERIENCED A BURNING SENSATION ON HANDS WHILE USING LATEX EXAM GLOVES. ONE STAFF MEMBER HAD CUT ON HAND AND DONNED THE GLOVES. THE CUT TURNED INTO A BLISTER. NO MEDICAL TREATMENT REQUIRED. DELAYED SKIN SENTIZATION STUDY ON FILE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IT WAS REPORTED THAT THE DISTAL TIP OF THE FIBER BROKE OFF AND FELL INTO THE PT'S BLADDER. THE PREVIOUSLY PLACED CYSTOSCOPE WAS REMOVED AND REPLACED WITH A LARGER SCOPE. GRASPING FORCEPS WERE INSERTED THROUGH THE LARGER SCOPE AND THE BROKEN TIP WAS RETRIEVED FROM THE PT'S BLADDER WITHOUT ANY FURTHER COMPLICATIONS BEING REPORTED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S PRODUCT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT FELL DOWN WHILE USING FOLDING WALKER. PT WAS ADMITTED TO THE HOSP. NO FURTHER INFO AVAILABLE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CUSTOMER REPORTED THAT A GALLOON OF DEVICE WAS SPILLED IN THE EXAM ROOM. AFTER AN EMPLOYEE CLEANED UP THE SPILLED SOLUTION, THE EMPLOYEE EXPERIENCED EYE IRRITATION CONSISTING OF BURNING, REDNESS AND SWELLING. THE EMPLOYEE WAS SEEN IN THE ER AND GIVEN BACITRACIN OINTMENT FOR THE EYE IRRITATION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DISTRIBUTOR BECAME AWARE ON 2/12/96 OF AN INCIDENT THAT OCCURRED WHILE PERFORMING A PTCA PROCEDURE. DURING THE PROCEDURE THE GUIDE WIRE FROM THE INTRODUCER KIT UNRAVELED AND A PIECE OF THE WIRE DETACHED IN THE PT. THE DETACHED SEGMENT WAS RETRIEVED SUCCESSFULLY AND THERE WERE NO PT COMPLICATIONS INVOLVED. NO FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT ARE AVAILABLE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
AN INCIDENT OCCURRED INVOLVING A RADIAL JAW WHILE PERFORMING A COLONOSCOPY. DIFFICULTIES WERE ENCOUNTERED ACHIEVING CAUTERY DURING THE PROCEDURE, HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT IN INCIDENT. TWO DAYS POST PROCEDURE THE PT RETURNED WITH BLEEDING. A FOLLOW UP COLONOSCOPY REVEALED AN ULCERATED SITE AT THE ORIGINAL SITE OF THE BIOPSY. THE SITE WAS SCLEROSED AND THE PT WAS DISCHARGED TO HOME IN GOOD CONDITION.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE DISCARDED.  THE DEVICE WAS DESTROYED/DISPOSED OF.
CO RECEIVED INFO THAT DURING AN IMPLANT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE PHYSICIAN NOTED UNDERSENSING OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PHYSICIAN ELECTED TO REPOSITION THIS BIPOLAR LEAD DURING A SEPERATE INVASIVE PROCEDURE. THE LEAD WAS REPOSITIONED AND REMAINS IMPLANTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED AN OUT-OF-SVC REMOVAL REPORT WHICH INDICATED THAT THIS LEAD AND ANOTHER WERE REMOVED FROM SVC BECAUSE OF A "LEAD FRACTURE." THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANT DATE 3/25/93. REMOVED FROM SVC 4/29/94. TOTAL IMPLANT TIME 13 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED AN IMPLANT FORM WHICH INDICATED THAT DURING AN IMPLANT PROCEDURE OF THIS BIPOLAR LEAD THE PT'S VENTRICLE PERFORATED AND 150 CC OF BLOOD WAS ASPIRATED FROM THE PERICARDIAL SAC. IMPLANT DATE 9/19/94. REMAINS IMPLANTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) WAS REPLACED BECAUSE OF PREMATURE ELECTIVE REPLACEMENT INDICATORS (ERI). IMPLANTED 3/27/92. EXPLANTED 11/2/94. TOTAL IMPLANT TIME 31 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PHYSICIAN INFORMED CO THAT THIS LEAD AND ANOTHER WERE REMOVED FROM SVC BECAUSE OF A LEAD FRACTURE. IMPLANTED 5/21/92. EXPLANTED 11/11/94. IMPLANTED 29 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED AN OUT-OF-SVC REMOVAL REPORT WHICH INDICATED THAT DURING AN ELECTIVE REPLACEMENT OF AN AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) FOR ELECTIVE REPLACEMENT INDICATORS (ERI), THE PHYSICIAN REMOVED FROM SVC THIS LEAD AND THREE OTHERS. LEADS BECAUSE OF "NONCONVERSION," CO SUBMITTED A SERIOUS INJURY REPORT ON THE TWO 0041 LEADS TO THE FDA ON 12/9/94. IMPLANT DATE 7/22/91. EXPLANT DATE 11/23/94. TOTAL IMPLANT TIME 40 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS LEAD AND ANOTHER WERE EXPLANTED BECAUSE OF INSULATION FAILURE. IMPLANTED 7/11/91. EXPLANTED APPROX 12/1/94. IMPLANTED 40 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PHYSICIAN INFORMED CO THAT THIS LEAD WAS EXPLANTED SHORTLY AFTER IMPLANT AND THAT BLOOD WAS NOTED IN THE INSIDE OF THE INSULATION. IMPLANTED NA. EXPLANTED NA.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT DURING THE CLOSURE OF THE PT'S INCISION, THE PT BECAME ASYSTOLIC. THE PHYSICIAN REOPENED THE INCISION AND NOTED BLOOD INSIDE OF THIS UNIPOLAR LEAD. THE PHYSICIAN ELECTED TO REPLACE THE LEAD.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED AN IMPLANT FORM WHICH INDICATED THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED BECAUSE OF A "SET SCREW DEFECT." IMPLANT DATE 10/11/94. EXPLANT DATE 10/14/94. TOTAL IMPLANT TIME 3 DAYS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AFTER IT "REVERTED TO UNIPOLAR WITH A SHOCK." THE SOURCE OF THE SHOCK WAS NOT STATED AND NO OTHER INFO IS AVAILABLE. IMPLANTED 12/7/92. EXPLANTED 11/8/94. TOTAL IMPLANT TIME 23 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED AN OUT-OF-SERVICE REMOVAL REPORT WHICH INDICATED THAT THIS LEAD AND ANOTHER WERE REMOVED FROM SVC BECAUSE OF NON CONVERSION OF VENTRICULAR FIBRILLATION WITH THESE LEDS. THE PHYSICIAN CAPPED THE LEADS. IMPLANT DATE 2/11/92. REMOVED FROM SVC 11/2/94. TOTAL IMPLANT TIME 32 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED AN IMPLANT FORM WHICH INDICATED THAT THIS LEAD AND ANOTHER WERE REMOVED FROM SVC BECAUSE OF A LEAD INSULATION PROBLEM. THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANT DATE 5/6/92. REMOVED FROM SVC 12/2/94. TOTAL IMPLANT TIME 30 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT A PT WITH AN IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED A COMPLETE LOSS OF CAPTURE. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE TO REPOSITION THIS LEAD WICH WAS DISLODGED. IMPLANT DATE 11/22/94. REMAINS IMPLANTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS LEAD AND ANOTHER WERE REMOVED FROM SVC BECAUSE OF AN INSULATION PROBLEM. THE PHYSICIAN NOTED THAT THE INSULATION WAS WORN AWAY IN THE AREA WHERE THE LEAD RUBBED AGAINST THE AICD, EXPOSING THE WIRE. THE LEADS WILL NOT BE RETURNED FOR ANALYSIS. IMPLANT DATE 12/9/91. REMOVED FROM SVC 11/25/94. TOTAL IMPLANT TIME 36 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED AN OUT-OF-SVC REMOVAL REPORT WHICH INDICATED THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED BECAUSE OF "SENSING DIFFICULTY." IMPLANT DATE 6/28/94. EXPLANT DATE 12/7/94. TOTAL IMPLANT TIME 5 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED AN OUT-OF-SVC REMOVAL REPORT WHICH INDICATED THAT THIS LEAD AN ANOTHER WERE REMOVED FROM SVC BECAUSE OF A "LEAD FRACTURE." IMPLANT DATE 12/22/92. REMOVED FROM SVC 12/9/94. TOTAL IMPLANT TIME 23 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS LEAD EXHIBITED HIGH VENTRICULAR THRESHOLDS. AN INVASIVE PROCEDURE FOUND A "BAD" VENTRICULAR LEAD. THE PHYSICIAN ELECTED TO CAP THIS LEAD AND REPLACE IT WITH ANOTHER. IMPLANTED 6/13/94. REMOVED FROM SVC APPROX 12/16/94. TOTAL IMPLANT TIME 6 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED AN IMPLANT FORM WHICH INDICATED THAT DURING A ROUTINE REPLACEMENT OF AN AICD FOR ELECTIVE REPLACMENT INDICATORS (ERI), THE PHYSICIAN NOTED A "LEAD INSULATION PROBLEM" AND ELECTED TO REMOVE THIS LEAD AND ANOTHER FROM SVC. THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANT DATE 11/19/91. REMOVED FROM SVC 12/7/94. TOTAL IMPLANT TIME 36 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS PT, WHO HAS AN IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED INCREASED PACING THRESHOLDS. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN FOUND A MICRODISLODGEMENT OF THIS BIPOLAR LEAD. THE PHYSICIAN ELECTED TO EXPLANT THE LEAD. THE IPG REMAINS IMPLANTED. IMPLANTED 4/11/94. EXPLANTED 11/11/94. TOTAL IMPLANT TIME 7 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS LEAD AND ANOTHER WERE REMOVED FROM SVC BECAUSE OF A POSSIBLE LEAD FRACTURE. IMPLANTED 12/2/91. REMOVED FROM SVC 11/3/94. TOTAL IMPLANT TIME 35 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SURGEON REMOVED INSERT AND REPLACED WITH INSERT WHICH DID NOT FIT BASEPLATE PROPERLY. A SECOND INSERT WAS THEN PLACED ONTO COMPONENTS WITHOUT INCIDENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DUE TO LOOSE PATELLA AND THIRD PARTY DEBRIS, PLASTIC OF TIBIAL COMPONENT HAS PITTING; REPLACED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TIBIAL POLYETHYLENE WORE THRU WITH ASSOCIATED DULL ACHE FROM POLY DEBRIS. REMOVED EXISTING INSERT (7MM) REPLACED WITH (11MM) NEW INSERT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SMALL POINT CONTACT WEAR WAS VISIBLE SHOWING POTENTIAL WEAR. THE SURGEON REPLACED THE PATELLA COMPONENT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
NON-UNION, REPLACED WITH ANOTHER ROD.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DISASSOCIATION OF POLYETHYLENE FROM METAL BACKING.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR REMOVED THE FEMORAL COMPONENT AND REPLACED IT WITH ANOTHER FEMUR. HE ALSO REPLACED THE PCA MODULAR INSERT AND PATELLA WITH MATCHING COMPONENTS.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PT HAD A TOTAL CONDYLAR KNEE IMPLANTED 11/17/80. THE TIBIA AND INSERT WERE REVISED 7/21/89 WITH A MODULAR BASEPLATE AND A CUSTOM INSERT. THIS BASEPLATE LOOSENED OVER TIME AND WAS MALALIGNED. DR CHOSE TO REMOVE THE BASEPLATE AND INSERT AND REPLACE THEM WITH ANOTHER BASEPLATE AND A CUSTOM INSERT THAT WOULD ARTICULATE WITH THE TOTAL CONDYLAR FEMORAL COMPONENT WHICH WAS WELL FIXED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR REMOVED THE TIBIAL INSERT AND METAL BACKED PATELLA AND REPLACED THEM WITH CO'S 9MM INSERT AND ALL POLY PATELLA.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR REMOVED THE TIBIAL INSERT AND BASEPLATE AND METAL BACKED PATELLA AND REPLACED THEM WITH CO'S MODULAR REVISION COMPONENTS AND A MODULAR ALL POLY PATELLA.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR REMOVED THE TIBIAL INSERT AND BASEPLATE AND METAL BACKED PATELLA AND REPLACED THEM WITH CO'S MODULAR REVISION COMPONENTS AND MODULAR ALL POLY PATELLA.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SURGEON REMOVED AND REPLACED IMPLANT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED BECAUSE IT "REVERTED BACK TO UNIPOLAR DURING SHOCKS." "THE PT ALSO HAS AN AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) IMPLANTED. THE IPG WAS NOT RETURNED FOR ANALYSIS. IMPLANT DATE 8/19/94. EXPLANT DATE 11/22/94. TOTAL IMPLANT TIME 3 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AFTER POSITIONING THE INTRODUCER CATHETER INTO THE PT'S VESSEL AND ATTACHING THE DELIVERY SYSTEM, THE DOME DIDN'T FORM PROPERLY FOR DEPLOYMENT. WHEN THE DOME EXITED THE INTRODUCER SHEATH, THE TIP OF THE DOME TURNED DOWN INSTEAD OF UP. ANOTHER PUNCTURE WAS MADE ALONG SIDE THE INITIAL ENTRY SITE AND A GOOSENECK SNARE WAS USED TO PULL THE DOME'S TIP OUT TO FORM THE DOME CORRECTLY. ONCE THIS WAS DONE, DEPLOYMENT OF THE FILTER WAS COMPLETED TO THE TARGETED LOCATION WITH NO FURTHER COMPLICATIONS REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHILE USING THE FULL ELECTRIC BED, PT FELL BETWEEN THE MATTRESS AND THE SIDERAILS. PT WAS TAKEN TO ER AND RECEIVED X-RAYS. X-RAYS WERE NEGATIVE. UNABLE TO IDENTIFY MFR DUE TO SERIAL NUMBER UNAVAILABLE FOR THE BED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TIBIAL INSERT WAS SEVERELY WORN ON LATERAL/POSTERIOR SIDE. SYNOVIUM WAS PRESENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A TECHNOLOGIST WAS ABLE TO RESULT AND VERIFY AN HBCAB INTERPRETATION PROCEDURE FOR A DONOR UNIT BEFORE SHE HAD VERIFIED THE REPEAT HBCAB RESULTS FOR THAT UNIT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE WIRE, WHICH WAS NOT USED AS THE PRIMARY WIRE, WAS ADVANCED THROUGH A 7 FR CORONARY CATHETER TO THE AORTIC ARCH WHEN MUCH RESISTANCE WAS ENCOUNTERED. THE PT'S ANATOMY WAS EXTREMELY TORTUOUS AND THE WIRE COULD NOT BE ADVANCED ANY FURTHER. DIFFICULTY WAS ENCOUNTERED UPON REMOVAL OF THE WIRE. WHEN PULLED BACK THROUGH THE CORONARY CATHETER A PORTION OF THE COATING SHEARED AND DETACHED IN THE AORTIC ARCH. RETRIEVAL OF THE DETACHED SEGMENT WAS SUCCESSFUL AND THE PT EXPERIENCED NO SEQUELAE AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
THIS DISTRIBUTOR BECAME AWARE ON 12/1/94 OF AN INCIDENT THAT OCCURRED WHILE PERFORMING A CARDIAC CATHETERIZATION. ACCESS WAS GAINED VIA THE LEFT FEMORAL ARTERY WITH AN ENTRY NEEDLE AND THE WIRE WAS ADVANCED THROUGH THE NEEDLE. AN INABILITY TO ADVANCE THE WIRE DUE TO THE PT'S SEVERE VASCULAR DISEASE RESULTED IN REMOVAL OF THE WIRE THROUGH THE ENTRY NEEDLE. UPON REMOVAL A SEGMENT OF THE COATING SHEARED AND DETACHED IN THE GROIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER WIRE. THE PT THEN UNDERWENT SUCCESSFUL SURGICAL REMOVAL OF THE DETACHED COATING. THE PT EXPERIENCED NO SEQUELAE AS A RESULT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE NOT USED AS LABELED/INDENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR REMOVED 7MM TIBIAL IMPLANT THAT WORE OUT AND REPLACED WITH NEW INSERT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE METAL BACKED PATELLA WORE OUT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TUBE WAS PLACED VIA ENDOSCOPY ON 3/14/95. THE PT EXHIBITED SYMPTOMS OF PERITONITIS (FEVER, ABDOMINAL PAIN) ON 4/7/95. THE EXTERNAL BOLSTER HAD NOT ALLOWED FOR FISTULOUS TRACT FORMATION DUE TO THE MANIPULATION OF THE GASTROSTOMY TUBE THOUGHT TO BE CAUSED BY THE INSECURTITY OF THE EXTERNAL BOLSTER. THE PT DIED AT HOME FROM COMPLICATIONS RELATED TO HIS TERMINAL DISEASE. NO AUTOPSY WAS PERFORMED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  3.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  THE DEVICE WAS DESTROYED/DISPOSED OF.
RESUSCITATION EFFORTS WERE IN PROGRESS ON A 2 1/2-MONTH-OLD PT BROUGHT TO ER BY EMS. PT WAS INTUBATED BY PHYSICIAN AND INFANT RESUSCITATION BAG VALVE MASK WAS OBTAINED OFF CRASH CART AND ATTACHED TO OXYGEN HIGH FLOW. IT WAS NOTED THAT NO OXYGEN WAS BEING DELIVERED AND PRESSURE WOULD BUILD UP AND OXYGEN WOULD SHUT OFF AT FLOW HEAD. THAT DEVICE WAS EXCHANGED FOR 2ND BVM WHICH FUNCTIONED CORRECTLY. EMERGENCY MGR EXAMINED FIRST DEVICE AND FOUND 02 TUBING END TO BE SEALED OFF WHICH DID NOT ALLOW FOR DELIVERY OF OXGYEN INTO DEVICE. IT IS NOT BELIEVED THIS INCIDENT ATTRIBUTED TO PT OUTCOME. THE PT DID EXPIRE AFTER RESUSCITATION EFFORTS WERE STOPPED. CORONER TOOK CONTROL OF THE REMAINS AND AN AUTOPSY WAS PERFORMED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  CRITICAL CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  INADEQUATE QUALITY ASSURANCE.  CONCLUSION:  DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
PT HAD A LEFT MASTECTOMY. LEFT MAMMARY IMPLANT WAS SURGICALLY INSERTED ON 4/9/92. PT CONTACTED SURGEON'S OFFICE 11/30/95 TO REPORT THAT SHE HAD NOTED A DECREASE IN THE LEFT BREAST SIZE UPON AWAKENING THAT AM. THE PT WAS SEEN IN HER PHYSICIAN'S OFFICE 12/1/95. MARKED SIZE REDUCTION NOTED IN LEFT BREAST. THE PT WAS SCHEDULED FOR SURGICAL REMOVAL OF THE SPONTANEOUS DEFLATED LEFT BREAST IMPLANT. OR PROCEDURE DONE 12/21/95. IMPLANT FOUND TO BE ALMOST TOTALLY EMPTY WITH NO GROSS RUPTURE OR TEAR NOTED. THE MFR HAS BEEN CONTACTED AND THE IMPLANT IS BEING RETURNED FOR FURTHER FOLLOW-UP/INVESTIGATION BY MFR.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT HAD A PORT INSERTED ON 10/24/95. PT PRESENTED TO ONCOLOGY CLINIC ON 12/14/95 FOR ROUTINE MAINTENANCE/FLUSH. FIRST ATTEMPT BY RN TO FLUSH WAS UNSUCCESSFUL. MD NOTIFED. UROKINASE 5,000 U IV TO PAC INSTILLED. AFTER ONE HR OF WAITING, THE SECOND ATTEMPT TO FLUSH WAS UNSUCCESSFUL. MD WAS AWARE. MD ATTEMPTED TO FLUSH - 2 CC N/S "POP" WAS HEARD BY PT AND NURSE. SKIN BULGED AT PAC AREA. THERE WERE NO SIGNS OR SYMPTOMS OF BLEEDING. SURGEON CONTACTED AND RESPONDED WITHIN TEN (10) MINS. RECOMENDATION BY SURGEON WAS FOR REMOVAL AND REINSERTION OF NEW CATHETER. NEW CATHETER WAS INSERTED ON 12/14/95. SURGEON'S REPORT STATES THAT "ONE OF THE SEPTUMS HAD BECOME DISLODGED FROM THE METAL HOUSING." INFUSION CO WAS MADE AWARE TO INCREASE THE DILUTION RATE AND INCREASE KVO RATE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-DEC-95.  SERVICE PROVIDED BY:  OTHER.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  PORT.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING SURGERY FOR INSERTION OF VENA CAVA FILTER PT WENT INTO CARDIOPULMONARY ARREST RESULTING IN DEATH.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
THE PHYSICIAN INFORMED CO THAT A PT WITH AN AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) RECEIVED INAPPROPRIATE SHOCKS. AN INVASIVE PROCEDURE WAS PERFORMED TO EVALUATE THE SYSTEM. THE PHYSICIAN ELECTED TO CAP BOTH OF THE MYOCARDIAL LEADS AND REPLACE THEM WITH A BIPOLAR ENDOCARDIAL LEAD. THE PT HAD TWO SAME MODEL LEADS. IMPLANTED 7/5/91. REMOVED FROM SVC APPROX 12/28/93. TOTAL IMPLANT TIME 17 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PHYSICIAN INFORMED CO THAT A PT WITH AN AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) RECEIVED INAPPROPRIATE SHOCKS. AN INVASIVE PROCEDURE WAS PERFORMED TO EVALUATE THE SYSTEM. THE PHYSICIAN ELECTED TO REPLACE THE RATE SENSING LEADS. CO ASSUMES THAT THE LEADS WERE CAPPED AND REMAIN IMPLANTED. THE PT HAS TWO SAME MODEL LEADS. IMPLANTED 4/15/93. REMOVED FROM SVC 12/28/93. TOTAL IMPLANT TIME 8 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PHYSICIAN INFORMED CO THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR PREMATURE BATTERY DEPLETION. IMPLANTED 3/27/92. EXPLANTED 11/1/94. IMPLANTED 31 MOS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PATELLA DISLOCATED DURING GOLF SWING.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PLASTIC WORE THROUGH ON THE PATELLA AND TIBIAL INSERT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SAW BLADE BROKE DURING SURGERY ON PATELLA.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ON 11/18/94 CO RECEIVED A REPORT THAT PT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM RESECTION ON 7/29/94 FOR REASONS UNRELATED TO PRODUCT. ON 10/31/94 THE PT HAD ABDOMINAL AORTOGRAM WHICH REVEALED A SURGICAL SPONGE. ON 11/18/94 PT UNDERWENT SURGICAL INTERVENTION FOR SPONGE REMOVAL. PT TOLERATED PROCEDURE AND WAS DISMISSED IN GOOD CONDITION ON 11/23/94.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
MEDICAL SUPPLY HOUSE REPORTED THREE CASES OF SKIN IRRITATIONS WHILE USING LATEX EXAM GLOVES. UNABLE TO CONFIRM WITH THEIR CUSTOMER, NO CLINICAL STAFF AVAILABLE. NO MEDICAL TREATMENT NECESSARY. ACCEPTABLE DELAYED CONTACT SENSITIZATION STUDY ON FILE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
EIGHT STAFF MEMBERS EXPERIENCED RASHES AND BLISTERING WHILE USING LATEX EXAM GLOVES. NO MEDICAL TREATMENT NECESSARY. UNABLE TO IDENTIFY MFR BECAUSE LOT NUMBER WAS NOT PROVIDED AND PURCHASE FROM VARIOUS VENDORS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  8.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
INSERT WORN ON MEDIAL SIDE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
RESIDENT WAS TRANSFERRING HIMSELF TO CHAIR THAT IS ATTACHED TO LIFT DEVICE AND SUSTAINED A LACERATION OF APPROX 3 INCHES TO THE RIGHT LOWER MEDIAL ASPECT OF LEG. HE WAS SENT TO HOSP ER DUE TO ACTIVE BLEEDING. A BLEEDER WAS LIGATED AND WOUND SUTURED AT ER AND WAS STARTED ON ANTIBIOTIC. IN INVESTIGATING THE SITUATION, THE ONLY CAUSE THAT WAS IDENTIFIED WAS CHROME PAINT THAT WAS CHIPPING OFF THE BOTTOM OF THE CHAIR. THIS WAS REPORTED TO THE CO, AWAITING REPSONSE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  EXPECTED WEAR/DETERIORATION.  CONCLUSION:  THERE WAS NO DEVICE FAILURE.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
OR FIELD LIGHT WAS BEING REPOSITIONED INTRAOPERATIVELY BY DR. WHEN LIGHT HOUSING MADE CONTACT WITH IV POLE, GREASE CAP FELL OFF LIGHT ONTO STERILE FIELD. THERE APPEARS TO BE A DESIGN PROBLEM: #1 GREASE CAP SPRINGS APPEAR TO ONLY HOLD CAP ON BY TENSION. POSSIBLY THERE SHOULD BE A GROOVE IN THE HOUSING FOR THE SPRING TO SIT IN. #2 SAFETY CABLE ATTACHMENT SCREW EYE BROKE NEAR HOLE. SCREW EYE APPEARS TO BE TOO LARGE FOR SCREW. NO HARM TO PT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-JAN-93.  SERVICE PROVIDED BY:  USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT.  SERVICE RECORDS AVAILABLE.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  DESIGN - INADEQUATE.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE REPAIRED AND PUT BACK IN SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
REQUIRED RE-PROGRAMMING THE DEVICE TO RECOGNIZE AND TREAT BOTH VENTRICULAR TACHYCARDIA AND FIBRILLATION. AN AUTOMATIC INTERNAL CARDIOVERTER DEFIBRILLATOR FAILED TO SENSE AND TREAT A TACHY VENTRICULAR DYSRHYTHMIA WITH A RATE OF 195. THE PT HAD TO BE EXTERNALLY DEFIBRILLATED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PT PROCEDURE WAS AN EMBOLIZATION OF RIGHT ACOM ANEURYSM. WHILE USING THE INTRODUCER CATHETER, THE FIRST COIL DETACHED WITHOUT INCIDENT. THE 2ND COIL BECAME LOOSE FROM WIRE PRIOR TO PLANNED DETACHMENT, COIL PARTIALLY IN ANEURYSM AND PARTIALLY IN GUIDING CATHETER OUTSIDE OF ANEURYSM. COIL RETRIEVED, PACKAGING INFO SAVED AND MFR NOTIFIED. CO REP PICKED UP COIL AND PACKAGING INFO ON 2/20/96.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  2.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AFTER POSITIONING THE INTRODUCER CATHETER INTO THE PT'S VESSEL AND ATTACHING THE DELIVERY SYSTEM, THE FILTER GOT STUCK INSIDE THE STORAGE TUBE AND COULDN'T BE ADVANCED INTO THE INTRODUCER CATHETER. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT TO COMPLETE THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
RPTR INDICATES A 73-YR-OLD FEMALE WITH SWALLOW IMPAIRMENT ON TUBE FEEDING WAS FOUND IN ACUTE DISTRESS WITH PROJECTILE VOMITTING. REPORTEDLY, THE TUBING CAME OFF THE ROTOR ON THE PUMP AND PT RECEIVED 1000 CC OF FORMULA OVER 1 HR AND 15 MINS. THERE WAS NO ASPIRATION.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHILE PLACING A NEEDLE IN CONTAINER, NURSE GRAZED HER HAND ON A NEEDLE THAT WAS STICKING OUT OF CONTAINER. NURSE UNDERWENT HIV, HEPATITIS, AND RECEIVED A GAMMA GLOBULIN SHOT. NO FURTHER TREATMENT RECEIVED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT WAS AN 84-YR-OLD WOMAN WHO WAS DIALYZING. IT WAS NOT HER FIRST TREATMENT ON THE DIALYZER. THE DIALYZER WAS PRIMED ACCORDING TO MFR'S DIRECTIONS AND WAS NOT RE-USED. THE PT COMPLAINED OF INCREASING PRUITIS WHICH HAD OCCURRED MILDLY DURING HER TWO PREVIOUS TREATMENTS. HER VITAL SIGNS, BP 155/55, P-76, REMAINED STABLE. SHE EXPERIENCED NO OTHER SYMPTOMS, OTHER THAN A MILD RASH APPROX 2 HRS LATER. SHE WAS GIVEN BENADRYL 25MG PO WHICH GAVE HER SOME RELIEF FROM THE ITCHING. HER DIALYZER WAS SWITCHED PRIMED USING BEEF HEPARIN, AND SHE HAS NOT HAD ANY RECURRENCE. SHE IS ON PROCARDIA XL 60MG FOR CONTROL OF HYPERTENSION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
19 MM AORTIC VALVE (MECHANICAL), LOST A LEAFLET WHILE IMPLANTING. REPLACED WITH A DIFFERENT AORTIC VALVE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  LEAFLET.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A 39-YR-OLD FEMALE HAD SILICONE BREAST IMPLANTS PLACED 10/77, NOW DESIRING REMOVAL DUE TO PAINFUL CAPSULAR CONTRACTURE, BILATERAL GRADE III BREAST CONTRACTURES. BOTH IMPLANTS INTACT UPON REMOVAL. NO IDENTIFYING MARKS NOTED ON IMPLANTS.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
A 40-YR-OLD FEMALE HAD BILATERAL SILICONE GEL IMPLANTS IN 4/90 AT ANOTHER FACILITY. THE PT IS EXPERIENCING NECK AND BACK PAIN BELIEVED TO BE SECONDARY TO THE IMPLANTS. THE PATHOLOGY REPORT INDICATES CHRONIC INFLAMATION, LOCAL FOREIGN BODY REACTION AND CAPSULAR CONTRACTURES.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
ON 8/6/93 AT 1330, RESIDENT WAS SITTING UP IN A W/C WITH A LAP TRAY IN PLACE, WHEN RESIDENT FELL TO FLOOR. RESIDENT SUFFERED A 2 INCH LINEAR LACERATION ON RIGHT FOREHEAD, BLEEDING FROM RIGHT NOSTRIL AND A NON-DISPLACED FRACTURE AT BASE OF LEFT THUMB, TO BE FOLLOWED BY AN ORTHOPEDIST. AFTER FALL, IT WAS NOTED THAT THE VELCRO STRAPS ATTACHED TO THE LAP TRAY HAD COME LOOSE. AFTER DETERMINATION THAT THE LAP TRAY HAD BEEN PROPERLY APPLIED; CLOSER INSPECTION OF LAP TRAY REVEALED WASHERS MISSING FROM SCREWS SECURING THE VELCRO STRAP WHICH HAD COME LOOSE. THE STRAP CAME OFF THE SCREWS, CAUSING LOOSENING OF THE WHOLE LAP TRAY, AND SUBSEQUENTLY LED TO RESIDENT'S FALL. ALL LAP TRAYS OF THIS TYPE WERE IMMEDIATELY REMOVED FROM USE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  MATERIAL DEGRADATION/DETERIORATION.  CONCLUSION:  DEVICE FAILURE DIRECTLY CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
RESIDENT WAS IN ROOM IN THE WHEELCHAIR. THE RESIDENT TRIED TO TURN HER WHEELCHAIR AROUND WHILE THE BRAKE WAS ON. THE CHAIR TIPPED TO THE SIDE. THE SIDE OF THE WHEELCHAIR CAME AWAY FROM THE SEAT OF THE CHAIR. THE CHAIR WAS INSPECTED AND FOUND THE MECHANISM WHICH ALLOWS THE CHAIR TO BE FOLDED UP AND DOWN HAD COME OFF THE TRACK. THE CHAIR WAS REMOVED FROM SVC.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  OTHER.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  COMPONENT FAILURE, TELEMETRY FAILURE.  CONCLUSION:  DEVICE FAILURE DIRECTLY CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
RESIDENT SUSTAINED MINOR INJURIES WHEN LIFT TIPPED OVER WITH RESIDENT BEING TRANSFERRED TO CHAIR FROM BED BY SINGLE CERTIFIED NURSING ASSISTANT. RESIDENT WAS TAKEN TO ER. X-RAYS NEGATIVE. RESIDENT SUFFERED MINOR SKIN TEAR ON HAND. INCIDENT OCCURRED 8/1/94.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-NOV-94.  SERVICE PROVIDED BY:  USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  INCORRECT TECHNIQUE/PROCEDURE.  CONCLUSION:  USER ERROR CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  USER EDUCATION PROVIDED.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
SIDERAIL ON LEFT SIDE OF BED NEAR DOOR AND HEAD OF BED GAVE AWAY WHILE RESIDENT WAS TURNED TOWARD SIDERAIL WHILE AM CARE BEING GIVEN. LACERATION NOTED TO LP SIDE OF FOREHEAD, ABOVE LEFT EYE AND LEFT SIDE OF HEAD.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  COMPONENT FAILURE, MANUFACTURING.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  INVALID DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ON 11/26/93, PT HAD CATHETER INSERTED. PT EXPERIENCED PARALYSIS TO BOTH LEGS IN PAR. PT EVALUATED 11/26/93. PT RETURNED TO SURGERY ON 11/29/93 FOR EXTRACTION OF EPIDURAL CATHETER. PT CAME DOWN TO SURGERY WITH PORTION OF CATHETER REMOVED WHICH IS THE OUTSIDE PORTION OF DEVICE. A DRESSING WAS NOTED AT THE SITE. CATHETER WAS EXTRACTED THROUGH THE SAME LUMBAR INCISION USED FOR INSERTION. CATHETER WAS EXTRACTED IN ITS ENTIRETY. BACITRACIN 50,000 U/1000CC NACL USED FOR IRRIGATION. PT MOVING FEET, WIGGLING TOES, ROTATING LEGS LATERALLY AND MEDIALLY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE TEMPORARILY REMOVED FROM SERVICE.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
PT A: FRACTURE WAS SUSPECTED, HOWEVER PROTRUSION OF WIRE SEGMENT IS NOT SUSPECTED. REPORT STATUS: DUAL FRACTURES OF LEAD WITH CATEGORIZATION OF THE PROXIMAL LESION GROUP 2-3 OR MORE DISTAL LESION GROUP 2. PT B: FRACTURE WAS SUSPECTED HOWEVER PROTRUSION OF WIRE SEGMENT IS NOT SUSPECTED. REPORT STATUS: GROUP 2-3 FRACTURE OF ACCUFIX ATRIAL J LEAD. ACTION: BOTH PTS HAVE DISCUSSED WITH THEIR PHYSICIAN POSSIBLE INTERVENTIONS. DECISIONS ARE PENDING AND THE PTS ARE STABLE AT THIS TIME. REPEAT SCREENING IS SCHEDULED FOR EVERY SIX MONTHS.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  2.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SURGERY FOR REMOVAL OF BREAST IMPLANT PERFORMED ON 8/26/93. RIGHT BREAST IMPLANT RUPTURED. IMPLANTED 2/28/78.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
RESIDENT WAS FOUND DEAD AT 4:30 AM KNEELING BESIDE BED WITH UPPER TORSO BETWEEN UPPER AND LOWER SIDE RAILS FACING OUT INTO ROOM. HER DIAPHRAGM/THORACIC AREA WAS WEDGED BETWEEN UPPER SIDE RAIL AND SIDE OF BED AND MATTRESS. HEAD AND NECK WERE WELL ABOVE SIDE RAIL.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  .  SERVICE PROVIDED BY:  OTHER.  SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
THE PT WAS UNDERGOING AN ATTEMPTED ANGIOPLASTY. THE BALLOON WAS ADVANCED WITH SOME DIFFICULTY TO THE REGION OF, BUT NOT ACROSS, THE STENOTIC REGION. WITH ATTEMPTS TO WITHDRAW THE BALLOON SOMEWHAT AND REPOSITION THE GUIDING CATHETER, SOME RESISTANCE WAS MET AND A SNAP WAS FELT. AT THIS TIME, THE EXTERNAL BALLOON SHAFT COULD BE MOVED EASILY WITHOUT ANY APPARENT MOVEMENT OF THE BALLOON MARKER. A SURGICAL CONSULTATION WAS OBTAINED, AND IT WAS DECIDED THAT THE BEST OPTION FOR THE PT WAS OPEN HEART SURGERY FOR REMOVAL OF THE FOREIGN BODY AND REVASCULARIZATION.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IT WAS REPORTED THAT DURING A BPH PROCEDURE, THE FIBER TIP BURNED UP, DETACHED FROM THE FIBER SHAFT AND REMAINED IN PT'S BLADDER. GRASPING FORCEPS WERE USED THROUGH THE PREVIOUSLY PLACED CYSTOSCOPE TO RETRIEVE THE DETACHED TIP. NO FURTHER COMPLICATIONS WERE REPORTED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE SURGEON ATTEMPTED TO IMPACT THE INSERT INTO THE IMPLANTED ACETABULAR SHELL AND THE INSERT DID NOT LOCK SECURELY INTO THE SHELL. ANOTHER INSERT OF THE SAME TYPE WAS OPENED AND IMPACTED SECURELY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT WAS FOUND ON FLOOR NEXT TO HIS BED WITH AGONAL RESPIRATIONS, SURROUNDED BY A POOL OF BLOOD ABOUT HIS HEAD AND BODY, APPROX 2-3 L. THE SHEATH IN PT'S RIGHT INTERNAL JUGULAR VEIN FOUND TO BE LOOSE WITH BLOOD EXSANGUINATING. THE SHEATH WAS RECAPPED/SCREWED BACK ON IMMEDIATELY. CPR WAS INITIATED WITH ALL MEASURES TAKEN. AFTER APPROX 50 MINS, PT WAS ASYSTOLIC AND PRONOUNCED DEAD. THE PT AND INTRODUCER SHEATH (IV LINE) WERE OBSERVED WITH NO PROBLEMS NOTED 28 MINS PRIOR TO THIS EVENT. TPN HAD BEEN INFUSING IN THIS LINE WITH NO PRIOR LEAKAGE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  A DEVICE FROM SAME LOT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
DRAIN IMPLANTED FOR TEMPORARY USE 4/1/94. ATTEMPTED TO REMOVE DRAIN ON 4/4/94, DRAIN BREAK. PORTION OF DRAIN REMAINED IN PT. PT RETURNED TO SURGERY ON 4/4/94 TO ATTEMPT TO REMOVE REMAINING PORTION OF DRAIN.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  NONE OR UNKNOWN.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS DESTROYED/DISPOSED OF.
FLUID EXTRAVASATION INTO SUBCUTANEOUS TISSUE NECESSITATING PT INTUBATION AND ADMISSION TO INTENSIVE CARE UNIT.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
COUCH WOULD NOT RETRACT FROM RADIATION UNIT UPON COMPLETION OF TRETMENT. PT REMOVED MANUALLY FROM SYSTEM.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-AUG-94.  SERVICE PROVIDED BY:  INVALID DATA.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED.  RESULTS OF EVALUATION:  COMPONENT FAILURE.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE REPAIRED AND PUT BACK IN SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A 7 CM PIECE OF PLASTIC FOUND INSIDE ABDOMEN DURING LAPAROSCOPIC SURGERY. SURGERY WAS TO REMOVE THIS FOREIGN OBJECT. UNABLE TO DETERMINE ORIGIN AT THIS TIME.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
MEDICAL EXAMINER'S REPORT RECEIVED 3/11/96 CITING DEATH AS A RESULT OF HEMOPERICARDIUM WITH CARDIAC TEMPONADE DUE TO PERFORATION OF THE RIGHT ATRIUM AND AORTA BY STENT FOLLOWING EMBOLIZATION FROM THE LIVER DURING INSERTION. THE MEDICAL EXAMINER'S REPORT STATES EXAMINATION OF THE END OF THE STENT REVEALED DIMENSIONS CONSISTENT WITH INJURIES OF THE RIGHT ATRIUM AND AORTA. MEDICAL EXAMINER'S OFFICE DENIED REQUEST FOR RETURN OF THE STENT TO HOSP.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DEVICE DID NOT ALARM PROPERLY. PT DID NOT RECEIVE MEDICATION ON 10/1/95.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  DEVICE FAILED DURING ASSEMBLY.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
BURN OF SCLERAL TUNNEL WOUND (WITH DISSOLUTION  OF PORT OF SCLERAL TUNNEL WOUND ROOF, AND YET A NICELY SELF-SEALING WOUND) DUE TO PHACOEMULSIFIER, DURING CARATACT SURGERY. SUSPECT THIS WAS DUE TO A FOLD-OVER OF TISSUE FLAP WITHIN THE SCLERAL TUNNEL, COMPRESSING THE TIP INFUSION SLEEVE. THE ONLY HARM DONE IS ON INCREASED AMOUNT (8-10 DIOPTERS) OF PLUS-CYLINDER ASTIGNATION BY 90 DEGREES, WHICH IS BELIEVED TO BE TEMPORARY BUT LIKELY WILL HAVE AN EFFECT (MAINLY THICKER EYEGLASSES TO CORRECT THE ASTIGNATION) FOR 1-2 YEARS AFTER SURGERY. ALSO OCCURRED IN A 69-YR-OLD PT 2/6/96 BELIEVED TO BE FOR THE SAME REASONS, THOUGH NO DISSOLUTION OF SCLERAL ROOF OCCURRED, BUT WOUND REQUIRED SUTURING RATHER THAN BEING SELF-SEALING.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  2.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-OCT-95.  SERVICE PROVIDED BY:  USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN, OTHER, UNANTICIPATED.  CONCLUSION:  NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BURN OF SCLERAL TUNNEL WOUND (REQUIRING SUTURES FOR CLOSURE RATHER THAN BEING SELF-SEALING AS INTENDED) DUE TO PHACOEMULSIFIER, DURING CATARACT SURGERY. SUSPECT THIS WAS DUE TO A FOLD-OVER OF TISSUE FLOP WITHIN THE SCLERAL TUNNEL, COMPRESSING THE TIP INFUSION SLEEVE. THE ONLY HARM DONE IS AN INCREASED AMOUNT (8-10 DIOPTERS) OF PLUS-CYLINDER ASTIGNATION BY 90 DEGREES, WHICH IS BELIEVED IS TEMPORARY BUT LIKELY WILL HAVE AN EFFECT (MAINLY THICKER EYEGLASSES TO CORRECT THE ASTIGMATISM) FOR 1-2 YEARS AFTER SURGERY. ALSO OCCURRED IN AN 86-YR-OLD LADY 11/21/95, BELIEVED FOR THE SAME REASONS, BUT WITH DISSOLUTION OF THE SCLERAL NOOB AND YET THE WOUND WAS NICELY SELF-SEALING.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  2.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-OCT-95.  SERVICE PROVIDED BY:  USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN, OTHER, UNANTICIPATED.  CONCLUSION:  NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  OTHER.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
PT WAS A FORTY-FOUR-YR OLD, WHITE MALE, WITH HISTORY OF ITP FOR 6 MONTHS, POST-SPLENECTOMY AND FAILED IVIG THERAPY. HE ALSO HAD A HISTORY OF HODGKINS DISEASE. DURING PRESENT HOSPITALIZATION HE WAS INITIALLY ADMITTED FOR EVALUATION AND TREATMENT OF POSSIBLE ABDOMINAL BLEED AND SEPSIS. ATTENDING PHYSICIAN REQUESTED INITIATION OF IMMUNOABSORPTION THERAPY ON 11/28/94. CENTRAL LINE PLACEMENT WAS FIRST ATTEMPTED ON 11/28/94 WITHOUT SUCCESS, CAUSING DELAY IN TREATMENT SCHEDULE UNTIL 11/29/94. PT WAS NOT TAKING ANY ACE INHIBITORS. TREATMENTS ON 11/29/94 AND 12/1/94 WERE COMPLETED WITHOUT INCIDENTS. PT TOLERATED BOTH TREATMENTS WELL AND WAS STABLE THROUGHOUT. INITIALLY PLATELETS WERE IN THE RANGE OF 4,000 WITH COUNT UP TO 71,000 ON 12/1/94. PT WAS ALSO RECEIVING PLATELET TRANSFUSIONS DURING THIS HOSP STAY. HOWEVER, DUE TO NASAL SEPTAL BLEEDING, NASAL PACKING TWICE WAS NECESSARY. ON 12/3/94 TREATMENT WAS BEGUN AS USUAL. FLOOR RN INDICATED PT HAD BEEN MEDICATED WITH ORAL PAIN MEDICATIONS, M.S.WMGIV, AND ATIVAN PRIOR TO PROCEDURE. FIFTEEN MINS INTO PROCEDURE, PT BECAME DIAPHORETIC AND BP HAD DROPPED TO 83/46. AT THIS TIME PT ALSO HAD SMALL EMESIS OF DARK BLOOD AND COMPLAINED ABDOMINA PAIN. TREATMENT WAS STOPPED AND ATTENDING PHYSICIAN WAS NOTIFIED ALONG WITH MEDICAL DIRECTOR. RPTR WAS ADVISED TO DISCONTINUE TREATMENT IF SYSTOLIC BP WAS BELOW 100. DR ORDERED 0.9NS 500ML BOLUS TO BE GIVEN AND STAT CBC DRAWN. AFTER BOLUS GIVEN, DR WAS ADVISED OF BP 114/72; P117, R22. PROCEDURE WAS ORDERED TO RESUME. H&H REPORTED UNCHANGED FROM INIITAL AM VALUE ON 12/3/94. PROCEDURE WAS RESUMED BUT AT SLOWEST POSSIBLE RATE (PLASMA PUMP SET AT 10ML/MIN). PT'S BP AGAIN DROPPED BELOW 100 SYSTOLIC AND PROCEDURE WAS ABORTED WITH RINSEBACK COMPLETED (NOT VIA COLUMN). DOCTORS INFORMED OF TERMINATION OF PROCEDURE. FOLLOWING END OF PROCEDURE, PT WAS TRANSFERRED TO ICU; SCANS WERE TO BE PERFORMED. PT ARRESTED AND EXPIRED IN ICU AT 2242 (12/3/94). NO AUTOPSY WAS PERFORMED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  CRITICAL CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  .  SERVICE PROVIDED BY:  FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  MAYBE.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS DESTROYED/DISPOSED OF.
PATELLA IMPLANT HAD BEEN SEPARATED FROM BONE SINCE 10/93. PATELLA IMPLANT WAS NOT REPLACED DUE TO LACK OF ADEQUATE BONE STOCK. THIS WAS OLDER STYLE PATELLA PROSTHESIS WITH ONLY TWO SHORT PEGS. THIS TIBIAL INSERT WAS ROUTINELY REPLACED EVEN THOUGH THE ORIGINAL SHOWED VERY LITTLE WEAR. THE PT'S PAIN WAS ALL DUE TO "FLOATING" PATELLA IMPLANT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TIBIAL COMPONENT LOOSENED AT CEMENT INTERFACING.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT COMPLAINED OF PAIN AND INSTABILITY. X-RAYS REVEALED INSERT WEAR AND PATELLA LOOSENING.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR DETERMINED THE STEM TO BE LOOSE SO HE REPLACED IT. HE ALSO REPLACED THE ACETABULAR INSERT AT THE SAME TIME.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR DETERMINED THE PATELLA TO BE LOOSE SO HE REPLACED IT. HE ALSO REPLACED THE TIBIAL INSERT AT THE SAME TIME.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR DETERMINED THE STEM TO BE LOOSE SO HE REPLACED IT. HE ALSO REPLACED THE ACETABULAR INSERT AT TEH SAME TIME.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A 60-65-YR-OLD FEMALE, PRESENTED FOR HEMOSTASIS OF A STOMACH BLEEDER. THE PROBE WAS PLACED DOWN AN ENDOSCOPE AND INTO THE SITE. CAUTERY SETTINGS OF 2 CUT/2 COAG WERE APPLIED WITH DIRECT TAMPONADE, AND NO COAGULATING ACTION WAS ACHIEVED. THE PHYSICIAN PLACED THE PROBE AS A TEST ON UNAFFECTED MUCOSA AND COAGULATING ACTION WAS NOTED. REPEATED PLACEMENT, AND WITH THE SIDE OF THE PROBE PLACED INTO THE AFFECTED BLEEDER, INCREASED SETTINGS TO 5/5, AND A STOMACH WALL PERFORATION OCCURRED. THE PROCEDURE WAS STOPPED AND THE PT UNDERWENT A SURGICAL RESECTION OF THE STOMACH WALL. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PT HAS BEEN DISCHARGED FROM THE HOSP.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH AN ICD AND TWO (RATE SENSING) LEADS HAD EXPERIENCED OVERSENSING/INAPPROPRIATE SHOCKS. THE PHYSICIAN ELECTED TO CAP AND REPLACE BOTH LEADS. IMPLANTED 7/20/92. CAPPED AND REMOVED FROM SVC 2/8/96. IMPLANTED 42 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING THE ROUTINE REPLACEMENT OF AN ICD THE TWO UNIPOLAR (RATE SENSING) LEADS WERE FOUND TO EXHIBIT POOR PACING THRESHOLDS AND INADEQUATE SENSING. THE PHYSICIAN ELECTED TO CAP THE TWO LEADS AND IMPLANT A NEW BIPOLAR (RATE SENSING) LEAD. IMPLANTED 9/25/92. OUT OF SVC 12/6/95 (INSERVICE 38 MONTHS).INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THESE LEADS EXHIBITED INAPPROPRIATE SHOCKS. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THESE LEADS. IMPLANT DATE 5/4/92, EXPLANT DATE 3/19/96. TOTAL IMPLANT TIME 46.5 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED INAPPROPRIATE SHOCKS 4 DAYS AFTER A ROUTINE BATTERY CHANGEOUT. AN INVASIVE PROCEDURE WAS PERFORMED AND THE SURGEON NOTED THAT THE LEADS WERE INADVERTENDLY NICKED DURING THE ICD CHANGEOUT. A NEW RATE SENSING LEAD WAS IMPLANTED. IMPLANT DATE 4/3/92, EXPLANT DATE 2/22/96. TOTAL IMPLANT TIME 46.6 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
RADIOGRAPH SHOWS OSTEOLYSIS REVISION SURGERY REQUIRED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THORACENTESIS OVER RIGHT INTERCOSTAL SPACE. APPARENTLY, THE CATHETER WAS PULLED BACK THROUGH THE NEEDLE AS IN OTHER BRANDS. CT SCAN REVEALED "SHEARED CATHETER" ON 11/21/95. SURGICALLY REMOVED. PT DID FINE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  USER EDUCATION PROVIDED.  THE DEVICE WAS DESTROYED/DISPOSED OF.
TMJ IMPLANTS REMOVED BILATERALLY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  OTHER.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT WAS RECEIVING A BATH. THE PT WAS SECURED BY THE TWO LIFT STRAPS. THE TROLLEY CHAIR WAS LIFTED OUT OF THE WHIRLPOOL. (USING REMOTE CONTROL). STAFF WAS STANDING ON THE RIGHT SIDE OF THE TUB. THE PT BECAME SPASTIC AND THE BELTS POPPED OFF. PT FELL OFF TROLLEY ONTO THE FLOOR. (ON THE LEFT SIDE).DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  DESIGN - INADEQUATE, DESIGN - HUMAN FACTORS.  CONCLUSION:  DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
PT ON DIALYSIS FOR APPROX ONE MIN. BLOOD NOT RETURNED DUE TO LARGE LEAK INDICATED BY REAGENT STRIP. LOSS ESTIMATED AT 250CC.
PICC LINE OCCLUDED. UROKINASE INSTILLED WITHOUT RESULT. ORDER TO DISCONTINUE PICC LINE, WHEN REMOVED, APPROX 10 INCHES WAS RETAINED IN THE PT. REQUIRED SURGICAL REMOVAL. FINAL PROBLEM DETERMINED THAT INTIMA OR VEIN TELESCOPED ONTO CATHETER WHILE BEING WITHDRAWN.
ON 10/26/95, THE PT, WHO HAD A THREE MONTH HISTORY OF ABDOMINAL PAIN AND WAS SUBSEQUENTLY DIAGNOSED WITH CHOLECYSTITIS UNDERWENT A LAPAROSCOPIC LASER CHOLECYSTECTOMY. DURING THE PROCEDURE, THE JAW ON THE LAPAROSCOPIC FORCEPS BROKE. THE PT REQUIRED A MINI LAPAROTOMY TO REMOVE THE BROKEN PIECE.
TPN LEAKED THROUGH CATHETER CAUSING SWELLING OF THE ANTERIOR CHEST WALL IN RECOVERY. DEFECTIVE CATHETER.
COMPLAINANT IS REGULATORY AFFAIRS MGR FOR ABOVE FIRM. A MARKETING REP FROM THE SAME FIRM WAS AT A "NATIONAL ABORTION FEDERATION MEETING" ON 3/31 - 4/1/96. THE REP FOUND A FIRM ADVERTISING THE CERVICAL DILATOR. COMPLAINANT SAID THAT THE MFR OF THIS PRODUCT WAS PERMANENTLY ENJOINED FROM SELLING THIS PRODUCT BY FEDERAL COURT ON 3/28/95. (*)
BOSTON SCIENTIFIC CORP. 480 PLEASANT ST, WATERTOWN, MA 02172. NO OTHER INFO HAS BEEN PROVIDED AND OUR INVESTIGATION INTO THIS MATTER HAS PROVEN UNSUCCESSFUL. NO FURTHER DETAILS ARE AVAILABLE. THIS MFR CONSIDERS THIS COMPLAINT/MDR CLOSED.
COMPLAINANT BELIEVES RESULTS ARE READING LOWER THAN THEY SHOULD.
COMPLAINANT IS HANDICAPPED AND USES A THREE-WHEELED ELECTRIC SCOOTER. THIS IS DESIGNED FOR USE BY HANDICAPPED PERSONS. ON TWO OCCASIONS IT BEGAN MOVING WHILE THE THROTTLE WAS IN THE STOP POSITION. THE SECOND TIME THIS OCCURRED IN A SHOPPING MALL AND HE RAN INTO A DOOR AND SUFFERED A STRAINED BACK AND NECK. A BOOKLET WHICH CAME WITH THE SCOOTER STATED THAT RADIO WAVES MAY INTERFERE WITH THE OPERATION OF THIS PRODUCT.
CONSUMER'S WIFE HAD MFR'S MECHANICAL HEART MITRAL VALVE IMPLANTED IN 1988. IN 1995 SHE BEGAN TO HAVE SYMPTOMS SUCH AS WEAKNESS, BLOOD IN THE URINE, ETC, AND IN 6/95 THE VALVE WAS REMOVED. THE SURGEON WHO REMOVED THE VALVE TOLD THE CONSUMER THAT IT HAD FAILED. IT WAS SENT BACK TO THE MFR AND IN 1/96 THE CONSUMER RECEIVED A LETTER FROM THE MFR STATING THAT HE WOULD NOT BE ABLE TO RECEIVE ANY MONETARY AWARD BECAUSE THE EVALUATION REPORT FOUND NOTHING WRONG WITH THE VALVE AFTER A VISUAL TEST WAS CONDUCTED. CONSUMER SAID HE WANTED TO TRY TO SETTLE OUT OF COURT AND ASKED HIS WIFE'S SURGEON FOR ADVICE. THE SURGEON TOLD HIM THAT HE SHOULD HAVE THE VALVE MEASURED BY A THIRD/NEUTRAL PARTY.
COMPLAINANT REPORTS THAT UPON USING SUBJECT DEVICE'S ATTACHMENT WHICH SHE DESCRIBED AS A "PICK," "WIRE," OR "FLOSS" BRUSH, IT BECAME STUCK BETWEEN HER TOOTH AND GUM CAUSING HER RECURRING PAIN AND WHAT HER DENTIST DESCRIBED AS "IRREPARABLE BONE DAMAGE."
WHILE HAVING A CHOLECYSTECTOMY AND EXPLORATION OF THE COMMON DUCT, THE COVERING OF THE CHOLEDOCOSCOPE SPLIT AND SEPARATED AS THE PROCEDURE PROGRESSED. THE SURGICAL SITE WAS IRRIGATED AND ALL PARTICLES RETRIEVED. FACILITY HAD TWO SUCH SCOPES, BOTH WERE REMOVED FROM SVC AND RETURNED TO THE MFR. UPON EXAMINATION, THE COATING ON THE SECOND SCOPE WAS CRACKED. AS THIS WAS ACCOMPLISHED WITHOUT THE SPECIFIC SCOPE IDENTIFIED PRIOR TO SHIPPING, BOTH SCOPES SERIAL NUMBERS ARE INCLUDED IN THIS REPORT.
PT SUSTAINED FIRST AND SECOND DEGREE BURNS OF BACK OF NECK FOLLOWING MRI OF C-SPINE. PT WAS WEARING A SILK BLOUSE, NO NECKLACE OR BRA. MFR CHECKED EQUIPMENT ON SITE POST-OCCURRENCE AND FOUND NO PROBLEM WITH COIL; NOTED METAL ARTIFACT ON ALL SCANS. PT RECEIVED OUTPATIENT MINOR TREATMENT.
PENILE PROSTHESIS (14 CM) IMPLANTED 9/27/94. BEGAN EXPERIENCING DIFFICULTY WITH THE FUNCTIONING OF THE PROSTHESIS IN 1/95. CONSERVATIVE MEASURES TAKEN TO IMPROVE FUNCTION OF PROSTHESIS AT THAT TIME. THE PROBLEMS CONTINUED AND THE PHYSICIAN FELT THEY WERE THE RESULT OF A FILLING DEFECT AND POSSIBLY  VALVE FAILURE, RESULTING IN THE EXPLANTATION AND REIMPLANTATION OF A PENILE PROSTHESIS.
PT HAD A REPEAT SWEAT CHLORIDE TEST PERFORMED ON HIS LEFT ARM. WHEN THE NEGATIVE ELECTRODE WAS REMOVED A DIME-SIZED REDDENED AREA WITH A 1MM BURN IN THE CENTER WAS NOTED. THE DISC UNDER THE NEGATIVE ELECTRODE WAS PULLING AWAY AT THE EDGES AND WAS CRACKED. PT WAS EVALUATED BY A MD AND THE SITE WAS DESCRIBED AS A 1MM DIAMETER 2ND DEGREE BURN WITH AN APPROX DEPTH OF 0.5MM.
THE PT WAS HAVING A CHOLECYSTECTOMY. THE DECISION WAS MADE TO CONVERT FROM CLOSED APPROACH TO OPEN. ACCORDINGLY, THE FIBEROPTIC LIGHT CARRIER WAS DISCONNECTED FROM THE CAMERA AND PLACED ON THE PT'S DRAPE. THE ANESTHESIOLOGIST NOTED TWO SMALL SUPERFICIAL BURNS (1 CM EACH) ON THE PT'S LEFT NECK.
SECOND ATTEMPTED LUNG BIOPSY (7/19/95 - 1ST ATTEMPT RESULTED IN 30% PNEUMOTHORAX AND INSERTION OF A CHEST TUBE. AS THE RADIOLOGIST WAS WITHDRAWING THE BIOPSY NEEDLE, IT BROKE OFF LEAVING ABOUT 5 CM OF THE NEEDLE WITHIN THE CHEST. "NEEDLE FOUND LYING IN CLOSE PROXIMATION TO THE AORTA IN POSTERIOR THORACIC REGION." THE RADIOLOGIST MADE AN INCISION INTO THE SKIN AND ATTEMPTED TO GRAB IT WITH HEMOSTATS. HE WAS ABLE TO OBTAIN 6 MM OF THE NEEDLE WHEN IT BROKE OFF A 2ND TIME AND RECOILED FURTHER INTO THE CHEST. PT REQUIRED SURGERY FOR THE REMOVAL OF THE NEEDLE AND LUNG BIOPSY. SURGERY 7/21/95 FOR REMOVAL OF NEEDLE AND LEFT LOWER LOBE LOBECTOMY DUE TO + FROZEN SECTION FOR CANCER.
PT HAD INSERTION OF INFLATABLE PENILE PROSTHESIS IN 9/93. FAILURE OF PROSTHESIS TO INFLATE, MALFUNCTION OF 100C POUCH RESERVOIR.
AFTER INSERTION OF MULTI-LUMEN CATHETER, A CHEST X-RAY WAS COMPLETED. A PIECE OF THE GUIDE WIRE HAD BROKEN OFF AND WAS NOW IN THE PT'S RIGHT VENTRICLE.
THE SIDE AND ONE AREA OF THE RIM ARE FOCALLY CHIPPED AND DISTORTED.
21 FR 36" TUBE WAS NEEDED FOR A CRITICALLY ILL PT IN AN INTENSIVE CARE UNIT. THE FIRST TWO TUBING SETS WERE TAKEN FROM THE STORAGE AREA AND IT WAS FOUND THAT THE LATEX BALLOONS HAD DETERIORATED IN THE PACKAGE. THE THIRD SET WAS USED ON THE PT. THE THIRD SET WAS IN GOOD CONDITION.
TISSUE EXPANDER WAS PLACED IN PT'S BREAST ON 9/28/95. THE EXPANDER DEFLATED AND WAS REMOVED FROM THE PT ON 11/2/95. CAUSE OF DEFLATION OF EXPANDER UNKNOWN. QUESTION PRODUCT PROBLEM OR OPERATOR PROBLEM.
FOUND RESIDENT LYING ON FLOOR WITH LEFT FOOT CAUGHT BETWEEN BED FRAME AND BEDRAIL. SHE HAD SKIN TEAR ON LEFT ELBOW APPROX 1 1/2" LONG. LEFT ELBOW AND ANKLE WERE SWELLING AND DISCOLORED. PT HAD SEVERE PAIN WHEN LEFT ANKLE TOUCHED. BEDRAIL WAS UP AT 6:30 AM, BUT WHEN RESIDENT WAS FOUND AT 7:00 AM, BEDRAIL WAS DOWN ON LEFT SIDE. RESIDENT WAS SENT TO HOSP.
RESIDENT FOUND AT 6:45 AM IN BED LYING SIDEWAYS WITH HEAD TURNED TO SIDE AND LODGED IN BEDRAIL. ATTEMPTED TO DISLODGE HEAD - UNSUCCESSFUL. TRIED TO GET RESIDENT TO PULL HEAD BACK OUT. HE COULDN'T. RESIDENT STATED "IT HURTS." SMALL AMOUNT OF BLOOD NOTED ON RIGHT EAR. 11-7 SUPERVISOR CALLED. SHE CAME AND AGAIN THEY ATTEMPTED TO DISLODGE HIS HEAD BY SOAPING UP SIDES OF HEAD - UNSUCCESSFUL. MAINTENANCE MAN CALLED AND ARRIVED BY 7:05 AM. AGAIN THEY ATTEMPTED TO DISLODGE HIS HEAD WITH NO SUCCESS. FINALLY THEY HAD TO CUT THE BOTTOM PART OF THE RAIL WITH A SAW TO FREE RESIDENT. RESIDENT SUSTAINED SMALL LESION ON RIGHT BOTTOM EARLOBE AND A SMALL BRUISE ON TOP OF ONE EARLOBE, AND SMALL LESION BOTTOM ONE EARLOBE.
DURING INSERTION OF A SECOND STENT IN THE CIRCUMFLEX ARTERY, THE SECOND STENT BECAME DIFFICULT TO ADVANCE AND WAS DEPLOYED IN THE LEFT MAIN ARTERY. IN THE ATTEMPT TO RETRIEVE THIS STENT, A 0.014 CORONARY GUIDE WIRE WAS LEFT IN A VERY SMALL MARGINAL VESSEL WITH A STRAND OF THE BRAIDING OF THE WIRE EXTENDING TO THE AREA OF THE RIGHT FEMORAL ARTERY. THE SHEATH WAS REMOVED SURGICALLY THE NEXT DAY AND THE WIRE WAS SECURED TO THE RIGHT FEMORAL ARTERIAL WALL.
SUBCUTANEOUS INFUSION SET (27G, 3/4", 30 DEGREE BEND NEEDLE) WAS BEING USED TO ADMINISTER PAIN MED PER CONTINUOUS INFUSION PUMP. NEEDLE WAS INSERTED IN CLIENT'S ABDOMEN. WHILE PERFORMING ROUTINE SITE CARE, RN NOTED NEEDLE HAD SNAPPED OFF AT HUB AND WAS LYING UNDERNEATH TRANSPARENT DRESSING.
SUBCUTANEOUS INFUSION SET (27G, 3/4", 30 DEGREE BEND NEEDLE) WAS BEING USED TO ADMINISTER PAIN MED PER CONTINUOUS INFUSION PUMP. NEEDLE WAS INSERTED IN CLIENT'S ABDOMEN. WHILE PERFORMING ROUTINE SITE CARE, RN DISCOVERED NEEDLE NO LONGER ATTACHED TO REST OF INFUSION SET. NEEDLE NOT RECOVERED.
PT'S EYE WAS BURNED DUE TO PHACO HANDPIECE. 1) CONNECTION NOT MADE PROPERLY WITHIN THE TIP OR 2) SOLUTION NOT FLOWING THROUGH HANDPIECE.
DURING THE INSERTION OF AN IMPLANTED PORT BY DR, THE DR COULD NOT REMOVE THE GUIDE WIRE FROM THE PT'S RIGHT SUBCLAVIAN VEIN. HE OBSERVED THE WIRE TO BE "STRIPPED" OR UNRAVELED AND COILED IN THE RIGHT SUBCLAVIAN VEIN. THIS WAS A GUIDE WIRE FROM THE IMPLANTED PORT. THORACIC-CARDIOVASCULAR SURGEON WAS CALLED IN AS A CONSULTANT. THE WIRE WAS LEFT IN THE RIGHT SUBCLAVIAN VEIN. IT WAS LOOPED AND SUTURED IN PLACE.
PT ARRIVED IN OR WITH PRE-OP MEDICAL DIAGNOSIS OF LEFT URETERAL OBSTRUCTION. PT WAS CYSTOSCOPED AND URETEROSCOPED. DR DISCOVERED A RETAINED SHEATH BELIEVED TO BE FROM A LASER STONE BASKET WHICH WAS USED PREVIOUSLY TO ATTEMPT RETRIEVAL OF A URETERAL STONE. THE SHEATH WAS SUCCESSFULLY RETRIEVED WITHOUT UNTOWARD EVENT.
AT APPROX 0550 HRS, 7/31/95, ALARMS INDICATING "CHECK IAB CATHETER" AND "RAPID GAS LOSS" WENT OFF. ATTEMPT TO FILL IAB WAS UNSUCCESSFUL; CONDENSATION AND BLOOD FLECKS NOTED IN IAB. BALLOON WAS PULLED OUT IN SURGERY AND IS IN THE RISK MGMT DEPT OF FACILITY.
PT IS A 23-YR-OLD MAN WHO UNDERWENT A SHUNT REVISION ON 11/13/92 USING A CSF PERITONEAL CATHETER. THE PT RECENTLY DEVELOPED SYMPTOMS OF SHUNT MALFUNCTION, AND SHUNT PATENCY STUDIES SHOWED NO FLOW OF TRACER BELOW THE MEDIUM PRESSURE VALVE. AT THE TIME OF SHUNT EXPLORATION, IT WAS FOUND THAT THE PERITONEAL CATHETER WAS DISCONTINUOUS BELOW THE VALVE, ALTHOUGH THE CONNECTION TO THE VALVE ITSELF WAS INTACT. THIS IS THE SECOND CASE RPTR HAD, THE OTHER ONE HAVING BEEN REVISED ON 3/2/93. RPTR IS CONCERNED AS THERE ARE TWO CASES NOW, APPROX TWO YEARS OLD IN WHICH THE CATHETER HAS BROKEN SPONTANEOUSLY, BY ALL APPEARANCES. (*)
FINGER PROSTHESIS (MCP) FRACTURED AT ONE YEAR POST-OP REQUIRING RE-IMPLANTATION. THERE WERE 4 PROSTHESES IMPLANTED ORIGINALLY AND 3 WERE FOUND TO BE DEFECTIVE. THE FOURTH WAS REPLACED BECAUSE OF SUSPICION OF FUTURE OCCURRENCES. THE FOLLOWING DETAIL DESCRIBES HOW EACH JOINT PROSTHESIS FAILED: INDEX FINGER ALMOST COMPLETELY BROKEN THROUGH AT THE DISTAL ARM AND WHERE THE PROXIMAL PHYALANX ABUTS THE PROSTHESIS. LONG FINGER BROKEN COMPLETELY AT THE DISTAL ARM. RING FINGER SAME AS THE INDEX FINGER. LITTLE FINGER NOT BROKEN; REMOVED/REPLACED BECAUSE OF UNCERTAINTY ASSOCIATED WITH IMPLANT INTEGRITY. THE REP HAS BEEN CONTACTED AND THE JOINTS WERE SUBMITTED TO THE CO (BY THE PHYSICIAN) FOR ANALYSIS. IN A PREVIOUS CASE, THERE WAS ALSO ONE INDEX FINGER PROSTHESIS THAT WAS IMPLANTED ON 2/24/94 AND WAS EXPLANTED ON 7/29/94. THIS WAS ALSO DUE TO PRODUCT FAILURE.
THE SURGEON EXPERIENCED DIFFICULTY IN PLACEMENT OF A 10MM DISPOSABLE TROCAR DURING AN ATTEMPTED LAPAROSCOPIC VAGINAL HYSTERECTOMY. INTRA ABDOMINAL VISUALIZATION REVEALED BLOOD IN THE PERITONEAL CAVITY. THE INNER SHEATH OF THE TROCAR WAS REMOVED AND NOTED BY THE SURGEON TO BE BENT AND DEFORMED. SUBSEQUENT OPEN LAPAROTOMY REVEALED LACERATED LEFT COMMON ILIAC VEIN. VEIN WAS REPAIRED.
THE PHYSICIAN WAS USING A 2.4FR EHL PROBE TO BREAK UP A URETERAL CALCULI. THE PHYSICIAN STATED THAT THE PROBE BROKE AND WENT THROUGH THE URETER. A GRASPER WAS USED TO RETRIEVE THE PORTION OF THE PROBE WHICH HAD BROKEN OFF. PT EXPERIENCED DROP IN BLOOD PRESSURE. POSSIBLE ABSORPTION OF NORMAL SALINE IRRIGATION. PT WAS STENTED POST-OP. THIRTY MINS WAS ADDED TO PROCEDURE.
INTRAARTERIAL CATHETER WAS TIED IN A KNOT IN PT'S ARTERY. ATTEMPTS WERE MADE UNSUCCESSFULLY TO UNTIE THE KNOT WHILE CATHETER WAS STILL INSIDE PT. WHEN THESE ATTEMPTS FAILED, PT WAS SENT TO SURGERY FOR ARTERIOTOMY AND CATHETER WAS REMOVED.
ACTUAL SIZE IMPRINTED ON TREPHINE WAS 7.5 MM, SIZE SHOWN ON CONTAINER WAS 8.5 MM. THIS WASN'T DISCOVERED UNTIL PHYSICIAN HAD CUT DONOR CORNEA AND THEN REALIZED THAT THE CORNEA IMPLANT WOULDN'T FIT. IMPLANT HAD TO BE REMOVED AND PT'S OWN CORNEA REINSERTED. UNDER A SEPARATE PROCEDURE, A SECOND DONOR CORNEA HAD TO BE CUT TO FIT THE 7.5 MM INCISION AND WAS IMPLANTED. PACKAGING OF TREPHINE IS IN TWO PARTS. OUTSIDE BOX DISPLAYS PRODUCT SIZE, INSIDE BUBBLE PACK DOESN'T DISPLAY SIZE. OUTSIDE BOX ISN'T SECURE IN ANY WAY TO PREVENT IT FROM BEING OPENED PRIOR TO USE.
AFTER INDUCTION, MONITOR NOTED TO READ ABNORMALLY LOW ETCO2 FOR ADEQUATE VENTILATION PATTERN 24MMHG. ALSO AGENT MONITOR READ ONE-HALF OF DELIVERED, 0.4% VS 1% READING. A NEW ETC02 MONITOR WAS BROUGHT INTO THE ROOM, THE SAME CATHETER WAS USED. ETC02 READ 48MMHG, VENTILATION PATTERN WAS READJUSTED TO NORMAL. NO INJURY TO PT NOTED OR EXPECTED.
FIRST STAPLER - HAND UNIT FELL APART DURING USE. SECOND STAPLER, STAPLE LINE FELL APART, STAPLES RETRIEVED AND LINE RECAUTERIZED.
PT DEVELOPED LEFT LEG NEUROPATHY RESULTING IN IMPAIRED MOBILITY FOLLOWING REMOVAL OF DEVICE AFTER PTCA.
BLOOD PRESSURE MONITOR INFLATED TO HIGHER LEVEL THAN FOR WHICH IT WAS PROGRAMMED. MAY HAVE CONTRIBUTED TO THROMBOSIS IN UPPER ARM OF PT SYMPTOMS QUICKLY RESOLVED WITH NO FURTHER DAMAGE. INCIDENT REPORTED TO MFR AND ALL IDENTICAL MONITORS RETURNED TO MFR FOR VALIDATION OF PROPER WORKING CONDITION. NO PROBLEMS REPORTED.
END OF INJECTOR DEVICE USED TO IMPLANT INTRAOCULAR LENS APPEARED JAGGED UPON INSPECTION AFTER LENS INSERTED.
WHILE REMOVING A POLYP DURING COLONOSCOPY WITH HOT BOIPSY FORCEP, THE METAL SHEATH OF THE FORCEP BROKE WITH THE JAWS OPEN. THE COLONOSCOPE HAD TO BE WITHDRAWN AND THE FORCEPS CUT WITH THE WIRE CUTTERS. THE PT WAS RESCOPED WITHOUT FURTHER INCIDENT.
INCOMPLETE CLOSURES OF BIOPSY FORCEP DURING COLONOSCOPY PROCEDURE. BIOPSY FORCEP AND SCOPE WERE REMOVED. PT WAS RESCOPED WITHOUT INCIDENT. NO APPARENT ADVERSE PT OUTCOME.
A 64-YR-OLD MALE PT WITH RESPIRATORY DISTRESS AND A HISTORY OF LUNG CANCER WAS ON THIS VENTILATOR FROM 7/3/95 - 7/6/95. ON 7/6/95 THE VENTILATOR ALARMED, SIGNALED "VENT INOPERATIVE" AND FAILED TO WORK. MANUAL VENTILATING WAS INITIATED BY THE STAFF. THE VENTILATOR'S FAILURE TO CONTINUE WORKING WAS DETERMINED NOT TO AFFECT THE PT'S STATUS. THIS EVENT WAS REPORTED TO THE MFR. THE EQUIPMENT WAS REPAIRED 7/11/95.
A FOLEY CATHETER WHICH HAD BEEN IN PLACE FOR A 39-YR-OLD MALE PT, FAILED TO DEFLATE COMPLETELY AT THE TIME IT WAS ORDERED TO BE DISCONTINUED. THE CATHETER WAS REMOVED WITH A RESULTING MODERATE AMOUNT OF PAIN. THE PT VOIDED WITHOUT PROBLEM FOLLOWING THE INCIDENT. IT WAS DETERMINED THAT THIS EVENT DID NOT ADVERSELY AFFECT THE PT'S CONDITION. THE EVENT AND DEVICE WERE PROMPLTY REPORTED TO THE MFR.
FIVE REPORTS OF IV TUBING SEPARATING AT FACTORY SEALED JUNCTION AT FIRST ADD SITE. (*)
THE INJECTION PORT OF THE CONTAINER CAME OFF PREVENTING THE INJECTION OF MEDICATION PRIOR TO INFUSION.
ON TWO SEPARATE OCCASIONS IV TUBING SEPARATED FROM IN-LINE PUMPING DEVICE. ON THE FIRST OCCASION THE PHYSICIAN WAS EXPOSED TO BLOOD PRODUCTS. ON THE SECOND OCCASION THE BLOOD HAD ALREADY BEEN INFUSED SO EXPOSURE WAS MINIMIZED.
DURING PATCH, HERNIA REPAIR PROCEDURE, DR PASSED SUTURE THROUGH THE PATCH AND THE SUTURE MATERIAL FRAYED AND BROKE. SUTURE REMOVED FROM PT. DEFECTIVE SUTURE MATERIAL RECEIVED IN DEPT OF BIOMEDICAL INSTRUMENTATION.
FACTORY SEALED SEAM ON ANESTHESIA CIRCUIT SEPARATED. PT HAD TEMPORARY DESATURATION. (*)
INSERTED 20 GAUGE 40 CM SINGLE LUMEN CATHETER WITHOUT DIFFICULTY. AFTER REMOVING THE GUIDE WIRE AND CONNECTING 5" EXTENSION, PT STATED SHE WAS HAVING TROUBLE BREATHING. THIS TROUBLE CONTINUED AND THE PT BECAME QUITE ANXIOUS. THE CATH WAS REMOVED. THE PT WAS PUT ON O2. AFTER A 5-10 MIN WAIT THE COMPLAINTS RESOLVED. THE PT ALSO C/O RETCHING AND HAD ABDOMINAL PAIN. AFTER RECEIVING INFO RELATED TO ADVERSE EVENTS WITH THE RELATED PRODUCT THESE WERE REMOVED FROM STOCK. THIS CATHETER IS THE SAME MATERIAL AND IS NOW BEING REMOVED FROM STOCK.
THE MALFUNCTION OF THE DEFIBRILLATOR OCCURRED ON 3/25/96 DURING A CODE. THE PT RECEIVED A SHOCK OF 200 JOULES WITH ANOTHER MFR'S DEFIBRILLATOR FIRST AND THERE WAS NO RESPONSE TO THIS SHOCK ON THE AGONAL RHYTHM. ALTHOUGH THE HOUSESTAFF AND THE PHYSICIANS SAW SPARKS, THE BODY DID NOT JUMP EXTENSIVELY AS THEY WERE USED TO AND THEREFORE AFTER TWO SHOCKS WITH ONE MACHINE (OTHER MFR'S) THEY ELECTED TO GO WITH THIS MACHINE. THE CODE WAS NOT SUCCESSFUL AND THE PT EXPIRED, BUT THE DEATH APPEARS TO BE UNRELATED TO THE POSSIBLE MALFUNCTION OF THE DEFIBRILLATORS. BOTH DEFIBRILLATORS WERE REMOVED FROM THE FLOOR AND RETURNED TO THE MFR.
THE MALFUNCTION OF THE DEFIBRILLATOR OCCURRED ON 3/25/96 DURING A CODE. IT APPEARED THE PT DID RECEIVE A SHOCK AND THE VOLTAGE WAS SET AT 200 JOULES. THERE WAS NO RESPONSE TO THIS SHOCK ON THE AGONAL RHYTHM. ALTHOUGH THE HOUSESTAFF AND THE PHYSICIANS SAW SPARKS, THE BODY DID NOT JUMP EXTENSIVELY AS THEY WERE USED TO AND THEREFORE AFTER TWO SHOCKS WITH ONE MACHINE THEY ELECTED TO GO WITH A SECOND MACHINE FROM A DIFFERENT MFR. THE CODE WAS NOT SUCCESSFUL AND THE PT EXPIRED, BUT THE DEATH APPEARS TO BE UNRELATED TO THE POSSIBLE MALFUNCTION OF THE DEFIBRILLATORS. BOTH DEFIBRILLATORS WERE REMOVED FROM THE FLOOR AND THE UNITS WERE RETURNED TO THE MFR.
TPN BAG CAPABLE OF HOLDING 2500/500 SPLIT AT SEAM. BAG ONLY HAD 1250/250 IN IT.
STAPLER WORKED FINE ON FIRST FIRING DURING PROCEDURE. WHEN UNIT WAS RELOADED FOR THE FIRST TIME, THE BLADE WOULD NOT SLIDE AT ALL AND STAPLES WOULD NOT FORM. DEVICE TO BE RETURNED.
STAPLER WOULD NOT FORM STAPLES, BLUE HAND PIECE JAMMED ON FIRST USE AND WOULD NOT GO FORWARD DURING EXPLORATORY LAPAROTOMY AND BOWEL RESECTION. DEVICE TO BE RETURNED.
NURSING SPECIALIST WAS SETTING UP UNIT FOR A CRANIOTOMY PROCEDURE PRIMING THE HANDPIECE, IT WAS NOTED THAT THERE WAS NO IRRIGATION COMING FROM THE TIP. ANOTHER HANDPIECE WAS OBTAINED, FLASH STERILIZED AND INSTALLED. IRRIGATION WAS OK ON PRIMING. DEFECTIVE TIP TO BE RETURNED.
LIP BURN AT JUNCTION OF PENCIL AND ELECTRODE WAS NOTED.
BRUISING ALONG LINE BETWEEN DUAL CUFFS WAS NOTED.
UNIT SELF ACTIVATED CAUSING DIME SIZE BURN.
15CM OF CATHETER REMAINED IN PT AND IDENTIFIED ON X-RAY. IT WAS SURGICALLY REMOVED.
A SPOT FILM OF C-7 WAS NEEDED. THE TABLE BUCKY WAS PLACED IN THE UPRIGHT 90 DEGREE POSITION. THE PT WAS THEN SEATED INBETWEEN THE TABLE AND THE X-RAY TUBE IN A LEFT LATERAL POSITION. THE TECH USED THE JOYSTICK FROM THE REMOTE OPERATED CONSOL TO MOVE THE TUBE DOWNWARD, THE ARM OF THE TUBE STRUCK THE PT'S LEFT KNEE. AS A RESULT THE PT'S HEEL HIT THE FLOOR CAUSING A FRACTURE.
PT WITH HISTORY OF OSTEOGENIC SARCOMA LEFT DISTAL FEMUR; 9/91 ENBLOC RESECTION, LEFT KNEE WITH INSERTION OF KNEE PROSTHESIS; 10/91 CLOSED MANIPULATION LEFT KNEE, 7/93 REMOVAL AND REPLACEMENT OF TOTAL KNEE PROSTHESIS. PT FELL ON LEFT SIDE 9/94 C/O KNEE PAIN. X-RAYS NEG (IN GREECE); 12/24/94 KNEE GAVE WAY WHILE WALKING ON FLAT SURFACE. PROSTHESIS FX ABOVE KNEE. ON 1/31/95 PT UNDERWENT REMOVAL AND REPLACEMENT OF BROKEN LEFT DISTAL FEMORAL PROSTHESIS. EVALUATION REVEALED FATIGUE FRACTURE PROCESS AT JUNCTION BETWEEN FEMORAL HINGE AND FEMORAL STEM.
PT IS S/P LEFT TOTAL ELBOW REPLACEMENT ON 6/27/91. ON 12/15/94 PT RETURNED TO HOSP FOR SPECIAL SURGERY AND X-RAYS WERE TAKEN REVEALING DISLOCATION OF THE AXLE COMPONENT OF THE TOTAL ELBOW DEVICE. THE HOSP WAS NOTIFIED OF THE PROBLEM ON 1/31/95. ON 2/9/95 THE PT UNDERWENT REVISION SURGERY. THE ULNAR COMPONENT WITH THE LOCKING CLIP STILL INSERTED AND THE HUMERAL COMPONENT LEFT IN PLACE. THE AXLE AND PLASTIC BEARINGS AND BUSHINGS WERE REPLACED.
PT ARRESTED ON TELEMETRY UNIT; EXTERNAL PACER/DEFIBRILLATOR PADS WERE PLACED ANTERIOR CHEST AND POSTERIOR. PT WAS TRANSFERRED TO CCU - REQUIRED EXTERNAL PACING AT 95 MAS X 6 HPS. PADS LEFT IN FOR 30 HRS UNTIL RHYTHM STABLE. WHEN REMOVED ANTERIOR PADS HAD 2 DIME TO QUARTER SIZED BLACK MARKS ON METAL SURFACE COVERED BY GEL. PT HAD 2 DIME TO QUARTER SIZED 3 DEGREE BURNS TO CHEST, SILVADENE APPLIED.
THE SURGICAL INSTRUMENT TECH WAS SETTING UP FOR A CASE WHEN THE LIGHT SOURCE COMPONENT ARCHED AS IT WAS TURNED ON. TECH CLAIMS ARCH TRAVELED THREE INCHES UP HER LEFT WRIST AREA, LEAVING A RED BURN MARK. SHORTLY AFTER, SHE EXPERIENCED TINGLING IN HER LEFT ARM AND RIGHT LEG. TECH WAS TREATED IN URGENT CARE AND ADMITTED FOR CHANGES IN HER EKG. EVIRONMENT CONDITIONS WITHIN THE MACHINES AREA WERE FOUND TO BE SAFE.
HEAT PACK WAS APPLIED DURING LABOR. PT HAD AN AREA OF BLISTERING FOLLOWING REMOVAL OF HEAT PACK. QUESTIONABLE CAUSE-FRICTION VS HEAT BURN.
HEAT PACK APPLIED TO SURGICAL AREA FOLLOWING MASTECTOMY. PT RECEIVED A THIRD DEGREE BURN WHICH LEFT A SCAR.
LIFT TIPPED DURING RESIDENT TRANSFER CAUSING RESIDENT SKIN TEAR AND BRUISE.
AFTER INSERTION OF TEMPORARY PACEMAKER EXTERNAL PACEMAKER WAS TURNED ON TO RATE OF 80 AND PT IMMEDIATELY WENT INTO VENTRICULAR TACHYCARDIA. MADE ADJUSTMENTS TO CONTROLS AND, AFTER 2ND ATTEMPT PT WENT BACK INTO VENTRICULAR TACHYCARDIA. EXTENAL PACERS WERE SUBSTITUTED AND NORMAL PACING WAS ACCOMPLISHED. NO HARMFUL EFFECTS TO PT WERE NOTED.
LOCK SYRINGES WITH PLASTIC LUER LOCK TIP STICK AT 5CC MARK SOMETIMES EVIDENT WITH SOME SYRINGES, THIS IS EVIDENT WHEN EMPTY, OTHER SYRINGES NOT EVIDENT. UNTIL SYRINGE IS FILLED AND AIR IS EXPELLED. WHEN THESE SYRINGES ARE USED WITH A SYRINGE PUMP, THE INFUSION WILL STOP AND ALARM AT THE 5CC MARK AND INFUSION CANNOT BE CONTINUED DUE TO PRESSURE IN SYRINGE.
PLASTIC SHARD SEEN IN DRIP CHAMBER OF IV TUBING. PARTICLE LIKELY SHEARED OFF THE INSDIE OF THE BURETTE INJECTION PORT.
RPTR WENT TO RADIOLOGY CTR FOR MAMMOGRAM. HER BREASTS ARE LARGE SO THEY USE A LOT OF COMPRESSION. THE PROBLEM IS THAT THE BREAST TISSUE CAN TAKE A LOT OF COMPRESSION BUT THE PECTORALIS MAJOR MUSCLES, UNDER THE ARMS CANNOT TAKE THAT MUCH COMPRESSION. THE PECTORALIS MAJOR MUSCLES WERE SPRAINED SO BAD THAT 4 YRS LATER SHE STILL HAS SPASMS WHICH DISABLED HER SO SHE CANNOT WORK AS A HAIR STYLIST OR ANYTHING. THIS PROCEDURE MUST BE CHANGED AND ANOTHER WAY TO X-RAY THE ARM PIT SHOULD BE FOUND. IN THE TECH'S REPORT, SHE LIES ABOUT WHY RPTR WAS CRYING. SHE SAYS RPTR WAS CRYING BECAUSE SHE THOUGHT SHE HAD CANCER OF RIGHT BREAST, RPTR TOLD HER SHE WAS CRYING BECAUSE IT HURT. (*)
RPTR HAD TITANIUM CAGES PLACED IN HER SPINE AT THE L5SI AREA. SHE HAD AN ANTERIOR/POSTERIOR FUSION WITH THIS SURGERY. SINCE THEN SHE HAS HAD ANOTHER SURGERY DUE TO PAIN IN HER LOWER BACK. SHE HAD A SPINAL COLUMN STIMULATOR PLACED IN HER TO HELP REDUCE THE PAIN. SHE CONTINUES TO HAVE A LOT OF PAIN WHERE THE CAGES ARE PLACED AND THIS AREA GETS VERY HOT TO THE TOUCH. SHE HAS BEEN SICK CONSTANTLY WITH SORE THROATS, SINUS PROBLEMS, AND JUST POOR HEALTH IN GENERAL. SHE CANNOT LIE ON HER RIGHT SIDE FOR MORE THAN 10 MIN AT A TIME, CANNOT STAND OR SIT FOR LONGER THAN 5 MINUTES, AND SLEEPING IS VERY HARD.
RPTR HAD AN ANTERIOR FUSION WITH INSTRUMENTATION, WASHERS AND TITANIUM CAGES BY MFR. EVER SINCE, HE HAS GONE FROM BEING DIZZY AND HAVING PERMANENT EAR INFECTIONS TO CONSTANT NIGHT SWEATS, LEG PAIN AND NUMBNESS, HERNIATION OF ABDOMINAL INCISION AND CONSTANT BACK AND HIP PAIN. HE IS PROBABLY ALLERGIC TO THE METAL, EVEN THOUGH TODAY THERE IS NO TEST FOR THIS METAL ALLERGIC REACTION.
IV NEEDLE DID NOT RETRACT. IT HAD TO BE TAPPED ON COUNTER TO RETRACT.
BECTON DICKINSON VASCULAR ACCESS, 9450 SOUTH STATE ST, SANDY, UT 84070. PT REP AT THE HOSP SAID THAT THE SAMPLES HAD NOT BEEN SAVED AND THE CAT AND LOT NUMBERS WERE NOT RECORDED. MS WELSH SAID THEY WOULD MAKE NOTE OF CAT AND LOT NUMBERS IN THE FUTURE SHOULD THEY EXPERIENCE ANY DIFFICULTIES WITH OUR PRODUCT.
DURING AN A-V GRAFT ANGIOPLASTY OF RIGHT LEG, THE TIP OF THE BALLOON CATHETER SEPARATED FROM THE CATHETER, LODGING IN THE GRAFT AND REQUIRING SURGICAL REMOVAL. FACTORY REP WAS CONTACTED. THE REP CAME AND REMOVED THE CATHETER FOR EVALUATION. AFTER THE TIP AND BALLOON SECTION WERE REMOVED FROM THE PT, THEY WERE SENT TO PATHOLOGY TO ASSURE ALL FOREIGN BODIES WERE REMOVED.
LIFT USED TO RAISE PT FROM WHEELCHAIR FOR TRANSFER TO BED. LIFT WOULD NOT LOWER, LEAVING PT SUSPENDED. CNA ASSISTED WITH HOLDING PT FOR APPROX 3 MINS WHILE LPN WORKED WITH CONTROLS, LIFT AND BATTERY UNTIL LIFT FINALLY LOWERED. RESIDENT LATER HOSPITALIZED WITH HEMATOMA RIGHT CHEST.
RPTR HAD BREAT IMPLANTS PLACED IN 1984. SHE HAD NUMBNESS IN THE SURGICAL AREA. SHE HAS HAD A TOTAL OF 3 BREAST SURGERIES. SHE HAD CALCIUM DEPOSITS AND 2 CAPSULAR CONTRACTURES. THE IMPLANTS RUPTURED. SHE C/O CARPAL TUNNEL SYNDROME, SHORT-TERM MEMORY LOSS, ELEVATED CHOLESTEROL OR TRIGLICERIDES, CHRONIC ARM PAIN, CHRONIC CONSTIPATION, AND SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS.
RPTR HAD BREAST IMPLANTS PLACED 5/18/87. SHE HAD NUMBNESS IN THE SURGICAL AREA AND BLEEDING THOUGH THE ENVELOPE. SHE C/O: PERIPHERAL NEUROPATHY, CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, MOOD SWINGS, PROCRASTINATION, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, CHEST/RIB CAGE PAIN &/OR BURNING SENSATION AND INFLAMMATION, ELEVATED CHOLESTEROL OR TRIGLYCERIDES, EYE MICRO-ANEURYSM, CHRONIC SWELLING AND  PAIN OF EXTREMITIES, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, FREQUENT MIGRAINES/SEVERE HEADACHES, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, CONNECTIVE TISSUE DISEASE, ELEVATED LIVER ENZYMES AND TOTAL BILIRUBIN, ASTHMA, VARIANT COUGH, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS, PAINFUL AND TENDER LYMPH NODES, CHRONIC UNEXPLAINED MUSCLE SPASMS, MUSCLE PAIN & BURNING, FIBROMYALGIA, FASCITIS, UNEXPLAINED RASHES, SUN SENSITIVITY, CHRONIC INSOMNIA, LONG-TERM EXRTREME FATIGUE. (*)
A 41-YR-OLD FEMALE HAD AN EXPLORATORY LAPAROTOMY AS A RESULT OF CHRONIC PELVIC PAIN WHICH HAD BEEN UNRESPONSIVE TO MEDICAL MANAGEMENT. DURING THE PROCEDURE, THE PT SUSTAINED AN AORTIC LACERATION AND INJURY TO THE SMALL BOWEL, CAUSED BY A TROCAR USED IN THE PROCEDURE. THERE WAS MASSIVE BLOOD LOSS. SURGICAL REPAIR WAS DONE. HER BLOOD PRESSUE COULD NOT BE MAINTAINED. SHE EXPIRED EIGHT HRS LATER.
RESIDENT WAS SEATED IN WHIRLPOOL CHAIR. THE CHAIR AND THE RESIDENT WERE BEING LIFTED OUT OF THE WHIRLPOOL WHEN THE SEAT BELT BROKE AND THE RESIDENT FELL TO THE FLOOR.
BEGINNING IN 10/94 AFTER APPROX 2 MOS OF GLOVE USE RPTR DEVELOPED SEVERE EXCEMA ON HER HANDS WHICH CONTINUED TO RECUR UNTIL 8/95 WHEN SHE SWITCHED TO VINYL GLOVES. THEN IN 11/95, SHE TRIED A PAIR OF LATEX GLOVES AFTER A CASE AND WITHIN 5 MINS SHE BROKE OUT WITH A GENERALIZED RASH, MILD RESPIRATORY DISTRESS, SNEEZING AND ITCHY EYES. THIS REACTION REQUIRED A CORTISONE INJECTION AT THE TIME OF THE EVENT, IN ADDITION TO THE MONTHLY INJECTIONS SHE HAS BEEN RECEIVING SINCE 8/95. SHE WAS FORCED TO QUIT WORKING SINCE 12/95, SECONDARY TO LATEX ALLERGIES.
RPTR HAD A SOLID SILICONE IMPLANT PLACED ABOVE HER EYES (ABOUT 50% OF HER LOWER FOREHEAD) WHEN SHE WAS 10 YEARS OLD, 20 YEARS AGO. SHE HAD SOME BREATHING PROBLEMS FOR ABOUT 5 YEARS; THEN, STARTING ABOUT 1/1/95, SHE BEGAN SUFFERING FROM EXTREME HEAD PAIN FOR EXTENDED PERIODS OF TIME. SHE LOST HER BALANCE AND WAS UNABLE TO DRIVE OR READ DUE TO PAIN. HER NOSE AND THROAT WOULD SWELL UNTIL THEY WERE ALMOST CLOSED. SHE WENT TO THE ER AND WAS SENT HOME WITH DROPS. EVENTUALLY SHE LOST HER BALANCE AND COULD BARELY WALK. SHE IS SCHEDULED TO GO BACK TO SURGERY IN ABOUT 2 WEEKS. CURRENTLY, THE HEAD PAIN AND SOME OF THE SWELLING HAVE SUBSIDED.
RPTR STATES THE LIFT IS BEING SOLD AND IT HAS NOT BEEN APPROVED BY THE FDA.
PT REPORTS THAT SYRINGES WERE FOUND WITH NEEDLES UNCAPPED INSIDE NONSTERILE PACKAGES. ONE NEEDLE HAD A LARGE "BURR" AT THE TIP. SYRINGE BARRELS WERE SOMETIMES NOT STRAIGHT. PLUNGER TIPS SOMETIMES DID NOT SEAL AGAINST INNER SURFACE OF BARREL SO THAT AIR LEAKED IN OR INSULIN LEAKED OUT. OCCURRED PRIOR TO DISCOVERING PROBLEM. (*)
THE ZIP CLOSURE PART OF THE BAG IS NOT SEALED PROPERLY TO THE BAG. USUALLY THE DEFECT IS NOTICED PRIOR TO THE BAG BEING USED. ON ONE OCCASION, A CHOMO SPILL OCCURRED BECAUSE THE SPIKE PIERCED A BAG CONTAINING A CHEMOTHERAPY AGENT AND THE DEFECTIVE CHEMO BAG WAS NOT ABLE TO CONTAIN THE FLUID.
DATE OF OCCURRENCE 8/17/95. DURING A SURGICAL LAPAROSCOPY, THE SURGEON WAS USING THE SUCTION IRRIGATOR TO SUCTION SOME BLOOD OUT OF THE ABDOMEN. WHILE USING THIS DEVICE, A PORTION OF THE BOWEL AND FAT ATTACHED TO THE BOWEL WAS SUCKED UP INTO THE DISTAL END OF THE SUCTION TIP. THE SURGEON ATTEMPTED TO RELEASE THE BOWEL BY IRRIGATING THROUGH THE DEVICE AND BY THE COMPLETE RELEASE OF SUCTION, BUT WAS UNSUCCESSFUL. THE SUCTION WAS OPERATING AT THE REGULAR FLOW RATE. A LAPAROTOMY WAS PERFORMED TO CORRECT THE PROBLEM. THE PT'S BOWEL APPEARED BRUISED INITIALLY. FOLLOW-UP CONTACT WITH THE SURGEON REGARDING THE PT REVEALED THAT THE PT WAS DOING WELL. (*)
THE FILTER SECTION OF THE MACHINE WILL NOT STAY IN CLOSED POSITION TO PROMOTE A VACUUM SUCTION. UNIT REMOVED FROM USE UNTIL DETERMINATION BY MFR IS MADE.
LPN WHILE MAKING ROUNDS FOUND RESIDENT SUSPENDED FROM RIGHT SIDE OF BED WITH RESTRAINT AROUND HER BREAST PLATE.  RESIDENT HAD NO PULSE OR RESPIRATION.
LEFT BREAST IMPLANT REMOVED DUE TO POSSIBLE LEAKING IMPLANT - RETURNED TO MFR. IMPLANT WAS STERILIZED ACCORDING TO MFR'S INSTRUCTIONS - RUPTURED DURING STERILIZATION. PT NOTED CHANGE IN VOLUME AS COMPARED TO OTHER SIDE.
VENTILATOR MADE A HISSING NOISE, THEN POPPED (A POPPING NOISE) - THEN QUIT WORKING. INVESTIGATION BY BIOMED STAFF REVEALED BURST TUBING INSIDE THE COMPRESSOR (NOT THE VENTILATOR).
DILATOR AND INTRODUCER WERE BEING PLACED OVER GUIDE WIRE. UPON REMOVAL OF DILATOR AND GUIDE WIRE, GUIDE WIRE CAME OUT UNRAVELED, WITH INNER WIRE INTACT. DR THOUGHT ENTIRE GUIDE WIRE REMOVED. X-RAY DONE. SHOWED 4 INCHES OF WIRE STILL IN RIGHT BRACHIAL CEPHALIC VEIN. WIRE WAS REMOVED IN INTERVENTIONAL RADIOLOGY THROUGH FEMORAL APPROACH. PT IS OK.
PT ADMITTED TO HOSP ON 3/6/96. HOSP CHOSE TO USE PT'S VENTIALTOR DURING THE COURSE OF HIS HOSP STAY. PT WAS LAST CHECKED BY HOSP STAFF AT 11:10 PM. AT 11:40 PM A LAB TECH DISCOVERED PT DISCONNECTED FROM VENTILATOR AT THE TRACH WITH THE VENTILATOR CIRCUIT RESTING ON THE PT'S CHEST. NURSE WAS SUMMONED, PT HAD NO HEART TONES, NO RESPIRATIONS. PER STAFF AT HOSP THEY THEN OBSERVED THE VENTILATOR CONTINUING TO CYCLE AND NO ALARMS WERE SOUNDING TO ALERT TO THE DISCONNECTION. PT HAS BEEN ON THIS VENTILATOR SINCE 2/16/96. LAST HOME VENTILATOR CHECK 2/16/96. LAST PM 5/95.
SEVENTY-YEAR-OLD FEMALE ADMITTED FOR INSERTION OF PACEMAKER DUE TO COMPLAINTS OF DIZZINESS AND FAINTING SPELLS. AT CLOSE OF PROCEDURE (WHILE STILL IN OR) PT COMPLAINED OF CHEST DISCOMFORT. PT LOST CONSCIOUSNESS, UNABLE TO OBTAIN PULSE. CODE CALLED, UNABLE TO RESUSCITATE. PT EXPIRED. AUTOPSY PERFORMED, RESULTS NOT AVAILABLE AS OF 3/27/96.
PT WAS BEING TREATED FOR OBSTRUCTIVE SLEEP APNEA WITH A CPAP MACHINE. THE DEVICE INCREASED PT SAO2 TO THE LOW 90'S WHEN IN USE. PT WAS FOUND TO BE WITHOUT HEART BEAT OR RESPIRATIONS WHILE ON THE CPAP MACHINE, HOWEVER, HE WAS RESUSCITATED AND TRANSFERRED TO THE COMMUNITY HOSP.
STENT WAS PLACED IN SVC OVER WIRE ALREADY IN PLACE. SHEATH WAS RETRACTED. NEGATIVE PRESSURE PULLED ON BALLOON. AFTER INJECTION OF DYE TO VISUALIZE, BALLOON INFLATED. BALLOON WOULD NOT HOLD DYE AND STENT WOULD NOT DEPLOY. AFTER SEVERAL ATTEMPTS THE BALLOON WAS TOTALLY DEFLATED AND SYSTEM REMOVED, EVERYTHING BUT WIRE AND SHEATH. THE GUIDE CATHETER WAS ALSO REMOVED ALONG WITH STENT SYSTEM. STENT WAS NOT ON BALLOON. THERE WERE 3 PIN HOLES IN DISTAL END OF BALLOON. BALLOON ASSEMBLY WAS HANDED OFF TO THE CIRCULATOR. STENT REMAINED IN PT. PT PLACED ON IABP. EXPIRED ABOUT 48 HRS POST PROCEDURE.
THE PT WAS BROUGHT TO THE OR FOR REPAIR OF RIGHT HIP FRACTURE. THE PLAN WAS TO IMPLANT A RIGHT HIP BIPOLAR ENDOPROSTHESIS. PT WAS GIVEN ANESTHESIA. HER BP WAS STABLE. SHE WAS PLACED ON THE OR TABLE. THE CEMENT WAS INSERTED AT 1330. THE PROSTHESIS WAS THEN INSERTED. AT 1337 HER HEART RHYTHM BECAME IRREGULAR WITH SLOWING; BP STARTED TO DROP AND THE PT STOPPED BREATHING. STEPS WERE TAKEN TO RESTORE BP. SHE WAS INTUBATED AND CHEST COMPRESSION WAS BEGUN. THROUGHOUT THIS PERIOD OF TIME 1337 TO 1404 PT HAD PULSELESS ELECTRICAL ACTIVITY. AT 1404 SHE HAD VENTRICULAR FIBRILLATION. SHE WAS DEFIBRILLATED. AT THIS TIME HER EKG BECAME FLAT LINE. CPR WAS TERMINATED.
CATH LAB INSERTED BALLOON, THEN TRANSFERRED PT TO ICU. PT WAS UNSTABLE, POOR DISTAL PERFUSION, WITH OCCASIONAL ALARMING OF IABP. SYSTOLIC PRESSURE > 80 MM HG WITH DOPAMINE BEING TITRATED. PT'S SYSTOLIC PRESSURE CONTINUED TO FALL (60 - 70 MM HG OVER NEXT TWO HRS). AUGMENTATION DIMINISHED AND IABP BEGAN ALARMING CONTINUOUSLY. IAB TUBING GAINED CLOUDY APEARANCE - THEN CHANGED TO BLOOD. THE PT THEN CODED, CPR WAS INITIATED, HOWEVER, THE PT EXPIRED.
IMPLANT LOSS, THREE YEARS AFTER PLACEMENT, ACCOMPANIED BY PROGRESSIVE RADIOGRAPHIC BONE LOSS.
PLASTIC WORE ON BOTH TIBIAL INSERT AND PATELLA REMOVED AND REPLACED BOTH.
PT HAD MASTECTOMY OF RIGHT BREAST W/RECONSTRUCTION W/SILICONE IMPLANT IN 1985. IMPLANT HAD SHIFTED AND CHANGED SHAPE. IMPLANT FOUND TO BE RUPTURED. REPLACED W/SALINE AND TRAM FLAP RECONSTRUCTION.
PT HAD PREVIOUSLY UNDERGONE SUBMAMMARY IMPLANTATION BILATERALLY OF SILICONE IMPLANTS IN 1974; RUPTURE ON BOTH SIDES. REPLACEMENT BILATERAL W/SALINE.
PT HAD SILICONE IMPLANTS PLACED 17 YEARS AGO WITH REPLACEMENT W/SALINE APPROX. ONE YEAR AGO; LEFT IMPLANT HAS DEFLATED. REPLACED WITH NEW IMPLANT.
PT W/BREAST CA AND LEFT MASTECTOMY 3 YRS. AGO; TISSUE EXPANDER WAS PLACED. OVER THE LAST THREE MONTHS, EXPANDER HAS DECREASED IN SIZE. FOUND TO BE RUPTURED OR BROKEN DURING PROCEDURE.
PT W/HISTORY OF SILICONE IMPLANTS PLACED 17 YRS. AGO WITH REPLACEMENT OF SALINE APPROX ONE YEAR AGO. LEFT IMPLANT DEFLATED AND WAS REPLACED ON 1/19/96. LEFT IMPLANT HAS AGAIN RUPTURED/DEFLATED; REPLACEMENT PROCEDURE.
DURING KNEE ARTHROSCOPY, THE SURGEON WAS ATTEMPTING TO GRASP A LOOSE BODY INSIDE THE KNEE AND THE TIP OF THE GRASPER BROKE OFF. THE BROKEN PIECE WAS RETRIEVED AND THE SURGERY PROCEEDED WITHOUT FURTHER INTERRUPTION.
FOREIGN MATERIAL ATTACHED TO STYLET AT THE HUB/BASE AREA. ANESTHESIOLOGIST NOTED IT AFTER PLACING NEEDLE INTO PT.
KNEE ARTHROSCOPY ON 4/29/96. FOLLOWING DAY A ROUTINE KNEE X-RAY SHOWED A FOREIGN BODY IN KNEE. PT RETURNED TO OR ON 5/2/96 AND FOREIGN BODY WAS REMOVED. SURGEON FELT FOREIGN BODY WAS PART OF CAUTERY FROM DEVICE USED ON MONDAY'S PROCEDURE.
TRANSPORT VENTILATOR ALARMED AND FAILED TO FUNCTION ON PT. PT WAS HAND VENTILATED WITHOUT INJURY OR HARM.
VENTILATOR WENT "VENT INOP" (FAILED) ON PT. THERAPIST HAND VENTILATED PT. NO HARM WAS CAUSED TO PT. THE MFR WAS NOTIFIED. THE VENTILATOR IS BEING REPAIRED/TESTED.
NURSERY STAFF REPORTED THAT THERE WAS NO AUDIBLE ALARM OR RECORDING OF ALARMS ON THIS PT. PT WAS FOUND IN ASYSTOLE. SYSTEM WAS CHECKED BY CO AND SITUATION COULD NOT BE DUPLICATED, HOWEVER THERE WAS A "YELLOW LEVEL" ALARM TONE THAT DID NOT RESPOND FOR 4 SECONDS, WHICH WAS A DELAY.
NURSERY STIFF REPORTED THAT THERE WAS NO AUDIBLE ALARMS OR RECORDING OF ALARMS ON THIS PT. PT WERE FOUND IN ASYSTOLE. SYSTEM WAS CHECKED BY CO AND SITUATION COULD NOT BE DUPLICATED, HOWEVER THERE WAS A "YELLOW LEVEL" ALARM TONE THAT DID NOT RESPOND FOR 4 SECONDS, WHICH WAS A DELAY.
PT IS VERY CONCERNED ABOUT HER LOSS. THIS BRUSH SYSTEM HAS A THICK WIRE AND LOOP AT TIP END TO HOLD THE BRISTLES. THE THICK LOOP AT THE TIP IN THIS PT WITH TIGHT INTERDENTAL SPACE HAS CAUSED HER DISCOMFORT. THE PRESSURE ON TISSUE & ESPECIALLY BONE WILL CAUSE IRREPARABLE BONE LOSS.
PT HAD AICD IMPLANTED 9/29/95. PT EXPERIENCED VENTRICULAR FIBRILLATION ON DATE OF EVENT. AICD DID NOT CORRECT FIBRILLATION. PT HAD CPR AND RETURNED TO SURGERY FOR CHANGE OF LEAD.
REDO OF TOTAL KNEE REPLACEMENT, MEDIAL TIBIAL TRAY, LOSSENING OF TIBIAL COMPONENT, UNDERMINING OF PATELLAR COMPONENT. TOTAL KNEE RE DO 4/30/96.
DURING THE REMOVAL OF AN ACOUSTIC NEUROMA, THE DEVICE WAS BEING USED AS A MONITOR. THE SURGEON SEVERED THE FACIAL NERVE. IT WAS REPORTED THAT THE DEVICE DID NOT PROVIDE A RESPONSE AT THE TIME THE NERVE WAS SEVERED.
PT BEGAN COUGHING UP COPIOUS AMOUNTS OF FRANK BLOOD VIA ENDOTRACHEAL TUBE, ALSO BECAME HEMODYNAMICALLY UNSTABLE. TWO RESPIRATORY THERAPISTS PRESENT TO SUCTION AND MAINTAIN AIRWAY. BLOOD HAD BACKED UP INTO THE VENT TUBING AND FILTER. THE ETT NEEDED TO BE SHORTENED, AND IN SO DOING THE IN-LINE SUCTION CATH WAS APPARENTLY NOT RETRACTED TOTALLY AND A 3" SEGMENT WAS CUT AND ASPIRATED BY PT INTO RIGHT MAINSTREAM BRONCHUS. VISUALIZATION OF IN-LINE SUCTION CATH OCCLUDED IN ETT SECONDARY TO THE COPIUS BLEEDING. REMOVED VIA BRONCHOSCOPY.
DURING ROUTINE BRACHIAL ANGIOPLASTY, THE PTA BALLOON SEPARATED FROM THIS CATHETER. SURGICAL INTERVENTION SUCCESSFULLY REMOVED MOST OF THE BALLOON FROM THE PT. SOME MATERIAL WAS NOT RECOVERED. THE PORTION OF THE ITEM THAT WAS RECOVERED LOOKED AS IF THE BALLOON HAD BEEN CONSTRUCTED OF TWO PARTS. THE SEPARATION APPEARED TO HAPPEN IN A TRANSVERSE LINE, AS IF THE BALLOON HAD BEEN GLUED TOGETHER FROM TWO SEPARATE HALVES. THE PT WAS POST OPERATIVELY MONITORED FOR OUTCOMES, AND SUBSEQUENTLY DISCHARGED ON 2/19/96 WITH NO CONTRAINDICATIONS.
UPON INSERTION OF BLADE INTO EYE (UNDER MICROSCOPE) FRAGMENTS (METAL OR FINISH OF BLADE) WERE SEEN COMING OFF BLADE.
PT COMPLAINED OF LAXITY AND A PAINFUL KNEE WHEN WALKING OR CLIMBING AND DESCENDING STAIRS. KNEE WAS OPENED AND PATELLA WAS FOUND TO BE WORN TO THE METAL. TIBIAL INSERT WAS STILL INTACT BUT WAS DISCOLORED ON THE BEARING SURFACES BELOW THE MEDIAL AND LATERAL CONDYLES. THE PATELLA AND TIBIAL INSERT WERE BOTH REMOVED AN REPLACED.
PT HAD PORT IMPLANTED. WHEN ATTEMPTING TO INFUSE PORT, A LEAK WAS DETECTED IN CATHETER TUBING AT THE POINT WHERE IT (CATHETER) PASSES BETWEEN THE CLAVICLE AND THE 1ST RIB.
BECAUSE OF TUMOR THE ROD DIAMETER HAD TO BE ENLARGED. THE 15MM ROD AND SCREWS WERE REMOVED AND REPLACED WITH A 16X400MM FEMORAL ROD, CAP SCREW AND 2 EACH 5X50MM TRANSVERSE SCREWS.
POOR WEAR/DELAMINATION OF POLY COMPONENTS. PATELLA AND INSERT WERE REMOVED AND REPLACED.
PT EXPERIENCING PAIN. TIBIAL POLYETHYLENE FAILED OVER THE PAST THREE YEARS. PT REPORTED NO TRAUMATIC EVENT WHICH WOULD HAVE CAUSED THIS VERY EARLY FAILURE.
ACUTE EVENT WITH RESPIRATORY ARREST, HYPERTENSION AND NO LOSS OF HEART RATE. SERIAL HEAD CT SCANS REVEALED ACUTE HYDROCEPHALUS WHICH RESOLVED SOMEWHAT AFTER MANIPULATION OF SHUNT. CLAMP ON AIR VENT AT TOP OF BURETTE WAS FOUND TO BE CLOSED. DRAINAGE INCREASED WHEN CLAMP WAS OPENED. MENTAL STATUS CONTINUED TO DETERIORATE. PT WAS EVENTUALLY DECLARED BRAIN-DEAD.
DURING ROTATIONAL CORONARY ATHERECTOMY, PT BECAME HYPOTENSIVE WITH HEART BLOCK. ADVANCED CARDIAC LIFE SUPPORT WAS INITIATED WITHOUT SUCCESS.
A PT WITH A CHOLANGIOCARCINOMA DIAGNOSED 12/94 HAD CHRONIC PROBLEMS OF BILIARY TRACT STENOSIS SECONDARY TO TUMOR AND FIBROSIS. SHE HAD A SERIES OF PERCUTANEOUS BILIARY DRAINAGE TUBES WHICH REQUIRED PERIODIC REPLACEMENT. ON 1/11/96, A PERMANENT METAL STENT, 10 MM BY 42 MM, WAS PLACED FROM THE RIGHT HEPATIC DUCT TO THE COMMON BILE DUCT. THE PT RETURNED TO THE HOSP ON 1/19/96 WITH NAUSEA AND VOMITING, AND DEVELOPED HEMATEMESIS WITH DARK BROWN DIARRHEA. A RED BLOOD CELL SCAN FAILED TO SHOW A BLEEDING SOURCE. ANGIOGRAM ON 1/20/96 SHOWED A LARGE, FRIABLE TUMOR AND OBSTRUCTED HEPATIC ARTERY WITH NO OBVIOUS SOURCE OF BLEEDING. PHYSICIANS WERE THUS NOT ABLE TO OCCLUDE BLEEDING. EGD ON 1/21/96 SHOWED A CLOT IN THE STOMACH AND PARTIAL OBSTRUCTION AT THE SECOND PART OF THE DUODENUM. THE PT EXPIRED ON 1/26/96. AUTOPSY STATED THAT THE PT DIED FROM CHOLANGIOCARCINOMA IN THE PORTA HEPATIS REGION COMPLICATED BY GASTROINTESTINAL HEMORRHAGE. THE STENT PLACED 1/11/96 HAD ERODED INTO THE SURROUNDING TISSUE, SOME OF WHICH CONTAINED EXTENSIVE NECROSIS AND SCATTERED TUMOR GLANDS. THE EROSION EXTENDED INTO THE DUODENUM AND THE GASTRODUODENAL ARTERY CAUSING HEMORRHAGE.
MODIFIED MCBRIDE PROCEDURE ON RIGHT FOOT, BUNIONECTOMY/OSTEOTOMY. CELLULITIS DEVELOPED POST-OP WHICH DID NOT RESPOND TO MEDICAL TREATMENT. RETURN TO OR 3/13/96 FOR BONE BIOPSY WHICH SHOWED OSTEOMYELITIS OF THE DORSUM OF THE RIGHT FOOT. PT CONTINUES TO HAVE INCREASING OSTEOMYELITIS OF THE RIGHT FOOT AND ANKLE. SURGEON BELIEVES IMPLANT WAS NOT STERILE.
PT ADMITTED WITH SYMPTOMATIC BRADYCARDIA WITH KNOWN PERM PACEMAKER. INSERTED IN 1992 WITH REPLACEMENT IN 1993. PACEMAKER REPROGRAMMED TO CONFIRM NO OUTPUT. DR DECISION TO REPLACE. THRESHOLD CHECKS CONFIRM LEAD MALFUNCTION. COMPLETE SYSTEM REPLACED. DR DISCOVERED DURING PROCEDURE THAT ORIGINAL LEAD WIRE WAS NOT IN CONTACT WITH HEART WALL. ORIGINAL LEAD COULD NOT BE REPOSITIONED AND WAS REMOVED. NEW SYSTEM IMPLANTED. DOB 8/5/1897.
ON 12/11/92, PT PRESENTED WITH INTRACTABLE PELVIC PAIN AND ENDOMETRIOSIS. SHE HAD AN EXPLORATORY LAPAROTOMY, TOTAL ABDOMINAL HYSTERECTOMY, AND BILATERAL SALPINGO OOPHORECTOMY AND APPENDECTOMY. THIS WAS CLOSED WITH A RUNNING 4-0 VICRYL SUTURE, AND THE SKIN WAS RE-APPROXIMATED WITH STAPLES AND STRIPS. ON 11/9/93, SHE HAD AN EXCISION AND RE-SUTURE OF AN ABDOMINAL WOUND. DR EXCISED HER WOUND AND CLOSED THIS WITH SUTURE ON THE RECTUS FASCIA. THE SUPERFICIAL FASCIA WAS CLOSED WITH INTERRUPTED PLAIN GUT, AND THE SKIN WAS CLOSED WITH INTERRUPTED NYLON SUTURES. ON 5/19/94, DR PERFORMED AN OPEN LAPAROSCOPY FOR LYSIS OF ADHESIONS AND FULGURATION OF ENDOMETRIOSIS. HE FOUND DENSE BOWEL ADHESIONS TO THE ANTERIOR PERITONEAL SURFACE RUNNING ALONG HER PRIOR VERTICAL INCISION. THIS ONE QUESTION OF A SPOT OF ENDOMETRIOSIS ON THE ANTERIOR PERITONEAL SURFACE. ON 8/17/94, SHE PRESENTED TO DR FOR EXCISION OF A GRANULOMA OF THE LEFT UPPER EXTREMITY FOLLOWING PLACEMENT OF A TEST PIECE OF VICRYL. IT WAS CLOSED WITH 5 NYLON SUTURES. ON 10/19/94, SHE HAD EXCISION AND SUTURING OF HER ABDOMINAL WALL BY DR. SHE HAD A BACTERIOLOGY RESULT FROM 3/2/95 FROM HER ABDOMINAL WOUND WHICH GREW OUT ABUNDANT STAPH AUREUS WITH THE USUAL SENSITIVITIES. THE PATHOLOGY REPORT FROM 8/4/93 SHOWED SKIN AND SOFT TISSUE OF HER ABDOMEN WITH DERMAL FIBROSIS WITH FOREIGN BODY GIANT CELL REACTION TO FOREIGN MATERIAL CONSISTENT WITH SUTURE GRANULOMA. THE OPERATION ON 11/9/93, THE PATHOLOGY SHOWED SCAR TISSUE. THE OPERATION ON 2/25/94 SHOWED MILD PERIVASCULAR LYMPHOCYTIC INFILTRATION WITH SCATTERED NEUTROPHILS ON HER ARM. THE SUTURE GRANULOMAS FOUND ON 8/17/94. ON 10/19/94, THERE WAS POLARIZABLE BODIES AND BACTERIAL COLONIES AND FRAGMENTS CONSISTENT WITH SUTURE. ON EXAM, SHE HAS A LOWER MIDLINE SCAR WHICH IS A BIT HYPERTROPHIC WITH SEVERAL SMALL ULCERATIONS. THERE IS NO GROSS EVIDENCE OF INFECTION. AS OF 1/9/96, PT'S SMALL OPEN AREAS ALONG THE MIDLINE INCISION. SHE MENTIONED THAT THERE WAS A THREAD WHICH SHE PULLED OUT OF ONE OF THESE SOME TIME AGO. SHE IS UPSET ABOUT THE FACT THAT THIS MAY BE A REACTION TO VICRYL SUTURE USE SOME TIME AGO AND WOULD LIKE TO GET TO THE BOTTOM OF THIS.
TOWARDS END OF BYPASS FOR LUNG SURGERY, BLOOD FLOW DECREASED, PUMP RPMS INCREASED, AND ARTERIAL LINE PRESSURE REMAINED NORMAL. FLOW DECREASED FURTHER AND PUMP CONSOLE WAS CHANGED BUT FLOW DID NOT IMPROVE. TEN MINS BEFORE ENDING BYPASS, ARTERIAL AND VENOUS BLOOD GASES INDICATED OXYGENATOR WAS BEGINNING TO FAIL. SURGEON FINISHED FIRST LUNG AND ELECTED TO COME OFF BYPASS. OXYGENATOR WAS CHANGED, BUT PT WAS STABLE AND DID NOT REQUIRE REINSTITUTION OF CPB. PT DIED LATER THAT EVENING DUE TO MASSIVE COMPLICATIONS.
AFTER BYPASS WAS INITIATED, PT VASCULAR RESISTANCE AND MEAN ARTERIAL PRESSURE WERE LOW. NEOSYNEPHRINE WAS GIVEN. AMOUNT OF BLOOD IN THE RESERVOIR BAG WAS LOW DUE TO A CREASE IN THE MIDDLE OF BAG. VOLUME SEEMED TO BE "HANGING UP" IN THE TOP PORTION OF THE BAG. VOLUME WAS ADDED TO CIRCUIT TO INCREASE FLOWS. PT'S HB/HCT WAS LOW AND BLOOD WAS ADDED TO CIRCUIT PER ANESTHESIOLOGIST'S ORDER. CREASE IN BAG SUBSEQUENTLY DISAPPEARED. BYPASS WAS CONCLUDED SUCCESSFULLY; PT DID FINE POST-OP.
X-RAY SHOWED MEDIAL WEAR OF INSERT AND APPARENTLY WELL-FIXED COMPONENTS. SURGERY REVEALED WORN INSERT AND PATELLA. BOTH WERE REPLACED AND CLOSURE WAS ROUTINE.
NOISE ON THE STORED ELECTROGRAMS INDICATIVE OF A LEAD FRACTURE IN THE SENSE PACE LEAD. THE LEAD WAS CAPPED.
PT HAVING VOIDING CYSTOURETHROGRAM DONE. THE REPORTED CATHETER WAS TAPED AT THE SHAFT TO THE PT'S LEG. THE CATHETER PULLED APART AT THE Y-CONNECTOR AND SHAFT JOINT AS NOTICED BY URINE LEAKING FROM THE PT. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER CATHETER. NO FURTHER PT INJURY RESULTED. THE REPORTED DEVICE IS NOT AVAILABLE FOR EVALUATION; HOWEVER, PRODUCT FROM THE SAME LOT NUMBER WIL BE RETURNED FOR EVALUATION.
PT ROLLED OVER IN BED AND WAS AWAKENED BY A LOUD "POP." X-RAY SHOWED THAT CERAMIC HEAD HAD FRACTURED. DURING REVISION FEMORAL STEM REMOVED AND REPLACED.
IMPLANT LOST FOLLOWING PARTIAL PLACEMENT INTO MAXILLARY SINUS, ATTENDING CHRONIC SINUS INFECTION, PERI-IMPLANT BONE LOSS, ATTEMPTED BONE GRAFTING PROCEDURE, AND EVENTUAL LOSS OF IMPLANT.
IMPLANT REMOVED 3 YEARS AFTER PLACEMENT FOLLOWING PROGRESSIVE RADIOGRAPHIC BONE LOSS, ULTIMATELY ACCOMPANIED BY PAIN.
UPON CLOSING INSTRUMENT THERE WERE NO PROBLEMS. UPON FIRING IT OPENED; LOWER PART BROKE UPON REMOVAL AND UPPER BLADE FELL OFF INSIDE PT'S ABDOMEN. THIS WAS USING THE PRE-LOADED STAPLES (NO ADD'L STAPLES HAD BEEN ADDED). THE PT REQUIRED A LAPAROTOMY TO REMOVE THE PIECES AND STAPLES.
A BONE BIOPSY WAS BEING PERFORMED USING THE COAXIAL NEEDLE. THE GUIDE NEEDLE WAS REMOVED AND A 22 GAUGE WESTCOTT NEEDLE WAS INTRODUCED THRU THE SHEATH TO OBTAIN THE SPECIMEN. THE NEEDLE WAS REMOVED. THEN AN ATTEMPT WAS MADE TO REMOVE THE SHEATH BUT IT SNAPPED APART. THE SHEATH COULD NOT BE REMOVED BY FORCEPS SO THE PT WAS TAKEN TO SURGERY FOR REMOVAL.
DURING THE TIME FRAME OF AUG TO OCT 95, FACILITY HAS EXPERIENCED PROBLEMS WITH THE CONTROLS FOR THE PREGNANCY TEST KIT. DISCREPANCIES HAVE BEEN IN SERUM AS WELL AS URINE CONTROLS; SOMETIMES THE RESULT IS SO FAINT THAT IT IS VERY DIFFICULT TO INTERPRET AND OTHER TIMES THE EXPECTED POSITIVE CONTROL RESULT IS NEGATIVE. MFR PICKED UP 52 BOXES ON HAND AND WILL REPLACE WITH DIFFERENT LOT NUMBERS.
PACK CONTAINS A BIOLOGICAL INDICATOR WHICH DETERMINES WHETHER AN ITEM IS STERILE OR NOT. IF THE BIOLOGICAL INDICATOR IS ACTIVATED WITHOUT GOING THROUGH THE STERILIZATION PROCESS IT IS CALLED A CONTROL AND SHOULD SHOW A POSITIVE GROWTH READING WITHIN 24 HRS. THE CONTROLS WITH THIS ITEM HAVE NOT BEEN INDICATING A POSITIVE GROWTH WITHIN THE ALLOTTED TIME FRAME. SOME OF THE CONTROLS HAVE SHOWN POSITIVE GROWTH AFTER 48 HRS AND OTHERS NOT AT ALL. THIS DOES NOT MEET THE DESIRED PARAMETERS OF A BIOLOGICAL INDICATOR.
ON 2/11/94 RPTR HAD A MITRAL VALVE (ARTIFICIAL HEART VALVE) IMPLANTED AND ON 2/7/96 SHE WAS UPDATING HER COMMERCIAL MEDICAL INFO ALERT CO. THEY ASKED HER FOR THE MODEL AND SN OF HER HEART VALVE. SHE DID NOT KNOW IT BUT THE WOMAN SHE WAS SPEAKING TO SAID THAT THERE IS AN FDA REQUIREMENT THAT THE HOSP/SURGEON REPORT THIS TO THE SURGEON WHO REFERRED HER TO THE MEDICAL RECORDS AT THE HOSP. SHE SPOKE WITH THE MEDICAL RECORDS PEOPLE AND THEY FOUND A STICKER IN HER FILE WITH TWO NUMBERS ON IT. SHE THEN CALLED THE MFR WHO CHECKED THEIR DATA BASE AND STATED THAT THIS WAS A MITRAL VALVE BUT THAT THIS VALVE WAS NOT REPORTED TO HAVE BEEN IMPLANTED BUT WAS IN THEIR RECORDS AS STILL ON THE MARKET. THIS WAS ON 2/9/96 SO THE MFR TOOK THE INFO FROM HER AND PUT IT INTO THEIR DATABASE AND SENT HER A CARD. RPTR WANTS FDA TO INVESTIGATE THIS PROBLEM AS SHE FEARS THAT THIS HOSP HAS NO SYSTEM TO ASSURE COMPLIANCE AND MAY HAVE FAILED TO REPORT MANY OTHER SUCH DEVICES AS WELL.
THE BUILT-IN CURING LIGHT ASSEMBLY HAS, ON OCCASION, PRODUCED POWER SURGES WHICH, IN TURN, CAUSES THE VOLTAGE REGULATOR ON THE BOARD TO OVERLOAD. THIS CAUSES FUSE 8 IN THE CHAIR'S POWER TO BLOW. THIS FUSE IS IN LINE WITH THE 6V POWER SUPPLY NEEDED TO OPERATE THE CURING LIGHT FAN MOTOR AND THE HEATED TUBING CIRCUIT. THEREFORE, WHEN THE FUSE BLOWS, NEITHER THE CURING LIGHT OR THE HEATED SYRINGE (IF APPLICABLE) WILL FUNCTION.
FACILITY TRIED SEVERAL PAIRS OF THESE CRUTCHES AND EITHER BROKE THE SCREWS OR THE WOOD LEGS TRYING TO ASSEMBLY THEM. THE TOP PART OF THE CRUTCH APPEARS TO BE TOO NARROW, WHEN THE HAND PIECE IS INSERTED, ONE HAS TO FORCE THE LEGS TOGETHER AT THE BOTTOM. THE PRESSURE APPLIED TO BRING THE BOTTOM TOGETHER BREAKS THE CRUTCH. FACILITY FEELS THIS IS A POTENTIAL SAFETY HAZARD TO THE PT AS THE CRUTCH IS UNDER A LOT OF PRESSURE IF ONE COULD ASSEMBLE THEM.
DEFECTIVE CRUTCHES. THEY DO NOT HAVE THE PROPER ANGLE FOR ASSEMBLY. WHEN ASSEMBLED, THEY BREAK. FACILITY HAS THEM BROKEN (NEW) IN THE BAG.
CRUTCHES APPEAR TO BE LACQUERED AFTER THE HOLES FOR THE SCREWS ARE DRILLED AND THE SCREWS INSERTED. ONCE THE SCREWS ARE REMOVED AND THE CRUTCHES ADJUSTED, THE BOTTOM OF THE CRUTCH SPLITS AND BREAKS. THIS HAS THE POTENTIAL FOR CAUSING GREATER INJURY TO THE PT.
CRUTCHES ARE CRACKED AND BROKEN AT THE POINT WHERE THE HANDLE IS MOUNTED TO THE CRUTCH FRAME. WHEN WEIGHT IS APPLIED TO THE ONES WHICH ARE NOT CRACKED, THEY BOW IN THE MIDDLE AND BECOME UNSTABLE. IT APPEARS THE MATERIAL USED IS TOO BRITTLE AND LIGHT FOR THIS TYPE OF APPLICATION.
USER HAS EXPERIENCED 5 EPISODES OF HIS NEW TANNING BEDS FAILING TO TERMINATE EXPOSURES. HE OWNS 35 BEDS. THE 5 NEWEST OF THESE BEDS ARE EQUIPPED WITH A NEW STYLE "SEALED" CONTACTOR. BED #1 FAILED TO TERMINATE EXPOSURE ON 2/28 AND AGAIN ON 3/17/96. BED #2 FAILED TO TERMINATE EXPOSURE ON 3/8/96. CONTACTORS WERE REPLACED ON ALL 5 NEW BEDS BY THE MFR ON 3/21/96. BED #2 FAILED TO TERMINATE EXPOSURE AGAIN ON 4/2/96.
MECHANICAL FAILURE. POSSIBLE INJURY OR DEATH TO PT WHEN EQUIPMENT IN USE. THE UNIT'S MOTOR CONTROL ASSEMBLE FAILED DURING USE, CAUSING THE UNIT TO LOOSE CONTROL OF THE TABLE TOP, WHICH COULD RESULT IN THE PT BEING DROPPED WHEN IN USE. A LOCKPLATE FASTENER THAT SECURES THE TILT CYLINDER TO THE CYLINDER KNUCKLE WAS LOOSE. EXAMINATION OF THE LOCKING MECHANISM REVEALED THE HEX SCREWS COMPLETELY LOOSE ALLOWING THE CYLINDER TO UNSCREW ITSELF FROM THE CYLINDER KNUCKLE. THE MOTOR CONTROL ASSEMBLY CONSISTING OF THE TILT CYLINDER ASSEMBLY IS THE PROBLEM AREA. A LOOSE LOCK PLATE FASTENER THAT SECURES THE TILT CYLINDER TO THE CYLINDER KNUCKLE IS AT FAULT.
COMPLAINANT STATED SHE OPENED BOTTLE OF SOLUTION ON 1/30 FOR HER SON AND SAFETY SEAL WAS INTACT. HER SON POURED SOLUTION INTO LENSE CASE AND HE SOAKED HIS CONTACTS OVERNIGHT. AT 7:00 AM NEXT DAY WHEN HE PLACED THE LEFT LENS IN HIS EYE, HE SHOUTED HIS EYE WAS BURNING. COMPLAINANT TOOK LENSE AND PLACED IT WITH MORE SOLUTION AND ENZYME TABLES IN ANOTHER CASE TO SOAK/CLEAN WHEN COMPLAINANT NOTICED THE SOLUTION WAS PINK IN COLOR COMPLAINANT THEN FOUND THE SOLUTION IN THE 12 OZ BOTTLE SOLUTION WAS PINK IN COLOR AND NOT CLEAR AS IT NORMALLY SHOULD BE. THIS BOTTLE WAS PURCHASED AT THE END OF DEC 1995 AND NOT OPENED UNTIL 1/30/96.
PT RECEIVED A SEVERE BURN IN THE MOUTH FROM A DENTAL HANDPIECE. THE UNIT OVERHEATED FROM BAD BEARINGS CAUSING OPERATING TEMP TO CAUSE THE BURN.
CURETTE IS INAPPROPRIATE DUE TO ITS SHANK BEING TOO LONG CAUSING TRAUMA TO SURROUNDING TISSUE. THE PROPHY TECHNICIANS ALSO HAVE DIFFICULTY PLACING THE INSTRUMENT BETWEEN THE TEETH (DUE TO SHANK BEING TOO WIDE) THUS CAUSES PT DISCOMFORT AND DOES NOT ALLOW ADEQUATE CLEANING DUE TO INABILITY TO ACHIEVE PROPER ANGLE OF SHANK TO TOOTH.
HUSBAND HAD RPTR'S DEVICE IMPLANTED IN HIS EYE FOR RETINAL REATTACHMENT 11 YEARS AGO. RECENT DR VISIT CONFIRMED THAT THE PRODUCT WAS DISINTEGRATING AND COULD NOT BE REMOVED SURGICALLY WITHOUT NERVE DAMAGE TO THE EYE.
ON 4/10/96 AN ADMIXTURE WAS PREPARED CONTAINING 225ML OF MORPHINE SULFATE 40 MG/ML. IT WAS PLACED IN A PLASTIC BAG AND HEAT-SEALED, THEN DELIVERED TO THE HOSPICE CARE CENTER ON 4/10/96 WHEN INVENTORYING MEDICATIONS, THE NURSE FOUND THAT THE BAG HAD LEAKED OUT. RPTR EVALUATED THE BAG AND FOUND A "SLIT" OR "CRACK" 2 INCHES LONG AT ONE SIDE OF TEH BAG ALONG THE SEAM.
DURING BONE SCAN (WITH PT ON TABLE) OPERATOR NOTICED SMOKE COMING FROM UNIT. PT REMOVED (UNHARMED) AND UNIT TURNED OFF. CPU BOARD AND VIDEO MONITOR BOARD EVIDENCED CHARRING AND MELTDOWN DUE TO OVERHEATING. (*)
TUBING OVER CASSETTE WHERE PUMPING MECHANISM WORKS IS VERY FLEXIBLE. IF LOADED INCORRECTLY, TUBING MAY BE PUSHED ASIDE AND PINCHED OFF. RESULT: PUMP READS GREATER QUANTITY INFUSED THAN WHAT ACTUALLY USED. MULTIPLE ERRORS HAVE OCCURRED. (LACK OF PAIN CONTROL)
PT WAS GETTING OUT OF BED WITH ASSISTANCE. SHE USED THE IV STAND FOR SUPPORT AND THE SUPPORT BROKE CAUSING THE PT TO FALL TO THE FLOOR AND HIT HER HEAD. THERE IS NOW ATTORNEY INVOLVEMENT.
12 MM SCREW BROKE OFF IN SKULL AT 6 MM; 1/2 MM OUT OF SKIN AND 5 MM INTO SKULL WHILE BEING SCREWED IN. STUMP LEFT IN COULDN'T GET OUT. A 2ND SCREW 3 MM BEHIND IT HAD TO BE PLACED. PROCEDURE WAS AS FOLLOWS - ENDOSCOPIC BROW LIFT WITH BILATERAL PTOSIS REPAIR.
PT C/O PAIN AT INFUSION SITE AND FOUND SMALL BURRS AT THE NEEDLE END. UPON INSPECTION OF OTHER NEEDLES, SHE FOUND THAT THEY WERE DULL AS PERHAPS THEY WERE NOT POLISHED TO REMOVE ANY IMPERFECTIONS.
HOME CARE PT DEVELOPED A LEAK IN CATHETER AND WHEN HOME CARE NURSE WAS UNABLE TO REMOVE CATHETER, PHYSICIAN WAS CALLED. ARRANGEMENTS WERE MADE FOR PT TO BE TAKEN TO HOSP AS AN OUTPATIENT THE NEXT MORNING (4/15) TO HAVE CATHETER REMOVED AND REPLACED. THIS WAS UNABLE TO BE DONE AND THE CATHETER HAD TO BE SURGICALLY REMOVED. PT HAD TO BE HOSPITALIZED OVERNIGHT FOLLOWING SURGERY.
STENT WAS CHECKED PRIOR TO INSERTION, THE SHEATH MOVED FREELY. AFTER INSERTION INTO THE PT THE PHYSICIAN WAS UNABLE TO ADVANCE THE STENT THROUGH THE SHEATH. THE SYSTEM WAS REMOVED FROM THE PT. THE SYSTEM WAS CHECKED AGAIN, THE STENT COULD NOT BE ADVANCED THROUGH THE SHEATH.
END OF SIDE RAIL MISSING PLASTIC GUARD AT END OF RAIL. EXPOSED END OF RAIL NOTED TO HAVE BLOOD ON IT. PT FOUND IN BED WITH LEFT POSTERIOR CALF LACERATION 6-7 CM IN LENGTH. REQUIRED SUTURES. BED WAS NOT IDENTIFIED EXCEPT FOR CO NAME. NO ID OR SERIAL NUMBER RECORDED FROM NURSE WHO REPORTED THE PT INJURY.
FIRST TIME BALLOON WAS INFLATED IT BURST.
OVERSEDATION REQUIRING INTERVENTION AND TRANSFER TO ICU. RPH NOTIFIED 4/8; HISTORY ALREADY CLEARED ON PUMP. PRELIMINARY TEST BY RPH: PUMP SEEMED OK. SECOND RPH TESTED PUMP ON 4/15: SEEMED OK. BIOMED CALLED ON 4/22. PRELIMINARY TEST - "PUMP IS OK." TOOK PUMP ON 4/23 FOR FURTHER TESTING. INCIDENT REPORT TO MFR 4/22. (TELEPHONE). BIOMED RETURNED PUMP 5/1. "SATISFACTORY CONDITION WITHIN FACTORY SPEC."
DOUBLE LUMEN PORT LEAKING AROUND NEEDLE'S OVER WEEKEND 4/13, 4/14. ARM SWOLLEN/CLOTTED AROUND CATH TIP. PORT EXPLANTED 4/18.
BILATERAL CAPSULAR CONTRACTURE. REMOVAL BILATERAL BREAST IMPLANTS.
DOUBLE LUMEN PORT LEAKING AROUND NEEDLES OVER 4/17, 4/18. ARM SWOLLEN, CLOTTING AROUND CATH TIP. PORT EXPLANTED 4/19.
BILATERAL SILICONE BREAST IMPLANTS INTACT, PT WANTED LARGER IMPLANTS. IMPLANTED 9 YEARS AGO.
CONTRACTURE WITH RUPTURE OF SILICONE BREAST IMPLANTS (BILATERAL).
CORNEAL ULCER OD. ROUND IN SHAPE 3 MM HORIZONTALLY/2 MM VERTICALLY. TREATED WITH CILOXAN AND HOMATROPINE. RESOLVED 4/2/96.
THERE IS NO 510K SUBMISSION EVEN IF THE MFR CLAIMS THERE IS. MFR'S ADVERTISMENT IMPLIES "IT IS FDA CERTIFIED FOR USE IN THE US" BUT IT HAS NOT BEEN APPROVED BY THE FDA. THE DEVICE HAS SAFETY PROBLEMS WITH IRRADIATING BLOOD. ONE OF THE SAFETY PROBLEMS IS DAMAGE TO THE DNA. THE DEVICE IS SIGNIFICANTLY DIFFERENT FROM THE OLD DEVICE ON THE MARKET. THIS TECHNICAL DIFFERENCE MAKES IT UNSAFE. THE PRODUCT LABELING MAKES CLAIMES THAT CANNOT BE PROVEN. PT IS USUALLY HOOKED TO THE ADMINISTRATION SET AND BLOOD FLOWS THROUGH THE DEVICE AND THAN GOES TO THE BOTTLE AND IT IS PUMPED BACK TO THE PT. THEREFORE, BEING EXPOSED TO ULTRAVIOLET LIGHT SOURCE.
UNABLE TO DEFLATE FOLEY CATHETER BALLOON.
PT WITH HISTORY OF BREAST CA, BILATERALLY; MASTECTOMIES WITH PLACEMENT OF SILICONE IMPLANTS. PT NOTED TO HAVE SEVERE CAPSULAR CONTRACTURE ON THE LEFT AND RIGHT SIDE WAS NOTED TO BE ONE INCH LOWER THAN THE LEFT IMPLANTS. BILATERAL REPLACEMENT WITH SALINE IMPLANTS.
41-YR-OLD MALE W/PREVIOUS AICD PLACEMENT. CC HOSPITALIZED EARLY 2/96 FOR RECURRENT SHOCKS FROM AICD. SHOWED VENTRICULAR ARRYTHMIAS AND HYPOKALEMIA. K+ CORRECTED. AICD BATTERY SHOWED END-OF-LIFE INDICATOR AND WAS REPLACED. A CHECKUP DEVICE SHOWED OVERSENSING, SUGGESTING LEAD FAILURE. PT ADMITTED FOR POSSIBLE LEAD REVISION. LEAD FOUND TO BE FRACTURED ON 2/28/96. LEAD EXPLANTED 2/28/96.
S/P MASTECTOMY, BIL IMPLANTS PLACED 3/8/96. LEFT IMPLANT BEGAN TO DEFLATE ABOUT 1 YR AGO - CUSTOM MADE IMPLANTS. UPON REMOVAL IMPLANT NOTED TO BE ALMOST COMPLETELY DEFLATED WITH ONLY SMALL AMOUNT OF YELLOWISH FLUID IN IMPLANT. NOTE: QUALITY MANAGEMENT DID NOT BECOME AWARE OF EVENT UNTIL 3/13/96. IMPLANT DATE 3/8/96.
SINGLE LUMEN PICC IV LINE SEPARATED AT HUB WITH IV LINE REMAINING IN PT'S VEIN. REQUIRED A CUTDOWN TO RETRIEVE IV CATHETER.
AFTER INSERTION OF EPIDURAL CATHETER IN THE EPIDURAL SPACE IT WAS NOTICED THAT BLOOD WAS ASPIRATED. THE CATHETER WAS WITHDRAWN AND IT WAS NOTICED THAT RESISTANCE WAS MET. THE PT WAS RE-POSITIONED AND THE CATHETER WAS ATTEMPTED TO BE RETRIEVED AGAIN. THE CATHETER'S DISTAL END (APPROX 1/2 INCH TO 1 INCH BROKE OFF IN THE PT.
THE PT HAS HAD BURNING PAIN IN THE BREASTS IN THE LAST YEAR AROUND THE BREAST IMPLANTS AS WELL AS A HISTORY OF LEFT AXILLARY HIDRADENITIS. THE PT UNDERWENT LEFT HIDRADENITIS EXCISION IN 1989: HOWEVER, SHE CONTINUED TO HAVE BURNING AND ITCHING IN THE LEFT AXILLA. IN 1989, THE PT ALSO HAD BURNING PAIN IN THE BACK IN THE BRA LINE AREA. OTHER SYMPTOMS THE PT HAS HAD INCLUDE FATIGUE, DRY MOUTH, NUMBNESS IN FEET INTERMITTENTLY. BOTH IMPLANTS ARE INTACT; HOWEVER, ULTRASOUND SHOWS SILICONE LYMPHADENOPATHY IN AT LEAST ONE LYMPH NODE AND THIS LYMPH NODE WILL BE NEEDLE-LOCALIZED PREOPERATIVELY. BECAUSE OF SILICONE MIGRATION, TENDERNESS AROUND THE IMPLANTS AND SYMPTOMS OF LOCAL PAIN THAT MAY BE RELATED INFLAMMATORY EFFECTS OF SILICONE AS WELL AS SYSTEMIC SYMPTOMS THAT MAY BE RELATED TO SILICONE, IT IS MEDICALLY NECESSARY TO REMOVE BOTH IMPLANTS TO DO A TOTAL CAPSULECTOMY AS WELL AS REMOVAL OF THE TENDER LYMPH NODES WHICH WILL BE LOCALIZED BY NEEDLE LOCALIZATION.
THE PT IS A 47-YR-OLD WOMAN WHO HAD LEFT BREAST CANCER IN 1982, AND UNDERWENT A LEFT MODIFIED RADICAL MASTECTOMY. A LEFT BREAST RECONSTRUCTION DONE IN 6/83. ONE AND A HALF YEARS AGO, THE PT DEVELOPED ACHING PAIN IN THE LEFT UPPER BREAST AREA AS WELL AS LOWER EXTREMITY MYALGIAS WHICH HAVE GOTTEN BETTER. THE PT HAS A DEFINITIVE INTRACAPSULE RUPTURE OF THE PRESENT IMPLANT.
PT HAD CAPSULAR CONTRACTURE, RUPTURED IMPLANTS, ARTHRITIS AND SUBSEQUENT EXPLANTATOIN OF IMPLANTS.
THE PT IS A 46-YR-OLD WHITE FEMALE WHO, IN 1978, HAD BILATERAL BREAST AUGMENTATION USING GEL-FILLED IMPLANTS. SHE DEVELOPED WEIGHT GAIN, RASH ON FACE, CHEEKS, NOSE, AND FOREHEAD AND ACNE ON THE FACE AND NECK AREA. SHE HAS A LOSS OF SHORT-TERM MEMORY IN THE 1980'S AND AT THE PRESENT TIME, SHE HAS A TERMENDOUS AMOUNT OF NECK TIGHTNESS WITH HEADACHE AND PAIN, ARTHRALGIAS IN THE HIP SHOULDERS AND ELBOW REGIONS AND MUSCLE SPASMS. THE PT ALSO HAS FATIGUE AND DEPRESSION. SHE HAS BREAST PAIN IN THE AXILLARY, STERNAL AND NIPPLE AREA AND DEEP IN THE BREAST, DRY EYES AND NUMBNESS AND TINGLING IN HER HANDS. XEROMAMMOGRAM AND ULTRASOUND CONFIRM BILATERAL RUPTURED IMPLANTS WITH EXTRACAPSULAR RUPTURE ON THE LEFT. THE PT ALSO HAS MELASMA IN THE CHEEKS AND SKIN AREA. SHE HAS MULTIPLE TENDER POINTS IN THE "CLASSICAL FIBROMYALGIA TRIGGER AREA." BECAUSE OF BILATERAL RUPTURED IMPLANTS, BREAST PAIN AND SYSTEMIC SYMPTOMS THAT MAY BE BOTH IMPLANTS. TOTAL CAPSULECTOMY IS MEDICALLY NECESSARY BECAUSE OF RUPTURE.
FIFTY-NINE YEAR OLD FEMALE ADMITTED FOR REMOVAL OF BILATERAL BREAST IMPLANTS. PT HAS NOTED CHANGE IN LEFT PROSTHESIS. LEFT PROSTHESIS WAS RUPTURED.
THE PT IS A 43-YR-OLD WHITE FEMALE WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 1978 USING DOUBLE-LUMEN-TYPE IMPLANTS. THE PT HAD CAPSULAR CONTRACTURE ON THE LEFT REQUIRING CLOSED CASPULOTOMY THREE TIMES. PAIN RADIATES TOWARD THE AXILLA IN BOTH BREASTS. OVER THE LAST FIVE YEARS, THE PT HAS NOTED FATIGUE AND PAIN IN THE LEFT BREAST. THERE IS TENDERNESS IN THE MUSCLES AND SHE HAS BEEN DIAGNOSED WITH FIBROMYALGIA. THERE IS ALSO A SHORT-TERM MEMORY DEFICIT AND BLADDER IRRITABILITY PROBLEMS. THE XEROMAMMOGRAM AND ULTRASOUND EXAMINATION SHOWS THAT THE RIGHT IMPLANT IS INTACT; HOWEVER, THE LEFT SIDE HAS LOSS OF SALINE SHELL. AS A RESULT OF SIGNIFICANT LOCAL PAIN AS WELL AS SIGNIFICANT RETRACTION OF THE LEFT AND LOSS OF IMPLANT INTEGRITY ON THE LEFT, THE PT DESIRES IMPLANT REMOVAL AND MASTOPEXY.
THE PT IS A WOMAN WHO IN 1980 HAD BILATERAL SUBCUTANEOUS MASTECTOMY FOR PAINFUL FIBROCYSTIC DISEASE. SHE WAS IMMEDIATELY RECONSTRUCTED WITH SALINE IMPLANTS. IN 1981, BECAUSE OF RECURRENT CONTRACTURE, THESE IMPLANTS WERE CHANGED TO A SECOND MFR'S DOUBLE-LUMEN IMPLANTS. IN 1985, BECAUSE FOR RECURRENT CONTRACTURE, THESE IMPLANTS WERE REPLACED WITH POLYURETHANE BREAST IMPLANTS. HOWEVER, DUE TO CONTROVERSY OVER THESE IMPLANTS AND CONTRACTURE, IN 1993, THE OLD IMPLANTS WERE REMOVED. A TOTAL CAPSULECTOMY WAS DONE. THERE WAS A MASS POSTOPERATIVELY IN THE LEFT BREAST AND THIS SHOWED FOCAL, FOREIGN BODY GRANULOMATOUS REACTION. THESE IMPLANTS WERE PLACED IN 11/94, UNDER THE MUSCLE BECAUSE OF SIGNIFICANT WRINKLING OF THE SKIN. THE PT HAS AN ELEVATED ANA. SHE HAS FREQUENT BAD MIGRAINES. SHE HAS MUSCLE SPASMS. THE IMPLANTS ARE VERY TENDER TO PALPATION. THERE IS PAIN IN THE STERNUM. BOTH IMPLANTS ARE CLASS 4 CAPSULAR CONTRACTURE. BECAUSE OF CONTRACTURE, PAIN, PREVIOUS RUPTURE AND SILICONE ADENOPATHY AS WELL AS SYSTEMIC SYMPTOMS, IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS. TOTAL CAPSULECTOMY IS NECESSARY BECAUSE THE CAPSULE CONTAINED SILICONE OR INFLAMMATION RESPONSIBLE FOR PT'S PAIN. IMPLANT DATE 2/4/93.
SURGEON PLACED AND HAD SEWN THE VALVE IN PT, NOTICED VALVE LEVER WAS BROKEN, ONE PARTICLE RETRIEVED, POSSIBLE ONE STILL REMAINS. PT EXPIRED FOLLOWING DAY, CAUSE UNKNOWN. CORONER'S CASE.
UNDERWENT EXPLANTATION OF DEFLATED SALINE IMPLANT, LEFT BREAST. HOLE NOTED IN EXPLANTED DEVICE.
BILATERAL IMPLANTS IN 4/5/78. CAPSULAR CONTRACTIONS AND BILATERAL RUPTURED IMPLANTS.
BILATERAL IMPLANTS IN 1980. RECENT MAMMOGRAM SHOWED RUPTURED IMPLANTS. AT TIME OF SURGERY BOTH IMPLANTS RUPTURED.
THE PT IS A 48-YR-OLD WOMAN WHO HAD BILATERAL BREAST AUGMENTATION IN 3/89 UNDER THE MUSCLE. THE PT DEVELOPED RIGHT SIDED CAPSULAR CONTRACTURES. SHE NOTED RIGHT HAND SWELLING AND STIFFNESS AS WELL AS SOME LEFT TEMPOROMANDIBULAR JOINT CRACKLE AND PAIN. BOTH IMPLANTS ARE INTACT. HOWEVER, SHE WAS RECENTLY NOTED TO DEVELOP THROMBOCTOPENIA, LEUKOPENIA, INCREASED COMPLEMENT C3 AND INCREASED ANA AT 1:320 TITER. SHE WAS DIAGNOSED WITH UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE. AS A RESULT OF THIS ATYPICAL CONNECTIVE TISSUE DISEASE WITH SEROLOGIC CHANGES, CAPSULAR CONTRACTURE, IT IS MEDICALLY NECESSARY TO REMOVE BOTH IMPLANTS.
THE PT HAD BILATERAL BREAST AUGMENTATION IN 2/84. THE PT WAS VERY ENERGETIC BEFORE IMPLANTS AND HAS A HISTORY OF RAYNAUD'S. IN 1988, SHE HAD THE ONSET OF CHRONIC FATIGUE. THEN SHE ALSO DEVELOPED BODY PAINS, ESPECIALLY AFTER BACK SURGERY FOR RUPTURED DISK. SHE ALSO HAS RIGHT BREAST PAIN AND NUMEROUS ALLERGIES FOR WHICH SHE TAKES SELDANE. ULTRASOUND AN XEROMAMMOGRAM EXAMINATION DEMONSTRATES BILATERAL IMPLANT RUPTURE RIGHT SIDE DEFINITIVE EXTRACAPSULAR RUPTURE, LEFT SIDE INTRACAPSULAR. THERE ARE FIVE SILICONE LYMPH NODES IN THE RIGHT AXILLA AND ONE DEEP SILICONE NODE IN THE LEFT AXILLA. BECAUSE OF RUPTURE, SILICONE LYMPHADEMOPATHY, BREAST PAIN AND SYSTEMIC SYMPTOMS THAT MAY BE ASSOCIATED WITH HER IMPLANTS, IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS.
THE PT HAD BILATERAL BREAST AUGMENTATION IN 1958 USING SILICONE GEL FILLED BREAST IMPLANTS. THE RIGHT SIDE WAS REPLACED IN 1969 DUE TO LEAKAGE AND DEFORMITY. THE PT DEVELOPED ARTHRITIS IN 1971 AND HAS PROGRESSED WITH EROSIONS OF JOINTS IN THE HANDS. SHE DEVELOPED HEARING LOSS FROM TREATMENT OF ARTHRITIS. ULTRASOUND EXAMINATION AND XEROMAMMOGRAM EXAMINATION DEMONSTATES CALCIFICATION OF BOTH BIOLOGICAL CAPSULE. THE LEFT SIDE IS AN EXTRACAPSULAR RUPTURE WITH SILICONE GRANULOMA AT THE 8:00O'CLOCK POSITION 5.0 CM FROM THE NIPPLE. IN ADDITION, THERE IS MULTIPLE SILICONE IN THE LYMPH NODES IN THE RETROPECTORAL SPACE BILATERALLY AS WELL AS IN THE LEFT AXILLA AND LEFT INTERNAL MAMMARY CHAIN. TOTAL CAPSULECTOMY IS MEDICALLY NECESSARY BECAUSE THE CAPSULE CONTAINS SIGNIFICANT AMOUNTS OF CALCIFICATION.
PENILE IMPLANT PROCEDURE PERFORMED IN 3/91. IMPLANT FRACTURED MID-PORTION. PT ADMITTED 3/1/96 FOR REMOVAL OF DEFECTIVE IMPLANT, REINSERTION OF PENILE IMPLANT.
SEVENTY-THREE-YEAR-OLD MALE STATUS POST CABG AND AORTIC VALVE REPLACEMENT 4 YERS AGO WAS ADMITTED FOR VALVE REPLACEMENT. THERE HAS BEEN PROGRESSIVE DETERIORATING AORTIC VALVE FUNCTION OVER THE LAST YEAR AND THE PT HAS HAD INCREASING SOB AND CHF. RECENTLY THESE SYMPTOMS HAVE BECOME EXCESSIVELY SEVERE.
THE PT IS A 54-YR-OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 10/79 ABOVE THE MUSCLE. THE PT DEVELOPED "RECAL" BURNING SHORTLY AFTER THAT AND HAD REQUIRED MULTIPLE TREATMENTS AND IS TAKING ELAVIL AND LIBRIUM FOR RELIEF. SHE HAS HAD NERVE BLOCKS ETC. THE PT HAS HAD DECREASED MEMORY CAPACITY, DRY EYES, DRY MOUTH, DRY VAGINA, FATIGUE. ON PHYSICAL EXAMINATION, SHE HAS A CLASS IV CONTRACTURE ON BOTH SIDES. XEROMAMMOGRAM SHOWS, ON THE LEFT SIDE, A LARGE EXTRUSION OF THE CAPSULE INDICATING DEFINITIVE RUPTURES. BECAUSE OF RUPTURE, CONTRACTURE, LOCAL PAIN AND SYSTEMIC SYMPTOMS, IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS. TOTAL CAPSULECTOMY IS MEDICALLY NECESSARY BECAUSE OF TEH RUPTURE.
THIS PT HAD UNDERGONE BILATERAL BREAST AUGMENTATION IN THE PAST, AND NOW HAD FIBROSIS AROUND THE IMPLANTS AND IN ADDITION, HAD MAMMOGRAPHIC EVIDENCE THAT THE IMPLANTS HAD RUPTURED.
PT HAD AUGMENTATION USING THE DEVICE UNDER THE MUSCLE. THE PT HAS HAD CHEST WALL TENDERNESS ESPECIALLY ON THE RIGHT SIDE FOR A NUMBER OF YEARS. SHE HAS HAD MILD FATIGUE, DRY EYES, DRY MOUTH, MYALGIAS AND RAYNAUD'S SINCE IMPLANTATION. SHE HAS A CAPSULAR CONTRACTURE ON THE LEFT. BECAUSE OF CHEST WALL PAIN AND SYSTEMIC SYMPTOMS THAT MAY BE ASSOCIATED WITH THE BREAST IMPLANTS, IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS. A TOTAL CAPSULECTOMY IS MEDICALLY NECESSARY BECAUSE THE CAPSULE CONTAINS SILICONE, TO WHICH THE PT MAY BE REACTING.
MSO4 PCA INITIATED ON PT AT 2215. RN ON 11-7 CLEARS # OFF PUMP OF 2.4CC. MSO4 CONCENTRATION 1MG=1CC. PT HAS BEEN USING PCA; HAS BEEN LOCKED OUT TWICE. HISTORY OF PCA RECEIVED AND DOSAGE ENTERED INTO PCA TO DELIVER 0.1 MG INSTEAD OF 1.0 MG. DOSAGE CORRECTED.
PT REPORTS DIRECT TRAUMA TO RIGHT BREAST ON 1/1/96 AND GRADUAL ENLARGEMENT SUBSEQUENTLY. SALINE BREAST IMPLANT (RIGHT) WAS REMOVED AND REPLACED WITH ANOTHER SALINE IMPLANT.
A 48-YR-OLD FEMALE HAD REMOVAL OF SILICONE BREAST IMPLANTS ON 7/17/95. THESE WERE REPLACED WITH SALINE IMPLANTS. THE PT WAS RETURNED TO THE OR ON 4/4/96 FOR REMOVAL AND REPLACEMENT OF LEAKING LEFT BREAST IMPLANT.
A 67-YR-OLD FEMALE WAS ADMITTED FOR BILATERAL SILICONE GEL BREAST EXPLANTATION. THE PT HAD UNDERGONE BILATERAL MASTECTOMY WITH BREAST IMPLANTS IN THE PAST. THE PT HAD BEEN EXPERIENCING SEVERE, UNREMITTING PAIN IN THE CHEST WALL AS WELL AS GROSS ASYMMETRY AND DISTORTION. BOTH IMPLANTS WERE RUPTURTED.
PT UNDERWENT CATARACT EXTRACTION WITH INSERTION OF AN INTRAOCULAR IMPLANT. THE SURGERY WAS UNEVENTFUL. UPON THE POST-OP APPOINTMENT THE FOLLOWING DAY, IT WAS DISCOVERED THAT THE PT HAD APPARENT METAL FRAGMENTS IN HER OPERATIVE EYE. THE PT SUFFERED NO ILL EFFECTS OR VISUAL LOSS AT THE TIME. THIS WAS REPORTED TO FACILITY AND EQUIPMENT USED FOR PROCEDURE WAS REMOVED FROM WORK AND RETURNED TO MFR FOR EVALUATION.
PT HAD GASTROSCOPY WITH ESOPHAGEAL DILATION. SPRING TIP ON GUIDE WIRE WAS MISSING. PT WAS SCOPED AND SPRING TIP WAS FOUND IN THE ESOPHAGUS AND WAS REMOVED.
PT JUMPED OUT OF BED AND DISLODGED THE CATHETER FROM THE BLADDER. THE CATHETER BECAME LODGED IN THE PT'S PENIS. THE CATHETER COULD NOT BE DEFLATED BY THE NURSING STAFF. INTERVENTION BY THE ATTENDING PHYSICIAN WAS REQUIRED TO DEFLATE AND REMOVE THE CATHETER. (*) ADD'L LOT NUMBER 9601001022.
UNDERGOING SURGERY FOR CAD ON 3/13/96. AT END OF CASE - COULD NOT OBTAIN CARDIAC OUTPUTS. MONITOR READ "CATHETER DEFAULT." CATHETER REPLACED.
WENT TO HANG ANTIBIOTIC IN PT'S ROOM, AND IT HAD A HOLE IN THE TUBING. NEW TUBING WAS OUT OF THE PACKAGE AND WAS NEVER CONNECTED TO THE PT.
RESIDENT TRANSFERRING HERSELF TO TOILET; TOILET GRAB BAR ON PT'S LEFT SIDE BROKE OFF AND RESIDENT FELL. THE BARS ARE AN ATTACHMENT TO THE TOILET (COMMODE AND SEAT).
RESIDENT WAS AMBULATING IN THIS WALKER. HE WAS ABLE TO TURN TO SIDE IN DEVICE, LEAN BACKWARDS AND PULL DEVICE OVER ON TOP OF HIM. HE CONSEQUENTLY HIT HIS HEAD ON THE FLOOR RESULTING IN A SUBDURAL HEMATOMA.
WHILE INSERTING THE GUIDE WIRE FOR THE CATHETER, RESISTANCE WAS FELT BY THE PHYSICIAN. HE RETRACTED THE GUIDE WIRE TO FIND THAT THE WIRE WRAP AROUND THE GUIDE WIRE WAS UNCOILED AND THAT A PORTION OF THE GUIDE WIRE REMAINED IN THE PT. X-RAY CONFIRMED THE EVENT AND A SURGEON WAS CONSULTED AND REMOVAL OF THE REMAINING SECTION OF THE GUIDE WIRE WAS SCHEDULED.
PT TAKEN TO OR ON 2/25/96 FOR EXPLORATORY LAPAROTOMY FOR POSSIBLE INTUSSUSCEPTION. PRE-OPERATIVELY, ANESTHESIOLOGIST ATTEMPTED TO INSERT A TRIPLE LUMEN CATHETER, HOWEVER, MET RESISTANCE AFTER INSERTING A SHORT DISTANCE. CATHETER AND GUIDE WIRE WERE REMOVED. A SECOND ATTEMPT WAS MADE USING A LONGER CATHETER. AGAIN, RESISTANCE WAS MET AND CATHETER AND GUIDE WIRE REMOVED. A CVP LINE WAS ULTIMATELY PLACED IN THE EXTERNAL JUGULAR VEIN. GUIDE WIRE WAS REMOVED AFTER SUCCESSFUL PLACEMENT. ON 3/1/96, AN "OPAQUE WIRE" IN THE DISTAL INFERIOR VENA CAVA WAS NOTED ON THORAX CT SCAN. ON 3/11/96 A SKELETAL SURVEY WAS PERFORMED WHICH REVEALED A GUIDE WIRE IN THE INFERIOR VENA CAVA. ON 3/12/96, THE GUIDE WIRE WAS REMOVED FROM THE INTERNAL ILIAC VEIN VIA RIGHT GROIN APPROACH BY AN INTERVENTINAL RADIOLOGIST. RETRIEVAL WAS WHAT APPEARS TO BE A RETAINED PORTION OF GUIDELINE APPROX 4 INCHES IN LENGTH. EXTENSIVE RESEARCH TO IDENTIFY MFR OF MEDICAL DEVICE HAS BEEN UNSUCCESSFUL. ACCORDING TO PT'S ATTENDING PHYSICIAN, PT DID NOT SUFFER ANY INJURY AS A RESULT OF RETAINED GUIDE WIRE.
EXPERIENCED 2 EPISODES OF DIZZINESS AND PULSE RATE IN THE 30-40 RANGE. PRESENTED TO ER DURING 2ND EPISODE. EKG SHOWED "NSR WITH 3RD DEGREE HEART BLOCK AND PROBABLE JUNCTIONAL ESCAPE RHYTHM. APPEARS TO BE VENTRICULAR SPIKES APPROPRIATELY OCCURRING AFTER P-WAVES, HOWEVER, THERE IS NO VENTRICULAR CAPTURE NOR DOES THERE APPEAR TO BE ANY APPROPRIATE SENSING AS WELL." PT WAS TAKEN TO THE OR ON 3/22/96 FOR REPLACEMENT LEAD WIRE IMPLANTATION. ORIGINAL LEAD WIRE LEFT IN THE PT.
STENT WOULD NOT ADVANCE OUT OF GUIDING CATHETER IN CORONARY. STENT WAS PULLED OUT OF PT. A SECOND STENT WAS DEPLOYED. NO PT HARM.
DR WAS DOING FIXATION OF LEFT DISTAL HUMERUS SUPRACONDYLAR FRACTURE. TIP OF THE 3.5 MM CANNULATED TAP BROKE OFF IN THE BONE. MD UNABLE TO REMOVE TAP FRAGMENT IN THE FRACTURE SITE DUE TO THE STABLE FIXATION IT HAD ACHIEVED.
PHYSICIAN ATTEMPTED TO DILATE URETHRA. FILIFORM AND FOLLOWERS USED TO BYPASS AND DILATE URETHRAL STRICTURE. FILIFORM BROKEN AND RETAINED IN THE URETHRA. PATHOLOGY REPORT - 29 CM LONG SEGMENT OF PLASTIC WIRE.
AIDE WAS LIFTED USING HAND OPERATED DEVICE FOR MOTOR OPERATED APPLIANCE (CHAIR) WHEN SHE HEARD A POP, SAW A WHITE FLASH AND SMELLED SMOKE. DIAGNOSED WITH FIRST/SECOND ELECTRICAL BURN TO RIGHT HAND.
FOLLOW-UP CHEST X-RAY DETECTED FOREIGN BODY IN THE CHEST WHICH WAS THE WHITE SILICONE TUBING FROM THE LOCKING MECHANISM AND WAS EXPLANTED IN THE OFFICE UNDER LOCAL.
MOBILITY, SORENESS AT THE TIME OF UNCOVERING. DUE TO INCOMPLETE INTEGRATION. REPLACED WITH NEW WIDER IMPLANT.
LACK OF INTEGRATION REPLACED WITH NEW IMPLANT.
PT SUSTAINED FRACTURE OF LEFT FEMUR IN 12/84. ON 12/13/84, OPEN REDUCTION INTERNAL FIXATION WITH MEDIAL DISPLACEMENT OSTEOTOMY WAS PERFORMED UTILIZING A 135 DEGREE ANGLE 8 HOLE SIDE PLATE AND 2 1/4" LAG SCREW. SHE PRESENTED IN ER ON 12/14/95 COMPLAINING OF PAIN IN HER LOWER LEFT EXTREMITY. X-RAYS REVEALED EVIDENCE OF BROKEN LAG SCREW. SUBSEQUENT EVALUATION REVEALED THE PRESENCE OF A SUBCAPITAL FRACTURE OF THE LEFT FEMUR WHICH NECESSITATED SURGERY FOR REMOVAL OF THE COMPRESSION HIP DEVICE FOLLOWED BY INSERTION OF A BIPOLAR ENDOPROSTHESIS.
THE SENSE PACE LEAD WAS CAPPED ON 3/22/96 DUE TO NOISE. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORM TO SPEC.
PT WAS SCHEDULED FOR TURP AND BLADDER STONE REMOVAL. DUE TO THE SIZE OF THE PROSTRATE, SUPRAPUBIC PROSTATECTOMY WAS PLANNED. THE JAWS OF THE DEVICE BECAME MISALIGNED WHILE IN USE. SURGEON WAS UNABLE TO REALIGN IT AND PROCEDURE WAS CONVERTED TO OPEN SURGERY IMMEDIATELY. PT IS RECOVERING.
NEEDLE RETRACTED WHEN CATHETER WAS BEING TWISTED LOOSE. NURSE DID NOT PUSH WHITE BUTTON.
REPROCESSING SINGLE USE BIOPSY FORCEPS. THIS INSTRUMENT HAS ETO GAS. ETO IS NOT RECOMMENDED AND WILL NOT KILL ACTIVE SPORES WITHIN THE BIOPSY FORCEPS. THE STEAM AUTOCLAVE IS THE ONLY RECOMMENDED PROCESS FOR STERILIZING BIOPSY FORCEPS. "IS THIS CO ALLOWED TO REPROCESS A SINGLE USE INSTRUMENT?"
POST-OPERATIVE PT LEANED OVER SIDE RAIL OF STRETCHER TO VOMIT. STRETCHER RAIL, IN UPRIGHT POSITION, AND FELT TO BE LOCKED, FELL DOWN, CAUSING PT TO FALL TO FLOOR. PT WAS ASSESSED BY MDR AND FOUND TO HAVE NO APPARENT INJURY. MFR CONTACTED AND EVALUATED EQUIPMENT. WERE NOT ABLE TO IDENTIFY PROBLEM UNTIL TWO ADD'L NON-PATIENT SITUATIONS OF A SIMILAR NATURE OCCURRED ON 4/2/96. MFR THEN CONTACTED TO EFFECT REPAIR.
TUBING LEAKED AT LAST Y-PORT. MEDICATION INFUSING WAS "ABELECT."
PT COMPLAINS THAT FULL VOLUME TPN NOT INFUSED AND PUMP STOPS BEFORE INFUSION COMPLETE. CHANGES BATTERIES DAILY. PT INSTRUCTED TO CLEAR RES VOL AND INFUSION VOLUME AFTER EACH INFUSION.
1/19/87 HAD TEFLON TMJ IMPLANT PUT INTO RIGHT TMJ. HAD PAIN, CLICKING, BITE PROBLEMS, HEARING PROBLEMS. EARACHE EVER SINCE ALONG WITH OTHER PROBLEMS.
IN 1/95 RPTR STARTED HAVING DIFFICULTY BREATHING, ASTHMA ATTACKS, RHINITIS, SEVERE CAUGHING DAY AND NIGHT. SO SEVERE PT WAS UNABLE TO WORK FOR 2 MONTHS. WATERY EYES, SNEEZING, LOUD, AUDIBLE WHEEZING. NASAL PASSAGES COMPLETELY OCCLUDED. COULD NOT LIE DOWN AND SLEEP AT ALL. COUGHING SO STRONG HAD NO CONTROL OF BLADDER, INCONTINENT OF URINE. LATEX ALLERGIC DISCOVERED 12/95 BY DR. PT IS STILL USING INHALANTS DAILY; ON PREDNISONE PRN AND ALLERGY INJECTIONS MONTHLY.
PT WAS UNDERGOING REMOVAL OF BILATERAL SILICONE BREAST IMPLANTS. LEFT IMPLANT WAS FOUND TO BE RUPTURED UPON EXPLANTATION.
RESPIRATORY THERAPIST REPORTS THAT WHEN A METERED DOSE INHALER IS ATTACHED TO THE DRUG DELIVERY SYSTEM, THE FIT IS SUCH THAT THE METERED DOSE INHALER CANNOT BE ACTIVATED. THEREFORE, THE PT MAY INHALE AS HARD AS THEY WOULD LIKE BUT CANNOT OBTAIN ANY MEDICATION. THERE SEEMS TO BE A DEVICE PROBLEM WITH THE FIT.
PT WAS BEING PROPELLED IN A WHEEL CHAIR, BY A RURAL TRANSIST CO DRIVER, FROM INSIDE THE VAN ONTO THE LIFT OF THE VAN. THE PT FELL OUT OF THE CHAIR ONTO THE LIFT. THE PT SUSTAINED AN INJURY THAT REQUIRED HOSPITALIZATION. THE DRIVER OF RURAL TRANSIST STATED HE "HAD HER SECURED WHILE INSIDE THE VAN, BUT NOT IN THE WHEEL CHAIR GOING DOWN ON THE LIFT."
PUMP WAS IN USE ON 6-DAY-OLD INFANT TO INFUSE IV FLUID. A SIGNIFICANT INFILTRATION OCCURRED WITH NO ALARMS INDICATING OCCLUSION. THIS PUMP WAS LABELED "PEDI" MEANING IT WAS ONE OF HOSP PUMPS SUPPOSEDLY ALTERED TO DELIVER FLUID AT LOWEST POSSIBLE PSI SETTING CONTINUOUSLY IE WITHOUT ADVANCING PRESSURE. THIS INFILTRATION ON INFANT'S FOOT WAS SIGNIFICANT ENOUGH TO CAUSE TISSUE DAMAGE.
FOLEY PLACED TO DRAIN AS DESIGNED. STAFF NOTED LACK OF URINE FLOW WITH THE BLADDER BECOMING FULL. THE BALLOON WHICH HOLDS THE FOLEY IN PLACE WOULD NOT DEFLATE. RESIDENT INSTILLED MINERAL OIL INTO THE FOLEY AND FOLEY REMOVED.
5-MONTH-OLD PT, ADMITTED ON 5/5/96 WITH RULE-OUT "BKP". ON 5/7/96, WHEN NURSES CHECKED OUT THE IV-SITE, THEY NOTICED THAT THE ANGIO CANNULA HAD BEEN DISPLACED FROM THE "YELLOW HOOK" OF THE ANGIO, AND WAS INTO THE PT'S VEIN. PT HAD SURGERY TO REMOVE THE CANNULA FROM THE RIGHT HAND, BY A PERIPHEROVASCULAR SURGEON. PT DOING WELL, DISCHARGED HOME ON 5/10/96.
DURING A PROCEDURE THE WIRE WAS INSERTED INTO A LUMP IN THE PT'S BREAST AND THE NEEDLE BROKE DURING THE MANIPULATION OF THE BREAST DURING SURGERY. THE HOOP ON THE END OF THE WIRE SEPARATED FROM THE ORIGINAL PIECE.
PT SCHEDULED FOR LAPAROSCOPIC CHOLECYSTECTOMY. THE CAMERA PORTION OF THE LAPAROSCOPIC EQUIPMENT MALFUNCTIONED (IMAGE FADED IN AND OUT AND EVENTUALLY DISAPPEARED). THE IMAGE COULD BE REGAINED WITH CONSIDERABLE MANIPULATION OF THE CAMERA CORD, HOWEVER, IT WAS DEEMED NECESSARY TO CONVERT TO AN OPEN CHOLECYSTECTOMY TO ENSURE PT'S SAFETY.
RECURRENT LACK OF PERFORMANCE OF CONTROLS IN KIT FOR BLOOD DONOR SCREENING. NO RESPONSE FROM VENDOR TO TRY TO CORRECT THE PROBLEM. BLOOD DONOR TESTING DONE DAILY WITH REPEATED ASSAY FAILURES. VENDOR ASSUMES NO RESPONSIBILITY FOR LACK OF KIT PERFORMANCE.
A SVC TECH WAS REPAIRING THE CATH LAB SYSTEM. IT WAS REPORTED TO SVC THAT FLUORO WAS "STAYING ON." WHILE TECH WAS CHECKING THE FLUORO FOOT SWITCH (SYSTEM NOT ON AT THIS TIME), A NURSE CAME INTO THE ROOM AND PLACED A CINE FILM CANISTER NOT THE CINE CAMERA. THIS CAUSED THE SYSTEM TO IMMEDIATELY PRODUCE CINE X-RAY. BOTH THE TECH AND NURSE WERE TEMPORARILY EXPOSED AS NEITHER WERE WEARING LEAD. THE TECH PUT ON LEAD AND WENT BACK INTO THE ROOM TO FIND THAT THE CINE FOOT SWITCH WAS THE CAUSE OF THE PROBLEM, NOT FLUORO. FAILURE MODE IS SUCH THAT THE PLASTIC ACTUATORS IN FOOT SWITCH BROKE OFF AND CAUSED THE ACTIVATION. THIS HAS OCCURRED ON MORE THAN ONE OCCASION.
BREAST IMPLANT WAS NOT IN PROPER POSITION. PT'S BODY WAS MUTILATED AND UGLY. PT HAD A LOT OF PAIN. STATED "LEFT IMPLANT IS FLAT AND UNDER THE ARMPIT. RIGHT IMPLANT IS 3B." BECAUSE THERE IS NO SPACE UNDER ARMPIT, IMPLANT IS PUSHING AND CAUSING A LOT OF PAIN. PT SAID "DR WAS DOING AN EXPERIMENT."
PT HAD SURGERY TO REPAIR AN INCISIONAL HERNIA. THE REPAIR WAS DONE USING SUTURE. SHORTLY AFTER THE PT ARRIVED IN THE RECOVERY ROOM, IT WAS NOTED THAT HE HAD A WOUND HEMATOMA AND WAS BLEEDING AT THE SITE. HE WAS RETURNED TO THE OR EMERGENTLY, AND IT WAS NOTED THAT ALL SUTURES HAD BROKEN, CAUSING A WOUND DEHISCENCE. THE MEDICAL DEVICE INCIDENT REVIEW TEAM WAS ABLE TO BREAK THE SUTURE WITH LITTLE EFFORT.
POST STENT DEPLOYMENT, RETRACTION OF THE BALLOON DEVICE AND GUIDE WIRE RESULTED IN SEPARATION OF THE OPAQUE WIRE TIP FROM THE BODY OF THE GUIDE WIRE. MULTIPLE ATTEMPTS TO RETRIEVE THE WIRE WITH SNARES WERE UNSUCCESSFUL.
PT'S PACER FAILED TO SENSE THE PT'S INTRINSIC BEATS. ONE SPIKE FELL ON THE T-WAVE, FOLLOWED BY V-TACH ARREST. PT WAS POST CARDIAC SURGERY AND WAS SUCCESSFULLY CARDIOVERTED WITH NO OTHER SEQUELAE FOLLOWING.
VENTILATOR WAS NOT PUTTING OUT THE CORRECT AIR FLOW VOLUME REQUIRED TO RESPIRATE PT. PT'S ET TUBE WAS REMOVED AND REPLACED UNNECESSARILY TO AFFIRM PT'S AIRWAY WAS PROPER PRIOR TO CHECKING THE VENTILATOR. WHEN THE VENTILATOR WAS CHECKED, IT WAS FOUND TO MALFUNCTION.
ON THE EVENING OF 5/6/95 DIABETIC PT DEVELOPED A TERRIBLE HEADACHE ON THE WAY TO A SOCIAL FUNCTION. AS THIS CAN BE A SIGN OF HIGH BLOOD SUGAR, PT USED NEW METER. THE FIRST READING AT 9:35 PM WAS 352. THE SECOND READING AT 9:45 PM WAS 571. PT TOOK 6 UNITS OF REGULAR INSULIN, THE APPROPRIATE DOSE AND TYPE FOR THESE UNUSUALLY HIGH READINGS. PT IMMEDIATELY RETURNED HOME AND RECHECKED BLOOD SUGAR AT 9:58 PM WITH OLD METER. THIS THIRD READING WAS 180. PT DRANK A LOT OF JUICE TO COUNTERACT THE INSULIN AND WAS DRIVEN TO THE HOSP TO USE ONE OF THEIR MACHINES. FOURTH READING WAS 140. AFTER PT RETURNED HOME, PT MONITORED SUGAR LEVELS. LAST READINGS AT 12:53 AM WAS 152.
PT UNDERWENT A THORACENTESIS DUE TO A LARGE RIGHT PLEURAL EFFUSION. UPON WITHDRAWAL OF THE THORACENTESIS NEEDLE, A PORTION OF THE CATHETER REMAINED INSIDE THE RIGHT CHEST. THIS THEN STINTED THE HOLE OPEN WHICH ALLOWED FOR AIR TO BECOME A SUB-PNEUMONIC PNEUMOTHORAX ON THE RIGHT. THE PORTION OF THE CATHETER WAS SUCCESSFULLY REMOVED AT A LATER DATE.
PRIOR TO PROCEDURE CRNA TESTED MACHINE AND FOUND NO LEAKS OR OTHER PROBLEMS. FIVE MINS AFTER ANESTHETIC GAS INITIATED, THE PT BEGAN EMERGING FROM ANESTHESIA. CRNA ADMINISTERED IV AGENTS AND SWITCHED TO ANOTHER INHALED AGENT. A FEW MINS LATER THE PT AGAIN BEGAN EMERGING FROM ANESTHESIA. PT MAINTAINED WITH IV SEDATION DURING PRODUCT PROBLEM. NEW MACHINE HOOKED UP TO PT AND NO FURTHER PROBLEMS, AFTER EXTENSIVE BREAKDOWN OF EQUIPMENT, CORROSION FOUND IN AREAS NOT SUBJECT TO PREVENTATIVE MAINTENANCE. INHALATION VAPORIZERS PERFORMED CORRECTLY WHEN TESTED ON ANOTHER MACHINE. THE MFR'S TECHNIQUE EXAMINED THE MACHINE AND SPECULATED THAT THE CORRODED PARTS MAY HAVE CAUSED SMALL LEAKS.
IABP CATHETER WAS INSERTED BY PERCUTANEOUS FEMORAL APPROACH IN CARDIAC CATH LAB. BLOOD WAS NOTED IN SAFETY CHAMBER. CATHETER WAS REPLACED AND FOUND TO BE RUPTURED.
RPTR WITH INTACT, STILL IMPLANTED SILICONE BREAST IMPLANTS SUFFERS FROM THE FOLLOWING: HYPOTENSION, PERIPHERAL NEUROPATHY, BRAIN LESIONS, DEPRESSION, ANXIETY, SHORT TERM MEMORY LOSS, MS, IBS, PAIN, HAIR LOSS, HEADACHES, ALLERGIES, ARTHRALGIA, FIBROMYALGIA, RASHES, CHRONIC INSOMNIA, CHRONIC FATIGUE SYNDROME, SICCA AND CLUMSINESS.
NSG FORWARDED "BROKEN IV CASSETTE" USED IN ICU - STAFF NOTED FLUID DECREASE IN BOTTLE, THEN CHECKED CASSETTE IN ANOTHER PUMP. CASSETTE TESTED BY BIOMED. NO FLUID DELIVERED BY CASSETTE, ALTHOUGH PUMP WORKS. NO ALARMS TRIGGERED. PT HAD NO NEGATIVE EFFECT. NURSING STATES THIS IS 1ST TIME PROBLEM WITH THIS PRODUCT.
RPTR HAD BILATERAL BREAST IMPLANTATION ON 4/21/76 FOLLOWING MASTECTOMY FOR FIBROCYSTIC DISEASE. SHE HAS SUBSEQUENTLY SUFFERED THE FOLLOWING: HEMATOMA AND INFECTION OF THE RIGHT IMPLANT SITE; RUPTURED LEFT IMPLANT SECONDARY TO CAPSULAR CONTRACTURE AND NUMBNESS ON THE LEFT, CHRONIC UTI'S, LOW BP, PERIPHERAL NEUROPATHY, ANXIETY, LACK OF CONCENTRATION, SHORT TERM MEMORY LOSS, DIZZINESS, ATYPICAL MS, STROKE, PAIN, INFLAMMATION, ELEVATED CHOLESTEROL, EXTREMITY PAIN AND SWELLING, RAYNAUD'S DISEASE, CONSTIPATION, IBS, HYSTERECTOMY, HAIR LOSS, HEADACHES, CHF, ANGINA, ALLERGIES, LUPUS, RHEUMATOID ARTHRITIS, LUNG PROBLEMS, AXILLARY LYMPHADENOPATHY, FATIGUE, INSOMNIA AND FIBROMYALGIA. IMPLANT DATES: RIGHT 4/21/76, 11/17/76, LEFT: 4/21/76, RIGHT #1 9/21/76. EXPLANT DATES: RIGHT #2 AND LEFT 1/3/95.
ON 10/30/80 RPTR HAD A BILATERAL SUBCUTANEOUS MASTECTOMY BECAUSE OF SCLEROSING ADENOSIS (A PREMALIGNANT LESION). ON 11/21/80 RPTR HAD BREAST RECONSTRUCTION WITH DOUBLE LUMEN SILICONE IMPLANTS. RPTR HAD ALL KINDS OF PROBLEMS - SWELLING, DRAINING, MANY INFECTIONS WITH MANY ANTIBIOTICS. DRAINING NOTED IN THE SURGEON'S RECORDS WERE 50CC ON 12/1/80; 100CC ON 12/3/80 OF THIN, BROWNISH-RED FLUID WAS EASILY DRAINED FROM THE WOUND. TOWARDS THE END OF THE DRAINAGE IT APPEARED TO BE PERFECTLY CLEAR. THEREFORE, RPTR IS CONCERNED THAT THE PROSTHESIS MAY HAVE LEAKED OR HAVE BEEN PUNCTURED BY DR ENTERING THE WOUND WITH A HEMOSTAT (THIS IS FROM DR'S RECORD DATED 12/3/80). 12/17/81 MINIMAL AMOUNT, 1/8/81 MINIMAL DRAINAGE, 1/9/81 LESS THAN 3CC, 1/12/81 MINIMAL DRAINAGE, ETC. 1/5/81 RIGHT PROSTHESIS EXPOSED. REMOVED THROUGH WOUND IN DR'S OFFICE. 1/15/81 INFLATABLE PROSTHESIS PUT IN TO KEEP THE SPACE IN THE RIGHT BREAST SO THE FIRST PROSTHESIS CAN BE PUT BACK IN, THE ERODED HOLE TO BE CLOSED. 2/10/81 REPLACEMENT OF RIGHT BREAST PROSTHESIS. 2/24/81 INFECTION, DRAINAGE, PROSTHESIS REMOVED AGAIN. 2/27/81 ON LEFT BREAST, THAT HAD BEEN DOING VERY WELL EXCEPT FOR CLOSED CAPSULOTOMY, THE SKIN WORE AWAY AND ERODED SO LEFT PROSTHESIS REMOVED. 4/30/81 RPTR WANTED NO MORE INTERNAL IMPLANTS SO A 2ND BILATERAL MASTECTOMY WAS DONE. WHEN RPTR'S DISEASE IS ACTIVE SHE SLEEPS ABOUT 14 HRS A DAY. SHE HAD HIGH BLOOD PRESSURE (MEDICATION WAS HCTZ AND CORGARD. DR SAID IT WAS UNUSUAL TO TAKE A PERSON OFF OF HIGH BLOOD PRESSURE MEDS). SHE IS HAVING PROBLEMS WITH HER EYES BECAUSE HER VISION CONSTANTLY CHANGES AND SHE HAS 3 PAIRS OF GLASSES. HER OPHTHAMOLOGIST SAID TO WEAR THE GLASSES SHE CAN SEE WITH EACH DAY. SHE ALSO HAS SWELLING OF HANDS AND FEET, STIFFNESS IN HANDS IN MORNING, SPASTIC COLON, RAYNAUD'S DISEASE IN FEET, STRANGE PAIN IN SCALP, AND SKIN RASHES. WITH A FLARE-UP OF LUPUS SHE CAN HARDLY FUNCTION. SHE HOLDS ON TO THE WALLS, CANNOT GO OUT ALONE, CANNOT DRIVE OR GO TO DR ALONE, CANNOT FOLLOW A STORY ON TV, HER SPEECH IS SLURRED, HER MIND ONLY GOES 1/3 THE USUAL SPEED AND SHE SLEEPS MOST OF THE TIME. SHE FEELS AS IF SHE HAS A TERRIBLE FLU. SHE REQUESTED TO HAVE HER IMPLANTS WERE REMOVED TO WEAR A BRA AS EXTERNAL PROSTHESES. THE BROWN PAPER BAGS THAT THE IMPLANTS WERE IN BECAME OILY. SOMETHING GREY IN COLOR WAS GROWING INSIDE THE IMPLANT AND THERE WAS SOMETHING INSIDE THE IMPLANT THAT LOOKED AND FELT LIKE BIRD SEED. SHE GAVE THE IMPLANTS TO THE DR WHO GAVE THEM TO THE MFR. DR TOOK PICTURES TO SHOW WHAT WAS INSIDE. RPTR DOES NOT KNOW WHERE THE IMPLANTS ARE NOW.
PT WAS ADMITTED TO HOSP ER IN RESPIRATORY DISTRESS. PT WAS ALREADY ON A PORTABLE VOLUME VENTILATOR UPON PRESENTATION TO ER. WHEN REMOVED FROM VENTILATOR, DISTRESS ENSUED. WHEN RETURNED TO VENTILATOR, BY HOSP PERSONNEL WHO WERE NOT FAMILIAR WITH OPERATION OF UNIT PT WAS USING. UPON RECONNECTION TO HOSP UNIT, PT CONDITION IMPROVED. A LACK OF USER KNOWLEDGE OF THE UNIT THE PT WAS USING, IS THE PROBABLE CAUSE OF DISTRESS DURING USE. DEVICE EXAMINED BY MFR REP AND A DETERMINATION WAS MADE THAT THE INCIDENT WAS MOST LIKELY DUE TO A LACK OF USER KNOWLEDGE.
MAMMOGRAPHY COMPRESSION PADDLE  CRACKED WHILE PT'S BREAST WAS COMPRESSED IN UNIT. LEFT INNER ARM WAS BRUISED. MFR WAS CALLED AND MADE AWARE OF THE INCIDENT. NEWLY CONSTRUCTED PADDLE WAS BROUGHT IN TO REPLACE THE BROKEN PADDLE. PADDLE WAS MODIFIED WITH TWO METAL BANDS TO ADD STRENGTH.
WIRE USED TO ARCH OF AORTA WITH 8 FR SHEATH. POST PTCA CRITICAL LESION IMPROVED, BUT PROXIMAL LESION APPEARED SIGNIFICANTLY WORSE. A 4.0 ANTERIOR STENT WAS ADVANCED TO PROXIMAL LESION WITH STENT IN THE RIGHT OSTIUM OF RCA. STENT DEPLOYED USING 6 ATMOSPHERIC PRESSURE. THE BALLOON RUPTURED AND WOULD NOT HOLD PRESURE. STAFF UNABLE TO PULL BALLOON BACK INTO THE GUIDING WIRE. PT UNDERWENT EMERGENCY CABG.
PT IN PULMONARY EDEMA. INTUBATED ON VENTILATOR IN ICU. VENT SETTINGS SIMV 10, TV 700, ENHALE TV 770 FI02 45%. ACTURAL RESP RATE, WAS 10 NON-ASSISTING THE VENT. RESP TECH HEARD HEATER ALARM AND ENTERED PTS ROOM AND FOUND PT HAD EXTUBATED SELF, LOW INSIRATORY PRESSURE ALARM OF 10 CM H20 AND LOW EXHALED VOLUME OF 200 CM H20. ALARMS WERE BOTH SET, BUT DID NOT SOUND THE ALARM. PT'S INSPIRATORY EFFORT WHILE EXTUBATED AND LOW O2,SAO2 OF 60. PT REINTUBATED AND PLACED ON NEW VENT.
PT UNDERWENT ESOPHAGEAL DILATATION WITH DILATORS #36, #38, & #42 OVER A GUIDE UNDER FLUROSCOPY. THE PT RETURNED TO THE HOSP FIVE HRS AFTER DISCHARGE WITH COMPLAINTS OF SEVERE UPPER ABDOMINAL PAIN AND WAS DIAGNOSED WITH AN ESOPHAGEAL TEAR. THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER TREATMENT. NO APPARENT EQUIPMENT DYSFUNCTION.
DURING REMOVAL OF PERICARDIAL DRAIN, TIP SHEARED AND REMAINED IN PT'S CHEST. SURGERY WAS REQUIRED FOR REMOVAL OF TIP. THE CATHETER WAS PLACED ON 8/29 FOR THE PURPOSE OF DRAINING FLUID FROM THE PERICARDIAL SPACE. THE CATHETER WAS REMOVED ON 8/30/95 SINCE THE ECHO INDICATED THE FLUID HAD PROPERLY DRAINED. UPON REMOVAL A LITTLE RESISTANCE WAS FELT BUT IT WAS NOT THOUGHT TO BE UNUSUAL. THE PHYSICIAN WIGGLED THE CATHETER WHEN THE SLIGHT RESISTANCE WAS NOTED THEN PULLED. AT THIS TIME CATHETER GAVE WAY AND IT WAS THEN NOTED THAT THE CATHETER HAD SHEARED AND THE DRAIN PORTION REMAINED IN THE PT. A GUIDE WIRE WAS NOT USED DURING THE REMOVAL OF THE CATHETER. A CT WAS OBTAINED AND NOTED THE REMAINDER OF THE CATHETER WAS IN THE ORIGINAL PLACEMENT SITE. ON 9/1/95 THE PT UNDERWENT SURGERY FOR THE REMOVAL OF THE DRAIN. BOTH ENDS OF THE DEVICE ARE AVAILABLE FOR INSPECTION AND WILL BE RETURNED TO CO.
THE PT'S FALLOPIAN TUBES WERE FOUND TO BE LACERATED FOLLOWING PLACEMENT  OF FALLOPIAN RINGS. THE TUBES THEN HAD TO BE CAUTERIZED.
RN INSERTED A 8 FOLEY CATHETER IN A 48-DAY-OLD MALE IN PICU WITH PNEUMONIA. AFTER 6 HRS THERE WAS NO URINE OUTPUT. FOLEY WAS REPOSITIONED AND A LARGE BLOOD CLOT WAS NOTED. URETHRAL TEAR WAS ALSO NOTED. RN REMOVED THE CATHETER.
AUGMENTATION IN 1982. 1995: MAMMOGRAM, TEST WAS DIFFERENT FROM 1992; SHOWED EVIDENCE OF RUPTURED MATERIAL OUTSIDE THE CAPSULE OF THE RIGHT BREAST.
BREAST AUGMENTATION: 1979 IN 1995, PAIN IN THE RIGHT BREAST WAS REPORTED. 10/12/95: REMOVAL BILATERAL BREAST IMPLANTS.
ELDERLY RESIDENT WAS BEING LIFTED FROM THE BED TO A WHEELCHAIR WHEN THE LIFTER RELEASED AND DROPPED THE RESIDENT BACK DOWN TO THE BED.
PT FOUND ON FLOOR IN PT ROOM BESIDE BED, AFTER NURSE HEARD CALL FOR HELP. ALL 3 SIDE RAILS WERE UP. THE TOP SIDE RAIL ON THE RIGHT SIDE OF THE BED WAS DISCOVERED TO BE BENT OUT AFTER THE ACCIDENT.
PACEMAKER GENERATOR EXCISED AND THE LEAD WAS TESTED AND WAS FOUND TO HAVE EXIT BLOCK SO THE LEAD WAS CAPPED. NEW GENERATOR AND LEAD WERE PLACED. FAILED DEVICE PLACED 10 YEARS AGO.
LOOSENED HEMIARTHROPLASTY PROSTHESIS LEFT KNEE AND SYNOVITIS LEFT KNEE. OPERATIONS: REMOVAL OF HEMIARTHROPLASTY PROSTHESIS LEFT KNEE. SYNOVECTOMY ANTERIOR/POSTERIOR COMPARTMENT LEFT KNEE. REVISION TOTAL KNEE PLACEMENT.
REPLACEMENT OF POWER PACK IN RIGHT LOWER QUADRANT OF BACK DUE TO BATTERY OR POWER PACK FAILURE.
MALFUNCTIONING PORT REMOVED AND NEW ONE INSERTED. THE CATHETER WAS FOUND TO BE INTACT, BUT A NEEDLE HOLE IN THE CATHETER WAS LEAKING BELOW THE LEVEL OF WHERE A PORT IS USUALLY STUCK FOR USAGE. THIS IS THE 3RD UNIT PLACED IN THIS PT IN THE PAST YEAR.
AFTER CAST REMOVED FROM PT'S RIGHT LOWER EXTREMITY, A SMALL LACERATION WAS FOUND OVER 1ST METATARSAL OF RIGHT FOOT. OPERATOR STATED BLADE WAS DULL. DEFICIENCIES FOUND IN TRAINING, USER ERROR. EQUIPMENT CHECK SATISFACTORY. NO MALFUNCTION, BLADE REPLACED.
PT FOUND TO HAVE BLISTERS ON BUTTOCKS AND NEAR SACRAL AREA AFTER USING HEATING PAD. PT HAD REPORTEDLY BEEN INSTRUCTED NOT TO LIE ON HEATING PAD, BUT SAID SHE DID IT ALL THE TIME AT HOME. HEATING PAD STARTED 10/11/95 BLISTERS DISCOVERED 10/12/95. HEATING PAD DISCONTINUED AT THIS TIME.
PT DISCOVERED TO HAVE BLISTER ON LEFT INNER FOREARM. BLISTER BELIEVED TO HAVE BEEN CAUSED BY THE HEAT OF A HEATING PACK. INVESTIGATION REVEALED USER ERROR AND LACK OF TRAINING RELATED TO PERSON APPLYING PACK. INJURY HEALED PRIOR TO PT DISCHARGE FROM HOSP.
ON 7/21/95, DURING CORONARY ARTERY BYPASS SURGERY ON A 61-YR-OLD MALE PT, THE OXYGENATOR ON BYPASS MACHINE WAS NOT ADEQUATELY OXYGENATING BLOOD DURING THE REWARMING PHASE. THE DEVICE WAS RETURNED TO THE MFR FOR EVALUATION. THE TEST RESULTS DID NOT IDENTIFY THE SOURCE OF THE DIFFICULTY EXPERIENCED BUT THE QA AND MFG PERSONNEL WERE NOTIFIED.
ON 7/28/95 DURING CORONARY ARTERY BYPASS SURGERY ON A 75-YR-OLD MALE PT, THE PERFUSIONIST NOTED BLOOD FOAM WAS VENTING FROM THE EXHAUST PORT. THE DEVICE WAS EVALUATED BY THE MFR AND A FIBER LEAK WAS OBSERVED AT THE 6TH FIBER CHANNEL ON THE GAS INLET SIDE OF THE GAS MANIFOLD.
ON 9/13/95 NURSE NOTED BLOOD IN IABP LINE OF A 59-YR-OLD FEMALE PT WHO WAS STATUS POST CORONARY ARTERY BYPASS SURGERY. PT RETURNED TO THE OPERATING ROOM FOR REMOVAL AND REPLACEMENT OF IABP CATHETER. THE CATHETER WAS RETURNED TO THE MFR FOR EVALUATION. THE CONCLUSION WAS THAT THE DAMAGE NOTED IS CONSISTENT WITH THAT KNOWN TO OCCUR WHEN A BALLOON CATHETER IS USED IN THE PRESENCE OF INTRA-AORTIC PLAQUE.
A 59-YR-OLD FEMALE PT, STATUS POST CORONARY ARTERY BYPASS GRAFT SURGERY, RETURNED TO THE OPERATING ROOM 9/19/95 FOR RUPTURED IABP CATHETER TO BE REMOVED. SECOND EVENT FOR SAME PT. THE CATHETER WAS RETURNED TO MFR FOR EVALUATION. THE CONCLUSION WAS THAT THE DAMAGE NOTED IS CONSISTENT WITH THAT KNOWN TO OCCUR WHEN A BALLOON CATHETER IS USED IN THE PRESENCE OF INTRA-AORTIC PLAQUE.
ON 10/16/95 A INTRA-AORTIC BALLOON PUMP WAS INSERTED IN A 76-YR-OLD MALE PT AND THE "GAS LOSS" ALARMS REPEATED ALARMED. ON VISUAL INSPECTION, BLOOD WAS NOTED IN THE GAS LINE TUBING. THE CATHETER WAS REPLACED WITH A NEW ONE. THE CATHETER WAS EVALUATED BY THE MFR AND CONCLUDED THAT THE DAMAGE NOTED IS CONSISTENT WITH THAT KNOWN TO OCCUR WHEN A BALLOON CATHETER IS USED IN THE PRESENCE OF INTRA-AORTIC PLAQUE.
ON 10/17/95 THE INTRA-AORTIC BALLOON PUMP ALARMED. ON VISUAL INSPECTION, BLOOD WAS NOTED IN THE CATHETER TUBING OF A 76-YR-OLD MALE PT. THE BALLOON CATHETER WAS DISCONTINUED AND NOT REPLACED AS THE PT WAS STABLE. THIS WAS THE SECOND EVENT INVOLVING THIS PT. THE CATHETER WAS EVALUATED BY THE MFR. HOLES WERE FOUND CONSISTENT WITH ABRASION. THE CONCLUSION WAS THIS DAMAGE IS CONSISTENT WITH THAT KNOWN TO OCCUR WHEN A BALLOON CATHETER IS USED IN THE PRESENCE OF INTRA-AORTIC PLAQUE.
ON 4/10/96, COMPLAINANT'S NURSING HOME EXPERIENCED A MALFUNCTIONING BATTERY-OPERATED PT LIFT. THE LIFT APPARENTLY STOPPED DURING OPERATION. PT EXPERIENCED HEMATOMA OF RIGHT CHEST.
RPTR RECEIVED 24 HEMOSTATIC FORCEPS (CURVED) AND DISCOVERED BURRS ON 13 OF THESE. THE BURRS ARE ON THE LOCKBOX AND POSE A POSSIBILITY OF PUNCTURING THROUGH SURGICAL GLOVES WORN BY SURGEONS.
UPON OPENING A PACKAGE OF 3-0 COATED SUTURE, NINE SUTURES WERE FOUND INSTEAD OF THE CORRECT QUANTITY OF EIGHT SUTURES WITHIN A PACKAGE. DUE TO THE ACCOUNTABILITY OF THE NUMBER OF SUTURES USED ON A PT, THIS COULD POSE A POSSIBLE PROBLEM. ALL REMAINING STOCK OF SAME LOT NUMBER HAS BEEN CHECKED, AND FOUND TO BE ERROR FREE.
THE VALVE IN THE PILOT BALLOON STICKS WHEN THE CUFF IS INFLATED WITH A SYRINGE. WHEN THE SYRINGE IS REMOVED, THE STICKY VALVE CAUSES THE CUFF TO DEFLATE. THIS OCCURRED IN AT LEAST 5 INSTANCES IN THE LAST WEEK. RPTR HAS CURRENTLY REMOVED ALL TRACHS THIS SIZE FROM CIRCULATION.
THIS ITEM DOES NOT HAVE THE PROPER MEASUREMENTS TO GUIDE PLACEMENT FOR SUCTIONING. 6FR FEEDING TUBE.
CURRENT BULBS DO NOT PRODUCE SATISFACTORY SUCTION FOR SUCTIONING OUT NOSES AND MOUTHS ON NEWBORNS. ANOTHER MFR'S PRODUCT IS A MUCH MORE SATISFACTORY FOR NEWBORN SUCTIONING. SUCTIONING SECRETIONS IN NEWBORNS IS A VERY IMPORTANT PART OF THE RESUSCITATION AND IT IS IMPORTANT TO HAVE A PRODUCT THAT PRODUCES ENOUGH SUCTION TO DO THIS JOB.
CATARACT EXTRACTION LEFT EYE - WHILE FILLING THE ANTERIOR CHAMBER OF THE LEFT EYE, THE NEEDLE SHOT OFF THE SYRINGE INTO THE EYE. VITREOUS HEMORRHAGE AND RUPTURE OF POSTERIOR CAPSULE.
LINES ARE STICKING TOGETHER AND/OR KINKING.
CRNA WAS SETTING UP FOR A SURGICAL CASE ON 5/8/96. HE OPENED THE 20CC SYRINGE PACKAGE AND NOTICED SOMETHING DARK IN THE LUER LOCK CAP. HE REMOVED THE CAP AND NOTICED A DEAD INSECT INSIDE THE CAP. HE REPLACED THE CAP ON THE SYRINGE AND RETURNED THE SYRINGE TO ITS PACKAGE. HE GAVE THE ENTIRE SYRINGE/PACKAGE TO THE INFECTION CONTROL NURSE WHO FORWARDED IT TO THE PHARMACIST/MEDICAL DEVICE RECALL COORDINATOR.
PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) PLACED WITHOUT DIFFICULTY. UPON INITIATION OF NORMAL SALINE FLUSH PT COMPLAINED OF "FUNNY SMELL", SEVERE UPPER BACK PAIN AND FLUSHING OF NECK AND FACE. 25 MG IV BENADRYL GIVEN. ALL ADVERSE REACTIONS SUBSIDED WITHIN 5 MINS OF BENADRYL.
ROUTINE INSERTION OF MIDCLAVICULAR CATHETER PERFORMED BY RN. CATHETER INSERTED INTO LEFT CEPHALIC VEIN WITH RESISTANCE MET AFTER 5 INCHES OF INSERTION. CATHETER FLUSHED, SECOND ATTEMPT MADE TO ADVANCE CATHETER WITHOUT SUCCESS. LINE THEN REMOVED AND CATHETER NOTED TO BE INCOMPLETE. PT TRANSFERRED TO HOSP BY AMBULANCE AND UPON X-RAY, CATHETER FRAGMENT LOCATED IN A/C SPACE. SURGICAL REMOVAL PERFORMED IN ER WITH 5 INCHES OF CATHETER REMOVED FROM "TISSUE BELOW A/C."
ROUTINE INSERTION OF MIDCLAVICULAR CATHETER PERFORMED BY RN. RN INSERTED, THEN REMOVED LINE AFTER REALIZING SHE DID NOT FLUSH IT. UPON INSPECTION OF CATHETER SHE NOTICED THAT IT "APPEARED FUNNY" BUT THE ENTIRE LENGTH WAS REMOVED AND PRESENT WITH THE TIP BEVELED. THE RN SAVED THE CATHETER AND IT WAS RETURNED TO THE OFFICE. THE PRODUCT WAS GOING TO BE RETURNED TO THE MFR TO EXAMINE, BUT IN THE MEANTIME RPTR HAD ANOTHER PROBLEM WITH ONE OF THESE CATHETERS. AFTER THIS SECOND PROBLEM RPTR RE-EXAMINED THE CATHETER FOR THIS PT AND AFTER PLACING IT ON FLUORESCENT ORANGE PAPER AND USING A MAGNIFYING GLASS, NOTICED THAT A 3 1/2 CM PIECE OF CATHETER WAS MISSING FROM THE TIP. RPTR IMMEDIATELY NOTIFIED THE PHYSICIAN WHO SAW THE PT THAT DAY AND X-RAYED THE RIGHT ARM. CATHETER FRAGMENT FOUND ON X-RAY TO RIGHT AXILLARY VEIN. AT TIME OF THIS REPORT, CONSULTATIONS WERE IN PROGRESS TO DETERMINE BEST METHOD OF INTERVENTION AND PT WAS IN STABLE CONDITION.
#TWENTY CATHETER INSERTED IN RIGHT ANTECUBITAL FOSSA WITHOUT DIFFICULTY. CATHETER INSERTED 6 INCHES WITH NORMAL SALINE FLUSH. WITHIN 5 MINS AFTER INSERTION PT EXPERIENCED INCREASED HEART RATE (170 BPM), RAISED RASH ON ARMS AND LEGS AND BRONCHOSPASM. PT GIVEN BENADRYL IV AND EPINEPHRINE INHALER AND PLACED BACK ON VENTILATOR. CATHETER DISCONTINUED. ALL SYMPTOMS SUBSIDED WITHIN 10 MINS OF DISCONTINUING DEVICE.
TUBING LEAKED AT "SEALED" POINT WHERE TUBING CONNECTS TO THE LUER LOCK AT PT'S END LINE.
IMPLANTED HARDWARE BROKE IN PT WITH NON-UNION FRACTURE OF LEFT ANKLE.
A SECURE CONNECTION COULD NOT BE MAINTAINED ON THREE (3) PEDIATRIC TRACHEOSTOMY TUBES AND VARIOUS SWIVEL ADAPTORS. IT IS UNKNOWN HOW LONG THE DEVICES WERE IN PLACE WHEN THE DISCONNECTS WERE DETECTED. ON 3/29/96 TECH REP CONDUCTED SITE VISIT TO REVIEW FACILITY'S DEVICE USAGE AND TO DISCUSS RECOMMENDED DEVICE AND ANCILLARY RESPIRATORY CONNECTOR ATTACHMENT TECHNIQUES AND PROTOCOLS. THERE WERE TWO (2) PTS INVOLVED WITH NO REPORTED PT COMPROMISE. THE THREE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS AND INVESTIGATION.
DEATH OF A 6-YR-OLD VENTILATOR DEPENDENT PARAPLEGIC BOY DUE TO DISCONNECTION FROM VENTILATOR. REPORTEDLY PORTABLE VENTILATOR ALARMS DID NOT FUNCTION TO ALERT THE BOY'S FAMILY OF THE DISCONNECTION. RPTR CONTACTED DETECTIVE WHO STATED THAT HE INTENDED TO INVESTIGATE THE EVENT FROM THE PERSPECTIVES OF BOTH A DEVICE FAILURE AND A POSSIBLE CRIMINAL EVENT (EUTHENASIA). RPTR ALSO OBSERVED THE TESTING OF THE DEVICE, PERFORMED BY CLINICAL ENGINEER HIRED BY MFR AND WITH CONSENT OF THE POLICE DEPT. THIS TESTING WAS DONE IN THE PRESENCE OF THE DETECTIVE AND REP FROM THE MFR, THE HEALTH DEPT, AND THE VICTIM'S FATHER. THE RESULTS OF THIS TESTING (LASTING APPROX 4 HRS) FAILED TO REVEAL ANY DEFECTS IN THE DEVICE. CO ADMITTED THE RECOGNIZED POSSIBILITY OF RANDOM/INTERMITENT FAILURES IN THESE DEVICES. CO REP STATED THAT HE INTENDED TO PERFORM EXTENDED TESTING (CONTINUOUS MONITORING OF THE DEVICE'S OPERATIONS OVER A PERIOD OF DAYS) OF THE DEVICE AT MFR'S FACILITY. NEWSPAPER ARTICLES INDICATE THE TESTING FAILED TO REVEAL ANY DEVICE PROBLEMS. THE PD INTENDS TO CONTINUE TO INVESTIGATE THE EVENT FROM A CRIMINAL PERSPECTIVE.
THE DECEDENT IN THIS CASE WAS AN 83-YR-OLD WOMAN WITH ALZHEIMER'S DISEASE WHO WEIGHED 97 POUNDS AND WHO WAS RESTRAINED, TO PREVENT FALLING, WITH A MEDIUM-SIZE VEST RESTRAINT MADE BY THE CO. SHE EXHIBITED THE RISK FACTORS FOR RESTRAINT ASPHYXIATION: COGNITIVE AND PHYSICAL DISABILITY, DOCUMENTED RESTLESSNESS WHILE RESTRAINED, AND A RECENT HISTORY OF BEING FOUND SUSPENDED IN A RESTRAINT. PERSONS WHO DIE ARE FIRST SUSPENDED IN THE VEST. AS THEY STRUGGLE, THE VEST GATHERS AROUND THE UPPER THORAX, CONCENTRATING THE COMPRESSING PRESSURE ON THE CHEST. THE PERSON'S WEIGHT IS CONVEYED THROUGH THE THORAX-ENCIRCLING VEST TO PREVENT VENTILATORY EXPANSION OF THE CHEST WALL. THE VEST TYPICALLY CATCHES ON THE UNDERSIDE OF THE PROXIMAL UPPER ARMS, LIFTING THE ARMS SO THAT THE PERSON CANNOT USE THEM EFFECTIVELY. OTHER VIEWS SHOW THAT THIS PERSON'S LIFTED LEFT ELBOW JAMMED INTO THE BEDDING, PREVENTING THE ARM FROM FULLY EXTENDING UPWARD. SHE COULD NOT USE HER ARMS TO PULL HERSELF TO SAFETY OR TO REACH FOR THE CALL BUTTON, WHICH IS POSITIONED PROPERLY. THE PROMINENT VENOUS CONGESTION OF THE LEFT ARM DISTAL TO WHERE IT WAS COMPRESSED BY THE RESTRAINT SUGGESTS THAT ARTERIAL PERFUSION CONTINUED AFTER SHE WAS SUSPENDED. THIS PERSON WAS ALIVE AND CAPABLE OF SUFFERING AS SHE DIED. THE VEST LABEL IS LESS AMBIGUOUS IN STATING A RECOMMENDATION FOR CONTINUOUS RAILS INSTEAD OF SPLIT RAILS. IT DEPICTS FULL LENGTH BEDRAILS AND SAYS, "USE ONLY FULL COVERED SIDERAILS IN THE UP POSITION." RPTR BELIEVES THAT THERE IS NO THERAPEUTIC ADVANTAGE TO EMPLOYING SPLIT RAILS FOR PERSONS WHO ARE RESTRAINED IN BED AND THAT IT IS LESS THAN OPTIMALLY SAFE TO DO SO. THE SLOT BETWEEN SPLIT HEAD AND FOOT RAILS SHOULD BE OBSTRUCTED COMPLETELY. ONCE, THIS PERSON WAS OUTSIDE THE RAILS, SHE DROPPED DOWN THE SLOT BETWEEN THE RAILS SUCH THAT THE RAILS BLOCKED HER FROM BACKING UP ONTO THE MATTRESS TO SAFETY. THE RELATIONSHIP BETWEEN HTE SMALL SIZE OF THIS PT RELATIVE TO THE HEIGHT OF TEH BED AND THE HEIGHT OF THE SIDERAILS RELATIVE TO THE MATTRESS IS ALSO IMPORTANT. THE MATTRESS APPEARS TO BE QUITE THICK FOR THIS BED, THEREBY RAISING THE TOP OF THE MATTRESS NEARLY TO THE TOP OF THE BEDRAILS. THIS MAY HAVE FACILITATED THIS PERSON'S PASSAGE OVER THE VALLEY BETWEEN THE RAILS. IN ADDITION, THE MATTRESS MAY HAVE BEEN LOWERED INCOMPLETELY, JUDGING BY THE UPWARD ANGLES OF THE BEDSPRING SUPPORT-STRUTS. THIS BED HEIGHT MAY HAVE PREVENTED THIS PERSON'S WEIGHT FROM REACHING AND RESTING ON THE FLOOR AND RELIEVING THE PRESSURE OF THE VEST ON HER CHEST. NEARLY ALL CHARTS OF CASES OF RESTRAINT ASPHYXIATION THAT RPTR HAS REVIEWED SHOW THAT STAFF HAD FOUND THE PT ALIVE AND SITTING ON THE FLOOR AT THE SIDE OF THE BED WITH THE RESTRAINT WHITHIN THE MONTH PRECEDING THE DEATH. THIS KIND OF "WARNING EVENT" OCCURRED 2 WEEKS BEFORE THIS WOMAN'S DEATH. FAIL-SAFE MECHANISMS IN THE EVENT OF AN UNFORESEEN SUSPENSION MAY HAVE PREVENTED THIS DEATH. THERE WAS NO ELECTRIC WARNING ALARM TO SIGNAL THAT THE PT HAD SLID OUT OF POSITION. (*)
DURING PHACOEMULSIFICATION-SCULPTING PHASE, DR NOTED THAT THE PHACO HANDPIECE STOPPED WORKING. THE SCREEN OF THE UNIT INDICATED GROUND FAULT-PHACO HANDPIECE. DR NOTED AT THIS TIME THAT THE PHACO TIP HAD CRACKED. A NEW PHACO HANDPIECE AND A FRESH PHACO TIP WAS THEN USED TO FINISH PHACOEMULSIFICATION. VISUAL INSPECTION OF THE PT'S EYE THROUGH THE MICROSCOPE DID NOT REVEAL ANY METALLIC FRAGMENTS FLOATING IN THE ANTERIOR CHAMBER OF PT'S EYE PER THE DR. RUPTURE OF THE POSTERIOR CAPSULE OF PT'S RIGHT EYE HAPPENED AS A RESULT OF TIP CRACKING.
MULTIPLE LOT NUMBERS RECEIVED WITH PACKAGING PROBLEMS WHICH MAY EFFECT THE STERILITY OF THE PRODUCT. THE STERILE WRAPPER DOES NOT REMOVE PROPERLY CAUSING IT TO TEAR IN AN IRREGULAR MANNER. CO'S RESPONSE TO THE PROBLEM WAS THAT IT IS THE SEALING DEVICE MAKING TOO TIGHT OF A SEAL.
THE TIP OF AN EPIDURAL CATHETER REMAINED IN THE PT FOLLOWING SURGERY FOR BLADDER CANCER. THE PT IS ASYMPTOMATIC.
PHYSICIAN WAS REMOVING BONE WITH 4MM KERISON PUNCH, WHEN FOOT PLATE OF THE PUNCH BROKE OFF. PHYSICIAN RETRIEVED THE FOOT PLATE FROM THE PT.
LITHOTRIPTOR MALFUNCTIONED WHILE IN PT'S BLADDER AND REQUIRED CYSTOTOMY FOR REMOVAL OF INSTRUMENT AND BLADDER REPAIR.
COHB, THB, O2HB. THIS PROBLEM WAS KNOWN TO EXIST BY MFR OF BLOOD GAS EQUIP AND BLOOD GAS SYRINGES, BUT WAS NOT REPORTED UNTIL RPTR CALLED TO QUESTION DATA.
INADEQUATELY FUNCTIONING CATHETER REMOVED. POST-OP, DEVICE CLEANED AND FOUND TO HAVE A SLIT IN THE CATHETER.
A NEURO CERVICAL SPINE PLATE WHICH WAS IMPLANTED ON 9/19/95 CRACKED AND WAS REMOVED ON 4/9/96.
SILICONE IMPLANTS REPLACED 6 OR 7 TIMES. TOTAL NUMBER OF RESULTING BREAST SURGERIES BEGINNING WITH FIRST IMPLANT SURGERY IS 13. FOLLOWING MASTECTOMY FOR FIBROCYSTIC DESEASE. RPTR HAS 1 SON AGE 15 DIAGNOSED WITH LUPUS AND CONNECTIVE DISSUE DISEASE. WAS IN COMA AT AGE 1 1/2 YRS. DIAGNOSED WITH IMMUNE SYSTEM SHUT DOWN. RPTR COMPLAINS OF: CHRONIC INFECTIONS, BLOOD PRESSURE PROBLEMS, CARPAL TUNNEL SYNDROME, BRAIN LESIONS, ANXIETY AND/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, DEMENTIA, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, BASAL CARCINOMAS, PAIN INFLAMMATION OF THE CHEST, ELEVATED CHOLESTEROL, TRIGLYCERIDES, NOW LIGALLY BLIND, EXTREMITY SWELLING, PAIN, CHRONIC DISCOLORATION, RAYNAUD'S DISEASE, FREQUENT LOW GRADE FEVER, DIARRHEA, GASTRITIS, REMOVAL OF GALL BLADDER UPCOMING SOON - 1996. OVARIAN PROBLEMS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, ANGINA, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, LUPUS, SJOGREN'S SYNDROME, JOINT INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS, MUSCLE PAIN AND BURNING, FIBROMYALGIA, UNEXPLAINED RASHES, SUN SENSITIVE, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICANOMAS, CLUMSINESS, MISJUDGING DISTANCE, RUNNING INTO OBJECTS AND SICCA.
RPTR COMPLAINS OF: ANXIETY, DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, GETTING LOST OR CONFUSED, CHEST PAIN AND INFLAMMATION, THYROID PROBLEMS, EXTREMITY SWELLING, PAIN, DISCOLORATION, HEAT AND COLD SENSITIVE, FREQUENT LOW GRADE FEVER, LOWERED BODY TEMP, CHRONIC DIARRHEA, CONSTIPATION, ESOPHAGITIS, DUODENITIS, GASTRITIS, IRRITABLE BOWEL SYNDROME, CLOTS IN UTERUS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, FREQUENT MIGRAINES, SEVERE HEADACHES, HYPERSENSITIVITY TO CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, SJOGREN'S SYNDROME, JOINT INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARHTHRITIS, PERSISTENT JOINT STIFFNESS, VOMITING BILE, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS, CHRONIC UNEXPLAINED MUSCLE SPASMS, MUSCLE PAIN AND BURNING, MUSCLE ATROPHY, FIBROMYALGIA, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, DERMATOMYOSITIS, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, MISJUDGES DISTANCE/RUNS INTO OBJECTS. (*)
RPTR COMPLAINS OF: ANXIETY, DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, GETTING LOST OR CONFUSED, CHEST PAIN BURNING SENSATION, INFLAMMATION, THYROID PROBLEMS, EXTREMITY CHRONIC SWELLING, CHRONIC PAIN, CHRONIC DISCOLORATION, HEAT AND COLD SENSITIVE, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA, CONSTIPATION, ESOPHAGITIS, DUODENITIS, GASTRITIS, IRRITABLE BOWEL SYNDROME, CLOTS IN UTERUS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, FREQUENT MIGRAINES/SEVERE HEADACHES, HYPERSENSITIVITY TO CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, SJOGREN'S SYNDROME, JOINT INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARHTHRITIS, PERSISTENT JOINT STIFFNESS, VOMITING BILE, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY UNDER ARMS, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN AND BURNING, MUSCLE ATROPHY, FIBROMYALGIA, UNEXPLAINED RASHES, SUN SENSITIVE, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, DERMATOMYOSITIS, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, CLUMSINESS, MISJUDGING DISTANCE/RUNNING INTO OBJECTS.
A 91-YR-OLD, 76 POUND FEMALE RESIDENT WAS FOUND ON THE FLOOR BESIDE HER BED, LYING ON HER RIGHT SIDE. SHE SUSTAINED AN ABRASION TO HER MID CHEST AREA AND INJURED HER LEFT LEG WHICH WAS LATER DIAGNOSED AS A FRACTURE OF THE LEFT FEMUR. ALL FOUR SIDERAILS WERE UP WHEN THE RESIDENT WAS DISCOVERED BY THE CNA, SO IT IS BELIEVED THAT SHE MAY HAVE CAUGHT HER LEG IN THE LOWER SIDERAIL BEFORE SLIPPING BETWEEN THE RAILS TO THE FLOOR. THE RESIDENT WAS INCONTINENT OF A LARGE AMOUNT OF LOOSE STOOL AND ON A PLASTIC DISPOSABLE PAD WHICH MAY HAVE HELPED FACILITATE THE FALL. SHE COULD GIVE NO INFO AS TO HOW THE INJURY OCCURRED.
THIS IS THE SECOND KNOWN INCIDENT OF QUALITY CONTROL FROM MFR, SEE W.O.10761. OPERATOR SAID THAT UNIT NOT WORKING PROPERLY. OPERATOR BELIEVES THAT TEST MAY HAVE BEEN RUN WITH A BAD TUBE. DIRECTOR OF CARDIOLOGY FOUND A BAD TEST TUBE IN LOT OF TUBES THAT WAS REMAINING. CO'S DISTRIBUTORS SAID THAT FLAT TUBE SHOULD NOT AFFECT ANY READINGS. IN SPEAKING WITH THE ACTUAL CO REPS THEY SAID THIS COULD AFFECT PERFORMANCE. ONE PROBLEM THIS PRESENTS IS THAT PT'S BLOOD LEVEL CAN BE AFFECTED SINCE ABOUT 20CC OF BLOOD IS TAKEN FOR EACH TEST AND IF REPEAT TESTS ARE NECESSARY DUE TO BAD TUBES, THEN PT CARE CAN BE COMPROMISED. OPERATOR SAID THAT UNIT NOT WORKING PROPERLY. UNIT GIVING REAL SHORT ACT VALUES. PERFORMED CALIBRATION VERIFICATION PROCEDURE. FOUND THAT TEST TUBE MAY HAVE A PROBLEM WITH QUALITY CONTROL. FOUND FROM MFR THAT THE FLAT TUBES ARE NOT USED FOR ACT TESTS, AND NORMALLY HAVE WHITE TOP. WILL RETURN SAMPLE TO MFR AND THEY WILL SEND ANOTHER BOX OF TUBES. WILL ALSO MAKE ARRANGEMENTS FOR FINDING OTHER DEFECTIVE BATCHES OF TUBES.
WAS ADMIXING INTO 3ML MIXING CONTAINER (TPN) WHEN ADMIX SITE (PORT) FELL OFF CAUSING FLUID TO SPILL IN HOME (FLUID WAS TPN 3000ML TOTAL VOLUME).
YAG LASER SET UP AND CALIBRATED ACCORDING TO POLICY. AIMING BEAM CHECKED AND APPROPRIATE. LASER FIBER INSERTED IN THROUGH ENDOSCOPE. AIMING BEAM WORKED, THEN CUT OUT. OUTPUT FROM LASER DROPPED AFTER MALFUNCTION. NO APPARENT INJURY TO PT.
TPN BAG LEAKED, SEAM OF BAG BLEW OUT. TPN REPLACED.
RPTR HAS BREAST IMPLANTS SINCE 1990. SINCE THAT TIME, RPTR HAS HAD CONTINUED NECK AND SHOULDER PAIN, HEADACHES, AND RIGHT ARM PAIN. HAS HAD PHYSICAL THERAPY AND HAS CONSULTED WITH AN INTERNIST, A PSYCHIATRIST, AND A NEUROLOGIST. THESE PHYSICIANS COULD NOT CONFIRM IF SYMPTOMS WERE ASSOCIATED WITH HER IMPLANTS. HAS NOT GONE BACK TO THE PLASTIC SURGEON WHO PUT IN IMPLANTS TO CONSULT WITH HIM. HAS GATHERED INFO ABOUT SILICONE IMPLANTS AND FEELS THAT SHE IS STUCK BETWEEN A ROCK AND A HARD PLACE AND WOULD LIKE FURTHER INFO IF IT IS AVAILABLE.
STENT PLACED IN RCA BUT NOT DEPLOYED OR RETRIEVED FROM BODY. AT THIS POINT NO FURTHER COMPLICATIONS NOTED. PT WILL RETURN NEXT MONTH FOR ANOTHER PTCA.
RN PLACED CATHETER IN PT FOR LONGTERM ANTIBIOTIC THERAPY. WHILE FLUSHING WITH SALINE AND IMMEDIATELY AFTER INSERTION, PT COMPLAINED OF NAUSEA, SEVERE CHEST AND BACK PAIN, FOLLOWED BY FACE AND NECK FLUSHING. PREVIOUSLY NORMAL TEMP ROSE TO 101 DEGREES F. PT BECAME TACHYCARDIC WITH RIGOR AND INCREASED RESPIRATORY RATE UP TO 30 B/MIN. PT WAS TREATED WITH IV DEMEROL AND BENADRYL AND THE CATHETER WAS DISCONTINUED. SYMPTOMS SUBSIDED GRADUALLY OVER 1 HR AFTER CATHETER REMOVAL. CBC WAS DRAWN. AN EKG AND A CXR WAS DONE AND BOTH WERE WNL. PT WAS ALREADY IN A STEP-DOWN UNIT WHERE THE MD WAS IMMEDIATELY ON HAND. THE RPTR INFORMED THE MFR OF THE INCIDENT AND WAS ASKED IF THE SALINE USED HAD ANY PRESERVATIVES THAT THE PT MAY HAVE REACTED TO. RPTR RESEARCHED IT WITH HOSP PHARMACY AND FOUND THAT BENZYL ALCOHOL WAS PRESENT IN THE SALINE BUT ALLERGIC REACTIONS TO THIS AGENT ARE DIFFERENT THAN THE SYMPTOMS EXHIBITED BY HER PT. THE RESEARCH INFO ON BENZYL ALCOHOL REACTIONS WAS OBTAINED THROUGH THE RESEARCH DIVISION AT HER FACILITY. THE DEVICE WAS DISCARDED.
RPTR EXPERIENCED ASTHMA, RESPIRATORY AND STOMACH PROBLEMS.
ON 4/5/96 CATHETER HAD ONLY THE INTRODUCER AND SIDE PORT IN. NURSE ATTEMPTED TO DRAW BLOOD. AROUND THIS TIME THE PT BECAME UNRESPONSIVE AND IN RESPIRATORY DISTRESS AND OXYGEN SAT'S DECREASED. HE WAS INTUBATED AND TRANSFERRED TO CRITICAL CARE, CT SHOWED BILATERAL AIR EMBOLI TO BRAIN. ETIOLOGY NOT PROVEN, BUT PROBABILITY OF LINE IS CONSIDERED. PT EXPIRED 4/12/96, NO AUTOPSY.
SUPRAPUBIC FOLEY CATHETER INSERTED. 4 WKS LATER, ATTEMPTS TO REMOVE CATHETER UNSUCCESSFUL AS BALLOON WOULD NOT DEFLATE. PT TAKEN TO OR WHERE CYSTOSCOPY WAS PERFORMED TO DEFLATE AND REMOVE CATHETER.
NURSE TECH RECEIVED MILD ELECTRICAL SHOCK WHEN PLUGGING IN AUTOMATIC BP MACHINE; RECEIVED SUBSTANTIAL SHOCK WHEN SHE UNPLUGGED MACHINE. SUSTAINED BURNS TO HER RIGHT THUMB, HAD PAIN RADIATING TO ARM AND SHOULDER. WAS SEEN IN EMPLOYEE HEALTH. DEVICE CHECKED BY ENGINEERING DEPT. FRAYED CORD REPLACED. NO OTHER PROBLEMS WITH DEVICE.
SUTURE AT SKIN WAS CUT, GENTLE TRACTION APPLIED TO DRAIN TUBING. TUBING SPONTANEOUSLY FRACTURED PROXIMAL TO END. PT RETURNED TO SURGERY FOR REMOVAL OF RETAINED DRAIN. (*)
PT HAD PENETRATING KERATOPLASTY, ANTERIOR VITRECTOMY WITH INTRAOCULAR LENS EXCHANGE 1/7/93. PT PRESENTS WITH INCREASED INTRAOCULAR PRESSURE AND PSEUDOPHAKIC BULLOUS KERATOPATHY.
UNIT WOULD NOT COMMUNICATE WITH PROGRAMMERS. DIAGNOSED AS A DIELECTRIC FAILURE. SURGICAL REPLACEMENT NECESSARY.
BONE MARROW BIOPSY NEEDLE BROKE ON REMOVAL FROM BONE.
NEW ONSET ACUTE MITRAL REGURG. NONE PRESENT 4/22/96 BY PHYSICAL OR ECHO. HAS BOVINE HEART VALVE IMPLANTED 11/25/81. 5/10 TRANSESPHOHAGEAL ECHO SHOWS APPARENT LEAFLET DISRUPTION. 5/14 MVR REDO, FOR LEAFLET DISRUPTION.
CONTRACTURE AND PAIN, STATUS POST SUBCUTANEOUS MASTECTOMIES AND BILATERAL SUBMUSCULAR IMPLANTS. REMOVAL OF IMPLANTS, OPEN CAPSULOTOMY, BILATERAL TRAM FLAP RECONSTRUCTION OF BREAST. RELEASE OF SCAR CONTRACTURE OF RIGHT AXILLA WITH Z PLASTY.
PT HAD SURGICAL PRCEDURE PERFORMED ON 3/14/96 TO REMOVE A RUPTURED SILICONE BREAST IMPLANT.
BALLOON ON STENT FAILED TO INFLATE WHEN TRIED THREE DIFFERENT TIMES. THE CATHETER WAS PULLED OUT AND STENT WAS NO LONGER ON BALLOON.
PT PRESENTED WITH PAIN. PATELLAR BUTTON AND INSERT SHOWED WEAR. BOTH WERE REMOVED AND REPLACED. NORMAL WEAR AND POSSIBLE MALALIGNED TIBIAL COMPONENT MAY HAVE CAUSED WEAR.
PT LEGS FOUND TO HAVE EDEMA (RIDGE) AT TOP OF STOCKINGS WRAP. HEMATOMA OVER FRONT OF LEG IN LINE WITH TOP OF WRAP. CIRCULATION CHECKS WITHIN NORMAL LIMITS. PT ON ORAL AGENT FOR DIABETES AND SQ HEPARIN POST-OPERATIVE.
DURING OP SURGICAL PROCEDURE, MULTIPARAMETER MONITORING MACHINE FROZE UP. WAS INCAPABLE OF MONITORING THE PT DURING SURGERY. BIOMED CALLED STAT FOR MONITOR REPLACEMENT. NO INJURY TO PT. MONITOR REMOVED FROM INVENTORY AND MFR CONTACTED. BIOMEDICAL ENGINEERING STATEMENT SUGGESTS ASSOCIATION WITH MONITOR FAILURE TO THE FIRING OF ELECTRO SURGICAL UNIT (ESU) WHICH WAS USED IN SURGICAL PROCEDURE.
PT INHALED SMALL PORTION OF PLASTIC CONNECTOR FROM MACHINE TUBING. PT EXPERIENCED CHOKING AND COUGHED UP SMALL PLASTIC MALE TIP FROM ORAL MODULE CONNECTION. FOUND TIP BROKEN ON BOTH TUBING CONNECTIONS.
SUPERVISOR TRANSPORTING SHARPS CONTAINER FOR DISPOSAL IN BIOHAZARD BOX. NEEDLE PROTRUDING THROUGH SHARPS CONTAINER CAUSED NEEDLE STICK.
BALLOON DEFLATED WHILE IN PT. NO MANIPULATION BY ANYONE TO CAUSE PROBLEM.
DR WAS REMOVING GUIDE WIRE FROM THE CATHETER AND WIRE UNCOILED.
PT HAD PICC IN LEFT ARM, PLACED IN LEFT CEPHALIC ANTECUBITAL VEIN. DURING CURRENT HOSPITALIZATION FOR PNEUMONIA, A CCU NURSE NOTED CHANGES IN LEFT UPPER ARM, NOTABLY A 2 INCH INCREASE IN CIRCUMFERENCE, MOTTLING, BLUISH COLORATION AND COOLNESS. NO EVIDENCE OF LINE INFECTION FOUND. IN VIEW OF ULTRASOUND REPORT SHOWING LARGE CLOTS, THE PICC WAS REMOVED. 4 DAYS LATER THE ARM IS STILL SWOLLEN. DUPLEX DOPPLER ULTRASOUND OF VEINS OF BOTH UPPER EXTREMITIES, 3/22/96. THE EXAMINATION WAS DONE ON A PORTABLE BASIS AND IS THEREFORE VERY LIMITED. IMAGING OF THE BRACHIAL, AXILLARY, AND LEFT SUBCLAVIAN, AS WELL AS LEFT JUGULAR VEIN, DEMONSTRATES THROMBOSIS. THE RIGHT DEEP VENOUS SYSTEM IS WIDELY PATENT, WITH NO EVIDENCE OF CLOT OR OTHER FLOW ABNORMALITIES. IMPRESSION: THROMBOSIS OF THE LEFT-SIDED VENOUS DRAINAGE OF THE LEFT UPPER EXTREMITY, INCLUDING THE LEFT JUGULAR VEIN, AS DESCRIBED. THE RIGHT DEEP VENOUS SYSTEM IS PATENT.
PT WAS CONNECTED TO FUNCTIONAL MONITOR, DEFIBRILLATOR, EXTERNAL PACEMAKER. EXTERNAL PACER PADS WERE APPLIED AND THE UNIT WAS SET AT A RATE OF 100/MIN AND AT 80 JOULES. PT EXPERIENCED GENERALIZED DISCOMFORT AND THE UNIT WAS DISCONNECTED. WHEN PACER PADS WERE REMOVED THREE SMALL BURNS WERE IDENTIFIED ON THE ANTERIOR CHEST WALL, UNDER THE PAD. 1) QUARTER SIZE, 1) DIME SIZE, 1) SMALLER THAN DIME SIZE.
CATHETER PLACED - UNABLE TO OBTAIN CORE TEMPERATURE. UPON EXAMINATION, 1 OF 4 WIRES FOUND MISSING FROM THERMISTOR PORT. CATHETER REMOVED. NEW CATHETER OBTAINED AND PLACED. PACKAGING DISCARDED.
HOSP HAS BEEN EXPERIENCING SOME PROBLEMS WITH THE INTERNAL STAPLERS. CO REPS HAVE BEEN VERY HELPFUL BY ASSISTING OPERATING ROOM STAFF TO IDENTIFY THE SOURCE(S) OF THE PROBLEMS AND ARRANGING FOR EVALUATION OF THE PRODUCTS. MALFUNCTIONS OF THE STAPLER HAVE RANGED FROM FAILURE TO FIRE TO INADEQUATE CLOSURE/STAPLING OF THE TISSUE. THE PROBLEMS OCCURRED AT THE END OF LAST YEAR AND HOSP HAS NOT EXPERIENCED ANY OTHER MALFUNCTIONS SINCE 12/95. HOWEVER, HOSP RECENTLY HAD THREE (3) CASES WHERE THE STAPLER APPARENTLY MALFUNCTIONED. REVIEW OF THE INCIDENTS REVEALS THAT THERE REALLY WERE NO COMMON FACTORS: TWO DIFFERENT SURGEONS WERE INVOLVED AND THE LOT NUMBERS OF THE STAPLERS IN QUESTION WERE DIFFERENT. HOSP IS VERY CONCERNED OVER THE ADD'L RISKS IMPOSED ON THE PT BY USING EQUIPMENT WHICH DOES NOT CONSISTENTLY PERFORM TO PROPER SPECS. HOSP HAS, THEREFORE, DECIDED TO TEMPORARILY DISCONTINUE USE OF THIS STAPLER UNTIL RECEIVING SUFFICIENT REASSURANCE FROM MFR THAT THIS PRODUCT IS SAFE FOR PTS.
EXTREME DIFFICULTY REMOVING PICC GUIDE WIRE. PICC INSERTED RIGHT MEDIAL CEPHALIC VEIN TO SVC. UNABLE TO REMOVE GUIDE WIRE. PT SENT TO X-RAY WITH WIRE IN PLACE. REMOVED 1 1/2 HRS LATER WITH HELP. WHITE GRIP AT END OF WIRE ALSO SLIPPED OFF DURING EFFORT. THIS REPORT REPRESENTS TWO PROBLEMS ENCOUNTERED WITH THIS DEVICE (GUIDE WIRE DIFFICULTY, HUB SLIPPING OFF). ADDITIONALLY, THIS OCCURRENCE IS ONE OF SEVERAL SIMILAR PROBLEMS. HOSP HAS EXPERIENCED WITH THIS CO'S PRODUCTS.
THE UNIT WAS MAINTAINED ACCORDING TO INSTRUCTIONS FROM THE CO. THE UNIT WAS NEVER USED ON A PT FOR DEFIBRILLATION; OCCASIONALLY IT HAD BEEN USED FOR BEDSIDE CARDIAC RHYTHM MONITORING OR FOR INSTRUCTION PURPOSES DURING PRACTIVE "CODE BLUE" SESSIONS WITH STAFF. THE UNIT WAS NEVER DROPPED OR DAMAGED IN ANY WAY. IN 1993 OR 1994 THE CO ISSUED A RECALL FOR THIS PARTICULAR UNIT. THEY SENT A TECH TO THE OFFICE TO REPAIR THE UNIT. RPTR WAS PRESENT AT THE TIME OF THE REPAIR AND SAW THAT THE TECHN REPLACED A SMALL DIODE? CAPACITOR? INSIDE THE UNIT. RPTR WAS THEN ASSURED THAT THE REPAIR WAS COMPLETE, AND THAT THE UNIT WAS RELIABLE. (RPTR HAD HAD NO PROBLEMS WITH THE UNIT BEFORE THE RECALL). OFFICE NURSE WAS DOING THE MONTHLY CHECK ON THE UNIT, CHARGING IT UP THEN DISCHARGING THE CURRENT THRU THE DEFIBRILLATOR PADDLES ONTO THE GROUNDED TERMINALS. AS HE DID THIS, THERE WAS AN EXPLOSION, WHICH BLEW OUT THE BOTTOM OF THE DEFIBRILLATOR CASE. HE WAS NOT INJURED. THIS OCCURRED ON 2/17/96.
PT'S HEART RATE BEGAN TO BRADY DOWN TO 47-48 PER MIN WITH 1ST DEGREE BLOCK. CARDIAC RHYTHM BECAME AGONAL AND PT WENT INTO CARDIAC ARREST. WHEN REGISTERED NURSE MANAGED DEFIBRILLATOR, SHE ATTACHED THE EXTERNAL PADDLES TO THE ADAPTOR THAT WAS NOT ATTACHED TO THE MACHINE. PREVIOUS MALFUNCTIONS OF THIS DEVICE RELATED TO USER ERRORS, RELATED TO IMPROPER CONNECTION OF ADAPTORS AND CABLES.
PT SCHEDULED FOR BILATERAL TUBAL OCCLUSION WITH FALLOPIAN RING. DURING SURGERY THE FALLOPIAN RING APPLICATOR FRACTURED THE TUBE AND CAUTERIZATION WAS REQUIRED FOR BLEEDING.
EVACUATED COLLECTION NEEDLES WOULD LEAK DURING BLOOD DRAW FROM PT CREATING ADD'L BLOOD LOSS AND POSSIBLE EMPLOYEE EXPOSURE TO BLOODBORNE PATHOGENS. APPROX BLOOD LOSS 1CC TO 5CC OF BLOOD FLOWING FROM PT'S ARM TO CHAIR/BED OR FLOOR DURING PROCEDURE. DEFECTIVE MEDICAL DEVICE NOT USED. ITEM REMOVED FROM USE TO PREVENT POSSIBLE EXPOSURE TO EMPLOYEES IN DEPT. PURCHASING DEPT WILL NOT REORDER ITEMS AND DIFFERENT ITEM WILL BE PROVIDED TO LAB DEPT TECHS.
PUMP DID NOT DELIVER THE PRESCRIBED VOLUME.
VITAL SIGNS, INC. 20 CAMPUS RD, TOTOWA, NJ 07512. OF THE 22,000 ELBOW'S MOLDED DURING THIS LOT CONTROL RUN, ONLY ONE HAS EXHIBITED THIS CONDITION. THIS CONCLUSION WAS DRAWN FROM THE RESULTS OF INSPECTIONS PERFORMED ON STATISTICALLY SIGNIFICANT LARGE QUANTITIES OF COMPONENTS FROM THIS ACTUAL LOT CONTROL NUMBER AT A SAMPLE INSPECTION LEVEL OF C=O, AQL=0.10%.
AN 81 YEAR OLD MALE COLLAPSED WHILE CLIMBING STEPS AT THE HOME OF A NEIGHBOR. AMBULANCE WAS CALLED WHEN COMPLAINED OF TROUBLE BREATHING. WHEN CREW ARRIVED, PT WAS WITHOUT PULSE. THERE HAD BEEN NO CPR PRIOR TO AMBULANCE ARRIVAL. DEFIBRILLATION WAS DONE WITH NO RESPONSE. PT WAS INTUBATED AND BAGGED, BUT THE EXHALATION VALVE ON THE AMBU-BAG WAS BLOCKED BY THE FILTER. PT WAS EXTUBATED AND RE-INTUBATED TWICE BEFORE THE PROBLEM WAS DETECTED. PT WENT INTO ASYSTOLE AND WAS STILL IN ASYSTOLE UPON ARRIVAL AT ER.
ADMITTED WITH 3 YR HISTORY OF AORTIC STENOSIS WITH PROGRESSIVELY WORSENING SHORTNESS OF BREATH. PRE-OPERATIVE STUDIES SHOWED ENLARGED LEFT ATRIUM AND LEFT VENTRICULAR HYPERTROPHY. TO OR ON 4/11/96 FOR REPLACEMENT OF AORTIC VALVE WITH MECHANICAL PROSTHESIS AND VALVE. POST OPERATIVELY HAD POOR RIGHT VENTRICULAR FUNCTION AND SEVERE CARDIAC DYSRHYTHMIA. SUGGESTED INFEROPOSTERIOR AND RIGHT VENTRICULAR MYOCARDIAL INFARCTION. PT DIED ON 4/13/96 OF MASSIVE MYOCARDIAL INFARCTION. CAUSE THOUGHT TO BE USER ERROR OR MIGRATION OR INTRA-OPERATIVE DISPLACEMENT OF SUTURED VALVE BY INTRA-OPERATIVE LEFT ATRIUM CATHETER INSERTION.
DR REPORTED THAT A WOUND DRESSING WAS IN PLACE IN AREA OF A THIRD MOLAR. PT DEVELOPED SORENESS AND WHAT SEEMED TO BE A SLIGHT INFECTION. DR INDICATED THAT INFECTION WAS POSSIBLY CAUSED FROM COMMUNICATION WITH THE SINUS. ANTIBIOTICS WERE GIVEN AND A DRAIN PLACED. DEVICE PLACED IN SITE OF TOOTH EXTRACTION.
A MANUAL RESUSCITATOR BAG WAS IN USE WHEN A POST-OPERATIVE PT DEVELOPED A TENSION PNEUMOTHORAX. THE SUSPECT BAG WAS EXCHANGED FOR ANOTHER BUT THE PT CONTINUED TO HAVE HYPOXEMIA, HYPOTENSION AND BRADYCARDIA. A NEEDLE THORACOSTOMY OF THE RIGHT CHEST FOLLOWED BY A CHEST TUBE INSERTED INTO THE RIGHT HEMITHORAX WAS STATED TO HAVE RESOLVED THE CARDIOPULMONARY SIGNS. THE BAG'S PEEP VALVE WAS NOTED TO HAVE COPIOUS SECRETIONS WITHIN IT. JOSTILING OF THE SPRING-LOADED VALVE RETURNED THE UNIT TO NORMAL FUNCTION.
INFECTION AT SITE OF MEMBRANE PLACEMENT. ANTIBIOTICS WERE USED FOR A TWO WEEK PERIOD. THE SITE IS HEALING WELL. DR STATED THAT THE INFECTION COULD HAVE BEEN CONTRIBUTED TO BY ANY OF THE PRODUCTS USED DURING THE PROCEDURE. TREATMENT WITH ANTIBIOTICS 3/8/96 THROUGH 3/22/96.
IN THE COURSE OF DEVELOPING ULTRASOUND FILMS IN ACCORDANCE WITH FACILITY INSTRUCTION AND DIRECTION, THE LEAD FILM DRAWER SUDDENLY AND UNEXPECTEDLY SLAMMED ON PLAINTIFF'S HAND. PLAINTIFF SUSTAINED INJURY TO HER LEFT HAND, IN THE FORM OF AN AMPUTATION OF A PORTION OF HER RING FINGER, PARALYSIS, IMPAIRMENT AND DISFIGUREMENT. THE FILM BIN ACCOMMODATES CARTONS OF X-RAY FILM FOR STORAGE IN A DARK ROOM TO PROTECT AGAINST EXPOSURE. THE FILM BIN IS DESIGNED TO BE USED BY X-RAY AND ULTRASOUND TECH IN A HOSP DARK ROOM. THE FILM BIN HOLDS FILM BOXES FOR DEVELOPING X-RAY AND ULTRASOUND FILMS. WHEN THE FILM BIN IS OPENED WITH ITS HANDLE TO THE FULLY OPEN POSITION, IT IS SUPPOSED TO REMAIN OPEN UNTIL CLOSED WITH ITS HANDLE. THE CONSTRUCTION OF THE BIN PREVENTS FILMS FROM BEING EXPOSED. THE FILM BIN WAS DEFECTIVE AND UNSAFE FOR ITS INTENDED PURPOSES AT THE TIME IT LEFT THE CONTROL OF DISTRIBUTOR. THE DESIGN PERMITTED THE FILM BIN TO SUDDENLY AND UNEXPECTEDLY SLAM CLOSED DUE TO THE ABSENCE OF ANY SORT OF CATCH OR STOP TO PROHIBIT THE DRAWER FROM SLAMMING CLOSED. A SAFER ALTERNATIVE DESIGN EXISTED AT THE TIME THE PRODUCT WAS MFG. THE SAFER ALTERNATIVE DESIGN WOULD HAVE PREVENTED OR SIGNIFICANTLY REDUCED THE RISK OF THE PLAINTIFF'S INJURIES, WITHOUT SUBSTANTIALLY IMPAIRING THE PRODUCT'S UTILITY. FURTHERMORE, THE SAFER ALTERNATIVE DESIGN WAS ECONOMICALLY AND TECHNOLOGICALLY FEASIBLE AT THE TIME THE PRODUCT LEFT THE CONTROL OF DISTRIBUTOR APPLICATION OF EXISTING OR REASONABLY ACHIEVABLE SCIENTIFIC KNOWLEDGE. THERE WAS NO WARNING THAT THE DRAWER COULD UNEXPECTEDLY AND SUDDENLY SLAM. (*)
THE SHEATH WAS IN PLACE FOR APPROX 3 HRS FOR THROMBOLYSIS THERAPY VIA A CATHETER TO A CLOTTED GRAFT IN THE PT'S RIGHT LEG. THE CATHETER BECAME CLOTTED AND BLEEDING WAS NOTED AT THE PUNCTURE SITE. IN AN EFFORT TO ACHIEVE HEMOSTATIS THE CATHETER WAS PULLED BACK. HOWEVER, THE SHEATH DISLODGED DURING THIS MANEUVER AND A RIGHT GROIN ABDOMINAL HEMATOMA DEVLEOPED. THE SHEATH WAS REPLACED AND TWO UNITS OF BLOOD WERE TRANSFUSED. THE PT'S CONDITION IS GOOD.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE DISCARDED.  THE DEVICE WAS DESTROYED/DISPOSED OF.
PERSONS EXPERIENCED REDNESS AND BLISTERING OF SKIN IN AREA WHERE TAPE WAS APPLIED. UNKNOWN NUMBER OF PERSONS INVOLVED. UNKNOWN IF MEDICAL TREATMENT WAS REQUIRED. UNABLE TO REACH FACILITY FOR FURTHER INFO AT TIME OF FILING, FACILITY NOT RETURNING CALLS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE DISTAL END OF G-TUBE BROKE OFF INSIDE PT. PT WAS TAKEN TO ER. X-RAYS WERE TAKEN AND SHOWED A PIECE OF THE TUBE APPROX 2CM IN LENGTH. DRS DECIDED TO LET PT PASS THE PIECE. PT LATER VOIDED OUT PIECE OF TUBE. CO WAS NOT INFORMED OF PT INVOLVEMENT UNTIL 3/28/96.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IPG WAS EXPLANTED BECAUSE IT HAD REACHED ELECTIVE REPLACEMENT INDICATORS (ERI) PREMATURELY. IMPLANT DATE 10/7/94. EXPLANT DATE 2/19/96. IMPLANTED 16 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AFTER POSITIONING THE INTRODUCER CATHETER INTO THE PT'S VESSEL AND WHEN ATTEMPTING TO ATTACH THE DELIVERY SYSTEM, THE HUB ON THE INTRODUCER CATHETER BROKE OFF. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME MAKE TO COMPLETE FILTER DEPLOYMENT TO THE TARGETED AREA WITH NO FURTHER COMPLICATIONS BEING REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DISTRIBUTOR BECAME AWARE OF AN EVENT THAT OCCURRED WHILE PERFORMING A DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE WIRE WAS REMOVED AND IT WAS NOTED THE COATING HAD SHEARED AND A SEGMENT REMAINED IN THE RIGHT ILIAC. A SNARE WAS ADVANCED VIA THE LEFT SIDE AND WAS USED TO SUCCESSFULLY RETRIEVE THE DETACHED COATING. THE PT EXPERIENCED NO SEQUELAE AS A RESULT OF THIS EVENT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE NOT USED AS LABELED/INDENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
PT EXPERIENCED PAIN AND SWELLING IN HER KNEE. THE KNEE WAS REVISED TO REPLACE WORN COMPONENTS. DURING SURGERY IT WAS DETERMINED THAT THE MEDIAL POSTERIOR POLY INSERT AND PATELLA COMPONENTS WERE WORN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT COMPLAINED OF PAIN. SURGEON SUSPECTED PLASTIC WEAR.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING A PROCEDURE THE BURR DEVICE "STALLED" AND VIBRATED. THE DEVICE WAS REMOVED FROM THE PT AND ON EXAMINATION A HOLE WAS DISCOVERED IN THE DEVICE. NO ADVERSE PT OUTCOME NOTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DISTRIBUTOR BECAME AWARE OF AN INCIDENT THAT OCCURRED DURING A DIFFICULT GASTROSTOMY TUBE PLACEMENT ON AN OBESE PT. DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE INTRODUCER CATHETER THROUGH THE PT'S EXTREMELY THICK ABDOMINAL WALL DUE TO ADIPOSITY. AN EXTREME AMOUNT OF FORCE WAS EXERTED ON THE INTRODUCER CATHETER DURING PLACEMENT AND THE CATHETER SLIPPED BENEATH THE PT'S SKIN. RETRIEVAL OF THE CATHETER REQUIRED FURTHER INCISION. HEMOSTATS WERE USED TO LOCATE AND REMOVE THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PT COMPLICATIONS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
IT WAS REPORTED THAT WHEN ATTEMPTING FILTER DEPLOYMENT BY A SUBCLAVIAN APPROACH, THE INTRODUCER CATHETER SLIPPED BACK OUT OF THE CAVA. THE INTRODUCER COULDN'T BE RE-POSITIONED SO THE ENTIRE SYSTEM WAS REMOVED AND REPLACED TO COMPLETE FILTER DEPLOYMENT TO THE TARGETED LOCATION. NO FURTHER COMPLICATIONS WERE REPORTED. EVENT DATE 3/96.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
OUTPATIENT REQUESTING DEEP SEDATION FOR MRI PROCEDURE. SEDATION ADMINISTERED BY CRNA. BURN SITES ON ANTERIOR CHEST NOTED IN POST ANESTHESIA CARE UNIT UPON REMOVAL OF EKG PATCHES. PHYSICIAN NOTED THE PATCHES WERE DRY, HAD NO GEL AND CAUSED A 2 DEGREE BURN 1-1 1/2" DIAMETER UNDER EACH PATCH. PT WAS EVALUATED IN ER AND DISCHARGED HOME WITH BURN TREATMENT INSTRUCTIONS. THE BIOMEDICAL DEPT PERFORMED AN ELECTRICAL SAFETY TEST AND INSPECTED THE MONITOR ON 3/8/96 PRIOR TO FURTHER UTILIZATION. PT'S ATTORNEY CONTACTED HOSP THE DAY AFTER THE OCCURRENCE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  INSUFFICIENT LUBRICATION.  CONCLUSION:  DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
RUPTURED BREAST IMPLANTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  OTHER.  CONCLUSION:  OTHER.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
BILATERAL BREAST EXCHANGE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE RIGHT BREAST IMPLANT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE BILATERAL BREAST IMPLANTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST EXCHANGE WITH CAPSULECTOMIES.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE AND CAPSULECTOMY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMIES.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
DURING A LAPAROSCOPIC PROCEDURE ON A 28-YR-OLD FEMALE WHO IS IN GOOD HEALTH, A LAPAROSCOPIC CAUTERY CORD WHICH WAS LOOSE DURING THE PROCEDURE, BECAME UNATTACHED FROM THE DISSECTOR AND INADVERTENTLY FELL ON THE DRAPES ABOVE THE PT'S FACE. THE PHYSICIAN WAS NOT AWARE THAT THE CORD HAD BECOME UNATTACHED AND STEPPED ON THE CAUTERY PEDAL. THE CORD BURNED THE PT ON THE LIP THROUGH THE DRAPES. ACTUAL EXTENT OF INJURY IS STILL BEING DETERMINED.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  CONNECTOR OR ADAPTOR.  CONCLUSION:  DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, USER ERROR CONTRIBUTED TO EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
THE PTS' KNEE WAS SWOLLEN AND PAINFUL. DR DETERMINED THAT THE PT NEEDED A TRI-COMPARTMENT IMPLANT. THE UNI-KNEE WAS REVISED TO A DURACON KNEE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
TWO PHYSICIANS AND THREE STAFF MEMBERS EXPERIENCED ITCHING, REDNESS, AND IRRITATED SKIN TO NOSE AREA WHILE USING THE FACE MASK. ONE STAFF MEMBER WENT TO DERMATOLOGIST AND RECEIVED UNKNOWN PRESCRIPTION.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  5.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
IPG EXHIBITED "NO OUTPUT, SETSCREW DAMAGED LEAD" AT THE TIME OF IMPLANT. A SECOND IPG WAS USED AND AFTER PROPER ANODE SET SCREW TIGHTENING, IT WORKED APPROPRIATELY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING A ROUTINE REPLACEMENT PROCEDURE OF AN ICD THE PT'S TWO RATE SENSING LEADS WERE CAPPED AND REMOVED FROM SVC BECAUSE THEY WERE ERODING. IMPLANT DATE 1/8/93. REMOVED FROM SVC 11/21/95. TOTAL IMPLANT TIME 33 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TWO STAFF MEMBERS EXPERIENCED SKIN IRRITATION WHILE USING FOGFREE FACE MASKS. BOTH STAFF MEMBERS APPLIED HYDROCORTIZONE CREAM TO AFFECTED AREAS. THE MFR HAS BEEN NOTIFIED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS MULTIPLE PATIENT INVOLVEMENT.  NUMBER OF PATIENTS INVOLVED:  2.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH AN ICD AND LEAD SYSTEM EXPERIENCED SENSING PROBLEMS. AN INVASIVE ANALYSIS WAS PERFORMED AND DAMAGED INSULATION WAS IDENTIFIED ON THE TWO UNIPOLAR (RATE SENSING) LEADS. THE PHYSICIAN ELECTED TO IMPLANT A NEW BIPOLAR (RATE SENSING) LEAD. THE LEADS IN QUESTION WERE CAPPED. IMPLANTED: 12/15/92, OUT OF SVC: 4/2/96. IMPLANTED 39 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH AN ICD AND LEAD SYSTEM HAD EXPERIENCED OVERSENSING/INAPPROPRIATE SHOCKS. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN FOUND THE LEAD IMPEDANCE OF THE TWO UNIPOLAR (RATE SENSING) LEADS TO BE ELECTRICALLY OPEN. THE TWO UNIPOLAR LEADS WERE CAPPED AND A BIPOLAR (RATE SENSING) LEAD WAS IMPLANTED. THE ICD WAS ELECTIVELY REPLACED. IMPLANTED: 7/28/94, OUT OF SERVICE: 3/6/96. IMPLANTED 19 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH A IPG WAS EXPERIENCING ATRIAL CAPTURE PROBLEMS. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE AND FOUND THAT THE IPG WAS PAST ERI AND IT WAS NON-PROGRAMMABLE. THE LEADS THAT WERE IMPLANTED WITH THIS IPG WERE MFG BY ANOTHER PACEMAKER CO. IMPLANTED 11/2/93. EXPLANTED 2/19/96.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHILE PERFORMING A LEFT HEART CATHETERIZATION PROCEDURE RESISTANCE WAS ENCOUNTERED ADVANCING THE WIRE. THE WIRE AND NEEDLE WERE REMOVED AS A UNIT. AFTER REMOVAL IT WAS NOTED A PORTION OF THE GUIDE WIRE AND NEEDLE WERE REMOVED AS A UNIT. AFTER REMOVAL IT WAS NOTED A PORTION OF THE GUIDE WIRE UNRAVELED AND DETACHED IN THE PT'S LEG. THE DETACHED SEGMENT WAS RETRIEVED SURGICALLY WITHOUT INCIDENT. THERE WERE NO PT COMPLICATIONS INVOLVED. NO FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT ARE AVAILABLE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
POLY WEAR ON TIBIAL INSERT. PT EXPERIENCING PAIN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PRODUCT WILL BE RETURNED TO THE MFR. AFTER POSITIONING THE INTRODUCER CATHETER INTO THE PT'S VESSEL AND WHEN ATTEMPTING TO ATTACH THE DELIVERY SYSTEM, THE HUB ON THE INTRODUCER CATHETER BROKE OFF. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED TO COMPLETE FILTER DEPLOYMENT TO THE TARGETED AREA WITH NO FURTHER COMPLICATIONS BEING REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SKIN IRRITATIONS WERE EXPERIENCED WHILE USING VINYL EXAMINATION GLOVES. ACCOUNT HAS NOT RETURNED PHONE CALLS. INVESTIGATION STILL ONGOING.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
POLY ON THE PATELLA BROKE OFF FROM THE METAL BACKING. PEGS ON THE PATELLA WERE WELL FIXED. IT WAS VERY DIFFICULT TO REMOVE THE PATELLA. PT EXPERIENCING PAIN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THORACENTESIS WAS PERFORMED USING THE 22G 2" NEEDLE FROM THE THORACENTESIS TRAY. 250CC FLUID WAS OBTAINED, AFTER INSTILLING LOCAL ANESTHESIA. UPON REMOVING THE 50CC SYRINGE (TO WHICH THE 22G NEEDLE WAS ATTACHED), THE NEEDLE CAME OFF OF THE RUBBER HUB. THE HUB REMAINED ATTACHED TO THE SYRINGE, WITH NO REMNANT OF THE NEEDLE ATTACHED. AN ATTEMPT WAS MADE TO RETRIEVE THE NEEDLE THROUGH A SMALL SKIN INCISION, BUT WAS UNSUCCESSFUL. THE PT WILL PROBABLY REQUIRE SURGICAL RETRIEVAL. THE DISTRIBUTOR IS RECALLING THE ENTIRE LOT.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  COMPONENT FAILURE.  CONCLUSION:  DEVICE DISCARDED - UNABLE TO FOLLOW-UP.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
REMOVAL OF CRACKED LEFT THUMB CONDYLAR IMPLANT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  NO.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
RIGHT BREAST IMPLANT REMOVED DUE TO RUPTURE, LEAK.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  MAYBE.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEAKING RIGHT CYLINDER OF PENILE IMPLANT. IMPLANT REPLACED. PT'S HEALTH IS GOOD.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  MAYBE.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A 7MM DRAIN WAS PLACED IN THE ABDOMEN PRIOR TO CLOSING ON 3/4/96. THE DRAIN WAS SUTURED EXTERNALLY; CLOSED INCISION AS USUAL. WHEN DR TRIED TO DISCONTINUE THE DRAIN ON 3/6 AFTER REMOVING THE SUTURE, THE DRAIN BROKE. THE PT RETURNED TO SURGERY ON 3/7/95 FOR ABDOMINAL EXPLORATORY SURGERY TO DETERMINE THE CAUSE AND RETRIEVE THE DRAIN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ON 5/16/95 PT UNDERWENT TURP WITH VAPORIZATION OF PROSTATE FOR OBSTRUCTIVE VOIDING SYMPTOMS. A VAPORTROBE LOOP AND RESECTOSCOPE LOOP WERE USED DURING PROCEDURE. 5/22/95: FOLLOW-UP VISIT STATUS POST TURP, SOME URINARY RETENTION NOTED. 6/8/95: POST-OP FOLLOW-UP. PT C/O PERSISTANT FREQUENCY AND NOTURIA. PT REASSURED THAT IT WAS STILL EARLY POST-OP DAYS. APPOINTMENT MADE TO RETURN IN TWO MONTHS. 8/14/95: FOLLOW-UP STATUS POST TURP. PT C/O URGENCY WITH SOME IRRITATION OF HIS MEATUS. 9/11/95: OFFICE VISIT, PT C/O IRRITATIVE VOIDING SYMPTOMS AND PASSIVE INCONTINENCE. PT SCHEDULED FOR CYSTOCOPY AND REFERRAL TO INCONTINENCE CTR. 10/26/95: PT REFERRED TO HOSP INCONTINENCE CTR.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A 59-YR-OLD FEMALE, NURSING HOME PT, HAD A JEJUNAL TUBE PLACED INTO AN EXISTING FEEDING TUBE IN 1/96. ON 3/2/96, THE PT WAS ADMITTED TO THE HOSP WITH ABDOMINAL DISCOMFORT AND SWELLING. AN ENDOSCOPY WAS PERFORMED AND REVEALED THAT THE "Y" CONNECTING PORT HAD PULLED AWAY FROM JEJUNAL TUBE LEAVING THE MAIN SHAFT LOOSE IN THE PT'S STOMACH. THE SHAFT WAS ENDOSCOPICALLY RETRIEVED USING A SNARE AND A NEW JEJUNAL TUBE WAS INSERTED. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PT WAS DISCHARGED BACK TO THE NURSING HOME.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
9/85 CLOSED CAPSULOTOMY, 5/86 HARDENING, 5/89 FATIGUE, 11/91 LUPUS, ALOPECIA, SLEEP DISORDER, SCLERODERMA, RAYNAUD SYNDROME, 9/90 PNEUMONIA, 10/93 HIGH FEVER, 7/94 ENLARGED LEFT LYMPH NODE, MITRAL VALVE PROLAPSE, ACTIVE VASCULITIS, SKIN ULCERATIONS.
LOSS OF VOLUME TO PT VIA VENTILATOR. NOTED ON 4/19/96 EARLY AM - WATER ON FLOOR UNDER CHAMBER. CHAMBER FOUND TO HAVE CRACKS; REMOVED AND REPLACED WITH ANOTHER CHAMBER WHICH CORRECTED THE PROBLEM. AFTER CHANGE ALL PARAMETERS AND PT STATUS RETURNED TO BASELINE.
A NURSE WAS ASPIRATING, FLUSHING AND ADVANCING THE CATHETER DURING INSERTION. WHEN SHE REACHED 6 INCHES, SHE FLUSHED THE CATHETER WITH 5CC OF NORMAL SALINE. PT STATED "SHE DID NOT FEEL WELL. "HER FACE WAS FLUSHED, HER PULSE WAS IRREGULAR SHE FELT NAUSEATED AND HAD CHEST DISCOMFORT." THEN THE NURSE GAVE HER A WASH CLOTH WHICH HELPED HER TO RELAX. PT STATED "SHE WAS NOT FEELING BETTER AND SHE WAS GOING TO PASS OUT." AT THIS POINT THE NURSE REMOVED THE CATHETER. AFTER THE CATHETER WAS REMOVED SHE STARTED TO FEEL BETTER AND 5 MINS LATER, SHE WAS ABLE TO GO BACK TO BED. HER DR WAS NOTIFIED AND 25 MG OF BENADRYL WAS GIVEN PO. AFTER 20 MINS PT WAS RESTING AND FEELING MUCH BETTER.
CATHETER CAME OUT WHILE PT IN BED. FRAGMENT OF FOLEY BALLOON APPEARED TO BE MISSING OR SPLIT. RETURNED TO OR FOR RETAINED BALLOON. CYSTOSCOPY PERFORMED AND NO FOREIGN BODY FOUND.
THIS IS THE FIFTH REPORTED INCIDENT INVOLVING THIS PRODUCT. SEE MEDWATCH REPORT DATED 9/28/95. THE US DISTRIBUTOR FOR THIS PRODUCT INFORMED HOSPS, FOLLOWING PREVIOUS REPORTS, THAT THE MFR IS AWARE OF THE PROBLEMS WITH THIS PRODUCT. APPARENTLY THERE IS A PROBLEM WITH THE MOLDING PROCESS AND CO HAS RECOMMENDATIONS AS TO HOW THE PRODUCT SHOULD BE TAPED TO PREVENT THIS FROM HAPPENING BUT HAS NOT CHANGED THEIR PACKAGING OR MADE ANY ATTEMPT TO NOTIFY THE CUSTOMER AS TO THE STEPS TO TAKE TO PREVENT THESE TYPES OF INCIDENTS FROM OCCURRING. BASED ON CONTINUED PROBLEMS WITH THIS PRODUCT, IT APPEARS AS IF THE MFR NEEDS TO PROVIDE FURTHER INSTRUCTION AS TO THE PROPER USE.
SURGICAL BED TILTED OVER WHEN POSITIONED FOR LITHOTOMY. WENT THROUGH THE DISTRIBUTOR TO CONTACT CO. STAFF HAS NO WAY OF KNOWING LEGS (BRAKES) HAVE LIFTED OFF GROUND. PROBLEM IS AVERTED IN ONE OF TWO WAYS. USE THE SMALLER TRANSPORT LEG SECTION OR PUT SPACERS IN HYDRAULICS TO PREVENT TABLE FROM GOING SO LOW. THE CO SAYS IT WILL SEND OUT LETTERS TO DIRECT USERS TO USE TRANSPORT BOARDS. THIS FACILITY HAS CHOOSEN TO HAVE THE SPACERS INSTALLED.
CATHETER WAS USED FOR TEST OCCLUSION. BALLOON RUPTURED AFTER BEING FILLED WITH 0.6 - 0.7CC CONTRAST (MFR RECOMENDED MAX VOLUME = 0.8CC), CAUSING VESSEL DISSECTION. BALLOON WAS TESTED WITH VOLUME OF 0.8CC BEFORE INSERTION, WITHOUT RUPTURE.
PT REPORTED TO HOME CARE NURSE THAT HE HAD RECEIVED AN ELECTRICAL SHOCK TO HIS LEFT HAND FROM THE BED CONTROL. A QUARTER SIZE BLACK MARK WAS NOTED ON THE PT'S LEFT HAND. NO OPEN AREA WAS NOTED. PT C/O BURNING IN LEFT HAND. AREA ASSESSED, CLEANSED AND DRESSED. PT REFERRED TO ER FOR FURTHER EVALUATION.
THE PT'S HEART RATE WAS 54. THE PT BECAME CYANOTIC AND WAS AMBU-BAGGED WITH 100% OXYGEN. THE PERFUSION PACER WAS TURNED ON AND BELIEVED TO BE SET AT 60. IT APPARENTLY MISPACED AT 160 BEATS PER MINUTE, NEARLY CAUSING THE PT TO GO INTO VENTRICULAR TACHYCARDIA. THE PACER WAS TURNED OFF. THE PT DID NOT SUSTAIN ANY LONG TERM EFFECT.
PT DEVELOPED HARD KNOT 2" ABOVE INSERTION SITE TWO DAYS AFTER INSERTION. 2 1/2 X 3" AREA REDDENED AND WARM TO TOUCH. INTERESTING PT HISTORY THAT PT HAS AN INTOLERANCE FOR CONTACT LENSES. FELT SYMTOMS MAY BE REACTION TO CATHETER MATERIAL. ANOTHER BRAND PICC PLACED WITH NO RESULTANT ADVERSE SYMPTOMS DEVELOPING.
TRANSDUCER LINE KINKED. SALINE LINE WON'T UNCAP.
TAMP BROKE WHILE BEING USED. PIECES RECOVERED FROM FLOOR AND IT WAS NOTED THAT A SMALL SLIVER WAS MISSING. THE PHYSICIAN WAS NOTIFIED AND THE WOUND WAS IRRIGATED.
DURING SURGICAL PROCEDURE, BILATERAL TOTAL KNEE REPLACEMENTS, A PIECE OF THE POSTERIOR TIBIAL RETRACTOR TIP (APPROX 0.5 CM) BROKE OFF ON THE SURGICAL AREA WHILE PERFORMING REPLACEMENT OF THE LEFT KNEE. X-RAY WAS TAKEN AND DID NOT REVEAL ANY OBJECTS AT THE SURGICAL AREA.
WHILE TRYING TO REMOVE OLD SCREWS FROM PT'S LEFT FEMUR WITH A SCREW EXTRACTOR FROM TOTAL JOINT CONVERSION, THREE POINTS OF THE INSTRUMENT BROKE OFF INTO THE PT'S TISSUES. NO ATTEMPT WAS MADE TO RETRIEVE THE PIECES.
SCREW DRIVER BROKE DURING ORTHO CASE. ORT HAD INJURY TO RIGHT INDEX FINGER.
PT WAS BEING MONITORED FOR PULMONARY ARTERY PRESSURE. DEVICE WORKED FOR APPROX 40 HRS AND WAS THEN DISCONNECTED SO PT COULD BE TRANSPORTED FOR CAT SCAN. WHEN PT WAS RETURNED TO UNIT AND DEVICE RECONNECTED, IT FAILED TO WORK. PROBLEM WAS IDENTIFIED AS TRANSDUCER FAILURE BASED ON THE OPINION OF THE NURSE CARING  FOR THE PT.
AN ELDERLY GENTLEMAN WAS ADMITTED FOR BACK SURGERY WITH PAST HISTORY OF STROKE WHICH AFFECTED THE RIGHT SIDE OF HIS BODY. AFTER ADMISSION PT COMPLAINED OF MUSCLE SPASMS TO HIS RIGHT LEG. AN ORDER WAS WRITTEN BY THE PHYSICIAN FOR HEATING PAD APPLICATION. AFTER A COUPLE OF DAYS REDNESS AND SWELLING WAS NOTED BY A NURSE AND SHE QUESTIONED THE PT (0200 HRS ON TUESDAY, 1/16/96). THE PT STATED THAT HE NOTICED IT ABOUT TWO DAYS AGO, AFTER THE USE OF THE "BLUE PAD." TEMP SETTING OF THE PAD WAS NOT NOTED AT THE TIME IT WAS REMOVED FROM THE PT. THE SIZE OF THE DISPOSABLE BLANKET IS 24" X 60". PT SUSTAINED A FIRST-DEGREE BURN (REDNESS, SWELLING) TO THE RIGHT LOWER LEG. THE PAD WAS USED TO HELP RELIEVE MUSCLE SPASMS. HOW LONG THE PAD WAS IN USE PRIOR TO THE PT INJURY IS NOT KNOWN. THE PAD WAS BENCH TESTED BY BIOMEDICAL EQUIPMENT REPAIR TECH. THE TEMP SELECTION OF 100 DEGREES FAHRENHEIT PRODUCED 100 DEGREE FAHRENHEIT AND SELECTION OF 105 DEGREES FAHRENHEIT PRODUCED 103 DEGREES FAHRENHEIT. IN BRIEF, THE PAD HEATING MODULE BENCH TESTED AS PER MFG'S SPECS.
ON 3/11/93 WHILE LIVING IN FLORIDA PT WAS IMPLANTED WITH AN ARTIFICIAL URINARY SPHINCTER, AFTER A PROSTATE CANCER OPERATION. BY THE END OF 1994 HE BEGAN TO HAVE A SMALL PATCH OF RED ITCHY RASH ON ONE ARM, BY 1995 THE RASH HAD SPREAD ALL-OVER HIS BODY FROM NECK TO ANKLES. AT THE TIME HE WAS GIVEN SEVERAL TYPES OF TOPICAL CREAMS, NOTHING WORKED. HE HAD BEEN ON MEDICATION (VARAPAMIL CHANGED LATER TO DIALTIAZEM) MEDICATION WAS DISCONTINUED RASH PERSISTED. IN 1996 A DERMATOLOGIST DID A BIOPSY FROM ONE OF THE LESIONS ON HIS LOWER BACK AND THE RESULTS WERE "ALLERGIC REACTION." PT WAS PUT ON PREDNISONE, AND IT HAS BEEN KEEPING THE RASH DOWN, BUT WHEN IT WAS STOPPED FOR 3 WEEKS THE RASH REAPPEARED. AT SOME POINT HIS DR HAD HIM CHECKED BY ANOTHER DR WHO SUGGESTED CALLING THE MFR HOPING THAT A PIECE OF THE IMPLANT'S MATERIAL COULD BE MADE AVAILABLE TO PUT ON ONE OF THE PT'S ARMS TO SEE IF THE REACTION OCCURRED AGAIN. AT FIRST THE MFR WANTED TO DO THE EXPERIMENT BUT LATER REFUSED TO DO IT. THE IMPLANT IS MADE WITH "SOLID SILICONE ELASTOMETER," AND AT THE TIME OF THE OPERATION AND IMPLANTATION PT WAS NOT GIVEN ANY ALLERGY TESTS TO SEE IF HE COULD BE ALLERGIC TO THE MATERIAL. WHEN HE STARTED HAVING THE ALLERGIC REACTION THE RPTR CALLED THE HOSP INQUIRING ABOUT THE PROBLEM, AND THEY WERE TOLD THAT THE HOSP HAD NEVER HAD A SIMILAR PROBLEM WITH ANY OF THE OTHER PTS THAT HAD RECEIVED THE SAME IMPLANT.
THE SOCKET IS CONSIDERABLY UNDERSIZED FOR ITS INTENDED OPERATION. THE CORNERS OF THE SOCKET ARE = 1/16", CAUSING THE SOCKET TO SPLIT AT THESE LOCATIONS DURING NORMAL OPERATION, THUS RENDERING THE KIDNEY BRIDGE INOPERABLE. RPTR RECOMMENDS THAT THE SOCKETS BE MADE THICKER OR THAT THE MFR USES A STRONGER MATERIAL. THE HAND CONTROL HAS BEEN A PROBLEM SINCE RPTR RECEIVED THE TABLES. DUE TO THEIR SMALL HANGING BRACKET, THEY ARE VERY SUSCEPTIBLE TO BEING KNOCKED OFF THE SIDE RAILS DURING ARMBOARD INSTALLATION OR HEADREST REMOVAL. THIS CAUSES THE HAND CONTROL TO FALL TO THE FLOOR AND, BECAUSE OF NO PROTECTIVE PADDING, JAR LOOSE ELECTRICAL CONNECTIONS. RPTR RECOMMEND ONE OF TWO SOLUTIONS: (1) CREATE A BETTER MOUNTING ASSEMBLY OR (2) PROVIDE A PROTECTIVE COVER (IE, A RUBBER CASE WHICH WILL ONLY LEAVE THE PUSH BUTTONS ACCESSIBLE).
SUBJECT MASKS ARE EXTREMELY IRRITATING TO FACIAL SKIN AND MUCOUS MEMBRANES OF SURGICAL STAFF. THE IRRIGATION CAUSED BY THESE MASKS ESPECIALLY IN LONG PROCEDURES ARE A DISTRACTION TO THE SURGICAL TEAM.
VENTED TUBING REMOVED FROM PACKAGING AND CONNECTED TO ALBUMIN. UPON PRIMING THE LINE, THE ALBUMIN FLUID BEGAN TO LEAK FROM THE LOWER 1/3 OF THE TUBING. PACKAGING WAS INTACT UPON OPENING THE PRODUCT AND TUBING APPEARED TO BE CRUSHED. THE TUBING WAS DISCARDED BY THE USER.
RPTR HAD TWO TRACK MOUNTED VERSIONS OF THE SYSTEM THAT HAVE HAD ONGOING PROBLEMS WITH BRUSHES OVERHEATING. THE BRUSHES MAKE CONTACT WITH POWER BY PRESSING AGAINST CONTACT STRIPS IN THE "SIDE EXTRUSIONS," WHICH GO FROM END TO END AND ACT AS A DRESS COVER FOR THE MOUNTING TRACK. THE SIDE EXTRUSIONS ARE MADE FROM FLEXIBLE PLASTIC. THE PLASTIC APPARENTLY WARPS OR BENDS, MOVING THE EXTRUSION AWAY FROM THE BRUSHES. RPTR THEN GETS ARCING FROM THE CONTACT STRIPS TO THE BRUSHES. THIS CAUSES BURN (MELT) SPOTS ON THE SIDE EXTRUSION, AND HEATS THE BRUSHES. WHEN THE BRUSHES BECOME HOT, THE PLASTIC BRUSH HOUSING ALSO OVERHEATS. THE TERMINAL INSERTS ON THE BACK OF THE BRUSH HOUSING (HOT, NEUTRAL AND GROUND CONNECTIONS) NOW SLIP OUT OF THE HOSUING, MOVING THE BRUSHES FARTHER FROM THE CONTACT STRIPS UNTIL THE LAMP LOSES POWER COMPLETELY. CO HAS BEEN ACTIVELY INVOLVED IN REPLACING BRUSH HOUSING ASSEMBLIES, SIDE EXTRUSIONS, AND ADDING SPACERS TO MOVE THE BRUSH HOUSING ASSEMBLIES CLOSER TO THE CONTACTS. ONE UNIT HAS HAD 4 BRUSH ASSEMBLIES AND THREE SIDE EXTRUSIONS REPLACED, AND THE OTHER UNIT HAS HAD 5 BRUSH ASSEMBLIES REPLACED (EACH UNIT CONSISTS OF THREE LAMPS AND BRUSH ASSEMBLIES) IN THE COURSE OF ONE YEAR. CO HAS BEEN ACTIVELY INVOLVED IN REPLACING BRUSH HOUSING ASSEMBLIES, SIDE EXTRUSIONS, AND ADDING SPACERS TO MOVE THE BRUSH HOUSING ASSEMBLIES CLOSER TO THE CONTACTS. ONE UNIT HAS HAD 4 BRUSH ASSEMBLIES REPLACED (EACH UNIT CONSISTS OF THREE LAMPS AND BRUSH ASSEMBLIES) IN THE COURSE OF ONE YEAR. IT IS OBVIOUS THERE IS A BRUSH TO SIDE EXTRUSION CONTACT PROBLEM, AND CO IS LOOKING FOR A RESOLUTION.
THE CONTAINER IS PRIMARILY USED FOR COLLECTION AND TRANSPORT OF URINE SPECIMENS, ALTHOUGH OTHER INFECTIOUS MATERIAL IS ALSO PLACED IN THESE CONTAINERS. THE CAP IS DIFFICULT TO PLACE ON THE CONTAINER, ESPECIALLY WHEN HOLDING A LIQUID. PTS ARE NOT ABLE TO SEAL THE CONTAINER AFTER SPECIMEN COLLECTION. THIS ALLOWS POTENTIAL COMPROMISE OF THE SPECIMEN RESULTING IN SPECIMEN REJECTION) AND POSES AN INFECTION CONTROL HAZARD. THIS PART NUMBER IS NOT SCREW ON A TYPE LID, AS SPECIFIED FOR THIS NATIONAL STOCK NUMBER, IT HAS A SNAP-ON LID.
ALL MASKS ARE MISSING A ONE-WAY VALVE, WHICH MAKES IT A NON-REBREATHER.
THIS ALGINATE IMPRESSION MATERIAL IS BEING SUBSTITUTED FOR A DIFFERENT MATERIAL. THE OTHER MATERIAL HAS BEEN IN USE FOR OVER 30 YEARS WITH EXTENSIVE DOCUMENTATION IN USAF AND OTHER LAB INVESTIGATION STUDIES. THESE STUDIES INCLUDED STONE COMPATIBILITY, SURFACE REPRODUCTION, RESISTANCE TO PLASTIC DEFORMATION, RESISTANCE TO DISINFECTION AGENTS, ETC.REPORT MATERIAL SEEMS TO BE A NEW AND UNKNOWN MATERIAL BECAUSE IT IS NOT INCLUDED IN IMPORTANT CURRENT LITERATURE INVESTIGATION REPORTS. ITS PHYSICAL PROPERTIES SEEM TO BE INFERIOR TO THE OLDER MATERIALS. WHEN RECOMMENDED WATER AND POWDER MEASUREMENTS WERE MADE BY WEIGHT, THE FOLLOWING RESULTS WERE OBTAINED: 1) WHEN MIXED WITH MECHANICAL SPATULATION UNDER VACUUM, ITS CONSISTENCY IS GRAINY AND LUMPY INSTEAD OF SMOOTH AND CREAMY; 2) IT SETS TOO FAST (2.5 MIN AT 70 DEGREES FAHRENHEIT), LIMITING CONSIDERABLY THE WORKING TIME; 3) SURFACE REPRODUCTION IS TOO ROUGH AND CHALKY TO BE USED FOR MASTER CASTS FOR RPD'S; 4) POOR OR NO FIT OF RPD'S CAN ALSO BE ATTRIBUTED TO THIS MATERIAL; 5) STONE COMPATIBILITY WITH OTHER MATERIALS HAS NOT BEEN DETERMINED. IDENTIC SHOULD BE PULLED FROM DEPOT STOCK AND EVALUATED BEFORE IT IS CONSIDERED AS A SUBSTITUTE IMPRESSION MATERIAL AND THE OLDER MATERIAL SHOULD BE RE-INSTATED AS PRIMARY.
UNIT OF ISSUE IS A PACKAGE OF 100 INDIVIDUALLY SEALED PACKETTES CONTAINING ONE COTTON GAUZE PAD IMPREGNATED WITH ISOPROPYL ALCOHOL. AFTER SEVERAL COMPLAINTS FROM END USERS THAT EVERY OTHER PACKETTE DID NOT CONTAIN THE GAUZE PAD, MEDICAL WAREHOUSE STOCK WAS CHECKED. THE RESULTS OF QUALITY ASSURANCE CHECK ON SEVERAL CASES CONTAINING 10 PACKAGES INDICATES THAT 33 OF THE 100 PACKETTES IN EACH UNIT OF ISSUE PACKAGE DOES NOT CONTAIN THE COTTON GAUZE PAD.
UNIT'S VACUUM IS NOT WORKING. FIBEROPTIC HANDPIECE NOT WORKING. GETTING SHOCKED BY THE UNIT EVEN THOUGH GROUNDED WITH POWER TURNED OFF.
THE STAPLER WAS PUT IN PLACE AND THE SURGEON FIRED IT. THE STAPLE LINE DID NOT FIRE CORRECTLY. THE STAPLES THAT FIRED WERE OUT OF ALIGNMENT AND HAD TO BE REMOVED.
DURING A ROUTINE PAP THE LOWER BLADE OF THE SPECULUM DEVELOPED A LINEAR CRACK IN THE CENTER OF THE BLADE 6 CM LONG. THERE WAS NO INJURY TO PT.
THE CURRENT SKIN CLOSURE TAPES, STRIPS ARE MARKEDLY INFERIOR TO ANOTHER BRAND STRIPS. SURGEON IS EXPERIENCING COMPLICATIONS WITH SURGICAL WOUND CLOSURES IN INFANTS BECAUSE THE STRIPS ARE OVERLY STIFF AND HAVE POOR ADHESIVE PROPERTIES. SURGEON NEEDS THE OTHER BRAND STRIPS FOR USE IN PEDIATRIC SURGERY.
AFTER SWITCHING TO THE NEW STRIP STERILE SKIN CLOSURES FROM THE MUCH PREFERRED, BETTER QUALITY STRIP SKIN CLOSURES, ALL RPTR HEARS FROM SURGEONS AND RESIDENTS ARE COMPLAINTS ABOUT THE PRODUCT. THE STRIP CLOSURES DO NOT WORK. THE STRIP CLOSURES DO NOT STICK AS WELL AS THE OTHER BRAND STRIPS. FREQUENT REPLACEMENT OF THE INEFFECTIVE STRIP SKIN CLOSURES INCREASE SURGICAL MORBIDITY OF THE WOUND. VERY BAD SCARS ARE LEFT. ANY GAIN IN COST DIFFERENTIAL IS DEFEATED BY USING THE LOW QUALITY STRIP CLOSURES DUE TO FREQUENT REPLACEMENT OF THESE INEFFECTIVE STRIPS. THE STRIP SKIN CLOSURES ARE UNSATISFACTORY AND RPTR STRONGLY RECOMMENDS THAT HOSP IMMEDIATELY SWITCH BACK TO THE GOOD STRIPS THAT WORK.
SKIN CLOSURES DO NOT ADHERE TO THE SKIN.
THE #15 KNIFE BLADES ARE DULL AND CANNOT BE USED TO PERFORM SURGERY. RPTR WANTS TO DISCONTINUE STOCKING #15 BLADES AND REPLACE THEM WITH ANOTHER MFR'S PRODUCT. THESE BLADES ARE VERY POOR QUALITY AND ARE A WASTE OF MONEY.
ATTEMPTED TO START AN IV ON A PT THREE DIFFERENT TIMES. TWO PEOPLE STARTED THESE IVS. EACH TIME, THE IV THREADED INTO THE VEIN AND THEN COLLAPSED UPON ITSELF. RPTR DID GET BLOOD FLASH BACK, BUT COULD NOT RUN FLUIDS. THE CATHETER TIPS ARE COLLAPSED WHEN RPTR TAKES THEM OUT OF THE PT.
THE SURGICAL BOWL IS LABELED "STERILE" BY THE CO ON ITS PACKAGING, HOWEVER, A GOOD NUMBER OF BOWLS HAVE BEEN FOUND TO BE VISIBLY DIRTY BY LOOKING INTO THE CLEAR PLASTIC PACKAGING. SOME BOWLS HAVE BLACK GREASE VISIBLE, OTHERS WHAT LOOKS LIKE LIGHT BROWN DIRT, WHILE OTHERS HAVE PARTICLES WITHIN THE PACKAGE.
UPON USING BLOOD BAGS IN THE PAST AND PRESENT IN THE BLOOD DONOR CTR, RPTR HAS FOUND THAT THE NEEDLE USED BY THIS CO IS OF VERY POOR QUALITY. AS A RESULT, THE NUMBER OF TRAUMATIC PHLEBOTOMIES AND UNSUCCESSFUL BLOOD UNITS HAVE INCREASED. A LARGE NUMBER OF DONORS HAVE MENTIONED THE DIFFERENCE IN THESE NEEDLES COMPARED TO ANOTHER CO'S NEEDLE RPTR HAS USED IN THE PAST. IN TURN, RPTR IS LOOKING OUT FOR THE DONORS COMFORT AND A GREATER NUMBER OF TRANSFUSABLE BLOOD DONATIONS COLLECTED.
CARDIAC REHABILITATION HAS HAD POOR READINGS ON THEIR COMPUTERS SINCE USING THIS PARTICULAR ELECTRODE. THEY HAVE HAD TO CONSTANTLY REPLACE THEM WITH ANOTHER LOT NUMBER. MOST OF THE ELECTRODES FROM THIS LOT SEEM TO BE DRY IN THE MIDDLE PART WHEN THEY SHOULD BE MOIST. THIS EFFECTS THE READOUTS OF RESULTS, CAUSING WRONG OUTPUTS.
WHEN THE STAPLER WAS USED TO STAPLE PANCREAS OFF, THERE WAS AN APPARENT MISFIRE. STAPLES DID NOT EJECT, PT LACERATED AND RESULTED IN 600CC EBL AND ADDED APPROX 1 HR TO THE CASE.
ON 10/19/95 ORTHOPEDIC CLINIC SURGICAL TECH, REPORTED AN INCIDENT WITH A PT. WHILE TECH WAS ROLLING THE ITEM ON A PT'S CALF, A NAIL IN THE CASTING ROLL POKED THROUGH, NARROWLY MISSING HER FINGER AND THE PT'S LEG.
WHEN THE CAP IS REMOVED FROM THE RAZOR THE TOP OF THE BLADE HOLDER (YELLOW PORTION) COMES OFF AND EXPOSES THE ENTIRE RAZOR BLADE.
THE ELECTROHYDRAULIC LITHOTRIPTOR PROBE WAS USED FOR A RIGHT URETEROSCOPY/LITHOTRIPSY. THE PROBE WAS INSERTED INTO THE PT AND WHEN THE DR WITHDREW THE PROBE THE TIP WAS NOT PRESENT. THE TIP REMAINED IN THE PT'S RIGHT KIDNEY. THE DR WAS UNABLE TO RETRIEVE THE TIP. IF THE TIP DOES NOT PASS THROUGH THE PT'S SYSTEM IT WILL PROBABLY CAUSE A STONE TO DEVELOP.
PRODUCT HAS BEEN SHEARING OFF DURING ROUTINE USE. THE BUR BREAKS IN THE MIDDLE OF THE BUR'S CUTTING EDGE, AS WELL AS IN THE AREA WHERE THE CUTTING EDGES MEET THE SHANK. BURS WERE BREAKING OUT OF THE PACKAGE (THEY WERE NOT STERILIZED).
RPTR IS NOW RECEIVING A STERILE TUBE INSTEAD OF THE STERILE PEEL FOIL PACK FROM THE DEPOT. WHEN THE TUBE IS CUT OPEN THE TIP OF THE TUBE BECOMES UNSTERILE. WHILE PULLING THE GAUZE OUT OF THE TUBE THE PETROLEUM GAUZE TOUCHES THE TIP OF THE TUBE MAKING IT UNSTERILE (THE OPERATING ROOM IS A STERILE ENVIRONMENT). THIS ITEM IS NOT SUITABLE FOR PROPER SURGICAL CARE IN THE OPERATING ROOM OTHER. ACTIVITIES CAN STILL USE THIS ITEM.
THIS COMPLAINT WAS SUBMITTED BY THE NEONATAL DEPT. THERE ARE NO DEPTH MARKINGS IN THE TUBE. THE END FEELING PORT IS TOO SMALL, CAUSING FEEDING DEVICE TO GET STUCK ON END. THE TUBE MATERIAL IS TOO STIFF, CAUSING MUCOSAL TEARING UPON INSERTION.
SKIN CLOSURES DO NOT ADHERE TO THE SKIN. EVEN AFTER THE APPLICATION OF MASTISOL OR TINCTURE OF BENZOINE, THESE SKIN CLOSURES WILL NOT ADHERE PROPERLY.
COMPLAINANT IS 76 YEARS OLD WITH A PACEMAKER. HE WAS INTERESTED IN BUYING A HOUSE WITH A TRANSFORMER IN FRONT SO HE CALLED THE FIRM. AT FIRST THEY TOLD HIM THAT IT WAS NO PROBLEM, BUT AFTER HE TOLD THEM HIS PACEMAKER AND LEAD NUMBER THE PERSON ON THE PHONE TOLD HIM HE HAD A DEFECTIVE LEAD. HE NEVER RECEIVED NOTIFICATION ABOUT THE DEFECT FROM THE CO OR HEALTHCARE ORGANIZATION. CONSUMER HAS A LAWYER. WAS INTERESTED IN THE CLASSACTION SUITE AGAINST MFR.
DENTAL CALLED MEDICAL MAINTENANCE TO REPORT THAT AN AUTOCLAVE (STEAM), EXPLODED. INVESTIGATION DONE. A DR AND A TECH WHO ARRIVED AT THE SCENE FIRST, SAID THEY HEARD A LOUD NOISE AND RAN DOWN TO THE ROOM TO FIND THE DOOR SLIGHTLY OPEN WITH WATER COMING FROM THE BOTTOM OF THE UNIT. MAINTENANCE FOUND FRAGMENTS SCATTERED AROUND THE ROOM AND LATER DISCOVERED TO BE PIECES OF THE BEARING ASSEMBLY. FURTHER INVESTIGATION FOUND THAT THE BEARING ASSEMBLY CRACKED WHILE THE UNIT WAS UNDER PRESSURE, LEAVING A GAP ABOUT A 1/4" BETWEEN THE DOOR AND WHERE THE BEARING ASSEMBLY PRESSES AGAINST THE DOOR. THIS CAUSED THE DOOR TO OPEN, FRAGMENTS OF THE BEARING ASSEMBLY INTO THE ROOM. A CONVERSATION WITH TECH-SVS AT MFR, INFORMED RPTR THAT THIS PROBLEM IS CAUSED BY OVER TIGHTENING OF THE DOOR ASSEMBLY. THEY HAVE A MODIFICATION KIT FOR THIS MODEL. THE CO HAS BEEN REPLACING THE DOOR ASSEMBLY ONLY IF THE PROBLEM HAS OCCURRED AND REPORTED TO THEM.
THE CUSTOMER'S REPORT MAY BE CAUSED BY THE PACKAGING CONFIGURATION. THE ELECTRODE CORDS ARE PLACED ON THE RELEASE SIDE OF THE ELECTRODE. THE PADS ARE THEN PLACED FIFTY TO A CASE. THE THIN AREAS IN THE POLYHESIVE ARE CAUSED BY THE NESTING PRESSURE OF BOXED ELECTRODES. THIS SHOULD POSE AS NO SAFETY CONCERN AS THE COATED PORTION OF THE ELECTRODE HAS FAR LOWER IMPEDANCE THAN THE UNCOATED PORTION. ADDITIONALLY, THE GENERATOR'S REM SYSTEM SHOULD DETECT AN UNSAFE CONDITION.
SHARPS CONTAINERS DO NOT PROVIDE A MEANS FOR REMOVING THE NEEDLE FROM THE VACUUM SYRINGE. THE SHARPS CONTAINER MUST HAVE A RECEPTACLE FOR REMOVING THE NEEDLE SINGLE HANDEDLY IN ACCORDANCE WITH UNIVERSAL PRECAUTIONS POLICIES, COLLEGE OF AMERICAN PATHOLOGIST AND OSHA REGULATIONS. DURING AUTOCLAVE PROCEDURES THE PLASTIC BECOMES SOFT AND ALLOWS SHARPS TO PROTRUDE THROUGH THE PLASTIC. THESE SITUATIONS CREATE SEVERE HAZARDS WHICH CAN JEOPARDIZE THE SAFETY OF LAB PERSONNEL AND ANYONE ELSE HANDLING SHARPS CONTAINERS IN THE HOSP.
AFTER BETADINE PREP AND DRAPE, 25GA NEEDLE INSERTED AT L3-L4 WITH PT RIGHT SIDE DOWN. STYLET WITHDRAWN AND SMALL DARK FOREIGN BODY NOTED INSIDE NEEDLE HUB. CSF FLOWING OUT, FLOATED FOREIGN BODY TO EDGE OF HUB. NEEDLE MOVED AND SENT TO PATHOLOGY. SECOND 25GA NEEDLE INSERTED AND SUCCESSFUL SPINAL ANESTHESIA OBTAINED. NEEDLE SENT TO PATHOLOGY FOR EXAMINATION AND CULTURE. NONE (PT'S OPERATION WAS TO BE RIGHT INGUINAL HERNIORRAPHY, BUT WAS CANCELLED DUE TO SURGEON'S CONCERN FOR POSSIBILITY OF INFECTION (REMOTE POSSIBILITY).
RESIDENT FOUND WITH LIFELESS BODY PARTIALLY OFF THE BED BETWEEN THE SIDERAIL AND HEADBOARD. BED WITH 3/4 LENGTH SIDERAILS IN RAISED POSITION.
RESIDENT FOUND LIFELESS BODY PARTIALLY OFF THE BED BETWEEN THE SIDERAIL AND HEADBOARD. BED WITH 3/4 LENGTH SIDERAILS IN RAISED POSITION.
YAG LASER SET UP AND CALIBRATED ACCORDING TO POLICY. AIMING BEAM CHECKED AND APPROPRIATE LASER FIBER INSERTED IN THROUGH ENDOSCOPE. AIMING BEAN WORKED, THEN CUT OUT. APPARENT OUTPUT FROM LASER DROPPED AFTER MALFUNCTION. NO APPARENT INJURY TO PT.
FIBROCYSTIC DESEASE; BILATERAL BREAST RECONSTRUCTION 1983; MULTIPLE COMPLAINTS, VAGUE PAINS. FOR REMOVAL OF IMPLANTS, EXCISION OF CAPSULE.
CLEAR TUBING HAS BROKEN OFF AT WHITE PLASTIC CONNECTION ON THE SIDE OF THE CLEAR VALVE PART.
IMPLANTED CATHETER-RESERVOIR IN PT'S HEAD HAD BROKEN INTO TWO SEPARATE PIECES. BOTH BROKEN PIECES REMOVED, AND NEW CATHETER-RESERVOIR REPLACED UNDER GENERAL ANESTHESIA.
VENTRICULOPERITONEAL SHUNT HAD FRACTURED VALVE AFTER APPROX 23 MONTHS OF USE. CHILD REQUIRED SURGERY AND 6 DAY HOSP STAY.
FIO2 ON VENTILATOR WAS SET TO DELIVER 50% OXYGEN BUT WAS FOUND TO BE DELIVERING 55% OXYGEN. THE PT WAS VENTILATED BY HAND AND THE VENTILATOR CHANGED. THE VENTILATOR WAS RETURNED TO THE MFR AND THE OXYGEN CONTROL MODULE WAS REPLACED. THERE WAS NO INJURY TO THE PT. THE OXYGEN SATURATIONS FLUCTUATED DURING THIS EVENT.
FIO2 ON VENTILATOR WAS SET TO DELIVER 25% OXYGEN BUT WAS FOUND TO BE DELIVERING 40% OXYGEN. THE PT WAS VENTILATED BY HAND AND THE VENTILATOR CHANGED. THE VENTILATOR WAS RETURNED TO THE MFR AND THE OXYGEN CONTROL MODULE WAS REPLACED. THERE WAS NO INJURY TO THE PT. THE OXYGEN SATURATIONS ON THIS INFANT FLUCTUATED WIDELY DURING THIS EVENT.
ON 1/5/96, IT WAS NOTED AFTER COMPLETION OF SURGERY THAT THE SURGICAL LIGHT HANDLE CONTAINING THE CAMERA LENS WAS MISSING A NUT. THIS LIGHT IS POSITIONED DIRECTLY ABOVE THE STERILE FIELD BY THE SURGEON IN ORDER TO PROVIDE BETTER VISUALIZATION OF THE OPERATIVE SITE. THE LOCAL REPAIR SVC FOR THE MFR WAS CALLED WHO REPLACED THE ENTIRE LIGHT HANDLE AS THIS WAS THE SECOND TIME THIS HAD HAPPENED. THE SAME THING OCCURRED ON 1/25/96. ON 4/11/96, IN CLEANING THE OPERATING ROOM AFTER COMPLETION OF A CASE IT WAS AGAIN NOTED THAT A NUT WAS MISSING FROM THE LIGHT HANDLE AFTER THE ENTIRE CAMERA "FELL OFF" THE SURGICAL LIGHT. THE MFR WAS CALLED WHO NOTED THAT THE LOCAL INSTALLER HAD USED THE WRONG TYPE OF BOLTS AND NUTS WHEN THE ORIGINAL INSTALLATION OF THE LIGHT WAS DONE ON 8/4/95. BOLTS AND NUTS WERE THEN REPLACED WITH AIRCRAFT BOLTS AND NUTS.
DURING THE INSERTION OF A TRIPLE LUMEN CATHETER THE GUIDE WIRE BECAME UNRAVELED INSIDE THE PT. WHEN THE PHYSICIAN REMOVED THE GUIDE WIRE, IT WAS DOWN TO A SINGLE THREAD. THE ATTEMPT TO INSERT THE CATHETER UTILIZING THE SAME GUIDE WIRE HAD BEEN DONE THREE PREVIOUS TIMES (ALL ON THE SAME OCCASION). ON THE FIRST THREE OCCASIONS THE PHYSICIAN WAS UNABLE TO THREAD THE GUIDE WIRE DUE TO MEETING AN OBSTRUCTION.
RPTR COMPLAINS OF: CHRONIC INFECTIONS, INTESTINAL CYSTITIS, BLOOD PRESSURE LOW, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, CARPAL TUNNEL SYNDROME, MOTOR NEURON DISEASE, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ATYPICAL M-S, CHEST PAIN, DISCOLORATION AND TEMPERATURE SENSITIVITY OF EXTREMITIES, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME, HYSTERECTOMY, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, SEVERE HEADACHES, HEART PROBLEMS, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, ATYPICAL LUPUS, SCLERODERMA, JOINT INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, CAN'T AFFORD X-RAYS, UNABLE TO INHALE PROPER AMOUNT OF OXYGEN AT X-RAY TIMES, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS AND GROIN, CHRONIC UNEXPLAINED MUSCLE SPASMS, MUSCLE PAIN AND BURNING, MUSCLE ATROPHY, FIBROMYALGIA, MYOSITIS OR POLYMYOSITIS, FASCITIS, UNEXPLAINED RASHES, SUN SENSITIVE, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, DERMATOMYOSITIS, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, VASCULITIS, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICANOMAS, CLUMSINESS/DROPPING THINGS, MISJUDGING DISTANCE/RUNNING INTO OBJECTS, SICCA.
DURING EMERGENCY TRACH CHANGE ON 2/4/96 AT 2145 TWO SEALED CUSTOM TRACH TUBES WERE OPENED BY MOTHER AND FATHER TO REVEAL WHAT APPEARED TO BE SILICONE FLAKING INSIDE AND AROUND JUNCTURE OR FLANGE AND THE HYPERFLEX TRACH TUBE. TUBE IS CHANGED PRN AS NEEDED. RECENTLY HAS BEEN CHANGED EVERY SEVEN TO TEN DAYS. SIZE CUSTOMIZED FOR 7.5 ID CUFFLESS. 93 MM LENGTH.
ON 1/95 PT BEGAN TO HAVE GASTRIC PROBLEM, DIAHRREA AND WEIGHT LOSS. SPENT THOUSANDS OF DOLLARS ON STANDARD TESTS AND THEN AN MRI OF BREAST IMPLANTS REVEALED BOTH HAD A RUPTURE. SHE HAS LOST 20 LBS, HAS TROUBLE SLEEPING AND DEVELOPED A SENSITIVITY TO WHEAT GLUTENS AND EXCESS SUGAR IN DIET. TESTS REVEALED MANY VIRAL AND BACTERIAL PATHOGENS IN BLOOD. IMPLANTS WITH SILICONE ARE KNOWN TO CAUSE MALABSORPTION OF FATS. RPTR'S BODY LET DOWN AFTER CONTENDING WITH THESE DEVICES FOR 20 YEARS.
BIL BREAST AUGMENTATION 4/26/85. FORMATION BAKER'S GRADE III CAPSULAR CONTRACTURE ON RIGHT BAKER'S GRADE II ON LEFT WITH INCREASING PAIN AND DISCOMFORT. 4/26/96 SMALL MASS BELOW RIGHT NIPPLE. 5/20/96 PT UNDERWENT BIL REMOVAL OF GEL IMPLANTS, RIGHT BREAST B4, BIL CAPSULECTOMIES AND BIL BREAST AUGMENTATION WITH SALINE IMPLANTS. RIGHT BREAST INTACT AT TIME OF REMOVAL, LEFT IMPLANT WAS RUPTURED.
SURGEON CANNULATED LEFT SUBCLAVIAN VEIN ON FIRST ATTEMPT. GUIDE WIRE PLACED AND ADVANCED WITHOUT DIFFICULTY. WITH A SCALPEL, SURGEON MADE ENTRY A LITTLE LARGER. SMALL DILATOR THEN ATTEMPTED TO BE INSERTED. THE END FRAYED. ATTEMPTED TO INSERT LARGER DILATOR AND THE END ALSO FRAYED. THE DILATORS AND GUIDE WIRE WERE DISCONTINUED INTACT.
PT BEING FLUID RESUSCITATED, 30 UNITS OVER TWO HRS, GOOD ECG, BUT NO ECG ALARMS. NO ECG HEART RATE. NO ALARMS, DESPITE EXCELLENTLY DISPLAYED ECG. NUMEROUS OCCURRENCES OF THIS PROBLEM.
MONITOR SUDDENLY GOES STRAIGHT LINE. ECG AND PRESSURE WAVEFORMS. REPLACEMENT MODULE WORKS APPROPRIATELY. LEAVE MODULE TO SIT FOR 10 MINS THEN IT WORKS. ONGOING PROBLEM. NO ALARMS, ETC WITH THIS MALFUNCTION. NUMEROUS INCIDENTS.
MULTIPLE ALARM PARAMETERS HAVE ABILITY TO SET PRIORITY. INVASIVE PRESSURE ALARMS ONLY HIGH PRIORITY - OVERRIDE OTHER ALARMS. INABILITY TO TAILOR ALARM TO PT/STAFF NEEDS.
MONITOR ALARMS DISPLAYED AT OTHER BEDSIDES. NO MECHANISM TO PRIORITIZE DISPLAYED "ALARM WATCH" ALARMS. ONLY INDICATION OF ADDITIONAL ALARMS, SMALL PRINTING ON SCREEN. NO SCROLLING OF ALARMS. CLINICIANS DO NOT GET PRESENTED WITH ALARM INFO.
SVC DOCUMENTATION INCOMPLETE AND INACCURATE. VENDOR SVC REP INSTALLS NEW SOFTWARE. PREVIOUSLY INSTALLED SOFTWARE CUSTOMIZED TO CLINICIANS REQUIREMENTS. VENDOR DOCUMENTATION INCOMPLETE, DOES NOT DOCUMENT CHECKING OR REPROGRAMMING. CLINICIAN SOFTWARE CONFIGURATION.
VENDOR INSTALLED NEW SOFTWARE, DID NOT PROGRAM CORRECTLY TO MEET CLINICAL NEED. CLINICIAN UNABLE TO DISPLAY WAVEFORM. CORRECTED BY INHOUSE TECH STAFF.
TWO ANCHORS WERE INSERTED INTO GLENOID DURING SURGERY (REPAIR CAPSULAR JOINT). SUTURE EYELETS SNAPPED OFF ON INSERTION. SAME OCCURRENCE WITH 4 OF 5 PACKAGES WITHIN BOX OF 5. TWO ADDITIONAL ANCHORS WERE FINALLY INSERTED WITHOUT INCIDENT, AND GLENOID WAS REATTACHED. NO ADVERSE OUTCOME TO PT.
BALLOON BROKEN, NEW GASTROSTOMY TUBE HAD TO BE INSERTED.
BREAKAGE OF A CATH 3 WEEKS AFTER INSERTION. 8 INCHES OF CATH (TIP OUTWARD) REMOVED UNDER FLUOROSCOPY; POINT OF BREAKAGE ON FLUORO APPEARS TO BE WHERE CATHETER WENT UNDER CLAVICLE.
PUNCTURE NOTED THROUGH BLACK STOPPER AFTER REMOVING PROTECTIVE SEAL, NO OTHER BOTTLES IN LOT HAVE THIS PROBLEM. MFR NOTIFIED.
TRANSFER SET OF COMPOUNDER DEFECTIVE. WHEN ATTEMPTING TO REMOVE THE BAG FROM THE COMPOUNDER, THE WHITE PLASTIC PIECE AT THE JUNCTION OF THE TRANSFER SET BROKE OFF RENDERING THE TRANSFER SET USELESS SINCE IT BROKE THE SEAL, LEAVING THE SET OPEN TO CONTAMINATION.
AT THE COMPLETION OF TRIGGER POINT INJECTION PROCEDURE, THE NEEDLE WAS REMOVED FROM THE INJECITON SITE AND WAS NOTED TO BE BROKEN FROM NEEDLE HUB. PT ADMITTED AND HAD SURGERY FOR "INCISION AND REMOVAL OF METALLIC FOREIGN BODY IN THE RIGHT HIP AREA."
WIFE OF PT BROUGHT IN AN INSULIN SYRINGE WHICH HER HUSBAND DISCOVERED WHEN HE OPENED A BAG OF (10) TEN LOW DOSE INSULIN SYRINGES. THE NEEDLE OF THIS PARTICULAR SYRINGE APPEARS TO BE BENT AND STICKING THROUGH THE ORANGE SAFETY CAP. APPARENTLY NO OTHER SYRINGES WERE AFFECTED.
ON 11/27/95, A PRESSURE VALVE WAS PLACED INTO THE PT'S EXISTING LUMBOPERITONEAL SHUNT SYSTEM IN ORDER TO KEEP THE FLOW OF CEREBRAL SPINAL FLUID (CSF) REGULATED AT A NORMAL LEVEL. ON 12/13/95, THE PRESSURE VALVE WAS REPLACED DUE TO ASSUMED LEAK. ON INSPECTION OF THE VALVE AFTER REMOVAL, A PORTION OF THE SILICONE HAD SEPARATED FROM THE YELLOW RING CAUSING A LEAK.
BROKEN DENTAL IMPLANT. PT FRACTURED TITANIUM METAL IMPLANT AS A SINGLE TOOTH REPLACEMENT.
WOUND DRAIN BROKE AT INSERTION SITE DURING PHYSICIAN'S REMOVAL. REQUIRED RETURN TO SURGERY. USE OF LOCAL ANESTHETIC AND CONSCIOUS SEDATION. INVOLVED ENLARGEMENT OF DRAIN SITE INCISION.
THE CATHETER SHEARED OFF A FEW CM FROM THE ORIGIN IN THE LEFT SUBCLAVIAN VEIN, IMMEDIATELY DISTAL TO THE CLAVICLE. THE FRAGMENT OF CATHETER WAS IN PT'S RIGHT ATRIUM. FRAGMENT REMOVED VIA RIGHT GROIN INCISION. CATH REMOVED ON LEFT. REINSERTION, NEW CATH WITH DIFFERENT TIP.
BOTH IMPLANTS WERE RUPTURED. HAS HAD MULTIPLE MEDICAL PROBLEMS. HAS HAD TO TAKE EARLY RETIREMENT.
THE TUBING ATTACHED TO THE VENTED SPIKE ADAPTER SEPARATES FROM THE HARD PLASTIC, SOLUTION THEREFORE SPILLS OUT. VENTED BALL GETS STUCK. SOLUTION  SPILLS OUT INTO THE ENVIRONMENT THROUGH THE VENTED OPENING. REPORTED PROBLEM TO MFR.
MAMMARY IMPLANT PLACED 4/5/96. REVISION RECONSTRUCTION RIGHT BREAST. 5/20/96 RIGHT BREAST SOFT AND WRINKLING. POTENTIAL DEFLATION OF IMPLANT 25%. 5/22/96 RIGHT BREAST IMPLANT EXCHANGED.
PT HAS BEEN RECEIVING TPN INFUSION DAILY AT NIGHT SINCE 4/4/96. THERE WAS AN APPARENT PUMP DYSFUNCTION ON 5/11 AND 5/12 AND TPN BAGS DID NOT INFUSE FOR 2 DAYS. THE PT NOTIFIED RPTR ON 5/13 AND A DIFFERENT TPN PUMP WAS DELIVERED TO THE PT.
INTRACORONARY STENT WAS DEPLOYED IN RCA. IN ATTEMPTING TO RE-ESTABLISH WIRE POSITION, WIRE BECAME TANGLED IN STENT AND BROKE OFF DURING MD'S ATTEMPT TO REMOVE IT. SEGMENT OF WIRE REMAINS COILED IN STENT WITH A SEGMENT HANGING INTO THE ARTERY.
PT HAD A PORT IMPLANTED ON 5/22/96. APPROX TWO HRS AFTER INITIAL X-RAY, DIFFICULTY ACCESSING PORT NOTED. RADIOLOGIC FILM TAKEN SHOWED KINKING OR COMPRESSION OF THE LEFT SUBCLAVIAN VENOUS CATHETER. PT TAKEN BACK TO SURGERY FOR REMOVAL OF PORT. UPON INITIAL INSERTION OF THE PORT, PLACEMENT WAS APPROPRIATE PER C-ARM AND CATHETER FLUSHED FREELY.
GLASS/PLASTIC PORTION OF DISTAL TIP LOOSENED FROM TIP AND WAS NOTED IN THE KNEE AS SEEN ON TV MONITOR BY SURGEON. THIS WAS SUCTIONED INTO SPECIMEN CATCHER AND RETRIEVED BY CIRCULATING NURSE.
THE STAPLE GUNS DO NOT CLOSE THE SKIN. THEY JUST MAKE A TENT SHAPE. ALL ARE THE SAME LOT #, ONE PKG HASN'T BEEN USED, WAS PULLED BECAUSE SAME LOT #. ALL HAVE SAME EXP DATE.
THE LATEST EVENT WAS RPTR IS A NURSE IN AN UROLOGY OFFICE WITH A KNOWN LATEX ALLERGY. TREATED WITH STEROIDS 90% OF THE TIME OVER THE LAST YEAR FOR HAND ECZEMA AND URTICARIA. LAST PREDNISONE WAS 5/1/96 FOR SEVERE URTICARIA. TAKING ATARAX WITH NO RELIEF. THEN OUT OF WORK FOR 5 DAYS. PLACE OF EMPLOYER REMOVED ALL LATEX GLOVES WITH POWDER. REPLACED WITH POWDER FREE. RPTR HAS NOT USED LATEX GLOVES FOR 2 1/2 YRS.
BILATERAL SILICONE MAMMARY IMPLANTED 8 YEARS AGO. 2/96 SLIPPED AT CHIROPRACTER'S OFFICE. EXPERIENCED SORENESS RIGHT BREAST, IMPRESSION SLIGHT FULLNESS PALPABLE CONTRACTURE RIGHT BREAST. 5/96 IMPLANTS REMOVED BILATERAL, IMPLANTS FULLY INTACT.
PENILE IMPLANTS WERE PRESENT ABOUT 15 YEARS. A VALVE IN ONE IMPLANT FAILED, REQUIRING REPLACEMENT. THE IMPLANT WAS VERY OLD, AND FAILURE APPARENTLY NO UNEXPECTED.
PT WAS BEING TRANSFERED FROM BED TO W/C BY LIFT. PT SLIPPED OUT OF SLING AND FELL TO FLOOR. SLING TURNED ITSELF INSIDE OUT AFTER FALL. LOCK BAR LOOSENED.
INTRODUCER SHEATH SPLIT AS IT WAS BEING INSERTED INTO VESSEL.
END OF RECTAL TUBE IS NOT CUT EVENY OR SMOOTHLY. PTS FEAR INJURY TO RECTUM. CONTACTED CO 8/95, RETURNED PRODUCT 10/95. SECOND PT'S DATE OF BIRTH 12/28/00, WEIGHT 150.
RPTR COMPLAINS OF: CHRONIC INFECTIONS, INTESTINAL CYSTITIS, BLOOD PRESSURE PROBLEMS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, OTHER NEUROPATHY, CARPAL TUNNEL SYNDROME, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS,PROCRASTINATION, GETTING LOST OR CONFUSED, DEMENTIA, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ATYPICAL M-S, STROKE, REDUCED BLOOD FLOW TO BRAIN, BLACK OUT, PASSED OUT, UNCONSCIOUS, CHEST PAIN AND/OR BURNING SENSATION, INFLAMMATION, NERVE DAMAGE TO EYES, RAPID DETERIORATION OF EYES, DRY EYES AND UNKNOWN VISION LOSS, HORMONAL IMBALANCE DISORDER, CHRONIC SWELLING OF EXTREMITIES, CHRONIC PAIN IN EXTREMITIES, CHRONIC DISCOLORATION OF EXTREMITIES, HEAT OR COLD SENSITIVITY IN EXTREMITIES, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME, MOTOR DYSFUNCTION, BLEEDING, DISCHARGE, INFECTIONS - GYN, OVARIAN PROBLEMS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, FREQUENT MIGRAINES/SEVERE HEADACHES, HEART PAIN AND IRREGULAR FUNCTION, HYPERSENSITIVITY TO CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, LUPUS, ATYPICAL LUPUS, INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, LIVER INFLAMMATION/HEPATITIS A,B,C. ASTHMA, BLEEDING IN BOTH NOSTRILS, SHORTNESS OF BREATH, CAN'T BREATH, NEVER SMOKED, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS, CHEST, NIPPLE, BIKINI AREA, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN AND BURNING, MUSCLE ATROPHY, FIBROMYALGIA, MYOSITIS OR POLYMYOSITIS, FASCITIS, PARTIAL PARALYSIS, NUMBNESS, TINGLING, 1/2 BODY PARALYZED, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, DERMATOMYOSITIS, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, BLEEDING EASILY AND BRUISING, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICANOMAS, CLUMSINESS/DROPPING THINGS, MISJUDGING DISTANCE/RUNNING INTO OBJECTS, AND SICCA.
RPTR COMPLAINS OF: CHRONIC INFECTIONS, INTESTINAL CYSTITIS, BLOOD PRESSURE PROBLEMS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, OTHER NEUROPATHY, CARPAL TUNNEL SYNDROME, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, PROCRASTINATION, GETTING LOST OR CONFUSED, DEMENTIA, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ATYPICAL M-S, STROKE, REDUCED BLOOD FLOW TO BRAIN, BLACK OUT, PASSED OUT, UNCONCIOUS, CHEST PAIN AND/OR BURNING SENSATION, INFLAMMATION, NERVE DAMAGE TO EYES, RAPID DETERIORATION OF EYES, DRY EYES AND UNKNOWN VISION LOSS, HORMONAL IMBALANCE DISORDER, CHRONIC SWELLING OF EXTREMITIES, CHRONIC PAIN IN EXTREMITIES, CHRONIC DISCOLORATION OF EXTREMITIES, HEAT OR COLD SENSITIVITY IN EXTREMITIES, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, ESOPHAGITIS, DUODENITIS &/OR GASTRITIS, IRRITABLE BOWEL SYNDROME, MOTOR DYSFUNCTION, BLEEDING, DISCHARGE, INFECTIONS - GYN, OVARIAN PROBLEMS, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, FREQUENT MIGRAINES/SEVERE HEADACHES, HEART PAIN AND IRREGULAR FUNCTION, HYPERSENSITIVITY TO CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, LUPUS, ATYPICAL LUPUS, INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, LIVER INFLAMMATION/HEPATITIS A,B,C. ASTHMA, BLEEDING IN BOTH NOSTRILS, SHORTNESS OF BREATH, CAN'T BREATH, NEVER SMOKED, CHRONIC SWOLLEN LYMPH NODES UNDER ARMS, CHEST, NIPPLE, BIKINI AREA, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN AND BURNING, MUSCLE ATROPHY, FIBROMYALGIA, MYOSITIS OR POLYMYOSITIS, FASCITIS, PARTIAL PARALYSIS, NUMBNESS, TINGLING, 1/2 BODY PARALYZED, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, DERMATOMYOSITIS, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, BLEEDING EASILY AND BRUISING, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPPING THINGS, MISJUDGING DISTANCE/RUNNING INTO OBJECTS, AND SICCA.
BREAST IMPLANT PROBLEMS. RPTR IS VERY ILL FROM THESE BREAST IMPLANTS. SHE FEEL LIKE THERE IS NOWHERE TO TURN. SHE WANTS TO GET THEM OUT. HER OWN HEALTH INSURANCE REFUSES TO PAY FOR ANY OF IT. "SHE WAS TERMINATED FROM MY JOB, I HAVEN'T BEEN ABLE TO WORK FOR THE LAST TWO YEARS. I'M IN THE PROCESS NOW OF TRYING TO GET SOCIAL SECURITY. I NOW REALIZE WITH ALL OF MY HEALTH PROBLEMS I PROBABLY WILL NEVER WORK AGAIN." RPTR FEELS, THESE BREAST IMPLANTS COULD END UP COSTING LIVES. THIS IS JUST TOO BIG OF A DEAL TO EVEN PUT A PRICE TAG ON. THERE ARE TIMES WHEN RPTR FEELS LIKE JUST TAKING A KNIFE AND CUTTING THEM OUT HERSELF. OF COURSE SHE KNOWS THAT WOULD NOT BE TOO SMART. SHE IS JUST SO DESPERATE SHE DKOESN'T KNOW WHAT TO DO ANYMORE. WHEN EVERYDAY IS LIKE A STRUGGLE TO GET THROUGH DUE TO ALL OF HER ILLNESSES. SHE FEELS LIKE SHE DOESN'T HAVE ANY KIND OF LIFE AFTER WHAT MFR HAS DONE TO HER.
SILICONE BREAST IMPLANT RUPTURED REQUIRING SURGERY TO REMOVE THE IMPLANT. SURGERY PERFORMED ON 5/24/96.
THE FINGER TIPS OF THE GLOVES WERE STUCK TOGETHER.
UNABLE TO FLUSH A-LINES AFTER DRAWING LABS. PT HAD SURGICAL INTERVENTION TO REMOVE CLOT.
UNABLE TO OBTAIN WAVEFORM FOR INVASIVE PRESSURE ON DEVICE. MACHINE NOT PREVIOUSLY USED FOR THIS PURPOSE. RPTR IS TRYING TO VERIFY IF DEVICE WAS PURCHASED WITH THIS CAPABILITY. MACHINE NOT PREVIOUSLY USED. GI BLEED. TRANSPORT OF PT TO ANOTHER FACILITY.
PT HAD A RESPIRATORY ARREST SOON AFTER RECEIVING THE LOADING DOSE OF 0.6MG DILAUDID FROM A PCA PUMP. LATER DISCOVERED RN HAD MISTAKENLY ENTERED INCORRECT CONCENTRATION OF THE MEDICATION.
APPROX 40 SECS AFTER INITIATION OF PHACO EMULSIFICATION, THE TIP STOPPED ASPIRATING AND WITHIN A SECOND, CORNEA WHITENING AND WOUND BURN OCCURRED AT SITE OF INCISION. DEVICE WAS ASSEMBLED, TESTED, AND CALIBRATED IN REQUIRED FASHION. HANDPIECE WAS SENT TO MFR FOR EVALUATION. UNIT WAS ALSO SENT IN FOR EVALUATION.
THIRTEEN Y/O FEMALE HAD A APPENDECTOMY ON 5/7/96 FOR RUPTURED APPENDICITIS WITH PERITONITIS. A #7 DRAIN WAS PLACED AND SECURED TO THE SKIN WITH 3-0 SUTURE. ON 5/13/96, THE SURGEON REMOVED THE DRAIN AND NOTICED THE TIP OF THE DRAINAGE CATHETER WAS NOT PRESENT. AN X-RAY OF THE LOWER ABDOMEN SHOWED THE FOREIGN BODY. PT REQUIRED ADD'L SURGICAL PROCEDURE TO REMOVE THE END OF THE DRAINAGE CATHETER.
IMPLANTS PLACED IN 1985. RECENT MRI SHOWS RUPTURED IMPLANT. AT TIME OF SURGERY LEFT IMPLANT RUPTURED AND RIGHT IMPLANT INTACT. NO IDENTIFYING MARKS FOUND AT TIME OF PATHOLOGY REVIEW.
SEVERAL PROBLEMS HAVE BEEN ENCOUNTERED WITH THE TRAY INCLUDING: TRAY CONTAINED A BAD NEEDLE (NEEDLE WAS NOT SMOOTH). TRAY CONTAINED T-CONNECTOR THAT CRACKED AT THE HUB WHICH CAUSED A BACK-UP OF BLOOD.
PT SUSTAINED FIRST AND SECOND DEGREE BURNS TO SHOULDER DURING MRI SCANNING.
PT HAD A RIGHT MASTECTOMY, FOR CA WITH RECONSTRUCTION IN 2/96. APPROX 10 DAYS POST-OP, IT WAS NOTICED SHE HAD MALPOSITION OF THE IMPLANT AND SOME DEFLATION. ON 3/6/96, SHE RETURNED TO OR FOR REMOVAL OF THE FAILED IMPLANT WITH REPLACEMENT WITH A NEW TISSUE EXPANDER.
TWENTY-THREE-YEAR-OLD WOMAN HAD AN ANAPHYLACTIC RESPONSE WITHIN SECONDS WHEN PIC LINE INSERTED. SYMPTOMS INCLUDE HYPOTENSION, TACHYCARDIA, DIMINISHED LEVEL OF CONSCIOUSNESS. PT WAS TREATED WITH BENADRYL AND O2. (PIC REMOVED IMMEDIATELY).
PT WITH DIALYSIS CATHETER COULD NOT BE DIALYZED THROUGH CATHETER. PHYSICIAN CONCERNED THAT CATHETER WAS COLLAPSING. CATHETER REMOVED AND REPLACED 2/9/96.
WOUND DRAIN SEPARATED AT THE JUNCTION BETWEEN THE TUBING AND THE PERFORATED PORTION WHILE BEING REMOVED FROM PT. (*)
HOME HEALTH RN WAS REMOVING A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC LINE) FROM PT'S RIGHT ARM. LINE WAS REMOVED AT WHICH TIME IT WAS NOTED THAT THE CATHETER HAD BROKEN, LEAVING APPROX 3CM REMAINING IN PT'S ARM. LINE WAS ORIGINALLY PROVIDED AND INSERTED BY OUTSIDE CONTRACTOR.
LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH USE OF STAPLE GUN. PT RETURNED TO SURGERY DUE TO POSTOPERATIVE BLEEDING OF UTERINE ARTERIES. AFTER RETURNING TO OR, BLEEDING NOTED FROM MALFORMED AND PARTIALLY DISRUPTED STAPLE LINES.
LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY; BLEEDING THEN MALFUNCTION OF STAPLER. UPON ENTRANCE INTO ABDOMEN, THE STAPLER WAS OPENED AND IN ATTEMPTING TO PUT IT IN PLACE, IT WOULD NOT CLOSE. BLEEDING CONTINUED AND SURGEON ELECTED TO OPEN ABDOMEN TO COMPLETE PROCEDURE.
BLADE CUT BUT STAPLES DID NOT EJECT AND/OR CLOSE PROPERLY WHEN EJECTED. ACTIVELY PUMPING UTERINE VESSELS DISCOVERD TO BE BLEEDING PROFUSELY. EXPLORATORY LAPAROTOMY DONE WITH SUTURE LIGATION OF LACERATED VESSELS. UROLOGIST CALLED IN EMERGENTLY TO PERFORM CYSTOSCOPY DUE SLIGHTLY PINK URINE. NORMAL BLADDER MUCOSA NOTED.
AT 6:OOPM STAFF NURSE HEARD RESIDENT YELLING. UPON ENTERING BATHROOM, RESIDENT WAS ON THE FLOOR. WHILE CNA WAS TRANSFERRING RESIDENT, RESIDENT FELL ON TO HER LEFT HIP WHEN THE W/C BRAKES, WHILE ENGAGED, GAVE WAY AND THE CHAIR WENT OUT FROM UNDER THE RESIDENT. MOVEMENT OF HIP CAUSED ACUTE PAIN, LEFT LEG WAS ROTATED INWARD. DR AND FAMILY WERE CALLED. RESIDENT WAS TRANSFERRED TO HOSP.
INITIAL PERFORATION RESULTED IN "PLUNGE" INJURY TO BRAIN, DESPITE CHECKING PERFORATION PER MFR'S INSTRUCTIONS.
ANOTHER DEFIB WAS BROUGHT INTO THE PT'S ROOM. THE PADS WERE NOT CHANGED. THE ANALYZE/CHARGE SEQUENCE WAS AGAIN FOLLOWED (200 JOULES) AND AT "DISCHARGE" THERE WAS AGAIN NO APPARENT CHANGE IN THE PT'S CONDITION.
PT WAS IDENTIFIED AS BEING IN V-FIB VIA NURSE STATION AND OVERHEAD MONITOR. DEFIBRILLATOR WAS PLUGGED INTO WALL ELECTRICAL UNIT AND PADS WERE APPLIED. THE ANALYZE/CHARGE SEQUENCE WAS FOLLOWED (200 JOULES) AND AFTER PUSHING THE DISCHARGE BUTTONS THERE WAS NO APPARENT CHANGE IN THE OVERBED MONITOR RHYTHM OR IN PT ACTIVITY. THE NURSE AGAIN WENT THROUGH THE ANALYZE/CHARGE SEQUENCE (200 JOULES) AND PRESSED THE DISCHARGE BUTTONS WITH NO DISCERNIBLE OUTCOME.
FIBER TIP DEFECTIVE: LIGHT HEATED METAL TUBE APPROX .5 TO 1 CM FROM TIP (THIS WAS BEING USED DURING AN ARTHROSCOPY). AS A RESULT, THE PT'S CONDITION SURFACE WAS BURNED SUPERFICIALLY.
AMINOPHYLLINE WAS ORDERED TO RUN AT 7ML/HR. MEDICATION WAS HUNG AT 1500 AT 1830 PT WAS FOUND WITH APPROX 50 CC LEFT OUT OF 200CC BAG. PT WAS INFUSED AT APPROX 9ML/HR. INFUSION PUMP WAS SET AND LOCKED AT 7ML/HR. PT EXPERIENCED NAUSEA AND VOMITING.
AT 1900 AMINOPHYLLINE WAS STARTED PER DR'S ORDERS. PT WAS TO BE INFUSED AT 25MG/HR. AT 2100, PT WAS FOUND WITH THE AMINOPHYLLINE BAG EMPTY. THERE WERE 200 MG.S IN BAG TO START INFUSION. PT WAS THEREFORE INFUSED AT 100 MG/HR. PT DID NOT EXHIBIT ANY SIGNS OF DISTRESS.
PT SUSTAINED BURN TO LOWER LIP FROM NICK ON CORD OF BOVIE PENCIL CAUSING WIRE TO BE EXPOSED.
PROTOTYPE BUTTON FOUND TO BE ENTRAPPED IN GASTRIC WALL. VIA EFID, BUTTON BASE DISLODGED FROM WALL, TURNED 1/4. WILL MONITOR ON AN OUTPATIENT BASIS. THIS DEVICE WAS NOT IMPLANTED AT THIS FACILITY.
RESPONSE 1: THE REPORT INDICATES THAT THE EVENT WAS ATTRIBUTABLE TO USER ERROR. THE DEVICE FUNCTIONED PROPERLY. NO TESTING WAS WARRANTED. FURTHERMORE, NO SAMPLE WAS RECEIVED FOR ANALYSIS. RESPONSE 2: THE CUSTOMER ATTRIBUTED THE EVENT TO USER ERROR. THE CUSTOMER ASKED THAT COLOR CODING OF INTRAVENOUS AND OXYGEN TUBING BE CONSIDERED.
THE DECEASED WAS AN 83-YR-OLD WHITE MALE WHO DIED OF GAS EMBOLISM WHICH RESULTED FROM HIS OXYGEN TUBING BEING CONNECTED TO HIS INTRAVENOUS LINE. PT WAS ADMITTED FOR HEMATURICY. HAD A PROCEDURE, AND FOUND DEAD AFTERWARD WITH OXYGEN CONNECTED TO IV.
PT RECEIVING PAIN MEDICATION VIA EPIDURAL CATHETER THROUGH INFUSION PUMP. PT CALLED AGENCY TO NOTIFY THAT IV BAG WAS EMPTY AND PUMP WAS NOT FUNCTIONING PROPERLY. NURSE SENT OUT TO REPROGRAM AND INVESTIGATE PUMP. NURSE NOTED SCREENS WITH JUMBLED SYMBOLS AND WOULD NOT PROGRAM PROPERLY. PUMP RETURNED TO PHARMACY FOR REPLACEMENT PUMP. PT HAD NO C/O ADVERSE DRUG REACTION OR SIGNS/SYMPTOMS OF DRUG TOXICITY.
PT RECEIVING INFUSION FOR PAIN MANAGEMENT. VIA EPIDURAL CATHETER WITH CONNECTION TO INFUSION PUMP. PUMP DID NOT INFUSE SOLUTION, ONLY 10CC OF PAIN MED INFUSED. PT DID NOT RECEIVE PAIN MED AS ORDERED FOR 5 DAYS. PUMP CHANGED AFTER VISIT WITH PHYSICIAN. NO TESTS OR LABS PERFORMED. PT DID NOT EXPERIENCE ADVERSE REACTIONS TO SITUATION.
TIP OF EPIDURAL CATH REMAINED IN PT'S BACK WHEN CATH REMOVED AT DELIVERY OF BABY. X-RAYS CONFIRMED PIECE REMAINED IN PT.
AN ELECTROSURGICAL UNIT HAD FAILED TWICE DURING A SURGICAL PROCEDURE. FIRST FAILURE OCCURRED ON EVENING OF 5/8/96 HOWEVER, SURGERY STAFF REPLACED THE DISPERSIVE PAD AND UNIT WORKED AS DESIGNED. SAME UNIT WAS USED IN MORNING OF 5/9/96 AND IT FAILED A SECOND TIME. THIS TIME IT WAS REPLACED WITH ANOTHER ELECTROSURGICAL UNIT, IT APPEARED THAT SECOND UNIT DID NOT WORK, HOWEVER, DISPERSIVE PAD WAS REPLACED AND UNIT WORKED AS DESIGNED. WHEN THE BIOMEDICAL SVS TECH WAS INFORMED OF THIS OCCURRENCE, ELECTRO-SURGICAL UNIT WAS REMOVED FROM USE AND TAKEN FOR TESTING. UNIT WAS TESTED FOR CALIBRATED OUTPUT USING AN ELECTROSURGICAL UNIT ANALYZER. ALL OUTPUTS WERE VERIFIED TO BE WITHIN MFR SPECS, +/- 15% OF MEASURED OUTPUT. INTERNAL VISUAL INSPECTION REVEALED NORMAL CONDITIONS OF CIRCUIT BOARDS AND CABLE CONNECTIONS. THE BIOMEDICAL SVC TECH COULD NOT DUPLICATE FAILURE AND ELECTROSURGICAL UNIT WAS RETURNED TO SURGERY DEPT FOR USE. LATER IN AFTERNOON ON 5/9/96 UNIT WAS USED DURING AN EMERGENCY SURGERY PROCEDURE, AND UNIT FAILED A THIRD TIME. IT IS UNKNOWN WHETHER ANY ALARMS OR LIGHTS SIGNALLED A SPECIFIC FAILURE. THE SURGERY DEPT MGR STATED THAT "WE HAVE HAD PROBLEMS FOR LAST TWO WEEKS DUE TO HANDPIECE CONTROLS BEING USED." BIOMEDICAL SVS TECH STATED THAT "ON 4/30/96, BMSI RECEIVED UPGRADE KITS FOR FOUR ELECTROSURGICAL UNITS AND INSTALLED THEM. WHEN BMSI HEARD THAT THIS UNIT FAILED AGAIN THEY CHECKED THE UNIT OUT VISUALLY. BMSI COULD SEE NO EVIDENCE OF SHORTS, EG, BURNED WIRES, SINGED INSULATION, ETC. ALL ELECTRICAL AND MECHANICAL CONNECTIONS LOOKED AS THEY HAD EARLIER THAT DAY." THE BIOMEDICAL SVS TECH LEFT ELECTROSURGICAL UNIT IN SURGERY DEPT, INTENDING TO REMOVE IT NEXT DAY. IT WAS HIS UNDERSTANDING WITH SURGERY STAFF THAT UNIT WOULD BE MARKED SO THAT IT WOULD NOT BE USED, AND/OR A "NEEDS REPAIR" NOTICE WOULD BE POSTED. ON MORNING OF 5/10/96 BIOMED SVS TECH WENT TO PICK UP ELECTROSURGICAL UNIT FROM SURGERY DEPT AND FOUND UNIT TO BE IN USE. EVIDENTLY NO FAILURES WERE EXPERIENCED DURING PROCEDURE. UNIT WAS THEN REMOVED FROM USE BY BIOMED SVS TECH AND RETURNED TO BIOMEDICAL SVS SHOP FOR FURTHER TESTING. UNIT WAS TESTED WITH AN ELECTROSURGICAL ANALYZER AND PWEO OUTPUTS WERE VERIFIED TO BE WITHIN MFR SPECS. NEXT TEST INCLUDED USING ELECTROSURGICAL UNIT ON A PIECE OF RAW BEEF AND SET AT SAME SETTING IT WAS SET TO WHEN IT FAILED, 30 WATTS ON PURE CUT MODE. DURING THIS TEST THERE WAS INTERMITTENT EPISODES OF FAILURE, NO OUTPUT POWER TO HAND CONTROL TIP. DURING THIS FAILURE THERE WAS NO VISUAL OR AUDIBLE ALARMS. THE MFR SALES REP WAS CONSULTED, AND HE VERIFIED THIS FAILURE. HE RECOMMENDED RETURNING UNIT FOR EVALUATION. A LOANER UNIT WILL BE PROVIDED FOR USE DURING THIS TIME. THERE ARE TWO ESU'S USED IN DEPT. OTHER UNIT WAS ALSO TESTED AND IT DIDN'T FAIL. MFR'S QUALITY ENGINEER WAS CONTACTED, AND AS OF 5/20/96 THERE HAS BEEN NO RESPONSE.
JOHNSON & JOHNSON MEDICAL, INC. WEST QUEEN ST, SOUTHINGTON, CT 06489. THE USER FACILITY DID NOT PROVIDE A SAMPLE FOR ANALYSIS. THE MEDWATCH REPORT RECEIVED FROM THE FACILITY INDICATED THAT NO SAMPLE WAS AVAILABLE. NO LOT NUMBER IDENTIFICATION WAS PROVIDED TO ALLOW FOR ANALYSIS OF MFG RETAIN SAMPLES. THE USER FACILITY WAS UNABLE TO PROVIDE ADD'L INFO. IT HAS BEEN OUR EXPERIENCE THAT THE APPEARANCE OF FLASH IN AN INTRAVENOUS CATHETER MAY BE AFFECTED BY SEVERAL CLINICAL FACTORS. FOR EXAMPLE, ADULT PTS MAY PRESENT WITH LARGE, EASILY VISUALIZED VEINS WHICH HAVE IN FACT UNDERGONE SCLEROTIC CHANGES. SCLEROSED VEINS WILL IMPEDE VENOUS CIRCULATION AND MAY RESULT IN FLASHBACK THAT IS SO DIMINISHED THAT IT CANNOT BE USED AS A INDICATOR OF CORRECT PLACEMENT WITIN THE VEIN LUMEN. ALSO, CERTAIN THIN WALLED VEINS MAY NOT PROVIDE SUFFICIENT FLASH FOR THE USER TO CONFIRM ENTRY. THE REPORTED EVENT IS NOT OCCURRING AT GREATER THAN USUAL FREQUENCY BECAUSE THE NUMBER OF COMPLAINTS REPORTED FOR NO FLASHBACK INVOLVING THE PROTECTIV I.V. CATHETER OVER THE 12 MONTHS PRECEEDING THE ALERT DATE SHOW, USING REGRESSION ANALYSIS, A DOWNWARD SLOPE (T-RATIO = -1.61, >-2.0), ALTHOUGH IT IS NOT STATISTICALLY SIGNIFICANT (P VALUE = 0.139, >0.05). THE REPORTED EVENT IS NOT OCCURRING AT A GREATER THAN USUAL SEVERITY BECAUSE THE OUTCOME HAS BEEN LIMITED TO REMOVAL OF THE DEVICE WITH A SUCCESSFUL RESTART IN A DIFFERENT LOCATION.
EXTREME DIFFICULTY REMOVING PICC GUIDE WIRE. PICC INSERTED RIGHT MEDIAL CEPHALIC VEIN TO SVC. UNABLE TO REMOVE GUIDE WIRE. PT SENT TO X-RAY WITH WIRE IN PLACE. REMOVED 1 1/2 HRS LATER WITH HELP. WHITE GRIP AT END OF WIRE ALSO SLIPPED OFF DURING EFFORT. THIS REPORT REPRESENTS TWO PROBLEMS ENCOUNTERED WITH THIS DEVICE (GUIDE WIRE DIFFICULTY, HUB SLIPPING OFF). ADDITIONALLY, THIS OCCURRENCE IS ONE OF SEVERAL SIMILAR PROBLEMS HOSP HAS EXPERIENCED WITH THIS CO'S PRODUCTS.
TRADE COMPLAINT PERTAINING TO COMPETITOR ALLEGEDLY SHIPPING INVESTIGATIONAL USE INTRAOCULAR LENS (IOL'S) TO FOREIGN COUNTRIES FOR COMMERCIAL SALE. COMPLAINANT HAD ONE BOX OF IOL'S LABELED AS INVESTIGATIONAL USE FROM COMPETITOR, WHICH HE STATES WAS OBTAINED FROM A FOREIGN COUNTRY.
THE SYRINGE HAS NO GRADUATIONS OR MARKINGS AT ALL.
ADDED 10ML BACTERIOSTATIC SODIUM CHLORIDE THROUGH A PIN TO THE VIAL. UPON VISUAL INSPECTION RPTR NOTICED A FOREIGN BODY APPROXIMATELY 0.2 CM IN WIDTH. UPON DRAWING UP THE SODIUM CHLORIDE, NO FOREIGN BODY WAS NOTICED. THE RPTR DOES NOT KNOW IF THE FOREIGN BODY CAME FROM THE SPIKE OF THE PIN.
IN MID-FEBRUARY, SURGERY TECHS NOTED 4-5 SURGICAL LUMBAR PTS WITH SKIN REACTIONS FOLLOWING USE OF CERTAIN FOAM HEADRESTS, WHICH ARE PART OF A PRE-PACKAGED SURGICAL KIT. OVER THE PREVIOUS 2-3 WEEKS, TECHS HAD NOTICED THAT THE NEWER HEADRESTS WERE NOT THE ORIGINAL COLOR. THE COLOR HAD GRADUALLY BEEN CHANGING FROM PALE PINK TO DEEP FUSCHIA. THE SKIN REACTIONS WERE NOTED TO OCCUR ONLY WITH THE DARKER HEADRESTS. THE DARKER THE COLOR, THE MORE SEVERE THE REACTION. THE SALES REP WAS NOTIFIED BY PHONE ON 2/14/96 OF THE PROBLEM AND ASKED TO PICK-UP ALL FUSCHIA HEADRESTS AND REPLACE THEM WITH THE ORIGINAL PINK ONE. THE PTS WITH SKIN REACTIONS WERE ASSESSED IN THE OR, IN PACU AND AGAIN IN THEIR ROOMS. ALL THE RASHES APPEARED TO BE RESOLVING WITHOUT TREATMENT, SO NO OTHER FOLLOW-UP WAS DONE UNIL 3/6/96; WHEN THE SURGEON FOR THE REFERENCED PT REPORTED THAT THE PT'S RASH HAD DEEPENED. HE REFERRED THE PT TO A DERMATOLOGIST FOR ADD'L TREATMENT.
PT WAS RESIDENT OF NURSING HOME AND WAS BEING TREATED AT A DIALYSIS CENTER. DURING TREATMENT PT HAD CHEST PAIN AND WAS SENT TO THE ER AND ADMITTED. ORDERS INCLUDED TO START TUBE FEEDING PER PEG TUBE. TUBE WAS WITHOUT IDENTIFYING. MARKINGS WAS ACTUALLY A TENKOFF CATHETER. TUBE WAS USED FOR THE TUBE FEEDING. LATER TUBE WAS SURGICALLY REMOVED; AND PT HAD ASCITES AND INTRA-ABDOMINAL INFECTION. POSSIBILITY OF SEPSIS PRESENT AT TIME OF ADMISSION.
THE PT WAS PREPARED FOR A UGI IN RADIOLOGY. THE PT STOOD ON THE PLATFORM OR FOOTSTOOL OF THE X-RAY TABLE AND THE PLATFORM GAVE WAY CAUSING THE PT TO FALL. A SUBSEQUENT INVESTIGATION FOUND THAT THE LOCK ON THE FOOTSTOOL HAD BEEN BENT, CAUSE UNKNOWN.
PT DIALYZED WITHOUT INCIDENT UNTIL LAST 5-10 MINS. WHEN DIALYZER CLOTTED TREATMENT WAS DISCONTINUED AND PT DISCHARGED TO NSG HOME. SHE WAS LATER SENT TO THE HOSP WHERE HEMOLYSIS WAS IDENTIFIED. PT DIED ON 3/7/96.
PT DIALYZED FOR 2 HRS AND 45 MINS WHEN SHE DEVELOPED STOMACH CRAMPS. PT RINSED BACK AND WENT TO RESTROOM. VAGINAL BLEEDING NOTED. PT HAD HYSTERECTOMY 7 YEARS AGO. HCT DROPPED FROM 33 TO 25%. PT SENT TO HOSP, HEMALYSIS IDENTIFIED. SHE WAS TRANSFUSED.
PT UNDERGOING HEMODIALYSIS TREATMENT EXPERIENCED EPIGASTRIC PAIN AND DISCOMFORT AT END OF 3.5 HR TREATMENT. BLOOD PRESSURE ALSO ELEVATED TO 222/125. PORCANTIC 10 MGS SL GIVEN. PT DISCHARGED TO HOME. LATER THAT EVENING PT ADMITTED TO THE HOSP WITH HEMOLYSIS. PT ALSO EXPERIENCED PANCREATITIS WHILE HOSPITALIZED.
PT DIALYZED ON 4/13/96. NO COMPLAINTS WERE OFFERED. LATER THAT DAY THE PT WENT TO THE ER WITH GI COMPLAINTS. HEMOLYSIS WAS IDENTIFIED.
PT DEVELOPED NAUSEA AND VAGUE GI COMPLAINTS DURING HEMODIALYSIS TREATMENT. TREATED WITH PHENERGAN 12.5 MGS IV. DISCHARGED TO HOME. PT LATER PRESENTED AT HOSP. HEMOLYSIS WAS IDENTIFIED.
PT DIALYZED FOR 3 HRS. HE WAS COMPLAINING OF ABDOMINAL PAIN PRE, DURING AND POST TREATMENT. STATED IT FELT AS THOUGH FOOD NOT BEING FULLY SWALLOWED. VOMITED POST-TREATMENT. PT LATER PRESENTED AT ER AND HEMOLYSIS FOUND.
IMMEDIATELY FOLLOWING PHACO EMULSIFICATION OF CATARACT SMALL AREA OF OPACITY NOTED NEAR INCISION.
HAD PT POSITIONED ON OR BED. FOOT OF BED RAISED, NO ONE KNEW THE CONTROLS. THERE WAS NO APPARENT INJURY BUT BED HAD TO BE UNPLUGGED BEFORE ACTION WOULD STOP. REPAIRMAN CAME IN AND WORKED ON BED.
TUBING HAS SIGNIFICANT AMOUNT OF AIR IN IT AFTER PRIMING. NO OTHER PTS HAVE REPORTED THIS PROBLEM. MAY BE DRUG RELATED, PT RECEIVING PIPRACILLIN.
HUBER NEEDLE WINGS BECAME DETACHED COMPLETELY FROM NEEDLE AND TUBING. RN REPLACED (RE-ACCESSED) PORT WITH ANOTHER NEEDLE.
THE LOWER RUBBER INJECTION PORT POPPED OFF OF THE PRIMARY TUBING. THE PT'S ANTIBIOTIC WAS NOT GIVEN COMPLETELY AND THE PT ALSO "EXSANGUINATED" AN UNKNOWN AMOUNT (WAS REAL LIGHT, SO PROBABLY MOSTLY IV ANTIBIOTIC FLUID).
ADULT ICU DRUG LIST DELETED FROM FIVE (5) PUMPS IN ICU #3. NO IDENTIFIABLE CAUSE WAS FOUND FOR THE DELETION.
NEUROPHYSIOLOGICAL MONITORING NEEDLE BROKEN OFF WHILE IN PT. REQUIRED SURGICAL REMOVAL OF NEEDLE UNDER LOCAL ANESTHESIA.
TWO COLONOSCOPIES SCHEDULED. DID FIRST PROCEDURE "DISTAL COLONOSCOPY" TO APPROX 35 CM ONLY. DURING CLEANING AND "LEAK TEST PROCEDURE" THE SCOPE WAS FOUND TO HAVE THE LEAK IN THE DISTAL TIP. HAD TO HAVE CURRIER OUT A REPLACEMENT SCOPE FOR THE 2ND PROCEDURE.
THE IUD WAS IMPLANTED IN 11/95. IN JUNE RPTR TOOK A HOME PREGNANCY TEST AND IT WAS POSITIVE. SHE WENT TO THE DR AND TOOK ANOTHER PREGNANCY TEST AND IT WAS ALSO POSITIVE. THEY REMOVED THE IUD.
WHILE IMPLANTING THE VALVE IN THE OR, A FORCEPS CAME INTO CONTACT WITH THE VALVE WITH SOME INTENSITY AND RESULTED IN BREAKAGE OF THE DISK. THE VALVE HAD TO BE REMOVED AND A NEW ONE INSERTED. THE PT DID NOT EXPERIENCE ANY HARM.
CLIP APPLIER JAMMED AND FAILED TO WORK AFTER ONLY ONE CLIP APPLIED. PROCEDURE: LUMPECTOMY. DEVICE TO BE RETURNED FOR EVALUATION.
CLIP APPLIER JAMMED TOWARD END OF CLIP CARTRIDGE DURING LUMPECTOMY. DEVICE TO BE RETURNED FOR EVALUATION.
DURING GASTRECTOMY STAPLER WAS PLACED AROUND TISSUE AND STAPLE CARTRIDGE POPPED LOOSE AND WOULD NOT LOCK IN PLACE. DEVICE TO BE RETURNED FOR EVALUATION.
THERAPIST OBSERVED, VIA IN ROOM MONITOR, A 2MM SHIFT IN COUCH VERTICAL DISTANCE UP WHEN MAKING A LONGITUDINAL ADJUSTMENT. VERTICAL THUMB WHEEL NOT TOUCHED. ELECTRONIC'S TECH: WHEN DROPPED COUCH SKIRT, NOTICED THAT WHENEVER LATERAL, LONGITUDE, OR COUCH ROTATION WERE DRIVEN A SLIGHT MOVEMENT ON VERTICAL DRIVE MOTOR OCCURRED. SET LONGITUDINAL TABLE TOP FULL OUT, SET COUCH VERTICAL ON 110CM ON MONITOR, DROVE COUCH IN AND COUCH RAISED UP, WITHOUT VERTICAL ACTIVATION.
THREE (3) UNITS WERE PURCHASED FROM CO. OF THE 3 UNITS, 2 BECAME LOOSE AT THE BASE WHERE THE CHROME TUBE IS JOINED TO THE MOBILE BASE. THE 2 BASES WERE REPLACED BY THE SALES REP. IN THE MEANTIME, THE OTHER BASE BECAME LOOSE. (*) (LABEL)
PINHOLE LEAK IN PRODUCT TUBING NOTICED DURING INFUSION OF IVI6.
SILICONE MAMMARY IMPLANTS (BILATERAL) WERE REMOVED AND REPLACED WITH SALINE IMPLANTS AT PT'S REQUEST. SILICONE MAMMARY IMPLANTS APPEARED TO BE FULLY INTACT UPON REMOVAL.
DURING AN ENDOSCOPIC HERNIA REPAIR, A METAL PIECE ON THE DISTAL END OF THE STAPLE DEVICE FELL OFF. NO ONE WOULD HAVE REALIZED THIS HAD HAPPENED IF IT WEREN'T FOR THE FACT THAT IT WAS VISUALIZED ON THE TV MONITOR DURING THE PROCEDURE. THE PIECE WAS REMOVED IN ITS ENTIRETY THROUGH THE SCOPE DURING THE SURGERY.
STENT WAS PLACED AFTER DILATION OF MALIGNANT ESOPHAGEAL STRICTURE IN MID ESOPHAGUS. AFTER THE STENT PLACEMENT, PT STARTED COMPLAINING OF CHEST PAIN AND PAIN CONTINUED UNTIL SHE WAS ADMITTED TO HOSP ON 5/24/96. DURING THIS PERIOD SHE DEVELOPED HOARSENESS, COUGH AND SHORTNESS OF BREATH. CAT SCAN AND BARIUM SWALLOW REVEALED ESOPHAGO-TRACHEAL FISTULA SECONDARY TO THE EROSION OF OPEN END WIRED IN THE PROXIMAL CUP OF THE STENT. PT ALSO HAD MEDIASTINITIS AND WAS TREATED WITH ANTIBIOTICS. LATER SHE WAS TRANSFERRED WHERE SHE UNDERWENT BRONCHOSCOPY AND ESOPHAGOSCOPY AND HAD WIRES OF THE STENT ERODING THE LUMEN WERE VISUALIZED.
ATTEMPTED TO PLACE STENT. FAILED TO DEPLOY.
RPTR WAS FILLING THE PUMP WITH 100 ML OF DRUG/FLUID. WHEN RPTR WAS DONE, BEFORE RPTR COULD LUER-LOCK THE SYRINGE OFF OF THE PUMP, THE SYRINGE STARTED FILLING BACK UP. RPTR COULD NOT MAKE THE MEDICATION STAY IN THE PUMP WITHOUT BACKING UP INTO THE SYRINGE SINCE THERE WAS 100ML IN THE PUMP. RPTR WAS USING A 60ML SYRINGE. THERE WAS A BIG MESS BECAUSE THE EXCESS 40 ML OR SO SPEWED ALL OVER THE CLEAN ROOM AND HERSELF.
PT WITH MULTIPLE MEDICAL PROBLEMS WHO HAD RECURRENT MASSIVE ASCITES DESPITE MAXIMAL MEDICAL TREATMENT. HAD A PERITONEAL VENOUS SHUNT PLACED ON 7/19/95, BUT EXPERIENCED PROBLEMS WITH IT NOT WORKING EFFECTIVELY. THE SHUNT WAS CLEANED AND REPOSITIONED (ADHESIONS AND CLOT NOTED) ON 3/28/96 WITH IMMEDIATE RELIEF. HOWEVER, IN MAY THE PT AGAIN HAD PROBLEMS WITH ASCITES INCREASING, SO ON 5/17/96 THE SURGEON PLACED A SECOND SHUNT. AGAIN, THE SURGEON FELT THIS WAS NOT A DEVICE PROBLEM AS SUCH, BUT MORE A PROBLEM DUE TO THE PT'S MULTIPLE MEDICAL CONDITIONS.
DURING SURGICAL PROCEDURE, LIGHT SLEEVE FELL OFF OF SURGICAL LIGHT WHEN TOUCHED TO ADJUST THE LIGHT. SLEEVE FELL INTO STERILE FIELD. APPEARS TO FIT LOOSELY ON LIGHT HANDLE. THESE ARE TWO OF THE FOUR OCCURRENCES OF THIS PROBLEM RPTR HAS HAD IN THE PAST TWO WEEKS. SLEEVE AVAILABLE FOR INSPECTION.
FRACTURED WIRE DURING PTCA AND CORONARY STENT PROCEDURE 5/22/96. DISSECTION OF PROX LAD. CATH LAB RN NOT AWARE TILL FILM REVIEWED NEXT DAY. THEREFORE WIRE NOT SAVED, CONTAMINATED AND DISCARDED. INFORMED CARDIOVASCULAR SURGEON. PT TO OR FOR CABG. WIRE NOT REMOVED IN SURGERY, BYPASS GRAFT DONE. PT EXPIRED 5/26 IN CRITCARE UNIT POST CABG. PT JEHOVAH'S WITNESS AND REFUSED BLOOD TRANSFUSION AND EXPIRED POST SURGERY. NO AUTOPSY AND WIRETIP NOT RECOVERED.
RPTR EXPERIENCED PAIN WHICH RADIATED FROM HER HIP DOWN TO HER ANKLE. THIS SITUATION MADE HER UNABLE TO WALK. AS SHE STATED "(IT) FEELS LOOSE AND I HAVE TO WAIT UNTIL (IT) IS ATTACHED SO I CAN WALK."
PT DEVELOPED DYSPNEA, STABBING CHEST PAIN AND BRIGHT RED FLUSHING IMMEDIATELY AFTER PLACEMENT OF CATHETER. CATHETER REMOVED AND PT BECAME ASYMPTOMATIC. CATHETER BEING PLACED FOR IV FLUIDS IN PT WITH HYPEREMESIS.
CATHETER DISCONNECTED FROM CATH RESERVOIR. MIGRATED INTO RIGHT ATRIUM AND VENTRICLE. WAS RETRIEVED WITHOUT DIFFICULTY.
RPTR COMPLAINS OF: CARPAL TUNNEL SYNDROME, ANXIETY &/OR DEPRESSION, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, BASAL CELL CARCINOMA, PAIN &/OR BURNING SENSATION IN CHEST, ELEVATED CHOLESTEROL OR TRIGLICERIDES, CHRONIC SWELLING OF EXTREMITIES, HEAT OR COLD SENSITIVE EXTREMITIES, CONSTIPATION, HYSTERECTOMY, HYPERSENSITIVITY TO MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, CONNECTIVE TISSUE DISEASE, UNEXPLAINED RASHES, SUN SENSITIVITY, NUMEROUS MOLES, FRECKLES, ETC, CHRONIC FATIGUE SYNDROME AND LONG-TERM EXTREME FATIGUE. RPTR ALSO C/O HARDENING AND SCAR TISSUE. THE SPECIMENS ONE AND TWO LABELED LEFT IMPLANT AND RIGHT IMPLANT RESPECTIVELY SHOW SIMILAR GROSS FEATURES WITH BOTH IMPLANTS BEING RUPTURED WITH A GELATINOUS TRANSLUCENT YELLOW STICKY MATERIAL EXTRUDING FROM THE THIN TRANSPARENT IMPLANT CAPSULE AND CONFORMING TO THE CONTOUR OF THE SPECIMEN CONTAINER BOTH OF WHICH MEASURE 9.0 CM IN DIAMETER X APPROX 3.0 CM IN DEPTH. NO MFR MARKINGS ARE IDENTIFIED ON THE DETACHED OUTER IMPLANT MEMBRANE. SECTIONS FROM THE LEFT AND RIGHT CAPSULES SHOW SIMILAR HISTOLOGIC FEATURES OF DENSE SCLEROTIC FIBROUS TISSUE WITH ENTRAPPED SCATTERED FOAMY HISTIOCYTES AND MINERALIZED MATERIAL ADHERENT TO THE INNER CAPSULAR SURFACE. ADDITIONALLY, THE LEFT CAPSULE SHOWS FRAGMENTS OF SYNTHETIC MESH WITH SURROUNDING REACTIVE FOREIGN BODY GIANT CELLS. (*)
RPTR C/O : CHRONIC URINARY INFECTIONS, BLOOD PRESSURE PROBLEMS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, OTHER NEUROPATHY, CARPAL TUNNEL SYNDROME, MOTOR NEURON DISEASE, CHRONIC MYALGIC ENCEPHALITIS, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ORGANIC BRAIN SYNDROME, REDUCED BLOOD FLOW TO BRAIN, SEIZURES, CHEST &/OR BURNING SENSATION IN CHEST, INFLAMMATION OF CHEST, ELEVATED CHOLESTEROL OR TRIGLICERIDES, NERVE DAMAGE, DRY EYES: FEELING OF GLASS SPLINTERS IN EYES. ADRENAL PROBLEMS, CHRONIC SWELLING OF EXTREMITIES, CHRONIC DISCOLORATION (RED OR BLUE), HEAT OR COLD SENSITIVITY OF EXTREMITIES, RAYNAUD'S DISEASE, FREQUENT LOW GRADE FEVER, IRRITABLE BOWEL SYNDROME, HYSTERECTOMY, LOSS OF SEXUAL DESIRE BEFORE MENOPAUSE, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, FREQUENT MIGRAINES/SEVERE HEADACHES, PALPITATIONS, HYPERSENSITIVITY TO CHEMICALS, MOLDS, DUST OR POLLEN, FOOD, CONNECTIVE TISSUE DISEASE, LUPUS, SJOGREN'S SYNDROME, INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, CONSTANT COUGH, NIGHT SWEATS, ALL SYMPTOMS OF TB BUT NEGATIVE X-RAYS. CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, MYOSITIS OR POLYMYOSITIS, FASCITIS, CONSTANT BUT RANDOM MUSCLE FLUTTERS, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY, UNEXPLAINED RASHES, SUN SENSITIVE, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPPING THINGS, MISJUDGING DISTANCE/RUNNING INTO OBJECTS, SICCA. BLOOD SERUM SPECIMEN SHOWED THE PRESENCE OF AUTOANTIBODIES. SPECIFICALLY, THE SERUM WAS STRONGLY POSITIVE TO CONNECTIVE TISSUE MOLECULES. IN THE SAME SERUM SAMPLE WE DETECTED A WEAK POSITIVE REACTION FOR AN AUTOANTIBODY TO BRAIN TISSUE PROTEINS. MOREOVER, THE SERUM TESTED POSITIVE FOR ANTI NUCLEAR ANTIBODIES MOLECULES USING IMMUNO FLUORESCENT DETERMINATIONS. RECENTLY, IT WAS REPORTED THAT PTS WITH AUTOIMMUNE DISEASE SYMPTOMS AND CENTRAL NERVOUS SYSTEM MANIFESTATIONS SHOWED SIMILAR SERUM REACTIVITY. THESE RESULTS SUGGEST THAT RPTR'S IMMUNE SYSTEM HAS MOUNTED AN ANTIBODY REACTION AGAINST HER OWN TISSUES. THE TYPE OF AUTO-IMMUNE REACTIVITY DETECTED IS SIMILAR TO THAT FOUND IN THE SERA OF A LARGE NUMBER OF PTS WHOSE SILICONE GEL BREAST IMPLANTS ALLOWED SILICONE GEL PARTICLE TO MIGRATE INTO THE SURROUNDING TISSUES. (*)
RPTR C/O: CHRONIC URINARY INFECTIONS, BLOOD PRESSURE PROBLEMS, PERIPHERAL NEUROPATHY, DEMYELINATING NEUROPATHY, OTHER NEUROPATHY, CARPAL TUNNEL SYNDROME, MOTOR NEURON DISEASE, CHRONIC MYALGIC ENCEPHALITIS, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ORGANIC BRAIN SYNDROME, REDUCED BLOOD FLOW TO BRAIN, SEIZURES, CHEST &/OR BURNING SENSATION IN CHEST, INFLAMMATION OF CHEST, ELEVATED CHOLESTEROL OR TRIGLYCERIDES, NERVE DAMAGE, DRY EYES: FEELING OF GLASS SPLINTERS IN EYES, ADRENAL PROBLEMS, CHRONIC SWELLING OF EXTREMITIES, CHRONIC DISCOLORATION (RED OR BLUE), HEAT OR COLD SENSITIVITY OF EXTREMITIES, RAYNAUD'S DISEASE, FREQUENT LOW GRADE FEVER, IRRITABLE BOWEL SYNDROME, HYSTERECTOMY, LOSS OF SEXUAL DESIRE BEFORE MENOPAUSE, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATIONS, FREQUENT MIGRAINES/SEVERE HEADACHES, PALPITATIONS, HYPERSENSITIVITY TO CHEMICALS, MOLDS, DUST OR POLLEN, FOOD, CONNECTIVE TISSUE DISEASE, LUPUS, SJOGREN'S SYNDROME, INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, RHEUMATOID ARTHRITIS, PERSISTENT JOINT STIFFNESS, CONSTANT COUGH, NIGHT SWEATS, ALL SYMPTOMS OF TB BUT NEGATIVE X-RAYS, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, MYOSITIS OR POLYMYOSITIS, FASCITIS, CONSTANT BUT RANDOM MUSCLE FLUTTERS, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY, UNEXPLAINED RASHES, SUN SENSITIVE, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICANOMAS, CLUMSINESS/DROPPING THINGS, MISJUDGING DISTANCE/RUNNING INTO OBJECTS, SICCA. BLOOD SERUM SPECIMEN SHOWED THE PRESENCE OF AUTOANTIBODIES. SPECIFICALLY, THE SERUM WAS STRONGLY POSITIVE TO CONNECTIVE TISSUE MOLECULES. IN THE SAME SERUM SAMPLE WE DETECTED A WEAK POSITIVE REACTION FOR AN AUTOANTIBODY TO BRAIN TISSUE PROTEINS. MOREOVER, THE SERUM TESTED POSITIVE FOR ANTI NUCLEAR ANTIBODIES MOLECULES USING IMMUNO FLUORESCENT DETERMINATIONS. RECENTLY, IT WAS REPORTED THAT PTS WITH AUTOIMMUNE DISEASE SYMPTOMS AND CENTRAL NERVOUS SYSTEM MANIFESTATIONS SHOWED SIMILAR SERUM REACTIVITY. THESE RESULTS SUGGEST THAT RPTR'S IMMUNE SYSTEM HAS MOUNTED AN ANTIBODY REACTION AGAINST HER OWN TISSUES. THE TYPE OF AUTO-IMMUNE REACTIVITY DETECTED IS SIMILAR TO THAT FOUND IN THE SERA OF A LARGE NUMBER OF PTS WHOSE SILICONE GEL BREAST IMPLANTS ALLOWED SILICONE GEL PARTICLE TO MIGRATE INTO THE SURROUNDING TISSUES. (*)
THREE HOME OXYGEN PTS BECAME ILL DUE TO A FOUL, PLASTIC ODOR EMITTED FROM THE OXYGEN TUBING THEY WERE USING. HOME OXYGEN PTS WERE NAUSEATED, SICK, AND DIZZY FROM FOUL FUMES THEY WERE BREATHING WHILE USING THE OXYGEN. REPORTED PROBLEM TO MFR AND THEY WERE ALREADY AWARE OF THE PROBLEM. RPTR FEELS END USERS SHOULD HAVE BEEN NOTIFIED AND PRODUCT SHOULD HAVE BEEN RECALLED. ADD'L EVENT DATE 5/24/96, 2 FEMALES, 1 MALE PT.
PUMPS (11) READ SYSTEM ERROR 84 UPON INITIAL INJECTION OF PCA DOSE. THE SYSTEM ERROR SHUT DOWN THE PUMP AND ERASED THE MEMORY OF PROGRAMMING. THE BATTERY WAS REMOVED AND PUMP REPROGRAMMED AND SUBSEQUENT USE OF THE PUMP HAS NOT RESULTED IN THE REAPPEARANCE OF THE SYSTEM ERROR 84. THIS MALFUNCTION WAS DEMONSTRATED ON AT LEAST 11 DIFFERENT PUMPS.
THREE IV SETS - ALL REPORTED DEFECTIVE BY NURSING PERSONNEL. TWO BROKE APART AT THE FLASHBULB JUNCTION. UNSURE OF THE PROBLEM WITH THE THIRD SET.
11/14/95: 20 GAUGE IV STARTED IN LEFT FOREARM. DISCONTINUED ON 11/15/95; ENTIRE ARM UP TO ELBOW BRIGHT RED AND TENDER. 11/15/95: 22 GAUGE IV STARTED IN RIGHT FOREARM; ON 11/16/95 ENTIRE ARM ALSO UP TO ELBOW BRIGHT RED AND TENDER. 20 GAUGE POLYURETHANE IV STARTED WITH SAME THERAPY AND REMAINED ASYMPTOMATIC UNTIL DISCONTINUED ON 11/19/95. PT INFORMED OF ALLERGY TO VIALON CATHETER MATERIAL.
ADD'L INFO REC'D FROM RPTR 2/26/01: THERE WERE SEVERAL ADVERSE DRUG EVENTS. ON INSULIN AND MICRONASE.
FALSE NEGATIVE RESULT FROM TEST STRIP CAN SLIDE IN RAPID ASSAY HOUSING AND WILL REPORT A POSITIVE PT RESULT AS NEGATIVE. THE INCIDENT IS AT LEAST 1% DEFECTIVE AND POSSIBLY GREATER.
ON 3/5/96, 45-YR-OLD FEMALE PT HAD OPERATIVE HYSTEROSCOPY WITH ENDOMETRIAL ABLATION UNDER GENERAL ANESTHESIA. DURING PROCEDURE, THE TEFLON TIP ON OPERATIVE HYSTEROSCOPY SHEATH CAME OFF INSIDE PT'S UTERUS; TIP WAS FOUND IN PT'S VAGINA AFTER MULTIPLE EFFORTS TO REMOVE FROM UTERUS WITH FORCEPS, SHARP CURETTE AND SUCTION CURETTE. PROCEDURE WAS EXTENDED FOR 20-25 MINS PER ATTENDING SURGEON.
22 FRENCH REUSABLE CYCTOSCOPE FIRST USED TO EVALUATE PROSTATIC AND ANTERIOR URETHRA. URETHRA DILATED WITH SCOPE TO 28 AND 24 FRENCH RESECTOSCOPE SHEATH PLACED. AFTER 4-5 SWIPES DIFFICULTY WITH SHEATH AND HUB BECAME DISLODGED FROM SCOPE. REMOVED WITH KELLY FORCEPS WITH MINIMAL ABRASION TO URETHRA.
BROKEN PEDICLE SCREW IN SPINE. MOVING AROUND EVERY TIME RPTR MOVES. LAST X-RAY VERIFIED MOVEMENT. MAJOR PAIN, HARD TO GET AROUND.
AT 32 YRS OLD RPTR HAD HAD 5 BIOPSIES OF THE BREAST FOR CYSTS. WAS TOLD BECAUSE OF HER STRONG FAMILY HISTORY OF BREAST CANCER SHOULD HAVE A BI-LATERAL MASTECTOMY AND SILICONE GEL IMPLANTS. RPTR WAS TOLD NOTHING OF ANY RISKS BUT ONLY THE POSITIVE SIDE EG, SHE WOULD NEVER HAVE TO WORRY ABOUT CANCER AGAIN. RPTR HAD THE SURGERY(S) AND WAS SICK FOR 17 YEARS BEFORE SHE HAS A RUPTURE OF THE RIGHT IMPLANT. SHE HAD NO IDEA THAT THAT COULD HAPPEN. WHEN SHE HAS SURGERY TO EXPLANT THE IMPLANTS, THEY BOTH HAD RUPTURED AND SHE HAD A PULMONARY EMBOLISM AFTER SURGERY. WAS IN HOSP 10 DAYS AND IS NOW TOTALLY DISABLED FROM SLE. SHE CANNOT WALK WITHOUT A WALKER AND HAS COGNITIVE DYSFUNCTION.
PT RECEIVED SUPERFICIAL BURN TO LIP DURING ORAL SURGERY. DEVICE EVALUATED BY HOSP BIOMED AND MFR AND NO PROBLEMS FOUND. HOSP INVESTIGATING POSSIBLE USER ERROR.
PT WAS HAVING CORONARY STENT IMPLANTED. BALLOON MAXIMUM RECOMMENDED PRESSURE IS 8.0 ATM. WHEN BALLOON PRESSURE WAS INCREASED TO 7.0 ATM TO DILATE BALLOON AND DEPLOY STENT, BALLOON RUPTURED BETWEEN 6 AND 7 ATM. ANOTHER BALLOON WAS USED TO COMPLETE PROCEDURE. PT LATER REQUIRED CABG DUE TO CLOT AT STENT/ACUTE ARTERY CLOSURE THAT SAME DAY. NO APPARENT INJURY. NO INDICATION THAT SUBSEQUENT ARTERY CLOSURE/CABG WAS RELATED TO RUPTURE.
ULTRASONIC PROBE BROKE DURING PROCEDURE.
CAUTERY TIP CAUGHT FIRE WHILE BEING USED BY PHYSICIAN ON PT. NO APPARENT INJURY TO PT. SECOND OCCURRENCE WITH SAME PRODUCT ON 5/29/96.
20 GAUGE LUMEN PICC INSERTED IN RIGHT ANTECUBITAL ON 12/19/95. ON 1/10/96, LINE WAS BEING DISCONTINUED SLOWLY WITHOUT RESISTANCE. WITH 10 CM STILL IN PT, RN STOPPED AND WHILE REMOVING TAPE FROM CATHETER JUST ABOVE HUB, CATHETER BROKE OFF. IMMEDIATE STEPS TAKEN TO PREVENT BLEEDING OUT OR AIR INTO LINE AND THUS, NO UNTOWARD EFFECT TO PT.
PT PULLED MIDLINE CATHETER OUT DURING CONFUSED STATE. BUTTERFLY AND DRESSING INTACT ON PT'S ARM; CATHETER PULLED OUT THROUGH LOCKING MECHANISM ON BUTTERFLY. RN WHO INSERTED STATES LOCKING MECHANSIM WAS ACTIVATED.
PERIPHERAL LOCKING DEVICE. NOTE FROM NURSE "CAP DEFECTIVE, WILL NOT PIERCE."
VENTRICULAR PACING LEAD PLACED IN PT ON 5/1/96 AT 1620 FOR 3RD DEGREE HEART BLOCK. PT PACEMAKER DEPENDENT AND RHYTHM 100% PACED. PACING FAILED AT APPROX 2200. PT WENT ASYSTOLE. WAS RESUSCITATED PROMPTLY BUT WOULDN'T PACE. CONDUCTION TESTS IN VIVO SHOWED ELECTRICAL CONDUCTIVITY THROUGH LEAD. LEAD WAS REMOVED AND NEW ONE INSERTED WITH CAPTURE AT 100% PLACEMENT. LEAD WAS BLACK AND TIP APPEARED FRACTURED. WIRE WAS INSERTED THROUGH 5 LUMEN PACING PULMONARY ARTERY CATHETER AND ATTACHED TO EXTERNAL PACEMAKER.
RESIDENT FELL TO THE FLOOR DURING TRANSFER TO THE WHEELCHAIR FROM THE LIFT. THE LIFT TIPPED OVER DURING TRANSFER WHEN ATTEMPTING TO MANIPULATE RESIDENT'S BODY INTO CHAIR. LIFT BECAME OFF BALANCE. RESIDENT HIT HEAD, NECK AND BACK ON FLOOR. FOUND TO HAVE 1CM DEEP, 1 1/2 INCH LONG LACERATION TO RIGHT RING FINGER, WHICH WAS PULSATING WITH PROFUSE BLEEDING. FIRST AID GIVEN AND TRANSPORTED TO HOSP ER. BLEEDING STOPPED PRIOR TO TRANSFER. RESIDENT OBSERVED TO BE ALERT, SMILING AND LAUGHING.
PT IN RECOVERY NOTED TO HAVE SMALL 1/2 CM BURNS. UPON INVESTIGATION IT WAS BELIEVED LIGHT SOURCE MUST HAVE BURNED PT. DURING PHYSICIAN USE, 2 SMALL HOLES NOTED IN DRAPE, NO OTHER SOURCE IN BODY.
EPIDURAL CATHETER IN CATHETER TRAY WOULDN'T THREAD. ANOTHER CATHETER WAS PULLED FROM STOCK AND INSERTED. AFTER PT DELIVERED, CATHETER WAS PULLED BY CRNA AND A 2CM SECTION MISSING, APPEARS TO HAVE BEEN RETAINED IN THE PT.
WITHIN A YEAR OF IMPLANTATION, MANY PROBLEMS WENT ON. MAJOR ALLERGIES, POLLEN, FOOD, CHEMICAL, ENVIRONMENTAL, MEDICATIONS, PROBLEMS WITH CIRCULATION, ARTHRITIS, NUMBNESS, SLEEP PROBLEMS, ABDOMINAL PAIN, BODY RASHES, MUSCLE PAIN, FATIGUE, GALL BLADDER, LIVER RPOBLEMS, REFLUX, SHORT TERM MEMORY LOSS, ADDISON'S DISEASE, SWOLLEN LYMPH GLANDS, PAIN IN BREAST, DIARRHEA. PT BECAME TOO ILL TO WORK. CHRONIC FATIGUE; TOO WEAK TO DRIVE HER CAR. DR BILLS, MEDICAL BILLS USED UP ALL THEIR MONEY AND FAILED TO SOLVE THE PROBLEMS. IMPLANT RUPTURED. NO ONE REALIZED IT WAS THE IMPLANT LEAKING ITS POISON INTO HER SYSTEM. BLOOD TESTS SHOWED IMMUNE SYSTEM DYSFUNCTION.
ON 5/14/96 DURING BRONCHOSCOPY PROCEDURE A PORTION OF THE CATHETER BALLOON TORE OFF AS THE CATHETER WAS BEING REMOVED.
WHILE IN CATH LAB INTRA-AORTIC BALLOON WAS INSERTED VIA FEMORAL ARTERY. SEVERAL MINUTES LATER, BLOOD WAS NOTICED IN TUBING, INDICATING A LEAK AND BALLOON FAILURE. BALLOON WAS REMOVED AND A NEW ONE INSERTED WITHOUT INCIDENT.
DIALYSIS MACHINE WAS SET UP FOR THE PT. CONDUCTIVITY ON SCREEN WAS READING A NA# OF 140 WHICH IS THE USUAL SETTING. MACHINE GAVE THE INDICATION THAT THE CONDUCTIVITY WAS AS IT SHOULD BE. PT CAME AND WAS PUT ON THE MACHINE FOR DIALYSIS. PT BP WAS 200/90 PRIOR TO DIALYSIS. PROCARDIA GIVEN. BP REMAINED ELEVATED 213/94. PULSE 97. DR WAS NOTIFIED; PT VOMITING; DR ORDERED NIFEDIPINE 10MG. BP DECREASED TO 166/69, PULSE 97. NAUSEA, VOMITING IMPROVED. DR CAME IN PT WAS NON-RESPONSIVE, WOULD ANSWER HER NAME ONLY. TRANSFERRED TO ICU. BLOOD DRAWN. PT NA# WAS 117, VERY LOW. MACHINE CHECKED AND FOUND THAT CONDUCTIVITY NOT ACCURATE. NA# WAS MUCH LOWER THAN THE MACHINE SHOWED. PT RE-DIALYZED ON A DIFFERENT MACHINE. THE MACHINE TECHS REPORTED THE INCIDENT TO THE MFR AND THE MACHINE WAS SERVICED AND REPAIRED. A NEW POLICY OF CHECKING CONDUCTIVITY MANUALLY WITH A METER WAS INSTITUTED IMMEDIATELY. NO PT WILL RUN WITHOUT A MANUAL CHECK.
WOUND DRAIN BROKE AT INSERTION SITE DURING REMOVAL. REQUIRED RETURN TO SURGERY, USE OF LOCAL ANESTHETIC AND CONSCIOUS SEDATION. INVOLVED ENLARGMENT OF DRAIN SITE INCISION.
PUMP RESET BASAL RATE ON ITS OWN FROM 0.9 TO 0.5. POSSIBLY RELATED TO USE OF PORTABLE PHONE. PT HAD TO RETURN HER OTHER PUMP FOR OCCLUSION MALFUNCTION AND HAD NOT RECEIVED IT BACK NOW AFTER TWO MONTHS. BLOOD GLUCOSE DOUBLED TO 200'S FOR NO OTHER REASON. THOSE TWO DAYS 6/2 AND 6/3.
PT HAD LAVH PERFORMED 5/31/96, AT 0730 FOR POST-OP BLEEDING. UPON PERFORMING A LAPAROTOMY, THE SURGEON FOUND THE STAPLE CLIP LINE ON THE LEFT OVARIAN PEDICAL HAD PARTED AND PARTIALLY PARTED ON THE RIGHT SIDE. A LEFT SALPINGO-OOPHORECTOMY AND OVER-SEWING OF THE RIGHT OVARIAN ARTERY WAS PERFORMED. HCT 25.7, 3 UNITS OF BLOOD GIVEN.
THE USER FACILITY RETURNED THE ACTUAL PRODUCT SAMPLE FOR ANALYSIS. VISUAL EXAMINATION REVEALED BLOOD RESIDUE IN THE HUB AND TUBING. INSPECTION BY MICROSCOPY AND LEAKAGE TESTING WERE PERFORMED. THE SAMPLE WAS LEAK TESTED TO DETERMINE THE PRESENCE OF A CRACKED HUB. THE FOLLOWING TEST METHOD WAS USED: 45 LBS PSI OF WATER PRESSURE WAS FORCED THROUGH THE CATHETER HUB UNIT FOR A 10 SEC TIME PERIOD TO DETERMINE IF THERE WAS FLUID LEAKAGE BETWEEN THE CATHETER HUB AND THE TUBING ASSEMBLED TO IT. LEAKAGE IS DEFINED AS A FALLING DROP OF WATER. THE DEVICE WAS FOUND TO BE FREE OF CRACKS, HOLES OR LEAKAGE. TEN MFG RETAIN SAMPLES WERE ALSO TESTED IN THE SAME MANNER. ALL THE RETAIN SAMPLES WERE FOUND TO BE FREE OF CRACKS, HOLES AND LEAKAGE. THE INVESTIGATION CONCLUDED THAT THE REPORTED DIFFICULTY COULD NOT BE ATTRIBUTED TO THE DEVICE. ADD'L INFO WAS REQUESTED FROM THE USER FACILITY. THE HOSP REP REPORTS THAT THE CLINICIAN HAD REMOVED THE INTRODUCER NEEDLE AND HAD NOT YET CONNECTED THE HUB OF THE CATHETER TO ANOTHER DEVICE AT THE TIME THAT THE BACKFLOW WAS NOTED. ANY INTRAVENOUS CATHETER WILL EXHIBIT A BLACKFLOW OF BLOOD IF IT IS NOT MECHANICALLY OBTURATED. STANDARDS OF PRACTICE INDICATE THAT ALL CONNECTIONS SHOULD BE CHECKED FOR SECURITY AND LEAKAGE WHEN ESTABLISHING ANY INTRAVENOUS FLUID PATHWAY. THE REPORTED EVENT IS NOT OCCURRING AT GREATER THAN USUAL FREQUENCY BECAUSE THE NUMBER OF COMPLAINTS REPORTED FOR LEAKAGE INVOLVING THE PROTECTIV PLUS I.V. CATHETER OVER THE 12 MONTHS PRECEEDING THE ALERT DATE SHOW, USING REGRESSION ANALYSIS, AN UPWARD SLOPE, THOUGH NOT SUBSTANTIAL (T RATION = 1.73, <2.0) AND NOT STATISTICALLY SIGNIFICANT (P VALUE = 0.114, >0.05. THE REPORTED EVENT IS NOT OCCURRING AT GREATER THAN USUAL SEVERITY BECAUSE THE OUTCOME HAS BEEN LIMITED TO REMOVAL OF THE DEVICE WITH A SUCCESSFUL RESTART IN A DIFFERENT LOCATION.
DURING A PROCEDURE MUCOSAL BURNS WERE NOTED ON RIGHT UPPER LIP AND LOWER LIP. UPON EXAMINATION, A CRACK WAS FOUND ON THE PROTECTIVE COATING OF THE TONSIL TIP. SIMILAR BURNS HAVE BEEN REPORTED ON 3/28/94 AND 4/25/94 ON THIS SAME DEVICE.
AIR ENTERED INTO TUBING DURING A BLOOD TRANSFUSION. AIR WAS DESCRIBED AS ENTERING "HIGH AND MIDWAY UP" IN THE TUBING. AIR ENTERED INTO BLOOD BAG BUT WENT INTO PT. A SECOND TUBING OF SAME LOT HAD THE SAME PROBLEM. A THIRD TUBING OF A DIFFERENT LOT WORKED WELL. (LABEL)
IMMUNE RELATED DISORDERS, JOINT PAIN, FATIGUE, CHILLS, AND ARTHRITIS. PAIN AND HARDENING OF IMPLANTS, BREAST CANCER. HAD IMPLANTS PUT IN IN 1984. PROBLEMS STARTED 1993.
DURING INSERTION OF PICC LINE PT BECAME CYANOTIC, WITH COMPLAINTS OF FEELING LIKE SHE WAS GOING TO PASS OUT AND DYSPNEA. THE EPISODE HAPPENED VERY QUICKLY. INITIAL INSERTION WENT SMOOTHLY; THE CATHETER ADVANCED EASILY. THE PT HAD BEEN MEASURED FOR 18.5" TO BE INSERTED. SYMPTOMS OCCURRED IMMEDIATELY WHEN APPROX 18" HAD BEEN INSERTED. THE PICC WAS IMMEDIATELY DISCONTINUED. VITAL SIGNS AND O2 SATURATIONS WERE MONITORED; PT RECOVERED.
PT IN CHAIR WITH WRIST AND VEST RESTRAINTS ON. FOUND SITTING ON FLOOR; WRIST RESTRAINTS WERE POPPED OFF AND THE VEST RESTRAINT WAS ON BUT STRAPS HAD RIPPED. THE RESTRAINT THAT WAS USED ON THIS PT WAS NOT SAVED. SINCE THAT TIME, ANOTHER RESTRAINT WAS TORN IN A SIMILAR MANNER AND RPTR HAS THAT ONE. PT SUFFERED FRACTURED FEMUR.
BREAK IN CLOSED, STERILE CSF EXTERNAL DRAINAGE AND MONITORING (EDM) SYSTEM WAS APPARENT WHEN NURSE WAS EMPTYING FROM ONE RESERVOIR TO ANOTHER (RESERVOIR #1 TO #2), AND FLUID WAS OBSERVED LEAKING FROM RESERVOIR #1. THE EDM WAS NOT PATENT. A COMPLETE STERILE CHANGE OF SYSTEM WAS PERFORMED BY PHYSICIAN.
FINALLY, A REVIEW OF THE COMPLAINT DATABASE DID NOT UNCOVER ANY SIMILAR COMPLAINTS LOGGED AGAINST THE TWO LOTS IN QUESTION. CO'S FINDINGS, BOTH VISUAL AND FUNCTIONAL, SUGGESTS THAT UNDER NORMAL CONDITION OF USAGE THE PRODUCT SHOULD HAVE PERFORMED SATISFACTORILY WITH NO LEAKAGE. THIS IS CORROBORATED BY A LACK OF SIMILAR COMPLAINTS ON THE LOTS CITED IN THIS COMPLAINT. FINALLY WITH REGARD TO THE LEAKAGE, CO WOULD ADVISE THAT IT IS POSSIBLE FOR SYRINGES TO LEAK AT THE PLUNGER IF A SIDEWAYS FORCE IS APPLIED DURING COMPRESSION OF THE FLUID.
PT UNDERWENT SURGERY FOR A TORN ACL OF THE LEFT KNEE WITH TORN MEDIAL MENISCUS ON 5/23. DURING PROCEDURE, WHILE USING THE RING CURETTE FROM THE ARTHROSCOPY, THE TIP OF THE RING PORTION OF THE INSTRUMENT BROKE OFF IN THE PT'S LEFT KNEE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE TIP VIA ARTHROSCOPY BUT WAS UNSUCCESSFUL. THERE WAS NO ATTEMPT MADE TO PERFORM OPEN SURGERY TO THE KNEE.
PT WAS 5 DAYS STATUS POST OPEN PROSTATECTOMY. WHILE MD ATTEMPTED TO REMOVE DRAIN, THE DRAIN FRACTURED RESULTING IN RETAINED PORTION OF DRAIN REMAINING IN PT'S ABDOMEN, CONFIRMED BY KUB. THIS RESULTED IN PT'S RETURN TO SURGERY FOR REMOVAL OF RETAINED DRAIN SEGMENT AND WOUND EXPLORATION. THERE WAS NO SUTURE NOTED THROUGH THE DRAIN BY THE MD. THE DRAIN WAS WEDGED SECURELY BETWEEN 2 SUTURES. IT WAS CONCLUDED THAT THE PRESSURE USED TO REMOVE THE DRAIN WAS NOT ENOUGH TO CAUSE THE DRAIN TO FRACTURE; THEREFORE, THE POSSIBILITY OF A DEFECTIVE DRAIN COULD NOT BE RULED OUT.
THESE ITEMS CONTAIN FIBERGLASS-LIKE MATERIALS THAT GETS INTO THE NOSTRILS OF THE CAREGIVERS WHEN DONNED AND IS VERY IRRITATING. THESE ALSO HAVE SHORTER CHIN LENGTH WHICH MAKES THE MASK SLIP OFF THE FACE. COUPLED WITH THE LOOSE FIBERS IN THE MASK, THE WEARER GOES THROUGH AN UNCOMFORTABLE ORDEAL.
BOTH LOTS BROKE DURING PT USE. LOT # 6194B BROKE WHERE THE TUBE ENTERS THE NOSE WHILE ALREADY INSERTED. A NURSE WAS INJECTING FLUID WHEN IT BROKE AND WAS ABLE TO RETRIEVE THE INSERTED PART WITHOUT INCIDENT. LOT # 6193A BROKE NEAR THE END THAT'S EXPOSED, ALSO WHILE FLUID WAS BEING INJECTED. THIS TUBE WAS ALSO REPLACED WITHOUT INCIDENT. F/U DETERMINED THAT THE USER USED A 10 OZ 20CC SYRINGE. SMALLER VOLUME MEANS HIGHER PSI AND COULD ACCOUNT FOR THE BREAK ACCORDING TO THE DISTRIBUTOR'S COMPLAINT REVIEWER. A COPY OF COMPLAINT WAS FORWARDED BY DISTRIBUTOR TO MFR. NO ACTUAL SUSPECT UNITS ARE AVAILABLE, BUT SAMPLES FROM SOME LOT WERE REQUESTED BY THE DISTRIBUTOR.
THE BALLOON ON THE END OF THE CATHETER BREAKS UPON TESTING OF THE BALLOON RIGHT OUT OF THE PACKAGE. THIS HAPPENED TO FOUR OUT OF THIS LOT.
7/8/94, UNIT WAS BEING USED ON A PT. UNIT BEGAN SMOKING, THEN SHUT DOWN. THE UNIT WAS REMOVED FROM SVC AND SENT TO MFR ON 8/9/95. UNIT WAS REPAIRED UNDER WARRANTY AND RETURNED TO SVC ON 8/20/95. MFR DID NOT TELL RPTR WHAT WAS DONE TO REPAIR THE UNIT. 11/15/95, UNIT WAS BEING USED ON PT. AS HAPPENED ON PREVIOUS PROBLEM, UNIT BEGAN TO SMOKE, THEN SHUT DOWN. IT WAS REMOVED FROM SVC. THIS UNIT IS INOPERABLE, THE EXACT PROBLEM IS NOT KNOWN. IT IS UNSAFE FOR USE AND WILL NOT BE RETURNED FOR USE EVEN IF REPAIRED BY THE MFR. THE MFR WILL NOT ALLOW RPTR TO ACCESS ANY SVC OR TECHNICAL DATA. EQUIPMENT HAS PROVEN TO BE OF POOR QUALITY.
THIS MASK IS STOCKED ROUTINELY ON THE ANESTHESIA MDS CARTS. FOR THE LAST TWO MONTHS, THESE MASKS HAVE BEEN FOUND TO BE VERY STICKY WHEN TAKEN OUT OF THE PROTECTIVE WRAPPER. THE HARD PLASTIC PORTION OF THE MASK IS NORMAL BUT THE FACE CUSHION IS STICKY AND LEAVES A STICKY MATERIAL ON THE FACE AND HANDS WHEN IT COMES IN CONTACT WITH THESE SURFACES.
BREAST PROSTHESIS INSERTED DUE TO CARCINOMA OF THE BREAST WHICH RESULTED IN A RIGHT MASTECTOMY IN 5/93. IN 6/95 AN EXAM REVEALED A REDUCTION IN VOLUME OF TEH RIGHT BREAST. IT WAS DETERMINED THAT THERE WAS A PINHOLE RUPTURE NEAR THE VALVE SUPPORT MECHANISM. SPECIFICALLY, THE DEFECT WAS FOUND AT A WELD POINT NEAR THE PORT USED TO INSTILL THE SALINE.
THE RADIOLUCENT SLEEVE BROKE WHILE INSIDE A PT'S ABDOMEN DURING SURGERY. THE TROCAR AND SLEEVE WERE INSERTED IN NORMAL FASHION. NO DIFFICULTIES NOTED BY THE STAFF SURGEON ON INSERTION. THE SLEEVE WAS USED TO INSERT A GRASPER TO HOLD THE GALLBLADDER. VISIBLE PIECES FROM THE BROKEN SLEEVE WERE REMOVED FROM THE PATIENT'S ABDOMEN. THE SLEEVE AND FRAGMENTS WERE SHOWN TO THE SURGEON AND GIVEN TO THE CO'S REP FOR ANALYSIS AND REPORT TO THE FDA. ITEMS ON SHELF FROM SAME LOT NUMBER INSPECTED FOR CRACKS. NONE FOUND. ITEMS REMOVED FROM SHELF UNTIL CAUSE OF PROBLEM DETERMINED AND ITEM CLEARED FOR USE BY CO.
ON MARCH 7 AND AGAIN ON MARCH 8, WHILE ATTEMPTING TO DO AN EKG ON 2 SEPARATE PTS, THE PRINTOUT WAS A STRAIGHT LINE. ON BOTH OCCASIONS MEDICAL MAINTENANCE WAS CALLED TO CHECK OUT THE EKG MACHINE. THE MEDICAL MAINTENANCE TECH DETERMINED THAT THE PROBLEM WAS NOT THE EQUIPMENT, BUT THE ELECTRODES. THIS IS A MAJOR CONCERN AS ONE OF THESE PTS WAS A CHEST PAIN PT REQUIRING IMMEDIATE DIAGNOSING AND TREATMENT. TREATMENT NEEDED TO BE DETERMINED BY THE RESULTS OF AN EKG, THE MALFUNCTIONING OF THE ELECTRODES CAUSED A DELAY IN THE PT'S INITIAL TREATMENT AND SUBSEQUENT TRANSFER TO AN ER FOR DEFINITIVE TREATMENT.
PROBLEM WITH CARTRIDGE INJECTOR SPLITTING WHILE INSERTING INTRAOCULAR LENS INTO THE EYE. WHEN INJECTOR SPLITS IT CAUSES DAMAGE TO THE INTRAOCULAR LENS IMPLANTS ON SOME OCCASIONS.
THIS SUTURE IS NOT OF ADEQUATE QUALITY. THIS SUTURE FRAYS EASILY CAUSING PREMATURE BREAKAGE WHICH IN TURN CAUSES INCISION OPENING. THIS INCREASES THE NEED FOR ADD'L SURGERY TO REPAIR THE INCISION AND INCREASED INCIDENCE OF INFECTION.
RPTR STATED THAT A PT EXPIRED AFTER A SECOND FEEDING TUBE WAS PLACED AND BEFORE AN X-RAY WAS TAKEN TO ESTABLISH THE LOCATION OF THE TUBE. THE FIRST FEEDING TUBE WAS REMOVED AFTER THE X-RAY SHOWED A BRONCHIAL LOCATION.
FLASH FIRE FROM CLASS "D" OXYGEN CYLINDER WITH A SUSPECT REGULATOR. FIRE FIGHTER OPENED VALVE ON OXYGEN CYLINDER TO ADMINISTER OXYGEN TO PT DURING AN EMS CALL. FLASH FIRE IMMEDIATELY RESULTED CAUSING SUBSTANTIAL BURNS TO THE ARMS, CHEST, NECK AND FACE OF FIRE FIGHTER. NICKEL SIZE HOLE IN REGULATOR FOUND AFTER FLASH FIRE.
POLICE, EMS, FIRE FIGHTER RESPONDED TO A CALL FOR RESUSCITATION OF A 4-MONTH-OLD FEMALE INFANT IN CARDIOPULMONARY ARREST. CPR INITIATED BY POLICE OFFICER. FIRE FIGHTER TURNED ON O2 AT REQUEST OF EMS PERSON. O2 CYLINDER EXPLODED UPON OPENING AND THE GAUGE FLEW OFF. REGULATOR BODY BURNED THROUGH AROUND THE GAUGE WITH A NICKEL SIZE HOLE FOUND. 2 SUBSTANTIAL INJURIES FOLLOWED. POLICE OFFICER SUSTAINED 1ST AND 2ND DEGREE BURNS ON THE LEFT SIDE OF HIS FACE AND ARMS. ALSO HAD SHRAPNEL WOUNDS. FIRE FIGHTER SUSTAINED 2ND AND 3RD DEGREE BURNS ON HANDS AND FLASH BURN TO THE FACE. THE PARAMEDICS SUSTAINED SHRAPNEL WOUNDS AND TINNITUS FROM THE EXPLOSION. INFANT SUSTAINED NO INJURY FROM EVENT, HOWEVER, SHE LATER DIED (AUTOPSY STATED CAUSE OF DEATH WAS SIDS). DEVICE IS NOW IN THE OFFICE OF ARSON INVESTIGATION.
WITHIN 2 YEARS OF IMPLANTATION WITH SILICONE BREAST IMPLANTS, RPTR STARTED HAVING NERVE PROBLEMS, HEPATITIS B, SEIZURES AND ARTHRITIS. RPTR HAD ONE STILLBIRTH AND 2 MISCARRIAGES. SHE HAS ONE SURVIVING CHILD WHO HAS BRONCHITIS AND SUFFERS FROM LEARNING DISORDER. RPTR ALSO SUFFERS FROM BAD HEADACHES AND DIZZINESS ALL THE TIME. HER SYMPTOMS IMPROVED SOMEWHAT AFTER EXPLANTATION. RPTR WANTS TO BE COMPENSATED FOR HER SURGERY AND EXTENSIVE MEDICAL BILLS.
CATHETER WAS TESTED PRIOR TO PREPARING THE TRAY BEFORE THE PROCEDURE. IT INFLATED WITHOUT DIFFICULTIES. THE CATHETER WAS INSERTED IN THE COMMON FEMEROL VEIN. THE BALLOON WOULD NOT INFLATE. THE CATHETER WAS EXCHANGED AND PROCEDURE WAS COMPLETED WITHOUT INCIDENT.
RPTR COMPLAINS OF: NEUROPATHY, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ORGANIC BRAIN SYNDROME, THYROID PROBLEMS, "ANTIBODIES OVARIEST THYROID", RAYNAUD'S DISEASE, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, HYSTERECTOMY, OVARIES REMOVED, FREQUENT MIGRAINES/SEVERE HEADACHES, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS, MOLDS, DUST OR POLLEN, INSECT BITES OR STINGS, UNUSUAL CHRONIC INFECTIONS, CONNECTIVE TISSUE DISEASE, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY IN GROIN, LYMPH NODES REMOVED, 3 REMOVED FROM BOTH SIDES OF GROIN, UNEXPLAINED RASHES, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPPING THINGS, MISJUDGING DISTANCE/RUNNING INTO OBJECTS, AND SICCA. ALSO NUMBNESS, BILATERAL CAPSULAR CONTRACTURES WITH CLOSED CAPSULOTOMIES, RUPTURED IMPLANTS AND NUMBNESS.
WHEN CHECKING BALLOON OF CATHETER PRIOR TO INSERTING INTO PT, THE BALLOON WOULDN'T DEFLATE. A DIFFERENT CATHETER WAS USED.
TROCAR LEAKED, THEN CAME APART AND COULDN'T BE PUT BACK TOGETHER. SECOND TROCAR LEAKED AROUND RUBBER GASKET. WHEN THE SCISSORS WERE REMOVED A VERY LARGE AIR LEAK WAS NOTED AROUND THE GASKET.
SURGEON ATTEMPTED TO USE STAPLER. WOULD NOT RELEASE STAPLES. ANOTHER STAPLER USED WHICH FUNCTIONED WITH NO PROBLEMS. NO PT INJURY.
DEVELOPED AIRBORNE ALLERGY TO LATEX USING LATEX GLOVES AT WORK. NOW RPTR CANNOT BE IN THE SAME BLDG WHERE LATEX IS PRESENT WITHOUT GOING INTO ANAPHYLAXIS. (IE RESPIRATORY ARREST WITH ANGIOEDEMA, AND SEVERE FACIAL SWELLING). RPTR HAS BEEN TREATED IN ER APPROX 20 TIMES WITH VENTOLIN INHALER, SUB-Q EPINEPHRINE, AND IM/IV SOLUMEDROL, BENADRYL AND TAGAMET.
DEVELOPED AIRPORNE ALLERGY TO LATEX USING LATEX GLOVES AT WORK. NOW RPTR CANNOT BE IN THE SAME BLDG WHERE LATEX IS PRESENT WITHOUT GOING INTO ANAPHYLAXIS. (IE RESPIRATORY ARREST WITH ANGIOEDEMA, AND SEVERE FACIAL SWELLING). RPTR HAS BEEN TREATED IN ER APPROX 20 TIMES WITH VENTOLIN INHALER, SUB-Q EPINEPHRINE, AND IM/IV SOLUMEDROL, BENADRYL AND TAGAMET.
DRAGER, INC. CRITICAL CARE SYSTEMS, 4101 PLEASANT VALLEY RD, STE 100, CHANTILLY, VA 22021. THE DRAGER INC. COMPLAINT FILE DOES NOT HAVE ANY RECORDS WITH THIS PROBLEM. THE "OXYGEN BLENDER" OF THE BABYLOG 8000 IS AN INTEGRATED MICROPROCESSOR CONTROLLED DIGITAL VALVE ARRAY OF 10 VLVES FOR EACH AIR AND OXYGEN, WITH AN AUTOMATIC MICROPROCESSOR CONTROLLED SWITCHOVER, IN THE CASE OF INSUFFICIENT SUPPLY PRESSURE FOR EITHER AIR OR OXYGEN. THE VALVE ARRAY IS DIRECTLY CONTROLLED BY THE PNEUMATIC CONTROL BOARD AND PNEUMATIC ANALOG BOARD. ADDITIONALLY, THE BABYLOG 8000 HAS AN INTEGRATED, INDEPENDENT OXYGEN ANALYZER, WHICH WILL TRIGGER AN ALARM IN CASE OF A DEVIATION TO THE SET OXGYEN CONCENTRATION. THE DRAGER INC COMPLAINT FILE CONTAINS REPORTS ABOUT DEFECTIVE PNEUMATIC CONTROL BOARDS. IN THESE CASES, THE BABYLOG 8000 ALWAYS ALARMED VISUALLY AND AUDIBLE. THERE WHERE NO REPORTED INJURIES TO THE PT AS A RESULT OF THESE EVENTS.
HEAT AND MOISTURE EXCHANGER (HME) WAS IN USE WITH ANOTHER MFR'S BREATHING CIRCUIT AND METERED DOSE INHALER (MDI) ADAPTER. HME BECAME SEPARATED FROM MDI ADAPTER, RESULTING IN PT BRADYCARDIA AND ALARM CONDITION. PT WAS MANUALLY VENTILATED AND OXYGENATED WITH NO ADVERSE EFFECTS. USER HAS REPORTED THAT PERSONNEL HAVE BEEN INSTRUCTED TO ENSURE THAT ALL CONNECTIONS ARE SECURE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ON 2/22/96, AIDE USING A LIFT ATTEMPTING TO TRANSFER RESIDENT TO A WHEEL CHAIR. RESIDENT FELL OUT OF LIFT. RESIDENT HAD FRACTURE OF RIGHT FEMUR.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  .  SERVICE PROVIDED BY:  MANUFACTURER.  SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN, INCORRECT TECHNIQUE/PROCEDURE.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE BILATERAL BREAST IMPLANTS WITH MASTOPEXY AND CAPSULECTOMIES.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE BILATERAL BREAST IMPLANTS WITH CAPSULECTOMIES.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE OF BILATERAL BREAST IMPLANTSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
REMOVAL OF BILATERAL BREAST IMPLANTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE AND CAPSULECTOMIES.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE TISSUE EXPANDER FOR IMPLANT RIGHT BREAST.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS DESTROYED/DISPOSED OF.
EXCHANGE TISSUE EXPANDERS BILATERAL WITH IMPLANTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
RUPTURED BREAST IMPLANT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  OTHER.  CONCLUSION:  OTHER.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A FEEDING TUBE WAS PLACED AT THE USER FACILITY AND THE PT WAS SUBSEQUENTLY DISCHARGED TO A NURSING HOME. IT IS BELIEVED APPROX TWO WEEKS POST PLACEMENT THE INTERNAL BOLSTER MIGRATED THROUGH THE ABDOMINAL WALL. UNAWARE OF THIS MIGRATION FEEDING CONTINUED. THE PT DEVELOPED PERITONITIS AND SUBSEQUENTLY EXPIRED. NO FURTHER DETAILS WITH REGARDS TO THE CIRCUMSTANCES SURROUNDING THIS EVENT ARE AVAILABLE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  UNKNOWN.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR.  THE DEVICE WAS DESTROYED/DISPOSED OF.
A PT WITH THIS ICD SYSTEM RECEIVED INAPPROPRIATE SHOCKS. AN INVASIVE PROCEDURE WAS PERFORMED AND INSULATION ABRASIONS OF THE RATE SENSING LEADS WAS OBSERVED. A NEW RATE SENSING LEAD WAS IMPLANTED AND THE GENERATOR WAS ALSO ELECTIVELY REPLACED. IMPLANT DATE 9/14/92, EXPLANT DATE 2/19/96. TOTAL IMPLANT TIME 41 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
APPROX TWELVE PTS DEVELOPED ABRASIONS TO THE FRONT AND BACK OF LOWER HEELS WHICH REQUIRED DEBRIDEMENT PROCEDURE. THERE HAVE BEEN NO PREVIOUS INCIDENTS REPORTED AT ANY OTHER FACILITIES. THE MFR IS TRYING TO GET IN CONTACT WITH THE NURSE IN CHARGE TO DETERMINE SPECIFIC USAGE AND SIZING ISSUES. LABELING SPECIFIES APPROPRIATE MEASUREMENTS TO BE TAKEN TO ASSURE PROPER SIZE AND FIT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
FEMORAL HEAD REMOVED AND REPLACED WITH 26MM FEMORAL HEAD.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
POLY WEAR REPLACED WITH A 26MM ID ACETABULAR INSERT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
RESIDENT FOUND SITTING ON PEDALS OF WHEELCHAIR, TIPPED FORWARD WITH CRISS CROSS BELT RESTRICTION ABOUT HER NECK. ABSENCE OF VITAL SIGNS.
PT UNDERWENT CARDIAC CATH. ATTEMPTING ANGIO-PLASTY AT END OF PROCEDURE DEVELOPED HEART BLOCK AND A TEMPORARY PACER WAS INSERTED. SHORTLY THEREAFTER PT FOUND IN EMD. PT EXPIRED. CAUSE OF DEATH WAS HEMOPERICARDIUM CAUSED BY TEMPORARY TRANSVENOUS PACEMAKER WIRE PERFORATION. HEART MUSCLE VERY FRIABLE DUE TO DAMAGE FROM MI.
THE PT HAD AN ANGIOPLASTY 4/29/96. ON 4/30/96, THE BALLOON DEVELOPED A LEAK AND HAD TO BE REMOVED. THE PT EXPIRED A SHORT TIME LATER. MAY HAVE BEEN UNRELATED TO EVENT. PT WAS DNR AND HAD A LIVING WILL.
THE PT WAS ON A SPEAKING VALVE DURING THE DAY WITH A TWO LITER NASAL CANNULA DELIVERING OXYGEN. AT APPROX 2340 ON 4/26/96, THE THERAPIST ENTERED THE ROOM TO REMOVE THE NASAL CANNULA AND APPLY A 30% TRACHEOSTOMY MASK. IN ADDITION, THE SPEAKING VALVE WAS ORDERED TO BE REMOVED AT THIS TIME. THE THERAPIST DID NOT REMOVE THE VALVE BUT DID INFLATE THE CUFF ON THE TRACHEOSTOMY TUBE. APPROX ONE-HALF HR LATER, THE PT WAS FOUND UNRESPONSIVE AND A CART WAS CALLED. IT WAS DISCOVERED AT THIS TIME THAT THE VALVE WAS NOT REMOVED. THE PT WAS RESUSCITATED AND TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT WHERE HE SUBSEQUENTLY DIED.
DURING PERMANENT PACEMAKER IMPLANT PROCEDURE, PT'S BLOOD PRESSURE DECREASED AND CARDIAC ARREST ENSUED RAPIDLY. CPR WAS INITIATED AND APPROX 1 1/2 HRS INTO CPR A LARGE AIR EMBOLUS WAS DIAGNOSED BY PHYSICIAN UNDER FLUOROSCOPY. CPR ENDED APPROX 3 HRS LATER AND PT WAS PRONOUNCED DEAD APPROX 8 HRS AFTER END OF CPR CODE. IMMEDIATELY AFTER THE PROCEDURE, PHYSICIAN INSPECTED INTRODUCER SHEATH AND PACING LEAD AND STATED THE PACING LEAD TORE THE INTRODUCER SHEATH AND CREATED THE AIR EMBOLISM.
PT WITH ABDOMINAL PAIN, ADMITTED AND SURGERY PERFORMED. FIRST POSTOP DAY, ANTIEMBOLIC STOCKINGS REMOVED, PULSES PALPABLE; 2ND POSTOP DAY, STOCKINGS REMOVED - LEGS COLD, CYANOTIC, PULSELESS. NO EDEMA NOTED. ARTERIOGRAM: ATHEROSCLEROTIC PLAQUE WITH STENOSIS - RIGHT ILIAC ARTERY; OCCLUSION LEFT ILIAC ARTERY. CONCERN: LOW CARDIAC OUTPUT WITH RESULTANT DECREASED URINARY OUTPUT, HYPOXEMIA. ACUTE ARTERIAL OCCLUSION DUE TO LOW CARDIAC OUTPUT OR IMMOBILITY. ANTIEMBOLIC STOCKINGS REMOVED ONCE A DAY PER INSERT CONTENT IN PACKAGE. ANTIEMBOLIC STOCKINGS MAY HAVE CONTRIBUTED SECONDARILY TO DECREASED VASCULAR PERFUSION. UNKNOWN AFFECT OF STOCKINGS ON ARTERIAL SYSTEM.
PT DEVELOPED BACK PAIN THAT WENT INTO THE NECK, CHEST AND LEFT ARM, WHILE WALKING. ASSOCIATED WITH SOB, N & V AND DIARRHEA. ADMITTED VIA ER. HISTORY OF VALVE PLACEMENT 1993. CARDIAC CATHETERIZATION FOUND: SEVERE AORTIC INSUFFICIENCY WHICH APPEARED TO BE PARAVALVULAR IN ORIGIN. ON LIMITED FLUOROSCOPIC EXAM OF THE VALVE, INITIALLY IT WAS FELT TO FUNCTION NORMALLY. SOME VIEWS HOWEVER, SUGGEST THAT ONE OF THE LEAFLETS IN FACT MAY NOT BE OPENING AND CLOSING COMPLETELY. FURTHER STUDY SHOWED THAT ONE LEAFLET CLEARLY HAD RESTRICTED MOTION AND SOMEWHAT FIXED BETWEEN THE OPENING AND CLOSING POSITION. THE OTHER LEAFLET HAS SOME RESTRICTION IN FUNCTION, BUT IS NEARLY NORMAL. THIS STUDY CLEARLY SHOWS AORTIC VALVE PROSTHESIS DYSFUNCTION. TPA USED, PT DIED FROM CVA.
DURING A LAPAROSOCPY TUMOR REMOVAL PROCEDURE, PT'S BLOOD VESSEL WAS CUT. PROCEDURE WAS CONVERTED TO OPEN SURGERY AND PT WAS SAVED. PT IS CURRENTLY IN ICU.
PRE-OP DIAGNOSIS: RE-RUPTURE OF LEFT INTERNAL CAROTID POSTERIOR COMMUNICATING ARTERY ANEURYSM. SIGNS OF HEMORRHAGING. THEY BELIEVE CLIP MAY HAVE SLIPPED. ACTION TAKEN: LEFT CRANIOTOMY RE-APPLICATION OF CLIP. ADD'L EVALUATION OF LEFT TEMPORAL LOBE HEMATOMA, LEFT TEMPORAL LOBECTOMY.
POLY LINER SEPARATED FROM SHELL AFTER A FALL BY THE FEMALE PT. ALSO INCLUDED ARE 3 BONE SCREWS.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CO2 MONITOR KEPT RISING (PRESSURE WAS SET AT 15 MMHG). 1 CM HOLE WAS FOUND IN DIAPHRAGM AND PROCEDURE WAS CONVERTED TO OPEN SURGERY AND DIAPHRAGM WAS REPAIRED.
FACILITY REPORTED THAT 30 MINS INTO HEMODIALYSIS TREATMENT THERE WAS A BLOOD LEAK IN THE DIALYZER. EBL>100CC. THERE WAS NO PT INJURY AS REPORTED BY A HEALTHCARE PROFESSIONAL.
FACILITY REPORTED THAT A BLOOD LEAK OCCURRED 10 MIN INTO TREATMENT. EBL>100CC. DIALYZER WAS CHANGED AND TREATMENT RESUMED.
FACILITY REPORTED THAT 20 MINS INTO TREATMENT THERE WAS A BLOOD LEAK. EBL>100CC. THERE WAS NO PT INJURY AS REPORTED BY A HCP.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK IN THE DIALYZER. EBL>100CC. A NEW DIALYZER WAS USED AND TREATMENT RESUMED WITHOUT INCIDENT.
FACILITY REPORTED THAT A BLOOD LEAK OCCURRED AS SOON AS TREATMENT HAD STARTED. EBL 100CC. THERE WAS NO PT INJURY AS REPORTED BY A HCP.
FACILITY REPORTED THAT 2 MINS INTO TREATMENT THERE WAS A BLOOD LEAK. EBL>100CC. A NEW DIALYZER WAS USED AND TREATMENT RESUMED WITHOUT INCIDENT.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK 1 HR INTO TREATMENT. EBL>100CC. A NEW DIALYER WAS USED AND TREATMENT RESUMED.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK DURING TREATMENT. EBL>100CC. THERE WAS NO PT INJURY AS REPORTED BY A HCP.
BILATERAL SILICONE IMPLANT IN BOTH BUTTOCKS ON 10/26/95. SINCE THAT TIME THE SURGICAL WOUND HAS BECOME INFECTED. THERE IS DEHISCENCE OF THE WOUND, OBVIOUS INFLAMMATION, AND IMPLANTS ARE VISIBLE.
CABG/MV REPAIR 4/29/96 IABP INSERTED PERIOP. RETURN TO OR FOR INTRATHORACIC BLEEDING - SUBSEQUENTLY STABILIZED. RN CARING FOR PT ON POD#1 NOTED DECREASED AUGMENTATION AND BLOOD BACKING UP IN BALLOON LINE. BALLOON REMOVED. NOTED TO BE RUPTURED.
THIS 55-YR-OLD FEMALE HAD SILICONE GEL BREAST IMPLANTS FOR BILATERAL AUGMENTATION SEVERAL YEARS AGO. THIS REPORTING FACILITY HAS NO RECORD OF THE IMPLANTATION, THEREFORE, THE MFR IS UNKNOWN. THE PT PRESENTS WITH BREAST DEFORMITY AND CAPSULAR PAIN. GROSS EXAM: BOTH IMPLANTS HAVE SLIT-LIKE FENESTRATIONS WHICH EXUDE STICKY, STRINGY VISCOUS MATERIAL.
INTERFERENTIAL MUSCLE STIMULATOR DID NOT PERFORM TO THE MFR'S SPECS. AFTER MANY PHONE CALLS, MFR REPLACED IT UNDER WARRANTY. THE SECOND UNIT ALSO FAILED THE INITIAL INSPECTION. WITH THE SAME POOR CUSTOMER SVC AND UNAVAILABLE SVC DATA, THE UNIT WAS SENT BACK FOR A REFUND. DEVICE IS EXTERNALLY APPLIED. USED IN PHYSICAL THERAPY. PER CALL TO ORIGINAL RPTR.
WHILE PT WAS WALKING ON TREADMILL, THE BELT STOPPED SUDDENLY AND COMPLETELY. THERE WAS A NOTICEABLE BURNING ODOR, AND AN "OS" CODE WAS SHOWN IN THE SPEED DISPLAY. WHEN ATTEMPTING TO RESTART THE TREADMILL, WHEN THE START BUTTON WAS PUSHED, THE TREADMILL STARTED UP WITH THE BELT MOVING IMMEDIATELY AT TOP SPEED.
THE FIRST PT TO USE THE TREADMILL THAT DAY. AS PT WAS WALKING ON TREADMILL, THE BELT STOPPED SUDDENLY AND COMPLETELY. THERE WAS A NOTICEABLE BURNING ODOR, AND AN "OS" CODE WAS SHOWN IN THE SPEED DISPLAY. WHEN ATTEMPTING TO RESTART THE TREADMILL, WHEN START BUTTON WAS PUSHED, THE TREADMILL STARTED UP WITH THE BLET MOVING IMMEDIATELY AT TOP SPEED.
THIS 52-YR-OLD FEMALE HAD SILICONE BREAST IMPLANTS IMPLANTED AT ANOTHER FACILITY AND THE DATE OF IMPLANTATION WAS UNKNOWN TO THE PT. THE PT PRESENTS WITH COMPLAINTS OF DISCOMFORT AROUND THE LEFT BREAST MEDIALLY AND IN BOTH AXILLA. A RECENT MAMMOGRAM SHOWED EVIDENCE OF THE LEFT IMPLANT BEING RUPTURED. GROSS EXAM: THE RIGHT IMPLANT IS INTACT WITHOUT GROSS EVIDENCE OF LEAKAGE OF ITS CONTENTS. THE LEFT IMPLANT IS FOCALLY PERFORATED: A 0.1 CM DEFECT IS FOUND TO EXUDE A GELATINOUS AND TENACIOUS GEL-LIKE SUBSTANCE.
DURING A CARDIAC CATHERIZATION PROCEDURE A BURR WAS NOTED ON THE THIRD WIRE EXCHANGE. NO BURR WAS EVIDENT ON THE PREVIOUS TWO, OVER THE WIRE EXCHANGES.
IOL DISLOCATED AFTER SUTURING IN PLACE. HAPTIC FRACTURE AFTER SUTURING.
PT HAD REMOVAL OF SILICONE GEL BREAST IMPLANTS DUE TO CAPSULAR CONTRACTURES WITH HARDNESS AND PAIN ON RIGHT SIDE. PT HAD PREVIOUSLY UNDERGONE BILATERAL SUBCUTANEOUS MASTECTOMIES FOR SEVERE FIBROCYSTIC DISEASE WITH SILICONE GEL IMPLANT RECONSTRUCTION. THE RIGHT CAPSULE WAS NOTED TO CONTAIN A COPIOUS AMOUNT OF THICK BROWNISH FLUID AND A MARKED FIBRINOUS EXUDATE. THE RIGHT IMPLANT APPEARED TO BE INTACT. THE LEFT CAPSULE CONTAINED NO FLUID AND AN INTACT IMPLANT. RIGHT IMPLANT WEIGHED 215 GMS, LEFT IMPLANT 222 GMS. THE PATHOLOGY EVALUATION OF THE RIGHT CAPSULE REVEALED FIBROSIS WITH EVIDENCE OF EXTRAVASATION OF SILICONE AND HYALINIZED REACTIVE FIBROSIS, LEFT CAPSULE HYALINIZED FIBROSIS WITH EVIDENCE OF MINIMAL-SILICONE EXTRAVASATION. 350 CC SALINE IMPLANTS WERE USED FOR REPLACEMENTS.
SEVENTEEN-DAY-OLD PT WAS SEEN IN ER FOR FOREIGN BODY IN PARIETAL AREA OF SCALP. FOREIGN BODY WAS THE COILED WIRE OF A FETAL SCALP ELECTRODE (FSE) WHICH HAD BROKEN FREE OF ITS HUB UPON APPLICATION. TWO SCABS NOTED AROUND WIRE. NO EDEMA, ERYTHEMA, OR DAMAGE NOTED. FSE WAS APPLIED 8/8/95 AND ANOTHER FSE WAS USED TO MONITOR DUE TO THE WIRE SEPARATING. AT TIME OF DELIVERY, THE COILED WIRE COULD NOT BE FOUND ON NEWBORN.
LEFT HIP PROSTHESIS ORIGINALLY IMPLANTED 1/93. PT SOON BEGAN EXPERIENCING PAIN. X-RAYS REVEALED THAT THE POLYETHYLENE PORTION OF THE ACETABULAR COMPONENT WAS WORN AND THERE WAS ECCENTRIC LOCATION OF THE FEMORAL HEAD WITHIN THE ACETABULUM. SURGERY FOUND THE WEARING THROUGH OF THE POLYETHYLENE PORTION OF THE ACETABULAR COMPONENT WITH CONTACT OCCURRING BETWEEN THE FEMORAL HEAD AND ACETABULAR SHELL. OF NOTE, THE FEMORAL COMPONENT WAS LOCATED WITHIN THE ACETABULAR COMPONENT, HOWEVER, POLYETHYLENE LINER WITHIN THE ACETABULAR SHELL HAD WORN AND BECOME DISENGAGED.
THIS 45-YR-OLD FEMALE UNDERWENT BAM IN 1977. THIS REPORTING FACILITY HAS NO RECORD OF THE IMPLANTATION BEING PERFORMED HERE, THUS THE MFR IS UNKNOWN. THE PT WISHES EXPLANTATION DUE TO RECENT DEVELOPMENT OF LUMPS AND RHEUMATIC SYMPTOMS. GROSS EXAM: BOTH IMPLANTS ARE MASSIVELY DISRUPTED AND EXUDE GELATINOUS VISCOUS MATERIAL.
THIS 66-YR-OLD MALE HAD A SEMI-RIGID PENILE IMPLANT IMPLANTED 5 YEARS AGO AT ANOTHER FACILITY. THEREFORE, THIS REPORTING FACILITY DOES NOT HAVE ACCESS TO THE NAME OF THE MFR. THE PT DID WELL WITH THIS IMPLANT UNTIL ABOUT A WEEK PRIOR TO SURGERY WHEN HE STARTED DEVELOPING SOME SWELLING IN THE PENIS AS WELL AS PAIN AT THE GLANS AREA. SOME HEMATURIA WAS NOTED. AT THE TIME OF SURGERY, IT WAS NOTED THAT JUST LOOKING RIGHT INSIDE THE MEATUS, THE LEFT CORPORAL BODY PENILE PROSTHESIS HAD ERODED INTO THE URETHA.
A 30-YR-OLD MALE HAD A LEFT SUBCLAVIAN IMPLANTED PORT INSERTED 8/14/95. ON 1/22/96 THE CATHETER EITHER BROKE OR CAME APART AND MIGRATED DOWN AND LODGED IN THE PULMONARY ARTERY REQUIRING EXTRACTION AS AN OUTPATIENT. CATHETER WAS EXTRACTED WITHOUT COMPLICATION.
DISPENSING PIN LEAKS WHILE IN USE AROUND AIR INTAKE VENT.
PT IS A 12-YR-OLD FEMALE THAT PRESENTED ON 4/29/96 TO OUTPT GI LAB FOR REPLACEMENT OF G-BUTTON SECONDARY TO LEAKING OF CURRENT G-BUTTON. G-BUTTON REPLACED BY PEDIATRIC GASTROENTEROLOGIST WITHOUT DIFFICULTY. PT RE-PRESENTED BACK TO ER LATER THAT EVENING IN ACUTE DISTRESS. PT ARRESTED. RESUSCITATIVE EFFORTS NOT SUCCESSFUL AND PT EXPIRED. AUTOPSY RESULTS ON 5/31/96 REVEALED PERFORATION OF STOMACH.
PT PRESENTED FOR CARDIAC CATH ON AN EMERGENT BASIS. WHILE UNDERGOING THE PROCEDURE THE PT BEGAN TO EXPERIENCE CHEST PAIN. PROCEDURE CHANGED TO A PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY. ANOTHER CO'S STENT BECAME EXPLANTED DURING THE REMOVAL OF 3.5M BALLOON POST DILATION FOR STENT RESTENOSIS. PT BECAME BRADYCARDIC, REQUIRING A PACEMAKER, SEVERE HYPOTENSION, AS WELL AS EPISODES OF VENTRICULAR FIBRILLATION REQUIRING CPR AND INTUBATION. PT ALSO HAD AN INTRA-AORTIC BALLOON PUMP AND INTUBATION. INTRA-AORTIC BALLOON WAS REMOVED THE NEXT DAY. THE PT WAS ALSO EXTUBATED AND WAS DISCHARGED FROM THE HOSP ON 4/30.
PT WAS RECEIVING A NERVE BLOCK TO LEFT FEMORAL CUTANEOUS NERVE WITH NERVE STIMULATOR GUIDANCE. NERVE WAS LOCALIZED TO ELICIT PAIN AND ANESTHETIZED WITH MARCAINE USING A 25 GAUGE 2 INCH NEEDLE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE NEEDLE FROM PT, THE NEEDLE FROM HUB DRAIN REMAINED IN PT AND REQUIRED SURGICAL REMOVAL.
DURING AN OPERATIVE PROCEDURE, THE DEVICE WAS BEING USED TO STAPLE. HOWEVER, THE ENDS OF THE STAPLES CRISSCROSSED WHICH MADE THEM INEFFECTIVE. SEVERAL OF THESE STAPLES HAD TO BE REMOVED FROM THE PT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
THE CARDIAC MONITOR WAS ON AND ALARMS WERE SET. THE PT EXPERIENCED BRADYCARDIA THAT PROGRESSED TO ASYSTOLE. HOWEVER, THE BEDSIDE MONITOR AND THE CENTRAL NURSING STATION MONITOR DID NOT ALARM. IT IS UNCLEAR WHY THE ALARM DID NOT SOUND EVEN THOUGH IT WAS SET.
WHEN THE PRODUCT WAS USED FOR GAS STERILIZATION OF INSTRUMENTS WITH LENSES, IT AFFECTED THE INTEGRITY OF THE ADHESIVE AND CAUSED FOGGING AND COLOR CHANGES WITHIN THE INSTRUMENTS.
DURING AN ANGIOPLASTY, ONE BALLOON RUPTURED AND ONE FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED AFTER USING OTHER CATHETERS.
DURING AN ENT PROCEDURE IN THE ORAL CAVITY, THE SUTURE NEEDLE BROKE, AND THE NEEDLE COULD NOT BE RETRIEVED FROM THE OPERATIVE TISSUE SITE.
THE CO HAS TESTED THE ELECTRONICS UNIT OF THE INCUBATOR 8000 IC WITH INTENSITIES FROM 3 V/M UP TO 10 V/M (SEE TEST RESULTS). THE RESULT IS THAT THE INCUBATOR DOES NOT SHOW ANY PROBLEMS WITH FIELD UP TO 3 V/M, AS REQUIRED IN FDA PERFORMANCE SPECIFICATIONS. IN A SPECIFIC FREQUENCY BAND AND FIELD INTENSITY BETWEEN 5 AND 6 V/M, THE REACTION OF THE INCUBATOR RESULTED IN THE MDR REPORT THE EVENY OF JANUARY 10TH. EVEN THOUGH THE PRODUCT DOES FULLY COMPLY WITH THE IEC AND FDA ENVIRONMENTAL REQUIREMENTS, DRAGER INC. IS UPGRADING ALL CPU'S IN DRAGER INCUBATORS SOLD IN THE US AND CANADA DURING ROUTINE SVC INSPECTIONS. THIS WILL FURTHER ENHANCE THE RESISTANCE AGAINST ELECTRO MAGNETIC FIELDS BEYOND THE CURRENT INTL REQUIREMENTS.
ADD'L INFO RECEIVED 9/22/99: IT'S BEEN OVER 2 WEEKS SINCE RPTR AGREED TO TAKE $150,000.00 FROM TSRH MFR. ACCORDING TO RPTR DR ADMITS HE USED ACROMED SCREWS. HE WILL QUALIFY FOR 2 MILLION DOLLARS IN THE CLASS ACTION SUIT AND THIS WILL MAKE IT POSSIBLE TO GET THE TREATMENT HE DESERVES. RPTR STATES THAT DR PLACED 7.5 SCREWS WHICH ARE CM AND DANEK DOESN'T USE CM AND THIS IS THE ONLY PROCEDURE "I HAVE READ OUT OF 33 THAT DOESN'T GIVE PROPER BRAND OR SIZE. THERE IS NO WAY HE COULD HAVE PLACED 7.5 CM SCREWS IN L-4 AFTER FILLING IT WITH BONE WHICH FELL OUT. NOR COULD HE PLACE THEM IN S-1 WHICH HE HAD TO KEEP HELD IN WITH WIRE MESH BECAUSE HE RIPPED IT COMPLETELY FROM MY BODY. TOP SCREWS ARE IN L5, S1 HELD IN WITH WIRE MESH AND THE BONE USED TO CUT THE SACRUM INTO THE SHAPE OF S1 IS PLACED IN THE WIRE TO MAKE A FUSION WHICH FELL OUT AND ITS ONLY A MATTER OF TIME BEFORE IT FALLS OUT. HE PLACED THE SCEWS IN THE SACRUM." "I HAVE HIS ASSISTANT ON TAPE STATING THEY USED ACROMED AND THAT'S THEIR STANDARD PROCEDURE." ACCORDING TO RPTR THERE ARE 7 DIFFERENT MFRS AND DR WAS TAUGHT HOW TO INSTALL AND TAKE OUT ACROMED. HE DIDN'T GO TO THE OTHER 6 LEARNING EVERY SINGLE PROCEDURE." IN FACT HE DIDN'T EVEN READ THE PROCEDURE AS TO HOW THEY WERE INSTALLED OR HE WOULD HAVE LABELED THE NUTS HE SO CALLED REMOVED AS SELFLOCKING AND HE WOULD HAVE KNOWN THAT YOU CAN NOT TAKE A TORK WRENCH AND REMOVE 6 SCREWS WITH SELFLOCKING NUTS TORKED AT 150LBS. A HUGE AMOUNT OF PRESSURE AND YOU HAVE SEEN THE SCREWS BROKE IN TWO WITH THE NUTS STILL ON THE ENDS WHICH HE CLAIMED CAME LOSE AND THAT'S WHY THE ROD CAME OUT AND STABBED MY KIDNEY TO THE POINT I WAS URINATING BLOOD."
PT'S CONNECTOR ON END OF CENTRAL LINE WAS DEFECTIVE.
THE MAIN PROBLEM IS UNDERSTANDING WHAT THE SCALE IS READING WHEN IT IS IN USE IN THE INFANT MODE. THE SCALE HAD TWO MODES, ONE FOR INFANTS, AND THE OTHER ONE FOR ADULTS. IT ALSO GIVES YOU TWO CHOICES, POUNDS AND KILOGRAMS. WHEN IT IS USED IN POUNDS, THE DISPLAY READS 0.00 POUNDS. WHEN IT IS IN POUNDS/OUNCES, IF FOR EXAMPLE IT READS 10.13, IT DOES NOT MEAN 10 POUNDS AND .13 DECIMALS, IT MEANS 10 POUNDS, AND .13 OUNCES. "WE WERE CONFUSED AND DECIDE TO SEND THE SCALE WAS FINE."
DURING USE OF EQUIPMENT FOR ROUTINE CARDIOVERSION AND OTHER PROCEDURES, EXPERIENCED UNDULY LONG (BY REPORT OF STAFF) DELAY IN CHARGING, AND ARCING OF CURRENT. RESULTED IN NEED TO INTERVENE WITH OTHER EQUIPMENT IN ORDER TO AVOID DETRIMENTAL AND/OR TERMINAL EFFECT ON PT. BURNS TO PT OCCURRED (REDNESS). MULTIPLE OCCURRENCES (X2) PRIOR TO NOTIFICATION OF BIOMED OR RISK MGMT. INTERNAL TESTING OF EQUIPMENT WITH PADDLES: CHARGE TIME WAS AROUND 8 SECS TO MAX. R/O ARCING DID NOT HAVE ACTUAL PATCHES USED WITH PTS. NOT ABLE TO RECREATE PROBLEMS REPORTED BY STAFF.
LEG ON WALKER BROKE CAUSING INDIVIDUAL TO FALL, EXPERIENCING LACERATION TO BRIDGE OF NOSE AND "BUMP" TO FOREHEAD. PT HAS EARLY STAGES OF MULTIPLE SCLEROSIS, BUT AT THIS POINT USES WALKER FOR STABILITY AND NOT FOR WEIGHT BEARING.
WHEN ATTEMPTING TO ADJUST THE INFLATION/DEFLATION MARKERS ON THE BALLOON PUMP THE TIMING MARKERS MOVE COMPLETELY TO ONE END OF THE SCREEN, AS IF THE BUTTON IS STUCK. CONTACTED CO WITH PROBLEM. REP REPLACED THE PUMP HEAD AND THE UMBILICAL CABLE. SIMILAR PROBLEM OCCURRED ON ANOTHER PUMP ON 4/23/96 IN WHICH THE TIMING BAR MOVES TO ONE SIDE. REP REPLACED THE DISPLAY AND DISPLAY CABLE ON 4/24/96.
GRADIENT CABLES OF MRI SCANNER CAUGHT FIRE DURING SCAN. NO INJURY TO PT. LIGHT WENT OUT ON MONITOR WITH A FLASH IN THE BORE. PT EVACUATED WITHOUT INCIDENT. CABLES REPLACED.
EIGHTY-ONE-YEAR-OLD MALE ACCIDENTALLY PULLED OUT HIS OWN FOLEY CATHETER LEAVING A PORTION OF THE CATHETER IN HIS URETHRA. THIS WAS PUSHED BACK INTO THE BLADDER PRIOR TO REMOVAL OF THE RETAINED PIECE. ON 6/12/96 THE PORTION OF THE CATHETER WAS REMOVED DURING CYSTOSCOPY. A SMALL LACERATION WAS NOTED IN THE URETHRA. NO OTHER COMPLICATIONS OCCURRED.
AT APPROX 1:25 PM, AFTER A BOWEL MOVELMENT, PT DEVELOPED PULSELESS V TACH (UNRESPONSIVE TO IMMEDIATE PRECORDIAL THUMP), THEN V FIB. A "CODE BLUE" WAS CALLED. THE PT UNDERWENT THE USUAL ACLS PROTOCOL FOR V FIB. AFTER THE THIRD SHOCK, THE PT HAD A BRIEF RUN OF SINUS RHYTHM WITHOUT A PALPABLE PULSE THAT QUICKLY DEGENERATED INTO V TACH THEN V FIB. AT SOME POINT (LESS THAN ONE MIN) AFTER THE THIRD SHOCK, THE SCREEN ON THE DEFIBRILLATOR WENT "BLANK" AND DID NOT SHOW ANY IMAGE. TURNING THE "ON/OFF/ENERGY SELECT" DIAL DID NOT "TURN ON" THE MACHINE. THE UNIT WAS THEN PLUGGED INTO THE ELECTRICAL OUTLET IN THE ROOM, BUT NO EKG SIGNAL, NO LIGHTS OR ANY EVIDENCE THAT THE UNIT WAS ELECTRICALLY FUNCTIONAL WAS EVIDENT. THE UNIT WAS REMOVED, AND THE PT WAS ATTACHED TO SECOND CO DEFIBRILLATOR AND UNDERWENT THE REMAINING PORTION OF ACLS PROTOCOL, INCLUDING 7 ADD'L SUCCESSFULLY DELIVERED DEFIBRILLATIONS. THE PT NEVER REGAINED A PULSE OR BLOOD PRESSURE AND THE "CODE BLUE" WAS TERMINATED AT 1:49 PM. TIME BETWEEN THIRD DEFIBRILLATION AND FOURTH DEFIBRILLATION WITH SECOND MACHINE WAS 5 MINS. IT IS IMPOSSIBLE TO ASSESS EFFECT OF FAILURE OF DEFIBRILLATOR TO DELIVER A FOURTH DEFIBRILLATION ON FINAL PT OUTCOME. TIME BETWEEN RECOGNITION OF A POTENTIAL PROBLEM WITH FIRST DEFIBRILLATOR AND DELIVERY OF A SUBSEQUENT SHOCK BY SECOND DEFIBRILLATOR WAS SHORT, AT 5 MINS. ALSO, FAILURE TO RESPOND TO THE ACLS PROTOCOL WAS NOT UNEXPECTED GIVEN PT'S AGE AND WELL DOCUMENTED END-STAGE DILATED CARDIOMYOPATHY. OF NOTE, PER ICU POLICY, BATTERY CHARGES ON DEFIBRILLATORS ARE CHECKED TWICE PER DAY. DEFIBRILLATOR IN QUESTION WAS CHECKED THAT MORNING AND FOUND TO BE FUNCTINAL. IN 1/96, THE UNIT PASSED ALL INSPECTION REQUIREMENTS, INCLUDING BATTERY. ON 5/24/96 BIOMEDICAL ENGINEER TECHNICIANS WERE NOTIFIED AND ARRIVED APPROX 0.5-2 HRS AFTER THE CODE CEASED. TECHS CONDUCTED A PHYSICAL INSPECTION OF UNIT WITH NO DISCREPANCIES NOTED. UNIT WAS SHIPPED TO MFR ON 6/6/96 FOR FURTHER EVALUATION AND TESTING.
DURING THE COURSE OF A CEREBRAL ANGIOGRAM AND BALLOON OCCLUSION OF THE BASILAR ARTERY, THE PT'S ANEURYSM RUPTURED AND THE PT UNDERWENT A RESPIRATORY ARREST.
AT APROX 4:21 AM ON 3/20/96, THE PT WAS FOUND IN HER HOSP ROOM WITH HER UPPER TORSO LEANING ON THE BED AND HER LEGS TOUCHING THE FLOOR. HER HEAD WAS WEDGED BETWEEN THE AIRBED MATTRESS AND THE BEDRAIL. A CODE BLUE WAS ALARMED AND CARDIOPULMONARY RESUSCITATION WAS INSTITUTED AND WAS UNSUCCESSFUL. THE PT WAS PRONOUNCED DEAD AT 4:30 AM ON 3/20/96. AFTER THE INCIDENT, THE AIRBED WAS INSPECTED BY CO AND FOUND TO BE IN SOUND CONDITION. AN AUTOPSY WAS PERFORMED AND THE CORONER FOUND THAT A CONTRIBUTING FACTOR WAS TRAUMATIC ASPHYXIA AND CHRONIC OBSTRUCTIVE PULMONARY EMPHYSEMA.
ON 4/22/96 AT 3:30 PM RESIDENT WAS FOUND ON FLOOR AFTER APPARENTLY TRYING TO GET OUT OF BED. SIDE RAIL WAS IN DOWN POSITION. RESIDENT SUFFERED FRACTURED LEFT HIP. THERE WERE NO WITNESSES TO EVENT. ASSISTANT DIR OF MAINTENANCE AND WRITER RE-ATTACHED SIDE RAIL TO BED ON 5/2/96. HOSP IS UNABLE TO MAKE SIDE RAIL FAIL. HOSP BELIEVES THAT NURSING ASSISTANT DID NOT LOCK SIDE RAIL IN UP POSITION AND THEREFORE, WAS POSSIBLY HUMAN ERROR. ON 5/8/96 RESIDENT EXPIRED FROM CONGESTIVE HEART FAILURE.
PT DIAGNOSED WITH CVA ON 4/27/96. NASOGASTRIC TUBE FEEDINGS BEGAN ON 4/29/96, PT NOT TOLERATING-REGURGITATING. PEG TUBE PLACED ON 5/1/96, FEEDINGS VIA PEG TUBE STARTED ON 5/2/96 AT 0600. FEEDINGS RAN APPROX 2 HRS AND FEEDING STOPPED BECAUSE PT BEGAN COMPLAINING OF ABDOMINAL PAIN. QUESTIONED REACTIVE ILEUS SECONDARY TO PEG PLACEMENT. FEEDINGS PUT ON HOLD THE MORNING OF 5/2/96 AND LATER RESUMED THAT DAY AT APPROX 1800. PT CONTINUED TO COMPLAIN OF ABDOMINAL PAIN ON MORNING OF 5/3/96. ATTENDING PHYSICIAN ORDERED SURGICAL CONSULT. UPON EXAMINATION BY SURGEON, PEG TUBE DISLODGED WITH BALLOON DEFLATED. ATTEMPT MADE TO INJECT AIR INTO BALLOON TO RE-INFLATE, LEAK NOTED AND BALLOON WOULD NOT RE-INFLATE. PEG TUBE NOT REINSERTED. PT STARTED ON ANTIBIOTICS. PT'S TEMP ELEVATING ON 5/3/96 TO 101.4F. IN AFTERNOON OF 5/3/96, YELLOW DRAINAGE NOTED FROM PEG TUBE SITE. PT'S URINARY OUTPUT DECREASING, BLOOD PRESSURE DROPPING, RESPIRATIONS LABORED AND PT UNRESPONSIVE. PT EXPIRED.
PT RECEIVING IV CLAFORAN 1GM IN 250 ML/NS VIA PUMP. PT CALLED AGENCY TO NOTIFY THEM THAT TUBING HAD DISCONNECTED FROM BAG AND WAS LEAKING EVERYWHERE. NURSE INVESTIGATED AND FOUND THAT TUBING WAS DEFECTIVE AND DISLODGED FROM BAG SPIKE THEREBY SOUNDING OFF PUMP ALARM. PT MISSED DOSE OF ANTIBIOTIC BUT SUFFERED NO ADVERSE EFFECTS/REACTIONS.
AS THE NURSE REMOVED THE INFUSION FROM THE NURSING UNIT REFRIGERATOR, THE TOP SEAM OF THE IV BAG RIPPED. SHE DENIES AGGRESSIVELY HANDLING THE BAG. THE INFUSION HAD TO BE DISCARDED (PARENTERAL NUTRITION SOLUTION - COMPOUNDED ONCE DAILY) AND AN INFERIOR REPLACEMENT COMPOUNDED FOR THE PT.
CHILD, 11 YEARS OLD, WAS HAVING HER TEMPERATURE TAKEN. FOR NO APPARENT REASON, THERMOMETER BROKE OFF IN HER MOUTH. FORTUNATELY CHILD SPIT OUT THE GLASS AND THE MERCURY. CHILD DID NOT BITE THE THERMOMETER.
3ML SYRINGES HAVE A CHRONIC PROBLEM WITH DEFORMED PLUNGER TIPS. THE CURVATURE IN THE TIP MAKES ACCURATE MEASUREMENTS IMPOSSIBLE AS THE READING WILL BE AS MUCH AS 1/10 CC DIFFERENT DEPENDING ON HOW ONE TURNS THE PLUNGER.
TECH INSERTED 22G NEEDLE INTO PT'S ARM. THE TECH APPLIED TUBE AND ATTEMPTED TO REPOSITION TUBE BY PULLING BACK WHEN BLUNTING APPARATUS DISENGAGED FROM INSIDE OF NEEDLE AND CAME OUT OF PT'S ARM. THE NEEDLE REMAINED IN THE PT'S ARM AND WAS STILL AFFIXED TO PLASTIC HOLDER. BLOOD COULD HAVE EASILY SQUIRTED OUT OF NEEDLE HUB.
WHILE PT WAS IN THE BED, THE CAPACITOR TO THE MOTOR THAT CONTROLS THE HEAD OF THE BED CAUGHT FIRE. FIRE WAS PUT OUT BY SECURITY STAFF. THE FIRE DEPT WAS CALLED BUT FIRE WAS OUT WHEN THEY ARRIVED. NO INJURIES OCCURRED.
ACE DOES NOT CURRENTLY UTILIZE SERIAL OR MODEL NUMBERS. THE PART NUMBER IS THE SAME AS THE CATALOG NUMBER.
PACEMAKER FAST IN VVI MODE. MAGNET RATE ABOUT 80. SX: FULLNESS IN THE NECK AND SYNCOPE. ORIGINALLY INSERTED 6 YEARS AGO.
PERIPHERAL ACCESS DEVICE PLACED BY INTERVENTIONAL RADIOLOGY. THIS DEVICE WAS A SAMPLE PROVIDED BY THE MFR. IT WAS NOT ASSEMBLED CORRECTLY BY PHYSICIAN (SEAL NOT TIGHT). CHEMOTHERAPEUTIC DRUG EXTRAVASATES AROUND CATHETER. MILD INJURY NOT REQUIRING TREATMENT.
TWO ATTEMPTS WITH A 26G. ON ALL ATTEMPTS RPTR GOT A GOOD BLOOD RETURN, BUT WAS UNABLE TO THREAD CATH. AFTER THE 3RD ATTEMPT, PT SAID HE WAS HAVING A "HOT FLASH" AND FELT NAUSEATED. HE PUT HIS HEAD DOWN ON THE DESK. LESS THAN A MIN LATER HE SLUMPED OVER AND APPEARED NOT TO BE BREATHING. RPTR CALLED FOR HELP - WHILE ANOTHER WOMAN THERE (PT'S CO-WORKER) AND RPTR GOT PT TO FLOOR TO OPEN HIS AIRWAY, THE MGR CALLED 911. AS RPTR WAS MOVING HIM TO THE FLOOR PT HAD A SEIZURE AND THEN AS THEY POSITIONED HIS HEAD TO OPEN HIS AIRWAY HE CAME TO AND BROKE OUT INTO A COLD SWEAT. HE WAS ALERT AND ORIENTED WITHIN A MATTER OF MINS. HE WANTED TO SIT UP. HE WAS VERY PALE AND C/O HANDS FEELING NUMB. PARAMEDICS ARRIVED, ASSESSED PT, INSERTED DIFFERENT CATH IN HIS LEFT HAND ON 2ND ATTEMPT AND PREPARED TO TRANSPORT PT TO HOSP ER. BEFORE THEY LEFT - AT 3:45 PM RPTR SPOKE TO DR WHO SAID PT DID NEED TO RECEIVE DOSE OF ROCEPHIN. PT CONSENTED AND RPTR ADMINISTERED 2GM IVP OVER 5 MIN, TOLERATED WELL. PT THEN TAKEN TO ER BY PARAMEDICS. AT 6:00 PM RPTR CALLED HOSP ER AND WAS INFORMED THAT PT WAS SEEN IN ER AND SENT HOME.
TESTED EQUIPMENT PRIOR TO USE WITH NO PROBLEMS. HAS NOT BEEN USED, NEW AS OF LAST WEEK. WAS BROKEN WHEN AGAIN TESTED. NOT USED WITH COLONOSCOPE OR ON A PT - UNIT CLEAN.
PT UNDERWENT SURGERY FOR A TORN ACL OF THE LEFT KNEE WITH TORN MEDIAL MENISCUS ON 5/23. DURING PROCEDURE, WHILE USING THE RING CURRETTE FROM THE ARTHROSCOPY, THE TIP OF THE RING PORTION OF THE INSTRUMENT BROKE OFF IN THE PT'S LEFT KNEE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE TIP VIA ARTHROSCOPY BUT WAS UNSUCCESSFUL. THERE WAS NO ATTEMPT MADE TO PERFORM OPEN SURGERY TO THE KNEE.
WHILE MOVING THE CEILING MOUNTED LEAD SHIELD AWAY FROM THE PT, THE ARM BALL JOINT SHEARED IN TWO, HITTING THE EMPLOYEE IN THE LEFT ARM AND ELBOW. NO FRACTURES PRESENT, EMPLOYEE EXPERIENCING SEVERE TENDONITIS/SORENESS. CO SERVICED EQUIPMENT ONE WEEK PRIOR TO INCIDENT, BECAUSE IT HAD BECOME DIFFICULT TO MOVE. CO HAD LUBRICATED THIS JOINT, BUT RPTR WONDERS IF IT WAS METAL FATIGUE.
LEFT SILICONE BREAST IMPLANT FOUND TO BE RUPTURED UPON EXPLANTATION. REPLACED WITH SALINE BREAST IMPLANT.
UPON EXPLANTATION, BILATERAL SILICONE BREAST IMPLANTS WERE FOUND TO BE RUPTURED. THEY WERE SURGICALLY REMOVED.
CT SCAN ON FRIDAY SHOWED BULGING AT BOTH L4-5 AND L5-S1. DISCOGRAM AT BOTH L4-5 AND L5-S1 SHOWS A HERNIATED DISC AT BOTH LEVELS. DR INJECTED 1CC OF DEPO-MEDROL IN EACH SIDE TO SEE IF THAT WOULD ELIMINATE SOME OF THE PAIN. BILATERAL LATERAL FUSION AND BILATERAL POSTERIOR FUSION, L4 TO THE SACRUM. BILATERAL BONE STIMULATOR INSERTION. BILATERAL PEDICULAR FIXATION WITH THE EQUIPMENT. ON 8/15/89 THE PT WAS ADMITTED TO THE HOSP WITH RIGHT UPPER QUADRANT PAIN FOR 36 HRS DURATION WITH A STEADY ACHING PAIN, NAUSEA, ANOREXIA, AND REPEATED EMESIS. SHE DENIED CHILLS BUT PRESENTED WITH A FEVER OF 101 DEGREES WITH MILD TENDERNESS IN THE RIGHT UPPER QUADRANT, NO REBOUND, AND NO MASSES. WORKUP INCLUDED ABDOMINAL FILMS WHICH WERE NONSPECIFIC, ULTRASOUND OF THE LIVER AND BILE DUCTS WHICH WAS NORMAL. SHE ALSO HAD A VENTILATION PERFUSION SCAN WHICH DEMONSTRATED A LOW PROBABILITY FOR PULMONARY EMBOLISM. LAB WORKUP INITIALLY DEMONSTRATED A LEUKOCYTOSIS OF 16.4 WHICH RETURNED TO NORMAL AT 9,000. THE SED RATE WAS ELEVATED AT 90 MM/HR. THE SMA-20 WAS NORMAL EXCEPT FOR A GLUCOSE OF 198 WITH IV'S RUNNING. THE ALKALINE PHOSPHATASE WAS 280; GAMMA-GT 323; SGOT 42; SGPT 89. PROTHROMBIN TIME WAS NORMAL. THE PT RAN A FEBRILE COURSE FOR MOST OF HER HOSPITALIZATION. BY HER FOURTH DAY OF HOSPITALIZATION, SHE WAS AFEBRILE WITHOUT ABDOMINAL PAIN, TOLERATING A REGULAR DIET, AND WAS READY FOR DISCHARGE WITHOUT RPTR EVER HAVING CLEARLY DETERMINED A DIAGNOSIS. ORTHOPEDIST AND PMD BOTH SAW THIS PT. THEIR FEELING WAS THAT THE PT'S FEVER WAS IN ALL LIKELIHOOD NOT SECONDARY TO A SURGICAL INFECTION IN HER BACK. 2/6/90 PT WAS WORRIED ABOUT A BUMP IN HER BACK; IT SEEMS TO BE THE STIMULATOR. DR HAD X-RAYS MADE; THE FUSION IS HEALING WELL, SO REMOVAL OF THE STIMULATOR HAS BEEN SCHEDULED.
DR HAS NOT BEEN FRANK AND TRUTHFUL TO RPTR AND OTHER DIALYSIS PTS ABOUT REUSE DIALYZERS. RPTR WAS UNDERGOING DIALYSIS TREATMENT BY REUSE DIALYZERS 55 TIMES AS WELL AS OTHER DIALYSIS PTS AT THIS DIALYSIS CTR. THE DIALYSIS STAFF THERE WILL NOT REVEAL WHAT TYPE OF DISINFECTANT THEY USE FOR REUSE DIALYZERS OR EXPLAIN ANY RISKS TO DIALYSIS PTS. DIALYSIS PTS ARE PRESSURED INTO ACCEPTING REUSE DIALYZERS BY HEAD NURSE AND KIDNEY DR. DR COERCES DIALYSIS PTS INTO DIALYSIS TREATMENTS ON SPECIFIC TYPE DIALYSIS MACHINES - NONCOMPUTERIZED WHICH CAUSES INTENSE SUFFERING AND PROBLEMS FOR DIALYSIS PTS (OF WHICH THE DIALYSIS STAFF THERE KNOWS WELL) IF DIALYSIS PTS REFUSE REUSE DIALYZERS.
LPN WHILE MAKING ROUNDS FOUND RESIDENT SUSPENDED FROM RIGHT SIDE OF BED WITH RESTRAINT AROUND HER BREAST PLATE. RESIDENT HAD NO PULSE OR RESPIRATION.
CONFUSED, RESTRAINED, PT PULLED OUT CATHETER. INTRODUCER VALVE PULLED APART AND AIR INTRODUCED INTO HEART AFTER VALVE PULLED OUT. PT ARRESTED, WITNESSED BY PRIMARY SURGEON AND NURSES. RESUSCITATIVE EFFORTS BEGUN IMMEDIATELY. PT EXPIRED DESPITE APPROPRIATE MEASURES.
PT ADMITTED TO TELEMETRY UNIT. FOUND UNRESPONSIVE, ASYSTOLE. RESCUSITATIVE EFFORTS UNSUCCESSFUL. UPON INITIAL INVESTIGATION TELEMETRY UNIT FAILED TO TRIGGER ALARM IN RESPONSE TO RHYTHM CHANGE.
IABP ALARMING SLOW GAS LEAK. PUMP PLACED ON OVERIDE CONTROL FOR APPROX 15 MIN. ALARMED AGAIN, UNABLE TO REFILL. PT IN ASYSTOLE, EXPIRED.
CONNECTION BETWEEN SHEATH AND CATHETER BECAME DISCONNECTED CAUSING LINE TO LEAK. CARE PROVIDER REMOVED LINE WITHOUT REMOVING SHEATH AND APPLYING PRESSURE, POSSIBLY CAUSING AN AIR EMBOLISM.
WHEN NURSE OPENED PACKAGE SHE NOTICED A HUMAN HAIR IN STERILE PACKAGE. HAIR ACTUALLY ENTRAPPED IN PRODUCT WHERE TWO PARTS WERE GLUED TOGETHER. WAS NOT USED ON PT.
PT CALLED ON 6/19 TO INFORM DR'S STAFF OF HER ALLERGY TO LATEX. STAFF DIDN'T LEAVE ANY EXAMINATION ROOM FREE OF LATEX. WHEN PT ARRIVED, STAFF EXPERIENCED MILD TO MODERATE ITCHING. PT MEDICATED HERSELF WITH 10 MG OF PREDNISONE. DR AND STAFF DON'T IDENTIFY OPEN GLOVE BOXES AS A PROBLEM. FACILITY HAS NO LATEX PROTOCOL OR OFFERS IN-SVC FOR LATEX EXPOSURE. ER IS NOT PREPARED TO DEAL WITH A SERIOUS REACTION (SHOCK). TO RESCHEDULE AN APPOINTMENT WITH DR A 6 MONTH WAIT WOULD OCCUR.
PT CALLED FACILITY'S RISK MGMT AND OUTPATIENT SVS TO INFORM THEM OF HER ALLERGY TO LATEX. SHE ASKED TO BE THE FIRST PT IN OFFICE. A LATEX TOURNIQUET WAS IN ROOM. NURSE HANDLED TWO MORE TOURNIQUETS IN THE ROOM. PT ASKED NURSE TO WASH HANDS AND REMOVE THE TOURNIQUETS FROM THE ROOM. NURSE DREW THE BLOOD. WITHIN 15 MINS OF LEAVING THE FACILITY, PT EXPERIENCED SEVERE ITCHING. PT TOOK 20 MG OF PREDNISONE. PT TOOK 50 MG BENADRYL AND 10 MG "ZYSTEC" BEFORE GOING TO THE FACILITY. PT NOTIFIED RISK MGR OF THE REACTION. PT FEELS STAFF WAS NOT TRAINED PROPERLY.
OUT OF BOX FAILURE OF OXYGEN YOKE ASSEMBLY ON NEONATAL INTENSIVE CARE CTR. AFTER PUTTING UNIT INTO LABOR AND DELIVERY OR AND ATTACHING O2 SUCTION HOSES, RPTR DISCOVERED THERE WAS NO OUTPUT FOR THE O2. REMOVED UNIT TO SHOP AND HAD SVC REP INSPECT AND REPAIR UNIT. RPTR DISCOVERED THAT THE BALL BEARING STUCK DUE TO TOO MUCH LUBRICANT. REP PUT NEW ASSEMBLY IN AND IT FAILED. CO INSTALLED A SECOND ASSEMBLY BEFORE UNIT WORKED. ON 6/12/96 ATTACHED WALL OXYGEN TO YOKE ASSEMBLY ON INFANT WARMER. NO OUTPUT OFF THE YOKE ASSEMBLY VERIFIES AS OUTPUT FROM WELL. CALLED IN SVC REP.
PER HEALTHCARE PROFESSIONAL, URINE BAGS ARE NOT DRAINING. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT.
PER HEALTHCARE PROFESSIONAL, URINE BAGS ARE NOT DRAINING AND URINE IS BACKING UP INTO THE PT'S BLADDER. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT.
PT COMPLAINS OF DIFFICULTY DUE TO POOR RIGIDITY OF MALLEABLE PROSTHESIS. REMOVAL OF PENILE PROSTHESIS WITH PLACEMENT INFLATABLE PROSTHESIS.
MONITOR POPPED AND SCREEN WENT BLANK. SAW FIRE AND STARTED TO SMOKE. PT MOVED TO ICU. MONITOR IN ICU IS UNPLUGGED.
DURING A LAP CHOLECYSTECTOMY, VENTILATING PRESSURES RAPIDLY INCREASED TO 60-70 WHEN SMOKE EVACUATOR WAS TURNED ON. ABDOMINAL PRESSURE WENT INTO 20'S. WHEN EVACUATOR TURNED OFF, PRESSURES RETURNED TO NORMAL. EVACUATOR TURNED ON X2, WITH SAME RESULTS. EVACUATOR NOT USED FOR REMAINDER OF CASE. "TANDEM" CAP ON SMOKE EVACUATOR FOUND UNCAPPED AT THE END OF THE CASE. NO ALARM ON MEDICAL DEVICE. PNEUMOTHORAX WAS IDENTIFIED ON CHEST X-RAY, 14G CATH PLACED TO ASPIRATE PNEUMOTHORAX.
PERITONEAL PT NOTED AIR IN OUTFLOW LINE OF "ULTRA-BAG" DURING DRAIN PROCEDURE. PT IGNORED AIR AND PROCEEDED WITH THE "FILL" PROCEDURE. THE AIR RESULTED FROM A LEAK IN THE TUBING AT THE "Y" JUNCTION OF THE DRAIN AND FILL LINES. THERE MAY HAVE BEEN POOR BONDING OF THE TUBING AND THE "Y" JUNCTION, HOWEVER, RPTR IS UNABLE TO CONFIRM THIS. THE POOR BOND MAY HAVE RPOVIDED A PORT OF ENTRY FOR BACTERIAL CONTAMINANTS. THE PT EXPERIENCED PERITONITIS.
STATUS POST AUGMENTATION WITH SPONTANEOUS DEFLATION OF LEFT BREAST IMPLANT INITIALLY IMPLANTED IN 8/86. REVISION OF LEFT BREAST WITH OPEN CAPSULOTOMY AND REPLACEMENT OF DEFLATED IMPLANT.
WHILE USING WALKER, LEFT SIDE OF WALKER COLLAPSED CAUSING PT TO FALL. PT WENT TO HER REGULARLY SCHEDULED DR'S VISIT. UNKNOWN IF MEDICAL TREATMENT WAS REQUIRED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
HOT COMPRESSES WERE BEING USED ON CHILD'S LEFT ANTICUBITAL FOSSA AND RIGHT OUTER LEG IN PREPARATION FOR INTRAVENOUS LINE INSERTION. WHEN REMOVED, BLISTERING OF THE CHILD'S SKIN WAS NOTED IN BOTH LEFT ANTICUBITAL FOSSA AND RIGHT LOWER OUTER LEG. AREAS WERE TREATED WITH SILVADENE TWICE DAILY FOLLOWED BY STERILE DRESSINGS. LABELING FOR THIS PRODUCT CLEARLY STATES "DO NOT APPLY DIRECTLY TO SKIN."INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A STUDENT WAS BREAKING OUT FROM USING LATEX EXAM GLOVES. STUDENT ALSO HAS A PRACTICE WHERE HE USES OTHER GLOVES NOT DISTRIBUTED BY CO. UNABLE TO DETERMINE IF REACTION WAS FROM CO GLOVES.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PULSE GENERATOR (IPG) WAS EXPLANTED DUE TO EROSION OF THE POCKET. IMPLANT DATE IS 10/13/94. EXPLANT DATE IS 2/13/96. IMPLANT TIME IS 16 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH AN IMPLANTABLE PULSE GENERATOR (IPG) AND BIPOLAR LEAD EXHIBITED AN INCREASE IN PACING THESHOLDS AND NON-CAPTURE OF ARRHYTHMIA. AN INVASIVE PROCEDURE WAS PERFORMED TO EXPLANT THE SYSTEM. IMPLANT DATE IS 1/11/95. EXPLANT DATE IS 4/12/96. TOTAL IMPLANT TIME IS 15 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEADS WERE REMOVED FROM SVC FOR INSULATION FAILURE. IMPLANT DATE IS 10/12/92. EXPLANT DATE IS 4/8/96. TOTAL IMPLANT TIME IS 42 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PULSE GENERATOR (IPG) WAS EXPLANTED FOR "SENSING DIFFICULTY." IMPLANTED ON 6/20/94. EXPLANTED ON 3/14/96. IMPLANTED FOR 20.8 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING THE BATTERY REPLACEMENT OF THIS PT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THESE SUTURELESS MYOCARDIAL LEADS WERE REMOVED FROM SVC FOR INSULATION FAILURE. IMPLANT DATE IS 12/30/91. EXPLANT DATE IS 4/23/96. TOTAL IMPLANT TIME IS 51 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING THE REPLACEMENT OF A DEFIBRILLATOR (ICD) FOR NORMAL BATTERY DEPLETION, ALL FOUR CHRONIC EPICARDIAL LEADS WERE CAPPED AND REPLACED BECAUSE THE PT HAD RECEIVED INAPPROPRIATE SHOCKS. IMPLANT DATE IS 2/7/92. OUT-OF-SVC DATE IS 2/9/96. IMPLANT TIME WAS 48 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PULSE GENERATOR (IPG), WHICH IS DISTRIBUTED THROUGH ANOTHER PACEMAKER CO, WAS EXHIBITING LOSS OF CAPTURE SHORTLY AFTER IMPLANT. IMPLANT DATE IS 3/20/96.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEADS WERE REMOVED FROM SVC BECAUSE OF A LEAD FRACTURE. IMPLANT DATE IS 2/11/92. OUT OF SVC DATE IS 3/26/96. TOTAL IMPLANT TIME WAS 49.5 MO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT HAD ALMOST COMPLETE INCONTINENCY OF THE MEDIAL COLLATERAL LIGAMENT AT FIRST SURGERY. THE KNEE HAD LOOSENED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PCA PUMP DELIVERED 220 MG MEPERIDINE IN 2 HOURS. IT SHOULD HAVE DELIVERED 120 MG IN 2 HOURS. THE MACHINES SETTINGS WERE DOUBLE CHECKED BY ANOTHER RN, THEY WERE THE CORRECT SETTINGS TO DELIVER 120 MG IN 2 HOURS.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-AUG-95.  SERVICE PROVIDED BY:  INVALID DATA.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CATH PLACED ON 2/15/96. HEAD NURSE NOTIFIED AT 0700 HUB BROKEN OFF FROM THE CATHETER. HUB FOUND IN PT'S BED. PICC LINE REMOVED FROM PT.
STATUS POST AUGMENTATION MAMMOPLASTY WITH SPONTANEOUS DEFLATION OF THE LEFT BREAST IMPLANT. REVISION OF LEFT BREAST WITH REPLACEMENT OF BREAST IMPLANT.
INSERTING CATHETER DILATORS INCLUDED IN KIT WERE BENDING, GUIDE WIRES ALSO BENDING. 2 KITS OPENED AND USED, AND FINALLY A TRIPLE LUMEN CATHETER USED FOR STRONGER DILATOR. AFTER CATHETER FINALLY PLACED AND DR TUNNELLED THE DISTAL END OF THE CATHETER 6-8 INCHES OF THE CATHETER BROKE OFF. THIS REQUIRED HIM TO SHORTEN THE TUNNEL AND LEAVE A PIGTAIL OF HALF THE NORMAL LENGTH OF 3 INCHES.
REMOVAL OF RIGHT BREAST IMPLANT FOR DISCOMFORT COMPLAINTS. IMPLANT FOUND INTACT; DID HAVE FIXATION PATCHES WHICH STUCK AND ADHERED TO SURROUNDING CAPSULE AT IMPLANT REMOVAL. TOTAL CAPSULECTOMY DONE. ELECTIVE REMOVAL.
SEROMA AS ONE WEEK AFTER DRAIN REMOVED; EVACUATED. PT DESIRES REMOVAL IMPLANT DUE TO FEAR OF DELAYING CHEMO AND DELAYED HEALING. 50CC SEROUS IN IMPLANT CAVITY; IMPLANT NOTED AS INTACT BY MD.
2ND STAGE RECONSTRUCTION. OPEN CAPSULOTOMY AND IMPLANT EXCHANGE, LEFT ALSO NIPPLE AREOLAR RECONSTRUCTION. LARGER IMPLANT FOR BETTER SYMMETRY.
2ND STAGE REMOVAL EXPANDER CAPSULOTOMY TO REPOSITION PACKET AND INSERTION RECONSTRUCTION IMPLANT. (LEFT SALINE).
RIGHT CAPSULECTOMY AND IMPLANT EXCHANGE WITH SALINE. IMPLANT WAS SILICONE. ADD'L SURGERY OF RHYTIDECTOMY, QUADRILATERAL BLEPHAROPLASTY.
LEFT CAPSULECTOMY AND SILICONE IMPLANT EXCHANGE WITH SALINE. ADD'L SURGERY UNRELATED OF RHYTIDECTOMY, QUADRALATERAL, BLEPHAROPLASTY. FOUND LEFT HAD SURROUNDING SCAR CAPSULE CAUSING OBLONG LOOK.
C/O CHRONIC FATIUGE, RECEIVING SKIN AND EYE INFECTIONS. CURRENTLY LIVING IN SAUDI ARABIA. BILATERAL CAPSULAR CONTRACTURES. RT IMPLANT RUPTURED POSTERIORLY. LEFT IMPLANT RUPTURED POSTERIORLY. IMPLANTED 18 YEARS AGO.
PT DESIRES SUB-PECTORIAL CONVERSION FOR SAGGING BREASTS.
RIGHT BREAST DISCOMFORT; MAMMOGRAM REVEALED RUPTURED IMPLANT. LEFT IMPLANT WAS ALSO FOUND TO BE RUPTURED.
WITHIN THE FIRST 90 DAYS OF OPERATION 102 OF 320 PUMPS (32%) FAILED DUE TO PROBLEMS WITH THE PRESSURE SENSOR. THIS REQUIRED REMOVING THE PUMP FROM THE PT. IT HAS BEEN A SIGNIFICANT PROBLEM FOR PTS ON SHORT LIFE, VASOACTIVE DRUGS. ALL PUMPS HAVE NOW BEEN REMOVED FROM SVC BY THE USER AS THEY AWAIT CORRECTIVE ACTION FROM THE MFR.
0.22U FILTER LEAKED AT JUNCTURE BETWEEN LUER LOCK ATTACHMENT TO IV TUBING WITH NO APPARENT REASON. THE CONNECTION WAS TIGHT WITH NO APPARENT CRACKS OR ABNORMALITIES. THIS OCCURRENCE CREATED AN "OPEN SYSTEM" DURING THE IV INFUSION PUTTING THE PT AT RISK FOR INFECTION, AND ADDITIONALLY MED WAS A CYTOTOXIC AGENT.
TODAY IN DR'S OFFICE DR WAS CHANGING A TRACHEOSTOMY ON A PT WHO IS A QUADRAPLEGIC AND VENTILATOR DEPENDENT. PT USES #8 CUFFLESS TRACHS. PT BROUGHT ONE HERE. IT DID NOT APPEAR THAT THERE HAD BEEN ANY TAMPERING OR ANYTHING WRONG WITH THE TRACH SET, BUT UPON OPENING THE PLASTIC BAG, DR DISCOVERED THAT THE INNER CANNULA WAS MISSING. OBVIOUSLY, THIS COULD HAVE SERIOUS IMPLICATIONS FOR A VENTILATOR DEPENDENT PT. FORTUNATELY, OFFICE HAD A STERILIZED INNER CANNULA FROM A PREVIOUS TRACH SET, AND USED THAT ONE.
BILATERAL BREAST AUGMENTATION 3/18/96 PARTIAL DEFLATION OF LEFT IMPLANT. IMPLANT CHANGED 6/10/96, IMPLANT INTACT AT TIME OF REMOVAL. NO APPARENT HOLES, POSSIBLE VALVE LEAK.
TPN PUMP ALARMED. PT FOUND THAT FILTER CLOGGED WHILE INFUSING 100CC TRIPLE MIX TPN. PT STATES TPN INFUSED WITHOUT DIFFICULTY ONCE FILTER REMOVED. NO PT INJURY SUSTAINED BUT DOSE TPN INFUSION MISSED DUE TO PROBLEM WITH ALL FILTERS PT HAD FROM SPECIFIC LOT #.
PT BECAME TANGLED IN PACEMAKER EXTENSION CORD AND (+) PRONG BROKE OFF. HEART RATE DROPPED AND EXTENSION CORD WAS DISCONNECTED AND REPLACED. BP STABLE, ASYMPTOMATIC.
PT C/O PAIN AND SORENESS AT IV SITE AND LEFT UPPER ARM. IV LINE FLUSHES SLUGGISHLY, IV DISCONTINUED. PICC WAS 20G 3FR 15 3/4" LONG WITH BEVELED END. MOL REPLACED WITH CEPHALIC BY RN. GOOD BLOOD RETURN NOTED BUT PT TENSED ARM AND C/O HURTING AT INSERTION SITE SO MOL REMOVED. MOL THEN PLACED RIGHT ARM/22G. CATHETER ADVANCED 5"5 WITHOUT DIFFICULTY. PT THEN BECAME FLUSHED, BEGAN CRYING "I CAN'T BREATHE," MOL IMMEDIATELY REMOVED, BP 160/90, 842 EPIPENL : 1000, 3MG GIVEN IM LT LEG. PT CONTINUES TO CRY AND C/O INABILITY TO BREATHE. 22G CATH PLACED LT HAND AND NS STARTED. KVO EYELIDS SWOLLEN AND PT STATES "MY THROAT IS SWELLING SHUT". BILATERAL BREATH SOUNDS, CLEAN AND GOOD AIR MOVEMENT. C/O SEVERE ABDOMINAL CRAMPING "FEELS LIKE LABOR PAINS". ENT CLINIC CALLED DR, NOTIFIED OF PT STATUS. PT C/O "ITCHING ALL OVER". 50MC DPH GIVEN IVP. DECADRON 10MG GIVEN, IVP PER MD ORDERED AND EPIPEN REPEATED D/T CONTINUED EDEMA EYELIDS AND CONTINUED COMPLAINT BY PT OF DIFFICULTY BREATHING. ORDERS RECEIVED TO HAVE PT TRANSPORTED TO LOCAL ED, FOR EVALUATION. 911 NOTIFIED AT 113 PM AND REPORT CALLED TO RN. EMS ARRIVED AT 125 P. PT TRANSPORTED TO HOSP. VS AS FOLLOWS: 12:25 130/80-80, 12:30 BP/100-80, 12:45 160/110-80, 1P 130/100-80, 1:25P 112/88-84. PT REMAINED AWAKE, ALERT AND RESPONSIVE THROUGHOUT ENTIRE EVENT.
PROSTHESIS LOST FLUID AND BECAME FLAT. DEVICE REMOVED AND REPLACED WITH NEW MAMMARY PROSTHESIS 6/7/96.
DURING VENTRICULOSCOPY SURGEON NOTICED SEVERAL SMALL PARTICLES IN PT'S VENTRICLE WHICH APPEARED TO HAVE BROKEN OFF FROM THE SCOPE. ALL PARTICLES WERE REMOVED AND PROCEDURE WAS COMPLETED.
ON TWO SEPARATE OCCASIONS INVOLVING TWO DIFFERENT PTS, THE DEVICE TERMINATED TREATMENT PRIOR TO DELIVERING ANY RADIATION. IN BOTH CASES, A "FINISH BEAM" FILE WAS CREATED IN WHICH A NUMBER OF BEAM PARAMETERS (IE FIELD SIZE, GANTRY ANGLE, ETC) WERE ALTERED FROM THOSE ORIGINALLY PRESCRIBED. THE SYSTEM THEN PROMPTED THE OPERATOR TO "FINISH BEAM?". IF THE OPERATOR HAD ANSWERED "YES" THE SYSTEM WOULD HAVE PERMITTED TREATMENT WITH THE WRONG BEAM VALUES. IN THE TWO CASES CITED, THE ANOMALIES WERE IDENTIFIED AND THE OPERATOR WAS INSTRUCTED TO DELETE THE CORRUPTED "FINISH BEAM" PRESCRIPTION AND RESET THE SYSTEM. BOTH PTS WERE THEN CORRECTLY TREATED WITHOUT INCIDENT. IT SHOULD BE NOTED THAT UNTIL THE "FINISH BEAM" FILE IS DELETED, THE SYSTEM WILL PROMPT THE OPERATOR TO TREAT THE PT ON SUBSEQUENT DAYS WITH THE ALTERED BEAM DATA. THE INCIDENTS WERE REPORTED TO THE MFR IN ENGLAND WHO COULD NOT EXPLAIN THE REASON FOR THE PREMATURE TERMINATION OF THE BEAM. THEY DID STATE THAT THIS WAS "A KNOWN SOFTWARE PROBLEM THAT WILL BE FIXED IN A FUTURE SOFTWARE RELEASE SOMETIME IN 1997." OPERATORS WERE CAUTIONED ABOUT THE ABOVE CONDITION AND THE NECESSITY OF CONSTANT VIGILANCE DURING TREATMENT DELIVERY. THEY WERE ALSO INSTRUCTED ABOUT THE IMPORTANCE OF IMMEDIATELY DELETING THE CORRUPT "FINISH BEAM" FILES. MFR HAS REQUESTED THAT A BACKUP TAPE BE SENT TO ENGLAND IN THE EVENT THAT THE PROBLEM SHOULD OCCUR AGAIN. THE MFR, HOWEVER, HAS YET TO ISSUE A WARNING NOTICE TO THE END USERS REGARDING THIS SITUATION, DESPITE THE FACT THAT THIS IS A RECOGNIZED DEFICIENCY FOR WHICH NO SOLUTION IS IMMEDIATELY FORTHCOMING.
THREE-WHEELED SCOOTER TOOK OFF ON ITS OWN. COULD ONLY BE STOPPED BY REMOVING KEY. AFTER INSERTING KEY, SCOOTER ACTION WAS ERRATIC. SOMETIMES FORWARD, REVERSE, OR NOT AT ALL. SOMETIMES WHEN ACTIVATED, OTHER TIMES WITHOUT BEING ACTIVATED. FINALLY RETURNED TO DEALER AND RETURNED TO FACTORY. A BAD SITUATION FOR A HANDICAPPED PERSON.
FLOATER" IN TPN BAG UNLIKELY TO BE CORE MATERIAL FROM ADDITIVE VIALS DUE TO COLOR AS WELL AS LARGE SIZE. "FLOATER" DISCOVERED PRIOR TO ADMINISTRATION TO PT.
THE 20CC LUER LOCK SYRINGE IS RESISTANT TO INFUSION BY ANOTHER MFR'S PUMP WHEN GREATER THAN 10CC IS USED IN SYRINGE. PLUNGER IS STICKING AND MUST BE MANUALLY INFUSED.
DEFIB-PADS CONTAIN ONLY DATE OF MFR, NOT EXP DATE. PRODUCT IN RPTR'S ASU-MFR 1/85 QUESTION ABOUT SHELF-LIFE. PROTOCOL IS 3 YRS - WHY IS THIS NOT INDICATED ON PACKAGING? PADS LOSE CONDUCTIVE CAPABILITIES. THE NEW PROD CONTAINS A 3 YR EXP DATE, BUT HOW WOULD PEOPLE KNOW TO DISCARD THE PREVIOUS PRODUCT? PERHAPS A RECALL - TO LET OTHERS KNOW PRODUCT # 2346 IS OBSOLETE SINCE 9/95 - AND REPLACE WITH #2346N?
IT WAS NOTICED MIDWAY THROUGH THE PT'S 1ST NIGHT THAT THE FOLEY CATHETER HAD BEEN PULLED OUT BY THE PT, HOWEVER, THE END OF THE CATHETER HAD BROKEN OFF. VIA CYTOSCOPY THE BROKEN END OF THE CATHETER WAS FOUND MID URETHRA AND REMOVED W/GRASPING FORCEPS. ANOTHER FOLEY CATHETER WAS INSERTED AND RECOMMENDED TO STAY IN PLACE FOR ONE WEEK, PER UROLOGY. THE ORIGINAL FOLEY PLACED WAS A PEDIATRIC FOLEY.
RPTR HAD A 500CC EXPANDER IN HER BODY FROM 11/93 - 6/94 DUE TO A SUB-MASTECTOMY. RPTR DOES NOT BELIEVE EXPANDER CAUSED HER BONE PROBLEMS NOR DOES SHE BELIEVE 18 RADIATION TREATMENTS CAUSED THIS PROBLEM. NOW LIMITED AND DISABLED TO CERTAIN THINGS IN HER JOB. RPTR BONES BECOME PAINFUL. RPTR CAN STILL FUNCTION, AND IS CURRENTLY HOLDING DOWN A FULL TIME JOB. SHE DOES NOT KNOW IF SHE HAS NERVE PROBLEMS. SHE HAS NOT GONE TO A NEUROLOGIST. SHE DOESN'T KNOW HOW MUCH SALINE WAS ACTUALLY PUT IN EXANDER. DR DOCUMENTED 540CC. SHE COMPLAINED A LOT ABOUT THIS BUT SURGEON TOLD HER IT WOULD MESS UP ELASTICITY AND HER BREAST WOULDN'T BE RIGHT IF HE TOOK IT OUT. HE HELD UP A COPY OF A BROCHURE OF A TEARDROP AND TOLD HER IT SHOULD LOOK LIKE THAT PICTURE IF SHE LEFT IT IN. DR TOLD RPTR AT ANOTHER TIME THAT HER IMPLANT WAS BACKORDERED. SURGEON KNEW SHE WAS HURTING WITH PRESSURE. RPTR CALLED DR'S OFFICE AND HIS NURSE GOT ON PHONE AND RPTR TOLD HER SHE WAS SUFFERING AND FELT LIKE SHE WAS GOING TO DIE WITH THAT EXPANDER IN AND NURSE TOLD RPTR IT WAS EITHER WAIT FOR THE BACK-ORDER, OR PUT SILICONE GEL IN. HE PUMPED SALINE IN IN HIS OFFICE AND RPTR REMEMBERS WHEN HE PUMPED IT IN HE LET SOME OF IT OVERFLOW AND GO INTO HER BODY AND SHE FELT "SICK ON MY STOMACH" FOR A FEW DAYS. THESE BONE INJURIES ARE NOT CO'S FAULT. THERE IS A SCAR TISSUE CAPSULE IN PATHOLOGY LAB. EXPANDER CAME OUT IN 6/94 AND AT THAT TIME AN IMPLANT WAS PLACED AND RPTR WAS TOLD EXPANDER WAS BROKEN IN HER BODY. EXPANDER WAS NOT SENT TO PATHOLOGY. IMPLANT WAS PLACED IN A SIX AND A HALF MONTH OLD SCAR TISSUE CAPSULE. DR JUST STUCK IT IN THERE, HE DID NOT SCORE OR DO ANYTHING TO IT. IN 7/94 DR INFORMED RPTR SHE MIGHT NEED AN OPEN CAPSULOTOMY AND TOLD HER THERE WAS 120CC IN HER IMPLANT. SHE COMPLAINED TO HIM OF HER RIBS HURTING AND HOW SORE IT WAS UNDER LEFT TOP RIGHT OF IMPLANT.(*)
PT REPORTED THIS TUBING SET TO BE DEFECTIVE. IV SOLUTION WAS LEAKING OUT FROM THE JUNCTION BETWEEN THE PLASTIC SPIKE AND TUBING.
WHEN THE TRANSFER SET TUBING IS REMOVED AFTER FILLING THE BAG, THE REMAINING END THAT IS SUPPOSED TO BE CAPPED IS A MALE END. BUT THE CAPS PROVIDED ARE ALSO MALE. THIS HAS OCCURRED ON AT LEAST 3 OCCASIONS.
DEFLATED LEFT BREAST IMPLANT EXCHANGE FOR SALINE. CAPSULOTOMY - TWO PIN HOLES DETECTED WITH SALINE INJECTED AFTER DEFLATION OF REMOVED IMPLANT.
TIP OF 2MM RING CURET USED AT DEPTH OF 10MM DISATTACHED DURING USE IN BONE. FOUND TO NOT BE FREE BUT EMBEDDED IN BONE. EVENT OCCURRED DURING DRILLING OF SUBCHONDRAL BONE OF LEFT KNEE ARTHROSCOPY. METAL FATIGUE PER MD.
PENILE PROSTHESIS ERODED INTO PERIRENAL AREA. PT ALSO HAS A SACRAL DECUBITUS ULCER. ADMITTED WITH UROSEPSIS PERIRECTAL ABCESS AND NECROTIZING FASCIATUS. SURGERY THE LEFT CYLINDER OF PROSTHESIS WAS VISIBLE. THE RIGHT CYLINDER HAD THE REAR TIP EXTENDERS OUT.
AMBU BAG DOES NOT REFILL/REINFLATE ON ITS OWN. SQUEEZE PORTION OF BAG IS DIMPLED AND DOES NOT RETURN TO FULL FILLED POSITION.
ON ARRIVAL OF PT TO THE POST ANESTHESIA CARE UNIT, THE PT REQUIRED SUCTIONING OF EXCESSIVE SALIVA. THE SUCTION CATHETER WAS USED AND THE TIP CAME OFF WHILE SUCTIONING. THE TIP WAS QUICKLY REMOVED FROM THE MOUTH USING A FINGER SWEEP. NO RESPIRATORY PROBLEMS WERE NOTED. MFR WILL PICK UP AND GIVE COMPLETE CREDIT.
POST-OPERATIVE PT ON CARDIO-THORACIC SURGICAL INTENSIVE CARE UNIT COMPLAINED OF URETHRAL PAIN UPON REMOVAL OF CATHETER. CATHETER WAS IN PT FOR LESS THAN 24 HRS. PHYSICIAN REPORTED THE INABILITY TO COMPLETELY DEFLATE BALLOON. THIS MADE FOR A WASHBOARD EFFECT OR DEFECT WHICH WAS EXTREMELY PAINFUL FOR THE PT WHEN THE CATHETER IS WITHDRAWN ACROSS THE TENDER URETHRAL LINING UPON REMOVAL. THE SAME SITUATION WITH THE CATHETER CAN BE REPRODUCED BY INSERTING 5CC OF WATER INTO THE BALLOON AND THEN REMOVING.
THE BALLOON OF THE BLUNT TIP TROCAR RUPTURED AND WAS DISCOVERED AFTER IT WAS INSERTED INTO PT'S ABDOMEN. THE TROCAR WAS REMOVED AND REPLACED. IT WAS EXAMINED FOR POSSIBLE CAUSES AS WELL AS POTENTIAL MISSING FRAGMENTS, WHICH WAS NOT ABLE TO BE DETERMINED. THE SURGEONS LOOKED AROUND THE ABDOMINAL CAVITY, CONNECTED NEW TROCAR TO SEARCH FOR POSSIBLE FRAGMENTS, AND NONE WERE FOUND.
THREE PROBLEMS ENCOUNTERED. THE TWO LUER-LOCK PORTS CAUSE DIFFICULTY WHEN TRYING TO MAINTAIN A CONNECTION WITH IV TUBING. ON THREE SEPARATE OCCASIONS THE STOPCOCK, WHILE IN THE ALL OFF POSITION, FAILED TO PREVENT THE FLUID FROM ESCAPING THRU THE PORTS. THIS FAILURE LEAD TO THE NURSE BEING EXPOSED TO A LARGE AMOUNT OF THE PT'S BLOOD. THE 33 INCH EXTENSION TUBING IS TOO LONG FOR USE WITH LABOR AND DELIVERY PTS. DURING A PERIOD OF FETAL DISTRESS A PT COULD INADVERTENTLY RECEIVE A BOLUS OF PITOCIN WHICH MAY CAUSE INJURY TO THE INFANT.
THIS FACILITY HAS RECEIVED SEVERAL COMPLAINTS ABOUT THE QUALITY OF CONDOMS. PUBLIC HEALTH ER HAVE RECEIVED ABOUT 45 COMPLAINTS COLLECTIVELY. THE CONDOMS BREAK EASILY DURING USE AND THEY ARE NOT FITTING PROPERLY (TOO SMALL). PUBLIC HEALTH STATED THAT THESE CONDOMS ARE UNFIT FOR INTENDED USE.
FILTER SET WAS LEAKING FROM CYLINDER (FILTER) PORT WHEN INFUSING FLUIDS TO THE PT. OCCURRED TWICE IN A ROW.
THE INTERIOR AND EXTERIOR OF THE GLOVES APPEAR AS IF IT HAS BEEN MELTED BY THE SUN. THE FINGERS AND INTERIOR OF THE GLOVES ARE FOUND STUCK TOGETHER, AND WHEN ONE INSERTS HAND, IT IMMEDIATELY TEARS.
INSERTION TUBE FLAKING AND PEELING. UNABLE TO USE ON PT PROCEDURES - SENT TO CO FOR REPAIR. CO STATES "CHEMICAL REACTION FROM USE OF STERILANT." CONTACTED STERILANT MFR WITH THIS CHARGE AND THEY INFORMED RPTR OF SIMILAR OCCURRENCES WITH THE SAME MODEL SCOPE - INDICATIVE OF A MFG DEFECT. RPTR HAS DIFFERENT MODEL CO'S SCOPES, ALL WHICH ARE PROCESSED IN THE SAME MANOR. THIS SITUATION HAS NOT OCCURRED WITH ANY OTHER MODEL OR MFR SCOPE. THIS ALSO SUGGESTS A MFG DEFECT. THIS IS THE 2ND OCCURRENCE WITHIN A 10 MONTH PERIOD. INVOICE FOR REPAIR 5600.00.
THERE ARE SEVERAL PROBLEMS WITH THIS PARTICULAR PRODUCT. A STRAND OF HAIR WAS FOUND IN ONE CONTAINER AND ANOTHER WAS FOUND TO HAVE A CRACK IN THE PLASTIC WHICH LEAVES DOUBT TO THE STERILITY OF THE SPONGES. ALSO, SEVERAL CONTAINERS THAT WERE OPENED HAD MORE THAN TEN SPONGES. IN AN EMERGENCY WHEN THE QUANTITY OF SPONGES CAN'T BE VERIFIED THEN THE CHANCES OF LEAVING A SPONGE IN THE PT IS GREAT RESULTING IN HAVING TO OPEN THE PT UP AGAIN TO TAKE THE SPONGE OUT. THE PROBLEM HAS BEEN FOUND MAINLY IN ONE LOT BUT ALL LOTS HAVE BEEN SUSPENDED DUE TO THE NATURE OF THE PROBLEM.
MFG DEFECT IN PLASTIC RETAINER OR ALUMINUM GROOVE THAT HOLDS THE ACRYLIC SHIELD INTO THE SUNTANNING BED, IN THAT SHIELD FALLS OUT FROM ABOVE CUSTOMER. SHIELD IS SHARP AND HEAVY, PLASTIC RETAINER IS TOO WEAK. COMPLAINANT STATES THAT MANY OTHER OWNERS OF TANNING BEDS HAVE THIS PROBLEM; NO INJURIES YET BUT PROBABLE FROM CONTINUED USE. COMPLAINANT HAS REPORTED THIS TO CO AND SAYS FIRM TOLD HIM TO REPLACE VINYL RETAINING STRIP. COMPLAINANT SAYS THIS IS IMPRACTICAL AS STRIP WOULD HAVE TO BE  REPLACED.
THIS COMPLAINANT IS AN EXPERIENCED NURSE THAT ROUTINELY SETS UP PTS (HOME USE SETTING) WITH IV SETS, AND VARIOUS PUMPS INCLUDING INSULIN PUMPS LIKE THIS DEVICE. IN ADDITION SHE HAS BEEN USING VARIOUS INSULIN PUMPS FROM SAME CO OVER THE LAST TWO YEARS. ON 4/20/96 SHE HAD HER PUMP STOP INFUSING WITH NO ALARM AND SHE EXPERIENCED A SIGNIFICANT SUGAR LEVEL RISE. AFTER CALLING THE MFR AND FILING A COMPLAINT, IT STARTED WORKING AGAIN BUT ON MONDAY 4/22/96 IT HAPPENED AGAIN. SHE THEN WENT TO HER BACKUP AND THAT DIDN'T WORK EITHER. HER BACKUP IS ALSO THE SAME MODEL PUMP. THEREFORE THERE WERE THREE SIMILAR FAILURES IN 48 HRS ON TWO DIFFERENT MODELS. SHE REPORTED THEM TO CO. SHE NOW WILL NOT USE AN INSULIN PUMP BECAUSE SHE DOES NOT TRUST THEM. SHE ALSO FILED 4 MORE COMPLAINTS FOR VARIOUS FAILURES PREVIOUSLY, SUCH AS A04 OCCLUSION ALARM. THE PUMP GOES INTO 04 DURING PRIME, THIS HAPPENED ON 4 OCCASIONS. A02 LOW MOTOR BATTERY. THERE WAS A CRACK BY THE O2 BATTERY COMPARTMENT. THIS HAPPENED TWICE. A07 ELECTRONICS ALARM. FAILED TECH CHECK, THE PUMP WENT INTO AN 07 ALARM IN LESS THAN AN HR. THE MOTOR WAS DEFECTIVE. THE PUMP WAS NOT RETURNED FROM REPAIR. HAPPENED TWICE.
IN 1/86 RPTR HAD A REPEAT CESAREAN SECTION DONE, AND HAD MONOFILAMENT SUTURES (WIRE SUTURES 2.0) USED TO CLOSE HER INCISION AND HOLD A NETTING FOR HERNIA IN PLACE. IN 5/95 SHE BEGAN TO HAVE SEVERE ABDOMINAL PAINS. SHE WENT TO HER GYN DR WHO DID SEVERAL TESTS BUT COULD NOT FIND THE CAUSE, SO SHE SENT HER TO A SURGEON. HE DID FURTHER TESTS AND DISCOVERED THAT THE STITCHES HAD BROKEN INSIDE OF HER ABDOMEN AND WRAPPED AROUND THE WIRE MESH AND CAUSED ALL OF THE PROBLEMS. HE DID AN OPERATION AND REMOVED THE WIRE MESH AND SUTURES. 6 WEEKS LATER SHE BEGAN TO HAVE MORE PAINS, AND WENT BACK TO DR. HE HAD MORE TESTS DONE AND DID AN EXPLORATORY SURGERY, FOUND "LARGE SERMONE CAVITY" IN HER ABDOMEN WHICH TO THIS DAY DOES NOT HEAL. SHE HAD OTHER OPERATIONS AFTER THIS LAST ONE AND NOW SHE IS SCHEDULED TO SEE A PLASTIC SURGEON TO TRY AND SEE IF THEY CAN GET THE OPEN WOUND TO HEAL.
COMPLAINANT STATES THAT ON 1/10/94, HIS SPOUSE RECEIVED A HIP REPLACEMENT. ACCORDING TO THE COMPLAINANT, THE REPLACEMENT HIP "CAME OUT OF THE SOCKET TWICE" AND IN 5/95, A 2ND REPLACEMENT WAS DONE. HE STATED THAT ON REMOVAL OF THE 2ND PROSTHESIS, IT WAS NOTED THAT THE OUTER SHELL OF THE PROSTHESIS EXHIBITED SLIGHT DEFORMITY OF THE OUTER SPOKES AND THE METAL MARGINS OF THE BALL APPEARED SLIGHTLY ERODED WITH LIGHT BROWN DISCOLORATION OVER AN AREA MEASURING 6MM IN LENGTH, ALONG WITH A METAL EROSION AREA OF 1MM AT THE BASE OF THE BALL.
SUSPECTED DEFECT OF NEEDLE. WHILE INJECTING 30 GAUGE NEEDLE TO TREAT PT FOR PAIN MANAGEMENT NEEDLE BROKE OFF AT HUB.
RN PLACED THE CATHETER DURING THE PROCEDURE, THE PT BLED AS EXPECTED BUT THE DRAPE DID NOT SOAK UP THE BLOOD AT ALL. IT BUBBLED THEN RAN ONTO THE FLOOR. THEN ONTO THE RN'S SHOES & SOAKED THROUGH HER NYLONS. THE DRAPES NEED TO SOAK UP THE BLOOD TO AVOID HEALTH RISKS SUCH AS THIS. EXPIRATION DATE 11/98.
ONE WAY VALVE WAS BACKWARDS. ALLOWED FOR BACKWASH AND CONTAMINATION.
INFUSION DEVICE RAN APPROPRIATELY FOR 2 DAYS AND THEN STOPPED.
VENTILATOR SUPPORTING PT'S RESPITATORY NEEDS BECAME DISCONNECTED (LOOSENED, BUT NOT COMPLETELY UNPLUGGED) FROM POWER SOURCE. INTERNAL VENTILATOR FAILURE AUDIBLE/VISUAL ALARMS NEVER ACTIVATED. CAREGIVER (RESPIRATORY THERAPIST) RECOGNIZED SITUATION IMMEDIATELY UPON VISUAL ASSESSMENT AND RECONNECTED VENTILATOR TO POWER AND SUPPORTED THE PT, FOLLOWED BY REMOVING THIS VENTILATOR FROM SERVICE. EQUIPMENT WAS RETURNED FROM MFR ON 5/21/96 WITH REPORT OF 'NO PROBLEMS' FOUND.
ON 5/13/96 ENGINEER LEARNED FROM THE HOSP THAT THE INFUSION PUMP ALLOWED FREE FLOW OF MEDICATION INTO A PT ON 4/30/96. THE HOSP DECIDED TO CALL IN A CONSULTING CO TO TEST THE UNIT ON 5/9/96. ENGINEER WAS NOT PROVIDED DETAILS ON THE PT CONDITION AFTER THE INCIDENT AND WHETHER SERIOUS INJURY HAD OCCURRED. THE UNIT WAS RETURNED ON 5/22/96 AND INSPECTED ON 5/28/96. THE UNIT WAS FOUND TO OPERATE WITHIN SPECIFICATIONS WHEN THE PUMPING MECHANISM WAS CLOSED BY PUSHING THE ORANGE LATCH, AS INSTRUCTED IN THE OPERATING INSTRUCTIONS PROVIDED. A TRIANGULAR-SHAPED TAB INSIDE THE DOOR THAT PRESSES AGAINST THE ORANGE LATCH WHEN THE DOOR IS CLOSED WAS FOUND TO BE BROKEN AND MISSING.
WANTED LARGER SIZE. 300CC SIZE REMOVED AND 375CC SIZE IMPLANTED. IMPLANTED 2/11/93, EXPLANTED 6/7/96.
PT UNDERWENT AN ERCP WITH STENT PLACEMENT. WHEN TRYING TO PLACE THE STENT THRU THE SCOPE, IT FAILED TO DISPLAY X2. PT HAD TO HAVE PROCEDURE REPEATED 2 DAYS LATER. IMPLANTED 5/28/96, EXPLANTED 5/30/96.
PUMP MALFUNCTIONED AND WHEN INFUSION SHOULD BE COMPLETED, THERE WERE APPROX 200ML LEFT. EXPIRATION DATE 11/96.
PCA AMBULATORY INFUSION PUMP WHILE IN SERVICE REGISTERED ERROR. EXPIRATION DATE 10/96.
WHILE TRANSFERRING RESIDENT FROM HER BED TO HER WHEELCHAIR BY LIFTER WITH THE ASSISTANCE OF TWO (2) CO-WORKERS LIFTER GAVE WAY AND RESIDENT FELL TO FLOOR ON HER LEFT SIDE. NO TEST REQUIRED. RESIDENT EVALUATED AT EMERGENCY ROOM.
IV FLUID DOESN'T GO THROUGH THE DRIP CHAMBER.
THE VENTILATOR SHUTOFF AND THE LIGHTS WENT OUT DURING CLOSED SUCTIONING. THE VENTILATOR BEGAN TO CYCLE AGAIN AFTER 3 TO 4 SECONDS.
DURING SURGERY THE CIRCULATING NURSE WAS ASKED TO GIVE TOBRADEX ON THE CORNEAL SHIELD. AT THIS TIME THE SCRUB TECH NOTICED IRREGULAR EDGES ON THE SHIELD. AFTER A CLOSER LOOK RPTR NOTICED A LARGE PORTION MISSING FROM THE EDGE. THE SURGEON REJECTED THE LENS AND ANOTHER ONE WAS OPENED AND REPLACED.
CATHETER INSERTED LEFT ARM. DURING INSERTION PT C/O "FLUSHING". SENSATION LASTING 1-2 MIN. 10A BENADRYL 50 MG FOR "ITCHING" LEFT ARM. 4PM C/O SHORTNESS OF BREATH, "FEELING OUT OF IT". FACIAL FLUSHING. 415PM CATHETER REMOVED, 430PM SYMPTOMS ALMOST GONE. 445PM FLUSHING GONE, NO SHORTNESS OF BREATH.
4 1/2-YEAR-OLD FEMALE UNDERWENT CARDIAC CATH ON 5/3/96. ON 5/5/96 HER MOTHER REPORTED SIGNIFICANT BURNS AND SKIN BREAKDOWN AT ALL ELECTRODE PATCH SITES. THESE WERE TREATED WITH BACITRACIN, CORTISONE CREAM AND VITAMIN E CREAM AND ARE HEALING WELL BUT MAY RESULT IN SCARS. MFR WAS CONTACTED AND STATED THAT ELECTRODES WERE FOR USE ON ADULTS ONLY. THERE IS NO INDICATION ON THE PACKAGING. EXPIRATION DATE 5/8/97.
PT'S VISION IN THE RIGHT EYE WAS NOTED TO BE EXTREMELY BLURRY AT FIRST POST-OPERATIVE EXAM ON 5/2/95. BY 5/30/95, THERE APPEARED TO BE PIGMENT CHANGES IN THE MACULA WITH THE APPEARANCE OF POSSIBLE RETINAL PHOTOTOXICITY RELATED TO LIGHT EXPOSURE DURING THE CATARACT EXTRACTION. BY 6/27/95, VISUAL ACUITY HAD DROPPED IN THE AFFECTED EYE TO COUNTING FINGERS ONLY. WITH BEST CORRECTION, VISUAL ACUITY IMPROVED TO 20/400-AND HAS REMAINED AT THIS LEVEL. PT WAS REFERRED TO RETINA SPECIALIST ON 7/2/95 WHO PERFORMED FLUOROSCEIN ANGIOGRAPHY WHERE EDEMA WAS NOTED IN THE CENTER OF THE RIGHT MACULA. PT WAS BEGUN ON PRED FORTE AND ACULAR EYE DROPS IN AN EFFORT TO RESOLVE THE EDEMA.
ON 5/18/95, FOLLOWING CATARACT EXTRACTION ON THE RIGHT EYE WITH INTRAOCULAR LENS IMPLANTATION, PT CALLED TO REPORT AN OVAL SHAPED SCOTOMA IN THE OPERATED EYE. ON EXAM OF 5/18/95, PT WAS NOTED ON DILATED EXAM TO HAVE FLUID BENEATH THE MACULAR AREA CONSISTENT WITH POSSIBLE PHOTOXICITY TO THE RETINA. REFERRED TO RETINA SPECIALIST. VISUAL ACUITY ON 5/18/95 WAS DOWN TO 20/400 WITH BEST CORRECTION. VOLTARON WAS BEGUN 6/13/84 FOR ITS ANTIINFLAMMATORY PROPERTIES. VISUAL ACUITY IS UP WITH INCREASED BEST CORRECTION TO 20/40 BUT MACULAR PIGMENT CHANGES PERSIST.
PT'S RIGHT EYE EXHIBITED EVIDENCE OF MACULAR PHOTOTOXICITY POSSIBLY RELATED TO LIGHT FROM OPERATING ROOM MICROSCOPE FOLLOWING CATARACT EXTRACTION AND INTRAOCULAR LENS IMPLANTATION WHEN EXAMINED 2 WEEKS AFTER SURGERY. THIS CONTINUED TO IMPROVE WITHOUT INTERVENTION AND THE PT HAS AEQUIRED GOOD VISUAL ACUITY BY 9/5/95.
REMOVAL OF INFECTED RIGHT LEG DIALYSIS GRAFT. PT WITH KNOWN PROBLEMS IN PAST OF PERM CATHETERS NEEDING REPLACED. 1/96 WITH SEPSIS AND REMOVAL OF RIGHT PERM CATHETER. LEFT UPPER CATHETER NON-FUNCTIONING DUE TO SEVERE ISCHEMIA.
MAMMARY IMPLANT DEFLATED, WHEN TAKEN OUT NOTED TO HAVE LINEAR OPENING IN IMPLANT.
FRACTURE TO VENTRICULAR LEAD, LEAD REPLACED. GENERATOR REPLACED FOR INADEQUATE SAFETY MARGINS. OCCASIONAL FAILURE TO CAPTURE - OVERSENSING MITRAL VOLUME REGULATION SYNCOPE.
CATHETER WAS EXPLANTED (DUE TO POOR FUNCTION) AND REPLACED. CATHETER INADEQUATE FOR DIALYSIS. TWO ER VISITS FOR DECLOTTING ARTERIAL CHANNEL. POOR AND INTERMITTENT FLOW PATTERNS.
PT CODING IN SICU - DEFIBRILLATOR WITH PADDLES PLUGGED IN/TURNED ON. CHARGE BUTTON PUSHED - NO CHARGE - PADDLES REMOVED - HANDS OFF ADAPTER ATTACHED -CHARGE BUTTON AGAIN PUSHED - NO CHARGE. BACKUP DEFIB USED - WORKED WELL - NO FURTHER PROBLEMS FOUND WITH DEFIBRILLATOR. INSERVICE WITH INVOLVED STAFF BY CO REP HELD 5/17 TO DISCUSS "USER ERRORS" THAT CAN OCCUR TO PREVENT DEFIBRILLATOR FROM WORKING (CHARGING). ALL QUESTIONS ANSWERED. FURTHER INSERVICE FOR WEEKEND OPTION STAFF. THERE IS A QUESTION AT THIS POINT IN A DESIGN PROBLEM - WE WOULD LIKE TO SEE DISCUSSED (SPECIFICALLY THE YELLOW LEVER WHICH IF NOT ENGAGED PROPERLY CAN RESULT IN THE ABOVE SCENARIO).
PT HAD PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE INSERTED ON 3/18/96 USING THE PULL TECHNIQUE. DEVELOPED LEAKAGE AND CELLULITIS AROUND TUBE SITE. THE PHYSICIAN STATED THAT THE BOLSTER HAD MALFUNCTIONED AND THE TUBE SUBSEQUENTLY BECAME LAX/DISLODGED ALLOWING LEAKAGE AROUND THE TUBE AND INTO THE SUBCUTANEOUS TISSUE CAUSING THE CELLULITIS. THE TUBE WAS REMOVED.
DURING ELECTIVE RIGHT BILATERAL TUBAL CAUTERIZATION AND RESECTION, PER PHYSICIAN, PT'S RIGHT LEG JERKED WHEN CURRENT WAS APPLIED TO INSTRUMENT. OR STAFF DID NOT NOTICE PT JERK. PHYSICIAN SAW NO EVIDENCE OF ANY BOWEL INJURY AND NO BLEEDING WAS NOTED. PT TOLERATED PROCEDURE WELL AND WENT TO RECOVERY ROOM IN SATISFACTORY CONDITION. CAUTERY CABLE IN GOOD CONDITION BUT SENT TO CO FOR EVALUATION.
PT WAS HAVING A CARDIAC CATHETER WHEN A 2" PIECE OF GUIDE WIRE WAS SHEARED OFF AND ENDED UP IN THE RENAL ARTERY. PIECE WAS RETRIEVED WITH NO PT INJURY.
PT WAS RECEIVING INAPPROPRIATE SHOCKS AT HOME AND WAS SENT TO EP LAB. IT WAS FOUND THAT LEAD WAS FRACTURED. A NEW LEAD WAS SURGICALLY IMPLANTED.
DURING USE OF CAUTERY, SPARK IGNITED SURGICAL DRAPES, MELTING NASAL CANNULA AND CAUSING FLASH BURN TO PT'S FACE.
PT WAS UNDERGOING AN AORTIC VALVE REPLACEMENT WITH A BIOLOGICAL PORCINE VALVE. AFTER THE VALVE WAS IMPLANTED, THE CULTURE DONE ON THE VALVE BEFORE IMPLANTATION SHOWED POSITIVE CULTURES. THE CONTAMINATED VALVE WAS THEN REMOVED AND REPLACED WITH A VALVE FROM ANOTHER VENDOR.
PT IN HOME SETTING WITH HOME HEALTH NURSING FOR IV MEDICATION. WHEN HOME HEALTH RN WAS REMOVING TAPE ON DRESSING, THE PICC LINE BROKE AND PULLED APART AT THE EXTERNAL HUB SITE. PT WAS SENT TO ER FOR REMOVAL OF PICC THAT WAS BROKEN AND INSERTION OF A NEW LINE. WITHOUT INTERVENTION, THE SEPARATED PICC LINE HAD THE POTENTIAL TO MIGRATE IN THE VENOUS SYSTEM.
PACEMAKER WAS EXPLANTED DUE TO AN INABILITY TO INTERROGATE THE DEVICE. POSSIBILITY OF LEAD FAILURE.
PT REQUIRED EMERGENCY SURGERY SECONDARY TO AORTORENAL GRAFT FAILURE. GRAFT (IMPLANTED 1984) MATERIAL HAD DETERIORATED AND DILATED CAUSING ANEURYSM RUPTURE. PT REMAINS IN SURGICAL INTENSIVE CARE UNIT, VENTILATOR DEPENDENT, WITH CHRONIC RENAL FAILURE. PROGNOSIS IS GUARDED.
BILATERAL CAPSULAR CONTRACTURE WITH RUPTURE OF IMPLANT ON RIGHT SIDE, REPLACEMENT ON BOTH SIDES.
THE PT WAS A 56-YR-OLD FEMALE WHO INITIALLY HAD BILATERAL BREAST IMPLANTS IN 1986. BECAUSE OF CAPSULAR CONTRACTURE, THE IMPLANTS WERE REPLACED UNDER THE MUSCLE. AT THAT TIME, THE RIGHT IMPLANT WAS FOUND TO BE RUPTURED. THE PT NOTED THE FATIGUE, RIGHT SHOULDER PAIN AND ARTHRALGIA AND MYALGIAS THE LAST THREE YEARS. SHE HAD BEEN DIAGNOSED WITH ATYPICAL RHEUMATOID ARTHRITIS, WITH PREDNISONE AND METHOTREXATE. SHE HAD ALSO BEEN GIVEN THE DIAGNOSIS OF CHRONIC FATIGUE AND FIBROMYALGIA. THE PAST FEW MONTHS THE PT HAS DEVELOPED MEMORY LOSS AND SPEECH PROBLEMS. NEUROLOGY WORKUP WAS NOT REVEALING OF FOCAL CNS LESIONS. ON PHYSICAL EXAMINATION THE PT HAD CLASS IV CONTRACTURES ON BOTH BREASTS. BECAUSE OF THE SEVERITY OF THE SYSTEMIC SYMPTOMS, CHEST WALL PAIN, PREVIOUS RUPTURED IMPLANTS WITH LEFTOVER MAMMARY IMPLANT MATERIAL IN THE RIGHT AXILLA, IT WAS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS AND DO A TOTAL CAPSULECTOMY INCLUDING SUBMUSCULAR AND SUBMAMMARY, AS WELL AS TO REMOVE THE MAMMARY IMPLANT MATERIAL IN THE RIGHT AXILLA.
THIS 45-YR-OLD FEMALE HAD SILICONE GEL BREAST PROSTHESIS IMPLANTED TWICE IN 1989. THE MFR OF THE IMPLANTS IS UNKNOWN TO THIS REPORTING FACILITY. THE PT PRESENTS SIGNS AND SYMPTOMS OF CAPSULAR CONTRACTURE, RETRACTED LEFT NIPPLE AND WISHES IMPLANT REPLACEMENTS. GROSS EXAM: BOTH IMPLANTS ARE PARTIALLY DEFLATED.
THIS 38-YR-OLD FEMALE UNDERWENT BILATERAL SILICONE GEL BREAST PROSTHESIS IMPLANTATION LAST IN 5/84. DUE TO SPECIFIC CHANGES, THE PT WISHES TO HAVE THE IMPLANTS EXCHANGED FOR SALINE FILLED IMPLANTS. GROSS EXAM: BOTH IMPLANTS ARE DISRUPTED AND EXUDE STICKY, STRINGY, VISCOUS MATERIAL.
THE PT IS A 42-YR-OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 1987 USING ANOTHER CO'S IMPLANTS. THESE BECAME HARD IMMEDIATELY WHICH DID NOT RESPOND TO CLOSED CAPSULOTOMY UNDER ANESTHESIA RESULTING IN ANOTHER REPLACEMENT USING POLYURETHANE IMPLANTS IN 1988. SINCE THAT TIME SHE HAS DEVELOPED FATIGUE, HAIR LOSS, RASHES AND MYALGIAS AS WELL AS PAIN IN THE BREASTS. SHE HAS SEVERE CAPSULAR CONTRACTURE CLASS IV IN BOTH BREASTS. IN ADDITION XEROGRAM AND ULTRASOUND DEMONSTRATE EXTENSIVE SILICONE MIGRATION INTO THE LYMPH NODES INCLUDING THE AXILLARY AS WELL AS THE INTERCOSTAL NODES.
THE PT IS A 44-YR-OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 1979 USING IMPLANTS DUE TO POSTPARTUM ATROPHY. BOTH IMPLANTS GOT HARD IMMEDIATELY. THE LEFT IMPLANT HAS BECOME VERY PAINFUL WITH RADIATION OF PAIN TO THE AXILLA, MEDIAL LEFT ARM AND MEDIAL LEFT ELBOW. SHE HAS CLASS 4 CONTRACTURE ON BOTH SIDES. XEROGRAM AND ULTRASOUND DEMONSTRATE A RIGHT INTACT IMPLANT, BUT A LEFT POSSIBLE RUPTURE. THERE IS CALCIFICATION OF THE BIOLOGICAL CAPSULES ON BOTH SIDES. BECAUSE OF SIGNIFICANT LOCAL PAIN, SEVERE CONTRACTURE AND PROBABLE RUPTURE ON THE LEFT, AND CLACIFICATION OF THE BIOLOGICAL CAPSULE IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS. TOTAL CAPSULECTOMY IS ALSO NECESSARY BECAUSE OF THE CALCIFICATION OF THE BIOLOGICAL CAPSULE PROBABILITY AS WELL AS PAIN.
INSTRUMENT TIP "L" HOOK BROKE OFF INSIDE PT DURING LAPAROSCOPIC PROCEDURE; X-RAY VERIFIED TIP INSIDE PT; RE-OPENED PT TO REMOVE TIP. MFG DATE CODE, KP = 10/95 (IN WARRANTY). PROCEDURE REQUIRED APPROX 5 HRS TO CONDUCT, INCLUDING RETRIEVAL OF FOREIGN BODY. POST-OP RECOVERY UNEVENTFUL TO THIS POINT. CAUSATION OF FBO UNDETERMINED AT PRESENT.
EMS PERSONNEL WERE DELIVERING 360 JOULES TO PT WHO WAS LYING ON FLOOR (PT HAD URINATED THEREFORE CARPET WAS WET) AND RECEIVED A SHOCK. IT IS ALSO THOUGHT THAT PT'S HAND WAS TOUCHING THE EMT'S KNEE.
PORT WAS PLACED ON 4/18. PORT DID NOT WORK FOR DELIVERY OF CHEMO'S, IT "SEEMED PLUGGED." REPLACEMENT OF "PORT" IN OR ON 4/19/96.
CATHETER WAS PLACED. IMMEDIATELY, PT BECAME SHORT OF BREATH, FACE BECAME RED AND PT COMPLAINED OF INCREASED NAUSEA AND DIZZINESS. LINE REMOVED IMMEDIATELY. PT RETURNED TO BASELINE WITHIN 5 MINS.
DURING REMOVAL OF PORT, UNDER FLUOROSCOPY IT WAS NOTICED THAT THE DISTAL TIP OF THE CATHETER WAS BROKEN OFF. PT REQUIRED SECOND PROCEDURE IN CATH LAB TO SNARE LOOSE CATHETER PIECE FROM THE RIGHT VENTRICLE.
A 3.0 STENT WAS TO BE DEPLOYED IN MID-LAD. STENT CATHETER WAS INSERTED BUT THE BALLOON WOULD NOT INFLATE. WENT UP TO 10 ATM. THE STENT WOULD NOT COME OFF THE BALLOON AND THE STENT WAS NOT DEPLOYED. ANOTHER CATHETER WAS USED. THERE WAS NO HARM TO THE PT.
PT SUSTAINED 8MM, THIRD DEGREE BURN TO RIGHT UPPER LIP DURING LASER PROCEDURE. IT APPEARS THAT THE SET SCREW HAD LOOSENED ALLOWING THE MIRROR TO SPIN.
PT IS DISSATISFIED WITH SIZE OF MAMMARY PROSTHESES; DESIRED SMALLER SIZE.
RUPTURED IMPLANT LEFT SIDE AND CAPSULAR CONTRACTURE. REMOVED IN SURGERY ON 5/2/96.
PHYSICIAN WAS EVALUATING A CO PROSTHESIS AND INSTRUMENTS IN A TOTAL HIP REPLACEMENT. 13MM MODULAR DISTAL BROACH TIP WAS NOT RETRIEVABLE FROM THE RIGHT FEMORAL CANAL DURING SIZING INSTRUMENTATION. FEMORAL PROSTHESIS WAS CEMENTED.
VENTILATOR WAS NOT WORKING AND ALARM SOUNDED BUT PT FOUND CYANOTIC.
PROBLEMS HAVE BEEN ENCOUNTERED WITH T CONNECTOR COMING LOSE AND T CONNECTOR LEAKING AT THE HUB.
PT WAS HAVING AN ATRIAL SEPTAL DEFECT REPAIR ON 5/3/96. WHEN ON BYPASS A LEAK NOTICED. FLUID APPEARED IN THE GAS CHAMBER. NO PT INJURY.
PT HAVING OPEN HEART SURGERY; PRIOR TO INITIATION OF BYPASS, FLUID APPEARED AT THE TOP OF THE GAS CHAMBER OF OXYGENATOR (BLOOD TO GAS LEAK). OXYGENATOR CHANGED. NO HARM TO PT.
THE PT IS A 41-YR-OLD WOMAN WHO HAD BILATERAL BREAST AUGMENTATION IN 1986 USING THE DOUBLE LUMEN IMPLANT UNDER THE BREAST. TWO YEARS POSTOPERATIVELY, IN 1988, THE PT DEVELOPED DRY EYES, DRY MOUTH, AND VAGINAL DRYNESS. SHE THEN DEVELOPED DIFUSE ARTHRALGIAS AND FATIGUE FOR TWO WEEKS IN 1988. SHE WAS DIAGNOSED WITH SJOGREN'S DISEASE AND THEN AT THAT TIME SHE ALSO DEVELOPED RHEUMATIC ARTHRITIS REQUIRING PREDNISONE METHOTREXATE FOR TREATMENT. AT THE PRESENT TIME SHE HAS BOTH RHEUMATOID ARTHRITIS AND SJOGREN'S DISEASE. ON PHYSICAL EXAMINATION SHE HAS A CLASS 4 CONTRACTURE ON THE LEFT AND CLASS 3 CONTRACTURE ON THE RIGHT. BECAUSE OF POTENTIAL ASSOCIATION OF CONNECTIVE TISSUE DISEASE WITH HER BREAST IMPLANTS, THE PT WOULD LIKE IMPLANTS REMOVED TO SEE IF SHE CAN GO INTO REMISSION AS FAR AS HER CONNECTIVE TISSUE DISEASES ARE CONCERNED.
UNABLE TO TIGHTEN CONNECTION TO CATHETER TO STOP LEAK. PROBLEM RESOLVED WITH NEW EQUIPMENT.
INFUSION HOOKED TO PUMP. RN HOOKED PT TO PUMP AND BEGAN INFUSION. SOME FLUID NOTED AT TIME BUT DISREGARDED. PT CALLED NURSING AGENCY APPROX 30 MINS LATER - PUMP LEAKING AT FILTER.
ADDITIONAL INFO RECEIVED FROM MFR ON 09/10/1998: SINCE THE HOSPITAL WOULD NOT RELEASE THE SAMPLE FOR CO EVALUATION, THE EXACT CAUSE OF THE COMPLAINT REMAINS UNDETERMINED. THE REPORTED INFO SUGGESTS THAT A FRACTURE OF THE STAINLESS STEEL CENTRAL LUMEN OCCURRED. SUCH AN OCCURENCE IS VERY RARE, BUT WAS PROBABLY INFLUENCED BY THE FACT THAT THE CATHETER WAS NOT SUTURED AT THE BIFURCATION AREA.
TIP BROKE OFF WHILE GETTING IT READY TO PUT IN PT. NEW KIT OPENED.
BECTON DICKINSON AND CO. 1 BECTON DR, FRANKLIN LAKES, NJ 07417-1884. OUR INVESTIGATIONS ON THIS CONDITION INDICATE THAT THIS TYPE OF DAMAGE MAY RESULT FROM INTERNAL STRESS THAT OCCURS DURING THE MOLDING PROCESS. INTERNAL STRESS PREDISPOSES THE BARREL TO FRACTURES FROM IMPACTS THAT MAY OCCUR IN TRANSIT OR DURING HANDLING. IN USE THESE FRACTURES CAN OPEN RESULTING IN LEAKAGE. THIS CONDITION OCCURS ONLY ON A SMALL PERCENTAGE OF PARTS AND IS DIFFICULT TO DETECT. OUR RESEARCH AND DEVELOPMENT DEPT IS CURRENTLY WORKING TO IMPLEMENT AN IMPROVED SYRINGE MATERIAL THAT IS EXPECTED TO REDUCE THE FREQUENCY OF THIS DEFECT.
QUESTIONABLE QUALITY CONTROL ISSUE WITH COAGULATION TUBES. BLOOD VOLUME IN TUBE NOT ACHIEVED WITH BLOOD DRAIN DUE TO INSUFFICIENT VACUUM. REQUIRES RE-DRAW FROM PT.
IV TUBING CAME APART AT THE Y-CONNECTION WITH PORT.
CLEAR TUBING BROKEN OFF AT WHITE PLASTIC JUNCTION.
THE DRILL WAS ACTIVATED AFTER LOADING. THE DRILL SPUN THE DRILL BIT SO FAST IT CAUSED THE DRILL BIT TO BREAK. THIS OCCURRED AT 80% POWER. AGAIN THE SAME PROBLEM OCCURRED AT 40% POWER. THIS OCCURRED IN REPETITION, EVEN WITH NEW DRILL BITS. NO INJURY OCCURRED, HOWEVER, THIS IS A VERY DANGEROUS SITUATION.
INADEQUATE SENSING NOTED ON TTM. PT BROUGHT IN FOR CENTER VISIT. OVER-SENSING NOTED ON ALL SETTINGS. PT SCHEDULED FOR REPLACEMENT 5/2/96. A DIFFERENT MODEL BY THIS MFR IS ON SAFETY ALERT.
THE PT IS A 46-YR-OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 1981 USING ANOTHER CO'S DOUBLE LUMEN BREAST IMPLANTS. THE PT DEVELOPED HAIR LOSS IN 1982 AND 1983. SHE ALSO DEVELOPED SLEEP PROBLEMS, PHOTOSENSITIVITY, RASH, ARTHRALGIAS IN THE HANDS, HIPS, KNEES, FEET AND SHOULDER AND MORNING STIFFNESS, AND CHRONIC FATIGUE. SHE ALSO HAD A HISTORY OF HASHIMOTO'S THYROIDITIS AND PRESENTLY HAS BURNING PAIN IN THE LEFT BREAST WHICH STARTED THREE YEARS AGO. XEROGRAM AND ULTRASOUND DEMONSTRATE A DEFINITIVE LEFT INTRACAPSULAR RUPTURE AND AN INTACT RIGHT DOUBLE LUMEN IMPLANT. BECAUSE OF SIGNIFICANT SYMPTOMS, RUPTURE OF THE LEFT IMPLANTS, ASSOCIATED WITH PAIN OF THE LEFT IMPLANT, IT IS MEDICALLY NECESSARY TO REMOVE BOTH IMPLANTS. TOTAL CAPSULECTOMY IS NECESSARY BECAUSE OF SYMPTOMS AND BECAUSE OF RUPTURE.
THE PT WAS A 47-YR-OLD FEMALE WHO HAD A BILATERAL SUBCUTANEOUS MASTECTOMY IN 10/87. IN 4/88 THE PT HAD RECONSTRUCTION USING POLYURETHANE COVERED SILICONE GEL FILLED BREAST IMPLANTS. APPARENTLY, THERE WAS A LOT OF PAIN ON THE RIGHT SIDE WITH BURNING PAIN. THE PT THEN DEVELOPED WEAKNESS IN THE RIGHT ARM AND FATIGUE. THE PT HAD TO QUIT WORK IN 1991 DUE TO FATIGUE. BASED ON SYSTEMIC SYMPTOMS, THE PT HAS BEEN RECOMMENDED TO REMOVE BOTH IMPLANTS.
THE PT WAS A 52-YR-OLD FEMALE WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 1980, USING 200CC GEL FILLED BREAST IMPLANT. EIGHT YEARS AGO, LEFT BREAST BEGAN TO BE SORE ESPECIALLY WITH EXERCISE. SHE THEN DEVELOPED STIFFNESS IN VARIOUS JOINTS, AS WELL AS PLANTAR FASCITIS AND MUSCLE PAIN. THE PT 2.5 YEARS AGO ALSO DEVELOPED WEAKNESS IN THE HANDS AND ARTHRALGIAS IN THE SHOULDER AND FINGERS. THE PT NOTED FATIGUE SINCE 1994. ON PHYSICAL EXAMINATION, THE PT HAD CLASS IV CONTRACTURE ON THE RIGHT AND CLASS III ON THE LEFT, WITH TENDERNESS ON PALPATION. BECAUSE OF THESE SYMPTOMS, IT WAS RECOMMENDED TO HER TO HAVE THESE IMPLANTS REMOVED.
THE PT IS A 47-YR-OLD WOMAN WHO HAD BILATERAL BREAST AUGMENTATION IN 1984 USING 200CC BREAST IMPLANTS. BOTH IMPLANTS BECAME HARD, AND THE PT HAD CLOSED CAPSULOTOMIES, ON THE LEFT SUCCESSFULLY, HOWEVER, THE DR WAS UNABLE TO BREAK THE RIGHT CAPSULE. SINCE THAT TIME THE RIGHT SIDE HAS GOTTEN VERY HARD WITH OCCASIONAL SHOOTING PAINS. SHE ALSO COMPLAINS OF MORNING STIFFNESS IN VARIOUS JOINTS, ROSACEA ON THE FACE. XEROGRAM AND ULTRASOUND DEMONSTRATE A DEFINITIVE LEFT INTRACAPSULAR RUPTURE AND A PROBABLE RUPTURE ON THE RIGHT. BECAUSE OF RUPTURE CAPSULAR CONTRACTURE, IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS.
TWO DEGREE BURN OF EAR AURICLE APPROX 5M X 2M. NOTED AT POST OP VISIT 4/10. MD FEELS OCCURRED USING ENT MICROSOCPE. EAR SPECULUM HEATED CAUSING BURN ALTHOUGH SKIN INTEGRITY AFTER CASE NOTED INTACT. REDNESS AND BLISTERING NOTED NEXT DAY.
DELAMINATION OF POLY SURFACES. LACK OF INGROWTH TO PATELLA AND EXCESSIVE WEAR TO BOTH TIBIAL INSERT AND PATELLA. REMOVED TIBIAL INSERT AND PATELLA AND REPLACED.
A FIXATION PIN HEAD WAS REMOVED FROM THE FRAME AND WAS DISCOVERED BY THE HOSP TO HAVE THE TIP CHIPPED OFF. THE HOSP COULD NOT DETERMINE IF THIS HAPPENED BEFORE, DURING, OR AFTER THE PROCEDURE. IT WAS LEARNED ON 5/7/96 THAT THE PT WILL UNDERGO MRI ON HIS 6 WEEK CHECKUP TO CHECK FOR ANY POSSIBLE DEBRIS.
SURGEON REMOVED LOOSE PATELLA AND CEMENTED ALL POLY PATELLA. SURGEON TOOK OUT 7MM WORN INSERT AND REPLACED WITH 9MM INSERT.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TIP OF THE DISSECTION CANNULA BROKE OFF. PROCEDURE CONVERTED TO OPEN SURGERY AND THE BROKEN PIECE WAS REMOVED.
DEVICE LEAKED BEFORE IMPLANTATION. A BACK-UP DEVICE WAS USED; NO PT INJURY.
PT PRESENTED WITH PAIN. X-RAY REVEALED SOME WEAR. ARTHROSCOPY PROVIDED EVIDENCE WEAR WAS IN FACT PRESENT. KNEE WAS OPENED, PATELLA AND TIBIAL INSERT WERE EXCHANGED.
FACILITY ALLEGED BLOOD LEAK DURING TREATMENT. NO PT INJURY REPORTED. EBL 150CC.
THREE DAYS POST PLACEMENT THE PT RETURNED WITH INFLAMMATION. A LAPAROTOMY WAS PERFORMED AND IT WAS NOTED THE PT DEVELOPED PERITONITIS. THE EXTERNAL BOLSTER LOOSENED FROM THE SKIN ALLOWING FLUID TO LEAK INTO THE STOMA. THE PT WAS ADMITTED FOR OBSERVATION. THE PT HAD OTHER SERIOUS HEALTH PROBLEMS. FOLLOW-UP WITH THE PHYSICIAN REVEALED THE LAPAROTOMY WAS DIAGNOSTIC IN NATURE TO DETERMINE CAUSE OF INFLAMMATION. WHEN NO CAUSE COULD BE ATTRIBUTED IT WAS BELIEVED THE INFLAMMATION WAS DUE TO THE LOOSE EXTERNAL BOLSTER.
IMPLANT WAS PLACED IN A SURGICAL EXTRACTION SITE, TOOTH #4, ON 4/5/96. (TOOTH EXTRACTION WAS DONE ON 11/24/95). IMPLANT DID NOT FIT SOLIDLY IN EXTRACTION SITE AND WAS THEREFORE REMOVED AND REPLACED WITH A 10X4.0MM IMPLANT.
REVISION (R) ARTHROPLASTY. LOOSE TOTAL HIP (COMPETITOR HIP).
BALL ON END OF PROBE BROKE OFF. FOREIGN BODY HAS NOT BEEN RETRIEVED.
PT WAS COMATOSE AND ON PERMANENT VENT SUPPORT. CHEST X-RAY OF PT AT 9:15 5/11/96 WAS NORMAL, CHEST X-RAY 5/21/96 AT 23:15 SHOWED LEFT SIDE PNEUMOTHORAX. FILTER EXAMINED AT THIS TIME AND WAS FOUND TO HAVE EXCESSIVELY HIGH RESISTANCE TO FLOW OF AIR FROM A STANDARD AMBU BAG. SUBSEQUENTLY A SECOND FILTER ON ANOTHER PT WAS IDENTIFIED AS HAVING HIGH RESISTANCE WHEN A VENT ALARM INDICATED A PROBLEM. BOTH FILTERS RETURNED TO CO WITH A CO FIELD REVIEW REPORT.
THERE WAS A BLOOD LEAK ON A FIRST USE DIALYZER. EBL >100CC. THE SYSTEM WAS DISCARDED AND A NEW SYSTEM SET UP AND TREATMENT WAS RESUMED WITHOUT FURTHER INCIDENT.
DURING A BLADDER STONE REMOVAL PROCEDURE, THE JAW OF THE GRASPER BROKE OFF. BROKEN PIECE WAS RETRIEVED BUT STONES WERE NOT TOTALLY REMOVED. PT STAYED OVERNIGHT IN THE HOSP FOR OBSERVATION.
PUMP PROGRAMMED CORRECTLY TO DELIVER CORRECT DOSE OF ANTIBIOTICS EVERY 8 HRS DURING A 24 HOUR PERIOD. THE ENTIRE 24 DEGREE DOSE INFUSED AT ONCE.
SUPERFICIAL CRACKS IN ANTERIOR SURFACE OF LENS. FORTUNATELY NOT CENTRAL. USED SAME MFR'S FOLDERS AS ADVISED BY CO.
BALLOON CAME OFF CATHETER DURING EMBOLECTOMY. THERE WAS BLEEDING AND AN ANGIOGRAM WAS PERFORMED WHICH DID NOT REVEAL ANY FILLING DEFECT.
DR WENT TO REMOVE FOLEY THAT HAD BEEN INSERTED IN ER AND BALLOON WOULD NOT DEFLATE.
DURING THE PLACEMENT OF 1 STIMULATOR IN THE DORSAL COLUMN THE LEAD DISAPPEARED FROM VIEW ON THE C-ARM SCREEN. THROUGH THE USE OF FLUOROSCOPY THE LEAD WAS NOTED HIGH UP IN THORACIC AREA. MD UNABLE TO RETRIEVE, NEUROSURGEON CONSULTED AND MFR WAS CALLED. NO SURGICAL INTERVENTION WAS RECOMMENDED.
CANNOT GET THE CAP OFF THE HEPARIN LINE EVEN USING CLAMPS.
THE CATHETER DID NOT INFLATE WHEN AUGMENTED BY IABP MACHINE OR MANUALLY BY PHYSICIAN. THE IABP MACHINE WAS CHECKED OUT BY BIOENGINEERS AND DEEMED IN WORKING ORDER.
PT NOT ABLE TO RECEIVE IV THERAPY (ANTIBIOTIC) BECAUSE DEVICE WOULD NOT INFUSE PRODUCT.
PUMP NOT FUNCTIONING. HAS NOT BEEN USED FOR OVER A YEAR ACCORDING TO PT. NO INJURY.
SPINAL CORD PULSE GENERATOR NOT FUNCTIONING. PT REQUESTED REMOVAL/REPLACEMENT WITH NEW ONE. SCS CORD SEEMS TO BE BROKEN. NO INJURY TO PT.
NON-FUNCTIONING SPINAL CORD STIMULATOR-GENERATOR. NO INJURY TO PT.
ATRIAL LEAD IMPEDANCE FELL TO LESS THAN 250 OHMS. POSSIBLE INSULATION FAILURE. EXPLANTATION ABANDONED.
PT DESIRED SUB-PECTORAL CONVERSION TO MASTOPEXY - BILATERAL.
CONTAINER HAS A LEAK. APPARENTLY CAUSED BY CREASING DURING THE MFG PROCESS. PRINTING OBLITERATED ALONG CREASE.
UNABLE TO PROCESS MAMMOGRAPHY X-RAY FILMS DUE TO POOR DESIGN. THE PROCESSOR IN QUESTION WAS INSTALLED IN 6/94, SINCE THEN NUMEROUS PROBLEMS HAVE OCCURRED. A DISTINCT FLAME PATTERN ON FILM WAS FROM A POOR DESIGN IN THE DEVELOPER RECIRCULATION SYSTEM. ROLLER MARKS WERE BEING LEFT ON FILMS FROM POORLY DESIGNED DEVELOPER ROLERS AND CROSSOVER RACKS WHICH MADE RADIOGRAPHS UNACCEPTABLE BY ACR. DEFECTIVE TEMP CONTROL MICROPROCESSOR BOARD RENDERED THE PROCESSOR UNABLE TO PROCESS MAMMOGRAPHY FILMS. THE LAST PROBLEM THAT WAS ENCOUNTERED WAS AN ICICLE PATTERN ON THE FILM THAT COULD NOT CORRECT, AND WAS CAUSED BY THE FAULTY RACK SYSTEM. SINCE THIS UNIT WAS INSTALLED IN 6/94 THIS UNIT HAS YET TO PROCESS AN ACCEPTABLE X-RAY FILM. CO SVC AND REPAIR PERSONNEL HAVE MADE NUMEROUS ATTEMPTS TO REPAIR THIS UNIT WITHOUT SUCCESS.
THE WHEELCHAIR WAS ISSUED TO A CUSTOMER APPROX ONE MONTH AGO. CUSTOMER REPORTED TO THE CENTER THE WEEK OF AUGUST 1ST INDICATING THAT HIS BRAKES NEEDED TO BE TIGHTENED. INSPECTION BY THE WHEELCHAIR REPAIR TECH FOUND THAT HE WAS UNABLE TO TIGHTEN THE BRAKES. THE BRAKE ASSEMBLY NEEDED TO BE REPLACED. THE ASSEMBLY HAD BEEN TIGHTENED ONCE AND AFTER NORMAL USE OF APPROX ONE MONTH THE ASSEMBLY NEEDED TO BE REPLACED. OTHER WHEELCHAIRS THAT HAVE BEEN ISSUED TO VETERAN CUSTOMERS HAVE HAD NUMEROUS PROBLEMS INCLUDING THE SEAT RAIL LOCKING BRACKET BREAKING DUE TO THE MATERIALS USED IN FABRICATING IT. A SITUATION INVOLVING FRONT CASTORS BREAKING AT THE CENTER. A NUMBER OF COMPLAINTS THAT "ALLIGNMENT" IS PULLING THE WHEELCHAIR TO EITHER THE LEFT OR RIGHT, MAKING IT EXTREMELY DIFFICULT TO PUSH. RPTR HAS CONCERNS REGARDING THE LEGREST MOUNTING BRACKETS WHICH ARE SECURED BY NUTS AND BOLTS AND NOT WELDED AS MOST MFRS' PRODUCTS USE.
FELL AT HOME SUSTAINING A DISPLACED RIGHT FEMORAL NECK FRACTURE. 15-20 MIN AFTER BONE CEMENT INJECTED, PT WENT INTO RESPIRATORY ARREST. HE WAS RESUSCITATED AND ADMITTED TO SICU ON A VENTILATOR.
COMPLAINANT COMPARED TEST STRIPS TO ANOTHER BRAND. ON 5/24/96 TEST STRIPS RESULTS WERE AM - 98, NOON - 132, DINNER - 208, AND PM - 114; OTHER BRAND AM - 222, NOON - 87, DINNER - 243, AND PM - 230. ON 5/28/96 AM - 126, NOON - 220, DINNER - 150, AND PM - 128; THE OTHER BRAND AM - 182, NOON - 238, DINNER - 201, PM - 235. COMPLAINANT SAW DR TODAY WHO ORDERED A BLOOD TEST, AND TOLD PT HER INSULIN WOULD BE ADJUSTED ACCORDINGLY. COMPLAINANT SAID DR HAS BEEN LOWERING HER INSULIN PRESCRIPTION BASED ON THE TEST STRIP RESULTS SINCE SHE BEGAN USING THIS PRODUCT (APPROX SIX MONTHS). RPTR EXPECTED TO HAVE SYMPTOMS WHEN HER BLOOD SUGAR WAS 87, BUT HAS NOT NOTICED ANY SYMPTOMS. THE COMPLAINANT DOES NOT FEEL THE STRIPS ARE ACCURATE, BUT DOES NOT WANT TO PURSUE THIS COMPLAINT WITH THE DISTRIBUTOR OR THE MFR.
THE FOOT CONTROL UNITS ON THE DENTAL CHAIR ARE EXTREMELY FRAGILE AND SUBJECT TO DAMAGE EASILY. THE TYPES OF DAMAGE INCLUDE BROKEN BUTTONS, SWITCHES, CRACKED CASES AND CONNECTING CORDS PULLING OUT OF THE STRAIN RELIEF. THE UNUSUALLY HIGH LEVEL OF OCCURRENCES HAS AT TIMES RENDERED AS MANY AS 25% OF THE UNITS IN ONE CLINIC UNUSABLE. THE AMOUNT OF TIME TO OBTAIN REPLACEMENT WARRANTY PARTS FROM THE MFR IN MOST CASES HAS EXCEEDED 30 DAYS.
NEEDLES DO NOT APPEAR TO BE SHARP ENOUGH CAUSING PT DISCOMFORT WHEN BEING USED.
GAMMA CAMERA HEAD #2 SHIFTED DOWNWARD STRIKING THE PT IN THE ABDOMEN. THE PROBLEM WAS BROKEN BALL SCREW SHAFT OF THE GAMMA CAMERA HEAD #2 ASSEMBLY. THERE IS RADIAL DRIVE MOTOR GEAR BOX ASSEMBLY WHICH TURNS THE BALL SCREW SHAFT TO LIFT GAMMA CAMERA HEAD ASSEMBLY.
UPON ATTEMPTING TO USE THE DEVICE, THE SURGEON NOTICED THAT THE STAPLES APPEARED TO BE IN A PUSHED OUT POSITION. DEVICE DID NOT FIRE AND NO INJURY WAS CAUSED TO THE PT.
SEVERAL INACCURATE READINGS OBTAINED. METER COMPARED VISUALLY; ANOTHER METER AND FINALLY A HOSP LAB METHOD SAMPLE OBTAINED A SECOND METER OF SAME MODEL REPLACED IT AND AGAIN SEVERAL INACCURATE READINGS VERIFIED BY VISUAL METHOD, ANOTHER BRAND METER AND A LAB DRAW.RPTR FEELS THE MFR MUST REEVALUATE ITS QUALITY CONTROL. IT IS TOO DANGEROUS FOR PT'S HEALTH.
THESE SPECIMEN CUPS ARE CRACKED. IT IS NOT NOTICEABLE UNTIL A PT HAS USED ONE AND IT STARTS LEAKING. EVERY THIRD CUP IS DEFECTIVE.
ON OCT, 94 RPTR HAD SEVENTH BACK SURGERY. DR TOLD HER THAT HE WOULD USE "PEDICLE SCREWS" THAT ARE NOT APPROVED BY FDA FOR THIS TYPE OF OPERATION. SHE WAS GIVEN THIS INFO VERBALLY BY HER DR. SHE GAVE WRITTEN CONSENT TO DO THE OPERATION BUT SHE DOES NOT HAVE WRITTEN CONSENT FOR THE PEDICLE SCREWS. THE PEDICLE SCREWS WERE IMPLANTED IN HER (L-4, L-5, AND S-1 VERTEBRAE. ONE OF THE SCREWS LATER BROKE IN HALF. DURING DR'S REQUESTED X-RAYS (BENDING X-RAYS) IT WAS DISCOVERED THAT ONE OF THE SCREWS WAS BROKEN IN HALF. RPTR FEELS THAT IF THE DR DID THE OPERATION AS A STUDY, SHE SHOULD HAVE BEEN GIVEN A PERMISSION/WRITTEN RELEASE TO SIGN. SHE ALSO DOES NOT FEEL THAT HER DR HAS REPORTED THIS INCIDENT TO THE FDA.
VENOUS HEADER CRACKS CAUSING BLOOD LOSS. ALSO, SOME WERE FOUND BEFORE BEING USED.
CUSTOMER APPLIED PRODUCT TO A 1ST DEGREE BURN. AFTER APPLYING VARIOUS REMEDIES, AND WITHIN 6 HRS, WHEN THE PRODUCT WAS REMOVED, IT TOOK THE SKIN OFF. AREA INVOLVED WAS ABOUT 2 INCHES. PRODUCT WAS USED PER PACKAGE INSTRUCTION.
IABP CATHETER GUIDE WIRE WOULD NOT ADVANCE THROUGH LUMEN. BALLOON PARTIALLY INFLATED WHEN SALINE FLUSHED THROUGH LUMEN BY PHYSICIAN.
PT HAD PROBLEM WITH PUMP ALARMING IN THE MIDDLE OF NIGHT, BUT WAS ABLE TO GET PUMP TO WORK FOR THE REST OF HIS INFUSION. RPTR REPLACED PUMP THE NEXT DAY AND WHEN TESTED, A PROBLEM WAS FOUND WITH THE BATTERY.
FLUID WILL NOT PASS THROUGH THE DRIP CHAMBER IN 4 IV TUBINGS. OTHER INCIDENTS HAVE BEEN REPORTED, BUT SAMPLES AND LOT NUMBERS ARE NOT AVAILABLE.
UNABLE TO DEFLATE FOLEY CATHETER BALLOON IN ORDER TO REMOVE FOLEY CATHETER. UROLOGY FINALLY GOT BALLOON TO DEFLATE ENOUGH TO REMOVE.
SILICONE BREAST IMPLANTS: 8/24/82. IMPLANTS REDONE: 8/31/88 AND 9/15/89. WENT FROM PERFECT HEALTH AND VERY ATHLETIC TO SEVERE HEALTH PROBLEMS. HAVE BEEN CERTIFIED AS DISABLED BY SOCIAL SECURITY. SYMPTOMS INCLUDE EXTREME FATIGUE, INTESTINAL PROBLEMS, ARTHRITIS, HAIR LOSS (50%), DEPRESSION, NAUSEA, FEVERS OF UP TO 101 ALMOST DAILY, MEMORY AND COGNITIVE IMPAIRMENT, DIZZINESS AND DISORIENTATION, TREMORS, LOSS OF BALANCE, LUNG AND BREATHING DIFFICULTIES (REQUIRING USE OF OXYGEN), BLADDER PROBLEMS, TINGLING IN HANDS AND FINGERS, BURNING SENSATIONS UNDER SKIN, BLURRED VISION, MOUTH AND SCALP ULCERS, DISFIGURING RASHES ON CHEST AND NECK. DIAGNOSED WITH ATYPICAL CONNECTIVE TISSUE DISEASE WITH LUPUS-LIKE SYMPTOMS. NOW CAN NO LONGER WORK.
RPTR'S RIGHT IMPLANT RUPTURED ON 5/3/96. ON 6/17/96 SHE WENT BACK TO SURGERY TO REPLACE BOTH OF HER IMPLANTS.
RPTR'S RIGHT IMPLANT RUPTURED ON 5/3/96. ON 6/17/96 SHE WENT BACK TO SURGERY TO REPLACE BOTH OF HER IMPLANTS. ON 6/6/94 THE IMPLANTS DEFLATED.
THREE DAYS AFTER HERNIA REPAIR SURGERY USING WIRE MESH AND TITANIUM SCREWS, A SMALL LUMP APPEARED ON RPTR'S ABDOMEN. IT WAS PAINFUL AND GRADUALLY BECAME LARGER. BY THE END OF MARCH A SECOND LUMP APPEARED BESIDE THE FIRST ONE. OPERATING SURGEON WAS NOT CONCERNED ABOUT THE LUMP. A CONSULTING SURGEON DID ABDOMINAL X-RAYS AND DISCOVERED 13 SCREWS. 4 WERE EXPLANTED AS THEY HAD BECOME IMBEDDED IN RPTR'S ABDOMINAL WALL. THE SURGEON KEPT 2 SCREWS AND THE PT HAS 2. RPTR DISCUSSED PROBLEM WITH THE CO SALES REP WHO TOLD HER THAT THE SCREWS WERE ONLY INTENDED TO HOLD THE MESH IN PLACE FOR THREE DAYS WHILE IT INTEGRATED. THE REP STRONGLY ENCOURAGED THE PT TO HAVE THE SCREWS EXPLANTED AS THE CO WAS CONCERNED ABOUT INFECTION, 9 OF 13 SCREWS REMAIN IMPLANTED.
DURING 6/21/96 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG), APPROX 1 INCH OF DISTAL TIP OF OUTER SHEATH OF ANGIOCATHETER SHEARED OFF WHILE IN PT'S STOMACH. NO ADVERSE PT EFFECT. PROCEDURE COMPLETED WITH ANOTHER PEG KIT.
PT UNDERWENT HIP SURGERY ON 4/10/96. ON 4/22/96 A FEEDING TUBE WAS INSERTED IN PT. X-RAY FOR TUBE PLACEMENT SHOWED BRONCHIAL PLACEMENT. TUBE WAS REMOVED. INTUBATION WAS RE-ATTEMPTED. PT EXPIRED PRIOR TO SECOND PLACEMENT X-RAY.
PT HAD REMOVAL OF SILICONE GEL IMPLANTS DUE TO PAIN AND CAPSULAR CONTRACTURE. BOTH IMPLANTS WERE FOUND TO BE RUPTURED AND WEIGHED 300 G AND 210 G - RIGHT AND LEFT RESPECTIVELY.
PT HAD AN AREA OF MICROCALCIFICATION IN UPPER LEFT BREAST. BIOPSY REVEALED INVASIVE LOBULAR CARCINOMA IN A SMALL AREA WITH EXTENSIVE INSITU LOBULAR CARCINOMA THROUGHOUT THE SPECIMEN. IT WAS FELT THAT MASTECTOMY WAS INDICATED AND THE PT ELECTED TO HAVE BILATERAL MASTECTOMY FOR THIS CONDITION WHICH IS FREQUENTLY BILATERAL. NEITHER IMPLANT WAS RUPTURED AND THEY HAD IDENTIFIERS OF CO 200 CC.
SPONTANEOUS DEFLATION OF SALINE BREAST IMPLANT WHICH WAS INITIALLY INSERTED 5/17/93.
CATHETER INSERTED PER CV ANESTHESIA. ON ARRIVAL TO CARDIAC SURGERY RECOVERY, PT'S CARDIAC OUTPUT WAS READING LOWER THAN PREVIOUSLY NOTED READINGS. SUSPECTED CATHETER MALFUNCTION. CATHETER WAS CHANGED AND CARDIAC OUTPUTS IMPROVED DRAMATICALLY.
CATHETER DISCONNECTED FROM PORT AND HAD BEGUN TO MIGRATE TOWARD HEART. PORT WAS REMOVED IN OR AND CATHETER WAS REMOVED IN RADIOLOGY. PORT IS AVAILABLE FOR INSPECTION BUT CATHETER WAS ERRONEOUSLY DISPOSED OF.
FAILURE OF DISPOSABLE AUTOMATIC CLIP APPLIER. DID NOT LOAD CLIP AND DEVICE CUT ARTERY. BLEEDING WAS IMMEDIATELY CONTROLLED AND ARTERY WAS LIGATED. (THIS SAME TYPE OF PROBLEM OCCURRED 10/11/94 IN RPTR'S FACILITY AND REPORT FILED THEN).
VALVE WASN'T FUNCTIONING DUE TO BREAKAGE BETWEEN THE CONNECTOR AND VENTRICULAR CATHETER. PT HAD TO HAVE SURGERY TO REPLACE MALFUNCTIONING VALVE.
BALLOON WOULD NOT INFLATE AT 8 ATM. STENT NOT DEPLOYED. CATHETER REMOVED WITH STENT. NO PT HARM.
STENT BALLOON WOULD NOT INFLATE AT 8 ATM UNDER FLUORO; APPEARED AT 10 ATM. ALSO HAD DIFFICULTIES WITH DEFLATION. STENT DEPLOYED SUCCESSFULLY. NO PT HARM.
RESPIRATORY THERAPY RECEIVED "STAT" CALL FROM NSG UNIT. UPON ARRIVAL - FOUND VENTILATOR ALARMING - SAFETY VALVE OPEN; "RUN EST DO NOT USE"; NURSES MANUALLY VENTILATING PT. VENTILATOR SWITCHED OUT.
RUPTURED LEFT BREAST IMPLANT SUSTAINED AFTER BEING KICKED IN THE LEFT BREAST WITH REMOVAL OF BOTH IMPLANTS. FINDINGS AT SURGERY: IN THE RIGHT BREAST CAPSULE WAS MODERATE IN EXTENT. IT WAS DENSELY ADHERENT TO THE CHEST WALL AND AS SUCH ABOUT 85% OF THE CAPSULE WAS REMOVED LEAVING A PATCH POSTERIORLY. THE IMPLANT ITSELF WAS INTACT BUT THERE WAS A FAINT FILM OF GEL BLEED ON THE SURFACE OF THE IMPLANT. ON THE LEFT SIDE THE CAPSULE WAS QUITE THIN. IT EXTENDED ALL THE WAY UP TO THE INFRACLAVICULAR AREA AND WAS TOO EXTENSIVE TO COMPLETELY REMOVE. THE PROXIMAL 50% OF THE CAPSULE WAS REMOVED AND IT WAS ALL LOCATED IN THE ANTERIOR PART OF THE CAPSULE. THE IMPLANT ITSELF WAS COMPLETELY RUPTURED WITH FREE SILICONE GEL WITHIN THE CAPSULE.
THE PT IS A 51-YR-OLD WOMAN WHO HAD BILATERAL AUGMENTATION IN 5/91 USING CO'S DOUBLE LUMEN TEXTURED SURFACE, 360CC IMPLANTS IN THE SUBMAMMARY SPACE. THE BREASTS BECAME QUITE HARD. THE PT HAS HAD CLOSED CAPSULOTOMY AS WELL AS MASSAGES WITHOUT EFFECT. SHE NOTICED THAT THE HARDNESS HAS PRESENTED DISCOMFORT IN SLEEPING AS WELL AS IN HUGGING FRIENDS. IN ADDITION, SHE HAS NOTED DEVELOPMENT OF SOME SYSTEMIC SYMPTOMS SUCH AS HAIR LOSS, AM STIFFNESS, MAMMARY DIFFICULTIES, AND A POSITIVE ANA TITER OF 1 TO 160. BECAUSE OF CONCERN OVER POTENTIAL FUTURE HEALTH PROBLEMS, A POSITIVE ANA, AS WELL AS SIGNIFICANT DISCOMFORT BECAUSE OF THE SEVERE CAPSULAR CONTRACTURE, IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS. TOTAL CAPSULECTOMY IS NECESSARY BECAUSE OF TEXTURED SURFACE IMPLANT AND BECAUSE OF CAPSULAR CONTRACTURE.
THE PT IS A 53-YR-OLD WOMAN WHO WAS AUGMENTED WITH CO BREAST IMPLANT, IN 10/84, USING AN INFRAMAMMARY INCISION PLACED IN THE SUBGLANDULAR PLANE. IN 9/95 SHE FELL. THEN SHE HAD A MAMMOGRAM. THERE WAS NO TRAUMA TO THE BREAST APPARENTLY, BUT THE MAMMOGRAM SHOWED LEFT SIDED RUPTURE AND HERNIATION OF THE IMPLANT ON THE RIGHT SIDE. THERE WAS A LOT OF PAIN FOLLOWING THE MAMMOGRAMS, FOR THESE REASONS SHE WAS EVALUATED. ON ULTRASOUND, SHE WAS NOTED TO HAVE A LEFT EXTRACAPSULAR RUPTURE WITH EXTRUSION FROM 12:00 AND EXTRUSION 7:30. AT THE NECK SUPPLE OF THE EXTRUSION, SILICONE GRANULOMA WAS DETECTED. ON THE RIGHT SIDE THERE WAS A PROBABLE EXTRACAPSULAR RUPTURE WITH HERNIATION AT THE 6:00 POSITION AND ALSO HAS SILICONE ADENOPATHY IN THE RIGHT FIRST, SECOND AND THIRD INTERSPACE IN THE INTERNAL MAMMARY CHAIN AS WELL AS IN THE RIGHT AXIL LARY LYMPH NODE. BOTH IMPLANTS ARE CONTRACTED. BECAUSE OF THE SIGNIFICANT RUPTURES AND SILICONE MIGRATION, IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS AND TO DO A TOTAL CAPSULECTOMY. THE PT IS OTHERWISE ASYMTOMATIC.
THE PT WAS A 50-YR-OLD FEMALE WHO HAD BILATEAL BREAST AUGMENTATION IN 1983, USING THE CO 205CC GEL FILLED BREAST IMPLANT. THE PT HAD A LOT OF PAIN IN THE RIGHT SHOULDER IN THE 1990'S AS WELL AS RIGHT LATERAL BREAST ACHES. THE PT HAD TO HAVE EXCISION OF CALCIFICATION IN THE RIGHT SHOULDER, IN ORDER TO MOBILIZE THE RIGHT SHOULDER. IN 1984 THE PT HAD A SIGNIFICANT PRESSURE APPLIED TO THE BREAST FOR A FILM SCREEN MAMMOGRAPHY. AT THAT TIME, THE PT ALSO HAD SEVERAL CLOSED CAPSULOTOMIES, BOTH SIDES FOR CAPSULAR CONTRACTURE. ON PHYSICAL EXAMINATION, THE PT HAD A CLASS III TO IV CONTRACTURE BOTH BREASTS. ULTRASOUND EXAMINATION SHOWED A RIGHT EXTRACAPSULAR RUPTURE WITH A SILICONE GRANULOMA CONTIGUOUS WITH THE CAPSULE AT THE 1:30 POSITION, AND THERE WAS ALSO A LEFT INTRACAPSULAR RUPTURE. BECAUSE OF RUPTURE, CONTRACTURE AND PAIN, REMOVAL OF THE IMPLANT WAS INDICATED. TOTAL CAPSULECTOMY WAS ALSO NECESSARY BECAUSE OF RUPTURE AND BECAUSE OF EXTRACAPSULAR RUPTURE ON THE RIGHT SIDE.
THE PT IS A 35-YR-OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 1986 USING CO BREAST IMPLANTS. SINCE THAT TIME, SHE HAS GOTTEN SEVERELY CONTRACTED WITH DEBILITATING PAIN IN THE RIGHT BREAST WHICH RADIATES TO THE RIGHT UPPER EXTREMITY. SHE HAS ALSO DEVELOPED SIGNIFICANT SYMPTOMS OF FATIGUE, DRY EYES, DRY MOUTH, MYALGIAS, ARTHRALGIAS. AS A RESULT OF THE ARTHRALGIA AND MYALGIA, SHE IS QUITE DEPENDENT ON PAIN MEDICATIONS. THE PT ALSO HAS ELEVATED ANTINUCLEAR ANTIBODIES AND ELEVATED SEDIMENTATION RATE IN THE PAST. ULTRASOUND AND XEROMAMMGRAM EXAMINATIONS DEMONSTRATE SUSPICIOUS RUPTURE ON THE RIGHT BUT INTACT IMPLANT ON THE LEFT.
THE PT IS A 42-YR-OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 12/82 USING THE CO DOUBLE LUMEN GEL FILLED BREAST IMPLANT, STYLE #76. THE DR ALSO PLACED 50CC OF SALINE AND 10 MILLIGRAMS OF STEROID IN THE OUTER LUMEN. WITHIN TWO YEARS, THE PT DEVELOPED A GREAT DEAL OF ALLERGIES. SHE HAD WELTS AND ITCHING. SHE ALSO HAD FLU-LIKE SYMPTOMS THAT ARE QUITE FREQUENTLY ASSOCIATED WITH CHRONIC FATIGUE. SHE HAS BEEN DIAGNOSED WITH FIBROMYALGIA. SHE HAS PAIN IN THE LATERAL INFERIOR BREAST AREA, ESPECIALLY GREATER ON THE RIGHT SIDE. BOTH IMPLANTS HOWEVER ARE INTACT. PHYSICAL EXAMINATION SHOWS CONTRACTURE ON THE RIGHT BUT NOT ON THE LEFT. BECAUSE OF SYSTEMIC SYMPTOMS, PAIN IN THE BREASTS, THE PT DESIRES IMPLANT REMOVAL. TOTAL CAPSULECTOMY IS MEDICALLY NECESSARY BECAUSE OF PAIN AND CONTRACTURE AS WELL AS BECAUSE THE CAPSULE CONTAIN SILICONE AND INFLAMMATORY REACTION WHICH THE PT MAY BE REACTING TO.
PT HAD PORT INSERTED 10/95 AT ANOTHER AREA HOSP. WAS ADMITTED TO THIS FACILITY FOR SURGICAL REMOVAL OF THE PORT BECAUSE IT HAD CRACKED DUE TO MUSCLE AND BONE RUBBING TOGETHER. FRACTURE OF CATHETER CONFIRMED BY VENOGRAM. UPON REMOVAL OF CATHETER, CATHETER WAS FOUND TO BE ADHERED TO LEFT SUBCLAVIAN VEIN AND VENA CAVA. TIP OF CATHETER COULD NOT BE FREED UP, AND REMAINS ADHERED. THUS, PT HAS RETAINED FOREIGN BODY (TIP OF CATHETER).
NURSE ATTEMPTED INSERTION OF IV LEFT WRIST AFTER UNSUCCESSFUL ATTEMPT IN LEFT FOREARM. WITH LEFT WRIST INSERTION, POSITIVE BLOOD RETURN, CATHETER ADVANCED AND IV FLUIDS CONNECTED BUT IV FLUIDS DID NOT DRIP. IV FLUIDS CLAMPED OFF. ATTEMPTED TO PULL OUT CATHETER. CATHETER PULLED OUT EASILY FOR ABOUT ONE INCH, THEN WOULD NOT COME OUT ANY FURTHER. ANOTHER NURSE WAS CALLED. THIS NURSE STABILIZED THE CATHETER AT SKIN AND ATTEMPTED TO REINSERT STYLET - MET RESISTANCE AND DISCONTINUED ATTEMPT. SHE THEN ATTEMPTED TO ADVANCE CATHETER. CATHETER  ADVANCED EASILY. SHE ALSO ROTATED CATHETER BUT STOPPED WHEN PT COMPLAINED OF PAIN WITH ROTATION. INFANT HEEL WARMER APPLIED TO SITE TO RULE OUT POSSIBLE VENOUS SPASM. A THIRD NURSE UNSUCCESSFULLY TRIED TO REMOVE CATHETER. DR ORDERED IV INSERTED IN RIGHT UPPER EXTREMITY. IV WAS STARTED IN RIGHT HAND WITH ONE ATTEMPT. ANESTHESIOLOGIST REMOVED CATHETER IN LEFT WRIST WITH APPROX 1/2" TO 3/4" OF CATHETER LODGED IN PT'S FOREARM. CONTINUOUS TRACTION APPLIED TO VEIN DURING AND AFTER THIS PROCEDURE. X-RAY OF LEFT FOREARM OBTAINED AND TOURNIQUET APPLIED FOR DURATION OF X-RAY WITH VEIN TRACTION RESUMED IMMEDIATELY AFTER X-RAY. PT TAKEN TO OPERATING ROOM FOR REMOVAL OF FOREIGN BODY LEFT UPPER EXTREMITY WITH CUTDOWN UNDER LOCAL ANESTHESIA. 18G CATHETER USED FOR ALL IV INSERTION ATTEMPTS IN LEFT AND RIGHT UPPER EXTREMITIES.
RPTR EXPERIENCED ITCHING, SWOLLEN EYES, WHEEZING AND SMALL BUMPS AND BLISTERS ON HAND AFTER USING LATEX GOVES. "MY ARM WAS SWOLLEN AND IT FELT LIKE FIRE."
BAG LEAKED PRIOR TO REMOVING FROM FOIL BAG. SEPARATION NOTED AT HEAT SEAL IN ADDITIVE PORTION OF DUAL BAG SYSTEM.
LUER ACTIVATED VALVE (LAV) ON EXTENSION SET DID NOT SEAL COMPLETELY ALLOWING BLOOD TO FLOW BACK FROM THE PT INTO THE EXTENSION SET, LAV AND IV ADMINISTRATION SET. THESE SETS WERE BEING TRIED BY THE HOSP BETWEEN 5/16/96 AND 6/27/96 AS A REPLACEMENT FOR ANOTHER PRODUCT. PRODUCT NO LONGER USED. MFR NOTIFIED AND PRODUCT RETURNED.
DURING PT TRANSPORT FROM THE OR TO THE ICU, WHILE THE PT WAS BEING MANUALLY VENTILATED USING A BAG, THE REAR ASSEMBLY THAT CONNECTS TO O2 RESERVOIR FELL OFF THE BAG. VENDOR WAS BROUGHT IN TO DISCUSS PROBLEM, WHERE OTHER BAGS OF SAME LOT ALSO FAILED.
ARMS IN OPERATING ROOMS HAVE PROBLEMS WITH DYNAMIC PRESSURE AND FLOWS.
SCLEROTHERAPY NEEDLE WAS PLACED. BREAK IN NEEDLE NOTED DURING FLUSHING. NEEDLE WAS IMMEDIATELY REPLACED WITH NO ADVERSE EFFECT ON PT OR COMPROMISE OF PROCEDURE.
THE LOCKING BOLT FOR INSERTION OF TIBIAL NAIL BROKE.
TIP OF INSTRUMENT BROKE OFF IN PT'S EYE DURING SURGERY. PORTION RECOVERED SUCCESSFULLY WITHOUT ANY DAMAGE TO PT'S EYE, USED IN REMOVAL OF OCULAR MEMBRANE. INSTRUMENT DESIGNED FOR IOL SURGERY.
DURING INTRAVASICULAR ADMINISTRATION OF LIVE BCG, INSTILLATION SPIKE AND TUBING, SUPPLIED BY MFR, MALFUNCTIONED. THIS RESULTED IN A POTENTIAL EXPOSURE OF LIVE BCG, TO THE RN ADMINISTERING THE MEDICATION. STAFF INSERVICING HAD BEEN PROVIDED BY THE MFR.
WHEN A PT PULLED HIS IV APART, A NURSE DONNED LATEX GLOVES AND HELD PRESSURE TO STOP THE BLEEDING. LATER, WHEN SHE REMOVED HER GLOVES, SHE NOTED A HOLE IN THE GLOVES. THE PT INVOLVED HAD HEPATITIS C. THIS INCIDENT CAUSED GREAT CONCERN ABOUT SAFETY AND THE POTENTIAL FOR SPREAD OF DISEASE FROM PT TO EMPLOYEE. SAMPLES OR LOT NUMBER WERE NOT NOTED AT THE TIME.
ON 5/1/96, RPTR HAD A POTENTIALLY SERIOUS SITUATION ARISE WITH AN INFANT BORN FOUR WEEKS EARLY IN UNSTABLE CONDITION. THE INFANT WAS PLACED ON CARDIOPULMONARY MONITORING WITH ELECTRODES. THIRTY MINS AFTER PLACING THE INFANT ON THE MONITOR, RPTR LOST THE RESPIRATORY WAVE FORM ON THE MONITOR, OVER THE NEXT 2 1/2 HRS RPTR COMPLETELY CHANGED MONITORS, MODULES, LEADS AND TRIED FOUR DIFFERENT PACKAGES OF THE ELECTRODES. RPTR CALLED THE MONITOR MFR'S 800 NUMBER TRYING TO FIND OUT WHY THEY COULDN'T MONITOR THIS INFANT'S RESPIRATORY RATE. THE INTENSIVE CARE UNIT STAFF MEMBERS WERE CALLED TO THE NURSERY AS WELL, BUT WERE UNABLE TO CORRECT THE PROBLEM. THE ENTIRE TIME THAT THEY WERE TROUBLESHOOTING THE PREMIE INFANT WAS HAVING EPISODES OF APNEA AND BRADYCARDIA. RPTR HAD A CORPSMAN SITTING BY THE BABY MONITORING RESPIRATORY RATE. THEY EVENTUALLY TRIED ADULT ELECTRODES FROM ICU AND THEY WORKED. AFTER EXAMINING THE ELECTRODES, RPTR DISCOVERED THAT THE CONDUCTION JELL WAS INSUFFICIENT TO ACCURATELY MONITOR INFANTS.
DURING A GENERAL ANESTHESIA WITH AN LMA, APPROX FOUR (4) MINS AFTER INDUCTION AND PLACEMENT OF LMA WITH PT SPONTANEOUSLY VENTILATING, THE PT BEGAN SPONTANEOUS MOVEMENT OF ARMS AND LEGS AND COUGHING. RPTR PUSHED 75MG OF PROPOFOL AND THE PT RETURNED TO SLEEP WITHOUT SPONTANEOUS VENTILATION. THE VAPORIZER DIAL WAS SET AT 6% WITH 2L/MIN OF NITROUS OXIDE AND 1L/MIN OF OXYGEN. HOWEVER, THE RI OF DESFLURANE INDICATED APPROX .8%. THE PT WAS MANUALLY VENTILATED AT A RATE OF 6-8/MIN. THE RI DESFLURANE ROSE TO 4.5% THAN BEGAN TO FALL TO LESS THAN 1.0%. THE VAPORIZER WAS TURNED OFF. THE PT WAS PUT ON PROPOFOL INFUSION WITH NITROUS OXIDE/OXYGEN 2:1 VIA SCCA. THE PT SUFFERED NO INJURIES AND DENIES ANY RECALL OF THE EVENT. SUSPECT UNIT WAS SENT BY HOSP TO MFR. THE ITEM IN QUESTION WAS REMOVED FROM SVC AND THE EQUIPMENT MFR'S SVC REP WAS CALLED. CO REP ARRIVED ON 6/12/96 AND RAN A COMPLETE FUNCTION TEST AND OUTPUT VERIFICATION ON THE EQUIPMENT BUT COULD NOT FIND ANY PROBLEMS. THE VAPORIZER HAS BEEN REMOVED FROM SVC PENDING FURTHER DISPOSITION.
THE CONDITION/SERVICEABILITY OF THIS TAPE IS SUBSTANDARD COMPARED WITH ANOTHER MFR'S. THE PLASTIC MATERIAL IS LOWER IN QUALITY, IT DOES NOT TEAR PROPELRY AND IT IS NOT AS ELASTIC AS THE OTHER BRAND. THE STICKY SIDE IS ALSO LOWER IN QUALITY. USER HAS TO CHANGE THE TAPE ON A PT AT LEAST TWICE A DAY. THE OTHER BRAND WILL LAST FOR 3 DAYS. IT IS ALSO DANGEROUS, THE TAPE GETS PEELED OFF UNNECESSARILY. RPTR HAS HAD 2 INCIDENTS WHERE AN INTRAVENOUS LINE WAS ALMOST PULLED OUT BECAUSE THE TAPE BECAME UNDONE, IF IT HAD NOT BEEN OBSERVED THAT THE TAPE WAS GETTING LOOSE, RPTR WOULD HAVE LOST THOSE IV SITES AND THAT WOULD ADD SUFFERING TO THE PT. THE PERFORMANCE OF THE TAPE ON A DIAPHORETIC PT IS WORSE.
RECEIVED ELECTRIC SHOCK THERAPY FROM A PSYCHIATRIST. TRIED TO COMMIT SUICIDE AFTERWARDS, LOST HER HUSBAND AND HER HOME. NOW HAS PERMANENT, IRREVOCABLE MEMORY LOSS OF EVENTS IN THE PAST, AND DIFFICULTY WITH SHORT TERM MEMORY. SHE HAS DEVELOPED SINCE THAT TIME A SEIZURE DISORDER WHICH HAS BEEN ATTRIBUTED TO SHOCK THERAPY. SHE COMPLAINS THAT SHE IS NOW AGORAPHOBIC, AND STILL SEVERELY DEPRESSED. SHE HAS LOST HER COLLEGE EDUCATION. SHE HAS LOST COORDINATION. SHE HAS BEEN UNABLE TO WORK SINCE THAT TIME, AND IS ON DISABILITY. EVENT DATE 1979 TO 6/1981.
DURING ORTHOPEDIC/SURGICAL REPAIR OF FRACTURED TIBIA, THE TIP OF THE ELEVATOR BROKE OFF IN WOUND. IT WAS THEN LOCATED UNDER FLUOROSCOPY AND THE TIP WAS RETRIEVED BY THE PHYSICIAN.
A SINGLE 0.564 INCH DRILL BIT FRACTURED WITHIN THE LEFT PATELLA. DUE TO RISK OF PATELLA FRACTURE OR DAMAGING THE PATELLA TENDON REPAIR, IT WAS LEFT IMPLANTED IN THE PATELLA. SCREW APPEARED WELL FIXED.
TWENTY-TWO MIN RAPID INFUSION OF IV SEDATION INTENDED FOR 24 HR VOLUME, OCCURRED DURING IMMEDIATE POST-OP PERIOD. PT TO BE VENTILATED FOR SEVERAL DAYS, SO NO ADD'L SUPPORT REQUIRED AS A RESULT OF THIS EVENT. RECEIVED FLUMAZENIL DRIP (@ 0.2MG). 6/12/96 INFUSION PUMP PERFORMANCE VERIFICATION IN BIOMED. (NO PROBLEM FOUND). RETURNED TO MFR FOR EVALUATION 6/24/96.
VAPORIZER OUTPUT WAS SET FOR 1% HALOTHANE, BUT DELIVERED 5%. ANALYZER IN-LINE ALTERED TO HIGH LEVEL. ESTIMATED HIGH FLOW TIME PERIOD WAS 1-2 MINS. HALOTHANE DISCONTINUED IMMEDIATELY.
FOLEY CATHETER (BULB) WOULD NOT DEFLATE. CATHETER WAS CUT X 2, STILL APPEARED INFLATED, RESISTENCE TO WITHDRAWAL NOTED. UROLOGIST WAS CALLED. GUIDE WIRE WAS USED TO CLEAR LUMEN AND FOLEY CATHETER WAS REMOVED WITHOUT TRAUMA.
POSSIBLE CONTAMINATION BECAUSE THE GLOVE IS DETERIORATING AND THERE IS NO PROTECTIVE BARRIER. THE GLOVES ARE FULL OF HOLES AND TEAR EASILY.
BAXTER HEALTHCARE CORP. RT 120 & WILSON RD, ROUND LAKE, IL 60073-0490. ONE USED Y-TYPE EXTENSION, PRODUCT CODE 2N3371, SET WAS RECEIVED AT OUR FACILITY FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE SHOWED THAT THE TUBING HAD SEPARATED FROM THE MALE LUER LOCK ADAPTER DUE TO AN INSUFFICIENT SOLVENT BOND. THE LOT NUMBER OF THE SAMPLE INVOLVED COULD NOT BE DETERMINED.
ONE MONTH AGO A PHYSICIAN WAS PLACING THE CATHETER. HIS PT DEVELOPED HYPERTENSION, SHORTNESS OF BREATH, DIAPHORESIS, CHEST PAIN, HIVES, AND TONGUE SWELLING. PHYSICIAN WAS READING AN ARTICLE ON 7/1/96 WHICH WAS PUBLISHED IN THE FDA MEDICAL BULLETIN AND REALIZED THAT HIS PT HAD THE SAME SYMPTOMS THAT WERE ADDRESSED IN THE ARTICLE.
PT WAS IMPLANTED WITH A NEUROSTIMULATOR IN JAN. THE LEFT LEAD SHOCKED PT IN THE CHEST. DR TURNED THE LEFT LEAD OFF ALTOGETHER. THE RIGHT LEAD STARTED SHOCKING PT 2 MONTHS LATER. THE REP SAID RPTR'S BACK WAS TOO BAD FOR THE DEVICE. RPTR'S DR THEN REFERRED HER TO ANOTHER DR. THE REP FROM THE CO WOULD NO LONGER TALK TO PT. RPTR NOW HAS A PERMANENT LUMP IN HER BACK WERE THE WIRES ARE.
PT FOUND UNRESPONSIVE/CYANOTIC WITH INNER CANNULA OF TRACH PULLED OUT ON CHEST. VENTILATOR DID NOT ALARM WHILE ATTACHED TO INNER CANNULA LYING OUTSIDE OF PT. ALARM FAILED TO ALERT STAFF THAT EQUIPMENT NOT INTACT.
LAB TESTING OF THE DEVICE COULD NOT BE PERFORMED SINCE THE REPORTING HOSP REQUESTED ANONYMITY AND; THEREFORE, THE INSTITUTION COULD NOT BE CONTACTED TO REQUEST THAT THE DEVICE BE RETURNED FOR EVALUATION. ADDITIONALLY, THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED BY THE REPORTING INSTITUTION; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE PERFORMED. DUE TO THE REQUEST OF THE RPTR TO REMAIN ANONYMOUS, FURTHER INFO COULD NOT BE OBTAINED. THE EXPECTED FREQUENCY FOR STENT EMBOLIZATION IS 1.14%. THE REPORTED INCIDENT RATE IS 0.08%. EXPECTED INCIDENT RATES ARE BASED ON DATA OBTAINED FROM THE CLINICAL TRIALS UPON WHICH APPROVAL FOR DOMESTIC USE OF THIS DEVICE IS BASED. THESE DATA AREA INCLUDED IN THE DIRECTIONS FOR USE. REPORTED INCIDENT RATES WERE BASED ON A COMPILATION OF ALL STENT EMBOLIZATIONS REPORTED IN CONJUNCTION WITH ALL PRODUCT INQUIRIES REPORTED TO CORDIS, A JOHNSON & JOHNSON CO FROM 1/94 THROUGH 6/96. THE OBSERVED INCIDENT RATES NOTED ABOVE WERE CALCULATED BY DIVIDING THE NUMBER OF OBSERVED EVENTS DIVIDED BY THE NUMBER OF DEVICES SHIPPED FROM 1/94 THROUGH 6/96. REVIEW OF MANDATORY AND VOLUNTARY REPORTS INDICATES NUMEROUS COMPLAINTS OF STENT MIGRATION OFF THE DELIVERY SYSTEM. TO WHAT DOES THE FIRM ATTRIBUTE THIS PROBLEM? WHAT ACTION HAS BEEN INITIATED TO RESOLVE PROBLEMS OF THIS NATURE? ALTHOUGH THE ROOT CAUSE OF THE EMBOLIZATION OF THE STENT COULD NOT BE IDENTIFIED, PRODUCT LABELING (APPENDIX III) SPECIFICALLY STATES NOT TO PRE-INFLATE THE BALLOON CATHETER OR APPLY NEGATIVE PRESSURE TO THE CATHETER PRIOR TO PLACEMENT OF THE STENT ACROSS THE LESION AND RETRACTION OF THE SHEATH, AS THIS COULD CAUSE PREMATURE DISLODGEMENT OF THE STENT FROM THE BALLOON. LABELING ALSO STATES THAT THE POSITIONING OF THE SHEATH OVER THE STENT SHOULD BE VERIFIED PRIOR TO INSERTION ON THE GUIDEWIRE. AFTER ADVANCEMENT OF THE STENT DELIVERY SYSTEM, THE LOCK-OUT DEVICE SHOULD BE REMOVED FROM THE BACK-END OF THE STENT DELIVERY SYSTEM BEFORE THE TUOHY-BORST VALVE IS LOOSENED. PRODUCT LABELING ALSO STATES THAT IF RESISTANCE IS ENCOUNTERED WHILE ADVANCING THE SHEATH OR THE STENT/BALLOON ASSEMBLY TO THE SITE OF THE PREVIOUSLY DILATED LESION, THE ASSEMBLY MAY BE WITHDRAWN THROUGH THE INTRODUCER SHEATH AND GUIDE CATHETER AND THE PROCEDURE ABORTED. IN ADDITION, AN EFFORT TO ESTABLISH CLINICALLY RELEVANT STENT RETENTION VALUES HAS BEEN INITIATED AND IS EXPECTED TO BE COMPLETE BY THE END OF 8/96. PORTIONS OF THE DEVICE MFG PROCESS WILL BE IMPROVED AND REVALIDATED AS NECESSARY TO ACHIEVE THIS SPEC. WE BELIEVE IMPROVED STENT RETENTION WILL REDUCE PRODUCT COMPLAINTS IF THIS TYPE.
PHYSICIAN HAD DIFFICULTY INSERTING SUPRAPUBIC CATHETER. UPON EXAMINING THE TIP OF THE CATHETER IT WAS NOTED THAT THERE WAS A CHIPPED OFF PORTION OF PLASTIC TIP.
DURING CARDIAC CATH THE PHYSICIAN COULD NOT GET THE STENT TO OPEN THE RIGHT CORONARY ARTERY. THE WHOLE STENT CAME OFF THE BALLOON. THE GUIDE CATHETER MAY HAVE BEEN TOO SMALL OR DEFECTIVE. 6/19 A RIGHT ANGIOGRAM AND CAB WAS COMPLETED, THE AREA WAS BYPASSED AND THE STENT WAS LEFT IN PT'S RIGHT CORONARY ARTERY.
ADEQUATE AMOUNT OF BLOOD PLACED IN MACHINE. BLOOD SUGAR READ AT 29. NURSE ASKED PT IF HE FELT LIKE HIS BLOOD SUGAR WAS 29. PT STATED "NO." ANOTHER ADEQUATE DROP OF BLOOD PLACED IN NEW STRIP. BLOOD SUGAR READ 140. MACHINE WAS QUALITY CONTROL CHECKED 6/19/96, 0800.
THE HANDLES ON THE FOOT BOARDS OF THE BEDS ARE BREAKING OFF. THE HARD PLASTIC HANDLES HAVE EITHER COMPLETELY BROKEN OR HAVE CRACKED AND ARE NEAR BREAKING. THE EDGES ARE SHARP AND ALSO LEAVE THE FOOTBOARD OPEN FOR SPILLS.
JAN 1983 BILATERAL AUGMENTATION WITH GEL MAMMARY IMPLANTS, PLACED IN SUBGLANDULAR POSITION. SINCE THEN HAS DEVELOPED A SIGNIFICANT CAPSULE ON LEFT WITH PAIN AND MODERATE CAPSULE ON RIGHT. NO SYSTEMIC MAGNIFICATION. 6/20/96 PT UNDERWENT BILATERAL CAPSULECTOMIES AND SUBPECTORAL CONVERSION USING SALINE IMPLANTS. AT THE TIME OF SURGERY 6/20/96 LEFT BREAST IMPLANT WAS INTACT BUT RIGHT IMPLANT WAS RUPTURED.
INFECTION LED TO MALFUNCTIONING URINARY SPHINCTER; IMPLANT REMOVED.
LEFT IMPLANT RUPTURED. RIGHT IMPLANT INTACT. LEFT IMPLANT IMPLANTED IN 1/17/84.
PT RETURNED TO PHYSICIAN'S OFFICE. IMPLANTED DEVICE DEFLATED.
PT WAS POST CARDIAC ARREST AND ON RESPIRATOR. ROUTINE MORNING BLOOD GAS DRAWN - REVEALED PO 43. MONITOR SHOWING SAO2 94%. BLOOD GAS REPEATED STAT - SHOWED PO 42.5. ANOTHER PULSE OX PLACED ON PT AND SHOWED SAO2 83%.
CHEST X-RAY DONE AFTER PLACEMENT OF CENTRAL LINE. TUNGSTEN CAPSULE NOTED IN REGION OF FUNDUS OF STOMACH. CAPSULE IS FRACTURED WITH BEADS IN STOMACH AND DUODENUM.
BILATERAL RUPTURED BREAST IMPLANTS 200CC.
THE PT WAS A 40-YR-OLD FEMALE WHO WAS AN INSULIN DEPENDENT DIABETIC. SHE HAD BILATERAL BREAST AUGMENTATION IN 1989. HER DIABETES HAS BEEN PRESENT SINCE THE AGE OF 20. THE PT HAD A NUMBER OF SYMPTOMS WHICH MAY EITHER BE DUE TO HER DIABETES MELLITUS OR TO HER IMPLANT AND HAD SIGNIFICANT PSYCHOLOGICAL DISTRESS FROM HAVING THESE IMPLANTS. TOTAL CAPSULECTOMY WAS MEDICALLY NECESSARY BECAUSE THE CAPSULE CONTAINED SILICONE WHICH THE PT MAY BE REACTING TO.
THE PT IS A 53-YR-OLD ORIENTAL WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 1974 WITH 75CC USING CO'S IMPLANTS. SHE DEVELOPED CAPSULAR CONTRACTURE ON THE RIGHT SIDE WITHIN SIX YEARS. THEN IN THE PAST FIVE TO SIX YEARS, SHE DEVELOPED MYALGIAS IN THE SHOULDERS AND ELBOW, RIGHT SIDE GREATER THAN THE LEFT SIDE. IN ADDITION, SHE DEVELOPED FATIGUE, SHARP PAINS IN THE CHEST, DRY EYES, DECREASED SHORT TERM MEMORY CAPACITY. ON ULTRASOUND XEROMAMMOGRAM EXAMINATION OF THE BREAST, SHE HAS A DEFINITIVE LEFT INTRACAPSULAR RUPTURE BUT RIGHT SIDE IMPLANT INTACT. THERE IS CALCIFICATION OF THE CAPSULE ON THE RIGHT SIDE. THERE IS ALSO SEVERE CAPSULAR CONTRACTURE ON THE RIGHT SIDE AND A MODERATE CONTRACTURE ON THE LEFT SIDE GRADE 3. TOTAL CAPSULECTOMY IS MEDICALLY NECESSARY BECAUSE OF THE CALCIFICATION OF THE CAPSULE ON THE RIGHT AND RUPTURE ON THE LEFT AND LOCAL PAIN AS WELL AS SYSTEMIC SYMPTOMS.
THE PT IS A 39-YR-OLD WOMAN WHO HAD BILATERAL BREAST AUGMENTATION IN 1986 USING CO'S GEL FILLED BREAST IMPLANTS. THE PT NOTED IMMEDIATE CAPSULAR CONTRACTURE. THEY DEVELOPED IN THE LAST THREE TO FOUR YEARS, ARTHRALGIA, MYALGIAS, FATIGUE, DRY EYES AND WAS DIAGNOSED WITH FIBROMYALGIA. THE PT ALSO HAD SUBJECTIVE FEELINGS OF SHORTNESS OF BREATH AND CONSTRICTIVE FEELING IN THE CHEST. ON PHYSICAL EXAMINATION, SHE HAS CLASS IV CONTRACTURES IN BOTH BREASTS AND TENDER AXILLA, LEFT SIDE GREATER THAN THE RIGHT SIDE. XEROMAMMOGRAM AND ULTRASOUND EXAMINATION DEMONSTRATES A LEFT EXTRACAPSULAR CONTRACTURE AND PAIN, AS WELL AS SYSTEMIC SYMPTOMS THAT MAY BE RELATED TO HER BREAST IMPLANTS IT IS MEDICALLY NECESSARY TO REMOVE BOTH IMPLANTS.
RIGHT IMPLANT FAILURE. NO RECORD OF ORIGINAL SURGERY.
PTCA/DCA/STENT OF RCA USING A .014 CO'S EXTRA SUPPORT 300 CM WIRE. UPON REMOVAL OF THE WIRE THE DISTAL TIP SEPARATED FROM WIRE AND REMAINS IN DISTAL VESSEL.
EXPLANT OF RIGHT AND LEFT BREAST IMPLANTS. RIGHT IMPLANT RUPTURED.
PT ADMITTED FOR REMOVAL OF RUPTURED BREAST IMPLANTS (SALINE).
EXPLANT OF TWO SILICONE FILLED BREAST IMPLANTS.
UNDERWENT BILATERAL EXPLANTATION OF BREAST IMPLANT AND CAPSULECTOMIES. UPON EXPLANTATION EACH IMPLANT WAS EXCAPSULATED WITH FIBROUS TISSUE, EACH IMPLANT WAS YELLOWED AND HAD A GEL LEAK.
STENT BALLOON WOULD NOT INFLATE AT 7 ATMS. CATHETER REMOVED WITH STENT INTACT. NO PT HARM.
PT WAS HELPED TO BED BY 2 CNAS, BOTH REPORT RAISING THE SIDE RAIL. APPROX 1 1/2 HRS LATER, PT WAS HEARD CALLING, AND WAS FOUND ON THE FLOOR BY HER BED - SIDE RAIL WAS DOWN.
ON 5/26/96 AT APPROX 17:45 HRS PT WAS FOUND DISCONNECTED FROM VENTILATOR WITH NO AUDIBLE ALARMS. NURSING PERSONNEL INDICATED THE VISUAL ALARM OR SCREEN WAS "FLASHING."
FILTER DISLODGED AND TRAVELED TO PT'S HEART. INTERVENTIONAL RADIOLOGY RETRIEVED. PT LATER DEVELOPED CARDIAC TAMPONADE, WENT TO SURGERY FOR CARDIAC WINDOW AND REPAIR OF LACERATION TO ATRIA.
STENT BALLOON WOULD NOT INFLATE AT 7 ATMS. CATHETER REMOVED WITHOUT STENT. STENT RETRIEVAL. THREE ATTEMPTS WERE MADE BUT WERE UNSUCCESSFUL. STENT REMAINS IN PT IN DESCENDING AO/ILIAC REGION. NOT SENT FOR SURGERY. PT STABLE UPON EXITING CATH LAB.
UNDERWENT EXPLANTATION OF RUPTURED LEFT BREAST IMPLANT, AND INTACT RIGHT BREAST IMPLANT.
PT HAD CATARACT EXTRTACTION WITH INTRAOCULAR LENS INSERTED - DATE UNKNOWN. NOW PRESENTS WITH CORNEAL DECOMPENSATION. INTRAOCULAR LENS REMOVED AND NEW LENS INSERTED.
PT HAD PENILE PROSTHESIS IMPLANTED. PROSTHESIS HAS FAILED AND HAS BEEN REPLACED.
CATHETER FLOATED VIA LEFT SUBCLAVIAN VEIN. UNABLE TO PASS, WHEN WITHDRAWN, CATHETER HAD NO BALLOON ON IT. CATHETER TAKEN OUT, BALLOON NOT IN LUMEN. PT ASYMTOMATIC. NO CHANGE IN PLAN OF CARE.
PT'S MAMOGRAM INDICATED PROBABLE RUPTURES OF GEL IMPLANTS (DOUBLE LUMEN). SURGERY REVEALED RUPTURED ON THE LEFT IMPLANT (BOTH LUMENS) AND RUPTURED ON THE OUTER LUMEN OF THE RIGHT IMPLANT.
LAPAROSCOPIC RING APPLICATOR MALFUNCTIONED DURING PROCEDURE AND CLIP LOCKED. HAD TO UTILIZE MORE DESTRUCTIVE METHOD CALLED BIPOLAR LOAQULATER TO COMPLETE PROCEDURE.
DURING A DIAGNOSTIC PROCEDURE USING THE DEVICE, A DISSECTION OCCURRED AT THE RIGHT OSTIUM WHICH SPIRALED DOWN THE RIGHT CORONARY ARTERY. THE PHYSICIAN PERFORMED AN EMERGENCY ANGIOPLASTY, DEPLOYING THREE STENTS, TO REPAIR THE ARTERY DISSECTION. THE PT HAD AN UNEVENTFUL RECOVERY. THE DEVICE WAS DISCARDED BY THE CATH LAB.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PATELLA WAS LOOSE, TIBIAL BASEPLATE WAS LOOSE WITH GAPS AND TIBIAL INSERT WAS WORN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT EXPERIENCED PAIN AND SWELLING. KNEE WAS REVISED USING A NEW INSERT AND PATELLA.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
FOLLOWING IMPLANTATION, THE TIBIAL INSERT WAS OPENED FOR IMPLANTATION. THE INSERT WOULD SEAT FLUSH WITH THE PROXIMAL SURFACE OF TIBIAL BASEPLATE. UTILIZING THE PERIOSTEAL ELEVATOR THE INSERT WAS OPENED AND IMPLANTED WITHOUT INCIDENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT EXPERIENCED PAIN AND WAS SEEN BY DR. ON X-RAY HE NOTED THAT THE PLASTIC PART OF THE PATELLA COMPONENT HAD DISASSOCIATED FROM THE METAL BACKING. DURING SURGERY IT WAS NOTED THAT THE PATELLA HAD WORN AND THE POLYETHYLENE INSERT HAD DELAMINATED, WORE ON MEDIAL SIDE. AFTER COMPRESSION, THE PATELLA IMPLANT DISASSOCIATED FROM CEMENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TIBIAL BASEPLATE HAD SUBSIDED, TIBIAL INSERT WAS WORN, PATELLA WAS WEARING ON TOP. THE PT HAD THE TOTAL KNEE FOR 10 YEARS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AT 11:30 PM, NA/R CAME TO GET NURSE, STATING RESIDENT WAS ON THE FLOOR. FOUND RESIDENT WITH HEAD BETWEEN 1/2 SIDERAIL AND MATTRESS - FACE DOWN, FEET ON THE FLOOR. RESIDENT ASSISTED TO BED - OXYGEN WAS OFF AT THIS TIME - NASAL CANNULA PLACED IN NOSE BY NURSE. RESIDENT DID NOT BREATHE FOR FIRST 3 MINS OF ASSESSMENT. NO RESPONSE TO STIMULI. DR NOTIFIED 11:45 PM STATED MONITOR NEUROS, CALL WITH ANY CHANGES. DR PHONED THREE TIMES ON 4/20/96 DUE TO RESPIRATORY PROBLEMS. DR VISITED 4/22/96 PROGRESS NOTES INDICATED VERY DIFFICULT PROBLEM OF COPD/RESPIRATOR FAILUIRE, RIGHT HEAR FAILURE, SEVERE AORTIC STENOSIS AND ASSOCIATED LEFT HEART FAILURE. DR RE-CHECKED 4/24/96 PROGRESS NOTES INDICATE COMPLAINTS OF ABDOMINAL PAIN, MAIN FINDING ANEMIA, APPEARS BETTER TODAY.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  CRITICAL CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  PATIENT'S CONDITION - PREDISPOSED EVENT.  CONCLUSION:  THERE WAS NO DEVICE FAILURE.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  INSERVICED BY OTHER FACILITY STAFF.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS MALE PT UNDERWENT A LEFT TOTAL HIP REPLACEMENT (CEMENTLESS) ON 2/7/92 FOR OSTEOARTHRITIS OF THE LEFT HIP. ON 3/18/96 THE PT PRESENTED TO THE EMERGENCY CARE CTR COMPLAINING OF ACUTE LEFT HIP PAIN AND INABILITY TO WALK BECAUSE OF THE PAIN. X-RAYS REVEALED A DISLOCATION OF THE LEFT TOTAL HIP REPLACEMENT WITH FRACTURE OF THE FEMORAL HEAD PORTION OF THE FEMORAL COMPONENT. ON 3/19/96, THE PT UNDERWENT REVISION LEFT HIP ARTHROPLASTY; SYNOVECTOMY, LEFT HIP; FEMORAL SHAFT OSTEOTOMY WITH OPEN REDUCTION AND INTERNAL FIXATION USING CABLE GRAFTS AND PROXIMAL FEMORAL ALLOGRAFTING.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  OTHER.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
WHILE PT WAS WALKING ON TREADMILL, TREADMILL SPEEDED UP THROWING PT OFF OF TREADMILL FRACTURING RIGHT ARM. PT WAS THEN ADMITTED INTO HOSP.
WHEN PT WAS APPROACHED FOR REGULAR MONITORING, A CLEAR BOLUS OF AIR, APPROX 2 INCHES LONG, WAS NOTED MOVING RAPIDLY DOWN THE VENOUS BLOOD LINE BELOW THE LINE CLAMP ON A CO MACHINE. THE LINE WAS CLAMPED IMMEDIATELY AND THE PT DID NOT RECEIVE THE BOLUS OF AIR. TWO STAFF MEMBERS CONFIRMED THE PRESENCE OF AIR BELOW THE CLAMP POSITION. THE DRIP CHAMBER WAS APPROX 2/3 FULL OF BLOOD AND NO CLOT WAS SEEN, ALTHOUGH THE CHAMBER WAS PLACED ABOUT 1/2 - 3/4 INCHES ABOVE THE RECOMMENDED HEIGHT IN THE DRIP CHAMBER. THE VENOUS LINE WAS IN THE LINE CLAMP AND THE COVER WAS CLOSED. THE MACHINE DID NOT ALARM, EITHER VISUALLY OR AUDIBLY, NOR DID THE LINE CLAMP CLOSE. THE MACHINE WAS PUT THROUGH THE TEST MODE PRIOR TO BEGINNING DIALYSIS AND IT PASSED. THE PT SUFFERED NO APPARENT ADVERSE EFFECTS OTHER THAN SLIGHT CHEST TIGHTNESS WHICH OCCURRED WHEN SHE WAS MOVED TO ANOTHER MACHINE AND SHE BECAME SOMEWHAT FRIGHTENED IN SPITE OF HAVING BEEN PREPARED FOR THE MOVE. SHE WAS PLACED ON LEFT SIDE IN TRENDELENBURG POSITION FOR 30 MINS JUST IN CASE SOME PREVIOUSLY UNDETECTED AIR MAY HAVE PASSED THROUGH. THE NEXT DAY DURING A REGULAR OFFICE VISIT, SHE TOLD THE NEPHROLOGIST THAT SHE HAD SUFFERED CHEST TIGHTNESS AND SHORTNESS OF BREATH FOR SEVERAL YEARS, BUT HAD NEVER REPORTED IT. SHE STATED THAT THESE SYMPTOMS WERE EXACERBATED BY BEING TIRED OR OVER STRESSED. IT SEEMS LIKELY THAT THE TIGHTNESS DURING THE ABOVE INCIDENT MAY HAVE BEEN PROVOKED BY THE STRESS OF THE SITUATION.
WHEN ATTEMPTING TO REMOVE LEFT FEMORAL VENOUS SHEATH SHAFT FRACTURED. HUB PRESENT - VENOUS CATHETER REQUIRED SURGICAL REMOVAL.
LEFT BREAST IMPLANT INSERTED AT PHYSICIAN OFFICE APPROX SIX YEARS AGO BECAME DEFLATED. PT SCHEDULED HERE FOR REMOVAL AND REPLACEMENT LEFT BREAST IMPLANT. DEFLATED IMPLANT GIVEN TO PHYSICIAN FOR RETURN TO MFR.
PT ON VENTILATORY SUPPORT THROUGH ET TUBE. VENT FAILED TO COMPLETE CYCLE. NO ALARMS SOUNDED. PT EXPERIENCED CARDIOPULMONARY ARREST. SUCCESSFULLY RESUSCITATED.
FOLEY CATHETER BROKE OFF AT HUB X 2. BOTH REMOVED WITHOUT INCIDENT.
RETAINED LAP SPONGE. REQUIRED REEXPLORATION OF ABDOMEN. DISCOVERED ON POST-PROCEDURE X-RAY.
PT HAS LONG HISTORY OF CAPSULAR CONTRACTURE WITH HER IMPLANTS. THE ORIGINAL SURGERY WAS 3/21/86. SHE HAD 275CC HIGH PROFILE IMPLANTED. SUBSEQUENTLY SHE HAS HAD FOUR SURGERIES TO CORRECT CAPSULAR CONTRACTURE ON EACH BREAST AND BILATERALLY. SHE PRESENTED AGAIN 8/95 WITH CAPSULAR CONTRACTURE. 4/10/96 SHE HAD BILATERAL ANTERIOR CAPSULOTOMY WITH MEDIAL CAPSULORRHAPHY AND REPLACEMENT OF THE GEL IMPLANTS WITH SALINE FILLED IMPLANTS.
CHEST ELECTROSURGICAL UNIT HAD RETURN ELECTRODE ON LEG. BURN TO RIGHT MEDIAL PROXIMAL LEG. AREA EXCISED AND CLOSED BY SURGEON.
THE PT IS A 41-YR-OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 1987. FOLLOWING IMPLANTATION, SHE DEVELOPED CAPSULAR CONTRACTURE IMMEDIATELY. IN 1991, SHE DEVELOPED HEADACHES, VERTIGO, RINGING IN THE EARS AND MUSCLE ACHES IN THE NECK AS WELL AS JOINT PAINS IN THE HAND AND FEET, AND FATIGUE. IN ADDITION, THE PT ALSO HAS SJOGREN'S SYNDROME. MOST RECENTLY, SHE HAS NOTED INCREASING BREAST TENDERNESS WHERE THE IMPLANT ON THE LEFT SIDE IS MORE PAINFUL. TOTAL CAPSULECTOMY IS NECESSARY BECAUSE OF THE CONTRACTURE AND BECAUSE OF SUSPECTED RUPTURE IN THE LEFT SIDE.
PUMP WAS IMPLANTED INTO PT W/MS. ISOTOPE STUDY SHOWED PUMP NOT FUNCTIONING. IN OR PUMP FOUND TO BE DEFECTIVE. REPLACED WITH NEW PUMP. PUMP DELIVERING 250 MCG BACLOFEN/DAY AT DISCHARGE. SYMPTOMATICALLY IMPROVED AT TIME OF DISCHARGE. PROBLEM WAS NOT REPORTED FROM OR. DISCOVERED WITH PT COMPLAINT RE: BILLING FOR THE REPEAT PROCEDURE.
NURSE TECH FOUND PT ON CPM MACHINE IN FLEX POSITION WHEN HE ANSWERED THE PT'S CALL LIGHT. PT C/O PAIN. MACHINE WOULD NOT WORK. PT WAS REMOVED FROM CPM MACHINE. EVENT WAS REPORTED TO ATTENDING PHYSICIAN AND THERAPIST.
PT HAD BILATERAL BREAST AUGMENTATION WITH SALINE FILLED BREAST IMPLANTS SIZE 270CC IN 1992 BY ANOTHER PHYSICIAN. THE RIGHT IMPLANT RUPTURED, THE LEFT BREAST HAD CAPSULAR CONTRACTURE.
PT UNDERWENT A LEFT TOTAL HIP PROCEDURE ON 5/10/96. ON THE MORNING OF 5/11/96, THE PT WAS NOTED TO HAVE LEFT FOOT DROP. THE PHYSICIAN INDICATED THE PT PROBABLY HAS LEFT PERONEAL NERVE PALSY SECONDARY TO A TIGHT STRAP FROM THE ABDUCTION PILLOW AROUND THE PT'S LEFT CALF. HE ALSO STATED THAT THE PT IS SUSCEPTIBLE DUE TO PRE-OP BACK PROBLEMS.
PT WAS SCHEDULED FOR REMOVAL OF BREAST IMPLANTS. THE RIGHT SILICONE IMPLANT WAS RUPTURED BEFORE IT WAS REMOVED, THE LEFT SILICONE IMPLANT WAS INTACT. THERE IS NO WAY TO DETERMINE THE CO THAT MADE THE MAMMARY IMPLANTS, IMPLANATION DONE 10 YEARS AGO AT ANOTHER HOSP.
CATHETER INSERTED AND FUNCTIONING PROPERLY. APPROX 8 HRS, AT WHICH TIME THERMOMETER FAILED TO READ BLOOD TEMP PREVENTING OBTAINING CARDIAC OUTPUT READINGS. ALL EQUIPMENT WAS CHANGED TO VERIFY CATHETER FAILURE.
CATHETER INSERTED AND FUNCTIONED PROPERLY FOR APPROX 6 HRS. INITIAL CARDIAC OUTPUTS READ CORRECTLY WITH GOOD WAVE FORM. SIX HRS LATER, THERMOMETER WOULD NOT REGISTER BLOOD TEMP. ALL EQUIPMENT/WIRES WERE CHANGED TO VERIFY CATHETER FAULT. CONFIRMED THE NEXT MORNING BY BIOMEDICAL ENGINEERING.
WIFE OF PT NOTICED COVER ON PUMP SET WAS SHORTER THAN OTHERS PT HAD BEEN USING. TUBING REMOVED FROM PT'S HOME. INSPECTION OF OTHER TUBING OF THAT STOCK # IN INVENTORY REVEALED NO SIMILAR PROBLEMS.
DURING ESOPHAGEAL BANDING PROCEDURE, BANDING ADAPTER WOULD NOT REMOVE EASILY FROM OVERTUBE AND SEEMED TO CATCH ON OVERTUBE AFTER BAND WAS RELEASED ONTO VARIX. AFTER THE SECOND PASSAGE, THE ESOPHAGEAL MUCOSA WAS PULLED UP IN BETWEEN THE ADAPTER AND THE OVERTUBE CAUSING IT TO BLEED AND A SMALL HEMATOMA. EVEN THOUGH THIS PT DOES NOT HAVE SERIOUS OR PERMANENT DAMAGE, THIS HAS HAPPENED 5-6 TIMES BEFORE WITH THIS PIECE OF EQUIPMENT.
DURING ERCP, TOME BEING USED TO DO SPHINCTEROTOMY. MD STATES "WIRE IS BROKEN ON SPHINCTEROTOMY." PULLED SPHINCTERTOME OUT - NOTICED FULL CUTTING WIRE GONE. UNABLE TO RETRIEVE. LEFT IN PT TO PASS NATURALLY. UNABLE TO VIEW ON FLUORO.
EARLY AM PRIOR TO EVENT, IAPB ALARMED "AIR LEAK." CONNECTIONS CHECKED AND TAPED WITHOUT FURTHER ALARMS. SMALL AMOUNT OF DRIED BLOOD SPOTS NOTED IN TUBING AT 0130 ON 3/7/96. IABP ALARMED "BLOOD DETECTION" AND CEASED TO FUNCTION. NO FRANK BLOOD NOTED AT SITE OR IN TUBING. DR NOTIFIED AND CATHETER REPLACED WITHOUT OBVIOUS RUPTURE IN CATHETER.
ADD'L INFO REC'D FROM MFR 3/28/01: MFR WOULD LIKE TO INFORM FDA THAT THE COMPLAINANT DID NOT CONTACT THEM DIRECTLY AT THE TIME OF THE COMPLAINT, AND THIS IS THE FIRST TIME MFR HAS BEEN INFORMED OF THIS INCIDENT. SINCE THE INCIDENT REPORT DOES NOT INCLUDE A LOT NUMBER, IT IS VERY DIFFICULT TO TRACE THE RECORDS TO THE SPECIFIC LOT. MFR HAS REVIEWED THE RECORDS BEFORE AND AFTER THE INCIDENT DATE AND CANNOT SEE ANYTHING UNUSUAL IN THE MFG OF THE PRODUCT. ADDITIONALLY, MFR HAS MANUFACTURED AND SOLD SEVERAL THOUSAND ENDOMETRIAL CURETTES EACH YEAR SINCE 1995 AND HAS NEVER RECEIVED COMPLAINTS OF A SIMILAR NATURE.
PT SEEN ON 6/26/96 FOR PACEMAKER EVALUATION. TELEMETERED LEAD IMPEDANCE SHOWED 140 OHMS. PACING LEAD IS ON ALERT FOR INSULATION FAILURE WHICH IS SUGGESTED BY LEAD IMPEDANCES LESS THAN 300 OHMS. LEAD REPLACEMENT SCHEDULED FOR 7:30 AM 7/9/96. LEAD IMPEDANCE: 4/24/91 450 OHMS, 5/8/95 572 OHMS, 6/26/96 140 OHMS WITH MAGNET RATE OF 70 PPM, NOT 85.
AFTER STANDARD STERILE PLACEMENT OF # 24G 6" CATHETER IN LEFT BASILIC VEIN AND FLUSHING OF CATHETER WITH 2CC NS, PT EXPERIENCED: "FEELING SAD," FACE FLUSHED, C.P. S.O.B., GRAY COLOR TO FACE, HBP, TACHYCARDIA WITHIN 5 MIN. CATHETER REMOVED IMMEDIATELY, 911 CALLED, PT IN SUPINE POSITION. PT TRANSPORTED TO ER WITHIN 15-30 MIN OF EPISODE, AFTER TREATMENT IN HOME BY PARAMEDICS. PT ADMITTED TO HOSP FOR R/O MI AND PE. ALL SYMPTOMS SUBSIDED AFTER 1-2 HRS IN HOSP. ALL DIAGNOSTIC TESTS IN HOSP WERE NORMAL.
WHILE PACING MODE WAS ENGAGED THE DEVICE BEGAN "FLASHING SERVICE", DROPPING CUT OF PACING MODE, AND WOULD NOT RECHARGE. THE BATTERIES WERE CHANGED WITHOUT IMPROVEMENT AND THE UNIT WOULD WORK FOR A SHORT TIME IF TURNED OFF THEN ON AGAIN. PT WAS A FULL CODE AND ASYSTOLIC DURING PROCEDURE - NO RETURN OF RYTHM.
A 24-YR-OLD BLACK FEMALE ADMITTED TO THE HOSP ON 6/19/96 WITH DIAGNOSIS OF CEREBRAL HEMORRHAGE; ESRD ON MAINTENANCE HEMODIALYSIS. SHE REQUIRED "NO HEPARIN" DIALYSIS BECAUSE OF HER NEUROLOGICAL STATUS. DURING HEMODIALYSIS ON 6/22/96, THE NURSE PROVIDING THE DIALYSIS TREATMENT HAD EXPERIENCED PROBLEMS WITH BLOOD CLOTTING, NECESSITATING CHANGING OF THE AV BLOOD LINES AND DIALYZER. FINALLY WITH INCREASING VENOUS PRESSURES SUDDENLY RISING AGAIN ON THE DIALYSIS MACHINE THE DUAL LUMEN CATHETER WAS CHECKED TO VERIFY PATENCY OF THE VASCULAR ACCESS. BLOOD WAS ASPIRATED AND DISCARDED FROM THE CATHETER PORTS WITH NO CLOTS NOTED. WHILE ASPIRATING AND RE-INSTILLING BLOOD TO VERIFY SMOOTH INFLOW, THE CATHETER RUPTURED AT THE SITE OF THE JOINING OF THE TWO LUMENS. A FINE MIST OF BLOOD SPRAYED APPROX SIX FEET AROUND THE PT. BLOOD LOSS WAS MINIMAL, BUT AN AIR LEAK WAS NOTED WHEN AGAIN ASPIRATING FROM THE PORTS. THE CATHETER WAS CLAMPED BELOW THE TEAR TO PREVENT QUESTIONABLE POTENTIAL AIR EMBOLISM AND ALSO DETER A SOURCE OF CONTAMINATION/INFECTION FOR THE PT. A SURGEON WAS NOTIFIED TO REMOVE THE CATHETER ASAP PER ORDER OF THE NEPHROLOGIST. THE NEPHROLOGIST WAS AT THE PT'S BEDSIDE DURING THIS INCIDENT AND STATED THE NURSE FORCEFULLY INJECTED INTO THE PORT CAUSING THE RUPTURE. THE NURSE DENIES THIS RPTR WAS IN THE UNIT BUT DID NOT WITNESS THIS OCCURRENCE. THE CO WAS CONTACTED TO INFORM AND ASCERTAIN IF OTHER CATHETER RUPTURES HAVE BEEN REPORTED AND ALSO TO PROVIDE A RESOURCE IN DETERMINING IF EXCESSIVE FORCE HAD BEEN UTILIZED. ALTHOUGH MULTIPLE PROCEDURES WERE REQUIRED BY THE SURGEON, RADIOLOGIST, AND NEPHROLOGIST TO PLACE ANOTHER VASCULAR ACCESS INTO THE PT, SUCCESSFUL CATHETER PLACEMENT WAS PROVIDED ON 6/25/96. PT IS PRESENTLY DIALYZING IN UNIT WITHOUT DIFFICULTY. LUCKILY NO ADVERSE PT RESPONSE RESULTED FROM THIS INCIDENT.
PT HAD LAPAROSCOPIC CHOLECYSTECTOMY - TIP OF DISSECTOR BROKE OFF AND WAS RETAINED IN THE ABDOMEN. X-RAY CONFIRMED. NO HARM TO PT, NO THERAPEUTIC INTERVENTION.
PT'S CATHETER IS INSERTED BY A RESPIRATORY THERAPIST IN DR'S OFFICE BIWEEKLY. THIS ONE WAS INSERTED ON A FRIDAY AFTERNOON. THE FLANGE IS BENT IN THE WRONG DIRECTION. EACH TIME PT SWALLOWED OR SOMETHING TOUCHED THE END, THE CENTER PUSHED AGAINST PT'S TRACHEA. PT COULD NOT HAVE THIS CHANGED UNTIL MONDAY MORNING. IMAGINE THE DISCOMFORT IF SOMEONE PRESSING YOUR WINDPIPE INTERMITTENTLY FOR ALMOST 36 HRS. THIS IS DEFECIVE EQUIPMENT.
DISPOSABLE CLIP APPLIER DURING LAP CHOLE PROCEDURE WOULD NOT FORM ACCEPTABLE CLIPS. SAMPLE OF MISFORMED CLIP AVAILABLE. DEVICE TO BE RETURNED TO CO FOR EVALUATION.
DISPOSABLE CLIP APPLIER DURING LAP CHOLE PROCEDURE WORKED FINE UNTIL ABOUT HALF WAY THROUGH AND THEN BEGAN TO MISFIRE. WOULD NOT FORM ACCEPTABLE CLIPS THEREAFTER. DEVICE TO BE RETURNED TO CO FOR EVALUATION.
SEVENTY-NINE YEAR OLD MALE WHO REQUIRED A PENILE PROSTHESIS REMOVAL FOR IMPENDING EROSION AND INFECTION.
CAREGIVER (PT'S MOM) NOT ABLE TO PROPERLY PRIME TUBING. IT SEEMS CERTAIN LOTS OF TUBING CAN NOT HOLD PRIMING FLUID CAUSING AIR IN TUBING. MAY BE USER ERROR.
MFR'S RESPONSE RECEIVED ON 9/30/96: DIVISION QUALITY ASSURANCE HAS EXAMINED REPORT. THE CONDITION REPORTED IS ASSUMED VALID, ALTHOUGH NO SAMPLE HAS BEEN RECEIVED FOR EVALUATION. THE ACTUAL SUBSTANCE THAT WAS OBSERVED IN THE BARRELS WAS SILICONE LUBRICANT. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR THE PROPER FUNCTION OF DISPOSABLE HYPODERMIC PRODUCTS. THIS CONDITION OCCURS WHEN SILICONE, USED ON THE INTERIOR OF THE SYRINGE BARREL TO FACILITATE PLUNGER MOVEMENT, IS INADVERTENTLY OVERSPRAYED ON THE OUTSIDE OF THE SYRINGE. THESE SYRINGES SHOULD HAVE BEEN REMOVED FROM PRODUCTION. CO RECOGNIZES THE DIFFICULTIES THIS CONDITION HAS CAUSED CO APOLOGIZES FOR THEM. AS A CORRECTIVE ACTION CO HAS INSTITUTED IMPROVED CONTROLS OVER THE SILICONE APPLICATION SYSTEMS USED ON THESE PRODUCTS. CO EXPECTS THESE CONTROLS WILL SIGNIFICANTLY REDUCE THIS UNACCEPTABLE CONDITION.
BAG MALFUNCTIONED UPON TRANSFER OF PT FROM OR TO ICU, AND A BAG WAS PLACED ON INTUBATED PT. GREAT DEAL OF RESISTANCE NOTED. RPTR ZEROED PEEP VALVE. NO CHANGE, RPTR REMOVED PEEP VALVE, NO CHANGE. RPTR RECONNECTED PT TO ANESTHESIA MACHINE, AND GOT A NEW BAG PLACED ON TO PT'S ET TUBE AND PROBLEM WAS CLEARED. PLEASE NOTE BAG WAS SOILED FROM PREVIOUS USE ON SAME PT AND EXPIRATORY VALVE WAS MALFUNCTIONING.
DURING THE FACILITY ANNUAL LICENSE MEDICARE/MEDICAID SURVEY, CONDUCTED DURING THE WEEK OF 6/11/96 THROUGH 6/14/96, TWO RESIDENTS WERE NOTED TO HAVE BEEN INJURED AS A RESULT OF BED RAILS. THESE RESIDENTS REQUIRED TRANSFER TO THE HOSP FOR MEDICAL TREATMENT. THERE WERE NO DEATHS FROM THESE INJURIES. REVIEW OF THE MAINTENANCE RECORDS NOTED 17 INSTANCES OF BROKEN BED RAILS. REVIEW OF THE BEDRAIL, FOR ONE OF THE RESIDENTS WHO SUSTAINED AN INJURY WAS NOTED TO BE PARTIALLY BROKEN.
THE EMPTY 500ML CONTAINER WAS FILLED WITH SALINE AND VANCOMYCIN. THE CONTAINER WAS LEAKING AT THE PORT. (LABEL).
WHILE TRANSFERRING RESIDENT IN ELECTRIC LIFT, THE RIGHT LEG STRAP (LIFT SHEET) RELEASED AND THE RESIDENT SLID OUT OF THE SLING ONTO THE FLOOR. SHE WAS EXAMINED FOR INJURIES IN THE HOSP. SHE RECEIVED A HEMATOMA ON THE BACK OF HER HEAD. CO REP WAS NOTIFIED AND WOULD BE OUT TO CHECK THE SLING. THIS SITUATION OCCURRED ON 5/14/96.
SYRINGE-NEEDLE WAS PACKAGED WITHOUT NEEDLE CAP.
4/3/96 LAB PT RESULTS WERE 24.0. RN DREW BLOOD C BLUE TOP TUBE. MD WAS CALLED ON 4/4/96 AND VALUES WERE REPORTED. HE REPEATED PROTIME ON PT WITH RESULTS BEING 14.0, A 10 POINT DIFFERENCE. PT'S COUMADIN DOSAGE WAS BEING ADJUSTED ACCORDING TO LAB RESULTS. CALLED MULTIPLE LAB CO'S WITH ALL STATING TUBES MUST FILL COMPLETELY FOR TEST TO BE ACCURATE. RPTR TESTED TUBES AND FOUND THAT THEY WERE ONLY HALF FILLING OR FILLING 3/4'S FULL. PT IN HOSP 4/4/96 WITH CVA DUE TO BLOOD CLOT. CLIENT HAD PLACEMENT OF FILTER IN INFERIOR VENA CAVA PRIOR TO ADMINISTRATION TO HOME HEALTH. HAD NUMEROUS BLOOD CLOTS PRIOR TO THIS INSERTION.
04/03/96 PT RESULTS WERE 24.0. RN DREW BLOOD WITH BLUE TOP TUBE. MED WAS CALLED ON 4/4/96 AND VALUES WERE REPORTED. HE REPEATED PROTIME ON PT WITH RESULTS BEING 14.0, A 10 POINT DIFFERENCE. PTS COUMADIN DOSAGE WAS BEING ADJUSTED ACCORDING TO LAB RESULTS. CALLED MULTIPLE LAB CO'S WITH ALL STATING TUBES MUST FILL COMPLETELY FOR TEST TO BE ACCURATE. RPTR TESTED THEIR TUBES AND FOUND THAT THEY WERE ONLY HALF FILLING OR FILLING 3/4'S FULL. PT HOSPITALIZED 4/4/96 WITH CVA DUE TO BLOOD CLOT. CLIEQNT HAD PLACEMENT OF FILTER IN INFERIOR VENA CAVA PRIOR TO ADMINISTRATION TO HOME HEALTH. HAD NUMEROUS BLOOD CLOTS PRIOR TO THIS INSERTION.
3 LITER TPN BAGS. NOT SEALED AT BOTTOM (CRIMPED PLASTIC) RESULTING IN LEAKAGE AND OPEN IV SYSTEM.
BETWEEN THE DATES OF 5/30/96 AND 6/7/96 RPTR EXPERIENCED THREE CATHETERS THAT GOT STUCK WHEN PULLED OUT. IN EACH CASE A PHLEBITIS DEVELOPED, UPON REMOVAL OF THE CATHETER (1-2" ABOVE INSERTION SITE). RPTR WAS ABLE TO REMOVE APPROX. 2/3 OF THE LENGTH OF THE CATHETER, BEFORE THE CATHETER GOT STUCK. IN AN ATTEMPT TO REMOVE THE CATHETERS, RPTR USED A HEATING PAD TO DILATE THE VEIN. IN ALL CASES THEY HAD TO SEND THE PT TO THE HOSP. FOR REMOVAL. IN TWO OF THE THREE CASES, RPTR WAITED 24 HOURS AND ATTEMPTED ONCE AGAIN TO REMOVE THE CATHETER PRIOR TO SENDING THEM TO THE HOSP.
CONCLUSIONS AND COMMENTS: THE FOREIGN SUBSTANCE WAS LOCATED INSIDE THE SLEEVE OF THE HARDPACK NOT INSIDE THE BARREL WHERE IT MIGHT COME INTO CONTACT WITH FLUIDS. THE PROBLEM WAS DISCUSSED WITH PRODUCTION PERSONNEL; MORE FREQUENT CLEANING OF AIR LINES WAS SUGGESTED AS A REMEDY. A SEARCH OF COMPLAINT DATABASE DID NOT UNEARTH ANY SIMILAR COMPLAINTS.
THE DLSC REPORT IDENTIFIED THE FOREIGN SUBSTANCE AS CONSISTENT WITH MEDICAL-GRADE SILICONE AND CONTAINING WHAT APPEARD TO BE DIRT CLUMPS. THE FOREIGN SUBSTACNE WAS IN ALL INSTANCES WAS LOCATED INSIDE THE SLEEVE OF THE SYRINGE HARDPACK OR PACKAGE, NOT INSIDE THE BARREL WHERE IT MIGHT COME INTO CONTACT WITH FLUIDS. STATED DIFFERENTLY, ALL THE FOREIGN MATTER WAS EXTERNAL TO THE SYRINGES STERILE FLUID PATHWAY.
THE PT IS A 33 YR OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN MAY OF 1985 USING THE GEL FILLED PROSTHESIS. THE PT THEN NOTED INSIDIOUS DEVELOPMENT OF FATIGUE, ARTHRALGIA, HAIR LOSS, DRY EYES, MEMORY LOSS AND ACHINESS IN THE BREAST, ESPECIALLY ON THE RIGHT SIDE. ON PHYSICIAL EXAM, SHE HAS A CLASS 4 CAPSULAR CONTRACTURE ON BOTH BREASTS. XEROMAMMOGRAM AND ULTRASOUND SHOWED A HIGHLY PROBABLE LEFT INTRACAPSULAR RUPTURE. THE RIGHT IMPLANT IS PROBABLY INTACT. BECAUSE OF PAIN AND FINALLY PROBABLE RUPTURE ON THE LEFT SIDE AS WELL AS CONTRACTURE, IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS. TOTAL CAPSULECTOMY IS NECESSARY BECAUSE OF SYSTEMIC SYMPTOMS, PAIN AND CONTRACTURE.
THE PT IS A 48 YR OLD WHITE FEMALE WHO UNDERWENT BILATERAL BREAST AUGMENTATION IN DECEMBER OF 1987 USING ANOTHER CO'S SALINE IMPLANT 325CC. AFTER IMPLANTATION, THE PT'S HEALTH BEGAN DETERIORATING WITH JOINT PAIN, ARM PAIN, MIGRAINE'S, NAUSEA, VOMITING, AND FATIGUE. SHE HAS BEEN DIAGNOSED WITH FIBROMYALGIA. ON PHYSICAL EXAM, SHE HAS NO CONTRACTURE IN HER BREASTS. THERE IS PAIN IN THE LEFT AXILLA BUT THERE IS NO SILICONE LYMPHADENOPATHY. BECAUSE OF SYSTEMIC SYMPTOMS AND LOCAL PAIN SYMPTOMS, THE PT DESIRES IMPLANT REMOVAL. TOTAL CAPSULECTOMY IS MEDICALLY NECESSARY BECAUSE THE CAPSULE CONTAINS IMPLANT COMPONENTS WHICH THE PT MAY BE REACTING TO.
TUBE FEEDING STARTED POSTOP 6/3/96. TUBE WAS LEAKING AT THE HUB OF BALLOON PORT ON THE TUBE. TUBE WAS PLACED IN SURGERY BY PHYSICIAN ON 6/3/96. THE BALLOON PORTS ARE LOCATED NEAR THE CONNECTION POINTS/OPENING OUTSIDE THE PT. COMPLAINT BY SURGERY STAFF WITH THE CO IS THEY DO NOT HAVE AN EXPIRATION DATE ON THE PACKAGE. THE MARKETING PERSON WITH THE TUBE MFR STATED IF WE KEPT THESE LONGER THAN ONE YEAR, HOSP NEEDED TO REPLACE THEM AT HOSP'S COST. CO DOES NOT HAVE A SALES REP WE CAN WORK THROUGH. CLINICAL REP FROM CO DOES NOT RETURN THE CALLS FROM SURGICAL NURSE MANAGER.
NEWBORN ADMITTED TO THE INTENSIVE CARE UNIT FOR SEPTIC WORK-UP. INTRAVENOUS ANTIBIOTICS ORDERED AND IV ACCESS FOR MEDICATION ADMINISTRATION STARTED. INSERTION OF A 24 GAUGE, 3/4 IV ANGIOCATHETER INTO RIGHT HAND BY RN. UNABLE TO ADVANCE CATHETER AND WAS REMOVED. UPON REMOVAL OF THE CATHETER UNIT RN FELT A "POP". IMMEDIATE INSPECTION OF THE CATHETER UNIT NOTED CATHETER NOT INTACT. NEWBORN'S RIGHT WRIST AND ANTECUBITAL MANUALLY TORNIQUETED. EMERGENCY SURGICAL CUT-DOWN OF SITE PERFORMED OF IV INSERTION SITE ON RIGHT HAND. REMOVAL OF 0.4CM FOREIGN BODY APPEARING TO BE CATHETER TIP. SITE SUTURED. SUTURES REMOVED 6/9/96 WITH WOUND SITE INTACT AND HEALING.
PT HAD JUST UNDERGONE A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. THE DRAPES WERE BEING REMOVED AND IT WAS NOTED THAT THE PT HAD INCURRED A BURN TO THE LEFT GROIN CREASE. THE AREA WAS BROWN IN THE CENTER ABOUT 3.5CMX0.7CM WITH AN OUTER WHITE AREA ABOUT 7CMX3CM.
CAPSULAR CONTRACTURE, LEFT AND BILATERAL RUPTURED IMPLANTS.
CAPSULAR CONTRACTURE BILATERALLY AND RUPTURED BREAST IMPLANT WERE NOTED IN THE RIGHT BREAST.
IN PREPARATION FOR A STEM CELL REINFUSION, THE HEALTH CARE PROFESSIONAL PLACED THE BAG OF PERIPHERAL BLOOD STEM CELLS ON TOP OF THE LIQUID NITROGEN TRANSPORT CANNISTER SO THAT HE COULD OPEN A STERILE BAG TO PUT THE BAG IN. THE BAG EXPLODED WITH A LOUD POUP SENDING SHARDS OF FROZEN PRODUCT THROUGHOUT THE ROOM. THE DONOR WAS TAKEN TO THE OPERATING ROOM THE FOLLOWING DAY TO EXTRACT ANOTHER DONATION. THE SECOND DONATION WAS INFUSED. NO HARM CAME TO THE PT.
COMPLETE RUPTURE OF IMPLANT ON LEFT SIDE, WITH CAPSULAR CONTRACTURE. EXTENSIVE SILICONE GEL BLEED INSIDE CAPSULE ON RIGHT SIDE AND CAPSULAR CONTRACTURE.
TRANSDUCER TO RADIAL ARTERY LINE BROKEN AT SITE AT TOP OF TRANSDUCER. TRANSDUCER AND RADIAL ARTERY LINE HAD BEEN IN PLACED FOR 24 HOURS. PT HAD BEEN MOVING A LITTLE IN BED WHEN BREAKAGE OF TRANSDUCER OCCURRED. LINE BLED BACK INTO TUBING CAUSING NO ADVERSE EFFECT.
SEVERE BRACHYCARDIA LEADING TO CARDIAC AND RESPIRATORY ARREST APPROX. 90 SECONDS AFTER INSERTION OF BONE CEMENT IN SURGERY. PT WAS RESUSICTATED APPROX. 45 MINUTES UNSUCCESSFULLY AND WAS PRONOUNCED DEAD.
PT HAD 1ST MTPJ SURGERY ON 7/8/93 WITH IMPLANT PLACEMENT. ON 10/24/94 SHE WAS READMITTED FOR REMOVAL OF THE DISTAL PORTION OF THE IMPLANT DUE TO IMPLANT FAILURE AFTER SHE SUFFERED TRAUMA TO THE AREA. THIS SURGERY LEFT HER WITH A "KELLER" TYPE BUNION PROCEDURE AND SHE DID WELL UNTIL ONE MONTH LATER. HER SHOE RUBBED AGAINST THE IMPLANT, PAIN RETURNED AND HAS REMAINED CONSTANT. HER FOOT HAS BEEN STEPPED ON SEVERAL TIMES AS WELL AS BUMPING IT AGAINST OBJECTS. HAVE TRIED CONSERVATIVE APPROACH. SURGERY ON 6/4/96 FOR REMOVAL METATARSAL IMPLANT RIGHT FOOT. POST OP DX. SESAMOIDITIS AND NEURITIS WITH ASSOCIATED INTERMETATARSAL BURSAE Z DEGREES. IMPLANT FAILURE RIGHT 1ST MTPJ.
PT'S TRACHEOSTOMY TUBE CUFF HAD BEEN FILLED WITH APPROX. 12 CC STERILE WATER. TRACH TUBE WAS PULLED AND REPLACED. A SMALL PIN HOLE WAS FOUND AT THE UNION BETWEEN THE CUFF AND THE LINE COMING FROM THE PILOT BALLOON.
ABDOMINAL HYSTERECTOMY ON 5/28/96. VAGINAL HEMORRHAGE IN RECOVERY ROOM. RETURN TO OR REVEALED SUTURE LINE OF VAGINAL CUFF HAD COMPLETELY SEPARATED. STAPLER USED FOR SUTURE LINE WITH APPARENT FAILURE. SUTURE LINE OPEN WITH FREE STAPLES FOUND.
ON 5/15/96 ABDOMINAL HYSTERECTOMY. ON 5/16/96 VAGINAL HEMORRHAGE  REQUIRING RETURN TO OR AND 4 UNITS OF BLOOD. VAGINAL CUFF SUTURE LINE COMPLETELY SEPARATED. STAPLER USED WITH APPARENT FAILURE. SUTURE LINE OPEN WITH FREE STAPLES FOUND.
PT HAD RUPTURED SILICONE IMPLANTED. THEY WERE REMOVED AND REPLACED WITH SALINE IMPLANTS.
THE PT WAS A 40 YR OLD WOMAN WHO HAD BILATERAL BREAST AUGMENTATION IN MAY OF 1988, USING IMPLANTS. THE LEFT IMPLANT WAS 275CC, RIGHT IMPLANT 325CC. THE PT HAD LONGSTANDING CAPSULAR CONTRACTURE AND BURNING PAIN IN THE BREAST. THE PT DID NOT HAVE ANY SIGNIFICANT SYSTEMIC SYMPTOMS, SHE WOULD LIKE BREAST IMPLANT REMOVAL.
THE PT IS A 39 YR OLD WOMAN WHO HAD BILATERAL BREAST AUGMENTATION IN MARCH OF 1986 UNDER THE BREAST DURING AN ABDOMINOPLASTY INCISION. PT COMPLAINS OF COLD INDUCED BREAST AND NIPPLE PAIN, SUDDEN EPISODES OF SHORTNESS OF BREATH NOT ASSOCIATED WITH ANXIETY ATTACKS, FREQUENT YEAST INFECTIONS, NOT NECESSARILY ASSOCIATED WITH ANTIBIOTIC USE. ON PHYSICAL EXAMINATION, SHE HAS CLASS IV CONTRACTURES IN BOTH IMPLANTS. ULTRASOUND AND XEROMAMMOGRAM EXAM SHOWS BOTH IMPLANTS TO BE RUPTURED. BECAUSE OF RUPTURE, CONTRACTURE, PAINFUL IMPLANTS, THE PT DESIRES IMPLANT REMOVAL. A TOTAL CAPSULECTOMY IS NECESSARY BECAUSE THE IMPLANTS ARE HIGHLY SUSPECTED TO BE RUPTURED.
THE PT IS A 44 YR OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 1977. THESE IMPLANTS WERE REPLACED IN 1988 BECAUSE OF CAPSULAR CONTRACTURE AND RUPTURE. THE PT DEVELOPED SYSTEMIC SYMPTOMS IN 1989 WITH RECURRENT FLULIKE SYMPTOMS, CHILLS, SWEATS, ACHES, AND FATIGUE. THE IMPLANT HAS ALSO BECOME QUITE CONTRACTURE. SHE HAS BREAST PAIN BILATERALLY WHICH RADIATES FROM THE NIPPLE AREA TO THE AXILLA. THE PT HAS ALSO BALANCE DISTURBANCE, DRY EYES, DRY MOUTH, AND ALOPECIA. BECAUSE OF THESE SYSTEMIC SYMPTOMS, SHE HAS BEEN DIAGNOSED WITH ATYPICAL CONNECTIVE TISSUE DISEASE ASSOCIATED WITH SILICONE BREAST IMPLANT. BECAUSE OF CONTRACTURE AND SYSTEMIC SYMPTOMS, IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS IN THE EVENT THAT THE IMPLANTS MAY HAVE CAUSED THESE SYMPTOMS. TOTAL CAPSULECTOMY IS MEDICALLY NECESSARY BECAUSE THE CAPSULE CONTAINS SILICONE WHICH THE PT MAY BE REACTING TO.
THE PT IS A 47 YR OLD WOMAN WHO HAD RIGHT BREAST CANCER IN 1987. SHE HAD A RIGHT MODIFIED RADICAL MASTECTOMY IN 1987. SHE THEN BEGAN HER RECONSTRUCTION IN 1989 WITH PLACEMENT AND EXPANDER ON THE RIGHT IN 1991. SHE HAD TWO STACKED TEXTURED GEL FILLED BREAST IMPLANTS ON THE RIGHT AND ONE TEXTURED GEL FILLED BREAST IMPLANT ON THE LEFT. SHE HAD PAIN IN HER RIGHT AXILLA AFTER EXPANDER PLACEMENT IN 1989. SHE THEN DEVELOPED BURNING PAIN TWO MONTHS AFTER PLACEMENT OF STACKED IMPLANTS. THE LEFT SIDE WAS FREE OF PAIN UNTIL THE LEFT IMPLANT. SHE ALSO HAS BOUTS OF NAUSEA, POOR SHORT TERM MEMORY, POOR SLEEP, PAIN IN BOTH BREASTS IS DESCRIBED AS SEVERE AND INTOLERABLE. ON PHYSICAL EXAM SHE HAS A CLASS III CONTRACTURE AND SHE IS TENDER THROUGHOUT THIS RIGHT IMPLANT. ON THE LEFT SIDE, THERE IS A CLASS IV CONTRACTURE WITH SIGNIFICANT TENDERNESS AROUND THE IMPLANTS. BECAUSE OF SEVERE PAIN CONTRACTURE, REMOVALLY IS MEDICALLY NECESSARY. SINCE THE IMPLANTS ARE TEXTURED SURFACE VARIETY, CAPSULECTOMY IS MEDICALLY NECESSARY.
ON 4/17/96, PT HAD PORT INSERTED. RE:PT DX BREAST CARCINOMA; REQUIRING VENOUS ACCESS/MED. PT WAS ADMITTED TO HOSP 6/13/96; HX PT RECEIVING CHEMOTHERAPY. ONE WEEK AGO A LEAK FROM THE PORT WAS OBSERVED. ON 6/12/96, SHE WAS FEBRILE 100% DEGREES FAHRENHEIT. C/O PAIN AROUND PORT SITE. THE DECISION WAS MADE TO REMOVE THE PORT DUE TO POSSIBLE INFECTION. DURING SURGICAL PROCEDURE, (THE REMOVAL OF DEVICE), IT WAS NOTED THAT THE CATHETER APPEARED SHEARED OFF IN PT; EDGES IRREGULAR. CHEST X-RAY DONE PT TO ICU; TRANSFERRED TO ANOTHER MED CTR FOR REMOVAL OF CATH TIP; PT RETURNED TO HOSP 6/13-2400. PT DISCHARGED TO HOME IN THE AM OF 6/14/96.
ATTEMPTED TO PLACE #16 FOLEY CATH SEVERAL TIMES, BUT BALLOON DEFLATED SLOWLY. BUT WHEN DEFLATED, VALVE WAS NOT FUNCTIONING. AFTER SEVERAL ATTEMPTS, CATHETER WAS CUT BELOW VALVE, BUT BALLOON STILL DID NOT DEFLATE. PHYSICIAN HAD TO PUNCTURE BALLOON WITH GUIDE WIRE TO REMOVE FOLEY CATHETER. PT EXPERIENCED SOME BLOOD LOSS, BUT VERY MINIMAL.
WHILE ON A PT BEING VENTILATED THERE WAS AN ALARM ON THE HUMIDIFIER HEATER WHICH INDICATED "HEATER WIRE ALARM". THE HEATER TEMP WAS READING 36 DEGREES CELSIUS AT THE TIME WITH THE CHAMBER CONTROL SET AT -1. UPON TROUBLE SHOOTING THE ALARM CONDITION THE THERAPIST CHECKED THE CONNECTION BETWEEN THE HEATER CIRCUIT ADAPTER AND THE BREATHING CIRCUIT ON THE EXPIRATORY SIDE OF THE CIRCUIT AND FOUND THE CIRCUIT WIRES DISCONNECTED AND MELTED AT THE ENDS (BREATHING CIRCUIT WIRES). THE UNITS WERE IMMEDIATELY TAKEN OUT OF SERVICE. THERE WAS NO ADVERSE EVENT OR INJURY TO THE PT.
RPTR WAS RETOPPING A GLASS EDTA TUBE, WHEN THE TUBE SHATTERED. IT LACERATED HER RT INDEX FINGER-REQUIRING 8 STITCHES. RETURNED TO LIGHT DUTY ONLY AFTER INCIDENT.
INTRA-AORTIC BALLOON PUMP (IABP) PLACED IN CARDIOVASCULAR LAB. PT SUBSEQUENTLY TAKEN TO SURGERY FOR EMERGENCY CORONARY ARTERY BYPASS. AT CONCLUSION OF PROCEDURE WHEN THEY WENT TO PLACE PT BACK ON IABP, IT WOULD NOT WORK. PT REMAINED ON HEART/LUNG UNTIL ANOTHER IABP COULD BE BROUGHT TO THE OPERATING ROOM.
GRASPER'S JAWS BROKE DURING SURGICAL PROCEDURE INSIDE PT'S ABDOMEN. PIECES WERE RETRIEVED. NO INJURY TO PT. RETRIEVED PIECES DISCARDED.
HYSTERECTOMY, NECK AND SHOULDER TIGHT AND SORE ALL THE TIME, PAIN AND BURNING UNDER RIGHT ARM, LOSS OF MEMORY, HEART RACES AND SKIPS, LUPUS AND FIBROMYALGIA. IMPLANTED 11/13/78.
RESIDENT FOUND ON THE FLOOR BY CNA. WRIST RESTRAINT IN PLACE BUT BACK OF WHEELCHAIR FOUND ON THE FLOOR WITH PT. NO SERIOUS INJURY FOUND. MULTIPLE ABRASIONS AND CONTUSIONS. IN EXAMINING THE CHAIR IT WAS FOUND THAT RESTRAINT IS APPLIED AROUND THE PT AND THE BACK OF THE CHAIR, WHEN THE PT PULLS FORWARD AND UPWARD IT WILL RELEASE THE BACK OF THE CHAIR COMPLETELY FROM THE REST OF THE CHAIR. THIS LADY HAD FALLEN OUT. PTS USED TO BE MADE AWARE OF THIS POSSIBILITY. IF THE RESTRAINTS ARE AROUND THE POSTS OF THE CHAIR THIS COULD NOT HAPPEN.
INTERFERENCE SCREW GOT LOST INSIDE THE PT'S TIBIAL BONE AREA DURING SURGERY. ATTEMPTED TO RETRIEVE WITH C-ARM ASSISTANCE. RETRIEVED BY SURGEON. NO LONG TERM PT INJURY NOTED HOWEVER RETRIEVAL TIME EXTENDED SURGERY BY 2 HRS. TORNIQUET UP ENTIRE TIME.
STAFF FOUND G-TUBE IN RESIDENT'S BED WITH BULB APPARENTLY DEFLATED. DEVICE WAS REPLACED WITH NEW DEVICE. STAFF DESCRIBED THE BULB AS "BURST" ALLOWING TUBE TO DISLODGE.
NEURO PULSE GENERATOR NOT WORKING. IT HAD BEEN READJUSTED AND CHECKED BEFORE IT WAS DECIDED THAT IT HAS TO BE REPLACED. NO INJURY TO PT.
A BREAST IMPLANT WAS OPENED AND WHEN PHYSICIAN STARTED TO FILL WITH SALINE, HE NOTED THERE WAS A HOLE IN THE IMPLANT. NO INJURY TO PT-DEFECT WAS NOTICED PRIOR TO IMPLANTING THE DEVICE.
IMPLANTABLE SPINE STIMULATOR RECEIVER AND LEAD REMOVED AND REPLACED. DEVICE APPEARS RUSTED.
FILTER USED DURING BYPASS, DEVELOPED BLOOD LEAK FROM TOP OF FILTER WHEN BLUE CAP REMOVED.
DURING LAP CHOLE, ACTIVE CORD WAS SMOKING AND COMPLETELY BURNED THROUGH THE CORD NEAR ACCESSORY CONNECTION. SPATULA HAD PIN HOLE DEFECT IN SHEATH, AND AREA NEAR SPATULA. ACTIVE CORD WAS CHANGED, HOWEVER THERE WERE STILL PROBLEMS WITH SHEATH. NO PT INJURY.
PT ON VENTILATOR WAS EXPERIENCING LOW O2 SATURATION PROBLEM. VENT O2 SETTING ADJUSTED FOR 100% O2. SUBSEQUENTLY THE VENT WAS ONLY DELIVERING 43% O2. PT SATS CONTINUED TO DROP; CHECKED VENT'S O2 OUTPUT, NOT AT SETTING SELECTED. CHANGED OUT VENT. THE PT HAD BEEN EXTUBATED SOME 2 1/2 HRS EARLIER, BUT THE VENTILATOR, A NEW CO VENTILATOR WHICH THE PT HAD BEEN VENTILATED WITH FOR SOME FIVE DAYS (WITHOUT DIFFICULTY), REMAINED AT THE PT'S BEDSIDE. THE PT, WHO WAS IN RESPIRATORY FAILURE WITH A PACO2 OF 71 MM, WAS GIVEN 1 MILLIGRAM OF INTRAVENOUS MIDAZOLAM AND REINTUBATED WITHOUT DIFFICULTY. HE WAS MANUALLY VENTILATED WITH A SELF INFLATING BAG (>15 LITERS PER MIN OXYGEN SATURATION), SPO2 ON A PULSE OXIMETER READ BETWEEN 94 AND 96%; HIS BLOOD PRESSURE FELL TO 70 TO 90 SYSTOLIC (FROM 130 TO 140 SYSTOLIC), AS THE FREQUENCY AND TIDAL VOLUMES OF HIS INSPIRED BREATHS WERE INCREASED IN AN ATTEMPT TO IMPROVE HIS SPO2. HE WAS PLACED ON THE VENTILATOR (ON 100% OXYGEN), AND SUCTIONED FREQUENTLY FOR LARGE VOLUMES OF LIGHT GREEN, THICK MUCOUS; HIS CHEST MADE APPROPRIATE EXCURSIONS AND HIS EXHALED TIDAL VOLUMES WERE APPROPRIATE FOR THE VENTILATOR SETTINGS. THE PT'S SPO2 THEN FELL TO 86% BUT OCCASIONALLY ROSE TO 98%; CHANGING FINGERS ON THE PULSE OXIMETRY SEEMED TO AFFECT THE SPO2 READING VARIABLY; AN ALBUTEROL NEBULIZER TREATMENT AND FURTHER SUCTIONING IMPROVED HIS WHEEZING AND RHONCHI, WHICH WERE SIGNIFICANT IMMEDIATELY AFTER REINTUBATION, BUT NOT HIS SPO2. NEITHER A PEEP OF 5 CM H2O, NOR ANOTHER PERIOD OF MANUAL VENTILATION IMPROVED HIS SPO2. HIS CHEST X-RAYS (THE FIRST DID NOT SHOW ALL LUNG FIELDS) REVEALED THE ENDOTRACHEAL TUBE TO BE IN THE CORRECT POSITION AND NO PATHOLOGY SUFFICIENT TO EXPLAIN THE SATURATION DIFFICULTIES. BECAUSE OF THE VARIABILITIES IN HIS SPO2 AND ARTERIAL BLOOD GAS WAS DRAWN; IT REVEALED A PAO2 OF 44 MM HG. DURING THIS TIME THE PT RECEIVED A BOLUS OF INTRAVENOUS FLUID AND THE WAVEFORM OF HIS PULSE OXIMETER APPEARED BROADER, INFERRING BETTER PERFUSION. HIS SPO2 FELL TO 79% AND VIGOROUS MANUAL VENTILATION WITH A SELF INFLATING BAG (> 15 LITERS PER MIN OXYGEN FLOWING INTO THE BAG), THIS TIME, IMPROVED THE PT'S SPO2 TO 98%; THE VENTILATOR WAS THEN RECHECKED; THE TIDAL VOLUME AND RATE WERE ACCURATE, HOWEVER, THE VENTILATOR WAS FOUND TO BE GIVING ONLY 35% OXYGEN WHILE THE CONTROL WAS SET ON 100%. A NEW VENTILATOR WAS DONE WELL, AS OF THIS REPORT. SOME 18 HRS LATER.
ON 3/26/96 PT PRESENTED TO ER IN POOR CONDITION WITH NEW ONSET DIABETES MELLITUS WITH DIABETIC KETOACIDOSIS. PT WAS ADMITTED TO THE HOSP FOR AGGRESSIVE FLUID HYDRATION AND INTRAVENOUS INSULIN THERAPY. 3/27/96 PT'S BLOOD SUGAR REMAINS CRITICALLY HIGH. NURSE DISCOVERED CO'S INFUSION PUMP HAD NOT BEEN INFUSING INSULIN OVER THE PAST 12 HRS. INFUSION PUMP INDICATED FLUID WAS INFUSING AND ALSO DISPLAYED A TOTAL VOLUME STATUS. ALARM DID NOT SOUND.
THE PT IS A 43-YR-OLD WOMAN WHO HAD BILATERAL BREAST AUGMENTATION IN 1981, USING SILICONE GEL FILLED BREAST IMPLANTS. IN 1985, SHE DEVELOPED FATIGUE. IN 1989, SHE DEVELOPED RIGHT BREAST SWELLING WHICH WOULD COME AND GO AND JOINT ACHES. AFTER WORKUP BY RHEUMATOLOGIST, THE DIAGNOSIS RELATED WAS A SILICONE RELATED DISORDER. IN 3/94, SHE ALSO DEVELOPED RIGHT-SIDED FACIAL RASH WHICH ALSO EXTENDED TO THE RIGHT UPPER EXTREMITY, NECK, CHEST, AND BACK. HEADACHES AND FATIGUE HAVE CONTINUED TO THE PRESENT TIME. IN ADDITION, THE PT ALSO HAD DIZZY SPELLS. ON PHYSICAL EXAMINATION, SHE ALSO HAS A CLASS III CONTRACTURE ON THE RIGHT AND A CLASS II ON THE LEFT. BECAUSE OF CONTRACTURE WITH SIGNIFICANT PAIN ON THE RIGHT SIDE AND SYSTEMIC SYMPTOMS THAT MAY BE RELATED TO HER IMPLANTS, REMOVAL IS MEDICALLY NECESSARY. CAPSULECTOMY IS ALSO NECESSARY BECAUSE THE CAPSULE CONTAINS SILICONE WHICH THE PT MAY BE REACTING TO.
THE PT WAS A 39-YR-OLD WOMAN WHO HAD A BILATERAL SUBCUTANEOUS MASTECTOMY FOR FIBROCYSTIC DISEASE IN 1989. AT THAT TIME, SHE WAS RECONSTRUCTED WITH A CO GEL FILLED IMPLANT; HOWEVER, THE IMPLANTS REQUIRED REPLACEMENT IN 5/90, BECAUSE OF DEFLATION AND BECAUSE OF POOR SHAPE. AT THAT TIME, A CO IMPLANT WAS REPLACED. THE PT HAD ONE YEAR HISTORY OF HYDRADENITIS IN BOTH AXILLA. THE PT WAS OVERWEIGHT; HOWEVER, SHE DOES COMPLAIN OF FATIGUE, ANXIETY, AND DEPRESSION. ULTRASOUND EXAMINATION AND XEROMAMMOGRAM DEMONSTRATED DEFINITIVE LEFT EXTRACAPSULAR RUPTURE IN ALL FOUR QUADRANTS. BECAUSE OF THE RUPTURE ON THE LEFT SIDE BILATERAL CAPSULECTOMY WAS MEDICALLY NECESSARY. THE CAPSULECTOMY WAS ALSO NECESSARY FOR RUPTURE.
PT WAS SITTING IN WHEELCHAIR AFTER DIALYSIS RUN. HAD DIALYSIS NEEDLES IN ARM WITH CHUX TAPED SECURELY AROUND ARM. PT HAD JUST FINISHED LUNCH WHEN SHE NOTED A POOL OF BLOOD UNDER WHEELCHAIR. FOUND VENOUS NEEDLE HAD BECOME UNCLAMPED.
PT WAS STANDING AT DRAINSIDE AFTER COMPLETION OF DIALYSIS RUN FOR B/P. WAS BEING TRANSFERRED TO ANOTHER CHAIR WITH 15 GAUGE NEEDLES INTACT TO LEFT ARM GRAFT. WHILE TAKING B/P ANOTHER STAFF MEMBER NOTED POOLING ON FLOOR. NOTED THAT CLAMP OF ONE ACCESS NEEDLE UNCLAMPED.
DISTAL END OF GUIDE WIRE (RADIO-OPAQUE TIP) FRACTURED IN THE APPROX MIDDLE OF THE RADIO-OPAQUE PORTION DURING A CORONARY STENT PROCEDURE (MULTIVESSEL). FRACTURED TIP WAS VERY DISTAL. ATTEMPTS TO REMOVE TIP WITH GOOSENECK SNARE WERE UNSUCCESSFUL AND RESULTED IN SMALL CORONARY PERFORATION. THIS REQUIRED SUBSEQUENT PROCEDURES: THERMODILUTION CATHETER ECHO, IABP, AND BALLOON TAMPONADE AS WELL AS REVERSAL OF HEPARIN WITH PROTAMINE. PT CONTINUED TO REQUIRE DOPAMINE FOR HYPOTENSION.
PT HAD CATHETER PLACED DURING PROCEDURE, THE END SHEDDED AND PIECES LODGED IN CHEST. PT HAD TO HAVE ADD'L SURGERY TO REMOVE THE FOREIGN BODY, NOTHING FOUND.
ON 5/9/96, CATHETER WAS IMPLANTED SUBCUTANEOUSLY WITH DOUBLE LUMEN PORT. ON 5/13/96, CHEST X-RAY PRIOR TO INITIATION OF CHEMOTHERAPY REVEALED CATHETER HAD MIGRATED FROM PORT TO THE RIGHT ATRIUM NECESSITATING AN ADD'L PROCEDURE TO REMOVE CATHETER.
A FIBEROPTIC BRONCHOSCOPE WAS BEING PERFORMED ON AN OUT-PATIENT. THE PULMONOLOGIST TOOK THREE BIOPSIES WITH A CO'S DISPOSABLE PULMONARY ALLIGATOR BIOPSY FORCEP UNDER THE DIRECTION OF FLUOROSOCPY. THREE BIOPSIES WERE SUCCESSFULLY OBTAINED. A FOURTH SPECIMEN WAS NEEDED AND THE BIOPSY FORCEPS WAS INSERTED INTO THE SCOPE, FORCEP OPENED, CLOSED AND DURING THE PROCESS OF REMOVING THE FORCEPS, THE PHYSICIAN AND RADIOLOGY TECH NOTICED THE BIOPSY CUP FROM THE FORCEPS REMAINED IN THE PT. THE DISTAL CUP FROM ONE SIDE OF THE FORCEPS WAS MISSING. THE PROCEDURE WAS DISCONTINUED, THE PT WAS ADMITTED FOR OBSERVATION AND ADD'L TESTS; INCLUDING A CT SCAN AND ANTIBIOTIC THERAPY. PT DISCHARGED 10-14 DAYS OF ADD'L ANTIBIOTIC THERAPY AND WILL BE REEVALUATED IN 14 DAYS.
PT WITH UNSTABLE ANGINA WENT FOR L-HEART CATH & CINEARTERIOGRAMS. AT CONCLUSION OF PROCEDURE PORTION OF GUIDE WIRE INTRODUCER FRACTURED DURING REMOVAL - REMAINING IN THE PT. CAUSED PERFORATION OF R-DEEP FEMORAL ARTERY AND HYPOTENSION REQUIRING TREATMENT WITH PLASMANATE AND A RADIOLOGIC CONSULT. LARGE HEMATOMA IN PROFUNDA ARTERY AND 3 INTROUDCER FRAGMENTS WERE NOTED AND SUBSEQUENTLY REMOVED SURGICALLY.
THE UNIT SPARKED WHEN TURNED ON. THE PT CONTINUED TO USE IT AND REPORTED THAT IT RAN ROUGH DURING USE. THE UNIT SPARKED AGAIN WHEN IT WAS TURNED OFF. NO PT INJURY OCCURRED.
EXCESSIVE FLEXION LED TO HIGH STRESS UPON THE PEG OF THE STABILIZER INSERT. STABILIZER PEG PORTION OF POLYETHYLENE INSERT SHEARED OFF.
ANESTHESIA TECH REPORTED DURING A CASE IT WAS OBSERVED TO BE LOSING BAG PRESSURE. IT WAS OBSERVED THAT A CIRCUIT CONNECTION HAD SEPARATED. UPON TRYING TO FIX CONNECTION, IT WAS OBSERVED THE CIRCUIT WAS BROKEN. THE PT WAS "BAGGED" WHILE ANOTHER CIRCUIT WAS OBTAINED AND THE CIRCUIT WAS REPLACED. NO HARM REPORTED TO PT.
NURSE REPORTED THAT 5-10 MIN INTO HEMODIALYSIS TREATMENT THE BLOOD LEAK ALARM ON THE MACHINE WENT OFF. THE DIALYSATE TESTED POSITIVE FOR A BLOOD LEAK. EBL >100CC. TREATMENT WAS DISCONTINUED.
THE TIP OF THE DRAIN WAS NOTED TO BE MISSING WHEN THE DRAIN WAS REMOVED POST-OPERATIVELY. ADD'L ABDOMINAL SURGERY WAS REQUIRED TO REMOVE THE TIP OF THE DRAIN.
FAILED RIGHT TOTAL HIP ARTHROPLASTY, DISASSEMBLY OF THE ACETABULAR LINER. PARTS REPLACED IN ADDITION TO LINER.
CUP SHIFTED SOME TIME AGO TO LESS THAN OPTIMAL POSITION. CUP STABILIZED WITH FIBROUS INGROWTH. PT PRESENTED WITH PAIN DUE TO HEAD WEARING AWAY PLASTIC EDGE OF CUP DUE TO MALALIGNMENT. CUP WAS REMOVED. CLUSTER CUP WITH ONE SCREW WAS IMPLANTED.
EXCESSIVE STRESS ON PATELLA AND TIBIAL SURFACES LED TO DELAMINATION. REPLACED PATELLA AND TIBIAL INSERT.
HIGH STRESS TO TIBIAL POLY LED TO DELAMINATION, LACK OF INGROWTH TO TIBIA. METAL ON METAL WEAR BETWEEN THE TIBIA AND FEMUR. COMPLETE WEAR THROUGH OF TIBIAL POLY, LOOSE TIBIAL BASEPLATE, SCRATCHING OF FEMORAL COMPONENT. REPLACED ENTIRE PRODUCT WITH ANOTHER BRAND, STABILIZED KNEE, PATELLA WAS LEFT AS IS IN THE PT.
LEADS WERE CAPPED ON 5/30/96 DUE TO NOISE AND MULTIPLE SHOCKS AND ABORTS. THERE WAS NO INDICATION THAT THE GENERATOR WAS NOT PERFORMING TO SPEC.
WHILE PERFORMING A TOTAL HIP PROCEDURE THE SURGEON PREPARED THE FEMUR TO ACCEPT A SIZE 9 COMPONENT, THE BONE CEMENT WAS MIXED FOR 90 SECS AND INSERTED INTO A CEMENT GUN CARTRIDGE, THE SURGEON NOTED THAT THE CEMENT WAS STILL VERY RUNNY AT APPROX 7 MINS, THE STEM WAS INSERTED BUT COULD ONLY SEATED 50% INTO THE CANAL, THE CEMENT WAS HARD AT 8 MINS. THE STEM HAD TO BE REMOVED, THE CEMENT COULD NOT BE REMOVED SO A SIZE 6 COMPONENT WAS USED.
PT'S PARENTS CLAIM DEVICE UNDERINFUSED, CAUSING SEIZURES AND BRAIN DAMAGE DUE TO DEHYDRATION. DEVICE RETAINED BY PARENTS' LAWYERS FOR INDEPENDENT TESTING.
AN INCIDENT OCCURRED WHILE PERFORMING A LEFT HEART CATHETERIZATION. THE WIRE WAS ADVANCED THROUGH AN ENTRY NEEDLE THROUGH VERY TORTUOUS ANATOMY. THE WIRE WAS PULLED BACK THROUGH AN ENTRY NEEDLE TO REPOSITION IT WHEN THE COATING SHEARED AND PIECES DETACHED IN THE PT. ALL PIECES WERE SUCCESSFULLY RETRIEVED. THE PT EXPERIENCED NO SEQUELAE AS A RESULT OF THIS EVENT. NO PT INFO WAS AVAILABLE DUE TO PT CONFIDENTIALITY.
PT WITH UNSTABLE ANGINA WENT FOR L-HEART CATHETER AND CINEARTERIOGRAMS. AT CONCLUSION OF PROCEDURE PORTION OF WIRE INTRODUCER FRACTURED DURING REMOVAL, REMAINING IN THE PT. CAUSED PERFORATION OF R-DEEP FEMORAL ARTERY AND HYPOTENSION REQUIRING TREATMENT WITH PLASMANATE AND A RADIOLOGIC CONSULT. LARGE HEMATOMA IN PROFUNDA ARTERY AND 3-WIRE INTRODUCER FRAGMENTS WERE NOTED AND SUBSEQUENTLY REMOVED SURGICALLY.
DURING A LAPAROSOCPY PROCEDURE, THE HIGH FREQUENCY CORD CAME OFF AND BURNED THE CORNER OF THE PT'S LIP. ACCORDING TO USER, THERE WAS NOTHING WRONG WITH THE CORD, BUT IT WAS NOT PLUGGED IN PROPERLY.
ONE OF CO'S CUSTOMERS HAD TWO EVENTS IN WHICH THE RESERVOIR FOR THE RESUSCITATOR DID NOT INFLATE DURING USE. ONE EVENT OCCURRED ON 5/11/96 THE OTHER 5/13/96. THE FLOW TO THE DEVICES WERE FROM 15 TO 25 LPM PER "E" TANKS WHICH HAD GREATER THAN 500 PSI. THE CUSTOMER DESCRIBES ONE EVENT ATTEMPTING TO PROVIDE "REGULAR" VENTILATION AND THE OTHER HYPERVENTILATION. THE RESERVOIR IS DESCRIBED AS COLLAPSING UPON ITSELF WITH EACH EVENT. ONE UNIT WAS TESTED AFTER THE EVENT ON A TANK WITH 2000 PSI AND IS SAID TO HAVE EXHIBITED THE SAME BEHAVIOR. THIS BAG IS BEING RETURNED FOR EVALUATION. THE RESERVOIRS HAD TO BE REMOVED AND THE PTS WERE VENTILATED WITH AMBIENT AIR IN EACH EVENT. THE PT FROM THE EVENT ON 5/11/96 EXPIRED. THE CUSTOMER FELT THE PT'S ARREST STATUS WAS CONTRIBUTORY TO THE DEATH AND NOT A RESULT OF THEIR INABILITY TO DELIVER 02 TO THE PT VIA THE RESUSCITATOR.
PER CUSTOMER, BAGS ARE NOT DRAINING. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC SEPARATED FROM THE METAL.
EXCESSIVE WEAR LEADING TO DELAMINATION OF THE TIBIAL POLY. DELAMINATION OF PATELLA POLY DUE TO EXCESSIVE WEAR. REPLACED LG X 7MM TIBIAL INSERT DUE TO COMPLETE WEAR THROUGH. REPLACED WORN METAL BACKED PATELLA.
REMOVED PATELLA, DID NOT REPLACE. REMOVED LOOSE TIBIAL TRAY AND REPLACED. TIBIAL INSERT WAS COMPLETELY WORN THROUGH. DEGENERATION OF PATELLA BONE STOCK. DELAMINATION OF TIBIAL POLY WITH LACK OF INGROWTH TO THE TIBIAL BASEPLATE.
NURSE REMOVED TWO CO TUBES FROM PT, NOTICED THAT ONE TUBE HAD A JAGGED END. PHYSICIAN WAS NOTIFIED AND 1/4" TO 1/2" TIP WAS REMOVED FROM PT ON 4/30/96.
BONE SCAN BY DR SHOWED LOOSENING OF TIBIAL PLATE. REVISION SURGERY PERFORMED BY DR ON 5/1/96. TIBIAL PLATE WAS FOUND TO BE FRACTURED.
THIS PULSE GENERATOR WORKED PERFECTLY FOR 16 MONTHS, THEN "NO OUTPUT" WAS OBSERVED ON THE VENTRICULAR CHANNEL. THIS WAS CONFIRMED IN EVERY PROGRAMMED MODE, DDI, DDD AND VVI AS WELL AS IN THE ASYNCHRONOUS MODE. AN IMPEDANCE GREATER THAN 3 OHMS WITH EITHER BIPOLAR OR UNIPOLAR CONFIGURATION WAS MEASURED BY TELEMETRY ON THE VENTRICULAR LEAD AND IT WAS NECESSARY TO EXPLANT THE PULSE GENERATOR. THE THRESHOLDS MEASURED DURING THE SURGICAL PROCEDURE CONFIRMED THAT THE LEAD WAS IN GOOD CONDITION. THE MFR'S LAB APPRAISAL DID NOT FIND ANY DEFECT IN THE DEVICE, ESPECIALLY IN THE CONNECTOR. THE ONLY OBSERVATIONS THAT COULD BE MADE WOULD CONCERN THE PRESENCE OF BLOOD INSIDE THE VENTRICULAR CHANNEL. THIS COULD BE ENOUGH TO EXPLAIN THE LOSS OF STIMULATION. THE BLOOD MAY HAVE DIVERTED A PART OF THE ENERGY DELIVERED AT THE MOMENT OF STIMULATION. THIS ASSUMPTION SEEMS TO BE CONFIRMED BY THE PRESENCE OF LOW AMPLITUDE AND INEFFECTIVE STIMULI, WHICH IS VISIBLE ON THE ECG RECORDING RETURNED WITH THE DEVICE.
NO OUTPUT. LAB MANUF: SHORT CIRCUIT IN THE CIRCUIT.
NO OUTPUT. LAB MANUF: PREMATURE BATTERY DEPLETION DUE TO LEAKAGE CURRENT IN THE INTEGRATED CIRCUIT.
NO OUTPUT. LAB MANUF: PREMATURE BATTERY DEPLETION.
NO OUTPUT OF THE VENTRICULAR CHANNEL. LAB  MANUF: COMPONENT DEFECT OF THE VENTRICULAR CIRCUIT.
PAROXYSMAL BRADYCARDIA. CONNECTIONS A AND V OVERFLOWED. WATERPROOF DEFECT OF THE PLASTIC SCREW PROTECTOR. LAB: THAT PACEMAKER WAS PROGRAMMED WITH AN OUTPUT AT 6V AND TELEMETRY HAS CONFIRMED THE EOL. BATTERY IMPEDANCE: 37 KOHMS.
LAB: OK IN VVI MODE. TELEMETRY: BACK UP MODE CODE C. PROBABLY EXPOSED TO ELECTRO-MAGNETIC INTERFERENCES.
WHILE ATTEMPTING TO PLACE A TROCAR DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE THE LEFT ILIAC ARTERY AND VEIN OF THE PT WERE PARTIALLY TRANSECTED. AS DESCRIBED BY HOSP PERSONNEL, THE SURGEON WAS UNSUCCESSFUL IN ENTERING THE PERITONEAL SPACE ON HER FIRST ATTEMPT WITH THE TROCAR. A SECOND ATTEMPT WAS THEN MADE THROUGH THE SAME INCISION. IT IS BELIEVED THAT THE VESSELS BECAME DAMAGED DURING THE SECOND ATTEMPT. A VASCULAR SURGEON WAS BROUGHT INTO THE SURGERY AND PERFORMED A GRAFT OF BOTH VESSELS. THE PT LEFT THE OR WITH NO PULSE IN HER LOWER LEG AND WAS BROUGHT BACK INTO SURGERY LATER THE SAME NIGHT TO REMOVE A BLOOD CLOT. THE PT HAS SINCE BEEN REPORTED TO HAVE REGAINED HER PULSE AND IS IMPROVING. THE HOSP HAS REFUSED TO RETURN THE TROCAR INVOLVED IN THIS INCIDENT. HOWEVER, LOCAL SALES REP WAS PERMITTED TO EXAMINE THE TROCAR AND CONCLUDED THAT THE DEVICE WAS IN PROPER WORKING ORDER. ADDITIONALLY, THE ASSISTING TECH REPORTED TO SALES REP THAT HE DID NOT FEEL THAT THE DEVICE WAS AT FAULT.
CEMENT SET UP TOO FAST AND CAUSED SURGERY TO BE PROLONGED APPROX 2 HRS BECAUSE THE DR HAD TO REMOVE THE CEMENT THAT HAD SET UP IN THE CANAL.
BAGS ARE NOT DRAINING AND URINE IS BACKING UP INTO PT'S BLADDER. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT.
DUE TO THE DELAMINATION OF THE PATELLA, THE PATELLA WAS REPLACED ALONG WITH THE ARTICULATING SURFACE, TIBIA, AND FEMUR.
DURING A BLADDER STONE REMOVAL PROCEDURE, WHILE GRASPING A LARGE STONE, THE LITHOTRITE JAWS BECAME MIS-ALIGNED. CYSTOTOMY WAS PERFORMED TO REMOVE THE STONE AND THE INSTRUMENT.
DURING A LAPAROSCOPIC "NISSEN" ANTIREFLUX PROCEDURE, PT HAD PULMONARY EMBOLISM AND EXPIRED.
ONE DAY AFTER THE PT UNDERWENT A THREE HR PROCEDURE DURING WHICH THE DEVICE WAS USED, THE PT COMPLAINED OF DIFFICULTY SPEAKING AND WAS COUGHING UP "MATERIAL." THE PT WAS REFERRED TO THE ER WHERE STEROIDS AND ANTIBIOTICS WERE ADMINISTERED. THE PT OUTCOME IS NOT KNOWN AT THIS TIME. SUBSEQUENT CONTACT WITH THE OR SUPV DETERMINED THAT AT THE TIME OF THE EVENT, THE DEVICES WERE BEING CLEANED WITH AMERSE, A PHENOL BASED SOAP, CONTRARY TO THE PRODUCT LABELLING. THE SITE REPORTED THEY DISCONTINUED USE OF THIS PRODUCT AFTER A CO'S REP NOTIFIED THEM THAT THE LABELLING WARNING AGAINST USE OF SUCH CLEANING AGENTS.
AIRWAY PRESSURE MONITOR WAS REPORTED TO HAVE FAILED TO EXHIBIT LOW PRESSURE ALARM CONDITION WHEN PT CIRCUIT BECOME DISLODGED FROM THE TRACHEAL TUBE. AN ATTENDING THERAPIST RE-CONNECTED BREATHING CIRCUIT WITHOUT ANY FURTHER INCIDENT. DEVICE WAS NOT PROPERLY SET UP PRIOR TO OPERATION. UNIT WAS SUBSEQUENTLY SET UP ACCORDING TO MFR'S SPECS.
CO RECEIVED ALLEGATION THAT A REGULATOR WAS INVOLVED IN A HOUSE FIRE. A CIGARETTE HAD BEEN LEFT BURNING UNATTENDED IN THE PLAINTIFF'S HOME. THE CLAIM ALLEGES THAT THE REGULATOR/CYLINDER WAS LEAKING OXYGEN. IT HAS BEEN ALLEGED THAT THE PLAINTIFF WAS INJURED TRAUMATICALLY AND EMOTIONALLY AND HAS EXPERIENCED SERIOUS DIFFICULTY IN LEARNING TO SPEAK AND COMMUNICATE AS A RESULT OF THE FIRE. IT HAS ALSO BEEN ALLEGED THAT THREE OTHER PLAINTIFFS IN THE HOUSE WERE INJURED AS A RESULT OF THE FIRE.
7/2 9:00 AM, DURING AM MEDICAL ROUNDS VENTILATOR ALARM WAS SOUNDING. PT BEING ON ISOLATION, GOWN, GLOVES AND MASK WAS MANDATORY BEFORE ENTERING ROOM. THE VENTILATOR WAS FOUND IN AN IN-OPERATIVE MODE PROVIDING NO VENTILATORY SUPPORT WITH PT IN DISTRESS. BAG WAS UTILIZED AND VENTILATOR WAS CHANGED. MD NOTIFIED, PT ASSESSED, NO INTERVENTION NEEDED, PT CONDITION UNCHANGED AFTER EVENT.
RPTR CLAIMS THAT SHE HAS HAD HER IMPLANTS REPLACED 4 TIMES, AND HAS HAD 3 BREAST SURGERIES BEGINNING WITH THE FIRST IMPLANT SURGERY. SHE CURRENTLY DOES NOT HAVE IMPLANTS IN NOW, DOES NOT KNOW IF CALCIUM DEPOSITS OCCURRED, AND HAS HAD BIOPSIES DONE ON THE TISSUE SAMPLES THAT WERE EXAMINED PATHOLOGICALLY. INITIAL IMPLANTS WERE PLACED FOLLOWING MASTECTOMY FOR CANCER. MEDICAL PROFESSIONALS HAVE CONFIRMED SILICONE OUTSIDE THE BREAST SCAR TISSUE CAPSULE; A BIOPSY OF LEFT DELTOID WAS POSITIVE. RPTR STATES THAT HER EXPLANTATED DEVICES ARE "WITH AN ATTY IN SAFE". RPTR CLAIMS TO HAVE HAD INFECTION, HEMATOMA, EXCESS FLUID AND NUMBNESS BILATERALLY AT THE SURGICAL SITES. RPTR CLAIMS TO HAVE HAD 2 CAPSULAR CONTRACTURES. RPTR CLAIMS TO HAVE BEEN DIAGNOSED WITH THE FOLLOWING AFTER IMPLANTATION: MOTOR NEURON DISEASE, ELEVATED CHOLESTEROL, EYES EASILY FATIGUE, FREQUENT MIGRAINES/SEVERE HEADACHES, CONNECTIVE TISSUE DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, NUMEROUS MOLES, FRECKLES, ETC, AND CHRONIC FATIGUE SYNDROME.
AT 8 AM PT FOUND WITH BROKEN TRACHEOSTOMY - OUTER CANNULA AT POINT WHERE TRACH CONNECTS TO VENTILATOR HOSE. TRACH ALSO NOTED TO HAVE CUFF LEAK. PT C/O SOB. PT TRANSPORTED TO ED FOR TRACHEOSTOMY REPLACEMENT. CHEST X-RAY 3/22/96. REPORT "LUNGS CLEAR OF FOREIGN MATTER." MFR RECOMMENDS 29 DAYS WITHOUT IMPLANT.
OZONE REACTS DIRECTLY WITH RUBBER TO FORM AN OZONIDE OF THE BASIC RUBBER HYDROCARBON, YIELDING A WHITISH BLUSH ON THE SURFACE KNOWN AS FROST 5-6. FINALLY, THESE ANTIDEGRADANTS ARE NOT A CURE-ALL FOR POLYMER AGE RESISTANCE PROBLEMS, THEY MERELY EXTEND THE SERVICEABLE LIFE OF THE COMPOUND. WITHIN HTE PRACTICAL LIMITATIONS OF RUBBER COMPOUNDING, IT IS FOR INSTANCE NOT POSSIBLE TO GIVE HIGHLY UNSATURATED NATURAL RUBBER THE SAME OZONE RESISTANCE AS IT INHERENT IN TOTALLY SATURATED ETHYLENE-PROPYLENE RUBBER.
PT HAD EPICARDIAL PACING WIRES CONNECTED TO EXTERNAL PACEMAKER GENERATOR. THE PT WAS BEING MONITORED VIA CO ARRHYTHMIA MONITORING SYSTEM. AT APPROX 0425 THE NURSE OBSERVED THE PT TO DEMONSTRATE A CHANGE IN RHYTHM. THE ARRHYTHMIA MONITORING SYSTEM PROVIDED NO AUDIBLE ALARM BASED ON THE RHYTHM CHANGE. ASSESSMENT OF THE PT REVEALED A STATE OF CARDIAC ARREST. REVIEW OF THE MONITORED RHYTHM DEMONSTRATED PACEMAKER SPIKES WITHOUT ANY CAPTURE (QRS). ARRHYTHMIA MONITORING SYSTEM DID NOT IDENTIFY THE RHYTHM CHANGE AS "PACE NOT CAPTURE" OR "ASYSTOLE" WHICH WOULD HAVE PROVIDED AUDIBLE ALARM.
THE PT WAS BROUGHT TO THE CATH LAB FOR AN INTERVENTIONAL PROCEDURE ON 5/29/96. THE PROCEDURE TO BE PERFORMED WAS ROTATIONAL ATHERECTOMY. THE ARTERY TO BE REPAIRED WAS THE POSTEROLATERAL. THE PROCEDURE STARTED BY INSERTING A GUIDING CATHETER INTO THE ARTERY AND POSITONING IT SO THAT THE END FIT INTO THE CORONARY ARTERY. THIS WAS ACCOMPLISHED WITHOUT MUCH DIFFICULTY. THE ROTATIONAL DEVICE THAT HAS A FELXIBLE GUIDE WIRE IN THE CENTER OF IT WAS THEN INSERTED INTO THE GUIDING CATHETER AND ADVANCED TO THE TIP OF THE GUIDING CATHETER. THE WIRE IS ADVANCED INTO THE CORONARY ARTERY ACROSS THE LESION AND THEN THE TIP OF THE ROTATIONAL DEVICE, CALLED A BURR, IS SUPPOSED TO TRACK OVER THE WIRE. IN THIS CASE, THE BURR WAS "FROZEN" IN PLACE IN THE TIP OF THE GUIDE. IN ORDER TO FREE UP THE DEVICE, IT WAS DECIDED TO SPIN THE BURR AT A LOW RPM AND TRY TO "BURP" IT FORWARD. THIS WAS ATTEMPTED HOWEVER THE PT DEVELOPED CHEST PAIN AS WELL AS A VERY SIGNIFICANT DROP IN BLOOD PRESSURE. ANGIOGRAPHY REVEALED NO FLOW IN THE LEFT CORONARY ARTERY. STENTING IN THE LEFT MAIN ARTERY AND THE DIAGONAL ARTERY WAS ACCOMPLISHED, HOWEVER THE PT DID NOT RESPOND. CPR WAS INITIATED AND CONTINUED FOR 45 MIN WITHOUT SUCCESS. THE CPR WAS DISCONTINUED AND THE PT WAS PRONOUNCED DEAD.
THE PT IS A 54-YR-OLD MALE WHO, SOME 12 YEARS AGO, HAD A SEVERELY DISPLACED COMMINUTED CENTRAL FRACTURE DISLOCATION OF HIS LEFT HIP. AT THAT TIME HE HAD OPEN REDUCTION AND INTERNAL FIXATION OF HIS ACETABULUM. HE GENERALLY HAS DONE REASONABLY WELL. HE IS KNOWN TO HAVE A COPIOUS AMOUNT OF ECTOPIC BONE AND HAS A GREAT DEAL OF STIFFNESS WITH INTERMITTENT PAIN IN HIS HIPS. SOME TWO TO THREE WEEKS AGO HE BEGAN TO HAVE INCREASED SHARP TYPE PAIN WHICH WAS QUITE DIFFERENT THAN HIS PREVIOUS PAIN. X-RAY SHOWS A PORTION OF A DRILL BIT WHICH HAD BEEN BROKEN OFF AND EMBEDDED IN BONE WHICH APPEARS TO BE IN HIS JOINT.
PT WAS USING FOLDING WALKER ON 6/11/96 IN THE EVENING. THE WALKER BROKE AT A WELDED JOINT. PT FELL AND HAD PAIN IN THE RIGHT UE. FAMILY TOOK THE PT TO THE ER ON 6/13/96. PT WAS FEELING BETTER SO THE PT WAS NOT TAKEN IMMEDIATELY. PT WAS DIAGNOSED AS HAVING A FRACTURED PELVIS AND WAS TO BE RELEASED ON 6/14/96. PT HAD AN UNSCHEDULED (AND UNRELATED FALL) SURGERY. PT HAS A PRIMARY DIAGNOSIS OF METASTATIC CANCER. THIS INFO WAS REPORTED BY RPTR'S HOME HEALTH AID AS REPORTED BY FAMILY.
PT WAS SEIZURING AND INTUBATED PER ANESTHESIA. PT PLACED ON VENTILATOR AND RECEIVED 2 BREATHS WHEN PT APPEARED TO BE FIGHTING THE VENTILATOR. PT WAS TAKEN OFF THE VENT AND MANUALLY VENTILATED. UPON INSPECTION OF THE VENT CIRCUIT (SWIVEL ADAPTOR), A SMALL PIECE OF PLASTIC WAS FOUND PARTIALLY OBSTRUCTING THE CIRCUIT.
BREASTS BECAME ASYMETRICAL, ONE WAS HARD, DEFORMED. NO PAIN. UNDERWENT BILATERAL REPLACEMENT OF BREAST IMPLANTS, CAPSULECTOMY. BOTH IMPLANTS HAD RUPTURED.
PT'S ECG AND HEART RATE WERE BEING MONITORED BY THE DEVICE. THE LOW HEART RATE ALARM LIMIT WAS SET TO 90 BPM AND THE ALARM WAS BELIEVED TO BE IN THE ACTIVE MODE. PT WAS ALSO CONNECTED TO A SEPARATE PULSE OXIMETER. THE NURSE WAS ALERTED BY THE PULSE OXIMETER ALARM AND FOUND THE PT'S SAO2 TO BE BETWEEN 70 AND 80%. THE CO MONITOR WAS NOT ALARMING AT ALL AND THE DISPLAYED HEART RATE WAS BETWEEN 60 AND 70 BPM AND PT WAS DUSKY. ALSO THE BUILT-IN RECORDER DID NOT RUN AND RECORD THE EVENT.
PT HAD DEFLATION OF HER LEFT BREAST PROSTHESIS THAT OCCURRED OVER A PERIOD OF TIME. NO SPECIFIC INCIDENT IN HER HISTORY TO ACCOUNT FOR THE SPONTANEOUS RUPTURE OF THE IMPLANT.
LIPIDS ORDERED 6.25ML TO INFUSE OVER 10 HRS. PUMP PROGRAMMED TO DELIVER .6 CC/HR. THE INFUSION WAS STARTED AT 1310. THE PUMP ALARMED AT 1700 AND SYRINGE HAD 1 CC REMAINING. VOLUME OF 6.25 CC WAS DELIVERED OVER 4 HRS INSTEAD OF 10 HRS.
A 41-YR-OLD FEMALE PT HAD A PORT SURGICALLY IMPLANTED 4/18/96 TO FACILITATE CHEMOTHERAPY. SHE RETURNED ON 6/5/96 FOR EVALUATION OF THE CATHETER WHICH WAS NON-FUNCTIONING, AND SUSPECTED TO BE THROMBOSED. A VENOGRAM STUDY SHOWED THE CATHETER WAS SHEARED OFF APPROX 4 CM FROM THE HUB. THE DISTAL SEGMENT WAS LOCATED IN SUPERIOR VENA CAVA, EXTENDING INTO THE RIGHT ATRIUM. IT WAS RETRIEVED PERCUTANEOUSLY VIA THE RIGHT FEMORAL VEIN WITH CT GUIDANCE.
RESIDENT TRANSFERRED TO ACUTE-CARE HOSP ER AFTER ATTEMPTS BY PROFESSIONAL NURSING STAFF TO DEFLATE BALLOON OF FOLEY CATHETER FOR REMOVAL FAILED. ATTEMPTS BY ER MEDICAL PERSONNEL ALSO WERE UNSUCCESSFUL AND RESIDENT WAS SENT TO OR WHERE RESIDENT WAS GIVEN IV ANALGESIA AND CONTRAST WAS USED TO VISUALIZE BALLOON IN BLADDER. A SMALL NEEDLE WAS THEN INSERTED AND BALLOON DEFLATED AND CATHETER REMOVED. BLADDER CONTAINED A LARGE AMOUNT OF CALCULI, A UTI WAS PRESENT, AND RESIDENT HAD A 1-2+ BENIGN PROSTATIC HYPERTROPHY. RESIDENT WAS TREATED BY PERFORMING A CYSTO W/CYSTOLITHOTRIPSY. RESIDENT WAS ADMITTED FOR A 23 HR OBSERVATION PERIOD AND TREATMENT FOR THE UTI.PRINICPAL DX: RETAINED, PLUGGED FOLEY, SECONDARY DX: BLADDER CALCULI UTI. PRINCIPAL PROCEDURE: REMOVAL OF RETAINED FOLEY AND CYSTO W/CYSTOLITHOTRIPSY.
BREAST IMPLANT WAS REMOVED FROM RIGHT BREAST. PT NOTED BY DR TO HAVE SILICONE GEL IN BREAST CAPSULE PRIOR TO REMOVING IMPLANT.
DEVICE WAS USED TO CUT AND SEAL VAGINAL CUFF FOLLOWING ABDOMINAL HYSTERECTOMY. THREE HRS POST-SURGERY, BLEEDING NOTED. RETURNED TO SURGERY TWO HRS AFTER NOTED BLEEDING. EXTREME RIGHT END OF VAGINAL CUFF NOTED TO BE OPEN APPROX 1CM; UPON VAGINAL EXAM UNDER ANESTHESIA. SUTURED CLOSED.
PT TO SURGERY FOR FAILED HARDWARE RELATED TO IMPLANTED MORPHINE PUMP.
DR EXPLANTED BILATERAL BREAST PROSTHESIS DUE TO LEFT BREAST ABCESS. PROSTHESES WERE NOT RUPTURED UPON EXAMINATION.
LEFT CAPSULOTOMY AND REPLACEMENT OF IMPLANT. CAPSULAR CONTRACTION NOTED. SALINE IMPLANT WAS PLACED.
RIGHT CAPSULOTOMY AND REPLACEMENT OF IMPLANT. HARDENED TISSUE NOTED IN UPPER OUTER QUADRANT OF THE RIGHT CAPSULAR CONTRACTION NOTED. SALINE IMPLANT PLACED. PT HAD COMPLAINTS OF SORENESS SCAR TISSUE NOTED.
PT HAS CENTRAL CATHETER. DURING LASERDIODE PROCEDURE, ANESTHETIC ADMINISTERED VIA IV TUBING NOTED THAT UNABLE TO SEDATE NEONATE. UPON EVALUATION OF SITUATION, NOTED THAT LEAKAGE FOUND AT BI-FUSE THUS PT DID NOT RECEIVE MEDICATION. LINE VIOLATION AND LACK OF SEDATION OCCURRED. IV TUBING SET UP CHANGED AND SEDATION GIVEN. SIGNIFICANT DELAY IN PROCEDURE DUE TO EQUIPMENT FAILURE. PT GIVEN CLAFORAN AND VANCOMYCIN X 1 DOSE DUE TO CENTRAL LINE VIOLATION AND POTENTIAL FOR BACTEREMIA. NEONATE WITH UMBILICAL CENTRAL VENOUS CATHETER WAS ON A VASOPRESSOR (DOPAMINE). NOTED THAT CHILD HAD FLUID LEAKAGE FROM TUBING, AND BIFUSE NOTED TO BE LEAKING AT THE CONNECTION. ALL IV TUBING CHANGED, VASOPRESSOR CONTINUED. CENTRAL VENOUS CATHETER LINE VIOLATION RESULTING WITH POTENTIAL FOR BACTEREMIA, ALSO POTENTIAL FOR DECREASE IN BLOOD PRESSURE DUE TO LEAKAGE AND THIS CHILD WAS VERY UNSTABLE AT THE TIME OF THIS INCIDENT.
PT WAS AUGMENTED IN 11/82 USING DOUBLE-LUMEN IMPLANTS. THE PT HAD PAIN SOON AFTER SURGERY IN BOTH BREASTS AS WELL AS ENCAPSULATION. SHE THEN DEVELOPED ASTHMA FOLLOWED BY ARTHRALIGAS, MEMORY PROBLEMS, WEAKNESS, AND FATIGUE. ON PHYSICAL EXAMINATION, SHE HAS SEVERE CAPSULAR CONTRACTURE OF BOTH BREASTS. ULTRASOUND EXAMINATION DEMONSTRATED BILATERAL RUPTURED IMPLANT WITH SILICONE GRANULOMA FORMATION AT 10:00 O'CLOCK ON THE LEFT SIDE; AND POSSIBLE SILICONE GRANULOMA FORMATION AT 7:00 O'CLOCK ON THE LEFT SIDE; AND SYSTEMIC SYMPTOMS, PAIN, AND CONTRACTURE AS WELL AS BILATERALLY RUPTURED IMPLANTS, IT IS MEDICALLY NECESSARY TO REMOVE BOTH IMPLANTS.
THE PT IS A 47-YR-OLD WOMAN WHO HAD A HISTORY OF HODGKINS'S DISEASE IN 1969 AND PRE-CANCEROUS LESIONS IN THE BREAST. SHE HAD A BILATERAL SUBCUTANEOUS MASTECTOMY IN 2/96. AT THAT TIME SHE WAS RECONSTRUCTED WITH ANOTHER CO'S SUBMUSCULAR IMPLANTS. BECAUSE OF CAPSULAR CONTRACTURE, BOTH IMPLANTS WERE REPLACED IN 12/87 USING CO'S 270CC IMPLANTS. THE PT THEN DEVELOPED DRY EYES, FREQUENT BRONCHITIS, CHRONIC FATIGUE, ASTHMA, SHORTNESS OF BREATH AND BREAST PAIN FROM THE RIGHT AXILLA TO THE RIGHT NIPPLE AREA. SHE HAS RE-DEVELOPED CONTRACTURE ON BOTH SIDES AND FEELS SIGNIFICANT DISCOMFORT FROM THE IMPLANTS.
THE PT IS A 26-YR-OLD WOMAN WITH BILATERAL AUGMENTATION USING THE SALINE IMPLANTS IN 1990. SINCE 1990, SHE NOTED PROBLEMS WITH RECURRENT INFECTIONS, SUCH AS BLADDER INFECTION, SINUS INFECTION. SHE HAS PAINS AT THE BOTTOM OF THE FEET, WEAK AND SORE WRISTS. PHYSICAL EXAMINATION DEMONSTRATES A CLASS I CONTRACTURE OF THE BREASTS AND THE SALINE IMPLANT APPEARS TO BE INTACT. BECAUSE THE CAPSULE CONTAIN SILICONE AND INFLAMMATORY CHANGES, IT WOULD BE MEDICALLY NECESSARY TO REMOVE THE CAPSULE IN THE PT SUSPECTED OF HYRPERSENSITIVITY REACTION TO THE IMPLANT.
THE PT IS A 43-YR-OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST IMPLANTATION IN 8/87 USING CO'S 200CC GEL-FILLED BREAST IMPLANTS. THE PT HAS VERY MILD SYSTEMIC SYMPTOMS OF FATIGUE, URINARY TRACT INFECTIONS, SOME SHORT-TERM MEMORY LOSS AND MYALGIA IN THE MID-BACK AREA AND MILD DISCOMFORT IN THE BREAST. HOWEVER, ON ULTRASOUND AND XEROMAMMOGRAM EXAMINATION, SHE HAS HEAVY CALCIFICATION OF THE LEFT BREAST AND A HIGHLY SUSPICIOUS RUPTURE. BECAUSE OF THE HIGHLY SUSPICIOUS RUPTURE ON THE LEFT SIDE AND THE OLD AGE OF THE IMPLANTS, IT WILL BE MEDICALLY PRUDENT TO REPLACE THESE IMPLANTS AND TO DO A TOTAL CAPSULECTOMY BECAUSE OF THE ENCAPSULATION ON BOTH SIDES AND THE CALCIFICAITON ON THE LEFT SIDE.
THE PULSATILE ANTI-EMBOLISM STOCKINGS THAT WERE IN USE, HAD CAUSED ABRASIONS ON THE PT'S ANTERIOR ANKLES.
THE PULSATILE ANTI-EMBOLISM STOCKINGS THAT WERE USED, HAD CAUSED ABRASIONS ON THE PT'S ANTERIOR ANKLES.
WHILE DOING A PM OF UNIT IT WAS DISCOVERED THAT WHEN THE BATTERY IS AT LOW LEVEL (BUT WITHIN RANGE OF PERFORMANCE) AND INDICATOR IS MOVED PAST THE 30 JOULE SETTING IT WILL CHARGE UP TO 30 JOULES AUTOMATICALLY WITHOUT PRESSING CHARGE BUTTON. THIS SITUATION DOES NOT HAPPEN WHEN UNIT IS PLUGGED IN WALL OUTLET OR WITH FULLY CHARGED BATTERY. WHEN THIS SITUATION OCCURS AN INADVERTENT SHOCK COULD BE DELIVERED TO PT OR OPERATOR. BIOMED TESTED THREE OF FIVE DEFIBRILLATORS AND ALL THREE HAVE THAT SAME PROBLEM.
THE PT WAS UNDERGOING AN OPEN REDUCTION, INTERNAL FIXATION OF THE LEFT HIP WITH PROSTHESIS. THE PROSTHESIS WAS INSERTED WITH THE CEMENT AND APPROX 5 MINS LATER THE PT EXPERIENCED HYPOTENSION AND SUBSEQUENT CARDIAC ARREST WHICH RESULTED IN THE PT EXPIRING. MEDICAL EXAMINER NOTIFIED AND DECLINED THE CASE.
THE PT WAS TAKEN TO SURGERY WHERE A HEMIARTHROPLASTY OF THE LEFT HIP WAS PERFORMED. THE SURGERY HAD GONE WELL WITH MINIMAL BLOOD LOSS. AS SOON AS THE GLUE WAS HARDENING, THE PT DEVELOPED A DECREASED B/P AND DECREASED HEART RATE. IN SPITE OF GOOD SUPPORT THE PT WAS TUBED AT THE TIME AND (GOOD FLOW MAINTAINED) SHE PROCEEDED TO A FULL CARDIAC ARREST, AND EXPIRED.
DURING A BIPOLAR REPLACEMENT OF THE RIGHT HIP, THE PT EXPERIENCED A COMPLETE LOSS OF BLOOD PRESSURE AND A DECREASE IN OXYGEN SATURATION TO 80%. THIS OCCURRED IMMEDIATELY AFTER THE BONE CEMENT WAS APPLIED. THE PT REQUIRED MECHANICAL VENTILATION POST OPERATIVELY AND EXPIRED 9 DAYS POST OP. SHE NEVER RECOVERED.
THERE IS A TUBE ON TOP AND BOTTOM OF THE COLUMN. THE TUBE ON THE BOTTOM GOES TO A WATER RESERVOIR, THE BOTTOM TUBE IS OBSTRUCTED, THEREFORE NO HUMIDITY IS APPLIED TO THE PT. THERE WERE SIX DEVICES AND THE CO HAS ALL OF THEM.
WHILE SHOWERING A RESIDENT THE SEAT TO THE SHOWER CHAIR BECAME LOOSE AND FELL APART. RESIDENT SUSTAINED SKIN ABRASION TO LUMBAR AREA.
PT WITH HX OF V-TACH HAS ICD. PT NEEDED PERMANENT PACER. TCP FAILED TO CONVERT PT TO NSR WITH MAX ENERGY SHOCK. FAILED TO SENSE V-FIB IMMEDIATELY POST SHOCK. THIS WAS DETERMINED DURING TESTING OF DEVICE INTERACTION. ICD WAS REPLACED 6/21/96, ORIGINALLY IMPLANTED 9/30/94.
THE DEVICES BECAME VERY HARD AND THE RPTR EXPERIENCED A LOT OF PAIN, DISCOMFORT, SEVERE FATIGUE, LACK OF SLEEP, COGNITIVE (MEMORY PROBLEMS), AND FIBROMYALGIA.
CHARCOAL LEAKS OUT OF FLANGE ON OCCASION RUINING PT'S CLOTHES.
10 FR DRAIN TUBE INSERTED DURING SURGERY ON 6/5/96. DURING BEDSIDE REMOVAL OF SAME ON 6/7/96, THE DRAIN TUBE BROKE OFF LEAVING APPROX 6 INCHES IN THE PT'S SUBCUTANEOUS TISSUES (AS CONFIRMED BY X-RAY). PT WAS RETURNED TO SURGERY FOR EXPLORATION AND REMOVAL OF THE RETAINED PORTION OF THE DRAIN TUBE.
RPTR SAID THAT SHE HAD SO MANY PROBLEMS WITH THE FIRST IMPLANTS THAT SHE DOES NOT KNOW IF THE SECOND ONE CONTRIBUTED OR ADDED ANYTHING NEW. SHE SAID THAT "A DARKNESS" APPEARED TO BE FUNGUS INSIDE THE IMPLANT. RPTR'S MAIN CONCERN IS IF SALINE IS OK. SHE IS ALSO QUESTIONING THE SAFETY OF THE PRODUCT. SHE IS BEING TREATED FOR MEMORY PROBLEMS AND FATIGUE (FROM THE FIRST IMPLANTS).
ON 3 OCCASIONS DEFIBRILLATOR-PACERS IN THE ER HAVE FAILED TO PACE. THE CAUSE WAS TRACED TO THE PACING ADAPTER WHICH HAD BENT PINS AND WOULD NOT CONNECT WITH THE DEFIBRILLATOR. IT APPEARS THE PINS ARE BENDING WHEN THE PACER CABLE IS INSERTED INTO THE DEFIBRILLATOR BUT THE CABLE WOULD LOCK IN PLACE GIVING THE APPEARANCE OF THE CABLE CONNECTING CORRECTLY. CO HAS BEEN CONTACTED ABOUT THIS PROBLEM AND THEY INDICATED THAT THIS IS A DESIGN PROBLEM WHICH THEY ARE WORKING TO IMPROVE, BUT THEY COULD NOT GIVE RPTR A TIME FRAME FOR THE NEW DESIGN.
911 CALL RECEIVED FOR A PT WITH CHEST PAIN. THE PT'S BP WAS 50/P P-218 CARDIAC MONITOR VENTRICULAR TACHYCARDIA. THE PARAMEDIC STARTED AN INTRAVENOUS SOLUTION. SEDATED THE PT IN ORDER TO PERFORM CARDIOVERSION. THE MONITOR/DEFIBRILLATOR FAILED TO CHARGE. THE SPARE BATTERY WAS INSERTED AND THE DEFIBRILLATOR DID NOT CHARGE AGAIN. THE PT WAS TAKEN CODE THREE TO THE CLOSEST EMERGENCY DEPT WHERE SHE WAS CARDIOVERTED BY THE PHYSICIAN. THE PT IS STILL IN THE HOSP AT TODAY'S DATE 7/12/96, STATUS POST CARDIAC CATHETERIZATION.
ON 7/5/95, A FIELD REP FROM THE MFR DISCOVERED AN INTERMITTENT PARTIAL OBSTRUCTION OF ONE (1) CHANNEL OF THE INSTRUMENT ASSEMBLY DUE TO A PORTION OF A SOLID PHASE PIPETTE CAP COVER. THIS IS A UNIQUE FAILURE THAT COULD NOT BE DETECTED BY STANDARD QUALITY CONTROL PROCEDURES RECOMMENDED BY THE MFR AND USUALLY PERFORMED BY THE INSTITUTION. THE END RESULT OF THE INSTRUMENT FAILURE WAS SEVENTEEN (17) POSSIBLE FALSE POSITIVE TEST RESULTS FOR CHLAMYDIA TRACHOMATIS COVERING THE TIME PERIOD FROM 5/12/96 TO 7/7/96. APPROPRIATE STEPS ARE BEING TAKEN TO NOTIFY THE PTS AND THEIR PHYSICIANS.
DEFECTIVE BRIDGE RECTIFIER. THE PT WAS SENT A REPLACEMENT SYSTEM. THE PROBLEM HAS BEEN ADDRESSED THROUGH THE USE OF A GLASS PASSIVATED, FULL WAVE BRIDGE RECTIFIER IN THE MAIN OPERATING UNIT (MOU). THIS UNIT WAS BUILT PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. NO FAILURES HAVE OCCURRED WITH THE NEW BRDIGE RECTIFIERS.
INTERMITTENT FUNCTIONING. PROBABLY CAUSED BY WORN FIBER OPTIC CABLES. NO CORRECTIVE ACTION TAKEN BECAUSE PT HAD RETURNED UNIT AT END OF TREATMENT.
A DEVICE FAILURE WAS REPORTED ON 2/10/95. A REPLACEMENT UNIT WAS SENT TO THE PT ON THE SAME DAY IN A PRIORITY OVERNIGHT SHIPMENT. UPON RETURN OF THE FAILED UNIT, VISUAL INSPECTION REVEALED THAT THE TRANSDUCER ELEMENT HAD SEPARATED FROM THE TRANSDUCER CUP. THIS CAUSED ONE OF THE TRANSDUCER INTERNAL CONNECTIONS TO SEPARATE. THIS PROBLEM CAUSED THE MAIN OPERATING UNIT (MOU) TO STOP OPERATING AND ACTIVATED THE TROUBLE ALARM AS THE SYSTEM WAS DESIGNED TO DO. THE TRANSDUCER HAS BEEN RETURNED TO THE MFR FOR EVALUATION OF THIS PROBLEM. THIS IS AN ISOLATED INCIDENT AND NO ACTION WILL BE INSTITUTED AT THE PRESENT TIME.
A POSSIBLE SENSITIVITY REACTION WHICH WAS FIRST REPORTED TO CO ON 2/26/96. THE PT COMPLAINED OF AN ACHING PAIN IN THE WRIST DURING TREATMENT. HE DISCONTINUED USE OF THE DEVICE AFTER TWO TREATMENTS. THE DEVICE WAS RETURNED TO CO ON 3/18/96 FOR A COMPLETE CHECK. THE SYSTEM WAS FOUND TO BE OPERATING WITHIN THE PRESCRIBED PARAMETERS. A REPORT WAS SENT TO HIS PHYSICIAN.
THE AVERAGE AGE AT TIME OF COCHLEAR IMPLANTATION WAS 48 YEARS (SD 16 YRS). AFTER TWO YEARS OF USE, THERE IS NO EVIDENCE OF ANY CONSISTENT CHANGE IN THE PSYCHOPHYSICAL PARAMENTERS OF ADULTS. (*)
IN THE FIRST ANNUAL REPORT SUBMITTED ON 6/30/95, DATA FROM 52 CHILDREN WERE SUBMITTED. SINCE THAT TIME, THREE CHILDREN HAVE WITHDRAWN FROM THE STUDY FOR VARIOUS REASONS. CRANIAL NERVE DATA ON 42 SUBJECTS WAS SUBMITTED ON 3/7/96. AT THAT TIME CRANIAL NERVE EVALUATIONS WERE NOT AVAILABLE FOR SEVEN CHILDREN FROM ONE CLINICAL SITE. SINCE THAT TIME, A MINIMUM OF ONE CRANIAL NERVE EVALUATION HAS BEEN REPORTED FOR ALL 49 SUBJECTS CURRENTLY ENROLLED. IN THE 3/96 REPORT, ELEVEN CHILDREN OBTAINED A RATING OTHER THAN 5 (NORMAL POWER, FUNCTION OR SYMMETRY) ON SOME TEST MEASURE. SUBSEQUENT EVALUATIONS HAVE BEEN PERFORMED ON FIVE OF THESE CHILDREN WITH ALL OF THE ASSESSED MEASURES RECEIVING A RATING OF 5. IN ADDITION, ALL OTHER CRANIAL NERVE DATA RECEIVED SINCE MARCH INDICATES NORMAL CRANIAL NERVE FUNCTION.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED WITH A 00-5220-013-00.
CUSTOMER REPORTED A STRIKETHROUGH AT WAIST LEVEL SUBSEQUENT TO PROLONGED LEANING ON THE OPERATING ROOM TABLE.
CUSTOMER REPORTED THAT LATCH DID NOT LOCK AND, WHILE IN USE, ROTOR CAME OFF THE CENTRIFUGE. THERE WAS NO REPORT OF INJURY OR EXPOSURE.
CO HAS INTERNALLY DISCOVERED A CALCULATION ERROR IN THE DOSE PLANNING SYSTEM AND ITS PREDECESSOR. NO COMPLAINTS CONCERNING THIS MATTER HAVE BEEN RECEIVED FROM ANY OF THE SYSTEM USERS. THE ERROR MAY, UNDER UNUSUAL CIRCUMSTANCES, RESULT IN MISCALCULATION OF THE DISTANCE FROM THE SKULL BOUNDARY TO THE TARGET. THEORETICALLY, THIS COULD RESULT IN A LOWER DOSE THAN PRESCRIBED TO THE TARGET. THIS COULD HAPPEN ONLY FOR SUPERFICIAL TARGETS, USING THE DEVICE CLOSE TO ITS VERY LIMITS. PRELIMINARY INVESTIGATIONS SHOW THAT THE UNDERDOSE IS WITHIN NORMAL ACCEPTED CLINICAL FLUCTUATIONS. INVESTIGATION WILL CONTINUE AND CO WILL INFORM FDA IF ANY SIGNIFICANT CHANGE IN THE PRELIMINARY CONCLUSIONS ARE MADE. GAMMA KNIFE USERS HAVE BEEN INFORMED AND THE SOFTWARE IS BEING UPDATED.
DURING SURGERY, THE TIP OF A HANDPIECE (24 KHZ NEURO SHORT) BROKE OFF. THE SURGEON WAS PERFORMING A "RE-DO" BRAIN TUMOR WITH THE POWER SETTING ON THE CONSOLE AT 90%. THE HANDPIECE WAS VIBRATING AS EXPECTED, WHEN APPROX 1" OF THE TIP BROKE OFF. THE SURGEON RETRIEVED THE BROKEN TIP AND FINISHED THE SURGERY WITH THE LONG NEURO HANDPIECE WITH NO FURTHER INCIDENT. NO HARM TO THE PT WAS NOTED.
FACILITY REPORTED THAT SHORTLY INTO HEMODIALYSIS TREATMENT, THE NURSE NOTICED THAT THE DIALYSATE LINES TO AND FROM THE DIALYZER WERE BRIGHT RED. THERE WAS A BLOOD LEAK ON A FIRST USE DIALYZER. EBL >100CC. THERE WAS NO PT INJURY REPORTED.
FACILITY REPORTED THAT 5 MINS INTO HEMODIALYSIS TREATMENT THE PT COMPLAINED OF PAIN IN THE LOWER BACK RADIATING TO THE ABDOMEN. TREATMENT WAS STOPPED AND THE PT FELT BETTER. TREATMENT WAS RESUMED USING A DIFFERENT DIALYZER WITHOUT FURTHER INCIDENT.
FACILITY ALLEGED THAT A PT HAD A REACTION TO A FIRST USE DIALYZER.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK ON A FIRST USE DIALYZER. EBL >200CC. SAMPLE WAS DISCARDED.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK ON A 2ND USE DIALYZER. EBL 250CC. SAMPLE ENVELOPE WAS SENT TO THE FACILITY ON 6/21/96.
BALLOON RUPTURED AFTER SEVERAL DILATATIONS, LAST DILATATION AT 13 ATM. SMALL PIECE OF BALLOON MATERIAL REMAINED IN PT.
ARROW INTL. 3000 BERNVILLE RD, READING, PA 19605. SINCE THE REPORT SOURCE WISHES TO REMAIN ANONYMOUS, AND NO SAMPLE WAS RETURNED, ARROW'S INFO IS LIMITED TO THE ATTACHED MDR SUBMISSION.
SINGLE NEEDLE AV FISTULA PLACED IN ARTERIAL VENOUS GRAFT FOR DIALYSIS TREATMENT. AFTER TREATMENT INITIATED, FLUID LEAKED AT FEMALE LUER FITTING. A CRACK WAS NOTED AT FEMALE LUER FITTING CONNECTION.
WITHIN 1 TO 3 DAYS PT AHD ULCERATIONS AND BURNING OF LIP AND TONGUE AFTER ROUTINE DENTAL PROPHYLAXIS. RESPONDED TO MEDICATED RINSE.
WITHIN 1 TO 3 DAYS PT HAD ULCERATIONS AND BURNING OF LIP AND TONGUE AFTER ROUTINE DENTAL PROPHYLAXIS. RESPONDED TO MEDICATED RINSE. DATE OF BIRTH 1924.
WITHIN 1 TO 3 DAYS PT HAD ULCERATIONS AND BURNING OF LIP AND TONGUE AFTER ROUTINE DENTAL PROPHYLAXIS. RESPONDED TO MEDICATED RINSE. DATE OF BIRTH 1968.
WHEN THE PT WAS INJECTED, THE RADIOPHARMACEUTICAL LEAKED OUT OF THE SYRINGE AT THE HUB OF THE NEEDLE OR DISTAL END OF SYRINGE CAUSING ISOTOPE TO SPILL ON TO PT'S ARM INSTEAD OF GOING INTO VEIN. RADIATION CONTROL CONSIDERS THIS AN INCIDENT AND DOES NOT HAVE TO BE REPORTED TO THE STATE.
PROBE SHAFT SEPARATES ITSELF FROM THE BASE. IF A PROBE COVER IS ATTACHED TO THE PROBE, IT HAS THE POTENTIAL OF BEING PROPELLED INTO THE PT'S MOUTH AND THROAT. PROBE TIP BREAKS OFF. IT IS A POTENTIAL CHOKING HAZARD.
RESIDENT HAD A RAISED TOILET IN BATHROOM. WHILE TOILETING, TOILET SEAT FLIPPED OUT FROM UNDER HIM CAUSING HIM TO FALL. NO INJURIES WERE NOTED TO RESIDENT BUT POTENTIAL EXISTS, BECAUSE RAISED SEAT DOES NOT PHYSICALLY ATTACH TO TOILET BUT RESTS ON TOP.
WHILE ATTEMPTING TO DEPLOY A STENT, THE STENT BECAME DISLODGED FROM THE BALLOON AND WAS PARTIALLY DEPLOYED IN THE PROXIMAL CIRCUMFLEX ARTERY AND BACK INTO THE LEFT MAIN CORONARY ARTERY. THIS RESULTED IN THE ACUTE CLOSURE OF THE CIRCUMFLEX AND PT TO EMERGENCY BYPASS SURGERY.
SEMIAUTOMATIC DEFIBRILLATOR FAILED TO ASSESS ELECTRICAL ACTIVITY OR TO CHARGE IN ORDER TO DELIVER A DEFIBRILLATORY PULSE. THE CAUSE OF THIS APPEARS TO BE A FAILURE WITHIN THE TAPE DRIVE MECHANISM TO DETECT THAT THE TAPE DOOR IS CLOSED. THE TAPE DOOR CLOSURE IS REQUIRED IN ORDER FOR THE DEFIBRILLATOR TO ASSESS OR CHARGE. APPROX ONE MONTH AGO, THE UNIT EXPERIENCED A SINGLE OCCURRENCE WHERE THE TAPE DRIVE SYSTEM FAILED TO RETRACT FROM THE TAPE CASSETTE PREVENTING REMOVAL OF THE CASSETTE. THE TAPE DOOR WAS CYCLED ONCE OR TWICE AND THE TAPE DRIVE SYSTEM RETRACTED AND THE CASSETTE WAS REMOVED. NO ADD'L ACTION WAS TAKEN. ON 7/14, DURING A TRAINING SESSION, THE SAD WAS ACTIVATED WITH A PT SIMULATOR ATTACHED. FOLLOWING ACTIVATION A "CLOSE TAPE DOOR" MESSAGE WAS RECEIVED. THE TAPE DOOR WAS CYCLED OPEN THEN CLOSED AND THE SAD WAS REACTIVATED. AN "ASSESSING - HAND OFF" MESSAGE WAS ANNUNCIATED FOLLOWED BY A "CHECK TAPE" MESSAGE. THE UNIT WAS POWERED OFF AND THE TAPE DOOR WAS OPENED AND THE TAPE WAS CHECKED. THE TAPE DRIVE MECHANISM HAD JAMMED SUCH THAT WHEN THE DOOR WAS OPENED THE CASSETTE COULD NOT BE REMOVED. THE DOOR WAS CYCLED SEVERAL TIMES IN AN ATTEMPT TO CAUSE THE MECHANISM TO RETRACT. NO RETRACTION OF THE MECHANISM OCCURRED AND THE DOOR WAS CLOSED. THE UNIT WAS REPOWERED AND AN ATTEMPT WAS MADE TO ASSESS. AT THIS TIME THE UNIT REPEATEDLY ANNOUNCED "CLOSE TAPE DOOR" AND WOULD NOT ASSESS THE SIMULATED PT OR CHARGE FOR DEFIBRILLATION. MFR WAS CONTACTED REGARDING THIS INCIDENT AND THEY ADVISED THAT THEY HAD AN ENGINEERING CHANGE TO THE TAPE DRIVE UNIT THAT WAS BEING PERFORMED AS UNITS WERE RETURNED TO THE MFR FOR OTHER REASONS. THIS CHANGE WAS TO REPLACE CERTAIN BELT(S), SPRING(S), AND PULLEY(S) ACCORDING TO THEIR TECHNICIAN. RPTR WAS ADVISED BY THE REPAIR SUPERVISOR THAT THE FAILURE RPTR HAD SEEN COULD NOT BE RELATED TO THE USERS THAT THE UNITS HAD BEEN DETERMINED TO NEED MODIFICATIONS TO THE TAPE DRIVE. THEIR COMMENTS WERE THAT THIS WOULD BE PICKED UP ON A ROUTINE FACTORY PERFORMED PREVENTIVE MAINTENANCE CHECK. CO LITERATURE, HOWEVER, DOES NOT RECOMMEND A ROUTINE FACTORY PREVENTIVE MAINTENANCE EXAMINATION OF THESE UNITS. BASED UPON THE INFO AVAILABLE RPTR'S INTERNAL CHECKS OF OPERATION AND UNIT INTEGRITY WERE ALL THAT WERE FELT TO BE REQUIRED. EVEN THOUGH RPTR WAS AWARE THAT THE TAPE DRIVE MECHANISM WAS A PORTION OF THE SENSOR SYSTEM TO ALLOW ASSESSMENT AND DEFIBRILLATION OPERATIONS TO OCCUR, IT NEVER OCCURRED TO USER THAT A SIMPLE FAILURE TO DETECT THE TAPE DOOR BEING CLOSED WOULD PREVENT OPERATIONS. THIS INHIBITION APPEARS TO SERVE NO OBVIOUS FUNCTION TO PROTECT EITHER THE PT OR THE OPERATOR. IT SHOULD BE REMOVED FROM THE UNITS AS SOON AS POSSIBLE IN ORDER TO ENSURE THAT NO FAILURES OF THIS TYPE WILL OCCUR DURING PT USE.
THE RUBBER SEPTUM OF THE INJECTION CAP BECAME DISLODGED AND WAS NO LONGER OCCLUDING THE CAP CAUSING THE SYSTEM TO BE OPEN. THE CAP WAS AT THE DISTAL END OF A HUBER NEEDLE EXTENSION TUBE THAT WAS ACCESSED INTO A CLIENT'S CATHETER. THE PT HAD A BLOOD BACK UP AND ACTUALLY BLED OUT OF THE NON-OCCLUDED INJECTION CAP. PT DID CALL THE OFFICE, THE TUBING WAS CLAMPED, BLEEDING STOPPED AND THE RN REPLACED THE CAP.
FOLLOWING IMPLANT OF PACER, PT DEVELOPED RECURRING "SPELLS" OF FAINTNESS, WEAKNESS. MOST OCCURRED IN PAST YEAR. STUDIES CONDUCTED FAILED TO DOCUMENT FAILURE TO SENSE, PACE OR CAPTURE. DUE TO CONTINUED COMPLAINTS AND THE FACT THAT THE LEAD IN QUESTION HAD BEEN KNOWN TO BE FAULTY, COMPLETE CHANGE IN PACEMAKER DONE 6/6. "FAULTY" LEAD CAPPED AND LEFT IN PLACE. GENERATOR EXPLANTED. CO REP IN ROOM AT TIME OF EXCHANGE.
VALVE NOT WORKING PROPERLY. SOME RESISTANCE WHEN IRRIGATING. AFTER REMOVAL VALVE SEEMED TO TEST OKAY BUT REMOVED BECAUSE OF POSSIBLE CONCERN OR VALVE MALFUNCTIONING.
ORIGINAL PACER/LEADS PLACED 4/10. RETURNED TO OFFICE WITH C/O LIGHT-HEADEDNESS. MONITORING SHOWED MALFUNCTION WITH FAILURE TO SENSE AND CAPTURE. VENTRICULAR LEAD REPOSITIONED, ATRIAL LEAD FOUND TO BE DEFECTIVE AFTER TESTING. ATRIAL LEAD REPLACED. REP IN ROOM FOR PROCEDURE. NOT DOCUMENTED IF LEAD TAKEN AT THAT TIME.
CARTRIDGE IS MARKED FOR ACID GAS AND ORGANIC VAPOR USE. HOWEVER, NOTICE PAPER W/CARTRIDGE INDICATES NOT TO BE USED FOR FORMALDEHYDE (ACID GAS).
USE OF DISPOSABLE SCISSORS, PRODUCED TWITCHING OF BOTH LEGS. CAUTERY PAD CHECKED - NO PROBLEMS. OTHER ELECTRICAL INSTRUMENTS NO PROBLEMS. ONLY THESE SCISSORS.
DENTAL IMPLANT FAILED IN FUNCTION. (SEE DEN 1009201).
ON A VENTILATOR WITH COMPRESSOR THE INTERNAL COMPRESSOR IS DESIGNED TO TURN ON WHEN THE EXTERNAL AIR SOURCE PRESSURE FALLS BELOW 32+1 PSI. WHEN ATTACHED TO A BOTTLED AIR SOURCE THE PRESSURE SENSOR SWITCH WILL SOMETIMES TURN THE COMPRESSOR ON AND OFF SEVERAL TIMES IN QUICK SUCCESSION, CAUSING THE POWER CIRCUIT BREAKER TO OPEN. THE PROBLEM WAS DISCOVERED DURING A ROUTINE MAINTENANCE INSPECTION. OTHER SUSPECT VENTILATORS WERE TESTED AND FOUND TO BEHAVE IN THE SAME WAY.
DURING ROUTINE EXPLANT OF VENOUS ACCESS DEVICE, CATHETER WAS REMOVED AND NOTED TO BE SEVERED IN TWO PIECES WITH X-RAY CONFIRMING THAT THE REMAINING PIECE OF CATHETER WAS IN THE PULMONARY ARTERY. PT TAKEN TO SPECIAL PROCEDURES FOR PULMONARY ANGIO AND REMOVAL OF REMAINING PIECE OF CATHETER. DC'D HOME STABLE WITHOUT INJURY. CATHETER WAS FLUSHED IN MARCH BY HOME HEALTH NURSE WITHOUT PROBLEM.
PT HAD UNDERGONE EMERGENCY CORONARY ARTERY BYPASS GRAFTS ON 7/2/96. BALLOON WAS INSERTED AT THAT TIME. ON 7/3/96 AT 1820 THE BALLOON (INTRA-AORTIC) WAS REMOVED BY THE SURGEON AFTER NURSING PERSONNEL NOTICED BLOOD IN THE TUBING. A SIMILAR SIZE AND BRAND BALLOON WAS INSERTED.
DURING CARDIAC CATHETERIZATION, CATHETER COULD NOT BE REMOVED FROM PT BECAUSE IT HAD BECOME ENTRAPPED BY ARTERIAL SHEATH. UPON EXAMINING ARTERIAL SHEATH, THE DISTAL END OF ARTERIAL SHEATH HAD MULTIPLE AREAS OF INFOLDING WHICH CAUSED TRAPPING OF CATHETER. THE DISTAL END OF SHEATH DUE TO INFOLDINGS WAS A POTENTIAL FOR BREAKING INSIDE OF ARTERY.
ELECTRON TRIMMER BAR FELL OUT OF MACHINE. T BAR SCREW WAS FAULTY AND BROKE OFF. NO INJURIES WERE SUSTAINED, BUT BAR DID HIT TABLE AND BOUNCE ON FLOOR AND LEAVE DENT IN FLOOR.
WHILE SETTING UP THE EQUIPMENT DURING SURGERY IT WAS NOTED THAT THE REINFUSION LINE WAS "STUCK" TO THE WASTE BAG. THE TUBING WAS PULLED AWAY FROM THE BAG TEARING A HOLE IN THE WASTE BAG. THE UNIT WAS DISSASSEMBLED AND ANOTHER SET UP.
BROUGHT TO BIOMEDICAL ENGINEERING FOR REPAIR OF BROKEN STIMULUS OUTPUT CONNECTOR. CO REFUSED TO SELL $1.51 REPLACEMENT PART TO HOSP. INSISTED THAT WHOLE UNIT BE RETURNED TO FACTORY FOR REPAIR AT AN ESTIMATED COST OF $300.00 PLUS SHIPPING AND RENTAL FOR AN INTERIM LOANER. REPAIRED WITH SAMPLE SUPPLIED BY LOCAL VENDOR FOR FREE. DURING REPAIR FOUND SEVERAL SMALL SCREWS ROLLING AROUND LOOSE INSIDE THE DEVICE. THE SCREWS WERE INTENDED TO FASTEN THE EXTERNAL PLASTIC FEET TO THE UNIT. THESE HAD BROKEN OFF, APPARENTLY TOO FLIMSY TO SUPPORT THE WEIGHT OF THE MACHINE. ALSO NOTICED THAT THE OLDER VERSION PT ECG/EEG CABLE COULD BE PLUGGED INTO THE REMOTE STIMULUS CONNECTOR ON THE NEWER MACHINE.
PT WAS ADMITTED THROUGH DAY SURGERY WITH TORN MENSISCUS OF LEFT KNEE. LEFT KNEE ARTHROSCOPY WAS SCHEDULED ON 7/10/96. ON OR ABOUT 8:20 AM THE PROCEDURE BEGAN. AT 9:10AM THE PRESSURE SENSOR WAS NOTED TO BE DEFLATED. SENSOR WAS DISCONNECTED AND ALL LINES CHECKED. CASSETTE WAS REINSERTED IN THE ARTHROSCOPY PUMP AND SENSOR ALARM DID NOT SOUND. PROCEDURE WAS COMPLETED AT 9:25 AM. WHEN DRAPES WERE REMOVED SEVERE SWELLING WAS NOTED IN LEFT LOWER EXTREMITY. HOWEVER, PT WAS MONITORED IN RECOVERY ROOM. PEDAL PULSES REMAINED PALPABLE AND VITAL SIGNS STABLE. PT WAS TRANSFERRED OUT OF RR AT 11:45 AM IN STABLE CONDITION AND DISCHARGED HOME LATER THAT AFTERNOON.
TRANSILLUMINATOR BEING USED ON PREMATURE NEONATE FOR IV PLACEMENT. BURN RESULTED DUE TO APPARENT MIXUP OF ELECTRICAL CABLES (GRAY CABLE ATTACHED INSTEAD OF APPROPRIATE WHITE CABLE. AGE AT TIME OF EVENT: 7 WEEKS.
GRADUATED OXYGEN FLOWTUBE WITHIN THE FLOWMETER BREAKS AT THE BASE. THIS CAN CAUSE THE FLOWMETER TO INDICATE ONE FLOW WHILE DELIVERING A MUCH HIGHER FLOWRATE. POTENTIAL DANGER TO COPD PTS.
ACCORDING TO THE PHYSICIAN'S REPORT, PT UNDERWENT PACEMAKER REPLACEMENT AT ANOTHER HOSP IN 1/95. PT HAD BEEN ADMITTED TO REPORTING FACILITY FOR UNSUCCESSFUL PACEMAKER REVISIONS TWICE, WITH SKIN EROSION NOTED BOTH TIMES. PT HAD PERSISTENT DRAINAGE FROM THE EXPOSED AREA OF THE PACEMAKER SYSTEM WITH WIRES THAT HAD ERODED THE SKIN. PT WAS ADMITTED FOR PACEMAKER REMOVAL.
CLIP APPLIER USED DURING A MODIFIED RADICAL MASTECTOMY WITH TISSUE EXPANSION. SURGEON WAS USING THE CLIP APPLIER AND CLIPS WOULD NOT FORM PROPERLY ON THE VESSELS. A NEW CLIP APPLIER WAS OPENED AND USED SUCCESSFULLY. NO INJURY TO PT WAS REPORTED. DEVICE TO BE RETURNED FOR EVALUATION.
DISPOSABLE TISSUE STAPLER USED DURING A GASTRO-J PROCEDURE AND DR COULD NOT FIRE THE TRIGGER. DR REPOSITIONED THE STAPLER AND AGAIN ATTEMPTED TO FIRE. TRIGGER WOULD NOT MOVE. NO INJURY TO PT WAS REPORTED. DEVICE TO BE RETURNED FOR EVALUATION.
DISPOSABLE CLIP APPLIER WOULD NOT FUNCTION. NO INJURY TO PT REPORTED. DEVICE TO BE RETURNED FOR EVALUATION.
TROCAR TIP DID NOT RETRACT UPON ENTRY INTO PERITONEAL CAVITY. TIP ENTERED SURFACE OF LIVER CAUSING MINOR LACERATION THAT STOPPED BLEEDING WITH NO TREATMENT.
LOOPS DID NOT CUT CLEANLY THROUGH THE TISSUE, BUT APPEARED TO DRAG AS WELL AS SOME ARCING WHICH CAUSED BURN. CAUTERIZED TO ASSURE HEMOSTASIS. NO BLEEDING. ADD'L LOT #: 52087-1, 54174-1, 52811-1.
PACKAGE OF ANTIEMBOLISM STOCKINGS SENT TO THE NURSING UNIT FROM THE PHARMACY IN A SEALED PACKAGE. RETURNED BY THE NURSING STAFF BECAUSE THEY FOUND A BEETLE (INSECT) IN THE PACKAGE.
ON 4/23/96, RPTR HAD THE PACEMAKER IMPLANTED. ON TWO SEPARATE OCCASIONS, IT GAVE HIM A RIB SHOCK WHICH SEEMED TO COINCIDE WITH TAKING HIS BLOOD PRESSURE. ON 5/9/96, THE PACEMAKER WAS REMOVED AND ANOTHER ONE PUT IN.
PT WAS DISCOVERED WITH THE TRACHEOSTOMY TUBE OUT, OSTENSIBLY RESULTING FROM MALFUNCTION IN TRACH TIE. PT EXPIRED. AGE AT TIME OF EVENT: 6 YRS, 11 MOS.
ON 6/29/96, FOUR DAYS FOLLOWING THE FAILURE TO RETRIEVE RECORDED DATA FROM A DEVICE, THE PT IN QUESTION PASSED AWAY. THIS DEATH WAS REPORTED BY DR ON 7/2/96. ON 7/3/96, THE DR INFORMED THE SLEEP PRODUCT MGR THAT DEVICE DID NOT CONTRIBUTE TO THE PT'S DEATH.
CLIENT WAS FOUND IN A SITTING POSITION ON FLOOR NEXT TO BED, HER HEAD AND NECK WERE WEDGED BETWEEN 1/2 SIDERAIL AND MATTRESS.
BODY WAS FOUND IN SITTING POSITION ON FLOOR NEXT TO BED. HEAD AND NECK WERE WEDGED BETWEEN 1/2 SIDERAIL AND MATTRESS.
PT ADMITTED WITH A DIAGNOSIS OF PNEUMONIA/ARDS. ON VENTILATOR FOR 3 WEEKS WITH A TRACHEOSTOMY. SIX OTHER VENTILATORS IN USE IN ICU AT THE TIME. PT BECAME DISCONNECTED FROM VENT. STAFF WERE UNABLE TO HEAR VENTILATOR ALARMS AND RESPONDED ONLY WHEN THE CARDIAC MONITOR BRADYCARDIA ALARM SOUNDED. UNABLE TO RESUSCITATE PT. 13 BED ICU UNIT IS LARGE. ADJUSTABLE ALARM VOLUME CONTROL WAS ON LOWEST SETTING. MACHINE DID NOT MALFUNCTION. ALARM VOLUMES WERE CHECKED WITH MFR SPECS USING A DECIBEL METER: LOW-66DBA, HIGH-72 DBA. MACHINE WAS TESTED IN SAME ROOM. ON LOW VOLUME SETTING, ALARM WAS DIFFICULT TO HEAR IN NURSE'S STATION. ALARM TONE SEEMS TO BLEND IN WITH BACKGROUND NOISES, OTHER ALARMS.
WHILE CNAS WERE ATENDING A FACILITY RESIDENT WITH A WHIRLPOOL BATH, SAFETY DEVICE RELEASED AND RESIDENT FELL TO FLOOR. RESIDENT SUBSEQUENTLY DIED. UPON FURTHER INVESTIGATION ON 3/26/96, IT WAS DISCOVERED THAT GROMMETS WERE MISSING AND BATH BELT BUCKLES HAD WHAT APPEARED TO BE STRESS FRACTURES.
RESIDENT WAS ASSISTED TO BED AT 1930. DUE TO NUMEROUS FALLS WHEN STANDING (4 TIMES IN THREE DAYS), THE GUARDIAN REQUESTED SECURING RESIDENT WHEN IN BED. A SOFT BELT SECURITY DEVICE WAS APPLIED AT THE TIME THE RESIDENT WENT TO BED. THE RESIDENT WAS FOUND AT 2205 ON THE FLOOR BESIDE THE BED DEAD. THE BELT WAS AROUND HER WAIST. HER MID-TRUNK WAS ABOUT 6 INCHES OFF THE FLOOR; THE LOWER AND UPPER BODY WERE LYING FLAT ON THE FLOOR. CAUSE OF DEATH HAS NOT BEEN VERIFIED.
PT WITHOUT HEART RHYTHM WHILE ON HEART MONITOR. HEART MONITOR DID NOT ALARM TO IDENTIFY THAT PT WAS WITHOUT A HEART RHYTHM. PT HAD A PACEMAKER. IT IS BELIEVED THAT THE MONITOR COUNTED THE PACER SPIKES AS IF IT WERE A HEART RHYTHM AND DID NOT IDENTIFY A NEED FOR AN ALARM.
DURING DEPLOYMENT OF STENT, THE STENT "FELL" OFF CATHETER AND LODGED IN LEFT VENTRICLE. ATTEMPTS WERE MADE TO REMOVE STENT, BUT UNSUCCESSFUL. POST PROCEDURE PT CODED AND DIED 12 HRS POST PROCEDURE "DEATH."
RESIDENT INADVERTENTLY RECEIVED 800 CC OF TUBE FEEDING OVER 3 HR PERIOD. NO ALARM SOUNDED. RESIDENT TRANSFERRED TO HOSP AND EXPIRED.
ORAL-GASTRIC FEEDING TUBE WAS BEING REMOVED FOR WEEKLY CHANGE ON NEWBORN. ON REMOVAL, NURSE NOTED THAT TIP WAS BARELY CONNECTED. TIP EASILY DISCONNECTED WHEN CHECKED.
ADDITIONAL CLINICAL INFO WAS REC'D FROM THE USER FACILITY ABOUT THE TWO PTS WHO DEVELOPED PULMONARY EDEMA AFTER LMA USE. THE FIRST PT A 23 YEAR OLD MALE, WEIGHING 175 POUNDS, IS A PROFESSIONAL MOUNTAIN BIKE RACER WHO HAD AN INCISION AND DRAINAGE OF HIS KNEE. THE LARYNGEAL MASK AIRWAY WAS PLACED SMOOTHLY AFTER INDUCTION WITH PROPOFOL 200 MG, LIDOCAINE 50 MG, AND 200 MCG OF FENTANYL. THERE WERE NO DIFFICULTIES UNTIL FIVE MINUTES AFTER THE START OF THE PROCEDURE, WHEN THE PT BECAME RIGID AND THE CLINICIAN BELIEVED THE PT TO BE EXPERIENCING LARYNGOSPASM. SUCCINYLCHOLINE (20 MG) WAS ADMINISTERED, AND APPROXIMATELY 45 MINUTES LATER THE PT DEVELOPED NEGATIVE PRESSURE PULMONARY EDEMA. THE PT WAS PLACED IN INTENSIVE CARE UNIT FOR 24 HOURS, AND HIS SYMPTOMS RESOLVED WITHOUT SEQUELAE. THE INFO REPRESENTS ADDITIONAL CLINICAL INFO PERTAINING TO THE PTS INVOLVED AND DOES NOT CHANGE THE CONCLUSIONS OF THE PRIOR REPORT. THIS REPORT WILL BE CONSIDERED CLOSED UNLESS ADDITIONAL INFO IS REC'D.
ADDITIONAL CLINICAL INFO WAS REC'D FROM THE USER FACILITY ABOUT THE TWO PTS WHO DEVELOPED PULMONARY EDEMA AFTER LARYNGEAL MASK AIRWAY USE. THE SECOND PT, A 29 YEAR OLD MALE, WEIGHING 185 POUNDS, IS A PROFESSIONAL FOOTBALL PLAYER WHO HAD ROUTINE KNEE ARTHROSCOPY. THE LARYNGEAL MASK AIRWAY WAS PLACED SMOOTHLY AFTER INDUCTION WITH PROPOFOL 150 MG, FENTANYL 250 MCG, AND MIDAZOLAM 2 MG. FORTY-FIVE MINUTES INTO THE PROCEDURE, THE PT REC'D NEW STIMULATION AND DEVELOPED LARYNGOSPASM. SUCCINYLCHOLINE WAS ADMINISTERED AND THE PT WAS INTUBATED. APPROXIMATELY 45 MINUTES LATER, THE PT WAS NOTED TO HAVE DEVELOPED PULMONARY EDEMA. THE PT WAS PLACED IN INTENSIVE CARE UNIT FOR ONE DAY, AND HIS SYMPTOMS RESOLVED WITHOUT SEQUELAE. THE INFO REPRESENTS ADDITIONAL CLINICAL INFO PERTAINING TO THE PTS INVOLVED AND DOES NOT CHANGE THE CONCLUSIONS OF THE PRIOR REPORT. THIS REPORT WILL BE CONSIDERED CLOSED UNLESS ADDITIONAL INFO IS REC'D.
PT CALLED CASE MGR AT HOMECARE AGENCY ON 7/10/96 TO INFORM HER THAT THE OXYGEN CONCENTRATOR HAD MALFUNCTIONED IN THE NIGHT OF 7/9/96 AND THAT AFTER BEING PLACED ON EMERGENCY BACK-UP TANK, PT DID REQUIRE TRANSPORT TO LOCAL ER FOR EVALUATION/TREATMENT. PT STATES THAT EQUIPMENT HAD BEEN CHECKED, SERVICED BY HIS REP EARLIER THAT DAY.
PT WAS DIAGNOSED WITH CANCER. PT'S RIGHT BREAST WAS REMOVED AND BREAST PROSTHESIS WAS IMPLANTED. BREAST IMPLANT WAS OVER-FILLED WITH SALINE AND RUPTURED. PT MOVED TO ANOTHER STATE AND NOW PT IS NOT ON TREATMENT DUE TO FINANCIAL PROBLEMS. PT STATED "I DON'T FEEL LIKE A WOMAN, I FEEL LIKE A LEPER AND THIS HAS BEEN A BAD EXPERIENCE FOR ME."
FOLLOWING IMPLANT OF PACER, PT DEVELOPED RECURRING "SPELLS" OF FAINTNESS, WEAKNESS. MOST OCCURRED IN PAST YEAR. STUDIES CONDUCTED FAILED TO DOCUMENT FAILURE TO SENSE, PACE OR CAPTURE. DUE TO CONTINUED COMPLAINTS AND THE FACT THAT THE LEAD IN QUESTION HAD BEEN KNOWN TO BE FAULTY, COMPLETE CHANGE IN PACEMAKER DONE 6/6. "FAULTY" LEAD CAPPED AND LEFT IN PLACE. GENERATOR EXPLANTED.
TWO ATTEMPTS WERE MADE TO RESTART IV WITH TWO DIFFERENT 22 GAUGE IV CATHETERS AND NEITHER ONE WOULD PENETRATE THE SKIN. THE SHEATH OVER THE NEEDLE WAS TOO CLOSE TO THE TIP TO ALLOW EASE OF PENETRATION, CAUSING PAIN AND DISCOMFORT TO THE PT.
WHEN RETURNING RESIDENT TO BED FROM WHEELCHAIR VIA LIFT, ONE OF THE HOOKS FROM THE SLING WHICH HAS A 400 LB CAPACITY, BENT. THIS RESULTED IN THE RESIDENT FALLING TO THE FLOOR. POST INCIDENT, RESIDENT HAS BEEN SO FEARFUL OF USING LIFT THAT SHE HAS REMAINED ON BEDREST REFUSING ITS USE. THIS HAS IMPEDED THE PROGRESS RESIDENT MADE IN PHYSICAL THERAPY AND HAS LENGTHENED HER STAY UNNECESSARILY. RESIDENT WAS EXAMINED AND SEEN BY MD THE DAY OF THE INCIDENT. POST INCIDENT, RESIDENT C/O LEFT ARM PAIN AND SUFFERED SMALL SCRATCH TO NOSE.
TO ER 5/29/96 VIA AMBULANCE. APPARENTLY DEVELOPED INFECTION AT PACER SITE AND SKIN OPENED UP EXTRUDING THE PACER OUT OF THE POCKET. HEART RATE 48. MONITOR SHOWS PACER SPIKES WITHOUT ANY CAPTURE. 5/30/96 PLACEMENT OF PERMANENT TRANSVENOUS PACEMAKER VIA RIGHT SUBCLAVIAN VEIN AND REMOVAL OF LEFT SIDE PACEMAKER WITH CAPPING AND WIRE.
PT WAS ADMITTED FOLLOWING EPISODE OF SYNCOPE. PT HAD SYNCOPE ASSOCIATED WITH ASYSTOLE IN HOSP. PERMANENT PACER PLACED. PT HAD CARDIAC ARREST 4/5/96, 4/6/96. PACEMAKER FAILED TO CAPTURE. UNSUCCESSFUL RESUCITATION, PT EXPIRED ON 4/6/96. NO AUTOPSY WAS DONE.
PT EXPIRED FOLLOWING MYOCARDIAL INFARCTION AND CARDIAC ARREST APPROX 90 MINS AFTER A HEMODIALYSIS TREATMENT. THE PT'S DIALYSIS WAS TERMINATED EARLY DUE TO A SUSPECTED PYROGEN REACTION. SUBSEQUENT INVESTIGATION INDICATES THAT THE REVERSE OSMOSIS SYSTEM (RO) USED TO TREAT THE WATER FOR REPROCESSING DIALYZERS HAD A RUPTURED MEMBRANE. REVERSE OSMOSIS PUMP HAD FAILED, AND PIECES OF THE BROKEN PUMP WERE FOUND IN THE RUPTURED REVERSE OSMOSIS MEMBRANE. IT IS UNKNOWN AS TO WHETHER THERE IS ANY ASSOCIATION BETWEEN THE SUSPECTED PYROGEN REACTION AND THE PT DEATH. SEVEN OTHER PTS ALSO EXPERIENCED SUSPECTED PYROGEN REACTIONS DURING THE SAME MORNING: SIX OF WHOM RECOVERED AND LEFT THE FACILITY THAT MORNING; THE SEVENTH PT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION AND WAS DISCHARGED THE NEXT DAY HAVING RECOVERED WITH NO INTERVENTION.
UPON ARRIVAL IN CATH LAB THE PT WAS INTUBATED AND ARRESTING. CARDIOLOGIST WANTED TO INSERT AN IAB CATHETER PRIOR TO PTCA. PERFUSIONIST ESTABLISHED EKG AND PRESSURE WAVEFORM. THE BALLOON WOULD NOT FILL. PHYSICIAN TRIED MANUAL INFLATION WITH 60CC SYRINGE WITHOUT SUCCESS. PHYSICIAN TRIED MOVING SHEATH BACK, BUT STILL NO FILL. PROCEDURE WAS COMPLETED WITHOUT IABP. PT DIED AT 2033.
PT HAD AN AUGMENTATION MAMMOPLASTY APPROX 18 YRS AGO. ON 4/26/96 PT SUFFERED A BILATERAL CAPSULAR CONTRACTION AND RUPTURE OF THE RIGHT SILICONE IMPLANT. OPEN CAPSULOTOMY; REMOVAL OF IMPLANT AND IMPLANT MATERIAL AND EXCHANGE OF IMPLANTS WAS PERFORMED.
PT TRIPPED ON IV AND BROKE OFF EXTERNAL PORTION OF HER PICC LINE AND MOST PROBABLY EXPERIENCED AIR EMBOLI. SHE LOST CONSCIOUSNESS FOR ONE MIN WITH FOAMING/AIR BLOCKAGE. CODE (CPR) TEAM RESPONDED, PT REGAINED CONSCIOUSNESS AND WAS TAKEN TO CT FOR REMOVAL OF REMAINING CATHETER. PT TRANSFERRED TO MICU WHERE SHE REMAINED STABLE.
DURING NURSING ROUNDS AT 8:00 PM, PT WAS OBSERVED TO BE SLEEPING. DURING ROOM CHECK AT 9:30 PM, PT WAS FOUND WITH HER HEAD THROUGH THE MIDDLE OPENING OF TOP RIGHT BEDRAIL. PT WAS ANXIOUS AND MOVING HEAD FROM SIDE TO SIDE. HEAD BECAME WEDGED IN OPENING AND SIDERAIL HAD TO BE CUT WITH BOLT CUTTERS TO RELEASE HEAD. PT HAD ABRASIONS TO SIDE OF NOSE AND NASAL DISTORTION, AND SOFT TISSUE SWELLING OF CHEEKS AND EYELIDS. NO RESPIRATORY DISTRESS OBSERVED. PT UTILIZED MOUTH BREATHING UNTIL HEAD WAS RELEASED. PT WAS ABLE TO BE TRANSFERRED BACK TO THE NURSING HOME ON 6/3/96.
PT HAD SILICONE BREAST IMPLANTS REMOVED BILATERALLY. BOTH THE RIGHT AND LEFT IMPLANTS WERE RUPTURED. ALSO THE BREAST WERE ENCAPSULATED. THE SALINE IMPLANTS WERE INSERTED BILATERALLY.
PT HAD SILICONE IMPLANTS REMOVED FROM BREAST. REPLACED WITH SALINE IMPLANTS. THE RIGHT BREAST IMPLANT WAS RUPTURED AND SLIGHTLY CAPSULATED. THE LEFT BREAST WAS CAPSULATED.
STENT DELIVERED TO LESION SITE IN LAD. BALLOON INFLATED TO 9ATM FOR 45 SECS. BALLOON CATHETER REMOVED. 3.0 STENT FAILED TO DEPLOY.
WHILE MD ATTEMPTED TO PULL G-TUBE, RESISTANCE WAS NOTED. G-TUBE THEN SNAPPED AND A PIECE WAS NOTED TO BE BROKEN OFF. PT TAKEN TO GI LAB FOR ENDOSCOPY AND REMOVAL OF THE INTERNAL BOLSTER OF THE TUBE FROM THE PT'S GASTRIC POUCH. PT RECOVERED WITH NO FURTHER PROBLEMS.
BLUE PORT OF CATHETER WAS FOUND TO BE SEPARATED AT THE HUB. TEMP PORT CLAMPED TO PREVENT FURTHER BLOOD LOSS.
PRODUCT LEAKING BROWNISH YELLOW FLUID FROM HANDPIECE WHERE BATTERIES ARE LOCATED.
BURNS NOTED AT THE CORNER OF CHILD'S MOUTH WHEN MOUTH GAG WAS REMOVED AT THE END OF CASE. NEEDLE BOVIE TIP WAS USED IN THE PROCEDURE. BOTH SIDES OF CHILD'S MOUTH SUTURED AND BACITRACIN OINTMENT APPLIED.
PRIOR TO CERVICAL LAMINECTOMY, THE PT HAD PLACEMENT OF A #6 FR VENOUS CATHETER IN THE RIGHT MID-ATRIUM FROM THE RIGHT ANTECUBITAL FOSSA. POST OPERATIVELY ON 6/1/96, SHE DEVELOPED CARDIAC TAMPONADE WHICH NECESSITATED PERICARDIOCENTESIS. MEDWATCH FILED DUE TO UNANSWERED QUESTION OF WHETHER OR NOT CARDIAC TAMPONADE MAY HAVE BEEN RELATED TO THE RIGHT ATRIAL CATHETER. THE PT RESPONDED WELL TO PERICARDIOCENTESIS AND WAS DISCHARGED FROM THE HOSP 6 DAYS AFTER THIS EVENT.
A #6 FR STRAIGHT 70 CM CATHETER REPORTEDLY PLACED IN RIGHT ATRIUM VIA RIGHT ANTECUBITAL PRIOR TO CERVICAL LAMINECTOMY, DISCECTOMY (C3-C6). REPORTEDLY HYPOTENSIVE POST OPERATIVELY REQUIRING VASOPRESSORS FOR BP SUPPORT. RETURNED TO OR 5/11/96 DUE TO ABDOMINAL COMPLAINTS FOR EXPLORATORY LAPAROTOMY AND CHOLECYSTECTOMY. PERICARDIOCENTESIS DONE 5/12/96 FOR PERICARDIAL EFFUSION WITH IMPROVEMENT OF CARDIAC TAMPONADE REPORTED. EFFUSION REPORTEDLY PRESENT AGAIN ON 5/13/96 WITHOUT EVIDENCE OF TAMPONADE. ON 5/14 REPORTEDLY EXPERIENCING TAMPONADE, SEPTIC SHOCK, MULTIPLE ORGAN FAILURE. ON 5/15 ECHOCARDIOGRAM REPORTEDLY SHOWED NO PERICARDIAL EFFUSION, NO TAMPONADE. EXPIRED 5/15/96. REPORT SUBMITTED DUE TO UNRESOLVED QUESTION OF WHETHER RIGHT ATRIAL CATHETER CONTRIBUTED TO PERICARDIAL EFFUSION AND TAMPONADE. AUTOPSY REPORTEDLY SHOWED NO PERFORATION.
FOUND COLLAPSED IN A PARKING LOT NEAR HIS HOME. BROUGHT TO THE EMERGENCY DEPT VIA AMBULANCE. EMERGENCY RESUSCITATION UNSUCCESSFUL. MEDICAL EXAMINER CALLED.
FOLLOWING TRANSLUMINAL ATHERECTOMY, THE LAD WAS FOUND TO SHOW SIGNS OF PERFORATION. THE PT WAS STABILIZED AND TRANSFERRED TO THE OR FOR EMERGENCY LAD REPAIR.
A PHYSICIAN WAS USING THIS INSTRUMENT DURING EYE SURGERY WHEN HE NOTICED THE INSTRUMENT TIP WAS MISSING. X-RAYS WERE NEEDED OF THE EYE TO DETERMINE WHETHER OR NOT THE TIP COULD BE LOCATED. THE X-RAYS WERE NEGATIVE.
WARMING BLANKET WAS BEING USED CORRECTLY ON PT. AFTER APPROX 15 MIN OF USE PT BEGAN TO C/O PAIN. SKIN ON LEGS WAS RED. NO VISIBLE BLISTERS NOTED. NO PERMANENT INJURY.
DURING PTCA PROCEDURE, BALLOON WAS INSERTED IN LAD AND BURST. LEFT MAIN ARTERY WAS DISSECTED. PT REQUIRED SURGERY FOR REPAIR.
T-CONNECTOR FOUND CRACKED WITH ESTIMATED BLOOD LOSS 35CC (50% OF INFANT'S BLOOD VOLUME) BASELINE MAP 39. AT INCIDENT HCT 23 + MAP 26. REQUIRED OXYGEN AND PLASMANATE IV PUSH STAT AND BLOOD TRANSFUSION X2.
FOUR DEVICES LEAKED BLOOD CARIOPLEGIA AT THE WATER OUTLET. DATE OF EVENT 5/1 - 31/96.
SECOND STAGE RIGHT BREAST CONSTRUCTION. REMOVAL OF EXPANDER AND PLACEMENT OF IMPLANT. CAPSULE NOTED WITH GRANULATION TISSUE. ADDITIONALLY PORT REMOVED; RIGHT NIPPLE AREOLAR RECONSTRUCTION.
REMOVAL OF RUPTURED IMPLANT (SALINE EXPANDER). PT NOTED DECREASE IN SIZE OVER LAST THREE MONTHS. ON 2/96 EXCHANGE OF LEFT TISSUE EXPANDER DUE TO RUPTURE. PLACED: 800CC REMATE FILL VALUE TISSUE EXPANDER WITH 600CC OF SALINE.
REMOVAL OF IUD (PLACED 11/92) DUE TO HEMORRHAGE AND EASY BRUISING.
PT ADMITTED COMPLAINING OF PAIN IN LEFT KNEE. HAS HAD MULTIPLE SURGERIES ON LEFT KNEE. IN 1983 HAD A TOTAL KNEE REPLACEMENT AND IN 1988 HAD A REVISION ARTHROPLASTY. RECENTLY HEARD A POP IN HIS KNEE AND HAD SOME SWELLING. 6/24/96 ARTHROSCOPY SHOWED EVIDENCE OF ABNORMAL POLYTHYLENE WEAR OF THE PATELLA WITH POLYTHELENE SYNOVITIS.
IT WAS REPORTED THAT THE DEVICE STOPPED RUNNING WITHOUT ALARM.
IT WAS REPORTED THAT THE VENTILATOR STOPPED RUNNING AND RESTARTED WITH AUDIBLE ALARM. ONCE THE VENTILATOR STOPPED RUNNING, DID NOT RESTART AND REMAINED QUIET.
WHILE USING THE VIEWING WAND, IT WAS DISCOVERED THAT THE TRAJECTORY AND PERPENDICULAR VIEWS DO NOT UPDATE PROPERLY WHILE THE SOFTWARE IS IN THE FROZEN MODE. AFTER THE SURGEON DEFINES THE TRAJECTORY WHILE IN THE ACTIVE MODE, THE SCREEN IS THEN FROZEN. THE OPERATOR CLICKS ON THE TARGET TO DETERMINE THE DISTANCE FROM THE TIP OF THE PROBE TO THE FROZEN POINT. IN THIS INSTANCE, BOTH THE IMAGE TRAY AND THE NUMERICAL DISTANCE VALUE APPEAR TO BE TWICE THE VALUE OF THE INITIAL CHOSEN ANATOMICAL POINT.
BLOOD FOUND TO BE BACKED-UP TO THE POINT OF THE TRANSDUCER PIGTAIL. THE PORT IMMEDIATELY PROXIMAL TO THE PT WAS FOUND TO BE CRACKED AND WAS LEAKING IV FLUID AND BLOOD. AS A RESULT, THE PT REQUIRED A BLOOD TRANSFUSION OF 15CC'S. AN INVESTIGATION OF THE EVENT REVEALED THAT THERE WAS A CRACK IN THE DEVICE AT THE ZEROING STOPCOCK. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT FOUR OTHER TRANSDUCERS HAD FAILED AND WERE LEAKING ON OTHER PTS. NO ADVERSE EVENTS WERE REPORTED FOR THE OTHER DEVICE FAILURES. ALL DEVICE EVENTS OCCURRED IN THE NICU.
AT THE END OF A SURGICAL PROCEDURE ON THE SHOULDER, AN AREA ON THE RIGHT THIGH WAS NOTED TO BE BURNED WHERE THE ELECTROSURGICAL DISPERSIVE ELECTRODE HAD BEEN PLACED. THE BURNED AREA WAS EXCISED AND SUTURED AND DRESSED.
3-CHANNEL IV PUMP WAS IN USE WITH TPN ON CHANNEL A OR B AND MAINTENANCE FLUID IN CHANNEL C. THE NURSE NOTED NO FLUID DRIPPING AND FLUID LEVEL ON IV BAG NOT DECREASING AS WOULD BE EXPECTED FOR AMOUNT OF FLUID THAT SHOULD HAVE INFUSED. THE IV PUMP REPORTED 653CC'S SO FAR INFUSED ON DAY SHIFT AND 582 CC'S SO FAR INFUSED ON NIGHTS. IT WAS THEN NOTED PUMP DISPLAY ON CHANNEL A OR B READ "SERVICE". THERE WAS NO ALARM TO NOTIFY NURSE OF SERVICE NEED. PT DISPLAYED NO OBVIOUS HARM; HOWEVER, DID NOT RECEIVE PRESCRIBED TPN.
RPTR WAS USING THE SNARE TO REMOVE POLYP. THE POLYP WAS ENCIRCLED WITH THE SNARE AND RPTR WAS ATTEMPTING TO EXCISE AND FULGERATE AS USUAL. THERE WAS NO FULGERATION-COAGULATION ELECTRICITY GOING THROUGH THE SNARE. RPTR IMMEDIATELY OPENED ANOTHER NEW SNARE AND WAS SUCCESSFUL WITH THE PROCEDURE WITH THE NEW SNARE.
BIL. CAPSULAR CONTRACTURES, RT IMPLANT RUPTURED. EXPLANTED 7/1/96.
ACCORDING TO THE H&P, A CENTRAL VENOUS CATHETER, WHICH HAD BEEN PLACED IN THE ER BECAME DISLODGED AND THE CATHETER ACTUALLY MIGRATED DOWN INTO THE SUPERIOR VENA CAVA AND EVENTUALLY DOWN INTO THE HEART WHERE THE SUPERIOR PORTION WAS ABOVE THE ATRIOVENTRICULAR VALVE. PRIOR TO ITS MIGRATION, A SURGEON SAW THE PT AND TRIED TO REMOVE IT THROUGH THE SUBCLAVIAN VEIN UNSUCCESSFULLY. AT THAT POINT, A CARDIOLOGIST WAS CONSULTED AND A HEART CATHETERIZATION WAS PERFORMED WITH SNARING OF THE CATHETER AND SUBSEQUENT REMOVAL.
PT WAS RECEIVING MAGNESIUM SULFATE VIA AN INFUSION PUMP. THE PT'S PHYSICIAN ORDERED THE MEDICATION STOPPED. A STAFF RN STOPPED THE INFUSION BY PUSHING THE APPROPRIATE BUTTON. THE STAFF MEMBER THEN LEFT THE ROOM, WITHOUT YET DISCONNECTING THE IV FROM THE PT. APPROX 20 MINS LATER STAFF ENTERED THE ROOM AND FOUND THAT THE PUMP DOOR WAS OPENED AND TUBING WAS OUTSIDE THE PUMP STILL CONNECTED TO THE PT. THIS CREATED A FREE FLOWING IV TO THE PT. IT IS ESTIMATED THAT THE PT RECEIVED APPROX. 178CC OF IV (LACTATED RINGERS WITH MAGNESIUM SULFATE). IT IS UNKNOWN WHO OPENED THE PUMP AND REMOVED THE TUBING. APPROPRIATE ANTIDOTES WERE GIVEN TO THE PT TO COUNTERACT THE MAGNESIUM SULFATE.
PT WAS BEING TRANSPORTED FROM SURGICAL SUITE TO ICU. ANESTHESIOLOGIST WAS AMBUING PT VIA ENDOTRACHEAL TUBE AND AMBU BAG DISCONNECTED/FELL APART AND UNABLE TO BE USED. ANOTHER HEALTH CARE PROVIDER RAN FOR AND RETRIEVED ANOTHER AMBU BAG FROM ICU. THEREFORE, PT DID NOT SUFFER HARM.
CAPSULECTOMY W/REMOVAL OF RUPTURED IMPLANTS. EXPLANTED 6/28/96.
THE PT WAS ADMITTED FOR SURGICAL REMOVAL OF A RUPTURED SILICONE BREAST IMPLANT (LEFT). THE RIGHT BREAST IMPLANT WAS REMOVED DUE TO THE AGE OF THE IMPLANT AND THE CAPSULAR CONTRACTURE.
PT WAS ADMITTED WITH A PREOPERATIVE DIAGNOSIS OF SEPSIS, INFECTED CENTRAL LINE. THE CENTRAL VENOUS CATHETER WAS SURGICALLY REMOVED FROM THE PT AND IT WAS DISCOVERED THAT THERE WAS A HOLE IN THE CATHETER THAT CONTRIBUTED TO THE INFECTION.
AS A TRANSVAGINAL HYSTERECTOMY WAS BEING COMPLETED, IT WAS NOTED A SMALL PIECE OF TENACULUM HAD BROKEN OFF AT SOME POINT DURING THE CASE. THE PIECE COULD NOT BE VISUALIZED SO A PELVIC X-RAY WAS OBTAINED WHICH WAS READ AS NEGATIVE.
EXPLANTED PENILE PROSTHESIS DUE TO FLUID LOSS. EXPLANTED 6/26/96.
AIDE WAS TRANSFERRING RESIDENT FROM BACK CHAIR INTO WHEELCHAIR WITH TRANSFER BELT ON. RESIDENT C/O PAIN IN LEG. NURSES AIDE NOTICED A LARGE GASH IN RIGHT LEG IN CALF AREA OF LEG. AREA WAS MEASURED AT 1.5 CM X .5 CM. AREA COVERED WITH STERILE DRESSING AND GAUZE WRAP. PRESSURE APPLIED FOR SOME BLEEDING. KEFLEX 250 MG FOR INFECTION. PT WAS TRANSFERRED TO HOSP FOR SEVERAL STITCHES IN AREA.
DURING REMOVAL OF VASCULAR ACCESS PORT IT WAS FOUND TO BE SHORTER THAN IT WAS AT TIME OF INSERTION. CXR REVEALED A PORTION OF THE CATHETER LODGED IN THE VENTRICLE OF THE HEART. THE CATHETER TIP WAS REMOVED BY RADIOLOGY WITH NO COMPLICATIONS. PT HAD COMPLETED CHEMOTHERAPY, PORT ACCESS NO LONGER NEEDED. IMPLANTED 2/20/96, EXPLANTED 5/23/96.
IN THE PROCESS OF CHANGING A TRIPLE LUMEN CATHETER TO A DIFFERENT TYPE CATHETER, THE TRIPLE LUMEN CATHETER WAS CUT BELOW THE ANCHOR TO THE SKIN TO ACHIEVE A MORE ASCEPTIC TECHNIQUE. THE CATHETER SLIPPED AND IT MIGRATED INTO THE RIGHT ATRIUM, REQUIRING REMOVAL IN THE CATHETERIZATION LAB. RETRIEVAL WAS SUCCESSFUL WITH NO UNTOWARD EFFECTS. CATHETER WAS NOT DEFECTIVE.
THE PT WAS ON A NEBULIZER HEATER FOR OXYGEN/HUMIDITY TO HIS TRACHEOSTOMY AND THE HEATER APPEARED TO SHORT-OUT AND A BURNED SPOT WAS NOTICED AT THE POWER SWITCH. IT WAS REMOVED FROM THE PT WITHOUT ANY PROBLEM.
A DARK SPECK WAS NOTED ON PHACO TIP BEFORE IT WAS INTRODUCED INTO THE EYE SO THE TIP WAS REPLACED WITH STERILE NEW TIP. AFTER PRIMING, SEVERAL DARK PIECES WERE FOUND IN THE IRRIGATION CONDOM. THE HANDPIECE AND TIP WERE REPLACED BEFORE SURGERY PROCEEDED. AFTER COMPLETION OF THE PHACO PORTION OF SURGERY, ON THE FOLLOWING CASE, SEVERAL FLECKS OF METALLIC APPEARING FRAGMENTS WERE NOTICED IN THE ANTERIOR CHAMBER OF THE EYE. THE SURGEON WAS ABLE TO REMOVE THE FRAGMENTS. THERE WERE NO VISIBLE FRAGMENTS NOTED AFTER IRRIGATION/ASPIRATION. VISIBLE MICROSCOPE OBSERVATIONS SUGGESTS SOME METAL FRAGMENTS COME FROM THE HANDPIECE. ALSO, DISCOLORATION SUGGESTS DOME DETERIORATION. FIVE METAL FRAGMENTS SENT FOR IDENTIFICATION.
A GLOVE WAS FOUND IN AN OPEN BOX WITH AN UNIDENTIFIED MATERIAL AND DISCOLORATION INSIDE THE GLOVE. THERE WAS NO PT PROBLEM OR EVIDENCE OF DISCOLORATION OF THE BOX. NO OTHER PROBLEM OF THIS NATURE WAS NOTED WITH OTHER GLOVES IN THE FACILITY.
SURGERY FOR REMOVAL OF RUPTURED SILICONE BREAST IMPLANTS.
PT WAS PULLING HIMSELF UP AND THE TRACTION BAR SNAPPED HITTING THE PT ON THE RIGHT UPPER LEG AND KNEE, HIT FOREARMS USED TO SHIELD HEAD.
CATHETER INSERTED IN ANTECUBITAL SITE. SUBSEQUENT TO INSERTION DEVICE BROKE AT THE HUB. MFR REP CONTACTED.
RPTR WAS TAKING A SHOWER WHEN SHE BENT OVER TO WASH HER LEGS. THE PLASTIC BACK CAME LOOSE. RPTR, WHO IS VERY SHORT COULD NOT REACH THE METAL FRAME TO WHICH THE PLASTIC BACK IS SUPPOSED TO BE ATTACHED. SHE QUICKLY GRABBED A SAFETY BAR IN HER BATHROOM TO KEEP FROM FALLING HEAD DOWN ON THE CONCRETE FLOOR. RPTR NOTICED THAT THERE ARE ONLY TWO SCREWS, WHICH LOOK LIKE WOOD SCREWS AND ARE VERY SMALL, HOLDING THE TOP PART OF THE PLASTIC TO THE METAL FRAME, SCREWS GO IN ABOUT 3/8" ONLY. THE BOTTOM PART OF THE PLASTIC DOES NOT HAVE ANY HOLES FOR THE SCREWS ON THE CORRESPONDING PART OF THE FRAME.
PT IS STATUS POST LEFT BREAST RECONSTRUCTION 8/7/92 WITH A 270CC SALINE IMPLANT WHICH RUPTURED SEVERAL WEEKS PRIOR TO 6/12/96. RUPTURED IMPLANT REPLACED 6/12/96.
BILATERAL SALINE FILLED BREAST IMPLANTS REMOVED BECAUSE OF DISPLACEMENT.
INFANT BOY DELIVERED AT 0837 AM ON 6/1/96. DELIVERY WAS COMPLICATED BY A PROLONGED SECOND STAGE. INFANT SUFFERED HEMORRHAGE BENEATH SCALP AT BIRTH. INFANT WAS ADMITTED TO NEONATAL INTENSIVE CARE UNIT AND WAS PLACED ON A VENTILATOR AT 1115AM. INFNAT EXPIRED AT 0830 AM ON 6/2/96 THE CAUSE OF DEATH WAS THE HEMORRHAGE. IT IS SPECULATED THAT HEMORRHAGE RESULTED FROM THE USE OF A VACUUM EXTRACTOR WITH DEFECTIVE GAUGE. GAUGE ON THE DEVICE REGISTERED IN THE GREEN "SAFE" ZONE EVEN THOUGH EXCESS VACUUM WAS BEING PRODUCED. THIS DEFECT WAS CONFIRMED BY TESTING THE DEVICE USING A PRESSURE TRANSDUCER. THERE WOULD HAVE BEEN NO WAY THE USER OF THE DEVICE WOULD HAVE KNOWN THAT THE GAUGE WAS DEFECTIVE AND THAT A DANGEROUS LEVEL OF VACUUM WAS BEING PRODUCED.
EIGHTY-EIGHT-YR-OLD MALE CARDIAC ARREST PT FOUND BY AED IN U-FIB. DEVICE DID NOT SHOCK ON 1ST & 2ND ASSESSMENT. 1:45 DELAY DEFIBRILLATING PT. SENT CASSETTE TAPE TO MFR 5/6/96, RETURNED 6/21/96. HOSP "NO CPR" DIRECTIVE.
UNABLE TO ATTACH DEFIBRILLATOR CABLE TO CASSETTE ATTEMPTED WITH THREE DIFFERENT SETS OF CABLES TWO DIFFERENT CRASH CARTS USED FOURTH SET OF CABLES SEATED PT WAS THEN DEFIBRILLATED THREE TIMES UNSUCCESSFULLY.
RPTR DEVELOPED SWOLLEN EYES, COUGHING, AND RASHES AROUND HER EYES. IT CONTINUED FROM 12/92 TO 8/95. SHE WAS EXPOSED TO LATEX AND DEVELOPED RASHES ON HER SKIN. ON 10/95, SHE DEVELOPED ASTHMA WHEN SHE WAS AROUND SOMEONE THAT WORE THE DEVICE. ON 11/13/95, SHE HAD A SIGNIFICANT ASTHMA ATTACK AND AN ANAPHYLACTIC REACTION. SHE WAS ACCIDENTALLY EXPOSED 2 OR 3 TIMES AFTER 11/95. ON 2/13/96 SHE WAS AGAIN ACCIDENTALLY EXPOSED AND HAD ANOTHER ATTACK AND SHE CONSIDERS THIS ATTACK AS UFE-THREATENING.
PT SUSTAINED TEAR OF PULMONARY ARTERY DURING DIAGNOSTIC HEART CATHETERIZATION. PT DEVELOPED DISTRESS FOLLOWING ATTEMPTS TO "WEDGE" CATHETER IN PULMONARY ARTERY. AUTOPSY REVEALED PT TO HAVE UNDERLYING DISEASE PLACING HER AT HIGH RISK FOR PULMONARY ARTERY RUPTURE. PT HAD SIGNIFICANT PULMONARY HYPERTENSION AND SEVERE ATHEROSCHLEROTIC DISEASE OF THE PULMONARY VASCULATURE.
BARD ACCESS SYSTEMS, INC. 5425 W AMELIA EARHART DR, SALT LAKE CITY, UT 84116. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND SO NO FAILURE ANALYSIS HAS BEEN DONE ON THE PRODUCT. AS NEITHER PRODUCT NUMBER NOR LOT NUMBER WERE AVAILABLE FOR THIS DEVICE, CO WAS UNABLE TO CONDUCT A DEVICE HISTORY REVIEW. CO HAS INSUFFICIENT INFO TO DETERMINE WHETHER OR NOT THE INCIDENT WAS ATTRIBUTABLE TO THE DEVICE. EXPECTED FREQUENCY: 4 INCIDENTS/YEAR, OBSERVED FREQUENCY: 3 INCIDENTS/YEAR.
WHEN THE CAROUSEL IS IMMEDIATELY LOADED TO MAXIMUM WITH 10 TEST CELLS (1 PT PER TEST CELL) THE CLOTTING TIME RESULTS GET LONGER AND LONGER DEPENDING ON THE LENGTH OF TIME THEY PRE-WARM (SIT ON THE CAROUSEL AT 37 DEGREES PRIOR TO ACTUAL TESTING). THIS LEADS TO ERRONEOUSLY HIGH PTT RESULTS ON THE SAMPLES IN THE TEST CELLS THAT ARE FROM THE MIDDLE TO THE END OF THIS FULL RUN. (*)
INFANT HAD INDWELLING CATHETER. LUERLOCK PORT ON LEFT SIDE OF Y CAME DISCONNECTED. ATTEMPTED TO REPAIR WITH BLUNT NEEDLE. UNABLE TO FIX BLUNT NEEDLE IN PORT, IN STABLE MANNER. LINE HAD TO BE DISCONNECTED. (LABEL)
RPTR WENT TO THE DR ON 12/95 AND THE DR TOLD HER THAT THE COATING WAS COMING OFF AND WOULD KILL HER RIGHT AWAY. SHE WAS NOT CONCERNED BECAUSE SHE WASN'T FEELING SICK. IN 3/96 SHE STARTED TO FEEL SICK. WHEN HER ARMS SWEAT, SHE FEELS LIKE THEY ARE BURING REALLY BAD, THAT'S WHEN SHE STARTED TO FIND MORE INFO ABOUT THE STIMULATOR. DR SAID THAT THE MAIN REASON THE SILICONE COATING CAME OFF, THE WIRE, WAS BECAUSE SHE SMOKES. SHE STATED "HOW CAN SOMETHING LIKE THIS BE APPROVED? I SMOKED FOR 20 YEARS AND HE NEVER ASKED ME ANYTHING." IN 12/95, DR WANTED PT TO SIGN A PAPER THAT STATED THAT SHE SHOULDN'T BE SMOKING." WHEN SHE ASKED HIM WHY, HE NEVER TOLD HER ANYTHING. HE SAID "WELL, I'M SORRY, I JUST ASSUMED YOU DIDN'T SMOKE." THE DEVICE IS MADE OF SILICONE "JUST LIKE BREAST IMPLANTS," AND SHE WANTS TO KNOW WHAT KIND OF TEST SHE NEEDS TO HAVE. SHE WENT TO A LAB AND THEY SAID THAT THEY DON'T DO ANY TEST FOR SILICONE. HER SYMPTOMS ARE "LIKE SOMEONE WHO HAS BREAST IMPLANTS."
PT FLIPPED LOUNGE CHAIR BY SHIFTING WEIGHT. CHAIR LANDED, SO BACK AND HEAD OF CHAIR WERE ON FLOOR. KNEES AND FEET POINTING UPWARDS. NO INJURIES NOTED.
RUPTURED BILATERAL IMPLANTS. UPON REMOVAL RIGHT SILICONE IMPLANT REMOVED INTACT, LEFT SILICONE IMPLANT RUPTURED.
INSERTION OF PERIPHERAL IV CATHETER. WITHIN 3-5 MIN SYSTEMIC RESPONSE ERYTHEMA, URTICARIA AND LARGE WHEALS, C/O HEAD AND NECK CONGESTION. RASH ALL OVER. SWELLING OF EARS, LIPS, ARMS WHICH SPREAD RAPIDLY. IMMEDIATELY REMOVED CATHETER. NOTIFIED DR. RX BENADRYL 50MG IV (2 DOSES) AT 1525 AND 1900 HRS AND L2 BY CANNULAE. DISCHARGED NEXT DAY 7/3/96 AT 0930 - SKIN CLEAR.
WHEN RPTR PUSHES THE FORWARD CONTROL, SOMETIMES IT LOCKS AND TO DISLODGE IT SHE HAS TO PUSH IT BACKWARDS. SHE CAN ONLY USE HER LEFT HAND. SHE STATED "IT IS HARD FOR ME TO PUSH IT BACKWARDS TO STOP IT."
PUMP PROGRAMMED TO GIVE AN ANTIBIOTIC (IN THE HOME) X 5 DAYS. THE PUMP WENT TO "OFF" POSITION AND STOPPED WORKING. THE PT CALLED - A NURSE WENT OUT, THE PUMP WAS REPLACED WITH A NEW ONE, THE PT MISSED NO DOSES OF MEDICATION. THE MFR WAS NOTIFIED AND THE PUMP WAS SENT BACK FOR REVIEW AND TESTING.
PERFORMED ABG ON PT, REMOVED NEEDLE AND CAPPED SYRINGE WITH FILTER. PROCEEDED TO REMOVE AIR BUBBLE BY PRESSING PLUNGER WHEN BLOOD SQUIRTED DIRECTLY INTO FACE AND INTO LEFT EYE. AFTER INCIDENT, FOUND SMALL HOLE IN SYRINGE.
THE COMPLAINANT WAS OPERATING A POWER DRIVEN WHEELCHAIR AND A RETAINING CLIP FELL OFF THE WHEELCHAIR. THE COMPLAINANT SUSTAINED INJURIES. RPTR WAS ADVISED THAT THE WRONG CLIP WAS USED ON THE DEVICE.
PT WAS IN ATRIAL FLUTTER. HE WAS CARDIOVERTED AT 200 AND 300 JOULES. AFTER CARDIOVERSION, PT HAD BURNED AREA OVER LEFT CHEST WHERE ELECTRODES CONTACTED SKIN.
CONSUMER REPORTED THAT SHE PURCHASED THE WHEELCHAIR/SCOOTER IN 3/96. RECENTLY, THE ARM BROKE OFF AND THE MFR TOLD HER THAT IT WOULD TAKE 8 DAYS TO SHIP A NEW CHAIR TO HER. SHE COULD NOT BE WITHOUT THE CHAIR FOR THAT LONG SO SHE TOOK IT TO A LOCAL CO AND HAD THE ARM WELDED BACK ON. THE WELDER TOLD HER THAT IT WAS "INFERIOR MATERIAL" AND WOULD BREAK OFF AGAIN.
A FIXATION PIN HEAD WAS REMOVED FROM THE FRAME AND WAS DISCOVERED BY THE HOSP TO HAVE THE TIP CHIPPED OFF. THE HOSP COULD NOT DETERMINE IF THIS HAPPENED BEFORE, DURING, OR AFTER THE PROCEDURE. IT WAS LEARNED ON 6/6/96 THAT THE PT WILL UNDERGO MRI AT THEIR CHECK UP TO CHECK FOR ANY POSSIBLE DEBRIS. CO DID NOT WANT TO WAIT FOR THE RESULTS TO DETERMINE IF AN MDR IS NEEDED.
PT WAS COMPLAINING OF PAIN. DR DIAGNOSED SYNOVITIS AND REMOVED BLACK POLY INSERT AND A POROUS PATELLA IMPLANT THAT SHOWED WEAR. REPLACED WITH ALL POLY PATELLA AND A POLY INSERT.
WHILE PERFORMING A TOTAL HIP REPLACEMENT PROCEDURE, THE STEM WOULD NOT SEAT COMPLETELY, BEFORE THE STEM COULD BE REMOVED, THE CEMENT SET UP. A REVISION TOTAL HIP PROCEDURE HAD TO BE PERFORMED AFTER REMOVING THE STEM, IN ORDER TO REMOVE THE STEM A DISTAL WINDOW HAD TO BE MADE IN THE FEMUR.
CEMENT HARDENED BEFORE SURGEON COULD COMPLETE PROCEDURE REQUIRING EXTENDED OR TIME TO CORRECT. ADD'L BONE CEMENT USED.
PT WAS BEING TREATED FOR WILM'S TUMOR. WHEN THE NURSE TURNED THE PT, NOTICED THE CATHETER WAS LEAKING WHERE THE Y CONNECTOR MEETS THE CATHETER SHAFT. THEY WERE ABLE TO DEFLATE THE BALLOON AND REMOVE THE CATHETER WITHOUT INJURY TO THE PT. PRODUCT WILL NOT BE RETURNED FOR MFR'S EVALUATION.
CUSTOMER REPORTS AIRWAY PRESSURE MONITOR DID NOT ALARM DURING A PT DISCONNECT. DELAY SETTING WAS AT 20 SECS. PT WAS DISCOVERED IN A HYPOXIC, CYANOTIC CONDITION BEFORE DISCONNECT WAS FOUND. PT CIRCUIT WAS RECONNECTED AND AIRWAY PRESSURE MONITOR REPLACED. SYSTEM THEN CHECKED OKAY. NO FURTHER PROPLEMS NOTED.
THE DEVICE WAS USED IN LAPAROSCOPIC SALPINGECTOMY (ECTOPIC) PROCEDURE. THE DEVICE WAS THE THIRD TROCAR PLACED DURING THE PROCEDURE. THE TROCAR WAS PLACED INTO THE ABDOMEN BY A FIRST YEAR RESIDENT. THE PLACEMENT WAS OBSERVED UNDER DIRECT ENDOSCOPIC VISION. AS THE TIP ENTERED THE ABDOMINAL CAVITY THE SHIELD WAS OBSERVED FUNCTIONING RPOPERLY, ADVANCING OVER THE BLADE. THE RESIDENT THEN CONTINUED TO INSERT THE TROCAR BEYOND THE FIELD OF VIEW OF THE CAMERA. THE INSERTION CONTINUED THE FULL LENGTH OF THE 100 MM CANNULA. THE PROCEDURE WAS FINISHED UNEVENTFULLY AND THE PT WAS RELEASED TO POST-OP RECOVERY. APPROX FOUR HRS LATER, THE PTS VITAL SIGNS DROPPED. THE PT WAS RUSHED TO SURGERY FOR AN EXPLORATORY LAPAROTOMY WHERE A 1 CM LACERATION AT THE BIFURCATION OF THE COMMON ILIAC AND EXTERNAL ILIAC ARTERIES WAS FOUND. FURTHER EXPLORATION FOUND A SMALL LACERATION ON THE ILIAC VEIN. BOTH WERE REPAIRED AND THE PT WAS REPORTED AS STABLE. THE TROCAR IN QUESTION HAS BEEN RETURNED BY THE HOSP AND HAS BEEN EVALUATED FOR PROPER SHIELD MOVEMENT AND OVERALL CONDITION. BASED ON CO'S EVALUATION, THE PRODUCT IS IN PROPER WORKING ORDER. THE PRODUCT HAS BEEN FORWARDED TO THE MFR FOR A COMPLETE EVALUATION.
APPROX 15 MIN INTO THE PT'S TREATMENT THE PT BEGAN TO C/O BACK AND MIDSTERNAL PAIN. THE PT WAS TAKEN OFF THE MACHINE FOR 15 MIN AND THE BLOOD WAS RECIRCULATED. TREATMENT WAS RESUMED USING THE SAME DIALYZER WITHOUT FURTHER INCIDENT. THE NURSE STATED THAT THE PT HAD A DIALYZER HYPERSENSITIVITY REACTION.
ONE OF THEIR PT'S RECEIVED 3 HRS 45 MIN OF HEMODIALYSIS TREATMENT AND WAS SENT HOME WITHOUT ANY COMPLAINTS. THAT SAME DAY THE FACILITY RECEIVED A PHONE CALL FROM THE PT'S WIFE WHO STATED THAT HER HUSBAND FELT SICK TO HIS STOMACH. THE PT WENT BACK TO THE FACILITY FOR EVALUATION AND THEN SENT TO THE HOSP WHERE HEMOLYSIS WAS IDENTIFIED. DURING HOSPITALIZATION THE PT RECEIVED 4 UNITS OF BLOOD. THE SAMPLE WAS DISCARDED.
PT HAD VAGUE C/O CHEST PAIN RADIATING TO BACK AND SHOULDERS AFTER INITATION OF DIALYSIS. DIALYSIS WAS STOPPED AND THE SETUP WAS PUT INTO RECURCULATION, UNTIL THE MD WAS NOTIFIED. DIALYSIS WAS RESTARTED 15 MIN LATER WITH THE SAME DIALYZER WITHOUT FURTHER INCIDENT. SAMPLE WAS DISCARDED BY THE FACILITY.
PATELLA SPLIT IN HALF AND THE PATELLA COMPONENT SEPARATED FROM THE PATELLA.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TIBIAL INSERT SHOWED SIGNS OF WEAR AND WAS TAKEN OUT WITH PATELLA.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHILE WEARING HYPOALLERGENIC LATEX EXAM GLOVES, TWO NURSES EXPERIENCED EYES SWELLING, ITCHING, REDNESS, AND BREATHING CONCERNS. ONE NURSE TOOK BENADRYL. UNKNOWN IF MEDICAL TREATMENT WAS REQUIRED FOR OTHER NURSE. DERMAL SENSITIZATION STUDIES ON FILE AT CO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHILE CARRYING A SHARPS CONTAINER, NURSE WAS STUCK ON SIDE OF ABDOMEN BY NEEDLE THAT POKED THROUGH THE CORNER OF THE CONTAINER. NURSE WENT FOR HIV TESTING.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT'S KNEE WAS REVISED ON 4/8/94. ALL NEW COMPONENTS WERE PUT IN, ORIGINAL SURGERY WAS DONE ON 4/12/92. IN BOTH INSTANCES THE TIBIAL INSERT FAILED MISERABLY. THE HOSP MUST BE CREDITED FOR THE IMPLANT DUE TO IT'S EARLY FAILURE. TIBIAL INSERT DELAMINATED AND FRACTURED ON THE MEDIAL SIDE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SURGEON COULDN'T GET THE INSERT TO SEAT ON THE TIBIAL BASEPLATE. HE HAD EXCELLENT EXPOSURE OF THE BASEPLATE. THE INSERT WOULD ROCK BACK AND FORTH WHILE THE SURGEON PLACED THE KNEE THROUGH RANGE OF MOTION. THE PT WAS NOT CHARGED FOR THIS COMPONENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PA AND LATERAL VIEWS OF THE CHEST AND OVERHEAD AS WELL AS VIDEO. FLUOROSCOPIC AND SPOT FILM EVALUATION WERE PERFORMED. THERE IS A FRACTURE IN THE DISTAL ASPECT OF TEH ATRIAL "J" WIRE WITH 2 CM EXTENDING BEYOND THE SHEATH. THERE IS NO EVIDENCE OF SEPARATED EXTRUDED ADD'L SEGMENT. FRACTURE OF THE DISTAL ATRIAL LEAD WITH RETENSION WIRE EXTENDING BEYOND THE SHEATH AS DESCRIBED ABOVE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULOTOMIES.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
RIGHT BREAST IMPLANT EXCHANGE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULOTOMY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE WITH BILATERAL CAPSULECTOMY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE OF RIGHT BREAST IMPLANT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL CAPSULECTOMIES WITH EXCHANGE OF IMPLANTS.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL IMPLANT EXCHANGE WITH CAPSULECTOMIES.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL IMPLANT EXCHANGE AND CAPSULOTOMYDEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
RUPTURED BREAST IMPLANTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  OTHER.  CONCLUSION:  OTHER.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE CUSTOMER REPORTED THAT THE UNIT WAS PLUGGED INTO AC POWER AND TURNED ON. THE UNIT SHORTED OUT WITH SPAARKS COMING OUT OF IT. NO PT INJURY OCCURRED.
THIS DISTRIBUTOR BECAME AWARE OF AN EVENT THAT OCCURRED INVOLVING A GUIDEWIRE. IT WAS USED THROUGH AN ENTRY NEEDLE AND LEFT RENAL ARTERY CATHERIZATION WAS PERFORMED SUCCESSFULLY. DURING A FOLLOW UP ANGIOGRAM A PIECE OF THE WIRE COATING WAS NOTED IN THE RIGHT RENAL VEIN. A RETRIEVAL BASKET WAS THEN ADVANCED AND SUCCESSFULLY RETRIEVED THE SEGMENT OF COATING. THE PT EXPERIENCED NO SEQUELAE AS A RESULT OF THIS EVENT. THE DIRECTIONS FOR USE FOR THIS PRODUCT STATE: "TO AVOID DAMAGE AND POSSIBLE SHEARING OF PLASTIC, DO NOT WITHDRAW OR MANIPULATE THROUGH A METAL CANNULA/METAL DILATOR. EXTREME CAUTION SHOULD BE OBSERVED WHEN USED WITH A ONEWALL PUNCTURE STYLE NEEDLE.
PT UNDERWENT SURGICAL PROCEDURE REQUIRING DRAINAGE DEVICE. UPON ORDERED REMOVAL OF DRAINAGE DEVICE, DRAIN BROKE. PART OF DRAINAGE DEVICE RETAINED IN PT'S ABDOMEN, REQUIRING SURGICAL INTERVENTION FOR REMOVAL. AT THE TIME OF REMOVAL, IT WAS NOT DISCOVERED THAT PART OF THE DRAIN WAS RETAINED.
PATELLA COMPONENT DELAMINATED. SWITCHED FROM BLACK POLY TO WHITE POLY.
IMPLANT DATE: 12/88. PT FELL DURING NORMAL ACTIVITY AND PATELLA WAS SHEARED.
A MALE PT IMPLANTED ON 4/16/96 WITH SPINE SYSTEM BONE SCREWS UNDERWENT A SURGICAL REVISION ON 4/30/96 AFTER THE PHYSICIAN NOTED ON 4/25/96 THAT ONE OF THE SCREWS APPEARED TO BE BACKING OUT OF THE SPINE. THE PHYSICIAN INDICATED THAT THE BONE SCREWS WERE EXPLANTED AND REPLACED. NO COMPLICATIONS WERE OBSERVED POST-OP. THE PT WILL CONTINUE TO BE FOLLOWED BY THE PHYSICIAN.
CLINIC SET-UP/OUT PT SETUP DONE ACCORDING TO TOLERATE LEVEL. PT AT THAT TIME HAD NO COMPLAINT OF PAIN DURING TREATMENT. LATER, PT COMPLAINED OF WRIST PAIN, STATING THE MACHINE JERKED TO SIDE. PT WAS SEEN BY PHYSICIAN. RESULT OF ALLEGED INCIDENT WAS PAIN AND SWELLING OF WRIST. DUE TO JERKING MOTION TO THE SIDE OF PT'S WRIST. PHYSICIAN THEREFORE PRESCRIBED PARAFIN BATH.
APPROX. ONE  WEEK AFTER PERFORMING A TOTAL KNEE PROCEDURE USING CEMENT, THE SURGEON HAD TO RE-OPERATE AND REPLACE THE TOTAL KNEE TIBIAL TRAY AND TIBIAL SURFACE DUE TO LOSS OF BONDING BETWEEN THE BONE CEMENT AND TIBIAL TRAY.
PT'S SON REPORTED THAT ON THE FIRST EXCHANGE THE PT COMPLAINED OF EXTREME PAIN AND NOT BEING ABLE TO BREATHE. THE PT WAS TAKEN TO THE EMERGENCY ROOM AND THEY DRAINED OUT 5000ML OF SOLUTION FROM HER.
PT MOVED FROM REDINESS CHAIR TO WHEELCHAIR TO PULL NEEDLES AFTER DIALYSIS RUN. PT MOVING ARM AND TALKING WITH OTHER NURSE, WHEN APPROX 50CC BLOOD NOTED IN CHAIR, WITH CLAMP TO NEEDLE OPEN. CLAMPS HAD BEEN CLAMPED PRIOR TO THIS.
PT HAD PORT INSERTED 4/22/96 FOR CHEMO THERAPY. PORT FUNCTIONING WELL UNTIL 1 WK AGO. PT SCHEDULED FOR REMOVAL OF PORT ON 7/2/96. CATHETER NOT FOUND TO BE ATTACHED TO PORT. INCISION CLOSED - X-RAYS OBTAINED. PT SENT TO SPECIAL PROCEDURE FOR REMOVAL OF CATHETER VIA FEMORAL VEIN.
PT WAS ADMITTED TO CATH LAB FOR A PERCUTANEOUS NEPHROSTOLITHOTOMY TO RETRIEVE A LARGE RENAL CALCULUS AND WAS PLACED UNDER GENERAL ANESTHESIA. THE DR COMPLETED THE CYSTOSCOPY, REMOVAL OF THE URETERAL STENT, AND PERFORMED A LEFT RETROGRADE PYELOGRAM, WHICH REVEALED A LARGE RENAL PELVIS WITH TWO LARGE CALCULI LODGED IN THE LOWER POLE. PT TURNED AND REPOSITIONED. ATTEMPTS TO PERFORM THE PERCUTANEOUS NEPHROSTOLITHOTOMY WERE UNSUCCESSFUL DUE TO POOR IMAGING, DUE TO THE X-RAY FLUORO SCAN MACHINE SHOWING SIGNIFICANT PIVELATION.
PORT WAS ACCESSED WITH 19G X 3/4 IN HUBER NEEDLE. NEEDLE FLUSHED WITH NORMAL SALINE PER PROTOCOL. AFTER PORT HAD BEEN ACCESSED, THE NURSE WAS UNABLE TO ASPIRATE OR FLUSH THE PORT. THIS OCCURRED WITH 2 NEEDLES. A DIFFERENT NEEDLE WAS USED AND IT WAS DETERMINED BY THE NURSE THAT IT WAS THE CO'S HUBER NEEDLE, NOT THE PORT THAT FAILED. REMAINING NEEDLES FROM THE LOT RETURNED TO PURCHASING.
PT WAS TAKEN TO A MEDICAL CENTER. PARENTS STATED THAT WHILE TAKING RECTAL TEMPERATURE, THE RECTAL THERMOMETER BROKE OFF AT THE EEND OF THE BULB INTO THE PT'S RECTUM.
WHILE PROCESSING THE FIRST 200 ML OF BLOOD THE PRODUCT BOWL EXPLODED. THE 200 ML WAS EXPELLED AT HIGH VELOCITY, CONTAMINATING THE MACHINE, THE OPERATOR, AND ALL EQUIPMENT IN CLOSE PROXIMITY. THE BOWL WAS CHANGED OUT AND A NEW MACHINE WAS BROUGHT IN.
WHEN IN USE ON A PT RECEIVING GENERAL ENDOTRACHEAL ANESTHESIA, ON SEVERAL OCCASIONS THE VENTILATOR BELLOWS FAILED TO RISE. AFTER SEVERAL ATTEMPTS TO DETERMINE THE CAUSE OF THE FAILURE, THE VENTILATOR AGAIN BEGAN TO WORK. NO OBVIOUS REASON FOR THE FAILURE WAS FOUND.
REMOVED INFECTED RIGHT BREAST IMPLANT. ORIGINALLY PLACED ON 12/93 AT ANOTHER HOSP. PT HAD A REVISION ON 4/94, AND HAS BEEN INFECTED AT LEAST SINCE 1/95 WHEN DR STARTED CARING FOR HER.
DURING A PROCEDURE TO REMOVE A URETERAL STONE, THE BASKET BROKE. THIS NECESSITATED A SECOND PROCEDURE TO BE PERFORMED AND EXTENDED THE PT'S HOSP STAY BY 2 DAYS.
WHILE APPLYING STAPLES TO THE CYSTIC DUCT DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE STAPLE LIGATED THE CYSTIC DUCT. PROXIMAL DUCT WAS RELOCATED AND STAPLED.
CELL SAVER WAS BEING USED IN THE "FILL" MODE. AFTER PROCESSING APPROX 1.5 LITERS THERE WAS AN ACUTE AND TOTAL FAILURE OF THE BOWL. THE BOWL FRACTURED AND SPRAYED THE ENTIRE CONTENTS (250 CC) OUT OF THE SYSTEM, COVERING THE OPERATOR, THE DISPOSABLE COMPONENTS AND THE MACHINE. EQUIPMENT WAS CHANGED WITHOUT FURTHER INCIDENT.
FOLLOWING STANDARD PROCEDURES THE EPIDURAL CATHETER WAS INTRODUCED THROUGH A "T" NEEDLE AT THE L3-L4 LEVEL. EPIDURAL VEIN WAS ENCOUNTERED. PHYSICIAN ATTEMPTED TO WITHDRAW THE CATHETER AND NEEDLE SIMULTANEOUSLY BUT WAS UNABLE TO DUE TO TIGHTNESS OF THE LIGAMENTS AND 2.7 CM OF THE CATHETER WAS SHORN OFF AND REMAINS IN THE EPIDURAL SPACE. PT CONTINUES TO BY ASYMPTOMATIC AS OF THIRD POSTOPERATIVE DAY.
PT BEGAN TO C/O BURNING PAIN AND GREATER SIZED RED AREAS APPEARED ON LEGS. NO EVIDENCE OF BLISTERS. PAIN AND REDNESS LATER SUBSIDED. (USER ERROR).
BASKET RETRIEVAL DEVICE DID NOT GO UP THE SECOND TIME.
RESIDENT FELT WEAK WHILE BEING MOVED FROM CHAIR TO BED VIA LIFT. THE TWO STAFF MEMBERS WHO WERE TRANSFERRING RESIDENT WERE UNABLE TO PREVENT RESIDENT FROM SLIDING OUT OF SLING SO THEY LOWERED HER TO THE FLOOR. RESIDENT HAD X-RAY ON THE FOLLOWING DAY WHICH REVEALED A FRACTURE OF RIGHT DISTAL FEMUR. STAFF WAS ALERTED TO POSSIBILITY OF PROBLEM WITH LIFT OR LIFT BELT ON 7/10/96. THE LIFT WAS PURCHASED IN 11/95 AND WAS PUT TOGETHER BY STAFF FROM THIS FACILITY. UNSURE AS TO THE INSTRUCTIONS THAT CAME WITH LIFT RE-ASSEMBLY. NO INSTRUCTION ON THREADING BELT THROUGH SNAP-TOGETHER LOCKING DEVICE. TEETH ON ONE SIDE ONLY. WHEN LIFT WAS INSPECTED ON 7/10/96, THE WAIST BELT OF THE LIFT WAS NOT HOLDING IN A LOCKING POSITION. NEW BELTS ORDERED AND APPLIED - DISCOVERED THAT BELT NOT APPLIED CORRECTLY VERSUS BEING DEFECTIVE. THIS WAS ALSO TRUE OF ANOTHER LIFT IN FACILITY.
REMOVAL OF AN ARTERIAL SHEATH IN THE LEFT GROIN CAUSED THE PT TO HEMORRHAGE. UPON REMOVAL OF THE SHEATH IT WAS DISCOVERED THAT THE SHEATH HAD SEPARATED INTO TWO PIECES. THE SECOND PIECE WAS REMOVED WITHOUT INCIDENT. THE PT WAS DISCHARGED THE FOLLOWING MORNING WITH NO RESIDUAL PROBLEMS OR COMPLICATIONS.
PT WAS UNDERGOING A CORONARY BY-PASS. THE INLET PORT ON THE CENTRIFUGAL PUMP HEAD CONE SEPARATED FROM THE REST OF THE COMPONENT. INLET AND OUTLET LINES WERE IMMEDIATELY CLAMPED. THE CONE WAS REPLACED AND BLOOD FLOW RESTORED. APPROX TIME WAS 2-3 MINS. POST-OP LAB TESTS SHOWED ALL FUNCTIONS AS NORMAL. PT EXPIRED APPROX 48 HRS LATER.
CENTRAL VENOUS CATHETER (PICC-LINE) BECAME IMMOBILIZED FROM THE ARM ANT THE DISTAL PORTION MIGRATED INTO THE DISTAL PULMONARY OUTFLOW TRACT.
A POST SURGICAL PT ON A NURSING FLOOR WAS RECEIVING A CONTINUOUS EPIDURAL INFUSION IF FETANYL AND BUPIVICAINE AT A RATE OF 6CC PER HOUR THROUGH AN I.V. PUMP. A NEW 100CC MINIBAG WAS HUNG AT 4:30 PM WITHOUT CHANGING THE PUMP SET OR MAKING ANY CHANGES TO THE SETTINGS ON THE PUMP. THE PT WAS SEEN BY NURSING AT 5:10 PM AND NOTHING OUT OF THE ORDINARY WAS SEEN. AT 5:25 PM THE PT WAS FOUND UNRESPONSIVE WITH DECREASED RESPIRATIONS. THE MINIBAG WAS EMPTY. THE PT WAS SUCCESSFULLY RESUSCITATED AND, AS OF 6/24/96, THE PT EXHIBITS NO HARMFUL EFFECTS. THE PUMP SHOWED NO OBVIOUS PROBLEMS AND SUBSEQUENT FLOW RATE TESTS BY BIOMEDICAL DID NOT SHOW ANY DEVIATION FROM NORMAL OPERATIONS. AT 2:30 PM (SHIFT CHANGE) THE VOLUME INFUSED SETTING WAS RESET TO 0. AT 5:25 PM WHEN THE PUMP WAS REMOVED IT SHOWED 21.5CC HAD BEEN INFUSED. THE PUMP'S INTERNAL ERROR MEMORY SHOWED ERRORS THE DAY BEFORE (6/18/96) AND FROM BIOMEDICALS TESTING BUT NO ERROR MESSAGES FROM THE DAY OF THE EVENT.
PT UNDERGOING LEFT KNEE SURGERY. WHILE USING THE HOOK KNIFE IN THE PT'S LEFT KNEE, THE INSTRUMENT BROKE INTO 3 PIECES. TWO (2) PIECES WERE IN PT'S KNEE, AND THE DR REMOVED THEM AND PROCEEDED WITH THE PROCEDURE. NO APPARENT RESIDUAL NEGATIVE OUTCOME TO PT.
UNABLE TO DRAW BLOOD FROM PORT. CHEST X-RAY DEMONSTRATED FRACTURE OF THE CENTRAL LINE UNDER THE CLAVICLE. SURGICAL PROCEDURE DONE 4/20 TO RETRIEVE THE INTRAVASCULAR FOREIGN BODY.
CATHETER SEPARATED PARTIALLY FROM HUB FOLLOWING INSERTION, ALLOWING BLOOD LEAKAGE. THIS IS THE THIRD EVENT OF THIS TYPE RECENTLY.
DURING PTCA, A STENT WAS ADVANCED INTO THE DISTAL RIGHT CORONARY ARTERY. IT COULD NOT BE ENGAGED INTO THE STENOSIS. WHEN THE STENT WAS REMOVED, IT WAS NOTED THAT THE STENT WAS NO LONGER DEPLOYED ON THE BALLOON PORTION. IT IS PRESUMED THAT THE STENT WAS EMBOLIZED SOMEWHERE IN THE ARTERIAL SYSTEM.
CATHETER SEPARATED FROM HUB FOLLOWING INSERTION ALLOWING BLOOD LEAKAGE. THE FIRST TWO CATHETERS WERE NOT RETAINED. THERE WERE NO PERMANENT SEQUELAE AS A RESULT OF ANY OF THE INCIDENTS.
WHILE TRANSFERRING RESIDENT FROM THE SHOWER CHAIR TO A STANDING POSITION  USING THE PT LIFT, RESIDENT SUSTAINED DEEP PUNCTURE WOUNDS TO THE RIGHT AND LEFT LEGS, AT THE SHIN AREAS.
RESIDENT WAS BEING TRANSFERRED FROM BED TO WHEELCHAIR BY TWO ASSISTANTS USING THE LIFT. WHILE TURNING, THE LIFT BASE CLOSED, THE FRONT RIGHT WHEEL LIFTED 1/4 INCH OFF THE FLOOR AND THE LIFT TIPPED OVER, CAUSING THE RESIDENT TO FALL TO THE FLOOR. THE RESIDENT LANDED ON HER BUTTOCKS AND RIGHT HIP. INVESTIGATION OF ENVIRONMENT REVEALED THE FLOOR WAS CLEAN AND DRY. 5/17/96 X-RAY OF RIGHT HIP. ACUTE FEMORAL NECK FRACTURE. TREATMENT OF OSTEOPOROSIS.
CABG DONE. PT IN BYPASS. OXYGENATOR IN USE. LEAKING INTO GAS FILTER NOTICED. UNIT FUNCTIONED PROPERLY. NO ADVERSE OUTCOME.
WHILE USING PRODUCT DURING LAPROSCOPIC SPLENECTOMY, A HOLE WAS MADE IN DEVICE AND SMALL BOWEL WAS INJURED. THIS NECESSITATED A LAPAROTOMY AND A SMALL BOWEL RESECTION WITH REANASTOMOSIS.
PT HAVING OPEN HEART SURGERY. ON BYPASS. OXYGENATOR IN USE. LOW 02 FLOWS NOTED. ADJUSTMENTS MADE. NEW OXYGENATOR NEEDED. PT STABLE.
A 50-YR-OLD FEMALE WITH 2-3 MONTH HISTORY OF R BREAST NODULE; UPPER OUTER QUADRANT. PT HAD RIGHT RUPTURED SILICONE BREAST IMPLANT REMOVED.
INABILITY TO REMOVE CATHETER IN THE RIGHT GROIN. DURING CARDIAC CATH. "THERE IS AN ANOMALOUS LEFT CORONARY ARTERY WHICH COULD NOT BE CANNULATED DESPITE NUMEROUS ATTEMPTS." WHILE TRYING TO CANNULATE THIS THE CATHETER BECAME KNOTTED. THE CATHETER WAS BROUGHT BACK TO THE SHEATH BUT COULD NOT BE BROUGHT BACK OUT OF THE SHEATH. ATTEMPTS WERE MADE TO OPEN THE CATHETER BUT THIS DID NOT WORK. THE PT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL. THE PT TOLERATED THE PROCEDURE WELL.
WHEN TUBE WAS BEING REMOVED, TUBE FRACTURED LEAVING MUSHROOM END IN STOMACH. PT REQUIRED EMERGENT ENDOSCOPY. NO FURTHER PROBLEM KNOWN.
WITHIN 15 TO 30 SECONDS OF DESFLURANE VAPORIZER BEING SET AT 18%, AGENT ANALYZER INDICATED GREATER THAN 14%. AFTER TURNING OFF VAPORIZER, ADD'L ATTEMPTS AT DELIVERING 3-6% DESFLURANE LED TO FURTHER LARGE 10-14% CONCENTRATIONS DETECTED IN CIRCUIT. VAPORIZER REMOVED ISOFLURANE ADMINISTERED, NEW VAPORIZER INSTALLED AND VERIFIED ON AGENT MONITOR.
DURING LAPAROSCOPIC ASPIRATION OF A RIGHT OVARIAN CYST, THE NEEDLE BROKE OFF THE HOLDER. THE NEEDLE WAS SUBSEQUENTLY RECOVERED FROM THE PT'S ABDOMEN.
WHEN ATTEMPTING TO REMOVE PICC CATHETER, OBSTRUCTION WAS ENCOUNTERED WITH APPROX 8 CM REMAINING IN PT. FOLLOWING NUMEROUS ATTEMPTS, CATHETER AND APPROX 6 IN CLOT WAS REMOVED WITH A BASKET BY AN INTERVENTINAL RADIOLOGIST.
RESIDENT UNABLE TO EXPLAIN DUE TO SPEAKING POLISH. CNA REPORTS SHE HAD COMPLETED GIVING RESIDENT A BATH AND WAS TURNING THE TUB LIFT CHAIR WHEN RESIDENT'S FOOT LIGHTLY TAPPED W/C, WHICH HAD BEEN POSITIONED AT FOOT OF TUB. RESIDENT EBGAN TO HOLLER AND WIGGLE AND SLIDE DOWN FROM CHAIR AND FALL FOWARD FROM CHAIR LANDING ON RIGHT SIDE OF BODY. RESIDENT ASSESSED AT SITE. TOP OF HEAD RESTING ON WALL. ALERT, PUPILS EQUAL, SKIN WARM AND DRY LAYING ON RIGHT SIDE IN FETAL POSITION. UNABLE TO ASCERTAIN EXTENT OF INJURIES AS RESIDENT REFUSED TO MOVE AND YELLED OUT WHEN LEFT KNEE TOUCHED. NO VISIBLE WOUNDS NOTED, SEVERAL DROPS OF BLOOD NOTED ON FLOOR, POSSIBLY FROM RLE, TRANSFERRED TO BACKBOARD MAINTAINING FETAL POSITION. TRANSFERRED TO HOSP ER.
WHILE TIGHTENING HARDWARE, TIP OF HEX SCREWDRIVER FRACTURED. DESPITE ATTEMPTS TO REMOVE IT, THE TIP REMAINS IMBEDDED IN THE HARDWARE IMPLANTED IN THE PT.
PLASTIC EXTENSION ON LARYNGOSCOPE FELL OFF DURING ANESTHESIA AND WAS DISCOVERED WHEN THE PT WAS TRANSFERRED TO THE RECOVERY AREA. PT SUFFERED SOME SORENESS OF THE THROAT FOR 24 HRS BUT SUBSEQUENTLY RECOVERED WITHOUT ADD'L PROBLEMS.
WHEN LIFTING RESIDENT OUT OF W.P. WASHER, BELT BENT RELEASING SAFETY BELT, ON LIFTING CAUSING RESIDENT TO FALL OUT OF WP LIFT CHAIR. RESULTED IN LEFT LEG FRACTURE.
AT THE TIME OF SURGERY, IT WAS FOUND THAT THE PROSTHESIS WAS DEFECTIVE IN THAT THE TUBING FROM ONE OF THE CYLINDERS HAD BECOME DISCONNECTED FROM THE SCROTAL RESERVOIR/PUMP.
UPON ATTEMPTED REMOVAL, THE CATHETER CAME PART OF THE WAY OUT OF THE VEIN AND THEN SEEMED OBSTRUCTED. PT WAS THEN SEEN BY INTERVENTIONAL RADIOLOGY. A 4 CM SECTION APPEARED TO BE RETAINED IN THE VEIN, SURROUNDED BY THROMBUS. CATHETER WAS SUCCESSFULLY REMOVED FROM THE VEIN WITHOUT NEED FOR A CUTDOWN. PT HAS SINCE BEEN DISCHARGED WITHOUT FURTHER COMPLICATIONS.
PT COMPLAINED THAT STENT COULD NOT BE FLUSHED. UNDER FLUOROSCOPIC EXAMINATION IT BECAME APPARENT THAT THE NEPHROURETERAL STENT HAD FRACTURED AT THE POINT OF THE 5 FR STENT, WITH 20 CM OF THE STENT REMAINING IN THE PT.
AT APPROX. 1730 ON 5/29/96, PT FOUND IN BATHTUB BY MOTHER APNEIC AND CYANOTIC. CODE BLUE CALLED. NARCAN GIVEN. PT HAD IV FENTANYL INFUSING BY SYRINGE PUMP AT THE RATE OF 1.2CC/HR. THE NURSE HAD PLACED A 60 SYRINGE IN THE PUMP, WITH 40CC OF FETANYL (2000 MCG) TO INFUSE OVER 24 HRS AT THE RATE OF 1.2CC 1HR. THE NEW SYRINGE WAS PLACED IN THE SYRINGE PUMP, ONE HOUR PRIOR TO THE EVENT. AFTER THE PT WAS STABILIAZED IT WAS NOTED THAT THE SYRINGE WAS EMPTY AND THE PUMP HAD NOT ALARMED WHILE ON BATTERY. PT HAS CHRONIC M. LEUKEMIA AND IS IN PAIN. PT HAD PREVIOUSLY REQUESTED BOLUSES OF PAIN MEDICATION. PT WAS ALONE IN THE BATHROOM WHEN THIS OCCURRED.
THE PT RECENTLY PRESENTED AT ANOTHER INSTITUTION WITH ERYTHEMA OVER THE PACEMAKER POCKET, BUT WITHOUT ANY ACCOMPANYING SYMPTOMS OF SYSTEMIC INFECTION. THE POCKET WAS OPENED ON 3/7/96, AND NECROTIC MATERIAL AS WELL AS PUS WAS FOUND. THE PULSE GENERATOR WAS REMOVED AND THE LEADS CAPPED, IN THAT THE PT IS NOT PACER DEPENDENT. ON 3/13/96 BOTH THE ATRIAL AND VENTRICULAR LEADS WERE EXTRACTED BY MEANS OF EXCIMER LASER EXTRACTION CATHETER.
A PIECE OF THE JAW FRACTURED OFF THE PIN CUTTER WHILE IN USE. THE PIECE THAT FRACTURED OFF WAS RETRIEVED FROM THE WOUND.
PHYSICIAN WAS USING THE MICRODEBRIDER ON AN ENDOSCOPIC SINUS SURGERY. WHEN IT WAS TIME TO USE THE MICRODEBRIDER IT WOULD NOT FUNCTION. PHYSICIAN DETERMINED THAT HE COULD NOT DO THE PROCEDURE WITHOUT THE MICRODEBRIDER. HE CANCELLED THE CASE. PT WAS AWAKEN FROM ANESTHESIA AND TAKEN TO THE RECOVERY ROOM.
PROCEDURE WAS ORIF RIGHT HIP FRACTURE. REAMER WAS NOT PROPERLY TIGHTENED AND CONSEQUENTLY DRILL PASSED THROUGH THE HEAD OF THE FEMUR AND POSSIBLY THROUGH THE ACETABULUM INTO THE PELVIS. PT WAS OBSERVED CAREFULLY FOR CHANGES IN VITAL SIGNS & CHANGES IN URINARY OUTPUT. C-ARM X-RAY IN USE.
PAPILLATOME  WAS BEING USED TO PERFORM AN ENDOSCOPIC RETRROGRADE CHOLANGIOPANCREATOGRAPHY TO IDENTIFY AND REMOVE A BILIARY SYSTEM OBSTRUCTION. IN THE COURSE OF NORMAL USE, THE PAPILLATOME WIRE BROKE WITHIN THE SHEATHING OF THE SCOPE. BOTH SECTIONS OF THE WIRE WERE REMOVED FROM THE PT WITHOUT COMPLICATIONS AND AN X-RAY CONFIRMED COMPLETE REMOVAL. NURSE, REPORTED THIS EVENT TO MFR ON 4/10/96. THE PT SUFFERED NO ILL EFFECTS.
PT HAD BILATERAL RUPTURED SILICONE FILLED BREAST IMPLANTS. SHE UNDERWENT EXCISION OF HER IMPLANTS, ALONG WITH THE CAPSULES. A CAPSULECTOMY REMOVED ALL OF THE CAPSULE AND THE LEFT IMPLANT WAS FOUND TO BE BROKEN, BUT NOT COMPLETELY RUPTURED, INTRACAPSULAR RUPTURES OCCURRED IN BOTH INSTANCES. THE LEFT AND THE RIGHT BREAST HAD INTRACAPSULAR DISRUPTIONS.
PT RECENTLY NOTED IMPLANT WAS NOT FUNCTIONING. AT SURGERY, THE OUTER SHEATH OF BOTH CYLINDERS WERE FOUND TO BE TORN, WITH THE LEFT SIDE TORN MORE EXTENSIVELY. THE RIGHT SIDE LEAKAGE MAY HAVE BEEN DUE TO THE REMOVAL PROCESS. THE PUMP AND RESERVOIR APPEAR INTACT.
THE LEFT IMPLANT WAS RUPTURED, WITH THE DIAGNOSIS MADE PRIOR TO SURGERY. THE PT ELECTIVELY HAD THE RIGHT IMPLANT REMOVED AS WELL.
WHILE TREATMENT WAS IN PROGRESS THE MACHINE ALARMED AIR IN BLOOD. UPON INSPECTION MICROBUBBLES WERE NOTED IN THE VENOUS SIDE OF THE PT'S CATHETER AND FOAM WAS NOTED IN THE VENOUS CHAMBER OF THE CARTRIDGE. PT C/O SOB, CHEST PAIN, DIAPHORESIS, LOW BP AND TACHYCARDIA. PT PLACED ON LEFT SIDE IN TRENDELBURG POSITION, TREATMENT DISCONTINUED, DR. NOTIFIED, O2 AND SALINE GIVEN. PT TRANSPORTED TO LOCAL HOSP WHERE HE WAS EVALUATED AND RELEASED.
THE PHYSICIAN NOTICED AN EXCESSIVE SYSTEM LEAK WHILE DELIVERING DESFLURANE TO A VENTILATED PT. THE UNIT WAS FOUND TO FAIL THE LOW PRESSURE LEAK TEST. THE UNIT WAS REMOVED AND REPLACED, BUT WHEN TESTED LATER, IT PASSED THE LOW PRESSURE LEAK TEST.
ON 9/15/94, THIS LEAD WAS ABANDONED AS NONFUNCTIONAL AND WAS REPLACED WITH ANOTHER LEAD. FLUOROSOCPY ON 5/1/96 DEMONSTRATES TWO FRACTURES (CLASS II) OF THE J-WIRE. RPTR IS ATTEMPTING TO OBTAIN FILMS FROM 9/15/94 TO DETERMINE IF THE LEAD WAS FRACTURED AT THAT TIME. NO FIRM PLANS FOR EXPLANTATION AT THIS TIME.
THE PT'S CATH BECAME PLUGGED AND THE PT HAD TO UNDERGO ANOTHER GENERAL ANESTHESIA IN SURGERY TO REVISE THE CATHETER PORT. THE PT SUSTAINED NO INJURY OTHER THAN ADD'L SURGERY. THE DEVICE IS STILL IN THE PT. IMPLANTED 4/2/96.
DURING REPLACEMENT OF THE PT'S PACEMAKER FOR NORMAL BATTERY DEPLETION, THE ATRIAL LEAD WAS TO BE REPLACED AS WELL. DURING EXTRACTION, THE DISTAL ELECTRODE BECAME SEPARATED FROM THE REST OF THE LEAD, AND REMAINS IN THE SUBCLAVIAN AREA. THE PT ALSO SUFFERED A RIGHT-SIDED PNEUMOTHORAX DURING THE PROCEDURE. THE LEAD WAS GROUP I PRIOR TO REMOVAL.
A 31-YR-OLD MALE HAVING CT SCAN OF CHEST WITH CONTRAST PEFORMED. TECHNICIAN DID NOT REMOVE CONTRAST CARTRIDGE OR TUBING USED FOR PREVIOUS PT. APPROX 100-125CC AIR INJECTED INTRAVENOUSLY. PT DEVELOPED SOB, CHEST PAIN, COUGHING. O2 ADMINISTERED, TAKEN TO ER FOR EVALUATION. DISCHARGED HOME AFTER 90 MINS OBSERVATION.
CLEAR PORT POPPED OFF BAG WHEN INSERTING A SPIKE.
DURING CORONARY ANGIOPLASTY POST STENT DILATION WAS PERFORMED AND BALLOON RUPTURED. THE BALLOON COULD NOT BE REMOVED FROM THE PT EASILY AND PART OF THE BALLOON STAYED IN THE PT'S RIGHT CORONARY ARTERY. ON 6/29/96, PT WAS TAKEN TO SURGERY. CORONARY ARTERY BYPASS GRAFT X2 WITH REMOVAL OF BALLOON FRAGMENTS.
MANUAL BREATH BUTTON IN THE SIMV MODE DID NOT FUNCTION. PT (NEWBORN) HAD TO BE MANUALLY RESUSCITATED AND THEN BAGGED UNTIL ANOTHER VENTILATOR WAS PLACED ON THE INFANT. THIS WAS RENTAL EQUIPMENT. TESTED MANUAL BREATH FUNCTION. DELIVERS MANUAL BREATH IN CPAP MODE. MEETS SPEC.
LEAKING BILATERAL GEL BREAST PROSTHESES.
MANUAL BREATH BUTTON IN THE SIMV MODE DID NOT FUNCTION. PT (NEWBORN) HAD TO BE MANUALLY RESUSCITATED AND THEN BAGGED UNTIL ANOTHER VENTILATOR WAS PLACED ON THE INFANT. TESTED MANUAL BREATH FUNCTION. DELIVERS MANUAL BREATH IN CPAP MODE. MEETS SPEC.
PT HAD AN IMPLANTED VENOUS ACCESS SYSTEM AND MOST RECENTLY HAD BEEN HAVING DIFFICULTY DRAWING BLOOD AND FLUSHING THE SYSTEM. NOTED TO HAVE A BULGE APPARENT UNDER THE SKIN. A CATHETOGRAM SHOWED IT TO BE MIGRATED. SCHEDULED FOR REMOVAL OF THE PORT. UPON REMOVAL OF THE PORT BY THE SURGEON, IT WAS NOTED THAT ONLY 5CM OF CATHETER WAS CONNECTED TO THE PORT AND THE END WAS "FRAYED" AND JAGGED APPEARING. THE PT WAS TRANSFERRED FOR FURTHER EVALUATION AND REMOVAL OF THE REMAINING PORTION OF THE CATHETER. THE CATHETER WAS REMOVED FROM THE HEART VIA ACCESS OF THE FEMORAL VEIN. THE PT TOLERATED THIS PROCEDURE WELL., THE REMOVED PORTION OF CATHETER AND THE PORT ARE SECURED AT THE FACILITY.
WHEN ATTEMPTING TO LIFT PT WITH LIFTER OVER BED, HEARD A LOUD CRACKING SOUND. THE WELD ON THE MAIN JUNCTION OF THE LIFTER CAME APART AND IT COULD NOT BE USED. LUCKILY, THIS HAPPENED WHILE RPTR WAS JUST STARTING TO LIFT AND NOT TRANSFERRING THE PT, WHEN THIS 400 LBS PT WOULD HAVE BEEN HURT SERIOUSLY.
PT WAS STUDIED AND FOUND TO HAVE A LESION IN THE SVC TO THE RCA. STENT WAS PLACED TO THE SVC TO MAINTAIN PATENCY. STENT PREPARED ACCORDING TO CO PROTOCOL. UPON REMOVAL OF THE STENT CATHETER, THE STENT WAS NOT ON CATHETER AND THOUGHT TO BE DEPLOYED. THE SAME DAY PT DEVELOPED CHEST PAIN WITH ST ELEVATION AND RETURNED TO CATH LAB FOR EMERGENCY PROCEDURE. THE SETNT WAS REMOVED WITH SHEATH. PT WAS RESTENTED WITH NO FURTHER COMPLICATIONS.
MANUAL BREATH BUTTON IN THE SIMV MODE DID NOT FUNCTION. PT (NEWBORN) HAD TO BE MANUALLY RESUSCITATED AND THEN BAGGED UNTIL ANOTHER VENTILATOR WAS PLACED ON THE INFANT.
PENILE IMPLANT PUMP MALFUNCTION, WOULD NOT INFLATE, REQUIRED SURGICAL REMOVAL AND REIMPLANTATION OF NEW PUMP. IMPLANTED AT ANOTHER FACILITY 4 YRS AGO AND EXPLANTED AT REPORTING FACILITY 5/8/96.
PT WAS ADMITTED FOR REMOVAL OF LEAD THAT WAS WORKING PRIOR TO CABG SURGERY ON 3/4/96. POST OPERATIVELY, THE LEAD FAILED TO EITHER SENSE OR PACE. LEAD EXTRACTION PROGRESSED UNTIL THE LEAD FRACTURED, LEAVING A 5CM PORTION INCLUDING ELECTRODES REMAINING. THIS PORTION COULD NOT BE REMOVED, HAVING BEEN SUTURED TO THE ENDOCARDIUM ON 3/4/96. THE PT WAS RETURNED TO ANOTHER HOSP WHERE THE REMAINING PORTION WAS SURGICALLY REMOVED. THEIR REPORT CONCERNING THIS INCIDENT IS 220118-1996-0001.
PT SCHEDULED FOR HIGH LIGATION OF RIGHT SAPHENOFEMORAL JUNCTION, STRIPPING OF LONG SAPHENOUS VEIN AND HOOK EXCISION OF MULTIPLE VARICOSE VEINS OF LOWER EXTREMITY. AT ONE INCISION IN THE POSTERIOR LOWER LEG THE #2 HOOK BROKE OFF AND A SMALL TIP WAS LOST. EXTENSIVE EXAM OF LEG WAS DONE BUT TIP COULD NOT BE FOUND. PT TAKEN TO RECOVERY ROOM AFTER COMPLETION OF PROCEDURE WHERE AN X-RAY WAS TAKEN. FUTURE TREATMENT TO DEPEND ON DISCUSSION WITH PT AND FAMILY. TO DATE (5-14-96) NO SURGICAL INTERVENTION WAS REQUESTED.
A SECTION OF THE 6MM PTFE GRAFT MATERIAL WAS IMPLANTED IN THE RIGHT FEMORAL POPLITEAL ARTERY. THE NEEDLE HOLES IN THE GRAFT CONTINUED TO OOZE BLOOD 1 HR POST ANASTOMOSIS.
BILILIGHT PHOTOTHERAPY MACHINE MALFUNCTION: LIGHT WOULD NOT WORK, NEW BULB PLACED, LIGHT STILL NON-FUNCTIONAL. NEW UNIT NEEDED TO BE OBTAINED TO PROVIDE ORDERED TREATMENT.
AT 0800 NURSE ENTERED ROOM, FOUND PT UNRESPONSIVE. BP 100/60, P96, R20, HOB RAISED THEN PT OPENED EYES. PT RECEIVED 57CC (57MG) OF MORPHINE SINCE 2304 (A PERIOD OF 11 HOURS). PRESCRIBED RATE PT SHOULD HAVE RECEIVED THRU THE NIGHT WAS 1 MG/1 HR. IF PT HAD ACTIVATED DOSING HIMSELF HE COULD HAVE RECEIVED A MAX OF 66 MG OVER 11 HRS. (SELF DOSING PARAMETERS WERE 1 MG WITH 6 MIN. DELAY I.E. 6 MG/HR). THE PCA HISTORY WAS NOT RECORDED WHEN NEW SYRINGE WAS ADDED THEREFORE UNABLE TO RETRIEVE INFO THAT MIGHT HAVE DETERMINED CAUSE OF PROBLEM. HOUSE DR CALLED AND PT GIVEN MEDS TO REVERSE NARCOTIC EFFECT. NO RESPIRATORY COMPROMISE. PT RECOVERED FULLY PER HIS SURGEON. PCA PUMP EVALUATED BY CLINICAL ENGINEERING AND DETERMINED TO BE IN GOOD WORKING ORDER.
AS SCRUB TECH REMOVED THE THYROID CLAMP FROM THE UTERUS, ONE OF THE TEETH WAS MISSING. X-RAY WAS TAKEN, AND READ POSITIVE FOR FOREIGN BODY. TOOTH WAS REMOVED VAGINALLY.
REMOVAL OF PENILE PROSTHESIS. SMALL EROSION OF CYLINDER WITH SUBSEQEUNT LEAKAGE.
EXTRUDED PENILE PROSTHESIS WITH INFECTION.
EXTRUSION OF PENILE PROSTHESIS THROUGH URETERAL MEATUS.
UNDERWENT EXPLANTATION OF BILATERAL BREAST IMPLANT. LEFT IMPLANT WAS RUPTURED; RIGHT IMPLANT WAS LEAKING.
.2 MM METALIC PARTICLE LEFT IN PT'S EYE DURING SURGERY TO REMOVE CATARACTS. PHYSICIAN DID REMOVE FRAGMENTS AND RETAINED IT FOR MFR TO TEST FOR TOXICITY AND ANALYSIS OF ORIGIN. BASED ON TESTS CONCLUDING NO TOXICITY THERE SHOULD BE NO PROBLEM FOR THE PT AND PHYSICIAN HAS SEEN NO PROBLEM, TO DATE, WITH PT. FRAGMENT 30 DEGREES PHACO TIPS, PHACO WRENCH WERE EVALUATED BY MFR.
PHYSICIAN CONCERNED THAT A METAL FRAGMENT MIGHT HAVE COME OFF THE PHACO TIP SINCE A .2MM PARTICLE WAS FOUND IN A 2ND PT EYE DURING CATARACT SURGERY. AFTER REPORTS OF TESTING THERE SHOULD BE NO PROBLEM FOR THE PT, PER PHYSICIAN AND FOLLOWUP WILL CONTINUE. NO FRAGMENTS OBSERVED WITH THIS PT. 30 DEGREE PHACO TIPS AND PHACO WRENCH WERE EVALUATED BY MFR.
THE OXYGEN FLOW WAS NOT CONNECTED PROPERLY AT THE OXYGEN FLO-SELECTOR. AS A RESULT OF THE PROBLEM, THE POTENTIAL FOR IMPROPER OXYGEN CONNECTIONS IS EVIDENT. SHORTLY AFTER THE INCIDENT, THE FLOW SELECTOR DEVICES WERE ALL REMOVED FROM SERVICE TO PREVENT REPEATS OF THIS TYPE OF OCCURRENCE.
UNDERWENT EXPLANTATION OF PENILE IMPLANT BECAUSE DEVICE DID NOT FUNCTION. CYLINDER WAS FOUND TO BE BROKEN UPON EXPLANTATION.
STENT BALLOON WOULD NOT INFLATE AT 8 ATM. CATHETER WAS REMOVED AND ANOTHER USED. NO PT INJURY.
REDO MITRAL VALVE. WHEN CHECKED, IT WAS FOUND TO BE LEAKING AROUND THE VALVE BETWEEN THE VALVE AND THE RING. EXPLANTED AND A NEW VALVE IMPLANTED. 16.5 YRS POST MITRAL VALVE REPLACEMENT A STRUCTURAL DETERIORATION.
CAPSULECTOMY AND REMOVAL OF RUPTURED IMPLANTS.
DURING DEPLOYMENT OF STENT THE BALLOON ON THE CATHETER WOULD NOT EXPAND TO SET STENT. DURING REMOVAL STENT BECAME DISLODGED AND LODGED IN THE OSTIUM OF RCA.
ON 1/23/96 THIS 75-YR-OLD GENTLEMAN WAS IN THE CARDIAC CATHETERIZATION LAB, UNDERGOING A PTCA OF THE LEFT CORONARY ARTERY, CAUSING A LEFT MAIN DISSECTION. THE ANGIOPLASTY BALLOON WAS FOUND TO HAVE A HOLE IN THE MATERIAL. THE PT WAS SENT TO THE OPERATING ROOM FOR A CORONARY BYPASS PROCEDURE.
DURING DEPLOYMENT OF STENT, UNIT BECAME DISLODGED FROM CATHETER. PHYSICIAN ADVISES IT MAY HAVE BEEN CAUSED BY TECHNIQUE. STENT WAS DEPLOYED TO DIFFERENT VESSEL AND PERMANENTLY PLACED. NEW STENT WAS INSERTED AND PROPERLY DEPLOYED AT PROPER LOCATION.
THE PT WAS ADMITTED TO THE HOSP FOR SURGICAL REVISION OF A RIGHT TOTAL HIP PROSTHESIS. THE SURGEON DESCRIBED IT AS A FAILED TOTAL HIP COMPONENT WITH WHAT APPEARED TO BE FRACTURED PLASTIC.
THE PT WAS ADMITTED TO THE HOSP FOR REVISION OF HIS RIGHT TOTAL KNEE PROSTHESIS. THE SURGEON NOTED DISPLACEMENT OF THE PATELLAR PLASTIC AND WEAR OF THE TIBIAL INSERT.
PT HAS MTASTATIC BREAST CA. ON 2/5/96, PORT CATHETER INSERTED IN LEFT ARM USING STANDARD TECHNIQUE WITH COMPLICATIONS. ON 6/12/96 ADMITTED TO HOSP FOR CHEMOTHERAPY. NURSING UNABLE TO ACCESS HER ARM PORT AND SENT TO RADIOLGY FOR A DYE STUDY. MD FOUND THAT HER CATHETER HAD BEEN SEVERED AND SEGMENT MIGRATED TO HEART. INTERVENTIONAL RADIOLOGY SNARED SEGMENT AND REPLACED NEW PORT.
THE PT HAD A TOTAL HIP REPLACEMENT IN 6/85. HE WAS ADMITTED 6/19/96 FOR REVISION. THE ACETABULAR COMPONENTS WERE BROKEN.
STAPLER WAS FIRED. STAPLES WERE RELEASED BUT NOT CRIMPED. BECAUSE OF LIMITED BOWEL TISSUE ANOTHER ANASTAMOSIS COULD NOT BE ATTEMPTED. PERMANENT COLOSTOMY DONE.
PT REPORTED TO THE ORTHOPEDIC PHYSICIAN THAT "SOMETHING MOVED IN HIS LEFT FEMUR". X-RAY TAKEN AND REVEALED BROKEN SUPRACONDYLAR FEMORAL ROD.
LPN ATTEMPTED TO D/C FOLEY CATHETER BY DEFLATING BULB WITH SYRINGE. BULB WOULD NOT DEFLATE, THEREFORE, CATHETER CUT. BULB WOULD STILL NOT DEFLATE. M.D. CALLED. M.D. INSERTED NORMAL SALINE INTO PORT UNTIL BALLOON RUPTURED. CYSTOSCOPY PERFORMED TO RETRIEVE RETAINED FOLEY CATHETER FRAGMENT.
ON 2/1/96, A 84-YR-OLD GENTLEMAN WAS BROUGHT TO THE OPERATING ROOM FOR REMOVAL OF A FOLEY CATHETER. THE SURGEON WAS UNABLE TO DEFLATE THE BALLOON THAT WAS PLACED POST PROCEDURE, THEREFORE, HE WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF THE CATHETER.
PT FELL WHILE ON PT SCALE STRICKING LOWER LEGS ON THE CORNER OF THE PROJECTION LOCATED AT THE FRONT OF THE SCALE PLATFORM.  THE INCIDENT RESULTED IN FRACTURES OF THE FIBIA AND TIBIA OF LEG.
THE COMPLAINANT IS AN MD FOR A UROLOGICAL GROUP. HE WANTS TO NOTIFY THE FDA FOR APPROPRIATE EVALUATION AND INVESTIGATION OF A DEFECTIVE INFLATABLE PENILE PROSTHESIS. HE STATES THAT HE'S BEEN REMOVING DEFECTIVE PENILE PROSTHESES WITH TYPICAL TEARS IN THE TUBING ADJACENT TO A CONNECTOR. HE ALSO STATES THAT HE'LL BE RETURNING THE DEFECTIVE DEVICE TO THE FIRM.
EVERY SIX MONTHS THE DEVICE'S FUSE BLOWS AND ITS COMPARTMENT MELTS. RPTR HAD IT SERVICED SEVERAL TIMES. THE MFR WAS CONTACTED AND TOLD HIM THEY HAD DESIGNED THE DEVICE TO DO EXACTLY WHAT HE HAD BEEN COMPLAINING ABOUT. THEY WOULD NOT GIVE A REASON FOR IT. RPTR FEELS THESE INCIDENTS COULD CAUSE A FIRE IN HIS OFFICE. RPTR FEELS THAT THE MFG FIRM IS VERY UNCOOPERATIVE IN RESOLVING THE PROBLEM, OR DOING ANYTHING TO CORRECT THE MALFUNCTIONING OF THE DEVICE.
ON 5/31/94 THE WHEELCHAIR WENT FAST FORWARD ON ITS OWN HITTING A LADY. BOTH LANDED IN THE STREET PLUS THE CHAIR FELL OVER. RPTR'S CHAIR HAS ALSO WORN OUT 5 DRIVE GEARS IN THE LAST 2 1/2 YEARS. EACH GEAR COSTS $450.00. THE RPTR BELIEVES THERE ARE MECHANICAL AND ELECTRICAL COMPONENT PROBLEMS WITH THESE CHAIRS.
PT MAY HAVE INADVERTENTLY DISCONNECTED SIDE PORT/HEMOSTASIS VALVE FROM CO'S SHEATH. PT WAS ON ANTICOAGULANTS WITH A PRO-TIME OF 18 SECS EARLIER THAT DAY. PT WAS FOUND BY ICU STAFF IN SEVERE DISTRESS AND A LARGE POOL OF BLOOD AT THE SITE OF THE INTRODUCER. A CODE WAS CALLED. PT WAS GIVEN VOLUME IN THE FORM OF ALBUMIN. INITIAL RESUSCITATION WAS ATTEMPTED. PT WAS IN ELECTRO-MECHANICAL DISSOCIATION AND WAS UNABLE TO BE RESUSCITATED. SHEATH WAS PLACED DURING SURGERY ON 3/13/96.
RESIDENT WAS ON THE WAY TO A HOME VISIT IN FACILITY VAN. SHE WAS ACCOMPANIED BY VAN DRIVER AND CNA. WHEELCHAIR WAS SECURED TO VAN AND RESIDENT WAS SECURED IN WHEELCHAIR. REAR WHEEL BENT CAUSING RESIDENT TO TIP TO SIDE STRIKING HER HEAD ON THE LEFT SIDE. SHE WAS TAKEN TO ER WITH 4CM LACERATION. RESIDENT RECEIVED SUTURES AND PRESSURE DRESSING. NO X-RAYS OR OTHER TESTS ORDERED. RESIDENT HAD A MASSIVE SUBDURAL HEMATOMA WITH A SHIFT TO THE LEFT AND EXPIRED THE FOLLOWING DAY IN THE HOSP.
FAILURE OF STAPLES TO CLOSE DURING SURGICAL PROCEDURE RESULTING IN PERITONITIS. 5/21: PT UNDERWENT CLOSURE OF GASTRIC FISTULA AND ENTERAL FEEDINGS BEGUN POST-OP. 5/22: PT C/O PAIN, RETURNED TO SURGERY, FEEDING SUBSTANCE NOTED IN PERITONEUM. SURGEON STATED HE FOUND "SEVERAL" STAPLES HAD NOT CLOSED.
DEVICE BECAME UNCOUPLED AT THE CONNECTION BETWEEN THE OUTFLOW GRAFT AND THE PUMP. THE PT HEMORRHAGED AND WAS TAKEN TO THE OR BUT EXPIRED.
PT WAS IN COMPLETE HEART BLOCK BEING PACED BY A PORTABLE DEFIB/PACER DURING AMBULANCE TRANSPORT, FROM EMERGENCY DEPT TO ANOTHER HOSP ACROSS TOWN. AT 12:30 PM THE MONITOR WENT BLANK. CPR WAS INITIATED AND SUSTAINED UNTIL PT'S CARE WAS TAKEN OVER BY OTHER HOSP'S EMERGENCY ROOM STAFF. THERE WAS NO AC OUTLET OPERATING ON AMBULANCE. THERE WAS NO BACK UP BATTERY. PT WAS IN FULL CARDIOPULMONARY ARREST WHEN ACCEPTED BY OTHER FACILITY. PT DIED IN THE EMERGENCY DEPT.
VENTILATOR FAILED TO CYCLE BREATHS FOR INVALID PT UNABLE TO BREATHE ON HER OWN. TECH BAGGED PT FOR 20 MINS WHILE ANOTHER MACHINE WAS LOCATED AND BROUGHT IN. PT SAT LEVELS DROPPED TO 77%. PT RECOVERING. TECHS FOUND PINCHED HOSE IN AUTO-ZERO CIRCUIT. RECENT BOARD CHANGE IN UNIT MAY HAVE CONTRIBUTED TO PROBLEM.
FEEDING TUBE INSERTED, EITHER PUNCTURED OR MIGRATED THROUGH ESOPHOGUS CAUSING A PNEUMOTHORAX.
RIGHT EXCHANGE OF SALINE IMPLANT AND DELAYED BREAST RECONSTRUCTION. CAPSULOTOMY AND AREAS OF CAPSULECTOMY DONE. PT COMPLAINED OF SEVERE PAIN. AREAS NOTED OF HARDNESS AS WELL AS ASYMMETRY. FIBROCYSTIC CHANGES NOTED AT IMPLANT 6/94.
EXCHANGE OF SALINE IMPLANT (LEFT) AND DELAYED BREAST RECONSTRUCTION. CAPSULOTOMY AND AREAS OF CAPSULECTOMY DONE. PT COMPLAINED OF SEVERE PAIN. AREAS NOTED OF HARDNESS AS WELL AS ASYMMETRY.
NONFUNCTIONING BACKCHECK VALVE ON PRIMARY PIGGYBACK IV PUMP SET. THE PIGGYBACKED SOLUTION BACKFLOWED INTO THE PRIMARY INTRAVENOUS SOLUTION. UPON INTERNAL RECALL OF SPECIFIED LOT, THE NURSING STAFF COMMENTED THAT THE PROBLEM HAD OFTEN OCCURRED DURING THE LAST TWO MONTHS.
ON 5/29/96, DR PLACED A GASTROSTOMY TUBE INTO THE PT. ON 7/3/96 DR PERFORMED AN ESOPHAGOGASTRODUODENOSCOPY AND FOUND THE GASTROSTOMY TUBE BULB LODGED IN THE WALL OF THE STOMACH. THE MIGRATED GASTROSTOMY TUBE WAS REMOVED AND A 20 FRENCH GASTROSTOMY TUBE WAS INTRODUCED AND LEFT IN THE APPROPRIATE POSITION.
DRIP CHAMBER OF PRIMARY PIGGYBACK IV PUMP SET WAS MFG IN AN INVERTED POSITION.
NURSE OPENED TUBING PKG. THE TUBING WAS CUT INTO TWO PIECES. NO PT HARM.
DURING ARTERIOGRAM PROCEDURE, GUIDE WIRE REMOVED FROM PT BY PHYSICIAN. GUIDE WIRE INTACT, BUT DEFECTIVE. WIRE BENT APPROX 1 1/2 INCHES FROM THE END.
FRACTURED IMPLANT SCREWS (2) AND ONE DENTAL IMPLANT BODILY FRACTURED INTO TWO PIECES WHILE IMPLANTED.
RESIDENT WAS BEING WHEELED TO DINING ROOM IN CHAIR. THE CHAIR WAS IN A SEMI-RECLINING POSITION. IT DISENGAGED AND PLACED THE RESIDENT IN AN UPRIGHT POSITION. HER FEET WENT TO THE FLOOR AND CAUGHT IN THE FORWARD MOVEMENT, RESULTING IN A NON-DISPLACED RIGHT DISTAL FRACTURE OF HER TIBIA AND FIBULA. TAKEN TO ER FOR X-RAY, AIR-CAST APPLIED, RETURNED TO FACILITY SAME DAY. RESIDENT IS NON-AMBULATORY. NO CHANGE IN ADL STATUS RESULTED FROM THE EVENT.
LEAK IN GASKET OF HEAT EXCHANGERS OF ETO STERILIZER. NEEDED TO BE REPLACED SEVERAL TIMES - POSSIBLE EMPLOYEE EXPOSURE.
TRACH CRACKED DURING INSERTION ATTEMPT AT MOTOR VEHICLE ACCIDENT SITE. DEVICE WAS NOT SAVED. PT PRONOUNCED DEAD - NOT RELATED TO DEVICE FAILURE. THIS EVENT WAS NOT DEEMED MANDITORY REPORTABLE. REPEAT PROBLEM WITH DEVICE PRIOR TO USE ON A PT HAS PROMPTED REPORTING AT THIS TIME, AND DEFECTIVE DEVICE HAS BEEN RETAINED.
AFTER DEPLOYMENT OF STENTS IN LAD, PTCA BALLOON INSERTED TO INFLATE DIAGONAL. THE STENTS PLACED IN LAD CROSSED OSTIUM OF DIAGONAL BRANCH AND WIRE AND BALLOON PASSED AREA SUCCESSFULLY. AFTER TWO INFLATIONS, BALLOON "WINGED" AND UPON RETRACTION UNABLE TO PASS BALLOON BACK THRU STENT THUS UNABLE TO REMOVE BALLOON. PT SENT TO SURGERY FOR BALLOON REMOVAL.
UPON RECAPPING SYRINGE, THE NEEDLE WENT THROUGH SYRINGE CAP AND CAUSED NURSE TO BE STUCK BY NEEDLE. NEEDLE WAS NOTICED TO BE BENT.
PT FEET SLIGHTLY TOUCHING THE BED UNIT AT THE FOOT OF THE BED, AFTER SLIPPING DOWN IN THE BED. SOLES OF FEET SHOWED CIRCULAR BURNS. RIGHT FOOT 4-5 CM, LEFT FOOT 1-2 CM.
AS PHYSICIAN WAS PUSHING NEEDLE THROUGH TISSUE, TIP OF NEEDLE BROKE OFF. PHYSICIAN ATTEMPTED TO LOCATE NEEDLE BUT WAS UNSUCCESSFUL. AN X-RAY VERIFIED THE PRESENCE OF NEEDLE TIP. BUT PHYSICIAN AFTER CONSULTING WITH CHIEF OF SURGERY FELT IT WAS MORE HARMFUL TO ATTEMPT TO RETRIEVE NEEDLE TIP. PHYSICIAN WILL DISCUSS WITH PT.
PICC LINE #3 FR INSERTED WITHOUT DIFFICULTY ON 6/10/96. IV COMPETENT RN/PICC CERTIFIED ATTEMPTED TO REMOVE THE CATHETER 7/16/98 - SLOWLY AND GENTLY WITH A CONSTANT LIGHT PULL - PICC RUPTURED 28 CM REMOVED AND APPROX 16 CM REMAINING IN VEIN. 911 CALLED, PT TRANSPORTED, X-RAY VISUALIZED PICC ABOVE THE ANTECUBITAL FOSSA - LOCAL ANESTHESIA AND CUTDOWN. CATHETER REMOVED PER MD, INCISION CLOSED WITH SILK SUTURES.
MSA CO. PO BOX 427, PITTSBURGH, PA 15230. THIS INSTRUMENT WAS TESTED BY MSA ON 7/29/96, AND MET ALL SPECS. SEE THE ENCLOSED REPAIR HISTORY. SINCE THE COMPLAINT COULD NOT BE VERIFIED, NO FURTHER ACTION WAS REQUIRED OR TAKEN. THE INSTRUMENT WAS RETURNED TO EVERGREEN REHABILITATION CTR ON 8/6/96. AFTER THE INSTRUMENT HAD BEEN RETURNED, MSA RECEIVED THE ABOVE-REFERENCED MEDWATCH REPORT. THEREAFTER, OUR MEDICAL MARKETING MGR, TOM MCCLORY AND I CONTACTED GLENDA CLARK OF THE EVERGREEN REHABILITATION CTR BY TELEPHONE. THE FOLLOWING IS A BRIEF SYNOPSIS OF THE CONVERSATION.
THE PT WAS RUNNING ON TREADMILL AT 7.7 MPH APPROX 10 MINS WHEN THE TREADMILL SUDDENLY STOPPED AND PT FELL FORWARD ONTO THE HANDLEBARS. PT THEN BEGAN TO COMPLAIN OF "STIFFNESS" IN LOW BACK AND PAIN. OVER THE NEXT 15 MINS PAIN INCREASED TO WHERE PT'S LOWER BACK AND LEFT LOWER EXTREMITY WERE PAINFUL. SEEN IN WALK-IN CLINIC FOR EVALUATION BY MD ON 7/3/96. FOLLOW-UP MD APPOINTMENT SCHEDULED 7/10/96.
ANTERIOR CHEST-MOSTLY FIRST DEGREE BURN (AREAS OF ERYTHEMA) AND FEW AREAS OF SECOND DEGREE (BLISTERS). BLANKET WAS PLACED ON PT'S UPPER BODY DAURING SURGERY. ERYTHEMA AND BLISTERING NOTED IN RECOVERY ROOM AT 1500. BLANKET WAS APPLIED FOR APPROX. 2 HOURS 45 MINUTES IN HIGH FOR 1ST 15 MINUTES, THEN IN MEDIUM SETTING.
UPON WITHDRAWAL OF CATHETER, APPROX. 1 CM SHEARED OFF AND REMAINED WITHIN CHEST WALL OF PT.
THIS 44 YR OLD FEMALE UNDERWENT BILATERAL SUB-Q MASTECTOMIES WITH BREAST RECONSTRUCTION IN 1979 OR 1980. THERE IS NO RECORD OF THIS PROCEDURE BEING PERFORMED AT THIS USER FACILITY, THUS THE MFR OF THE SILICONE IMPLANTS IS UNKNOWN TO THIS REPORTING FACILITY. DUE TO PAIN AND BILATERAL BREAST ASYMMETRY, THE PT DESIRES TO HAVE THE IMPLANTS REPLACED. GROSS EXAM: BOTH IMPLANTS ARE RUPTURED, EXUDING A GELATINOUS, TENACIOUS MATERIAL. BOTH CAPSULES DEMONSTRATE FOREIGN BODY REACTION.
AMBULANCE TRANSPORT IN VENTRICULAR FIB. SHOCKED WITH DEVICE BUT NO RESPONSE. THEN DEVICE WOULD NOT CHARGE TO 360, WOULD SHUT OFF AND NOT DISCHARGE. PT CONTINUED IN V FIB FOR 31 MINS, UNTIL ANOTHER DEFIBRILLATOR WAS OBTAINED AND PT SHOCKED 10 TIMES WITH NO RESPONSE. PT EXPIRED. DEVICE TESTED BY HOSP BIOMED. BROKEN WIRES IN CABLE TO PADDLE. NOT VISIBLE FROM OUTSIDE. THEIR OPINION WAS NORMAL WEAR AND TEAR, NOT A PRODUCT DEFECT.
A 76-YR-OLD PT IN CARDIAC ARREST, AN ENDOTRACHEAL TUBE WAS INSERTED INTO THE TRACHEA. PARAMEDIC ATTEMPTED TO INFLATE THE CUFF ON THE ENDOTRACHEAL TUBE; HOWEVER, THE CUFF DID NOT HOLD AIR. THE PT HAD TO BE EXTUBATED AND ANOTHER TUBE INSERTED TO SECURE HIS AIRWAY.
CONTROLLED HEATER/HUMIDIFIER DELIVERING HOT AIR, TEMPERATURE DISPLAY READ 34 DEGREES C. NO INJURY TO PT. ON INSPECTION OF DEVICE FOUND PT CIRCUITS REVERSED AND WATER SUPPLY BOTTLE NOT PUNCTURED COMPLETELY.FURTHER CONVERSATIONS WITH FACILITY PERSONNEL REVEALED THAT THE INCIDENT WAS THE RESULT OF IMPROPER EQUIPMENT SET-UP. THE IMPROPER SET-UP WAS DISCOVERED PRIOR TO BEING USED ON A PT. THE EQUIPMENT WAS FOUND TO HAVE NO MALFUNCTIONS, AND WAS PLACED BACK INTO SERVICE. AT THE FACILITY'S REQUEST, THE MFR HAS PROVIDED TRAINING IN EQUIPMENT USE TO ALL THREE SHIFTS AT THE FACILITY. CO NOW CONSIDERS THIS REPORT CLOSED.
TUBING AT LOWER END OF DRIP CHAMBER DETACHED; IV SOLUTION LEAKED; STERILITY LOST; IV TUBING REPLACED BY NURSING.
PT IMMEDIATELY POST-OP CABG ON VENTILATOR. VENTILATOR ALARM SOUNDED AND VENTILATOR SHUT DOWN COMPLETELY. PT WAS MANUALLY VENTILATED UNTIL A REPLACEMENT VENTILATOR COULD BE BROUGHT TO THE UNIT. NO BAD OUTCOME. PT EXTUBATED AND DOING WELL ON POST-OP DAY 1. VENTILATOR GIVEN TO MFR IN HOPES OF IDENTIFYING REASON FOR PRODUCT PROBLEM.
DRIP CHAMBER DETACHED FROM THE WHITE SPIKE FLANGE. IVPB CONTAINER AND TUBING REPLACED BY PHARMACY AND NURSING TO PROVIDE THE DOSE NEEDED.
ONE LITER GLASS BOTTLE CONTAINING A SOLUTION OF CENTRAL PARENTERAL NUTRITION, SLIPPED OUT OF PLASTIC RING HOLDER HANGING FROM PT'S IV POLE. THE BOTTLE SHATTERED WHEN IT HIT THE FLOOR. THE PLASTIC RING HOLDER WAS RETURNED TO PHARMACY.
REPORT OF BILATERAL CAPSULECTOMY WITH REMOVAL OF IMPLANTS. ONE IMPLANT WAS RUPTURED AND OTHER ONE WAS INTACT.
ORAL SYRINGE MIS-MARKED. HAS 12 ML MARK TWICE AND NO 13 ML MARK. SAMPLES AVAILABLE UPON REQUEST.
REPORT OF BILATERAL CAPSULECTOMY WITH REMOVAL. PT HAD ONE RUPTURED IMPLANT AND ONE INTACT IMPLANT.
TUBING HAS AIR IN IT AFTER PRIMING. THIS HAS BEEN REPORTED PREVIOUSLY VIA MEDWATCH BUT THIS IS A DIFFERENT LOT #.
SV-12 INPUT NIPPLE LEAKED WASH REAGENT (NAOH). DUE TO PLACEMENT OF THIS CONNECTION, NAOH CONTACTED HOUSING OF VACUUM PUMP DESTROYING HOUSING, RESULTING IN ANALYZER FAILURE. RAPID IDENTIFICATION OF PROBLEM BY TECHNOLOGIST PREVENTED POSSIBLE FIRE. THE DESIGN OF THE INSTRUMENT PRESENTS A SIGNIFICANT SAFETY RISK.
TOTAL HIP DONE 13 YRS AGO. DURING LAST SEVERAL MONTHS, PT COMPLAINED OF PAIN IN RIGHT BUTTOCK AND ANTERIOR GROIN AREA. ON 7/10 PT WENT TO OR. ACETABULAR COMPONENT WAS GROSSLY LOOSE AND REMOVED TO ANTERIOR RIM DEFECT  FROM 2 O'CLOCK TO 5 O'CLOCK.
SURGEON USING ELECTROCAUTERY #3 TO CAUTERIZE BLEEDER; HE SUDDENLY JUMPED BACK AND STATED THE MACHINE HAD BURNED HIM. HE HAD ON 2 PAIRS OF GLOVES. ELECTROCAUTERY LIP BURNED ALMOST IN HALF. MACHINE SETTINGS CUT 183, COAG 033.
PHYSICIAN ATTEMPTED TO INJECT CHEMOTHERAPY INTO PORT WHEN PT COMPLAINED OF IMMEDIATE PAIN. CHEST X-RAY TAKEN AND CATHETER WAS FOUND TO BE FRACTURED. THE CATHETER WAS LYING NEAR THE RIGHT ATRIUM AND WAS REMOVED IN THE ANGIOGRAPHY SUITE ON 7/6/96.
AFTER 24 HRS OF BALLOON PUMPING, THE PUMP CONSOLE ALARMED "CHECK IAB CATH", AND LOW AUGMENTATION WAS NOTED. A FINE SPRAY OF BLOOD WAS NOTED IN THE TUBING INDICATIVE OF A LEAK. THE PUMP CONSOLE WAS TURNED OFF, AND THE BALLOON WAS DISCONTINUED. VISUAL EXAM OF THE BALLOON REVEALED A LARGE TEAR - SUSPECT THE TEAR OCCURRED AS THE BALLOON WAS REMOVED. NO PT COMPLICATIONS WERE NOTED. THE BALLOON WAS SENT TO MFR FOR EVALUATION.
LUER LOCK CAME APART. INNER PORTION REMAINED ATTACHED TO CATHETER. RPTR WAS ABLE TO DISCONNECT INNER PORTION WITH GREAT DIFFICULTY.
THE SPIKE ON THE TUBING IS SO SHARP, IT IS PIERCING THROUGH THE NECK OF THE IV BAGS AS IT IS BEING ATTACHED. THIS IS HAPPENING WITH MUCH GREATER FREQUENCY SINCE THE SHARP SPIKE POINTED VERSION REPLACED THE BEVELED, SHARP DESING ON THE TUBINGS. IT IS CAUSING WASTAGE WHICH IS EXPENSIVE AND MEDS ARE HAVING TO BE REMIXED RESULTING IN TREATMENT DELAY.
THE SPIKE ON THE TUBING IS SO SHARP, IT IS PIERCING THROUGH THE NECK OF THE IV BAGS AS IT IS BEING ATTACHED. THIS IS HAPPENING WITH MUCH GREATER FREQUENCY SINCE THE SHARP SPIKE POINTED VERSION REPLACED THE BEVELED, SHARP DESIGN ON THE TUBINGS. IT IS CAUSING WASTAGE WHICH IS EXPENSIVE AND MEDS ARE HAVING TO BE REMIXED RESULTING IN TREATMENT DELAY.
TUBING WOULD NOT FILL BEYOND DRIP CHAMBER. THIS HAS HAPPENED AT LEAST 4 OTHER TIMES IN THE LAST 6 MONTHS.
PT WAS UNDERGOING COIL EMBOLIZATION OF PDI WITH SUBSEQUENT MIGRATION OF COIL INTO LEFT PULMONARY ARTERY. ATTEMPTS AT RETRIEVAL OF COIL EMPLOYING THE SNARE FRACTURED WITH PORTIONS OF THE OUTER SHEATH ALSO EMBOLIZING TO THE PULMONARY ARTERY. THESE WERE NOT RETRIEVED.
A LEAD FILTER IN THE X-RAY ASSEMBLY FELL OUT OF THE MACHINE AS IT WAS NOT SECURELY ATTACHED. RPTR FEELS THE DESIGN IS AN INHERENT FLAW AS THE FILTER IS ONLY GLUED INTO PLACE; THERE ARE NO SCREWS OR RETAINING DEVICES OTHER THAN A THIN STRIP OF GLUE. THIS POSES A RADIATION HAZARD.
PT HAD C-SECTION FOR FAILURE TO PROGRESS, (HISTORY OF BLOODY AMNIOTIC FLUID) LARGE BABY REQUIRED VACUUM PUMP ASSISTANCE FOR DELIVERY OF HEAD. SEAL LOST SEVERAL TIMES, PROBABLY DUE TO HAIR ON INFANT'S HEAD. VACUUM PUMP REAPPLIED 3 OR 4 TIMES UNTIL INFANT DELIVERED. LATER IN NURSERY INFANT DEVELOPED SYMPTOMS SUCH AS MOTTLED SKIN AND WAS TRANSFERRED TO A LEVEL III NURSERY. DIAGNOSIS OF SUBGALEAL HEMATOMA MADE AND INFANT EXPIRED. USE OF VACUUM PUMP WAS WITHIN MFR'S GUIDELINES.
REMOVAL OF LEFT BREAST IMPLANT REVEALED AN INTACT IMPLANT.
A 63 YR OLD MALE, WHO IS 5 WEEKS STATUS POST PLACEMENT OF INFLATABLE PENILE PROSTHESIS FOR ORGANIC IMPOTENCE, DEVELOPED LOW GRADE FEVER WITH PURULENT DRAINAGE FROM THE PENILE SCROTAL INCISION SITE.
DURING LAPAROSCOPIC CHOLECYSTECTOMY, IT WAS NOTICED THAT THE TIP OF THE PLASTIC TROCAR HAD BROKEN OFF.
FAILED TO TURN ON DURING OPERATIONAL CHECK-OUT.
GASTRO - JEJUNAL TUBE WAS PLACED ON 3/6/96. ON 3/8/96 DIAGNOSED AND REPAIRED AND IATROGENIC PERFORATION OF THE FOURTH PART OF THE DUODENUM. PROLONGED HOSPITALIZATION DUE TO PERITONITIS AND SEPSIS SECONDARY TO THE PERFORATION.
ON 8/29/96 AN INSERVICE WAS PERFORMED BY THE MEDICAL REP. THE ANESTHESIOLOGY DEPARTMENT WAS INSTRUCTED ON THE INSERTION METHOD RECOMMENDED IN TH LABELING. IT WAS APPARENT THAT THE ANESTHESIOLOGISTS HAD BEEN USING A DIFFERENT TECHNIQUE IN THE PAST. THE OPERATING ROOM TECHNICIAN AND THE PERSON IN CENTRAL PROCESSING RESPONSIBLE FOR LARYNGEAL MASK AIRWAY CLEANING WERE INSTRUCTED ON PROPER CLEANING AND STERILIZATION METHODS. THE FACILITY'S CURRENT CLEANING AND STERILIZATION PRACTICES WERE REVIEWED AND APPEARED TO BE APPROPRIATE. HOWEVER, AN LARYNGEAL MASK AIRWAY WAS RECENTLY OBSERVED WITH EVIDENCE OF IMPROPER GAS STERILIZATION ONCE AGAIN. THE SITE WAS TOLD TO DISCARD ANY MASKS THAT HAD BEEN GAS STERILIZED. IT WAS CONCLUDED THAT THE SORE THROATS SEEN AT THIS FACILITY WERE PROBABLY THE RESULT OF IMPROPER INSERTION AND THE USE OF GAS STERILIZATION. THIS FILE WILL BE CONSIDERED CLOSED UNLESS ADDITIONAL INFO IS REC'D REGARDING THIS EVENT.
CLEAR HUB ON PICC LINE FOUND WITH A CRACK IN IT WHICH CAUSED IV FLUID LEAK AND BLOOD BACK UP IN LINE. MDS NOTIFIED AT 3AM 6/20/96. TPN STOPPED, PERIPHERAL IV SITE STARTED TO RUN D5.45 NACL WITH 20 MEQ KCL AT 125 CC PER HR. RADIOLOGIST ASSESSED PICC LINE ON 6/20/96 AT 5:45 PM AND MADE ARRANGEMENTS FOR LINE REPLACEMENT ON 6/21/96. NEW PICC LINE PLACED ON 6/21/96 AND READY FOR USE. TPN TO BEGIN AGAIN 6/21/96 AT 10PM.
SURGEON FELT SKIRT OF HEAQD IMPLANT CONTACTED RIM OF ACETABULAR INSERT (TMG) - CAUSING TOO EASY OF DISLOCTION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT AN INVASIVE PROCEDURE WAS PERFORMED TO REMOVE THIS SUTURELESS MYOCARDIAL LEAD BECAUSE OF A LEAD FRACTURE. THE LEAD WAS CAPPED AND REPLACED WITH A NEW SENSING LEAD. IMPLANTED 10/30/94. REMOVED FROM SVC 5/23/96. TOTAL IMPLANT TIME 19 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ONE STAFF MEMBER WITH HISTORY OF LATEX AND POWDER ALLERGIES EXPERIENCED EYES ITCHING AND RASH ON HANDS WHILE USING SYNTHETIC POWDERFREE GLOVES. NO MEDICAL TREATMENT REQUIRED. PRIMARY SKIN IRRITATION STUDY ON FILE AT CO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH A DEFIBRILLATOR (ICD) AND LEAD SYSTEM WAS FOUND TO HAVE AN UNACCETABLE LOW IMPEDANCE ON THE TWO UNIPOLAR RATE SENSING LEADS. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE TWO RATE SENSING LEADS. CO ASSUMES THE LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANTED ON 7/30/93. REMOVED FROM SVC ON 5/15/96. IMPLANT TIME WAS 33.5 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TWO LEADS WERE REMOVED FROM SVC AND CAPPED, DUE TO INAPPROPRIATE OVERSENSING. IMPLANT DATE IS 12/12/91. CAPPED DATE WAS 5/2/96.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT WITH A DEFIBRILLATOR (ICD) EXPERIENCED INAPPROPRIATE SHOCKS. AN INVASIVE PROCEDURE FOUND THE SUTURELESS MYOCARDIAL LEAD TO BE FRACTURED AT THE COSTAL MARGIN. THE PHYSICIAN ELECTED TO REPLACE THE LEAD WITH A BIPOLAR ENDOCARDIAL LEAD. IMPLANTED ON 9/2/92. REMOVED FROM SVC ON 5/21/96. IMPLANT TIME WAS 47 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING A REPLACEMENT OF DEFIBRILLATOR (ICD) ALL LEADS WERE CAPPED. THE TWO SHOCKING LEADS, LARGE PATCH AND SMALL PATCH WERE NOTED TO HAVE "INSULATION WORN DOWN." THE TWO RATE SENSING LEADS, SUTURELESS MYOCARDIAL LEADS WERE NOTED TO HAVE "INSULATION DISCONTINUITY." IMPLANTED ON 10/9/91. REMOVED FROM SVC ON 5/9/96. IN SVC TIME WAS 55 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR EXPERIENCED REDNESS, HIVES, AND ITCHING WHILE WEARING THE SENSI-TOUCH SURGICAL GLOVES WHICH ARE INSIDE THE EYE TRAY PACK. DR TREATED HIMSELF WITH STEROIDS. THE GLOVE MFR IS ANOTHER CO.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHILE PERFORMING A CARDIOVASCULAR RIGHT CAROTID PROCEDURE, THE CAUTERY PENCIL AUTO ACTIVATED. WHEN METAL RETRACTOR WAS REMOVED, IT WAS DISCOVERED THAT SOME MUSCLES HAD BEEN CUT. PT REQUIRED STITCHES. THE FOLLOWING DAY THE DEVICE WAS STERILIZED AND TESTED AND FOUND TO PERFORM AS INTENDED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A PT DEVELOPED A GRANULOMA DUE TO A LINTING LAP SPONGE. SEVERAL ATTEMPTS TO REACH CONTACT AT ACCOUNT HAVE BEEN UNSUCCESSFUL. UNABLE TO CONFIRM CONCERN. UNKNOWN IF MEDICAL TREATMENT REQUIRED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DESCRIBED AS RUPTURED LEFT BREAST SILICONE IMPLANT WITH DISINTEGRATION OF THE SHELL AND PARTIAL RUPTURE OF THE RIGHT SILICONE BREAST IMPLANT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING A LAPAROSCOPIC APPENDECTOMY, THE BOVIE CORD CAUGHT FIRE APPROXIMATELY 1 CM FROM THE LAPAROSCOPE. THE FIRE WAS EXTINGUISHED IMMEDIATELY AND CAUSED NO HARM TO THE PT.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  DEVICE FAILED JUST PRIOR TO USE, DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, OTHER.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LAST X-RAY 1993 LOOKED GOOD. PT FELT SOMETHING GIVE IN HIS HIP. LOOKED LIKE CUP EXPLODED. CUP WAS INTACT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
UPON INSERTION OF TEH PROSTHESIS THE THREADED TIP OF THE DRIVER/EXTRACTOR BROKE OFF FLUSH WITH PROSTHESIS. PROSTHESIS CAME LOOSE AND SURGEON REMOVED IT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT HAD SERIOUS THIGH PAIN 10 YEARS POST-OP. X-RAYS REVEALED FEMORAL STEM SERIOUSLY LOOSENED AND MIGRATING THROUGH LATERAL FEMORAL CORTEX.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT COMPLAINED OF PAIN AND SOME INSTABILITY. REPLACED TIBIAL INSERT AND PATELLA.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
INSERT WOULD NOT SEAT. SECOND INSERT WAS USED AFTER REPEATED ATTEMPTS TO SEAT FIRST COMPONENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHEN SURGEON ATTEMPTED TO IMPLANT INSERT, IT FAILED TO ENGAGE OUTER SHELL. A NEW INSERT WAS OPENED AND DID ENGAGE SHELL.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT SLIPPED AND FELL. THIS RESULTED IN A FRACTURE OF THE PROXIMAL MEDIAL FEMUR WITH DISTAL DISPLACEMENT OF FEMORAL IMPLANT APPROX 1 CM. THIS PT UNDERWENT REVISION HIP ARTHROPLASTY WITH REMOVAL OF THE FEMORAL IMPLANT AND INCIDENTAL REMOVAL OF ACETABULAR INSERT. A NEW INSERT WITH 15 DEGREE HOOD WAS IMPLANTED. A STEM WAS UTILIZED FOR THE FEMUR. TWO 2.0 MM TALL CABLES WERE USED TO SECURE THE FRACTURE.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
NURSE SENSED THERE WAS SOMETHING WRONG WITH SITUATION DURING TESTING FOR POTENCY AND CHEST X-RAY REVEALED THAT THE CATHETER HAS BEEN SHEARED, AND THE DISTAL TWO THIRDS OF THE CATHETER NOW LIES IN THE REGION OF THE RIGHT ATRIUM. THE PROXIMAL TIP ENDS NEAR THE INSERTION OF THE CATHETER INTO THE RIGHT SUBCLAVIAN VEIN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A 61-YEAR-OLD FEMALE WAS ADMITTED FOR EVALUATION OF RIGHT BREAST MASS. PT HAD HISTORY OF BREAST IMPLANTS BILATERALLY IN 1978. PT WAS NOTED TO HAVE RUPTURED BREAST IMPLANT; REQUIRING REMOVAL OF BREAST TISSUE AND RECONSTRUCTION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS DESTROYED/DISPOSED OF.
PT WAS ADMITTED TO SSU FOR ANTIOPLASTY AND STENT PLACEMENT. PT HAD SUCCESSFUL AND UNEVENTFUL DILATION OF RIGHT ILIAC ARTERY WITH PLACEMENT OF VASCULAR STENT. DURING DILATION AND STENT PLACEMENT IN LEFT ILIAC ARTERY, THE ARTERY WAS DAMAGED RESULTING IN INTERNAL BLEEDING. PT WAS TAKEN TO SURGERY TO CORRECT DAMAGE TO LEFT ARTERY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  COMPONENT FAILURE, INHERENT RISK OF PROCEDURE, COMPONENT FAILURE.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE DISCARDED.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
AT APPROX 1100 THICK SMOKE WAS NOTED IN LTC EAST AND WEST HALLS AND RESIDENT ROOMS. RESIDENTS WERE EVACUATED QUICKLY AND NO SMOKE INHALATION OCCURRED TO RESIDENTS. ONE STAFF MEMBER WITH CHRONIC NEUROVASCULAR DISORDER RECEIVED TREATMENT FOR SMOKE INHALATION. INVESTIGATION SHOWED THAT VACUUM PUMP HAD MALFUNCTIONED CAUSING SMOKE TO CIRCULATE THROUGH HEATER VENTS IN LTC RESIDENT ROOMS.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  ELECTRIC PROBLEM - SHORT CIRCUIT.  CONCLUSION:  DEVICE FAILURE INDIRECTLY CAUSED EVENT, DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE TEMPORARILY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEADS WERE CAPPED, AND REMOVED FROM SVC BECAUSE OF AN INSULATION BREAK. IMPLANT DATE IS 7/2/92. REMOVED FROM SVC ON 6/7/96. TOTAL IMPLANT MONTHS WAS 47.2.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LEADS WERE CAPPED AND REMOVED FROM SVC DUE TO OVERSENSING. IMPLANT DATE IS 1/17/92. REMOVED FROM SVC DATE ON 6/12/96. IMPLANTED FOR 52.8 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ON 2/2/96, A 50-YR-OLD FEMALE, HAD REPLACEMENT OF A RUPTURED TISSUE EXPANDER. IT WAS A SPONTANEOUS RUPTURE OF THE TISSUE EXPANDER, ETIOLOGY UNKNOWN. IT HAD BEEN PLACED ON 11/6/95. DATE OF REPORT 7/1/96.
SUPRA PUBIC CATHETER TIP BROKE OFF WHEN PHYSICIAN ATTEMPTED TO REMOVE FROM PT.
PT UNDERWENT CORONARY ARTERY BYPASS GRAFT SURGERY ON 5/24/96. TRANSFERRED TO INTENSIVE CARE UNIT POST-OPERATIVELY. WAS PLACED ON A VENTILATOR. APPROX 2 HRS LATER, THE PEEP MANOMETER WAS READING A NEGATIVE 20. ORDERS WERE FOR A POSITIVE 10 PEEP. PT REMOVED FROM VENTILATOR AND BAGGED. TEST LUNG WAS PLACED ON VENTILATOR WITH NO CHANGE IN READING. VENTILATOR WAS REPLACED.
REMOVED AND REPLACED BECAUSE OF LEAKAGE.
ON 3/3/96, CO'S MONITOR WAS ON A PT IN THE SURGICAL INTENSIVE CARE UNIT. THE PT, A 74-YR-OLD FEMALE, DEVELOPED VENTRICULAR FIBRILLATION FOR WHICH SHE WAS DEFIBRILLATED. IMMEDIATELY AFTER THE DISCHARGE OF THE DEFIBRILLATOR, THE MONITOR WENT BLANK LEAVING THE HEALTH CARE TEAM WITHOUT VITAL EKG TRACINGS. RPTR HAS BEEN TOLD THE MONITOR WAS BLANK/NOT FUNCTIONAL FOR A PERIOD OF 1-1/2 TO 4 MINS WHILE THE PT WAS IN A "CODE" SITUATION. THE PT WAS DEFIBRILLATED A SECOND TIME (THE PT STILL HAD NO PULSE) AND JUST BEFORE DEFIBRILLATING AGAIN, THE MONITOR CAME BACK UP INDICATING THAT THE PT HAD AN ACCEPTABLE RHYTHM.
PT ADMITTED FOR A REVISION OF A FAILED TOTAL HIP. WHILE PHYSICIAN PERFORMING SURGERY, TWO PITUITARY FORCEPS BROKE. AREA CHECKED, NO PIECES FOUND.
PT PRESENTED TO OFFICE FOLLOWING A TWISTING INJURY TO THE LEFT KNEE; AS OF 5/23/96 PT HAD SIGNS OF MENISCAL BEARING DISLOCATION AND JOINT SPACE NARROWING, ACCOMPANIED BY PAIN.
EMERGENCY TRANSPORT TEAM ARRIVED TO TRANSPORT 4-MONTH-OLD CHILD. PT HAD BEEN IN CARDIAC AND RESPIRATORY ARREST APPROX ONE HR UPON THE TEAM'S ARRIVAL. THE PT'S PUPILS WERE FIXED AND DILATED UPON ARRIVAL. PT REMAINED UNSTABLE DESPITE RESUSCITATION EFFORTS, HOWEVER, HAD PERIODIC EPISODES OF RETURN OF CARDIAC RHYTHM AND LOW BLOOD PRESSURE. THE TRANSPORT TEAM TRANSFERRED THE INTRAVENOUS MEDICATIONS, DOPAMINE, DOBUTAMINE AND EPINEPHRINE ONTO CO'S INFUSION DEVICE. AFTER SEVERAL MINS THE CO'S PUMP SWITCHED OFF. THE PUMP WAS THEN PLUGGED INTO THE WALL OUTLET; THE GREEN LIGHT TURNED ON, HOWEVER, THE PUMP DID NOT INFUSE THE MEDICATIONS. ALL INTRAVENOUS MEDICATIONS CONVERTED BACK TO ORIGINAL EQUIPMENT. IT IS UNKNOWN HOW LONG THE MEDICATIONS WERE NOT INFUSING, BUT IS ESTIMATED AT LESS THAN 5 MINS. EPINEPHRINE, BICARBONATE, CALCIUM AND LIDOCAINE CONTINUED TO BE ADMINISTERED THROUGHOUT THE RESUSCITATIVE EFFORT. APPROX ONE HR AFTER THE TRANSPORT TEAM'S ARRIVAL, A DECISION WAS MADE TO DISCONTINUE THE CODE AND THE PT WAS PRONOUNCED DEAD. THIS DEVICE HAS BEEN SENT FOR A PRODUCT EVALUATION. THOSE RESULTS ARE UNKNOWN AT THIS TIME.
PT UNDERWENT HYSTEROSALPINGOGRAM PROCEDURE USING A UTERINE CANNULA INSTRUMENT. TWO DAYS LATER, THE PT PASSED A SMALL ROUND PIECE OF METAL FROM THE VAGINA. IT WAS DETERMINED THAT THE BLACK RUBBER "OLIVE" AND THE METAL PIECE WERE PROBABLY ASSEMBLED IN REVERSE AND THE METAL PIECE CAME OFF.
PENETRATING KERATOPLASTY DUE TO CORNEAL DECOMPENSATION AND PSEUDOPHAKIC BULLOUS KERATOPATHY.
SUTURE NEEDLE IN PACKAGES WAS FOUND TO BE DULL.
THIS TWENTY-SEVEN-YEAR-OLD FEMALE HAD A SCREW IMPLANTED ON 1/2/96. 3/20/96 IT WAS REMOVED FOR THE FIRST REVISION. ON 6/19/96 THE SCREW WAS AGAIN REMOVED. THIS WAS A RESULT OF A BROKEN SCREW.
PT COMPLAINED OF PAIN IN LEFT KNEE STARTING APPROX 1 MONTH AGO; REVISION TOTAL KNEE SURGERY SHOWED A "10 MM LGT MENSICAL BEARING COMPARTMENT" THAT WAS WORN AND BROKEN; PT HAS LARGE AMOUNT OF REACTIVE SYNOVITIS. PATELLA COMPONENT BADLY SCARRED AND REPLACED.
PT WAS IN AUTO ACCIDENT THREE WEEKS AGO. SEAT BELT WAS FORCED AND HELD HER IN PLACE ACROSS THE BREAST. PT DEVELOPED PAIN AND SWELLING - TO OR. IMPLANT ON THE RT BREAST WAS RUPTURED TOWARDS THE SUPERIOR MEDIAL PORTION OF IMPLANT - THE CAPSULE HAD RUPTURED AND THERE WAS SOME LEAKAGE OF FREE SILICONE OUTSIDE THE CAPSULE. IT WAS REMOVED AND NEW IMPLANTS INSERTED.
MALFUNCTIONING, FAILURE TO STAY INFLATED.
SUPERFICIALLY PLACED DRAIN IN LUMBAR AREA BROKE UPON REMOVAL ATTEMPT. PT RETURNED TO SURGERY AND RETAINED DRAIN TUBING REMOVED.
DURING SURGICAL PROCEDURE OF STRIPPING OF RIGHT GREATER SAPHENOUS, TIP OF THE VEIN STRIPPER INSTRUMENT CAME OFF. THE BROKEN PORTION WAS RETRIEVED BY THE SURGEON. PORTABLE X-RAY FOR FOREIGN BODY WAS PERFORMED, WITH NONE FOUND. WOUNDS WERE CLOSED WITH STAPLES AND THE PT RECOVERED WITH NO ADD'L EVENTS.
LAPARASCOPIC CHOLECYSTECTOMY WAS BEING PERFORMED. AS THE SURGEON REACHED TO GRAFT THE GALL BLADDER, THE TIP OF THE INSTRUMENT BROKE OFF.
THREE PADS SPLIT AT THE SEAM WITHIN A 24 HR TIMEFRAME WHILE IN USE ON THE SAME PT. A TREMENDOUS AMOUNT OF INCONVENIENCE RESULTED AND THERE WAS POTENTIAL FOR PT INJURY AS THE PT WAS EXTREMELY CRITICAL.
THE TIP OF THE INSTRUMENT BROKE OFF IN THE INNER EAR DURING SURGERY. THE BROKEN PIECE COULD NOT BE RETRIEVED FROM THE EAR. THE INCIDENT DID NOT CAUSE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR STRUCTURE.
SUBCLAVIAN VEIN THROMBOSIS SECONDARY TO DEVICE.
TELEMETRY ALARM ALERTED NURSING STAFF TO A PROBLEM WITH THIS PT. THE PT WAS FOUND TO BE BRADYCARDIC AND CYANOTIC. VENTILATOR WAS NOT ALARMING. VENTILATOR TUBING WAS FOUND TO BE DISCONNECTED. INVESTIGATION DID NOT REVEAL AT WHAT POINT THE TUBING BECAME DISCONNECTED - PRIOR TO CODE 9 OR DURING CODE 9. IF TUBING WAS CONNECTED, PHYSICIAN NOTED MUCOUS PLUG MAY HAVE BEEN CAUSE OF DETERIORATION IN CONDITION. FOR THE PT TO BE CYANOTIC WITH HEART RATE OF 30-40, THE VENTILATOR SHOULD HAVE ALARMED. THE PT RESPONDED TO THE CODE 9 - BAGGING AND ATROPINE. PHYSICIAN NOTED THAT THE HYPOXIA AND ARRHYTHMIAS MAY HAVE BEEN SECONDARY TO A MUCOUS PLUG OR VENTILATOR MALFUNCTION. THE PT WAS BACK TO PRE-EVENT STATUS.
THE PT HAD OPEN HEART SURGERY ON 6/18/96. AFTER THE PROCEDURE A REDDENED AREA WAS NOTED TO THE LEFT AND 3 INCHES BELOW THE STERNAL NOTCH. THIS WAS REPORTED AS A SUPERFICIAL BURN POSSIBLY RELATED TO ONE OF THE OVERHEAD LIGHTS THAT WAS MISSING A HEATFILTER. AN INVESTIGATION WAS INITIATED TO DETERMINE THE POTENTIAL FOR OTHER CAUSES OF THE BURNS. THE OTHER POSSIBILITY BEING CONSIDERED WAS AN ALTERNATE SITE BURN RELATED TO THE ELECTRICAL EQUIPMENT. THE BOVIE UNIT WAS REMOVED AND CHECKED BY BIOMED. THE MFR HAS BEEN NOTIFIED OF THE INCIDENT. OR STAFF WILL BE INSERVICED REGARDING PROPER PLACEMENT OF PADS. THE OR STAFF WILL BE INSERVICED REGARDING THE CHANGING OF OVERHEAD LIGHT BULBS AND HEAT FILTERS.
THE PT HAD UNDERGONE A RADICAL RETROPUBIC PROSTATECTOMY DUE TO A DIAGNOSIS OF ADENOCARCINOMA OF THE PROSTATE. DURING THIS PROCEDURE, THE SPACE OF RETZIUS WAS DRAINED WITH A DRAIN. FOUR DAYS LATER, WHILE THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE DRAIN, THE TUBING BROKE WITH THE FLAT PORTION WITH THE HOLES REMAINING IN THE PT. THE PHYSICIAN ATTEMPTED TO EXPLORE THE DRAIN TRACT AT THE BEDSIDE AND WAS UNSUCCESSFUL IN FINDING THE END OF THE DRAIN. X-RAYS CONFIRMED THE LOCATION OF THE SEPARATED PORTION AS BEING BELOW THE FASCIAL LEVEL. THE PT WAS TRANSPORTED TO SURGERY WHERE THE ABDOMINAL INCISION WAS RE-OPENED AND THE TERMINAL PORTION OF THE DRAIN WAS IDENTIFIED AND REMOVED. THE BREAK OCCURRED IN THE TUBING APPROX 5/8 INCH ABOVE THE WHITE PORTION WITH THE DRAIN HOLES.
UNABLE TO SEPARATE ET-TUBE ADAPTER (BLUE) FROM ANOTHER CO'S INLINE SUCTION CATHETER. UNABLE TO DISCONNECT PT FROM VENTILATOR CIRCUIT. APPEARED TO HAVE A CHEMICAL BONDING THAT COULD NOT BE SEPARATED BY ANYONE. ET-TUBE AND INLINE SUCTION CATHETER HAD TO BE REPLACED. CO COMPLETED TESTS ON THE PRODUCT FOUND THE ADAPTER TO BE MADE WITH DIFFERENT MATERIAL; ABS MATERIAL INSTEAD OF POLYPROPOLENE. THIS LEAD TO THE ITEM TO BE UNABLE TO DISCONNECT FROM PT VENTILATOR. THE CONNECTOR WAS DISCONNECTED USING A SLIGHT "TWIST" MOTION OF THE PROTRUDED EDGE, (WING), TO THE RIGHT AND THEN PULLED. THE PRODUCT WAS FURTHER DECONTAMINATED, RE-ASSEMBLED AND RE-EXAMINED. SLIGHT RESTRICTION WAS EXPERIENCED WHEN THE AFFECTED AREA WAS MOIST AFTER THE DECONTAMINATION PROCESS. THE OUTER DIAMETER OF THE ENDOTRACHEAL TUBE ADAPTER WAS MEASURED, AND THE DIMENSION WAS WITHIN SPEC. THE CONNECTOR WAS SUBJECTED TO A "JIG" TEST TO GAUGE THE ACCEPTABILITY OF THE OUTER DIAMETER, (MACHINE END), TO THE ADAPTER WHEN UTILIZED IN THE FIELD. THE COMPONENT DID PASS THE "JIG" TEST.
INTENSITY OF THE UNIT HAD TO BE INCREASED IN ORDER TO FEEL. PT ALLEGES MALFUNCTION OF UNIT. SURGEON NOTED THAT GRAFT HAD RUPTURED AND WAS OF UNKNOWN ETIOLOGY.
PT AND WIFE ALLEGES RECEIVING RASH FROM USING CO'S DEVICE. PT AND WIFE WERE SEEN BY PHYSICIAN AND GIVEN OINTMENT FOR RASH. ADVISED TO STOP USING UNIT.
BAGS DO NOT DRAIN PROPERLY. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT.
THIS DISTRIBUTOR BECAME AWARE ON 6/12/96 OF AN INCIDENT THAT OCCURRED INVOLVING A CO'S DEVICE. A PT TRIPPED ON THEIR IV, BREAKING OFF THE EXTERNAL PORTION OF THEIR PICC LINE AND EXPERIENCING AN AIR EMBOLI. THE PT LOST CONSCIOUSNESS FOR ONE MIN. A CPR TEAM RESPONDED AND THE PT REGAINED CONSCIOUSNESS. THE PICC LINE WAS REMOVED AND THE PT'S CONDITION IS STABLE. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. NO MALFUNCTION OF THIS DEVICE OCCURRED. AN INCIDENT RESULTED FROM USER ERROR. CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE.
LOOSE AND PAINFUL IMPLANT IN THE POSITION OF #10. IMPLANT HAD FAILED, AND CAME OUT WITH THE REMOVAL OF THE HEALING CAP.
LOOSE AND PAINFUL. EXTRACTED IMPLANT IN THE POSITION OF #325.
IMPLANT IN POSITION OF #18 STRIPPED DURING PLACEMENT.
LOOSE AND PAINFUL IMPLANT IN THE POSITION OF #27. EXTRACTED THE IMPLANT IN THE TOOTH POSITION OF #27.
IN 1978, PT DEVELOPED ITCHING FOR 3 DAYS FOLLOWING HER FIRST PELVIC EXAM. WHILE WORKING AS AN ICU NURSE IN 1986, PT DEVELOPED WHEEZING AND REQUIRED MEDICATION TO BE TAKEN 4 TIMES A DAY. IN 1995, PT NOTED THAT WHEN USING LATEX GLOVES, SHE WOULD EXPERIENCE HIVES AND WHEEZING. WITHIN A FEW MINS, DURING A DENTAL VISIT, THE DR PLACED HIS HANDS ON THE PT'S CHIN AND PT DEVELOPED HIVES AND WHEEZING, BY THE TIME SHE LEFT HIS OFFICE, ANOTHER INCIDENT OCCURRED WHEN THE PT BEGAN TO WHEEZE AFTER 10 MINS OF ENTERING A HOSP. FOR THE LAST TWO YEARS, PT HAS BEEN WORKING IN THE OUTPT SETTING AND NO LONGER REQUIRES TAKING MEDICATION 4 TIMES A DAY. IN 1/96, PT WAS ON A CRUISESHIP AND NOTICED THE KITCHEN WORKERS USING LATEX GLOVES ROUTINELY. AFTER EATING ONE MEAL, PT BEGAN TO EXPERIENCE HIVES, WHEEZING AND DIARRHEA.
A 48-YR-OLD FEMALE REPORTS ONSET OF SYMPTOMS APPROX 1 YR AGO TO INCLUDE: DRY EYES, GENERAL MALAISE, HIP PAIN, ANKLE PAIN, JOINT PAIN, RIGHT-SIDED CHEST PAIN, HAIR LOSS, MUSCLE PAIN, CHRONIC FAITGUE, HEADACHES, INSOMNIA, CHRONIC DIARRHEA, LUQ ABDOMINAL PAIN, AND SWELLING OF LYMPHNODES IN NECK, GROIN AND AXILLA. HAS SEEN AS MANY AS 12 DIFFERENT PHYSICIANS PER REFERRAL OF PMD AND HAD UNNECESSARY PROCEDURES "WHEN ALL ALONG IT WAS THE IMPLANTS."
PT HAD RIGHT MANDIBULAR REPAIR WITH PLATE AND SCREW FIXATION ON 6/16/96. DURING RIGHT MANDIBULAR EXPORATION FOR INCISION AND DRAINAGE ON 7/8/96, A PORTION OF THE CHEEK RETRACTOR USED DURING SURGERY ON 6/16/96 WAS FOUND.
IMPLANT FELL OUT OF OSTEOTOMY.IMPLANT FELL OUT OF OSTEOTOMY.IMPLANT FELLTTTT IS NOT ON FILE FOR TEXT COPY.  ENTER TEXT.
REPEATEDLY DR NOTICED IN HIS PRACTICE THAT THE TRANSLUCENT CAPS OFF SYRINGE TIPS GET LOST ON THE FLOOR IN THE EXAM TABLE ARENA WHEN VACCINATIONS ARE BEING GIVEN. THESE CAPS ARE JUST THE RIGHT SIZE TO OBSTRUCT SMALL AIRWAYS, AND THEREFORE ARE DANGEROUS. RECENTLY, IN THE LOCAL HOSP, A SYRINGE CAP GOT IN THE AIRWAY OF A YOUNGSTER WHO WAS HAVING CLEFT PALATE WORK PERFORMED. IT WOULD BE HIS RECOMMENDATION THAT MFRS BRIGHTLY COLOR ALL PLASTIC PIECES THAT ARE OF A SIZE THAT COULD OBSTRUCT THE AIRWAY.
BAG DOES NOT DRAIN PROPERLY. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT.
LOOSE AND PAINFUL IMPLANTS IN THE AREAS OF 22, 24, 25 AND 27. RPTR TOOK PERIAPICAL X-RAYS AND FOUND THAT THE IMPLANTS HAD FAILED.
PLACED AN IMPLANT IN THE POSITION OF #29. PT WAS FEELING DISCOMFORT SO RPTR STOPPED IN THE MIDDLE OF THE PROCEDURE, REMOVED THE IMPLANT AND FOUND THAT THE TOP OF THE IMPLANT HAD STRIPPED.
LEAD AND ANOTHER MODEL WERE REMOVED FROM SERVICE BECAUSE OF "MULTIPLE COUNTING." THIS WAS NOTED WHEN "PUSHING ON THE VENTILATOR." THE LEADS WERE CAPPED AND REAMIN IMPLANTED. IMPLANT DATE-3/23/92. REMOVED FROM SERVICE-10/11/94. TOTAL IMPLANT TIME-30 MO.
LOOSE AND PAINFUL IMPLANT. CHECKED IT WITH THE DRIVER, AND IT APPEARED THAT THE HEALING CAP WAS LOOSE. IN AN ATTEMPT TO REMOVE THE HEALING CAP, THE ACTUAL IMPLANT HAD SCREWED OUT ON ITS OWN.
WHILE PLACING A COMBINED A SPINAL EPIDURAL, THE NEEDLE STYLET STUCK AND COULD NOT BE EASILY REMOVED FROM THE NEEDLE.
PT ADMITTED ON 1/30/96 FOR REPLACEMENT OF DEPLETED DRUG INFUSION PUMP BATTERY. PT SUBSEQUENTLY EXPIRED ON 4/27/96.
PT HAD BREAST AUGMENTATION 14 YRS AGO. MVA 12/12 AND HAD PROBABLE RUPTURE OF IMPLANT. PT HAD PAIN IN BOTH BREASTS. PT HAD BILATERAL CAPSULECTOMIES WITH REMOVAL OF IMPLANT MATERIAL. PATH REPORT = RUPTURED IMPLANTS BILATERALLY.
PT WITH HISTORY OF EMPHYSEMA AND RECENT BRONCHITIS COLLAPSED AT HOME. MEDICS ARRIVED, UNRESPONSIVE, INTUBATED AND TRANSPORTED TO HOSP. DEFIBRILLATION PERFORMED FOR V-FIB. DEVICE WAS CHARGED TO 200 J (SYNCH). NOT ON MACHINE READ "ENERGY DELIVERED". RN TURNED FROM MACHINE TO CHECK PT'S PULSE. UPON TURNING, THE RESP THERAPIST (R.T.) PLACED KNEE ON BED AND HAND/WRIST ON PT'S CHEST TO RESUME CPR, HER WRIST BRACELET TOUCHED THE PT AND SHE RECEIVED A SHOCK. THERE WAS AN AUDIBLE "POP" AS THE DEFIBRILLATOR FIRED A FEW SECONDS AFTER THE BUTTONS WERE PUSHED AND NO ONE WAS IN CONTACT WITH DEVICE. THE R.T. RECEIVED A VISIBLE JOLT. PT REQUIRED A 2ND SHOCK. EXISTING PADS THAT CAME IN VIA MEDIC I WERE REMOVED WITH LEFT CHEST PAD NOTED TO BE "PARTIALLY TENTED" AND NOT IN COMPLETE CONTACT WITH PT, NEW PADS WERE APPLIED. DEFIBRILLATOR AGAIN CHARGED TO 200 J AND SHOCK DELIVERED WITHOUT DELAY. LATER EXPIRED.
ON 4/24/96, THIS 15-MONTH-OLD INFANT WAS NOTED TO HAVE AN 8-10CM TIP CATHETER IN THE KIDNEY, APPARENTLY FROM A RETROGRADE PYELOGRAM DONE ON 6/23/95. REMOVAL OF THE TIP DID NOT OCCUR UNTIL 4/19/96. CO BELIEVES IT IS SIMILAR TO A 3FR CO'S CATHETER.
POP WAS HEARD WHILE RETRACTORS WERE STILL ON, BUT STITCHING WAS BEING DONE. FOLEY PIECE CAME OUT AND ENTIRE BALLOON PIECE WAS DISCONNECTED FROM REST OF DEVICE. ADD'L SURGERY WAS REQUIRED TO REMOVE THE BALLOON SECTION OF THE FOLEY.
DURING PLACEMENT, THE CATHETER PULLED APART LEAVING APPROX. 9 CMS IN THE INFANT'S UMBILICAL AREA. RETRIEVAL WAS NOT POSSIBLE, INFANT TRANSFERRED TO HOSP. FACILITY REPORTED PT'S DEATH THROUGH RISK MANAGEMENT/QUALITY OFFICE. EXTERNAL PART OF DEVICE SENT TO MFR.
DURING LAPROSCOPIC TUBAL LIGATION AND CYSTS REMOVAL ON OVARIES, IRRIGATION TRUMPET VALVE STUCK. FLUID BUILT UP IN CAVITY QUICKER THAN COULD BE SUCTIONED OUT RESULTING IN IMPAIRED VISIBILITY. SURGEON FELT MALFUNCTION OF DEVICE WAS A MAJOR FACTOR IN HIS DECISION TO REMOVE THE OVARY.
TWO YEARS AFTER SECOND RIGHT KNEE REPLACEMENT, THE SCREW DISASSOCIATED ITSELF FROM THE FEMORAL COMPONENT. SCREW DID NOT APPEAR CROSS THREADED OR DAMAGED.
06/11/96 AORTIC VALVE AND ASCENDING AORTA REPLACED WITH HOMOGRAFT. PT CONVALESCED WELL POST-OPERATIVELY UNTIL 6/21/96. PT FOUND ON FLOOR, PULSELESS. FIFTEEN MINUTES EARLIER SHE WAS ALERT, ORIENTED AND WITH GOOD PULSE OXIMETRY ON 4 LITERS OXYGEN. RESUSCITATION INCLUDING OPEN CARDIAC MASSAGE WAS PERFORMED. BLEEDING FROM THE AORTIC SUTURE LINE WAS NOTED AND THE PT WAS BROUGHT TO THE OR. OPERATIVE FINDINGS INCLUDED A MASSIVE TAMPONADE AND BLEEDING FROM THE DISTAL SUTURE LINE BETWEEN THE ASCENDING AORTA AND THE HOMOGRAFT. THE PT WAS PLACED ON BYPASS AND THE TEAR FROM THE DISTAL SUTURE LINE WAS SUTURED. THE PT DID NOT IMPROVE AND RESUSCITATION MEASURES WERE STOPPED.
PHYSICIAN WAS USING PERFORATOR TO MAKE A HOLE IN THE CRANIUM. THE BRAIN WAS SWOLLEN AND DURA THIN. THE PERFORATOR DID NOT CUT OFF AND PLUNGED THROUGH THE DURA. A SECOND PERFORATOR WAS TRIED AND ALSO DID NOT CUT OFF. NO ADVERSE EFFECT NOTED AT THIS POINT FOR PT'S CLINICAL CONDITION. DISCHARGED 7/8/96.
AT 11:15P.M, PT WAS FOUND SITTING ON THE FLOOR LEANING AGAINST THE BED WITH TH CHEST RESTRAINT DRAWN UP TO THE NECK. THE RESTRAINT RELEASED AND PT WAS LIFTED INTO BED. PT WAS UNRESPONSIVE, NOT BREATHING, PUPLIS WERE DILATED AND NOT REACTING TO LIGHT AND THERE WAS NO APICAL HEART RATE. PT WAS PRONOUNCED DEAD AT 11:45 P.M.
PT UNDERWENT A RIGHT AXILLARY NODE DISSECTION AND RE-EXCISION OF MARGINS ON 6/21/96. A 10MM DRAIN WAS PLACED IN AXILLA SUBQ TISSUE AND WAS CLOSED. J-TUBING WAS ANCHORED WITH ONE STITCH. ON 6/26/96, SURGEON REMOVED THE STITCH AND GENTLY PULLED THE DRAIN OUT. ONLY THREE INCHES OF THE ELEVEN INCH DRAIN CAME OUT. ON 6/26/96, THE SURGEON EXPLORED THE AXILLA FOR THE DRAIN AND WAS UNABLE TO FIND IT USING FLUOROSCOPY.
PT RECEIVED LEFT HEART CATHETERIZATION WITH LEFT VENTRICULAR ANGIOGRAM AND RIGHT AND LEFT CORONARY ANGIOGRAM, PTCA AND STENT; INITIALLY TOLERATED PROCEDURE FAIRLY WELL. PT DEVELOPED POSSIBLE TAMPONADE AFTER TRANSFER BEGAN FROM CATH LAB; EXPIRED AFTER MULTIPLE ATTEMPTS TO RESUSCITATE.
THIS PT WAS HAVING A TOTAL HIP ARTHROPLASTY. AFTER THE CEMENT WAS INJECTED, THE PROSTHESIS INSERTED, AND THE EXCESS CEMENT REMOVED, THE PT'S BP DROPPED AND SHE REQUIRED FULL RESUSCITATION. SHE WAS TAKEN TO ICU AND SHE REMAINED ON A VENTILATOR FOR A FEW DAYS. SHE IS IMPROVING.
ARTHROSCOPY PUMP SET UP FOR PROCEDURE (RIGHT LATERAL MENISCUS TEAR REPAIR). ALARM SOUNDED AND PUMP STOPPED DURING PROCEDURE (3 TIMES). AT COMPLETION OF PROCEDURE PT'S LEG WAS SWOLLEN AND REQUIRED FURTHER TREATMENT.
PT WAS SET UP ON DEVICE TO RIGHT FOOT IN AN INTERFERENTIAL PATTERN BECAUSE OF EXCESSIVE DISTAL EDEMA. UNIT WAS PLACED IN EDEMA REDUCING MODE AND INTENSITY WAS INCREASED TO 50. NO SIGN OF ELECTRICAL CURRENT WAS NOTED. THE INTENSITY WAS LOWERED TO 0 AND ALL PLUG-INS WERE AND LEADS WERE PUSHED IN FIRMLY. THE INTENSITY WAS INCREASED WITH SIGNS OF CURRENT AT 33. TREATMENT TIME WAS SET FOR 20 MINS. THIRTEEN MINS INTO TREATMENT, WHEN ASKED, PT REPORTED PAIN AT TREATMENT AREA. INTENSITY REDUCED TO 30 AND PAIN WAS RELIEVED. NO VISIBLE SIGN OF SKIN DAMAGE PRESENT AT THAT TIME. AT THE END OF THE TREATMENT THE ELECTRODES WERE NOTED AS HOT AND SEVERE BURNS WERE OBSERVED. THE PT HAS SUBSEQUENTLY BEEN SURGICALLY TREATED FOR THESE BURNS.
PT CAME IN TO EMERGENCY WITH A BROKEN LEFT SUBCLAVIAN (3" TUBING) LINE THAT FELL OUT AND HAS BEEN LEAKING. UPON REMOVING DRESSING THE LINE BROKE OFF WITH THE HUB CLAMPED IMMEDIATELY. SURGEON WAS CALLED AND CATHETER REPLACED.
PT AWOKE ON 5/22/96 WITH BLEEDING FROM CENTRAL LINE. CAME TO HOSP VIA AMBULANCE WITH DIFFICULTY BREATHING. PER THE SURGEON, IT WAS NOTED THAT THE CATHETER ITSELF WAS NOTED TO BE FRACTURED IN AN OBLIQUE FASHION ACROSS THE HUB WHICH HAS REALLY NEVER BEEN SEEN BY SURGEON BEFORE. HE HAD CRACKED LINES BUT NOT AT THIS PORTION OF THE CATHETER. AT ANY RATE, SUTURES WERE REMOVED. THE LINE WAS TRANSVERSED WITH #11 BLADE AND INTRALUMINALLY AFTER PREPARATION OF THIS ENTIRE AREA WITH BETADINE, A GUIDE WAS PLACED OVER THE GUIDE WIRE, THE PREVIOUS CATHETER WAS REMOVED AND THE NEW CATHETER WAS PLACED OVER.
PT WAS ON CONTINUOUS HEPARIN DRIP. LAB WORK PTT7200. PUMP DRIP WAS STOPPED UNTIL 2:45 PM. DRIP WAS RESTARTED. PUMP WAS SET AT 20CC/HR. IT WAS NOTED THAT FLUID WAS FLOWING MUCH FASTER THAN ORDERED (THAN SET RATE). PUMP PLACED ON PAUSE AND DRIP CONTINUED TO DRIP.
ON 6/19/96 PT WAS TO UNDERGO OUTPATIENT PLASMAPHERESIS FOR IGM ASSOCIATED SENSORY POLYNEUROPATHY. WHILE HOOKING UP THE CO'S PLASMA EXCHANGE TUBING, THE MEDICAL PROFESSIONAL INADVERTENTLY PLACED THE RETURN SALINE NEEDLE IN THE IV PORT OF ANOTHER CO'S 500CC ANTICOAGULANT CITRATE DEXTROSE SOLUTION RATHER THAN THE PORT OF THE NACL SOLUTION. WHILE SET-UP WAS BEING COMPLETED THE CITRATE SOLUTION INFUSED COMPLETELY INTO THE PT. THE PT EXPERIENCED A RESPIRATORY ARREST REQUIRING INTUBATION AND TRANSFER TO ICU FOR HYPOXIC ENCEPHALOPATHY. AS OF THIS DATE THE PT IS EXTUBATED, REMAINS IN ICU AND IS RESPONSIVE TO VERBAL COMMUNICATIONS WITH FAMILY AND STAFF.
WHEN PT IS IN CPAP MODE AND IF HIGH PRESSURE ALARM IS ACTIVATED, THERE WAS NO WAY TO RESET THE ALARM UNLESS UNIT WAS TURNED OFF OR MANUAL BREATH DELIVERED.
PHYSICIAN WAS DEPLOYING A STENT. WHILE POST-DILATING STENT, PTCA BALLOON FAILED TO DEFLATE. PROXIMAL END OF BALLOON SHAFT WAS CUT WHICH ALLOWED PARTIAL DEFLATION. THE PARTIALLY DEFLATED BALLOON HAD TO BE PULLED ACROSS PROXIMAL LAD AND THE ARTERY TORE. PT BECAME UNSTABLE. BALLOON PUMP WAS PLACED. PT WAS TAKEN TO OR FOR OPEN HEART REPAIR OF DAMAGED ARTERY. PT WAS RELEASED HOME IN GOOD CONDITION ON 6/20/96.
UNWITNESSED FALL FROM BED RESULTED IN A FEMUR FRACTURE. THE BED SIDERAIL WAS FOUND ON THE FLOOR DETACHED FROM THE BED. MFG DESIGN: THE BED ASSEMBLY EMPLOYS A MALE SIDERAIL PORTION AND A ROTATING FEMALE BED FRAME COUPLING THAT ARE SECURED IN PLACE WITH A SPRING-LOADED LOCKING PIN. WHEN DETACHED, THE FEMALE COUPLING TENDS TO ROTATE TO A RESTING POSITION ABOUT 180 DEGREES FROM ITS REATTACHMENT POSITION. IN THIS RESTING POSITION, IT IS MOST LIKELY FOR AN OPERATOR TO IMPROPERLY REATTACH THE SIDERAIL BY INSERTING THE MALE SIDERAIL PORTION INTO THE ROTATED FEMALE COUPLING, PREVENTING LOCKING PIN ALIGNMENT AND THUS DEFEATING SECUREMENT.
IAPB BALLOON CATHETER RUPTURED ON 3RD DAY OF USE AFTER CABG X 3. PT EXPIRED SHORTLY AFTER BALLOON RUPTURE. FINAL DIAGNOSIS ON AUTOPSY  WAS DEATH DUE TO LOW CARDIAC OUTPUT AND RENAL FAILURE. THE PT WAS CONSIDERED TERMINAL PRIOR TO BALLOON RUPTURE. UPON EXAM, THERE ARE THREE HOLES IN THE BALLOON: ONE  3MM AND ONE 4 MM FROM THE BALLOON-CATHETER JUNCTION, CONSISTENT WITH DAMAGE CAUSED DURING AUTOPSY AND A 3RD @ 5.5 MM CONSISTENT WITH ABRASION WITH AORTIC PLAQUE.
PT COLLAPSED AT HOME IN THE PRESENCE OF RELATIVES. CPR WAS INITIALLY PERFORMED BY FIRE RESCUE TEAM. WHILE PARAMEDICS WERE ATTEMPTING TO DELIVER INITIAL 3 TIER DEFIBRILLATION ON CARDIAC ARREST PT, HAND HELD DEFIB PADDLES FAILED TO DELIVER SHOCK THREE TIMES. IMMEDIATELY SWITCHED TO REMOTE HANDS FREE CABLE SYSTEM AND PROVIDED DEFIB. RESULTED IN SUCCESSFUL CONVERSION TO DIFFERENT RHYTHM (ASYSTOLE). TOTAL DELAY UNDER ONE MIN.
ATTEMPTING TO LIFT PT WITH LIFTER OVER BED AND HEARD A LOUD CRACKING SOUND. THE WELD ON THE MAIN JUNCTION OF THE LIFTER CAME APART AND IT COULD NOT BE USED. LUCKILY, THIS HAPPENED WHILE HCP WAS JUST STARTING TO LIFT AND NOT TRANSFERRING THE PT, WHEN THIS 400 LBS PT WOULD HAVE BEEN HURT SERIOUSLY.
CEMENT LIQUID AMPULE CRUSHED AND BROKE INTO MULTIPLE PIECES UPON OPENING.
PT PRESENTED WITH LOSS OF VENTRICULAR CAPTURE AND SENSING. OPERATIVE INVESTIGATION DISCLOSED OXIDATIVE DAMAGE IN THE VENTRICULAR DISTAL WIRE INSIDE THE PACEMAKER.
THE DEVICE'S HEAD CLAMP WAS APPLIED TO THE PT CRANIUM AND ATTACHED TO THE TABLE ATTACHMENT. THE PT'S HEAD SLIPPED, MOVED AND THE PINS CAME OUT OF THE SKIN CAUSING A SMALL LACERATION AT ONE PIN SITE. THIS REQUIRED ONE SUTURE. THE HEAD REST WAS REMOVED AND ANOTHER ONE USED.
STEM FRACTURED MID-STEM. PHYSICIAN REVISED HIP.
OB PT AT 40+ WKS GESTATION UNDERGOING PITOCIN INDUCTION. PITOCIN INDUCTION STARTED AT 0848 AT 6CC/HR (2 MU/MIN.) ON #2 SIDE OF DOUBLE PUMP. AT 0852 FETAL BRADYCARDIA WITH 3 MINUTE CONTRACTION. PUMP TURNED OFF, SOLUTION CONTINUED TO DRIP. CRIMP NOTED BETWEEN FLOW CLAMP AND TUBING CHANNEL. PITOCIN STOPPED VIA ROLLER CLAMP. ESTIMATED FLOW RATE 100-150CC/HR. PUMP DID NOT ALARM. FETAL HEART TONES RETURNED TO NORMAL. BABY BORN 6/4 AT 1710-APGARS 9/9, NO LONG TERM AFFECTS APPARENT.
PT WAS FOUND WITHOUT PULSE. PROBE WAS CONNECTED TO PT'S FINGER, BUT DISCOVERED CORD CONNECTION BECAME DISCONNECTED. PULSE OXIMETER ALARM TURNED DOWN TO LOW TO REGISTER AN AUDIBLE ALARM.
CAPSULECTOMY AND REMOVAL OF INTACT IMPLANTS.
DEFIBRILLATOR FAILED WHEN SET UP FOR A CODE RED, IMMEDIATELY REPLACED.
THE FOLLOWING BUTTONS ON THE KEYPAD WOULD NOT WORK: TIDAL VOLUME, LOW INSP. PRESSURE, ENTER, MANUAL INSP., CPAP 8 AND 9. NO DISTRESS TO PT-VENT. PULLED OUT OF ROOM.
SCOPED KNEE, VERIFIED PLASTIC DELAMINATION. OPENED KNEE, REMOVED INSERT AND REPLACED WITH MODULAR REVISION INSERT. DR ATTRIBUTES POLY WEAR TO HEAT PRESS PLASTIC.
FRACTURE OF PATELLA POLY. SEPARATION OF POLY FROM METAL BACK LEADING TO METAL ON METAL WEAR BETWEEN THE PATELLA AND FEMUR. REPLACED PATELLA WITH LARGE PCA ALL POLY PATELLA.
THIS DISTRIBUTOR BECAME AWARE ON 7/10/96 OF AN EVENT THAT OCCURRED INVOLVING AN INTRODUCER SHEATH WHILE PERFORMING AN ILIAC RUN OFF PROCEDURE. THE GUIDEWIRE FROM THE INTRODUCER KIT WAS ADVANCED THROUGH AN ENTRY NEEDLE INTO THE FEMORAL ARTERY. AS THEY WERE ADVANCING THE WIRE THE C-ARM LOST POWER. A PORTION OF THE WIRE BROKE AND DETACHED IN THE PT'S GROIN. AN INCISION WAS MADE AND HEMOSTATS WERE USED TO SUCCESSFULLY RETRIEVE THE SEGMENT WHICH WAS APPROX 5 CM IN LENGTH. FOLLOW-UP FROM THE USER FACILITY SUGGESTS TWO OPTIONS MAY HAVE OCCURRED. THE GUIDEWIRE MAY HAVE ENTERED A NATIVE VESSEL WHERE A BYPASS GRAFT HAD BEEN AND THE WIRE MAY HAVE CAUGHT ON CALCIFICATION. OTHER FOLLOW-UP SUGGESTS THE WIRE BROKE WHEN PULLING IT OUT OF THE ENTRY NEEDLE. THE PT EXPERIENCED NO SEQUELAE AS A RESULT OF THIS EVENT.
CONTROLLED HEATER/HUMIDIFIER WAS DELIVERING VERY HOT AIR AND THE DIGITAL TEMPERATURE DISPLAY READ 82C. NO INJURY TO PT.FURTHER CONVERSATION WITH FACILITY PERSONNEL REVEALED THAT THE DETAILS OF THE INCIDENT WERE NOT AVAILABLE. THE FACILITY STATED THAT THE DR FELT THE AIR WAS HOT, ALTHOUGH NO MEASUREMENTS WERE TAKEN. THE FACILITY ALSO STATED THAT THE DR MAY HAVE BEEN STANDING OVER THE HEATER AND MISTAKENLY READ A "28" AS AN "82" ON THE DISPLAY. THE EQUIPMENT WAS FOUND TO HAVE NO MALFUNCTIONS, AND WAS PLACED BACK INTO SERVICE. AT THE FACILITY'S REQUEST, THE MFR HAS PROVIDED TRAINING IN EQUIPMENT USE TO ALL 3 SHIFTS AT THE FACILITY. CO NOW CONSIDERS THIS REPORT CLOSED.
THE PEG WAS INSERTED ON 5/16/96. THE PT RETURNED TO THE HOSP ON 5/25/96 WITH A HEMORRHAGING ULCERATED AREA IN THE STOMACH AT THE SITE OF THE PEG INSERTION. THE PT WAS RE-SCOPED AND THE FEEDING TUBE WAS REMOVED AND ANOTHER MFR'S TUBE WAS INSERTED. A BLOOD TRANSFUSION FOLLOWED. NO FURTHER DETAILS ARE AVAILABLE WITH REGARDS TO THE CIRCUMSTANCES SURROUNDING THIS EVENT.
PT RECEIVED 500 ML OF DEMEROL. HISTORY SHOWS HE RECEIVED ONLY 3ML. AT THE TIME THE PUMP WAS STARTED, PLUNGER WAS FOUND IN THE UP POSITION WITH A LARGE AIR-GAP IN THE SYRINGE. DOSE 1.0 ML, DELAY 10 MIN, ONE HOUR LIMIT 6.0 ML, AND TOTAL GIVEN 3.0 ML.
IV BAG SPIKE PORT DISCONNECTS FROM BAG DURING SPIKING. MFR STATES THAT SPIKE PORT IS GLUED ONTO BAG. BAG IS AN EVA MATERIAL. WHEN BAG PORT DISCONNECTS, STERILE PRODUCT BECOMES NON-STERILE AND CANNOT BE USED. RPTR HAS HAD 5 OCCURRENCES OF THIS PROBLEM SINCE THE INITIAL DATE (3/1/96) OF OCCURRENCE. MFR WAS SENT DEFECTIVE BAGS AND CLAIMS THEY DID NOT RECEIVE THEM. THEY WERE UNABLE TO DEMONSTRATE PROBLEM WITH OTHER LOTS. THEY HAVE OFFERED NO FURTHER FOLLOW-UP TO PROBLEM. THIS DEFECTIVE PRODUCT CAN POTENTIALLY CAUSE INTRODUCTION OF BACTERIA INTO PTS THUS RESULTING IN SERIOUS HARM OR DEATH. TWO HUNDRED AND FORTY BAGS WERE SENT TO CO FOR TESTING OF THE ENGAGEMENT OF THE SPIKE PORT TO THE PORT TUBE. CO COULD FIND NO MEANS OF DISLODGING THE SPIKE PORT FROM THE PORT TUBE USING A PUSH/PULL TECHNIQUE, PIERCING THE SPIKE PORT WITH A SPIKE AND WITHDRAWING SAME, OR BY PRESSURIZING THE BAG WITH AIR.
RUPTURED SILICONE GEL BREAST IMPLANTS, BILATERAL. PT HAS IMPLANTS.
PT ASSESSED AND STABLE WITHOUT ANY DIFFICULTY INTO LEFT BASILIC VESSEL. PT TOLERATED WELL. 2" SLOWLY ADVANCED WITH NORMAL SALINE FLUSH AND EXCELLENT BLOOD RETURN. FOR NEXT 15 MINS SLOWLY ADVANCED 1/4 INCH AT A TIME AND FLUSHED WITHOUT DIFFICULTY. AT 5 1/4 INCHES NURSE NOTED PT VERY QUIET AND PALE. PT UPON QUESTIONING REPORTS HORRIBLE PAIN IN HER LOWER BACK WHICH SHE NEVER HAD BEFORE. 0830 BP 148/88, PULSE 88 AND REGULAR, RESPIRATION 24. SKIN SLIGHTLY MOIST, PEDAL AND FEMORAL PULSE BILATERALLY. ABDOMEN WITH NO AUDIBLE BRUIT. PT STATES HER HEART IS POUNDING IN HER ABDOMEN. GENTLY ROTATED TO RIGHT SIDE TO ATTEMPT TO RELIEVE BACK PAIN AND RUBBED. DENIES CHEST PAIN. 8:35, STATES SOMETHING IS TERRIBLY WRONG, SOMETHING BAD IS GOING TO HAPPEN. BP 132/82. PULSE 78. RESPIRATIONS 24. CATHETER GENTLY REMOVED (PT NOT AWARE). 8:36 STATES PAIN IS RELEASING. 8:40 BP 132/84. PULSE 68+ REGULAR. RESPIRATION 19+, PAIN IS ALMOST GONE. 0900 UP AND AMBULATED, REACTION TOTALLY SUBSIDED.
PICC LINE WAS PLACED WITHOUT DIFFICULTY. TEN MINS LATER, PT COMPLAINED OF PUFFY LIPS, THEN WHEEZING; HIVES APPEARED ON RIGHT ARM. LINE WAS REMOVED. PT WAS GIVEN BENADRYL AND AN INHALER. RESP STATUS RETURNED TO NORMAL. LIPS WERE STILL PUFFY AND HIVES REMAINED ON LEGS AND STOMACH.
DURING SURGERY TO PLACE AN IM ROD, THE PIN OF THE INSTRUMENT USED TO PLACE THE ROD WAS BROKEN OFF AND IS STILL RETAINED WITHIN THE PT. AT THIS TIME, THE PT HAS HAD NO ILL EFFECTS FROM THIS.
PT DISCONNECTED WHILE ON CO'S VENTILATOR AT A HOSP. NURSES REPORTED THEY DID NOT HEAR ALARM. INVESTIGATION PENDING COMPLETION REGARDING HOW DEVICE MIGHT HAVE BECOME DISCONNECTED, WHETHER ALARM SOUNDED OR WAS CIRCUMVENTED BY PT. ALARM FUNCIONED DURING TESTS.
PT HAD A RIGHT KNEE PROSTHESIS IN PLACE. PT REPORTED HAVING PAIN AND IMMOBILITY OF RIGHT KNEE ON 5/10/96. PT WAS SEEN BY MD ON 5/12/96. THE X-RAY SHOWED A FRACTURE. THE PT REQUIRED SURGERY TO REPLACE THE KNEE SYSTEM PROSTHESIS. THE SURGERY WAS DONE ON 5/23/96.
PT HAD SURGERY 5/15/96 ON 6/13/96 AT 10:00 AM, RECEIVED CALL FROM DR STATING SHE JUST EXAMINED PT AND CAN SEE PIECES OF METAL IN PT'S EYE. PT HAS NO COMPLAINTS.
SURGEON FOUND PIECE OF METAL ON EYE UPON INITIATION OF PHACO HANDPIECE.
RESIDENT WAS BEING PLACED INTO CO'S TUBE WHEN HER FINGER AND HAND WHICH WERE IN THE AREA OF THE SIDE OF TUB AND CHAIR REST WAS OBSERVED TO BE CUT AND BLEEDING.
DR UPON PLACING PHACO HANDPIECE IN EYE NOTICES SHARD PIECES OF METAL IN THE EYE.
VENTILATOR, WHILE ON PT, ALARMED AND WAS NO LONGER PUMPING AIR. PT'S NURSE WAS IN THE ROOM AND STARTED VENTILATING PT WITH AN AMBU BAG. PT WAS TAKEN TO HOSP. VENTILATOR WAS REPLACED AND PT RETURNED HOME.
PICC LINE PLACED. LINE BEING SLOWLY ADVANCED SUCCESSFULLY. PT C/O BEING "DIZZY" AND FLUSHED, C/O SHORTNESS OF BREATH, BECAME HYPOTENSIVE. PT SENT TO ICU. CATH REMOVED. PT STABILIZED.
WHITE BALANCE NOT WORKING ON CAMERA POWER SOURCE. UNABLE TO PERFORM LAPAROSCOPIC CHOLECYSTECTOMY. OPEN CHOLECYSTECTOMY DONE. CAMERA POWER SOURCE TO BE REPLACED.
IV TUBING LEAKING FROM JOINT UNDER THE FILTER WHILE PRIMING.
A PART OF THE VENTILATOR'S EXHALATION VALVE ASSEMBLY LOOSENED, CAUSING UNSTABLE BASELINE PRESSURE AND INADEQUATE SENSING OF PT'S BREATING EFFORT. EXHALATION VALVE ASSEMBLY WAS REPAIRED BY HOSP'S TECH. SAME TYPE OF FAILURE HAS BEEN OBSERVED IN OTHER VENTILATORS AT THIS HOSP. PART OF NORMAL SET-UP PROCEDURE FOR VENTILATOR, IE INSTALLATION OF EXHALATION VALVE DIAPHRAGM, REQUIRES A MODEST FORCE IN A DIRECTION THAT TENDS TO LOOSEN ANOTHER COMPONENT OF THE EXHALATION VALVE ASSEMBLY AND MAY EVENTUALLY ALLOW THIS PROBLEM TO OCCUR AGAIN.
DURING PTCA PROCEDURE, STENT, WAS INTRODUCED BUT WAS NOT DEPLOYED. WHEN EQUIPMENT WAS REMOVED FROM PTS BODY STENT WAS NOT RETRIEVED. STENT WAS LOST INSIDE PT'S BODY.
BALLOON BEING USED FOR 1ST TIME. BALLOON PASSED THRU ENDOSCOPE AND INFLATED TO PSI OF 45. AFTER ONE MIN OF INFLATION, BALLOON BROKE.
PT WAS REFERRED TO A CLINIC TO HAVE A BROKEN EPICARDIAL LEAD EXPLANTED.
SCREWS WORKED OUT OF TABLE LEGS ON ONE SIDE. THIS WAS SECOND OCCURRENCE WITH THIS PIECE OF EQUIPMENT. FORTUNATELY NO PT ON TABLE EITHER TIME. SVC REP CONTACTED TO REPAIR.
CYLINDERS THAT CONTROL THE LIFTING OF THE TABLE NOT WORKING PROPERLY. THIS MAKES TABLE DIFFICULT TO MOVE. SVC REP CONTACTED TO REPAIR.
7/19/95 PT HAD BILATERAL BREAST AUGMENTATION. PT NOW DESIRES TO HAVE ROUND IMPLANTS OF SAME SIZE. "OLD IMPLANTS ARE TOO HIGH ON TOP."
ORIGINAL IMPLANTS RUPTURED. LEFT IMPLANT INTACT. RIGHT AND LEFT IMPLANTS REMOVED AND REPLACED WITH SALINE IMPLANTS. ORIGINAL IMPLANTS PUT IN 10 YEARS AGO.
TUBING FOUND TO BE DISCONNECTED FROM PORT ITSELF. PORT PLACED 6/6/95 FOR CHEMO ADMINISTRATION.
ANTERIOR CERVICAL HARDWARE REMOVED BECAUSE OF SCREWS BACKING OUT AND COMPRESSING ESOPHAGUS CAUSING DIFFICULTIES SWALLOWING.
DRILL IN USE. ELECTROSURGICAL UNIT ON WITH ACTIVE ELECTRODE LYING ON STERILE DRAPES AT THE PT'S AXILLARY LEVEL. WHEN THE DRILL WAS KEYED, IT ACTIVATED THE ELECTROSURGICAL UNIT. THE DRAPES HAD A 2 MM SIZE HOLE BURNED THROUGH AT THE SITE WHERE THE ELECTORSURGICAL PENCIL TIP WAS LYING ON THE PT. WHEN THE DRAPES WERE REMOVED, A 2 MM SIZE REDDENED AREA WITH A SMALL HOLE IN THE SKIN WAS NOTED.
PRODUCT WAS SURGICALLY IMPLANTED IN PT ON 4/8/95. THE LAST REPORTED USE WITHOUT INCIDENT WAS 2/26/96. ON 3/11/96 DURING ATTEMPTED USE OF PRODUCT, NO BLOOD RETURN WAS NOTED. AT THAT POINT PT WAS SENT FOR STUDIES WHICH CONFIRMED VIA CHEST X-RAY AND FLUOROSCOPY THAT PORT TUBING HAD SEPARATED AND LODGED IN RIGHT VENTRICLE AND RIGHT VENTRICLE OUTFLOW TRACT. ON 3/12/96 PT UNDERWENT REMOVAL OF PORT RESERVOIR AND SILICON CATHETER. POSTOPERATIVELY, PT DID NOT EXPERIENCE ANY SIGNIFICANT LEG OR CHEST PAIN, AND CATHETER SITE WAS HEALING WELL.
CURVED BLADE SHAVER HAD FRAGMENTS COME OFF BLADE DURING USE - HAPPENED WITH 2 DIFFERENT LOT #'S. MACHINE CHECKED OUT BY BIOMEDICAL PEOPLE AND OPERATORS PROBABLY NEEDED TO SWITCH TO STRAIGHT BLADE.
THE PT IS A 56 YR OLD WOMAN WHO HAD HISTORY OF BREAST CANCER ON THE RIGHT SIDE AND UNDERWENT A MODIFIED RADICAL MASTECTOMY WITH IMMEDIATE RECONSTRUCTION ON 1/3/85 USING A DOUBLE LUMEN TYPE IMPLANT. THE PT NOTED, WITHIN ONE YEAR COSTOCHONDRITIS AND INTENSE ITCHING AROUND THE IMPLANT. THEN, IN THE LAST FEW YEARS, SHE FELT SHE DEVELOPED CHRONIC FATIGUE, SHORT TERM MEMORY LOSS, SHORTNESS OF BREATH, DRY EYES, DRY MOUTH, HAIR LOSS, FREQUENT RASHES, CHILLS AND SWEATS. TOTAL CAPSULECTOMY IS NECESSARY IN THIS CIRCUMSTANCE BECAUSE THE CAPSULE WILL CONTAIN SILICONE WHICH THE PT MAY BE REACTING TO.
THE PT IS A 42 YR OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION IN 1987 IN PLACE OF A MASTOPEXY USING SILICONE GEL BREAST IMPLANTS, LEFT SIDE 350CC, RIGHT SIDE 375CC. FOLLOWING A CAR ACCIDENT IN 1986, THE PT DEVELOPED A GREAT DEAL OF NECK PAIN RADIATING TO THE LEFT ARM. WITHIN SIX MONTHS SHE ALSO DEVELOPED INCREASED ALLERGIC REACTIONS TO MEDICATIONS. IN ADDITION, SHE HAD POOR SLEEP, MYALGIA, ARTHRALGIAS, SPASMS IN THE EXTREMITIES, AND CHRONIC FATIGUE. IN 1990, SHE BEGAN DEVELOPING BURNING PAIN IN THE LEFT BREAST WHICH HAS WAXED AND WANED OVER THE YEARS. SHE HAS COMPLAINTS OF FORGETFULNESS AND NUMBNESS AND TINGLING IN THE LEGS WITHIN A PROLONGED PERIOD OF SITTING. LOCAL PAIN AND CONTRACTURE. THE PT WOULD LIKE IMPLANT REMOVAL. TOTAL CAPSULECTOMY IS NECESSARY BECAUSE THE CAPSULE CONTAINS SILICONE WHICH THE PT MAY BE REACTING TO.
THE PT IS A 33 YR OLD WOMAN WHO INITIALLY HAD BILATERAL BREAST AUGMENTATION FOR ASYMMETRICAL TUBULAR BREAST DEFORMITY IN 1989. THE PT AT THAT TIME HAD AN AUGMENTATION MASTOPEXY USING MEME POLYURETHANE COVERED IMPLANTS, 120GRAMS ON THE LEFT AND 160 GRAMS ON THE RIGHT. WITHIN THREE MONTHS THE PT DEVELOPED FATIGUE, ARTHRALIGIA, MYALGIA, HAD INCREASING ASTHMA ATTACKS AND DISCOMFORT AROUND THE IMPLANTS. HER SYMPTOMS HAVE PROGRESSIVELY GOTTEN WORSE. ON PHYSICAL EXAM, SHE HAS CLASS 2 CONTRACTURES IN BOTH BREASTS. ULTRASOUND EXAM SHOWS BOTH IMPLANTS INTACT; HOWEVER, SHE HAS SILICONE ADENOPATHY IN THE AXILLAS AND INTERNAL MAMMARY. AS A RESULT OF MULTIPLICITY OF SILICONE LYMPHADENOPATHY, IT IS MEDICALLY NECESSARY TO REMOVE THESE IMPLANTS IN VIEW OF POSSIBLE SYSTEMIC SYMPTOMS THAT MAY BE RELATED TO HER BREAST IMPLANTS.
THE PT IS A 53 YR OLD WOMAN WHO HAD BILATERAL BREAST AUGMENTATION IN 1976, USING THE SILICONE GEL FILLED BREAST IMPLANT. THE PT DEVELOPED DRY EYES IN 1993, AND FREQUENT HEADACHES SINCE 1990 DUE TO AN ACCIDENT, WHIPLASH INJURY. SHE ALSO HAD ROSACHES IN THE CHEEKS, IN THE NOSTRIL AREA, IN THE MALAR DISTRIBUTION AS WELL AS FREQUENT SHARP PAINS IN BOTH BREASTS. XEROMAMMOGRAM AND ULTRASOUND EXAM DEMONSTRATES DEFINITIVE INTRACAPSULAR RUPTURE ON BOTH SIDES. THE RIGHT SIDE HAS A COLLAPSED SHELL RUPTURE. BECAUSE OF RUPTURE, LOCAL CONTRACTURE AND PAIN AS WELL AS SOME SYSTEMIC SYMPTOMS THAT MAY BE RELATED TO HER BREAST IMPLANTS, SHE DESIRES BREAST IMPLANT REMOVAL. TOTAL CAPSULECTOMY IS MEDICALLY NECESSARY BECAUSE OF RUPTURE AND CALCIFICATION OF THE BIOLOGICAL CAPSULE.
PT HAS A TRACHEOSTOMY AND IS VENTILATOR DEPENDENT. ON 5/11/96 THE PT NEEDED SUCTIONING AND THE RN WAS UNABLE TO DETACH THE VENTILATION ADAPTER FROM THE TRACH TUBE. THE PLASTIC SWIVEL SLEEVE OF THE TRACH WAS ANCHORED INTO THE VENTILATOR AND IT WAS IMPOSSIBLE TO DISENGAGE THE TWO. THIS NECESSITATED AN EMERGENCY TRACH CHANGE ON THE PT. THERE WAS NO CHANGE IN STATUS OF THE PT. WHEN THE TRACH DID COME APART, THE SWIVEL SLEEVE REMAINED STUCK IN THE VENT AND COULD ONLY BE REMOVED BY PRYING IT OUT WITH HEMOSTATS.
IV CATHETER SAFETY SYSTEM "Y" ADAPTER REMOVAL PRN-20GA 1 INCH. AFTER NURSE INSERTED THE CATHETER SHE WAS PULLING THE STYLET OUT, IT BROKE THE PLASTIC CATHETER AND NEEDLE (STYLET) STUCK HER.
DURING CABG PT WAS ON BYPASS. APPARENT OXYGENATOR FAILURE FOR 15 MIN (SUBSTANDARD BLOOD FLOW). BLOOD FLOW CONTINUED, TO DECREASE WITH RPMS IN RANGE OF 4000-4300. FLOW STARTED AT 4.5L, THEN 3.4L, TO 1.5L AT 30 DEGREES CELSIUS. FLOW THEN INCREASED TO 3.6L AND IMPROVED.
2-3 DEVICES HAD TO BE USED TO STOP SEVERE EPISTAXIS. BALLOONS ON DEVICE BROKE.
EMPLOYEE APPLIED TB MASK PROPERLY OUTSIDE THE PT'S ROOM AND CHECKED FOR CORRECT FIT. AFTER THE EMPLOYEE WAS IN PT'S ROOM FOR SEVERAL MINS - MASK STRAPS BROKE AND SNAPPED OFF. MASK FELL TO FLOOR. THE EMPLOYEE IMMEDIATELY LEFT THE ROOM.
AT THE CONCLUSION OF T+A WITH BILATERAL MYRINGOTOMY IT WAS NOTED THAT PT SUSTAINED 2 SMALL CHARRED AREAS ON RIGHT SIDE OF LOWER LIP FROM ELECTROCAUTERY HANDSWITCHING PENCIL. THIS WAS OF MAJOR CONCERN AS THE TIP OF THIS PENCIL HAD NOT BEEN IN CONTACT WITH THE LIP. BIOMED ENG EXAMINED EQUIPMENT AND NOTED LED SCORCHING ON BOTH THE PENCIL AND THE NEEDLEPOINT TIP. IT APPEARS THAT WHEN THE TWO SCORCHED AREAS ARE MATED THAT THE NEEDLE WAS NOT INSERTED TO THE STOPPING POINT IN THE PENCIL. INSERTION WAS HOWEVER NOTED TO BE DIFFICULT POSSIBLY DUE TO A DEFECTIVE PENCIL.
A 62 Y.O. FEMALE WHO HAD RIGHT BREAST CANCER WITH RECONSTRUCTION/BREAST IMPLANT DONE IN 1989 AT AN UNKNOWN FACILITY. ACCORDING TO THE FEBRUARY OF 1996 WHICH SHOWED THE IMPLANT TO BE LEAKING. PHYSICAL EXAM REVEALED NOTICEABLE CAPSULAR CONTRACTURE AND BREAST ASYMMETRY. ON 5/16/96, SHE WAS TAKEN TO SURGERY FOR REMOVAL OF THE IMPLANT. THERE WAS EVIDENCE OF SILICONE BLEED IN THE PERIPROSTHETIC CAPSULE IN THE FORM OF SOME SMALL SILICONE GRANULOMAS.
DURING CHOLECYSTECTOMY IT WAS NOTED THAT HANDSWITCH REMAINED ACTIVATED AFTER SURGEON REMOVED PRESSURE FROM COAG ACTIVATION BUTTON. IT WAS AT THIS TIME THAT THE SURGEON AND SURGICAL TECH ALSO NOTED A 0.1 CM ARROWHEAD SHAPED CHARRED AREA ON PT'S ABDOMEN APPROX 2 INCHES FROM INCISION SITE.
FAILED ANTERIOR CERVICAL SPINE INSTRUMENTATION. SURGEON, WOULD LIKE A RESPONSE FROM THE MFR REGARDING THE CAUSE OF THE PROBLEM.
BREAST IMPLANT SLIDES TO THE SIDE. CONSUMER STATED, IT IS NOT THE RIGHT SIZE AND DOESN'T THINK THE OPERATION WAS "COMPLETELY DONE." CONSUMER CANNOT GET ANY INFO AND DOES NOT KNOW WHO THE DR WAS THAT PERFORMED THE IMPLANTATION SURGERY. PT WANTS THEM REMOVED AND CORRECTED.
A TRACHEOSTOMY CUFFLESS TUBE HAD COME DISCONNECTED AT THE FLANGE. CLOSER OBSERVATION REVEALED THAT THE WIRE REINFORCED TUBE WAS TORN AWAY 50% FROM THE ADAPTER END. THIS WAS A NEW TRACHEOSTOMY TUBE THAT HAD BEEN IN USE FOR 7 DAYS.
ARTERIAL CATHETER IN LEFT FEMEROL GROIN SITE, WHEN REMOVED, CAME APART IN 2 PIECES WHICH CAUSED SIGNIFICANT BLEEDING AND HYPOTENSION. EXAM OF THE CATHETER: APPEARS AS IF THE LUMEN DISCONNECTED FROM PORT HEAD AT THE CONNECTION.
DURING INTUBATION LARYNGOSCOPE BLADE DISENGAGED FROM HANDLE. PIVOTAL ROLLER WAS WEDGED IN BLADE, PIVOTED PIN WAS MISSING. UNABLE TO FIND. X-RAY WAS NEGATIVE FOR FOREIGN BLADE. ON CONSULT WITH CO QA TECHNICAL SVC THE "SET SCREW WAS MISSING."
RESIDENT TRANSFERRED TO ACUTE CARE ACCORDING TO FACILITY (HOSP) AND WAS ADMITTED ON 4/12/96. ACCORDING TO HOSP N.N.'S ON 4/12/96, FEEDING TUBE WAS INSERTED. PLACEMENT CONFIRMED BY X-RAY INCLUDING VISUALIZATION OF "TUBE TIP". ON 4/16/96 INDICATES PT "PARTIALLY PULLED OUT FEEDING TUBE". X-RAY CONFIRMED "FEEDING TUBE IS IN GOOD POSITION IN THE STOMACH" (ABD. X-RAY). X-RAY OF CHEST READS "FEEDING TUBE TIP IS NOT INCLUDED ON THE FILM". NURSE'S NOTE ON 4/26/96 INDICATE "TUBE FEEDING NOT INFUSING, NO ASPIRATE NOTED". NURSE'S NOTE ON 4/25/96 INDICATE FEEDING TUBE AT 0030". FURTHER NURSE'S NOTE INDICATE PT WAS SENT TO G.I. LAB FOR G-TUBE PLACEMENT. PT RETURNED TO THIS FACILITY WITH G-TUBE IN PLACE. RESIDENT PASSED WHAT APPEARS TO BE THE WEIGHTED END OF A FEEDING TUBE WITH BOWEL MOVEMENT 7/6/96.
HEATING PAD GAVE RPTR 3RD DEGREE BURN. HAD SURGERY AND STILL NOT IN GOOD HEALTH TO THIS DAY. RPTR FORCED TO GO TO TRIAL. MFR NEVER PAID MEDICAL BILLS OR LOST WAGES. PT OUT OF WORK FROM 6/94 TO 4/95. 3RD PARTY HAS EXAMINED AND TESTED HEATING PAD PROVIDED. PT WAS USING HEATING PAD ON HER BODY, UTILIZING CLOTH COVER, AND WHEN SHE FINISHED HER TREATMENT FOUND THAT SHE WAS BADLY BURNED WHERE HEATING PAD HAD BEEN POSITIONED. HEATING PAD WAS SET UP IN LAB INSIDE CLOTH COVER. THERMOCOUPLES WERE PLACED BETWEEN CLOTH AND AREA TO BE HEATED. THERMOCOUPLES WERE ALSO PLACED INSIDE CLOTH COVER DIRECTLY AGAINST HEATING PAD. HEATING PAD WAS OPERATED ON EACH OF THE THREE SETTINGS FOR EACH OF ABOVE CONDITIONS. ROOM TEMP DURING THESE TESTS WAS 70 DEGREES F. MAX TEMP REACHED WAS 194 DEGREES F IN 17 MINS. CORRESPONDING TEMP MEASURED ON OUTSIDE SURFACE OF CLOTH COVER WERE AS FOLLOWS: HI - 185 DEGREES F MAX, MED - 147 DEGREES F MAX, LOW - 121 DEGREES F MAX. SURFACE OF HEATING PAD CONTAINS A NUMBER OF INSTRUCTIONS AND WARNINGS. ONE OF THE WARNINGS STATES THAT "BURNS MAY OCCUR REGARDLESS OF CONTROL SETTING. CHECK SKIN UNDER PAD FREQUENTLY TO AVOID BURNING AND BLISTERING." TEMP PRODUCED BY HEATING PAD AS MEASURED IN LAB TESTS ARE CLEARLY OF SUFFICIENT MAGNITUDE TO CAUSE BURNING OF FLESH AT ANY OF THE THREE SETTINGS - LOW TO HIGH. THERE IS A LOWER THRESHOLD OF TEMP BELOW WHICH NO BURNING WOULD OCCUR IRRESPECTIVE OF LENGTH OF EXPOSURE TIME. WARNINGS ON SUBJECT HEATING PAD CLEARLY INDICATE THAT, AS TEMP DEVELOPED BY SUBJECT HEATING PAD, BURNS CAN OCCUR IF EXPOSURE TIME IS LONG ENOUGH - TEMPS ARE ABOVE THRESHOLD LEVEL. WARNINGS SUGGEST "FREQUENT" CHECKING TO AVOID THIS BURNING. TERM "FREQUENT" IS OBVIOUSLY VAGUE AND IS TOO OBLIQUE TO ALERT SOMEONE THAT TIME OF EXPOSURE PUTS USER IN PERIL OF SEVERE BURN INJURIES. IT SHOULD BE NOTED THAT TEMPS AT WHICH BURNING CAN OCCUR ARE REACHED IN A VERY SHORT PERIOD OF TIME - ABOUT 5 TO 6 MINS. WARNING IS QUALITATIVELY INSUFFICIENT AND INADEQUATE FOR SEVERE RISK INVOLVED IN USE OF HEATING PAD. THIS IS ESPECIALLY TRUE IN VIEW OF UNUSUAL NATURE OF BURNING PROCESS. IN CARE OF HEATING PAD, BECAUSE OF UNUSUAL NATURE OF BURNING PROCESS, BURNING OCCURS WITHOUT WARNING AND WITHOUT SENSATION OF PAIN - HENCE ONE IS UNAWARE OF PHYSICAL DAMAGE BEING PRODUCED. THAT MFR WAS AWARE OF THIS UNUSUAL HAZARD IS IMPLICIT IN WARNING TO "CHECK THE SKIN UNDER PAD FREQUENTLY" - BECAUSE ONE WOULD NOT BE ALERTED TO NORMAL SENSATIONS ASSOCIATED WITH BURNING AND WOULD NOT BE AWARE THAT BURNING WAS OCCURRING. THERE IS NO QUESTION THAT MFR WAS AWARE OF THESE RISKS PRESENTED BY PRODUCT. MFR COULD HAVE ESTABLISHED A SAFE TIME LIMIT FOR EXPOSURE AND STATED THESE LIMITS IN WARNING, OR IT COULD HAVE REDUCED TEMP OF HEATING PAD TO THRESHOLD LEVELS. MFR COULD ALSO HAVE INCORPORATED AN AUTOMATIC ELECTRONIC TIMER SHUTOFF IN CONTROLS. SUCH A TIMER SHUTOFF WOULD PROTECT A USER WHO MAY FALL ASLEEP DURING USE OF THE HEATING PAD - A FORESEEABLE RISK RECOGNIZED BY THE MFR. (*)
CHEMOTHERAPY INTERRUPTED FOR 4 HRS DUE TO PUMP FAILURE. PUMP ALARMED AND PT UNABLE TO RESOLVE. TURNED PUMP OFF, PUMP THEN TURNED BACK ON. DASHES ACROSS THE SCREEN WITHOUT VERTICAL HOLD APPEARED. PUMP WOULD NOT DO UNIT SELF TEST. PUMP REMOVED FROM SVC AND NEW PUMP GIVEN TO RESIDENCE.
ONE WEEK PREMATURE INFANT ON HIGH FREQUENCY OSCILLATOR WITH CO'S HUMIDIFIER AND TEMPERATURE PROBE. INFANT WAS ON THIS DEVICE SINCE BIRTH WITH NO PROBLEMS. ON 2/11 INFANT BEGAN TO BE VERY AGITATED AND BP INCREASED. WHEN INFANT WAS TAKEN OFF THE OSCILLATOR TO BE BAGGED WITH ANOTHER BAG THE HUMIDIFIED OXYGEN FROM THE OSCILLATOR CIRCUIT WAS FELT TO BE HOT. NO ALARMS HAD GONE OFF. INFANT PLACED ON ANOTHER VENTILATOR. INFANT SUFFERED A PULMONARY HEMORRHAGE AND STROKE. EQUIPMENT IS BEING CHECKED BY AN INDEPENDENT THIRD PARTY WHICH DETERMINED INVESTIGATION INTO THE SITUATION.
THE PT WAS TO RECEIVE A THREE ISOCENTER TREATMENT OF THE GAMMA KNIFE. THE FIRST SHOT WAS COMPLETED WITHOUT INCIDENT. DURING COUCH WITHDRAWAL ON THE SECOND SHOT, THE BED MOVED OUT TO WITHIN 4" SHORT OF THE FINAL POSITION. THE DOOR DID NOT CLOSE. THE CUSTOMER ATTEMPTED TO CLOSE THE DOOR REMOTELY, BUT THIS DID NOT WORK. PHYSICIAN WENT INTO ROOM AND MANUALLY DREW COUCH TO FINAL POSITION. PT WAS ESCORTED FROM ROOM, AND THE PHYSICIST RETURNED TO HYRDRAULIC ROOM AND USED THE LEVER TO CLOSE THE SHIELDING DOOR. CUSTOMER ATTEMPTED TO CLOSE THE DOOR REMOTELY, BUT THIS DID NOT WORK.
PT ADMITTED TO CRITICAL CARE UNIT IN RESPIRATORY DISTRESS AND REQUIRED INTUBATION. BAGGED BY RESPIRATORY THERAPY PRIOR TO INTUBATION. SWIVEL NECK CONNECTOR DOES NOT RELEASE EASILY FROM FACE MASK/BAG. THE STAFF HAD HAD A SIMILAR EXPERIENCE ON ANOTHER CODE BUT ATTRIBUTED IT TO A ONE TIME EVENT AND NO REPORT WAS GENERATED. WITH THE OCCURRENCE ON THIS CODE IT WAS FELT TO BE A DEFINITE PROBLEM. WHEN CONTACTING THE CO TO OBTAIN SHIPPING INSTRUCTIONS RPTR WAS TOLD THIS WAS A DESIGN CHANGE AND THAT FACILITY WOULD HAVE TO "ADAPT." WITH THE POTENTIAL FOR A SERIOUS INJURY BEING EXTREMELY HIGH IN A CRITICAL CODE SITUATION. IT IS NOT THE USER'S RESPONSIBILITY TO ADAPT. RPTR FEELS IT IS THE MFR'S RESPONSIBILITY TO PROVIDE SAFE EQUIPMENT FOR CODE SITUATIONS NO ONE APPARENTLY IN THIS MEDICAL CTR WAS NOTIFIED OF THIS DESIGN CHANGE OR THE NEED FOR INSERVICING.
NURSING DESCRIBED THE PROBLEM: AFTER SPIKING THE IV BAG, NURSE NOTICED TUBING WAS SPRAYING OUT OF SEVERAL HOLES MIDWAY UP LENGTH OF TUBING. IV BAG WAS CLAMPED ABOVE THE SITE. TUBING WAS DISCARDED AS IT CONTAINED BLOOD. NO PT HARM.
ARTERIAL LINE SALINE LOCK WON'T COME OFF.
PT TREATED IMPROPERLY FOR WART REMOVAL WITH A CRYOGENIC WART TREATMENT. PHYSICIAN DID NOT USE THE DEVICE ACCORDING TO THE PACKAGE INSERT. INSTEAD OF FREEZING THE APPLICATOR, THE PHYSICIAN SPRAYED CRYOGEN DIRECTLY ONTO THE PT'S SKIN. HEALTHY TISSUE BURNED.
DELAMINATION OF PATELLA POLY. DELAMINATION OF TIBIAL POLY. EXCESSIVE WEAR TO BOTH POLY SURFACES, REMOVED PATELLA AND INSERT AND REPLACED BOTH.
CLIENT RECEIVING DIALYSIS BEGAN COMPLAINING OF NAUSEA, NOT FEELING WELL, NURSE NOTED DIAPHORESIS, PALLOR AND SUSPECTED HYPOTENSION. OBSERVED TREATMENT PARAMETERS AND INDICATORS AS EXPECTED FOR THIS PART OF TREATMENT PER MONITORING SCREEN. INITIATED TREATMENT TO RESOLVE HYPOTENSION INCLUDING TRENDELENBURG POSITION AND NS BOLUS. NURSE OBSERVED CLEAR FLUID FLOWING OUT OF MACHINE AROUND THE BACK PANEL. REQUESTED ASSISTANCE OF EQUIPMENT AND TECH TO REMOVE PT FROM THE MACHINE. CLIENT WEIGHED AND FOUND TO BE 41 LBS LIGHTER THAN EXPECTED. TECH FOUND THE PRE UF PUMP ASSEMBLY HAD SEPARATED AND ALLOWED ULTRAFILTRATE AND DIALYSATE TO LEAK OUT OF THE MACHINE. MACHINE INVOLVED IS DUE FOR ANNUAL MAINTENANCE CHECK 8/96.
DR PLACED CO'S DEVICE. AFTER 2 1/2 MONTHS, THE RESTORATION FRACTURED AND IN THE PROCESS CRACKED THE PT'S REMAINING TOOTH STRUCTURE AT THE CREST OF THE BONE.
PT AND WIFE ALLEGE RECEIVING RASH FROM USING CO'S DEVICE. PT AND WIFE SEEN BY PHYSICIAN AND GIVEN OINTMENT FOR RASH. ADVISED TO STOP USING UNIT.
CUSHION SEALED MANUAL RESUSCITATION MASK DEFLATES OVER TIME WHICH RENDERS MASK INOPERABLE IF NOT REINFLATED. DESIGN OF MASK WITH PLASTIC PLUG INSTEAD OF A ONE WAY VALVE COULD HAVE POTENTIAL FOR ADVERSE EVENT AT TIME OF A RESUSCITATION EMERGENCY. MFR RECOMMENDATION IS TO REINFLATE MASK PERIODICALLY. ALSO, WHEN MASK DEFLATED, THE CUSHION SEAL MATERIAL BREAKS DOWN INTO A POWDERY SUBSTANCE AND RENDERS THE MASK INOPERABLE AND INCAPABLE OF REINFLATION.
LETTER FROM CHILD'S FATHER INDICATES THAT THERMOMETER'S TIP BROKE OFF INSIDE HIS DAUGHTER'S RECTUM. CHILD WAS TAKEN TO HOSP FOR X-RAYS.
THE INSERT PORTION AND METAL BACKED PATELLA WAS REMOVED DUE TO POLY WEAR AND REPLACED WITH A MEDIUM 9MM INSERT AND SMALL PATELLA.
WHILE PREPPING STENT DELIVERY SYSTEM IN PT, AIR WAS WITHDRAWN WHILE APPLYING NEGATIVE PRESSURE TO BALLOON. UNABLE TO INFLATE BALLOON TO COMPLETE PREP OR DEPLOY STENT. WHILE ATTEMPTING TO REMOVE SYSTEM AS A UNIT, STENT DEPLOYED AND EMBOLIZED TO RIGHT ILIAC ARTERY. STENT WAS RETRIEVED USING A GOOSENECK SNARE WITHOUT ADVERSE EVENT TO PT. THE PROCEDURE WAS EXTENDED BY APPROX 2 HRS. UPON REMOVAL OF THE DELIVERY SYSTEM IT WAS NOTED THAT THE STENT CASING WAS CRACKED AS IF FROM AGE OR DECAY. MFR WAS INFORMED OF EVENT AND DENIED ANY PRODUCT PROBLEM. THE MFR CLAIMED USER TECHNIQUE AS THE CAUSE OF THE EVENT. HOSP HAS DEVICE AVAILABLE UPON REQUEST.
PT PRESENTS WITH SPONTANEOUS DEFLATION OF RIGHT BREAST PROSTHESIS. HOLE FOUND PER DR.
REMOVED INSERT DUE TO POLY WEAR AND REPLACED.
PACKAGED SYRINGE DID NOT HAVE A CAP. CHIEF TECH REPORTS CO-WORKER PICKED UP THE PACKAGE AND WAS STUCK IN LEFT THUMB, REQUIRING MEDICAL INTERVENTION.
BREAST AUGMENTATION 1979. STARTED DEVELOPING CERVICAL AND LUMBAR BACK PAIN, RASHES, HEADACHES AND MUSCULOSKELETAL DISORDERS. NEUROLOGIST FEELS SOME OF HER PATHOLOGY MAY BE SECONDARY TO SILICONE IMPLANTS. AN MRI 1 YR AGO SHOWED LEFT RUPTURED IMPLANT. IMPLANTS SUBGLANDULARLY PLACED. PT STATED THEY WERE 220CC IN SIZE AT THE TIME OF EXPLANTATION - LEFT IMPLANT WAS INDEED RUPTURED. RIGHT IMPLANT INTACT BUT WITH SOME BLEEDING. BOTH IMPLANTS WERE SUBMUSCULAR AND LARGER THAN THE STATED 220CC SIZE.
FACILITY ALLEGES HEMOLYSIS. RN REPORTS APPX HALFWAY THROUGH 4 HR REATMENT PT COMPLAINED NOT FEELING WELL. BP 90/40. PT REQUESTED TO GO TO ER; COMPLAINED OF FEELING BLOATED; STATES NO BM FOR A WEEK. CLOTS ASPIRATED FROM ACCESS PRE-TREATMENT. BFR 400CC; VENOUS PRESSURE FLUCTUATED 90 TO 180. PT ADMITTED; HEMOLYSIS IDENTIFIED.
FACILITY ALLEGES HEMOLYSIS. RN REPORTS APPX 1.5 HRS INTO TREATMENT PT COMPLAINED OF FEELING BAD AND TREATMENT DISCONTINUED; PT ADMITTED TO HOSP. ADMITTING BLOODWORK WAS REPORTEDLY HEMOLYZED. REUSE #12; RENALIN.
HOME PT REPORTS NOT DRAINING ENOUGH TO GO INTO NEXT FILL. DRAINED OUT 1600 ML IN DRAIN 3 AND IS IN PAIN.
HOME CARE COORDINATOR ALLEGES SPLIT DRAIN BAG. EFFLUENT SPILLED TO FLOOR. PT DEVELOPED PERITONITIS 3 DAYS LATER.
DURING AN ANGIOPLASTY THE X-RAY IMAGING EQUIPMENT BECAME NON-FUNCTIONAL WITHOUT WARNING; ONLY TRANSIENT FUNCTIONING OF THE EQUIPMENT WAS ACHIEVED. AT THIS TIME INJECTIONS OF THE RIGHT CORONARY WITH 80-85% LESION, NO EVIDENCE OF DISSECTION. RECOVERY OF THE SYSTEM WAS NOT POSSIBLE. PT WAS OBSERVED. ABOUT 40 MINUTES POST INFLATION PT COMPLAINED OF CHEST PAIN. EKG SHOWED NO ABNORMALITY. CHEST PAIN CONTINUED DESPITE IV NITRO. PT TAKEN TO OR FOR BYPASS OF RIGHT CORONARY ARTERY.
ULTRASONIC PROBE TIP BROKE OFF DURING PROCEDURE AND WAS NOT RETRIEVED.
ANOTHER CO WAS INFORMED OF AN EXPLANT REPORT THAT THE SENSE PACE LEAD WAS  EXPLANTED FOR A SUSPECTED MALFUNCTION OF LOW INPEDENCE. THE LEAD WAS DAMAGED IN THE EXPLANT PROCEDURE AND WOULD NOT BE RETURNED FOR ANALYSIS. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORMED TO SPECIFICATION.
PHYSICIAN WAS DEPLOYING A STENT. WHILE POST-DILATING STENT, BALLOON FAILED TO DEFLATE. THE BALLOON HAD TO BE PULLED OUT OF THE RAMUS ARTERY WHILE INFLATED. THE STENT DISLODGED. IT DID NOT APPEAR TO BE IN THE RAMUS OR LEFT MAIN ARTERY AND ITS LOCATION WAS UNCERTAIN. THIS IS AN EXPERIMENTAL PRODUCT BEING TRACKED BY THE INSTITUTIONAL REVIEW COMITTEE. PT WAS DISCHARGED HOME ON 7/21/96 WITH NO APPARENT PROBLEMS.
LEAD WAS FOUND TO BE DEFECTIVE DURING IMPLANTATION. LEAD WAS REMOVED; RETIRED FROM SERVICE. NEW PACING LEAD WAS IMPLANTED IN PT.
PENILE PROSTHESIS IS NOT WORKING; PT WAS ADMITTED FOR OUTPATIENT SURGERY FOR REMOVAL OF NON-WORKING PROSTHESIS AND INSERTION OF NEW PROSTHESIS.
DURING CODE BLUE WHILE PUSHING EPINEPHRINE AND ATROPINE, IV TUBING BROKE 5 TIMES AT SITE WHERE TUBING IS INSERTED INTO THE MACHINE.
WHEN PUSHING IV MEDS AT LOWEST Y PORT, IV TUBING CAME APART AT UPPER PART OF TUBING, WHERE IT FITS INTO MACHINE.
WHILE ADMINISTERING AMP OF 50 % DEXTROSE IVP, IV TUBING BLEW APART.
THREE SEPARATE IV TUBINGS FELL APART WHILE PUSHING EMERGENCY DRUGS.
PT ARRESTED IN ROOM. DEFIBRILLATOR UNPLUGGED AND TAKEN INTO PT ROOM, DEFIBRILLATOR CHARGED TO 200J AND PT DEFIBRILLATED. DEFIBRILLATOR SET TO 300J AND ATTEMPTED TO RECHARGE. "LOW BATTERY" MESSAGE ACROSS DEFIBRILLATOR SCREEN AND WOULD NOT CHARGE TO 300J. DEFIBRILLATOR PROMPTLY PLUGGED INTO WALL OUTLET AND THEN CHARGED AND DELIVERED SEVERAL MORE DEFIBRILLATIONS WITHOUT FAIL. REMOVED UNIT FROM FLOOR. TESTED OUTPUTS; AT 200J OUTPUT WAS 196.5. CHANGED SELECTION TO 360J AND FIRED 4 TIMES CONSECUTIVELY. CHARGED AGAIN TO 360J TO OBTAIN MAX CHARGE TIME. UNIT CHARGED TO MAX IN 9 SECONDS AND DELIVERED 351.45. UNIT WAS ALLOWED TO SIT FOR APPROX 2 HRS UNPLUGGED FROM AC POWER. UNIT ONCE AGAIN WAS CHARGED TO 360 J. IT CHARGED IN 9 SECS AND DELIVERED 351.5 J. UNIT PERFORMED PERFECTLY DURING TESTING AND SHOWED NO SIGN OF BATTERY OR DISCHARGING PROBLEMS. REVIEW OF EQUIPMENT HISTORY SHOWS THAT UNIT HAS BEEN RETURNED TO CO 3 TIMES DURING LAST 12 MONTHS FOR VARIOUS PROBLEMS. (*)
ATRIAL PACING LEAD EXTRACTED FOR INSULATION FAILURE. LEAD WAS IMPLANTED ON 4/7/95 AT ANOTHER FACILITY.
VENTRICULAR PACING LEAD EXTRACTED FOR FRACUTRE. LEAD WAS IMPLANTED ON 4/7/95 AT ANOTHER FACILITY.
NURSE ATTEMPTED INSERTION UNSUCCESSFULLY. ANESTHESIOLOGIST INSERTED W/O DIFFICULTY LATER. AIR AUSCULATED OVER UPPER RIGHT ABDOMEN. FOLLOW-UP SHOWED RIGHT LUNG HAD 50% PNEUMOTHORAX.
FAILED PATELLA - LEFT TOTAL KNEE. TOTAL KNEE WAS IMPLANTED IN 1989 WITH PLASTIC SEPARATED FROM METAL. REPLACED PATELLA ON 7/17/96.
PT HAS BILATERAL CAPSULAR CONTRACTURE WITH A LEFT RUPTURED IMPLANT. BILATERAL IMPLANTS WERE REMOVED AND REPLACED.
BLOOD WAS NOTED IN THE IABP CATHETER TUBING AT 1530 ON 7/10/96. THE PHYSICIAN WAS NOTIFIED IMMEDIATELY. ON 7/11/96, THE PT WAS WEANED FROM THE IABP AND THE PHYSICIAN ORDERED THE DISCONTINUANCE OF THE BALLOON. THE CATH LAB TECH FELT RESISTANCE WHILE ATTEMPTING TO DISCONTINUE THE BALLOON. THEREFORE, THE PHYSICIAN WAS NOTIFIED. WHEN HE DISCONTINUED THE BALLOON, PART OF THE CATHETER WAS LEFT IN THE LEG. THE PT WAS IMMEDIATLEY TAKEN TO THE CARDIOVASCULAR OR (CVOR) WHERE THE CATHETER AND CLOTS WERE REMOVED SUCCESSFULLY.
ABG BLOOD GAS DRAWN ON 7/12/96 INDICATED ELEVATED PO2. ON INVESTIGATION OXYGEN BLENDER DIAL READ .21 WITH A FLOW OF 0.5 LPM. THE NASAL CANNULA WAS ANALYZED AND READ 40% OXYGEN. AN INVESTIGATION OF DEVICE ON 7/18/96 BY THE MFR SHOWED THIS HIGH FLOW RATE BLENDER TO BE ERRATIC IN PERFORMANCE WHEN USED TO DELIVER A LOW FLOW RATE. WEIGHT 819 GM.
CUSTOMER REPORTS LACERATIONS IN PT'S THROATS WHICH ARE BELIEVED TO BE CAUSED BY NASOGASTRIC TUBE. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT. DISTRIBUTOR CANNOT DETERMINE WHETHER THIS PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT.
THE IMAGE DARKENED AND THEN BLACKED OUT DURING COLONOSCOPY CAUSING THE PROCEDURE TO BE COMPLETED WITH A SECOND SCOPE AND THERE WERE NO PT INJURIES. THE DARKENING OF THE IMAGE COULD NOT BE CONFIRMED DURING THE INITIAL INVESTIGATION BY CO.
LEAD WAS EXPLANTED ON 7/16/96, DUE TO AN INSULATION BREAK. AS OF TODAY 7/22/96, THE LEAD HAS NOT BEEN RETURNED TO CO. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORM TO SPEC.
TIP BROKE OFF IN PT. PRODUCT PREVIOUSLY USED AND HAD BEEN RESTERILIZED.
DURING REMOVAL, THE TIP BROKE OFF OF THE DRAIN AND REMAINED IN THE PT. THE TIP WAS SURGICALLY REMOVED THE FOLLOWING DAY.
LEADS WERE CAPPED ON 7/9/96, DUE TO NOISE WHICH CAUSED INAPPROPRIATE SHOCKS. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORM TO SPEC.
CUSTOMER REPORTS THAT WHILE EXAMINING A BABY, A PHYSICIAN FOUND A STIFF, BLACK, HAIR-LIKE ITEM PROTRUDING FROM THE BABY. CUSTOMER WAS NOT ABLE TO CONFIRM IF THIS ITEM CAME FROM THE DIAPER. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT. DISTRIBUTOR CANNOT DETERMINE WHETHER PRODUCT INVOLVED IN THIS REPORT CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT.
ON 7/15/96, THE EMT SVC FROM THE MED CTR WAS SUMMONED TO A CARDIAC ARREST. FOLLOWING THEIR PROTOCOL THEY ATTACHED THE CO AED TO THE PT. THEY GOT AN INITIAL RHYTHM OF VENTRICULAR FIBRILLATION ON THE OSCILLOSCOPE. THEY ATTEMPTED TO ANALYZE BUT GOT A CHECK ELECTRODE MESSAGE. WITH HAND PRESSURE ON THE ELECTRODE PADS, THEY AGAIN GOT A BRIEF RHYTHM. HOWEVER, THEY COULD NOT MAINTAIN ELECTRODE CONTACT LONG ENOUGH TO ALLOW THE MACHINE TO ANALYZE. THE ELECTRODE PADS WERE CHANGED. THERE WAS NO IMPROVEMENT IN RHYTHM DETECTION. THE EMT'S COULD NOT DEFIBRILLATE ON SCENE BECAUSE OF THIS MALFUNCTION. FOLLOWING THE CONCLUSION OF THE RESUSCITATION EFFORT THE FOLLOWING WERE CHECKED: THE OUTDATES ON THE ELECTRODE PADS WAS 7/97. PLACING A NEW SET OF PADS ON A VOLUNTEER AND USING THE SAME MONITOR, CABLE, AND PERSONNEL, THE PROBLEM COULD NOT BE REPRODUCED. CONVERSATION WITH THE MFR LEAD TO NO OBVIOUS CONCLUSION. THE UNIT WAS TAKEN OUT OF SVC AND RETURNED TO THE MFR FOR ANALYSIS.
STAPLER HANDED TO SURGEON WITH NO STAPLES. STAPLER WAS USED AND RESULTED IN MORE RESECTION OF BOWEL. DR HAD TO REDO ANASTOMOSIS WHICH INCREASED OR TIME BY 1 HR.
PT S/P ANTERIOR WALL MI - HAVING A CORONARY ANGIOGRAM AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. GUIDING CATHETER WAS INSERTED INTO THE AORTA TOWARD LEFT CORONARY ARTERY. APPROX 1MM FRAGMENT WAS NOTED MISSING FROM TIP OF CATHETER - LODGED IN A VERY SMALL BRANCH IN CIRCUMFLEX SYSTEM (SEEN ON FLUOROSCOPY) - PT ASYMPTOMATIC, FRAGMENT APPEARS LODGED SECURELY. MD DOES NOT ANTICIPATE ANY PROBLEM.
PT WENT INTO CODE STATUS AND WAS REVIVED. PHYSICIAN WHO WAS CODE CAPTAIN INDICATED THAT A TUBE APPEARED TO BE DISCONNECTED FROM THE PT'S VENTILATOR. WHEN THE TECH DISCONNECTED THE TUBE TO CHECK FOR PROPER FUNCTION, THE ALARM SOUNDED AS IT SHOULD HAVE IF MALFUNCTION OCCURRED. INVESTIGATION IS CONTINUING.
NURSE REPORTS THE FOLLOWING SYMPTOMS AS A RESULT OF REPEATED GLUTARALDEHYDE STERILIZING AGENT EXPOSURE: MIGRAINES, COLITIS, FATIGUE, WEAKNESS, BLOATING, EDEMA, BURNING EYES, NOSE AND FACE, MUSCLE SPASMS, CHOKING, LARYNGOSPASM, NASAL CONGESTION, SOB, "HUSKY" VOICE, DIZZINESS, DIFFICULTY BREATHING, "UPPER AIRWAY CLOSED," INFLAMMED EDEMATOUS VOCAL CORDS, "VIRAL-LIKE" SYMPTOMS, AND WAS DIAGNOSED BY SEVERAL PHYSICIANS WITH ASTHMA AND "HYPERACTIVE AIRWAY 'DISEASE' AS A RESULT OF GLUTARALDEHYDE SENSITIVITY." THIS SENSITIVITY WAS DOCUMENTED BY A POSITIVE CARBACHOL CHALLENGE TEST. RPTR ALSO NOTES HARASSMENT BY HOSP STAFF REGARDING WORKMAN'S COMPENSATION ISSUES AND INEFFECTIVE REGULATION BY GOVERNMENT AGENCIES. RPTR ALSO SITES SIMILAR MEDICAL PROBLEMS AMONG NUMEROUS CO-WORKERS. (*)
LEAK IN DISPOSABLE TUBING WITH POSSIBLE CONTAMINATION OF THE PT LINE. ANESTHESIOLOGIST WAS USING A BLOOD PUMP ABOVE THE TUBING SET. HE WAS USING THE HAND PUMP TO DELIVER PUMP BLOOD TO THE PT WHEN THE TUBING SET IN THE FLUID WARMER STARTED TO LEAK BLOOD INTO AND OUT OF THE UNIT ONTO THE FLOOR. THE FLUID WARMING SET WAS TAKEN OUT OF THE PT'S IV LINE. ANOTHER FLUSHED WITH NORMAL SALINE AND RETURNED TO THE MFR.
PUMP SET AT 55CC PER HOUR APPEARS TO HAVE GIVEN 100CC PER HOUR. PT RECEIVED 300CC TPN/2 3/4 HRS INSTEAD OF 170CC.
ON COMPLETION OF PHLEBOTOMY, RN ATTEMPTED TO PULL SAFETY SHEATH TO COVER NEEDLE. IT WOULD NOT SLIDE OVER THE NEEDLE AND NEEDLE STICK OCCURRED DURING THE ATTEMPT.
ENDODONTIC FILE LABELED 21 MM BUT CONTAINS 25 MM LENGTH FILES.
PT SLID DOWN FROM THE MATTRESS OVERLAY WHILE LYING IN BED (WITH FOUR SIDERAILS; TWO TOP RAILS UP). PT WAS FOUND SITTING ON FLOOR NEXT TO BED; NO INJURY SUSTAINED. IT SHOULD BE NOTED THAT THERE IS MINIMAL CLEARANCE (APPROX 3 INCHES) BETWEEN TOP OF BEDRAIL IN UP POSITION AND THE OVERLAY MATTRESS. THE HOSP HAS DISCONTINUED USE OF THESE OVERLAYS.
RPTR ATTEMPTED ON 6/3/96 TO INSERT A BILIARY STENT 10MM,68MM. THE STENT WAS PROPERLY PRIMED WITH SALINE, THE GUIDE WIRE WAS IN PLACE, THE STENT WAS PUT INTO POSITION, BUT IT WOULD NOT DEPLOY, THE VALVE BODY WOULD NOT SLIDE UP THE STEEL TUBE. RPTR WAS ABLE TO INSERT A REGULAR STENT WITH LITTLE DIFFICULTY. OUTSIDE OF THE PT THE STENT WOULD NOT DEPLOY EITHER, BUT THE VALVE BODY DID SLIDE UP AND DOWN THE STEEL TUBE WITHOUT ANY PROBLEM.
DUE TO AN AUTO ACCIDENT RPTR WAS TOLD BY THE DR TO GET A MRI OF THE NECK. RPTR HAD A MILD CASE OF TINNITUS IN HER LEFT EAR. RPTR WAS NOT GIVEN ANY EAR PLUGS; ONLY ASKED IF SHE HAD A PACEMAKER. AFTER THE TEST RPTR CAME OUT OF THE MACHINE FEELING DIZZY AND NAUSEATED. RPTR NOW HAS TINNITUS IN HER RIGHT EAR AS WELL WHICH MAKES LIVING VERY, VERY DIFFICULT.
PT CODED IN PRIVATE VEHICLE ON WAY TO HOSP. THE INITIAL EKG MONITOR APPEARED TO BE A STRAIGHT LINE WITH SOME MOTION. PT WAS DELIVERED 360 JOULES OF DEFFIBRILLATION FOLLOWING WHICH THE MONITOR SHOWED A PERFECTLY STRAIGHT LINE. THE MONITOR LEADS WERE IMMEDIATELY DISCONNECTED FROM MONITOR AND CONNECTED TO SECOND MONITOR WHICH SHOWED A STRAIGHT LINE WITH SOME MOTION. IN NO WAY WAS PT CARE COMPROMISED IN THIS INSTANCE. PT WAS ESSENTIALLY DEAD ON ARRIVAL TO FACILITY. WHEN CO WAS NOTIFIED, THEY STATED THAT THERE HAD BEEN A RECALL OF THIS MONITOR FOR THIS PROBLEM. THERE IS NO INDICATION OF RECALL NOTIFICATION TO FACILITY.
SEEN ON OFFICE VISIT. NECROTIC TISSUE RIGHT BREAST. HAS EXPANDABLE SALINE BREAST IMPLANT.
CARDIAC ARREST-ATTEMPTED TO PACE WITH UNIT AND PACER WOULD NOT FIRE. MONITOR SHOWED ECG. FAILURE TO CORRECTLY SET EQUIPMENT.
ON 4/9/96, THE CATARACT EXTRACTOR FAILED TO GENERATE VACUUM DURING A CATARACT PROCEDURE. THE UNIT EXHIBITED PROBLEMS WITH VACUUM, SUCTION AND COULD NOT BE RELIED UPON TO WORK CONSISTENTLY.
ONSET OF BLEEDING NOTED AT INSERTION SITE. UPON INVESTIGATION IT WAS NOTED THAT CATHETER WAS SEPARATED FROM HUB. CATHETER COULD NOT BE DISLODGED, NECESSITATED SURGICAL REMOVAL.
ON 4/9/96, THE CATARACT EXTRACTOR UNIT FAILED TO GENERATE VACUUM DURING A CATARACT PROCEDURE. THE UNIT EXHIBITED PROBLEMS WITH VACUUM, SUCTION AND COULD NOT BE RELIED UPON TO WORK CONSISTENTLY.
AFTER PT-EXPIRED, PACEMAKER PATCHES WERE (EXTERNAL) REMOVED AND 4 NICKEL AND QUARTER SIZED BURN AREAS FOUND ON SKIN. PACER HAD BEEN AT MAXIMUM  MA FOR 8 HOURS. BURN AREAS WITH BROWN RIMS AND WHITE CENTERS. (NECROTIC).
LEFT THIGH NOTED TO BE VERY REDDENED IN RECOVERY ROOM. SITE NOTED AS THE SAME AS BOVIE PAD PLACEMENT. AREA SITE IMPROVED IN THE HOUR HOWEVER STILL VERY REDDENED AT ONE SPOT.
LEAK OF RIGHT TISSUE EXPANDER. INSERTION DATE NOTED OF 3/96.
CORNEAL DECOMPOSITION REQUIRING CORNEAL TRANSPLANT.
CATHETER WAS BEING STRIPPED IN RADIOLOGY BECAUSE OF FIBRIN SHEATH SURROUNDING BOTH PORTS WHEN CATHETER TIP BROKE OFF AND BECAME LODGED IN PULMONARY ARTERY. PIECE COULD NOT BE RETRIEVED. PT WAS ASYMPTOMATIC. CATHETER WAS INSERTED VIA INTERNAL JUGULAR APPROACH. INSERTED IN ANOTHER FACILITY APPROX. 3 WEEKS PRIOR TO EVENT.
WHILE LAPAROSCOPIC HERNIA REPAIR SURGERY WAS TAKING PLACE THE DR NOTICED A  BLACK CONE SHAPED PIECE OF RUBBER IN THE ABDOMINAL CAVITY. THE DR WAS ABLE TO RETRIEVE THE OBJECT AND REMOVE IT FROM THE ABDOMINAL. THE CONE SHAPED OBJECT CAME FROM THE PRODUCT WHERE THE ARM MEETS THE HANDLE.
WHILE RESIDENT WAS BEING WHEELED BY NURSING ASSISTANT, THE WHEELS BEGAN TO  SHAKE. (THE FRONT WHEELS ARE MADE OF PLASTIC.) THE SPOKES OF BOTH WHEELS COLLAPSED CAUSING RESIDENT TO FALL OUT OF WHEELCHAIR AND THE NURSING ASSISTANT TO FALL OVER WHEELCHAIR. RESIDENT RECEIVED LACERATIONS TO LEFT AND RIGHT HAND KNUCKLES AND A CUT TO RIGHT EYE REQUIRING 4 SUTURES. EMPLOYEE SUSTAINED A SPRAINED ANKLE.
PT UNDERWENT AN ULTRASOUND GUIDED IMPLANT FOR RECURRENT PROSTATE CANCER AFTER EXTERNAL RADIATION GIVEN IN 1989. THE RECURRENT CANCER WAS ROCK-HARD AND PARTIALLY ENVELOPED THE RECTUM. THE ULTRASOUND TECH HAD TO INFLATE THE BALLOON ON THE RECTAL PROBE WITH MORE PRESSURE THAN USUAL BECAUSE OF THE FIXATION OF THE PROSTATE TO ELEVATE IT TO A POSITION TO ENABLE IMPLANTATION OF THE PALLADIUM SEED, APPARENTLY CAUSING A TEAR IN THE RECTUM ABOVE THE PERITONEAL REFLECTION, THUS ALLOWING RECTAL CONTENTS INTO THE PELVIC AND ABDOMINAL CAVITY. A TEMPORARY COLOSTOMY WAS PERFORMED ON JULY 4TH, 1996 AND REVISED ON 7/8/96.
DR HAD ALREADY MILLED THE FEMUR, BUT FOUND A ROUGH SPOT THAT NEEDED TO BE  SMOOTHED. HE PUT THE MILLING GUIDE BACK ON AND CONTINUED TO FINISH MILLING. ONE OF THE NURSES WAS RETRACTING A PIECE OF SKIN WITH HER FINGERS. THE SKIN SLIPPED FROM HER FINGERS. SHE WENT TO RETRIEVE THE SKIN AND PUT HER HAND UNDER THE MILLING DRAPE. THE MILLING BUR CAUGHT HER FINGER AND TORE THE SKIN OFF OF HER INDEX FINGER.
FACILITY ALLEGES BLOOD LEAK. RN REPORTS LEAK OCCURRED AT HOOK UP. EBL > 100CC.
SURGEON REOPERATED DUE TO RUPTURE OF PATELLA TENDON. REMOVED AND DID NOT REPLACE PATELLA. REPLACED DELAMINATING INSERT WITH 9MM MACHINED SMALL RIGHT.
CEMENT LOOSENING AROUND PROSTHESIS. REMOVED HIP IMPLANT AND REIMPLANTED LONGER CEMENTED STEM. REPLACED INSERT BECAUSE THEY WERE THERE.
AN INCIDENT OCCURRED INVOLVING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACED IN A CEREBRAL VASCULAR ACCIDENT PT. THE PEG WAS INSERTED ON 7/24/96. ON 7/27/96 THE PT WAS TAKEN TO SURGERY FOR REMOVAL OF THE FEEDING TUBE. THE INTERNAL BOLSTER WAS EMBEDDED IN THE ABDOMINAL WALL. THE PT WAS HAVING INTERNAL BLEEDING AND DEVELOPED PERITONITIS. ANOTHER TUBE WAS NOT PLACED AND THE PT IS STABLE. NO FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT ARE AVAILABLE.
AN INCIDENT OCCURRED INVOLVING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACED IN A CEREBRAL VASCULAR ACCIDENT PT. THE PEG WAS INSERTED ON 7/19/96. ON 7/26/96 THE PT EXPERIENCED GI BLEEDING. AN ENDOSCOPY WAS PERFORMED AND IT WAS NOTED THE INTERNAL BOLSTER HAD ERODED INTO THE ABDOMINAL WALL. A BLEEDING ULCERATED AREA AT THE SITE OF EROSION WAS NOTED. THE FEEDING TUBE WAS REMOVED ENDOSCOPICALLY. A G-TUBE WAS PLACED AND THE BALLOON WAS USED TO TAMPONADE THE BLEED. THE PT'S CONDITION AFTER MEDICAL TREATMENT WAS REPORTEDLY GOOD. NO FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT ARE AVAILABLE.
A RENAL ANGIOGRAM WAS PERFORMED WITHOUT INCIDENT AND THE PT WAS TRANSFERRED TO HIS ROOM. BLEEDING WAS NOTED AT THE INSERTION SITE. THE DRESSING WAS LIFTED AND IT WAS NOTED THE INTRODUCER SHEATH WAS CRACKED. THE SHEATH WAS REMOVED AND THE PT'S HEART RATE DECREASED. MEDICATION AND FLUIDS WERE  ADMINISTERED AND NO FURTHER PT COMPLICATIONS ENSUED.
DURING A BLADDER STONE REMOVAL PROCEDURE, THE TIP OF THE PROBE BROKE OFF AND THE UNIT SMOKED AND STOPPED FUNCTIONING. PROCEDURE WAS ABANDONED AND PT WAS RESCHEDULED ON 6/27. THE REMAINING STONES AND THE PROBE TIP WERE REMOVED ON 6/27/96.
PT REPORTEDLY IN HOSP WITH PERITONITIS; HAS BEEN HAVING TROUBLE USING THE DEVICE. SERVICE TECH REPORTS CYCLER DID NOT CAUSE OR CONTRIBUTE TO PERITONITIS; HOWEVER, UNABLE TO REACH PT TO DETERMINE WHETHER PERITONITIS EXISTED AT THE SAME TIME AS THE TROUBLE WITH CYCLER. FILED CONSERVATIVELY AS DISTRIBUTOR REPORT.
DURING TREATMENT OF PT, OXYGEN CYLINDER VALVE WAS TURNED ON BY FIRE FIGHTER. FLASH FIRE OCCURRED WITH SEVERE DAMAGE TO REGULATOR BODY. FIRE FIGHTER SUFFERED 3RD DEGREE BURNS TO LEFT HAND AND ARM. CYLINDER-D SIZE ALLUMINUM REGULATOR - ALUMINUM BODY. NO SOURCE OF IGNATION FOUND AT SCENE.
NO LUMEN/HOLE AT END OF CATHETER. INSERTED INTO BLADDER; THEREFORE, COULD NOT BE IRRIGATED AND COULD NOT DRAIN URINE. THIS PROBLEM WAS FOUND WHEN CATHETER WAS CHANGED DUE TO NO URINE OUTPUT AND COULD NOT BE SURE IT WAS IRRIGATED WELL.
INFUSOR STOPPED RUNNING WITHIN 24 DEGREES. ADD'L EVENT DATE 6/11.
THE INJECTION PORT OF THE RUBBER STOPPER IS DETERIORATED. THE BOX IS NEW AND WAS NOT EXPOSED TO LIGHT.
AUTOCLAVE, HAS CAUSED INJURIES TO A PT OF AN EYE CENTER. UPON INVESTIGATION, DISTRIBUTOR FOUND THAT OVER TIGHTENING OF DOOR LOCKING DEVICE CAUSED THE DOOR TO POP OPEN APPROX. 1/8" AND ALLOW STEAM TO ESCAPE THROUGH THIS SPACE. IN THIS CASE, THE SAFETY LATCH FUNCTIONED PROPERLY, AS DESIGNED, PREVENTING THE DOOR FROM OPENING ANY FURTHER.
INFUSOR STOPPED RUNNING WITHIN 24 DEGREES. ADD'L EVENT DATE 7/30.
CO USED TO HAVE DRAIN BAGS OF 15 LITER SIZE WHERE TWO COULD BE CONNECTED TOGETHER FOR A TOTAL OF 30 LITER DRAINAGE DURING DIALYSIS TREATMENT. THE CO CHANGED THE DESIGN OF THE BAG AND DID NOT NOTIFY PTS OR FACILITY. THE NEW BAGS ARE OF 20 LITER SIZE AND ONE CANNOT BE CONNECTED TO ANOTHER. SOME PTS MISSED THEIR DIALYSIS TREATMENT WHEN THEY FOUND OUT THE BAGS ARE OF 20 LITER SIZE AND THEY DRAIN MORE THAN THAT. ACCORDING TO REPORTER, ABOUT 25 PTS WERE INVOLVED. RPTR RECEIVED NUMEROUS CALLS FROM PTS REGARDING THIS CHANGE. EVEN WHEN RPTR CALLED THE CO TO INQUIRE ABOUT THE CHANGE IN PRICE OF THESE BAGS, SHE WAS NOT INFORMED OF THE SIZE CHANGE.
THE GROUNDONG PIN ON THE TRANSCUTANEOUS MONITOR POWER TRANSFORMER HAD BROKEN LOOSE FROM THE MOUNTING BASE OF THE TRANSFORMER AND CAME IN CONTACT WITH THE A.C. POWER PINS. THIS CAUSED THE PTS' HEAD WALL CIRCUIT BREAKER TO LOSE ALL ELECTRICAL POWER. THERE WAS NO CHANGE IN STATUS OF THE PT.
IV START KIT CONTAINED LONG BLACK HAIR INSIDE PACKAGE. THE HAIR WAS NOTICED BEFORE PACKAGE WAS OPENED. ITEMS IN PACKAGE ARE SUPPOSED TO BE STERILE. THE PROBLEM WAS FOUND DURING A DISCUSSION ON STERILE TECHNIQUE TO NEW HOSP EMPLOYEES.
BROKEN TITANIUM FIXATION SCREW SECURING A PIECE INTO A DENTAL IMPLANT.
AS DEVICE WAS BEING USED BY GYN SURGEON, SMALL GREEN MATERIAL AROUND END OF NEEDLE APPEARED TO "MELT" AND REMAINED IN RIGHT SIDE OF PELVIC CAVITY WHEN DEVICE WAS WITHDRAWN. FOREIGN BODY RETRIEVED BY SURGEON WITH GRASPER. NO INJURY TO PT.
CONFUSED RESIDENT WAS IN BED WITH 1/2 SIDE RAILED UP. SHE BENDS TO TURN OR ROLL IN BED FREQUENTLY. SHE TURNED TOWARD THE RAIL AND HER HEAD BECAME ENTANGLED IN THE BARS AND HER TRUNK AND FEET WERE TANGLED IN HER SHEET AND WERE OVER THE SIDE OF THE BED AND ON THE FLOOR. RES. WAS BLUISH AND COOL. STAFF HAPPENED TO GO BY ROOM AND FOUND HER. SHE WAS ASSISTED BACK INTO BED, COLOR RETURNED.
CAP INSERTED INTO CATHETER WITH ANTIBIOTIC INFUSED AND MIDDLE PART OF CONNECTOR STAYED IN CATHETER WHEN CAP REMOVED. 3 PEOPLE TRIED TO GET PIECE OF CAP OUT, FINALLY SUCEEDED.
CONSUMER'S HANDS BECAME ITCHY. WHEN SHE TOOK HER GLOVES OFF, RED HIVES WERE ALL OVER HER HANDS. SHE WENT TO SEE DR ON 4/96 TO GET SKIN TESTED. CONSUMER WAS DIAGNOSED AS BEING ALLERGIC TO LATEX.
LEFT IMPLANT DEFLATED WHEN REMOVED. RIGHT IMPLANT INTACT WHEN REMOVED. LEFT IMPLANT ORIGINAL IMPLANT PUT IN 11/13/75. RIGHT IMPLANT REMOVED AND REPLACED 3/11/85. RIGHT IMPLANTED 3/11/85.
NURSE HAD ANOTHER NURSE PLACE CATHETER FOR TRAINING PURPOSES. NURSE #2 DEVELOPED SMALL HIVE APPROX 2CM NEAR INSERTION SITE AFTER CATHETER INSERTED AND FLUSHED. NURSE ALSO C/O HEADACHE, NECK PAIN AND TACHYCARDIA. NURSE HAS LATEX SENSITIVITY. NURSE INSERTING CATHETER WAS WEARING LATEX GLOVES WITH NORMAL SALINE FLUSH, HAS A LATEX SEPTUM ON VIAL.
NURSE IN CLASS TO LEARN IV INSERTIONS OF CATHETER INTO NURSE #1 L ARM. NURSE C/O "FEELING FUNNY" DURING INSERTION AND FLUSH. C/O SORE THROAT, "CLOSING FEELING OF THROAT," HAD LUMP IN R SIDE OF HEAD "ULCER DEVELOPED IN MOUTH," C/O SOB. CATHETER REMOVED, EPINEPHRINE GIVEN AND NURSE SENT TO ER. ALL SX RESOLVED. WAS GIVEN BENADRYL AND SENT HOME. NURSE HAS HX OF LATEX SENSITIVITY, RN INSERTING CATHETER HAD LATEX GLOVES ON, NS USED, FLUSH HAS LATEX SEPTUM.
20G MIDLINE CATHETER WAS INSERTED INTO L ARM CEPHALIC VEIN ON 1ST ATTEMPT AND ADVANCED 8". PT OFFERED NO C/O UNTIL CATHETER WAS FLUSHED WITH 10CC BACTERIOSTATIC NACL; THEN PT C/O TINGLING IN FACE HANDS AND C/O NAUSEA WITH SUBSEQUENT VOMITING. VOMITED 40CC CLEAR SOLUTION, BP=80/40 P-118. DR CAME IN TO ASSESS PT. SHE C/O FEELING COLD. STAT FINGERSTICK GLUCOSE = 40. BP 80/40 50CC OF D50 GIVEN IVP AND 500CC .9NS @ WIDE OPEN RATE. 30 MINS INTO EVENT BP=90/50. 50MG BENADRYL GIVEN. BP WAS THEN 120/60. FINGERSTICK GLUCOSE=440. 1 DEGREE LATER CATHETER WAS DISCONTINUED AND 24G CATHETER WAS PLACED. PT WAS TRANSPORTED TO HOSP FOR OVERNIGHT EVALUATION. SHE WAS DISCHARGED TO HOME 6/28/96 WITH CATHETER IN PLACE AND WENT HOME TO INFUSE IV OFLOXCIN Q12H.
POSTOPERATIVELY, PT REPORTED AWARENESS AND PAIN DURING GENERAL ANESTHESIA FOR UMBILICAL HERNIA REPAIR. (PROCEDURE TIME: 25 MIN). INVESTIGATION FOUND FORANE VAPORIZOR NOT COMPLETELY SEATED AND LOCKED TO ANESTHESIA MACHINE MANIFOLD. OXYGEN NITROUS OXIDE, AND VAPORIZOR. AGENT MIXTURE WAS DILUTED WITH AIR INTRODUCED THROUGH VAPORIZOR - MANIFOLD LEAK. INVESTIGATION DETERMINED THE VAPORIZOR LOCK DOWN BOLT (ZEUS FASTENER) WAS BENT AND COULD NOT PROPERLY ATTACH TO VAPORIZOR MANIFOLD FIXTURE.
EXTERNAL PACING CASSETTE INTERMITTENTLY STOPPED PACING. PT BRADYCARDIC AT RATE OF 10 BPM. CPR HAD TO BE INITIATED DUE TO PACER FAILURE. BACK UP CASSETTE FROM ICU OBTAINED AND USED WITH SUCCESS IN SAME DEFIBRILLATOR/MONITOR.
VENTILATOR DID NOT DELIVER SET TIDAL VOLUMES NOR PROPER RATE. HEARD VENTILATOR TICKING AND THEN DELIVERED NO TIDAL VOLUME. VENTILATOR ALARMS STATED NO TECHNICAL ERROR. PT AMBUED AT BEDSIDE TILL NEW VENTILATOR ARRIVED. NO SERIOUS INJURY/ILLNESS/DEATH RESULTED IN THIS EVENT.
THE PT IS A 30-YR-OLD MARRIED CAUCASIAN FEMALE WHO HAD A CATHETER INSERTED APPROX FOUR WEEKS AGO. SINCE THEN, THEY HAVE BEEN HAVING A DIFFICULT TIME WITH LEAKAGE OF THE ARTERIAL SIDE OF THE CATHETER AS WELL AS THE SLUGGISH VENOUS SIDE OF THE CATHETER. THIS MORNING THE PT FOUND OUT THAT WHILE SHE WAS ASLEEP OVERNIGHT THE VENOUS SIDE OF THE CATHETER COMPLETELY FELL OUT. ON EXAMINATION OF THE CATHETER THAT SHE BROUGHT WITH HER, THE COMPLETE LENGTH OF THE VENOUS CATHETER WAS FOUND WITHOUT THE DACRON CUFF AT THE 22CM LENGTH IN COMPARISON TO THE INTACT NEW CATHETERS.
PT SEEN FOR MONTHLY PAC FLUSH.  PT REPORTED "STINGING" WHEN ABOUT 5CC NS HAD BEEN INJECTED.  REPOSITIONED NEEDLE AND RESUMED FLUSH, EDEMA NOTED OVER SITE.  PHYSICIAN OFFICE NOTIFIED AND PT WAS INSTRUCTED TO MAKE APPT.  FOLLOW-UP PHONE CALL TOPT AT END OF JUNE REVEALED THAT PT HAD PORT REMOVED.  PER PT "I WAS TOLD BY MY DOCTOR THAT THE PORT WAS IN PIECES".
SMALL DARK REDDISH BROWN PARTICULATE NOTED INTERIOR OF FLUID CHAMBER.
PT UNDERGOING AN ENDOMETRIAL ABLATION THROUGH A HYSTEROSCOPE. AT END OF PROCEDURE A SEVERE BURN WAS IDENTIFIED EXTENDING THE ENTIRE LENGTH OF THE ANTERIOR VAGINAL WALL. BLISTERS WERE IDENTIFIED NEAR THE CERVICAL OS AND CERVIX ALSO HAD SOME BLANCHING. ALL EQUIPMENT INSPECTED PRIOR TO USE. NO DEFECTS ON MALFUNCTION NOTED. GROUNDING AND SENSING PAD IN FULL CONTACT AND NO ALARMS WERE SOUNDING. HAVE NOT BEEN ABLE TO IDENTIFY A SOURCE OR REASON FOR THE BURN OTHER THAN THE FACT THAT LUBRICANT WAS USED IN THIS CASE TO DILATE CERVIX. LUBE USED WAS THE ONLY VARIABLE AND HAS NOT BEEN USED IN INSTUTUTION FOR THIS PROCEDURE IN THE PAST. ALTHOUGH LUBE COMMONLY USED IN CAUTERY PROCEDURES AND THERE HAS NEVER BEEN A CONTRAINDICATION OR WARNING REGARDING LUBRICANT LUBE AND THIS HYSTEROSCOPE TO RPTR'S OVERKNOWLEDGE. ALL STAFF DOING PROCEDURE TRAINED BY MFR AND LUBE HAS NEVER BEEN IDENTIFIED WITH A WARNING.
20 GAUGE CATHETER INSERTED AND WHILE REMOVING GUIDE WIRE, THE WIRE FOUND TO BE STRETCHING. NO RESISTANCE FELT DURING REMOVAL. UPON EXAMINATION WIRE AT CENTER PORTION THINNED AND STRETCHED. BOTH ENDS OF GUIDE WIRE WITHOUT INDICATION OF STRETCHING.
PT PRESENTED TO ER WITH COMPLAINT OF BILATERAL HAND RASH. SOME RASH ON NECK. PT HAD USED NEW SOAP PREVIOUS DAY AND HAD ALSO WORN LATEX GLOVES (NURSING STUDENT). TREATED WITH BASIS SOAP PRN 3/5/96, HYDROXYZINE 10MG TID 3/5/96, HYDROCORTISONE CREAM 18 PRN ITCHING.
NURSE REPORTS THE FOLLOWING SYMPTOMS AS A RESULT OF REPEATED GLUTARALDEHYDE STERILIZING AGENT EXPOSURE: MIGRAINES, COLITIS, FATIGUE, WEAKNESS, BLOATING, EDEMA, BURNING EYES, NOSE AND FACE, MUSCLE SPASMS, CHOKING, LARYNGOSPASM, NASAL CONGESTION, SOB, "HUSKY" VOICE, DIZZINESS, DIFFICULTY BREATHING, "UPPER AIRWAY CLOSED," INFLAMED EDEMATOUS VOCAL CORDS, "VIRAL-LIKE" SYMPTOMS, AND WAS DIAGNOSED BY SEVERAL PHYSICIANS WITH ASTHMA AND "HYPERACTIVE AIRWAY 'DISEASE' AS A RESULT OF GLUTARALDEHYDE SENSITICVITY." THIS SENSITIVITY WAS DOCUMENTED BY A POSITIVE CARBACHOL CHALLENGE TEST. RPTR ALSO NOTES HARASSMENT BY HOSP STAFF REGARDING WORKMAN'S COMPENSATION ISSUES AND INEFFECTIVE REGULATION BY GOVERNMENT AGENCIES. RPTR ALSO SITES SIMILAR MEDICAL PROBLEMS AMONG NUMEROUS CO-WORKERS. (*)
NURSE REPORTS THE FOLLOWING SYMPTOMS AS A RESULT OF REPEATED GLUTARALDEHYDE STERILIZING AGENT EXPOSURE: MIGRAINES, COLITIS, FATIGUE, WEAKNESS, BLOATING, EDEMA, BURNING EYES, NOSE AND FACE, MUSCLE SPASMS, CHOKING, LARYNGOSPASM, NASAL CONGESTION, SOB, "HUSKY" VOICE, DIZZINESS, DIFFICULTY BREATHING, "UPPER AIRWAY CLOSED," INFLAMED EDEMATOUS VOCAL CORDS, "VIRAL-LIKE" SYMPTOMS, AND WAS DIAGNOSED BY SEVERAL PHYSICIANS WITH ASTHMA AND "HYPERACTIVE AIRWAY 'DISEASE' AS A RESULT OF GLUTARALDEHYDE SENSITI5~TY." THIS SENSITIVITY WAS DOCUMENTED BY A POSITIVE CARBACHOL CHALLENGE TEST. RPTR ALSO NOTES HARASSMENT BY HOSP STAFF REGARDING WORKMAN'S COMPENSATION ISSUES AND INEFFECTIVE REGULATION BY GOVERNMENT AGENCIES. RPTR ALSO SITES SIMILAR MEDICAL PROBLEMS AMONG NUMEROUS CO-WORKERS. (*)
PRE DIALYSIS WT 74.6; POST WT 75.2 KG. DRY WT 72 KG. MACHINE SET TO REMOVE 3 KG. PT SEEN IN ED 7/16 WITHOUT FL OVERLOAD, CHEST PAIN, DIAPHORESIS, ETC. TRANSFERRED PER AIR AMBULANCE FOR ULTRAFILTRATION. EQUIPMENT CHECKED AND FAILED ULTRAFILTRATION TEST. 2ND CHECK IT PASSED, MONITOR SAYS FLUIDS REMOVED; SCALE DOES NOT SUPPORT THIS. BIOMED FOUND THAT THE ULTRAFILTRATION PUMP DID NOT WORK DUE TO FAILURE OF A THERMAL PROTECTION FUSE ON THE PUMP. REPAIRED, RECALIBRATED. EVENT HAPPENED THE NEXT DAY ON ANOTHER PT; INCREASED WT, EDEMA. PT PRESENTED TO EMERGENCY WITH RALES, HYPERTENSION, FLUID OVERLOAD R/O EARLY PNEUMONIA/SEPSIS.
PT FOUND OVER SIDE RAILS OF BED. A CODE WAS CALLED AND CPR WAS STARTED. THE PT EXPIRED. THE PT'S DEATH WAS FOUND TO BE CAUSED BY ACCIDENTAL ASPHYXIATION.
PT CAME TO THE EMERGENCY DEPT ON 7/12/96 AND WAS DIAGNOSED WITH A DISTAL RADIUS FRACTURE. SPLINT WAS APPLIED. ON 7/22/96 THE PT RETURNED TO THE ED WITH A HEALING PARTIAL THICKNESS BURN.
THE PT WAS TAKEN TO THE OR FOR HEMIARTHROPLASTY OF RIGHT HIP, UTILIZING O.D.C. TYPE PROSTHESIS. A SINGLE BATCH OF METHYLMETHACRYLATE WAS MIXED. IT WAS APPLIED AS DIRECTED. AS IT WAS CURING, THERE WAS A SUDDEN DRAMATIC DROP IN HEART RATE AND BLOOD PRESSURE. IT IMPROVED A BIT, BUT THEN CONTINUED TO WORSEN. RESUSCITATION BEGAN. SHE IMPROVED SLIGHTLY, WAS STABILIZED IN POOR CONDITION, AND SENT TO THE RECOVERY ROOM.
WHILE BEING TRANSFERED VIA THE LIFT PT FELL OUT OF THE SLING. SECONDARY EQUIPMENT FAILURE. LEGS CLOSED DURING TRANSFER.
MAJOR SPLASH OF BLOOD, FROM CLOGGED TRANSFUSION SYSTEM. TRIPLE A PROCEDURE  IN PROGRESS.
A 27 GAUGE SPINAL NEEDLE TIP WAS SHEARED OFF DURING PLACEMENT OF SPINAL ANESTHESIA FOR CESAREAN SECTION. REQUIRED A LOCAL EXPLORATION FOR REMOVAL OF NEEDLE FRAGMENT. PT DID NOT SUFFER ANY IMPAIRMENT. CO DOES NOT BELIEVE THIS WAS A USER ERROR ISSUE.
CUSTOMER COMPLAINED THAT LIFTER CONTROLLER BURNED HOLE IN CARPET, EMITTED SMOKE AND 3/4 OF THE CONTROLLER'S CASING MELTED.
USER STATED THAT HE HAD GOTTEN OUT OF CAR AND STARTED UP DRIVEWAY WHEN HE LOST HIS BALANCE (4 SWIVEL WHEELS OH HIS WALKER), FELL ON HIS RIGHT SIDE CAUSING FRACTURE TO RIBS AND HITTING HIS RIGHT TEMPLE BREAKING GLASSES. NO PRODUCT FAILURE OR MALFUNCTION WAS INVOLVED.
71 YR OLD FEMALE WITH PICC LINE IN PLACE FOR HOME CONTINUOUS DOBUTAMINE DRIP AT 5 MCG/KG/MIN. ON OR ABOUT 6/16/96, THE PICC LINE BROKE OFF COMPLETELY BETWEEN THE WING AND HUB. HOMECARE STAFF CLAMPED THE LINE BETWEEN THE BREAK AND PT APPROPRIATELY.
FEEDING TUBE INSERTED, IT EITHER PUNCTURED OR MIGRATED THROUGH ESOPHAGUS CAUSING A PNEUMOTHORAX.
VENOUS ACCESS DEVICE EXPLANTED AND REPLACED DUE TO HOLE IN CATHETER.
PT WAS HAVING PAIN OF RIGHT AXILLA AND BOTH BREASTS WITH FIRMNESS. BILATERAL SUBCUTANEOUS MASTECTOMY BY ANOTHER SURGEON 1990 WITH PROSTHESIS INSERTED IMMEDIATELY POST OP.
PT WAS HERE FOR PORT REMOVAL FROM HER RIGHT SHOULDER. WHEN THE PORT WAS REMOVED THE SURGEON STATED TO PT, "I'M ORDERING A CHEST X-RAY BECAUSE THE TUBING APPEARS TOO SHORT." PT STATED, "NURSE AT ONCOLOGIST'S OFFICE WENT TO FLUSH IT ON TUESDAY AND WHEN SHE WAS INJECTING THE SALINE, FLUID ESCAPED INTO SHOULDER/CHEST AREA. NURSE HEARD/FELT A POP. ONCOLOGIST CHECKED."
DURING PLACEMENT OF CVP CATHETER, GUIDE WIRE BEGAN TO UNRAVEL WHEN MD STARTED TO REMOVE IT. CHEST X-RAY SHOWS NO EVIDENCE OF RETAINED METAL FRAGMENTS FROM GUIDE WIRE.
CONSUMER WAS MISDIAGNOSED BY A DR IN 1988 AS HAVING LUPUS WHEN SHE BEGAN TO EXPERIENCE RASH, BREATHING DIFFICULTY, AND SORES THE SIZE OF A QUARTER THAT WIPED CLEAR FLUID FOR 5-6 MONTHS SHE TOOK PREDNISONE AND HAD BLOOD GLUCOSE PROBLEMS. SHE IS ON INSULIN. IN 9/95 SHE WAS DIAGNOSED AS BEING LATEX SENSITIVE WHEN SHE HAD ANAPHYLACTIC SHOCK DURING A PATCH TEST. FINGERS ARE LIKE TISSUE PAPER. SKIN JUST PEELS OFF AND SHE HAS LOST HER NAILS.
URINARY SPHINCTER IMPLANTED AND FILLED WITH CYSTO CONRAY PER MFR DIRECTIONS. IMPLANT WOULD NOT FUNCTION. IMPLANT REMOVED AND REPLACED WITH SECOND IMPLANT THAT WAS FILLED WITH NORMAL SALINE.
SURGEONS COMPLAINED THE CAMERA WAS BLURRY AND OUT OF FOCUS, AND UNABLE TO SEE ANATOMY. LAPAROSCOPIC CHOLECYSTECTOMY CONVERTED TO OPEN PROCEDURE. BIOMEDICAL ENGINEERING TECH EVALUATION OF CAMERA SYSTEM FOUND THAT THE CAMERA PICTURE HAS TOO MUCH CHROMA (PURPLE). DURING THE PAST YEAR THE CAMERA HAS "HSD" PROBLEMS WITH COLOR CHANGING AND AN INABILITY TO MAINTAIN COLOR DURING SURGERY CASES. THE CAMERA HAS ALSO BEEN FLUCTUATING IN LIGHT INTENSITY, WHICH HAS MADE IT DIFFICULT  TO DISTINGUISH THE COLOR OF TISSUE. THE HOSP OWNS 2 CAMERA SYSTEMS AND BOTH HAVE A HISTORY OF POOR QUALITY PICTURE. BOTH HAVE BEEN RETURNED TO THE MFR TWICE DURING THE PAST YEAR FOR VARIOUS PROBLEMS, THE MFR HAS NOT FOUND ANY PROBLEM WITH THE COLOR FLUCTUATIONS WITH THE CAMERAS. THE MONITORS HAVE ALSO BEEN RETURNED TO THE MFR FOR EVALUATION OF COLOR CHANGES. REPLACED A DIODE IN EACH TO IMPROVE THE PICTURE CONTRAST.
FIRST MACHINE FAILED COMPLETELY, SECOND DEVICE GIVES ERRATIC RESULTS. COMPUTER IS DOWN ALL THE TIME. CO HASN'T PROVIDED PROPER EQUIPMENT AND HAS POOR TECHNICAL ASSISTANCE. FACILITY CAN'T RELY ON THE ANALYZER DUE TO THE CONSTANT PROBLEMS. FACILITY IS SUEING THE CO.
RPTR WAS APPROX 30 YEARS OLD WHEN SHE HAD TWO SILICONE BREAST IMPLANTS PLACED. THESE IMPLANTS WERE THE POLYURETHANE FOAM-COVERED IMPLANTS. PT WAS SENT FOR AN MRI WHICH SHOWED THE LEFT BREAST IMPLANT HAS RUPTURED. AS THEY DID NOT DO A RIGHT BREAST MRI, RPTR IS NOT SURE ABOUT THAT BREAST. RPTR WAS TOLD THAT BECAUSE OF CAPSULING, THE SILICONE IS STILL PROBABLY IN THE BREAST AREA. RPTR WAS TOLD SHE MUST PAY TO HAVE THESE IMPLANTS REMOVED.
SEROLOGIC TESTING USING EPSTEIN-BARR VIRUS IGM KIT HAS YIELDED APPARENT FALSE POSITIVE RESULTS.
THE LIPIDS FOR A NEONATE PT WOULD NOT FLOW DUE TO A DEFECT WITH THE SMALL BORE, THREE LEAD EXTENSION SET. AFTER REPLACING THE PUMP SET, IT WAS DISCOVERED THAT ONE OF THE LINES IN THE TRICONNECTOR WAS BLOCKED. ANOTHER SET WAS TRIED BY THE NURSE AND 2 LINES WERE BLOCKED IN IT.
BILATERAL BREAST IMPLANT EXCHANGE AND BILATERAL BREAST CAPSULECTOMY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
TOTAL CAPSULECTOMIES AND BREAST IMPLANT EXCHANGE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE OF BREAST IMPLANT RIGHT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, NONE OR UNKNOWN.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
BILATERAL BREAST IMPLANT EXCHANGE AND CAPSULECTOMIES.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
UPON NURSING ASSESSMENT OF PT, IT WAS NOTED THAT CATHETER WAS SPLIT. TUBING WAS TAPED IN PLACE. CATHETER REMOVED AND MFR NOTIFIED. NO ADVERSE PT OCCURRENCE/NO SIGNS OF INJURY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING STENT DEPLOYMENT, THERE WAS LOSS OF INTEGRITY OF THE ENCLOSED STENT DELIVERY BALLOON WITH CONCURRENT EXTRAMURAL EXTRAVASATION OF CONTRAST WHICH WAS TEMPORALLY RELATED TO THE LOSS OF BALLOON INTEGRITY. THE 3.0 STENT ALSO DEMONSTRATED LOSS OF BALLOON INTEGRITY WITHOUT EXTRAVASCULAR CONTRAST EXTRAVASATION. ON EX VIVO EXAMINATION, BOTH BALLOONS DEMONSTRATED SMALL HOLES ON THEIR DISTAL ASPECTS. WHILE THE EXTRAVASCULAR DYE EXTRAVASATION APPERED TO "SEAL OFF" WITH BALLOON INFLATION AND DID NOT RESULT IN PARICARDIAL TAMPONADE, INTRAVASCULAR ULTRASOUND DEMONSTRATED THE APPEARANCE OF AN INTRAMURAL HEMATOMA INVOLVING AND COMPROMISING THE LEFT MAIN CORONARY ARTERY AND THE PT WAS REFERRED FOR CORONARY ARTERY BYPASS GRAFTING. IT IS THE FACILITIES ASSUMPTION THAT BECAUSE BOTH THE STENT DELIVERY BALLOON AND THE UNRELATED STENT BALLOON DEVELOPED DISTAL PINHOLE LEAKS THAT A SHARP MALFORMED/MALPOSITIONED STENT STRUT OR A SHARP SPICULE OF CALCIUM WAS RESPONSIBLE FOR THE BALLOON LEAKS AND THAT THE STENT DELIVERY BALLOON LEAK WAS RESPONSIBLE FOR THE EXTRAVASCULAR DYE EXTRAVASATION AND SUBSEQUENT INTRAMURAL HEMATOMA. INTRAVASCULAR ULTRASOUND DATA WOULD NOT SUPPORT THE PROXIMAL VESSEL BEING UNDERSIZED FOR THE 3MM DEVICE AND EXCESSIVE CALCIFICATION WAS NOT PRESENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PT WAS IN THE CO BED IN A SUPINE POSITION. SHE HAD 5 POINT SOFT RESTRAINTS (WRISTS, WAIST AND ANKLES). SHE ALSO HAD HARD BOARD RESTRAINT ON EACH ELBOW. THE BED SIDE RAILS WERE UP. AGAINST THE INSIDE OF THE BED SIDE RAILS WAS A HARD CUSHIONED PLASTIC GUARD (PROVIDED BY THE BED MFR) WHICH RAN THE ENTIRE LENGTH AND HEIGHT OF THE SIDE RAIL (HEAD TO FOOT), AND BETWEEN THE PLASTIC GUARD AND THE AIR MATTRESS WAS AN ADD'L 2 INCH THICK AND WRAPPED IN BLANKETS PADDING (DEVICED BY RPTR), WHICH ALSO RAN THE ENTIRE LENGTH AND HEIGHT OF BOTH SIDE RAILS (HEAD TO FOOT). BOTH THE PADDING AND THE GUARD WERE USED TO DECREASE THE SPACE BETWEEN THE MATTRESS AND THE SIDE RAIL. THE PT WAS ABLE TO KNOCK BOTH THE PADDING AND THE PADDED PLASTIC GUARD TOWARD THE LOWER HALF OF THE BED. SHE THEN MANEUVERED HER BODY IN SUCH A WAY THAT SHE PINNED HER THROAT BETWEEN THE MATTESS AND POINT #3 (SEE DRAWING OF BED). THE DESIGN OF THE CO BED AND SIDE BOARD CONTRIBUTED IN FAILING TO PREVENT THE PT FROM GETTING HER NECK BETWEEN THE AIR MATTRESS AND UNDER THE LOWER EDGE OF THE SIDERAIL.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  DATE LAST SERVICED:  01-APR-96.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  COMPONENT FAILURE, DESIGN - INADEQUATE.  CONCLUSION:  DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE TEMPORARILY REMOVED FROM SERVICE, DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, OTHER.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
NURSE PUT LANCET ON DEVICE AND ATTEMPTED TO DO A BLOOD SUGAR CHECK. THE TOP BUTTON WOULD NOT DEPRESS AND AS SHE EXAMINED IT, THE TOOL POKED HER DIGIT OF HER (L) HAND, BROKE THE SKIN. AFTER DISCOVERING THIS, OBSERVED THAT LANCET HAD BROKEN RESIDENT'S SKIN AND DREW BLOOD.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  DEVICE FAILURE INDIRECTLY CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE DISCARDED.  THE DEVICE WAS DESTROYED/DISPOSED OF.
PT HAD TOTAL KNEES DONE IN 1990. STILL IN PLACE FROM THAT OPERATION ON THE LEFT KNEE ARE THE STEMMED TIBIAL PLATE AND FEMORAL COMPONET. OTHER COMPONENTS WERE REMOVED AFTER PT HAD MULTIPLE DISLOCATION EPISODES AND SUBLAXATION EPISODES. PT UNDERWENT REVISION ARTHROPLASTY WITH CONVERSION OF HIS TIBIAL TRAY TO A LARGER SIZE FOR BETTER SOFT TISSUE BALANCING WHICH STOPPED THE DISLOCATIONS. IN ADDITION, HIS LEFT PATELLAR COMPONENT WAS LOOSE, SO IT WAS REMOVED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  FAIR CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TRAPEZE DEVICE BROKE AND FELL ON PT'S HEAD. NO LOSS OF CONSCIOUSNESS, NO FRACTURE. SCALP LACERATION REQUIRING SUTURES. MILD SWELLING AND ERYTHEMA UNDER LEFT EYE. PT WAS POSTOPERATIVE RIGHT HIP FRACTURE. METAL EQUIPMENT ATTACHED PROPERLY. IT BROKE IN TWO. DIALOGUE WITH MFR TAKING PLACE TO ASCERTAIN CONDITION OF OTHER 18 DEVICES. IDENTIFICATION OF PURCHASE DATE IN PROCESS WITH MFG. PART OF DEVICE RETURNED TO MFR.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  OTHER.  CONCLUSION:  DEVICE FAILURE DIRECTLY CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
LEFT BREAST IMPLANT WAS FOUND TO BE RUPTURED AND IT WAS NOT PREVIOUSLY NOTED ON AMMOGRAPHY, REMOVED. RIGHT BREAST IMPLANT RUPTURED THRU NEW SUBMUSCULAR POCKET INTO SUBGLANDULAR POCKET INTO BREAST TISSUE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
BILATERAL BREAST IMPLANT EXCHANGE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
EXCHANGE OF BILATERAL BREAST IMPLANT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
REVISION OF RIGHT BREAST CONSTRUCTION WITH EXCHANGE OF BREAST IMPLANT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN.  CONCLUSION:  NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  UNKNOWN (CANNOT DETERMINE).  CORRECTIVE ACTIONS:  NONE OR UNKNOWN.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
THE GENERATOR SCHEDULED FOR REPLACEMENT WAS CO'S DEVICE WHICH WAS LABELED AS AN IS-1 LEAD (3.2MM). THE PLAN WAS TO IMPLANT A CO'S GENERATOR WHICH WAS LABELED TO ACCEPT A VS-1 LEAD. HOWEVER, THE CO'S LEAD, WHICH WAS AN IS-1 (3.2MM) CONNECTOR COULD NOT BE INSERTED INTO THE RECEPTOR PORT OF THIS GENERATOR. AN ATTEMPT WAS THEN MADE WITH OTHER CO'S GENERATOR WHICH WAS LABELED FOR AN IS-1 LEAD. HOWEVER, THE EXISTING CO'S LEAD COULD NOT BE INSERTED INTO THE RECEPTOR PORT OF THIS PACEMAKER EITHER. THEREFORE, A DIAG ADAPTER WAS UTILIZED TO REDUCE A 5.2MM LEAD TO A 3.2 MM LEAD, AND THE LEAD WAS THEN CONNECTED TO THE FIRST OTHER CO'S GENERATOR WITHOUT DIFFICULTY. THIS INCIDENT WAS PROMPTLY REPORTED TO A CO'S SVC REP.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DEVICE WAS USED TO POST DILATE ANOTHER CO'S STENT. DISTAL TIP OF BALLOON WAS MISSING. BALLOON ATTACHED TO THE STENT. DEVICE WAS RETURNED TO CO.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  OTHER.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DURING THE FIRST CODE EVENT, THE DEFIBRILLATOR DISCHARGED AT 300 JOULES. IN THE SECOND CODE EVENT, DURING ATTEMPTED DEFIBRILLATION, THE PADDLES WOULD NOT DISCHARGE AT 300 JOULES. THE CHARGE BUTTON HAD BEEN ACTIVATED, THE DEFIBRILLATOR WAS PLUGGED IN AND THE PT WAS BEING MONITORED VIA ANESTHESIA MONITOR, NOT DEFIBRILLATOR MONITOR. IT WAS NOTED THAT THE SYNC MODE LIGHT CAME ON OR HAD BEEN ACTIVATED. DISCHARGE FAILED. THE SYNC MODE WAS DEACTIVATED AND DEFIBRILLATOR THEN DISCHARGED AT 300 JOULES. THE UNIT WAS REMOVED FROM AREA AND A COMPLETE SAFETY AND FUNCTION TEST WAS PERFORMED. THE ROUTINE OR STAFF TESTING ON DEFIBRILLATOR HAD BEEN COMPLETED IN THE AM THE DAY OF THE INCIDENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE.  DATE LAST SERVICED:  01-MAY-96.  SERVICE PROVIDED BY:  INDEPENDENT FACTORY TRAINED/AUTHORIZED SERVICE ORGANIZATION.  SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED.  RESULTS OF EVALUATION:  NONE OR UNKNOWN, INCORRECT TECHNIQUE/PROCEDURE, UNANTICIPATED ADVERSE REACTION - LONG TERM.  CONCLUSION:  DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, NONE OR UNKNOWN.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE TEMPORARILY REMOVED FROM SERVICE.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
BROKEN FEMORAL STEM REQUIRED REVISION TOTAL HIP REPLACEMENT TO CORRECT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  INVALID DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AT 2:00 PM ON 6/25/96, A RESIDENT WAS FOUND BY STAFF MEMBERS LYING ON HER LEFT SIDE ON THE FLOOR. SHE WAS STILL INSIDE OF HER WALKER. THE RESIDENT INDICATED SHE HAD PAIN IN HER LEFT ELBOW. ALTHOUGH THE INCIDENT WAS UNWITNESSED, IT WAS SUSPECTED THAT SHE TIPPED THE WALKER OVER SINCE SHE HAD TIPPED IT OVER ONE TIME BEFORE AND BEEN CAUGHT BY STAFF BEFORE SHE FELL TO THE FLOOR. RESIDENT WAS SENT TO THE ER - DIAGNOSED WITH FRACTURED LEFT ELBOW - TREATED AND RETURNED TO THE FACILITY WHERE SHE IS PRESENTLY IN STABLE CONDITION. THE WALKER HAS BEEN REMOVED FROM RESIDENT USE.DEVICE NOT LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION.  RESULTS OF EVALUATION:  TELEMETRY FAILURE.  CONCLUSION:  DEVICE FAILURE RELATED TO PATIENT CONDITION, THERE WAS NO DEVICE FAILURE.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
DISRUPTED PROSTHETIC IMPLANTS OF LEFT AND RIGHT BREAST WITH SILICONE GRANULOMA FORMATION REQUIRING SURGICAL REMOVAL.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  VISUAL EXAMINATION.  RESULTS OF EVALUATION:  COMPONENT FAILURE.  CONCLUSION:  DEVICE FAILURE DIRECTLY CAUSED EVENT.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  YES.  CORRECTIVE ACTIONS:  DEVICE PERMANENTLY REMOVED FROM SERVICE.  THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
DESCRIBED AS BILATERAL CAPSULAR CONTRACTURES OF BREASTS WITH INTRACAPSULAR RUPTURE OF THE RIGHT IMPLANT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PT HAD RECENTLY BEEN IN AN AUTO ACCIDENT AND HAD COMPLAINED OF KNEE PAIN EVER SINCE. AT THE TIME OF SURGERY DR FOUND THAT THE PEGS OF THE PATELLA HAD SHEARED OFF AND THE PATELLA WAS LOOSE. THE TIBIAL INSERT SHOWED SIGNS OF WEAR AND WAS ALSO REPLACED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THE PT HAD RECENTLY BEEN IN AN AUTO ACCIDENT AND HAD COMPLAINED OF KNEE PAIN EVER SINCE. AT THE TIME OF SURGERY DR FOUND THAT THE PEGS OF THE PATELLA HAD SHEARED OFF AND THE PATELLA WAS LOOSE. THE TIBIAL INSERT SHOWED SIGNS OF WEAR AND WAS ALSO REPLACED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TIBIAL INSERT WAS REMOVED AND REPLACED WITH A 9MM LARGE TIBIAL INSERT.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  SATISFACTORY CONDITION.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ALL POLY TIBIA AND PATELLA WERE REPLACED DUE TO EXCESSIVE WEAR.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
WHEN ATTEMPTING TO ADVANCE THE FILTER FOR DEPLOYMENT, THE TELESCOPING ARM JAMMED. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED TO COMPLETE FILTER DEPLOYMENT TO THE TARGETED AREA WITH NO FURTHER COMPLICATIONS BEING REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
AFTER THE FILTER HAD BEEN PLACED, THE HUB ON THE INTRODUCER BROKE OFF WHEN ATTACHING TO THE POWER INJECTOR'S CONNECTION TUBING WHEN PREPARING FOR THE VENOCAVAGRAM. THE INTRODUCER WAS REMOVED AND REPLACED TO COMPLETE THE VENOCAVAGRAM TO CONFIRM THE FILTER WAS PLACED TO THE TARGETED LOCATION. NO FURTHER COMPLICATIONS REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PLAINTIFFS ALLEGED TO HAVE SUSTAINED LUPUS, POSITIVE ANA AND/OR OTHER SYSTEMIC INJURIES AND DAMAGES, WITHOUT BEING LIMITED THERETO, FROM EXPOSURE TO TOXIC SUBSTANCES.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THESE TWO SUTURELESS MYOCARDIAL LEADS WERE CAPPED, AND REMOVED FROM SVC, BECAUSE OF AN INSULATION BREAK. IMPLANT DATE 2/18/92. REMOVED FROM SVC 6/24/96. TOTAL IMPLANT TIME 52.2 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
REPORTEDLY, HOSP STAFF WERE EXPERIENCING SKIN IRRITATIONS WHILE USING LATEX EXAM GLOVES. SEVERAL ATTEMPTS TO CONTACT THE ACCOUNT WERE MADE. UNABLE TO DETERMINE HOW MANY PEOPLE INVOLVED OR IF MEDICAL TREATMENT WAS NECESSARY. UNABLE TO IDENTIFY MFR DUE TO LOT UNAVAILABLE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
NURSE WAS ATTEMPTING TO FLUSH PT WITH CATHETER WHEN CATHETER WOULD NOT FLUSH. NURSE WAS ABLE TO DEFLATE THE BALLOON. WHEN NURSE REMOVED CATHETER, THE NURSE NOTICED FOREIGN OBJECT BELOW WHERE THE BALLOON WOULD BE. COULD NOT CONFIRM CONCERN WITH THE SAMPLE PROVIDED. NO MEDICAL TREATMENT REQUIRED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TWO PTS WERE IN RECOVERY WHEN NURSE NOTICED THE TUBING COMING OFF THE MASK. NURSE INCREASED THE OXYGEN. BOTH PTS WERE FINE. NO OTHER MEDCIAL TREATMENT REQUIRED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A 25-YR-OLD FEMALE NURSE WITH A HISTORY OF CONTACT LATEX ALLERGY WAS WORKING WITH CO-WORKER WHO WAS WEARING LATEX GLOVES. WHEN CO-WORKER REMOVED GLOVES, THE NURSE HAD AN ALLERGIC REACTION TO THE GLOVES. NURSE WAS TRANSFERRED TO A LARGER FACILITY. NURSE WAS ADMITTED TO THE HOSP OVERNIGHT. NURSE WAS EXPERIENCING RESPIRATORY CONCERNS AND SEIZURES. NURSE WAS ADMITTED TO INTENSIVE CARE. UNKNOWN WHAT TYPE OF MEDICAL TREATMENT WAS REQUIRED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT WAS FOUND WITHOUT OXYGEN FOR INDETERMINED AMOUNT OF TIME DUE TO TUBING COMING OFF THE MASK. NO MEDICAL TREATMENT REQUIRED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
THIS PROBLEM HAS BEEN ADDRESSED WITH CHANGES TO THE SHAPE OF THE BINARY CONNECTOR SPIKE TIP IN ORDER TO ALLEVIATE PROBLEMS WITH DIFFICULT ACTIVATION DUE TO CORING. PRODUCTION OF THE IMPROVED ADD EASE BEGAN IN OCTOBER OF THIS YEAR, AND NATIONWIDE AVAILABILITY IS ANTICIPATED IN FEBRUARY OF 1997.
SPIKABLE PORT ON BAG MISSING. IN ITS PLACE WAS A REGULAR TYPE PORT. PT UNABLE TO SPIKE BAG AS USUAL.
PT COMPLAINING OF PAIN DUE TO DULL NEEDLES. NEEDLES ALSO SOMETIMES GET LOOSE ON SYRINGE. PLUNGER DOES NOT OPERATE SMOOTHLY.
DURING ESOPHAGEAL ANASTOMOSIS, STAPLER FAILED. PROCEDURE COMPLETED WITH SUTURING TECHNIQUE. NO ADVERSE OUTCOME FROM MALFUNCTION OF STAPLER INDENTIFIED AT THIS TIME. SALES REP COULD NOT DUPLICATE PROBLEM. THE SURGEON USED TWO STAPLERS WITH SAME RESULT, POSSIBLE USER ERROR.
A NASAL ASPIRATOR (CLEAR PLASTIC) WAS USED TO SUCTION A BABY'S MOUTH. THE PLASTIC TIP BROKE OFF AND BECAME CAUGHT IN THE CHILD'S TRACHEA. THE CHILD WAS TAKEN TO A HOSP ER, BY AN EMERGENCY MEDICAL TECH (EMT) AMBULANCE, THE CHILD WAS THEN ADMITTED TO THE HOSP AFTER REMOVAL OF THE TIPS AND SUFFERED TRAUMA, AS A RESULT OF THE TIP BEING CAUGHT IN TRACHEA. DR FEELS A WARNING LABEL IS NEEDED TO PREVENT ORAL USE. NASAL ASPIRATOR INCLUDED IN A BOXED KIT THAT ALSO INCLUDES A THERMOMETER, SCISSORS, ORAL MEDICINE SYRINGE, SPOON AND NAIL CLIPPERS FOR INFANT CARE. DR STATED THAT SHE BELIEVED THERE SHOULD BE A WARNING STATEMENT TO CAUTION PEOPLE NOT TO USE THIS PARTICULAR NASAL ASPIRATOR TO SUCTION FROM A BABY'S MOUTH, BECAUSE OF THE POTENTIAL FOR THE PLASTIC TIP TO COME OFF AS IT DID IN THIS CASE.
WHEN SURGEON WENT TO USE PROBE IN THE EYE, HE COULD NOT GET THE CUTTING TO WORK. HE TRIED A SECOND PACK WITH THE SAME RESULTS AND DECIDED TO CLOSE THE EYE AND CANCEL THE CASE.
CENTRAL LINE CAME APART WHICH WEDGED IN THE PULMONARY ARTERY.
PT CAME TO THE OPERATING ROOM FOR A STERNAL CLOSURE AND INTRA-AORTIC BALLOON CATHETER REMOVAL. IT WAS THEN DISCOVERED THAT THE INTRA-AORTIC BALLOON EXTENTION LINE HAD A SMALL AMOUNT OF SEROUS BLOOD INSIDE. PHYSICIAN WAS NOTIFIED AND INTRA-AORTIC BALLOON CATHETER WAS REMOVED. PT SUFFERED A STROKE AFTER THIS PROCEDURE.
LEAK NOTED IN TUBING AT CONNECTION TO PUMP. (PUMP MADE BY SAME MFR.) NO LEAK NOTED DURING PRIMING AND NOTHING UNUSUAL WAS NOTED WHEN TUBING WAS REMOVED FROM THE PACKAGE. TOXOL WAS THE CHEMO DRUG INVOLVED. DUE TO CONTAMINATON BY THE TOXOL THE PRODUCT WAS DISPOSED OF.
PUMP TUBING NON PACKAGED WITH PAPER TAB AROUND TUBING. WHEN PULLING ENDS OF THE TUBING TO STRAIGHTEN IT THE TUBING TIES ITSELF IN NUMEROUS KNOTS. THIS CAUSES SERIOUS DELAYS IN PREPARING IV FLUID IN CRITICAL SITUATIONS.
THE CONDOM TORE COMPLETELY DURING INTERCOURSE -LEAVING ONLY A RING OF CONDOM AROUND THE BASE OF THE PENIS. RPTR HAS USED MANY CONDOMS (100'S ?) IN THE PAST- THIS IS THE FIRST POLYURETHANE ONE TRIED AND IT FAILED DURING NORMAL VAGINAL RECEPTIVE INTERCOURSE. (ALSO THE FIRST CONDOM TO EVER FAIL THAT WE HAVE USED. FORTUNATELY PREGNANCY DID NOT RESULT.
PT COMPLAINT OF DULL NEEDLE. PLUNGER SOMETIMES STICKS ON BARREL WITHOUT COMPLETION OF MEDICATION INJECTION AND REQUIRES A LITTLE EXTRA FORCE TO COMPLETE INJECTION. DIFFUCLTY IN TEACHING PT TO DRAW UP MEDICATION BECAUSE PT CANNOT TELL WHERE BUTTON OF PLUNGERY IS AND IT LOOKS LIKE A BUBBLE IN THE BUTTON WHEN IT IS ACTUALLY PART OF THE SURINGE.
DURING ARTERIOGRAPHY (AT END OF PROCEDURE) PIGTAIL CATHETER SEPARATED (? AT WELD) DURING REMOVAL FROM RIGHT FEMORAL ARTERY PT HAD OBSTRUCTURE DISEASE IN AORTIC BIFURCATION. FORTUNATELY, IT WEDGED SO NO EMBOLUS OF CATHETER OCCURRED.
THIS COMPLAINT IS REGARDING TO COMPLAINANT'S SISTER WHO IS 40 YEARS OLD AND HAS BEEN A DIABETIC SINCE CHILDHOOD. SHE HAD BEEN ON HEMODIALYSIS AND FOR APPROX 6 MONTHS ON PERITONEAL DIALYSIS, WHICH IS DONE EVERY 4 HOURS. ON 3/11 OR 3/12 THE PT HAD TO BE RUSHED TO THE HOSP AFTER SHE BECAME DISORIENTED. BLOOD WORK FOUND HER TO HAVE A WHITE BLOOD COUNT OF 38, HIGH SUGAR COUNT OF 700, RENAL SHUTDOWN, AND RENAL FAILURE, DIAGNOSED AS SEPTICEMIA AND PERITONITIS. THIS DAY, SHE HAD PROBABLY USED 2 TO 4 OF THE SUSPECT DIALYSIS SOLUTION BAGS. COMPLAINANT IS CONCERNED THESE BAGS MAY HAVE BEEN CONTAMINATED. THE PT WAS TREATED AND RELEASED THAT DAY. AFTER GETTING RESULTS OF BLOOD TESTS, SHE HAD DETERIORATED RAPIDLY AND WENT TO THE HOSP VIA AMBULANCE. SHE WAS DIAGNOSED WITH SEPTICEMIA AND ONE DR FELT THERE MAY HAVE BEEN PERITONITIS AS A SECONDARY INFECTION. ON 3/27/96 THE PT WAS TRANSFERRED TO A REHAB HOSP. SHE REMAINS THERE AS OF THIS DATE. ALTHOUGH HER CONDITION HAS IMPROVED SOMEWHAT, SHE IS NOW SUFFERING FROM SHORT TERM MEMORY LOSS. RPTR FEELS THE PERITONEAL FLUID MAY HAVE BEEN CONTAMINATED AND CAUSED THE BLOOD INFECTION IN HER SISTER. RPTR REMEMBERS THE DRS SAYING BLOOD TESTS REVEALED GRAM POSITIVE COCCI, GRAM NEGATIVE RODS AND STAPH AUREUS. THE SAMPLES OF PERITONEAL DIALYSIS SOLUTION FURNISHED TO A LABORATORY FOR TESTING REVEALED: NO GROWTH IN STERILITY TEST MEDIA. NO CONTAINER DEFECT OR PARTICULATE MATERIAL VISUALLY OBSERVED. ADD'L LOT NO: C303669/5B9775. EXP/USE BY DATE: JAN 97 & MAR 97. (*).
SEVERE ALLERGIC REACTION TO LATEX GLOVES, AIRWAYS CLOSED DOWN, MAKING PT UNABLE TO BREATHE, REQUIRING INTUBATION. 11/19/95 RAST TEST PERFORMED CONFIRMING SEVERE LATEX ALLERGY.
PT FOUND ON FLOOR WITH SIDE RAIL OFF BED.
ATRIAL AND VENTRICULAR LEADS FOUND TO HAVE BLOOD IN THE SILICONE ONCE REMOVED FOLLOWING MALFUNCTION.
PT HAD CORONARY ARTERY BYPASS GRAFT SURGERY WITH LEFT INTERNAL MAMMARY ARTERY. PT RETURNED TO OR EMERGENTLY FOR OCCLUSION OF L IMA GRAFT WHICH SURGEON FELT WAS DUE TO THE CLAMP THAT HAD BEEN USED.
DURING PT'S ROUTINE HEMODIALYSIS, NURSE NOTICES INSUFFICIENT VENOUS PRESSURE. BLOOD LINE TUBING FOUND TO BE CRIMPED ON ARTERIAL SIDE. NEW BLOOD LINE WAS SUBSTITUTED. THEREFORE PT'S TREATMENT WAS ADEQUATE. ALL BLOOD LINES FROM THE SAME LOT NUMBER AS THE DEFICIENT BLOOD LINE WERE PULLED. ADD'L 4 LINES FROM SAME LOT WERE INSPECTED AND FOUND TO HAVE CRIMPS. ENTIRE LOT RETURNED TO DISTRIBUTOR. MFR WAS INFORMED 6/6/96.
PROCEDURE: ROTATIONAL ATHERECTOMY. PROBLEM: WITHDRAWAL OF THE BALLOON WAS QUITE DIFFICULT. AT THE TIME OF WITHDRAWAL THE DISTAL HALF OF THE BALLOON WAS NOT ON THE BALLOON SHAFT. ACTION: PT TAKEN BACK TO CATHETERIZATION LAB NEXT MORNING. ANGIOSCOPY AND ULTRASOUND WAS UNSUCCESSFUL IN VISUALIZING ANY BALLOON FRAGMENTS.
TIBIAL ARTICULATING COMPONENT FOUND NOT TO SET PROPERLY. CO REP RETRIEVED ANOTHER COMPONENT FROM A NEARBY HOSP. THIS CAUSED AN APPROX 20 MIN DELAY IN FINISHING SURGERY. NO ADVERSE EFFECTS NOTED.
PT HAD A  CARDIAC CATH AND AN INSERTION OF AN INTRA AORTIC BALLOON CATHETER ON 2/1/96. THE PT WAS THEN TRANSFERED TO SURGERY FOR A CABG. ON 2/4/96 PT DEVELOPED NUMBNESS AND THEN A LOSS OF A FOOT PULSE AS WELL AS A CHANGE IN TEMP OF THE LEFT FOOT. THE PT HAD AN ACUTE ARTERIAL OCCLUSION OF THE LEFT LEG. A LEFT FEMORAL THROMBECTOMY DONE. IABP WAS DISCONTINUED. AN EMERGENT FEM-POP BYPASS WAS PERFORMED. OP NOTE STATES THAT THE COMMON FEMORAL, SFA AND PROFUNDA ARTERIES WERE MARKEDLY HEAVILY DISEASED. THERE WAS A DEFINITE ILIAC LESION THAT WAS FELT WITH THE CATHETER AT ABOUT 12 CM.
EMD PERSONNEL WERE DELIVERING 360 JOULES TO PT WHO WAS LYING IN FLOOR. (PT HAD URINATED THEREFORE, CARPET WAS WET) AND RECEIVED A SHOCK. IT IS ALSO THOUGHT THAT PT'S HAND WAS TOUCHING THE EMT'S KNEE.
VENOUS ACCESS DEVICE (IMPLANTABLE) INSERTED ON 12/13/95. CHEST X-RAY ON 4/29/96 REVEALED THAT THE DISTAL 6 CM OF THE CATHETER HAD SHEARED OFF AND WAS IN THE RIGHT VENTRICLE NEAR THE TRICUSPID VALVE. ON 4/30/96 THE DISTAL CATHETER WAS RETRIEVED UNDER FLUOROSCOPY, VIA TRANSFEMORAL APPROACH, UNDER LOCAL ANESTHESIA, FROM THE MAIN LEFT PULMONARY ARTERY. ON 5/9/96 THE REMAINING PORTION OF THE CATHETER WAS REMOVED FROM THE RIGHT UPPER CHEST. THE TIP OF THE REMAINING CATHETER WAS LOCATED NEAR THE EXPECTED LOCATION OF THE SUBCLAVIAN VEIN/PER RADIOLOGISTS' REPORT. THE PT TOLERATED THE PROCEDURES WELL.
LEFT BREAST RECONSTRUCTION DUE TO IMPLANT, CAPSULAR CONTRACTURE AND PAIN.
WARMING BLANKET WAS BEING USED CORRECTLY ON PT. AFTER APPROX. 15 MIN USE PT BEGAN TO COMPLAIN OF PAIN. SKIN ON LEGS WAS RED. NO VISIBLE BLISTER NOTED. NO PEMANENT INJURY.
HOSE OF WARMING UNIT WAS PLACED UNDER BLANKETS (THE WARMING BLANKET FROM MFR WAS NOT USED). PT BEGAN COMPLAINING OF BURNING ARM AND QUARTER SIZED RED AREAS APPEARED ON LEGS. NO EVIDENCE OF BLISTERS. PAIN AND REDNESS LATER SUBSIDED.
RUPTURED RIGHT BREAST GEL IMPLANT. GEL IMPLANT WAS PLACED AROUND 1978-80 AT MILITARY HOSP.
SURG. BEGAN AT 8:00 (MULTIPLE ORTHOPEDIC PROCEDURES TO HIPS AND LEGS). AT 1040, EXPERIENCED HYPOTENSIVE EPISODE TO 64/40. RESUSCITATED WITH VOLUME AND EPI. GLOVES CHANGED IMMEDIATELY, ROOM "TURNED OVER" WITH NEW NON-LATEX SUPPLIES AND INSTRUMENTS REPLACED (CONCERN FOR LATEX POWDER CONTAMINATION) AND SCHEDULED OPERATIVE PROCEDURES COMPLETED.)
BILATERAL CAPSULAR CONTRACTURES (GRADE 3) AND RIGHT IMPLANT RUPTURE WAS REPORTED.
ANAPHYLACTIC REACTION DURING 5/31 EXTENSIVE LOWER EXTREMITY ORTHOPAEDIC PROCEDURES. PRECIPITOUS BP DROP TO 60/40 BRONCHOSPASM, FLUSHING. OR START TIME 0905-REACTION TIME 0940 PT WAS TREATED AND STABILIZED ANTERIOR PROCEDURES WERE COMPLETED. REMAINDER OF PLANNED PROCEDURES WERE ABORTED AND RESCHEDULED. PR SUBSEQUENTLY UNDERWENT REMAINING SURGERY 6/5/96 IN A LATEX-FREE ENVIRONMENT UNEVENTFULLY. (COMPLETION OF ANTERIOR PROCEDURES WAS DONE WITH LATEX-FREE PRODUCTS.
PT HAD HISTORY OF FAILED LAMINECTOMY SYNDROME AND CHRONIC PAIN. HAD HAD PERCUTANEOUS EPIDURAL SPINAL CORD STIMULATORS PLACED WITHOUT ADEQUATE COVERAGE. ON 5/22/95, A SPINAL CORD STIMULATOR WAS PLACED EPIDURALLY IN THE LOWER THORACIC SPINE. A LEAD WAS IMPLANTED. APPROX ONE MONTH AFTER PLACEMENT IT FAILED AND PT RETURNED TO SURGERY FOR EXPLORATION AND REPAIR. AT SURGERY, AN EVEN BREAK WAS FOUND AT THE END OF THE PLASTIC SHEATH.
PT INHALED SOME SODA LIME RESIDUE THAT HAD ACCUMULATED ON THE TURBINE OF THE PULMONARY FUNCTION MACHINE WHILE DOING A SIMPLE PULMONARY FUNCTION TEST. SHE BEGAN COUGHING ONCE SHE ARRIVED HOME.
THIS PT HAD A SUBCUTANEOUS MASTECTOMY INVOLVING THE RIGHT BREAST AND FOLLOWING SURGERY HAD IMMEDIATE RECONSTRUCTION UTILIZING A TEXTURED IMPLANT ON 6/30/95. FOLLOWING SURGERY SHE HAD SOME DIFFICULTIES WITH ISCHEMIC EDGES OF TISSUE BUT THIS WASN'T TOO MUCH OF A PROBLEM BUT HAD UNRELENTING PRESSURE SYMPTOMS AND PAIN. SHE COULDN'T SLEEP. SHE COULDN'T LAY ON HER SIDE, AND IT WAS VERY FRUSTRATING FOR HER. THERE DID NOT APPEAR THAT THERE WAS ANY INFECTION OR FLUID AROUND THE IMPLANT. PATHOLOGY REPORT INDICATES: AN INTACT BREAST IMPLANT 10 CM IN GREATEST DIMENSION.
INFANT WAS ATTACHED TO NEONATE MONITOR TO MONITOR EKG, RESPIRATIONS, INVASIVE BLOOD PRESSURE AND PULSE OXIMETRY. THE BLOOD PRESSURE IS MONITORED VIA AN UAC LINE. THE UAC LINE WAS DISCOVERED "PULLED OUT", RESULTING IN 40-60CC BLOOD LOSS.
URINARY CATHETER FOUND SEVERED IN AN ELDERLY, DISORIENTED MALE. SUBSEQUENT CYSTOSCOPY PERFORMED TO REMOVE BALLOON AND TIP OF CATHETER. PT ALSO REQUIRED ANESTHESIA FOR PROCEDURE. PT RECOVERED.
THE PT UNDERWENT BILATERAL MASTECTOMY IN 1988 FOR ADENOCARCINOMA. SHE HAS COMPLETED BILATERAL BREAST RECONSTRUCTION. HER INITIAL RECONSTRUCTION WAS COMPLICATED BY PERIPROSTHETIC INFECTION. SHE HAD BILATERAL RECONSTRUCTIVE GEL-FILLED IMPLANTS OF 500 CC ON THE RIGHT AND 550 CC ON THE LEFT. SHE HAS BEEN PLAGUED BY MODEST CAPSULAR CONTRACTURE. PT HAS HAD PROGRESSIVE CAPSULAR CONTRACTION, NOT SEVERE, BUT TO THE POINT THAT IT IS CAUSING DISCOMFORT.
DURING ROTATIONAL ATHERECTOMY 1"-2" PIECE OF GUIDEWIRE BROKE OFF. IT REMAINS IN THE TERMINAL END OF ONE OF THE CORONARY VESSELS. (PT HAS OTHER CARDIAC PROBLEMS THAT HAVE NOT BEEN DETERMINED TO BE RELATED TO THIS.) HOWEVER, IMMEDIATELY POST PROCEDURE HE CODED, WAS RESUSCITATED, RECOVERED AND WAS DISCHARGED SUBSEQUENTLY.
SALINE IMPLANT OF 600CC VOLUME IMPLANTED ON 7/8/92. THIS IMPLANT RECENTLY DEFLATED. AT SURGERY THE PERIPROSTHETIC CAPSULE WAS IDENTIFIED AND OPENED. A PSEUDOMEMBRANE WAS FOUND SURROUNDING THE PROSTHESIS.
INTRA AORTIC BALLOON RUPTURED AFTER 168-200 HRS ("LIFE EXPECTANCY" USUALLY 72 HRS). POST-CABG PT. REQUIRED REINSERTION OF NEW BALLOON.
PT UNDERWENT REMOVAL OF BREAST IMPLANTS BECAUSE OF HIGH UNSATISFACTORY RESULTS. ON THE RIGHT A SMALL AMOUNT OF FREE GEL WAS OUTSIDE THE IMPLANT WITH NO EVIDENCE OF RUPTURE. ON THE LEFT, COMPLETE RUPTURE OF THE IMPLANT WAS ENCOUNTERED.
GOLD BOND TIP OF WIRE DETACHED ITSELF FROM THE SHAFT OF THE WIRE AND BECAME LODGED IN A SMALL BRANCH OF RCA. RETRIEVED WITH A SNARE.
AN INTENSIVIST WAS INSERTING A CENTRAL LINE VIA THE RIGHT SIDE. AFTER INSERTION, WHEN HE WAS ABOUT TO ATTACH THE INFUSION, THE DISTAL PORT BROKE OFF IN HIS HAND. THE CENTRAL LINE REQUIRED AN INSERTION ON THE LEFT SIDE. THIS WAS A SECOND INVASIVE PROCEDURE.
PT WAS BROUGHT TO OR FOR EMERGENCY MITRAL VALVE REPLACEMENT. USING STANDARD TECHNIQUE AND PREP, ANOTHER CO'S INTRODUCER WAS INSERTED BY THE ANESTHESIOLOGIST INTO THE RIGHT INTERNAL JUGULAR VEIN USING THE SELDINGER TECHNIQUE. A CO CONTINUOUS CARDIAC OUTPUT CATHETER WAS THEN INSERTED AFTER HOSP STANDARD PROCEDURE OF FLUSHING CONNECTORS AND INFLATING THE BALLOON BEFORE AND AFTER TRANSVERSING THE SHEATH. THE CATHETER WAS PLACED WITHOUT DIFFICULTY. THE CATHETER WAS WITHDRAWN TO ABOUT 30CM PRIOR TO VALVE REPAIR WITHOUT DIFFICULTY. WHEN TRYING TO MANIPULATE THE CATHETER PRIOR TO COMING OFF BYPASS, THE ANESTHESIOLOIGST NOTICED THAT NO AIR WOULD COME BACK AFTER THE BALLOON WAS INFLATED. THE ANESTHESIOLOGIST TOLD THE SURGEON THAT THE BALLOON MUST HAVE RUPTURED. WHEN THE CATHETER WAS REMOVED THERE WAS NO TRACE OF THE BALLOON ON THE TIP OF THE CATHETER. THE INTRODUCER SHEATH WAS DISSECTED IN ORDER TO SEARCH FOR THE BALLOON. NO BALLOON WAS FOUND. A SECOND CO CATHETER WAS PLACED IN THE LEFT SUBCLAVIAN WITHOUT DIFFICULTY. IT IS NOT KNOWN WHERE THE BALLOON IS, HOWEVER, IT IS LIKELY THAT THE BALLOON REMAINS IN THE PT.
DURING A NEPHROSTOMY TUBE AND STENT PLACEMENT A GUIDE WIRE SEPARATED AND PART OF WIRE WAS LEFT IN THE PT. A TRIP TO THE OR WAS NECESSARY ON 5/29/96 TO RETRIEVE THE PIECE.
A PICC LINE WAS INSERTED ON THIS PT BY A SURGICAL RESIDENT. SEVERAL WEEKS LATER A FOREIGN BODY WAS NOTED IN THE VASCULAR SYSTEM OF THE PT. IT WAS RETRIEVED AND FOUND TO BE THE FLOURESCENT GUIDE THAT HAD APPARENTLY REMAINED IN THE PT AT THE TIME OF INSERTION.
PT FOUND DOWN. NO PULSE. NO RESPIRATION. NO BP. QUICK LOOK CONFIRMED V FIB. ATTEMPT RO CHARGE DEFIBRILLATOR TO 200J. DEFIBRILLATOR WOULD NOT CHARGE. SUBSTITUTED AED DEVICE FOR COUNTERSHOCK. PT SUCCESSFULLY RESUSCITATED AND TRANSFERED TO HOSP.
PT WAS REFERRED TO ELECTRO-PHYSIOLOGY LAB FOR PACEMAKER GENERATOR CHANGE DUE TO EARLY DEPLETION OF PULSE GENERATOR BATTERY.
REMOVAL OF CHEST TUBES ON 1/24 & 1/27 RESULTED IN COMPLETE BREAK OF TUBES REQUIRING SURGICAL REMOVAL OF RETAINED PIECES. NO ADVERSE PT OUTCOME.
PT WAS REFERRED TO ELECRTO-PHYSIOLOGY LAB FOR PACEMAKER REVISION DUE TO ATRIAL LEAD VOLUNTARY RECALL. THE LEAD WAS REMOVED FROM THE CIRCULATION WITHOUT DIFFICULTY ALTHOUGH IT DISINTEGRATED IN THE PROCESS MAKING ASSESSMENT OF THE PROBABILITY OF RETENTION WIRE EMBOLISM VERY DIFFICULT. THE NEW ATRIAL LEAD WAS ADVANCED TO THE LATERAL RIGHT ATRIUM WHERE SATISFACTORY SENSING AND PACING PARAMETERS WERE MEASURED.
GUIDE WIRE SHEARED DURING INSERTION OF CATHETER AND REMAINED IN PLACE IN THE SUPERIOR VENA CAVA.
PT WAS REFERRED FOR TRANSVENOUS ICD REVISION BECAUSE OF CLINICAL AND RADIOGRAPHIC EVIDENCE OF LEAD FRACTURE NEAR THE LEFT CLAVICLE. IT WAS IMMEDIATELY CLEAR DURING THE REVISION THAT THE LEAD WAS TRANSECTED WHERE IT HAS BEEN IMPLANTED THROUGH THE CLAVICULAR PERIOSTEUM INTO THE SUBCLAVIAN VEIN. THE LEAD WAS GENTLY REMOVED AND REPLACED WITH A NEW DSP LEAD.
ATTEMPTED LEFT THORACENTESIS. TIP OF CATHETER SHEARED OFF DURING CATHETER REMOVAL.
RESIDENT WAS IN A RECLINING GERI CHAIR. STAFF FOUND RESIDENT TURNED OVER IN CHAIR HALFWAY IN CHAIR AND PARTIALLY LAYING ON CHAIR ARM IN FLOOR. PHYSICIAN WAS NOTIFIED AND CAME TO SEE RESIDENT AND DID NOT SEE ANYTHING WRONG AT WTHIS TIME. RESIDENT KEPT COMPLAINING AND X-RAY WAS ORDERED ON 3/25/96 AND ON 3/26/96 WAS TAKEN. X-RAY SHOWED FRACTURE OF LEFT LATERAL 7TH RIB AND QUESTIONABLE FRACTURES OF 6TH AND 8TH LEFT. PHYSICIAN DID ORDER PAIN PILL AND TO OBSERVE RESIDENT. POSSIBILITY THAT FRACTURES CAME FROM OVERTURNED CHAIR.
PT WAS REFERRED FOR ABDOMINAL PCD EXPLANT FOLLOWED BY TRANSVENOUS ICD REIMPLANTATION DUE TO FRACTURES IN THE SVC LEAD AND PATCH DEFIBRILLATION LEAD VISUALIZED BY ROUTINE RADIOGRAPHY. THE LEFT DELTOPECTORAL AND ABDOMINAL AREA WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. THE ABDOMINAL POCKET WAS OPENED AND THE DEVICE DISCONNECTED FROM ITS LEADS; THE OLD SVC LEAD WAS COMPLETELY FRACTURED AND THE ABDOMINAL COMPONENT WAS REMOVED FROM THE ABDOMEN. THE PACE/SENSE LEAD WAS UNSCREWED FROM THE RIGHT VENTRICLE AND THE TERMINAL PINS WERE AMPUTATED. THE PECTORAL WOUND WAS THEN OPENED AND THE LEADS DISSECTED FREE USING CAUTERY; THE ANCHORING SLEEVES WERE REMOVED AND THE LEADS WERE BROUGHT BACK UP THE SUBCUTANEOUS TUNNEL FROM THE ABDOMEN. USING LOCKING STYLETS AND EXTRACTION SHEATHS THE RIGHT VENTRICULAR AND SVC LEADS WERE THEN REMOVED FROM THE CIRCULATION; THIS WAS EXTREMELY DIFFICULT BECAUSE THE LOCKING STYLET FRACTURED IN THE RV LEAD AND BOTH LEADS DISINTEGRATED DURING THE REMOVAL PROCESS. THE SUBCUTANEOUS PATCH WAS REMOVED UNEVENTFULLY VIA THE OLD WOUND; THIS ALSO WAS COMPLETELY FRACTURED. A NEW LEAD AND PULSE GENERATOR WERE THEN POSITIONED AND TESTED WITHOUT COMPLICATION.
PT UNDERGOING RLL LOBECTOMY. FIRST VASCULAR STAPLE GUN CAUSED DISSECTION OF PULMONARY ARTERY. SECOND, THIRD ANS FOURTH STAPLE GUNS MAY OR MAY NOT HAVE MALFUNCTIONED. AFTER FIFTH STAPLE GUN ARTERY SEVERED AND TOTAL LOBECTOMY WAS PERFORMED TO SAVE PT'S LIFE. PT CURRENTLY IN ICU.
RPTR'S WIFE WAS OPERATED ON 11/1/95 AT WHICH TIME A STEEL PLATE WAS INSTALLED IN HER ARM, DUE TO A FRACTURE. LATER SHE EXPERIENCED EXTREME PAIN AND ALMOST A TOTAL LOSS OF HER ARM'S MOVEMENT. X-RAYS REVEALED THAT THE PLATE HAD FAILED. RPTR STATED THAT PRIOR TO THE PLATE FAILURE, THERAPY WAS GOING EXTREMELY WELL, BUT BECAUSE OF THE DEFECTIVE DEVICE, ALMOST ALL OF THAT IS LOST. ACCORDING TO THE DR, BROKEN METAL IMPLANTED IN ELBOW CANNOT BE REPLACED/CORRECTED. IT WILL BE A PERMANENT INJURY. IT MAY CAUSE MEDICAL COMPLICATION IF ATTEMPT IS MADE TO CORRECT IT. (*)
RPTR UNDERWENT A PROCEDURE UNDER ANESTHESIA FOR THE REMOVAL OF A BROKEN URETERAL STENT. RPTR WAS ASSURED THAT THIS WAS VERY UNUSUAL, THAT THESE STENTS WERE VERY FLEXIBLE, AND THAT SHE COULD DO WATER AEROBICS AND DANCE. ACCORDING TO THE DR, THIS WAS ONLY THE SECOND CASE OF A BROKEN STENT THAT HE HAD ENCOUNTERED. HOWEVER, ON 1/23 OF THIS YEAR RPTR AGAIN HAD TO GO THROUGH THE SAME PROCEDURE BECAUSE OF ANOTHER BROKEN STENT. SINCE BOTH STENTS BROKE IN EXACTLY THE SAME PLACE, RPTR BELIEVES THEY ARE DEFECTIVE.
CARDIO-RESPIRATORY ARREST, SUCCESSFULLY RESUSCITATED. NURSE STATES VENT WAS NOT FUNCTIONING ON ARRIVAL IN ROOM. PT MANUALLY BAGGED WITH AMBU BAG CONNECTED TO TRACHEOSTOMY TUBE. EVALUATION: UNABLE TO DUPLICATE PROBLEM ON AC AND INTERNAL BATTERY TEST. EXTERNAL BATTERY DRY.
A 64 YR OLD FEMALE PRESENTED TO EMERGENCY ROOM FROM A NURSING HOME WITH SHORTNESS OF BREATH. PT TRANSPORTED BY EMS AND THEY WERE UNABLE TO GET A BLOOD PRESSURE READING ON THIS PT. PT WAS PLACED ON A VENTILATOR AND IT WAS SET AT 12 BREATHS PER MINUTE. PROGNOSIS OF PT WAS VERY POOR. AT 6:00 P.M., THE PT WAS FIRST PLACED ON THE VENTILATOR. AT 7:12 P.M. BALLARD ON VENT WAS CHANGED. AT ABOUT 8:30, DURING AN EVALUATION, PT'S HEART RATE DECREASED TO 40. AT THAT TIME, IT WAS NOTED THAT THE SETTING ON THE VENTILATOR WAS AT 42 INSTEAD OF 12. PT WAS PRONOUNCED AT 8:57 P.M.
IAB PLACED IN PT AT BEDISDE ABOUT 3AM 7/12/96 DUE TO HYPOTENSIVE EPISODE. AROUND 10-10:30 AM IABP BEGAN TO HAVE HELIUM LOSS ALARM BUT NO BLOOD WAS NOTED IN BALLOON CATHETER. ALARM PERSISTED AND BLOOD NOTED IN IAB CATHETER AT 11AM AND MDR WAS NOTIFIED. PERFUSIONIST IN TO CHECK AND CONFIRMED LEAK IN IAB CATHETER. IABP D/C ABOUT 7PM 7/12 BY MD. TIP OF BALLOON WAS MISSING.
PORT INSERTED 4/22/96. AFTER 2ND DOSE OF ADRIAMYCIN/CYTOXIN, PT DEVELOPED RED AREA AROUND PORT. PORT REMOVED 5/22/96. AREA LEFT OPEN FOR PACKING. STAFF OBTAINED GOOD BLOOD RETURN PRIOR TO AND THROUGHOUT CHEMO ADMINISTRATION.
FAKE FINGERNAIL INSIDE PLASTIC WRAP OF BAG CONTAINING 10 PACKS OF STERILE 30ML SYRINGES.
ON 5/31/96 A SURGEON WAS IN THE INITIAL PHASE OF PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY. SOME DIFFICULTY WAS ENCOUNTERED WITH INSERTING THE TROCAR BUT THE FUNCTION OF THE INSTRUMENT AT THE TIME WAS NOT IN QUESTION. UNFORTUNATELY WHEN THE ABDOMEN WAS ENTERED IT WAS FOUND THAT THERE WAS A LACERATION OF THE VENA CAVA. THIS WAS REPAIRED QUICKLY. POST OPERATIVELY THE PT DEVELOPED A DVT OF THE LOWER EXTREMITY AND A HEMATOMA THAT RESULTED IN A PROLONGED STAY. EXTENSIVE PEER REVIEW WAS DONE WITHIN 1 WEEK OF THE INCIDENT AND IT WAS FELT THAT THE TECHNIQUE USED BY THE MD WAS WELL WITHIN THE STANDARD PARAMETERS. AT THAT TIME A QUESTION WAS RAISED REGARDING THE TROCAR USED AND IF THERE COULD HAVE BEEN AN EQUIPMENT MALFUNCTION. THE SURGEON AND THE PEER REVIEWERS DID NOT THINK SO, HOWEVER, AT A GENERAL SURGERY MEETING 7/18/96 (SECOND REVIEW) THE QUESTION AGAIN SURFACED AND THE POSSIBILITY OF MALFUNCTION OF THE TROCAR WAS AGAIN RAISED. RPTR IS QUITE CONFIDENT THAT THIS WAS NOT USER ERROR AS THIS MD HAS PERFORMED AT LEAST 400 LAP CHOLECYSTECTOMIES IN THE PAST AND PEER REVIEW ENDORSED HIS TECHNIQUE. FACILITY HAS RECENTLY QUESTIONED OTHER STAPLING PRODUCTS AND HAS IN FACT REQUESTED INFO THROUGH THE "FREEDOM OF INFO ACT."
THE PT CAME IN TO PICK UP HER MEDS FOR BIAXIN, VANCERIL INHALER AND MAXAIR INHALER AND TO RECEIVE COUNSELLING AS REQUIRED BY LAW. RPTR ASKED IF SHE USED A SPACER WITH HER INHALERS AND THEN ASKED IF SHE WASHED IT REGULARLY. SHE SAID SHE HAD NEVER WASHED IT AND RPTR ASKED TO SEE IT. THE INSPECTION SHOWED MOLD OR BACTERIAL GROWTH INSIDE. AT THAT POINT RPTR ASKED HER TO GO BACK TO THE DR AND GET AN ORDER FOR ANOTHER CHAMBER SINCE HER'S WAS BEYOND CLEANING. RPTR ALSO TOLD HER THAT THE CONTAMINATED DEVICE WAS PROBABLY THE CAUSE FOR THE PULMONARY INFECTION TREATED WITH BIAXIN.
DURING A VENOGRAM PROCEDURE WITH THE X-RAY TABLE IN A SEMI-UPRIGHT POSITION (ESTIMATED 45 DEGREES) THE FLOATING TABLE TOP SEEMED TO BREAK LOOSE FROM THE REST OF THE TABLE ASSEMBLY AND SLIDE TOWARDS THE FLOOR. X-RAY PERSONNEL WERE ABLE TO MANUALLY CONTROL THE MOVEMENT OF THE TABLE TOP. THE TABLE WAS PLACED IN A HORIZONTAL POSITION AND THE PT SAFELY REMOVED WITHOUT INJURY. UPON INSPECTION BY EQUIPMENT SVC PERSONNEL IT WAS DETERMINED THAT A GEAR THAT HOLDS THE TABLE TOP CHAIN SLID OFF THE SHAFT OF THE MOTOR. THUS ALLOWING THE TABLE TOP TO FLOAT FREELY. THIS EQUIPMENT IS NORMALLY MAINTAINED BY A THIRD PARTY RADIOLOGY SVC VENDOR. THE THIRD PARTY VENDOR REPLACED THE GEAR BOX IN QUESTION AROUND 8/3/95.
A 79 YR OLD FEMALE, KNOWN DIABETIC AND KNOWN CASE OF COPD, IN RESPIRATORY FAILURE AND KNOWN MECHANICAL VENTILATORY SYSTEMS. DOING INSERTION OF A CENTRAL VEIN LINE THROUGH THE RIGHT SUBCLAVIAN APPROACH, A GUIDEWIRE COULD NOT BE RETRIEVED AND X-RAY, EVENTUALLY DISCLOSED GUIDEWIRE TO BE LOOPED WITHIN THE SUPRACLAVICULAR POSITION. SURGICAL RETRIEVE ADVICE. FLUOROSCOPIC EXAM DISCLOSED NO FURTHER PIECES OF WIRE REMAINING IN THE BODY.
POST OPERATIVE OPEN HEART PT WITH AN INTRA-AORTIC BALLOON PUMP IN USE. DURING THE WEANING PROCESS, THE BALLOON PUMP ALARM BEGAN SOUNDING, NOTED FIRST HIGH PRESSURE AND THEN A LEAK. APPROX. 20-30 MINUTES LATER, BLOOD WAS NOTED IN THE CATHETER. THE SURGEON WAS CONTACTED AND THE CATHETER BALLOON WAS NOTED TO BE RUPTURED.
PT HAD EMBOLECTOMY FOR RIGHT ARM AV SHUNT CLOT. DURING PROCEDURE, SMALL PIECE OF CATHETER/BALLOON BROKE OFF IN PT. X-RAY TAKEN IN OR. COULD NOT VISUALIZE BALLOON. PT HAD SUCCESSFUL DIALYSIS AFTER SURGERY-SHUNT WORKED-SENT BACK TO CONVALESCENT HOSP.
PT BEING SCANNED FOR MR OF THE THORACIC AND LUMBAR SPINE. PT SEDATED AND IN PAIN. PT COMPLAINING OF BEING HOT. PT WAS SWEATING PERFUSELY. TECHNOLOGIST NOTICED ARTIFACTS ON MRI IMAGES. PT PROCEDURE WAS COMPLETED. MFR RESPONDED TO SVC CALL TO CORRECT ARTIFACT PROBLEM. MFR INDICATED TO MR TECHNOLOGIST THAT THE SPINE COIL WAS OVERHEATING. THE NEXT MORNING THE PT WAS CHECKED BY THE RN FOR ANY POSSIBLE SKIN REDDENING OR BURNS AT THE AREA OF THE COIL PLACEMENT. NO PT INJURY WAS NOTED. MFR ORDERED A NEW SPINE COIL AND REMOVED MR COIL IN QUESTION.
FOLLOWING THE INSERTION OF A LEFT CATH PICC LINE, DURING THE WITHDRAWAL OF THE GUIDEWIRE, A SMALL PIECE OF SHREDDED MATERIAL WAS NOTED COMING OUT OF THE CANNULA. THE LINE WAS FLUSHED WITHOUT RESISTANCE. AFTER EXAMINING THE GUIDEWIRE AND THE SHREDDED MATERIAL, THE PICC LINE WAS REMOVED.
BALLOON TO DEPLOY STENT INFLATED TOO HIGH; BALLOON RUPTURED AND STENT PERFORATED CORONARY ARTERY. PT URGENTLY TAKEN TO OPEN HEART SURGERY.
DURING SURGERY FOR LAPAROSCOPIC CHOLECYSTECTOMY, GRASPING FORCEPS INSTRUMENT LOST ONE OF ITS SERRATED ENDS. C-ARM USED TO LOCATE THE SERRATED END AND THE ABDOMINAL INCISION EXTENDED SLIGHTLTY TO ENABLE ITS REMOVAL. UPON REMOVAL, IT APPEARED INTACT AS FAR AS ITS ADJOINMENT TO THE ORIGINAL CLAMP.
RPTR C/O RUPTURED RIGHT IMPLANT WITH LEAKAGE OF SILICONE OUTSIDE OF THE CAPSULE PERIPHERAL NEUROPATHY R ARM/HAND, ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, ELEVATED CHOLESTEROL OR TRYGLYCERIDES, THYROID PROBLEMS, CHRONIC SWELLING OF EXTREMITIES, CHRONIC PAIN, HEAT OR COLD, SENSITIVE EXTREMITIES, FREQUENT LOW GRADE FEVER, CHRONIC DIARRHEA &/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, SEVERE PMS SYMPTOMS, SEVERE MENSTRUAL PROBLEMS AND IRREGULARITIES, SUBSTANTIAL HAIR LOSS NOT CONNECTED WITH MEDICATION, FREQUENT MIGRAINES/SEVERE HEADACHES, HYPERSENSITIVITY TO MOLDS, DUST OR POLLEN, UNUSUAL CHRONIC INFECTIONS SUCH AS MYCOPLASMA PNEUMONIA, SINUSITIS, OTITIS, INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, PERSISTENT JOINT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY UNDER ARMS, FROZEN SHOULDER, MUSCLE PAIN AND BURNING, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, NUMEROUS MOLES, FRECKLES, ETC, NON-RESTORATIVE SLEEP, CHEST PAIN, CHRONIC FATIGUE SYNDROME DIAGNOSED 1 YR AFTER IMPLANTATION, LONG-TERM EXTREME FATIGUE, CLUMSINESS/DROPS THINGS AND MISJUDGING DISTANCE/RUNNING INTO OBJECTS, AND SICCA.
TWO DAYS POST APPENDECTOMY, INTRA-ABDOMINAL DRAIN WAS BEING REMOVED. EXTERNAL SKIN SUTURE WAS REMOVED, DRAIN WAS DECOMPRESSED, AND TRACTION PLACED ON DRAIN. INITIALLY SLID OUT OF SUTURE LINE EASILY, BUT WHEN FLAT AREA OF TUBING WAS APPROX. 2" OUT, THE DRAIN SNAPPED, LEAVING DISTAL PORTION IN NURSE'S HAND AND RETRACTING REMAINDER OF DRAIN INTO THE ABDOMINAL. PT RETURNED TO SURGERY FOR SURGICAL REMOVAL OF RETAINED PORTION OF DRAIN. NO EVIDENCE OF INTRA-ABDOMINAL SUTURING OF DRAIN OR ANY VISIBLE MECHANICAL REASON FOR DIFFICULTY IN PULLING DRAIN.
DEFIBRILLATOR PADS SPARKED WHEN USED. PT EXPIRED BUT NOT AS A RESULT OF THIS MALFUNCTION. PT WAS ALREADY IN ASYSTOLE WHEN DEFIBRILLATOR USED AND BACK-UP EQUIPMENT WAS AVAILABLE. CO REP WAS NOTIFIED OF INCIDENT. DEFIBRILLATOR MFG BY SAME CO WAS TESTED AND NO PROBLEM IDENTIFIED WITH IT. THE ONLY PROBLEM NOTED WAS WITH THE PADS WHICH HAD DISCOLORATION NEAR THE END OF ONE ELECTRODE (PROXIMAL).
WHILE PLACING A FILTER, IT DEPLOYED INTO THE (R) ATRIUM PREMATURELY. CATHETER WAS LOCKED AND DEVICE OPENED DESPITE LOCK.
PT WAS TO RECEIVE TPN OVERNIGHT. EDUCATION/OPERATOR ERROR WAS DISCOVERED AFTER 2 FULL CYCLES WERE MISSED DUE TO OMISSION OF THE DUAL RESET OF THE RES VOL SCREEN AND THE INFUSION SCREEN. POTENTIAL FOR DEHYDRATION SECONDARY TO MISSED DOSE. "REMINDER" LABEL WAS ON PUMP REGARDING THE DUAL RESET.
PEG TUBE WAS INSERTED ON 12/15/95; PT SYMPTOMATIC AND FLUOROSCOPIC EXAM SHOWED EXTRAVASATION OF CONTENTS. BALLOON WAS DISCOVERED TO BE DEFLATED UPON REMOVAL ON 12/17/95.
PT HAD AUTOMATIC PB CUFF ON UPPER RIGHT ARM. CUFF HAD PREVIOUSLY BEEN ON L ARM BUT HAD IV STARTED SO IT MOVED TO R ARM. PT HAD VENIPUNCTURE IN R ANTECUBITAL FOSSA. BP CUFF AUTOMATICALLY INFLATED AND WAS VERY TIGHT. PT CAME BACK TO HOSP ONE WEEK LATER TO SHOW LARGE SWOLLEN AREA IN ELBOW NEAR VENIPUNCTURE SITE. NOT ABSORBED QUICKLY. MD IS FOLLOWING PT. DO NOT BELIEVE THERE IS PERMANENT DAMAGE, BUT SUBMITTING THIS AS A PRECAUTIONARY REPORT.
ANASTOMOTIC LEAK POST-OP, LEFT COLECTOMY WITH LOW ANTERIOR RESECTION 5/7/95. PRE-OP IRRADIATION, ANASTOMOSIS CHECKED AT TIME OF SURGERY WITH SALINE AND AIR AND REVEALED NO EXTRAVASATION AT THAT TIME.
8/7/95 LEFT COLECTOMY WITH LOW ANTERIOR RESECTION. 8/18/95 RETURN TO SURGERY TO DRAIN ABSCESS DUE TO AN ANASTOMOTIC LEAK. ANASTOMOSIS CHECKED WITH SALINE AND AIR AT TIME OF SURGERY 8/7/95, NO EXTRAVASATION AT THAT TIME.
THIS 70 YR OLD FEMALE WAS UNDERGOING PHYSICAL THERAPY WITH A GALVANIC ELECTROSTIMULATOR TO RIGHT LOWER LEG FOR FOOT DROP. THE MACHINE WAS SET AT 20 MILLIAMPS(GOES FROM 0 TO 80). ELECTRODE PLACED FOR 15 MIN. NO COMPLAINTS FROM PT. 4 DAYS AFTER THIS TREATMENT PT PRESENTED TO HOSP E.R. THE E.R. PHYSICIAN DOCUMENTED 2 1/2 CM BURNS ADJACEMENT TO EACH OTHER AND ANOTHER REDDENED AREA. HE DESCRIBED THE TWO AREAS AS PROBABLE NEARLY FULL THICKNESS BURNS. THE AREA DID NOT APPEAR INFECTED. A DRESSING OF SILVADENE WAS APPLIED. SHE WAS GIVEN A TETANUS INJECTION BOOSTER. SHE WAS INSTRUCTED TO CHANGE DRESSINGS AND WASH DAILY AT HOME AND TO RETURN TO THE E.R. PT CHOSE TO FOLLOW WITH HER FAMILY DR. THE MACHINE WAS CHECKED BY THE BIOMEDICAL DEPT. 5 DAYS AFTER THE INCIDENT AND EVALUATED AS HAVING NO MALFUNCTION FOUND. THE LAST DATE OF PREVENTIVE MAINTENANCE WAS 4/28/95. THERE WAS ONLY ONE OCCASION DURING THE LIFE OF THIS MACHINE WHEN A PROBLEM OCCURRED; THERE WAS A SHORT ON 1/28/94. THE CABLES WERE REPAIRED.
THIS 29 YR OLD FEMALE HAD A LEFT MYRINGOTOMY TUBE INSERTED. WHEN SHE PRESENTED FOR THE SURGERY SHE HAD SOFT CONTACT LENSES IN HER EYES; A NURSE GAVE THE PT EYESTREAM TO SOAK THE LENSES DURING SURGERY; AFTER SURGERY TEH PT PUT THE LENSES BACK IN HER EYES AND HER EYES BECAME READ AND TEARY; THE NURSE THOUGHT TEH PT AHD AN ALLERGIC REACTION; WHEN THE PT WENT HOME SHE CINTINUED TO HAVE PROBLEMS AND WENT TO AN OPTOMETRIST WHO CALLED THIS WRITER; HE SUGGESTED THAT SOLUTION SHOULD NOT HAVE BEEN USED TO SOAK THE LENSES. PT SUSTAINED A CHEMICAL BURN REQUIRING FOLLOW UP CARE. THE BOTTLE DOES NOT STATE THAT THIS SOLUTION IS NOT TO BE USED AS A SOAK FOR SOFT LENSES. THE BOX HOWEVER DOES STATE THE FOLLOWING "NOT TO BE USED AS A SALINE SOLUTION FOR RINSING AND SOAKING SOFT CONTACT LENSES". THE OPTOMETRIST DOES NOT BELIEVE THE PT WILL HAVE PERMANENT DAMAGE.
A 63 YR OLD MALE PT PRESENTED WITH A LEAKY CATHETER, WHICH HAD BEEN PLACED ABOUT TWO YEARS PRIOR FOR PERITONEAL DIALYSIS. THE CATHETER APPEARED CRACKED AND DEGRADED IN AN AREA EXTERNAL TO THE PT. THE DISTAL 5 CM OF THE CATHETER WERE CUT OFF AND AN EXTENSION CATHETER PIECE WAS ATTACHED. THE PT SUSTAINED NO COMPLICATIONS.
ANASTOMOTIC LEAK POST-OP, ESOPHAGOGASTRECTOMY 5/22/96. BARIUM SWALLOW REVEALED LEAK 4 DAYS POST-OP - SMALL BUT RESULTED IN PROLONGED POST-OP CARE WITH MEDIASTINITIS.
A 44 YR OLD MALE WITH ACUTE INFERIOR MYOCARDIAL INFARCTION. ARTERIAL ACCESS LINE INSERTED IN LEFT RADIAL ARTERY. DURING PROCEDURE. PHYSICIAN BECAME AWARE THAT THE HUB WAS ABROKEN OFF OF THE ARTERIAL CATHETER. PT'S UNSTABLE CONDITION PREVENTS SURGICAL REMOVAL OF THE CATHETER AT THIS TIME.
4/11/96 LEFT COLECTOMY WITH LOW ANTERIOR RESECTION. PT DEVELOPED POST-OP LEAK WITH PERITONITIS WITH READMISSION ON 4/21/96. PROGRESSED TO MULTIPLE SYMSTEMS ORGAN FAILURE. ANASTOMOSIS TESTED AT TIME OF SURGERY 4/11/96, SALINE AND AIR WITH NO EXTRAVASATION.
DENTAL OFFICE REPORTS INCIDENCES OF COMPUTER SOFTWARE ERRONEOUSLY DUPLICATING PT INFO ON OTHER PT'S RECORDS. CO WAS CONTACTED BY RPTR AND ACCEPTS NO RESPONSIBILITY FOR EVENT.
WHILE DRILLING THROUGH THE SKULL DURING CRANIOTOMY WITH #14 PERFORATOR, THE DRILL WENT THROUGH THE DURA.
RPTR GETS DELAYED ALLERGIC REACTION AFTER USING GLOVE. MORNING AFTER USING GLOVE, HIS HANDS BREAK OUT IN HUNDREDS OF BLISTERS. NEXT, BLISTERS START TO WEEP, SKIN CRACKS AND PEELS OFF, MAKING IT EXTREMELY PAINFUL. RPTR HAS DEVELOPED CONTACT DERMATITIS. NOW, HE REACTS TO RUBBER HANDLES.
TRAUMA SURGEON NOTED A SIGNIFICANT AMOUNT OF AIR INFUSING INTO THE IV LINE. PT BEGAN EXPERIENCING RESPIRATORY DIFFICULTY RESOLVED WITHIN 30 MINUTES. IV WAS IMMEDIATELY CLAMPED AND SOLUTION BAG CHANGED.
DIFFERENT READINGS RESULTING FROM EITHER NOT ENOUGH BLOOD SAMPLE FOR MACHINE TO FUNCTION PROPERLY OR MACHINE IS NOT RECORDING PROPERLY.
VENTILATOR MALFUNCTIONED AND STOPPED VENTILATING. TURNED OFF THEN BACK ON WHILE RN'S AMBUD PT. VENT WOULD NOT RESET. REPLACED WITH ANOTHER VENTILATOR. NO HARM TO PT. SAO2 100% THROUGHOUT. THIS INCIDENT OCCURRED DURING A LIGHTNING STORM.
7/13/96 AT 1500 THE PT WAS RECEIVING TPN VIA AN IMPLANTABLE PORT WHICH WAS ACCESSED WITH AN NON-CORING WINGED INFUSION SET. THE TUBING FROM THE SET PULLED AWAY FROM THE NEEDLE WHICH WAS IN THE PORT, A VENOUS ACCESS SYSTEM. THE NEEDLE STAYED IN THE PORT RESULTING IN THE PT BLEEDING APPROX 5-10 CC BLOOD FROM THE PORT BEFORE THE PT'S MOTHER COULD PULL THE NEEDLE OUT OF THE PORT.
VENTILATOR FAILED TO CYCLE AND NO ALARM WAS HEARD. PT'S SPO2 DROPPED FROM 92% TO 87%.
POST-SURGERY PT FELT GREAT. 5 MONTHS POST-OP PT HAD INCREASED PAIN IN LUMBAR REGION WITH INCREASED DIFFICULTY WITH AMBULATION, LIMPING, AND UNABLE TO SIT LONGER THAN 15-20 MINS AT ONE TIME. STANDING FOR A PERIOD OF 10 MINS OR MORE INCREASES PAIN IN BACK. PT ALSO REPORTS INCREASED FATIGUE, PAINFUL SWOLLEN JOINTS IN UPPER EXTREMITIES AND CONTINUED BACK PAIN WHICH REQUIRES PAIN MEDICATION DAILY.
UPON TRITURATION THERE WERE NUMEROUS CAPSULES THAT CONTAINED EXCESS POWDER AND/OR EXCESS LIQUID AND RESULTED IN MATERIAL NOT SUITABLE FOR RESTORATIVE USE.
PT HAD A PACEMAKER PLACED IN 8/89. APPROX. TWO YEARS AGO THE PT'S LOCAL MD FOUND THE ATRIAL LEAD TO BE MALFUNCTIONING. THE LEAD WAS PROGRAMMED TO SHUT DOWN, AND THE PACEMAKER CONVERTED TO VBI MODE. SHE WAS BEING MONITORED BY HER LOCAL MD FOR ATRIAL LEAD PROBLEMS. ON 5/1/96, THE PT WAS FOUND TO HAVE A LOOSE WIRE IN THE ATRIUM AND UNDERWENT RETRIEVAL OF THE WIRE ON 5/3/96. TEH DECISION WAS MADE NOT TO REMOVE THE LEAD AT THIS TIME AS THE PT WAS IN ATRIAL FIBRILLATION AND VVI PACING.
TIP OF "CROCHET" HOOK PROBE BROKE OFF INSIDE PT'S LEFT GREAT TOE.
A FAMILY MEMBER OF THE PT REPORTED THAT THE PUMP IS NOT WORKING PROPERLY - PUMP SCREEN IS SHOWING SYSTEM ERROR.
PT EXPERIENCED HYPERTENSIVE/TACHYCARDIC EPISODE. THE VENTILATOR WAS DELIVERING PRESET BREATHS VOLUME. RT DID NOT THINK IMV BREATHS WERE CONSISTENT WITH PTS EFFORTS. BIOMED ENGINEER TESTED DEVICE AND FOUND TRIGGER SENSITIVITY TO BE INACCURATE AT A MEASURE OF >10CC H2O DUE TO A DEFECTIVE PRINTED CIRCUIT BOARD. THIS WAS REPLACED BY BIOMED. THE EVENT COULD HAVE BEEN SERIOUS IF THE RESPIRATORY THERAPIST WAS NOT PRESENT AS THE DEVICE FAILED.
DURING A CRANIAL ARTERIOGRAPHY THAT WAS INITIATED VIA A RIGHT COMMON FEMORAL APPROACH, THE CATHETER WIRE PERFORATED WITHIN THE DISTAL AORTA. AS THE CATHETER WAS WITHDRAWN THROUGH THE GROIN, A SMALL PIECE OF THE CATHETER TIP SHEARED OFF AND BECAME LODGED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE LEFT COMMON FEMORAL ARTERY WAS CANNULATED WITH A 7-F SHEATH THROUGH WHICH A GUIDE WIRE AND GUIDING CATHETER WERE ADVANCED TO THE FRAGMENT. A 10-F GOOSE NECK SNARE WAS IMPLEMENTED THROUGH THE GUIDING CATHETER TO RETRIEVE THE FRAGMENT. DURING THE PROCEDURE, HR 46 AND BP 109/44. SUCCESSFULLY TREATED WITH IV FLUID BOLUS AND ATROPINE. PT WILL BE DISCHARGED TO HOME 3/13/96 STATUS POST CAROTID ENDARTERECTOMY.
WHEN INSERTING BATTERY AND TRYING TO PUT THE PUMP INTO LL0, THE PUMP WOULD NOT RESPOND, RETURNING TO MFR FOR REPAIRS.
THE RECANALIZATION GUIDEWIRE COULD NOT BE MADE A CROSS A CHRONICALLY OCCLUDED LAD LESION USING BALLOON AND WIRE TECHNIQUE. AS THE WIRE WAS REMOVED, THE WIRE FRACTURED AND SEPARATED IN THE AORTA LEAVING APPROX. 10CM IN THE ASCENDING AORTA WHILE REMAINING LODGED IN THE LAD. ATTEMPTS TO RETRIEVE THE WIRE WITH A CATHETER AND SNARE WERE NOT SUCCESSFUL. CORONARY ARTERY BYPASS SURGERY WAS PERFORMED TO EXTRACT THE WIRE FRAGMENT AND TO BYPASS HIS LAD AND CIRCUMFERENCE CORONARY VESSLES. THE WIRE WAS EXTRACTED UNEVENTFULLY.
ON TWO OCCASIONS, A DOUBLE LUMEN SUBCLAVIAN CENTRAL LINE, IN PLACE FOR LESS THAN 24 HRS, BROKE OFF AT THE PORT CAP JUNCTURE WITH A "POP." LINE CLAMPED WITH MINIMAL BLOOD LOSS AND LINE REPLACED IN OR EACH TIME.
THREE PTS CONTINUE TO C/O NEEDLES BEING DULL. ALSO, THE PLUNGER DOESN'T ALWAYS WORK AND CATCHES IN THE BARREL. THE PLUNGER ALSO REQUIRES EXTRA PRESSURE TO COMPLETE INJECTION. RPTR HAS HAD TO DISCARD 4 SYRINGES DUE TO SEVERAL PROBLEMS. 1. NEEDLE FALLS OFF, 2. THE NEEDLE BECOMES LOOSE AND PULLS INTO BARREL.
PTS C/O NEEDLE BEING DULL; PLUNGER DOES NOT OPERATE SMOOTHLY. IT CATCHES IN BARREL AND REQUIRES ADD'L PRESSURE TO COMPLETE INJECTION.
FEMALE, 42-YRS-OLD, HAD OUTPATIENT CHEST TUBE PLACED 7/17. IT STOPPED WORKING AND WAS REPLACED 7/19 WITH SAME TYPE DEVICE. PT PRESENTED 7/20 WITH TENSION PNEUMOTHORAX.
OBSERVED ARTERIAL LINE TRANSDUCERS CRACKING AT LAST JUNCTION ON TRIPLE AND DOUBLE TRANSDUCER MANIFOLDS.
OPENED BOX 1CC 22 GAUGE 1 INCH NEEDLE/SYRINGE AND FOUND SEAL HAD NOT HELD AND SYRINGE PACKAGES WERE ALREADY OPENED ON 2 SYRINGES. ON ONE THE CAP WAS GONE AND THE NEEDLE EXPOSED.
PT HAD AN 18G CATHETER IN L BASILIC VEIN APPROX 14" LENGTH. LEAK AT SITE AND PT HAD PAIN AND ERYTHEMA. CATHETER DISCONTINUED 8/5/96. EXAMINED POST REMOVAL. MISSING PIECE 1CM LONG AT 25CM MARK AND "U" SHAPED TEAR AT 15CM MARK. CATHETER REMOVAL WAS EASY. SPOKE WITH RN WHO INSERTED CATHETER. SHE USED 17G METAL WINGED INTRODUCER. SHE STATED INSERTION WAS EASY. THREADING WAS EASY AND UNEVENTFUL. CALLED RPAC AND VASCULAR SURGEON WHO ORDERED FOLLOW-UP X-RAYS (CXR, L SHOULDER, L ARM) TO FURTHER ASSESS POSSIBLE LOCATIONS OF MISSING SHARD OF SILICONE CATHETER. ALL X-RAYS NEGATIVE PER DR. NO FOREIGN BODY FOUND. PT HAD MIDLINE CATHETER INSERTED AT MD OFFICE BY RN, OBSERVING WAS RPAC. (PRIMARY CARE PHYSICIANS ASST). PT HAS LYME AND BELL'S PALSY AND HEPATITIS C ON ROCEPHIN 28M IV PB Q24 HOURS SINCE 7/23/96. HAD ON AND OFF S/S PHLEBITIS SINCE 7/24/96 - MD AWARE.
ON 3/13/96, DIFFICULTY WAS ENCOUNTERED IN FLUSHING THE CATHETER. ON 3/14/96, PT COMPLAINED OF SEVERE BURNING IN THE RIGHT CHEST AREA WITH ADMINISTRATION OF MEDICATION. USE DISCONTINUED AND PT UNDERWENT SURGERY ON 3/15/96 FOR REMOVAL OF AND REPLACEMENT. INTERNAL MEMBRANE NOTED TO BE COMPLETELY SEPARATED FROM SURROUNDING PLASTIC.
PT WAS PREPPED WITH BETADINE AND ALCOHOL FOR CATHETER PLACEMENT. PT WAS ANXIOUS AND WAS ON LATEX PRECAUTIONS BUT HAD NO HISTORY OF ADVERSE REACTIONS. UPON VENIPUNCTURE, BLOOD RETURNED. CATHETER WAS ADVANCED OVER 2-3 MINS WITH FLUSHING. SHORTLY AFTER COMPLETION, PT COMPLAINED OF PRESSURE IN HIS HEAD. NOTED FLUSHED FACE. PT PLACED ON BLOW-BY O2 - NOTED FLUSHING ON CHEST AND UPPER EXTREMITIES. BENADRYL GIVEN IV. BP NOTED 73/30. IV FLUID BOLUS GIVEN. BP RETURNED WITHIN 10 MINS TO PRE-PROCEDURE 120/60. PT SYMPTOMS RESOLVED.
PT HAD SUDDEN O2 DESATURATION AFTER PLACEMENT OF A PASSIVE HUMIDIFIER. A SMALL PIECE OF FILTER PAPER FROM INSIDE THE HUMIDIFIER WAS FOUND IN THE PT'S ENDOTRACHEAL TUBE AND WAS REMOVED. PT NEEDED TO BE MANUALLY VENTILATED. O2 SATURATION RETURNED TO NORMAL.
PT WAS UNDERGOING EXCHANGE OF BILATERAL URETERAL STENTS. FIRST STENT OPENED AND USED WITH GUIDEWIRE. STENT PASSED WITHOUT A PROBLEM, HOWEVER, GUIDEWIRE WAS UNABLE TO BE REMOVED AND FELT AS IF IT WERE STUCK. STENT, GUIDEWIRE AND INSTRUMENTS REMOVED. DISTAL END OF GUIDEWIRE (URETER END) APPEARED FRAYED. SECOND STENT WITH ANOTHER CO'S GUIDEWIRE WAS INSERTED WITH SAME DIFFICULTY ENCOUNTERED WHEN ATTEMPTED TO REMOVE GUIDEWIRE. GUIDEWIRE AND STENT WERE REMOVED TOGETHER. GUIDEWIRE APPEARED FRAYED AND PULLED APART AT THE DISTAL END. PROCEDURE WAS COMPLETED USING ANOTHER CO'S STENTS AND GUIDEWIRES WITHOUT PROBLEMS.
CLINICAL STAFF WAS IN THE PROCESS OF DOUBLE VOLUME EXCHANGE TRANSFUSION WHEN CONNECTION BETWEEN BLOOD WARMER CASSETTE AND TUBING TO TRANSFUSION BAG SPLIT, LOSING 100-200CC BLOOD ONTO THE FLOOR AND THE NURSE.
PT WAS SITTING IN THE CONVALESCENT RECLINER WITH THE RECLINER TRAY LOCKED IN PLACE. PT MANIPULATED THE TRAY AND WAS ABLE TO REMOVE TEH TRAY FROM ITS SECURED POSITION. PT THEN STOOD UP AND PROMPTLY FELL ON BUTTOCKS. THERE WAS A QUESTION AS TO WHETHER OR NOT ONE OF THE LATCHES FOR THE TRAY WAS PROPERLY WORKING AT THE TIME THE PT WAS PLACED IN THE RECLINER.
IN PROCESS OF REMOVING UMBILICAL ARTERY CATHETER, CLINICIAN WITHDREW APPROX 1CM EASILY, THEN CATHETER SNAPPED INTO TWO PIECES AT THE 9CM MARK. CATHETER REMAINING IN UMBILICAL ARTERY WAS CLAMPED; PRESSURE APPLIED TO UMBILICUS; AND REMAINDER OF CATHETER WITHDRAWN IN ONE PIECE. ESTIMATED BLOOD LOSS 8CC. 26 WK GESTATION PREEMIE. WEIGHT 945 G.
WHILE ATTEMPTING TO PLACE AN IV, IT WAS DISCOVERED THAT TWO CATHETERS FROM THIS LOT WERE DEFECTIVE. THERE APPEARS TO BE A KNOT IN THE PLASTIC CATHETER SO THAT WHEN IT IS INSERTED INTO THE SKIN, THE CATHETER CRINKLES UP INSTEAD OF SLIDING UNDER THE SKIN.
WHILE ATTEMPTING TO POSITION THE ATTACHED HEAD CLAMP INTO THE STATIONARY TABLE ATTACHMENT, THE HEAD CLAMP SLIPPED OUT OF POSITION CAUSING A 2-INCH LACERATION ON THE PT'S RIGHT TEMPORAL AREA. AREA WAS SUTURED.
PT WAS HAVING OLD KNEE PATELLA PROSTHESIS (IMPLANTED) REMOVED FROM PLACEMENT. 2 BURRS, REGULAR SIZE, BROKE WHILE ATTEMPTING TO REMOVE THE PEGS FROM OLD PROSTHESIS. THIRD ATTEMPT WITH SAME MAKE AND SIZE BURR SUCCEEDED.
DURING ROUTINE DE-BUBBLING OF THREE HEAT EXCHANGERS, STAIR-CASE HEATING RODS PROTRUDED OUT OF HEAT EXCHANGER OUTLET AND OCCLUDED THE LUMEN OF THE CONNECTING CIRCUIT.
SCREW BROKE WHILE ATTEMPTING TO ATTACH PT'S PATELLA TENDON TO TIBIA IN A PROSTHESIS REPLACEMENT SURGERY. UNABLE TO REMOVE BODY OF SCREW; LEFT IN. USED 3 ADD'L SCREWS TO ATTACH TENDON.
VENTRICULAR PACING LOCK FAILURE - UNDERLYING COMPLETE HEART BLOCK. PACEMAKER GENERATOR HAD REVISION DONE.
PACEMAKER NOT PACING AT PROGRAMMED RATE OF 70. HEART RATE CONSEQUENTLY DECREASING TO 40S. ADMITTED TO HOSP, PACEMAKER GENERATOR AND WIRE REPLACED.
WHILE SCREWING IN A SCREW DURING AN ACL RECONSTRUCTION, AN AUDIBLE SNAP WAS HEARD. THE SURGEON DETERMINED THAT THE SCREW HAD SPLIT YET IT WAS DOING THE INTENDED JOB OF HOLDING THE PATELLA GRAFT IN PLACE. SO, IT WAS LEFT IN PLACE.
PT HAD MASTECTOMY WITH RECONSTRUCTION AND APPROX. 10 DAYS POST-OP THE IMPLANT WAS MALPOSITIONED AND SOMEWHAT DEFLATED. SHE RETURNED TO SURGERY FOR REMOVAL OF EXPANDER WITH REPLACEMENT WITH A NEW TISSUE EXPANDER.
IN PACEMAKER CLINIC PT WAS SEEN TO INCREASE PROGRAMMED BASE RATE FROM 60-80. UPON INTERROGATION THE VENTRICULAR LEAD IMPEDANCE WAS VERY LOW. DR DECIDED TO REPLACE LEAD AS IT WAS ON LEAD ALERT WITH LOW LEAD IMPEDANCE.
PT PRESENTED TO ER WITH A PRESYNCOPAL EPISODE. SHE DID NOT HAVE ABSOLUTE LOSS OF CONSCIOUSNESS. OVER THE NIGHT IN THE HOSP, THE MONITOR REVEALED COMPLETE VENTRICULAR PACING AND DR EVALUATED THIS AND CONCLUDED THAT THE ATRIAL WIRE WASN'T FUNCTIONING. AS HER VENTRICULAR LEAD WAS UNDER ALERT THE WHOLE SYSTEM WAS REPLACED.
ON 6/2/94, PT UNDERWENT C5-6 AND C6-7 ANTERIOR MICRODISKECTOMY WITH OSTEOPHYTECTOMY WITH ANTERIOR INTERBODY FUSIONS USING TRICORTICAL AUTOLOGOUS BONE GRAFT, FOLLOWED BY C5-7 ANTERIOR SEGMENTAL INTERNAL FIXATION. SIX WEEKS AFTER SURGERY SHE FELT A POP IN HER NECK, AND SHE WAS NOTED TO HAVE A FRACTURED PLATE AT C6-7. SINCE 12/95 OR 1/96, SHE HAS EXPERIENCED INCREASING NECK PAIN AS WELL AS RADICULAR PAIN IN THE RIGHT UPPER EXTREMITY. THE PAIN IS ASSOCIATED WITH NUMBNESS AND TINGLING.
ON ROUTINE PACEMAKER TELEPHONE CHECK 11/16/94 PT WAS FOUND TO HAVE INTERMITTENT FAILURE OF HER VENTRICULAR WIRE TO SENSE AND CAPTIVE. SHE HAD RECENTLY BEGUN TO HAVE PRESYNCOPAL SYMPTOMS WITH WALKING.
ATTEMPTED LT EXT ILIAC ANGIOPLASTY BUT WAS UNSUCCESSFUL DUE TO BALLOON CATHETER BREAK WITH FRAGMENT REMAINING IN VESSEL. THE CATHETER WAS SHEARED OFF AT A DENSELY CALCIFIED AORTIC BIFURCATION. PT WAS TAKEN TO SURGERY FOR EXTRACTION OF THIS FOREIGN BODY AND FOR ILIOFEMORAL BYPASS 3/14/96.
ON 12/12/95, PT UNDERWENT A DECOMPRESSIVE LAMINECTOMY OF L-5; POSTERIOR LUMBAR INTERBODY FUSION WTH CANCELLOUS GRAFT OF L5-S1; VARIABLE SPINE PLATING INTERANAL FIXATION OF L-4 TO S-1; POSTEROLATERAL FUSION WITH AUTOGRAFT AND HARVERSTING OF GRAFT FROM THE RIGHT POSTERIOR ILIAC CREST AND BICORTICAL ALLOGRAFT. ABOUT 2/22/96, PT SNEEZED, FELT A SNAP IN HIS BACK, AND HAD THE INSET OF RADICULAR LEFT BUTTOCKS AND THIGH PAIN. DURING SURGERY ON 3/7/96, BOTH SACRAL SCREWS WERE FOUND TO BE LOOSE. THE L-4 SCREWS WERE REMOVED FOUND TO BE LOOSE. THE L-4 SCREWS WERE REMOVED IDENTIFYING THAT THE TOPS OF BOTH OF THESE TITANIUM VSP SCREWS HAD BEEN SHEARED OFF RIGHT AT THE NUT.
THE PT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION FOUR MONTHS AGO TO STABILIZE A LEFT PROXIMAL HUMEROUS FRACTURE. PT HAD COMPLAINED OF SUBACROMIAL DISCOMFORT, BURSITIS, AND SWELLING OF THE SHOULDER FROM BURSITIS, AND X-RAY SHOWS THAT THE RODS ARE PROTRUDING SLIGHTLY AND IRRITATING THE SUBACROMIAL BURSA AND NEED TO BE REMOVED. PT WAS ADMITTED FOR EXCISION OF RODS.
THE ORIGINAL SURGERY WAS DONE IN ANOTHER STATE. RPTR DOES NOT HAVE ANY INFO AVAILABLE OTHER THAN A CATALOGUE NUMBER OF THE TIBIAL COMPONENT. THE DR REMOVED THE TIBIAL COMPONENT AND PATELLA AND REPLACED THEM WITH A 6628-2-975 AND 2638-5-111. NO OTHER INFO IS AVAILABLE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
LINER DELAMINATED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
PT BEGAN EXPERIENCING KNEE PAIN ONE YEAR AGO. IT WAS DETERMINED DURING SURGERY THAT THE TIBIAL BASEPLATE SHOULD BE REPOSITIONED MORE LATERALLY. THE BASEPLATE WAS REMOVED AND AN APPROPRIATELY SIZED BASEPLATE WAS CEMENTED IN PLACE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
TIBIAL BASEPLATE AND INSERT WERE WORN OUT AND TAKEN OUT. THESE WERE ORIGINAL PCA COMPONENTS. ANOTHER BASEPLATE, INSERT AND TIBIAL WEDGE WERE PUT IN.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
ON 9/15/94, PT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF A LEFT FEMORAL SHAFT FRACTURE. IN 2/95, PT BEGAN TO EXPERIENCE PERSISTENT AND INCREASING LEFT KNEE PAIN. IN 5/95, X-RAY REVEALED AN APPARENT FAILURE OF THE HARDWARE WITH A DELAYED UNION AND MILD VARUS DEFORMITY. THERE WAS SOME BREAKAGE AND PULL-OUT OF THE MORE PROXIMAL ASPECT OF THE HARDWARE. CONSERVATIVE MANAGEMENT WAS UNSUCCESSFUL AND FOLLOW-UP X-RAYS REVEALED SOME  FURTHER DECOMPENSATION AT THE FX. SITE AND IT WAS FELT SHE HAD AN ESTABLISHED NONUNION. ON 3/14/96, PT UNDERWENT HARDWARE REMOVAL. TWO OF THE THREE CERCLAGE WIRES WERE BROKEN, ONE SCREW WAS FRAGMENTED. THE FRACTURE WAS FOUND TO BE VERY UNSTABLE.
DURING CLOSING OF OPERATIVE WOUND A NEEDLE BROKE AND BOTH HALVES WERE LOST IN THE FIELD. THE WOUND WAS EXPLORED AND NO NEEDLES FOUND. POST-OP X-RAY REVEALED 3/4 INCH PIECE OF NEEDLE. THE PT WAS REINTUBATED. THE UPPER SEVEN STAPLES WERE REMOVED AND USING C-ARM GUIDANCE THE NEEDLE WAS IDENTIFIED AND REMOVED. ALL PRODUCTS WITH THE SAME LOT # WERE REMOVED FROM STOCK.
AT THE BEGINNING OF A CARDIOVASCULAR PROCEDURE, AND AFTER THE INDUCTION OF  ANESTHESIA, A PT MONITOR BLANKED AND LOST CONTACT WITH THE PT. THE ANESTHESIOLOGIST HAD TO MONITOR THE PT MANUALLY VIA THE CAROTID PULSE. PROCEDURE COMPLETED.
CHILD WITH FRACTURE OF RIGHT FEMUR. TO OR ON 3/5/96 FOR APPLICATION OF EXTERNAL FIXATOR DEVICE. DISPLACEMENT OF DEVICE NOTED. PT REQUIRED RETURN TO OR ON 3/7/96. DURING PRE-OP MANIPULATION OF 2ND DEVICE, 2ND DEVICE BROKE. THIRD DEVICE THEN PLACED IN PT, SUCCESSFULLY.
PT ADMITTED FOR CORONARY ARTERY ANGIOPLASTY AND CORONARY STENT PROCEDURE FOR TREATMENT OF CORONARY ARTERY STENOSIS. PHYSICIAN UNABLE TO DEPLOY STENT; LOCATION OF STENT UNKNOWN, POSSIBLY EMBOLIZED.
DEFIB WOULD NOT CHARGE ABOVE 50 JOULES OR DISCHARGE. SECOND DEFIB PROCURRED FUNCTIONED NORMALLY.
CAPILLARY TUBES IN FILTER SEPARATED FROM CAP OF FILTER. DIALYSIS MACHINE DETECTED LEAK, SHUT DOWN IMMEDIATELY.
IMPLANT MIGRATED IN RIGHT EYE. LENS (AMPUTATED FOOT) WAS REMOVED AND NEW LENS IMPLANTED.
NEEDLE BROKE OFF WHILE PT WAS BEING SUTURED FROM SURGERY. X-RAYS TAKEN TO DETERMINE LOCATION OF NEEDLE. NEEDLE WAS LOCATED IN EXTRAPERITONEAL AND NOT REMOVED.
DURING PTCA PROCEDURE, THE CORONARY STENT WENT INTO AORTA. UPON THE ATTEMPT TO WITHDRAW THE SYSTEM, THE STENT WAS BENT AND BECAME DISLOCATED FROM THE CATHETER. STENT ENDED UP IN RIGHT POSTERIOR TIBIAL ARTERY. STENT WAS NOT REMOVED.
PT WAS ANESTHETIZED ON FULL CARDIOPULMONARY BYPASS FOR CABG SURGERY. PERFUSIONIST ON LOW FLOWS (500 ML), WAS TOLD BY SURGEON TO GO TO FULL FLOWS. THE PERFUSIONIST TURNED RHEOSTAT UP AND SURGEON NOTICED THAT THE AORTA WAS FLAT AND INFORMED PERFUSIONIST. PERFUSIONIST NOTICED THE PUMP OFF LIGHT WAS ILLUMINATED. IT IS UNCLEAR HOW PUMP WAS INADVERTENTLY TURNED OFF. WHEN THE PUMP WAS TURNED ON, THE SURGEON OBSERVED AIR IN THE AORTIC CANNULA. EMERGENCY RESUSCITATION MEASURES WERE TAKEN, INCLUDING STEEP TRENDELENBURG, SOLUMEDROL AND CANNULATION OF SVC AND RETROGRADE BRAIN PERRUSION FOR 5 MINS DURING HYPOTHERMIA. THE CABG PROCEDURE WAS PERFORMED AFTER THE ABOVE MEASURES COMPLETED.
PT WAS REFERRED TO THE ELECTROPHYSIOLOGY LAB FOR PACEMAKER REVISION DUE TO VOLUNTARY RECALL OF ATRIAL LEAD. LEADS WERE DISCONNECTED FROM THE OLD PULSE GENERATOR AND REMOVED WITH SIMPLE TRACTION FROM THE SUBCLAVIAN VEIN. NEW LEAD AND GENERATOR WERE IMPLANTED WITHOUT COMPLICATION.
AFTER AN UNEVENTFUL INSERTION OF THE PIC CATHETER, TEH GUIDE WAS REMOVED, OBSERVED UNRAVELING, AND EVENTUALLY BROKE, THE PORTION OF THE WIRE REMAINING IN THE CATHETER WAS REMOVED USING HEMOSTATS. BLOOD WAS ASPIRATED FROM THE CATHETER AND THE CATHETER WAS REPLACED.
PT WAS IN SURGICAL INTENSIVE CARE UNIT FOLLOWING CARDIAC BYPASS SURGERY. THE PNEUMOTHORAX TUBE HAD BEEN IN PLACE WITH NO PROBLEMS REPORTED FOR APPROX 24 HRS. AS NURSE TURNED PT AS PART OF NORMAL CARE SHE NOTICED THAT THE TUBING HAD SEPARATED FROM THE ADAPTER, APPARENTLY DUE TO THE FAILURE OF THE FACTORY SEAL. THE TUBE WAS IMMEDIATELY CLAMPED. A NEW PNEUMOTHROAX TUBE WAS INSERTED. THERE WAS NO APPARENT HARM TO THE PT.
A PT SUFFERING FROM NEURO-MUSCULAR DAMAGE WAS RECEIVING ELECTRICAL STIMULATION TO HIS ARM FOR MUSCLE EXERCISE. OUTPUT OF THE DEVICE WAS APPLIED THROUGH TWO EMPI ELECTRODES PLACED ON THE LOWER FOREARM BETWEEN THE WRIST AND ELBOW. STIMULATOR OUTPUT WAS INTENSITY 64 (90VP/P AT 2400 HZ). THE UNIT'S MAXIMUM OUTPUT IS INTENSITY 99. THE MFR STATED THAT 64 IS A HIGHER OUTPUT THAN THEY RECOMMEND.
PT WAS REFERRED FOR TRANSVENOUS ICD LEAD REVISION BECAUSE OF DOCUMENTED OVERSENSING 9 MONTHS AFTER SUB-PECTORAL ICD IMPLANT. PT WAS PREPPED IN USUAL STERILE FASHION. AN INCISION WAS MADE THROUGH OLD WOUND AND PULSE GENERATOR WAS REMOVED WITHOUT DIFFICULTY. THE LEAD WAS FOUND TO BE FRACTURED AT THE HEADER OF THE PULSE GENERATOR JUST AS THE INSULATION IS ATTACHED TO THE TERMINAL PIN. LEAD WAS REMOVED FROM THE RIGHT VENTRICLE WITHOUT DIFFICULTY. A NEW PACING/DEFIBRILLATION LEAD WAS POSITIONED AND TESTED WITHOUT PROBLEMS.
PT WAS REFERRED FOR PACEMAKER REVISION DUE TO RECENT PACEMAKER INTERROGATION WHICH REVEALED FAILURE TO SENSE INTRINSIC R WAVE AT THE MAX SENSITIVITY SETTING OF THE PULSE GENERATOR. DURING THE REVISION THE EXISTING LEAD WAS TESTED AND FOUND TO HAVE AN R WAVE SENSING AMPLITUDE OF 9.0 MV. LOSS OF SENSING OCCURRED AT 10.0 MV. THE LEAD IMPEDENCE AND PACING THRESHOLDS WERE SATISFACTORY. IT WAS DECIDED TO USE THE EXISTING LEAD BUT CHANGE THE PULSE GENERATOR DUE TO SIGNIFICANT BATTERY DEPLETION. THIS WAS DONE WITHOUT PROBLEMS OR COMPLICATIONS.
PT WAS REFERRED FOR TRANSVENOUS ICD REVISION AFTER PATCH LEAD WAS FOUND FRACTURED DURING ROUTINE RADIOLOGIC STUDY. PT WAS PREPPED AND DRAPED IN THE USUAL FASHION AND THE DEVICE WAS EXPLANTED WITHOUT DIFFICULTY. THE PATCH LEAD WAS COMPLETELY FRACTURED AND THE DISTAL PORTION WAS REMOVED WITHOUT DIFFICULTY. REVISED DEVICE WAS TESTED WITHOUT COMPLICATIONS OR PROBLEMS.
VENTILATOR WAS NOT WORKING. THE ALARM SOUNDED. PT WAS FOUND CYANOTIC.
RN UNABLE TO REMOVE CATHETER, PT SENT TO EMERGENCY ROOM FOR REMOVAL. ER INSERTED A STENT, BALLOON WAS DEFLATED AND A NEW CATHETER WAS INSERTED WITHOUT DIFFICULTY.
PLACED A CATHETER IN R BASILIC VEIN. WITHIN 2 MINS PT HAD FLUSHED HEAD, NECK, ARMS, LIGHT HEADED, FELT PT WAS SHORT OF BREATH, AWAKE, ALERT, ANXIOUS AND COMPLAINING OF SOMETHING BEING TERRIBLY WRONG. RPTR TOOK OUT THE LINE, GAVE 50 MG BENADRYL BY MOUTH. WITHIN 5 MINS THE PT WAS FEELING MUCH BETTER. 15 MINS LATER PT HAD HIVES ON LOWER LEGS. OBSERVED PT FOR 40 MINS THEN PT WENT HOME. NOT SHORT OF BREATH, FLUSHED OR ANXIOUS.
PT WAS USING FOLDING WALKER ON 6/11/96 IN THE EVENTING. THE WALKER BROKE AT A WELDED JOINT. PT FELL AND HAD PAIN IN THE RIGHT UE. FAMILY TOOK THE PT TO THE ER AT GENERAL HOSP ON 6/13/96. (PT WAS FEELING BETTER SO THE PT WAS NOT TAKEN IMMEDIATELY. PT WAS DIAGNOSED AS HAVING A FRACTURED PELVIS AND WAS TO BE RELEASED ON 6/14/96. PT HAD AN UNSCHEDULED (AND UNRELATED TO FALL) SURGERY. PT HAS A PRIMARY DIAGNOSIS OF METASTATIC CANCER. THIS INFO WAS REPORTED BY HOME HEALTH AIDE AS REPORTED BY FAMILY.
RPTR WAS GIVING A TREATMENT USING THE DEVICE. AFTER 10 TO 12 MINS SHE EXPERIENCED A METALLIC TASTE WHICH LASTED A FEW DAYS. SHE CALLED THE DISTRIBUTOR WHO SAID SHE HAD HEARD OF THIS TYPE OF COMPLAINT BUT HAD NO IDEA HOW THIS REACTION OCCURRED. RPTR HAS METAL CAPS IN HER MOUTH AND BELIEVES THAT PERHAPS THIS IS WHAT CAUSED THE REACTION. RPTR ALSO EXPERIENCED STOMACH PROBLEMS (NAUSEA AND INCREASED ACID), DIZZINESS AND NUMBNESS OF HER FACE. THE INCREASED ACID, SHE UNDERSTANDS, IS DUE TO METAL OXIDATION UNDER MILD ELECTRICAL FIELD (IONIZATION). RPTR WAS ADVISED TO DRINK WATER AND MILK (AFTER ANTACIDS DID NOT WORK) AND THIS WAS HELPFUL. IN APRIL AND MAY RPTR OBTAINED MORE CLIENTS AND INCREASED HER WORKING HRS FROM 1 HR PER WEEK TO APPROX 5-6 HRS PER WEEK AND BECAME VERY WEAK WITH ITCHING OF HER BACK/IRRITATION OF THE SKIN OF HER BACK. SHE WAS SEEN BY A DERMATOLOGIST WHO SAID IT WAS "PROTEIN DEPOSITS." SHE WAS GIVEN MEDICATION BUT ITCH STOPPED AFTER RPTR CANCELLED HER CLIENTS. SHE IS FEELING BETTER NOW BUT STILL HAS SOME RESIDUAL NUMBNESS OF THE FACE. RPTR ALSO HAD 3 CLIENTS WHO EXPERIENCED ELECTRIC SHOCK WHILE BEING TREATED. IF RPTR WAS DOING A TREATMENT ON CLIENT WITH METAL CAPS IN THE MOUTH SHE FELT EVEN WORSE DURING THE TREATMENT. ACCORDING TO RPTR, THE TRANSDERMAL ELECTROLYSIS DEVICE HAS 5 TO 6 TIMES MORE CURRENT THAN ELECTROLYSIS DEVICES USING NEEDLES.
VISITING NURSE PLACED NEEDLE INTO CAP, STARTED TO INJECT LASIXHEARD A CRACK. CLAMPED OFF LINE, WITHDREW NEEDLE AND SYRINGE, NEEDLE INTACT. CHECKED CAP, LOOKED DAMAGED. PULLED THE LINE. VISITING RN STAYED WITH PT 1/2 HOUR. M.D. NOTIFIED; PT HAD NO PAIN OR DISCOMFORT.
RPTR FELT PAIN AND WENT TO THE DR. AN X-RAY WAS TAKEN WHICH REVEALED THE CATHETER WAS BROKEN. RPTR HAD TO UNDERGO REVISION OF THE SYSTEM. DURING SURGERY, DR DISCOVERED THAT THE CATHETER HAD BROKEN IN THE MIDDLE. HE TRIED TO GET THE CATHETER OUT BUT WAS UNABLE TO DISLODGE IT. DR INSERTED NEW CATHETER.
PROTOTYPE BUTTON FOUND TO BE ENTRAPPED IN GASTRIC WALL. VIA EGD, BUTTON BASE DISLODGED FROM WALL, TURNED 1/4. WILL MONITOR ON OUTPATIENT BASIS. THIS DEVICE WAS NOT IMPLANTED AT FACILITY.
DR WAS UNABLE TO REMOVE GASTROSTOMY TUBE. PT SCHEDULED FOR EGD WITH GASTROSTOMY TUBE REMOVAL UNDER GENERAL ANESTHESIA.
POST OPERATIVE PNEUMOPERITONEUM 2 DEGREES TO RUPTURED ASCENDING COLON FOLLOWING COLONOSCOPY WITH POLYPECTOMY.
DR HAS SEEN PT OVER THE PAST 6-8 YEARS. HE HAS A PAST HISTORY OF CERVICAL INTRASPINAL LIPOMA THAT HE HAS HAD SURGERY ON A FEW OCCASIONS. HE HAS DEVELOPED SEVERE SPASTICITY AND RECENTLY UNDERWENT BACLOFEN PUMP PLACEMENT. HE WAS FOUND TO HAVE A FRACTURE IN THE LINE OF THE BACLOFEN PUMP. HE IS CURRENTLY ADMITTED FOR OUTPATIENT OPERATION TO REPLACE THE BACLOFEN PUMP TUBING.
A 67-YR-OLD WHITE FEMALE WAS BROUGHT TO THE HOSP FOR REVISION OF SPINAL CORD STIMULATING ELECTRODE. SHE HAD HAD A FALL, HAD REPLACEMENT OF THE GENERATOR A LITTLE OVER A MONTH AGO. THE SYSTEM FUNCTIONED FINE FOR A COUPLE OF WEEKS, THEN SHE AGAIN HAD FAILURE. THE GENERATOR FUNCTIONING. RPTR WAS GETTING SOME STIMULATION IN THE BACK AND ALTHOUGH X-RAYS SHOW NO BREAK IN THE LEAD SYSTEM RPTR FEELS STRONGLY THAT THE ELECTRODE HAS FAILED.
SURGICAL REMOVAL OF FAILED (DEFLATED SALINE IMPLANT) BREAST IMPLANT.  PHYSICIAN NOTIFIED STAFF HE WOULD RETURN IMPLANT TO MFR AS THEY HAD SENT HIM A REPLACEMENT AT NO CHARGE.
H&P STATES "CURRENT STIMULATOR STOPPED WORKING X 1 WK AGO."
PT WAS ADMITTED WITH A PREOPERATIVE DIAGNOSIS OF SEPSIS, INFECTED CENTRAL LINE. THE CENTRAL VENOUS CATHETER WAS SURGICALLY REMOVED FROM THE PT AND IT WAS DISCOVERED THAT THERE WAS A HOLE IN THE CATHETER THAT CONTRIBUTED TO THE INFECTION. THIS CATHETER WAS IMPLANTED AT ANOTHER MEDICAL CENTER.
BALLOON WAS INTRODUCED INTO DIALYSIS A/V GRAFT OF PT'S LEFT FOREARM USING SHEATHLESS TECHNIQUE. FIRM FORCE WAS NEEDED TO CANNULIZE VESSEL OVER GUIDE WIRE. UPON EXTRACTION THE BALLOON BECAME SEPARATED FROM THE SHAFT, REQUIRING SNARE WIRE RETRIEVAL FROM VESSEL. THE BALLOON HAD ALSO BURST DURING INFLATION PERIOD. THE PRESSURE WAS BETWEEN 15 & 18 ATMS. (MAX RECOMMENDED ATM IS 15).
CUTTING LOOP OF ELECTRODE CAME APART. CASE WAS IN PROGRAM 30 MINUTES @ THAT TIME.
PT WAS UNDERGOING LEFT LAPAROSCOPIC HERNIA REPAIR. DURING TROCAR INTRODUCTION, AFTER THE ABDOMEN INSUFFLATED WITH CO2, AND INJURY WAS SUSTAINED TO THE RIGHT COMMON ILIAC ARTERY AND VENA CAVA. EXPLORATION OF THE FEMORAL ARTERY, REPAIR OF LACERATIONS OF THE RIGHT COMMON ILIAC ARTERY, VENA CAVA, AND INTRAOPERATIVE ARTERIOGRAM, WERE ACCOMPLISHED. SUBSEQUENTLY, POPLITEAL THROMBOENDARTERECTOMY, INTRAOPERATIVE ANGIOGRAM AND REVISION OF ILIAC GRAFT WERE PERFORMED.
A PT WAS BEING TAKEN OUT OF BED BY TWO NURSES WITH THE LIFT. THE NECK OF THE LIFT BENT BACK, SWUNG AROUND AND TOPPLED OVER. THE PT WAS CAUGHT IN MID-AIR. THE LIFT TILTED AND A NURSE STRAINED HER ARM WHILE ATTEMPTING TO PROTECT THE PT. THIS LIFT WAS REVERSED DUE TO IMPROPER SETUP. THIS LIFT TILTS EASILY EVEN WHEN CORRECT TECHNIQUES ARE USED; AND THE SUPPORT FOR THE TRAPEZE IS AT AN ANGLE AND EASILY BECOMES LOOSENED FROM THE BASE.
2/5/96, 8:45. DURING TRANSFER OF THIS RESIDENT TO WHEELCHAIR FROM BED VIA LIFT. STRAP BROKE CAUSING RESIDENT TO FALL ONTO FLOOR. RESIDENT SENT TO HOSP, X-RAY WITH DIAGNOSIS OF FRACTURE OF LEFT LEG GREATER TROCHANTER AND SEEN BY ORTHOPEDIC SURGEON. DR WITH NO NEED FOR SURGERY, TREATMENT: BEDREST.
THE HYPERAL RATE OF FLOW DID NOT CORRESPOND WITH PRODUCT DELIVERED TO THE PT. THE PUMP WAS TESTED FOUR TIMES AT DIFFERENT VOLUME SETTINGS. ON THE FOURTH ATTEMPT TO TEST THE PUMP IT WOULD EITHER RESET FOR NO APPARENT REASON, OR GO INTO A CONTINUOUS ALARM WHICH CANNOT BE RESET. AFTER REPEATED ATTEMPTS THE PUMP CONTINUES TO BEHAVE ERRATICALLY AND WILL NOT OPERATE.
INTRAVASCULAR CATHETER SHEATH IN USE DURING ARTERIOGRAPHY FOR CLAUDICATION. AFTER COMPLETION OF AORTA WITH RUNOFF, CATHETER SHEATH NOTED TO BE SHEARING WITH MULTIPLE FRAGMENTS EMBOLIZING DISTALLY. AFTER SEVERAL ATTEMPTS TO REMOVE SHEATH WITH SNARE WIRE, SMALL ARTERIOTOMY WAS PERFORMED AND THE SHEATH REMOVED UNDER DIRECT VISION AFTER DISTAL OCCLUSION OF FEMORAL ARTERY.
PHYSICIAN WAS EVALUATING CO'S PROSTHESIS AND INSTRUMENTS IN A TOTAL HIP REPLACEMENT. 13MM MODULAR DISTAL BROACH TIP WAS NOT RETRIEVABLE FROM THE RIGHT FEMORAL CANAL DURING SIZING INSTRUMENTATION. FEMORAL PROSTHESIS WAS CEMENTED.
THE PT WAS BEING DIALYZED IN THE ACUTE UNIT. SHE WAS HOSPITALIZED WITH SEPSIS AND ENDOCARDITIS WITH DOCUMENTED VEGETATION ON THE AORTIC VALVE. DURING HER TREATMENT THE MACHINE ALARMED HIGH VENOUS PRESSURE. WHILE TRYING TO RETURN THE PT'S BLOOD, SHE BECAME MORE SOB. IT WAS NOTED THE BLOOD PUMP SECTION OF THE LINE HAD DOUBLED UP ON ITSELF. THE PT ARRESTED BUT WAS RESUSCITATED WITH SUCCESS.
ON 5/12/96 THE PT SUSTAINED A LEFT ULNAR AND RADIUS FRACTURE. AN OPEN REDUCTION WITH PLATE AND SCREW FIXATION WAS PERFORMED. ON ADMISSION TO THIS FACILITY, PRE-OP DIAGNOSIS IS POSSIBLE. SPONTANEOUS FRACTURE OF RADIAL PLATE. ADMISSION TO FACILITY 6/12/96.
LVAD STOPPED PUMPING ON 5/26/96 AT 10 P.M. AFTER 34  DAYS OF IMPLANTATION. CONSOLE CHANGED OUT BUT THE SAME PROBLEM OCCURRED WITH THE NEW DRIVE SYSTEM. THE PT'S CARDIAC OUTPUT FELL FROM 8 TO LESS THAN 1.5. EXPLANTED LVAD 1680 AND REPLACED WITH LVAD 1752 SUCCESSFULLY.
FOUR X 4 GAUZE WAS OPENED AND FOUND TO BE DISCOLORED IN SOME AREAS. THE PACKAGE INTEGRITY WAS INTACT. NO PT HARM.
STAFF NURSE NOTICED A "WHITE SUBSTANCE" INSIDE THE IV TUBING WHEN THEY HOOKED IT TO AN IV BAG. NO PT HARM.
A PT HAD A SALINE LOK IN PLACE WITH A BLUNT NEEDLE LOCATED IN THE SALINE LOK. THE BLUNT NEEDLE BROKE OFF AT THE HUB WHEN THE PT WAS MOVING ABOUT IN BED.
IV CATHETER BROKE WHEN PT WAS MOVING FROM BED TO A CHAIR. NO PT HARM.
PT SUSTAINED A 1ST DEGREE BURN ON RIGHT UPPER THIGH FOLLOWING USE OF DEVICE DURING OPERATIVE PROCEDURE. REQUIRED NO FURTHER TREATMENT.
WHILE BEING TRANSFERED VIA LIFT, RESIDENT FELL OUT OF SLING. 2 DEGREE EQUIPMENT FAILURE WITH LEGS CLOSED DURING TRANSFER. RESIDENT SUSTAINED A BLACK EYE.
PT EXPERIENCED EPISODE PRIOR TO ADMISSION WHERE DEVICE DID NOT FUNCTION PROPERLY. AFTER THIS EPISODE, THE DEVICE WOULD NOT INFLATE. ADMITTED FOR REPLACEMENT OF ENTIRE PROSTHESIS, AS UNABLE TO DETERMINE LOCATION OF LEAK.
PT WITH R DISTAL SUPRACONDYLAR FRACTURE 1/95 HAD HARDWARE PLACED ELSEWHERE. PERSISTENT PAIN FOLLOWING PROCEDURE WITH SUDDEN INTENSE PAIN 8 DAYS PRIOR TO ADMISSION. PRESENTED FOR X-RAY WHICH REVEALED FRACTURE OF HARDWARE (PLATE AND 1 SCREW) 7 CM PROXIMAL TO JOINT LINE. SURGICAL PROCEDURE 4/30/96 TO REMOVE FRACTURED HARDWARE AND REPLACE WITH CO'S FEMORAL ROD.
UPON PLACING PHACO HANDPIECE IN EYE, DR NOTICED SHARP PIECES OF METAL IN THE EYE.
SURGEON FOUND PIECE OF METAL ON EYE UPON INITIATION OF PHACO HAND PIECE.
PT HAD SURGERY 5/15/96, 6/13/96 10:00 AM. RECEIVED CALL FROM DR STATING SHE JUST EXAMINED PT AND CAN SEE PIECES OF METAL IN PT'S EYE. PT HAS NO COMPLAINTS.
WHILE PT WAS RECEIVING TREATMENT FROM A STIMULATOR, THE UNIT SENT STRONG AMOUNTS OF MILLIAMPS. THE OUTPUT BUTTON WAS NEVER TOUCHED. THE TRANSMISSION WAS PRODUCED FROM TURNING THE MACHINE ON ONLY. EQUIPMENT WAS DETERMINED TO BE MALFUNCTIONED. THE PT WAS TREATED WITH A HOT PACK. THERE WAS NO SKIN DISCOLORATION OR INJURIES OTHER THAN A TEMPORARY SHOCK THROUGH 4 ELECTRODES PLACED OVER HER LOW BACK MUSCULATURE BILATERALLY.
PHYSICIAN IS CONCERNED THAT A METAL FRAGMENT MIGHT HAVE COME OFF THE PHACO TIP SINCE A .2MM PARTICLE WAS FOUND IN A SECOND PT'S EYE DURING CATARACT SURGERY (SEE CO'S MCI REPORT SENT WITH THIS REPORT). AFTER REPORTS OF TESTING THERE SHOULD BE NO PROBLEM FOR THE PT, PER PHYSICIAN AND FOLLOW-UP WILL CONTINUE. NO FRAGMENTS OBSERVED WITH THIS PT.
A .2MM METALIC PARTICLE LEFT IN PT EYE DURING SURGERY TO REMOVE CATARACTS. PHYSICIAN DID REMOVE FRAGMENT AND RETAINED IT FOR MFR TO TEST FOR TOXICITY AND ANALYSIS OF ORIGIN. BASED ON TESTS CONCLUDING NO TOXICITY THERE SHOULD BE NO PROBLEM FOR THE PT AND PHYSICIAN HAS SEEN NO PROBLEM, TO DATE, WITH PT.
CATHETER BEING REMOVED IN PT'S HOME. AFTER REMOVING SUTURE AT EXIT SITE, STEADY TRACTION APPLIED TO CATHETER. AS CUFF BECAME VISIBLE, CATHETER SNAPPED. RETAINED INTERNAL PORTION OF CATHETER RETRACTED INSIDE EXIT, BUT COULD BE PALPATED. ATTEMPTS TO REACH END OF CATHETER UNSUCCESSFUL. PRESSURE MAINTAINED OVER CATHETER TRACT AND PT TRANSPORTED TO ER WHERE CATHETER WAS REMOVED. SMALL INCISION AT EXIT SITE REQUIRED TO RETRIEVE CATHETER. PT EXPERIENCED NO ACUTE DISTRESS.
PT HAD NEEDLE LOCALIZATION AND BREAST BIOPSY PERFORMED ON 1/18/96. ON 4/9/96, A SECOND BIOPSY WAS PERFORMED AND A TWO INCH SEGMENT OF THE WIRE USED FOR NEEDLE LOCALIZATION WAS FOUND IN THE BREAST. IT APEARS THIS SEGMENT BROKE OFF DURING TISSUE DISSECTION ON 1/18/96.
PHYSICIAN APPLIED A PAIR OF SIZE 8 STERILE GLOVES AND STATED HIS HANDS BEGAN TO BURN. GLOVES WERE REMOVED AND WASHED, BURNS NOTED ON RIGHT HAND, THUMB, RINGFINGER, AND MIDDLE FINGER. SILVADENE OINTMENT APPLIED.
SCHEDULED FOR ELECTIVE TOTAL ABDOMINAL HYSTERECTOMY AND MARSHALL-MARCHETTI PROCEDURE. PT INDUCED, UNABLE TO VENTILATE PT WITH DEVICE CIRCUIT, ORAL AIRWAY INSERTED. UNABLE TO VENTILATE, MEDICATION GIVEN, UNABLE TO VENTILATE. INTUBATED, UNABLE TO VENTILATE. PT REINTUBATED, UNABLE TO VENTILATE. CRICOTHYROTOMY PERFORMED, UNABLE TO VENTILATE WITH JET INSUFFLATION, SURGICAL CRICOTHYROTOMY PERFORMED. VENTILATION POSSIBLE WITH AMBU BAG.
BONE MARROW BIOPSY NEEDLE BROKE OFF DURING PROCEDURE. RETAINED NEEDLE FRAGMENT LEFT IN PT. PT BEING OBSERVED POST X-RAY EVALUATION.
FOURTEEN YR OLD PT CALLED STATING THAT PERIPHERAL IV FELT FUNNY. ATTEMPTED TO FLUSH IV. PT STATED IT FELT WET. SMALL TEAR NOTED IN TRANSPARENT DRESSING WITH TRACES OF BLOOD. TAPE AND TRANSPARENT DRESSING REMOVED AND HUB OF CATHETER WAS FOUND NOT TO BE ATTACHED. CATHETER TIP NOT WFOUND. SUBSEQUENTLY FOUND IN FOREARM BY RADIOGRAPHIC STUDY. ATTEMPTS WERE MADE ON 3/14 TO REMOVE WITH ULTRASOUND AND FLUOROSCOPY. REQUIRED SURGICAL REMOVAL IN OR. PT RECEIVED ADD'L DOSE OF HUMATE P UPON REMOVAL OF SUTURES. SCARRING LIKELY, POSSIBLE NEED FOR FURTHER SURGERY.
DURING CATHETERIZATION, WIRE BECAME LOCKED IN 90% OCCLUDED ARTERY. TIP OF WIRE UNRAVELLED AND BROKE OFF IN ANTERIOR LEFT DESCENDING ARTERY. APPROX 16 CM LEFT IN PT. PT UNDERWENT EMERGENCY OPEN HEART SURGERY. PT DISCHARGED TO HOME 1/20/96.
PT UNDERGOING AMBULATORY PROCEDURE UNDER NERVE BLOCK. NITROUS OXIDE FLOW METER WAS TURNED ON TO PROVIDE SUPPLEMENTAL ANESTHESIA AND PT IMMEDIATELY BECAME AGITATED AND BEGAN HYPERVENTILATING. END-TIDAL CO2 IDENTIFIED SUDDEN RISE ON CO2 CONTENT. PT GIVEN IMMEDIATE O2 BY FACE MASK AND VALUES BECAME NORMAL. IMMEDIATE INVESTIGATION IDENTIFIED SUSPECT TANK LABELLED NITROUS OXIDE. IMMEDIATELY DISCONNECTED, REPLACED WITH RESERVE TANK, (AFTER TESTING) AND DISABLED TOP PREVENT POSSIBILITY OF FURTHER USE. ENTIRE FACILITY MEDICAL GAS SYSTEM SUBSEQUENTLY PURGED. PT DID FINE BUT KEPT OVERNIGHT FOR OBSERVATION.
VENTILATOR INITIALLY ALARMED PROXIMAL PRESSURE HOSE DISCONNECT. HOSE RECONNECTED AND THEN VENT SCREEN WENT BLANK. PT WAS BAGGED FOR VENTILATORY SUPPORT. VENT BEGAN TO SMOKE. IMMEDIATELY REMOVED FROM SERVICE AND PT ON ANOTHER VENTILATOR. NO ADVERSE OUTCOME.
PT HAD A UNIPOLAR PACING LEAD. PRESUMED DAMAGED LEAD WAS EXTRACTED AND REPLACED DUE TO HIGH IMPEDANCE. NO ADVERSE EVENT.
PT HERE FOR TOTAL HIP PLACEMENT. ACETABULAR INSERT DID NOT FIT PROPERLY AND A BACKUP HAD NOT BEEN SUPPLIED. THEREFORE A DIFFERENT, LESS PREFERABLE TYPE HAD TO BE USED FOR THE PT. SURGEON FELT THERE WAS A DEFECT IN THE PRODUCT. NO HARM TO PT.
GAS STERILIZER MALFUNCTIONED, RESULTING IN 3 ITEMS BEING USED IN CARE OF THREE PTS NOT BEING COMPLETELY STERILIZED. CO EXAMINED, REPAIRED AND TESTED THE STERILIZER TO VERIFY APPROPRIATE OPERATION.
THE LEAD WAS TAKEN OUT OF SVC DUE TO AN INSULATION DEFECT. THE SEGMENT WITH THE INTERRUPTION IS STILL IN THE PT DUE TO CLINICAL REASONS AND PLACES THE PT AT NO RISK.
PT WAS ADMITTED FOR REMOVAL OF FRACTURED ICD LEAD.
A 32 YR OLD FEMALE UNDERWENT SURGERY ON 1/22/96 FOR A LAPAROSCOPIC CHOLECYSTECTOMY AND ESOPHAGOGASTRODUODENOSCOPY. WHEN TROCAR WAS REMOVED AT THE END OF THE LAPAROSCOPIC CHOLECYSTECTOMY, IT WAS NOTICED THAT A FRAGMENT WAS BROKEN OFF THE TIP. THE SURGEON EXPLORED THE INCISION, AND MADE THE INCISION LARGER IN ORDER OP RETRIEVE THE FRAGMENT. THE FRAGMENT WAS RETRIEVED AND THE PT TOLERATED THE PROCEDURE WELL. [*]
PT REQUIRED SURGICAL EXPLANTATION OF FRACTURED ICD LEAD.
NONTHORACOTOMY LEAD SENDING INAPPROPRIATE ELECTRICAL DISCHARGES. LEAD WAS SURGICALLY EXTRACTED, NEW LEAD REPLACED.
A 44 YR OLD FEMALE UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON 3/25/96. A SIZE 15 FR. DRAIN WAS INSERTED BELOW THE LIVER IN THE HEPATIC BED OF THE GALLBLADDER AREA. IT WAS BROUGHT OUT AND SUTURED IN PLACE AND CONNECTED TO A BULB SUCTION. ON 3/26/96, IN AN ATTEMPT TO REMOVE THE DRAIN, THE TUBING BROKE. THE PT WAS TAKEN TO SURGERY FOR REMOVAL OF THE RETAINED DRAIN FRAGMENT. THE DRAIN TRACT IN THE UPPER QUADRANT OF THE ABDOMEN WAS EXPLORED AND THE DRAIN WAS FOUND AT THE LEVEL OF THE FASCIA. THE DRAIN HAD BEEN BROKEN AT THIS LEVEL WHERE IT HAD BEEN CAUGHT BY A FASCIAL SUTURE. THE DRAIN FRAGMENT WAS IDENTIFIED AND EXTRACTED.
BROKEN LEFT FEMORAL STEM RESULTING IN SURGICAL PROCEDURE FOR REPLACEMENT.
DURING A ROUTINE TONSILLECTOMY AND ADENOIDECTOMY, A PT RECEIVED A CAUTERY BURN TO THE RIGHT ORAL COMMISURE. THE BURN LEFT A SMALL DISCOLORED AREA IN THE RIGHT CORNER OF THE MOUTH. PLASTIC SURGERY WAS CONSULTED TO EVALUATE THE BURN. THEIR DECISION WAS TO WAIT AND SEE HOW WELL THE INJURY HEALS BEFORE DECIDING WHETHER ANY CORRECTIVE SURGERY IS NECESSARY. THE SURGICAL RESIDEWNT REPORTED THAT, AFTER OBSERVING THE BURN, HE NOTED THAT THE INSULATING SLEEVE ON THE ELECTRODE BLADE HAD NOT BEEN PUSHED ALL THE WAY IN. TESTING BY CLINICAL ENGINEERING SHOWED THAT IT IS DEFINITELY POSSIBLE TO PRODUCE SIGNIFICANT RF LEAKAGE AT THE JUNCTION OF THE PENCIL AND THE ELECTRODE BLADE IF IT IS NOT FULLY INSERTED INTO THE PENCIL. ADD'L TESTING SHOWED THAT LEAKAGE CAN STILL OCCUR EVEN IF THE BLADE IS FULLY INSERTED AND A CONDUCTIVE FLUID (SUCH AS D5W) IS POURED OVER THE PENCIL AND BLADE JUNCTION.
WHEN ELECTROSURGICAL UNIT GROUNDING PAD WAS REMOVED FROM PT, NOTICED BURN ON LEFT THIGH. DR NOTIFIED, LOOKED AT BURN AND DRESSED IT WITH BACETRACIN OINTMENT, ULFA AND KIREX. BURN APPEARS TO BE ABOUT 3 INCHES ROUND AND BLACK IN COLOR. PT MOVING BOTH FEET AND LEGS.
A PT ADMITTED TO RULE OUT CHEST PAIN WAS DISCOVERED ON THE FLOOR AND UNRESPONSIVE. THE PT'S ECG MONITOR SCREEN WAS BLANK, EVEN THOUGH IT WAS REPORTEDLY PLUGGED INTO A WORKING AC OUTLET. THE PT WAS CONNECTED TO AN EMERGENCY CARDIAC MONITOR AND FOUND TO BE IN NORMAL SINUS RHYTHM. THE MONITOR SOMEHOW LOST AC POWER AND HAD SWITCHED TO BATTERY OPERATION. WHEN THE BATTERY WAS EXHAUSTED, THE MONITORING CEASED, AND THE SYSTEM FAILED TO ALERT THE STAFF THAT THE PT WAS NO LONGER BEING MONITORED. THE MONITOR WAS TESTED AND FOUND TO BE WORKING NORMALLY AND WITHIN MFR SPECIFICATIONS. FURTHER TESTING REVEALED THAT THE CENTRAL STATION'S RESPONSE TO THE LOSS OF AC POWER IS TO DISPLAY A SMALL FLASHING MESSAGE "LOW BATTERY" FOLLOWED BY "NO COMM" WHEN THE MONITOR'S BATTERY DISCHARGES. THE CLINICAL STAFF ASSUMED THAT THE MONITOR SYSTEM WOULD ALARM FOR ANY PROBLEM RESULTING IN A LOSS OF ECG SIGNAL. IT IS NOT CLEAR WHY THE CENTRAL STATION AND THE ASSOCIATED PAGING SYSTEM DOES NOT RESPOND TO THE LOSS OF POWER BY GENERATING ANY SIGNIFICANT AUDIBLE OR VISUAL ALARM.
A PHYSICIAN FOUND A PT UNRESPONSIVE WITH OXYGEN SATURATION IN THE 40S. THE PT'S CONDITION RETURNED TO NORMAL AFTER RECEIVING OXYGEN. CLINICIANS SUSPECT AN ADVERSE REACTION TO PAIN MEDICATION OR OVER DELIVERY FROM A PCA PUMP.
DEFECTIVE IVC FILTER WAS FOUND ON KUB, TAKEN 7/5/96. IVC FILTER WAS PLACED ON 6/26/96. KUB ON 7/5/96 FOUND FILTER AGAINST LEFT WALL OF VENA CAVA WITH POSSIBLE PERFORATION. NO LEAKING NOTED. NO ATTEMPT AT RETRIEVAL AT THIS TIME.
FOUR NEEDLES BENT DURING ATTEMPTED SUBCLAVIAN VEIN CANNULATION. FOURTH NEEDLE PUNCTURED THE PT'S SUBCLAVIAN ARTERY. THE PHYSICIAN STATED THAT HE BELIEVE THE NEEDLES WERE DEFECTIVE.
ANESTHETIC GASES ESCAPED INTO OPERATING ROOM WHILE USING VAPORIZER AND, AS A RESULT, PT EXPERIENCED SOME DEGREE OF AWARENESS DURING THE OPERATIVE PROCEDURE. NO PHYSICAL INJURY IDENTIFIED.
WHEN THE STAPLE GUN WAS CLOSED ON THE LUNG, THE HANDLE OF THE GUN BROKE INTO MANY SMALL PIECES. THE GUN COULD NOT BE OPENED TO REMOVE; THEREFORE, A THORACOTOMY HAD TO BE PERFORMED IN ORDER TO HAVE THE GUN RELEASED.
PT WAS BEING VENTILATED IN SIMV MODE. PT BEING SUCTIONED WHEN MACHINE SHUT DOWN; PT UNHARMED. MED STAFF PRESENT AND PROVIDED MANUAL RESPIRATION ALONG WITH SPONTANEOUS RESP. SVC REP REPORTED THAT INSULATION FROM CABINET HAD BECOME DISLODGED AND BLOCKED. COOLING FAN CAUSING OVERHEATING.
DURING CATARACT SURGERY, ASPIRATING TIP DID NOT FUNCTION APPROPRIATELY WHEN INTRODUCED IN ANTERIOR CHAMBER. THUS RESULTED IN LOSS OF VITREOUS AND/OR ANTERIOR IMPLANT VERSUS POSTERIOR IMPLANT AS PLANNED. NO FURTHER COMPLICATIONS NOTED PRIOR TO DISCHARGE. FOLLOW-UP POST-OP SCHEDULED FOR 6/13/96. INCORRECT ASSEMBLING BY STAFF OF HAND PIECE POSSIBLE.
CUSTOMER REPORTS LACERATIONS IN PT'S THROAT WHICH ARE BELIEVED TO BE CAUSED BY NASOGASTRIC TUBE. NO ADVERSE PT OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT. CO CANNOT DETERMINE WHETHER THIS PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT.
DURING OPEN HEART SURGERY, THE TIP OF THE PLASTIC INSERT BROKE OFF DURING CANNULATION OF THE HEART. THE PIECE WAS UNABLE TO BE LOCATED.
APPROX ONE AND A HALF MONTHS POST PLACEMENT THE PT PULLED THE FEEDING TUBE PARTIALLY OUT OF THE STOMA SITE. FEEDING LEAKED INTO THE PERITONEAL CAVITY RESULTING IN AN INFECTION. SURGICAL RETRIEVAL OF THE DEVICE FOLLOWED AND ANOTHER DEVICE WAS PLACED. THERE WERE NO PT COMPLICATIONS INVOLVED.
DURING A LAP CHOLE PROCEDURE, THE TIP OF THE DISSECTING SPATULA BROKE OFF. IT TOOK THE DR OVER AN HR TO RETRIEVE BROKEN PIECE. PT IS DOING FINE.
ON THREE SEPARATE OCCASIONS (4/6,4/7, AND 4/9) THERE WAS LEAKING OF TWO OF THE CATHETERS AT THE CONNECTION TO THE HUB AND A THIRD CATHETER BROKE OFF AT THE HUB. THE CATHETERS HAD TO BE REMOVED AND NEW CATHETERS REINSERTED.
PT WAS HAVING CARDIOVERSION. PADS WERE IN PLACE. MACHINE WAS SET FOR 360 AND IT FAILED TO DISCHARGE. CHARGE AGAIN BUT AGAIN, FAILED TO DISCHARGE. CHARGED AGAIN BUT AGAIN, FAILED TO DISCHARGE. TSS CAME INTO DEPARTMENT FOR ANOTHER REASON ASKED TO CHECK MACHINE. NURSE WENT TO CATH LAB AND OBTAINED ANOTHER DEFIBRLLATOR. TSS CUT THE POWER OFF, WAITED 10 SEC., THEN TURNED BACK ON. MACHINE FUNCTIONED PROPERLY. FOLLOWING CARDIOVERSION, STAFF MEMBER NOTICED PACER LIGHT WAS ON AND STARTED PACING AT 60. (THIS WAS DONE WITHOUT BEING TOLD TO DO SO BY THE STAFF-STAFF WAS NOT NEAR THE EQUIPMENT AT THIS TIME.
PCA MALFUNCTIONED. PCA WAS CHECKED AND SYRINGE WAS EMPTY AND LINE WAS FILLED WITH AIR. THE PCA DID NOT BEEP TO ALERT STAFF THAT IT WAS EMPTY. PCA BATTERY WAS LOW AND WAS CHANGED. HISTORY INDICATED IT HAD ALARMED X1 AND SILENCED X1. THE ENTIRE PCA LINE WAS FILLED WITH AIR. PCA WAS PULLED OUT OF USE AND SECURED FOR INVESTIGATION.
WHEN REMOVING DISPOSABLE TROCARS-END BROKE OFF OF 12MM SURGICAL TROCAR. PIECES WERE REMOVED BY SURGEON FROM ABDOMEN AND FITTED TOGETHER TO BE SURE ALL PIECES WERE REMOVED. TWO SURGEONS CHECKED PIECES AND AGREED ALL PARTS WERE REMOVED. ACCORDING TO SUREGON, THERE WAS NOTHING ELSE THAT COULD HAVE BEEN DONE AT THAT POINT.
AUTO FILL FAILURE, PUMP QUIT ON PT. CALLED CO TO CHECK. CO FOUND BROKEN IMPELLOR ON KNF MOTOR ASSY. CAUSED MOTOR TO OVERHEAT. CO'S SVC FOUND MOTOR FAN INTERNAL BROKEN OFF SHAFT CAUSING MOTOR TO OVERHEAT AND SHUT DOWN. TESTED UNIT OK.
RESIDENT HAD COMPLETED HER BATH, SHE WAS SITTING IN THE WHIRLPOOL CHAIR IN THE HIGH POSITION WITH THE STRAP FASTENED AROUND HER. THE STRAP POPPED AND THE RESIDENT HIT THE FLOOR. OUTCOME OF FALL - RESIDENT SUSTAINED A LACERATION OF THE FOREHEAD AND POSSIBLE FRACTURES OF BOTH KNEES WHICH WERE UNABLE TO BE DETERMINED DUE TO THE RESIDENT'S CONTRACTURES.
REMOVAL OF FAILED PENILE PROSTHESIS. R AND LEFT SIDE OF THE CYLINDER HAD AN ANEURYSM AND PERFORATION.
NON-FUNCTIONING PENILE PROSTHESIS, REMOVED (CYLINDERS HAD HOLES).
A 67 YR OLD WHITE FEMALE BROUGHT TO THE HOSP TODAY FOR REVISION OF SPINAL CORD STIMULATING ELECTRODE. SHE HAD HAD A FALL, HAD REPLACEMENT OF THE GENERATOR A LITTLE OVER A MONTH AGO. THE SYSTEM FUNCTIONED FINE FOR A COUPLE OF WEEKS, THEN SHE AGAIN HAD FAILURE. THE GENERATOR FUNCTIONING, GETTING SOME STIMULATION IN THE BACK AND ALTHOUGH X-RAYS SHOW NO BREAK IN THE LEAD SYSTEM RPTR FEELS STRONGLY THAT THE ELECTRODE HAS FAILED.
DURING A TRAN-URETHAL RESECTION OF THE PROSTRATE, A 27FR. CONTINUOUS FLOW RESECTORSCOPE LOST ITS WHITE PLASTIC END. PHYSICIAN NOTICED WAS RETRIEVED FROM THE BLADDER SMALL CHIP NOT FOUND.
TIP OF RESECTOSCOPE INNER SHEATH SEPARATED IN PT ON 5/14/96, SMALL CHIP NOT FIUND; SECOND INCIDENT ON 7/15/96.
REMOVAL OF THE WIRES AND GRIPPER LEFT HIP (DIAGNOSIS - BROKEN TROCHANTERIC WIRES LEFT HIP.
PATELLAR COMPONENT REMOVED FROM RIGHT KNEE DUE TO ASEPTIC LOOSENING. PATELLA RIGHT TOTAL KNEE (PER REP FAILED METAL BACKED PATELLA). OPERATION: REVISION OF PATELLAR PROSTHESIS TO POLYETHYLENE PROSTHESIS.
REMOVAL OF DEFECTIVE PENILE PROSTHESIS. (PROSTHESIS IMPLANTED ABOUT ONE YEAR AGO AND REMAINED IN PARTIAL ERECT STATE AT ALL TIMES).
ON 2/29 LT RADICAL PNEUMONECTOMY, DRAIN PLACED, SIZE 22. ON 3/1 DRAIN WAS DISCONTINUED BY SURGEON, THE TIP OF DRAIN STAYED IN PT, APPROX. 4CM. CHEST X-RAY DONE, CT OF CHEST, RETURNED TO SURGERY, TIP IN CHEST WALL. TIP REMOVED.
REMOVAL OF CO'S SCREW HARDWARE RIGHT HIP SECONDARY TO SOFT TISSUE INFECTION AT THE BASE OF THE LAG SCREW.
WHEN USING DEVICE TO PERFORM A LAPAROSCOPIC NISSIEN FUNDOPLICATION, THE NEEDLE FELL OUT OF THE INSTRUMENT. WHEN THE SUTURE WAS RETRIEVED, THROUGH THE TROCAR THE NEEDLE WAS MISSING.
REMOVAL OF DEFECTIVE PENILE PROSTHESIS, PROSTHESIS IMPLANTED 3/17/89.
A NONFUNCTIONING PENILE PROSTHESIS WAS REMOVED AND FOUND TO HAVE A HOLE IN THE TUBING.
DURING CATARACT SURGERY ON THE LEFT EYE, USING THE I/A 180 DEGREE TIP ON AN I/A HAND TOOL, AS THE TIP WAS REMOVED, THE IRIS CAME WITH IT. THE IRIS WAS RESUTURED IN PLACE.
PRESSURE RELIEF CONTROL BOX FOR BED WAS VERY WARM AGAINST PT'S FEET. PROBLEM WAS DETECTED BEFORE ANY INJURY TO PT. CO WAS CONTACTED AND CHECKED BOX AND DETERMINED A CONTROL BUTTON HAD BEEN CHANGED. TAPE HELD OVER BUTTON.
ON WEDNESDAY, 4/24/96, AN 82 YR OLD FEMALE PT UNDERWENT CORONARY ARTERY BYPASS SURGERY UTILIZING STANDARD CARDIOPULMONARY BYPASS (CPB) TECHNIQUES AND PHYSIOLOGIC MONITORING. DURING THE COURSE OF CPB, THE ARTERIAL BLOOD PRESSURE (APB) WAS OBSERVED TO APPROACH 100MMHG. UPON ZERO RESET OF THE ABP SYSTEM, THE PRESSURE WAS OBSERVED TO READ 45MMHG. SUBSEQUENT AND FREQUENT ZERO RESET OF THE SYSTEM DEMONSTRATED A SERIOUS ABP ZERO DRIFT PROBLEM. UPON COMPLETION OF THE SURGERY, THE PT WAS PLACED ON INTRA-AORTIC BALLOON PUMP (IABP) THERAPY TO FACILITATE WEANING FROM CPB. AFTER TERMINATION OF CPB, A NORMAL ABP WAS REPORTED BY THE PRIMARY MONIOR BUT WAS OBSERVED TO BE 50MMHG. GREATER THAN THE HYPOTENSIVE ABP REPORTED BY THE IABP MONITOR. AFTER ZERO RESET OF BOTH MONITORS, THE ABP WAS FOUND TO BE HYPOTENSIVE AS REPORTED BY THE IABP MONITOR.
FAILED PENILE PROSTHESIS REMOVED AND REPLACED WITH A NEW PROSTHESIS.
3/32 DRILL BIT BROKE OFF IN RIGHT KNEE (TIBIA). THE SURGEON DID NOT REMOVE DRILL BIT PIECE BECAUSE IT WOULD DISRUPT THE TENDON REPAIR ALREADY COMPLETED AND IS SIMILAR TO PLACING A SCREW IN THE BONE.
DURING REMOVAL OF URETERAL STENT PART OF THE STENT BROKE OFF AND WAS UNABLE TO BE REMOVED THROUGH THE URETEROSCOPE. A URETERAL LITHOTOMY WAS DONE TO REMOVE THE RETAINED PIECE OF STENT.
EMPLOYEE INCORRECTLY PROGRAMMED THE PUMP WHICH UNDERSTATED THE CONCENTRATION OF MEDICINE. THE PT SUBSEQUENTLY RECEIVED 10X THE PRESCRIBED MEDICINE AND WENT INTO RESPIRATORY ARREST. AFTER BEING COMATOSE FOR TWO WEEKS THE PT CEASED.
1/9/95 TOTAL HIP REVISION (RIGHT HIP), 1/11/95 CO'S DRAIN REMOVED, 1/14/95 DISCHARGED IN GOOD CONDITION, 2/6/96 READMITTED - SURGERY FOR REMOVAL OF RETAINED PIECE OF CO'S DRAIN.
BURR ON PADDLE SPOON "NICKED" A PT'S HEART. SMALL AMOUNT OF BLEEDING STOPPED BY SUTURING. TEMPORARY EFFECT ON PT.
MD UNABLE TO TAP IN FEMUR SCREW SO WAS DRILLING SCREW INTO PLACE WHEN TIP BROKE OFF - AT SOLDERED SITE AND LODGED IN BONE. SURGERY (LAPAROSCOPIC) FOR ANTERIOR CRUCIATE LIGAMENT REPAIR (LEFT KNEE).
DURING SURGERY THE ROLLER ELECTRODE SUDDENLY FELL OFF THE INSTRUMENT FREELY INTO THE PT'S BLADDER. PT PASSED THE ELECTRODE WITHOUT INCIDENT.
CATHETER PLACED 5/24/93. CHEST X-RAY SHOWED A FRACTURED CATHETER WITH EMBOLISM OF CATHETER FRAGMENT IN THE RIGHT VENTRICLE. CATHETER FRAGMENT REMOVED UNDER FLUORO USING FEMORAL APPROACH.
DURING FOLLOW-UP FLUOROSCOPY PAST A HIP PINNING FOR AN ANGULATED RIGHT DISTAL RADIUS FRACTURE, IT WAS INCIDENTALLY NOTED THAT TWO SMALL METALLIC FRAGMENTS NEAR THE ENTRY PORTALS IN THE LATERAL FEMORAL CORTEX COULD BE SEEN. IT APPEARS TO BE THE TIP OF THE CANNULATED SCREW. IT MAY HAVE BROKEN AS IT WAS INSERTED INTO THE FEMUR. UNKNOWN WHICH OF THE 3 SCREWS BROKE.
PT HAD A LAPAROSCOPIC PROCEDURE WITH RETROCELE REPAIR. DURING THE PROCEDURE THE LAPROSCOPE GLASS SHATTERED TO PIECES INSIDE THE PT. NO GLASS FOUND.
AUTOCLAVE SET RAN ON WASHER CYCLE. ON EXHAUST-OPENED DOOR; BOILING WATER RAN OUT CAUSING BURN TO EMPLOYEE OPERATOR. EMPLOYEE SEEN AND TREATED IN EMERGENCY DEPARTMENT. DIAGNOSIS: 2ND DEGREE BSA PARTIAL THICKNESS BURNS BOTH FEET.
DURING SURGERY (ATTEMPT TO SAVE PT) O2 PRESSURE DROPPED, COMPONENT OF HEART LUNG MACHINE. DEATH NOT DETERMINED TO BE ATTRIBUTABLE TO DEVICE. PT CODED ON FLOOR, BROUGHT TO SURGERY TO REMOVE EMBOLUS.
DISTAL END OF CATHETER BROKEN OFF IN LEFT PULMONARY ARTERY. SUCCESSFULLY RETRIEVED IN RADIOLOGY.
AN 82-YR-OLD FEMALE ADMITTED ON 12/10/94 WITH A DIAGNOSIS OF ALZHEIMER'S, PSYCHOSIS, AND DEMENTIA. SHE WAS RESTRAINED AT NIGHT IN A WAIST RESTRAINT WITH (4) 1/2 RAILS UP ON THE BED. SHE WAS SEEN AT 9 PM AND AGAIN AT 10:15 PM SLEEPING IN THE BED. SHE WAS FOUND AT 10:50 PM WITH NO PULSE OR RESPIRATION. SHE WAS STILL IN THE RESTRAINT WHICH WAS UNDER HER BREASTS, FULLY OUT OF BED BETWEEN THE UPPER AND LOWER SPLIT RAIL WITH HER JAW RESTING ON THE UPPER RAIL AND HER BUTTOCKS APPROX 1 INCH OFF THE FLOOR. MEDICAL EXAMINER WAS CALLED AND AN AUTOPSY WAS PERFORMED, RESULTS INDICATED DEATH BY ASPHYXIATION. DEPT OF PUBLIC HEALTH WAS NOTIFIED.
PHYSICIAN WAS USING A 10MM TROCAR AFTER INSERTION. IT WAS NOTED THAT THE PLASTIC SHEATH WAS SPLIT BUT INTACT. AFTER THE PROCEDURE WAS COMPLETE AND DURING REMOVAL OF TOCAR, THE PART THAT WAS SPLIT, BROKE OFF. SURGEON HAD TO REMOVE THE PIECES FROM THE PT; ALL PIECES WERE REMOVED.
PT HAD A PORT INSERTED 8/11/95 FOR THE ADMINISTRATION OF CHEMOTHERAPY. ON 10/25/95 THE PORT WAS REMOVED IN THE OR WHEN THE TIP WAS FOUND TO HAVE MIGRATED TO THE INTERNAL JUGULAR. ANOTHER PORT WAS INSERTED ON THE OPPOSITE SIDE AND THE PT DID WELL.
DURING A TRANSURETHRAL RESECTION OF THE PROSTRATE, A 27FR. CONTINUOUS FLOW RESECTOSCOPE LOST ITS WHITE PLASTIC END. PHYSICIAN NOTICED IT FLOATING IN THE BLADDER. PIECE WAS RETRIEVED FROM THE BLADDER. SMALL CHIP NOT FOUND.
PT HAD A PORT INSERTED 7/27/95 FOR THE ADMINISTRATION OF CHEMOTHERAPY. A FLUOROSCOPY DONE IN 12/95, REVEALED THAT A PIECE OF THE CATHETER HAD BROKEN OFF AND HAD MIGRATED INTO THE RIGHT ATRIUM. THE PIECE WAS RETRIEVED BY DOING A FLUOROSCOPY IN THE CARDIAC CATHETERIZATION LAB ON 1/2/96. THE PT DID WELL. IT IS UNKNOWN IF ANOTHER PORT WAS INSERTED. BOTH PORTS WERE NOT RETAINED.
A PT HAD A PROBLEM WITH A PORT. THE PORT WAS INSERTED 6/19/95 FOR CHEMOTHERAPY. ON 4/12/96 THE PORT WAS REMOVED IN THE OR DUE TO EXTRAVASATION AND ANOTHER PORT WAS INSERTED. THE PORT WAS EXAMINED ON 5/13/96 AND FOUND NO EVIDENCE OF LEAKING. FACILITY DID NOT HAVE THE RESULT OF THE CHEST FLUOROSCOPY THAT WAS DONE ON 3/20/96. EXTRAVASATION OF THE DYE WAS NOTED AT THE MID SEGMENT OF THE CATHETER.
PHYSICIAN ATTEMPTED TO USE A CANAL CUTTING INTUBATION SET; ALL DEVICES IN INVENTORY WERE DEFECTIVE (1 BOX). PROCEDURE WAS STOPPED.
PT HAD A PORT INSERTED 7/27/95 FOR THE ADMINISTRATION OF CHEMOTHERAPY. A FLUOROSCOPY DONE IN 12/95, REVEALED THAT A PIECE OF THE CATHETER HAD BROKEN OFF AND HAD MIGRATED INTO THE RIGHT ATRIUM. THE PIECE WAS RETRIEVED BY DOING A FLUOROSCOPY IN THE CARDIAC CATHETERIZATION LAB ON 1/2/96. THE PT DID WELL. IT IS UNKNOWN IF ANOTHER PORT WAS INSERTED.
SURGEON ATTEMPTED ACL LEFT KNEE. WHEN SURGEON ACTIVATED HANDSWITCH FOR COAG, HE GOT CUT INSTEAD. PHYSICIAN CONNECTED TISSUE AND CONTINUED THE PROCEDURE WITH HAND PENCIL BUT USING THE BUTTONS BACKWARDS; NO PERMANENT DAMAGE TO PT. A SECOND PENCIL FROM THE SAME LOT WAS TRIED IN ANOTHER CASE WITH SIMILAR RESULTS. BIOMEDICAL ENGINEERING TESTED THESE UNITS AND CONFIRMED THAT THEY WERE WIRED BACKWARDS. TWO OTHERS FROM THE SAME LOT SHOWED NO PROBLEM.
A 70-YR-OLD FEMALE ADMITTED FOR INSERTION OF PACEMAKER DUE TO COMPLAINTS OF DIZZINESS AND FAINTING SPELLS. PROCEDURE PERFORMED, AT CLOSE OF PROCEDURE (WHILE STILL IN OR) PT COMPLAINED OF CHEST DISCOMFORT. PT LOST CONSCIOUSNESS, UNABLE TO OBTAIN PULSE. CODE CALLED, UNABLE TO RESUSCITATE. PT EXPIRED. AUTOPSY PERFORMED, RESULTS NOT AVAILABLE AS OF 3/27/96.
CO'S DEVICE RESERVOIR NOT PATENT, CHANGED, BULB FOUND TO BE DEFECTIVE.
THE PRESCRIPTION FOR THE PT WAS 300C GY/FX GIVEN DOSE FOR 15 FRACTIONS WIT 6 MCV ELECTRONS TO AN AREA OF HIS RIGHT EAR. THE TREATMENT FIELD WAS SET UP USING THE 5CM DIAMETER PLASTIC TIP CONE. ACCELERATOR MONITOR UNITS NEEDED TO DELIVER THE PRESCRIBED DOSE WERE CALCULATED USING OUTPUT FACTORS FOR THE 5CM DIAMETER METAL CONE. THIS RESULTED IN THE PT RECEIVING 7 TREATMENTS OF 414C GY GIVEN DOSE (2898C GY/7FX). ONCE THIS ERROR WAS DISCOVERED THE PRESCRIPTION WAS AMENDED BY THE PHYSICIAN TO DECREASE THE DOSE RATE TO 200 C GY PER FRACTION FOR THE REMAINING 8 TREATMENTS. AT COMPLETION OF THIS COURSE OF TREATMENT, THE PT WILL HAVE RECEIVED 4500 C GY GIVEN DOSE IN 15 FRACTIONS.
WHILE PERFORMING A CORONARY ARTERY STENT PROCEDURE, THE STENT WAS PASSED THROUGH THE GUIDE. THE GUIDE "FLIPPED" STENT CAME OFF. GUIDE AND BALLOON REMOVED, UNABLE TO VISUALIZE THE STENT.
AFTER INJECTION OF IV CONTRAST MEDIA, PT EXPERIENCED RESPIRATORY ARREST. PT EXPIRED 6/18/96. CONTRAST MEDIA WAS INJECTED FOR A CT SCAN.
CONTRAST MEDIA INJECTED INTO LEFT ARM DURING CT SCAN. PT COMPLAINED OF LEFT ARM PAIN AFTER INJECTION. EXTRAVASATION OF INTRAVENOUS CONTRAST OCCURRED.
RED BURN MARK AROUND LEFT TROCAR SKIN OPENING IN THE ABDOMEN. BURNT SKIN EXCISED BY THE SURGEON. REP WAS PRESENT FOR THIS EVENT.
CONTRAST MEDIA INJECTED DURING CT SCAN. PT COMPLAINED OF PAIN AT IV INSERTION SITE. INJECTION STOPPED IMMEDIATELY. EXTRAVASATION OF INTRAVENOUS CONTRAST OCCURRED.
FAILED RIGHT TOTAL KNEE REPLACEMENT ARTHROPLASTY. PLASTIC ON DEVICE FAILED AND DEVICE LOOSENED.
CUP LINER WORE THIN; PROSTHESIS WAS REPLACED. REPLACED EQUIPMENT: 46 MM OPTIFIX TITANIUM CO'S ACETABULAR SHELL. 28 MM INNER DIAMETER LINER, CO'S CEMENTLESS TITANIUM FEMORAL COMPONENT.
NO URINE DRAINAGE FROM FOLEY. COULD NOT DEFLATE BALLOON. MD CALLED; USED SPINAL NEEDLE TO DEFLATE BALLOON.
PT CAME TO CR WITH TIBIAL PAIN. X-RAYS WERE TAKEN APPEARED BASEPLATE COULD BE LOOSE, BASEPLATE WAS REMOVED AND REPLACED.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
DR SUSPECTED THAT THE TIBIAL INSERT HAD WORN AND FOUND THAT TO BE THE CASE AT THE TIME OF SURGERY. HE REPLACED THE INSERT WITH A NEW ONE.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
FEMALE CLIENT RENTED WHEELCHAIR. REPORTEDLY, WHEN CROSSING THE STREET, THE FRONT TIRE ON THE WHEELCHAIR BROKE CAUSING CLIENT TO FALL OUT AND FRACTURE HER ARM. UNKNOWN IF MEDICAL TREATMENT WAS REQUIRED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
CO RECEIVED INFO THAT THIS PT WAS RECEIVING SHOCKS FROM HIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT DID NOT SEEM TO BE APPROPRIATE. FURTHER INVASIVE TESTING FOUND THAT ONE OF THE PT'S SUTURELESS MYOCARDIAL RATE-SENSING LEADS HAD AN INSULATION BREAK, WHICH WAS CAUSING OVERSENSING AND MOST LIKELY CAUSING THE INAPPROPRIATE SHOCKS. THE INSULATION WAS REPAIRED, AND FURTHER TESTING FOUND THAT THE LEAD WAS PERFORMING NORMALLY. THE LEAD REMAINS IMPLANTED. IT IS UNKNOWN WHICH OF THE TWO LEADS EXHIBITED THE INSULATION BREAK; ONE SERIAL NUMBER WAS SELECTED FOR REPORTING PURPOSES. THE ICD WAS REPLACED ELECTIVELY AT THE SAME TIME BECAUSE IT WAS APPROACHING NORMAL BATTERY DEPLETION. IMPLANT DATE 5/20/93, IMPLANT TIME: 37 MONTHS.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
NURSE WAS ADJUSTING PEDAL ON WHEELCHAIR WHEN PEDAL FELL DOWN PINCHING NURSE'S FINGER. NURSE WENT TO ER FOR X-RAYS. X-RAYS WERE NEGATIVE. NO OTHER MEDICAL TREATMENT WAS REQUIRED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN INFO REGARDING THIS INCIDENT TO NO AVAIL. REPORTEDLY, THE SPRING LOADED LATCH BROKE CAUSING THE LEGREST TO FALL AND POSSIBLY FRACTURE THE HEEL OF THE PT. REPORTEDLY, X-RAYS WERE TAKEN. UNKNOWN IF FURTHER MEDICAL TREATMENT WAS NECESSARY.DEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD.  INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT.  METHOD OF EVALUATION:  INVALID DATA.  RESULTS OF EVALUATION:  INVALID DATA.  CONCLUSION:  INVALID DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
A 8.0 MM TRACHEOSTOMY TUBE INSERTED 2/18/95. ON 2/27/96, WHILE PT BEING SUCTIONED AT HOME, CANNULA BROKE OFF AT THE FLANGE. CANNULA ASPIRATED. PT TRANSPORTED TO HOSP, WHERE CANNULA WAS REMOVED WITH EMERGENT BRONCHOSCOPY. PT ADMITTED TO HOSP FOR OBSERVATION, RELEASED HOME NEXT DAY.
AFTER ABDOMINAL-PERINEAL RESECTION WITH VAGINECTOMY, ELECTROSURGICAL UNIT PT RETURN PLATE WAS REMOVED. RN NOTED DARK, RED-PURPLE SQUARE SHAPED AREA, VISIBLE ON PT'S LEFT UPPER THIGH. PHYSICIAN THOUGHT IT WAS A BURN. ALL PRODUCTS WITH THIS SERIAL NUMBER PULLED FROM SVC. CO REP NOTIFIED. A FOLLOW-UP WITH THE PHYSICIAN WAS DONE 6/7/96. THE PT WAS TREATED WITH A TOPICAL OINTMENT. UNIT CHECKED OUT BY BIOMED ENGINEER AND FOUND TO BE WITHIN SPECS.
PURCHASED THE DEVICE ON JULY 20, 1996. THEY PRACTISED WITH THE BACTERIOSTATIC SODIUM CHLORIDE PROVIDED. HE HAD WET AND PARTIAL INJECTIONS WITH THE SODIUM CHLORIDE. THEY PROCEEDED TO USE THE DEVICE WITH INSULIN. THEY DID MAKE ADJUSTMENTS TO COMFORT SETTINGS AS ADVISED, BUT WERE UNABLE TO FIND A SETTING THAT GAVE HIM GOOD INJECTIONS. HIS BLOOD GLUCOSE LEVELS ELEVATED AND HE COMPLAINED OF BACK PAIN AND WAS BROUGHT TO THE HOSP ON 7/29. HE WAS ADMITTED TO THE HOSP ON THE FOR 450 BLOOD GLUCOSE LEVELS AND KETONES IN HIS URINE. HE IS CURRENTLY USING SYRINGES AND HAS RETURNED THE DEVICE TO THE STORE FOR A REFUND.
1. IS THE EVENT FREQUENCY ADDRSSED ON PRODUCT LABELLING? NO. 2. A. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED ON LABELLING? NO. 2. B. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR THE PRODUCT? NO. IS EVENT SEVERITY ADDRESSED ON PRODUCT LABELLING? NO. B. IF NO, IS EVENT OF GREATER SEVERITY THAN USUAL FOR THE PRODUCT? YES.
PT WAS HAVING PULSED DYE LASER LITHOTRIPSY OF URETERAL CALCULUS. AN APPROX 1/2 INCH PIECE OF LASER FIBER BROKE OFF IN PT'S URETER DURING PROCEDURE. THE PIECE WAS REMOVED WITH A STONE BASKET. PRIOR USES: 5/1/96 PULSES 62, 5/15/96 PULSES 784, 5/28/96 PULSES 369, 5/30/96 PULSES 979. ON 6/12, 744 PULSES.
CO2 ACTIVATED STAPLER GUN FAILED TO EJECT AND STAPLE ON ROUNDS 34-4 OF 4 STAPLES. THIS OCCURRED REPEATEDLY WITH TWO DIFFERENT LOT NUMBERS. AS A CONSEQUENCE, SURGERY WAS DELAYED UP TO AN HR AND MANUAL STAPLES WERE NEEDED TO COMPLETE THE PROCEDURE WITH THE LUNG. AS THE EQUIPMENT "PINCHED" WITHOUT "STAPLING" SOME FRIABLE LUNG TISSUE WAS TORN.
A 49-YR-OLD FEMALE UNDERWENT A TOTAL KNEE REPLACEMENT ON 2/5/96 UNDER REGIONAL ANESTHESIA. THE PT'S BLOOD PRESSURE WAS BEING MONITORED BY CO'S MODULE DURING THE PROCEDURE. CUFF INFLATIONS WERE INTERMITTENT. THE PT WAS AWAKE DURING THE ENTIRE TWO HR PROCEDURE. POST OPERATIVELY, THE PT COMPLAINED OF NUMBNESS IN HER RIGHT ARM. THE COMPLAINT IS FIRST DOCUMENTED 48 HRS POST-OP. THE NEUROPATHY IS NOT KNOWN TO HAVE BEEN CAUSED BY COMPRESSION FROM THE CUFF, HOWEVER, NO OTHER ETIOLOGY HAS BEEN IDENTIFIED. NO PROBLEMS WITH THE MACHINE WERE NOTED DURING THE PROCEDURE. AN ELECTROMYOGRAPHY STUDY WAS PERFORMED ON 4/26/96 INDICATED THAT THE PT HAD AN ULNAR NEUROPATHY.
WHEN SETTING UP AN ARTERIAL LINE, LUER LOCK DEVICE CAME APART FROM THE TUBING. THE LINE WAS NOT CONNECTED TO THE PT. THIS EVENT OCCURRED IN THE NEUROSURGERY INTENSIVE CARE UNIT ON 6/17/96. ON 6/18/96 IN THE MEDICINE INTENSIVE CARE UNIT, THE PT HAD THIS PRODUCT CONNECTED TO HIS ARTERIAL LINE. THE NURSE NOTICED THAT BLOOD WAS COMING FROM THE TUBING. FURTHER EXAMINATION BY THE NURSE, REVEALED THAT THE LUER LOCK DEVICE HAD COME APART FROM THE TUBING. THE NURSE CLAMPED THE LINE AND CEASED THE BLEEDING. THE PT LOST APPROX 50-100 CC OF BLOOD. NO PT INJURY OCCURRED, HOWEVER, THE PT'S BLOOD LOSS COULD HAVE POTENTIALLY BEEN MORE IF THE NURSE HAD NOT INTERVENED. BOTH DEVICES CAME FROM THE SAME LOT NUMBER.
LAPAROSCOPIC APPENDECTOMY. PIECE OF INSTRUMENT BROKE OFF DURING USE, DISCOVERED THROUGH CAMERA. BROKEN PIECE RETRIEVED, A SECOND INSTRUMENT WAS USED TO FINISH THE CASE. A COMPLETE CHECK OF THE ABDOMINAL CAVITY WAS DONE.
WHILE DOING A DIAGNOSTIC L/S, THE BALLOON ON THE END OF THE DEVICE BURST INSIDE THE PT AND THE OVARY FELL BACK INTO THE PT. A SECOND DEVICE WAS USED TO RETRIEVE THE OVARY.
WHILE DOING AN ENDOSCOPIC HERNIOPLASTY THE THREADED GRIPPER BROKE WHILE BEING USED ON THE PT. DATE REMOVED: 4/10/96.
DIFFICULTY EXPERIENCED REMOVING PERCUTANEOUS CATHETER DUE TO THE ADHERENCE OF CATHETER TO THE VESSEL WALL. CATHETER WAS REMOVED USING BEDSIDE CUT DOWN PROCEDURE.
WILL EVALUATE PRODUCT IF RETURNED. WILL BE DISCUSSING THIS WITH RISK MANAGER. THERE ARE SEVERAL CLINICAL CAUSES OF THIS PROBLEM AND STEPS CAN BE TAKEN TO ALLEVIATE THIS WITHOUT SURGICAL OR CUT DOWN INTERVENTION. THIS WILL ALL BE HIGHLIGHTED IN FOLLOW-UP REPORT TO THE FACILITY, NEXT WEEK.
WHILE DOING A DIAGNOSTIC LAPAROSCOPY, WHEN THE GRASPER WAS TAKEN OUT. THE BLACK PIECE WAS MISSING AND IT COULD NOT BE FOUND.
DURING ENDOSCOPIC CHOLECYSTECTOMY ONE JAW OF SCISSORS BROKE OFF. RETRIEVED DURING SURGERY.
SURGEON PULLING ON TROCAR SHEATH FROM PT'S PELVIS AND IT CAME OUT IN PIECES. PT WAS X-RAYED AND PELVIS WAS SEARCHED FOR BROKEN PIECES.
PHYSICIANS REPORT RECEIVED ALLEGING TSS.
510K #905928 1 PERSON SERIOUS INJURY TYPE G.
WHEN SURGEON ATTEMPTED TO INFLATE CATHETER IT POPPED, REQUIRING REMOVAL AND REPLACEMENT.
RIGHT BREAST IMPLANT LEAKED INTO TISSUE AND REQUIRED SURGICAL REMOVAL.
FEMORAL NAIL FRACTURED, EXPLANTED 5 MOS AFTER IMPLANTATION, REQUIRED NEW NAIL.
DURING ATTEMPT TO UNBLOCK A BLOCKED TUBE, THE DISTAL END OF THE TUBE FRACTURED, LEAVING THE END IN THE PT'S BODY.
52 YR OLD PT HAD PRE-MALIGNANT MASTOPATHY REQUIRING PROPHYLACTIC MASTECTOMY IN 1988. THIS WAS DONE ON BOTH THE LEFT AND RIGHT SIDES. SHE EXTRUDED HER RIGHT BREAST IMPLANT SECONDARY TO INFECTION AND HAD HAD SOME ADD'L SKIN LOSS. THIS REQUIRED A TRANSVERSE RECTUS ABDOMINIS MYOCUTANEOUS FLAP RECONSTRUCTION. HER LEFT SIDE WAS RECONSTRUCTED WITH CO IMPLANT. OVER THE PAST SEVERAL YEARS HAS HAD PROGRESSIVE FIBROMYALGIA TYPE SYMPTOMS, CHRONIC FATIGUE, AND OTHER RELATED IMMUNE TYPE DISORDERS, HOWEVER, SEROLOGY WAS NEGATIVE. SHE WAS REFERRED BY HER INTERNIST FOR CONSIDERATION FOR REMOVAL OF HER RESIDUAL IMPLANT TO SEE IF IT WOULD HELP HER SYMPTOMS. ON 11/7/95 SHE UNDERWENT OPEN CAPSULECTOMY AND EXPLANTATION OF LEFT BREAST IMPLANT AND LEFT BREAST RECONSTRUCTION.
SNARE BROKE OFF DURING ATTEMPT TO SNARE TONSIL.
A 44 YR OLD FEMALE WITH BILATERAL SUBGLANDULAR SILICONE BREAST IMPLANTS FOR 10 YRS NOTICED OVER THE PAST FEW YEARS PALPABLE BREAST MASSES, TWO BEING IN THE LEFT BREAST AND ONE MASS BEING IN HER RIGHT BREAST. IN ADDITION, SHE PRESENTED WITH BILATERAL CAPSULAR CONTRACTURES AND A MAMMOGRAM SHOWING QUESTION OF A RUPTURE OF THE LEFT BREAST IMPLANT. ON 11/9/95 THE PT UNDERWENT REMOVAL AND CAPSULECTOMIES WITH REPLACEMENT OF THE IMPLANTS.
PT SCHEDULED FOR IN-PATIENT COLONOSCOPY. WHILE PROCEDURE WAS BEING PERFORMED, THE PHYSICIAN ENCOUNTERED DIFFICULTY WITH USING CAUTERY. SNARE WAS USED TO REMOVE POLYP AND AGAIN NO CAUTERY WAS AVAILABLE AT SETTING 3/3 BLEND CURRENT. FOLLOWING THE PROCEDURE, THE PT UNDERWENT EMERGENCY SURGERY DUE TO A PERFORATED CECUM. PT HAD POST-OP COMPLICATIONS AND HAD APPROX ONE MONTH HOSPITALIZATION.
A 65-YR-OLD FEMALE STATUS POST PLACEMENT OF SILICONE GEL IMPLANTS IN 1976. THE PT IS UNSURE OF TYPE OF IMPLANTS OTHER THAN THAT THEY ARE SILICONE, BUT FEELS THEY MAY BE THIS MFR'S (PREVIOUS RECORDS ARE UNAVAILABLE). PREOPERATIVE EXAM SHOWED EVIDENCE OF BILATERAL CAPSULAR CONTRACTURE. MAMMOGRAMS SHOWED NO EVIDENCE OF MASSES OF THE BREAST TISSUE. ON 12/1/95 PT UNDERWENT BILATERAL REMOVAL OF RUPTURED IMPLANTS AND BILATERAL CAPSULECTOMIES.
DURING CATARACT SURGERY, THE PHYSICIAN WAS USING MEDICAL DEVICE AS WELL AS ANOTHER INSTRUMENT TO MANIPULATE THE LENS. THE TWO INSTRUMENTS CAME IN CONTACT WITH EACH OTHER ON SEVERAL OCCASIONS AND THE PHACO TIP WAS DAMAGED WITH SEVERAL FRAGMENTS LODGED IN THE PT'S EYE.
AFTER INSERTION OF TROCAR INTO PT FOR PLACEMENT OF CATHETER, THE CATHETER WAS REMOVED AND THE DISTAL TIP NOTED TO BE CRACKED. THE PHYSICIAN WAS INFORMED AND THE CATHETER WAS REPLACED. THE CATHETER TIP WAS INTACT AND NO ADD'L PROCEDURES WERE NEEDED.
TWENTY-TWO-YR-OLD WHITE FEMALE PRESENTED TO THE HOSP ON 3/7/96 IN EARLY LABOR AT APPROX 37 WEEKS GESTATION. SHE UNDERWENT EMERGENCY CESAREAN SECTION DUE TO PROLAPSED CORD. POST-OPERATIVELY ON THE NIGHT OF ADMISSION, THE PT FELT A "POP". FOLEY CATHETER EXAMINED AND REMOVED WITH LATEX BULB MISSING FROM CATHETER TIP. UROLOGY CONSULT OBTAINED AND CYSTOSCOPY PERFORMED, HOWEVER, NO EVIDENCE OF FOREIGN BODY FOUND ON EXAMINATION.
PT IS A 53 YR OLD WHITE FEMALE WHO WAS APPROX. 3 WEEKS STATUS POST BILATERAL IMPLANT REMOVAL AND REPLACEMENT WITH GEL 225 CC IMPLANTS. APPROX. 10 DAYS PRIOR, PT DEVELOPED SOME DRAINAGE FROM THE RIGHT INFRAMAMMARY INCISION. THIS WAS TREATED WITH IV ANTIBIOTICS AND WOUND CLOSURE. SHE DEVELOPED RECURRENT DRAINAGE EVEN THOUGH THERE WAS NO EVIDENCE OF OPEN WOUND ON EXAM AND PREVIOUS CULTURES SHOWED NO GROWTH. SHE WAS TAKEN TO OR ON 12/18/95 FOR REMOVAL OF THE RIGHT BREAST IMPLANT WITH DEBRIDEMENT OF RIGHT BREAST AND PLACEMENT OF DRAIN. BECAUSE THE ENTIRE CAPSULE APPEARED TO BE INFLAMED AND THICKENED AND BOGGY AND BECAUSE OF WORRIES OF ONGOING PROBLEMS WITH POSSIBLE IMPLANT INFECTION, THE IMPLANT WAS FELT NECESSARY TO BE LEFT OUT.
PT IS A 41 YR OLD WHITE FEMALE WHO IS STATUS POST BILATERAL BREAST AUGMENTATIONS (IN A SUBGLANDULAR POSITION) WITH GEL IMPLANTS IN THE LATE 1980'S. SHE PRESENTED WITH SYMPTOMATIC CAPSULAR CONTRACTURE IN BOTH BREASTS AND SIGNIFICANT BREAST PTOSIS. ON 12/21/95 SHE UNDERWENT BILATERAL TOTAL CAPSULECTOMIES AND REMOVAL OF GEL 320 CC IMPLANTS.
THE RESIDENT IN QUESTION IS A SMALL MAN WITH A DIAGNOSIS OF DEMENTIA AND CVA. THIS INCIDENT OCCURRED WHILE HE WAS IN BED. HE HAD BEEN CHECKED BY THE NURSE AT 2:00 AM AND WAS IN THE CENTER OF THE BED. AT 2:35 AM HE WAS FOUND LODGED BETWEEN THE BED RAIL AND THE BED FRAME. HE HAD TURNED AND SCOOTED HIMSELF AND PUSHED UNTIL ABOUT HALF OF HIS BODY WAS BETWEEN THE BED RAIL AND BED FRAME. WHEN HE WAS FOUND HE WAS UNRESPONSIVE, COLD AND MOTTLED SOME. HE WAS MANUALLY REMOVED, OXYGEN WAS STARTED AND HE DID RESPOND QUICKLY. HE SEEMS TO BE FINE.
THIS 72 YR OLD RETIRED MALE ORIGINALLY HAD INSERTION OF A PERMANENT TRANSVENOUS PACEMAKER ON 4/2/81 FOR SINUS NODE DYSFUNCTION WITH SA REST UP TO 6.5 SEC., ASSOCIATED WITH SYNCOPE. HE HAD REPLACEMENT OF HIS PULSE GENERATOR BECAUSE OF IMPENDING BATTERY DEPLETION ON 5/17/88. PULSE GENERATOR WAS PLACED WITH CO'S IN LINE BIPOLAR PULSE GENERATOR. HE HAS HAD HIS PACEMAKER MONITORED WITH HIS CARDIOLOGIST WITH TRANSTELEPHONIC MONITORING AND IN OFFICE PACING SYSTEM ANALYSIS. ON 3/16/91, CO SENT OUT AN "URGENT MEDICAL DEVICE SAFETY ALERT" LETTER, STATING THAT THERE WAS A POSSIBILTY OF SUDDEN LOSS OF OUTPUT IN HIS MODEL PULSE GENERATOR. THE PT WAS INFORMED OF THE LETTER AND AFTER DISCUSSION WITH CO'S ENGINEERS, IT WAS ELECTED TO CONTINUE TO FOLLOW HIS PULSE GENERATOR. ON 12/18/95, A TRANSTELEPHONIC MONITORING REVEALED A MAGNET RATE OF 74.6 BEATS PER MINUTE WITH RECOMMENDED REPLACEMENT TIME AT 80.3 BPM. THE FOLLOWING DAY, THE COREP EVALUATED THE PACEMAKER AND MAGNET RATE WAS FOUND TO BE 58 BPM. IT WAS BELIEVED THE PULSE GENERATOR WAS ACTUALLY FAILING AND IT WAS RECOMMENDED THAT IT BE REPLACED AS SOON AS POSSIBLE. ON 12/20/95, THE PT UNDERWENT REPLACEMENT OF DEVICE WITH CO'S IN LINE BIPOLAR MULTI-PROGRAMMABLE VVIR PULSE GENERATOR.
ARTERIAL LINE TUBING BECAME LOOSENED AND GRADUALLY DISCONNECTED WHEN PT'S LEGS WERE LOWERED AFTER THE PREP. THE ARMS WERE TUCKED BY THE SIDES AND COVERED WITH STERILE DRAPES SO THE ARTERIAL SITE WAS NOT VISIBLE. EBL 500 CC.
THIS 65 YR OLD WAS DIAGNOSED WITH LUNG CANCER IN 5/95. A CENTRAL LINE WAS PLACED ON 9/22/95 FOR CHEMOTHERAPY IN THE LEFT SUBCLAVIAN. ON 1/11/96, THE  CATHETER WAS REMOVED UNDER LOCAL SEDATION AND REPLACED WITH THE SAME BRAND CATHETER. THIS WAS DONE BECAUSE THE PORT WAS NOT FUNCTIONAL. AFTER THE PORT WAS REMOVED, THE LINE WAS FLUSHED AND NOTED TO HAVE A VERY SMALL PIN HOLE LEAK.
THIS IS AN 84 YR OLD MALE PT WHO HAD A PRIOR PACEMAKER IMPLANTED FOLLOWING AORTIC VALVE REPLACEMENT BECAUSE OF HEART BLOCK. HE WAS FOLLOWED BY HIS CARDIOLOGIST AND HAS BEEN DOCUMENTED TO HAVE PACEMAKER MEDIATED TACHYCARDIA. ON 2/19/96, HE WAS SEEN IN DAY SURGERY TO HAVE THE PULSE GENERATOR CHANGED UNDER GENERAL ANESTHESIA. THE OLD PULSE GENERATOR WAS REMOVED. THE ATRIAL AND VENTRICULAR LEADS WERE NORMAL AND CONNECTED TO A CO'S PACEMAKER.
PT OBSERVED TO BE CYANOTIC, BRADYCARDIC AND UNRESPONSIVE. PT WAS REMOVED FROM VENTILATOR AND WAS UNABLE TO BE VENTILATED WITH AMBU BAG. THE INNER CANNULA IN TRACH TUBE WAS NOTED TO BE KINKED. INNER CANNULA WAS UNKINKED, SECURED AND PT BAGGED ON 100% O2. PT PLACED BACK ON MECHANICAL VENTILATION. PT SUFFERED NO UNTOWARD EFFECTS.
THIS 53 YR OLD FEMALE HAD INSERTION OF A PERMANENT PULSE GENERATOR ON 7/23/90, FOR PROFOUND SINUS BRADYCARDIA WITH VENTRICULAR PREMATURE BEATS AND BIGEMINY ASSOCIATED WITH SYMPTOMS OF NEAR-SYNCOPE WTH EPISODES OF PROFOUND FATIGUE. SHE HAS MODEST EXIT BLOCK ON BOTH THE ATRIAL AND VENTRICULAR LEADS WHICH PERSISTED THROUGHOUT HER FOLLOW-UP. SHE WAS FOLLOWED AT REGULAR INTERVALS WITH TRANSTELEPHONIC MONITORING AND IN-OFFICE PACING SYSTEM ANALYSIS. TRANS-TELEPHONIC MONITORING ON 12/22/95, REVEALED PACING AT 70 BEATS/MINUTE, AND A MAGNET RATE OF 80 BEATS/MINUTE, WHICH IS THE END OF THE SERVICE INDICATOR OF THE PULSE GENERATOR. ON 12/28/95, UNDER LOCAL ANESTHESIA, THIS PULSE GENERATOR WAS REPLACED BECAUSE OF IMPENDING BATTERY DEPLETION, WITH ANOTHER PULSE GENERATOR. THE CO'S BIPOLAR ATRIAL AND VENTRICULAR LEADS ALREADY IN PLACE WERE RE-UTILIZED.
UPON REMOVAL OF CATHETER FROM ARTERY TIP OF CATHETER WAS NOTED TO BE MISSING. SURGEON AWARE. X-RAYS WERE TAKEN AND WERE NEGATIVE FOR FOREIGN BODY. PT TOLERATED SURGICAL PROCEDURE WELL. PT DOING WELL POST-OPERATIVELY.
PHYSICIAN NOTED LARGE AMOUNTS OF LINT ON HER GLOVES AND IN THE PT'S WOUND AFTER USING THE LAP SPONGE INTRA-OP. INCIDENT NECESSITATED WOUND IRRIGATIONS AND SOME CONCERNS THAT THE PT COULD RETURN WITH INFECTION OR STERILE ABSCESS. TO DATE, HOWEVER, NO UNTOWARD EVENTS HAVE OCCURRED.
SHREDDING THREADS IN WOUND AT SURGERY, REQUIRED IRRIGATION TO REMOVE. NO PT PROBLEMS AT THIS TIME, HOWEVER, THIS RAISES THE CONCERN OF POSSIBLE SURGICAL INFECTION RESULTING.
PT WAS POST CORONARY ARTERY BYPASS GRAFTING AND HAD SIGNIFICANT VENTRICULAR TACHYCARDIA AND WAS TREATED WITH AN AICD SEVERAL YEARS AGO. ON 6/3/96 PT HAD A SHOCK FROM ICD FOR NSR. THEN COMPLAINED OF MULTIPLE SHOCKS. ON 6/4/96 TO OR FOR INSERTION OF NEW DEFIBRILLATOR SENSING LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR GENERATOR CHANGE AS WELL AS TESTING OF DEFIBRILLATOR LEAD AND SVC. DURING PROCEDURE THE DEFIBRILLATOR GENERATOR POCKET WAS OPENED AND THE RATE SENSING LEAD AT THE JUNCTION OF THE INSERTION INTO THE DEFIBRILLATOR GENERATOR WAS FOUND TO HAVE THE INSULATION STRIPPED AND PULLED BACK WITH THE SENSING LEAD COIL EXPOSED - A NEW LEAD WAS PLACED AND THE GENERATOR THAT HAD BEEN USED FOR THE PAST FEW YEARS WAS ALSO REPLACED. THE PT TOLERATED THE PROCEDURE WELL. 6/6/96 EQUIPMENT TO CO REP. CO'S GENERATOR.
THIS 42 YR OLD FEMALE, IS APPROX. 15 YRS POST AUGMENTATION MAMMOPLASTY WITH SUBGLANDULAR SILICONE GEL IMPANTS. SHE HAD NOTICED A CHANGE IN THE IMPLANTS AND ON RADIOGRAPHIC STUDIES, FINDINGS WERE SUSPICIOUS FOR INTRA AND EXTRACAPSULAR FAILURE OF THE RIGHT IMPLANT AND POSSIBLE INTRACAPSULAR FAILURE OF THE LEFT IMPLANT. ON 3/28/96, PT UNDERWENT TOTAL CAPSULECTOMY AND REMOVAL OF SILICONE GEL IMPLANT MATERIAL OF THE RIGHT BREAST AND TOTAL CAPSULECTOMY AND REMOVAL OF SILICONE GEL IMPLANT MATERIAL OF THE RIGHT BREAST AND TOTAL CAPSULECTOMY AND REMOVAL OF SILICONE GEL IMPLANT OF THE LEFT BREAST. PT WAS FOUND TO HAVE BILATERAL CAPSULAR CONTRACTURE, GRADE II/III.
HEAD OF BED RAISED AUTOMATICALLY WHEN BED WAS PLUGGED INTO ELECTRICAL WALL OUTLET WITHOUT PUSHING ANY CONTROL BUTTONS. CONTROL BUTTONS DID NOT WORK TO LOWER BED POSITION. BED IS WITHOUT MANUAL CONTROLS. PT WAS BEING ADMITTED TO INTENSIVE CARE UNIT TO BE PLACED IN CERVICAL TRACTION.
THIS IS A 58 YR OLD WHITE FEMALE WHO FIRST PRESENTED IN 1/93 WITH OVARIAN CANCER. THIS WAS TREATED SUCCESSFULLY. HOWEVER ON 11/94, SHE PRESENTED WITH BREAST CANCER. THIS WAS TREATED WITH LUMPECTOMY, LYMPH NODES DISSECTION AND POST OPERATIVE RADIATION THERAPY. SHE DID WELL, BUT HER OVARIAN CANCER RECURRED. ON 8/30/95 A PORT WAS PLACED. RECENTLY SHE HAD EPISODES OF FEVER, CHILLS AND WAS ADMITTED TO THE HOSP FOR IV ANTIBIOTICS. IT HAS NOW BECOME APPARENT THAT THE PORT MAY BE INFECTED. IN ADDITION, A VENOGRAM WAS OBTAINED THROUGH THE PORT, AND IT APPEARS TO BE LEAKING. ON 3/29/96, THE PT WAS TAKEN TO THE OPERATING ROOM FOR THE REMOVAL OF THE RIGHT SUBCLAVIAN VEIN PORT. SHE TOLERATED THE PROCEDURE WELL.
DURING BRONCHOSCOPY, LASER TREATMENT OF TUMOR ATTEMPTED. FIRE ERRUPTED IN AIRWAY AFTER INITIAL FIRING OF LASER.
JOINT IMPLANT LOOSENED CAUSING PT CONSIDERABLE PAIN IN THE LEFT FIRST TOE.
DURING OPHTHALMIC PROCEDURE, SURGICAL DRAPE IGNITED DURING USE OF CAUTERY. PT'S EYEBROW AND EYELASHES WERE SINGED AND MINOR SKIN BURN RESULTED.
THE PT SAT IN THE COMMODE AND THE COMMODE COLLAPSED. THE RIGHT LEG BENT INWARD. THE PT DID NOT FALL, HUSBAND CAUGHT PT BEFORE SHE HIT THE FLOOR.
PT REQUIRED REMOVAL OF DEVICE DUE TO INFECTION. CULTURE OF SITE SHOWED NO GROWTH. HOWEVER THE SITE WAS DESCRIBED AS "PORT PURULENCE" BY THE PHYSICIAN.
TWO CURRETTE TIPS BROKE OFF IN SKULL. ONE RETURNED, ONE FOUND AFTER CLOSED SKIN AND X-RAY PERFORMED. PIECE FOUND AND REMOVED.
PT REQUIRED REMOVAL OF CATHETER DUE TO DEVELOPMENT OF SEPSIS CAUSED BY METHICILLIN-RESISTANT STAPH. AUREUS. PT HAD RECEIVED A COURSE OF ANTIBIOTIC THERAPY OF VANCOMYCIN AND GENTAMYCIN PRIOR TO REMOVAL. CULTURES CONTINUED TO BE POSITIVE FOR MRSA.
PT REQUIRED REMOVAL OF CATHETER DUE TO INFECTION CAUSED BY STAPH AUREUS WHICH WAS FELT TO HAVE ENTERED THE BLOOD STREAM THROUGH THE PORT.
PT REQUIRED REMOVAL OF CATHETER AFTER DEVELOPING SEPSIS CAUSED BY STAPH AUREUS. IT WAS FELT THE INFECTION WAS ACQUIRED THROUGH THE PORT.
WHILE WALKING IN HIS HOME WITH WALKER, USER LOST HIS BALANCE, TRIPPED AND HIT HIS HEAD ON THE WALKER. USER REQUIRED 7 STITCHES.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT THAT IS USUAL? U.  IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N.  IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
PROXIMAL PORT OF CATHETER FOUND IN BED OF PT. BLUE PORT WAS PULLED AWAY FROM REST OF CATHETER. BLOOD WAS LEAKING FROM CATHETER WHERE PORT WAS PULLED AWAY.
PT COMPLAINED OF SHORTNESS OF BREATH AND SEVERE DISCOMFORT DURING NEPHROSTOMY TUBE PLACEMENT. THE PROCEDURE WAS DISCONTINUED. CHEST X-RAY DONE IMMEDIATELY AFTER THE PROCEDURE WAS NEGATIVE. NO EQUIPMENT MALFUNCTION OR ABNORMALITIES WERE NOTED. THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR NEPHROSTOMY TUBE PLACEMENT AND STATED WAS DIAGNOSED WITH A "COLLAPSED LUNG." NO CHEST TUBE WAS REQUIRED.
THE FOLEY CATHETER WAS DEFLATED WITH A 10CC SYRINGE TO FIND 8CC'S OF STERILE WATER REMOVED. ATTEMPTED TO DISCONTINUE FOLEY WHEN UNABLE TO PULL OUT COMPLETELY DUE TO RESISTANCE. ATTEMPTED TO WITHDRAW ADD'L WATER OUT OF BALLOON BUT NO FURTHER WATER REMOVED. ATTEMPTED TO WITHDRAW AGAIN AND MET RESISTANCE WITH 3" LEFT IN PT. FINALLY ABLE TO PULL OUT WITH MUCH GREATER FORCE THAN USUAL. THE BALLOON ON THE CATHETER WAS FOUND TO HAVE A RIDGE AROUND IT. SMALL AMOUNT OF BLOOD NOTED WHEN CLEANING PT UP.
IT WAS REPORTED TO CO THAT A 36 YEAR OLD FEMALE PT IN THE LATTER STAGE OF LUNG CANCER RECEIVED AN OVERDOSE OF MORPHINE. THE PT WAS SUPPOSED TO RECEIVE A 5MG/ML CONCENTRATION OF MORPHINE AT A RATE OF 2MG/HR. INSTEAD THE PT RECEIVED 70CC OF THE MORPHINE SOLUTION IN 1 HR AND 20 MIN.
THE PUMP WAS INCORRECTLY PROGRAMMED FOR THE DELIVERY OF PAIN MEDICATION. ATTACHMENT 1, SHOWS THE PROGRAMMING HISTORY FOR PUMP FROM JUNE 30 TO AUGUST 2, 1996. ON JULY 18, 1996 THE PUMP WAS PROGRAMMED FOR A TYPICAL PAIN CONTROL APPLICATION (PCA). ON JULY 18, 1996 THE PROFILE WAS CHANGED FROM A TYPICAL PCA APPLICATION TO A CONTINUOUS APPLICATION. THIS CONTINUOUS PROGRAMMED REMAINED THE TYPE OF PROFILE USED THROUGH THE SECOND OF AUGUST. THE INCIDENT REPORTED HERE OCCURRED ON AUGUST 1, 1996. IT WAS INTENDED TO BE A PAIN CONTROL APPLICATION REQUIRING THE PUMP TO BE PROGRAMMED FOR THE PCA PROFILE, AS WAS THE CASE ON JULY 18, 1996. AS CAN BE SEEN ON THE PROGRAMMING HISTORY SHEET, THE PUMP WAS INPROPERLY PROGRAMMED FOR THE APPLICATION IT WAS TO BE USED FOR. A COMPLETE COPY OF THE PUMPS DATA LOG FOR THE PERIOD OF JUNE 6 THROUGH AUGUST 12, 1996 IS ON FILE.
WHILE PERFORMING A PHACOEMULSIFICATION OF CATARACT AND PLACEMENT OF POSTERIOR CHAMBER IMPLANT, THE SURGEON TOUCHED THE CAPSULE WITH THE DEVICE TIP WITHOUT PHACO. THIS RESULTED IN AN IMMEDIATE SMALL TEAR IN THE POSTERIOR CAPSULE THAT ENLARGED. TO REPAIR THIS A MINIMAL ANTERIOR VITRECTOMY WAS PERFORMED.
NURSES OBSERVED RATES ON AN INFUSION PUMP CHANGING FROM 32 TO 137. ATTEMPTED TO CHANGE AND RESET PUMP USING HOLD POSITION SEVERAL TIMES WITH NO CHANGE NOTED. LCD WAS SHOWING "TURN TO RUN" MESSAGE. UNIT WAS TAKEN OUT OF SERVICE. DURING THE EVENT THE MEDICATION WAS CHANGED TO ANOTHER PUMP ON THE SAME UNIT WITHOUT ANY PROBLEMS.
ON 2/20/96 PT UNDERGOING POSTERIOR LUMBARSPINE DECOMPRESSION, FUSION AND INSTRUMENTATION HAD A STERILE SUBDERMAL RECORDING ELECTRODE PLACED IN THE LEFT VASTUS LATERALIS MUSCLE BY THE SPINE FELLOW. LARGE AMOUNTS OF ELECTRICAL NOISE PROMPTED THE NEUROPHYSIOLOGY TECHNOLOGIST TO CHECK THE SITE. THE NEEDLE HAD SEPARATED FROM SITE. THE NEEDLE HAD SEPARATED FROM THE WIRE. NEEDLE WAS VISUALIZED ON SUBSEQUENT AP & LATERAL FILMS. FOLLOWING COMPLETION OF THE CASE AN UNSUCCESSFUL ATTEMPT WAS MADE TO REMOVE THE NEEDLE FROM THE MUSCLE.
TWO EXPANDERS WERE RETURNED TO CO FOR PRODUCT EVALUATION. THE DEVICES WERE LABELED LEFT AND RIGHT. PE DESIGNATED THE LEFT DEVICE A AND THE RIGHT DEVICE B. PE AUTOCLAVED THESE DEVICES. DEVICE A HAD APPROX. 5 PUNCTURE SITES WITHIN THE PALPATION RING. A FOREIGN YELLOW SUBSTANCE WAS ON THE DEVICE WALL. A TRACE AMOUNT OF CLEAR FLUID WAS IN THE DEVICE. NO ANOMALIES WERE OBSERVED. DEVICE B HAD APPROX. 4 PUNCTURE SITES WITHIN THE PALPATION RING. A FOREIGN BROWN SUBSTANCE WAS AROUND THE SHELL PATCH. THE DEVICE CONTAINED A SMALL AMOUNT OF CLEAR FLUID. NO ANOMALIES WERE OBSERVED. DEVICE A WAS LEAK TESTED IN ACCORDANCE WITH CO PROCEDURES. LEAKAGE WAS OBSERVED FROM A RENT AT THE SHELL PATCH JUNCTION. THE RENT MEASURES APPROX. .5 CM IN LENGTH. DEVICE B WAS LEAK TESTED IN ACCORDANCE WITH CO PROCEDURES. LEAKAGE WAS OBSERVED FROM A RENT AT THE SHELL PATCH JUNCTION. THE RENT MEASURED APPROX. .3 CM IN LENGTH. DEVICE A'S AND B'S MICROSCOPIC EXAM OF THE EDGES OF THE RENTS REVEALED PARALLEL STRIATIONS. THE STRIATIONS OBSERVED HAVE MARKINGS THAT ARE SIMILAR TO MARKINGS THAT ARE GENERATED WHEN THE SHELL WALL COMES IN CONTACT WITH A SHARP INSTRUMENT. CO CONCLUDED THE REPORTED DEFLATION OF THE PT'S PROSTHESES WERE DUE TO A SHARP INSTRUMENT DAMAGE. A MICROSCOPIC EXAM OF THE EDGES OF THE RENTS, WHICH WERE LOCATED AT THE SHELL/PATCH JUNCTION'S OF THE DEVICES, REVEALED PARALLEL STRIATIONS WHICH ARE SIMILAR TO MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. BECAUSE CO PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PE CONCLUDED THE RENTS OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICES FROM THEIR PROTECTIVE PACKAGING.
REPORT RECEIVED ALLEGING MEDICAL ATTENTION WAS REQUIRED AFTER EXPERIENCING FIBER SEPARATION.
ONE PERSON, SERIOUS INJURY, TYPE G. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELLING? N. IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT THAN USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELLING? N. IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
CATHETER SPLIT ABOUT 4 1/4" FROM TIP OF CATHETER CAUSING IV ANTIBIOTICS TO "LEAK" INSIDE PT. SURGERY WAS NECESSARY TO REMOVE DEFECTIVE CATHETER AND TO INSERT TRIPLE LUMEN CENTRAL VENOUS CATHETER.
PT DIAGNOSED WITH SINOATRIAL NODE DYSFUNCTION. PLACEMENT OF PERMANENT PACEMAKER AND PACEMAKER LEAD ACCOMPLISHED 1-15-96. PT HAD CONTINUED INTERMITTENT FAILURE TO CAPTURE. DURING REVISION PROCEDURE 1-16-96 PHYSICIAN DETERMINED INSULATION BREAK IN OUTER INSULATION OF THE LEAD. THE LEAD WAS REMOVED INTACT AND REPLACED BY A NEW ATRIAL LEAD IN THE RIGHT ATRIUM WITH FLUOROSCOPIC GUIDANCE.
CHAIR RELEASED BACKWARDS ONE NOTCH AFTER BEING SET FOR SURGERY. NURSE ANESTHETIST CAUGHT THE CHAIR, AND THE PT, ALREADY UNCONSCIOUS FROM ANESTHETIC, WAS UNHARMED. SURGERY HAD NOT BEGUN; HOWEVER, THERE WAS CONCERN WITH THE POSSIBLE INJURY IF SURGERON HAD BEEN IN THE PROCESS OF OPERATING.
BEDRIDDEN, DISORIENTED, ELDERLY MALE RESIDENT ATTEMPTED TO LEAVE BED AROUND 11:10 PM AND SET OFF ALARM. STAFF RESPONDED AND TRIED TO COMFORT HIM BY OFFERING WATER AND CRACKERS. WHEN HE WAS SETTLED IN BED, THE DEVICE WAS RESET AND STAFF RETURNED TO STATION. FACILITY REPORTED THAT AFTER THEY LEFT, THE RESIDENT APPARENTLY REACHED BEHIND AND REMOVED THE UNIT FROM THE HEADBOARD OF THE BED SO THAT IT WOULD NOT ALARM WHEN HE DEPARTED. HE THEN ROLLED OUT OF BED, FELL AND BROKE HIS HIP. HE WAS ADMITTED TO THE HOSP AND UNDERWENT SURGERY AT THE REQUEST OF THE FAMILY TO SET THE FRACTURE. SUBSEQUENT TO THIS PROCEDURE HE DIED.
ON 2/7/96 AN IABP CATHETER WAS PLACED AND ADVANCED TO AORTIC KNOB. ON 2/10/96 BLOOD WAS NOTED TO BE IN THE IABP CATHETER WHEN FILLING AFTER THE HELIUM GAS LOSS ALARM SOUNDED. THE IABP CATHETER WAS REMOVED AND THE BALLOON WAS NOTED TO BE RUPTURED. ANOTHER IABP CATHETER WAS PLACED.
SIDE OF WHITE SUPPORTING TUBE BROKE OUT, COULDN'T FINISH GIVING MEDS AS FLUID WOULDN'T COME OUT OF SYRINGE. PLUNGER BECAME UNSTABLE.
PT PRESENTED TO THE EMERGENCY ROOM WITH A LACERATED LEFT THUMB. FOLLOWING EXAM BY THE PHYSICIAN, THE SKIN WAS PREPPED WITH BETADINE, THE WOUND CLEANED WITH STERILE SALINE, LOCAL ANESTHETIC OF 1% XYLOCAINE GIVEN, AN THE WOUND CLOSED WITH 4-0 SUTURES. GAUZE AND DRESSING WAS APPLIED. THE PT RETURNED TO THE EMERGENCY ROOM THREE DAYS LATER WITH A COMPLAINT OF SEVERE PAIN IN THE LEFT THUMB. SHE PRESENTED WITHOUT THE ORIGINAL DRESSING ON THE THUMB, HOWEVER, SHE INFORMED THE ER STAFF THAT THE DRESSING HAD BEEN TOOTIGHT. THE THUMB WAS FOUND TO BE NECROTIC FROM JUST PROXIMAL TO THE INTER PHALANGEAL JOINT. THE THUMB WAS CLEANSED WITH H202 AND NEOSPORIN APPLIED. A GAUZE AND STERILE DRESSING WAS APPLIED. THE PT WAS REFERRED TO A SPECIALIST FOR FOLLOW-UP. INFO REGARDING THE PT'S CONDITION REVEALED THAT DEBRIDEMENT OF THE WOUND HAD NOT BEEN SUCCESSFUL AND AMPUTATION OF THE TIP OF THE THUMB HAD BEEN PERFORMED.
PT BECAME UNRESPONSIVE AND HAD SEIZURE-LIKE MOVEMENTS FOLLOWING REPLACEMENT OF FLOLAN SYRINGE ON PUMP. PT WAS TO RECEIVE 2.3 CC/HR., AND IT APPEARS THAT THE ENTIRE SYRINGE (25CC) INFUSED IN APPROX. 15 MIN. ATIVAN AND SUPPLEMENTAL OXYGEN WERE ADMINISTERED. THE PT STABILIZED AND HAD NO FURTHER PROBLEMS.
PT WAS HAVING A STENT PLACEMENT WITH AN EXPANDABLE BALLOON. UPON INSERTION, THE BALLOON FAILED TO INFLATE PROPERLY. THE STENT AND BALLOON COULD NOT BE REMOVED DUE TO THE FACT THAT THE BALLOON WOULD NOT DEFLATE FOR REMOVAL. THE PT HAD TO GO TO SURGERY FOR REMOVAL OF THE STENT AND BALLOON. SUBSEQUENTLY, THE PT WAS ADMITTED TO THE ICU UNIT AFTER SURGERY AND IS ON A VENTILATOR.
PT WAS FOUND ON FLOOR NEXT TO HIS BED WITH AGONAL RESPIRATIONS, SURROUNDED BY A POOL OF BLOOD ABOUT HIS HEAD AND BODY-APPROX 2-3 LITERS. THE PERCUTANEOUS INTRODUCER SHEATH IN PT'S RIGHT INTERNAL JUGULAR VEIN FOUND TO BE LOOSE WITH BLOOD EXSANGUINATING. THE SHEATH WAS RECAPPED/SCREWED BACK ON IMMEDIATELY. CPR WAS INITIATED WITH ALL MEASURES TAKEN. AFTER APPROX. 50 MINUTES, PT WAS ASYSTOLIC AND PRONOUNCED DEAD. THE PT AND INTRODUCER SHEATH (IV LINE) WERE OBSERVED WITH NO PROBLEMS NOTED 28 MINUTES PRIOR TO THIS EVENT. TPN HAD BEEN INFUSING IN THIS LINE WITH NO PRIOR LEAKAGE.
PT UNDERWENT SURGERY TO REMOVE BILATERAL BREAST PROSTHESIS.
WOUND DRAIN SEPARATED AT THE JUNCTION BETWEEN THE TUBING AND THE PERFORATED PORTION WHILE BEING REMOVED FROM PT.
AIR LEAK DISCERNED FOLLOWING LOBECTOMY, NECESSITATING RETURN TO SURGERY FOLLOWING DAY. STAPLES VISUALIZED AT SITE, BUT CLOSURE NOT ACHIEVED.
SCRATCHES ON X-RAY FILM. SERVICEMAN REPLACED "G" ROLLERS.
FLASHING OCCLUSION. DISCONNECTED AND SENT BACK TO THE CO. REPAIRED AND RETURNED 2/8/96.
AIR LEAK DISCERNED FOLLOWING LOBECTOMY, NECESSITATING RETURN TO SURGERY FOLLOWING DAY. STAPLES VISUALIZED AT SITE, BUT CLOSURE NOT ACHIEVED. PT DISCHARGED IN EXPECTED CONDITION.
PUMP MALFUNCTIONS: ERR ON WHEN POWER IS TURNED ON. DISCONNECTED AND SENT BACK TO THE CO. PUMP REPAIRED AND RETURNED 2/8/96.
TIP OF SUTURE NEEDLE BROKE OFF DURING REPEAT C-SECTION. UNSUCCESSFUL SEARCH FOR NEEDLE TIP EXTENDED SURGERY TIME.
TWO EXTERNAL PUMPS NOT WORKING. PLEASE SEND BACK TO THE CO AND REPLACE. FIRST PUMP: ERR ON WHEN POWER IS TURNED ON. SECOND PUMO FLASHING OCCLUSION.
REPAIR TO COLLIMATOR AS SURGGESTED BY RADIATION PROTECTION. MEDICAL IMAGING SVC TECH REPAIRED  COLLIMATOR.
SCRATCHES ON X-RAY FILM. SERVICEMAN ADJUSTED ROLLER.
RECALIBRATED TUBE AND RECKED LOW KV. SVC TECH FROM REPAIRED MACHINE.
THE PT PULLED OUT HIS FOLEY CATHETER. UPON INSPECTION IT WAS DETERMINED THAT THE BALLOON HAD BROKEN. THE PT WAS TAKEN TO THE OPERATING ROOM FOR A CYSTOSCOPIC EXAM TO INSURE THAT THERE WERE NO BALLOON FRAGMENTS WERE FOUND. THE PT REQUIRED OVERNIGHT HOSPITALIZATION FOR OBSERVATION. THE PT WAS DISCHARGED THE FOLLOWING DAY WITHOUT ANY PROBLEMS RELATED TO THE EVENT.
TANKS ARE LEAKING AT THE OVERFLOW. NEED TO REPLACE TANKS.
PROCESSOR LEAKING AND STUDS WILL NOT STAY IN WASH RACK SIDE PLATE. TIGHTENED ALL CLAMPS AND REPLACED STUDS IN WASH RACK.
TIP OF INSERTER BROKE OFF DURING INSERTION. PLASTIC INSERTER TIP FOUND TO BE BENT AFTER PROCEDURE. LENS TORN; THIS OCCURRED WITH TWO DIFFERENT PTS. NO PT INJURY.
PUMP CONTINUES TO BEEP AFTER BEING TURNED OFF AND UNPLUGGED. DISCONNECTED AND SENT BACK TO THE CO. REPLACED BY CO AND BEING USED ON UNIT.
CANNOT GET A CASSETTE IN, THE METAL PIECE IS BROKEN. DISCONNECTED AND SENT BACK TO THE CO TO BE REPLACED. PUMP REPLACED BY CO AND BEING USED ON UNIT.
COMPUTER READS "LOW BATT" EVEN WHEN PLUGGED INTO A RECEPTACLE IN WHICH OTHER THINGS WORK. DISCONNECTED AND SENT BACK TO THE CO. REPLACED BY CO AND BEING USED ON UNIT.
PUMP WOULD NOT TURN OFF EVEN WHEN UNPLUGGED, HAD TO DISCONNECT THE BATTERY. SENT TO CO TO BE REPAIRED.
READS ERR. CALLED SERVICE REP TO COME FIX PUMP. FIXED AND BEING USED ON UNIT.
ERROR H. DISCONNECTED AND GIVEN TO SENT BACK TO THE CO. REPAIRED BY SVC REP AND BEING USED ON UNIT.
CHEMICAL TANKS INSIDE OF PROCESSOR LEAKING. REPLACED PROCESSING TANK ASSEMBLY.
PUMP WILL NOT CUT OFF AND CONTINUES TO BEEP. DISCONNECTED AND SENT BACK TO THE CO TO BE REPLACED.
PT WITH SQUAMOUS CELL CARCINOMA OF THE VAGINA UNDERWENT A RADICAL  HYSTERECTOMY, PELVIC LYMPH NODE DISSECTION AND VAGINECTOMY WITH REMOVAL OF ALL GROSS DISEASE. AT THE TIME OF SURGERY TWO DRAINS WERE PLACED. ON POST-OP DAY SIX, THE LEFT DRAIN WAS REMOVED WITH INCIDENT AND UPON REMOVAL OF THE RIGHT DRAIN, THE DRAIN BROKE. AN ATTEMPT WAS MADE TO VISUALIZE THE DISTAL END OF THE CATHETER THROUGH THE DRAIN INCISION. HOWEVER, THE DISTAL  END OF THE DRAIN HAD RETRACTED BELOW THE LEVEL OF THE FASCIA. THE PT WAS IMMEDIATELY TAKEN TO THE OPERATING ROOM AND UNDERWENT SURGERY FOR A LAPAROTOMY TO REMOVE THE RETAINED PIECE OF THE DRAIN.
ON 8/17/95, THE PT UNDERWENT A LAR (LOWER ANTERI RESECTION) OF RECTAL CARCINOMA. A 7 CM DRAIN WAS PLACED IN THE LOWER RIGHT QUADRANT. THE WOUND REMAINED DRY AND CLEAN POSTOPERATIVELY. ON 8/22/95, THE DRAIN WAS REMOVED. DURING THIS REMOVAL, THE DRAIN FRACTURED AND TUBING REMAINED IN THE PELVIS. ON 8/23/95, THE PT RETURNED TO THE OPERATING ROOM FOR REMOVAL VIA LAPAROTOMY.
PT UNDERWENT A RADICAL PROSTATECTOMY AND DURING THE PROCEDURE A DRAIN WAS PLACED. ON POSTOP DAY 3 (1-27-96). UPON REMOVING THE DRAIN, THE DRAIN FRACTURED AND A PORTION WAS RETAINED IN THE PELVIS. THE PT RETURNED TO THE OR FOR REMOVAL OF THE RETAINED PORTION.
ON 2/19/96, PT UNDERWENT A RIGHT AXILLARY LYMPH NODE DISSECTION AND RIGHT BREAST RE-EXCISION. DURING THE SURGERY A 7MM FLAT DRAIN WAS PLACED. ON 2/20/96, NURSES NOTE THAT DRAIN HAS SHORT PERIODS OF SUCTION AND DRAIN HAD TO BE RESET EVERY 10 MINUTES. PT WAS INSTRUCTED ON HOW TO RESET DRAIN AND WAS DISCHARGED WITH DRAIN IN PLACE. UPON REMOVAL OF DRAIN (EXPECTED WITHIN THE NEXT WEEK) RPTR WILL FORWARD FOR EVALUATION AND INSPECTION.
ON 2/19/96, PT UNDERWENT A RIGHT TOTAL MASTECTOMY. DURING SURGERY 2 DRAINS WERE PLACED. POST-OPERATIVELY IT WAS NOTED THAT DRAIN # 2 HAD TO BE RESET EVERY 15 MINUTES. THE PT WAS INSTRUCTED HOW TO RESET DRAIN AND WAS DISCHARGED HOME WITH DRAIN. RPTR WILL FORWARD TO MFR FOR INSPECTION.
PT ADMITTED FOR EXTRACTION OF DEGENERATED ATRIAL PACEMAKER LEAD. ACCORDING TO MFR, LEAD HAD BEEN RECALLED. THE TRANSVENOUS EXTRACTION WAS COMPLICATED BY INTRA-OPERATIVE HEMORRHAGE REQUIRING MEDIAN STERNOTOMY. DISCLOSED THAT ONE OF THE ELECTRODES WAS PENETRATING THE SUPERIOR VENA CAVA POSTERIORLY AT THE LEVEL OF THE AZYGOUS VEIN AND WAS INTO THE RIGHT PLEURAL CAVITY. NUMEROUS UNITS OF BLOOD AND BLOOD COMPONENTS WERE TRANSFUSED. THE PT STABILIZED AND SENT TO THE SPECIAL CARE UNIT. PT EXPIRED SEVERAL HRS LATER.
RESIDENT WAS SITTING IN WHEELCHAIR WITH REMINDER BELT FASTENED (UNSURE WHAT LENGTH OF DEVICE FASTENED). RESIDENT LEANED FORWARD, DEVICE LET LOOSE, RESIDENT FELL OUT OF WHEELCHAIR RESULTING IN LACERATION NEEDING SUTURES AND BRUISING OVER RIGHT EYE.
ON 2/19/96, PT UNDERWENT LEFT BREAST EXCISION AND AUXILLARY LYMPH NODE DISSECTION. DURING THE SURGERY A DRAIN WAS INSERTED. ON 2/20/96, DRAIN WAS NOTED TO HAVE SHORT PERIODS OF SUCTION. DRAIN HAD TO BE RESET EVERY 15 MINUTES. PT DISCHARGED HOME WITH DRAIN IN PLACE AND INSTRUCTIONS ON HOW TO RESET DRAIN.
A PEDIATRIC PT EXPERIENCED A DROP IN BLOOD PRESSURE AND HEMOGLOBIN, AS WELL AS HYPOVOLEMIA WHILE ON THE APHERESIS MACHINE. THIS REQUIRED IMMEDIATE FLUID VOLUME REPLACEMENT. SPILL OVER OF THE PT'S PLASMA INTO BAG WAS APPROX 300CC'S. ALSO, MACHINE DID NOT RETURN BLOOD TO PT. HYPOVOLEMIC STATE WAS REVERSED FOLLOWING 250CC OF PLASMA, IV FLUID BOLUS AND RBC TRANSFUSION.
ON 2/19/96, PT UNDERWENT SURGICAL PROCEDURE AND A DRAIN WAS PLACED POSTOPERATIVELY. DRAIN LOST SUCTION AND CAP FELL OFF. CAP PUT BACK ON AN EVACUATOR; STILL LOST SUCTION EVERY 15 MINUTES. PT IS CURRENTLY IN HOSP AND DRAIN IS IN PLACED. PT INSTRUCTED TO RE-SET DRAIN FREQUENTLY. UPON REMOVAL OF DRAIN RPTR WILL FORWARD TO MFR.
PT WAS TRANSPORTED FROM MEDICAL FLOOR TO CCU. DURING TRANSFER FROM ONE BED TO NEXT, PORTABLE O2 TANK WAS TURNED OVER AND IT LEAKED TO PT'S LOWER EXTREMITIES, CAUSING FROSTBITE. COMPRESSES APPLIED PER EMERGENCY DEPT PROTOCOL. CONSULT TO PLASTIC SURGERY DONE IMMEDIATELY.
DURING DRAINAGE TUBE INSERTION, THE CATHETER WAS PLACED OVER THE GUIDEWIRE AND THEN WITHDRAWN. RESISTANCE WAS ENCOUNTERED UPON WITHDRAWAL. DURING THE COURSE OF THE GUIDEWIRE WITHDRAWAL, THE FLEXIBLE COLIED OUTER LAYER BECAME UNWOUND AND ONCE THE CATHETER WAS REMOVED, THE SOLID CORE WAS INSPECTED AND IT WAS FELT THAT A SMALL SEGMENT OF THE INNER CORE MAY HAVE BROKEN OFF. KUB WAS DONE; ADJACENT TO THE CATHETER TIP WAS A SMALL SEGMENT OF GUIDEWIRE IMBEDDED IN THE CATHETER.
PT HAD 8F INTRODUCER WITH DETACHABLE SIDE PORT/HEMOSTASIS VALVE CATHETER IN PLACE. TUBING BECAME DISCONNECTED, PT BLED AND SUBSEQUENTLY EXPIRED.
TABLE'S HYDRAULIC MECHANISM FAILED. SET SCREWS STRIPPED PER REPAIR TEAM. PT HAD TO BE TRANSFERRED TO ANOTHER HOSP TO COMPLETE SURGERY FOR FRACTURED FEMUR. BED FELL FROM ELEVATED POSITION TO LOWER POSITION.
THE DORSAL COLUMN STIMULATOR LEAD WAS TESTED AND FOUND TO BE NONFUNCTIONAL. THIS WAS REMOVED SURGICALLY AND REPLACED.
BED ROLLED OVER WITH PT AND PT FELL TO FLOOR WITH BED. RETAINING PIN IN BED WAS ON THE FLOOR.
UNPLUGGED CHARGER FROM WALL. CHARGER CAME APART AND THE HOSP PROFESSIONAL RECEIVED A SHOCK. VERBAL REPORT WAS GIVEN TO CO ON 2/21/96. WRITTEN REPORT COMPLETED AND SENT 2/27/96.
HEALTH CARE PROFESSIONAL WAS UNPLUGGING THE PULSE OXIMETER CHARGER FROM THE WALL OUTLET AND THE PULSE OXIMETER CHARGER BROKE. NO PHYSICAL INCIDENT TO  THE HEALTH CARE PROFESSIONAL. VERBAL REPORT WAS GIVEN TO CO EMPLOYEE ON 2/29/96. WRITTEN REPORT COMPLETED AND SENT TO CO 2/29/96.
PT WAS FOUND LYING ON THE FLOOR. THE DEVICE HAD NOT ALARMED. PRIOR TO THAT FALL THE PT HAD GOTTEN OUT OF BED AND THE DEVICE HAD ALARMED. FOLLOWING THE INCIDENT THE DEVICE WAS INSPECTED BY A BIOMED AND THE DEVICE WAS OPERATING PROPERLY. TESTING WAS UNABLE TO IDENTIFY A PROBLEM. COULD IT BE AN INTERMITTENT ALARM PROBLEM?
MALFUNCTION OF ELECTROCAUTERY PENCIL DURING CAROTID ENDARTERECTOMY. DEVICE  APPEARED TO BE AT HIGH POWER EVEN WHEN TURNED OFF. PRODUCED NEAR TRANSECTION OF STERNOCLEIDOMASTOID MUSCLE AND LACERATION OF INTERNAL JUGULAR VEIN. SURGICAL REPAIR PERFORMED AND PT DISCHARGED WITHOUT COMPLICATIONS.
PART OF A PORT-A-CATH WAS FOUND TO BE EMBOLIZED TO THE PULMONARY VESSELS IN 1/96. PT WAS TRANSFERRED TO HOSP AT WHICH POINT THE EMBOLIZED SEGMENT WAS REMOVED VIA INTERVENTIONAL RADIOLOGY. PT RETURNED, WITH RESPECT TO REMOVAL OF THE REMAINDER OF THE PORT-A-CATH. A RIGHT SUBCLAVIAN PORT-A-CATH WAS REMOVED WITH NO COMPLICATIONS AND NO DIFFICULTIES WERE NOTED IN A SUBSEQUENT FOLLOW-UP VISIT.
ON 5/1/96 NG TUBE WAS BEING REMOVED. THERE WAS NOTED RESISTANCE UPON ATTEMPTED REMOVAL. WHEN TUBE WAS REMOVED THERE WAS A KNOT AT THE END OF THE TUBE. PT DID EXPERIENCE SOFT TISSUE INJURY AND CONSULTING ENT WAS CALLED IN.
MALFUNCTION OF ELECTROCAUTERY PENCIL DURING CAROTID ENDARTERECTOMY. DEVICE APPEARED TO BE AT A HIGH POWER EVEN WHEN TURNED OFF. PRODUCED NEAR TRANSECTION OF STERNOCLEIDOMASTOID MUSCLE AND LACERATION OF INTERNAL JUGULAR VEIN. SURGICAL REPAIR PERFORMED AND PT DISCHARGED WITHOUT COMPLICATIONS.
DISTAL END CATHETER BROKE OFF AND MIGRATED TO RIGHT VENTRICLE OF HEART. REQUIRED SURGICAL INTERVENTION TO REMOVE DISTAL CATHETER.
CARDIOPULMONARY TECHNICIAN WAS ATTEMPTING TO SUCTION FROM A SAFETY DRAIN CONNECTED TO A CIRCUIT ON A VENTILATOR. DURING SUCTION THE TECHNICIAN NOTICED THE CIRCUIT EXPAND AND THE EXHALATION VALVE ALARM AND THE PEEK PRESSURE ALARM SOUNDED. THE CIRCUIT WAS REMOVED FOR THE PT AND THE PT WAS BAGGED. THERE WERE NOT ADVERSE PT OUTCOMES.
PT RECEIVED CATHETER ON 2/5/96. ON 2/7/96 RETURNED TO CLINIC AND NO BLOOD COULD BE RETURNED FROM THE CATHETER. UNDER FLUOROSCOPY THE CATHETER WAS NOTED TO BE DETACHED FROM THE PORT AND COILED IN THE RIGHT VENTRICLE. PORT  WAS IMMEDIATELY REMOVED FROM LEFT INNER ARM, AND SENT TO HOSP FOR REMOVAL OF CATHETER FROM HER HEART. THE LOCKING MECHANISM ON THE PORT FAILED TO SECURE THE CATHETER.
A VACUUM EXTRACTOR WAS USED DURING A VAGINAL DELIVERY. THE INFANT SUSTAINED A FATAL CEPHALOHEMATOMA DUE TO THE VACUUM EXTRACTOR. AUTOPSY WAS PERFORMED ON 6/4/96. AUTOPSY DID NOT REVEAL ANY OTHER POTENTIAL CAUSE OF DEATH.
PT APPARENTLY BECAME DISCONNECTED FROM THE VENTILATOR. NO ALARMS WERE HEARD UNTIL THE CARDIAC MONITOR ALARMED. PT ASYSTOLIC AND CYANOTIC; COMPRESSIONS INITIATED WITH SUCCESS. IT WAS REPORTED THAT THE VENTILATOR WOULD ALARM IF THE PT CIRCUIT WAS DETACHED, BUT IF THE CIRCUIT AND SENSOR DETACHED IT WOULD NOT ALARM. NO PROBLEM FOUND WITH EITHER THE VENTILATOR OR MONITOR. HOWEVER, AN INFANT FLOW SENSOR WAS BEING USED FOR FLOW RATES OF GREATER THAN 20. THE EXCESSIVE FLOW THROUGH THE INFANT SENSOR RESULTED IN TURBULANCE THAT GENERATED PRESSURES HIGH ENOUGH TO AVOID TRIGGERING THE VENT ALARMS. THE UNIT WAS PULLED FROM SERVICE TO EVALUATE. THE INFO CONCERNING THIS UNIT, ALONG WITH THE NEED TO USE A PEDIATRIC SENSOR FOR FLOWS OF 2-120 LPM AND WHEN IN VOLUME CYCLED MODES WAS COMMUNICATED TO STAFF.
ENTERAL FEEDING PUMP INFUSED JEVITY TOO FAST.
RT HEART CATH VIA RT AND LF FV, RFA ANGIO PERFORMED 5/15/96. DURING OCCLUSION OF ASD WITH 7.FR BALLOON WEDGE CATHETER, BALLOON RUPTURE OCURRED FOLLOWED BY BRADYCARDIA, WIDE QRS COMPLEX, RHYTHM TO 60'S AS WELL AS HYPOTENSION TO 60-70 SYSTOLIC. PT AMBUED AND GIVEN ATROPINE AND ISUPREL WITH RESOLUTION OF WIDE QRS. ADMITTED TO ICU FOR OBSERVATION. DISCHARGED HOME 5/16/96.
MEDICAL DEVICE EMITTED A LOUD SCREECHING NOISE WHEN USED.
INFUSION OF HEPARIN 25,000 UNITS IN 250CC NORMAL SALINE HUNG AT 1:00PM TO RUN AT 20CC/HR. 250CC INFUSED OVER 5.5 HOURS RATHER THAN 12.5. HEPARIN HELD FOR SEVERAL HRS. PUMP TESTED BY BIOMEDICAL ENGINEERING AND FOUND TO BE INTERMITTENTLY OVERFUSING.
INFUSION OF HEPARIN 25,000 UNITS IN 250CC NORMAL SALINE SET TO INFUSE AT 19 CC/HR. TOTAL VOLUME (250CC) INFUSED OVER 9 HOURS INSTEAD OF 13 HOURS. HEPARIN HELD FOR 2 HOURS. PUMP TESTED BY BIOMEDICAL ENGINEERING, NO PROBLEM FOUND.
PT HAD SURGERY FOR BRAIN ANEURYSM-PT DETRIORATED IN RECOVERY ROOM AND WAS INTUBATED AND SENT FOR BRAIN SCAN WHERE ADD'L BLEEDING IN BRAIN WAS NOTED. PT HAD EMERGENCY RE-OPERATION. ACCORDING TO SURGEON, THE ANEURYSM CLIP HAD SLIPPED, WHICH CAUSED THE ADD'L BLEED. ADD'L CLIP APPLIED.
PT HAD A TPN SINGLE LUMEN CATHETER PLACED AT HOSP 3/31/93. POST PROCEDURE CHEST X-RAY SHOWED LEFT SUBCLAVIAN CATHETER WITH THE TIP IN THE RIGHT ATRIUM. 7/29/93, CHEST XRAY SHOWED SOME POSSIBLE KINKING OF THE CATHETER AT THE SKIN ENTRANCE SITE. 7/16/93 CHEST XRAY SHOWED THE CATHETER HAD PULLED BACK INTO THE SUBCLAVIAN VEIN AND DISTALLY TO THAT. UPON IRRIGATION, BLOOD HAD SEEPED AROUND THE OPENING AT THE SKIN ENTRY. THE CATHETER WAS REMOVED. 10/6/94 CHEST X-RAY AT HOSP SHOWED WHAT APPEARED TO BE A PORTION OF THE CATHETER IN THE PT'S MAIN PULMONARY ARTERY AND/OR PULMONARY OUTFLOW TRACT. 10/11/94 CT OF THE THORAX AT HOSP CONFIRMED THE PORTION OF CATHETER IN THE LEFT MAIN PULMONARY ARTERY. APPARENTLY, THE PT HAD A SEVERAL MONTH HISTORY OF CHEST DISCOMFORT AND EXERTIONAL DYSPNEA. 10/19/94 THE CATHETER FRAGMENT WAS REMOVED AT HOSP VIA THE PERCUTANEOUS FEMORAL VENOUS APPROACH. HOSP WAS NOT AWARE OF THE PRODUCT PROBLEM UNTIL NOTICE OF INTENT TO FILE CLAIM WAS RECEIVED 7/14/95. RPTR IS FILLING THE REPORT AFTER NOT BEING ABLE TO DETERMINE WHETHER A REPORT WAS MADE AT THE TIME THE CATHETER WAS REMOVED.
ASSOCIATE WAS IN THE PROCESS OF LINING UP THE PINHOLE COLLIMATOR TO BE PLACED AND SECURED ON THE SURFACE OF THE DETECTOR HEAD WHEN PT FELL OFF OF ITS STAND AND ONTO THE FLOOR. WT OF COLLIMATOR 500 LBS. NO INJURY TO PTS OR ASSOCIATE. MFR NOTIFIED OF INCIDENT 5/23/96 AND EXAMINED EQUIPMENT ON-SITE. COLLIMATOR IN THE PROCESS OF BEING RETURNED TO THE MFR.
PT UNDERWENT URETEROSCOPY WITH STONE MANIPULATION AND LASER LITHOTRIPSY-WITH 320 MICRON FIBER THROUGH BASKET. THE LASER WAND BROKE OFF AT THE OPENING INTO THE STONE BASKET. IT WAS NOT TWISTED OR TURNED. THE PHYSICIAN HAD TO RELEASE THE STONE TO REMOVE THE BASKET SO THAT THE LASER FRAGMENT COULD BE RETRIEVED. PART OF THE CALCULUS MIGRATED TO THE KIDNEY. A SECOND PROCEDURE WILL BE REQUIRED TO REMOVE THE CALCULUS.
PT UNDERWENT EMERGENCY SURGERY WHEN IT WAS DISCOVERED THAT SHE HAD A PIECE OF WIRE PENETRATING HER HEART ATRIUM. 1 1/2" WIRE REMOVED. PT HAD PACEMAKER IN PLACE. WIRE BELIEVED TO BE FROM PACING LEAD. PACING LEAD STILL IN PLACE IN PT'S HEART.
CNA WAS POSITIONING CO STRETCHER LIFT SCALE NEXT TO RESIDENT'S BED IN PREPARATION TO TRANSFER RESIDENT INTO BED. CNA STATES HE TURNED AWAY TO CALL FOR 2ND CNA TO ASSIST WITH TRANSFER, AND NOTICED RESIDENT MOVING HANDS IN AIR. AS SHE REACHED, SHE FELL TO FLOOR. CNA STATES ONE STRAP WAS SECURED ABOUT RESIDENT PRIOR TO INCIDENT. RESIDENT TRANSPORTED TO EMERGENCY ROOM VIA AMBULANCE FOR TREATMENT OF LACERATIONS AND HEMATOMA BELOW RT. EYE; HEMATOMA RT. TEMPORAL AREA; INVOLVEMENT OF SWOLLEN, ECCHYMOTIC NOSE. CT SCAN DONE-REVEALED NO FRACTURE; ONE SUTURE TO LACERTION BELOW RT. EYE. INCIDENT INVESTIGATED IMMEDIATELY. CNA STATES BELT BUCKLE WAS SECURELY LOCKED PRIOR TO INCIDENT. RELEASE OF BUCKLE COULD ONLY BE DONE WHEN BUCKLE BECAME CAUGHT AGAINST FRAME OF STRETCHER. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT INSTRUCTIONS FOR USE CALL FOR TWO BELTS TOB BE SECURED TO THE STRETCHER IN HOLDERS ON THE UNDERSIDE. STAFF ON DUTY WERE VERBALLY AND VISUALLY GIVEN PROPER INSTRUCTIONS.
PT WAS RECEIVING MAGNESIUM SULFATE VIA CO'S INFUSION PUMP. THE PT'S PHYSICIAN ORDERED THE MEDICATION STOPPED. A STAFF RN STOPPED THE INFUSION BY PUSHING APPROPRIATE BUTTON. THE STAFF MEMBER THEN LEFT THE ROOM WITHOUT YET DISCONNECTING THE IV FROM THE PT. APPROX 20 MIN LATER STAFF ENTERED THE ROOM AND FOUND THAT THE PUMP DOOR WAS OPENED AND TUBING WAS OUTSIDE THE PUMP STILL CONNECTED TO THE PT. THIS CREATED A FREE FLOWING IV TO THE PT. IT IS ESTIMATED THAT THE PT RECEIVED APPROX 178 CC OF IV LACTATED          RINGERS WITH MAGNESIUM SULFATE). IT IS UNKNOWN WHO OPENED THE PUMP AND REMOVED THE TUBING. APPROPRIATE ANTIDOTES WERE GIVEN THE PT TO COUNTERACT THE MAGNESIUM SULFATE.
CAUTERY PENCIL DID NOT SHUT OFF AFTER BEING DEACTIVATED. CAUTERY PENCIL WAS SET DOWN ON OPERATIVE FIELD AND BURNED PT'S LEFT FOURTH FINGER. PENCIL'S HAVE BEEN DISCONTINUED UNTIL FOLLOW-UP IS COMPLETE.
A 5 YR OLD PT WAS IN ER FOR SUTURE OF LACERATED SCALP. DR DECIDED TO UTILIZE THIS STAPLE INSTEAD OF SUTURES. THE STAPLE GUN JAMMED AND 2 PEOPLE HAD TO HOLD DOWN THE CHILD, SCREAMING AND NOW BLEEDING, WHILE THE DR PRIED THE JAMMED STAPLE GUN OFF THE CHILD'S HEAD WITH A PAIR OF SURGICAL SCISSORS. PT AND FATHER VERY UPSET. FATHER WORKS FOR A CO WHO MAKES PARTS FOR MFR OF STAPLER. FATHER APPARENTLY TOOK THE DEVICE HOME.
THIRD EVENT OF THIS TYPE. MEDWATCH FORM FILED WITH CAUTERY PENCIL VENDOR ORIGINALLY. PENCILS WERE REPLACED WITH CO'S CAUTERY PENCILS. IT WAS ORIGINALLY THOUGHT THAT THE PENCIL HAD CAUSED THE EVENT. ON 2/26/96 THE NEW CAUTERY PENCIL DID NOT SHUT OFF. CAUTERY PENCIL SWITCHED TO ANOTHER CAUTERY UNIT AND WORKED FINE. DEVICE TAKEN OUT OF SVC 2/26/96. CAUTERY UNIT CHECKED BY BIOMEDICAL CONTRACT PERSONNEL CONTACTED ON 2/29/96. PRODUCT WILL BE RETURNED TO VENDOR UNDER RGA A7679. PREVIOUS CAUTERY VENDOR HAS BEEN NOTIFIED ABOUT THIS THIRD EVENT. WILL WAIT FOR FOLLOW FROM VENDOR.
5 YR OLD PT WAS IN ER FOR SUTURE OF LACERATED SCALP. DR DECIDED TO UTILIZE THIS STAPLE GUN INSTEAD OF SUTURES. THE STAPLE GUN JAMMED AND 2 PEOPLE HAD TO HOLD DOWN THE CHILD, SCREAMING AND NOW BLEEDING, WHILE THE DR PRIED THE JAMMED STAPLE GUN OFF THE CHILD'S HEAD WITH A PAIR OF SURGICAL SCISSORS. PT AND FATHER VERY UPSET. FATHER WORKS FOR MFR OF STAPLER. FATHER APPARENTLY TOOK THE DEVICE HOME.
ADMITTED FOLLOWING EPISODE OF SYNCOPE. HAD SYNCOPE ASSOCIATED WITH ASYSTOLE IN HOSP. PERMANENT PACER PLACED. PT HAD CARDIAC ARREST 4/5/96, 4/6/96. PACEMAKER FAILED TO CAPTURE. THERE WAS UNSUCCESSFUL RESUSCITATION , PT EXPIRED ON 4/6/96. NO AUTOPSY WAS DONE.
NEW IVF BAG HUNG AND RATE PROGRAMMED TO DELIVER AT 120 CC/HR. PUMP ALARMED 1 HR AFTER BAG WAS HUNG AND IT WAS EMPTY. TUBING WAS PROPERLY PLACED.
PT RECEIVED IV BOLUS OF CARDIZEM AND WAS ORDERED MAINTENANCE IV DRIP OF CARDIZEM 5MG PER HR - 125 ML PROGRAMMED INTO PUMP AND PT RECEIVED 125 MG IN ONE HR. 5MG WAS THE VOLUME PROGRAMMED IN AND DID NOT ALARM WHEN 5MG INFUSED.
A PLASTIC CLAMP ON THE FEMORAL TIP BROKE AND FELL INTO THE PT'S FEMORAL CANAL DURING A TOTAL HIP REPLACEMENT. THE CLAMP WAS RETRIEVED BY THE SURGEON AND THE PT SUFFERED NO ILL EFFECTS.
WHILE RN WAS DRAWING UP VERSED INTO A TB SYRINGE, SHE NOTICED A SMALL PARTICLE OF BLACK RUBBER FROM THE PLUNGER FLOATING INSIDE THE SYRINGE. MEDICATION WAS WASTED DUE TO CONTAMINATION AND POSSIBLE DANGER TO PT IF IT HAD BEEN ADMINISTERED.
INFLATABLE VALVE ON PROSTHESIS MALFUNCTIONED.
A PT WITH KNOWN METASTATIC LUNG CANCER, UNDERWENT A CT SCAN OF THE HEAD TO RULE OUT BRAIN METASTASES ON 2/26/96. TWO ABNORMALITIES WERE NOTED ON THE STUDY AND RADIOSURGERY TO BOTH LESIONS WERE ADMINISTERED. THE FOLLOWING DAY, WHEN THE CT STUDY WAS REVIEWED BY THE CHIEF OF THE DIVISION OF NEURORADIOLOGY, ONE OF THE ABNORMALITIES NOTED TO BE A LESION WAS PROBABLY AN ARTIFACT. CO WAS NOTIFIED AND THE SCANNER HAD A NEW MAGNETIC TUBE INSTALLED. THE DEVICE FUNCTIONED PROPERLY AFTERWARDS. THERE WAS NO EVIDENCE OF SEQUELAE TO THE PT, WHO WAS APPRISED OF THE OCCURRENCE.
TWIN A, THE PRODUCT OF A 22 WEEK GESTATION WAS BEING RESUSCITATED WITH A NEONATE MANUAL RESUSCITATOR FOR ONE OF A SERIES OF EPISODES OF OXYGEN DESATURATION. THE NURSE AMBUED THE PT WITHOUT RESULT. AFTER SEVERAL MOMENTS AND A NUMBER OF INTERVAL ACTIONS THE DEVICE WAS SWITCHED FOR A DIFFERENT ONE AND THE PT'S OXYGEN SATURATIONS INCREASED TO THE 90'S. UPON INSPECTION  OF THE DEVICE IT WAS APPARENT THAT A LOCKING RING NORMALLY CONTAINED IN THE SEALED PORTION OF THE NECK OF THE DEVICE WAS NOT PRESENT. THE PT RETURNED TO BASELINE FOLLOWING THE INCIDENT.
DURING PTCA, A .014 GUIDE WIRE WAS ADVANCED TO THE POSTERIOR DESCENDING ARTERY. THE INTRODUCER WAS THEN CARRIED TO THE POSTERIOR DESCENDING ARTERY AND THE GUIDE WIRE WAS EXCHANGED FOR A .014 EXTRA SUPPORT WIRE. THE PHYSICIAN THEN ADVANCED A STENT TO THE OSTIUM OF THE LEFT CORONARY ARTERY. DESPITE REPEATED ATTEMPTS, RPTR COULD NOT ADVANCE THE STENT BEYOND THE PROXIMAL THIRD OF THE LEFT CIRCUMFLEX ARTERY. RPTR ELECTED THEN TO REMOVE THE STENT FROM THE CORONARY ARTERY. IN PULLING THE STENT BACK INTO THE GUIDING CATHETER, IT APPEARED THAT THE STENT WAS DISLODGED FROM THE BALLOON CATHETER. THE STENT CATHETER WAS THEN REMOVED WITH THE WIRE LEFT IN PLACE. A 1.5 BALLOON CATHETER WAS THEN ADVANCED OVER THE GUIDE WIRE AND THROUGH  THE STENT WHICH WAS LOCATED AT THE OSTIUM OF THE LEFT MAIN CORONARY ARTERY. THE BALLOON CATHETER WAS THEN BROUGHT INTO THE GUIDING CATHETER AND THE GUIDING CATHETER, BALLOON CATHETER, STENT AND GUIDE WIRE WERE PULLED BACK. REVIEW OF THE FILMS, IT APPEARED THAT THE STENT WAS STILL IN PLACE AS RPTR MOVED THROUGH THE ABDOMINAL AORTA BUT THE STENT WAS NOT RECOVERED WHEN RPTR REMOVED THE CATHETER FROM THE ROOT OF THE CATHETER AND SHEATH. RPTR BELIEVES THAT THE STENT SOMEHOW WAS EMBOLIZED IN THE ABDOMINAL AORTA AND PROBABLY MOVED TO THE LOWER EXTREMITIES. A NEW SHEATH WAS PLACED IN THE RIGHT FEMORAL ARTERY. A DIAGNOSTIC CATHETER WAS THEN ADVANCED TO THE LEFT CORONARY ARTERY AND FINAL ANGIOGRAMS PERFORMED. THE LEFT MAIN CORONARY ARTERY WAS NORMAL. IN THE PROXIMAL THIRD OF THE LEFT CIRCUMFLEX ARTERY, THERE WAS A SMALL LINEAR DISSECTION WITHOUT SIGNIFICANT LUMINAL COMPROMISE. RPTR SUSPECTS THAT THIS OCCURRED WITH PLACEMENT OF THE STENT. THE OBTUSE MARGINAL BRANCH WHICH WAS TOTALLY OCCLUDED REMAINED PATENT WITH A 20 TO 30% STENOSIS IN ITS PROXIMAL THIRD AND A 50% ECCENTRIC STENOSIS IN THE DISTAL THIRD.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT WAS PLACED ON VENTILATOR FOLLOWING CABG ON 6/4/96. RN NOTED PT'S BLOOD PRESSURE BEGINNING TO DROP AND FACE BEGAN TO TURN BLUE AND DUSKY. ABDOMEN INCREASED IN SIDE, CPR WAS STARTED. THE PT WAS AMBU-BAGGED AND HIS COLOR RETURNED. THE PHYSICIAN ORDERED THE VENTILATOR TO BE CHANGED OUT. CLINICAL ENGINEERING TEST REVEALED THE OPERATION TO BE SOMEWHAT ERRATIC WITH THE UNIT DELIVERING SPONTANEOUS BREATHS, TRIGGERED BY A SMALL LEAK IN THE CIRCUIT. THE CIRCUIT WAS TIGHTENED AND OPERATION RESUMED NORMALLY. IT WAS ALSO FOUND THAT THE TRANSDUCER WAS ZEROED WHICH COMBINED WITH A PEEP SETTING OF 5 CM H2O, GAVE A MEAN PRESSURE OF APPROX 23CM H2O. THE UNIT RECENTLY HAD A CALIBRATION AND FUNCTIONAL CHECK WITH 424 HRS OF OPERATION LOGGED. FOLLOWING INVESTIGATION IT WAS FELT THIS OCCURRENCE WAS RELATED TO USER ERROR.
TISSUE EXPANDER WAS IMPLANTED ON 11/29/95 AND EXPLANTED ON 1/18/96. EXPANDER WOULD NOT HOLD INFLATION. (IMPLANT STERILIZED AFTER EXPLANTATION).
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. POSSIBLE MICROMOVEMENT FROM TEMPORARY PROSTHESIS. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
MONITOR SHOWED HIGHER THAN ACTUAL SAO2 READING.
CATHETER INSERTED, BALLOON RUPTURED. CATHETER REMOVED, BALLOON NOT ATTACHED TO CATHETER.
PT WAS HYPOTENSIVE AND BRADYCARDIC AND DID NOT RESPOND TO ATROPINE. EXTERNAL PACEMAKER PLACED ON HIM AND SET FOR DEMAND CAPTURE. PT HAD AN UNDERLYING RHYTHM OF 35-40 BEATS PER MINUTE. ALTHOUGH THE DEMAND BUTTON WAS PRESSED SEVERAL TIMES. THERE WAS NO ACTIVITY ON THE PACER CASSETTE AND NO LIGHT WOULD GO ON. PT PLACED ON "NON-DEMAND" AND THE UNIT RESPONDED PACING OVER THE PT'S RHYTHM.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT IS A SMOKER. THI FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
TISSUE EXPANDER WAS IMPLANTED ON 10/5/96. BILATERAL DEFLATION OF TISSUE EXPANDER RIGHT BREAST NOTED BY SURGEON ON 4/8/96. RIGHT BREAST EXPANDER WAS REPLACED WITH PERMANENT BREAST PROSTHESIS ON 4/9/96.
TISSUE EXPANDER IN RIGHT BREAST WAS IMPLANTED ON 3/11/96. TISSUE EXPANDER WOULD NOT HOLD DEFLATION, EXPLANTED AND NEW TISSUE EXPANDER INSERTED ON 4/23/96.
A 4 WIRE 3.0 FR STONE BASKET FAILED TO CLOSE AND AT THE END OF THE BASKET CONTAINED TISSUE. BASKET SENT TO PATHOLOGY. A DOUBLE STENT WAS PLACED. THE MANAGEMENT OF THIS WILL INCLUDE LONG TERM STENTING.
FAILED ARTIFICIAL URINARY SPHINCTER. PT HAD TO RETURN TO SURGERY FOR REMOVAL OF SPHINCTER. SENT TO PATHOLOGY FOR IDENTIFICATION, SPHINCTER WAS LEAKING URINE.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNKNOWN. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT UNDERWENT L4-L5 LAMINECTOMY WITH L5-S1 DISCECTOMY FOR LUMBAR STENOSIS. NO SURGICAL COMPLICATIONS WERE DOCUMENTED. POST OPERATIVELY SHE HAD DROPS IN HER SO2. SHE HAD AWAKENED; HOWEVER, WHILE STILL ON THE VENT, SHE APPEARED TO BE RE-ANESTHETIZED. SHE WAS AMBUED FROM THE FLOW METER FOR ONE-HALF MIN, WITHOUT IMPROVEMENT. ANOTHER O2 TANK WAS UTILIZED AND PT SUCCESSFULLY AMBUED AND SUBSEQUENTLY PLACED ON 40% O2 BY FACE MASK. O2 SATURATION WAS 92-93%. THE PT'S POSTOPERATIVE COURSE WAS UNEVENTFUL AND SHE WAS DISCHARGED HOME ON 3/7/96.
RESIDENT WAS FOUND UNRESPONSIVE IN A PARTIALLY PRONE POSITION WITH LEGS OVER SIDE RAIL. HER HEAD WAS FACING THE LEFT SIDE WITH THE SOFT WAIST RESTRAINT ON HER RIGHT SHOULDER ACROSS HER BACK TO THE LEFT SIDE. PRIOR TO THE INCIDENT, THE BED WAS SET UP BY CO REP WITHOUT THE RESIDENT IN THE BED. THE STAFF EXPRESSED TO HIM THEIR CONCERN REGARDING THE HEIGHT OF THE BED WITH A STANDARD MATTRESS AND AN EXISTING THREE INCH OVERLAY ON THE MATTRESS. THE CO REP STATED "IT IS FINE." THE NURSING STAFF REMOVED THE ADD'L THREE INCH OVERLAY TO REDUCE THE HEIGHT OF THE BED. THE BED WAS TWO-AND-A-HALF TO THREE INCHES BELOW THE SIDE RAIL AFTER THE OVERLAY WAS REMOVED AND THE RESIDENT PLACED ON THE BED. THE HEIGHT OF THE BED REMAINED A CONCERN DUE TO THE RESIDENTS' CONDITION. THE CO ACCOUNT MANAGER CALLED THE DIRECTOR OF NURSING AT APPROX. 2:00 P.M. THAT SAME AFTERNOON TO SAY THAT SHE WAS COMING OUT TO CHECK THE BED SINCE SHE WAS NOT SURE THAT THE TECHNICIAN WHO INSTALLED THE BED WAS FAMILIAR WITH IT. THE FACILITY IS NOT AWARE SHE EVER FOLLOWED UP ON THIS CONCERN. AFTER THE INCIDENT, WE WERE RPTR WAS MADE AWARE THAT A TWO INCH FILLER PAD WAS AVAILABLE TO USE IN PLACE OF THE STANDARD MATTRESS.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. POSSIBLE OVERHEATING OF BONE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
APPROX ONE WEEK PRIOR TO SURGERY DATE OF 3/7/96, PT NOTED "SUDDEN LOSS OF RIGHT BREAST VOLUME." PT AND PHYSICIAN ELECTED FOR REMOVAL AND REPLACEMENT OF SALINE IMPLANTS. UPON REMOVAL OF RIGHT IMPLANT, IT WAS NOTED TO BE DEFLATED. NO GROSS CUTS OR HOLES APPARENT.
RESIDENT WAS FOUND UNRESPONSIVE IN A PARTIALLY PRONE POSITION WITH LEGS OVER SIDE RAIL. HER HEAD WAS FACING THE LEFT SIDE WITH THE SOFT WAIST RESTRAINT ON HER RIGHT SHOULDER ACROSS HER BACK TO THE LEFT SIDE. PRIOR TO THE INCIDENT, THE BED WAS SET UP BY CO REP WITHOUT THE RESIDENT IN THE BED. THE STAFF EXPRESSED TO HIM THEIR CONCERN REGARDING THE HEIGHT OF THE BED WITH A STANDARD MATTRESS AND AN EXISTING THREE INCH OVERLAY ON THE MATTRESS. THE CO REP STATED "IT IS FINE." THE NURSING STAFF REMOVED THE ADD'L THREE INCH OVERLAY TO REDUCE THE HEIGHT OF THE BED. THE BED WAS TWO-AND-A-HALF TO THREE INCHES BELOW THE SIDE RAIL AFTER THE OVERLAY WAS REMOVED AND THE RESIDENT PLACED ON THE BED. THE HEIGHT OF THE BED REMAINED A CONCERN DUE TO THE RESIDENT'S CONDITION. THE CO ACCOUNT MANAGER CALLED THE DIRECTOR OF NURSING AT APPROX. 2:00 P.M. THAT SAME AFTERNOON TO SAY THAT SHE WAS COMING OUT TO CHECK THE BED SINCE SHE WAS NOT SURE THAT THE TECHNICIAN WHO INSTALLED THE BED WAS FAMILIAR WITH IT. THE FACILITY IS NOT AWARE SHE EVER FOLLOWED UP ON THIS CONCERN. AFTER THE INCIDENT, RPTR WAS  MADE AWARE THAT A TWO INCH FILLER PAD WAS AVAILABLE TO USE IN PLACE OF THE STANDARD MATTRESS.
PT HAD BILATERAL SILICONE IMPLANTS IN 1980 IN ANOTHER INSTITUTION. RECENT MAMMOGRAPHY SUGGESTS POSSIBLE IMPLANT RUPTURE. PT ELECTED TO HAVE REMOVAL OF SILICONE IMPLANTS. UPON SURGICAL INCISION, BOTH IMPLANTS WERE NOTED TO BE RUPTURED WITH SILICONE MATERIAL THROUGHOUT THE AREA.
PT HAD ORIGINAL TOTAL JOINT RECONSTRUCTION DONE ON 1/15/90. NORMAL RECOVERY UNTIL 8/11/95 WHEN REVISION TOTAL JOINT DONE. ALL PLASTIC COMPONENTS WERE CHANGED ON THAT DATE. PT AGAIN PRESENTED TO THE PHYSICIAN'S OFFICE POST REVISION WITH COMPLAINT OF PAIN AND SWELLING IN OPERATIVE KNEE. ARTHROSCOPIC PROCEDURE DONE ON 2/96 SHOWED "FAILING TOTAL KNEE DUE TO POLY-WEAR." A PORTION OF THE TIBIAL INSERT WAS REMOVED DURING THE PROCEDURE.
ACCORDING TO THE DISCHARGE SUMMARY, PT HAD THE IPP PLACED IN 1991 AND HAD HAD NO PROBLEMS UNTIL RECENTLY. FOLLOWING A FALL, HE HAD BEEN HAVING SOME PAIN IN PENIS AND NOW IS HAVING PORTRUSION OF THE CYLINDERS BENEATH THE GLANDS. PT WAS ADMITTED FOR REMOVAL OF IPP.
PT HAD LEFT MASTECTOMY IN 1988 AND IN 5/19/89 HAD A SILICONE BREAST IMPLANT. SHE HAD A NORMAL IMMEDIATE POST-OPERATIVE RECOVERY. SHE RECENTLY PRESENTED TO THE PHYSICIAN'S OFFICE WITH COMPLAINTS OF CAPSULAR CONTRACTURE AND SLIGHT DISPLACEMENT OF PROSTHESIS. ALSO, HER MENTAL ANGUISH REGARDING THIS IMPLANT HAS INCREASED WITH RECENT MEDIA COVERAGE OF SILICONE BREAST IMPLANTS. UPON REMOVAL OF THE IMPLANT IT WAS NOTED TO BE INTACT.
ACCORDING TO THE DISCHARGE SUMMARY, PT SLOWLY BEGAN DEVELOPING PAIN, INCREASING PROBLEMS ABOUT HER LEFT HIP, AND THE X-RAYS SHOWED SIGNS OF AVASCULAR NECROSIS. FEMORAL HEAD WITH NAIL PENETRATING THROUGH THE REMAINING PORTION OF THE HEAD. PT PHYSICAL FINDINGS ON ADMISSION SHOWED PAIN WITH ANY ATTEMPTED RANGE OF MOTION WITH HER HIP AND SHORTENING. X-RAYS REVEALED AVASCULAR NECROSIS WITH DEGENERATIVE CHANGES ABOUT THE LEFT HIP. ADMITTED FOR REVISION.
INVESTIGATION CONDUCTED. DR CITES SURGICAL TRAUMA AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT HAD HAD THE LEFT SUBCLAVIAN IV SYSTEM FOR A YEAR AND HAD DEVELOPED THROMBOSIS OF THE LEFT SUBCLAVIAN VEIN WITH LARGE SWELLING OF THE LEFT ARM. THE PHYSICIAN REMOVED THE LEFT SUBCLAVIAN IV SYSTEM AND REPLACED IT WITH A RIGHT SUBCLAVIAN CATHETER.
A 57-YR-OLD WHITE MALE WHO IS PARAPLEGIC PRESENTED TO ER AWAKE BUT LETHARGIC. PHYSICIAN ORDERED A FOLEY CATHETER TO BE PUT IN. A 16F 5CC FOLEY CATHETER TRAY WAS OBTAINED, PT PREPPED AND CATHETER BALLOON WAS CHECKED PRIOR TO INSERTION BY INSTILLING A FEW CC'S OF SALINE AND WITHDRAWING. THE BALLOON APPEARED TO FUNCTION PROPERLY. THE CATHETER WAS INSERTED INTO THE PT ALMOST THE ENTIRE LENGTH OF THE CATHETER. NO URINE RETURN, SO 2 CC'S OF SALINE WAS INJECTED INTO THE BALLOON PORT. THE CATHETER COULD NOT BE ADVANCED OR REMOVED WITHOUT MUCH FRICTION. THE PHYSICIAN WAS CALLED AND COULD NOT GET THE BALLOON DEFLATED. THE BALLOON PORT WAS CUT OFF WITH NO RESULTS AND THEN THE ENTIRE CATHETER WAS CUT IN TWO WITH NO DEFLATION OF THE BALLOON. THE PHYSICIAN THEN REMOVED THE CATHETER WITH THE BALLOON INFLATED. MINOR BLEEDING RESULTED.
INVESTIGATION CONDUCTED. DR CITES BONE QUANTITY INSUFFICIENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT HAD TOTAL KNEES DONE IN 1990. STILL IN PLACE FROM THAT OPERATION. ON THE LEFT KNEE ARE THE STEMMED TIBIAL PLATE AND FEMORAL COMPONENT. OTHER COMPONENTS WERE REMOVED AFTER PT HAD MULTIPLE DISLOCATION EPISODES AND SUBLUXATION EPISODES. PT UNDERWENT REVISION ARTHROPLASTY WITH CONVERSION OF HIS TIBIAL TRAY TO A LARGER SIZE FOR BETTER SOFT TISSUE BALANCING WHICH STOPPED THE DISLOCATIONS. IN ADDITION, HIS LEFT PATELLAR COMPONENT WAS LOOSE, SO IT WAS REMOVED.
ACCORDING TO THE H&P, A CENTRAL VENOUS CATHETER, WHICH HAD BEEN PLACED IN THE ER, BECAME DISLODGED AND THE CATHETER ACTUALLY MIGRATED DOWN INTO THE SUPERIOR VENA CAVA AND EVENTUALLY DOWN INTO THE HEART WHERE THE SUPERIOR PORTION WAS ABOVE THE ATRIOVENTRICULAR VALVE. PRIOR TO ITS MIGRATION, A SURGEON SAW THE PT AND TRIED TO REMOVE IT THROUGH THE SUBCLAVIAN VEIN UNSUCCESSFULLY. AT THAT POINT, A CARDIOLOGIST WAS CONSULTED AND A HEART CATHETERIZATION WAS PERFORMED WITH SNARING OF THE CATHETER AND SUBSEQUENT REMOVAL.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY INSUFFICIENT AND INFECTIONAS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT  FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT WAS BEING TRANSPORTED ON GURNEY-SMALL, AMBULANCE TYPE-FROM MRI. GURNEY WAS PARKED WITH PT AWAITING TRANSPORT BACK TO ROOM. TECH BEGAN MOVING PT, PT APPARENTLY WAS STARTLED BY THE MOVEMENT AND TURNED TO HER RIGHT, THE GURNEY TIPPED, PT SLID TO THE FLOOR STRIKING HER HEAD AND SHOULDER ON THE FLOOR. TECH GRABBED HER LEGS AND BROKE THE FALL. PT WAS LAYING ON A SLIDER BOARD WITH TWO STRAPS SECURED OVER HER LOWER BODICE AND LEGS. THE SLIDER BOARD WAS WIDER THAN THE GURNEY WHICH PRECLUDED BOTH SIDE RAILS FROM BEING UP. THE LEFT RAIL WAS UP.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT FROM TEMPORARY PROSTHESIS,  BONE QUALITY/QUANTITY INSUFFICIENT AND INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR OF LT KNEE, WHILE DRILLING THE PIN PASSER THROUGH THE FEMUR, THE TROCAR TIP OF THE PIN BROKE OFF. THE TIP BECAME LODGED IN SOFT TISSUE AT PIN'S EXIT. FLOUROSCOPY WAS REQUIRED TO LOCATE THE TIP AND EXTRACTION WAS PERFORMED THROUGH AN ADD'L WOUND.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT CONSUMES ALCOHOL. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INTRA-AORTIC BALLOON (IAB) CATHETER WAS INSERTED POST CORONARY ARTERY BYPASS SURGERY FOR DECREASED BLOOD PRESSURE AND POOR CARDIAC OUTPUT POST-OP. IAB CATHETER APPEARED NOT TO UNWRAP PROPERLY RESULTING IN INABILITY TO AUGMENT PT.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNKOWN. THIS FILE IS CLOSED.  THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
CLIP APPLIER SHOT THE CLIPS OUT AND DID NOT CLOSE THEM, NO PINCHING/CLOSING ACTION AT ALL. NO INJURY TO PT. UNABLE TO RETURN DEFECTIVE DEVICE TO MFR AS IT HAD TO BE DISCARDED. EXPIRATION DATE 5/01.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL LOADING OF IMPLANT ANDPOSSIBLE SURGICAL TRAUMA AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNKNOWN. PT IS A BRUXER AND CONSUMES ALCOHOL. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING ATA FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
ON 4/9/96, CATARACT EXTRACTOR FAILED TO GENERATE ADEQUATE VACCUUM DURING A CATARACT PROCEDURE. THE UNIT EXHIBITED PROBLEMS WITH VACUUM, SUCTION AND COULD NOT BE RELIED ON UPON TO WORK CONSISTENTLY. ON 4/10/96, THIS CATARACT EXTRACTOR UNIT WAS TAKEN OUT OF SERVICE. ON 4/12/96, CO FIELD SERVICE ENGINEER PERFORMED A SCHEDULED PREVENTIVE MAINTENANCE SERVICE THE UNIT AND RETURNED THE UNIT TO SERVICE. ON 4/30/96, IN SERVICE TRAINING WAS CONDUCTED BY THE MFR. AS A RESULT, THE GROUP FORUM POTENTIAL PROBLEMS WERE DISCUSSED. THE ISSUE OF REPLACING THE HANDPIECE WAS AT HAND AND THUS A QUESTIONABLE LINK AS TO THE LOSS, CAUSE STILL UNKNOWN? ON 5/2/96, THE OLD HANDPIECE WAS TURNED-IN AND TWO NEW HANDPIECES WERE PURCHASED AND RECEIVED. ON 5/30/96, A SETUP PREPARATION LIST WAS POSTED ON OR NEAR THE CATARACT EXTRACTOR UNIT.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. POSSIBLE SURGICAL TRAUMA. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT FROM TEMPORAY PROSTHESIS, BONE QUALITY INSUFFICIENT AND PT HAS THRUSTING TONGUE HABITS AND DIMINISHED ORAL HYGIENE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL LOADING AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
BI-LATERAL BREAST MASTECTOMIES IN 12/94. HAD BI-LATERAL BREAST RECONSTRUCTION IN 1976. NO MEDICAL PROBLEMS SURFACED UNTIL 1990: ASTHMA, GRAVES DISEASE; CTD, FIBROMYALGIA, GASTROINTESTINAL PROBLEMS, NEUROLOGICAL-COGNITIVE IMPAIRMENT, BALANCE DISTURBANCE, IBS, OTHER AUTOIMMUNE PROBLEMS, SJOGREN'S SYNDROME.
PT FOUND THAT DEVICE WAS SPLITTING LEAKING AT CONNECTIONS. EXPIRATION DATE 8/2000.
ADMITTED TO SSU FOR ANTIOPLASTY AND STENT PLACEMENT. HAD SUCCESSFUL AND UNEVENTFUL DILATION OF RIGHT ILIAC ARTERY WITH PLACEMENT OF VASCULAR STENT. SURING DILATATION AND STENT PLACEMENT IN LEFT ILIAC ARTERY, THE ARTERY WAS DAMAGED RESULTING IN INTERNAL BLEEDING. PT TAKEN TO SURGERY TO CORRECT DAMAGE TO LEFT ILIAC ARTERY.
DIFFICULTY REMOVING IABP DUE TO RESISTANCE. AFTER REMOVAL THE BALLOON WAS FOUND TO HAVE VERY DARK COFFEE-GROUND MATERIAL WITHIN BALLOON ITSELF. THE BALLOON WAS REMOVED WITH ANOTHER DEVICE WITHOUT ANY EXCESSIVE BLEEDING/HEMATOMA.
CUSHION SEALED MANUAL RESUSCITATION MESH DEFLATES OVER TIME WHICH RENDERS MASK INOPERABLE IF NOT REINFLATED. DESIGN OF MASK WITH PLASTIC PLUG INSTEAD OF A ONE WAY VALVE COULD HAVE POTENTIAL FOR ADVERSE EVENT AT TIME OF A RESUSCITATION EMERGENCY. MFR RECOMMENDATION IS TO REINFLATE MASK PERIODICALLY. ALSO WHEN MASK DEFLATES, THE CUSHION SEAL MATERIAL BREAKS DOWN INTO A POWDERY SUBSTANCE AND RENDERS THE MASK INOPERABLE AND INCAPABLE OF REINFLATION.
PT ADMITTED FOR ELECTIVE DIAGNOSTIC LAPAROSCOPY. DURING CLOSURE OF THE INCISION THE TIP OF THE NEEDLE WAS BROKEN, APPROX. 2 OR 3 MM. ALL ATTEMPTS MADE TO LOCATE NEEDLE WERE FUTILE, INCLUDING MAGNETIC RETRIEVER AND ABDOMINAL X-RAYS OF PT. NO METALLIC FOREIGN BODY WAS IDENTIFIED.
DURING A MICRO CO2 LASER CONIZATION OF THE CERVIX, DIRECTED COLPOSCOPY AND ECC, AFTER USING THE 12 INCH HOOK INSTRUMENT TO RETRACT CERVICAL TISSUE, WHEN THE INSTRUMENT WAS HANDED BACK TO THE SCRUB TECHNICIAN IT WAS NOTED THAT THAT THE TIP OF THE GRASPER  WAS MISSING. THE PIECE MEASURED APPROX. 1 CM IN LENGTH. THE SURGEON WAS NOTIFIED AND AN X-RAY OF THE PELVIS WAS ORDERED WHICH WAS NEGATIVE FOR A FOREIGN OBJECT. THE SURGEON ALSO EXAMINED THE VAGINA AND THE ENDOCERVIX AND SO THE BED LINENS AND THE TIP OF THE INSTRUMENT WAS NOT FOUND. HOWEVER, X-RAYS WERE NEGATIVE FOR A FOREIGN OBJECT. PT WAS DISCHARGED HOME AND IS TO BE FOLLOWED ON AN OUTPATIENT BASIS.
10/3/93 DIAGNOSED WITH BREAST CANCER IN LEFT BREAST. 10/8/93 MODIFIED RADICAL MASTECTOMY LEFT BREAST. 11/2/93 CATHETER PLACED FOR CHEMOTHERAPY TREATMENTS. 11/16/93 CHEMOTHERAPY TREATMENTS BEGAN. 8/16/94 MASS DISCOVERED IN RIGHT BREAST. 8/30/94 SUBCUTANEOUS MASTECTOMY RIGHT BREAST. 11/4/94 BREAST RECONSTRUCTION BEGAN WITH TISSUE EXPANDERS PLACED IN LEFT AND RIGHT BREAST. NO PROBLEMS. 7/14/95 TISSUE EXPANDERS REMOVED AND REPLACED WITH PERMANENT PROSTHESIS (MAMMARY IMPLANTS) IN LEFT AND RIGHT BREAST. 8/11/95 CHEMOTHERAPY TREATMENTS ENDED. 10/13/95 SURGERY FOR REVISION OF RIGHT BREAST RECONSTRUCTION (TROUBLE STARTED) AND NIPPLE/AREOLA RECONSTRUCTION, LEFT BREAST. (NIPPLE RECONSTRUCTION DID NOT TAKE). 10/31/95 EMERGENCY SURGERY POST OPERATIVE COMPLICATIONS, SURGERY FOR EVACUATION OF POST SEROMA AND PLACEMENT OF DRAIN, RIGHT BREAST. 2/27/96 ONCOLOGIST EXAMINED WOUND ON RIGHT BREAST. 3/15/96 TOOK PICTURES OF CHRONIC WOUND THAT HAD BEEN PRESENT SINCE PERMANENT IMPLANT HAD BEEN PLACED IN RIGHT BREAST. 5/28/96 DR EXAMINED RIGHT BREAST WOUND AND SUGGESTED IMPLANTS BE REMOVED. IT WAS INFECTED. 6/17/96 WENT TO DR CONCERNED ABOUT CHRONIC RIGHT BREAST WOUND AND PAIN. A LUMP WAS DISCOVERED IN SCAR LINE OF LEFT BREAST AT THIS VISIT ALSO. 6/17/96 SECOND OPINION, "IMPLANT MUST COME OUT OF RIGHT BREAST." 6/25/96 SURGERY FOR BREAST TISSUE/TUMOR BIOPSY LEFT BREAST SCAR LINE. AT THIS TIME AN ATTEMPT WAS MADE TO CORRECT THE CHRONIC WOUND ON THE RIGHT BREAST. TISSUE WAS REMOVED IN THE AREA AND STITCHED WITH NON-REMOVABLE TYPE STITCHES AND PAPER TAPE WAS USED TO CLOSE. 7/12/96 SAW DR FOR PAIN, FEVER, SWELLING AND REDNESS. HE PRESCRIBED PAIN MEDICATION AND ANTIBIOTICS AND STAPLED THE OPENING BACK TOGETHER IN RIGHT BREAST. 7/13/96 WOKE IN MORNING AND BEDSHEETS WERE DRENCHED IN A LARGE AREA WITH A LIQUID SUBSTANCE. SEVERE PAIN WAS PRESENT. CALLED DR AND HE SUGGESTED REST, TAPE WOUND BACK TOGETHER AND COME INTO HIS OFFICE ON THE FOLLOWING MONDAY. 7/15/96 SAW DR, HE STATED, IMPLANT MUST COME OUT OF RIGHT BREAST. 7/16/96 SURGERY WAS PERFORMED IN DR'S OFFICE AND RIGHT BREAST IMPLANT WAS REMOVED. 7/16/96 PICTURES JUST BEFORE IMPLANT WAS REMOVED, THEY WERE TAKEN ON THE MORNING OF SURGERY. 7/24/96 REGULAR VISIT WITH DR AND HE SUGGESTED PT SEE ANOTHER PLASTIC SURGEON. 8/6/96 AS OF THIS DATE PT STILL HAS A MAMMARY IMPLANT IN LEFT BREAST AND CONTINUES TO HAVE PAIN AND DISCOMFORT IN BOTH BREASTS, ARMS, NECK HANDS AND SHOULDERS. FATIGUE ALSO ACCOMPANIES CONDITION. AS OF THIS DATE, RPTR HAS A PENDING APPOINTMENT WITH A NEW PLASTIC SURGEON. (*)
PT HAD A PORT IMPLANTED ON 5/22/96. APPROX. TWO HOURS AFTER INITIAL X-RAY, DIFFICULTY ACCESSING PORT NOTED. RADIOLOGIC FILM TAKEN SHOWED KINKING OR COMPRESSION OF THE LEFT SUBCLAVIAN VENOUS CATHETER. PT TAKEN BACK TO SURGERY FOR REMOVAL OF PORT. UPON INITIAL INSERTION OF THE PORT PLACEMENT WAS APPROPRIATE PER C-ARM AND CATHETER FLUSHED FREELY.
84 YR OLD PRESENTED FOR PHACO EMULSIFICATION INTRAOCULAR LENS RIGHT EYE. DEVICE WAS OBTAINED IN PREPARATION FOR THE PROCEDURE. THE BOX CONTAINS BOTH THE DEVICE AND ANOTHER DEVICE. THE NEEDLE IN THE BOX FELL ON THE FLOOR AND WAS DISCARDED. A STERILE 27 GAUGE CANNULA, BLUNT TIP WAS OBTAINED TO REPLACE IT. (THIS WAS THE CANNULA DESCRIPTION ON THE CO'S DEVICE'S BOX. THE LABELING ON THE DEVICE BOX DID NOT INDICATE TO USE ONLY ITS BRAND CANNULA.) THE REPLACEMENT CANNULA WAS ANOTHER CO'S PRODUCT. THE OR STAFF CONNECTED THE CANNULA TO THE SYRINGE AND EXPELLED ANY AIR PRESENT. SUBSEQUENTLY, WHEN THE SURGEON WENT TO USE THE SYRINGE, AS HE STARTED TO PUSH ON THE PLUNGER THE CANNULA SHOT OFF AND STRUCK THE PT'S EYE CAUSING A SUBLUXATION OF THE CATARACT. (THE CATARACT WENT BEHIND THE CAPSULE OF THE EYE.) THE SURGEON WAS UNABLE TO RETRIEVE IT. THE PT HAD TO BE TRANSFERRED TO ANOTHER HOSP FOR REMOVAL OF THE CATARACT. EXTENT OF INJURIES, IF ANY, ARE UNKNOWN.
EMPLOYEE'S CHEEKS, FOREHEAD, AND CHIN BECAME VERY HOT AND RED, WHILE BEING FIT-TESTED. REDNESS CONTINUED FOR SEVERAL HRS AFTER RESPIRATOR WAS REMOVED.
WHILE INFLATING AT HIGH ATMOSPHERE (10 ATM) POST STENT DEPLOYMENT BALLOON WOULD NOT DEFLATE. BALLOON FINALLY DEFLATED AFTER ATTACHED TO POWER INJECTOR AND ASPIRATED.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT FROM TEMPORARY PROSTHESIS AND POOR ORAL HYGIENE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
IV PUMP KEPT ALARMING "AIR IN LINE" WHEN THERE WAS NO AIR IN THE IV TUBING.
WHILE APPLYING A CLIP THE APPLIER HANDLE BROKE OFF. ANOTHER INSTRUMENT WAS USED WITHOUT INCIDENT. NO NEGATIVE OUTCOME OF NOTE.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY INSUFFICIENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
STAPLER USED ON VAGINAL CUFF. DELIVERED ONLY ONE ROW OF STAPLES. CUFF CAME APART AND WAS RE-APPROXIMATED USING. SUTURES, STAPLES WERE REMOVED FROM PT.
NASOGASTRIC TUBE THAT WAS PLACED TWO DAYS EARLIER HAD NO DRAINAGE. MD INFORMED AND TUBE IMMEDIATELY REMOVED AND FOUND TO HAVE NO DRAINAGE HOLES. PT SUFFERED NO SEQUELAE.
LAPAROSCOPIC RING APPLCIATOR MALFUNCTIONED DURING PROCEDURE AND CLIP LOCKED. HAD TO UTILIZE MORE DESTRUCTIVE METHOD; CALLED COMPLETE PROCEDURE.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNKNOWN. PT HAS OSTEOPEROSIS.THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
EYE MICROSCOPE MALFUNCTIONED DURING CATARACT CASE--ELECTRICAL PROBLEM IN EQUIPMENT (FUSE). PT NEEDS TO HAVE A RETURN TO SURGERY AT A FUTURE DATE.
REACTION TO LATEX GLOVES ON MORE THAN ONE OCCASION. EVENT ON 6/27/96 REQUIRED TREATMENT IN ER. RASH AND SEVERE ITCHING FOLLOWING THE WEARING OF LATEX GLOVES. RASH ON HANDS ARMS, ABDOMEN, FACIAL FLUSHING, EDEMA OF HANDS, DIFFICULTY BREATHING. "GLOVE TEST - POSITIVE, SCRATCH TEST - NEGATIVE, INTRADERMAL TEST - QUITE POSITIVE AT A 4+ LEVEL (MAXIMUM REACTION THAT COULD BE MEASURED.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT FROM TEMPORARY PROSTHESIS AND BONE QUALITY INSUFFICIENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
ADDITIONAL INFO RECEIVED FROM MFR ON 10/02/1998: RESULTS OF INVESTIGATION: RETURNED SAMPLE CONTAINED PACKAGING FOR REPORTED CC2308, SET SUBMITTED WAS  A MODEL CC2204. NOTED THAT RETURNED SET HAS 2 INJECTION SITES AS PER A CC204, MODEL CC2308 WOULD HAVE THREE INJECTION SITES. REVIEW OF QA RECORDS, MODEL CC2308, LOT SEP94T04, INDICATES THE ORIGINAL LOT SIZE TO BE 240 CASES WITH A RELEASE DATE OF 10/28/1994. THERE ARE NO OTHER REPORTED CONCERNS FOR THISLOT,MANUFACTURING SITE INFO INDICATES GREATER THAN 30 DAY PERIOD BETWEEN BUILD DATES FOR BOTH PRODUCTS.
THE PT HAD A CATHETER INSERTED ON 11/30/95 FOR CHEMOTHERAPY INFUSIONS. ON 3/12/96, THE PT WAS SENT TO THE HOSP FOR A PORT-A-CATHOGRAM WHEN THE STAFF HAD DIFFICULTY GETTING A BLOOD RETURN. THIS STUDY SHOWED THAT THE CATHETER HAD SEPARATED PROXIMALLY AND THE FRAGMENTED PORTION EXTENDED FROM THE RIGHT ATRIUM TO THE RIGHT VENTRICLE. THE CATHETER WAS RETRIEVED WITH A SNARE VIA THE RIGHT COMMON FEMORAL VEIN. THE PORT WAS REMOVED SEVERAL DAYS LATER FROM THE RIGHT SIDE OF THE PT'S CHEST. THERE WAS NO INJURY FROM THESE PROCEDURES FOR RETRIEVAL.
BLOOD GAS REPORT VALVES PRINTED ARE NOT THE SAME AS THOSE DISPLAYED ON BLOOD GAS ANALYZER AND ON DATA MANAGEMENT SYSTEM. APPEARS TO BE A SOFTWARE PROBLEM AT THE TIME REPORTS ARE PRINTED.
THE PT WAS ADMITTED TO THE HOSP FOR RETRIEVAL IN RADIOLOGY'S SPECIAL PROCEDURES DEPARTMENT, OF A PORTION OF CATHETER. THE CATHETER WAS SUCCESSFULLY RETRIEVED WITHOUT PT INJURY.
PHYSICIAN HAD A PROBLEM INFUSING THE PT'S CHEMOTHERAPY AND SENT THE PT TO  THE SPECIAL PROCEDURES DEPARTMENT IN RADIOLOGY FOR RETRIEVAL OF A CATHETER FRAGMENT FROM THE SUPERIOR VENA CAVA LEFT INNOMINATE VEIN. THIS WAS SUCCESSFULLY ACCOMPLISHED.
DURING LAPAROSCOPIC CHOLECYSTECTOMY, HANDPIECE LEAKED AND WOULD NOT COAGULATE PROPERLY. ASSUMED THAT O-RINGS WERE BAD. NO INJURY TO PT. UNABLE TO RETURN DEFECTIVE DEVICE TO MFR FOR EVALUATION AS IT HAD TO BE DISCARDED.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY/QUANTITY INSUFFICIENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE PT WAS ADMITTED TO THE SPECIAL PROCEDURES DEPARTMENT OF RADIOLOGY FOR RETRIEVAL OF A PORTION OF A CATHETER IN THE PT'S ATRIUM. THE CATHETER WAS SUCCESSFULLY RETRIEVED WITHOUT PT INJURY.
THE PT WAS SENT TO THE SPECIAL PROCEDURES DEPARTMENT IN RADIOLOGY FOR RETRIEVAL OF A PORTION OF A PORT CATHETER. THE PORTION WAS SUCCESSFULLY RETRIEVED WITHOUT INJURY TO THE PT.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY INSUFFICIENT AS CAUSE FOR FAILURE. PT IS A BRUXER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
REACTION TO LATEX GLOVES ON MORE THAN ONE OCCASION. EVENT ON 6/27/96 REQUIRED TREATMENT IN ER. RASH WITH SEVERE ITCHING FOLLOWING THE WEARING OF LATEX GLOVES. RASH ON HANDS, ARMS, ABDOMEN, FACIAL FLUSHING, EDEMA OF HANDS, DIFFICULTY BREATHING. SENT TO DERMATOLOGIST/ALLERGIST, "GLOVE TEST" POSITIVE, SCRATCH TEST NEGATIVE, INTRADERMAL TEST QUITE POSITIVE AT A 4+ LEVEL (MAXIMUM REACTION THAT COULD BE MEASURED). ADD'L EVENT DATE 7/9/96.
RIGHT POPLITEAL EMBOLUS APPROX 2 WEEKS FOLLOWING CORONARY ANGIOGRAM VIA RIGHT FEMORAL PUNCTURE. ARTERIAL PUNCTURE SEALED WITH PRODUCT. AUG 7/29 SHOWED NO APPARENT SOURCE FOR EMBOLUS. TEE 8/1 NO CARDIAC SOURCE FOR EMBOLUS.
STARTED WITH SEVERE CHEST PAINS, CHRONIC BLADDER PROBLEMS IN 1984. ARDS IN 1987, WAS HOSPITALIZED FOR 6 WEEKS ON RESPIRATOR. SINCE RPTR HAS BEEN DIAGNOSED WITH RAYNAUD'S DISEASE, ATYPICAL CONNECTIVE TISSUE AND FIBROMYALGIA. SHE DOESN'T SLEEP, AND ALWAYS IS IN PAIN. HAD A "BAD MAMMOGRAM" IN 1966 WHICH 3 DRS SAID WAS A TEAR IN IMPLANT. ALSO SKIN PROBLEMS IN 1996.
CUSTOMER RETURNED A BASAL THERMOMETER WHICH HAD BEEN RECEIVED BROKEN. PHARMACY REORDERED TWO (2) AND ONE CAME IN BROKEN, THE OTHER WAS NOT. UPON FURTHER INSPECTION OF NON-BROKEN THERMOMETER, IT WAS NOTICED THAT THEY ARE VERY DIFFICULT TO REMOVE FROM PACKAGING AND COULD BREAK ALSO IN JUST TRYING TO REMOVE FROM ITS HOLDER.
ON 7/28/96, AN INFUSION OF FENTANYL WAS BEING ADMINISTERED VIA AN EPIDURAL INFUSION PUMP. THE PUMP WAS LOADED WITH A NEW BAG AT 7:00 AM AND PROGRAMMED TO INFUSE AT 10CC/HR. ON 7/29/96 AT 4:15 AM, THE PUMP ALARMED "BAG EMPTY." WHEN THE PUMP WAS OPENED, THE BAG INSIDE WAS COMPLETELY FULL AND THE PT HAD NOT RECEIVED ANY MEDICATION. THE PT HAD RECEIVED 4 DOSES OF ATIVAN FOR AGITATION/RESTLESSNESS DURING THE TIME THAT THE MEDICATION HAD NOT INFUSED. THERE IS NO ALARM MECHANISM BUILT INTO THE PUMP TO INDICATE THE MEDICATION IS NOT INFUSING.
CO IS EXPERIENCING UNUSUALLY LOW PLATELET LEVELS FOLLOWING CARDIOPULMONARY BYPASS. THE RESULT OF THIS HAS BEEN BLEEDING COMPLICATION IN THE POST-OP TIME FRAME, REQUIRING LARGE PLATELET TRANSFUSION TO PT.
INITIAL SYMPTOMS WERE RESPIRATORY BUT DIAGNOSIS NOT MADE FOR OVER 1 YEAR. PHYSICIAN THOUGHT IT WAS NON-OCCUPATIONAL (FALL '94 THROUGH 1/96). RESPIRATORY PROBLEMS WORSENED AND LATER BODY RASH APPEARED. 12/95 LATEX RAST TEST - TOTAL RESULTS 1/96. 1/96 - HISTAMINE RELEASE BLOOD TESTS.
ONE JAW OF PAIR OF INDEPENDENT JAWS CLOSED IN BY ABOUT 2CM WITHOUT ANY INDICATION IN THE READOUT OR THE RECORD VERIFY. A SET SCREW THAT COUPLED THE JAW MOTION TO A VARIABLE RESISTOR APPEARS TO HAVE COME OUT. THE RADIATION THERAPIST NOTICED AN INCONSISTENCY IN THE APPEARANCE OF THE SET-UP FIELD AND THE READOUT AND ALL TREATMENTS WERE STOPPED UNTIL THE SYSTEM WAS REPAIRED AND SVC PERSON REPAIRED THE PROBLEM PROMPTLY. SET SCREW HAD LOCKED OUT AND COUPLE TO JAWS. EXTRA SET SCREWS WERE INSTALLED. A SVC REP ARRIVED ON SITE WITHIN SEVERAL HRS OF BEING CALLED AND REVIEWED THE PROBLEM THE PHYSICIST CONFIRMED THE VALIDITY OF THE READOUT AND THE RADIATION FIELD, LIGHT FIELD CONGRUENCE.
GUIDE WIRE .014 WAS POSITIONED IN THE LEFT ANTERIOR DESCENDING CORONARY WITHOUT DIFFICULTY. A DILATOR WAS INSERTED AND 2 DILATIONS PERFORMED. FLUSH INJECTIONS REVEALED AN IMPROVED ARTERY, WITH SIGNIFICANT RESIDUAL STENOSIS AND POSSIBLE SMALL DISSECTION. THE 2.75 DILATOR WAS REMOVED AND REPLACED WITH A 3.0 DILATION CATHETER. DILATION WAS PERFORMED WITH THE GUIDE WIRE PULLED BACK AND REPLACED AFTER DEFLATION. DUE TO THE CONCERN OF A DISSECTION IN AN AREA OF A SEVERE BEND IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THE PT WAS PREPARED FOR A STENT IMPLANTATION. THE 3.0 DILATOR WAS WITHDRAWN USING THE CO PRODUCT AND A 3.0 BALLOON-EXPANDABLE STENT WAS PLACED AND INFLATED WITH GOOD EXPANSION. THE BALLOON WAS WITHDRAWN WITH THE CO DEVICE IN PLACE. A 3.0 POST DILATION BALLOON CATHETER WAS INTRODUCED WITH THE CO DEVICE. FLUOROSCOPY WAS PERFORMED DURING THE ADVANCEMENT OF THE BALLOON NOTED THAT THE GUIDE WIRE ADVANCED SIGNIFICANTLY MORE INTERIORLY THAN IT HAD BEEN, DESPITE THE FACT THAT THE CO DEVICE WAS IN GOOD POSITION IN THE PROXIMAL SEGMENT OF THE WIRE. THE BALLOON WAS THEN WITHDRAWN OUTSIDE THE CO DEVICE, AND THE GUIDE WIRE WAS WITHDRAWN ALONG WITH IT. THIS WAS ATTEMPTED A SECOND TIME UNDER FLUOROSCOPY AND IT WAS NOTED THAT WHEN THE BALLOON WAS ADVANCED INSIDE THE CO DEVICE, THE GUIDE WIRE ADVANCED INTERIORLY. A SECOND DEVICE WAS PLACED OVER THE WIRE AND THE DILATOR WAS ADVANCED USING THE SECOND DEVICE WITHOUT DIFFICULTY. THE GUIDE WIRE WAS REMOVED AND REPEAT LEFT CORONARY ATERIOGRAMS REVEALED A PERSISTENTLY GOOD RESULT WITH NO EVIDENCE OF SLOW FLOW OR ANY STAINING OF THE MYOCARDIUM DURING THE LEFT CORONARY INJECTIONS. APPROX 2 HRS POST PROCEDURE THE PT COMPLAINED OF SOME MILD CHEST DISCOMFORT AND NAUSEA WITH HYPOTENSION. A STAT 2D ECHOCARDIOGRAM SHOWED A LARGE ANTERIOR PERICARDIAL EFFUSION. A PERICARDIAL CENTESIS WAS PERFORMED BUT HYPOTENSION AND TACHYCARDIA PERSISTED. THE PT WAS TAKEN TO THE OR FOR AN EMERGENCY THORACOTOMY WHICH REVEALED A SIGNIFICANT PERICARDIAL EFFUSION THAT RESPONDED TO OPENING AND DRAINAGE.
TPA BEING INFUSED VIA PUMP. SOLUTION INFUSED IN 45 MINS, SHOULD HAVE INFUSED IN 90 MINS.
WHILE SURGEON INTRODUCING 5 MM TROCAR DURING TUBAL LIGATION, PROTECTIVE SLEEVE DID NOT RETRACT AFTER PENETRATING THE ABDOMEN AND PUNCTURED THE BLADDER.
IAB WAS INSERTED AND BALLOON FAILED TO INFLATE. CORRECTIVE MEASURES WERE ATTEMPTED WITHOUT SUCCESS. FAILED IAB WAS REMOVED AND NEW IAB INSERTED WITHOUT DIFFICULTY. NO INJURY TO PT.
PT WAS TRANSFERRED FROM ANOTHER HOSP. AFTER ADMISSION TO FACILITY BALLOON COLLAPSED REQUIRING REPLACEMENT. IABP WAS NOT INSERTED AT THIS FACILITY.
SUPRAPUBIC FOLEY CATHETER INSERTED. FOUR WEEKS LATER, ATTEMPTS TO REMOVE THE CATHETER WERE UNSUCCESSFUL AS THE BALLOON WOULD NOT DEFLATE. PT WAS TAKEN TO THE OR WHERE A CYSTOSCOPY WAS PERFORMED TO DEFLATE THE BALLOON AND REMOVE THE CATHETER.
PT WAS FOUND ON FLOOR TO LEFT OF BED. LACERATION PRESENT AT RIGHT EYEBROW AREA. LEFT SIDE RAIL WAS DOWN. STAFF CANNOT ASCERTAIN THAT BED RAIL WAS IN THE UP POSITION JUST PRIOR TO THE FALL. UPON INSPECTION, THE LOCK ROD SPRING AND KNOB ASSEMBLY WAS INSTALLED INCORRECTLY WITH THE KNOB TOWARD THE INSIDE OF THE SIDE RAIL. THIS RESULTED IN A FALSE LOCK CONDITION, IF THE RAIL WAS RAISED GENTLY UNTIL A "CLICK" WAS HEARD. IN THE FALSE LOCK CONDITION, PRESSURE TO THE TOP OF THE RAIL CAUSED THE RAIL TO DROP DOWN.
PT HAD PENILE IMPLANT PLACED 1/95 AT ANOTHER HOSP. IMPLANT WAS REMOVED IN JUNE DUE TO INFECTION. ADMITTED FOR INSERTION OF PENILE PROSTHESIS ON 10/6/95. ON 10/9/95 IT WAS NOTED PT HAD BLISTERING AT THE GLANS PENIS; 10/10/95 PENILE PROSTHESIS WAS VISIBLE THROUGH THE GLANS PENIS ON THE RIGHT. PT RETURNED TO OR FOR REMOVAL OF PROSTHESIS.
PT SEEN IN ER WITH A DISLOCATED LEFT HIP PROSTHESIS WHICH HAPPENED WHEN SHE BENT OVER. PT HAS HAD SEVERAL SUCH EPISODES IN THE PAST. PT TAKEN TO OR FOR CLOSED REDUCTION.
SEVEN WEEKS AFTER HAVING LEFT LOWER EXTREMITY TOTAL KNEE REPLACEMENT, A PT DISCOVERED TWO SMALL BURNS BELOW HIS LEFT KNEE AS HE WAS UNDRESSING FOR BED. DURING THE DAY, HE HAD THERAPY IN THE OUTPATIENT PHYSICAL THERAPY SECTION OF HOSP'S PHYSICAL MEDICAL DEPARTMENT. THIS SESSION HAD INCLUDED INTERFERENTIAL ELECTROSTIMULATION FOR MANAGEMENT OF PAIN AND EDEMA IN THE OPERATIVE AREA. THE PT REPORTED HIS FINDINGS TO THE THERAPIST THE NEXT DAY, AND WAS ADVISED TO CONTACT HIS PHYSICIAN OR SEEK EMERGENCY ROOM TREATMENT IF NEEDED. FOUR TWO-INCH ROUND SELF-ADHERING REUSABLE TENS ELECTRODES HAD BEEN APPROPIATELY PLACED ABOVE AND BELOW THE LEFT KNEE WITH AN ICE PACK PLACED ON TOP OF THE KNEE CAP AREA, ARE THE INTERFERENTIAL CURRENT HAD BEEN DELIVERED WITH A DEVICE FOR TWELVE MINUTES. THE PT HAD TOLERATED THE TREATMENT WELL AND HAD OFFERED NO COMPLAINT OF DISCOMFORT BEFORE LEAVING FOR HOME WITH HIS NEXT SESSION BEING SCHEDULED FOR THE NEXT TUESDAY (FIVE DAYS LATER). WHEN HE RETURNED FOR HIS NEXT SESSION, HIS PHYSICAL THERAPIST, NOTING THAT THE BURNS WERE CONSISTENT WITH THE SHAPE OF THE ELECTRODES, CONTACTED THE PHYSICIAN COVERING FOR HIS ORTHOPEDIC SURGEON AND REQUESTED THAT HE EXAMINE HIM. THIRD DEGREE BURNS WERE IDENTIFIED AND SILVADENE OINTMENT WAS PRESCRIBED. PROPHYLACTIC ANTIBIOTICS WERE ADDED TO THE TREATMENT REGIMEN WHEN THE PT'S OWN PHYSICIAN RETURNED FROM VACATION A FEW DAYS LATER. ALTHOUGH THE UTILIZED ELECTRODES WERE IDENTIFIED AND SEQUESTERED AS SOON AS THE INJURY WAS REPORTED, THE DEPARTMENT WAS UNABLE TO IDENTIFY WHICH OF ITS TWO DEVICES HAD BEEN USED. THEREFORE, WHEN THE ELECTRODES AND AUXILIARY CABLES WERE FORWARDED TO THE HOSP'S BIOMEDICAL ENGINEERING DEPARTMENT FOR INSPECTION, BOTH DEVICES WERE ALSO SENT. NO PROBLEMS OR MALFUNCTIONS WERE IDENTIFIED WITH THE EQUIPMENT AND CABLES; ALL QUALITATIVE TESTS WERE PASSED. TWO OF THE ELECTRODES, HOWEVER, FAILED TO ADHERE SECURELY TO THE INSPECTOR'S ARM; AFTER A FEW MINUTES, THE SIDES OF THE ELECTRODE PATCHES BEGAN TO "BUCKLE," ALLOWING A POCKET TO FORM BETWEEN THE ELECTRODE PATCH AND THE SKIN. REVIEW OF THE THERAPY SESSION CIRCUMSTANCES WITH THE INVOLVED PHYSICAL THERAPIST REVEALED THAT ALL PROCEDURES HAD BEEN FOLLOWED. WHEN INSPECTED, THE ELECTRODES HAD APPEARED TO ADHERE TO THE PT'S LOWER EXTREMITY. FOLLOW-UP CONVERSATION WITH THE PT'S ORTHOPEDIC SURGEON REVEALED THAT THE BURNS ARE HEALING WELL AND THAT HE ANTICIPATES THAT THEY WILL CONTINUE TO "FILL IN" WITHOUT ADD'L TREATMENT.
PT FOUND ON FLOOR BETWEEN SIDERAILS WITH VEST AROUND NECK. RESTRAINT CUT OFF. PT PLACED BACK IN BED. COOL AND DIAPHORETIC, PULSE 92, RESPIRATIONS UNLABORED. RED MARK TO LEFT CHEEK.
PT HAD CAPD CATHETER PLACED IN 11/95. RECENTLY DEVELOPED A PERSISTANT PERITONITIS. HAS ABDOMINAL PAIN AND HAS REQUIRED ANTIBIOTIC THERAPY. AFTER A COURSE OF THERAPY BECOMES ASYMPTOMATIC. UPON RECULTURE STILL HAS BACTERIA GROWING FROM THE CATHETER; FEEL THE CATHETER ITSELF IS CONTAMINATED OR COLONIZED WITH THE BACTERIA. ADMITTED FOR REMOVAL OF HIS CAPD CATHETER.
PT HAD CATHETER PLACED ON 2/14/96. READMITTED ON 3/16/96 FOR CATHETER REMOVAL. 1-2 WEEKS POST INSERTION PT DEVELOPED A SWELLING IN THE ARM AND WAS IDENTIFIED AS HAVING A THROMBOSIS. WAS PLACED ON COUMADIN, SWELLING IMPROVED, BUT HAS CONTINUING PAIN IN THE ARM.
PT BROUGHT INTO ER BY RESCUE ON 6/7/96. PARENTS STATED WHILE TAKING RECTAL TEMP, MERCURY RECTAL THERMOMETER BROKE OFF AT THE END OF RECTAL BULB INTO THE PT'S RECTUM.
ON 1/12/96 AT 2134 PACER CAPTURE LOST REQUIRING ADMINISTRATION OF ATROPINE, EPINEPHRINE, ISUPREL, DOPAMINE AND CPR ENSUED. EXTERNAL PACER APPLIED. INTERMITTENT LOSS OF CAPTURE UNTIL 0630 WHEN CAPTURE RESTORED. PT DISCHARGED ON 2/9/96 WITH PT DISCHARGE DIAGNOSIS OF ENCEPHALOPATHY. PROBABLY SECONDARY TO PACEMAKER FAILURE.
SIX HOLE 100 DEGREE TUBULAR PLATE WITH 4 3.5 MM VERTICAL SCREWS IMPLANTED ON LEFT RADIUS ON 4/13/96. PLATE BROKE AT SCREW HOLE. REPORTED TO HOSP ON 6/8/96. PLATE AND SCREWS WERE REMOVED AND REPLACED ON 6/8/96.
PT ADMITTED THROUGH THE EMERGENCY DEPT WITH CHEST PAIN. CXR REVEALED FREE AIR BELOW THE LEFT HEMIDIAPHRAGM, REPEAT CXR REVEALED THE SAME. DIAGNOSIS IN ED PERFORATED ABDOMINAL VISCOUS, PROBABLE PERFORATED ULCER. TAKEN TO SURGERY FOR EMERGENCY LAPAROTOMY, UPON EXPLORATION NO PERFORATION WAS LOCATED ANYWHERE WITHIN THE STOMACH OR GI TRACT. GANGRENOUS GALLBLADDER WAS FOUND AND REMOVED. UPON REVIEW BY THE RADIOLOGIST FELT FREE AIR NOTED ON FILM WAS ACTUALLY ARTIFACT ON THE FILM. CONCERN IS POTENTIAL EXISTED FOR UNNECCESSARY SURGERY. CO WAS CONTACTED ON TUESDAY 1/2.
THE PT WAS ADMITTED TO THE ENDOSCOPY SUITE FOR COLONOSCOPIC EXAM TO RULE OUT RECURRENT MALIGNANCY. ONE YR PRIOR TO THIS ADMISSION, SHE HAD BEEN DIAGNOSED WITH COLORECTAL ADENOCARCINOMA; A COLON RESECTION WITH TEMPORARY COLOSTOMY HAD BEEN PERFORMED. THIS SURGERY HAD BEEN FOLLOWED BY A COURSE OF CHEMOTHERAPY AND SHE HAD RECENTLY BEGUN TO EXPERIENCE LOWER ABDOMINAL PAIN. AFTER VERSED/DEMORAL SEDATION, THE COLONOSCOPE WAS INTRODUCED. AT 20-30CC, COLONIC NARROWING WAS ENCOUNTERED. BECAUSE OF THE PT'S DISEASED ANATOMY, DESPITE ATTEMPTED DILATION WITH A 60 FRENCH COLONIC RIGIFLATOR, THE AREA WAS UNABLE TO BE DILATED. AT THIS TIME, THE PT'S ABDOMEN BECAME DISTENDED AND SHE COMPLAINED OF INCREASED DISCOMFORT. A GASTROSCOPE WAS INTRODUCED AND A NASOGASTRIC TUBE WAS PASSED IN AN EFFORT TO RETRIEVE THE GAS WHICH HAD BUILT UP IN THE COLONIC AREA BEYOND THE NARROWED PORTION. A STAT FLAT PLATE X-RAY OF THE ABDOMEN AND CHEST REVEALED A PERFORATED VISCUS WITH FREE AIR, AND AFTER EXAM BY A SURGEON SHE WAS TRANSFERRED TO THE OPERATING ROOM FOR EXPLORATORY LAPAROTOMY. SURGICAL FINDINGS INCLUDED WIDESPREAD METASTATIC CARCINOMATOSIS IN THE AREA OF THE COLON, SMALL BOWEL, OMENTUM AND MESENTARY, AN UMBILICAL HERNIA, AND A PERFORATION IN THE AREA OF THE CECUM. MULTIPLE ADHESIONS WERE LYSED, SPECIMENS EXCISED FOR BIOPSY, THE HERNIA AND CECAL PERFORATION WERE REPAIRED AND A COLOSTOMY WAS CREATED IN THE AREA OF THE PREVIOUS ONE. DISCUSSIONS WITH THE INVOLVED GASTROENTEROLOGIST  AND NURSE, AND EXAM BY THE HOSP'S BIOMEDICAL ENGINEERING DEPARTMENT OF ALL EQUIPMENT USED DURING THE PROCEDURE, REVEALED NEITHER DEVIATION FROM STANDARD PRACTICE OF CARE NOR DEFECT WITH THE EQUIPMENT. ACCORDING TO THE PHYSICIAN, HIS PT'S FRIABLE TISSUE CAUSED BY HER DISEASE PROCESS WAS A MAJOR FACTOR IN THIS UNFORTUNATE OCCURRENCE. IT IS PRESUMED, IN RETROSPECT, THAT THE CECAL AREA, WEAKENED BY MALIGNANCY WAS NOT STRONG ENOUGH TO MAINTAIN THE PRESSURE OF THE AIR WHICH WAS INJECTED FOR THE COLONOSCOPIC EXAM.
AFTER ONE HOUR INTO OPEN-HEART SURGERY PROCEDURE, PERFUSIONIST NOTICED LARGE BOLUS OF AIR FROM VENOUS RESERVOIR TO PUMP HEAD. TUBING CLAMPED OFF, AIR ELIMINATED BUT WHEN TURNING PUMP BACK ON, IT FAILED TO START. REPLACED WITH SECOND PUMP.
PT HAD BRIEF EPISODES OF SYNCOPE X1 DAY. ON 7/15/96, PT EXPERIENCED A FRANK EPISODE OF SYNCOPE WITH LOSS OF CONSCIOUSNESS. THE PT HIT HOS HEAD IN THE PROCESS CAUSING A LACERATION DUE TO MULTIPLE PAUSES REQUIRING SURGICAL REPLACEMENT OF THE PACER GENERATOR DUE TO MALFUNCTION AT LEAD CONNECTION.
PT ADMITTED FOR VIDEO ARTHROSCOPY. PRE-OP DIAGNOSIS OF ANTERIOR CRUCIATE LIGAMENT INSUFFICIENCY, POSSIBLE MENISCUS TEAR RIGHT KNEE. PROCEDURE PERFORMED. POST-OP, PT HAD SIGNIFICANT PROBLEMS REGARDING DISTENSION OF THIGH AND/OR KNEE. ETIOLOGY DUE TO POOR PRESSURE REGULATION ON INFLOW PRESSURE PUMP.
DURING SUBCUTANEOUS SUTURING OF ABDOMINAL AREA TIP OF NEEDLE BROKE OFF IN PT'S SUBCUTANEOUS TISSUE. DATE DEVICE EXPIRES: 1/2000.
15 YR OLD AMERICAN INDIAN MALE ADMITTED FOR CURRETAGE AND BONE GRAFTING RT. TIBIAL ANEURYOMAL BONE CYST. TOURNIQUET APPLIED TO RIGHT THIGH AND INFLATED TO 350MM HG. DURING PROCEDURE PT HAD QUITE A BIT OF BLEEDING AND TOURNIQUET INCREASED TO 400 MM HG. THE TOURNIQUET LOST ITS PRESSURE AND WENT TO 200 MM HG. IT WOULD FLUCTUATE BETWEEN 200-400 MM HG. IT WOULD NOT STAY AT 400 MM HG. A SECOND TOURNIQUET APPLIED AT 400 MM HG AND THE FIRST TOURNIQUET REMOVED. BLOOD LOSS FOR PT WAS 1500CC. PT TYPED AND CROSS MATCHED FOR BLOOD BUT WAS NOT TRANSFUSED.
PT ADMITTED FOR INTERNAL DERANGEMENT RIGHT KNEE, POSSIBLE TEAR MEDIAL MENISCUS. VIDEO ARTHROSCOPY PERFORMED. POST-OP PT HAD SIGNIFICANT PROBLEMS REGARDING DISTENSION OF THIGH AND/OR KNEE. ETIOLOGY DUE TO POOR PRESSURE REGULATION ON INFLOW PRESSURE PUMP.
LONG HISTORY OF CAPSULAR CONTRACTURE. HAS HAD SEVERAL SURGERIES, BOTH UNILATERAL AND BILATERAL, TO REMOVE AND REPLACE HER BREAST IMPLANTS. THIS SURGERY WAS TO REMOVE AND REPLACE HER LEFT BREAST IMPLANT, CAPSULOTOMY AND REPLACE WITH THE SAME IMPLANT.
PLASTIC TIP OF IMPACTOR BROKEN OFF WHEN USED DURING OPERATIVE PROCEDURE FOR OPEN REDUCTION, INTERNAL FIXATION LEFT HIP. PIECES FOUND, WOUND IRRIGATED.
GIANT CELL GRANULOMATOUS RESPONSE ELICITED BY BONE WAX POST-BUNIONECTOMY. PT RECEIVED ORIGINAL SURGERY FOR BUNIONECTOMY 11/1/95, IN WHICH BONE WAX WAS USED AS AN ANTI-ABRASIVE AGENT. PT COMPLAINED OF POST-OPERATIVE PAIN - TESTS FOR GOUT ETC, ALL NEGATIVE. NO SWELLING OR ERYTHEMA. PT RETURNED TO SURGERY 2/21/96 AND THE SURGICAL SIGHT REOPENED. A FLAKY MATERIAL WAS BATHED IN THE BLOOD MATERIAL AND THERE WAS A YELLOW CHEESY TYPE MATERIAL AS WELL AND DETERIORATION OF THE OSTEOTOMY SITE PREVIOUSLY. THE BONE HOWEVER, DEEP IN THE CANCELLOUS AREA WAS HARD AND CORTICAL. GENERAL ANESTHESIA USED IN BOTH CASES.
DRIP INFUSING PER PROXIMAL LUMEN OF TRIPLE LUMEN CVP CATHETER. WHEN HANGING NEW BAG AND TUBING, TIP OF FILTER BROKE OFF IN RPOXIMAL LUMEN. UNABLE TO REMOVE TIP. UNABLE TO USE LUMEN. ANOTHER IV SITE HAD TO BE OBTAINED AS THE MEDIAL AND DISTAL LUMENS WERE ALREADY BEING USED. TUBING BREAKS EASILY, NOTHING TO "GRIP" ONTO.
EMERGENCY ROOM TAPED A PATCH OVER THE PT'S INJURED EYE. THE PT SUSTAINED SEVERE REACTION TO THE TAPE. SEVERE SWELLING, UNTIL EYE ALMOST CLOSED, SEVERE ITCHING AND REDNESS. SOME BLISTERING. TAPE ON FROM 7/3/96 TO 7/4/96, APPROX 24 HRS.
LEAK THROUGH FILTER. 2ND OCCURRENCE WITH THIS LOT.
PT WITH DIARRHEA UNDERWENT FLEXIBLE SIGMOIDOSCOPY. INSTRUMENT WAS PASSED TO 60 CM. BIOPSIES OBTAINED FROM NORMAL APPEARING SIGMOID COLON WITH FORCEPS. TWO HRS LATER, PT COMPLAINED OF ABDOMINAL PAIN, FEVER. NOTED TO HAVE EVIDENCE OF PERITONITIS AND WBC OF 13,000. LAPAROTOMY CONFIRMED SMALL PERFORATION IN SIGMOID COLON WHICH WAS CLOSED PRIMARILY. PT DISCHARGED FROM HOSP AFTER 7 DAYS.
510K #950928, 1 PERSON. IS FREQUENCY OF OCCURRANCE OF THIS EVENT ADDRESED IN THE DEVICE LABELING? N, IF NO, THEN IS FREQUENCY OF THIS EVENT GREATER THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N, IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL. U.
PT COULD NOT GET PUMP TO TURN ON. WHEN RPTR RAN TEST ON PUMP THEY ALSO COULD NOT GET PUMP TO POWER UP. RPTR SENT PUMP TO CO FOR REPAIR.
WHEN STUDENT NURSE TRIED TO FILL SYRINGE WITH MEDICINE 0.2CC WAS PULLED INTO BARREL AND THEN THE NEEDLE ALSO PULLED INTO BARREL. 0.2CC OF CALCIMAR WAS WASTED DUE TO FAULTY SYRINGE.
AV PACING GENERATOR PLACED IN DVI MODE. WHEN PACER TURNED ON, LARGE PACING SPIKE NOTED ON ECG MONITOR ON T WAVE. 12 BEATS, SELF LIMITING EPISODE OF VENTRICULAR TACHYCARDIA NOTED. QUESTION OF ELECTRICAL DYSFUNCTION OF PACER.
THE DEVICE WAS FORWARDED TO THE MFR, ACCU-TUBE, FOR COMPLAINT ANALYSIS. THE DEVICE WAS PRESSURIZED AND THE COMPLAINT OF LEAKAGE WAS CONFIRMED. THE AREA OF LEAKAGE WAS MICROSCOPICALLY EXAMINED TO DETERMINE THE CAUSE. IT APPEARS THAT THERE WAS A WEAK AREA NEAR THE EDGE OF THE WELD SEAM WHICH DURING THE COILING PROCESS, ENLARGED AND CAUSED THE TUBE TO LEAK DURING CLINICAL USE. TO ADDRESS THIS ISOLATED FAILURE MODE, THE MFR OF THE COMPONENT, ACCU-TUBE, HAS IMPLEMENTED SEVERAL CORRECTIVE ACTIONS INTO THEIR MFG PROCESS: INSTALLED AN EDDY-CURRENT MACHINE ON THE WELD MILL WHICH WILL AUTOMATICALLY MARK, WITH INK, ANY WEAK AREA ON THE TUBING AS IT IS BEING WELDED. DURING THE PRODUCTION PROCESS, TO HELP ELIMINATE THE POSSIBILITY OF HUMAN ERROR, A COIL WHICH FAILS ANY OF OUR TESTING PROCEDURES WILL BE IMMEDIATELY DISFIGURED SO THAT IT WILL BE IMPOSSIBLE TO BE MISTAKEN FOR A GOOD COIL.
510K#950928 1 PERSON. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N, IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N, IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
PHYSICAL THERAPIST USING NEUROMUSCULAR STIMULATOR ON PT. LEFT PT WITH UNIT OPERATING FOR A REPORTED TIME PERIOD OF A FEW (45) SECS. PT YELLED FOR ASSISTANCE AND TECH LOOKED AT DISPLAY. SETTINGS HAD MOVED FROM 8/11 TO BEING 8/63. SHUT DOWN UNIT AND REMOVED ELECTRODES ON SIDE OF HER NECK. TESTED CALIBRATION WITH MFR (AND REVIEWED TESTING PROCEDURE). IDENTIFIED POSSIBILITY THAT PADS WERE DEFECTIVE.
510K #950928 1 PERSON. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED INTHE DEVICE LABELING? N, IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT THANIS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N, IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
ANESTHESIA RESIDENT AFTER DONNING HER FACE MASK COMPLAINED OF FACIAL SORENESS AND BURNING. UNDER THE MASK, IN THE PERIORAL AREA, WHERE THE MASK CONTACTED THE FACE, THERE WAS A LARGE ERYTHEMATOUS LESION, SORE TO TOUCH. MASK WAS REMOVED AND TOPICAL CORTICOSTEROID CREAM APPLIED WITH SOME RELIEF.
OPERATING ROOM TECH PUT ON A FACE MASK THAT CAUSED HER TO HAVE AN ASTHMA ATTACK. THIS TECH USED HER OWN ASTHMA MEDICATIONS WITH RELIEF.
OR TECH REPORTED FACE RASH AND ITCHING AFTER APPLYING A FACE MASK. TREATED WITH STEROID CREAM WITH RELIEF.
PT HAS FALLEN TWICE-BOTH WERE UNATTENDED ON A LEVEL FLOOR IN THE DAY ROOM-NO CARPET-NO REASON FOR THE FALL-1ST FALL-FORWARDED-8:06 PM-6/30/96-EXAM AT THE HOSP-DID NOT STAY IN HOSP. 2ND FALL-SIDEWAYS TO THE LEFT. EXAM AT THE HOSP-MRI SCAN-NOSE FRACTURE-2 BLACK EYES-FACE SWOLLEN-DID NOT STAY IN HOSP. THIS HAPPENED ON 7/27/96-2:45 PM.
PT EXPERIENCED SHORTNESS OF BREATH AND CHEST TIGHTNESS DURING MIDLINE CATHETER INSERTION, PARTICULARLY BETWEEN THE PERIOD OF FLUSHING AND CATHETER ADVANCEMENT. THE CATHETER WAS REMOVED AND BENADRYL IM ADMINISTERED.
IT WAS REPORTED THE UNIT EMITTED FIRE. CO INSPECTION REVEALED A 1/2" X 1 1/2" BURN HOLE THROUGH BOTH SIDES OF THE PAD CAUSED BY THERMOSTAT CONNECTION ARCING. NO DEATHS OR INJURIES WERE REPORTED.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y, IF YES, THEN IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y, IF YES, THEN IS SEVERITY OF THIS EVENT GREATER THAN LABELED? N.
ELECTROHYDRALIC LITHOTRIPTOR WAS BEING USED IN OR. IT WAS NOTED THAT THE CABLES WERE IN THE WRONG PORT. AS THE RN WAS ABOUT TO REMOVE THE CABLES, SHE AND THE PT EXPERIENCED A SHOCK. LITHOTRIPTOR WAS REMOVED BY BIOMEDICAL ENGINEERING AND ALL THE TESTS PERFORMED AS PER MFR'S SPECS.
STAPLER WAS PLACED AROUND STUMP OF APPENDIX. WHITE HANDLE, THEN BLOCK HANDLE CLOSED AND MADE LOUD CRACKING SOUND, THEN WOULD NOT RELEASE. WHEN FINALLY RELEASED THE STAPLES WERE NOT CRUSHED AND ONE SIDE OF APPENDIX WAS CUT LEAVING A HOLE IN CECUM. NO GROSS SPILLAGE OCCURRED. A SECOND STAPLER FIRED WITHOUT DIFFICULTY. PT HAD NO APPARENT COMPLICATIONS.
TWO BREAST LOCALIZATION NEEDLES INSERTED WITHOUT DIFFICULTY (MAMMOGRAPHICALLY GUIDED). SATISFACTORY POSITION CONFIRMED. SECURED IN PLACE AND PT SENT TO SURGERY. WHILE DISSECTING DOWN AND AROUND THE MORE ANTERIOR HOOK WIRE, SURGEON WAS SIMPLY HOLDING THE WIRE AND IT SNAPPED OFF. SURGEON DENIES CUTTING, BENDING OR APPLYING UNDUE TRACTION. ABLE TO DISSECT AROUND THE REMAINING FRAGMENT OF WIRE AND REMOVE IT. THE MORE POSTERIOR WIRE REMOVED WITHOUT DIFFICULTY. SMALL FRAGMENT RETAINED.
CATHETER INSERTED IN ANTECUBITAL VEIN. EASILY INSERTED, BLOOD RETURN NOTED. PT DID JERK ARM WHEN CATHETER INSERTED BUT ADVANCED WITHOUT DIFFICULTY. BLOOD WORK DRAWN FROM SITE BUT WHEN FLUID INITIATED, SITE INFILTRATED. WHEN CATHETER DISCONTINUED, RN FELT CATCH. CATHETER APPEARED RAGGED AND PORTION MISSING. X-RAYS NOTED 1 CM LENGTH OF TUBING JUST UNDER SKIN AT ANTECUBITAL AREA.
BOTH COATINGS APPEARED DEFECTIVE AT PT END AND UNRAVELING. PHYSICIAN THOUGHT POSSIBILITY (REMOTE) OF PIECE OF WIRE COATING LEFT URETER.
WIRE FRAYED DURING USE. REMOTE POSSIBILITY THAT MINUTE FRAGMENT RETAINED IN URETER.
VENOUS ACCESS DEVICE IMPLANTED ON 1/2/96 WITHOUT INCIDENT. ON 1/29/96 PORT PATENT BUT THROMBOSIS IN BRACHIOCEPHALIC VEIN. ON 4/2/96 DUE TO LEFT ARM SWELLING CONTRAST INJECTED INTO PORT. LEAK FROM PORT DEMONSTRATED AND DEVICE REMOVED. POST REMOVAL COULD NOT REENACT LEAK.
PT WAS A S/P BILATERAL MASTECTOMIES FOR CANCER. BILATERAL RECONSTRUCTIVE SURGERY WAS PERFORMED ON 10/22/82 UTILIZING SILICONE MAMMARY PROSTHESIS. IN 2/83 THE RIGHT IMPLANT AND CAPSULE WAS REMOVED DUE TO INFECTION. ON 9/26/84 RECONSTRUCTION OF RIGHT BREAST WAS PERFORMED UTILIZING 150CC SILICONE MAMMARY PROSTHESIS. RECENTLY MRI SHOWED EVIDENCE OF RUPTURE OF LEFT BREAST. ON 1/3/96 PT WAS ADMITTED TO THE HOSP TO UNDERGO REMOVAL OF RUPTURED IMPLANTS. AT TIME OF SURGERY, THE LEFT BREAST IMPLANT WAS FOUND TO BE COMPLETELY COLLAPSED WITH MOST OF THE SILICONE OUTSIDE THE ENVELOPE OF THE IMPLANT, BUT WITHIN THE CAPSULE OF THE BREAST. THE SILICONE WAS REMOVED AND ALSO THE ENVELOPE. REPLACEMENT WAS ACCOMPLISHED WITH A SALINE IMPLANT.
PT HAD A LEFT TOTAL KNEE REPLACEMENT DONE APPROX 10-15 YRS AGO. OVER RECENT YEARS HAS DEVELOPED INCREASING DIFFICULTY AND PAIN WITH LEFT KNEE. ATTEMPTS AT CONSERVATIVE THERAPY FAILED, INCLUDING CORTICOSTEROID INJECTION. ON 2/8/96 PT WAS ADMITTED TO THE HOSP AND UNDERWENT REVISION SURGERY. AT TIME OF SURGERY THERE WAS FOUND TO BE BLACKENED WEAR DEBRIS THROUGHOUT THE KNEE WITH BLACKENED SYNOVITIS THROUGHOUT ALMOST THE ENTIRE KNEE JOINT. THE TIBIAL INSERT WAS KNOWN TO BE OF THE ERA OF CARBON FIBER REINFORCED POLYETHYLENE. THERE WAS WEAR EVIDENT ON THE TIBIAL COMPONENT AND THE COMPONENT APPEARED A BIT LOOSE. THE PATELLAR COMPONENT WAS ALSO SIGNIFICANTLY WORN AND WAS REMOVED WITH FINGER PRESSURE. THE FEMORAL COMPONENT WAS NOT WORN BUT WAS NOTED TO BE IN ABOUT 45 DEGREES FLEXION. IT DID APPEAR TO BE FAIRLY SNUG. DEBRIDEMENT OF ALL BLACKENED SOFT TISSUE DEBRIS ABOUT THE JOINT WAS PERFORMED. POST-OPERATIVE DIAGNOSIS WAS PAINFUL, LOOSENED LEFT TOTAL KNEE WITH TIBIAL POLYETHYLENE WEAR AND SYNOVITIS SECONDARY TO WEAR DEBRIS. REVISION WAS CARRIED OUT.
PT HAD A LEFT TOTAL KNEE REPLACEMENT DONE ON 9/14/95 IN PHILADELPHIA. THERE IS SOME QUESTION AS TO PT DEVELOPING A WOUND INFECTION AND WOUND DEHISCENCE IN THE POST-OP PERIOD, REQUIRING DEBRIDEMENT AND SKIN GRAFTING. IT IS NOT CLEAR WHETHER THE JOINT ITSELF WAS DEBRIDED. THIS INFO IS OBTAINED FROM THE PT, WHO ALSO NOTES HE WAS IN THE HOSP FOR 4 MONTHS AT THE TIME OF HIS REPLACEMENT SURGERY. HE ALSO NOTES THAT SINCE THE TIME OF HIS SECOND SURGICAL PROCEDURE AND SKIN GRAFTING AT THE LEFT KNEE, HE HAS HAD A SCAB DIRECTLY OVER THE ANTERIOR ASPECT OF THE LEFT KNEE WHICH HAS INTERMITTENTLY FALLEN OFF AND DRAINED. RECENTLY, OVER A PERIOD OF SEVERAL DAYS, HE HAD DEVELOPED PAINFUL ERTHYEMA AND SWELLING OF THE LEFT LOWER EXTERMITY. HE WAS ADMITTED TO THE HOSP ON 5/9/96 AND PLACED ON IV ANTIBIOTICS AND HEPARIN. A C&S OF PUS FROM THE KNEE JOINT GREW STAPH AUREUS AND PSEUDOMONAS. ORTHOPEDIC CONSULT RECOMMENDED DUE TO THE EXTENSIVE BONE INVOLVEMENT AND CELLULITIS OF LOWER LEG, ALL WOULD INDICATE POOR PROGNOSIS FOR ANY JOINT DEBRIDEMENT AND FUTURE ATTEMPTS TO BE REIMPLANTED OR ATTEMPT TO FUSE KNEE. ON 5/15/96 PT UNDERWENT A LEFT ABOVE THE KNEE AMPUTATION. FINDINGS WERE INFECTED LEFT TOTAL KNEE REPLACEMENT WITH OSTEOMYELITIS.
PT SCHEDULED FOR CATARCT EXTRACTION WITH IOL IMPLANT, LEFT EYE, ON 5/23/96. DURING THE PROCEDURE, FOLLOWING REMOVAL OF THE CATARACTOUS LENS, A 20.5 DIOPTER POSTERIOR CHAMBER LENS WAS INSERTED INTO THE CAPSULAR BAG USING FINE II FORCEPS AFTER PREVIOUSLY FOLDING WITH A FOLDER. AFTER RELEASING THE INTRA-OCULAR LENS, IT APPEARED DESENSORED INFEROTEMPORALLY. CLOSE INSPECTION REVEALED THAT THE LEADING HAPTIC HAD BEEN AMPUTATED AT THE HAPTIC-OPTIC JUNCTION. A 5.7 MM FEATHER BLADE WAS USED TO ENLARGE THE 4.0 MM INTERNAL CORNEAL VALVE. THE POSTERIOR LENS WAS STABILIZED WITH ADD'L VISCOELASTIC AID. IT WAS REMOVED USING FORCEPS. THIS OCCURRED ATRAUMATICALLY. THE REMAINING LEADING HAPTIC WAS REMOVED FROM THE EYE VIA GENTLE IRRIGATION. THIS CAUSED THE HAPTIC TO ENTER THE 5.7 MM CORNEOSCLERAL TUNNEL. IT WAS THEN REMOVED WITH A STRAIGHT FORCEPS. RESIDUAL VISCOELASTIC AID WAS REMOVED WITH THE IRRIGATION/ASPIRATION HAND PIECE. REPLACEMENT WAS THEN DONE WITH A DIFFERENT PSOTERIOR CHAMBER LENS.
PT UNDERWENT A PACEMAKER INSERTION IN 1991. IN 3/96, HAD PACEMAKER GENERATOR CHANGE. AT THAT TIME LEADS WERE CHECKED AND WERE FUNCTIONING NORMAL. ON 6/11/96, DURING A ROUTINE PHYSICIAN OFFICE VISIT, PACEMAKER INTERROGATION REVEALED INTERMITTENT CAPTURE OF THE VENTRICLE. INTERROGATION VALUES REVEALED THE PACEMAKER GENERATOR FUNCTION WAS NORMAL. ATRIAL LEAD DATA WAS NORMAL. VENTRICULAR LEAD DATA SHOWED VERY LOW RESISTANCE, NON-CAPTURE AND OVER SENSING OF R WAVES. DATA WAS CONSISTENT WITH INSULATION MATERIAL FRACTURE OF THE VENTRICULAR LEAD. CHEST X-RAY SHOWED BOTH THE ATRIAL AND VENTRICULAR LEADS WERE IN THEIR NORMAL POSITION. PT WAS ADMITTED TO THE HOSP ON 6/11/96 AND ON THAT DATE UNDERWENT PLACEMENT OF NEW ATRIAL AND VENTRICULAR PACEMAKER WIRES.
PT NOTED TO HAVE FOREIGN BODY IN L MAINSTEM BRONCHUS. AFTER REMOVAL, IDENTIFIED SUGGESTIVE OF TIP OF SUCTION CATHETER.
DURING A PROCEDURE ON A FRACTURED LEFT FEMUR SUCCESSIVE FLEXIBLE REAMINGS WERE PERFORMED IN THE PROXIMAL PORTION OF THE FEMUR. THE REAMER BROKE LEAVING THE END OF THE REAMER AND THE REAMER BIT WITHIN THE FEMORAL SHAFT. THE SURGEON WAS UNABLE TO REMOVE FROM ABOVE. ADD'L SURGERY WAS NEEDED TO FACILITATE REMOVAL OF THE PIECES.
ON 3/8/96, ATTEMPT WAS MADE TO PLACE STENT, IT WAS NEVER EXPANDED. STENT WAS NOT ON CATHETER WHEN THE CATHETER WAS REMOVED. UNABLE TO FIND STENT. PT HAD GOOD PERIPHERAL PULSES, DID WELL AND WAS DISCHARGED. ON 3/15/96 PT WAS READMITTED WITH CHEST PAIN. ANGIOGRAPHY REVEALED COMPLETE OCCLUSION OF RCA. UN-DEPLOYED, NON-EXPANDED STENT NOTED AT SITE OF OCCLUSION VIA ANGIOGRAPHY. PT WENT TO SURGERY AND HAD A SUCCESSFUL CABG.
PT UNDERWENT A RADICAL PROSTATECTOMY, AND FOLEY CATHETER WAS INSERTED DURING THE SURGICAL PROCEDURE. TWO (2) DAYS POST-OP, THE FOLEY CATHETER FELL OUT WHEN THE PT STOOD TO AMBULATE. APPARENTLY, THE BALLOON HAD RUPTURED. THIS REQUIRED A RETURN TO SURGERY THAT DAY FOR CYSTOSCOPY AND REINSERTION OF THE CATHETER. PT SUBSEQUENTLY DEVELOPED A FISTULA; NOT CLEAR IF RELATED TO EVENT INVOLVING CATHETER REINSERTION.
RIGHT SUBCLAVIAN PORT CATHETER, WHICH WAS ORIGINALLY INSERTED 4/29/94, FRACTURED IN PT. FRAGMENT RETRIEVED UNDER FLOUROSCOPY VIA FEMORAL VEIN APPROACH 12/22/95. NO COMPLICATIONS. PORT REMOVED 12/29/95.
DISPOSABLE PENCIL PROBE FROM ELECTROSURGICAL UNIT CAUSED BURN ON ABDOMEN. CLINICAL INVESTIGATION REVEALED COAG BUTTON DOES NOT RELEASE.
WHEN THE NON-FUNCTIONING PORT WAS BEING REMOVED IN THE OR, A PORTION BROKE OFF AND HAD TO BE RETRIEVED IN THE RADIOLOGY DEPT. THESE EFFORTS WERE UNSUCCESSFUL, HOWEVER, SINCE THE PORTION OF CATHETER WAS IMBEDDED IN THE WALL OF THE LEFT INOMINATE VEIN.
STENT CAME OFF OF DELIVERY DEVICE WHEN MD INADVERTENTLY PULLED BACK PROTECTIVE SLEEVE. STENT WAS RETRIEVED OUT OF CORONARY, BUT WAS LOST BEFORE EXITING BODY. NEW STENT WAS DEPLOYED LEAVING NICE RESULT IN CIRCUMFLEX.
DURING THE SURGICAL REMOVAL OF THE PORT, THE CATHETER WAS NOT ATTACHED. X-RAY SHOWED THE PORTION OF CATHETER IN THE RIGHT ATRIUM EXTENDING INTO THE RIGHT VENTRICLE. THE PT WAS TAKEN TO THE RADIOLOGY DEPT FOR SUCCESSFUL RETRIEVAL OF THE CATHETER. NO INJURY TO THE PT.
STENT CAME OFF OF DELIVERY SYSTEM DURING DEPLOYMENT ATTEMPT AND LODGED IN MID RCA. MD DID NOT ATTEMPT TO RETRIEVE OR DISPLACE STENT. PROTECTIVE SLEEVE WAS NEVER PULLED BACK. VESSEL IMPLANTED IN RCA.
WHEN THE PT'S PORT WAS REMOVED IN THE OR THE CATHETER WAS NOTED TO BE SHORTER THAN ANTICIPATED. AN X-RAY SHOWED A PORTION TO BE IN THE RIGHT ATRIUM/VENTRICLE AREA. THE PT WAS SENT TO RADIOLOGY FOR RETRIEVAL OF THE PORTION OF CATHETER. THE PROCEDURE WAS SUCCESSFUL AND THERE WAS NO PT INJURY.
PT HAD LASER ANGIOPLASTY. LASER WAS CHECKED AND REPAIRED PRIOR TO PROCEDURE. CO REPAIR MADE ALL TECH ADJUSTMENTS DURING PROCEDURE. PT DEVELOPED POSS. PERFORATIONAL/CORONARY ARTERY DISSECTION. TRANSFERRED TO O.R. DURING POST PROCEDURE ENERGY CHECKS A MALFUNCTION WAS NOTED BY THE CO REP. CO CALLED AGAIN TO MAKE REPAIRS.
MALFUNCTION OF INFLATABLE PENILE PROSTHESIS SECONDARY TO ANEURYSMAL DILATION OF LEFT PENILE CYLINDER.
LEFT MAIN WAS TRAUMATIZED WHEN BALLOON WAS USED TO ATTEMPT TO DILATE CX. BALLOON WAS NEVER PASSED INTO CX, BUT PULLED OUT WHEN RESISTANCE MET IN LEFT MAIN. PT WAS SENT TO SURGERY. PTCA WAS ABORTED.
RIGHT BREAST PROSTHESIS RUPTURED AND SILICONE PRESENT IN CLOSE PROXIMITY TO SKIN. BREAST HAD BECOME QUITE FIRM AND UNCOMFORTABLE. EXCHANGE OF RIGHT BREAST PROSTHESIS WITH TOTAL CAPSULECTOMY AND REINSERTION OF SALINE-FILLED BREAST PROSTHESIS WERE PERFORMED ON 5/3/96.
THIS DEVICE WAS IMPLANTED ON 2/8/95. ON VISIT TO PHYSICIAN'S OFFICE ON 7/31/96 FOR CHEMOTHERAPY, THE NURSE WAS UNABLE TO INFUSE. THE PT STATED HE FELT A 'POP'. PT WAS THEN SENT TO THE IMPLANTING SURGEON'S OFFICE. THE CATHETER WAS DISCONTINUED AT THE HUB OF "TITANIUM PORT". THE PORT WAS REMOVED AND PT WAS SENT TO RADIOLOGY AT ANOTHER HOSP. THE RADIOLOGIST WAS ABLE TO RETRIEVE THE CATHETER.
THIS REPORT IS SUBMITTED ON BEHALF OF THE DEVICE MFR, THE LARYNGEAL MASK CO LTD., AND ESSENTIALLY DUPLICATES INFO AREADY PROVIDED TO FDA BY THE DISTRIBUTOR. PLEASE NOTE THAT THE MFR IS USING THE DISTRIBUTOR'S REPORTING NUMBER FOR IDENTIFICATION PURPOSES UNTIL A SEPARATE NUMBER IS ISSUED FOR THE MFR.
PT UNDERWENT ELECTIVE CEREBROVASCULAR SURGERY FOLLOWING A SUBARACHNOID HEMORRHAGE. A SIZE 5 LMA WAS USED FOR MAINTENANCE OF ANESTHESIA, AND A SIZE 7.5 MM TRACHEAL TUBE WAS PASSED THROUGH THE MASK FOR AIRWAY MANAGEMENT. A NASOGASTRIC TUBE WAS THEN PASSED THROUGH THE PARTIALLY DEFLATED LMA TO FACILITATE GASTRIC EMPTYING AND FOR LATER ENTERAL NUTRITION ADMINISTRATION. THE PROCEDURE LASTED FOR 8 HRS AND THE INTRAOPERATIVE COURSE WAS UNREMARKABLE. POSTOPERATIVELY THE PT WAS TRANSFERRED TO ICU FOR ELECTIVE VENTILATION. THE PHYSICIAN DECIDED TO LEAVE THE LMA IN PLACE, BUT WITH THE CUFF SEMI-INFLATED, SINCE IT WAS BELIEVED THAT ATTEMPTS TO REMOVE IT MAY RESULT IN ACCIDENTAL EXTUBATION OF THE TRACHEAL TUBE, AND POSSIBLY STIMULATE THE CARDIOVASCULAR SYSTEM IN THE PRESENCE OF THE NEWLY CLIPPED ANEURYSM. NEUROLOGICAL FUNCTION RETURN WAS DELAYED; THEREFORE THE LMA AND THE ENDOTRACHEAL WAS NOT REMOVED UNTIL 8 DAYS AFTER SURGERY. DURING THIS TIME THERE WAS NO APPARENT PROBLEMS WITH THE LMA OR ENDOTRACHEAL TUBE. IMMEDIATELY PRIOR TO REMOVAL THE PT WAS ALERT AND ORIENTED WITH ADEQUATE BLOOD GASES; NASOGASTRIC FEEDING HAD CEASED SIX HRS PRIOR. WITHIN THIRTY  MINUTES AFTER EXTUBATION/LMA REMOVAL THE PT DEVELOPED RESPIRATORY FAILURE AND WENT INTO RESPIRATORY ARREST. THE PT WAS ORALLY REINTUBATED AND OXYGENATION WAS RAPIDLY RESTORED. AT LARYNGOSCOPY MILD PHARYNGEAL EDEMA WAS NOTED AS WELL AS A SMALL AREA OF NECROSIS ON THE POSTERIOR WALL. THE PT WAS TREATED WITH STEROIDS AND DEBRIDEMENT VIA FIBEROPTIC SCOPE FOR 1 WEEK. A CHEST X-RAY TAKEN SHORTLY AFTER REINTUBATION REVEALED MARKED BILATERAL ATELECTASIS AND RIGHT UPPER LOBE CONSOLIDATION, PROBABLY SECONDARY TO ASPIRATION. AT THIS TIME THE X-RAYS WHICH HAD BEEN TAKEN DAILY PRIOR TO THE EXTUBATION WERE REVIEWED, AND IT WAS NOTICED THAT THE ENDOTRACHEAL TUBE HAD EXTRUDED SO THAT THE INFLATED ENDOTRACHEAL TUBE CUFF LAY INSIDE THE MASK OF THE LMA. THIS APPARENTLY OCCURRED FROM 6 TO 30 HRS PRIOR TO  EXTUBAION. THIS DEVELOPMENT HAD GONE UNNOTICED BY THE STAFF AND THE PT HAD MAINTAINED A SATISFACTORY AIRWAY. THE PT THEN RESPONDED WELL TO CONVENTIONAL THERAPY FOR ASPIRATION, BUT THEN TWO DAYS LATER PREMATURELY EXTUBATED HERSELF. ON THIS OCCASION FACE MASK VENTILATION WAS NOT EFFECTIVE AND TRACHEAL INTUBATION WAS IMPOSSIBLE. ALTHOUGH AN LMA WAS AVAILABLE, NO PERSONNEL SKILLED IN ITS USAGE WERE AVAILABLE, SO AN EMERGENCY TRACHEOSTOMY WAS PERFORMED. THE PT RECOVERED FROM HER MULTIPLE RESPIRATORY PROBLEMS AND WAS DISCHARGED TO THE WARD.
ON 7/15 AT 10:25, A PT DEVELOPED A SUDDEN ONSET OF VENTIRCULAR TACHYCARDIAC/VENTRICULAR FIBRILLATION. THE CARDIAC MONITORING DEVICE FAILED TO ALARM (A LEVEL ONE ALARM WHICH CAN NOT BE DISARMED). THE RN WATCHING THE MONITORS NOTED AND SUCCESSFULLY TREATED THE PT. HOWEVER, THE MONITOR FAILED TO ALARM, RECORD ONSET. IT FINALLY NOTED THE ARRHTHYMIA AFTER THE CODE WAS CALLED AND THE CODE TEAM ARRIVED ON THE SCENE. (THE DELAY OF ABOUT 2-3 MINUTES). THE MEMORY BANK PROVIDED STRIPS WHICH CLEARLY LABELED THE ARRHYTHMIAS CORRECTLY AND DEMONSTRATED THE ALARMS WERE DETCTING CORRECT3LY YET THE SYSTEM FAILED TO ALARM.
BALLOON EXPLODED. PIECES IN PT'S ABDOMEN; REMOVAL NECESSARY; IT DID NOT STAY IN TACT WHEN PUNCTURED BECAUSE IT DID NOT DECOMPRESS.
A 68 YR OLD MALE UNDER CPR BY BYSTANDER. THE PT'S CARDIAC MONITOR SHOWED VENTRICULAR FIBRILLATION. THE MONITOR DEFIBRILLATOR FAILED TO DELIVER A CHARGE. SEVERAL ATTEMPTS WERE MADE TO DELIVER A SHOCK WITHOUT SUCCESS. THE PT WAS SUBSEQUENTLY TAKEN TO CLOSEST EMERGENCY DEPARTMENT WHERE HE WAS DEFIBRILLATED ONTO A SINUS RHYTHM. AS OF TODAY 8/13/96 THE PT IS EXTUBATED AND HOSP IN THE INTENSIVE CARE UNIT.
UNABLE TO DEFLATE A 18FR CATHETER THAT HAD BEEN INSERTED 8/2/96. BALLOON HAD TO BE RUPTURED BY INSERTION OF ALCOHOL. POSSIBILITY THAT FRAGMENT OF CATHETER LEFT IN.
VENTILATOR MALFUNCTION. MACHINE DID NOT DELIVER SET TIDAL VOLUME (860CC SET, BUT DELIVERED ONLY 100-150).
PT HAD TRANSESOPHAGEAL ECHOCARDIOGRAM 5/21/96 WHICH REVEALED "ABNORAML PROSTHETIC VALVE WITH COMPLETE PARALYSIS OF ONE LEAFLET; WITH THE OTHER LEAFLET OPENING NORMALLY. EXTENSIVE DEGREE OF MITRAL STENOSIS PRESENT." PT HAD BEEN PROGRESSING WELL UNTIL A SHORT TIME BEFORE THIS PROCEDURE. RE-ADMITTED FOR REOPERATION OF MITRAL VALVE PROSTHESIS (WAS EXPLANTED AND REPLACED WITH 27M VALVE). FINDINGS AT TIME OF SURGERY: NO MOVEMENT POSTERIOR LEAFLET SECONDARY 2% TO THROMBUS. FAIRLY LARGE PANNUS FORMATION ON POSTERIOR RIM OF ANNULUS. CARDIAC DISCHARGE 7/31/96. POST OPERATIVE COMPLICATION. "IDIOPATHIC TONGUE WEAKNESS" POSSIBLY DUE TO BRAINSTEM STROKE. THIS MAY REQUIRE FOLLOW UP SPEECH THERAPY POST DISCHARGE.
THE PT HAS NOT RETURNED FOR FURTHER TREATMENT; THEREFORE, THE SITE HAS NO ADDITIONAL CLINICAL INFORMATION TO REPORT. AN INSERVICE WAS PERFORMED ON 07/25/96 AND NINE MASKS SUSPECTED OF BEING EXPOSED TO IMPROPER CLEANING AGENTS AND IMPROPER STERILIZATION TECHNIQUES WERE REMOVED. THE SITE HAS ALSO RECEIVED NEW MASKS AND IS NOW FOLLOWING PROPER CLEANING/ STERILIZATION PROCEDURES. THE SITE REPORTS THAT THEY HAVE NOT HAD ANY FURTHER PROBLEMS. THIS FILE IS CONSIDERED CLOSED UNLESS ANY ADDITIONAL INFO IS RECEIVED REGARDING THIS INCIDENT.
DURING BEGINNING PORTION OF LAPAROSCOPY, UPON INSERTION OF TROCAR, SUDDEN FORCEFUL BLEEDING NOTED. PT REQUIRED OPEN PROCEDURE TO CONTROL BLEEDING AND REPAIR ILIAC VEIN AND ARTERY PERFORATION.
A 83 YR OLD FEMALE FELL AND UNDERWENT RIGHT COMPRESSION HIP ON 12/3/95. ON 4/19/96 UNDERWENT REVISION OF RIGHT COMPRESSION HIP BECAUSE OF BROKEN SCREW.
PT WAS OUT ON 4 WHEELER AND FELT A POP IN HIS HIP WITH EXCRUCIATING PAIN. HE STRUGGLED BACK TO HOUSE AND RESCUE SQUAD WAS CALLED TO TRANSPORT TO THE HOSP. X-RAYS DEMONSTRATED A FRACTURED CERAMIC FEMORAL HEAD COMPONENT AND ACETABULAR CUP INSERT OF LT TOTAL HIP ARTHOROPLASTY WITH REMOVAL OF FRACTURED FEMORAL HEAD.
PT WAS VENTILATOR DEPENDENT SINCE 4/92. STAFF IN ROOM AT 11:10 PM GIVING AN IN-LINE TREATMENT AND VENTILATOR FUNCTIONING PROPERLY. AT 11:40 PM LAB TECH ENTERED ROOM AND FOUND VENTILATOR TUBING DISCONNECTED FROM TRACH AND RESTING 3-4" BELOW TRACH ON PT'S CHEST. NURSE SUMMONED IMMEDIATELY. NO HEART TONES. NO RESPIRATIONS. VENTILATOR ALARMS NOT SOUNDING. VENTILATOR CONTINUING TO CYCLE. STAFF OBSERVED VENTILATOR FOR 5 ADD'L MINUTES AND ALARM NEVER DID SOUND. NOTE: PT WAS A DO NOT RESUSCITATE.
RESIDENT WAS ON TROLLEY LIFT AND CNA HAD JUST COMPLETED BATH. SAFETY BELT WAS IN PLACE ON RESIDENT. CNA TURNED FROM RESIDENT TO PLACE PAD IN A GERI-CHAIR AND RESIDENT FELL OFF TROLLEY. CNA WAS LESS THAN 1 FOOT FROM RESIDENT. SAFETY BELT HAD POPPED OFF THE SECURING PEG. ON INVESTIGATION, SAFETY BELT SHOWED SOME WEAR AND CRACKING IN PLASTIC WHICH COULD HAVE CAUSED SOME SLACK CAUSING BELT TO POP OFF PEG. RESIDENT SUSTAINED A LACERATION AND HEMATOMA TO LEFT HEAD. CT SHOWED SOME BLEEDING INTER-CRANIALLY; HOWEVER, WAS NOT TRAUMATIC IN APPEARANCE AND WAS OLDER THAN TIME OF INCIDENT.
DURING L AXILLARY DISSECTION, PENCIL WOULD NOT WORK IN CUTTING MODE. DEVICE AVAILABLE FOR RETURN TO MFR FOR ANALYSIS. AS OF THE 96E LOT OF THIS DEVICE, CO QA SAID THAT MFG PROCESSES HAD BEEN CHANGED TO CORRECT PREVIOUS PROBLEMS WITH EXCESSIVE FORCE REQUIRED TO ACTIVATE BUTTONS ON PENCIL. THIS MAY BE ANOTHER OCCURRENCE OF THE PROBLEM IN A LOT MADE AFTER THE 96E LOT.
THERE WAS A HAIR IN A "STERI" PACK CAP USED FOR DRY RESERVOIR. THE CAP IS STERI PACKED THEN THIS "UNIT" IS CONTAINED WITH THE RESERVOIR IN ANOTHER STERI PACK.
PT WAS DRAWING UP INSULIN AND THE SYRINGE NEEDLE BROKE OFF IN THE BOTTLE. PT WAS CONCERNED THAT IT COULD HAVE BROKEN OFF WHILE INJECTING IT INTO HERSELF. PT ALSO MENTIONED THAT SHE HAD RECEIVED A CONTAMINATED SYRINGE ON A SEALED BAG EARLIER IN 1996.
SLOW GAS LEAK ALARM SOUNDED. CHECKED IABP TO FIND A SMALL AMOUNT OF BLOOD IN THE IABP CATHETER TUBING. WITHIN 5 MINUTES, THE BLOOD HAD FILLED THE ENTIRE CATHETER. THE IABP WAS PLACED ON STANDBY AND THE CATHETER WAS REMOVED WITHIN 10 MINUTES. THE CATHETER WAS FOUND TO HAVE A HOLE IN IT.
IABP CATHETER REMOVED AND FOUND TO HAVE A HOLE IN IT.
TWO IV SETS LEAKING AT THE BASE OF THE Y-SITE NEAREST THE SPIKE.
ONE IV SET LEAKING AT THE BASE OF THE Y-SITE NEAREST THE SPIKE.
STAFF MEMBER PREPARED TO CHANGE PARAFFIN IN THE TISSUE PROCESSOR. EXCESS PARAFFIN SPILLED OUT OF THE PROCESSOR SO STAFF SCRAPED IT WITH A METAL PARAFFIN KNIFE. WHEN THE METAL KNIFE CAME IN CONTACT WITH THE DRAIN PORT AND LOWER CHASSIS, ELECTRICITY ARCED FROM ONE COMPONENT TO THE OTHER. POWER RESISTOR ON THE DRAIN PORT WAS TOUCHING A LEAD ON THE KEYSWITCH, PUTTING 120 V AC ON THE TOP CHASSIS.
DURING CARDIAC RESUSCITATION AN "UNUSUAL NOISE" WAS HEARD WITH DEFIBRILLATOR DISCHARGE.
PT WAS ADMINISTERING IV MEDICATION, WHEN HER MEDICATION BEGAN LEAKING OUT. CAP REPLACED AND LEAKING CEASED. CAP WAS TIGHT AND CRACK IN THE CAP WAS PRESENT.
PT'S PICC CAP CRACKED ALLOWING FLUSH TO LEAK OUT OF PICC LINE, (AS WELL AS MEDICATION AND BLOOD).
MALFUNCTION OF NEEDLE TIP DURING TONSILLECTOMY. TIP PRODUCED FLAME. NO IMMEDIATE INJURIES TO PT, BUT HRS LATER THERE WAS REDNESS ON THE FACE.
CATHETER INSERTED IN PULMONARY ARTERY AND WOULD NOT MEASURE TEMPERATURE SENSITIVITY.
PT SLID OUT OF BOTTOM OF BED WHEN FOOTBOARD FAILED, ONTO FLOOR AND WENT INTO RESPIRATORY FAILURE. EMERGENCY TRACH WAS PERFORMED.
WHILE PERFORMING LARGE BOWEL ANASTAMOSIS FOLLOWING COLON RESECTION, THE  STAPLER WAS FIRED. AFTER REMOVAL IT BECAME APPARENT THAT NO STAPLES HAD BEEN IN THE STAPLER. A COLOSTOMY HAD TO BE PERFORMED AT THIS POINT DUE TO THE FACT THAT THE STAPLER WHICH CUTS AS IT STAPLES DID NOT LEAVE ENOUGH TISSUE TO ATTEMPT ANASTOMOSIS AGAIN. ADD'L 2 HRS SURGERY TIME AND SIGNIFICANT BLOOD LOSS.
DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS PLACED DISTAL TO THE STENT SITE IN A DIAGONAL BRANCH OF THE LEFT ANTERIOR DESECNDING CORONARY ARTERY. UPON INFLATION, THE BALLOON BURST AT 20 ATM. ATTEMPTS TO WITHDRAW THE BALLOON PAST THE STENT WERE NOT SUCCESSFUL. THE CATHETER WAS DRAWN BACK UNTIL THE BALLOON BROKE OFF. THE BALLOON WAS SURGICALLY REMOVED.
NISSEN-HILL FUNDOPLICATION PROCEDURE WAS PERFORMED FOR TREATMENT OF PAIN ASSOCIATED WITH GASTROINTESTINAL REFLEX, FAILURE TO THRIVE. EPIDURAL CATHETER INSERTED 1/9/96 WITHOUT DIFFICULTY. IT WAS NOTED THAT DOSE DELIVERED NIGHT OF 10/11/96 HAD NO EFFECT. CATHETER WAS REMOVED ON 10/12/96 AGAIN W/O DIFFICULTY BUT ABOUT 4 INCH SEGMENT REMAINED IN PT. REQUIRED SURGICAL REMOVAL. PHYSICIAN BELIEVES THAT CATHETER WAS FRACTURED PRIOR TO REMOVAL ATTEMPT. CATHETER IS PART OF CONTINUOUS EPIDURAL ANESTHESIA TRAY PRODUCT. INCLUDES 1 MARKED RADIOPAQUE TEFLON EPIDURAL CATHETER WITH STYLET.
PROCEDURE-RENAL STENT-SUCCESSFUL STENT PLACEMENT, RIGHT RENAL OSTIUM USING A SINGLE STENT AND A MAXIMUM OF A 9 MM X 2 CM CO BALLOON. PROCEDURE WAS COMPLICATED BY RUPTURE OF THE BALLOON WHICH MADE REMOVAL OF THE BALLOON IMPOSSIBLE. THE PT WAS REFERRED TO SURGERY FOR ELECTIVE VASCULAR REPAIR OF RIGHT GROIN AND REMOVAL OF REMAINING BALLOON FRAGMENT. AORTIC TO LEFT ABOVE KNEE POPLITEAL BYPASS GRAFTING. BALLOON RUPTURED AT 2 ATMS OF PRESSURE ON THE INITIAL INFLATION. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON INTO THE 8 FRENCH SHEATH WHICH PROVED IMPOSSIBLE AND IN FACT, IT CAME APART IN TWO PIECES DURING THE ATTEMPT TO REMOVE THE RUPTURED BALLOON CATHETER. CHRONIC RENAL INSUFFIENCY, INSULIN DEPENDENT, DIABETIC, HYPERTENSION.
ON 1/15/96 UNSUCCESSFUL ATTEMPT AT INSERTING SUBCLAVIAN DIALYSIS CATHETER. WHEN GUIDEWIRE REMOVED, IT WAS COILED IN RIGHT SUBCLAVIAN AND JUGULAR VEIN ON THE RIGHT. ON 1/16/96 FRAGMENTED GUIDEWIRE REMOVED FROM RIGHT INNOMINATE-RIGHT JUGULAR VEIN IN THE RADIOLOGY DEPARTMENT.
DURING A BONE MARROW BIOPSY PROCEDURE THE CATHETER BROKE OFF AT THE HANDLE. PT WENT TO THE OPERATING ROOM FOR REMOVAL OF FOREIGN BODY FROM THE ILIAC CREST. THE MD STATES THAT WHEN HE TURNED THE HANDLE DURING THE BIOPSY, THE HANDLE BECAME STRIPPED FROM THE CATHETER. THE HANDLE WOULD TURN BUT NOT THE NEEDLE.
PT DEVELOPED NAUSEA, VOMITING, SHORTNESS OF BREATH AND BRADYCARDIA AFTER CATHETER INSERTED. FIRST SYMPTOM APPEARED WITHIN FIVE MINUTES OF INSERTION. OXYGEN SATURATION LEVEL DROPPED FROM 98-99%  TO 80%. CATHETER INSERTION WAS UNEVENTFUL. THE CATHETER WAS REMOVED. THE PT RECEIVED NEBULIZATION TREATMENTS, HAD SUPPLEMENTAL OXYGEN INCREASED AND RECEIVED INTRAVENOUS BENADRYL. SYMPTOMS COMPLETELY RESOLVED.
HAND HELD ELECTROSURGICAL PENCIL WAS SET FOR OPERATIVE PROCEDDURE. WHEN CORD FROM PENCIL WAS PLUGGED INTO THE ESU, IT SELF ACTIVATED. THE PT SUSTAINED A SMALL BURN ON THE INNER ASPECT OF LEFT ANKLE WHICH WAS EXCISED AND CLOSED. WHEN PENCIL EVALUATED BY BIOMED DEPARTMENT, THE COAG SWITCH WAS STUCK IN THE DEPRESSED POSITION. THE ESU WAS EVALUATED AND NO PROBLEM WAS FOUND.
PT COMPLAINED OF PAIN IN RIGHT BREAST. HOLE WAS FOUND IN PROSTHESIS.
DIFFICULTY IN PROGRAMMING WAS ENCOUNTERED SINCE THE TIME OF IMPLANTATION. COCHLEAR IMPLANT HAS MONOPHASIC OUTPUT RATHER THAN BIPHASIC OUTPUT.
PUMP WAS IMPLANTED ON 2/15/96. MALFUNCTION. THE MAIN CHAMBER WOULD NOT DISPENSE FLUID AND THE SIDE PORT WOULD NOT WORK.
PT HAD LVAD INSERTED ON 1/17/96 BECAUSE OF LV FAILURE. ON 3/21/96, PT SAT UP IN BED AND LOW FLOW ALARM SOUNDED. NORMALIZED ON RETURN TO BED. SAT UP MOMENTS LATER AND LOW FLOW ALARM SOUNDED WITH SEROUS FLUID NOTED IN INTERCONNECT CABLE. PT TAKEN TO OR WHERE LEAKING LVAD EXPLANTED AND NEW LVAD IMPLANTED.
INTRA-AORTIC BALLOON WAS INSERTED ON 4/2/96 AND FUNCTIONED NORMALLY UP UNTIL THE AFTERNOON OF 4/3/96. THE ALARM SOUNDED AND BLOOD WAS NOTED IN IAB CATHETER. THE DECISION WAS MADE TO REMOVE THE BALLOON SURGICALLY UNDER DIRECT VISUALIZATION. NO COMPLICATIONS WITH THE REMOVAL.
DURING ATTEMPT TO HARVEST SPLIT THICKNESS SKIN GRAFT OF RIGHT THIGH, PT SUSTAINED 8CM X 3CM LACERATION. LACERATION REQUIRED SUTURES AND STAPLES.
PT 40+ WEEKS IN ACTIVE LABOR. UPON INSERTION OF DEVICE, THERE WAS A DECREASE IN B/P INTO THE 50'S. THERE WAS A LARGE AMOUNT OF VAGINAL BLEEDING. AN EMERGENCY C-SECTION WAS PERFORMED WITH FETAL DEMISE.
PT WAS 40+ WEEKS IN ACTIVE LABOR. DEVICE WAS INSERTED. IT DID NOT FUNCTION PROPERLY AND MONITORING WAS INADEQUATE. IT WAS REMOVED.
PT WAS TAKEN TO BATHROOM BY AIDES AND SAT ON SHOWER CHAIR. THE WHEEL ON THE SHOWER CHAIR CAME OFF CAUSING PT TO FALL. PT HAS BILATERAL AMPUTATIONS. WHEN SHE FELL FROM CHAIR SHE LANDED ON LEFT STUMP AND FRACTURED HER FEMUR.
LAPAROSCOPC ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGOOPHERECTOMY, POSTERIOR REPAIR, CULDOPLASTY. POST OPERATIVELY DEVELOPED SIGNS OF SHOCK WITH 7 MG DROP IN HGB. BLEED APPARENTLY CLOTTED SPONTANEOUSLY. 2 WEEKS PO HAD EVAC BY NEEDLE ASPIRATION OF HEMATOMA.
PT WAS IN HOSP FOR CATARACT REMOVAL AND INSERTION OF POSTERIOR CHAMBER LENS. WHEN LENS WAS EJECTED FROM ITS CARTRIDGE, THE LENS TORE AND ONLY HALF OF LENS WENT INTO EYE. THIS NECESSITATED ADD'L SURGICAL INTERVENTION TO REMOVE THE LENS.
SURGEON WANTED TO TAKE A SPLIT THICKNESS SKIN GRAFT ON RIGHT THIGH. THE DERMATOME TOOK A FULL THICKNESS SKIN GRAFT ON THE RIGHT THIGH EVEN THOUGH IT WAS NOT SET TO TAKE A FULL THICKNESS.
PICC CATHETER PLACED AT ANOTHER SITE. IN THE ATTEMPT TO PULL THE LINE IT BROKE, LEAVING 2-3" IN PT ARM. PT APPLIED PRESSURE PER MD AND WAS TRANSPORTED TO MD OFFICE AND THEN SENT TO ER FOR REMOVAL. PT WAS NEUTROPENIC AND DEVELOPED AN INFECTION NECESSITATING AN ADMISSION FOR SEVERAL DAYS TO TREAT INFECTION.
A BLACK FIBER FOREIGN OBJECT ABOUT 1/8" LONG IS IN THE LUMEN OF THE "TAIL" PIECE OF PLASTIC TUBING. THE FOREIGN OBJECT CAN BE MADE TO MOVE BY STOPPING THE UNIT.
PRODUCT NOT DISINFECTING INSTRUMENTS. SPREAD OF STAPH, WARTS, AND ATHLETES FEET.
CONSUMER REPORTED THAT HE FOUND 1 LIVE AND 1 DEAD LARVAE IN A BOX CONTAINING PACKAGES OF ADULT-SIZED DIAPERS AND RUBBER GLOVES. THE DISTRIBUTOR CO USUALLY DELIVERS THEM TO HIS WORK SITE. HOWEVER, ON HIS LAST ORDER, THE CO MAILED THEM. THE BOX SAT IN THE POST OFFICE FOR 6 DAYS PRIOR TO HIS PICKING IT UP. WHEN HE OPENED THE BOX, (WHICH CONTAINED TWO PERFORATED BAGS OF DIAPERS) AND 2 BOXES OF RUBBER GLOVES), HE FOUND 1 LIVE AND 1 DEAD LARVAE IN THE SHIPPING BOX. HE HAS NOT FOUND ANY WORMS YET IN THE BAGS OF DIAPERS, NOR RUBBER GLOVES. CONSUMER REPORTED THAT HE TOOK THE LARVAE TO THE DEPT OF AGRICULTURE OFFICE WHERE THEY WILL BE ANALYZED. THE MFR REPORTS THAT THERE HAVE BEEN A TOTAL OF 4 COMPLAINTS OF BUGS IN THE LAST 12 MONTHS. CO SPOKE WITH PERSONNEL AT THE PLANT THIS MORNING AND WAS TOLD THAT THE PEST CONTROL RECORDS WERE REVIEWED AND ONLY ONE REPORT HAD BEEN FILED. IT WAS A REPORT OF CRICKET ACTIVITY AT THE RECEIVING DOCK. NONE OF THE FOUR COMPLAINTS WERE RELATED TO ANY ONE SPECIIC LOT NUMBER.
ON 1/7/94, SUTURE WAS USED TO CLOSE THE FASCIA DURING A CESAREAN DELIVERY. AN EVISCERATION WAS DIAGNOSED ON POST-OPERATIVE DAY SEVEN. AT THE TIME OF REEXPLORATION, THE SUTURE WAS NOTED TO HAVE FAILED.
COMPLETE WEAR THROUGH OF PATELLA POLY LEADING TO DISASSOCIATION FROM METAL BACK. DELAMINATION OF TIBIAL POLY. REPLACED TIBIAL INSERT AND PATELLA.
A 76 YR OLD FEMALE, OSTEOARTHRITIS PT FELL TWO TIMES AND CUP LOOSENED. IMPANTED IN 1994. RETAINED BY HOSP.
RPTR USES THESE BAGS FOR SYRINGES. AREA NONSTERILE DUST COVERING INSIDE THE BAG THERE WAS AN INSECT.
MESH WAS USED DURING COLPOSACROPEXY AND PELVIC FLOOR REPAIR. 10 DAYS LATER AFTER CONTINUED HOSPITALIZATION, PT WAS REOPERATED ON FOR BOWEL ADHESION NUMBERS IN THE AREA.
SILICONE INTRAOCULAR LENSES ARE FOLDABLE LENSES BEING USED IN CATARACT SURGERY. ONE OF THE PRIMARY CAUSES OF RETINAL DETACHMENT IS PREVIOUS CATARACT SURGERY AND SUBSEQUENT LASER (YAG) CAPSULOTOMY. IN THE REPAIR OF A DETACHED RETINA, A SURGEON OFTEN PERFORMS A VITRECTOMY WITH FLUID AIR EXCHANGE. SILICONE INTRAOCULAR LENSES BECOME "FOGGY" DURING THE EXCHANGE AND THE SURGEON CANNOT SEE THROUGH THE LENS IMPLANT. IN ADDITION, SILICONE OIL IS SOMETIMES USED IN REPAIR OF COMPLEX DETACHMENTS AND THE OIL IS INCOMPATIBLE WITH THE SILICONE LENS. THIS IS GOING TO BECOME A GREATER PROBLEM FOR RETINAL SURGEONS AS MORE OF THESE LENSES ARE USED. RPTR THINKS THE FDA SHOULD CONSIDER DISALLOWING THE USE OF THESE LENSES IN CATARACT SURGERY. IN ADDITION, PTS WITH MACULAR HOLES REQUIRE FLUID AIR EXCHANGE TO REPAIR THE HOLE AND PTS WITH SILICONE IOLS AND OPEN POSTERIOR CAPSULES PRESENT A PROBLEM.
SECOND DEGREE BURN, SUSTAINED BY A DIABETIC PT, ON THEIR FOOT DUE TO HEATING BLANKET USED BRIEFLY IN DR'S OFFICE TO WARM FOOT PRIOR TO NERVE CONDUCTION STUDIES.
PT IS A HOME CARE TPN USER. IN HER SUPPLIES ARE CO'S 21G, 1" NEEDLES, WHEN ADMINSTERING A FLUSH THIS AM, (1) NEEDKE WAS FOUND TO HAVE A CONTAMINANT INSIDE THE NEEDLE SHEATH AND HUB, ALL INSIDE THE STERILE WRAPPER. THE CONTAMINANT APPEARED, TO THE PT, TO BE DRIED BLOOD. THIS WAS THE ONLY NEEDLE FOUND TO BE CONTAMINATED.
ACQUIRED CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEURAPATHY. SEVERE SENSORY, MOTOR AND AUTONOMIC NERVE DAMAGE. SYMPTOMS OBVIOUS BY 4/94; DIAGNOSED 11/94. LOT NUMBER IS UNREADABLE AFTER "HH".
SPILLAGE OR CONDENSATION DRIPPED ONTO MAIN POWER FEED LUG ON BACK OF MAIN POWER SWITCH. THIS EITHER DIRECTLY STARTED OVERHEAT3ING THAT CONNECTION OR OVER TIME CORRODED CASUING IMPEDENCE OF CONNECTION TO INCREASE AND THEREBY CAUSING OVERHEATING OF CONNECTION. CO NOW SENDS SPLASH COVER WITH SWITCH, BUT MAY NOT HELP IF THERE IS INTERNAL CONDENSATION. THIS IS SECOND POWER SWITCH REPLACED WITH THIS FAULT.
ON 8/9/94 RPTR WENT IN FOR MRI SCAN. RPTR WAS GIVEN A PAIR OF HEAD-PHONES WITH MUSIC PLAYING; NOT GIVEN EAR PLUGS. THE MRI TESTING WAS EXTREMELY LOUD, CONTINUOUSLY, AND HAD AN EAR PIERCING SOUND THAT HAPPENED AT REGULAR INTERVALS, IT LASTED FOR 34 MINUTES. RPTR COULD NOT HEAR THE MUSIC BECAUSE THE MACHINE WAS SO LOUD. UPON EXITING THE MACHINE, RPTR TOLD THE TECH THAT IT WAS VERY LOUD, AND SHE SAID MY HEAD WAS AT THE LOUDEST PART OF THE MACHINE AS RPTR STARTED TO WALK, SHE COULD FEEL A VIBRATION IN HER HEAD, EXTREME HEADACHE, DIZZINESS, NAUSEA, AND A PLUGGED FEELING IN BOTH EARS. THIS FEELING OF FULLNESS, LOSS OF HEARING ACUITY, AND OCCASIONAL PAIN LASTED UNTIL 8/31/94, AT WHICH TIME RPTR EXPERIENCED A SENSITIVITY TO EVERYDAY LOUD SOUNDS CALLED HYPERACUSIS. IT WAS ACCOMPANIED BY A HIGH PITCH RINGING SOUND IN BOTH EARS, CALLED TINNITUS, BY MID 11/94. RPTR STILL HAS  TINNITUS AT 5000 HERTZ, AND IS HEARING SOUNDS 10 TO 20 DECIBELS LOUDER THAN THE AVERAGE PERSON. RPTR IS A 38 Y/O FEMALE, WHO HAS BEEN FORCED TO WEAR EAR PROTECTION MUCH OF THE TIME.
WHEN RPTR INTRODUCED COMBINATION BLOOD GAS AND ELECTROLYTE INSTRUMENTS FOR STAT OR TESTING, LAB NOTED THAT INSTRUMENTS USES A CONDUCTANCE METHOD TO DETERMINE HEMATOCRIT AND THAT CONDUCTANCE HEMATOCRITS ARE BIASED 0.3% HIGH WHEN COMPARED TO SPUN HEMATOCRITS. RPTR DEBATED AT THE TIME WHETHER OR NOT TO REPORT THE CONDUCTANCE VALUE, AND DECIDED TO SEND THE RESULT LABELED AS "HEMATOCRIT, CONDUCTANCE" TO DISTINGUISH IT FROM A HEMATOCRIT DERIVED FROM A CBC OR BY CENTRIFUGATION. THIS HAS GENERALLY NOT BEEN A PROBLEM, SINCE THE DIFFERENCES ARE USUALLY NOT VERY LARGE. THERE IS SOME EVIDENCE THAT IN THE FACE OF SEVERE HEMODILUTION CONDUCTANCE-BASED ESTIMATES OF HEMATOCRIT MAY BE MORE UNRELIABLE THAN USUAL. HOWEVER, RPTR HAS A MODERATE AMOUNT OF DATA SUGGESTING THAT THE RECOGNIZED BIAS OF RESULTS VARIES RELATIVELY LITTLE WITH CHANGING HEMATOCRIT, PERHAPS BECAUSE THE INSTRUMENT CONTAINS SOME CIRCUITRY WHICH ATTEMPTS TO CORRECT FOR LOWER HEMATOCRIT VALUES. THE BIAS DOES SEEM TO VARY SIGNIFICANTLY AMONG DIFFERENT PTS, BUT APPEARS TO BE FAIRLY CONSISTENT WITHIN A GIVEN INDIVIDUAL. RPTR RECENTLY HAD COMPLAINT OF A MUCH WIDER DISCREPANCY-NEARLY 10% BETWEEN A CONDUCTANCE HEMATOCRIT AND A SPUN HEMATOCRIT WHICH IS VERY DISCONCERTING, AND SUGGESTS THE NEED TO REVIEW THIS ISSUE, PARTICULARLY BECAUSE LARGE DISCREPANCIES HAVE SEEMED RATHER ERRATIC. PERHAPS THERE IS SOME OTHER UNRECOGNIZED METHODOLOGIC PROBLEM, E.G.,,SETTLING DIFFERENCE OF THE RBCS AND REMIXING OF THE ANTICOAGULANT SAMPLES. BECAUSE CONDUCTIVITY MEASUREMENT IS DEPENDENT UPON ELECTROLYTE CONCENTRATIONS AND THE VOLUME OF SOLUTION BETWEEN TWO ELECTRODES, ANY VARIATION IN THE ELECTROLYTE CONCENTRATION MAY ALSO AFFECT THE HEMATOCRIT VALUE IF NOT TAKEN INTO CONSIDERATION. SOME ANALYZERS THAT SIMULTANEOUSLY MEASURE CONCENTRATIONS OF SODIUM AND POTASSIUM ALONG WITH HEMATOCRIT (CONDUCTIVITY) MAY USE SODIUM AND POTASSIUM VALUES TO CORRECT FOR VARIATIONS THAT MAY BE CAUSED BY THOSE ANALYTES. CHANGES IN OTHER ELECTROLYTE CONCENTRATIONS, HOWEVER, MAY NOT BE TAKEN INTO ACCOUNT. THIS MAY BE OF PARTICULAR IMPORTANCE WHEN MEASUREMENTS ARE MADE ON SPECIMENS TAKEN FROM PTS UNDERGOING HEMODILUTION (I.E., CARDIAC SURGERY). AS CELL VOLUME IS REDUCED BY DILUTION WITH A SPECIAL SOLUTION (CARDIOPLEGIA), THE ELECTROLYTES AND THEIR CONCENTRATIONS MAY VARY DEPENDING UPON THE ELECTROLYTES AND THEIR CONCENTRATIONS IN CARDIOPLEGIA SOLUTION. THE CONSTITUENTS OF THESE SOLUTIONS MAY VARY NOT ONLY FROM INSTITUTION TO INSTITUTION BUT FROM PHYSICIAN TO PHYSICIAN. RPTR DOES NOT BELIEVE THAT THE PROBLEM IS DEVICE OR VENDOR-DEPENDENT , BUT BELIEVES IT IS INHERENT IN THE  USE OF CONDUCTANCE TO MEASURE HEMATOCRIT. RPTR HAS NOT BEEN ABLE TO IDENTIFY THE SOURCE OF THE PROBLEM, BUT IT IS REAL. (*).
UPON INTRODUCING THE NEEDLE INTO THE BUFF CAP TO FLUSH A CENTRAL LINE, THE RUBBER STOPPER BECAME DISLODGED.
GENERATOR WAS REMOVED PER PT'S REQUEST BECAUSE IT WAS NOT WORKING. NO INJURY TO PT.
MEDICATION RESERVOIR WAS BEING CLEANED IN THE PT'S HOME BY AN AGENCY RN. RN ATTEMPTED TO RESTART PAIN MANAGEMENT PROGRAM BY TURNING PUMP ON. ON/OFF BUTTON FAILED AND LOCKED UP. A REPLACEMENT PUMP WAS OBTAINED FROM THE DISTRIBUTOR. PT WAS RESTARTED ON PAIN CONTROL WITHIN 2 HRS OF REPORTED PROBLEM.
STAPLER WOULD NOT LOCK AFTER FIRING. SURGEON HAD TO CLOSE USING REGULAR SUTURE.
PT HAD AN AUTO ACCIDENT 9/91 WITH RESULTING LEG DEFORMITY. 6/13/96-TISSUE EXPANDER INSERTION X2 RT MEDIAL AND LATERAL CALF. 7/19/96-REMOVAL OF TISSUE EXPANDERS AND INSERTIONS OF CUSTOM MADE SILICONE PROSTHESIS. 7/30/96- DRAINAGE AND BLISTERING OF AREA. STARTED ON KEFLEX. 8/3/96-CHANGED TO CIPRO. 8/5/96-REMOVAL OF INFECTED RT LEG IMPLANT WITHOUT DEBRIDEMENT OF SKIN AND SUB-Q TISSUE.
4/20/95-CHEST WALL RECONSTRUCTION WITH CUSTOM SILICONE IMPLANT. 5/19/95-REVISION OF CHEST WALL IMPLANT. 8/9/96-REMOVAL OF INFECTED CHEST WALL IMPLANT WITH ASSOCIATED CAPSULECTOMY. APPARENTLY PT FELL AND DISLODGED IMPLANT WITH SUBSEQUENT INFECTION.
TPN BAG SPLIT IN SHIPMENT. SAME PROBLEM NOTED ON TWO SEPARATE SHIPMENTS ON SAME DAY.
TPN BAG SPLIT IN SHIPMENT. SAME PROBLEM NOTED ON TWO SEPARATE SHIPMENTS THAT DAY.
PLASTIC PIECES NOTED IN OPERATIVE FIELD USING DISPOSABLE CONVERTER. PIECES CONSISTENT WITH PORT VALVE BUT DEFECT IN PORT NOT IDENTIFIED.
WHILE PERFORMING SKIN CLOSURE DURING SURGICAL REPAIR OF FRACTURE/DISLOCATION OF LEFT HALLUX, SUTURE NEEDLE TIP, APPROX. 1/16" LONG, NOTED TO BE BROKEN OFF AND MISSING. X-RAY NEGATIVE FOR PRESENCE OF FOREIGN BODY.
FLEX TUBE BECAME DISCONNECTED FROM VENTILATOR T AT "WYE" CONNECTOR. HAPPENED ON FIVE DIFFERENT OCCASIONS TO FIVE DIFFERENT PTS.
FLEX TUBE BECAME DISCONNECTED FROM VENTILATOR AT "WYE" CONNECTOR. HAPPENED ON FIVE DIFFERENT OCCASSIONS TO FIVE DIFFERENT PTS.
A RN WAS GOING TO FINAL DISPOSE OF A FULL SHARPS CONTAINER AND AS SHE REACHED HER HAND AROUND THE CONTAINER TO PICK IT UP, SHE REPORTEDLY RECEIVED A NEEDLESTICK FROM A NEEDLE ATTACHED TO A 3CC SYRINGE THAT HAD PROTRUDED THROUGH THE SIDE OF THE CONTAINER.
METHOD: DEVICE DISCARDED. REPORTER DECLINED ON-SITE VISIT. LOT CODE SPECIFIC INFO NOT AVAILABLE. RESULTS/CONCLUSIONS: REPORTED EVENT NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN USUAL FOR THIS PRODUCT.
FLEX TUBE BECAME DISCONNECTED FROM VENTILATOR AT "WYE" CONNECTOR. HAPPENED ON FIVE DIFFERENT OCCASIONS TO FIVE DIFFERENT PTS.
TUBE WAS PLACED SUCCESSFULLY IN THE PT ON 7/1/96. THE PT DEVELOPED DIFFUSE PERITONITIS AND WAS TAKEN TO SURGERY ON 7/15/96. THE PT UNDERWENT EXPLORATORY LAPORATOMY WHERE THE SURGEON NOTED JEJUNUM EROSION AND THE JEJUNAL TUBE WAS PROTRUDING INTO THE PERITONEUM. THE TUBE WAS REMOVED AND THE PT IS IN SATISFACTORY CONDITION.
THIS REPORT IS BASED ENTIRELY ON UNCONFIRMED INFO SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENDED TO BE AN ADMISSION THAT ANY CO DEVICE (I) IS DEFECTIVE OR MALFUNCTIONED OR (II) CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. CO DOES NOT BELIEVE THAT THIS REPORTED INCIDENT IS LIKELY TO REOCCUR.
RPTR COMPLAINED OF FEVER OF 101, SEVERE PAIN, ANXIETY AND OR DEPRESSION, SHORT-TERM MEMORY LOSS, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, HEAT OR COLD SENSITIVITY IN EXTREMITIES, FREQUENT LOW GRADE FEVER, FREQUENT MIGRAINES/SEVERE HEADACHES, HYPERSENSITIVITY TO CHEMICALS, MOLDS, DUST, OR POLLEN, MYOSITIS OR POLYMYOSITIS, SUN SENSITIVITY, CHRONIC FATIGUE SYNDROME, AND CLUMSINESS. IMPLANTED 6/20/86, EXPLANTED 1/19/95.
STENT WAS PLACED SUCCESSFULLY ON 1/11/96. SEVEN MONTHS LATER, THE PT EXPERIENCED CHEST PAIN AND INCREASED MUCUS. ON 8/15/96, THE PHYSICIAN PERFORMED AN ENDOSCOPY AND NOTED THE STENT APPEARED DEFORMED. THE PHYSICIAN OPTED TO PUSH THE STENT INTO THE STOMACH. A SNARE WAS USED TO RETRIEVE THE STENT; HOWEVER, A PORTION WAS REMOVED. FURTHER STENT REMOVAL WITH A SNARE WAS TERMINATED DUE TO POTENTIAL INJURY FROM THE SHEARED WIRES. THE PT WAS TAKEN TO SURGERY WHERE A GASTROSTOMY WAS PERFORMED AND THE STENT PIECES WERE REMOVED SUCCESSFULLY.
DURING PLACEMENT OF CVP CATHETER, GUIDEWIRE BEGAN TO UNRAVEL WHEN MD STARTED TO REMOVE IT.
THE EXTENSION TUBING DISCONNECTED FROM THE VALVE. THE USER REVERSED THE DIRECTION OF THE VALVE WHEN RECONNECTING THE TUBING RESULTING IN A TENSION PNEUMOTHORAX. THE PT RECOVERED WITHOUT FURTHER COMPLICATIONS.
MFR CONTROL NO. DC96-497. NOTE: THE DIRECTION OF FLOW IS MARKED WITH AN ARROW ON THE VALVE TO PREVENT REVERSING THE DIRECTION OF FLOW DURING USE.
ON 7/17/96 DENTIST WAS REMOVING THE SECOND OF THREE IMPACTED WISDOM TEETH, WHEN THE END CAP BLEW OFF THE HANDPIECE ALONG WITH THE TURBINE (WITH BUR) AND WASHER. WASHER AND TURBINE WERE RETRIEVED FROM POSTERIOR PHARYNX, BUT END CAP WAS NO WHERE TO BE FOUND. BECAUSE OF BILATERAL MANDIBULAR BLOCKS, PT DID NOT REALIZE SHE HAD SWALLOWED THE END CAP. RADIOGRAPH OF NECK AND CHEST REVEALED END CAP IN THE DISTAL STOMACH. THIS HANDPIECE IS USED INTERMITTENTLY AND WAS LAST SERVICED BY THE MFR SEVERAL YEARS AGO.
THE GLOVES SNAPPED UPON REMOVAL AND THE RPTR INHALED THE LATEX POWDER. SUBSEQUENTLY, THE RPTR DEVELOPED RESPIRATORY DISTRESS AND STRIDOR FOR WHICH SHE RECEIVED IV BENADRYL, SUB-Q EPINEPHRINE, O2 AND AN UNKNOWN NEBULIZER TREATMENT. RAST TEST WAS 35 AND RPTR WAS DIAGNOSED AS LATEX SENSITIVE BY TWO MDS.
WHEN REMOVING THE STYLET FROM AN ENDOTRACHEAL TUBE IT WAS NOTED THAT PART OF THE COVER WAS MISSING. THIS WAS RETRIEVED FROM THE TUBE WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PT.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRSSED IN THE DEVICE LABELING? N. SEVERITY GREATER FOR THIS EVENT THAN IS USUAL?  U.
RPTR EXPERIENCED EPISODES OF SEVERE BLEEDING INTO BLADDER (LOSS OF UP TO 5 UNITS OVER A PERIOD OF DAYS) CAUSED BY URETHRAL CATHETERS USED FOR INTERMITTENT BLADDER DRAINAGE MADE NECESSARY BY AN ENLARGED PROSTATE. OTHER EPISODES HAVE RESULTED IN MINOR BLEEDING LASTING LESS THAN 24 HRS. INJURIES THAT RESULT IN BLEEDING ARE CAUSED BY CUTTING ACTION OF SHARP, ROUGH DRAINAGE EYELETS ON CATHETERS DURING INSERTION AND/OR WITHDRAWAL. VERY FEW OF CATHETERS EXAMINED AND/OR USED (FROM OVER 25 DIFFERENT PRODUCTION LOTS) MET THE FRAUDULENT MARKETING CLAIMS OF THE MFR THAT BALLOONS WERE CENTERED. WHEN INFLATED, VIRTUALLY ALL BALLOONS WERE FAR OFF-CENTER, CAUSING FAILURE TO SEAT PROPERLY IN BLADDER NECK, INTENSIFYING BLEEDING. BALLOONS BEING OFF-CENTER CAUSES CATHETER TIPS TO PROJECT AT ANGLES OF 15+ DEGREES FROM TUBES WHICH CAN CAUSE ADD'L WOUNDING, PROLONG BLEEDING, AND CAUSE EXTREME PAIN AND DISCOMFORT. (*).
USER STATES THAT AFTER WATERING HIS LAWN, WENT INTO HIS HOUSE NOT REALIZING THAT A SPRINKLER HAD OVER FLOWN INTO KITCHEN, SLIPPED AND FELL. HE LANDED ON CUFF OF FOREARM CRUTCHES. USER SUFFERS FROM A BROKEN COLLAR BONE, AND 7 BROKEN RIBS.
EVENT FREQUENCY & SEVERITY; FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NOT THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
MEDICAL ATTENTION WAS REQUIRED AFTER EXPERIENCING FIBER SEPARATION.
510K #912002, 1 PERSON, SERIOUS INJURY, TYPE G. FREQUENCY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
PT WAS SITTING ON CHAIR OF HOIST ABOVE BATH. ONE MOMENT SHE WAS LIFTED DOWNWARDS. TWO BOLTS WERE BROKEN SUDDENLY (ON THE LIFTING ARM). PT FELL BACKWARDS IN THE WATER. SMALL BRUISES WERE SUSTAINED, NOT SEVERE.
HOIST WAS RETURNED TO GLOUCESTER FOR EXAMINATION. TWO OF THE THREE SCREWS WHICH RETAIN THE JIB TO THE BSQ ARM WERE BROKEN. THERE WAS NO SIGNS OF THE PAPER JOINT GASKET WHICH SHOULD HAVE BEEN PRESENT. SCREWS WERE REPLACED WITH THE ELECTRO-PHORETIC TYPE & A NEW PAPER GASKET WAS FITTED. THE HOIST HAS NOW BEEN REPAIRED, IT HAS BEEN LOAD TESTED & RETURNED. CAUSE WAS ATTRIBUTED TO MAINTENANCE ERROR ON PART OF USER. USER HAS BEEN INSTRUCTED TO REVIEW THE OPERATIONAL AND MAINTENANCE MANUAL.
AUTO MODE FAILED DURING BY-PASS. THE PERFUSIONIST SWITCHED TO MANUAL MODE PUMP STILL IN-OP. PERFUSIONIST CYCLED POWER ON/OFF, PUMP WORKED ONLY IN MANUAL MODE. PERFUSIONIST CONTINUED TO USE PUMP UNTIL PT EXPIRED. CO REP REPLACED A/D CONVERTER BOARD RETURNED PUMP BACK IN SERVICE.
CHRONIC INFLAMMATION-LENS POSITION 12-6, PUPIL UNDRAWN WITH VITREOUS TO WOUND, OCCASIONAL CELL AND VITREOUS HAZE. IOL WAS IMPLANTED ELSEWHERE.
PT RETURNED TO SURGERY POST TOTAL VAGINAL HYSTERECTOMY BECAUSE OF 6 GM DROP IN HGB AND SIGNS OF SHOCK. DISCOVERED DURING RE-OPERATION THAT PT WAS BLEEDING FROM UTERINE ARTERY EVENT THOUGH IT HAD BEEN STAPLED WITH CO INSTRUMENT. SURGEON NOTED AREAS AT STAPLE SITES WERE PUMPING BLOOD.
THE DEVICE WAS PLACED ON 7/19/96 IN A CVA (CEREBRAL ACCIDENT VICTIM) PT. ON 7/26/96, THE PT EXPERIENCED GI BLEEDING. AN ENDOSCOPY WAS PERFORMED AND IT WAS NOTED THE INTERNAL BOLSTER HAD ERODED INTO THE ABDOMINAL WALL AND HAD MADE AN ULCERATION. A BLEEDING ULCERATED AREA AT THE SITE OF EROSION WAS NOTED. THE FEEDING TUBE WAS REMOVED ENDOSCOPICALLY. A G-TUBE WAS PLACED AND THE BALLOON WAS USED TO TAMPONADE THE BLEED. THE PT'S CONDITION AFTERWARDS WAS REPORTEDLY GOOD. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. AGE AT TIME OF EVENT LISTED AS 65-68.
CO RECEIVED TWO MDR REPORTS FROM CO DISTRIBUTOR CONCERNING THE SAME SIZE AND TYPE OF DEVICE. THESE EVENTS OCCURRED AT THE SAME HOSP IN TWO VERY SIMILAR PTS. CO HAS NOT RECEIVED ANY PREVIOUS COMPLAINTS OF THIS NATURE ON THIS PARTICULAR PRODUCT. THE ACTUAL PERCENTAGE OF OCCURRENCE IS LESS THAN ONE HALF OF ONE PERCENT.
DR EXPLANTED FEMORAL COMPONENT DUE TO PROGRESSIVE PAIN IN THE SHAFT OF THE RIGHT FEMUR; X-RAY SHOWED OSTEOLYSIS OF THE RIGHT FEMUR. THE SURGEON BELIEVED THAT THE COMPONENT PLACED IN 1987 WAS "WEARING FAIRLY EARLY" AND NEEDED TO BE REPLACED BY A COMPONENT WITH A CEMENTED BRIDGE TYPE HIP.
REMOVAL OF NONFUNCTIONING PENILE PROSTHESIS.
THIS 41 YR OLD FEMALE UNDERWENT A BMA WITH IMPLANT INSERTION 5 YRS AGO AT ANOTHER FACILITY, THUS THE MFR OF THE IMPLANTS IS UNKNOWN TO THIS REPORTING FACILITY. THE PRE-OPERATIVE DIAGNOSIS FOR THIS LADY WAS MECHANICAL DEFLATION OF THE LEFT IMPLANT. GROSS EXAM: THE RIGHT IMPLANT IS INTACT. THE LEFT IMPLANT IS DEFLATED, WEIGHING 34 GM. AN ACTUAL PERFORATION IS NOT INDENTIFIED.
PT HAD IMPLANTABLE CATHETER IMPLANTED AT ANOTHER FACILITY. CATHETER "LIMB" WAS NOTED TO HAVE SHEARED OFF, THUS WAS RETRIEVED VIA FEMORAL VEIN AT THIS FACILITY. REPORTEDLY, BODY OF DEVICE WAS REMOVED AT HOSP SEVERAL DAYS LATER. ACTUAL MFR, LOT #, DEVICE #, IMPLANTATION DATE, ETC. NOT AVAILABLE TO THIS FACILITY.
RESIDENT FELT WEAK WHILE BEING MOVED FROM CHAIR TO BED VIA LIFT. THE TWO STAFF WHO WERE TRANSFERING RESIDENT WERE UNABLE TO PREVENT RESIDENT FROM SLIDING OUT OF THE SLING SO THEY LOWERED HER TO THE FLOOR. RESIDENT HAD AN X-RAY ON THE FOLLOWING DAY WHICH REVEALED A FRACTURE OF THE RIGHT DISTAL FEMUR.
IT WAS DISCOVERED THAT THE WAIST BELTS FOR THE LIFT WERE THREADED INCORRECTLY. THIS THREADING OF THE BELTS IS DONE BY THE CUSTOMER. NEW BELTS WERE ORDERED. EVENT WAS CAUSED BY IMPROPER USE AND MAINTENANCE OF WAIST BELTS. CUSTOMER HAS BEEN ADVISED TO REFER TO THE OPERATIONAL AND MAINTENANCE MANUAL FOR PROPER USAGE AND MAINTENANCE OF DEVICE. FREQUENCY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. FREQUENCY IS GREATER FOR THIS EVENT, THAN IS USUAL. SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. SEVERITY IS GREATER FOR THIS EVENT THAN IS USUAL. ADD'L INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT.
PT HAD A NORMAL VAGINAL DELIVERY. AFTER EPISIOTOMY REPAIR PHYSICIAN NOTICED LESS THAN 1MM TIP OF NEEDLE (PART OF SUTURE) MISSING. PT X-RAYED TO RULE OUT FOREIGN BODY. X-RAY NEGATIVE. PT SENT HOME WITHOUT COMPLICATIONS.
MONITOR-RESETTING ITSELF. CENTRAL STATIONS UNABLE TO PULL UP ALARM HISTORY-SYSTEM DISPLAYED TIME OUT MESSAGE "EVENT NOT AVAILABLE". INCORRECT TIME DISPLAYED ON MONITORS IN CCU AND ICU AS A RESULT OF ER MONITOR MALFUNCTION. VARIOUS PROBLEMS NOTICED WHEN DISCHARGING PTS FROM CENTRAL. CENTRAL STATIONS LOCKING UP WHILE RETRIEVING VITAL SIGNS AFTER NEW SOFTWARE WAS INSTALLED. VARIOUS ARRHYTHMIA CALLS MADE AT CENTRAL STATION THAT CONFLICT WITH WHAT NURSING STAFF SAW. ADD'L SERIAL NOS: J4SE1317G, H4SE1200G, J4SE1306G, H4SE1283G, H4SE1285G, J4SE1320G, J4SE1335G, J4SE1336G, H4SE1278G AND CENTRAL STATION MONITOR SERIAL NOS: K4KF0023G AND K4KF0028G.
RESIDENT GRABBED LATCH WHILE BEING TRANSFERED, THIS CAUSED THE HOOK TO CUT HER RING FINGER OF HER LEFT HAND.
UPON INSPECTION OF DEVICE WAS FOUND TO BE IN PROPER WORKING ORDER, BUT THE ROPE WHICH HOLDS THE HOOK WAS CUT OFF. RESIDENT WAS IMPROPER CANDIDATE FOR DEVICE, USER COULD NOT CONTROL RESIDENT. CUSTOMER HAS BEEN REFERED TO THE OPERATIONAL MANUAL FOR THE SELECTION OF PROPER CANDIDATES FOR THE DEVICE, AND PROPER USE OF THE DEVICE. FREQUENCY OF OCCURRENCE OF THE EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. FREQUENCY IS GREATER FOR THIS EVENT, THAN IS USUAL. SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. SEVERITY IS GREATER FOR THIS EVENT THAN IS USUAL. ADD'L INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT.
WHEN RETINAL SURGERY IS PERFORMED, SEVERAL TINY PORTS ARE MADE INTO THE EYE AND A LINE WITH FLUID IS CONNECTED TO ONE OF THESE PORTS TO REPLACE FLUID THAT WILL BE LOST DURING SURGERY. WHEN THE PHYSICIAN INSTRUCTED THE NURSE TO TURN ON THE FIELD, THE STOPCOCK APPEARED TO BE IN THE APPROPRIATE POSITION. THE PHYSICIAN CONFIRMED WITH THE NURSE THAT THE STOPCOCK WAS ON. WITH THE INITIAL ENTRANCE INTO THE VITREOUS, HYPOTONIA DEVELOPED DUE TO FAILURE IN THE INFUSION SYSTEM. THE BLOOD WAS REMOVED BY IRRIGATING THE ANTERIOR CHAMBER. THE PHYSICIAN VIEWED THE INSIDE OF THE EYE AND NOTICED A TEAR IN THE RETINA. IT CANNOT BE DETERMINED IF THE TEAR WAS A DIRECT RESULT OF LACK OF INITIAL INFUSION. A SCLERAL BUCKLE PROCEDURE WAS PERFORMED TO REPAIR THE RETINAL TEAR.
RESIDENT WAS RAISED ON LIFT, AND MOVED LATERALLY TO SIDE OF TUB, CNA MOVED THREE STEPS TO GET TOWELS. RESIDENT TURNED TO SIDE AND STRAP POPPED OFF, HIT RESIDENT IN HEAD CAUSING LACERATION TO FOREHEAD WHICH REQUIRED EIGHTEEN STITCHES.
INSPECTION REVEALED LOOSE BOLT ON CHASSIS/COLUMN MOUNT. LOOSE NUT ON WING ADJUSTER, OLD BELTS WERE COMING APART ON ENDS. BELTS HAVE BEEN REPLACED. INCIDENT CAUSED BY IMPROPER MAINTENANCE BY USER, AND OPERATOR ERROR. CUSTOMER HAS BEEN INSTRUCTED TO REFER TO THE OPERATIONAL AND MAINTENANCE MANUAL FOR PROPER MAINTENANCE AND USE OF DEVICE. FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED ION THE DEVICE LABELING. FREQUENCY IS GREATER FOR THIS EVENT, THAN IS USUAL. SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. SEVERITY IS GREATER FOR THIS EVENT THAN IS USUAL. ADD'L INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT.
THE PT WAS UNDERGOING AN ANTERIOR CERVICAL FUSION. THE SURGEON WAS USING THE CO ATTACHMENT. WHEN THE SURGEON RELEASED THE BURR FOOT PEDAL, THE PEDAL STUCK, THE BURR DID NOT TURN OFF AND A PARTIAL THICKNESS INJURY TO UPPER CERVICAL ESOPHAGUS OCCURRED. THERE WAS NO VISIBLE PENETRATION INTO THE ESOPHAGEAL LUMEN. THIS INJURY WAS SUTURED WITHOUT INCIDENT.
PT WAS IN OPERATING ROOM. THE ELECTRO SURGICAL UNIT WAS ON AND SHOWED.  RETURN ELECTRODE FAULT. RETURN ELECTRO PAD WAS LOOSE. REMOVED OLD PAD TO APPLY NEW ONE. NO MARK ON PT'S SKIN NOTED AT THIS TIME. AFTER SURGERY WAS DONE, PAD WAS REMOVED AND A 2" X 3" IRREGULAR DARK RED MARK WAS NOTED ON SKIN UNDER PAD AROUND LEFT THIGH.
THE DEVICE WAS PLACED ON 7/24/96 IN A CVA (CEREBRAL ACCIDENT VICTIM) PT WHO WAS ALSO ON A VENTILATOR. ON 7/27/96, THE PT WAS TAKEN TO SURGERY TO REMOVE THE FEEDING TUBE. THE INTERNAL BOLSTER HAD EMBEDDED INTO THE ABDOMINAL WALL. THE PT EXPERIENCED INTERNAL BLEEDING AND DEVELOPED PERITONITIS. ANOTHER TUBE WAS NOT PLACED AND THE PT IS STABLE. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT.
CO RECEIVED TWO MDR REPORTS FROM DISTRIBUTOR CONCERNING THE SAME SIZE AND TYPE OF DEVICE. THESE EVENTS OCCURRED AT THE SAME HOSP IN TWO VERY SIMILAR PTS. CO HAS NOT RECEIVED ANY PREVIOUS COMPLAINTS OF THIS NATURE ON THIS PARTICULAR PRODUCT. THE ACTUAL PERCENTAGE IS LESS THAN ONE HALF OF ONE PERCENT.
PT HAD AN ARTERIAL LINE IN THE ARM. DUE TO AN INCREASE IN PT ACTIVITY, I.E., PT FLEXING ARM, ETC., THE SHEATH OF THE ART LINE BROKE OFF INSIDE THE PT'S ARTERY. PT HAD SURGERY TO REMOVE THIS AND INCREASED LENGTH OF STAY IN THE HOSP BY ONE DAY. NO PT COMPLICATIONS. (DEN: 1009504)
RESPIRATORY THERAPIST NOTICED THE NURSE WAS HAVING DIFFICULTY MAINTAINING THE PT'S BLOOD PRESSURE. THE THERAPIST MENTIONED TO THE NURSE THAT THE PT WAS ON +5 PEEP, AND A DECISION WAS MADE TO DISCONTINUE IT. AS THE KNOB ON THE MACHINE WAS DECREASED FROM 5 TO 0, THE PRESSURE MANOMETER ROSE UP TO 20 OF PRESSURE. THE PT WAS TAKEN OFF THE VENTILATOR AND IMMEDIATELY VENTILATED MANUALLY WITH 100% OXYGEN. THE MANOMETER ON THE MACHINE FELL TO 0. THE THERAPIST CHECKED OVER THE MACHINE AND EVERYTHING APPEARED IN ORDER. THE MACHINE WAS THEN PLACED ON THE PT AGAIN, AND THE MANOMETER ROSE TO 20. THE MACHINE WAS REMOVED IMMEDIATELY, AND THE PT WAS PLACED ON ANOTHER. THE PT IS CURRENTLY UNSTABLE, AND BEING TREATED FOR AN AIR EMBOLIS.
A BURN WAS DISCOVERED ON THE PT'S RIGHT LOWER LEG BETWEEN THE KNEE AND THE ANKLE. THE BURN WAS THE SIZE OF THE BLADE ELECTRODE AND REQUIRED EXCISION AND SUTURING. THE BURN WAS DISCOVERED FOLLOWING A COSMETIC PROCEDURE WHICH LASTED FROM 8:00 AM TO 2:00 PM. THE PT'S STOCKING HAD A HOLE IN IT, ALTHOUGH NO CHARRING WAS EVIDENT, THE AREA WAS EXTREMELY WET. THE HOSP CONCLUDED THE PENCIL MAY HAVE BECOME INTERMITTENTLY ACTIVATED. (LABEL)
THE GENERATOR WAS NOT RETURNED TO CO FOR EVAL. THE GENERATOR MANUAL ADDRESSES THE USE OF A HOLSTER (COPY ATTACHED).
PT WAS IN OPERATING ROOM. THE ELECTROSURGICAL UNIT WAS ON AND SHOWED   RETURN ELECTRODE FAULT. RETURN ELECTRODE PAD LOOSE. REMOVED OLD PAD TO APPLY NEW ONE. NO MARK ON PTS SKIN NOTED AT THIS TIME. AFTER SURGERY WAS DONE, PAD REMOVED AND A 2" X 3" IRREGULAR DARK RED MARK WAS NOTED ON SKIN UNDER PAD. LEFT THIGH.
FEEDING TUBE WAS PLACED IN PT AND THE STYLET COULD NOT BE REMOVED. FEEDING TUBE WAS REMOVED AND A NEW ONE USED. THERE WERE NO PROBLEMS WITH THE SECOND ONE.
PRODUCT WAS FTESTED FBY SUING THE FEEING TUBE AND STYLET AS IT WOULD BE USED BY THE FACILITY. NO DIFFICULTY EXPERIENCED, UNABLE TO DUPLICATE PROBLEM.
BALLOON BURST-25CC PLACED IN 30CC PRODUCT. 3RD OCCURRENCE WITH PT, REPORTER MENTIONED IT MAY BE DUE TO STOMACH ACID.
FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N.  FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
HIVES FOLLOWING CONTRAST INFUSION. BENADRYL 50MG IM GIVEN. PRIOR H/ HIVES FOLLOWING CONTRAST THAT PT REMEMBERED AFTER REACTION.
FLUID DOESN'T FLOW PAST DRIP CHAMBER WHILE USING NITRO TUBING.
IMPLANT WAS PLACED ON 4/1/96. POOR HEALING POST-OP INFECTION.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS. NO, NO, YES, NO. RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND DIMENSIONALLY BY THE PT'S POOR HEALING.
STAPLER DID NOT FIRE PROPERLY WHEN USED ON PT.
DURING RIGHT TOTAL SHOULDER ARTHROPLASTY, THE 5.5 MM BURR USED TO DRILL SNAPPED/SHATTERED. TIP AND PIECES WERE RECOVERED.
PT CAME FOR PREGNANCY TERMINATION. LMP WAS 6I/18/96. PT WAS 7 WK GESTATION. SMALL SAC SEEN ON ULTRASOUND. SURGEON DID NOT OBTAIN ADEQUATE AMOUNT OF TISSUE. THE FOLLOW-UP B-HCG TESTS SHOWED AN INITIAL DROP FOLLOWED BY A RISE. PT'S REFERRAL FOR CONTINUED CARE WAS DELAYED BY INCORRECT LAB TESTS. MACHINE PREVIOUSLY MALFUNCTIONED IN 3/96 AND HAD BEEN RECHECKED BY CO.
IMPLANT WAS PLACED ON 5/1/96. POOR-HEALING-POST-OP INFECTION.
ANSWER TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE DIMENSIONALLY CORRECT. THE CAUSE OF FAILURE IS LIKELY THE REPORTED INFECTION, COMPOUNDED BY THE PT'S POOR HEALING.
WHILE IN SURGERY, INTERNAL PADDLES WERE TO BE USED AT 30 JOULES AND ATTEMPTED TO DISCHARGE TWICE AND DID NOT WORK. AFTER THESE TWO ATTEMPTS EXTERNAL PADDLES WERE USED AND FUNCTIONED PROPERLY. REVIEW OF THE INTERNAL PADDLES BY BIOMED TECHS REVEALED THE SCREWS AND INTERNAL PARTS OF THE CONNECTOR END TO BE CORRODED AND LOOKED LIKE THEY HAD BEEN WET. THIS IS NO SURPRISE AS THE CONNECTOR IS NOT SEALED IN ANY WAY AND IS SUBJECTED TO LOW TEMPERATURE STEAM ON EVERY CYCLE THROUGH THE ETO STERILIZER. THE CONNECTORS ARE NOT IMMERSED IN H2O OR CLEANING SOLUTION DURING THE DECONTAMINATION PROCESS. ALL INTERNAL PADDLEES AT FACILITY WERE REPLACED BY MFR.
IMPLANT WAS PLACED, LOCATION #14, WITH SINUS LIFT AND LEFT FOR 1 YR (PLACED 9/20/91). A TEMPORARY BRIDGE WAS PLACED FOR 6 MONTHS, AT WHICH TIME IMPLANT LOOKED GOOD. TEMPORARY BRIDGE BROKE AND IMPLANT WAS DISPLACED INTO SINUS. PT LATER STATED THAT HE HAD SINUS INFECTION FOR SEVERAL MONTHS PRIOR. IMPLANT WAS REPLACED AND IS SUCCESSFUL TODAY.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE DIMENSIONALLY CORRECT. THE BRIDGE BREAKING CAUSED THE IMPLANT TO BECOME DISLODGED. THIS COMPOUNDED BY THE REPORTED INFECTION, IS THE LIKELY CAUSE OF FAILURE.
PT DROVE HIMSELF TO HOSP. PHYSICIAN EXAMINED PT AND DIAGNOSED PACEMAKER MALFUNCTION. PACEMAKER TURNED OFF. PT SHOWED TACHYCARDIA ON MONITOR. DECISION MADE TO CARDIOVERT. STAFF BROUGHT DEFIBRILLATOR TO BEDSIDE, INSERTED PLUGS INTO MACHINE AND CHECKED UNIT. UNIT CHARGED WHEN STAFF ATTEMPTED TO DISCHARGE UNIT FOR CARDIOVERSION. UNIT FAILED TO DISCHARGE PROPERLY. SEVERAL ATTEMPTS WERE MADE TO NO AVAIL. A DIFFERENT UNIT WAS OBTAINED AND CARDIOVERSION WAS SUCCESSFUL. PT EXPERIENCED NO ADVERSE EFFECTS. CHECK OF UNIT REVEALED THAT THE QUICK COMBINATION MODULE LEVER WAS NOT COMPLETELY INTO THE LOCKED POSITION. THEIR IS NO NOTATION IN THE EQUIPMENT LABEL WHICH INDICATES THE SIGNIFICANT ROLE PLAYED IN OVERALL OPERATIONS BY THIS SWITCH.
PORTION OF RESECTOSCOPE LOOP BROKE INSIDE PT'S BLADDER. REMOVAL WAS A SUCCESS.
OPHTHALMOLOGIST IS USING A NON-APPROVED MACHINE.
TWO IMPLANT WERE PLACED ON 2/9/92 (SUSTAIN 4.7X8 #14 AND 4X10 #9). PT HAS A HABIT OF CHEWING ON TOOTHPICKS AND DEVELOPED AN ABCESSES AROUND BOTH IMPLANTS. PART OF A TOOTHPICK WAS FOUND AROUND #9. ONE IMPLANT WAS REMOVED ON 1/9/95.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE DISMENSIONALLY CORRECT. IT WAS COVERED WITH A WHITE/BROWN RESIDUE. INFECTION FROM THE EMBEDDED BIT OF TOOTHPICK COMPOUNDED BY THE PT'S SMOKING, IS LIKELY CAUSE OF FAILURE.
THIS METAL IMPLANT WAS PUT IN RT TMJ ON 1/12/94. SINCE RPTR HAS HAD SEVERE CHRONIC PAIN, NUMBNESS, INFECTION, AND IT POPS AND CRACKS AT TIMES, RPTR FINDS IT IS IIMPOSSIBLE TO CHEW OR OPEN HER MOUTH VERY FAR. RPTR WAS INFORMED THAT THE TISSUE AND BONE HAS DETERIORATED AND POSSIBLE THE DEVICE HAS BROKEN. RPTR HAS CHRONIC PAIN THAT RADIATES UP THROUGH THIS RT SIDE OF HER HEAD AND DOWN THROUGH HER NECK AND SHOULDERS. RPTR HAS TO GO TO THE HOSP EVERY COUPLE OF MONTHS TO HAVE IT MANUALLY MANIPULATED AND SHE IS ON STADOL, BECAUSE THE PAIN IS UNBEARABLE.
IMPLANT WAS PLACED ON 2/21/92. PT CALLED DESCRIBING CHRONIC SINUSITIS AND WAS UNDER CARE OF E.N.T. FOR APPROX 3 MONTHS. DURING THESE SYMPTOMS, NOT BEFORE, SHE BEGAN TO FEEL LOOSENESS IN HER IMPLANTS. EXAM REVEALED THAT THEY HAD ALL BEGAN INFECTED. ONE WAS REMOVED ON 7/3/96.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. MOST OF THE IMPLANT HAS BEEN RESORBED-A SIGN OF INFECTION. CAUSE OF FAILURE IS LIKELY INFECTION/GRANULOMA, COMPLICATED BY PT'S SMOKING.
BILATERAL RUPTURED IMPLANTS WAS REMOVED.
IN LT HIP PROSTHESIS REVISION, CUP AND LINER WAS REMOVED. CUP AND LINER ERODED, METAL EXPOSED. IMPLANTED AT ANOTHER HOSP. PT WAS DIAGNOSED WITH DISSOCIATED PLASTIC LINER IN LT ACETABULAR CUP ON 3/14/95. SURGERY WAS POST-PONED BY PT UNTIL 8/96.
SYSTEMS BOARD ON ELECTRONIC MONITOR FAILED, NO ALARMS SOUNDED. PT WAS FOUND UNRESPONSIVE IN RESPIRATORY ARREST. A DR STAT WAS CALLED, THE PT WAS RESUSCITATED AND TAKEN TO CARDIO-VASCULAR ICU WHERE HE LATER DIED. THE MFR'S REPAIR SERVICE TESTED THE EQUIPMENT AND REPLACED THE SYSTEM BOARD.
BATTERIES NOT IN PCA PAIN CONTROL PUMP. BATTERIES INSERTED, TUBE AND MEDICATION BAG PLACED IN PUMP AND CONNECTED TO THE PT. THE PUMP STARTED TO SMOKE FROM THE BACK SCREW PLATE WHICH BECAME HOT IMMEDIATELY. THE PUMP WAS IMMEDIATELY REMOVED FROM THE PT AND CARE AREA.
THERE WAS SMOKE AND THE SMELL OF SOMETHING BURNING COMING FROM THE BALLOON PUMP. THE OWNER, CO SALES TESTED AND REPAIRED THE PUMP. THE RECORDER POWER BOARD WAS BURNED. THE HOSP LEASES THE BALLOON PUMP.
PT ADMITTED FOR LAPAROSCOPIC BURCH PROCEDURE, ATP REPAIR WITH POSSIBLE RIGHT OVARIAN CYSTECTOMY. NEEDLE FROM DEVICE BROKE WHILE PASSING THROUGH COOPERS LIGAMENT REQUIRING AN OPEN LAPAROTOMY TO RETRIEVE THE NEEDLE PIECES (WHICH WAS DONE).
A 70 YR OLD FEMALE WITH CONFUSING HISTORY OF BREAST IMPLANTS. NO SPECIFIC TIMES ARE MENTIONED. SILICONE IMPLANTS IN PLACE FOR 6-7 YRS. PT COMPLAINED OF CAPSULE FORMATION OF THE LEFT. PT REQUIRED CAPSULATORY AND IMPLANT CHANGE. BILATERAL MASTOPEXY WAS FOUND INTACT WITH VERY THICK CAPSULES. TE LEFT HAD A FIBROTIC AREA "SALINE IMPLANT 18 YRS PRIOR WITH DEFLATION OF THE LEFT SIX YRS PRIOR. SILICONE PLACED SIX YRS AGO AND REPOSITIONED ONE WEEK POST OPERATIVELY. FIVE YEAR PRIOR BECAME INFECTED AND REPLACED MONTHS LATER." LEFT NOTED TO HAVE A COLLAPSED CAPSULE. PT HAD NOTED 5-8 MONTH HISTORY OF HARDNESS OF THE LEFT BREAST.
IMPLANT WAS PLACED ON 12/3/92. BRIDGE CAME OFF AND IMPLANT WITH IT, AFTER SEVERAL ATTEMPTS TO SAVE IT. THE MAXILLARY IMPLANTS HAVE NOT BEEN UNCOVERED.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE DIMENSIONALLY CORRECT. THE OUTER SURFACE WAS COVERED WITH A YELLOWISH RESIDUE. THE LIKELY CAUSE OF FAILURE IS THE REPORTED INFECTION/GRANULOMA.
A 70 YR OLD FEMALE WITH CONFUSING AND UNCLEAR HISTORY OF BILATERAL AUGMENTATION. SILICONE IMPLANT OF 6-7 YRS WAS REMOVED FROM RIGHT. PT REQUIRED CAPSULOTOMY AND IMPLANT EXCHANGE. SHE ALSO REQUIRED BILATERAL MASTOPEXY. "SALINE IMPLANT 18 YRS PRIOR WITH DEFLATION OF LEFT SIX YRS PRIOR. SILICONE PLACED 6 YRS PRIOR AND REPOSITIONED POST OPERATIVELY 5 YRS PRIOR BECAME INFECTED AND REPLACED MONTHS LATER".
IMPLANT WAS PLACED ON 12/3/92. BRIDGE CAME OFF AND IMPLANT WITH IT, AFTER SEVERAL ATTEMPTS TO SAVE IT. THE MAXILLARY IMPLANTS, #13 AND #14, HAVE NOT BEEN UNCOVERED.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. MOST OF THE IMPLANT HAD BEEN RESORBED, A SIGN OF INFECTION. THE REPORTED INFECTION IS THE LIKELY CAUSE OF FAILURE.
IMPLANT WAS PLACED ON 10/16/92. PT HAD JUST RECOVERED FROM SEVERE MEDICAL PROBLEMS, WHICH PREVENTED HER FROM RECEIVING ANY MAINTENANCE OF HER IMPLANTS FOR APPROX 9 MONTHS.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANTS WERE EVALUATED AND MEET SPECS. THE CAUSE OF FAILURE IS LIKELY THE  REPORTED INFECTION, WHICH PERHAPS IS A RESULT OF PT'S INABILITY TO RECEIVE IMPLANT MAINTENANCE FOR 9 MONTHS.
IMPLANT WAS PLACED ON 3/13/92. PT: HEAVY BRUXISM. PT REPORTED PAIN ON CHEWING FOR SEVERAL MONTHS TO GENERAL DENTIST.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. MOST OF THE IMPLANT HAD BEEN RESORBED. THE LIKELY CAUSED OF FAILURE IS THE PT'S BRUXISM AND SMOKING, COMPLICATED BY INFECTION.
PERITONITIS. 5L BAGS OF DIALYSATE SUSPECT. PT RE-TRAINED TO NEW SYSTEM. TREATED WITH ANTIBIOTICS.
DURING A REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, TWO SUTURELESS LEADS WERE REMOVED FROM SERVICE BECAUSE OF AN INSULATION BREAK. THE LEADS WERE CAPPED AND REMAIN IMPLANTED.
THE TWO MYOCARDIAL LEADS REMAIN IMPLANTED CAUSE OF THE INSULATION BREAK COULD NOT BE DETERMINED OR EVALUATED. CO DID NOT RECEIVE AN USER FACILITY REPORT ON THIS REPORT.
PERITONITIS. 5L BAGS OF DIALYSATE SUSPECT. PT RE-TRAINED TO NEW SYSTEM. TREATED WITH ANTIBIOTICS SETS ALSO SUSPECT.
A MARKETING SURVEY WAS RECEIVED FROM A PT WHO REPORTED THAT HE/SHE RECEIVED HIS/HER FIRST TREATMENT IN THE GLABELLA NASOLABIAL FOLDS, AND HORIZONTAL FOREHEAD LINES (EXACT DATE UNKNOWN). THE PT NOTED: "I WAS MOST PLEASED WITH THE GLABELLA RESULT AND NOT PLEASED WITH THE FOREHEAD RESULTS. TO ME, THE FOREHEAD LINES LOOKED MORE PROMINENT, (I.E. RIDGED AND SCAR-LIKE)." THE PT DID NOT PROVIDE A NAME OR ADDRESS; CONSEQUENTLY, FOLLOW UP WAS NOT POSSIBLE.
PAT. PROB. CODE: 1436-LABELED. PAT PROB CODE: 2060-LABELED.
PERITONITIS. 5L BAGS OF DIALYSATE SUSPECT. PT RE-TRAINED TO NEW SYSTEM. TREATED WITH ANTIBIOTICS. SETS ALSO SUSPECT.
BILATERAL CAPSULECTOMY WITH REMOVAL OF INTACT IMPLANTS WAS REPORTED.
CENTER RECENTLY CHANGED THE MFR OF THE FORMER ANESTHESIA MACHINE. SOMEHOW THE OXYGEN SENSOR WAS REMOVED FROM THE NEW MACHINE WHICH RESULTED IN IT APPEARING LIKE THE OLD MACHINE. AS A RESULT, WHEN THE ANESTHESIOLOGIST CHEMICALLY PARALYZED THE PT, THE PT WAS RECEIVING ROOM AIR WITH NO POSITIVE PRESSURE VENTILATION. THE PT BECAME HYPOXIC WHICH WAS IMMEDIATELY RECOGNIZED BY THE ANESTHESIOLOGIST WHO CORRECTED THE PROBLEM. THE PT RESPONDED WITHOUT ADVERSE EFFECT OR SERIOUS INJURY.
COLONSCOPY WITH BX ON 8/5/96 AM, PT DISCHARGED 11:00. PT RETURNED TO EMERGENCY AT 01:00 ON 8/6/96 WITH "ACUTE ABD." FREE AIR STUDY NEGATIVE. PT IN HOSP UNTIL PAIN SUBSIDED.
PT WAS ON RADIOLOGY TABLE AND MOVED HER HAND OFF TABLE WHILE CARRIAGE WAS BEING MOVED BY TECHNICIAN. LEFT MIDDLE FINGER WAS CAUGHT BETWEEN FLOOR CARRIAGE AND STATIONARY ELECTRICAL BOX CAUSING A LACERATION TO FINGER AND FRACTURE TO LEFT MIDDLE FINGER. LACERATION REQUIRED SUTURES, FINGER WAS SPLINTED.
PT WAS ANESTHESTIZED WITHOUT DIFFICULTY, AND PREPPED AND DRAPED FOR LAPARSCOPIC CHOLECYSTECTOMY. ABDOMEN INSUFFLATED WITH CO2 TO NORMAL DISTENSION. UMBILICAL  PORT INSERTED AND ABDOMEN EXAMINED WITH NORMAL FINDINGS. UPPER MIDLINE PORT INSERTED IN USUAL LOCATION, AND BRISK BLEEDING NOTED JUST ABOVE PYLORIC VEIN. THIS WAS TAMPONADED WITH PRESSURE USING SURGICAL GAUZE. NO FURTHER BLEEDING NOTED. WITHIN ONE OR TWO MINUTES, BLOOD PRESSURE DROPPED TO 40MM HG. WHOLE BLOOD IMMEDIATELY STARTED WITH PRESSURE. CENTRAL VENOUS LINE PLACED IN LEFT FEMORAL VEIN, PRESSURE CONTINUED TO DROP. CARDIAC ARREST OCCURRED. THE HEART FAILED TO START AND ABDOMEN WAS ENTERED VIA UPPER MIDLINE INCISION (PORTS HAD BEEN REMOVED FOR SHOCKING). WHEN SURGEON ENTERED ABDOMEN, CONSIDERABLE BLOOD CLOTS WERE NOTED IN RIGHT AND LEFT GUTTERS. AORTA WAS MOBILIZED AND STELLATE 0.5 CM PUNCTURE WOUND WAS FOUND AT LEVEL OF UPPER PYLORUS. PT PRONOUNCED, PROCEDURE TERMINATED, AND FAMILY NOTIFIED BY PHYSICIANS.
DEFIBRILLATOR WAS USED DURING A CARDIAC ARREST AND DID NOT DISCHARGE UPON DEPRESSING THE CHARGE RELEASE BUTTONS IN THE PADDLES. THE MACHINE WAS DISCONNECTED IMMEDIATELY AND ANOTHER ONE REPLACED IT. IT IS UNKNOWN WHAT CAUSED THE MALFUNCTION TO OCCUR. THE PT WAS SUCCESSFULLY DEFIBRILLATED AND TRANSFERRED TO THE CORONARY CRITICAL CARE UNIT AND EXPIRED FOUR DAYS LATER.
DURING STEREOTAXIC BIOPSY PROCEDURE, DRILL BIT WAS BEING USED VIA HAND DRILL. DRILL BIT BROKE APPROX. 1" FROM TIP. INCISION HAD TO BE EXTENDED TO FIND TIP WHICH WAS LODGED IN SCALP.
IMMEDIATELY UPON STARTING HEMODIALYSIS TREATMENT, THE BLOOD LEAK ALARM WENT OFF. THERE WAS A GROSS BLOOD LEAK COMING FROM A FIRST USE DIALYZER. EBL>100CC. DIALYSIS WAS STOPPED AND THEN STARTED USING A DIFFERENT DIALYZER WITHOUT FURTHER INCIDENT. THE SAMPLE WAS DISCARDED BY THE FACILITY.
IMMEDIATELY UPON STARTING HEMODIALYSIS TREATMENT THE BLOOD LEAK ALARM SOUNDED. THERE WAS A GROSS BLOOD LEAK ON A FIRST USE DIALYZER. EBL> 100CC. DIALYSIS WAS STOPPED AND THEN STARTED WITH A NEW DIALYZER WITHOUT FURTHER INCIDENT. THE DIALYZER WAS DISCARDED BY THE FACILITY.
A PT WAS TREATED ON 4/4/96 IN THE GLABELLA, RIGHT PERIORBITAL LINES, VERMILLION BORDERS, AND A SCAR AT THE CHIN. ON 4/26/96, THE PT PRESENTED WITH SWELLING AND INDURATION AT THE TREATMENT SITES (DATE OF ONSET UNKNOWN); THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY. SHE ALSO PRESENTED WITH HERPES SIMPLEX AT THE LOWER LEFT VERMILLION BORDER TREATMENT SITE; ORAL VALTREX AND ZOVIRAX WERE PRESCRIBED. THE PHYSICIAN BELIEVED THAT THE HERPES SIMPLEX WAS POSSIBLY RELATED TO THE COLLAGEN HYPERSENSITIVITY. ON 5/10/96, THE PT PRESENTED WITH ERYTHEMA, SWELLING, AND INDURATION AT THE TREATMENT SITES WHICH INTERMITTENTLY FLARED; INTRAMUSCULAR TRIAMCINOLONE WAS PRESCRIBED. ON 8/2/96, THE PT PRESENTED WITH PERSISTENT SYMPTOMS AT THE TREATMENT SITES, SWELLING UNDERNEATH THE EYES, AND HERPES SIMPLEX AT THE LOWER LEFT VERMILLION BORDER TREATMENT SITE; ORAL VALTREX WAS PRESCRIBED. 8/2/96, THE PT ALLEGED THAT THE "LUMPS" AT THE GLABELLAR TREATMENT SITE "HAD A LIFE OF THEIR OWN", AND "MELTED DOWN" FROM THE GLABELLAR TREATMENT SITE TOWARD THE NOSE AND UNDER THE EYES. THE PHYSICIAN BELIEVED THE "MELT DOWN" DESCRIBED BY THE PT WAS EDEMA FROM THE GLABELLAR TREATMENT SITE. THE PT ALLEGED THAT THE SWELLING IMPAIRED HER VISION; THE PHYSICIAN DID NOT BELIEVE THE PT'S VISION WAS IMPAIRED. THE PT ALSO STATED THAT SHE WAS DEPRESSED AND UNABLE TO LEAVE HER HOUSE BECAUSE OF THE SYMPTOMS. THE PHYSICIAN BELIEVED THAT THE DEPRESSION WAS RELATED TO THE PT'S DISTRESS ABOUT THE HYPERSENSITIVITY SYMPTOMS.
PAT. PROB. CODE: 1907-LABELED. PAT. PROB. CODE: 1898-LABELED. PAT. PROB. CODE: 2091-NOT LABELED. PAT. PROB. CODE: 2361-NOT LABELED. PAT. PROB. CODE: 2140-LABELED.
A PT RECEIVED HER FIRST TREATMENT ON 7/18/96 IN THE GLABELLA, UPPER AND LOWER VERMILLION, AND VERMILLION BORDERS. IMMEDIATELY AFTER TREATMENT TO THE GLABELLA, A "SLIGHT BLANCH" WAS OBSERVED, WHICH THE PHYSICIAN ATTRIBUTED TO "USUAL" BLANCHING FOLLOWING TREATMENT. ON 7/22/96, THE PT PRESENTED WITH A 1.0 CM X 0.5 CM AREA OF ERYTHEMA AND SKIN BREAKDOWN AT THE GLABELLAR TREATMENT SITE. THE PHYSICIAN WAS UNSURE IF THE SYMPTOMS REPRESENTED A VASCULAR OCCLUSION OR AN INFECTION; ORAL CEFTIN AND LOCAL WOUND CARE WERE PRESCRIBED. ON 7/29/96, THE PT PRESENTED WITH PERSISTENT ERYTHEMA AND PARTIAL THICKNESS SKIN SLOUGH AT THE GLABELLAR TREATMENT SITE. THE PHYSICIAN BELIEVED THAT THE SYMPTOMS PROBABLY REPRESENTED A NECROSIS; LOCAL WOUND CARE WAS PRESCRIBED.
A LETTER REQUESTING FOLLOW UP INFORMATION WAS RETURNED FROM PATIENT HAD SOME SCARRING AT THE GLABELLAR TREATMENT SITE. 1971 NECROSIS INJECTION SITE.
A PT WAS DOUBLE SKIN TESTED ON 12/2/92 AND 6/20/96, AND RECEIVED HER FIRST TREATMENT ON 7/17/96 IN THE NASOLABIAL FOLDS. ON 8/2/96, THE PT NOTED REDNESS, SWELLING, AND FIRMNESS AT THE NASOLABIAL TREATMENT SITES; ORAL PREDNISONE WAS PRESCRIBED. ON 8/5/96, SHE PRESENTED WITH PERSISTENT ERYTHEMA, SWELLING, AND INDURATION AT THE TREATMENT AND RETEST SITES. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY; ORAL PREDNISONE WAS PRESCRIBED.
PT WAS TREATED ON 7/15/96 TO THE GLABELLA AND CORNERS OF THE MOUTH. LATER THAT EVENING, THE PT DEVELOPED PAIN AND A BRUISED APPEARANCE AT THE GLABELLA AND AREAS OF ERYTHEMA DESCRIBED AS "NEEDLE MARKS" AT THE CORNERS OF THE MOUTH. THE PT'S EMPLOYER WHO IS A PHYSICIAN PRESCRIBED VICODIN FOR THE PAIN ON 7/16/96; THE PAIN RESOLVED WITHIN 1-2 DAYS. THE PT SUBSEQUENTLY DEVELOPED A BLACK CENTER SURROUNDED BY ERYTHEMA AT THE GLABELLA. "WHITE PUSTULES" AND A CRUST DEVELOPED AT THE GLABELLA ON APPROX 7/18/96. ON APPROX 7/20/96, THE PT RETURNED TO THE INJECTING PHYSICIAN WHO DIAGNOSED A LOCAL NECROSIS AND PRESCRIBED POLYSPORIN OINTMENT. ON 8/7/96, THE PT DESCRIBED A DEPRESSION AND ERYTHEMA AT THE GLABELLA AND A PINK DOT AT ONE CORNER OF HER MOUTH. ON 8/7/96, THE PT WAS SEEN BY A CONSULTING PHYSICIAN, WHO ALSO DIAGNOSED A LOCAL NECROSIS; CONTACT WITH THIS PHYSICIAN WAS REFUSED.
THERE WAS NO RESPONSE TO A FOLLOW UP REQUEST SENT TO THE PHYSICIAN. THE INJURY CATEGORY WILL BE UPDATED TO PERMANENT DAMAGE.
THE SURGEON WAS UNABLE TO SEAT THE INSERT TO HIS SATISFACTION-TOO LOOSE. USE ANOTHER INSERT INSTEAD.
A PT WAS TREATED ON 7/30/96 INTO THE MENTAL FOLD OF THE CHIN, CORNERS OF THE MOUTH AND GLABELLA. THE PHYSICIAN NOTED A WHITISH DISCOLORATION AT THE CHIN CREASE IMMEDIATELY AFTER THE TREATMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS PRESCRIBED. BETWEEN 8/3/96 AND 8/4/96, THE CHIN TREATMENT SITE BEGAN TO BLEED AND OOZE PUS AND BECAME PAINFUL AND THROBBING. ON 8/6/96, THE PHYSICIAN OBSERVED A RAW OPEN WOUND AT THE CHIN. HE DIAGNOSED A NECROSIS AND PRESCRIBED TOPICAL NITROGLYCERIN FOR THE INTACT AREAS AROUND THE TREATMENT SITE, POLYSPORIN WITH A TELFA PAD FOR THE OPEN WOUND, AND PERCOCET FOR PAIN. THE GLABELLA AND CORNERS OF THE MOUTH REMAINED ASYMPTOMATIC.
ON 9/6/96, THE PATIENT PRESENTED WITH A 15 X 10 MM AREA OF REDNESS AND A HYPERTROPHIC SCAR AT THE MEDIAL PORTION OF THE CHIN TREATMENT SITE. THE PHYSICIAN PLANNED TO PRESCRIBE SILICON SHEETING, DERMABRASION, OR FAT INJECTIONS IN THE FUTURE. A FOLLOW UP CALL ON 3/3/97 REVEALED THAT THE PATIENT HAD NOT BEEN SEEN SINCE THAT TIME. IT IS UNK WHETHER ANY OF THE PLANNED INTERVENTION WAS PERFORMED. 1971 NECROSIS INJECTION SITE.
CNA WAS POSITIONING SHOWER CHAIR IN SHOWER ROOM. THE RIGHT REST LEG FITTING OF THE CHAIR DEVELOPED A CRACK AND THE CASTER FELL OFF. THE CHAIR TIPPED BACK WITH PT IN THE CHAIR. THE CNA SUPPORTED THE HEAD TO BREAK THE FALL. NO REPORTED INJURY TO THE PT.
A PHYSICIAN REPORTED A PT WAS TREATED ON 7/9/96 IN THE VERMILLION BORDERS, ORAL COMMUSSURES, AND NASOLABIAL FOLDS. IMMEDIATELY AFTER THE TREATMENT, THE PT NOTED "LITTLE BUMPS" AT THE VERMILLION BORDER TREATMENT SITES. ON 7/22/96, SHE PRESENTED WITH "BEAD-LIKE PAPULES" AT THE VERMILLION BORDER TREATMENT SITES WHICH THE PHYSICIAN BELIEVED WAS COLLAGEN PLACED TOO SUPERFICIALLY BETWEEN THE EPIDERMIS AND DERMIS. THE PHYSICIAN MADE A STAB INCISION AND TRIED TO EXPRESS SOME OF THE COLLAGEN IMPLANT. SHE INSTRUCTED THE PT TO FREQUENTLY MASSAGE THE AREA.
ICD LEAD FAILURE PER REFERRING DR WITH INAPPROPRIATE SHOCKS. LEAD EXPLANTED AND REPLACED WITH NEW NON-THORACOTOMY LEAD VIA LEFT SUBCLAVIAN VEIN. LEAD IMPLANTED AT ANOTHER FACILITY ON 4/1/94.
EMPLOYEE/PHYSICIAN HAD FIBEROPTIC CABLE FOR HEAD LIGHT BREAK APPROX. ONE FOOT FROM THE LIGHT SOURCE. IT BECAME HOT AT SURGEON'S NECK AND CAUSED BURNING SENSATION AND PAIN.
PT HAD AORTIC VALVE IMPLANTED ON 4/24/96. PT DEVELOPED BACTERIAL ENDOCARDITIS AND THROMBOEMBOLUS TO RIGHT LEG. PT UNDERWENT EMBOLECTOMY. IT WAS SUSPECTED THE ARTIFICIAL VALVE WAS INFECTED. PT RETURNED TO SURGERY ON 8/1/96 FOR ALLOGRAFT REPLACEMENT OF MECHANICAL VALVE. AFTER REPLACEMENT OF MECHANICAL VALVE, PT WAS UNABLE TO COME OFF OF BYPASS.
ESRD OUTPATIENT USING HOME PD EQUIPMENT AND SUPPLIES EXHIBITED CLINICAL SYMPTOMS OF PERITONITIS. FOURTEEN OTHER ESRD HOME PTS ALSO USING THE SAME TYPE OF SUPPLIES AND EQUIPMENT DEVELOPED PERITONITIS WITHIN A FEW DAYS OF EACH OTHER. TWELVE OF THE FOURTEEN PTS WERE HOSPITALIZED FOR TREATMENT.
PT WAS SKIN TESTED IN THE EARLY 1980'S (EXACT DATE AND NAME OF INJECTING PHYSICIAN NOT RECALLED). SHE IMMEDIATELY NOTED A LUMP AT THE SKIN TEST SITE WHICH RESOLVED SPONTANEOUSLY IN A FEW DAYS (DATE OF RESOLUTION NOT RECALLED). THE INJECTING PHYSICIAN DIAGNOSED A NEGATIVE SKIN TEST. THE PT WAS NOT TREATED WITH COLLAGEN. IN 1988, THE PT HAD SILICONE BREAST IMPLANTS PLACED BY THE PHYSICIAN WHOSE NAME SHE COULD NOT RECALL. SHORTLY AFTER THE IMPLANTS WERE PLACED, SHE DEVELOPED NECK PAIN. THE NECK PAIN WAS ATTRIBUTED TO THE WEIGHT OF THE BREAST IMPLANTS WHICH CAUSED PULLING OF HER CHEST MUSCLE WHICH THEN PULLED ON HER ALREADY WEAKENED CERVICAL MUSCLES. SHE THEN DEVELOPED FATIGUE, JOINT AND MUSCLE STIFNESS AND PAIN. THE PT ALLEGED THESE SYMPTOMS WERE DIAGNOSED AS NON-SPECIFIC AUTOIMMUNE DISEASE BY THE PLASTIC SURGEON; INFO TO CONFIRM THE DIAGNOSIS WAS NOT IN THE CHART. THE PT ALLEGED THE PLASTIC SURGEON ATTRIBUTED THE NON-SPECIFIC AUTOIMMUNE DISEASE TO THE BREAST IMPLANTS. IN 1991, SHE GAVE BIRTH TO A SON. IN 1992, SHE BECAME FATIGUED; THYROID BLOOD TESTS WERE WITHIN NORMAL LIMITS. A PHYSICIAN SPECIALIZING IN THYROID CONDITIONS DIAGNOSED THE PT WITH HASHIMOTO'S DISEASE VIA ULTRASOUND TESTING. A NATURAL THYROID SUPPLEMENT WAS PRESCRIBED. HER SILICONE BREAST IMPLANTS WERE EXPLANTED IN 1993; HER SYMPTOMS WERE ABOUT THE SAME AFTER THE EXPLANT. SHE DID NOT DISCUSS HER COLLAGEN SKIN TEST WITH ANY OF HER PHYSICIANS; SHE DID NOT BELIEVE THE SYSTEMIC SYMPTOMS WERE RELATED TO THE COLLAGEN SKIN TEST.
ON 12/1/96, A CONSULTING PHYSICIAN WHO DIAGNOSED HASHIMOTO'S WAS UNABLE TO PROVIDE INFO WITHOUT AUTHORIZATION FROM THE PATIENT. ON 1/7/97, A REVIEW OF THE PATIENT'S CHART AT THE PLASTIC SURGEON'S OFFICE DID NOT REVEAL A NOTATION REGARDING DIAGNOSES OF NON-SPECIFIC AUTOIMMUNE DISEASE OR HASHIMOTO'S THYROIDITIS. THE PHYSICIAN WHO TOOK OVER THE PLASTIC SURGEON'S PRACTICE BELIEVED THAT THE ALLEGED SYMPTOMS WERE PROBABLY NOT RELATED TO COLLAGEN.
PT SAT ON PRODUCT BUCKET NOT PROPERLY ATTACHED TO FRAME OF SEAT OF PRODUCT WHICH PINCHED THE PT'S SKIN (POSTERIOR THIGH). THE AREA AFFECTED WAS LESS THAN DIME SIZE. IT WAS CLEANSED AND KEPT DRY, LEFT OPEN TO HEAL. 1/2CM    NONDRAINING WOUND.
A PRESSURE IRRIGATOR DOOR CRACKED UNDER A REPORTED AIR PRESSURE OF ABOUT 550MM HG. A PIECE OF THE DOOR FULLY SEPARATED FROM THE COVER ALONG THE FULL LENGTH OF THE LATCH SIDE OF THE DOOR. THE PART THAT SEPARATED WAS UNDER THE LATCH.
THE CUSTOMER WAS CONTACTED TO OBTAIN THE UNIT'S HISTORY. THE COMPLAINANT STATED THAT TO HIS KNOWLEDGE NO CHEMICALS OTHER THAN 10% CHLORINE BLEACH & WATER HAVE BEEN USED FOR CLEANING. THE FAILURE INVESTIGATION ALSO FOUND THAT THE PRESSURE GAUGE WAS OUT OF CALIBRATION. A PRESSURE READING OF ABOUT 500MM HG WAS MORE LIKELY TO BE AN ACTUAL PRESSURE OF ABOUT 610-635MM HG, THUS THE UNIT WAS SUBJECTED TO EXTREME PRESSURES BEYOND THOSE OF NORMAL OPERATION. CONTINUING LAB EVALS HAVE FOUND THAT OVERPRESSURE CONDITIONS OF THIS RANGE ARE NOT LIKELY TO RESULT IN PREMATURE DOOR FAILURE IF A UNIT IS NOT SUBJECTED TO CHEMICAL CLEANING OR HEAT TREATING DURING PROCESSING. THIS UNIT MAY HAVE BEEN SUBJECTED TO HEAT DURING PROCESSING. THIS PROCESS STEP WAS REMOVED FROM THE MANUFACTURING SEQUENCE ON 07-11-96.
VENTILATOR DEPENDENT CHILD WAS SITTING ON A TRAMPOLINE AT HOME, ROCKING BACK AND FORTH. THE VENTILATOR CIRCUIT WAS PULLING ON THE TRACHEOSTOMY TUBE CONNECTION. THE DISTAL PORTION OF THE TUBE SHAFT BROKE AT THE NECKFLANGE.
PRODUCT DESIGNED BY AND CUSTOM MANUFACTURED FOR THIS HOSPITAL. CO RECEIVED 1 PIECE OF A TUBE. THE PRODUCT HAS BEEN USED. UPON EXAMINATION CO OBSERVED THE FOLLOWING: 1. THE TRACH SWIVAL CONNECTOR WAS MISSING FROM THE UNIT. 2. THE PROXIMAL END OF THE SHAFT (ONE PIECE SHAFT) HAS BEEN SEPARATED FROM THE DISTAL END (SEE ATTACHED PHOTOGRAPH). THE BREAK OCCURRED AT THE BOND SITE PROXIMAL TO THE NECKSTRAP, THE BOND ITSELF DID NOT FAIL. THE SEPARATION BROKE BOTH THE INNER SHAFT AND OUTER SLEEVE. TEH REINFORCING WIRE DID NOT BREAK OR BECOME UNRAVELED. CO CONDUCTED A DESTRUCTIVE TEST ON THE SHAFT TO DETERMINE IF THE SHAFT/SLEEVE MAY HAVE BEEN DEFECTIVE. USING THE INSTRON CO DID A TEST TO DETERMINE THE FORCE REQUIRED TO PULL APART THE SHAFT. THE RESULT WAS A FORCE OF 33.4LBS. THE RESULT WAS WELL WITHIN THE DESIGN PARAMETERS FOR THIS PRODUCT. IT WAS NOTED ON THE MED-WATCH THAT THE PT WAS SITTING ON A TRAMPOLINE AND ROCKING BACK AND FORTH, PULLING ON THE TRACH. WE CAN ONLY ASSUME THAT THE EXCESSIVE MOVEMENT BY THE CHILD MOST LIKELY APPLIED A FORCE TO THE TRACH GREATER THAN WHAT THIS PRODUCT CAN SAFELY WITHSTAND.
510K #935276. 1 PERSON.  FREQUENCY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
510K #950928. 1 PERSON. FREQUENCY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING.  IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
MEDICATION ORDERED FOR PT AT RATE OF .05 MG OVER A FOUR HOUR PERIOD OF TIME. MEDICATION DELIVERED AT .05 MG IN 50 MINUTES. POSSIBLE SIDE EFFECTS IS KIDNEY SHUT DOWN WHEN DELIEVRED AT THIS RATE.
WHILE EXCHANGING A 2.0MM BURR FOR A 2.5MM BURR, THE GUIDE WIRE WAS INADVERTENLY PULLED BACK AND THEN REPOSITIONED. WHEN ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE, RESISTANCE WAS ENCOUNTERED. THE GUIDE WIRE SPRING TIP UNRAVELED AND FRACTURED. THE DISTAL PORTION REMAINED IN THE PT WITH NO REPORTED INJURY.
THE BALLOON BURST IN SITU AFTER THREE DAYS OF USE. THE CATHETER WAS REMOVED WITHOUT ANY COMPLICATIONS.
DURING ROUTINE TESTING OF THE DEFIBRILLATOR, THE USER DISCOVERED THAT IT WOULD NOT CHARGE. THERE WAS NO PT INVOLVED.
ANALYSIS DETERMINED THAT A ZENER DIODE (CR21) ON ASSEMBLY NUMBER 590263 HAD SHORTED. THAT CAUSED THE 12 VOLT POWER SUPPLY ON THE ASSEMBLY TO BE INOPERATIVE. THIS WAS A RANDOM COMPONENT FAILURE, AND NO ADDITIONAL ACTION IS ANTICIPATED.
A FEMORAL CANNULA CONTAINED IN FEM-020 PERCUTANEOUS ACCESS KIT, WAS DISCOVERED PRIOR TO USE, HAVING A CRACKED 3/8" STRAIGHT CONNECTOR. THE UNIT IS BEING RETURNED AND EVENT WILL BE FURTHER EVALUATED AT THAT TIME.
SEVERITY OF OCCURRENCE STATEMENT (21 CFR 803.24 (C) (7). TO CO'S KNOWLEDGE, THIS TYPE OF EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THIS TYPE OF EVENT.
PT UNDERWENT SURGICAL PROCEDURE REQUIRING DRAINAGE DEVICE. UPON ORDERED REMOVAL OF DRAINAGE DEVICE, DRAIN BROKE. PART OF DRAINAGE DEVICE WAS RETAINED IN PTS ABDOMEN, REQUIRING SURGICAL INTERVENTION FOR REMOVAL. AT TIME OF REMOVAL, IT WAS NOT DISCOVERED THE PART OF THE DRAIN WAS RETAINED.
PT WITH SEVERE FIBROCYSTIC BREAST DISEASE. ORIGINAL BILATERAL SUB-CUTANEOUS MASTECTOMIES WITH RECONSTRUCTION IN 6/80. CAPSULAR CONTRACTURES DEVELOPED WITH FURTHER SURGERY REQUIRED. 12/1/82 MAMMARY IMPLANTS REMOVED, FIBROUS CONTRACTURES RELEASED AND MUSCLE FLAPS RECONSTRUCTED WITH INSERT OF MAMMARY IMPLANTS. PT DEVELOPED PAIN AND TENDERNESS OF BREAST AREA WHICH WAS CONSTANT. OR PERFORMED. BILATERAL RUPTURE OF SHELL OF IMPLANT IDENTIFIED DURING OR.
FOLLOWING CANNULATION A CRACK IN THE 3/8" STRAIGHT CONNECTOR WAS NOTICED. THE CANNULATOR WAS REPLACED WITH NO ADVERSE EFFECT TO THE PT.
TO CO'S KNOWLEDGE, THIS TYPE OF EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THIS TYPE OF EVENT.  FREQUENCY OF OCCURRENCE FOR THIS TYPE OF REPORTED EVENT IS: 1 REPORTED EVENT OUT OF 77,218 PVC STRAIGHT CONNECTORS. (.0013%).
IMPLANT WAS REMOVED BY PT'S REQUEST DUE TO PAIN.
1990 PT HAD BILATERAL BREAST AUGMENTATION WITH 310 CC SILICONE IMPLANTS. 12/95 PT COMPLAINED OF CAPSULAR CONTRACTURE WTIH RESULTING PAIN AND DEFORMITY IN APPEARANCE. PT WISHED TO HAVE IMPLANTS REMOVED BECAUSE OF DISCOMFORT AND DEFORMITY. BREAST EXAM REVEALED BAKER'S CLASS. GRADE IV CAPSULAR CONTRACTURE ON RIGHT WITH PAIN AND DEFORMITY. NO OBVIOUS MASSES OR NIPPLE DISCHARGE. IMPLANTS REMOVED INTACT WITH EVIDENCE OF RUPTURE OR SILICONE BLEED.
ADDITIONAL INFO RECEIVED FROM MFR ON 09/06/1996: AN EVALUATION WAS PERFORMED BY THE COMPANY'S REPRESENTATIVE ON THE CHAIR IN QUESTION. NO MALFUNCTION OR SAFETY HAZARD POTENTIAL WAS FOUND. BOTH CO REP. AND DEALERSHIP TECHNICIAN CONCLUDED THE CAUSE TO BE POSITIONING OF END USER IN THE CHAIR. COMPANY'S REP. STATED THIS FACT TO THE END USER AND HER ATTENDANT.
PT WAS ON MORPHINE SULFATE IV PUMP; HAD PERIOD OF RESPIRATORY DISTRESS, DECREASE IN REPSPIRATION, REQUIRED INTUBATION. PT STATED WHEN RECOVERED THAT SOMETHING MALFUNCTIONED WITH PUMP.
PORT INSERTION WAS ON 5/1/96. DEVICE WAS BELIEVED TO BE MALFUNCTIONING SO PT UNDERWENT SURGERY TO REMOVE DEVICE. DURING THE OPERATION, THE PORT WAS FOUND TO BE SEVERED FROM THE CATHETER. THE CATHETER HAD MIGRATED OUT OF SAFE RECOVERY BY THE SURGEON. THE PT WAS LATER TAKEN TO THE CARDIAC CATHETERIZATION LAB FOR REMOVAL OF THE REMAINING PORTION OF THE CATHETER FROM THE PT.
ON 7/29/96, AN ARTERIAL SHEATH WAS REMOVED APPLYING PRODUCT APPLIED TO THE RIGHT FEMORAL ARTERY. THE ARTERIAL SHEATH WAS REMOVED AND THE SHEATH INSERTED. ONE PLUG WAS INSERTED. WHEN THE SECOND PLUG WAS INSERTED THE ASSEMBLY WAS REMOVED, THERE WAS NO SHEATH ON IT. THE DR CHECKED A NEW ASSEMBLY AND NO SHEATH WAS SEEN ON IT; HE ASSUMED THERE WAS NONE AND RELEASED THE PT AFTER HE CAREFULLY EXAMINED HER AND FOUND NO SHEATH. ON 7/30/96 CO REP EXAMINED THE DEVICE AND CONFIRMED THE SHEATH WAS MISSING. ON 7/31/96 THE DR PERFORMED A SONOGRAM ON THE PT AND CONFIRMED THE SHEATH WAS IN HER LEG. 8/1/96 THE SHEATH WAS REMOVED SURGICALLY.
PT WAS HAVING AN ELECTROPHYSIOLOGY STUDY DONE FOR THE DIAGNOSIS OF SUPRAVENTRICULAR TACHYCARDIA. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE PT DEVELOPED A WIDE QRS TACHYCARDIA SUSPECTED TO BE VENTRICULAR TACHYCARDIA. NO STIMULATION WAS BEING PERFORMED AT THIS TIME. UPON RETRIEVAL AND EXAM OF THE TACHYCARDIA, IT WAS DISCOVERED TO HAVE BEEN CAUSED BY SPURIOUS PACING FROM THE PROGRAMMABLE CARDIAC STIMULATOR. THE PT WAS IMMEDIATELY DISCONNECTED FROM THE STIMULATOR. UPON EXAM OF THE STIMULATOR, IT WAS FOUND TO NOT BE FUNCTIONING PROPERLY. ALL OF THE CHANNEL OUTPUT LIGHTS WERE ON AND THE DISPLAY WAS DIMMED AND GARBLED. POWERING THE SYSTEM OFF AND THEN ON DID NOT RECTIFY THE SITUATION. THE STIMULATOR WAS TAKEN OUT OF SERVICE. IN FURTHER EXAM OF THE RECORDING FROM THE STUDY, IT   WAS FOUND THAT THE WIDE QRS TACHYCARDIA WAS CAUSED BY APPROX. SIX SECONDS OF PACING FROM THE STIMULATOR AT AN INTERVAL OF APPROX. 8 MILLISECONDS. FURTHER EXAM OF TRACINGS FROM PREVIOUS FOUR TO FIVE MINUTES SHOWED INTERMITTENT SPURIOUS PACING FROM THE STIMULATOR.
PT UNDERGOING RIGHT THORACOSCOPY AND LOBECTOMY VIA ENDOSCOPE. SURGEON USING STAPLER TO RESECT LUNG TISSUE. INSTRUMENT DID CUT TISSUE BUT FAILED TO STAPLE TISSUE WHEN FIRED. STAPLES NOT RELEASED, SO MASSIVE BLEEDING ENSUED. PROCEDURE CONVERTED TO OPEN THORACOTOMY AND PT TRANSFUSED 4 UNITS OF BLOOD. PT TAKEN TO ICU POST-OP. FAMILY INFORMED OF EVENTS BY SURGEON. PT STABLE IN ICU. OPEN THORACOTOMY AND TRANSFUSIONS WERE NECESSARY DUE TO PRODUCT FAILURE. STAPLER SEQUESTERED IMMEDIATELY AND SENT TO ECRI FOR PRODUCT INVESTIGATION. MFR NOTIFIED. FDA MEDWATCH REPORT FILED 8/23/96.
PT UNDERWENT INITIAL IMPLANT 4/10/87. REVISION OF IMPLANT PERFORMED ON TWO OCCASIONS: 8/28/92 AND 1/19/95. PT CONTINUES TO HAVE RECURRING INCONTINENCE. IMPLANT-REMOVED AND NEW SPHINCTER IN PLACE.
ORIGINAL IMPLANT WAS IN 1990. PT DID WELL IN THE BEGINNING  BUT BEGAN HAVING DIFFICULTY WITH CONTROL REQUIRING PROTECTIVE DEVICES ON A DAILY BASIS. URODYNAMIC STUDY REVEALED NO EVIDENCE OF DETRUSOR INSTABILITY. CYSTOSCOPY DEMONSTRATED NO EVIDENCE OF WITHDRAWAL EROSION, NO EVIDENCE OF BLADDER NECK CONTRACTURE, THE BLADDER ITSELF APPEARED NORMAL. SCHEDULED FOR REVISION, REPLACEMENT OR ADDING A SECOND SPHINCTER. DEVICE WAS REPLACED 8/6/96.
BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMIES.
REPOSITION BILATERAL BREAST IMPLANTS. EXCHANGE IMPLANTS.
WHILE ATTEMPTING TO USE THE CATHETER OF CO'S COMPACT SUCTION UNIT IN A CODE SITUATION WHEN PT WHO WAS EXPIRING WAS VOMITING AND ATTEMPTED TO SUCTION; IT WORKED ABOUT 10 SECONDS AND THEN STOPPED. HAD TO GET A WALL SUCTION TO THE PT CARE AREA AND THEN ABLE TO SUCTION. IT DID NOT DIRECTLY CAUSE THE DEMISE OF THE PT: BUT CONTRIBUTED TO SLOWER ACCESS TO SUCTION IN EMERGENCY SITUATION. FOLLOW UP SHOWED THAT THE RUBBER O RING IN THE UNIT WAS BROKEN. THIS WAS NOT FOUND WITH THE REGULAR EQUIPMENT CHECKS (EVERY 24 HRS) AS IT HAD TO FUNCTION FOR A SHORT TIME (ABOUT 15 SECONDS) BEFORE IT BROKE. HOSP IDENTIFIED IT WITH THREE OTHER UNITS IN USE ON CRASH CARTS AND EACH WERE REPLACED IMMEDIATELY. THE UNITS ARE 5 YRS OLD AND ELECTRICALLY WERE CHECKED BY BIOMEDICAL SERVICES EVERY 6 MONTHS; AS WELL AS CHECKS BY NURSING EVERY 24 HRS FOR FUNCTIONING TO CAPACITY AND BATTERIES NOT ON PM, NOW ARE TO BE REPLACED AND ARE NOW ON A REGULAR PM TO REPLACE EVERY YEAR PER MAINTENANCE. CO NOTIFIED RE: O RINGS OF SAME. NEW EQUIPMENT ORDERED AND TEMPORARY WALL VACUUM SUCTIONS PLACED INTO SERVICE UNTIL NEW EQUIPMENT INTO PLACE. THIS WAS EVALUATED BY PHYSICIANS CARING FOR PTS AS WELL AS MAINTENANCE AND SAFETY DIRECTOR. O RINGS WERE REPLACED BUT WILL AWAIT RESPONSE FROM CO. (COPY OF SAME REPORTED TO CO, AND NEW EQUIPMENT ORDERED). ALL REMOVED FROM SERVICE FOR NOW.
DURING A LENS IMPLANTATION PROCEDURE, THE LENS BROKE INTO THREE PIECES. DURING THE RETRIEVAL OF THESE PIECES, THE IRIS OF THE PT'S LEFT EYE WAS LACERATED. THE AREA WAS SUTURED AND A NEW LENS IMPLANTED WITHOUT FURTHER INCIDENT. THE LENS MFR WAS NOTIFIED.
CLIENT RECEIVED A "REDDISH-STRIPE" DOWN THE MID SECTION OF HER BACK. APPROX. 1 TO 2 INCHES WIDE.
THE DIALYZER DEVELOPED A BLOOD LEAK DURING ITS FIRST USE WITHIN 5 MINUTES OF INITIATING TREATMENT. THE ENTIRE SYSTEM WAS DISCARDED. EBL>250CC. THE DIALYZER HAD BEEN AIR PRESSURE TESTED DURING PREPROCESSING AND PASSED.
A MARKETING SURVEY WAS RECEIVED FROM A PT WHO WAS TREATED ON 7-9-96 TO THE NASOLABIAL FOLDS AND A SCAR ON THE LEFT CHIN. LATER THAT EVENING, THE PT APPLIED A 5% GLYCOLIC ACID CREAM AND CELEX-C (VITAMIN C) CREAM TO HER FACE. SHE HAD USED THE PRODUCTS FOR SEVERAL MONTHS. ON 7-10-96, THE PT DEVELOPED ERYTHEMA, SWELLING AND ITCHING AT ALL TREATMENT SITES. THE SITE OF THE SKIN TEST REMAINED ASYMPTOMATIC. SHE WAS SEEN BY HER PHYSICIAN LATER THAT DAY. HE BELIEVED THE PT HAD DEVELOPED A HYPERSENSITIVITY TO COLLAGEN AND PRESCRIBED PREDNISONE. ON 7-12-96, THE PT CALLED THE PHYSICIAN AND SAID SHE WAS UNABLE TO TOLERATE THE PREDNISONE AND WAS TOLD TO DISCONTINUE THE MEDICATION. WITHIN ONE WEEK OF TREATMENT, THE LOCAL SYMPTOMS HAD RESOLVED. THE PT WAS SEEN RECENTLY AND REMAINS ASYMPTOMATIC. THE PHYSICIAN WAS UNSURE IF THE SYMPTOMS REPRESENTED A HYPERSENSITIVITY TO COLLAGEN OR CONTACT DERMATITIS DUE TO THE APPLICATION OF THE TOPICAL CREAMS OVER FRESHLY TREATED COLLAGEN SITES.
PT EXPERIENCED "A SLIDING FEELING IN HIP". AFTER REMOVAL, FOUND OUT THE LINER WAS WORN OUT. ALSO REMOVED A FEMORAL HEAD.
DURING AN INCIDENT INVOLVING AN APPROX. 68 YR OLD MALE HAVING TROUBLE BREATHING, THE CREW REPORTEDLY COULD NOT APPLY PADS TO THE PT. WHEN THEY TRIED TO REMOVE THE LINER FROM THE FOAM SURFACE, THE LINER STUCK TO THE FOAM AND THE PAD TORE APART. THE CREW RAN OUT OF PADS AND COULD NOT USE THEIR DEFIBRILLATOR. THE PT WAS PRONOUNCED AT A HOSP.
WHILE ATTEMPTING TO SNARE AND REMOVE A POLYP, THE SNARE BECAME EMBEDDED IN THE COLON THEREBY MAKING SNARE RETRIEVAL IMPOSSIBLE. THE PT WAS TAKEN TO SURGERY TO REMOVE THE SNARE. AT THIS TIME CO DOES NOT KNOW IF THE HOSPITAL WILL BE RETURNING THE DEVICE FOR EVAL.
THE PT HAD SURGERY ON 8/2/96 AFTER RECEIVING INAPPROPRIATE SHOCKS DUE TO THE SENSE PACE LEAD DISLODGING. IT WAS STATED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.
LEAD HAD A HIGH IMPEDANCE READING AND WAS EXPLANTED ON 7/23/96. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORM TO SPECIFICATION.
A PT WAS IN A HOSPITAL BED WITH GUARD RAILS UP AND WEARING A CHEST RESTRAINT BECAUSE HE HAD BEEN COMBATIVE DUE TO ALZHEIMER'S DISEASE. HE WAS CHECKED AT 11:00PM AND WAS FINE. AT 11:25PM HE WAS FOUND HANGING OVER THE RAIL BY THE RESTRAINT. CPR WAS UNSUCCESSFUL AND HE WAS PRONOUNCED DEAD AT 11:53PM.
THIS REPORT IS BASED ON INFO SUPPLIED TO US WITHOUT OUR INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS OR RELATIONSHIP TO THE PRODUCT. WE ARE JUST RESPONDING TO THIS EVENT AS REQUIRED BY LAW. FREQUENCY AND SEVERITY :N,U,N,U.  CO IS ATTEMPTING TO LOCATE THE SUBJECT DEVICE, INSPECT IT AND EVALUATE THE DEVICE.
PT PRESENTED WITH PAIN AND SWELLING. SCOPED KNEE FIRST TO SEE IF ONLY POSSIBLE SOFT TISSUE PROBLEM. FOUND PIECES OF LOOSE POLY. OPENED KNEE, LARGE AREA BELOW SURFACE OF DECOMPOSITION ON LATERAL SIDE. SEVERE POLY DELAMINATION ON MEDIAL SIDE. REMOVED BASEPLATE WHICH HAD BONE CEMENT DEMARCATION ON ANTERIOR MEDIAL UNDERSIDE, RECUT TIBIA AND CEMENTED NEW BASEPLATE AND INSERT.
THE FILTER DOME AND LEGS DID NOT FORM PROPERLY WHEN RELEASED. AFTER SEVERAL ATTEMPTS, THE FILTER WAS REMOVED USING A 7FR COLD SNARE SHAPED INTO A DIAMOND AND ADJUSTED TO A GOOSENECK ANGLE.
PER THE PT'S IMPLANT SURGEON, THE PT DEVELOPED A PURULENT DISCHARGE OUT OF THE RIGHT EAR WHICH WAS TREATED WITH ANTIBIOTICS (SEEN BY SURGEON ON 4/5/96). ON 4/9/96, EXPLORATORY SURGERY WAS DONE AND IT WAS NOTED THAT THE ELECTRODE ARRAY WAS LYING IN THE EAR CANAL. THE ARRAY HAD DESECNDED THROUGH A PERFORATED TYMPANIC MEMBRANE. REVIEW OF RADIOGRAPHY SUGGESTED THE ELECTRODE HAD ERODED THE POSTERIOR CANAL WALL. ON 4/16/96 THE IMPLANT WAS REMOVED AND THE GRANULATION TISSUE AND INFECTED MATERIAL WAS REMOVED. THE EAR WAS PACKED WITH ANTIBIOTIC OINTMENT. THE TYMPANIC MEMBRANE AND BONY CANAL HAVE COMPLETELY HEALED. THE HEALTHCARE PROFESSIONAL HAD BEEN INFORMED THAT THE EXPLANTED DEVICE SHOULD BE RETURNED TO CO.
EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. EVENT OCCURING MORE FREQUENTLLY THAN USUAL? NO. EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO.
PT RIGHT EYE WAS BURNING, ITCHING WITH REDNESS TOTAL DURATION OF USE (MONTHS): 2 WEEKS; NUMBER DAYS WORN: 1;
PT'S LEFT LENS BECAME UNCOMFORTABLE AND REMOVED IT ON 8/5/96. UPON EXAMINATION BY DOCTOR STAINING WAS FOUND ON LEFT EYE AT 10 O'CLOCK. DOCTOR DIAGNOSIS CORNEAL ULCER. ADMINISTERING CILOXAN 0.3% EYE INVOLVED: OS; REFRACTION: MYOPIA; TOTAL DURATION OF USE (MONTHS): 2; NUMBER DAYS WORN;    SLEEPS IN 3 MIGHTS AND OFF 11 NIGHTS; LAST VISIT TO PRACTITIONER PRIOR TO SYMPTOMS: 6/10/96. TYPE LENS CARE SYSTEM WAS USED: DISINFECTING SYSTEM WAS USED; HOMEMADE SALINE USED: NO; NUMBER OF DAYS WORN BETWEEN CLEANING AND DISINFECTING: 6; NUMBER OF DAYS BETWEEN CLEANING AND SYMPTOMS: 4; NUMBER DAYS BETWEEN SYMPTOMS AND CALLING DR: 1; SELF TREATMENT BY PT: REMOVED LENS ABOUT 12 NOON ON 8/4/96; HAND WASHING BEFORE LENS MANIPULATION: UNK; ULCER LOCATION: 10 O'CLOCK; VISUAL ACUITY BEFORE SYMPTOMS: 20/15; VISUAL ACUITY AFTER SYMPTOMS: 20/15; VISUAL ACUITY AFTER SYMPTOMS: 20/15; RESULTS OF CORNEAL BIOPSY AND/OR SCRAPINGS: NA; RESULTS OF CULTURE: NONE TAKEN.
EVENT FREQUENCY IS NOT ADDRESSED IN PRODUCT LABELING. EVENT IS NOT OCCURRING MORE FREQUENTLY THAN USUAL. EVENT SEVERITY IS NOT ADDRESSED IN PRODUCT LABELING. EVENT SEVERITY IS NOT GREATER THAN USUAL FOR PRODUCT.
ON 8/5/96 PT COMPLAINED OF SLIGHT SENSATION IN RIGHT EYE. DOCTOR DIAGNOSIS CORNEAL ULCER AND ADMINISTERED GENTAMYCYN. NUMBER DAYS BETWEEN CLEANING AND SYMPTOMS: NEW LENS RESULTS OF BIOPSY SCRAPINS; UNK;
PT CAME TO EMERGENCY DEPARTMENT ON 7/12/96 AND WAS DIAGNOSED WITH A DISTAL RADIUS FRACTURE. AND SPLINT WAS APPLIED. ON 7/22/96 THE PT RETURNED TO THE ED WITH A HEALING PARTIAL THICKNESS BURN.
IN A TELEPHONE CONVERSATION WITH SOURCE SHE COULD NOT IDENTIFY THE SPECIFIC PRODUCT. THERE ARE SEVERAL DIFFERENT TYPES OF SPLINT ROLL THAT ARE UNOFFICIALLY CALLED SPLINTS. THEREFORE, CO HAS NO PRODUCT NUMBERS, LOT NUMBERS, ETC. SOURCE ALSO STATED THAT THE DR WAS NOT CERTAIN OF THE SOURCE OF THE BURN.
PT WAS TREATED ON 12/7/95 IN NASOLABIAL FOLDS AND GLABELLA. ON 12/11/95, THE PT PRESENTED WITH A "GREYISH-PURPLE" BRUISE AND ERYTHEMA AT THE GLABELLAR TREATMENT SITE; EXACT DATE OF ONSET UNKNOWN. THE PHYSICIAN DIAGNOSED A NECROSIS; TOPICAL BACITRACIN AND ORAL KEFLEX WERE PRESCRIBED. ON 12/14/95, THE PT PRESENTED WITH DECREASED BRUISING ERYTHEMA AT THE GLABELLAR TREATMENT SITE. ON 1/18/96, SHE PRESENTED WITH "MINIMAL SKIN LOSS" AT THE GLABELLAR TREATMENT SITE. ON 2/5/96, THE PT PRESENTED WITH A SCAR AT THE GLABELLAR TREATMENT SITE. ON 4/8/96, A SCAR REVISION WAS PERFORMED. AS OF 5/20/96, THE TREATMENT SITE WAS "WELL HEALED".
PAT. PROB. CODE: 1971-LABELED. PAT. PROB. CODE: 2060-LABELED.
RESIDENT WAS IN SITTING POSITION ON CTR OF LIFT WITH LEGS DANGLING TO THE FRONT (OFF THE LIFT). THE CUSHION THE RESIDENT WAS SITTING ON (CENTER) SLID FORWARD WITH RESIDENT, ALLOWING THE RESIDENT TO FALL TO THE FLOOR.
UPON INSPECTION DEVICE WAS FOUND TO BE IN GOOD CONDITION AND WORKING PROPERLY. THE CTR CUSHION ON WHICH THE RESIDENT WAS SEATED WAS NOT PROPERLY SECURED TO THE CTR OF THE LIFT. USER ERROR CAUSED EVENT. THE CUSTOMER HAS BEEN INSTRUCTED TO REFER TO THE OPERATIONAL MANUAL FOR THE DEVICE FOR PROPER USE. FREQUENCY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. FREQUENCY IS GREATER FOR THIS EVENT, THAN IS USUAL. SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. SERVERITY IS GREATER FOR THIS EVENT THAN IS USUAL. ADD'L INFO WILL NOT PROVIDED AFTER 15-DAY RPT.
IMPLANT WAS PLACED ON 6/19/96. PT CAME IN ON 7/9/96 AND IMPLANT WAS LOOSE. IMPLANT WAS REMOVED ON 7/12/96. DR. WILL WAIT FOR BONE TO FILL IN BEFORE ANOTHER IMPLANT IS PLACED. TOOTH #5.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. AS THE IMPLANT HAS NOT BEEN RETURNED, CO CANNOT BE SURE IT IS A CO PRODUCT. THE LIKELY CAUSE OF FAILURE IS THE REPORTED INFECTION, COMPOUNDED BY THE PATIENT'S SMOKING. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS.
IMPLANT PLACED ON 1/18/96. SOME PAIN, NO SWELLING, NO INFLAMMATION, LOOSE. DID NOT INTEGRATE. 3 IMPLANTS WERE PUT IN, 2 ARE INTEGRATED.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE IMPLANT HAS NOT BEEN RETURNED. CO CANNOT BE SURE IT IS A CO PRODUCT.
A PT RECEIVED HER FIRST TREATMENT ON 7/12/96 WITH 2 FORMULATIONS OF COLLAGEN IN THE VERMILION BORDERS AND NASOLABIAL FOLDS. IMMEDIATELY AFTER THE TREATMENT, THE PT NOTED PAIN AT THE TREATMENT SITES WHICH SHE ATTRIBUTED TO THE INJECTION PROCEDURE. THE PAIN RESOLVED SPONTANEOUSLY WITHIN 24 HRS. ON APPROX. 7/16/96, SHE NOTED A "COLD SORE" AT THE UPPER VERMILLION BORDER TREATMENT SITES: THE PHYSICIAN DIAGNOSED HERPES SIMPLEX AND PRESCRIBED ZOVIRAX. ON APPROX. 7/19/96, THE PT NOTED A "WHITE BUMP" AT HER LEFT CHEEK; A CONSULTING PHYSICIAN (NAME REFUSED) DIAGNOSED A SEBACEOUS CYST; EXCISION WAS PERFORMED. THE CONSULTING PHYSICIAN DID NOT BELIEVE THAT THE SEBACEOUS CYST WAS RELATED TO COLLAGEN. THE PT ALLEGED THAT AS OF       8/23/96, THE VERMILION BORDERS REMAINED "FIRM AND TENDER" ESPECIALLY WHEN PURSING HER LIPS OR OPENING HER MOUTH WIDE. SHE ALSO ALLEGED THAT CORRECTION AT THE NASOLABIAL TREATMENT SITES HAD COMPLETELY DISAPPEARED.
PAT. PROB. CODE: 1907-LABELED. PAT. PROB. CODE: 1994-LABELED. PAT. PROB. CODE: 1898-LABELED.
TIP WAS ALMOST BROKEN OFF. PRODUCT WAS BEING USED IN A DUCT, NOT IN URETHRA. HEALTH WORKERS DID NOT NOTICE TIP ALMOST OFF. SINCE PRODUCT WAS BEING USED IN A DUCT THERE WAS NO DAMAGE OR INJURY TO PT AS SIZE OF DUCT IS LARGER THAN URETHRA.
FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. FREQUENCY GREATER FOR THIS EVENT THAN USUAL? UNK. SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO.  SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? UNK.  PER TELEPHONE CONVERSATION WITH THE CUSTOMER, THE DEVICE WAS USED IN A DUCT AND NOT IN THE AREA OF INTENDED USE (URETHRA). THE PROC WAS COMPLETED WITHOUT INCIDENT OR INJURY AND IT WAS ONLY UPON REMOVAL OF THE DEVICE THAT THE OPERATOR NOTICED THE TIP WAS ALMOST BROKEN. THE REPORTER HAS STATED THAT THE TIP OF THE DEVICE WAS "ALMOST BROKEN OFF" PRIOR TO THE PROCEDURE.
PT WAS SKIN TESTED ON 5/27/96 AND WAS TREATED ON 6/24/96 WITH 2 FORMULATIONS OF COLLAGEN IN THE GLABELLA, NASOLABIAL FOLDS, VERTICAL LIP LINES, AND MARIONETTE LINES. IMMEDIATELY AFTER THE TREATMENT, ERYTHEMA, INDURATION, AND TENDERNESS WERE NOTED AT THE TREATMENT AND SKIN TEST SITES. A HYPERSENSITIVITY WAS DIAGNOSED; ANTIBIOTICS WERE PRESCRIBED.
ON 9/18/96, FOLLOW UP INFO WAS RECEIVED; THE PATIENT HAD A FIVE DAY COURSE OF ORAL ANTIBIOTICS WITH NO APPARENT RELIEF FROM SYMPTOMS. ON 3/3/97, THE PATIENT WAS CONSIDERED LOST TO FOLLOW UP.
PT EXPERIENCED DISCOMFORT OS EYE AFTER REMOVING LENS ON 8/14/96. PT REPORTED TO DOCTOR PHOTOPHOBIC AND RED EYE. WEARING GLASSES, DR REPORTER    OS CORNEAL INFILTRATE AND ADMINISTERED GENTAMICIN GLH. EYE INVOLVED; OS. REFRACTION; MYOPIA. TOTAL DURATION OF USE(MONTHS);17. NUMBER DAYS WORN;1. LAST VISIT TO PRACTITIONER PRIOR TO SYMPTOMS;11/27/95. TYPE LENS CARE SYSTEM USED; CHEMICAL. DISINFECTING SYSTEM WAS USED. HOMEMADE SALINE USED;NO. NUMBER DAYS WORN BETWEEN CLEANING AND DISINFECTING;1. NUMBER DAYS WORN BETWEEN CLEANING AND SYMPTOMS;1. NUMBER DAYS BETWEEN SYMPTOMS AND CALLING DOCTOR;1. SELF TREATMENT BY PT;NONE. HAND WASHING BEFORE LENS MANIPULATION;UNK. ULCER LOCATION;2 O'CLOCK 1MM FROM LIMBUS. VISUAL ACUITY BEFORE SYMPTOMS;20/25. VISUAL ACUITY AFTER SYMPTOMS; WITH GLASSES OD 20/20-2/OS 20/20-1. CULTURE; NONE TAKEN. RESULTS OF CORNEAL BIOPSY AND/OR SCRAPINGS;NA. CLINICAL DIAGNOSIS;CORNEAL ULCER.
EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO.  EVENT OCCURRING MORE FREQUENTLY THAN USUAL? NO.  EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO.  EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO.
ADMITTED 7/29/96  THRU ER COMPLAINED OF SHORTNESS OF BREATH; DIAGNOSIS RESPIRATORY INSUFFICIECNY PNEUMONIC. ARRESTED ON 8/2/96 STAFF PROCEEDED TO RESUSCITATE PT USING DEVICE. IT WAS LATER NOTED THAT THE MONITOR WAS NOT IN THE "PADDLE" MODE WHILE USING PADDLES; IT WAS IN THE LEAD II MODE WHICH CAME UP WHEN MACHINE WAS TURNED ON AND STAFF WAS TRAINED THAT MONITORING WITH PADDLES COULD BE DONE WITH LEAD II. WHEN IN FACT IN ORDER TO IDENTIFY RHYTHM WITH PADDLE-PADDLES MODE MUST BE ON MONITOR SCREEN.
ATTACHMENT CLIP, LEG END, CAME OFF HOIST, PT LIFTED (17 YR OLD FEMALE) WENT INTO SPASM. NO INJURY REPORTED.
FORIEGN RPTR IS TO SEND CLOSING REPORT, FORIEGN RPTR IS AS FOLLOWS: ARJO LTD ST. CATHERINE ST GLOUCESTER, ENGLAND GL12SL. FREQUENCY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. FREQUENCY IS GRATER FOR THIS EVENT, THAN IS USUAL. SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. SEVERITY IS GREATER FOR THIS EVENT THAN IS USUAL. ADD'L INFO WILL NOT BE PROVIDED AFTER 15-DAY RPT.
BONE VOID FILLER GRANULES WERE USED TO REPAIR A RIGHT ANKLE ARTHRODESIS IN 12/95. SUBSEQUENTLY, THE PT EVIDENCED AN INFECTION. IN 5/96, THE SITE WAS DEBRIDED AND A PORTION OF THE GRAFT MATERIAL AND SURROUNDING TISSUE WERE REMOVED. SUBSEQUENT SWABBING OF THE REMOVED GRAFT AND TISSUE REVEALED PROTEUS MIRABILIS AS THE SUSPECTED CAUSATIVE AGENT FOR THE INFECTION. IT WAS STATED BY THE NURSE THAT THERE WAS NO REASON TO SUSPECT THAT FILLER WAS IN ANY WAY RESPONSIBLE FOR THE INFECTION. IT WAS NOTED THAT THE PT'S ANKLE HAD BEEN OPERATED ON AT LEAST FOUR TIMES.
ACTUAL DEVICE NOT RETURNED, HOWEVER, 86= REVIEW OF DEVICE HISTORY RECORD SHOWED THAT ALL PRODUCT IN THIS LOT WAS MFG, PROCESSED AND STERILIZED IN ACCORDANCE WITH ESTABLISHED AND VALIDATED PROCEDURES AND SPECIFICATIONS. THE RUN DATA SHEET AND CERTIFICATE OF IRRADIATION SHOWED ALL PRODUCT WAS PROCESSED WITHIN PARAMETERS. NO EVIDENCE OF A BREAKDOWN IN SYSTEMS FOR PRODUCT PACKAGING OR STERILIZATION COULD BE FOUND.
THE HOIST DROPPED WITH A PT SITTING ON THE HOIST, SHE WAS SHAKEN BUT UNINJURED.
FORIEGN RPTR IS SENT FOLLOW-UP INFO, FOREIGN RPTR IS AS FOLLOWS: ARJO LTD ST. CATHERINE ST GLOUCESTER, ENGLAND GL12SL. FORIEGN RPTR HAS REQUESTED THAT RETURN OF OTTER GEAR BOX TO THIER FACILITY FOR INSPECTION. FREQUENCY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. FREQUENCY IS GREATER FOR THIS EVENT, THAN IS USUAL. SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. ADD'L IFNO WILL NOT BE PROVIDED AFTER 15-DAY RPT.
THE PT HAD ANOTHER CO'S TOTAL KNEE IMPLANTED ON 7/19/94. THE METHOD OF FIXATION FOR THE KNEE WAS CO'S BONE CEMENT. THE REPORTER ALLEGED THAT THE KNEE LOOSENED AND BROKE. THE BONE CEMENT WAS REMOVED AT THE SAME TIME THE KNEE WAS REVISED. THE DATE OF REVISION IS UNKNOWN.
SUMMARY OF EVAL: EVAL RESULTS INDICATED NO ABNORMALITIES WITH THE SPECIFIC BATCH OF CEMENT TESTED. THE ROOT CAUSE IS NOT ATTRIBUTED TO A PRODUCT QUALITY DEFICIENCY, BUT TO EXTERNAL FACTORS.
PT UNDERWENT CATARACT SURGERY ON 7/24/96, AND IMPLANTATION OF A INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE LENS TILTED SIDEWAYS DURING INSERTION AND FLIPPED IN THE PT'S EYE. THE SURGEON NOTED THAT THE POSTERIOR CAPSULE WAS TORN AND HE PERFORMED A VITRECTOMY.
THE SURGEON REMOVED THE LENS IN SEVERAL PIECES AND DISCARDED THEM. THEREFORE, WE ARE UNABLE TO EVALUATE OR DETERMINE IF THE LENS CONTRIBUTED TO THIS EVENT. THE SURGEON SAID THAT THE LENS EJECTED IN AN UNCONTROLLED MANNER AND CAUSED THE CAPSULE TEAR. THE RATE OF OCCURRENCE OF THIS EVENT CANNOT BE DETERMINED AS IT IS NOT ADDRESSED IN THE PRODUCT LABELING.
IMPLANT WAS PLACED ON 12/12/95 AND UNCOVERED ON 4/30/96. ALL SEEMED WELL. DR. PLACED STANDARD ABUTMENTS FOR HEALING. SOMETIME BETWEEN 7/10 AND 7/18/96 THE IMPLANT CAME OUT.
THE RETURNED IMPLANT WAS EVALUATED AND COMPARED TO BLUEPRINT. IT MET SPECS. THE PT'S REPORTED BRUXISM IS THE LIKELY CAUSE OF FAILURE.
CATHETER WAS INSERTED ON 8/2 AND BROKE OFF IN PT ON REMOVAL ON 8/4. SURGICAL REMOVAL WAS COMPLETED WITH NO PT COMPLICATIONS.
MANUFACTURER CONTROL NO. DC96-486 CO'S EVAL OF THE RETURNED 20 GAUGE CATHETER INDICATES THAT IT HAS BEEN CUT DURING USE. THE SEPARATION HAS OCCURRED AT A POINT 1/32" DISTAL TO THE HUB NOSE. THE CAUSE OF THE SEPARATION APPEARS TO BE FROM A SHARP OBJECT, SUCH AS A SCALPEL.
PLACED ON 1/30/96, PT REPORTED PAIN, SWELLING, REDNESS, 2/21/96: ANTIBIOTICS PRESCRIBED FOR 10 DAYS. IMPLANT AND 2 OTHERS SEEMED FIND AT SUBSEQUENT CHECK-UPS. WHEN DR. WENT TO UNCOVER, THIS IMPLANT CAME OUT.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO,NO,YES,NO. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE DIMENSIONALLY CORRECT. THE CAUSE OF FAILURE IS LIKELY THE REPORTED INFECTION, COMPOUNDED BY THE PT'S SMOKING.
H6, RESULTS-CODE 200 & CODE 400 (NOT ENOUGH INFO TO DETERMINE CAUSE).
THE CHAIR OF THE SCALE FELL OFF JIB AS THE PT WAS BEING LIFTED OUT OF THE BATH. THE CHAIR AND PT FELL INTO BATH BUT INJURY WAS NOT SUFFERED. THE CRADLE OF THE JIB IS DEFORMED ALLOWING THE CHAIR TO PULL OUT OF THE JIB SAFETY CATCH.
THE FOLLOWING IS A CLOSING OUT REPORT BY THE FOREIGN REPORTER'S INVESTIGATOR. INVESTIGATION: THE FRONT RIGHT HAND SIDE OF THE JIB PICK-UP HOOK WAS BENT FORWARD, ALTHOUGH THE SAFETY CATCH WAS WORKING THERE WAS ENOUGH ROOM FOR THE CHAIR UNIT TO LIFT OFF THE HOOK. OBSERVATIONS: THE INVESTIGATOR CONCLUDES THAT IT LOOKS LIKE THE HOIST WAS PUSHED INTO THE LOCKING POSITION AND KEPT BEING PUSHED UNTIL THE PICK-UP BENT AND THE CHAIR CAME OFF. CONCLUSIONS: USER ERROR. PRESSURE WAS EXERTED ON THE HOIST AFTER IT HAD REACHED ITS LOCKING POSITION WHICH WAS REQUESTED BY THE HOME AT THE TIME OF INSTALLATION. CORRECTIVE ACTIONS: THE OPERATING INSTRUCTIONS HAVE BEEN CONFIRMED FOR THE HOME.
H6. RESULTS-CODE 200& CODE 400 (NOT ENOUGH INFO TO DETERMINE CAUSE).
THE INJECTOR CONTAINS THE SOFTWARE PROMPT, "HAVE YOU EVACUATED ALL AIR FROM THE XXXML SYRINGE AND TUBING?". THIS QUESTION MUST BE ANSWERED BY THE OPERATOR BEFORE AN INJECTION CAN BEGIN. IN THIS INCIDENT, THE TECHNICIAN PRESSED THE "YES" BUTTON IN RESPONSE TO THE PROMPTED AIR QUESTION WITHOUT PHYSICALLY CHECKING THE SYRINGE AND TUBING AS INSTRUCTED. CONSEQUENTLY, THE INJECTION WAS STARTED WITH AN EMPTY PREFILLED SYRINGE FROM THE PREVIOUS PROCEDURE STILL IN THE INJECTOR AND THE PT RECEIVED 125ML OF AIR. THE PT EXPERIENCED NO PHYSICAL REACTIONS OR SYMPTOMS AND NO REMEDIAL ACTIONS WERE TAKEN BY THE HOSPITAL. IN AN 8/9/96 CONFERENCE CALL WITH THE HOSPITAL'S SP & CT SUPERVISOR, SHE ADMITTED "TECHNICIAN ERROR" WAS THE CAUSE OF THIS INCIDENT TO CO PERSONNEL. THE AREA SALES REPRESENTATIVE PERFORMED INSERVICE TRAINING TO THE HOSPITAL STAFF ON 8/14/96.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IS FREQUENCY GREATER FOR THIS EVENT THAN USUAL? NO. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IS SEVERITY OF THIS EVENT GREATER THAN LABELED? NO.  NEITHER THE SUBMISSION OF THIS OR OTHER INFO TO THE FDA PURSUIT TO 21 CFR 803 NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT THIS DEVICE IS DEFECTIVE OR ESTABLISHES THE EXISTENCE OF ANY CASUAL CONNECTION BETWEEN THIS DEVICE AND A DEATH OR SERIOUS INJURY.  H3: BAYFRONT'S SP & CT SUPERVISOR STATED THAT THIS EVENT WAS DUE TO "TECHNICIAN ERROR". 8/12/96 LF INFORMED BAYFRONT'S RISK MANAGEMENT THAT THIS EVENT IS CONSIDERED REPORTABLE UNDER MDR MANUFACTURER REQUIREMENTS.
DURING TREATMENT OF AN RCA LESION, FOLLOWING MULTIPLE ABLATION PASSES WITH SEVERAL BURR SIZES, IT BECAME APPARENT THAT THE GUIDE WIRE HAD FRACTURED. A STENT WAS PLACED IN ORDER TO HOLD THE DISTAL PORTION WHICH REMAINED IN THE PT.
BSC NORTHWEST ENGINEERS DID A PRELIMINARY INSPECTION OF THE GUIDE WIRE FRAGMENT AT HOSPITAL ON NOVEMBER 11,1998. ONLY THE PROXIMAL PORTION OF THE WIRE WAS AVAILABLE FOR EXAMINATION. THE WIRE APPEARED WITHIN SPECIFICATION. SEVERAL BENDS AND CURVES WERE APPARENT ESPECIALLY TOWARDS THE DISTAL END OF THE FRAGMENT. ON THE DISTAL PORTION, SEVERAL AREAS OF WEAR WERE ALSO FOUND. NO EVIDENCE OF WEAR CAUSED BY DIAMONDS FROM THE BURR WERE OBSERVED. THESE FINDINGS ARE CONSISTENT WITH DAMAGE CAUSED BY THE DRIVE SHAFT/BURR INTERACTING WITH THE WIRE.
A PT WAS BURNED IN THE NASAL CAVITY DURING A NASAL PROCEDURE. THE BURN     MEASURED APPROX 1/4" X 1/4" AND WAS DEBRIDED. THE FORCEPS ARE TWEEZER TYPE (MFG UNKNOWN).
THE RETURNED GENERATOR WAS TESTED AND FOUND PROPERLY AND WITHIN ALL SPECS. THE BIPOLAR FOOTSWITCH WAS ALSO RETURNED AND FOUND TO FUNCTION PROPERLY. THE BIPOLAR FORCEPS WERE NOT MANUFACTURED BY CO. THE CUSTOMER WAS CONTACTED AND INDICATED THAT A GROUNDING PAD HAD BEEN APPLIED FOR THE BIPOLAR PROC. THE GENERATOR MANUAL ADDRESSED THE USE OF A GROUNDING PAD WITH BIPOLAR PROCEDURES(ATTACHED).
WHEN PT WAS BEING TRANSFERRED BACK TO ROOM, SHE ROLLED OVER (OR SHIFTED WEIGHT) CAUSING RESTRAINTS TO DISCONNECT AND PT FELL TO THE FLOOR. PT HIT THE FLOOR WITH RIGHT HIP AND SHOULDER, CAUSING A FRACTURE IN BOTH OF THESE TWO AREAS.
THE FOLLOWING WAS DISCOVERED AT THE TIME OF INSPECTION. CONDITION OF LIFT IS GOOD, CONDITION OF STRAPS USED AT TIME OF INJURY IS POOR, AND INCORRECT STRAPS WERE USED. REPLACED USED AND INCORRECT STRAPS WITH NEW AND CORRECT STRAPS. USER ERROR AND IMPROPER MAINTENANCE OF BELTS WERE CAUSE OF ACCIDENT. CUSTOMER HAS BEEN INSTRUCTED REVIEW THE OPERATIONAL AND MAINTENANCE MANUAL. FREQUENCY OF OCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. FREQUENCY IS GREATER FOR THIS EVENT, THAN IS USUAL. SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELEING. SEVERITY IS GREATER IS GREATER FOR THIS EVENT THAN IS USUAL. ADD'L INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT.
PT WAS BEING TRANSFERED TO WHIRPOOL CHAIR WHEN THE PT ATTEMPTED TO GET UP. THE PT FELL TO THE FLOOR WHEN MAKING THE ATTEMPT TO GET AND SUFFERED A 1 CM LACERATION ON RIGHT SIDE OF FOREHEAD. NO OTHER INJURIES OCCURRED.
PT WAS IMPROPER CANDIDATE AS OPERATOR COULD NOT RESTRAIN WHEN PT ATTEMPTED TO GET UP, WHEN BEING TRANSFERED. BOTH TUB AND LIFT WERE IN NEED OF MAINTAINANCE WHICH WAS PERFORMED ON 7/30/96, MAKING UNIT SERVICABLE AGAIN. USER ERROR. CUSTOMER HAS BEEN INSTRUCTED TO REFER TO THE OPERATIONAL AND MAINTAINANCE MANUAL FOR REVIEW.
THE ATTENTION OF THE BUREAU EMI WAS CALLED BY A CENTRAL HOSP THROUGH SURVEYING INCIDENTS OF UTILIZATION OF THE MONITORS IN QUESTION. RPTR HAS KNOWLEDGE OF A SERIOUS INCIDENT AND OTHER RISKY INCIDENTS REGARDING THE UTILIZATION OF SURVEILLANCE MONITORS. IN EFFECT THE O2 SATURATION MODULE DIDN'T SET OFF THE ALARM WHEN THE PT WAS IN A STATE OF HYPOXIA. THE USER HAD NOT SET ANY INHIBITION PARAMETERS. THROUGH INVESTIGATION, TWO PROBLEMS WERE DISCOVERED. THE FIRST CONCERN IS THE FAILURE OF THE ALARM TO SOUND. THE SECOND CONCERN IS A PROBLEM  WITH AN INSUFFICIENT CONNECTION OF THE ALARM. THE DISTRIBUTOR ISSUED A SAFETY ALERT IN COOPERATION WITH THE MFR TO INSTRUCT USER FACILITIES ON PROPER TESTING OF THE EQUIPMENT BEFORE USE. THE SAFETY ALERT INDICATES THAT THE USER SHOULD NOT EMPLOY THE DEVICE IF IT DOES NOT PASS THE NEWLY ISSUED TESTING GUIDELINES. THE RPTR HAS SENT A BULLETIN TO MULTIPLE USER FACILITIES INFORMING THEM OF THE PROBLEM AND REQUESTING THAT THEY INFORM THE RPTR OF ANY SIMILAR EXPERIENCES WITH THE DEVICE. (REFERENCE MW4001438.)
RPTR REFERRED TO AN INCIDENT INVOLVING A SIMILAR DEVICE WHERE A PT WAS HYPOXIC BUT THE ALARM DID NOT SOUND AND NO INHIBITION PARAMETERS HAD BEEN SET BY THE USER. RPTR IS CONCERNED AS THE TWO DEVICES ARE OF "IDENTICAL CONCEPTION " WITH THE EXCEPTION THAT THIS MODEL IS ALSO CAPABLE OF MEASURING INVASIVE PRESSURE AND THEREFORE THIS DEVICE IS SUBJECT TO THE SAME FAILURE. THE DISTRIBUTOR ISSUED A SAFETY ALERT IN COOPERATION WITH THE MFR TO INSTRUCT USER FACILITIES ON PROPER TESTING OF THE DEVICE BEFORE USE. THE SAFETY ALERT INDICATES THAT THE USER SHOULD NOT EMPLOY THE DEVICE IF IT DOES NOT PASS THE NEWLY ISSUED TESTING GUIDELINES. THE RPTR HAS SENT A BULLETIN TO MULTIPLE USER FACILITES INFORMING THEM OF THE PROBLEM AND REQUESTING THAT THEY INFORM THE RPTR OF ANY SIMILAR EXPERIENCES WITH THE DEVICES. (REFERENCE MW4001437.)
SHEATH IN WAS PLACE IN RIGHT FEMORAL VEIN FOR CARDIAC CATHETERIZATION. INSERTION OF THERMODILUTION CATHETER IN SAME VEIN THROUGH SHEATH, POSITIONING OF CATHETER REQUIRED PULLING BACK OF CATHETER AND DURING THAT ACTIVITY THE SHEATH SHEARED WITH A PORTION OF THE SHEATH REMAINING IN THE FEMORAL VEIN. ATTEMPTED CUT DOWN TO RETRIEVE REMAINING CATHETER IN SURGERY. CATHETER HAD THEN TRAVELED, WAS LOCATED IN LEFT PULMONARY ARTERY. RETRIEVED UNDER FLUOROSCOPY IN SPECIAL PROCEDURES DEPT BY RADIOLOGIST. THREE (3) INCH FOREIGN BODY RETRIEVED UNDER PROCEDURE DESCRIBED. PT REMAINS HOSPITALIZED UNDER OBSERVATION.
A RADIAL ARTERY CATHETER BROKE OFF AND REMAINED IN THE RADIAL ARTERY WHEN THE CATHETER WAS REMOVED FROM THE ARTERY. THE 1-1.25 INCH PIECE OF THE CATHETER WAS SURGICALLY REMOVED FROM THE PT.
A PT WAS TREATED ON 8/15/96. THE PHYSICIAN HAD INJECTED 0.1CC INTO THE NASOLABIAL FOLD WHEN THE HUB OF THE NEEDLE BECAME BRIEFLY DISCONNECTED FROM THE SYRINGE, AND 0.9CC OF MATERIAL SQUIRTED OUT. HE REMOVED THE NEEDLE AND WIPED THE COLLAGEN FROM THE PT'S FACE. HE OBTAINED ANOTHER SYRINGE AND COMPLETED THE TREATMENT. IMMEDIATE BRUISING WAS ATTRIBUTED BY THE PHYSICIAN TO THE INJECTION PROCEDURE AND THE PT'S ASPIRIN INTAKE; THE PT DESCRIBED FOUR DARK PURPLISH-BLACK MARKS THE SIZE OF A PENCIL ERASER AT THE SUPERIOR END AND THE MIDDLE PORTION OF BOTH NASOLABIAL FOLDS. THE PHYSICIAN ALSO NOTED REDNESS AND SWELLING IMMEDIATELY AFTER THE TREATMENT. THE PHYSICIAN DID NOT BELIEVE THE MALFUNCTION CONTRIBUTED TO THE BRUISING, REDNESS OR SWELLING; HE ATTRIBUTED THESE SYMPTOMS TO THE INJECTION PROCEDURE. ICE PACKS WERE APPLIED TO THE AREAS AFTER THE TREATMENT. APPROX NINE HRS AFTER THE TREATMENT, THE PT DEVELOPED A FEVER OF 99.9F AND A HEADACHE AT THE BASE OF THE NECK. THE PHYSICIAN DID NOT BELIEVE THE FEVER AND HEADACHE WERE RELATED TO THE COLLAGEN; NO DIAGNOSIS WAS GIVEN. THE PT DID NOT KEEP A SCHEDULED APPOINTMENT FOR 8/19/96; SHE REPORTED BY TELEPHONE ON 8/19/96 THAT HER FEVER AND HEADACHE WERE GONE AND THERE WAS NO REDNESS OR INFLAMMATION AND VERY LITTLE BRUISING AT THE NASOLABIAL FOLDS. MORE COLLAGEN HAD BEEN INJECTED INTO ONE NASOLABIAL FOLD AND THERE WAS A SLIGHT RIDGE OF COLLAGEN MATERIAL VISIBLE; THE PT WAS INSTRUCTED TO MASSAGE THE AREA. THIS EVENT IS BEING REPORTED AS AN MDR BECAUSE IT COULD RESULT IN A SERIOUS INJURY IF IT WERE TO RECUR.
PAT. PROB. CODE: 1754-LABELED, PAT. PROB. CODE: 1436-LABELED, PAT. PROB. CODE: 1858-LABELED, PAT. PROB. CODE: 1880-LABELED, DEV. #2 PROB CODE: 1415-LABELED.
UPON REMOVAL THE TIP OF THE CATHETER WAS MISSING. IMAGING REVEALED TIP IN THE HEART. PT WAS SENT TO RADIOLOGY AND A 4" CATHETER SECTION WAS REMOVED SUCCESSFULLY. THE CATHETER WAS PLACED ON 6/11/96 IN THE LEFT SUBCLAVIAN AREA OF THE PT. THE PHYSICIAN REMOVED THE CATHETER DUE TO MALFUNCTION. THE PHYSICIAN AND RADIOLOGIST CONCURRED THAT THE CATHETER FROM THE RIB AND THE CLAVICLE BONES.
THE SWITCH EMITTED SPARKS. INSPECTION REVEALED A BREAK IN THE LINE CORD AT THE STRAIN RELIEF. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS ADDED A CAUTION TO THE LABELING TO NOT FLEX THE POWER SUPPLY CORD NEDDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY OF OCCURRENCE IS ADDRESSED IN LABELING. FREQUENCY OF OCCURRENCE IS NOT GREATER THAN LABELED. SEVERITY OF OCCURRENCE IS ADDRESSED IN LABELING. SEVERITY OF OCCURRENCE IS NOT GREATER THAN LABELED. ONE PERSON AFFECTED.
THE SWITCH REMAINED IN THE "ON" POSITION. THE UNIT HAS NOT BEEN RETURNED TO CO TO BE INSPECTED AND MAY NOT BE. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY OF OCCURRENCE IS NOT ADDRESSED IN LABELING. FREQUENCY OF OCCURRENCE IS GREATER THAN USUAL. SEVERITY OF OCCURRENCE IS ADDRESSED IN LABELING. SEVERITY OF OCCURRENCE IS NOT GREATER THAN LABELED. ONE PERSON AFFECTED.
PT WAS HAVING SURGERY FOR FRACTURE OF RIGHT HIP. AT THE TIME THE CEMENT WAS INSERTED, THE PT'S BLOOD PRESSURE DROPPED AND DEATH OCCURRED.
PT HAD INFECTION WHICH REQUIRED REPLACEMENT.
THE ACCOUNT REPORTED THAT THE SCISSORS TIP BROKE OFF DURING A FACE LIFT OPERATION. THE ACCOUNT DOES NOT KNOW WHICH PHYSICIAN WAS INVOLVED, OR WHEN THE EVENT HAPPENED. ACCORDING TO THE ACCOUNT, THERE WAS NO PT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT.
HAS OR IS EVENT OCCURRING MORE FREQUENTLY, THAN STATED IN LABELING: U, USUAL FOR DEVICE: U, OR HAS OR IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING: U, USUAL FOR DEVICE: U.
EXPLANT OF PERMANENT PACEMAKER AND INSERTION OF DUAL CHAMBER PACEMAKER.
PT HAD AN INFECTION AND IT DAMAGED THE PRODUCT REQUIRING REPLACEMENT.
DURING A ROUTINE CHECK A CLINICIAN OBSERVED LEAKING AT THE IV SITE, SHE ATTEMPTED TO FLUSH WITHOUT SUCCESS. SHE CONTACTED THE IV NURSE WHO REMOVED THE DRESSING AND FOUND THAT A PORTION OF THE CATHETER WAS MISSING. THE IV NURSE MANAGER REPORTED THAT "APPROX ONE INCH OF THE CATHETER MATERIAL WAS SHEARED OFF". X-RAYS WERE TAKEN OF THE ARM AND CHEST. THE SEVERED CATHETER FRAGMENT WAS NOT FOUND. THE PT, AN 83 Y/O FEMALE IN A CONFUSED MENTAL STATE, SUFFERED NO ADVERSE EFFECTS FROM THE INCIDENT. THE HOSP WILL NOT RELEASE THE CATHETER FOR ANALYSIS.
510(K) K843033. NO FOLLOW-UP REPORT WILL BE FILED AT THIS TIME, ALTHOUGH CO RESERVES THE RIGHT TO DO SO AT A FUTURE DATE. REPORTED EVENT MAY HAVE OCCURRED MORE FREQUENTLY OR WITH GREATER SEVERITY THAN USUAL OR THAN STATED IN THE LABELING: NO.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT REMOVAL DUE TO UF (ULTRAFILTRATION) PUMP THERMAL FUSE, THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY OF THE SPECIFIC S/N MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION FOR THE TIME PERIOD SEARCHED. A SECONDARY SEARCH OF THE DTF HISTORY OF THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE 1ST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH SUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAF#960016. CUSTOMER CONTACTED:Y. SALES/SVC CONTACTED:Y. TRAINING REQUIRED?Y. REPORT ATTACHED? Y.
INFANT RE-INTUBATED. UNABLE TO AUSCULTATE BREATH SOUND. SAO2 100%. TUBE PULLED. TIP OF STYLET LODGED IN TUBE. REINTUBATED WITH NEW TUBE. INFANT'S SA02 100%. TIP OF STYLET CAME OFF OF WIRE AND LODGED IN ETT TUBE.
AICD GENERATOR WAS NOT SENSING CORRECTLY AND WAS FIRING INAPPROPRIATELY. ON 7/26/96 THE MALFUNCTIONING GENERATOR WAS REMOVED AND A NEW AICD GENERATOR IMPLANTED.
PT UNDERWENT SUBOCCIPITAL CRANIOTOMY, C-1 LAMINECTOMY, AND DURAL GRAFT IN 6/96. IN 7/96, THE PT WAS READMITTED WITH A DIAGNOSIS OF RULE OUT ACSEPTIC MENINGITIS. CULTURE RESULTS WERE POSITIVE FOR ASPERGILLUS FUMIGATUS: THE PT DEVELOPED LIFE THREATENING COMPLICATIONS OF THIS INFECTION. DESPITE MAXIMUM MEDICAL AND SURGICAL THERAPIES, THE PT DIED ON 8/24/96.
PT WAS SCHEDULED FOR BILATERAL BREAST CAPSULECTOMY WITH PROSTHETIC REPLACEMENT. AFTER BOTH IMPLANTS WERE REMOVED, DR DISCOVERED THAT THEY WERE DIFFERENT SIZES. BOTH IMPLANTS WERE LABELED AS 360CC IMPLANTS, HOWEVER, THE RIGHT IMPLANT CIRCUMFERENCE WAS SMALLER THAN THE LEFT. REPLACED RIGHT IMPLANT WITH ANOTHER 360CC IMPLANT.
AT END OF RF UNSUCCESSFUL ABLATION, UPON REMOVAL OF RIGHT FEMORAL VENOUS SHEATH, THE SHEATH TORE. THE DISTAL END OF THE SHEATH REMAINED IN THE FEMORAL VEIN AND MIGRATED TOWARD THE ILIAC VEIN. ATTEMPTED TO RETRIEVE BY FEMORAL CUT DOWN BUT IT HAD MIGRATED TO COMMON ILIAC VEIN. BROKEN PIECE RETRIEVED UNDER FLUOROSCOPY WITH SHARING DEVICE. BLOOD LOSS 400CC. SCAR TISSUE FELT WITH INSERTION BUT NOT DIFFICULT INSERTION. 3500 UNITS WITH   HEPARIN GIVEN FOR PROCEDURE (ABLATION). SCAR TISSUE FELT TO BE FROM PREVIOUS ANGIO.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNK. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS-MODEL/CATALOG # 3912HL/3912HL. LOT NUMBER 953604.
BLUE INTRODUCER DETACHED FROM PEG TUBE DURING INSERTION WITH NORMAL TRACTION. GRASPED END OF PEG (LEFT IN ABD.) THE HEMOSTAT PER PHYSICIAN AND PULLED TO CORRECT POSITION.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT REMOVAL DUE TO UF (ULTRAFILTRATION) PUMP THERMAL FUSE. PT UNDERWENT AN UNSCHEDULED TREATMENT TO REMOVE THE WEIGHT.
A REVIEW OF THE DTF HISTORY DOES NOT APPLY, A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC S/N MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION FOR THE TIME PERIOD SEARCHED. A SECONDARY SEARCH OF THE DTF HISOTRY FOR THIS PRODUCT IS NOT POSSIBLE. ID OF PRODUCT EQUIPMENT (N/A IF NOT USED): DMM HJ4399. TEST PROCEDURE FOLLOWED: QARA-146 SECT. 9.0 REVISION: E.) THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSED THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE MAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19 VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR#960016. CUSTOMER CONTACTED: Y. SALES/SVC CONTACTED BY INVESTIGATOR? Y. TRAINING REQUIRED? Y. REPORT ATTACHED? Y.
BLUE INTRODUCER DETACHED FROM PEG TUBE DURING INSERTION WITH NORMAL TRACTION, LEAVING END OF PEG IN ABDOMEN. PEG RETRIEVED FROM OPPOSITE END THROUGH MOUTH.
PT'S LEFT BREAST IMPLANT DEFLATED SPONTANEOUSLY ON 6/14/96. HAD TO RETURN TO OR APPROX. 2 YRS LATER ON 6/20/96 FOR LEFT BREAST PROSTHESIS REPLACEMENT.
43 YR OLD FEMLAE UNDERWENT A LEFT BREAST RECONSTRUCTION WITH TISSUE EXPANDER ON 4/23/96. WITHIN THE FIRST MONTH OF THE POST-OPERATIVE PERIOD IT WAS NOTED THAT THE EXPANDER APPEARED SIGNIFICANTLY SMALLER WITH A PROMINENT FOLD MEDIALLY, CREATING IRRITATION OF OVERLYING SKIN. ATTEMPTED EXPANSION WAS MADE WHICH MADE FOLD MORE PROMINENT. TAKEN BACK TO SURGERY AND LEAK WAS FOUND.
PT IN FOR PTCA WITH STENT PLACEMENT. STENT BECAME DISLODGED WHILE IN THE RCA. STENT REMOVED FROM RCA AND REMAINS IN AORTA.
TROCAR BROKE IN TWO PIECES DURING REMOVAL FROM PT'S ABDOMEN. MFR'S REPRESENTATIVE PRESENT IN OR.
A BLOOD STAIN WAS FOUND IN 7 NEWLY OPENED NEEDLES PRIOR TO USE BY THE CLINICAL LABORATORY TECHINICIAN ON TWO SEPARATE DAYS. A REDDISH STAIN WAS IDENTIFIED ON THE SLEEVES OF THE NEEDLE PORTION THAT IS USED TO PENETRATE THE RUBBER CAP OF THE BLOOD COLLECTION TUBE. A SAMPLE OF THIS MATERIAL WAS PREPARED ON A NORMAL SALINE WETMOUNT SLIDE AND RED BLOOD CELLS WERE IDENTIFIED. ALL NEEDLES FROM THIS MFR WERE IMMEDIATELY PULLED FROM THE LAB AND WILL BE STORED AS A BIOHAZARDOUS WASTE UNTIL FURTHER NOTICE.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INSUFFICIENT WEIGHT REMOVAL; TARGET WEIGHT REMOVAL WAS 2.8KG, ACTUAL WEIGHT REMOVAL WAS 0.4KG. THERE WAS NO PT INJURY OR MED INTERVENTION.
PT NOTED TO BE IN ASYSTOLE DESPITE "TVC" ATTACHED TO PULSE GENERATOR.  GIVEN ATROPINE IV PUSH. RETURNED TO REGULAR SINUS RHYTHM. NO FURTHER PT INJURY. PT IS DOING WELL.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNK. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
TWO REPORTED INCIDENTS WITH SYSTEM PRINTERS GIVING WRONG INFO. PRINT HEADER SHOWS PT IN ROOM R4207 AND PRINT EDGE SHOWS ROOM R4202. PRINT ARRHYTHMIA CLASS REQUESTED AND PRINTER PRINTED TEST PATTERN. MFR'S TECHNICAL SUPPORT SAYS THESE ARE KNOWN PROBLEMS; FIELD SVC SAYS THEY ARE NOT.
PT RECEIVED THREE ELECTROSHOCK TREATMENTS AT THE STATE HOSP IN 1963. AFTERWARDS WAS COMPLETELY DISORIENTED FOR A PERIOD OF SEVERAL MONTHS. WAS FORCED TO EDUCATE SELF ALL OVER AGAIN. HAD TO LEARN TO MULTIPLY NUMBERS, TO ADD, TO USE AN ADULT VOCABULARY AGAIN. HAD TO LEARN AGAIN HOW TO DRIVE A CAR. SUFFERS TO THIS DAY FROM PERMANENT, IRREVOCABLE MEMORY LOSS.
PHONE CALL FROM PT; CAP LEAKING. PT WAS VISITED. FOUND CAP LEAKING WHERE WHITE PART OF CAP MEETS CLEAR PART OF CAP. CAP CHANGED.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUANTITY AND INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
SPOKE WITH PT'S MOM. STATES CAP LEAKING. ABLE TO CHANGE CAP.
THE STAFF HAD WOUND THE HOIST UP TO THE TOP TO TAKE A RESIDENT OUT OF THE BATH. THE HOIST SUDDENLY DROPPED WITH THE RESIDENT ON IT. THEY WERE SHAKEN BUT NOT INJURED. TWO OR MORE PERSONS INVOLVED.
UPON INSPECTION OF THE HOIST IT WAS FOUND THAT BOTH THE TOP AND CENTER SCREWS HAD SHEARED. THE SCREWS THAT HAD SHEARED WERE CHROME, THESE WERE REPLACED BY BLACK SCREWS ACCORDING TO TIB'S CA001 & CA002. THIS INCIDENT WAS CAUSED BY A MAINTENANCE ERROR ON THE PART OF ARJO AS ALL CHROME SCREWS SHOULD HAVE BEEN REPLACED WITH BLACK ONES. NEW SCREWS AND GASKET HAVE BEEN FITTED TO THE HOIST.
PHONE CALL FROM PT'S DAUGHTER. CAP LEAKING. DAUGHTER ABLE TO CHANGE CAP, HOWEVER, NURSING VISIT NEEDED DUE TO DRESSING BEING WET.
THE CATHETER TIP WAS FOUND TO BE BENT DURING A ROUTINE CHEST X-RAY. THE PUMP DID NOT ALARM. THE IAB WAS REMOVED AND THERE WERE NO PT COMPLICATIONS.
INSTRUMENT BROKE WHILE IMPACTING INSERT CAUSING A SURGICAL DELAY.
PT ADMITTED 8/9/96 ON MED/SURG UNIT ON TELEMETRY. RHYTHM STRIPS POSTED ON ADMISSION AT 12:52, 14:24, 19:54, 23:47, ON 8/9/96 00:47. PT FOUND IN RESPIRATORY ARREST BY NURSE. CENTRAL MONITOR IN ICU REVEALED NO STORED OR AUDIBLE ALARMS AFTER 14:24. PT RHYTHM SHOWED V-FIB, THOUGH MONITOR DID NOT AUTOMATICALLY PRINT STRIP OR STORE ALARMS. ICU STAFF REPORTED DID NOT RECEIVED ALARM ON MONITOR. CO REPRESENTATIVE REVIEWED ALL EQUIPMENT. ALL EQUIPMENT CHECKED OUT WITH NO PROBLEMS IDENTIFIED WITH ARRHYTHMIA MONITOR OR TRANSMITTER.
DURING ROUTINE TESTING OF THE DEFIBRILLATOR, IT WAS NOTED THAT THERE WAS NO SIGNAL ON EITHER THE MONITOR OR THE CHART RECORDER. THERE WAS NO PT INVOLVED.
BLOCK B4 INDICATED A REPORT DATE OF 8/16/66. IT SHOULD HAVE BEEN 8/16/96.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVEN IS OCCURRRING AT A AFREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT FROM TEMPORARY PROSTHESIS AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL LOADING OF IMPLANT AS CAUSE FOR FAILURE. PT IS A BRUXER AND HAS DIMINISHED ORAL HYGENE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVCERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNK. PT MAY BE A BRUXER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURING AT A FREQUENCY AND SEVERITY THAT US CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
CATHETER WAS INSERTED IN LEFT AC (SAPHENOUS VEIN). DURING INSERTION THE LOCK ENGAGED AND WOULD NOT ALLOW THE CATHETER TO ADVANCE. THE COVER OVER THE CATHETER SEPARATED AND EXPOSED THE STERILE CATHETER. THE LINE WAS TAPED IN PLACE WITH GOOD BLOOD RETURN AT THREE (3") INCHES. THE IV INFILTRATED AND WAS DC'D. IT WAS THEN FOUND THAT THE LOCK HAD FAILED AND THE CATHETER HAD BEEN PULLED OUT. PT WAS IN DKA AND REQUIRED NA BICARB DRIP AND IV POTASSIUM CHLORIDE. PT WAS IN CRITICAL CONDITION AND WITH INABILITY TO LOCATE ANOTHER APPROPRIATE IV SITE, PHYSICIAN TRANSFERRED PT TO ANOTHER ACUTE CARE FACILITY.
THE PHYSICIAN WAS ATTEMPTING TO EMBOLIZE AN AVM IN THE POSTERIOR CEREBRAL ARTERY WITH A FLOW DIRECTED MICRO CATHETER. ANOTHER CATHETER WAS FIRST INSERTED THROUGH A GUIDING CATHETER AND DID NOT ADEQUATELY REACH THE PATHOLOGY. THE OTHER CATHETER THEN BECAME LODGED IN THE ARTERY AND REQUIRED 20 MINUTES OF GENTLE TENSION TO REMOVE THE CATHETER FROM THE POSTERIOR CIRCULATION. THE FLOW DIRECTED MICRO CATHETER WAS THEN FLOATED TO THE AVM. ALTHOUGH THE CATHETER REACHED THE AVM, THE PHYSICIAN DID NOT FEEL THAT IT WAS POSITIONED CORRECTLY FOR OPTIMUM EMBOLIZATION. HE THEN ATTEMPTED TO PULL THE DEVICE BACK WHEN IT GOT STUCK IN THE CEREBRAL VESSELS. THE PHYSICIAN THEN INSERTED ANOTHER CO'S WIRE INTO THE DEVICE TO PROVIDE MORE COLUMN STRENGTH TO THE SYSTEM. THE DEVICE STILL COULD NOT BE PULLED OUT OF THE VESSEL. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE AND PULLED ON THE CATHETER UNTIL THE 45 CM DISTAL SECTION STRETCHED TO 100 CM. HE TRIED THE DISTAL SECTION TO THE SHEATH IN THE GROIN, HEPARINIZED THE PT AND THE LEFT THE CATHETER IN THE VESSELS OVERNIGHT. THE NEXT MORNING THE CATHETER HAD RELAXED AND RECOILED TO THE MESENTERIC ARTERY WHERE IT COULD BE REMOVED FROM THE PT. THERE WAS NO EVIDENCE OF PT INJURY OR ADVERSE EFFECT.
THE CATHETER WAS EXAMINED UNDER 100X MAGNIFICATION. THE MATERIAL OF THE DISTAL SECTION WAS OBSERVED AS HAVING STRIATIONS CONSISTENT WITH STRETCHING AND THERE WERE SEVERAL AREAS ALONG THE SHAFT WHICH WERE PINCHED OFF AND KINKED. THE DISTAL SECTION HAD BEEN ELONGATED FROM ITS ORIGINAL LENGTH OF 45 CM TO 60 CM IN LENGTH. THERE WAS NO EVIDENCE OF RUPTURE, SEPARATION OF OTHER DEFECTS FOUND IN THE CATHETER. THE HUB AND STRAIN RELIEF HAD BEEN REMOVED AT THE PROXIMAL END OF THE CATHETER AND THE SHAFT WAS TIED OFF IN A KNOT BY THE PHYSICIAN. EVENT HAS NOT OCCURRED WITH GREATER FREQUENCY NOR WITH GREATER SEVERITY THAN IS STATED IN THE LABELING FOR THIS DEVICE.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT FROM TEMPORARY PROSTHESIS AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS - MODEL/CATALOG # 4512HL/4512HL. LOT NUMBER 952473.
DR EXPLANTED THE PENILE PROSTHESIS DUE TO FLUID LOSS.
THE MALFUNCTION OF PHACO HANDPIECE AND/OR MACHINE CAUSED TISSUE TO BURN BECAUSE OF INADEQUATE COOLING. IT IS TOO SOON TO TELL IF THERE WILL BE PERMANENT DAMAGE TO THE PT. TO DATE SHE IS HEALING WELL. THE CO REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE TO SUPERVISE THE PHYSICIAN'S USE AS THE EQUIPMENT WAS ON TRIAL AND EVALUATION.
AFTER COMPLETION OF ENDOSCOPY PROCEDURE AND REMOVAL OF SCOPE, PT WAS SUCTIONED ORALLY WITH A SALIVA EJECTOR. UPON REMOVAL OF THE SALIVA EJECTOR FROM THE MOUTH, IT WAS NOTED THAT THE BLUE TOP OF THE SALIVA EJECTOR WAS MISSING. STAFF UNABLE TO LOCATE BLUE TIP DIGITALLY IN PT ORAL CAVITY. PHYSICIAN PRESENT AND RE-SEDATED PT AND PT RE-ENDOSCOPED AND BLUE TIP NOTED IN PROXIMAL ESOPHAGUS. PHYSICIAN ADVANCED BLUE TIP INTO STOMACH WHERE IT WAS RETRIEVED WITH THE ROTH NET.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNK. THIS FILE IS CLOSED. THE REPORTER EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT HAD BILATERAL SILICONE BREAST IMPLANTS IN 1976. BREAST IMPLANTS WERE REMOVED ON 6/28/96 BECAUSE OF LEAKING. CONTACTED PHYSICIANS OFFICE WHICH DID NOT KNOW ANY SPECIFICS ABOUT TYPE OF IMPLANTS ONLY THE YEAR THEY WERE PUT IN; 1976.
PT USING O2 CONSERVING DEVICE WITH OXYGEN CYLINDER. UPON GETTING OUT OF THE CAR HEARD A LOUD LEAKING NOISE, THEN SAW SOME SMOKE, THEN EVERYTHING WAS ON FIRE.
THE SWITCH REMAINED IN THE "ON" POSITION. CO'S INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROX 1967 TO 6/21/90, CO USED AN UNDERWRITER'S LAB LISTED SWITCH MFG BY A REPUTABLE FIRM. THE SWITCH WAS MOMENTARY TYPE SWITCH WITH A SPRING LOADED LEVER WHICH REQUIRED BEING HELD IN THE "ON" POSITION TO MAKE CONTACT. SOMETIMES A USER WOULD NOT FULLY ENGAGE THE LEVER, ALLOWING THE CONTACTS TO REMAIN SLIGHTLY OPEN WHICH COULD INDUCE ARCING. WHEN CONSISTENTLY HELD IN THIS WAY, CARBON BUILD-UP FROM THE ARCING COULD REACH OPPOSITE POLES CAUSING THE SWITCH TO EMIT A SMALL AMOUNT OF SMOKE. CO'S FIRST SOLUTION WAS TO CHANGE THE CONTACT MATERIAL AND THE BODY OF THE SWITCH. THIS REDUCED THE ARCING OF THE CONTACT AND THE CARBON TRACKING OF THE SWITCH BODY. ALTHOUGH THE SITUATION WAS IMPROVED, THE OCCASIONAL RELEASE OF A PUFF OF SMOKE WAS POSSIBLE. ON 6/21/90, CO BEGAN USING A SNAP ACTION SWITCH WHICH DOES NOT ALLOW THE CONTACTS TO BE HELD IN A SLIGHTLY OPEN POSITION. THIS EVENT IS NOT REPORTABLE UNDER 21CFR803 BECAUSE SIMILAR EVENTS WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO BE COMPLIANT WITH REGULATORY LETTER 90-DT-12. REMEDIAL ACTION HAS BEEN ACCOMPLISHED.
FREQUENCY OF OCCURRENCE IS NOT ADRRESSED IN LABELING. FREQENCY OF OCCURRENCE IS GREATER THAN USUAL. SEVERITY OF OCCURRENCE IS ADDRESSED IN LABELING. SEVERITY OF OCCURRENCE IS NOT GREATER THAN LABELED. NUMBER OF PEOPLE AFFECTED IS UNKNOWN.
ON 8/21/96-LEFT TOTAL HIP REPLACEMENT USING PROSTHESIS, #48 ACETABULUM #15 FEMORAL STEM, SHORT NECK. 8/8/96-POST LEFT HIP REPLACEMENT WITH FAILURE OF ACETABULUM LINER. FAILED IMPLANT REMOVED AND REPLACED.
THE SWITCH EMITTED FIRE. THE UNIT HAS NOT BEEN RETURNED TO CO FOR INSPECTION AND MAY NOT BE. NO DEATHS OR INJURIES HAVE BEEN REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY OF OCCURRENCE OF THIS EVENT IS ADDRESSED IN LABELING. FREQUENCY IS NOT GREATER THAN LABELED. SEVERITY OF THIS EVENT IS ADDRESSED IN LABELING. SEVERITY IS NOT GREATER THAN LABELED. NUMBER OF PERSONS AFFECTED IS UNKNOWN.
THIS PT HAD TWO SURGERIES, FIVE TO SIX YRS AGO FOR C 1-2 INSTABILITY AND 1-2 SUBLUXATION. INITIAL SURGERY WAS IN 1990 AND THEN IN 11/91 HAD REPEAT C 1/2 GALLIE TYPE FUSION. (WIRES WERE BROKEN). NOW THE PT WAS ADMITTED TO HOSP 8/8/96 FOR SURGERY-C 1-2 TRANSARTICULAR SCREWS WITH C 1-2 FUSION. HE HAD HAD POSTERIOR NECK PAIN FOR SEVERAL MONTHS.                                                                              PREVIOUS GALLIE
THE CORD EMITTED SPARKS. CO'S INSPECTION REVEALED THE ELECTRICAL CORD WAS BROKEN AT THE STRAIN RELIEF. NO DEATHS OR INJURIES WERE REPORTED. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS ADDED A CAUTION TO THE LABELING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY OF OCCURRENCE IS ADDRESSED IN LABELING. FREQUENCY OF OCCURRENCE IS NOT GREATER THAN LABELED. SEVERITY OF OCCURRENCE IS ADDRESSED IN LABELING. SEVERITY OF OCCURRENCE IS NOT GREATER THAN LABELED. NUMBER OF PERSONS AFFECTED IS 1.
STUDENT NURSE SQUEEZED RESERVOIR TOO HARD SPLASHING BLOOD AND FLUID IN HER FACE AND EYES. THIS IS CONTRARY TO PACKAGE LABEL DIRECTIONS.
SECTION A THROUGH H COMPLETED BY MFR. STUDENT NURSE SQUEEZED RESERVOIR TOO HARD SPLASHING BLOOD AND FLUID IN HER FACE AND EYES. THIS IS CONTRARY TO PACKAGE LABEL DIRECTIONS.
APPROX 4 HRS AFTER INITIATION OF DIALYSIS TREATMENT PT HAD VENOUS NEEDLE DISLODGE. BLOOD WAS NOTED ON FLOOR. BLOOD PUMP STOPPED AND LINES WERE CLAMPED. PT WAS SLEEPING AT THE TIME AND WAS BELIEVED TO HAVE JERKED HIS ARM WHILE SLEEPING. PT AROUSABLE THEN LOST CONSCIOUSNESS FOR SEVERAL SECONDS. PT RESPONDED TO SALINE BOLUS AND WAS VERBALLY COMMUNICATIVE AFTER THE EVENT. PT TRANSFERRED TO EMERGENCY ROOM AFTER EVENT, SEEN AND RELEASED. BLOOD LOSS WAS ESTIMATED AT 500 CC. DIALYSIS SYSTEM DID NOT ALARM LOW VENOUS PRESSURE AT TIME OF EVENT. HOWEVER, THE VENOUS PRESSURE MONITORING TRANSDUCER PROTECTOR WAS NOTED TO BE BLOODY AT TIME OF EVENT AND MAY NOT HAVE BEEN MONITORING PROPERLY. FACILITY HAS BEEN HAVING PROBLEMS WITH TRANSDUCERS BACKING UP. TUBING PULLED FROM USE AND EVALUATED BY TECHNICAL DEPARTMENT. ALL ALARMS FUNCTIONING PROPERLY AND CALIBRATIONS VERIFIED. MDR'S BEING DONE ON TRANSDUCER PROTECTOR AND VENOUS BLOODLINE SINCE IT IS UNCLEAR WHICH IS THE SOURCE OF THE PROBLEM. PT RETURNED TO THE DIALYSIS UNIT 8/8/96 AND DIALYZED WITHOUT DIFFICULTY.
STENT CAME OFF OF DELIVERY SYSTEM DURING DEPLOYMENT ATTEMPT AND LODGED IN MID RCA. MD DID NOT ATTEMPT TO RETRIEVE OR DISPLACE STENT. VESSEL IMPLANTED IN RCA.
INVESTIGATION CONDUCTED. DR CITES BONE QUANTITY INSUFFICIENT AS CAUSE FOR FAILURE. PT HAS POOR ORAL HYGIENE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT HAVING SURGERY FOR FRACTURE OF RIGHT HIP. AT THE TIME THE CEMENT WAS INSERTED, THE PT'S BLOOD PRESSURE DROPPED AND DEATH OCCURRED.
INVESTIGATION CONDUCTED. DR CITES BONE QUANTITY INSUFFICIENT AND INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS -MODEL/CATALOG # UNK/UNK. LOT NUMBER UNK.
DURING A DIALYSIS TREATMENT, THE FACILITY HAD DIFFICULTIES WITH THE ARTERIAL/VENOUS PRESSURES. A BROKEN BLOOD PUMP ROTOR SPRING WAS FOUND. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE FACILITY FOUND A BROKEN BLOOD PUMP ROTOR SPRING AND REPLACED IT WITH A NEW ONE. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTED THAT THE SPRING BROKE IN FOUR PIECES.
DURING SURGERY WHICH UTILIZED A DEVICE WITH TWO OTHER ELECTROCAUTERY UNITS, THE PT RECEIVED RF (RADIO FREQUENCY) BURNS AT THE SITE OF THE ELECTRODES. IT IS NOT KNOWN AT THIS TIME IF THE DEVICE CONTRIBUTED TO THE EVENT. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.
DURING A CALL INVOLVING AN UNCONSCIOUS 92 YR OLD MALE IN CARDIAC ARREST, TEH CUSTOMER REPORTEDLY COULD NOT PEEL THE PADS APART. THE PT WAS PRONOUNCED AT HOME.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY INSUFFICIENT AND INFECTION AS CAUSE FOR FAILURES. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS - MODEL/CATALOG # 2610H/2610H LOT NUMBER 943553.
INVESTIGATION CONDUCTED. DR CITES BONE QUANTITY INSUFFICIENT AND INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR TYHIS TYPE OF DEVICE.
CHAIR WITH RESIDENT WAS NOT LOCKED INTO PLACE ON CARRIER. CHAIR SLID OFF CARRIER CAUSING BOTH CHAIR AND RESIDENT TO FALL TO FLOOR. RESIDENT SUFFERED 1/2" CUT ON ELBOW.
CHAIR WITH RESIDENT WAS NOT LOCKED INTO PLACE ON CARRIER. CHAIR SLID OFF CARRIER CAUSING BOTH CHAIR AND RESIDENT TO FALL TO FLOOR. COMPANY REPRESENTATION CHECKED OUT CARRIER AND IT WAS FUNCTIONING PROPERLY.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY INSUFFICIENT AND INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY INSUFFICIENT AND INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPROTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
STAFF MEMBERS WERE ATTEMPTING TO MONITOR A PT (AGE AND GENDER UNKNOWN). THEY INDICATED THAT THE UNIT WAS NOT ABLE TO MONITOR THE PT IN LEAD II. THE STAFF OBTAINED ANOTHER UNIT (MFR UNKNOWN) AND CONTINUED MONITORING THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT.
INVESTIGATION CONDUCTED. DR CITES BONE QUANTITY INSUFFICIENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPROTED EVENT IS OCCURRING AT A FREEQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLNATS - MODEL/CATALOG # 2918TPS/2918TPS. LOT NUMBER 951739.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNK. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUSAL FOR THIS TYPE OF DEVICE.
THE BALLOON BURST IN SITU AFTER A SHORT PERIOD OF USE. THE CATHETER WAS REMOVED WITHOUT ANY COMPLICATIONS.
THE SAMPLE WAS RETURNED FOR EVALUATION. IT WAS NOT POSSIBLE TO EVALUATE THE BALLOON ON THE RETURNED CATHETER BECAUSE 3.5 CM OF THE CATHETER HAD BEEN CUT OFF BY THE USER.
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
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS - MODEL/CATALOG # 2214H.2/2214H.2, 2214H.2/2214H.2. LOT NUMBER 941985, 941985.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT IS A SMOKER AND CONSUMES ALCOHOL. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS - MODEL/CATALOG # 2910HL/2910HL. LOT NUMBER 951436.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNK. THIS FIEL IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
A NEW NUCLEAR TECH REMOVED THE COLLIMATOR FROM THE DETECTOR FACE WITH THE SERVER. TECH BARELY INSERTED THE COLLIMATOR INTO THE COLLIMATOR RACK WHEN THE TOP OF THE COLLIMATOR FELL TO THE LEFT OF THE SERVER. TECH CAUGHT THE COLLIMATOR WITH HIS HANDS AND LAID IT ONTO THE BASE OF THE COLLIMATOR SERVER. ANOTHER PERSON ENTERED THE ROOM AND HELPED TECH LIFT THE COLLIMATOR ONTO THE COLLIMATOR RACK.
THE INVESTIGATION OF THIS INCIDENT FOUND THAT THE PROCEDURE FOR COLLIMATOR CHANGING AS DESCRIBED IN THE OPERATORS MANUAL (98-090001) WAS NOT PROPERLY FOLLOWED.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY INSUFFICIENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY USUAL FOR THIS TYPE OF DEVICE.
THE MONITOR SET AN APNEA LED WITH NO AUDIBLE ALARM. CO TESTED THE MONITOR AND WAS UNABLE TO REPRODUCE THE MALFUNCTION. THE MONITOR AUDIBLE ALARMS PERFORMED EXACTLY AS INTENDED PER SPECIFICATION. BOTH THE VISUAL AND AUDIBLE ALARMS ARE DESIGNED TO ACTIVATE WHEN THE RESPIRATION RATE FALLS OUTSIDE THE SETTING PRESCRIBED BY THE PHYSICIAN. THE AUDIBLE ALARM STOPS SOUNDING WHEN THE RESPIRATION RATE RETURNS TO NORMAL. THE VISUAL ALARM IS LATCHED, WHICH MEANS THAT IS WILL NOT STOP FLASHING WHEN THE BABY'S RESPIRATION RATE RETURNS TO NORMAL. THE VISUAL ALARM CAN ONLY BE RESET MANUALLY (BY DEPRESSING THE RESET BUTTON). CO SUSPECTS THAT AN AUDIBLE ALARM DID SOUND BUT THAT THE CAREGIVER DIDN'T HEAR IT BECAUSE IT CORRECTED ITSELF SO QUICKLY. IF THE APNEA LIMIT SETTING WAS 15 BEATS PER MINUTE (BPM), FOR EXAMPLE, THE MONITOR IS DESIGNED TO RESPOND BY SOUNDING THE AUDIBLE ALARM FOR 1 SECOND AND THEN RESETTING WHILE THE VISUAL ALARM (A FLASHING LED) CONTINUES TO FLASH. IF THE CAREGIVER, DOESN'T HEAR THE ALARM, WHICH IS REASONABLE GIVEN ITS SHORT DURATION, THE CAREGIVER MIGHT CONCLUDE THAT NO AUDIBLE ALARM SOUNDED EVEN THOUGH A VISUAL ALARM WAS ACTIVATED. CO HAS NEVER BEEN ABLE TO REPRODUCE THE FAILURE TO ACTIVATE AN AUDIBLE ALARM FOR AN EVENT THAT PRODUCES A VISUAL ALARM. DETAILS OF THE SOFTWARE DESIGN CAUSES CO TO BELIEVE THAT THIS IS NOT POSSIBLE IN A 2000W DEVICE WITH AN OTHERWISE FUNCTIONING ALARM, SUCH AS THE DEVICE IN THIS REPORT.
THE FREQUENCY AND SEVERITY OF THIS TYPE OF OCCURRENCE IS NOT AT A GREATER RATE THAN WOULD BE EXPECTED FOR THIS TYPE OF DEVICE. CO WILL MONITOR THE FREQUENCY OF THIS FAILURE MODE BUT DOESN'T EXPECT ANY FURTHER INVESTIGATION INTO THIS SPECIFIC INCIDENT.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNK. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.  OTHER FAILED IMPLANTS - MODEL/CATALOG # 2214/2214.
THE MONITOR HAD SET AN APNEA LED WITH NO AUDIBLE ALARM. CO TESTED THE MONITOR AND WAS UNABLE TO REPRODUCE THE MALFUNCTION. THE MONITOR AUDIBLE ALARMS PERFORMED EXACTLY AS INTENDED PER SPECIFICATION. BOTH THE VISUAL AND AUDIBLE ALARMS ARE DESIGNED TO ACTIVATE WHEN THE RESPIRATION RATE FALLS OUTSIDE THE SETTINGS PRESCRIBED BY THE PHYSICIAN. THE AUDIBLE ALARM STOPS SOUNDING WHEN THE RESPIRATION RATE RETURNS TO NORMAL. THE VISUAL ALARM IS LATCHED, WHICH MEANS THAT IT WILL NOT STOP FLASHING WHEN THE BABY'S RESPIRATION RATE RETURNS TO NORMAL. THE VISUAL ALARM CAN ONLY BE RESET MANUALLY (BY DEPRESSING THE RESET BUTTON). CO SUSPECTS THAT AN AUDIBLE ALARM DID SOUND BUT THAT THE CAREGIVER DIDN'T HEAR IT BECAUSE IT CORRECTED ITSELF SO QUICKLY. IF THE APNEA LIMIT SETTING WAS 15 BEATS PER MINUTE (BPM), FOR EXAMPLE, THE MONITOR IS DESIGNED TO RESPOND BY SOUNDING THE AUDIBLE ALARM FOR 1 SECOND AND THEN RESETTING WHILE THE VISUAL ALARM (A FLASHING LED) CONTINUES TO FLASH. IF THE CAREGIVER, DOESN'T HEAR THE ALARM, WHICH IS REASONABLE GIVEN ITS SHORT DURATION, THE CAREGIVER MIGHT CONCLUDE THAT NO AUDIBLE ALARM SOUNDED EVEN THOUGH A VISUAL ALARM WAS ACTIVATED. CO HAS NEVER BEEN ABLE TO REPRODUCE THE FAILURE TO ACTIVATE AN AUDIBLE ALARM FOR AN EVENT THAT PRODUCES A VISUAL ALARM. DETAILS OF THE SOFTWARE DESIGN CAUSES CO TO BELIEVE THAT THIS IS NOT POSSIBLE IN A 2000W DEVICE WITH AN OTHERWISE FUNCTIONING ALARM, SUCH AS THE DEVICE IN THIS REPORT.
FREQUENCY AND SEVERITY OF THIS TYPE OF OCCURRENCE IS NOT AT A GREATER RATE THAN WOULD BE EXPECTED FOR THIS TYPE OF DEVICE. CO WILL MONITOR THE FREQUENCY OF THIS FAILURE MODE BUT DOESN'T EXPECT ANY FURTHER INVESTIGATION INTO THIS SPECIFIC INCIDENT.
A MALFUNCTION OCCURRED WHICH CAUSED OR CONTRIBUTED TO A DR BEING INJURED AT HOSP. DURING A PROCEDURE WHEN REMOVING THE SYSTEM AWAY FROM THE TABLE, THE VERTICAL DRIVE OF THE C-ARM SUDDENLY DROPPED APPROX 10 TO 15CM AND HIT A SURGEON'S HEAD. SURGEON IMMEDIATELY REPORTED TO EMERGENCY ROOM FOR EXAM. CO REPS RESPONDED TO REPORT AND ON ARRIVAL FOUND C-ARM OPERATING TO SPECIFICATIONS. CO REPS AND HOSP BIO-MED ENGINEER MADE SEVERAL ATTEMPTS TO DUPLICATE THE REPORTED MALFUNCTION. CO DETERMINED TO REMOVE AND REPLACE THE VERTICAL DRIVE TO PREVENT POSSIBLE FUTURE MALFUNCTIONS. CO HAS OPENED CORRECTIVE ACTION TO INVESTIGATE THIS VERTICAL DRIVE. HOSP REPORTED THAT DR RECEIVED ONLY A MINOR BRUISE WITH NO CUTS, SCRAPES, OR ABRASIONS. HOSP BIO-MED ENGINEER INITIATED A WARNING FILE WITH THE FRENCH MINISTRY OF HEALTH.
ROOT CAUSE: OEC, WAS UNABLE TO DETERMINE THE ROOT CAUSE. THE LIFT SYSTEM WAS TESTED BY RECONSTRUCTING THE CONDITIONS THAT IT WAS IN WHEN THE MALFUNCTION WAS REPORTED. THE SYSTEM WAS TESTED FOR APPROXIMATELY 18 HOURS AND THE REPORTED MALFUNCTION WAS NOT OBSERVED DURING THIS TIME PERIOD. THE UNIT WAS DISASSEMBLED AND EACH COMPONENT PART WAS EXAMINED FOR DEFICIENCIES AND NONE WERE OBSERVED.
LASER FIBER NOTED TO HAVE "FRAYED" SMALL PIECES OF GOLD COATING DURING USE FOR LITHOTRIPSY OF BLADDER CALCULUS. ALL PIECES REMOVED WITH GRASPING FORCEPS.
CUSTOMER REPORTED THE DISTAL 1/4 INCH OF GOLD FIBER BROKE OFF AND SUBDIVIDED INTO 6 FRAGMENTS. THE CUSTOMER RETURNED THE REMAINING PORTION OF THE FIBER FOR EVAL. THE EVAL CONCLUDED THAT THE REMAINING FIBER DID NOT EXHIBIT ANY MFG DEFECTS. THE DISTAL TIP, WHERE THE BREAK OCCURRED EXHIBITED CHARACTERISTICS SIMILAR TO A HIGH STRESS BREAK. WHILE THE CAUSE FOR THE BREAK CANNOT BE DEFINITIVELY DETERMINED, THIS TYPE OF BREAK MAY BE RELATED TO EXCEEDING BEND RADIUS SPECIFICATIONS. THE FRAYING CHARACTERISTICS REFERRED TO BY THE CUSTOMER CO BELIEVES IS REPRESENTATIVE OF LASER ENERGY STRIKING THE BROKEN SEGMENT PRIOR TO DISCONTINUING THE PULSING.
INVESTIGATION CONDUCTED. DR CITES POOR ORAL HYGIENE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS - MODEL/CATLOG # 2210/2210.
NO DATA WAS FOUND FOR THEIR TEST OF RECORD DATABASE. THIS REPORT IS INTENDED TO NOTIFY CUSTOMERS OF INSTANCES WHERE MODIFICATIONS TO RECORDS HAVE BEEN MADE AFTER A COMPONENT HAS BEEN SHIPPED. THIS IS EXECUTED IN A CRON TAB FILE WHICH IS SCHEDULED TO RUN AT A SPECIFIC TIME EACH NIGHT. THE CUSTOMER IS TO INVESTIGATE THE ENTRIES ON THIS REPORT AND EVALUATE FOR POSSIBLE RECALL EFFECTS. THIS SITE IS TO INVESTIGATE THE ENTRIES ON THIS REPORT AND CALLED THIS CO'S ATTENTION. INVESTIGATION OF THE SYSTEM ON SITE AS WELL AS THE SOURCE CODE AT CO REVEALED THAT THE REPORT WAS USING THE SITE'S TRAINING DATABASE FOR THE INFO AND NOT THEIR TEST OF RECORD DATABASE. IT WAS ID THAT THE CUSTOMER HAD BEEN PREPARING STANDING ORDERS IN THEIR TRAINING DATABASE THE NIGHT BEFORE THE REPORT WAS EXECUTED. WHEN A STANDING ORDER IS PREPARED ON A SYSTEM THAT IS CONFIGURED WITH A DATABASE SERVER, THE SYSTEM REGENERATES ALL ENTRIES INTHE CRON TAB FILE WITH THE SAME DATABASE LOGIN AS WAS USED TO PREPARE THE STANDING ORDER. IN THE CASE OF A DATABASE SERVER, THE DATABASE LOGIN STRING CONTAINS THE ORACLE ENVIRONMENT (E.G., TRAINING, VALIDATION, OR TEST OF RECORD) THAT WAS SET WHEN THE STANDING ORDER WAS CREATED. THIS COULD RESULT IN A CRON TAB FILE ENTRY TO BE EXECUTED IN A DATABASE DIFFERENT THAN EXPECTED WHEN A DATABASE SERVER IS BEING USED. CO ENSURED THAT THE REPORT HAD BEEN EXECUTING PROPERLY SINCE THEY BEGAN USING THE SYSTEM AS A TEST OF RECORD SYSTEM. SINCE THE STANDING ORDER OPTION IN THE SITE'S TRAINING AND VALIDATION DATABASES FOR ALL AFFECTED CUSTOMERS (2) TO ENSURE THAT THIS PROBLEM WILL NOT REOCCUR. FURTHER, CO REMOVED ALL NON TEST OF RECORD DATABASE LINKS AND SYNONYMS TO TABLES IN THE TWO SITE'S TEST OF RECORD DATABASE. THIS ENSURES THAT ONLY THE TEST OF RECORD DATABASE CAN BE UPDATED INTO THE CRON TAB FILE.
TUBE WAS INSERTED INADVERTENTLY INTO PT'S RIGHT LUNG RESULTING IN PNEUMOTHORAX. THIS WAS REVEALED ON FOLLOW UP X-RAY ONE HR LATER. NG TUBE REMOVED. PT'S FAMILY REFUSED CHEST TUBE PLACEMENT DUE TO PT'S MANY HISTORICAL AND CONCURRENT MEDICAL DIAGNOSES. PT EXPIRED TWO DAYS AFTER EVENT.
ON 8/28/96, IN TELEPHONE CONVERSATION WITH RISK MGR, SHE REPORTED THAT PT HAD NO SYMPTOMS THAT WOULD INDICATE THE NG TUBE WAS IN THE PT'S LUNG. SHE ALSO REPORTED THAT THE EVENT DID NOT APPEAR TO BE DUE TO A PRODUCT MALFUNCTION, BUT MOST LIKELY USER ERROR. INSTRUCTIONS FOR USE WARNING: "COUGHING MAY INDICATE PASSAGE OF THE TUBE INTO TRACHEA. IF THIS IS SUSPECTED, REMOVE THE TUBE AND REINSERT ONCE THE PT IS COMFORTABLE." "PARTICULAR CARE SHOULD BE TAKEN IF ANY TYPE OF ENDOTRACHEAL DEVICE IS IN PLACE, AS IT MAY TEND TO GUIDE FEEDING TUBE INTO TRACHEA." IS FREQUENCY OF THE OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF THE OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U. INSTRUCTIONS FOR USE WARN OF THE POSSIBILITY OF A NASOGASTRIC FEEDING TUBE BEING INCORRECTLY POSITIONED THROUGH THE TRACHEA. KNOWN STATE-OF-THE-ART WOULD REVEAL THAT IF SUCH A DEVICE IS POSITIONED THROUGH THE TRACHEA, THE POSSIBLITY OF A RESULTING PNEUMOTHORAX IS ELEVATED, ESPECIALLY IF THE FEEDING TUBE HAS A STYLET. SUCH A PNEUMOTHORAX IS TYPICALLY RESOLVED, SUCCESSFULLY, USING A CHEST DRAINAGE TUBE. THE FAMILY OF THIS PT REFUSED SUCH ACTION.
INVESTIGATION CONDUCTED. DR CITES PRE-EXPOSURE OF IMPLANT AS CAUSE FOR FAILURE. PT HAS LISPING TONGUE HABITS. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. PT IS A SMOKER AND CONSUMES ALCOHOL. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
AFTER PERFORMING NORMAL SVC IN THE FIELD, SVC TECH DISCOVERED, DURING TESTING OF THE DEVICE, THAT THE DEFIBRILLATOR FAILED THE DELIVERED ENERGY PORTION OF THE SVC MODULE TEST. THE DEVICE CHARGED TO THE PROPER JOULES BUT DELIVERED ONLY 1 JOULE. THE REPORTED DEVICE FAILURE WAS CALLED IN TO     CUSTOMER SVC DEPT FOR A RETURNED MATERIALS AUTHORIZATION #, AND WAS RETURNED TO SVC DEPT FOR EVAL.
A PT TRANSFER RELAY WAS FOUND TO HAVE FAILED, CAUSING THE DEVICE TO NOT DELIVER THE CHARGE. THE DEFECTIVE RELAY WAS REPLACED. A SECOND RELAY WAS ALSO REPLACED AS A PRECAUTION PER CO POLICY. PROPER OPERATION WAS THEN VERIFIED AFTER REPLACING THE RELAYS.
DURING THE CASE, THE FIBER SHEATH FELT VERY WARM-WHEN THE FIBER WAS REMOVED, THE WHITE PLASTIC COATING APPEARED TO HAVE MELTED AND BROKEN IN ONE AREA. PT SUSTAINED BURN TO LOWER LIP.
PATIENT SUSTAINED A 2CM BURN ON LOWER LIP. NO BURN IN TRACHEA. NO MEDICATIONS OR TREATMENTS ORDERED BY PHYSICIAN. LASERSCOPE FIELD SERVICE PERSONNEL VISITED FACILITY ON 8-1-96. NO ERROR CODES NOTED IN LOG, AND NO PROBLEMS FOUND WITH THE LASER SYSTEM. PASSED AUTO-TEST. PERFORMED PREVENTATIVE MAINTENANCE. ON 8-15-96, LASERSCOPE EVALUATED THE RETURNED FIBER AND FOUND THE FIBER TIP BURNED. HOWEVER, ALL FUNCTIONAL TESTS PASSED. FURTHERMORE, THE DISTAL END CLEAVED AND STRIPPED NORMALITY. FIBER WAS USED IN 100% OXYGEN DURING BRONCHOSOPY. THE OXYGEN SATURATION AIDED IN THE FIBER BURNING. USE OF OXYGEN IS WARNED AGAINST IN PRODUCT LABELING.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT FROM TEMPORARY PROSTHESIS AS CAUSE FOR FAILURE. PT IS A SMOKER AND CONSUMES ALCOHOL. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS - MODEL/CATALOG # 2208/220/. LOT NUMBER UNK.
INTRAOCULAR LENS WAS IMPLANTED WITHOUT INCIDENCE. ONE WEEK LATER IT WAS NOTED BY THE MD TO BE DISCOLORED. AT SECOND VISIT, MD NOTED THE LENS TO REMAIN DISCOLORED. DECISION WAS MADE TO REMOVE THE LENS AND REPLACE.
THE USER WAS DRIVING ON A NORTHBOUND STREET. A STREET SWEEPER WAS IN THE NORTHBOUND LANE DRIVING IN REVERSE GOING SOUTH. THE DRIVER OF THE STREET SWEEPER DID NOT SEE THE SCOOTER AND HIT THE RIDER CAUSING HER DEATH. POLICE ARE INVESTIGATING WHY THE SWEEPER DRIVER WAS BACKING UP GOING THE WRONG WAY ON THE STREET.
THE DEVICE DID NOT CONTRIBUTE TO THE INCIDENT AND IS NOT AVAILABLE FOR EVAL. THE FREQUENCY OF THE OCCURRENCE IS A ONE TIME ISOLATED OCCURRENCE. THE SEVERITY OF THE OCCURRENCE IS GREATER THAN USUAL. THE SCOOTER'S OPERATORS MANUAL CAUTIONS USERS THAT DRIVING IN STREETS CAN BE DANGEROUS AS THEY CAN BE STRUCK BY VEHICLES.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT IS A SMOKER AND CONSUMES ALCOHOL. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT ON MSO4 50MG/ML WITH DOSES OF: 60MG/HR CONTINUOUS WITH 10MG EVERY 30 MINUTES (2/HR). ON 8/16/96-PUMP WENT INTO PAUSE MODE, UNKNOWN REASON. A FACILITY EMPLOYEE WENT TO HOME AND RETRAINED PT ON PROCEDURE ON RESTARTING PUMP. PUMP RESTARTED WITHOUT PROBLEMS. ON 8/21/96, FACILITY CALLED THAT THE PUMP WAS ALARMING, PUMP WAS IN PAUSE MODE, UNKNOWN REASON. PUMP WAS EXCHANGED. NEW PUMP PLACED ON PT. A POWER SURGE DEVICE WAS PLACED ON PUMP CHANGING DEVICE.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
IMPLANT WAS PLACED ON 7/11/95. NO GRAFTING OR OTHER EXTENUATING CIRCUMSTANCES. ONE ABUTMENT WAS IN FUNCTION.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. RETURNED IMPLANTS WERE EVALUATED AND FOUND TO MEET SPECIFICATIONS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANTS ARE NOT BELIEVED TO BE THE CAUSE OF FAILURE.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNK. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
SELF-TAPPING IMPLANT WAS PLACED ON 12/1/95. OTHER 4 IMPLANTS ARE FINE.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND MET SPECIFICATIONS. THE PT'S HYPERTENSIVE CONDITION LIKELY CONTRIBUTED TO THE IMPLANT FAILURE.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL LOADING OF IMPLANT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
IMPLANTS WERE PLACED ON 8/21/95. NO GRAFTING DONE. NO EXTENUATING CIRCUMSTANCES. BRIDGE WAS DONE ALREADY.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. AS THE IMPLANTS WERE NOT RETURNED, CO CANNOT EVEN BE CERTAIN THAT THEY ARE CO PRODUCTS.
IMPLANT WAS PLACED ON 8/21/95. NO GRAFTING DONE. NO EXTENUATING CIRCUMSTANCES. BRIDGE WAS DONE ALREADY. SITE #14.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. AS NO IMPLANT HAS BEEN RETURNED, CO CANNOT BE SURE IT IS A CO PRODUCT.
IMPLANT WAS PLACED ON 8/22/95. OTHER 2 IMPLANTS ARE FINE.
ANSWERS TO FREQUENCY AND SEVERITY QUESTION: NO, NO, YES, NO. THE IMPLANT HAS NOT BEEN RETURNED. CO CANNOT BE SURE IT IS A CO PRODUCT.
PT ON MSO4 50MG/ML-AT 60MG/HR CONTINUED WITH 10MG BOLUS EVERY 30 MINUTES. ON 8/2/96-FACILITY CALLED AT 0716 AM. PT REPORTED A PUMP HAD A SOLID GREEN SCREEN WITH NO PROGRAMMING INFO. PUMP HAD JUST BEEN TAKEN OFF THE CHARGE SYSTEM AND MALFUNCION OCCURRED. PT WAS INSTRUCTED TO CHARGE PUMP FROM ANOTHER ELECTRICAL OUTLET. THE PUMP SCREENS CAME UP. THE PUMP WAS NOW IN PAUSE, THE PT WAS INSTRUCTED TO START THE PUMP. THE PUMP WAS STARTED AND THE REPORTED INFO WAS ACCURATE. FACILITY VISITED THE PT AT 1600 HRS 8/22/96-TO VERIFY ALL WAS WELL. DOSING WAS CHANGED TO A 10MG BOLUS OF 20 MINUTES (3/HR). BOLUSES GIVEN TO COVER PT FOR PAIN. ON 8/23/96 FACILITY CALLED AT 0945-PT UNRESPONSIVE AND TUBING WAS LEAKING-PUMP OPERATING WITH OUT MALFUNCTION. ON 8/24/96 FACILITY TROUBLE SHOOTED PUMP.
AN 8 FR CATHETER INSERTED ON 8/14/96, A CHEST X-RAY REVEALED THAT A PORTION OF THE CATHETER WAS NOTED TO BE IN THE PT'S RIGHT ATRIUMAND SUPERIOR VENA CAVA. THIS WAS REMOVED PERCUTANEOUSLY BY AN INTERVENTIONAL RADIOLOGIST. THE PROXIMAL PORTION WAS REMOVED SURGICALLY.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING CLINICAL USE WITHIN A NON CALCIFIED HEMODIALYSIS ACCESS, THE BALLOON BURST AT AN INFLATION PRESSURE OF 16 ATMS. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED AN AXIALLY-DIRECTED TEAR, .6-5.3 CM AT THE DISTAL END. MICROSCOPIC EXAMINATION: FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS IN THE BALLOON MATERIAL ADJACENT TO THE TEAR. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION. FURTHER, AN AXIAL TEAR IS INDICATIVE OF INFLATION IN EXCESS OF THE RATED BURST PRESSURE (16 ATMOSPHERES) FOR THIS BALLOON.
RUPTURED BILATERAL SILICONE BREAST IMPLANT WAS REPORTED.
INVESTIGATION CONDUCTED. CAUSE FOR FRACTURE IS UNK. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
LOCKING SCREW MANDIBULAR PLATE BROKE POST-OPERATIVELY POSSIBLY DUE TO OVER BENDING OR INCREASED LOAD. SURGERY WAS REQUIRED TO REMOVE AND REPLACE THE PLATE.
MFR AWAITING ANALYSIS OF THE MANDIBULAR RECONSTRUCTION PLATE FOR FINAL EVAL. A FOLLOW-UP REPORT WILL BE FILED WITH THE EVAL RESULTS. FREQUENCY AND SEVERITY OF OCCURENCE: THIS EVENT IS NOT OCCURRING MORE FREQUENTLY NOR WITH GREATER SEVERITY THAN IS TYPICAL FOR THIS TYPE OF DEVICE. SINCE PRODUCT INTRODUCTION IN 1995 THE RATE OF REPORTED BROKEN BONE PLATES PER UNITED STATES UNITS SALES IS 0.5% FOR THIS FAMILY OF LEIBINGER PRODUCT.
CONCLUSIONS: PT FACTOR CONTRIBUTED TO FORMATION OF THROMBOSIS. NO FAILURE DETECTED AND PRODUCT WITHIN SPECS. A MFG RECORDS REVIEW CONFIRMED THIS VALVE SATISFIED ALL MATERIAL, DIMENSIONAL AND PERFORMANCE REQUIREMENTS AT THE TIME OF MFR AND RELEASE.
INVESTIGATION CONDUCTED. DR CITES PRESSURE ON MANDIBULAR NERVE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES INFECTION. SURGICAL TRAUMA AND BONE SITE NOT PERFECTLY HEALED AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
HOUSEKEEPING EMPLOYEE WAS PICKING UP CLOSED, FULL AND TAPED CONTAINER FROM SOILED UTILITY ROOM. REPORTEDLY RECEIVED NEEDSTICK FROM NEEDLE THAT HAD PUNCTURED THROUGH CONTAINER.
ONSITE VISIT COMPLETED 8/19/96, TO COLLECT DATA. LOT SPECIFIC INFO NOT AVAILABLE FROM FACILITY. REPORTED EVENT NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
DURING DRILLING OF BURR HOLE IN TEMPORAL BONE, DEVICE TORE DURA AND DID NOT DISENGAGE AS EXPECTED.
NOTE: NO MEDWATCH FORM HAS BEEN RECEIVED FROM THE USER FACILITY. MFG LOT RECORDS WERE RESEARCHED AND NO DISCREPANCIES DISCOVERED WITH THIS LOT. CASE DEBRIS INSIDE UNIT. SOME RUST NOTED INTERNALLY. DEBRIS & RUST REMOVED AND THE UNIT WAS REBUILT. DEVICE WAS TESTED FOR PROPER FUNCTION AND PERFORMED PROPERLY FOR TEN TEST HOLES. THE REPORTED FAILURE COULD NOT BE REPEATED.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNK. THIS FILE IS CLOSED. THE DREPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
A PT UNDERWENT SURGERY FOR OVARIAN CANCER. FIVE WEEKS POST-OP, WOUND DRAINAGE WAS NOTED. THE WOUND WAS RE-EXPLORED, DURING WHICH ABSCESS AND SINUS TRACT FORMATION WERE NOTED ALONG THE SUTURE LINE. ADHESIONS OF THE SMALL BOWEL TO THE OMENTUM AND THE ABDOMINAL WALL WERE ALSO NOTED. THERE WAS NO SUTURE BREAKAGE OR KNOTS UNTYING. THE SUTURE WAS USED FOR CLOSURE. THE PT IS DOING WELL. DR REPORTS GOOD EXPERIENCE WITH SUTURE. DR USED SUTURES FROM THE SAME BOX FOR SEVERAL PTS WITH JUST THIS ONE PT REACTION NOTED. THE DR THINKS THE REACTION WAS PROBABLY DUE TO IDIOSYNCRATIC RESPONSE OF THE PT.
LOT NUMBERS IN THE OPERATING THEATER-940625, 945395, 940184, 943620, 941810, AND 940661. ACTUAL LOT USED IS UNKNOWN. INVESTIGATION IS CURRENTLY UNDERWAY. FINAL REPORT WILL BE ISSUED WHEN THE INVESTIGATION IS COMPLETE. REFERENCE MFR COMPLAINT #Z96-277. PMA #P8400051.
CAPSULECTOMY WITH REMOVAL AND EXCHANGE OF IMPLANTS, BILATERAL. PT HAD RUPTURED RIGHT IMPLANT BUT HAD INTACT LEFT IMPLANT.
SOMETIME DURING A LAPAROSCOPIC PROCEDURE, CO2 LEAKAGE REPORTEDLY OCCURRED. THE SURGEON REPLACED THE VALVES AND SURGERY CONTINUED. COMPLETED DETAILS WERE NOT PROVIDED.
THIS IS A RESPONSE TO THE FDAS REQUEST FOR ADDITIONAL INFORMATION. MISSING INFORMATION FOR E1 WAS ENTERED. THE DISTRIBUTOR DID  NOT PROVIDE THE HOSPITAL OR SURGEON NAME AND ADDRESS. F10 IS TO BE COMPLETED BY DISTRIBUTORS. GM ENGINEERING IS A MFR. INITIAL MEDWATCH INSTRUCTIONS REQUESTED THE MFR TO COMPLETE PARTS OF SECTION F. H6: THE DEVICE WAS NOT PROVIDED TO THE MFR. AN EVALUATION WAS NOT PERFORMED.
CAPSULECTOMY WITH REMOVAL AND EXCHANGE OF IMPLANTS BILATERAL. RUPTURED IMPLANT RIGHT; INTACT IMPLANT LEFT.
INFANT WAS ON APNEA MONITOR AT HOME. MONITOR WAS TURNED OFF ON 8/10/96 AT 11:58 P.M. AND INFANT EXPIRED ON 8/11/96 AT APPROX. 7:00 A.M.
PT WAS A NEWBORN, TRANSFERRED TO CHILDREN'S HOSP ON 5/28/96, AFTER AN EMERGENCY DELIVERY BY CESAREAN SECTION AT ANOTHER HOSP. SHE HAD MECONIUM ASPIRATION SYNDROME. AN UMBILICAL ARTERIAL CATHETER WAS PLACED ON 5/28 FOR MONITORING BLOOD GASES AND ARTERIAL BLOOD PRESSURE. IT WAS REMOVED ON 6/11/96. ABDOMINAL ULTRASOUND (6/20/96) SHOWED THE PRESENCE OF A THROMBUS IN THE LEFT RENAL ARTERY. THE THROMBUS WAS FELT TO HAVE PROBABLY ORIGINATED AT THE SITE OF THE UMBILICAL ARTERIAL LINE. PERFUSION SCAN SHOWED DECREASED FUNCTION OF THE LEFT KIDNEY. THE RIGHT KIDNEY APPEARED NORMAL. IT IS LIKELY THAT SHE WILL HAVE ONLY ONE FUNCTIONING (RIGHT) KIDNEY.
KS WAS A NEWBORN, TRANSFERRED TO CHILDREN'S HOSP ON 5/28/1996, AFTER AN EMERGENCY DELIVERY BY CESAREAN SECTION AT ANOTHER HOSP. SHE HAD MECONIUM ASPIRATION SYNDROME. AN UMBILICAL ARTERIAL CATHETER WAS PLACED ON MAY 28TH FOR MONITORING BLOOD GASES AND ARTERIAL BLOOD PRESSURE. IT WAS REMOVED ON 6/11/1996. ABDOMINAL ULTRASOUND (6/20/1996) SHOWED THE PRESENCE OF A THROMBUS IN THE LEFT RENAL ARTERY. THE THROMBUS WAS FELT TO HAVE PROBABLY ORIGINATED AT THE SITE OF THE UMBILICAL ARTERIAL LINE. PERFUSION SCAN SHOWED DECREASED FUNCTION OF THE LEFT KIDNEY. THE RIGHT KIDNEY APPEARED NORMAL. IT IS LIKELY THAT SHE WILL HAVE ONLY ONE FUNCTIONING (RIGHT) KIDNEY.
REFERENCE MFR. COMPLAINT #A96-8-1-8. THE ACTUAL SAMPLE WAS DISCARDED. THE HOSP REFUSED TO SUPPLY ADDITIONAL INFO CONCERNING THE EVENT. NONE OF THE REPORTED LOT NUMBER REMAINED IN OUR DISTRIBUTION CENTERS. A CHECK OF OUR RECORDS FOUND NO SIMILAR COMPLAINTS REGISTERED ON THIS LOT. WITHOUT THE ACTUAL SAMPLE OR SAMPLES FROM THE SAME LOT NUMBER WE ARE UNABLE TO INVESTIGATE FURTHER. SHOULD SAMPLES (OR ADDITIONAL INFO) BECOME AVAILABLE WE WILL REOPEN THIS COMPLAINT.
PT UNDERWENT SKIN GRAFT ON HIS HAND. HE WAS GIVEN DRESSING TO USE ON HIS HAND. PT REPORTS, HE REACTED TO THE DRESSING AND NOW NEEDS FURTHER MEDICAL ATTENTION. HIS HAND BECAME IRRITATED AND HIS HAND AND ARM ARE SWOLLEN. SKIN GRAFT OPERATION 7/26/96. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
REFERENCE MFR. COMPLAINT X96-8-5-32. THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS PROVIDED. TESTING WAS PERFORMED FOR CYTOTOXICITY, PRIMARY SKIN IRRITATION, SENSITIZATION, ACUTE SYSTEMIC TOXICITY, HEMOLYSIS TEST, SUBCHRONIC TOXICITY TEST AND 7-DAY IMPLANTATION. THE PRODUCT PASSED ALL BIOLOGICAL TESTS. THERE WERE NO COMPLAINT RELATED DEFECTS IN THE LOT HISTORY AND NO SIMILAR REPORTS HAVE BEEN REPORTED AGAINST THIS LOT (OR REORDER NUMBER) FOR THE PAST THREE YEARS. THE PRODUCT IS WELL LABELED WITH ADVERSE REACTIONS, WARNINGS AND CONTRAINDICATIONS, WHICH WERE SENT TO THE COMPLAINT'S LAWYER. CO IS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED SKIN IRRITATION. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
A PT INJURY OCCURRED. AFTER REVIEW OF THE MDR, IT CAN BE DETERMINED THAT THE INJURY OCCURRED DURING, OR AFTER, RESECTION OF A HIGHLY CALCIFIED MENINGIOMA TUMOR, USING A COMBINED ASPIRATOR AND GRASPING FORCEPS TECHNIQUE. EXPERIENCE OR LITERATURE HAS REVEALED THAT ASPIRATION IS NOT AS EFFECTIVE FOR STRUCTURES WITHOUT HIGH WATER CONTENT. THE INFARCTION, OR SWELLING WERE NOTED. HOWEVER, IT WAS FELT NECESSARY BY THE PHYSICIANS TO INDUCE BARBITUATE COMA IN ORDER TO MINIMIZE ANY CHANCES OF BRAIN INJURY THAT MIGHT ARISE AS A RESULT OF THE OPERATION. THE PT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT STILL INTUBATED, AND IN A BARBITUATE COMA. IT IS THE CO'S UNDERSTANDING THAT THE PT REMAINS IN A COMA STATE, HOWEVER, THIS CAN NOT BE ASCERTAINED AS CO PERSONNEL HAVE BEEN UNSUCCESSFUL IN OBTAINING FURTHER DETAILS OF THE INCIDENT, BEYOND WHAT WAS SUBMITTED TO THE FDA THROUGH MDR. CO WILL CONTINUE ITS EFFORTS TO INVESTIGATE THE INCIDENT SO THAT SUFFICIENT ANALYSIS AND ASSESSMENTS CAN BE MADE BY THE DEVICE MFR, AT WHICH TIME THE FDA WILL BE APPRISED.
RN, DON REPORTED THAT APPROX. 10 MINUTES AFTER THE START OF TREATMENT, THE PT BECAME DIAPHORETIC. RR 30, BP185/120 WITH BILATERAL WHEEZING. THE PT'S SKIN WAS WARM. THE BLOOD FLOW RATE WAS TURNED DOWN FROM 300 TO 100, NASAL O2 ADMINISTERED AT 4L/MIN. THE PT'S BLOOD WAS NOT RETURNED, EBL>200CC. SYMPTOMS RESOLVED WITHIN 15 MINS. CULTURES OF THE DIALYSATE, RO, AND MACHINE WERE DONE. SAMPLE IS AVAILABLE AND A SAMPLE ENVELOPE WAS SENT TO THE FACILITY ON 8/22/96.
INVESTIGATION CONDUCTED. DR CITES POSSIBLE POST SURGICAL LOADING OF IMPLANT AS CAUSE FOR FAILURE. PT IS A SMOKER AND CONSUMES ALCOHOL. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNK. PT IS A SMOKER AND CONSUMES ALCOHOL. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
RN, DON REPORTED THAT DIALYSIS WAS INITIATED WITHOUT INCIDENT. APPROX. 20 MINUTES INTO TREATMENT THE PT COMPLAINED OF FEELING HOT, PT WAS AFEBRILE, BP 220/143. BLOOD CULTURES/2 WERE DONE. BENADRYL 25MG IV GIVEN. CXR AND EKG WERE OBTAINED. PT COMPLAINED OF FEELING WORSE; SOB, DIAPHORETIC, LISTLESS. THE TREATMENT WAS STOPPED AND THE PT'S BLOOD WAS NOT RETURNED. EBL>200CC. CULTURES OF ALL PRODUCTS USED WERE DONE. MD WANTED THE DIALYZER TESTED. SAMPLE ENVELOPE SENT TO THE FACILITY ON 8/22/96.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT IS A SMOKER CONSUMED ALCOHOL AND HAS POOR ORAL HYGIENE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING TESTING, THE UNIT WOULD NOT CHARGE PAST 6 JOULES. THIS HAPPENED AFTER THE 4TH SHOCK.
AFTER TERMINATION OF BYPASS FOR CORRECTION OF ACUTE TYPE A AORTIC DISSECTION, PT FAILED TO MAINTAIN ADEQUATE HEMODYNAMICS AND WAS DIAGNOSED WITH RIGHT VENTRICULAR FAILURE AND RESPIRATORY DISTRESS. EMCO WAS INITIATED ON 7/30/96. THERE WAS NOT ENOUGH IMPROVMENT TO SUSTAIN ADEQUATE HEMODYNAMICS WITHOUT ECMO. ECMO WAS DISCONTINUED AT DIRECTION OF FAMILY AND SURGEON AND PT EXPIRED ON 8/5/96. DURING ECMO, TEN (10) OXYGENATORS WERE USED. EACH PERFORMED WELL FOR SIX TO EIGHT HOURS BEFORE DEVELOPING PLASMA LEAKS. ONE STARTED TO LEAK AFTER FOUR HOURS. FOUR OXYGENATORS AVAILABLE FOR EVALUATION.
RN, DON REPORTED THAT APPROX. 20 MINUTES AFTER THE START OF TREATMENT THE PT BECAME DYSPENIC. PT'S RR WAS >20 AND THE BP WAS ELEVATED 180/110. THE PT COMPLAINED OF FEELING HOT BUT WAS AFEBRILE. THE PT WAS REINFUSED PER THE NEPHROLOGIST. SYMPTOMS RESOLVED AFTER REINFUSION. EBL>100CC. BLOOD CULTURES WERE DONE AND A CHANGE IN THE DIALYZER WAS PRESCRIBED. SAMPLE AVAILABLE AND A SAMPLE ENVELOPE WAS SENT TO THE FACILITY ON 8/22/96.
DURING UNIT CHECK OF CO LOANER, THE CUSTOMER NOTICED THE UNIT WOULD NOT ANALYZE A SHOCKABLE RHYTHM.
THE DEVICE WAS REMOVED DUE TO A "LEFT TUBING FRACTURE". THE ENTIRE DEVICE WAS REMOVED AND REPLACED.
REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
THE DEVICE WAS REMOVED DUE TO "TUBING TO LEFT CYLINDER WAS BROKEN". DEVICE COMPONENT(S) WERE REMOVED AND REPLACED; LEAVING THE RESERVOIR COMPONENT IN PLACE.
IN THE RECEIVED INFO THE PHYSICIAN NOTED LEAKAGE STATING "TUBING LEAK RIGHT SIDE WITH COMPLETE TUBING SEPARATION OF LEFT SIDE." THE PHYSICIAN FURTHER STATED THAT THERE WERE NO KINKS OR TWISTS OBSERVED, THAT THERE WAS NEITHER AN EXCESS NOR AND INADEQUATE LENGTH OF TUBING OBSERVED, AND THAT THE DEVICE WAS NOT IN A POSITION THAT WOULD HAVE CAUSED STRESS(S). THE PHYSICIAN ALSO STATED THAT THERE WAS NO INFO IN THE PT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE. QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVAL. THE HOSP INDICATED THE DEVICE WILL NOT BE RELEASED FOR EVAL. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PRECLUDED FROM COMMENTING ON THE CONDITION OF THE PROSTHESIS. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
FACILITY ALLEGED THAT APPROX. FOUR HOURS AFTER INITIATION OF HEMODIALYSIS TREATMENT THE PT'S VENOUS NEEDLE DISLODGED AND BLOOD WAS NOTED ON THE   FLOOR. THE BLOOD PUMP WAS STOPPED; THE LINES CLAMPED. THE PT WAS SLEEPING AT THE TIME OF THE EVENT AND WAS BELIEVED TO HAVE JERKED HIS ARM. THE PT WAS AROUSABLE AND THEN LOST CONSCIOUSNESS FOR SEVERAL SECONDS. THE PT RESPONDED TO A SALINE BOLUS AND WAS ALERT AND ORIENTED. THE PT WAS TRANSFERRED TO THE HOSP EMERGENCY ROOM, WAS SEEN AND RELEASED. EBL 500CC. FACILITY STATED THAT THE VENOUS PRESSURE ALARM DID NOT GO OFF AT THE TIME OF THE EVENT. HOWEVER, THE VENOUS PRESSURE MONITORING TRANSDUCER PROTECTOR WAS NOTED TO BE BLOODY AT THE TIME OF THE EVENT AND MAY NOT HAVE BEEN MONITORING PROPERLY. THE FACILITY ALSO STATED THAT THEY HAVE BEEN HAVING PROBLEMS WITH THE TP'S BACKING UP. ANOTHER CO'S HEMO MACHINE WAS PULLED AND CHECKED AND ALL THE ALARMS FUNCTIONED PROPERLY. THE FACILITY ALSO STATED THAT THEY ARE NOT SURE WHAT CAUSED THE PROBLEM. THE PT RETURNED TO THE CLINIC FOR TREATMENT ON 8/8/96 WITHOUT INCIDENT.
THE DEVICE WAS REMOVED DUE TO A "TUBING RUPTURE AT RESIPUMP". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A CO 2-PIECE.
IN THE RECEIVED INFO THE PHYSICIAN STATED THAT LEAKAGE WAS NOTED "AT CONNECTOR." THE PHYSICIAN ALSO STATED THAT THERE WAS NO KINKING OR TWISTING OF THE TUBING OBSERVED, THE DEVICE WAS NOT IN A POSITION THAT WOULD HAVE CAUSED STRESS, AND THAT THERE WAS NEITHER AN EXCESS NOR AN INADEQUATE AMOUNT OF TUBING OBSERVED. THE PHYSICIAN FURTHER STATED THAT THERE WAS NO INFO APPARENT IN THE PT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE AND THAT THE DEVICE WAS NOT DAMAGED DURING THE EXPLANT PROCEDURE. EXAMINATION AND TESTING OF THE DEVICE REVEALED A SEPARATION/LEAKAGE SITE IN OUTLET #1'S EXITING TUBING. THIS SEPARATION EXTENDS AROUND THE TUBING, ALONG THE MONOFILAMENT CAVITY, NEAR THE DISTAL END. EXAMINATION OF THE SURFACES OF THE SEPARATION REVEALED MARKINGS CHARACTERISTICS OF STRESS9S0 INDUCED RENDING. FURTHER EXAMINATION OF THE AREA SURROUNDING THE SEPARATION REVEALED CONNECTOR IMPRESSION MARKS ON THE SURFACE OF THE TUBING. THE LOCATION OF THE SEPARATION SITE, WITHIN THE CONNECTOR/CLAMP MARKINGS, INDICATES THAT THE SEPARATION MAY HAVE ORIGINATED AT THE TUBING/CONNECTOR POINT OF CONTACT, CONFIRMING THE PHYSICIAN'S OBSERVATIONS. EXAMINATION ALSO REVEALED A CONFINED AREA OF ABRASION WITH A CREASE MARK ADJACENT OT IT, ON EACH OF THE EXITING TUBINGS AT THE STRAIN RELIEF/TUBE JUNCTION. BASED ON QA'S EXAMINATION AND THE PHYSICIAN'S OBSERVATIONS. QA CONCLUDED THAT WHILE IN-VIVO, BOTH OUTLET TUBINGS WERE PARTIALLY KINKED AND ABRADING AGAINST THEMSELVES. QA FURTHER CONCLUDED THAT THIS POSITIONING, COMBINED WITH TUBING FATIGUE AT THE CONNECTOR SITE, AND THE DEVICE USAGE, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBING AT THE OBSERVED SITE.
CUTTER WAS USED IN RECONSTRUCTIVE SURGERY FOR BLADDER AUGMENTATION. THE LINEAR CUTTER FAILED TO OPERATE PROPERLY DURING BOWEL ANASTOMOSIS. FIRST TIME IT WORKED, SECOND TIME SOME STAPLES OPEN AND DIDN'T CUT ALL THE WAY. THIRD TIME HAD A VERY HARD TIME WITH IT AND IT DIDN'T CUT AFTER SECOND TIME REFILLED CARTRIDGE. SURGEON HAND OVERSEWED THE BOWEL ANASTOMOSIS, PROLONIGING SURGERY BY 1 HOUR. NG TUBE LEFT IN LONGER.
THE DEVICE WAS REMOVED AS IT WAS "INFECTED WITH PUS". THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED. ADDITIONALLY, "TRIED TREATMENT WITH ANTIBIOTICS AND DRAINAGE, BUT FAILED". ON 8/26/96, CO OFFICE RECEIVED THE REMAINING COMPONENT(S) OF THIS DEVICE; CYLINDER(S) AND RESERVOIR". IT WAS REPORTED AT THE TIME, THAT THE REMAINDER OF THE DEVICE WAS REMOVED ON 7/25/96 DUE TO "INFECTION".
QA RECEIVED THE DEVICE FOR EVAL. EXAM OF THE DEVICE REVEALED NO APPARENT FACTORS WHICH WOULD CONTRIBUTE TO THE REPORT OF INFECTION. HOWEVER, SINCE DEVICE EVAL WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION, QA WILL ACCEPT THE PHYSICIAN'S DIAGNOSIS OF THIS AS THE CAUSE FOR REMOVAL. QA REVIEWED THE STABILITY RECORDS FOR THIS DEVICE LOT AND CONFIRMED THAT IT WAS ACCEPTED ACCORDING TO QUALITY ASSURANCE AND MFG PROCEDURES FOR RELEASE. BASED ON THIS QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE OPENING OF THE DEVICE PACKAGE AND THAT THE INFECTION INITIATED FROM A SOURCE OR SOURCES OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
IMPLANT FAILED TO INTEGRATE. PER DR, PT IS A SMOKER AND IN GOOD GENERAL HEALTH.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. THE PT'S SMOKING IS THE LIKELY CAUSE OF FAILURE.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND MEETS SPECS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE. MEDICAL HISTORY FOR IMPLANT WAS RECEIVED AND INDICATES THAT PATIENT IS A SMOKER. THE SMOKING IS THE LIKELY CAUSE OF FAILURE.
IMPLANT PLACED 6/17/96, SITE #29. IMPLANT REMOVED 7/22/96. PATIENT WENT IN WITHOUT PAIN OR SWELLING. IMPLANT FELL OUT AFTER 1 MONTH. TYPE II BONE.
IMPLANT WAS PLACED ON 1/3/96. REMOVED ON 7/31/96. PT SMOKES 1 1/2 PACKS PER DAY.
ON 7/30/96, A CREW ARRIVED TO FIND A MALE AGED 74 IN CARDIAC ARREST. HE WAS APPROX 175 LBS. THE CREW ATTACHED THE DEVICE AND WAS ABLE TO SHOCK THE PT ONE TIME AT 200 J, THEN THE UNIT REPORTEDLY PROMPTED "CHECK ELECTRODES." THE CREW REPLACED THE PADS, BUT GOT THE SAME PROMPT. PARAMEDICS ARRIVED, TOOK OVER PT CARE, AND TRANSPORTED THE PT TO A HOSP. PT OUTCOME IS UNKNOWN AT THIS TIME.
DEVICE EVALUATION SUMMARY: THE RETURNED DEVICE WAS INVESTIGATED AND ANALYZED BY A SCV. A TRANSFER RELAY WAS FOUND TO BE INTERMITTENT, CAUSING THE DEVICE TO DISPLAY "CHECK ELECTRODES." THE RELAY WAS REPLACED AND PROPER OPERATION OF THE DEVICE AS VERIFIED. THE UNIT WAS THOROUGHLY TESTED TO ALL DEVICE SPECIFICATIONS AND WAS FOUND TO BE FULLY COMPLIANT WHILE OPERATING NORMALLY THROUGH ALL TESTS COMPLETED. FINALLY CO'S SVC DEPT SUCCESSFULLY CONDUCTED A  FUNCTIONAL ARRHYTHMIA TEST WITHOUT OBSERVING ANY PERFORMANCE DEVIATIONS OR IRREGULARITIES.
FACILITY REPORTED ARTERIAL DRIP CHAMBER INLET LINE GOES COMPLETELY TO THE BOTTOM OF THE DRIP CHAMBER AND NOT ALLOWING THE CHAMBER TO FILL UP. NO PT INJURY REPORTED.
DEVICE WAS PLACED IN PT BY PHYSICIAN. NURSE NOTED NO DRAINAGE. DEVICE REMOVED AND REPLACED 7/29/96. TUBE WAS NOTED TO HAVE NO EYES. PER NURSING SUPV, PT SUFFERED NO SEQUELAE.
DEVICE CODE 2203=NO CODE GIVEN FOR MISSING EYES. 510K = K880850, K830710. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFORMATION NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED. VOLUNTARY MEDWATCH REPORT #1009727 REC'D BY CO ON 8-29-96. ACTUAL DEVICE WAS RETURNED AND EVALUATED. THE SAMPLE RETURNED (UNK LOT #) WAS CONFIRMED TO THE MISSING DRAINAGE EYES. SAMPLES OF THE CUSTOMER'S INVENTORY (LOT 453748) WERE ALL FOUND TO HAVE DRAINAGE EYES. A REVIEW OF THE LOT HISTORY FOR THE IDENTIFIED LOT, FOUND NO DEFECTS DURING PRODUCT INSPECTION AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED AGAINST THAT LOT. MFG FEELS THIS DEFECT IS AN ISOLATED EVENT, DUE TO OPERATOR ERROR. THE RETURNED SAMPLE WAS DISPLAYED AT THE PLANT FOR AWARENESS OF ALL PERSONNEL.
PERSON REPORTS THAT CONDOM BROKE DURING SEXUAL INTERCOURSE. THIS HAPPENED AGAIN WITH SAME BATCH OF CONDOMS. ALSO TEN OTHER PEOPLE COMPLAINED OF BREAKAGE AFTER GETTING CONDOMS FROM FACILITY. ONLY 200 HAD BEEN DISTRIBUTED AT THAT TIME. THESE PEOPLE HAD RECEIVED INFO ON THE CORRECT USAGE OF CONDOMS.
RESIDENT HAD BEEN PLACED IN SHOWER CHAIR. CNA WAS TRANSPORTING PT TO SHOWER ROOM WHEN WHEEL OF CHAIR ROLLED OVER DOOR ENTRY MAT. PVC CHAIR LEG SPLIT CAUSING RESIDENT TO PITCH FORWARD FROM CHAIR. CNA INJURED BACK IN SUCCESSFUL ATTEMPT TO CUSHION RESIDENT FALL. CHAIR WAS PURCHASED BECAUSE IT WAS ABLE TO SUSTAIN WEIGHT OF THIS RESIDENT.
NO CLAMP @ VENOUS CHAMBER ACCESS PORT. REPORTER USES THIS ACCESS FOR MEDS. A DANGER TO PT SAFETY.
ARTERIAL TRANSDUCER CAP WON'T DISCONNECT.
THE PRODUCT WAS TAKEN OUT OF THE PACKAGE AND IT WAS CONTAMINATED INSIDE THE BARREL.
PIGTAIL" END OF RENAL CATHETER DISLODGED FROM THE CATHETER AND WAS RETAINED INSIDE RENAL CYST.
IT WAS REPORTED FOR 3 DEVICES, THAT THE INFLATION LINE TO THE TRACH TUBE CUFF BROKE AT THE FLANGE AFTER 2 TO 3 DAYS OF USE. ALL 3 DEVICES WERE FROM THE SAME LOT NUMBER. IT WAS MENTIONED THAT THE CHILD MAY BE PLAYING WITH THE TUBE. NO PT INJURY WAS REPORTED. THE PT IS AT BASELINE CONDITION.
EVALUATION RESULTS: THE MFRS ANALYSIS AND INVESTIGATION OF THE TWO RETURNED UNITS INDICATE THAT ON UNIT #1, THE INFLATION LINE WAS PARTIALLY SEPARATED FROM THE FLANGE WITH A JAGGED TYPE OF CUT AND ON UNIT #2 THE INFLATION LINE WAS COMPLETELY SEPARATED. BOTH UNITS HAD A WHITE RESIDUE INSIDE THE CONNECTOR AND ON THE NECKPLATE. THE PULL(TENSILE) STRENGTH OF THE INFLATION LINES WERE TESTED WITH ACCEPTABLE RESULTS. THE EXACT CAUSE(S) OF THE MATERIAL SEPARATION CANNOT BE DETERMINED. IT APPEARS, BASED ON COMPLAINT REPORT THAT THE PT MAY BE PULLING OR MANIPULATING THE INFLATION LINE.
IMPLANT WAS PLACED ON 3/19/96 AND REMOVED ON 7/17/96. PT SMOKES 1 1/2 PACKS PER DAY.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANTS WERE EVALUATED AND FOUND TO MEET SPECIFICATIONS. THE PT'S SMOKING IS THE LIKELY CAUSE OF FAILURE.
REPORTER COMPLAINS OF: WEIGHT LOSS, RHEUMATOID ARTHRITIS, PANIC ATTACKS, SEVERE BONE PAIN, INTERMITTENT LOW GRADE FEVER, SWELLING, UNABLE TO WALK, BRUISING, MUSCLE SPASMS, TWITCHING, BLURRED VISION, "OCCASIONAL LOSS OF VISION", CHRONIC RASHES, LESIONS, BLEEDING, VOMITING, CHRONIC FATIGUE, INCONTINENCE, LUMPS (" ? SILICONE DEPOSITS"), SWOLLEN LYMPH GLANDS, INSOMNIA, DAY/NIGHT SWEATS, DIZZINESS, NUMBNESS, OSTEOPOROSIS, TMJ, CIRCULATION PROBLEMS, CHRONIC SORE THROAT, MOUTH ULCERS, DISABLED, SHORT TERM MEMORY, AND HAIR LOSS. IMPLANT DATE: 12/13/84.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
ON TWO SEPARATE OCCASIONS THE PVC PIPING HOLDING THE WHEELS OF THIS SPECIAL WALKER/WHEELCHAIR SPLIT. ALTHOUGH NO INJURY OCCURRED AT THE TIME OF EITHER INCIDENT, THE POTENTIAL FOR SERIOUS INJURY IS VERY REALISTIC CONSIDERING THE TYPE OF RESIDENT OR DISABLED PERSONT HE UNIT IS DESIGNED FOR. THIS INCIDNET RESEMBLES THE INCIDENT NOTED WHEN USING A PVC SHOWER CHAIR. MAINTENANCE PERSONNEL ARE EXPRESSING CONCERN OVER THE WEAKNESS NOTED IN PVC PIPING MEDICAL DEVICES.
BALLOON RUPTURED AT AN INFLATION PRESSURE OF 18 ATMS. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO PROVIDED BY CO. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON TWO RETURNED PRODUCTS THAT WERE USED WITHIN THE SAME PT: VISUAL EXAM: TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE BALLOONS. THE BALLOONS EXHIBITED AXIALLY-DIRECTED TEARS, 0.7 CM PROXIMAL TO THE DISTAL TIP AND SEAL TO SEAL, RESPECTIVELY. ALTHOUGH THE EXACT CAUSE FOR THE BALLOONS' TEARS COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOONS WERE EXPOSED TO UNIDENTIFIED SOURCES OF  ABRASIONS.
NURSE WAS PLACING A MID-ARM INFUSION CATHETER INTO CLIENT'S VEIN. AFTER INSERTION, NURSE ATTEMPTED TO REMOVE THE BREAKAWAY NEEDLE. IT DID NOT COMPLETELY BREAK AWAY AND LEFT THE HUB AND HALF OF THE NEEDLE ON THE LINE. THIS WAS REMOVED USING A CLAMP.
PLASTIC COMPONENT SEPARATED FROM METAL COMPONENT. DEVICE WAS REMOVED AND REPLACED.
INFUSION PUMP MALFUNCTIONED. PT WAS RECEIVING A PRESCRIPTION PAIN MANAGEMENT MEDICATION INTRAVENOUSLY VIA PUMP. 8/14/96: RN OF THE LONG TERM CARE FACILITY CALLED PHARMACY TO INFORM THEM AN ERROR CODE ON PUMP READ OUT, WHICH WAS REPORTED TO MFR'S CLINICAL ASSISTANCE. THE PT WENT WITHOUT PAIN CONTROL FOR 1 1/2 HOURS WHILE PHARMACY DELIVERED A REPLACEMENT UNIT TO HER. SHE WAS NOT INJURED. THE ERROR CODE E63 ON THIS DEVICE INDICATES AN INTERNAL MALFUNCTION, ACCOARDING TO THE MFR. PUMP RETURNED TO MFR 8/20/96.
TUNGSTEN WEIGHT WAS SEEN ON X-RAY TO BE OUTSIDE THE SILICONE RUBBER FEEDING TUBE. THE TUBE HAS BEEN REMOVED. THE BABY IS BEING MONITORED TO SEE IF THE TUNGSTEN WEIGHT WILL PASS THROUGH THE SYSTEM WITH THE BABY'S FECES. THE TUBE WAS ONLY ON 3 DAYS.
THE TUBE WAS RETURNED BY THE HOSPITAL, IT WAS SENT TO FOREIGN CO AFFILIATE FOR EXAMINATION ON 9-11-96. AWAITING RESULTS OF THE ANALYSIS. DATA A1,A3,A4 & D10 NOT REPORTED TO CO. THIS SHOULD BE SOUGHT FROM THE HOSPITAL. A MICROSCOPIC EXAMINATION REVEALED THE TUBE HAD BEEN CUT WITH A SHARP INSTRUMENT. HAVE ASKED CLINICIAN TO CHECK WHETHER AN ABDOMINAL PROCEDURE WAS CARRIED OUT WHICH COULD HAVE CAUSED THE TUBE TO BE INADVERTENTLY CUT.
PT HAVING A RIGHT TOTAL HIP ARTHROPLASTY. DURING TRIAL REDUCTION WITH TRIAL PROSTHESIS, THE 28MM + 8 TRIAL FEMORAL HEAD (NON RADIOPAQUE) CAME OFF THE FEMORAL STEM IN THE RIGHT HIP INCISION. MULTIPLE ATTEMPTS WERE MADE TO LOCATE THE TRIAL HEAD WITHOUT SUCCESS. THE FEMORAL HEAD WAS LEFET IN THE PT. REMAINDER OF INSTRUMENTS AND SUPPLIES RETURNED TO MFR REPRESENTATIVE ON 6/12/96.
USE OF LATEX GLOVES EACH DAY FOR TWO YEARS CAUSED EXPLOSIVE DIARRHEA, ABDOMINAL CRAMPING, AND OCCUPATIONAL ASTHMA, AND SINUSITIS.
RPTR HAD BACK SURGERY AND THE IMPLANTATION OF PEDICLE SCREWS AND RODS. RPTR IS IN CONSTANT PAIN AND CANNOT SIT, STAND OR LIE DOWN FOR MORE THAN TWO HOURS AT A TIME. RPTR IS ON CONSTANT PAIN MEDICATION.
THE PHYSICIAN SUCCESSFULLY POSITIONED AN ESOPHAGEAL STENT IN A LONG STRICTURE. THE NEXT DAY IT WAS NOTED THE STENT MIGRATED INTO THE STOMACH. SEVERAL ATTEMPTS TO RETRIEVE THE STENT WERE MADE WITH A POLYPECTOMY SNARE AND A RAT-TOOTHED FORCEPTS, MET WITH NO SUCCESS. THE PHYSICIAN ELECTED TO LEAVE THE STENT IN THE PT'S STOMACH, AND ATTEMPT A RETRIEVAL AT A FUTURE DATE. THE PT IS IN SATISFACTORY CONDITION.
THIS REPORT IS BASED ENTIRELY ON UNCONFIRMED INFO SUBMITTED BY OTHERS. NEITHER THE SUBMISSIION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENDED TO BE AN ADMISION THAT ANY CO DEVICE (I) IS DEFECTIVE OR MALFUNCTIONED OR (II) CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. WE DO NOT BELIEVE THAT THIS REPORTED INCIDENT IS LIKELY OT REOCCUR.
PT HAD A TEFLON IMPLANT INSERTED IN 1986. THE PROSTHESIS WAS INSERTED INTO THE RIGHT TEMPOROMANDIBULAR JOINT. PT DEVELOPED PAIN ON OPENING AND CLOSING OF JAW DURING LAST SEVERAL MONTHS. CT SCAN REVEALS CONSIDERABLE AREA OF DEGENERATION OF THE MANDIBULAR CONDYLE AND BONE REACTION OF THE TEMPORAL BONE.
THE MACHINE IS A RADIATION DEVICE USED TO RADIATE DOSES FOR PTS WITH CANCER. THE MACHINE DOSE COUNTERS STOPPED SHORT OF THE PROGRAMMED DOSE. THE BACKUP VERIFIER INDICATED THE CORRECT PROGRAM DOSE. DURING TESTING, COUNTER DISPLAY SOMETIMES PAUSED ALTHOUGH DOSE WAS STILL BEING DELIVERED. TESTING INDICATED THAT THE CORRECT DOSE WAS DELIVERED AND THE PROBLEM WAS THE DISPLAY ONLY. WITHOUT A VERIFIER, THE INCORRECT DOSE WILL BE RECORDED FROM THE DISPLAY.
PT UNDERWENT CATARACT SURGERY ON 8/6/96, AND IMPLANTATION OF A INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON NOTICED A POSTERIOR CAPSULAR TEAR PRIOR TO INSERTION AND HE PERFORMED AN ANTERIOR VITRECTOMY. MEANWHILE, THE LENS WAS LOADED AND BSS WAS APPLIED BUT THE SURGEON LET THE CARTRIDGE SIT TOO LONG, APPARENTLY ALLOWING THE LENS TO DRY OUT. AS THE SURGEON ATTEMPTED TO INSERT THE LENS IT EJECTED FROM THE CARTRIDGE AND TORE IN HALF. HALF OF THE LENS WENT INTO THE EYE AND REQUIRED SECONDARY SURGICAL INTERVENTION TO REMOVE IT. THE PT WAS INJURED DURING LENS REMOVAL AND HAD A CHOROIDAL HEMORRHAGE.
THE PT'S VISUAL ACUITY IS LIGHT PERCEPTION AND THE SURGEON FEELS HE MAY LOSE HIS VISION. A SECOND SURGERY WAS NECESSARY TO DRAIN BLOOD FROM THE OPERATIVE EYE. THE SURGEON FELT THIS ADVERSE EVENT WAS DUE TO THE INJECTION SYSTEM. THE PROGNOSIS FOR THE PT IS POOR. THE LENS WAS RETURNED FOR EVAL (ATTACHED), HOWEVER THE INJECTOR AND CARTRIDGE WERE NOT RETURNED AND COULD NOT BE EVALUATED. THE RATE OF OCCURRENCE OF THIS EVENT CANNOT BE DETERMINED AS IT IS NOT ADDRESSED IN THE PRODUCT LABELING. LENS BOX WAS RECEIVED. THE BOX CONTAINED 6 CHART LABELS, THE PT ID CARD, AND THE LENS TRAY. THE LENS TRAY CONTAINED THE LENS, HELD IN BY TAPE. NO INJECTOR CARTRIDGE WAS RECEIVED. THE LENS WAS REMOVED FROM THE TRY AND INSPECTED FOR ANY DEFECTS CAUSING THE LENS TO TEAR WHEN IT EXITED THE CARTRIDGE. THE LENS HAS DRIED BBS/VISCOELASTIC RESIDUE. ONLY A PORTION OF THE OPTIC WITH ONE HAPTIC WAS RECEIVED. IN LIEU OF ANY DAMAGE CAUSED BY EXPLANTATION, THE DAMAGE TO THIS LENS MAY HAVE OCCURRED IF THE INJECTOR PLUNGER RODE OVER THE LENS DURING INSERTION. THE LENS MUST BE INCARCERATED FOR THIS TO OCCUR. THE LENS WAS MOST LIKELY UNDER LUBRICATED OR MISALIGNED IN THE CARTRIDGE LOADING AREA.
HEARING AIDS PURCHASED DO NOT PROPERLY FIT THE EAR CANALS. THE POOR PHYSICAL FIT SIGNIFICANTLY LIMITS THE VOLUME CAPABILITY OF THE HEARING AIDS. RECASING THE HEARING AIDS SHOULD IMPROVE THE SITUATION. THIS WOULD INVOLVE TAKING NEW IMPRESSIONS OF THE EARS.
REPORT OF ALLEGED "NO LEADS, NO AUDIBLE ALARM."
F.6) MFR NOT REQUIRED TO COMPLETE THIS SECTION AS NO MEDWATCH FORM 3500A WAS RECEIVED FROM USER/DISTRIBUTOR.
POST PROCEDURE THE PT COMPLAINED OF "FEELING WET" IN THE GROIN AREA. UPON EXAM, EXTENSIVE BLEEDING WAS NOTED FROM THE INSERTION SITE OF THIS DEVICE. MANUAL PRESSURE WAS APPLIED AND A BLOOD TRANSFUSION WAS ADMINISTERED. UPON REMOVAL OF THE DEVICE IT WAS NOTED THAT THE HUB HAD DETACHED. THE PT IS REPORTED AS FINE.
REPORT OF ALLEGED "MOTORSTALL, UNIT DID ALARM. NO PT HARM."
F.6) MFR NOT REQUIRED TO COMPLETE THIS SECTION AS NO MEDWATCH FORM 3500A WAS RECEIVED FROM USER/DISTRIBUTOR. H.6) CONCLUSION: TESTING BY MFR. COULD NOT REPEAT INITIAL FAILURE MODE. REPLACED MOTOR BOARD AND STATOR AS A PRECAUTION.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT FROM TEMPORATY PROSTHESIS AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
VENTILATOR HAD ALARMED AND NO LONGER PUMPED AIR. PT MANUALLY VENTILATED AND TRANSPORTED TO HOSP. PT PLACED ON BACK UP VENTILATOR AND RETURNED HOME. NO PT HARM.
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F. LABELING-#1738. TESTING BY MFR FOUND A CONTINUOUS CYCLE, NO VOLUME DELIVERED, WITH AUDIBLE AND VISUAL ALARMS, DUE TO CRANK ARM SET SCREW NOT SECURED, CAUSING CRANK KEY TO FALL OUT OF CRANK ARM. REPORTED FAILURE IS ATTRIBUTED TO SERVICE PERFORMED BY FIELD SERVICE PERSONNEL.
DURING CLINICAL USE, THE BALLOON RUPTURED AT AN INFLATION PRESSURE OF 7 ATMS. THERE WAS NOT REPORT OF PT INJURY OR COMPLICATIONS.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO PROVIDED BY CO. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAM: TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE BALLOON AND GUIDE WIRE. FUNCTIONAL TESTING: THE BALLOON WAS PRESSURIZED WITH WATER, WHICH REVEALED THE PRESENCE OF A SMALL LEAK SOURCE, 1.6 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAM: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING AND ADJACENT TO A SMALL CIRCUMFERENTIALLY-DIRECTED TEAR, ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NO BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
INVESTIGFATION CONDUCTED. CAUSE FOR FAILURE IS UNK. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
A BALLOON DETACHED FROM THE SHAFT WHEN BEING REMOVED DURING A SUBCLAVIAN VEIN ANGIOPLASTY WITH A DIALYSIS GRAFT. THE BALLOON REMAINED PARTIALLY INFLATED AND A NEEDLE WAS INSERTED IN THE ARM TO DEFLATE THE BALLOON. THE BALLOON WAS SUCCESSFULLY RETRIEVED WITH A SNARE. THE DILATATION WAS SUCCESSFUL AND THE PT HAS SINCE BEEN DISCHARGED. THE DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS USER FACILITY. THE ENGINEERING EVAL INDICATED THE CATHETER SHAFT WAS NOT RETURNED. THE BALLOON MATERIAL WAS NINE CENTIMETERS LONG FROM END TO END AND APPEARS TO HAVE ONE OF THE BALLOON NECK/BOND AREAS ATTACHED. THE BALLOON SURFACE WAS VERY WRINKLED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVER-PRESSURIZATION OR USE IN A CALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY    NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. THIS BALLOON DETACHMENT MAY HAVE RESULTED FROM PT'S PRE-EXISTING CONDITION, THEREFORE, CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE.
1586-NOT LABELED. 1149-LABELED. 2177-NOT LABELED.
DURING CLINICAL USE, THE BALLOON RUPTURED AT AN INFLATION PRESSURE OF 18 ATMS. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO PROVIDED BY CO. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAM: TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE BALLOON. A 0.5 CM LONG, AXIALLY-DIRECTED TEAR WAS NOTED, 1.5 CM PROXIMAL TO THE DISTAL TIP. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON TEAR COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
PT WAS X-RAYED FOR POSSIBLE EVIDENCE OF CONSTRUCT LOOSENING. X-RAY REVEALED LOOSE HEX BOLTS THAT ARE USED TO APPLY PRESSURE TO THE CONSTRUCT ASSEMBLY. PT WAS RE-OPERATED ON AND CONSTRUCT WAS TIGHTENED. THREADS OF THE HEX BOLTS WERE DEFORMED BY THE DR TO SAFELY LOCK THE SCREWS IN PLACE.
RECEIVED X-RAY FILMS FROM REP. ON 9-27-96. FILMS WERE EVALUATED AND APPEAR TO INDICATE THE CONSTRUCT WAS NOT ADEQUATELY TIGHTENED AT THE TIME OF THE INITIAL SURGERY, 5-14-96. THE REVISION (INTERVENTION) SURGERY, PERFORMED 8-8-96, POST-OP FILMS CLEARLY SHOW THAT A CRITICAL CONSTRUCT COMPONENT, P/N SS-1000-11T, C-SPACER (2 PCS) WERE NOT INSTALLED ON THE CONSTRUCT WHEN THE REVISION SURGERY WAS PERFORMED. THE FILMS ALSO SHOW THE CONSTRUCT APPEARS TO BE LOOSENING. THE OMISSION OF THE C-SPACER COMPONENTS ON THE CONSTRUCT ARE LIKELY TO NOT PROVIDE PROPER TIGHTENING OF THE CONSTRUCT. THE REP. STATED, BY PHONE CONVERSATION, THAT THE SURGEON THOUGHT THE C-SPACER COMPONENTS WERE WORTHLESS. THE SURGEON STATED THAT HE IS AWARE THAT THE CONSTRUCT IS LOOSENING BUT DOES NOT INTEND TO PERFORM SURGICAL INTERVENTION UNLESS THE PATIENT COMPLAINS. THE DR. STATED, "I TREAT THE PATIENTS, NOT THE X-RAYS". LOOSENING OF THE CONSTRUCT MAY LIKELY BE THE RESULT OF SURGEON ERROR BY NOT ADEQUATELY TIGHTENING THE CONSTRUCT DURING IMPLANTATION.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. POSSIBLE PRESSURE ON IMPLANTS FROM DENTURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
A PT HAD A REACTION DURING TREATMENT. PT COMPLAINED OF CHEST PAIN AND SHORTNESS OF BREATH DURING TRIAL USE OF DIALYZER. PT WAS GIVEN NORMAL SALINE, TWO SUBLINGUAL NITROGLYCERIN AND TREATMENT WAS TERMINATED. PT WAS TRANSFERRED TO ICCU WITH DIAGNOSIS OF DIALYSIS INDUCED ANGINA WITHOUT MYOCARDIAL INFARCTION. PT WAS DISCHARGED ON 8/6/96 FULLY RECOVERED.
CO WAS ASKED TO FILL IN THIS SECTION, EVEN THOUGH NO ADD'L NARRATIVE IS AVAILABLE.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL LOADING OF IMPLANT AS CAUSE FOR FAILURE. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYEP OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPROTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
A USER SUSTAINED A BROKEN SHOULDER AS A RESULT OF HIS MANUAL WHEELCHAIR TIPPING BACKWARDS. THE ANTI-TIPPERS WERE NOT PROVIDED WITH THIS CHAIR. THIS IS IN CONFLICT WITH THE EQUIPMENT SUPPLIER'S REPORT. THE USE OF ANTI-TIPPERS IS A DECISION MADE BY THE USER AND THE USER'S HEALTHCARE PROFESSIONAL.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUSAL FOR THIS TYPE OF DEVICE.
SHORT PLASTIC TUBE ATTACHED TO PLASTIC SPIKE HOUSING SEPARATED CAUSING CHEMO SOLUTION TO SPILL ON NURSE ADMINISTERING MEDICATION. IN A SEPARATE INCIDENT AN IV SOLUTION WAS NOTED TO BE LEAKING FROM THE SAME CONNECTION. THE POTENTIAL PRODUCT DEFECT APPARENTLY WAS KNOWN TO SOME NURSES SINCE THEY WOULD SCOTCH TAPE THE TWO PIECES TOGETHER SO THEY WOULDN'T SEPARATE.
INVESTIGATION CONDUCTED. DR CITES INFECTION FROM INADEQUATE FLAP CLOSURE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
JAW OF DEVICE FRACTURED. NO PT INVOLVEMENT REPORTED.
EVAL CODES FOR SECTION H6: 86. A HARDNESS AND DIMENSIONAL CHECK WAS PERFORMED. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK.
SECTION F WAS PROVIDED BY THE USER FACILITY ON A RECEIVED MEDWATCH REPORT. THE MFR'S NAME LISTED IN SECTION F IS INCORRECT, IN FACT THE CORRECT NAME IS LISTED IN SECTION D.3. THE VENTILATOR WAS EVALUATED AT THE USER FACILITY BY A CO REP, THE PRILIMINARY EVAL REVEALED THAT THE PROBLEM WAS CORRECTED BY REINSERTING THE EXPIRATORY PRESSURE TRANSDUCER INTO THE CONNECTOR. THE INVESTIGATION IS ONGOING.
RPTR AWOKE TO THE MOST HARROWING SIGHT HE HAS EVER WITNESSED. BOTH HE AND HIS WIFE HEARD A LOUD POP/CRACK SOUND, HIS WIFE SCREAMED, AND RPTR IMMEDIATELY SAT UP IN THE BED. ALL HE COULD SEE WAS ORANGE, WITH A FLAME COMING FROM HIS WIFE'S LOWER LEFT SHOULDER AND FLAMES POPPING UP ON THE BED EVERYWHERE. RPTR YELLED FOR HER TO "GET OUT OF THE ROOM," ALL THE WHILE BEATING OUT THE FLAMES WITH HIS BARE HANDS. AS IT TURNED OUT THE FIRE WAS COMING FROM THE CONTROL SETTING PANEL OF THE HEATING PAD AS THE COMPONENTS LITERALLY POPPED OUT. RPTR SUSTAINED 2ND DEGREE BURNS TO HIS HANDS, ARMS AND LEGS WHICH LATER DEVELOPED INTO CELLULITIS. HE ALSO SUFFERED DAMAGE TO HIS HOME AND BELONGINGS. HIS WIFE WAS NOT INJURED. (*)
IT IS DIFFICULT TO HANDLE AND MANIPULATE THE CATHETER PRIMARILY DUE TO THE SYMPATHETIC TWIST THAT IS A DIRECT RESULT OF PACKING IN A COIL. THE SYRINGE DOES NOT HAVE A POSITIVE CONNECTION TO THE CATHETER. FREQUENTLY THE SYRINGE COMES OFF OR DISCONNECTS UNEXPECTEDLY WITH UNACCEPTABLE RESULTS. THE VOLUME OF THE SYRINGE IS TOO GREAT FOR ADEQUATE CONTROL OF THE BALLOON. SYRINGE VOLUME=3CC, BALLOON VOLUME=2CC.
IT IS DIFFICULT TO HANDLE AND MANIPULATE THE CATHETER PRIMARILY DUE TO THE SYMPATHETIC TWIST THAT IS A DIRECT RESULT OF PACKING IN A COIL. THE SYRINGE DOES NOT HAVE A POSITIVE CONNECTION TO THE CATHETER. FREQUENTLY THE SYRINGE COMES OFF OR DISCONNECTS UNEXPECTEDLY WITH UNACCEPTABLE RESULTS. THE VOLUME OF THE SYRINGE IS TOO GREAT FOR ADEQUATE CONTROL OF THE BALLOON. SYRINGE VOLUME=3CC, BALLOON VOLUME=2CC. DATE MFG 10/92.
A STONE WAS SUCCESSFULLY ENGAGED IN THE BASKET. UPON REMOVAL THE TIP OF THE BASKET BROKE AND DETACHED IN THE PT'S URETER. AN UNSUCCESSFUL ATTEMPT AT RETRIEVING THE DETACHED SEGMENT FOLLOWED. AN OPEN PROCEDURE WAS PERFORMED FOR SUCCESSFUL REMOVAL OF THE STONE AND DEVICE. THE PT'S CONDITION IS GOOD. NO INFO WAS AVAILABLE REGARDING THE SIZE OF THE STONE ENCAPSULATED IN THE BASKET. CO'S DIRECTIONS FOR USE FOR THIS PRODUCT STATE: "SOME STONES MAY BE TOO LARGE TO BE REMOVED ENDOSCOPICALLY WITH A STONE RETRIEVAL BASKET. TO AVOID STONE IMPACTION, FLUOROSCOPY OR X-RAY SHOULD BE USED TO DETERMINE THE SIZE OF THE STONE; DO NOT USE THE HELICAL BASKET IF THE STONE IS TOO LARGE TO BE REMOVED ENDOSCOPICALLY OR HELD IN THE BASKET."
THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE BASKET WAS DETACHED. THE BASKET DETACHED APPROX. 3MM BELOW THE BASKET BASE CANNULA. THE AREA OF THE BREAK CONSISTED OF SIX INDIVIDUAL WIRES WHICH EVENTUALLY MADE UP THE THREE PAIRED WIRES. MICROSCOPIC EXAMINATION OF THE BROKEN EDGES OF THE WIRES ATTACHED TO THE BASKET INDICATED THE WIRES WERE MELTED TOGETHER. THE WIRES ON THE OTHER END WERE FRAYED, HOWEVER, THE BROKEN EDGES INDICATE CONTACT WITH A HEAT SOURCE. BASED ON THE ENGINEERING EVALUATION, THE MELTED WIRES INDICATE CONTACT WITH A HEAT SOURCE. THEREFORE, WE BELIEVE THE PROCEDURE ITSELF CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE. ALTHOUGH WE DO NOT KNOW THE SOURCE OF HEAT THAT WAS APPLIED TO THE DEVICE, OUR DIRECTIONS FOR USE STATE: "THIS DEVICE SHOULD NOT BE DIRECTLY FIRED UPON BY A PULSED DYE LASER."
IT IS DIFFICULT TO HANDLE AND MANIPULATE THE CATHETER PRIMARILY DUE TO THE SYMPATHETIC TWIST THAT IS A DIRECT RESULT OF PACKING IN A COIL. THE SYRINGE DOES NOT HAVE A POSITIVE CONNECTION TO THE CATHETER. FREQUENTLY THE SYRINGE COMES OFF OR DISCONNECTS UNEXPECTEDLY WITH UNACCEPTABLE RESULTS. THE VOLUME OF THE SYRINGE IS TOO GREAT FOR ADEQUATE CONTROL OF THE BALLOON. SYRINGE VOLUME=3CC, BALLOON VOLUME=2CC. MFG DATE 7/93.
DURING HELICOPTER TRANSPORT, PT DID NOT RECEIVE PRESCRIBED VOLUME OF OXYGEN. DETERMINED THAT DIAPHRAGM IN PEEP ACCESSORY MISSING FROM ASSEMBLY.
OTHER DEVICES USED: TIBIAL TRAY, ARTICULATING SURFACE AND FEMORAL COMPONENT. NO PART NUMBER AND LOT NUMBER AVAILABLE. USER FACILITY INDICATED ON MEDWATCH REPORT DEVICE WAS AVAILABLE FOR EVAL. UPON REQUEST CO WAS DENIED ACCESS OF THE DEVICE. A COMPLETE INVESTIGATION COULD NOT BE CONDUCTED AS NO PRODUCT NUMBER OR LOT NUMBER IS KNOWN AND NO PRODUCT WAS RETURNED. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "N", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? U.
DURING TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT THE OCCLUDER WAS REMOVED. THE COUNTER-OCCLUDER REQUIRED SURGICAL REMOVAL.
INVESTIGATION COULD NOT BE CONDUCTED AS NO LOT NUMBER IS KNOWN AND NO PRODUCT WAS RETRUNED.  SECTION F WAS COMPLETED BY DISTRIBUTOR. CODE #1156-LABELED.  COMPANY ATTEMPTED TO OBTAIN PRODUCT IDENTIFICATION FOR THE SUBJECT MEDWATCH REPORT.  CO COULD NOT OBTAIN A CATALOG NUMBER AND THEREFORE A BASELINE REPORT COULD NOT BE FILED.
PLASTIC COMPONENT SEPARATED FROM METAL COMPONENT.  DEVICE WAS REMOVED AND REPLACED.
INVESZTIGVATION CONDUCTED. DR CITES BONE QUALITY INSUFFICIENT, INFECTION AND POOR ORAL HYGIENE AS CAUSE FOR FAILURE. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
FUSE ON MAIN DISCONNECT ACTIVATED. PT WAS IN THE ICU ON VENTILATOR. PT WAS MANUALLY BAGGED BY RESPIRATORY THERAPIST.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT FROM TEMPORAL PROSTHESIS, BONE QUALITY INSUFFICIENT, INFECTION AND POOR ORAL HYGIENE AS CAUSE FOR FAILURE. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL LOADING OF HEALING ABUTMENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING THE TUNING PROCEDURE FOR THE HAND PIECE, THE UNIT BECAME INOPERATIVE. IT DISPLAYED 5 VOLT FAILURE. A DIFFERENT SURGICAL PROCEDURE WAS PERFORMED.
PUMP WAS IMPLANTED INTO PT W/MS. ISOTOPE STUDY SHOWED PUMP NOT FUNCTIONING.IN OR PUMP FOUND TO BE DEFECTIVE. REPLACED WITH NEW PUMP. PUMP DELIVERING 250 MCG BACLOFEN/DAY AT DISCHARGE. SYMPTOMATICALLY IMPROVED AT TIME OF DISCHARGE. PROBLEM NOT REPORTED FROM OR. DISCOVERED WITH PT COMPLAINT RE: BILLING FOR THE REPEAT PROCEDURE.
DURING PRETREATMENT TESTING, THE MACHINE WOULD NOT GO INTO BYPASS DURING DIALYSATE ALARMS. THE FACILITY MACHINE TECH MANUALLY CREATED THE ALARMS AND THE DIALYSATE STILL DID NOT BYPASS THE DIALYSATE LINES. THE MACHINE WAS NOT USED FOR A TREATMENT. FOLLOWING THE ADVICE OF THE MFR, THE LP430-1 BOARD WAS REPLACED AND APPROPRIATE MACHINE RESPONSE TO DIALYSATE ALARMS WAS VERIFIED. THE BOARD HAS BEEN RETURNED TO THE MFR FOR INVESTIGATION. IF THE INVESTIGATION SHOWS THAT MALFUNCTION OF THIS BOARD COULD HAVE CAUSED OR CONTRIBUTED TO THE MACHINE PROBLEM, A FOLLOW UP REPORT WILL BE SENT.
BLOCK F WAS COMPLETED BY THE MFR. THERE WAS NO PT INVOLVEMENT.
PT WITH UNSTABLE ANGINA WENT FOR L-HEART CATH & CINEARTERIOGRAMS. AT CONCLUSION OF PROCEDURE PORTION OF WIRE INTRODUCER FRACTURED DURING REMOVAL, REMAINING IN THE PT. CAUSED PERFORATION OF R-DEEP FEMORAL ARTERY AND HYPOTENSION REQUIRING TX W/PLASMANATE AND A RADIOLOGIC CONSULT. LARGE HEMATOMA IN PROFUNDA ARTERY AND 3-WIRE INTRODUCER FRAGMENTS WERE NOTED AND SUBSEQUENTLY REMOVED SURGICALLY.
DERMATOME ALLEGEDLY CAUSED A LACERATION AND TOOK A THICK GRAFT ON A THIN SETTING.
DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR UNAVAILABLE. DEVICE WAS NOT RETURNED OFR EVALUAITON AT THE TIME OF THIS REPORT
THE DERMATOME ALLEGEDLY SHREDDED DONOR SKIN WHEN SET AT 0.12.
DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR UNAVAILABLE.
IV TUBING LEAKED BELOW THE FILTER AND WENT ALL OVER THE FLOOR. THE IV WAS RUNNING ON THE PT AT THE TIME.
THE BALLOON OF THIS DEVICE BURST WHILE PERFORMING AN ANGIOPLASTY PROCEDURE. THERE HAS BEEN NO CLAIM OF INJURY RELATED TO THIS EVENT. THE DEVICE IS BEING RETURNED FOR ANALYSIS.
WHILE THIS DEVICE WAS BEING USED IN AN ANGIOPLASTY PROCEDURE, THE BALLOON OF THID DEVICE BURST. THERE HAS BEEN NO CLAIM OF INJURY RELATED TO THIS EVENT. THE DEVICE IS BEING RETURNED FOR ANALYSIS.
DUE TO THE PRESENCE OF DRIED CONTRAST MEDIA IN THE INFLATION LUMEN AND BALLOON OF THE DEVICE, PERFORMANCE TESTING COULD NOT BE PERFORMED.
WHILE THIS DEVICE WAS BEING USED IN AN ANGIOPLASTY PROCEDURE, THE BALLOON OF THIS DEVICE BURST. THERE HAS BEEN NO CLAIM OF INJURY RELATED TO THIS EVENT. THE DEVICE IS BEING RETURNED FOR ANALYSIS.
DUE TO THE PRESENCE OF DRIED CONTRAST MEDICA IN THE INFLATION LUMEN, PERFORMANCE TESTING COULD NOT BE PERFORMED ON THIS DEVICE.
PT HAD OPEN REDUCTION WITH INTERNAL FIXATION IN 1978 FOLLOWING ACCIDENT. INVOLVED LEFT ANKLE. OVER PAST SEVERAL YEARS SCREW HAS BEEN WORKING ITSELF OUT. DID DEVELOP ABSCESS WHICH WAS HEALED. NOW REQUIRES SCREW REMOVAL TO PREVENT FURTHER ABSCESS. SCREW REMOVED ON 7/29/96.
BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMIES WAS REPORTED.
MASTOPEXY WITH EXCHANGE OF BILATERAL BREAST IMPLANTS WAS REPORTED.
PT WITH LEFT HIP PROSTHESIS NEEDED REVISION IN 1995. NOW NEEDS RIGHT HIP PROSTHESIS REVISION DUE TO LOOSENING OF ACETABULAR COMPONENT. PROSTHESIS WAS PLACED IN 1985. SURGEON GAVE PROSTHESIS TO PT AND WAS UNABLE TO DETERMINE MFR.
A 5MM DIAMETER 20CM LENGTH BALLOON CATHETER WAS PASSED ACROSS THE LESION DURING LEFT COMMON ILIAC ARTERY BALLOON ANGIOPLASTY WITH PLACEMENT OF ANOTHER CO'S 6MM STENT, POSITION CONFIRMED, BUT BALLOON RUPTURED. A SECOND BALLOON CATHETER WAS PASSED SUCCESSFULLY. LATER IN THE DAY FILMS SHOWED APPARENT EMBOLUS AT THE LEVEL OF THE KNEE JOINT. FURTHER SURGERY REVEALED THIS TO BE A PORTION OF THE BALLOON CATHETER MEASURING 2 TO 2.5CM.
A 22 GAUGE CATHETER WAS SUCCESSFULLY INSERTED BY THE RN. ON THE SECOND ATTEMPT THE PT COMPLAINED OF FEELING WARM. HE BECAME DIAPHORETIC AND PALE. THE RN INSTRUCTED THE PT TO LOWER HIS HEAD. THE PT LOST CONSCIOUSNESS AND THE RN PLACED HIM ON THE FLOOR TO MAINTAIN AN OPEN AIRWAY. STAFF CALLED 911 AND RN REMAINED WITH THE PT. THE RN CHECKED THE PT'S PULSE AND RESPIRATIONS AND THEY WERE NOT PRESENT. RN REMOVED THE CATHETER WHEN PT LOST CONSCIOUSNESS AND PROCEEDED TO INITIATE CPR PROTOCOL. PT SELF REVIVED AS THE RN BEGAN CPR. THE PT WAS RESPONDING APPROPRIATELY UP UNTIL HE WAS TRANSPORTED TO THE HOSP BY THE AMBULANCE.
PACEMAKER LEAD FRACTURE (LEAD PUT IN 5/27/95) LEAD REPLACED ON 6/20/96. (*)
SYRINGES WERE IN A NEW SEALED BOX. TWO OF THE SYRINGES HAD A RED SUBSTANCE IN THEM. RPTR CALLED THE MFR AND SENT THE SYRINGES BACK. RPTR RECEIVED A LETTER FROM THE MFR STATING THAT THE RED SUBSTANCE WAS BLOOD. IT IS NOT THE RPTR'S BLOOD. THE NEEDLES WERE NEW AND JUST TAKEN OUT OF THE SEALED PACKAGE. RPTR NEVER USED THE SYRINGES. THE FACT THAT THERE IS BLOOD IN A NEW SYRINGE CONCERNS RPTR.
A 57-YR-OLD MALE, FOUND PULSELESS AND APENIC IN A DIALYSIS CLINIC. WHEN ENGINE CO ATTEMPTED TO REMOVE THE BACKING ON THE DEFIBRILLATION ELECTRODES THEY WERE UNABLE TO DO SO. THE ENGINE CO USED THE CLINIC'S DEFIBRILLATOR TO DEFIBRILLATE PULSELESS V-TACH. THE ENGINE CO ATTEMPTED TO REMOVE THE PAD BACKING AGAIN AFTER THE CALL WITHOUT SUCCESS. THERE WAS A 30 SECOND TO ONE MIN DELAY IN PT DEFIBRILLATION AND AT THIS TIME PT'S OUTCOME IS UNKNOWN.
A JUGULAR APPROACH WAS USED TO INSERT A VENA CAVA FILTER. THE PACKAGING STATED 12FR JUGULAR INTRODUCER. AFTER INSERTING AND DEPLOYING THE FILTER IT WAS OBSERVED TO BE INVERTED.
PT IS AN IDDM WHO MONITORS GLUCOSE WITH A METER BID. METER WAS CALIBRATED AT CLINIC. REAGENT STRIP READINGS OVER 1 MONTH PERIOD WERE 90 TO 145. PT SUBSEQUENTLY REDUCED INSULIN FROM HUMULIN N 20U AM AND 30U IN PM TO NO INSULIN. IT WAS DISCOVERED ON A ROUTINE VISIT THAT ACTUAL BLOOD SUGAR WAS 220. THESE FALSE READINGS COULD HAVE RESULTED IN SEVERE KETOACIDOSIS OR DEATH. THIS IS THE ONLY REAGENT STRIP WHICH THE INSURANCE CO WILL PAY FOR.
PT'S WIFE CALLED AND STATES HUSBAND WAS LOADING THINGS INTO THE GARAGE SALE AND JUST COLLAPSED IN SUDDEN DEATH. THEY WERE UNABLE TO REVIVE HIM. CORONER WROTE DOWN MYOCARDIAL INFARCTION AS CAUSE OF DEATH POSSIBLY DUE TO A HEART VALVE. NO AUTOPSY WAS PERFORMED.
ON THE CAM RAMP ASSEMBLY, THE ROLL PIN KEEPS FALLING OUT CAUSING THE SPRING, THE PROTECTIVE CAP, AND THE CENTER LATCH TO FALL OFF AND GET LOST. THIS PREVENTS THE TABLE FROM LOCKING INTO PLACE.
THE PROBE COVERS ARE USED FOR INTRAVAGINAL OR PELVIC ULTRASOUNDS. THE COVERS ARE BREAKING DURING PROCEDURES WHICH IS CAUSING UNSAFE CONDITIONS FOR THE PTS BECAUSE THE PROBE IS BECOMING CONTAMINATED.
WHILE PERFORMING THE MFR'S RECOMMENDED QUARTERLY TEST ON DEVICE BATTERIES, FOUR OUT OF SIX FAILED THE MFR'S BATTERY CAPACITY TEST. AFTER CONTACTING THE MFR THEY PROMPTLY SHIPPED A NEW BATTERY. AFTER TESTING THE NEW BATTERIES USING THE MFR SUGGESTED TEST, TWO OUT OF FOUR REPLACEMENT BATTERIES WERE REPLACED DUE TO FAILURE OF THE BATTERY CAPACITY TEST. THE MFR CONTINUES TO PROVIDE NEW BATTERIES WHEN FACILITY HAS THIS PROBLEM.
THE NEEDLE DRIVERS AND HEMOSTATS IN THE LACERATION TRAY DO NOT HAVE SUFFICIENT GRIP STRENGTH AND ARE MECHANICALLY UNRELIABLE. A PT WITH A LACERATION TO A JOINT CAPSULE COULD NOT HAVE HIS LACERATION CLOSED BECAUSE THE STRENGTH OF THE NEEDLE DRIVER WOULD NOT ALLOW THE NEEDLE TO BE PUSHED THROUGH THE CAPSULE. THIS MEANT THAT THE PT HAD TO BE ADMITTED TO THE HOSP AND SCHEDULED FOR SURGERY WHEN HE SHOULD HAVE BEEN TAKEN CARE OF IN THE CLINIC WITH THE PROCUCT. SEVERAL OTHER INSTANCES HAVE OCCURRED WHERE OTHER INSTRUMENTS HAD TO BE USED TO COMPLETE THE TASK.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT REMOVAL. THEREWAS NO PT INJURY OR MEDICAL INTERVENTION.
THE MES (MEDICAL EQUIPMENT SERVICE) TECH REPLACED UF PUMP THERMAL FUSE. MACHINE CONTINUED TO FAIL THE AUTOTEST. MES THEN REPLACED THE PUMP. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. CO TRACE NUMBER OF RETURNED COMPONENT/ASSEMBLY (WHEN APPLICABLE): 223087000 A. A REVIEW OF DTF HISTORY DOES NOT APPLY. A REVIEW OF CPF HISTORY FOR SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO FIELD. A SECONDARY SEARCH OF DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE SINCE THE TRACEABILITY DOES NOT INCLUDE A LOT NUMBER OR DATE. THE RETURNED PUMP THERMAL FUSE WAS EXAMINE. FUSE WAS CONNECTED TO AN OHM METER AND THE METER SHOWED 0.0 OHMS. THIS INDICATES THAT FUSE IS OKAY. THE FUSE WAS DISASSEMBLED. THERE WAS NO SIGN THAT THE WAX INSIDE THE FUSE HAD MELTED PREVIOUSLY. THERE WAS NO PROBLEM WITH THERMAL FUSE THAT WAS REPLACED BY THE MES TECH. THE UF PUMP WAS INSTALLED INTO A CALIBRATED LAB MACHINE. UNCALIBRATED STROKE VOLUME OF THE UF PUMP AFTER A ONE HR PERIOD WAS 100.7 ML. AT THIS TIME THE MACHINE PASSED AUTOTEST. AFTER RUNNING 49 MORE HOURS THE UNCALIBRATED STROKE VOLUME OF THE PUMP WAS CHECKED AND MEASURED AT 100.5 ML. THE CHANGE OF 0.2 ML IS NOT SIGNIFICANT TO THIS INVESTIGATION AND CAN BE ATTRIBUTED TO THERMAL EXPANSION OF THE PUMP STROKE AFTER 50 HRS OF OPERATION. THE MACHINE PASSED AUTOTEST ONE AGAIN AT THIS TIME. PUMP THEREFORE MET MFG REQUIREMENTS. THE COMPLAINT CONDITION PUMP THERMAL FUSE FAILURE OR UF PUMP FAILURE COULD NOT BE CONFIRMED. THE PUMP PERFORMED WITHOUT FAILURE FOR 50 HRS. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N. REPORT ATTACHED? N.
WHILE THIS DEVICE WAS BEING USED IN AN ANGIOPLASTY PROCEDURE, THE BALLOON OF THIS DEVICE BURST AT A PRESSURE BELOW ITS RATE BURST PRESSURE.
ANALYSIS OF THIS DEVICE REVEALED A PINHOLE IN THE DISTAL END OF THE BALLOON'S WORKING AREA. REVIEW OF THIS DEVICE'S DHR DID NOT REVEAL ANY RELATED OBSERVATIONS.
PT DID NOT FOLLOW PROPER USAGE INSTRUCTIONS PROVIDED IN HER PACKAGE INSERT. PT FORCED HER VANCERIL INHALER MOUTHPIECE CAP ONTO MOUTHPIECE SECTION AND SUPPOSEDLY RUPTURED THE SCREEN GRID. THEN THE PT TRIED TO INHALE THEIR VANCERIL MEDICATION THRU CO ATTACHED MICROSPACER PRODUCT, SHE INHALED PART OF THE RUPTURED PLASTIC SCREEN'S GRID. NO INJURIES WERE SUSTAINED. NO PROOF OF HOSP RECORDS OR THE DAMAGED DEVICE WERE AVAILABLE FOR EVALUATION.
THE BALLOON OF THIS DEVICE BURST DURING AN ANGIOPLASTY PROCEDURE. THERE HAS BEEN NO CLAIM OF INJURY RELATED TO THIS EVENT.
DEVICE INFLATED TO RATED FOR 3 MIN WITH NO LEAKS OBSERVED.
CLIENT ON O2 CONCENTRATOR HAS TOLD DIFFERING STORIES: INITIALLY STATED HIS O2 CONCENTRATOR BLEW UP. THEN STATED HE THOUGHT IT HAD BEEN LIT BY LIGHTENING DURING STORMS THE PREVIOUS NIGHT. THEN CHANGED HIS STORY TO SAY IT NEVER BLEW UP, BUT THAT HE HAD BEEN SLEEPING IN HIS CHAIR AND WAS AWAKENED AS HE SLIPPED OUT OF HIS CHAIR INTO A FIREBALL THT WAS NEAR HIS FACE AND SUSPENDED OFF THE FLOOR. CLIENT STATES THIS IS WHAT BURNED HIS FACE AND THE BURN TO HIS HAND OCCURRED WHEN HE ATTEMPTED TO REMOVE HIS GLASSES. WAS TREATED AND RELEASED WITH 1ST DEGREE BURNS FROM THE OUTPATIENT CLINIC. HE DENIES SMOKING BUT HAS SMOKED IN THE PAST, AND HIS HOUSE SMELLS OF SMOKE ON OCCASION, THOUGH HE ALWAYS DENIES SAME. NOBODY WAS HOME WITH HIM AT THE TIME OF THE INCIDENT. ALSO, HIS FINAL STORY WAS THAT HE FELT THIS WAS SPONTANEOUS COMBUSTION.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT REMOVEAL. PT UNDERWENT AN UNSCHEDULED TREATMENT TO REMOVE THE WEIGHT.
THE MES (MEDICAL EQUIPMENT SERVICE) TECH REPLACED THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE. THE MACHINE CONTINUED TO FAIL THE AUTOTEST. THE MES THEN REPLACED THE UF PUMP. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. CO TRACE NUMBER OF RETURNED COMPONENT/ASSEMBLY (WHEN APPLICABLE): 223087000A.  A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THE COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE SINCE THE TRACEABILITY DOES NOT INCLUDE A LOT NUMBER OR DATE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE RETURNED UF PUMP THERMAL FUSE WAS EXAMINED. THE FUSE WAS CONNECTED TO AN OHM METER AND THE METER SHOWED 0.0 OHMS. THIS INDICATES THAT THE THERMAL FUSE IS OKAY. THE FUSE WAS DISASSEMBLED. THERE WAS NO SIGN THAT THE WAX INSIDE THE FUSE HAD MELTED PREVIOUSLY. THERE WAS NO PROBLEM FOUND WITH THE THERMAL FUSE THAT WAS REPLACED BY THE MES TECH. THE UF PUMP WAS INSTALLED INTO A CALIBRATED LAB MACHINE. THE UNCALIBRATED STROKE VOLUME OF THE UF PUMP AFTER A ONE HR PERIOD WAS 100.7 ML. AT THIS TIME MACHINE PASSED AUTOTEST. AFTER RUNNING 49 MORE HRS, THE UNCALIBRATED STROKE VOLUME OF THE PUMP WAS CHECKED AND MEASURED AT 100.5 ML. THE CHANGE OF 0.2 ML IS NOT SIGNIFICANT TO THIS INVESTIGATION AND CAN BE ATTRIBUTED TO THERMAL EXPANSION OF THE PUMP STROKE AFTER 50 HRS OF OPERATION. THE MACHINE PASSED AUTOTEST ONCE AGAIN AT THIS TIME. THE PUMP THEREFORE MET MFG REQUIREMENTS. THE THERMAL FUSE FROM THE UF PUMP WAS REMOVED AND CONNECTED TO AN OHM METER. SINCE THE UF PUMP RAN THE EQUIVALENT OF 12 PT RUNS IN A ROW WITHOUT A PROBLEM BEING IDENTIFIED AND PASSED AUTOTEST, IT IS CONCLUDED THAT THE UF PUMP AND THE THERMAL FUSE DID NOT CAUSE THE REPORTED CONDITION IN THIS REPORT. THIS TEST WITH 12 SIMULATED PT RUNS CONSTITUTES THE EXTRA MECHANICAL RECYCLING AND STRESS TEMPERATE INCREASES PORTION OF THE PROCEDURE REQUIREMENTS (COLD EXPOSURE WOULD NOT AFFECT PUMP PERFORMANCE). ON THE CUSTOMER ENGINEERING ACTION REPORT, IT WAS NOTED THAT THE 12-PIN CONNECTOR WAS REPLACED AT THE SAME TIME AS THE UF PUMP AND THE UF PUMP THERMAL FUSE. IT IS POSSIBLE THAT THE CONNECTOR WAS RESPONSIBLE FOR THE PROBLEM. IF THE CONNECTOR HAD AN OPEN OR INTERMITTENT CONNECTION FOR THE UF PUMP, THE PUMP WOULD NOT OPERATE AND THE PT WOULD EXPERIENCE INSUFFICIENT WEIGHT LOSS. TE 12-PIN CONNECTOR WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE COMPLAINT HISTORY FOR THIS MACHINE ON 8/27/96 SHOWS THAT THERE HAVE BEEN NO FURTHER OCCURRENCES OF THIS NATURE, INDICATING THAT THE COMPLAINT CONDITION WAS CORRECTED BY THE ACTIONS TAKEN. IT IS RECOMMENDED IN THE CO'S OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY. CUSTOMER CONTACTED: N. SALES/SEVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N. REPORT ATTACHED? N.
RIGHT BREAST IMPLANT WAS LEAKING SALINE AND HAD LOST APPROX 150CC OF SALINE SINCE IMPLANT DATE.
BILATERAL RUPTURED BREAST IMPLANTS. ALSO BILATERAL BREAST ASYMMETRY.
FOLLOWING BALLOON DILATATION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THERE WAS CONSIDERABLE DIFFICULTY NOTED IN AN ATTEMPT TO WITHDRAW THE BALLOON CATHETER. FURTHER EXAMINATION SHOWED THAT CATHETER TIP AND BALLOON HAD BROKEN OFF IN THE VESSEL. THE PT WAS TRANSFERRED TO THE OR WHERE THE FRAGMENT WAS REMOVED SURGICALLY.
CUSTOMER WAS USING THE BALLOON WITHIN AN INTERNAL MAMMARY ARTERY LESION, IT DID NOT HOLD PRESSURE AT 5 ATMOSPHERES. ANOTHER BALLOON WAS UTILIZED, HOWEVER, UNABLE TO CROSS THE LESION. THE PT'S CONDITION IS REPORTED AS WELL.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAM: TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE BALLOON AND INFLATION LUMEN. FUNCTIONAL TESTING: THE BALLOON WAS PRESSURIZED WITH WATER, WHICH REVEALED THE PRESENCE OF A PINHOLE-TYPE LEAK SOURCE, 0.4 CM PROXIMAL TO THE DISTAL BALLOON SEAL. THIS IS THE AREA OPPOSITE THE CURVED FRACTURED COREWIRE END. MICROSCOPIC EXAM: LIGHT OPTICAL EXAM REVEALED THE COREWIRE WITHIN THE BALLOON WAS FRACTURED. FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) ON BOTH THE FRACTURED COREWIRE ENDS AND THE BALLOON PINHOLE AREA REVEALED EVIDENCE OF HAVING FRACTURED DUE TO A TORSIONAL OVERLOAD. IT IS SUSPECTED THAT THE DISTAL CORE WIRE FRACTURED END PIERCED THROUGH THE BALLOON WALL, CREATING THE PINHOLE AS A RESULT OF OVERTORQUING DURING USE.
EMPTY 500ML CONTAINER WAS FILLED WITH NS AND UNASYN. UPON CHECKING BAG A LEAK WAS DETECTED AT THE PORT WHERE IT IS SUPPOSED TO BE SEALED AT THE INJECTION SITE.
PT HAD A PENILE PROSTHESIS INSERTED ON 11/17/92. ON 8/13/96, PT SAYS HE COULD NOT INFLATE THE PROSTHESIS. HE CAME IN TO SEE THE DR WHO ALSO TRIED TO INFLATE IT, WITH NO SUCCESS. THE DR INFORMED HIM THAT THE PROSTHESIS HAD FAILED. THE PROSTHESIS HAS TWO CYLINDERS, ONE INSERTED IN EACH SIDE OF THE PENIS. THE TIP OF THE PENIS IS SQUEEZED TO INFLATE THE PROSTHESIS.
X-TUBE ASSM 16" X 16". DEALER ALLEGES X-TUBE BROKE AT BOTTOM LEFT.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT HAS BEEN USING THIS MFR'S INSULIN SYRINGES FOR ABOUT SIX YEARS. OCCASIONALLY DURING THIS PERIOD SMALL PIECES OF WHITE FOREIGN MATERIAL WERE NOTICED ADHERING TO THE NEEDLES. SOME PIECES WERE LARGE, OTHERS SMALL. ON OTHER OCCASIONS A SYRINGE WAS FOUND WITH THE NEEDLE STICKING THROUGH THE CAP, OR PART OF THE CAP STUCK TO THE NEEDLE. PT IS AN ADULT.
USER LOST HER BALANCE FELL AND HIT HER HEAD ON THE EDGE THE WALKER'S FOLDING MECHANISM. USER RECEIVED 35 STITCHES ON RIGHT SIDE OF FOREHEAD.
EVENT FREQUENCY & SEVERITY. IS FREQUENCY OF OCCURANCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURANCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
COTTON BARRIER BETWEEN SWAB AND MEDIA ATTACHED TO THE THROAT SWAB. WHEN THE SWAB WAS USED, THE COTTON BARRIER DETACHED AND BECAME LODGED IN THE CHILD'S THROAT. PHYSICIAN PERFORMED A FINGER SWIPE OF THE AREA TO PREVENT CHOKING.
TUBING LEAK CAUSED BLOOD TO LEAK OUT AND PRESENT POSSIBLE EXPOSURE. REPORTED TO MFR. MFR TO ISSUE A RECALL ON LOTS. MFR IS CHECKING THE OTHER LOTS USER REPORTED AND WILL LET RPTR KNOW WHETHER THEY ARE JUST SPORADIC OCCURRENCES.
OR AXLE WITH NUT. CUSTOMER ALLEGES THE RETAINING BALLS FELL OUT OF THE AXLES.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL.
IN DEPLOYING A CORONARY STENT IN THE PROXIMAL LAD THE BALLOON WAS INFLATED TO THE APPROPRIATE ATMOSPHERIC PRESSURE. AFTER DEPLOYMENT THE BALLOON WOULD NOT DEFLATE. SEVERAL ATTEMPTS WERE MADE WITH DIFFERENT INFLATION DEVICES AND SYRINGES WITH NEGATIVE PRESSURE. ALL ATTEMPTS WERE UNSUCCESSFUL. THE PT WAS EXPERIENCING SEVERE CHEST PAIN, ACUTE ST ELEVATIONS ON ECG AND BECOMING UNSTABLE. DECISION WAS MADE TO RUPTURE THE BALLOON USING INCREASED PRESSURE. AT 25 ATM THE BALLOON PARTIALLY RUPTURED. ANOTHER INFLATION TO 25 ATM WAS DONE WITH COMPLETE RUPTURE OBTAINED AND THE BALLOON WAS REMOVED. THE ECG CHANGES AND CHEST PAIN RESOLVED SHORTLY THEREAFTER.
MARKING BANDS ON ANGIOGRAPHIC CATHETER STRIPPED OFF DURING CATHETER REMOVAL. BANDS WERE IN COMMON FEMORAL ARTERY AND WERE MANEUVERED TO RIGHT ILIO - LUMBAR ARTERY FOR "PARKING."
REAR ARMREST RECEIVER P2, 1/4-28 X 1 HEX CS, 1/4 AN WASHER FLAT THIN. END USER ALLEGES HE "LEANED ON HIS ARMREST AND THE ARM GAVE WAY. HE CAUGHT HIMSELF AND PREVENTED FALLING OUT OF THE CHAIR BY GRABBING THE JOYSTICK."
PT'S PICC LINE WAS PLACED 7/22/96 AT THE HOSP. WAS FLUSHING VERY SLUGGISHLY AND WITH SOME PRESSURE NEEDED TO FLUSH. ATTEMPTED TO FLUSH WITH UROKINASE TWICE BUT WAS UNSUCCESSFUL. LINE WAS PULLED ON 7/25/96 BECAUSE IT WOULD NO LONGER FLUSH AND WAS NON-FUNCTIONAL. CXR INDICATED CATHETER WAS INTACT AND IN CORRECT PLACEMENT.
A FILTER DID NOT OPEN AFTER DEPLOYMENT. A SECOND FILTER WAS SUCCESSFULLY PLACED WITH NO PT COMPLICATIONS. A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO VENA CAVA FILTER INSERTION. "THIS PROCEDURE DETERMINES CAVAL PATENCY AND DIAMETER AND IS USED TO EVALUATE THE INFERIOR VENA CAVA FOR THE PRESENCE OF THROMBUS AND CONGENITAL ANOMALIES. DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER. IN MOST CASES, A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE. THE INTRODUCER CATHETER MUST BE FLUSHED THROUGH THE FLUSH PORT BY FREQUENT INJECTION OR CONTINUOUS INFUSION OF STERILE HEPARINIZED SALINE DURING THE IMPLANT PROCEDURE. INSUFFICIENT FLUSHING CAN ALLOW THROMBUS FORMATION INSIDE THE VENA CAVA FILTER WHICH CAN BIND THE LEGS AND PREVENT COMPLETE OPENING UPON RELEASE."
CASTER HINGE L AND R REVOLUTION. CASTER HINGE SCREWS PULLED OUT.
THREAD ENGAGEMENT LENGTH INADEQUATE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
HYPERGLYCEMIA: A MAN REPORTED THAT HIS WIFE EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS IN 6/96 WHEN USING DEVICE, NEEDLES AND NOVOLIN 70/30 (RDNA) PENFILL CARTRIDGES AND WAS HOSPITALIZED FOR ONE WEEK. HE REPORTED THAT THE PUSHBUTTON ON THE DEVICE WAS NOT WORKING PROPERLY AND THAT THE DEVICE WAS NOT DELIVERING THE CORRECT AMOUNT OF INSULIN. THE HUSBAND ADMINISTERS THE INJECTIONS TO HIS WIFE BECAUSE SHE IS BLIND. ANALYSIS RESULTS OF DEVICE IN QUESTION: TECHNICAL DESCRIPTION 1) DAMAGED DRIVE JAW SLEEVE DUE TO MISUSE. JAW LOCK COLLAR NOT TURNED IN LOCKED POSITION BEFORE PUSHBUTTON WAS DEPRESSED. MEDICAL CONSEQUENCES: NO INSULIN ADMINISTRATION POSSIBLE, BUT THE DEFECT IS VISIBLE.
STIMULATOR FAILED TO STIMULATE IN 3/95. WAS CHECKED OUT BY CO REP AND NEUROSURGEON ON SEVERAL DATES. THEY COULDN'T SEE ANY BROKEN LEADS ON X-RAY SO THEY SAID RPTR WOULD HAVE TO HAVE SURGERY AND REPLACE IT. THE NEUROSURGEON RECOMMENDED RPTR HAVE A LIVING WILL MADE BEFORE HAVING IT DONE. THE NEUROSURGEON THAT REPAIRED RPTR'S RUPTURED DISC SAID HE HAS NEVER SEEN A STIMULATOR PUT ON UPPER BACK AND THAT PT NEVER NEEDED IT ANYWAY, HE JUST NEEDED THE RUPTURED DISC CORRECTED.
PART OF OVERHEAD TRAPEZE FELL ONTO PT'S LEFT CHEST WHILE IN USE. CLAMPS AT EACH END OF THE OVERHEAD DOUBLE CLAMP BAR, NOTED TO BE BROKEN. NO INJURY TO PT.
A BALLOON RUPTURED AT 6 ATMS DURING A SUPERFICIAL FEMORAL ANGIOPLASTY OF A HIGHLY CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. SINCE FOLLOW UP INDICATED THIS BALLOON WAS USED IN A HIGHLY CALCIFIED LESION CO BELIEVES THIS FACTOR CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE PRODUCT CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.UTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. SINCE OUR FOLLOW UP INDICATED THIS BALLOON WAS USED IN A HIGHLY CALCIFIED LESION WE BELIEVE THIS FACTOR CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING TEH PRODUCT WE CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
DURING MORNING CHECK, THE DEVICE REPORTEDLY WILL NOT TURN ON WITH A FULLY CHARGED AND NEW BATTERY. PER NOTE RECEIVED WITH THE DEVICE ON 8/9/96, THE DEVICE WILL POWER ON PRESSING THE "SHOCK" AND "MARK EVENT" BUTTONS AT THE SAME TIME.
DEVICE EVALUATION SUMMARY: THE REPORTED COMPLAINT WAS VERIFIED. THE "ON" SWITCH ON THE KEYBOARD ASSEMBLY WAS FOUND TO BE OPEN. ALSO, CORROSION WAS OBSERVED ON SOME OTHER SWITCHES. THE KEYBOARD ASSEMBLY WAS REPLACED, AND PROPER OPERATION OF THE DEVICE WAS VERIFIED.
CASTER HINGE R & L RV AND 1/4-28 X 1.625 BH C/S. DEALER ALLEGES THE FRONT MOUNT CASTER BRACKET SCREWS KEEP FALLING OFF.
THREAD ENGAGEMENT INADEQUATE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE DSREPORTABLE EVENT.
IN 1977 PT HAD L MODIFIED RADICAL MASTECTOMY WITH RECONSTRUCTION IN 1978 AND 1983. HER RECONSTRUCTION INVOLVED A DOUBLE LUMEN SALINE-SILICONE IMPLANT. OVER THE LAST YR PT HAS NOTICED L BREAST GETTING SMALLER, BECOMING EXTREMELY HARD AND PAINFUL AND LIMITING MOTION OF L ARM AND SHOULDER. NO EVIDENCE OF RECURRENCE OF CANCER. PHYSICAL EXAM REVEALS BAKER'S 4 CAPSULAR CONTRACTURE WITH TENDERNESS.
X-TUBE ASSM 17" X 18". DEALER ALLEGES THE X-TUBE BROKE AT THE CENTER HOLE.
HIGH STRESS FACTOR AT CTR OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT RECEIVED LEG BURN FROM CAUTERY PENCIL. STAFF BELIEVED THE CAUTERY WAS IN ACTIVATION STATE WHEN PLUGGED INTO GENERATOR.
ON 8/13/96 OTHER MFR WAS CONTACTED IN WRITING REQUESTING FULL INVESTIGATION AND REPORT OF EVALUATION.
ON 8/13/96 MFR WAS CONTACTED IN WRITING REQUESTING FULL INVESTIGATION AND REPORT OF EVALUATION.
THE CLAMP SCISSORED WHILE ON THE PT'S AORTA. THE PHYSICIAN PLACED ANOTHER CLAMP ON THE AORTA BEHIND THE BROKEN ONE AND THEN REMOVED THE BROKEN CLAMP. NO PT INJURY WAS REPORTED AS A RESULT OF THIS EVENT.
MFG PROCESS MODIFIED FOR BOXLOCK CHANGE AND MODIFICATION TO HEAT TREATMENT CYCLE. OBSERVED INSTRUMENT TO BE BROKEN ON THE MALE HALF OF THE BOXLOCK AREA. ALSO NOTED PRODUCT WAS PRODUCED WITH THE OLD DESIGN. EN20556 HAS SINCE BEEN IMPLEMENTED THAT MADE MODIFICATIONS TO THE DESIGN OF THE INSTRUMENT WHICH SHOULD MINIMIZE THIS TYPE OF COMPLAINT. A COMPLAINT HISTORY REVIEW WAS PERFORMED FROM 11/92-8/96 AND FOUND NO SIMILAR COMPLAINTS ON PRODUCT PRODUCED AFTER THE EN CHANGE.
THE DR WAS USING THE CAUTERY DEEP WITHIN THE POCKET FOR THE BREAST IMPLANT. THE HANDPIECE ARCED AT THE CONNECTION BETWEEN THE ELECTRODE AND THE HANDPIECE PRODUCING A BURN.
X-TUBE ASSM 16" X 16". DEALER ALLEGES X-TUBE IS BROKE AT THE CENTER BOLT HOLE ON TUBE.
HIGH STRESS FACTOR AT CTR OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIEDESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ALARMS ON BEDSIDE MONITORING EQUIPMENT FOUND OFF AND PT HAD AN OXYGEN SATURATION OF 40%.
X-TUBE ASSM 19" X 15". DEALER ALLEGES X-TUBE BROKE AT THE SEAT RALL AND X-TUBE WELD. THE END CUSTOMER CLAIMS SHE DID NOT INJURE HERSELF.
HIGH STRESS FACTOR AT END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TIP OF THE FORCEPS BROKE WHILE PASSING THROUGH CANNULA. BOWEL PERFORATED NEAR THE GALL BLADDER. BROKEN PIECE WAS RETRIEVED, BOWEL REPAIRED, PROCEDURE COMPLETED. ACCORDING TO THE HOSP THE SUBJECT INSTRUMENT WAS PURCHASED IN 1990. ONCE THE WARRANTY EXPIRES, THEY HAVE A CO TO SVC THEIR INSTRUMENTS. AFTER THE INCIDENT, THE SUBJECT INSTRUMENT WAS SENT TO SVC CO FOR EVALUATION. SVC CO DETERMINED THE PHYSICIAN USED UNDUE FORCE PUTTING THE INSTRUMENT THROUGH THE CANNULA AND CAUSED THE BREAKAGE OF THE INSTRUMENT AND INJURY TO THE PT. THE FORCEPS WAS REPAIRED AND RETURNED TO THE HOSP.
BREAST IMPLANTS IN 1982. COMPLAINED OF PAIN, DISCOMFORT, FATIGUE, MALAISE AND GENERALIZED DETERIORATING HEALTH. RIGHT AND LEFT IMPLANTS WERE LEAKING AND EXPLANTED.
X-TUBE ASSM 18" X 16". DEALER ALLEGES X-TUBE BROKE AT CENTER BOLT HOLE.
HIGH STRESS FACTOR AT CENTER OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. ORO THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OT THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THREE HRS INTO HEMODIALYSIS TREATMENT PT EXPERIENCED CARDIAC ARREST AND DIED. PT DIALYZING ON ZERO POTASSIUM BATH. LAST SERUM POTASSIUM LEVEL WAS 4.6 ON 8/10/96. DIALYSIS MACHINE WAS INSPECTED. DIALYSATE FLOW RATE WAS 700 CC/MIN. BLOOD FLOW RATE AT 200 CC/MIN. EQUALS 310 CC/MIN. ONE WEEK LATER THIS SAME MACHINE INVOLVED WITH ANOTHER CARDIAC ARREST AND DEATH. MFR WAS ASKED TO CHECK MACHINE. MFR FOUND DIALYSATE FLOW TO BE 875 CC/MIN. MDR WAS ALSO FILED BY MFR.
LEFT BREAST IMPLANT WAS REMOVED. PT COMPLAINED OF PAIN IN LEFT SHOULDER. IMPLANTED IN THE LATE 70'S.
IMPLANTS PLACED IN 1977. PT COMPLAINED OF JOINT PAIN, MEMORY LOSS, MYALGIAS, FATIGUE, AND NIGHT SWEATS.
X-TUBE ASSM 16" X 16". DEALER ALLEGES X-TUBE BROKE AT CENTER BOLT HOLE.
HIGH STRESS FACTOR AT CENTER OF X-TUBE. THIS REPORT OR OTHER SUBMITTED BY QUICKIE DESIGNS, INC. UNCER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNAS, INC. ORO THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
BREAST IMPLANTS 18 YEARS OF AGE. PT NOW COMPLAINS OF HARDNESS AND FIRMNESS BOTH BREASTS, PAIN AND DISCOMFORT BOTH BREASTS AND RUPTURING OF LEFT IMPLANT.
IMPLANTS WERE PLACED IN 1986. PT COMPLAINED OF PAIN, FATIGUE.
BREAST IMPLANTS 18 YEARS AGO. PT NOW COMPLAINS OF BREAST PAIN AND DISCOMFORT BOTH BREASTS.
DURING A THORACENTESIS PROCEDURE, M.D. NOTED THAT A PIECE OF THORACENTESIS CATHETER SHEARED OFF WHILE HE WAS ATTEMPTING TO REMOVE IT FROM THE PLEURAL CAVITY. THE PT WENT TO RADIOLOGY FOR FLUOROSCOPY FOR RETRIEVAL OF THE SHEARED OFF PIECE OF CATHETER. A 4 INCH PIECE OF CATHETER WAS SUCCESSFULLY REMOVED.
BILATERAL IMPLANTATION WAS ON 5/14/82 WITH EXPLANT OF THE RIGHT IMPLANT ON 2/20/92 AND 10/29/86 OF THE LEFT IMPLANT. PLAINTIFF ALLEGES VARIOUS SYMPTOMS INCLUDING, BUT NOT LIMITED TO, NIGHT SWEATS, ARTHRALGIAS, MYALGIAS, AND CHRONIC FATIGUE.
CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
THE JAW FRACTURED OFF OF THE CLAMP WHILE IT WAS CLAMPED ON THE PT'S AORTA. THE CLAMP WAS REPLACED WITH ANOTHER AND NO PT INJURY OCCURRED AS A RESULT OF THE BROKEN CLAMP.
MFG PROCESS MODIFIED FOR BOXLOCK CHANGE AND MODIFICATION TO HEAT TREATMENT CYCLE. OBSERVED INSTRUMENT TO BE BROKEN AT THE MALE HALF OF THE INSTRUMENT. ALSO NOTED PRODUCT WAS PRODUCED WITH THE OLD DESIGN. SINCE THE MFR OF THIS INSTRUMENT, EN20556 HAS BEEN IMPLEMENTED WHICH SHOULD MINIMIZE THIS TYPE OF COMPLAINT. A COMPLAINT HISTORY REVIEW WAS PERFORMED FROM 11/92 - 8/96, AND FOUND NO SIMILAR COMPLAINTS FOR PRODUCT AFTER THE EN.
INITIAL BILATERAL IMPLANTATION WAS ON 12/14/81 WITH REPLACEMENT ON 5/14/82. PLAINTIFF ALLEGES VARIOUS SYMPTOMS INCLUDING, BUT NOT LIMITED TO MYALGIAS, ARTHRALGIAS, CHRONIC FATIGUE, AND NIGHT SWEATS.
H3: RECEIVED PER LITIGTION. NO CUSTOMER CONTACT ALLOWED.
DURING A THORACENTESIS PROCEDURE, M.D. NOTED THAT A PIECE OF THE THORACENTESIS CATHETER SHEARED OFF WHILE HE WAS ATTEMPTING TO REMOVE IT FROM THE PLEURAL CAVITY. THE PT WENT TO RADIOLOGY FOR FLUOROSCOPY FOR RETRIEVAL OF THE SHEARED OFF PIECE OF CATHETER. A 4 INCH PIECE OF CATHETER WAS SUCCESSFULLY REMOVED.
A DEVICE HISTORY SEARCH WAS CONDUCTED. THERE WAS NO INFO THAT WOULD INDICATE THAT A PROBLEM WAS FOUND EITHER IN PRODUCTION OR RAW MATERIALS INSPECTIONS. NO UNITS WERE RETURNED FOR EVAL. THE DIRECTIONS FOR USE INCLUDE "WARNING: DO NOT WITHDRAW OR PULL BACK CATHETER THROUGH NEEDLE AT ANY TIME." THE CATHETER CAN BE SEVERED BY THE NEEDLE CAUSING POSSIBLE PT INJURY. CO HAS TRIED TO MITIGATE THIS PROBLEM BY ENCLOSING A BUTTERFLY CLAMP TO LOCK THE CATHETER, SO IT CANNOT BE REMOVED THROUGH THE NEEDLE.
INITIAL BILATERAL IMPLANTATION OCCURED ON 7/23/83 WITH EXPLANT ON 7/27/94. PLAINTIFF ALLEGES VARIOUS SYMPTOMS INCLUDING, BUT NOT LIMITED TO, ULCERATIONS IN MOUTH, CHEST PAIN, MEMORY LOSS, AND SKIN RASHES.
H3: RECEIVED PER LITIGATION. NO CUSTOMER CONTACT ALLOWED.
INITIAL BILATERAL IMPLANTATION ON 10/19/78 WITH EXPLANT ON 9/30/83. PLAINTIFF ALLEGES" INJURIES AS A RESULT OF IMPLANTS CONTAINING OR CONSISTING OF SILICONE, SILICONE GEL, AND/OR AN ELASTOMER MADE OF SILICONE.
MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
CASTER HINGE L RV 1/4-28 X 1.265 BH C/S BLK. DEALER CLAIMS THAT THE HINGE AND BOLT BROKE ON THIS CHAIR.
THREAD ENGAGEMENT INADEQUATE. THIS REPORT OR OTHER INFO SUMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
510K #950928. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
TWO VENTRICULAR SHUNTS WERE INSERTED INTO A PT. BOTH SHUNTS FAILED TO WORK. PHYSICIAN STATES THAT IT WAS A VALVE FAILURE. ADULT VALVES HAD BEEN IMPLANTED AS TREATMENT FOR HYDROCEPHALUS. ONE TO TWO WEEKS POST IMPLANT, NO REDUCTION IN VENTRICLE SIZE WAS NOTED IN CONJUNCTION WITH A INCREASE IN CSF PRESSURE. THE VALVES WERE THEN EXPLANTED WITHOUT REPORT OF INJURY OR COMPLICATIONS. PRE-IMPLANT TESTING WAS NOT PERFORMED ON THESE VALVES AND, ACCORDING TO THE INFO PROVIDED, THE VALVES WERE DISCARDED BY THE OR STAFF FOLLOWING EXPLANT. THESE REPORTS HAVE BEEN BROUGHT TO THE ATTENTION OF CO'S QA DEPT AND THE FDA PER THE MEDICAL DEVICE REPORTING REGULATIONS. PACKAGING AND PRODUCT HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED. HOWEVER, BECAUSE THE PRODUCTS HAVE NOT BEEN RETURNED CO WILL BE UNABLE TO DETERMINE IF THE CAUSES FOR THE REPORTED DIFFICULTIES WERE RELATED TO THE DEVICES.
CASTER HINGE L/R RV. DEALER CLAIMS HINGES ARE STRIPPED.
THREAD ENGAGEMENT INADEQUATE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, IN., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A PROCEDURE, PT RECEIVED A BURN. THE BURN WAS TREATED WITH BURN CREAM AND A TEGADERM DRESSING WAS APPLIED.
THIS REPORT IS BASED ON INFO SUPPLIED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOT ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY CO DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY HAS OCCURRED DUE TO A MALFUNCTION OR USE OF DEVICE; OR THAT ANY CO DEVICE IS LIKELY TO CONTRIBUTE TO A DEATH OR SERIOUS INJURY IN THE EVENT OF A MALFUNCTION.
CASTER HINGE R/L RV. DEALER CLAIMS THE CASTER HINGE IS BROKEN.
THREAD ENGAGEMENT INADEQUATE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
TWO PEDIATRIC INTEGRAL SHUNTS WERE INSERTED INTO A PT. BOTH SHUNTS FAILED TO WORK. THE FIRST VALVE WAS IMPLANTED AND FUNCTIONED WELL FOR APPROX THREE MONTHS. UNDERDRAINAGE WAS THEN SUSPECTED AND THE VALVE WAS EXPLANTED AND REPLACED UNEVENTFULLY WITH THE SECOND VALVE. THIS VALVE REMAINED IMPLANTED FOR TWO WEEKS, AFTER WHICH UNDERDRAINAGE WAS AGAIN SUSPECTED. THIS VALVE WAS THEN EXPLANTED AND REPLACED UNEVENTFULLY WITH A COMPETITOR'S VALVE WITHOUT REPORT OF INJURY OR COMPLICATIONS. THE VALVES WERE DISCARDED BY THE OR STAFF. THESE REPORTS HAVE BEEN BROUGHT TO THE ATTENTION OF CO'S QA DEPT AND THE FDA PER THE MEDICAL DEVICE REPORTING REGULATIONS. PACKAGING AND PRODUCT HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED. HOWEVER, BECAUSE THE PRODUCTS HAVE NOT BEEN RETURNED CO WILL BE UNABLE TO DETERMINE IF THE CAUSES FOR THE REPORTED DIFFICULTIES WERE RELATED TO THE DEVICES.
THE PHYSICIAN REMOVED THE CLAMP FROM THE PT'S AORTA WHEN THE JAW FROM THE CLAMP FRACTURED OFF. ACCORDING TO THE RPTR THERE WAS NO PT INJURY AS A RESULT OF THIS EVENT.
MFG PROCESS MODIFIED FOR BOXLOCK CHANGE AND MODIFICATION TO HEAT TREATMENT CYCLE.
CANNULA "BLEW OFF" SYRINGE, HITTING PT'S EYE AND CAUSING INJURY.
DURING CLINICAL USE, THE BALLOON BURST AT AN INFLATION PRESSURE OF 25 ATMS.  THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAM: THE BALLOON EXHIBITED A 1.0 CM LONG, AXIALLY-DIRECTED TEAR, 1.3 CM PROXIMAL TO THE DISTAL TIP. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION. FURTHER, AN AXIAL TEAR IS INDICATIVE OF INFLATION IN EXCESS OF THE RATED BURST PRESSURE (16 ATMS) FOR THIS BALLOON.
LEAKY TPN BAG DUE TO POOR SEAL AT BAG STEM WHERE SPIKE IS PLACED INTO THE BAG.
X-TUBE ASSM 18" X 16". DEALER CLAIMS X-TUBE BROKE.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OT THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
MFG DEFECT. SYRINGE HAS 2 12 ML MARKS AND NO 13ML MARK.
X-TUBE ASSM 16" X 16". DEALER CLAIMNS X-TUBE BROKE AT THE CENTER OF THE HINGE.
HIGH STRESS FACTOR AT CTR AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING CLINICAL USE, THE BALLOON BURST AT AN INFLATION PRESSURE OF 8 ATMS. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS.
THE PRODUCT HAS NOT BEEN RETURNED TO CO FOR EVALUATION AND TESTING. THIS FILE IS CONSIDERED CLOSED. SHOULD THE PRODUCT BE RETURNED AT A LATER DATE, A FOLLOE UP WIL BE SUBMITTED FOR CO'S REVIEW.
THE BALLOON BURST CICUMFERENTIALLY AT AN INFLATION PRESSURE OF 20 ATMOSPHERES WITHIN A DIALYSIS FISTULA.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE CATHETER'S BODY WAS NOTED TO BE FRACTURED, 67 CM FROM THE PROXIMAL END. THE BALLOON EXHIBITED A CIRCUMFERENTIALLY-DIRECTED FRACTURED CONDITIONS OF THE CATHETER, IT IS SUSPECTED THAT THE CATHETER WAS EXPOSED TO EXTENSIVE TENSIONS. MICROSCOPIC EXAMINATION: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF SEVERAL SURFACE ABRASIONS ADJACENT AND PARALLEL TO THE AXIALLY AND CIRCUMFERENTIALLY-DIRECTED TEAR. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
X-TUBE ASSM 18" X 16". DEALER CLAIMS X-TUBE BROKEN AT TOP LEFT SIDE.
HIGH STRESS FACTOR AT CTR AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE COVER OF THE TIP OF THE FORCEP CAME OFF AFTER 10 TIMES EXCISING THE MENICUS. TEH SURGEON WOULD LIKE AN EXPLANATION OF WHY THIS HAPPENED SO EASILY. THE COVER WAS NOT RETURNED.
MARKETING PEOPLE HAS NOT BEEN ABLE TO GET SOME OF ADDITIONAL INFO ON COMPLAINT #529353 FROM THE DR., BECAUSE MANY DAYS PASSED FROM ITS OCCURRENCE.
ON 8/13/96, PT UNDERWENT A SUBOCCIPITAL CRANIOTOMY AND A LAMINECTOMY AND DURAL GRAFT. A CULTURE OF THE DURAL GRAFT WAS DONE DURING THIS OPERATIVE PROCEDURE. THE CULTURE WAS READ TO BE POSITIVE FOR ASPERGILLUS. ON 8/29/96, THE CHILD RETURNED TO THE OR FOR REMOVAL OF THE DURAL GRAFT. THE PT IS RECOVERING WITH NO KNOWN COMPLICATIONS AT THE TIME OF THIS REPORT.
DURING A DIALYSIS TREATMENT, THERE WAS A WEIGHT GAIN OF APPROX .03 LB. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE PT DID NOT RECEIVE ANY MEDICAL INTERVENTION OR ADD'L TREATMENT. A MES (MEDICAL EQUIP SVC) TECH EXAMINED THE MACHINE AND RPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC S/N MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC S/N MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED )FAILED). THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED THAT THE FUSE WAS OPEN (METER READ "OL", OR "OPEN LINE"). THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION(P.3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALVE TO THE ACTUAL VALVE AFTER THE TREAMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016.
PT IS A 33 Y/O FEMALE WHO WAS ORIGINALLY ADMITTED ON 6/4/96 FOR PLACEMENT OF LUMBAR VALVE FOR LUMBAR-PERITONEAL SHUNTING. PT LATER DEVELOPED HEADACHES AND DIZZINESS AND DEVICE WAS REMOVED AND REPLACED ON 8/5/96.
X-TUBE ASSM 18" X 18". DEALER CLAIMS X-TUBE BROKE AT THE CTR.
PT HAD A 9 FR, 40CC INTRA-AORTIC BALLOON INSERTED ON 8/17/96. THE BALLOON DEVELOPED A LEAK ON 8/19/96. IT WAS REMOVED AND REPLACED WITH ANOTHER CO'S BALLOON. THE PT DID NOT SUFFER ANY ADVERSE EFFECTS FROM THE FAILURE OTHER THAN HAVING TO RETURN TO THE CATH LAB FOR REPLACEMENT OF THE BALLOON.
PT IS A 33 Y/O FEMALE WHO WAS ORIGINALLY ADMITTED ON 6/4/96 FOR PLACEMENT OF H-V LUMBAR VALVE FOR LUMBAR-PERITONEAL SHUNTING. PT LATER DEVELOPED HEADACHES AND DIZZINESS AND DEVICE WAS REMOVED AND REPLACED ON 8/5/96.
THE PRODUCT HAS BEEN RETURNED TO CO FOR EVAL AND TESTING, HOWEVER, THE ENGINEERING EVAL IS NOT YET COMPLETE. PLEASE NOTE DATE OF 10/16/96 FOR SUBMISSION OF SUCH INFO PENDING COMPLETION OF THE ANALYSIS. B-1 SHOULD BE ADVERSE EVENT ON UF REPORT.
PACER WAS NOT SENSING CORRECTLY. WOULD NOT PACE THE VENTRICLE AT THE RATE THAT WAS DIALED IN. ANOTHER PACER WAS USED. PT EXPIRED. DEATH NOT ATTRIBUTED TO PACER.
PT HAD CAPSULAR CONTRACTURE AND FATIGUE WITH BREAST IMPLANTS AND CHOSE TO HAVE THEM REMOVED.
UPON DEPLOYMENT OF STENT, THIS BALLOON CATHETER CREATED A DISSECTION WHICH WAS SUCCESSFULLY TREATED WITH A TWENTY MINUTE INFLATION WITH A PROFUSION BALLOON. THE PT HAS NOT SUSTAINED ANY ADVERSE EFFECT FROM THIS EVENT. WHILE NO SERIOUS INJURY OR ILLNESS OCCURRED, SURGICAL INTERVENTION WAS REQUIRED TO PREVENT PT IMPACT.
H.6 METHOD-REVIEW OF MFG RECORDS. DISCUSSION WITH CLINICAL SPECIALIST. NO PRODUCT WAS RETURNED FOR EVAL. A REVIEW OF CO MFG RECORDS DID NOT REVEAL ANY PROBLEMS. UNFORTUNATELY, FROM THE LIMITED INFO, CO IS UNABLE TO DETERMINE WHY THIS EVENT MAY HAVE OCCURRED.
DEVICE DISASSEMBLED DURING USE AND LODGED IN PT'S SKULL.
UNAVAILABLE DEVICE WAS NOT RETURNED FOR EVAL. FOR
FEEDING TUBE WAS INSERTED INADVERTANTLY IN PT'S RIGHT LUNG RESULTING IN PNEUMOTHORAX. TUBE WAS REMOVED ABOUT ONE (1) HR LATER AFTER X-RAY VERIFICATION OF PLACEMENT. NO FLUID WAS EVER INTRODUCED INTO THE TUBE. DEVICE IS NEW.
ANSWERS TO FREQUENCY AND SEVERITY QUESTIONS: NO, NO, YES, NO. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS AND TO BE CLEAN. THE PT'S ALLERGIC CONDITION IS A LIKELY CONTRIBUTOR TO IMPLANT FAILURE.
DURING A TURP PROCEDURE, THE TIP OF THE RESECTOSCOPE SHEATH BROKE OFF AND WAS LOCATED BY X-RAY. PT RETURNED ON 8/3 FOR A FOLLOW-UP CYSTOSCOPY AND THE BROKEN PIECE WAS RETRIEVED. THE RISK MGR, WHO HAS THE SUBJECT SHEATH, IS ON VACATION AND WILL NOT RETURN UNTIL THE 1ST WEEK OF SEPT. THE LAST PURCHASE RECORD AND SVC RECORD OF THIS SHEATH WITH THIS ACCOUNT WAS 8/93. THEREFORE CO BELIEVES THE SHEATH IS ABOUT 3 YEARS OLD. THE BEAK OF THE SHEATH IS CERAMIC MATERIAL WHICH IS VERY BURN RESISTANT, YET BRITTLE. THE BREAKAGE OF THE SHEATH WAS MOST PROBABLY DUE TO LONG USE.
NURSE WAS PICKING UP SHARPS CONTAINER WHEN STUCK WITH NEEDLE THAT WAS PROTRUDING FROM SPACE IN LID OF CONTAINER. NO MEDICAL TREATMENT REQUIRED.
ASST. RISK MGR STATED THAT THE DEVICE WAS REMOVED (SURGICALLY EXPLANTED) BECAUSE IT DID NOT FUNCTION. NO ADD'L INFO WAS AVAILABLE.
NO FURTHER INFO IS AVAILABLE AS OF 9/3/96. UPON DECONTAMINATION, DEVICE IS BEING RETURNED TO MFR. THE FREQUENCY OF THIS EVENT DOES NOT APPEAR TO BE INCREASING. THE SEVERITY IS NOT INCREASING. THE REASON FOR THE EXPLANT PROCEDURE IS UNKNOWN.
ONCOLOGY OFFICE HAD DIFFICULTY ASPIRATING THE PORT. RADIOLOGY CONFIRMED CATHETER SHEAR. EXPLANT OF DEVICE WAS DONE.
DEVICE NOT RELEASED BY FACILITY FOR ANALYSIS. THIS PROBLEM IS DESCRIBED IN THE PRODUCT'S IFU AND IS KNOWN COMPLICATION WITH THIS DEVICE TYPE. THE FREQUENCY/SEVERITY OF THE EVENT DOES NOT APPEAR TO BE INCREASING. EVENTS OF THIS TYPE GENERALLY REQUIRE SURGICAL INTERVENTION TO REMOVE BOTH THE PORT AND THE CATHETER.
X-TUBE ASSM 17" X 18". DEALER CLAINS X-TUBE BROKE AT THE CENTER BBOLT.
HIGH STRESS FACTOR AT CTR AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FORMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
NUMEROUS INCIDENTS OF LEAKING TUBING AND DRAINBAGS OF CO'S DISPOSABLE HOME PERITONEAL DIALYSIS SYSTEMS. ONGOING PROBLEM HAS BEEN DISCUSSED WITH CO. SOME PRODUCTS HAVE BEEN RETURNED. PROBLEM CONTINUES UNRESOLVED AND CONCERN FOR POTENTIAL ADVERSE EVENT SUCH AS PERITONITIS OR OTHER INFECTION REMAINS. ADD'L LOT NUMBERS C-326801, C-311-35, C-318352.
X-TUBE ASSM 17" X 18". DEALER CLAIMS X-TUBE BROKE. DEALER HAS NO DETAIL.
HIGH STRESS FACTOR AT CENTER ADN END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION  BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSE OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT WAS SEEN IN THE ER AFTER A MOTOR VEHICLE ACCIDENT. PT HAD A HEAD INJURY AND POSSIBLE INTERNAL TRAUMA. PT WENT FOR CAT SCANS. DURING CT, TECHNICAL DIFFICULTIES WERE ENCOUNTERED. REVIEW OF CT SCAN NOTES "TECHNICAL FAILURE AND FOLLOW-UP FILMS THROUGH THE ABDOMEN WERE DELAYED UP TO 25 MINS." PT UNSTABLE, WENT INTO DISTRESS DURING DELAY AND WAS RETURNED TO ER. PT CODED THERE AND EXPIRED.
X-TUBE ASSM 20" X 18". DEALER CLAIMS X-TUBE BROKE AT THE MIDDLE BOLT.
NURSE AND AIDE WERE USING LIFT TO TRANSFER PT FROM CHAIR BACK INTO BED. RESIDENT SLID FROM SLING AND FELL TO THE FLOOR DURING TRANSFER. SLING WAS CORRECTLY ATTACHED TO LIFT AND THERE WAS A RUBBER PAD AND CHUX UNDERPAD BETWEEN PT AND SLING. APPARENTLY DURING TRANSFER THE PT STIFFENED, ARCHED HER BACK AND STRAIGHTENED HER LEGS WHICH ALLOWED HER TO SLIDE OUT OF SLING.
BLOOD LEAK OCCURRENCE INTO DIALYSATE PATH TOWARD THE END OF DIALYSIS. TREATMENT WAS TERMINATED EARLIER. PT REMAINED WITH STABLE VITAL SIGNS. PHYSICIAN NOTIFIED AND THE FOLLOWING ACTIONS WERE PRESCRIBED. BLOOD CULTURES X2. ANTIBIOTIC COVERAGE. OPERATOR STATED THAT THERE WAS NO BLOOD LEAK ALARM THAT SOUNDED. ONLY HIGH PRESSURE VEN PRESSURE ALARM. TROUBLESHOOT UNIT - FOUND DEFECTIVE. WOULD NOT ALLOW CALIBRATION OF BLOOD LEAK SENSOR. REPLACED BD CALIBRATE TEST OK.
BLOOD LEAK OCCURRENCE INTO DIALYSATE PATH TOWARD THE END OF DIALYSIS. TREATMENT WAS TERMINATED EARLIER. PT REMAINED WITH STABLE VITAL SIGNS. PHYSICIAN NOTIFIED AND THE FOLLOWING ACTIONS WERE PRESCRIBED. BLOOD CULTURES X 2. ANTIBIOTIC COVERAGE. OPERATOR STATED THAT THERE WAS NO BLOOD LEAK ALARM THAT SOUNDED. ONLY HIGH PRESSURE VEN PRESSURE ALARM. TROUBLESHOOT UNIT - FOUND DEFECTIVE. WOULD NOT ALLOW CALIBRATION OF BLOOD LEAK SENSOR. REPLACED BD. CALIBRATE TEST OK.
X-TUBE ASSM 16" X 16". DEALER CLAIMS X-TUBE BROKE AT CENTER BOLT.
HIGH STRESS FACTOR AT CTRR AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED DTO THE REPORTABLE EVENT.
HUB ON ARTERIAL SIDE OF LONG TERM HEMODIALYSIS BROKE OFF (NOT RETAINED) AND COULD NOT BE REPAIRED. PT REQUIRED SURGICAL REMOVAL OF BROKEN CATHETER AND PLACEMENT OF NEW ONE. PT TOLERATED PROCEDURE WITHOUT COMPLICATION.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WIRE UNRAVELED DURING STENT PLACEMENT IN CARDIAC CATHETERIZATION LAB. WIRE REPLACED WITH NEW AND STENT PLACEMENT CONTINUED.
PT WITH CORONARY ATHEROSCLEROSIS HAD A PLANNED STENT OF THE RIGHT CORONARY ARTERY. EXPERIENCED A PREMATURE RUPTURE OF THE BALLOON BEFORE REACHING 8ATM. WHILE TRYING TO REMOVE IT, IT OCCLUDED THE INTERNAL DIAMETER OF THE GUIDING CATHETER, PREVENTING REMOVAL OF THE STENT BALLOON CATHETER. THE BALLOON TIP WAS INADVERTANTLY SEVERED DURING THIS PROCESS. TIP RETRIEVED FROM THE CORONARY ARTERY ONLY BY EVENTUALLY REMOVING THE GUIDING CATHETER, BALLOON CATHETER, AND WIRE. SALES REP ON SITE LATER THAT DAY AND TOOK DEVICE FOR FURTHER EVALUATION.
NEWBORN WITH AN ORAL-GASTRIC FEEDING TUBE. TUBE WAS REMOVED FOR WEEKLY TUBE CHANGE. ON REMOVAL, NURSE NOTED THAT TIP WAS JUST BARELY CONNECTED. TIP EASILY DISCONNECTED WHEN CHECKED.
X-TUBE ASSM 18" X 16". DEALER CLAIMS X-TUBE BROKE AT TIP WHERE SEAT TUBE IS ATTACHED.
HIGH STRESS FACTOR AT CTR AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OR THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESINGS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
NEWBORN IN ISOLETTE WITH PERIPHERAL INTRAVENOUS CENTRAL CATHETER (PICC). NURSE NOTED THAT CATHETER WAS SEVERED APPROX 1CM FROM THE BLUE HUB. A NEEDLELESS CONNECTOR HAD BEEN USED TO CONNECT THE TUBING TO THE CATHETER. THE NURSE STATED THAT SHE DOUBLTED THE POSSIBILITY OF THE TUBING HAVING BEEN CUT - NO PORCEDURES DONE IN THAT VICINITY WITH SCISSORS, ETC. ALSO DOUBTS THAT TUBE CAUGHT IN DOOR AND PINCHED. SUSPECTS THAT THE WEIGHT OF THE CONNECTOR MAY HAVE BEEN A FACTOR - IT HAD COME UNTAPED FROM THE PT AND WAS HANGING OVER THE SIDE OF THE BED SURFACE.
X-TUBE ASSM 18" X 18". DEALER CLAIMS X-TUBE BROKE.
HIGH STRESS FACTOR AT CTR AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OR THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED THE THE REPORTABLE EVENT.
DENTAL IMPLANT FAILED. DR WAS SENT INVESTIGATION FORM.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT BECAUSE IT WAS NON-FUNCTIONAL. AN IPP DEVICE WAS IMPLANTED.
CYLINDER DID NOT PASS THE BEND TEST. CYLINDER DID NOT PASS THE BEND TEST.
X-TUBE ASSM 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CTR AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC, UNBDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSE OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT AND AN IPP DEVICE IMPLANTED DUE TO ASYMMETRICAL CYLINDER ALIGNMENT.
X-TUBE ASSM 16" X 17". DEALER CLAIMS X-TUBE BROKE ON THE TOP PORTION.
HIGH STRESS FACTOR AT CTR AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DECISNGS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT AND AN IPP DEVICE IMPLANTED DUE TO PT DISSATISFACTION.
THE LEFT CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO ASYMMETRY OF RIGID PENIS WITH LEFT 2 CM SHORTER THAN RIGHT.
THE INVESTIGATIVE WORKSHEET STATED THAT A 16ML 3.7MMD IMPLANT WAS PLACED IN THE #22 AREA AND A 10MML 3.75MMD IMPLANT WAS PLACED IN THE #31 AREA OF THE MANDIBLE ON 1/3/96. THE IMPLANTS FAILEDTO OSSEOINTEGRATE AND WERE REMOVED ON 6/25/96. THE PANORAMIC RADIOGRAPH DATED 1/3/96 SHOWED A 16MML 3.7 VENT IMPLANT IN THE #22 AREAS AND A 10MML 3.75MMD IMPLANT IN THE #31 AREA OF THE MANDIBLE. AFTER STUDING THE X-RAYS AND REVIEWING REPORT, CO FINDS NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANTS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUY THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE INVESTIGATIVE WORKSHEET STATED THAT A 16MML 3.7MMD IMPLANT WAS PLACED IN THE #22 AREA AND A 10MML 3.75 IMPLANT WAS PLACED IN THE #31 AREA OF THE MANDIBLE ON 1/3/96. THE IMPLANTS FAILED TO OSSEOINTEGRATE AND WERE REMOVED ON 6/25/96. THE PANORAMIC RADIOGRAPH DATED 1/3/96 SHOWED A 16MML 3.7MMD IMPLANT IN THE #22 AREAS AND A 10MML 3.75 IMPLANT IN THE #31 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FINDS NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANTS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSED LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
X-TUBE ASSM 16" X 15". DEALER CLAIMS X-TUBE BROKE AT CENTER BOLT.
HIGH STRESS FACTOR AT CTR AND END OF X-TUBE. THIS REPRT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INF, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, IN., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO PT DISSATISFACTION-FAILED PROSTHESIS.
A THOROUGH INVESTIGATION CANNOT BE COMPLETED WITHOUT ADD'L INFO. CO'S MAKING A SECOND REQUEST FOR ADD'L INFO.
X-TUBE ASSM 13" X 17". DEALER CLAIMS X-TUBE IS VENT AND CRACKED IN THE FRONT AT THE WELD.
HIGH STRESS FACTOR AT CTR AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OR THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BU QUICK DESIGNS, INC. OR THE FDA THAT THE DEDIVE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WITHOUT ADD'L INFO A THOROUGH INVESTIGATION CANNOT BE COMPLETED. CO IS MAKING A SECOND REQUEST FOR THE ADD'L INFO.
X-TUBE ASSM 18" X 17". DEALER CLAIMS THE X-TUBE BROKE AT THE CROSS BOLT.
HIGH STRESS FACTOR AT THE CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WITHOUT THIS ADD'L INFO A THOROUGH INVESTIGATION CANNOT BE COMPLETED. CO IS MAKING A SECOND REQUEST FOR ADD'L INFO.
DEVICE WAS REMOVED FROM THE PT AND AN IPP DEVICE IMPLANTED BECAUSE THE RIGHT CYLINDER WOULD NOT INFLATE.
ISOLATED INCIDENT OF CONTROL SYRINGE FAILURE TO MAKE TIGHT CONNECTION WITH MANIFOLD. THIS RESULTED IN AN AIR EMBOLUS DELIVERED INTO THE LEFT CORONARY ARTERY DURING INJECTION OF CONTRAST. PT DEVELOPED CHEST PAIN AND PREPARATIONS WERE MADE TO INSERT IABP. THIS EPISODE WAS TRANSIENT AND THE PT WAS STABILIZED.
THE IPP DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
WITHOUT ADD'L INFO A THOROUGH INVESTIGATION CANNOT BE COMPLETED. CO IS MAKING A SECOND REQUEST FOR ADD'L INFO.
ON 11/26/90, AN IPP DEVICE WAS IMPLANTED. ON 9/5/96, THE LEFT CYLINDER WAS REVISED. ON 4/12/96, THE RIGHT CYLINDER, PUMP AND RESERVOIR WERE REVISED. ON 7/29/96, THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION-PUMPS/SCROTUM.
PT REPORTEDLY RECEIVED A LEFT NASAL BURN APPROX 1MM ROUND DURING SURGICAL PROCEDURE. THE BURN WAS ALLEGEDLY CAUSED BY THE SUCTION BOVIE. A PIN POINT HOLE WAS NOTED IN THE BOVIE INSULATION AFTER THE BURN OCCURRED. THE AREA WAS TREATED WITH BACITRACIN OINTMENT.
THE INVESTIGATIVE WORKSHEET STATED THAT A 16MML 3.7 IMPLANT WAS PLAED IN THE #22 AREA OF THE MANDIBLE ON 11/9/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 5/15/96. THE PANORAMIC RADIOGRAPH DATED 11/9/95 SHOWED THE 16MML 3.7MMD IMPLANT IN THE #22 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FINDS NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM MAINTAINING OSSEOINTEGRATION. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DETNAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
ON 2/19/91 AN IPP DEVICE WAS IMPLANTED. ON 7/15/92 AND 4/20/94 THE CYLINDERS AND PUMP WERE REVISED. ON 7/31/96 THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO THE LEFT CYLINDER BEING RUPTURED.
CYLINDER WAS FUNCIONAL. CYLINDER HAS A WEAR LEAK.
THE INVESTIGATIVE WORKSHEET STATED THAT A MML 3.75MMD IMPLANT WAS PLACED IN THE #27 AREA OF THE MANDIBLE TO HELP RETAIN A FULL LOWER DENTURE. THE PROSTHESIS WAS IN FUNCTION FOR FOUR MONTHS BEFORE THE IMPLANT FAILED TO MAINTAIN OSSEOINTEGRATION AND HAD TO BE REMOVED. THE PANORAMIC RADIOGRAPH DATED 7/29/96 SHOWED A 10MML 3.75MMD IMPLANT IN THE #27 AREA SUPPORTING A TITANIUM BALL SCREW ABUTMENT (TSB). AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FINDS THAT THE PT COULD HAVE PLACE MORE FUNCTIONAL LOAD ON THE TSB ABUTMENT THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS RECOMMENDED TO USE A BIGGER IMPLANT FOR THE ADD'L SUPPORT AND TO CHECK TO MAKE SURE THE DENTURE IS TOTALLY TISSUE SUPPORTED.
WITHOUT ADD'L INFO A THOROUGH INVESTIGATION CANNOT BE COMPLETED. CO IS MAKING A REQUEST FOR THE ADD'L INFO.
A 3.0 STENT (REPORTEDLY CUT IN HALF BY DR PRIOR TO IMPLANTATION) WAS INTRODUCED ONTO A FL 3.5 ANOTHER CO'S GUIDING CATHETER, POSITIONED AND INFLATED. THE DR REMOVED STENT WITH 4.0 SNARE. WHEN EQUIPMENT WITHDRAWN STENT COULD NOT BE FOUND IN EQUIPMENT AND ALLEGEDLY EMBOLIZED. WHEREABOUTS OF STENT UNKNOWN. NO TREATMENT REQUIRED PER PHYSICIAN. PT EXPIRED 6 DAYS LATER OF ACUTE CARDIAC/RESPIRATORY FAILURE SECONDARY TO MYOCARDIAL INFARCTION AND CORONARY ARTERY DISEASE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION AND PAINFUL PENILE PROSTHESIS.
THE INVESTIGATIVE WORKSHEET STATED THAT AN 8MML 3.75MMD IMPLANT WAS PLACED IN THE #6 AREA OF THE MAXILLA ON 3/13/96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 6/26/96. THE PERIAPICAL RADIOGRAPH DATED 1/13/96 SHOWED AN 8MML 3.75MMD IMPLANT IN THE #6 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FINDS NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM MAINTAING OSSEOINTEGRATION. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOUCS OF THIS INVESTIGATION.
DURING PLACEMENT OF A SUBCUTANEOUS VENOUS PORT, A CATHETER WAS INTRODUCED THROUGH A SHEATH. WHILE WITHDRAWING THE SHEATH, THE SHEATH ALLEGEDLY BROKE OFF HALF WAY. A PIECE OF THE SHEATH MEASURING ABOUT 2 1/2 INCHES IN LENGTH WAS REPORTEDLY RETRIEVED FROM THE PT WITHOUT DIFFICULTY.
WITHOUT INFO A THOROUGH INVESTIGATION CANNOT BE COMPLETED. CO IS MAKING A SECOND REQUEST FOR ADDITIONAL INFO.
INFORMATION RECEIVED ON 9/23/96 INDICATES ONE CYLINDER WAS REMOVED FROM THE PATIENT DUE TO EROSION THROUGH THE URETHRA. UNABLE TO OBTAIN ADDITIONAL IMPLANT INFORMATION. INFORMATION RECEIVED ON 10/16/96 INDICATES ADDITIONAL REASON FOR REMOVAL AS INFECTION.
THE IPP WAS REMOVED FROM THE PT ON 4/16/96, REASON NOT INDICATED, AND ANOTHER DEVICE IMPLANTED. CO HAS REQUESTED ADD'L INFO.
WHILE PT WAS UNDERGOING DIALYSIS, BLOOD PUMP REPORTEDLY STOPPED WITHOUT AUDIBLE OR VISUAL ALARM. STAFF REPORTEDLY UNABLE TO START BLOOD PUMP BY TURNING BLOOD PUMP SWITCH ON/OFF. MACHINE WAS REPORTEDLY TURNED ON/OFF X3 WITHIN 5 MINS WITH BRIEF PERIOD OF FUNCTION FOLLOWED BY THE BLOOD PUMP STOPPING WITH NO ALARMS SOUNDING ON ALL THREE ATTEMPTS. IMMEDIATELY FOLLOWING ABOVE, BLOOD PUMP WAS REPORTEDLY FUNCTIONING WHEN VISUAL BLOOD LEAK ALARMED WITHOUT AUDIBLE ALARM OR STOPPING OF PUMP. APPROX ONE MIN AFTER VISUAL ALARM FRANK BLOOD ALLEGEDLY SEEN IN DIALYSATE LINES DUE TO ALLEGED MEMBRANE RUPTURE. DIALYSIS TERMINATED WITHOUT RETURNING OF BLOOD TO PT. CO REP REPORTS CORROSION OF WIRING HARNESS AND CONNECTOR TO P10 OF MOTOR CONTROL BOARD. THE PT DID NOT REQUIRE ANY TREATMENT OR SUFFER ANY ADVERSE EFFECTS.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. CYLINDER WAS FUNCTIONAL.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-LEFT CYLINDER.
AN IPP DEVICE WAS IMPLANTED ON 12/27/93. THE RESERVOIR WAS REVISED ON 1/5/95. A CONNECTOR WAS REVISED ON 4/16/96. THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS ON 7/22/96.
HIP PROSTHESIS WAS IMPLANTED ON 5/1/96. ON 5/2/96, PT REPORTEDLY IN BED WITH ABDUCTION PILLOW BETWEEN KNEES, LYING ON RIGHT SIDE, REPORTS FEELING A "CLICK" WITH REPOSITIONING IN BED. ON 5/2/96, CLOSED REDUCTION OF DISLOCATED HIP PERFORMED. SURGEON REPORTS "CLICK" WHEN HIP BROUGHT IN FROM FLEXION TO EXTENSION AND ALLEGEDLY FELT THERE WAS TOO MUCH "PLAY" IN THE HIP PROSTHESIS. ON 5/7/96, RETURNED TO SURGERY FOR REVISION OF ACETABULAR SHELL AND REPLACEMENT OF FEMORAL HEAD DUE TO ALLEGED DISSOCIATION OF THE SHELL FROM THE LINER. THE RING, LINER AND BALL FROM THE 5/1 HIP REPLACEMENT WAS EXPLANTED AND CO ACETABULAR LOCK RING, RING LOCK ACETABULAR LINER AND MODULAR HEAD COMPONENT WERE IMPLANTED. THE PT HAD AN UNEVENTFUL POST-OP COURSE AFTER THE 5/7/96 REVISION.
AN IPP DEVICE WAS IMPLANTED ON 11/26/91. REAR TIP EXTENDERS WERE IMPLANTED ON 3/11/92. THE CYLINDER WERE REVISED ON 9/8/92. THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS ON 7/24/96.
DURING PTCA WITH CORONARY STENTING THE SAPHENOUS VEIN BYPASS GRAFT TO THE INTERMEDIATE RAMUS BRANCH OF THE CIRCUMFLEX CORONARY ARTERY WAS REPORTEDLY STENTED X2 USING A 3.0 STENT AT THE PROXIMAL SITE AND A 3.0 STENT AT THE DISTAL SITE. REPORTEDLY, AN ATTEMPT WAS MADE TO ADVANCE A .014" STRAIGHT GUIDE WIRE DOWN THE GRAFT FOR POST DILATION OF THE DISTAL STENT. WHEN THIS WIRE WAS RETRACTED IT ALLEGEDLY BECAME ENTRAPPED AND WAS FRACTURED WITH A 2.0CM SEGMENT RETAINED WITHIN THE SAPHENOUS VEIN BYPASS GRAFT. THE PT WAS DISCHARGED 5/20/96 AFTER AN UNEVENTFUL COURSE. PT WAS READMITTED 5/21/96 WITH CVA REPORTED TO BE UNRELATED TO ABOVE.
INFO RECEIVED ON 8/1/96 INDICATES THE PT REPORTS THAT THE PUMP STAYS FLAT AFTER 2-3 SQUEEZES. ADD'L INFO RECEIVED ON 8/26/96 AND 8/27/96 INDICATES THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A HOLE IN ONE CYLINDER-POSSIBLE ANEURYSM.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD A WEAR LEAK. CYLINDER HAD OR DAMAGE. CYLINDER WAS FUNCTIONAL.
H11: PARTIAL INFO IN SECTION F PROVIDED BY CUSTOMER'S INITIAL REPORT. NO ADDITIONAL INFO RECEIVED TO DATE. F-10: 1757 - LABELED; 1422 - NA. CODES PROVIDED BY MFR. B-4: 8/1/96.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
THE IPP DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED BECAUSE IT WOULD NOT INFLATE.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. TUBING WAS FUNCTIONAL.
WHILE CONNECTED TO A PT, THE THERAPIST NOTICED THAT ALL OF THE FRONT PANEL LIGHTS WERE BLINKING AND THERE WAS A CHIRPING ALARM. THE PT WAS REMOVED FROM THE VENTILATOR WITH NO INJURY.
492-PC BOARDS WERE REPLACED. 61- THE BOARDS WERE EVALUATED BY THE MFR AND FOUND THE CAUSE OT THE FAILUIRE WAS RELATED TO LIQUID SPILLAGE.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-RESERVOIR, HOLE AT FOLD.
THE REAR TIP EXTENDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO THE CYLINDERS BEING TOO LONG.
AFTER IABP FOR A DAYS, THE IAB LEAKED. THE DOCTOR HAD DIFFICULTY REMOVING THE IAB. AS A RESULT OF THE EVENT, THE PT HAD A THROMBUS.
UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. THE PENETRATION HAS THE CHARACTERISTICS TYPICALLY PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECT TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY.
ON 5/7/91, AN IPP DEVICE WAS IMPLANTED. ON 12/2/94, THE PUMP WAS REVISED. ON 7/26/96, THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED. DUE TO A LEAK IN THE LEFT CYLINDER.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT DUE TO EROSION-CORPORA INTO URETHRA.
A CONNECTOR WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
AN IPP DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A "MALFUNCTION." UNABLE TO OBTAIN ADD'L INFO.
PUMP PERFOMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK.
RHEUMATIC HEART DISEASE, CHRONIC ATRIAL FIBRILLATION, DETERIORATION.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO PAIN-DISTAL TIPS OF PENIS.THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO PAIN-DISTAL TIPS OF PENIS.
THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOUR PEROFRMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE.
EVALUATION OF THE DEVICE IN MFG'S LABORATORY REVEALED EXTENSIVE CALCIFICATION WITHIN EACH CUSP WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS, INCLUDING DETACHMENT OF THE RIGHT AND NONCORONARY CUSPS, AS WELL AS INCOMPLETE COAPTATION. HOST TISSUE OVERGROWTH ENCROACHED ONTO EACH CUSP, CONTRIBUTING TO STENOSIS OF THE VALVE. STENT DISTORTION WAS ALSO NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. ARAY ANALYSIS REVEALED CALCIFICATION WITHIN THE AORTIC WALL AND BELLY OF EACH CUSP, ESPECIALLY CONCTRATED AT EACH ATTACHMENT SITE. ADDITIONALLY, CALCIFICATION WAS NOTED IN THE FREE MARGINS OF THE LEFT AND NONCORONARY CUSPS. THE PRIMARY CARE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO EXTENSIVE CALCIFICATION.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. TUBING WAS FUNCTIONAL.
ON 3/4/85, AN IPP DEVICE WAS IMPLANTED. ON 12/19/85, A CONNECTOR WAS REVISED. ON 10/30/86, THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO FRACTURED RESERVOIR TUBING AT THE CONNECTOR.
THE DOCTOR WAS UNABLE TO REMOVE THE IAB. NO BLOOD WAS NOTED. THE IAB WAS SURGICALLY REMOVED. THE CONTACT REPORTED THAT "THE CATHETER MEMBRANE  APPEARED TO BE BUNCHED UP."
UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A SMOOTH-EDGED PENETRATION WAS SEEN AT THE LEAK SITE WITH NO ACCOMPANYING MARKS. THIS TYPE OF PENETRATION IS TYPICAL OF THAT CAUSED BY CONTACT WITH A SHARP OBJECT.
ON 3/4/85, AN IPP DEVICE WAS IMPLANTED ON 12/19/85, A CONNECTOR WAS REVISED. ON 10/30/86, THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO FRACTURED RESERVOIR TUBING AT THE CONNECTOR.
ON 3/4/85, AN IPP DEVICE WAS IMPLANTED. ON 12/19/85, A CONNECTOR WAS REVISED. ON 10/30/86, THE RESERVOIR WAS REVISED. ON 6/20/91, THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO A LEAK ON RIGHT SIDE CYLINDER.
ALLEGED INFECTION OF UNK ETIOLOGY. FOLLOW-UP FINDINGS: PER PHYSICIAN, ETIOLOGY UNK.
DEVICE EVAL METHOD CODE 86= DEVICE WAS NOT RETURNED FOR EVAL.
ON 8/28/81, AN IPP DEVICE WAS IMPLANTED. ON 5/29/84, CYLINDERS AND PUMP WERE REVISED. ON 7/29/96, THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO IT NOT WORKING-WORN OUT.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDER.
REGURGITATION SECONDARY TO DETERIORATION, CONGESTIVE HEART FAILURE WAS REPORTED.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO PROXIMAL MIGRATION OF RIGHT CYLINDER WITH STT DEFORMITY AND AUTO INFLATION.
ALLEGED INFECTION. FOLLOW-UP FINDINGS: ETIOLOGY UNK.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE.
THE IPP DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACTION. "NON-FUNCTIONING."
PT ALSO ALLEGES HAVING NO PROBLEMS UNTIL ABOUT 3 MONTHS AGO (I.E. MAY, 1996) WHEN SHE BEGAN HAVING PAIN IN BOTH BREASTS. PT STATES HER DR SAID HER IMPLANTS ARE LEAKING.
THE IPP DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO MECHANICAL FAILURE.
PUMP HAD A FATIGUE LEAK. CYLINDER HAD OR DAMAGE. CYLINDER WAS FUNCTIONAL.
ABUTMENT BROKE. PT WAS GARDENING AND THE HANDLE OF THE RAKE HIT THE PT IN THE JAW AND FRACTURED THE ABUTMENT. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENTS THEMSELVES. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.'S OFFICE.
ON 1/24/90, AN IPP PUMP WAS IMPLANTED. THE CYLINDERS AND RESERVOIR WERE IMPLANTED, DATE NOT INDICATED. ON 3/9/94, AND 11/27/95, THE PUMP WAS REVISED. ON 7/29/96, THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO A CONNECTOR FAILURE BETWEEN THE PUMP AND RESERVOIR.
PT RECEIVED IMPLANTS OF AN UNKNOWN MFR ON AN UNKNOWN DATE. PHYSICIAN REPORTS PT HAS LEAKING IMPLANTS.
THE IPP DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS-CYLINDER.
ABUTMENT BROKE WHILE IN FUNCTION. A THREE UNIT BRIDGE WAS SUPPORTED BY ONE IMPLANT. PT HAD PRIOR EVENT REPORTED ON MDR #M758482. PT IS REPORTEDLY FINE.
METHOD (86): REVIEW OF LOT HISTORY.  RESULTS (100): LOT HISTORY WAS FOUND TO BE ACCEPTABLE.
PATIENT ALLEGES RECEIVING IMPLANTS ON FEB. 25, 1974. MAMMOGRAM PERFORMED ON MAY 2, 1996 SHOWS A NEWLY DEVELOPED LATERAL BULGING WITH DOUBLE DENSITY ALONG THE MARGIN SEEN ON THE CRANIOCAUDED VIEW ON THE LEFT SIDE. POSSIBILITY OF INTRACAPSULAR RUPTURE CANNOT BE EXCLUDED WITH CERTAINTY. PATIENT ALLEGES CONSULTING WITH ORIGINAL PLASTIC SURGEON AND GENERAL PRACTITIONER; BOTH ADVISED REMOVAL OF IMPLANTS. PATIENT HAD REMOVAL ON AUG. 15, 1996.
ABUTMENT BROKE WHILE IN FUNCTION. PT IS REPORTEDLY IN GOOD CONDITION.
METHOD (86): PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DOCTOR.
ON 12/11/89 AN IPP DEVICE WAS IMPLANTED. ON 12/15/95 A CONNECTOR WAS REVISED. ON 7/2/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
ONE OUT OF FOUR IMPLANTS FAILED TO INTEGRATE. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENT TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
AN IPP DEVICE WAS IMPLANTED ON 9/8/87. THE PUMP WAS REVISED ON 5/11/92. THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED ON 7/22/96 DUE TO CYLINDER ANEURYSM.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.'S OFFICE.
THE IPP DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO PUMP FAILURE, CYLINDER FAILURE, AND FLUID LOSS AT RESERVOIR. UNABLE TO OBTAIN ADD'L INFO.
A CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO PAIN.
AN ABUTMENT WAS LOOSE, HE ELECTED TO CUT IT OFF AND WAS UNABLE TO REUSE THE ABUTMENT. PT IS REPORTEDLY FINE.
METHOD:(86) PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DOCTOR.
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT AND REPLACED DUE TO A LEAK IN THE RESERVOIR.
PATIENT ALLEGES BOTH IMPLANTS RUPTURED AND HAD TO BE SURGICALLY REMOVED AND HAVE CAUSED A GREAT DEAL OF SUFFERING, PAIN, EMOTIONAL DISTRESS, FIBROMYALGIA AND NUMEROUS OTHER PROBLEMS. PATIENT ALSO ALLEGES BEING IN SEVERE AND CONTINUING PAIN FROM RUPTURED IMPLANTS. OPERATIVE REPORT STATES PATIENT HAS BEEN COMPLAINING OF SOME PAIN IN HER RIGHT BACK AND SHOULDER AND RIGHT ARM AND ALSO ON THE BACK OF HER NECK AND HEAD. THE PATIENT STATED THAT SHE HAS DEGENERATIVE DISC DISEASE. A MAGNETIC RESONANCE SCAN OF HER CHEST SHOWED A RUPTURE OF BOTH IMPLANTS.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO A TUBING LEAK AT PUMP CONNECTION.
TWO ABUTMENTS BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
METHOD:(86) PARTS NOT RETURNED. LOT NUMBERS NOT AVAILABLE FROM OFFICE.
THE IPP DEVICE WAS REMOVED FROM THE PT AND RPEPLACED DUE TO FLUID LOSS AT CYLINDER.
A SCREW BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
METHOD: (86) PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DOCTOR.
PT RECEIVED IMPLANTS ON 1/2/89. PT ALLEGES IMPLANTS HAVE BUBBLES ON THEM AND SHE IS WAITING FOR REPLACEMENTS. REPORT STATES PT WAS IN A CAR ACCIDENT AND HIT THE STEERING WHEEL AFTER SEAT BUSTED OUT OF BRACKETS. SHE ALLEGES HAVING PROBLEMS BEFORE ACCIDENT, INCLUDING BRUISING, ACHING JOINTS, BREAST STINGING AND BURNING. REPORT ALSO STATES MAMMOGRAM 9/5. IN ADDITION, PT STATES SHE IS CURRENTLY ON ANTI-DEPRESSANT PAXIL AND OUT ON DISABILITY FROM HER JOB. DATE OF EVENT GIVEN IN REPORT IS 12/26/96.
PT STATES SHE IS CURRENTLY ON ANTI-DEPRESSANT PAXIL, AND OUT ON DISABILITY FROM JOB. PT ALSO STATES MAMMOGRAM 9/5. 68 OTHER (NO DEVICE RETURNED)
THE IPP DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION - WASN'T WORKING.
REDUNDANT TUBING WAS MOBILIZED AND BURIED DEEPER IN SCROTUM DUE TO PT DISCOMFORT-TUBING LOOP DISTAL ON PENILE SHAFT-UNCOMFORTABLE FOR PT AND SPOUSE.
THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION-LEFT CYLINDER NOT WORKING.
CYLINDER HAD A WEAR LEAK. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
REPORT ALLEGES THE PT WAS ADMITTED FOR REMOVAL OF BOTH SILICONE BREAST IMPLANTS. SHA HAD A GRADE IV PERI-PROSTHETIC CAPSULAR CONTRACTURE. THE PATHOLOGIST NOTED A STICKY SUBSTANCE ON THE OUTSIDE OF THE IMPLANTS BUT NO OBVIOUS HOLE WAS SEEN.
THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-LEAKING RESERVOIR.
TUBING WAS FUNCTIONAL. RESERVOIR HAD A FATIGUE LEAK.
ON 12/31/92 AN IPP DEVICE WAS IMPLANTED. ON 2/14/96 THE RESERVOIR WAS REVISED. ON 7/30/96 THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-PINHOLE LEAK IN A CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL.
THE PARENTS OF A 10-YR-OLD MALE SPINA-BIFIDA PT ALLEGEDLY RECEIVED A UNIT OF CONTAMINATED (WITH FUNGUS) DURA SUBSTITUTE BOVINE PERICARDIUM. THE PARENTS REPORTED THE INCIDENT BECAUSE THEY HAD HEARD THAT ANOTHER CHILD WHO RECEIVED THE MATERIAL HAD DIED AND YET ANOTHER CHILD HAD THE MATERIAL EXPLANTED. WHEN A PRE-SURGICAL UNIT TESTED POSITIVE, THE EXPLANT WAS NEGATIVE. THE CHILD CONTINUES TO HAVE A LOW GRADE FEVER. THE CHILD HAD BRAINSTEM DECOMPRESSION SURGERY AND WAS ADMINISTERED STEROIDS POST-OP. STEROIDS SUPPRESS THE IMMUNE SYSTEM. ASPERGILLUS IS AN OPPORTUNISTIC ORGANISM IN IMMUNO-COMPROMISED PTS. THE CHILD HAS A CNS SHUNT IMPLANTED; 2 REVISIONS WERE NEEDED POST-OP. THE MFR SAID THEY HAD RECEIVED 2 REPORTS AND DID NOT THINK A PACKAGING PROBLEM COULD LEAD TO A FUNGAL CONTAMINATION DUE TO THE GEOMETRY. THE CO IS MFG THE SAME MATERIAL FOR PERICARDIAL AND VASCULAR REPAIR AND HAS BEEN ENGAGED IN MFG OF THIS MATERIAL SINCE THE 1980S. THEY HAVE IMPLANTED OVER 70,000 UNITS IN THAT TIME. THERE HAVE BEEN NO REPORTS OF SUCH CONTAMINATION, THOUGH THERE HAVE BEEN REPORTS OF LEAKAGE.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO SCROTUM INFECTION WITH SKIN EROSION.
FEEDING PUMP MALFUNCTIONED CAUSING RAPID INFUSION OF FEEDING. 600CC IN 1 HR 15 MINS. PUMP VOLUME INFUSED READ 75CC. FEEDING AND TUBING WERE HUNG ACCORDING TO PROCEDURE.
A BLOOD LEAK OCCURRED DURING DIALYSIS WITH A DIALYZER. DIALYSIS WAS DISCONTINUED AND THE DIALYZER AND BLOOD LINES WERE DISCARDED. ESTIMATED BLOOD LOSS-200 CC'S. BLOOD LOSS WAS THE RESULT OF BLOOD LEFT IN THE DIALYZER AND BLOOD LINES WHEN DISCARDED. NO MEDICAL INTERVENTION OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
PT HAD AN UNICOMPARTMENTAL KNEE PROSTHESIS IMPLANTED ON 01-18-88. IMPLANT WAS REMOVED ON 06-28-96.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES.
TUBING WAS FUNCTIONAL. PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK.
A BLOOD LEAK OCCURRED DURING DIALYSIS WITH DIALYZER. DIALYSIS WAS DISCONTINUED AND THE DIALYZER AND BLOOD LINES WERE DISCARDED. ESTIMATED BLOOD LOSS-200 CC'S. BLOOD LOSS WAS THE RESULT OF BLOOD LEFT IN THE DIALYZER AND BLOOD LINES WHEN DISCARDED. NO MEDICAL INTERVENTION OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
FEEDING TUBE OCCLUDED. REMOVED TUBE AND FOUND THAT TIP WAS DETACHED. X-RAY OF 10/17/94 INDICATED TIP OF FEEDING TUBE PRESENT IN STOMACH AND ALSO INDICATED ONE OR POSSIBLY TWO OTHER TIPS IN LOWER BOWEL.
THE IPP DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CYLINDER HAD A WEAR LEAK.
FLY IN STERILE 3 X 4 DRESSING. NOT USED ON PT.
A BLOOD LEAK OCCURRED DURING THE FIRST FIVE MINUTES OF DIALYSIS WITH DIALYZER. DIALYSIS WAS DISCONTINUED AND THE DIALYZER AND BLOOD LINES WERE DISCARDED. ESTIMATED BLOOD LOSS-250 CC'S. BLOOD LOSS WAS THE RESULT OF BLOOD LEFT IN THE DIALYZER AND BLOOD LINES WHEN DISCARDED. NO MEDICAL INTERVENTION OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
VENTILATOR WENT INTO BACKUP VENTILATION WHILE IN USE. PT WAS PLACED ON ANOTHER VENTILATOR. VENTILATOR WAS TAKEN OUT OF USE UNTIL SVC COMPLETED THE FOLLOWING DAY.
THE PT WAS IMPLANTED WITH SALINE PROSTHESIS ON 5/24/96. ON 5/30/96 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION AND REMOVED THE DEVICE ON 7/26/96. NO ADDITIONAL INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.THE MANUFACTURER WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
ADD'L INFO TO BE SUBMITTED Y.  IS THE EVENT OF EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y.IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N.
A BLOOD LEAK OCCURRED ONE HOUR INTO TREATMENT WITH DIALYZER. DIALYSIS WAS DISCONTINUED AND THE DIALYZER AND BLOOD LINES WERE DISCARDED. ESTIMATED BLOOD LOSS-200 CC'S. BLOOD LOSS WAS THE RESULT OF BLOOD LEFT IN THE DIALYZER AND BLOOD LINES WHEN DISCARDED. NO MEDICAL INTERVENTION OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A LEAK.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK.
A HAIR IN STERILE PRODUCT WAS OBSERVED BY NURSE. DEVICE NOT USED.
THE IPP DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION.
RESIDENT REACHED UP TO USE TRAPEZE. TRAPEZE LET GO AND HIT RESIDENT ON RIGHT SIDE OF FOREHEAD.
THE CYLINDERS WERE REMOVED FROM THE PT DUE TO S-DEFORMITY.
THE RPTR STATED THAT HER HUSBAND, AGE 44, DIAGNOSED AS A TYPE II DIABETIC 20 YEARS AGO, WAS SEEN AT THE ER FOR A PARTIAL BOWEL BLOCKAGE, WHERE A BLOOD GLUCOSE OF 36 WAS OBTAINED WITH A HOSP MONITOR. THE PT WAS TREATED WITH GLUCOSE. THE PT IS ON A SLIDING SCALE (INSULIN R). FOR SEVERAL DAYS PRIOR TO THE INCIDENT, THE RPTR HAD TRIED TO OBTAIN A READING WITH THE SUSPECT DEVICE. AT THE ER, THE DEVICE GAVE "ERROR" FOUR TIMES. COMPARISON DATA OBTAINED AT THE HOSP (TIMING UNKNOWN) GAVE SUSPECT DEVICE 397, LAB 160/SUSPECT DEVICE 495, LAB 134. CONTROLS WERE ACCEPTABLE AFTER THE EVENT. THE RPTR CLAIMS THAT THE PRODUCT CAUSED A DELAY IN THE PT'S TREATMENT BECAUSE IT "READ HIGH".
ALLEGED SYMPTOMS OF AUTOIMMUNE DISEASE AND VARIED INJURIES. FOLLOW-UP FINDINGS: REPORT IS NOT SUBSTANTIATED BY A HEALTH PROFESSIONAL. OUTCOME: UNDETERMINED.
ON 8/14/94 AN IPP DEVICE WAS IMPLANTED. ON 10/17/95 THE CYLINDERS WERE REVISED. INFO RECEIVED ON 8/1/96 INDICATES THE ENTIRE DEVICE WAS REMOVED DUE TO EXTRUSION OF DEVICE IN 1/8/96.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATION. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE.
A PT (HISTORY REQUESTED BUT NOT PROVIDED, EXCEPT THAT PT WAS DEHYDRATED) WAS BROUGHT TO THE HOSP IN A COMA BECAUSE OF INSULIN DOSAGE BASED ON RESULTS FROM THE SUSPECT DEVICE GAVE 130 OR 135 VS. LAB RESULT OF 96.
INFO RECEIVED IN 8/1/96 INDICATES AN IPP DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION, DATE NOT INDICATED. INFO ACQUIRED ON 8/7/96 INDICATES DATE OF SURGERY AS 11/11/95.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CYLINDER HAD OR DAMAGE.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION-TUBING.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDERS HAD OR DAMAGE. TUBING WAS FUNCTIONAL.
ALLEGED SYMPTOMS OF AUTOIMMUNE DISEASE AND VARIED INJURIES.  FOLLOW-UP FINDINGS: REPORT IS UNSUBSTANTIATED BY A HEALTH PROFESSIONAL.  OUTCOME: UNDETERMINED.
ON 7/27/94, AN AUS DEVICE WAS IMPLANTED. ON 2/12/96, A TANDEM CUFF WAS IMPLANTED. ON 7/10/96, THE ORIGINAL CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE, EXPLANTED PROXIMAL CUFF AND IMPLANTED NEW CUFF DISTAL.
AN IPP DEVICE WAS IMPLANTED ON 6/18/93. THE CYLINDERS WERE REVISED ON 3/14/95. INFO RECEIVED ON 8/1/96 INDICATES THE ENTIRE DEVICE WAS REMOVED DUE TO INFECTION, DATE NOT INDICATED. INFO ACQUIRED ON 8/7/96 INDICATES THE DATE AS 5/8/95.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. TUBING HAD OR DAMAGE.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE-FLUID LOSS.
PUMP PERFORMED WITHIN SPECS. CUFF PERFORMED WITHIN SPECS. BALLOON HAD A FATIGUE LEAK.
THE DEVICE WAS REMOVED FROM THE PT DUE TO PT DISCOMFORT.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCIONAL CYLINDER HAD TORN FABRIC AND BULGING.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO A REFLUXATION, LOW COMPLIANCE BLADDER.
PT DEVELOPED INCREASED SPASTICITY AND DID NOT RESPOND TO A BOLUS (100MCG) OF INTRATHECAL BACLOFEN. DEVELOPED TEMPERATURE HIGHER THAN MEASURABLE RANGE, SEVERE REBOUND SPASTICITY AND RHABDOMYOLYSIS. X-RAYS DEMONSTRATED CATHETER DISCONNECTION FROM THE IMPLANTED PUMP. THE CONNECTION BETWEEN THE PUMP AND CATHETER WAS SURGICALLY REPAIRED AND THE THERAPY RESUMED. THE PT WAS REPORTED AS IMPROVING WITH RESUMPTION OF THE THERAPY AND OTHER SUPPORT MEASURES WERE BEING DISCONTINUED AT LAST REPORT.
ALL INFO OBTAINED PER VOLUNTARY REPORTER F4 - UNABLE TO PROVIDE USER FACILITY CONTACT - NO USER FACILITY MEDWATCH RECEIVED - DATE OF EVENT OCCURRED BEFORE MEDWATCH BECAME MANDATORY FOR USERS F6 - IMPOSSIBLE TO DETERMINE WHEN NOT REPORTED BY USER FACILITY F8 - NO USER FACILITY REPORT F10 WAS COMPLETED BY MFR - NO NEW DATA AVAILABLE 4/14/1998: G9 - MFR REPORT NUMBER HAS BEEN CORRECTED HERE AND IN HEADER ON PAGE 1.
ON 8/2/96, THE FACILITY PHARMACIST CONTACTED A MFR NURSE AND REPORTED THAT THE RETURN VOLUME WITH THIS DEVICE HAD DOUBLED IN THE PAST AND BREAKTHROUGH PAIN WAS ALLEVIATED BY INCREASING THE DRUG CONCENTRATION FROM 500MG/50CC TO 700MG/50CC; HOWEVER, LATELY THAT HAS NOT HELPED. THE FACILITY PHARMACIST WAS UNABLE TO SUPPLY THE MFR NURSE WITH SPECIFIC REFILL INFO, DUE TO THE REFILLS BEING CONTRACTED OUT. AT THAT TIME, THE PT WAS IN THE HOSP WITH PNEUMONIA AND WAS SCHEDULED TO BE DISCHARGED TO THE NURSING HOME OR POSSIBLY MOVING TO ANOTHER STATE TO BE WITH HIS DAUGHTER. THE MFR NURSE SUGGESTED A SIDEPORT DYE STUDY BE PERFORMED TO DETERMINE PATENCY AND POSITION OF THE DEVICE CATHETER AND TO RINSE WITH TWO 50CC SYRINGES OF PFNS IN CASE AN AIRLOCK HAS OCCURRED. IN ADDITION, THE MFR NURSE SUGGESTED TO FLUSH THE DEVICE SIDEPORT WITH PFNS TO DETERMINE IF THE DEVICE FLUSHES EASILY. THE FACILITY PHARMACIST INFORMED THE MFR NURSE THAT HE WOULD INFORM THE PHYSICIAN AND SUPPLY THE PHYSICIAN WITH THE MFR'S TELEPHONE NUMBER.
ON 09/20/96, A MANUFACTURER CONTACTED THE FACILITY PHARMACIST FOR ADDITIONAL INFORMATION CONCERNING THIS EVENT. THE FACILITY PHARMACIST INFORMED THE MFR THAT THE PATIENT WENT 52 DAYS WITHOUT A DEVICE REFILL. THE PATIENT WAS SEEN ON 9/10/96, AT WHICH TIME, THE DEVICE HAD 2CC REMAINING IN THE DEVICE RESERVOIR. ALSO, ON 9/10/96, THE FACILITY NURSE WAS PRESENT AND THE DEVICE WAS FLUSHED TWICE WITH 50CC OF SALINE. THE FIRST DEVICE FLUSH HAD A  RETURN VOLUME OF 50CC; HOWEVER, THE SECOND DEVICE FLUSH RETURNED 52CC. AT THIS TIME, THE DEVICE FLOW RATE IS .96ML/DAY. THE PATIENT WAS SCHEDULED TO RETURN IN 25 DAYS ON 10/04/96. THE PHYSICIAN MAY INCREASE THE DRUG CONCENTRATION TO ALLEVIATE THE PATIENT'S BREAK-THROUGH PAIN. THE FACILITY PHARMACIST STATED THAT THERE WAS TALK OF PRESCRIBING PERCOCET; HOWEVER, HE DOES NOT BELIEVE THIS WILL BE STRONG ENOUGH. IN ADDITION, THE FACILITY PHARMACIST INFORMED THE MFR THAT THE PATIENT HAS A SMALL, CIRCULAR BUMP, THAT IS NOT RED AND THE PATIENT DOES NOT COMPLAIN OF PAIN IN THAT AREA. THE FACILITY PHARMACIST BELIEVES IT MAY BE A CYST AND THE MFR QUESTIONED IF HE THOUGH IT MIGHT BE THE DEVICE SIDEPORT. HOWEVER, THE FACILITY PHARMACIST STATED THAT ACCORDING TO THE DIAGRAM THE DEVICE SIDEPORT IS LOCATED AT THE 7 O'CLOCK MARK AND THE "BUMB" IS LOCATED AROUND THE 4 O'CLOCK MARK. THE FACILITY PHARMACIST ALSO INFORMED THE MFR THAT HE HAS NEVER ACTUALLY SEEN ONE OF THESE DEVICES. THE MFR REQUESTED THAT THE FACILITY PHARMACIST ALSO INFORMED THE MFR THAT HE HAS NEVER ACTUALLY SEEN ONE OF THESE DEVICES. THE MFR REQUESTED THAT THE FACILITY PHARMACIST CONTACT THE MFR AFTER THE NEXT DEVICE REFILL. IN ADDITION, THE MFR IS ATTEMPTING TO SCHEDULE A CLINICAL REP TO BE PRESENT AT THE NEXT DEVICE REFILL SCHEDULED FOR 10/4/96.
THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO INFECTION.
THE CUFF AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE-ATROPHY UNDER THE CUFF AND AIR IN THE SYSTEM.
PUMP PERFORMED WITHIN SPECS. CUFF HAD OR DAMAGE.
THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS-CYLINDERS.
FACILITY HAD A PT WITH A KNOWN LATEX ALLERGY AND WAS TRYING TO FIND A BRAND OF STERILE GLOVES THAT WERE LATEX-FREE TO BE USED IN SURGERY. THIS MFR'S PRODUCT DID NOT STATE LATEX ANYWHERE IN THE PACKAGING SO THE HOSP CALLED THE MFR TO VERIFY THE GLOVES CONTENTS. MFR TOLD THE USER THAT THERE WAS IN FACT LATEX IN THE GLOVES. HAVING NO OTHER ALTERNATIVE THE MD PRE-MEDICATED THE PT WITH AN ANTIHISTAMINE AND USED THE GLOVES DESPITE THEIR CONTENT. THE FACILITY IS CONCERNED ABOUT CURRENT LABELING PRACTICES IN LIGHT OF RECENT AWARENESS OF LATEX SENSITIVITY. THEIR FIRST CONCERN IS THE SEEMING POOR AVAILABILITY OF STERILE LATEX-FREE GLOVES AND THEIR SECOND CONCERN IS THE OBVIOUS POTENTIAL FOR PT HARM IF GLOVES ARE NOT CLEARLY LABELED AS CONTAINING LATEX. THIS PARTICULAR PT DID NOT SUSTAIN ANY ADVERSE REACTION.
THE DEVICE WAS REMOVED FROM THE PT DUE TO BEING UNABLE TO INFLATE.
ON 11/21/83, AN AUS DEVICE WAS IMPLANTED. ON 11/27/91, THE BALLOON AND PUMP WERE REVISED. ON 7/9/96 THE CUFF WAS REVISED. ON 7/25/96, THE CUFF AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO THE TUBING BEING DISCONNECTED FROM THE CUFF TO THE PUMP.
PUMP WAS NOT FUNCTIONALLY TESTED. CUFF PERFORMED WITHIN SPECS.
THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS.
A SINGLE CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
THE DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO FLUID LOSS.
79 YEAR OLD, WHO HAD IN 1994 UNDERWENT REVISION HIP ARTHROPLASTY. PRESENTS NOW WITH PAIN, DISCOMFORT & ROENTGENOGRAPHIC EVIDENCE OF DISLOCATION. CONSTRAINING RING WAS FRACTURED. THERFORE HIP REVISION COMPLETED.
ON 8/5/96, WHILE IN THE OPERATING ROOM WITH THE PT, THE SURGEON CONTACTED A MFR REPRESENTATIVE AND STATED THAT THE DEVICE SIDEPORT SEPTUM IS "DISLODGED FROM THE DEVICE AND LYING IN THE SIDEPORT AT A 90 DEGREE ANGLE." "BLOOD HAS BEEN LEAKING FROM THE DEVICE SIDEPORT". THE DEVICE WAS IMPLANTED WITHIN THE HEPATIC ARTERY, ON 7/9/96, FOR TREATMENT OF LIVER CANCER. A METHYLENE BLUE PERFUSION SCAN WAS PERFORMED WHICH CONFIRMED ADEQUATE PERFUSION TO BOTH LOBES OF THE LIVER. THE DEVICE WAS ACCESSED SATISFACTORILY ON 7/12/96. THE PT WAS DISCHARGED FROM THE HOSP ON 7/17/96. ON 7/19/96, THE PT WAS SEEN BY THE PHYSICIAN WITHOUT ANY DIFFICULTIES NOTED. ON 7/22/96, THE PT WAS SEEN BY THE ONCOLOGIST AND SEROMA/HEMATOMA WAS NOTED. THE PHYSICIAN DRAINED 400CC'S OF FLUID FROM THE DEVICE POCKET SITE ON 7/29/96. ON 7/30/96, THE ONCOLOGIST WAS UNABLE TO ACCESS THE DEVICE DUE TO A LARGE HEMATOMA. ON 8/2/96 THE HEMATOMA WAS STILL PRESENT. THE PT WAS SCHEDULED FOR INSERTION AND DRAINAGE AT ANOTHER FACILITY ON 8/5/96. UPON OPENING THE DEVICE POCKET, THE SURGEON WAS ABLE TO VISUALIZE THE SIDEPORT DISLODGMENT. AS A RESULT, THE DEVICE WAS EXPLANTED. A NEW DEVICE WAS ORDERED AND SURGERY SCHEDULED FOR 8/6/96 FOR IMPLANT OF THE REPLACEMENT DEVICE. A MFR NURSE CONTACTED BOTH PHYSICIANS' OFFICES ON 8/5/96 AND CONFIRMED THAT THE DEVICE HAD NOT BEEN ACCESSED IN EITHER OF THEIR OFFICES.
INITIAL VISUAL INSPECTION REVEALED THAT THE DEVICE SIDEPORT SEPTUM WAS PARTIALLY DISLODGED UPON RECEIPT. AFTER RE-SEATING THE DEVICE SIDEPORT SEPTUM, NORMAL USAGE WAS INDICATED ON BOTH THE CENTER AND SIDEPORT SEPTA WITH NO INTERNAL FRACTURE PLANE DAMAGE FOUND. THE DEVICE SIDEPORT WAS PATENT UPON FLUSHING AND APPROX. 5 ML OF CLOUDY, YELLOW FLUID WITH AMBER COLORED PARTICLES WAS COLLECTED WHICH TESTED POSITIVE FOR BLOOD WAS FOUND IN THE DEVICE CAPILLARY TUBE FLOWPATH. AFTER REMOVING APPROX. ONE HALF OF THE DEVICE CAPILLARY TUBING, PATENCY WAS RESTORED AND THE DEVICE FLOWED 189% OF THE ORIGINAL MANUFACTURED FLOWRATE. LEAK TESTING CONFIRMED THE DEVICE DID NOT LEAK. NO OTHER DEFECTS OR ANOMALIES WERE FOUND DURING ANALYSIS. AS PART OF CO'S INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISOTRY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MANUFACTURING VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THIS ANALYSIS HAS CONFIRMED THE SURGEON'S COMPLAINT OF "SEPTUM DISLODGEMENT". OVERPRESSURIZATION IS SUSPECTED TO BE ATTRIBUTABLE TO THE SEPTUM DISLODGEMENT; HOWEVER, THE PRECISE CAUSE OF THE SEPTUM DISLODGEMENT CANNOT BE CONCLUSIVELY DETERMINED BO CO'S ANALYSIS. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
THE FOOT PEDALS ORDERED WERE DIFFERENT FROM WHAT WAS RECEIVED. THAT WAS RESOLVED WITHIN SEVERAL WEEKS. HOWEVER, WHEN THE PT CAME ACROSS AN OBSTRUCTION, SAY A SIDEWALK CURB, THE OBSTRUCTION WOULD FORCE THE LEG RESTS UP AND OFF THEIR STEMS AND THE LEG RESTS WOULD SWING OUT PUTTING THE JOINTS OF HIS LEGS INTO A VERY STRAINED POSITION. AT ONE POINT IT ALMOST CAUSED A BREAK IN THE LEG BONE; INSTEAD IT WAS JUST A SEVERE SPRAIN IN THE KNEE. THERE IS NO LOCKING MECHANISM WHERE THE LEG REST ATTACHES TO THE FRAME OF THE WHEELCHAIR TO PREVENT IT FROM BEING PUSHED UP AND AWAY OR OFF COMPLETELY. THE FRONT WHEEL CASTERS WERE DESIGNED TO BE LIGHTWEIGHT. BUT INSTEAD, THEY COLLAPSED AND ACTUALLY BROKE. RPTR HAS BEEN IN TOUCH WITH THE MFR ABOUT THESE PROBLEMS. MFR'S REMEDIES ARE: 1. TO REPLACE THE FRONT WHEELS WITH THE EXACT SAME KIND OF FRONT WHEELS THAT COLLAPSED BEFORE, AT NO CHARGE. ANYTHING STRONGER OR BIGGER WILL COST AN ADD'L CHARGE. 2. THEY ARE WILLING TO MAKE A LOCKING SYSTEM TO CORRECT THE PROBLEMS WITH THE LEG RESTS AND CHARGE HIM $48./HR FOR THE LABOR INVOLVED TO MAKE SUCH A LEG REST LOCK. (*)
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE CUFF WOULD NOT INFLATE.
IMPLANTED ON 7/20/94. REVISION SURGERY WAS PERFORMED ON 7/20/96, DUE TO FRACTURE OF LINER AND RING.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
RESULTS OF A CAPILLARY SPECIMEN TESTED ON DEVICE ARE UNACCEPTABLY HIGH WHEN COMPARED WITH A SIMULTANEOUS VENOUS SPECIMEN. THIS HAS THE POTENTIAL FOR ALLOWING RPTR TO ACCEPT DONORS WHO WOULD OTHERWISE BE DEFERRED ON THE BASIS OF A LOW HEMOGLOBIN. (*)
PT REPORTED THAT IV POLE, WHICH HAD BEEN SECURED AT BEDSIDE, FELL ONTO HER HEAD. NO ADVERSE PT EFFECT.
THE DR EXPERIENCED A SCLERAL BURN ON ONE PT DURING A ROUTINE PHACOEMULSIFICATION PROCEDURE. THE DR INDICATED THAT HE THOUGHT THE TIP MAY HAVE OCCLUDED. THE PT IS EXPECTED TO RECOVER FULLY.
INFO RECEIVED ON 11/11/96 INDICATED THE CUFF WAS REMOVED ON 5/17/96 AND NOT REPLACED.
THE TITANIUM FEMORAL ROD WAS INSERTED IN THE PT WHILE HE WAS A PT AT THE CENTER. SIX MONTHS LATER, THE PT PRESENTED TO A COMMUNITY HOSP AND WAS DIAGNOSED WITH A FRACTURED ROD. THE ROD WAS REPLACED.
IMPLANT WAS PLACED ON 2/7/96 AND REMOVED 3/5/96. PT SMOKES 1 1/2 PACKS A DAY.
PACEMAKER GENERATOR ERODED THRU SKIN ON RIGHT CHEST WALL. PT WITH CHRONIC DERMATITIS WITH SEVERE SCRATCHING OVER SITE. ACCORDING TO SURGEON IMPLANTED 12/95. REMOVED 7/24/96.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE AND EROSION.
THAT SOMETIME PRIOR TO 8/27/94, THE PLAINTIFF/DECEDENT DID WITH CARE PURCHASE AND THIS PLAINTIFF DID DELIVER A RESPIRATOR-LIKE DEVICE TO ASSIST THIS PLAINTIFF/DECEDENT IN BREATHING. THAT ON 8/27/94, THIS DEVICE MALFUNCTIONED DUE TO A DETECT THAT ALLOWED A TRACH MASK, OXYGEN ADAPTER AND OTHER TUBING MFG AND/OR MARKETED BY ONE OR ALL OF THE REMIANING DEFENDANTS TO BECOME DISCONNECTED AND THEREBY DID DIRECTLY AND PROXIMATELY CAUSE THE DEATH OF THE PLAINTIFF/DECEDENT.
SECTION F COMPLETED BY CO. REPORT RECEIVED VIA LITIGATION. NO OTHER INFO AVAILABLE.
THE AUS DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION
THE PACEMAKER GENERATOR ERODED THROUGH THE SKIN ON THE RIGHT CHEST WALL. THIS PT HAS CHRONIC DERMATITIS WITH SEVERE SCRATCHING OVER THE SIGHT. ACCORDING TO THE SURGEON, THE DEVICE WAS IMPLANTED 12/95 AND REMOVED 7/24/96.
REFERENCE D.6 OF THIS FORM FOR THE REQUESTED INFO.
THE AUS DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS AT PUMP.
PUMP TUBING JUNCTION HAD A FATIGUE AND WEAR LEAK CUFF PERFORMED WITHIN SPECIFICATIONS. ORIGINAL PRESSURE OF BALLOON UNKNOWN.
EXTERNAL INFECTION OCCURRING AT THE SITE OF THE SUBCUTANEOUS CUFF OF THE PERITONEAL CATHETER WAS TREATED BY EXCISING THE UNFECTED SKIN. THE CUFF WAS FREED FROM THE SKIN AND THE BULK OF THE CUFF MATERIAL WAS REMOVED. THE CATHETER WAS ANCHORED TO THE INTACT AREA OF THE SKIN WITH NYLON SUTURES. PRIOR TREATMENT OF THE INFECTION WITH ANTIBIOTICS AND CLEANSING THE SITE DID NOT ELIMINATE THE INFECTION, WHICH BECAME CHRONIC.
INFO GIVEN IN SECTION F WAS OBTAINED FROM CO RECORDS. CO HAS SOLICITED THE INFO FROM THE CONTACT PERSON BY LETTER, PHONE AND FAX. CO HAS RECEIVED NO MORE INFO FROM CONTACT.
THE AUS DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION.
PT FELL ON HIS BACK TWO STORIES TO THE GROUND AND WAS ADMITTED WITH COMPRESSION FRACTURE TO T12. PT COMPLAINED OF CONTINUED PAIN AND HAD SURGERY ON DOWN LEFT LEG. HAD SECOND SURGERY ON 6/25 TO REMOVE HOOK. LEG PAIN ASSESSED AND APPEARS TO BE SECONDARY TO NERVE ROOT IRRITATION.
THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO AUTOMATIC-DEFLATION-WOULD NOT STAY PUMPED UP.
THE DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO MALFUNCTION. CO HAS REQUESTED ADDITIONAL INFORMATION.
CYLINDER PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS.
ADDITIONAL INFORMATION RECEIVED ON 4/8/97 INDICATES THE DYNAFLEX DEVICE WAS REMOVED FROM THE PATIENT AND AN IPP DEVICE IMPLANTED.
THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO A RIGHT CYLINDER FLUID LOSS.
CYLINDER HAD A WEAR LEAK.CYLINDER PERFORMED WITHIN SPECS.
CYLINDER HAD A WEAR LEAK.CYLINDER HAD A WEAR LEAK.
AN AUS DEVICE WAS IMPLANTED DATE NOT INDICATED. ON 6/13/96 THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION.
PUMP PERFORMED WITHIN SPECS.CYLINDER PERFORMED WITHIN SPECS.CYLINDER PERFORMED WITHIN SPECS.
CYLINDER HAD OR DAMAGE.CYLINDER HAD OR DAMAGE.PUMP PERFORMED WITHIN SPECS.
THE DEVICE WAS REMOVED FROM THE PT AND AN IPP DEVICE IMPLANTED DUE TO IT NOT INFLATING.
CYLINDER PERFORMED WITHIN SPECS.PUMP PERFORMED WITHIN SPECS.CYLINDER HAD A FATIGUE LEAK.
X-TUBE ASSM 17" X 15". DEALER CLAIMS X-TUBE BROKEN AT WELD.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, IN., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE GLOVES CAUSED A SYSTEMIC REACTION. USER EXPERIENCED UPPER RESPIRATORY DISTRESS AND HIVES ON HER HANDS. SHE IS ALLERGIC TO ANY KIND OF LATEX GLOVES.
ALLEGATIONS OF SCLERODERMA LIKE SYNDROME, ATYPICAL CONNECTIVE TISSUE DISEASE, ATYPICAL NEUROLOGIC DISEASE, RHEUMATOID ARTHTRITIS, DERMATOMYOSITIS, SJOGREN'S SYNDROME, NONSPECIFIC AUTOIMMUNE CONDITION, POLYARTHRITIS, KERATOCONJUNCTIVITIS SICCA, MYALGIAS, NEUROPSYCHIATRIC, PERIPHERAL NEUROPATHY, CHRONIC FATIGUE, ALOPECIA, SLEEP DISTURBANCES, DIZZINESS, COLITIS OR BOWEL IRRITABILITY, CHRONIC INFLAMMATORY RESPONSE, BREAST INFECTION, DISFIGUREMENT, IMPAIRMENT OF THE IMMUNE SYSTEM, COMPLEX SURGICAL PROCEDURES, SCAR TISSUE CAPSULATION, AUTOIMMUNE DISEASE, MEMORY LOSS, SKIN DISCOLORATION, LOSS OF CONCENTRATION, HUMAN ADJUVANT DISEASE,  DEPRESSION, SILICONE TOXITY SYNDROME, SILICONE IMPLANT DISEASE.
ALLEGATIONS OF SCLERODERMA, SJOGREN'S SYNDROME, HAIR LOSS, COGNITIVE DYSFUNCTION, MYALGIAS, ARTHRALGIAS, CHRONIC FATIGUE, OBSTRUCTIVE AIRWAY  DISEASE.
X-TUBE ASSM 18" X 18". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, IN.C. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
A PT WAS TREATED ON 7/19/96 INTO THE FOREHEAD, GLABELLA AND LATERAL LAUGH LINES. ON 8/21/96, SHE DEVELOPED REDNESS, SWELLING AND ITCHING AT ALL TREATMENT SITES. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY AND PRESCRIBED MEDROL DOSPAK, BENADRYL, AND ELOCON CREAM.
ON 21 APRIL 1998, THE PHYSICIAN REPORTED THAT THE PT WAS LAST SEEN ON 30 APRIL 1997. THE SYMPTOMS RESOLVED ON 30 APRIL 1997.
X-TUBE ASSM 16" X 15". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT HOLE LOCATION.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BUY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT DEVELOPED COMPLETE HEART BLOCK DURING PTCA PROCEDURE FOR RIGHT INFERIOR BLOCKAGE. DURING PLACEMENT OF THE CATHETER, THE RIGHT VENTRICULAR WALL WAS PERFORATED, RESULTING IN CARDIAC TAMPONADE. TAMPONADE WAS TREATED EMERGENTLY WITH MEDIAN STERNOTOMY TO REMOVE THE CATHETER AND REPAIR THE VENTRICULAR WALL.
X-TUBE ASSM 18 X 16. DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BU QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPROTABLE EVENT.
DURING AN EMERGENT CORONARY ANGIOPLASTY PROCEDURE, AN ANGIOPLASTY BALLOON CATHETER FAILED. THE PT HAD BEEN ADMITTED WITH A MYOCARDIAL INFARCTION AND UNDERWENT CATHETERIZATION WHICH SHOWED SEVERE TRIPLE-VESSEL CORONARY ARTERY DISEASE. THE CARDIOLOGIST PLACED A 3.5 MM STENT IN THE PT'S PROXIMAL LAD FOLLOWED BY A 0.014 INCH GUIDE WIRE AND A 2.5 MM BALLOON INTO THE SECOND CIRCUMFLEX MARGINAL OF THE LAD. INFLATIONS WERE PERFORMED AT RELATIVELY LOW PRESSURES (5-7 ATM). WHEN THE CARDIOLOGIST ATTEMPTED TO WITHDRAW THE BALLOON, HE ENCOUNTERED FIXED RESISTANCE AT THE CIRCUMFLEX OSTIUM. NUMEROUS UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE BALLOON. AFTER TWO HRS AND JUST BEFORE IT WAS DECIDED TO ATTEMPT HIGH-RISK EMERGENCY BYPASS SURGERY, A FINAL ATTEMPT TO WITHDRAW THE CATHETER WAS SUCCESSFUL. INSPECTION OF THE DEVICE BY THE CARDIOLOGIST DISCLOSED A FRACTURE IN THE CATHETER SHANK JUST PROXIMAL TO THE ANGIOPLASTY BALLOON, WITH STIFF FRAGMENTS OF TUBING AND WIRE PROTRUDING FROM THE FRAYED SHANK. FOLLOW-UP ANGIOPLASTY SHOWED A DIVOT IN THE PROXIMAL CIRCUMFLEX, APPARENTLY CAUSED BY STIFF CATHETER COMPONENTS THAT DUG INTO THE ARTERIAL WALL. FOLLOWING THE INITIAL ANGIOPLASTY, THE PT SUFFERED A FOUR UNIT GASTROINTESTINAL HEMORRHAGE. TWO DAYS LATER, THE PT DEVELOPED ISCHEMIC PULMONARY EDEMA AND UNDERWENT ANGIOPLASTY OF THE FIRST CIRCUMFLEX MARGINAL BRANCH, COMPLICATED BY CORONARY PERFORATION AND ACUTE CARDIAC TAMPONADE RELIEVED BY PERICARDIOCENTESIS. THE PT EVENTUALLY RECOVERED IN THE CCU AND WAS DISCHARGED IN GOOD CONDITION ON 7/13/96. THREE DAYS LATER, THE PT COLLAPSED AT HOME AND WAS TAKEN TO ANOTHER LOCAL EMERGENCY ROOM (HOSP UNK). UPON ARRIVAL, SHE WAS COMATOSE, WITH HYPOTENSION, COMPLETE HEART BLOCK AND AN AGONAL ESCAPE RHYTYM. RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL AND SHE WAS PRONOUNCED DEAD. THE CARDIOLOGIST BELIEVES THAT THE DEATH WAS LIKELY CAUSED BY LEFT/MAIN CIRCUMFLEX THROMBOSIS AS A RESULT OF THE INITIAL DEVICE FAILURE. THE CARDIOLOGIST RETURNED THE DAMAGED BALLOON CATHETER TO THE MFR FOR FAILURE ANALYSIS. THE MFR'S ANALYSIS INDICATES THAT THE BALLOON AND CATHETER SHAFT WERE TORN AND THAT THE CORE WIRE HAD COME LOOSE FROM ITS MOST DISTAL END AND WAS EXPOSED. THEY WERE UNABLE TO DETERMINE THE EXACT CAUSE OF THE DAMAGE TO THE CATHETER.
AIR OBSERVED IN ARTERIAL LINE AT FIELD, DURING OPEN HEART SURGERY WITH PROBABLE AIR INADVERTENTLY INJECTED OR PUMPED INTO THE AORTA.
A PT WAS TREATED ON 2/26/96 WITH TWO FORMULATIONS OF COLLAGEN INTO PERIORBITAL LINES AND THE NASOLABIAL FOLDS. IN 4/96 (EXACT DATE UNKNOWN), THE PT NOTED "RED LUMPS" AT THE PERIORBITAL TREATMENT, SITES. IN 5/96 (EXACT DATE UNAVAILABLE) THE PT PRESENTED WITH ERYTHEMA, SWELLING, AND INDURATION AT THE PERIORBITAL TREATMENT SITES. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY AND PRESCRIBED ORAL CLARITIN. ON 7/19/96, THE PT PRESENTED WITH PERSISTENT SYMPTOMS; ORAL PREDNISONE WAS PRESCRIBED. ON 8/12/96, THE PT PRESENTED WITH PERSISTENT SYMPTOMS; ORAL SELDANE WAS PRESCRIBED. THE PHYSICIAN ALSO REPORTED THAT IN 8/96 (EXACT DATE UNKNOWN), THE PT NOTED HAIR LOSS, WHICH WAS ATTRIBUTED TO CHEMICAL PROCESSING OF THE PT'S HAIR.
ON 3/19/97, FOLLOW UP INFO WAS RECEIVED FROM THE PHYSICIAN. THE PATIENT WAS SEEN ON 10/8/96; THE HYPERSENSITIVITY SYMPTOMS RESOLVED ON 8/12/96.
OR AXLE MAG WITH NUT. DEALER CLAIMS THAT THE BALLS ARE OUT OF THE QUICK RELEASE AXLE AND THAT IT WILL NOT STAY IN CHAIR WITHOUT THESE.
A 3 Y/O WITH COMPLEX CONGENITAL CARDIAC DISEASE UNDERWENT A FONTAN PROCEDURE ON 7/15/96. DEVELOPED RENAL FAILURE S/P SURGERY AND REQUIRED CVVH. ON 7/29/96 AT 7:45 PM PRESSURE ALARMS CONTINUED TO ALARM, AND AT 8:40 PM, CO'S 800# FOR TECHNICAL ASSISTANCE WAS ACCESSED. STAFF ADVISED TO REMOVE UNIT. OTHER UNIT IS WITH CO SINCE APRIL FOR REPAIRS. AT 3:53 AM ON 7/30, PT PRONOUNCED, HAD VENTRICULAR DYSRHYTHMIAS REFRACTORY TO TREATMENT.
X-TUBE ASSM 20" X 16". DEALER CLAIMS X-TUBE BROKE.
TIP OF NEEDLE BROKE OFF DURING SURGERY. UNABLE TO FIND OR RETRIEVE APPROX 0.5 CM TIP OF NEEDLE.
DURING A CORE VITRECTOMY, ASSOCIATED WITH A RETINAL ATTACHMENT  PROCEDURE, CHOROIDAL BALLOONS FORMED ON THE NASAL SIDE OF THE RETINA; CHOROIDAL EFFUSION DEVELOPED. THE PHYSICIAN INVOLVED BELIEVES THAT THIS CONDITION WAS CAUSED BY INSUFFICIENT INTRAOCULAR PRESSURE DURING THE PROCEDURE. PRESSURE WAS DELIVERED TO THE OPERATIVE SITE BY A MICRO SURGICAL SYSTEM THROUGH DISPOSABLE SURGICAL TUBING. THE MICRO SURGICAL SYSTEM WAS EVALUATED AND FOUND TO BE FUNCTIONING PROPERLY. THE TUBING INVOLVED IN THE PROCEDURE WAS DISCARDED, AND WAS THEREFORE UNAVAILABLE FOR EVALUATION. THE FACILITY BELIEVES THAT THE TUBING COULD HAVE COME FROM EITHER OF THE TWO LOTS REFERENCED ABOVE. THE ATTENDING PHYSICIAN INDICATED THAT THE CONDITION, CHOROIDAL EFFUSION, CORRECTS ITSELF. THE FACILITY HAS INDICATED THAT FOUR SIMILAR EVENTS HAVE OCCURRED, ONE OF WHICH MAY HAVE RESULTED IN PT INJURY.
A REVIEW OF THE DOCUMENTATION ASSOCIATED WITH THESE LOTS AND DID NOT REVEAL ANY CONDITION OR OBSERVATION RELATED TO TE REPORTED EVENT. AS SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION THE REPORTED MALFUNCTION COULD NOT BE CONFIRMED.
X-TUBE ASSM 18" X 15". DEALER CLAIMS X-TUBE BROKE.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESINGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING CARDIAC CATH PROCEDURE, #6 FRENCH PIGTAIL CATHETER APPEARED TO BE KINKED. UPON WITHDRAWING CATHETER, THE TIP WAS DISLODGED. A SNARE WAS PLACED AND THE TIP WAS RETRIEVED. PIECES WERE RETURNED TO MFR. NO SERIOUS ILLNESS/INJURY TO PT WAS INCURRED.
X-TUBE ASSM 16" X 16". DEALER CLAIMS X-TUBE BROKE WHILE CUSTOMER WAS GOING OFF CURB ON 6/9/96. BROKEN AT CENTER PIVOT HOLE.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OR THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
LENS (IOL) WAS IMPLANTED IN 1982. PT PRESENTED WITHH UVEITIS AND IRITIS CAUSED BY IRIS CHAFING, DUE TO SUBLUXATION CAUSED BY ZONULAR DISINSERTION AND HAPTIC POSITIONING. THE PHYSICIAN GIVES THE DATE OF THE EVENT AS 6/96. PT WAS TREATED WITH TOPICAL CORTICOSTEROIDS AND ANTIBIOTICS. THE SUSPECT LENS WAS REMOVED AND REPLACED WITH ANOTHER IOL. THE PT PROGNOSIS IS EXCELLENT.
LENS AND HAPTICS SHOW DAMAGE CAUSED BY PROBABLE OVER HANDLING; THIS IS UNRELATED TO THE REPORTED ADVERSE EVENT.
DURING ADENOIDECTOMY WITH RED RUBBER CATHETER PLACED THROUGH NOSE FOR RETRACTION OF OROPHARYNX, FLAMES WERE NOTED IN ORAL CAVITY DURING CAUTERIZATION. WATER WAS PLACED IN MOUTH TO DIFFUSE FLAMES. DR PERFORMED EXAM OF NOSE AND OROPHARYNX AS WELL AS BRONCHOSCOPY AND REPORTED CHARING OF NASAL PASSAGES.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SIBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT NOTED TO HAVE ABRASION IN MIDDLE OF FOREHEAD. PT MONITORED IN HOSP WITH PULSE OXIMETER PLACED ON FOREHEAD AND SECURED WITH THE HEAD BAND. SHAPE OF PROBE RESEMBLES THAT OF SCAR. ABRASION HEALED BUT DEEP SCAR REMAINED. INJURY MAY HAVE BEEN CAUSED BY PRESSURE FROM PROBE.
TUBING CONNECTED TO HEART LUNG MACHINE BACKWARDS ALLOWING AIR TO BE PUMPED TO PT. NO PREVENTION MECHANISM BUILT INTO TUBING. NEW PROCEDURE IMPLEMENTED TO PREVENT FUTURE EVENTS: TUBING END TO BE IMMERSED IN WATER BEFORE ATTACHING TO PT.
ON 8-1-96, NPB RECEIVED A MEDWATCH REPORT THAT A PATIENT ADMITTED TO THE INTENSIVE CARE UNIT ON 3 APRIL 1996 FOR A GI BLEED WAS BEING MONITORED WITH A PULSE OXIMETER AND A NELLCOR MODEL RS-10 REFLECTANCE OXYGEN TRANSDUCER. THE HOSP HAS INDICATED THAT THE SITE OF APPLICATION MAY NOT HAVE BEEN CHANGED FOR APPROX 36 HOURS (AGAINST THE RS-10'S DIRECTIONS FOR USE). THE PATIENT WAS REPORTED TO BE PUT IN TRENDELENBURG'S POSITION FOR "ATLEAST TWO HOURS" (ALSO AGAINST THE RS-10'S DIRECTIONS FOR USE). ALLEGEDLY, ON 5 APRIL 1996, AN ABRASION WAS NOTED IN THE AREA ON THE FOREHEAD WHERE THE RS-10 HAD BEEN APPLIED. REPORTEDLY, THE ABRASION HEALED WITHOUT MEDICAL INTERVENTION. IN JUNE, 1996, THE PT VISITED HER PHYSICIAN AND A "FISHTAIL" SHAPED SCAR REPORTED TO BE APPROX 2 MM DEEP WAS OBSERVED ON HER FOREHEAD. THE HOSP HAS STATED THAT THEY HAVE NOT BEEN ABLE TO ISOLATE THE PULSE OXIMETER THAT HAD BEEN IN USE AT THE TIME. THE HOSP CLAIMS TO HAVE DISCARDED THE RS-10 AND THAT THE LOT NUMBER COULD NOT BE IDENTIFIED. THE RS-10 DIRECTIONS FOR USE CLEARLY WARNS; "THE RS-10 CAN BE USED ON THE SAME SITE FOR UP TO 4 HOURS. HOWEVER, THE SENSOR SITE MUST BE INSPECTED ROUTINELY TO ENSURE SKIN INTEGRITY AND CORRECT POSITIONING AND ADHESION OF THE SENSOR. IF SKIN INTEGRITY CHANGES, MOVE THE SENSOR TO ANOTHER SITE." AND; "DO NOT USE THE RS-10 IF THE PATIENT IS IN TRENDELENBURG'S POSITION (HEAD LOWER THAN HEART) AND/OR ON A MECHANICAL VENTILATOR." THE HOSP HAS STATED THAT THEY "HAVE UNDERTAKEN A SIGNIFICANT EDUCATIONAL PROGRAM" REGARDING THIS EVENT. NPB HAS OFFERED IN SERVICE ASSISTANCE AS WELL AS EDUCATIONAL MATERIALS TO THIS CUSTOMER.
PT FOUND ON THE FLOOR IN BATHROOM. DEVICE WAS IN USE. DID NOT ALARM TILL NURSE FOUND PT ON FLOOR. DEVICE (SENSOR PAD) CHECKED BY BIOMED AND FOUND DEFECTIVE. ALL SENSOR PADS IN INVENTORY FOUND DEFECTIVE. PT SUFFERED MINOR LACERATION.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CAUTERIZING TIP OF THE INSTRUMENT BROKE OFF INSIDE THE PT. THE TIP WAS RETRIEVED DURING THE PROCEDURE. THE HOSP HAS REPORTED NOT PT INJURY OCCURRED.
1/27/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. THE FOLLOWING INFO HAS BEEN INDICATED AS REQUESTED: D-6,D-7, & D-8.
THE SERVICE REPORT SHOWS THAT THE VENT HAD FAILED THE EXTENDED SELF TEST. THE CO CUSTOMER SUPPORT ENGINEER VERIFIED THE CONDITION AND FOUND EXHALATION CHECK VALVE KINKED OR FOLDED IN HALF. THE CSE INSPECTED THE DEVICE AND UPGRADED THE VENT FROM A FRONT LOADING FILTER COMPARTMENT TO A BOTTOM LOADING FILTER COMPARTMENT. THE UNIT PASSED EXTENDED SELF TESTING AND PERFORMANCE VERIFICATION TESTING.
BASED UPON INFO IN OUR POSSESION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
ON 6/13/95, AN AUS DEVICE WAS IMPLANTED. ON 8/1/95, THE BALLOON AND PUMP WERE REVISED. ON 4/25/96, THE CUFF WAS REMOVED FORM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
DURING A PTCA PROCEDURE A HOLE WAS NOTED TO BE IN THE BALLOON OF THIS DEVICE. THE BALLOON WAS PULLED BACK, AND A DISSECTION OCCURRED. THE PT WAS STENTED, HOWEVER, THE ARTERY WAS TOTALLY CLOTTED. IT IS UNKNOWN AT THIS TIME IF FURTHER SURGERY WILL BE REQUIRED.
#1333 LABELED. #1628 NOT LABELED FOR "HOLE IN BALLOON" HOWEVER, DEVICE IS LABELED TO USE CATHETER PRIOR TO THE "USE BEFORE" DATE (EXPIRATION DATE) SPECIFIED ON THE PACKAGE.
PT WAS BEING TRANSFERRED TO TCS BY THE NURSE, WHEN SHE SLIPPED OFF AND DID THE SPLITS. PT WAS SHOCKED BUT UNHURT.
THIS IS A CLOSE OUT BY THE FOREIGN REPORTER. INVESTIGATION: THE HOIST WAS FOUND TO BE WORKING CORRECTLY, BUT THE SUB-CHASSIS SAFETY CATCH WAS BROKEN AND THE GUIDE BUTTON MISSING. OBSERVATIONS:  THE CO INVESTIGATOR CONCLUDED THAT THE CHAIR OR SUB-CHASSIS HAD CAUGHT ON AN OBSTRUCTION IN THE BATHROOM DURING LOWERING. IT IS POSSIBLE THAT THE SUB-CHASSIS AND THE CASTORS CAME INTO CONTACT WITH THE FLOOR, THE EXCESSIVE LEVERAGE CAUSED THE SAFETY CATCH TO BREAK. THE SUB-CHASSIS THEN MOVED FORWARDS. THE SUDDEN JOLT COULD HAVE ALLOWED THE PATIENT TO SLIDE BETWEEN THE CHAIR ARMS. CONCLUSIONS: USER ERROR AS THE CHAIR OR SUB-CHASSIS WAS NOT LOWERED CLEAR OF OBSTRUCTIONS OR LOCATED PROPERLY. CORRECTIVE ACTIONS: THE SUB-CHASSIS HAS BEEN REPAIRED, HOIST LOAD TESTED AND CLEARED FOR USED.
A PT SLIPPED OFF LIFT CHAIR, NO INJURY OCCURRED.
EXAMINATION: ONE BSQ JIB HAS BEEN RETURNED TO GLOUCESTER FOR EXAMINATION. THE RIGHT HAND SIDE OF THE PICK UP CRADLE HAS BEEN BENT OUTWARDS. OBSERVATIONS: THE JIB CRADLE DAMAGE IS IDENTICAL TO OTHER FIELD FAILURES. CONCLUSION: THE DAMAGE IS CONSIDERED TO BE DUE TO OPERATOR ERROR IN THAT THE PERSONS USING THE HOIST DO NOT APPRECIATE THE FUNCTION OF THE INDEXING MECHANISM. CORRECTIVE ACTION: FOLLOW UP ACTION REQUIRED WITH CUSTOMER.
SCISSOR VALVE ON VENTILATOR REPORTEDLY FOUND STUCK IN CLOSED POSITION ALLEGEDLY CAUSING VENT TO BECOME INOPERABLE. PT REPORTEDLY BECAME DUSKY IN COLOR AND EXPERIENCED A DECREASE IN HEART RATE AND BLOOD PRESSURE. OXYGEN SATURATION REPORTEDLY DECREASED TO 19. MACHINE ALARMS FUNCTIONED APPROPRIATELY. CHEST COMPRESSIONS INITIATED AND PT VENTILATED WITH AMBU BAG. OXYGEN SATURATION AND VITAL SIGNS RECOVERED QUICKLY. VENT RETURNED TO MFR. THE UNIT WAS IN SATISFACTORY CONDITION UPON ARRIVAL. REPAIRS MADE: SECURED FLOATING PULL MAGNET, REPLACED STEP MOTOR, REPLACED BROKEN LAMPS, REPLACED WORN SILICONE MUFF, PERFORMED CALIBRATION AND FINAL FUNCTION CHECK.
DURING SURGERY, END OF INSTRUMENT BROKE OFF AND WENT DOWN INTO SPINAL CANAL. THE DURA WAS NICKED. DR REPAIRED DURAL TEAR AND PROCEEDED WITH SURGERY. SURGERY WAS DELAYED LONGER THAN 30 MINUTES.
THE PT HAD PAIN IN HIS LEFT HIP FOLLOWING A TOTAL HIP REPLACEMENT AT ANOTHER FACILITY 4-5 YRS AGO. HIS ADMITTING SURGICAL DIAGNOSIS WAS: DISASSOCIATED ACETABULUM COMPONENT.
DURING LVAD SUPPORT, THE PT EXPERIENCED SYMPTOMS OF BLEEDING REQUIRING DEVICE EXPLANTATION. THE PT EXPIRED TWO DAYS LATER.
ALL INFO IN SECTIONS A, B, D AND E SUPPLIED BY THE MFR. NO MEDWATCH FORM RECEIVED FROM USER FACILITY OR INTERNATIONAL DISTRIBUTOR.
AN AUS DEVICE WAS IMPLANTED ON 12/8/94. THE BALLOON WAS REVISED ON 10/19/95. A 2ND AUS DEVICE WAS IMPLANTED ON 7/26/96, DUE TO RECURRING INCONTINENCE.
PT CAUGHT HIS TESTICLE IN THE HOLES OF THE SEAT SHELL, AND HAD TO BE CUT OUT.
THIS IS A CLOSE OUT BY THE FOREIGN REPORTER. INVESTIGATION: A PART FROM THE PIECE OF SEAT CUT OUT THE HOIST WAS IN PERFECT WORKING ORDER. OBSERVATIONS: SEAT PLUGS HAD NOT BEEN FITTED. GUIDE LINES FROM THE DEPARTMENT OF HEALTH IN 1986 AND 1992. CONCLUSIONS: THIS INCIDENT WAS THE RESULT OF USER ERROR. GUIDE LINES RECOMMEND THAT A TOWEL OR SIMILAR PROTECTIVE MATERIAL SHOULD BE PLACE BETWEEN THE SEAT AND THE PT. CORRECTIVE ACTIONS: A NEW SEAT SHELL AND SEAT PLUGS HAVE BEEN FITTED.
ACCORDING TO AVAILABLE MEDICAL RECORDS THE VALVE WAS REPLACED ON 10/23/95 FOLLOWING INCREASING SYMPTOMS OF CONGESTIVE HEART FAILURE (CHF) AND PARAVALVULAR LEAK (PV). PT HAD CHF ON CHEST X-RAY AND ACTIVE ENDOCARDITIS. HE HAD MODERATE MITRAL INSUFFICIENCY ACCORDING TO OPERATIVE REPORT. THE PT EXPERIENCED INCREASING SHORTNESS OF BREATH ON 10/27/95 AND WAS PLACED ON A VENTILATOR. HE APPEARED TO ENTER A PHASE OF ARDS. HE CONTINUED ON AGGRESSIVE ANTIBIOTICS AND VENTILATOR SUPPORT FOR SEVERAL WEEKS, AND THEN THE FAMILY ELECTED TO REMOVE THE SUPPORT. HE DIED ON 11/15/95. NO AUTOPSY WAS ELECTED BY THE FAMILY.
F1 SECTION F WAS COMPLETED BY SHILEY INC., THE MFR. NO MEDWATCH REPORT WAS RECEIVED FROM THE USER FACILITY. H3 THE VALVE WAS EXAMINED WITH A LIGHT MICROSCOPE AT 20X MAGNIFICATION. THE OUTLET STRUT LEGS WERE FOUND TO BE INTACT. WEAR PATTERNS TYPICAL FOR VALVES IMPLANTED FOR PERIODS GREATER THAN 14 YEARS WERE OBSERVED ON THE OUTLET STRUT, INLET STRUT, FLANGE INNER DIAMETER, AND DISC. SCRATCHES AND TOOLMARKS WERE NOTED, WHICH COULD HAVE OCCURRED DURING EITHER IMPLANT OR EXPLANT PROCEDURES.
AN INSTRUMENT BROKE DURING SURGERY. AS A CONSEQUENCE, THE SURGEON BELIEVES LESS CORRECTION OF THE SPINE OCCURRED RESULTING IN A DELAY OF THE SURGERY OF ABOUT 30 MINS.
AN ENGINEERING REVIEW OF THE INSTRUMENT CONFIRMED THE INSTRUMENT BREAKAGE. QUALITY CONTROL WAS ADVISED OF THE INCIDENT.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED AND A TANDEM CUFF IMPLANTED DUE TO RECURRING INCONTINENCE.
ADMITTED 7/29/96 THRU ER COMPLAINED OF SOB; DX: RESPIRATORY INSUFFICIENCY PNEUMONIA. ARRESTED ON 8/2/96.  STAFF PROCEEDED TO RESUSCITATE PT USING DEFIBRILLATION PADDLES/EQUIPMENT. IT WAS LATER NOTED THAT THE MONITOR WAS NOT IN THE "PADDLE" MODE WHILE USING PADDLES; IT WAS IN THE LEAD II MODE B/C MODE WHICH CAME UP WHEM MACHINE WAS TURNED ON AND STAFF WAS TRAINED FROM MANUAL THAT MONITORING WITH PADDLES COULD BE DONE WITH LEAD II. WHEN IN FACT, IN ORDER TO IDENTIFY RHYTHM WITHOUT PADDLES-PADDLES MODE MUST BE ON MONITOR SCREEN.
CODE# 1762-LABELED. CODE# 1670-LABELED. SELECTION OF PADDLES MODE IS REQUIRED TO ALLOW FOR LEAD II (ANTERIOR/LATERAL) MONITORING WITH DISPOSABLE DEFIBRILATION/ECG ELECTRODES ELECTRODES IN STERNUM/APEX POSITION. THE DEVICE SETUP HAS BEEN CHANGED TO POWER UP IN PADDLES MODE AND APPROPRIATE USE OF THE DEVICE HAS BEEN REVIEWED.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-BALLOON.
THE CUFF AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO THE CUFF HAVING A TEAR IN IT.
A PT WAS TREATED ON 8/27/96 IN THE RIGHT NASOLABIAL FOLD. PRIOR TO BEGINNING THE INJECTION, THE INJECTOR REMOVED AN AIR POCKET AND EXTRUDED A SMALL AMOUNT OF COLLAGEN THROUGH THE NEEDLE WITHOUT DIFFICULTY. SHE TIGHTENED THE NEEDLE ONTO THE SYRINGE USING A HEMOSTAT. THE INJECTION BEGAN, AND THE INJECTOR HAD DIFFICULTY INJECTING THE COLLAGEN INTO THE DERMIS. THE NEEDLE AND SYRINGE WERE REMOVED FROM THE PT, THE INJECTOR EXTRUDED A SMALL AMOUNT OF MATERIAL WITHOUT PROBLEMS, AND BEGAN INJECTING AGAIN. THERE WAS DIFFICULTY EXTRUDING THE MATERIAL, SO THE INJECTOR APPLIED PRESSURE TO THE PLUNGER. THE HUB OF THE SYRINGE THEN BECAME DISCONNECTED FROM THE NEEDLE; THE NEEDLE WAS LEFT IN THE PT'S SKIN BRIEFLY, AND THE MATERIAL SPLATTERED ONTO THE PT'S FACE, INCLUDING JUST UNDER HER RIGHT EYE, AND ONTO THE EYEGLASSES OF THE INJECTOR. NO HARM OCCURRED TO THE PT OR THE INJECTOR. THE PHYSICIAN BELIEVED IT WAS POSSIBLE THAT THE NEEDLE WAS NOT SECURELY ATTACHED TO THE SYRINGE. THIS EVENT IS BEING REPORTED AS AN MDR BECAUSE IT COULD RESULT IN A SERIOUS INJURY IF IT WERE TO RECUR.
TEN MINUTES INTO BYPASS SURGERY, PERFUSIONIST NOTICED ONLINE PARTIAL PRESSURE FOR OXYGEN (2) DROPPED. INCREASED GAS FLOW WITH NO RESPONSE - 100% OXYGEN DIRECTLY, WITH NO RESPONSE. SWITCHED OUT WITH NEW OXYGENATOR, PRIMED & SUBSTITUTED AT 28 DEGREES. THERE WERE NO PT COMPLICATIONS.
THE OXYGEN TRANSFER OF THE RETURNED UNIT WAS SLIGHTLY LESS (APPROXIMATELY TEN PERCENT LESS) THAN THAT OF THE CONTROL UNIT. CO HAS INFORMED FOREIGN FACTORY OF THIS OCCURRENCE AND THE RETURNED UNIT WAS SENT TO THERE FOR FURTHER EVALUATION. CO WILL SUPPLEMENT THIS REPORT OF ADD'L INFO WARRANTS A SUPPLEMENT.
ON 8/14/96 CO RECEIVED A COPY OF A MEDWATCH REPORT ISSUED BY CO. REPORT NUMBER USF 9608060001-DESCRIBING AN ADVERSE EVENT INVOLVING THE USE OF ANOTHER C PRODUCT IN CONJUNCTION WITH REPORTING CO'S PRODUCT (CODE 4R4215)- THE REPORT ENCLOSED A COPY OF THAT REPORT, DESCRIBING THE EVENT: AN OPERATOR WAS SPRAYED WITH BLOOD IN THE MOUTH WHEN HOLDING THE DEVICE TO THE LAB SITE INTERGAL COMPONENT IN THE CO BLOOD PACK UNIT.
CO REPRESENTATIVE IN THE USA IS ASSISTING IN PREPARING THE ADEQUATE TRAINING MATERIAL FOR THE USE OF, BLOOD SAMPLING DEVICE AND IN ACTUAL TRAINING OF THE SYSTEM USERS AT BLOOD COLLECTION CENTERS.
THE AUS DEVICE WAS IMPLANTED ON 5/11/93. THE CUFF WAS REVISED ON 6/21/94. INFO RECEIVED ON 7/31/96 INDICATES THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 5/9/96, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
A FILTER MIGRATED TO THE PTS ATRIUM 24 HOURS POST PLACEMENT. INFO PROVIDED BY THE USER FACILITY INDICATED THE PT WAS A 75 YR OLD QUADRIPLEGIC. THE FILTER WAS SUCCESSFULLY RETRIEVED WITH A SNARE AND ANOTHER FILTER WAS PLACED WITHOUT PT SEQUELAE. CO IS UNABLE TO OBTAIN INFO REGARDING ROUTINE CHEST PHYSICAL THERAPY, "QUAD COUGHING". THE TYPE OF THERAPY, INDICATED FOR QUADRIPLEGIC FOR MOBILIZATION OF PULMONARY SECRETIONS, MAY BE A COTRIBUTING FACTOR TO FILTER MIGRATION. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED BY THIS MFR. UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE ENGINEERING EVALUATION, A SUPPLEMENTAL MW FORM WILL BE FORWARDED UNDER THE ABOVE NOTED SEQUENCE NUMBER.
H-2. ADDITIONAL INFO RECEIVED AFTER FILING THE MEDWATCH FORM REVEALED THE FILTER DID NOT SPONTANEOUSLY MIGRATE AS ORIGIONALLY REPORTED. SOME TIME POST SUCCESSFUL FILTER PLACEMENT, A CENTRAL LINE WAS ADVANCED. IT IS BELIEVED CENTRAL LINE PLACEMENT CONTRIBUTED TO THIS EVENT.
THE FACTORY TESTED RETENSION SAMPLE DEVICES FROM THE SAME LOT FOR GAS TRANSFER. ALL RESULTS MET SPECIFICATIONS. THE SHIPPING TEST RECORD FOR THIS LOT WAS REVIEWED AND THE TEST RESULTS WERE ALSO WITHIN SPECIFICATION. THE PATIENT'S PUMP RECORD WAS REVIEWED AND THE GAS TRANSFER WAS CONSIDERED TO BE WITHIN NORMAL LEVELS. THE CAUSE OF THIS OCCURRENCE COULD NOT BE DETERMINED.
THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH STRIPS. ON 8/2/96, SHE OPENED A NEW BOX OF TEST STRIPS AND PERFORMED TWO CONTROL TESTS. SHE OBTAINED BACK TO BACK CONTROL SOLUTION RESULTS OF 166 AND 178MG/DL WITH TEST STRIP VERSUS A NORMAL CONTROL SOLUTION RANGE OF 106-158. SHE IMMEDIATELY CALLED TO CO CUSTOMER SUPPORT LINE AND, WHILE ON THE PHONE WITH THE REP, PERFORMED A THIRD CONTROL TEST. THE RESULT WAS 174MG/DL. THE CUSTOMER STATED THAT SHE OPENED THE CONTROL SOLUTION APPROX ONE MONTH AGO. SHE SHOOK THE SOLUTION VIGOROUSLY BEFORE SHE APPLIED THE SAMPLE. ALSO WITH THE REP, THE CUSTOMER OBTAINED A CHECK STRIP RESULT OF 82 VERSUS A CHECK STRIP RANGE OF 76-98. THE DESICCANT IS IN THE OPEN BOTTLE.
CO EVALUATED CUSTOMER'S TEST STRIPS ON 8/19/96. TWO BOTTLES WERE RETURNED TO QA FOR EVALUATION. THE FIRST BOTTLE, CONTAINING 19 TEST STRIPS WAS OPENED BY THE CUSTOMER AND THE DATE THE BOTTLE WAS OPENED WAS UNSPECIFIED. THE SECOND BOTTLE WAS RETURNED UNOPENED AND WAS OPENED BY QA. THE CUSTOMER'S COMPLAINT OF HIGH CONTROL VALUES WAS CONFIRMED USING THE BOTTLE OPENED BY THE CUSTOMER. CONTROL SOLUTION RESULTS FOR THE SECOND CUSTOMER BOTTLE WERE WITHIN SPEC. RETENTION SAMPLES FOR THE LOT WERE COMPARED TO REF METHOD (YSI) AND MET ALL SPECS FOR ACCURACY AND PRECISION. CONTROL VALUES WERE WITHIN RANGE. THIS IS THE FIRST COMPLAINT FOR THIS LOT. THE UNOPENED CUSTOMER BOTTLE AND RETENTION SAMPLES DID NOT CONFIRM THE CUSTOMER COMPLAINT. CO HAS NO EXPLANATION FOR THE FAILURE OF THE PRODUCT IN THE BOTTLE OPENED BY THE CUSTOMER AND CONCLUDES THAT THESE RESULTS ARE AN ANOMALY NOT LIKELY TO RECUR.
AFTER INSERTION AND FLUSHING OF THE DEVICE WITH A PRESERVED SALINE SOLUTION THE PT STATED, "I FEEL FUNNY". THE PT COMPLAINED OF A BURNING SENSATION IN THE MOUTH, FACE WAS FLUSH, AND SHE FELT WOOZY AND LIGHTHEADED. THE PT WAS LAYING SUPINE AND WAS NOT EXPRESSING ANXIETY. THE CATHETER WAS IMMEDIATELY REMOVED AND THE PT SYMPTOMS WERE RESOLVING WHEN THE DR ORDERED HISMANAL 10MG AND ZANTAC 150MG TIMES ONE DOSE. THE PT DID NOT REQUIRE ANY ADD'L RESTICKS AND TREATMENT WAS COMPLETED WITH A PERIPHERAL LINE THAT WAS ALREADY IN PLACE.
DATE SENT TO FDA: 10/11/96. H2 - JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MFR AND SALE OF THE STREAMLINE, LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 9/18/96.
ON 8/8/96 IT WAS DISCOVERED DURING FOLLOW UP ON THE FACILITY COMPLAINT HISTORY OF MACHINE THAT ON 11/30/95 THE MACHINE HAD REMOVED FROM A PT, AN EXCESS OF 1.4 KG OF FLUID. A MEDICAL DEVICE REPORT HAS BEEN OPENED TO PROVIDE DOCUMENTATION OF THE DISCOVERY OF THIS PAST MACHINE PROBLEM, WHICH HAD NOT BEEN REPORTED BY THE FACILITY TO THE MFR AT THE TIME OF THE INCIDENT. SOURCE ATTEMPTED TO RETRIEVE ADD'L INFO, BUT WAS NOT SUCCESSFUL, DUE TO THE LENGTH OF TIME SINCE THE EVENT. PROPER OPERATION OF THIS MACHINE HAS BEEN VERIFIED BY THE MFR ON 8/8/96.
AT THE TIME OF THE INCIDENT, THE MFR WAS NOT NOTIFIED AND THE MACHINE WAS EVALUATED BY THE FACILITY BIO-MED DEPT. THE DESCRIBED EVENT OF EXCESSIVE FLUID LOSS COULD NOT BE DUPLICATED BY THE BIO-MED DEPT. ON 8/8/96 WHILE PERFORMING A FOLLOW UP ON DEVICE STATUS, THE DESCRIBED EVENT WAS DISCOVERED BY THE MFR.
THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION RESULTS AND INACCURATELY LOW BLOOD GLUCOSE READINGS WITH STRIPS. ON 8/1/96 THE CUSTOMER OPENED A NEW BOX OF BLOOD GLUCOSE TEST STRIPS AND OBTAINED CONSECUTIVE BLOOD GLUCOSE READINGS OF 19, 31 AND 35MG/DL. HE FELT THESE READINGS WERE NOT ACCURATE SO HE IMMEDIATELY PERFORMED A NORMAL CONTROL SOLUTION TEST. HE OBTAINED A NORMAL CONTROL SOLUTION RESULT OF 89 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 117-175 MG/DL. BECAUSE OF THESE SEEMINGLY INACCURATE RESULTS, THE CUSTOMER IMMEDIATELY CALLED CO CUSTOMER SUPPORT LINE. WITH THE REP, THE CUSTOMER OBTAINED A NORMAL CONTROL SOLUTION RESULT OF 14 MG/DL. THE CONTROL SOLUTION WAS OPENED TWO MONTHS AGO. THE CUSTOMER SHOOK THE CONTROL SOLUTION VIGOROUSLY BEFORE HE APPLIED THE SAMPLE TO THE TEST PAD. ALSO WITH THE REP, A CHECK STRIP RESULT WAS 84 VERSUS A CHECK STRIP RANGE OF 72-96. THE REP INQUIRED AS TO WHETHER THE DESICCANT IS IN THE BOTTLE. THE CUSTOMER STATED, "NO I JUST TOOK IT OUT WHEN I OPENED THE BOTTLE (APPROX 10 MINS BEFORE CALLING THE CO REP)."
RETENSION SAMPLES FOR LOT 1A614B WERE COMPARED TO REF METHOD (YSI) AND MET ALL SPECS FOR ACCURACY AND PRECISION. CONTROL VALUES WERE WITHIN RANGE. BASED ON EVALUATION OF RETENTION DATA, CO CANNOT CONFIRM CUSTOMER'S COMPLAINT OF LOW READINGS. CO REQUESTED THAT THE PRODUCT BE RETURNED FOR EVALUATION ON 8/1/96. ON 8/15/96, A FOLLOW-UP LETTER WAS RECEIVED FROM THE CUSTOMER STATING THAT THE TEST STRIPS HAD BEEN DISCARDED. NO FURTHER INVESTIGATION IS POSSIBLE. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N.
DEVICE WAS INSERTED AND THREADED EASILY INTO LEFT CEPHALIC VEIN USING A FLOAT IN TECHNIQUE BY WHICH SALINE WAS USED TO FLUSH AT THE SAME TIME THE CATHETER WAS ADVANCED. THE CATHETER WAS IN PLACE 2-3 MINUTES AND THEN WITHIN 30-60 SECONDS AFTER THE HEPARIN FLUSH, THE PT EXPERIENCED HEAD AND NECK FLUSHING, A BITTER TASTE IN THE MOUTH, A "LUMP" IN THE BACK OF THE THROAT, A DROP IN BLOOD PRESSURE AND AN INCREASED PULSE RATE. ABOUT AN HOUR LATER ANGIOEDEMA OF THE THROAT AND UVULA WAS NOTED AS WELL AS ARM SWELLING AT THE DEVICE INSERTION SITE AND THE FOREARM. SYMPTOMS GRADUALLY IMPROVED AFTER THE DEVICE WAS REMOVED AND THE BENADRYL ADMINISTERED. PT DENIED ANY RESPIRATORY DISTRESS OR DIFFICULTY. ANOTHER MFR'S CATHETER WAS PLACED IN THE LEFT WRIST, FLUSHED WITH HEPARIN AND RESULTED IN SWELLING OF THE FOREARM. ANGIOEDEMA DID NOT WORSEN, THE PT IMPROVED AND WAS DISCHARGED 2 DAYS LATER.
DATE SENT TO FDA: 10/11/96. H2-- JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MANUFACTURE AND SALE OF THE STREAMLINE LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 09/18/96. FACILITY'S 3500A FORM, ATTACHED, RECEIVED BY MANUFACTURER ON 09/24/96.
TWO PTS LOST MORE FLUID DURING THE DIALYSIS TREATMENTS THAN THE MACHINE RECORDED. THE FIRST PT COMPLAINED OF FEELING QUEASY AND GENERALLY NOT FEELING WELL. THE PT RECEIVED 200 ML OF NS AND THE TREATMENT WAS CONTINUED. AFTER ABOUT 1 HOUR AND 15 MINUTES THE TREATMENT WAS DISCONTINUED BECAUSE THE PT WAS STILL NOT FEELING WELL. THE PT'S POST WEIGHT INDICATED AN EXCESS OF 2.2 KG OF FLUID WAS REMOVED. THE PT'S SYMPTOMS SUBSIDED AND THE PT LEFT THE CLINIC WITHOUT ANY COMPLAINTS. THE SECOND PT HAS NO SYMPTOMS AND THE UF OUTPUT WAS MONITORED. THE UF AMOUNT COLLECTED WAS 1.4 KG MORE THAN THE MACHINE RECORDED. THIS PT ALSO LEFT THE FACILITY WITHOUT COMPLAINTS. THE MACHINE WAS REMOVED FROM SERVICE BY THE FACILITY TECH. TWO COMPONENTS WERE REPLACED AND PROPER MACHINE OPERATION WAS VERIFIED BEFCORE RETURNING THE MACHINE TO THE TREATMENT AREA. NO PROBLEMS SINCE.
DEVICE WAS REPAIRED BY THE FACILITY TECHNICIAN.
IMMEDIATELY AFTER INSERTION OF DEVICE INTO THE LEFT CEPHALIC VEIN AND FLUSHING WITH SALINE, THE PT COMPLAINED OF TINGLING, ITCHING, NAUSEA AND BURNING ALL OVER. PT BECAME DIAPHORETIC, PULSE WEAKENED THEN BECAME ABSENT. DEVICE WAS REMOVED AND BENADRYL ADMINISTERED. PT LOST CONSCIOUSNESS AND BECAME APNEIC. CODE (RESPIRATORY ARREST) CALLED. PT GIVEN CPR AND AWOKE SPONTANEOUSLY. PT WAS TRANSFERRED TO MICU.
CUSTOMER ORDERED THREE CARDIOPULMONARY VAPORIZER BRACKETS. WHEN RECEIVED, CUSTOMER NOTED THE OUTLET CHECK VALVE WAS ASSEMBLED BACKWARDS. CUSTOMER REASSEMBLED. STOCK OF THE CARDIOPULMONARY VAPORIZER BRACKET WAS INSPECTED, AND THE REPORTED COMPLAINT WAS CONFIRMED. ASSEMBLY INSTRUCTIONS WERE REVIEWED AND FOUND TO BE ADEQUATE. PROPER ASSEMBLY PROCEDURES WERE REVIEWED WITH ASSEMBLY PERSONNEL. IN ADDITION, FURTHER CLARIFICATION WAS ADDED TO THE ASSEMBLY INSTRUCTIONS TO HELP PREVENT A RECURRENCE. FOLLOWING THE CHECKOUT PROCEDURE AS CONTAINED IN THE CARDIOPULMONARY VAPORIZER BRACKET OPERATION AND MAINTENANCE MANUAL SHOULD PICK UP THIS CONDITION, AS WAS THE CASE IN THE REPORTED EVENT. (LABEL)
G1 CORRECTED DATA H2 JOHNSON & JOHNSON MEDICAL, INC. HAD DECIDED TO DISCONTINUE MFR AND SALE OF THE STREAMLINE, LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 9/18/1996.
CUSTOMER REPORTED A LIGHT ANESTHESIA CASE. THERE WAS NO REPORTED PT INJURY. CO'S INVESTIGATION INTO THE REPORTED EVENT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
INVESTIGATION/CONCLUSION: THE UNI WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED, THE CAUSE OF WHICH WA THE ROTARY VALVE. CO HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE TEC 6 VAPORIZER. AS A RESULT, THE FREQUENCY  OF OCCURRENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED U.S. BASE IN FISCAL YEAR 1996 FROM 0.4% IN 1994. CO WILL CONTINUE TO MONITOR THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER MATERIAL AND/OR PROCESS MODIFICATIONS.
THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH TEST STRIPS. ON 8/1/96 IN THE LATE AFTERNOON SHE OPENED A NEW BOX OF TEST STRIPS AND PERFORMED TWO CONTROL TESTS. SHE OBTAINED BACK TO BACK CONTROL SOLUTION RESULTS OF 13 AND 17MG/DL WITH STRIPS VERSUS A NORMAL CONTROL RANGE OF 119-179. THE NEXT MORNING SHE CALLED THE CUSTOMER SUPPORT LINE AND, WHILE ON THE PHONE WITH THE REP, PERFORMED A THIRD CONTROL TEST. THE RESULT WAS 22MG/DL. THE CUSTOMER STATED THAT SHE OPENED THE BOTTLE OF CONTROL SOLUTION ON 8/1/96 AND SHOOK IT VIGOROUSLY BEFORE SHE APPLIED THE SAMPLE. ALSO WITH THE REP, THE CUSTOMER OBTAINED A CHECK STRIP RESULT OF 76 VERSUS A CHECK STRIP RANGE OF 68-92. THE DESICCANT IS IN THE OPEN BOTTLE. CO EVALUATED CUSTOMER'S TEST STRIPS ON 8/19/96. TWO BOTTLES WERE RETURNED TO QA FOR EVALUATION. THE RETURNED BOTTLES WERE OPENED BY THE CUSTOMER AND THE DATE THEY HAD BEEN OPENED WAS UNSPECIFIED. CO CONFIRMED CUSTOMER'S COMPLAINT OF LOW CONTROLS FROM EACH BOTTLE. THE DESICCANT FROM BOTH BOTTLES WAS EVALUATED AND RESULTS CLEARLY INDICATED THAT THE RETURNED WERE NOT CAPABLE OF PROTECTING THE STRIPS AGAINST MOISTURE.
BASED ON THIS INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS CONFIRMED AND TEH EVALUATION OF DESICCANT INSIDE THE RETURNED BOTTLES INDICATES THE FAILURE OF TEST STRIPS MAY BE DUE TO EXPOSURE TO MOISTURE. THE PRODUCT FAILURE IS LIKELY DUE TO EXCESSIVE EXPOSURE TO KOISTURE FROM AN UNKNOWN SOURCE. RETENTION DATA DOES NOT CONFIRM THIS FAILURE SUGGESTING THAT EXPOSURE TO MOISTURE MAY HAVE OCCURRED IN THE FIELD. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? N. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? N. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N.
THE INVESTIGATION WORKSHEET STATED THAT A 10 MML 3.75 MMD IMPLANT WAS PLACED IN THE #18 AREA OF THE MAINTAIN OSSEOINTEGRATION AND WAS REMOVED. THE 10 MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PERIAPICAL RADIOGRAPH WITH NO DATE SHOWED A 10 MML 3.75 MMD IMPLANT IN THE #18 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FAILURE ARE REPORTED IN DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
LIFT JAMMED. PT NOT INJURED BUT MEMBER OF STAFF INJURED HER BACK LIFTING PT OUT OF BATH.
THE FOLLOWING IS A CLOSING OUT REPORT FROM THE FOREIGN REPORTER. EXAMINATION: LIFT CHAIN  HAS BEEN RETURNED FOR EXAMINATION. CHAIN ARTICULATION WAS CHECKED ON THE PRODUCTION TEST RIG. ARTICULATION WAS FOUND TO BE SMOOTH WITH NO STIFF LINKS. CONCLUSIONS: REASON FOR CHAIN JAM REMAINS UNKNOWN. CORRECTIVE ACTION: LIFT HAS BEEN FITTED WITH REPLACEMENT CHAIN.
LEFT TUBING DISCONNECTED FROM LEFT CYLINDER.
THE INVESTIGATIVE WORKSHEET STATED THAT A 15 MML 3.75 MMD IMPLANT WAS PLACED IN THE #19 AREA OF THE MANDIBLE IN 11/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED. THE PANORAMIC RADIOGRAPH WITH NO DATE SHOWED A 15 MML 3.75 MMD IMPLANT IN THE #19 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE POSITION OF THE IMPLANTED DEVICE ERODED THE PT'S SPLEEN NECESSITATING A SPLENECTOMY PROCEDURE.
ALL INFO IN SECTIONS A, B, D AND E IS SUPPLIED BY THE MFR. NO MEDWATCH FORM RECEIVED FROM USER FACILITY OR INTERNATIONAL DISTRIBUTOR.
INVESTIGATION/CONCLUSION: THE UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED, THE CAUSE OF WHICH WAS THE ROTARY VALVE. CO HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE TEC 6 VAPORIZER. AS A RESULT, THE FREQUENCY OF OCCURRENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED IN U.S. BASE IN FISCAL YEAR 1996 FROM 0.4%. CO WILL CONTINUE TO MONITOR THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER MATERIAL AND/OR PROCESS MODIFICATIONS.
HANDPIECE COULD NOT BE CALIBRATED DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
INVESTIGATION/CONCLUSION: THE UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED, THE CAUSE OF WHICH WAS THE ROTARY VALVE. CO HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE TEC 6 VAPORIZER. AS A RESULT, THE FREQUENCY OF OCCURRENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED U.S. BASE IN FISCAL YEAR 1996 FROM 0.4% IN 1994. CO WILL CONTINUE TO MONITOR THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER MATERIAL AND/OR PROCESS MODIFICATIONS.
HANDPIECE EXHIBITED REDUCED POWER DURING A CATARACT EXTRACTION PROCEDURE. THE CASE WAS ABLE TO BE SUCCESSFULLY COMPLETED USING THIS HANDPIECE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F 13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13MML 3.25 MMD IMPLANT WAS PLACED IN THE #13 AREA OF THE MAXILLA TO HELP SUPPORT A 4-UNIT CANTILEVERED BRIDGE. THE BRIDGE FUNCTIONED FOR 5 YRS BEFORE THE IMPLANT BROKE AND HAD TO BE REMOVED. THE 13 MML IMPLANT THAT WAS INCLUDED WITH THIS REORT WAS EXAMINED BY ENGINEERS. IT WS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCE NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PERIAPICAL RADIOGRAPH WITH NO DATE SHOWED THE 13 MML 3.25 MMD IMPLANT IN THE #13 AREA SUPPORTING A 4-UNIT CANTILEVERED BRIDGE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE IMPLANT THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS RECOMMENDED TO REPLACE THE BROKEN IMPLANT WITH A WIDER ONE FOR THE ADD'L SUPPORT.
THE UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED, THE CAUSE OF WHICH WAS THE ROTARY VALVE. CO HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE VAPORIZER. AS A RESULT, THE FREQUENCY OF OCCURRENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED U.S. BASE IN FISCAL YEAR 1996 FROM 0.4% IN 1994. CO WILL CONTINUE TO MONITOR THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER MATERIAL AND/OR PROCESS MODIFICATIONS.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE HAD NO POWER.
SECTIONS A THROUGH F OF THIS MEDWATCH WAS COMPLETED BY THE MFR. THE DATE USED IN SECTION F13 IS THE DATE THE REPORT WAS RECEIVED BY THE MFR.
INVESTIGATION/CONCLUSION: THE UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLIANT WAS CONFIRMED, THE CAUSE OF WHICH WAS THE ROTARY VALVE. CO HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE TEC 6 VAPORIZER. AS A RESULT, THE FREQUENCY OF OCCURRENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED U.S. BASE IN FISCAL YEAR FROM 0.4% IN 1994. CO WILL CONTINUE TO MONITOR THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER MATERIAL AND/OR PROCESS MODIFICATIONS.
INVESTIGATION CONDUCTED. DR CITES SCREW LOOSENING AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES SURGICAL TRAUMA AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES CONE QUALITY/QUANTITY INSUFFICIENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVCERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES BONE QUANTITY INSUFFICIENT AS CAUSE FOR FAILURTE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
PT IN BED WITH RESTRAINT ON. PT FOUND HANGING OVER THE SIDE RAILS OF HER BED WITH THE RESTRAINT WRAPPED AROUND HER NECK UNRESPONSIVE AND PULSELESS.
DEVICE WAS DISCARDED BY THE FACILITY. THIS REPORT IS BASED ON INFO SUPPLIED TO US WITHOUT OUR INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS OR RELATIONSHIP TO THE PRODUCT. WE ARE JUST RESPONDING TO THIS EVENT AS REQUIRED BY LAW. TYPE OF EVENT: DEATH. REPORT DATE: 9/9/96. FREQUENCY & SEVERITY: N,U,N,U.
FOR THE PAST SEVERAL WEEKS, THE FOOTPEDAL USED WITH THIS OPHTHALMIC MICROSURGICAL SYSTEM WOULD STICK. AS A RESULT, THE PROCEDURE TOOK LONGER TO FINISH. THE FOOTPEDAL WAS FINALLY EXCHANGED AND THE DEFECTIVE FOOTPEDAL SENT IN FOR REPAIR.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
INVESTIGATION CONDUCTED. DR CITES POOR PLACEMENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING A CATARACT EXTRACTION PROCEDURE, THIS OPHTHALMIC MICROSURGICAL SYSTEM EXHIBITED LOW ASPIRATION AND THE CASSETTE WOULD NOT CAPTURE CORRECTLY. THE SYSTEM WAS REBOOTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A REQUEST FOR SVC WAS THEN MADE.
CNA WAS PUSHING LIFT OVER DOORWAY THRESHHOLD, IT'S BATTERY DISLODGED FROM HOLDER AND FELL ON HER FOOT.
UPON INSERTION OF PRODUCT IT WAS FOUND TO BE IN EXCELLENT CONDITION. CAUSE OF EVENT WAS USER ERROR, USER DID NOT HAVE BATTERY PROPERLY CLIPPED INTO HOLDER. CUSTOMER HAS BEEN INSTRUCTED TO REFER TO OPERATIONAL MANUAL FOR REVIEW. IS FREQUENCY OF OCCURENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IN USUAL? Y. IS SEVERITY OF OCURRENCE OF THIS EVENT ADRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. ADD;L INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13MMD 3.25MMD IMPLANT WAS PLACED IN THE #13 AREA OF THE MAXILLA TO HELP SUPPORT A BAR OVERDENTURE. THE IMPLANT FUNCTIONED FOR OVER 5 YRS BEFORE THE IMPLANT BROKE AND HAD TO BE REMOVED. THE PERIAPICAL RADIOGRAPH WITH NO DATE, SHOWED A 13 MML 3.25 MMD IMPLANT IN THE #13 AREA OF THE MAXILLA. THE PERIAPICAL RADIOGRAPH WITH NO DATE SHOWED THE 13 MML IMPLANT IN THE #13 AREA WHICH APPEARED TO BE FRACTURED. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE IMPLANT THAN WAS ANTICIPATED. THEREFORE, IT IS RECOMMENDED TO REPLACE THE FAILED IMPLANT WITH A WIDER ONE FOR THE ADD'L SUPPORT.
DURING A CATARACT EXTRACTION PROCEDURE, THIS OPHTHALMIC MICROSURGICAL SYSTEM EXHIBITED POWER SURGES.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F 13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. THE REPORTED PROBLEM COULD NOT BE DUPLICATED. ALL FUNCTIONS OF THE SYSTEM WERE TESTED AND MET REQUIREMENTS.
PT RETURNED TO HOSP AFTER 5 DAYS WITH SWOLLEN ARM AND HAND, WITHOUT CIRCULATION OR SENSATION. (LABEL).
THE DEVICE WAS NOT USED AS SPECIFIED, OR IN ACCORDANCE WITH THE INSTRUCTIONS THAT IS PACKAGED WITH EACH DEVICE. IT IS NOT KNOWN WHAT THE CARE PROVIDER GAVE TO THE PT AS TO INSTRUCTIONS. HOWEVER, PT'S CONDITION INDICATES THAT PT'S ARM DID NOT SUFFER FROST BITE, RATHER LOSS OF CIRCULATION WAS CAUSED BY THE BANDAGE BEING WRAPPED TOO TIGHTLY OR WRAPPED INCORRECTLY.
DURING A DIAGNOSTIC PROCEDURE, THE VALVE OF THIS DEVICE LEAKED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR ANALYSIS.
PADS ARE NOT PEELING APART CORRECTLY. DURING A CALL; CUSTOMER TRIED TO ATTACH PADS, BUT THEY WOULD NOT PEEL APART CORRECTLY. 6/14/96, 70 YR OLD MALE WAS IN CARDIAC ARREST, BACKING PULLED AWAY FROM ELECTRODES, ANOTHER SET OF PADS WAS APPLIED, THIS SET WORKED, PT TRANSPORTED TO HOSP, PT PRONOUNCED AT HOSP.
DURING A DIAGNOSTIC PROCEDURE THE VALVE OF THIS DEVICE LEAKED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR ANALYSIS.
DURING A DIAGNOSTIC PROCEDURE, THE VALVE OF THIS DEVICE LEAKED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE. THE DEVICE IS NOT BEING RETURNED FOR ANALYSIS.
THE INVESTIGATIVE WORKSHEET STATED THAT A 10 MML 3.75 MMD IMPLANT WAS PLACED IN THE #7 AREA OF THE MAXILLA AND 10MML 4.25MMD IMPLANT WAS PLACED IN THE #31 AREA OF THE MANDIBLE. BOTH IMPLANTS FAILED TO MAINTAIN OSSEOINTEGRATION AFTER THEY WERE IN FUNCTION AND HAD TO BE REMOVED. THE 10 MML IMPLANT AND THE OTHER 10 MML IMPLANT THAT WERE INCLUDED WITH THIS REPORT WERE EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WERE FREE FROM ANY DEFECT AND THEY MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC RADIOGRAPH DATED 9/26/95, SHOWED A 10 MML 3.75 MMD IMPLANT IN THE #7 AREA OF THE MAXILLA AND OTHER 10 MML 4.25 MMD IMPLANT IN THE #31 AREA OF THE MANDIBLE, SUPPORTING A 3-UNIT CANTILEVERED BRIDGE. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FOUND THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE PROSTHESIS THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS  RECOMMENDED TO REPLACE THE FAILED IMPLANTS WITH WIDER ONES AND ADD MORE IMPLANTS FOR THE ADD'L SUPPORT.
PT NOTICED SMOKE COMING FROM THE WALL OUTLET IN WHICH THE CONCENTRATOR WAS PLUGGED. PT UNPLUGGED MACHINE BY PULLING ON THE POWER CORD. THERE WAS NO INJURY OR PROPERTY DAMAGE RELATED TO THE EVENT (WITH THE EXCEPTION OF THE ELECTRICAL WALL OUTLET WHICH NEEDED TO BE PLACED).
NELLCOR PURITAN BENNETT HAD AN INDEPENDENT THIRD-PARTY CONSULTING ENGINEER EVALUATE THE POWER CORD UPON ITS RETURN TO THE FACTORY. (THIS CONSULTING ENGINEER SPECIALIZES IN FIRE-RELATED INVESTIGATIONS.) HIS SUMMARY REPORT CONCLUDES THAT THE ROOT CAUSE FOR THE HEAT DAMAGE WAS LIKELY A LOOSE ELECTRICAL RECEPTACLE (HOUSEHOLD OUTLET) INTO WHICH THE CONCENTRATOR WAS PLUGGED. THIS IS EXPECTED TO BE THE FINAL SUBMISSION REGARDING THIS EVENT.
INVESTIGATION CONDUCTED. DR CITES BONE QUANTITY INSUFFICIENT, INFECTION ADN PRE-WXPOSURE OF IMPLANT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING PREP, THE GASKET OF THIS DEVICE DISLODGED. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR ANALYSIS.
INVESTIGATION CONDUCTED. DR CITES BONE QUANTITY INSUFFICIENT AND INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT'S WIFE APPLIED MASK FOR FIRST TIME, NOTED DURING THE FIRST 10-15 MINUTES, PT WAS VERY COMFORTABLE. PT THAN BEGAN HAVING DIFFICULTY BREATHING, COLOR BECAME DARK, AND PT SIGNALED "HE WAS IN DISTRESS". WHEN MASK WAS REMOVED AND REPLACED WITH PT'S REGULAR NASAL MASK, COLOR AND BREATHING RETURNED TO NORMAL. PT SUFFERED NO HARM OR LASTING AFFECT FROM THE REPORTED EVENT.
THIS FOLLOW REPORT CONTAINS REQUESTED INFORMATION FROM FDA.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE, PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PREOP DIAGNOSIS WAS AORTIC REGURGITATION/STENOSIS FOLLOWING HEART CATH PERFORMED ON 4/30/96. AT REOP, "A VERY LARGE PARAVALVULAR LEAK BETWEEN THE NON-CORONARY CUSP AND THE ROOFF OF THE LEFT ATRIUM BY HE LEFT CORONARY ARTERY OSTIA". IN JULY DURING STERNAL REVISION SURGERY, NEW VALVE FUNCTIONED FINE.
ON 14 APRIL, 1993, DR. IMPLANTED A 21MM AORTIC ST. JUDE MEDICAL MECHANICAL HEART VALVE (MODEL 21A-101). ON 30 APRIL, 1996, CARDIAC CATHETERIZATION WAS PERFORMED WHICH REVEALED AORTIC REGURGITATION AND STENOSIS. AT RE-OPERATION, ON 1 MAY, 1996, "A VERY LARGE PARAVALVULAR LEAK BETWEEN THE NON-CORONARY CUSP AND THE ROOF OF THE LEFT ATRIUM BY THE LEFT CORONARY ARTERY OSTIA" WAS OBSERVED. SEVERE PANNUS AND FIBROSIS WAS NOTED AROUND THIS AREA AND THE ENTIRE ANNULUS. THERE WERE NO SIGNS OF THROMBUS OR VEGETATION, AND NO PLEDGETS HAD BEEN UTILIZED. THIS VALVE WAS EXPLANTED ANOTHER DR. THE VALVE WAS REPLACED WITH A 19MM AORTIC ST. JUDE MEDICAL MECHANICAL HEART VALVE HEMODYNAMIC PLUS SERIES (MODEL 19AHP-105). THE PATIENT RECOVERED FROM THIS PROCEDURE IN STABLE CONDITION. IN JULY, 1996, DURING STERNAL REVISION SURGERY, THIS VALVE WAS OBSERVED TO "FUNTION FINE". THE VALVE'S DEVICE HISTORY RECORD WAS EXAMINED TO ENSURE THAT EACH MFG AND INSPECTION OPERATION WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE, INDICATING THAT THE PROCESS WAS PERFORMED IN ACCORDANCE WITH ST. JUDE MEDICAL'S SPECIFICATIONS. EACH OPERATION FOR THE MFG AND INSPECTION OF THIS VALVE WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE. INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH ST. JUDE MEDICAL SPECIFICATIONS AT THE TIME OF MFR. RESULTS OF THIS INVESTIGATION REMAIN INCONCLUSIVE DUE TO THE FACT THAT THE VALVE WAS DESTROYED AND NEVER SENT TO ST. JUDE MEDICAL DIV. FOR TESTING. THE CAUSE OF THE PARAVALVULAR LEAK REMAINS UNK; HOWEVER, IT WAS NOT DUE TO AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY THE VALVE'S DEVICE HISTORY RECORD.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13 MML 4.25 MMD IMPLANT WAS PLACED IN THE #7 AREA OF THE MAXILLA ON 6/5/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 11/23/95. THE 13MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PERIAPICAL RADIOGRAPH DATE 10/12/95, SHOWED A 13 MML 4.25MMD IMPLANT IN THE #7 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILUTE. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
ON THE FIRST POSTOPERATIVE DAY PT EXPERIENCED HYPOTENSIVE EPISODES. TRANSESOPHAGEAL ECHO REVEALED INTERMITTENT SPORADIC LEAFLET CLOSURE, ANATOMICAL INTERFERENCE IS SUSPECTED.
ON MAY 10, 1996, DR. IMPLANTED A 31MM MITRAL MECHANICAL HEART VALVE (MODEL 31M-101, S/N 60267211), UTILIZING PLEDGETED SUTURES. THE PATIENT'S PREOPERATIVE DIAGNOSIS WAS CORONARY ARTERY DISEASE AND MITRAL VALVE REGURGITATION. ON THE FIRST POSTOPERATIVE DAY, THE PATIENT EXPERIENCED HYPOTENSIVE EPISODES. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED INTERMITTENT SPORADIC LEAFLET CLOSURE, AND THE PRESENCE OF TISSUE WAS QUESTIONED. RE-OPERATION WAS PERFORMED IMMEDIATELY. NO MECHANICAL DYSFUNCTION OR TISSUE WAS EVIDENT. THIS VALVE WAS EXPLANTED AND A 29MM MITRAL MECHANICAL HEART VALVE (MODEL 29M-101, S/N 60257182) WAS THEN IMPLANTED. THIS 29MM VALVE WAS PLACED APPROXIMATELY 45 DEGREES CLOCKWISE FROM THE PREVIOUS DIRECT, ANTIANATOMICAL POSITION. THIS SMALLER PROSTHETIC VALVE INITIALLY PERFORMED SIMILARLY ON TEE, ARRHYTHMIA OR ASYMMETRIC VENTRICULAR CLOSURE WERE QUESTIONED. HOWEVER, THE PATIENT THEN BECAME HEMODYNAMICALLY STABLE, AND THE PATIENT RECOVERED FROM THE PROCEDURE IN STABLE CONDITION. THE VALVE WAS RECEIVED IN THE CO ANALYSIS LABORATORY IN A PLASTIC CONTAINER, WIHTIN A PACKAGING BOX, IN A DRY STATE. THE SEWING CUFF WAS REDDISH-BROWN IN COLOR, AND THE CARBON SURFACES WERE COVERED IN A DRIED SUBSTANCE APPEARING TO BE DRIED BLOOD. THE VALVE WAS STEAM STERILIZED, CLEANED, AND THE SEWING CUFF WAS REMOVED. THE VALVE WAS THEN VISUALLY EXAMINED AT 10X MAGNIFICATION FOR ANY ANOMALIES ON THE SURFACES OF THE LEAFLETS AND ORIFICE. BOTH LEAFLETS WERE FOUND TO BE UNREMARKABLE. A SMALL CHIP WAS DETECTED ON THE TOP RIM OF THE SEWING SEAT OF THE ORIFICE, WHICH WAS CAUSED BY A SCALPEL UTILIZED TO REMOVE THE SEWING CUFF DURING THE PRELIMINARY VISUAL EXAMINATION. THE VALVE WAS DISASSEMBLED FOR PERFORMANCE TESTING. THE RESULTS OF THE PULSE DUPLICATOR TESTING INDICATED THE VALVE HAD NO ABNORMAL OPERATION. FLOW AND PRESSURE TRACES INDICATED THE VALVE OPERATED SATISFACTORILY WITHOUT LEAFLET OR HYDRODYNAMIC MALFUNCTIONS. FUNCTIONAL LEAKAGE TESTING WAS PERFORMED, AND THE VALVE MET ALL CO'S SPECIFICATIONS. THE LEAFLET AND ORIFICE DIMENSIONS WERE INSPECTED AND VERIFIED TO BE WITHIN CO'S SPECIFICATIONS. THE VALVE'S DEVICE HISTORY RECORD WAS EXAMINED TO ENSURE THAT EACH MFG AND INSPECTION OPERATION WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE, INDICATING THAT THE PROCESS WAS PERFORMED IN ACCORDANCE WITH CO'S SPECIFICATIONS. EACH OPERATION FOR THE MFG AND INSPECTION OF THIS VALVE WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE. INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESING PERFORMED THROUGH THE ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH SPECIFICATIONS AT THE TIME OF MFR. THE CAUSE OF THE "INTERMITTENT SPORADIC LEAFLET CLOSURE" DETECTED ON THE 31 MM CO MECHANICAL HEART VALVE REMAINS UNK; HOWEVER, IT WAS NOT DUE TO AN INTRINSIC VALVE DYSFUNCTION, AS SUPPORTED BY TESTING PERFORMED UPON THE VLAVE'S RETURN TO CO.
THE INVESTIGATIVE WORKSHEET STATED THAT A 10 MML 3.25 MMD IMPLANT WAS PLACED IN THE ANTERIOR MAXILLA TO HELP SUPPORT A BAROVERDENTURE. THE PROSTHESIS FUNCTIONED FOR OVER 4 YRS BEFORE THE IMPLANT FAILED TO MAINTAIN OSSEOINTEGRATION AND HAD TO BE REMOVED. THE 10 MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY CO ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC RADIOGRAPH DATED 6/26/93 SHOWED THREE 10 MML 3.25 MMD IMPLANTS IN THE #ANTERIOR AREA OF THE MAXILLA. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FOUND THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE PROSTHESIS THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS RECOMMENDED TO REPLACE THE FAILED IMPLANT WITH A WIDER ONE FOR THE ADD'L SUPPORT AND TO CREATE MORE TISSUE SUPPORT WITH YOUR PROSTHESIS.
PT DEVELOPED SHORTNESS OF BREATH, PANSYSTOLIC MURMUR, AND EARLY DIASTOLIC MURMUR CONSISTENT WITH MODERATE AORTIC INCOMPETENCE. VALVE WAS EXPLANTED. PT NONCOMPLIANCE WITH ANTICOAGULANT REGIME IS SUSPECTED.
INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH CO SPECIFICATIONS AT THE TIME OF MFR. CO PHYSICIAN'S MANUAL RECOMMENDS THAT PATIENT'S IMPLANTED WITH A CO MECHANICAL HEART VALVE BE ROUTINELY MAINTAINED WITH ANTICOAGULATION. RESULTS OF THIS INVESTIGATION INDICATED THE THROMBUS OBSERVED INTRAOPERATIVELY WAS MOST LIKELY DUE TO NONCOMPLIANCE WITH THE ANTICOAGULATION REGIME. TESTING PERFORMED AT CO DIV. INDICATED NO VALVE DYSFUNCTION. PAGES = 2.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS - MODEL/CATALOG # 3412TPS/3412TPS, 3414HL/3414HL, 3412TPS/3412TPS, 3414HL/3414HL, 3410TPS/3410TPS, 2912HL/2912HL, 2912HL/2912HL. LOT NUMBER 951825, 9536291, 951825, 9636291, 951505, 965600, 965600.
THE TUBING WITH THE DRIP CHAMBER VENT SLIDE CLAMP IS REVERSED WITH THE TUBING WITH THE BACKCHECK VALVE WITH UPPER Y-INJECTION SITE WHERE THEY ENTER THE DRIP CHAMBER. THE RESULT IS THE IV FLUID RUNS DOWN THE SIDE OF THE DRIP CHAMBER INSTEAD OF DRIPPING INTO THE DRIP CHAMBER.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS - MODEL/CTALOG # 4512JHL/4512HL. LOT NUMBER UNK.
TRIPLE LUMEN CENTRAL CATHETER'S GUIDE WIRE IS UNWINDING. IT IS VERY DIFFULT TO REMOVE FROM R SUBCLAVIAN VEIN. RPTR HAS USED THIS CATHETER MULTIPLE TIMES WITHOUT THIS DIFFICULTY.
SINCE IMPLANTATION OF THESE EXTRA-OCULAR CIRCLING BANDS BEGINNING IN APRIL 1996, FIVE PTS HAVE SUFFERED TREMENDOUS INFLAMMATORY REACTION, RESTRICTED MOBILITY AND EXOPHTHALMOS. THE CIRCLING BANDS WERE EXPLANTED AND THE PTS REIMPLANTED WITH ANOTHER CIRCLING BAND. ON THE SIXTH DAY THERE WAS THE DISAPPEARANCE OF PAIN AND INFLAMMATION. THE CIRCLING BAND WAS EXAMINED IN THE BACTERIOLOGICAL DEPARTMENT. NO INFECTIONS WERE FOUND. THE CIRCLING BANDS BEING USED ARE OF TWO DIFFERENT COLORS: ONE IS BLUE AND THE OTHER HAS A "YELLOW" SHINE. THE BANDS WITH THE BLUE SHINE WERE INVOLVED IN THE REPORTED INCIDENTS.
SUMMARIZATION OF CYTOTOXICITY TESTS ARE AS FOLLOWS: SAMPLE E5381-700 LOT 261038345 IDENTIFIED AS "BLUE" AND "PROBLEM": GRADE/REACTIVITY: 0/NONE, CONCLUSION: NOT CYTOTOXIC. SAMPLE E5381-700 LOT 149035276 IDENTIFIED AS "YELLOW" AND "NO PROBLEM": GRADE/REACTIVITY: 1/SLIGHT, CONCLUSION: NOT CYTOTOXIC. SAMPLE E5381-700 PART REPRESENTING CURRENT INVENTORY: GRADE/REACTIVITY: 0/NONE, CONCLUSION: NOT CYTOTOXIC.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY INSUFFICIENT AS CAUSE FOR FAILURE. PT IS A SMOKER. THIS FILE IS CLOSES. THE REPROTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE TUBING WITH THE DRIP CHAMBER VENT SLIDE CLAMP IS REVERSED WITH THE TUBING WITH THE BACKCHECK VALVE WITH UPPER Y-INJECTION SITE WHERE THEY ENTER THE DRIP CHAMBER. THE RESULT IS THE IV FLUID RUNS DOWN THE SIDE OF THE DRIP CHAMBER INSTEAD OF DRIPPING INTO THE DRIP CHAMBER. IV SET WAS USED TO ADMINISTER DIPYRIDAMOLE FOR A STRESS TEST; THE NURSE HAD TO MANUALLY SQUEEZE THE DRIP CHAMBER TO ADMINISTER THE DRUG TO THE PT DURING THE STRESS TEST.
INVESTIGATION CONDUCTED. DR CITES POOR ORAL HYGIENE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13 MML 3.75 MMD IMPLANT WAS PLACED IN THE #29 AREA OF THE MANDIBLE ON 10/5/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 11/28/95. THE 13 MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCE NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC RADIOGRAPH WITH NO DATE SHOWED A 13 MML 3.75 MMD IMPLANT IN THE #29 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE CONDITION REPORTED IS ASSUMED VALID BASED ON THE SAMPLES RETURNED. THE ACTUAL SUBSTANCE OBSERVED INSIDE THE BARRELS WAS SILICONE LUBRICANT. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR THE PROPER FUNCTION OF DISPOSABLE HYPODERMIC PRODUCTS. THIS CONDITION OCCURS WHEN SILICONE LUBRICANT, USED ON THE INTERIOR OF THE SYRINGE BARREL TO FACILITATE PLUNGER MOVEMENT, IS INADVERTENTLY OVERSPRAYED ON THE SYRINGE FOLLOWING MACHINE START-UPS. THESE SYRINGES SHOULD HAVE BEEN REMOVED FROM PRODUCTION. BECTON DICKINSON TAKES EVERY ASPECT OF A NEEDLE STICK VERY SERIOUSLY, AND DOES EVERYTHING TO INVESTIGATE THE ROOT CAUSES INVOLVED WITH A MFG DEFECT SUCH AS THIS. AS A CORRECTIVE ACTION CO HAS INSTITUTED IMPROVED CONTROLS OVER THE SILICONE APPLICATION SYSTEMS USED ON THESE PRODUCTS, AND CO EXPECTS THESE CONTROLS WILL SIGNIFICANTLY REDUCE THIS UNACCEPTABLE CONDITION.
WHEN PRIMING THE TUBING, THE TUBING SEPARATED JUST ABOVE THE DRIP CHAMBER.
PT DEVELOPED RESPIRATORY DISTRESS. RESPIRATORY DISTRESS DOCUMENTED BY ABG. PHYSICIAN REQUESTED VENTILATOR TO BE CHANGED AND REQUESTED A PERFORMANCE VERIFICATION TO BE PERFORMED ON THE VENTILATOR. PT APPEARED TO STABILIZE ON NEW VENTILATOR AFTER READJUSTING VENTILATOR PARAMETERS AND DRUG INTERVENTION. PT DID NOT SUFFER ANY PERMANENT IMPAIRMENT. DATE: 5/21/96 @ 10:54 AM. ABG RESULTS: PH-7.034 BE-5.5, PACO2-176.3 O2SAT-89.8%.
SINCE IMPLANTATION OF THESE EXTRA-OCULAR CIRCLING BANDS BEGINNING IN 4/96, FIVE PTS HAVE SUFFERED TREMENDOUS INFLAMMATORY REACTION, RESTRICTED MOBILITY AND EXOPHTHALMOS. THE CIRCLING BANDS WERE EXPLANTED AND THE PTS REIMPLANTED WITH ANOTHER CIRCLING BAND. ON THE SIXTH DAY THERE WAS THE DISAPPERANCE OF PAIN AND INFLAMMATION. THE CIRCLING BAND WAS EXAMINED IN THE BACTERIOLOGICAL DEPARTMENT. NO INFECTIONS WERE FOUND. THE CIRCLING BANDS BEING USED ARE OF TWO DIFFERENT COLORS: ON IS BLUE AND THE OTHER HAS A "YELLOW" SHINE. THE BANDS WITH THE BLUE SHINE WERE INVOLVED IN THE REPORTED INCIDENTS.
THE ACTUAL CONDITION, A JAMMED OR DISTORTED STOPPER, RESULTS FROM MISALIGNMENT DURING ASSEMBLY WHICH CAUSES THE STOPPER TO STRETCH AND DISTORT AS IT IS PUSHED INTO THE SYRINGE'S BARREL. CO HAS FORWARDED THIS REPORT AND THE SAMPLE RETURNED TO CO'S MFG FACILITY FOR THEIR REVIEW AND INVESTIGATION.
SINCE IMPLANTATION OF THESE EXTRA-OCULAR BANDS BEGINNING IN 4/96, FIVE PTS HAVE SUFFERED TREMENDOUS INFLAMMATORY REACTION, RESTRICTED MOBILITY AND EXOPHTHALMOS. THE CIRCLING BANDS WERE EXPLANTED AND THE PTS REIMPLANTED WITH ANOTHER CIRCLING BAND. ON THE SIXTH DAY THERE WAS THE DISAPPEARANCE OF PAIN AND INFLAMMATION. THE CIRCLING BAND WAS EXAMINED IN THE BACTERIOLOGICAL DEPARTMENT. NO INFECTIONS WERE FOUND: THE CIRCLING BANDS BEING USED ARE OF TWO DIFFERENT COLORS: ONE IS BLUE AND THE OTHER HAS A "YELLOW" SHINE. THE BANDS WITH THE BLUE SHINE WERE INVOLVED IN THE REPORTED INCDIENTS.
SECTIONS A THROUGH F OF THIS MEDWATCH WERE COMPLETED BY THE MFR. TEH DATE USED IN SECTION F.13 IS THE DATE THE REPORT WAS RECEIVED BY THE MFR. VISAUAL EXAMINATION OF THE SAMPLE PRODUCT INDICATED THAT IT HAD BEEN TRIMMED TO DIFFERENT LENGTH AND END CONFIGURATION AND RESTERILIZED BY ETO IN A HOSP PEEL POUCH WITH AN ETO INDICATOR. THE "YELLOW" IMPLANT WAS ARECEIVED IN A SEALED PEEL POUCH. TEH QUALITY CONTROL INSPECTOR HAS OBNSERVED VERY SUBTLE "YELLOW" AND "BLUE" TINGED PARTS IN THE PAST WHICH SEEM TO BE RELATED TO THE AGE AND THICKNESS OF THE IMPLANTS. THE THICKER IMPLANTS APPEAR SLIGHTLY MORE "BLUR" AND THE OLDER IMPLANTS LOOK SLIGHTLY MORE "YELLOW." TOXICITY TESTING ON BOTH SAMPLES OF RETURNED PRODUCT WILL BR PERFORMED AND RESULTS WILL BE FORWARDED AS ADD'L INFO.
THE INVGESTIGATIVE WORKSHEET STATED THAT A 10 MML 3.75 MMD IMPLANT WAS PLACED IN THE #23 AREA OF THE MANDIBLE ON 8/29/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 12/14/95. THE 10MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PERIAPICAL RADIOGRAPH DATED 1/10/95 SHOWED A 10 MML 3.75 MMD IMPLANT IN THE #23 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE INVESTIGATIVE WORKSHEET STATED THAT A 16 MML 3.7 MMD IMPLANT WAS PLACED IN THE #27 AREA OF THE MANDIBLE ON 1/17/96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 2/20/96. THE 16 MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINNERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC RADIOGRAPH DATE 5/30/95 SHOWED A 16 MML 3.7 MMD IMPLANT IN THE #27 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
DEVICE WAS BEING UTILIZED ON A MALE PT PRESENTED WITH A SUBARACHNOID HEMORRHAGE. DURING THE PROCEDURE THE DISTAL TIP SEPARATED INTO THE ORIGIN OF THE LEFT VERTEBRAL ARTERY. THE PHYSICIAN WAS EVENTUALLY ABLE TO MOBILIZE THE SEPARATED SEGMENT.
THE CATHETER WAS RETURNED IN AN OPEN AND USED CONDITION. AN EVAL CONFIRMED THAT THE DEVICE HAS SEPARATED AT THE DISTAL TIP. THE SEPARATION SEGMENT WAS NOT RETURNED. CO CAN ADVISE THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT AND ARE CURRENTLY INVESTIGATING THIS MATTER TO ASSURE IT DOES NOT RECUR.
SINCE IMPLANTATION OF THESE EXTRA-CIRCLING BANDS BEGINNING  IN 4/96, FIVE PTS HAVE SUFFERED TREMENDOUS INFLAMMATORY REACTION, RESTRICTED MOBILITY AND EXOPHTHALMOS. THE CIRWCLING BANDS WERE EXPLANTED AND THE PTS REIMPLANTED WITH ANOTHER CIRCLING BAND. ON TEH SIXTH DAY THERE WAS THE DISAPPEARANCE OF PAIN AND INFLAMMATION. THE CIRCLING BAND WAS EXAMINED IN THE BACTERIOLOGICAL DEPARTMENT. NO INFECTIONS WERE FOUND. THE CIRCLING BANDS BEING USED ARE TWO DIFFERENT COLORS: ONE IS BLUE AND THE OTHER HAS A "YELLOW" SHINE. THE BANDS WITH THE BLUE SHINE WERE INVOLVED IN THE REPORTED INCIDENTS.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13 MML 3.7 MMD IMPLANT WAS PLACED IN THE #23 AREA OF THE MANDIBLE ON 10/16/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMVOED ON 12/20/95. THE 13MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC RADIOGRAPH DATE 11/16/95, SHOWED A 13 MML 3.7 MMD IMPLANT IN THE #23 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
SINCE IMPLANTATION OF THESE EXTRA-OCULAR CIRCLING BANDS BEGINNING IN 4/96, FIVE PTS HAVE SUFFERED TREMENDOUS INFLAMMATORY REACTION, RESTRICTED MOBILITY ANE EXOPHTHALMOS. THE CIRCLING BANDS WERE EXPLANTED AND THE PTS REIMPLANTED WITH ANOTHER CIRCLING BAND. ON THE SIXTH DAY THERE WAS THE DISAPPEARANCE OF PAIN AND INFLAMMATION. THE CIRCLING BAND WAS EXAMINED IN THE BACTERIOLOGICAL DEPARTMENT. NO INFECTIONS WERE FOUND. THE CIRCLING BANDS BEING USED ARE OF TWO DIFFERENT COLORS: ONE IS BLUE AND THE OTHER HAS A "YELLOW" SHINE. THE BANDS WITH THE BLUE SHINE WERE INVOLVED IN THE REPORTED INCIDENTS.
SUMMARIZATION OF CYTOTOXICITY TESTS ARE AS FOLLOWS: LOT IDENTIFIED AS "BLUE" AND "PROBLEM": GRADE/REACTIVITY: NONE, CONCLUSION: NOT CYROTOXIC. SAMPLE LOT IDENTIFIED AS "YELLOW" AND "NO PROBLEM": GRADE/REACTIVITY:L/SLIGHT, CONCLUSION: NOT CYTOTOXIC. SAMPLE PART REPRESENTING CURRENT INVENTORY: GRADE/REACTIVITY: NONE, CONCLUSION: NOT CYTOTOXIC.
THE DEVICE WAS REMOVED DUE TO "INFECTION" AND "REJECTION". AS REPORTED TO CO, "SCROTAL DRAINAGE" WAS OBSERVED AT THE TIME OF SURGERY. THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED; LEAVING THE CYLINDER(S) IN PLACE AT THIS TIME.
THE DEVICE WAS REMOVED DUE TO "INFECTION" AND "REJECTION". "SCROTAL DRAINAGE" WAS OBSERVED AT THE TIME OF SURGERY. THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED; LEAVING THE CYLINDER(S) INPLACE AT THIS TIME. 9/18/96-IT WAS REPORTED THAT ON 9/17/96, THE CYLINDER(S) WHICH WERE LEFT INPLACE ON 8/8/96; WERE REMOVED DUE TO A "WOUND DEHISSCENCE", SECONDARY TO "INFECTION".
ADDITIONAL INFORMATION WAS RECEIVED ON 8/18/96 INDICATING THAT THE REMAINDER OF THIS DEVICE, THE CYLINDERS, WERE REMOVED DUE TO "WOUND DEHISCENCE" AND "INFECTION" ON 9/17/96. ADDITIONALLY IT WAS INDICATED THAT THERE WAS "NOTHING WRONG WITH THE DEVICE." IN THE RECEIVED INFORMATION THE PHYSICIAN STATED THAT THE INFECTION WAS LOCATED AROUND THE PUMP AND THAT A "WOUND SEPARATION" CONTRIBUTED TO THIS OCCURRENCE. CULTURES TAKEN SHOWED THE PRESENCE OF STAPH ORGANISMS, BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE INFECTION REPORT. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION IN 1980. PLAINTIFF ALLEGES" DAMAGES" AND REFERS TO MASTER COMPLAINT FIELD IN RE: COORDINATED BREAST IMPLANT LIGITATION.
NO PRODUCT IDENTIFICATION IS GIVEN. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
THE INVESTIGATION WORKSHEET STATED THAT A 10 MML 3.75 MMD IMPLANT WAS PLACED IN THE #7 AREA OF THE MAXILLA AND ANOTHER BRAND 10 MML 4.25 MMD IMPLANT WAS PLACED IN THE #31 AREA OF THE MANDIBLE. BOTH IMPLANTS FAILED TO MAINTAIN OSSEOINTEGRATION AFTER THEY WERE IN FUNCTION AND HAD TO BE REMOVED. THE 10 MML IMPLANT AND THE 10 MML (ANOTHER MODEL) IMPLANT THAT WERE INCLUDED WITH THIS REPORT WERE EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANTS WERE FREE FROM ANY DEFECT AND THEY MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC  RADIOGRAPH DATED 9/26/95 SHOWED A 10 MML 3.75 MMD IMPLANT IN THE #31 AREA OF THE MANDIBLE, SUPPORTING A THREE-UNIT CANTILEVERED BRIDGE. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FOUND THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE PROSTHESIS THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS RECOMMENDED TO REPLACE THE FAILED IMPLANTS WITH WIDER ONES AND ADD MORE IMPLANTS FOR THE ADD'L SUPPORT.S
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 11/19/84 WITH EXPLANT 5/6/93. PLAINTIFF ALLEGES" DAMAGES" AND REFERS TO MASTER COMPLAINT FILED IN IN RE; COORDINATED BREAST IMPLANT LITIGATION, JCCP 2754.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 10/1/79. PLAINTIFF ALLEGES "DAMAGES" AND REFERS TO MASTER COMPLAINT FILED IN IN RE: COORDINATED BREAST IMPLANT LITIGATION, JCCP 2754.
THE DEVICE WAS REMOVED DUE TO "INFECTION". THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED.
THE PHYSICIAN STATED THAT THE PT PRESENTED WITH "DISCOMFORT ASSOCIATED WITH MANIPULATION OF THE RIGHT-SIDED INTRASCROTAL BULB OR THE SUPRAPUBIC AREA WHICH BECAME SWOLLEN." THE PHYSICIAN FURTHER STATED THAT ANTIBIOTICS DID NOT IMPROVE THE PT'S DISCOMFORT AND THE DECISION TO EXPLORE AND POSSIBLY EXCISE THE PROSTHESIS WAS MADE. THE PHYSICIAN NOTED THAT DURING SURGERY "A POCKET OF BROWNISH RED PURULENCE" WAS FOUND SURROUNDING THE DEVICE AND THAT CULTURES WERE TAKEN AT THAT TIME. THESE CULTURES DID NOT SHOW ANY GROWTH. THE PHYSICIAN STATED THAT THE PT'S VASCULAR DISEASE MAY HAVE CONTRIBUTED TO THIS EVENT. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE INFECTION REPORT. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13 MML 4.7 MMD IMPLANT WAS PLACED IN THE #30 AREA OF THE MANDIBLE ON 6/9/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 2/28/96. THE 13 MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC RADIOGRAPH DATE 6/9/96 SHOWED A 13 MML 4.7 MMD IMPLANT IN THE #30 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOUL DHAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
CONSUMER ENGAGED IN SEXUAL INTERCOURSE WITH A FEMALE PARTNER THAT WAS KNOWN TO HAVE HERPES. CONSUMER WAS WEARING A CONDOM WHICH BROKE DURING INTERCOURSE. HE APPLIED A SECOND CONDOM WHICH ALSO BROKE. UPON DEVELOPING LESIONS IN HIS GENITAL AREA ALONG WITH OTHER HERPES TYPE SYMPTOMS, THE CONSUMER VISITED A UROLOGIST. THE DR PERFORMED A SERUM TEST TO DETECT THE IGM (HERPES) VIRUS. THE RESULTS OF THIS TEST WAS NEGATIVE FOR THE VIRUS. THE TEST WAS REPEATED APPROX 3 WEEKS LATER. THIS TIME RETURNING A POSITIVE RESULT. CONSUMER WAS PLACED ON ZOVIRAX AND WAS COUNSELED REGARDING HIS CONDITION. HE WAS LATER TREATED BY A DIFFERENT DR FOR DEPRESSION AND STRESS WHICH RESULTED FROM HIS CONDITION. THE CONSUMER WAS PLACED ON AN ANTIDEPRESSANT AND A TRANQUILIZER TO TREAT HIS EMOTIONAL CONDITION.
ENCLOSED IS CO'S FILING WHICH CONTAINS INFO PROVIDED BY THIRD PARTIES WHICH HAS NOT BEEN INDEPENDENTLY VERIFIED BY CO. THE SUBMISSION IS FILED IN THE FORMAT FOR MEDICAL DEVICE REPORTS, 21 C.F.R PART 803, FOR EASE OF REFERENCE ONLY. THE FILLING OF THE REPORT IS NOT AN ADMISSION OF LIABILTY OR AN ADMISSION THAT THE REPORT IS REQUIRED UNDER PART 803.
THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A 2-PIECE INFLATABLE.
IN THE RECEIVED INFO THE PHYSICIAN STATED THAT THE DEVICE CONTAINED "NO FLUID". THE PHYSICIAN FURTHER STATED THAT THERE WERE NO APPARENT CIRCUMSTANCES OR INFO IN THE PT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE. THE PHYSICIAN ALSO STATED THAT THE DEVICE WAS NOT DAMAGED DURING THE EXPLANT PROCEDURE. EXAMINATION AND TESTING OF THE DEVICE REVEALED A LEAKAGE SITE AT THE PROXIMAL CONNECTOR ATTACHED TO OUTLET #2. THE LEAKAGE WAS OBSERVED FROM BENEATH THE CONNECTOR. THE LOCATION OF THE SITE SUGGESTS THERE IS A TEAR IN THE TUBING AT THE CONNECTOR CLAMP/TUBE CONTACT POINT. BASED ON QA'S EXAMINATION AND THE PHYSICIAN'S OBSERVATIONS, QA CONCLUDEWD THAT THE SECURE CLAMP MOST LIKELY FATIGUED THAT UNDERLYING TUBING AND THAT DEVICE USAGE OVER TIME IN COMBINATION WITH THIS FATIGUE,CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBING ALLOWING THE LOSS OF FLUID FROM THIS SITE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
CONSUMER STATES THAT SHE IS 3 WEEKS PREGNANT DUE TO ALLEGED CONDOM FAILURE. SHE STATES THAT THERE WERE NO BROKEN CONDOMS, BUT ONE MUST HAVE LEAKED AS SHE USED A CONDOM EACH TIME SHE ENGAGED IN SEXUAL ACTIVITY.
ENCLOSED IS CO'S FILING WHICH CONTAINS INFO PROVIDED BY THIRD PARTIES WHICH HAS NOT BEEN INDEPENDENTLY VERIFIED BY CO. THE SUBMISSION IS FILED IN THE FORMAT FOR MEDICAL DEVICE REPORTS, 21 C.F.R, PART 803, FOR EASE OF REFERENCE ONLY. THE FILING OF THE REPORT IS NOT AN ADMISSION OF LIABILITY OR AN ADMISSION THAT THE REPORT IS REQUIRED UNDER PART 803.
THE INVESTIGATIVE WORK SHEET STATED THAT A 13 MML 3.25 MMD IMPLANT WAS PLACED IN THE #13 AREA OF THE MAXILLA TO HELP SUPPORT A FULL UPPER DENTURE. THE IMPLANT WAS IN FUNCTION FOR ALMOST FIVE YRS BEFORE IT BROKE AND HAD TO BE REMOVED. THE 13MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS.
DEVICE WAS INTRODUCED AND AN INJECTION PERFORMED. UPON ATTEMPTED REMOVAL, THE CATHETER TIP SEPARATED. A RETRIEVAL DEVICE WAS UTILIZED FOR REMOVAL OF THE SEPARATED SEGMENT. PT HAS NOT SUSTAINED ANY ADVERSE EFFECT FROM THIS EVENT.
THE DEVICE WAS RETURNED IN AN OPENED AND USED CONDITION. THE PRODUCT WAS RETURNED IN TWO PIECES. THE FIRST WAS THE MAIN BODY OF THE CATHETER, APPROX. 83.5CM IN LENGTH WITH A PW FITTING ON THE PROXIMAL END AND .3 TO .5CM OF TIP MATERIAL ON THE DISTAL END. THE SECOND PIECE WAS 3CM IN LENGTH OF THE DISTAL END TIP MATERIAL. THE TIP IS NOW IN THREE PIECES; 1.7CM, 1.0CM AND .3CM, ALL BROKEN DURING EVALUATION. THE BREAK BETWEEN THE DISTAL TIP AND THE CATHETER TOOK PLACE AT A 12 DEGREE ANGLE. AT THIS TIME CO IS  UNABLE TO DETERMINE WHAT CAUSED THE TIP BREAKAGE.
PT WITH DIARRHEA UNDERWENT FLEXIBLE SIGMOIDOSCOPY. INSTRUMENT WAS PASSED TO 60CM. BIOPSIES OBTAINED FROM NORMAL APPEARING SIGMOID COLON WITH MULTIPLE SAMPLE FORCEPS. TWO HOURS LATER, PT COMPLAINED OF ABDOMINAL PAIN, FEVER. NOTED TO HAVE EVIDENCE OF PERITONITIS AND WBL OF 13,000. LAPAROTOMY CONFIRMED SMALL PERFORATION IN SIGMOID COLON WHICH WAS CLOSED PRIMARILY. PT DISCHARGED FROM HOSP AFTER 7 DAYS.
THE GI TISSUE WAS NORMAL AND THE PERFORATION WAS NOTED AFTER THE SURGERY WAS PERFORMED. DR. BELIEVES THE UNIT WAS A SAMPLE SEAT TO THEM AND THE POUCH WAS DISCARDED.
DEVICE WAS BEING UTILIZED FOR A DISSECTION OF THE RCA. THE STENT/BALLOON CATHETER WAS PLACED. THE BALLOON WAS INFLATED TO DEPLOY THE STENT. THE STENT WAS DEPLOYED IN THE MID RCA. THE BALLOON CATHETER WAS REMOVED AND THE GUIDE CATHETER WAS PULLED BACK. AN INJECTION WAS MADE AND AT THAT TIME A DISSECTION WAS NOTED DISTAL TO THE STENT. IT WAS THOUGHT THE DISSECTION OCCURRED DUE TO THE STENT DEPLOYMENT BALLOON.
H6-86-REVIEW OF MFG RECORDS AND DISCUSSION WITH CLINICAL NURSE SPECIALIST.
THE INVESTIGATIVE WORKSHEET STATED THAT A 10 MML 3.75 MMD IMPLANT WAS IMPLANT WAS PLACED IN THE #19 AREA AND A 13MML 3.75 MMD IMPLANT WAS PLACED IN THE #30 AREA OF THE MANDIBLE ON 2/8/96. THE IMPLANTS FAILED TO OSSEOINTEGRATE AND WERE REMOVED ON 4/3/96. THE 2 IMPLANTS WERE INCLUDED WITH THIS REPORT WERE EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANTS WERE FREE FROM ANY DEFECT AND THAT THEY MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC RADIOGRAPH WITH NO DATE SHOWED THE 10 MML 3.75 MMD IMPLANT IN THE #19 AREA, AND THE 13 MML 3.75 MMD IMPLANT IN THE #30 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANTS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
DURING INSERTION OF A DOUBLE LUMEN CENTRAL VENOUS CATHETER THE J-WIRE KNOTTED. ATTEMPTS TO REMOVE THE J-WIRE FROM THE SUBCLAVICULAR REGION WERE UNSUCCESSFUL. THE J-WIRE BROKE AND THE DISTAL PORTION WAS NOTED IN THE SUBCLAVICULAR REGION BY X-RAY. A RIGHT CLAVICULAR CUT DOWN WAS PERFORMED TO RETRIEVE THE J-WIRE.
THE PRODUCT WAS RETURNED IN AN OPENED AND USED CONDITION. INVESTIGATION REVEALED THE CUSTOMER HAD RETURNED 4.2CM OF THE DISTAL TIP. THE TIP HAD BEEN MANIPULATED INTO A KNOT APPROX.1.9CM FROM THE DISTAL END. CO CAN INFORM THE CUSTOMER THAT THIS WIRE GUIDE IS VISUALLY INSPECTED 100%. AT THIS TIME, CO IS UNSURE AS TO HOW THE J WIRE TIP KNOTTED. IT IS POSSIBLE THAT, DUE TO REPEATED INWARD AND OUTWARD MOVEMENT OF THE WIRE GUIDE, A KNOT MAY HAVE FORMED. IF THE WIRE GUIDE WAS ADVANCING THROUGH A TORTUOUS PATH, THEN THE POSSIBILITY INCREASES. IN ADDITION, THIS WIRE GUIDE HAS A VERY FLEXIBLE TIP.
PT WAS IN CARDIAC CATH LAB FOR STENT PLACEMENT IN A CORONARY ARTERY. DR COULD NOT ADVANCE THE CATHETER INTO THE AREA NEEDED. BALLOON AND STENT WITHDRAWN. STENT BECAME DISLODGED FROM THE BALLOON AND WAS FOUND IN THE INTRODUCER SHEATH IN THE PT'S RIGHT FEMORAL ARTERY. PT WAS TRANSPORTED TO A ROOM TO WAIT FOR HIS BLOOD TO THICKEN IN ORDER TO REMOVE THE INTRODUCER SHEATH AND STENT. UPON REMOVING THE SHEATH, THEEH STENT WAS NOT PRESENT. PT WAS THEN TAKEN TO RADIOLOGY WHERE THE STENT WAS FOUND IN THE RIGHT POPLITEAL ARTERY AND REMOVED.
AN EXAM OF THE RETURNED DEVICE FOUND ONLY UNRAVELLED STENT TO HAVE BEEN RETURNED FOR EVALUATION. FROM THE INFO PROVIDED, IT APPEARS DIFFICULTY WAS ENCOUNTERED REACHING THE DESIRED LOCATION WITH THE STENT/BALLOON CATHETER. THE STENT SLIPPED OFF THE BALLOON AND REMAINED IN THE INTRODUCER SHEATH IN THE PT'S RIGHT FEMORAL ARTERY. CO CAN ADVISE WE DO CAUTION, "NEVER ATTEMPT TO PULL AN UNEXPANDED STENT BACK THROUGH THE GUIDING CATHETER. THE STENT MAY BE DISLODGED AND EMBOLIZATION OF THE STENT MAY OCCUR. WITHDRAW THE GUIDING CATHETER, THE STENT/BALLOON CATHETER, AND THE ATERIAL SHEATH AS A SINGLE UNIT LEAVING THE CORONARY WIRE GUIDE IN PLACE."
IN DEPLOYING A 4.0X20 CORONARY STENT IN THE PROXIMAL LAD THE BALLOON WAS INFLATED TO THE APPROPRIATE ATMOSPHERIC PRESSURE. AFTER DEPLOYMENT THE BALLOON WOULD NOT DEFLATE. SEVERAL ATTEMPTS WERE MADE WITH DIFFERENT INFLATION DEVICES AND SYRINGES WITH NEGATIVE PRESSURE. ALL ATTEMPTS WERE UNSUCCESSFUL. THE PT WAS EXPERIENCING SEVERE CHEST PAIN, ACUTE ST ON ECG AND BECOMING UNSTABLE. DECISION WAS MADE TO RUPTURE THE BALLOON USING HIGHER PRESSURE. AT 25 ATM'S THE BALLOON PARTIALLY RUPTURED. ANOTHER INFLATION TO 25 ATM'S WAS DONE TO COMPLETE THE RUPTURE AND THE BALLOON WAS REMOVED. THE ECG CHANGES AND CHEST PAIN RESOLVED SHORTLY AFTER.
AN EXAM FOUND THE RETURNED USED BALLOON CATHETER TO HAVE BEEN MFG ACCORDING TO SPECIFICATIONS. HOWEVER, WE DO CONFIRM THAT THE BALLOON HAS BEEN RUPTURED. AN EVALUATION OF THE INFLATION/DEFLATION PORT REVEALED NO ABNORMALITIES. DUE TO THE BALLOON HAVING BEEN RUPTURED WE WERE UNABLE TO DO ANY INVITRO TESTING. UNFORTUNATELY, WE ARE UNABLE TO DETERMINE WHY DIFFICULTY WAS ENCOUNTERED.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13MMD 3.75MMD IMPLANT WAS PLACED IN THE #19 TO SUPPORT A SINGLE CROWN. THE CROWN WAS PLACED ON 7/12/95 AND FUNCTIONED FOR TWO AND A HALF MONTHS BEFORE THE IMPLANT FAILED TO MAINTAIN OSSEOINTEGRATION AND HAD TO BE REMOVED. THE PERIAPICAL RADIOGRAPH WITH NO DATE, SHOWED A 13MML 3.75MMD IMPLANT IN THE #19 AREA, SUPPORTING A SINGLE CROWN. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE IMPLANT THAN WAS ANTICIPATED. THEREFORE, IT IS RECOMMENDED TO REPLACE THE FAILED IMPLANT WITH A WIDER ONE FOR THE ADD'L SUPPORT.
THE INVESTIGATIVE WORKSHEET STATED THAT A 16MML 3.75MMD IMPLANT WAS PLACED IN THE #13 AND #15 AREA  AND A 13MML 3.75MMD IMPLANT WAS PLACED IN THE #14 AREA OF THE MAXILLA 2/20/95. THE IMPLANTS FAILED TO MAINTAIN OSSEOINTEGRATION AND WERE REMOVED PRIOR TO LOADING. THE PERIAPICAL RADIOGRAPH DATED 2/20/95 SHOWED THE TWO 16MML 3.75MMD IMPLANTS IN THE #13 AND #15 AREAS, AND A 13MML 3.75MMD IMPLANT IN THE #14 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANTS FROM MAINTAINING OSSEOINTEGRATION. EXTERNAL AND SYSTEMOC CAUSED LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE INVESTIGATIVE WORKSHEET STATED THAT A 16MML 3.75MMD IMPLANT WAS PLACED IN THE #13 AND #15 AREAS, AND A 13MML 3.75MMD IMPLANT WAS PLACED IN THE #14 AREA OF THE MAXILLA 2/20/95. THE IMPLANTS FAILED TO MAINTAIN OSSEOINTEGRATION AND WERE REMOVED PRIOR TO LOADING. THE PERIPHERAL RADIOGRAPH DATED 2/20/95 SHOWED THE TWO 16MML 3.75MMD IMPLANTS IN THE #13 AND #15 AREAS, AND A 13MML 3.75MMD IMPLANT IN THE #14 AREA OF THE MAXILLA.  AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD NAVE PREVENTED THESE DENTAL IMPLANTS FROM MAINTAINING OSSEOINTEGATION. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE INVESTIGATIVE WORKSHEET STATED THAT A 16MML 3.75MMD IMPLANT WAS PLACED IN THE #13 AND #15 AREAS, AND A 13MML 3.75MMD IMPLANT WAS PLACED IN THE #14 AREA OF THE MAXILLA 2/20/95. THE IMPLANTS FAILED TO MAINTAIN OSSEOINTEGRATION AND WERE REMOVED PRIOR TO LOADING. THE PERICARDIAL RADIOGRAPH DATED 2/20/95 SHOWED THE TWO 16MML 3.75MMD IMPLANTS IN THE #13 AND #15 AREAS, AND A 13MML 3.75MMD IMPLANT IN THE #14 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THSES DENTAL IMPLANTS FROM MAINTAINING OSSEOINTEGRATION. EXTERNAL AND SYSTEMIC CAUSED LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE INVESTIGATIVE WORKSHEET STATED A 10MML 3.75MMD IMPLANT WAS PLACED IN THE #30 AREA OD THE MANDIBLE ON 9/11/92. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 5/11/93. THE PERIAPICAL RADIOGRAPH EITH NO DATE SHOWED A 10MML 3.75MMD IMPLANT IN THE #30 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
2/96 - FACILITY NOTIFIED VERBALLY BY MFR OF POSSIBILITY OF CORROSION OF HOSE CONNECTIONS AND RESULTING LEAK OF HYDRAULIC FLUID. 3/23/96 CO REP AT FACILITY TO REPAIR UNIT AND TAKE CARE OF HOSE CONNECTIONS. REP DECIDED THAT HOSE CONNECTIONS WERE NOT A PROBLEM AND DID NOT REPLACE THEM. 8/14/96 LEAK OF ALL THE HYDRAULIC FLUID (3 GALLONS) INTO POOL. MSDS STATES THAT FLUID CAN CAUSE SKIN OR EYE PROBLEMS. NO KNOWN PT PROBLEMS.
THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.75MMD IMPLANT WAS PLACED IN THE #19 AREA OF THE MANDIBLE ON 12/28/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 5/6/96. THE PERIAPICAL READIOGRAPH DATED 12/28/95 SHOWED A 10ML 3.75MMD IMPLANT IN THE #19 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSED LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
PT STATED HE WOKE UP WHILE FALLING OUT OF HIS ARM CHAIR INTO A "BALL OF FLAME". PT WAS USING O2 AT 2L/MIN CONTINUOUSLY AS ORDERED AND RECEIVED FIRST DEGREE BURNS TO HIS FACE AND LEFT HAND. FAMILY MEMBER TOLD RPTR THAT PT IS A SMOKER THOUGH PT DENIES, STATING HE HAS QUIT. PT ALSO RECEIVING NURSING CARE FROM LOCAL AGENCY. THEY HAD NOTED SMELL OF SMOKE IN HOME AT EACH VISIT AND HAD TAUGHT PT REGARDING SAFETY HAZARDS. OXYGEN CONCENTRATOR WAS CHECKED BY AN INDEPENDENT ORGANIZATION AND NO DEFECTS WERE FOUND. BOTH CONCENTRATOR AND 50 FT EXTENSION TUBE HAD NO BURN DAMAGE, ONLY CANNULA PRONGS WERE BURNED. PT WAS SEEN AT WALK IN CLINIC, TREATED AND DISCHARGED HOME. EQUIPMENT WAS SWITCHED OUT AND TEACHING WAS REINFORCED.
CO'S LABORATORY'S FTIR ANALYSIS OF THIS YELLOW MATERIAL FOUND IT TO BE CONSISTENT WITH A MEDICATION RESIDUE. SINCE THE TWO NEEDLES CONTAINING THIS SUBSTANCE WERE RETURNED IN OPENED PACKAGES AND THIS MATERIAL IS INCONSISTENT WITH ANY PRESENT IN THE MFG ENVIRONMENT, CO BELIEVES THAT THIS CONTAMINATION DID NOT OCCUR IN A BECTON DICKINSON FACILITY. IN ADDITION, A REVIEW OF FILES REVEALED NO PRIOR INCIDENTS OF THIS TYPE ON THE PRODUCT LOT INDICATED.
THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.75MMD IMPLANT WAS PLACED IN THE #13 AREA OF THE MAXILLA ON 10/23/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 4/19/96. THE 10MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECIFICATIONS. THE PERIAPICAL RADIOGRAPH DATED 10/23/95 SHOWED A 10MML 3.3MMD IMPLANT IN THE #13 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSED LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERSTURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
A FILTER DID NOT OPEN AFTER DEPLOYMENT. A SECOND FILTER WAS SUCCESSFULLY PLACED WITH NO PT COMPLICATIONS. THIS PRODUCT REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. FOLLOW UP REVEALED THAT POST FILMS WERE NOT TAKEN AND CONTINUAL FLUSHING OF THE CARRIER SYSTEM DUYRING THE IMPLANT PROCEDURE WAS NOT PERFORMED. CO BELIEVES THESE EVENTS MAY HAVE CONTRIBUTED TO THIS EVENT.
THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE FILTER WAS NOT RETURNED. THE DELIVERY SYSTEM WAS RETURNED IN A RELEASED POSITION AND A GUIDEWIRE WAS RETURNED IN A HOOP. SINCE THE FILTER REMAINED IMPLANTED A THOROUGH EVAL COULD NOT BE PERFORMED.
PT ADMITTED FOR LABOR AND DELIVERY. EPIDURAL ANESTHESIA PERFORMED. ON ATTEMPTING TO WITHDRAW THE EPIDURAL CATHETER, IT BROKE LEAKING APPROX 6CM OF THE CATHETER IN THE EPIDURAL SPACE. DIR FOR ANESTHESIA SVS AT MFR WAS CONTACTED.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13MML 3.75MMD IMPLANT WAS PLACED IN THE #5 AREA OF THE MAXILLA ON 2/8/95. THE IMPLANT FAILED TO MAINTAIN OSSEOINTEGRATION AND WAS REMOVED ON OR ABOUT 4/96. TEH PERIAPICAL RADIOGRAPH DATED 11/13/95 SHOWED A 13MML 3.75MMD IMPLANT IN THE #5 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAYS AND REVIWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTERGATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION .
DETECTED AN OVERPUMPING OF STERILE WATER, 600ML THROUGH THE NORMAL QA PROCESS. EXPECTED REFRACTIVE INDEX MEASUREMENT: 23.3 (BRIX SCALE), ACTUAL 15.75 BRIX SCALE). CONFIRMED OVERPUMPING BY CALCULATING EXPECTED VOLUME USE OF COMPONENTS TO ACTUAL. LED READ OUT INDICATED APROX VOLUMES HAD BEEN PUMPED. NO AUDIO/VISUAL ALARMS WERE NOTED.
A FILTER DID NOT FULLY DEPLOY OUT OF THE CARRIER CAPSULE DURING A DEPLOYMENT. THE FILTER WAS DEPLOYED AFTER BEING MANIPULATED WITH THE WIRE. FILTER PLACEMENT WAS SUCCESSFUL WITH NO PT COMPLICATIONS. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. FOLLOW UP REVEALED THE WIRE USED FOR PLACEMENT WAS REMOVED BEFORE FILTER DEPLOYMENT. IT WAS INDICATED A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO FILTER PLACEMENT AND CONTINUAL FLUSHING OF THE CARRIER SYSTEM DURING THE IMPLANT PROCEDURE WAS NOT PERFORMED. CO BELIEVES THESE FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT.
ON 8/19 AT 0400 THE WING PILOT PORT WAS FOUND DETACHED FROM THE SHAFT. THE NURSE HAD CHARTED THE PILOT INTACT AT 0300, AT TIME OF TRACH CARE. WHEN ENTERING THE ROOM THE PILOT WAS FOUND DETACHED AND LYING IN THE BED. THE PT HAD NO INCREASED SOB OR ASPIRATION OF SECRETIONS NOTED. THE TUBE WILL BE REMOVED IN THE HOSP DUE TO THE DIFFICULTY OF REMOVING THE FOAM CUFF AND PROBLEMS THAT MAY OCCUR.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13MML 3.75MMD IMPLANT WAS PLACED IN THE #19 AREA OF THE MANDIBLE ON 8/25/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 4/24/96. THE 13MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY EITH THE MFR'S SPECIFICATIONS. THE PERIAPICAL RADIOGRAPH DATED 4/24/96 SHOWED A 13MML 3.75MMD IMPLANT IN THE #19 AREA OFF THE MANDIBLE. AFTER STUDYING TEH X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENWT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSED LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND TEH FOCUS OF THIS INVESTIGATION.
MINOR SURGERY EXCISION OF MULTIPLE MOLES WAS PERFORMED. SUTURE MATERIAL BROKE WHEN KNOTS WERE TIED. THIS OCCURRED WITH THREE PACKAGES.
A FILTER DID NOT OPEN COMPLETELY FOLLOWING DEPLOYMENT VIA A FEMORAL APPROACH. ANOTHER FILTER WAS SUCCESSFULLY PLACED WITHOUT PT COMPLICATIONS. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. FOLLOW UP REVEALED THE PT'S VENA CAVA WAS UNUSUALLY SHORT. AT THIS TIME CO CANNOT DETERMINE IF PT ANATOMY CONTRIBUTED TO THIS EVENT.
IT WAS REPORTED A FILTER DID NOT OPEN COMPLETELY FOLLOWING DEPLOYMENT VIA A FEMORAL APPROACH. ANOTHER FILTER WAS SUCCESSFULLY PLACED WITHOUT PT COMPLICATIONS. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. CO'S FOLLOW UP REVEALED THE PT'S VENA CAVA WAS UNUSUALLY SHORT. AT THIS TIME CO CANNOT DETERMINED IF PT ANATOMY CONTRIBUTED TO THIS EVENT. CO DIRECTIONS FOR USE STATE: "DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGATED FILTER...IN MOST CASES, A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE."
GRAFT IMPLANTED 7/9/96. EXPLANTED 8/9/96 NONFUNCTIONING. SURGEON UNABLE TO RETURN TO FUNCTIONING AND NOTED PERSISTENT COLLAPSE AT VENOUS ANASTAMOSIS SITE. A NEW GRAFT WAS IMPLANTED IN THE OPPOSITE ARM.
PT ARRIVED IN ER WITH CPR IN PROGRESS; PACER PADS PLACED ANTERIORLY AND POSTERIORLY. PT IN V-FIB; DEFIBRILLATED THROUGH PACER PADS X2 WITHOUT PROBLEMS; ON 3RD DEFIBRILLATION ATTEMPT AN ELECTRICAL ARC ON ANTERIOR PAD WAS NOTED. AFTER THIS THE PACER WOULD NOT FUNCTION.
ACCOUNT REPORTED INCIDENT IN NICU IN WHICH DEVICE "BROKE OFF AT CATHETER LUMEN SITE" DURING THE INFUSION OF TPN AND LIPIDS. "NO APPARENT INJURY. SMALL DROPS OF BLOOD NOTED TO BE COMING OUT OF THE LINE."
SECTION F COMPLETED BY CO. NO OTHER INFO IS AVAILABLE. EVALUATION: VISUAL INSPECTION SHOWS THAT THE ONE PIECE MALE LUER LOCK ADAPTER SEPARATED FROM THE TUBING DUE TO INSUFFICIENT SOLVENT.
RPTR FOUND A DEAD BUG IN BETWEEN SPONGES. THE REMAINING SPONGES WERE REMOVED FROM STERILE FIELD.
DURING A VENIPUNCTURE ATTEMPT, THE NEEDLE BROKE OFF IN THE BLOOD TUBE. NOT ENOUGH BLOOD WAS OBTAINED FOR THE SPECIMEN.
ACCOUNT REPORTS INCIDENT WITH 2 YR OLD ONCOLOGY PT IN WHICH "THIN TUBING CAME APART WHERE IT ATTACHES TO LUER LOCK"  DEVICE. A BONE MARROW TRANSPLANT PT HAD DEVICE ATTACHED TO CENTRAL CATHETER. NO PT INJURY REPORTED, HOWEVER, HEALTH CARE PROFESSIONAL WAS "SPLASHED ON HANDS WITH CHEMOTHERAPEUTIC AGENT." NO OTHER INFO AVAILABLE.
SECTION F COMPLETED BY CO. NO OTHER INFO AVAILABLE. EVALUATION: CHARACTETISTIC SAMPLE NOT AVAILABLE AND SPECIFIC L0T NUMBER NOT IDENTIFIED THEREFORE UNABLE TO FURTHER EVALUATE REPORT.
THE INVESTIGATIVE WORKSHEET STATED THAT A 16 MML 3.3. MMD IMPLANT WAS PLACED IN THE #9 AREA OF THE MAXILLA ON 1/24/96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 4/8/96. THE 16 MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PERIAPICAL RADIOGRAPH DATED 8/4/96 SHOWED A 16 MML 3.3 MMD IMPLANT IN THE #9 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
IMMEDIATELY AFTER THE PLACING OF A 4.0 FR PICC, THE PT BEGAN TO HAVE ABDOMINAL CRAMPS. CHEST TIGHTNESS, SOB AND FACIAL STINGING. BP 180/120 HR=110. PT WAS VERY FLUSHED AND ANXIOUS. NORMAL BREATH SOUNDS WITHOUT WHEEZING. PICC PULLED IMMEDIATELY AND ALL SIGNS AND SYMPTOMS GONE WITHIN 5-10 MINS.
WHILE USING A MONITOR/DEFIBRILLATOR/PACER ON THIS PT IN THE EMERGENCY DEPT, PACER FAILED TO WORK PROPERLY. PACER WAS USED WITH ELECTRODES. PACER ALARMED "PADS NOT PRESENT" AFTER 1 OR 2 PACE PULSES. NEW PADS WERE APPLIED WITH SAME NEGATIVE RESULTS.
THE INVESTIGATIVE WORKSHEET STATED THAT A 10 MML 3.7 MMD IMPLANT WAS PLACED IN THE #21 AREA OF THE MANDIBLE ON 3/25/96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 6/16/96. THE 10 MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC RADIOGRAPH DATE 5/2/96 SHOWED A 10 MML 3.7 MMD IMPLANT IN THE #21 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT THE FOCUS OF THIS INVESTIGATION.
PT HAD A CHEST X-RAY ON 8/5/96 WHICH NOTED THAT A FRACTURE HAD OCCURRED THROUGH THE CATHETER WITH A 12.5 CM FRAGMENT OF CATHETER EMBOLIZED INTO THE PULMONARY ARTERY BIFURCATION EXTENDING TO THE LEFT AND RIGHT. CATHETER FRAGMENT WAS REMOVED BY A RADIOLOGIST PER RADIOLOGICAL PROCEDURE ON 8/5/96, REMOVED SURGICALLY ON 8/16/96. ADD'L EXPLANT DATE 8/16/96.
ACCOUNT REPORTED FREE FLOW FROM 2 STATIONS IMMEDIATELY AFTER A NEW TRANSFER SET WAS INSTALLED. THE REPORTER LEARNED THAT THE ACCOUNT DOES NOT ROTATE ROTORS TO SEAT THE TUBING. HE ADVISED USER ON THE PROPER PROCEDURE FOR INSTALLATION, HAVING HER TURN ALL ROTORS TO SEAT THE TUBING AND TO DISCARD THE FINAL BAG THAT WAS HANGING AT THE TIME OF THE FREE FLOW. NO PT INVOLVEMENT. UNIT WAS NOT SWAPPED OUT SINCE THE ISSUE WAS RESOLVED BY TELEPHONE.
SECTION F WAS COMPLETED BY CO, BASED ON INFO OBTAINED FROM INTERVIEW WITH THE REPORTER. EVALUATION: THE PRODUCT SERVICE PERSONNEL CORRECTED THE METHOD USED TO INSTALL TUBING BY HAVING THE USER TURN TO ROTORS. SINCE THE TELEPHONE CONVERSATION RESOLVED THE ISSUE, THE UNIT WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT WAS DUE TO USER TECHNIQUE ERROR.
TEH INVESTIGATIVE WORKSHEET STATED THAT TWO 10MML 3.7MMD IMPLANTS WERE PLACED IN THE #8 AND #9 AREAS OF THE MAXILLA ON 8/1/95. THE IMPLANTS FAILED TO OSSEOINTEGRATE AND WERE REMOVED ON 4/8/96. THE PERIAPICAL READIOGRAPH DATED 4/8/96 SHOWED THE TWO 10MML 3.7MMD IMPLANTS IN THE #8 AND #9 AREAS OF THA MAXILLA. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
PHYSICAN WAS USING A CAST SAW IN A SURGICAL ROOM. PHYSICIAN RECEIVED ELECTRICAL SHOCK FROM CAST SAW. INSPECTION OF THE UNIT REVEALED THAT THE UNIT CONTAINED A WIRING FAULT. DUE TO THE DESIGN OF THE UNIT THE FAULT PRODUCED AN ELECTRICAL SHOCK IN SPITE OF THE USE OF ISOLATED POWER IN THE ROOM. PHYSICIAN RECEIVED NO PERMANENT INJURY AND WAS NOT INCAPACITATED. WIRING FAULT WAS THE RESULT OF IMPROPER SVC BY AN UNKNWON HOSP STAFF MEMBER.
THE INVESTIGATIVE WORKSHEET STATED THAT A 10 MML 3.75 MMD IMPLANT WAS PLACED IN THE #19 AREA AND A 13 MML 3.75 MMD IMPLANT WAS PLACED IN THE #30 AREA OF THE MANDIBLE ON 2/8/96. THE IMPLANTS FAILED TO OSSEOINTEGRATE AND WERE REMOVED ON 4/3/96. THE TWO IMPLANTS THAT WERE INCLUDED WITH THIS REPORT WERE EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANTS WERE FREE FROM ANY DEFECT AND THAT THEY MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC RADIOGRAPH WITH NO DATE SHOWED THE 10 MML 3.75 MMD IMPLANT IN THE #19 AREA, AND THE 13 MML 3.75 MMD IMPLANT IN THE #30 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANTS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
TEH INVESTIGATIVE WORKSHEET STATED THAT TWO 10MML 3.7MMD IMPLANTS WERE PLACED IN THE #8 AND #9 AREAS OF THE MAXILLA ON 8/1/95. THE IMPLANTS FAILED TO OSSEOINTEGRATE AND WERE REMOVED ON 4/8/96. THE PERIAPICAL RADIOGRAPH DATED 4/8/96 SHOWED THE TWO 10MML 3.7MMD IMPLANTS IN THE #8 AND#9 AREAS OF THE MAXILLA. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANTS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
FREE FLOW HAD OCCURRED DURING TWO SUCCESSIVE NIGHTS WHEN THE UNIT WAS SITTING IDLE WITH SOURCE BOTTLES AND TRANSFER SET INSTALLED. THE VOLUME OF FLUID THAT COLLECTED IN THE WEIGHING CHAMBER WAS NOT KNOWN. THERE WERE NO ALARMS SINCE THE UNIT WAS NOT PROGRAMMED TO DELIVER ANY FLUID. SETS WERE DISCARDED SO THERE WAS NO PT INVOLVEMENT. USER WAS ADVISED NOT TO USE THE UNIT WHICH WAS SWAPPED OUT.
EVALUATION: THE UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL ACCURACY TESTS. THE UNIT FAILED CHAMBER GUARD SWITCH TEST. THE COMPLAINT COULD NOT BE DUPLICATED.
DENTAL IMPLANT FAILED.                                                                                                                                                                                                                                                                                                                                                                                                                                    THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.3MMD IMPLANT WAS PLACED IN THE #30 AREA OF THE MANDIBLE ON 5/3/96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 6/12/96. THE PERIAPICAL RADIOGRAPH DATED 5/20/96 SHOWED A 10MML 3.3MMD IMPLANT IN THE #30 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13MML 3.3MMD IMPLANT WAS PLACED IN THE #12 AREA OF THE MAXILLA ON 1/17/96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 4/10/96. THE 13 MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PERIAPICAL RADIOGRAPH DATED 1/17/96, SHOWED A 13 MML 3.3 MMD IMPLANT IN THE #12 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAYS AND REVIEWING REPORTS, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
FEMORAL BRUSH BRISTLE PARTICLES BROKE OFF INTO WOUND. THE SURGEON REMOVED THE PARTICLES AND IRRIGATED THE WOUND WELL.
THE DEVICE WAS USED ON A LAP/GYN PROCEDURE. REPORTEDLY, THE DEVICE'S SAFETY SHIELD FAILED TO RETRACT TO ALLOW FOR PENETRATION. THE SURGEON USED ANOTHER DEVICE. THE HOSP HAS REPORTED NO PT INJURY.
RPTR RECEIVED 2 BOXES OF SODIUM FLUORIDE TUBES. THE BOXES WERE UNDAMAGED, BUT UPON OPENING IT WAS DISCOVERED THAT MOST OF THE TUBES WERE FLATTENED OR COLLAPSED.
DURING DEFIBRILLATION RESUSCITATION, THE DEFIBRILLATOR CHARGED UP BUT WOULD NOT DISCHARGE. LATER INVESTIGATION REVEALED THAT THE SWITCH TO DISCHARGE THE DEFIBRILLATOR HAD FAILED IN THE STERNUM SIDE OF THE PADDLE. ANOTHER DEFIBRILLATOR WAS NEAR BY AND THE PT WAS NOT AFFECTED BY THE MALFUNCTION.
THE DEVICE WAS USED ON A LAP/GYN PROCEUDRE. REPORTEDLY, THE DEVICE SAFETY SHIELD FAILED TO RETRACT TO ALLOW FOR PENETRATION. THE SURGEON USED ANOTHER DEVICE. THE HOSP HAS REPRTED NO PT INJURY.
RPTR C/O LEAKING OF LEFT BREAST IMPLANT; KNOTS IN BOTH BREASTS, POSSIBILITY OF BONE CANCER, AND MENTAL AND EMOTIONAL STRESS. IMPLANT DATE: 3/24/86.
PLAINTIFF ALLEGES LATEX POISONING INCLUDING, WITHOUT LIMITATION, AS ASTHMA-LIKE REACTION. PLAINTIFF'S HUSBAND ALLEGES THAT DUE TO PLAINTIFF'S ALLEGED LATEX POISONING, HAS BEEN DEPRIVED OF LOVE, SERVICES, ADVICE, COMPANIONSHIP AND CONSORTIUM OF HIS WIFE.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE ANY PRODUCT IDENTIFICATION OR LOT NUMBER INFO. LITIGATION PENDING, NO CUSTOMER CONTACT ALLOWED.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE ANY PRODUCT IDENTIFIACTION OR LOT NUMBER INFO. LITIGATION PENDING, NO CUSTOMER CONTACT ALLOWED.
THE DEVICE WAS USED ON A LAP/GYN PROCEDURE. REPORTEDLY, THE DEVICE SAFETY SHIELD FAILED TO RETRACT TO ALLOW FOR PENETRATION. THE SURGEON USED ANOTHER DEVICE. THE HOSP HAS REPORTED NO PT INJURY.
THIRD OCCURRENCE OF 4MM ANGLED MENISCUS SHAVER HAVING PIECES OF METAL CHIPPED OFF INTO JOINT. BIOMEDICAL PEOPLE HAVE CHECKED OUT EQUIPMENT AND REPORT IT IS FUNCTIONING PROPERLY.
THE DEVICE WAS APPLIED DURING A COLOCOLOSTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE TISSUE AT THE STAPLE LINE AND APPLIED ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THE PT STATUS IS SATISFACTORY.
LEFT REAR LEG OF PORTABLE COMMODE FAILED AND BENT WHILE PT WAS USING DEVICE. SUPPORT LEG BENT INWARD AT UPPER CROSS-BRACE CONNECTING POINT. PROBABLE CAUSE OF FAILURE WAS DUE TO OVERSTRESS AT CONNECTING POINT OF CROSS-BRACE. PT STATED THAT SHE WAS "JUST SITTING" ON THE COMMODE. AND THE LEG COLLAPSED, CAUSING HER TO FALL FORWARD. DEVICE WAS PLACED ON A CARPETED SURFACE DURING USE.
THE DEVICE WAS APPLIED DURING A JEJUNAL FREE FLAP PROCEDURE INVOLVING ONE PT. REPORTEDLY THE DEVICE MISFIRED. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
IN THE OR, PRIOR TO SURGERY AND DURING THE EQUIPMENT CHECK-OUT, THE UNIT AUTOMATICALLY ACTIVATED ON POWER-UP.
PLAINTIFF ALLEGES INJURY TO BODY AND SHOCK INJURY TO NERVOUS SYSTEM INCLUDING SEVERE ILLNESS AND INJURIES TO THE SKIN, AND ORGANS, INCLUDING BUT NOT LIMITED TO THE SKIN DISCOLORATION, SORENESS AND/OR RASHES.
TEH IMVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE ANY PRODUCT IDENTIFIACTION OR LOT NUMBER INFO. LITIGATION PENDING, NO CUSTOMER CONTACT ALLOWED.
DEVICE WAS USED DURING A GASTRECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE DEVICE WOULD NOT FIRE. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE. THE HOSP HAS REPORTED NO PT INJURY.
DEVICE EVALUATION INDICATED AS "NOT RETURNED TO MFG" IN H3 AND THE APPROPRIATE CODES WERE ENTERED IN H6.
DEVICE WAS USED DURING A SUBTOTAL GASTRECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE ANCHOR BLOCK BROKE DURING CLAMPING. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
THE CLINICALLY APPLIED STAPLER WAS RETURNED AND EVALUATED. DAMAGE WAS OBSERVED TO THE GEAR HANDLE TEETH. WE CANNOT RELIABLY DETERMINE THE EXACT CAUSE OF THIS DIFFICULTY REPORTED OR THE DAMAGE OBSERVED AS THE CLINICALLY APPLIED DISPOSABLE LOADING UNIT WAS NOT RETURNED FOR EVAL.
STAFF MEMBER SUSTAINED BURN TO THE RIGHT FINGER AND THUMB UPON DISCONNECTING ELECTRO CAUTERY PENCIL FROM THE MACHINE. THE BURN WAS CONSIDERED MINOR. ICE WAS APPLIED AND SILVADENE CREAM.
PATIENT CODE # 1757 - NO LABELING. DEVICE CODE #1117 - NO LABELING. D.6. MODEL #: IN THIS EVENT, THE MODEL IS A NAME, NOT A NUMBER. A.1., A.2., A.3., & A.4: IT IS MY UNDERSTANDING THAT WHEN THE INJURY IS CONSIDERED VERY MINOR AND FALLS UNDER A MALFUNCTION REPORT, THEN PATIENT INFORMATION IS NOT REQUIRED. LET ME KNOW IT I AM WRONG.
CUSTOMER WAS MISDIAGNOSED BY A DR IN 1988 AS HAVING LUPUS WHEN SHE BEGAN TO EXPERIENCE RASH, BREATHING DIFFICULTY AND SORES THE SIZE OF A QUARTER THAT WEEPED CLEAR FLUID FOR 5-6 MONTHS. SHE TOOK PREDNISONE AND HAD BLOOD GLUCOSE PROBLEMS. SHE IS ON INSULIN. IN 9/95 SHE WAS DIAGNOSED AS HAVING LATEX SENSITIVE WHEN SHE HAD ANAPHYLACTIC SHOCK DURING A PATCH TEST. FINGERS ARE LIKE TISSUE PAPER. SKIN JUST PEELS OFF AND SHE HAS LOST HER NAILS. CUSTOMER IS SUING THE MFR.
THE INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT CATALOG NUMBER OR LOT NUMBER INFO PROVIDED.
ALLEGEDLY DURING PT USE, THE DEFIBRILLATOR INTERMITTENTLY FAILED TO CHARGE. A BACK UP DEVICE WAS AVAILABLE AND USED TO CONTINUE TREATMENT. PT OUTCOME UNKNOWN.
SECTION A. NUMEROUS ATTEMPTS WERE MADE FTO ACQUIRE PT INFORMATION FROM THE DREPORTER. ALL ATTEMPTS WERE UNSUCCESSFUL. AN EXAMINIATION OF THE MAIN PRINTED CIRCUTI BOARD REMOVED FROM THE DEVICE DETERMINED INTERGRATED CIRCUIT U23 EXHIBITED INTERMITTENT OPERATION DUE TO BROKEN INTERNAL CONNECTIONS. THIS COMPONENT DISCREPANCY IS CONSISTANT WITH ALLEGED INTERMITTENT FAILURE OF THE DEFIBRILLATOR TO CHARGE.
DEVICE WAS USED DURING A LAPARASCOPIC VERTICAL BANDED GASTROPLASTY. IT WAS REPORTED THAT THE PT WITH A THICK ABDOMINAL WALL WAS OPERATED WITH A VBG. THE FIRST DEVICE WAS USED AS THE COMMON PORT, BREAKAGE WAS NOTICED. SEVERAL PIECES WERE FOUND IN THE ABDOMINAL CAVITY, THE PIECES WERE RETRIEVED FROM THE OTHER PORT SITES. THE DEVICE WAS REPLACED WITH THE SECOND DEVICE WHICH ALSO BROKE, THE SURGEON THEN CONVERTED TO THE OPEN PROCEDURE.
RESULTS OF EVALUATION: CONCLUSION: A,B) BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE SLEEVES WERE "BROKEN" DURING SURGERY. INSTRUMENT "A" WAS SHATTERED DISTALLY, AND ALL THE PIECES COULD NOT BE ACCOUNTED FOR. INSTRUMENT "B" WAS BROKEN 1" DISTAL TO THE HOUSING/CANNULA WELD. THE OBTURATORS WERE NOT RECEIVED FOR ANALYSIS. C-F) THESE INSTRUMENTS WERE RECEIVED IN UNOPENED BLISTER PACKS. THE INSTRUMENTS WERE EXAMINED AND FOUND TO BE CONFORMING.
DEVICE WAS USED DURING A PNEUMONECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, STAPLES DID NOT FORM PROPERLY DURING APPLICATION RESULTING IN BLEEDING FROM THE STAPLE LINE. THE APPLICATION SITE WAS OVERSEWN AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE HOSP HAS REPORTED NO PT INJURY.
1/22/97 - SUPPLEMENTAL REPORT #3 SENT TO FDA. IT HAS COME TO CO'S ATTENTION THAT ON JANUARY 10, 1997, A SUPPLEMENTAL REPORT WAS CORRECTLY SUBMITTED UNDER THIS REGISTRATION NUMBER. PLEASE DISREGARD THAT REPORT AND REFER TO THE ONE SUBMITTED ON SEPTEMBER 24, 1996 FOR THE CORRECT INFORMATION.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN 3 IMPLANTS WERE PLACED IN CLASS II BONE IN A HIGHLY COMPLEX PROCEDURE ENTAILING MANDIBULAR NERVE LATERALIZATION. THE CLINICIAN REPORTS THAT INFECTION DEVELOPED AROUND THE IMPLANT SITED AND THAT THE IMPLANTS IN SITE NUMBERS 29 AND 31 DID NOT INTEGRATE AND WERE REMOVED APPROX. 6 WEEKS POST OPERATIVELY. ACCORDING TO THE CLINICIAN THE REMAINING IMPLANT IS STABLE.
MFR DEVICE EVALUATION TO FOLLOW AT A LATER DATE. ADD'L INFO REPORT WILL BE FILED AT THAT TIME.
THORACENTESIS WAS PERFORMED. AT THE END OF THE PROCEDURE WHEN THE CATHETER WAS REMOVED THE TIP SHEARED OFF AND REMAINED IN THE PT. X-RAY REVEALED THE RETAINED TIP AND THE PT REQUIRED SURGICAL INTERVENTION.
DEVICE HISTORY SEARCH COULD NOT BE CONDUCTED AS THERE WAS NOA L/N REPORTED. IN SIMILAR INCIDENTS IN WHICH THE CATHETER WAS WITHDRAWN THROUGH THE NEEDLE THE CATHETER WAS SHEARED. THE DIRECTIONS FOR USE INCLUDE "WARNING: DO NOT WITHDRAW OR PULL BACK CATHETER THROUGH NEEDLE AT ANY TIME. THE CATHETER CAN BE SEVERED BY THE NEEDLE CAUSING POSSIBLE PT INJURY."  CO HAS TRIED TO MITIGRATE THIS PROBLEM BY ENCLOSING A BUTTERFLY CLAMP TO LOCK THE CATHETER, SO IT CANNOT BE REMOVED THROUGH THE NEEDLE.
AMBULANCE PERSONNEL WERE ATTENDING A PT THAT HAD REPORTEDLY BEEN DOWN FOR AN UNKNOWN AMOUNT OF TIME WITHOUT CPR. A RHYTHM ANALYSIS WAS REQUESTED AND A SHOCK ADVISED DECISION WAS RENDERED. ALLEGEDLY THE DEVICE WOULD NOT CHARGE. THE OPERATOR CHANGED THE BATTERY AND REQUESTED A SECOND ANALYSIS. THE DEVICE RENDERED A NO SHOCK ADVISED DECISION. THE PT WAS NOT RESUSCITATED. THE RPTR STATED THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THIS OPINION WAS BASED ON THE RPTR'S ASSESSMENT OF THE PT'S VIABILITY.
CO COMPLETED PERFORMANCE AND FUNCTIONAL TESTS ON THE DEVICE AND OBSERVED PROPER OPERATION. A REVIEW OF THE ERROR MESSAGE LOG REVEALED AN ERROR CODE 11 AND 51 LOGGED ON THE DATE OF THE REPORTED EVENT, HOWEVER, THE ERROR CODES WERE NOT DUPLICATED DURING TESTING. THE OPERATING SOFTWARE WILL BE REPLACED TO ENHANCE CUSTOMER CONFIDENCE IN THE DEVICE AND THE UNIT RETURNED TO THE CUSTOMER FOR USE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT LOAD OR FORM PROPERLY, THE SURGEON APPLIED ANOTHER DEVICE AND THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN 6 IMPLANTS WERE PLACED DURING A HIGHLY COMPLEX PROCEDURE ENTAILING PLACEMENT IN A THIN RIDGE IN CONJUNCTION WITH A SINUS AUGMENTATION IN CLASS III TO CLASS IV BONE. THEEH IMPLANT IN SITE #13 WAS PLACED IN AN IMMEDIATE EXTRACTION SITE. THE CLINICIAN SUBMITS THAT THE IMPLANT WAS PLACED ABOUT 1 CM HIGHER THANT THE OTHERS AND THAT IT WAS "PROBABLY A PIVOT POINT". THE IMPLANT IN SITE #13 WAS REMOVED APPROX. 1 MONTH POST-OPERATIVELY. THE CLINICIAN REPORTER THAT THE REMAINING 5 IMPLANTS ARE STABLE.
MFR DEVICE EVALUATION TO FOLLOW AT A LATER DATE. ADD'L INFO APART WILL BE FILED AT THAT TIME.
DEVICE WAS USED DURING A LAPAROSOCPIC CHOLECYSTECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE DEVICE PRODUCED MALFORMED CLIPS. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
10/24/96- SUBMISSION OF SUPPLEMENTAL REPORT #1 TO FDA BY MFG.
WITHIN 6-10 MINUTES ON ONSET OF TREATMENT, THE PT EXPERIENCED CHEST PAIN WHICH RADIATED TO BACK AND GROIN. TREATMENT WAS DISCONTINUED AND RESTARTED ON A DIALYZER OF ANOTHER MFR WITH NO PROBLEMS. PT'S CONDITION IS OKAY; IT WAS THE PT'S FIRST TREATMENT WITH CO DIALYZER.
THE RETURNED UNT FROM THE SAME LOT NUMBER WAS RETURNED TO THE FACTORY AND TESTED FOR PYROGENS, ACUTE SYSTEMIC TOXICITY, INTRACUTANEOUS TOXICITY AND HEMOLYSIS; NO ABNORMALITY WAS OBSERVED. STERILITY AND PYROGEN TESTS ARE ROUTINELY TESTED PRIOR TO SHIPMENT; THE RECORDS FOR THIS LOT WERE REVIEWED AND NO ABNORMALITY WAS OBSERVED.
PHYSICIAN WAS STARTING TO REMOVE THE CATHETER AND A PIECE SHEARED OFF. PT STATED EXPERIENCING SHORTNESS OF BREATH AND WAS TAKEN TO SURGERY FOR REMOVAL OF THE PIECE OF CATHETER IN THE THORACIC AREA. A THORACOSTOMY PROCEDURE WAS PERFORMED.
A DEVICE HISTORY SEARCH WAS CONDUCTED. THERE WAS NO INFO THAT WOULD INDICATE THAT A PROBLEM WAS FOUND EITHER IN PRODUCTION OR RAW MATERIAL INSPECTIONS. THREE" OF THE SEVERED CATHETER WAS RETURNED AND VISUAL EXAM CONFIRMS SHEARING. THE DIRECTIONS FOR USE INCLUDE "WARNING: DO NOT WITHDRAW OR PULL BACK CATHETER THROUGH NEEDLE AT ANY TIME. THE CATHETER CAN BE SEVERED BY THE NEEDLE CAUSING POSSIBLE PT INJURY." CO HAS TRIED TO MITIGATE THIS PROBLEM BY ENCLOSING A BUTTERFLY CLAMP TO LOCK THE CATHETER, SO IT CANNOT BE REMOVED THROUGH THE NEEDLE.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO CLINICIAN 4 IMPLANTS WERE PLACED DURING A COMPLEX PROCEDURE ENTAILING AN AUTOGENOUS BONE GRAFT IN CLASS II BONE. THE CLINICIAN REPORTS THAT THE PT WAS WEARING A PARTIAL OVER THE IMPLANT IN SITE #10 DURING THE HEALING PHASE AND SUBMITS THAT IT MAY HAVE BEEN PUTTING PRESSURE ON THE IMPLANT. THE CLINICIAN REPORTS THAT THE IMPLANT IN SITE #10 WAS REMOVED 3 MONTHS POST-OPERATIVELY. ACCORDING TO THE CLINICIAN THE REMAINING 3 IMPLANTS ARE STABLE.
THE CHAIR TIPPED AS STAFF WAS LOWERING A FEMALE PT INTO THE BATH. SHE WAS MOBILE ENOUGH TO GET OFF THE CHAIR. NO INJURY TO PT OR STAFF.
THE FOLLOWING IS A CLOSING OUT REPORT BY THE FOREIGN REPORTER'S INVESTIGATOR. INVESTIGATION: THE LIFT WAS EXAMINED BUT NO FAULTS COULD BE FOUND. THIS LIFT HAS BEEN USED IN THE SAME ROOM WITH A HILO BATH MANY TIMES BEFORE. OBSERVATIONS: THE INVESTIGATOR HAS OFFERED A POSSIBLE EXPLANATION OF EVENTS - THE JIB WAS LOWERED TOO FAR, THE CHAIR TOUCHED THE BOTTOM OF THE BATH AND MOVED AWAY FROM THE JIB LOCATION. WHEN THE LIFT WAS RAISED THE CHAIR WAS NOT LOCATED PROPERLY ON THE JIB AND THE MOVEMENT OF THE CHAIR RE-ALIGNMENT ITS SELF. FACILITY AGREED THIS WAS POSSIBLE. CONCLUSIONS: USER ERROR. HOIST LOWERED TO FAR. CORRECTIVE ACTION: HOSIT HAS BEEN PUT BACK INTO SERVICE, AND STAFF NOT UNDERSTANDS THE PROBLEMS IT THE HOIST IS LOWERED TOO FAR.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO CLINICIAN THE IMPLANT DID NOT ACHIEVE PRIMARY STERILITY WHEN PLACED IN SITE NUMBER 30 IN CLASS IV BONE. THE CLINICIAN REMOVED THE IMPLANT DURING THE SAME PROCEDURE.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. ACCORDING TO THE CLINICIAN 4 IMPLANTS WERE PLACED IN THE MANDIBLE DURING A ROUTINE PROCEDURE IN CLASS II BONE. THE CLINICIAN REPORTS THAT THE IMPLANTS IN SITE NUMBERS 18 AND 19 DID NOT INTEGRATE AND WERE REMOVED APPROX. 2 1/2 MONTHS POST-OPERATIVELY. ACCORDING TO THE CLINICIANS THE REMAINING 2 IMPLANTS ARE STABLE.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
AMBULANCE PERSONNEL WERE ATTEMPTING TO TREAT A PULSELESS. APNEIC PT THAT HAD BEEN SHOCKED TWICE BY THE FIRST RESPONDERS. THE PT WAS THEN HOOKED UP TO THE AMBULANCE'S DEVICE AND WAS DIAGNOSED TO BE ASYSTOLIC. LOW BATTERY LED#1 IMMEDIATELY ILLUMINATED AND THE OPERATOR SWITCHED TO ANOTHER BATTERY. AN ATTEMPT WAS MADE TO EXTERNALLY PACE THE PT. HOWEVER ALLEGEDLY THE CRT BLANKED MOMENTARILY AND THE UNIT WOULD NOT PACE. THE OPERATOR SUCCESSFULLY SHOCKED THE PT TWICE AND THE PT WAS RESUSCITATED.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. ACCORDING TO THE CLINICIAN 2 IMPLANTS WERE PLACED IN SITE NUMBERS 23 AND 26 DURING A ROUTINE PROCEDURE IN CLASS II BONE. THE CLINICIAN REPORTED THAT THE IMPLANTS DID NOT INTEGRATE AND WERE REMOVED APPROX. 8 MONTHS POST-OPERATIVELY.
DURING A LOW ANTERIOR RESECTION PROCEDURE, ON ONE PT. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE STAPLE LINE AND APPLIED MANUAL SUTURE. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN 4 IMPLANTS WERE PLACED IN CLASS III BONE IN SITE NUMBERS 3,6,11, AND 14 ON 12/14/94. IN A PREVIOUS REPORT (M#710733) THE IMPLANTS IN SITE NUMBERS 3 AND 14 WERE REMOVED BECAUSE THEY DID NOT INTEGRATE. AT THIS TIME THE CLINICIAN REPORTS THAT THE IMPLANT IN SITE NUMBER 11 HAS LOST INTEGRATION AND WAS REMOVED ON 7/10/96. THE CLINICIAN REPORTS THAT THE REMAINING IMPLANT IS STABLE.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMED THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
THE DEVICE CRT DISPLAY "BLOOMED OUT" AND BLANKED WHILE MONITORING A PT. ACCORDING TO THE RPTR, THE EVENT DID NOT ADVERSELY AFFECT PT CARE.
EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFORMATION ON THIS EVENT TO FDA.
THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER. FEMALE PT IS 79 YRS OLD AND WEIGHS 107 LBS.
UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN THE IMPLANT WAS PLACED IN SITE #14 DURING A HIGHLY COMPLEX PROCEDURE ENTAILING AUTOGENOUS BONE AUGMENTATION IN CONJUNCTION WITH A SINUS LIFT PROCEDURE IN CLASS IV BONE. THE CLINICIAN REPORTS THAT THE IMPLANT DID NOT INTEGRATE AND WAS REMOVED APPROX. 6 WEEKS POST-OPERATIVELY.
DEVICE WAS USED DURING A LOBECTOMY PROCEDURE ON ONE PT. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE STAPLE LINE AND APPLIED ANOTHER DEVICE. THE PT'S STATUS IS SATISFACTORY.
THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN THE IMPLANT WAS PLACED IN SITE #14 DURING A ROUTINE PROCEDURE IN CLASS III BONE. THE CLINICIAN REPORTS THAT THE IMPLANT PLACEMENT PENETRATED THE SINUS, RESULTING IN RECURRENT SINUS PAIN. ACCORDING TO THE CLINICIAN THE IMPLANT WAS REMOVED APPROX. 7 1/2 MONTHS POST-OPERATIVELY AND THE PT IS DOING WELL.
AFTER IABP FOR TWO DAYS, THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER.
UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. FURTHER LABORATORY EXAMINATION REVEALED NO DEFECTS IN THE RETURNED PRODUCT.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN THE IMPLANT WAS PLACED IN SITE NUMBER 30 DURING A ROUTINE PROCEDURE IN CLASS III BONE. THE CLINICIAN REPORTS THAT THE IMPLANT DID NOT INTEGRATE AND WAS REMOVED APPROX 6 WEEKS POST-OPERATIVELY.
DEVICE WAS USED DURING A LOBECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE STAPLE LINE AND APPLIED ANOTHER DEVICE. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.
6/6/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 8/1/96. PATIENT'S CURRENT STATUS: UNK - REPORTED 8/1/96.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN 5 IMPLANTS WERE PLACED DURING A ROUTINE PROCEDURE IN CLASS III BONE. THE CLINICIAN REPORTS THAT THE PLACEMENT OF THE IMPLANT IN SITE #9 PENETRATED THE NEED CAVITY. ACCORDING TO THE CLINICIAN BE ELECTED TO REPLACE THE IMPLANT WITH A SHORTER IMPLANT THE FOLLOWING DAY. THE CLINICIAN REPORTS THAT THE PT IS DOING WELL.
ALLEGED EROSION. FOLLOW-UP FINDINGS: INFECTION OF UNK ETIOLOGY WITH EXTRUSION.
PT'S NAME IN "E1" SECTION IS NOT PROVIDED TO MAINTAIN CONFIDENTIALITY. DEVICE EVAL METHOD CODE 86= DEVICE WAS NOT RETURNED FOR EVAL.
THE IAB LEAKED DURING INSERTION. THE IAB WAS REMOVED AND A SECOND WAS INSERTED.
THE IAB WAS INSERTED INTO THE PT ON 7/29/96. ON 8/2/96 AFTER IABP FOR ABOUT FOUR DAYS, THE "GASS LOSS" ALARM SOUNDED FROM THE CO'S PUMP. THE PUMP WAS CHANGED TO ANOTHER MODEL. THE PT WENT TO SURGERY AND THE PUMP WAS CHANGED BACK TO THE SAME PUMP. THE "BLOOD ALARM" SOUNDED BUT NO BLOOD WAS NOTED. WHEN THE IAB WAS REMOVED, "BROWN FLECKS" WERE NOTED IN THE IAB MEMBRANE. A SECOND IAB WAS INSERTED.
A PT RECEIVED HER FIRST TREATMENT ON 5/20/96 IN THE NASOLABIAL FOLDS. ON 5/21/96, THE PT NOTED AND PRESENTED WITH ERYTHEMA AND SWELLING AT THE TREATMENT SITES. THE PHYSICIAN DIAGNOSED A POSSIBLE HYPERSENSITIVITY; ORAL KEFLEX WAS PRESCRIBED. ON 8/12/96, THE SYMPTOMS WERE RESOLVED; THE EXACT DATE OF RESOLUTION WAS UNK.
THE BALLOON DID NOT INFLATE. THE IAB WAS NOT RETURNED TO CO FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVALUATION. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. THIS FORM WAS COMPLETED BY THE MFR.
DEVICE LABEL CODES: 1738 1701. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECTED TO A NON-PREDUCTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY.
NO ALARMS SOUNDED. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 8/6/96; UNK-REPORTED 11/7/96. PATIENT'S CURRENT STATUS; UNK-RPT'D 11/7/96.
A PT WAS RETESTED ON 8/12/96 IN THE LEFT CHEEK. ON 8/13/96 THE PT NOTED AND PRESENTED WITH ERYTHEMA, SWELLING, AND TENDERNESS AT THE RETEST SITE. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY; ORAL KEFLEX WAS PRESCRIBED. IN 8/17/96, THE SYMPTOMS HAD IMPROVED.
ON 5/6/97, FOLLOW UP INFO FROM THE PHYSICIAN WAS THAT THE SYMPTOMS RESOLVED ON 8/17/96.
A PT RECEIVED HER FIRST TREATMENT ON 8/7/96 INTO THE PERIORBITRAL AREAS, VERTICAL LINES ABOVE THE UPPER LIP AND THE CORNERS OF THE MOUTH. ON APPROX 8/19/96, THE PT DEVELOPED SWELLING AND ITCHING AT THE COLLAGEN TREATMENT SITES ON THE LEFT SIDE OF HER FACE. SHE WAS SEEN ON BY THE PHYSICIAN 8/27/96 WITH SYMPTOMS PRESENT; HE DIAGNOSED A HYPERSENSITIVITY AND PRESCRIBE ORAL BENADRYL.
THE DR REMOVED THE INNER LUMEN STYLET WIRE BY RELEASING THE LUER-LOCK FITTING AND PULLING STRAIGHT BACK. WHEN THIS WAS DONE, THE STYLET WIRE KNOB BROKE OFF FROM THE STYLET WIRE.
PRODUCT RETURNED FOR EVALUATION. INVESTIGATION NOT YET COMPLETED.
A PT RECEIVED HER FIRST TREATMENT ON 7/1/94 IN THE NASOLABIAL FOLDS. IN LATE 8/94 (EXACT DATE UNKOWN), THE PT NOTED INTERMITTENT REDNESS AND SWELLING AT THE NASOLABIAL FOLDS. ON 9/16/94, THE PT PRESENTED WITH ERYTHEMA AND SWELLING AT THE NASOLABIAL FOLDS. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY; NO MEDICAL OR SURGICAL INTERVENTION WAS PRESCRIBED. THE SKIN TEST SITE REMAINED ASYMPTOMATIC. ON 8/29/96, THE PT ALLEGED THAT REDNESS AND LUMPINESS INTERMITTENTLY FLARED AT THE NASOLABIAL FOLDS; THE LAST FLARE WAS APPROX 8/15/96. THE PT DID NOT SEEK MEDICAL CARE FOR THE SYMPTOMS.
THE PHYSICIAN UNSCREWED THE CLEAR HEMOSTASIS VALVE ASSEMBLY FROM THE SHEATH HUB INSTEAD OF UNSCREWING JUST THE BLUE DILATOR. THIS LED THE USER TO PERCEIVE THAT THE HEMOSTASIS VALVE WAS NOT WORKING PROPERLY BECAUSE A LARGER QUANTITY OF BLOOD CAME FROM THE SHEATH.
THE PRODUCT WAS RETURNED FOR EVALUATION. THE INVESTIGATION IS NOT YET COMPLETED.
THE IAB WAS INSERTED INTO THE PT ON 7/26/96. ON 7/31/96 AFTER IABP FOR ABOUT FIVE DAYS, A SMALL LEAK WAS DETECTED DURING THE NIGHT. A "SMALL LEAK" ALARM SOUNDED FROM THE PUMP. THE PUMP WAS PUT ON OVERRIDE FOR APPROX FIVE HRS AND THEN THE IAB WAS REMOVED.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN 4 IMPLANTS WERE PLACED IS SITE NUMBERS 6,7,10, AND 11 DURING A HIGHLY COMPLEX PROCEDURE ENTAILING PLACMENT IN A NARROW BONE RIDGE IN CONJUNCTION WITH FREEZE-DRIED BONE AUGMENTATION CLASS III BONE. THE CLINICIAN REPORTS THAT THE PLACEMENT OF THIS IMPLANT IN SITE #10 WAS COMPROMISED DUE TO THE ROOT PROXIMITY TO THE TOOTH IN SITE #9. ACCORDING TO THE CLINICIAN THE IMPLANT IN SITE #10 WAS LOOSE APPROX. 10 MONTHS POST-OPERATIVELY AND WAS REMOVED AT THAT TIME. THE CLINICIAN REPORTS THAT THE REMAINING 3 IMPLANTS ARE STABLE.
A PT WAS TREATED ON 6/14/96 FOR VOCAL CORD AUGMENTATION. THE PHYSICIAN STATED HE INJECTED TOO MUCH MATERIAL, RESULTING IN OVERCORRECTION AND ALTERATION OF THE PT'S VOICE. ON 8/30/96, THE IMPLANT WAS SURGICALLY REMOVED.
ON 4/3/97, A FOLLOW UP CALL REVEALED THAT THE PROBLEM WAS FIXED AND EVERYTHING WAS RESOLVED WITH THE PATIENT.
THE IAB WAS INSERTED INTO THE PT ON 8/5/96 AT 9:00 AM. ON 8/6/96 AT 4:00 AM, THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING AND THE BALLOON WAS REMOVED.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPOERTER OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. DEVICE LABELING CODE: 1738.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN 2 IMPLANTS WERE PLACED IN SITE NUMBERS 2 AND 3 DURING A ROUTINE PROCEDURE IN CLASS IV BONE. THE CLINICIAN REPORTS THAT THE IMPLANT IN SITE # 2 DID NOT INTEGRATE AND WAS REMOVED APPROX. 2 MONTHS POST-OPERATIVELY. ACCORDING TO THE CLINICIAN THE REMAINING IMPLANT IS STABLE.
AN ALARM SOUNDED FROM THE CO'S PUMP AND BLOOD WAS NOTED IN THE CATHETER.
THE IAB WAS INSERTED INTO THE PT ON 7/19/96. ON 7/25/96 AFTER IABP FOR SIX DAYS BLOOD WAS NOTED BACK IN THE SAFETY CHAMBER. NO "SLOW GAS LOSS" ALARM SOUNDED FROM THE PUMP.
UNDERWATER LEAK TESTING REVISED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN 3 IMPLANTS WERE PLACED IN SITE NUMBERS 19,20, AND 21 DURING A ROUTINE PROCEDURE IN CLASS III BONE. THE CLINICIAN REPORTS THAT THE IMPLANT IN SITE #20 DID NOT INTEGRATE AND WAS REMOVED APPROX. 6 WEEKS POST-OPERATIVELY. ACCORDING TO THE CLINICIAN THE REMAINING 2 IMPLANTS ARE STABLE.
EARLY IN THE MORNING OF 7/10/96 A 17 YEAR OLD MALE WITH CEREBRAL PALSY LIVING AT HOME APPARENTLY CHOKED TO DEATH ON A PIECE OF MATERIAL WHICH HE TORE FROM A DISPOSABLE INCONTINENCE PROTECTIVE GARMENT HE WAS WEARING. THE INDIVIDUAL ONLY WORE INCONTINENCE GARMENTS FOR OVERNIGHT USE AND HE HAD BEEN OBSERVED PICKING AT THE PRODUCT PRIOR TO THE INCIDENT.
THIS FORM CONTAINS INFO REPORTED TO KIMBERLY-CLARK CORPORATION OR ONE OF ITS SUBSIDIARIES AND MAY NOT, AFTER FURTHER INVESTIGATION, REPRESENT ACTUAL FACT. NEITHER THE SUBMISSION OF THIS OR OTHER INFO TO THE FDA PURSUANT TO 21 CFR 803, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
THE CONTACT AT THE FACILITY STATED THAT THE IAB WAS "TOO SHORT" FOR THE PT BECAUSE OF THE NEW CHANGES MADE TO THE PRODUCT.
THE CATHETER LENGTH WAS MEASURED AND FOUND TO BE WITHIN DATASCOPE'S MFG SPECIFICATIONS. THE BALLOON PUMPED SATISFACTORILY ON THE LAB SYSTEM 90 AT 80 AND 160 BPM. NO ALARMS WERE TRIGGERED. NO DEFECT WAS FOUND IN THE DEVICE.
ON 7/20/96, PT HAD ABDOMINAL EXPLORATION. SEVEN MM FLAT DRAIN INSERTED. APPROX 7/19/96, DRAIN WAS REMOVED LEAVING A PORTION RETAINED IN PT, WHICH WAS SURGICALLY REMOVED 7/20/96.
EVALUATION RESULTS- THE SAMPLE DRAIN FRACTURED AT THE PERFORMATION AREA IN THE BARIUM TUBE SECTION APPROX 2 INCHES FROM THE HUB AREA. THE REMAINING PORTION OF THE BARIUM ABOUT 3.5 INCHES SHOWED A SLANT CUT AT THE OUTER END. A SMALL PORTION OF THE BARIUM TUBE LOCATED AT THE FRACTURE SITE IS MISSING FROM THE TUBE. THE CHARACTERISTICS OF THE FRACTURED AREA ARE SIMILAR TO THOSE CAUSED BY A NICK OR PUNCTURE WITH A SHART ONJECT. THE DRAINS RECEIVE A PULL TEST FOR A MINIMUM OF 8 POUNDS DURING THE MFG PROCESS.
AFTER THE IAB WAS INSERTED INTO THE PT, THE MEMBRANE WOULD NOT UNFOLD.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY UNFOLDED. LABORATORY EXAMINATION REVEALED NO DEFECTS IN THE RETURNED IAB. THE IAB INFLATED AND FUNCTIONED NORMALLY WHEN ATTACHED TO THE SYSTEM 90 IN THE LAB AT 80 AND 160 BPM. NO PUMP ALARMS WERE TRIGGERED. DEVICE LABEL CODE: 1738.
THE IAB WAS INSERTED ON 8/7/96 AT 9AM. AFTER 7 HRS OF IABP, THE BALLOON LEAKED. BLOOD WAS NOTED IN THE CATHETER TUBING. THE BALLOON WAS REMOVED. A SECOND IAB WAS NOT INSERTED INTO THE PT.
TO DATE THE PRODUCT HAS NOT BEEN RETURNED TO CO FOR EVALUATION. THIS FORM WAS COMPLETED BY THE MFR.
SEVERE ALLERGIC REACTION TO LATEX GLOVES, IN WHICH AIRWAYS CLOSED DOWN, MAKING PT UNABLE TO BREATHE AND REQUIRING INTUBATION. CONSUMER HAS BEEN OUT OF WORK NOW SINCE NOVEMBER. HOSP LET HER GO, AND SHE HAS BEEN UNABLE TO ACQUIRE ANOTHER RESPIRATORY THERAPY POSITION. CONSUMER MAY HAVE TO RELOCATE TO ANOTHER PART OF THE COUNTRY SO THAT SHE CAN WORK. THIS IS DIFFICULT THING TO DO AS A SINGLE PARENT.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE ANY PRODUCT IDENTIFICATION OR LOT NUMBER INFO.
DURING A LAPAROSCOPIC BURCH PROCEDURE, THE NEEDLE BROKE WHILE PASSING THROUGH COOPER'S LIGAMENT. AN X-RAY WAS PERFORMED POST-OPERATIVELY TO LOCATE THE NEEDLE. A REOPERATION WAS PERFORMED AND THE NEEDLE WAS NOT LOCATED. THE HOSP HAS REPORTED THE PT IS IN SATISFACTORY CONDITION.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738 AND POSITION 2: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 8/12/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 8/12/96.
RPTR GETS DELAYED ALLERGIC REACTION AFTER USING GLOVE. MORNING AFTER USING GLOVE, HIS HANDS BREAK OUT IN HUNDREDS OF BLISTERS. NEXT, BLISTERS START TO WEEP, SKIN CRACKS AND PEELS OFF, MAKING IT EXTREMELY PAINFUL. RPTR HAS DEVELOPED CONTACT DERMATITIS. NOW, HE REACTS TO RUBBER HANDLES, ON EXERCISE EQUIPMENT, MOUSE PADS, BOWLING BALLS, ETC. HE FEELS DISABLED BY THIS PROBLEM AND IS ANXIOUS TO FIND A SOLUTION. BECAUSE THE RAST TEST AND PRICK TEST ARE NEAGTIVE. HE THINKS HE IS TYPE IV ALLERGIC.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTED DID NOT PROVIDE ANY PRODUCT IDENTIFICATION OR LOT NUMBER INFO.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. THE PENETRATION HAS THE CHARACTERISTICS TYPICALLY PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECT TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY. DEVICE LABEL CODE: 1738.
THE IAB WAS INSERTED INTO THE PATIENT ON 8/8/96. AFTER 2 DAYS OF IABP, BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED FROM THE PATIENT ON 8/10/96.
THE IAB WAS PLACED IN THE PT IN THE OR. AFTER 6 DAYS OF IABP, THE PUMP ALARM SOUNDED. BLOOD WAS NOTED IN THE CATHETER TUBING. THE CO'S PUMP        WAS CHANGED TO ANOTHER, SAME MODEL. THE IAB WAS REMOVED AND ANOTHER BALLOON WAS INSERTED. THE PT DID HAVE A LOT OF PLAQUE.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WA FRECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. THE PENETRATION HAD THE CHARACTERISTICS TYPICALLY PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON LINER OR BIAXIAL FOLDING. BIAXIAL FOLDING PRODUCED WHEN THE BALLOON IS SUBJECT TO A NON-PREDICATABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIAMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCALVAIN ARTERY. DEVICE LABEL CODE: 1738.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. DEVICE DEVELOPED A SLOW LEAK AROUND THE TROCAR SLEEVE. A 2ND DEVICE WAS OPENED AND RUPTURED AFTER A FEW PUMPS. A THIRD DEVICE WAS OPENED AND WORKED FAIRLY WELL. SURGEON EXPRESSED CONCERN ABOUT THE EVENT AND ELECTED TO CONVERT TO AN OPEN PROCEDURE TO COMPLETE THE CASE.
SECTION F CORRECTION: ALL INFO SUPPLIED ON THE INITIAL REPORT SHOULD HAVE BEEN NA BECAUSE NO USER FACILITY MEDWATCH REPORT WAS RECEIVED. RESULTS OF EVALUATION: CONCLUSION; A) IT WAS CONCLUDED THAT THE BALLOON HAD BECOME PUNCTURED IN THE DISTAL TIP AND CUT IN THE PROXIMAL PORTION, MAKING TEH INST. NON FUNCTIONAL. THE INST. WAS RECEIVED WITH 2 CUTS IN THE BALLOON IN THE PROXIMAL PORTION. THE CUTS WERE APPROX. 135 DEGREES FROM THE STOPCOCK POSITION, AND 1/16" LENGTH AND 3/16" APART FROM ONE ANOTHER, IN LINE WITH THE EXTENSION LEG. THERE WERE ABRASION MARKS AROUND THE CUTS. A PUNCTURE HOLE WAS OBSERVED IN THE DISTAL PORTION OF THE BALLOON AND WAS 1/64" IN DIAMETER. B) IT WAS CONCLUDED THAT THE BALLOON HAD BURST NEAR THE DISTAL TIP, MAKING THE INST. NON FUNCTIONAL. THE INST. WAS RECEIVED WITH A BALLOON WHICH HAD BURST AND APPROX. 60% OF THE BALLOON WAS NOT RETURNED WITH PRODUCT. THE INST. WOULD NOT FUNCTION AS DESIGNED DUE TO A BALLOON WHICH HAD BURST. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE BALLOONS TO BURST. AB) EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
NURSE WAS PRIMING THE SET AND REPORTED FLOW WOULD NOT STOP. THE SET WAS NOT CONNECTED TO A PT.
EVALUATION OF THE SET REVEALED THE FLOW STOP BALL WAS MISSING. CHANGES TO THE INSPECTION AND TESTING PROCESS WILL BE IMPLEMENTED TO PREVENT RECURRENCE OF THE MISSING BALL.
CERAMIC TIP OF DEVICE REPORTEDLY "BROKE" DURING PROCEDURE, MAY HAVE COME IN CONTACT WITH METAL SHAVER. CASE WAS COMPLETED, CERAMIC CHIP REMOVED. NO PT CONSEQUENCE.
OPERATOR'S MANUAL CAUTIONS AGAINST DEVICE COMING INTO DIRECT CONTACT WITH OTHER METAL OBJECTS. ENGINEERING EVALUATION SHOWED FAILURE WAS MECHANICAL STRESS INDUCED BY USER/USER ENVIRONMENT.
A 23 YR OLD WOMAN HAD AN ANAPHYLACTIC RESPONSE WITHIN SECNDS ON PIC LINE INSERTED. SYMPTOMS INCLUDE HYPOTENSION, TACHYCARDIA, DIMINISHED LEVEL OF CONSCIOUSNESS. PT WAS TREATED WITH BENADRYL AND O2. (PIC REMOVED IMMEDIATELY.)
F-BLOCK: THIS REPORT NOT FROM A USER FACILITY.
THE PT UNDERWENT A RIGHT PHACOEMULSIFICATION WITH POSTERIOR CHAMBER INTRAOCULAR LENS IMPLANT. FOLLOWING THE PROCEDURE THE PT WAS SEEN BY HER OPHTHALMOLOGIST AND A DIAGNOSIS OF RETINAL BURN WAS MADE.
DEVICE HAS NOT YET BEEN RETURNED FOR EVAL.
PT RECEIVED A CORNEAL BURN OR RENT DUE TO THE SITE MACHINE.
A BALLOON RUPTURED ON THE FIRST INFLATION DURING AN AV FISTULA DILATATION PROCEDURE. IT IS UNK HOW MANY ATMOSPHERES WERE ACHIEVED PRIOR TO THE BALLOON RUPTURE, AND CO'S ATTEMPTS TO GAIN FURTHER INFO HAVE BEEN UNSUCCESSFUL. THERE WERE NO PT COMPLICATIONS. THIS PRODUCT HAS BEEN DESTROYED BY THE USER FACILITY, THEREFORE NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURES OF EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATIONS. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
THE IAB WAS INSERTED INTO THE PT ON 7/30/96. AFTER IAB FOR APPROX 30 HRS AT 10 PM ON 7/31/96, THE "SLOW GAS" ALARM SOUNDED. THE TROUBLE SHOOTING PROCEDURE WAS FOLLOWED. ALL THE CONNECTIONS WERE CHECKED. THE CATHETER EXTENDER TUBING WAS INSPECTED AND THE BALLOON WAS REFILLED. THERE WERE NO FURTHER ALARMS UNTIL THE MIDNIGHT SHIFT. TROUBLE SHOOTING WAS AGAIN PERFORMED. THE BALLOON THEN APPEARED TO BE PUMPING APPROPRIATELY. THERE WERE NO FURTHER ALARMS. WHEN THE CATHETER WAS REMOVED ON 8/1/96, BLOOD WAS NOTED IN THE EXTENDER TUBING.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PORDUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHING A WHITSISH PATCH. THE PTACH, WHEN STAINED, EXHIBTED THE TYPICAL APPEARANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. DEVICE LABELLING CODE: 1738.
B6 COMPONENT, DRIVE NUT ASSY, AND ENVIROMENTAL.
CATHETER WAS DISCOVERED TO BE BROKEN WHEN SURGEON WENT IN TO REPLACE IT. A PIECE THAT WAS BROKEN OFF WAS REMOVED AND SENT TO CO-OTHER PIECE UNABLE TO REMOVE. CATHETER WAS POSITIONED IN LEFT SUBCLAVIAN.
ACCOUNT REPORTS SEVERAL INCIDENTS, SINCE INTRODUCTION OF DEVICE, IN WHICH MALE ADAPTER DISCONNECTS FROM CATHETERS IN THE NICU AND PICU. DEVICE USED ON CENTRAL, PERIPHERAL AND ARTERIAL LINES. KNOWN PT INJURIES OR LINE REPLACEMENTS REQUIRED BUT ACCOUNT STATES, "LOTS OF BLEEDING-THEY CALLED THEM BLOOD BATHS."
SECTION F COMPELTED BY CO. NO OTHER INFO IS AVAILABLE. EVALUATION: THE SAFE AND EFFICACIOUS USE OF LUER SLIP ADAPTERS IS DEPENDENT ON A COMBINATION OF SPECIFIC MECHANICAL FORCES EMPLOYED DURING CLINICAL CONNECTION. ADEQUATE INSERTION FORCE APPROACHING AN OPTIMAL FIVE AXIAL POUNDS IN SIMULTANOUS COMBINATION WITH A SLIGHT ROTATIONAL TWIST, 30 TO 45 DEGREES, OF THE ADAPTER IS RECOMMENDED IN ORDER TO ACHIEVE A STABLE AND LEAK FREE CONNECTION. IN ADDITION, THE USE OF A LUER LOCK DEVICE CONTINUES TO BE RECOMMENDED FOR CONNECTIONS TO CENTRAL AND ARTERIAL LINES OR IN CLINICAL APPLICATIONS REQUIRING A LOCKING MECHANISM DUE TO INERTIAL FORCES OR SIDE LOADS.
THE IAB WAS INSERTED ON 8/8/96. AFTER 7 HRS OF IABP ON 8/9/96, BLOOD WAS NOTED IN THE CATHETER TUBING.
THIS FROM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FROM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDEREATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SENN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE  WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. DEVICE LABEL CODE: 1738.
THE PHYSICIAN WAS ABOUT TO UTILIZE THE DEVICE KIT AND NOTED THAT THE SYRINGES CONTAINED IN THE DEVICE KIT WERE DISCOLORED. THE PHYSICIAN USED ANOTHER DEVICE KIT TO COMPLETE THE DEVICE IMPLANT SURGERY.
DEVICES WERE RETURNED TO MFR AND VISUAL EXAMINATION CONFIRMED REPORT OF YELLOW DISCOLORATION. SEVERAL LOTS OF DEVICE WERE SENT TO AN OUTSIDE FACILITY FOR FURTHER ANALYSIS AND HAVE BEEN ANALYZED AS FOLLOWS: DEVICES WERE MOLDED FROM TRANSLUCENT POLYPROPYLENE AND KITS CONTAINING DEVICES WERE ETHYLENE OXIDE STERILIZED. EXAMINATION OF DEVICES REVEALED MORE INTENSE YELLOW COLORATION EXISTING AT LUER END OF DEVICES. EXAMINATION  OF LONGITUDINAL CUT SECTION FO DEVICE BARRELS INDICATED THAT YELLOW COLORATION WAS CONSISTENT FROM INSIDE TO OUTSIDE OF DEVICE BARRELS. PLUNGER OF ALL DEVICES EXAMINED WAS NORMAL IN COLOR. YELLOW COLORATION GRADUALLY TRANSITIONED TO WHITE TRANSLUCENT NORMAL COLORATION OF POLYPROPLENE AT FLANGE END OF DEVICE. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDETNS FOR THIS CATALOG/LOT NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT. BASED ON REVIEW AND EXAMINATION OF THESE RETURNED DEVICES, YELLOW COLORATION WAS DETERMINED TO BE MOLDING INDUCED. EXAMINING FACILITY FOUND THAT "MOST PROBABLY" SECTION OF TOOL USED TO FORM DEVICE FROM MOLTEN PLASTIC WAS IN AN OVERHEATED CONDITION. PLASTIC IN CONTACT WITH THIS LUER SECTION OF MOLD OVERHEATED AND DEGRADED. POLYPROPYLENE WHEN SLIGHTLY DEGRADED, CHANGES FROM WHITE TRANSLUCENT TO YELLOE. BY HEATING A DEVICE, IT HAS BEEN CONFIRMED THAT HEAT CAUSES A COLOR CHANGE TO YELLOW IN DEVICE. PHYSICAL PROPERTIES OF DEVICE WERE CONSISTENT WITH NORMAL APPEARING DEVICES. ADDITIONALLY, DEVICES WERE NEGATIVE TO CELL TOXICITY. THEREFORE, BASEON ON INFO AVAILABLE AND RESULTS OF DEVICE ANALYSIS, REPORT OF YELLOW DISCOLORATION OF DEVICES HAS BEEN CONFIRMED; HOWEVER, YELLOW DISCOLORATION IS COSMETIC ONLY AND DOES NOT AFFECT FUNCTION OR SAFETY OF DEVICES. CUSTOMER WILL BE NOTIFIED OF MFR'S FINDINGS. NO FURTHER DETAILS ARE AVAILABLE.
THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER. THE DR HAD DIFFICULTY REMOVING THE IAB AND PULLED THE CATHETER OUT BY FORCE.
F BLOCK: INFO SUPPLIED BY MFR TO THE BEST OF CO'S KNOWLEDGE.
THERE WAS NO BLUE RECORD SHEET IN THE USER CARTON. THE IAB WAS USED WITHOUT A PROBLEM.
SINCE THE PRODUCT INVOLVED IN THIS EVENT WAS NOT RETURNED OR RELEASED TO CO FOR EVALUATION, NO ADD'L INFO CAN BE PROVIDED AND THE FILE WILL BE CLOSED. THE IAB WAS USED WITHOUT A PROBLEM.
THE DEVICE WAS USED DURING A LAPAROSCOPIC SPLENECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT COULD NOT BE FIRED THE SECOND TIME. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE IAB WAS INSERTED INTO THE PT ON 7/7/96. AT 1900 THAT EVENING, THE IAB LEAKED AND THE IAB WAS REMOVED. A SECOND WAS NOT INSERTED AND THE PT IS DOING WELL.
DURING A LOBECTOMY PROCEDURE, THE DEVICE WOULD NOT RELEASE FROM TISSUE FOLLOWING FIRING. THE SURGEON RESECTED THE DEVICE WITH A MINIMAL AMOUNT OF ADD'L TISSUE. THE HOSP HAS REPORTED THE PT IS IN SATISFACTRY CONDITION.
THE CLINICALLY APPLIED DEVICE WAS EVALUATED AT CO'S FACILITY. UPON EXAMINATION IT WAS FOUND THAT THE JAWS OF THE STAPLER WOULD NOT OPEN PROPERLY. CO HAS CONCLUDED THAT THIS CONDITION WAS THE RESULT OF THE USER PLACING AN EXCESSIVE AMOUNT OF TISSUE IN THE JAW OF THE INSTRUMETN. SPECIFICALLY. THE TISSUE WAS IN AND AROUND THE ALIGNMENT PIN HOLE AND METAL JAW COMPONENTS. THE TISSUE IN THESE AREAS CAUSED INTERFERENCE AND PREVENTED TEH JAWS FROM READILY RELEASING. WITH THE TISSUE IN QUESTION REMOVED, THE JAWS OPENED AND CLOSED WITHOUT DIFFICULTY. THE DEVICE WAS RELOADED WITH STAPLES AND TEST FIRED AT FACILITY AND NO ABNORMALITIES WERE OBSERVED. CO HAS CONCLUDED THAT THE DIFFICULTY EXPERIENCED WAS THE RESULT OF THE USER FAILING TO USE THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE WHICH ACCOMPANY EACH DEVICE SHIPMENT.
DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION THE SURGEON WAS USING THE LCS. THE ENTIRE DISSECTION WHICH PROGRESSED UNEVENTFULLY. THE SURGEON THEN DISSECTED THE SHORT GASTRIC ON POWER LEVEL 2 WITH THE FLAT BLADE. WITHIN 1 SECOND, THE VESSEL BLEW OPEN. ATTEMPTS WERE MADE TO CONTROL BLEEDING FOR 5 MINS USING CLIPS. THE BLEEDING WAS UNABLE TO BE CONTROLLED AND THE CASE WAS CONVERTED TO OPEN. TIED OFF VESSEL WITH CLIPS. CASE THEN COMPLETED. PT EXPERIENCED APPROX 300 CC BLOOD LOSS BUT REQUIRED NO BLOOD TRANSFUSION. PT DOING WELL AT THIS TIME.
DEVICE NOT RECEIVED YET. INFO NOT KNOWN. ON 8/23/96, RISK MGMT HAD NO INFO AT THIS TIME. ON 8/26/96, RISK MGMT CALLED BACK AGAIN AND ASKED WHAT INFO CO NEEDED. THEY STATED THEY WILL ATTEMPT TO LOCATE THE INFO AND RETURN CALL.
THE GASTROSTOMY TUBE BECAME DISLODGED. THE PT WAS RETURNED TO SURGERY FOR EXPLORATORY LAPAROSCOPY, LAVAGE AND RE-INSERTION OF FEEDING TUBE. THE BALLOON WAS FOUND TO BE DEFLATED WITH APPARENT LEAK.
DURING A LAPAROSCOPIC ASSISTED HYSTERECTOMY, THREE SUTURE NEEDLES BROKE WHEN THE SUTURE WAS USED IN SUTURING THE PEDICLE. TWO BROKEN NEEDLE TIPS WERE RETRIEVED WITHOUT THE USE OF X-RAY; ONE WAS RETRIEVED WITH X-RAY SEARCH. THERE WAS NO SIGNIFICANT DELAY OF THE PROCEDURE AND NO INJURY TO THE PT.
ONE BROKEN NEEDLE WAS RETURNED FOR EVALUATION. THE NEEDLE WAS INSPECTED UNDER 20X MAGNIFICATION AND REVEALED SHARP INSTRUMENT MARKS THROUGHOUT THE NEEDLE SURFACE. SAMPLES FROM THIS LOT WERE TESTED FOR BRITTLENESS AND STRENGTH. HALF WERE MANUALLY BENT AND DISPLAYED NO BREAKAGE. TINIUS OLSEN STRENGTH TESTING WAS SATISFACTORY. LOT HISTORY RECORD WAS SATISFACTORY. BASED ON THE CONDITION OF THE RETURNED NEEDLE FRAGMENT, USER HANDLING MAY HAVE CONTRIBUTED TO THE BREAKAGE REPORTED.
THE DEVICE WAS USED DURING AN ILEO-CECAL ANASTOMOSIS. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED MANUAL SUTURE. THE  HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
OR AXLE MAG W/NUT DEALER CLAIMS HE JUST RECEIVED AND IT HAS NO BALL BEARINGS IN IT.
DURING AN UPPER ENDOSCOPY PROCEDURE, THE TIP OF THE HEATER PROBE DISCONNECTED AND FELL INTO THE PT'S STOMACH. ALTHOUGH THE MD WAS UNABLE TO RETRIEVE THE TIP, THERE WERE NO PT INJURIES AND DURING A FOLLOW UP EXAM FOR AN UNRELATED REASON, AN X-RAY WAS TAKEN AND IT WAS NOTED THAT THE PIECE HAD PASSED. THE HOSP DECIDED NOT TO SEND THE HEATER PROBE FOR EVALUATION.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY, A SUTURE NEEDLE DETACHED FROM SUTURE WHEN THE UMBILICAL PORT WAS SUTURED. THE NEEDLE WAS RETRIEVED FROM THE TISSUE BETWEEN THE SKIN AND THE PERITONEUM WITHOUT THE USE OF X-RAY. THERE WAS NO SIGNIFICANT DELAY OF THE PROCEDURE AND NO INJURY TO THE PT.
ONE SAMPLE WAS RETURNED FOR EVALUATION. THE NEEDLE WAS FOUND TO BE DETACHED AS RECEIVED. MICROSCOPIC EVALUATION OF THE RETURNED SAMPLE AT 20X-80X MAGNIFICATION INDICATED THAT SUTURE FILAMENTS HAD BEEN SEVERELY DAMAGED BY INSTRUMENTAL HANDLING. THE LOCATION OF THIS DAMAGE WAS ADJACENT TO THE NEEDLE SURTURE JUNCTURE. THE RESULTS INDICATE THAT INSTRUMENTAL MANEUVERING HAD BEEN APPLIED TO THE SUTURE LINE NEAR THE SUTURE NEEDLE JUNCTURE, WHICH RESULTED IN PULLING THE SUTURE LINE OUT OF THE DRILLED HOLE IN THE NEEDLE, I.E. NEEDLE DETACHMENT. FURTHER INVESTIGATION WAS NOT POSSIBLE AS NO UNUSED SAMPLES WERE AVAILABLE AND NO LOT NUMBER INFORMATION WAS SUPPLIED.
THE DEVICE WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON APPLIED ANOTHER DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PT CLAIMED BLISTERS DEVELOPED ON HER KNEE AND BEHIND KNEE. MACHINE FELT DIFFERENT THAN FIRST DAY. UNIT WAS EXCHANGED IMMEDIATELY. HOME HEALTH AID APPLIED TO BLISTERS. DR CALLED AND ADVISED PT TO STOP USING UNIT. UNIT WAS IMMEDIATELY EXCHANGED.
WHILE PERFORMING A RIGHT THORACOSCOPIC LUNG RESECTION, DR HAD A PROBLEM WITH STAPLE FORMATION. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PT DROPPED HAND CONTROLLER. UNIT WAS SET AT 55 DEGREES AND ALLEGEDLY WENT UP TO 90 DEGREES WITH PT'S LEG ON IT. IN DR'S NOTE HE WROTE THAT PT DROPPED THE HAND CONTROLLER AND PT REPORTED ACUTE FLEXION EPISODE. PT CLAIMS KNEE ALMOST WENT TO THE CHEST. SUPERFICIAL WOUND DRAINAGE NOTED THIS MORNING WHEN DRESSING WAS CHECKED. TAPE WAS ACCROSS SUTURE LINE. PT NOTED TO HAVE ELEVATED LEG WITH PILLOWS.
THE DEVICE WAS USED DURING AN APPENDECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT CLOSE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. THE SURGEON USED ANOTHER INSTRUMENT.
THE DEVICE WAS USED ON AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE CLIPS DID NOT CLOSE PROPERLY, THE DR USED ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED ON THE LARGE SIGMOID. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON USED A NEW INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. DEVICE EXP DATE: 5/31/2001.
THE PUMP DID NOT FILL WITH HELIUM DURING THE PURGE CYCLE. THE PT WAS  TRANSFERRED TO ANOTHER INTRAAORTIC BALLOON PUMP WITHOUT INCIDENT. THERE WERE NO PT COMPLICATIONS INVOLVED.
2423-NOT LABELED. DEVICE NOT EVALUATED BY CO, HOWEVER THE BIO-MED DEPARTMENT AT THE USER FACILITY EVALUATED AND REPAIRED THE BALLOON PUMP. THE BIO-MED DEPARTMENT AT THE USER FACILITY EVALUATED THE BALLOON PUMP. THE ONE WAY CHECK VALVE LOCATED INSIDE OF THE DOME ASSEMBLY WAS OBSTRUCTED. THE HOSE KIT AND HELIUM VALVE WERE REPLACED AND THE PUMP WAS PLACED BACK INTO SERVICE.
LEFT IMPLANT RUPTURED DURING REMOVAL. CAPSULAR CONTRACTURE BG III.
PT ADMITTED TO HOSP FOR ONE DAY STAY TO HAVE ICD LEAD REMOVED BECAUSE OF INAPPROPRIATE SHOCKS. LEAD EXPLANTED 8/5/96. LEAD IMPLANTED 12/23/92.
WITHIN A NON CALCIFIED LESION, THE BALLOON BURST.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED AN AXIALLY-DIRECTED TEAR. MICROSCOPIC EXAMINATION: LIGHT OPTICAL EXAMINATION ON THE INNER BODY AND MARKER BANDS REVEALED NO ANOMALIES. FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED NO EVIDENCE OF INTERNAL SURFACE ABRASIONS OR OTHER ANOMALIES. THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED.
AN INTRA-AORTIC BALLOON PUMP WOULD NOT OPERATE DURING TRANSPORT. THE PT WAS TRANSFERRED TO ANOTHER INTRA-AORTIC BALLOON PUMP AND TRANSPORT OF THE PT OCCURRED WITHOUT FURTHER INCIDENT. THERE WERE NO PT COMPLICATIONS INVOLVED.
TE BIO-MED DEPARTMENT AT THE USER FACILITY EVALUATED THE BALLOON PUMP. AN INTERMITTENT CONNECTION FROM THE HARNESS ASSEMBLY TO THE BATTERY ASSEMBLY WAS NOTED. THE HARNESS ASSEMBLY WAS REPLACED AND THE BALLOON PUMP WAS PLACED BACK INTO SERVICE. CO ROUTINE MAINTENANCE SCHDULE ADDRESSES THIS ISSUE AND STATES TO CHECK ALL WIRE CONNECTIONS. CO BELIEVES APPROPIATE MAINTENANCE OF THIS DEVICE COULD HAVE PREVENTED THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE. 1371-NOT LABLED. EVALUATED AT THE USER FACILITY BY HOSP BIO-MED DEPARTMENT.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS A FALSELY HIGH TEST RESULT. THERE IS A POSSIBILITY THAT THIS MALFUNCTION UNDER CERTAIN CONDITIONS WERE IT TO RECUR, COULD RESULT IN ADVERSE CLINICAL EFFECTS TO THE USER OF THE SYSTEM.
RETAIN TESTING OF BATCH #60833 INDICATES THAT THE CLINICAL EFFICACY OF THE BATCH IS ACCEPTABLE.
COMPLAINT INVESTIGATION CONFIRMS TEST RESULTS OUT-OF-RANGE WITH CONTROL SOLUTION (SPECIFIC FOR VERIFYING DEVICE PERFORMANCE). ANALYSIS INDICATES THAT THESE RESULTS, HAD THEY BEEN OBTAINED FROM A PT SAMPLE, COULD POTENTIALLY HAVE ADVERSE CLINICAL EFFECTS.
CONTROL SOLUTION RESULTS WERE OUT OF RANGE FOR THE USER OF THE SYSTEM BUT NO PRODUCT MALFUNCTION COULD BE IDENTIFIED. THERE WAS NO IMPACT TO THE USER.
PT PRESENTED WITH POOR PACING CAPTURE THRESHOLDS AND ELEVATED PACING IMPEDANCE. VENTRICULAR PACING LEAD WAS EXTRACTED AND REPLACED. IMPLANTED 3/9/93.
THE ACCESS CATHETER INCLUDED IN THIS STENT KIT BROKE UPON REMOVAL AT THE COMPLETION OF AN EXTRACORPOREAL RETROGRADE ENDOSCOPIC CHOLANGIOPANCREATOGRAPHY PROCEDURE LEAVING A PORTION IN THE PT'S URETER. RETRIEVAL OF THE DETACHED SEGMENT UTILIZING GRASPERS WAS UNEVENTFUL AND THE PT'S CONDITION IS GOOD. THE PT'S CALCULI AND/OR THE PROCEDURE MAY HAVE BEEN CONTRIBUTING FACTORS TO THIS EVENT, HOWEVER, UNTIL COMPLETION OF THE EVALUATION OF THIS DEVICE CO CANNOT DETERMINE THE CAUSE OF THIS EVENT.
THE ACCESS CATHETER FROM THE STENT KIT WAS RECEIVED, EVALUATED AND RETAINED BY THE MFR. THE DEVICE WAS RECEIVED IN TWO SEPARATE PIECES, WITH THE DISTAL SEGMENT MEASURING 17CM LONG. THE EXTRUSION AT THE POINT OF BREAKAGE WAS ELONGATED AND TWISTED AND APPEARED TO HAVE PUNCTURED. NO INDICATIONS OF EXTRUSION DEGRADATION WERE FOUND. ALL OTHER ASPECTS OF THE DEVICE WERE FOUND. ALL OTHER SAPECTS OF THE DEVICE WERE FOUND TO BE WITHIN SPECIFICATION. CO'S ENGINEERING EVALUATION INDICATEDF THE POINT OF BREAK WAS ENLOGATED AND STRETCHED, INDICATING EXCESSIVE FORCE MAY HAVE BEEN APPLIED UPON REMOVAL. CO BELIEVES USER TECHNIQUE AND/OR PT ANATOMY RATHER THAN A PRODUCT PROBLEM CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE.
THE BALLOON BURST AT AN INITIAL INFLATION OF 8 ATMOSPHERES.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED AN AXIALLY-DIRECTED TEAR. MICROSCOPIC EXAMINATION: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS ADJACENT AND INTERSECTING THE TEAR EDGE. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON TEAR COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED NO VISUAL ANOMALIES. FUNCTIONAL TESTING: THE BALLOON WAS INFLATED WITH 3CC AIR, WHICH WAS SUBMERGED IN WATER; NO AIR BUBBLES WERE NOTED. THE BALLOON WAS PRESSURIZED WITH WATER, USING AN INDEFLATOR TO THE RATED PRESSURE OF 10 ATMOSPHERES, FOR FOUR HOURS; NO PRESSURE DROP OR LEAKAGE WERE NOTED. THE EXACT CAUSE FOR THE REPORTED DIFFICULTY DURING CLINICAL USE COULD NOT BE DETERMINED.
IAB CATHETER WAS INSERTED IN THE MORNING AND WAS REMOVED AT 1900 THAT EVENING DUE TO BALLOON RUPTURE. REPLACEMENT WAS NOT DONE, PT IS DOING FINE.
WHILE UNDERGOING AN ORAL SURGERY PROCEDURE, THE PT SUSTAINED A BURN TO THE MIDPORTION OF THE UPPER LIP. A CO DISPOSABLE 6" BLADE ELECTRODE WAS INSERTED INTO ANOTHER CO'S HANDSWITCHING PENCIL CONNECTED TO ANOTHER CO'S SOLID STATE ELECTROCAUTERY UNIT USED FOR THE PROCEDURE. BIOMEDICAL ENGINEERING CHECKED THE EQUIPMENT AND COULD NOT IDENTIFY A PROBLEM OR DUPLICATE THE SITUATION WHERE A BURN COULD OCCUR.
THE DEVICE IN QUESTION WAS DISCARDED BY THE USER FACILITY AND WAS NOT AVAILABLE FOR EVALUATION BY THE MFR. A SAMPLE ITEM WAS TESTED AND NO RESULTS COULD BE ACHIEVED. CONVERSATIONS WITH THE USER FACILITY INDICATED A BELIEF THAT THE GROUND CONTACT WAS NOT SUFFICIENT. TESTING OF ALL THE DEVICES INVOLVED WAS DONE BY THE FACILITIES ANALYSIS TEAM. NO DEVIATIONS OR PRODUT MALFUNCTIONS COULD BE RECREATED. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? U. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS SEVERITY OF THIS EVENT GREATER THAN LABELED? N.
A FILTER DID NOT OPEN AFTER DEPLOYMENT. A SECOND FILTER WAS SUCCESSFULLY PLACED WITH NO PT COMPLICATIONS. A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO FILTER PLACEMENT AND CONTINUAL FLUSHING OF THE CARRIER SYSTEM DURING THE IMPLANT PROCEDURE WAS NOT PERFORMED WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT. "AN INFERIOR VENA CAVOGRAM MUST BE PERFORMED PRIOR TO VENA CAVA FILTER INSERTION. THIS PROCEDURE DETERMINED CAVAL PATENCY AND DIAMETER AND IS USED TO EVALUATE THE INFERIOR VENA CAVA FOR THE PRESENCE OF THROMBUS AND CONGENITAL ANOMALIES. DO NOT ATTEMPT TO MOVE OR MANIUPLATE AN ENGAGED FILTER. IN MOST CASES, A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE. THE INTRODUCER CATHETER MUST BE FLUSHED THROUGH THE FLUSH PORT BY FREQUENT INJECTION OR CONTINUOUS INFUSION OF STERILE HEPARINIZED SALINE DURING THE IMPLANT PROCEDURE. INSUFFICIENT FLUSHING CAN ALLOW THROMBUS FORMATION INSIDE THE VENA CAVA FILTER WHICH CAN BIND LEGS AND PREVENT COMPLETE OPENING UPON RELEASE."
THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE FILTER WAS NOT RETURNED WITH THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS RETURNED IN THE RELEASED POSITION. ALL OTHER ASPECTS OF THE UNIT WERE WITHIN REQUIRED SPECIFICATIONS. SINCE THE  FILTER REMAINED IMPLANTED A THOROUGH EVAL COULD NOT BE PERFORMED. OTHER/ENTIRE DEVICE WAS NOT RETURNED, THEREFORE UNABLE TO PERFORM COMPLETE EVAL.
SYSTEM STALLED AND BECAME STUCK IN THE LESION LOCATION. THE LESION WAS VERY CALCIFIED AND ANGULATED. AFTER THE SYSTEM WAS PULLED OUT OF THE PT, IT WAS NOTICED THAT THE BURR WAS DETACHED FROM THE DRIVESHAFT.
VISUAL INSPECTION CONFIRMED THE ANNULUS OF THE BURR WAS FLARED. INVESTIGATION CONFIRMED THAT THE DRIVE SHAFT HAD FRACTURED PROXIMAL TO INSERTION INTO THE BURR. THE CONDITION OF THE FRACTURE SURFACES WAS CONSISTENT WITH REPEATED CYCLIC LOADING OF THE DRIVE SHAFT PRIOR TO FRACTURE. THESE FINDINGS ARE CONSISTENT WITH OPERATION OF THE ADVANCER OVER A TIGHT BEND IN THE GUIDE WIRE. VISUAL INSPECTION OF THE GUIDE WIRE CONFIRMED THE PRESENCE OF WEAR, ALSO CONSISTENT WITH OPERATION OF THE ADVANCER OVER A TIGHT BEND.
THE PLUG BURNED AND ONE PLUG PRONG IS BROKEN. THE UNIT HAS NOT BEEN RETURNED TO CO FOR INSPECTION AND MAY NOT BE. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS FREQUENCY OF THIS EVENT GREATER THAN LABELLED? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS SEVERITY OF THIS EVENT GREATER THAN LABELED? N.
DIFFERENCES IN THE USER FACILITY AND MFR OF THE DEVICE REPORTS: THE USER FACILITY REPORTED PT CODE, FRAGMENTS OF DEVICE REMAIN IN PT, AND DEVICE CODE, OTHER. THE MFR OF THE DEVICE AGREES THAT CODE IS APPROPRIATE AS A DEVICE CODE, AND BELIEVES THAT CODE IS UNNECESSARY.
51 YEAR OLD MALE UNDEWENT A ROTABLATOR PROCEDURE, UPON REMOVAL OF THE WIRE, THE DISTAL PORTION (APPROX 1 INCH) WAS NOTED TO BE MISSING. THIS PORTION OF THE C WIRE WAS RETAINED IN THE DISTAL ANTEROLATERAL BRANCH OF THE CORONARY ARTERY. THE PLAN WAS TO TREAT MEDICALLY WITH TICLID AND ASA. PT WAS AMBULATORY IN THE HALLS AND WAS DISCHARGED THE FOLLOWING DAY.
ON 7/16/96 PT HAD 10MM DRAIN PLACED IN PELVIS AND OUT THROUGH STAB WOUND. ON 7/18/96 THIS DRAIN WAS ORDERED REMOVED. WHEN GENTLE FORCE PLACED ON THE PROXIMAL DRAIN, IT APPEARS TO HAVE FRACTURED FROM DISTAL END. PT RETURNED TO SURGERY ON 7/19/96 FOR REMOVAL.
THE SWITCH EMITTED SPARKS. CO'S INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROX. 1967 TO 6/21/90, CO USED AN UNDERWRITER'S LABORATORIES LISTED SWITCH MFG BY A REPUTABLE FIRM. THE SWITCH WAS A MOMENTARY TYPE SWITCH WITH A SPRING LOADED LEVER WHICH REQUIRED BEING HELD IN THE "ON" POSITION TO MAKE CONTACT. SOMETIMES A USER WOULD NOT FULLY ENGAGE THE LEVER, ALLOWING THE CONTACTS TO REMAIN SLIGHTLY OPEN WHICH COULD INDUCE ARCING. WHEN CONSISTENTLY HELD IN THIS WAY. CARBON BUILD-UP FROM THE ARCING COULD REACH OPPOSITE POLES CAUSING THE SWITCH TO EMIT A SMALL AMOUNT OF SMOKE. CO'S FIRST SOLUTION WAS TO CHANGE THE CONTACT MATERIAL AND THE BODY OF THE SWITCH. THIS REDUCED THE ARCING OF THE CONTACTS AND THE CARBON TRACKING OF THE SWITCH BODY. ALTHOUGH THE SITUATION WAS IMPROVED, THE OCCASIONAL RELEASE OF A PUFF OF SMOKE WAS POSSIBLE. ON 6/21/90, CO BEGAN USING A SNAP ACTION SWITCH WHICH DOES NOT ALLOW THE CONTACTS TO BE HELD IN A SLIGHTLY OPEN POSITION. THIS EVENT IS NOT REPORTABLE UNDER 21CFR803 BECAUSE SIMILAR EVENTS WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE RO BE COMPLIANT WQITH REGULATORY LETTER 90-DT-12. REMEDIAL ACTION HAS BEEN ACCOMPLISHED.
IS FREQUENCY OF OCCURRENCE OF THIS EVEN ADDRESSED IN THE DEVICE LABELING? Y. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LEBELLING? Y. IS SEVERITY OF THIS EVENT GREATER THAN LABELED? N.
ICD SYSTEM EXPLANTED DUE TO ICD BEING AT END OF LIFE - 2 MONTHS AFTER IMPLANT. IMPLANTED 5/8/96.
ON 8/14/96 HOSP REPORTED THAT THE SAMPLE WILL BE RETAINED BY THE HOSP FOR POSSIBLE LEGAL ACTION. PAST HISTORY OF COMPLAINTS OF THIS TYPE HAVE BEEN DUE TO NICKING, SUTURING AND TISSUE INGROWTH.
DEVICE WAS REMOVED FROM THE PT DUE TO LACK OF ELASTICITY-WOULDN'T PUMP RIGHT AND REPLACED.
PT HAD AORTIC VALVE IMPLANTED 4/23/93. PROGRESSED WELL UNTIL APPROX 6-12 MONTHS PRIOR TO EXPLANT (5/1/96). HEART CATH (4/30/96) - REVEALED AORTIC REGURGITATION AND AORTIC STENOSIS. AT TIME OF SURGERY (5/1/96) IT WAS NOTED - "A VERY LARGE PARAVALVULAR LEAK BETWEEN THE NON CORONARY CUSP AND THE ROOF OF THE LEFT ATRIUM BY THE LEFT CORONARY ARTERY OSTIA." THERE WAS SEVERE FIBROSIS AND PANNUS AROUND THIS AREA AND AROUND THE ENTIRE ANNULUS. THE SUTURES IN THE OLD VALVE WERE WITHOUT PLEDGETS. PT UNDERWENT STERNAL REVISION DUE TO KELOID FORMATION (7/23/96). NO PROBLEMS NOTED WITH VALVE. SAFETY OFFICE MADE AWARE OF THIS ABOVE A WEEK AFTER THE STERNAL REVISION. PT HAD TWO DIFFERENT CV SURGEONS FOR THE TWO PROCEDURES.
DEVICE WAS REMOVED FROM THE PT DUE TO INADEQUATE RIGIDITY. ANOTHER DEVICE WAS IMPLANTED.
PT ADMITTED TO ONE-DAY SURGERY TO HAVE REMOVAL OF SILICONE IMPLANTS AND INSERTION OF SALINE IMPLANTS, BILATERALLY, DUE TO LEAKING INTERNALLY INTO THE BREAST TISSUE.
PT HAD DRAIN PLACED IN FLANK AREA, THE PHYSICIAN ATTEMPTED TO REMOVE THE DRAIN WHEN IT FRACTURED OFF LEAVING A PORTION IN THE PT. THE PT WAS TAKEN TO SURGERY FOR SUCCESSFUL REMOVAL OF THE PORTION OF DRAIN FROM FLANK AREA.
EVALUATION SUMMARY: VISUAL EXAMINATION OF THE PRODUCT SAMPLE RECEIVED REVEALED A PIECE OF BARIUM TUBE OF APPROXIMATELY 5.5 INCHES, THE DRAIN HAD FRACTURED IN THE SILICONE TUBE AT THE JUNTION AREA. MICROSCOPIC EXAMINATION REVEALED A TEAR AND JAGGED EDGES AT THE FRACTURE SITE WHICH INDICATED THAT THE DRAIN HAD BEEN NICKED OR PUNCTURED BY A SHARP OBJECT UPON INSERTION OR REMOVAL. THE MINIMUM TENSILE TEST DATA OBSERVED DURING THE MANUFACTURING PROCESS OF THE LOT WAS 14.5 POUNDS. THE MINIMUM TENSILE STRENGTH SPECIFICATIONS FOR THIS DRAIN IS 750 PSI.
DEVICE WAS REMOVED FROM THE PT DUE TO RECURRENT PENILE EXCORIATION AND ULCERATION. A MALLEABLE DEVICE WAS IMPLANTED.
A NEW TYPE OF IONTOPHORESIS GROUNDER PATCH WAS SET UP USING 1CC OF DEXAMETHASONE, .25CC EPINEPHRINE, AND 1CC LIDOCAINE IN THE ELECTRODES USED TO TRANSFER THE MEDICATIONS. A NEW TRIAL PAD WAS PLACED ON THE PT'S UPPER ARM AND THE "+" CHARGE STARTED. PT TOLERATED CURRENT 4.00 WHEN THE "-" DOSE WAS STARTED AND REACHED .51. PT COMPLAINED IT WAS BURNING HER ARM. TREATMENT IMMEDIATELY STOPPED. PT RECEIVED FIRST DEGREE BURN WHERE PATCH WAS ATTACHED. AFFECTED AREA ICED - EXAMINED IN ER. SYMPTOMS GONE BY THE END OF DAY.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AND REPLACED.
THE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION AND INFECTION.
PUMP PERFORMED WITHIN SPECS. CUFF PERFORMED WITHIN SPECS. BALLOON PERFORMED WITHIN SPECS.
PT WAS SENT TO OR FOR COLON RESECTION. DURING SURGICAL PROCEDURE SURGEON NOTED RELOAD FOR THE DEVICE FIRED AND CUT BUT DID NOT DISCHARGE STAPLE LINE.
DEVICE WAS AREMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
AN ENGINEERING INVESTIGATION WAS INITIATED ON FIELD REPORTS OF AN INTERMITTENT INTERRUPTION OF THE DEFIBRILLATOR CHARGE CYCLE AND/OR LOSS OF DISPLAYED ECG INFORMATION WHEN A 3-LEAD ECG/SYNC MODULE IS INSTALLED. NONE OF THE REPORTED EVENTS WERE PT RELATED.
THE INVESTIGATION HAS DETERMINED THE ROOT CAUSE TO BE EXCESSIVE NOISE ON A POWER SUPPLY LINE IN THE MODULE. THIS NOISE IS TRANSMITTED TO THE DEFIBRILLATOR RESULTING IN AN INTERMITTENT DISRUPTION OF OPERATION. CORRECTIVE ACTION WILL BE PERFORMED ON ALL MODULES. THE SEATTLE DISTRICT OFFICE OF THE FDA WILL BE NOTIFIED. CO DOES NOT INTEND TO PROVIDE ADDITIONAL INFO ON THIS EVENT TO FDA.
NO COMPONENTS WERE REMOVED FROM THE PATIENT OR REPLACED.
ADDITIONAL INFORMATION RECEIVED ON 11/25/96 INDICATES THAT FLUID WAS ADDED TO THE DEVICE ON 11/22/96. NO COMPONENTS WERE REMOVED FROM THE PATIENT OR REPLACED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A FATIGUE AND WEAR LEAK.
SUSPECTED ESOPHAGEAL PERFORATION. PT HAD LAPAROSCOPIC TOUPET FUNDOPLICATION WITH NG PLACEMENT AND ESOPHAGEAL DIALATOR USED INTRA-OPERATIVELY.
THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
STATUS POST RADICAL PROSTATECTOMY ON 8/20/96. ORDER RECEIVED TO DISCONTINUE DRAIN ON 8/22/96. APPROPRIATE PROCEDURE FOLLOWED: SUTURE CUT, SUCTION OFF BULB. ATTEMPTS TO PULL DRAIN MET WITH RESISTANCE. DRAIN TUBING BROKE LEAVING WHITE PLASTIC IN PT'S ABDOMEN. RETURNED TO SURGERY FOR REMOVAL OF RETAINED FRAGMENT. EXTENDED LENGTH OF HOSPITALIZATION BY TWO DAYS. DISCHARGED WITHOUT FURTHER SEQUELAE.
DEVICE WAS IMPLANTED ON 4/24/89. THE PUMP WAS REVISED ON 3/20/90. THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS ON 8/5/96 AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A FATIGUE LEAK. TUBING HAD A FATIGUE AND WEAR LEAK.
UNIT CAME APART DURING SURGICAL PROCEDURE. THE WHITE PART WITH RING BROKE APART FROM THE BLACK HANDLE PORTION OF THE UNIT AND REMAINED IN PT. THE SURGEON WAS ABLE TO RETRIEVE THE WHITE RING FROM THE PT AND REPORTS NO HARM TO PT.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO TORN TUBING AT RESERVOIR JUNCTION.
DEVICE WAS IMPLANTED, DATE NOT INDICATED. ON 7/4/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION.
PUMP PERFORMED WITHIN SPECIFICATION. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
STATUS POST RADICAL PROSTATECTOMY ON 8/20/96, ORDER RECEIVED TO DISCONTINUE DRAIN ON 8/22/96. APPROPRIATE PROCEDURE FOLLOWED: SUTURE CUT, SUCTION OFF BULB. ATTEMPTS TO PULL DRAIN MET WITH RESISTANCE. DRAIN TUBING BROKE LEAVING WHITE PLASTIC IN PT'S ABDOMEN. RETURNED TO SURGERY FOR REMOVAL OF RETAINED FRAGMENT. EXTENDED LENGTH OF HOSPITALIZATION BY TWO DAYS. DISCHARGED WITHOUT FURTHER SEQUELAE.
ON 9/3/96 REPORTER STATED THAT THE HOSP WILL RETAIN THE PRODUCT SAMPLE FOR POSSIBLE LEGAL ACTION IN THE FUTURE. PAST HISTORY OF COMPLAINTS OF THIS TYPE HAVE BEEN DUE TO NICKING, SUTURING AND TISSUE INGROWTH.
INFO RECEIVED ON 8/7/96, DIFFICULT ACTIVATION OF A PUMP. ATTEMPTS WERE MADE TO ACTIVATE THE DEVICE BUT THEY WERE NOT SUCCESSFUL. THE DR BENT THE PUMP AND THOUGHT HE FELT A POP BUT THE DEVICE DID NOT ACTIVATE. AFTER 3-5 ATTEMPTS THE DR FELT THAT THE PT WAS SORE AND DECIDED NOT TO MAKE ANY MORE ATTEMPTS. A REVISION SURGERY IS SCHEDULED FOR 9/13/96.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE T0 FLUID LOSS-LEFT CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD TORN FABRIC AND BULGING.
ALLEGED FAILURE OF RADIAL HEAD IMPLANT. IMPLANT INSERTED ON 2/24/95, REMOVED ON 11/9/95. INSPECTION OF IMPLANT BY SURGEON SHOWED SIGNIFICANT ECCENTRIC WEAR ON THE RADIAL HEAD AND THE FRACTURING OF THE STEM AT THE JUNCTION WITH THE HEAD.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
DEVICE WAS IMPLANTED ON 12/20/93. THE PUMP WAS REVISED ON 9/27/95. THE CYLINDERS WERE REMOVED FROM THE PT DUE TO DISTAL URETHRA EROSION ON 8/2/96.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
ON 8/8/96 THE PT REPORTED HIS PUMP "SQUEAKS AND PUMPS REALLY HARD". PT IS NOT HAPPY WITH RESULTS.
A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.
TWO GRAMS PRONESTYL (PROCAINAMIDE) 250 IV FLUID REPORTEDLY SET TO INFUSE VIA IV PUMP AT 15CC PER HR. APPROX 55 MINS AFTER MEDICATION WAS STARTED NURSE REPORTS THAT IV FLUID BAG CONTAINING MEDICATION WAS ALMOST EMPTY ALTHOUGH IV PUMP REPORTEDLY READ TOTAL VOLUME INFUSED AT 14CC. PT HAD DECREASE IN PLATELET COUNT OF UNKNOWN ETIOLOGY ON 5/5. PT HAS HISTORY OF BLOOD TRANSFUSIONS FOR ANEMIA AND DECREASED PLATELETS. PLATELETS GIVEN ON 5/1 AND 5/4 PRIOR TO ALLEGED OVERINFUSION OF PRONESTYL. NO PLATELETS ORDERED BY DR AFTER EVENT PRIOR TO DISCHARGE.
DEVICE WAS IMPLANTED SOMETIME IN 1980. ON 5/21/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION".
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
PT RECEIVED BREAST IMPLANTS 8 YEARS AGO (IE. 1984). PT HAD REMOVAL BECAUSE OF SCAR TISSUE. IMPLANTS WERE REPLACED WITH DEVICES OF ANOTHER MFR. REPORT DEEMED REPORTABLE AFTER CO REVIEW OF FILES.
CONCLUSION: 68 OTHER (NO DEVICE RETURNED).
INSTRUMENTATION SET UP BY NURSE AND NOTED BROKEN INSTRUMENTS. LATER, RESET-UP INSTRUMENTS FOR SAME CASE AND NOTED THE RESECTOSCOPE SHEATH WAS CHIPPED AND DID NOT REMOVE INSTRUMENT FROM STERILE FIELD. UPON USE IN THE PT, SHEATH CHIPPED FURTHER. DR SAW MORE OF SHEATH CHIPS IN BLADDER AND FLUSHED CHIPS OUT OF BLADDER.
DEVICE WAS REMOVED FROM THE PT DUE TO A SYSTEM FAILURE AND REPLACED.
ON 8/20/92, AN AUS DEVICE WAS IMPLANTED. ON 10/22/92, THE CUFF WAS REVISED. ON 7/11/96, THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO CUFF ATROPHY AND RECURRING INCONTINENCE.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO CUFF EROSION.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED BECAUSE PT HAD SOME DIFFICULTY WITH MANUAL MANIPULATION OF PUMP DUE TO ITS POSITION IN SCROTUM.
ON 3/4/96, AN AUS DEVICE WAS IMPLANTED. ON 4/22/96 THE CUFF WAS REVISED. ON 7/1/96, THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CUFF.
D9 - SUPPLEMENTAL INFO RECEIVED STATES DEVICES WERE RETURNED TO THE MFR AFTER REMOVAL SURGERY; HOWEVER, DOW CORNING HAS NO RECORD OF RECEIPT OF THESE DEVICES.
PATIENT ALLEGES HAVING PNEUMONIA AND BRONCHITIS FOR WEEKS AT A TIME, LYMPH NODES ON HER NECK, SHE DEVELOPED SHINGLES WHICH AFFECTED HER HEAD AND BACK FROM THE TOP OF HER HEAD TO HER EYES, SHE WAS IN PAIN, SHE DEVELOPED GALLSTONES, HAD BLADDER PROBLEMS, SHE HAS BACK PAIN, ABDOMINAL PAIN, ASTHMA ATTACKS, HEAVY COUGH AND A CT SCAN REVEALED RUPTURED IMPLANT AND A SPOT ON HER LUNGS.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WOULD NOT DEFLATE AND REPLACED.
ON 9/9/93, AN AUS DEVICE WAS IMPLANTED. ON 2/28/94, THE CUFF WAS REVISED. ON 5/27/96, THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CUFF.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-HOLE IN RIGHT CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK.
PT RECEIVED BREAST IMPLANTS ON 5/29/86. MAMMOGRAM PRIOR TO REMOVAL INDICATED RUPTURE OF RIGHT IMPLANT; THEREFORE, SHE HAD REMOVAL OF RIGHT IMPLANT ON 11/25/92. REPORT DEEMED REPORTABLE AFTER CO REVIEW OF FILES.
REPORT SHOWS DEVICE WAS RETURNED TO MFR IN 11/92; HOWEVER, DOW CORNING HAS NO RECORD OF RECEIVING THIS DEVICE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AT TUBING FROM PUMP AND REPLACED.
PUMP HAD A FATIGUE LEAK. CYLINDER PERFORMED WITHIN SPECIFICAIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
ON 8/7/89 AN AUS DEVICE WAS IMPLANTED. ON 6/8/90, AND 4/13/94, THE CUFF WAS REVISED. ON 8/5/96, THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS.
SMOKE EVACUATOR WAS BEING USED FOR A BREAST REDUCTION FOR APPROX ONE HR. RPTR SAW SMOKE AND RED SPARKS COMING OUT OF THE FRONT OF THE MACHINE. A HOLE QUICKLY BURNED THROUGH THE MACHINE. MACHINE WAS TURNED OFF AND REMOVED FROM THE OR. BIO-MED REPORT: THIS UNIT IS A DEMO. THE FRONT PANEL MELTED NEAR THE FILTER CONNECTOR. IT HAS A RIBBON CABLE SUPPLYING POWER TO A FRONT PANEL WARNING "SINGLE USE FILTERS." "FLOW" SET AT MAX; "TIME" SET AT 1/4 CW.
PT RECEIVED BREAST IMPLANTS 18 YEARS AGO (IE, 1978) OF AN UNK MFR. REPORT ALLEGES PT'S IMPLANTS GOT HARD; THEREFORE, SHE HAD REMOVAL AND REPLACEMENTS ON AN UNK DATE AND OF AN UNK MFR.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WAS "NON-FUNCTIONING." A MALLEABLE DEVICE WAS IMPLANTED.
RECEIVED PT FROM ER WITH IV 9NS AND IVPB 100ML D5W WITH 10 KCL RUNNING AT 500 ML/HR. MAINLINE ORDERED AT 500 ML/HR BOLUS X3. HOWEVER, IVPB WAS RUNNING UPON ARRIVAL TO FLOOR. K+ IVPB IMMEDIATELY DISCONTINUED AND IV DOWN TO 100 ML/HR. DR HERE AND EXAMINED PT: VSS 98.7-93-16-120/68. HEART RATE IRREGULAR, COLOR PALE, SKIN DRY, LUNG CLEAR A+P BILATERAL. NO EDEMA, PT RECEIVED 1 K+ IVPB (100 ML D5W WITH 10KCL IVPB) BOTH ORDERED FROM ER. HUMAN ERROR; QUESTION DESIGN OF EQUIPMENT AS POSSIBLE CONTRIBUTOR.
ON 8/10/92, AN AUS DEVICE WAS IMPLANTED. ON 6/30/95, THE CUFF WAS REVISED. ON 7/15/96, THE BALLOON WAS REVISED. ON 8/8/96, THE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION-THROUGH SCROTUM.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECS. BALLOON PERFORMED WITHIN SPECS.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO BLOOD INSIDE SYSTEM AND FLUID LOSS-BOTH CYLINDERS.
RESERVOIR PERFORMED WITH SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CYLINDER HAD OR DAMAGE. TUBING HAD OR DAMAGE. TUBING WAS FUNCTIONAL.
PT RECEIVED BREAST IMPLANTS ON AN UNK DATE, OF AN UNK MFR AND AS REPLACEMENTS. REPORT ALLEGES PT'S IMPLANTS BROKE; THEREFORE, SHE HAD REMOVAL AND REPLACEMENTS WITH SALINE DEVICES OF AN UNK MFR.
CONCLUSION: 68 OTHER (NOP DEVICE RETURNED)).
TIP OF THE REAMER OUT OF RUSH ROD INSTRUMENTS, BROKE OFF INTO HUMERUS WHILE SURGEON WAS HAMMERING ON IT. THE 3/32" TIP IS DEEP IN THE BONE AND CANNOT BE RETRIEVED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO CUFF.
INFO RECEIVED ON 8/8/96 INDICATES DEVICE WAS REMOVED FROM THE PT ON 8/6/96,  REASON NOT INDICATED. INFO ACQUIRED ON 8/14/96 INDICATES THE OTHER DEVICE WAS REMOVED FROM THE PT AND AN IPP DEVICE WAS IMPLANTED DUE TO PAIN, DATE NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
SCREW FELL OFF HEATING COIL INSIDE DEVICE. ONLY ONE SCREW PRSENT, CAUSING AIR LEAK SO PT RECEIVED NO O2 THROUGH VENT. "PT LOW PRESSURING" AND BREATHING ON OWN. SCREW REPLACED AND LEAK STOPPED. PT BREATHING RESUMED NORMALLY.
DURING ANTERIOR CRUCIATE LIGAMENT REPAIR AND RECONSTRUCTION A 7MM TRANSTIBIAL GUIDE TIP BROKE OFF IN THE JOINT AND WAS RETRIEVED BY THE SURGEON. THERE WAS NO ADVERSE EFFECT OR INJURY TO THE PT.
THE PUMP WAS REMOVED FROM THE PT DUE TO EROSION AT SCROTAL AREA AND REPLACED.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO URINARY RETENTION.
THE CUFF WAS REMOVED FROM THE PT DUE TO FLUID LOSS AT BLADDER NECK AND REPLACED.
PT STRAIGHT CATH'D FOR RESIDUAL URINE. UNABLE TO OBTAIN URINE; NO URINE RETURNED. PT THEN CATH'D WITH A FOLEY PER DR WITH APPROX 90CC URINE OBTAINED.
DURING STENT PLACEMENT, WHEN THE BALLOON WAS REMOVED, A PORTION OF THE BALLOON AND SHAFT BECAME DISLODGED WITHIN THE ARTERY. THE FOREIGN BODY WAS THEN RETRIEVED. NO ILL EFFECTS TO THE PT WERE NOTED.
REPORT ALLEGES PT RECEIVED IMPLANTS 14 YEARS AGO (I.E. 1982). REPORTER ALLEGES PT HAD SURGERY THREE WEEKS AGO (I.E. 7/96) AND DISCOVERED THAT ONE OF HER IMPLANTS HAS RUPTURED. REPORTER ALSO ALLEGES CO WAS STAMPED ON THEM (IMPLANTS).
CONCLUSION: 68 OTHER (NBO DEVICE RETURNED).
THE END OF A CURETTE BROKE OFF DURING USE IN THE FEMORAL CANAL. UNABLE TO FIND THE END OF THE CURETTE. X-RAY SHOWS DISTAL TO THE COMPONENT OF THE HIP PROSTHESIS WITHIN THE CEMENT IS A METALLIC DENSITY FRAGMENT MEASURING 6 X 3 MM.
THE CUFF WAS REMOVED FROM PT DUE TO PT DISSATISFACTION-DRIPPING WHEN COUGHS AND REPLACED.
PT DEVELOPED HIVES ON LEGS AND ABDOMEN IMMEDIATELY AFTER PLACEMENT ON 8/30. 25MG PO BENADRYL GIVEN AND 25 MG BENADRYL GIVEN IVP W/IN 10 MINS AND HIVES SUBSIDED. HAD ONLY USED 20ML OF NS FLUSH IV AND 5CC OF 100U/ML HEPARIN IV WITH CATHETER BEFORE IT WAS DC'D. CATHETER WAS IN L BASILIC VEIN. A TOTAL OF APPROX 15 MINS BEFORE IT WAS DC'D.
D6 - LOT NUMBER PROVIDED IS INCONSISTENT WITH DOW CORNING NUMBERING SYSTEM.
PATIENT ALSO ALLEGES REMOVAL OF BOTH IMPLANTS IS NECESSARY.
REPORT ALLEGES PT RECEIVED BREAST IMPLANTS ON AN UNK DATE. PT STATES "HAD A RUPTURE."
THE SWITCH EMITTED SMOKE. NO DEATHS OR INJURIES WERE REPORTED. THE UNIT HAS NOT BEEN RETURNED TO CO FOR INSPECTION AND MAY NOT BE. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT GREATER THAN LABELED?Y. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS SEVERITY OF THIS EVENT GREATER THAN LABELED? N.
THE CUFF AND BALLOON WERE REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE AND REPLACED.
CUFF PERFORMED WITHIN SPECS. BALLOON PRESSURE NO WITHIN SPECS.
REPORT ALLEGES PT RECIEVED BREAST IMPLANTS ON AN UNK DATE. REPORT ALSO ALLEGES THE IMPLANTS HAVE MADE THE PT SICK.
REPORT ALLEGES PT RECEIVED IMPLANTS ON 4/3/81. SHE ALLEGED RIGHT NOW HAVING PROBLEMS, INCLUDING FATIGUE, NIGHT SWEATS AND MYALGIA. SHE ALSO ALLEGES SHE GOT MEDICAL DOCUMENTATION ASSOCIATED WITH ATYPICAL CONNECTIVE TISSUE DISEASE.
THE CUFF WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE AND REPLACED.
THE BALLOON AND PUMP WERE REMOVED FROM THE PT DUE TO INFECTION.
PUMP PERFORMED WITHIN SPECS. CUFF AHD OR DAMAGE. BALLOON AHD OR DAMAGE.
CONCLUSION: 68A - NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN
PHYSICIAN REPORTED PT'S RECENT MAMMOGRAM SHOWED EVIDENCE OF A "HERNIATION/RUPTURED" IMPLANT.
PROBLEMS: ENCAPSULATION, MILD ON THE RIGHT SIDE AND SEVERE ON THE LEFT SIDE.
PT RECEIVED IMPLANTS IN 1984. REPORT ALLEGES IMPLANTS BECAME HARD; THERFORE, SHE HAD THEM REMOVED AND REPLACED IN 1985.
PT RECEIVED IMPLANTS IN 11/94. PT ALLEGES HAVING AN IMPLANT THAT IS LEAKING; THEREFORE, BOTH IMPLANTS WERE REMOVED AND REPLACED ON 8/16/96, MAMMOGRAM OBTAINED ON 6/12/96 SHOWED A BROKEN IMPLANT ON THE LEFT SIDE.
PT RECEIVED IMPLANTS OF AN UNK MFR AND ON AN UNK DATE. REPORTER ALLGES "WE JUST REMOVED BREAST IMPLANTS FROM A PT." NO OTHER INFO PROVIDED.
STAFF MEMBERS WERE TREATING A MALE PT IN HIS FORTIES WHO WAS DESCRIBED AS BEING IN "ASYSTOLIC MEDICAL FULL ARREST." THE STAFF ATTEMPTED TO PACE THE PT, BUT THEY INDICATED THAT THE UNIT DID NOT PROVIDE ANY PACER OUTPUT. THE STAFF TURNED THE UNIT'S MA SETTING TO 140, BUT THE UNIT DISPLAYED 0 MA'S. THE STAFF OBTAINED A PD1400 (SERIAL NUMBER UNKNOWN) AND CONTINUED TO CODE. THE STAFF TREATED THE PT FOR OVER AN HR AND THEN CALLED THE CODE. THE PT DID NOT SURVIVE THE CODE.
PT ALLEGES HAVING PROBLEMS INCLUDING, RASHES, LUPUS ERYTHEMATOSIS, RHEUMATOID DISEASE AND OTHER SYSTEMIC CONDITIONS. PT ALSO ALALEGES ALLERGIC DERMATITIS. MEDICAL RECORDS STATE PT RECEIVED IMPLANTS ON 3/11/75.
THE DEVICE CATHETER BROKE OFF AT THE CLAVICLE. THE DISTAL PORTION OF THE DEVICE CATHETER HAD MIGRATED TO THE PULMONARY ARTERY. THE MIGRATED CATHETER WAS REMOVED BY THE RADIOLOGIST WITHOUT INCIDENT. THE DEVICE AND REMAINING CATHETER WERE SCHEDULED TO BE REMOVED ON 8/16/96. THE PT WAS STATED TO BE AN ACTIVE GOLFER WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR ACCORDING TO THE PHYSICIAN.
FURTHER COMMUNICATION WITH PHYSICIAN, ON 8/21/96, REVEALED THAT HE WOULD LIKE TO RETAIN THE DEVICE AT THIS TIME. SINCE THE DEVICE IS UNAVAILABLE FOR ANALYSIS AT THIS TIME, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG/LOT NUMBER AND A TREND WAS NOT IDENTIFIED. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
DEMEROL 5MGM OR 0.5 ML ORDERED VIA PCA II BASELINE. CAREGIVER PROGRAMMED PUMP TO DELIVER 5 ML. PT RECEIVED APPROX 700-900MGM OF DEMEROL IN AN 8-10 HR PERIOD RESULTING IN ALTERED MENTAL STATUS, DISORIENTATION, TWITCHING BUT NOT SEIZURES. PT TRANSFERRED TO ICU." THE PT IS REPORTED TO BE "BETTER NOW." THE PUMP HAS BEEN CHECKED BY BIOMED AT THE HOSP AND HAS BEEN PLACED BACK INTO SVC.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO A FLUID LOSS-PUMP LEAK-AND REPLACED.
PUMP TUBING JUNCTION HAD A FATIGUE LEAK. CUFF PERFORMED WITHIN SPECS. BALLOON PERFORMED WITHIN SPECS.
EVALUATION OF PUMP WAS PERFORMED BY HOSP'S BIOMED DEPT. SUBSEQUENTLY THE HOSP DECIDED TO RETURN THE PUMP TO SVC AND NOT RETURN IT TO MFR FOR EVALUATION.
AN AUS DEVICE WAS REMOVED FORM THE PT DUE TO SEPSIS, DATE NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
PUMP PERFORMED WITHIN SPECS. CUFF PERFORMED WITHIN SPECS. BALLOON PRESSURE NOT WITHIN SPECS.
X-TUBE ASSEMBLY 20" X 16". DEALER CLAIMS X-TUBE BROKE. DEALER SAYS THE CUSTOMER WAS ON VACATION WHEN THE X-TUBE BROKE AT THE CENTER HOLE LOCATION.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. OR ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING SURGERY ON 8/8/96, THE PHYSICIAN ATTEMPTED TO INTRODUCE THE DEVICE "J-WIRE" INTO THE DEVICE INTRODUCER NEEDLE; HOWEVER, IT "CRIMPED" AND HE WAS UNABLE TO ADVANCE OR REMOVE IT. AS A RESULT, THE "SPINAL" DEVICE NEEDLE AND J-WIRE WERE REMOVED AND THE DEVICE WAS IMPLANTED USING A DIFFERENT INTRODUCER.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED WITH THE FOLLOWING RESULTS: TEH DEVICE GUIDEWIRE WAS CAUGHT INSIDE THE 18 GAUGE DEVICE NEEDLE AS RECEIVED. SLIGHT PRESSURE FREED THE DEVICE GUIDEWIRE AND EXPOSED MATERIAL WHICH GENERATED FOURIER TRANSFORM INFRA RED (FTIR) SPECTRA CONSISTENT WITH BIOLOGICAL/PROTEIN MATERIAL. AFTER FREEING THE DEVICE GUIDEWIRE, PROPER FUNCTION WAS ACHIEVED. THE DEICE GUIDEWIRE FIT THE RETURNED DEVICE NEEDLE AND A CONTROL DEVICE NEEDLE FROM THE SAME LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY MFG VARIANCES APPLICABLE TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMIALR REPORTS INVOLVING THIS CATALOG/LOT NUMBER AND NI TRENDS HAVE BEEN IDENTIFIED. THE FACILITY'S REPORT OF BEING "UNABLE TO ADVANCE THE GUIDEWIRE" WAS CONFIRMED BY THE MFR'S ANALYSIS AND WAS DETERMINED TO BE DUE TO RESIDUE (BIOLOGICAL/PROTEIN MATERIAL) WHICH WAS IN THE DEVICE GUIDEWIRE. THE MANNER IN WHICH THE MATERIAL WAS INTRODUCED; HOWEVER, COULD NOT BE DETERMINED. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS REPORT.
X-TUBE ASSM 19" X 17". DEALER CLAIMS THE X-TUBE IS BROKEN.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND ANY RELEASED BY FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE PUMP WAS REMOVED FROM THE PT DUE TO INFECTION.
X-TUBE ASSM 17" X 17". DEALER CLAIMS THE X-TUBE IS BROKEN AT SEAT RAIL. HE STATES THAT THE ALLEGED BREAK OCCURRED AT THE CONSUMER'S HOME, AND THAT NO INJURY OCCURRED.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS DEFECTIVE AND HAD A CRACK IN IT. IT WAS ADDITIONALLY STATED THAT THERE WAS SOME LEAKAGE FROM THE DEVICE. ON 8/27/96, THE DISTRIBUTOR CONTACTED THE MFR AND STATED THAT THE DEVICE WAS IMPLANTED ON 11/10/95 FOR USE IN THE PT'S THERAPY. ON 8/5/96, THE DEVICE CATHETER WAS DISCOVERED TO BE LEAKING. AS A RESULT, THE DEVICE WAS EXPLANTED ON 8/6/96.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: NORMAL USAGE WAS EVIDENT ON THE DEVICE SEPTUM WITH NO INTERNAL FRACTURE PLANE DAMAGE FOUND. INITIAL VISUAL EXAMINATION OF THE POLYURETHANE DEVICE CATHETER REVEALE FOUR PARALLEL LONGITUDINAL SLITS APPROX. 3 1/2" FROM THE DISTAL END. YELLOW DISCOLORATION WITH SOME COMPLRESSION WAS ALSO SEEN AT THE DAMAGED AREA OF THE DEVICE CATHETER. TEH DAMAGE FOUND WAS CONSISTENT WITH CATHETER SHEAR, SECONDARY TO PINCH-OFF SYNDROME. THE DEVICE WAS PATENT UPON FLUSHING WITH NO RESISTANCE FELT AND APPROX. 5ML OF CLEAR, COLORLESS FLUID WITH LIGHT AND AMBER COLORED PARTICLES WAS COLLECTED WHICH TESTED POSITIVE FOR BLOOD. THE DEVICE WITHSTOOD A PRESSURE IN EXCESS OF 60PSI WITH THE EXCEPTION OF THE DAMAGED AREA OF THE DEVICE CATHETER. NO OTHER ANOMALIES WERE FOUND. AS PART OF OUR INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. IN CONCLUSION, THE REPORT OF A "CRACK" AND "LEAKAGE" WERE CONFIRMED BASED ON THE EVIDENCE OF LONGITUDINAL SLITS IN THE DEVICE CATHETER. BASED ON THE INFO AVAILABLE, AND THE DEVICE ANALYSIS, THE MFR BELIEVES THIS EVENT IS ATTRIBUTABLE TO DEVICE CATHETER PLACEMENT AND NOT TO THE DEVICE. THE DEVICE LABELING CONTAINS WARNINGS ON DEVICE CATHETER PLACEMENT.. AN ARTICLE WILL BE FORWARDED TO THE FACILITY IDENTIFYING PINCH-OFF SYNDROME AS A POSSIBLE CAUSE OF FAILURE IN AN EFFORT TO PREVENT RECURRENCE OF THIS EVENT IN THE FUTURE. NO FURTHER INFO IS AVAILABLE. TEH MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE PT WAS HAVING A ROUTINE CXR AS PART OF HER FOLLOWUP FOLLOWING CHEMOTHERAPY. DURING THE X-RAY THE RADIOLOGIST NOTED THAT THE PORT-A-CATH CATHETER WAS SEPARATED FROM THE PORT. THE PT WAS BROUGHT TO THE SPECIAL PROCEDURES DEPT FOR RETRIEVAL OF THE PORTION OF THE CATHETER. THE PORT WILL BE EXPLANTED AT A LATER DATE. THE PT WAS NOT AWARE OF A PROBLEM AND THE PORT WAS NOT BEING USED FOR CHEMOTHERAPY AT THE TIME.
X-TUBE ASSM 19"X16". DEALER CLAIMS THE X-TUBE IS BROKEN AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT OF INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT RECEIVED IMPLANTS IN 1983. PT ALLEGES HAVING IMPLANTS REMOVED IN 1989 BECAUSE OF A RUPTURE.
THE PORT WAS IMPLANTED ON THE LEFT SIDE IN 5/95, FOR CHEMOTHERAPY. THE PT FELT BURNING DURING CHEMOTHERAPY AND THE PT'S LEFT ARM AND NECK REPORTEDLY BECAME SWOLLEN. THE PORT WAS REMOVED AND REPLACED. THE PT REPORTED SCARRING ON THE NECK AND A BLOOD CLOT ON THE LEFT SIDE.
A MEMBER OF THE IMPLANTING DR'S STAFF STATED THAT ALL THAT COULD BE CONFIRMED REGARDING THIS INCIDENT WAS THAT THE PT HAD A PROBLEM WITH THE PORT.
X-TUBE ASSM 16"X17". DEALER CLAIMS THE X-TUBE BROKE AT THE BOTTOM.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REPORTER ALLEGES RECEIVING IMPLANTS IN 1986. SHE ALLEGES JOINT PAIN.
THE PT WENT INTO A SCHEDULED SURGERY ON 8/7/96 FOR A LEAD REVISION, BECASUE THE PHYSICIAN HAD OBSERVED NOISE ON THE ELECTROGRAMS DURING A ROUTINE FOLLOW-UP VISIT WHICH HE ATTRIBUTED TO THE LEAD. THE PHYSICIAN OPENED THE POCKET AND REMOVED THE V-100C DEFIBRILLATOR FROM THE POCKET. AFTER IMPLANTING A NEW PACE SENSE LEAD (BT-10) HE ATTACHED THE LEAD TO THE V-100C DEFIBRILLATOR AND STILL OBSERVED NOISE. HE THEN TESTED THE CHRONIC LEAD (MFG BY A 2ND CO) S/N 010066 WHICH HAD BEEN ORIGINALLY IMPLANTED IN THE PT ON 11/28/94 AND OBSERVED NO NOISE. HE ATTACHED AND TESTED A V-115C, S/N 2964 WITH THE EXISTING OTHER CO'S LEAD AND OBSERVED NO NOISE. THE PHYSICIAN CHOSE TO EXPLANT THE BT-10 LEAD AND THE V-100C DEFIBRILLATOR.
A4. THE INITIAL REPORT STATES NA FOR WEIGHT. CO DOES NOT PROVIDE PATIENT WEIGHT BECAUSE IT HAS NO IMPACT ON THE SAFETY OR EFFECTIVENESS OF CO'S DEVICES. H-3 EVALUATION SUMMARY: THE DEVICE APPROPRIATELY DETECTED AND DELIVERED PULSES AT DIFFERENT PROGRAMMED VOLTAGE LEVELS WHEN CONNECTED TO A CARDIAC SIMULATOR. ADD'L TESTING VERIFIED THAT THE BRADYCARDIA PACING, ANTITACHYCARDIA PACING, AND SENSING FUNCTIONED PROPERLY. ACCURATE HIGH VOLTAGE CHARGING AND DEFIBRILLATION OUTPUT WAS FURTHER CONFIRMED DURING ELECTRICAL LIFE TEST. VARIOUS GENERAL PARAMETERS INCLUDING ELECTROGRAM STORAGE, BATTERY VOLTAGE, AND TELEMETRY RESPONSES OF THE DEVICE WERE ALSO TESTED AND VERIFIED AS FUNCTIONING PROPERLY. THE DEVICE MET ALL PERFORMANCE SPECS AND SHOWS NORMAL DEVICE CHARACTERISTICS.
X-TUBE ASSM 17"X16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER PIVOT HOLE LOCATION. PART WILL NOT BE RETURNED.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT RECEIVED IMPLANTS ON AN UNK DATE. PT STATES SHE HAS BAD MEMORY LOSS AND HAS HAD THREE SURGERIES.
ON 8/13/96, THE PT CONTACTED A MFR NURSE AND REPORTED THAT HER FIRST VASCULAR ACCESS DEVICE HAD BEEN EXPLANTED BECAUSE SHE WAS IN REMISSION AND THERE HAD NOT BEEN ANY PROBLEMS WITH THE DEVICE. THE PT THEN STATED THAT HER SECOND DEVICE HAD A TENDENCY TO CLOT AND SHE COULD FEEL PAIN IN HER SHOULDER UPON USE. THE FACILITY NURSE WAS UNABLE TO DRAW BLOOD AND "FORCED SALINE THROUGH" THE DEVICE, WHICH WAS EXTREMELY PAINFUL. IN ADDITION, THERE WAS SWELLING OVER THE DEVICE SITE. THE PT REPORTED THAT SHE WAS THEN SENT TO RADIOLOY, WHERE IT WAS NOTED THAT THE DEVICE CATHETER HAD "DISCONNECTED" FROM THE DEVICE BODY. THE PT WAS THEN TAKEN INTO SURGERY ON AN "EMERGENCY BASIS" WHERE THE DEVICE WAS EXPLANTED AND A NEW ONE WAS IMPLANTED. THE PT STATED THAT SHE WAS UNDER THE IMPRESSION THAT THE DEVICE WOULD BE RETURNED TO THE MFR, HOWEVER, THE DEVICE HAD NOT BEEN RETURNED TO DATE. THE PT STATED THAT SHE DOES NOT WANT THE MFR TO CONTACT HER PHYSICIAN AND DID NOT WANT TO BE PERCEIVED AS "A TROUBLEMAKER". THE PT STATED THAT SHE WOULD LIKE TO HAVE THE DEVICE EXAMINED, WITH A DETERMINATION OF "WHAT HAPPENED TO IT". THE MFR NURSE THEN CONTACTED THE FACILITY'S LEGAL AFFAIRS DEPARTMENT, AFTER TRYING UNSUCCESSFULLY TO OBTAIN INFO CONCERNING THE LOCATION OF THE DEVICE FROM THE OTHER DEPARTMENTS AT THE FACILITY. THE FACILITY LEGAL AFFAIRS REPRESENTATIVE STATED THAT THE PT WOULD BE CONTACTED CONCERNING THE LOCATION OF THE DEVICE.
ON 8/30/96, THE MFR NURSE ATTEMPTED TO CONTACT THE PT TO OBTAIN AN UPDATE ON THE DEVICE LOCATION. TEH PT'S SPOUSE REPORTED THAT THE FACILITY HAD CONTACTED HIS WIFE AND REPORTED THAT THE DEVICE HAD BEEN DISCARDED; THEREFORE, IT WOULD NOT BE RETURNED TO THE MFR'S FOR ANALYSIS. SINCE THE DEVICE WAS DISCARDED AND THE PT REQUESTED THAT THE MFR NOT CONTACT THE  PHYSICIAN, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD FOR THIS CATALOG/LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CATALOG/LOT NUMBER AND NO MFG VARIANCED WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITIONM A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CATALOG/LOT NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. BASED ON THE AVAILABLE INFO, AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE PT WILL NOTIFIED OF THE MFR'S REVIEW OF THIS INCIDENT. NO FUETHR DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS REPORT.
PT RECEIVED IMPLANTS IN 1981. SHE ALLEGES REMOVAL OF IMPLANTS ON 4/9/96, DUE TO HEARING ABOUT PROBLEMS ON TELEVISION AND RADIO. REPORTER ALSO ALLEGES "I WAS AFRAID I WOULD GET SICK, THEREFORE, I HAD THEM REMOVED."
ON AUGUST 7, 1996 ADDITIONAL INFO WAS REQUESTED AND SUBSEQUENTLY RECEIVED FROM REPORTER. THE INITIAL REPORT WAS SUBMITTED BASED ON BEST AVAILABLE INFO PROVIDED BY THE REPORTER. NO ADDITIONAL INFO FROM REPORTER IS ANTICIPATED. EXPLANATION OF MISSING INFO: D5 - AN EXPIRATION DATE DOES NOT APPLY FOR THIS DEVICE. E1 - THIS INFO WAS NOT PROVIDED BY THE REPORTER ON EITHER THE INTIAL CONTACT OR THE FOLLOW-UP INVESTIGATION. E2 - UNK IS THE MOST APPROPRIATE RESPONSE SINCE REPORTER FAILED TO INDICATE ON FOLLOW-UP INVESTIGATION. F4, F6, F8, F9, F10, F12 - UNK IS A "SYSTEM" DEFAULT. THIS REPROT IS BELIEVED TO BE MADE BY THE PATIENT AND THUS SECTION F IS NOT APPLICABLE.
QR AXLE W/NUT. DEALER CLAIMS THAT THE SPRING AND BEARINGS FELL OUT.
STAKING AT HOLE NOT SUFFIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PORT WAS INSERTED ON 4/22/96. AFTER 2ND DOSE OF ADRIAMYCIN/CYTOXIN-DEVELOPED RED AREA AROUND PORT-PORT WAS REMOVED ON 5/22/96. AREA WAS LEFT OPEN FOR PACKING. STAFF OBTAINED GOOD BLOOD RETURN PRIOR TO ADMINISTERING AND THROUGH CHEMO ADMINISTRATION.
X-TUBE ASSM 20"X16". DEALER CLAIMS THE CROSSBRACE IS BROKEN NEAR THE BOLT.
ON 8/8/96, THE PT'S DAUGHTER RESPONDED TO THE MFR'S DEVICE TRACKING POLLING LETTER. THE RESPONSE STATES "PT DECEASED AS OF 3/16/96. DEVICE REMOVED 2/96 DUE TO COMPLICATIONS. IT DID A GREAT JOB WHILE IMPLANTED." SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO; HOWEVER, THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL TO DATE.
ON 9/26/96, THE ONCOLOGIST'S SECRETARY CONTACTED THE MFR WITH ADD'L INFO CONCERNING THIS EVENT. THE ONCOLOGIST'S SECRETARY INFORMED THE MFR THAT THE PT HAD A RECURRING, BLEEDING ABDOMEN AND EXPLAINED THAT AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND REVEALED A DUODENAL ULCER WHICH LEAD TO THE REMOVAL OF THE DEVICE. THE ONCOLOGIST SECRETARY SUGGESTED THE MFR CONTACT THE EXPLANTING PHYSICIAN FOR ADD'L INFO. ON 9/30/96, THE MFR CONTACTED THE EXPLANTING PHYSICIAN WHO STATED THAT THE DEVICE WAS REMOVED DUE TO THE DEVICE TUBING ERODING THROUGH THE GDA INTO THE DUODENUM, CAUSING AN ULCER. ON 10/02/96, THE MFR CONTACTED THE EXPLANTING PHYSICIAN'S OFFICE FOR CLARIFICATION OF WHAT CAUSED THE PT'S ULCER. ON 10/03/96, THE FACILITY NURSE CONTACTED THE MFR AND STATED THAT THE PHYSICIAN BELIEVES THE DUODENAL ULCER WAS CAUSED BY POST COMPLICATIONS, POST RADIATION AND THAT THE CAUSE OF THE DEVICE TUBING ERODING IS UNK. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENT  INVOLVING THIS CATALOG NUMBER AND DID NOT REVEAL ANY TRENDS. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MANUFACTURING VARIANCES IN RELATION TO THIS EVENT. BASED ON THE INFO AVAILABLE, THE DEVICE WAS REMOVED DUE TO THE DEVICE TUBING ERODING; HOWEVER, THE CAUSE OF THIS EROSION CANNOT BE DETERMINED. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
PT UNDERWENT SPINAL PROCEDURE ON 8/6/96. PT HAD RIGHT THORACIC CURVE 58 DEGREES PRE-OPERATIVE. HE UNDERWENT AN ANTERIOR RELEASE ONE WEEK PRIOR TO SURGERY. DURING SURGERY CO SYSTEM WAS PLACED FROM T4-T12. THE CURVE WAS CORRECTED TO 21 DEGREES USING ROTATION AND DISTRACTION MANEUVERS. EVERYTHING WAS NORMAL ONE HOUR POST-OP. DURING THE FIRST NIGHT PT LOST MOTOR AND SENSORY IN LOWER EXTREMITIES. NEUROLOGICAL EXAM REVEALED T6 LEVEL. THE FOLLOWING MORNING THE CO IMPLANTS WERE REMOVED. NO OR LIMITED IMPROVEMENT IN NEUROLOGICAL COMPLICATIONS. THREE DAYS POST-OP MRI REVEALED A SPINAL STROKE (INFARCTION) AT T3. SURGEON DOESN'T BELIEVE STROKE RELATED TO IMPLANTS.
ENGINEERING BELIEVES THERE IS NO POSSIBLE REASON FOR THE IMPLANTS DESIGN TO BE RELATED TO THIS INCIDENT.
THE PORT WAS PLACED 7/30/96. THE PT DEVELOPED AN INFECTION AND THE PORT WAS REMOVED ON 8/5/96. AFTER REMOVAL, A CULTURE WAS DONE OF THE TIP OF THE CATHETER. IT WAS REPORTED THAT THE SAME ORGANISM WAS ON THE CATEHTER TIP AS HAD INFECTED THE PT.
QR AXLE MAG W/NUT. DEALER CLAIMS THE BALL BEARINGS FELL OUT OF THE QR AXLE.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A PTCA CASE IN WHICH A CONTRAST CONTROLLER WAS IN USE, A PT WAS INJECTED WITH SEVERAL AIR BUBBLES. PHYSICIAN INTERVENTION WAS NECESSARY TO STABILIZE PT CONDITION. CONDITION WAS SUCCESSFULLY STABILIZED.
VISUAL EXAMINATION OF THE PRODUCT DID NOT REVEAL ANY DEFECTS. SIMULATED USE TESTING DID NOT PRODUCE ANY ABNORMAL RESULTS. IN-SERVICING OF THE CUSTOMER BY THE SALES REP REVEALED THAT THE CUSTOMER WAS USING THE PRODUCT INCORRECTLY AND THAT THE EVENT HAD BEEN TECHNIQUE RELATED RATHER THAN A PRODUCT MALFUNCTION. THE REPORTED EVENT IS NOT OCCURRING MORE FRQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF CO THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
INSUFFICIENCY AND 2 TORN LEAFLETS DUE TO PROLAPSE.
ON 8/8/96, THE MFR RECEIVED A RESPONSE TO A DEVICE TRACKING POLLING LETTER WHICH STATED THAT THE DEVICE WAS EXPLANTED "LAST 6/96, NO BENEFIT FROM INTRATHECAL MORPHINE".
FURTHER COMMUNICATION WITH THE PHYSICIAN, ON 8/28/96, REVEALED THAT THE DEVICE WAS REMOVED DUE TO A DECREASE IN THERAPEUTIC RESPONSE AND NOT DUE TO ANY PROBLEMS ASSOCIATED WITH THE FUNCTION OF THE DEVICE. APPARENTLY, THE PT HAD BEEN TRYING TO WORK WITH THE DEVICE FOR ABOUT A YEAR, STARTING WITH 1MG/DAY AND INCREASING TO 25MG/DAY. THE PT'S RESPONSE TO MORPHINE CONSISTENTLY DECREASED UNTIL A DECISION WAS MADE TO REMOVE THE DEVICE. ALTHOUGH THE PT HAD A PROBLEM ONCE WITH THE CATHETER SLIPPING OFF AND COILING AROUND THE PUMP; THIS PROBLEM WAS CORRECTED AND FLUOROSCOPY INDICATED GOOD POSITION. BASED ON THE INFO AVAILABLE THIS EVENT DOES NOT APPEAR TO BE ATTRIBUTABLE TO THE DEVICE OR A DEVICE MALFUNCTION. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
REGURGITATION, STRUCTURAL FAILURE, 'DEGENERATION', AND LEAFLET DISRUPTION TEAR WERE REPORTED.
H3: EXAMINATION OF THE VALVE IN CO'S LABORATORY REVEALED HOST TISSUE OVERGROWTH ENCROACHED ONTO EACH CUSP WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS, INCLUDING DETACHMENT OF THE RIGHT AND NONCORONARY CUSPS, AND INCOMPLETE COAPTION. X-RAY ANALYSIS REVEALED CALCIFICATION WITHIN THE AORTIC WALL OF EACH CUSP. SLIGHT STENT DISTORTION WAS NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THE VALVE WAS DETERMINED TO BE DUE TO HOST TISSUE OVERGROWTH. H6: 86=X-RAY ANALYSIS.
X-TUBE ASSM 18"X16" PNTD. DEALER ALLEGES THE X-TUBE BROKE AT THE CENTER BOLT. THE CUSTOMER CLAIMS WHILE PULLING CHAIR OUT OF THE CAR THE TUBE JUST SNAPPED INTO TWO PIECES.
WAITING FOR RETURN OF DEVICE TO PERFORM EVAL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE EVENT OCCURRED WHEN ANESTHESIA WAS GIVEN ON FLYING HOSP ON A MISSION OVERSEAS. THIS WAS REPORTEDLY THE FIRST USE OF A HALOTHANE VAPORIZER THAT HAD BEEN ACQUIRED FROM A REMANUFACTURE. THE SURGERY WAS TO CORRECT STRABISMUS. THE PT HAD A SUDDEN CARDIOVASCULAR COLLAPSE SOON AFTER THE START OF INDUCTION. THE ANESTHESIOLOGIST STOPPED THE HALOTHANE BUT CONTINUED TO SMELL HALOTHANE IN THE SYSTEM FOR SOME TIME. THE PT SUFFERED PERMANENT ANOXIC BRAIN DAMAGE AND WILL REQUIRE LONG TERM CUSTODIAL CARE. HE REQUIRED ACLS INCLUDING COUNTERSHOCK.
1. THE VAPORIZER HAD A SIGNIFICANT LEAK AT THE ON/OFF SWITCH CAUSED BY A DEPOSIT OF FOREIGN MATERIAL, WHEN PRESSURIZED WITH AIR TO 160 MMHG, THE VAPORIZER LOST PRESSURE WITHIN APPROX. 10 SECONDS. CLEANING THE SWITCH CORRECTED THE PROBLEM. 2. THE TAMPER SEAL ON THE BOTTOM CASING SCREW OF THE VAPORIZER WAS MISSING. 3. AT A HANDWHEEL SETTING OF .2 VOL% OUTPUT WAS MEASURED AT 13.5 VOL%, AT A HANDWHEEL SETTING OF 5.0 VOL% OUTPUT WAS MEASURED AT 30.7 VOL%. THE VAPORIZER BYPASS WAS BLOCKED WITH DEPOSITS OF CORROSION PRODUCTS. AFTER CLEANING TO REMOVE THE DEPOSITS, THE VAPORIZER OUTPUT WAS AS FOLLOWS: HANDWHEEL SETTING VOL%: 0, 1, 2, 3, 4, AND 5. MEASURED OUTPUT VOL%: 0, 0.9, 1.77, 2.61, 3.49, AND 4.3.
THE PORT WAS PLACED 7/30/96. THE PT DEVELOPED AN INFECTION AND PORT WAS REMOVED ON 8/8/96. AFTER REMOVAL, A CULTURE WAS DONE OF THE TIP OF THE CATHETER. IT WAS REORTED THAT THE SAME ORGANISM WAS ON THE CATHETER TIP AS HAD INFECTED THE PT.
ON 6/1/96, THE CATHETER HAD BEEN LEAKING. DURING REMOVAL OF THE CATHETER, IT BROKE OFF AND A FRAGMENT EMBOLIZED TO THE PT'S AORTA. THE PT WAS TRANFERRED TO ANOTHER HOSP WHERE CATHETER FRAGMENT WAS REMOVED.
THE CATHETER WAS PLACED 7/19/96. SOMETIME THEREAFTER IT WAS NOTICED THAT THE PT HAD AN INFECTION. THE CATHETER WAS REMOVED AND DISCARDED AT THE FACILITY.
X-TUBE ASSM 17"X16". DEALER CLAIMS X-TUBE BROKE.
HIGH STESS FACTOR AT CENTER AND END OF X-TUBE.  THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ENDOCARDITIS AND VEGETATION WERE REPORTED.
TUBING APPEARS TO BE MFG CORRECTLY AND FUNCTIONS PROPERLY WHEN THE SOLUTION IS ALLOWED TO FLOW USING GRAVITY; HOWEVER, DURING THE PT'S DIPYRIDAMOLE STRESS TEST THE IV SOLUTION DRIPPED DOWN THE SIDE OF THE DRIP CHAMBER INSTEAD OF DOWN THE MIDDLE. THE NURSE WAS FORCED TO WITHDRAW THE DIPYRIDAMOLE FROM THE IV MINIBAG AND ADMINISTER THE DRUG WITH A SYRINGE IN ORDER TO COMPLETE THE PT'S STRESS TEST. NO HARM TO THE PT.
THE LEAD REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON "NORMAL" OR THE ALLEGED "LOW IMPEDANCE". NO FURTHER INFO IS AVAILABLE.
X-TUBE ASSM 18"X16" PNTD.  DEALER CLAIMS X-TUBE IS BROKEN.
CO HAS RECEIVED ONLY VERY LIMITED INFO. THE CAST SAW (00295-200) HAS NOT BEEN YET RETURNED. CO CANNOT BEGIN TO PROPERLY INVESTIGATE UNTIL CO RECEIVE THE PRODUCT.
ON 8/9/96, THE FACILITY NURSE CONTACTED THE MFR AND REPORTED HAVING EXPERIENCES OF "TUBING FRACTURING" WITH THIS DEVICE. THE FACILITY NURSE INFORMED THE MFR THAT THIS TYPE OF INCIDENT HAS OCCURRED APPROX 20 TIMES IN THE LAST 6 MONTHS AND MOSTLY WITH THIS C/N. THE DRUG BEING ADMINISTERED THROUGH THE DEVICE WAS PHENYL ACETIC ACID, WHICH IS AN INVESTIGATIONAL DRUG USED FOR BRAIN TUMORS.
SEVERAL ATTEMPTS WERE MADE TO OBTAIN A SAMPLE OF THE INVESTIGATIONAL DRUG (PHENYL ACETIC ACID) FOR COMPATIBILITY TESTING WITH THE DEVICE; HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENT INVOLVING THIS CATALOG NUMBER AND DID NOT REVEAL ANY TRENDS. BASED ON THE INFO AVAILABLE, THE CUSTOMER'S COMPLAINT OF "TUBING FRACTURING" HAS BEEN CONFIRMED; HOWEVER, THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS INCIDENT.
NURSE FOUND THE SECONDARY MEDICATION WAS RUNNING DIRECTLY INTO THE MAIN BAG DUE TO NONFUNCTIONING BACKCHECK VALVE. NURSE REPLACED IV TUBING AND THE SAME SITUATION RECURRED. A THIRD TUBING OF THE SAME LOT NUMBER WAS USED WHICH FUNCTIONED PROPELRY.
X-TUBE ASSM 18"X18". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS,INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CANNULA HAD HAIRS ON CONTAINER WHEN OPENED.
A POSTERIOR CAPSULE RUPTURED DURING IOL INSERTION AND THE EVENT IS BELIEVED TO BE LENS RELATED. NO OTHER DETAILS HAVE BEEN RECEIVED.
ADD'L INFO HAS BEEN SOUGHT REGARDING THIS INJURY. EVAL OF LENS REVEALED THAT THE RETURNED LENS MET PRODUCT SPECS. NO RESPONSE RECEIVED YET FROM PHYSICIAN. THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIRMENTS AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LAB, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE VALVE WAS IMPLANTED 11/11/95, AND REVISED 8/2/96. FLUID COLLECTION NOTED AROUND THE VALVE. THE PT COMPLAINED OF A MILD HEADACHE. BREAKAGE WAS REPORTED.
WHEN VISUALLY EXAMINED, THE INLET CONNECTOR WAS FOUND TO HAVE BEEN FRACTURED FROM THE VALVE AT THE PROXIMAL CONNECTOR. THE INLET CONNECTOR DAMAGE WAS MOST LIKELY DUE TO MISHANDLING. THE LAB WAS UNABLE TO DETERMINE WHEN THE FRACTURE OCCURRED. ADD'L DATA (EVENT CODES NOT SUPPLIED BY USER FACILITY) PT CODE: 1880. DEVICE CODE: 1260.
THE PORT WAS IMPLANTED APPROX 12/95. DURING AN X-RAY IT WAS NOTICED THAT THE CATHETER HAD BROKEN OFF AND EMBOLIZED. THE PORT WAS REMOVED BUT THE DR WAS UNABLE TO SNARE THE CATHETER FRAGMENT.
NO ELASTIC WEAKNESS WAS FOUND IN THE CATHETER FRAGMENT. THE BROKEN END OF THE TUBING WAS COMPRESSED AND PERMANENTLY FLATTENED INTO A TRUMPET-LIKE OPENING. THE BREAK WAS JAGGED AND ROUGH. UNDER MAGNIFICATION, THE BROKEN SURFACE TEXTURE APPEARED GRANULAR AND DULL AND THE TUBING WAS PERMANENTLY DEFORMED INTO A LONG OVAL SHAPE. THESE ARE SIGNS OF CLAVICLE/FIRST RIB COMPRESSION, WHICH OCCURS DUE TO THE MEDIAL PLACEMENT OF THE CATHETER IN THE SUBCLAVIAN VEIN.
THE INITIAL REPORT SUBMITTED TO FDA SECTION D.6. MODEL# READ BA. A CORRECTION WAS SUBMITTED ON 9/6/1996, AND SECTION D.6. WAS CORRECTED TO READ MODEL# NA. HOWEVER, DURING THE REVIEW OFF THE ABOVE IT WAS NOTED THAT SECTION D.1. BRAND NAME, READ INFUSE-A-PORT SUBCLAVIAN INTRODUCER SET. SECTION D.1. SHOULD HAVE READ INFUSE-A-PORT SUBCLAVIAN INTRODUCER KIT WHICH CORRECTLY MATCHES THE BASELINE REPORT THAT WAS SUBMITTED FOR THIS PRODUCT LINE 9/6/1996 & 4/24/1997. ADDITIONALLY IT WAS NOTED THAT SECTION D.2. READ SUBCLAVIAN INTRODUCER KIT WHICH CORRECTLY MATCHES THE BASELINE REPORT THAT WAS SUBMITTED FOR THIS PRODUCT LINE ON 9/6/1996 & 4/24/1997.
PT CARE TECH WHEELED PT TO SHOWER ROOM IN "SHOWER CHAIR". BEFORE SHE STARTED UP RAMP, TECH HEARD "POP" SOUND, LEANED FORWARD AND TO THE RIGHT OF THE CHAIR, THEN THE CHAIR GAVE WAY PUSHING THE EMPLOYEE BACKWARDS WITH THE PT. THE CHAIR WENT FORWARD, SPILLING PT INTO SHOWER STALL. BACK RT WHEEL CRACKED AND BROKE, BOTH REINFORCEMENT AND PVC PIPE. PT STUCK HEAD ON TILE FLOOR AND C/O HEADACHE SHORTLY AFTER FALL. MULTIPLE BRUISES WITH NEG X-RAYS SUSTAINED.
WHILE REMOVING NEEDLE FROM AN AV DIALYSIS SHUNT THE PLASTIC FLANGE SLID OFF THE NEEDLE LEAVING THE NEEDLE IN THE PT'S SHUNT. THE NEEDLE WAS REMOVED WITH PHYSICIAN INTERVENTION.
RPTR C/O: ANXIETY &/OR DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, DEMENTIA, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, SLOW BRAIN WAVES ON BRAIN MAPPING, PAIN &/OR BURNING SENSATION IN CHEST, ELEVATED CHOLESTEROL OR TRIGLYCERIDES, DISCHARGE ON LOWER EYE LID FOR 2 YRS, HYSTERECTOMY, OVARIAN PROBLEMS, CYST, HYPERSENSITIVITY OR ALLERGIES TO MOLDS, DUST OR POLLEN, CONNECTIVE TISSUE DISEASE, ATYPICAL LUPUS, INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, ASTHMA, FROZEN SHOULDER, UNEXPLAINED RASHES, SUN SENSITIVITY, NUMEROUS MOLES, FRECKLES, ETC, GRANULOMAS OR SILICANOMAS, AND SICCA. ALSO C/O BILATERAL IMPLANT RUPTURES, CAPSULAR CONTRACTURES AND BREAST NUMBNESS. CARDIOLOGY EVALUATION REVEALS A CHRONIC PERICARDIAL EFFUSION SYNDROME POSSIBLY DUE TO A SYSTEMIC ILLNESS POSSIBLY OF RHEUMATOLOGIC ORIGIN. EEG EVALUATION REVEALS DELAYED AEP'S POINT TO A TEMPORAL LOBE PROCESSING PROBLEM AND IS CONSISTENT WITH A DIAGNOSIS OF A PRIMARY DISORDER OF VIGILANCE (ADULT ADD AND INCOMPLETE NARCOLEPTIC SYMPTOMS AND DEPRESSION). THE OVERALL INCREASE IN SLOW WAVE ACTIVITY AND DIMINISHED FAST WAVE ACTIVITY SUGGESTS THE POSSIBILITY OF A METABOLIC DISTURBANCE SUCH AS HYPOTHYROIDISM. AN EARLY SUBCORTICAL DEMENTIA SUCH AS BINSWANGER'S DISEASE CANNOT BE RULED OUT, ALTHOUGH THIS IS NOT A BETA SUGGESTIVE OF ALZHEIMER'S. (*)
THE STAPLER WAS USED DURING A RIGHT COLECTOMY PROCEDURE. THE SURGEON USED THE DEVICE TO CREATE A SIDE TO SIDE ANASTOMOSIS. IT WAS REPORTED ON 8/18/96 THE SURGEON HAD TO REOPERATE DUE TO A DROP IN THE PT'S HEMOGLOBIN. THE SURGEON HAD FOUND THE ANASTOMOSIS HAD BLED AND THERE WERE CLOTS ALONG THE ENTIRE STAPLE LINE. THE SURGEON REPORTEDLY RESECTED THE ORIGINAL ANASTOMOSIS AND HANDSEWED THE NEW ANASTOMOSIS. THE PT HAD RECEIVED FOUR UNITS OF BLOOD, BUT IT WAS UNK WHEN IT WAS RECEIVED. IT WAS REPORTED THE PT WAS DOING FINE AFTER THE REOPERATION.
A1,2,3,4: INFORMATION UNAVAILABLE. D5,6;H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
INFO RECEIVED ON 8/5/96 INDICATES A DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED, DATE AND REASON NOT INDICATED. CO HAS REQUESTED ADDITIONAL INFO.
IN-LINE SETS NOTED TO HAVE SHARDS OF PLASTIC IN IV TUBING. RPTR HAS DOCUMENTED 2 INCIDENTS AND HAS GIVEN THE CO SAMPLES. CONCERN RE: PLASTIC EMBOLI INFUSING INTO PT.
INFO RECEIVED ON 8/5/96 INDICATES A CO DEVICE WAS REMOVED FROM THE PT AND A CO DEVICE IMPLANTED ON 7/15/96, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WAS "NON-FUNCTIONING." ANOTHER WAS IMPLANTED.
DEVICE WAS IMPLANTED DATE NOT INDICATED. DEVICE WAS REMOVED FROM THE PT, REASON AND DATE OF SURGERY NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
CYLINDER HAD OR DAMAGE. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
DURING THE REMOVAL OFTHE SCALP ELECTRODE IMMEDIATELY AFTER DLIVERY, A SCALP LACERATION WAS NOTED. SUBSEQUENTLY, CFS WAS NOTED TO BE LEAKING FROM WOUND. A NEUROSURGICAL CONSULT WAS DONE AND LACERATION SUTURED (2 STITCHES). NO PERMANENT INJURY IS ANTICIPATED.
A CONNECTOR WAS REVISED DUE TO FLUID LOSS.
CONNECTOR PERGORMED WITHIN SPEC. CONNECTOR WAS NOT FUNCTIONALLY TESTED.
PT HAS SX'S SUGGESTIVE OF MILD INTERSTITIAL CYSTITIS, PERIPHERAL NEUROPATHY LT UE > RT UE, ANXIETY, DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, DEMENTIA, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, PAIN AND/OR BURNING SENSATION IN CHEST, INFLAMMATION OF CHEST/RIB CAGE, OCCASIONAL LOW GRADE FEVER (PT NL 97 - NOW 99 F). CHRONIC DIARRHEA AND/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, CHRONIC DISCHARGE, FREQUENT MIGRAINES SEVERE HEADACHES, CHEST PAINS W/NO FINDINGS, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS, INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, PERSISTENT JOINT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY UNDER ARMS LT > RT, LYMPH NODES REMOVED LOCATION(S) ARM PIT, BX DONE, CHRONIC UNEXPLAINED MUSCLE SPASMS, MUSCLE PAIN AND BURNING, MUSCLE ATROPHY, FIBROMYALGIA, UNEXPLAINED RASHES, SUN SENSITIVITY, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICANOMAS, CLUMSINESS/DROPS THINGS, MISJUDGES DISTANCE/RUNS INTO OBJECTS, SICCA (CLINICALLY), NIGHT SWEATS, CHOKING SENSATION, EASY BRUISING AND TINNITUS.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--LEAK IN PUMP TUBING AND ONE CYLINDER. ADD'L SERIAL #: 7799K 001. ADD'L LOT #: 4907K 001.
PUMP HAD A FATIGUE LEAK. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--RESERVOIR. ADD'L SERIAL #: 6027K 020. ADD'L LOT #: 6027K 020.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD A WEAR LEAK. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A FAILED PUMP.
PUMP/TUBING JUNCTION HAD A FATIGUE LEAK. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK.
DURING THE REMOVAL OF THE SCALP ELECTRODE IMMEDIATELY AFTER DELIVERY, A SCALP LACERATION WAS NOTED. SUBSEQUENTLY, CSF WAS NOTED TO BE LEAKING FROM WOUND. A NEUROSURGICAL CONSULT WAS DONE AND LACERATION SUTURED (2 STITCHES). NO PERMANENT INJURY IS ANTICIPATED.
TYPE OF REPORT:I; TYPE OF INJURY: E; NO PERSONS AFFECTED:1; FREQ IN LABELING? N; FREQ GREATER THAN USUAL? U; SEVERITY IN LABELING: N; SEVERITY GREATER THAN USUAL? U. CONTACT PERSON AT FACILITY RETURNED CALL ON 9/4/96, VERIFIED THAT SUSPECT DEVICE WAS DISCARDED AND LOT NO'S ARE EC008. DEVICE WAS NOT REUSED. THERE WAS NO SPINAL DAMAGE. PT HAS NO PERMANENT INJURY AND NO INFECTION. SHE INDICATED THAT IT WAS FELT THAT THE EVENT WAS ATRIBUTABLE TO THE PREMATURE BIRTH. THE IN-STK LOT NO MENTIONED ABOVE WAS THE HOSP IN-STK. THIS LOT NO INVENTORY HAS BEEN EXHAUSTED AT THE MFR SITE. REVIEW OF EC008 DHR REVELAED NOTHING UNUSUAL. USER FACILITY MEDWATCH HAD INDICATED MISAPPLICATION, MISPLACEMENT. HOWEVER, CONTACT INDICATED THAT A LATER REVIEW FOUND NO USER ERROR.
VENTILATION TUBE SURGICALLY PLACED IN EAR 2/15/90, EXTRUDED 9/5/91, LEAVING A HOLE IN TYMPANIC MEMBRANE; LARGE HOLE WHICH NEVER HEALED OVER A GIVEN PERIOD OF TIME, UNDER MEDICAL SUPERVISION. PT NOW HAS MAXIMUM CONDUCTIVE HEARING LOSS AND MUST ALWAYS PROTECT FROM WATER CONTAMINATION. BONES OF HEARING ALSO MISALIGNED DUE TO HOLE.
ON 3/3/94 THE CYLINDERS WERE REVISED. ON 7/31/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--CONNECTION OF RIGHT CYLINDER TO PUMP.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. TUBING HAD A FATIGUE LEAK.
TUBING FOUND TO BE DISCONNECTED FROM THE DEVICE ITSELF. DEVICE PLACED 6/6/95, FOR CHEMO ADMINISTRATION." THE MEDWATCH REPORT DID NOT CONTAIN ANY CONTACT INFO; THEREFORE, THE MFR CONTACTED THE FDA TO OBTAIN ADD'L INFO HOWEVER, THE MFR WAS INFORMED THAT THE FACILITY REQUESTED TO REMAIN ANONYMOUS.
A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS C/N AND DID NOT REVEAL ANY TRENDS. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THIS CAT/LOT NUMBER AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS INCIDENT.
ON 4/8/96 DEVICE WAS IMPLANTED. ON 6/27/96 THE PUMP AND BOTH CYLINDERS WERE REVISED. ON 7/19/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L SERIAL #: BZ739 004. ADD'L LOT #: BZ739 004.
A TANDEM CUFF WAS IMPLANTED DUE TO RECURRING INCONTINENCE. NO COMPONENTS WERE REMOVED OR REPLACED.
THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION-PT DIABETIC. ADD'L SERIAL #: AL196 002. ADD'L LOT #: AL196 002.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITH SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
THE PUMP AND CUFF WERE REMOVED FROM THE PT AND REPLACED DUE TO A HOLE IN THE TUBING.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--PUMP.
PUMP/TUBING JUNCTION HAD A FATIGUE LEAK. CYLINDER HAD OR DAMAGE. CYLINDER HAD OR DAMAGE.
ON 7/24/96, THE PT WAS STARTED ON NASOGASTRIC TUBE FEEDINGS DUE TO POOR INTAKE. AT APPROX 3;30 PM ON 7/24, 400-500 CC OF AN ENTERAL FEEDING SOLUTION WERE HUNG, AND THE PUMP WAS SET TO DELIVER 50 CC/HR. AT APPROX 4:30 PM, THE ALARM SOUNDED INDICATING THE BAG WAS EMPTY, AND ANOTHER 400CC WERE HUNG. AT 5:00 PM, THE PT WAS CHECKED AND 100 CC HAD BEEN DELIVERED. THE RESIDUAL WAS 60 CC AT THAT TIME. TUBE FEEDING WAS STOPPED. THE PT DID NOT SHOW ANY SIGNS OF DISTRESS. THE PUMP WAS CHECKED TO ASSURE THE ROTOR WAS CLEAN AND RUNNING CORRECTLY. AT APPROX 8:00 PM, TUBE FEEDING WAS RESUMED AND ABOUT 500 CC WERE HUNG. BY 9:00 PM, THE PT HAD RECEIVED AN ADD'L BOLUS OF APPROX 300 CC. RESIDUAL WAS CHECKED AND THERE WAS NO RETURN. THE PT DID NOT SHOW ANY SIGNS OF DISTRESS. PLACEMENT OF THE NASOGASTRIC TUBE WAS CHECKED SEVERAL TIMES THROUGH THE EVENING AND WAS FOUND TO BE PLACED PROPERLY. AT APPROX 10:00 PM, THE PT WAS SHOWING SIGNS OF CONGESTION, RESPIRATORY DISTRESS AND HAD AN INCREASED TEMPERATURE (103 RECTALY). THE PT SUBSEQUENTLY EXPIRED AT 10:40 PM. THE IMMEDIATE CAUSE OF DEATH WAS GIVEN AS "CARDIO-RESPIRATORY FAILURE CAUSES UNK."
PUMP DELIVERED WITHIN SPECIFICATIONS. COMPLAINT OF 31 WAS NOT CONFIRMED.
INFO RECEIVED ON 8/5/96 INDICATES A RESERVOIR WAS REMOVED FROM THE PT IN 1994, DAY AND REASON NOT INDICATED. IT IS UNCERTAIN WHICH COMPONENTS WERE REVISED. UNABLE TO OBTAIN ADD'L INFO.
DEVICE WAS IMPLANTED DATE NOT INDICATED. ON 8/5/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A LEAK IN THE CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS TUBING.
DEVICE WAS REMOVED FROM THE PT ON 7/18/96 AND A MALLEABLE DEVICE IMPLANTED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
WHILE THE SURGEON WAS INTRODUCING THE 5MM TROCAR DURING A TUBAL LIGATION, PROTECTIVE SLEEVE DID NOT RETRACT AFTER PENETRATING THE ABDOMEN AND PUNCTURED THE BLADDER.
THE DEVICE DISPLAYED A PREMATURE RETRACTION OF THE TROCAR TIP. THE OPPOSTE OF THE REPORTED MALFUNCTION. CO BELIEVES THIS CONDITION IS RELATED TO EXCESSIVE CYCLING OF THE DEVIDE TROCAR CAUSING WEAR. HOWEVER, THE HOSP HAS REQUESTED THE PRODUCT UNDERGO NO DESTRUCTIVE TESTING, THEREFORE, A THOROUGH EVALUATION COULD NOT BE PERFORMED. THE DEVICE WILL BE RETURNED TO HOSP.
ON 6/27/96 THE CYLINDERS AND PUMP WERE REVISED. ON 8/6/96 THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION.
LUNG CANCER PT UNDERWENT SURGERY 7/9/96 FOR REMOVAL OF LEFT LUNG. TLV39 STAPLES USED TO CREATE ANASTAMOSIS OF LEFT BRONCHUS. PT DISCHARGED AND APPROX 10 DAYS LATER BEGAN EXPERIENCING HEMOPTYSIS. FLEXIBLE BRONCHOSCOPY PERFORMED 7/22/96, REVEALED THAT STAPLES WERE DISRUPTED, RESULTING IN BRONCHO-PLEURAL FISTULA. TL30 STAPLES STOCKED IN HOSP, BUT TLH30 STAPLES NOT STOCKED. SURGEON CHOSE TO USE TLV30.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO MALFUNCTION.
DEVICE WAS REMOVED FROM THE PT BECAUSE THE PT STATES "DEVICE NEVER DID WORK RIGHT FROM THE BEGINNING," PT DISSATISFACTION. ADD'L LOT #: 7494P 003.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A FATIGUE LEAK.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING HAD OR DAMAGE.
DR WAS PERFORMING A PNEUMONECTOMY. HE USED THE TLV30 TO CLOSE THE BRONCHUS AFTER PREVIOUSLY USING IT ON PULMONARY VASCULAR TISSUE. APPROX 7-10 DAYS POSTOPERATIVE THE PT DEVELOPED A BRONCHOPLEURAL FISTULA. THIS WAS TREATED WITH TUBE DRAINGE AND RIB RESECTION. THE PT HAS SUBSEQUENTLY HEALED AND DOING WELL. DR BELIEVES THE STAPLER HE USED WAS NOT THE PROPER STAPLER FOR THE APPLICATION. DR REVIEWED THE X-RAYS AND WILL FORWARD THEM IF IT SHOWS STAPLES FOR CO TO EXAMINE. THE PT IS EXPECTED NOT TO HAVE FURTHER SEQUELAE.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A FATIGUE LEAK.
ON 11/20/95 DEVICE WAS IMPLANTED. ON 6/26/96 A TANDEM CUFF WAS IMPLANTED DUE TO RECURRING INCONTINENCE.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A FLUID LOSS AT RESERVOIR, WOULD NOT INFLATE, AND THE PT DESCRIBES A WHISTLING NOISE.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. CONNECTOR WAS CRACKED OR BROKEN.
F10: 1185 - NOT LABELED.     1096 - NOT LABELED.     1528 - LABELED.
THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE DEVICE WAS RECEIVED IN TWO SEGMENTS. THE SHAFT WAS BROKEN 26.4CM FROM THE DISTAL TIP. THE SHAFT WAS DAMAGED, ELONGATED AND PUNCTURED IN THE AREA OF THE BREAK. A BUBBLE TEST WAS PERFORMED ON THE BALLOON AND NO LEAKS WERE NOTED. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTINUAL EXERTION, AN ELONGATED SHAFT. FOLLOW UP INDICATED CONTINUAL EXERTION WAS APPLIED TO THE CATHETER UPON WITHDRAWAL. CO BELIEVES USER TECHNIQUE, AS WELL AS PT ANATOMY, MAY HAVE CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE.
INFORMATION REQUESTED ON 9/26/96. CONCLUSION STATEMENT: PRODUCT WORN DUE TO FRACTURED FEMORAL COMPONENT. PRODUCT WAS MFR AND SOLD BY ANOTHER CO, THE ASSETS OF WHICH WERE PURCHASED BY THIS CO. TREE CONTACTS TO USER FACILITY WERE MADE AND DOCUMENTED REQUESTED MEDWATCH FORM. INFO WAS NOT RECEIVED.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
DEVICE WAS IMPLANTED ON 1/24/92. THE PUMP WAS REVISED ON 3/1/94. THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--TUBING PULLED AWAY FROM PUMP ON 7/26/96.
CODE 86: EVAL OF EVENT BASED ON HISTORY OF PRODUCT RELATED TO EVENT. PT HISTORY: INSULIN DEPENDANT DIABETIC, SMOKER, PVD WITH CLAUDICATION ON LEFT, POSITIVE PERSANTINE/THALLIUM STRESS TEST, PRE-CATH ASSESSMENT: 2+ PULSES ON RIGHT, DOPPLER PULSES ON LEFT. APPROX 2 WKS PRIOR TO THIS EVENT, PRODUCT WAS USED. HEMOSTASIS WAS ACHIEVED WITH NO COMPLICATIONS. THE EVENT: FASCIOTOMY AND ARTERIOTOMY FOR REMOVAL OF NON-OCCLUSIVE CLOT AT ARTERIAL PUNCTURE SITE. CIRCULATION DID NOT IMPROVE. SECOND FASCIOTOMY AND ARTERIOTOMY TO REMOVE CLOT AT POPLITEAL SITE. PATHOLOGY DESCRIBED CLOT AS AN ORGANIZING EMBOLUS. THERE WAS NO EVIDENCE THAT COLLAGEN WAS INVOLVED.
DEVICE WAS REMOVED FROM THE PT ON 7/30/96, REASON NOT INIDICATED. A MALLEABLE DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO.
AN IMPLANT FAILED DUE TO BONE LOSS AND INFECTION. PT IS REPORTEDLY FINE.
NO OBSEVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS TO BE ACCEPTABLE PER RELEASE CRITERIA.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION-SCROTUM.
THE PT WAS IMPLANTED WITH A SMOOTH SALINE PROSTHESIS. SUBSEQUENTLY, THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION, NECROSIS, SLOUGHING, AND WOUND DEHISCENCE IN HER RIGHT BREAST AND THE PROSTHESIS WAS REMOVED. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
ADD'L INFO TO BE SUBMITTED Y/N? Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PERSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY; MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO.
MEDICS WERE TREATING AN ELDERLY MALE PT WHO WAS EXPERIENCING A CARDIAC ARREST. THE MEDICS DEFIBRILLATED THE PT FOUR TIMES AT 200J AND TWICE AT 360J. THE UNIT AND ELECTRODE APPEARED TO FUNCTION PROPERLY DURING EACH DEFIBRILLATION ATTEMPT. THE PT WAS RESUSCITATED AND TRANSPORTED TO A FACILITY. WHEN THE STAFF REMOVED THE PADS THEY FOUND A REDDENED AREA ON THE PT'S SKIN WHERE THE ELECTRODES HAD BEEN PLACED. THE PT EXPIRED SOME TIME LATER. THERE IS NO INDICATION THAT THE SKIN REDDENING IS RELATED TO THE PT OUTCOME.
PT PRESENTED AT OFFICE WITH BROKEN SCREW AND CROWN.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO WAS UNABLE TO REVIEW THE PRODUCT'S LOT HISTORY SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR'S OFFICE.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO AN UPGRADE.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-17.
DR RETURNED A COPING SCREW ONLY-THE PART REPORTED WAS NOT RETURNED FOR EVALUATION.
WHEEL FELL OFF TCS, WHEN LOWERED, TCS FELL OVER CAUSING PT TO HIT HEAD ON WALL.
FORIEGN REPORTER TO FORWARD ALL INFO REGARDING INCIDENT TO CO.IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. ADD'L INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID-LOSS TUBING FAILURE, CYLINDERS.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A FATIGUE LEAK. TUBING WAS FUNCTIONAL.
IMPLANT SITE 18 FAILED. DR NOT SURE IF IMPLANT FAILED AND CAUSED ABUTMENT TO BREAK OR ABUTMENT BROKE AND CAUSED IMPLANT TO FAIL. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-16.
DR RETURNED A COPING SCREW ONLY - THE PART REPORTED WAS NOT RETURNED FOR EVALUATION.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO ANEURYSM AND RUPTURE OF CYLINDER.
PT WAS SITTING 90 DEGREES FROM NORMAL POSITION AND LUNGED FORWARD AND SAFETY BELT CAME LOOSE FROM CHAIR SECURE KNOBS AND PT FELL ONTO GROUND. PT RECEIVED SUTURES TO FOREHEAD.
UPON INSPECTION CHAIRLIFT WAS FOUND TO GOOD CONDITION, BUT SAFETY BELT HASD SEPARATED INTO TWO SMALLER BELTS. INCORRECT BELTS WERE BEING USED WHICH WERE WORN. PRODUCT HAS BEEN TAKEN OUT OF USE UNTIL APPROPRIATE BELTS HAVE BEEN DELIVERED TO CUSTOMER. CAUSE OF EVENT WAS USER ERROR. CUSTOMER HAS BEEN INSTRUCTED TO REVIEW THE OPERATIONAL AND MAINTAINANCE MANUAL. CORRECT BELTS HAVE BEEN ORDERED.IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N.IS FREQUENCY GREATER FOR THIS EVENT, THAN USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N.IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y.ADDITIONAL INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT.
DR REPORTED THAT AN IMPLANT, WHICH WAS PLACED INTO AN EXTRACTION SITE FAILED TO INTEGRATE. DURING PLACEMENT OF THE HEALING SCREW THE IMPLANT CAME OUT OF THE SITE. PT IS REPORTEDLY FINE.
NO OBSEVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED DUE TO LEAK IN ONE OF THE CYLINDERS.
DEVICE WAS REMOVED FROM THE PT AND REPLACED AS AN UPGRADE TO A 650 MALLEABLE.
THE PT WAS IMPLANTED WITH A SMOOTH SALINE PROSTHESIS ON 6/6/96. SUBSEQUENTLY, THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED DELAYED WOUND HEALING, NECROSIS, AND EXTRUSION OF THE RIGHT BREAST AND REMOVED THE PROSTHESIS ON 6/26/96. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
ADD'L INFO TO BE SUBMITTED Y/N? Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCTR LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVEIRTY ADDRESSED IN PRODUCT LABELING? Y. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PERSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY; MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO.
DEVICE WAS REMOVED FROM THE PT DUE TO A MALFUNCTION AND ANOTHER DEVICE IMPLANTED.
PT WAS BEING RAISED AND PUSHED INTO SITTING POSITION WHEN LEFT SIDE OF YELLOW SLING BECAME DETACHED FROM THE HOIST. PT FELL OUT AND HIT HER HEAD.
THE FOLLOWING IS A CLOSING OUT REPORT BY THE FOREIGN REPORTER. INVESTIGATION: ALL SLINGS WERE CHECKED, AND STAFF WERE INFORMED THAT SLING USAGE SHOULD BE MONITORED, HAVE SPARES AND ENSURE THEY ARE REPLACED APPROPRIATELY. OBSERVATIONS: INVESTIGATOR CHECKED THIS PROCEDURE AND FOUND THAT WITH SUCH WORN SLINGS THEN SLING DETACHMENT WOULD OCCUR. ALSO FOUND THAT THE STAFF HAD NOT HAD AN UPDATE ON THEIR PRODUCT TRAINING SINCE THE HOIST WAS INSTALLED. CONCLUSIONS: THE BLACK CLIPS ON THE SLINGS WERE SO WORN THEY DID NOT CLIP ONTO THE PINS OF THE HANGER BAR. USER ERROR. CORRECTIVE ACTION: REPLACEMENT SLING SENT AND REFERSHER DEMO SCHEDULED.
AN ABUTMENT BROKE IN FUNCTION. PT WENT TO THE PERIODONTIST, HE THREW AWAY PART OF BROKEN ABUTMENT. PT IS REPORTEDLY FINE.
METHOD:(86) PART NOT RETURNED, DR THREW IT AWAY. LOT NUMBER NOT AVAILABLE FROM DR.
AS A PERSON WAS SWINGING USER AROUND FROM THE TUB, USER WIGGLED AND SLID DOWN OFF THE CHAIR, EXCEPT THE SAFETY STRAP STOPPED HER. 911 WAS CALLED TO HELP GET HER OFF THE CHAIR.
UPON INSPECTION OF THIS UNIT WAS FOUND TO BE DIRTY AND HAVE LOTS OF OIL BUILD UP ON THE CHAIR AND WHIRLPOOL. CUSTOMER HAD NOT BEEN FOLOOWING RECOMMENDED PROCEDURES FOR CLEANING AND DESINFECTING THE SYSTEM. CAUSE OF EVENT WAS IMPROPER MAINTANANCE. CUSTOMER HAS BEEN INSTRUCTED TO REVIEW THE OPERATIONAL AND MAINTAINANCE MANUAL.IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N.IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N.IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y.ADDITIONAL INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT.
IN CO'S EVALUATION OF THE RETURNED PRODUCT, CO FOUND THE COMPONENT TO ACTUALLY BE A (CATALOG # 0633, LOT: UNK) UNIVERSAL ABUTMENT INSTEAD OF THE (CATALOG #:0620, LOT: UNK) FIXED ABUTMENT ORIGINALLY REPORTED. NO OBSEVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DR'S OFFICE.
THE PT WAS IMPLANTED WITH SMOOTH SALINE PROSTHESIS ON 6/7/95. SUBSEQUENTLY THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED BREAST PAIN IN BOTH BREAST AND REMOVED THE PROSTHESIS ON 7/18/96. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
ADD'L INFO TO BE SUBMITTED Y/N/ Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENCTLY TAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. 'SUBMISSION OF THIS REPORT BY MENTOS H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARUILY REQUIRED THEREBY MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVIDCE4 MALFUNCTIONED. PURSUANT TO PART 630I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDCENCE OR OTHERWISE USED IN ANYU CIVIL ACTION" SEE PRODUCT EVALUATION.
THE DEVICE WAS REMOVED FROM THE PT AND REPLCED DUE TO FLUID LOSS.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DR'S OFFICE.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION--BUCKLE ON LEFT SIDE.
THE PT WAS IMPLANTED WITH A GEL PROSTHESIS ON 12/15/93. ON 12/17/93 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION IN HER RIGHT BREAST AND THE PROSTHESIS WAS REMOVED. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
ADD'L INFO TO BE SUBMITTED Y/N? Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUSAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING: Y. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. "SUBMISSION OF THIS REPORT VY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY MENTO H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 361I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO.
DEVICE WAS REMOVED FROM THE PT AND AN INFLATABLE DEVICE IMPLANTED DUE TO PT DISSATISFACTION-CONSTANT RIGIDITY.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER DID NOT PASS THE BEND TEST.
DEVICE WAS REMOVED FROM THE PT, DATE AND REASON NOT INDICATED. INFO ACQUIRED ON 8/19/96 INDICATES DATE AS 9/25/95. UNABLE TO OBTAIN ADD'L INFO.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATION. CYLINDER WAS FUNCTIONAL. CYLINDER HAD OR DAMAGE.
THE PT WAS IMPLANTED WITH A PRODUCT ON 6/17/96. ON 8/12/96 IT WAS NOTED THAT THE PT HAD DEVELOPED AN INFECTION IN HER LEFT BREAST AND THE PROSTHESIS WAS REMOVED ON 8/13/96. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
ADD'L INFO TO BE SUBMITTED Y/N? Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUSAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IS THE EVENT OF GREATER SEVERITY THAN STATED IN LAVBELING? N. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3),THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--LEFT CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A FATIGUE AND WEAR LEAK.
EVENT WAS REPORTED AS ENDOCARDITIS. NO FURTHER INFORMATION PROVIDED.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION-RUPTURE, RIGHT CYLINDER MID-PART.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A FATIGUE LEAK.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION.
7/15/96 UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT. 8/5/96 UNDERWENT INCISION AND DRAINAGE OF LEFT KNEE FOLLOWING X-RAY WHICH SHOWED POLY. INSERT DISLOCATION, AND SEROSANGINOUS DRAINAGE. PT ADMITTED FALLING AFTER TKR ON 7/15/96. IDENTICAL INSERT REPLACED DISLOCATED INSERT.
THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO A CAPSULE AROUND RESERVOIR-CYLINDERS WOULD NOT INFLATE.
THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO INCORRECT SIZE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION.
BOTH CYLINDERS HAD FRACTURED WIRE BUNDLES.
THE PUMP WAS REPOSITIONED BECAUSE PT WAS UNABLE TO INFLATE OR DEFLATE THE DEVICE.
THIS EVENT WAS REPORTED AS STENOSIS. NO FURTHER INFORMATION PROVIDED.
A DISSECTION WAS NOTED DURING ATTEMPTS TO POSITION THE GUIDING CATHETER IN THE PT. THE PT WAS SENT TO SURGERY AND IS REPORTED AS DOING OK.
THE INFORMATION IN SECTION F WAS COMPLETED BY THE MFR. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PATIENT STATUS FROM A HOSPITAL OR FIELD CONTACT. EVALUATION SUMMARY: THE RESULTS OF THE INVESTIGATIVE ANALYSIS REVEALED A KINK CLOSE TO THE HUB OF THE DEVICE. THE TIP SHAPE WAS RELAXED, AS TO BE EXPECTED AFTER USE, BUT NO ANOMALIES IN THE TIP WERE NOTED. ENGINEERING CONCLUDED THAT THE PROBABLE CAUSE OF THE CATHETER BECOMING KINKED WAS A RESULT OF ONE OR A COMBINATION OF THE FOLLOWING: OVERTORQUING, TORTUOUS PATIENT ANATOMY, STRAIGHTENING OF THE DISTAL TIP DURING INSERTION INTO THE SHEATH, AND OR ENGAGEMENT INTO THE CORONARY ARTERY OSTIUM WITHOUT PROPER SUPPORT. A REVIEW OF THE MFG DATA FOR THS DEVICE FOUND NO ABERRANCIES. ENGINEERING HAS CONCLUDED THAT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. QUALITY ASSURANCE WILL MONITOR THE DEVICE FOR THE TYPE OF COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPARTMENT.
PUMP PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER HAD OR DAMAGE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
THIS EVENT WAS REPORTED AS ACUTE SHORTNESS OF BREATH, "DEGENERATION" WITH TWO CUPS DAMAGED. NO FURTHER INFORMATION PROVIDED.
IMPLANT WAS PLACED ON 6/3/94. SECOND STAGE SURGERY WAS PERFORMED ON 4/9/96, AT WHICH TIME THE FAILURE WAS IDENTIFIED. THE IMPLANT WAS PLACED IN THE LOWER MANDIBLE, TOOTH POSITION #22. REASON FOR FAILURE WAS DUE TO INFECTION.
INVESTIGATION: IMPLANT FAILURE DUE TO INFECTION. ANALYSIS SUMMARY: NOT ATTRIBUTED TO PRODUCT. CORRECTIVE ACTION: IMPLANT UP TO SPECS. PREVENTATIVE ACTION: NONE.
DURING A STEREOTACTIC BIOPSY PROCEDURE, THE DRILL ASSEMBLY WAS BEING USED WITH A HAND DRILL. THE DRILL BIT BROKE APPROXIMATELY ONE INCH FROM THE TIP. THE PHYSICIAN HAD TO MAKE A LARGER INCISION TO RETRIEVE THE TIP WHICH WAS LODGED IN THE SCALP IN SOFT TISSUE.
EVALUATION SUMMARY: THE DA(2.7) WAS RETURNED AND UPON EVALUATION THE DRILL WAS FRACTURED JUST AFTER THE START OF THE FLUTES ON THE DRILL. IF THE DRILL WERE TO BIND, FOR EXAMPLE DUE TO EXCESSIVE SPEED, THERE IS POTENTIAL FOR THE DRILL BASED ON THE BINDING TO BREAK. THE POINT WHERE THE FRACTURE OCCURRED IS AT THE POINT OF REDUCTION IN THE CROSS SECTION OF THE DRILL. THE POINT OF REDUCTION IN THE CROSS SECTION OF THE DRILL SHAFT IS THE POINT OF CONCENTRATION OF STRESS FORCES. THEREFORE IT IS NOT BELIEVED THAT THERE WAS A FLAW IN THE MATERIAL CAUSING THE DRILL TO BREAK. CO BELIEVES THAT THIS EVENT OCCURRED DUE TO EXCESSIVE FORCE ON THE DRILL BECAUSE THE DRILL BOUND IN THE SKULL OR DUE TO EXCESSIVE LATERAL FORCE PRESSURE PLACED ON THE DRILL. IN ADDITION THERE ARE VISIBLE, CONSISTENT SERRATION ON THE EDGE OF THE FLUTE NEAR THE TIP OF THE DRILL. A WEAKENING OF THE DRILL IN THE FLUTE AREA WOULD CONTRIBUTE TO A FRACTURE IF THE DRILL WERE TO BIND UP DURING USE.
2200 = TIREDNESS. 2203 = VALVE DETERIORATION. H3: EXAMINATION OF THE VALVE IN CO'S LABORATORY REVEALED CALCIFICATION WITHIN THE ATTACHMENT SITE OF EACH CUSP WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA AND MULTIPLE DISRUPTIONS. HOST TISSUE OVERGROWTH FUSED EACH ATTACHMENT SITE AND THE COMMISSURE BETWEEN THE LEFT AND NONCORONARY CUSP CONTRIBUTING TO STENOSIS OF THE VALVE AND FURTHER DISRUPTIONS. CALCIFICATION AND HOST TISSUE OVERGROWTH RESULTED IN DETACHMENT OF EACH LEAFLET AND INCOMPLETE COAPTATION. MECHANICAL DISRUPTIONS WERE NOTED IN THE LEFT-CORONARY CUSP AND APPEARED ARTIFACTUAL OF EXPLANT. X-RAY ANALYSIS REVEALED CALCIFICATION WITHIN THE AORTIC WALL AND BELLY OF EACH CUSP ESPECIALLY CONCENTRATED AT EACH ATTACHMENT SITE. STENT DISTORTION WAS NOTED WHICH APPEARED ARTIFACTUAL OF THE EXPLANT PROCEDURE. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DUE TO CALCIFICATION. THESE FINDINGS WOULD ACCOUNT FOR THESE SYMPTOMS NOTED CLINICALLY. H6: 86 = X-RAY
REPORTED AS DEVICE EXPLANTED DUE TO "VALVE DETERIORATION AND WORSENING TIREDNESS OVER LAST 3 YEARS". NO FURTHER INFORMATION PROVIDED.
PT WAS 40+ WEEKS IN ACTIVE LABOR. UPON INSERTION OF INTRAN PLUS, THERE WAS A DECREASE IN B/P INTO THE 50'S. THERE WAS A LARGE AMOUNT OF VAGINAL BLEEDING. AN EMERGENCY C-SECTION WAS PERFORMED WITH FETAL DEMISE.
ATTEMPTS BY UTAH MEDICAL PRODUCTS, INC., TO OBTAIN ADDITIONAL INFO AND/OR ARRANGE ON-SITE PRODUCT EVALUATION HAVE BEEN UNSUCCESSFUL.
INFO RECEIVED ON 8/1/96 INDICATES DEVICE WAS REMOVED FROM PT AND REPLACED ON 12/10/93, REASON NOT INDICATED. UNABLE TO OBTAIN ADD'L INFO.
ON 5/17/96, A ST10X3.75 WAS PLACED IN THE PT IN TOOTH POSITION #9. WHEN THE PT RETURNED FOR POST-OP VISIT, THE IMPLANT WAS FOUND EXPOSED AND IT WAS LOOSE IN THE BONE. IMPLANT WAS REMOVED AND REPLACED WITH A ST13X3.75MM IMPLANT. A BONE GRAFT PROCEDURE WAS PERFORMED.
DR. HAS BEEN FAXED THIS REPORT. NO FURTHER INFO AT THIS TIME. INVESTIGATION: NO EXPLANATION OF FAILURE. ANALYSIS SUMMARY: CASE UNKNOWN. CORRECTIVE ACTION: NONE.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO IMPROPER SIZE-SST DEFORMITY.
THIS EVENT WAS REPORTED AS "DEGENERATION", AND REGURGITATION. NO FURTHER INFORMATION PROVIDED.
H3: EXAMINATION OF THE DEVICE IN CO'S LABORATORY REVEALED SEVERAL DELAMINATION DISRUPTIONS IN THE FREE MARGIN AND BELLY OF EACH CUSP SUCH AS WOULD OCCUR DURING SUTURE FOR THESE DISRUPTIONS, THE EXACT CAUSE IS UNCERTAIN. HOST TISSUE OVERGROWTH APPEARED TO HAVE ENCROACHED ONTO EACH CUSP WHICH WOULD HAVE RESOLTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA,   FURTHER DISRUPTIONS IN THE HINGE AREA OF EACH LEAFLET AND INCOMPLETE COAPTATION. THE MAJORITY OF THE HOST TISSUE OVERGROWTH HAD BEEN REMOVED PRIOR TO RECEIPT. MECHANICAL INJURIES WERE NOTED IN EACH CUSP WHICH APPEARED ARTIFACTUAL OF EXPLANT. X-RAY ANALYSIS REVEALED MINOR FOCI OF CALCIFICATION WITHIN THE AORTIC WALL OF THE RIGHT-CORONARY CUSP. ADDITIONALLY, STENT DISTORTION WAS NOTED WHICH APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DUE TO DISRUPTIONS OF AN INDETERMINABLE SOURCE. THESE FINDINGS WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY. H6: 86 = X-RAY
REPORTED AS DEVICE EXPLANTED DUE TO WORSENING AORTIC VALVE REGURGITATION. NO FURTHER INFORMATION PROVIDED.
THIS EVENT WAS REPORTED AS A PROPHYLACTIC REPLACEMENT AS PT REQUIRED MITRAL VALVE REPLACMENT. NO FURTHER INFORMATION PROVIDED.
INFORMATION RECEIVED ON 10/15/96 INDICATES THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT, DUE TO FLUID LOSS, AND REPLACED.
DOCTOR WAS SENT INVESTIGATION FORM.THE INVESTIGATIVE WORKSHEET STATED THAT TWO 15MML 3.75 MMD IMPLANTS WERE PLACED IN THE #21 AND #28 AREAS AND A 13MML 3.25MMD IMPLANT WAS PLACED IN THE #24 AREA OF THE MANDIBLE ON 6-3-96. THE IMPLANTS FAILED TO OSSEOINTEGRATE AND WERE REMOVED ON 7-31-96. THE PERIAPICAL RADIOGRAPHS DATED 7-29-96 SHOWED THE TWO 15MML 3.75MMD IMPLANTS IN THE #21 AND #28 AREAS AND AA 13MML 3.25MMD IMPLANT IN THE #24 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DEWNTAL IMPLANTS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THIS EVENT WAS REPORTED AS "DEGENERATION". NO FURTHER INFORMATION PROVIDED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-HOLE IN PROSTHESIS.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPEICIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK.
THE IMPLANT WAS PLACED IN PT ON 8/14/95 IN TOOTH POSITION #16. THE PT WAS SEEN IN DRS OFFICE ON 6/10/96. UPON EXAMINATION, THE DR FOUND THAT THE ABUTMENT WAS LOOSE. X-RAYS WERE TAKEN AND WAS NOTICED THAT BONE LOSS HAD OCCURRED AROUND THE IMPLANT. THEREFORE, IMPLANT WAS REMOVED. UPON REMOVAL OF THE IMPLANT, THE CHRONICALLY INFLAMED TISSUE SURROUNDING THE IMPLANT WAS DEBRIDED. A BONE GRAFT PROCEDURE WAS ALSO DONE FOR THIS PT.
MED WATCH HAS BEEN FAXED TO DR. NO FURTHER INFO AT THIS TIME. INVESTIGATION: INFECTION, CHRONIC INFLAMATION AROUND IMPLANT. ANALYSIS SUMMARY: NOT ATTRIBUTED TO PRODUCT. CORRECTIVE ACTION: IMPLANT UP TO SPECS.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO PUMP MALFUNCTION-PT COMPLAINED OF POOR ERECTION QUALITY.
THIS REPORT HAS BEEN FAXED TO DR. NO FURTHER INFO AT THIS TIME. INVESTIGATION: IMPLANT UP TO OUR SPECS. ANALYSIS SUMMARY: CAUSE UNKNOWN. CORRECTIVE ACTION: NONE.
FIXTURE INITIALLY WAS PARTIALLY INTEGRATED. I PLACED AN OSSEOUS GRAFT AND MEMBRANE IN ATTEMPT TO SAVE - HOWEVER EVENTUALLY FAILED.
CYLINDER HAD OR DAMAGE. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL. RESERVOIR TUBE WAS PULLED OUT. PUMP CYCLES TO INFLATE NOT WITHIN SPECS.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO MALFUNCTION.
TUBING WAS FUNCTIONAL. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK.
THE INVESTIGATIVE WORKSHEET STATED THAT TWO 15MML 3.75MMD IMPLANTS WERE PLACED IN THE #21 AND #28 AREAS AND A 13MML 3.25MMD IMPLANT WAS PLACED IN THE #24 AREA OF THE MANDIBLE ON 6/3/96. THE IMPLANTS FAILED TO OSSEOINTEGRATE AND WERE REMOVED ON 7/31/9. THE PERIAPICAL RADIOGRAPHS DATED 7/29/96 SHOWED THE TWO 15MML 3.75MMD IMPLANTS IN THE #21 AND #28 AREAS AND A 13MML 3.25MMD IMPLANT IN THE #24 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FINDS NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLNATS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOUCS OF THIS INVESTIGATION.
DR. HAS BEEN FAXED THIS FORM FOR MORE INFO. NO FURTHER INFO AT THIS TIME. INVESTIGATION: IMPLANT UP TO OUR SPEC. ANALYSIS SUMMARY: CAUSE UNKNOWN. CORRECTIVE ACTION: NONE.
ON 5/23/90 DEVICE WAS IMPLANTED. ON 5/15/96 THE RESERVOIR WAS REVISED. ON 7/18/96 THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO EROSION.
WITHOUT INFO A THOROUGH INVESTIGATION CANNOT BE COMPLETED. CO IS MAKING A SECOND REQUEST FOR THE ADDITIONAL INFO.
MEDWATCH FORM HAS BEEN FAXED TO DR. NO FURTHER INFO AT THIS TIME. INVESTIGATION IMPLANT UP TO CO'S SPECS. ANALYSIS SUMMARY: CAUSE UNKNOWN. CORRECTIVE ACTION: NONE. PREVENATATIVE ACTION: NONE.
AS PER DR., AT THE 2ND STAGE APPOINTMENT, THE IMPLANT WAS NOTED TO BE LOOSE, IT WAS THEN REMOVED.
THE PT WAS CONSIDERED TO BE A POOR SURGICAL CANDIDATE, SO THE PHYSICIAN OPTED TO ATTEMPT STENT PLACEMENT. ONE CORONARY STENT WAS SUCCESSFULLY DELIVERED TO THE TARGET LESION SITE IN THE PT'S SAPHENOUS VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY. THE DELIVERY SYSTEM WAS WITHDRAWN AND A SECOND STENT WITH DELIVERY SYSTEM WAS ADVANCED TO A LESION IN THE OSTIUM OF THE SAME VESSEL. THE PROTECTIVE SHEATH WAS RETRACTED AND THE BALLOON INFLATED TO 6 ATMS, DEFLATED AND THEN INFLATED TO 8 ATMS. THE BALLOON BURST AND BECAME ENTANGLED IN THE STENT. THE PHYSICIAN WAS UNABLE TO WITHDRAW THE STENT OR BALLOON FROM THE PT. THE DEVICE WAS CUT AND THE BALLOON AND STENT REMAIN IN THE PT'S VEIN GRAFT WHICH WAS ALLOWED TO CLOT OFF. THE PT WAS PLACED ON AN INTRA-AORTIC BALLOON PUMP UNTIL STABLE. THERE WERE NO CLINICAL SEQUEALE REPORTED RELATIVE TO THE EVENT.
STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN NATIVE CORONARY PROCEDURES ONLY.
STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY. UPON THE INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON WOULD NOT INFLATE AND THE STENT EMBOLIZED. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATIONS AND AN ADD'L BALLOON CATHETER WAS USED TO RETRIEVE THE STENT. A SECOND CORONARY STENT WITH DELIVERY SYSTEM WAS USED TO SUCCESSFULLY PLACE A STENT AT THE TARGET LESION SITE. THERE WERE NO CLICNICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
PRODUCT EVALUATION REVEALED THAT INABILITY TO INFLATE THE BALLOON WAS DUE TO OVER-TIGHTENING OF THE TUOHY-BORST VALVE WHICH CAUSED NARROWING OF THE BALLOON TUBING.
DEVICE BROKE IN ARTHROSCOPIC SHOULDER SURGERY. SURGERY WAS DELAYED TO CONVERT TO OPEN SHOULDER PROCEDURE TO REMOVE PIECES.
INVESTIGATION DETERMINED THAT DEVICE BROKE. BROKEN PIECE WAS 1 1/2 INCHES LONG AND PARTIALLY CRIMPED. NO OTHER COMPLAINTS RECEIVED ON THIS LOT. NO CONCLUSION AS TO CAUSE HAS BEEN DETERMINED. COMPANY DISCLAIMER: "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT."
DENTAL IMPLANT FAILED. DOCTOR WAS SENT INVESTIGATION FORM.
THIS EVENT WAS REPORTED AS "RING BECAME DISRUPTED". NO FURTHER INFORMATION PROVIDED.
FAILED VALVE. "THE OLD PORSTHETIC VALVE WAS THEN INSPECTED AND IT WAS FOUND TO BE VERY MARKEDLY DAMAGED WITH THE LOSS OF ONE WHOLE CUP. THE REST OF THE VALVE HAD TORN LEAFLETS."
HE HAD NO REAL CARDIAC CAUSE FOR THIS EVENT. NATURALLY BEING ANTI COAGULATED AS HE WAS IN THE PERI-OPERATIVE PERIOD EXACERBATED HIS BLEEDING PROBLEMS BUT THIS CANNOT BE ATTRIBUTED TO THE DEVICE WHICH WAS FUNCTIONALLY NORMALLY." THIS CAUSE OF EVENTS WAS RECEIVED ON 9/9/96.
DEVICE WAS USED DURING AN UNSPECIFIED GYNECOLOGICAL PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE DEVICE COULD NOT BE OPENED AFTER APPLICATION. THE DEVICE WAS RESECTED AND THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER DEVICE. THE HOSP HAS REPORTED PT STATUS AS SATISFACTORY.
DEVICE DISPLAYED DISTORTION TO THE CARTRIDGE FRAME AREA THAT PREVENTED IT FROM OPENING. THIS DAMAGE IS THE RESULT OF THE USER FORCING THE DEVICE TO CLOSE ON TISSUE OF EXCESSIVE THICKNESS. AS IS NOTED IN THE DEVICE INFORMAL BOOKLET THAT ACCOMPANIES EACH DEVICE SHIPMENT; IF THE POSITIONING LEVER DOES NOT CLOSE COMFORTABLY, TISSUE IS TO THICK AND USE OF THE INSTRUMENT IS CONTRAINDICATED.
SEVERE MITRAL REGURGITATION AND SEVERE MITRAL VALVE ENDOCARDITIS WERE REPORTED.
THE PT EXTUBATED HIMSELF WHILE CONNECTED TO THE VENTILATOR. THE CLINICIAN RECONNECTED THE PT AND NOTED AN EXCESSIVE AMOUNT OF WATER IN THE PT CIRCUIT. THE VENTILATOR BEGAN TO DELIVER A CONTINUOUS RUSH OF GAS. THE ALARM SYSTEM WAS FUNCTIONAL. BUT THE HOSPITAL DID NOT NOTICE WHICH ALARMS WERE SOUNDING.
THE DEVICE WAS EVALUATED BY CO AND THE PROBLEM WAS RELATED TO THE PRESSURE TRANSDUCERS.
HE HAD NO REAL CARDIAC CAUSE FOR THIS EVENT. NATURALLY BEING ANTI COAGULATED AS HE WASIN THE PERI-OPERATIVE PERIOD EXACERBATED HIS BLEEDING PROBLEM BUT THIS CANNOT BE ATTRIBUTED TO THE DEVICE WHICH WAS FUNCTIONING NORMALLY." THIS CAUSE OF EVENT WAS RECEIVED ON 9/9/96.
F8: UNK; F11: UNK; F10: DEVICE CODE: 1077, 1628; H3: EXAMINATION OF THE VALVE IN CO'S LABORATORY REVEALED CALCIFICATION AT EACH ATTACHMENT SITE WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS, INCLUDING DETACHMENT OF EACH CUSP, AS WELL AS INCOMPLETE COAPTATION. HOST TISSUE OVERGROWTH FUSED EACH COMMISSURE AND ENCROACHED ONTO EACH CUSP, CONTRIBUTING TO STENOSIS OF THE VALVE. THE MAJORITY OF EACH LEAFLET WAS MISSING WITH CLEAN-EDGES ON THE REMNANT TISSUE INDICATIVE OF HISTOLOGICAL SECTIONING. PRIOR TO RECEIPT X-RAY ANALYSIS REVEALED CALCIFICATION WITH THE AORTIC WALL AND BELLY OF EACH CUSP. STENT DISTORTION WAS  ALSO NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DETERMINED TO BE DUE TO CALCIFICATION. THESE FINDINGS WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY. H6: 86 = X-RAY ANALYSIS.
REPORTING FACILITY DECLINED AN OFFER OF DEVICE SERVICE FROM CO AND WILL RETIRE THE DEVICE FROM USE. SUBSEQUENT TO THE SUBMISSION ON THE INITIAL MEDWATCH REPORT FOR THIS EVENT THE REPORTER STATED THAT THE PT OUTCOME WAS NOT THE RESULT OF DEVICE OPERATION, BASED UPON A LACK OF PT VIABILITY. THE REPORT TYPE, THEREFORE, HAS BEEN CHANGED FROM ADVERSE EVENT TO PRODUCT PROBLEM. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
WHEN ANALYZE WAS PRESSED IN PT USE, THE DEVICE REVERTED BACK TO PUSH TO ANALYZE PROMPT.
INSUFFICIENCY, DEGENERATION, FIBROSIS, CALCIFICATION AND NODULES WERE REPORTED.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN 5 IMPLANTS WERE PLACED DURING A ROUTINE PROCEDURE IN CLASS III BONE. THE CLINICIAN REPORTS THAT THE IMPLANT IN SITE NUMBER 26 DID NOT INTEGRATE AND WAS REMOVED APPROX 2 MONTHS POST-OPERATIVEELY. ACCORDING TO THE CLINICIAN THE REMAINING 4 IMPLANTS ARE STABLE.
MFR DEVICE EVALUATION TO FOLLOW AT A LATER DATE. ADD'L INFO REPORT WILL BE FLED AT THAT TIME.
WITHOUT ADDITIONAL INFO A THOROUGH INVESTIGATION CANNOT BE COMPLETED. CO IS MAKING A SECOND REQUEST FOR THE ADDITIONAL INFO.
BIVENTRICULAR HEART FAILURE, STENOSIS, AND INSUFFICIENCY ARE REPORTED.
DURING A PTA PROCEDURE, THE BALLOON DETACHED FROM THE SHAFT OF THE CATHETER. PORTIONS OF THE DETACHED BALLOON WERE RETRIEVED WITH A SURGICAL PLIERS. THE BALLOON MARKER REMAINS IN THE PT'S FEMORAL ARTERY. PT STATUS IS LISTED AS "OK."
RETURNED PRODUCT ANALYSIS REVEALED A CIRCUMFERENCIAL TEAR OF THE BALLOON MATERIAL. THE DISTAL PORTION OF THE BALLOON AND THE SHAFT WERE NOT RETURNED FOR ANALYSIS. EXAMINATION OF THE RETURNED COMPONENTS DID NOT REVEAL ANY MATERIAL OR MFG DEFICIENCIES.
THE INVESTIGATIVE WORKSHEET STATED THAT A MML 3.75MMD IMPLANT WAS PLACED IN THE #19 AREA AND AN 8MML 3.75MMD IMPLANT WAS PLACED IN THE #20 AREA OF RHE MANDIBLE ON 5/3/96. BOTH IMPLANTS FAILED TO OSSEOINTEGRATE AND WERE REMOVED ON 5/30/96. THE TWO IMPLANTS THAT WERE INCLUDED WITH THIS REPORT WERE EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANTS WERE FREE FROM ANY DEFECT AND THAT THEY MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MANUFACTURER'S SPECIFICATIONS. THE PERIAPICAL RADIOGRAPH DATED 5/7/96 SHOWED A 10MML 3.75MMD IN THE 19 AREA AND AN 8MML 3.7MMD IMPLANT IN THE #20 AREA OF THE MANDIBLE. AFTER STUDING THE X-RAY AND REVIEWING REPORT, CO FINDS NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANTS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
DOCTOR WAS SENT INVESTIGATION FORM, THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.75MMD IMPLANT WAS PLACED IN THE #20 AREA OF THE MANDIBLE ON 2/22/96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 8/5/96. THE PANORAMIC RADIOGRAPH DATED 2/22/96 SHOWED A 10MML 3.75MMD IMPLANT IN THE #20 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOUCUS OF THIS INVESTIGATION.
#3: EXAMINATION OF THE VALVE IN CO LABORATORY REVEALED ONE V-SHAPED, DELAMINATED DISRUPTION IN THE NODE AND ONE OVAL, DELAMINATED DISRUPTION IN THE BELLY OF THE LEFT-CORONARY CUSP WHICH EXHIBITED EVIDENCE OF ABRASION, SUCH AS WOULD OCCUR IN SUTURE ABRASION. HOWEVER, IN THE ABSENCE OF EVIDENCE FOR THIS ABRASION, THE SOURCE WAS INDETERMINABLE. THESE DISRUPTIONS RESULTED IN INCOMPLETE COAPTATION. HOST TISSUE OVERGROWTH EXCROACHED ONTO EACH LEAFLET RESULTING IN STENOSIS OF THE EFFECTIVE ORIFICE AREA. X-RAY ANALYSIS REVEALED NO APPARENT CALCIFICATION. SLIGHT DISTORTION OF THE STENT WAS NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO LEAFLET DISRUPTION DUE TO AN INDETERMINABLE CAUSE. THESE FINDING WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY.H6: 86= X-RAY ANALYSIS.
DOCTOR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 4.7MMD IMPLANT WAS PLACED IN THE #4 AREA OF THE MAXILLA ON 3-19-96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 8-11-96. THE PERIAPICAL RADIOGRAPH DATED 8-1-96 SHOWED A 10MML 4.7MMD IMPLANT IN THE #4 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAY AND REVIEWING, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
DOCTOR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 4.7MMD IMPLANT WAS PLACED IN TEH #19 AREA OF THE MANDIBLE ON 1/22/96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 8/6/96. THE PERIAPICAL RADIOGRAPH DATED 7/22/96 SHOWED A 10MML 4.7 MMD IMPLANT IN THE #19 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN TEH DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
H6: 86= X-RAY. 79= WRONG SIZE SELECTED, REPLACED WITH SMALLER SIZED DEVICE.
THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.75MMD IMPLANT WAS PLACED IN THE #21 AREA OF THE MANDIBLE ON 1/17/96. THE IMPLANT FAILED TO MAINTAINN OSSEOINTEGRATE AND WAS REMOVED ON 7/23/96. THE 10MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY OUR ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MANUFACTURE'S SPECIFICATIONS. THE PANORAMIC RADIOGRAPH DATED 4/23/95 SHOWD A 10MML 3.75MMD IMPLANT IN THE #21 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FINDS APPARENT FACTORS THAT WOULD AHVE PREVENTED THIS DENTAL IMPLANT FROM MAINTIAING OSSEOINTEGRATION. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOUCS OF THIS INVESTIGATION.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. ACCORDING TO THE CLINICIAN 6 IMPLANTS WERE PLACED IN THE MANDIBLE DURING A ROUTINE PROCEDURE IN CLASS II BONE. THE CLINICIAN REPORTS THAT THE IMPLANTS IN SITE NUMBERS 20, 21, AND 29 DID NOT INTEGRATE AND WERE REMOVED APPROX. 1 MONTH POST-OPERATIVELY. ACCORDING TO THE CLINICIAN THE REMAINING 3 IMPLANTS STABLE.
THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.75MMD IMPLANT WAS PLACED IN THE #18 AREA OF THE MANDIBLE TO SUPPORT A SINGLE CROWN. THE IMPLANT WAS IN FUNCTION FOR LESS THAN TWO YEARS BEFORE IT BROKE AND HAD TO BE REMOVED. THE 10MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS STERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MANUFACTURER'S SPECIFICATIONS. THE PERIAPICAL RADIOGRAPH DATED 4/6/94 SHOWED A 10MML 3.75MMD IMPLANT IN THE #18 AREA OF THE MANDIBEL SUPPORTING A HEX-LOCK ABUTMENT (HLA3F). THE PERIAPICAL RADIOGRAPH DATED 8/1/96 SHOWED THE 10MML IN THE #18 AREA WITH WHAT APPEARED TO BE A VERTICAL SPLIT AT THE COLLAR. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FINDS THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE IMPLANT THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT SI RECOMMENDED TO REPLACE THE BROKEN IMPLANT WITH A WIDER ONE FOR THE ADDITIONAL SUPPORT.
WHILE TREATING A VESSEL WITH A 2.0 MM CO BURR, A PERFORATION OCCURRED. THE PT DEVELOPED CARDIAC TAMPONADE, BEGAN TO HAVE PROBLEMS WITH CLOTTING, AND SUBSEQUENTLY DIED.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13MML 3.75MMD IMPLANT WAS PLACED IN THE #6 AREA OF THE MAXILLA ON 11/1/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 5/17/96. ON 12/1/95, A 16MML 3.75MMD IMPLANT WAS PLACED IN THE #27 AREA OF THE MANDIBLE. IT ALSO FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 6/10/96. THE TWO IMPLANTS THAT WERE INCLUDED WITH THIS REPORT WERE EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANTS WERE FREE FROM ANY DEFECT AND THAT THEY MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MANUFACTUTER'S SPECIFICATIONS. THE PANORAMIC RADIOGRAPH DATED 9/21/895 SHOWED A FULLY EDENTULOUS MAXILLA AND MANDIBLE. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FINDS APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANTS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE COMPLAINANT IS AN INSULIN DEPENDENT DIABETIC WHO ADJUSTS INSULIN DOSAGE BASED ON METER READINGS. HE STATES THAT BECAUSE OF THE LOWER READINGS HE REDUCED THE AMOUNT OF INSULIN. THE REDUCED AMOUNT OF INSULIN RESULTED IN A HYPOGLYCEMIC STATE. INVESTIGATION INTO THIS MATTER DISCOVERED THAT HE WAS USING OFF BRAND REAGENT TEST STRIPS. PRODUCT LABELING INDICATES THAT ONLY CO TEST STRIPS TO BE USED. HOWEVER, THE CUSTOMER INDICATED THAT HE WAS HAVING PROBLEMS WITH THE SYSTEM SINCE 6/95. THIS INCLUDED LOW BLOOD SUGAR RESULTS. DURING A COMPARISON THE CO METER GAVE A RESULT OF 42 ML/DL WHILE A LABORATORY METHOD GAVE AN 800 MG/DL. THE TIME DIFFERENCE IS UNKNOWN. WHILE IN THE HOSPITAL FOR THIS EVENT, THE CUSTOMER EXPERIENCED A STROKE. ACCORDING TO HIS WIFE THE STROKE WAS POSSIBLY CAUSED BY MEDICATION "CARBOLOBIDIO" TAKEN FOR HIS PARKINSON'S DISEASE. A REVIEW OF THE OPERATION OF THE SYSTEM WAS MADE. THE CUSTOMER CONSISTENTLY RECEIVED OUT OF RANGE CONTROL RESULTS FOR BOTH OLDER (STILL WITHIN EXPIRATION AGE) AND FRESH REAGENT STRIPS. A REQUEST WAS MADE TO RETURN THE SYSTEM FOR EVAL.
THE INSTRUMENT, REAGENT STRIPS 100 LOT NUMBER C187124 EXP DATE 12/96, REGENT STRIPS 25 LOT NUMBER 1750105 EXP DATE 10/97, A880016 EXP DATE 1/98, AND NORMAL CONTROL LOT NUMBER 0952 EXP DATE 1/97 WERE RETURNED FOR EVAL. PERFORMANCE TESTING GAVE UNACCEPTABLY LOW NORMAL CONTROL AND BLOOD RESULTS WITH LOT NUMBER C187124. HOWEVER, LOTS A750105 AND A880016 GAVE ACCEPTABLE PERFORMANCE WITH THE BOTH NORMAL CONTROL AND BLOOD. PERFORMANCE CHARACTERISTICS AS THESE USUALLY INDICATE THAT THE PRODUCT WAS MISHANDLED BY THE CUSTOMER. THIS CAN INCLUDE EXCESSIVE EXPOSURE TO HEAT AND/OR HUMIDITY. THE COMPLAINT IS CONSIDERED CLOSED.
DURING A PTCA PROCEDURE, THE BALLOON RUPTURED. AS THE BALLOON CATHETER WAS BEING REMOVED, THE TIP OF THE GUIDE WIRE FRACTURED. ALL PIECES WERE RETREIVED. PT STATUS IS LISTED AS "OK." REPORT #2125152-1996-00001.
RETURNED PRODUCT ANALYSIS REVEALED A CIRCUMFERENTIAL TEAR IN THE BALLOON MATERIAL. THE INNER WIRE LUMEN WAS STRETCHED AND KINKED AT THE SITE OF THE TEAR. THE GUIDE WIRE, RETURNED WITH THE BALLOON CATHETER, WAS KINKED AT NUMEROUS SITES. THE DISTAL 2.5 CM OF THE WIRE WAWS NOT RETURNED FOR ANALYSIS. NO MATERIAL OR MFG DEFICIENCIES WERE NOTED.
THE INVESTIGATIVE WORKSHEET STATED THAT A 13MML 3.75MMD IMPLANT WAS PLACED IN THE #6 AREA OF THE MAXIALLA ON 11/1/95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 5/17/96. ON 12/1/95, A 16MML 3.75MMD IMPLANT WAS PLACED IN THE #27 AREA OF THE MANDIBLE. IT ALSO FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 6/10/96. THE TWO IMPLANTS THAT WERE INCLUDED WITH THIS REPORT WERE EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLNATS WERE FREE FROM ANY DEFECT AND THAT THEY MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MANUFACTUTER'S SPECIFICATIONS. THE PANORAMIC RADIOGRAPH DATED 9/21/95 SHOWED A FULLY EDENTULOUS MAXILLA AND MANDIBLE. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FINDS NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANTS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
DURING A DIALYSIS TREATMENT, THERE WAS EXCESS WEIGHT REMOVAL, WHICH RESULTED IN A DROP IN PT'S BLOOD PRESSURE. PT WAS ADMINISTERED 2600ML OF SALINE.
CLINIC STAFF FOUND THAT THE NEGATIVE PRESSURE WAS READING -80 TO -90 MMHG. AT 0 MMHG. RECALIBRATED THE NEGATIVE PRESSURE AND REPLACED LEAKING UFR TUBE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE AFFECTED COMPONENTS WERE NOT RETURNED FOR EVALUATION AND WITHOUT THE AFFECTED COMPONENTS, EVALUATION CANNOT TAKE PLACE. THE NEGATIVE PRESSURE CONTROLLER WAS NOT RETURNED SINCE IT WAS RECALIBRATED IN THE FIELD. THE UFR METER WAS DISCARDED BY THE CUSTOMER. ATTEMPTS BY THE MFR TO CONTACT THE FACILITY FOR FURTHER INFO HAVE NOT BEEN SUCCESSFUL. THE LEAKING UFR METER MOST LIKELY CAUSED OR CONTRIBUTED TO THE EXCESS WEIGHT REMOVAL. THIS ISSUE WILL CONTINUE TO BE TREATED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED N. SALES/SERVICE CONTACTED BY INVESTIGATION? N. TRAINING REQUIRED? N.
INTRODUCER SYSTEM WAS BEING USED TO GAIN VASCULAR ACCESS IN THE PT'S GROIN FOR AN ARTERIOGRAM/ANGIOPLASTY PROCEDURE. THE GROIN SITE WAS EXTREMELY SCARRED AND ATTEMPTS TO GAIN ACCESS WITH ANOTHER MFR'S INTRODUCER SYSTEM PRIOR TO THIS ONE WERE UNSUCCESSFUL. UPON REMOVAL OF THE INTRODUCER THE RADIOPAQUE (RO) MARKER DETACHED AND REMAINED ON THE GUIDEWIRE. RETRIEVAL OF THE RO MARKER UTILIZING A BALLOON CATHETER WAS UNEVENTFUL. THERE WERE NO PT COMPLICATIONS INVOLVED. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY AND WILL NOT BE RETURNED FOR EVAL. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. FOLLOW UP REVEALED THIS PT'S SCAR TISSUE AT THE PUNCTURE SITE MADE GAINING ACCESS DIFFICULT. THEREFORE, CO BELIEVES PT'S ANATOMY CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE.
F10. 2060-NOT LABELED. 1527-NOT LABELED.
DURING PTCA PROCEUDRE, THE TIP OF THE GUIDE WIRE FRACTURED AS THE BALLOON CATHETER WAS REMOVED. THE BALLOON RUPTURED PRIOR TO REMOVAL. ALL PIECES WERE RETRIEVED. PT STATUS IS LISTED AS "OK." SAME CASE AS MFR REPORT #2183819-1996-00010.
ADD'L ANALYSIS REVEALED THAT THE WIRE WAS BENT AND FRACTURED AT THE JUNCTION OF THE SPRING TIP AND CORE WIRE. THE FRACTURE WAS APPARENTLY CAUSED BY SIGNIFICANT TENSILE FORCE PLACED ON THE DEVICE. NO MATERIAL OR MANUFACTURING DEFICIENCIES WERE NOTED.
HANGMAN'S FRACTURE TREATED WITH C1-C3 FUSION-TI FRAME WITH THIS DEVICE. POST-OP FOLLOW-UP X-RAYS SHOWED ONE BROKEN WIRE.
THE EXPLANTED DEVICE WAS RETURNED WITH NO DETAIL REGARDING THE CIRCUMSTANCES OF ITS USE OR THE DURATION OF IMPLANTATION. THE CABLES WERE FRACTURED AT THE CRIMP AND THERE WAS EXTENSIVE FRAYING AND LOOSE STRANDS IN THE PACKAGE. BOTH CRIMPS APPEARED ABNORMAL. ONE WAS COMPLETELY FLATTENED AND SHOWED NO EVIDENCE OF THE TYPICAL CRIMP "FOOTPRINT" WHICH SUGGESTS ANOTHER TOOL WAS USED IN PLACE OF THE SOFWIRE PLIERS. THE OTHER WAS CRIMPED WITH THE SOFWIRE PLIERS, BUT THE IMPRESSION ON THE CRIMP SUGGESTS AN INCOMPLETE CRIMP. THAT MAY OCCUR IF THE CRIMP IS NOT FULLY CAPTURED IN THE JAWS. AS A RESULT OF IMPROPER CRIMPING, THE STRENGTH OF THE CRIMP FITTING WAS NOTADEQUATE WHICH COULD LEAD TO PREMATURE FAILURE OF THE CABLE CONSTRUCT. IN THE ABSENCE OF RADIOGRAPHIC/CLINICAL HISTORY, WE ARE UNABLE TO ASCERTAIN IF FAILURE OF THE WIRES WAS "PREMATURE", OR THE RESULT OF FAILED FUSION.
ON 10/12/94, THE PT WAS IMPLANTED WITH A SINGLE-CHAMBER VENTRICULAR PACEMAKER AND ANOTHER MFR'S LEAD. PT PRESENTED WITH LOSS OF VENTRICULAR PACING. BOTH THE PACEMAKER AND THE OTHER MFR'S LEAD WERE EXPLANTED AND REPLACED.
510K #912002. SERIOUS INJURY. TYPE G. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS SEVERITY OF THIS EVENT GREATER THAN LABELED? N.
PT COMPLAINT OF PAIN AND RADIOGRAPH ALLEGEDLY SHOWED PROBABLE PATELLA LOOSENING. REVISION SURGERY PERFORMED. DURING PATELLA REVISION, TIBIAL INSERT WAS SCHECKED AND SOME WEAR WAS FOUND. DR DECIDED TO REPLACE INSERT DURING PATELLA SURGERY. TIBIAL INSERT WAS CUT WITH AN OSTEOTOME FOR EASIER REMOVAL AND REPLACED.
PER 9/26/96 REQUEST FOR ADDITIONAL INFO. USER FACILITY DID NOT PROVIDE ANY INFO STATING THAT THE INCIDENT OCCURRED BEFORE THE EFFECTIVE DATE OF THE MDR RULE. THREE CONTACTS WERE MADE AND DOCUMENTED WITH THE USER FACILITY REQUESTING ADDITIONAL INFO.
DR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.5MMD IMPLANT WAS PLACED IN THE #20 AREA OF THE MANDIBLE TO HELP SUPPORT A TWO-UNIT SPLINT. THE IMPLANT FUNCTIONED FOR LESS THAN A YEAR BEFORE IT BROKE AND THE SPLINT HAD TO BE REMOVED. THE PORTION OF THE IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THERE WAS NOT ENOUGH FRAGMENTS OF THE IMPLANT TO ADEQUATELY EVALUATE. THE PERIAPICAL RADIOGRAPH WITH NO DATE SHOWED THE 10MML 3.5MMD IMPLANT IN THE #20 AREA SUPPORTING A TWO-UNIT SPLINT. THE PERIAPICAL RADIOGRAPH WITH NO DATE SHOWED THE 10MML IMPLANT IN THE #20 AREA THAT APPEARED TO BE FRACTURED AT THE NECK. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FINDS THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE IMPLANT THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS RECOMMENDED TO REPLACE THE BROKEN IMPLANT WITH A WIDER ONE FOR THE ADD'L SUPPORT.
DURING A HEART STUDY, PT COMPLAINED OF CHEST PAIN. AIR WAS DETECTED AROUND THE PT'S HEART. PT WAS TAKEN TO CARDIAC CATH TO REMOVE AIR, BUT IT HAD DISSIPATED PRIOR TO PT'S ARRIVAL. A REVIEW OF THE FILMS BY THE HOSP INDICATED A VOLUME OF GAS BUT NO CONTRAST. SINCE THE INJECTOR INDICATED THAT IT HAS INJECTED 90CC, THE HOSP CONCLUDES THAT 90CC OF AIR WAS DELIVERED INSTEAD OF CONTRAST. THE INJECTOR WAS PROGRAMMED TO DELIVER 90CC AT 3ML/SEC USING 100ML PREFILLED SYRINGES. HOSP REPORTED THEY BELIEVE THE EXTENSION TUBING WAS NOT PRIMED PRIOR TO THE START OF THE INJECTION BY THE TECHNICIAN (TUBE PRIMING GENERALLY ACCOUNTS FOR AN APPROX 3ML AIR INJECTION). A CO'S SVC REP INSPECTED THE INJECTOR 9/4/96 AND FOUND IT OPERATING CORRECTLY. HOSP HAS REQUESTED CO TO PERFORM IN-SERVICE TRAINING FOR HOSP TECHNICIANS. TRAINING DATE WAS NOT CONFIRMED AT THIS TIME.      THIS TIME.
ON 9/5/96 CO'S BUSINESS UNIT DIRECTOR SPOKE WITH USER FACILITY'S RISK MANAGEMENT WHO INDICATED THAT A DECISION HAD NOT BEEN MADE IF THE HOSPITAL WAS GOING TO FILE A MEDWATCH REPORT. SHE REFUSED TO PROVIDE CO WITH A COPY OF THEIR RISK MANAGEMENT REPORT.
A PT WAS IN A USUAL STATE OF HEALTH UNTIL 3/23/96. ON 3/24/96 HIS WIFE WAS NOT ABLE TO AROUSE HIM. AT THE HOSPITAL HIS TEMPERATURE WAS SLIGHTLY EVALUATED AND HIS BLOOD SUGAR WAS 1091 MG/DL. HE WAS ADMITTED TO THE HOSPITAL WITH HYPERSMOLAR SHOCK AND R/O SEPSIS. THE PT INDICATED THAT HE REDUCED THE AMOUNT OF INSULIN BASED ON THE CO METER 3 READINGS OF "LO" (LESS THAN 20 MG/DL). UPON INVESTIGATION IT WAS DISCOVERED THAT THE CUSTOMER WAS GIVEN DIFFERENT REAGENT STRIPS INSTEAD OF CORRECT REAGENT STRIPS. PRODUCT LABELING SPECIFIES THE ONLY SPECIFIED REAGENT TO BE USED WITH THE CO METER IS CO'S STRIPS. THE SCENARIO EXPERIENCED BY THE CUSTOMER HAS BEEN CONFIRMED BY THESE IN-HOUSE STUDIES.
THE REAGENT STRIPS PROVIDED TO THE CUSTOMER BY THE VA WAS IN ERROR.
DR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 10MM 3.75 MMD IMPLANT WAS PLACED IN THE #12 AREA OF THE MAXILLA TO HELP SUPPORT AN ANTERIOR SPLINT. THE IMPLANT FUNCTIONED FOR OVER A YEAR BEFORE IT FAILED TO MAINTAIN OSSEOINTEGRATION AND HAD TO BE REMOVED. THE 10MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PERIAPICAL RADIOGRAPH DATED 7/15/96 SHOWED THE 10MML 3.75 MMD IMPLANT IN THE #12 AREA OF THE MAXILLA, SUPPORTING AN ANTERIOR SPLINT. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FOUND THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE IMPLANT THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS RECOMMENDED TO REPLACE THE FAILED IMPLANT WITH A WIDER ONE FOR THE ADD'L SUPPORT.
IMPLANT WAS EXPLANTED DUE TO A FRACTURED BASKUET. THE PT HAS A HISTORY OF LOOSENING SCREWS AND FRACTURED IME'S WHICH ARE MOST LIKELY CONTRIBUTING FACTORS.
86= DEVIDE WAS NOT RETURNED FOR EVALUATION.
TWO IMPLANTS WERE EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION.
H6: 86= A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT ALL COMPONENTS IN THIS LOT MET CO REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. TO DATE, NO OTHER INCIDENTS INVOLVING THIS LOT NUMBER HAVE BEEN REPORTED.
THE INVESTIGATIVE WORKSHEET STATED THAT THREE 10MML 3.75MMD IMPLANTS WERE PLACED IN THE #19, #29 & #29 AREAS, TWO 16MML 3.75MMD IMPLANTS WERE PLACED IN THE #22 & #28 AREAS AND ONE 13MML 3.75MMD IMPLANT WAS PLACED IN THE #30 AREA OF THE MANDIBLE. ON NOVEMBER 12, 1995 CROWNS WERE PLACED ON THE SIX IMPLANTS. THEY FUNCTIONED FOR A FEW MONTHS BEFORE THE IMPLANTS IN THE #29 AND #30 AREAS FRACTURED AND HAD TO BE REMOVED. THE PANORAMIC RADIOGRAPH DATED 5-10-95 SHOWED THE THREE 10MML 3.75MMD IMPLANTS IN THE #19, #20 & #29 AREAS, TWO 16MML 3.75MMD IMPLANTS IN THE #22 &#29 AREAS AND ONE 13MML 3.75MMD IMPLANT IN THE #30 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE IMPLANTS THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS RECOMMENDED TO REPLACE THE BROKEN IMPLANTS WITH WIDER ONES FOR THE ADDITIONAL SUPPORT
DURING A PTCA OF THE CIRCUMFLEX ARTERY, THE TIP OF THE GUIDEWIRE DETACHED AND REMAINED IN THE PT. THE PT WAS NOT SENT TO SURGERY INITIALLY. BUT IN RECOVERY THE PT DEVELOPED CARDIAC TAMPONADE AND WAS SENT TO EMERGENCY SURGERY. THE PT EXPIRED POST OPERATIVELY. THE ACCOUNT INDICATED THAT THE TIP OF THE GUIDEWIRE LIKELY HAD BECOME EMBEDDED INTO THE VESSEL WALL AND DETACHED WHILE REMOVING THE FROM THE PT.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PATIENT STATUS FROM A HOSPITAL OR FIELD CONTACT.
IN 6/96, DURING ROUTINE FLUSHING OF THE SYSTEM, PT EXPERIENCED BURNING PAIN AND SWELLING AT IMPLANTATION SITE. SUBSEQUENT X-RAY SHOWED CATHETER WAS BROKEN AND THE FRAGMENT ORIGINATED WAS IN RIGHT CARDIAC VENTRICLE. CATHETER EMBOLUS WAS RETRIEVED THROUGH FEMORAL VEINS.
E1 WAS ON ORIGINAL FORM BUT REPEATED INFORMATION AT YOUR REQUEST. H5 CODE 86 - PRODUCT NOT RETURNED. F10 CODE 1931 LABELED, 1994 NOT LABELED, AND 1261 LABELED.
THE INVESTIGATIVE WORKSHEET STATED THAT THREE 10MML 3.75MMD IMPLANTS WERE PLACED IN THE #19, #20 & #29 AREAS, TWO 16MML 3.75MMD IMPLANTS WERE PLACED IN THE #22 & #28 AREAS AND ONE 13MML 3.75MMD IMPLANT WAS PLACED IN THE #30 AREA OF THE MANDIBLE ON MAY 5, 1996. ON NOVEMBER 12, 1995 CROWNS WERE PLACED ON THE SIX IMPLANTS. THEY FUNCTIONED FOR A FEW MONTHS BEFORE THE IMPLANTS IN THE #29 & #30 AREAS FRACTURED AND HAD TO BE REMOVED. THE PANORAMIC RADIOGRAPH DATED 5-10-95 SHOWED THE THREE 10MML 3.75MMD IMPLANTS IN THE #19, #20 & #29 AREAS, TWO 16MML 3.75MMD IMPLANTS IN THE #22 & #28 AREAS AND ONE 13MML 3.75MMD IMPLANT IN THE #30 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE IMPLANTS THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS RECOMMENDED TO REPLACE THE BROKEN IMPLANTS WITH WIDER ONES FOR THE ADDITIONAL SUPPORT.
DR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.3 MMD IMPLANT WAS PLACED IN THE #18 AREA OF THE MANDIBLE ON 5/6/96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED IN 7/15/96. THE 10MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PANORAMIC RADIOGRAPH COPY DATED 8/23/96 SHOWED A 10 MML 3.3MMD IMPLANT IN THE #18 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
INFO REQUESTED ON 9/26/96. CONCLUSION STATEMENT: NO DEVICE FAILURE. ADD'L INFO: CAT # IS 1600-1105. PROD WAS MFG AND SOLD BY ANOTHER CO THE ASSETS OF WHICH WERE PURCHASED BY THIS CO. THREE CONTACTS TO USER FACILITY WERE MADE AND DOCUMENTED REQUESTING MEDWATCH FORM. INFO WAS NOT RECEIVED.
DURING A ROUTINE FOLLOW UP, A CHEST X-RAY SHOWED THE TIP OF THE CATHETER HAD BROKEN OFF AND WAS LODGED IN THE PT'S PULMONARY ARTERY. THE SYSTEM WAS EXPLANTED AND THE CATHETER EMBOLUS REMOVED. THE REPORTER STATED THAT THE PT SUFFERED NO INCIDENT RELATED MEDICAL SEQUELAE.
TIBIAL BASE WAS REVISED BECAUSE IT WAS BENT.
INFO REQUESTED ON 9/26/96. CONCLUSION STATEMENT: PRODUCT WORN DUE TO FRACTURED FEMORAL COMPONENT. PRODUCT WAS MFR AND SOLD BY ANOTHER CO, THE ASSETS OF WHICH WERE PURCHASED BY CO. THREE CONTACTS WERE MADE AND DOCUMENTED TO USER FACILITY REQUESTING MEDWATCH FORM. INFO WAS NOT RECEIVED.
THE PT, AN IDDM, BEGAN OBTAINING LOW READINGS ON HER METER ON 7/23, BUT WAS FEELING FINE. SHE REPORTS THAT SHE BEGAN FEELING SICK AFTER A FEW DAYS WITH NAUSEA AND VOMITING. SHE HAD CUT BACK ON HER INSULIN BECAUSE OF THE LOW METER READINGS, HOWEVER, CONTINUED TO TAKE ENOUGH INSULIN TO TAKE CARE OF HER MEALS. IN THE EVENING OF 7/25, SHE OBTAINED A READING OF 45 MG/DL ON HER METER AND CONSUMED A LARGE GLASS OF ORANGE JUICE. THE FOLLOWING MORNING (7/26) SHE AWOKE FEELING "REALLY SICK." HER 8:00/A METER READING WAS 70 MG/DL. SHE CALLED A FRIEND WHO TRANSPORTED HER TO THE HOSP. PRIOR TO DEPARTURE, SHE TOOK "NPH" INSULIN. UPON ARRIVAL AT THE HOSP AT 8:30/A, HER BS WAS TESTED WITH A RESULT OF "OVER 500" (UNKNOWN METHOD) AND IT WAS REPORTED THERE WAS "ACID IN HER URINE." SHE WAS PLACED ON AN IV OF UNKNOWN CONTENTS, HOOKED UP TO A HEART MONITOR (HER HEART RATE WAS "150-170") AND HAD BLOOD GASES AND OTHER TESTS PERFORMED. SHE WAS DISCHARGED AFTER 9 HRS WITH A PRESCRIPTION FOR VISUAL URINE TAPES. THE METER IS NOT CLEANED ACCORDING TO MFR'S RECOMMENDATIONS. NO WATER IS USED TO CLEAN THE METER OPTICS. CALIBRATION STATUS IS UNKNOWN AT THIS TIME.
CO HAS COMPLETED THEIR INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAS NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. REVIEW OF THE METER MEMORY INDICATES THAT QUALITY CONTROL TESTS ARE NOT PERFORMED (CHECKSTRIP AND CONTROL SOLUTION TEST). IN ADDITION, PRIOR TO 7/23 (THE REPORTED ONSET OF THE PT'S ILLNESS), NO BLOOD TESTING HAD BEEN PERFORMED ON THE METER SINCE 5/30/96. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNKNOWN ANOMALY. AT THIS POINT CO'S INVESTIGATION OF THIS MATTER IS CLOSED.
CONCLUSION STATEMENT: PRODUCT WORN DUE TO FRACTURED FEMORAL COMPONENT.      PRODUCT WAS MFR AND SOLD BY ANOTHER CO, THE ASSETS OF WHICH WERE PURCHASED BY THIS CO. THREE CONTACTS TO USER FACILITY WERE MADE AND DOCUMENTED REQUESTING MEDWATCH FORM. INFO WAS NOT RECEIVED.
DR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.5MMD IMPLANT WAS PLACED IN THE #15 AREA OF THE MAXILLA TO HELP SUPPORT A FIVE-UNIT BRIDGE. THE PROSTHESIS FUNCTIONED FOR OVER TWO YRS BEFORE THE IMPLANT FAILED TO MAINTAIN OSSEOINTEGRATION AND HAD TO BE REMOVED. THE 10MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECS. THE PERIAPICAL RADIOGRAPH WITH NO DATE SHOWED THE 10MML 3.5 MMD IMPLANT IN THE #15 AREA SUPPORTING A FIVE-UNIT BRIDGE. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FOUND THAT THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE IMPLANT THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS RECOMMENDED TO REPLACE THE FAILED IMPLANT WITH A WIDER ONE FOR THE ADD'L SUPPORT.
DOCTOR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 16MML 4.25MMD IMPLANT WAS PLACED IN THE #8 AREA OF THE MAXILLA ON        6-13-94. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED IN MAY, 1995. THE 16MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MANUFACTURER'S SPECS. THE PERIAPICAL RADIOGRPH WITH NO DATA SHOWED THE 16MML 4.25MMD IMPLANT IN THE #8 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
ON 7/29/96, THE PT WAS ADMITTED TO THE HOSP FOR TREATMENT OF HYPERGLYCEMIA. HIS ADMITTING BLOOD GLUCOSE LEVEL (METHOD UNKNOWN) WAS "999" MG/DL. HE WAS TREATED WITH A SLIDING SCALE OF INSULIN EVERY TWO HOURS (DOSAGE NOT PROVIDED), AS WELL AS AN IV 150/HR (REPORTER STATED THE PT WAS DEHYDRATED). THE PT'S METER "STOPPED TURNING ON A COUPLE OF DAYS" PRIOR TO HOSPITALIZATION AND THUS WAS UNABLE TO TEST HIS BLOOD GLUCOSE. IT IS UNKNOWN IF HE CEASED TAKING HIS ORAL MEDICATION AS A RESULT OF THE INABILITY TO TEST. METER MAINTENANCE AND CALIBRATION STATUS ARE UNKNOWN.
CO HAS COMPLETED THE INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE. CO WAS UNABLE TO PERFORM AN EVALUATION OF THE SUBJECT DEVICE BECAUSE THE METER WOULD NOT POWER ON UPON RECEIPT. IT WAS DETERMINED THAT A BATTERY CONTACT WAS CORRODED AND BROKEN, CAUSING LOSS OF POWER.
THE TOP OF THE DOME PERFORATED THE INFERIOR VENA CAVA. NO EXTRAVASATION OR BLEEDING OCCURRED. THE PERFORATION WAS ASYMPTOMATIC. THE PT WAS MONITORED AND NO ADD'L COMPLICATIONS OR PROCEDURES ARE ANTICIPATED.
H3. ACTUAL DEVICE REMAINS IMPLANTED. THE SAMPLE RECEIVED WAS ANGIOGRAPH FILM. DESCRIPTION OF COMPLAINT: THE TOP OF THE DOME PERFORATED THE INFERIOR VENA CAVA. REVIEW OF THE ANGIOGRAPHS SHOW THAT THE FILTER TIP IS OUTSIDE OF THE CONTRAST COLUMN. THE REST OF THE FILTER DOME AND THE FILTER LEGS ARE WITHIN THE CONTRAST COLUMN. THERE IS NO CONTRAST EXITING THE INFERIOR VENA CAVA IN THE VICINITY OF THE FILTER DOME TIP. NO EXTRAVASATION OR BLEEDING OCCURRED. PERFORATION IS ASYMPTOMATIC. PT WAS MONITORED AND NO ADD'L COMPLICATION OR PROCEDURES OCCURRED. MEDICAL REVIEW OF THE ANGIOGRAPH FILMS BY CO'S SCIENTIFIC DIRECTOR DETERMINED THAT IT IS NOT A PERFORATION, BUT A NARROW CREASE (EVAGINATION) OF THE VENA CAVA WALL AROUND THE FILTER TIP. IS CANNOT BE DETERMINED COMPLETELY THAT THE TOP OF THE DOME PERFORATED THE INFERIOR VENA CAVA. MONITOR TRENDING DATA TO DETERMINE FREQUENCY OF PHENOMENON.
DOCTOR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.75MMD IMPLANT WAS PLACED IN THE #10 AREA OF THE MAXILLA ON       7-15-96. THE IMPLANT FAILED TO OSSEOIMTEGRATE AND WAS REMOVED ON 8-7-96. THE 10MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINEED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MANUFACTURER'S SPECS. THE PERIAPICAL RADIOGRAPH DATED 8-19-96 SHOWED THE 10MML 3.75MMD IMPLANT IN THE #10 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAY AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
DOCTOR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 16MML 3.7MMD IMPLANT WAS PLACED IN THE #7 AREA OF THE MAXILLA ON 4-2-96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED IN 5-24-96. THE 16MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL TOLERANCES NECESSARY TO COMPLY WITH THE MFR'S SPECIFICATIONS. THE PERIAPICAL RADIOGRAPH COPY DATED 5-6-96 SHOWED A 16MML 3.7MMD IMPLANT IN THE #7 AREA OF THE MAXILLA. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
THE PUSHER WIRE WOULD NOT ADVANCE THE FILTER THROUGH THE INTRODUCER. THE FILTER BECAME STUCK IN THE CATHETER. ALSO, WHEN TRYING TO FURTHER ADVANCE THE FILTER, THE PUSHER WIRE KINKED. THE CATHETER WAS CUT AND THE FILTER WAS REMOVED. A COMPETITOR'S FILTER WAS ADVANCED THROUGH THE REMAINING PORTION OF THE CATHETER. NO FURTHER COMPLICATIONS WERE REPORTED.
DESCRIPTION OF COMPLAINT: THE WIRE WOULD NOT ADVANCE THE FILTER THROUGH THE INTRODUCER. DURING DEPLOYMENT, THE FILTER BECAME STUCK IN THE CATHETER AND WOULD NOT ADVANCE. ALSO, WHEN TRYING TO ADVANCE THE FILTER FURTHER, THE PUSHER WIRE KINKED. THE FEET BECAME CAUGHT IN THE SPACE BETWEEN THE TIP OF THE MALE LUER OF THE STORAGE TUBE AND THE FEMALE HUB OF THE CATHETER SHEATH. THIS OCCURRED BECAUSE THE HUB WAS NOT TIGHTENED SUFFICIENTLY AS DESCRIBED IN THE INSTRUCTIONS FOR USE. "NOTE: THE INTRODUCER HUB HAS A SPECIAL INTERNAL DESIGN. CARE SHOULD BE TAKEN TO MAKE CONNECTIONS FIRMLY, BUT WITHOUT EXCESSIVE FORCE THAT MAY CAUSE BREAKAGE TO THE HUB." A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 12-068737 CONFIRMED THAT THIS DEVICE  WAS SUBJECTED TO AND SATISFIED ALL CURRENT QUALITY STANDARDS SPECIFIED IN THE APPLICABLE DEVICE MASTER RECORD. THE FEET BECAME CAUGHT IN THE SPACE BETWEEN THE TIP OF THE MALE LUER OF THE STORAGE TUBE AND THE FEMALE HUB OF THE CATHETER SHEATH. THIS OCCURRED BECAUSE THE HUB WAS NOT TIGHTENED SUFFICIENTLY AS DESCRIBED IN THE INSTRUCTIONS FOR USE. TRENDING FOR THIS COMPLAINT WILL CONTINUE.
DOCTOR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 13MML 3.25MMD IMPLANT WAS PLACED IN THE #25 AREA OF THE MANDIBLE ON       6-6-96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 6-24-96. THE 13MML IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH THE MANUFACTURER'S SPECS. THE PERIAPICAL RADIOGRAPH DATED 6-6-96 SHOWED THE 13MML 3.25MMD IMPLANT IN THE #25 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
DOCTOR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT A 10MML 3.75MMD IMPLANT WAS PLACED IN THE #18 AREA OF THE MANDIBLE ON      10-13-95. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 8-12-96. THE PERIAPICAL RADIOGRAPH DATED 6-26-96 SHOWED A 10MML 3.75MMD IMPLANT IN THE #18 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
DOCTOR WAS SENT INVESTIGATION FORM. THE INVESTIGATIVE WORKSHEET STATED THAT TWO 15MML 3.75MMD IMPLANTS WERE PLACED IN THE #21 AND #28 AREAS AND A 13MML 3.25MMD IMPLANT WAS PLACED IN THE #24 AREA OF THE MANDIBLE ON 6-3-96. THE IMPLANTS FAILED TO OSSEOINTEGRATE AND WERE REMOVED ON 7-31-96. THE PERIAPICAL RADIOGRAPHS DATED 7-29-96 SHOWED THE TWO 15MML 3.75MMD IMPLANTS IN THE #21 & #28 AREAS AND A 13MML 3.25MMD IMPLANT IN THE #24 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THESE DENTAL IMPLANTS FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
PT WAS ADMITTED TO HOSP WITH COMPLAINTS OF A WORSENING COUGH (WHICH BEGAN WHILE HE WAS A PT AT ANOTHER HOSP) AND SHORTNESS OF BREATH. WHEN NO RELIEF WAS OBTAINED FROM ANTIBIOTICS, A BRONCHOSCOPY WAS PERFORMED, WHICH REVEALED A FOREIGN BODY IN THE BRONCHUS INTERMEDIUS. SIGNIFICANT DECREASE IN COUGH WAS IMMEDIATELY NOTED AFTER REMOVAL OF THE FOREIGN BODY. THE FOREIGN BODY IS THOUGHT ALMOST CERTAINLY TO BE A TRACH MASK CLIP. (THE PT HAS A TRACHEOTOMY.)
PT UNDERGOING CIRCUMCISION RECEIVED A SECOND DEGREE BURN ON LEFT THUMB, IN THE VICINITY OF A PULSE OXIMETER OXYGEN TRANSDUCER PROBE.
OXYGEN TRANSDUCER WAS MISUSED BY CONNECTING IT TO ANOTHER CO'S PULSE OXIMETER VIA A 3RD CO'S INTERFACE CABLE. NEITHER THE OXYGEN TRANSDUCER NOR THE INTERFACE CABLE ARE INTENDED FOR USE WITH THESE PULSE OXIMETERS. THE ALLEGED BURN WAS REPORTED TO BE A SECOND DEGREE BURN, APPROX 8MM IN DIAMETER IN THE VICINITY OF THE OXYGEN TRANSDUCER APPLICATION SITE. THE HOSP HAS INFORMED CO THAT THERE WAS NO LONG TERM HARM TO THE PT. THIS CO HAS AN OEM AGREEMENT WITH THE INTERFACE CABLE MFR UNDER WHICH THAT CO PURCHASES THIS CO'S OEM OXIMETRY CIRCUIT BOARDS FOR USE INSIDE THEIR MONITORS. THE INTERFACE CABLE IS INTENDED TO ALLOW THE USE OF THE CO OXYGEN TRANSDUCERS WITH THEIR MONITORS THAT CONTAIN THE CO OXIMETRY BOARDS. CO DOES NOT HAVE A LICENSING OR OEM AGREEMENT WITH THE PULSE OXIMETER MFR. CO CONSIDERS THE USE OF ITS OXIMETRY PRODUCTS IN COMBINATION WITH OTHER CO PRODUCTS AS UNINTENTIONAL MISUSE BY THE USER FACILITY. CO HAS COMPLETED AN EVALUATION OF THE OXYGEN TRANSDUCER RETURNED BY THIS HOSP. THIS OXYGEN TRANSDUCER PASSES ALL TEST INCLUDING A TEMPERATURE TEST.
ACCORDING TO THE DISCHARGE SUMMARY, THE PT WAS ADMITTED ON 5/21/96 AND A SINGLE CHAMBER VIA PACEMAKER LEAD WAS INSERTED. THE PT TOLERATED THE PROCEDURE WELL AND WAS RETURNED TO A GENERAL MEDICAL WARD ON TELEMETRY. LATER THAT NIGHT, THE PT'S PACEMAKER LEAD LOST CAPTURE AND THE PT'S HEART RATE REMAINED AT 37. THE PT WAS RETURNED TO CARDIAC CATHETERIZATION LAB THE NEXT MORNING. THE PHYSICIAN FELT THE REASON THE LEAD HAD LOST CAPTURE WAS THAT THE PT'S ENDOCARDIUM WAS SMOOTH AND THE TINED LEAD HAD DIFFICULTY MAKING CONTACT WITH THE ENDOCARDIUM. THUS THE TINED LEAD WAS REPLACED WITH AN ACTIVE FIXATION LEAD.
DURING THE PROCEDURE, THE SHAFT OF THIS DEVICE KINKED. IT IS UNK IF THE DEVICE KINKED DURING OR AFTER HAVING CROSSED THE HEART VALVE. IT WAS NECESSARY TO USE A WIRE IN ORDER TO REMOVE THIS DEVICE. THERE IS NO REPORT OF PT INJURY.
ACCORDING TO THE PHYSICIAN'S REPORT, PT UNDERWENT PACEMAKER PLACEMENT AT ANOTHER HOSP IN 1/95. PT HAD BEEN ADMITTED TO MED CTR FOR UNSUCCESSFUL PACEMAKER REVISIONS, WITH SKIN EROSION NOTED BOTH TIMES. PT HAD PERSISTENT DRAINAGE FROM THE EXPOSED AREA OF THE PACEMAKER SYSTEM WITH WIRES THAT HAD ERODED THE SKIN. PT WAS ADMITTED FOR PACEMAKER REMOVAL.
DURING THE PROCEDURE, THE SHAFT OF THIS DEVICE KINKED WHILE ATTEMPTING TO CROSS THE HEART VALVE. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE.
ACCORDING TO THE NURSE'S NOTES, WHILE PRESSURE WAS BEING APPLIED TO RIGHT GROIN WITH C-CLAMP OVER ARTERY, CLIENT BENT LEFT LEG AND MOVED SLIGHTLY. AT THIS POINT, THE DISK OVER THE CLIENT'S RIGHT ARTERY SHATTERED CAUSING THE DISK TO RELEASE PRESSURE OVER THE AREA. THE DISK SHIFTED AND THE SIDE OF IT MASKED INTO THE CLIENT'S LEG.
THE DEVICE WAS USED DURING A LAPAROSCOPY, OVARIAN CYSTECTOMY. THE 512S INNER GASKET FELL INTO THE PT WHEN AN INSTRUMENT WAS INSERTED. THE GASKET WAS LAPAROSCOPICALLY RETRIEVED FROM THE PT. ANOTHER 512S WAS INTRODUCED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
FOLLOW UP LETTER SENT TO FACILITY REQUESTING ADDITIONAL INFORMATION.
DURING THE PROCEDURE THE SHAFT OF THIS DEVICE KINKED WHILE ATTEMPTING TO CROSS THE HEART VALVE. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE.
SINGLE CHAMBER SENSELOG PACEMAKER INSERTED 1989. GENERATOR EXPLANTED 12/29 AND ATRIAL LEAD AND DUAL CHAMBER GENERATED IMPLANTED. PT RETURNED TO EP STUDIES ROOM 12/30/95 FOR ATRIAL LEAD MANIPULATION. LEAD HAD SUDDENLY WITHDRAWN TO THE SUPERIOR VENA CAVA WITH SUBSEQUENT PHRENIC NERVE STIMULATION. LEAD WAS RE-IMPLANTED 12/40/95 AND REMAINED IN EXCELLENT POSITION THROUGHOUT REST OF STAY.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE INNER GASKET ON THE FLAPPER VALVE CAME OFF AND FELL OFF INTO HE PT. THE GASKET WAS RETRIEVED WITHOUT INCIDENT. NO OTHER INFO WAS AVAILABLE. THERE WAS NO CONSEQUENCE TO THE PT.
D5;H4: INFORMATION UNAVAILABLEF1:HSOULD NOT HAVE BEEN CHECKED ON INITIAL MEDWATCH. NO MEDWATCH WAS RECEIVED BY USER FACILITY. G4:INFORMATION UNAVAILABLE. RESULTS OF EVALUATION: CONCLUSION: A,B) BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE SLEEVES WERE "BROKEN" DURING SURGERY. INSTRUMENT "A" WAS SHATTERED DISTALLY, AND ALL THE PIECES COULD NOT BE ACCOUNTED FOR. INSTRUMENT "B" WAS BROKEN 1" DISTAL TO THE HOUSING/CANNULA WELD. THE OBTURATORS WERE NOT RECEIVED FOR ANALYSIS. C-F) THESE INSTRUMENTS WERE RECEIVED IN UNOPENED BLISTER PACKS. THE INSTRUMENTS WERE EXAMINED AND FOUND TO BE CONFORMING.
DURING THE PROCEDURE, THE SHAFT OF THIS DEVICE KINKED WHILE ATTEMPTING TO CROSS THE HEART VALVE. THE DEVICE WAS REMOVED AND REPLACED. PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR ANALYSIS.
T CONNECTOR ATTACHED TO PICC LINE. PIGTAIL BROKE OFF T CONNECTOR. PICC LINE OCCLUDED. UNABLE TO UNCLOT. PICC LINE PULLED. PERIPHERAL IV STARTED.
DURING A DIALYSIS TREATMENT, THERE WAS EXCESS WEIGHT REMOVAL DUE TO DRIFTING OF THE NEGATIVE PRESSURE CONTROLLER. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A MES (MEDICAL EQUIP SVC) TECH EXAMINED THE MACHINE AND REPLACED THE NEGATIVE PRESSURE CONTROLLER. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC S/N MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC S/N MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE SINCE THE TRACEABILITY PRE-DATES THE DATABASE. THE NEGATIVE PRESSURE CONTROLLER MET ALL MFG SPECS. THERE WAS NO FUTHER TESTING DONE ON THE NEGATIVE PRESSURE CONTROLLER SINCE ITS OPERATION IS NOT AFFECTED BY TEMP OR POWER CYCLING. THE RETURNED NEGATIVE PRESSURE CONTROLLER MET MFG SPECS. THE CAUSE OF THE REPORTED INCIDENT WAS MOST LIKELY THE FACILITY'S FAILURE TO CORRECTLY SET THE UF RATE ON THE MACHINE. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED: N. SALES/SVC CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
DELAMINATION OF PATELLA WITH WORN ARTICULATING SURFACE. PATELLA REMOVED BUT NOT REPLACED. ARTICULATING SURFACE WAS REPLACED.
EKG DOCUMENTED NO PACEMAKER ACTIVITY - PACEMAKER GENERATOR INSERTED 10/5/92. LEAD WAS IMPLANTED IN 1977. AT TIME OF PROCEDURE (2/23/96), LEAD WAS FOUND TO HAVE AN EXPOSED WIRE WITHOUT INSULATION. THIS LEAD WAS CAPPED, THE GENERATOR EXPLANTED AND REPLACED. NEW VENTRICULAR LEAD WAS IMPLANTED.
THERE WAS NO AUDIO ALARM. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF TESTING. NO PARTS WERE REPLACED. IT IS NOT VERIFIED THAT THE ALARM WAS MALFUNCTIONING, AND NO MALFUNCTION MAY HAVE OCCURRED.
IT IS UNK WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
NAIL BROKE REQUIRING EXPLANATION AND REIMPLANTATION OF A NEW NAIL.
VELCRO STRAPS ON COLLAR CAME LOOSE X 2 FOR PT. PT DEVELOPED INCREASED PAIN. COLLAR J REMOVED AND ANOTHER COLLAR APPLIED. TWO COLLARS WERE TRIED. BOTH VELCRO STRAPS OPENED SPONTANEOUSLY. LOT TO BE RECALLED BY MFR.
M.G.I PATELLA COMPONENT DELAMINATED; (WHITE).
CO HAS BEEN INFORMED BY THE MFR THAT THE SUBJECT DEVICE IS NOT A TISSUE EXPANDER AS STATED IN THE LEGAL CLAIM. THE DEVICE IS A MAMMARY IMPLANT AN AN MDR HAS BEEN SUBMITTED BY THE MFR TWO AND HALF YEARS AGO. THE DEVICE WAS NOT DISTRIBUTED BY CO.
IMPLANT IN 1992. REVISED IN 7/31/96, DUE TO FRACTURE OF STEM COMPONENT.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS TYPE OF EVENT IS NOT OCCURRING WITH GREATER SEVERITY THAN WOULD BE ANTICIPATED. THE FREQUENCY OF OCCURRENCE OF THIS TYPE OF EVENT IS NOT KNOWN. HOWEVER, THE FREQUENCY WITH WHICH THIS EVENT IS OCCURRING IS GREATER THAN HAS BEEN EXPERIENCED WITH OTHER TYPE FEMORAL STEMS SOLD BY CO. THIS MODEL DEVICE HAS NOT BEEN MARKETED SINCE 11/12/92. USER FACILITY IS OUTSIDE OF THE US. NO MEDWATCH WAS RECEIVED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT. RECALL NO Z-1064/1068-5. THE FOOD AND DRUG ADMINISTRATION HAS COMPLETED THE AUDIT OF FIRM'S ACTION CONCERNING THE RECALLS OF FEMORAL STEMS DUE TO A HIGHER THAN EXPECTED RATE OF STEM FRACTURE. FDA CONCLUDED THAT THESE RECALLS HAVE BEEN COMPLETED AND APPROPRIATE ACTION TAKEN CONCERNING RETURNED GOODS. THEREFORE, FDA CONSIDERS THESE RECALLS TERMINATED.
PT REMOVED OWN HEP LOC AT 0430 2/16. PT REFUSED WARM COMPRESSES ALTHOUGH SITE WAS WARM, RED AND EDEMATOUS FROM KNUCKLE TO AFTER WRIST. A 20G 1 1/4 WAS INSERTED ON 2/13 AT 1630 IN L WRIST IN TC. PT REMOVED CATHETER ON 2/16 AT 0430. SITE WAS EXAMINED ON 2/15 1500 AND FOUND TO BE REDDENED BUT WITHOUT PAIN. ON 2/17 TREATMENT WITH IV ANTIBIOTIC AND WARM COMPRESSES. RECEIVED IV WITH KCL 20 MEQ @ 100 CC/HR. FLUSHED LOCK WITH 0.9% SALINE EVERY 8 HR. ON 2/17 TREATMENT WITH ANCEF 1 GM EVERY 8 HR FOR CELLULITIS. EXPIRATION DATE 10/2000.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION WAS ON 2/21/77 WITH EXPLANT 9/17/93. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, ATYPICAL CONNECTIVE TISSUE DISEASE, SJORGEN'S SYNDROME, AND MEMORY LOSS.
MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT, CO HAS NOT SOKD THIS PRODUCT SINCE 1984.
TWO IMPLANTS WERE EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. THE DR INDICATED THAT DIABETES MAY HAVE BEEN A CONTRIBUTING FACTOR.
BECAUSE TISSUE WAS PRESENT, THE COATING DIAMETER COULD NOT BE MEASURED. THE RETURNED COMPONENT MET THE REMAINING INTERPORTE VISUAL AND DIMENSIONAL SPECIFICATIONS. H6: 86 = DIMENSIONAL ANALYSIS.
STENT INSERTED. BALLOON FAILED TO INFLATE. STENT REMOVED. SECOND STENT INSERTED SUCCESSFULLY.
PT RECEIVED MINOR BURN DUE TO WIRE PULLING OUT OF ELECTRODE. NO SPECIAL TREATMENT OF THE BURN WAS NECESSARY.
INITIAL IMPLANTATION OF ONE IMPLANT WAS ON 2/21/77 WITH EXPLANT 9/17/93. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LINKED TO, SJORGEN'S SYNDROME, ATYPICAL CONNECTIVE TISSUE DISEASE, AND MEMORY LOSS.
PT UNDERWENT EXPLANTATION OF BILATERAL BREAST IMPLANTS AND CAPSULECTOMIES. IMPLANTS WERE INTACT UPON EXPLANTATION.
PT X-RAYED ON COMPLAINT OF PAIN. ROD HAD SLIPPED FROM RIGHT SLOTTED CONNECTOR. AT SURGERY FOR REMOVAL, HE WAS FUSED L2-L4. ROD HAD SLIPPED FURTHER SO THAT CEPHALAD END WAS AT L4 LEVEL.
IS FREQUENCY OR OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? NO. IS SEVERITY OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IS THE SEVERITY OF THIS EVENT GREATER THAN LABELED ? NO. A REPORT OR OTHER INFO SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT NECESSARILY RELFECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT OR BY FDA THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, OR THE REPORTING ENTITY OR ITS EMPLOYEES OR AGENTS, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE REPORTING ENTITY NEED NOT ADMIT AND MAY DENY (AND EXPRESSLY RESERVES THE RIGHT TO DENY) THAT THE DEVICE, THE PARTY SUBMITTING THE REPORT, OR EMPLOYEES THEREOF, CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
NO ADDITIONAL INFORMATION TO BE SUBMITTED.
PT DESIRED REMOVAL OF BREAST IMPLANTS TO ALLOW FOR BREAST FEEDING. THE RIGHT IMPLANT WAS RUPTURED BEFORE REMOVAL; BOTH BREASTS HAD CAPSULAR CONTRACTURE.
INITIAL IMPLANTATION OF THE LEFT IMPLANT WAS ON 12/8/81. LAWSUIT FILED FOR UNDISCLOSED "DAMAGES."
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO. 92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE, IN THE 334TH JUDICIAL DISTRICT OF HARRIS CTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
PT UNDERWENT EXPLANTATION OF RIGHT BREAST IMPLANT AND CAPSULECTOMY AND IMPLANT REPLACEMENT.
TIP OF SCREWDRIVER BROKE OFF IN SCREW AND COULD NOT BE REMOVED BY ITSELF. THEREFORE, THE COMPLETE INSTRUMENTATION, INCLUDING THE SCREW, HAD TO BE REMOVED.
H.4 -DEVICE MANUFACTURE DATE NOT AVAILABLE BECAUSE THE MFG LOT NUMBER WAS NOT PROVIDED AND DID NOT APPEAR ON THE INSTRUMENT. D.6 - THIS INSTRUMENT MAY NOT HAVE BEEN MFG BY CO. EVIDENCE SUGGESTS THAT THE SCREWDRIVER SHAFT WAS FROM A DIFFERENT MFR. PRODUCT OF THIS COMPLAINT WAS SUBMITTED AS SHOWN IN FIGURE 1. THE TIP OF A SCREWDRIVER HAD FRACTURED WITHIN THE HEX OPENING OF A POLYAXIAL SPINAL SCREW. THE FRACTURE FACE SHOWED CLEAR INDICATIONS OF OVER-TORQUE AND CANTILEVER BENDING AS EXAMINED UNDER MAGNIFICATION AND A WHITE LIGHT SOURCE (FIGURE 2 AND 3). FIGURE 4 SHOWS THE TIP LODGED WITHIN THE POLYAXIAL HEAD AND THE ARROW POINTS TO THE "SWIRLED" EFFECT OF THE CORNERS OF THE TIP WHICH HAVE BEEN DEFORMED UNDER TORQUE LEAD. THERE IS ALSO QUESTION WHETHER THE SCREWDRIVER WAS CO'S PRODUCT. THE INSTRUMENT HAD AN UNFAMILIAR MARK LASER ETCHED AS SHOWN IN FIGURE 5. THE MARK "REP 4/96" IS NOT AN IDENTIFICABLE MARK. LABELING FOR THIS PART SHOULD HAVE BEEN LASER ETCHED TOWARD THE HANDLE END WITH "CO 2745-32." THE PART SHOULD HAVE ALSO CONTAINED A LOT #. DESPITE THE QUESTION OF WHETHER THIS WAS CO'S PRODUCT, DIMENSIONAL AND HARDNESS MEASUREMENTS WERE MADE ON THE TIP TO COMPARE TO ENGINEERING REQUIREMENTS. THE FRACTURED TIP WAS CAREFULLY REMOVED FROM THE POLYAXIAL SCREW BY CUTTING AWAY THE SURROUNDING BODY. -LENGTH OF THE TIP IS REQUIRED TO BE .160 (+/-.010 IN). BROKEN TIP WAS OVERSIZED AT 0.183 INCH. IT IS POSSIBLE THE TIP PLASTICALLY LENGTHENED DURING FRACTURE. -ACROSS CORNERS IS REQUIRED TO BE .153 IN MIN. BROKEN TIP ACROSS CORNERS WERE WITHIN PRINT AT .157 INCH. -HEX IS REQUIRED TO BE .1365 (=.0010 & -.0005). BROKEN TIP HEX MEASURED 0.138 INCH. -HARDNESS IS REQUIRED TO BE HRC 44 MIN. BROKEN TIP WAS MOUNTED AND AVG KNOOP MICROHARDNESS AS HK 447 WHICH CONVERTS TO HRC 43.5. MESUREMENTS MADE WERE WITHIN ENGINEERING REQUIREMENTS, HOWEVER IT IS STILL IN QUESTION OF WHETHER THIS INSTRUMENT IS A CO'S PRODUCT OR AN ALTERED CO'S PRODUCT IN WHICH CASE CO CANNOT GUARANTEE THE PERFORMANCE OF AN ALTERED PRODUCT. THE PRODUCT AND SUPPORTING DOCUMENTATION HAS BEEN FORWARDED TO QUALITY FOR CLOSURE.
FOLLOWING CORONARY ARTERY BYPASS GRAFTS TO LEFT ANTERIOR DESCENDING AND RIGHT CORONARY ARTERIES, AND MITRAL VALVE REVISION (ONE LEAFLET WAS "SHORTENED"), MITRAL VALVE REPLACEMENT WAS ACCOMPLISHED USING AORTIC MECHANICAL HEART VALVE. AT THE CONCLUSION OF THE PLACEMENT OF THIS VALVE, IT WAS NOTED THAT ONE OF THE LEAFLETS WAS MISSING. SURGEON WAS UNABLE TO RETRIEVE LEAFLET THROUGH AORTIC VALVE, THEREFORE, VENTRICULOTOMY WAS PERFORMED. LEAFLET WAS LOCATED AT BASE OF CHORDAE TENDINEAE AND REMOVED. AORTIC VALVE WAS THEN REPLACED USING A DIFFERENT AORTIC MECHANICAL HEART VALVE. VENTRICULOTOMY WAS REPAIRED, INCISION CLOSED AND PT TAKEN OFF BYPASS. WAS TAKEN TO CVICU CARE UNIT IN GUARDED CONDITION.
INITIAL IMPLANTATION OF THE RIGHT IMPLANT WAS ON 12/8/81. LAWSUIT FILED FOR UNDISCLOSED "DAMAGES."
PLAINTIFF ADOPS MASTER PETITION FILED IN CAUSE NO. 92-16550; IN RE: MASTER SILICONE IMPLANT FILE, HARRIS CTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
UMBILLICAL VENOUS CATHETER FOUND TO BE FRACTURED IN THE RIGHT ATRIUM/VENTRICLE BY PATHOLOGIST.
IMPLANTED IN 1992. REVISED ON 7/15/96. EXTENSIVE OSTEOLYSIS FOUND BEHIND SHELL.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. USER FACILITY REPORT INDICATED THAT THE LOT NUMBER FOR PART # 104302 WAS 441170, IT IS 441140 AS REFLECTED ON CO'S MED WATCH REPORT. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OT THE EVENT.
INITIAL BILATERAL IMPLANTATION WAS ON 10/22/82. LAWSUIT FILED FOR UNDISCLOSED "DAMAGES."
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO. 92/16550;IN RE: MASTER SILICONE BREAST IMPLANT FILE. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
THE OR SCRUB NURSE WAS MIXING A BATCH OF BONE CEMENT. FOLLOWING EXPOSURE TO THE CEMENT VAPORS, THE NURSE EXPERIENCED NAUSEA AND A HEADACHE. THE NURSE WAS TREATED IN THE EMERGENCY ROOM FOR THE SYMPTOMS. SHE WAS RELEASED BACK TO WORK AFTER TREATMENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME DUE TO THIS EVENT.
INFO HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVALUATION: THE RESULTS OF THE MFR'S EVALUATION SUGGEST THAT EXPOSURE TO HIGH CONCENTRATIONS OF THE LIQUID VAPORS MAY RESULT IN THE CONDITION OBSERVED. THE MFR RECOMMENDS THAT MIXING BE PERFORMED IN A WELL VENTILATED AREA TO AVOID RESPIRATORY IRRITATION AND OTHER DISCOMFORT. THIS INFORMATION AND OTHER WARNINGS ARE DOCUMENTED IN THE PRODUCT LITERATURE, WHICH IS SUPPLIED WITH EVERY PACKAGED PRODUCT.
RESIDENT PLACED IN CHAIR IN RECLINING POSITON. CHAIR WHICH WAS AT THE TIME IN THE UPRIGHT POSITON. APPARENT INJURY TO RESIDENT. SUPPORTIVE BRACE FOR POSITION LOCKING MECHANISM FOUND TO BE LOOSE/BROKEN THUS ALLOWING CHAIR TO BE SECURED IN RECLINING POSITION.
INITIAL BILATERAL IMPLANTATION WAS ON 5/17/77. LAWSUIT FILED FOR UNDISCLOSED "DAMAGES."
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO. 92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE, HARRIS CTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
STENT BALLOON WOULD NOT PASS OVER WIRE. UNABLE TO USE DEVICE. ANOTHER USED.
INITIAL BILATERAL IMPLANTATION WAS ON 3/8/84. LAWSUIT FILED FOR UNDISCLOSED "DAMAGES."
STENT BALLOON RUPTURED DURING PREP. BALLOON NEVER ENTERED PT.
IMPLANTED IN 2/91. ACETABULAR COMPONENT WAS REVISED ON 7/23/96 DUE TO OSTEOLYSIS. LINER COMPONENT FOUND WORN AND BROKEN UPON REMOVAL.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. A FAX WAS SENT ON 8/14/96 TO THE USER FACILITY. CO DID NOT RECEIVE A MEDWATCH REPORT FROM THE USER FACILITY. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT.
A PT WAS CAUGHT ON FIRE AT A PARKING METER NEXT TO A PARKING LOT (USING CO SYSTEM)." IT WAS INITIALLY REPORTED THAT THE PT RECEIVED 2ND AND 3RD DEGREE BURNS ON HER BACK AND ARMS. THE FIRE MARSHALL'S REPORT STATED THAT "THE PT HAD GOTTEN OUT OF HER CAR AND WAS WALKING TO THE PARKING METER. SHE WAS GOING TO PUT SOME COINS IN THE PARKING METER WHEN ALL OF A SUDDEN HER BLOUSE AND THE OXYGEN TANK UNIT THAT SHE WAS WEARING JUST BURST INTO FLAMES." THE FIRE MARSHALL ALSO STATED "THAT THEY USED A DRY POWDER FIRE EXTINGUISHER TO EXTINGUISH THE BURNT CLOTHING THAT HAD TAKEN OFF AND THE OXYGEN TANK SHE WAS WEARING." PRELIMINARY INVESTIGATION BY THE FIRE MARSHALL AND THE CRIME LAB REVEALED THE DEVICE WAS FUNCTIONAL AT THE TIME OF THE INVESTIGTION (SEE ATTACHMENT 1). THE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. THE SYSTEM IS BEING HELD PENDING LITIGATION AND IS CURRENTLY UNAVAILABLE FOR INVESTIGATION. UPON COMPLETING THE LITIGATION THE UNIT WILL BE RELEASED TO THE MFR OR DISTRIBUTOR FOR FURTHER EVAL AND INVESTIGATION.
PRELIMINARY INVESTIGATION BY THE FIRE MARSHALL AND TEH CRIME LAB REVEALED THAT THE DEVICE WAS FUNCTIONAL AT THE TIME OF THE INVESTIGATION. THE SYSTEM IS BEING HELD PENDING LITIGATION AND IS CURRENTLY UNAVAILABLE FOR INVESTIGATION BY THE DISTRIBUTOR AND THE MFR. THE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. THE PRELIMINARY FIRE MARSHALL REPORT IS ATTACHED. SHOULD THE SYSTEM BE RETURNED, AN EVAL WILL BE PERFORMED AND THE RESULTS WILL BE SUBMITTED IN AN ADD'L INFO REPORT.
PRELIMINARY INVESTIGATION BY THE FIRE MARSHALL AND THE CRIME LAB REVEALED THAT THE DEVICE WAS FUNCTIONAL AT THE TIME OF THE INVESTIGATION. THE SYSTEM IS BEING HELD PENDING LITIGATION AND IS CURRENTLY UNAVAILABLE FOR INVESTIGATION BY THE DISTRIBUTOR AND THE MFR. THE CUASE OF THE EVENT HAS NOT BEEN DETERMINED THE PRELIMINARY FIRE MARSHALL REPORT IS ATTACHED. SHOULD THE SYSTEM BE RETURNED, AN EVAL WILL BE PERFORMED AND TEH RESULTS WILL BE SUBMITTED IN AN ADD'L INFO REPORT.
INITIAL BILATERAL IMPLANTATION WAS ON 6/14/84. LAWSUIT FILED FOR UNDISCLOSED "DAMAGES."
JOURNAL ARTICLE REFERENCING CASE REPORTS OF TWO PTS. CASE 1: THE PT HAS A POSTERIOR STABILIZED KNEE PROSTHESIS IMPLANTED ON 9/9/90. NINE MONTHS POST-OP, (6/91) THE PT PRESENTED WITH THE INABILITY TO EXTEND THE RIGHT KNEE. POSTERIOR DISLOCATION WAS DIAGNOSED AND CLOSED REDUCTION WAS PERFORMED UNDER GENERAL ANESTHESIA. THE PT DISLOCATED POSTERIORLY AGAIN IN 1/92 WHEN CLOSED REDUCTION OF THE DISLOCATIONS WAS PERFORMED. AS OF 7/94, THE PT HAS HAD NO FURTHER DISLOCATIONS.
INFO HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. USER FACILITY IS UNKNOWN.
UNSUBSTANTIATED LEGAL COMPLAINT WAS REC'D WHICH ALLEGES THAT PLAINTIFF ACQUIRED PROSTHESES, THAT PRODUCT WAS "DEFECTIVE", AND THAT THE "DEFECTIVE" PRODUCT CAUSED PHYSICAL DAMAGE TO PLAINTIFF.
AS THE PROSTHESES WERE NOT RETURNED NO PHYSICAL EVAL WAS POSSIBLE, AND NO CONCLUSION COULD BE DRAWN. THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CUI THAT THE REPORT OR INFO THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. REPORTS ARE BASED ON INFO THAT IS SUPPLIED TO CUI CORP WITHOUT OUR INDEPENDENT VERIFICATION AS TO ITS ACCURACY OR COMPLETENESS. IT IS UNDERSTOOD THE INFO MAY NOT REPRESENT FACT AFTER INVESTIGATION. CUI CORPORATIONS APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. FILING A MDR PURSUANT TO 21 CFR, PART 803.16 DOES NOT CONSTITUTE AN ADMISSION BY CUI CORP THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. CUI CORP DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVAL CODES ARE NECESSARILY AN ACCURATE REFLECTION OF THE RESULTS AND CONCLUSIONS OF THE DEVICE EVAL. CUI CORP CONSIDERS THE INFO PROVIDED IN THIS REPORT TO BE HIGHLY CONFIDENTIAL, THEREFORE CO REQUESTS THAT FDA PROTECT IT FROM ANY FOIA REQUEST.
PT WITH PNEUMONIA AND EMPYEMA. AFTER INTUBATION, CHEST TUBE WAS INSERTED WITH SUBSEQUENT PULMONARY HEMORRHAGE.
INITIAL BILATERAL IMPLANTATION IN 1976. CONSUMER FURTHER REPORTS VARIOUS ILLNESES INCLUDING, BUT NOT LIMITED TO, SWOLLEN NODES, GALLBLADER AND INTESTINE PROBLEMS, RUPTURE AND RASHES.
DEATH APPROX 10 HRS S/P MITRAL VALVE REPLACEMENT. SURGERY WAS UNEVENTFUL. 8 HRS LATER, BEGAN TO SHOW INTERMITTENT LACK OF PERFUSION WITH EKG RHYTHM. A DECISION WAS MADE TO RETURN THE PT TO THE OR AS A VALVE MALFUNCTION WAS SUSPECTED, HOWEVER, PT ARRESTED AND EXPIRED BEFORE THIS WAS ACCOMPLISHED.
JOURNAL ARTICLE REFERENCING CASE REPORTS OF TWO PTS. CASE 2: THE PT HAS A POSTERIOR STABILIZED KNEE PROSTHESIS IMPLANTED IN 1/91. FOUR MONTHS POST-OP (MAY 1991) THE PT PRESENTED WITH SWELLING AND THE INABILITY TO EXTEND THE RIGHT KNEE. POSTERIOR DISLOCATIONS WAS DIAGNOSED AND CLOSED REDUCTION WAS PERFORMED UNDER GENERAL ANESTHESIA. THREE YEARS POST REDUCTION. THE PT HAS HAD NO FURTHER DISLOCATIONS.
THE DEVIES DESCRIBED IN THE ARTICLE CAN NOT BE EVALUATED FOR THE REPORTER POSTERIOR DISLOCATIONS THEY HAVE NOT BEEN RETURNED TO CO. THE LOT CODES HAVE NOT BEEN RETURNED TO CO. THE LOT CODES HAVE NOT BEEN SUPLLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE, CATALOG NUMBERS, AND LOT CODE INFORMATION HAVE BEEN UNSUCCESSFUL. INFORMATION HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFORMATION HAS BEEN REQUESTED. IF INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. USER FACILITY IS UNK.
PT UNDERGOING CARDIAC CATHETERIZATION. RIGHT HEART CATHETERIZATION PERFORMED WITHOUT INCIDENT. A 7FR MULTIPURPOSE CATHETER WAS THEN ADVANCED TO ASCENDING AORTA. AN ATTEMPT TO CROSS THE AORTIC VALVE RETROGRADE WAS UNSUCCESSFUL. SUDDENLY THE PT BECAME PROFOUNDLY HYPOTENSIVE; SHE ARRESTED, AND DESPITE VIGOROUS EFFORTS, SHE EXPIRED.
REVISION SURGERY REVEALED LOOSENING OF THE HIP STEM. AN ACETABULAR INSERT WAS ALSO REVISED AS A PRECAUTION DURING THIS SURGERY.
INFO HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THE ARRHYTHMIA MONITORING SYSTEM DID NOT ALARM PROPERLY. THEY FELT THERE SHOULD HAVE BEEN A THREE STAR ALARM BEFORE THE PT WENT INTO ASYSTOLE.
CO REP WENT TO THE SITE AND DID A FULL TEST OF THE ARRHYTHMIA ALARM SYSTEM. THE SYSTEM WORKED AS DESIGNED AND IS STILL IN USE AT THE HOSP. IT APPEARS THAT THE NURSING STAFF DOESN'T HAVE AN UNDERSTANDING OF THE "REFRACTORY" PERIOD WHEN AN ALARM HAS BEEN AUTO-RESET. THE SYSTEM DID INDICATE THAT THE PT WAS IN DISTRESS AND REQUIRED INTERVENTION, BUT AUTO RESET MEANS THE ALARMS WERE IGNORED. CO CLINICAL SPECIALIST WILL BE IN CONTACT WITH THE CUSTOMER TO TRAIN THEIR NURSING STAFF.
THE EVENTS WITH THE VENTILATOR AUTOCYCLING OCCURRED ON 8/1/96 OR 8/2/96 AT 6:00 P.M. ON 8/1/96. THE SETTING ON THE VENTILATOR AT THE START OF THE EVENT WAS, SET RATE 12, VT 700CC, PS+8 CMH20, PRESSURE TRIGGER AT -1CMH20. THE ACTUAL RATE WAS 28 B/M WITH THE PT EFFORT LIGHT ACTIVATING WITH EVERY BREATH. ABG'S WERE DRAWN WITH THE FOLLOWING RESULTS: PH 7.72, PC02 16 AND A GOOD P02. RPTR STATED THAT THEY THEN PARALYZED THE PT TO STOP THE HYPERVENTILATION. THE VENTILATOR CONTINUED TO TRIGGER AFTER THE PT WAS PARALYZED. THEY EXCHANGED VENTILATORS AND PLACED THE PT ON ANOTHER VENTILATOR. UPON CLOSE INSPECTION FOUND A HOLE IN THE EXHALATION VALVE DIAPHRAGM.
USING A DISPOSABLE STANDARD 72 INCH CIRCUIT THE SELF DIAGNOSTIC TESTING PASSED WITHOUT ANY PROBLEMS. IN ALL CASE WITH AUTOCYCLING PRESENT, USING VARIABLE SIZE HOLES IN THE EXHALATION VALVE DIAPHRAGM THE SELF TEST DETECTED THE HOLE AND FAILED THE D7 PRESSURE TEST. HOWEVER THE D7 TEST WOULD PASS WITH THE PRESENCE OF SMALL HOLE IN THE EXHALATION VALVE DIAPHRAGM BUT WITH NO AUTOCYCLING. TESTING PERFORMED WITHOUT PEEP SHOWED NO AUTOCYCLING. AUTOCYCLING CAN OCCUR IN THE PRESENCE OF A LEAK IN THE CIRCUIT AND WITH A HOLE IN THE EXHALATION VALVE DIAPHRAGM. THIS EVENT MOST LIKELY OCCURRED DUE TO THE HOLE IN THE EXHALATION VALVE DIAPHRAGM ALONG WITH AN ADDITION LEAK IN THE PT CIRUIT AND OR AROUND THE PT'S AIRWAY. IN MOST CASES THE D7 SELF TEST WILL DETECT HOLES IN THE EXHALATION VALVE DIAPHRAGM THAT ARE LARGE ENOUGH TO CAUSE AUTOCYCLING.
REVISION SURGERY REVEALED POLYURETHANE WEAR OF THE TIBIAL INSERT.
REMOVAL OF CAPSULE LEFT BREAST, REMOVAL LEFT SALINE IMPLANT.
A 66-YR-OLD WITH BILATERAL CAPSULAR CONTRACTURE. LIKELY SECONDARY TO RUPTURE. SYMPTOMATIC WITH RESPECT TO PAIN. SURGERY APPROX 20 YEARS AGO.
REVISION SURGERY REVEALED LOOSENING OF THE PATELLA AND POLYETHYLANE WEAR OF THE TIBIAL INSERT. DUE TO INSUFFICIENT PATELLA BONE STOCK, THE PATELLAR COMPONENT WAS NOT REPLACED.
SUMMARY OF EVALUATION: THE TIBIAL AND PATELLAR COMPONENTS CNA NOT BE EVALUATED FOR THE REPORTED WEAR OF THE INSERT OR LOOSENING OF THE PATELLAR COMPONENT AS THEY HAVE NOT BEEN RETURNED TO HOWMEDICA BUT RATHER HAVE BEEN RETAINED BY THE PT. A REVIEW OF THE DEVICE RECORD FOR THE PATELLAR COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE LOT CODE FOR THE TIBIAL INSERT HAS NOT BEEN SUPPLIED SO THAT THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ATTEMPTS TO OBTAIN THE LOT CODE INFO FOR THE TIBIAL INSERT HAVE BEEN UNSUCCESSFUL. SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THE LENS BROKE THE CAPSULE WHEN UNFOLDED IN THE EYE. THE INCISION WAS ENLARGED FROM 3.5 MM AND THE LENS WAS REMOVED. IT IS UNKNOWN IF A VITRECTOMY WAS PERFORMED (ACCOUNT COULD NOT PROVIDE INFO) AS A RESULT OF THE BROKEN CAPSULE.
F8: NA- MFR DID NOT RECEIVE A MEDWATCH REPORT FROM USER FACILITY. F10: PATIENT CODE: (CORRECTED) 2200 (OTHER) - INCISION ENLARGEMENT, UNLABELED. F10: DEVICE CODE: 1766, LABELED. H3: PRODCUT EVALUATION RESULTS: EVIDENCE OF SURGICAL RESIDUE. ONE OF THE HAPITCS IS TWISTED AND ONE HAPTIC IS BENT.
THE PT WAS ADMITTED TO THE HOSP FOR REMOVAL OF BILATERAL BREAST IMPLANTS. THE PT WAS NOTED TO HAVE BILATERAL BREAST DEFORMITIES SECONDARY TO RUPTURED BREAST IMPLANTS WITH CAPSULAR CONTRACTURES. THE IMPLANTS WERE ORIGINALLY INSERTED IN 1982.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PORTUSION. NO FURTHER INJURY OR COMPLICATIONS ASSOCIATED WITH THE EVENT.
CHILD WAS JUMPING IN BED AND CLIMBED ON SIDE RAIL WHEN IT DROPPED AND PINCHED HER FOOT. AGE AT TIME OF EVENT: 5 YR 7 MO.
REVISION SURGERY REVEALED POLYURETHANE WEAR OF THE PATELLA AND TIBIAL INSERT.
SUMMARY OF EVALUATION: DEVICE WAS NOT RETURNED, UNABLE TO EVALUATE. THE POLICY OF THE HOPSITAL IS TO RETAIN THE DEVICE FOR 2 YEARS FROM DATE OF EVENT.
VENOUS ACCESS IMPLANTED. CATHETER AND PORT BECAME DISCONNECTED FROM ONE ANOTHER, LEAVING THE CATHETER FREE FLOATING IN THE SUPERIOR VENA CAVA. PORT REMOVED BY FLUOROSCOPY. NO RESIDUAL KNOWN DAMAGE TO THE PT.
IMPLANT WAS PLACED ON 4/11/96. UPON UNCOVERING IT WAS NOTED THAT 3 IMPLANTS WERE LOOSE AND HAD NEVER INTEGRATED. THE 4TH IMPLANT IS STILL IN.
RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. THE PT'S SMOKING IS THE LIKELY CAUSE OF FAILURE. THIS REPORT IS LATE DUE TO COMPUTER/SOFTWARE PROBLEMS.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. NO FURTHER INJURY OR COMPLICATIONS ASSOCIATED WITH THE EVENT.
THE PT EXPERIENCED PAIN AFTER SUSTAINING A CAR ACCIDENT IN 1995. REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLAR COMPONENT. IMPLANT DATE: 1986.
SURGEON INSERTED LENS IN PT'S EYE AND NOTED WHAT APPEARED TO BE A BUBBLE OR PIT IN THE CENTER OF THE LENS. THE INCISION WAS ENLARGED FOR REMOVAL OF THE LENS.
F10: PATIENT CODE - 2200 (OTHER), INCISION ENLARGMENT, UNLABLED. F10: DEVICE CODE - 1070, BUBBLE, UNLABELED. H3: EVALUATION RESULTS - THE LENS OPTIC WAS SPLIT IN FOUR PLACES ON THE POSTERIOR SURFACE. ONE OF THE SPLITS APPEARED TO BE REFLECTIVE IN NATURE, WHICH MIGHT EXPLAIN THE OBSERVATION OF A PIT OR BUBBLE IN THE CENTER OF THE LENS.
IMPLANT WAS PLACED ON 6/17/96, SITE #31. IT NEVER INTEGRATED. PT HAS NO HEALTH PROBLEMS OTHER THAN A HEART MURMUR.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. IT HAD SOME BONY TISSUE IN THE CUTTING FLUTES AND EXTERNAL THREADS. THE PT'S INFECTION IS THE LIKELY CAUSE OF FAILURE.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. THERE WAS A BROWNISH-WHITE RESIDUE ON THE EXTERNAL SURFACE OF THE IMPLANT. THE REPORTED INFECTION IS THE LIKELY CAUSE OF FAILURE. THIS REPORT IS BEING SUBMITTED LATE DUE TO COMPUTER/SOFTWARE PROBLEMS.
ONE PERSON AFFECTED. IS NOT ON FILE FOR TEXT COPY.  ENTER TEXT.
REVISION SURGERY WAS PERFORMED DUE TO RUPTURE OF THE PATELLA TENDON. AS A RESULT, THE PATELLA COMPONENT WAS REMOVED AND NOT REPLACED. REVISION SURGERY ALSO REVEALED DELAMINATION OF THE POLYETHYLENE TIBIAL INSERT.
INFO HAS BEEN PROVDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
THE DR INSERTED THE LENS DELIVERY CARTRIDGE INTO THE EYE AND UPON ADVANCING THE PLUNGER, THE LENS TORE PROXIMAL TO THE OPTIC ON THE TRAILING HAPTIC. AND INCISION ENLARGMENT FROM 3.5 MM TO APPROX 5.0 MM WAS REQUIRED TO REMOVE THE LENS.
F8: NA - MFR DID NOT RECEIVE A MEDWATCH REPORT FROM THE USER FACILITY. F10: PATIENT CODE (CORRECTED) - 2200 (OTHER) INCISION ENLARGEMENT, UNLABELED. F10: DEVICE CODE - 1628, UNLABELED. G4: INFORMATION CORRECTED TO DATE THAT MFR RECEIVED INFORMATION THAT MADE THE COMPLAINT "REPORTABLE".
FRACTURED FIXTURE. IT HAS BEEN REPORTED THAT AN IMPLANT HAS FRACTURED. PT INJURY HAS NOT BEEN REPORTED.
IMPLANT FAILED. DATE OF OCCURRENCE UNKNOWN.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. THE PT'S SMOKING, AS WELL AS THE CLENCHING REQUIRED TO HOLD A PIPE, IS LIKELY CAUSE OF FAILURE. THIS REPORT IS SUBMITTED LATE DUE TO COMPUTER/SOFTWARE PROBLEMS.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT.
INFO HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVAL: THE TIBIAL INSERT AND BASEPLATE CAN NOT BE EVALUATED AS THEY HAVE NOT BEEN RETURNED TO CO BUT RATHER HAVE BEEN RETAINED BY THE PT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE AS THE LOT CODES HAVE NOT BEEN PROVIDED. ATTEMPTS TO OBTAIN LOT CODE INFO HAVE BEEN UNSUCCESSFUL.
THE LENS DID NOT FULLY RELEASE FROM THE CARTRIDGE CAUSING THE SURGEON TO WITHDRAW THE DEVICE FROM THE EYE WITH THE LENS STILL ATTACHED TO THE INSERTER TIP. THE INCISION WAS ENLARGED RELATED TO THE EVENT FOR INSERTION OF A PMMA STYLE LENS.
A2-4: PATIENT AGE/DATE OF BIRTH/WEIGHT/SEX NOT PROVIDED BY USER FACILITY TO INTERNATIONAL AFFILIATE. D5: UNABLE TO DETERMINE EXPIRATION DATE BECAUSE ACCOUNT WAS NOT ABLE TO PROVIDE LOT NUMBER OF THE DEVICE. D6: ACCOUNT WAS NOT ABLE TO PROVIDE LOT NUMBER OF THE DEVICE. E1: INTERNATIONAL FACILITY, NO AREA CODE. H4: UNABLE TO DETERMINE MFR DATE BECAUSE ACCOUNT WAS NOT ABLE TO PROVIDE LOT NUMBER OF THE DEVICE. H3: PRODUCT EVALUATION RESULTS: INSERTION DEVICE WAS NOT RETURNED FOR EVALUATION. EVALUATION OF THE RETURNED LENS SHOWED THAT THERE WAS NOT DAMAGE TO THE LENS.
DURING CARDIAC CATHETERIZATION, CATHETER COULD NOT BE REMOVED FROM PT BECAUSE IT HAD BECOME ENTRAPPED BY ARTERIAL SHEATH. UPON EXAMINING ARTERIAL SHEATH, THE DISTAL END OF ARTERIAL SHEATH HAD  MULTIPLE AREAS OF INFOLDING WHICH CAUSED TRAPPING OF CATHETER. THE DISTAL END OF SHEATH DUE TO INFOLDINGS WAS A POTENTIAL FOR BREAKING INSIDE OF ARTERY.
THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OF CULPABILITY FOR ANY AND/OR ALL ASPECTS OF THIS EVENT, AND MAY BE BASED UPON INCOMPLETE AND/OR UNSUBSTANTIATED INFO.
THE PT EXPERIENCED PAIN. X-RAY REVEALED TWO BEADS LOOSENED FROM THE BASEPLATE. AS A RESULT, THE TIBIAL BASEPLATE WAS REVISED. THE TIBIAL INSERT WAS ALSO REMOVED INCIDENTALLY TO THE BASEPLATE AT THIS TIME.
ONE IMPLANT WAS PLACED ON 6/17/96. PT CAME IN WITH IMPLANT IN HER HAND ON 8/1/96. NO INFECTION/NO INTEGRATION. PT IS A SMOKER. NO OTHER HEALTH PROBLEMS.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. THE LIKELY CAUSE OF FAILURE IS THE REPORTED INFECTION, COMPOUNDED BY THE PT'S SMOKING.
THE TIBIAL INSERT WOULD NOT SEAT IN THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT. THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY DUE ONLY TO A REPORTED EXTENSION OF SURGERY TIME.
THE RUBBER CAME OFF A CASTER ON HIS MANUAL WHEELCHAIR AND LEAD TO THE CHAIR TIPPING OVER. THE USER CLAIMS TO HAVE BEEN TREATED FOR A BLOOD CLOT AND BRUISES.
ONE IMPLANT PLACED 5/196. REMOVED 7/19/96. PT HAS HAD PRIOR IMPLANTS-SOME INTEGRATED AND OTHERS DID NOT. PT IS A RECOVERING ALCOHOL AND COCAINE ABUSER AND PAST SMOKER.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. IT HAD BROWNISH-WHITE RESIDUE ON THE EXTERNAL SURFACE. THE CAUSE OF FAILURE IS LIKELY THE PT'S GENERAL HEALTH(A RECOVERING ALCOHOL AND SUBSTANCE ABUSER), WHICH MAY HAVE PREVENTED THE SURGERY FROM HEALING AS WELL AS IT SHOULD HAVE.
IMPLANT WAS PLACED 4 MONTHS AGO. DR STARTED TO NOTICE A RADIOLUCENCY AT 2 MONTHS POST-OP. 6 WEEKS AGO, PT'S JAW WAS FRACTURED. IMPLANT WAS REMOVED AND 2 PLATES PUT IN TO STABILIZE.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATONS. THE IMPLANT FAILED DUE TO THE PT'S JAW BEING BROKEN.
IMPLANTS WAS PLACED 4 MONTHS AGO. DR STARTED TO NOTICE A RADIOLUCENCY AT 2 MONTHS POST-OP. 6 WEEKS AGO, PT'S JAW WAS FRACTURED. IMPLANTS WERE REMOVED AND 2 PLATES PUT IN TO STABILIZE.
THE RETURNED IMPLANTS WERE FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. THE LIKELY CAUSE OF FAILURE IS TH PT'S JAW BEING BROKEN.
IMPLANT WAS PLACED 7 MONTHS AGO IN THE MAXILLA. WHEN DR DID TRY-IN OF THE COC ABUTMENT, THE IMPLANT AND ABUTMENT BOTH CAME OUT. IMPLANT WAS NOT INTEGRATED.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
IT WAS REPORTED THAT AN IMPLANT HAD TO BE REMOVED DUE TO INABILITY TO GET COVER SCREW TO THREAD INTO INTERNAL CHAMBER AT TIME OF SURGERY. IMPLANT WAS REMOVED DURING SAME SURGERY. NO PT INJURY HAS BEEN REPORTED.
IMPLANT WAS PLACED 6 MONTHS AGO. NO SIGN OF ANY PROBLEMS. DURING TRANSFER, IMPLANT CAME LOOSE. DATE OF OCCURRENCE UNKNOWN.
THE RETURNED IMPLANT MEETS SPEICIFICATIONS. THERE IS SOME BONY TISSUE IN THE APICAL HOLES. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
IMPLANT WAS PLACED ON 6/26/96. REMOVED 1 WK LATER DUE TO INFECTION.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. THE PT'S REPORTED INFECTION IS THE LIKELY CAUSE OF FAILURE.
LEFT FRONT WHEEL OF WHEELCHAIR CAME OFF, THROWING PT TO FLOOR. HIT BACK OF HEAD ON REFRIGERATOR, BRUISED RIGHT HAND, BRIDGE OF NOSE AND LEFT EYE. BROKE GLASSES. SHALLOW LACERATION BRIDGE OF NOSE. USED LIFELINE TO CALL FOR ASSISTANCE. PT HAD PLACED SKILLET WITH OLEO ON BURNER PRIOR TO INCIDENT. PT WAS UNABLE TO REACH BURNER TO TURN IT OFF. HOUSE WAS FILLED WITH SMOKE WHEN HELP ARRIVED.
PA CATHETER THERMO CONNECTION HAD DEFECTIVE WIRES THAT WERE NOT INTACT. PA CATHETER REPLACED WITH NO EFFECT ON PT.
MFR REC'D A REPORT OF A USER FALLING AS A RESULT OF A WALKER ADJUSTMENT PIN MALFUNCTION. THIS INCIDENT ALLEGEDLY LEAD TO THE USER REINJURING HER ANKLE.
IT HAS BEEN REPORTED THAN ABUTMENT SCREW FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
THE PORT WAS BELIEVED TO HAVE BEEN IMPLANTED IN THE PT IN 12/95. THE PORT WAS REMOVED IN 8/96 DUE TO CATHETER BREAKAGE AND EMBOLIZATION.
IT HAS BEEN REPORTED THAT ABUTMENT SCREW FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
THE DEVICE WAS REMOVED AS IT WAS "NON-FUNCTIONING". 8/29/96-UPON RECEIPT OF THE EXPLANTED PENILE PROSTHESIS FROM THE HOSPITAL ON 8/29/96, THE DEVICE WAS REMOVED DUE TO "NON-FUNCTION" AS WELL AS "EROSION". CO'S OFFICE IS IN RECEIPT OF THE CYLINDER(S) AND PUMP COMPONENT(S) ONLY.
EVAL. IS PENDING DECONTAMINATION, TESTING AND EXAMINATION OF THE RETURNED DEVICE COMPONENT(S). FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL. WILL BE FORWARDED UPON COMPLETION.
THE PORT WAS "DEFFECTIVE." THE PORT WAS REMOVED OVER THE WEEKEND AND THE ORIGIAL REPORTER DID NOT KNOW WHAT PROBLEM CAUSED THE PORT TO BE REMOVED.
THE IMPLICATED PRODUCT IS A 12.0 FR. DUAL LUMEN CATHETER IN A BASIC TRAY. THE PRODUCT RECEIVED FOR EVALUATION IS THE PROXIMAL SEGMENT OF A 12.0 FR. DUAL LUMEN CATHETER MEASURING 22.4 INCHES LONG AND A SECOND DUAL LUMEN SEGMENT MEASURING 3.4 INCHES LONG. NO CUFF IS PRESENT ON EITHER SEGMENT, HOWEVER, THE PROXIMAL SEGMENT CONTAINS AN AREA OF SILICONE ADHESIVE RESIDUE LOCATED BETWEEN 15.4 AND 15.65 INCHES FROM THE PROXIMAL END. THE DISTAL TIP OF THE PROXIMAL SEGMENT IS IRREGULAR AND BROKEN. ONE END OF THE SECOND TUBING ALSO HAS A ROUGH, IRREGULAR EDGE WHILE THE OPPOSING END IS RELATIVELY EVEN AND TERMINATES IN AN ABRUPT ANGLE. A LOT HISTORY REVIEW IS NOT POSSIBLE AS NO LOT NUMBER HAS BEEN PROVIDED. THE COMPLAINT FILE INCLUDES AN INTER-OFFICE MEMORANDUM DATED 2-12-96 INDICATING THE DEVICE HAD BEEN IN PLACE APPROX. 3 MONTHS WHEN THE COMPLAINT INCIDENT OCCURRED DURING ROUTINE FLUID ADMINSTRATION. NO INFO IS PROVIDED REGARDING ANY PREVIOUS PROBLEMS WITH INFUSION OR ASPIRATION. A "SPLIT" WAS CONFIRMED BY FLUOROSCOPY WITH SUBSEQUENT SURGICAL INTERVENTION TO REMOVE THE PROXIMAL SEGMENT AND SNARE THE DISTAL FRAGMENT. THE MEMO ALSO STATES "THE DR.'S BELIEVE IT MAY HAVE OCCURRED DUE TO 'PINCH-OFF..." TACTUAL EXAM IS REMARKABLE FOR OCCLUSION CLAMP IMPRESSIONS IN THE PROXIMAL SEGMENT AND AN IRREGULAR ANNULAR RING IN THE LOOSE PIECE. THIS RING MAY BE THE RESULT OF THE INSTRUMENT USED TO RETRIEVE THE EMBOLIZED TUBING. PATENCY OF BOTH LUMENS OF EACH SEGMENT IS CONFIRMED BY FLUSHING AND ASPIRATING WATER WITH A 12CC SYRINGE. NO LEAKS ARE NOTED AS EACH LUMEN IS INDIVIDUALLY OCCLUDED AND HYDRAULICALLY PRESSURIZED TO SUSTAINED PRESSURES GREATER THAN 25PSI. UNDER 7X MICROSCOPIC EXAM, A COMPARISON OF THE BROKEN ENDS OF THE INDIVIDUAL SEGMENTS IS MADE. A MATCH IS EVIDENT, IDENTIFYING THE SHORTER SEGMENT AS THE DISTAL PORTION OF THE CATHETER. TEN POWER MAGNIFICATION OF THE TUBING ENDS REVEALS THE DISTAL TIP OF THE PROXIMAL SEGMENT AND THE PROXIMAL END OF THE DISTAL SEGMENT TO HAVE BROKEN, IRREGULAR EDGES AND ROUGH, UNEVEN FACES. THIS SUGGESTS BLUNT TRAUMA SEVERED THE TUBING. THE DISTAL TIP OF THE DISTAL SEGMENT IS REGULAR WITH A FLAT, STRIATED SURFACE INDICATING IT WAS CUT WITH A SHARP INSTRUMENT SUCH AS A SCALPEL. EXCEPT FOR THE ABSENCE OF A SURECUFF AND SILICONE ADHESIVE RESIDUE ON THE PROXIMAL SEGMENT, THE OUTER DIAMETER OF BOTH PORTIONS OF TUBING IS UNREMARKABLE. A MICROSCOPIC MICROMETER IS USED TO MEASURE THE CROSS-SECTIONAL OUTER DIAMETER OF THE TUBING SEGMENTS' BROKEN ENDS. THE TWO AXES OF THE PROXIMAL SEGMENT'S DISTAL TIP ARE .160 X .150 INCHES. THE TWO AXES OF THE DISTAL SEGMENT'S PROXIMAL END ARE .155 X .149 INCHES. THE AVERAGE OUTER DIAMETER MEASUREMENT FOR 12.0 FR. DUAL LUMEN TUBING AS ESTABLISHED BY THE MFR IS .157 INCHES. THE COMPLAINT OF CATHETER BREAKAGE AND EMBOLIZATION IS CONFIRMED. IT SHOULD BE RECORDED AS USER-RELATED. THE FACT THAT THE DEVICE HAD BEEN IN PLACE AND FUNCTIONAL FOR NEARLY THREE MONTHS COMBINED WITH THE EVIDENCE OF BLUNT TRAUMA SUGGESTS
THE DEVICE WAS IMPLANTED ON 10/3/95 FOR INFUSION OF CHEMOTHERAPY. ON 8/6/96, THE MFR'S FRENCH DISTRIBUTOR CONTACTED THE MFR TO REPORT AN INCIDENT WHICH HAD OCCURRED AT A FACILITY IN THEIR TERRITORY. THE REPORT STATES THAT THE FRENCH MINISTRY OF HEALTH HAD REC'D NOTICE OF AN INCIDENT INVOLVING DEVICE CATHETER BREAKAGE. THE ONCOLOGIST OBSERVED THE DEVICE CATHETER BREAKAGE ON 6/13/96, DURING AN X-RAY CONTROL. THE EXPLANTED DEVICE IS EXPECTED TO BE FORWARDED TO THE DISTIBUTOR, WHO WILL THEN FORWARD IT TO THE MFR FOR ANALYSIS. THE MFR HAS NOT REC'D THE DEVICE TO DATE.THE MINISTRY OF HEALTH HAS REQUESTED A REPORT CONCERNING THE PREVENTATIVE MEASURES, AS WELL AS CURATIVE TO BE TAKEN. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. EXPIRATION DATE: 5/2/00.
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR; THEREFORE, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD FOR THIS CATALOG/LOT NUMBER. A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CATALOG/LOT NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CATALOG/LOT NUMBER AND NO MFG VARIANCES WERE  IDENTIFIED IN RELATION TO THIS EVENT. BASED ON THE AVAILABLE INFO, AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE MFR HAS INFORMED THE DISTRIBUTOR THAT IT WOULD BE NECESSARY TO PERFORM AN ANALYSIS ON THE DEVICE LABELING AND A PORTION OF THE DEVICE CLINICIAN'S MANUAL WHICH CONTAIN DEVICE CATHETER PLACEMENT WARNINGS. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
DURING CATHETER PLACEMENT, THE NURSE LOOKED AWAY AND THE CATHETER EMBOLIZED IN THE PT'S ARM. THE SUTURE WING HAS NOT BEEN PLACED ON THE CATHETER WHEN THIS OCCURRED. THE PT WAS TAKEN TO RADIOLOGY WHERE THE CATHETER WAS SNARED OUT.
THE DEVICE WAS REMOVED DUE TO A "LEAK". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 2-PIECE INFLATABLE.
EVAL AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE. AT THIS TIME, THE DEVICE HAS NOT BEEN MADE AVAILABLE AND THERE HAS BEEN NO ADD'L INFO RECEIVED TO ELABORATE ON THE CAUSE AND NATURE OF THIS OCCURRENCE. THEREFORE, QA IS PRECLUDED FROM COMMENT ON THE CONDITIN OF THE DEVICE AND ITS CONTRIBUTION TO THIS OCCURRENCE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. IF ADD'L INFO AND/OR THE DEVICE BECOME AVAILBLE, QA WILL PROVIDE AND ADDENDUM AS REQUIRED.
TIP OF SCREWDRIVER BROKE OFF AND REMAINED LODGED IN HEAD OF SCREW WHICH WAS IMPLANTED IN THE PT.
REVISION SURGERY REVEALED POLYETHLENE WEAR OF THE PATELLA AND TIBIAL INSERT.
DR. REPORTED WHILE PLACING IMPLANT SITE WAS ENLARGED. DR. GRAFTED THE SITE. DR DID NOT PLACE IMPLANT AT THAT TIME.
THE DEVICE WAS REMOVED DUE TO A "FLUID LOSS". ADDITIONALLY, IT WAS REPORTED THAT THE PT WAS "UNHAPPY WITH THE IMPLANT HE HAD IMPLANTED APPROX. ONE YR AGO". THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 3-PIECE INFLATABLE.
TWO CYLINDERS AND A PUMP WERE RECEIVED BY THE MANUFACTURER. DURING FUNCTIONAL TESTING, A LEAK WAS OBSERVED IN THE NON-SERIALIZED STRAIN RELIEF JUNCTION OF THE PUMP. NO OTHER ANOMALIES WITH THE CYLINDERS OR PUMP WERE DETECTED DURING FUNCTIONAL TESTING. MICROSCOPIC EXAMINATION OF THE ANOMALY SITE REVEALED THAT THE OUTER LAYER OF TUBING WAS APPARENTLY WORN AWAY. THE INNER LAYER OF TUBING WAS SEPARATED. EVIDENCE OF ABRASION, INDICATED BY UNUSUALLY SHINY MATERIAL, IS LOCATED POSTERIORLY FROM THE SEPARATION ANTERIOR TO THE SEPARATION, TWO PORTIONS OF MONOFILAMENT WERE EXPOSED. THE MOST POSTERIOR EXPOSED MONOFILAMENT WAS DEFORMED, INDICATING STRESS(ES) ON THE STRAIN RELIEF JUNCTION. A CREASE MARK IN THE TUBING BETWEEN THE EXPOSED MONOFILAMENT WAS NOTED. AS RECEIVED, THE TUBING WAS BENT TOWARD THE SEPARATION, INDICATING THAT THE TUBING WAS BENT FOR A LONG PERIOD OF TIME. BASED ON THE PHYSICIAN'S OBSERVATIONS AND QUALITY ASSURANCE'S EXAMINATION, QA CONCLUDED THAT WHILE IN-VIVO THE TUBING OF THE NON-SERIALIZED STRAIN RELIEF WAS BENT BACK ON ITSELF, AND ABRADED AGAINST ITSELF. THIS ABRADING WORE THROUGH THE OUTER LAYER OF TUBING. WITH THE TUBING IN THIS WEAKENED STATE, STRESS(ES) MAY HAVE STRETCHED THE TUBING, CAUSING THE MONOFILAMENT TO BE DEFORMED AND CAUSING THE INNER LAYER OF TUBING TO SEPARATE. QA FURTHER CONCLUDED THAT THE REPORTED "FLUID LEAK" RESULTED FROM THIS SEPARATION.
BROKE OFF AT ENTRY OF CONNECTION TO MAIN PORT.
REVISION SURGERY REVEALED LOOSENING OF THE PATELLA AND POLYURETHANE WEAR OF THE TIBIAL INSERT. DUE TO INSUFFICIENT PATELLA BONE STOCK, THE PATELLAR COMPONENT WAS NOT REPLACED.
SUMMARY OF EVALUATION: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR OF THE INSERT OR LOOSENING OF THE PATELLAR COMPONENT AS THEY HAVE NOT BEEN RETURNED TO HOWMEDICA BUT RATHER HAVE BEEN RETAINED BY THE PT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PATELLAR COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANFACTURE. THE LOT CODE FOR THE TIBIAL INSERT HAS NOT BEEN SUPPLIED SO THAT THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ATTEMPTS TO OBTAIN THE LOT CODE INFO FOR THE TIBIAL INSERT HAVE BEEN UNSUCCESSFUL. SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
AN ABUTMENT BROKE IN FUNCTION. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-00013.
END OF TUBING WAS SMASHED; OVAL SHAPED AND WOULD NOT FIT INTO INTRAVENOUS CATHETER.
THE DEVICE WAS REMOVED DUE TO "FAILURE OF THE PUMP AND CYLINDER(S)". THE PUMP, CYLINDER(S) AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED WITH ANOTHER 3 PIECE INFLATABLE.
EVAL IS PENDING DECONTAMINATION, EXAMINATION AND TESTING OF THE RETURNED DEVICE COMPONENT(S). FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL. WILL BE FORWARDED UPON COMPLETION.
TIP BROKE OFF DURING CERVICAL DISC SURGERY. BROKEN PIECE WAS RECOVERED WITHOUT DIFFICULTY. BREAKAGE PROBABLY DUE TO AGE OF EQUIPMENT.
THE PT EXPERIENCED PAIN AFTER SUSTAINING A CAR ACCIDENT IN 1995. REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLAR COMPONENT.
TIP BROKE OFF DURING CERVICAL DISC REPAIR. BOTH PIECES WERE RETRIEVED. BREAKAGE PROBABLY DUE TO AGE OF EQUIPMENT.
THE RETAINING SCREWS BROKE ON TOP OF THE SHOULDERED ABUTMENTS. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-00012.
DEVICE WOULD NOT INFUSE. EXP DATES: 04/96/04-2001.
PT'S EPIDURAL INFUSION LINE MISSING INNER BLUE VALVE CAUSING A POTENTIAL FOR FREE FLOW PROBLEM.
IT HAS BEEN REPORT THAT AN ABUMENT SCREW HAS FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT UNJURY HAS NOT BEEN REPORTED.
IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW HAD FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE SCREW FRAGMENT COULD NOT BE REMOVED. CUSTOM DESIGN HAS FABRICATED A SPECIAL SCREW IN ORDER TO MAINTAIN FUNCTION OF THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
PT POST CABG SURGERY FROM 7/10/96 AND CONDITION DETERIORATED 7/12/96. PT HAD DECREASED BP, RESP DISTRESS, AND WAS PLACED ON IABP AT BEDSIDE AT APPROX 3 AM 7/12/96. LEAK NOTED IN IAB INTRA-AORTIC BALLOON AT APPROX 10:30 AM ON 7/12/96. THE BALLOON WAS REPLACED AT APPROX 6PM 7/12/96.
LAPAROSCOPIC CHOLECYSTECTOMY WAS PERFORMED. DURING THE CLOSURE OF THE UPPER MIDLINE SITE, THE SUTURE NEEDLE BROKE WITH THE VERY FIRST PASS. ATTEMPTS TO RECOVER THE DISTAL PORTION OF THE NEEDLE BY LAPAROSCOPIC MEANS WERE UNSUCCESSFUL. X-RAYS CONFIRMED 1.5 CM DISTAL PORTION OF THE NEEDLE, WHICH WAS LOCATED IN THE ANTERIOR ABDOMINAL WALL AND NOT IN THE PERITONEAL CAVITY. IT WAS DECIDED TO LEAVE THE NEEDLE, SINCE REMOVAL WOULD REQUIRE OPEN CONVERSION. THE PT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED THE FOLLOWING DAY. ANY COMPLICATIONS FROM NEEDLE ARE NOT EXPECTED, BUT UNKNOWN AT THIS TIME.
THE PT WAS FOUND UNRESPONSIVE IN RESPIRATORY ARREST. THE NURSES CLAIM THAT THE SPO2 PROBE HAD SLIPPED OFF HIS FINGER, BUT THE MONITOR WAS NOT ALARMING FOR SPO2 NONPULSATILE. THE NURSING STAFF HAD LAST CHECKED ON THE PT ABOUT TEN MINUTES BEFORE THE INCIDENT. THE PT HAD AN EXTERNAL PACING DEVICE. ARRHYTHMIA STRIPS FROM THE CENTRAL STATION WHICH WERE PRINTED FROM ALARM HISTORY INDICATE A THREE STAR BRADY ALARM. THE PT WAS RESUSCITATED AND TAKEN TO CARDIO-VASCULAR ICU WHERE HE DIED THREE DAYS LATER.
INFANT PRESENTED TO THE ED NONRESPONSIVE AND IN CARDIOPULMONARY ARREST. ACLS BEGUN AT TIME OF ARRIVAL. DURING THE CODE THE DEFIBRILLATOR WAS CHARGED TO 10 JOULES, BUT WOULD NOT FIRE (DISCHARGE) AFTER 2 ATTEMPTS. THE DEFIBRILLATOR WAS THEN CHARGED TO 20 JOULES AND DID FIRE AND WAS FIRED DURING THE CODE TWICE THEREAFTER. DEFIBRILLATOR WAS EXAMINED TWICE BY A BIOMEDICAL COMPANY. ON THE SECOND EXAM A SMALL PLASTIC OBJECT WAS FOUND IN THE DISCHARGE BUTTON THAT WAS BROKEN ON THE STERNUM PADDLE.
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION INVOLVING ONE PT. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP REPORTED NO PT INJURY.
10/25/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA BY MFG. ADDITIONAL INFORMATION SUBMITTED FOR D7, D8 AND D9. DEVICE EVALUATED INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA SUBMITTED FOR B4 AND F8.
DURING SURGERY FOR BLEBS, THE CLIP CAME OFF OF THE APPLIANCE AND FELL INTO THE PT'S THORACIC CAVITY. NO HARM TO PT.
IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW HAS FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURIGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. HE COULD NOT REMOVE THE FRAGMENT. THE IMPLANT HAD TO BE REMOVED FROM THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
THE DEVICE WOULD NOT ALLOW GAS TO GO INTO PT.
THE LENS WAS INSERTED INTO THE EYE AND WAS OBSERVED TO HAVE A PIECE MISSING FROM ONE OF THE HAPTICS. THE INCISION WAS ENLARGED TO REMOVE THE LENS. USER FACILITY STATES THAT NO PORTIONS OF THE LENS WERE LEFT IN THE PT'S EYE.
A4: PATIENT WEIGHT NOT PROVIDED BY USER FACILITY. D7: NA - DEVICE IS NOT AN IMPLANT. D8: NA - DEVICE IS NOT AN IMPLANT, THEREFORE IT CANNOT BE EXPLANTED. F9: INFORMATION UNK BECAUSE USER FACILITY WAS UNABLE TO PROVIDE LOT NUMBER OF THE DEVICE. F10: PATIENT CODE - (CORRECTED) 2200 (OTHER) INCISION ENLARGEMENT, UNLABELED. H3: EVALUATION RESULTS - RETURNED PRODUCT CONFIRMED THAT A PIECE OF THE LENS REMAINED STUCK IN THE INSERTION DEVICE. EVALUATION OF THE RETURNED LENS SHOWED THAT A CORNER OF THE HAPTIC WAS TORN AWAY.
THE DEVICE WAS REMOVED DUE TO "FAILURE". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 3-PIECE INFLATABLE.
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS REMOVED ON 8/6/96 BECAUSE IT "FAILED." NO IMPLANT INFORMATION WAS PROVIDED. REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADDITIONAL INFORMATION SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFORMATION HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFORMATION, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NOT MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
AREAS WHERE CANNULAS ENTER NARES AND FIT OVER EARS, THE PRODUCT CRUMBLES TO PIECES AFTER A FEW DAYS OF USE.
BASED ON THE EVAL OF THE USER FACILITY'S BIOMEDICAL COMPANY, THE REPORTED DEVICE MALFUNCTION OF INTERMITTENT FAILURE TO DISCHARGE IS BELIEVED TO BE CAUSED BY A BROKEN DISCHARGE BUTTON COVER. THE BROKEN DISCHARGE BUTTON COVER WAS REPLACED. THE DEVICE WAS SENT TO CO FOR EVAL AFTER FACILITY'S INITIAL EVAL AND REPAIR OF THE DEVICE . CO CONDUCTED VISUAL INSPECTION AND PERFORMANCE TESTING OF THE DEVICE WHICH REVEALED THAT THE BATTERY RETURNED WITH THE DEVICE WAS A NON CO APPROVED BATTERY WHICH DID NOT MEET SPECIFICATIONS. THE DAMAGED DISCHARGE BUTTON COVER HAS NOT BEEN RETURNED TO CO FOR INSPECTION TO DATE. THE OPERATOR'S MANUAL FOR THE DEVICE INSTRUCTS USERS TO INSPECT THE PADDLES AND THE DISCHARGE BUTTON COVERS FOR POSSIBLE DAMAGE BEFORE USE AS PART OF THE ROUTINE MAINTENANCE OF THE DEVICE.
WHEN CLIENT ACTIVATED SYSTEM, JUST PRIOR TO INFUSION, THEY NOTED "BLUE WATER" IN WITH MEDICATION. UPON INSPECTION RPTR NOTED BLUE IN THE VALVE RELEASE AND MEDICATION COMPARTMENT. MEDICATION WAS NOT USED BY THE CLIENT.
THE DEVICE WAS REVISED DUE TO "AUTOINFLATION". THE SURGEON REDUCED THE RESERVOIR FLUID VOLUME BY 16 CC'S AND REPLACED THE REAR TIP EXTENDER(S), AND CHANGED CONNECTOR(S). ADDITIONALLY, IT WAS STATED THAT THE "DEVICE COMPONENT(S) WERE DESTROYED."
BASED ON THE LIMITED INFO RECEIVED, QA CONCLUDES THIS PROCEDURE WAS PERFORMED TO ADJUST THE FLUID VOLUME OF THE DEVICE TO ADDRESS THE OCCURRENCE OF AUTOINFLATION. QA ALSO CONCLUDES THAT THE DECISIN TO LEAVE THE DEVICE IMPLANTED SUGGESTS DEVICE FUNCTION WAS NOT A CONTRIBUTING FACTOR TO THIS OCCURRENCE, AND THAT EVAL OF THE REMOVED CONNECTORS WOULD NOT PROVIDE INFO TOWARDS THIS EVAL. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAT WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
PUMP WENT UP TO 1400 ML/MIN RATE. THE PUMP WAS PULLED AND NO PT EVENT OCCURRED. CLINICAL ENGINEERING WAS UNABLE TO DUPLICATE THE EVENT.
THE BIOPROSTHESIS WAS REMOVED DUE TO MITRAL INSUFFICIENCY. THE SURGEON NOTED THAT THE PT HAD EXPERIENCED INCREASED DYSPNEA ON EXERTION, COUGH AND DECREASE IN ACTIVITY. THE VALVE HAVE BEEN IMPLANTED 126 MONTHS. PT AGE AT IMPLANT 69.
THE "PT CAME INTO DR'S OFFICE WITH WHAT HE THOUGHT TO BE A SORE ON PENIS. PHYSICIAN DETERMINED THAT THE INFLATABLE PENILE PROSTHESIS HAD ERODED THROUGH THE SKIN AND WAS INFECTED. PT WAS IMMEDIATELY SENT TO HOSPITAL, PREPPED FOR SURGERY, AND THE PROSTHESIS REMOVED. REMAINED IN HOSPITAL TWO DAY. POST-OP VISIT WITH PHYSICIAN OK".
EVAL AN DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUSAL FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION. ADD'L INFO: (SECTION H 3) ON 8/26/96, A HOSPITAL STAFF MEMBER CALLED OFFICE FROM THE CLINCAL ENGINEERING DEPT. AS STATED, IT IS THE POLICY OF THEIR RISK MGMT DEPT TO RETAIN ANY SPECIMENS FOR 90 DAYS, AFTER WHICH TIME THEY WILL BE SENT TO THE MFR. THEREFORE, THEY ANTICIPATE RELEASING THE DEVICE ON 10/24/96. AT THAT TIME, IF THE DEVICE IS RECEIVED, OFFICE WILL REOPEN THIS FILE TO TEST AND EXAMINE THE RETURNED DEVICE.
THE PT WAS IMPLANTED BILATERALLY WITH SALINE PROSTHESIS ON 11/2/95. ON 11/12/95 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED A SEROMA IN THE LEFT BREAST AND AN INFECTION IN THE RIGHT BREAST. BOTH PROSTHESES WERE REMOVED ON 12/27/95. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION". SEE PRODUCT EVAL ATTACHED HERETO. RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO FORM A MEDICAL OPINION AS TO THE RELEVANCYI OF THE PT'S HISTORY TO THE EVENT REPORTED. MENTOR H/S DEFERS TO THE PT'S PHYSICIAN AND TO ANY CHARACTERISTICS REFERENCED IN THE PRODUCT EVAL ATTACHED HERETO.
THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 3-PIECE INFLATABLE PENILE PROSTHESIS.
IN THE RECEIVED INFO, THE MD STATED THAT "NO DAMAGE (WAS) OBSERVED" WITH THE DEVICE. THE MFR RECEIVED AND EVALUATED THE ENTIRE DEVICE. DURING FUNCTIONAL TESTING, A LEAKAGE SITE WAS OBSERVED NEAR THE DISTAL CONNECTOR OF ONE OF THE CYLINDERS. A MICROSCOPIC EXAMINATION OF THE LEAKAGE SITE WAS PERFORMED. BOTH THE INNER LAYER AND OUTER LAYER OF TUBING WAS SWEPARATED. THE CROSS SECTIONAL SURFACES OF THE EFFECTED TUBING WERE ROUGH AND IRREGULAR, INDICATING THAT THE TUBING WAS TORN. NEAR THE LEAKAGE/SEPARATION/TEAR SITE, AN AREA OF TUBING ABRASION WAS DETECTED. BASED THE RECEIVED INFO AND QUALITY ASSURANCE'S EXAMINATION, QA CONCLUDES THAT THE LEAKAGE/SEPARATION/TEAR SITE CAUSED THE REPORTED MALFUNCTION. THE ABRADING OF THE TUBING NEAR THE CONNECTOR SITE SUPPLIED SUFFICIENT STRESS(ES) TO TEAR THE TUBING, AND THUS CAUSE A LEAK.
THE RECEIVER WAS REPORTEDLY EXPLANTED DUE TO PT TISSUE REACTION. DEVICE EXPLANTED 2 WEEKS AGO. IMPLANTED 1 YR AGO.
THIS EVENT IS REFERENCED BY CO REPORT #NC080196432. CO IS IN THE PROCESS OF GATHERING ADD'L INFO AND EVALUATING THE RETURNED PRODUCT.
THE DEVICE WAS REMOVED DUE TO "BROKEN TUBING AT THE SPRING". THE "SPRING HAD SPRUNG".
THE DEVICE WAS RETURNED TO AND EVALUATED BY THE MFR. THERE WERE MULTIPLE AREAS OF DAMAGE. ON THE SERIALIZED OUTLET TUBING, PROXIMAL FROM THE PUMP, AN AREA OF ABRASION EXISTED (AREA A). A SEPARATION SITE DISTAL FROM THE PUMP WAS NOTED (AREA B). THE NON-SERIALIZED OUTLET ALSO HAD AN AREA OF ABRASION PROXIMAL TO THE PUMP (AREA C), AND A SEPARATION/LEAKAGE SITE DISTAL FROM PUMP (AREA D). THE CONNECTOR WAS CRACKED, AND LEAKAGE WAS OBSERVED FROM THIS CONNECTOR (AREA E). THE INLET TUBING WAS ABRADED, HAD PROTRUDING MONOFILAMENT, AND REVEALED A SEPARATION/LEAK/TEAR SITE PROXIMAL TO THE PUMP (AREA F). PROXIMAL TO THE RESERVOIR, A TUBING SEPARATION/LEAK SITE WAS DETECTED (AREA G). MICROSCOPIC EXAMINATION OF THE ANOMALY SITES WAS PERFORMED. THE CROSS SECTIONAL SURFACES OF AREA B AND AREA D SHOW SMOOTH, NON-STRIATED SURFACES, INDICATING CONTACT WITH A CAUTERY INSTRUMENT. THE CROSS SECTIONAL SURFACE OF AREA G SHOWS UNIFORM STRIATIONS, INDICATING CONTACT WITH SHARP INSTRUMENTATION, SUCH AS SCISSORS OR SCALPEL. THE CROSS SECTIONAL SURFACES OF AREA F SHOWED ROUGHT, IRREGULAR SURFACES, INDICATING A TUBING TEAR. RECREATION OF THE TUBING, BASED ON THE PATTERN OF ABRASIONS , SHOWS THAT WHILE IN-VIVO THE PUMP TUBING WAS OVERLAPPING AND RUBBING AGAINST EACH OTHER. BASED ON THE RECEIVED INFO AND THE EXAMINATION, QA CONCLUDES THAT THE REPORTED FAILURE WAS A RESULT OF THE SEPARATION TEAR ON THE INLET TUBING (AREA F). FURTHER, THIS SEPARATION WAS CAUSED BY THE STRESS(ES). SINCE THE LEAK SITE IS CONTAINED WITHIN AN AREA OF ABRASION, QA CONCLUDES THAT THE MATERIAL IN THIS AREA WAS WORN AND FATIGUED. STRESS(ES) ASSOCIATED WITH DEVICE USAGE OVER TIME IN COMBINATION WITH THE MATERIAL FATIGUE CAUSED THE TUBING TEAR, RESULTING IN THE LEAKAGE SITE. BASED ON THE DURATION OF IMPLANT, INSTRUMENT DAMAGE WAS NOT THE CAUSE OF THE FAILURE. QA CONCLUDES THAT THE INSTRUMENT DAMAGE OCCURRED DURING OR SUBSEQUENT TO EXPLANT SURGERY.
THE BIOMEDICAL TECHNICIAN LOOKED AT THE ERROR CODES IN THE STATUS LOG AND WAS TRYING TO RETRIEVE TREND DATA WHEN THE MONITOR REBOOTED BY ITSELF. THIS CAUSED THE LOSS OF ERROR CODES AND THE TREND DATA. CO CE WENT TO THE SITE AND TESTED THE SYSTEM. THE ALARM VOLUME AT THE CENTRAL STATION WAS SET VERY SOFT AND COULD BARELY BE HEARD AT THE CENTRAL STATION UNLESS YOU PLACED YOUR HEAD RIGHT NEXT TO THE CENTRAL STATION. SINCE THE MONITOR REBOOTED BY ITSELF, THE CE REPLACED THE SYSTEM BOARD, RELOADED THE SOFTWARE AND RECONFIGURED THE MONITOR. THE SYSTEM APPEARS TO BE WORKING PROPERLY.
THE DEVICE WAS REMOVED DUE TO AN "INFECTION". THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED.
EVAL IS PENDING DECONTAMINATION, EXAMINATION AND TESTING OF THE RETURNED DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION.
A PT WAS TREATED ON 6/27/96 IN THE VERMILION BORDERS. ON THE APPROX 7/9/96, SHE DEVELOPED DIARRHEA, VOMITING, FEVER, AND DEHYDRATION WHILE DIAGNOSED WITH A GASTROINTESTINAL INFECTION, KIDNEY FAILURE, AND DECREASED PLATELETS. INTRAVENOUS MEDICATION WAS PRESCRIBED: TYPE UNKNOWN. THE TREATMENT SITES REMAINED ASYMPTOMATIC. THE PT BELIEVED THAT THE SYMTPONS WERE POSSIBLY RELATED TO COLLAGEN. SHE DID NOT CONSULT THE INJECTING PHYSICIAN REGARDING THE ALLEGED SYMPTOMS.
ON 9/19/96, CLINICAL REPORT FORMS WERE RECEIVED FROM THE INJECTING PHYSICIAN WITH THE FOLLOWING COMMENT: "IN TALKING WITH THIS PATIENT, IT DOES NOT SEEM THAT THIS WAS IN ANY WAY COLLAGEN RELATED."
RUBBER DAM CLAMP WAS PLACED AND BROKE IN THE PT'S MOUTH. IT COULD HAVE BEEN SWALLOWED CAUSING ASPIRATION OF THE CLAMP, BUT LUCKILY IT WAS NOT.
THE DEVICE WAS REMOVED DUE TO "EROSION OF A CYLINDER INTO THE URETHRA".
TO DATE THE DEVICE HAS NOT BEEN RETURNED FOR EVAL AND NO ADD'L INFO HAS BEEN RECEIVED, HOWEVER, BECAUSE EVAL OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR DISAPROVE THE REPORT OF EROSION, QA WILL ACCEPT THE PHYSICIAN'S OBSERVATIONS OF THIS AS THE CAUSE FOR REMOVAL. BASED ON THE LIMITED INFO RECEIVED, QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THIS EVENT. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
PT WAS TREATED ON 8/26/96 DISCOLORATION AND PAIN WERE NOTED AT THE GLABELLAR TREATMENT SITE. ON 8/28/96, SYMPTOMS PERSISTED. ON 8/29/96, THE PT NOTED REDNESS AND SWELLING WHICH EXTENDED FROM THE GLABELLAR TREATMENT SITE TOWARD THE BRIDGE OF THE NOSE. THE PHYSICIAN DIAGNOSED A VASOSPASM; INTRAMUSCULAR CORTISONE AND ORAL PREDNISONE WERE PRESCRIBED. AS OF 9/3/96, ALL SYMPTOMS HAD IMPROVED.
THE BIOPROSTHESIS WAS REMOVED DUE TO MITRAL INSUFFICIENCY. THE SURGEON NOTED THAT THE PT HAD EXPERIENCED INCREASED DYSPNEA ON EXERTION, COUGH AND DECREASE IN ACTIVITY. THE VALVE HAD BEEN IMPLANTED 126 MONTHS. PT AGE AT IMPLANT 69.
SUBMISSION OF INFO BY CO UNDER THE MDR REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." THIS EVENT WAS FIRST REPORTED TO CO BY THE MD. MEDTRONIC SENT MEDWATCH FORM TO THE USER FACILITY TO COMPLETE PER CO REQUEST. H11, H10, CODES: PT CODE# 1818, NOT LABELED, #1963, LABELED. DEVICE CODES: #1153, NOT LABELED. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A." H.3 ANALYSIS: PRODUCT ANALYSIS SHOWS THAT THE MITRAL INSUFFICIENCY WAS THE RESULT OF WEAR AND TISSUE DEGENERATION THAT IS ASSOCIATED WITH MINERALIZATION. H.6 CONCLUSION CODE 68: DEVICE PERFORMED AS EXPECTED AND WAS RELATED TO THE REPORTED EVENT.
THE DEVICE WAS REMOVED DUE TO A "TUBING BREAK". THE RESERVOIR AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED. ADDITIONALLY, IT WAS STATED THAT "PT EXPERIENCED TRAUMA RESULTING FROM A PELVIC FRACTURE". THE PHYSICIAN STATED THAT "THIS MAY OR MAY NOT HAVE CONTRIBUTED TO OR CAUSED THIS EVENT".
EVAL AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE COMPONENT(S). FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION.
CATHETER WAS USED FOR CHEMOTHERAPY TREATMENT. AFTER COMPLETION OF THE CHEMO TREATMENTS, THE CATHETER WAS ALLOWED TO REMAIN IN PLACE FOR ROUTINE BLOOD DRAWS. DURING THE LAST VISIT THE PT EXPERIENCED PAIN AND FELT A "POP" DURING THE FLUSHING PROCEDURE, AFTER WHICH NO BLOOD COULD BE DRAWN FROM THE CATHETER. THE PT WAS TAKEN TO OR FOR REMOVAL OF CATHETER. THE PHYSICIAN GENTLY REMOVED THE CATHETER WITHOUT RESISTANCE. HOWEVER, THE PHYSICIAN IMMEDIATELY NOTED THAT THE DISTAL PORTION OF THE CATHETER WAS MISSING. X-RAY REVEALED THE DISTAL PORTION REMAINED IN THE RIGHT ATRIUM.
PT WAS SKIN TESTED ON 5/10/96. IMMEDIATELY AFTER THE SKIN TEST, REDNESS WAS NOTED AT THE SKIN TEST SITE, WHICH RESOLVED SPONTANEOUSLY ON APPROX 5/11/96. ON 5/19/96, THE PT NOTED A 1 CM AREA OF REDNESS AT THE SKIN TEST SITE WHICH RESOLVED SPONTANEOUSLY ON APPROX 5/23/96. ON 7/27/96, ITCHING RECORDED. THE PT PRESENTED WITH ERYTHEMA, SWELLING, AND PRURITUS AT THE SKIN TEST SITE. THE PHYSICIAN DIAGNOSED A POSITIVE SKIN TEST; INTRALESIONAL ARISTOCORT WAS PRESCRIBED. AS OF 9/3/96, THE SYMPTOMS WERE RESOLVED (EXACT DATE OF RESOLUTION UNKNOWN).
ORIGINAL IMPLANT OCCURRED ON 4/28/78. PT PRESENTED WITH UGH (UVEITUS,GLAUCOMA,HYPHEMA). LENS WAS REMOVED ON 7/1/96. PT WAS TREATED WITH TOPICAL CORTICOSTEROIDS AND ANTIBIOTICS; PT PROGNOSIS IS GOOD.
THE CATHETER FRAGMENT IN THE PT'S RIGHT ATRIUM WAS SNARED OUT.
DEVICE WAS USED DURING A TOTAL GASTRECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE STAPLES DID NOT FORM COMPLETELY DURING APPLICATION. THE ORIGINAL APPLICATION SITE WAS RESECTED AND A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.
EVALUATION OF THIS DEVICE REVEALED MICROSCOPIC EVIDENCE ON THE SURFACE OF THE CARTRIDGE INDICATING STAPLES DID NOT FORM PROPERLY AS REPORTED BY THE USER. ALSO, OBASERVED WAS MICROSCOPIC EVIDENCE AND DAMAGE TO THE CARTRIDGE WHICH INDICATES THE USER FAILED TO PROPERLY SEAT THE ALIGNMENT PIN PRIOR TO FIRING. AS A RESULT, THE STAPLES DID NOT CONTACT THE ANVIL PROPERLY AND MALFORMED STAPLES OCCURRED. THE STAPLER WAS RELOADED AND TEST FIRED WITH SATISFACTORY RESULTS. THE INSTRUMENT PERFORMED IN ACCORDANCE WITH SPECIFICATIONS WHEN TESTED AT OUR FACILITY. THE INSTRUMENT INFORMATION BOOKLET WHICH ACCOMPANIES EACH DEVICE SHIPMENT ADVISES THE USER ON SEATING THE ALIGNMENT PIN PRIOR TO FIRING.
PT WAS ADMITTED TO THE HOSP WITH ABDOMINAL PAIN. HEMOLYSIS WAS IDENTIFIED AT THE HOSP. THE PT'S LDH 1057, HCT. 31.9. PREVIOUS HCT. 34.7 ON 7/30/96. THE PT DIALYZED ON 8/6/96 DURING THE AFTERNOON AND WAS ADMITTED TO THE HOSP ON 8/7/96 IN THE MORNING. THE SAMPLE WAS DISCARDED BY THE FACILITY. IT WAS NOTED BY THE CLINIC THAT THERE WERE NO UNUSUAL EVENTS DURING THE PT'S TREATMENT.
DEVICE WAS USED DURING AN ESOPHAGOGASTRECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, AN ANASTOMOTIC LEAK WAS NOTED FOUR DAYS POST-OPERATIVELY., THE PT WAS TREATED FOR MEDIASTINITIS WITHOUT INCIDENT.
THE INITIAL REPORTER, THE SURGEON, SUBMITTED THIS INFO TO THE MFR. THE USER FACILITY HAS NOT REPORTED THIS EVENT.
PT WAS TO RECEIVE TAXOL FOR X 96 HRS. THE IV BAGS AND TUBING SETS WERE CHANGED DAILY. DAY 1 - 490 ML WAS DELIVERED BY THE PUMP. DAY 2 - 440 ML WAS DELIVERED EVEN THOUGH THE PUMP SHOWED TO HAVE DELIVERED 490 ML. DOSE WAS SHORT 50 ML. DAY 3 - 420 ML OF THE 490 ML DOSE WAS DELIVERED. SHORT 70 ML. DAY 4 - 405 ML OF THE 490 ML DOSE WAS DELIVERED. SHORT 85 ML. THE IV BAGS WERE CHANGED ON TIME EACH DAY AND EACH DAY THE VOLUME DELIVERED SHOWED 490 ML. THE PUMP DID NOT INFUSE THE TOTAL DOSE TO THE PT.
DEVICE WAS USED DURING A LEFT COLECTOMY PROCEDURE. THE ANASTOMOSIS WAS INTACT WHEN INSPECTED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. REPORTEDLY, THE PT RETURNED TO SURGERY TEN DAYS POST-OPERATIVELY DISPLAYING AN ANASTOMOTIC LEAK.
PT WAS TREATED ON 8/29/96 IN THE UPPER AND LOWER VERMILION BORDERS, ORAL COMMISSURES AND NASOLABIAL FOLDS. THE PT EXPERIENCED SLIGHT SWELLING AND BLEEDING AT ALL INJECTION SITES DURING THE TREATMENT WHICH WAS ATTRIBUTED TO THE INJECTION PROCEDURE. THE SYMPTOMS RESOLVED BY THE TIME THE PT LEFT THE OFFICE. LATER IN THE DAY, THE PT DEVELOPED SWELLING OF THE UPPER LIP AND IRREGULAR HEART BEATS. THAT EVENING, THE PT ALLEGED THAT THE UPPER LIP SWELLED TO SIX TIMES ITS NORMAL SIZE. AN EMERGENCY ROOM PHYSICIAN DIAGNOSED THE LIP SWELLING AS ANGIOEDEMA, POSSIBLY RELATED TO THE COLLAGEN, AND HE ATTRIBUTED THE IRREGULAR HEART RHYTHM TO ALTACE. PREDNISONE, ZANTAC, AND ATARAX WERE PRESCRIBED, AND THE PT WAS ADVISED TO DISCONTINUE THE ALTACE. THE IRREGULAR HEART BEAT RESOLVED ON 8/29/96 AND THE ANGIOEDEMA RESOLVED BY 9/1/96. THE PT ALLEGED NO CORRECTION WAS NOTED AT THE UPPER VERMILION BORDER TREATMENT SITE AFTER RESOLUTION OF THE SWELLING.
PAT. PROB. CODE: 2442-LABELED. PAT. PROB. CODE: 2469-NOT LABELED. PAT. PROB. CODE: 1701- NOT LABELED. PAT. PROB. CODE: 1701-NOT LABELED. DEV. 1 PROB CODE: 1043-LABELED. EXPIRATION DATES (CONTINUED) #1 ZYPLAST COLLAGEN IMPLANT: 12/31/98. DEVICE MFR DATES(CONTINUED) 1/96.
FACILITY REPORTED THAT 15 MINUTES INTO HEMODIALYSIS TREATMENT, THE PT COMPLAINED OF SEVERE BACK PAIN AND SOB. THE PT WAS GIVEN 25MG IV BENADRYL AND O2 AT 2L/MIN. THE MD WAS NOTIFIED OF THE PT'S CONDITION. BP177/78, PULSE 112. THE PT'S BLOOD WAS RINSED BACK AND THE PT WAS PUT ON A DIFFEREWNT DIALYZER AND TREATMENT WAS RESUMED WITHOUT FURTHER INCIDENT. THE SAMPLE WAS DISCARDED BY THE UNIT.
PT COMPLAINED OF LEFT SIDED CHEST PAIN, STATUS POST LEFT (TITANIUM) PLACED 4/96. A PORTION OF THIS CATHETER DISLODGED, REQUIRING SURGICAL REMOVAL.
HOME CARE PT RECEIVING TPN. PROGRAM: RES VOL 1060; INFUSION VOLUME 960. WHEN THE PT WENT TO DISCONTINUE THE INFUSION THE RES VOL WAS 980 MLS AND THE BAG WAS FULL. PT DID NOT COMPLETE DUAL RESET. LABEL WAS ON PUMP FOR REMINDER OF THIS STEP.
CATHETER WOULD NOT CALIBRATE, IT WAS NEVER USED ON PT.
FACILITY REPORTED THAT 15 MINUTES INTO HEMODIALYSIS TREATMENT, THE PT COMPLAINED OF SOB AND SEVERE LOWER BACK PAIN. THE PT WAS GIVEN BENADRYL AND O2 WITHOUT RELIEF. THE PT'S BLOOD WAS REINFUSED AND THE SYMPTOMS SUBSIDED. THE PT WAS DISCHARGED FROM THE UNIT AFTER WAITING 1 HOUR AND NO DISCOMFORT WAS NOTED. THE SAMPLE WAS DISCARDED BY THE FACILITY.
THE REPORTER INDICATED THAT THE CATHETER HAD BROKEN OFF FROM THE PORT BUT HAD NOT EMBOLIZED. THE REPORTER DESCRIBED THE PORT AS HAVING A PIECE OF ATTACHED CATHETER ON THE PORT STEM.
REPORT REC'D BY CO SALES REP. SHE WAS INFORMED AS FOLLOWS: APPROX 3 WEEKS AGO, DURING A CODE SITUATION, A BAG OF DOBUTAMINE WAS MIXED. THE BAG WAS SPIKED AND PRIMED. LATER, USERS REALIZED THAT THERE WAS NO LATEX PORT ON THE LOWEST Y-SITE. THE SOLUTION CAME OUT OF THE PORT ONTO THE BED AND WAS NOT DELIVERED TO THE PT. ANOTHER BAG AND SET WERE PREPARED. THE CUSTOMER WAS CONCERNED THAT THIS SITUATION CAUSED A DELAY IN TREATMENT, BUT STATED THAT THEY DID NOT FEEL THE DELAY CONTRIBUTED TO THE DEATH OF THE PT. THE ACCOUNT WAS "NOT COMFORTABLE GIVING OUT ANY FURTHER INFO RELATED TO THIS ISSUE".
THE ADMINISTRATION SET WAS NOT RETURNED FOR TESTING AND ANALYSIS. THE LOT NUMBER WAS NOT AVAILABLE, THUS MFR DATE COULD NOT BE DETERMINED. COMPLETE INFO WAS NOT AVAILABLE FROM HOSP SOURCES.
CO REP WENT TO THE CUSTUMER'S SITE TO CHECK THE EQUIPMENT. THE TELEMETRY TRANSMITTER WAS GIVING CONSTANT "BATT/RANGE INOP WAVE INVALID" AT THE CENTRAL STATION. THE TRANSMITTER WAS MODERATELY DIRTY, SOME FOREIGN MATERIAL WAS IN THE BATTERY AND LEAD WIRE CAVITIES, AND IT SEEMED TO BE FUNCTIONALLY AND MECHANICALLY SOUND. ALL CONNECTIONS, INDICATOR LAMPS AND SWITCHES CHECKED OUT ON THE TELEMETRY RECIEVER. HE FOUND THE ARRHYTHMIA SYSTEM, CENTRAL STATION, AND RECORDER FUNCTIONING PROPERLY. THE TELEMETRY UNIT HAS BEEN TAKEN OUT OF SERVICE. THE TELEMETRY RECORDING STRIPS SHOWED THAT THE ALARMS HAD BEEN TURNED OFF AT THE CENTRAL STATION. THE CUSTOMER HAS BEEN NOTIFIED.
EVENT BROUGHT TO THE ATTENTION OF RISK MANAGEMENT TWO MONTHS POST SURGERY. THEREFORE, REPORT IS LATE. ACCORDING TO SURGEON, PORT DEFECTIVE AND HAD TO BE REPLACED.
AN IMPLANT HAS FRACTURED. PT INJURY HAS NOT BEEN REPORTED.
TROUBLE GIVING PT MEDS THRU PORT, PT TAKEN TO FLUORO TO HAVE PORT REMOVED. CATHETER WAS SPLIT INTO 2 PIECES.
TROUBLE GIVING PT MEDS THRU PORT, PT TAKEN TO FLURO TO HAVE PORT REMOVED. CATHETER WAS SPLIT INTO 2 PIECES.
BASELINE REPORT FOR THIS DEVICE FAMILY SUBMITTED WITH 2183502-1996-00001, DATED 8/27/96.
DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE ANASTOMOSIS WAS INTACT WHEN INSPECTED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. REPORTEDLY, THE PT RETURNED TO SURGERY ELEVEN DAYS POST-OPERATIVELY DISPLAYING AN ABCESS ATTRIBUTED TO AN ANASTOMOTIC LEAK. THE ABCESS WAS DRAINED WITHOUT INCIDENT.
DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE ANASTOMOSIS WAS INTACT WHEN INSPECTED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. REPORTEDLY, THE PT WAS RE-ADMITTED TEN DAYS POST-OPERATIVELY DISPLAYING PERITONITIS. THE PT EXPIRED ONE DAY AFTER RE-ADMITTANCE DUE TO MULTIPLE SYSTEMS ORGAN FAILURE.
AN ABUTMENT SCREW HAS FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
BIOMECHANICAL OVERLOAD OF COMPONENT CAUSED BY COMPONENT BEING SUBJECTED TO HIGH BENDING MOMENTS.
THIS SUPPLEMENTAL REPORT REPRESENTS A CORRECTION FOR CLERICAL ERROR IN SECTION D, D.7. ON THE INITIAL REPORT THE DATE OF 4/5/96 WAS TYPED IN ERROR IN THIS SECTION AS THE IMPLANT DATE. THIS WAS ACTUALLY THE DATE EXPLANTED. THIS ERROR IS NOW CORRECTED AND IS NOW EXPRESSED IN THIS REPORT.
AN ABUTMENT SCREW HAD FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM INSIDE THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. NO PT INJURY HAS BEEN REPORTED.
PROSTHETIC RECONSTRUCTION LEAD TO BIOMECHANICAL OVERLOAD OF COMPONENT. PROSTHESIS IS BEING REMADE TO PREVENT RECURRENCE.
AN ABUTMENT SCREW HAD FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM INSIDE THE IMPLANT. THE IMPLANT IS STILL INSIDE THE PT'S MOUTH. NO PT INJURY HAS BEEN REPORTED.
PROSTHETIC RECONSTRUCTION LEAD TO BIOMECHANICAL OVERLOAD OF COMPONENT. PROSTHETIC IS BEING REMADE TO PREVENT RECURRENCE.
THE SURGEON WAS USING A FIXTURE MOUNT TO PLACE AN IMPLANT. THE SURGEON ATTEMPTED TO REMOVE THE FIXTURE MOUNT FROM THE IMPLANT AND THE FIXTURE MOUNT WAS STUCK TO THE IMPLANT. DURING SAME SURGERY THE IMPLANT WAS REMOVED BY THE DOCTOR. PT INJURY WAS NOT REPORTED.
MALFUNCTION OF FIXTURE MOUNT DIRECTLY LEAD TO REMOVAL OF IMPLANT.
AN ABUTMENT SCREW FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
THE SURGEON WAS USING A FIXTURE MOUNT TO PLACE AN IMPLANT. THE SURGEON ATTEMPTED TO REMOVE THE FIXTURE MOUNT FROM THE IMPLANT AND THE FIXTURE MOUNT WAS STUCK TO THE IMPLANT. DURING THE SAME SURGERY THE DOCTOR THEN REMOVED THE IMPLANT. PT INJURY WAS NOT REPORTED BY THE SURGEON.
MALFUNCTION OF FIXTURE MOUNT DIRECTLY CAUSED REMOVAL OF IMPLANT.
THE SURGOEN WAS USING A FIXTURE MOUNT TO PLACE AN IMPLANT. THE SURGEON ATTEMPTED TO REMOVE THE FIXTURE MOUNT FROM THE IMPLANT AND THE FIXTURE MOUNT WAS STUCK TO THE IMPLANT. DURING SAME SURGERY THE IMPLANT WAS REMOVED BY THE DOCTOR. PT INJURY WAS NOT REPORTED.
DEVICE WAS USED DURING A THORACOSCOPIC PROCEDURE. THE DEVICE CUT BUT DID NOT STAPLE PROPERLY WHEN APPLIED. THE PROCEDURE WAS CONVERTED TO A FORMAL THORACOTOMY AND THE BLEEDING WAS CONTROLLED WITH SUTURES. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE HOSP HAS REPORTED PT STATUS AS SATISFACTORY.
DEVICE DISPLAYED EVIDENCE THAT STAPLES HAD FIRED BUT DID NOT FORM COMPLETELY. DEFORMATION ON TEH CARTRIDGE INDICATES THAT THIS CONDITION WAS THE RESULT OF APPLYING TEH PRODUCT ACROSS AN OBSTRUCTION AND/OR EXCESSIVELY THICK TISSUE.
DEVICE WAS USED DURING A THORACOSCOPIC BULLECTOMY PROCEDURE. STAPLES DID NOT FORM PROPERLY. THE ORIGINAL APPLICATION SITE WAS RESECTED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE HOSP HAS REPORTED PT STATUS AS SATISFACTORY.
10/4/96-SUPPLEMENTAL REPORT SUBMITTED. EVALUATION INDICATED AND CODES ENTERED IN H-3 AND H-6.
INFUSION PUMP WAS SET AT 175CC PER HR. MACHINE OPERATED ALL NIGHT WITHOUT ANY ALARMS, BUT VOLUME DELIVERED WAS NOT CORRECT AT END OF SHIFT. NO APPARENT INJURY.
THE PT FELL TWO TIMES POST-OP. REVISION SURGERY REVEALED LOOSENING OF THE ACETABULAR CUP. THE FEMORAL HEAD AND ACETABULAR LINER WERE ALSO REPLACED AT THIS TIME.
SUMMARY OF EVALUATION: THIS FILE HAS BEEN REOPENED BECAUSE THE DEVICES WERE RETURNED TO THE MFG FACILITY FOR AN EVALUATION. EVALUATION RESULTS SUGGEST THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE BUT WOULD RATHER BE PT RELATED.
VENTILATOR "SHUT-DOWN". PT IMMEDIATELY REMOVED FROM VENTILATOR, BAGGED WITH O2 WHILE NEW VENTILATOR WAS SET UP. NO APPARENT INJURY.
TEN YEARS POST OP THE PT EXPERIENCED INCREASING PAIN. REVISION SURGERY REVEALED AN OSTEOLYTIC CYST APPROX 4-5CM IN DIAMETER WITHIN THE ACETABULUM. AS A RESULT OF THE OSTEOLYSIS, THE ACETABULAR CUP WAS REVISED. THE FEMORAL HEAD WAS ALSO REMOVED AT THIS TIME.
REQUESTS TO OBTAIN THE DEVICE WERE MADE TO THE USER FACILITY. THE DEVICE HAS NOT BEEN RETURNED TO CO; THEREFORE EVAL OF THIS EVENT CANNOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR THE ACETABULAR COMPONENT AND FEMORAL HEAD COMPONENT, WHICH IS INCIDENTAL TO THE EVENT, WERE REVIEWED AND NO DISCREPANCIES WERE OBSERVED. THE INFO PROVIDED SUGGESTS THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE BUT RATHER PT RELATED. THE RADIOGRAPHIC EVIDENCE OF THE OSTEOLYTIC CYST IN THE SUPERIOR LATERAL PORTION OF THE PT'S ACETABULUM WAS MOST LIKELY THE CONTRIBUTING FACTOR FOR THE REVISION OF THE ACETABULAR COMPONENT.
WHEN PROGRAMMING THE PUMP FOR A CONTINUOUS INFUSION, THE PUMP WAS SET IN MG/HR INSTEAD OF ML/HR. THE SCREEN IS DIFFICULT TO VIEW RELATED TO THE SIZE OF THE NUMERICS AND GLARE ON THE SCREEN.
DUAL CHAMBER TPN BAG LEAKED AT SEAM. TPN NOT USED.
ON 8/1/96 THE ACOUNT OBTAINED ERRATIC RESULTS ON ONE PT SAMPLE FOR PHENYTOIN. THE SAMPLE WAS RUN IN A PRIMARY TUBE FOR A RESULT=0.3 WHICH WAS REPORTED TO THE MD. THE MD QUESTIONED THE RESULT BECAUSE THE PT WAS ON IV DILANTIN. THE SAMPLE WAS REPEAT TESTED IN A SAMPLE CUP FOR A RESULT=20 WHICH WAS THEN REPORTED.
INVESTIGATION SUMMARY: THE EVENT REP. IS NOT ADDRESSED IN THE DEVICE LABELING. A MALFUNCTION DID OCCUR. THIS REPORTABLE MDR EVENT WAS INVESTIGATED AS PART OF AN ONGOING STUDY OF THE AXSYM SYSTEM BY CO INTO THE CAUSATIVE REASON FOR MALFUNCTIONS. RESULTS OF THE INVESTIGATION YIELDED A NUMBER OF SYSTEM ENHANCEMENTS IMPLEMENTED ON CUSTOMER UNITS. IMPROVEMENTS INCLUDED AXSYM SYSTEM SOFTWARE VERSION 3.0 WITH ENHANCED ALGORITHM FOR FLUID DETECTION, NEW BUFFER TUBING AND SEAL FITTINGS WHICH REDUCED BUBBLES FORMING IN TUBING LINES, MODIFICATIONS TO THE LIQUID LEVEL SENSE BOARD TO DECREASE SENSITIVITY OF THE INSTRUMENT TO ELECTROSTATIC DISCHARGE, AND PACKAGING MODIFICATIONS FOR ADDED PROTECTION TO PROBES. IN ADDITION, CO IS EMPHASIZED TO OUR CUSTOMERS THAT CORRECT OPERATING PROCEDURES MUST BE FOLLOWED TO ENSURE OPTIMAL PERFORMANCE OF THE AXSYM SYSTEM. AREAS THAT WERE EMPHASIZED INCLUDED PROBE CRASH RECOVERY PROCEDURE, RECOMMENDED TUBE SIZES AND TYPES, OPENING REAGENT BOTTLE 4, PROPER LOADING/UNLOADING OF REAGENT PACKS, AND ENSURING PROPER SAMPLE AND REAGENT HANDLING. THIS IS THE FINAL REPORT.
DURING A DIALYSIS TREATMENT, AIR PASSED THE UABD (ULTRASONIC AIR BUBBLE DETECTOR) WITHOUT AN ALARM. AIR WAS VISUALLY NOTED AT THE PT FISTULA. THE STAFF HAD TO INTERVENE TO PREVENT INJURY.
THE MEDICAL EQUIPMENT SERVICE REP (MES) FOUND THAT THE MACHINE DID NOT DETECT A 7 MICROLITER AIR BUBBLE, BUT DID DETECT AN 8 AND 10 MICROLITER BUBBLE. THE MES REPLACED THE UABD ASSEMBLY AND FUNCTIONALLY TESTED AS APPLICABLE. THE RETURNED UABD ASSEMBLY WAS VISUALLY INSPECTED AND CONFIRMED THAT THE ASSEMBLY WAS DESTROYED WHILE IT WAS REMOVED FROM THE MACHINE. THUS, THE ASSEMBLY COULD NOT BE TESTED TO CONFIRM THE REPORTED FAILURE AND A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. THE MES WAS NOTIFIED TO USE CAUTION WHEN REMOVING PARTS FROM MACHINES THAT ARE TO BE RETURNED FOR INVESTIGATION. HOWEVER, THE TEST BY THE MES TECH DID SHOW THAT THE DETECTOR DETECTED AN AIR BUBBLE SMALLER THAN 10 MICROLITERS, WHICH IS THE SPECIFICATION. THE RETURNED UABD ASSEMBLY WAS DESTROYED UPON REMOVAL FROM THE MACHINE. THEREFORE, AN INVESTIGATION WAS NOT POSSIBLE AND A DETERMINATION TO ITS FAILURE MODE COULD NOT BE DETERMINED. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR # 950033. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? Y. TRAINING REQUIRED? N.
ON 8/7/96 THERE WAS REMOVAL OF SUBCUTANEOUS VENOUS RESERVOIR. CENTRAL VENOUS CATHETER WAS LEFT IN SUBCLAVIAN SITE. UPON REMOVAL, IRRIGATION THROUGH THE RESERVOIR DEMONSTRATED A SPLIT IN THE CATHETER 8.5CM DISTAL TO ITS JUNCTION WITH THE RESERVOIR, THIS WAS A LINEAR SPLIT OF APPROX 6-8MM IN LENGTH. PT DID RECEIVE ADRIAMYCIN THROUGH THE CATHETER THAT INFILTRATED. CAUSED A READMISSION TO THE HOSP.
THE GUIDEWIRE BECAME LODGED IN PLAQUE DURNG A PTCA OF AN RCA. FOLLOW UP REVEALED DIFFICULTY WAS ENCOUNTERED DURING ADVANCEMENT OF THE WIRE. THE WIRE WAS MANIPULATED AND TWISTED IN AN EFFORT TO CROSS THE LESION. IT WAS INDICATED EXERTION WAS USED TO REMOVE THE WIRE AFTER ATEMPTS TO CROSS THE LESION FAILED. THE WIRE FRACTURED AND THE DISTAL TIP REMAINED IN THE PT. SURGICAL RETRIEVAL OF THE DETACHED TIP WAS ATTEMPTED, HOWEVER, COMPLETE RETRIEVAL COULD NOT BE ACCOMPLISHED. A PORTION OF THE DISTAL TIP REMAINS EMBEDDED IN THE PT'S PLAQUE, THE PT'S CONDITION WAS GOOD AND A DECISION WAS MADE TO LEAVE THE PORTION OF THE TIP IN THE PT. NO FURTHER ATTEMPTS AT RETRIEVAL WILL BE MADE. THE PROX PORTION OF THIS WIRE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE DISTAL END OF THE WIRE WAS UNRAVELLED AND THE DISTAL COILS WERE EXPOSSED. SINCE CO'S FOLLOW-UP REVEALED THIS WIRE WAS MANIPULATED AFTER RESISTANCE WAS ENCOUNTERED AND THAT AN EXERTED EFFORT UPON WITHDRAWAL WAS UTILIZED CO DOES NOT ATTRIBUTE THIS EVENT TO THIS DEVICE.
AT THE START UP OF A DIALYSIS TREATMENT, THE FACILITY REPORTED RESTRICTED BLOOD FLOW AND DRIP CHAMBERS FILLING. THE PT WAS TAKEN OFF THE MACHINE AND TREATMENT WAS COMPLETED ON ANOTHER MACHINE WITHOUT FURTHER INCIDENT.
THE MEDICAL EQUIPMENT SERVICE REP. (MES) FOUND A BROKEN BLOOD PUMP ROTOR SPRING AND REPLACED IT WITH A NEW ROTOR. THERE WERE NO PT INJURIES OR INTERVENTIONS REPORTED. THE RETURNED ROTOR WAS VISUALLY INSPECTED AND IT WAS CONFIRMED THAT ONE SPRING WAS BROKEN INTO 3 PIECES. THE RESTRICTED BLOOD FLOW AND DRIP CHAMBER FILLING DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING ALTHOUGH THE PART WAS NOT RETURNED. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO HEATHCARE CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR # 960018. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? Y. TRAINING REQUIRED? N.
PT UNDERWENT PARATIODECTOMY. NEUROSURGEON MONITORING DEVICE. DEVICE WAS PLACED ON PT. SURGEONS WERE CONCERNED THAT DEVICE WAS NOT WORKING WELL. DISCONTINUED USE OF MACHINE AND WENT TO A DISPOSABLE NERVE STIMULATOR. MONITOR WAS REMOVED FROM SERVICE AND EVALUATED BY BIOMED DEPARTMENT. BIOMED REPORTED THAT ONE OF THE CHANNELS IN THE CABLE WAS INCONSISTENT AND IF LEAD HAD BEEN BAD THE MONITORING COULD BE INACCURATE. HOWEVER, LEADS WERE FUNCTIONING PROPERLY. MONITOR SENT TO ECRI FOR INDEPENDENT REVIEW. PT DID EXPERIENCE A FACIAL PARALYSIS AS A RESULT OF THIS SURGERY BECAUSE OF THE SUPERIOR BRANCH OF FACIAL NERVE WAS CUT. THIS MACHINE IS USED AS AN AIDE IN SURGERY. 20% SURGEON'S KNOWLEDGE OF ANATOMY.
AFTER APPROX 1 HR 25MIN OF INSET TREATMENT, PT WAS FOUND UNRESPONSIVE AND CYANOTIC WITH BLOOD NOTED ON THE FLOOR. AFTER FURTHER EVALUATION, IT COULD NOT BE DETERMINED IF THE LUER-LOCK CONNECTION ON THE VENOUS BLOODLINE WAS PROPERLY SECURED TO THE VENOUS LIMB OF THE CATHETER. PT HAS A RT INTRAJUGULAR CATHETER ACCESS. -PT WAS INTUBATED AND TRANSPORTED TO THE HOSP WITH CPR IN PROGRESS. THE CATHETER CONTINUED TO BE USED AT THE HOSP WITHOUT PROBLEMS.
EVAUATION RESULTS: NO INDICATION OF THE DEFECT SHOWED DURING A REVIEW OF THE DEVICE HISTORY RECORD. -CONCLUSION: #72: PRODUCT OF THE SAME LOT NUMBER WAS EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CO RECOMMENDS: TO CAREFULLY EXAMINE THE PT END CONNECTOR AND THE LUER LOCK CONNECTOR FOR PROPER AND SAFE FITTING; TO FREQUENTLY MONITOR THE PT AND THE MECHANICAL DEVICES DURING TREATMENT WHICH WILL PREVENT THIS TYPE OF INCIDENT FROM REOCCURRING.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO PROVIDED BY CO. REPORT RECEIVED FROM THE FIELD INDICATED THAT, THE BALLOON BURST AT 18 ATMOSPHERES. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAM: THE CATHETER EXHIBITED A FULL LENGTH, CIRCUMFERENTIALLY-DIRECTED TEAR, 1.0 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAM: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) ON BOTH THE PROXIMAL AND DISTAL TEAR SEGMENTS OF THE BALLOON REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING THE TEAR SEGMENT EDGE IN THE DISTAL TEAR SEGMENT. ALSO THE PROXIMAL TEAR SEGMENT REVEALED EVIDENCE OF STRIATIONS WITHIN THE TEAR EDGE. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON MIGRATING IN A CIRCULAR DIRECTIONN COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION. FURTHER, THE BALLOON WAS OVER-PRESSURIZED (16 ATMOSPHERES IS RATED BURST PRESSURE FOR THIS BALLOON).
PT HAD BEEN ADMITTED THE PREVIOUS DAY AND PLACED ON CARDIAC TELEMETRY. AT APPROX 0500, THE TELEMETRY MONITOR FOR ALL OF 2ND AND PART OF 3RD FLOORS WENT DARK. PT OBSERVED AT APPROX 0515 RESTING QUIETLY AND EASILY AROUSED. PT FOUND AT APPROX. 0530 UNRESPONSIVE. CPR WAS INITIATED AND CODE CALLED. UNABLE TO RESUSCITATE AND PT PRONOUNCED DEAD AT 0549. MAINTENANCE NOTIFIED IMMEDIATELY WHEN PROBLEM OCCURRED. MONITORS RESUMED WORKING AROUND 0930.
CUSTOMER REPORTED SCREEN ROLLING. NO REPORTED PT INVOLVMENT. SERVICE REP REPAIRED DEVICE AND CONFIRMED PROPER OPERATION.
SERVICE REP REPLACED MAIN CPU BOARD AND CONFIRMED PROPER OPERATION. AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE ANY FURTHER INVESTIGAION IS REQUIRED AT THIS TIME, BUT WILL MONITOR FOR TREND. SEE DISCLAIMER.
DURING PREPPING, THE BALLOON WOULD NOT HOLD PRESSURE.
THE PRODUCT HAS NOT BEEN RETURNED TO CO FOR EVALUATION AND TESTING. THIS FILE IS CONSIDERED CLOSED. SHOULD THE PRODUCT BE RETURNED AT A LATER DATE, A FOLLOW UP WILL BE SUBMITTED FOR CO'S REVIEW.
ARTICLE ALLEGED: ALTHOUGH NOT DIRECTLY OBSERVED, IT WAS SPECULATED THAT HEMOLYTIC REACTIONS WERE CAUSED BY KINKED BLOOD LINES WHEN, UPON COMPLETION OF 4 HOURS OF DIALYSIS TREATMENT, COMPLAINTS OF ABDOMINAL PAIN, WEAKNESS, NAUSEA, GI BLEED, AND SHORTNESS OF BREATH DIC WERE EXPRESSED BY PT COMPLAINT IF THIS NATURE WERE INVESTIGATED UNDER FIR 93015. ALSO CATALOGUE #0392035 UNDER SAME COMPLAINT.
THE FOLLOWING CONCLUSIONS WERE DRAWN: CRUSHED BOXES DUE TO STACKING BOXES HIGHER THAN THE CORRUGATED MATERIAL RATING ALLOWED. BOXES DID NOT FIT ("OVERLAPPED") THE SHIPPING PALLETS. PRODUCT PACKING DENSITY TOO HIGH, LEADING TO KINKING AND DENTING OF LINES IN STERILIZATION AND STORAGE. HOWEVER THE DEGREE OF HAZARD INVOLVED DEPENDS ON THE SEVERITY OF THE KINK OR DENT. VERY SEVERE KINKS INVOLVING >85% OCCLUSION OF THE BLOODLINE HAVE BEEN SHOWN TO CAUSE HEMOLYSIS IN SOME LABORATORY TESTS. LESS SEVERE KINKS AND DENTS DID NOT CAUSE HEMOLYSIS. IN ADDITION, KINKS WERE ENOGH TO POSSIBLY CAUSE HEMOLYSIS WOULD RENDER THE BLOODLINE UNSUABLE BECAUSE THE LINE COULD NOT BE PRIMED; KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS  MACHINE WHICH WOULD CAUSE THE MACHINE TO ALARM, DUE TO OUT OF RANGE PRESSURE READING WHICH IN TURN WOULD CAUSE THE BLOOD PUMP TO STOP. CO HAS A MAJOR REPACKAGING PROJECT IN PROGRESS. THE PROJECT INCLUDES COMPLETE REVIEW OF ALL PACKAGING AND HANDLING MATERIALS PROCESSES.
PT DEVELOPED FLU-LIKE SYMPTOMS AND A FEVER OF 102 DEGREES. ON 8/12/96, PT WAS ALLEGEDLY USING AN UNSCENTED SUPER ABSORBENCY MENSTRUAL TAMPON WHEN SHE BECAME ILL. PT RECOVERED FROM HER ILLNESS WITH NO RESIDUAL EFFECTS.
THIS FORM CONTAINS INFO REPORTED TO KIMBERLY-CLARK CORP OR ONE OF ITS SUBSIDIARIES AND MAY NOT, AFTER FURTHER INVESTIGATION, REPRESENT ACTUAL FACT. NEITHER THE SUBMISSION OF THIS OR OTHER INFO TO THE FDA PURSUANT TO 21 C.F.R. 803, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY. THE LOT NUMBER IDENTIFIED BY THE INITIAL REPORTER (SEE D.3) IS NOT CONSISTENT WITH THE MFR'S CODING.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. REPORT RECEIVED FROM THE FIELD INDICATED THAT, DURING CLINICAL USE, THE BALLOON RUPTURED CIRCUMFERENTIALLY. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. THE PRODUCT WILL NOT BE RETURNED TO CO FOR EVAL AND TESTING. THIS FILE IS CONSIDERED CLOSED. SHOULD THE PRODUCT BE RETURNED AT A LATER DATE, A FOLLOW UP REPORT WILL BE SUBMITTED FOR REVIEW.
IT HAS BEEN REPORTED THAT THREE ABUTMENT SCREWS HAVE BROKEN INSIDE OF THREE IMPLANTS. THE ABUTMENT SCREWS WERE REMOVED WITHOUT ANY FURTHER SURGICAL PROCEDURES. THE IMPLANTS ARE STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
DEVICE WAS USED DURING A THORACOSCOPIC WEDGE RESECTION PROCEDURE. REPORTEDLY, THE STAPLES MALFORMED AND THE TISSUE HUNG UP ON THE CARTRIDGE SURFACE. THE APPLICATION SITE WAS RESECTED AND THE PROCEDURE COMPLETED WITH ANOTHER DEVICE. REPORTED PT STATUS AS SATISFCATORY.
THE DISPOSABLE LOADING UNIT RETURNED WAS THE FIFTH RELOAD USED WITH THE INSTRUMENT. THE PRIOR FOUR APPLICATIONS WERE SUCCESSFUL. THIS LOADING UNIT DISPLAYED DAMAGE INDICATING THAT IT HAD SHIFTED OUT OF ALIGNMENT DURING MANIPULATION IN THE THORACIC CAVITY. THIS SHIFT APPEARS TO HAVE BEEN THE RESULT OF THE USER INADVERTENTLY CONTACTING THE CARTRIDGE RELEASE BUTTON ALLOWING THE LOADING UNIT TO MOVE FORWARD THE MALFORMATION AND TISSUE HANG-UP OBSERVED. THE DEVICE WAS RELOADED AND TEST FIRED TWICE DURING EVALUATION WITH NO DISCREPANCIES NOTED.
PT RECEIVED IMPLANTS IN 1971. PT ALLEGES HAVING AN ILLNESS AND STATES SHE'S HAD TROUBLE ALL THE TIME SHE'S HAD HER IMPLANTS; HOWEVER NO SPECIFICS WERE GIVEN. SHE ALSO ALLEGES HER PROBLEMS HAVE GOTTEN WORSE LATELY AND SHE'S HAD SOME TESTS.
THE HAPTIC BROKE WHEN PLACED IN THE EYE. THE INCISION WAS ENLARGED TO 5.0 MM TO REMOVE THE LENS.
F10: CODE 1766, LABELED, CODE 1279, NOT LABELED. H6: CODE 100 = BROKEN HAPTIC. PRODUCT EVALUATION RESULTS: EVIDENCE OF SURGICAL RESIDUE. ONE HAPTIC IS SEPARATED FROM THE OPTIC. THE REMAINING HAPTIC IS BENT AND TWISTED.
PT RECEIVED IMPLANTS IN 1972. PT ALLEGES IMPLANTS WERE REMOVED IN 1986 BECAUSE SHE WAS HAVING PROBLEMS, AND STILL IS; HOWEVER, NO SPECIFIC PROBLEMS WERE GIVEN.
POLYETHYLENE SEPARATED FROM METAL BACKING CAUSING METAL WEAR AND DEBRIS.
PT WAS HOSPITALIZED WITH A HIGH FEVER, DIFFUSE ERYTHRODERMA, LOW BLOOD PRESSURE, DIZZINESS, VOMITING, DIARRHEA, MYALGIA, AND RENAL DYSFUNCTION. [T WAS DIAGNOSED WITH MENSTRUALLY-RELATED TOXIC SHOCK SYNDROME. PT WAS ALLEGEDLY USING AN UNSCENTED SUPER ABSORBENCY MENSTRUAL TAMPON WHEN SHE BECAME ILL. PT WAS DISCHARGED ON 12/24/95.
THIS FORM CONTAINS INFO REPORTED TO KIMBERLY-CLARK CORP OR ONE OF ITS SUBSIDIARIES AND MAY NOT, AFTER FURTHER INVESTIGATION, REPRESENT ACTUAL FACT. NEITHER THE SUBMISSION OF THIS OR OTHER INFO TO THE FDA PURSUANT TO 21 C.F.R. 803, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
AN EMPLOYEE OF THE FIRE DEPT WAS STUCK BY A CONTAMINATED NEEDLE WHICH PUNCTURED THROUGH THE CONTAINER. THE ACTUAL DEVICE WILL NOT BE RELEASED FOR EVAL, HOWEVER, PHOTOGRAPHS OF THE DEVICE HAVE BEEN MADE. INFO RECEIVED 8/12/96 INDICATED THE SHARPS CONTAINER HAD A NEEDLE STICKING OUT OF THE BOTTOM. THE EMPLOYEE WHO WAS STUCK WAS CARRYING THE CONTAINER INTO HOSP WHEN SHE REC'D A BAD CUT FROM NEEDLE STICKING OUT OF BOTTOM. HOSP HAS KEPT CONTAINER AND EMPLOYEE HAD PICTURES TAKEN.
CORRECTED DATA: LOT NUMBER AND SERIAL NUMBER WERE REVERSED ON THE ORIGINAL REPORT. THE SERIAL NUMBER OF THE SHARPS CONTAINER WAS THE ONLY INFO PROVIDED BY THE COMPLAINANT. MANUFACTURING WAS ABLE TO IDENTIFY THE LOT FROM THE SERIAL NUMBER. A LOT HISTORY CHECK REVEALED NO DISCREPANCIES RELATED TO THE COMPLAINT WERE OBSERVED DURING THE PRODUCTION OF THIS LOT. PHOTO'S PROMISED BY THE CUSTOMER FOR CO'S REVIEW WERE NEVER RETURNED, NOR WAS CO'S REQUEST FOR ADD'L INFO RETURNED. CO IS UNABLE TO INVESTIGATE THIS COMPLAINT ANY FURTHER, GIVEN THE LACK OF INFO AND SAMPLES. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHER MORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
PROPHYLACTICALLY REMOVED AT TIME OF SURGERY-MINIMAL WEAR WAS EVIDENT AT TIME OF SURGERY.
POLYETHYLENE CUP BEARING WORE THROUGH. REVISION SURGERY IS SCHEDULED FOR 8/30/96.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES. D.6. - EXACT SIZE OF IMPLANT IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO.
ARTICLE ALLEGED: HALF WAY THROUGH TREATMENT, PT EXHIBITED SYMPTOMS OF ABFDOMINAL PAIN, NAUSEA, VOMITING, PANCREATITIS. TREATMENT WAS DISCONTINUED. PT HOSPITALIZED. ON EXAMINATION OF THE BLOOD DEVICE A KINK IN THE BLOOD TUBING WAS FOUND BETWEEN THE BLOOD PUMP AND THE ARTERIAL DRIP CHAMBER WITH NO VENOUS PRESSURE ALARM.
THE FOLLOWING CONCLUSIONS WERE DRAWN: CRUSHED BOXES DUE TO STACKING BOXES HIGHER THAN THE CORRUGATED MATERIAL RATING ALLOWED. BOXES DID NOT FIT ("OVERLAPPED") THE SHIPPING PALLETS. PRODUCT PACKING DENSITY TOO HIGH, LEADING TO KINKING AND DENTING OF LINES IN STERILIZATION AND STORAGE. HOWEVER IN A LABORATORY TESTING, VERY SEVERE KINKS INVOLVING MORE THAN 85% OCCLUSION OF THE BLOODLINE HAVE BEEN SHOWN TO CAUSE HEMOLYSIS. LESS SEVERE KINKS DO NOT CAUSE HEMOLYSIS. IN ADDITION, KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD RENDER THE BLOODLINE UNUSABLE BECAUSE LINE COULD NOT BE PRIMED. KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD TRIGGER A SAFETY FEATURE OF THE HEMODIALYSIS MACHINE WHICH WOULD CAUSE THE MACHINE TO ALARM, DUE TO OUT OF RANGE PRESSURE READINGS AND IN TURN WOULD CAUSE THE BLOOD PUMP TO STOP. CO HAS A MAJOR REPACKAGING PROJECT IN PROGRESS. THIS PROJECT INCLUDES COMPLETE REVIEW OF THE REPACKAGING PROCESS, PACKAGING MATERIALS AND HANDLING PROCESSES.
QR AXLE MAG W/NUT. DEALER CLAIMS THAT THE QR AXLE IS BROKEN. CLAIMS THAT WHEN HE PASSED THE QR BUTTON THE BALL BEARINGS CAME OFF.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT RECEIVED IMPLANTS IN 1973. PHYSICIAN STATES SHE WANTS IMPLANTS REMOVED FOR LEGITMATE REASONS; HOWEVER, NO SPECIFICS WERE GIVEN.
CONCLUSIONS: 68 OTHER (NO DEVICE RETURNED).
A STENT PROCEDURE WAS INITIALLY PERFORMED WITHOUT INCIDENT. SOMETIME POST PLACEMENT CAUDAD MIGRATION WAS NOTED TO HAVE OCCURRED. THE STENT WAS REMOVED WITHOUT INCIDENT UTILIZING A SCOPE AND GRASPING FORCEPS. THERE WERE NO PT COMPLICATIONS INVOLVED. NO FURTHER DETAILS ARE AVAILABLE WITH REGARDS TO THE CIRCUMSTANCES SURROUNDING THIS EVENT. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY AND WILL NOT BE RETURNED FOR EVAL. WITHOUT EVALUATING THE DEVICE CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. THE ANASTOMSIS WAS DISRUPTED DURING REMOVAL OF THE DEVICE. A SECOND ANASTOMSIS WAS NOT POSSIBLE AND A COLOSTOMY WAS PERFORMED. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.
EVALUATION OF THIS DEVICE REVEALED DAMAGE TO THE KNIFE BLADE AND CUTTING RING. IN ADDITION, EVIDENCE WAS OBSERVED INDICATING THE FIRING HANDLES WERE COMPRESSED MORE THAN THE ONE TIME REQUIRED FOR A PROPER FIRING. THE DAMAGE OBSERVED IS INDICATIVE OF FIRING OF THE STAPLER OVER AN OBSTRUCTION. FIRING THE DEVICE IN THIS MANNER CAN RESULT IN THE DIFFICULTY REPORTED. THE DEVICE WAS RELOADED AND TEST FIRED WITH SATISFACTOR RESULTS. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS WHEN TESTED AT CO FACILITY.
FRACTURED ABUTMENT SCREW. IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
QR AXLE W/NUT. DEALER CLAIMS THE BEARINGS IN THE QUICK RELEASE AXLE FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ARTICLE ALLEGED: KINK WAS IDENTIFIED IN THE BLOOD LINE BETWEEN THE BLOOD PUMP SEGMENT AND INLET TO DIALYZER, FOLLOWING PT COMPLAINT OF BACK PAIN HALF WAY THROUGH TREATMENT. DIALYSIS TREATMENT WAS DISCONTINUED AND DIAGNOSIS OF HEMOLYSIS MADE.
THE FOLLOWING CONCLUSIONS WERE DRAWN M: CRUSHED BOXES DUE TO STACKING BOXES HIGHER THAN THE CORRUGATED MATERIAL RATING ALLOWED. BOXES DID NOT FIT ("OVERLAPPED") THE SHIPMENT PALLETS. PRODUCT PACKING DENSITY TOO HIGH, LEADING TO KINKING AND DENTING OF LINES IN STERILIZATION AND STORAGE. HOWEVER THE DEGREE OF HAZARD INVOLVED DEPENDS ON THE SEVERITY OF THE KINK OR DENT. VERY SEVERE KINKS INVOLVING 85% OCCLUSION OF THE BLOODLINE HAVE BEEN SHOWN TO CAUSE HEMOLYSIS IN SOME LABORATORY TESTS. LESS SEVERE KINKS DID NOT CAUSE HEMOLYSIS. IN ADDITION, KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD RENDER THE BLOODLINE UNUSABLE BECAUSE THE LINE COULD NOT BE PRIMED; KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD TRIGGER A SAFETY FEATURE OF THE HEMODIALYSIS MACHINE WHICH WOULD CAUSE THE MACHINE TO ALARM, DUE TO OUT OF RANGE PRESSURE READING WHICH IN TURN WOULD CAUSE THE BLOOD PUMP TO STOP. CO HAS A MAJOR REPACKAGING PROJECT IN PROGRESS. THE PROJECT INCLUDES COMPLETE REVIEW OF ALL PACKAGING, REPACKAGING MATERIALS AND HANDLING PROCESSES.
FRACTURED ABUTMENT SCREW. IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW HAS FRACTURED INSIDE AN IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. NO PT INJURY HAS BEEN REPORTED.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL IINSERT. THE FEMORAL COMPONENT WAS ALSO REVISED AT THIS TIME TO A COMPATIBLE TOTAL KNEE COMPONENT.
THE TIBIAL COMPONENT COULD NOT BE EVALUATED FOR THE REPORTED WEAR AS IT HAS NOT BEEN RETURNED TO CO. THE LOT CODE HAS NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE. ATTEMPTS TO OBTAIN LOT CODE INFORMATION AND/OR THE DEVICE HAVE BEEN UNSUCCESSFUL.
A STENT PLACEMENT PROCEDURE WAS INITIALLY PERFORMED WITHOUT INCIDENT. SOMETIME POST PLACEMENT CAUDAD MIGRATION WAS NOTED TO HAVE OCCURRED. THE STENT WAS REMOVED WITHOUT INCIDENT AND ANOTHER ONE WAS PLACED. THERE WERE NO PT COMPLICATIONS INVOLVED. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY AND WILL NOT BE RETURNED FOR EVAL. WITHOUT EVALUATING THE DEVICE CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
A STENT PLACEMENT PROCEDURE WAS INITIALLY PERFORMED WITHOUT INCIDENT. SOMETIME POST PLACEMENT CAUDAD MIGRATION WAS NOTED TO HAVE OCCURRED. THE STENT WAS REMOVED WITHOUT INCIDENT AND ANOTHER ONE WAS PLACED. THERE WERE NO PT COMPLICATIONS INVOLVED. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY AND WILL NOT BE RETURNED FOR EVAL. WITHOUT EVALUATING THE DEVICE WE CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
QR AXLE W/NUT. DEALER CLAIMS RETAINING BALL BEARINGS HAVE FALLEN OUT.
ARTICLE ALLEGED: KINK WAS NOTED BETWEEN THE BLOOD PUMP AND INLET TO THE DIALYZER AT ABOUT 2.5 HOUR OF TREATMENT WHEN PT START COMPLAINING OF ABACK PAIN. DIALYSIS PROCEDURE WAS TERMINATED EARLY WITH THE ONSET OF SYMPTOMNS. COMPLAINTS OF THIS NATURE WERE INVESTIGATED UNDER FIR93015. PRODUCT #0392035 UNDER SAME COMPLAINT.
THE FOLLOWING CONCLUSIONS WERE DRAWN: CRUSHED BOXES DUE TO STACKING BOXES HIGHER THAN THE CORRUGATED MATERIAL RATING ALLOWED. BOXES DID NOT FIT ("OVERLAPPED") THE SHIPMENT PALLETS. PRODUCT PACKING DENSITY TOO HIGH, LEADING TO KINKING AND DENTING OF LINES IN STERILIZATION AND STORAGE. HOWEVER IN A LABORATORY TESTING, VERY SEVERE KINKS INVOLVING MORE THAN 85% OCCLUSION OF THE BLOOD LINE HAVE BEEN SHOWN TO CAUSE HEMOLYSIS; LESS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD RENDER THE BLOODLINE UNUSABLE BECAUSE THE LINE COULD NOT BE PRIMED. KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD TRIGGER A SAFETY FEATURE OF THE HEMODIALYSIS MACHINE WHICH WOULD CAUSE THE MACHINE TO ALARM DUE TO OUT OF RANGE PRESSURE READING AND IN TURN WOULD CAUSE THE BLOOD PUMP TO STOP. CO HAS A MAJOR REPACKAGING PROJECT IN PROGRESS. THIS PROJECT INCLUDES COMPLETE REVIEW OF THE REPACKAGING PROCESS, PACKAGING MATERIALS AND HANDLING PROCESSES.
PT RECEIVED AN IMPLANT ON AN UNKNOWN DATE AND OF AN UNKNOWN MFR. PT ALLEGES HAVING A BUBBLE STICKING OUT OF HER IMPLANT AND HER DR WANTS TO DO A MAMMOGRAM.
AFTER APPLICATION OF THE BONE CEMENT, THE PT'S BLOOD PRESSURE SUDDENLY LOWERED AND THEN ROSE AGAIN. THE PT EXPIRED 30 MINS LATER.
SUMMARY OF EVALUATION: NO DETAILS OF THE PRODUCT LOT INVOLVED IN THE EVENT WERE AVAILABLE. THE ONSET OF THE PATIENT SYMPTOMS SOON AFTER APPLICATION OF THE BONE CEMENT SUGGEST AN ADVERSE REACTION TO THE PRODUCT. THIS REACTION IS KNOWN AND DOCUMENTED AND IS REFERRED TO ON THE PRODUCT INFORMATION LEAFLET. IT IS ONE OF THE MORE SERIOUS ADVERSE REACTIONS REPORTED WITH THE USE OF ACRYLIC BONE CEMENTS AND IS THOUGHT TO BE ASSOCIATED WITH RESIDUAL MONOMER IN THE CIRCULATORY SYSTEM AND EMBOLIC EFFECTS. ELDERLY OSTEOPOROTIC PATIENTS UNDERGOING JOINT REPLACEMENT OR THOSE WITH PRE-EXISTING CARDIOVASCULAR DISEASE ARE KNOWN TO BE MORE AT RISK FROM THIS REACTION.
X-TUBE ASSEMBLY 16" X 16". DEALER ALLEGES THE X-TUBES ARE BROKEN AT THE CENTER BOLT HOLE LOCATION.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
A 35 YR OLD FEMALE WITH HISTORY OF RECURRENT PNEUMOTHORAX HAD THORACOSCOPY WITH STAPLING OF PULMONARY APICAL BLEBS AND PLEURAL ABLATION ON 8/5/96. DURING THE PROCEDURE, THE STAPLER FAILED TO RE-OPEN AFTER FIRING CAUSING THE SURGEON TO CUT PT'S TISSUE FROM THE DEVICE. THE SURGEON USED THE BOVIE TO CAUTERIZE FURTHER BLEEDING POINTS. NO ADVERSE NOTED OUTCOME NOTED.
THE JAWS OF THE DEVICE WERE CLAMPED OVER A STAPLE FROM A PREVIOUS APPLICATION. THIS OBSTRUCTION BECAME LODGED BETWEEN THE ANVIL AND CARTRIDGE CAUSING EXCESSIVE INTERFERENCE BETWEEN THE TWO COMPONENTS. THIS INTERFERENCE PREVENTED THE ANVIL AND CARTRIDGE FROM READILY OPENING AFTER FIRING RESULTING IN THE DIFFICULTY EXPERIENCED. ONCE THE OBSTRUCTION WAS  REMOVED, THE JAWS OPENED AND CLOSED WITHOUT DIFFICULTY AND THE DEVICE FUNCTIONED WITHIN SPECIFICATIONS.
WHILE OPENING THE PACKAGE OF BONE CEMENT DURING SURGERY, THE THUMB OF THE "DIRTY" NURSE HIT THE TOP OF THE INNER STERILE POUCH. ANOTHER UNIT WAS READILY AVAILABLE AND SUED TO COMPLETE THE SURGERY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE CAUSE OF THIS EVENT IS ATTRIBUTED TO IMPROPER TECHNIQUE USED WHEN OPENING THE PACKAGE. THE OPENING INSTRUCTIONS ON THE POUCH HAVE BEEN MODIFIED.
IT HAS BEEN REPORTED THAT THE HEX OF AN IMPLANT WAS STRIPPED DURING PLACEMENT SURGERY. THIS EVENT FACILITATED THE IMMEDIATE REMOVAL OF THE IMPLANT. NO PT INJURY WAS REPORTED.
PT ALLEGES RECEIVING BREAST IMPLANTS ON AN UNKNOWN DATE AND OF AN UNKNOWN MFR. REPORTER ALLEGES THE PT HAD DEFECTIVE BREAST IMPLANTS.
CONCLUSION: 68 OTHER (NO DEVICFE RETURNED).
FRACTURED FIXTURE. IT HAS BEEN REPORTED THAT AN IMPLANT HAS FRACTURED. NO PT INJURY HAS BEEN REPORTED.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES.
FRACTURED ABUTMENT SCREW. IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW HAS FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. NO PT INJURY HAS BEEN REPORTED.
X-TUBE ASSM 18" X 16". DEALER CLAIMS THE X-TUBE BROKE.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT RECEIVED IMPLANTS IN 1976 AND HAD EXPLANTATION OF BOTH IMPLANTS ON 3/8/96 DUE TO SWELLING OF LEFT BREAST, MIGRATION MOVEMENT OF LEFT PROSTHESIS TO THE LEFT, RED LUMP ON LEFT BREAST AND NUMBING SENSATION DOWN LEFT ARM. TWO UNITS WERE RETURNED TO CO FOR IDENTIFICATION AND UPON VISUAL EXAMINATION BOTH DEVICES APPEARED TO BE RUPTURED.
H3-DEVICES WERE RETURNED TO CO FOR IDENTIFICATION PURPOSES AND THEN SENT BACK TO REPORTER WITHOUT FURTHER EVAL.
COMPLAINANT CLAIMED ON 7/22/96 OF INCREASED PAIN; X-RAYS SHOW INSERT WAS APPARENTLY BROKEN. DATE OF IMPLANT 5/2/89; DEVICE NOT EXPLANTED YET.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. D.6.-EXACT SIZE OF IMPLANT IS UNKNOWN BECAUSE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO.
X-TUBE ASSM 17" X 16". DEALER CLAIMS THE X-TUBE IS BROKEN AT THE CENTER AND TOP.
FOUR STENT PROCEDURES THAT WERE INITIALLY PERFORMED WITHOUT INCIDENT. MIGRATION WAS NOTED TO HAVE OCCURRED WITHIN 24 HOURS. ALL STENTS WERE REMOVED SUCCESSFULLY. THERE WERE NO PT COMPLICATIONS INVOLVED. THE DEVICES HAVE BEEN DESTROYED BY THE USER FACILITY AND WILL NOT BE RETURNED FOR EVAL. WITHOUT EVALUATING THE DEVICES CO CANNOT DETERMINE THE EXACT CAUSE FOR THESE EVENTS.
PT RECEIVED IMPLANTS ON AN UNKNOWN DATE AND HAD REMOVAL ON AN UNKNOWN DATE. DEVICES WERE RETURNED TO CO FOR IDENTIFICATION PURPOSES ONLY AND UPON VISUAL EXAMINATION THE RIGHT IMPLANT APPEARED TO BE INTACT WITHOUT FULL SHELL INTEGRITY AND THE LEFT IMPLANT APPEARED TO BE INTACT WITH UNKNOWN SHELL INTEGRITY. DEVICES WERE RETURNED TO REPORTER WITHOUT FURTHER EVAL.
H3-DEVICES WERE RETURNED TO CO FOR IDENTIFICATION PURPOSES ONLY AND THEN SENT BACK TO REPORTER WITHOUT FURTHER EVAL.
ARTICLE ALLEGED: ALTHOUGH NOT OBSERVED, IT WAS SPECULATED THAT HEMOLYTIC REACTIONS WERE CAUSED BY KINKED BLOOD LINES, WHEN A PT AFTER COMPLETION OF 4 HOUR DIALYSIS SESSIONS, COMPLAINED OF ABDOMINAL PAIN, NAUSEA, DIC, GI BLEED, PANCREATITIS. PT WAS HOSPITALIZED AND EXPIRED. COMPLAINTS OF THIS NATURE WERE INVESTIGATED UNDER FIR 93015. PRODUCT #0392035 UNDER SAME COMPLAINT.
THE FOLLOWING CONCLUSIONS WERE DRAWN: CRUSHED BOXES DUE TO STACKING BOXES HIGHER THAN THE CORRUGATED MATERIAL RATING ALLOWED. BOXES DID NOT FIT ("OVERLAPPED") THE SHIPMENT PALLETS. PRODUCT PACKING DENSITY TOO HIGH, LEADING TO KINKING AND DENTING OF LINES IN STERILIZATION AND STORAGE. HOWEVER IN A LABORATORY TESTING, VERY SEVERE KINKS INVOLVING MORE THAN 85% OCCLUSION OF THE BLOOD LINE HAVE BEEN SHOWN TO CAUSE HEMOLYSIS; LESS SEVERE KINKS DID NOT CAUSE HEMOLYSIS. IN ADDITION, KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD RENDER THE BLOOD LINE UNUSABLE BECAUSE THE LINE COULD NOT BE PRIMED; KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD TRIGGER A SAFETY FEATURE OF THE HEMODIALYSIS MACHINE WHICH WOULD CAUSE THE MACHINE TO ALARM DUE TO OUT OF RANGE PRESSURE READING AND IN TURN WOULD CAUSE THE BLOOD PUMP TO STOP. CO HAS A MAJOR REPACKAGING PROJECT IN PROGRESS. THIS PROJECT INCLUDE COMPLETE REVIEW OF THE REPACKAGING PROCESS, PACKAGING MATERIALS AND HANDLING PROCESSES.
A PT DIAGNOSED WITH GESTATIONAL DIABETES, WHO HAS SINCE GIVEN BIRTH, TESTED GLUCOSE AT 9:45 PM, WITH THE SUSPECT DEVICE AND OBTAINED A VALUE OF 270 MG/DL. SHE TOOK 15 U HUMULIN. AT 2 AM HER HUSBAND TOOK HER TO THE EMERGENCY ROOM BECAUSE OF A SEIZURE. THE DEVICE READ 173 MG/DL GLUCOSE, WHILE THE HOSP METER (UNKNOWN DEVICE) READ 40 MG/DL. HOSP PERSONNEL ADMINISTERED DEXTROSE INTRAVENOUSLY.
X-TUBE ASSEMBLY 17" X 18". DEALER ALLEGES THE X-TUBE IS BROKEN AT LEFT SIDE BOTTOM WELD.
PT UNDERWENT CATARACT SURGERY ON 8/8/96, AND IMPLANTATION OF A MODEL AQ-2003V INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON NOTICED THAT THE HAPTIC WAS BENT AFTER INSERTION AND CAUSED A POSTERIOR CAPSULAR TEAR. THE SURGEON PERFORMED AN ANTERIOR VITRECTOMY. THE SURGEON REMOVED THE LENS AND REPLACED IT WITH ANOTHER LENS. NO OTHER SURGICAL PROCEDURES WERE PERFORMED.
H6-RESULTS OTHER: THE LENS HAD DRIED BSS/VISCOELASTIC TYPE RESIDUE PRESENT. ONE HAPTIC WAS BENT BEYOND SPECS, POSSIBLY DUE TO MISALIGNMENT IN THE LOADING AREA. H6-CONCLUSION OTHER: THE HAPTIC DAMAGE MAY HAVE RESULTED FROM MISALIGNMENT IN THE CARTRIDGE PRIOR TO INSERTION. THE RUPTURED CAPSULE MAY HAVE RESULTED FROM THE IMPROPER LENS CONFIGURATION AND SUBSEQUENT DELIVERY CAUSED BY THE MISALIGNMENT. THE PT'S VISUAL ACUITY AT ONE DAY POSTOP WAS 20/50 UNCORRECTED AND PRESSURE WAS 17 MM HG. AT THE SIX DAY POSTOP EXAM HER VISUAL ACUITY WAS 20/80 UNCORRECTED AND 20/40 CORRECTED. PRESSURE AT SIX DAYS POSTOP WAS 14 MM HG. THE SURGEON OBSERVED TRACE CELLS IN THE ANTERIOR CHAMBER DURING THE SIX DAY POSTOP EXAM. PROGNOSIS IS GOOD. THE RATE OF OCCURRENCE OF THIS EVENT CANNOT BE DETERMINED AS IT IS NOT ADDRESSED IN THE PRODUCT LABELING. LENS BOX WAS RECEIVED. THE BOX CONTAINED 6 CHART LABELS, THE PT REGISTRATION CARD, AND THE LENS TRAY. THE LENS TRAY CONTAINED THE LENS, HELD IN BY TAPE. THE LENS WAS REMOVED FROM THE TRAY AND INSPECTED TO DETERMINE IF A BENT HAPTIC CAUSED A RUPTURED CAPSULE. THE LENS HAS DRIED BSS/VISCOELASTIC RESIDUE. ONE HAPTIC WAS TORQUED AND BENT BEYOND SPECS. THE HAPTIC DAMAGE MAY HAVE RESULTED FROM CONTACT WITH THE INJECTOR PLUNGER. THIS USUALLY OCCURS WHEN THE HAPTIC/OPTIC ARE NOT PROPERLY ALIGNED IN THE CARTRIDGE LOADING AREA. AS THE LENS IS ADVANCED IN THE CARTRIDGE, THE PLUNGER MOVES THE LENS VIA THE HAPTIC (AND NOT THE OPTIC). HOWEVER, THE RUPTURED CAPSULE MAY HAVE RESULTED FROM THE IMPROPER LENS CONFIGURATION AND SUBSEQUENT DELIVERY CAUSED BY THE MISALIGNMENT.
X-TUBE ASSM 18" X 16" DEALER CLAIMS X-TUBE BROKE.
A FEMALE TYPE II DIABETIC WAS FEELING ILL AND LIGHT-HEADED. ON HER DR'S RECOMMENDATION SHE WENT TO THE ER WHERE SHE WAS TREATED WITH IV (SUGAR) AND OTHER MEDICATIONS OF UNKNOWN ORIGIN. THE METER USED IN THE ER GAVE A READING OF 32 MG/DL (TIME OF READING UNKNOWN). THE PT'S OWN DEVICE GAVE READINGS THROUGHOUT THE DAY AS INDICATED BELOW. PT HAD SKIPPED HER USUAL EVENING SNACK. PT RAN CONTROLS ON THE DEVICE WHEN SHE GOT IT 28 DAYS AGO AND ALL VALUES WERE IN RANGE. THE PT HAS NOT CLEANSED THE UNIT BECAUSE SHE DID NOT SEE ANY BLOOD ON IT. PT ALSO CLAIMS TO UNDERDOSE THE UNIT.
ARTICLE ALLEGED: ALTHOUGH NOT DIRECTLY OBSERVED, IT WAS SPECULATED THAT HEMOLYTIC REACTIONS WERE CAUSED BY KINKED BLOODLINES WHEN UPON COMPLETION OF 4 HOURS OF DIALYSIS TREATMENT, COMPLAINTS OF ABDOMINAL PAIN, GI BLEED, PANCREATITIS WERE EXPRESSED BY PT. COMPLAINTS OF THIS NATURE WERE  INVESTIGATED UNDER FIR #93015. PRIDCT #0392035 UNDER SAME COMPLAINT.
THE FOLLOWING CONCLUSIONS WERE DRAWN: CRUSHED BOXES DUE TO STACKING BOXES HIGHER THAN THE CORRUGATED MATERIAL RATING ALLOWED. BOXES DID NOT FIT ("OVERLAPPED") THE SHIPPING PALLETS. PRODUCT PACKING DENSITY TOO HIGH, LEADING TO KINKING AND DENTING OF LINES IN STERILIZATION AND STORAGE. HOWEVER IN A LABORATORY TESTING, VERY SEVERE KINKS INVOLVING MORE THAN 85% OCCLUSION OF THE BLOOD LINE HAVE BEEN SHOWN TO CAUSE HEMOLYSIS; LESS SEVERE KINKS DID NOT CAUSE HEMOLYSIS. IN ADDITION, KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD RENDER THE BLOOD LINE UNUSABLE BECAUSE THE LINE COULD NOT BE PRIMED, KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD TRIGGER A SAFETY FEATURE OF THE DIALYSIS MACHINE WHICH WOULD CAUSE THE MACHINE TO ALARM DUE TO OUT OF RANGE PRESSURE READING AND IN TURN WOULD CAUSE THE BLOOD PUMP TO STOP. CO HAS A MAJOR REPACKAGING PROJECT IN PROGRESS. THIS PROJECT INCLUDES A COMPLETE REVIEW OF THE REPACKAGING PROCESS, PACKAGING MATERIALS AND HANDLING PROCESSES.
X-TUBE ASSM 20" X 17" DEALER CLAIMS X-TUBE BROKE.
PT RECEIVED BREAST IMPLANTS ON 4/27/84. DURING A ROUTINE MAMMOGRAM IN MARCH OF THIS YR (1996), IT WAS DISCOVERED THAT THE PT'S RIGHT IMPLANT WAS RUPTURED. THIS WAS ALSO CONFIRMED WITH AN MRI. BOTH IMPLANTS WERE SUBSEQUENTLY REMOVED IN 5/1996. THE RUPTURE OCCURRED WITHIN THE LAST 14 MONTHS.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
X-TUBE ASSM 20" X 17" DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
X-TUBE ASSM 18" X 17" DEALER CLAIMS X-TUBE BROKE AT CENTER OF THE BOLT.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
AN ABUTMENT BROKE DUE TO OVERLOAD. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-00042.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS COMPLETED AND FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
ARTICLE ALLEGED: ALTHOUGH NOT DIRECTLY OBSERVED, IT WAS SPECULATED THAT HEMOLYTIC REACTION WERE CAUSED BY KINKED BLOODLINE WHEN UPON COMPLETION OF 4 HOURS OF DIALYSIS TREATMENT, COMPLAINTS OF ABDOMINAL PAIN, NAUSEA WERE EXPRESSED BY PT. COMPLAINTS OF THIS NATRUE WERE INVESTIGATED UNDER FIR 93015. PRODUCT#0392035 UNDER SAME COMPLAINT.
THE FOLLOWING CONCLUSIONS WERE DRAWN: CRUSHED BOXES DUE TO STAKCING BOXES HIGHER THAN THE CORRUGATED MATERIAL RATING ALLOWED. BOXES DID NOT FIT ("OVERLAPPED") THE SHIPPING PALLETS. PRODUCT PACKING DENSITY TOO HIGH LEADING TO KINKING AND DENTING OF LINES IN STERILIZATION AND STORAGE. HOWEVER IN A LABORATORY TESTING ONLY VERY SEVERE KINKS INVOLVING >85% OCCLUSION OF THE BLOOD LINE HAVE BEEN SHOWN TO CAUSE HEMOLYSIS; LESS SEVERE KINKS DID NOT CAUSE HEMOLYSIS. IN ADDITION, KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD RENDER THE BLOOD LINE UNUSABLE BECAUSE THE LINE COULDNOT BE PRIMED; KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD TRIGGER A SAFETY FEATURE OF THE DIALYSIS MACHINE WHICH WOULD CAUSE THE MACHINE TO ALARM DUE TO OUT OF RANGE PRESSURE READING AND IN TURN WOULD CAUSE THE BLOOD PUMP TO STOP. CO HAS A MAJOR REPACKAGING PROJECT IN PROGRESS. THIS PROJECT INCLUDES COMPLETE REVIEW OF THE REPACKAGING  PROCESS, PACKAGING MATERIALS AND HANDLING PROCESSES.
H3-DEVICE RETURNED FOR IDENTIFICATION PURPOSES ONLY AND THEN SENT BACK TO REPORTER WITH NO FURTHER EVAL.
PHYSICIAN STATES PT DEVELOPED JOINT STIFFNESS AND SORENESS RECENTLY AND WAS ALSO CONCERNED WITH POSSIBILITY OF RUPTURED PROSTHESIS (FULLNESS UNDER THE AXILLAE). THE RIGHT IMPLANT WAS RETURNED TO DOW CORNING FOR IDENTIFICATION AND UPON VISUAL EXAMINATION THE DEVICE APPEARED TO BE RUPTURED. DEVICE WAS RETURNED TO AUSTRIALIA WITH NO FURTHER EVALUATION.
THE PT WAS IMPLANTED WITH A PROSTHESIS ON 2/23/96. ON 8/9/96 THE PHYSICIAN NOTED THAT DEVICE HAD MIGRATED. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
SUBMISION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY, CO EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO. ADD'L INFO TO BE SUBMITTED Y/N? Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELEING? N.
X-TUBE ASSM 18" X 17" DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
AN ABUTMENT BROKE DUE TO OVERLOAD. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-00041.
A REPORT WAS RECEIVED INVOLVING IMPLANT. HYDROXYAPATITE BONE VOID FILLER BLOCK WAS USED TO REPAIR A SEVERELY COMMINUTED (SCHATZKER TYPE IV) PROXIMAL TIBIAL FRACTURE. THE PT DEVELOPED A NECROTIC WOUND DEHISCENSE APPROX 3 WKS POST-OPERATIVELY. THE DR STATED THAT THE PT'S HEAVY SMOKING HABITS CAUSED THE DEHISCENSE. THE PT RETURNED TO THE HOSP 3 TIMES FOR IRRIGATION AND DEBRIDEMENT. FOLLOWING THE LAST DEBRIDEMENT THE WOUND WAS CLOSED USING A FREE VASCULAR RECTUS GRAFT TRANSFERRED TO THE DEHISCENSE SITE. THE WOUND HEALED BUT CONTINUED TO DRAIN. THE PT WAS PLACED ON A 6 WK I.V. COURSE OF ANTIBIOTICS AND WAS DISCHARGED HOME. THE PT THEN CONTINUED ON ORAL ANTIBIOTICS. ADD'L SURGERY ON 6/20/96, NOTED INFECTION AND BONE NECROSIS. A CULTURE TAKEN AT THE TIME OF SURGERY TESTED POSITIVE FOR PEPTOSTREPTOCOCCUS. THE FILLER, LATERAL PLATE AND SCREWS, AND NECROTIC BONE WERE REMOVED. THE DR STATED THAT ALTHOUGH THE PRESENCE OF PRO OSTEON MAY  HAVE EXACERBATED THE INFECTION (I.E. AN AREA WHERE THE INFECTION MIGHT HARBOR), THE SAME OUTCOME WOULD HAVE BEEN REACHED USING AUTOGRAFT THAT ULTIMATELY DID NOT VASCULARIZE.
BLOCK H.6 86=PRODUCT NOT RETURNED FOR EVAL/NO EVAL PERFORMED. 50=DR STATED THAT PT NONCOMPLIANCE (SMOKING) CAUSED EVENT.
SOURCE HAS BEEN FAXED THIS MEDWATCH REPORT. NO FURTHER INFO AT THIS TIME. CONDITION RECEIVED: USED. INVESTIGATION: IMPLANT UP TO CO'S SPECS. ANALYSIS SUMMARY: NOT ATTRIBUTED TO PRODUCT. CORRECTIVE ACTION: PER DR., BONE QUALITY, POROSITY AND POOR RIDGE WERE FACTORS IN FAILURE. PREVENATATIVE ACTION: NONE.
IMPLANT WAS PLACED ON 9/6/95 AND WAS REMOVED ON 7/1/96.
PHYSICIAN STATES PT DEVELOPED JOINT STIFFNESS AND SORENESS RECENTLY AND WAS ALSO CONCENED WITH THE POSSIBILITY OF RUPTURED PROSTHESIS (FULLNESS UNDER THE AXILLAE). REPORT ALLEGES PT WAS TO RETURN LEFT IMPLANT FOR ID BUT ONLY SENT THE RIGHT ONE AS THE LEFT "WAS NOT SALVAGEABLE TO RETURN."
FRACTURED ABUTMENT SCREWS. IT HAS BEEN REPORTED THAT TWO ABUTMENT SCREWS FRACTURED INSIDE TWO IMPLANTS. THE SURGEON HAD TO PERFORM AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREWS FROM THE IMPLANTS. THE IMPLANTS ARE STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
ARTICLE ALLEGED: ALTHOUGH NOT DIRECTLY OBSERVED, IT WAS SPECULATED THAT HEMOLYTIC REACTIONS WERE CAUSE BY KINKED BLOODLINE WHEN UPON COMPLETION OF 4 HOURS OF DIALYSIS TREATMENT, COMPLAINT OF ABDOMINAL PAIN, VOMITING, GI BLEED PANCREATITIS WERE EXPRESSED BY PT. COMPLAINTS OF THIS NATURE WERE INVESTIGATED UNDER FIR 93015. PRODUCT #0392035 UNDER SAME COMPLAINT.
THE FOLLOWING CONCLUSIONS WERE DRAWN: CRUSHED BOXES DUE TO STACKING BOXES HIGHER THAN THE CORRUGATED MATERIAL RATING ALLOWED. BOXES DID NOT FIT ("OVERLAPPED") THE SHIPPING PALLETS. PRODUCT PACKING DENSITY TOO HIGH LEADING TO KINKING AND DENTING OF LINES IN STERILIZATION AND STORAGE. HOWEVER IN A LABORATORY TESTING, VERY SEVERE KINKS INVOLVING GREATER THAN 85% OCCLUSION OF THE BLOOD LINE HAVE BEEN SHOWN TO CAUSE HEMOLYSIS; LESS SEVERE KINKS DID NOT CAUSE HEMOLYSIS. IN ADDITION, KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD RENDER THE BLOOD LINE UNUSABLE BECAUSE THE BLOOD LINE COULD NOT BE PRIMED; KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD TRIGGER A SAFETY FEATURE OF THE HEMODIALYSIS MACHINE WHICH WOULD CAUSE THE MACHINE TO ALARM DUE TO OUT OF RANGE PRESSURE READING AND IN TURN WOULD CAUSE THE BLOOD PUMP TO STOP. CO HAS A MAJOR REPACKAGING PROJECT IN PROGRESS. THIS PROJECT INCLUDES COMPLETE REVIEW OF THE REPACKAGING PROCESS, PACKAGING MATERIALS AND HANDLING PROCESSES.
A CONSUMER PUT ON A PAIR OF CO'S SUNGLASSES. LEFT LENS WAS APPARENTLY CRACKED. WHILE PLACING THE GLASSES ON HIS FACE AND OPENING THE TEMPLES A CHIP FROM THE LENS STRUCK HIS LEFT EYE CAUSING IRRITATION. MEDICAL ATTENTION WAS SOUGHT AND A CORNEAL SCRATCH WAS DIAGNOSED. THE EYE WAS TREATED, AND THE SCRATCH HAS SINCE HEALED, AND NO FURTHER TREATMENT IS TAKING PLACE.
ALL CO SUNGLASS LENSES ARE CHEMTEMPERED AND 100% FDA DROPBALL TESTED PRIOR TO BEING SOLD. CO STATES ON HANGTAGS FOR GLASSES THAT "LENSES MEET CONN. SGSTD40 AND FDA IMPACT REQUIREMENTS BUT ARE NOT SHATTERPROOF." "DO NOT WEAR FOR NIGHT DRIVING OR AS SAFETY GLASSES." EVENT FREQUENCY: THE FREQUENCY OF OCCURENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. THE FREQUENCY OF THIS EVENT IS NOT GREATER THAN USUAL. EVENT SEVERITY: THE SEVERITY OF OCCURRENCE OF THIS EVENT IS NOT ADDRESSED IN THE DEVICE LABELING. THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL. THIS EVENT INVOLVED ONE PERSON.
DURING THE UNCOVERY OF THIS IMPLANT, HE WAS GETTING READY TO PLACE THE TEMPORARY GINGVAL CUFF WHEN HE SAW THAT THE IMPLANT WAS MOBILE. THE BODY WAS REMOVED. NO INDICATIONS THAT THE IMPLANT HAD ANY PROBLEMS. PT IS REPORTEDLY FINE.
FRACTURED ABUTMENT SCREW. IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW HAS FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
THE BALLOON HAD BEEN IN PLACE FOR 10 DAYS IN A PT WITH A LARGE INTERIOR MI. DURING BALLOON REMOVAL, RESISTANCE WAS ENCOUNTERED AND WHEN THE CATHETER WAS REMOVED, THE BALLOON MEMBRANE REMAINED (BALLOON WAS ENTRAPPED). PT HAD SURGERY FOR EXTRACTION OF BALLOON AND FEMORAL ARTERY REPAIR. THE BALLOON WAS SENT TO PATHOLOGY FOR EXAM. A LARGE DARK MASS WAS FOUND INSIDE THE BALLOON. THE PT DID EXPIRE BUT HOSP PERSONNEL FEEL IT IS UNRELATED TO THE INCIDENT.
MFR CONTROL NO DI96-178, THE PRODUCT SERIAL NUMBER INDICATED ON THE ATTACHED USER FACILITY MED WATCH REPORT IS NOT A VALID NUMBER.
FRACTURED ABUTMENT SCREW. IT HAS BEEN REPORTED THAT TWO ABUTMENT SCREWS FRACTURED INSIDE TWO IMPLANTS. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
PT HAD INTRA-AORTIC BALLOON PUMP PLACED 7/31/96. BY 8/5/96 PT'S BLOOD PRESSURE HAD STABILIZED SO ATTEMPTED REMOVAL. RESISTANCE WAS NOTED-PT TAKEN TO OR FOR SURGICAL REMOVAL. LARGE 3" X 1/2" DARK RED-BROWN SUBSTANCE NOTED WITHIN IAB CATHETER. SENT TO PATHOLOGY FOR ANALYSIS.
THIS ENTIRE FORM COMPLETED BY MFR. SEC H3 VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED APPROX 12 MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX 76 MM AND HAS MIGRATED DOWN LEAD BODY APPROX 20 MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO APPROX 88 MM. VISUAL INSPECTION UNDER 30 X MAGNIFICATION ALSO INDICATES THE LEAD WAS SNIPPED OR CUT APPROX CM PROXIMAL OF FIXATION HELIX HOUSING ELECTRODE TIP, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURE.
AN IMPLANT FAILED DUE TO BONE LOSS. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS NOT POSSIBLE BECAUSE LOT NUMBER WAS NOT AVAILABLE FROM DR.
NOTE: EVAL OF THIS OCCURRENCE IS THE RESPONSIBILITY OF THE PRODUCT MFR. ACCORDING TO THIS MFR'S PROCEDURES, ALL INFO CONCERNING THIS EVENT AND/OR THE DEVICE COMPONENTS REC'D HAVE BEEN RETURNED TO THE SENDER.
UPON EXAMINATION OF THE DEVICE REC'D, IT WAS DETERMINED THAT THIS PROSTHESIS IS A NON-MENTOR MFG DEVICE. NOTE: DETERMINATION OF REPORTABILITY AND CATEGORIZATION OF THIS EVENT WAS MADE ACCORDING TO THIS MFR'S POLICIES AND PROCEDURES AND THE INFO REC'D IN COMPLIANCE WITH MED DEVICE REPORTING REGULATIONS. THESE DETERMINATIONS ARE NOT INTENDED TO EVALUATE THIS OCCURRENCE OR SUGGEST A CAUSE (REF SECTINS B2,B2 H1).
FRACTURED ABUTMENT SCREW. IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW FRACTURED INSIDE AND IMPLANT. THE SCREW FRAGMENT COULD NOT BE REMOVED FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. A CUSTOM DESIGN SCREW WAS FABRICATED AS A REPLACEMENT SO THAT THE IMPLANT COULD CONTINUE TO BE FUNCTIONAL. PT INJURY HAS NOT BEEN REPORTED.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
THE CATHETER WAS INSERTED ON 7/22. IT WAS FUNCTIONING WELL UNTIL 8/1 WHEN THERE WAS A HIGH PRESSURE ALARM AND BLOOD INFLOW INTO THE TUBING. THERE WAS NO HELIUM LEAKAGE SIGNAL TO INDICATE LEAKING. CATHETER WAS CLAMPED IMMEDIATELY. WHEN PHYSICIAN REMOVED CATHETER FROM PT THE BALLOON WAS PARTIALLY INFLATED IN SPITE OF SUCKING OUT GAS BEFORE REMOVAL. PT DEVELOPED SHORTNESS OF BREATH AND CHEST PAIN. THN S.L. GIVEN TO PT. BIPAP VENTILATOR WAS APPLIED TO IMPROVE PT'S VENTILATION. THERE WERE NO COMPLICATIONS.
THE PT IS EXPERIENCING A "LEAK WITHIN THE SYSTEM OF HIS DEVICE. ON 8/21/96 THE PT UNDERWENT A "PERCUTANEOUS FLUID ADJUSTMENT" IN THE PHYSICIAN'S OFFICE TO PROVIDE THE PT WITH SHORT-TERM FUNCTION OF THE PROSTHESIS. HOWEVER, SURGERY IS SCHEDULED FOR 9/25/96 TO POSSIBLY REMOVE AND REPLACE THE ENTIRE DEVICE TO CURE THE REPORTED "LEAK".
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT SURGICAL INTERVENTION OCCURRED ON 09/25/96 (SEE SECTIONS B3; B5; G4; G7; AND H2; H7). EVALUATION AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE. IN THE RECEIVED QUESTIONNAIRE, THE PHYSICIAN STATED THE FOLLOWING: THERE WAS NOT SPECIFIC LEAKAGE SITE OBSERVED; THE PHYSICIAN STATED THE FOLLOWING: THERE WAS NO SPECIFIC LEAKAGE SITE OBSERVED; THE TUBING WAS NOT KINKED OR TWISTED AROUND EACH OTHER WHEN HE OPENED THE POCKET; DURING IMPLANTATION THERE WAS NO NOTICEABLY EXCESSIVE NOR INADEQUATE TUBING LENGTH; NOTHING WAS NOTED IN THE POSITIONING THAT MAY HAVE CAUSED STRESS(ES) TO THE DEVICE: NO INFORMATION IN THE PT'S HISTORY MAY HAVE CONTRIBUTED TO THIS OCCURRENCE, AND DURING OR SUBSEQUENT TO REMOVAL THE DEVICE WAS NOT IN CONTACT WITH ANY UNSHOD, SHARP INSTRUMENTATION. THE ENTIRE DEVICE WAS RECEIVED AN EVALUATED BY THE MANUFACTURER. DURING FUNCTIONAL TESTING, TWO LEAKAGE SITES WERE OBSERVED WITH THE DEVICE. ONE LEAKAGE SITE EXISTED AT THE STAIN RELIEF JUNCTION OF THE SERIALIZED OUTLET. THE OTHER, WAS LOCATED IN THE BLADDER OF THE PUMP. A MICROSCOPIC EXAMINATION OF THE LEAKAGE SITES WAS PERFORMED. THERE WAS A SEPARATION OF THE INNER AND OUTER LAYERS OF TUBING BY THE STRAIN RELIEF JUNCTION. THE CROSS SECTIONAL SURFACES OF THIS SEPARATION SITE WERE ROUGH AND IRREGULAR, INDICATING A TEAR OF THE TUBING. AN  AREA OF ABRASION WAS ALSO LOCATED BY THIS SEPARATION/LEAKAGE/TEAR SITE. THE PUMP LEAKAGE SITE WAS CRESCENT MOON SHAPED. THE CROSS SECTIONAL SURFACE OF THIS SEPARATION SITE SHOWED UNIFORM STRIATIONS, INDICATING CONTACT WITH SHARP INSTRUMENTATION, E.G. NEEDLE. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCE'S EXAMINATION, QA CONCLUDES THAT WHILE IN-VIVO THE SERIALIZED OUTLET TUBING WAS ABRADING. THE STRESS(ES) CAUSED BY THIS ABRASION IN TURN CAUSED A TUBING TEAR AT THE SERIALIZED STRAIN RELIEF JUNCTION. THIS TEAR RESULTED IN A FLUID LEAK. THE DROP IN FLUID LEVEL WAS THEN ADJUSTED WITH THE PERCUTANEOUS FLUID ADJUSTMENT. HOWEVER, DURING THIS ADJUSTMENT, THE PUMP BLADDER MAY HAVE CONTACTED SHARP INSTRUMENTATION, E.G. NEEDLE. THEN, THE DEVICE LEAKED FLUID FROM THE STRAIN RELIEF AND THE PUMP BLADDER.
THE DEVICE WAS REMOVED AS IT WAS "DEFECTIVE". THE ENTIRE DEVICE WAS REMOVED.
ACCORDING TO THE AVAILABLE INFO THIS DEVICE WAS IMPLANTED ON 4/26/90 AND REMOVED ON 7/17/96 BECAUSE IT WAS "DEFECTIVE." REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE DEVICE REVEALED NO FUNCTIONAL ABNORMALITIES. BASED ON THIS QA CONCLUDED THAT NO FUNCTIONAL ABNORMALITIES CONTRIBUTED TO THIS EVENT. BECAUSE THE LIMITED INFO DOES NOT PROVIDED ANY INDICATION WHAT FACTOR(S) MAY HAVE CONTRIBUTED TO THE DEVICE BEING "DEFECTIVE," AND BECAUSE NO FUNCTIONAL ABNORMALITIES WERE DETECTED, QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED EVENT.
SUSPECTED MFG DEFECT. THESE LAMPS ARE IDENTIFIED AS REPLACEMENT BULBS FOR A SPECIFIC BRAND DENTAL OPERATING LIGHTS. HOWEVER, THE LAMPS ARE OF INSUFFICIENT LENGTH TO MAKE FIRM CONTACT WITH THE LAMP HOLDER SOCKETS WHICH CREATES AN INTERMITTENT CONTINUITY CONDITION. THIS LEADS TO ELECTRICAL ARCING AND SUBSEQUENT CARBON BUILD UP ON THE SOCKET AND BULB CONTACT SURFACES. THIS CONDITION REQUIRES REPLACEMENT OF BOTH THE SOCKETS AND BULB. ADDING TO THE PROBLEM IS POOR QUALITY FINISH ON THE BULB ENDS WHICH HASTEN THE CARBON BUILD UP. WORK ORDER REVIEW INDICATES 18 SOCKETS WERE REPLACED DUE TO THIS CONDITION, AT $ 27.00 EACH, IN THE LAST SIX MONTHS.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE PRODUCT BECAME STIFF TO WIND DURING OPERATION AND HAS CAUSED INJURY TO A NURSE'S NECK. THE NURSE HAS LOST TIME FROM WORK DUE TO THE INJURY. ONE PERSON INVOLVED NOT A PT.
CAUSE OF EVENT WAS DETERMINED TO BE USER ERROR. IMPROPER TRAINING GIVEN ON USE OF DEVICE. CUSTOMER IS TO REFER TO OPERATIONAL MANUAL FOR RETRAINING ON CORRECT OPERATION OF DEVICE. FOREIGN REPORTER IS TO FORWARD ALL INFO PERTAINING TO INCIDENT. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IN USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT GREATER THAN LABELED? IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL?Y. ADD'L INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT. DISCLAIMER: THIS REPORT IS BASED ON IFORMATION SUPPLIED TO US WITHOUT INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21CFR600, 803,1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
THE FIRST INDICATED PROBLEMS WERE LEAKING OF THE 3-WAY SYRINGE. DISCUSSIONS BETWEEN CO AND USER RESULTED IN REPORTEDLY INCORRECT ASSEMBLY/REPAIR IN THE FIELD. OTHER LOCATIONS HAVE NOW REPORTED PROBLEMS WITH THE STEM, DUAL POPPING OUT OF THE DUAL SYRINGE HEAD WHEN AIR PRESSURE IS APPLIED. PRELIMINARY INFO INDICATES THAT THE O-RING COMES OFF AND ALLOWS THE BUTTON AND SHAFT ALONG WITH THE SPRING TO POP OUT THE HEAD. THIS HAS OCCURRED ON UNITS OUT OF STOCK, THEREFORE ELIMINATING ANY POSSIBILITY OF INCORRECT MAINTENANCE PROCEDURES. THE MFR HAS PROVIDED NEW ASSEMBLIES AS NEEDED BUT A FIX NEEDS TO BE IDENTIFIED AND APPLIED ACROSS ALL ASSETS. DUE TO MISSION REQUIREMENTS, IT IS TOO LATE TO FIX AFTER IT BREAKS.
QR AXLE MAG W/NUT DEALER ALLEGES QUICK RELEASE AXLE DOES NOT WORK. THE BEARING BALLS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYESS CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
AN ABUTMENT LOCATED IN #19 AREA BROKE IN FUNCTION. ABUTMENT IS BROKEN AT THE THE WELD JOINT. PT IS SAME PT AS PRIOR MDR REPORTS#M589707 AND M737069.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPOMENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO IS UNABLE TO REVIEW PRODUCT'S LOT HISTORY SINCE THE LOT NUMBER WAS UNAVAILABLE FROM DOCTOR'S OFFICE.
THE DEVICE WAS REMOVED DUE TO AN INFECTION". "NOTHING WAS WRONG WITH THE PROSTHESIS.
REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL REEVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISAPROVE THE REPORT OF INFECTION, QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE AVAILABLE INFO, QA ACCEPTS THE INFECTION REPORT. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QA INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
ARTICLE ALLEGED: COMPLAINT OF BACK PAIN, NAUSEA, VOMNITING, PANCREATITIS WERE ESPRESSED BY PT AFTER 4 HOURS OF DIALYSIS TREATMENT. ALTHOUGH NOT DIRECTLY OBSERVED, IT WAS SPECULATED THAT HEMOLYTIC REACTIONS WERE CAUSED BY KINKED BLOOD LINES. COMPLAINTS OF THIS NATURE WERE INVESTIGATED UNDER FIR #93015. PRODUCT #0392035 UNDER SAME COMPLAINT.
THE FOLLOWING CONCLUSIONS WERE DRAWN: CRUSHED BOXES DUE TO STACKING BOXES HIGHER THAN THE CORRUGATED MATERIAL RATING ALLOWED. BOXES DID NOT FIT ("OVERLAPPED") THE SHIPPING PALLETS. PRODUCT PACKING DENSITY TOO HIGH, LEADING TO KINKING AND DENTING OF LINES IN STERILIZATION AND STORAGE. AS A CORRECTIVE ACTION(S), A MAJOR REPACKAGING PROJECT IS IN PROGRESS. THE PROJECT INCLUDE COMPLETE REVIEW AND REDESIGN OF THE PACKAGING PROCESS, PACKAGING MATERIALS AND HANDLING PROCESS. HOWEVER IN A LABORATORY TESTING, VERY SEVERE KINKS INVOLVING >85% OCCLUSION OF THE BLOOD LINE HAVE BEEN SHOWN TO CAUSE HEMOLYSIS; LESS SEVERE KINKS DID NOT CAUSE HEMOLYSIS, IN ADDITION, KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD RENDER THE BLOOD LINE UNUSABLE BECAUSE THE LINE COULD NOT BE PRIMED; KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD TRIGGER A SAFETY FEATURE OF THE HEMODIALYSIS MACHINE WHICH WOULD CAUSE THE MACHINE TO ALARM DUE TO OUT OF RANGE PRESSURE READING, AND IN TURN WOULD CAUSE THE BLOOD PUMP TO STOP. CO HAS A MAJOR REPACKAGING PROJECT IN PROGRESS WHICH INCLUDES COMPLETE REVIEW OF THE REPACKAGING PROCESS, PACKAGING MATERIALS AND HANDLING PROCESSES.
PHYSICIAN INSERTED THE SHEATH/HEMOSTASIS VALVE SIDE PORT LEAVING THE DILATOR INSIDE. THE DILATOR CAME OUT OF SHEATH DURING THE NIGHT AND THE PT BLED TO DEATH. CO PRODUCT LABELING STATES THAT THE DILATOR SHOULD NOT BE LEFT IN PLACE INSIDE THE SHEATH DURING USE.
NURSES HAD TO USE MULTIPLE SETS WITH .22 MICRON FILTER IN AN ATTEMPT TO INFUSE HYPERALIMENTATION ON A PT WITH A PIC LINE ON. FOUR (4) SETS WERE USED BEFORE THE NURSE WAS ABLE TO INFUSE THE HYPERALIMENTATION. TWO (2) OF THE FAULTY SETS ARE AVAILABLE FOR INSPECTION. SUSPENSION OF STOCK NOT REQUIRED AT THIS TIME, SALES REP IS TO MEET WITH RPTR AND BELIEVES THE PROBLEM WITH THIS ITEM IS SETS COLLAPSED.
THE DEVICE WAS REMOVED DUE TO "INFECTION".
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 1/1994 AND REMOVED ON 8/15/96 DUE TO AN "INFECTION." REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. HOWEVER, BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QA INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
CASTER HINGE L RV, 5/16 X 5/8 LG SHOULDER BOLT. DEALER CLAIMS CASTER HINGE STRIPPED OUT AND BROKE.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
FOUND UNKNOWN DISCOLORATION IN STERILE WRAPPED GAUZE SERIOUSLY AFFECTING STERILITY OF ITEM.
THE PT BEGAN FEELING ILL WITH VOMITING ON 8/7. HER 8/A BLOOD GLUCOSE RESULT ON  HER METER WAS 194 MG/DL, IMMEDIATELY FOLLOWED WITH A 174 MG/DL RESULT. SHE WAS GIVEN HER MORNING INSULIN DOSE OF 57 ULTRALENTE AND 15U NPH. SHE CONTINUED VOMITING AND "COULDN'T KEEP ANYTHING DOWN." SHE WAS TAKEN TO THE DR AT APPROX 10 AM WHERE HER BLOOD GLUCOSE RESULT WAS 594 MG/DL (METHOD UNKNOWN). SHE WAS SUBSEQUENTLY SENT TO THE HOSP WHERE SHE WAS ADMITTED FOR DKA. HER ADMITTING BLOOD GLUCOSE WAS "500 SOMETHING" ON A HOSP METER. TREATMENT PROVIDED IS UNKNOWN. THE PT'S METER AND TEST STRIPS (FROM METER CASE) WERE COMPARED WITH THE HOSP'S METER WITH THE FOLLOWINTG RESULTS: PT'S METER 104 MG/DL, HOSP METER 309 MG/DL. THE METER IS NOT MAINTAINED ACCORDING TO MFR'S RECOMMENDATIONS. ALCOHOL AND CONTROL SOLUTION ARE USED TO CLEAN THE METER OPTICS. THE OWNER'S BOOKLET WARNS TO USE ONLY WATER ON THE METER OPTICS. IN ADDITION, THE TEST STRIPS ARE STORED OUTSIDE OF THE VIAL IN THE METER CASE. CALIBRATION TESTS ARE NOT PERFORMED.
CO HAS COMPLETED INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAS NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. REVIEW OF THE METER MEMORY INDICATES THAT QUALITY CONTROL TESTS ARE NOT PERFORMED (CHECKSTRIP AND CONTROL SOLUTION TESTS). CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNKNOWN ANOMALY. AT THIS POINT CO'S INVESTIGATION OF THIS MATTER IS CLOSED. BLOCK G4-INCORRECT DATE REPORTED ON INTIAL REPORT (8/2/96. CORRECT DATE IS 8/9/96.
THE PT HAD A 9FR. SHEATH IN PLACE WITH A SINGLE LUMEN INFUSION CATHETER (SLIC) THROUGH IT. THE PT WAS MOBILE AND BRUSHED THEIR HAND OVER THE AREA OF THE SHEATH AND STYLET. IN DOING SO CAUSED THE OBTURATOR PORTION TO COME OUT OF SLIC AND FALL ON THE FLOOR. THE PT RANG BELL TO ALERT PERSONNEL THAT HE WAS WEAK. THE PT SUFFERED AN AIR EMBOLUS BUT WAS TREATED WITH NO FURTHER COMPLICATIONS. INFO FROM THE USER INDICATED THAT THE OBTURATOR WASN'T TIGHTENED PROPERLY.
ON 11/26/95 AT APPROX 1600 HRS RPTR WAS NOTIFIED OF AN OVERHEAD EXAMINATION LIGHT THAT WAS SMOKING AND SHOOTING SPARKS. AFTER NECESSARY SAFETY MEASURES WERE TAKEN THE LIGHT ARM AND HEAD WERE DISASSEMBLED AND THE CAUSE WAS IDENTIFIED. AT THE LOWER SECTION OF THE ARM, THE HOT WIRE HAD BEEN STRETCHED TO THE POINT OF BREAKING. THIS EXPOSED THE 120 VAC LINE DIRECTLY TO THE METAL CASING CAUSING SPARKS AND A POTENTIALLY LIFE THREATENING SITUATION. THE UNIT WAS REMOVED FROM SVC. FOUR OTHER UNITS IN THE BUILDING HAVE HAD SIMILAR PROBLEMS WITH THE EXAM LIGHTS' INTENDED STOP MECHANISM NOT FUNCTIONING PROPERLY. THIS ALLOWS THE POWER CORD TO WRAP ITSELF AROUND THE BASE OF THE LIGHT, EVENTUALLY PULLING THE WIRES APART. ALL LIGHTS OF THIS MFR HAVE BEEN TAGGED AND SCHEDULED FOR REMOVAL AND REPLACEMENT. THE MFR SAID THEY HAVE MADE THIS SYSTEM ABOUT 17 YEARS AGO. THE COMPLAINANTS' LIGHT IS ABOUT 6 YEARS OLD. MFR REPORTED THAT THEY HAVE NO SIMILAR COMPLAINTS BUT ARE INVESTIGATING.
ARTICLE ALLEGED: COMPLAINT OF ABDOMINAL PAIN, NAUSEA. PANCREATITIS WERE EXPRESSED BY PT AFTER 4 HOURS OF DIALYSIS TREATMENT. ALTHOUGH NOT DIRECTLY  OBVSERVED, IT WAS SPECULATED THAT HEMOLYTIC REACTIONS WERE CAUSED BY KINKED BLOOD LINE. COMPLAINTS OF THIS NATURE WERE INVESTIGATED UNDER FIR $93015. PRODUCT UNDER SAME COMPLAINT.
THE FOLLOWING CONCLUSIONS WERE DRAWN: CRUSHED BOXES DUE TO STACKING BOXES HIGHER THAN THE CORRUGATED MATERIAL RATING ALLOWED. BOXES DID NOT FIT ("OVERLAPPED") THE SHIPPING PALLETS. PRODUCT PACKING DENSITY TOO HIGH LEADING TO KINKING AND DENTING OF LINES IN STERILIZATION AND STORAGE. HOWEVER IN A LABORATORY TESTING, VERY SEVERE KINKS INVOLVING >85% OCCLUSION OF THE BLOOD LINE HAVE BEEN SHOWN TO CAUSE HEMOLYSIS; LESS SEVERE KINKS DID NOT CAUSE HEMOLYSIS. IN ADDITION, KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYUSIS WOULD RENDER THE BLOOD LINE UNUSABLE BECAUSE THE LINE COULD NOT BE PRIMED; KINKS SEVERE ENOUGH TO POSSIBLY CAUSE HEMOLYSIS WOULD TRIGGER A SAFETY FEATURE OF THE HEMODIALYSIS MACHINE WHICH WOULD CAUSE THE MACHINE TO ALARM DUE TO OUT OF RANGE PRESSURE READING; AND IN TURN WOULD CAUSE THE BLOOD PUMP TO STOP. CO HAS A MAJOR REPACKAGING PROJECT IN PROGRESS. THIS PROJECT INCLUDES COMPLETE REVIEW OF THE REPACKAFGING PROCESS, PACKAGING MATERIALS AND HANDLING PROCESSES.
A PT PRESENTED AT OFFICE WITH RESTORATION AND ABUTMENT BROKEN. PT IS REPORTEDLY FINE.
NO OBERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER FROM YOUR OFFICE WAS UNAVAILABLE.
PT RECEIVED HER SECOND TREATMENT ON 5/20/96. ON 6/3/96, SHE RECEIVED REDNESS, SWELLING, RIDGES, KNOTS AND FIRMNESS AT ALL TREATMENT SITES. SHE WAS SEEN ON 6/7/96; THE INJECTING PHYSICIAN'S ASSOCIATE DIAGNOSED A HYPERSENSITIVITY AND PRESCRIBED ORAL ADVIL AND TOPICAL TEMOVATE CREAM. ON 6/10/96, THE SYMPTOMS PERSISTED; IBUPROFEN WAS PRESCRIBED. ON 7/8/96, THE SYMPTOMS PERSISTED; INTRALESIONAL KENALOG WAS PRESCRIBED WHICH WAS BARELY EFFECTIVE AT RELIEVING THE SYMPTOMS.
FOLLOW UP INFO WAS RECEIVED ON 23 SEPT 1997; THE PHYSICIAN RPT'D THAT THE SYMPTOMS RESOLVED AT THE END OF MAY 1997.
ELECTRODES WERE PUT ON CART ON 10/31/95. WHEN APPLIED TO PT THE EKG WAS UNREADABLE. OTHER ELECTRODES WERE APPLIED TO THE SAME PTS TO SEE IF IT WAS THE ELECTRODES OR THE EKG MACHINE. IT WAS PROVEN TO BE THE ELECTRODES.
THE STERILIZATION INDICATOR STRIPS (ETO) HAVE BEEN UNPREDICTABLE IN CHANGING COLOR WHEN EXPOSED TO ETHYLENE OXIDE. THIS HAS OCCURRED REPEATEDLY AND IN MULTIPLE LOTS. WHEN FOUR STRIPS WERE STERILIZED IN A SINGLE STERILIZATION CONTAINER, ALL FOUR SHOWED DIFFERENT COLOR CHANGES. ALL ETO STERILIZATION CRITERIA WAS MET AND ALL OTHER CHEMICAL AND BACTERIOLOGICAL INDICATORS ACCURATELY SHOWED THIS.
INITIAL BILATERAL IMPLANTATION AND ON 2/75. LAWSUIT FIELD ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FIELD IN CAUSE NO. 92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE, IN HARRIS COUNTY. TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
PT WAS SKIN TESTED ON 3/26/96 WITH NEGATIVE RESULTS AND RECEIVED HER FIRST TREATMENT ON 6/3/96 INTO THE NASOLABIAL FOLDS AND GLABELLA. ON 6/21/96, THE PT NOTED THAT THE RIGHT NASOLABIAL FOLD INTERMITTENTLY BECAME RED AND PALPABLE. SHE WAS SEEN LATER THAT DAY WITH NO VISIBLE SYMPTOMS AT THE NASOLABIAL FOLDS AND GLABELLA AND SLIGHT REDNESS AT THE TEST SITE. NO MEDICAL OR SURGICAL INTERVENTION WAS PRESCRIBED. ON 7/30/96, THE PT DEVELOPED REDNESS, SWELLING AND PAIN AT THE NASOLABIAL FOLDS AND GLABELLA. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY AND PRESCRIBED IBUPROFEN AND COOL COMPRESS. ON 7/31/96, THE PHYSICIAN NOTED ERYTHEMA AND SWELLING AT THE NASOLABIAL FOLDS AND GLABELLA. DIPROLENE OINTMENT WAS PRESCRIBED, WHICH WAS NOT EFFECTIVE. ON 8/5/96, THE SYMPTOMS PERSISTED; KENALOG WAS INJECTED INTRALESIONALLY WHICH HELPED THE ITCHING AND EDEMA. ON 8/5/96, THE SYMPTOMS PERSISTED; KENALOG WAS INJECTED INTRALESIONALLY.
THE PHYSICIAN REPORTED THAT SHE LAST SPOKE WITH THE PT IN 4/97. THE SYMPTOMS HAD SUBSIDED. THE DATE OF RESOLUTION WAS NOT SPECIFIED.
ON 8/7, THE PT BEGAN FEELING ILL WITH VOMITING, DIARRHEA, LACK OF ENERGY AND FAINTNESS. SHE HAD BEEN OBTAINING READINGS IN THE "30'S" ON HER METER FOR A WK. SHE REPORTED THAT SHE ATE HER USUAL MEALS, BUT DID NOT TAKE INSULIN FOR A WEEK. ON 8/10, SHE WAS TRANSPORTED TO THE HOSP BY A RELATIVE WHERE A BLOOD GLUCOSE RESULT OF "OVER 300" WAS OBTAINED (UNKNOWN METHOD). SHE WAS TREATED WITH INSULIN & RELEASED THE SAME DAY. THE METER IS CLEANED CORRECTLY, HOWEVER QUALITY CONTROL TESTS ARE NOT PERFORMED. ALSO, THE PT REMOVES THE TEST STRIPS FROM THEIR ORIGINAL CONTAINER AND STORES THEM IN AN OLDER CONTAINER. THE PACKAGE INSERT STATES TO STORE THE STRIPS IN THEIR ORGINAL VIAL WITH THE CAP TIGHTLY CLOSED AND NEVER TRANSFER TEST STRIPS TO A NEW VIAL OR ANY OTHER CONTAINER.
CO HAS COMPLETED CO'S INVESTIGATION OF THE MDR INCIDENT DOCUMENTED IN CO'S INITIAL REPORT AND, AFTER TESTING THE DEVICE, CO NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO THE USER ERROR, IMPROPER METER MAINTENANCE, INCORRECT STORAGE OF TEST STRIP PRODUCT, OR SOME UNK ANOMALY. AT THIS POINT CO INVESTIGATION OF THIS MATTTER IS CLOSED.
THE DOOR THRUST BEARING FAILED BECAUSE EXCESSIVE FORCE WAS APPLIED DURING PERVIOUS OPERATION OF CLOSING THE CHAMBER DOOR. THIS CAUSES A THRUST BALL BEARING TO FAIL. THE MFR'S INVESTIGATION REPORT FURTHER INDICATES THAT IF THE FACTORY INSTRUCTIONS FOR CLOSING THE DOOR ARE FOLLOWED, THERE WILL BE NO PROBLEM. THE MFR'S INVESTIGATION REPORT STATES "DESPITE THE FACT THAT NO ACTUAL DANGER EXISTS AS THE DOOR WILL ONLY OPEN 3 MM (1/8") AS THE RESULT OF A BROKEN BEARING. A NOISE WILL BE HEARD WHEN THE BEARING BURST AND THE DOOR HANDLE MECHANISM WILL REQUIRE REPLACEMENT, BUT NO OTHER DAMAGE WILL OCCUR." THE MFR STATES THAT THEY HAVE THOUSANDS OF THESE UNITS OPERATING WORLDWIDE AND ONLY 3 COMPLAINTS. THE MFR HAS REPLACED THE BALL BEARING WITH A SOLID MATERIAL THRUST BEARING ON ALL STERILIZERS SHIPPED SINCE 12/18/94. THEY WILL NOT EFFECT A BLANKET RECALL OF ALL MODEL SERIES 2540 UTILIZING THE BALL BEARING. THE MFR HAS SHIPPED 6 NEW REPLACEMENT DOOR CLOSURE DEVICES TO THE COMPLAINANT. THE FINAL SUMMARY OF THE FACTORY INVESTIGATION STATES "THE BEARINGS ON CUSTOMER UNITS WILL BE REPLACED AS PER DEALER DISCRETION." MFR HAS REDESIGNED THE BEARING. USERS OF THIS MODEL THAT EXPERIENCE A DOOR BEARING PROBLEM SHOULD SEND A REPORTING AND PROCESSING MEDICAL MATERIAL COMPLAINTS/QUALITY IMPROVEMENT REPORT, FORM 380, REFERENCING THIS PROJECT. THIS PROJECT IS CLOSED PENDING NEW COMPLAINTS OF THE SAME NATURE. CURRENT COMPLAINANT RECEIVED NEW REPLACEMENT PARTS. POSSIBLE FUTURE COMPLAINANTS WILL BE HANDLED ON A CASE BY CASE BASIS.
INITIAL IMPLANTATION OF THE LEFT IMPLANT WAS ON 1/16/80. LAWSUIT FILED ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO. 92-16550, I RE: MASTER SILICONE BREAST IMPLANT FILE, IN HARRIS COUNTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE  SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
PLAINTIFF ADOPTS MASTER PETION FIELD IN CAUSE NO. 92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE, IN HARRIS COUNTY. TX MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
THE DEVICE WAS REMOVED DUE TO A "LEAK". THE ENTIRE DEVICE WAS REMOVED AND REPLACED.
IN THE RECEIVED INFO THE PHYSICIAN STATED THAT A "TUBING RUPTURE" HAD LEAD TO THE "LOSS OF FLUID." THE PHYSICIAN FURTHER STATED THAT THE RUPTURE HAD OCCURRED "AT JUNCTION OF TUBING (AND) RESIPUMP." THE PHYSICIAN NOTED THERE WERE NO APPARENT CONTRIBUTING FACTORS TO THIS OCCURRENCE WITH THE POSITIONING OF THE DEVICE OR THE PT'S HISTORY. EXAMINATION AND TESTING OF THE DEVICE REVEALED A COMPLETE SEPARATION OF THE EXITING TUBE BETWEEN OUTLET #1 AND CYLINDER #1 AT THE PUMP STRAIN RELIEF/TUBE JUNCTION. EXAMINATION OF THE SURFACE OF THE SEPARATION, BOTH ON THE PUMP AND CYLINDER SIDE, REVEALS MARKINGS INDICATING STRESS(S) INDUCED RENTING AND CONTACT WITH SHARP INSTRUMENTATION. ANTERIORLY LOCATED, A CONFINED AREA OF ABRASION IS NOTED ON THE PUMP STRAIN RELIEF AND EXITING TUBE. WITHIN THIS AREA OF ABRASION A CREASE MARK IS NOTED. FURTHER EXAMINATION REVEALED THAT THE MONOFILAMENT WAS RETRACTED FROM ITS ORIGINAL POSITION BOTH IN THE PUMP AND CYLINDER. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE COMPONENTS DURING TESTING. ALTHOUGH THE PHYSICIAN STATED THAT THE DEVICE HAD NOT BEEN IN CONTACT WITH SHARP INSTRUMENTATION, BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT THE OBSERVED MARKINGS INDICATING CONTACT WITH SHARP INSTRUMENTATION OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. IN ADDITION, BECAUSE THE EXPECTED USE OF THIS DEVICE COMBINED WITH THE LOCATION OF THIS OBSERVED DAMAGE WOULD HAVE RESULTED IN AN EARLIER DETECTED FLUID LOSS, QA CONCLUDED THAT THIS DAMAGE MOST LIKELY OCCURRED AT OR SUBSEQUENT TO EXPLANT. BASED ON QA'S EXAMINATION AND THE PHYSICIAN'S OBSERVATIONS, QA CONCLUDED THAT WHILE IN-VIVO OUTLET #1'S EXITING TUBE WAS PARTIALLY KINKED AND ABRADING AGAINST ITSELF AND ITS STRAIN RELIEF. QA FURTHER CONCLUDED THAT THIS POSITIONING COMBINED WITH THE OVER EXTENDING OF THE EXITING TUBE DURING USE, OVERTIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBE AT THIS SITE. THIS RENT WOULD HAVE THEN ALLOWED THE LOSS OF FLUID OR "LEAK." REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
PT RECEIVED HER FIRST TREATMENT INTO THE LEFT NASOLABIAL FOLD AFTER 1988. THREE TO FOUR WEEKS AFTER THE TREATMENT, THE PT DEVELOPED SEVERE REDNESS AND SWELLING AT THE LEFT NASOLABIAL FOLD WHICH WAS DIAGNOSED AS A HYPERSENSITIVITY. THE EXACT DATES OF TREATMENT AND ONSET OF SYMPTOMS WERE UNKNOWN. IBUPROFEN WAS PRESCRIBED FOR THE FIRST MONTH THE SYMPTOMS WERE PRESENT, AND IT SOMETIMES HELPED RELIEVE THE SYMPTOMS. THIS PERSISTED FOR APPROX ONE YEAR, AND RESOLVED IN APPROX 1991, EXACT DATE UNKNOWN. WHEN THE SYMPTOMS RESOLVED, THE LEFT NASOLABIAL FOLD HAD A SUBTLE DUPLICATE NASOLABIAL FOLD WHICH THE PHYSICIAN BELIEVED WAS DUE TO THE INTENSITY OF THE INFLAMMATION FROM THE HYPERSENSITIVITY.
THE DEVICE WAS REMOVED DUE TO A "LEAK AT THE CONNECTOR(S)".
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 10/7/86 AND REVISED ON 8/15/96 BECAUSE IT "LEAKED AT CONNECTORS." IN THE RECEIVED INFORMATION THE PHYSICIAN STATED THAT LEAKAGE WAS NOTED IN THE "R CYLINDER EXIT TUBING." THE PHYSICIAN FURTHER STATED THAT THE TUBING WAS NOT KINKED OR TWISTED, THAT THE TUBING LENGTHS WERE NEITHER EXCESSIVE NOR INADEQUATE AND THAT ALSO THE DEVICE WAS NOT IN A POSITION THAT WOULD HAVE CAUSE STRESS(S). THE PHYSICIAN ALSO STATED THAT THERE WAS NO INFORMATION APPARENT IN THE PT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE AND THAT THE DEVICE WAS NOT IN CONTACT WITH SHARP INSTRUMENTATION DURING THE EXPLANT PROCEDURE. QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PROCLUDED FROM COMMENTING ON THE CONDITION OF THE PROTHESIS. SHOULD THE EXPLANTED DEVICE BECOME AVAILABLE, OR ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAIANT IN ACCORDANCE TO PROCEDURES.
SEVERE MITRAL REGURGITATION AND SEVERE PULMONARY HYPERTENSION.
INITIAL IMPLANTATION OF THE RIGHT IMPLANT 1/16/80. LAWSUIT FIELD ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO.92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE, IN HARRIS COUNTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
ACCORDING TO A PHYSICIAN'S REPORT, THE VALVE WAS REPLACED ON 10/28/94 FOLLOWING AN ENDOCARDIOGRAPHIC EVALUATION INDICATING THROMBUS WAS PRESENT. WHEN THE AORTA WAS OPENED IT WAS FOUND THAT THERE WAS LITTLE THROMBUS PRESENT ALONG THE SEAT OF THE VALVE, AND DID NOT OBSTRUCT THE FUNCTION OF THE VALVE. POST OPERATIVE IT APPEARED THAT THE PT HAD HAD AN EXTENSION OF HIS STROKE. HE WAS DISCHARGED FROM THE HOSP ON 11/14/94.
THE VALVE WAS EXAMINED WITH A LIGHT MICROSCOPE AT 20X MAGNIFICATION. THE OUTLET STRUT LEGS WERE FOUND TO BE INTACT. WEAR PATTERNS TYPICAL FOR VALVES IMPLANTED FOR NINE YEARS WERE OBSERVED ON THE OUTLET STRUT, INLET STRUT, FLANGE INNER DIAMETER, AND DISC. SCRATCHES AND TOOLMARKS WERE NOTED, WHICH COULD HAVE OCCURRED DURING EITHER IMPLANT OR EXPLANT PROCEDURES. THROMBOSIS IS A KNOWN LONG TERM POTENTIAL COMPLICATION OF MECHANICAL HEART VALVE IMPLANTATION.
THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION".
ACCORDING TO THE AVAILABLE INFO THIS DEVICE WAS IMPLANTED ON 5/24/89 AND REMOVED ON 7/24/96 DUE TO A "MALFUNCTION." REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A COMPLETE SEPARATION OF OUTLET #2'S EXITING TUBE AT THE RESIPUMP STRAIN RELIEF/TUBE JUNCTION. THE OBVIOUS SEPARATION OF COMPONENTS AT THIS SITE WOULD HAVE ALLOWED LEAKAGE. EXAMINATION OF THE SURFACES OF THE SEPARATION, BOTH ON THE OUTLET AND CYLINDER SIDE, REVEALED MARKINGS CHARACTERISTICS OF STRESS(S) INDUCED RENDING. AREAS OF ABRASION ARE NOTED AROUND EACH TUBE END. A CREASE MARK IS NOTED WITHIN THE ABRASION ON THE OUTLET SIDE. THE MONOFILAMENT IS EXTRACTED FROM THE OUTLET CAVITY AND IS PROTRUDING FROM THE DISTAL TUBE END OF CYLINDER #2. BASED ON QA'S EXAMINATION AND THE LIMITED INFO PROVIDED, QA CONCLUDED THAT WHILE IN-VIVO, OUTLET #2'S EXITING TUBE WAS PARTIALLY KINKED AND ABRADING AGAINST ITSELF AND ITS ASSOCIATED STRAIN RELIEF..QA FURTHER CONCLUDED THAT THIS POSITIONING, COMBINED WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBING AT THIS SITE, ALLOWING THE LOSS OF FLUID AND RENDERING THE DEVICE INOPERABLE.
INITIAL IMPLANTATION OF THE LEFT IMPLANT WAS ON 3/2/84. LAWSUIT FILED ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO. 92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE. HARRIS COUNTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
THE DEVICE WAS IMPLANTED ON 5/24/95, FOR INFUSION OF FUDR THROUGH THE SUBCLAVIAN VEINS (NOTE: INFUSION OF FUDR THRU SUBCLAVIAN VEIN IS NOT AN INDICATION FOR THE MFR'S INTENDED USE). ON 8/13/96, THE FACILITY'S PHARMD CONTACTED A MFR CLINICAL SPECIALIST WITH CONCERNS ABOUT ACCURATE DRUG DOSING VIA THE DEVICE DUE TO FLOW RATE VARIATIONS OF THIS DEVICE. THE FACILITY'S PHARMD STATED THAT FOLLOWING FLOW RATE (FR) INFO: 6/19/96, FR=1.53ML/DAY, 7/29/96, 1.93 ML/DAY AND ON 8/12/96, FR=1.14 ML/DAY. THE HEPARIN CONCENTRATION =80,000U/50ML. THE FACILITY'S PHARMD ALSO STATED THAT THE REFILL PERSON USED THE MFR'S 22GA NEEDLE, BUT NOT THE MFR'S REFILL KIT; HOWEVER, THE REFILL PERSON AND THE EQUIPMENT ARE CONSISTENT. THE DEVICE SIDEPORT WAS CHECKED FOR PATENCY WITH A HEPARIN/NORMAL SALINE FLUSH AND NO RESISTANCE WAS MET DURING INJECTION. THE DEVICE SIDEPORT HAD NOT BEEN PREVIOUSLY ACCESSED. NO DYE STUDY TO CHECK CATHETER PATENCY HAD BEEN PERFORMED SINCE THE DEVICE WAS IMPLANTED. THE MFR'S CLINICAL SPECIALIST RECOMMENDED A DYE STUDY THROUGH THE DEVICE SIDEPORT TO RULE OUT DEVICE CATHETER MIGRATION AND CONSIDER USE OF A THROMBOLYTIC IN THE DEVICE SIDEPORT. THE PHARMD STATED THAT THERE WAS NO AIR IN THE DEVICE RESERVOIR OR CHANGES IN THE PT'S ACTIVITIES OR ELEVATION. THE PT IS DOING WELL ON THE MEDICATION/TREATMENT, AND TREATMENT WOULD CONTINUE.
ON 9/4/96, THE FACILITY'S PHARMD CONTACTED A MFR SALES REPRESENTATIVE AND INFORMED HER THAT THE PT'S DEVICE WAS FILLED (9/4/96), AND THE FLOW RATE OF THE DEVICE =1.8ML/DAY (80,000U/50ML HEPARIN), RATHER THAN THE MFR'S PREDICTED FLOW RATE OF 2.23ML/DAY (50,000U/50ML HEPARIN). ADDITIONALLY, SHE STATED THAT A DYE STUDY WAS PERFORMED PER THE MFR'S CLINICAL SPECIALIST RECOMMENDATIONS WHICH DEMOSTRATED THAT THERE WERE NO IRREGULARITIES WITH THE DEVICE CATHETER. THE FACILITY'S PHARMD AGREED TO CALCULATE THE PT'S DOSAGE ON THE NEW FLOW RATE OF THE DEVICE AND THE DOSAGE WILL BE ADJUSTED BASED ON THE CURRENT FLOW RATE OF THE DEVICE. THE DEVICE REMAINS IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES FOR THIS DEVICE RELATED TO THIS EVENT. BASED ON THE INFO AVAILABLE, THE CAUSE OF THE DEVICE SLOW FLOW RATE COULD NOT BE DETERMINED; THEREFORE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. ALTHOUGH NOT PART OF THE MFR'S OIRIGINAL OCTOBER 1992 DEVICE SAFETY ALERT, INSTRUCTIONS PROVIDED IN THE ALERT GUIDELINES APPLY TO THIS DEVICE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THE MFR IS NOW CLOSING THE FILE IN THIS EVENT.
A CORONARY STENT WITH DELIVERY SYSTEM WAS ADVANCED TOWARD THE TARGET LESION SITE IN THE LEFT ANTERIOR DESCENDING ARTERY. AT A POINT PROXIMAL TO THE TARGET LESION SITE, THE STENT EMBOLIZED. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION. A SNARE DEVICE WAS UTILIZED TO RETRIEVE THE STENT TO THE VASCULAR ACCESS SITE WHERE IT EMBOLIZED INTO THE PERIPHERAL VASCULATURE. ANOTHER STENT WAS SUCCESSFULLY PLACED AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
MILD STENOSIS AND ONE SMALL HOLE IN LEAFLET.
THE DEVICE WAS REMOVED DUE TO A "FLUID LOSS", SECONDARY TO A TUBING BREAK".
EVAL IS PENDING DECONTAMINATION, EXAMINATION AND TESTING OF THE RETURNED DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT AND SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION.
BALLOON WAS PLACED IN TARGET LESION AT THE MID RIGHT CORONARY ARTERY, INFLATED, AND DEFLATED. UPON 2ND INFLATION AT 12 ATM, THE BALLOON BURST WITH A JETSTREAM LEAK AND RESULTED IN A DISSECTION OF THE ARTERY. THE INSTRUCTIONS FOR USE STATE THE BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE OF 8 ATM. THE VESSEL WAS SUCCESSFULLY REPAIRED BY TACKING THE DISSECTION WITH 3 1/2 STENTS (2 FULL 2ND AND 3RD CO STENTS, 1 FULL STENT AND 1/2 OF A 2ND CO'S STENT THAT HAD BEEN CUT IN 2). THE PROCEDURE WAS FINISHED WITH NO FURTHER PT COMPLICATIONS.
ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED BY THE RPTR. DESPITE ATTEMPTS TO OBTAIN SUCH INFO FROM THE RPTR, CO IS UNABLE TO PROVIDE COMPLETE INFO REQUIRED IN FORM 3500A. RETURNED CATH WAS REPORTEDLY INFLATED TWICED & DURING 2ND INFLATION AT 12 ATM, A LEAK WAS NOTED BY DR. RATED BURST PRESSURE FOR THIS UNIT IS LABELED AS 8 ATM. DURING ANALYSIS, BALLOON ON CATHETER WAS PRESSURIZED AND A VERY SMALL ANGULAR TEAR RESULTING IN A JETSTREAM LEAK WAS FOUND NEAR THE MARKER BAND. SCANNING ELECTRON MICROSCOPE INSPECTION REVEALED SIGNS OF SCORING ON EACH SIDE OF BALLOON, CHATTERMARKS OPPOSITE THE TEAR. NO OTHER DAMAGE OR FUNCTIONAL PROBLEMS WERE FOUND, HEOWEVER, TRACES OF CALCIUM WERE IDENTIFIED AT THE TEAR SITE DURING SUBSEQUENT ELEMENT ANALYSIS OF THE DAMAGED SITE. THE CATHETER WAS TAKEN ABOVE THE RECOMMENDED ATM ON ITS 2ND INFLATION WHEN THE LEAK WAS NOTED. PAST HISTORY OF BALLOON BURSTS INDICATES A LONGITUDINAL TEAR IS THE NORMAL FAILURE MODE WHEN A BALOOON WITH NO SURFACE DAMAGE IS TAKEN ABOVE ITS RATED ATM. THIS FAILURE MODE TYPICALLY DOES NOT CAUSE VESSEL INJURY. HOWEVER, IF THE BALLOON SURFACE IS DAMAGED, OVERPRESSURIZING THE UNIT CAN CAUSE THE WEAKENED AREA TO BURST IN A NON-LINEAR FASHION, SUCH AS A SMALL TEAR. NO CORRECT ACTION WAS TAKEN DUE TO THE FOLLOWING REASON: NO MFG DEFECTS WERE FOUND; LOSS OF PRESSURE DUE TO CALCIFICATION DAMAGE (SUCH AS PERFORATIONS AND SCORING) IS A KNOWN FAILURE MODE FOR BALLOONS USED IN CALCIFIED LESIONS; VESSEL DISSECTIONS ARE LISTED IN THE EVERGREEN CATHETER "INSTRUCTIONS FOR USE" AS A POSSIBLE ADVERSE EFFECT DURING PTCA PROCEDURES; AND A WARNING STATEMENT INSTRUCTING USERS NOT TO TAKE THE CATHETER ABOVE THE BURST PRESSURE IS ALSO INCLUDED IN THE INSTRUCITONS. THE DEVICE IN QUESTION MOST LIKELY WAS EXPOSED TO LESIONS WITH CALCIFICATION, AND OVERPRESSURIZING IT CAUSED A NON-LINEAR TEAR AT THE DAMAGED SITE. ALTHOUGH NO CORRECTIVE ACTION WAS INITIATED AT THE MFG FACILITY, A LETTER REFERENCING THE BURST PRESSURE AND A DESCRIPTION OF THE DAMAGE WAS SENT TO THE DR FOR HIS INFO.
INITIAL IMPLANTATION OF THE RIGHT IMPLANT 3/2/84. LAWSUIT FILED ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO.92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE, HARRIS COUNTY. TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLF THIS PRODUCT SINCE 1984.
AN ABUTMENT BROKE IN FUNCTION. THE DR SEEMS TO THINK IT IS DUE TO THE FORCES FROM SCUBA DIVING. PT IS SAME PT AS MEDWATCH REPORT 2023141-1996-023.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. ACCURATE MEASUREMENTS COULD NOT BE TAKEN DUE TO THE DAMAGED CONDITION OF THE PRODUCT. CO IS UNABLE TO REVIEW THE PRODUCT'S LOT HISTORY SINCE THE LOT NUMBER WAS UNAVAILABLE FROM OFFICE.
AN ABUTMENT BROKE IN FUNCTION. THE DR SEEMS TO THINK IT IS DUE TO FORCES FROM SCUBA DIVING. PT IS SAME PT AS MEDWATCH REPORT. #2023141-1996-00022.
METHOD (86) PART WAS NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DR. DURING INSPECTION OF RETURNED PARTS I: WAS DISCOVERED THAT THIS PART WAS NOT RETURNED FOR EVALUATION.
INITIAL BILATERAL IMPLANTATION WAS ON 2/23/87. LAWSUIT FILED ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO. 92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE, HARRIS COUNTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
THE DEVICE WAS REMOVED DUE TO "A MINIMAL INFECTION IN THE SCROTUM". ADDITIONALLY, IT WAS REPORTED THAT THE "PT EXPERIENCED PAIN AROUND THE AREA OF THE PUMP COMPONENT". "THE DEVICE WAS REMOVD ENTIRELY, ANTIBIOTIC SOLUTION WAS USED TO FLUSH SEVERAL TIMES, AND A NEW DEVICE WAS PUT IN PLACE".
IN THE REC'D INFO, THE DR STATED THAT THE CULTURE RESULTS SHOWED THE PRESENCE OF "RARE STAPH SPECIES." THE DR ALSO STATED THAT THE PT WAS OBESE, DIABETIC, AND THAT DIFFICULTY WAS EXPERIENCED DURING IMPLANTATION DUE TO THE PT'S "VERY LONG AND DEEP CORPORA," AND THAT THESE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DR FURTHER STATED THAT PT WAS EXPERIENCING A PROBLEM WITH AUTOINFLATION. EXAM AND TESTING OF THE DEVICE REVEALED TWO SITES OF LEAKAGE. THE FIRST IS A SEPARATION IN THE PROXIMAL PORTION OF CYLINDER
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR.
INITIAL BILATERAL IMPLANTATION WAS ON 5/17/83. LAWSUIT FILED ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO. 92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE, HARRIS COUNTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
METHOD (86): PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM LAB TECH.
AN IMPLANT DIDN'T INTEGRATE BECAUSE THE MAXILLA WAS SOFT AND SPONGY. PT IS REPORTEDLY FINE.
INITIAL BILATERAL IMPLANTATION 6/2/81. LAWSUIT FILED ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FIELD IN CAUSE NO. 92-16550; IN RE: IN RE: MASTER SILICONE BREAST IMPLANT FILE, HARRIS COUNTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
ALLEGED SYMPTOMS OF AUTOIMMUNE DISEASE AND VARIED INJURIES. FOLLOW-UP FINDINGS: UNSUBSTANTIATED BY A HLTH PROFESSIONAL. OUTCOME: UNDETERMINED.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PAT 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MED THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR IT'S EMPLOYEES, OR THE DR/USER CAUSE OR CONTRUBUTED TO THE REPORTABLE EVENT.
AN ABUTMENT BROKE WHILE PT WAS EATING BEEF JERKY. PT IS REPORTEDLY FINE.
METHOD (86): PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DR.
INSUFFICIENCY, PULMONARY DISEASE, AND HYPOTHYROIDISM.
INITIAL BILATERAL IMPLANTATION WAS ON 5/29/84. LAWSUIT FILED ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO. 92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE, HARRIS COUNTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT, CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
TWO ABUTMENTS BROKE (#19 AND #21). PT WAS CHEWING A STEAK AND THAT IS WHEN HE FELT IT BREAK. PT IS REPORTEDLY FINE.
METHOD (86): PART NOT RETURNED. LOT HISTORY CHECKED AND FOUND TO BE ACCEPTABLE.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MED THAT THE REPORT OF INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE DR/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
AN ABUTMENT BROKE IN FUNCTION. PT IS SAME PT AS PRIOR MDR REPORT #M751992.
PANNUS, REGURGITATION, "DETERIORATION", FATIGUE AND DYSPNEA.
H3: EXAMINATION OF THE VALVE IN CO LABORATORY REVEALED EXTENSIVE CALCIFICATION THROUGHOUT EACH CUSP WHICH RESULTED IN MULTIPLE DISRUPTIONS, INCLUDING DETACHMENT OF EACH LEAFLET, INCOMPLETE COAPTATION AND STENOSIS OF THE EFFECTIVE ORIFICE AREA HOST TISSUE OVERGROWTH FUSED EACH ATTACHMENT  SITE, CONTRIBUTING TO STENOSIS OF THE VALVE. X-RAY ANALYSIS REVEALED CALCIFICATION WITHIN THE AORTIC WALL, BELLY AND FREE MARGIN OF EACH CUSPO. ADDITIONALLY, SUGHT DISTORTION OF THE STENT WAS NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO EXCESSIVE CALCIFICATION. THESE FINDINGS WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY. H6: 86- X-RAY ANALYSIS.
IN THE RECEIVED INFORMATION THE PHYSICIAN STATED THAT  "POST-OPERATIVELY, THE PATIENT DEVELOPED PENILE SWELLING AND ARTHEMA, SCROTUM WITH SIGNIFICANT SUBCUTANEOUS INDURATION AND A CONSIDERABLE AMOUNT OF TENDERNESS AROUND THE PUMP." THE PHYSICIAN ALSO STATED THAT THE "SKIN OF THE SHAFT OF THE PENIS WAS RED AND EDEMATOUS, SCROTAL SKIN WAS RED BUT PRESENCE OF RUGAE." THE PHYSICIAN FURTHER STATED THAT ON 8/8 THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS TREATED WITH ANTIBIOTICS AND WHIRLPOOL THERAPY. THE PHYSICIAN STATED THAT THE PATIENT WAS OBSERVED, MAKING TREATMENT AND SUBSEQUENT REMOVAL OF THE DEVICE ON 10/14/96, DIFFICULT. THE PATIENT IS ALSO DIABETIC. AT THE TIME OF THE EXPLANT PROCEDURE THE PHYSICIAN STATED THAT "THERE WAS PURULENCE SURROUNDING THE PUMP AND PURITENCE COMMING FROM THE LEFT CYLINDER ALONG THE TUBING," AND THAT THERE WAS "NECROTIC CORPOREAL TISSUE" PRESENT. ENTEROCOCCUS ORGANISMS WERE FOUND IN THE CULTURES TAKEN FROM THE WOUND. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE REPORT OF INFECTION AS THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
THE DEVICE WAS REMOVED DUE TO AN "INFECTION". THE ENTIRE DEVICE WAS REMOVED. THE PHYSICIAN'S OPERATIVE NOTES STATE, "POST-OPERATIVELY, THE PATIENT DEVELOPED PENILE SWELLING AND ERYTHEMA, SCROTUM WITH SIGNIFICANT SUBCUTANEOUS INDURATION AND A CONSIDERABLE AMOUNT OF TENDERNESS AROUND THE PUMP. SKIN OF THE SHAFT OF THE PENIS WAS RED AND EDEMATOUS, SCROTAL SKIN WAS RED BUT PRESENCE OF RUGAE". DURING THE COURSE OF THE PROCEDURE TO REMOVE THE DEVICE IT WAS STATED,... "THERE WAS PURULENCE SURROUNDING THE PUMP AND PURULENCE COMING FROM THE LEFT CYLINDER ALONG THE TUBING". ..."NECTROTIC CORPOREAL TISSUE" WAS ALSO DISCOVERED. IT WAS ALSO CITED IN THE OPERATIVE NOTES THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL APPROXIMATELY TWO MONTHS POST-OPERATIVELY (NO SPECIFIC DATE WAS PROVIDED) AND..." PLACED ON INTRAVENOUS VENCOMY CIN AND PRIMAXIN. HE WAS ALSO BEGUN ON WHIRLPOOL THERAPY. PAIN, ERYTHEMA AND TENDERNESS GRADUALLY IMPROVED OVER THE COURSE OF HIS HOSPITALIZATION AND THERAPY. HE WAS DISCHARGED TO HOME MARKEDLY IMPROVED".
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO IS UNABLE TO REVIEW THE PRODUCT'S LOT HISTORY SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR'S OFFICE.
H3: EVAL OF THE VALVE IN MFR'S LAB REVEALED CALCIFICATION WITHIN EACH CUSP WHICH RESULTED IN STENOSIS OF EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS INCLUDING DETATCHMENT OF LEFT CORONOARY CUSP, AS WELL AS INCOMPLETE COAPTATION. DELAMINATED CIRCULAR & V-SHAPED DISRUPTIONS WERE NOTED IN EACH CUSP. ONE OF THESE DISRUPTIONS ALIGNED WITH A SUTURE TAIL ON SEWING RING WHEN LEAFLET WAS FLEXED OPEN. REMANANT SUTURE DISPLAYED SEVERAL KNOTS WHICH RESULTED IN AN ELONGATED PROJECTION ALLOWING FOR CONTACT WITH TISSUE. SUTURE MATERIALS REMOVED FROM SEWING RING IN AREA OF OUTER DISRUPTIONS PRIOR TO MFR'S RECEIPT. THEREFORE, THESE DISRUPTIONS WERE DUE TO AN INDETERMINABLE SOURCE. HOST TISSUE OVERGROWTH APPEARED TO HAVE BEEN REMOVED PRIOR TO RECEIPT  AS EVIDENCED BY DISRUPTED TRANSLUCENT HINGE AREA OF EACH CUSP, WHICH HAVE CONTRIBUTED TO STENOSIS OF VALVE. X-RAY ANALYSIS REVEALED CALCIFICATION WITHIN AORTIC WALL, BELLY AND FREEMARGIN OF EACH CUSP. SLIGNT STENT DISTORTION WAS ALSO NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO CALCIFICATION. H6: 86=X RAY.
DR ORIGINALLY REPORTED PN 0620 LOT NUMBER UNK, HOWEVER HE RETURNED PN 0621. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER FROM YOUR OFFICE WAS UNAVAILABLE.
F6. UNK; F7. UNK; F8. UNK; F11. UNK; F10. DEVICE CODE: 1077. H3: EVALUATION OF THE VALVE IN CO'S LABORATORY REVEALED CALCIFICATION WITHIN EACH CUSP WITH A LARGE CALCIFIC CLUSTER NOTED AT THE ATTACHMENT SITE BETWEEN THE RIGHT AND NONCORONARY CUSPS WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS, INCLUDING DETACHMENT OF THE NONCORONARY CUSP, AS WELL AS INCOMPLETE COAPTATION. HOST TISSUE OVERGROWTH ENCROACHED ONTO EACH CUSP, CONTRIBUTING TO STENOSIS OF THE VALVE. MECHANICAL DISRUPTIONS WERE NOTED IN EACH CUSP WHICH APPEARED ARTIFACTUAL OF EXPLANT. X-RAY ANALYSIS REVEALED CALCIFICATION WITHIN THE AORTIC WALL AND BELLY OF EACH CUSP. ADDITIONALLY CALCIFICATION WAS NOTED IN THE FREE MARGINS OF THE  RIGHT AND NONCORONARY CUSPS. STENT DISTORTION WAS NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO CALCIFICATION. THESE FINDINGS WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY. H6: X-RAY ANALYSIS = 86.
INITIAL BILATERAL IMPLANTATION WAS ON 1/8/80 WITH EXPLANT 10/8/84. LAWSUIT FILED ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO.92-16550; IN RE: MASTER SILICONE BREAST IMPLANT FILE, HARRIS COUNTY, TX, MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
AN ABUTMENT BRROKE IN FUNCTION. TWO UNIT CANTILEVERED BRIDGE #19-20 (#19 IMPLANT). PT IS REPORTEDLY FINE.
METHOD (86): PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DENTAL OFFICE.
THE PT'S DEVICE IS "ANGLEING WHEN PUMPED UP". IT WAS STATED THERE WAS A POSSIBLITY THE PROTHESIS WAS SHORT A REAR-TIP EXTENDER ON ONE SIDE".
NO SERIOUS MEDICAL OR SURGICAL INTERVENTION HAS OCCURRED AS OF THE DATE OF THIS REPORT. A REQUEST IS BEING MADE TO THE PHYSICIAN'S OFFICE FOR ADDITIONAL INFORMATION AND THE RETURN OF THE DEVICE/DEVICE COMPONENT(S) SHOULD SURGICAL INTERVENTION OCCUR. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELIING OR USUAL FOR SERVICE. AN EVALUATION WILL BE FORWARDED UPON COMPLETION.
THE DEVICE WAS IMPLANTED WITHIN THE RIGHT SUBCLAVIAN, ON 5/10/96, FOR US IN THE PT'S CHEMOTHERAPY TREATMENTS. ON 8/13/96, THE FACILITY OR NURSE CONTACTED THE MFR AND REPORTED THAT THE DEVICE WAS EXPLANTED ON 8/13/96, DUE TO A SPLIT IN THE DEVICE CATHETER. FURTHER COMM WITH THE FACILITY OR NURSE, ON 8/19/96, REVEALED THAT THIS INCIDENT WAS A "STRANGE SITUATION WHERE THE PT HAS RECENTLY RECEIVED HER 3RD IMPLANTED DEVICE." SEE MFR, REPORT 1219454-1996-00409 FOR ADD'L INFO REGARDING THE PT'S FIRST DEVICE. NO FUTHER INFO IS AVAILABLE REGARDING THIS INCIDENT. THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: RECEIVED IS A SINGLE LUMEN DELRIN DEVICE WITH AN ATTACHABLE 7 1/4" SEGMENT OF POLYURETHANE CATHETER AND A BAYONET LOCK. ALSO RECEIVED IS AN EXPLANT RECORD WHICH STATES THAT THE DEVICE WAS EXPLANTED AS A RESULT OF "LEAKING WHEN MEDICATION INJECTED." THE DEVICE BODY INCLUDING THE SEPTUM SHOWED NO ANOMALIES OR INTERNAL DAMAGE. THE DEVICE CATHETER SHOWED EVIDENCE OF PINCH-OFF SYNDROME ASSOCIATED WITH PROLONGED COMPRESSION APPROX 1 1/2" FROM THE BAYONET LOCK. THE DAMAGED AREA APPEARED COMPRESSED, DISCOLORED AND LONGITUDINALLY SLIT. THIS DEVICE WAS PATENT AND LEAKTIGHT AFTER ISOLATING THE DAMAGED AREA OF THE DEVICE CATHETER. NO OTHER ANOMALIES FOUND. AS PART OF CO'S INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CAT AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. IN CONCLUSION, THE REPORT OF A "CRACK" AND "LEAKAGE" WERE CONFIRMED BASED ON THE EVIDENCE OF LONGITUDINAL SLITS IN THE DEVICE CATHETER. BASED ON THE INFO AVAILABLE, AND THE DEVICE ANALYSIS, THE MFR BELIEVES THIS EVENT IS ATTRIBUTABLE TO DEVICE CATHETER PLACEMENT AND NOT TO THE DEVICE. THE DEVICE LABELING CONTAINS WARNINGS ON DEVICE CATHETER PLACEMENT. AN ARTICLE WILL BE FORWARDED TO THE FACILITY IDENTIFYING PINCH-OFF SYNDROME AS A POSSIBLE CAUSE OF FAILURE IN AN EFFORT TO PREVENT RECURRENCE OF THIS EVENT IN THE FUTURE. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
A PT WAS BEING TRANSPORTED WITHIN HOSP WHEN SHE BECAME CYANOTIC AND UNRESPONSIVE WHILE USING A OXYGEN SYSTEM. SHE WAS SWITCHED TO ANOTHER OXYGEN SOURCE AND HER CONDITION IMPROVED. ALLEGEDLY, THE C1000T CONTENTS INDICATOR READ HALF FULL BUT HAD NO OXYGEN FLOW. PRODUCT LABEL STATES THAT THE DEVICE IS INTENDED FOR SUPPLEMENTAL USE AND IS NOT CONSIDERED A LIFE-SUPPORTING DEVICE. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MFG PROCESS PER THE APPROVED DMR.
A PT PRESENTED WITH #13 SINGLE UNIT MOBILE, IMPLANT WAS REMOVED. NO SWELLING, EXUDATE PRESENT. PT IS REPORTEDLY FINE.
AN IMPLANT AND CROWN LOOSE-LOSS OF INTEGRATION #28 IMPLANT, #29 STABLE. PT IS REPORTEDLY FINE.
FURTHER COMMUNICATION WITH THE DR'S OFFICE, ON 8/21/96, REVEALED THAT ACCORDING TO THE NOTES IN THE PT'S FILE, THE DEVICE "WAS LEAKING." AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED ON 5/10/96, IT WAS ADDITIONALY STATED THAT THE DEVICE WAS LEAKING "AROUND THE CLAVICLE AREA." THE DEVICE WAS STATED TO HAVE BEEN DISCARDED AND IS, THEREFORE, UNAVAILABLE FOR EVALUATION. AS PART OF CO'S INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND ID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING HIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE FACILITY'S REPORT OF DEVICE LEAKAGE IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
ON 8/19/96, DURING A FOLLOW-UP CALL WITH THE FACILITY OR NURSE, THE MFR WAS INFORMED THAT THERE WERE TWO INCIDENTS INVOLVING THIS PT. THIS REPORT INVESTIGATES THE FIRST INCIDENT (SEE MFR 1219454-1996-00400 FOR ADD'L INFO REGARDING THE PT'S 2ND DEVICE). THE FACILITY OR NURSE STATED THAT THIS WAS A "STRANGE SITUATION" WHERE THE PT HAS RECENTLY RECEIVED HER 3RD IMPLANTED DEVICE. THE FIRST DEVICE WAS STATED TO HAVE BEEN IMPLANTED ON 3/14/95, AND IS ASSUMED TO HAVE BEEN REMOVED DUE TO THE SAME TYPE OF PROBLEM: LEAKING AND SPLIT OF THE DEVICE CATHETER.
EXTERNAL VISUAL INSPECTION IS OK. FILL TEST IS OK. CONTENTS INDICATOR FAIL. NORMAL EVAPORATION RATE IS OK. PRIMARY RELIEF VALVE IS OK. FLOW CONTROL TEST IS OK. CONCLUSION: THE CONTENTS INDICATOR MALFUNCTION WAS CAUSED BY A SPRING THAT WAS OUT OF SPEC. THE UNIT PASSED ALL OTHER FUNCTIONAL TESTS. THE UNIT HAS BEEN PLACED IN QUARANTINE DUE TO POTENTIAL LITIGATION AND A REPLACEMENT UNIT SENT TO THE CUSTOMER.
THE DEVICE WAS REMOVED DUE TO AN "INFECTION". THE PT IS TWO-WEEKS POST-IMPLANT HOWEVER, A SPECIFIC DATE WAS NOT PROVIDED.
REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. HOWEVER, BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTON OR PAIN, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF INFECTION AND PAIN AS THE REASONS FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QA INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
NO OSSEOINTEGRATION WITHOUT INFECTION. MAY BE DUE TO VASCULARISATION. PT IS REPORTEDLY FINE.
H3: EXAMINATION OF VALVE IN CO'S LAB REVEALED EXTENSIVE CALCIFICATION WITHIN EACH CUSP, INCLUDING CALCIFIC CLUSTERS MEASURING 1-12MM, WHICH RESULTED IN STENOSIS OF EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS, CONVOLUTED CUSPS AND INCOMPLETE COAPTATION. HOST TISSUE OVERGROWTH ENCROACHED ONTO RIGHT - CORONARY CUSP, CONTRIBUTING TO STENOSIS OF VALVE. X-RAY ANALYSIS REVEALED CALCIFICATION WITHIN AORTIC WALL, BELLY AND FREE MARGIN OF EACH CUSP. SLIGHT STENT DISTORTION WAS ALSO NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO EXTENSIVE CALCIFICATION. H6: 86= X-RAY.
THE DR'S OFFICE RETURNED A CALL TO THE MFR, ON 9/9/96, AND STATED THAT THE PT INDICATES THAT THE DEVICE DID NOT WORK; HOWEVER, THE PT'S CONDITION PROGRESSED AND AS A RESULT THE THERAPY STOPPED WORKING. THE PT'S REPORT THAT THE DEVICE IS NO LONGER FUNCTIONAL OF THE DEVICE. BASED ON THE INFO AVAILABLE THIS EVENT DOES NOT APPEAR TO BE ATTRIBUTABLE TO THE DEVICE OR A DEVICE MALFUNCTION, BUT TO DISEASE PROGRESSION. ALTHOUGH NOT PART OF THE MFR'S ORIGINAL 10/92, DEVICE SAFETY ALERT, INSTRUCTIONS PROVIDED IN THE ALERT GUIDELINES APPLY TO THIS DEVICE. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILES ON THIS EVENT.
ON 8/14/96, THE MFR RECEIVED A RESPONSE TO A DEVICE TRACKING POLLING LETTER. THE RESPONSE FROM THE PT STATES THAT "THE DEVICE IS NO LONGER FUNCTIONAL.
THE PT HAD PAIN DURING THE PLACEMENT OF THE ABUTMENT. THE PT RECEIVED ANOTHER IMPLANT NEAR THIS ONE, THE OTHER IMPLANT HAD NO PROBLEMS. IT IS STILL IN THE PT'S MOUTH AND DOING VERY GOOD. DR ELECTED TO REMOVED THE IMPLANT WITH PAIN.
METHOD (86): PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DISTRIBUTOR.
DYSFUNCTION", INSUFFICIENCY LEAFLET DISRUPTION AND DYSPNEA UPON EXERTION.
EXAMINATION OF VALVE IN CO LAB REVEALED SEPARATION OF AORTIC WALL FROM STENT POST BETWEEN RIGHT AND LEFT-CORONARY CUSPS. CONSEQUENTLY, SEPARATION ALLOWED AORTIC WALL TO PROTRUDE INTO ORIFICE CAUSING CONVOLUTED CUSPS AND INCOMPLETE COAPTATION. IN ADDITON, PROLAPSE ALLOWED FOR BIAS TAPE ABRASION OF BELLY OF RIGHT-CORONARY COSP. HOST TISSUE OVERGROWTH FUSED BOTH ATTACHMENT SITES OF NONCORONARY CUSP AND ENCROACHED ONTO EACH LEAFLET RESULTING IN STENOSIS OF EFFECTIVE ORIFICE AREA. X-RAY ANALYSIS REVEALED MINOR FOCI OF CALCIFICATION WITHIN AORTIC WALL OF EACH CUSP. STENT DISTORTION WAS ALSO NOTED WHICH APPEARED ARTIFACUTAL OF EXPLANT. PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO SEPARATION OF AORTIC WALL. THESE FINDINGS WOULD ACCOUNT FOR SYMPTOMS NOTED CLINICALLY. COMPLICATION OF SEPARATION OF AORTIC WALL HAS BEEN STUDIED OVER PAST FEW YEARS. FROM INVESTIGATION, CO HAS LEARNED THAT SEPARATION IS A DEGENERATIVE PROCESS THAT IS DEPENDENT ON TIME. IT OCCURS PREDOMINANTLY IN MITRAL POSITION AND IN LARGE SIZES. SEPARATED WALL IS TYPICALLY BETWEEN TWO LARGEST CUSPS ON VALVE, THAT IS, USUALLY, BETWEEN LEFT-CORONARY AND RIGHT-CORONARY CUSP, AS IN THIS CASE. CO'S STUDY OF THIS PHENOMENON LEADS US TO SUSPECT THAT DISRUPTION OF AORTIC WALL IN THIS AREA IS DUE TO A COMBINATION OF MECHANICA AND BIOCHEMICAL FACTORS. SEPARATION OF AORTIC WALL CANNOT BE SIMULATED IN CO'S IN VITRO TESTERS ALONE. MAJORITY OF VALVES SHOWING THIS COMPLICATION HAVE IMPLANT DURATIONS OF NINE YEARS OR MORE. DATA FURTHER SUGGESTS THAT PHENOMENON IS A DEGENERATIVE PROCESS REQUIRING A COMBINATION OF MECHAINCAL AND BIOLOGICAL FACTORS AND IS TIME-DEPENDENT. H6: 86= X-RAY ANALYSIS.
INITIAL BILATERAL IMPLANTATION WAS ON 7/12/73. LAWSUIT FILED ALLEGING UNDISCLOSED "DAMAGES".
PLAINTIFF ADOPTS MASTER PETITION FILED IN CAUSE NO. 92-16550: IN RE: MASTER SILICONE BREAST IMPLANT FILE, HARRIS COUNTY, TX. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
ON 8/16/96, THE MFR RECEIVED THE FOLLOWING RESPONSE TO A DEVICE TRACKING POLLING LETTER FROM THE PT'S FAMILY: "TO WHOM IT MAY CONCERN: THE PT PASSED AWAY ON 9/9/95, FOLLOWING ININSERTION OF THE MFR'S DEVICE AND COMPLICATIONS THERE OF. BE INFORMED THE FAMILY WAS NOT MADE AWARE OF THE TYPE OF DEVICE  THIS WAS. THERE WILL BE NO SIGNING OF CONSENT. IF YOU WISH DETAILS, CONTACT THE PHYSICIAN WHO DID THIS!" SIGNED THE FAMILY OF THE PT. ON 8/16/96, A MFR REP CONTACTED A DR FROM THE IMPLANTING DR'S FACILITY. THE DR REVIEWED THE PT'S FILE/RECORD AND STATED THAT THIS EVENT WAS DUE TO THE PT'S CONDITION, NOT DUE TO THE DEVICE OR DEVICE MALFUNCTION.
DUE TO THE UNAVAILABILITY OF THE DEVICE, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PEERFORMED ON SIMILAR INCIDENTS FOR THIS CAT NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT FOR THIS DEVICE BASED ON THE INFO AVAILABLE, THIS EVENT APPEARS TO BE DUE TO THE PT'S CONDITION, NOT DUE TO THE DEVICE OR A DEVICE MALFUNCTION. NO FURTHER DETAIL ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE DEVICE WAS IMPLANTED ON 6/24/96, FOR INFUSION OF FUDR THROUGH THE HEPATIC ARTERY FOR TREATMENT OF CANCER. ON 8/12/96, A FACILITY NURSE CONTACTED THE MFR'S CLINICAL REPRESENTATIVE. THE FACILITY NURSE STATED ON 8/5/96, DAY EIGHT (8) OF THE PT'S SECOND CHEMO CYCLE, THE DEVICE WAS REFILLED WITH FUDR/HEPARIN WITHOUT ANY PROBLEMS. THE FACILITY NURSE STATED THAT THE MFR'S REFILL KIT WAS USED; HOWEVER, SHE DID NOT DO THE RECOMMENDED 5CC NEEDLE PLACEMENT CHECK DURING INJECTION. TODAY (8/12/96), THERE IS PRESENCE OF SWELLING OVER THE DEVICE AREA. THE AREA IS NOT RED BUT IS WARM TO THE TOUCH. THE FACILITY NURSE THINKS THE AMOUNT OF SWELLING MAY MAKE ACCESSING THE DEVICE DIFFULT. THE FACILITY NURSE STATED THAT THE PT WAS PLAYING GOLF DURING THE PAST WEEK. THE FACILITY NURSE REQUESTED RECOMMENDATIONS. THE MFR'S CLINICAL REPRESENTATIVE ADVISED THE FACILITY TO ASPIRATE THE SUBCUTANEOUS FLUID USING A NEEDLE/SYRINGE DIRECTLY OVER THE SURFACE OF THE DEVICE TO AVOID ACCIDENTAL TRAUMA TO THE DEVICE CATHETER. ADDITIONALLY, THE MFR'S CLINICAL REPRESENTATIVE ADVISED THE FACILITY NURSE TO CONSIDER A CULTURE OF THE FLUID WITH THE PHYSICIAN. ALSO, ASSESS THE DEVICE SIDEPORT POSITION TO DETERMINE IF DEVICE ROTATION HAD OCCURRED. IF THE FACILITY NURSE IS ABLE TO ACCESS THE DEVICE CENTER SEPTUM, REFILL THE DEVICE CENTER SEPTUM WITH HEPARIN/NORMAL SALINE AS USUAL AND CHECK THE DEVICE FLOW RATE(R). THE MFR'S CLINICAL REPRESENTATIVE REQUESTED THE FACILITY NURSE CONTACT HER IF SHE HAD ANY QUESTIONS AND ASAP WITH FOLLOW-UP INFO. LATER THAT DAY (8/12/96), THE FACILITY NURSE CONTACTED THE MFR'S CLINICAL REPRESENTATIVE WITH A FOLLOW-UP. THE FACILITY NURSE STATED SHE WAS ONLY ABLE TO ASPIRATE 2-3CC OF SUBCUTANEOUS BLOODY FLUID. ADDITIONALLY, SHE INFORMED THE MFR'S CLINICAL REPRESENTATIVE THAT THE DEVICE SIDEPORT IS AT 12:00 O'CLOCK POSITION; HOWEVER, SHE WAS ABLE TO MOVE THE DEVICE ALONG THE CEPHALAD TOWARD THE CAUDAL AXIS, BUT THE DEVICE DOES NOT ROTATE EASILY (THE DEVICE SIDEPORT IS DOCUMENTED AT 14:00 O'CLOCK ON THE IMPLANT RECORD). THE PT STATED THAT HE FINISHED GOLF AT 1600 HRS ON 8/9/96, AND BEGAN EXPERIENCING DISCOMFORT AROUND THE DEVICE AREA AT 1800 HRS. THE RV = 19.5 DAYS AND THE FR = 4.31 ML/DAY. THE PREVIOUS FR'S OF THE DEVICE WERE AS FOLLOWS: 7/8/96 = 2.43ML/DAY; 7/15/96 = 2.29ML/DAY AND ON 8/5/96 = 4.31 ML/DAY. THE MFR'S CLINICAL REPRESENTATIVE RECOMMENDED A HAPS STUDY BE PERFORMED TO VERIFY THE DEVICE CATHETER POSITION. ALSO, THE DEVICE SIDEPORT CAUTIONS WERE DISCUSSED FOR NUCLEAR MEDICINE. THE MFR'S CLINICAL REPRESENTATIVE FAXED PAGE 26 FROM THE DEVICE CLINICIAN'S MANUAL AND AN ARTICLE ON PERFUSION SCINTIGRAPHY.
ON 11/11/96, A FACILITY NURSE INFORMED THE MFR'S REP THAT ON 11/4/96, A SCAB WHICH FORMED OVER THE DEVICE SITE CAME OFF AND OPENED A 3-4CM HOLE FROM WHICH OLD BLOOD AND FLUID OOZED OUT. THIS AREA WAS CLEANED UP BY A FACILITY NURSE. NO INFECTION WAS NOTED; HOWEVER, THE NURSE DID NOTE THAT THERE WAS NECROTIC TISSUE PRESENT. THE PATIENT WAS THEN SENT TO THE IMPLANTING PHYSICIAN, WHO DRAINED THE REMAINDER OF OLD BLOOD, CUT OUT THE NECROTIC TISSUE FROM THE SITE, INSERTED A PENROSE DRAIN AND THE AREA WAS CLEANED OUT. THE PATIENT RETURNED TO THE FACILITY ON 11/11/96 FOR A DEVICE REFILL. NO PROBLEMS WERE ENCOUNTERED ACCESSING THE DEVICE. THE PENROSE DRAIN REMAINED IN PLACE. THE PATIENT WAS DUE TO RETURN TO THE FACILITY ON 11/18/96. THE FACILITY NURSE STATED HE WOULD NOTE TO THE FILE REQUESTING THAT THE MFR BE CONTACTED WITH AN UPDATE ON PATIENT/DEVICE STATUS AT THAT TIME. DUE TO THE INSERTION OF THE PENROSE DRAIN, THE CUSTOMER REQUESTED THAT THIS FILE REMAIN OPEN FOR ONE OR TWO MORE DEVICE REFILLS. ON 11/20/96, THE MFR WAS INFORMED BY A FACILITY NURSE THAT THE PATIENT WAS IN THE FACILITY ON 11/18/96. THE PENROSE DRAIN REMAINED IN THE PATIENT AND WILL DO SO FOR A WHILE LONGER. THE DEVICE WAS FUNCTIONING AS INTENDED AND EVERYTHING APPEARED TO LOOK GOOD. THE PATIENT'S ABDOMEN LOOKS BETTER (NOT QUITE SO PUFFY) AND EVERYTHING APPEARS TO BE GOING WELL AT THIS TIME. ON 12/3/96, THE FACILITY NURSE CONTACTED THE MFR REP AND INFORMED HER THAT THE PATIENT AND DEVICE ARE DOING WONDERFUL. THE PATIENT WAS SEEN ON 12/2/96, THE ABDOMEN IS HEALING AND HAS GONE DOWN CONSIDERABLY. SHE STATED THAT SHE THINKS THE PATIENT HAS SLOWED HIS GOLF SWING DOWN A BIT. THERE IS A CONSIDERABLY SMALLER AMOUNT OF PUFFINESS OVER THE PUMP AREA; HOWEVER, SHE HAD A PROBLEM ACCESSING THE DEVICE. THE DEVICE SIDEPORT HAS BEEN STABLE IN THE 1:00 O'CLOCK POSITION AND THE DEVICE IS FUNCTIONING AS INTENDED. THE PENROSE DRAIN HAS BEEN REMOVED; HOWEVER, THERE IS STILL A SMALL AMOUNT OF SANGUINOLENT FLUID AT THE SITE WHERE THE PENROSE DRAIN WAS PLACED. THE DEVICE IS FUNCTIONING AS INTENDED, THE PATIENT IS DOING WELL AND TEH DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN. DUE TO THE DEVICE REMAINING IMPLANTED, THE MFR'S INVESTIGATION OF THIS INCIDENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT. BASED ON THE INFORMATION AVAILABLE, THE PROBLEM APPEARS TO HAVE BEEN RESOLVED. THE MFR'S INVESTIGATION AS TO THE CAUSE OF THIS INCIDENT IS INCONCLUSIVE. NO FURTHER DETAILS ARE AVAILABLE. THE CUSTOMER WILL BE NOTIFIED OF THE MFR'S FINDINGS. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
DR RETURNED A BROKEN ABUTMENT STATING IT WAS BROKEN, NO OTHER INFO GIVEN.
IN CO'S EVALUATION CO FOUND THE (O423) SHOULDERED ABUTMENT TO ACTUALLY BE A (0617) SHOULDERED ABUTMENT. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO WAS UNABLE TO REVIEW THE PRODUCT'S LOT HISTORY SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR'S OFFICE.
F1: USER FACILITY, F10: PT CODE: 2202, DEVICE CODE: 2204, F11: NO, F12L HOSPITAL, F13: NO, F14: REFER TO D3.
INITIAL IMPLANTATION WAS ON 6/10/82 WITH EXPLANT 7/2/96. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING BUT NOT LIMITED TO FEVER, RASHES, MEMORY LOSS, FATIGUE, AND DIZZINESS.
THE VALVE WAS IMPLANTED IN AN 8 YR OLD MALE PT APPROX 2-3 WEEKS AGO. THE PT DEVELOPED HEADACHES. SCAN SHOWED MIDLINE SHIFT/MASS DEFFECT WITH SUBDURAL HEMATOMA. UNKNOWN IF THE VALVE CAUSED/CONTRIBUTED TO SUBDURAL HEMATOMA FORMATION.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. REPORT REC'D FROM THE FIELD INDICATED THAT VALVE WAS IMPLANTED IN AN 8 YR  OLD MALE PT, APPROX 2-3 WEEKS PRIOR, WITH GOOD RESULTS. THE PT BEGAN TO DEVELOP SEVERE HEADACHES. HE WAS SCANNED AND EXHIBITED A SIGNIFICANT SUBDURAL HEMATOMA (SDH) WITH MIDLINE SHIFT/MASS DEFECT. LATER ANOTHER SCAN WAS PERFORMED, WHICH REVEALED INCREASED SDH. THE CAUSE FOR SDH IS NOT KNOWN. REPORTEDLY, THE CHILD EXHIBITS NO SIGNS OF HEAD INJURY AND IS WELL SUPERVISED. THE VALVE WAS EXPLANTED AND REPLACED UNEVENTFULLY WITH ANOTHER VALVE, THE PT IS CLINICALLY STABLE. THE PRODUCT HAS BEEN RETURNED TO CO BIOT FOR EVAL AND TESTING. PLEASE NOTE DATE OF 10/25/96 FOR SUBMISSION OF SUCH INFO PENDING COMPLETION OF THE ANALYSIS.
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE TISSUE AND APPLIED ANOTHER DEVICE. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
10/23/96 SINCE THE SUBMISSION OF THE INITIAL REPORT UNDER REFERENCE NUMBER 2647580-1996-65, CO HAS RECEIVED ADD'L INFO INDICATING THIS IS A DUPLICATE REPORT OF A PREVIOUSLY REPORTED SERIOUS INJURY MDR. THE PREVIOUSLY REPORTED SERIOUS INJURY MDR WAS SUBMITTED UNDER THE "OLD" MDR REGULATION WITH CO'S REFERENCE NUMBER 9608421, ASSIGNED ACCESS NUMBER M764623 BY FDA. ANY FUTURE CORRESPONDENCE CONCERNING THIS EVENT WILL BE REPORTED IN ACCORDANCE WITH THE ORIGINAL SUBMISSION.
ON 8/15/96 MFR NURSE REPORTED THAT REVISION SURGERY HAD BEEN SUCCESSFULLY PERFORMED ON 8/16/96. THE DEVICE WAS FLIPPED BACK OVER INTO THE PROPER POSITION, RESUTURED, AND REFILLED WITH DURAMORPH. THE PT WAS THEN SENT HOME. THE MFR NURSE REPORTED THAT SHE HAS FOLLOWED UP WITH THE FACILITY SINCE THE REVISION SURGERY WAS PERFORMED AND WAS INFORMED THAT THE PT IS DOING WELL AND NO FURTHER DIFFICULTIES ARE BEING EXPERIENCED. THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS PART NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. BASED ON THE AVAILABLE INFO. THIS EVENT APPEARS TO HAVE BEEN DUE TO A POSITIONAL ISSUE AND WAS NOT RELATED TO A DEVICE MALFUNCTION/FAILURE. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
THE DEVICE WAS IMPLANTED ON 7/17/96, FOR INTRATHECAL INFUSION OF MORPHINE. ON 8/14/96, THE FACILITY NURSE CONTACTED A MFR NURSE AND REPORTED THAT SHE HAD BEEN UNABLE TO ACCESS THE PT'S DEVICE TO REFILL IT. SHE HAD ATTEMPTED  TO REFILL THE DEVICE SEVERAL TIMES AND COULD NOT PALPATE THE DEVICE SEPTUM. ON 8/15/96, THE MFR NURSE MET WITH THE FACILITY NURSE AT THE FACILITY. THE PT'S DEVICE POCKET AREA AROUND THE RIGHT LATERAL FLANK REGION APPEARED ECCHYMOTIC DUE TO ERRORS IN THE PREVIOUS NEEDLE STICK ATTEMPTS. THE MFR NURSE THEN ATTEMPTED TO ACCESS THE DEVICE WITH A MFR 22 GAUGE NEEDLE; HOWEVER, SHE WAS UNSUCCESSFUL. THE MFR NURSE THEN INFORMED THE FACILITY NURSE THAT SHE FELT THAT THE DEVICE MAY HAVE FLIPPED IN THE DEVICE POCKET OR IT HAD BEEN SUTURED BACKWARDS WITH THE DEVICE SEPTUM FACING THE SPINAL CORD. RADIOGRAPHIC STUDIES WHICH WERE TAKEN LATER THAT MORNING ON 8/15/96, CONFIRMED AT THE DEVICE SEPTUM WAS FACING THE SPINAL CORD AND COULD NOT BE ACCESSED. THE PT WAS THEN SCHEDULED FOR REVISION SURGERY ON 8/16/96.S S
INITIAL BILATERAL IMPLANTATION WAS IN 1974. CONSUMER FURTHER REPORTS VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, ASTHMA, GRAVES DISEASE, AUTO-IMMUNE DISEASE, AND SJORGEN'S DISEASE.
PLATE WAS PLACED OVER HIP PROSTHESIS AND PRODUCT INSERT STATES AVOID PLACEMENT OVER METAL PROSTHESIS. NO SITE PREP WAS CONDUCTED, INSERT STATES TO PREP SITE.
HOSP ALLEGES PENCIL BURNED DRAPE WHICH CAUSED A BURN TO THE PT DURING A SURGICAL PROCEDURE. THE PT REPORTEDLY HAD TWO SEPARATE CIRCULAR 3RD DEGREE BURNS ON THE BACK.
THE CO PRODUCT MGR VISITED MEDICAL CENTER TO EVALUATE THIS INCIDENT. HE WAS PROVICED INFO BY THE DIR OF RISK MGMT, WHICH INCLUDED A PHOTOGRAPH OF THE BURN SITES. THE PRODUCT MGR CONCLUDED THAT THE BOVIE PENCIL COULD NOT HAVE CAUSED THE BURNS FOR THE FOLLOWING REASONS: 1) THE PT WAS PISITIONED ON HER SIDE, THEREFORE THE PENCIL COULD NOT HAVE BEEN LYING ON HER BACK TO CAUSE THE TWO BURNS. 2) THE GENERATOR EMITS AN AUDIBLE TONE WHENEVER THE PENCIL IS SWITCHED ON. THIS TONE WOULD HAVE ALERTED THE USER BEFORE THE PT COULD HAVE BEEN INJURED. 3) THE BURN MARKS WERE CIRCULAR: THE PENCIL IS LONG AND NARROW IN SHAPE.
THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE ANASTOMSIS LEAKED AND CAUSED PERITONITIS. THE PT DIED AT AN UNSPECIFIED TIME POST-OPERATIVELY.
10/23/96 THE FOLLOWING "SUMMARY OF FINDINGS" WAS INADVERTENTLY SUBMITTED UNDER CO'S FOLLOW-UP REPORT #1. PLEASE DISREGARD THIS INFO AS IT DOES NOT PERTAIN TO THIS REPORT. SUMMARY OF FINDINGS: CO HAS DETERMINED THAT DURING THORACIC PROCEDURES DUE TO THE LOCATION AND METHOD OF USE, THE USER CAN INADVERTENTLY DEPRESS THE RELEASE BUTTON WHILE CLAMPING THE APPROXIMATING LEVER. THIS CONDITION HAS BEEN ADDRESSED IN CURRENT PRODUCTION WITH PROCESS MODIFICATIONS THAT PREVENT THE JAWS FROM CLOSING WITH THE CARTRIDGE NOT FULLY SEATED.
THE FINAL INQUIRE, TELEMETRY, AND PRINT (ITP) SHOWED BATTERY VOLTAGE OF 0.27 VOLTS. THE ORIGINAL ITP SHOWED A VOLTAGE OF 2.74 VOLTS. THE DEVICE IS FUNCTIONING APPROPIATELY OTHERWISE.
NO ANALYSIS IS POSSIBLE WITHOUT THE DEVICE. TELEMETRY DATA ERRORS CAN OCCUR DUE TO WAND MOVEMENT OR ENVIRONMENTAL NOISE. THE SPECIFIC CAUSE IN THIS CASE COULD NOT BE DETERMINED.
TRACHEOSTOMY TUBE, WHILE IN PT, WAS FOUND TO BE TORN AWAY FROM THROAT PLATE, REMAINED CONNECTED BY ONLY THE PILOT LINE. CHILD IS 3 YRS OLD, VENTILATOR-DEPENDENT. TUBE HAD BEEN USED X 10 DAYS, CLEANED ONCE, ACCORDING TO DR'S ORDERS; CLEANED WITH STERILE WATER, BOILING WATER, THEN TAKEN AWAY FROM HEAT, THEN PLACED TUBE IN WATER X 5 MINS. TRACH ADAPTER CONNECTED VENTILATOR CIRCUIT TO TRACH TUBE.
THE DEVICE HAD AN INTERMITTENT LOSS OF VENTRICULAR SENSING.
THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING, ENVIRONMENTAL STRESS TESTING AND CONNECTOR DIMENSIONAL ANALYSIS. NORMAL PACER OPERATION WAS OBSERVED. THE BATTERY IS PARTIALLY DEPLETED-NORMAL.
THE DEVICE HAD AN INTERMITTENT LOSS OF ATRIAL SENSING AND A TOTAL LOSS OF ATRIAL CAPTURE. EXACT EVENT DATE IS UNKNOWN.
THE SURGICAL REVISION WAS COMPLETED ON 08/15/96. THE FRACTURED SCREW ON THE LEFT SIDE OF L4 AND AN UNFRACTURED SCREW ON THE RIGHT WERE EXPLANTED. BOTH SCREWS WERE REPLACED WITH 7MM SCREWS, ALONG WITH ADDITIONAL RODS AND NUTS. THE LINKING PLATES WERE PLACED FROM SIDE TO SIDE AT L5 AND L4 TO ADD ADDITIONAL STRENGTH. THE PATIENT WAS IN SATISFACTORY CONDITION POST-OP AND AT POST-OP OFFICE VISIT ON 08/28/96, PATIENT REPORTED TO BE DOING WELL.
THE DEVICE WAS USED DURING A HERNIA DISSECTION PROCEDURE. THE DEVICE BURST DURING THE PROCEDURE. THE SMALL PIECES FELL INTO THE PT. 8/7/96 THE SURGEON RETRIEVED ALL PIECES.
SECTION F CORRECTION: ALL INFO SUPPLIED ON THE INITIAL REPORT SHOULD HAVE BEEN NA BECAUSE NO USER FACILITY MEDWATCH REPORT WAS RECEIVED. RESULTS OF EVALUATION: CONCLUSION; AB) BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE BALLOONS HAD BURST DURING SURGERY, MAKING THE INSTRUMENTS NON FUNCTIONAL. A) THE INSTRUMENT WAS RECEIVED WITH A SMOOTH TRANSITIONAL TEAR WHICH RAN PARALLEL TO THE KNIT LINE, IN THE DISTAL PORTION OF THE BALLOON. THE TEAR WAS APPROX. 2.5 INCHES IN LENGTH. THE INITIAL POINT OF PROPAGATION COULD NOT BE DETERMINED. THE BALLOON WAS OBSERVED TO BE COVERED WITH DRIED BODY FLUIDS. B) THE INSTRUMENT WAS RECEIVED WITH A BALLOON WHICH HAD BURST AND ONLY 45% OF THE BALLOON WAS ATTACHED TO THE INSTRUMENT, THE REMAINING 55% OF THE BALLOON WAS NOT RETURNED. THE INITIAL POINT OF PROPAGATION COULD NOT BE DETERMINED. AB) THE INSTRUMENT WOULD NOT FUNCTION AS DESIGNED DUE TO A BALLOON WHICH HAD BURST. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE BALLOONS TO BURST. AB) EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
THE SALES REPRESENTATIVE WAS PERFORMING A ROUTINE FOLLOW-UP, ILLUSTRATING MANY OF THE FEATURES TO THE PACEMAKER NURSE. WHEN HE ATTEMPTED TO PERFORM A TEMPORARY PROGRAMMING FROM THE TEMPORARY SCREEN, GOING FROM DDD TO AAI MODE, THE PROGRAMMER RETURNED A "DEVICE RESET" SCREEN. THE REP PERFORMED A BACKUP RESET AND THE DEVICE FUNCTIONED APPROPRIATELY. THERE WERE NO FURTHER INCIDENTS NOTED WITH THIS PACEMAKER. EXACT EVENT DATE IS UNKNOWN.
F.12, F.6, F.8, F.9 - THIS DID NOT OCCUR IN A USER FACILITY; THEREFORE, THIS INFORMATION IS NOT APPLICABLE.
PT FOUND THAT DEVICES WERE SPLITTING AND LEAKING AT CONNECTION WITH HUBER HUBS.
TOTAL KNEE REPLACEMENT DONE 1989. FEMORAL COMPONENT FRACTURED AND NECESSITATED REPLACEMENT.
THE PT HAD R-WAVES OF 4 MILLIVOLTS, BUT THE AUTOSENSING WAS FOUND TO BE STUCK AT 6 MILLIVOLTS, THEREFORE, THE DEVICE WAS UNDERSENSING. THE SALES REPRESENTATIVE PROGRAMMED AUTOSENSING 'OFF'. IT IS SUSPECTED THAT THE PT HAD A LARGE AMPLITUDE R-WAVE (I.E.PVC) THAT PLACED THE 2:1 MARGIN AT 6 MILLIVOLTS. THEN THE R-WAVES DECREASED AND THE DEVICE WAS UNDERSENSING. NOTE: THERE IS AN A-A LIMIT FEATURE WHICH LIMITS THE MAXIMUM SENSITIVITY SO THAT IT DOESN'T BECOME TOO INSENSITIVE.
THE STAPLER WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE SAFETY SHIELD WOULD NOT ENGAGE. ANOTHER 355L WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
F1: USER FACILITY SHOULD NOT HAVE BEEN SELECTED. NO MEDWATCH WAS RECEIVED FROM USER FACILITY.
RPTR OPENED A BRAND NEW PACKAGE WHICH HAD PIECE OF WHAT LOOKED LIKE BLACK ELECTRICAL TAPE ON THE BELT. RPTR REMOVED THE TAPE TO SEE WHAT WAS UNDER IT AND FOUND THAT THE BELT HAD BEEN CUT AND TAPED BACK TOGETHER WITH BLACK ELECTRICAL TAPE. THIS MUST HAVE BEEN DONE AT THE FACTORY.
ON 7/12/96 THE CATHETER WAS INFLATED PRIOR TO CHOLELAPAROSCOPE SURGERY TO CHECK THE BALLOON WHICH APPEARED INTACT. EXTRAVASATION WAS NOTED DURING THE CHOLANGIOGRAM FROM THE BALLOON SITE. THE BALLOON HAD BEEN INFLATED WITH AIR, DEFLATED, AND REINFLATED WITH NORMAL SALINE, UP TO 1CC. THE PT RETURNED TO SURGERY ON 7/18/96 FOR REPAIR OF A COMMON BILE DUCT TEAR.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLELCYSTECTOMY. THE 355L WOULD NOT STAY ARMED. ALSO, IT DID NOT APPEAR THE SAFETY SHIELD WAS RETRACTING BACK FAR ENOUGH. THERE WAS NO CONSEQUENCE TO THE PT. ON 8/13/96 REP REPORTS ANOTHER 355L WAS OPENED TO COMPLETE THE PROCEDURE.
A1,2,3,4;B6,7;D10: INFOR UNAVAILABLE. 8/20/96 1540 COURTESY CALL TO RISK MGMT. 8/20/96 1520 WAS TOLD TO CALL SHARYN PRIOR TOMORROW. 8/21/96 AFTER 9AM. TKB 8/21/96 1440 SHARYN SAID SHE HAD NO PT INFO. TKB 8/21/96 1450 NNCL SENT. TKB G4: INFO UNAVAILABLE F1: USER FACILITY SHOULD NOT HAVE BEEN SELECTED. NO MEDWATCH WAS RECEIVED FROM USER FACILITY. G3: HEALTH PROFESSIONAL WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH
PT ADMITTED FOR EXPLANTATION OF CHIN IMPLANT. EXPLANTED 7/31/96. (*)
DEVICE NOT IMPLICATED, EVENT ATTRIBUTED TO USER ERROR.
STUCK VALVE SO IT OVERINFLATES SO THAT THE OXYGEN VALVE POPS OFF.
PORT WAS PLACED APPROX 2 WEEKS AGO. DEVICE IS LEAKING UNDER THE SKIN. DR REPORTS THAT WHEN DEVICE STUCK, THEY COULD DRAW BLOOD BACK BUT WHEN FLUIDS GIVEN, THE DEVICE LEAKS.
PT DIED OF CARDIAC CAUSES ON 8/14/96. ELECTROGRAMS RETRIEVED FROM THE  DEFIBRILLATOR SHOW THREE DETECTIONS OF VENTRICULAR FIBRILLATION. TWO DETECTIONS RESULTED IN ABORTED SHOCKS AND THE FINAL DETECTION RESULTED IN A SHOCK WHICH CONVERTED THE PT'S HEART RHYTHM.
D10. THERAPY DATES ARE NOT APPLICABLE TO THE CONCOMITANT DEVICES. THESE DEVICES ARE LONG-TERM IMPLANTABLES FOR WHICH CO CANNOT PROVIDE THERAPY DATES.
LAB EVALUATION SHOWED PRO-TIME GREATER THAN 100 SECS, FIBRINOGEN 436, PLATELET COUNT 227, AND 3+ SERUM PROTEIN. DIAGNOSIS OF COAGULOPATHY MADE WITH MEDICAL TREATMENT INCLUDING VITAMIN K, TRANSFUSION WITH FOUR UNITS OF FRESH FROZEN PLASMA. LABOR WAS INDUCED. DELIVERY OF VIABLE INFANT. PROTIME CONTINUED AT GREATER THAN 100 SECS. ADD'L MEDICAL INTERVENTION INCLUDED VITAMIN K, 8 UNITS OF FRESH FROZEN PLASMA. PT DEVELOPED SYMPTOMS OF PULMONARY EDEMA. MEDICAL TREATMENT WITH LASIX, DECREASED FLUIDS. PRO-TIME SENT TO REF LAB WITH RESULTS OF 7.4 SECS. PT RECOVERY WITH HOME DISCHARGE.
EVALUATION CODES FOR SECTION H6: 86 DEVICE WAS DISCARDED BY HOSP. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE "NCD" RESULT IS NOT A QUANTITATIVE RESULT. IT MEANS THAT A CLOT WAS NOT OBSERVED WITHIN THE ESTABLISHED CLOT OBSERVATION TIME FOR THE INSTRUMENT (WHICH IS DISCUSSED IN THE "THEORY OF OPERATION" SECTION OF THE OPERATOR'S MANUAL) AND THERE ARE A NUMBER OF POSSIBLE CAUSES FOR THIS RESULT, AND THIS INCLUDES: PROLONGED CLOTTING TIME, WEAK OR SLOW FORMING CLOT, EXTREMELY SHORT CLOT, BUBBLES IN PLASMA, INCORRECT FLUID LEVEL AND LIPEMIC SAMPLES. THESE ARE DISCUSSED IN THE OPERATOR'S MANUAL (PAGES ATTACHED). AND IT ALSO STATES "ALWAYS REPEAT A TEST FOR WHICH THE INSTRUMENT REPORTS NCD." THE LAB HAD LATER RESTESTED THE SAMPLE AT A REFERENCE LAB, AND THE PT RESULT WAS 7.4 SEC. WHEN CO RECEIVED THE MEDWATCH REPORT CO CONTACTED THE LAB. CORRECT PROCEDURES WERE DISCUSSED WITH THE LABORATORY AND RETRAINING WAS RECOMMENDED. THE LAB WILL AMEND THEIR PROCEDURES ACCORDINGLY. CO OFFERS TRAINING ON THE COAGULATION INSTRUMENTS. CO INTENDS TO MODIFY THE COURSE TO DISCUSS THE "NCD" RESULTS IN MORE DETAIL.
ALLEGED DEFLATION. FOLLOW-UP FINDINGS: AS PER HEALTH PROFESSIONAL PT ALSO HAD A PREVIOUS INFECTION AND CAPSULAR CONTRACTURE(GRADE IV).
THE POTENTIAL FOR THE ABOVE-NOTED EVENT TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFORMATION DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT HTE REPORT OR INFORMATION CONSTITUTES FAN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. MCGHAN MEDCIAL DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF MMC'S EVALUATION OF THE DEVICE. MCGHAN MEDICAL'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REJPORTING. FILING A MDR DOES NOT CONSTITUTE AND ADMISSION BY MMC THAT THE DEVICE HAD MALFUCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. REPORTS ARE BASED ON INFORMATION SUPPLIEDE TO MCGHAN MEDICAL AND THE SUBSEQUENT INVESTIGATION. CO CONSIDERS THIS INFORMATION TO BE HIGHLY CONFIDENTIAL AND, THEREFORE, REQUEST THAT FDA PROTECT IT FORM ANY REQUEST, PURSUANT TO 21 CFR JPART 803.9 (B). EVALUATION OF THE RETURNED DEVICE NOTED THAT DURING THE LEAK TEST THE VALVE LEAKED. THE DEVICE WAS IMPLANTED FOR 2 YEARS AND 3 MONTHS. THE EXACT CUASE OT THE DEFLATION IS UNKNOWN, HOWEVER, IT IS POSSIBLE THAT THE VALVE LEAKAAGE CONTRIBUTED TO THE DEFLATION. THE POTENTIAL FOR DEFLATION IS ADDRESSED IN THE LABELING AND IS NOT AN UNANTICIPATED EVENT.
A 91-YR-OLD PT WITH NUMEROUS DIVERTICULI UNDERWENT A COLONOSCOPY PROCEDURE DURING WHICH A (MECHANICAL) PERFORATION OF THE SIGMOID COLON OCCURRED. DURING WITHDRAWAL OF THE INSTRUMENT, THE PHYSICIAN REALIZED THE ENDOSCOPE HAD ENTERED THE PT'S PERITONEUM. THE PT WAS TAKEN TO SURGERY TO SUCCESSFULLY REPAIR THE PERFORATION. THE PT IS ALIVE AND WELL. ACCORDING TO THE LOCAL SALES REP WHO WAS PRESENT DURING THE PROCEDURE, THE PHYSICIAN DOES NOT BELIEVE THE EQUIPMENT WAS AT FAULT. THE PT'S CONDITION  CONTRIBUTED TO THE EVENT.
BASED UPON THE FACTS THAT THE SUSPECT DEVICE DID NOT FAIL, THE INSTRUMENT WAS WITHIN DEVICE SPECS AND THE PT'S CONDITION/ANATOMY PREDISPOSED HIM TO SUCH AN EVENT, IT WOULD APPEAR THAT THIS IS AN EXAMPLE OF AN INHERENT RISK ASSOCIATED WITH THIS TYPE OF MEDICAL PROCEDURE. AFTER THE SUSPECT DEVICE WAS RECEIVED AT FACILITY, IT WAS INSPECTED ACCORDING TO CO STANDARD OPERATING PROCEDURES FOR RETURNED PRODUCT. THIS EVAL INCLUDED NOT ONLY VISUAL EXAM OF THE DEVICE AND ITS PHYSICAL CHARACTERISTICS BUT PERFORMANCE AND OPERATION TESTS AS WELL. SINCE THIS SPECIFIC DEVICE IS USED "IN A SYSTEM", IT WAS ALSO CHECKED TOGETHER WITH THE CO'S "CONCOMITANT MEDICAL PRODUCTS(S)" IDENTIFIED IN SECTION D 10. THE SUSPECT DEVICE WAS ALSO COMPARED TO SIMILAR PRODUCTS IN INVENTORY. AS A RESULT OF THE ABOVE EVALUATIONS, IT WAS CONFIRMED THAT THERE WAS NO DEVICE FAILURE OR MALFUNCTION; THE DEVICE PERFORMED ACCORDING TO SPEC; NO DEVICE ABNORMALITIES WERE FOUND WHICH COULD HAVE PREVENTED OR INTERFERED WITH THE ABILITY FOR AN APPROPRIATELY LICENSED MEDICAL PROFESSIONAL TO USE THIS DEVICE AS INTENDED.
INCISION HAD TO BE WIDENED DUE TO A BROKEN HAPTIC.
THE COMPLAINT LENS AND QUESTIONNAIRE WERE NOT RETURNED AS OF 9/6/96. COMMENT WRITTEN ON CANCELLED IMPLANT CARD WAS "WASTED" IMPLYING LENS HAD BEEN DISCARDED. ADD'L INFO HAS BEEN SOUGHT. THE MFR'S INTERNAL REF NUMBER IS 96L3829.
ALLEGED DEFLATION. FOLLOW-UP FINDINGS: AS PER PHYSICIAN PT COMPLAINED OF PAIN IN LEFT BREAST. DEVICE WAS NOT DEFLATED.
PT'S NAME IN "E1" SECTION IS NOT PROVIDED TO MAINTAIN CONFIDENTIALITY.
CATHETER INFUSION DEVICE INTACT PER X-RAY 7/9/96. 7/23/96 PT COMPLAINED OF ABDOMINAL PAIN FOR 6 WEEKS. PORT A CATH DEVICE NOT OPERATIONAL. (ABLE TO GET BLOOD RETURN, RESISTANCE ENCOUNTERED WITH FLUSH ATTEMPT, WHICH WAS PROMPTLY HALTED). 7/23/96 CATHETER FRACTURED WITH DISTAL 10CM IN HEPATIC VEIN PER X-RAY FILMS. REMOVAL OF DEVICE BEING ARRANGED AS OP. ADMITTED 7/27/96 TO HOSP WITH ABDOMINAL PAIN AND FEVER. TRANSFERRED 7/30/96 TO ANOTHER MEDICAL CENTER.
A LEAKED OCCURRED AT THE ARTERIAL LUER CONNECTION TO THE PT'S INTERNAL JUGULAR CATHETER. THE HEALTHCARE PROFESSIONAL NOTICED THE LEAK 3 HOURS INTO TREATMENT. THE PT WAS HYPOTENSIVE THEREFORE SALINE WAS ADMINISTERED. DIALYSIS WAS DISCONTINUED AND THE PT WAS GIVEN ONE UNIT OF PACKED RED BLOOD CELLS. PT'S VITAL SIGNS WERE STABLE WHEN TRANSFERRED BACK TO ICU. THIS PT WAS GIVEN ANOTHER UNIT OF PACKED RED BLOOD CELLS IN ICU. THE PT INVOLVED IN THIS INCIDENT WAS IN THE HOSP'S INTENSIVE CARE UNIT PRIOR TO THIS INCIDENT FOR OTHER MEDICAL PROBLEMS. NO SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
ACCORDING TO THE REPORTER, THE PT WAS TRANSFERRED TO ANOTHER MEDICAL CTR. THIS  FACILITY CANNOT TRACE THE PT FROM THE INFO SUPPLIED TO DELTEC. IT IS THEREFORE UNK IF THE SYSTEM HAS BEEN EXPLANTED. EVALUATION OF DEVICE NOT POSSIBLE IF IT REMAINS IMPLANTED. IF EXPLANTED, DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. H11. ADDED D5; F2 (SUPPLIED VERBALLY BY REPORTER) AND F10; AND PORTIONS FO D6.
ALLEGED EFFUSION AND ABSCESS. FOLLOW-UP FINDINGS: POSSIBLE INFECTION OF UNKNOWN ETIOLOGY. REMOVAL OF (L) BREAST IMPLANT SECONDARY TO PERI-PROSTHETIC EFFUSION ABSCESS (L) BREAST.
REMOVAL OF (L) BREAST IMPLANT 20 TO PERI-PROSTHETIC EFFUSION ABSCESS (L) BREAST.
PT HAD THE SINGLE LUMEN PORT CATHETER INSERTED 3/20/96 FOR THE ADMINISTRATION OF CHEMOTHERAPY. THE PT EXPERIENCED PAIN AT THE SITE DURING A CHEMOTHERAPY INFUSION. AN ANGIOGRAM WAS PERFORMED AND DEMONSTRATED THE LEAK. PT HAD THE PORT EXPLANTED AND REPLACED WITH A SINGLE LUMEN PORT ON 8/15/96.
THE PORT WAS PLACED 7/20/96 FOR CHEMOTHERAPY. TWO WEEKS LATER, DURING FLUSHING WITH NORMAL SALINE, THE PT REPORTED BURNING. THE NEEDLE BECAME DISLODGED. WHEN THE PORT WAS REACCESSED, THE NURSE GOT A PINK BLOOD RETURN.
AT THE BREAK SITE, ONE SIDE OF THE TUBING ON THE PORT STEM WAS COMPRESSED AND THE WALL WAS THIN. THE MATCHING CATHETER SURFACE APPEARED TO HAVE BEEN SHEARED FROM THE OUTSIDE. THE TUBING ON THE PORT STEM HAD AN ANNULAR FLATTENING OPPOSITE THIS GOUGE. THIS APPEARS TO BE THE PLACE, WHERE THE CATHETER LOCKING SLEEVES PINCH FORCE WAS APPLIED. AS ALL THE DAMAGE OCCURED DISTAL TO THE BARB'S LOCKING SLEEVE INDICATES THAT THE CATHETER LOCK WAS NOT FULLY ENGAGED IN ITS LOCKED POSITION AT PLACEMENT.
BALLOON PIERCED 4 YRS AFTER PROCEDURE. ALTHOUGH COMPLAINANT REPORTED THAT PT WAS INJURED AS A RESULT OF THE INCIDENT, IT WAS ALSO REPORTED THAT THE DEVICE WAS NOT USED ON A PT AND THE PT'S CONDITION IS UNKNOWN. THE MFR HAS REQUESTED CLARIFICATION OF THE INFO RECEIVED HOWEVER RPTR HAD NO REPLY TO DATE.
H-10 INFO A3/E2 WERE PROVIDED ON INTIAL REPORT.
ADDED D5: D6. H3. THE USED PORTAL WAS RETURNED WITH TWO SECTIONS OF UNATTACHED CATHETER, ONE 7.5 INCHES IN LENGTH, THE SECOND 1.75 INCHES IN LENGTH. MICROSCOPY EXAMINATION OF THE OUTLET TUBE AND CATHETER SEGMENTS REVEALED A 0.5 INCH SLIT CUT ALONG THE LENGTH OF THE 7.5 INCH CATHETER SEGMENT APPROX 2.5 INCHES FROM ONE END. THE ORIENTATION AND PHYSICAL CHARACTERISTICS OF THE SLIT IS CONSISTENT WITH A SHARP INSTRUMENT HAVING BEEN USED AND CUTTING THE CATHETER.
THE PORT WAS PLACED 9/1/95 IN THE RIGHT JUGULAR VEIN ON THE SAME SIDE AS THE AS THE PT'S MASTECTOMY AND RADIATION THERAPY. THE PT REPORTED NOT GETTING GOOD BLOOD RETURN AND THE PORT COULD NOT BE USED FOR CHEMOTHERAPY. THE PORT WAS REMOVED IN 7/96 DUE TO INFECTION AND PORT OCCLUSION.
THE SPRING TIP BECAME SEPARATED FROM THE BODY OF THE CATHETER AND REMAINED IN THE PT'S VESSEL. IT HAD TO BE SURGICALLY REMOVED. THERE WERE NO OTHER REPORTS OF PT INJURY OR COMPLICATIONS. NO ADD'L DETAILS ARE AVAILABLE.
BLISTERS WERE NOTICED ON THE PT'S FEET AND LEFT ANKLE AFTER REWARMING IN PACU. THE PT WAS WARMED USING WARMING UNIT AND ANOTHER CO'S BLANKET.
WARMING UNIT WAS USED WITH A BLANKET NOT MFG BY CO. THIS PRACTICE IS CLEARLY WARMED AGAINST IN THE DEVICE LABEL AND INSTRUCTIONS FOR USE SINCE OTHER MFR'S BLANKETS DO NOT PERFORM THE SAME AS CO'S BLANKETS AND MANY DO NOT HAVE THE SAME SAFETY FEATURES AS CO'S BLANKETS. IN THIS CASE, THE OTHER CO'S BLANKET DOES NOT HAVE A FOOT DRAPE TO HELP PROTECT THE FEET AND ANKLES FROM COMING INTO CONTACT WITH THE HOSE DELIVERING THE WARM AIR. SINCE THE BLISTERS WERE ON THE FEET AND ANKLE IT IS VERY POSSIBLE THAT THE HOSE CAME INTO DIRECT CONTACT WITH THEM. THE MIXING OF THESE PRODUCTS HAS BEEN A CONCERN IN THE PAST, IS IDENTIFIED AS A CONCERN IN THE DEVICE LABELING AND IS PROHIBITED BY MANY REGULATORY BODIES.
DEVICE WAS REPORTED AS SURGICALLY REPLACED AFTER IMPLANTATION PERIOD OF THIRTY-EIGHT (38) MONTHS. REPORTEDLY, THE PT HAD PROGRESSED NORMALLY AFTER THE ORIGINAL TOTAL HIP ARTHROPLASTY. THEN, IT IS REPORTED, THAT THE PT WAS INVOLVED IN AN AUTOMOBILE ACCIDENT IN 12/95 IN WHICH THE PT'S VEHICLE FLIPPED OVER AND HE "HURT HIS LEFT HIP". SINCE THE ACCIDENT THE PT WAS REPORTED TO HAVE DEVELOPED INCREASED DISCOMFORT IN THE HIP WHICH LIMITED HIS ACTIVITIES. RADIOGRAPHIC EVALUATIONS WERE REPORTED TO HAVE REVEALED AN OSTEOLYTIC LESION IN THE GREATER TROCHANTERIC REGION WITH A FRACTURE ON THE GREATER TROCHANTER. DURING THE REVISION SURGERY ON 3/7/96, THE ATTENDING SURGEON REPORTEDLY OBSERVED PARTICULATE DEBRIS IN ADDITION TO THE ABOVE MENTIONED ISSUES. THE SUBJECT BEARING INSERT AND MODULAR FEMORAL HEAD WERE REPORTEDLY REPLACED, A CABLE WAS REMOVED, AND THE FRACTURED TROCHANTER WAS TREATED WITH ALLOGRAFT.
FOLLOW-UP REPORT #1 IS HEREBY BEING PROVIDED IN RESPONSE TO FDA'S REQUEST ON LETTER DATED SEPTEMBER 30, 1996. PLEASE NOTE: SECTION F OF THE ORIGINAL MED-WATCH SUBMISSION WAS NOT FILLED BY THE MFG. CO'S SINCE THE ORIGIN OF THE REPORT WAS RECEIVED VIA CO'S CLINICIAN. BASED ON THIS BLOCKS F1,F2,F3,F4,F5,F11 AND F13 ARE MARKED NA, AS NO USER FACILITY OR DISTRIBUTOR WAS PART OF THE ORIGINAL REPORT.
BLISTERS WERE NOTICED ON THE PT'S FEET AND ANKLES AFTER REWARMING IN PACU. THE PT WAS WARMED USING CO'S WARMING UNIT AND ANOTHER CO'S BLANKET.
UNIT WAS USED WITH A BLANKET NOT MFG BY CO. THIS PRACTICE IS CLEARLY WARNED AGAINST IN THE DEVICE LABEL AND INSTRUCTION FOR USE SINCE OTHER MFR'S BLANKETS DO NOT PERFORM THE SAME AS CO'S BLANKETS AND MANY DO NOT HAVE THE SAME SAFETY FEATURES AS CO'S MEDICAL BLANKETS. IN THIS CASE, THE OTHER CO'SBLANKET DOES NOT HAVE A FOOT DRAPE TO HELP PROTECT THE FEET AND ANKLES FROM COMING INTO CONTACT WITH THE HOSE DELIVERING THE WARM AIR. SINCE THE BLISTERS WERE ON THE FEET AND ANKLE IT IS VERY POSSIBLE THAT THE HOSE CAME INTO DIRECT CONTACT WITH THEM. THE MIXING OF THESE PRODUCTS HAS BEEN A CONCERN IN THE PAST, IS IDENTIFIED AS A CONCERN IN THE DEVICE LABELING AND IS PROHIBITED BY MANY REGULATORY BODIES.
PROSTHESIS WAS IMPLANTED ON 9/25/86 AND IS NOW LOOSE. REQUIRES REVISION.
DEVICE WAS REPORTED AS SURGICALLY REPLACED AFTER AN IMPLANTATION PERIOD OF (6) SIX MONTHS. REPORTEDLY, THE IDENTIFIED DEVICE WAS REVISED FOR LOOSENING.
SUBSEQUENT TO SUBMITTING THE ORIGINAL MEDWATCH REPORT THE PT'S OPERATIVE RECORD WAS RECEIVED AND FREVIEWED AND IT WAS DISCOVERED THAT JOINT DISLOCATION WAS ALSO INVOLVED. UPON REVISION SURGERY THE COMPONENT WAS FOUND TO BE LOOSE. FOLLOW-UP REPORT #1 IS HEREBY BEING PROVIDED IN RESPONSE TO FDA'S REQUEST LETTER DATED SEPTEBER 30, 1996. SECTION F OF THE FORIGINAL MED-WATCH REPORT SUBMISSION WAS FILLED OUT BY THEMFR. BECAUSE THE ORIGIN OF THE FREPORTED EVENT WAS ANOTHER CO'S CLINCIAN NOT A USER FACILITY OR A DISTRIBUTER. BASED ON THIS BLOCKS F1, F2, F3 F4, F54, F11 AND F13 ARE MARKED NA, AS NO USER FACILITY OR DISTRIBUTEOR WAS PRT OF THE ORIGINAL REPORT.
OTEHR DEVICES USED: CAT #00-6520-012-00 HGP REMORAL STEM, LOT #57896800, CAT #00-9026-032-00 HARRIS FEMORAL HEAD LOT #58601800, CAT #00-6524-013-00 BONE SCREW, LOT #57158400, CAT #00-6524-021-00 BONE SCREW, LOT #59231700, CAT #00-6524-026-00 BONE SCREW LOT #57994100. EVALUATION CODES FOR SECTION H6: 86, DIMENSIONAL CHECK WAS PERFORMED 100: DEVICE MEETS SPECIFICATIONS. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS TEH EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? U. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE PT WAS A POOR SURGICAL CANDIDATE, SO THE DECISION WAS MADE TO ATTEMPT STENT PLACEMENT. THE PHYSICIAN REMOVED THE PREMOUNTED STENT FROM THE DELIVERY SYSTEM AND HAND-CRIMPED IT ONTO ANOTHER BALLOON CATHETER. THE ATTEMPT TO ADVANCE THE DEVICE TO THE TARGET LESION SITE IN THE CIRCUMFLEX ARTERY WAS UNSUCCESSFUL. AS THE STENT AND BALLOON CATHETER WERE WITHDRAWN, THE STENT EMBOLIZED IN THE LEFT MAIN CORONARY ARTERY. RETRIEVAL ATTEMPTS WERE UNSUCCESSFUL. AN ADD'L BALLOON WAS USED TO COMPRESS THE STENT AGAINST THE VESSEL WALL. SUBSEQUENTLY, THE LEFT ANTERIOR DESCENDING ARTERY OCCLUDED. THE PT HAD A MYOCARDIAL INFARCTION, WAS INTUBATED AND PLACED ON AN INTRA-AORTIC BALLOON PUMP. THE PT ARRESTED AND WAS SUCCESSFULLY CARDIOVERTED. A TEMPORARY PACEMAKER WAS PLACED. THERE WERE NO ADD'L CLINICAL, SEQUELAE REPORTED RELATIVE TO THE EVENT AND THE PT'S CONDITION WAS REPORTED TO BE STABLE.
THE REMOVAL OR HAND-CRIMPING OF THE STENT ONTO OR FROM THE ORIGINAL BALLOON CATHETER TO ANOTHER BALLOON CATHETER IS NOT RECOMMENDED.
THE CUFF WAS REMOVED DURING THE ORIGINAL IMPLANT DUE TO A PERFORATION OF THE URETHRA. ON 1/16/96 THE BALLOON AND PUMP WERE REMOVED.
PUMP PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS.
AN AUS DEVICE WAS REMOVED FROM THE PT DUE TO EROSION. CO HAS REQUESTED ADDITIONAL INFO.
A BABY WAS LYING IN AN INCUBATOR WITH A BROKEN LEG.
NOTE 1: DEVICE WAS INSPECTED BY CO. ONE COMPONENT (MATTRESS EXTENSION WAS MISSING.
ON 9/10/93 AN AUS DEVICE WAS IMPLANTED. ON 1/5/96 THE CUFF WAS REVISED. ON 8/9/96 THE CUFF AND BALLOON WERE REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE AND FLUID LOSS.
AN AUS DEVICE WAS IMPLANTED ON 12/21/95. THE CUFF WAS REVISED ON 3/21/96. ON 8/7/96 A REVISION SURGERY WAS PERFORMED TO ADD A CONNECTOR TO THE PUMP TUBING DUE TO RECURRING INCONTINENCE.
OTHER DEVICES USED: CAT #00-9026-034-00 HARRIS FEMORAL HEAD LOT #50106700, CAT #00-6532-054-00 ACETABULAR CUP LOT #50034900, EVALUATION CODES FOR SECTION H6: 86, A DIMENSIONAL CHECK WAS PERFORMED 100: DEVICE MEETS SPECS. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE AND REPLACED.
H3: PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECS. BALLOON PRESSURE NOT WITHIN SPECS.
A PT WAS SKIN TESTED ON 4/30/96 WITH NEGATIVE RESULTS AND RECEIVED HER FIRST TREATMENT ON 6/6/96 IN THE GLABELLA, NASOLABIAL FOLDS, AND ORAL COMMISSURES. IN EARLY 8/96 (EXACT DATE UNKNOWN), THE PT NOTED REDNESS AND SWELLING AT THE SKIN TEST SITE AND GLABELLAR TREATMENT SITE. ON 8/5/96, THE PT PRESENTED WITH ERYTHEMA AND SWELLING AT THE GLABELLAR TREATMENT SITE AND SKIN TEST SITE. THE PHYSICIAN DIAGNOSED A HYPERSENTIVITY; ORAL ATARAX AND TOPICAL HYDROCORTISONE CREAM WERE PRESCRIBED.
THE CUFF WAS REMOVED FROM THE PT DUE TO EROSION.
THE PUMP AND BALLOON WERE REMOVED FROM THE PT DUE TO EROSION.
PUMP PERFORMED WITHIN SPECS. BALLOON PERFORMED WITHIN SPECS.
A PT WAS SKIN TESTED ON 3/22/96 AND 4/3/96 WITH NEGATIVE RESULTS, AND WAS TEATED ON 4/23/96 WITH 2 FORMULATIONS OF COLLAGEN IN THE GLABELLA AND NASOLABIAL FOLDS. ON 5/7/96, ERYTHEMA WAS NOTED AT THE NASOLABIAL FOLDS. THE SYMPTOMS RESOLVED ON 5/8/96. ON 5/9/96, ERYTHEMA AND TENDERNESS WERE NOTED AT THE NASOLABIAL FOLDS, AND SWELLING WAS NOTED AT THE UPPER LIP. SWELLING WAS ALSO NOTED AT THE SKIN TEST SITES AND LOWER LIP; EXACT DATE OF ONSET UNKNOWN. THE PHYSICIAN DIAGNOSED A HYPERSENTIVITY AND PRESECRIBED INTRAVENOUS STEROIDS AND ANTIHISTAMINES. AS OF 7/96 (EXACT DATE UNKNOWN), THE SYMPTOMS HAD RESOLVED.
THE PHYSICIAN REPORTED THAT THE SYMPTOMS RESOLVED AFTER ONE YEAR; IN APPROXIMATELY THE SUMMER 1997.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO STRESS INCONTINENCE.
PT DIAGNOSIS -OPEN RIGHT TIBIA AND FIBULA FRACTURE. DURING IRRIGATION AND DEBRIDEMENT AND INTERMEDULLARY RODDING OF THE RIGHT FIBULA  AND TIBIA FRACTURE, THE DRILL TIP BROKE. A SMALL FRAGMENT OF THE DRILL BIT WAS LODGED IN THE BONE. THE PT WAS DISCHARGED ON 8/2/96. NO COMPLICATIONS NOTED.
THE PUMP AND BALLOON WERE REMOVED FROM THE PATIENT AND REPLACED DUE TO SEVERE LEAKAGE-RECURRING INCONTINENCE. INFORMATION RECEIVED ON 11/7/96 INDICATES TISSUE ATROPHY BENEATH 4.5CM CUFF.
PT RECEIVED HER FIRST SKIN TEST ON 8/28/96 INTO THE FOREARM. TWELVE HOURS AFTER THE TEST, THE PT DEVELOPED SWELLING THE SIZE OF A HALF DOLLAR AT THE SKIN TEST SITE. SHE WAS SEEN ON 9/3/96 WITH A RAISED, HARD, WARM, RED AREA OF SIZE OF A HALF DOLLAR AT THE SKIN TEST SITE. THE PHYSICIAN DIAGNOSED A POSITIVE SKIN TEST AND PRESCRIBED INTRALESIONAL KENALOG AND TOPICAL TEMOVATE CREAM.
RE: ITEM A7 -THIS REPLACED ONLY USER FACILITY SUBJECT DEVICE AS A COURTESY. "SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFO WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR IT'S EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL DESCRIBED IN THIS REPORT."
THE BALLOON WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE AND REPLACED.
BALLOON PRESSURE NOT WITHIN SPECIFICATIONS.
AN AUS DEVICE WAS IMPLANTED, DATE NOT INDICATED. ON 7/19/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO ATROPHY OF THE CUFF.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE AND FLUID LOSS.
PUMP/TUBING JUNCTION HAD FATIGUE AND WEAR LEAK. CUFF PERFORMED WITHIN SPECIFICATIONS.
DRILL BIT BROKE IN PT, PORTION RETRIEVED IN ADD'L SURGERY.
SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFO WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR ITS EMPLOYEES,  THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.
AN UNSUBSTANTIATED LEGAL COMPLAINT WAS RECEIVED WHICH ALLEGES THAT THE PLAINTIFF DEVELOPED SYMPTOMS WHICH INCLUDE MYALGIAS, ARTHRALGIAS, HYPOTHERMIA OF THE LOWER EXTREMITIES, AND BREAST DISFIGUREMENT AFTER HAVING RECEIVED BREAST IMPLANTS.
AS THE DEVICES WERE NOT RETURNED, NO PHYSICAL EVALUATION WAS POSSIBLE, AND NO CONCLUSION COULD BE DRAWN. THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CUI CORP THAT THE REPORT OR INFO THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. REPORTS ARE BASED ON INFO SUPPLIED TO CUI CORP WITHOUT OUR INDEPENDENT VERIFICATION AS TO ITS ACCURACY OR COMPLETENESS. IT IS UNDERSTOOD THAT THE INFO MAY NOT REPRESENT FACT AFTER INVESTIGATION. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE NECESSARILY AN ACCURATE REFLECTION OF THE RESULTS AND CONCLUSIONS OF THE DEVICE EVALUATION.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION".
URINE WOULD NOT FLOW PAST THE ANTI-REFLUX VALVE INTO THE CATHETER BAG. THE PT COMPLAINED OF PRESSURE. WHEN THE BAG WAS REPLACED WITH A NEW BAG (A DIFFERENT BRAND) URINE FLOWED SPONTANEOUSLY.
PT WAS TREATED ON 9/4/96 WITH 2 FORMULATIONS OF COLLAGEN LAYERED TO THE NASOLABIAL FOLDS. IMMEDIATELY AFTER THE TREATMENT, BRUISING WAS NOTED AT THE TREATMENT SITES, WHICH WAS ATTRIBUTED TO THE INJECTION PROCEDURE. OVER-THE COUNTER BROMELAIN WAS PRESCRIBED. ON 9/5/96, THE PT PRESENTED WITH PERSISTENT BRUISING AT THE NASOLABIAL FOLDS WITHOUT EVIDENCE OF TISSUE BREAKDOWN. THE PHYSICIAN BELIEVED THE BRUISING WAS RELATED TO THE INJECTION PROCEDURE; ORAL CEFTIN AND TOPICAL VITAMIN K WERE PRESCRIBED.
ON 9/26/96, CLINICAL REPORT FORMS WERE RECEIVED FROM THE PHYSICIAN, WHO SPOKE WITH PATEINT BY PHONE ON 9/18/96; THE PATIENT REPORTED "EVERYTHING IS FINE" - BUISES GOEN IN 3 DAYS." THE AREAS WERE "SOFT AND NATURAL LOOKING" - "LOOKS GREAT". THE PHYSICIAN BELIEVED THE SYMPTOMS WERE POSSIBLY RELATED TO THE PROUDCT. THE PATIENT WAS ADVISED TO DISCONTINUE THE ORAL VITAMIN E 2 WEEKS PRIOR TO HER NEXT COLLAGEN TREATMENT.
ON 6/9/82 AN AUS DEVICE WAS IMPLANTED. ON 7/21/82 THE DEVICE WAS ACTIVATED. ON 2/28/85 THE CUFF AND CONTROL ASSEMBLY WAS REVISED. ON 8/8/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION" - WAS NOT WORKING.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO DEFECTIVE PUMP.
A MALE NON-COMPLIANT INSULIN DIABETIC WAS SEEN IN THE ER. NURSE TESTED PT AND RECEIVED "L ERROR" AND "USER ERROR" MESSAGES ON THE DEVICE. THE NURSE ASSUMED THIS MEANT THAT THE BLOOD GLUCOSE LEVEL WAS LOW AND TREATED WITH GLUCOSE, PRIOR TO RECEIPT OF LAB RESULTS. LAB RESULTS FROM SERUM SAMPLES DRAWN PRIOR TO TREATMENT WAS 1200 MG/DL, AFTER TREATMENT WAS 1600 MG/DL. THE LAB SUBSEQUENTLY TESTED EDTA SAMPLE (PRIOR TO TREATMENT) ON THE DEVICE THE RN HAD USED AND GOT "HI" MESSAGE. CONTROLS RUN ON THE METER THAT DAY WERE WITHIN RANGE. PT WAS ADMITTED TO THE HOSP.
ON 5/23/86 AN AUS DEVICE WAS IMPLANTED. ON 1/16/96 THE CONNECTORS WERE REVISED. ON 4/9/96 THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE-HOLE IN CUFF.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
EVENT CODES INDICATED BY THE DISTRIBUTOR OR ARE NOT ADDRESSED IN THE DEVICE LABELING. OVER MANY YRS, CO HAS PERFORMED FUNCTIONAL TESTING ON MANY 355904 STYLE BAGS AND HAVE NEVER FOUND PROBLEMS WITH THE ANTI-REFLUX VALVE. THIS TESTING IS PART OF THE MFG PROCESS AND AS PART OF OTHER COMPLAINT INVESTIGATIONS. CO FEELS THE REASON FOR THE COMPLAINT ON FLOW IS THE USER HAS OBSTRUCTED THE AIR VENT OR IT IS A PERCEPTION PROBLEM DUE TO THE SLOWER URINE FLOW INHERENT WITH AN ANTI-REFLUX DESIGN. A LABEL HAS BEEN ADDED TO THE SET TO WARN AGAINST OBSTRUCTION OF THE AIR VENT. FOR THIS MDR, CO HAS CONTACTED THE USING NURSE WHO INDICATED AN UNAWARENESS OF THE FILTERED VENT. IT WAS ALSO INDICATED THAT THE FACILITY PRACTICES A TWICE DAILY SOAP WASHING OF THE CATHETER AREA. SOAP ON THE VENT FILTER WILL PLUG THE FILTER AND AFFECT FLOW.
IMPLANT WAS EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. THE DR INDICATED THAT BONE LOSS, SMALL IMPLANT SIZE AND EXCESSIVE MANIPULATIONS OF THE PROSTHESIS DUE TO A POORLY FITTING CONNECTING BAR WERE CONTRIBUTING FACTORS. IT WAS NOTED THAT THE PT MAY BE A POSSIBLE HEAVY USER OF ALCOHOL.
86 = DIMENSIONAL ANALYSIS. 100 = THE RETURNED COMPONENT MET INTERPORE VISUAL AND DIMENSIONAL SPECS IN ALL RESPECTS. 68 AND 300 = DR INDICATED THAT BONE LOSS, SMALL IMPLANT SIZE AND EXCESSIVE MANIPULATIONS OF THE PROSTHESIS DUE TO A POORLY FITTING CONNECTING BAR WERE CONTRIBUTING FACTORS.
URINE DID NOT FLOW PAST THE ANTI-REFLUX VALVE INTO URINARY CATHETER BAG. THE PT COMPLAINED OF BLADDER DISCOMFORT. WHEN THE CATHETER BAG WAS REPLACED WITH A DIFFERENT), URINE FLOWED SPONTANEOUSLY.
VENTRICULAR ARRHYTHMIA, CARDIAC ARREST AND CEREBRAL DAMAGE.
DEVICE WAS REMOVED FROM THE PT DUE TO PUMP EROSION. ANOTHER DEVICE WAS IMPLANTED.
AN IOL WAS IMPLANTED IN THE PT AND NO COMPLICATIONS WERE NOTED. APPROX 2 MONTHS LATER EYE PAIN AND A DECREASE IN VISUAL ACUITY WERE EXPERIENCED. IRIS CAPTURE AND SECONDARY CLOSED ANGLE GLAUCOMA WERE DIAGNOSED AND THE PT HOSPITALIZED. AN OPERATION WAS PERFORMED TO RELEASE THE IRIS AND THE INCREASE IN IOP WAS NORMALIZED. SIX WEEKS LATER TRANSFORMATION OF THE PUPIL AND A DECREASE IN VISUAL ACUITY WERE REPORTED. AN IOL EXPLANT WAS PERFORMED AND A PMMA LENS WAS IMPLANTED. THE PT HAS EXPERIENCED NO FURTHER PROBLEMS. DEVICE EXPIRATION DATE: 12/31/00.
THE LENS WAS INSPECTED FOR LENS POWER, RESOLUTION, OVERALL LENGTH, OVERALL SHAPE, AND HAPTIC ANGULATION PRIOR TO SHIPPING. THE RETURNED LENS WAS INSPECTED AND FOUND TO BE WITHIN SPECS, HOWEVER THE OVERALL LENGTH AND HAPTIC ANGULATION HAD BEEN COMPROMISED WHICH IS NOT UNUSUAL FOR AN EXPLANTED LENS. THIS FORM CONTAINS ALL THE INFO THAT HAS BEEN RECEIVED FROM DR AS OF 9/9/96. THE MFR'S INTERNAL REF NUMBER IS 96L4508. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LAB, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16 THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CO THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITIY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MDEWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF CO'S EVALUATION OF THE DEVICE.
DEVICE WAS REMOVED FROM THE PT DUE TO PT DISCOMFORT.
RISK MGR STATED THE HOSP DOES NOT BELIEVE THE DEVICE MALFUNCTIONED. THE PT CODE 1685(CARDIAC ARREST) WAS REMOVED AND CODE 1802 WAS ADDED AS THE PT EXPIRED. A VISUAL AND FUNCTIONAL EVALUATION WAS PERFORMED AND THE DEVICE FUNCTIONED IN ACCORDANCE WITH THE DEVICE MASTER TESTING STANDARD.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION.
URINE DID NOT FLOW PAST THE ANTI-REFLUX VALVE INTO URINARY CATHETER BAG. THE PT COMPLAINED OF BLADDER DISCOMFORT. WHEN THE CATHETER BAG WAS REPLACED WITH A (DIFFERENT BRAND), URINE FLOWED SPONTANEOUSLY.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION-PAIN DUE TO SIZING.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDERS PERFORMED WITHIN SPECIFICATIONS.
RECEIVED MEDWATCH #05-0262-1996-0001 ON 8/29/96 "WHEN USING FEMORAL DISTAL GRAFT, DISSECTOR INSERTED AT GROIN TORE BRANCH OF SAPHENOUS VEIN."
THE VALVE WAS EXPLANTED DUE TO THE PT'S NONCOMPLIANCE WITH ANTICOAGULATION THERAPY. A THROMBUS WAS NOTED DURING EXPLANT. THE VALVE WAS RETURNED FOR ANALYSIS. ADD'L INFO HAS BEEN REQUESTED.
A 10/11MM TROCAR WAS PLACED IN THE ABDOMEN. THE SURGEON NOTICED A LOOSE SCREW ON THE GRIPPER PORTION OF THE LOWER RIGHT TROCAR. THE SURGEON ADJUSTED THE SCREW TO KEEP THE TROCAR IN POSITION. UPON INSEPCTION BLEEDING WAS OBSERVED. THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING SEVERAL TIMES BY SUTURE. HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL. THE TROCAR WAS REMOVED AND A LAPARATOMY WAS PERFORMED. THE SURGEON VISUALIZED A RAGGED MUSCLE WITH EVIDENCE OF RIGHT EPIGASTRIC INJURY LIGATION. THE MUSCLE EDGES WERE CAUTERIZED AND HEMOSTASIS NOTED.
PT ALLEGES HE SUFFERED LACK OF DEVICE LEAKAGE, EXTRUSION OF IMPLANT EXTERNALLY, SPONTANEOUS INFLATION, LOCALIZED PAIN, AND LOSS OF SENSATION.
8/16/96 1400 DR REPORTED THE PT EXPERIENCED BLOODY STOOLS FOR 12-18 HOURS POST-OP. AT THE EIGHT POST-OP HOUR, PT WAS TRANSFUSED WITH 3 UNITS OF BLOOD. NO OTHER INTERVENTION OR PROCEDURES WERE NECESSARY, AND PT HAS NOT RECEIVED FURTHER TREATMENT FOR THE BLEEDING. DR STATES THE PT'S COAGULATION STUDIES WERE WNL PRE-OP AND THE INSTRUMENRT FIRED WITHOUT DIFFICULTUY DURING THE CASE.
SURGEON EXPEREINCED A BLEEDING STAPLLED ANASTOMOSIS POST-OPERATIVELY. PT HAD 2 BOWEL MOVEMENTS WITH VERY BLOODY STOOLS. THE BLEEDING DID STOP WITHOUT INTERVENTION AND NO ADD'L PROCEDURES WERE NECESSARY. NO BUTTRESSING MATERIAL WAS USED.
EVENT CODES INDICATED BY THE DISTRIBUTOR ARE NOW ADDRESSED IN THE DEVICE LABELING. OVER MANY YRS, CO HAS PERFORMED FUNCTIONAL TESTING ON MANY 3T5904 SYTLE BAGS AND HAVE NEVER FOUND PROBLEMS WITH THE ANTI-REFLUX VALVE. THIS TESTING IS PART OF THE MFG PROCESS AND AS PART OF OTHER COMPLAINT INVESTIGATIONS. CO FEELS THE REASON FOR THE COMPLAINT ON FLOW IS THE USER HAS OBSTRUCTED THE AIR VENT OR IT IS A PERCEPTION PROBLEM DUE TO THE SLOWER URINE FLOW INHERENT WITH AN ANTI-REFLUX DESIGN. A LABEL HAS BEEN ADDED TO THE SET TO WARN AGAINST OBSTRUCTION OF THE AIR VENT. FOR THIS MDR, CO HAS CONTACTED THE USING NURSE WHO INDICATED AN UNAWARENESS OF THE FILTERED VENT. IT WAS ALSO INDICATED THAT THE FACILITY PRACTICES A TWICE DAILY SOAP WASHING OF THE CATHETER AREA. SOAP ON THE VENT FILTER WILL PLUG THE FILTER AND AFFECT FLOW.
H3: PUMP PERFORMED WITHIN SPECS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD TORN FABRIC AND BULGING.
DEVICE WAS REMOVED FROM PT DUE TO EROSION.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD OR DAMAGE.
URINE DID NOT FLOW PAST THE ANTI-REFLUX VAVLE AND INTO THE CATHETER BAG WAS REPLACED (WITH ANOTHER BRAND), URINE FLOWED SPONTANEOUSLY.
THE PATIENT HAS BEEN RELEASED FROM THE HOSPITAL AND IS PROGRESSING SATISFACTORY. WE BELIEVE THE INSTRUMENT WILL BE RETURNED TO CO. A1,2,4;B6,7;D5,10;H4: INFO NOT PROVIDED. H6-CODE 400: NICKED KNIFE. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY PRODUCED "MALFORMED STAPLES" DURING SURGERY. THE INSTRUMENT WAS RETURNED WITH A KNICKED KNIFE, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION, BUT HAD A ROUGH CUT DUE TO THE NICKED KNIFE. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO OTHER DEFORMATIONS COULD BE ID. THE EXPERIENCE TEH SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
8/20/96 SURGEON WAS PERFORMING A VAGINAL HYSTERECTOMY. SHE WAS USING THE EZ45 FOR CONTROL OF THE PARAMETRIAL TISSUES. SHE STATES THAT THIS WAS A 12 WEEK SIZE UTERUS AND THE OPERATIVE PROCEDURE APPEARED TO GO VERY WELL. AFTER THE COMPLETION OF THE PROCEDURE THERE WAS NOTED TO BE SOME BLEEDING. THE OOZE CONTINUED. AS A RESULT THE PATIENT WAS CONVERTED TO AN OPEN PROCEDURE. NO TRANSFUSION WAS REQUIRED, BUT THE POSTOP HEMAGLOBIN WAS 7.4. THERE WERE LOOSE STAPLES RECOVERED WHICH WERE EITHER INCOMPLETELY FORMED OR MALFORMED. SURGEON STATES THAT THOUGH THE INSTRUMENT APPEARED TO WORK VERY WELL, THE PROBLEM WAS THE INABILITY TO VISUALIZE THE PEDICLES BECAUSE THE INSTRUMENT HAD DIVIDED THE PEDICLES WHEN IT WAS FIRED. SURGEON ALSO STATES THAT SHE DID NOT UNDERSTAND WHY THERE WAS NOT A WAY OF VISUALIZING OR CONTROLLING THE PEDICLES AFTER FIRING THE INSTRUMENT. SHE STATED THAT SHE WAS TOLD THE INSTRUMENT WAS SPECIFICALLY DEVELOPED FOR VAGINAL HYSTERECTOMY.
INFO RECEIVED ON 8/15/96 INDICATES THE PT STATES AS A RESULT OF HIS IPP SURGERIES OF 1991 & 1993 HE SUFFERED INFECTION, DEVICE LEAKAGE, MECHANICAL MALFUNCTIONS, PAIN, DISFIGUREMENT, CONNECTOR LEAKAGE AND SEPARATION, LOSS OF LENGTH AND BURNING SENSATIONS UPON EJACULATION. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.
DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION.
THE DEVICE WAS USED DURING AN APPENDECTOMY. "DURING THE PROCEDURE THE INSTRUMENT WAS CLOSED WITH THE TISSUE ALREADY IN ITS JAWS. THE INSTRUMENT COULD NOT BE FIRED NOR OPENED AND HAD TO BE CUT OUT." AND ADD'L TROCAR WAS PLACED TO COMPLETE.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. DUE TO THE DAMAGED FIRING MECHANISM THE INSTRUMENT MAY BECOME DIFFICULT TO RELEASE FROM TISSUE. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
INFO RECEIVED ON 8/15/96 PT ALLEGES AS A RESULT OF HIS 6/90 IMPLANTATION HAS SUFFERED LACK OF SENSATION, LEAKAGE, LEG PAIN, AND LOCALIZED PAIN. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WOULD NOT INFLATE.
CYLINDER HAD A WEAR LEAK. CYLINDER HAD A WEAR LEAK.
THE TLC55 WAS USED DURING A LOW ANTERIOR RESECTION SOMETIME IN 5/95. REP REPORTED THE SURGEON REANASTOMOSED THE BOWEL USING THE TLC55 TWICE TO TRANSECT THE INTESTINE AND A THIRD TIME TO COMPLETE A FUNCTIONAL END TO END ANASTOMOSIS. HE CLOSED OFF THE SMALL INTESTINE WITH A TL60. THE ANASTOMOSIS LOOKED FINE SO THEY CLOSED THE PT. DR STATED THE PT BECAME VERY SICK AND HAD TO BE REOPERATED ON. HE THEN FOUND THE PT TO BE SEPTIC. HE STATED IT APPEARED THE ANASTOMOSIS HAD FALLEN APART AND THEY COULD FIND NO EVIDENCE OF STAPLES, THEY HAND SEWED THE ANASTOMOSIS AND TO DATE THE PT IS DOING FINE.
FACILITY REPORTED: AFTER APPROX 4 HOURS OF TREATMENT, PT'S VENOUS NEEDLE DISLODGED WHILE HE WAS SLEEPING, AND BELIEVED TO HAVE JERKED HIS ARM. PT LOST CONSCIOUSNESS FOR SEVERAL SECONDS THEN RESPONDED TO SALINE BOLUS. PT WAS TRANSFERRED TO ER HOSP FOR EVALUATION, SEEN AND RELEASED. EBL 500CC. REPORT INDICATED THAT EVENT OCCURRED ON 8/6 AND PT RETURNED TO UNIT ON 8/8. DIALYZED WITHOUT INCIDENT.
THE COMPLAINT IS NOT RELATED TO PRODUCT FAILURE BUT TO FACILITY'S FAILURE TO SAFELY SECURE THE PT'S NEEDLE DURING HEMODIALYSIS TREATMENT. NO LOT NUMBER FOR ALLEGED COMPLAINT AVAILABLE. COMPANION SAMPLE RECEIVED: NO INDICATION OF THE DEFECT FOUND DURING DHR REVIEW. LOT MET ALL RELEASE CRITERIA.
WHILE PREPARING FOR AN IV CATHETER INSERTION FOR ROUTINE RE-HYDRATION IN A PT, A SINGLE DROP OF LIQUID WAS NOTED ON THE TIP OF THE PLASTIC CATHETER. A DIFFERENT MAKE/MODEL/MFR DEVICE WAS THEN USED FOR THE PROCEDURE WHILE ALL CATHETERS OF THIS FIRST MAKE/MODEL/MFR WERE PULLED AND SEVERAL INSPECTED. THESE WERE ALL FOUND TO HAVE THE LIQUID, AN OILY SUBSTANCE ON THE TIP OF THE CATHETER. THIS IS NOT NORMAL IN RPTR'S EXPERIENCE AND AN INVESTIGATION WAS BEGUN. NO FURTHER USE WILL BE MADE OF THIS DEVICE PENDING THE RESULTS OF INQUIRY. THE SUBJECT WAS INVOLVED IN ONE SIMILAR COMPLAINT RECEIVED IN 1991 WHICH CITED "BUMPS ON TIP OF NEEDLE." THE MFR'S TESTS CONCLUDED THAT THE "BUMPS" WERE BEADS OF LUBRICANT. THE MFR WAS CONSULTED REGARDING THE CURRENT EVENT AND FEELS STRONGLY THAT THE DROP OF LIQUID ON THE TIP OF THE PLASTIC CATHETER IS ALSO A LUBRICANT. THE LUBRICANT POSES NO HAZARD TO PTS AND IS COMMONLY USED ON MANY INTRAVENOUS DEVICES. SUSPENDED UNITS ARE CONSIDERED SUITABLE FOR USE. IF THE COMPLAINANT WANTS THE MFR TO VERIFY THE LIQUID AS A LUBRICANT, A FEW NEEDLE UNITS MAY BE SENT TO THEIR ADDRESS ON THE COMPLAINT. A CUSTOMER SVC REP FROM THE FIRM CAN BE REACHED BY PHONE.
THE GRAFT WAS IMPLANTED 10/8/80 FOR AN AORTO-FEMORAL BYPASS. ON 6/26/96, THE GRAFT WAS EXPLANTED DUE TO AN ILIAC ANEURYSM. THE PT'S CONDITION IS GOOD.
SECTIONS OF THE RETURNED, EXPLANTED GRAFT WERE EVALUATED BY OUR CONSULTING PATHOLOGIST. A COPY OF THAT REPORT IS ATTACHED. IN OUR INITIAL REPORT, CODE 00 UNDER SECTION H6, "CONCLUSIONS" WAS STATED IN ERROR AND SHOULD HAVE BEEN STATED AS CODE 68 (DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, THEREFORE, NO CONCLUSION CAN BE DRAWN AT THIS TIME). GROSS DESCRIPTION: RECEIVED IN FORMALIN ARE NINE SEGMENTS OF TISSUE AND VASCULAR GRAFT WHICH MEASURE UP TO 3.0X2.5X0.7 CM. FOCAL FIBROUS TISSUE IS PRESENT ON THE OUTER SURFACE OF THE GRAFT. OTHER SEGMENTS OF TISSUE SHOW A LAMINATED THROMBUS PRESENT ON THE LUMINAL SURFACE OF THE VASCULAR GRAFT. REP SECTIONS ARE EMBEDDED UNDER MD-914, MD-915, AND MD-916. MICROSCOPIC DESCRIPTION: SEGMENTS OF A VASCULAR GRAFT EXPLANT ARE IDENTIFIED. FOCAL AREAS OF LOSS OF INTEGRITY OF THE GRAFT ARE IDENTIFIED. OTHER AREAS SHOW FOCAL PSEUDOINTIMA FORMATION ON THE LUMINAL SURFACE WITH THE PRESENCE OF COLLAGEN AND FIBROBLASTS. THE PERIADVENTITIAL SURFACE SHOWS THE FORMATION OF A FIBROUS CAPSULE WITH FIBROBLASTS AND COLLAGEN. FOCAL FOREIGN BODY GIANT CELLS, FIBROBLASTS AND COLLAGEN ARE PRESENT WITHIN THE INTERSTICES OF THE VASCULAR GRAFT. SEGMENTS OF A PSEUDOANEURYSM WITH A DECREASE IN FIBERS AND THE FORMATION OF A FIBROUS CAPSULE SURROUNDING A HEMATOMA ARE IDENTIFIED. SUMMARY: SEGMENTS OF A VASCULAR GRAFT WITH LOSS OF INTEGRITY OF THE GRAFT ARE IDENTIFIED. A WELL-HEALED LUMINAL SURFACE AND PERIADVENTITIAL SURFACE ARE PRESENT. A FOCAL PSEUDOANEURYSM WITH HEMATOMA IS IDENTIFIED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED, REASON NOT INDICATED.
INFO RECEIVED ON 8/16/96 INDICATES THE PT HAVING DIFFICULT DEFLATION, PENILE PAIN AND TENDERNESS. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.
THE LIDS TO THE SHARP'S CONTAINERS HAVE AN INSIDE LID THAT MOVE ON HINGES. ON OCCASION, ONE OF THESE HINGES BREAKS OFF, BUT OFTEN THE PRODUCT IS STILL USED. WHEN ONE OF THE HINGES IS BROKEN OFF OR THE INSIDE LID IS NOT USED, THERE IS A HOLE LEFT IN THE UPPER PORTION OF THE SHARP'S CONTAINER ALLOWING NEEDLES TO PUSH THROUGH CAUSING INJURY.
ON 5/3/99, A LETTER DATED 4/16/99 WAS RECEIVED INDICATING THAT THE DEVICE IDENTIFIER DID NOT MATCH THE BASELINE REPORT. A DEVICE IDENTIFIER OF R9010-38-25 WAS INDICATED ON THE LETTER. NO EVIDENCE OF AN IDENTIFIER OF R9010-38-25, USED ON MDR REPORT 2184002-1996-00182, WAS FOUND. CO HAS HOWEVER CREATED THIS FOLLOW-UP MDR REPORT TO REFLECT THE CORRECT BRAND NAME. INFO CONTAINED IN BLOCK D CORRECTLY INDICATES THE PRODUCT AND IS BELIEVED TO LINK UP WITH CO'S BASELINE REPORT.
6 RESTORE IMPLANTS ON THE SAME PT FAILED TO INTEGRATE. EXACT DATE OF OCCURRENCE IS UNK. ONE PERSON AFFECTED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS-LEFT CYLINDER.
EVENT CODES INDICATED BY THE DISTRIBUTOR ARE NOT ADDRESSED IN THE DEVICE LABELING. OVER MANY YRS, CO HAVE PERFORMED FUNCTIONAL TESTING ON MANY 3T5904 STYLE BAGS AND HAVE NEVER FOUND PROBLEMS WITH THE ANTI-REFLUX VALVE. A LABEL HAS BEEN ADDED TO THE SET TO WARN AGAINST OBSTRUCTION OF THE AIR VENT. FOR MDR, CO HAS CONTACTED THE USING NURSE WHO INDICATED AN UNAWARENESS OF THE FILTERED VENT. IT WAS ALSO INDICATED THAT THE FACILITY PRACTICES A TWICE DAILY SOAP WASHING OF THE CATHETER AREA. SOAP ON THE VENT FILTER WILL PLUG THE FILTER AND AFFECT FLOW.
IMPLANT PLACED 6/1/93, SITE #19. IMPLANT REMOVED 2/12/96, DUE TO INFECTION.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. THE REPORTED INFECTION IS THE LIKELY CAUSE OF FAILURE.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO HOLE IN CYLINDER WALL.
WHEN PACING WAS SELECTED ON THIS DEFIBRILLATOR, IT FAILED. THE DEFIB WAS BEING SET UP FOR AN ASYSTOLE PT WHO HAD ARRIVED IN THE ER. THE UNIT WAS ATTACHED TO THE PT VIA CABLES, AND THE PACING OPTION WAS SELECTED. IT FAILED IMMEDIATLEY AND THE NURSE SETTING UP THE DEFIBRILLATOR IMMEDIATELY CHANGED DEFIBRILLATORS WITH ANOTHER DEVICE OF THE SAME MAKE, AND THE PACING FUNCTIONED PROPERLY. THIS FAILURE IS THE NINTH DEFIBRILLATOR OUT OF THE PURCHASE OF SIXTY-NINE RPTR PURCHASED THIS YEAR. THE PREVIOUS EIGHT FAILURES WERE ALL DISCOVERED DURING DAILY/SHIFT CHECKS OR WHILE PERFORMING QUARTERLY PREVENTIVE MAINTENANCE. OF THE EIGHT FAILURES, THREE REQUIRED NEW POWER SUPPLY BOARDS, THREE REQUIRED CONTROL BOARDS AND ONE A NEW DEFIBRILLATOR PADDLE ASSEMBLY. THE EIGHTH HAD A PROBLEM THAT REQUIRED RESEATING ALL THE PLUGS/CABLES IN THE UNIT AND IT FUNCTIONED PROPERLY. CO EVALUATION OF THE DEFIBRILLATOR THAT FAILED WHEN PACING WAS SELECTED, INDICATED THAT THE PACER BOARD OUTPUT WIRE WAS NOT COMPLETELY CONNECTED. ONCE THIS WAS CONNECTED, THE PACER FUNCTIONED PROPERLY. CO WILL FILE A MALFUNCTION MEDICAL DEVICE REPORT (MDR) WITH THE FDA ON THIS FAILURE. IN ADDITION, A RECOMMENDATION WAS MADE TO THE USER TO INCORPORATE THE PACER FUNCTIONAL TEST, AS DESCRIBED IN THE USER'S GUIDE INTO THEIR ROUTINE DAILY DEFIBRILLATOR CHECKS. THIS PARTICULAR UNIT WAS ONE OF A LARGE ORDER FOR 69 SIMILAR UNITS. WITHIN THAT GROUP OF DEFIBRILLATORS THERE HAVE BEEN EIGHT OTHER FAILURES REPORTED TO OR FOUND BY CO. THESE WERE ALL FOUND DURING THE INITIAL SET-UP OR DURING SUBSEQUENT ROUTINE TESTING. NO PTS WERE INVOLVED. OF THE EIGHT FAILURES, FOUR PC BOARDS AND ONE PADDLE SET WERE RETURNED TO CO QA DEPT. OF THE FIVE COMPONENTS, THREE TESTED NORMALLY WITH "NO TROUBLE FOUND." THE REMAINING TWO DID SUFFER FAILURES, BUT OF DIFFERENT TYPES. BASED ON THE REPORTED PACER MODE FAILURE AND THE HISTORY OF EIGHT OTHER FAILURES, IT WAS DECIDED TO HAVE A FACTORY TEAM VISIT THE CUSTOMER SITE FOR A THOROUGH EXAMINATION OF ALL 69 UNITS TO VERIFY WHETHER OR NOT A CONSISTENT PROBLEM EXISTED IN THIS GROUP OF DEFIBRILLATOR. ALL 69 DEFIBRILLATORS WERE CHECKED FOR PROPER INTERCONNECT CABLE LATCHING, CALIBRATION OF DEFIBRILLATOR AND PACER OUTPUTS, AND TESTED FOR ELECTRICAL SAFETY. BASED ON THESE TESTS, ALL UNITS ARE FUNCTIONING PROPERLY AND HAVE BEEN PUT BACK INTO SVC. CO BELIEVES THAT THIS COMPLAINT HAS BEEN ADDRESSED TO THE SATISFACTION OF THE USER FACILITY.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE THE DEVICE WOULD NOT PUMP UP.
IMPLANT PLACED 3/22/96. EXFOLIATED 6/13/96. SITE #23, PT 20 YRS. ADD'L 3-4 IMPLANTS THAT WERE PLACED ARE ALL OK.
ON 10/2/96, SOME PT MEDICAL HISTORY WAS RECEIVED. THIS INFO INDICATES THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. THE INFECTION IS THE PROBABLE CAUSE OF FAILURE.
TWO IMPLANTS PLACED ON 4/4/96, 1 REMOVED ON 8/5/96. PT HAS NO HEALTH PROBLEMS.
EH RETURNED IMPLANT WAS CLEAN AND MET SPECS. THE REPORTED INFECTION IS THE LIKELY CAUSE OF FAILURE.
LOOSE LEFT TOTAL HIP PROSTHESIS. HIP PAIN PLUS SHORTENING. SETTLED DOWN TO CALCAR AND IS IN SIGNIFICANT VARUS CAUSING PRESSURE EROSION ON LATERAL CORTEX. REQUIRED REVISION OF THR.
INFO RECEIVED ON 8/15/96 INDICATES PT IS ALLEGING OF CURVATURE OF PENIS, DIFFICLUT TO INFLATE, UNABLE TO DEFLATE,LOSS IN LENGTH & GIRTH, AND THAT THE DEVICE FAILED TO OPERATE PROPERLY. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.
CYLINDER HAD OR DAMAGE.CYLINDER WAS FUNCTIONAL.
PT ALLEGES HE SUFFERED FROM COMPLICATIONS FROM MECHANICAL FAILURE.
OTHER DEVICE USED: CAT #00-9026-033-00 FEMORAL HEAD LOT #77328400. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE PT UNDERWENT A LAPARSCOPIC SURGERY. SHE PRESENTED TO THE HOSP'S ER ON 7/23/96, COMPLANING OF BLEEDING AND DISCOMFORT. THE ER DR REMOVED A "COHEN CANNULA" FROM THE PT'S CERVIX. THE CANNULA HAD BEEN LEFT IN THE PT'S CERVIX UPON COMPLETION OF THE LAPAROSCOPY. REMOVAL OF THE DEVICES WAS UNDER THE DIRECTION OF THE DR'S PRIVATE SCRUB NURSE.
THE DEVICE WAS REMOVED FROM THE PT AND RELACED DUE TO FLUID LOSS.
CYLINDER DID NOT MAINTAIN RIGIDITY.CYLINDER DID NOT MAINTAIN RIGIDITY.
CATHETER WAS BEING INSERTED INTO CEPHALIC VEIN FOR CENTRAL PLACEMENT. RESISTANCE WAS FELT. CLINICIAN STOPPED INSERTING AND CATHETER BOUNCED BACK. IT SEVERED AND EMBOLIZED TO THE LUNG. A TORNIQUET WAS APPLIED AND THE PT WAS TAKEN TO THE ER. THE EMBOLIZED PIECE WAS SUBSEQUENTLY REMOVED UNDER FLUOROSCOPY, IN RADIOLOGY.
FROM FOLLOW-UP INFO RECEIVED FROM RISK MGR. THE FOLLOWING IS THE LIKLIEST SCENARIO. THE CATHETER WAS BEING INSERTED WITH A GUIDEWIRE STYLET THROUGH CATHETER. THE RESISTANCE WAS LIKELY A VENOUS VALVE OR THE BEND IN THE CEPHALIC VEIN AS IT BECOMES THE AXILLARY. THE CATHETER AND WIRE BUNCHED AS RESISTANCE WAS MET UPON RELEASING HUB OF THE CATHETER, THE SPRING-WIRE CAUSED IT TO BOUNCE BACK AND CATHETER WAS CUT ON THE NEEDLE DEVICE AND EMBOLIZED. THERE WAS NO CLINICAL ERROR OR PRODUCT FAULT, A PURE ACCIDENT, FOR WHICH THERE IS NO EVALUATION CODE.
DATA IN SECTION D2 AND D6 AND CODES IN SECTION F10 WERE ADDED BY THIS MFR.
DEVICE WAS REMOVED FROM THE PT DUE TO PT DISCOMFORT AND BUCKLING IN ONE SIDE. ANOTHER DEVICE WAS IMPLANTED.
ADD'L INFO: PRODUCT WAS MANUFACTURED AND SOLD BY ANOTHER CO THE ASSETS OF WHICH WERE PURCHASED BY THIS COMPANY. INFO REQUESTED ON 9/30/96.
USER CLAIMS THAT A NEEDLE BROKE OFF WHILE INJECTING HERSELF WITH INSULIN. THE DR OPERATED ON PT THREE TIMES BEFORE REMOVING THE NEEDLE. THE USER ALSO CLAIMS THAT SHE SUFFERED FROM AN INFECTION AFTER THE SURGERY.
F1-F14 ARE NOT NEEDED TO BE FILLED OUT BECAUSE THE CONSUMER REPORTED ALL THE INFO DIRECTLY TO THE MFR.
PT WAS FOUND NO FLOOR AT SIDE OF BED WITH VEST RESTRINT ALLEGEDLY TIGHT ACROSS THROAT.
A 35 YR OLD FEMALE WITH HISTORY OF RECURRENT PNEUMOTHORAX HAD THORACOSCOPY WITH STAPLING OF PULMONARY APICAL BLEBS AND PLEURAL ABLATION ON 8/5/96. DURING THE PROCEDURE, THE STAPLER FAILED TO RE-OPEN AFTER FIRING CAUSING THE SURGEON TO CUT PT'S TISSUE FROM THE DEVICE. THE SURGEON USED THE BOVIE TO CAUTERIZE FURTHER BLEEDING POINTS. NO ADVERSE OUTCOME NOTED.
A REVISION SURGERY WAS PERFORMED TO IMPLANT A CONNECTOR DUE TO FLUID LOSS - HOLE IN TUBING. NO COMPONENTS WERE REMOVED OR REPLACED.
DATA TO DETEMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR UNAVAILABLE. DEVICE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.
THE FOLLOWING IS THE CLOSING OUT REPORT FROM FOREIGN REPORTER. EXAMINATION: SEAT SHELL WAS RETURNED. UNDERSIDE OF SHELL WAS HEAVILY CONTAMINATED. EXAMINATION RESTRICTED TO VISUAL ONLY. THE UNDERSIDE RETAINING RIBS SHOW EVIDENCE OF DISTORTION & BRUISING DUE TO BAD FITTING DURING CUSTOMER USE. THE DISTORTION ON RIB GAVE THE IMPRESSION THAT IT WOULD NOT CLIP ONTO THE CHAIR FRAME. CONCLUSIONS: THE SECURITY OF THE SEAT SHELL HAD BEEN SERIOUSLY IMPAIRED BY BAD FITTING, DUE TO USER ERROR IN MAINTENANCE. THIS IN TURN WAS MOST PROBABLY THE REASON FOR DETACHMENT.
ONE PERSON INVOLVED. IS NOT ON FILE FOR TEXT COPY.  ENTER TEXT.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-PUMP, TUBING BROKE AT BASE OF PUMP.
PUMP HAD A FATIGUE LEAK. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE.
PT WAS ADMITTED HERE ON 8/6/96 FOR OR ON 8/7/96. INITIAL IMPLANT ON 7/24/96, DISCHARGED ON 7/29/96 TO HOME. ON 8/1/96 HIP DISLOCATED AND WAS REDUCED UNDER GENERAL ANESTHESIA (NOT PERFORMED AT THIS HEALTH CTR). ON 8/5/96 HIP DISLOCATED AGAIN. INITIAL IMPLANT WAS PERFORMED AT THIS HEALTH CTR.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-ENTIRE SYSTEM.
ON 8/7 AT 5/A, THE PT AWOKE AND "HER HEAD FELT LIKE IT WAS GOING TO EXPLODE." SHE HAD BEEN OBTAINING READINGS IN THE "LOW 100'S FOR THE PAST TWO AND 1/2 WEEKS ON HER METER AND HAD CEASED TAKING HER INSULIN. HER HUSBAND TOOK HER TO SEE PHYSICIAN WHERE HER BLOOD PRESSURE WAS REPORTED TO BE 250/140 AND HER FASTING GLUCOSE WAS VERY HIGH (RESULT AND METHOD UNKNOWN). SHE WAS TAKEN STRAIGHT TO THE HOSP WHEN A NURSE TOLD THE PHYSICIAN THAT THE PT'S METER WAS 130-150 POINTS OFF FROM THE LAB (RESULTS UNKNWON). THE PT WAS ADMITTED FOR HYPERGLYCEMIA AND TREATED WITH 7U OF R INSULIN "MORE THAN TWO TIMES A DAY." SHE WAS RELEASED FROM THE HOSP ON 8/14. IT IS UNKNOWN HOW THE METER IS MAINTAINED. A CALIBRATION TEST WAS PERFORMED ON 8/13 INDICATING THAT THE METER WAS OUT OF CALIBRATION. THE RESULT WAS 59 VERSUS A RANGE OF 74-100.
CO HAS COMPLETED ITS INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINENANCE, OR SOME UNK ANOMALY. AT THIS POINT CO'S INVESTIGATION OF THIS MATTER IS CLOSED.
DEVICES REMOVED 2 WEEKS POST-OP FOR DISLOCATION. COMPONENTS WERE REPLACED WITH DEVICES MORE SUITABLE FOR THE PTS ANATOMY.
ON 12/4/79 DEVICE WAS IMPLANTED. ON 9/18/86 THE CYLINDERS WERE REVISED. 5/28/96 THE PUMP WAS REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
CO SYRINGE INFUSION PUMP WITH 60CC SYRINGE CONTAINING D5W WITH DOBUTAMINE SET TO INFUSE AT .28CC/HR. WITHIN THE FIRST 10 MINUTES OF THE INFUSION, ALL 60CC INFUSED INTO THE PT AND PT EXPERIENCED CARDIOPULMONARY ARREST. PUMP WAS IMMEDIATELY DISCONNECTED FROM PT AND PT WAS RESUSCITATED AND STABILIZED TO PREARREST STATUS.
THE DEVICE WAS APPLIED DURING A SIGMOID COLECTOMY PROCEDURE, REPORTEDLY, THE PREMIUM CEEA 31 WAS TOO LARGE TO PASS THROUGH THE COLON SO THE SURGEON REQUESTED A SMALLER SIZE (PPCEEA 28) INSTRUMENT. THE ANVIL OF THE PPCEEA 28 WAS INADVERTANTLY USED ON THE PCEEA 31 WHICH CAUSED THE INSTRUMENT TO JAM AND NOT OPEN. THE SURGEON RESECTED THE TISSUE AND COMPLETED THE PROCEDURE BY MANUAL SUTURE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO PAIN, DISCOMFORT AND MALFUNCTION.
PUMP PERFORMED WITHIN SPECS.CYLINDER PERFORMED WITHIN SPECS.CYLINDER PERFORMED WITHIN SPECS.RESERVOIR HAD OR DAMAGE.
CO'S EVALUATION IS COMPLETE. CO WAS UNABLE TO DUPLICATE THE OVERDELIVERY REPORT THROUGH FLOW TESTING. THE HISTORY RECORDS WERE DOWNLOADED. THIS EVENT RECORD INDICATED THAT THE DEVICE WAS PROGRAMMED AT 5 MG/KG/MIN IN BODY WEIGHT MODE, WHICH CORRESPONDS TO A DELIVERY RATE OF 280 ML/HR, NOT O.28 CC/HR AS WAS REPORTED.
ON 9/15/93 DEVICE WAS IMPLANTED. ON 2/23/96 A CONNECTOR WAS REVISED. IN 6/96, DAY NOT INDICATED, THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO SPONTANEOUS EROSION.
REAR TIP EXTENDERS WERE ADDED TO THE DEVICE BECAUSE THE CYLINDERS WERE TOO SHORT. NO COMPONENTS WERE REMOVED OR REPLACED.
PT EXPERIENCED SEVERE TENDERNESS AND PAIN AT SITE OF PREVIOUS SURGERY-11/93. PATELLA, FEMORAL AND TIBIAL IMPLANTED. SURGERY OF 8/14/96 REDUCED DIAMETER OF KNEE CAP DURING REVISION AND REPLACED PATELLA AS SCHEDULED PREOP.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO "MECHANICAL FAILURE".
CONCLUSION STATEMENT: UNABLE TO REACH CONCLUSION. ACCOUNT REFUSES TO SEND DEVICE FOR EVALUATION. LOT HISTORY OF DEVICE REVIEWED AND WAS FOUND TO BE COMPLETE, ACCURATE, AND ACCEPTABLE.
DEVICE WAS REMOVED FROM THE PT DUE TO A "BROKEN IMPLANT." ANOTHER DEVICE WAS IMPLANTED.
INFO RECEIVED ON 7/30/96 INDICATES ANOTHER DEVICE WAS IMPLANTED ON 7/3/96. INFO ACQUIRED ON 8/13/96 INDICATES A MALLEABLE DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. UNABLE TO OBTAIN ADD'L INFO.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-LEFT CYLINDER.
PUMP PERFORMED WITHIN SPECS.RESERVOIR PERFORMED WITHIN SPECS.CYLINDER PERFORMED WITHIN SPECS.CYLINDER HAD A WEAR LEAK.
ALTHOUGH THE USER FACILITY REPORTS THAT THE INFO WAS PROVIDED TO GORE ON 7/31/1996, WE HAVE NO RECORD OF THAT OCCURRENCE. PT'S OPERATIVE NOTES WERE ATTACHED TO USER REPORT AND ARE INCLUDED WITH THIS FOLLOW-UP REPORT.
43-YEAR-OLD MALE ADMITTED ON 7/21/1996 WITH SEVERE LIFE-THREATENING HYPERKALEMIA WITH CONGESTIVE HEART FAILURE. PT IS ON CHRONIC HEMODIALYSIS AND RECENTLY HAD A SHUNT REPLACED WHICH WAS AN UPPER ARM LOOP CONFIGURATION WITH RECURRENT REACCUMULATION OF FLUID IN THE AXILLA. PT UNDERWENT AN EVACUATION AND DEBRIDEMENT OF LEFT AXILLARY FLUID MASS AND REPLACEMENT OF SHUNT USING 8 MM RING. PTFE8 CM IN LENGTH INTERPOSITION GRAFT ON 7/31/1996. THE GRAFT WAS NOTICED TO BE WEEPING FLUID THROUGH THE INTERSTICES OF THE GRAFT. THE PT WAS DISCHARGED HOME ON 8/3/1996.
UPON REMOVAL OF THE IAB AFTER 44 HRS OF USE BLOOD WAS NOTED IN THE TUBING. THE PT WAS REPORTED TO HAVE EXPIRED A FEW HRS LATER, HOWEVER, THE PERFUSIONIST STATED THAT THE DEATH WAS DUE TO ILLNESS AND NOT RELATED TO THIS EVENT.
ON ORIGINAL MEDWATCH REPORT S/B MFR NOT DISTRIBUTION REPORT.
THE DEVICE WAS APPLIED DURING A WEDGE RESECTION PROCEDURE, REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED TISSUE AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
THE DISPOSABLE LOADING UNIT RETURNED WITH THE INSTRUMENT DISPLAYED MICROSCOPIC EVIDENCE INDICATING PROPER STAPLE FORMATION WAS NOT ACHIEVED. THE DEVICE WAS RETURNED WITH DAMAGE TO THE ANCHOR BLOCK COMPONENTS INDICATING THE STAPLER WAS CLOSED OVER AN EXCESSIVE AMOUNT OF TISSUE. THE PRODUCT INFO BOOKLET WHICH ACCOMPANIES EACH SHIPMENT ADVISES THE USER ON THE APPROPRIATE TISSUE THICKNESS FOR APPLICATION OF THIS DEVICE. IN CONCLUSION, CO FEELS THE USER ATTEMPTED TO CLOSE THE STAPLER OVER TISSUE OF A CONTRAINDICATED THICKNESS RESULTING IN DAMAGE TO THE INSTRUMENT AND AN IMPROPER FIRING
THE RIGHT CYLINDER WAS REMOVED FROM THE PT DUE TO INFECTION.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION - CONCEALMENT PROBLEM
THE TIBIAL INSERT HAS POPPED OUT PER X-RAYS. MAY BE TRAUMA RELATED.
CONCLUSION STATEMENT: RECORDS REVIEWED OF PRODUCT LOT FILE AND FOUND TO BE COMPLETE, ACCURATE, AND ACCEPTABLE.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CONNECTOR WAS FUNCTIONAL.
DEVICE WAS IMPLANTED ON 11/19/93. THE RIGHT CYLINDER WAS REMOVED ON 12/22/93. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT DUE TO FLUID LOSS ON 8/15/96 AND ANOTHER DEVICE IMPLANTED. ADDITIONAL INFORMATION RECEIVED ON 8/27/96 INDICATES THE RESERVOIR WAS LEFT IN PLACE DURING THE 8/15/96 SURGERY.
USER INSERTED SWAB INTO EAR CANAL AND TIP BECAME LODGED IN EAR CANAL. REQUIRED MEDICAL ATTENTION TO REMOVE TIP TO PREVENT INFECTION.
THE EVENT RESULTED FROM MISUSE OF THE DEVICE IN THAT IT WAS INSERTED INTO THE EAR DESPITE PACKAGE LABEL WARNING NOT TO DO SO.
ON 9/23/88 AN AUS DEVICE WAS IMPLANTED. ON 12/8/89 THE BALLOON WAS REVISED. SOME TIME IN 1993 THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
DEVICE WAS REMOVED FROM THE PT DUE TO CYLINDER MIGRATION OUT OF POSITION. ANOTHER DEVICE WAS IMPLANTED. UNABLE TO OBTAIN ADDITIONAL INFO.
PT BROUGHT TO HEART CATH LAB FOR ATHERECTOMY TREATMENT. TEMPORARY PACEMAKER INSERTED VIA RIGHT VENOUS SHEATH (FEMORAL) & WAS PROPERLY PLACED. AFTER PROCEDURE, IT WAS REMOVED. PT TAKEN TO ROOM. PT BEGAN HAVING DISCOMFORT & HYPOTENSION. PT RETURNED TO HEART CATH LAB. MD DETERMINED TEMPORARY PACEMAKER HAD PUNCTURED HOLE IN RIGHT VENTRICLE. PERICARDIOCENTESIS PERFORMED. PT TOLERATED IT WELL. RETURN HOSP ER 7/28/96. PERICARDIOCENTESIS REPEATED.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO LEAK AT TUBING.
PUMP PERFORMED WITHIN SPECS.RESERVOIR PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS.CYLINDER PERFORMED WITHIN SPECS.TUBING HAD OR DAMAGE.
DURING AN EP STUDY FOR SVT/RF ABLATION, THE STIMULATOR REPORTEDLY MALFUNCTIONED DELIVERING OUTPUT AT AN INTERVAL OF APPROX. 8MSEC. PT DEVELOPED VENTRICULAR TACHYCARDIA WHICH CEASED UPON DISCONNECTION OF THE STIMULATOR. NO FURTHER TREATMENT WAS REQUIRED. NO SUBSEQUENT ADVERSE EFFECTS HAVE BEEN REPORTED.
SECTION B AND F. INFO FROM THE INITIAL REPORTER WAS NOT SUBMITTED ON FDA FORM 3500A. INFO FOR SECTIONS B AND F10 ARE BASED UPON DATA PROVIDED BY THE USER. F10--PT CODE+=2132 DEVICE CODE=1162,1182. SECTIONS H3 AND H6. ANALYSIS OF THIS UNIT IS ON-GOING. THE EVALUATION SUMMARY WILL BE SUBMITTED IN A FOLLOW-UP REPORT.
THE RECORDS OF 95 MALE PTS IN WHOM A DOUBLE CUFF AUS WAS IMPLANTED BETWEEN 1986 AND 1995 WERE REVIEWED. TEN OF 95 PTS REQUIRED REMOVAL OF ONE OR BOTH CUFFS DUE TO EROSION. TWO HAD REIMPLANTATION, ONE HAD DEVICE REMOVED DUE TO INFECTION, ONE REQUIRED TEMPORARY URINARY DIVERSION WITH A SUPRAPUBIC TUBE, AND SIX REQUIRED REVISION FOR MALFUNCTION OR URETHRAL ATROPHY.
INFO RECEIVED ON 8/13/96 INDICATES DR COMPLETED A SURGERY AND TRIED TO USE THE DEVICE. THE DEVICE DID NOT FUNCTION AS DESIRED AND HE HAD TO REMOVE THE DEVICE. ADD'L INFO ACQUIRED ON 9/5/96 INDICATES "DIFFICULT ACTIVATION." NO FURTHER INFO CAN BE OBTAINED AT THIS TIME.
THE DEVICE WAS APPLIED DURING A PARTIAL GASTRECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE STAPLE DID NOT FORM PROPERLY. THE SURGEON RESECTED THE STAPLE LINE AND COMPLETED THE PROCEDURE BY MANUAL SUTURE.
THE DEVICE WAS EVALUATED AND MICROSCOPIC EVIDENCE WAS PRESENT INDICATING THE STAPLES AT THE PROXIMAL END OF THE CARTRIDGE FORMED PROPERLY AND THE STAPLES AT THE DISTAL END OF THE CARRIAGE DID NOT CONTACT THE ANVIL PROPERLY. THIS CONDITION WAS ATTRIBUTED TO THE USER FAILING TO SEAT THE ALIGNMENT PIN PROPERLY BEFORE FIRING.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDERS.
PUMP PERFORMED WITHIN SPECS.RESERVOIR PERFORMED WITHIN SPECS.CYLINDER WAS FUNCTIONAL.CYLINDER HAD A FATIGUE LEAK.
DEVICE WAS REMOVED FROM THE PT DUE TO CUFF EROSION.
DEVICE WAS REMOVED FROM THE PT DUE TO AN ANEURYSM IN THE RIGHT CYLINDER AND REPLACED.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A TORN FABRIC AND BULGING.
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT AND REPLACED DUE TO PAIN.
PUMP WAS NOT FUNCTIONALLY TESTED CUFF HAD OR DAMAGE BALLOON TUBING HAD A WEAR LEAK.
ADD'L INFO RECEIVED ON 9/24/96 INDICATES PT ATTESTS THAT THE DEVICE HAS NEVER WORKED SINCE IMPLANTATION. TUBING SUTURE TIE CONNECTION DISRUPTION MAY HAVE OCCURRED.
PUMP PERFORMED WITHIN SPECS.RESERVOIR PERFORMED WITHIN SPECS.CYLINDER PERFORMED WITHIN SPECS.CYLINDER HAD A TORN FABRIC AND BULGING.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS. ANOTHER DEVICE WAS IMPLANTED.
TUBING WAS FUNCTIONAL.TUBING HAD OR DAMAGE.PUMP PERFORMED WITHIN SPECS.RESERVOIR PERFORMED WITHIN SPECS.CYLINDER HAD OR DAMAGE.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AND WOULD NOT INFLATE. ANOTHER DEVICE WAS IMPLANTED.
TUBING HAD A FATIGUE LEAK.PUMP PERFORMED WITHIN SPECS.RESERVOIR PERFORMED WITHIN SPECS.CYLINDER PERFORMED WITHIN SPECS.CYLINDER PERFORMED WITHIN SPECS.
INFO RECEIVED ON 8/16/96 INDICATES THE IPP DEVICE WAS REMOVED FROM THE PT, DATE AND REASON NOT INDICATED. CO HAS REQUESTED ADDITIONAL INFO.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION", DISRUPTION OF RIGHT ANGLE CONNECTOR BETWEEN PUMP AND CYLINDER ON LEFT SIDE.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CONNECTOR WAS NOT FUNCTIONALLY TESTED.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A HOLE IN THE CYLINDERS.
PUMP PERFORMED WITHIN SPECS.RESERVOIR PERFORMED WITHIN SPECS.CYLINDER WAS FUNCTIONAL.CYLINDER WAS FUNCTIONAL.TUBING HAD A FATIGUE LEAK.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION, UNSATISFACTORY INTERCOURSE.
CYLINDER PERFORMED WITHIN SPECS.CYLINDER HAD OR DAMAGE.
ON 8/7/90 DEVICES WAS IMPLANTED. ON 7/7/96 THE TUNICA WAS REPAIRED, NO COMPOINENTS WERE REMOVED OR REPLACED. ON 8/13/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-LEFT CYLINDER.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS.
PUMP PERFORMED WITHIN SPECS.RESERVOIR PERFORMED WITHIN SPECS.CYLINDER WAS FUNCTIONAL.CYLINDER HAD A WEAR LEAK.TUBING WAS FUNCTIONAL.
ADD'L INFO RECEIVED ON 10/30/96 INDICATES LEFT CYLINDER INVADED DISTAL URETHRA.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS - RESERVOIR.
TUBING WAS FUNCTIONAL.PUMP PERFORMED WITHIN SPECS.RESERVOIR PERFORMED WITHIN SPECS.CYLINDER PERFORMED WITHIN SPECS.CYLINDER WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WOULD NOT INFLATE AND REPLACED.
DEVICE WAS REMOVED FROM THE PT DUE TO A MALFUNCTION AND REPLACED. UNABLE TO OBTAIN ADDITIONAL INFO.
A CONNECTOR WAS REMOVED FROM THE PT DUE TO A MIGRATION/DISLOCATION AND REPLACED.
THE CYLINDERS WERE REMOVED FROM THE PT DUE TO FLUID LOSS AND REPLACED.
CYLINDER PERFORMED WITHIN SPECS.CYLINDER HAD A WEAR LEAK.
DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION. ANOTHER DEVICE WAS IMPLANTED.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WOULD NOT INFLATE. ANOTHER DEVICE WAS IMPLANTED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED DUE TO A NON-FUNCTIONING DEVICE.
CYLINDER HAD A WEAR LEAK. CYLINDER HAD OR DAMAGE.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE THE DEVICE WOULD NOT INFLATE.
RPTR WAS TRAPPED BETWEEN THE WALL AND THE EXERCISE TABLE HANDLE WHEN THE EXERCISER SUDDENLY ACTIVATED, WHILE SHE WAS ADJUSTING THE BACK PAD WITH THE SWITCH IN THE OFF POSITION. THE ACTION OF THE TABLE DROVE THE HANDLE INTO HER ABDOMEN WITH AN UP AND DOWN MOTION FOR SEVERAL MINUTES CAUSING "SERIOUS INTERNAL ABDOMINAL AND EPIGASTRIC INJURIES."
THE PHYSICIAN HAD DIFFICULTY ON INSERTION BECAUSE BALLOON WAS VERY DIFFICULT TO GET THROUGH SHEATH. PHYSICIAN HAD TO BEAR DOWN. OF THE 3 PRODUCTS USED, ALL OF THE PROXIMAL ENDS OF THE BALLOON MEMBRANE HAVE APPEARED TO BE "UNWRAPPED" ONCE REMOVED FROM THE PACKAGE. INSERTION WAS A PROBLEM DURING SHEATHED INSERTION, AS WELL AS SHEATHLESS. THE ONE SHEATHLESS INSERTION HAS TO BE ABORTED BECAUSE THE "UNWRAPPED" PROXIMAL END WOULD NOT ENTER THE ARTERY. THERE WERE NO REPORTED COMPLICATIONS.
MFR CONTROL NO DI96-179. THE DEVICE WAS RETURNED FOR EVALUATION. THE 40CC CONNECTOR PLUG WAS MISSING AND IN ITS PLACE WAS ANOTHER MFR'S BROKEN ADAPTER. THE BLADDER WAS UNWRAPPED. THIS INCIDENT IS STILL UNDER INVESTIGATION, AND CO IS ATTEMPTING TO GET MORE INFO IN AN EFFORT TO BETTER UNDERSTAND THE CAUSE OF THIS INCIDENT. A FOLLOW-UP REPORT WILL BE FORWARDED AS SOON AS EVALUATION IS COMPLETED.
VAGUE REPORT THAT SOME SIGNIFICANT TIME AFTER THE START OF AN INFUSION, LITTLE OR NO SOLUTION EMPTIED FROM THE SOLUTION CONTAINER. THE INFUSION RATE OR VOLUME OF FLUID WAS NOT REPORTED. NO PT INJURY RESULTED. THE REPORTER EXPRESSED CONCERN THAT THE FLATTENING OF THE IV TUBING CAUSED THE REPORTED OCCURRENCE. THE BIOMED. DEPT. AT THE HOSPITAL EVALUATED THE INFUSION PUMP AND FOUND THE FLOW ACCURACY ACCEPTABLE WHEN THE TUBING WAS LOADED APPROPRIATELY. SOME FLATTENING OF THE IV TUBING IN THE PUMP NORMALLY OCCURS DURING THE INFUSION. THE CAUSE OF THE REPORTED OCCURRENCE IS MOST LIKELY IMPROPER LOADING OF THE IV TUBING INTO THE INFUSION PUMP. THE OPERATOR'S MANUAL INSTRUCTS TO "VISUALLY CHECK THAT THE TUBING HAS BEEN PROPERLY LOADED (NOT TWISTED, LOOSE, OR STRETCHED), THEN CLOSE THE PUMP DOOR." IT ALSO INSTRUCTS TO "CONFIRM FLOW BY OBSERVING DROPS IN THE ADMINISTRATION SET DRIP CHAMBER."
SECTION F COMPLETED BY THE MFR. THE REPORTER CONFIRMED PROPER OPERATION OF THE PUMP WHEN IT WAS LOADED APPROPRIATELY. THE INFUSION PUMP WAS THEREFORE NOT RETURNED TO CO FOR EVAL.
CHEST X-RAY INDICATED THAT CATHETER WAS BROKEN; CARDIAC CATHETERIZATION WAS PERFORMED ON 8/5/96 TO REMOVE PORT FROM RIGHT ATRIUM. ON 8/7/96, PORT CATHETER LINE WAS REMOVED FROM LEFT SUBCLAVIAN AREA.
ACCOUNT REPORTS "ON 2 OCCASIONS T-CONNECTOR HAS BEEN RIPPED APART FROM END ATTACHED TO HEPARIN LOCK." NO ADVERSE PT EVENTS BUT "POTENTIAL RISK."
SECTION F COMPLETED BY CO. NO OTHER INFO IS AVAILABLE. EVALUATION SUMMARY: RETURNED ONE USED BLOODY INTERLINK EXTENSION SET. VISUALLY NOTED THAT THE FEMALE ADAPTER WAS SEPARATED FROM THE TUBING POSSIBLY DUE TO INSUFFICIENT SOLVENT. SOLVENT WAS PRESENT ON THE TUBING. THE CONDITION OF THE SAMPLE RECEIVED WAS SUCH THAT FURTHER INVESTIGATION WAS NOT POSSIBLE. CONTACT AT FACILITY STATED THAT, "WE DON'T DO THAT, "WHEN ASKED TO SPEAK TO END USER TO DISCUSS EVENTS. PER CONTACT, "I CAN SEE IF THERE WAS SOME ADVERSE EVENTS BUT THERE WAS NONE AND NOT AWARE OF ANY PT INCIDENTS FORMS."
WHILE GIVING AMP BICARB IVP THRU A NORM SALINE, DRIP WIDE OPEN, MALFUNCTION WITH IV TUBING WHICH BROKE AWAY AT SITE THAT FITS IN PUMP. IV TUBE WAS NOT ON A PUMP AT TIME OF INCIDENT.
THE IAB WAS INSERTED ON 8/9/96 IN THE OR VIA A CUT DOWN. (68 YEAR OLD WHITE FEMALE. DIAGNOSIS: OPEN HEART CABG) AT 9:08 AM IN SICU, HI PRESSURE ALARMS SOUNDED ON THE PUMP AND THE NURSE NOTED FLECKS OF BLOOD IN THE TUBING. THE PT WAS TAKEN BACK TO THE OR FOR REMOVAL. THERE WERE NO REPORTED COMPLICATIONS.
MFR CONTROL NO DI96-177. THE DEVICE WAS RETURNED FOR EVALUATION. THE IAB WAS SUBMERGED IN WATER AND INFLATED WITH A 60CC OF AIR. BUBBLES WERE OBSERVED AT A POINT 15CM FROM THE DISTAL TIP IN AN ABRADED AREA 2.5CM IN LENGTH, AND THE HOLE IN THE BLADDER WAS APPROX 3MM IN LENGTH. BALLOON RUPTURES ARE A RECOGNIZED POTENTIAL COMPLICATION OF INTRA AORTIC PUMPING, GENERALLY OCCURRING IN THE PRESENCE OF ATHEROSCLEROSIS. PRODUCT LABELING ADDRESSED THIS POTENTIAL AND ACTION TO BE TAKEN.
DURING ATTAMPTED ABDOMINAL AND SMALL MESENTERIC ANGIOGRAM APPROX 13 CM FRAGMENT OF THE GUIDE WIRE LEFT IN RIGHT GROIN AT RIGHT FEMORAL ARTERY. SURGICAL REMOVAL OF FOREIGN BODY AT RIGHT GROIN, SPECIMEN SENT TO PATHOLOGY.
THIS 31-YR-OLD FEMALE UNDERWENT BAM IN 1989 AT ANOTHER FACILITY, THEREFORE, THIS REPORTING FACILITY DOESN'T HAVE ACCESS TO THE MFR INFO. THE PT PRESENTS WITH CAPSULE CONTRACTURES AND DISPLACEMENT OF THE IMPLANTS. GROSS EXAM: THE RIGHT IMPLANT IS FOCALLY RUPTURED, WEIGHING 160 GRAMS. THE IMPLANT EXUDES A GELATINOUS TRANSPARENT GEL-LIKE MATERIAL. THE LEFT IMPLANT IS INTACT.
ON 7/12/96 CATHETER WAS INSERTED VIA LEFT SUBCLAVIAN. THERE WAS RESISTANCE OF CATHETER OVER GUIDEWIRE SO CATHETER WAS REPLACED WITH ANOTHER. ON 7/19 DURING A ROUTINE CHECK UP A 1CM PIECE OF GUIDEWIRE WAS FOUND IN SUBCLAVIAN VEIN. THIS PIECE HAD NOT BEEN REMOVED AS OF THE TIME OF THIS REPORT. THERE WERE NO PT COMPLICATIONS.
THIS 64-YR-OLD FEMALE UNDERWENT SILICONE GEL BREAST IMPLANTATION ABOUT 14 YRS AGO. THE NAME OF THE MFR IS UNKNOWN TO THIS REPORTING FACILITY. GROSS EXAM: THE RIGHT IMPLANT IS INTACT. THE LEFT IMPLANT IS RUPTURED AND TORN. UPON REMOVAL IT WAS FOUND RUPTURED AND FREE SILICONE WAS IN THE CAPSULAR CAVITY.
FOLLOWING A NORMAL LABOR AND DELIVERY, PHYSICIAN ATTEMPTED TO REMOVE CATHETER FROM PT  AND WAS UNSUCCESFUL. CATHETER "BROKE OFF" LEAVING APPROX. 6" OF CATHETER IN PT'S EPIDURAL SPACE. FACILITY WILL LEAVE CATHETER IN PLACE.
SECTION F COMPLETED BY CO. NO ADD'L INFO AVAILABLE. EVALUATION: CHARACTERISTIC SAMPLE NOT AVAILABLE FOR EVAL. REVIEW OF PRODUCT REPORTING DATA BASE REVEALED NO SIMILAR REPORTS FOR THIS CODE AND LOT. REVIEW OF MFR PRODUCTION RECORDS REVEALED NO ABERRANCIES.
A 20-YR-OLD FEMALE ADMITTED TO SAME DAY SURGERY FOR LAPAROSCOPIC PROCEDURE FOR PROBABLE L TUBAL PREGNANCY. TROCAR ALLEGEDLY FAILED TO RETRACT. RT ILIAC ARTERY PUNCTURED. PT OPENED FOR EXPLORATORY LAP, ARTERY REPAIRED. PT ADMITTED 8/22, DISCHARGED 8/24/96, NO FURTHER COMPLICATIONS.
INTRA-AORTIC BALLOON CATHETER INSERTED 8/13/96. ON 8/15/96, THE BALLOON PUMP BEGAN TO ALARM SENDING THE MESSAGE "HI-LEAK." BLOOD WAS OBSERVED IN THE BALLOON LINE. THE PUMP WAS STOPPED AND THE PHYSICIAN REMOVED THE CATHETER.
THE CATH LAB MGR REPORTED THAT THE DEVICE WAS INSERTED INTO A 57 YEAR OLD MALE PT AND IT WAS PLACED UP AND AROUND THE AORTIC ARCH. THE PHYSICIAN ATTEMPTED TO SEAT THE DEVICE IN THE ARTERY, BUT IT FOLDED OVER ON ITSELF. THE PHYSICIAN TRIED TO PLACE A .035J WIRE THROUGH THE DEVICE BUT WAS UNSUCCESSFULL. HE THEN ATTEMPTED TO PLACE A .063 WIRE THROUGH THE DEVICE AND THEN THE END OF THE DEVICE BROKE OFF IN THE PT. THE PHYSICIAN SNARED THE END OF THE BROKEN PIECE OF THE DEVICE AND BROUGHT IT DOWN TO THE FEMORAL ARTERY. THE PT WAS THEN BROUGHT TO SURGERY FOR EXTRICATION OF THE PIECE OF THE DEVICE AND BYPASS SURGERY. THE PT WAS REPORTED AS HAVING AN UNEVENTFUL RECOVERY AFTER SURGERY.
PT COUGHED UP A PIECE OF HARD PLASTIC. SHE STATES THAT WHILE DOING INCENTIVE SPIROMETRY, A PIECE OF PLASTIC WENT INTO HER CHEST AND SHE COUGHED IT OUT. UNSURE IF ALL PIECES OF PLASTIC WERE EXPELLED.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THAT J STIFFENER WIRE HAS FRACTURED AT WELD SITE AND APPROX. 15MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 72MM AND WAS RECEIVED WITH 21MM OF THE DISTAL END PROTRUDING OUT OF THE OUTER POLYURETHANE INSULATION 15MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE LENGTH OF THE J STIFFENER WIRE WAS RECEIVED WITH RECORDED MEASUREMENTS ADDING UP TO 87MM.
PT'S HUSBAND WAS DRAWING UP INSULIN WHEN NEEDLE BROKE OFF INTO INSULIN BOTTLE. STATES THIS WAS THE SECOND ONE OUT OF THIS BOX.
THE FILTER HEATER WAS NOT WORKING. THE CUSTOMER SUPPORT ENGINEER VERIFIED THAT THE HEATER WAS INOPERABLE. THE CSE INSPECTED THE DEVICE AND FOUND THAT THE HEATER RECEPTACLE WAS IMPROPERLY REASSEMBLED BY THE CUSTOMER. THE CSE REINSTALLED THE FILTER HEATER RECEPTACLE. THE UNIT PASSED EXTENDED SELF TESTING.
IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
A 49-YR-OLD FEMALE HAD BILATERAL BREAST SURGERY WITH SILICONE GEL IMPLANTATIONS ABOUT 19 YEARS AGO AT ANOTHER FACILITY. SINCE THEN SHE HAS HAD INCREASING PROBLEMS WITH INTERTRIGO WHICH HAS BEEN RESISTENT TO TREATMENT. SHE SUFFERS SEVERE DEPRESSION AND DEBILITATING PAIN AND DISCOMFORT. IT IS FELT THAT REMOVAL OF THE AREAS OF INTERTRIGO WOULD BENEFIT HER. GROSS EXAM: RIGHT IMPLANT SHOWS NO SIGN OF RUPTURE OR LEAKAGE. MARKED "2206" AND WEIGHED 204 GM. THE LEFT IMPLANT INSIDE THE CAPSULE WAS MASSIVELY DISRUPTED AND EXUDED STICKY, STRINGY VISCOUS GELATINOUS MATERIAL. THE DISRUPTED IMPLANT WEIGHED 198 GM.
SERIOUS INJURY INVOLVING ONE PERSON. PT SLEPT WITH LENSES IN EYES AND THE NEXT MORNING UPON WAKING PT'S EYE WAS DRY AND BECAME RED, IRRITATED AND LIGHT SENSITIVE WHEN REMOVING LENS. THIS WAS A SATURDAY, ON MONDAY SHE WENT TO DR. DR PRESCRIBED ANTIBIOTIC DROPS, TUESDAY DR DIAGNOSED CORNEAL ULCER AND SENT HER TO AN OD DR. LENS MODEL/WATER CONTENT/55%. LOT# UNK; EYE INVOLVED: LEFT; REFRACTION: MYOPIA, TOTAL DURATION FO USE(MONTHS): 1: NUMBER OF DAYS LENS WORN: NEVER; LAST VISIT TO DR PRIOR TO SYMPTOMS: 8/95; TYPE LENS CARE SYSTEM USED: NONE; DISINFECTION SYSTEM USED: NONE; HOMEMADE SALINE USED: NO; NUMBER DAYS WORN BETWEEN CLEANING AN SYMPTONS: IMMEDIATE; DAYS BETWEEN CLEANING AND DISINFECTING-NONE; DAYS WORN BETWEEN SYMPTOMS AND CALLING DR: 1; SELF TREATMENT BY PT: YES, TEARS; HAND WASHING BEFORE LENS MANIPULATION: YES, ULCER LOCATION: 9 O"CLOCK; VISUAL ACUITY BEFORE SYMPTOMS: 20/20; VISUAL ACUITY AFTER SYMPTOMS: GREATER THAN 20/800; RESULTS OF CULTURE: PSEUDOMONAS; RESULTS OF CORNEAL BIOPSY AND/OR SCRAPINGS: NONE TAKEN; CLINICAL DIAGNOSIS: PSEUDOMONAS CORNEAL ULCER SECONDARY TO CONTACT LENS WEAR; TREATMENT ADMINISTERED: FORTIFIED TOBRAMYCIN AND FORTIFIED CILOXAN;
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OCCURRING MORE FREQUENT THAN USUAL? NO. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO.
A 49-YR-OLD FEMALE UNDERWENT BREAST REDUCTION AND SILICONE GEL IMPLANTATION FOR POLANDS DISEASE IN 1972 AT ANOTHER FACILITY. A RECENT MAMMOGRAM REVEALED A "BULDGE" IN THE LEFT BREAST. THE LEFT BREAST HAS AN IRREGULAR SHAPE AND IS TENDER. GROSS EXAM: UNDER PRESSURE, THE LEFT IMPLANT EXUDES STICKY, VISCOUS GELATINOUS MATERIAL THRU A 0.2 CM. AREA OF FENESTRATION AT THE APPARENT APEX OF THE IMPLANT.
THE VENT WOULD NOT PASS THE EXTENDED SELF TEST. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND REPLACED THE FILTER HEATER ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE FILTER HEATER CAUSED THE REPORTED PROBLEM, AND NO MALFUNCTION MAY HAVE OCCURRED.
IT IS UNKNOWN WHETHER THIS EVENT. HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
DURING A ROUTINE PHACOEMULSIFICATION PROCEDURE, THE DR REPORTED OBSERVING PARTICLES DELIVERED INTO THE PT'S EYE. MOST OF THE PARTICLES WERE REMOVED AND THERE WAS NO HARM TO THE PT.
EXFOLIATION TESTS PERFORMED. THE HANDPIECE WAS TESTED FOR PARTICULATE EXFOLIATION AND THE RESULTS INDICATED THAT THE PRODUCT WAS WITHIN THE SPEC. IN ADDITION, EXAM OF THE TIP OF THE NEEDLE REVEALED EVIDENCE OF A 2ND INSTRUMENT COMING IN CONTACT WITH THE TIP DURING THE ULTRASOUND OPERATION.
DEVICE WAS USED DURING A LAPAROSCOPICALLY VAGINAL HYSTERECTOMY. VISIBILITY WAS REPORTEDLY COMPROMISED DURING THE PROCEDURE RESULTING IN LACERATION OF THE BLADDER BY AN UNSPECIFIED DEVICE. A FORMAL LAPAROTOMY WAS PERFORMED AND THE LACERATION WAS REPAIRED. HOSP REPORTEED PT'S STATUS IS SATISFACTORY.
E.4. INITIAL REPORTER (DISTRIBUTOR, MISTAKENLY IDENTIFIED AS MFR) FILED REPORT NUMBER M756802. H.3. LENS APPEARED ETCHED; ALL OTHER ASPECTS OF THE RETURNED PRODUCT WERE WITHIN SPECIFICATION. H.6. EVALUATION CODE 84 -EXCEPT FOR TESTS WHICH COULD NOT BE CONDUCTED BECAUSE OF CONDITION OF RETURNED PRODUCT. H.6. EVALUATION CODE 61 -LABELING INSTRUCTIONS INDICATE THE LAPAROSCOPE SHOULD BE EVALUATED PRIOR TO EACH USE TO INSURE ADEQUATE OPTICAL PERFORMANCE.
THIS 58-YR-OLD FEMALE UNDERWENT BAM MANY YEARS AGO USING SILICONE GEL IMPLANTS. THIS PROCEDURE WAS PERFORMED AT ANOTHER FACILITY AND THE MFR IS UNKNOWN TO THIS REPORTING FACILITY. THE PT DID NOT GIVE A DATE OF EXACT IMPLANTATION. THE PT COMPLAINS OF PAIN ON THE LEFT SIDE DUE IN PART TO THE IMPLANT BECOMING ENTRAPPED LATERALLY WITH A BAND OF SCAR TISSUE ALONG THE INCISION LINE. GROSS EXAM: THE LEFT IMPLANT WAS COMPLETELY DISRUPTED IN THE CAPSULE.
THE VENTILATOR WOULD NOT PASS THE EXTENDED SELF TEST. THE CUSTOMER SUPPORT ENGINEER WAS INSPECTING THE VENTILATOR AND NOTICED THERE WAS NO AUDIO ALARM, THE CSE REPLACED THE ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING.
IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
ADD'L INFO SUBMITTED? NO. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OCURRING MORE FREQUENTLY THAN USUAL? NO. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO.
SECTION B5-VISUAL ACUITY BEFORE SYMPTOMS: 20/40. RESULTS OF CULTURE: UNK; RESULTS OF CORNEAL BIOPSY AND OR SCRAPINGS:UNK;
DURING CRANIOTOMY, DRILL BIT BROKE IN BONE OF PT. PORTION REMAINS IN PT. DR NOT CONCERNED REGARGING PORTION STILL IN PT.
SYNTHES IS SUBMITTING THIS REPORT PERSUANT TO THE PROVISION OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFO WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR IT'S EMPLOYEES. THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.
THE DEVICE ANALOG METER READS NEGATIVE PRESSURE DURING A NORMAL POSITIVE PRESSURE CONDITION. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE, BUT COULD NOT DUPLICATE THE REPORTED CONDITION AND REPLACED THE AUTOZERO SOLENOIDS AS A PRECAUTION. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE DEVICE PRESSURE READINGS ARE OUT OF SPEC, AND NO MALFUNCTION MAY HAVE OCCURRED.
A PT WHOSE INR IS USUALLY 4.0, WAS FOUND TO BE 7.6, 5.5 AND 4.1 WITH NEW STRIPS LOTS AND OLD CONVERSION CHART. WHEN THE CORRECT CONVERSION CHART WAS USED, VALUES OF 5.1, 4.0 AND 3.24 WERE OBTAINED.
THE INITIAL MANUFACTURER'S REPORT 1823260-1996-00085 INDICATED INCORRECTLY IN BLOCK B1 THAT THE REPORT INOVLVED AN ADVERSE EVENT. THE EVENT INVOLVED A PRODUCT PROBLEM. FOR THIS REASON, THE PT INFO IS NOT APPLICABLE (NA). NO ADVERSE EFFECT TO ANY PT WAS NOTED. NO MEDICATION OR MEDICAL TREATMENT WAS GIVEN BASED ON THE PRODUCT MALFUNCTION. THIS INFO WAS NOT RECEIVED BY CO FROM A USER FACILITY REPORT. CO IS THE MANUFACTURER OF THE DEVICE, NOT THE USER FACILITY. THUS BLOCK F IS NOT
THE DEVICE DID NOT DELIVER SET VOLUME. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND DID NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED TESTING. THE CSE REPLACED THE OUTLET CHECK VALVE, PT CONNECTOR AND ADJUSTED THE ANALOG METER. IT IS NOT VERIFIED THERE WAS A VOLUME LOSS, AND NO MALFUNCTION MAY HAVE OCCURRED.
WHILE PLACING THE AORTIC VALVE, A LEAFLET BROKE DURING SUTURING. THE VALVE WAS EXPLANTED AND REPLACED. THE PT EXPIRED POSTOPERATIVELY DUE TO OTHER HEALTH PROBLEMS. NO INFO HAS BEEN RECEIVED TO INDICATE THE DEATH IS VALVE RELATED.
INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH CO SPECIFICATIONS AT THE TIME OF MFR. THE CO PHYSICIAN'S MANUAL CAUTIONS AGAINST APPLYING FORCE TO THE LEAFLETS, AS THIS COULD RESULT IN STRUCTURAL DAMAGE TO THE VALVE. THE FRACTURE DAMAGE WAS MOST LIKELY CAUSED INTRAOPERATIVELY, AND WAS NOT DUE TO AN INTRINSIC DEFECT IN THE VALVE. CO DIV. HAS RECEIVED NO ADDITIONAL INFORMATION, SUCH AS THE OPERATIVE REPORT, WHICH MAY HAVE AIDED IN THE EVALUATION OF THIS VALVE. PAGES = 2.
THE PRODUCT WAS APPLIED IN AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER PRODUCT. THE HOSP HAS REORTED NO PT INJURY OCCURRED.
THE DEVICE AUDIBLE ALARM WAS NONFUNCTIONAL. THE CUSTOMER SUPPORT ENGINEER VERIFIED THE NON ALARM CONDITION AND TIGHTENED ALL ALARM CONNECTIONS. THE UNIT PASSED EXTENDED SELF TESTING.
THE CATHETER WAS BEING UTILIZED FOR AN ANGIOGRAPHIC PROCEDURE. THE PROCEDURE WAS COMPLETED AND THE CATHETER WAS REMOVED. UPON REMOVAL, IT WAS NOTED THE TIP WAS MISSING FROM THE CATHETER. THE SEPERATED CATHETER TIP WAS NOTED TO BE STICKING OUT AT THE GROIN SITE. THE SEPARATED SEGMENT WAS GRASPED AND REMOVED BY HAND. WHILE NO SERIOUS ILLNESS OR INJURY OCCURRED, INTERVENTION WAS REQUIRED TO PREVENT PT IMPACT.
THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED FOR EVAL. HOWEVER, AN EVAL OF A CATHETER FROM THE SAME LOT REVEALED SIMILAR CHARACTERISTICS WHICH MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. CO CAN ADVISE THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS MATTER AND HAVE TAKEN THE NECESSARY CORRECTIVE ACTION TO ASSURE THIS SITUATION DOES NOT RECUR.
DEVICE WAS USED DURING A TOTAL GASTRECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SUTURE BROKE DURING USE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED NO PT INJURY.
THE CUSTOMER ALLEGED THE AUDIBLE ALARM TO BE INTERMITTENT. THE SUPPORT ENGINEER INSPECTED THE DEVICE AND COULD NOT VERIFY THE REPORTED EVENT. THE CSE REPLACED THE POWER SWITCH AS A PRECAUTION. THE UNIT PASSED EXTENDED SELF TESTING.
PT RECEIVED BREAST IMPLANTS ON 10/6/87. PT ALLEGES DEVELOPING HARDNESS OF THE LEFT BREAST IN APPROX 1/96. PHYSICIAN STATED THE PT DEVELOPED LEFT BREAST CAPSULE FORMATION AND RUPTURE OF LEFT AND RIGHT IMPLANTS.
CONCLUSION: 68 OTHER (NO DEVICE RETUNED). THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED TO 21 CFR, PART 803. THE REPORT TRANSMITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OR OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AN ANY ALLEGED INJURY.
DEVICE WAS BEING UTILIZED ON A SIXTY-SEVEN YR OLD MALE PT. UPON ATTEMPTED REMOVAL OF THE CATHETER, THE MARKER BANDS SLIPPED OFF, REMAINING IN THE COMMON FEMORAL ARTERY. THE PHYSICIAN MANEUVERED THE BANDS TO THE ILIOLUMBAR ARTERY, WHERE THEY REMAINED. NO ATTEMPT TO RETRIEVE THE BANDS WAS MADE. THE PHYSICIAN DOES NOT FEEL THE BANDS PRESENT A RISK TO THE PT.
THE RETURNED CATHETER APPEARS TO HAVE BEEN MANUFACTURED ACCORDING TO SPECIFICATIONS. HOWEVER, CO DOES CONFIRM THAT THE MARKERS ARE NO LONGER PRESENT ON THE CATHETER SHAFT. IT WAS ALSO NOTED THAT THE SIDEPORT HOLES HAVE BECOME OVAL AND THE CATHETER MATERIAL AT THE PROXIMAL END OF THE SIDEPORT HOLES HAS SCRAPED BACK. UNFORTUNATELY, FROM THE AVAILABLE INFO, CO IS UNABLE TO DETERMINE WHY THE MARKERS MAY HAVE SLIPPED OFF THE CATHETER. CO CAN ADVISE THE MARKERS ARE INSPECTED 100% IN QUALITY CONTROL TO ASSURE SECURITY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS MATTER.
THE SHEATH WAS PLACED IN THE RIGHT FEMORAL VEIN FOR A CARDIAC CATHETERIZATION PROCEDURE. A CATHETER WAS PLACED THROUGH THE SHEATH AND REPOSITIONING REQUIRED PULLING THE CATHETER BACK THROUGH THE SHEATH. DURING MANIPULATION THE SHEATH SHEARED AND A PORTION OF THE SHEATH REMAINED IN THE FEMORAL VEIN. THE DETACHED SEGMENT OF SHEATH LODGED IN THE LEFT PULMONARY ARTERY AND WAS RETRIEVED UNDER FLUOROSCOPY IN THE SPECIAL PROCEDURES DEPT. THE PT WAS SUBSEQUENTLY ADMITTED FOR OBSERVATION. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.
THE DEVICE WOULD NOT HOLD PEEP. THE CUSTOMER SUPPORT ENGINEER VERIFIED  A PEEP LEAK. THE INSPECTED THE DEVICE AND REPLACED THE AUTOZERO SOLENOID. THE UNIT PASSED EXTENDED SELF TESTING.
IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREWATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE SYSTEM WAS EXPLANTED DUE TO EROSION. EXACT EVENT DATE IS UNKNOWN.
REFERENCE SECTION F.10 OF THIS FORM FORM FOR EVENT PROBLEM CODES.
PT RECEIVED A BREAST IMPLANT IN 1987, AND OF AN UNK MFR. REPORT ALLEGES PT SENT IN A CHEMICAL TEST RESULT WHICH SHOWED A CHEMICAL IN HER SYSTEM THAT WAS FROM THE IMPLANT. PT HAD REMOVAL IN 1992.
CONCLUSION: 68 OTHER (NO DEVICE RETURNED). THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED PURSUANT TO 21 CFR, PART 803. THE REPORT TRANSMITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
DEVICE WAS BEING UTILIZED ON A PT TO TREAT A G.I. BLEEDER IN THE INFERIOR MESENTERIC ARTERY. UPON INTRODUCTION OF AN EXCHANGE WIRE GUIDE, THE TIP OF THE CATHETER SEPARATED. THE TIP REMAINED IN THE PT. THE PHYSICIAN FELT THE TIP DID NOT PRESENT ANY DANGER TO THE PT AND NO ATTEMPT TO RETRIEVE THE SEPARATED SEGMENT WAS MADE.
THE PRODUCT WAS RETURNED IN AN OPEN AND USED CONDITION. CO RECEIVED THE HNBR5.0 CATHETER FROM THE CUSTOMER BUT THE SEPARATED DISTAL TIP WAS NOT RETURNED. THE TIP SEPARATED FROM THE CATHETER AND LEFT APPROX. 5MM OF BONDED MATERIAL ON THE MAIN CATHETER BODY. CO CAN ADVISE THE CUSTOMER THAT THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND ARE CURRENTLY INVESTIGATING THIS MATTER TO ASSURE THIS SITUATION DOES NOT RECUR.
THE ORIGINAL PROCEDURE WAS A SMALL MESENTERIC ANGIOGRAM. THE WIRE WAS USED THROUGH AN ENTRY NEEDLE. THE WIRE WAS REMOVED AND IT WAS NOTED APPROX 13CM OF THE COATING SHEARED AND DETACHED IN THE PT'S RIGHT GROIN. SURGICAL REMOVAL OF THE DETACHED COATING WAS UNEVENTFUL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DIRECTIONS FOR USE FOR THIS PRODUCT STATE: "TO AVOID DAMAGE AND POSSIBLE SHEARING OF PLASTIC, DO NOT WITHDRAW OR MANIPULATE THROUGH A METAL CANNULA/METAL DILATOR NOR ADVANCE THE METAL CANNULA/METAL DILATOR. EXTREME CAUTION SHOULD BE OBSERVED WHEN USED WITH A ONEWALL PUNCTURE STYLE NEEDLE."
THE SVC REPORT SHOWS THAT WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE UNIT, THE CUSTOMER SUPPORT ENGINEER NOTED THAT THE PITCH OF THE AUDIO ALARM WAS LOW. THE INSPECTED THE DEVICE AND REPLACED THE AUDIO ALARM AS A PRECAUTION. THE UNIT PASSED EXTENDED SELF TESTING.
FOUR FEMALES AND ONE MALE EXPERIENCED SKIN IRRITATIONS WHILE WEARING LATEX EXAM GLOVES. ONE FEMALE WITH HISTORY OF REACTIONS REQUIRED PRESCRIPTION HAND CREAM. THE OTHER FOUR DID NOT NEED ANY MEDICAL TREATMENT. THE MFR OF THE GLOVES IS UNKNOWN DUE TO LOT NUMBER IS UNAVAILABLE.
H3 - DEVICES WERE RETURNED TO DOW CORNING FOR ID PURPOSES ONLY AND RETURNED TO A FACILITY WITHOUT FURTHER EVALUATION.
REPORT ALLEGES PATIETN RECEIVED IMPLANTS ON MARCH 31, 1977. PHYSICIAN'S CONSULTATION NOTES SHOW THAT PATIENT WAS HOSPITALIZED IN AUGUST 1987 FOR EVALUATION OF WEAKNESS AND A DIAGNOSIS OF MAJOR DEPRESSIVE EPISODES WAS MADE. SHE WAS ALSO HOSPITALIZED IN AUGUST 1988 FOR EVALUATION OF SEVERE EPIGASTRIC PAIN WHICH IS PROBABLY OF MUSCULAR ORIGIN. SHE HAS KNOWN DEGENERATIVE JOINT DISEASE OF THE CERVICAL SPINE AND HIP. CLINICAL NOTES OF OCT. 13, 1989 SHOWS PATIENT COMPLAINS OF PAIN OF HER RIGHT AND LEFT TEMPOROMANDIBULAR JOINT AND NOTES OF SEPT. 10, 1992 SHOW SHE HAS A PERSISTENT PRURITIC SPREADING RASH. PATIENT HAD REMOVAL AND REPLACEMENT OF BOTH IMPLANTS ON JAN. 28, 1993 WITH SALINE DEVICES OF ANOTHER MFR, DUE TO RUPTURE AND LEAKAGE.
REPORT ALLEGES PATIENT RECEIVED IMPLANTS ON MARCH 31, 1977. PHYSICIAN'S CONSULTATION NOTES SHOW THAT PATIENT WAS HOSPITALIZED IN AUG. 1987 FOR EVALUATION OF WEAKNESS AND A DIAGNOSIS OF MAJOR DEPRESSIVE EPISODES WAS MADE. SHE WAS ALSO HOSPITALIZED IN AUG. 1988 FOR EVALUATION OF SEVERE EPIGASTRIC PAIN WHICH IS PROBABLY OF MUSCULAR ORIGIN. SHE HAS KNOWN DEGENERATIVE JOINT DISEASE OF THE CERVICAL SPINE AND HIP. CLINICAL NOTES OF OCT. 13, 1989 SHOWS PATIENT COMPLAINS OF PAIN OF HER RIGHT AND LEFT TEMPOROMANDIBULAR JOINT AND NOTES OF SEPT. 10, 1992 SHOW SHE HAS A PERSISTENT PRURITIC SPREADING RASH. PATIENT HAD REMOVAL AND REPLACEMENT OF BOTH IMPLANTS ON JAN. 28, 1993 WITH SALINE DEVICES OF ANOTHER MFR, DUE TO RUPTURE AND LEAKAGE.
THE CUSTOMER ALLEGED THE AUDIBLE ALARM WAS INTERMITTENT. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE CSE REPLACED THE AUDIBLE ALARM ASSEMBLY AS A PRECAUTION. IT IS NOT VERIFIED THAT ALARM FAILED TO FUNCTION, AND NO MALFUNCTION MAY HAVE OCCURRED.
CATHETER WAS INSERTED IN TC ON 2/27/96. IT WAS REMOVED ON 3/1/96 DUE TO SECOND DEGREE INFILTRATION. PT WAS NOTED TO BE LETHARGIC ON 3/3/96 WITH LUNG CONGESTION AND TACHYCARDIA. IV SITE WAS LEAKING BROWN PURULENT DRAINGE. ON 3/4/96 MD IDENTIFIED SEPSIS NAD STARTED TREATMENT WITH CEFTRAXONE.
THE SVC REPORT SHOWS THE CUSTOMER REPORTED THE DEVICE AUDIO ALARM DID NOT SOUND WHEN A PT BECAME DISCONNECTED DURING A CAT SCAN PROCEDURE. THE CUSTOMER SUPPORT ENGINEER VERIFIED A VISUAL ALARM AND NO AUDIBLE ALARM SOUND. THE CSE INSPECTED THE DEVICE AND REPLACED THE AUDIO ALARM. THE UNIT PASSED EXTENDED SELF TESTING.
PT RECEIVED BREAST IMPLANT ON AN UNK DATE AND THE IMPLANT HAS RUPTURED.
CONCLUSION: 68 OTHER (NO DEVICE RETURNED). THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED PURSUANT TO 21 CFR, PART 803. THE REPORT TRANSMITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OR OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
R GROIN CATHETER WAS NOT OCCLUDED. THE CATHETER AND SHEATH HAD MIGRATED OUT OF THE VESSEL WHILE DELIVERING UROKINASE, LG HEMATOMA DEVELOPED. MD INSTRUCTED NURSE TO PULL BACK CATHETER HOPING TO BETTER POSITION THE CATHETER. HOWEVER, CATHETER WAS OUT OF THE VESSEL, WAS REMOVED, AND A NEW CATHETER PLACED.
REFERENCE MFR COMPLAINT #Z96-321. NO SAMPLES WERE RETURNED FOR EVALUATION. CLIPS FROM THE COMPLAINT LOT WERE EVALUATED FOR LIGATING EFFICACY IN A CANINE MODEL. RESULTS INDICATE THAT HEMOSTASIS WAS OBTAINED INTRAOPERATIVELY AND AT SEVEN DAYS POST-OPERATIVELY. IN AN EARLIER STUDY USING A PORCINE MODEL THE CLIPS WERE USED TO LIGATE THE CYSTIC DUCT AND ARTERY. POST MORTEM EVALUATION OF THE LIGATED SITES INDICATED THE CYSTIC DUCT HAD MACROSCOPIC EVIDENCE OF HEALING AT SEVEN DAYS. THERE WAS NO EVIDENCE OF NECROSIS AT ANY SITE. A REVIEW OF THE LOT HISTORY WAS UNREMARKABLE AND THERE HAVE BEEN NO OTHER COMPLAINTS AGAINST THIS LOT. ON THE BASIS OF THE TEST RESULTS AND INVESTIGATION, THE CLIPS SHOULD HAVE PERFORMED SATISFACTORILY  UNDER NORMAL CONDITIONS OF USE. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUR INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
REFERENCE MFR. COMPLAINT #Z96-321. INITIAL REPORT IDENTIFIED "PRODUCT PROBLEM"; HOWEVER, CO IS UNABLE TO DETERMINE IF THE REPORTED EVENT WAS DUE TO A PRODUCT PROBLEM OR SOME OTHER EVENT. THEREFORE, CO IS REPORTING AS AN "ADVERSE EVENT". SECTION F-10 WAS ALSO CHANGED FROM DEVICE CODE 1379 = FAILURE TO MAINTAIN, TO 2204 = UNK. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS USED FOR LIGATION OF THE CYSTIC DUCT. POSTOPERATIVELY THE PT DEVELOPED BILE LEAKAGE AND A COLLECTION OF BILE OCCURRED IN THE LIVER BED. THE BILE WAS ASPIRATED ENDOSCOPICALLY AND THE PT HAD NO FURTHER COMPLICATIONS.
THE DEVICE WAS USED DURING A OOPHOROCYSTECTOMY PROCEDURE. REPORTEDLY, THE SAFETY SHIELD DID NOT RETRACT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. THE SURGEON COMPLETED THE PROCEDURE WITH A NEW INSTRUMENT.
68 OTHER (NO DEVICE RETURNED). THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED TO 21 CFR, PART 803. THE REPORT TRANSMITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OR OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
A #22 CATHETER WAS STARTED ON 2/15 AND REMOVED ON 2/18 DUE TO SECOND DEGREE INFILTRATION AND LEAKING. ON 2/19 TEMP TO 101 DEGREES. DR PERFORMED I & D ON OLD IV SITE. PT WAS TREATED WITH DRESSING CHANGES AND ORAL ANTIBIOTIC.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE WAS USED FOR LIGATION OF THE CYSTIC DUCT. BETWEEN THE SECOND AND THE SEVENTH POSTOPERATIVE DAYS, AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WAS PERFORMED TO OBSERVE THE DUCTAL SYSTEM. SUBSEQUENTLY, THE PT DEVELOPED BILE PERITONITIS AND REQUIRED FURTHER SURGERY. DURING RE-EXPLORATION, IT WAS NOTED THAT THE DEVICE HAD DISLODGED FROM THE CYSTIC DUCT.
REFERENCE MFR. COMPLAINT #Z96-321(1). NO SAMPLES WERE RETURNED FOR EVALUATION. CLIPS FROM THE COMPLAINT LOT WERE EVALUATED FOR LIGATING EFFICACY IN A CANINE MODEL. RESULTS INDICATE THAT HEMOSTASIS WAS OBTAINED INTRAOPERATIVELY AND AT SEVEN DAYS POST-OPERATIVELY. IN AN EARLIER STUDY USING A PORCINE MODEL THE CLIPS WERE USED TO LIGATE THE CYSTIC DUCT AND ARTERY. POST MORTEM EVALUATION OF THE LIGATED SITES INDICATED THE CYSTIC DUCT HAD MACROSCOPIC EVIDENCE OF HEALING AT SEVEN DAYS. THERE WAS NO EVIDENCE OF NECROSIS AT ANY SITE. A REVIEW OF THE LOT HISTORY WAS UNREMARKABLE AND THERE HAVE BEEN NO OTHER COMPLAINTS AGAINST THIS LOT. ON THE BASIS OF THE TEST RESULTS AND INVESTIGATION, THESE CLIPS SHOULD HAVE PERFORMED SATISFACTORILY UNDER NORMAL CONDITIONS OF USE. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETED AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUR INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE VENTILATOR WOULD AUTOCYCLE WHEN SENSITIVITY WAS SET TO 20. IT IS NOT VERIFIED THAT THE DEVICE/COMPONENT DID NOT FUNCTION TO SPEC, AND NO MALFUNCTION MAY HAVE OCCURRED. THE AUTO ZERO SOLENOID WAS REPLACED AS A PRECAUTION.
PHYSICIAN PERFORMED LAPAROSCOPIC L. HERNIORRAPHY. TWO STAPLES BOTH FAILED TO PERFORM AS DESIGNED. STAPLER EJECTED THE STAPLES BEFORE THE STAPLER CLOSED. A DIFFERENT BRAND OF STAPLER WAS USED TO ACCOMPLISH CLOSURE BUT THE UMBILICAL TROCAR SITE HAD TO BE ENLARGED TO ACCOMMODATE THE STAPLER.
PT RECEIVED BREAST IMPLANTS IN 1976. PT ALLEGES HAVING LEAKAGE.
68 OTHER (NO DEVICE RETURNED). THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED PURSUANT TO 21 CFR, PART 803. THE REPORT TRANSMITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OF OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
THE PRODUCT WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE SCOPE VISION WAS NOT CLEAR. THE SURGEON APPLIED ANOTHER DEVICE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
DURING A LAPOROSCOPIC CHOLECYSTECTOMY, THE DEVICE WAS USED FOR LIGATION. BETWEEN THE SECOND AND THE SEVENTH POSTOPERATIVE DAYS, AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WAS PERFORMED TO OBSERVE THE DUCTAL SYSTEM. SUBSEQUENTLY, THE PT DEVELOPED CYSTIC DUCT LEAKAGE. THE BILE WAS ASPIRATED ENDOSOPICALLY, AND NO FURTHER PT COMPLICATION HAS BEEN REPORTED.
REFERENCE MFR. COMPLAINT #Z96-321(2). NO SAMPLES WERE RETURNED FOR EVALUATION. CLIPS FROM THE COMPLAINT LOT WERE EVALUATED FOR LIGATING EFFICACY IN A CANINE MODEL. RESULTS INDICATE THAT HEMOSTASIS WAS OBTAINED INTRAOPERATIVESLY AND AT SEVEN DAYS POST-OPERATIVELY. IN AN EARLIER STUDY USING A PROCINE MODEL THE CLIPS WERE USED TO LIGATE THE CYSTIC DUCT AND ARTERY. POST MORTEM EVALUATION OF THE LIGATED SITES INDICATED THE CYSTIC DUCT HAD MACROSCOPIC EVIDENCE OF HEALING AT SEVEN DAYS. THERE WAS NO EVIDENCE OF NECROSIS AT ANY SITE. A REVIEW OF THE LOT HISTORY WAS UNREMARKABLE AND THERE HAVE BEEN NO OTHER COMPLAINTS AGAINST THIS LOT. ON THE BASIS OF THE TEST RESULTS AND INVESTIGATION, THE CLIPS SHOULD HAVE PERFORMED SATISFACTORILY UNDER NORMAL CONDITIONS OF USE. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
CATHETER INFECTED AND REMOVED AT DR'S OFFICE. DR'S NURSE REPORTED THAT THE CUFF WAS DISINTEGRATED AND NOT ABLE TO BE REMOVED AT OFFICE. USUAL REMOVAL INVOLVES MAKING AN INCISION TO PULL THE CATHETER AND THIS WAS DONE. HOWEVER, THE CUFF DID NOT COME OUT AT OFFICE AND WAS REMOVED IN OR. PT COMFORT WAS BETTER IN OR. ANOTHER PORT INSERTED ON 2/19 FOR VENOUS ACCESS. PHYSICIAN ALSO EXPLORED PREVIOUS SITE AND REMOVED NECROTIC MATERIAL, PUS AND THE CUFF FORM THE CATHETER.
PT RECEIVED BREAST IMPLANTS ON AN UNK DATE AND THEY ARE DEFECTIVE.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT LEAKED AT THE SEAL AND BROKE. THE SURGEON APPLIED ANOTHER DEVICE. THE HOSP HAS REPORTED NO PT INJURY.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT LEAKED GAS AND BROKE. THE SURGEON USED ANOTHER INSTRUMENT. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
PT RECEIVED BREAST IMPLANTS ON AN UNK DATE AND OF AN UNK MFR. PT IS VERY NERVOUS.
CONCLUSION: 68 OTHER (NO DEVICE RETURNED). THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED PURSUANT TO 21 CGFR, PART 803. THE REPORT TRANSMITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OR OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
THE DEVICE AUDIBLE ALARM VOLUME SOUNDS LOW. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND REPLACED THE AUDIO ALARM. THE UNIT PASSED EXTEDNDED SELF TESTING. IT IS NOT VERIFIED THAT THE ALARM VOLUME IS OUT OF SPECIFICATION AND NO MALFUNCTION MAY HAVE OCCURRED.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION ON OR ABOUT 217/83. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, FATIGUE, JOINT PAIN, AND SWOLLEN LYMPH NODES.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION ON 2/21/84 WIHT EXPLANT ON 1/23/96. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, RASH, FEVER, JOINT PAIN AND MEMORY LOSS.
NO PRODUCT IDENTIFICATION IS GIVEN, MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO HAS NOT SOLD THIS PRODUCT SINCE 1984.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT LOAD PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
PT RECIEVED BREAST IMPLANTS ON 2/8/80. DESCRIPTION OF ALLEGATIONS: PAIN, LUMP, BROKEN PROSTHESIS IN 9/95. PT HAD REMOVAL AND REPLACEMENT ON 12/7/95 WITH SALINE DEVICES OF ANOTHER MFR. INVESTIGATIVE FINDINGS: PHYSICIAN STATED BREAST IMPLANTS WERE REMOVED FROM THIS PT IN 12/7/95. RIGHT PROSTHESIS WAS RUPTURED COMPLETELY. LEFT PROBABLY RUPTURED PRIOR TO SURGERY BUT VERY HARD, FULLY RUPTURED ON REMOVAL.
CONCLUSION: 68 OTHER (NO DEVICE RETURNED). THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED PURSUANT 21 CFR, PART 803. THE REPORT TRANSMNITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OR OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
THE SVC REPORT SHOWS THE DEVICE FAILED LEAK TESTING. THE SVC TECHNICIAN VERIFIED THE LEAK AND CLEANED THE PUMP ASSEMBLY. THE UNIT PASSED EXTENDED TESTING.
IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL THE THE DEVICE.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP DID NOT FORM PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. THE SURGEON APPLIED ANOTHER INSTRUMENT.
9/24/96-CORRECTED INFORMATION SUBMITTED FOR B-4 AND F-8 ADDITIONAL INFORMATION SUBMITTED FOR D-9. DEVICE EVALUATION INDICATED AND CODES ENTERED FOR H3 AND H-6
LEAD FRACTURE IDENTIFIED WHEN TESTING REVEALED THAT RESISTANCE COULD NOT BE MEASURED. LEAD WAS CAPPED AND NEW VENTRICULAR LEAD WAS PLACED.
FEMORAL COMPONENT WAS REVISED DUE TO A CRACK.
INFO REQUESTED ON 9/30/96. CONCLUSION STATEMENT: AN EVAL HAS DETERMINED THAT THIS SPECIFIC EVENT CAN BE ATTRIBUTED TO A MULTITUDE OF VARIABLES INDEPENDENT OF THE COMPONENT. PRODUCT WAS MFR AND SOLD BY ANOTHER CO, THE ASSESTS OF WHICH WERE PURCHASED BY THIS CO. THREE CONTACTS TO USER FACILITY WERE MADE AND DOCUMENTED REQUESTING MEDWATCH FORM. INFO WAS NOT RECEIVED.
THE SVC REPORT SHOWS THE DEVICE FAILED LEAK TESTING. THE SVC TECHNICIAN VERIFIED THE LEAK AND REPLACED THE SAFETY VALVE SPRING. THE UNIT PASSED EXTENDED TESTING.
H3-THE LEFT DEVICE WAS RETURNED TO DOW CORNING FOR ID PURPOSES ONLY AND UPON VISUAL EXAMINATION THE CONDITION OF THE IMPLANT APPEARED TO BE INTACT WITH UNK SHELL INTEGRITY. THE DEVICE WAS THEN RETURNED TO AUSTRALIA ON AUG. 15, 1996 WITHOUT FURTHER EVALUATION.
REPORT ALLEGES PATIENT BEGAN EXPERIENCING PAIN AND HARDNESS IN APPROX. 1986 AND DISTORTION AND INTRACAPSULAR RUPTURE IN APPROX. 1994.
WHEN HF CURRENT WAS APPLIED DURING A PROSTATE TRANSURETHRAL RESECTION, THE PT'S BODY SPASMED. A CABLE WAS CHANGED, BUT THE PT AGAIN JERKED. WHEN THE CUTTING LOOP ELECTRODE WAS CHANGED, THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER PROBLEMS.
THE DATA IN SECTION F WAS FILLED IN BY THIS MFR.
THE SVC REPORT SHOWS THE HIGH PRESSURE ALARM WAS OUT OF SPEC. THE SVC TECHNICIAN VERIFIED THAT THE ALARM DID NOT ACTIVATE AND ADJUSTED THE HIGH PRESSURE ALARM CIRCUIT. THE UNIT PASSED EXTENDED TESTING.
PT COMPLAINT OF PAIN AN RADIOGRAPH ALLEGEDLY SHOWED PROBABLE PATELLA LOSSENING. REVISION SURGERY PERFORMED. DURING PATELLA REVISION, TIBIAL INSERT WAS CHECKED AND SOME WEAR WAS FOUND. DR. DECIDED TO REPLACE INSERT DURING PATELLA SURGERY. TIBIAL INSERT WAS CUT WITH AN OSTEOTOME FOR EASIER REMOVAL AND REPLACED.
ADDITIONAL INFO REQUESTED 9/30/96. F10 NI; THREE CONTACTS WERE MADE AND DOCUMENTED WITH USER FACILITY REQUESTING ADDITIONAL INFO. USER FACILITY DID NOT SUBMIT MEDWATCH 3500A.
DEVICES WERE RETURNED TO DOW CORNING FOR ID PURPOSES ONLY AND UPON VISUAL EXAMINATION THE UNITS WERE FOUND NOT TO BE INTACT. THE DEVICES WERE RETURNED TO AUSTRALIA WITHOUT FURTHER EVALUATION.
DEVICES WERE RETURNED TO DOW CORNING FOR ID PURPOSES ONLY AND UPON VISUAL EXAMINATION THE UNITS WERE FOUND NOT BE BE INTACT. THE DEVICES WERE RETURNED TO AUSTRALIA WITHOUT FURTHER EVALUATION.
REPORTER ALLEGES PATIENT RECEIVED IMPLANTS ON SEPT. 7, 1983 AND HAD REMOVAL ON JULY 31, 1996. REPORTER ALSO ALLEGES PATIENT HAD ENCAPSULATION IN 1983, OPEN CAPSULOTOMY ON MARCH 8, 1984 AND ON MARCH 10, 1984 SHE HAD ENCAPSULATION AND ONGOING MIRGRATION. PHYSICIAN STATES SEVERE ENCAPULATION AND MIGRATION WITH POSSIBLE SHELL FAILURE IN LEFT SIDE.
REPORTER ALLEGES PATIENT RECEIVED IMPLANTS ON SEPT. 7, 1983 AND HAD REMOVAL ON JULY 31, 1996. REPORTER ALSO ALLEGES PATIENT HAD ENCAPSULATION IN 1983, OPEN CAPSULOTOMY ON MARCH 8, 1984 AND ON MARCH 10, 1984 SHE HAD ENCAPSULATION AND ONGOING MIGRATION. PHYSICIAN STATES SEVERE ENCAPULATION AND MIGRATION WITH POSSIBLE SHELL FAILURE IN LEFT SIDE.
CUSTOMER RECEIVED A CUSTOM KIT IN AN UNSEALED POUCH. THE PRODUCT WAS NOT USED.
THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF NAMIC USA CORP. THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
THE CUSTOMER REPORTED THAT THE VOLUMES CHANGED WITH EACH BREATH. THE SVC TECHNICIAN VERIFIED THAT THE VOLUMES WERE FLUCTUATING AND WERE OUT OF SPEC. THE ST INSPECTED THE DEVICE AND REPLACED THE CUP SEAL AND PRESSURE LIMIT SPRING. THE UNIT PASSED EXTENDED TESTING.
CODE 000: CUP SEAL, SPRING. IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, CLIPS WERE NOT LOADING OR FORMING PROPERLY. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE HOSP HAS REPORTED NO PT INJURY.
THE SVC REPORT SHOWS THAT WHILE PERFORMING AN INCOMING EVAL OF THE DEVICE, THE VOLUMES WERE FOUND TO BE OUT OF SPEC. THE SVC TECHNICIAN INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING.
THE DEVICE WAS APPLIED DURING A BILATERAL VATS LOBECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE STAPLE LINE AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
VENTRICULAR LEAD WILL NOT SENSE OR CAPTURE WELL. LEAD IS MALFUNCTIONING.
THE DEVICE DID NOT DELIVER SET VOLUME. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED TESTING. NO PARTS WERE REPLACED. IT IS NOT VERIFIED THERE WAS A VOLUME LOSS, AND NO MALFUNCTION MAY HAVE OCCURRED.
PHYSICIAN IDENTIFIED BURN AT ENTRY SITE AFTER REMOVING PHACO HANDPIECE AT END OF CATARACT EXTRACTION. SUTURES REQUIRED TO OBTAIN WATER TIGHT SEAL.
CUSTOMER RESPONDED TO PULSELESS NON-BREATHING PT. PT REMAINED ASYSTOLE THROUGHOUT ENTIRE EVENT. A NUMBER OF SHOCKS WERE DELIVERED PRIOR TO CUSTOMER ALLEGING DEVICE DISPLAYED FAULT CONDITION. PT EXPIRED. SVC RESP UNABLE TO DUPLICATE ALLEGED FAULT CONDITION.
SECTION F.10 CODE #1727, #2416, #1802. #1384-NOT LABELED. SVC REP WAS UNABLE TO DUPLICATE ALLEGED FAULT CONDITION. PANEL KEY REPLACED AS A PRECAUTIONARY MEASURE. PROPER DEVICE OPERATION WAS CONFIRMED BY SVC REP. WILL CONTINUE TO MONITOR FOR FREQUENCY AND SEVERITY. SEE DISCLAIMER.
PRESENTED TO PHYSICIAN WITH INCREASING FAINTING SPELLS FOR 2 MONTHS.
THE LARYNGOSCOPE BLADE, (SIZE UNREPORTED) BROKE, NEAR THE CONTACT POINT, DURING AN INTUBATION ATTEMPT. THE INTUBATION WAS BEING PERFORMED IN THE EMERGENCY ROOM. A 42 YR OLD MALE PT, WEIGHING APPROX. 300 LBS, WAS IN COMPLETE CARDIO-PULMINARY ARREST. INTUBATION WAS SUCCESSFUL ON THE SECOND ATTEMPT, USING A REUSABLE BLADE (SIZE UNREPORTED). THE PT HAD A BULL NECK. THE PT'S VITAL SIGNS WERE NOT RESTORED. "I DO NOT BELIEVE TECHNIQUE WAS A (FACTOR); I HAVE SUCCESSFULLY PERFOMED 1500 INTUBATIONS", STATED EMERGENCY ROOM PHYSICIAN. THE BLADE WAS NOT SAVED. THERE WAS NO CAUSAL CONNECTION BETWEEN THE BLADE BREAKING AND THE PT'S DEATH.
NOTE: ALL OF THE INFO CONTAINED IN SECTION F WAS PROVIDED BY THE MFR.
SURGEON BEGAN TO SUTURE. NEEDLE BROKE AND WAS RETRIEVED. SECOND SUTURE NEEDLE WAS USED AND ALSO BROKE OFF WHILE SUTURING. NEEDLE FOUND IN WOUND AFTER SEARCH OF WOUND FOR 10 MIN.
CUSTOMER ALLEGED DEVICE DISPLAYED FAULT CONDITION DURING DAILY FUNCTIONAL TESTING. SVC REP COULD NOT DUPLICATE FAULT CONDITION. PROPER DEVICE OPERATION CONFIRMED.
SECTION F.10 CODE #1085-NOT LABELED. INVESTIGATION OF DEVICE COULD NOT DUPLICATE THE ALLEGED FAULT CONDITION. CUSTOMER WAS ADVISED TO REPLACE THE 6 YR OLD BATTERIES. PROPER OPERATION OF DEVICE WAS CONFIRMED. SEE DISCLAIMER.
PT BECAME INFECTED WITH STAPHYLOCOCCUS EPIDERMIDIS AFTER CATHETER WAS IMPLANTED ON 3/15/96. CATHETER WAS REMOVED AND REPLACED ON 3/26/96. SPECIMENS OF CSF WHICH WERE TAKEN FROM THE CATHETER AT IMPLANT GREW STAPHYLOCOCCUS EPIDERMIDIS THE MORNING AFTER IMPLANT. THE DR FEELS THAT THE CATHETER WAS CONTAMINATED BEFORE IMPLANTATION, NOT INTRAOPERATIVELY. HIS ROUTINE PRACTICE IS TO OPEN CATHETER ONLY AT THE MOMENT HE IS ABOUT TO IMPLANT, AND PLACE IT IMMEDIATELY IN A BACITRACIN CONTAINING SOLUTION.
EVENT PROBLEM CODES (NOT COMPLETED BY USER FACILITY).
CUSTOMER REPORTED DISPLAY DID NOT FUNCTION PROPERLY. NO REPORTED PT INVOLVEMENT. SVC REP REPAIRED DEVCIE AND CONFIRMED PROPER OPERATION.
SECTION F.10 CODE #1182-NOT LABELED. INVESTIGATION OF DEVICE WAS ABLE TO DUPLICATE DISPLAY CONDITION. SVC REP REPLACED LCD DISPLAY AND CONFIRMED PROPER OPERATION. AVAILALBE FREQUENCY AND SEVERITY DATA DO NOT INDICATE FURTHER INVESTIGATION IS REQUIRED AT THIS TIME, HOWEVER, CO WILL CONTINUE TO MONITOR. SEE DISCLAIMER.
THE PT, A IDDM, BEGAN OBTAINING FLUCTUATING BLOOD GLUCOSE RESULTS ON HIS METER(300'S TO 90"S WITHIN A FEW MINUTES OF EACH OTHER). AT 4:0/P, HE TESTED ON HIS METER WITH A RESULT OF "458 OR 460" MG/DL. BASED UPON THIS READING, HE TOOK AN ADD'L 4U REGULAR INSULIN. HIS SON CAME TO CHECK ON HIM AT 4:30/P, FOUND HIM UNCONSCIOUS AND SUMMONED AN AMBULANCE. THE PARAMEDICS PERFORMED A BLOOD TEST ON THEIR METER(UNKNOWN BRAND), BUT COULD NOT OBTAIN A RESULT "IT WAS SO LOW." HE WAS GIVEN IV GLUCOSE AND TRANSPORTED TO THE HOSPITAL. UPON ARRIVAL, HIS BLOOD GLUCOSE WAS "IN THE 80'S." HE WAS NOT TREATED AND WAS DISCHARGED 1 1/2 HRS LATER WHEN HIS BLOOD GLUCOSE REACHED 128 MG/DL. METER MAINTENANCE AND CALIBRATION STATUS IS UNKNOWN AT THIS TIME. THE PT REPORTED THAT BECAUSE OF A VISION PROBLEM, "IT'S HARD TO SEE IF YOU'VE GOT THE RIGHT SPOT. SOMETIMES I MISS HALF THE DOT" ON THE TEST STRIP.
CO HAS COMPLETED INVESTIGATION OF THE MDR INCIDENT. CALIBRATION TESTS INDICATED THAT THE METER IS WITHIN LABELED SPECIFICATIONS. VISUAL EXAMINATION OF THE METER OPTICS FOUND DIRT AND SCRATCHES, WHICH MAY EFFECT METER RESULTS. WE WERE UNABLE TO CONDUCT BLOOD PERFORMANCE TESTING AS THE METER DISCARDED IMMEDIATELY FOLLOWING THE ABOVE CALIBRATION TESTS AND VISUAL EXAMINATION. CORRECTIVE ACTIONS HAVE INSTITUTED TO PREVENT THIS TYPE OF OCCURRENCE IN THE FUTURE. CO CONCLUDES THAT THE INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNK ANOMALY. AT THIS POINT INVESTIGATION OF THIS MATTER IS CLOSED.
VALVE NOT WORKING PROPERLY. SOME RESISTANCE WHEN IRRIGATING. AFTER REMOVAL VALVE SEEMED TO TEST OKAY BUT REMOVED BECAUSE OF POSSIBLE CONCERN OF VALVE MALFUNCTIONING.
SOME RESISTANCE WHEN IRRIGATING IS A NORMAL CHARACTERISTIC OF A FLOW CONTROL VALVE. IF THERE WAS NOT RESISTANCE OT FLOW, OVERDRAINAGE WOULD RESULT.
THE PT REPORTED UNUSEABLE SOUND FROM THE IMPLANT. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MFR'S SPECS. EXPLANTATION/REIMPLANTATION SURGERY HAS NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT. THE HEALTHCARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEVICE SHOULD BE RETURNED TO CO.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA. THE PATELLA POLYETHYLENE ALSO DISASSOCIATED FROM THE METAL BACK.
THIS IS THE SAME PT/EVENT AS MFR #2219689-1996-00045. THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS THEY HAVE NOT BEEN RETURNED TO CO BUT RATHER HAVE BEEN DISCARDED AT THE HOSP. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH COMPONENTS FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MFG.
ON 8/11, THE PT, A IDDM, BEGAN OBTAINING READINGS ON HER METER OF 11,52 AND 29 MG/DL. ALTHOUGH SHE TOOK HER MORNING DOSE OF INSULIN, BASED UPON THE READINGS, SHE DID NOT TAKE ANY INSULIN FOR THE REMAINDER OF THE DAY. SINCE HER STOMACH WAS BOTHERING HER, SHE DRANK SODA, HOWEVER, "MAY NOT HAVE EATEN TOO MUCH" THROUGHOUT THE DAY. BECAUSE OF HER SYMPTOMS OF ELEVATED GLUCOSE, HER HUSBAND TRANSPORTED HER TO THE HOSPITAL BETWEEN 4 AND 6/P THAT EVENING WHERE A LABORATORY BLOOD GLUCOSE RESULT OF 950 MG/DL WAS OBTAINED. SHE WAS TREATED IN THE ER WITH AN IV AND INSULIN DRIP AND LATER ADMITTED TO ICU. THE PT'S HUSBAND REPORTS THAT "THIS HAPPENS PERIODICALLY," HOWEVER, FOR THE LAST FEW YRS, SHE'S HAD MUCH BETTER CONTROL. THE METER IS NOT CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, THE TEST STRIP HOLDER IS NOT REMOVED FOR CLEANING OF THE METER OPTICS. QUALITY CONTROL TESTS ARE NOT PERFORMED, CALIBRATION STATUS IS UNKNOWN. ADDITIONALLY, THE PT STORES HER TEST STRIPS OUTSIDE OF THE VIAL IN THE METER CASE. THE TEST STRIP PACKAGE INSERT STATES TO STORE THE TEST STRIPS IN THEIR ORIGINAL VIAL WITH THE CAP TIGHTLY CLOSED.
H6 RESULT:  NO NON-CONFORMANCES.  CO IS UNABLE TO COMPLETE THIER INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE DUE TO THE FACT THAT THE METER WAS NOT RETURNED TO LIFESCAN.  THEREFORE, CO HAS NOT BEEN ABLE TO EVALUATE THE METER TO DETERMINE WHETHER OR NOT A DEVICE MALFUNCTION MAY HAVE CONTRIBUTED TO THIS EVENT.  BATDCH RECORD REVIEW INDICATES NO NON-CONFORMANCES IN THE MANUFACTURING PROCESS.  AT THIS POINT, CO CONSIDERS THIS MATTER CLOSED.  H6=BATCH RECORD REVIEW.
PT IS AN 84-YR-OLD FEMALE WHO PRESENTED WITH COMPLAINTS OF RIGHT HIP PAIN. THE PT IS STATUS PORT RIGHT TOTAL HIP ARTHROPLASTY, PERFORMED BY ANOTYHER PHYSICIAN. SHE REPORTED THE HIP HAS BECOME INCREASINGLY MORE SEVERE OVER THE PAST SEVERAL MONTHS AND RADIOGRAPHIC EXAM REVEALED A PROTRUSION WITH LOOSENING OF THE ACETABULAR COMPONENT AND WHAT APPEARED TO BE LUCENCY LINES AROUND THE HIP STEM AS WELL. SHE REPORTED PAIN WITH ANY TYPE OF WEIGHTS BEARING ACTIVITY. THE PT WAS ADMITTED TO THE HOSP FOR REVISION OF THE RIGHT TOTAL HIP. DURING SURGERY, A LOT OF BLACK SUBCUTANEOUS TISSUE DEBRIS WAS NOTED WITHIN THE HIP JOINT, FROM A CARBON BASED CUP AND SOME FLUID WAS RELEASED FROM THE JOINT WHEN IT WAS OPENED. INTRAOPERATIVE CULTURES WERE OBTAINED AND REPORTED AS NEGATIVE FOR ORGANISM GROWITH. THE HIP WAS DISLOCATED AND MORE BLACK TISSUE WAS REMOVED.
THE SVC REPORT SHOWS THE DEVICE VOLUME DELIVERY IS OUT OF SPECS. THE SVC TECHNICIAN VERIFIED A LEAK IN THE SYSTEM CAUSING THE VOLUME FLUCTUATION. THE ST INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING.
THE DEVICES WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON A 450LP PT. THREE 512X TROCARS AND ONE 512B BROKE DURING THE CASE. REP REPORTS TROCARS WERE UNDER EXTREME STRESS DURING THE PROCEDURE DUE TO TORQUING TO REACH THE GALL BLADDER. THERE WAS NO CONSEQUENCE TO THE PT.
CONCLUSION: RECORD PURPOSES ONLY: NO ANALYSIS WAS PERFORMED SINCE NO INSTRUMENT WAS RECEIVED. THE INFO YOU PROVIDED HAS BEEN NOTED AND SHARED WITH THE APPROPRIATE MANUFACTURING PERSONNEL.
THE SVC REPORT SHOWS THE DEVICE IS OUT OF SPECS. THE TECHNICIAN VERIFIED DURING ROUTINE MAINTENANCE THE UNIT FAILED TO CYCLE ON AC POWER AND DID NOT SWITCH TO INTERNAL BATTERY WITHIN SPEC. THE ST INSPECTED THE DEVICE AND REPLACED THE BATTERY PACK. THE UNIT PASSED EXTENDED TESTING.
THE INSTRUMENTS WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE 355L BLADE WAS EXPOSED WHEN INSERTED. NO TISSUE WAS DAMAGED AS A RESULT. THE 511S TROCAR GASKET FELL INTO THE TROCAR SHAFT. IT DID NOT GO INTO THE PT AND WAS RETRIEVED FROM THE SHAFT WITHOUT DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT.
A,B)BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT COULD NOT BE DETERMINED WHY THE INSTRUMENT'S BLADE REPORTEDLY REMAINED "EXPOSED" DURING SURGERY. THE INSTRUMENTS WERE RE-ARMED AND CYCLED REPEATEDLY WITHOUT INCIDENT. THE INSTRUMENTS' SAFETY SHIELDS WERE EXAMINED AND TESTED AND FOUND TO FUCNTION AS DESIGNED. NOTE: ONE INTRA-OPERATIVE PHOTO WAS RECEIVED WITH THE INSTRUMENTS DEPICTING AN INSTRUMENT WITH AN EXPOSED BLADE. IT COULD NOT BE CONFIMED IF THIS WAS ONE OF THE INSTRUMENTS RECEIVED.
THE DEVICE AUDIBLE ALARM SOUND IS TO LOW. THE CUSTOMER SUPPORT ENGINEER (CO'S CSE) INSPECTED THE DEVICE AND REPLACED THE AUDIO ALARM. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE ALARM IS OUT OF SPEC, AND NO MALFUNCTION MAY HAVE OCCURRED.
THE DEVICE WAS IMPLANTED AS AN ACCESS PORT. REPORTEDLY, SEVEN MONTHS AFTER IT WAS IMPLANTED A CRACK WAS NOTICED IN THE CATHETER. THE SURGEON IMPLANTED A NEW PORT SYSTEM. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE CATHETER WAS EVALUATED AND CONFIRMED TO HAVE BEEN DAMAGED. WHETHER THE DAMAGE OCCURRED FROM A SCAPEL OR FROM A RUPTURE DUE TO CAPTURE IN THE ANATOMICAL PINCH POINT CANNOT BE RELIABLY DETERMINED.
THE SVC REPORT SHOWS THAT WHILE PERFORMING A ROUTINE PREVENTATIVE MAINTENANCE SVC, THE CUSTOMER SUPPORT ENGINEER NOTICED THE CUSTOMER SUPPORT ENGINEER NOTICED THE VOLUME ON THE AUDIBLE ALARM TO LOW. THE CSE INSPECTED THE DEVICE AND REPLACED THE AUDIBLE ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING.
IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. ON 5/31/96 A LONG TERM SURGEON AT OUR FACILITY WAS IN THE INITIAL PHASE OF PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY. SOME DIFFICULTY WAS ENCOUNTERED WITH INSERTING THE TROCAR BUT THE FUNCTION OF THE INSTRUMENT AT THE TIME WAS NOT IN QUESTION. UNFORTUNATELY WHEN THE ABDOMEN WAS ENTERED IT WAS FOUND THAT THERE WAS A LACERATION OF THE VENA CAVA. THIS WAS REPAIRED QUICKLY. POST OPERATIVELY THE PT DEVELOPED A DVT OF THE LOWER EXTREMITY AND A HEMATOMA THAT RESULTED IN A PROLONGED STAY. EXTENSIVE PEER REVIEW WAS DONE WITHIN 1 WEEK OF THE INCIDENT AND IT WAS FELT THAT THE TECHNIQUE USED BY THE MD WAS WELL WITHIN THE STANDARD PARAMETERS. AT THE TIME A QUESTION WAS RAISED REGARDING THE TROCAR USED AND IF THERE COULD HAVE BEEN AN EQUIPMENT MALFUNCTION. THE SURGEON AND THE PEER REVIEWERS DID NOT THINK SO, HOWEVER AT A GENERAL SURGERY MEETING 7/13/96 (SECOND REVIEW) THE QUESTION AGAIN SURFACED AND THE POSSIBILITY OF MALFUNCTION OF THE TROCAR WAS AGAIN RAISED. CO IS QUITE CONFIDENT THAT THIS WAS NOT USER ERROR AS THIS MD HAS PERFORMED AT LEAST 400 LAPP CHOLECYSTECTOMIES IN THE PAST AND PEER REVIEW ENDORSED HIS TECHNIQUE. FACILITY HAS RECENTLY QUESTIONED OTHER CO STAPLING PRODUCTS AND HAS IN FACT REQUESTED INFO THROUGH THE FOIA. CO IS PRESENTLY AWAITING FDA FINDINGS. THE INTENT OF THIS REPORT IS TO HAVE ON FILE WITH THE FDA A SURGICAL MISADVENTURE THAT MAY OR MAY NOT HAVE BEEN THE RESULT OF EQUIPMENT MALFUNCTION.
THE AUDIBLE ALARM DID NOT SOUND WHEN THE UNIT ENTERED INTO BACK UP VENTILATOR (BUV) MODE. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF TESTING. NO PARTS WERE REPLACED. IT IS NOT VERIFIED THAT THE ALARM FAILED TO ACTIVATE, AND NO MALFUNCTION MAY HAVE OCCURRED.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA. IT WAS EXPECTED PRIOR TO SURGERY AND CONFIRMED DURING THE SURGERY, THAT THE KNEE JOINT WAS INFECTED. AS A RESULT OF THE INFECTION, THE TIBIAL BASEPLATE AND FEMORAL COMPONENTS WERE ALSO REMOVED AT THIS TIME. THE KNEE JOINT WAS PACKED WITH ANTIBIOTIC CEMENT UNTIL 7/29/96 WHEN TOTAL KNEE COMPONENTS WERE RE-IMPLANTED.
INFORMATION HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ON 8/16/96, THE MFR RECEIVED A LETTER FROM THE PT INQUIRING ABOUT THE QUALITY AND DURABILITY OF THE DEVICE. THE DEVICE WAS STATED TO HAVE BEEN IMPLANTED WITHIN THE LEFT SUBCLAVIAN ON 4/15/96 FOR USE IN THE PT'S CHEMOTHERAPY TREATMENTS. THE LETTER STATES THAT THE PT HAD PROBLEMS WITH THE DEVICE FROM THE BEGINNING. THE PT REPORTS THAT IT REQUIRED A CATHETER GRAM WITHIN A FEW DAYS AND REQUIRED THE PT TO ASSUME UNUSUAL BODY POSITIONS IN ORDER FOR ASPIRATIONS AND INFUSION TO BE ACCOMPLISHED UTILIZING THE DEVICE. THE LETTER ADDITIONALLY STATED THAT ON 6/1/96, IT WAS IMPOSSIBLE TO EITHER ASPIRATE FROM, OR INSTILL INTO, THE DEVICE. THE PT REPORTS THAT HE BEGAN EXPERIENCING CHEST PAIN AND DYSPNEA ON MILD EXERTION. THIS SUBSIDED SOMEWHAT WITH REST, BUT PERSISTED SO THAT THE PT REPORTED THE CIRCUMSTANCE TO THE SURGEON WHO INSTALLED THE DEVICE. ON 6/2/96, AFTER DISCUSSING THE PROBLEMS, THE PHYSICIAN REPORTEDLY ADVISED THAT THE DEVICE BE REPLACED. THE PT WAS SCHEDULED FOR REMOVAL AND REPLACEMENT OF THE DEVICE ON 6/10/96. DURING THE INTERVAL FROM 6/2/96 TO 6/10/96, THE PT STATED THAT HE CONTINUED TO HAVE CHEST DISCOMFORT AND DYSPNEA. ON 6/10/96, DURING PRE-OPERATIVE EVALUATION, A CHEST X-RAY WAS OBTAINED AND REVEALED A LARGE SEGMENT OF CATHETER COILED WITHIN THE RIGHT VENTRICLE OF THE HEART. THE PT WAS SENT TO THE CARDIAC CATHETERIZATION LABORATORY WHERE A SNARE HAD TO BE INSERTED THROUGH THE FEMORAL VEIN TO SNARE THE 30CM, OR SO, CATHETER FRAGMENT AND REMOVE IT THROUGH THE POINT OF INSERTION OF THE SNARE AT THE GROIN. UPON REMOVAL OF THE FRACTURED CATHETER, THE PT RETURNED TO THE OUTPATIENT SURGICAL SUITE AND HAD ANOTHER DEVICE INSERTED ON THE RIGHT SIDE OF HIS CHEST. THE PHYSICIAN'S OFFICE CONTACTED FOR FURTHER INFO, HOWEVER, IT WAS REVEALED THAT THE PHYSICIAN HAD MOVED HIS PRACTICE TO ANOTHER STATE AND IS NO LONGER THE PT'S PRIMARY CARE PHYSICIAN.
SINCE CO HAS BEEN UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION ON THIS INCIDENT, INVESTIGATION OF THIS EVENT WAS LIMITED TO A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. IN CONCLUSION, THE PATIENT'S REPORT OF A FRACTURED DEVICE CATHETER IS INCONCLUSIVE. BASED ON THE INFORMATION AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT; HOWEVER, SHOULD ANY ADDITIONAL PERTINENT INFORMATION AND/OR THE DEVICE BECOME AVAILABLE THE MFR WILL REOPEN ITS INVESTIGATION AND SUBMIT A FOLLOW-UP REPORT ON THIS EVENT.
THE PORT WAS IMPLANTED 7/95 IN THE RIGHT SUBCLAVIAN VEIN. ON 8/1/96, AN X-RAY WAS TAKEN WHICH SHOWED THE CATHETER TO BE IN THE PT'S HEART. THE CATHETER FRAGMENT WAS SNARED OUT IN RADIOLOGY.
AN 8.85" FRAGMENT WAS RETURNED FOR EVALUATION. THE BREAK SURFACE OF THE FRAGMENT APPEARED SEMI-GLOSSY BUT ROUGH. THE EDGE OF ONE SIDE OF THE BREAK APPEARED TO BE ROUNDED SMOOTH AND POLISHED FROM WEAR. ON THIS SIDE THERE WAS A MARK THAT CAUSED THE BREAK TO FLARE OUT. THIS MARK IS TYPICAL OF A SUTURE SITE. A GOUGE ON THE INTERIOR WALL OF THE LUMEN INDICATED THIS SUTURE MAY HAVE BEEN AT THE TIP OF THE PORT STEM. IT APPEARS THE TUBING WAS CUT OVER A PERIOD OF A YEAR BY A TIGHTLY TIED SUTURE.
THE UNIT STOPPED DELIVERING VOLUMES. THE SVC TECHNICIAN COULD NOT DUPLICATE THE REPORTED EVENT BUT REPLACED THE CONTROLLER IC AS A PRECAUTION. THE SVC REPORT ALSO SHOWS THAT THE UNIT FAILED THE LEAK TEST. THE INSPECTED THE DEVICE AND REPLACED THE PRESSURE LIMIT AND SAFETY VALVE O-RINGS. THE UNIT PASSED EXTENDED TESTING.
CODE 000: O-RINGS. IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
TIP OF DRILL BROKEN OFF DURING SURGERY AND REMAINED ABOVE MID-SHAFT IN FEMUR. DR USED A BONE PLUG AND ELECTED TO LEAVE BIT IN BONE. CLOSED WITHOUT FURTHER PROBLEM.
MEDWATCH 3500A WAS RECEIVED FROM USER FACILITY. ADDITIONAL INFO THAT WAS RECEIVED IS INCLUDED. ALSO INFO AS REQUESTED ON 9/30/1996. CONCLUSION STATEMENT: IMPROPER USE BY SURGEON.
LETTER RECEIVED INDICATING THAT A PUMP THAT HAD BEEN RETURNED FOR SERVICING OVER A YEAR AGO, HAD PREVIOUSLY BEEN INVOLVED IN AN ALLEGED OVERINFUSION. THE LETTER INDICATED THAT WITHIN A 24 HR PERIOD THE PUMP HAD BEEN STOPPED AND THE PROGRAMMING CHANGED, TWICE BECAUSE THE PT APPEARED TO BE OVER-SEDATED, WITH BREATHING DIFFICULTIES ON ONE OCCASION, EACH TIME THE DOSAGE WAS INCREASED BECAUSE THE PT WAS IN PAIN. IT WAS AT THIS TIME IT WAS NOTED THAT THE LOCK BUTTON WAS NOT IN THE RIGHT POSITION, ONLY HAVING BEEN TURNED HALF WAY. IT WAS ALSO NOTED THAT THE MEDICATION RESERVOIR WAS EMPTY. ACCORDING TO THE LETTER, EVEN THOUGH THE LOCK WAS NOT IN A SECURED POSITION, NO FLUID APPEARED TO BE PASSING THROUGH.
THE MEDIAL MENISCAL BEARING FRACTURED AND THE PATELLA BEARING IS WORN.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFILIATES. D.6.-EXACT SIZE OF THE IMPLANT IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO.
HIGH THRESHOLD AND APPARENT INSULATION BREACH WAS REPORTED. THE LEAD WAS EXPLANTED AND REPLACED.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATIONS DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OF THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, MEDTRONIC IS UNABLE TO PROVIDE COMPLETE INFO REQUIRED IN FORM 3500A. SEE ALSO 2649622-1996-00002. H3. EVALUATION SUMMARY: ANALYSIS OF THE LEAD REVEALED AN INSULATION SEPARATION.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. POST EXPLANT THE PHYSICIAN NOTED THE LEAD IS NOT FRACTURED.
THIS ENTIRE FORM COMPLETED BY MFR. UNABLE TO ANALYZE ELECTRODE PARTIALLY RETURNED. LEAD RECEIVED IN A PARTIAL DISTAL APPROX 32 CM PORTION WITH NO J STIFFENER WIRE DISCREPANCIES. VISUAL INSPECTION UNDER 30X MAGNIFICATION DOES INDICATE THAT THE OUTER POLYURETHANE INSULATION HAS BEEN LACERATED APPROX 1 CM PROXIMAL OF ANODE BAND. X-RAY OF LEAD DISTALLY CONFIRMS NO J STIFFENER WIRE DISCREPANCIES.
THE PORT LEAKS AT THE CATHETER NEAR THE CONNECTOR.
H6 RESULT CODE: THE PRODUCT COULD NOT BE PROPERLY EVALUATED FOR CATHETER LEAKAGE AS THE CATHETER WAS NOT RETURNED. SIX UNUSUAL PUNCTURES WERE SEEN AROUND THE PERIMETER OF THE SEPTUM AND THERE WERE MULTIPLE NEEDLE PUNCTURES IN THE CENTER OF THE SEPTUM. NO DAMAGE TO THE CONNECTOR WAS NOTED. SINCE THE CATHETER AND CATHETER ATTACHMENT LOCK WERE NOT RETURNED, PROPER EVALUATION OF THE EVENT WAS NOT POSSIBLE. THE PRODUCT DID NOT LEAK WHEN TESTED. THE MFG RECORDS FOR THE PRODUCT WERE REVIEWED AND NO ANOMALIES WERE NOTED.
THE RETURNED PRODUCT WAS VISUALLY INSPECTED AND TESTED FOR LEAKAGE. THE PORT OF THE PRODUCT WAS FILLED WITH A BLOOD-LIKE SUBSTANCE BETWEEN THE SEPTUM CASING AND THE IMPORT CUP. THERE WERE TWO LARGE INCISIONS AND MULTIPLE NEEDLE PUNCTURES IN THE SEPTUM MATERIAL. BOTH INCISIONS AND ONE OF THE PUNCTURES PENETRATED THROUGH THE SEPTUM CASING INTO THE SPACE BETWEEN THE IMPORT CUP AND THE CASING. A NEEDLE PUNCTURE WAS SEEN THROUGH THE REINFORMCED SHEETING ON THE BOTTOM OF THE PORT. THE CATHETER HAD FRACTURED APPROXIMATELY .5 CM FROM THE WALL OF THE PORT. IT APPEARED THAT THE CATHETER ATTACHMENT LOCK WAS NOT FULLY ASSEMBLED TO THE WALL OF THE PORT. A SEMICIRCULAR INCISION AROUND THE CATHETER, WHICH APPEARED TO HAVE BEEN CAUSED BY A SUTURE TIE, WAS SEEN AT APPROXIMATELY 1 CM FROM THE FRACTURE SITE. THE RETENTION RINGS ON THE DISTAL END OF THE CATHETER APPEARED TO HAVE BEEN SHEARED OFF. THE PRODUCT DID NOT LEAK WHEN TESTED. THE IMPROPER PLACEMENT OF THE LOCK CAUSED IT TO WEAR THROUGH THE CATHETER CAUSING THE LEAKAGE.
DURING A PTCA PROCEDURE, THE BALLOON OF THIS DEVICE RUPTURED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE BEING RETURNED FOR ANALYSIS.
ON 7/2/84 AN AUS DEVICE WAS IMPLANTED. ON 8/3/88 THE PUMP WAS REVISED. ON 7/31/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS - CUFF AND PUMP.
PUMP WAS NOT FUNCTIONALLY TESTED. CUFF HAD A WEAR LEAK. BALLOON PRESSURE NOT WITHIN SPECS.
INFO HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FORM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
OTHER DEVICE USED: C/N UNKNOWN. ACETABULAR CUP LOT # UNKNOWN. EVAL CODES FOR SECTION H6: 86-100 DEVICE WAS NOT RETURNED FOR EVALUTION, THEREFORE NO CONCLUSION CAN BE DRAWN. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "Y", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNINOWN OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
WASHER/SEAL ON TROCAR CAME OFF AND FELL INTO PT'S ABDOMINAL CAVITY DURING SURGERY. PIECE WAS RETRIEVED EITH AN ENDOLOOP BY THE SURGEON.
CONTACTED SURGEON AND RISK MANAGER. INFO NOT AVAILABLE. SURGEON WILL NOT BE IN THE OFFICE UNTIL MONDAY. NNCL SENT.
PUMP PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS. CUFF HAD OR DAMAGE
THE DEVICE WAS REMOVED DUE TO INFECTION.
MD REPAIRED ACL LT KNEE USING 2 SCREWS GUIDED BY THE GUIDE WIRES PACKAGED WITH THEM. THE WIRES WERE REMOVED, SURGERY ENDED. POST-OP X-RAYS REVEALED PRESSURE OF BROKEN PIECE OF GUIDE WIRE IN PT'S KNEE. PT WAS RETURNED TO THE OR FOR REMOVAL OF WIRE.
PUMP WAS FUNCTIONAL. BALLOON PERFORMED WITHIN SPECS. CUFF HAD OR DAMAGE.
THE DEVICE WOULD NOT POWER UP PROPERLY IN PT USE. THE BASIS FOR THIS ALLEGATION WAS NOT REPORTED. A BACKUP DEFIBRILLATOR/MONITOR WAS MADE AVAILABLE AND USED. NO ADDITIONAL DETAILS CONCERNING THE EVENT WERE REPORTED. THE FACILITY REPORTED THAT THE ALLEGED DISCREPANCY HAD NO ADVERSE AFFECT ON PT OUTCOME, BASED UPON THE USE OF THE BACKUP DEVICE. PT OUTCOME WAS NOT REPORTED.
PROPER DEVICE OPERATION WAS OBSERVED BY CO. THE FACILITY ELECTED TO RETURN THE DEVICE TO USE. AT NO COST CO INSTALLED REPLACEMENT DEVICE POWER SUPPLY. CHARGER, UPPER SWITCH MODULE, REAR PANEL, MAIN PFC AND CONTROL PCB ASSEMBLIES. THE DEVICE WAS THEN RETURNED TO THE FACILITY FOR USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFORMATION ON THIS EVENT TO FDA.
ON 6/20/94 AN AUS DEVICE WAS IMPLANTED. ON 5/8/95 THE BALLOON AND PUMP WERE REVISED. PT REPORTS HE REMAINS WET.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBURED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERSTS OF DEPUY INC. OR ITS AFFILIATES. REF. D.6. PART NUMBER 1952-52-000 IS A SCREW, NOT A GUIDE WIRE. A PIECE OF THE GUIDE WIRE BROKE. THE SCREW DID NOT BREAK.
AN AUS DEVICE WAS IMPLANTED ON 10/15/93. THE CUFF WAS REVISED ON 2/25/94. THE CUFF WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION-RECURRING INCONTINENCE ON 8/6/96 AND REPLACED.
CODE 86: EVAL OF EVENT BASED ON HISTORY OF THE DEVICE AND CONTENT OF THIS EVENT. THIS EVENT WAS REPORTED BY A CO CLINICAL EDUCATION SPECIALIST. PRODUCT KIT SIZE 1 WAS USED FOLLOWING PTCA. THE PHYSICIAN DEPLOYED BOTH COLLAGEN PLUGS ALTHOUGH ONLY 1 SHOULD BE USED PER IFU. THE PHYSICIAN DID NOT FEEL RESISTANCE WHEN THE SECOND PLUG WAS DEPLOYED. IMMEDIATELY POST DEPLOYMENT, A LARGE HEMATOMA DEVELOPED. HEMOSTASIS COULD NOT BE ACHIEVED. A PRESSURE DRESSING AND SANDBAG WERE APPLIED AND BLEEDING WAS CONTROLLED. 8/9, PT HAD LARGE ECCHYMOTIC AREA. THE GROIN WAS SOFT BUT WITHOUT A DISTINGUISHABLE HEMATOMA. PT WAS DISCHARGED TO HOME. 8/13, PT WAS READMITTED, COMPLAINING OF GENERAL WEAKNESS, BRUISING AND PAIN AT GROIN SITE. ULTRASOUND GUIDED COMPRESSION WAS APPLIED TO CORRECT A PSEUDOANEURYSM AND 2 UNITS OF BLOOD WERE TRANSFUSED. 8/14, PT WAS DISCHARGED IN STABLE CONDITION.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED LAPAROSCOPIC PROCEDURE. REPORTEDLY, THE INSTRUMENT LEAKED AND THE SLEEVE WAS DAMAGED. THE SURGEON APPLIED ANOTHER DEVICE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
SENSING DIFFICULTY AND APPARENT CORROSION. THE LEAD WAS EXPLANTED AND REPLACED.
SUBMISSIONS OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATIONS DOES NOT CONSTITUTE AND ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." "ANY MISSING OR INCOMPLETE DATE ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER. MEDTRONIC IS UNABLE TO PROVIDE COMPLETE INFO REQUIRED IN FORM 3500A." SEE ALDO 3649622-1996-00001 SAME EVENT 2ND DEVICE. H3. EVALUATION SUMMARY: ANALYSIS REVEALED AN INSULATION SEPARATION.
CODE 86: EVALUATION OF EVENT BASED ON MFG AND QC PROCEDURES, HISTORY OF DEVICE AND CONTENT OF EVENT DESCRIPTION. INCLUDING RESULTS OF CULTURE. THIS EVENT WAS REC'D AS A CUSTOMER COMPLAINT. WAS SUCCESSFULLY USED FOLLOWING A DIAGNOSTIC PROCEDURE AND PT WAS DISCHARGED TO HOME. 36 HOURS POST DEPLOYMENT PT EXPERIENCED CHILLS AND FEVER. 72 HOURS POST DEPLOYMENT, PT WAS READMITTED FOR INFECTION IN PRODUCT GROIN. TREATMENT I&D, C&S, AND IV ANTIBIOTICS. PT WAS DISCHARGED IN STABLE CONDITION ON ORAL ANTIBIOTICS. CONCLUSION CODE 68: PRODUCT IS ASSUMED TO BE STERILE. ATTRIBUTE INFECTION TO INADVERTENT CONTAMINATION.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION ON 10/7/77 WITH REPLACEMENT ON 6/30/80. PLAINTIFF ALLEGES VARIOUS ILNESSES INCLUDING, BUT NOT LIMITED TO, RASH, FEVER, MEMORY LOSS, CHEST PAIN AND JOINT PAIN.
AN AUS DEVICE WAS IMPLANTED ON 8/17/94. THE BALLOON WAS REVISED ON 9/6/95. THE BALLOON WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE-FLUID LOSS AT BALLOON ON 8/9/96 AND REPLACED.
CATHETER PLACED DURING SURGERY. NIGHT NURSE NOTED NO URINE OUTPUT SINCE 5:00PM THAT EVENING. NOTICED DRESSING WAS SOPPING. DAY NURSE CHECKED PT IN A.M. NEXT DAY AND FOUND BALLOON HAD NOT HELD AND ONLY 1/4"IN. REPLACED WITH FOLEY CATHETER. NO HARM DONE TO PT.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U.IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N.IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
PLAINTIFF REPORTS BILATERAL IMPLANTATION ON 6/30/96 WITH EXPLANT ON 8/19/94. PLAINTIFF ALLEGES VARIOUS ILNESSES INCLUDING, BUT NOT LIMITED TO, RASHES, FEVER, MEMORY LOSS, DIZZINESS, HAIR LOSS AND JOINT PAIN.
DUE TO INSTABILITY, THE TIBIAL INSERT, BASEPLATE, FEMORAL AND PATELLAR COMPONENTS WERE REVISED. SUPERSTABILIZER COMPONENTS WERE IMPLANTED FOR GREATER STABILITY.
AS RECEIVED, TIBIAL COMPONENT IS DISASSOCIATED WITH PLASTIC INSERT EXHIBITING WEAR ON BOTH CONDYLES WHICH HAS A SIGNIFICANT ANTERIOR PREFERENCE. THE POSTERIOR REGIONS SHOW NO WEAR. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE TIBIAL COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. THE LOT CODE OF THE PATELLAR COMPONENT HAS NOT BEEN SUPPLIED AND IS NOT VISIBLE ON THE PART SO THAT A REVIEW OF ITS DEVICE HISTORY RECORD IS NOT POSSIBLE. THE INFO PROVIDED, INCLUDING THE MEDICAL OPINION THAT THE COMPONENTS WERE PUT IN INCORRECTLY IN 1987, AND THE EXAM RESULTS INDICATE THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALIGNMENT AND POSITIONING. INFORMATION HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
DEVICE WAS REMOVED FROM THE PT DUE TO BILATERAL PROXIMAL PERFORATIONS. AN ANOTHER DEVICE WAS IMPLANTED.
THE PT WAS IMPLANTED WITH A SALINE-FILLED VOLUME SIZER ON 8/8/96, FOR SIZING PURPOSES WHEN THE DEVICE WAS TORN. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
ADD'L INFO TO BE SUBMITTED Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION ON 11/15/76 WITH REPLACEMENT ON 8/27/84. PLAINTIFF ALLEGES VARIOUS ILNESSES INCLUDING, BUT NOT LIMITED TO, RASH, NIGHT SWEATS, FEVER, DIZZINESS, AND JOINT PAIN.
A CYLINDER WAS REMOVED FROM THE PT DUE TO FLUID LOSS.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR HOLE IN INNER TUBE.
THE UNITS OF CEMENT SET PREMATURELY. IT HAS ALSO BEEN INDICATED THAT THE SET-UP ROOM WAS VERY WARM. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
INFO HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVAL RESULTS SUGGEST THAT THE CAUSE OF THIS EVENT WAS ATTRIBUTED TO SOME FACTOR EXTERNAL TO OUR PRODUCT. THE RESULTS OF TESTING SIMILAR BATCH LOTS OF PRODUCT INDICATED NO MIXING ANOMALIES. IT IS BELIEVED THAT THE ENVIRONMENTAL CONDITIONS OF THE OR MAY HAVE AFFECTED THE SET-UP TIME OF THE CEMENT.
CODE 86: EVAL OF EVEN BASED ON HISTORY OF DEVICE AND CONTENT OF EVENT DESCRIPTION. THIS EVENT WAS REC'D AS A CUSTOMER COMPLAINT. PRODUCT WAS USED FOLLOWING A PTCA PROCEDURE. HEMOSTASIS WAS ACHIEVED AND AT 13:00 HRS. PT WAS TRANSPORTED TO THE FLOOR. 15:25, PT VOMITED, A HEMATOMA STARTED TO DEVELOP. BLEEDING COULD NOT BE CONTROLLED WITH MANUAL COMPRESSION. CLAMP APPLIED; REMOVED AT 04:00, BLEEDING HAD STOPPED. IN AM, PUT ON BED PAN, HEMATOMA STARTED TO GROW AGAIN. THE FOLLOWING DAY A SURGICAL EVACUATION AND CLOSURE WAS DONE. PT WAS DISCHARGED IN STABLE CONDITION 2 DAYS LATER.
PLAINTIFF REPORTS BILATERAL IMPLANTATION ON 8/27/84 WITH EXPLANT ON 9/15/94. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, RASH, FEVER, NIGHT SWEATS, MEMORLY LOSS AND JOINT PAIN.
DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION-INADEQUATE RIGIDITY. ANOTHER DEVICE WAS IMPLANTED.
CYLINDER HAD A WEAR LEAK. CYLINDER HAD A WEAR LEAK HOLE IN INNER TUBE.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS - CYLINDERS.
PUMP PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
A FEMALE PT, UNDERGOING THYROIDECTOMY, EXPERIENCED REMOVAL OF SKIN ON NECK AND UPPER TORSO WHEN UTILITY DRAPES WERE REMOVED, AT THE END OF THE PROCEDURE. STATED PT HAS SENSITIVE SKIN, BUT NO KNOWN TAPE ALLERGIES. INITIALLY TREATED WITH NEOSPORIN OINTMENT AND OBSERVED. APPROX 5 WKS LATER SOURCE REPORTED THAT PT ALLEGES SCARRING.
DATE SENT TO FDA: DATE THIS REPORT FILED IS 9/13/96, INITIAL REPORT OF THIS OCCURRENCE WAS 7/3/96. ADD'L INFO WAS RECEIVED ON 8/14/96, THAT REQUIRED THIS OCCURRENCE TO BE REPORTED UNDER THE NEW GUIDELINES. H7 OTHER - AN ALTERNATIVE ADHESIVE HAS BEEN IDENTIFED AND IMPLEMENTED AS 8/21/96.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION ON 1/2/81. PLAINTIFF ALLEGES "SIGNIFICANT PAIN AND PHYSICAL DISCOMFORT."
ON 1/31/89 DEVICE WAS IMPLANTED. ON 6/6/95 THE CYLINDERS AND PUMP WERE REVISED. ON 8/8/96 THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER# 4892L 011,
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDERS PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD A WEAR LEAK.
PLAINTIFF REPORTS INITITAL BILATERAL IMPLANTATION ON 4/12/79 WITH EXPLANT ON 3/10/81. LAWSUIT FILED ALLEGING UNDISCLOSED "DAMAGES."
THE CYLINDERS WERE REMOVED FROM THE PT DUE TO A FLUID LOSS AT LEFT CYLINDER AND REPLACED.
CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK.
PT HAD ALLERGIC REACTIONS TO DISINFECTANT. CO TESTED THE LOT RETAINED SAMPLES AND FOUND THEM TO BE WITHIN SPECS. CO QUERIED SOURCE RELATIVE TO THE RINSING PROCEDURE THAT WAS EMPLOYED BY THE CLINIC, AND FOUND THAT THERE SEEMED TO BE SEVERAL ANOMALIES IN THEIR PROCEDURE AMONGST WHICH WERE RECIRCULATION OF THE PRIMING SOLUTION AS OPPOSED TO DISGARDING OF SAME. WHEN PRIMING SOLUTION IS NOT DISGARDED, THE USER RUNS A RISK OF HAVING DISINFECTANT PASSING INTO THE BLOOD COMPARTMENT WHICH WOULD LEAD TO A REBOUND CONDITION; I.E., THE DISINFECTANT COULD BE PASSED ON TO THE PT WHEN DIALYSIS COMMENCES. A FOLLOW-UP CALL WAS MADE ON 8/19/96 TO DETERMINE THE OUTCOME OF THE MODIFIED PROCEDURE. ON 8/15/96 AND 8/16/96, ALL WENT WELL BUT ON 8/19/96, THEY EXPERIENCED FURTHER MINOR ALLERGIC REACTIONS. CO DECIDED THAT A MORE COMPREHENSIVE INVESTIGATION WAS REQUIRED, AND THEREFORE DISPATCHED THE TECHNICAL MANAGER TO VISIT THE CLINIC ON THE FOLLOWING DAY, 8/20/96. ON 8/20/96 A COMPREHENSIVE STUDY WAS MADE ON THE WHOLE RINSING PROCEDURE EMPLOYED BY THE CLINIC, AND PRIOR TO THE VISIT, THE CLINIC FELT THAT THEIR RINSING PROCEDURES NEEDED TO BE WRITTEN TO REFLECT CHANGES IN THE WHOLE PROCEDURE. AFTER THE STUDY WAS COMPLETED, CO REVIEWED THE NEW RINSING PROCEDURE. ON THAT DAY, 8/20/96, AND 8/21/96, THE CLINIC PROCEEDED TO EMPLOY THE NEW PROCEDURES SUGGESTED BY CO AND MFR OF DIALYSIS SYSTEM, AND THEY FOUND THAT THE NEW SYSTEM WORKED WELL. THESE NEW PROCEDURES WILL BE WRITTEN INTO THEIR S.O.P.'S AND ALL PERSONNEL WILL BE TRAINED APPROPRIATELY. CO WILL FOLLOW UP WITHIN A WEEK TO DETERMINE THE CLINIC'S PROGRESS.
THESE INCIDENTS AS DESCRIBED ABOVE DO NOT OCCUR WITH ANY ANTICIPATED FREQUENCY, BUT WILL OCCUR WHENEVER IMPROPER PROCEDURES ARE EMPLOYED BY THE END-USER. PT REACTIONS OCCUR NOT ONLY WITH GLUTARALDEHYDE, BUT ALSO WITH FORMALDEHYDE AND PERACETIC ACID DISINFECTANTS WHICH ARE THE OTHER TWO GERMICIDES USED IN DIALYSIS.THE SEVERITY OF THE PT'S REACTION IN THE CASES CITED IN THIS REPORT WERE EXTREMELY MILD. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RATHER, BASED ON THE INFO THAT CO HAS OBTAINED, CO BELIEVES THAT THE INCIDENT WAS CAUSED BY IMPROPER RINSING PROCEDURES WHICH PROBABLY LED TO A "REBOUND" REACTION.
STAPLES DID NOT FIRE. BOWEL WAS CUT, HOWEVER." REP REPORTS SPOKE WITH A RESIDENT IN ON THE CASE, WHO REPORTED THE DEVICE WAS FIRED, CUT TISSUE, BUT STAPLES WERE MALFORMED.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES. D.6 EXACT SIZE OF THE IMPLANT IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO.
RESULTS OF EVALUATION: CONCLUSION: RECORD PURPOSE ONLY: AS THE INSTRUMENT WAS NOT RECEIVED FOR ANALYSIS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AT LEFT CYLINDER AND REPLACED. ADD'L LOT/SER# 6960M 012.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD TORN FABRIC BULGING. TUBING HAD A FATIGUE AND WEAR LEAK.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AND REPLACED. ADD'L LOT/SER# 0856M 020.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK.
DURING TESTING, UNIT WON'T TURN ON. NO PT INVOLVED.
CO FIELD SERVICE TECHNICIAN VERIFIED THE REPORTED COMPLAINT. A FAULTY "ON" BUTTON ON THE KEYBOARD CAUSED THE DEVICE TO NOT TURN ON. THE KEYBOARD WAS REPLACED AND PROPER OPERATION WAS VERIFIED WITH NO OTHER DEVICE PROBLEMS FOUND. CORRECTION ACTION HAS BEEN TAKEN FOR THIS ISSUE: SAFETY ALERT N-039/041-5.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT DUE TO EROSION AND REPLACED.
COMPLAINANT STATES THE ACETABULAR BEARING INSERT COMPONENT BROKE. SURGICAL TIME TO EXPLANT THE COMPONENT WAS FIVE HOURS. YEAR OF IMPLANT WAS 1989; DATE OF EXPLANT WAS 8/15/96.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES. D.6. EXACT SIZE OF THE IMPLANT IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO.
THE VALVE WAS REMOVED DUE TO A PERIVALVULAR LEAK. VALVE IMPLANTED 110 MONTHS.
SUBMISSION OF INFO BY CO UNDER THE MDR REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. "H11. F10 CODES: PT CODE 2472, LABELED, #2201, LABELED. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A." H3 ANALYSIS: A SMALL HOLE WAS PRESENT IN THE RIGHT CUSP AND MINOR AREAS OF ABRASION WERE NOTED ON THE LEAFLETS. THE RADIOGRAPHS SHOW A SLIGHT INDICATION OF MINERALIZATION AT THE RIGHT NON-CORONARY COMMISSURAL ATTACHMENT AT THE AORTIC WALL; THIS IS INSIGNIFICANT MINERIALIZATION FOR THE PT'S AGE. THE ANALYSIS COULD NOT DETERMINE THE CAUSE OF THE PERIVALVULAR LEAK. F10. DEVICE CODE # 1457, LABELED.
THE ACETABULAR CUP BEARING INSERT IS DEFORMED NECESSITATING ITS REMOVAL.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILITATES.
F9: 16 YEARS. F10: PT CODE: 1715. DEVICE CODE IS 2204. F12 HOSP. F13. NO. F14: REFERE TO D3.
PT IS AN 84 YR OLD FEMALE WHO PRESENTED WITH COMPLAINTS OF RIGHT HIP PAIN. THE PT IS STATUS POST RIGHT TOTAL HIP ARTHROPLASTY, PERFORMED BY ANOTHER PHYSICIAN. SHE REPORTED THE HIP HAS BECOME INCREASINGLY MORE SEVERE OVER THE PAST SEVERAL MONTHS AND RADIOGRAPHIC EXAM REVEALED A PROTRUSION WITH LOOSENING OF THE ACETABULAR COMPONENT AND WHAT APPEARED TO BE LUCENCY LINES AROUND HIP STEM AS WELL. SHE REPORTED PAIN WITH ANY TYPE OF WEIGHT BEARING ACTIVITY. THE PT WAS ADMITTED TO THE HSOP FOR REVISION OF THE RIGHT TOTAL HIP. DURING SURGERY A LOT OF BLACK SUBCUTANEOUS TISSUE DEBRIS WAS NOTED WITHIN THE HIP JOINT, FROM A CARBON BASED CUP AND SOME FLUID WAS RELEASED FROM THE JOINT WHEN OPENED. INTRAOPERATIVE CULTURES WERE OBTAINED AND REPORTED AS NEGATIVE FOR ORGANISM GROWTH. THE HIP WAS DISLOCATED AND MORE BLACK TISSUE REMOVED.
INFO RECEIVED ON 8/13/96 INDICATES A REVISION SURGERY WAS PERFORMED ON 8/4/96. IT IS UNCERTAIN WHICH, IF ANY, COMPONENTS WERE REVISED. CO HAS REQUESTED ADD'L INFO.
PT HAD BEEN WORKING IN THE ER FOR 14 YRS. DURING THIS PERIOD OF TIME PT WAS USING LATEX GLOVES WHICH IRRITATED HER HANDS. LATER ON AS PT CONTINUED USING THE LATEX GLOVES, THERE WERE 2 EPISODES IN WHICH SHE EXPERIENCED ABDOMINAL CRAMPING, HEADACHE AND TIGHTNESS OF THROAT. PT DECIDED TO USE VINYL GLOVES. OVER THAT PERIOD OF TIME, PT DEVELOPED ASTHMA, SHORTNESS OF BREATH, COUGH AND HAYFEVER. AN ANTIHISTAMINE WAS ADMINISTERED WITHOUT ANY POSITIVE RESULTS. PT WAS REQUIRED TO CARRY AN "EPI-KIT" AND WEARS A MEDICAL ALERT BRACELET. PT IS NO LONGER WORKING AS AN RN.
THE CUFF WAS REMOVED FROM THE PT DUE TO URETHRAL ATROPHY AND REPLACED.
HEALTH CARE PROFESIONAL EXPERIENCED ANAPHYLACTIC REACTION AND OCCUPATIONALLY-INDUCED ASTHMA.
AN ECG TRANSMITTER, PART OF THE TELEMETRY SYSTEM, FAILED TO INDICATE AN ALARM DURING A MYOCARDIAL EPISODE. TRANSMITTER PROBLEMS SIMILAR TO THIS HAVE OCCURRED DURING THE PAST NINE MONTHS. TRANSMITTERS HAVE FAILED EVEN ON A SIMULATOR. BATTERIES, LEADS AND ELECTRODES WERE CHANGED.
DEVICE WAS IMPLANTED ON 9/23/88. THE BALLOON WAS REVISED ON 12/8/89 AND IN 1993, DAY/MONTH NOT INDICTED. THE BALLOON WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE ON 8/13/96 AND REPLACED.
APPLIER USED DURING PROSTATE SURGERY. TIP WAS BROKEN DURING THE OPERATIVE PROCEDURE AND NOTED BY THE SCRUB ASSISTANT. THERE WAS NO INJURY TO THE PT. PIECE WAS NEVER RETRIEVED.
IT HAS BEEN REPORTED THAT AN IMPLANT HAS FRACTURED. PT INJURY HAS NOT BEEN REPORTED.
AFTER THE DEVICE WAS INSERTED WITHOUT DIFFICULTY AND BEFORE THE GUIDE WIRE HAD BEEN REMOVED, THE PT BECAME TACHYCARDIC, HAD A CHANGE IN CONSCIOUSNESS AND HAD SOME TROUBLE BREATHING. THE PT REMAINED RESPONSIVE AND NEEDED "EPINEPHRINE AND INTRAVENOUS FLUID BOLUS" BEFORE BEING TRANSFERRED TO THE ICU TO BE MONITORED AND RECEIVE ADD'L MEDICATIONS (STEROID OR ANTIHISTAMINES). THE PT RECOVERED SHORTLY AND WAS DISCHARGED HOME WITH THE LINE IN PLACE FOR ANTIBIOTIC THERAPY. THE SURGEON REPORTS, "THE CLEAR SILASTIC COATING WAS CRACKED ALL THE WAY AROUND THERE WERE 2 LAYERS FIBRIN HAD FORMED ALL AROUND AND INSIDE IT."
THE CUFF AND BALLOON WERE REMOVED FROM THE PT DUE TO A CUFF MALPOSITION AND REPLACED.
PT HAD MID LINE CATHETER PLACED 10:30 AM WITH DILAUDID DRIP. NO DIFFICULTY AT TIME OF INSERTION. THE CATHETER WAS INSERTED 6 IN INTO L ANTECUBITAL. PT DID WELL AND EXPERIENCED GOOD PAIN RELIEF UNTIL ABOUT 3:45 PM WHEN PT DESCRIBED SEVERE FACIAL FLUSHING AND SHORTNESS OF BREATH AND SENSATION OF DOOM. DR NOTIFIED IMMEDIATELY AND CATHETER REMOVED. PHARMACIST FELT ANAPHYLACTIC SHOCK COULD NOT OCCUR THAT LATE FROM A SHOT GIVEN AS ORDERED. ORAL DECADRON GIVEN AS ORDERED. MFR CALLED BY RN. PHARMACIST FELT ANAPHYLACTIC SHOCK COULD NOT OCCUR THAT LATE FROM A SILICONE CATHETER. HE THOUGHT IT NORMALLY OCCURRED WITHIN 30 MINS TO 1 HR AFTER INSERTION.
INFO RECEIVED ON 8/13/96 INDICATES A PT BEGAN COMPLAINING OF NOCTURIA 16-20 DAYS POST-OPERATIVE. UNABLE TO OBTAIN ADD'L INFO. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.
IT HAS BEEN REPORTED THAT TWO ABUTMENT SCREWS FRACTURED WITHIN TWO IMPLANTS. THE SCREWS WERE REMOVED. THE FIXTURES ARE STILL IN THE PT'S MOUTH. NO PT INJURY HAS BEEN REPORTED.
INFO RECEIVED ON 8/13/96 INDICATES THE PT WAS EXPERIENCING SOME POST-ACTIVATION STRESS URINARY INCONTINENCE. INFO RECEIVED ON 8/15/96 INDICATES THE CUFF WAS REMOVED FROM THE PT DUE TO URETHRA EROSION AT CUFF AND REPLACED.
THE WATER TRAP CAME APART CAUSING A LEAK IN THE CIRCUIT. OPERATIONALLY, THE INTEGRITY OF THE MECHANICAL VENTILATION PARAMETERS WAS NOT MAINTAINED DUE TO THE LEAK IN THE VENTILATOR CIRCUIT. THE PT'S SATURATION DECREASED TO THE 70% RANGE. THE PT WAS MANUALLY VENTILATED WITH 100% O2 UNTIL A REPLACEMENT CIRCUIT WAS PUT ON THE VENTILATOR. THE TOTAL TIME OF THE EVENT WAS APPROX 12 MINS UNTIL THE PT WAS PUT BACK ON MECHANICAL VENTILATION. ONCE THE PT WAS PUT BACK ON MECHANICAL VENTILATION, THE OXYGEN SATURATION IMPROVED TO AN ACCEPTABLE LEVEL. PT'S WEIGHT 673 G.
PT SUSTAINED RETRO PERITONEAL HEMORRHAGE FOLLOWING PLACEMENT OF A SUBCLAVIAN TRANSLUMBAR INTRACAVAL CATHETER. NO OTHER ALTERNATIVE VASCULAR ACCESS FOR HEMODIALYSIS.
DEVICE WAS REMOVED FORM THE PT DUE TO TUBING CONNECTING THE PUMP TO THE RESERVOR EXTRUDED THROUGH A SKIN BREAK. ANOTHER DEVICE WAS IMPLANTED.
FATHER CALLED STATING INFUSION WAS NOT COMPLETE AT SET TIME. FATHER WAS DIRECTED TO PUSH "SET/CLEAR" AFTER RES VOL AND INFUSION SCREEN. PT'S FATHER ESTIMATED THAT GREATER THAN 10% DID NOT INFUSE.
THE ENDS OF THE VENA CAVA FILTER FLARED OUT WHEN TRYING TO PUT IT THROUGH THE INTRODUCER. THE FILTER WAS NOT USED ON THE PT, BUT THE INTRODUCER WHICH IS INCLUDED IN PACKET TO THE MFR WAS IN DIRECT CONTACT WITH THE BLOOD OF THE PT.
17 YR OLD PT WITH VARIOUS NEUROLOGICAL DISORDERS EXPERIENCED LOCALIZED EDEMA AND PAIN AT THE SITE DURING A NORMAL SALINE INFUSION. THE INFUSION WAS DISCONTINUED, AND THE SYMPTOMS RESOLVED WITHOUT MEDICAL INTERVENTION. THE PT WAS ADMITTED FOR AN ADD'L NORMAL SALINE INFUSION AND, AT THAT TIME, EXPERIENCED DYSPNEA AND CHEST TIGHTNESS DURING THE INFUSION. THE INFUSION WAS DISCONTINUED, AND THE SYMPTOMS RESOLVED WITHOUT MEDICAL INTERVENTION.
DATE SENT TO FDA: 9/13/96. REPEATED ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO FROM THE REPORTING FACILITY, BUT THE REPORTER DID NOT RESPOND. ADD'L INFO FOR SECTION F10: ADDED CODE #1994-PAIN-NOT LABELED;CODE#1816-NOT LABELED;CODE#2463-NOT LABELED;CODE#1820-NOT LABELED. THE PT EXPERIENCED LOCALIZED EDEMA, PAIN AT THE SITE, DYSPNEA AND CHEST TIGHTNESS DURING A NORMAL SALINE INFUSION. THE PT WAS DIAGNOSED WITH A PRE-EXISTING NEUROLOGICAL DISORDER. THE FACILITY DID NOT PROVIDE A DEVICE SAMPLE OR LOT NUMBER FOR ANALYSIS. NO FURTHER INFO WAS AVAILABLE FROM THE FACILITY. A MEDICAL CONSULTANT, DR WAS ASKED TO REVIEW THIS COMPLAINT. DR STATED THAT THE PT APPEARED TO HAVE EXPERIENCED ALLERGIC REACTIONS ON THE TWO OCCASIONS AS REPORTED AND THAT ALLERGIC REACTIONS TO FEP ARE THEORETICALLY POSSIBLE, THOUGH RARELY REPORTED. DR DEFINED ADD'L FACTORS THAT MAY HAVE CONTRIBUTED TO THE ALLERGIC REACTION TO INCLUDE THE USE OF ANTISEPTIC PREPPING SOLUTION, PRESERVATIVES WHICH MAY BE CONTAINED IN BACTERIOSTATIC SALINE (I.E. FROM A MULTIDOSE VIAL IF USED AS A FLUSH), AND THE USE OF AN IV ADMINISTRATION SET WITH A LATEX BULB. HIS OPINION IS THAT AN ALLERGIC REACTION TO THE CATHETER IS POSSIBLE BUT REMAINS UNPROVEN WITH THE INFO AVAILABLE. HE ADVISES THE PT TO AVOID EXPOSURE, IN THE FUTURE, TO ALL THE ABOVE MENTIONED FACTORS AS WELL AS ANY CONTACT WITH FEP CATHETERS.
F9: 9 YEARS. F10: PT CODE: 1964. DEVICE CODE: 2204. F12: HOSPITAL F13: NO. F14: RETER TO D3.
THE VALVE WAS REMOVED DUE TO MITRAL REGURGITATION. VALVE WAS IMPLANTED 198 MONTHS. PT AGE AT IMPLANT 52 YEARS OLD.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." H.11. F10 CODES: PT CODE 1964 -LABELED #2376- LABELED. DEVICE CODE: 2320 -LABELED. CONCLUSION CODE #68 -DEVICE PERFORMED AS EXPECTED AND WAS RELATED TO THE REPORTED EVENT. A MEDWATCH FORM WAS NOT RECEIVED FROM THE USER FACILITY THEREFORE, INFO WAS FILLED IN BY CO WITH INFO RECEIVED FROM THE MD. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS INABLE TO COMPLETE FORM 3500A." H3 ANALYSIS SHOWS THAT THE MITRAL REGURGITATION WAS THE RESULT OF A HOLES AND DETERIORATION OF THE LEAFLETS THAT ARE ASSOCIATED WITH MINERALIZATION. THE RADIOGRAPH SHOWS SMALL AREAS OF MINERALIZATION. THIS IS THE SAME PT AS REPORT #2025587-1996-00009.
WHEN A CERTAIN NEONATAL ISOTHERMAL CIRCUIT IS USED WITH A CERTAIN MODEL VENTILATOR, AT FLOW RATES FROM 15-30 L/MIN, THE VENTILATOR WILL EITHER DECREASE ITS INSPIRATORY TIME OR FAIL TO CYCLE WITH AN INCREASED PEEP SETTING. THE PROBABILITY OF THIS OCCURRENCE IS GREATEST AT THE HIGHEST FLOW RATE. THE INSPIRATORY TIME DISPLAY WILL NOT INDICATE THE RPOBLEM. HOWEVER, THE ACTUAL PHYSICAL CLOSURE OF THE EXPIRATORY VALVE WILL BE DELAYED OR ELIMINATED. THE FIRST SYMPTOM OF THIS PROBLEM AT THE LOWER FLOW RATE WILL BE A TWITCH OF THE PRESSURE GAUGE NEEDLE, AT THE BEGINNING OF INSPIRATION. THIS APPLIES TO THE NON-ASSISTED VERSION OF THE VENTILATOR. BOTH MFRS AGREE AGREE THAT THE COMPLIANCE AND RESISTANCE OF THE CIRCUIT ARE CRUCIAL FOR CORRECT VENTILATOR FUNCTION. HOWEVER, THE MFR OF THE CIRCUIT ISOTHERMAL DOES NOT ADMIT THAT THE VENTILATOR IS UNRELIABLE WHEN USED IN ITS UPPER FLOW RATE RANGE WITH THE NEONATAL CIRCUIT. SINCE THE INSPIRATORY TIME CAN BE DECREASED BY ANY PERCENTAGE, IT IS LIKELY TO BE UNRECOGNIZED AS SOME PRESSURE WILL STILL BE INDICATED ON THE GAUGE. THIS IS A CONSISTENT COMPATABILITY PROBLEM WITH MAKE OF VENTILATOR AND THIS PARTICULAR ISOTHERMAL MAKE OF NEONATAL CIRCUIT.
SCREW BROKE ABOUT THREE MOS. POST-OP. PT WAS THEN BRACED. EXPLANTATION OF HARDWARE OCCURRED ABOUT ONE YR POST-OP DUE TO FAILED FUSION.
PT WAS TREATED ON 9/3/96 TO THE NASOLABIAL FOLDS AND VERMILION OF THE UPPER LIP. AT THE TIME OF TREATMENT TO THE LEFT NASOLABIAL FOLD, A BLANCH DEVELOPED FOLLOWED BY A CYANOTIC, THEN BRUISED APPEARANCE. LATER THAT EVENING, THE PT CALLED THE PHYSICIAN TO REPORT INCREASED BRUISING. PAIN AND SWELLING AT THE SITE. HE PRESCRIBED AN ORAL ANTIBIOTIC. ON 9/7/96, THE PT PRESENTED WITH AN ESCHAR AT THE LEFT NASOLABIAL FOLD. THE PHYSICIAN DIAGNOSED A LOCAL NECROSIS; NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS PRESCRIBED OR PLANNED.
THE VALVE WAS REMOVED DUE TO AORTIC REGURGITATION. VALVE WAS IMPLANTED 198 MONTHS. PT AGE AT IMPLANT WAS 52 YEARS OLD.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." H11. F10 CODES: PT CODE 1716 -LABELED, #2372 -LABELED. DEVICE CODE 2320 -LABELED. CONCLUSION CODE #68 -DEVICE PERFORMED AS EXPECTED AND WAS RELATED TO THE REPORTED EVENT. A MEDWATCH FORM WAS NOT RECEIVED FROM THE USER FACILITY THEREFORE, INFO WAS FILLED IN BY CO WITH INFO RECEIVED FROM THE MD. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A." H3 ANALYSIS: THE ANALYSIS SHOWS THAT THE AORTIC REGURGITATION WAS THE RESULT OF A HOLES AND DETERIORATION OF THE LEAFLETS THAT ARE ASSOCIATED WITH MINERALIZATION. THE RADIOGRAPH SHOWS MODERATE TO EXTENSIVE MINERALIZATION AT ALL OF THE COMMISSURES THAT EXTENDS ONTO THE LEAFLETS. THIS IS THE SAME PT AS REPORT #2025587-1996-00008.
AN INFANT HEEL WARMER EXPLODED WHEN THE NURSE ATTEMPTED TO ACTIVATE THE CONTENTS, GLYCERINE AND SODIUM THIOSULFATE. THE FLUID WENT INTO THE NURSES EYE. SHE IRRIGATED HER EYE WITH WATER AND CALLED POISON CONTROL. SHE WAS WEARING A CONTACT LENS WHICH MAY HAVE PROTECTED HER EYE. THE NURSE HAS HAD NO EYE PROBLEMS AS OF REPORT. SHE DID NOT SEE AN MD, THE BABY WAS NOT HURT.
TUBING IS DEFECTIVE. UNABLE TO DRAW FLUID INTO DRIP CHAMBER.
A PT RECEIVED HER FIRST TREATMENT ON 6/26/96 WITH 2 FORMULATIONS OF COLLAGEN INTO THE GLABELLA, HORIZONTAL FOREHEAD LINES, PERIORBITAL LINES, VERTICAL LINES ABOVE THE UPPER LIP, NASOLABIAL FOLDS, LEFT CHEEK, AND SCARS ON THE NOSE. ON 7/31/96, THE PT NOTED REDNESS, SWELLING, AND INDURATION AT THE HORIZONTAL FOREHEAD TREATMENT SITES. ON 8/16/96, SHE TELEPHONED THE OFFICE AND ALLEGED INTERMITTENT SYMPTOMS WHICH WORSENED WHEN UNDER STRESS. ON 8/19/96, SHE PRESENTED WITH SWELLING AND INDURATION AT THE HORIZONTAL FOREHEAD TREATMENT SITES. THE SKIN TEST SITE AND ALL OTHER TREATMENT SITES REMAINED ASYMPTOMATIC. THE MD DIAGNOSED A HYPERSENSITIVITY; MASSAGE AND TOPICAL ULTRAVATE WERE PRESCRIBED. IN LATE 8/96 (EXACT DATE UNK), ALOPECIA OF THE SCALP WAS NOTED; THE PHYSICIAN DID NOT BELIEVE THE ALOPECIA WAS RELATED TO THE COLLAGEN BUT BELIEVED IT WAS PROBABLY RELATED TO STRESS. ON 9/3/96, THE PT PRESENTED WITH SWELLING AND INDURATION AT THE GLABELLAR AND PERIORBITAL TREATMENT SITES; INTRALESIONAL KENALOG WAS PRESCRIBED.
PAT. PROB. CODE: 1707 - LABELED. PAT. PROB. CODE: 1877 - NOT LABELED.
MEDICATION WAS ATTACHED TO PUMP; AFTER 12 HRS PUMP ALARMED "INFUSION COMPLETE." WHEN DISCONNECTING BAG FROM PUMP FOUND THAT THE BAG WAS STILL FULL OF MEDICATION. PT CALLED RN WHO WENT TO THE HOME; WHEN RN REMOVED PUMP FROM CARRIER/POUCH, A SMALL GRAY "CAP" FELL OUT OF THE POUCH. UPON INVESTIGATION IT WAS DISCOVERED THAT THE GRAY "CAP" CAME OFF OF THE "SPINDLE", THAT TURNS IN THE PUMP ONLY - IT DOES NOT CONNECT WITH THE CASSETTE.
A PT WAS SKIN TESTED IN THE FOREARM ON 9/4/96. ON 9/11/96, THE PT PRESENTED WITH ERYTHEMA AND SWELLING AT THE TEST SITE (EXACT DATE OF ONSET UNK). THE PHYSICIAN DIAGNOSED A POSITIVE SKIN TEST; AN OVER-THE-COUNTER ANTIHISTAMINE WAS PRESCRIBED.
IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW HAS FRACTURED INSIDE AN IMPLANT. THE ABUTMENT SCREW WAS REMOVED SUCCESSFULLY, THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW HAS FRACTURED INSIDE AN IMPLANT. THE ABUTMENT SCREW WAS REMOVED FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
LEADS WERE REMOVED FROM SERVICE DUE TO "LEAD FRACTURE." THEY WERE CAPPED AND WILL NOT BE RETURNED FOR ANALYSIS. IMPLANT DATE: 7/29/92. REMOVED FROM SERVICE DATE: 4/9/96. TOTAL IMPLANT MONTHS: 46.
THE TROCAR WAS USED ON THE PT DURING A DIAGNOSTIC LAPAROSCOPY ON THE AFTERNOON OF 4/5/96. IT WAS STATED THAT THE TROCAR MAY NOT HAVE RETRACTED WHEN USED ON THE PT CAUSING AN ILIAC VEIN INJURY. THE LOT NUMBER IS NOT ON THE TROCAR UNIT. PERSONNEL IN SURGERY STATE THAT IT CAME FROM THE BOX MARKED WITH LOT# J41U3E.
THE RADIOLUCENT SLEEVE BROKE WHILE INSIDE A PT'S ABDOMEN DURING SURGERY.
THE LOCK ENGAGED DURING THE INSERTION PROCESS OF THIS DEVICE WHICH DID NOT ALLOW IT TO BE ADVANCED FURTHER INTO THE VEIN. THE CATHETER BUCKLED AND IT CAME OUT OF THE SHEATH. A BLOOD RETURN WAS VISUALIZED AND THE DEVICE WAS THREADED 3 INCHES BEFORE THE LOCK ENGAGED. IT IS NOT KNOWN IF THE CATHETER TAB WAS PULLED BACK. INFUSION OF FLUIDS WAS STARTED WHEN THE SITE INFILTRATED AND THE CATHETER DISCONTINUED. THE PT WAS IN CRITICAL CONDITION. THERE WAS NO OTHER PERIPHERAL INTRAVENOUS SITE ACCESSIBLE AND A SURGEON WAS NOT AVAILABLE FOR A CENTRAL LINE. THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR TREATMENT. EVENT DESCRIPTION CLARIFIED. ADD'L INFO INDICATES THAT VEIN SITE WAS LEFT ANTECUBITAL.
DATE SENT TO FDA: 10/11/96. H2 JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MANUFACTURE AND SALE OF THE STREAMLINE, LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 9/18/96.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSION FORM THE AVAILABLE INFO ON "NORMAL" OR "LOW IMPEDANCE." NO FURTHER INFO IS AVAILABLE.
UNIT WAS NOT ADEQUATELY SENSING THE INSPIRATORY EFFORT OF THIS PT. THIS PT'S WORK OF BREATHING WAS REPORTED TO BE MARKEDLY HIGH. THIS HOSP REPORTED A PROGRESSIVE DETERIORATION OF THIS PT. THIS PT CODED AND EXPIRED EARLY THE NEXT MORNING. THIS HOSP IS NOT SURE IF THE DEATH OF THIS PT IS RELATED TO THE INCREASE WORK OF BREATHING.
THE REPORTED EVENT WAS TRACED TO THE PT CIRCUIT SET-UP BEING USED. THIS DEVICE DID NOT MALFUNCTION AND OPERATED PER SPECIFICATIONS WHEN CHECKED. THE PT CIRCUIT SET-UP USED FOR THIS PT INCLUDED A NUMBER OF FILTERS IN-LINE IN THE INSPIRATORY LEG OF THIS CIRCUIT. THESE FILTERS CAUSED ADDITIONAL RESISTANCE IN THE PT CIRCUIT. THE PT HAD TO OVERCOME THIS RESISTANCE IN ORDER TO DRAW AIR FROM THE VENTILATOR. WHEN THESE FILTERS WERE REMOVED FROM THE PT CIRCUIT, THE VENTILATOR OPERATED NORMALLY. THIS HOSPITAL WAS INSERVICED IN THE PROPER TECHNIQUE FOR PRESSURE AND FLOW TRIGGERING BY CO'S CLINICAL STAFF. SECTION F WAS ENTERED BY THE MFR BASED FON INFROMATION PROVIDED BY THE HOSP.
FIELD SVC ENGINEER WAS CHANGING THE COLLIMATOR. WHEN PUTTING IT IN THE COLLIMATOR STAND IT RELEASED FROM THE CART AND FELL.
LEADS WERE REMOVED FROM SERVICE BECAUSE OF A "RATE SENSING ISSUE." ANOTHER DEFIBRILLATION LEAD WAS IMPLANTED. IMPLANT DATE: 2/4/96. REMOVED FROM SERVICE: 8/14/96. TOTAL IMPLANT MONTHS: 54.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON "NORMAL" OR "SENSING INTERMITTENTLY." NO FURTHER INFO IS AVAILABLE.
A DEVICE WAS PARTIALLY INSERTED INTO THE CEPHALIC VEIN WHEN AN "OBSTRUCTION" WAS MET. IT WAS THEN FLUSHED WITH PRESERVATIVE FREE SALINE. THE PT DEMONSTRATED ANXIETY AND COMPLAINED OF FEELING LIKE SHE WAS GOING TO "PASS OUT". AND REQUESTED TO LIE DOWN. HER BP WAS 150/98, PULSE WAS 100 AND BOUNDING. IT WAS THEN NOTED THAT THE INSERTER HAD FORGOTTEN TO RELEASE THE TOURNIQUET. ONCE THE TOURNIQUET WAS RELEASED THE INSERTER CONTINUED TO EXPERIENCE DIFFICULTY ADVANCING THE DEVICE. THE CATHETER WAS DISCONTINUED AND OXYGEN WAS ADMINISTERED. ANOTHER DEVICE WAS PLACED SUCCESSFULLY LATER THAT DAY.
DATE SENT TO FDA: 10/11/96. H2 JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MFR AND SALE OF THE STREAMLINE, LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 9/18/96.
PHYSICIAN INSERTED CATHETER INTO BODY, HOWEVER HE COULDN'T CONFIRM THE PLATINUM MARKER UNDER THE FLUOROSCOPY. HE ADVANCED THE CATHETER A LITTLE, THEN THE DISTAL TIP DAMAGED THE WALL OF VESSEL AND SPASM OCCURRED". HE SUBSEQUENTLY PULLED THE CATHETER OUT OF THE BODY AND HE FOUND THE DISTAL CLEAR SHAFT MISSING. HE DID NOT NOTICE THE SHAFT HAD RIPPED WHEN HE REMOVED THE PROTECTIVE SHEATH.
A NEW PACKAGING CONFIGURATION THAT WILL NOT USE THE PINK SHEATH TO PROTECT THE GUIDEWIRE IS BEING VALIDATED. THE NEW PACKAGING IS SCHEDULED FOR IMPLEMENTATION BY THE END OF THIS YEAR. THE MOST PROBABLE CAUSE FOR THE FAILURE OF THE DEVICE COULD BE RELATED TO THE STICKINESS OF THE PINK SHEATH WHICH REQUIRED THE USE OF EXCESSIVE TENSILE FORCES IN ORDER TO REMOVE THE CATHETER FROM ITS PROTECTIVE SHEATH. THIS INFO IS BASED ON INFO SUPPLIED TO CO WITHOUT CO'S INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. CO ANALYSIS FOUND THE CATHETER WAS RETURNED ITSELF IN A SMALL PLASTIC BAG. THE PINK SHEATH WITH THE DETACHED SEGMENT WAS NOT RETURNED. DURING THE ANALYSIS, IT WAS CONFIRMED THAT THE DISTAL SHAFT WAS MISSING, HAVING DETACHED WITH A CLEAN CIRCUMFERENTIAL FRACTURE AT THE JUNCTION TO THE POLYPROPYLENE SHAFT. IT HAS BEEN REPORTED THAT DUE TO THE STICKY CHARACTERISTIC OF THE PINK SHEATH, THE SHEATH ADHERES TO THE CATHETER. THIS CAN RESULT IN FRACTURING THE CATHETER IF CARE IS NOT TAKEN WHEN REMOVING THE CATHETER.
LEADS WERE REMOVED FROM SERVICE BECAUSE OF A "RATE SENSING ISSUE." ANOTHER DEFIBRILLATION LEAD WAS IMPLANTED. IMPLANT DATE: 2/4/92. REMOVED FROM SERVICE: 8/14/96. IMPLANT MONTHS: 54.
THIS IMPLANTABLE PULSE GNERATOR (IPG) WAS EXHIBITING EARLY BATTERY DEPLETION. AN INVASIVE PROCEDURE FOUND AN INSULATION FRACTURE ON THE ATRIAL LEAD. THE IPG WAS EXPLANTED AND THE ATRIAL LEAD WAS REMOVED FROM SVC.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAIALBLE INFO ON "NOMAL" OR "SENSING INTERMITTENTLY." NO FURTHER INFO IS AVAILABLE.
A DEVICE WAS INSERTED WITHOUT DIFFICULTY. THE PT WAS RECEIVING ROCEPHIN DURING HIS HOSPITALIZATION. THE DEVICE WAS CONTINUOUSLY FLUSHED WITH SALINE DURING THE INSERTION. IT WAS THEN HEPARINIZED. IMMEDIATELY AFTER INSERTION THE PT BEGAN TO DEVELOP ITCHING AND 15 MINUTES POST INSERTION HE DEVELOPED A GENERALIZED RASH WITH CONTINUED ITCHING. BENADRYL WAS ORDERED. THE RASH AND ITCHING SUBSIDED PRIOR TO ADMINISTRATION OF THE BENADRYL. THE BENADRYL WAS GIVEN INTRAVENOUSLY. THE DEVICE WAS NOT REMOVED.
LEADS WERE REMOVED FROM SERVICE DUE TO "LEAD FRACTURE." THEY WERE CAPPED AND WILL NOT BE RETURNED FOR ANALYSIS. IMPLANT DATE: 7/29/92. REMOVED FROM SERVICE DATE: 4/9/96. IMPLANT MONTHS: 46.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNBLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON "NORMAL" OR "LOW IMPEDANCE." NO FURTHER INFO IS AVAILABLE.
ALLEGED INFECTION. FOLLOW-UP FINDINGS: ETIOLOGY UNKNOWN.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVAL CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF CO'S EVAL OF THE DEVICE. MCGHAN MEDICAL'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. FILING A MDR DOES NOT CONSTITUTE AN ADMISSION BY MMC THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. REPORTS ARE BASED ON INFO SUPPLIED TO MCGHAN MEDICAL AND THE SUBSEQUENT INVESTIGATION.
DURING KNEE REPLACEMENT SURGERY ON 8/19/96, THE ORTHOPAEDIC SURGEON FOUND THE 7 DEGREE BUSHING TO BE INCORRECTLY MARKED, RESULTING IN INCORRECT BONE CUTS.
THE INFORMATION SHOWN IN SECTION F WAS OBTAINED AND PROVIDED BY THE MFR, NOT THE DEVICE USER FACILITY. EVALUATION SUMMARY WAS SHOWN IN BLOCK H10 IN THE INITIAL REPORT.
A THIRD ATTEMPT TO INSERT THE DEVICE INTO AN APPREHENSIVE PT WAS SUCCESSFUL AND WAS THREADED THE FULL LENGTH. A FLUSH OF NORMAL SALINE AND HEPARINIZED SALINE WAS USED. AS THE INSERTION WAS COMPLETED, THE PT REPORTED SHORTNESS OF BREATH AND A FEELING OF FULLNESS IN HIS CHEST. PT WAS PLACED ON A CARDIAC MONITOR (BRADYCARDIA). PT TOLD CLINICIAN THAT HEART RATE NORMALLY RUNS LOW. OXYGEN WAS APPLIED VIA NASAL CANNULA. SAO2 WAS 95%. RESPIRATORY RATE WAS 18-20. PHYSICIAN  WHO SAW THE PT RECOMMENDED THAT THE DEVICE BE REMOVED. CLINICIAN DID NOT WANT TO REMOVE THE DEVICE BECAUSE OF THE DIFFICULTY INSERTING THE DEVICE. THE DEVICE WAS PULLED BACK 4 INCHES BECAUSE OF THE POSSIBILITY OF BEING IN THE RIGHT ATRIUM. PT GIVEN PO BENADRYL. EKG REVEALED SINUS BRADYCARDIA. A PERIPHERAL IV WAS INSERTED. WITHIN 15 MINUTES PT WALKED TO X-RAY TO CONFIRM PLACEMENT IN THE TOP OF THE SVC. THE DEVICE REMAINED IN PLACE.
DATE SENT TO FDA: 10/11/96. H2 JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MFR AND SALE OF THE STREAMLINE, LANDMAKS AND CENTERMARK BANDS OF I.V. CATHETERS AS OF 9/18/96.
ON 8/20/96, THE FACILITY'S OR MANAGER CONTACTED A MFR CUSTOMER SVC REP AND STATED THAT THEY WERE UNABLE TO ACCESS THE DEVICE AND AS A RESULT, THE SURGEON DECIDED TO EXPLANT THE DEVICE. THE FACILITY'S OR MANAGER ADDITIONALLY STATED THAT WHEN THE SURGEON WENT TO PULL OUT THE DEVICE CATHETER, THE CATHETER SHEARED. THREE(3) OR FOUR (4) INCHES OF THE DEVICE CATHETER REMAINED IMPLANTED IN THE PT. THE PT WAS THEN TRANSFERRED TO ANOTHER FACILITY TO COMPLETE THE EXPLANT OF THE REMAINING DEVICE CATHETER. THE PORTION OF THE DEVICE CATHETER AND THE DEVICE THAT WERE REMOVED WERE SENT ALONG WITH THE PT TO THE OTHER FACILITY. THE FACILITY'S OR MANAGER REQUESTED THAT ALL THE PIECES BE RETURNED TO BE EVALUATED BY THEIR LAB, AFTER WHICH, THE FACILITY WILL RETURN THE DEVICE AND THE PORTIONS OF THE DEVICE CATHETER TO THE MFR FOR ANALYSIS.
ON 10/01/96, A MFR REP CONTACTED THE FACILITY'S RISK MANAGER. THE FACILITY'S RISK MANAGER STATED THAT THE DEVICE AND PORTION OF THE DEVICE CATHETER THAT WAS REMOVED AT HER FACILITY AND SENT ALONG WITH THE PATIENT TO THE OTHER FACILITY WHEN THE PATIENT WAS TRANSFERRED FOR REMOVAL OF THE REMAINING SEGMENT OF CATHETER HAD SOMEHOW BEEN LOST/MISPLACED. THE FACILITY'S RISK MANAGER ALSO STATED THAT SHE REQUESTED THE OTHER FACILITY SEND A WRITTEN REPORT TO HER EXPLAINING THE LOSS/MISPLACEMENT OF THE DEVICE AND PORTION OF DEVICE CATHETER. THE MFR REP REQUESTED A COPY OF THIS REPORT WHEN RECEIVED. THE ONLY THING THAT WAS RETURNED TO HER FACILITY WAS THE BLUE SEGMENT OF CATHETER THE OTHER FACILITY REMOVED, APPROXIMATELY 4-5" IN LENGTH AND SHE WAS NOT SURE THAT THIS WOULD BE ENOUGH TO PERFORM AN ANALYSIS ON. THE MFR REP REQUESTED THAT THE SEGMENT OF BLUE CATHETER BE RETURNED TO THE MFR FOR ANALYSIS. THE DEVICE WAS RETURNED ON 10/7/96, AND IS PRESENTLY UNDERGOING ANALYSIS. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.
PT EXPERIENCED KNEE PAIN. REVISION SURGERY FOUND WEAR OF ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE ON TIBIAL INSERT'S ARTICULATING SURFACE.
NOTE: INFORMATION PROVIDED IN SECTION F WAS PROVIDED BY THE MFR, NOT THE USER FACILITY. THE DEVICE CANNOT BE EVALUATED SINCE THE SURGEON HAS NOTIFIED CO THAT THE DEVICE WILL NOT BE RETURNED TO US. THIS WAS NOTED IN CO'S ORIGINAL MEDWATCH REPORT.
CO WAS NOTIFIED BY ORTHOPAEDIC SURGEON OF REMOVAL OF BIPOLAR LINER AND BIPOLAR SHELL, SUBJECT OF 1219655-1996-00003, DUE TO DISLOCATION OF THE LINER AND SHELL FROM THE INNER FEMORAL HEAD.
THE ORIGINAL REPORT WAS INCORRECTLY FILLED OUT.
ON 8/19/96, THE MFR REC'D A COMPLAINT AND SUMMONS FROM THE PT'S ATTORNEY. THE COMPLAINT STATES THAT THE DEVICE WAS IMPLANTED ON 2/9/95 ON THE PT'S "RIGHT CHEST" TO ADMINISTER TREATMENT FOR HOGDKINS LYMPHOMA. ON 2/22/95, AND 3/8/95, THE PT REC'D TREATMENT AT A FACILITY THROUGH HER VEIN DUE TO TENDERNESS OF THE RIGHT CHEST AREA AND SOME DIFFICULTY ACCESSING THE DEVICE AND OBTAINING A BLOOD RETURN. ON 4/4/95, THE PT REC'D CHEMOTHERAPY AT WHICH TIME THE DEVICE WAS ACCESSED; HOWEVER, A BLOOD RETURN WAS NOT OBTAINED. ON 4/18/95, A DYE STUDY REVEALED A LEAK AND CHEMOTHERAPY WAS POSTPONED. ON 4/19/95, THE DEVICE WAS EXPLANTED AND THE DEVICE CATHETER COULD NOT BE EXTRACTED FROM THE VEIN. PART OF THE RIGHT COLLAR BONE WAS REMOVED TO EXTRACT THE DEVICE CATHETER.
ON 9/17/96, THE MFR LEGAL COUNSEL PROVIDED THE DEVICE CATALOG AND LOT NUMBERS. SEVERAL FACILITY NAMES WERE GIVEN IN THE ORIGINAL COMPLAINT & SUMMONS; HOWEVER, IT IS UNCLEAR WHICH FACILITY WOULD BE CONSIDERED THE USER FACILITY. THE LOCATION OF THE DEVICE IS NOT KNOWN AT THIS TIME; THEREFORE, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD FOR THIS CAT/LOT #. A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CAT/LOT NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. IN ADDITION, A REVIEW OF THE RECORD WAS PERFORMED ON THIS CAT/LOT # AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. BASED ON THE AVAILABLE INFO, AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. DUE TO THE LEGAL NATURE OF THIS REPORT, ALL FURTHER INVESTIGATION AND FOLLOW UP WILL BE CONDUCTED BY THE MFR LEGAL DEPT. SHOULD THE DEVICE BECOME AVAILABLE FOR ANALYSIS IN THE FUTURE, THE MFR WILL PROVIDE THIS INFO IN AN ADDITIONAL FOLLOW UP REPORT. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THE MFR IS NOW CLOSING ITS FILE ON THIS REPORT.
THE PT AWOKE ON 8/9 "FEELING WEIRD." AN 8:00/A FASTED READING ON HIS METER WAS 150MG/DL. AT 8:30/A, A HOSP LAB GLUCOSE RESULT OF 500 MG/DL WAS OBTAINED. THE PT WAS ADMITTED FOR HYPERGLYCEMIA, TREATED WITH INSULIN AND RELEASED THE FOLLOWING DAY. THE METER IS NOT CLEANED ACCORDING TO MANUFACTURER'S RECOMMENDATIONS, CONTROL SOLUTION IS USED TO CLEAN THE METER OBTICS. THE REPORTER STATED THAT THE OPTIC WINDOW LOOKS "OLD AND SCRATCHED." IN ADDITION, THE PT STORES THE TEST STRIPS OUTSIDE OF THE VIAL LOOSE IN THE METER CASE. THE METER WAS IN CALIBRATION ON 8/10, READING 79 VERSUS A RANGE OF 66-89.
H6 RESULT:  NO NON-CONFORMANCES.  CO IS UNABLE TO COMPLETE THEIR INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE DUE TO THE FACT THAT THE METER WAS NOT RETURNED TO LIFESCAN.  THEREFORE, CO HAS NOT BEEN ABLE TO EVALUATE THE METER TO DETERMINE WHETHER OR NOT A DEVICE MALFUNCITON MAY HAVE CONTRIBUTED TO THIS EVENT.  BATCH RECORD REVIEW INDICATES NO NON-CONFORMANCES IN THE MANUFACTURING PROCESS.  AT THIS POINT, CO CONSIDERS THIS MATTER CLOSED.  H6= BATCH RECORD REVIEW.
CO WAS NOTIFIED BY ORTHOPAEDIC SURGEON OF REMOVAL OF BIPOLAR SHELL AND BIPOLAR LINER, SUBJECT OF 1219655-1996-00002, DUE TO DISLOCATION OF THE SHELL AND LINER FROM THE INNER FEMORAL HEAD.
DEVICE WAS DIMENSIONALLY AND VISUALLY INSPECTED AND FOUND TO CONFORM TO SPECIFICATIONS. NO DEFECTS IN MATERIAL OR WORKMANSHIP WERE NOTED AND NO CONCLUSIONS AS TO THE CAUSE OF THE EVENT COULD BE ATTRIBUTED TO THE DEVICE AT THIS TIME. NOTE: INFORMATION PROVIDED IN SECTION F WAS PROVIDED BY CO, NOT THE USER FACILITY.
CORRECTED DATA FOR THIS REPORT IS AS FOLLOWS (FROM SECTION D6): PRODUCT CODE SHOULD BE: 85-8246. LOT NUMBER SHOULD BE: 55025. THE ORIGINAL REPORT WAS INCORRECTLY FILLED OUT.
THE PT'S RIGHT LEG WAS PINNED BETWEEN THE DETECTOR AND TABLE WHEN THE DETECTOR MOVED PAST ITS PROGRAMMED STOP POSITION WHILE THE SYSTEM WAS HOMING. MOTION WAS STOPPED BY THE MOTION ENCODER CIRCUIT. THE CAUSE OF THE CONTINUOUS MOTION IS UNCLEAR. ICE WAS APPLIED TO THE PT'S LEG; RADIOGRAPHS WERE NEGATIVE. THE PT WALKED OUT OF THE FACILITY UNDER HER OWN POWER. THE SYSTEM HAS BEEN MODIFIED WITH COLLISION SENSING HARDWARE AND CONTROL SOFTWARE/FIRMWARE.
A STUDENT TECH DROPPED A COLLIMATOR ON HER FOOT DURING A DETECTOR CHANGE OUT AND BROKE HER TOE. THE SITE HAD A 3RD PARTY SERVICER ADJUST THE COUNTERWEIGHTS TO BALANCE HEAVIER (NOT CO'S) COLLIMATORS. THIS CAUSED THE DETECTOR TO DRIFT UP DURING COLLIMATOR CHANGES. SVC READJUSTED THE COUNTERWEIGHTS TO FACTORY SPECS AFTER THE EVENT AND TOLD THE SITE NOT TO USE THE HEAVIER COLLIMATORS. THE SITE DID NOT FIND THIS ACCEPTABLE AND HAD SVC READJUST THE SYSTEM FOR THE HEAVIER COLLIMATORS. PRIOR TO THE EVENT, SVC HAD INFORMED THE SITE TO USE THE LOCKING PIN TO PREVENT THE DETECTOR DRIFT DURING COLLIMATOR CHANGE OUTS.
IN 11/95, AN ECHOCARDIOGRAM WAS PERFORMED WHICH SHOWED DECREASED FLOW ACROSS THE PROSTHETIC MITRAL VALVE. UROKINASE WAS GIVEN AT THAT TIME TO TREAT THROMBUS. THE PROCEDURE FAILED TO CORRECT THE SITUATION AND THE PT DIED. THIS VALVE WAS REMOVED AT AUTOPSY AND IS NOW BEING RETURNED FOR ANALYSIS. THROMBUS WAS PRESENT ON THE VALVE AT EXPLANT.
INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROTHESIS WHICH COMPLIED WITH CO SPECIFICATIONS AT THE TIME OF MFR. THE CO PHYSICIAN'S MANUAL RECOMMENDS THAT PATIENTS IMPLANTED WITH A CO MECHANICAL HEART VALVE BE ROUTINELY MAINTAINED ON ANTICOAGULANTS. THE CAUSE OF THE THROMBUS ON THIS VALVE MAY BE ASSOCIATED WITH NONCOMPLIANCE OR INTERRUPTION WITH THE PATIENT'S ANTICOAGULATION REGIME. THE MULTIPLE SURGERIES THE PATIENT HAD UNDERGONE OVER SUCH A BRIEF LENGTH OF TIME MAY HAVE COMPLICATED THIS REGIME. RESULTS OF THIS INVESTIGATION INDICATED THE LEAFLET IMMOBILITY DUE TO THROMBUS WAS NOT DUE TO INTRINSIC DEFECT IN THE VALVE. PAGES = 2.
THE VALVE WAS EXPLANTED DUE TO PARAVALVUALR LEAK. A 23MM MECHANICAL HEART VALVE HEMODYNAMIC PLUS SERIRES WAS THEN IMPLANTED. NO OTHER INFO IS AVAILABLE AT THIS TIME.
THE VALVE WAS RECEIVED IN CO'S ANALYSIS LAB. PRODUCT RETURN KIT, SUBMERGED IN A LIQUIED SOLUTION. THE SEWING CUFF WAS BROWNISH-WHITE IN COLOR, AND APPEARED TO COVER IN DRIED BLOOD. THE VALVE WAS CHEMICALLY STERILIZED AND FORWARDED TO DR FOR EVALUATION. THE VALVE'S GROSS MORPHOLOGY WAS ESSENTIALLY NORMAL. NO TISSUES COULD BE IDENTIGIED FOR FURTHER EXAMINATION. THE VALVE AND SEWING CUFF APPEARED  TO HAVE BEEN CLEANED, WHICH WAS MOST LIKELY DUE TO ITS SUBMERSION IN A FORMALIN SOLUTION. THE VALVE WAS THEN CLEANED, AND THE SEWING CUFF WAS REMOVED. THE VALVE WAS THEN VISUALLY EXAMINED AT 10X MAGNIFICATION FOR ANY ANOMALIES ON THE SURFACES OF THE LEAFLETS AND ORIFICE WERE FOUND TO BE UNREMARKABLE. THE VALVE WAS DISASSEBLED FOR PERFORMANCE TESTING. THE RESULTS OF THE PULSE DUPLICATEOR TESTING INDICATED THE VALVE HAD NO ABNORMAL OPERATION. FLOW AND PRESSURE TRACES INDICATED THE VALVE OPERATED SATISFACTORILY WITHOUT LEAFLET OR HYDRODYNAMIC MALFUNCTIONS. FUNCTIONAL LEAKAGE TESTING WAS PERFORMED, AND THE VALVE MET ALL OF CO'S SPECIFICATIONS. THE LEAFLET AND ORIFICE DIMESIONS WERE INSPECTED AND VERIFIED TO BE WITHIN CO'S SPECIFICATIONS. STERILIZATION VERIFICATION WAS COMPLETED BY THE CO'S MICROBIOLOTY DEPARTMENT. A REVIEW OF THE STERILIZATION PARAMETERS AND STERILIZER VALIDATIONS FROM THE PERIOD THAT ENCOMPASSES THE STERILIZATION DATE OF THIS VALVE WAS COMPLETED. THIS VALVE WAS STERILIZED IN ACCORDANCE WITH CO'S SPECIFICATIONS. THE VALVE'S DEVICE HISTORY RECORD WAS EXAMINED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE, INDICATING THAT THE PROCESS WAS PERFORMED IN ACCORDANCE WITH CO'S MEDICAL'S SPECIFICAIONS. EACH OPERAION FOR THE MANUFACTURING AND INSPECTION OF THIS VALVE WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE. INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE FER ANALYSIS LAB INDICATED  THIS VALVE WAS A NORMAL FUNCITIONING PROSTHESIS WHICH COMPLIED WITH CO'S MEDICAL SPECIFICATIONS AT THE TIME OF MFR. RESULTS OF THIS INVESTIGATION REMAIN INCONCLUSIVE DUE TO THE FACT THAT CO HAS OPERATIVE AND PATHOLOGY REPORTS. THE CAUSE OF PARAVALVULAR LEAK REMAINS UNK; TESTING PERFORMED AT THE CO INDCIATED IT WAS NOT DUE TO AN INTRINSIC VALVE DYSFUNCTION.
THE DEVICE WAS IMPLANTED IN 7/96 FOR INFUSION OF FUDR THROUGH THE HEPATIC ARTERY FOR TREATMENT OF CANCER. ON 8/30/96, THE FACILITY NURSE CONTACTED A MFR NURSE AND REPORTED THAT THREE WEEKS POST IMPLANT, THE DEVICE RAN DRY. THE DEVICE WAS THEN REFILLED, AFTER CHECKING NEEDLE PLACEMENT, AND THE SIDEPORT FLUSHED EASILY. ON 8/23/96, SEROUS FLUID WAS NOTED IN THE DEVICE POCKET. THE DEVICE WAS ACCESSED WITHOUT DIFFICULTY, FLOW RATE(FR)=4ML/DAY (PREDICTED FLOW RATE= 2.25ML/DAY). THE PT HAD A LOW GRADE FEVER AT THAT TIME. AT THE NEXT DEVICE REFILL ON 8/26/96, IT WAS NOTED THAT THE PT'S SKIN TONE WAS NORMAL AND THERE WAS MUCH SWELLING; HOWEVER, LESS THAN AT THE PREVIOUS REFILL ON 8/23/96. CLEAR SEROUS FLUID WAS ASPIRATED FROM THE DEVICE POCKET; HOWEVER, IT WAS NOT SENT FOR CULTURE. THE DEVICE WAS STILL FLOWING AT 4ML/DAY. ON 8/30/96, CLEAR SEROUS FLUID WAS ASPIRATED FROM THE DEVICE POCKET; HOWEVER, IT WAS NOT SENT FOR CULTURE. THE DEVICE WAS STILL FLOWING AT 4ML/DAY. ON 8/30/96, A LARGE AREA WAS NOTED EXTENDING TOWARD THE PT'S HIP WHICH WAS HARD IN AREAS AND HAD "A GREENISH BRUISING, LIKE AN OLD BRUISE". THERE HAD BEEN NO SKIN TEMPERATURE CHANGES AND NO NEW TRAUMA TO THE AREA. THE DEVICE FLOW RATE WAS NOW 3 ML/DAY. THE FACILITY NURSE STATED THAT THE PHYSICIAN WANTED TO BEGIN CHEMOTHERAPY ON TUESDAY, SEPT 3,96. THE MFR NURSE QUESTIONED IF THE DEVICE CATHETER HAD BEEN PUNCTURED WHEN THE DEVICE POCKET WAS ASPIRATED. SHE THEN STATED THAT IF THE AREA IS NOT IMPROVED BY 9/3/96, THEN IT WOULD BE NECESSARY TO PERFORM A DYE STUDY THROUGH THE DEVICE SIDEPORT. IF THE AREA IS NO WORSE AT THAT TIME, THEN THE PHYSICIAN COULD WAIT FOR THE 9/6/96 DEVICE REFILL TO MAKE A DECISION ABOUT THE SIDEPORT STUDY. THE MFR NURSE ALSO RECOMMENDED THAT ANY FURTHER ASPIRATE BE SENT FOR CULTURE.
ON 9/10/96 THE MFR NURSE ATTEMPTED TO CONTACT THE FACILITY NURSE WHO WAS THE ORIGINAL SOURCE OF INFO CONCERNING THIS PT/DEVICE; HOWEVER, SHE WAS INFORMED THAT THE NURSE WAS ON VACATION. THE MFR NURSE THEN SPOKE WITH ANOTHER FACILITY NURSE STATED THAT CHEMOTHERAPY HAS BEEN STARTED AND THE DEVICE FLOW RATE IS NOW 2.5 ML/DAY, WHICH IS NEAR THE PREDICTED FLOW RATE OF 2.25ML/DAY. THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS PART/SERIAL NUMBER AND NO MFG VARIANCES WERE IDENTIFIED. BASED ON THE AVAILABLE INFO, AND DUE TO THE UNAVIAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
IMPLANT PLACED ON 5/30/96, SITE #21. ABSCESS WAS DISCOVERED 7/12/96. IMPLANT WAS REMOVED. 2 OTHERS ARE STILL IN PLACE IN LOCATIONS #25 AND #27.
THE RETURNED IMPLANT WAS EVALUATED AND MEETS SPECIFICATINS. THE LIKELY CAUSE OF FAILURE IS REPORTED INFECTION COMPOUNDED BY THE PT'S SMOKING.
THE CLINICIAN INSERTED THE DEVICE IN THE FOREARM OF THE PT USING THE RECOMMENDED FLOAT IN TECHNIQUE. FIVE MINUTES AFTER THE INSERTION THE PT EXHIBITED FLUSHING, SHORTNESS OF BREATH AND AN INCREASE IN HEART RATE. SPECIFIC VITAL SIGNS WERE NOT AVAILABLE. THE DEVICE WAS IMMEDIATELY REMOVED. THE PT WAS GIVEN BENADRYL AND DID FINE. THE PT'S AIRWAY WAS NOT COMPROMISED AT ANY TIME.
CATHETER PLACED IN DOWNSTATE HOSP ON UNKNOWN DATE IN 1996. BROKE DURING REMOVAL. DISTAL END RETRIEVED BY RADIOLOGY, PERCUTANEOUSLY VIA RT GROIN FROM RIGHT ATRIUM/SUPERIOR VENA CAVA. REMOVED BECAUSE OF PERSISTENT INFECTION. PT HAD COMPLAINED OF FEELING MEDS INFUSED IN SUBCLAVIAN AREA. PER IV THERAPY, THIS MIGHT HAVE INDICATED A CRACK.
7/25/96; PT HAD CORNEAL MELT DURING PHACOEMULSIFICATION OF CATARACT LEFT EYE.
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT DUE TO INFECTION.
A DEVICE WAS INSERTED INTO THE PT LEFT ARM. ON THE 4TH DAY THAT THE CATHETER HAD BEEN IN PLACE, THE LEFT ARM BECAME RED, SWOLLEN AND TENDER. THE CATHETER WAS DISCONTINUED AND THE PT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF "PHLEBITIS/CELLULITIS OF LEFT ARM". THE PT WAS TREATED WITH INTRAVENOUS MEDICATIONS AND RELEASED HOME IN A FEW DAYS.
DATE SENT TO FDA: 10/11/96. H2--JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MFR AND SALE OF THE STREAMLINE, LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 9/18/96.
THE DEVICE WAS IMPLANTED FOR INTRATHECAL INFUSION FOR TREATMENT OF PAIN. ON 8/22/96, A FACILITY NURSE CONTACTED THE MFR'S CLINICAL REP AND STATED THAT THE EXPECTED FLOW RATE OF THE DEVICE IS 0.99 ML/DAY; HOWEVER, THE ACTUAL FLOW RATE OF THE DEVICE HAS BEEN 0.9ML/DAY. TODAY 8/22/96, THE RETURN VOLUME= 22CC, REFILL PERIOD=35 DAYS AND THE DEVICE FLOW RATE=0.8ML/DAY. THE PT HAS A PAST HISTORY OF A DEVICE CATHETER REVISION DUE TO DISPLACEMENT OF THE DEVICE CATHETER AND HAS BEEN COMPLAINING OF PAIN RECENTLY. THE PT'S MORPHINE DOSE WAS INCREASED FROM 3.5MG/DAY TO 4MG/DAY. THE FACILITY NURSE STATED THAT IN THE PAST THE PT COMPLAINED OF PAIN, THE DEVICE SIDEPORT WAS ASPIRATED AND THE FLUID OBTAINED TESTED POSITIVE FOR CEREBRAL SPINAL FLUID (CSF). THE MFR'S CLINICAL REP EXPLAINED THAT ASPIRATION OF EITHER OF THE DEVICE SEPTA IS NOT RECOMMENDED. THE MFR'S CLINICAL REP SUGGESTED THAT THE DEVICE SIDEPORT BE FLUSHED WITH NORMAL SALINE (NS) TO SEE IF IT FLUSHES EASILY AND QUESTIONED THE FACILITY NURSE AS TO WHETHER THIS PROCEDURE WOULD BE PERFORMED BY THE PHYSICIAN DUE TO A POSSIBLE BOLUS DOSE OF MORPHINE. ADDITIONALLY, THE MFR'S CLINICAL REP ALSO STATED THAT THE DEVICE SHOULD BE RINSED WITH TWO(2) 50CC SYRINGES OF PRESERVATIVE FREE NORMAL SALINE (PFNS) TO RID THE DEVICE SYSTEM OF AIR. IF RESISTANCE IS MET AND THE DEVICE FLOW RATE DOES NOT REVERT TO NORMAL, A DYE STUDY OF THE DEVICE SIDEPORT SHOULD BE PERFORMED. THE FACILITY NURSE STATED SHE WOULD TALK TO THE PHYSICIAN.
ON 9/25/96, THE FACILITY NURSE INFORMED THE MFR'S CLINICAL REP THAT DURING THE DEVICE REFILL ON 9/23/96, THE DEVICE YIELDED A FLOW RATE OF .8ML/DAY. THE EXPECTED FLOW RATE OF THE DEVICE IS .99ML/DAY AND THE DEVICE HAS BEEN FLOWING BETWEEN .8 AND .9ML/DAY. THE PATIENT'S MORPHINE DOSAGE WAS INCREASED TO 6.25MG/ML AND THE PATIENT WAS ADVISED TO CONTACT THE FACILITY IF SHE EXPERIENCED FURTHER PAIN. THE FACILITY NURSE STATED THAT THE PATIENT HAS NOT CALLED, SO SHE ASSUMES THAT THE PATIENT'S PAIN IS CONTROLLED. ON 10/2/96, THE MFR WAS INFORMED BY THE FACILITY NURSE THAT THERE ARE NO PLANS AT PRESENT TO EXPLANT THE DEVICE. THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN AND THE PATIENT'S MORPHINE DOSAGE WILL BE ADJUSTED ACCORDINGLY TO INCREASE THE PATIENT'S PAIN RELIEF. SINCE THE DEVICE REMAINS IMPLANTED, THE MFR'S INVESTIGATION OF THIS EVENT IS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT FOR THIS DEVICE. BASED ON THE INFORMATION AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE MFR'S INVESTIGATION OF THIS INCIDENT IS INCONCLUSIVE. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
EKG TECH WAS PERFORMING ECHOCARDIOGRAM OF PT WITH PREVIOUSLY IMPLANTED PACEMAKER. WHEN PART OF MACHINE TOUCHED PT'S BED, AN ARTIFACT RESEMBLING A PACEMAKER MALFUNCTION WAS REPRODUCED ON EKG STRIP. EKG PERFORMED ON PT AFTER TEST WAS IDENTICAL TO PRETEST EKG. CARDIOLOGIST FELT ABNORMAL EKG RESULT OF MALFUNCTION OF MACHINE AND WAS ARTIFACT ONLY. ECHOCARDIOGRAM MACHINE PART FELT TO BE CONTRIBUTING TO EVENT WAS REPLACED BY FACTORY SVC REP.
DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. UNABLE TO OBTAIN ADD'L INFO.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER HAD OR DAMAGE. TUBING HAD OR DAMAGE.
DURING PTCA AND STENT PLACEMENT, TIP OF GUIDEWIRE BROKE OFF, LODGING IN PERICARDIAL SPACE.
AFTER THE DEVICE HAD BEEN INDWELLING FOR 7 DAYS IN THE LEFT ANTECUBITAL AREA A RED STREAK DEVELOPED TO THE AXILLA. THE CATHETER WAS REMOVED, INFUSIONS STOPPED AND AN ORAL ANTIBIOTIC GIVEN. TWO DAYS LATER THE ARM WAS WORSE AND PT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF "PHLEBITIS/CELLULITIS LEFT UPPER ARM". THE PT WAS TREATED WITH INTRAVENOUS MEDICATION AND RELEASED HOME IN A FEW DAYS.
DATE SENT TO FDA: 10/11/96. H2- JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MFR AND SALE OF THE STREAMLINE, LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 9/18/96.
DURING ELECTIVE CIRCUMCISION OF ONE-DAY OLD BABY, TIP OF GLANS PENIS WITH MEATUS WAS ACCIDENTALLY AMPUTATED. UROLOGY AND PLASTIC SURGERY CONSULTS WERE OBTAINED IMMEDIATLEY. BABY WAS TAKEN TO SURGERY FOR RE-ATTACHMENT OF PENILE TISSUE AND REANASTOMOSIS OF THE URETHRA.
DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION AND EROSION. DATE NOT INDICATED. UNABLE TO OBTAIN ADD'L INFO.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDERS WERE FUNCTIONAL.
ADD'L INFO RECEIVED 10/27/97 ALSO INDICATES FLUID LOSS-CYLINDERS.
A 22 FR SILASTIC FOLEY WITH 5 CC BALLOON OPENED TO OR FIELD. PLACED IN PT BY DR. WHILE CLOSING PT IT WAS NOTED FOLEY CAME OUT. UPON REINFLATION, IT WAS NOTED THAT BALLOON HAS A SLOW LEAK OF STERILE FLUID, THEREFORE, DEFLATED. NEW 22 FR SILASTIC WITH 5CC BALLOON OPENED AND TESTED WITHOUT LEAKS. PT ABDOMEN RE-OPENED AND FOLEY PLACED BY DR. DR STATES "1ST FOLEY TESTED WITHOUT LEAKS."
IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW FRACTURED INSIDE AN IMPLANT. THE FRAGMENT WAS REMOVED SUCCESSFULLY. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
ON 8/19/96, THE FACILITY NURSE CONTACTED A MFR NURSE TO REPORT THAT DURING THE PT'S SECOND DEVICE REFILL, DEVICE ACCESS WAS UNEVENTFUL WITH A RETURN VOLUME OF 47ML. THE FACILITY NURSE REFILLED THE DEVICE WITH FUDR AND HEPARIN THEN ACCESSED THE DEVICE SIDEPORT. THE SIDEPORT WAS FOUND PATENT AND A 5 FU BOLUS WAS ADMINISTERED FOLLOWED BY A HEP-LOCK TO THE DEVICE SIDEPORT AND CATHETER. THE FACILITY NURSE REQUESTED ADVICE ON WHAT TO DO NEXT. THE MFR NURSE SUGGESTED THAT THEY FOLLOW THE DEVICE DECLOTTING PROCEDURE, DETAILED IN THE CLINICIAN'S MANUAEL, AND TO BRING THE PT BACK IN A FEW DAYS TO CHECK THE DEVICE FLOW RATE.
ON 09/19/96, THE MFR CLINICAL REPRESENTATIVE SPOKE WITH THE FACILITY NURSE CONCERNING THE LAST DEVICE REFILL. THE FACILITY NURSE STATED THAT THE DEVICE WAS LAST ACCESSED ON 09/09/96, AT WHICH TIME, THE DEVICE CENTER RESERVOIR WAS DRAINED OF FUDR AND INSTILLED WITH HEPARINIZED SALINE. ON 09/20/96, THE MFR'S CLINICAL REP CONTACTED THE MFR WITH FOLLOW UP INFO CONCERNING THIS DEVICE. THE FOLLOW UP REPORT STATES THAT ON 09/18/96, THE DEVICE WAS EXPLANTED. THE SURGEON DID NOT RECEIVE A RETURN VOLUME FROM THE DEVICE RESERVOIR. THE EXPLANTED DEVICE WAS SENT TO THE FACILITY RISK MANAGEMENT DEPARTMENT BEFORE BEING RETURNED TO THE MFR FOR ANALYSIS. ON 10/02/96, THE DEVICE WAS RETURNED TO THE MFR AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
A CUSTOM SURGICAL PACK WAS USED BY MEDICAL CTR. CAT# 50-8865.4. INSIDE THE PACK IS CAUTERY UNIT, THE CAUTERY UNIT WHEN USED ON THE SETTING COAGULATE, CUTS AND WHEN THE UNIT IS SET TO CUT IT COAGULATES.
IMPLANT PLACED ON 5/30/96, SITE #23. ABSCESS WAS DISCOVERED ON 7/12/96. THE IMPLANT WAS REMOVED. OTHER IMPLANTS ARE STILL IN PLACE IN LOCATIONS #25 AND #27.
RETURNED IMPLANT WAS EVALUATED. THE COLLAR AND HEX WERE DAMAGED DURING REMOVAL. THE CAUSE OF FAILURE WAS LIKELY THE REPORTED INFECTION, COMPOUNDED BY THE PT'S SMOKING.
CATHETER WAS NOTICED TO BE LEAKING. WHEN STAFF ATTEMPTED TO REPOSITION, PLASTIC SHEATH SEPARATED FROM HUB. PLASTIC SHEATH MIGRATED UP VEIN. DR ATTEMPTED TO RETRIEVE WITH NO RESULTS. PT WAS ADMITTED TO ICU. DR RETRIEVED SHEATH LATER THAT P.M.
WHILE PLACING A 4MM STENT DELIVERY SYSTEM, UPON INFLATION BALLOON DEVELOPED A LEAK, AS A RESULT THE PT HAD A SERIOUS AIR EMBOLISM AND WAS TRANSFERRED TO ICU. THE PT'S CONDITION UNK, WILL ASK.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED AN AXIALLY-DIRECTED TEAR. MICROSCOPIC EXAMINATION: FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS THAT MIGHT HAVE INITIATED THE TEAR. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
VASCULAR GRAFT (CATALOG #435022, AND BATCH #08071) WAS SUCCESSFULLY IMPLANTED OVER ONE YEAR AGO DURING THE FIRST STAGE OF A TWO PART SURGERY TO REPAIR A THORACIC AORTIC ANEURYSM. DURING THE SECOND (RE-INTERVENTION) STAGE OF THE SURGERY, AFTER THE GRAFT HAD BEEN IN SITU FOR OVER A YEAR, BLOOD LEAKED THROUGH THE GRAFT WALL WHEN THIS SECTION WAS MANIPULATED. THE PROCEDURE WAS COMPLETED AND THE PT RETURNED TO THE WARD. ONE WEEK LATER THE SURGEON REPORTED THAT THE PT DIED OF MULTIPLE ORGAN FAILURE.
THE FIRST STAGE OF THE PROCEDURE WAS PERFORMED ON 9/19/95 AND INVOLVED AN AORTIC VALVE REPLACEMENT, AORTIC ARCH REPLACEMENT, AND ELEPHANT'S TRUNK IMPLANT USING A GRAFT. THE PT DID NOT RECEIVE ANTI-COAGULATION BETWEEN THE TWO STAGES OF THE OPERATION WHICH OCCURRED NEARLY ONE YEAR AGO. CODE 300- THE SAMPLES OF THE GRAFT INCLUDE THE DISTAL ANASTOMOSIS, A PROXIMAL PORTION, AND MIDDLE PORTION OF THE GRAFT THAT WAS IMPLANTED NEARLY ONE YEAR BEFORE THE EVENT. THE THREE SAMPLES OF THE GRAFT GAVE THE APPEARANCE OF A GRAFT IN WHICH THERE WAS NO EVIDENCE OF ORGANIZATION IN THE GRAFT INTERSTICES, SIMILAR TO THE FEATURES SEEN IN VERY EARLY GRAFTS AFTER IMPLANTATION. THERE WAS NO EVIDENCE OF FLOW SURFACE DEVELOPMENT. THERE WAS NO EVIDENCE OF INFECTION IN THESE SAMPLES. A VASCULAR GRAFT WAS SUCCESSFULLY IMPLANTED ON 9/19/95 DURING THE FIRST STAGE OF A TWO PART SURGERY TO REPAIR A THORACIC AORTIC ANEURYSM. DURING THE SECOND (RE-INTERVENTION) STAGE OF THE SURGERY, AFTER THE GRAFT HAD BEEN IN SITU FOR NEARLY ONE YEAR, BLOOD LEAKED THROUGH THE GRAFT WALL WHEN THIS SECTION WAS MANIPULATED. THE PT WAS COOLED TO 17C AND THE PORTION OF THE GRAFT EXPERIENCING LEAKAGE WAS REMOVED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PT WAS RETURNED TO THE WARD. THE PT DIED 30 HOURS AND 43 MINUTES AFTER THE END OF THE PROCEDURE. THE CAUSE OF DEATH WAS LOW OUTPUT SYNDROME AND MULTI-ORGAN FAILURE.
DATE SENT TO FDA: 9/13/96. THE REPORTER STATES THAT THE MENTAL STATUS OF THE PT, I.E. COMBATIVENESS, AND THE USE OF WRIST RESTRAINTS MAY HAVE CONTRIBUTED TO THE EVENT. THE FACILITY DID NOT RETURN A SAMPLE FOR EVAL. THE USER REPORTS THAT THE PT WAS COMBATIVE AND THAT WRIST RESTRAINTS WERE IN USE WHILE THE DEVICE WAS IN PLACE. THE FACILITY REPORT STATES THAT THE USE OF RESTRAINTS AND THE COMBATIVENESS OF THE PT MAY HAVE CONTRIBUTED TO THE SEVERANCE. THE FACILITY WAS CONTACTED FOR FURTHER INFO AND REPORTED THAT A PORTION OF THE CATHETER TUBING REMAINED ATTACHED TO THE CATHETER HUB. IT HAS BEEN CO'S EXPERIENCE THAT WHEN A PORTION OF THE TUBING REMAINS ATTACHED TO THE HUB, THE SEVERANCE WILL HAVE BEEN CAUSED BY APPLICATION OF AN EXTERNAL CUTTING, PUNCTURING OR COMPRESSIVE FORCE. SEVERANCE CAN OCCUR WITH ANY INTRAVENOUS CATHETER WHEN IMPROPER PROCEDURES ARE EMPLOYED DURING USE OF THE DEVICE. DEVICE INSTRUCTIONS WHICH ACCOMPANY THE PRODUCT CAUTION AGAINST THE PRACTICE OF REINSERTING THE INTRODUCER NEEDLE DURING INSERTION OF THE DEVICE, AS THIS MAY PUNCTURE THE TUBING. THE DIRECTIONS ALSO CAUTION AGAINST THE USE OF SCISSORS DURING DRESSING CHANGES.
THE VALVE WAS REMOVED DUE TO MITRAL REGURGITATION. VALVE IMPLANT 163 MONTHS.
SUBMISSION OF INFO BY CO UNDER THE MFR REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CORRECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." H11. F10 CODES: PT CODE 1964-LABELED, #2376-LABELED. DEVICE CODE: 2320-LABELED. CONCLUSION CODE #68-DEVICE PERFORMED AS EXPECTED AND WAS RELATED TO THE REPORTED EVENT. G3 OTHER=THIS VALVE WAS RETURNED TO CO VIA ANOTHER CO, AT WHICH TIME CO CONTACTED THE MD FOR INFO. A MEDWATCH FORM WAS NOT RECEIVED FROM USER FACILITY THEREFORE, INFO WAS FILLED IN BY CO WITH INFO RECEIVED FROM THE MD. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE RPTR. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE RPTR, CO IS UNABLE TO COMPLETE FORM 3500A." THE ANALYSIS SHOWS THAT THE REGURGITATION APPEARS TO HAVE BEEN THE RESULT OF TISSUE DETERIORATION ASSOCIATED WITH MINERALIZATION. LARGE SECTIONS OF THE RIGHT AND LEFT CUSPS HAD BEEN REMOVED PRIOR TO CO RECEIPT OF THE VALVE. THIS MADE IT DIFFICULT TO PROVIDE A COMPLETE EVAL OF THE DEVICE.
PT ROLLED OUT OF BED AND ONTO THE FLOOR. SAME TYPE OF INCIDENT OCCURRED AGAIN ON 9/5/96, RESULTING IN ABRASIONS TO THE PT'S LEFT LEG.
FACILITY REPORTED THAT THERE WAS NOTHING WRONG WITH THE DEVICE, BUT SIDERAILS WERE NOT USED, WHICH IS CONTRARY TO INSTRUCTIONS. THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT INDEPENDENT VERIFICATIONS AS TO ITS ACCURACY. COMPLETENESS OR RELATIONSHIP TO THE PRODUCT. CO IS JUST RESPONDING TO THIS EVENT AS REQUIRED BY LAW.
THE RESIDENT WAS A TOTAL CARE, BED PT. HAD RECENTLY PLACED HIM ON AN AUTOMATIC PROGRAMMABLE PRESSURE RELIEF, ROTATION MATTRESS, AS A DECUBITIS PREVENTATIVE MEASURE. THEN ON 9/5/96, THE PT WAS FOUND WITH HIS HEAD THROUGH THE HALF BED RAIL. A CODE WAS STARTED AND CONTINUED UNTIL THE DR CALLED IT OFF. THE PT WAS PRONOUNCED DEAD. THE CAUSE OF DEATH WAS NOTED AS ASPHYXIA WITH AUTOPSY REPORT PENDING.
A BALLOON CATHETER WOULD NOT DEFLATE FOLLOWING THE INITIAL INFLATION DURING A DECLOTTING OF AN ARTERIOVENOUS FISTULA GRAFT PROCEDURE. A PERCUTANEOUS PUNCTURE WAS SUCCESSFULLY WITH THIS BALLOON CATHETER WITHOUT PT COMPLICATIONS. THE DEVICE WAS REC'D EVALUATED AND RETAINED BY THIS MFR. MICROSCOPIC EXAMINATION REVEALED A 1MM CIRCUMFERENTIAL TEAR LOCATED 6MM DISTAL TO THE PROXIMAL RO MARKER. CHATTER MARKS WERE NOTED ON THE BALLOON SURFACE. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH A SHARP EXTERNAL SOURCE, CHATTER ON THE BALLOON SURFACE. THEREFORE, CO BELIEVES THIS FACTOR CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE.
PT WENT INTO CARDIAC ARREST FOLLOWING IMPLANTATION OF SURGICAL BONE CEMENT. PT DIED ON OPERATING TABLE. DATE OF BIRTH: 5/30/98.
CORONARY PERFORATION DURING CARDIAC CATH PROCEDURE DUE TO APPARENT FRACTURE OF GUIDEWIRE RESULTING IN NEED FOR EMERGENCY BYPASS SURGERY FOR REMOVAL OF RETAINED GUIDEWIRE FRAGMENT.
PT HAD A HEMOMAPHY WITH MESH IN 1/96. POST OPERATIVELY THE PT HAD CHRONICALLY DRAINING SINUS. SURGERY ON 8/12/96 TO REMOVE THE MESH WHICH WAS FELT TO BE THE SOURCE OF INFECTION.
REASON FOR IMPLANTATION: INCISIONAL HERNIA. REASON FOR REMOVAL: DRAINING SINUS POSTOPERATIVELY. GROSS: THE SPECIMEN IS A PIECE OF GORE-TEX MYCROMESH BIOMATERIAL MEASURING 9.0 X 6.0 X .1 CM. THE SAMPLE HAS MULTIPLE SUTURE HOLES AROUND THE PERIPHERY OF THE IMPLANT. THERE ARE THREE ELONGATED CLEFTS MEASURING ABOUT 1 CM IN LENGTH (WITH CLEAN CUT EDGES) IN THE CENTRAL PORTION OF THE MYCROMESH BIOMATERIAL. THERE IS SOME TAN/GRAY, STRINGY, FIBROUS TISSUE ATTACHED PREDOMINANTELY TO ONE SURFACE. REP. SECTIONS WILL BE SUBMITTED IN CASSETTES 8-1596-8A THROUGH 8C. MICROSCOPIC: THE MYCROMESH BIOMATERIAL DEMONSTRATES MULTIFOCAL AREAS OF BLAND-APPEARING FIBROHISTIOCYTIC TISSUE ALONG BOTH SURFACES. IN AREAS, THERE IS PENETRATION INTO THE INTERSTICES BY SPINDLE SHAPED CELLS, PREDOMINANTLY FIBROBLASTS AND HISTIOCYTES WITH MILD TO A MODERATE AMOUNT OF INTERSTITIAL COLLAGEN DEPOSITION. THE INTERSTICES CONTAIN FOCAL AREAS OF GRANULAR EOSINOPHILIC PROTEINACEOUS MATERIAL WITH REGIONS, PREDOMINANTLY TOWARD ONE END OF THE IMPLANT, CONTAINING GRANULAR, BASOPHILIC, CELLULAR DEBRIS. AN OCCASIONAL NEUTROPHIL IS OBSERVED, BUT ACUTE INFLAMMATORY INFILTRATES, EITHER FOCAL OR DIFFUSE, ARE NOT OBSERVED. THERE IS NO MINERALIZATION AND MORPHOLOGICALLY INTACT BACTERIA ARE NOT OBSERVED. THE QUALITY OF FIXATION IS POOR. THE ERYTHROCYTES ARE PALE AND BULGING, NUCLEAR MORPHOLOGY AND CYTOPLASMIC STAINING IS SMUDGED. IMPRESSION: HISTOLOGY DOES NOT DEMONSTRATE MORPHOLOGICALLY INTACT BACTERIA OR ACUTE OR CHRONIC INFLAMMATORY INFILTRATES. THE MULTIFOCAL AREAS OF FIBROHISTIOCYTIC TISSUE WITH EXTENSION INTO THE INTERSTICES SUGGESTS THAT WOUND HEALING WAS PROGRESSING NORMALLY. THE PRESENCE OF NECROTIC CELLULAR DEBRIS, BASOPHILIC IN HUE IS HOWEVER, CONSISTENT WITH PRIOR BACTERIAL CONTAMINATION.
DURING TREATMENT WITH THE ATHERECTOMY SYSTEM, THE GUIDE WIRE APPARENTLY FRACTURED, A PERFORATION OCCURRED AND THE PT WAS SENT TO BYPASS SURGERY FOR REMOVAL OF THE GUIDE WIRE FRAGMENT.
THE PRODUCT WAS NOT RETURNED TO CO. THEREFORE, NO PRODUCT EVALUATION COULD BE PERFORMED. F1-: THE PT AND DEVICE CODES REPORTED ARE THE MOST APPROPRIATE TO THE INCIDENT DESCRIPTION. A COPY OF THE USER FACILITY REPORT IS ATTACHED FOR REFERENCE.
AN IV INFUSION OF 25,000 U OF HEPARIN IN 250CC OF D5W, THAT WAS ATTACHED TO CO'S IV PUMP, INFUSED INTO A PT IN APPROX 3 HRS. THE PUMP WAS SET TO INFUSE AT 8ML/HR. ONE HR AFTER THE EVENT, THE PT SUFFERED A CARDIAC ARREST AND DIED. PRIOR TO THE ARREST, SHE HAD BEEN FOLLOWING COMMANDS. THERE IS A QUESTION THAT THE PT HAD EXTENDED A CEREBRAL BLEED AS A RESULT OF THE HEPARIN OVERINFUSION. THE PTT WAS GREATER THAN 180 SECONDS. PROTAMINE WAS GIVEN TO REVERSE THE HEPARIN. PT HAD BEEN BLEEDING FROM NG TUBE PRIOR TO THIS EVENT.
CNA MAKING AFTERNOON ROUNDS, FOUND RESIDENT ROLLED OVER WITH FACE DOWN, RESIDENT WAS UNABLE TO MOVE FACE BECAUSE OF POSITION AND POSSIBLE POSITION OF MATTRESS OF SPECIALITY BED.
A 2 YR. OLD MALE HAD CIRCUMCISION, DUE TO BALANITIS WITH CONTRACTURE OF FORESKIN, USING A BELL MANUFACTURED BY CO. PT SEEN IN ER 5 DAYS LATER WITH PAIN, PENILE SWELLING, DYSURIA, HEMATURIA TREATED WITH ANTIBIOTIC AND PAIN MED. SEEN AGAIN IN ER ON 9/4/95, RING FELL OFF ON 9/3/95, HAS INCREASED SWELLING OF PENIS FORESKIN, PAIN ON URINATION, BROWN CRUSTING AND BRIGHT RED ERYTHEMA. TOLD TO CONTINUE ANTIBIOTIC, USE ICE BAGS. PT CONTINUED TO HAVE PAIN, SEEN IN FOLLOWUP BY SEVERAL PEDIATRIC AND UROLOGIC SPECIALISTS. MOTHER STATES PT HAS SIGNIFICANT EXCESS SKIN HANGING DOWN AS A RESULT OF THE ACUTE SWELLING, STATES PHYSICIAN HAS SAID THE CHILD MAY BE STERILE, MUST WAIT UNTIL CHILD REACHES PUBERTY TO DETERMINE; MAY ALSO NEED PLASTIC/COSMETIC SURGERY. PT IS NOW VERY FRIGHTENED OF DOCTORS/HOSPITALS.
EVAL SUMMARY: USER FACILITY REQUESTED RETURN OF DEVICE FOLLOWING MFR'S INSPECTION. REQUEST PRECLUDED EVAL PROCEDURES OTHER THAN VISUAL OBSERVATIONS. RESULTS: CODE 136-MATERIAL PROBLEM-POST PRODUCTION. BREAK IN PRODUCT AT THE POINT WHERE HANDLE CONTACTS THE BELL; SMALL PART OF PLASTIC MISSING. THIS DOES NOT APPEAR TO BE RELATED TO ANY SERIOUS INJURY. CODE 172-MFG-PROCESS. INCOMPLETE FILL THAT DOES NOT APPEAR TO BE RELATED TO ANY ADVERSE EVENT. CONCLUSIONS: CODE 48. DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT. USER FACILITY/EVENT CODES: CODE 1417-NOT IN LABELING. CODE 2371-NOT IN LABELING. CODE 2360-NOT IN LABELING. CODE 1387-LABELED. CODE 1069-NOT IN LABELING.
PT WAS ON TELEMETRY WITH ARRHYTHMIA CAPABILITIES, WHEN HE HAD AN ARREST. NO ASYSTOLE ALARM FROM SYSTEM EITHER DUE TO IMMEDIATE CLINICAL INTERVENTION BY CLINICAL STAFF OR POOR UTILIZATION OF ARRHYTHMIA COMPUTER SYSTEM. SYSTEM CHECKED BY INHOUSE BIOMED STAFF AND MFR AND FOUND TO BE FUNCTIONING CORRECTLY.
REPORT OF ALLEGED "PLATFORM DROPPED WITH USER ON IT RESULTING IN INJURIES TO USER."
H6. 86-DEVICE NOT RETURNED TO DATE FOR TESTING AND EVALUATION. H.6 68-SAME AS CODE 86. UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F.
A PT WAS SENT TO THE ER WHEN THE DEVICE COULD NOT BE REMOVED AT HOME AFTER THE COMPLETION OF THERAPY. HEAT WAS APPLIED UNSUCCESSFULLY. IN RADIOLOGY A GUIDE WIRE WAS INSERTED VIA FLUOROSCOPY. THE RADIOLOGIST WAS NOT ABLE TO REMOVE ANY LENGTH OF THE CATHETER. THE X-RAYS SHOWED THE CATHETER TO BE IN THE SUBCLAVIAN. THE PT STATED HE COULD FEEL "SOMETHING BUCKLING" IN THE BICEP AREA. A CUT DOWN WAS THEN DONE IN THE BICEP AREA AND THE CATHETER SUCCESSFULLY REMOVED. THE REPORTER STATES THAT THE SURGEON REPORTS, "THE CLEAR SILASTIC COATING WAS CRACKED ALL THE WAY AROUND. THERE WERE 2 LAYERS. FIBRIN HAD FORMED ALL AROUND AND INSIDE IT."
DATE SENT TO FDA: 9/13/96. B4,F8,G4-THIS IS MFR DATE. CODE #2357-NOT LABEL.
BOTH FALLOPIAN TUBES WERE TRANSECTED DURING LAPAROSCOPIC TUBAL BANDING USING 2ND HOLE BANDER. SURGEON THEN PERFORMED MINI-LAPAROTOMY TO RESECT TUBES AND THEN LIGATED BOTH TUBES.
THE VALVE WAS REMOVED DUE TO REGURGITATION AND STENOSIS. THROMBI FILLS THE OUTFLOW ASPECT OF THE CUSPS. IMPLANTED FOR 16 MONTHS.
SUBMISSION OF INFO BY CO UNDER THE MDR REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." NO MEDWATCH FORM WAS RECEIVED FROM THE FACILITY THEREFORE MEDTRONIC COMPLETED THIS FORM WITH INFO SUPPLIED BY THE HEALTHCARE PROFESSIONAL. H11. F10 CODES: PT CODE # 1716-LABELED, #1717-LABELED, #2101-LABELED. DEVICE CODES: 2320-LABELED. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A. THE ANALYSIS SHOWS THAT THE STENOSIS WAS THE RESULT OF THROMBUS THAT FILLS THE OUTFLOW ASPECT OF THE LEAFLETS. THE REGURGITATION WAS DUE TO A GAP BETWEEN THE LEFT AND RIGHT CUSPS AND THE PARTIAL RETRACTION OF THE NON-CORONARY CUSP WHICH WAS CAUSED BY THE THROMBUS. FOUR SMALL NATURAL FENESTRATIONS BELOW THE FREE MARGIN OF THE CUSP LEFT CUSP SIDE OF LEFT RIGHT COMMISSURE WERE WITHIN SPEC. TEARS AND ABRASION ON ALL SUPERIOR COAPTIVE AREAS APPEAR TO HAVE OCCURRED AT RETRIEVAL. THE RADIOGRAPH SHOWS THE VALVE TISSUE TO BE FREE OF MINERALIZATION.
DURING LAPAROSCOPIC TUBAL BANDING. SURGEON TRANSECTED LEFT FALLOPIAN TUBE WHILE TRYING TO APPLY THE BAND ONTO THE TUBE. MINILAPAROTOMY DONE TO RESECT THE TUBE AND LIGATE THE ENDS.
PT WAS DIAGNOSED WITH AN ESOPHAGEAL PERFORATION TWO HOURS AFTER UNDERGOING AN ACHALASIA PROCEDURE. AN X-RAY REVEALED AN ESOPHAGEAL PERFORATION AFTER THE PT EXPERIENCED CHEST PAIN TWO HOURS POST DILATION PROCEDURE. SURGICAL REPAIR OF THE ESOPHAGUS WAS UNEVENTFUL. THE PT'S CONDITION IS GOOD AND HAS SINCE BEEN DISCHARGED. THIS PRODUCT IS A REUSABLE DEVICE. RESTERILIZATION PROCESSES ARE RECOMMENDED IN CO'S DIRECTIONS FOR USE. THE NUMBER OF TIMES AND FREQUENCY THIS PRODUCT IS USED, AS WELL AS THE ACTUAL STERILIZATION PROCESS USED, IS AT THE DISCRETION OF THE USER. FOLLOW UP INDICATED THE PT'S CONDITION, RATHER THAN THE DEVICE, WAS A CONTRIBUTING FACTOR TO THIS EVENT. DUE TO THE NATURE OF THE LESION, A PEDIATRIC SCOPE WAS REQUIRED FOR CROSSING OF THE LESION IN THIS ADULT PT. INFO REGARDING BALLOON RUPTURE IS INCONCLUSIVE AT THIS TIME. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
H3-81 (AT THIS TIME, THE USER FACILITY CANNOT DETERMINE IF THE DEVICE HAS BEEN RETAINED OR DESTROYED). F10-2399-NOT LABELED. 2357- NOT LABELED. 1537-LABELED. 2203-PT'S LESION/ANATOMY MAY HAVE CONTRIBUTED TO BALLOON RUPTURE. THE DILATOR WAS SENT TO BIOMEDICAL ENGINEERING TO BE INVESTIGATED FOR POSSIBLE CAUSE OF THE ESOPHAGUS TEAR. THE BALLOON THAT WAS USED WAS RATED AT 20 PSIG (MAX). BIOMEDICAL ENGINEERING A Y-FITTING WAS PLACED BETWEEN THE DIAPHRAGM AND THE BALLOON ALLOWING A GAUGE TO BE PLACED MEASURING THE PRESSURE THE BALLOON WAS RECEIVING DIRECTLY. AT BOTH 10PSIG AND 20PSIG IT TRACKED VERY WELL. CONCLUSION: THE POSSIBLE REASONS FOR THE BALLOON TO BURST, ACCORDING TO THE MFR ARE OVERINFLATION OR THE POLYURETHANE OF THE BALLOON BECOMING WEAK. IN TALKING TO THE USERS OF THE DEVICE. THEY WERE UNCERTAIN HOW OFTEN THE BALLOON HAD BEEN STERILIZED. WITH THE GAUGE READING CORRECTLY. THE MOST PLAUSIBLE CAUSE FOR THE BALLOON TO BURST WAS AGE OF THE BALLOON. THE DIALATOR ASSEMBLY TESTED GOOD AND WAS ACCURATE BOTH OVER THE RANGE USED FOR THE PROCEDURE AND THE RANGE OF THE GUAGE (0-100PSIG). RECOMMENDATION: THE USERS OF THE DEVICE SHOULD CONTACT THE MFR TO GET INFO REGARDING THE NUMBER OF STERILIZATIONS THE BALLOON CAN HANDLE AND NOT EXHIBIT DEGRADATION OF THE POLYURETHANE.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED NO VISUAL ANOMALIES. FUNCTIONAL TESTING: THE BALLOON WAS PRESSURIZED WITH WATER, WHICH REVEALED THE PRESENCE OF A PINHOLE-TYPE LEAK SOURCE, 1.4 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAMINATION: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING THE TEAR EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON TEAR COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
NO SAMPLE RETURNED. CO HAS ADVISED THE HOSP TO RETAIN SAMPLES SHOULD THIS RECUR. CANNOT CONFIRM OR DUPLICATE THE REPORTED EVENT.
THE SUTURE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE NEEDLE BROKE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A DIALYSIS TREATMENT, THE ARTERIAL VENOUS PRESSURES WERE NOTED AS BEING LOW. TREATMENT WAS TERMINATED AND CONTINUED ON ANOTHER MACHINE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE FACILITIES BIOMED FOUND A BROKEN BLOOD PUMP ROTOR SPRING AND REPLACED IT WITH A NEW ROTOR. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT THE SPRING BROKE IN FIVE PIECES, BUT IT DID NOT FRAGMENT. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW. THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND/OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATMOSPHERIC PRESSURE. THIS ALARM GENERATES A VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE LOW ARTERIAL AND VENOUS PRESSURES WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960018. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
THE SUTURE WAS USED DURING A LUMBAR LAMINECTOMY PROCEDURE. REPORTEDLY, SUTURE WAS  "WICKING" AT THE TAILS. THE SURGEON TREATED THE INFECTION WITH TOPICAL ANTIBIOTICS. THE CLINICAL SUTURE WAS NOT RETURNED.
12/05/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D7, D8 AND D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN B4 AND F8.
THREE AND ONE HALF HRS INTO A HEMODIALYSIS TREATMENT THE PT EXPERIENCED A CARDIAC ARREST AND DIED. SHE WAS DIALYZING ON A ZERO POTASSIUM BATH. HER LAST POTASSIUM LEVEL ON 3/5 WAS 6.0. SHE HAD BEEN SUBSEQUENTLY PLACED ON A POTASSIUM RESTRICTED DIET AND HAD 2 LAXATIVES THE EVENING PREVIOUS TO THIS EVENT. THE MACHINE WAS CHECKED FOR FUNCTIONING AND FOUND TO HAVE DISCREPANCIES IN DIALYSATE AND BLOOD FLOW RATES AS WELL AS BLOOD LEAK DETECTOR. THE MFR WAS CALLED TO CHECK OUT THIS MACHINE. DFR AT 875 CC/MIN NOT 700 CC AS SET. BRF = "OK". FACILITY TECH FOUND 620 AT 300 SETTING. BLD LEAK DET TESTS AT 120 O'CLOCK. SHOULD BE AT 9 O'CLOCK.
THE SUTURE WAS USED DURING A LUMBAR LAMINECTOMY PROCEDURE. REPORTEDLY, SUTURE WAS "WICKING" AT THE TAILS. THE SURGEON TREATED THE INFECTION WITH TOPICAL ANTIBIOTICS. THE CLINICAL SUTURE WAS NOT RETURNED.
CLAMP BROKE AT TIP DURING USE - PROCEDURE WAS NEAR THE COMPLETION. PIECES WERE LOCATED AND REMOVED. X-RAY WAS TAKEN. NO METAL WAS SEEN IN ABDOMEN.
CATHETER WAS INSERTED IN PREMATURE INFANT ON 8/24/96. CATHETER WAS NOTED TO BE LEAKING FLUIDS WITHIN NEXT 12-24 HRS, AND REPLACEMENT OF CATHETER WAS REQUIRED. AT TIME OF REPLACEMENT, CATHETER WAS FOUND TO HAVE A SLIT IN IT. BABY WAS RECEIVING TPN AND LIPIDS. POTENTIAL FOR MULTIPLE PROBLEMS, INCLUDING PNEUMOTHORAX OR HEMOTHORAX HAD PROBLEM CONTINUED FOR AN EXTENDED PERIOD.
DURING A DIALYSIS TREATMENT, THE ARTERIAL VENOUS PRESSURES WERE NOTED AS BEING LOW. TREATMENT WAS TERMINATED AND CONTINUED ON ANOTHER MACHINE.  THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE FACILITY'S BIOMED FOUND A BROKEN BLOOD PUMP ROTOR SPRING AND REPLACED IT WITH A NEW ROTOR. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT THE SPRING BROKE IN THREE PIECES. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW. THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND/OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATMOSPHERIC PRESSURE. THIS ALARM GENERATES A VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE LOW ARTERIAL AND VENOUS PRESSURE WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960018. CUSTOMER CONTATED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
DURING ROUTINE T&A PROCEDURE WHERE CAUTERIZATION WAS USED, CHILD DEVELOPED A BURN INJURY TO THE CORNER OF THE MOUTH. A DEFECT IN THE PLASTIC CAUTERY PENCIL WAS NOTED AFTER THE PROCEDURE.
RESIDENT WAS BEING TRANSFERRED FROM HER BED TO HER WHEELCHAIR (MOTORIZED) WITH THE LIFT MFG BY CO, WHEN THE SLING SHE WAS IN, BROKE, CAUSING THE RESIDENT TO FALL TO THE FLOOR AND GETTING AN ABRASION TO THE BACK OF HER HEAD.
THE SUTURE WAS USED DURING A PELVIC EXENERATION. REPORTEDLY, THE SUTURE BROKE WHEN REMOVED FROM THE PACKAGE. THE HOSPTIAL HAS REPORTED NO PT INJURY OCCURRED.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE NEGATIVE PRESSURE CONTROLLER. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPG HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE SINCE THE TRACEABILITY PRE-DATES THE DATABASE. THE NEGATIVE PRESSURE CONTROLLER MET ALL MFG SPECIFICATIONS. THERE WAS NO FURTHER TESTING DONE ON THE NEGATIVE PRESSURE CONTROLLER SINCE ITS OPERATION IS NOT AFFECTED BY TEMPERATURE OR POWER CYCLING. THE RETURNED NEGATIVE PRESSURE CONTROLLER MET MFG SPECIFICATIONS. THE CAUSE OF THE REPORTED INCIDENT WAS MOST LIKELY THE FACILITY'S FAILURE TO CORRECTLY SET THE UF RATE ON THE MACHINE. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED  BY INVESTIGATOR: N. TRAINING REQUIRED: N.
RESIDENT WAS BEING TRANSFERRED FROM BED TO WHEELCHAIR VIA HOYER LIFT. AS RESIDENT WAS IN AIR BEING TRANSFERRED WITH THE HELP OF TWO STAFF MEMBERS, THE LIFT EVIDENTLY TILTED, THE HOYER LEGS CAME TOGETHER, AND THE RESIDENT WAS EASED TO THE FLOOR. THE MANUAL LEVER ON THE HOYER SEEMED TO HAVE MALFUNCTIONED, CAUSING THE HOYER TO BECOME OFF-BALANCE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. DATE DEVICE EXPIRES: 3/31/2001.
510K #950928. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICELI LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTRECTOMY PROCEDURE. REPORTEDLY, THE COMPLETE STAPLE LINE WAS NOT FORMED. THE SURGEON PLACED MANUAL SUTURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
HOSP SUBMITS THE FOLLOWING REPORT PURSUANT TO 21 CFR PART 803. THIS REPORT IS BASED ON INFORMATION REVIEWED BY HOSP WHICH HOSP MAY NOT HAVE HAD AN OPPORTUNITY TO INVESTIGATE FULLY OR VERIFY PRIOR TO THE REPORTING DATE. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY HOSP THAT IT ON ANY OF ITS EMPLOYEES OR AFFILIATES CAUSED OR CONTRIBUTED TO THE INCIDENT DESCRIBED HEREIN. PT WAS UNDERGOING ELECTRO-PHYSIOLOGY STUDY. WAS DEFIBBED THREE TIMES WHEN A BURNING SMELL WAS NOTED. PT WAS TURNED TO CHANGE THE PADS AND A BURN AREA ON THE EDGE OF BACK PAD AND WIRE WAS NOTED AS WELL AS A BURN TO PT'S MID BACK WHERE PAD WAS. BURN AREA TREATED WITH SILVADINE CREAM.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CAUTERIZING TIP OF THE INSTRUMENT BROKE OFF INSIDE THE PT. THE TIP WAS RETRIEVED DURING THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
PT RETURNED TO OR STATUS POST ENUCLEATION WITH 20 MM POLYETHYLENE IMPLANT OS ON 8/2/96. DIAGNOSIS OF EXTRUDING ORBITAL IMPLANT OS REQUIRING REPLACEMENT WITH A 15 MM SILICONE IMPLANT AND WOUND REVISION.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT LOAD INTO THE JAWS PROPERLY. THE HOSPITAL HAS REPORTED NO PT INJURY. DATE DEVICE EXPIRES: 4/30/2001.
1/29/97-SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. ADDITIONAL DATA ENTERED IN D7, D8, D9 AND E1. (ADDRESS & PHONE#).
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. DATE DEVCIE EXPIRES: 7/31/2001.
NEW RADIAL EDGE BIOPSY FORCEP USED DURING BRONCHOSCOPY. FORCEP TOOK LARGER SPECIMEN THAN PREVIOUS FORCEP USED BY THE PHYSICIAN. PT HAD PNEUMOTHORAX POST PROCEDURE. PHYSICIAN ASKED NURSE TO CALL MFR AND INSTRUMENT WAS RETURNED TO THEM. SO, THE LOT # AND EXPIRATION DATE ARE UNKNOWN. THE WRITER OF THIS REPORT WAS NOT NOTIFIED OF THE OCCURRENCE UNTIL A LETTER WAS RECEIVED FROM THE MFR ON 8/28/96.
THE DEVICE WAS APPLIED DURING A THORACOSCOPIC GIANT BULLECTOMY PROCEDURE. REPORTEDLY, THE JAWS DID NOT OPEN READILY. THE SURGEON OPENED THEM WITH FORCEPS. THE HOSPITAL HAS REPORTED NO PT INJURY. DATE DEVICE EXPIRES: 6/30/2001.
10/28/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA BY MFG. ADDITIONAL DATA ENTERED IN D7, D8, D9, E1, F3, F5 AND H4. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA SUBMITTED FOR B4 AND F8.
LEAK NOTED DURING PRIME, BUT PT CONDITION NECESSITATED BEING PLACED ON BYPASS OXYGENATOR WAS UNABLE TO REMAIN ON BYPASS DUE TO LEAK. DECISION WAS MADE TO SWITCH OUT OXYGENATOR.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. REPORTEDY, THE INSTRUMENT DID NOT FIRE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
A2 AND A4 INFO REQUESTED BUT NOT PROVIDED BY HOSP. SECTION F PROVIDED BY MFR. SECTION F10:PT CODE NOT 1802. CORRECT CODE IS 2202. F10: DEVICE CODE 1316-LABELED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE SPINAL NEEDLE WAS BENT AS IT WAS PUSHED AGAINST THE BONE. WHEN THE SPINAL NEEDLE WAS PARTIALLY WITHDRAWN THROUGH THE INTRODUCER IN AN ATTEMPT TO REALIGN THE POSITION, IT IS SUSPECTED THAT IT SNAGGED ON THE TIP OF THE INTRODUCER AT THE SPOT WHERE IT HAD BENT. THE WHOLE ASSEMBLY WAS THEN WITHDRAWN, AND AS THE DISTAL FRAGMENT IS LYING SUPERFICIAL TO THE SPINOUS PROCESS, IT IS EXPECTED THAT IT WAS AT THIS TIME THAT THE NEEDLE FINALLY BROKE. AFTER THIS, THE ANESTHETIST NOTED THAT THE SPINAL NEEDLE WAS SHORTER, WITH THE STYLETTE PROTRUDING 2 CM THROUGH THE BROKEN END. THE STYLET WAS THEN WITHDRAWN AND BECAME TWISTED AND BROKEN IN THE PROCESS.
THE PHOTOS INDICATE THAT THE SAMPLE NEEDLE WAS BENT DURING THE PROCEDURE AND SHEARED IN TWO. THIS HAS BEEN CONFIRMED BY THE HEALTHCARE PROFESSIONAL(SEE ATTACHED COMPLAINT SHEET)AND BY THE CORPORATE MICROSCOPY LAB WHO HAVE PROVIDED THE PHOTOS.
DURING RESECTION OF BILATERAL HAGLIN'S DEFORMITY, SURGEON LEANED ON ELECTROSURGICAL PENCIL THUS ACTIVATING IT. PENCIL BURNED THROUGH SURGICAL DRAPE AND BURNED PT'S POSTERIOR THIGH (R) ABOVE POPLITEAL SPACE. BURN WAS APPROX 2-3 CM LONG AND 1-2 CM DEEP. ANOTHER SURGEON (GENERAL SURGEON) WAS CALLED TO CONSULT. AREA WAS REPREPPED AND DRAPED. BURNED AREA WAS EXCISED AND SKIN STITCHED CLOSED. DRY STERILE DRESSING APPLIED.
THE SUTURE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE NEEDLE BROKE. THE DISENGAGED PIECE WAS SUCCESSFULLY REMOVED FROM THE PT. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
PT WENT INTO VT AFTER 2X SHOCKS, DEVICE WENT TO CONTINUOUS TONE. DEVICE FAILED TO TREAT VT IN PT. ALSO PACER SECTION DEVICE WOULD NOT RESPOND TO TELEMETRY WAND. DEVICE EXPLANTED.
X-TUBE ASSM 1/" X 16". DEALER CLAIMS THE X-TUBE BROKE.
THE PRODUCT WAS APPLIED DURING AN UNSPECIFIED ABDOMINAL PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SUTURE BROKE. THE SURGEON USED ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 8/1/96. PATIENT'S CURRENT STATUS: DOING FINE - RPT'D 8/1/96.
PT UNDERWENT CATARACT SURGERY ON 8/20/96, IMPLANTATION OF INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON NOTED THAT THE LENS DID NOT EJECT IN A CONTROLLED MANNER, CAUSING IT TO FLIP OVER DURING INSERTION. THE SURGEON NOTICED A POSTERIOR CAPSULE TEAR PRIOR TO LENS INSERTION AND AN ANTERIOR VITRECTOMY WAS PERFORMED.
H6-CONCLUSION CODE-THE DAMAGE TO THIS LENS MAY HAVE OCCURRED IF THE INJECTOR PLUNGER RODE OVER THE OPTIC DURING INSERTION. THE LENS MUST BE INCARCERATED FOR THIS TO OCCUR. THE LENS WAS MOST LIKELY UNDER LUBRICATED OR MISALIGNED IN THE CARTRIDGE LOADING AREA (SEE ATTACHED EVALUATION). SEVERAL ATTEMPTS TO CONTACT THE SURGEON FOR FOLLOW-UP INFO WAS MADE. HOWEVER, THE SURGEON WAS NOT COOPERATIVE & HE WOULD NOT SUPPLY ANY INFO. THE RATE OF OCCURRENCE OF THIS EVENT CANNOT BE DETERMINED AS IT IS NOT ADDRESSED IN THE PRODUCT LABELING. LENS BOX WAS RECEIVED. THE BOX CONTAINED THE PT ID CARD, REGISTRATION CARD, AND PLASTIC BAG. THE BAG CONTAINED TWO CARTRIDGE TRAYS, THE LENS TRAY, AND 2 MODEL MTC-45S (BOTH FROM L/N CS0492) INJECTOR CARTRIDGES. THE LENS TRAY CONTAINED THE BASE INSERT, WITH THE LENS LOCATED UNDER THE INSERT. TAPE WAS HOLDING THE LENS AND INSERT TO THE TRAY. THE LENS WAS REMOVED FROM THE TRAY AND INSPECTED FOR GENERAL DEFECTS. THE LENS HAS DRIED BLOOD AND BSS/VISCOELASTIC RESIDUE. A PORTION OF THE OPTIC, INCLUDING A HAPTIC, WAS MISSING. ONE CARTRIDGE WAS REMOVED FROM THE BAG AND INSPECTED FOR GENERAL DEFECTS. THE CARTRIDGE HAS DRIED BSS/VISCOELASTIC RESIDUE IN THE LOADING AREA AND BARREL. A PORTION OF THE TIP IS BENT OUTWARDS. NO TEARS ARE PRESENT ON THIS INJECTOR CARTRIDGE. THE REMAINING CARTRIDGE WAS REMOVED FROM THE BAG AND INSPECTED FOR GENERAL DEFECT. THE CARTRIDGE HAS DRIED BSS/VISCOELASTIC RESIDUE IN THE LOADING AREA AND BARREL. NO TEARS ARE PRESENT ON THIS INJECTOR CARTRIDGE. THE DAMAGE TO THIS LENS MAY HAVE OCCURRED IF THE INJECTOR PLUNGER RODE OVER THE OPTIC DURING INSERTION. THE LENS MUST BE INCARCERATED FOR THIS TO OCCUR. THE LENS WAS MOST LIKELY UNDER LUBRICATED OR MISALIGNED IN THE CARTRIDGED LOADING AREA.
X-TUBE ASSM 18" X 19" DEALER CLAIMS X-TUBE BROKE BUT DOESN'T KNOW THE EXACT LOCATION.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
SURGICAL ADMISSION FOR UNDESCENDED TESTICLE AND PHIMOSIS. UROLOGY SURGEON PERFORMED RIGHT INGUINAL HERNIORRHAPHY, RIGHT ORCHIECTOMY, AND CIRCUMCISION. PT WAS READMITTED BECAUSE OF CLEAR YELLOW FLUID DRAINING FROM THE WOUND. SURGICAL INTERVENTION REQUIRED FOR REPAIR OF BLADDER PERFORATION AND REPAIR OF RIGHT INGUINAL FLOOR. SURGEON THINKS THAT WHEN HE WAS DISSECTING AND LOOKING FOR THE TESTICLE, THE BOVIE TIP MUST HAVE TOUCHED THE BLADDER.
10/28/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA BY MFG. ADDITIONAL DATA ENTERED IN D7, D8 AND D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA SUBMITTED FOR B4 AND F8.
X-TUBE ASSM 18" X 16" DELAER CLAIMS X-TUBE BROKE AT THE BOLT HOLE ON BOTH SIDES. THE USER STATED IT JUST BROKE AS SHE WAS WHEELING TO WORK.
REPORT OF ALLEGED "PT STATED VENTILATOR WAS ALARMING SETTING ERROR AND SHUTTING OFF AND THEN WOULD COME BACK ON. NO PT HARM."
H.3. TESTING BY MFR FOUND DEVICE FULLY, FUNCTIONAL. EVIDENCE OF LIQUID SPILL. LABELING #1738.
MAMMARY IMPLANTS FROM 1989. PT WITH MASS IN RIGHT BREAST. NEEDLE BIOPSY SHOWS SILICONE GRANULOMA OF RIGHT BREAT AND CAPSULE. LEFT BREAST HAS CAPSULE. BOTH IMPLANTS WERE RUPTURED.
X-TUBE ASSM 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE BOLT HOLE ONLY ON ONE SIDE. BROKE WHILE IN THE OFFICE AT WORK.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
UPON INSERTION OF A #20 CATHETER, AFTER BEING UNABLE TO ADVANCE CATHETER AND WHILE PULLING CATHETER OUT, CATHETER BROKE OFF WHILE STILL IN PT'S ARM. THIS WAS REPORTED IMMEDIATELY TO THE MEDICAL DIR. PT PLACED ON OR TABLE, CUT DOWN PERFORMED AND IV CATHETER REMOVED FROM PT'S VEIN.
REPORT OF ALLEGED "PRESSURE LIMIT CONTROL VALVE STICKS, UNIT ALARMED. NO PT HARM."
LABELING - 1738. H.3. TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL.
THE DEVICE WAS APPLIED DURING A LUNG RESECTION PROCEDURE. THE INSTRUMENT COULD NOT BE CLOSED AFTER FIRING. THE SURGEON REMOVED THE INSTRUMENT WITHOUT INCIDENT.
10/28/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA BY MFG. ADDITIONAL DATA ENTERED IN D7, D8 AND D9. DEVICE EVALUATION INDICATED AND CODES ENTRED IN H3 AND H6.
REPORT RECEIVED FROM EUROPEAN OPERATIONS INDICATED THAT , DURING CLINICAL USE, THE BALLOON BURST AT 2 ATMS, USING ANOTHER CO'S MANOMETER AND 50/50 SOLUTION OF CONTRAST MEDIUM/NACL. THERE WAS NO REORT OF PT INJURY OR COMPLICATIONS. THE PRODUCT HAS BEEN RETURNED TO CO FOR EVAL AND TESTING, HOWEVER, THE ENGINEERING EVAL IS NOT YET COMPLETE. PLEASE NOTE DATE OF 10/17/96, FOR SUBMISSION OF SUCH INFO PENDING COMPLETION OF THE ANALYSIS.
BALLOON BURST AT 2 ATM, PRESSURE MANOMETER (ANOTHER CO'S) WAS USED. CONTRAST MEDIUM/NACL 50/50.
RIGHT SILICONE IMPLANT OF 11-15 YRS IMPLANT HISTORY REMOVED UPON ADVICE OF MD DUE TO COMPLAINTS OF FATIGUE, MUSCLE ACHING, AND JOINT PAIN. PT HAD MASTOPEXY IN 1986-88. PT HAD COMPLAINTS OF FIBROMALGIA AND MACROMASTIA SO BILATERAL OPEN CAPSULECTOMY AND REMOVAL OF SILICONE IMPLANTS WITH MASTAXTOMY. NOTATION OF LOSS OF ROUND SHAPE WHICH HAD SUGGESTED DISINTEGRATION OF MEMBRANE. PTOSIS OF BREASTS ALSO NOTED.
REAL S/F DA PNTDR Q2. THE DEALER ALLEGES THE RIGHT REAR SIDE FRAME BROKE.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ,ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
RIGHT SILICONE IMPLANT OF 11-15 YRS IMPLANT HISTORY REMOVED UPON ADVICE OF MD DUE TO COMPLAINTS OF FATIGUE, MUSCLE ACHING, AND JOINT PAIN. PT HAD MASTOPEXY IN 1986-88. PT HAD COMPLAINTS OF FIBROMALGIA AND MACROMASTIA SO BILATERAL OPEN CAPSULECTOMY AND REMOVAL OF SILICONE IMPLANTS WITH MASTEXTOMY. NOTATION OF LOSS OF ROUND SHAPE WHICH HAD SUGGESTED DISINTEGRATION OF MEMBRANE. PTOSIS OF BREASTS ALSO NOTED.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION ON 8/11/75. PLAINTIFF ALLEGES" PAIN AND PHYSICAL DISCOMFORT."
USER WAS PERFORMING A ROUTINE DAILY 100J TEST. USER ALLEGEDLY SUFFERED FROM ELECTRICAL SHOCK PERFORMING THE TEST WHILE THE PADDLES WERE IN THE POCKETS. NO VISUAL DAMAGE TO THE PADDLES. PADDLES ARE IN REVERSED POSITION (RIGHT PADDLE IN LEFT POCKET AND VICE VERSA). TOP COVER IS ONE OF THE MOUNTING STUDS. THE STUD WAS BROKEN AT THE LOCATION OF THE RIGHT HAND PADDLE POCKET. CALIBRATION IS GOOD. ROUTINE TEST IS GOOD. FIELD ENGINEER'S OPINION OF THE CAUSE: USER COULD HAVE TOUCHED THE METAL PARTS OF THE PADDLE ELECTRODES DURING TEST. 960827 FACTORY EVALUATION: ONLY THE EXTERNAL PADDLES WERE RETURNED FOR EVALUATION. INITIAL INSPECTION REVEALED NO DEFECTS. SUBSEQUENTLY HV TESTING SHOWED NO SIGN OF LEAKAGE AT 10 KV DC OR AT 6 KV AC. VOLTAGE WAS APPLIED BETWEEN EACH HV ELECTRODE AND FOIL FORMED AROUND ALL SURFACES OF THE HANDLES AREA OF THE PADDLES. ROOT CAUSE ANALYSIS: NO TROUBLE FOUND WITH THE PADDLE SET, INCLUDING HV INTEGRITY OF THE ISOLATION PROVIDED THE OPERATOR. 960827 FEEDBACK FORM FIELD ENGINEER ON BROKEN STUD: THIS APPEARS TO HAVE NOTHING TO DO WITH THE ALLEGED SHOCK EVENT. ORDERING A NEW TOP COVER TO BE INSTALLED BEFORE RETURNING THE UNIT TO THE CUSTOMER.
ONLY THE EXTERNAL PADDLES WERE RETURNED.
THE DEVICE WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON USED ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DROP TUBE WITH ATTACHED LIGHTS FELL OUT OF THE TROLLEY. IT WAS OBSERVED BY THE DR, THAT THE SET SCREWS HAD COME OUT OF THE TROLLEY.
THERE WAS NO INJURY SO THERE ARE NO PT CODES APPLICABLE TO THIS REPORT.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT HOLE LOCATION.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THA THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
IF FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING.? N. IS FREQUENCY GEATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U. 510K #950928.
TRIPLE LUMEN FOLEY CATHETER INSERTED INTO PT. APPROX 36 HRS LATER PT STATES SHE FELT A "POP." THE FOLEY CATHETER FELL OUT SPONTANEOUSLY. THE BALLOON PORTION WAS NOT VISUALIZED ON THE CATHETER AFTER IT FELL OUT. PT SUBSEQUENTLY EXPERIENCED A TRANSIENT HEMATURIA EPISODE AND REQUIRED A CYSTOSCOPY UNDER ANESTHESIA TO ASCERTAIN THE PRESENCE OF A RETAINED FOREIGN OBJECT IN THE BLADDER. NONE WAS FOUND. THERE WAS NO PERMANENT INJURY TO THIS PT. ROUTINE BLOODWORK AS PER CHEMOTHERAPY PROTOCOL.
X-TUBE ASSM 19" X 17" DEALER CLAIMS X-TUBE BROKE AT THE BOLT HOLE.
REPORT OF ALLEGED "UNIT STRUCK BY LIGHTNING. DOES NOT CYCLE. ALL LEDS NOT SURE OF ANY AUDIBLE ALARMS. NO PT HARM".
F.12) MFR NOT REQUIRED TO COMPLETE THIS SECTION AS NO MEDWATCH FORM 3500A WAS RECEIVED FROM USER/DISTIBUTOR.
THE REFLECTOR HEAD FELL DURING USE IN A PROCEDURE NARROWLY MISSING THE PT.
THERE WAS NO INJURY SO THERE ARE NO PT CODES THAT ARE APPLICABLE TO THIS REPORT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
BILATERAL SILICONE BREAST IMPLANTS FOUND TO BE RUPTURED UPON EXPLANTATION.
X-TUBE ASSM 18" X 15". DEALER CLAIMS X-TUBE BROKE AT THE BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, IT CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REPORT OF ALLEGED "VENTILATOR HAS CONSTANT ALARM IN ASSIST CONTROL, NO LIGHTS, DOESNT CYCLE".
F.12) MFR NOT REQUIRED TO COMPLETE THIS SECTION AS NO MEDWATCH FORM 3500A WAS RECEIVED FROM USER/DISTRIBUTOR.
DURING CODE 99, O2 TUBING BECAME DISCONNECTED AND PT DESATURATED. PT PLACED BACK ON VENT WHILE O2 TUBING RECONNECTED. PT WAS MANUALLY VENTILATED AGAIN AND SATURATION CONTINUED TO DROP, DESPITE O2 TUBING CONNECTION SECURED.
THE ADDITIONAL INFO SUBMITTED IN THIS REPORT WAS RECEIVED BY V.S.I. AFTER CO'S ORIGINAL SUBMISSION WAS MADE.
X-TUBE ASSM 18" X 16" DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO  OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 5/31/79, WITH EXPLANT 10/30/92. PLAINTIFF ALLEGES "INJURIES AS A RESULT OF IMPLANTS CONTAINING OR CONSISTING OF SILICONE, SILICONE GEL, AND/OR AN ELASTOMER MADE OF SILICONE."
DURING SERVICE OF PRODUCT AN INTERMITTENT APNEA ALARM WAS FOUND DUE TO INTEGRATED CIRCUIT U8 ON THE ANALOG BOARD BEING OUT OF SPECIFICATION. REPLACED U8.
F.10) MFR NOT REQUIRED TO COMPLETE THIS SECTION AS NO MEDWATCH FORM 3500A WAS RECEIVED FROM USER/DISTBRIBUTOR. H.10) MALFUNCTION FOUND DURING SERVICE OF DEVICE BY MFR. NOT IN PT USE.
QR AXLE NON-RECESS HUB W/NUT. DEALER CLAIMS THE BUTTON INSIDE CAME OUT OF THE AXLE AND DETEND BALLS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 1/3/80 WITH EXPLANT 1/18/96. PLAINTIFF ALLEGES "INJURIES AS A RESULT OF IMPLANTS CONTAINING OF CONSISTING OF SILICONE, SILICONE GEL, AND/OR AN ELASTOMER MADE OF SILICONE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE PHYSICIAN RETRACTED THE PROTECTIVE SHEATH AND INADVERTENTLY PREPPED THE SHEATH PORT INSTEAD OF THE BALLOON PORT WHICH LED THE PHYSICIAN TO BELIEVE THE DELIVERY BALLOON HAD RUPTURED. DURING WITHDRAWAL OF THE DELIVERY SYSTEM FROM THE PT'S BODY, THE STENT EMBOLIZED FROM THE DELIVERY BALLOON AS THE DEVICE WAS BEING WITHDRAWN THROUGH THE GUIDING CATHETER. THE EMBOLIZED STENT WAS RETRIEVED UTILIZING A SNARE WIRE AND ANOTHER CORONARY STENT WAS SUCCESSFULLY PLACED AT THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
X-TUBE ASSM 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE WELD.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION, OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, STAPLES DID NOT FIRED WHEN THE DEVICE WAS APPLIED.
BONE CEMENT WAS INSERTED. WITHIN SECONDS, BLOOD PRESSURE DROPPED FROM 150 SYSTOLIC TO 30 SYSTOLIC. SURGEON'S REPORT ALSO STATES BRADYCARDIA. VASOPRESSOR DRUGS WERE GIVEN WITHOUT SUCCESS. RESUSCITATION WAS CARRIED OUT FOR 55 MINUTES WITH NO RESULT.
THE PHYSICIAN EXPERIENCED DIFFICULTY IN ADVANCING A CORONARY STENT WITH DELIVERY SYSTEM THROUGH THE PT'S CIRCUMFLEX ARTERY. IT IS NOT CLEAR WHETHER THE PHYSICIAN PURPOSELY OR INADVERTENTLY RETRACTED THE PROTECTIVE SHEATH, WHICH SUBSEQUENTLY RESULTED IN THE STENT EMBOLIZING IN THE PT'S LEFT MAIN CORONARY ARTERY. ALTHOUGH BLOOD FLOW CONTINUED TO BE ADEQUATE, THE DECISION WAS MADE TO SEND THE PT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
DURING INSERTION THE IAB BALLOON COULD NOT BE INSERTED PAST THE PROXIMAL POINT. A REPLACEMENT BALLOON WAS INSERTED WITHOUT INCIDENT TO PT.
A TEMPORARY PULSE GENERATOR THAT WAS CONNECTED TO THE PT DID NOT CAPTURE. ANOTHER TEMPORARY PULSE GENERATOR WAS CONNECTED AND CAPTURED.
DURING INSERTION THE IAB COULD NOT BE INSERTED PAST THE PROXIMAL POINT. A REPLACEMENT BALLOON WAS INSERTED W/O INCIDENT TO PT.
H-10 ALL REQUESTED INFO WAS PROVIDED ON INITIAL REPORT.
EVALUATION RESULTS SUGGEST THAT THIS EVENT IS PT RELATED. THE PT SUFFERED AN ADVERSE REACTION TO THE PRODUCT. THIS ADVERSE REACTION IS WELL KNOWN AND DOCUMENTED WITHIN THE PRODUCT LITERATURE.
AN ENDOVASCULAR STENT EMBOLIZED DURING AN ATTEMPTED STENTING PROCEDURE TO THE PT'S SAPHENOUS VEIN GRAFT. THE EMBOLIZED STENT WAS RETRIEVED UTILIZING A SNARE WIRE. THE TARGET LESION SITE WAS TREATED WITH BALLOON ANGIOPLASTY. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THIS STENT IS NOT INDICATED FOR USE IN CORONARY OR VEIN GRAFT PROCEDURES.
DURING A PROCEDURE, A PIECE ON THE END OF A #5 TROCAR BROKE.
THE PHYSICIAN RETRACTED THE PROTECTIVE SHEATH ON THE STENT DELIVERY SYSTEM PRIOR TO REACHING THE TARGET LESION SITE IN THE PT'S LEFT ANTERIOR DESCENDING ARTERY AND THE STENT SUBSEQUENTLY EMBOLIZED IN THE PT'S VESSEL. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE EMBOLIZED STENT AND THE PT WAS SENT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THIS WAS REPORTED TO THE MFR EVEN THOUGH IT WAS DETERMINED THE EQUIPMENT DID NOT MALFUNCTION AFTER EQUIPMENT MEMORY WAS REVIEWED.
THE DEVICE WAS PLACED ON 8/16/96. TUBE PLACEMENT WAS VERIFIED BY X-RAY. THE PT HAD A LOW GRADE TEMPERATURE OVER THE FOLLOWING WEEKEND. CAREGIVERS REPORTED DIFFICULTIES FEEDING THROUGH THE DEVICE AND PRESENCE OF BLOOD IN THE EXTENSION TUBE. STAFF TRIED TO REMOVE THE DEVICE. DARK RED DRAINAGE WAS NOTED. THE PT WAS TAKEN TO THE EMERGENCY ROOM. THE PHYSICIAN STATED THE DEVICE WAS PATENT. GRANULATION TISSUE WAS NOTED IN 8/21 AND 8/22. SKIN INFLAMMATION WAS NOTED. ANTIBIOTICS WERE PRESCRIBED.
EVAL SUMMARY: SAMPLE WAS VISUALLY INSPECTED W/NO SIGNS OF ANY DEFECTS FOUND. TESTING WAS PERFORMED ON A PUMP SPIKE SET AND PRODUCT IN A BAG. A 4-PORT CONNECTOR WAS ALSO USED TO CONNECT THE SAMPLE W/ THE REST OF THE SET UP. PUMP WAS SET AT 300 ML/HR FOR ONE HOUR, AFTER THE ONE HOUR PRODUCT DELIVERED AS IT SHOULD. NO DEFECTS WERE FOUND. NO VISUAL OR FUNCTIONAL DEFECT NOTED.
THE INCIDENT OCCURRED DURING A PROCEDURE WHILE CAUTERIZING THE GRAFT. THE GRAFT FLAMED AND SMOKED AND WAS DAMAGED DUE TO CATCHING ON FIRE. THE BURNED END OF THE GRAFT HAD TO BE CUT OFF.
THERE WAS A CORNEAL BURN IN LESS THAN ONE MINUTE OF PHACO TIME. USED SUTURES TO CLOSE AND THE UNIT WAS CHANGED OUT.
H-11: PARTIAL INFO IN SECTION F PROVIDED BY INITIAL REPORT. NO ADD'L INFO HAS BEEN RECEIVED TO DATE.
A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE PT'S TARGET LESION SITE IN A CORONARY ARTERY. UPON THE INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON WOULD NOT INFLATE AT 7 ATMOSPHERES. THE PHYSICIAN INCREASED THE PRESSURE TO 8, THEN 13 ATMOSPHERES TO ACHIEVE BALLOON INFLATION. THE PHYSICIAN STATED THAT THE DELIVERY BALLOON WOULD NOT DEFLATE AND FELT THAT THE BALLOON HAD BURST. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT AND AN ADD'L BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT AT THE TARGET LESION SITE. INTRAVASCULAR ULTRASOUND CONFIRMED OPTIMAL EXPANSION  OF THE STENT. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE RESULTS OF THE PRODUCT EVALUATION REVEALED THAT THE BALLOON INFLATION DIFFICULTY WAS DUE TO THE OVER-TIGHTENING OF THE TUOHY-BORST VALVE WHICH CAUSED NARROWING OF THE BALLOON TUBING. THE PRODUCT EVALUATION REVEALED THAT THE DELIVERY BALLOON WAS INTACT WITH NO LEAKS NOTED DURING FUNCTIONAL TESTING OF THE DEVICE. THE RECOMMENDED MAXIMUM INFLATION PRESSURE OF THE PS1535 IS 7 ATMOSPHERES.
D6: MD REPORTED (1) 0612 BUT RETURNED (2) 0612. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENTS THEMSELVES. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORIES OF THE SUBJECT PRODUCTS COULD NOT BE COMPLETED SINCE THE LOT NUMBERS WERE UNAVAILABLE FROM THE MD'S OFFICE.
THE INCIDENT OCCURRED DURING AN ARTHORSCOPY PROCEDURE WHEN THE PHYSICIAN OBSERVED SWELLING OF THE KNEE AND THIGH ADJACENT TO THE FLUID IN-FLOW SITES. IT WAS DETERMINED THE PUMP WAS DELIVERING PRESSURE GREATER THAN SET GAUGE READING. EQUIPMENT DID NOT ALARM.
FOLLOWING PTCA, THE PHYSICIAN EXPERIENCED DIFFICULTY IN ADVANCING A CORONARY STENT WITH DELIVERY SYSTEM THROUGH TORTUOUS ANATOMY TO THE TARGET LESION SITE IN THE PT'S PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN SLIGHTLY RETRACTED THE PROTECTIVE SHEATH TO CROSS THE LESION SITE AND FULLY DEPLOYED THE STENT. UPON WITHDRAWAL OF THE DELIVERY SYSTEM, A SPIRAL DISSECTION WAS NOTED DISTAL TO THE STENT SITE. THE PHYSICIAN WAS UNCERTAIN AS TO THE CAUSE OF THE DISSECTION AND THE DECISION WAS MADE TO SEND THE PT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO HE EVENT.
PRODUCT LABELING CONTRAINDICATES THE USE OF THIS DEVICE IN TORTUOUS ANATOMY.
THE INCIDENT OCCURRED DURING A LASER PROCEDURE. THE STAFF STATED "THE LASER FIBER WOULD NOT FIRE."
DURING THE PROCEDURE POOR SUCTION CAUSED CAPSULE RUPTURE AND POSSIBLE CORNEAL BURN ON ONE PT.
H11: PARTIAL INFO IN SECTION F PROVIDED BY CUSTOMER'S INITIAL REPORT. NO ADDITIONAL INFO RECEIVED TO DATE. F-10: 1388 - LABELED; 1422 -NA. CODES PROVIDED BY MFR. B-4: 8/1/96.
THIS IS THE SAME PT/EVENT AS MFR# 2219689-1996-00066. AS RECEIVED, THE TIBIAL INSERT EXHIBITS MODERATE WEAR ON BOTH CONDYLES WITH A PREFERENCE TO THE LATERAL-POSTERIOR QUADRANT. THE WEAR PATTERN SUGGESTS AN INTERNAL MAL ROTATION AND/OR A PT ABNORMAL GAIT. THE PATELLAR COMPONENT IS IN GOOD CONDITION SHOWING ONLY MINOR SURFACE SCRATCHES AND A FEW VERY SMALL PITS. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PATELLAR COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE LOT CODE FOR THE TIBIAL COMPONENT HAS NOT BEEN SUPPLIED AND IS NOT VISIBLE ON THE PART SO THAT A REVIEW OF ITS DEVICE HISTORY RECORD IS NOT POSSIBLE. THE INFO PROVIDED AND THE EXAMINATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALIGNMENT OR PT GAIT.
BOVIE SETTING SET AT 60 - 60. TURNED DOWN TO 50 - 50, FOUND LITERATURE STATING TO SET AT 20 - 35, FINISHED CASE AT 20 - 35.
FOUR YRS POST-RESTORATION A SURGICAL INTERVENTION WAS CONDUCTED AT IMPLANT SITE #15 BONE CONTOURING WAS DONE AND ANTIBIOTICS ADMINISTERED AFTERWARD. EIGHT MM OF BONE LOSS WAS RECORDED AT THE TIME OF THIS EVENT. PT IS SAME PT AS PRIOR MDR REPORTS M408204, M408206, M408294, AND 493270.
METHOD (86): PART WILL NOT BE RETURNED - STILL IN FUNCTION. REQUESTED INFO AS FOLLOWS: A2 F10 F12 F6 F8 F9 H8.
THE PT BECAME ISCHEMIC AS THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO CROSS THE TARGET LESION SITE IN A CALCIFIED AND TORTUOUS PROXIMAL CIRCUMFLEX ARTERY WITH A CORONARY STENT WITH DELIVERY SYSTEM. THE LESION WAS NOT REDILATED. THE CCL TECHNICIAN INADVERTENTLY RETRACTED THE PROTECTIVE SHEATH AND AN ADD'L ATTEMPT TO CROSS THE LESION WAS UNSUCCESSFUL. DURING WITHDRAWAL OF THE DELIVERY SYSTEM, THE STENT EMBOLIZED IN THE LEFT MAIN CORONARY ARTERY. AN ADD'L CATHETER WAS USED TO ENGAGE THE STENT TO WITHDRAW IT OUT OF THE LEFT MAIN AND INTO THE PT'S AORTA. AN ADD'L GUIDEWIRE WAS USED TO SECURE THE STENT FOR WITHDRAWAL TO THE VASCULAR ACCESS SITE WHERE IT WAS SURGICALLY REMOVED. THE TARGET LESION SITE WAS TREATED WITH BALLOON ANGIOPLASTY A FEW DAYS LATER. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THIS DEVICE IS NOT INDICATED FOR USE IN TORTUOUS ANATOMY. PRODUCT LABELING RECOMMENDS PREDILATING THE LESION PRIOR TO ATTEMPTED STENT PLACEMENT.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. POST EXPLANT THE PHYSICIAN NOTED THE LEAD TO BE FRACTURED WITH PROTRUSION.
THIS ENTIRE FORM COMPLETED BY MANUFACTURER. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE WAS FRACTURED ~5MM AND ~15MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES ~73MM AND HAS MIGRATED DOWN LEAD BODY ~120MM PROXIMAL OF WELD SITE. THE OUTER ANODE COIL WIRE WAS ALSO RECEIVED FRACTURED ~20.5CM AND ~24CM DISTAL OF PROXIMAL TERMINAL PIN. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER FRACTURES ALONG BOTH OUTER ANODE COIL WIRE FRACTURES.
A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY. THE PHYSICIAN WAS UNABLE TO RETRACT THE PROTECTIVE SHEATH AND DURING HIS ATTEMPTS, BELIEVED A DISSECTION OCCURRED. THE STENT WITH DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION AND THE PHYSICIAN'S ATTEMPT TO PLACE ANOTHER MFR'S STENT WAS UNSUCCESSFUL. A PERFUSION BALLOON USED IN THE ATTEMPT TO REPAIR THE DISSECTION WAS ALSO UNSUCCESSFUL. THE DECISION WAS MADE TO SEND THE PT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
DURING THE ADVANCEMENT ATTEMPT OF A CORONARY STENT WITH DELIVERY SYSTEM TOWARD THE TARGET LESION SITE IN THE PT'S CORONARY ARTERY, THE STENT EMBOLIZED. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION AND AN ADD'L BALLOON CATHETER WAS USED TO SUCCESSFULLY RETRIEVE THE EMBOLIZED STENT. A SECOND CORONARY STENT WITH DELIVERY SYSTEM WAS USED TO SUCCESSFULLY PLACE A STENT AT THE PT'S TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE RESULTS OF THE PRODUCT EVALUATION DETECTED A LEAK IN THE KYNAR COATING OF THE INNER MEMBER. THIS DEFECT HAS NO RELATIONSHIP TO THE REPORTED COMPLAINT.
THREE YRS POST RESTORATION A SURGICAL INTERVENTION WAS CONDUCTED AT IMPLANT SITE #23 (11 U.S.) IN AN ATTEMPT TO STOP PROGRESSIVE BONE LOSS WHICH MEASURED 10 MM. AT THE TIME OF THIS EVENT DFDS GRAFT WAS PLACED AND THE HA COATING REMOVED. INFECTION WAS PRESENT. THIS INFECTION AND BONE LOSS LED TO IMPLANT REMOVAL ON 5/15/96. PT IS SAME PT AS PRIOR MDR REPORTS. M347291, M399375, AND M757469.
METHOD (86): PART NOT RETURNED. REQUESTED INFO AS FOLLOWS: F10 F12 F6 F8 F8 H8.
THIS ENTIRE FORM COMPLETED BY MANUFACTURER.
THE PT WAS EXPERIENCING PAIN. X-RAYS INDICATED NARROWING OF THE JOINT SPACE. REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT. THE FEMORAL COMPONENT AND TIBIAL BASEPLATE WERE WELL SECURED AND REMAINED IMPLANTED.
A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY. UPON THE INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON BURST LEAVING THE STENT UNEXPANDED IN THE VESSEL. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION AND A MECHANICAL SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE STENT. A SECOND CORONARY STENT WITH DELIVERY SYSTEM WAS USED TO SUCCESSFULLY PLACE A STENT AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE RESULTS OF THE PRODUCT EVALUATION REVEALED A PINHOLE LEAK IN THE DELIVERY BALLOON AND A LEAK IN THE KYNAR COATING OF THE INNER MEMBER. THE STENT WAS NOT RETURNED FOR EVALUATION.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE PATELLA AND TIBIAL INSERT.
INFO HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, SUPPLEMENTAL REPORT WIL BE SUBMITTED.
AT AN UNDETERMINED PERIOD OF TIME FOLLOWING SUCCESSFUL STENT PLACEMENT, THE PT DEVELOPED STENT THOMBOSIS.
MULTIPLE ATTEMPTS TO CONTACT PHYSICIAN BY TELEPHONE TO OBTAIN CASE DETAILS HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL ATTEMPTS TO CONTACT THE PHYSICIAN WILL BE MADE.
THIS ENTIRE FORM COMPLETED BY MANUFACTURER. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED ~29MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION J STIFFENER WIRE MEASURES ~49MM AND HAS MIGRATED DOWN LEAD BODY ~35MM PROXIMAL OF WELD SITE. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE OUTER POLYURETHANE INSULATION HAS AN ABRADED HOLE ~32MM PROXIMAL OF WELD SITE. IT APPEARS THAT ~10MM OF THE J STIFFENER WIRE WAS NOT RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO ~78MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE LEAD WAS SNIPPED OR CUT ~37CM PROXIMAL OF FIXATION HELIX HOUSING ELECTRODE TIP, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURE.
THE PROTECTIVE SHEATH ON A CORONARY STENT WITH DELIVERY SYSTEM WAS RETRACTED PRIOR TO REACHING THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY WHICH RESULTED IN STENT EMBOLIZATION. THE PHYSICIAN WAS UNCERTAIN AS TO THE LOCATIONS OF THE EMBOLIZED STENT AND THE DECISION WAS MADE TO SEND THE PT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. THERE WERE NO ADD'L CLINICAL SEQUEALE REPORTED RELATIVE TO THE EVENT.
SECTION F: PARTIAL INFO PROVIDED BY CUSTOMER'S INITIAL REPORT AND FOLLOW-UP #1. NO ADD'L INFO HAS BEEN RECEIVED TO DATE.
FOLLOW UP INDICATED NO PERMANENT INJURY OCCURRED.
THE PT EXPERIENCED PAIN AND SWELLING. REVISION SURGERY REVEALED POLYETHYLENE DELAMINATION OF THE TIBIAL INSERT ON THE MEDIAL SIDE AND DECOMPOSITION OF LATERAL SIDE. THE TIBIAL BASEPLATE WAS ALSO REMOVED AT THIS TIME.
A CORONARY STENT WITH DELIVERY SYSTEM WAS ADVANCED TOWARD THE TARGET LESION SITE IN THE PT'S PROXIMAL LEFT ANTERIOR DESCENDING ARTERY NEAR THE OSTIUM OF THE LEFT MAIN CORONARY ARTERY. THE PHYSICIAN WAS UNABLE TO CROSS THE TARGET LESION SITE DUE TO CALCIFICATION PRESENT IN THE VESSEL. THE PROTECTIVE SHEATH WAS RETRACTED AND AN ATTEMPT TO CROSS THE LESION SITE WAS UNSUCCESSFUL. THE PHYSICIAN PUSHED THE DEVICE FORWARD WHICH RESULTED IN THE EMBOLIZATION OF THE STENT IN THE VESSEL. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION. A SNARE WAS USED TO RETRIEVE THE EMBOLIZED STENT. THE TARGET LESION SITE WAS TREATED WITH BALLOON ANGIOPLASTY. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
ONLY THE STENT, NOT THE DELIVERY SYSTEM, WAS RETURNED FOR EVALUATION. PRODUCT LABELING STATES THAT THE SHEATH SHOULD NOT BE WITHDRAWN UNTIL THE OPERATOR IS READY TO EXPAND THE STENT. FAILURE TO DO SO MAY CAUSE PREMATURE DISLODGEMENT OF THE STENT FROM THE DELIVERY BALLOON. PRODUCT LABELING RECOMMENDS THAT IF ANY RESISTANCE IS ENCOUNTERED WHILE ADVANCING THE STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE, THE ASSEMBLY MAY BE WITHDRAWN THROUGH THE INTRODUCER SHEATH AND GUIDE CATHETER AND THE PROCEDURE ABORTED.
REPORTER STATED HE ENCOUNTERED RESIDUAL VACUUM. A RETINAL HOLE OCCURRED, REQUIRING A SCLERAL BUCKLE.
PT INFO HAS BEEN REQUESTED, BUT NOT REC'D TO DATE. THE MFR'S INTERNAL REF # 8-8811-96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21 CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
DURING AN ATTEMPT TO ADVANCE AN ENDOVASCULAR STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S ILIAC ARTERY, THE DELIVERY SYSTEM SNAGGED ON PLAQUE. THE DELIVERY SYSTEM WAS RETRACTED AND GUIDEWIRE POSITION WAS LOST. AS THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT, THE STENT DISLODGED FROM THE BALLOON CATHETER. THE PHYSICIAN WAS UNABLE TO REGAIN GUIDEWIRE SUPPORT AND THE DECISION WAS MADE TO SEND THE PT FOR FEMORAL-FEMORAL BYPASS SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THIS STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY.
THE DEVICE WAS IMPLANTED ON 8/12/96 FOR INTRATHECAL INFUSION OF MORPHINE FOR TREATMENT OF PAIN. ON 8/20/96, THE PHYSICIAN CONTACTED A MFR NURSE AND REPORTED THAT AT THE TIME OF IMPLANT, THE DEVICE WAS REFILLED WITH 24CC PRESERVATIVE FREE MORPHINE SULFATE (PFMS)-(0.2 MG/DAY). THE DEVICE WAS REFILLED ON 8/20/96; HOWEVER, ONLY 4CC HAD INFUSED. (RESIDUAL VOLUME 20CC). THE PHYSICIAN STATED THAT HE ATTEMPTED TO FLUSH THE DEVICE SIDEPORT, BUT WAS UNABLE TO ACCESS IT. THE PHYSICIAN ALSO STATED THAT HE WAS IN ER AT THE TIME AND THE CONDITIONS WERE NOT IDEAL TO TRY MORE THAN ONCE. THE DEVICE WAS THEN REFILLED WITH 50CC PFMS 0.4MG/DAY. THE PT HAS REPORTED A DEFINITE IMPROVEMENT. THE PHYSICIAN STATED THAT HE WILL MONITOR THE PT OVER THE NEXT WEEK AND IF IMPROVEMENT CONTINUES, HE WILL REFILL THE DEVICE AT THE EXPECTED INTERVAL; IF NOT, HE WILL BRING THE PT BACK AND DO A SIDEPORT STUDY UNDER FLUOROSCOPY TO CHECK PATENCY.
ON 10/1/96, THE PHYSICIAN REPORTED THAT THE PATIENT IS DOING WELL AND "EVERYTHING APPEARS TO BE FINE." THE DEVICE PORT HAS BEEN ACCESSED AND WAS FOUND TO BE PATENT AND THE DEVICE APPEARS TO BE FUNCTIONING AS INTENDED. THE PHYSICIAN ALSO STATED THAT THE DEVICE WILL NOT BE ACCESSED AGAIN FOR APPROXIMATELY ONE MONTH; HOWEVER, NO FURTHER DIFFICULTIES ARE BEING EXPERIENCED AT THIS TIME. THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN. A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS PART NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, AND DUE TO UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS REPORT.
FOLLOW-UP REVEALED RN PUT HOLDER WITH CONTAMINATED NEEDLE IN HER POCKET AFTER PHLEBOTOMY PROCEDURE WHEN ATTEMPT TO SHIELD NEEDLE DID NOT WORK. NEEDLESTICK OCCURED WHILE NEEDLE WAS IN HER POCKET. LOT NUMBER WAS UNOBTAINABLE THROUGH HOSP. SECTION F10-DEVICE CODE ADDED 1416.
PROSTHETIC VALVE ENDOCARDITIS, LARGE VEGETATIONS ON TWO LEAFLETS AND STROKE WITH DEBRIDEMENT OF ROOT ABSCESS. STAPHYLOCCOCUS EPICARDIAL.
FOUR YRS POST-RESTORATION THE IMPLANTS AT SITES 7 AND 10 WERE REBURIED. PT IS SAME PT AS PRIOR MDR REPORTS #M351845, M362408, M370373, M475523. M522878, M607081, M567665 AND 725702.
THE DEVICE WAS APPLIED DURING A PNEUMOTHORAX PROCEDURE. REPORTEDLY, THE STAPLE LINE WAS INCOMPLETE. THE SURGEON RESECTED THE TISSUE AND COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY. DATE DEVICE EXPIRES: 5/31/2001.
10/4/96-SUPPLEMENTAL REPORT SUBMITTED WITH ADD'L INFO ENTERED IN SECTIONS D-7, D-8 AND D-9. EVALUATION INDICATED AND CODES ENTERED IN H-3 AND H-6.
F9: 6 YRS. F10: PT CODE: 1715. DEVICE CODE: 2204. F12: HOSP. F13: NO. F14: RETER TO D3.
THE PHYSICIAN DETERMINED THAT THE VENTRICULAR PACING LEAD SHOWED NO OUTPUT OR CAPTURE PRIOR TO THE PROCEDURE AND A LEAD RESISTANCE OF 2500 OHMS WAS NOTED AT THE TIME OF EXPLANT. THE PACEMAKER WAS EXPLANTED ELECTIVELY AND REPLACED BY A NEW PACEMAKER.
LEFT CAROTID ENDARDERECTOMY PT (SURGERY DATE: 9/5/96) WAS DISCHARGED TO HOME ON 9/7/96. PT RETURNED TO THE ER ON 9/7/96 WITH RUPTURE AND HEMORRHAGE OF LEFT CAROTID ARTERY (SURGICAL SITE). UPON RETURN TO SURGERY AND DE-CLOT-TING OF THE SURGICAL SITE (ARTERY), A SUTURE WAS OBSERVED BY THE SURGEON TO HAVE SPLIT APART. DATE DEVICE EXPIRES: 5/2001.
FOUR YRS POST-RESTORATION THE IMPLANT AT SITE 12 WAS REBURIED. PT IS SAME PT AS PRIOR MDR REPORTS #M351845, M362408, M370373, M475523, M522878, M667684, M667525, AND 725702.
THE PACEMAKER LEAD WAS IMPLANTED WITH ACCEPTABLE VALUES (0.9V CAPTURE THRESHOLD). TWO DAYS POST IMPANT THE LEAD INDICATES A RISE IN THE CAPTURE THRESHOLD TO 2.9V. SIX DAYS POST IMPLANT THE CAPTURE THRESHOLD OF THIS LEAD INDICATED >8.4V. THE PHYSICIAN ELECTED TO EXPLANT THIS LEAD AND IMPLANT AN ACTIVE FIXATION LEAD.
THE DC RESISTANCE BETWEEN TIP AND PIN IS WITHIN SPECIFICATION. THE COMPLEX IMPEDANCE WAS MEASURED WITH RESPECT TO FREQUENCY OF THE TEST SIGNAL AND WAS COMPLETELY WITHIN SPECIFICATION. THE VISUAL INSPECTION OF THE LEAD INSULATION SHOWED A DISTANCE OF 270 MM FROM THE PIN TO CUTS IN THE INSULATION, WHICH ARE FILLED WITH COAGULATED BLOOD RESIDUALS. AT A DISTANCE OF 300 MM FROM THE PIN, THERE ARE CUTS IN THE INSULATION WHICH DO NOT COMPLETELY CUT THROUGH THE INSULATION.
ALLEGED DEFLATION. FOLLOW-UP FINDINGS: AS PER OP REPORT RECEIVED 9/9/96 PATIENT ALSO HAD INFECTION OF UNK ETIOLOGY AS WELL AS DEFLATION.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO'S DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AND ACCURATE REFLETION OF CO'S EVALUATION OF THE DEVICE.
THE APPLIER WAS USED DURING A LAPAROSCOPIC CHOLECYSTECOMY. THE CLIPS WERE FALLING OUT. THE CLIPS WERE RETRIEVED LAPAROSCOPICALLY. A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
F1-SHOULD NOT HAVE BEEN CHECKED ON INITIAL MEDWATCH. NO MEDWATCH WAS RECEIVED BY USER FACILITY. G3: HEALTH PROFESSIONAL WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH.
THE VENTRICULAR LEAD INDICATED A RESISTANCE OF >2000 OHM. THE LEAD WAS TESTED USING SURGICAL INTERVENTION. THE LEAD VALUES INDICATED ACCEPTABLE VALUES. THE PHYSICIAN DETERMINED THAT THE PACEMAKER CONNECTOR WAS THE CAUSE OF THE INTERMITTENT NON-CAPTURE. THE PACEMAKER WAS EXPLANTED. THE VENTRICULAR LEAD WAS REPOSITIONED AND RE-USED.
CO HAS ANALYZED THIS PACEMAKER WITH THE FOLLOWING RESULTS: IT WAS SUBJECTED TO A COMPLETE FINAL ACCEPTANCE TEST AND PROVED TO BE WITHIN ALL ELECTRICAL SPECIFICATIONS, INCLUDING THE ANALUGY DATA TELEMETRY. IT WAS INSPECTED VISUALLY WITH THE RESPECT TO THE DIMENSIONS OF THE TERMINALS AND THE HEADER INCLUDING THE BORE. DIMATERE FOR THE CONNECTOR PINS AND THE FUNCTIONALITY OF THE SET SCREW MECHANISM. THERE WERE NO DEVIATIONS FROM THE SPECIFICATIONS. THIS UNIT IS NOT DEFECITIVE.
LEAKAGE FROM TWO SITES OF IMPLANTED PORT CATHETER RESULTING IN APPARENT EXTRAVASATION OF CHEMOTHERAPY AGENT INTO RIGHT SHOULDER AREA. SEQUENCE OF EVENTS: ON 8/16/96 PORT WAS IMPLANTED. ADRIAMYCIN INFUSION INITIATED 8/17/96. ON 8/21/96 INDICATIONS OF APPARENT EXTRAVASATION WERE EVIDENCED BY ERYTHEMA AND NECROSIS OF THE OVERLYING SKIN. CHEMOTHERAPY WAS SUBSEQUENTLY DISCONTINUED AND AFFECTED AREA IMPROVED. RADIOLOGY CONTRAST STUDY COMPLETED ON 9/9/96 INDICATED LEAKAGE AT TWO SITES. SURGICAL PROCEDURE TO REMOVE THE PORT CATHETER WAS COMPLETED 9/10/96.
TWO AND 1/2 YRS POST-RESTROATION, A SURGICAL INTERVENTION WAS CONDUCTED AT IMPLANT SITES 30 AND 31. PROCEDURES INCLUDED IRRIGATION WITH SODIUM CHLORIDE, PLACEMENT OF TETRACYCLINE PASTE AND PLACEMENT OF DFDB AND BIOMEND MEMBRANE. PT IS SAME PT AS PRIOR MDR REPORTS #M575086 AND M575087.
METHOD(86): PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM OFFICE. REF #M757086, M575087.
THE APPLIER WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE REP WAS GIVEN THE BOX WITH "CLIPS FALLING OFF" AND "MALFUNCTIONING" WRITTEN ON IT. NO OTHER INFO IS AVAILABLE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,710-INFO NOT PROVIDED BY USER FACILITY F1: SHOULD NOT HAVE BEEN CHECKED ON INITIAL MEDWATCH. NO MEDWATCH WAS RECEIVED BY USER FACILITY. D5;G4; H4-INFO NOT AVAILABLE G3; USER FACILITY WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH. H6-CODE 400 (OTHER): YIELDED JAWS CONCLUSION BASED UPON INQUIRY INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF JAWS ARE CLOSED OVER A HARD OBJECT, JAWS CAN BECOME DAMAGE AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
THE IMPLANTED PACEMAKER INDICATED "CROSSTALK" IN THE PRESENCE OF AN IMPLANTED NEUROSTIMULATOR.
A WARRANTY TEST WAS PERFORMED AND THE DEVICE HAS BEEN DETERMINED TO BE FUNCTIONING WITHIN SPECIFICATION.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT. THE FEMORAL COMPONENT AND TIBIAL BASEPLATE WERE ALSO REVISED AT THIS TIME TO COMPATIBLE REVISION COMPONENTS.
INFO HAS BEEN PROVIDED AS REQUESTED. SECTION F1-F14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS TIBIAL INSERT COULD NOT BE EVALUATED FOR THE REPORTED WEAR AS IT HAS NOT BEEN RETURNED TO CO. THE LOT CODE HAS NOT BEEN SUPLLIED SO  THAT A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE. ATEMPTS TO OBTAIN THE DEVICE, CATALOG NUMBER, AND LOT CODE INFORMATION HAVE BEEN UNSUCCESSFUL.
CROWN CAME OFF TISSUE PUNCH USED TO REOPEN GINGIVAL ACCESS TO REPLACE ABUTMENT AND CROWN. PT IS REPORTEDLY FINE.
PT WAS FOUND AT 5:25 AM WITH HEAD THROUGH SIDERAILS, FACE DOWN. HER NECK WAS EITHER ON BOTTOM BAR OR NIGHT GOWN WAS PULLED TIGHT AROUND NECK. THERE WAS A RED MARK ON SIDE OF NECK. PT HAD EXPIRED.
THE APPLIER WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS WERE SPLITTING OUT OF THE APPLIER AFTER FIRING. AFTER 7-8 CLIPS SPIT OUT THE SURGEON ASKED FOR ANOTHER CO'S ENDO CLIP TO COMLPETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. RPO.
A1,2,3,4;B6,7;D10: CONTACTED FACILITY, INFORMATION NOT PROVIDED. D5,6;H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIPS WERE NOT HOLDING.  ANOTHER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED AND FED THE CLIPS AS DESIGNED. THE CLIP FORM WAS WITHIN DESIGN SPECIFICATION. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. PLEASE SEND USED CLIPS BACK WITH INSTRUMENT WHEN POSSIBLE. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED PROPERLY AND THAT THE CLIP FORM IS WITHIN DESIGN SPECIFICATION.
ATTEMPTING TO STENT MID RCA, STENT IN PLACE WHEN IT COLLAPSED INTO THE AORTA & HAD TO BE RETRIEVED. PROCEDURE STOPPED, NEW STENT SUCCESSFULLY PLACED 3 DAYS LATER.
A DIABETIC REPORTS A HYPOGLYCEMIC EVENT INVOLVING A FALL TO THE FLOOR AND UNCONSCIOUSNESS FOR AN UNKNOWN PERIOD. DUE TO THE EVENT, THE DIABETIC SUFFERED A "BUMP" TO THE HEAD. NO TREATMENT WAS GIVEN. THE DIABETIC REGAINED CONSCIOUSNESS WITHOUT ASSISTANCE. THE DEVICE HAD REPORTED A FASTING BLOOD GLUCOSE VALUE OF 285 MG/DL IN THE EARLY MORNING. THE DIABETIC FELT DIZZY AND "PASSED OUT".
PRODUCT HAS A DEFECTIVE INTRODUCER. PHYSICIAN WAS PULLING AIR INTO THE SYRINGE WHEN TRYING TO FLUSH THE INTRODUCER. THERE WERE BENDS AND PUNCTURES IN THE INTRODUCER.
AN ABUTMENT SCREW HAS FRACTURED INSIDE AN IMPLANT. THE FRAGMENT WAS RETRIEVED SUCCESSFULLY. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
WHEN THE DILATION CATHETER WAS PLACED IN THE CORONARY ARTERY, THE CVT COULD NOT GET THE STATIC OUT OF THE IMAGE. WHEN THE PHYSICIAN REPLACED IT WITH A NEW CATHETER, IT WORKED FINE AND THE PROCEDURE WAS COMPLETED.
TWO IMPLANTS HAVE FRACTURED. PT INJURY HAS NOT BEEN REPORTED.
DENTAL ASST REPORTED THAT A PT PRESENTED WITH PAIN IN AREA OF #22, WAS PART OF OVERDENTURE WITH ZEST ATTACHMENT. INFECTION WAS PRESENT, PT WAS LAST SEEN ONE YR PRIOR. NO PROBLEMS NOTED AT THE TIME. PT IS SAME PT AS PRIOR MDR REPORT #M519785.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMETNS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DOCTOR'S OFFICE.
CLARIFICATION OF DETAILS FROM STENTING PHYSICIAN: THE PHYSICIAN EXPERIENCED DIFFICULTY IN ADVANCING A CORONARY STENT WITH DELIVERY SYSTEM THROUGH TORTUOUS ANATOMY TOWARD THE TARGET LESION SITE IN THE PT'S MID RIGHT CORONARY ARTERY. THE GUIDE CATHETER, GUIDEWIRE AND DELIVERY SYSTEM PROLAPSE OUT OT THE VESSEL AND THE STENT EMBOLIZED AND REMAINED ON THE GUIDEWIRE. A SNARE WAS USED TO SUCCESSFULY RETRIEVE THE EMBOLIZED STENT. NO FURTHER ACTIONS WERE PERFORMED. ANOTHER STENT WAS SUCCEWSSFULLY PLACED AT THE TARGET LESION SITE THREE DAYS LATER. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. PT DOCES: 2199. DEVICE CODES: 1467, 1179. THE DEVICE IS NOT INDICATED FOR USE IN TORTOUS ANATOMY.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE APPLIER WOULD LOCK DOWN ON TISSUE AND THE JAWS WOULD NOT OPEN. THE SURGEON "HAD TO TEAR AWAY" THE INSTRUMENT TO REMOVE IT FROM DUCTAL STRUCTURES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
ON 8/27/96 1630 CONTACT PERSON STATED SHE HAD NO INFO TO PROVIDE, BUT WOULD ASK THE SURGEON'S PRIVATE SCRUB PERSON TO CALL BACK WITH ANY INFO HE MAY HAVE RELATED TO THIS EVENT. ON 8/28/96 1445 HE CALLED BACK AND REPORTED THE INSTRUMENT WOULD NOT RELEASE. HE STATED THERE WAS NO DAMAGE TO THE DUCT WHEN IT FINALLY WAS REMOVED AND THE CASE WAS COMPLETED WITH ANOTHER INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
WHILE SHEATHING NEEDLE, USER ACCIDENTALLY STUCK SELF IN THUMB.
DR REPORTED THAT HE WAS REMOVING CROWN WHEN COMPLETE IMPLANT CAME OUT.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS COMPLETED AND FOUND ACCEPTABLE PER RELEASE CRITERIA.
THE DEVICE WAS USED DURING A LUNG VOLUME REDUCTION WITH BOVINE PERICARDIUM. THE DEVICE WAS FIRED ONE TIME WITH BOVINE PERICARDIUM AND THE HANDLE BECAME NON-FUNCTIONAL. THE DEVICE WOULD NOT FIRE. THERE WAS NO CONSEQUENCE TO THE PT. RPO 8/27/96 REP REPORTS THE CASE WAS COMPLETED WITH A SECOND ELC60 AND EZ45B.
9/6/96 1235, MESSAGE AND 800# LEFT ON ANSWERING MACHINE FOR RISK MANAGEMENT. 9/17/96 MED WATCH RECEIVED. 9/9/96 DR. WAS PERFORMING AN APPENDECTOMY. HE WAS USING A WHITE CARTRIDGE WITH THE EZ PRODUCT ACROSS THE BASE OF THE APPENDIX. WHEN FIRING THE INSTRUMENT IT APPEARED TO FIRE FINE, BUT THERE WAS AN UNUSUAL SOUND. HE WAS UNABLE TO OPEN THE INSTRUMENT. WITH SOME DIFFICULTY HE WAS ABLE TO GET SOME RELEASE, HOWEVER, THE JAWS DID NOT OPEN SATISFACTORLY TO RELIEVE FROM THE TISSUE. THE PATIENT WAS CONVERTED TO A MINI-LAPAROTOMY AND THE INSTRUMENT WAS PRIED OPEN WITH A HEMOSTAT AND THEN WAS REMOVED. THE INSTRUMENT IS BEING RETURNED AND PHOTOS WERE TAKEN. THERE IS NO VIDEO. A1,2,3,4:INFO NOT PROVIDED DURING INTITIAL CONTACT. FOLLOW UP LETTER SENT TO FACILITY REQUESTING ADD'L INFO. F1:SHOULD NOT HAVE BEEN CHECKED. NO MEDWATCH WAS RECEIVED FROM USER FACILITY.
8/5/96 NEEDLESTICK FIRST REPORTED AS ACCIDENTAL. AND WOULD HAVE NOT MET CRITERIA FOR MDR REPORTABILITY UNDER NEEDLESTICK GUIDANCE DOCUMENT -EL9960003. FOLLOW-UP ON 9/13/96 REVEALED HOSP EMPLOYEE ALLEGES SHEATHING MECHANISM MAY HAVE BEEN CONTRIBUTORY. MLT STUCK HERSELF WITH NEEDLE WHILE SHEATHING NEEDLE. TETANUS SHOT AND BASELINE TESTING ADMINISTERED. SECTION F10 - DEVICE CODE ADDED 1416. INFO RECEIVED ON MEDWATCH FORM FROM USER FACILITY WITHOUT USER FACILITY REPORT NUMBER.
PT SITTING ON STRETCHER TO VOID. PT FELL TO FLOOR AND HIT OBJECTS. SUSTAINED FRACTURED ELBOW WITH RESULTANT PAIN. PT HAD TO BE HOSPITALIZED. STRETCHER WAS IN LOCKED POSITION BUT WAS STILL ABLE TO ROLL WITH PUSHING.
THE DEVICE WAS USED DURING A LAPAROSCOPIC SALPINGO-OOPHERECTOMY. THE DEVICE WAS CLOSED ACROSS THE FALLOPIAN TUBE AND FIRED. THE DEVICE DID NOT CUT NOR STAPLE. NO BUTTRESSING MATERIAL WAS USED. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
CONTACTED SURGEON AND RISK MANAGER. INFO NOT AVAILABLE. DEVICE NOT RECEIVED YET. INFO NOT KNOWN.ON 8/27/96 1545 SPOKE WITH SURGEON WHO REPORTED HE PLACED THE DEVICE ACROSS THE RIGHT FALLOPIAN TUBE AND CLOSED THE DEVICE WITHOUT DIFFICULTY. THE SURGEON SAID HE EXPERIENCED NO DIFFICULTY WHEN HE FIRED THE DEVICE. THE SURGEON STATED WHEN HE OPENED THE DEVICE HE NOTICED IT HAD NOT STAPLED OR CUT. THE SURGEON REPORTED THE TISSUE AT THIS SITE WAS CRUSHED, BUT WAS NOT BLEEDING. THE SURGEON SAID HE HAD ANOTHER DEVICE OPENED WHICH HE FIRED ACROSS THE SAME SITE WITHOUT DIFFICULTY. THE SURGEON REPORTED THERE WAS NO CONSEQUENCE TO THE PT.
PT ADMITTED IN CRITICAL CONDITION FROM ER WITH 100% OCCLUDED LAD DUE TO THROMBOSIS, WHICH DID NOT RESPOND TO CLOT DISSOLVING TPA TREATMENT.  ANGIOPLASTY CATHETER WAS PLACED IN TARGET LESION IN AN ATTEMPT TO BREAK UP CLOT, AND INFLATED WITH 100% CONTRAST MEDIA. CATH LAB REPORTED A SLOW DEFLATION TIME OF 10-15 SECONDS AND A 35CC SYRINGE WAS USED TO FACILITATE DEFLATION. UPON WITHDRAWAL OF THE CATHETER, PHYSICIAN STATED THAT PART OF THE CLOT HAD MOVED INTO THE CIRCUMFLEX WHICH HAD PREVIOUSLY BEEN OPEN, AND BLOCKED THE FLOW, CONTRIBUTING TO THE PT'S DEATH. DR STATED HE DID NOT KNOW CATH LAB DID NOT FOLLOW INSTRUCTIONS AND USED 100% MEDIA, AND THE SLOW DEFLATION TIME CONTRIBUTED TO BUT DID NOT CAUSE THE PT'S DEATH. DR STATED HE DID NOT KNOW CATH LAB DID NOT FOLLOW INSTRUCTIONS AND USED 100% MEDIA AND THE SLOW DEFLATION TIME CONTRIBUTED TO BUT DID NOT CAUSE THE PT'S DEATH.
THE PRODUCT WAS NOT RETURNED TO MIV FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THE CATH LAB REPORTED THE DEFLATION TIME WAS APPROXIMATELY BETWEEN 10-15 SECONDS, AND 100% CONTRAST MEDIA WAS USED TO INFLATE THE BALLOON. THE PRODUCT SPECIFICATION FOR DEFLATION TIME FOR THIS MODE IS 15 SECONDS MAXIMUM WHEN INFLATED WITH DILUTED CONTRAST MEDIA AS STATED PER THE LABELED INSTRUCTIONS FOR USE. THE LABELING SPECIFICS USING 50-60% CONTRAST MEDIA OR A 50/50 MIXTURE 76% CONTRAST AND STERILE SALINE. A WARNING ALSO INDICATES USE ONLY THE RECOMMENDED INFLATION MEDIUM. IN ORDER TO REPEAT THE FAILURE UNDER THE REPORTED OFF LABELED USE, SIX NEW SAMPLES FROM THE SAME LOT WERE TESTED AS FOLLOWS TO REPLICATE THE IMPACT OF CONTRAST MEDIA DILUTION: (A) THREE SAMPLES WERE TESTED WITH 100% RENOCAL-76 CONTRAST MEDIA, AND (B) THREE SAMPLES WERE TESTED USING THE PROPER 50/50% DILUTION OF RENOCAL-76 AND SALINE. THE AVERAGE INFLATION AND DEFLATION TIMES WHEN TESTED WITH 100% SOLUTION WERE 5.6 SECONDS AND 27.7 SECONDS RESPECTIVELY. THE AVERAGE INFLATION AND DEFLATION TIMES WHEN TESTED WITH 50/50% SOLUTION WERE 1.6 SECONDS AND 6.94 SECONDS RESPECTIVELY. SUMMARY OF INVESTIGATION: DURING THE ROOT CAUSE ANALYSIS, WE CONCLUDED THAT THE REPORTED DEFLATION INCIDENT WAS NOT A PRODUCT MALFUNCTION, BUT WERE ABLE TO DUPLICATE THE REPORTED COMPLAINT. THEREFORE, THE REPORTED SLOW DEFLATION TIME WAS RELATED TO NOT FOLLOWING THE INSTRUCTIONS FOR USE BY INFLATING THE BALLOON WITH 100% CONTRAST MEDIA INSTEAD OF A DILUTED SOLUTION. CORRECTIVE ACTION: A LETTER REFERENCING THE PROPER DILUTION OF CONTRAST MEDIA AND THE ABOVE COMPARISON TEST DATA WAS SENT TO THE PHYSICIAN AND STAFF. IN ADDITION, TO PREVENT RECURRENCE OF THIS TYPE, THE SALES REP WILL RETRAIN THE CATH LAB STAFF ON THIS ISSUE. THE PHYSICIAN WAS ALSO ADVISED ON THE NEW MDR REPORTING REGULATIONS FOR USER FACILITIES CONCERNING DEATH AND SERIOUS INJURIES. NO FURTHER CORRECTIVE ACTION REQUIRED AT THIS TIME.
HOSP PERSONNEL ATTENDED TO AN AUTOMOBILE ACCIDENT PT IN A TRIAGE SITUATION. PACING THERAPY WAS ATTEMPTED AND ALLEGEDLY THE UNIT DISPLAYED THE PACING LEADS OFF MESSAGE AND STOPPED PACING. WITHOUT HESITATION, THE OPERATOR IMMEDIATELY USED ANOTHER PACEMAKER AND CONTINUED PACING ATTEMPTS. THE PT DID NOT SURVIVE. THE REPORTER INDICATED THE DEVICE DID NOT LIKELY CONTRIBUTE TO THE DEATH OF THE PT. THIS OPINION WAS BASED UPON THE AVAILABILITY OF ANOTHER PACEMAKER AND THE LACK OF PT VIABILITY.
CO EVALUATED THE UNIT AND FOUND IT TO PERFORM NORMALLY DURING PERFORMANCE AND FUNCTIONAL TESTING. THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. THE FACILITY HAS DECLINED CO'S OFFER TO PROVIDE ADD'L TRAINING.
THE PUMP WAS TESTED BY THE HOSP'S BIOMED AND NO FAULT WAS FOUND. THE PUMP HAS NOT BEEN RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED WHEN THE EVALUATION HAS BEEN COMPLETED. SECTION-A,B,D AND E WHERE FILLED OUT BY THE USER FACILITY PER THE ATTACHED VOLUNTARY MEDWATCH REPORT. NO INFO SUPPLIED IN A-1 OR B-6. CORRECTIONS WERE MADE BY THE MFR IN SECTION D-3 MFR'S ADDRESS, D-6 CAT#, SERIAL#, OTHER #. D-9 DEVICE IS AVAILABLE AND WILL BE RETURNING FOR EVALUATION. MFR'S REPORT DATE 11/1/96, FILE# 10-96-57
PT CAME IN WITH TWO LOOSE IMPLANTS, DID NOT INTERGRATE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.
STENT PREPPED CORRECTLY BY SCRUB ASSISTANT AND PHYSICIAN. STENT WOULD NOT DEPLOY OFF OF BALLOON WHEN ATTEMPTED.
LARGE BREAK IN METAL ARM OF HANGING INJECTOR. DID NOT FALL. TAKEN OUT OF SVC.
LAB TECH. REPORTED THAT AN ABUTMENT SCREW KEPT LOOSENING. THE HEX ROUNDED OFF. THE DR ELECTED TO CUT OFF THE CROWN. PT IS SAME PT AS PRIOR MDR REPORT M764666.
NO OBSREVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HITORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.
DURING GRAFT SURGERY AT MEDICAL CTR, A BLOOD FLOW READING WAS TAKEN USING CO'S EQUIPMENT. THE FLOWMETER WAS LEFT CONNECTED IN THE OPERATING FIELD DURING THE FOLLOWING CAUTERIZATION PROCEDURE. THERE WAS FEEDBACK OF AN UNDETERMINED NATURE THAT CAUSED A SMALL FIRE IN THE METER POWER SUPPLY. THE FIRE DEPT WAS CALLED. THE PT WAS UNHARMED.
9/30/96: CO HAS COMPLETED THE FAILURE ANALYSIS OF THE HT107P-91-0040 FLOWMETER WHICH WAS INVOLVED IN AN OPERATING ROOM FIRE  ON 8/23/96. THE FLOWMETER WAS LEFT PLUGGED IN WHILE CAUTERY EQUIPMENT WAS IN USE, AND A SMALL FIRE OCCURRED IN THE POWER SUPPLY SECTION OF THE MOTHERBOARD. THE FAILURE WAS CAUSED BY A SHORT IN A CERAMIC CAPACITOR PLACED ACROSS A SECONDARY POWER BRIDGE RECTIFIER. THE SHORT CIRCUIT CURRENTS RESULTING FROM THIS SHORT OVERHEATED THE COPPER PC BOARD TRACING IN THE VICINITY OF THIS COMPONENT CREATING A NON-SUSTAINING FIRE. ALL INTERNAL FLOWMETER MATERIALS ARE FLAME RETARDANT. THE SPECIFIC COMPONENT AT C112B IS A CERAMIC .47 MFD. CAP, FACTORY RATED FOR 50V DC. IT CARRIES A 25V PEAK (18.6V RMS) UNDER NORMAL OPERATION OF NOMINAL LINE VOLTAGE, AND IS DESIGNED TO TAKE THE STRESS OF NORMAL OPERATION WITH A 2X SAFETY MARGIN. TWO POSSIBLE REASONS FOR THIS FAILURE CAN BE HYPOTHESIZED: 1. EMI/RFI FAILURE, FROM AN FRI SPIKE COMING INACROSS THE METER/S LINE POWER CORD: THIS METER MODEL USES ALL THE SAME POWER LINE COMPONENTS AS CO'S CURRENT HT107A MODELS WHICH PASSED EMISSIONS AND SUSCEPTIBILITY TESTING TO THE EUROPEAN EMC DIRECTIVE IN DECEMBER OF 1995. THEREFORE, A PRIMARY POWER SURGE RESPONSIBLE FOR THIS BREAKDOWN WOULD HAVE TO HAVE BEEN IN EXCESS OF THE TEST LIMITS IN THE HARMONIZED STANDARD EN50082-1. 2. RANDOM COMPONENT FAILURE DUE TO AGING: THIS IS THE FIRST SUCH FAILURE CO'S SEEN SINCE THIS COMPONENT WAS FIRST USED IN 1990. CO INSTALL 4 CAPACITORS ACROSS THE FOUR ARMS OF THE BRIDGE RECTIFIER IN EACH CHANNEL OF THE METER. CO ESTIMATES THAT CO HAS INSTALLED APPROX 10,000 SUCH CAPACITOS IN THE PAST 7 YEARS. THIS TYPE OF RANDOM BREAKDOWN WOULD DEFINITELY NOT BE TYPICAL OR SYMPTOMATIC OF A SYSTEMIC ISSUE. CONDUCTION OF AN ELECTRICAL SURGE FROM THE PT VIA CO'S PT CONNECTED FLOW-PROBE BACK INTO THE POWER LINE DIDNOT OCCUR. THE METER'S FRONT END IS EQUIPPED WITH DEFIB-PROOF TRANSFORMERS. A SURGE PASSING THROUGH THIS FRONT END WOULD FLOW OFF TO POWER LINE GROUND RATHER THAN THROUGH THIS CAPACITOR. ADDITIONALLY, THE PROBE THAT WAS CONNECTED WHEN THE FIRE OCCURRED WAS RETURNED WITH THE METER AND FOUND TO BE UNHARMED AND OPERATING NORMALLY. AT A MINIMUM, CO WOULD HAVE FOUND AN ERASED EPROM IN THE PROBE IF THE SURGE WERE INTRODUCED THROUGH THE PROBE. CO HAS REPLACED THE MOTHERBORAD, LINE TRANSFORMER AND RELATED CIRCUITRY IN THE HT107P-91-0040 AND HAS RETURNED IT TO FACILITY WITH THE UNAFFECTED FLOW PROBE. GENERIC, ACROSS-THE-BOARD, REMEDIAL ACTION DOES NOT APPEAR TO BE WARRANTED, ESPECIALLY IN LIGHT OF THE OTHER RF COMPATABILITY PROBLEMS THAT FACILITY'S ENGINEER SAID THAT THEY'D HAD WITH THE CAUTERY EQUIPMENT.
THE DEVICE WAS USED DURING A GASTRECTOMY. THE DEVICE WAS PLACED ON THE STOMACH AND WAS DIFFICULT TO CLOSE. IT IS NOT CLEAR IF THERE WAS TOO MUCH TISSUE IN THE JAWS. THE DEVICE WAS FIRED AND THE STAPLES WERE UNFORMED. IT IS NOT CLEAR IF THE ALIGNMENT PIN WAS PROPERLY SEATED IN THE ANVIL. THE STAPLES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH TWO FIRINGS OF ANOTHER MODEL. THERE WAS NO CONSEQUENCE TO THE PT.
FOLLOW-UP LETTER SENT TO FACILITY REQUESTING ADDITIONAL INFORMATION. RESULT OF EVALUATION: CONCLUSION: BASED ON THE INFORMATION RECIEVED AND THE VISUAL FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT OCCURRED DURING SURGERY. AS STATED IN THE CLINICAL FOLLOW-UP, IT APPEARS LIKELY THAT THE RETAINING PIN WAS NOT FULLY ENGAGED IN THE ANVIL HOLE. IT SHOULD BE NOTED THAT IN TORQUE IS APPLIED TO THE INSTRUMENT PRIOR TO ENGAGING THE RETAINING PIN, IT MAY CAUSE THE STAPLES TO NOT ALIGN PROPERLY WITH THE ANVIL AND CAUSE THE STAPLES TO BE MALFORMED. UPON RECEIPT, IT WAS NOTED THAT THE ADJUSTING KNOB WAS BROKEN OFF THE INSTRUMENT. THEREFORE, FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED. HOWEVER, DESPITE THE DAMAGE TO THE INSTRUMENT, THE INSTRUMENT WAS CYCLED SEVERAL TIMES WITH NO DIFFICULTIES NOTED WITH THE RETAINING PIN ENGAGING AS DESIGNED. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
SPINAL CORD TRAUMA. EROSION THROUGH CORPORA. DEVICE EXPLANTED 7/15/96.
PERIODONTIST STATED THAT HE SURGICALLY UNCOVERED PT'S IMPACTED UPPER RIGHT CUSPID AND BONDED A LINGUAL CLEAT TO IT; HE ALSO STATED THAT THIS IS ONE OF THE MORE COMMON PROCEDURES WHICH HE PERFORMS. AT A SUBSEQUENT APPOINTMENT, PERIODONTIST NOTED THAT PT HAD REMOVED THE ELASTOMERIC CHAIN ATTACHED TO THE LINGUAL CLEAT AND THAT THE CLEAT HAD SEPARATED FROM ITS BASE, LEAVING ONLY THE BASE OF THE LINGUAL CLEAT ATTACHED TO THE PT'S CUSPID TOOTH. PT'S CUSPID TOOTH HAD SUBSEQUENTLY RECEDED UNDER THE GUM TISSUE, WHICH REQUIRED A SECOND SURGICAL PROCEDURE IN ORDER TO REPLACE THE LINGUAL CLEAT. PERIODONTIST STATED THAT PT'S PROGNOSIS IS EXCELLENT.
D6, OTHER #: 425 IS A PACKAGING DATE CODE WHICH DENOTES THE DAY THIS PRODUCT WAS PACKAGED. THE PACKAGING DATE CODE FACILITATES TRACEABILITY OF THE PRODUCT. PART NUMBER 709-050.
DR REPORTED THAT A BRIDGE FUNCTIONED WELL FOR 5 YRS, PROBLEM; FRACTURE OF INTERNAL SCREW OF IMPLANT. DR WOULD NOT RETURN CALLS FOR INFO ABOUT EXACT PART NUMBER.
METHOD (86): PART NOT RETURNED. LOT INFO NOT AVAILABLE FROM DR.
ARM AND LEAD SHIELD CAME OFF ON THE MOUNT WHICH SUSPENDS FROM THE CEILING. PT WAS OUT OF THE ROOM, BUT IT JUST MISSED HITTING AN ASSOCIATE WHO WAS MOVING THE LEAD SHIELD OUT OF THE WAY. THE ARM AND SHIELD WEIGH APPROX 150 LBS.
THE INSTRUMENT WAS USED DURING A COLECTOMY. THE SURGEON RESECTED A PORTION OF THE SMALL BOWEL WITH A DEVICE AND PERFORMED A FUNCTIONAL END-TO-END ANASTAMOSIS. HE IMMEDIATELY NOTED SINIFICANT BLEEDING AND HAD TO OVERSEW AND USE CAUTERY TO CONTROL BLEEDING. REP RETURNING 3 RELOADS WITH THE INSTRUMENT. AN ADD'L 30-40 MINUTES WAS REQUIRED TO COMPLETE PROCEDURE. NO BUTTRESSING MATERIAL USED.
RISK MANAGEMENT RETURNED CALL. SHE WAS NOT AWARE OF THE EVENT. SHE STATED SHE WILL ATTEMPT TO SPEAK TO THE SURGEON AND LOCATE MORE INFO.
DR REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE WAS INTRODUCED THROUGH THE TROCAR AND UPON ATTEMPTING TO FIRE, THE DEVICE BEGAN TO SPIT CLIPS ON EACH ATTEMPT. THE CLIPS WERE RETRIEVED LAPAROSCOPICALLY FROM THE ABDOMEN. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
EES# 964021/CIN.  RESULTS OF EVALUATION: CONCLUSION BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
RESPIRATORY CARE PRACTITIONER COMPLAINED THAT THE MANUAL RESUSCITATOR TEE ADAPTER HAD HAIRLINE CRACKS THEREBY CAUSING A LOOSE CONNECTION AND/OR A LEAK. DURING INVESTIGATION IT WAS NOTED THAT THIS PROBLEM INVOLVED MANY LOT CODE NUMBERS. PRODUCT WAS PULLED FROM STOCK.
WHEN SCREWING IN A 40 MM 4.5 SCREW WITH THE BATTERY SCREWDRIVER, THE HEAD OF THE SCREW BROKE OFF. ATTEMPTS TO GET THE THREADED PORTION OUT FAILED, SO IT WAS LEFT IN.
PT SAMPLE MESURED A SALICYLATE OF <1MG/DL (NEGATIVE) USING CO SALICYLATE SLIDES. RESULT REPORTED TO PHYSICIAN. PHYSICIAN REQUESTED A REPEAT OF THE TEST. A FRESH PT SAMPLE WAS DRAWN AND MEASURED USING THE SAME CARTRIDGE OF SLIDES. RESULT WAS 3.0 MG/DL (THERAPEUTIC RANGE). A NEW CARTRIDGE WAS LOADED AND CALIBRATED ON INSTRUMENT. ORIGINAL SAMPLE AND RE-DRAW WERE RUN USING NEW CARTRIDGE. ORIGINAL SAMPLE GAVE 52MG/DL AND RE-DRAW GAVE 47 MG/DL. BOTH RESULTS ARE IN THE TOXIC RANGE FOR SALICYLATE. PHYSICIAN STATED THAT THERE WERE NO ADVERSE EFFECTS DUE TO THE MISREPORTED RESULTS.
A TOTAL OF 15 SLIDE CARTRIDGES (270 SLIDES) WERE RETURNED TO CO FOR EVALUATION. THE SLIDES WERE TESTED USING A QUALITY CONTROL FLUID, LOT NUMBER G1272. ALL 270 SLIDES TESTED GAVE RESULTS BETWEEN 12.5 TO 13.2 MG/DL. ALL SLIDES TESTED WERE WITHIN THE EXPECTED QUALITY CONTROL RANGE. PRODUCT PERFORMED WITHIN SPECIFICATIONS. ALLEGED FAILURE COULD NOT BE DUPLICATED.
THREE YRS POST RESTORATION, THE ABUMENT AT SITE 46 (19 U.S.) FRACTURED. THE FRACTURE WAS DISCOVERED DURING ROUTINE FOLLOW-UP VISIT. THE ABUTMENT WAS REPLACED WITH A NEW ONE DURING SAME VISIT. PT IS SAME PT AS PRIOR MDR REPORT #M350645.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FORM THE DOCTOR'S OFFICE.
THE LIFT STOPPED WORKING WHILE PT WAS BEING LOWERED. THE EMERGENCY BUTTON DID NOT WORK. IT TOOK FOUR MEN TO MANUALLY LOWER PT INTO BED AND ONE OF THEM HURT HIS SHOULDER.
THE DEVICE WAS APPLIED DURING A TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY AND THE SURGEON HAS TO RESECT THE STAPLE LINE. THE PROCEDURE WAS COMPLETED BY MANUAL SUTURE.
9/16/96-MEDWATCH REPORT NOT RECEIVED BY MFG. INITIAL REPORT SENT TO FDA BY MFG.
THE APPLIER WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS WERE SCISSORING. THE VESSELS OR DUCTS WERE NOT SEVERED. THE SCISSORED CLIPS WERE REMOVED LAPAROSCOPICALLY. A SECOND DEVICE WAS INTRODUCED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
F1:USER FACILITY BOX WAS INCORRECTLY CHECKED ON THE INITIAL MEDWATCH. NO USER FACILITY MEDWATCH WAS RECEIVED.G3:CONSUMER WAS INCORRECTLY SELECTED ON THE INITIAL MEDWATCH.
NO LUMEN AT END OF CATHETER INSERTED INTO BLADDER; THEREFORE, COULD NOT BE IRRIGATED AND COULD NOT DRAIN URINE. THIS PROBLEM WAS FOUND WHEN CATHETER WAS CHANGED DUE TO NO URINE OUTPUT.
CUSTOMER RINSED HANDS, OPENED NEW BOTTLES OF SAPS; RINSED CONTACTS AND PLACED THEM IN HIS EYES. EYES BEGAN TO BURN. WASHED EYES WITH UNK WITH CONTACTS IN PLACE. BURNING WORSENED. REMOVED CONTACTS AND PLACED THEN IN "CLEAN VIALS." CUSTOMER WAS TAKEN TO LOCAL ER BY PARENTS-COULD NOT SEE AT THAT TIME. ER PHYSICIAN PUT UNK MEDICATION IN BOTH EYES, BANDAGED RIGHT EYE AND GAVE CUSTOMER UNK MEDICATION TO PUT IN LEFT EYE EVERY 4 HOURS. DIAGNOSIS -BURNED CORNEAS, RECOMMEND REFERRAL TO SPECIALIST. SPECIALIST CONFIRMED BOTH CORNEAS BURNED; PRESCRIBED DIFF UNK MEDICATION AND TOLD CUSTOMER DISCOMFORT WOULD LAST APROX 1 WEEK. NO PERMANENT DAMAGE REPORTED.
PRODUCT MET ALL RELEASE SPECIFICATIONS; BATCH REVIEW COMPLETED 8/27/96. SAMPLE HAS NOT BEEN RETURNED BY THE CUSTOMER TO DATE. FINISHED PRODUCT RETAIN TEST RESULTS WERE WITHIN SPECIFICATION. LABEL INDICATES THAT THIS PRODUCT MAY CAUS IRRITATION.
THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT STAPLE LINE WAS NOT COMPLETE. THE SURGEON RESECTED TISSUE AND COMPLETED THE PROCEDURE BY MANUAL SUTURE.
9/16/96-MEDWATCH REPORT NOT RECEIVED BY MFR. INITIAL REPORT SENT TO FDA BY MFG.
NO LUMEN AT END OF CATHETER INSERTED INTO BLADDER; THEREFORE, COULD NOT BE IRRIGATED AND COULD NOT DRAIN URINE. THIS PROBLEM WAS FOUND WHEN CATHETER WAS CHANGED DUE TO NO URINE OUTPUT AND DIFFICULTY WITH IRRIGATION.
THE PORT CATHETER WAS REPORTED TO HAVE RUPTURED. NO OTHER INFO IS AVAILABLE.
ATOMIZER WORKING IMPROPERLY. DOES NOT WHISTLE WHEN USED INCORRECTLY.
THIS IS THE SAME PT/EVENT AS MFR# 2219689-1996-00067. SUMMARY OF EVAL:AS RECEIVED, THE TIBIAL INSERT EXHIBITS MODERATE WEAR ON BOTH CONDYLES WITH A PREFERENCE TO THE LATERAL-POSTERIOR QUADRANT. THE WEAR PATTERN SUGGESTS AN INTERNAL MAL ROTATION AND/OR A PT ABNORMAL GAIT. THE PATELLAR COMPONENT IS IN GOOD CONDITION SHOWING ONLY MINOR SURFACE SCRATCHES AND A FEW VERY SMALL PITS. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PATELLAR COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE LOT CODE FOR THE TIBIAL COMPONENT HAS NOT BEEN SUPPLIED AND IS NOT VISIBLE ON THE PART SO THAT A REVIEW OF ITS DEVICE HISTORY RECORD IS NOT POSSIBLE. THE INFO PROVIDED AND THE EXAM RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALLIGNMENT OR PT GAIT.
PT UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTY AT ANOTHER FACILITY. HE  REPORTED THAT HE HAS PAIN AND SWELLING IN HIS KNEES INCREASING WITH        ACTIVITIES SINCE THE SURGERY. PT PRESENTED WITH 2-3+ EFFUSION IN HIS LEFT KNEE. HE REPORTED PAIN ALONG THE LATERAL JOINT LINE. HIS DAILY LIVING ACTIVITIES WERE MARKEDLY DECREASED. THE PT WAS ADMITTED TO THE HOSP FOR REVISION OF THE LEFT TOTAL KNEE. INTRAOPERATIVELY, THERE WAS BONY INGROWTH ON BOTH THE FEMORAL AND TIBIAL SIDE ALTHOUGH IT WAS INCOMPLETE ON BOTH. AS WELL AS ON THE PATELLA. A SYNOVECTOMY OF THE KNEE WAS CARRIED OUT AND IMMEDIATELY ENCOUNTERED WERE FRAGMENTS OF POLYETHYLENE. THERE WAS FRAGMENTATION AND WEAR OF BOTH THE PATELLA AND BOTH THE MEDIAL AND LATERAL INSERT. THE TOTAL KNEE COMPONENTS WERE REPLACED WITH ANOTHER TYPE OF DEVICE AND CEMENTED.
INTRACAPSULAR RUPUTRE OF IMPLANT. UNSURE OF POSSIBLE COMPLICATIONS.
THE PORT WAS PLACED 3/15/96 FOR CHEMOTHERAPY. ON 8/8/96, THE PORT WAS REMOVED DUE TO CATHETER LEAKAGE. THE REPORTER SAID IT APPEARED THAT THE CATHETER HAD BEEN PARTIALLY SEVERED BY CLAVICLE-1ST RIB COMPRESSION. THE CATHETER DID NOT BREAK OFF AND EMBOLIZE.
IMPRESSIONS ON THE CATHETER COMMON TO HEMOSTAT GRIP MARKS WERE FOUND .6" PROXIMAL TO THE BREAK SITE. THE BREAK APPEARED JAGGED AND TORN WITH A ROUGH BUT GLOSSY SURFACE. IT APPEARED THE TUBING MAY HAVE BEEN NICKED WITH A SHARP INSTRUMENT AND/OR CUT WITH THE SUTURE FILAMENT. NO SUTURE TRAILS WERE NOTED IN THE PORT, ONLY ON THE CATHETER. THE PORT DID NOT APPEAR TO HAVE BEEN PROPERLY ANCHORED TO THE PORT POCKET. NATURAL MOVEMENTS INSIDE THE BODY COULD CAUSE THE SUTURE FILAMENT TO CUT THE TUBING.
THE PORT WAS PLACED 7/1/96 IN THE LEFT SUBCLAVIAN. A DYE STUDY WAS DONE WHICH SHOWED THE CATHETER HAD BROKEN AWAY FROM THE PORT AND LODGED IN THE PT'S VENTRICLE. THE CATHETER FRAGMENT WAS SNARED OUT IN RADIOLOGY.
THE BREAK SITE WAS LOCATED APPROXIMATELY 1.5" PROXIMAL TO THE FOURTH DEPTH MARK. ONE HALF OF THE BREAK APPEARED SMOOTH & GRANULAR & THE OTHER HALF APPEARED JAGGED & ROUGH. IT APPEARED THAT THE TUBING MAY HAVE BEEN DAMAGED BY A BLUNT INSTRUMENT, SUCH AS HEMASTATS, THEN CUT BY THE SUTURE FILAMENT THROUGH THE NATURAL MOVEMENT THAT OCCURS INSIDE THE BODY.
THE BREAK SITE WAS LOCATED APPROXIMATELY 1.5" PROXIMAL TO THE FOURTH DEPTH MARK. ONE HALF OF THE BREAK APPEARED SMOOTH & GRANULAR & THE OTHER HALF APPEARED JAGGED & ROUGH. IT APPEARED THAT THE TUBING MAY HAVE BEEN DAMAGED BY A BLUNT INSTRUMENT, SUCH AS HEMOSTATS, THEN CUT BY THE SUTURE FILAMENT THROUGH THE NATURAL MOVEMENT THAT OCCURS INSIDE THE BODY.
THE APPLIER WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS WERE FALLING OUT OF THE INSTRUMENT. THE CLIPS WERE REMOVED LAPAROSCOPICALLY. A SECOND DEVICE WAS INTRODUCED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D5,10;H4: INFORMATION UNAVAILABLEF1: SHOULD NOT HAVE BEEN CHECKED ON INITIAL MEDWATCH. NO MEDWATCH WAS RECEIVED BY USER FACILITY. G3: HEALTH PROFESSIONAL WAS INCORRECTLY SELECTED IN INITIAL MEDWATCH. BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND A FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THIS INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
ADD'L INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED FROM THE USER FACILITY. THE BASELINE REPORT SHALL BE SUBMITTED UPON RECEIPT OF TEH COMPLETE C/N WITH THE SUPPLEMENTAL MEDWATCH REPORT. THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FROM THE REPORTED WEAR AS THEY HAVE BEEN RETURNED TO CO AS IT IS IN OPPOSITION TO HOSP POLICY. THE C/N AND LOT CODES HAVE BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE, C/N AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL.
THE INSTRUMENT WAS NOT CLINICALLY APPLIED. REPORTED, THE INSTRUMENT BROKE UPON REMOVAL FROM PACKAGE.
THIS EVENT IS NOT REPORTABLE AS A MALFUNCTION IN ACCORDANCE WITH THE MDR REGULATION. PLEASE DISREGARD THE EVENT SUBMITTED UNDER THIS REFERENCE NUMBER.
THE INSTRUMENT WAS NOT CLINICALLY APPLIED. REPORTEDLY, THE INSTRUMENT BROKE UPON REMOVAL FROM PACKAGE.
IT HAS COME TO OUR ATTENTION THAT THIS EVENT IS NOT REPORTABLE AS A MALFUNCTION IN ACCORDANCE WITH THE MDR REGULATION. PLEASE DISREGARD THE EVENT SUBMITTED UNDER THIS REFERENCE NUMBER.
THE CATHETER WAS REMOVED FROM THE PT DUE TO OCCLUSION. AFTER REMOVAL, AN X-RAY SHOWED AN APPROXIMATELY 1" CATHETER FRAGMENT IN THE PT'S HEART. THE FRAGMENT IS REPORTED TO STILL BE IN THE PT.
AN EVAL OF THIS DEVICE IS NOT POSSIBLE AS THE HOSP IS RETAINING THE DEVICE.
THE DEVICE WAS APPLIED A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SCOPE'S VISIBILITY WAS UNCLEAR. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
DURING CATHETER PLACEMENT ON 8/9/96, THE PT COMPLAINED OF PAIN AS THE CATHETER WAS BEING THREADED. THE CATHETER WAS ONLY ABLE TO BE INSERTED UP TO THE AXILLARY VEIN. THE CATHETER WAS LEFT IN AS TWHERE WAS NO PAIN WITH FLUSHING.
THREE SAME-LOT SAMPLES WERE RETURNED FOR EVALUATION. ALL TRAY SEALS WERE EXAMINED AND FOUND TO BE COMPLETELY INTACT. EACH CATHETER WAS THREADED THROUGH AN INTRODUCER WITH NO RESISTANCE AND THE GUIDEWIRES WERE REMOVED WITHOUT DIFFICULTY. NO SURFACE IRREGULARITIES WERE NOTED UNDER MAGNIFICATION. THE CATHETERS WERE PRESSURIZED TO ABOVE 40PSI ADN NO LEAKS WERE SEEN. THE CATHETERS FLUSHED AND ASPIRATED NORMALLY. THE CATHETERS WERE FOUND TO BE FREE OF ABNORMALITIES AND FUNCTIONED NORMALLY.
DURING CATHETER PLACEMENT ON 8/9/96, THE PT COMPLAINED OF PAIN AS THE CATHETER WAS BEING THREADED. THE CATHETER WAS ONLY ABLE TO BE INSERTED UP TO THE AXILLARY VEIN. THE CATHETER WAS LEFT IN AS THERE WAS NO PAIN WITH FLUSHING.
THREE SAME-LOT SAMPLES WERE RETURNED FOR EVALUATION. ALL TRAY SEALS WERE EXAMINED AND FOUND TO BE COMPLETELY INTACT. EACH CATHETER WAS THREADED THROUGH AN INTRODUCER WITH NO RESISTANCE AND THE GUIDEWIRES WERE REMOVED WITHOUT DIFFICULTY. NO SURFACE IRREGULARITIES WERE NOTED UNDER MAGNIFICATION. THE CATHETERS WERE PRESSURIZED TO ABOVE 40PSI AND NO LEAKS WERE SEEN. THE CATHETER FLUSHED AND ASPIRATED NORMALLY. THE CATHETERS WERE FOUND TO BE FREE OF ABNORMALITIES AND FUNCTIONED NORMALLY.
DURING PLACEMENT, THE DR WAS REMOVING THE GUIDE WIRE AND IT FRAYED. THE "J" HOOK WAS REPORTED TO HAVE BROKEN OFF AND EMBOLIZED TO THE PT'S HEART.
THE HOSP IS APPARENTLY RETAINING THE DEVICE, SO AN EVAL WAS UNABLE TO BE COMPLETED.
THE ATTENDING SURGEON NOTED BLEEDING ALONG STAPLE LINE DURING PROCEDURE AND HAD TO TAKE ADD'L STEPS TO ACHIEVE HEMOSTASIS. NO BUTTRESSING MATERIAL USED. 8/6/96 THE STAPLE LINES WERE OVERSEWN AND ELECTROCAUTERY WAS USED TO CONTROL THE BLEEDING. NO BUTTRESSING MATERIAL WAS USED.
A1,2,3,4;B6,7;D10: INFORMATION UNAVAILABLE. D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
RPTR HAS BEEN HAVING REDDENED HANDS WITH USE OF LATEX GLOVES AT WORK. THIS HAS BEEN OCCURRING SINCE 1992. HAVE BEEN TO SEVERAL DOCTORS, ALLERGISTS, DERMATOLOGISTS ETC. RPTR'S HANDS HAVE BURNED SO BADLY SHE DOESN'T WANT TO USE GLOVES DURING PT CARE, ETC. RPTR WAS PUT OUT OF WORK FOR 2 DAYS UNTIL THE ENVIRONMENT COULD BE EVALUATED FOR LATEX CONTACTS. RPTR HAS HAD SEVERAL SINUS SURGERIES THAT SHE WAS TOLD COULD BE RELATED TO CONTACT WITH LATEX PRODUCTS.
A 6 FT TALL ICU PT WEIGHING 154 LBS SUSTAINED BURNS AND BLISTERS TO HIS LT LATERAL HEEL AND RT LATERAL FOOT FROM THE BED MOTOR. THE PT WAS VENTILATOR DEPENDENT AND UNCONSCIOUS.
PT ADMITTED TO HOSP COMPLAINING OF HIGH BLOOD SUGAR. AS HE WAS ON CONTINUOUS INSULIN INFUSION THERAPY USING THE INSULIN PUMP, A MALFUNCTION WAS SUSPECTED. THE PT WAS INSTRUCTED TO CHANGE THE VIAL OF INSULIN CURRENTLY IN THE PUMP TO ELIMINATE THE DRUG AS THE CAUSE OF THE HIGH BLOOD SUGAR. AFTER THE CHANGE, THE PT'S BLOOD SUGAR RETURNED TO NORMAL.
RESULTS OF THE EVALUATION PERFOMED WHILE ON THE PHONE WITH THE PT INDICATED THE PUMP WAS OPERATING CORRECTLY. REPLACEMENT OF THE INSULIN VIAL RESOLVED THE PT'S HIGH BLOOD SUGAR CONDITION. INSULIN CAN LOSE ITS POTENCY IF NOT STORED PROPERLY OR IF USED AFTER ITS EXPIRATION DATE. SUBMISSION OF THIS REPORT IS DUE TO THE PT REQUIRING HOSPITALIZATION FOR HIGH BLOOD SUGAR WHILE ON INSULIN PUMP THERAPY, IT CAN BE CONCLUDED THAT USING INSULIN THAT HAS LOST ITS POTENCY IS INFO THAT REASONABLY SUGGESTS THE DEVICE (INSULIN PUMP IN THIS CASE) MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S SERIOUS INJURY BECAUSE OF "USER ERROR."
THE DEVICE WAS USED IN A LOW ANTERIOR RESECTION. IT WAS REPORTED, AFTER TYING THE PURSE STRING, THE CDH29 WAS INSERTED AND FIRED. A DONUT WAS CREATED AT ONLY THE DISTAL END OF THE PROXIMATE SIDE OF THE ANASTOMOSIS. THE DISTAL DONUT DID NOT CUT, NOR DID ANY STAPLES FORM ON EITHER SIDE. THE DEVICE INSTRUMENT SIDE WAS EXCISED FROM THE PT. THE INITIAL SITE WAS APPROXIMATELY 4 CM FROM THE ANUS AND THE SURGEON DISSECTED MORE TO ACCESS ENOUGH TISSUE FOR A SECOND ANASTOMOSIS. THIS EXTENDED THE PROCEDURE ABOUT TWO ADD'L HRS. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6; H3,4,6;G4: ADDED ADDITIONAL INFO. D6; DEVICE RETURNED WITH NO LOT ID. CONCLUSION: NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS TESTED AND FIRED AND FORMED STAPLES AS DESIGNED AROUND THE ENTIRE STAPLE RING. ADDITIONALLY, THERE WAS A GOOD CUT ON THE TEST MEDIA. THE INCIDENT THAT OCCURRED DURING SURGERY COULD NTO BE RECREATED. BASED ON THE INFO PROVIDED ON THE CLINICAL FOLLOW-UP, IT APPEARS POSSIBLE THAT THE ANVIL MAY NOT HAVE BEEN LOCKED PROPERLY ONTO THE TROCAR. IF THE ANVIL HAD BEEN ATTACHED PROPERLY, IT WOULD HAVE REMAINED ATTACHED TO THE TROCAR UPON REMOVAL. ADDITIONALLY, IF THE ANVIL IS NOT LOCKED SECURELY ONTO THE INSTRUMENT, IT MAY NOT PROVIDE THE CUTTING SURFACE NEEDED TO A CUT THROUGH BOTH PROXIMAL AND DISTAL DONUTS. THIS WOULD ALSO CONTRIBUTED TO MALFORMED STAPLES AS THE STAPLE WOULD NOT ADEQUATELY ALIGN AGAINST THE ANVIL POCKETS FOR PROPER STAPLE FORMATION. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
PT UNDERWENT CATARACT SURGERY ON 8/28/96, AND IMPLANTATION OF AN INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON WAS NOT SURE IF THE LENS EJECTED IN A CONTROLLED MANNER. THE POSTERIOR CAPSULE WAS FOUND TO HAVE A TEAR IN IT AND THE SURGEON PERFORMED A VITRECTOMY. DATE DEVICE EXPIRES: 1/4/2001.
H.6. RESULTS OF EVALUATION: NO DEFECTS WERE PRESENT THAT WOULD INDICATE THAT THE LENS EJECTED IN AN UNCONTROLLED MANNER AND TORE THE POSTERIOR CAPSULE. THE PT'S PREOPERATIVE VISUAL ACUITY WAS 20/50 CORRECTED AND INTRAOCULAR PRESSURE WAS 15MM HG. NO COMPLICATIONS NOTED AND NO OTHER SURGICAL PROCEDURES WERE PERFORMED. THE PT RECEIVED ANOTHER REPLACEMENT LENS, MODEL C421F5. THE PT'S PROGNOSIS IS GOOD AND SHE IS IMPROVING. THE RATE OF OCCURRENCE OF THIS EVENT CANNOT BE DETERMINED AS IT IS NOT ADDRESSED IN THE PRODUCT LABELING. LENS BOX WAS RECEIVED. THE BOX CONTAINED 7 CHART LABELS, THE PT ID CARD, PT REGISTRATION CARD, ELASTIC LENS PRODUCT INFO BOOKLET, AND LENS TRAY. THE LENS TRAY CONTAINED THE BASE AND TIP INSERT, WITH THE LENS LOCATED IN BETWEEN THE INSERTS. TAPE WAS HOLDING THE LENS AND INSERTS WITHIN THE TRAY. THE LENS WAS REMOVED FROM BETWEEN THE INSERTS AND INSPECTED FOR DEFECTS THAT MAY HAVE CAUSED THE LENS TO EJECT IN AN UNCONTROLLED MANNER AND CAUSE A POSTERIOR CAPSULE TEAR. THE LENS HAS DRIED BLOOD AND BSS/VISCOELASTIC RESIDUE PRESENT. THE LENS WAS INSPECTED ACCORDING TO SPECIFICATIONS. NO DEFECTS ARE PRESENT THAT WOULD INDICATE THIS LENS EJECTED IN AN UNCONTROLLED MANNER.
FACILITY ALLEGED: ON THE NINTH USE, THE ARTERIAL BLOODLINE TUBING SPLIT INSIDE THE BLOOD PUMP WHILE TREATMENT WAS IN PROGRESS. ACTUAL SAMPLE SAVED FOR EVALUATION. ESTIMATED BLOOD LOSS: 140CC. PT HEMATOCRIT 31.9 FROM 33.0% BEFORE INCIDENT.
THE MAJOR CAUSE OF PUMP SEGMENT SPLITTING IS INCORRECT SETTING OF THE PUMP SEGMENT IN THE PUMP ROTOR ASSEMBLY. THE INSTRUCTION INSERTS THAT ACCOMPANY ALL ARTERIAL BLOOD LINES WERE REVISED TO INCLUDE A CHECK FOR PROPER SET-UP OF THE PUMP SEGMENT AND INSPECTION OF THE BLOOD PUMP HOUSING FOR WEAR. FOR THE REUSE LINES, THE PUMP SEGMENT MUST BE CHECKED BEFORE AND AFTER EACH REUSE FOR ANY VISUAL DEFECTS OR SHAPE CHANGING. IF SERIOUS DEFECTS ARE NOTICED, BLOOD LINE MUST BE REJECTED. SINCE THIS LINE WAS IN ITS NINTH USE, COMMON SIGNS OR WEAR WERE NOTED IN THE PUMP SEGMENT.
THE UNIT OVERFILLED A FINAL CONTAINER. THIS WAS BASED ON THE 1000ML CONTAINER APPEARING TO THE USER TO BE VERY FULL "BURSTING AT THE SEAMS" WHEN THE UNIT HAD BEEN PROGRAMMED TO DELIVER 1000ML. THE CALLER DID NOT KNOW THE VOLUMES PROGRAMMED ON EACH STATION, ONLY THE TOTAL VOLUME. THE BAG WAS THE FIRST ONE OF THE DAY TO BE COMPOUNDED. THE USER STATED THAT THE TRANSFER SET HAD NOT BEEN PRESTRETCHED AND THE ROTORS HAD BEEN TURNED. THERE WERE NO ALARMS. NO PT INVOLVEMENT. THE UNIT WAS SWAPPED OUT AT THE REQUEST OF THE USER.
EVALUATION: THE UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
FACILITY REPORTED: PT HAD DIALYZED ON 8/6/96 AFTERNOON AND WAS ADMITTED ON 8/7/96 EARLY AM IN THE HOSP WITH DIAGNOSTIC OF HEMOLYSIS. DIALYSIS BELIEVED TO BE THE CAUSE OF HEMOLYSIS. NO KINKS WERE NOTED ON #3 15GA NEEDLES AND BFR400CC/MIN USED.
THE DEVICE HISTORY RECORD (9/13/96) SHOWED NO INDICATION OF THIS DEFECT.  THE LOT MET ALL RELEASE CRITERIA. THERE ARE MANY CLINICAL INFLUENCES WHICH CAN CAUSE HEMOLYSIS, SUCH AS CONTAMINANTS IN THE DIALYSIS SOLUTION (CHLORAMINE, COPPER, ZINC, NITRATES, FORMALDEHYDE OR BLEACH), TEMPERATURE OF THE DIALYSIS SOLUTION, OSMOLARITY OF THE DIALYSIS SOLUTION, REUSE STERILANTS, PT MEDICAL CONDITION OTHER THAN ESRD AND MORE. IN ADDITION  LABORATORY TESTS REVEAL THAT KINKS IN THE MAIN BLOOD LINE MUST BE VERY SEVERE (85% OCCLUSION AT BLOOD TEMPERATURE) TO CAUSE HEMOLYSIS.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SCOPE'S VISIBILITY WAS UNCLEAR. THE HOSP HAS REPORTED NO PT INJURY.
9/24/96-CORRECTED INFORMATION SUBMITEED FOR B-4, D-5 NAD F-8. ADDITIONAL INFORMATION SUBMITTED FOR D-9. DEVICE EVALUATION INDICATED AND CODES ENTERED FOR H-3 AND H-6.
AFTER A NO FLOW ALARM, THE UNIT WAS MANUALLY PROGRAMMED TO DELIVER 100ML FROM STATION 3, BUT INSTEAD STATION 6 BEGAN TO PUMP AND CALLER CLAIMED THAT THE TOTAL DELIVERED DISPLAY AND VOLUME DELIVERED DISPLAY ON STATION 3 WERE SHOWING INCREASES. AT THIS POINT, COMPOUNDING WAS DISCONTINUED AND THE BAG WAS DISCARDED, SO THERE WAS NO PT INVOLVEMENT. UNIT WAS TAKEN OUT OF SERVICE AND SWAPPED OUT.
EVALUATION: THE UNIT WAS RECEIVED DIRTY AND TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY INVOLVING ONE PT. REPORTEDLY, THE UNIT LEAKED CO2 DURING THE PROCEDURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
THE PUMP WAS MISPROGRAMMED; INFO FROM THE PREVIOUS DAYS PROGRAM WAS USED INADVERTANTLY. THE PT WAS TRANSFERRED TO ANOTHER UNIT WHERE THE INFO PROGRAMMED IN THE PUMP WAS FOUND TO BE DISCREPANT. THE PT RECEIVED AN OVERINFUSION FROM APPARENT MISPROGRAMMING OF THE DEVICE. THE PT WAS HYPOTENSIVE AND HAD A MORPHINE TOLERANCE. THE PT DID NOT SUFFER ANY SIGNIFICANT EVENTS OR TREATMENT RELATED TO THIS OVERINFUSION. THE PUMP IS NOT BEING SENT IN FOR EVALUATION SINCE THE CUSTOMER DETERMINED IT WAS USER ERROR.
H.6. DEVICE NOT RETURNED FOR EVALUATION SINCE THIS EVENT WAS DETERMINED BY REPORTER TO BE USER ERROR RELATED. INFO IN SECTION F COMPLETED BY CO. F.10. CODE 1914 NOT LABELED. CODE 2199 NOT LABELED. CODE 1311 LABELED.
THE UNIT WAS DELIVERING ON EVERY STATION WITHOUT ANY ALARMS. THERE HAD BEEN NO PROBLEM WITH CALIBRATION. DURING TROUBLESHOOTING, THE USER REALIZED THAT WHEN SHE HAD CHANGED THE TRANSFER SET, SHE HAD NOT SNAPPED THE WEIGHING CHAMBER IN ALL THE WAY. WHEN THIS WAS DONE, THE UNIT COMPOUNDED WITHOUT ANY PROBLEMS. SINCE THE ISSUE WAS RESOLVED BY TELEPHONE THE UNIT WAS NOT SWAPPED OUT. NO PT INVOLVEMENT.
SECTION F COMPLETED BY CO BASED ON INFO RECEIVED FROM THE REPORTER. EVALUATION: THE USER WAS ADVISED OF THE CAUSES OF FREE FLOW, AND TOLD TO SNAP THE WEIGHING CHAMBER IN PLACE. THIS RESOLVED THE ISSUE. SINCE THE ISSUE WAS RESOLVED OVER THE TELEPHONE, THE UNIT WAS NOT RETURNED FOR EVAL. THE COMPLAINT WAS DUE TO USER TECHNIQUE ERROR.
ON 8/1/96, AT 4:32 PM, THE PT CODED. AN ABC ALERT WAS CALLED AT THE ICU. THE DEFIB WAS TAKEN TO BED AND TURNED ON. IT WAS THEN SET TO 360 JOULES; THE CHARGE BUTTON WAS PRESSED. THE DEFIB CHARGED NORMALLY TO THE CORRECT SETTING, THE PADDLES WERE PLACED ON THE PT'S CHEST AND THE DISCHARGE BUTTONS ON THE PADDLES WERE PRESSED. AT THIS TIME THE UNIT ALLEGEDLY DID NOT DISCHARGE. THE UNIT WAS CHARGED TWO MORE TIMES TO 360 JOULES AND BOTH TIMES IT ALLEGEDLY DID NOT DISCHARGE. AT THIS TIME ANOTHER DEFIB WAS BROUGHT IN AND CHARGED TO 360 JOULES. WITH THIS DEFIB THE ENERGY WAS DELIVERED AND THE PT WAS RESUSCITATED AT THAT TIME. THE PT WAS STABILIZED AND ALERT AFTER THE PROCEDURE. SHE WAS TRANSFERRED TO ANOTHER CTR ABOUT AN HOUR LATER (THIS WAS A PLANNED TRANSFER). THIS OCCURRED IN LESS THAN THREE MINUTES WITH NO ADVERSE EFFECTS TO THE PT.
THE CE CHECKED THE 43100A OUT ON 8/2/96 AFTER BEING CONTACTED BY MEDICAL DISPATCH. HE COULD NOT DUPLICATE THE PROBLEM BY MEDICAL DISPATCH HE COULD NOT DUPLICATE THE PROBLEM AND THE UNIT PASSED ALL SAFETY AND PERFORMANCE TESTS. FOR CUSTOMER SATISFACTION, HE REPLACED THE PADDLE SET FOR POSSIBLE INTERMITTENT PROBLEM.
A BALLOON BURST ON THE FIRST INFLATION AT FOUR ATMOSPHERES DURING A FEMORAL ANGIOPLASTY PROCEDURE. A SECOND BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. HOWEVER, UNTIL COMPLETION OF THE ENGINEERING EVALUATION CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
DEVICE WAS RETURNED, EVALUATED AND RETAINED BY MFR. THE ENGINEERING EVAL REVEALED A PIN-HOLE LOCATED AT THE PROXIMAL PORTION OF THE BALLOON AS WELL AS SCRAPE MARKS LEADING DIRECTLY UP TO THE HOLE. THE BALLOON SURFACE APPEARED CRUSHED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. ALTHOUGH FOLLOW UP DID NOT INDICATE ANY CALFICATION WAS PRESENT, THE ENGINEERING EVALUATION REVEALED CHARACTERISTICS CONSISTENT WITH A SHARP SOURCE, SCRAPE MARKS AND A CRUSHED BALLOON SURFACE. THEREFORE CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE.
USER FROM ACCOUNT CALLED TO REPORT AN INCIDENT THAT OCCURRED MORE THAN A MONTH EARLIER WHEN HE SAID THEY HAD PROGRAMMED STATION 4 FOR 300 ML BUT IT DELIVERED 400 ML. THE CALLER COULD NOT STATE HOW THIS WAS DETERMINED. AT THE TIME, STATION 5 WAS USED IN PLACE OF STATION 4 SINCE IT WAS AVAILABLE. THE CALLER STATED THAT THERE WAS NO PT INVOLVEMENT. THE UNIT WAS TAKEN OUT OF SERVICE AND SWAPPED OUT.
THE UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL ACCURACY TESTS, HOWEVER IT FAILED SHIELD CONTINUITY TEST DUE TO SOLUTION SPILLS. THE COMPLAINT OF OVERDELIVERY COULD NOT BE DUPLICATED.
THE CONNECTOR BROKE IN 2 PIECES WHILE IT WAS USED IN A PT BEING CARED FOR IN THE ICU. THE CONNECTOR WAS USED BETWEEN A DRAINPACK AND A THORACIC TROCAR WITH SUCTION. AS A RESULT OF THE TUBE BREAKAGE, THE PLEURAL CAVITY MAY HAVE BEEN EXPOSED TO THE OUTSIDE ENVIROMENT.
THE ACTUAL SAMPLE WAS RETURNED ALONG WITH 39 OTHER SAMPLES. PRODUCT FROM 16 DIFFERENT LOTS WAS ALSO EVALUATED. ONE SAMPLE BROKE BELOW THE 50LB SPEC. MANUFACTURING TESTED 900 ADD'L SAMPLES; ONE SEPARATED BELOW SPEC. NEITHER OF THE SAMPLES FOUND TO BE BELOW SPEC WERE FROM THE COMPLAINT LOT. VENDOR FEELS AN OPERATOR FAILED TO REMOVE CONNECTORS AFTER A WARNING ALARM SOUNDED ON THE WELDING MACHINE. THE VENDOR MODIFIED THEIR PROCEDURES AND TEST METHODS TO PREVENT RECURRENCE. THEY HAVE ALSO ORDERED AN EQUIPMENT MODIFICATION TO EJECT QUESTIONABLE PRODUCT. CO HAS INITIATED AN INCOMING INSPECTION FOR VISUAL AND FUNCTIONAL REQUIREMENTS. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED ON THIS PRODUCT. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCT HAS MALFUNCTIONED.
ANALYSIS REVEALED THAT THIS UNIT HAD INACCURATE DELIVERY DUE TO LOW MOTOR TORQUE. HYBRID FAILED TESTING DUE TO CRACKED COMPONENT.
ACCOUNT REPORTS THREE INCIDENTS IN WHICH DURING USAGE, THE TUBING/CUFF CONNECTION SEPARATED. ALL THREE INCIDENTS OCCURRED ON THE SAME PT. REPORTER STATED VERY LOW PRESSURE WAS BEING CREATED. PER REPORTER, "BLOOD SQUIRTED ALL OVER." NO NEGATIVE OUTCOME TO PT DUE TO NOT RECEIVING THE ENTIRE UNIT OF BLOOD, THOUGH THERE WAS BLOOD EXPOSURE TO PT AND HCP'S.
SECTION F COMPLETED BY CO. NO OTHER INFO IS AVAILABLE. EVALUATION: ACTUAL SAMPLES THAT FAILED WERE NOT RETURNED FOR EVALUATION. UNUSED PRODUCT FROM THE IDENTIFIED LOT NUMBER WAS RETURNED. RETURNED 6 UNITS IN SEALED POUCHES AND 1 UNIT IN AN OPEN POUCH. EACH UNIT WAS PRESSURE TESTED AT 4 PSI OF AIR UNDERWATER. NO DEFECTS WERE NOTED.
ANALYSIS REVEALED UNIT HAD NO TONE DUE TO HYBRID FAILURE.
THE CNA WAS PUSHING THE PT INTO THE SHOWER ROOM INTO THE SHOWER CHAIR. THE CHAIR ROLLED OVER THE DOOR ENTRY MAT AND THE CHAIR LEG SPLIT CAUSING THE PT TO FALL FORWARD. THE CNA INJURED HER BACK WHILE ATTEMPTING TO CUSHION THE PT'S FALL. THE PT WAS NOT INJURED.
FDA #1009823. ANTHROS RECEIVED THE REPORT FROM THE FDA -9/13/96 -3:00 PM. THIS IS THE FIRST TIME CO HAD BEEN TOLD OF THIS INCIDENT.
DEVICE WAS SURGICALLY REVISED AFTER AN IMPLANTATION PERIOD OF FOURTY-EIGHT (48) MONTHS. REPORTEDLY, RADIOGRAPHIC EVALUATONS REVEALED A LOOSENED COMPONENT.
H6. ADD'L EVAL. CODES: METHOD, 86 OTHER-(MFG. HISTORY RECORDS REVIEWED) RESULTS, 100 OTHER-(MFG. RECORDS SHOWED NO ABNORMALITIES OR DEVIATIONS FROM PROCESS SPECIFICATIONS) CONCLUSIONS, 68 OTHER(PT. CLINICAL RECORDS NOT RELEASED BY PHYSICIAN DUE TO CONFIDENTIALITY) 68 OTHER-(DEVICE RETAINED BY PT-UNABLE TO FOLLOW-UP) ADD'L MFG. NARRATIVE: THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE PACKAGE INSERT STATES, IN PERTINENT PART, "LOOSENING OF TOTAL HIP COMPONENTS CAN OCCUR. EARLY MECHANICAL LOOSENING MAY RESULT FROM INADEQUATE INITIAL FIXATION, LATENT INFECTION, PREMATURE LOADING OF THE PROSTHESIS OR TRAUMA. LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATIONS OR MECHANICAL PROBLEMS, WITH THE SUBSEQUENT POSSIBILITY OF BONE EROSION AND/OR PAIN." THE PACKAGE INSERT CONTINUES BY STATING, "ADVERSE EFFECTS MAY NECESSITATE REOPERATION, REVISION, ARTHRODESIS OF THE INVOLVED JOINT, GIRDLESTONE AND/OR AMPUTATION OF THE LIMB." OSTEONICS DISCLAIMER: SUBMISSION OF INFO BY OSTEONICS UNDER THE MEDICAL DEVICE REPORTING REGULATION DOSES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFO ACT.
THE PHYSICIAN EXPERIENCED DIFFICULTY IN THE ADVANCEMENT OF A CORONARY STENT WITH DELIVERY SYSTEM TOWARD THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY. DURING THE WITHDRAWAL ATTEMPT, THE STENT EMBOLIZED IN THE TARGET VESSEL. A SNARE WIRE WAS USED TO SUCCESSFULLY RETRIEVE THE STENT FROM THE PT'S BODY. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
DURING THE ATTEMPTED PLACEMENT OF A CORONARY STENT WITH DELIVERY SYSTEM AT THE TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY, THE STENT EMBOLIZED. THE DELIVERY SYSTEM WAS WITHDRAWN FORM THE PT WITHOUT COMPLICATION AND A SNARE WIRE WAS USED TO SUCCESSFULLY RETRIEVE THE EMBOLIZED STENT FROM THE PT'S BODY. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
HEALTHCARE PROFESSIONAL REPORTED THROUGH DEVICE TRACKING FORM THAT THE VALVE WAS EXPLANTED APPROX 44 DAYS POST IMPLANT DUE TO INFECTION. DATE DEVICE EXPIRES: 1/19/2000.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURED. H11. F10 CODES: PT CODE #1930 -LABELED, #2472 -LABELED. DEVICE CODE #2320 -LABELED. H.6. EVALUATION CODES -METHOD CODE 86 -DEVICE HISTORY REVIEWED. RESULTS CODE 100: PACKAGING INSERT CONTAINS ADEQUATE INSTRUCTIONS FOR USE AND WARNINGS FOR POSSIBLE EVENTS. THIS EVENT WAS REPORTED TO CO BY A HOSP DEVICE EXPLANT FORM. NO MEDWATCH FORM WAS RECEIVED BY THE USER FACILITY THEREFORE, CO FILLED FORM 3500A WITH INFO RECEIVED FROM THE MD. "ANY MISSING OR INCOMPLETE DATE ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A." H3 ANALYSIS: AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE MD DID NOT ATTRIBUTE THE EVENT WITH THE PRODUCT, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THIS EVENT. HOWEVER, THE DEVICE HISTORY FOR THIS VALVE WAS REVIEWED AND INDICATED THAT THE VALVE MET ALL FUNCTIONAL AND DIMENSIONAL REQUIREMENTS AND STERILIZATION FOR A SIZE 23MM AORTIC VALVE WHEN RELEASED FOR CLINICAL USE IN 1/95.
CODE 86: EVALUATION OF THE EVENT BASED ON HISTORY OF DEVICE RELATED TO CONTENT OF EVENT DESCRIPTION AND KNOWN QUALITY OF PRODUCT. EVENT DESCRIPTION: THIS EVENT WAS REPORTED TO DATASCOPE AS A CUSTOMER COMPLAINT. THE COMPLAINANT HAS BEEN CERTIFIED TO USE PRODUCT; HOWEVER, CO DOES NOT KNOW IF HE WAS THE USER IN THIS EVENT. ON 2/6/96, PRODUCT WAS USED FOLLOWING DIAGNOSTIC CATHETERIZATION, WITHOUT APPARENT COMPLICATON. AT THE 2 WK FOLLOW-UP, PT HAD NO COMPLAINTS. ON 6/20/96, PT COMPLAINED OF A KNOT IN THE PRODUCT GROIN. ON 7/19/96, THE SHEATH WAS DISCOVERED EMBEDDED IN THE TISSUE TRACT. IT WAS SURGICALLY REMOVED, THE PT RETURNED HOME THE SAME DAY WITH NO FURTHER COMPLICATIONS. CODE 200: SINCE ALMOST 5 MONTHS PASSED, LITTLE IS KNOWN OF PROCEDURE. THE SHEATH IS DESIGNED AND QC TESTED TO DELIVER COLLAGEN THROUGH AN UNRESTRICTED SHEATH. CO'S EXPERIENCE WITH THE DEVICE HAS SHOWN THAT A SHEATH/HUB SEPARATION CAN OCCUR IF THE PATH OF COLLAGEN THROUGH THE SHEATH IS IMPEDED AND THE USER CONTINUED TO ATTEMPT DELIVERY OF THE COLLAGEN. SINCE THE PRODUCT WAS NOT RETURNED AND THE DETAILS OF THE PROCEDURE ARE UNKNOWN, CO CAN ONLY ASSUME THAT DURING THE PROCEDURE EITHER THE SHEATH WAS DAMAGED, POSSIBLY BY FORCING IT THROUGH SCAR TISSUE, OR OCCLUSIVE PRESSURE WAS HELD TOO CLOSE TO THE INSERTION SITE, COMPRESSING THE END OF THE SHEATH. THIS WOULD HAVE IMPEDED THE PATH OF COLLAGEN, CAUSING THE SHEATH TO SEPARATE AS DESCRIBED ABOVE.
DURING THE ATTEMPTED PLACEMENT OF A CORONARY STENT WITH DELIVERY SYSTEM AT THE TARGET LESION SITE IN THE PT'S CORONARY ARTERY, THE STENT EMBOLIZED AND MIGRATED DISTALLY IN THE VESSEL. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION AND ANOTHER BALLOON CATHETER WAS ADVANCED INSIDE THE EMBOLIZED STENT, INFLATED AND WITHDRAWN FROM THE PT'S BODY. A SECOND GUIDEWIRE WAS ADVANCED ALONG SIDE OF THE EXISTING GUIDEWIRE. ANOTHER BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT DISTAL TO THE INTENDED TARGET LESION SITE. TWO ADD'L STENTS WERE SUCCESSFULLY PLACED AT THE TARGET LESION SITE. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE RESULTS OF THE PRODUCT EVAL CANNOT CONFIRM THE COMPLAINANT'S REPORT. THE DEVICE WAS RETURNED FOR EVAL WITHOUT THE STENT; THEREFORE, THE CRIMP OF THE ORIGINAL STENT COULD NOT BE EVALUATED. NO ABNORMALITIES WERE NOTED ON THE DEVICE DURING THE EVAL.
AN 81 YR OLD MALE WITNESSED CARDIAC ARREST. AED UNIT WOULD NOT ALLOW PT'S CARDIAC RHYTHM TO BE ANALYZED TO DETERMINE IT A SHOCKABLE RHYTHM WAS PRESENT. UNIT DISPLAY SHOWED "MONITORING ONLY".
DURING REPAIR OF THE ANTERIOR CRUCIATE LIGAMENTS, THE SUTURE NEEDLE BROKE AT THE TIP AS THE SUTURE WAS USED TO CLOSE THE FASCIA. THE BROKEN NEEDLE TIP COULD NOT BE FOUND. THE SURGEON WENT AHEAD TO CLOSE THE WOUND AND COMPLETE THE PROCEDURE. THE PT IS DOING WELL. DATE DEVICE EXPIRES: 5/2000.
INVESTIGATION IS IN PROGRESS. REF MFR. COMPLAINT #Z96-289. 510K=K900198. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT 1 OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO THE DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
IN 11/94, ONE MONTH AFTER STARTING TO WEAR LATEX GLOVES, THE RPTR, A 40-YR-OLD FEMALE, DEVELOPED SEVERE EXZEMA WITH BLEEDING AND CRACKING OF HER HANDS. ON 11/22/95, SHE WAS DIAGNOSED AS HAVING A LATEX ALLERGY. THE SYMPTOMS SHE EXPERIENCED IMMEDIATELY AFTER BEING EXPOSED TO LATEX INCLUDED: RAPID BREATHING, HOT FLASHES, NAUSEA, DIARRHEA, INCREASED PERSPRIRATION, ITCHING, AND SNEEZING. THE RPTR HAD TO LEAVE HER JOB AS A DENTAL ASSISTANT BECAUSE OF THE LATEX ALLERGY. BECAUSE SHE IS ALSO ALLERGIC TO POLLEN AND MOLD, THE RPTR PURCHASED THE HEPA MASK TO WEAR WHEN SHE WORKED IN HER YARD. ONE AFTERNOON, WHEN SHE PUT THE MASK ON, IMMEDIATELY HER HANDS STARTED ITCHING. SHE THOUGHT THAT PERHAPS IT WAS FROM TOUCHING SOMETHING IN THE YARD. SHE WORE THE MASK FROM 2:00 PM TO 5:00 PM. BY 7:00 PM, SHE FELT AS THOUGH SHE WAS GOING TO PASS OUT. SHE IS ALLERGIC TO BANANAS AND MANGOES BUT HAD NOT EATEN ANY. THE NEXT MORNING, SHE FELT AS THOUGH THE BACK OF HER TONGUE WAS PARALYZED. SHE ALSO EXPERIENCED NAUSEA, HOT FLASHES AND HEADACHE. IN THE AFTERNOON, SHE FOUND RUBBER BAFFLES IN THE MASK AND REALIZED THAT THE RUBBER WAS CAUSING HER TO HAVE THE REACTION. SHE CALLED HER PHYSICIAN AND WAS PRESCRIBED PREDNISONE. THE RPTR IS CONCERNED BECAUSE NOWHERE ON THE PACKAGE DOES IT SAY THAT THE MASK CONTAINS ANY LATEX PARTS.
THE METAL TIP OF AN ELECTROHYDRAULIC LITHOTRIPSY PROBE CAME OFF IN A PT'S URETER AS THE PHYSICIAN WAS ATTEMPTING TO BREAK A URETER STONE. THE METAL PART WAS NOT RETRIEVABLE. A SECOND SURGICAL PROCEDURE WAS DONE TO REMOVE THE FOREIGN BODY.
DATA SHOWN IN SECTION 7 WAS FILLED IN BY THIS MFR. EVALUATION SUMMARY -2280.435 EHL PROBE. THE METAL TIP OF THE DEVICE IS MISSING AND THE INSULATION IS FRAYED WHERE THE TIP WAS EXPELLED. PROBE EXHIBITS USUAL EFFECTS OF OVERUSAGE, (I.E., SPLIT TIP., MISSING TIP). USER INADVERTENTLY CONTINUED TO FIRE THE PROBE AFTER ITS USEFUL LIFE WAS REACHED. GENERATOR ROUTINELY SHOWS WHEN PROBE SHOULD BE REPLACED BUT IT DID NOT, ACCORDING TO THE COMPLAINANT. INSPECTION OF GENERATOR FOUND NO CONTRIBUTING PROBLEMS. SITUATION COULD NOT BE DUPLICATED AT THIS MFR'S PLANT.
TUBING PACKAGE WAS LABELED WITH ONE CATALOG NUMBER BUT IT CONTAINED THE TUBING FROM ANOTHER CATALOG NUMBER. WHEN THE PT TRIED TO RUN HER TPN SOLUTION, THE 0.22 MICRON FILTER WOULD NOT ALLOW THE LIPID SOLUTION TO PASS THROUGH THE TUBING. THE TUBING HAD TO BE REPLACED. THE RPTR STATED THAT THE PT MAY HAVE HAD A TUBING SET WITH AN 0.22 MICRON FILTER ON HAND FROM PREVIOUS USE.
THE DEVICE WAS REMOVED DUE TO A "FLUID LOSS". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 3-PIECE INFLATABLE PROSTHESIS.
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED IN 1988 AND REMOVED ION 8/28/96 DUE TO "FLUID LOSS." IN THE RECEIVED INFORMATION THE PHYSICIAN STATED THAT THE DEVICE "WOULD NOT INFLATE" AND THAT  THERE WAS "NO FLUID SEEN IN RESERVOIR." THE PHYSICIAN ALSO STATED THAT A SPECIFIC LEAKAGE SITE WAS NOT NOTED. THE PHYSICIAN FURTHER STATED THAT THE TUBING WAS NOT KINKED OR TWISTED, THAT NOTHING WAS NOTED IN THE POSITIONING OF THE DEVICE THAT WOULD HAVE CAUSED STRESS(S) AND THAT EXCESS TUBING WAS NOT OBSERVED. HOWEVER THE PHYSICIAN DID STATE THAT AN INADEQUATE LENGTH OF TUBING WAS OBSERVED. ADDITIONALLY, THE PHYSICIAN DID STATE THAT THERE WAS NO INFORMATION IN THE PATIENT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS EVENT AND THAT THE DEVICE WAS NOT IN CONTACT WITH SHARP INSTRUMENTATION DURING REMOVAL. QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PRECLUDED FROM COMMENTING ON THE CONDITION OF THE PROSTHESIS. SHOULD THE EXPLANTED DEVICE BECOME AVAILABLE, OR ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES.
ON 8/19/96, ARRIVED ON SCENE TO FIND A MALE AGE 82 APPROX. 175 POUNDS DIAPHORETIC IN CARDIAC ARREST. CREW ATTACHED UNIT. UNIT DISPLAYED V-FIB RHYTHM. CREW ATTEMPTED TO ANALYZE BUT SCREEN NOW READ "MONITOR ONLY". THEY PRESSED ON THE PADS WITH SAME OUTCOME. THE CREW PUT PT INTO AMBULANCE, REMOVED ELECTRODES AND GOT THE SAME RESULTS. THEY TRANSPORTED PT TO HOSP WHERE HE WAS PRONOUNCED. AT STATION, CREW ATTACHED UNIT TO THEIR DEFIB MANIKIN AND IT WOULD NOT COME OUT OF MONITOR MODE. WHEN ASKED IF PT CABLE WAS SEVERLY BENT, CUST SAID IT WAS. USER FACILITY WILL NOT RELEASE DEVICE FOR CO EVAL. THEY WISH TO ARRANGE FOR AN INDEPENDENT EVAL. CO RECEIVED INFO BY PHONE 8/20/96 AND RECEIVED A MEDWATCH FROM THE USER FACILITY ON 9/5/96.
USER FACILITY WILL NOT RELEASE DEVICE FOR CO EVAL. THEY WISH TO ARRANGE FOR AN INDEPENDANT EVAL. CO RECEIVED INFO BY PHONE 8/20/96 AND RECEIVED MEDWATCH FROM THE USER FACILITY ON 9/5/96.
A 23.5 POSTERIOR CHAMNBER INTRAOCULAR LENS WAS IMPLANTED IN A FEMALE PT ON 7/9/91. ON 8/7/96, THE LENS WAS REMOVED AND A 15.0 DIOPTER INTRAOCULAR  LENS WAS IMPLANTED IN ITS PLACE.
QUALITY ASSURANCE EVALUATION FOUND THAT THE DEVICE WAS CORRECTLY LABELLED AS A 23.5 DIOPTER INTRAOCULAR LENS.
THE DEVICE WAS REMOVED DUE TO A "NON-FUNCTION". THE RESERVOIR AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
IN THE RETURNED QUESTIONNAIRE, THE PHYSICIAN INDICATED THE FOLLOWING: AT IMPLANT A HOLE IN THE RESERVOIR WAS OBSERVED; THERE WAS NO APPARENT INFO IN THE PT'S HISTORY WHICH MAY HAVE CONTRIBUTED TO THIS OCCURRENCE; THERE WAS NO DIFFICULTY EXPERIENCED DURING IMPLANTATION; THE PT DID NOT REPORT DIFFICULTY NOT APPARENTLY DAMAGED DURING THE EXPLANT PROCEDURE. THE RESERVOIR AND A CONNECTOR WITH ATTACHED RESERVOIR TUBING WERE RECEIVED AND EVALUATED BY THE MFR. FUNCTIONAL TESTING OF THE RECEIVED COMPONENTS REVEALED NO ANOMALIES. BASED ON QA'S EXAMINATION, NO FUNCTIONAL ABNORMALITIES WITH THIS COMPONENT WERE DETECTED. THUS, QA IS PRECLUDED FROM CONFIRMING THE REPORTED "RESERVOIR MALFUNCTION."
IMPLANTED ON 11/7/95. COMPONENTS WERE REVISED ON 4/29/96. LINER WAS FOUND TO BE DISENGAGED FROM THE SHELL COMPONENT.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. A FAX WAS SENT ON 9/5/96, TO THE USER FACILITY. CO DID NOT RECEIVE A MEDWATCH REPORT FROM THE USER FACILITY. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT.
IMPLANT FAILED. EXACT DATE OF OCCURRENCE UNKNOWN.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
METHOD - DEVICE NOT RETURNED FOR EVALUATION. CONCLUSIONS-CO CAUTIONS IN LABELING, "IF RESISTANCE IS ENCOUNTERED DURING WIRE GUIDE INSERTION, DO NOT FORCE WIRE GUIDE. WITHDRAWAL OF WIRE GUIDE THROUGH NEEDLE SHOULD BE AVOIDED; BREAKAGE MAY RESULT."
PT MARCHED CONSTRAINED LEFT TOTAL ELBOW WAS IMPLANTED ON 9/15/95, ELBOW DISLOCATED AND BEARINGS WERE REPLACED ON 9/21/95.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. THE SUBJECT PT HAS FILED A PRODUCT LIABILITY LAWSUIT AGAINST CO AND BECAUSE THE MATTER IS CURRENTLY IN LITIGATION, THE FACTS SURROUNDING THIS EVENT ARE NOT FULLY DEVELOPED. THE CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
THE RETURNED IMPLANTS WERE EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANTS ARE NOT BELIEVED TO BE THE CAUSE OF FAILURE.
IMPLANTED ON 11/9/94. REVISED ON 8/1/96, DUE TO FRACTURE.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. A FAX WAS SENT ON 8/23/96, TO USER FACILITY. A VOLUNTARY MEDWATCH FORM WAS FAXED TO CO ON 8/23/96. THE USER FACILITY STATES THAT THE CAUSE OF THE EVENT WAS FROM A POSSIBLE DEFECT. CO FEELS THAT THE CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT.
IMPLANTS FAILED. DATE OF OCCURRENCE UNKNOWN.
THE RETURNED IMPLANTS WERE EVALUATED AND MEET SPECS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANTS ARE NOT BELIEVED TO BE THE CAUSE OF FAILURE.
STAFF MEMBERS WERE MONITORING A PT (AGE AND GENDER UNK) AND THE UNIT'S MONITOR SCREEN WENT BLANK. THE STAFF OBTAINED ANOTHER PD1200 (SERIAL NUMBER UNK) AND CONTINUED MONITORING THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT. THE COMPLAINANT INDICATED THAT THE UNITS ARE ALWAYS PLUGGED INTO AC POWER.
MEDICS WERE MONITORING A "NON-CRITICAL" PT DURING A TRANSPORT. AFTER APPROX 2-3 MINS, THE MONITOR SCREEN DISPLAY BECAME DIM AND THEN DISAPPEARED. THE MEDICS WERE ABLE TO MONITOR THE PT BY PRINTING ECG STRIPS. THERE WAS NO ADVERSE EFFECT ON THE PT.
THE DEVICE WAS REMOVED DUE TO A "BROKEN PUMP". THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
REQUESTS FOR THE EXPLANTED PROTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES.
F1: USER FACILITY. F3: HOSP. F9: 7 YRS. F10: PT CODE: 1806. DEVICE CODE: 2204. F12: HOSP. F13: NO. F14: REFER TO D3.
DURING ATTEMPT TO PLACE A CENTRAL VENOUS CATHETER INTO PT'S RIGHT GROIN, RESISTANCE WAS NOTED. THE .018 X 65 CM GUIDE WIRE WAS PULLED BACK THROUGH THE INSERTION NEEDLE. THE GUIDE WIRE SHEARED AND UNCOILED PARTIALLY. FORCEPS WERE USED TO RETRIEVE THE WIRE FROM THE VESSEL.
STAFF MEMBERS WERE PREPARING THE UNIT FOR AN IN-HOUSE TRANSPORT AND THE UNIT FAILED TO POWER UP. THE STAFF OBTAINED ANOTHER UNIT (MANUFACTURER UNK) AND TRANSPORTED THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT.
THE DEVICE WAS REMOVED DUE TO "INFECTION". THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED AS OF THE DATE OF THIS REPORT.
IN THE RECEIVED INFO THE PHYSICIAN STATED THAT THERE WERE NO APPARENT CIRCUMSTANCES IN THE PT'S HISTORY THAT WOULD HAVE CONRIBUTED TO THIS OCCURRENCE AND THAT THE DEVICE WAS NOT REPLACED. THE PHYSICIAN FURTHER STATED THAT THE CULTURE RESULTS WERE NEGATIVE. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION. QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE INFECTION REPORT. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASES. BASED ON THIS KNOWLEDGE, QA CONCLUDED THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
OVER THE COURSE OF A WEEK, STAFF MEMBERS WERE MONITORING SEVERAL DIFFERENT PTS AND THE UNIT LOST POWER WITHOUT DISPLAYING ANY ERROR MESSAGES. WHEN THE ALLEGED MALFUNCTION OCCURRED, THE STAFF WOULD CHANGE THE BATTERY, TURN THE UNIT OFF AND THEN ON AGAIN AND THE UNIT WOULD FUNCTION PROPERLY. THERE WAS NO ADVERSE EFFECT ON ANY OF THE PTS.
IMPLANTS FAILED. DATE OF OCCURRENCE IS UNKNOWN.
THE RETURNED IMPLANTS WERE EVALUATED AND FOUND TO MEET SPECS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANTS ARE NOT BELIEVED TO BE THE CAUSE OF FAILURE.
THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION". THERE "MAY HAVE ALSO BEEN INFECTION". THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 5/10/96 AND REVISED ON 7/19/96 DUE TO A "MALFUNCTION" AND POSSIBLE INFECTION. REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED AN AREA OF SEVERAL SEPARATIONS/LEAKAGE SITES, IN A LINEAR PATTERN, AROUND THE RESERVOIR'S INLET TUBE. THE TUBING DISPLAYS IMPRESSION MARKINGS ON THE SURFACE, AND EXAMINATION OF THE SURFACES OF THE SEPARATIONS, REVEALED MARKINGS INDICATING  CONTACT WITH UNSHOD INSTRUMENTATION I.E. HEMOSTAT. NO OTHER FUNCTIONAL ABNORMALITIES WERE OBSERVED. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT THE OBSERVED DAMAGE OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. BECAUSE THE INFO PROVIDED DOES NOT INDICATE WHAT FACTOR(S) CONTRIBUTED TO THE REPORTED EVENT, AND BECAUSE OF THE BRIEF IN-VIVO DURATION PRIOR TO THIS OCCURRENCE, QA IS PRECLUDED FROM DETERMINING THE SEQUENCE OF EVENT'S RESULTING IN THE OBSERVED DAMAGE TO THE RESERVOIRS INLET TUBE AND PRECLUDED FROM DETERMINING IF THIS DAMAGE CONTRIBUTED TO THE REPORTED "MALFUNCTION." BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH. THE REVIEW OF THE DEVICE LOT HISTORY RECORDES BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEIVCE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT ANY INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE.
ADD'L INFO WAS REQUESTED, CONCERNING THE NATURE OF THE MALFUNCTION REPORT, HOWEVER NO RESPONSE HAS BEEN RECEIVED. THE ENTIRE DEVICE WAS RECEIVED AND EVALUATED BY THE MFR. THE DEVICE PASSED ALL FUNCTIONAL TESTS. BASED ON QA'S EXAMINATION AND TESTING. QA CONCLUDES THAT NO FUNCTIONAL ABNORMALITIES OF THE DEVICE. QA IS PRECLUDED FROM DETERMINING THE REASON THE DEVICE WAS REMOVED.
A 68 YR OLD MALE PT WENT INTO CARDIAC ARREST WHILE RECEIVING DENTAL WORK. THE MEDICS ARRIVED TO FIND THE DENTIST PERFORMING CPR ON THE PT. THE MEDICS DEFIBRILLATED THE PT THREE TIMES. THE UNIT PRINTED STRIPS FOR EACH DEFIBRILLATION ATTEMPTED, BUT THE MEDICS INDICATED THAT THE PT'S BODY DID NOT REACT. THE MEDICS DEFIBRILLATED THE PT THREE MORE TIMES AND AN "OPEN AIR DISCHARGE" MESSAGE APPEARED ON THE UNIT'S MONITOR SCREEN. THEY ATTEMPTED TO DEFIBRILLATE THE PT THREE MORE TIMES BUT THE ERROR MESSAGE REMAINED ON THE SCREEN. THE MEDICS ARRIVED AT THE FACILITY'S ER AND THE PT WAS DEFIBRILLATED TWICE AND HIS RHYTHM WAS CONVERTED. THERE WAS NO ADVERSE EFFECT ON THE PT.
THE DEVICE WAS REMOVED DUE TO "AUTOINFLATION". THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED.
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS REVISED ON 8/12/96 DUE TO "AUTOINFLATION." NO IMPLANT INFORMATION WAS PROVIDED. REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADDITIONAL INFORMATION SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFORMATION HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT REQUESTED INFORMATION, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES.
STAFF MEMBERS NOTICED THAT THE UNIT'S CHARGE LIGHT WAS NOT ON AND THAT THE UNIT WAS BROUGHT TO THE FACILITY'S BIOMEDICAL ENGINEERING DEPT. IT IS UNCLEAR IF THE UNIT WAS USED ON A PT OR NOT. HOWEVER, AT THIS POINT IN TIME THERE IS NO INDICATION OF ANY ADVERSE PT EFFECT.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM CO'S OFFICE.
MEDICS WERE MONITORING A PT (AGE AND GENDER UNK) AND A GREEN DOT APPEARED IN THE CENTER OF THE UNIT'S MONITORING SCREEN ALONG WITH A "STATUS 42" MESSAGE. THEN, THE UNIT'S MONITOR WENT BLANK. THE MEDICS TURNED THE UNIT OFF AND THEN ON AGAIN. THEY BEGAN TO MONITOR THE PT AGAIN, BUT THE SAME ALLEGED MALFUNCTION OCCURRED AGAIN. THE MEDICS OBTAINED ANOTHER UNIT (MANUFACTURER UNK) AND TRANSPORTED THE PT. THERE  WAS NO ADVERSE EFFECT ON THE PT.
THE DEVICE WAS ORIGINALLY IMPLANTED ON 7/17/96. "ONE WEEK OUT FROM IMPLANT, PT HAD A REVISION FOR HEMATOMA. NO PARTS WERE CHANGED, ONLY MOVED PUMP TO NEW LOCATION AND EVACUATED THE HEMATOMA". (NO SPECIFIC DATE OF THIS EVENT WAS PROVIDED). ADDITIONALLY, ON 8/20/96 THE ENTIRE DEVICE WAS/REMOVED DUE TO "SUSPECTED INFECTION, EDEMA, DRAINAGE AND FEVER".
IN THE RECEIVED INFO THE PHYSICIAN STATED THAT THE PT "DEVELOPED SEVERE PAIN AND SCROTAL EDEMA THEN UNDERWENT REVISION WITH REMOVAL OF A SCROTAL HEMATOMA FOR DRAINAGE." AT THIS TIME THE PUMP WAS ALSO REPOSITIONED. THE PT PRESENTED WITH PAIN AND SWELLING AGAIN, AND THE PHYSICIAN STATED THAT THE PT WAS "DEVELOPING INFECTION AROUND THE MOVED PUMP." THE PHYSICIAN NOTED "MILD PENILE EDEMA, REDNESS, AND LOSS OF SCROTAL RUGAE, SWELLING AROUND THE PUMP AND NO DRAINAGE." BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE INFECTION REPORT. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
DR MAILED IN BROKEN ABUTMENT WITHOUT INFO OTHER THAN PT NAME. DR WOULD NOT RETURN CALLS REQUESTING INFO. PT IS SAME PT AS PRIOR MDR REPORT #M728783.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO WAS UNABLE TO REVIEW THE PRODUCT'S LOT HISTORY SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE OFFICE.
DR REMOVED THE REMAINING APICAL END OF AN IMPLANT. PT IS SAME PT AS PRIOR MDR REPORT #M747509.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS COULD NOT BE TAKEN DUE TO THE DAMAGED CONDITION OF THE PRODUCT. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DOCTOR'S OFFICE.
STAFF MEMBERS WERE ATTEMPTING TO RESUSCITATE A FEMALE PT (AGE UNK). THE STAFF CHARGED THE UNIT AND ATTEMPTED TO DISCHARGE THE UNIT USING THE PADDLES. TE UNIT DID NOT DISCHARGE. THE STAFF OBTAINED ANOTHER UNIT (MANUFACTURER UNK) AND CONTINUED TO TREAT THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT. THE COMPLAINANT ALSO INDICATED THAT THE STAFF CHECKED THE UNIT ON THE MORNING OF THE ALLEGED MALFUNCTION AND THE UNIT FUNCTIONED PROPERLY.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER FROM THE OFFICE WAS UNAVAILABLE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DOCTOR'S OFFICE.
MEDICS ARRIVED AT A PT'S HOUSE. THEY CARRIED THE UNIT THROUGH A "DOWNPOOR" FROM THE AMBULANCE TO THE PT'S FRONT DOOR. THE MEDICS BEGAN TREATING THE PT (AGE AND GENDER UNK) AND THE UNIT FUNCTIONED PROPERLY. AS THE CALL PROGRESSED, THE UNIT'S MONITOR SCREEN BECAME DISTORTED. THE SCREEN DISTORTION INCREASED AND EVENTUALLY THERE WAS ONLY A DOT IN THE CENTER OF A BLANK SCREEN. THERE WAS NO ADVERSE EFFECT ON THE PT.
THE DEVICE WAS BEING UTILIZED ON A PT FOR GASTROSTOMY FEEDING. SOMETIME FOLLOWING PLACEMENT, THE BALLOON DEFLATED AND THE CATHETER MIGRATED. THE PT REC'D SOME FEEDING INTO THE PERITONEAL CAVITY. AS OF 8/22 THE PT'S CONDITION WAS STABLE.
PT PRESENTED 9/1/95 WITH PINCHING, SHARP FEELING, FACIAL PAIN, X-RAYS WITHIN NORMAL LIMITS. PT STILL EXPERIENCED FACIAL PAIN, DEMANDED DR REMOVE IMPLANTS.
STAFF MEMBERS WERE MONITORING A PT (AGE AND GENDER UNK) AND THE UNIT'S MONITOR SCREEN WAS UNABLE TO DETECT THE PT'S ECG TRACE. THERE IS NO INDICATION OF ANY ADVERSE EFFECT ON THE PT.
THE DEVICE WAS REMOVED DUE TO A "FAILURE TO INFLATE". "THE PUMP WAS DECOMPRESSED WITHOUT INFLATION". THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
IN THE RECEIVED INFO THE PHYSICIAN NOTED THAT THE PROBLEM WAS OBSERVED IN 3/96 AND THE "PUMP DECOMPRESSED WITHOUT INFLATION." THE PHYSICIAN ALSO STATED THAT "BOTH LEADS TO THE PUMP AVULSED." EXAMINATION AND TESTING OF THE DEVICE REVEALED TWO SEPARATED/LEAKAGE SITES, CONFIRMING THE PHYSICIAN'S OBSERVATIONS. THE FIRST IS A COMPLETE SEPARATION OF OUTLET #1'S EXITING TUBING, AT THE STRAIN RELIEF/TUBE JUNCTION. EXAMINATION OF BOTH SURFACES OF THE SEPARATION, ON THE OUTLET AND THE SEPARATED TUBING PORTION, REVEALED MARKINGS CHARACTERISTIC OF STRESS(S) INDUCED RENDING. AN AREA OF ABRASION IS NOTED POSTERIORLY OF THE TUBE AND STRAIN RELIEF. THE SECOND IS A PARTIAL SEPARATION OF OUTLET #2'S EXITING TUBING, ANTERIORLY LOCATED AND EXTENDING AROUND TO THE POSTERIOR, AT THE STRAIN RELIEF/TUBE JUNCTION. EXAMINATION OF THE SURFACES OF THE SEPARATION REVEALED MARKINGS CHARACTERISTIC OF STRESS(S) INDUCED RENDING. AN AREA OF ABRASION IS NOTED ANTERIORLY ON THE EXITING TUBE, PROXIMAL TO THE STRAIN RELIEF. POSTERIORLY AN AREA OF ABRASION IS NOTED SURROUNDING THE SEPARATION AT THE STRAIN RELIEF/TUBE JUNCTION. ADJACENT TO THIS AREA OF ABRASION TWO CREASE MARKS ARE NOTED. OTHER AREAS OF ABRASION ARE NOTED POSTERIORLY ALONG THE SURFACES OF THE INLET TUBE PROXIMAL TO OUTLET #2, AND POSTERIORLY ON THE STRAIN RELIEF AND EXITING TUBE OF THE INLET. WITHIN THIS AREA OF ABRASION LOCATED POSTERIORLY AT THE STRAIN RELIEF/TUBE JUNCTION OF THE INLET, A CREASE MARK IS NOTED. RECREATION OF THE TUBINGS POSITIONING BASED ON THE PATTERN OF ABRASION INDICATES THAT THE TUBES WERE OVERLAPPED WHILE IN-VIVO. BASED ON QA'S EXAMINATION AND THE PHYSICIAN'S OBSERVATIONS, QA CONCLUDED THAT WHILE IN-VIVO THE TWO OUTLETS AND THE INLET TUBES WERE OVERLAPPED AND ABRADING AGAINST ONE ANOTHER. IN ADDITION, OUTLET #1'S EXITING TUBE AND THE INLET TUBE WERE PARTIALLY KINKED AND ABRADING AGAINST THEMSELVES AND THEIR ASSOCIATED STRAIN RELIEFS. QA FURTHER CONCLUDED THAT THIS POSITIONING, CONBINED WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STERSS(S) TO REND THE TUBING AT THE NOTED LEAKAGE SITES. THESE RENTS WOULD HAVE ALLOWED THE LOSS OF FLUID AND RENDERED THE DEVICE INOPERABLE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAT WHAT IS STATED IN THE LABELING  OR USUAL FOR SERVICE.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-00069.
ON 9/11/96 A 66 YR OLD PT UNDERWENT A VAPORTRODE PROCEDURE WHICH RESULTED IN A "BLADDER PERFORATION". THE PHYSICIAN WAS USING AN ELECTRODE MANUFACTURED BY ANOTHER CO. THE PHYSICIAN STATED HE HEARD A "POP" AND THE BLADDER RUTPURED. SURGICAL REPAIR OF THE BLADDER WAS NECESSARY.
THE GENERATOR WAS NOT RETURNED TO CO AS IT HAD JUST UNDERWENT PERIODIC MAINTENANCE TESTING AT THE HOSP AND WAS OPERATING PROPERLY. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF CO THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY.
THIS IS FIRST OCCURRENCE, DR DID NOT HAVE MUCH INFO TO GIVE OTHER THAN ABUTMENT BROKE IN FUNCTION. PT IS SAME PT AS MEDWATCH REPORT 2023141-1996-00068.
THE CORONAL RIM OF AN IMPLANT SHEARED DUE TO BRUXING. PT IS REPORTEDLY FINE.
A 10/11MM TROCAR WAS PLACED IN THE ABDOMEN. THE SURGEON NOTICED A LOOSE SCREW ON THE GRIPPER PORTION OF THE LOWER RIGHT TROCAR. THE SURGEON ADJUSTED THE SCREW TO KEEP THE TROCAR IN POSITION. UPON INSPECTION BLEEDING WAS OBSERVED. THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING SEVERAL TIMES BY SUTURE. HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL. THE TROCAR WAS REMOVED AND A LAPAROTOMY WAS PERFORMED. THE SURGEON VISUALIZED A RAGGED MUSCLE WITH EVIDENCE OF RIGHT EPIGASTILE INJURY LIGATION. THE MUSCLE EDGES WERE CAUTERIZED AND HEMOSTATIS NOTED.
THE SYSTEM WAS IMPLANTED TWO YEARS AGO. IT WAS FOUND IN JULY, 1996 THAT THE PERITONEAL CATHETER HAD A FISSURE AT THE SITE OF THE CERVIX. THE PT WAS OFTEN EXERCISING AT A GOLF DRIVING RANGE. HE DID NOT REALIZE THAT THE CATHETER WAS BROKEN.
THE PERITONEAL CATHETER OF THE RETURNED PORDUCT FRACTURED 1.5 CM FROM THE PROXIMAL END OF THE CATHETER. THE FRACTURED ENDS OF THE CATHETER APPEARED TO HAVE BEEN PARTIALLY WORN AWAY MOST PROBABLY DUE TO ABRASION. THIS THEN PROBABLY LED TO THE REMAINDER OF THE CATHETER OF THE CATHETER WALL TREARING CAUSING THE BREAK. WHICH WAS ALSO MOST LIKELY CAUSED BY ABRASION. THE TUBING MET CO'S SPECIFICATIONS FOR DIMENSIONS, TENSILE STRENGTH, AND ULTIMALTE ELONGATION.
TWO WEEKS AFTER ONE LEVEL FUSION AT C5-6, PT PRESENTED TO SURGEON WITH INCREASED SYMPTOMS. X-RAYS REVEAL THAT THE BONE GRAFT HAD COLLAPSED AND THE PLATE HAD SHIFTED INFERIORLY. REVISION SURGERY CONFIRMED PREOPERATIVE ASSESSMENT. IN ADDITION, IT WAS NOTED THAT ONE OF THE FOUR LOCKING CAPS HAD DISASSOCIATED FROM THE THREADED POST.
F1: USER FACILITY. F3: HOSP. F9: 3 MONTHS. F10: PT CODE: 1964. DEVICE CODE: 2204. F12: HOSP. F13: NO. F14: REFERE TO D3.
IMPLANTED ON 12/19/95. REVISED IN 5/96, DUE TO FRACTURE OF CABLE PLATE.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. A FAX WAS SENT ON 9/17/96 TO THE USER FACILITY. CO DID NOT RECEIVE A MEDWATCH REPORT FROM THE USER FACILITY. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT.
IMPLANTED AT AN UNK DATE. REVISED WITH TWO PLATES ON 8/13/96, DUE TO FRACTURE OF CABLE PLATE.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. A FAX WAS SENT ON 9/16/96, TO THE USER FACILITY. CO DID NOT RECEIVE A MEDWATCH FORM FROM THE USER FACILITY. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT.
DEVICE WAS BEING UTILIZED ON A FEMALE PT DURING A PERCUTANEOUS BILIARY DRAINAGE PROCEDURE. THE CATHETER WAS ADVANCED WITH THE WIRE INTO THE DUODENUM TO ACCOMPLISH COMPLETE ACCESS. ONCE THE WIRE WAS IN PLACE, THE CATHETER WAS WITHDRAWN. AT THIS POINT, THE CATHETER TIP SEPARATED AND REMAINED IN THE BILIARY TREE ON THE WIRE. THE PHYSICIAN THEN ADVANCED A BALLOON CATHETER, LODGED THE SEPARATED TIP SEGMENT AND WITHDREW THE BALLOON CATHETER AS WELL AS THE TIP SEGMENT.
AN EXAMINATION OF THE RETURNED USED CATHETER CONFIRMED THAT A PORTION OF THE CATHETER TIP, APPROX 2.5CM IN LENGTH, HAS SEPARATED FROM THE MAIN CATHETER BODY. CO IS UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT. HOWEVER, CO CAN ADVISE THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND ARE CURRENTLY INVESTIGATING THIS MATTER TO ASSURE THAT THIS SITUATION DOES NOT RECUR.
THE DEVICE WAS REMOVED AS "THERE WAS A BREAK IN THE TUBING AT THE LEVEL OF THE PUMP PLATFORM LEADING TO ONE OF THE CYLINDERS". THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
ACCORDING TO THE AVAILABLE INFO THIS DEVICE WAS IMPLANTED ON 5/20/93 AND REVISED ON 11/4/94 DUE TO A "TUBING TEAR." IN THE RECEIVED INFO THE PHYSICIAN STATED THAT THE PROSTHESIS HAD FUNCTIONED WELL UNTIL "ALL FLUID WAS LOST." THE PHYSICIAN NOTED DURING SURGERY "THERE WAS A BREAK IN THE TUBING AT THE LEVEL ON THE PUMP PLATAFORM LEADING TO ONE OF THE CYLINDERS." EXAMINATION AND TESTING OF THE DEVICE REVEALED A PARTIAL SEPARATION OF OUTLET #1'S STRAIN RELIEF, CONFIRMING THE PHYSICIAN'S OBSERVATIONS. EXAMINATION OF THE SURFACES OF THE SEPARATION REVEALED MARKINGS CHARACTERISTICS OF STRESS(S) INDUCED RENDING. OPPOSITE THE SEPARATION, ALONG THE SUPERIOR SURFACE OF THE STRAIN RELIEF, THREE CREASE MARKS ARE NOTED. BASED ON QA'S EXAMINATION AND THE PHYSICIAN'S OBSERVATIONS, QA CONCLUDED THAT WHILE IN-VIVO, OUTLET #1'S STRAIN RELIEF WAS PARTIALLY KINKED. QA FURTHER CONCLUDED THAT THIS POSITIONING, COMBINED WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBING AT THIS SITE. THIS RENT WOULD HAVE ALLOWED THE NOTED FLUID LOSS AND RENDERED THE DEVICE INOPERABLE.
DR WAS PLACING HEALING SCREW AND HE FELT THE IMPLANT ROTATED, HE NOTICED PRESENCE OF PUS. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS COMPLETED AND FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
THE DEVICE WAS REMOVED AS "THE OLD PUMP HAD A BREAK IN THE TUBING AT THE LEVEL OF THE PUMP PLATFORM LEADING TO THE OUTSIDE CYLINDER". THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
ACCORDING TO THE AVAILABLE INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 9/16/91. ON 10/27/96 ONLY THE PUMP COMPONENT WITH AN ATTACHED CONNECTOR WAS REMOVED. THE REC'D OPERATIVE REPORT STATED THAT THE, "PUMP HAD A BREAK IN THE TUBING AT THE LEVEL OF THE PUMP PLATFORM LEADING TO THE OUTSIDE CYLINDER." THE PUMP AND CONNECTOR WERE REC'D AND EVALUATED BY THE MFR. A LEAKAGE SITE WAS OBSERVED AT THE STRAIN RELIEF JUNCTION OF THE SERIALIZED OUTLET. THE LEAKAGE SITE WAS MICROSCOPICALLY EXAMINED. THE INNER AND OUTER LAYER OF TUBING WERE SEPARATED. THE CROSS SECTIONAL SURFACES OF THE SEPARATED TUBING WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. THE TUBING WAS REC'D BENT AWAY FROM THE SEPARATION SITE, INDICATING THAT THIS TUBING WAS POSITIONED IN A STRESSFUL WAY FOR A LONG PERIOD OF TIME. NEAR THE LEAKAGE SITE AN AREA OF ABRASION WAS NOTED. ABRASION WAS ALSO LOCATED ON THE NON-SERIALIZED TUBING. RECREATION OF THE TUBING, BASED ON THE PATTERNS OF ABRASION, INDICATED THAT WHILE IN VIVO THE SERIALIZED AND NON-SERIALIZED TUBING WERE ABRADING. BASED ON THE REC'D INFO AND QA'S EXAMINATION, QA CONCLUDES THAT THE TUBING OF THE SERIALIZED OUTLET TORE. THIS TEAR WAS CAUSED BY THE STRESS(ES) ASSOCIATED WITH THE POSITIONING OF THE TUBING, THE ABRADING TUBING, AND USAGE OF THE DEVICE.
DEVICE WAS PLACED INTO THE PT ON 8/23/96, FOR CHEMOTHERAPY PURPOSES FOR A BONE TUMOR. THE CATHETER WAS PLACED DOWN THE LEFT FEMORAL. ON 8/27/96, THE CATHETER WAS REMOVED. UPON REMOVAL, THE CATHETER TIP SEPARATED. AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED SEGMENT WITH A RETRIEVAL BASKET. HOWEVER, THE TIP SEPARATED INTO TWO SEGMENTS. ONE SEGMENT WENT DOWN THE LEFT PERONEAL. NO FURTHER ATTEMPTS WERE MADE TO REMOVE THE SEGMENTS.
NO PRODUCT WAS REC'D FROM THE CUSTOMER FOR THIS EVALUATION. BASED ON THE INFORMATION PROVIDED, CO IS UNSURE AS TO WHY THE TIP SEPARATED.
IMPLANT REMOVED 1 MONTH AFTER PLACEMENT DUE TO SOFT TISSUE INFECTION. LR AREA SITE #29, BONE QUALITY TYPE II. 3 OTHER FIXTURES PLACED ARE DOING WELL. PT MAY NOT HAVE TAKEN ANTIBIOTICS AT INITIAL SURGERY.
THE RETURNED IMPLANT WAS FOUND TO BE CLEAN AND TO MEET SPECS. THE LIKELY CAUSE OF FAILURE IS THE REPORTED INFECTION.
DEVICE WAS BEING USED TO TRANSPORT SAMPLED FROM A LABORATORY IN A FOREIGN COUNTRY TO THE USA. PACKAGE WAS REFUSED BY AN AIRLINE OFFICIAL; REASON FOR REFUSAL IS NOT KNOWN. THE COURIER REPORTEDLY OPENED THE SHIPPING CARTON WHERE THE SUBJECT DEVICE WAS PACKAGED IN DRY ICE, EXAMINED THE DEVICE, RETURNED IT TO THE SHIPPING CARTON AND THEN THE TOP OF THE DEVICE BURST AND THE COURRIER RECEIVED LACERATIONS ON HIS FACE, EYE, ARM AND TORSO. THE SUBJECT DEVICE WAS PACKAGED WITH MULTIPLE CRYOVIALS WHICH CONTAINED FROZEN SAMPLE OF HUMAN SERUM WITH KNOWN HIV. THE COURRIER WAS IMMEDIATELY ADMINISTERED PROPHYLACTIC TREATMENT. IT IS NOT KNOWN IF THE SUBJECT DEVICE OR THE INNER CONTAINERS CAUSED THE LACERATIONS. IT IS NOT KNOWN IF THERE WAS AN ACTUAL EXPOSURE TO HIV. THE INITIAL REPORTER THEORIZED THAT THE SUBJECT DEVICE WAS MISUSED IN THAT DRY ICE OR LIQUID NITROGEN MUST HAVE BEEN ADDED INSIDE THE SUBJECT DEVICE TO COOL IT. MFR'S LABEL DOES WARN AGAINST USING A DRY ICE INSIDE THE SUBJECT DEVICE.
PLEASE NOTE THAT SECTION F IS NOT APPLICABLE AND HAS NOT BEEN COMPLETED BECAUSE THIS INFO WAS RECEIVED VIA A PHONE CALL FROM SOURCE, WHICH IS NOT A USER FACILITY OR A DISTRIBUTOR. ALSO NOTE THAT THE SERIOUSNESS OF THE LACERATIONS REPORTED IS NOT KNOWN. THIS REPORT IS BEING MADE AT THIS TIME DUE TO THE POTENTIAL HIV EXPOSURE.
THE DEVICE WAS REMOVED DUE TO "A BREAK ON THE INSIDE TUBING AS IT LEFT THE PUMP PLATFORM". THE PUMP AND ASSEMBLY KIT COMPONENT(S), 2 STRAIGHT TRUE-LOCK CONNECTOR(S), ONLY WERE REMOVED AND REPLACED.
THE PUMP WITH AN ATTACHED CONNECTOR WAS RECEIVED AND EVALUATED BY THE MFR. A LEAKAGE SITE WAS DETECTED ON THE NON-SERIALIZED STRAIN RELIEF JUNCTION. A MICROSCOPIC EXAMINATION OF THE LEAKAGE SITE WAS PERFORMED. THE INNER AND OUTER LAYER TUBING WAS SEPARATED. THE CORSS SECTIONAL SURFACES OF THE SEPARATED TUBING WERE ROUGHT AND IRREGULAR, INDICATING A TUBING TEAR. ABRASION WAS LOCATED IN THE FOLLOWING AREAS: THE INFERIOR SURFACE OF THE SERIALIZED OUTLET, THE SUPERIOR AND INFERIOR SURFACES OF THE NON-SERIALIZED OUTLET, AND THE SUPERIOR SURFACE OF THE INLET TUBING. RECREATION OF THE TUBING'S POSITION, BASED ON THE PATTERNS OF ABRASION, INDICATED THAT WHILE IN-VIVO THE NON-SERIALIZED OUTLET TUBING WAS ABRADING AGAINST THE SERIALIZED OUTLET TUBING AND THE INLET TUBING. BASED ON THE RECEIVED INFO AND QUALITY ASSURANCE'S EXAMINATION, QA CONCLUDES THAT THE NON-SERIALIZED TUBING WAS TORN. THIS TEAR WAS CAUSED BY STRESS(ES) ASSOCIATED WITH THE ABRADING TUBING AND THE DEVICE USAGE. THUS, QA CONFIRMS THE REPORTED TUBING WEAR.
IMPLANTS PLACED 5/30/96. IMPLANTS WERE REMOVED BECAUSE THEY WERE NOT INTEGRATED. PT IS A HEAVY SMOKER AND HAS LOST OTHER IMPLANTS (PREVIOUSLY REPORTED).
THE RETURNED IMPLANT WAS EVALUATED AND MEETS SPECS. THE LIKELY CAUSE OF FAILURE IS THE PT'S HEAVY SMOKING, COMPOUNDED BY THE REPORTED INFECTION.
IMPLANT PLACED 5/30/96. IMPLANT REMOVED BECAUSE IT WAS NOT INTEGRATED. SAME PT HAS LOST OTHER IMPLANTS (PREVIOUSLY REPORTED).
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. THE PT'S HEAVY SMOKING, COMPOUNDED BY THE REPORTED INFECTION, IS THE LIKELY CAUSE OF FAILURE.
THE DEVICE WAS REMOVED DUE TO "INFECTION". THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED UNTIL 8/27/95 WHEN THE PT WAS REIMPLANTED AFTER A DURATION OF HEALING, WITH ANOTHER 3-PIECE INFLATABLE PROSTHESIS.
REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL REEVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE INFECTION REPORT. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
SIX IMPLANTS WERE PLACED 6/28/96. 1 IMPLANT (SITE # 8) WAS REMOVED, PT NOTED MORE DISCOMFORT IN THAT AREA. PT WAS A SMOKER.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECS. THE LIKELY CAUSE OF FAILURE IS THE PT'S SMOKING.
DURING THE MULTIPLE ATTEMPTS AT SYNCHRONIZED CARDIOVERSION, THE DEFIBRILLATOR FAILED TO DISCHARGE AT THE APPROPRIATE TIME AND DELIVER THE CURRENT NECESSARY TO CONVERT THE TACHYCARDIA RHYTHM. A SECOND AND LATER A THIRD DEFIBRILLATOR (SAME MODEL) WERE IMMEDIATELY RUSHED TO THE EMERGENCY RESPONSE TEAM; HOWEVER, BOTH THE SECOND AND THIRD DEFIBRILLATORS ALSO FAILED TO DISCHARGE AT THE APPROPRIATE TIME AND DELIVER THE PROPER CURRENT TO THE PT".
CO'S INVESTIGATION INDICATES THAT THE SPECIFIC DEVICES ALLEGEDLY INVOLVED IN THIS INCIDENT CANNOT BE PRECISELY IDENTIFIED BY THE HOSP. ACCORDING TO A HOSP SOURCE, THE 'FIRST' AND 'SECOND' DEFIBS WERE HOOKED UP (POSSIBLY WITH OTHER EQUIPMENT) INCORRECTLY. WHEN THE 'THIRD' DEFIB WAS BROUGHT IN, THEY DISCOVERED AND CORRECTED THE HOOK UP AND THE THIRD DEFIB WORKED AS EXPECTED. THE HOSP INDICATED THAT THE EQUIPMENT WAS BEING OPERATED BY HEALTH PROFESSIONALS WHO HAD BEEN TRAINED IN ITS USE. THE SPECIFIC DEVICES WERE NOT IDENTIFIED BY USERS AT THE TIME OF THE EVENT, ALTHOUGH THE HOSP BELIEVES THAT THESE UNITS WERE INVOLVED: M1722B S/N 3525A16839. M1722B S/N 3525A16731. M1722B S/N 3525A16683. SINCE THIS IDENTIFICATION IS UNCERTAIN AND SINCE CO'S INVESTIGATION INDICATES THAT THAT AT LEAST ONE OF THE THREE DEVICES WAS NOT A FACTOR IN THE DEATH, CO IS FILING A SINGLE REPORT. THE HOSP REPORTED THAT SUBSEQUENT TO THE EVENT THESE DEFIBS WERE THOROUGHLY TESTED BY THE HOSPITAL'S BIO MED DEPT. THE HOSP REPORTED THAT NO TROUBLE WAS FOUND; EACH DEFIB PASSED ALL PERFORMANCE TESTS. THE DEFIBS HAVE REMAINED IN SVC SINCE THE INCIDENT. CO WAS UNABLE TO OBTAIN LOG STRIPS FROM THE TIME OF THE INCIDENT.
THE PT WAS SCHEDULED FOR A LEAD REVISION ON 9/12/96 DUE TO PACING LEAD IMPEDANCE PROBLEMS WITH THE PACING LEAD WHICH HAD BEEN IMPLANTED ON 7/22/92. THE PACING LEAD IMPEDANCE VARIED BETWEEN 900 OHMS AND 1300 OHMS. THE LEAD WAS CAPPED AND LEFT IN THE PT. AN ATTEMPT WAS MADE TO IMPLANT A NEW LEAD. THE NEW LEAD WHEN CONNECTED TO THE V-115 DEFIBRILLATOR GAVE IMPEDANCE VALUES OF LESS THAN 100 OHMS AND A FLATLINE ON THE REAL-TIME ELECTROGRAMS. REPROGRAMMING OF THE V-115 DID NOT ELIMINATE THE IMPEDANCE PROBLEM. THE PHYSICIAN EXPLANTED THE RV1101 AND THE V-115.
INFO FOR SECTION F CANNOT BE OBTAINED OR VERIFIED WITH THE USER FACILITY GIVEN THE 5-DAY REPORTING DEADLINE. F10 CODE #2202 - NOT LABELED, CODE #2409 - NOT LABELED. H 3 EVALUATION SUMMARY. AN EVALUATION OF THE V-115 SHOWS THAT THE CONNECTOR BLOCKS IN THE DEVICE HEADER ARE OUT OF SPEC. AS A PERCAUTIONARY MEASURE, CO HAS ELECTED TO INITIATE A REMEDIAL ACTION FOR THE DEFIBRILLATOR.
THE DEVICE WAS REMOVED DUE TO AN "INFECTION".
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 5/31/96 AND REVISED ON 7/9/96 DUE TO AND "INFECTION," CULTURES REVEALED THE PRESENCE OF STAPH EPIDERMIDIS ORGANISMS. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFORMATION HAS BEEN RECEIVED. WITHOUT THE REQUESTED INFORMATION, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. HOWEVER, BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH, AS THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STARILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STARILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE.
THE PT AND CHAIR UNIT BECAME DETACHED FROM THE HOIST CAUSING THE PT TO FALL TO THE FLOOR. THE PT SUFFERED SUPERFICIAL INJURY FROM THE FALL. HOWEVER, THE PT DIED THE DAY FOLLOWING THE INCIDENT.
THIS REPORT INDICATES THE DEATH WAS NOT A RESULT OF THE INCIDENT, BUT A CONDITION FOR WHICH THE PT WAS SUBMITTED TO HOSP FOR. THE PT WAS IN HOSP FOLLOWING A CVA FOR INVESTIGATION INTO GASTRIC PROBLEMS. PT WAS QUITE HEAVY WITH VERY LITTLE ABILITY TO MOVE ON HER OWN, TAKING TWO NURSES TO STAND HER.PT WAS TAKEN FROM WARD AND TRANSPORTED ON SUB-CHASSIS. ALL SEEMED WELL AND PT APPEARED SECURE ON THE CHAIR. SOMEONE WAS ABOUT TO PUT PT INTO BATH ON LIFT BY HERSELF. DURING THE CONNECTION OF THE CHAIR ON THE SUB-CHASSIS TO THE LIFT, PT TIPPED FORWARD WITH THE CHAIR AND SUB-CHASSIS AND LANDED FRONT DOWNWARDS ON THE FLOOR, CHAIR AND SUB-CHASSIS STILL IN PLACE AROUND HER. THE FALL RESULTED IN A BUMP AND BRUISING OVER RIGHT EYE AND A LACERATION TO RT KNEE. PT DIED ON 08/26/96. POST MORTEM REPORTED THAT THIS WAS NOT DUE TO FALL BUT FROM THE REASON SHE WAS ADMITTED TO HOSP. SIMULATION OF CHAIR-HOIST FAULT WAS CREATED BY CO INVESTIGATOR BUT COULD NOT BE DUPLICATED AND THEREFORE A CLEAN BILL OF HEALTH WAS GIVEN TO LIFT WHICH CONTINUES TO BE USED. THE NURSE WAS REPORTED TO HAVE SAID THAT DURING THE LIFT, A CLICK OF THE SAFETY CATCH, INDICATING THAT CHAIR WAS SECURE ON HOIST, WAS NOT HEARD. A COPY OF OPERATING INSTRUCTIONS LEAFLET TO BE SENT TO WARD AND ESTATE'S DEPT. A DEMO ON CORRECT USE OF LIFT HAS BEEN OFFERED. AWAITING CUSTOMERS INSTRUCTIONS ON PRODUCT DEMO.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE IMPLANT DID NOT INTEGRATE INTO A GRAFTED SITE, AND THE DR INDICATED POOR BONE QUALITY AS A CONTRIBUTING FACTOR.
H6: 86 = DIMENSIONAL ANALYSIS. 100 = DEVICE MET INTERPORE VISUAL DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
THE VALVE WAS REMOVED DUE TO CALCIFICATION AND CUSPAL STIFFENING. VALVE IMPLANTED 12 MONTHS. PT AGE AT IMPLANT 75.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED". MEDWATCH FORM WAS NOT REC'D FROM THE USER FACILITY THEREFORE, INFO WAS FILLED IN BY CO WITH INFO REC'D FROM THE MD. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A". H6 ANALYSIS CODES: RESULTS CODE #100 OTHER= THROMBOTIC MATERIAL. CONCLUSION CODE #68 OTHER=DEVICE PERFORMED AS EXPECTED AND WAS RELATED TO THE REPORTED EVENT. ANALYSIS: THE ANALYSIS SHOWS THAT THE CUSPAL STIFFENING WAS THE RESULT OF A GRANULAR, THROMBOTIC APPEARING HOST MATERIAL THAT FILLS THE OUTFLOW ASPECT OF TWO LEAFLETS. THE RADIOGRAPH SHOWS THE VALVE TISSUE TO BE FREE OF MINERALIZATION. AS A RESULT OF THE ANALYSIS CO WOULD NOT AGREE WITH THE PT CODE #1758=CALCIFICATION, AS REPORTED BY THE MD, AND WOULD INSTEAD USE THE PT CODE #2100=THROMBOSIS, WHICH IS ALSO LABELED.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 6/28/95 AND REVISED ON 4/23/97 DUE TO "FLUID LOSS". ADDITIONALLY, THE INFO INDICATED THAT THE "TUBING BROKE AT (THE) CYLINDER JUNCTION". A RESIPUMP AND TWO CYLINDERS WERE RETURNED FOR EVAL. REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT, HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A SEPARATION/LEAKAGE SITE IN CYLINDER #2'S STRAIN RELIEF AT THE APEX. EXAMINATION OF THE SURFACES OF THE SEPARATION REVEALED MARKINGS CHARACTERISTIC OF STRESS(S) INDUCED RENDING. OPPOSITE THE SEPARATION A CREASE MARK IS OBSERVED. BASED ON QA'S EXAMINATION AND THE LIMITED INFO RECEIVED, QA CONCLUDED THAT WHILE IN-VIVO CYLINDER #2'S STRAIN RELIEF WAS PARTIALLY KINKED. QA FURTHER CONCLUDED THAT THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE STRAIN RELIEF AT THE NOTED SITE. THIS RENT WOULD ALLOW THE NOTED "FLUID LOSS" AND RENDER THE DEVICE INOPERABLE.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO A "FLUID LOSS", SECONDARY TO "BROKEN TUBIN AT RIGHT CYLINDER JUNCTION". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MENTOR DEVICE.
THE DEVICE WAS REMOVED AT IT WAS "NOT FUNCTIONING".
EVAL. AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL. WILL BE FORWARDED UPON COMPLETION.
THE DEVICE WAS REMOVED DUE TO "LEAKAGE", SECONDARY TO A "TUBING SHEAR". THE ENTIRE DEVICE WAS REMOVED.
EVAL. AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OF USUAL FOR SERVICE. AN EVAL. WILL BE FORWARDED UPON COMPLETION.
THE DOCTOR HAD DIFFICULTY INSERTING THE IAB INTO THE PT ON 8/21/96. AFTER THE IAB WAS INSERTED, THERE WERE NO FURTHER PROBLEMS AND NO BLOOD WAS NOTED ANYWHERE.  WHEN THE IAB WAS REMOVED ON 8/22/96, THE PT'S ARTERY GOT TORN AND THE PT NEEDED SURGERY TO HAVE THE ARTERY REPAIRED. THE CONTACT AT THE FACILITY STATED THAT "IT LOOKED LIKE THE TIP OF THE IAB RECOILED."
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE LABEL CODE: 1738. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE ENTIRE LENGTH OF INNER LUMEN WITH THE MEMBRANE NOTED TO BE SEVERELY KINKED AND ELONGATED. THE MEMBRANE AT THE PROXIMAL TAPER WAS OBSERVE TO BE STRETCHED. THE SHEATH WAS NOTED TO BE KINKED ALONG ITS ENTIRE LENGTH. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE DEVICE. NO BLOOD WAS NOTED WITHIN THE MEMBRANE. IT WAS NOT POSSIBLE TO PUMP THE IAB ON THE LABORATORY SYSTEM 90 DUE TO THE CONDITION OF THE BALLOON MEMBRANE. IT WAS REPORTED THAT DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE FROM THE PATIENT YET NO BLOOD OR LEAK WAS FOUND IN THE IAB TO ACCOUNT FOR THIS ENCOUNTERED PROBLEM. THE CONDITION OF THE RETURNED IAB (STRETCHED MEMBRANE, ELONGATED AND KINKED INNER LUMEN, SEVERELY KINKED SHEATH) IS CONSISTENT WITH THAT OF AN IAB IN WHICH DIFFICULTY WAS ENCOUNTERED DURING REMOVAL ALONG WITH THE ASSOCIATED PATIENT INJURY. ALTHOUGH CONJECTURAL, IT IS POSSIBLE THAT THE PATIENT'S ANATOMY CONTRIBUTED TO THE REPORTED DIFFICULTY OR THAT THE MEMBRANE BECAME "BUNCHED" AGAINST THE SHEATH WHEN THE ATTEMPT WAS MADE TO REMOVE THE DEVICE FROM THE PATIENT'S ARTERY. THIS MEMBRANE "BUNCHING" COULD HAVE CONTRIBUTED TO THE REPORTED PROBLEM.
ON 8/1/96, THE FACILITY NURSE CONTACTED A MFR NURSE AND REPORTED THAT NURSE HAD ACCESSED THE DEVICE TO PERFORM A DEVICE REFILL AND GOT A "TINY BIT BACK IN THE TUBING." THE FACILITY NURSE THEN STARTED TO REFILL THE DEVICE AND DID NOT GET A RETURN OF 1CC FOR EVERY 5CC INJECTED. AFTER INSTILLING 20CC, THE PROCEDURE WAS DISCONTINUED. SEVERAL OTHER FACILITY NURSES ATTEMPTED TO REFILL THE DEVICE WITHOUT SUCCESS. THE FACILITY NURSE STATED THAT "IT FEELS LIKE METAL WHERE THE DEVICE SEPTUM SHOULD BE." THE MFR NURSE THEN RECOMMENDED THE PHYSICIAN BE NOTIFIED AND SERUM ANTIBIOTIC LEVELS BE OBTAINED TO MONITOR THE PT. IN ADDITION, THE MFR NURSE INFORMED THE FACILITY NURSE THAT THE DEVICE MAY HAVE FLIPPED AND IT WOULD BE NECESSARY TO PERFORM A REVISION AND IF IT HAD NOT, THE DEVICE CAN BE REFILLED WITH FLUOROSCOPIC GUIDANCE. THE MFR NURSE ALSO STATED THAT IF THE NURSE WAS UNSURE OF DEVICE ACCESS, USING A 10CC SYRINGE, SHE SHOULD INJECT 5CC OF SALINE AND ALLOW IT TO RETURN; IF IT DOES NOT, THE NEEDLE IS NOT PROPERLY PLACED IN THE DEVICE SEPTUM. ONCE THE NURSE IS SURE OF ACCESS,  SHE COULD THEN REFILL THE DEVICE. THE FACILITY NURSE STATED THAT SHE WOULD CONTACT THE PHYSICIAN AND REVIEW THE MFR'S NURSE'S RECOMMENDATIONS.
ON 8/13/96, THE FACILITY NURSE CONTACTED THE MFR NURSE AND REPORTED THAT THERE HAD ACTUALLY BEEN "NO PROBLEM" WITH THE DEVICE. THE NURSES HAD NOT BEEN ACCESSING THE DEVICE PROPERLY AND THE FACILITY NURSE HERSELF HAD ACCESSED AND REFILLED WITH DEVICE WITHOUT DIFFICULTY. THE FACILITY NURSE ALSO STATED THAT THE DEVICE IS FUNCTIONING AS INTENDED AND WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. IN ADDITION, THE FACILITY NURSE STATED THAT THE OTHER FACILITY NURSES HAVE BEEN TAUGHT HOW TO ACCESS THE DEVICE CORRECTLY. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
DURING A DIALYSIS TREATMENT, THERE WAS EXCESS WEIGHT REMOVAL. MEDICAL INTERVENTION WAS REQUIRED. PT'S BLOOD PRESSURE DROPPED AND PT LOST CONSCIOUSNESS.
A DIALYSIS MACHINE REMOVED 2 KG TOO MUCH FLUID. SALINE WAS ADMINISTERED AS A MEDICAL. THE MEDICAL EQUIPMENT SERVICE TECH (MES) FOUND THAT THE PRV3 CRACK PRESSURE WAS AT 730 MMHG. HE RECALIBRATE PRV3 TO 1015 MMHG. THE PRESSURE SPECIFICATION FOR PRV3 IS : 930-1035 MMHG. THERE WERE NOT RELATED CPF DEFECTS REPORTED. NO PART WAS RETURNED FOR THIS SERVICE CALL SINCE THE PART WAS RECALIBRATED AND RE-INSTALLED. THE EXACT REASON FOR THE CRACK PRESSURE'S TO 730 MMHG IS NOT KNOWN. HOWEVER, THE CHANGE IN CRACK PRESSURE, PER THE FOLLOWING ANALYSIS, CLEARLY DOES NOT APPEAR TO BE CAUSED BY A GRADUAL DRIFT IN THE SETTING. IF PRV3 DRIFTS GROSSLY OUT OF SPECIFICATIONS (LOW TO ABOUT 500-700 MMHG), IT IS POSSIBLE THAT IT COULD OPEN AN ALLOW UNACCOUNTED-FOR FLUID REMOVAL FROM THE PT. HOWEVER, INAPPROPRIATE OPENING OF THE VALVE CAN BE DETECTED SINCE THE KUF OF THE DIALYZER WOULD BE INAPPROPRIATE (THE KUF SHOULD BE CHECKED PER THE OPERATOR'S HANDBOOK AT THE BEGINNING OF EACH DIALYSIS). AUTOTEST IS A SECOND SYSTEM TEST WHICH WOULD IDENTIFY THE INCORRECT PRV-3 SETTING. BOTH AUTOTEST AND THE KUF CHECK ARE DONE BEFORE THE PT GEST ON THE MACHINE. ADDITIONALLY, AS THE ATTACHED DATA INDICATE, PRV-3 DRIFT IS 13.4 MMHG  4.24 MMHG (1 STANDARD DEVIATION). THUS, THERE ARE OVER 5 STANDARD DEVIATIONS BETWEEN THE 700 MMGH VALUE AT WHICH A PRV-3 MAY STAR TO LEAK AND THE MINIMUN CALIBRATION SETTING FOR PRV-3 OF 930 MMHG. THEREFORE, THERE IS LESS THAN A REMOTE CHANCE THAT A PRV-3 WOULD "DRIFT" TO A LOW ENOUGH VALUE TO LEAK BETWEEN PM'S. IT IS MUCH MORE LIKELY THAT THE SETTING OF THE PRV CHANGED DUE TO AN UNIDENTIFIED EVENT RATHER THAN GRADUAL DRIFTING. THIS MDR RESPONSE WAS EXTENDED TO GATHER INFORMATION FROM THE FIELD REGARDING THE DEGREE OF PRV-3 DRIF BETWEEN CALIBRATION PERIOD. THE COMPLAINT FAILURE WAS TRACED TO AN CHANGED IN THE SETTING OF THE PRV DUE TO AN EVENT OF UNK ORIGIN. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATION, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. FAILURE CODES: F. CODE PRRVS097WL. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 9/3/95 AND REVISED ON 12/6/95 DUE TO AN "INFECTION." THE PHYSICIAN STATED THAT SYMPTOMS OF INFECTION WERE NOTED IN 11/95 AND THE PT HAD NO DIFFICULTY WITH THE DEVICE UNTIL THAT TIME. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE INFECTION REPORT. THE REVIEW OF THE DEVICE HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THE KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
THE PT WAS IMPLANTED WITH A PROSTHESIS ON 3/14/96. SUBSEQUENTLY THE PHYSICIAN NOTED THAT THE PT'S LEFT BREAST HAD DEVELOPED AN INFECTION. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I(B) , THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVAL ATTACHED HERETO.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738 AND POSITION 2: 1701. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL.
EVENT COMPLICATIONS: PATIENT EXPIRED/UNK IF RESULT OF EVENT-RPT'D 8/27/96, 2/24/97. PATIENT'S CURRENT STATUS: EXPIRED - RPT'D 8/27/96.
ON 8/27/96, DR STATED THE PT HAD A BURN ABOVE THE SURGICAL SITE AND HE BELIEVED IT WAS FROM THE WSU PENCIL.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO THE PT HAVING DIFFICULTY URINATING.
BOTH CYLINDERS DID NOT PASS THE BEND TEST.
DURING AN INVESTIGATION INTO A SUBSEQUENT EVENT, A PREVIOUSLY UNREPORTED EVENT WAS DISCOVERED. PER THE INFO PROVIDED TO CO THROUGH MEANS OF THE PHYSICIAN'S OPERATIVE NOTES, "THE PT DEVELOPED FAILURE OF THE FUNCTION OF THE PROSTHESIS. THIS WAS FOUND TO BE SECONDARY TO A SCROTAL ABSCESS. AT THAT TIME, THE PT HAD DRAINAGE OF THE SCROTAL ABSCESS AND THE RESIPUMP OF THE PROSTHESIS WAS THEN PLACED IN A DIFFERENT AREA." NO DEVICE, NOR DEVICE COMPONENT(S) WERE REMOVED OR REPLACED.
IN THE RECEIVED INFO THE PHYSICIAN STATED THAT THE PT PRESENTED WITH A SCROTAL ABSCESS. THE PHYSICIAN THEN PROCEEDED WITH "DRAINAGE OF THE SCROTAL ABSCESS AND THE RESIPUMP OF THE PROSTHESIS WAS THEN PLACED IN A DIFFERENT AREA." BECAUSE NO COMPONENTS WERE REMOVED QA CANNOT COMMENT ON THE CONDITION OF THE PROSTHESIS, HOWEVER, BECAUSE QA'S EXAMINATON OF THE PROSTHESIS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF A SCROTAL ABSCESS, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT ANY INFECTION THAT MAY HAVE BEEN PRESENT ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
DEVICE WAS REMOVED FROM THE PT DUE TO SST DEFORMITY AND PT DISSATISFACTION. ANOTHER DEVICE WAS IMPLANTED.
DEVICE WAS REMOVED FROM THE PT DUE TO PAIN. ANOTHER DEVICE WAS IMPLANTED.
THE PROSTHESIS WAS REMOVED DUE TO "EROSION". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MALLEABLE PROSTHESIS.
BECAUSE QA'S EXAMINATION OR THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF EROSION, QA DID NOT PERFORM A MICRSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE REPORT OF EROSION AS THE REASON FOR SURGICAL INTERVENTION. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
THE PROCEDURE WAS AN ACHILLES TENDON. NOBODY IS REALLY SURE WHAT HAPPENED. THE TECH KEPT TOUCHING THE HEMOSTAT BUT THERE WAS NO POWER. THE GROUNDING PAD WAS CHECKED-IT WAS FINE, THE RESISTANCE WAS GOOD. THE PENCIL WAS PLUGGED IN. THE PAD AND PENCIL WERE CHANGED AND IT WORKED. DURING THE PROCEDURE, A HEMOSTAT WAS LAYNG ON THE LEG. A WHITE SPOT WAS NOTICED AFTER THE PROCEDURE. SILVADENE CREAM WAS APPLIED. SINCE, THE DR HAS MENTIONED HE FELT SMALL SHOCKS IN HIS FINGERS DURING THE PROCEDURE. THE BURN BECAME INFECTED. IT WAS A FULL THICKNESS BURN ON THE ANKLE ABOUT THE SIZE OF AN OBLONG NICKEL. DR WAS USING WET TO DRY DRESSINGS. IF IT DOES NOT HEAL, THE DR MAY DEBRIDE. THE DEVICE WAS RETURNED FOR EVALUATION ON 8/28/96. EVALUATION OF THE INCIDENT DEVICE BY CO WAS CONDUCTED AND THE PENCIL WAS FOUND TO BE ACTIVATING PROPERLY. VISUAL EXAMINATION OF THE PENCIL DID NOT REVEAL ANY RF PENETRATION OF THE PLASTIC MATERIAL AND ALL SEAMS ON THE PENCIL HOUSING WERE INTACT WITH NO OPEN AREA TO THE METAL SHAFT OF THE ELECTRODE. THERE WAS NO INDICATION ON THE HOUSING OF ANY BURNED AREAS OR CHARRING, NOTHING INSIDE THE HOUSING. ALL INDICATIONS WERE, THE PENCIL ACTIVATION WAS NORMAL AND THE RF PATH HAD BEEN ESTABLISHED FROM THE ACTIVE ELECTRODE AREA. NO DETERMINATION COULD BE MADE AS TO HOW THE DEVICE MAY HAVE BEEN ACTIVATED TO CAUSE THE INCIDENT. THE DESCRIPTION DID NOT INDICATE THERE WERE ANY SELF OR LOCK-UP ACTIVATION PROBLEMS WITH THE DEVICE, ALL OTHER FUNCTIONS OF THE DEVICE WERE NORMAL. THE DESCRIPTION PROVIDED CO INDICATED THERE WAS A BURN ON THE LEG UNDER AN AREA WHERE A HEMOSTAT WAS LAYING. SINCE THERE WAS NO CHARRED AREAS ON THE DEVICE OR CABLE, IT COULD NOT BE DETERMINED HOW THIS INCIDENT COULD HAVE OCCURRED, OR HOW THE DEVICE WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE USER IS REMINDED THAT WHEN ACTIVATED, INADVERTENT CONTACT WITH THE ELECTRODE AND THE PT OR STAFF SHOULD NEVER BE ALLOWED. ANY METAL OBJECT TOUCHING THE PT CAN BECOME A RF PATHWAY IF CONTACT IS MADE. CODE #1757 -NOT LABELED. CODE #1117 -NOT LABELED.
INFO RECEIVED ON 8/21/96 INDICATES A REVISION SURGERY OCCURRED ON 5/20/96, ORIGINAL DETAILS AND REASON NOT GIVEN. CO HAS REQUESTED ADD'L INFO.
THE PT WAS IMPLANTED WITH A SMOOTH SALINE PROSTHESIS ON 11/22/95. ON 12/18/95 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION IN THE LEFT BREAST AND REMOVED THE PROSTHESIS. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED, THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION". SEE PRODUCT EVAL ATTACHED HERETO. ADDITIONAL INFO TO BE SUBMITTED Y/N? YES. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING IS NO. IF "YES" IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT ? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? YES. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING?. N.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION - DID NOT LIKE IT.
THE "GAS LOSS" ALARM SOUNDED FROM THE SYSTEM 95 PUMP. THE DOCTOR CHECKED THE IAB BUT FOUND NO PROBLEM. THE "GAS LOSS" ALARM SOUNDED AGAIN AND THE DOCTOR TRIED TO REMOVE THE IAB BUT WAS UNABLE TO. THE IAB WAS SURGICALLY REMOVED. BLOOD WAS NOTED IN THE BALLOON. THERE WERE NO FURTHER COMPLICATIONS TO THE PT. THE IAB WAS NOT RETURNED TO CO FOR EVAL. THE IAB WAS DISCARDED BY THE FACILITY.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVAL. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. THIS FORM WAS COMPLETED BY THE MANUFACTURER.
BAG DID NOT DRAIN PROPERLY AND URINE BACKED UP INTO THE PT'S BLADDER. PT DEVELOPED URINARY TRACT INFECTION AND WAS TREATED WITH ANTIBIOTICS.
CENTER REPORTED THAT 3 HRS INTO THE HEMODIALYSIS TREATMENT WHILE EATING A CRACKER, THE CHOKED, GASPED AND HUNCHED OVER IN THE CHAIR. A CARDIAC MONITOR SHOWED VENTRICULAR FIBRILLATION AND PT ARRESTED. THE MD WAS PRESENT IN THE UNIT AT THE TIME OF THE INCIDENT AND PRONOUNCED THE PT DEAD IN THE UNIT. NO DEVICE ALARMS NOTED AT  OR PRIOR TO THE INCIDENT. CAUSE OF DEATH WAS REPORTED AS: CARDIAC ARREST. PER DIR OF NURSING, THE PT WAS USING A 0 K+ CONCENTRATE AT THE TIME OF THE INCIDENT.
PER MED WATCH #182507-19960085 IT STATED THE DEVICE HAD DISCREPANCIES IN THE DIALYSATE FLOW RATE, BLOOD FLOW RATE AND BLOOD LEAK TEST ALARM. PER UNIT MACHINE TECHNICIAN REPORT, BLOOD FLOW RATE, DIALYSATE RATE AND BLOOD LEAK TEST ALARM WERE FUNCTIONING PROPERLY AFTER THE INCIDENT. A CO EVAL. CONFIRMED THE BLOOD FLOW RATE AND BLOOD LEAK TEST ALARMS WERE FUNCTIONING WITHIN THE MFR'S SPECIFICATIONS. PER CO MEDICAL DIR, THE CONCLUSION CODING FOR THE EVAL OF THE DEVICE IS ACCURATE AND THE CHOICE BY THE UNIT TO USE A 0 K+ CONCENTRATE CONTRIBUTED TO THE PT'S DEATH. AN EVAL BY CO FIELD SERVICE ENGINEER FOUND THE CONDUCTIVITY, TEMPERATURE AND ALL ALARM FUNCTIONS TO BE WITHIN MFR'S SPECIFICATIONS. THE DIALYSIS FLOW RATE WAS FOUND ELEVATED. THE DEVICE WAS RECALIBRATED AND PER DIALYSIS UNIT, IS BACK IN SERVICE WITHOUT INCIDENT.
WHEN THE IAB WAS REMOVED, A NEGATIVE PRESSURE WAS DRAWN WITH A SYRINGE AND DIFFICULTY WAS ENCOUNTERED REMOVING THE IAB. THE CONTACT STATED THAT THE MEMBRANE FOLDED UP OVER THE TIP WHEN THE IAB WAS REMOVED, AND THE PT'S ARTERY GOT TORN. PRESSURES WERE APPLIED TO THE ARTERY AND THE PT'S CURRENT STATUS IS "OK". NO LEAK WAS NOTED DURING IABP.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE LABEL CODE: 1738. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY UNFOLDED. BLOOD WAS NOTED ONLY ON THE EXTERIOR OF THE IAB. THE SHEATH WAS NOTED TO BE KINKED. NO LEAK WAS OFUND IN THE IAB. THE BALLOON PUMPED SATISFACTORILY ON THE LABORATORY SYSTEM 90 AT 80 AND 160 BPM. NO ALARMS WERE TRIGGERED. PROBABLE CAUSE OF DIFFICULTY: NO DEFECT WAS FOUND IN THE RETURNED DEVICE. THE PHYSICAL CONDITION OF THE RETURNED IAB IS NOT QUITE CONSISTENT WITH THAT OF AN IAB IN WHICH DIFFICULTY WAS REMOVING THE DEVICE FROM THE PATIENT. UNFORTUNATELY, IT IS NOT POSSIBLE TO DETERMINE THE EXACT REASON FOR THE ENCOUNTERED PROBLEM. DIFFICULTY REMOVING THE IAB FROM THE PATIENT MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: A KINK IN THE CATHETER TUBING TRAPPED HELIUM IN THE MEMBRANE PREVENTING IT FROM FULLY COLLAPSING UNDER NORMAL ARTERIAL PRESSURE ALLOWING FOR EASY REMOVAL OF THE BALLOON FROM THE PATIENT. THE PATIENT'S ANATOMY (TORTUOUS VESSELS). DURING IAB REMOVAL, THE MEMBRANE BECAME "BUNCHED" AT THE SHEATH TIP CAUSING INCREASED RESISTANCE DURING IAB REMOVAL.
CENTER REPORTED 3.45 HRS INTO THE HEMODIALYSIS TREATMENT THE PT GASPED. A CARDIAC MONITOR SHOWED VENTRICULAR FIBRILLATION AND PT THEN ARRESTED. THE MD WAS PRESENT IN THE UNIT AT THE TIME OF THE INCIDENT AND PRONOUNCED THE PT DEAD IN THE UNIT. NO DEVICE ALARMS NOTED AT OR PRIOR TO THE INCIDENT. CAUSE OF DEATH IS REPORTED AS: CARDIAC ARREST. PER DIR OF NURSING, THE PT WAS USING A 0 K+ CONCENTRATE AT THE TIME OF THE INCIDENT.
PER MED WATCH #182507-1996-0086 IT STATED THE DEVICE HAD DISCREPANCIES IN THE DIALYSATE FLOW RATE, BLOOD FLOW RATE AND BLOOD LEAK TEST ALARM. PER UNIT MACHINE TECHNICIAN REPORT, BLOOD FLOW RATE, DIALYSATE RATE AND BLOOD LEAK TEST ALARM WERE FUNCTIONING PROPERLY AFTER THE INCIDENT. A CO EVAL CONFIRMED THE BLOOD FLOW RATE AND BLOOD LEAK TEST ALARM WERE FUNCTIONING WITHIN THE MFR'S SPECS. PER CO MEDICAL DIR THE CONCLUSION CODING FOR THE EVAL OF THE DEVICE IS ACCURATE AND THE CHOICE BY THE UNIT TO USE A 0 K+ CONCENTRATE CONTRIBUTED TO THE PT'S DEATH. AN EVAL BY CO FIELD SERVICE ENGINEER FOUND THE CONDUCTIVITY, TEMPERATURE AND ALL ALARM FUNCTIONS TO BE WITHIN THE MFR'S SPECIFICATIONS. THE DIALYSATE FLOW RATE WAS FOUND ELEVATED. THE DEVICE WAS RECALIBRATED AND PER DIALYSIS UNIT, IS BACK IN SERVICE WITHOUT INCIDENT.
THE PT WAS BILATERALLY IMPLANTED WITH SALINE PROSTHESIS ON 5/17/93. SUBSEQUENTLY THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AUTO-IMMUNE TYPE SYSTEMS, SUCH AS LUPUS, ARTHRITIS, IRRITABLE BOWLS AND CHANGE IN TEXTURE OF SKIN ALONG WITH WRINKLING OF BOTH IMPLANTS. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED, THEREBY ; MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I(B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVAL ATTACHED HERETO. ADD'L INFO TO BE SUBMITTED Y/N? YES. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? YES. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N.
THE SURGEON RECENTLY SAW THE PT WHO WAS SUBJECT OF ORIGINAL MDR FILED DUE TO A POSSIBLE IMPAIRMENT OF A BODY FUNCTION. THE PT'S SYMPTOMS HAD GREATLY IMPROVED. SPECIFICALLY, THE PT IS NO LONGER EXPERIENCING THROAT SORENESS AND THE LESIONS ON THE PT'S LOWER LIP HAVE RESOLVED. ALTHOUGH THE PT IS STILL REPORTING SOME TONGUE NUMBNESS, THE SURGEON INDICATED THIS SYMPTOM IS CONSISTENT WITH THE STRETCHING OF THE CHORDA TYMPANI NERVE DURING SURGERY. THE SURGEON INDICATED THE TONGUE NUMBNESS SHOULD RESOLVE, SINCE THE NERVE IS INTACT. THIS FILE WILL BE CONSIDERED CLOSED AS THE REMAINING SYMPTOMS IS CONSISTENT WITH THE SURGERY AND IS BEING MANAGED BY THE SURGEON. IF DISTRIBUTOR SHOULD RECEIVE ANY ADDITIONAL INFO REGARDING THIS EVENT IT WILL BE FORWARDED TO THE AGENCY.
DEVICE LABEL CODES: 1738, 1738. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE BALLOON COMPLETELY NOTED TO BE ALMOST COMPLETELY WITHIN THE SHEATH TUBING. THE MEMBRANE AND INNER LUMEN WITHIN THE DEVICE WAS NOTED TO BE SEVERELY STRETCHED. IT WAS NOT POSSIBLE TO PUMP THIS IAB ON THE LABORATORY SYSTEM 90 DUE TO THE CONDITION OF THE RETURNED DEVICE. PROBABLE CAUSE OF DIFFICULTY: THE CONDITION OF THE RETURNED MEMBRANE AND SHEATH SUGGESTS THAT THE BALLOON MEMBRANE DID NOT FULLY EXIT THE SHEATH TUBING. IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED DIFFICULTY BASED ON THE EVENT DESCRIPTION AND THE EXAMINATION OF THE ITEM. THIS TYPE OF COMPLANT IS ONE OF THE MOST DIFFICULT TO EVALUATE AND MUST RELY ON CONJECTURE SINCE ONE CANNOT OBSERVED WHAT THE BALLOON IS BEING SUBJECTED TO WITHIN THE AORTA. IN GENERAL, POOR AUGMENTATION AND ALARM DIFFICULTIES MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: 1. THE IAB MEMBRANE FAILED TO FULLY EXIT THE SHEATH (THE CONDITION OF THE RETURNED IAB SUPPORTS THIS STATEMENT. 2. THE BALLOON ENTERED A SUBINTIMAL SPACE. 3. THE BALLOON WAS PLACED TOO HIGH IN THE AORTIC ARCH OR IN THE SUBCLAVIAN ARTERY. 4. THE IAB FAILED TO COMPLETELY UNFOLD BECAUSE THE USER FAILED TO INJECT AT LEAST 30CC. OF AIR AS ADVISED IN THE INSTRUCTIONS FOR USE. 5. THE CATHETER KINKED WITHIN THE PATIENT PROBABLY BECAUSE OF SEVERE VESSEL TORTUOSITY AND/OR PATIENT MOVEMENT. 6. THE CATHETER KINKED OUTSIDE THE PATIENT. THE USER MAY HAVE FAILED TO SECURE THE CATHETER AND Y-FITTING TO THE PATIENT. MANIPULATION OF THE KINKED PORTION OF THE CATHETER CAN MINIMIZE THE RESTRICTION AND IMPROVE BALLOON PERFORMANCE. 7. A KINK IN THE CATHETER MAY HAVE RESTRICTED THE FLOW OF HELIUM INTO AND OUT OF THE BALLOON CAUSING THE PUMP TO PERCEIVE A LOSS OF GAS OR TO CAUSE THE BALLOON TO POORLY AUGMENT. 8. THERE WAS A LOOSE CONNECTION BETWEEN THE IAB AND THE PUMP OR BETWEEN THE PUMP AND THE SAFETY CHAMBER. CHECKING THESE CONNECTIONS MAY ALLEVIATE THE PROBLEM. 9. THE BALLOON PUMP NEEDED SERVICING. 10. THE PATIENT'S PHYSIOLOGICAL CONDITIONS CONTRIBUTED TO THE REPORTED PROBLEM. THESE CAN INCLUDE LOW MEAN ARTERIAL BLOOD PRESSURE, LOW SYSTEMIC VASCULAR RESISTANCE, OR A RAPID HEART RATE THAT COMPROMISED VENTRICULAR FILING AND EJECTION.
THERE WERE NO COMPLICATIONS FROM THE EVENT AND THE PATIENT WAS DISCHARGED FROM THE FACILITY. EVENT COMPLICATIONS: CHEST PAIN - REPORTED 9/3/96; NONE - REPORTED 11/7/96. PATIENT'S CURRENT STATUS: DISCHARGED - RPT'D 11/7/96.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. H11. F10 CODES: PT CODE #1762-NOT LABELED. DEVICE CODE #1599-NOT LABELED. CO WOULD NOT CLASSIFY THE DEVICE CODE AS #1599 BUT WOULD CONSIDER #1309 AS A BETTER DISCRIPTION AND ONE THAT IS LISTED IN THE LABELING. H.6 EVALUATIONS CODES-METHOD CODE 86-DEVICE HISTORY REVIEWED. RESULTS CODE 100-PACKAGING INSERT CONTAINS ADAQUATE INSTRUCTIONS FOR USE AND WARNINGS FOR POSSIBLE EVENTS. THIS EVENT WAS REPORTED TO MEDTRONIC BY A HOSPITAL DEVICE EXPLANT FORM. A MEDWATCH FORM WAS REC'D FROMT HE HOSP AFTER REQUESTED BY CO AND IS ATTACHED. ADD'L INFO NOT PROVIDED ON THE USER FACILITY REPORT HAS BEEN COMPLED PER INFO FROM TO MD TO THE MFR. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. H3 ANALYSIS: DHR WAS REVIEWED AND INDICATED THAT THE PRODUCT MET ALL FUNCTIONAL AND DIMENSIONAL SPECS WHEN RELEASED FOR CLINICAL USE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION AND TOTAL PERFORATION OF THE BULBOUS URETHRA.
THE BALLOON WAS REMOVED FROM THE PT DUE TO FLUID LOSS - BALLOON EMPTY.
INTRA-AORTIC BALLOON PUMP CATHETER PLACED AT APPROX 0515 FOR INTRACTABLE ANGINA, AWAITING CORONARY ARTERY BYPASS GRAFT SURGERY. BALLOON CATHETER RUPTURED AT 1145 SAME DAY AS EVIDENCED BY NO AUGHMENTATION OF BLOOD PRESSURE. ALARM HAD SOUNDED. INITIAL NURSING ASSESSMENT: DECREASE AUGMENTATION, DECREASE AFTERLOAD, NO LINE KINKS, NO BLOOD IN TUBING, REFILLED AND ZEROED AND RESUMED PUMP. CONTINUED TO ALARM, PT C/O ABDOMINAL PAIN, PINK FLUID NOTED IN TUBING. BALLOON CATHETER AND SHEATH EXCHANGED OVER GUIDE WIRE. ADDENDUM 8/26/96: REPLACEMENT WAS UNSUCCESSFUL AS HEMATOMA DEVELOPED AFTER REMOVAL OF RUPTURED CATHETER.
PT CLAIMS TO HAVE UNDERGONE A VENTRAL HERNIA REPAIR SURGERY ON 11/19/93. PT ALLEGES THAT CONSEQUENCE OF SURGERY, PT EXPERIENCES HYPERTENSION, PAIN AND TENDERNESS IN LOWER ABDOMEN WHERE MESH WAS PLACED, POLYARTHRITIS, FEVER AND CHRONIC FATIGUE. THE MESH WAS REMOVED ON 9/11/95 WHERE MESH WAS REPORTED TO HAVE BEEN INCORPORATED INTO THE LIVER WHICH REQUIRED EXCISION OF A PORTION OF LIVER AND ABDOMINAL MUSCLES.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO IT BEING TOO LONG.
THE AFFECTED INDIVIDUAL CLAIMS HE/SHE DEVELOPED SEVERE ILLNESSES AND INJURIES TO SKIN SUCH AS DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS ALLEGEDLY CAUSED BY EXTENDED EXPOSURE TO THE CHEMICAL SUBSTANCES OF THE GLOVES. CLAIMS ARE AGAINST MULTIPLE MFRS INCLUDING UNKNOWN ONES AND IT IS NOT CURRENTLY KNOWN WHOSE GLOVES WERE INVOLVED.
REFER TO BASELINE REPORT ATTACHED TO MDR#1520348-1996-00001. CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO HE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO PROTRUSION OUT ONE INCH AT END.
PUMP PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS.
INFO RECEIVED ON 10/02/96 INDICATES THE AMBICOR DEVICE WAS REMOVED FROM THE PT ON 9/18/96. AN IPP DEVICE WAS IMPLANTED.
THE IAB WAS INSERTED INTO THE PT ON 4/14/96 AT APPROX 0515 FOR INTRACTABLE ANGINA, AWAITING CORONARY ARTERY BYPASS GRAFT SURGERY. AN ALARM SOUNDED FROM THE PUMP. THE INITIAL NURSING ASSESSMENT WAS: DECREASE AUGMENTATION, DECREASE AFTERLOAD, NO LINE KINKS, NO BLOOD IN TUBING. THE IAB WAS REFILLED AND IABP CONTINUED BUT THE ALARM SOUNDED AGAIN. THEN AT 1145 THE SAME DAY, THE PT HAD ABDOMINAL PAIN AND PINK FLUID WAS NOTED IN THE TUBING. (CO RECEIVED THIS REPORT VIA THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT #2600-320000-1996-0015). THE IAB WAS NOT RETURNED TO CO FOR EVALUAITON. THE IAB WAS DISCARDED BY THE FACILITY. ANOTHER IAB WAS NOT INSERTED BECAUSE A HEMATOMA DEVELOPED AT THE INSERTION SITE AFTER THE BALLOON WAS REMOVED.
THE PTODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVALUATION. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. THIS FORM WAS COMPLETED BY THE MFR.
THE AFFECTED INDIVIDUAL CLAIMS HE/SHE DEVELOPED SEVERE ILLNESSES AND INJURIES TO SKIN SUCH DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND /OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS ALLEGEDLY CAUSED BY EXTENDED EXPOSURE TO THE CHEMICAL SUBSTANCES OF THE GLOVES. CLAIMS ARE AGAINST MULTIPLE MFRS INCLUDING UNKNOWN ONES AND IT IS NOT CURRENTLY KNOWN WHOSE GLOVES WERE INVOLVED.
REFER TO BASELINE REPORT ATTACHED TO MDR#1520348-1996-00001. CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH TEH CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CNCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO DISTAL STENOSIS CORPORA CAVERNOSA.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PAIN.
COMPLAINANT ALLEGED THAT STAFF MEMBERS WERE TREATING A PT (AGE AND GENDER UNK) WHO WAS IN A CODE SITUATION. THE STAFF DEFIBRILLATED THE PT SIX TIMES. ON THE SEVENTH DEFIBRILLATION ATTEMPT, AN "ERROR 44" MESSAGE APPEARED ON THE UNIT'S MONITOR SCREEN. THE STAFF OBTAINED ANOTHER UNIT AND CONTINUED TO TREAT THE PT. THE PT DID NOT SURVIVE THE CODE. THE COMPLAINANT INDICATED THAT THE ALLEGED MALFUNCTION DID NOT CONTRIBUTE TO THE PT OUTCOME.
REFER TO BASELINE REPORT ATTACHED TO MDR#1520348-1996-00001. CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEED, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEED CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION".
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO "MALFUNCTION."
REFER TO BASELINE REPORT ATTACHED TO MDR#1520348-1996-00001. CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIO TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THATTHE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO FLUID LOSS.
SUTURE BREAKAGE POST-OP REQUIRING RE-OP TO REPAIR. 17 SUTURE LOTS WERE RETURNED FOR EVAL DUE TO THE FACT THAT THE USER FACILITY DOES NOT KNOW WHAT SUTURES ARE IN QUESTION. LOTS MAY REPRESENT WHAT WAS USED DURING SURGERY. RE-OP TO REPAIR OCCURRED 10 DAYS AFTER INITIAL COLON RESECTION DUE TO WOUND DEHISCENCE. INTERNAL CONTROL NUMBER IS: 9600606-00.
H6- REPRESENTATIVE SAMPLES OF THE RETURNED PRODUCT WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND THE RESULTS OBTAINED WERE ABOVE THE CO'S REQUIREMENTS, WHICH ALWAYS EQUAL OR EXCEED THE MINIMUM USP REQUIREMENTS.
DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. A MALLEABLE DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO.
THE LEFT CYLINDER WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE LEFT CYLINDER WOULD NOT STAY INFLATED.
CYLINDER HAD A WEAR HOLE IN INNER TUBE. CYLINDER DOES NOT INFLATE.
PT WAS ADMITTED FOR LAPAROSCOPIC BURCH PROCEDURE, A & P REPAIR WITH POSBIEL RT OVARIAN CYSTECTOMY. THE NEEDLE FROM ENDO SUTURE BROKE WHILE PASSING THROUGH COOPERS LIGAMENT REQUIRING AN OPEN LAPAROTOMY TO RETRIEVE THE NEEDLE PIECES. (WHICH WAS DONE).
THE AFFECTED INDIVIDUAL CLAIMS HE/SHE DEVELOPED SEVERE ILLNESSES AND INJURIES TO SKIN SUCH DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS ALLEGEDLY CAUSED BY EXTENDED EXPOSURE TO THE CHEMICAL SUBSTANCES OF THE GLOVES. CLAIMS ARE AGAINST MULTIPLE MFRS INCLUDING UNKNOWN ONES AND IT IS NOT CURRENTLY KNOWN WHOSE GLOVES WERE INVOLVED.
REFER TO BASELINE REPORT ATTACHED TO MDR#1520348-1996-00001. CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. TEH REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS IMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSIONBY FDA, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
9/18/96 -PT CODE 1686 WAS PROVIDED BY THE USER FACILITY. MFR WAS UNABLE TO DETERMINE DEFINATION. SUBMITTED INITIAL REPORT. THE HOSP DID NOT RELEASE THE DEVICE FOR CO'S EVALUATION.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS - LEFT SIDE COULD NOT PUMP.
CYLINDER PERFORMED WITHIN SPECS. CYLINDER HAD A WEAR LEAK.
REFER TO BASELINE REPORT ATTACHED TO MDR#1520348-1996-00001. CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON ONFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED DUE TO "MALFUNCTION."
SUTURE BREAKAGE POST-OP REQUIRING RE-OP TO REPAIR. 17 SUTURE LOTS WERE RETURNED FOR EVAL DUE TO THE FACT THAT THE USER FACILITY DOES NOT KNOW WHAT SUTURES ARE IN QUESTION. LOTS MAY REPRESENT WHAT WAS USED DURING SURGERY. RE-OP TO REPAIR OCCURRED 10 DAYS AFTER INITIAL C-SECTION SURGERY DUE TO WOUND DEHISCENCE. INTERNAL CONTROL NO: 9600606-01.
REFER TO BASELINE REPORT ATTACHED TO MDR#1520348-1996-00001. CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 2 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
THE PT IS EXPERIENCING A DEVICE PROBLEM WHEREBY "THE PUMP SQUEEZES IN BUT DOES NOT REINFLATE".
AT THIS TIME, NO ADD'L ACTION, MEDICAL OR SURGICAL INTERVENTION HAS BEEN REPORTED. A REQUEST HAS BEEN MADE TO THE PHYSICIAN'S OFFICE THROUGH CO'S INTERNATIONAL REP FOR ADD'L INFO AND THE RETURN OF THE DEVICE SHOULD SURGICAL INTERVENTION OCCUR. THEREFORE, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE IMPLANTED DEVICE AND IF DEVICE FUNCTION IS CONTRIBUTES TO THIS OCCURRENCE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELLING OR USUAL FOR SVC. SHOULD ADD'L INFO, AND/OR THE DEVICE BECOME AVAILABLE, QA WILL FILE AN ADDENDUM TO THIS REPORT AS REQUIRED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED DUE TO FLUID LOSS - LEFT CYLINDER.
CYLINDER HAD A WEAR LEAK. CYLINDER HAD A WEAR HOLE IN INNER TUBE.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED APPROX 6MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX 81MM AND WAS RECEIVED WITH APPROX 2 MM OF THE DISTAL END PROTRUDING OUT OF THE OUTER POLYURETHANE INSULATION APPROX 6MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO APPROX 87MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT APPROX 41.5 CM PROXIMAL OF FIXATION HELIX HOUSING ELECTRODE TIP. WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURES AND PROTRUSION.
REFER TO BASELINE REPORT ATTACHED TO MDR#1520348-1996-00001. CO IS SUBMITTING THE ABOVVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. TEH REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO "MALFUNCTION", PUMP FAILURE.
REFER TO BASELINE REPORT ATTACHED TO MDR#1520348-1996-00001. CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
THE PT IS EXPERIENCING A DEVICE THAT "DOES NOT INFLATE". ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE "IS EMPTY".
AT THIS TIME, NO ADD'L ACTION, MEDICAL OR SURGICAL INTERVENTION HAS BEEN REPORTED. A REQUEST HAS BEEN MADE TO THE PHYSICIAN'S OFFICE FOR ADD'L INFO AND THE RETURN OF THE DEVICE SHOULD SURGICAL INTERVENTION OCCUR. THEREFORE, QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THIS EVENT. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SVC. SHOULD ADD'L INFO AND /OR THE DEVICE BECOME AVAILABLE, QA WILL PROVIDE AN ADDENDUM TO THIS REPORT AS REQUIRED.
SUTURE BREAKAGE POST-OP REQUIRING RE-OP TO REPAIR. 17 SUTURE LOTS WERE RETURNED FOR EVALUATON DUE TO THE FACT THAT THE USER FACILITY DOES NOT KNOW WHAT SUTURES ARE IN QUESTION. LOTS MAY REPRESENT WHAT WAS USED DURING SURGERY. RE-OP TO REPAIR OCCURRED 2 DAYS AFTER INITIAL C-SECTION SURGERY DUE TO WOUND DEHISCENCE. INTERNAL CONTROL NUMBER IS: 9600606-02.
REFER TO BASELINE REPORT ATTACHED TO MDR#1520348-1996-00001. CO IS SUBMITTING TTHE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
ON 10/20/93 DEVICE WAS IMPLANTED. ON 10/3/94 THREE RELAXING INCISIONS WERE MADE DUE TO PENILE CURVATURE. ON 8/14/96 THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED BECAUSE IT WAS NOT SEATED PROPERLY.
THE LEAD WAS EXPLANTED DUE TO A REPOTT OF J RETENTION WIRE FRACTRURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED APPROX 4MM PROXIMAL OF WELD SITE. THE PROX SECTION OF J STIFFENER WIRE MEASURES APPROX 73MM AND WAS RECEIVED WITH APPROX 15MM OF THE DISTAL END PROTRUDING OUT OF THE OUTER POLYURETHANE INSULATION APPROX 8MM PROXIMAL OF THE DISTAL END OF THE OUTER POLYURETHANE INSULATION WHICH SEPARATED FROM THE PROXIMAL SIDE OF THE ANODE BAND. IT APPEARS THAT APPROX 10MM OF THE J STIFFENER WIRE WAS NOT RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO APPROX 77 MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES EPOXY RESIDUE ON THE SEPARATED BOND SURFACE TO PROXIMAL SIDE OF ANODE BAND. X-RAY OF LEAD DISTALLY COFIRMS J STIFFENER WIRE FRACTURES.
THE LEAD WAS EXPLANTED DUE TO REPORT OF HIGH THRESHOLDS. THE LEAD WAS CUT AND CAPPED.
ON 5/28/96 DEVICE WAS IMPLANTED. ON 5/89 THE CYLINDERS WERE REVISED. ON 7/13/93 THE CYLINDERS AND RESERVOIR WERE REVISED. ON 8/13/96 THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
PUMP PERFORMED WITHIN SPECS. TUBING HAD A WEAR LEAK.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS-LEFT CYLINDER AND REPLACED.
THE TUBE WAS OCCLUDED BY SILICONE BURR AT 4 CM FROM THE CONNECTOR END, THEREFORE THEY COULDN'T INSERT A SUCTION CATHETER.
THE ACTUAL SAMPLE WAS RETURNED FOR EVAL AND FOUND TO BE BLOCKED WITH SILICONE. THE UNIT SHOULD HAVE BEEN DETECTED, AS THE TUBES ARE 100% INSPECTED. THE INSPECTION OPERATOR STRAIGHTENS THE SHAFT FROM THE NECK STRAP TO THE TIP USING A LAMP TO AID INSPECTION THEY THEN EXAMINE THE ID OF THE SHAFT. A FLEXIBLE ROD, NYLON NETTING AND A SOLUTION OF 70% PROPANOL AND 30 % WATER IS USED TO REMOVE ANY DEBRIS FOUND. MANUFACTURING HAS SHOWN THE RELEVANT OPERATORS THE RETURNED DEVICE AND STRESSED THE IMPORTANCE OF CONSTANT VIGILANCE WHEN WORKING WITH THE PRODUCT.
SUTURE BREAKAGE POST-OP REQUIRING RE-OP TO REPAIR. 17 SUTURE LOTS WERE RETURNED FOR EVAL DUE TO THE FACT THAT THE USER FACILITY DOES NOT KNOW WHAT SUTURES ARE IN QUESTION. LOTS MAY REPRESENT WHAT WAS USED DURING SURGERY. RE-OP TO REPAIR OCCURRED 4 DAYS AFTER INITIAL AORTIC FEMORAL BY-PASS SURGERY DUE TO WOUND DEHISCENCE. INTERNAL CONTROL NUMBER IS: 9600606-03.
A PHYSICIAN REPORTED A PT WHO RECEIVED HER FIFTH TREATMENT ON 9/10/96 INTO THE UPPER AND LOWER VERMILION AND VERMILION BORDERS AND ORAL COMMISSURES. IMMEDIATELY AFTER THE TREATMENT, THE PHYSICIAN NOTED GOOD CORRECTION AT ALL SITES, SWELLING RELATED TO THE INJECTION PROCEDURE, AND A SUBTLE, DIFFUSE VIOLACEOUS HUE AT THE RIGHT UPPER VERMILION BORDER BETWEEN THE PHILTRUM AND THE RIGHT NASOLABIAL FOLD. ONCE THE NERVE BLOCK WORE OFF, THE PT EXPERIENCED SIGNIFICANT PAIN AT THE LIP INJECTION SITES. THAT EVENING, THE VERMILION AND CUTANEOUS PART OF THE RIGHT VERMILION BORDER BECAME MILDLY DUSKY, BELIEVED TO BE POSSIBLY RELATED TO VASOCONSTRICTION FROM THE NERVE BLOCK. IT WAS GONE BY THAT NIGHT OR THE NEXT DAY. FROM 9/10/96 TO 9/13/96, THE PT HAD PERSISTENT SWELLING AND PAIN AT THE TREATMENT SITES. ON 9/13/96, THE PHYSICIAN PRESCRIBED PREDNISONE; THE PT DID NOT FILL THE PRESCRIPTION. THE NIGHT OF 9/13/96, THE PT NOTED THE ONSET OF A SUBTLE DISCOLORATION AT THE RIGHT CUTANEOUS PORTION OF THE UPPER VERMILION BORDER; ON 9/14/96, THE DISCOLORATION BECAME MORE APPARENT. THE PHYSICIAN NOTED WISHBONE-SHAPED VIOLACEOUS PURPLISH-RED STREAKS WITH INDURATION AT THE CUTANEOUS PORTION OF THE RIGHT UPPER VERMILION BORDER EXTENDING TO THE SKIN ABOVE THE BORDER APPROX 1.5CM IN LENGTH. THE STREAKS APPEARED TO ORIGINATE FROM THE VERMILION BORDER UPWARD TOWARD THE RIGHT NASOLABIAL FOLD. HE ALSO NOTED A LINEAR AREA OF DISCOLORATION AT THE TREATMENT SITE BETWEEN THE PHILTRUM AND THE RIGHT NASOLABIAL FOLD. THERE WAS NO EVIDENCE OF TISSUE BREAKDOWN OR EROSION AT THE RIGHT VERMILION BORDER. THE SWELLING AT THE LEFT UPPER LIP AND ENTIRE LOWER LIP HAD IMPROVED ABOUT 30% FROM THE TIME OF THE INITIAL TREATMENT. HE ALSO NOTED AT THE CENTER OF THE UPPER LIP INJECTION SITE ON THE MUCOSAL SIDE INFERIOR TO THE PHRENULUM, A ROUND 6 X 8 MM DUSKY AREA WITH A CRUST ABOUT 2CM AWAY FROM THE WISHBONE-SHAPED AREA OF DISCOLORATION; HE BELIEVED THIS WAS RELATED TO A VASCULAR COMPROMISE. ON 9/15/96, THE WISHBONE-SHAPED DISCOLRATION HAD DECREASED IN INTENSITY DUE TO THE CELESTONE. THE PT TOOK 60 MG PREDISONE ON 9/15/96 AND DEVELOPED EMOTIONAL LABILITY RELATED TO THE CORTISONE, NOT RELATED TO THE COLLAGEN. THE PREDNISONE DOSE WAS HELD ON 9/16/96. THE PHYSICIAN BELIEVED THE SWELLING AT THE DISCOLORED AREA BETWEEN THE PHILTRUM AND THE RIGHT NASOLABIAL FOLD CONTRIBUTED TO A PARTIAL COMPROMISE OF A BLOOD VESSEL; HE WAS NOT SURE IF THE COMPROMISE WAS RELATED TO THE PRESENCE OF THE MATERIAL, TO EDEMA RELATED TO INJECTION PROCEDURE WHICH WAS SLOW TO RESOLVE, TO A VASOSPASM, OR TO A HYPERSENSITIVITY. HE DOUBTED IT WAS RELATED TO AN OCCLUSION OF A BLOOD VESSEL.
ON 3 JULY 1997, FOLLOW UP INFO WAS RECEIVED FROM THE PHYSICIAN. THE PHYSICIAN HAD A TELEPHONE INTERVIEW WITH THE PT ON 22 JUNE 1997. ALL SYMPTOMS RESOLVED WITHIN 5-7 DAYS; THE ONLY ONGOING SYMPTOM WAS LOCAL DERMAL ATROPHY. THE PHYSICIAN'S ADDRESS HAS BEEN CHANGED.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
CYLINDER HAD A WEAR LEAK. CYLINDER DOES NOT INFLATE.
DEVICE WAS REMOVEDC FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED DUE TO PT DISSATISFACTION-DEVICE WOULD DEFLATE INTERCOURSE.
PUMP REPORTED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
THE VALVE WAS REMOVED APPROX 26 MONTHS POST IMPLANT DUE TO INSUFFICIENCY SECONDARY TO STAPHYLOCOCCI RELATED ENDOCARDITIS. THE PRODUCT WAS RETURNED FOR ANALYSIS.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED". A MEDWATCH FORM ON THIS EVENT WAS NOT REC'D FROM THE USER FACILITY. THEREFORE, MEDTRONIC COMPLETED THE FORM WITH INFO FROM THE MD. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN INFO FROM CO IS UNABLE TO COMPLETE FORM 3500A". H3 ANALYSIS: ANALYSIS IS NOT YET COMPLETE AND WILL BE SENT ON FOLLOW-UP WHEN COMPLETED.
SUTURE BREAKAGE POST-OP REQUIRING RE-OP TO REPAIR. 17 SUTURE LOTS WERE RETURNED FOR EVAL. DUE TO THE FACT THAT THE USER FACILITY DOES NOT KNOW WHAT SUTURES ARE IN QUESTION. LOTS MAY REPRESENT WHAT WAS USED DURING SURGERY. RE-OP REPAIR OCCURRED 1 DAY AFTER INITIAL EXPLORATORY LAPAROSCOPY DUE TO WOUND DEHISCENCE. INTERNAL CONTROL NUMBER IS: 9600606-04.
DEVICE WAS REMOVED FROM THE PT. NO REASON FOR THE SURGERY WAS PROVIDED.
SUTURE BREAKAGE POST-OP REQUIRING RE-OP TO REPAIR. 17 SUTURE LOTS WERE RETURNED FOR EVALUATION DUE TO THE FACT THAT THE USER FACILITY DOES NOT KNOW WHAT SUTURES ARE IN QUESTION. LOTS MAY REPRESENT WHAT WAS USED DURING SURGERY. RE-OP TO REPAIR OCCURRED, DATE UNKNOWN, AFTER INITIAL EXPLORATORY LAPAROSCOPY DUE TO WOUND DEHISCENCE. INTERNAL CONTROL NUMBER IS: 9600606-05.
H6- REPRESENTATIVE SAMPLES OF THE RETURNED PRODUCT WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND THE RESULTS OBTAINED WERE ABOVE THE CO REQUIREMENTS, WHICH ALWAYS EQUAL OR EXCEED THE MINIMUM USP REQUIREMENTS.
PT CAME INTO PHYSICIAN'S OFFICE FOR CHECK OF LEFT TESTICULAR PROSTHESIS. FOUND PROSTHESIS TO BE 1/4 (ONE FOURTH) THE SIZE THAT IT SHOULD HAVE BEEN. SCHEDULED SURGERY AND EXPLANTED PROSTHESIS WITH PROBABLE RUPTURE. POST-OP VISIT, PT OK.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. OTHER LOT/SER NO: 0388K 012.
AN ANONYMOUS SOURCE REPORTS A MALFUNCTIONING AGUS "GU SPHINCTER COMPONENT." REFERENCE FDA ACCESS #4001426.
THE DEVICE WAS REMOVED FROMN THE PT DUE TO PT DISSATISFACTION -NOT ENOUGH RIGIDITY.
CO RECEIVED A COPY OF AN AUTOPSY REPORT WHICH INDICATES THAT THE PT DIED FOLLOWING OUTLET STRUT FRACTURE OF HIS IMPLANTED HEART VALVE.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-INPUT TUBING TO LEFT CYLINDER BASE.
A PHYSICIAN REPORTED THAT THIS PT'S VALVE HAD AN OUTLET STRUT FRACTURE. THE VALVE WAS REPLACED AND THE PT SURVIVED.
PT CAME INTO PHYSICIAN'S OFFICE FOR CHECK OF LEFT TESTICULAR PROSTHESIS. FOUND PROSTHESIS TO BE 1/4 (ONE-FOURTH) THE SIZE THAT IT SHOULD HAVE BEEN. SCHEDULED SURGERY AND EXPLANTED PROSTHESIS WITH PROBABLE RUPTURE. POST-OP VISIT, PT OK.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO A NEED FOR A HIGHER PRESSURE BALLOON.
PUMP HAD OR DAMAGE. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING HAD OR DAMAGE.
INFO RECEIVED ON 10/03/96 INDICATES THE DEVICE WAS REMOVED FROM THE PT AND REPLACED ON 9/18/96.
VALVE REMOVED APPROXIMATELY 30 MONTH DUE TO PARAVALVULAR LEAK CAUSING SEVERE MITRAL REGURGITATION.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED". A MEDWATCH FORM ON THIS EVENT WAS NOT REC'D FROM THE USER FACILITY. THEREFORE, MEDTRONIC COMPLETED THE FORM WITH INFO FROM THE MD. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A". H3 ANALYSIS: ANALYSIS FOUND THE LEAFLETS TO BE INTACT, SLIGHTLY STIFF BUT FLEXIBLE; THIS DUE TO SMALL AREAS OF ABRASION ASSOCIATED WITH TRACE MINERALIZATION NOTED AT ONE COMMISURE. PRODUCT MET SPECS. ANALYSIS WAS UNABLE TO DETERMINE CAUSE OF THE REPORTED PARAVALVULAR LEAK.
NO COMPONENTS WERE REMOVED FROM THE PATIENT.
INFORMATION RECEIVED ON 8/21/96 INDICATES THE BALLOON WAS REMOVED FROM THE PATIENT AND REPLACED DUE TO RECURRING INCONTINENCE. ADDITIONAL RECEIVED ON 9/30/96 INDICATES THE ORIGINAL BALLOON WAS LEFT IN PLACE, PER DR.
DUE TO RECURRING INCONTINENCE, A TANDEM CUFF WAS IMPLANTED. NO COMPONENTS WERE REMOVED OR REPLACED.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AND REPLACED. OTHER LOT/SER NO: 9887L 009.
THE FILTER HOUSING CRACKED WHILE BEING ATTACHED TO THE INTRODUCER. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH A COMPETITOR'S SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER DELAY OR COMPLICATIONS.
THE FILTER HOUSING CRACKED WHEN ATTACHED TO THE INTRODUCER. T-ADAPTER SEPARATED BETWEEN POLYCARBONATE SLIP FIT AND VINYL BORST ADAPTER. REVIEW FOUND THAT THE LOT NUMBER FOR THE LUER LOCK RING WAS 47404-2. LOT NUMBER FOR THE CAP WAS 47406-2. THE ONLY DEVIATIONS FROM STANDARD ASSEMBLY PROCEDURES WAS THAT A WHITE HAZE APPEARED ON THE STORAGE TUBES AFTER STANDING OVERNIGHT ON THE FLOW BENCH. PARTS WERE REWORKED BY POLISHING THE EXTERIOR WITH A LINT-FREE WIPE. THIS DEVIATION IS NOT CONSIDERED TO BE A CONTRIBUTING CAUSE OF THIS COMPLAINT. MULTI-MATERIAL, MULTI-COMPONENT T-ADAPTER WAS REPLACED BY SINGLE COMPONENT Y-ADAPTER PER 510K # K950489, INSTITUTED IN 1995.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 9/7/78. BETWEEN 1993 AND 1996 PHYSICIAN REPORTS PT HAD POOR GENERAL HEALTH AND IN 1996 DEVELOPED TENDERNESS/PAIN IN THE LEFT BREAST AND AXILLA. PT HAD REMOVAL ON 4/16/96.
TEH AUS DEVICE WAS REMOVED FROM THE PT DUE TO URETHRAL EROSION.
PUMP HAD OR DAMAGE. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
INFORMATION RECEIVED ON 10/7/96 INDICATES REASON AS CUFF DOWNSIZE.
THE FILTER HOUSING CRACKED WHEN ATTACHED TO THE INTRODUCER. NO CRACKS WERE FOUND IN THE FILTER HOUSING. FILTER WAS IN STORAGE TUBE WITH BOTTOM FOUR FEET PROTRUDING FROM STORAGE TUBE. REVIEW FOUND THAT THE LOT NUMBER FOR THE Y-ADAPTER WAS ONE OF THE FOLLOWING: 61627X-1, 61665X-1, OR 61761X-1. LOT NUMBER FOR THE STORAGE TUBE WAS 57914-1. LOT NUMBER FOR THE ANTECUBITAL CATHETER WAS 60166-2. NO DEVIATIONS FROM STANDARD PROCEDURES IN ASSEMBLING THE LOT OCCURRED. FILTER HOUSING WAS NOT CRACKED.
PT ALLEGES RECEIVING A BREAST IMPLANT ON AN UNKNOWN DATE AND FROM AN UNKNOWN MFR. REPORT ALSO ALLEGES HER IMPLANT RUPTURED AND SHE HAD IT REMOVED ON AN UNKNOWN DATE.
CONCLUSION: 68 OTHER (NO DEVICE RETURNED)
THEP UMP AND CYLINDER WERE REMOVED FROM THE PT DUE TO FLUID LOSS-LEFT CYLINDER, PUMP NOT FUNCTIONING WELL AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK.
ON 12/5/88 AN AUS DEVICE WAS IMPLANTED. ON 3/21/89 THE BALLOON WAS REVISED. ON 8/22/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO ATROPHY AT THE BLADDER NECK.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE AND REPLACED. UNABLE TO OBTAIN ADD'L INFO.
RPTR ALLEGES PT RECEIVED SILICONE BREAST IMPLANTS IN 1973 OF AN UNKNOWN MFR. RPTR ALSO ALLEGES PT HAD RUPTURE; THEREFORE, HAD REMOVAL AND REPLACEMENT IN 1992 WITH SALINE DEVICES OF ANOTHER MFR.
ON 11/26/84 DEVICE WAS IMPLANTED. ON 11/9/87 THE CYLINDERS WERE REVISED. ON 8/13/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT DUE TO LEAKAGE AND A MALFUNCTION.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD TORN FABRIC AND BULGING. TUBING WAS FUNCTIONAL.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO EROSION AT CUFF.
CUFF PERFORMED WITHIN SPECIFICATIONS. PUMP WAS FUNCTIONAL.
RECEIVED CALL FROM A CLINIC NURSE CONCERNING PTS THAT HAVE HAD REPORTS OF CRAMPING, DIARRHEA, AND BLOODY DIARRHEA FOLLOWING COLONOSCOPIES. THIS IS A KNOWN REACTION TO INADEQUATE RINSING OF COLONOSCOPES FOLLOWING DISINFECTING  WITH GLUTERALDEHYDES. NO PT SPECIFIC INFO WAS AVAILABLE AT TIME OF CALL. REPEATED FOLLOW UP CALLS AND MESSAGES HAVE NOT BEEN SUCCESSFUL IN GATHERING MORE INFO. SAMPLE SOLUTION DISCARDED AS ITS EXPIRATION DATE FOLLOWING ACTIVATION HAS BEEN MET, (AT TIME OF CALLING REPORT).
DATE SENT TO FDA: 9/20/96. HAVE ATTEMPTED 5 FOLLOW UP CALLS WITH USER FACILITY WITH NO MORE ADD'L INFO. THIS IS A KNOWN DEVICE RELATED EVENT WHEN DEVICE IS NOT ADEQUATELY RINSED FROM THE COLONSCOPE.
THE CUFF REMOVED FROM THE PT DUE TO SUB-CUFF ATROPHY.
IMPLANT PLACED 10/3/96, UPPER. FAILED, WITH TEMPORARY ABUTMENT IN PLACE, ON 7/1/96. PT HAS HAD A TOTAL OF 6 IMPLANTS PLACED. ALL UPPER. A TOTAL OF 5 HAVE NOW FAILED-REF 96-402B AND 96-402C. ONE IMPLANT EACH. THE OTHER 2 WERE PREVIOUSLY REPLACED.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. PUBLISHED LIBERATURE AND CLINICAL STUDIES INDICATE THAT A 3-5% FAILURE RATE, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
PUMP WAS NOT FUNCTIONALLY TESTED. CUFF HAD A WEAR LEAK. BALLOON PERFORMED WITHIN SPECIFICATIONS.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT DUE TO FLUID LOSS A LEFT CYLINDER AND REPLACED.
RECEIVED CALL FROM A CLINIC NURSE CONCERNING PTS THAT HAVE HAD REPORTS OF CRAMPING, DIARRHEA, AND BLOODY DIARRHEA FOLLOWING COLONSCOPIES. THIS IS A KNOWN REACTON TO INADEQUATE RINSING OF COLONSCOPES FOLLOWING DISINFECTION WITH GLUTERALDEHYDES. NO PT SPECIFIC INFO WAS AVAILABLE AT TIME OF CALL. REPEATED FOLLOW-UP CALLS AND MESSAGES HAVE NOT BEEN SUCCESSFUL IN GATHERING MORE INFO.
DATE SENT FDA: 9/20/96. HAVE ATTEMPTED 5 FOLLOW UP CALLS WITH USER FACILITY WITH NO MORE ADD'L INFO. THIS IS A KNOWN DEVICE RELATED EVENT WHEN DEVICE IS NOT ADEQUATELY RINSED FROM THE COLONSCOPE.
THE PUMP AND A CONNECTOR WERE REMOVED FROM THE PT DUE TO A CONNECTOR LEAK AND REPLACED.
IMPLANT PLACED 10/3/96. IMPLANT WITH TEMPORARY ABUMENT IN PLACE, FAILED 7/1/96.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. PUBLISHED LITERATURE AND CLINICAL STUDIES INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE CAUSE OF FAILURE.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDER. OTHER LOT/SER NO: AN672 010.
PUMP PERFORMD WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A BULGE LEAK.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT HAD ERODED INTO THE URETHRA.
PUMP PERFORMED WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS.
RECEIVED CALL FROM A CLINIC NURSE CONCERNING PTS THAT HAVE HAD REPORTS OF CRAMPING, DIARRHEA, AND BLOODY DIARRHEA FOLLOWING COLONSCOPIES. THIS IS A KNOWN REACTION TO INADEQUATE RINSING OF COLONSCOPES FOLLOWING DISINFECTION WITH GLUTERALDEHYDES. NO PT SPECIFIC INFO WAS AVAILABLE AT TIME OF CALL. REPEATED FOLLOW UP CALLS AND MESSAGES HAVE NOT BEEN SUCCESSFUL IN GATHERING MORE INFO.
DATE SENT TO FDA: 9/20/96. HAVE ATTEMPTED 5 FOLLOW UP CALLS WITH USER FACILITY WITH NO MORE ADD'L INFO. THIS IS KNOWN DEVICE RELATED EVENT WHEN DEVICE IS NOT ADEQUATELY RINSED FROM THE COLONSCOPE.
INFO RECEIVED ON 8/23/96 INDICATES THE PT STATES "ONLY REAL DISSATISFACTION IS LENGHT AT THIS POINT" AND "BELIEVES THERE IS STILL SOME PROBLEM WITH GIRTH AS WELL." A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME. OTHER LOT/SER NO: BW449 005.
IMPLANT PLACED 10/3/96. IMPLANT WITH TEMPORARY ABUTMENT, FAILED 7/1/96.
THE RETURNED IMPLANT WAS EVALUATED AN FOUND TO MEET SPECS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION.
CONCLUSION: NO DEVICE RETURNEDL; NO CONCLUSION CAN BE DRAWN.
REPORT STATES INTRACAPSULAR RUPTURE OF THE LEFT BREAST IMPLANT. FREE SILICONE IN THE SOFT TISSUE SUPERIOR AND LATERAL TO THE LEFT BREAST IMPLANT PROBLABLY SECONDARY TO A SILICONE "BLEED." ALSO STATED A FEW CYSTS ANTERIORLY IN THE SUPERIOR ASPECT OF THE RIGHT BREAST.
DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. ANOTHER DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO. OTHER LOT/SER NO: 8142K 009.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK.
IN 6/96 AN AUS DEVICE WAS IMPLANTED. ON 8/20/96 THE BALLOON AND PUMP WERE REMOVED FROM THE PT AND REPLACED BECAUSE PT HAD TO DEACTIVATE HIMSELF BECAUSE HE WENT INTO RETENTION. THE DR WAS UNABLE TO REACTIVATE PUMP AND TWO LONG BLOOD CLOTS WERE FOUND IN THE PRESSURE BALLOON.
PUMP POPPET RELEASE PRESSURE EXCEEDS SPECIFICATION. ORIGINAL PRESSURE OF BALLOON UNKNOWN.
THE RETURNED IMPLANT WAS FOUND TO BE CLEAN AND TO MEET SPECS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
RECEIVED CALL FROM A CLINIC NURSE CONCERNING PTS THAT HAVE HAD REPORTS OF CRAMPING, DIARRHEA, AND BLOODY DIARRHEA FOLLOWING COLONSCOPIES. THIS A KNOWN REACTION TO INADEQUATE RINSING OF COLONSCOPES FOLLOWING DISINFECTION WITH GLUTERALDEHYDES. NO PT SPECIFIC INFO WAS AVAILABLE AT TIME OF CALL. REPEATED FOLLOW UP CALLS AND MESSAGES HAVE NOT BEEN SUCCESSFUL IN GATHERING MORE INFO.
DATE SENT TO FDA:9/20/96. HAVE ATTEMPTED 5 FOLLOW UP CALLS WITH USER FACILITY WITH NO MORE INFO. THIS IS A KNOWN DEVICE RELATED EVENT WHEN DEVICE IS NOT ADEQUATELY RINSED FROM THE COLONSCOPE.
CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
PT ALLEGES RECEIVING IMPLANTS ON 12/3/84. PT ALSO ALLEGES HAVING ANXIETY ABOUT LEAKAGE BEGINNING IN 1993. PHYSICIAN NOTE STATES ANXIETY REGARDING SILICONE.
THE CYLINDERS WERE REMOVED FROM THE PT DUE THE PAIN AND REPLACED.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION AT RESERVOIR.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECIFICATION. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS.
PUMP PERFORMED WITHIN SPECS. BALLOON PERFORMED WITHIN SPECS. CUFF HAD OR DAMAGE.
ADD'L INFO RECEIVED ON 12/11/96 INDICATES THE DATE OF SURGERY TO BE 5/3/96.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO LEFT CYLINDER-EROSION OF OUTER SHEATH AT MID-CYLINDER AND RIGHT CYLINDER-SEVERE PIN-POINT ORIFICES IN DISTAL PORTION OF CYLINDER. OTHER LOT/SER NO: 1244P 004.
PT ALLEGES RECEIVING IMPLANTS ON 10/31/91 AS REPLACEMENTS. PT ALSO ALLEGES HER "BREASTS BECAME HARD AND WERE RIDING EXTREMELY HIGH BEGINNING FROM SURGERY TO NOW"; THEREFORE, SHE HAD REMOVAL AND REPLACEMENT ON 7/10/96 WITH DEVICES OF ANOTHER MFR. PHYSICIAN NOTE STATES "BREAST HARD, TENDER, IMPLANTS RIDING VERY HIGH AND PT IS UNHAPPY WITH RESULT OF THESE IMPLANTS."
AN AUS DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. UNABLE TO OBTAIN ADD'L INFO.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECIFICATIONS. ORIGINAL BALLOON PRESSURE UNKNOWN.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO CORPORAL ANEURYSM.
CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD TORN FABRIC AND BULGING.
ON 10/01/91 AN AUS DEVICE WAS IMPLANTED. ON 11/2/91 THE BALLOON WAS REVISED. ON 8/16/96 THE CUFF WAS REMOVED FROM THE PT AND REPLACED BECAUSE IT WAS TOO LARGE.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 2/12/81. PT ALSO ALLEGES ON 7/18/96 SHE HAD SYMPTOMS OF ACHES (LEFT BREAST).
CONCLUSION: 68 OTEHR (NO DEVICE RETURNED).
PT SUSTAINED A FRACTURED HIP AND SHOULDER AS A RESULT OF FALLING FROM A PT LIFT. THE DETAILS OF THE ALLEGED MALFUNCTION ARE NOT CLEAR AND EVAL HAS NOT BEEN PERMITTED.
PT ALLEGES RECEIVING SILICONE BREAST IMPLANTS EIGHTEEN YEARS AGO (IE 1978) OF AN UNKNOWN MFR. PT ALSO ALLEGES THEY LEAKED AND SHE HAD THEM REPLACED WITH SILICONE. PT STATES SHE "NEVER HAD ANY HEALTH PROBLEMS."
ON 7/2/90 AN AUS DEVICE WAS IMPLANTED. ON 7/6/94 THE PUMP WAS REVISED. ON 8/5/94 THE PUMP WAS REPOSITIONED. ON 5/1/96 THE BALLOON AND PUMP WERE REVISED. ON 8/16/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE-FLUID LOSS, CUFF.
PUMP PERFORATED WITHIN SPECIFICATIONS. CUFF HAD A WEAR LEAK. BALLOON PERFORMED WITHIN SPECIFICATIONS.
CONCLUSION STATEMENT: RECORDS REVIEWED OF PRODUCT LOT FILE AND FOUND TO BE COMPLETE, ACCURATE, AND ACCEPTABLE. PRODUCT WAS MFR AND SOLD BY ANOTHER, THE ASSETS OF WHICH WERE PURCHASED BY CO.
WHILE SITTING IN A CHAIR AT HOME, THIS PATIENT FELT A POP IN HIS HIP AND EXPERIENCED SEVERE PAIN. ON X-RAY IN EMERGENCY DEPARTMENT A DISLOCATION OF THE LEFT HIP WAS CONFIRMED. IN SURGERY 12/6/96 THE PREVIOUSLY INSERTED 10/13/94 FEMORAL COMPONENT WAS COMPLETEDLY DISASSOCIATED AT THE STEM, TROCHANTERIC MODULE JUNCTION AND THE TROCHANTERIC MODULE AND EXTRA LONG FEMORAL HEAD WERE LYING FREE IN THE SOFT TISSUES.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE. OTHER LOT/SER NO: NI.
PT ALLEGES RECEIVING A LEFT IMPLANT ON 10/2/84. PT ALSO ALLEGES SHARP PAINS AND BURNING SENSATION FROM MIDDLE AND AROUND IMPLANT, SHARP PAIN GOING DOWN SIDE AND LEFT ARM DURING 7/96. PHYSICIAN STATES PAIN AROUND IMPLANT AND SILICONE LEAKAGE.
INFO RECEIVED ON 09/27/96 INDICATES THE PT CAUSED THE URETHRAL EROSION BY PULLING OUT A CATHETER WITH THE BALLOON STILL INFLATED.
IMPLANT SEPARATED AND REVISION SURGERY WAS PERFORMED.
EVENT OCCURRED BEFORE FINAL FDA RULING. INVESTIGATION IS NOT COMPLETE.
PLAINTIFF RECEIVED BREAST IMPLANTS ON AN UNKNOWN DATE. PLAINTIFF HAD A RUPTURE OF CO'S IMPLANT. NO OTHER SPECIFICS WERE GIVEN.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1975, AND THAT MAMMOGRAM REVEALED THAT ONE IMPLANT HAS RUPTURED. THE RUPTURE WORRIES THE PT GREATLY AND SHE WANTS HER IMPLANTS REMOVED AND REPLACED.
ALLEGED SYMPTOMS OF AUTOIMMNUNE DISEASE, SILICONE MIGRATION, HEMATOMA AND RUPTURE. REPORT IS UNSUBSTANTIATED BY A HEALTH PROFESSIONAL.
UNSUBSTANTIATED SYMPTOMS OF AUTOIMMUNE/CONNECTIVE TISSUE. UNSUBSTANTIATED SILICONE MIGRATION OF EXTRAVASATION, UNSUBSTANTIATED HEMATOMA, AND UNSUBSTANTIATED RUPTURE. THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CO THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF CO'S EVALUATION OF THE DEVICE.
PT ALLEGES RECEIVING A BREAST IMPLANT ON 3/4/85 AS A REPLACEMENT. PT ALSO ALLEGES SHE HAS SEVERE IMPACT ON HEALTH WHICH SHE SUFFERED FROM IMPLANTATION. PT HAD REMOVAL ON 5/19/92.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO TOTAL FLUID LOSS-RIGHT CYLINDER LEAK.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-EROSION, RIGHT CYLINDER AT EXIT TUBING SITE.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A FATIGUE LEAK.
RPTR ALLEGES CHILD DEVELOPED "ADDH" (ATTENTION DEFICIT DISEASE AND HYPERACTIVITY) FROM BEING BREAST FED BY HIS MOTHER WITH BREAST IMPLANTS. REF MW062810.
81 - PT (CHILD) IS NOT THE IMPLANT RECIPIENT.
DEVICE WAS REMOVED FROM THE PT DUE TO EROSION AND INFECTION. OTHER LOT/SER NO: BH847 001.
THE CYLINDERS WERE REMOVED FROM THE PT DUE TO EROSION.
ON 9/30/76 DEVICE WAS IMPLANTED. ON 5/1/77 AND 1/8/81 THE CYLINDERS WERE REVISED. ON 9/26/84 THE CYLINDERS AND PUMP WERE REVISED. ON 9/15/86 THE PUMP AND RESERVOIR WERE REVISED. ON 2/11/87 THE RESERVOIR WAS REVISED. ON 5/15/96 THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 7/25/80. PT ALSO ALLEGES CONSULTING HER DR BEGINNING IN 1985 BECAUSE OF HARDENING OF LEFT BREAST. PT SUBSEQUENTLY ALLEGES ACHING AND A LUMP BEGINNING IN 5/96. PHYSICIAN NOTE STATES LEFT IMPLANT NOW FIRMLY ENCAPSULATED AND ACHING.
THE SYSTEM WAS IMPLANTED IN 5/95 IN A 79 YR OLD MAN WHO HAS HAD A PREVIOUS STROKE, LEAVING HIM PARTIALLY PARALYZED. THE IMPLANT WAS DONE AT ANOTHER HOSP. THE PACER WAS LAST CHECKED SIX MONTHS AGO. SOME TIME IN THE LAST TWO MONTHS, THE PT HAD A SYNCOPAL EPISODE. THE PT'S HOME HEALTHCARE NURSE WITNESSED THIS EPISODE AND CLAIMS THAT THE PT HAD NO PULSE OR VITAL SIGNS.
THE PT WAS ADMITTED TO THE HOSP, WHERE NO CAUSE FOR SYNCOPE WAS FOUND. TEH PACING SYSTEM WAS NOT CHECKED AT THE TIME. THE PT HAD ANOTHER SYNCOPAL EPISODE ON 8/26/96. THE PT RECOVERED SPONTANEOUSLY AND WAS NOT SEEN BY MEDICAL PERSONNEL. SAME EVENT AS 1640319-1996-00360 AND 1640319-1996-00361.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. OTHER LOT/SER NO: 2276M 007.
A SINGLE CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION.
DEVICE WAS IMPLANTED ON 12/28/95. A CONNECTOR WAS REVISED ON 2/6/96. THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO URETHRAL PERFORATION ON 8/12/96. A MALLEABLE DEVICE WAS IMPLANTED.
THE DEVICE WAS REMOVED FROM THE PT DUE TO AN EXTENSIVE PELVIC ABSCESS. OTHER LOT/SER NO: CE017 001.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
TUBING WAS FUNCTIONAL. PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER HAD A WEAR LEAK.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -TRAUMATIC RUPTURE OF OLD PROSTHESIS-FALL ASTRIDE. OTHER LOT/SER NO: 999L 018.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-LEFT CYLINDER. OTHER LOT/SEER NO: 8035P 006.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A FATIGUE LEAK. TUBING WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS -CYLINDERS.
DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION-INADEQUATE LENGTH, FLACIDITY, AND RIGIDITY. ANOTHER DEVICE WAS IMPLANTED.
PUMP PERFORMED WITHIN SPECS. CYLINDER HAD OR DAMAGE. CYLINDER HAD A FATIGUE LEAK.
DEVICE WAS IMPLANTED ON 7/16/91. THE PUMP WAS REVISED ON 2/20/96. THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS ON 8/20/96 AND REPLACED. OTHER LOT/SER NO: BO042 007.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 11/6/84. PT'S IMPLANTS CHANGED IN SHAPE (4/16/96). PHYSICIAN STATES THE PT HAD CAPSULAR CONTRACTURE AND BILATERAL RUPTURED IMPLANTS. PT HAD REMOVAL AND REPLACEMENTS ON 7/31/96 WITH DEVICES OF ANOTHER MFR.
AN ANONYMOUS SOURCE REPORTS A MALFUNCTIONING PENILE PROSTHESIS. REFERENCE FDA ACCESS #4001427.
DEVICE WAS REMOVED FROM THE PT DUE TO EROSION. ADD'L SERIAL NUMBER: AQ331 001. ADD'L LOT NUMBER: AQ331 001.
CYLINDER STIFFENER BROKEN. CYLINDER PERFORMED WITHIN SPECS. PUMP PERFORMED WITHIN SPECS.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 4/20/89. PT DEVELOPED ITCHINESS AND PAINFUL BREAST BETWEEN 1990 AND 1996. DR STATES ANXIETY ON BEHALF OF PT AND INTERMITTENT PAIN.
A NURSE REPORTED THAT A CCPD PT DEVELOPED PERITONITIS AFTER LEAKAGE FROM THE CLAMP USED TO CLAMP OFF THE PERITONEAL DIALYSIS TUBING. THE PT WAS TREATED SUCCESSFULLY WITH ANTIBIOTICS.
ACTUAL COMPLAINT SAMPLE NOT RETURNED. PT RETURNED OTHER UNUSED SAMPLES. DIMENSIONAL ANALYSIS SHOWED ALL CLAMPS TO BE WITHIN SPECIFICATION AND NONE LEAKED WHEN TESTED.
PT IS PLANNING TO HAVE HIS DEVICE REMOVED-ALLEGES "PROBLEMS SINCE DAY ONE" AND PAIN EVER SINCE IMPLANTATION.
IN JANUARY OF 1995, THE INDIVIDUAL ALLEGEDLY WAS DIAGNOSED WITH LATEX HYPERSENSITIVITY TYPE I.
SMITH & NEPHEW IS SUBMITTING THIS REPORT TO COMPLY WITH 21 CFR 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. TIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT.
PT ALLEGES RECEIVING A LEFT BREAST IMPLANT ON 9/22/82. PT ALSO ALLEGES SEEING HER DR ON 3/19/96 BECAUSE HER IMPLANT HAD MOVED UP TOWARDS HER COLLARBONE AND APPEARED TO HAVE GONE HARD, ALSO STRETCHING SKIN AS IT MOVED UP. PHYSICIAN NOTE STATES EXTENSIVE CONTRACTURE, PSYCHOLOGICAL PROBLEM AND WANTS REMOVAL.
THE SET WAS BLOCKED DURING DELIVERY OF DEXTROSE. AS A RESULT, THE PT'S BLOOD SUGAR LEVEL DROPPED REQUIRING A DEXTROSE BOLUS.
ONE UNIT RETURNED FOR EVALUATION. EXAMINATION OF THE UNIT WAS UNABLE TO VERIFY ISSUE. LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 7/31/75. PT ALSO ALLEGES TWO YEARS AGO (IE, 1994) SHE HAD SUDDEN SEVERE CHEST AND LEFT SHOULDER AND ARM PAIN, WHICH SUBSIDED WITHIN FIVE HRS. LAST YEAR SHE HAD LEFT BREAST PAIN OF THREE TO FOUR WEEK DURATION. ON 6/30/96, SHE HAD SEVERE MUSCLE SPASMS OF HER LEFT SHOULDER/ARM. PT ALLEGES CAUSE OF PAIN RELATED TO SEVERE LEFT CAPSULAR CONTRACTURE AND THE ACQUIRED CHEST DEFORMITY. PT HAD REMOVAL AND REPLACEMENT ON 8/19/96, WITH DEVICES OF ANOTHER MFR. THE IMPLANTS WERE NOT RUPTURED.
THE REPORTER STATED THAT HER HUSBAND, A 66 YEAR OLD PT DIAGNOSED AS A TYPE II DIABETIC 37 YRS AGO, WAS HOSPITALIZED AND TREATED WITH INSULIN AND IV MEDICATION FOR HIGH BLOOD SUGAR (800 BY HOSP LABS). THE PT'S DEVICE READ 154(TIME AND TREATMENT BETWEEN THE TWO READINGS WAS NOT REPORTED). THE PT HAD NOT TAKEN HIS MEDICATION BECAUSE OF THE CO DEVICE RESULT.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 10/89. PT ALSO ALLEGES HAVING THE POSSIBILITY OF SILICONE IMPLANTS BEING RUPTURED. PT IS IN THE PROCESS OF SEEING HER DR AND HAVING HER IMPLANTS REPLACED.
H3 - ADDITIONAL INFORMATION RECEIVED CONFIRMS DEVICES WERE NOT MANUFACTURED BY CO. THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED PURSUANT TO 21 CFR, PART 803. THE REPORT TRANSMITS ALLEGATIONS AND THERE IS NOT BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFORMATION IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OR OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
APPROXIMATELY 20 MIN. INTO TREATMENT, THE PT BECAME DYSPENIC. THE PT'S RR WAS GREATER THAN 20 AND THE BP WAS ELEVATED 180/110. THE PT COMPLAINED OF FEELING HOT BUT WAS AFEBRILE AND WAS REINFUSED PER THE NEPHROLOGIST. SYMPTOMS WERE RESOLVED AFTER REINFUSION. ESTIMATED BLOOD LOSS WAS GREATER THAN 100CC BLOOD CULTURES WERE DONE AND A CHANGE IN DIALYZER WAS PRESCRIBED.
THE RETURNED UNIT FROM THE SAME LOT NUMBER WAS RETURNED TO THE FACTORY AND TESTED FOR PYGOGENS, ACUTE SYSTEMIC TOXICITY, INTRACUTANEOUS TOXICITY AND HEMOLYSIS; NO ABNORMALITY WAS OBSERVED. STERILITY AND PYROGEN TESTS ARE ROUTINELY TESTED PRIOR TO SHIPMENT; THE RECORDS FOR THIS LOT WERE REVIEWED AND NO ABNORMALITY WAS OBSERVED. THE CAUSE OF THE INCIDENT CANNOT BE DETERMINED.
THE MALE LUER SLIP DISCONNECTED FROM ANOTHER MANUFACTURER'S CATHETER. ALLOWING A LOSS OF FLUIDS AND REQUIRING A TRANSFUSION. THE REPORTER INDICATED THAT THIS HAD OCCURRED ON ONE OTHER OCCASION BUT DID NOT PROVIDE SPECIFIC DETAILS.
CUSTOMER INDICATED SAMPLES HAD BEEN DISCARDED. LOT HISTORIES WERE REMOVED AND WERE FOUND TO BE ACCEPTABLE.
PT ALLEGES RECEIVING BREAST IMPLANTS TWENTY YEARS AGO (IE 1976). PT REPORTED SIX DAYS AFTER MAMMOGRAM (DATE UNKNOWN) SHE WOKE UP WITH PAIN IN HER BREAST, IT WAS CAVED IN AND SUBSEQUENTLY HAD A HUGE BLOOD CLOT IN LEFT IMPLANT BETWEEN IMPLANT AND SCAR TISSUE. SHE NEVER HAD ANY PROBLEM UNTIL THIS LAST MAMMOGRAM.
PT ALLEGES RECEIVING BREAST IMPLANTS ON AN UNKNOWN DATE AND OF AN UNKNOWN MFR. PT ALSO ALLEGES SHE IS HAVING PROBLEMS AND NEEDS TO HAVE REMOVAL; HOWEVER, NO OTHER SPECIFICS WERE GIVEN.
WHILE BRUSHING HER TEETH, CONSUMER FELT A CUT IN THE MUCOSA OF HER MOUTH. SHE ALLEGES THAT A PIECE OF PLASTIC WAS PROTRUDING OUT FROM THE PRODUCT. CONSUMER IS DIABETIC AND WENT TO MD WHO TREATED HER WITH ANTIBIOTICS.
EVALUATION SUMMARY: SAMPLE WAS NOT RECEIVED. TOOTHBRUSH CODING WAS NOT PROVIDED BY THE CUSTOMER FOR RETAIN SAMPLES AND BATCH RECORDS TRACEABILITY. NO TREND HAS BEEN OBSERVED DURING THE LAST 24 MONTHS.
PT ALLEGES RECEIVING A BREAST IMPLANT IN 1980 OF AN UNKNOWN MFR. PT REPORTS MEDICAL PROBLEMS INCLUDING STROKES RELATED TO STRESS, UNEXPLAINED BRUISING, WEAKENING OF MUSCLE AROUND THE IMPLANT AND HURTING FOR A LONG TIME. HER IMPLANT WAS REMOVED ON 5/9/94.
THE SPRING WIRE GUIDE WAS USED FOR A CATHETER EXCHANGE PROCEDURE. DURING A ROUTINE CXR ON 8/13/96, THE SHADOW OF THE WIRE WAS SEEN IN THE PULMONARY ARTERY. AFTER AN UNSUCCESSFUL ATTEMPT TO REMOVE THE WIRE USING A BUCKET, OPEN CHEST SURGERY WAS PERFORMED AND THE WIRE WAS REMOVED. THERE WERE NO ADD'L PT COMPLICATIONS.
PT ALLEGES RECEVING A BREAST IMPLANT ON AN UNKNOWN DATE AND OF AN UNKNOWN MFR. PT REPORTS LEAKING IMPLANT IS CAUSING INFLAMMATION AND SEVERE PAIN AND THIS IS EMOTIONALLY VERY DIFFICULT. PT ALSO REPORTS SHE WAS ADVISED TO HAVE IMPLANT REMOVED.
TYPE I DIABETIC HAD BEEN OBTAINING BLOOD GLUCOSE VALUES FROM THE DEVICE WHICH WERE GREATER THAN 200 MG/DL. ON DAY OF EVENT, DIABETIC BEGAN "ACTING STRANGE". SO FAMILY CONTACTED MEDICS. MEDICS DETERMINED BLOOD GLUCOSE TO BE 40 MG/DL BY AN UNKNOWN METHOD. DIABETIC WAS TREATED WITH INTRAVENOUS GLUCOSE. QUALITY CONTROL SOLUTIONS WERE OUTSIDE OF RANGE INDICATING THAT THE TEST STRIPS WERE DAMAGED BY IMPROPER STORAGE.
EVALUATION SUMMARY: THE SUBJECT DEVICE WAS EXAMINED BY A THIRD PARTY ENGINEERING GROUP IN THE PRESENCE OF AN ENGINEERING REPRESENTATIVE FROM THE MFR. EVALUATION OF THE DISPOSABLE LOADING UNIT DETERMINED THAT THE COMPONENT WHICH ADVANCES THE STAPLES WAS MALASSEMBLED. IT WAS NOTED UPON FURTHER INSPECTION THAT THIS DISPOSABLE LOADING UNIT WAS NOT THE ORIGINAL DISPOSABLE LOADING UNIT PROVIDED WITH THE STAPLER BY THE MFR BUT A RELOAD (INSTALLED BY THE USER) OF A DISTINCT, UNSPECIFIED, PRODUCTION LOT. THE STAPLER DID NOT EXHIBIT ANY ABNORMALITIES. CORRECTIVE ACTION HAS BEEN IMPLEMENTED WHICH ADDRESSED THIS CONDITION SINCE THE MFR DATE OF THE DISPOSABLE LOADING UNIT.
THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE BROKE AND THE WOUND DEHISCED POST-OPERATIVELY. THE HOSP HAS REPORTED NO FURTHER INFO.
9/20/96 MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT. THE SAMPLES RETURNED DID APPEAR TO BE BROKEN BUT DID NOT PROVIDE SUFFICIENT EVIDENCE TO ASSIST CO IN DETERMINING THE CAUSE OF THE DIFFICULTY REPORTED.
AN UNSUBSTANTIATED LEGAL COMPLAINT WAS RECEIVED WHICH ALLEGES THAT THE PLAINTIFF RECEIVED BREAST IMPLANTS AND NOW SUFFERS A WIDE VARIETY OF "DISABLING DISEASES".
AS THE PROSTHESES WERE NOT RETURNED, NO PHYSICAL EVALUATION WAS POSSIBLE, AND NO CONCLUSION COULD BE DRAWN. THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CUI CORPORATION THAT THE REPORT OR INFO HEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. REPORTS ARE BASED ON INFO SUPPLIED TO CUI CORP WITHOUT OUR INDEPENDENT VERIFICATION AS TO ITS ACCURACY OR COMPLETENESS. IT IS UNDERSTOOD THAT THE INFO MAY NOT REPRESENT FACT AFTER INVESTIGATION. CO'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OR REPORTING. FILING A MDR PURSUANT TO 21 CFR, PART 803.16 DOES NOT CONSTITUTE AN ADMISSION BY CO THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CASUAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE NECESSARILY AN ACCURATE REFLECTION OF THE RESULTS AND CONCLUSIONS OF THE DEVICE EVALUATION.
AN UNSUBSTANTIATED LEGAL COMPLAINT WAS RECEIVED WHICH ALLEGES THAT THE PLAINTIFF RECEIVED A BREAST IMPLANT AND CLAIMS TO HAVE SUFFERED INJURIES AS A RESULT OF HAVING BEEN IMPLANTED WITH BREAST IMPLANTS.
AS THE PROSTHESIS WAS NOT RETURNED, NO PHYSICAL EVALUATION WAS POSSIBLE, AND NO CONCLUSION COULD BE DRAWN. THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CUI CORP. THAT THE REPORT OR INFO THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. REPORTS ARE BASED ON INFO SUPPLIED TO CUI CORP. WITHOUT OUR INDEPENDENT VERIFICATION AS TO ITS ACCURACY OR COMPLETENESS. IT IS UNDERSTOOD THAT THE INFO MAY NOT REPRESENT FACT AFTER INVESTIGATION. CO'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. FILING A MDR PURSUANT TO 21 CFR, PART 803.16 DOES NOT CONSTITUTE AN ADMISSION BY CO THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH  THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE NECESSARILY AN ACCURATE REFLECTION OF THE RESULTS AND CONCLUSIONS OF THE DEVICE EVALUATION.
REFERENCE 1640319-1996-0359. THE SYSTEM WAS IMPLANTED IN 5/95 IN A 79 YR OLD MAN WHO HAS HAD A PREVIOUS STROKE, LEAVING HIM PARTIALLY PARALYZED. THE IMPLANT WAS DONE AT ANOTHER HOSP. THE PACER WAS LAST CHECKED SIX MONTHS AGO. SOME TIME IN THE LAST TWO MONTHS, THE PT HAD A SYNCOPAL EPISODE. THE PT'S HEALTHCARE NURSE, WITNESSED THIS EPISODE, AND CLAIMS THAT THE PT HAD NO PULSE OR VITAL SIGNS.
THE PT WAS ADMITTED TO THE HOSP, WHERE NO CAUSE FOR SYNCOPE WAS FOUND. THE PACING SYSTEM WAS NOT CHECKED AT THE TIME. THE PT HAD ANOTHER SYNCOPAL EPISODE ON 8/26/96. THE PT RECOVERED SPONTANEOUSLY AND WAS NOT SEEN BY MEDICAL PERSONNEL. SAME EVENT AS 1640319-1996-0059 AND 1640319-1996-00361.
RN STATES TOOK SNARE OUT OF PKG. PLACED IT DOWN ANOTHER CO'S SCOPE INTO THE COLON (UNK EXACT LOCATION) FOR REMOVAL OF A LARGE POLYP. USING ANOTHER CO'S CAUTERY UNIT WITH THEIR NORMAL SETTINGS AT 0CUT/3COAG, WAS UNABLE TO CUT THRU POLYP (SESSILE). MD TURNED UP THE SETTINGS TO 5COAG & CUT THRU.
#10 COULD NOT EVALUATE AS PRODUCT NOT RETURNED. #11 ALL INFO. IN SEC. F HAS BEEN FILLED IN BY CO BECAUSE THE USER FACILITY DID NOT PROVIDE.
CONSUMER REPORTED THAT HER SON HAD A FEVER REGISTERING 103 F ON THE THERMOMETER. THE MOTHER ADMINISTERED TYLENOL AND USED A COOL CLOTH TO COOL HIM DOWN. THE TEMPERATURE THEN REGISTERED 102F. NEXT, SHE BATHED THE CHILD AND TOOK HIS TEMPERATURE AGAIN, AT WHICH TIME SHE OBTAINED A READING OF 102F. THE CHILD THEN HAD A SEIZURE AND WAS TAKEN TO THE EMERGENCY ROOM. IN THE EMERGENCY ROOM, THE CARE PROVIDER OBTAINED AN AXILLARY TEMPERATURE READING OF 104.4F WHEN USING A DIGITAL THERMOMETER. THE MOTHER ESTIMATED THE ELAPSED TIME BETWEEN HER READING OF 102F AND THE READING TAKEN IN THE EMERGENCY ROOM TO BE 40 MINUTES.
DURING THE VISUAL INSPECTION OF THE RETURNED UNIT, IT WAS NOTICED THAT THE SURFACE AND EDGES OF THE LENS FILTER WHICH HAD BEEN USED DISPLAYED A WAXY RESIDUE. THE MEMBRANE ITSELF WAS ALSO DIRTY, WITH A GREASY STREAK RUNNING ACROSS THE MEMBRANE. LINT PARTICLES WERE ALSO PRESENT. THE ENTIRE UNIT, INCLUDING THE STORAGE CASE, WAS UNCLEAN AND POORLY MAINTAINED. WHEN CO TESTED THE THERMOMETER IN THE CONDITION IT WAS RECEIVED, LOW READINGS WERE CONFIRMED. THESE LOW READINGS WERE APPROX 1.4F LOWER THAN THE VALUE STATED IN THE SPECIFICATIONS. AFTER CLEANING THE MEMBRANE AND CHANGING THE LENS FILTER, THE UNIT GAVE TEMPERATURE READINGS WHICH WERE WITHIN SPECIFICATIONS FOR THIS PRODUCT. THE FOREGOING INFO IS BEING PROVIDED PURSUANT OF THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING RULE. THE ACCURACY AND COMPLETENESS OF MUCH OF THE INFO CONTAINED IN THIS REPORT HAS NOT BEEN VERIFIED. ACCORDINGLY, IT MAY BE DETERMINED THAT THE INFO CONTAINED IN THIS REPORT IS NOT, IN PART OR WHOLE, FACTUAL OR ACCURATE. IN ANY CASE, THE REPORTING OF THE INFO CONTAINED HEREIN DOES NOT REFLECT AND SHOULD NOT BE CONSTRUED TO REFLECT A CONCLUSION, DETERMINATION, OR ADMISSION BY THERMOSCAN THAT THERE EXISTS ANY CAUSAL RELATIONSHIP BETWEEN THE COMPLAINT REPORTED IN THIS SUBMISSION AND THE USE OF THE THERMOSCAN PRODUCT, OR THAT THE PRODUCT IS IN ANY WAY DEFECTIVE.
PT UNDERWENT PLACEMENT OF A LEFT TOTAL KNEE PROSTHESIS DURING 10/90 WITH SUBSEQUENT REVISION IN 1991. POSTOPERATIVELY, HIS KNEE REMAINED PAINFUL. HE HAD A HEMARTHROSIS. ASPIRATION OF THE KNEE WAS PERFORMED AND CULTURES WERE REPORTED AS NEGATIVE.  DURING DECEMBER, THE KNEE WAS STIFF AND PAINFUL AND A MANIPULATION WAS PERFORMED. DURING MAY 1995, OPEN DEBRIDEMENT OF THE KNEE WAS PERFORMED. THE SYNOVIUM WAS INFECTED AND THE PROSTHESIS WAS REMOVED. I.V. ANTIBIOTICS WERE ADMINISTERED. THE JOINT WAS DEBRIDED AGAIN AND A RECONSTRUCTIVE POSTERIOR STABILIZED KNEE WAS INSERTED BY ANOTHER SURGEON. NO SIGNS OF INFECTION DEVELOPED FOLLOWING THAT PROCEDURE. HE PRESENTED TO HOSPITAL WITH COMPLAINTS OF PAIN WITH ANY TYPE OF MOVEMENT OF KNEE AND AMBULATING WITH A LIMP. HE REPORTED PAIN MEDICATIONS DID NOT RELIEVE HIS PAIN. A BONE SCAN WAS OBTAINED PRIOR TO ADMISSION OF THE PT TO THE HOSPITAL WITH REVEALED LOOSENING OF THE PROSTHESIS. THE PT WAS ADMITTED TO THE HOSP FOR REVISION OF THE PROSTHETIC DEVICE. IT WAS NOTED AT THE TIME OF SURGERY THAT THE IMPLANTS APPEARED TO BE "MALALIGNED". THE QUESTION OF POSSIBLE USER ERROR WAS RAISED. THE TIBIAL COMPONENT WAS NOTED TO BE QUITE LOOSE AND WAS "NOT EVEN ALL THE WAY DOWN ON THE TIBIAL SURFACE". THE TIBIAL COMPONENT WAS INTERNALLY ROTATED. A FROZEN SECTION WAS OBTAINED INTRAOPERATIVELY AND NO SIGNS OF INFECTION WERE FOUND. THE UNDERSURFACE OF THE PATELLA WAS FOUND TO BE VERY WORN INTRAOPERTIVELY. DEVICE NUMBERS FOR THIS DEVICE ARE NOT AVAILABLE SINCE THE PT'S SURGERY WAS PERFORMED AT ANOTHER FACILITY.
REFERENCE 1640319-1996-0359. THE SYSTEM WAS IMPLANTED IN 5/95 IN A 79 YR OLD MAN WHO HAS HAD A PREVIOUS STROKE, LEAVING HIM PARTIALLY PARALYZED. THE IMPLANT WAS DONE AT ANOTHER HOSP. THE PACER WAS LAST CHECKED SIX MONTHS AGO. SOME TIME IN THE LAST TWO MONTHS, THE PT HAD A SYNCOPAL EPISODE. THE PT'S HEALTHCARE NURSE WITNESSED THIS EPISODE AND CLAIMS THAT THE PT HAD NO PULSE OR VITAL SIGNS.
THE PT WAS ADMITTED TO THE HOSP, WHERE NO CAUSE FOR SYNCOPE WAS FOUND. THE PACING SYSTEM WAS NOT CHECKED AT THE TIME. THE PT HAD ANOTHER SYNCOPAL EPISODE ON 8/26/96. THE PT RECOVERED SPONTANEOUSLY AND WAS NOT SEEN BY MEDICAL PERSONNEL. SAME EVENT AS 1640319-1996-00359 AND 1640319-1996-00360.
THE PT WAS SCHEDULED FOR A LEAD REVISION ON 9/12/96 DUE TO PACING LEAD IMPEDANCE PROBLEMS WITH ANOTHER CO'S PACING LEAD WHICH HAD BEEN IMPLANTED ON 7/22/92. THE PACING LEAD IMPEDANCE VARIED BETWEEN 900 OHMS AND 1300 OHMS. THE LEAD WAS CAPPED AND LEFT IN THE PT. AN ATTEMPT WAS MADE TO IMPLANT A NEW LEAD. THE NEW LEAD WHEN CONNECTED TO THE DEFIBRILLATOR GAVE IMPEDANCE VALUES OF LESS THAN 100 OHMS AND A FLATLINE ON THE REAL-TIME ELECTROGRAMS. REPROGRAMMING OF THE DEVICE DID NOT ELIMINATE THE IMPEDANCE PROBLEM. THE PHYSICIAN EXPLANTED THE DEVICES.
NURSE STATES PEG WAS IN PLACE 2 1/2YRS AND WHEN PHYSICIAN WENT TO TRACTION REMOVE THE PEG, THE DOME SEPARATED FROM THE SHAFT. MD ENDOSCOPICALLY RETRIEVED DOME USING UNK. DEVICE W/O ANY PT. COMPLICATION. NO OTHER DEVICE WAS PLACED. PT FED ORALLY. DISCUSSED W/SALES REP LENGTH OF TIME IN PLACE.
#10 COULD NOT EVALUATE AS PRODUCT NOT RETURNED. #11 ALL INFO IN SEC F HAS BEEN FILLED IN BY BIPD FOR THE USER FACILITY.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA PROCEDURE. REPORTEDLY, THE TROCAR PUNCTURED THE BOWEL AND THE AORTA. A TRANSFUSION WAS PERFORMED. THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY AND A VASCULAR SURGEON WAS CALLED IN TO REPAIR THE VESSEL. THE HOSP HAS REPORTED THE PT'S STATUS IS SATISFACTORY AT THIS TIME. THE PT WAS A VERY SMALL THIN MAN. DATE DEVICE EXPIRES: 6/20/2001.
9/19/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT. THE HOSP DID NOT RELEASE THE DEVICE FOR CO'S EVALUATION.
THE CUSTOMER INITIALLY CONTACTED CO ON 6/10/96 VIA THE CUSTOMER SERVICE 1-800 NUMBER AND COMPLAINED THAT SHE WAS OBTAINING LOW READINGS. NO MENTION OF HER CHILD EXPERIENCING A FEBRILE SEIZURE WAS MADE. WHEN SHE SENT THE UNIT BACK TO CO, SHE ENCLOSED A NOTE REPORTING THE FACT THAT HER CHILD HAD EXPERIENCED A SEIZURE. THE CONSUMER'S LETTER STATES THAT HER SON IS PRONE TO FEBRILLE SEIZURES. WHEN USING THE THERMOMETER THE EVENING PRECEDING THE SEIZURE, SHE OBTAINED A READING OF 101.9F ON HER SON. SHE CONTINUED MONITORING HIM, AND STATES HIS TEMPERATURE REMAINED AROUND 101.9F THROUGH THE NIGHT. THE NEXT MORNING, HIS TEMPERATURE REGISTERED 98.7F ON THE THERMOMETER. ABOUT 20 MINUTES AFTER OBTAINING THIS READING, HER SON HAD A SEIZURE. SHORTLY AFTER THE SEIZURE, SHE TOOK HER SON'S TEMPERATURE USING A DIGITAL THERMOMETER AND OBTAINED A READING OF 103 F. NO MEDICAL INTERVENTION WAS SOUGHT.
WITH RESPECT TO THE "CONCLUSION" CODE USED IN SECTION H6 OF THE REPORT, THE RETURNED DEVICE WAS INADVERTENTLY DISCARDED BEFORE ALL THE TESTING COULD BE COMPLETED AND EVALUATED.
CREASE/FOLDING OF IMPLANT AND PAIN. THE POTENTIAL FOR THE ABOVE-NOTED EVENTS(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16 THIS REPORT AND INFO DOES NOT NECCESSARILY REFLECT A CONCLUSION BY CO THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, TEH REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF CO'S EVALUATION OF THE DEVICE.
THE DEVICE WAS APPLIED DURING A PNEUMONECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. A PORTION OF THE PULMONARY VEIN WAS RESECTED. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
9/19/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT TO FDA.
PT WAS RE-ADMITTED ON 8/4/96 DUE TO SWELLING OF THE RIGHT KNEE AND FEVER. PT WAS DISCHARGED ON 8/5/96 AND TREATED WITH ANTIBIOTICS. THE INCIDENT OCCURRED 23 DAYS AFTER KNEE ARTHROSCOPY WITH MENISCAL REPAIR SURGERY. INTERNAL CONTROL NUMBER IS: PI 9600572-00.
SAMPLE OF MATERIAL IN QUESTION CURRENTLY UNDERGOING STERILITY TESTING. UPON COMPLETION OF TESTING, SUPLEMENT WILL BE PROVIDED WITH APPLICABLE EVALUATION CODES.
H6- FINISHED GOOD STERILITY TESTING ON THE SAMPLES OF THE ABOVE, STATED PRODUCT CODE AND BATCH NUMBER RETURNED WAS COMPLETED WITH ALL STERILE RESULTS.
DEVICE WAS PLACED FOR BOLUS INFUSION OF IMFED, 9/10/96. WHILE REMOVING CATHETER, 9/14/96. IT BROKE OFF & EMBOLISED. PT WAS TAKEN TO LOCAL HOSP, WHERE THE EMBOLISED PIECE WAS REMOVED.
CATHETER WAS DISCARDED. SINCE THERE WAS NO RESISTANCE FELT DURING ITS REMOVAL, IT WAS NOT FIXED TO THE VESSEL WALL BY FIBRIN BUILD-UP. A 1.5 CC SYRINGE WAS USED TO BOLUS THE IMFED FOLLOWED BY THE 3CC FOR FLUSHING. BOTH THERE SYRINGES HAVE THE POTENTIAL TO CAUSE A RUPTURE DUE TO EXCESS PRESSURE BEING GENERATED. 5CC OR 10CC SYRINGES SHOULD BE USED.
THE DEVICE WAS USED DURING A LOBECTOMY. THE "FIRING KNOB STOPPED WHILE FIRING THE INSTRUMENT". THE INCISION HAD TO BE EXTENDED.
A1,2,3,4:B6,7:D10: INFORMATION NOT PROVIDED BY AFFILIATE.G3: USER FACILITY WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH.BASED ON THE INFORMATION RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT WAS CONCLUDED THAT THE SAFETY MECHANISM OF THE CARTRIDGE WAS ACTIVATED PRIOR TO ACTUALLY FIRING THE INSTRUMENT. IT IS POSSIBLE THAT AN INADVERTENT MOVEMENT OF THE FIRING KNOB MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THIS IS EVIDENCE BY THE PROXIMAL DRIVERS BEING IN THE UP POSITION. IT SHOULD BE NOTED THAT THE CARTRIDGE IS DESIGNED TO LOCK-OUT IF ANY STAPLES HAVE BEEN FIRED FROM THE CARTRIDGE. ONCE THE CARTRIDGE AND THE INSTRUMENT WAS FIRED WITH THE CARTRIDGE. IT FIRED AND FORMED THE REMAINING STAPLES AS DESIGNED ACROSS THE ENTIRE STAPLE LINE WITH NO DIFFICULTIES NOTED. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
DEVICES REMOVED DUE TO LOOSENING. SURGEON INDICATED THE DEVICES APPEARED TO BE "MALALIGNED" AND THAT THE QUESTION OF USER ERROR WAS RAISED.
EVAL CODES FOR SECTION H6: 86-100 DEVICES WERE NOT RETURNED FOR EVAL. THEREFORE NO CONCLUSION COULD BE MADE. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
PT ALLEGES, "I AM A FEMALE PERSON WHO WAS APPROX 30 YEARS OLD WHEN I HAD TWO SILICONE IMPLANTS IMPLANTED IN MY BREAST AREA. BECAUSE OF PAIN (I HAVE ALSO BEEN EXTREMELY TIRED) I WAS SENT FOR AN MRI AND HAVE FOUND THAT MY LEFT BREAST IMPLANT HAS RUPTURED. AS THEY DID NOT DO A RIGHT BREAST MRI, WE ARE NOT SURE ABOUT THAT BREAST. I HAVE BEEN TOLD THAT BECAUSE OF CAPSULING, THE SILICONE IS STILL PROBABLY IN MY BREAST AREA." RPTR FURTHER STATES, "AGAIN, AS MY IMPLANTS HAVE RUPTURED, I MUST DO SOMETHING IMMEDIATELY." REF MEDWATCH 1009660.
NO ADD'L FOLLOW-UP CAN BE DONE ON THIS REPORT. THE RPTR IS ANONYMOUS.
THE DEVICE WAS USED DURING A BOWEL PROCEDURE. THE SURGEON HAD TO BRING TWO PTS BACK TO OR FOR ANASTOMOTIC LEAKS-PATIENTS WERE OK SUBSEQUENTLY. STANDARD BOWEL ANASTOMOSIS. THE TWO INSTRUMENT AFFECTED WERE DISCARDED BY HOSP, THREE SEALED INSTRUMENTS FROM SAME LOT BEING RETURNED FOR EVAL.
THE TUBING WAS SET UP AS USUAL, THE PT HAD A SEVERE HEMOTHORAX AND WAS NOT RECOVERING AT ALL. HIS CONDITION WAS GETTING WORSE SO HE WAS TRANSFERED TO THE ICU IN A VERY BAD CONDITION. THE STAFF FINALLY REALIZED THAT SOMETHING WAS BLOCKING THE TUBING, IN FACT, A "GREEN CAP" WAS INSERTED INTO THE TUBING AVOIDING ALL DRAINAGE. THE TUBING WAS THEN IMMEDIATELY CHANGED AND THE PT RECOVERED.
A 3/4" SECTION OF TUBING WAS RETURNED, WHICH CONTAINED A GREEN CAP. THE CAP WAS A MANOMETER TUBE PLUG USED IN AN EMERSON PUMP ADAPTER. PRODUCT NAMED IN THE COMPLAINT DOES NOT CONTAIN A MANOMETER, THEREFORE NO CAP IS INCLUDED. LOT HISTORY WAS REVIEWED AND NO CAPS ARE USED IN TESTING. THERE WERE NO EMERSON PUMPS PRODUCED WITHIN THREE MONTHS OF THE PRODUCTION OF THIS LOT OF DRAINAGE SETS, WHICH RULES OUT THE POSSIBILITY OF A MFG ERROR. CO HAS RECEIVED NO SIMILAR COMPLAINTS. THE REPORTING HOSPITAL PURCHASES EMERSON PUMP ADAPTORS. EVIDENCE SUGGESTS THERE MAY HAVE BEEN A MIX UP AT THE HOSPITAL. USER ERROR MAY HAVE CONTRIBUTED TO THE EVENT.
THE UNIT SUFFERED SIGNIFICANT DAMAGE AS A RESULT OF AN INTERNAL ELECTRICAL SHORT. A SIMILAR EVENT COULD RESULT IN A FIRE WITHIN THE PT VICINITY. THE SHORT WAS CAUSED BY WATER DAMAGE, OR THE DRIP PAN COMING IN CONTACT WITH THE PCB BOARD.
THE DEVICE WAS USED DURING A BOWEL PROCEDURE. "SURGEON HAD TO BRING A PT BACK TO OR FOR ANASTOMOTIC LEAKS PT WAS OK SUBSEQUENTLY. STANDARD BOWEL ANASTOMOSIS. THE INSTRUMENT AFFECTED WAS DISCARDED BY HOSP. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
ON 8/26/96, THE MFR'S SENIOR SALES SPECIALIST (WHO IS ALSO A NURSE) WAS PRESENT IN THE OPERATING ROOM FOR PLACEMENT OF THE MFR'S DEVICE FOR INFUSION OF DURAMORPH FOR THIS PT WITH INTRACTABLE PAIN. THE MFR'S EPIDURAL CATHETER WAS BEING PLACED INTRATHECALLY BY THE SURGEON (NOTE: INTRATHECAL PLACEMENT OF THE DEVICE IS NOT A MFR'S INDICATION FOR THE DEVICE'S INTENDED USE); HOWEVER, UPON PLACEMENT THE EPIDURAL CATHETER WAS SHEARED AND CUT ACCIDENTALLY WHEN THE SURGEON WAS ATTEMPTING TO PULL OUT THE DEVICE GUIDEWIRE AND THE TOUHY NEEDLE SHEARED OFF THE EPIDURAL CATHETER. THE SURGEON REMOVED THE TWO PIECES OF EPIDURAL CATHETER AND INSERTED A NEW EPIDURAL CATHETER IN THE INTRATHECAL SPACE. THE MFR'S SENIOR SALES SPECIALIST INFORMED THE SURGEON TO REMOVE THE TOUHY NEEDLE PRIOR TO PULLING BACK ON THE DEVICE GUIDEWIRE, THE SURGEON WAS AWARE OF THIS. PER THE SURGEON, NO FURTHER FOLLOW-UP IS NECESSARY REGARDING THIS INCIDENT.
ON 9/11/96, THE PT WAS RETURNED TO THE OPERATING ROOM, (MDR: 1291454-1996-00439) WITH PURULENT DRAINAGE FROM AN INCISION AT THE LUMBAR REGION OF THE SPINE FROM THE DEVICE IMPLANT SURGERY PERFORMED ON 8/26/96. THE IMPLANTING SURGEON WAS ON VACATION. A NEUROSURGEON AND THE IMPLANTING SURGEON'S PARTNER/ASSOCIATE REMOVED THE IMPLANTABLE INFUSION PUMP AND THE ATTACHED INTRATHECAL CATHETER DUE TO AN INFECTION AT THE LUMBAR REGION. THE NEUROSURGEON STATED THAT HE REMOVED SOME NECROTIC TISSUE FROM SKIN AT THE LUMBAR REGION, HE DID NOT WANT THE INFECTION TO TRACK DOWN THE INTRASPINAL CATHETER TO THE IMPLANTABLE INFUSION PUMP POCKET, SO THE NEUROSURGEON ELECTED TO REMOVE BOTH THE INTRATHECAL CATHETER AND THE IMPLANTABLE INFUSION PUMP. THE NEUROSURGEON ALSO STATED THAT HE FELT THAT THE TISSUE INFECTION WAS LOCALIZED AT THIS TIME. THE IMPLANTING SURGEON'S PARTNER/ASSOCIATE STATED IN HER PROGRESS NOTES THAT THE DEVICE WAS FUNCTIONING WITHOUT DIFFICULTY AND THE INTRATHECAL CATHETER WAS INTACT UPON REMOVAL. THE PHYSICIAN DID NOT WANT THE IMPLANTABLE INFUSION PUMP OR THE CATHETER TO BE ANALYZED SINCE THEY FELT THAT THE EXPLANT WAS DUE TO AND INFECTION AT THE LUMBAR REGION, NOT TO EITHER THE PUMP AND/OR THE CATHETER. THE DEVICE AND THE CATHETER WERE REMOVED TO PREVENT SPREAD OF THE INFECTION AND POTENTIAL COMPLICATIONS. THE NEUROSURGEON STATED THAT THERE WAS A SMALL PIECE OF EPIDURAL CATHETER IN THE DURA SPACE FROM THE PREVIOUS INSERTION (8/26/96), BUT HE CHOSE TO LEAVE THIS PORTION OF THE EPIDURAL CATHETER IN THE DURA SPACE TO PREVENT THE PT FROM FURTHER EXPOSURE TO INFECTION. THE CATHETER THAT WAS ATTACHED TO THE IMPLANTABLE INFUSION PUMP AND THE INTRATHECAL CATHETER THAT WAS EXPLANTED WERE INTACT AND NO TEARS OR BREAKAGE WAS NOTED. THE PHYSICIANS DO NOT WANT ANY FURTHER FOLLOW-UP PERFORMED REGARDING THIS EVENT. THE DEVICE WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS; THEREFORE, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG/LOT NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT. BASED ON THE INFO AVAILABLE, THIS EVENT APPEARS TO BE ATTRIBUTABLE TO THE SURGEON ACCIDENTALLY SHEARING THE EPIDURAL CATHETER WITH THE TOUHY NEEDLE WHILE ATTEMPTING TO PULL OUT THE DEVICE GUIDEWIRE. NO FURTHER DETRAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. OTHER LOT/SER NO: 5392 002.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER HAD A FATIGUE AND WEAR LEAK. TUBING WAS FUNCTIONAL.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. OTHER LOT/SER NO: 0777Q 002.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD OR DAMAGE. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
THE DEVICE WAS USED DURING A BOWEL PROCEDURE. THE SURGEON HAD TO BRING TWO PTS BACK TO OR FOR ANASTOMOTIC LEAKS PTS WERE OK SUBSQUENTLY. STANDARD BOWEL ANASTOMOSIS. THE TWO INSTRUMENT AFFECTED WERE DISCARDED BY HOSP, THREE SEALED INSTRUMENTS FROM SAME LOT BEING RETURNED FOR EVAL. ALL INSTRUMENTS MUST BE ANALYZED.
D5,6; H3,4,6; G4: ADDED ADDITIONAL INFO. CONCLUSION: BASED ON THE INFO RECEIVED AND THE FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THERE WERE THREE STERILE INSTRUMENTS RETURNED FOR EVALUATION. ALL THREE INSTRUMENTS WERE ANALYZED AND ALL FIRED AND FORMED STAPLES AS DESIGNED. ADDITIONALLY, STAPLE HEIGHTS AND STAPLES FORMATION WERE MEASURED ON ALL THREE INSTRUMENTS AND FOUND TO BE CONFORMING WITH RESPECT TO MFG REQUIREMENTS. IT COULD NOT BE DETERMINED AS TO HOW OR WHY THE STAPLE LINE REPORTEDLY LEAKED. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
REUSE TECHNICIAN WAS PERFORMING DIALYZER REUSE ON A REUSE CART. ONLY ONE DIALYZER ON SYSTEM TO BE REPROCESSED. OPERATORS MANUAL AND DIALYZER FACILITY REUSE MANUAL WARN THAT THE CART SHOULD BE OPERATED WITH MINIMUM OF FOUR DIALYZERS. DURING THE DISINFECTANT FILLINGS STAGE, A LINE DISCONNECTED SECONDARY TO INCREASED PRESSURE IN SYSTEM AND TECHNICIAN WAS SPRAYED WITH A MIXTURE OF FORMALDEHYDE AND RO WATER ESTIMATED TO BE <.8% FORMALDEHYDE. THE SPRAY HIT THE REUSE TECHNICIAN'S FOREHEAD AND TRICKLED DOWN BEHIND HIS FACE SHIELD INTO HIS EYES. HE IMMEDIATELY FLUSHED HIS EYES AT THE EYE WASH STATION FOR 20 MINUTES. HE WAS THEN TAKEN TO THE LOCAL HOSP. THERE, HIS EYES WERE FLUSHED WITH 1 LITER NSS AND HE WAS GIVEN BLEPH-1 EYE DROPS, ORDERED TID. OTHER INSTRUCTIONS INCLUDED FOLLOW-UP IN 24 HRS WITH HIS PRIVATE PHYSICIAN OR CLINIC, AND RETURN TO WORK NEXT DAY. DIAGNOSIS: CHEMICAL CONJUNCTIVITIS, +MILD SCLERAL INJECTION. REUSE TECHNICIAN DID NOT SEEK FOLLOW-UP ON HIS OWN ACCORD. HIS SUPERVISOR ARRANGED FOR THE DIALYZER FACILITY MEDICAL DIRECTOR TO SEE HIM. NO PROBLEMS, REDNESS OR IRRITATION NOTED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO EROSION-PUMP.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO ANEURYSMAL DILATION OF CYLINDER AND PUMP TUBING-HOLE.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. "WHEN THE INSTRUMENT WAS FIRED THE STAPLES DID NOT FORM, CONSEQUENTLY THE RETURN WAS NOT CLOSED. THE STAPLES WERE ONLY PUSHED OUT A LITTLE BIT OUT OF THE CARTRIDGE. THE PT REC'D AN OSTOMY OUT ON THE STOMACH WHICH THEY WILL TAKE DOWN TO RE-ESTABLISH THE COLON CONTINUITY".
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
REUSE TECHNICIAN SPRAYED IN LEFT EYE WITH <0.7% FORMALDEHYDE SOLUTION WHILE ATTEMPTING TO PERFORM REUSE ON ONE DIALYZER. POLICY, PROCEDURES AND DEVICE LABELING (OPERATORS MANUAL) REQUIRE A MINIMUM OF FOUR DIALYZERS TO BE PROCESSED AT ONE TIME. IMPROPER OPERATION OF THE CART CAUSED EXCESS PRESSURE RESULTING IN A FLUID LINE BECOMING UNATTACHED.
H6: OPERATING CONDITIONS AT THE TIME OF THE EVENT SIMULATED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED BECAUSE IT HAD "FAILED". OTHER LOT/SER NO: 0639T 001.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDERS. OTHER LOT/SER NO: 1680P 006.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. "DUE TO CLIP SCISSORING SO AS TO RESULT IN FAILED LIGATION ONE CASE HAS RESULTED INFECTION". THERE WAS NO CONSEQUENCE TO THE PT, HOWEVER, THERE WAS EXTENDED OP TIME. 8/23/96 THERE WERE NO INTERVENTIONS REQUIRED.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-RIGHT CYLINDER. OTHER LOT/SER NO: 1837Q 013.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO BULGING--LEFT CYLINDER SPLIT. OTHER LOT/SER NO: AV370 009
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE "DOCTOR NEED TO USE THE INSTRUMENT ER320 TO CLAMP A BLEEDING AND NEED TO USE 3 ER320 AND THE CLIPS DON'T CLOSE". DR. CONVERTED TO OPEN PROCEDURE TO CONTROL THE BLEEDING.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO PAIN AND PT WAS NOT USING THE PROSTHESIS.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AT CYLINDER NEAR TUBING AND REPLACED. OTHER LOT/SERNO: 9884L 006.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. TUBING WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. CYLINDER HAD TORN FABRIC AND BULGING.
ON 6/17/93 DEVICE WAS IMPLANTED. ON 7/27/94 THE RIGHT CYLINDER WAS REVISED. ON 8/13/96 THE PUMP WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE PUMP WAS DEFECTIVE-CRACK IN TUBING FROM RESERVOIR AT PUMP.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT AND REPLACED WITH 14MM GRAFT DISTALLY DUE TO PENDING EROSION URETHRALLY OF THE RIGHT CYLINDER.
WHILE PT WAS USING LATEX GLOVES SHE DEVELOPED SYMPTOMS OF HIVES AND LATER ON, PROGRESSED INTO ASTHMA. PT TOOK MEDICATION WITHOUT ANY POSITIVE RESULTS. PT WAS REQUIRED TO CARRY AN EPI-PEN, A PROVENTIL INHALER AND USE ATRAC TRAIN. PT IS NO LONGER WORKING AS AN RN. PT STATED THAT EVERY TIME SHE GOES TO A GROCERY STORE OR A TOY STORE SHE GETS AN ALLERGIC REACTION.
QR AXLE WITH NUT. DELAER CLAIMS QR AXLE PIN SNAPPED OFF AND SPRING CAME OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT WAS HAVING AN ABDOMINAL ARTERIOGRAM TO DETERMINE IF THERE WAS LEAKAGE FROM AN ANEURYSM. AS THE GUIDE WIRE WAS BEING INSERTED IT WAS NOTED THAT THERE WERE TWO SECTIONS GOING IN OPPOSITE DIRECTIONS. GUIDE WIRE WAS REMOVED INTACT. CORE WIRE HAD PENETRATED THE OUTER COVERING.
RADIOLOGY REPORT OF L-S SPINE REVEALED PEDICLE SCREW BROKEN WITHIN BONE. THIS WAS NOT NOTED ON PRIOR RADIOLOGICAL STUDY. FUSION STABLE. PT DOING WELL.
QR AXLE WITH NUT. DEALER CLAIMS QR AXLE NO LONGER HAS BEARINGS.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYED, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INTRAAORTIC BALLOON PUMP AFTER 6 DAYS SUDDENLY QUIT FUNCTIONING. IN REMOVING IT, IT WAS NOTED BALLOON WAS BLOOD FILLED AND IT HUNG UP IN THE FEMORAL ARTERY REQUIRING EMERGENCY TRIP TO OR TO REMOVE BALLOON. PT'S ARTERY WAS REPAIRED. POSITION ON AM CHEST X-RAY WAS WITHIN NORMAL LIMITS. REPOSITIONING AFFORDED NO IMPROVEMENT. ATTEMPT AT REMOVING BALLOON REVEALED THAT BALLOON HAD RUPTURED AND THAT IT COULD NOT BE PULLED BACK THROUGH ILIACS SECONDARY TO INCOMPLETE CLOSURE FROM CLOT AND BLOOD IN BALLOON. PT TAKEN TO OR EMERGENTLY WHERE FEMORAL ARTERY EXPLORATION PERFORMED. BALLOON REMOVED AFTER FEMORAL ARTERIOTOMY PERFORMED. FEMORAL AND PROFUNDA ARTERY REPAIRED AND FLOW REESTABLISHED TO DISTAL LEFT LOWER EXTREMITY CONFIRMED BY DOPPLER SIGNAL AT DISTAL PROFUNDA AND AT POSTERIOR TIBIAL. PT TOLERATED BALLOON REMOVAL WITHOUT SIGNIFICANT HEMODYNAMIC COMPROMISE. APPROX 1200 CC BLOOD LOSS. RECEIVED 2 UNITS PACKED RED BLOOD CELL. WILL NEED TO MONITOR FOR HEMODYNAMIC DETERIORATION. PT TOLERATED SUDDEN CESSATION OF IABP. IABP INFO: IMPLANTED - 15 AUG 95. MALFUNCTION - 19 AUG 96. EXPLANTED - 19 AUG 96.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, INC ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
STAFF NURSE WAS UNKNOWINGLY EXPOSED TO GLUTARALDEHYDE AT WORK PLACE FOR 1 YR. NURSE HAS "MCS" DUE TO EXPOSURE. SHE MISSED 16 MOS OF WORK OVER A 21 MONTH PERIOD DUE TO SYMPTOMS AND PROBLEMS ASSOCIATED WITH THIS PRODUCT.
DURING AN INVESTIGATION INTO A SUBSEQUENT REVISION, A PREVIOUSLY UNREPORTED EVENT WAS DISCOVERED. PER THE INFO PROVIDED TO CO THROUGH MEANS OF THE PHYSICIAN/SURGEONS OPERATIVE NOTES, AN "EXPLORATION OF A PENILE PROSTHESIS DUE TO PAIN" WAS PERFORMED AS WELL AS THE REMOVAL OF FOREIGN BODY AND RECONSTRUCTION OF THE SUSPENSORY LIGAMENTS OF THE PENIS. AS STATED, INDICATIONS "CHRONIC PAIN WITH RIGHT EPIDIDYMAL ORCHITIS AND HE HAS BEEN UNABLE TO USE THE DEVICE". DURING THE PROCEDURE IT WAS STATED, " A HARD 1 CM ROUND MASS WAS PALPATED ABOUT 3 CM LATERAL TO THE INCISION SITE AND REMOVED. THIS APPEARED TO BE A SPONTANEOUS CALCIFICATION OF A BLOOD VESSEL IN THE SUBCUTANEOUS TISSUE" REAR-TIP EXTENDERS WHICH TOTALLED 4 CM ON THE RIGHT SIDE AND 5 CM ON THE LEFT SIDE, WERE REMOVED".
BASED ON THE INFO RECEIVED, THIS EVENT WAS NOT DIRECTLY RELATED TO DEVICE FUNCTION AND THE DEVICE HAS REMAINED IMPLANTED. THE MASS REFERENCED WAS REMOVED AND REAR TIP EXTENDERS WERE EXCHANGED TO ADJUST THE SIZING. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
NITRAZINE PAPER DISPENSER WAS PICKED UP TO USE. ENTIRE CONTENTS WERE LIGHT GREEN (PH APPROX 5.5). TAPE USUALLY COMES BRIGHT YELLOW FROM MFR. NOT AWARE OF ANY EXPOSURE TO ALKALI OR ACID FUMES. PRODUCT RETURNED TO PHARMACY NOT USED.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED WITH A 00-5220-00.
THREE PACKAGES OF NITRAZINE PAPER RECEIVED FROM WHOLESALER ALREADY READING PH 5.5-6.0.
DEVICE WAS DISCARDED BY CUSTOMER AFTER USE. EVALUATION NOT POSSIBLE.
ON 8/23/96, THE FACILITY O.R. MATERIALS MANAGEMENT CONTACTED A MANUFACTURER REP AND REPORTED THAT THE PHYSICIAN HAD IMPLANTED THE DEVICE ON 8/19/96. IT WAS ADDITIONALLY STATED THAT DURING SURGERY, THE DEVICE CATHETER WAS ATTACHED TO THE HEPATIC ARTERIAL SUPPLY. AFTER DOING FLUORESCEIN DYE BOLUS VIA THE DEVICE SIDEPORT, THE SURGEON REALIZED THAT HE HAD USED A STRAIGHT, NON-HUBER NEEDLE RATHER THAN AN ANTI-CORING HUBER POINT NEEDLE. AS A RESULT, RATHER THAN RISK DEVICE MALFUNCTION, THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS OBTAINED FROM FACILITY INVENTORY TO COMPLETE THE SURGERY, NO FURHTER INFO IS AVAILABLE.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: THE CENTER AND SIDEPORT SEPTA SHOWED ONLY NEEDLE PENETRATION MARKS WITH NO EVIDENCE OF INTERNAL DAMAGE. THE 3.5 INCH CATHETER WAS FREE OF CUTS, TEARS OR HOLES. THE SIDEPORT/CATHETER WERE PATENT. THIS PUMP FLOWED WITHOUT ORIGINAL MFR FLOW RATE SPECIFICATIONS AS RECEIVED. LEAK TESTING CONFIRMED THE DEVICE DID NOT LEAK. NO DEFECTS OR ANOMALIES WERE FOUND DURING THE MFR'S ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. BASED ON THE INFO AVAILABLE, THE SURGEON ELECTED TO REPLACE THE DEVICE RATHER THAN RISK A POTENTIAL DEVICE MALFUNCTION IN THE FUTURE, AFTER THE DEVICE SIDEPORT SEPTUM HAD BEEN ACCESSED WITH THE INCORRECT NEEDLE. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
REAR S/F DAB L. DEALER CLAIMS SIDE FRAME BROKEN AT THE BACK POST LOCATION.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY CO, UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO,
PLASTIC COMPONENT SEPARATED FROM METAL COMPONENT.
EVALUATION CODES FOR SECTION H6: 86-100 DEVICE WAS NOT RETURNED. THEREFORE NO EVALUATION COULD BE MADE. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
PT SELF EXTUBATED HER SELF ON AUGUST 9/96. THE EVENT OCCURRED IN A FOUR BED ICU, ONE RN WAS IN AN ISOLATION ROOM WITH THE DOORS CLOSED. A SECOND RN WAS CARING FOR A PT IN THE ADJACENT ROOM AND DID NOT HEAR THE ALARM ACTIVATE. THE NURSE SUPERVISOR WAS WALKING INTO THE ICU AND HEARD THE ALARM AND INITIATED A CODE. THE PT WAS A 75 YR OLD FEMALE WITH A DIAGNOSIS OF CHF, RENAL FAILURE. RESUSCITATION WAS NOT SUCCESSSFUL AND THE PT EXPIRED.
THE VENTILATOR MEETS MFR SPECS. THIS EVENT WAS DUE TO USER ERROR.
LEAD WAS REMOVED FROM SERVICE BECAUSE OF AN INSULATION BREAK. DURING A ROUTINE REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THIS INSULATION BREAK WAS NOTED, THE PHYSICIAN ELECTED TO REPLACE ALL THE LEADS WITH ANOTHER TRNASVENOUS DEFIBRILLATION LEAD. IMPLANTED 4/2/93. OUT OF SERVICE 8/15/96. IMPLANT MONTHS 40.4.
AT SECOND STAGE SURGERY IMPLANT WAS LOOSE. DID NOT INTEGRATE.
AN ABUTMENT FRACTURED AT BASE. PT REPORTED TO BE IN EXCELLENT CONDITION.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DR.'S OFFICE.
THE SCREW BROKE INSIDE THE ABUTMENT. PT IS SAME PT AS PRIOR MDR REPORT #M763528.
ON 6/29/92 RPTR HAD A BILATERAL MANDIBULAR JOINT RECONSTRUCTION. NOV OF 1993 RPTR DEVELOPED SWELLING IN HER RIGHT HIP. RPTR ALSO UNABLE TO DO REGULAR AEROBICS AND HAD TO HAVE EXTENSIVE PHYSICAL THERAPY AND CORTISONE INJECTIONS IN THE RIGHT TMJ. RPTR ALSO EXPERIENCED HEEL SWELLING AND PAIN AND NECK AND LEFT HIP JOINT INFLAMMATION. SHE WAS TREATED WITH CORTISONE INJECTIONS. SHE WAS REFERRED TO SEVERAL SPECIALISTS AND UNDERWENT SEVERAL TESTS. SHE HAS BEEN PRESCRIBED MULTIPLE MEDICATIONS WITH SOME SIDE EFFECTS. RPTR HAS HAD TO RETIRE. (*)
AN BAUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
LEAD WAS REMOVED FROM SERVICE DUE TO "LEAD ABRASION." DURING A ROUTINE REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILATOR (ICD) THIS LEAD WAS REPLACED WITH A NEW BIPOLAR LEAD. IMPLANTED -1/7/93. OUT OF SERVICE -8/19/96. IMPLANT MONTHS. 43.4.
THE DEVICE DID NOT STOP WHEN INTERIOR LEVEL OF CRANIAL BONE WAS PERFORATED WHICH RESULTED IN INJURY OF THE DURA.
A REVIEW OF THE MFG LOT HISTORY RECORDS REVEALED NO DISCREPANCIES FOR THIS PRODUCTION LOT. CASE DEBRIS NOTED ON RETURNED DEVICE. NICKS/DENTS ON OUTER AND INNER DRILL. DIMENSIONAL INSPECTION DISCOVERED NO DISCREPANCIES. UNIT WAS CLEANED AND REBUILT. IT WAS THEN TESTED FOR PROPER FUNCTION AND PERFORMANCE PROPERLY FOR TEN TEST HOLES. THE REPORTED FAILURE COULD NOT BE REPEATED.
AFTER SOAKING CONTACT LENSES IN A DISINFECTING SOLUTION OVERNIGHT, RPTR PUT ONE LENS IN HER EYE IN THE MORNING AND IMMEDIATELY HER EYE STARTED BURNING "LIKE FIRE." THE RPTR WASHED EYE BUT COULD NOT STOP THE BURNING AND WENT TO A NEARBY HOSP TO HAVE EYE IRRIGATED. RPTR DID NOT READ LABEL ON BACK OF PRODUCT THAT WARNED TO NOT GET PRODUCT INTO EYE. (*)
REAR S/F DAB PNTD L Q2. DEALER CLAIMS THE REAR SIDE FRAME BROKE AT THE POINT WHERE THE BACK TUBE ATTACHES.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTER INFO SUBMITTED BY CO, UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WHILE DRILLING IN THIN BONE, THE DURA WAS NICKED. PT IS OKAY.
DEVICE WAS DISCARDED BY CUSTOMER AFTER USE. EVAL NOT POSSIBLE.
WHILE DRILLING IN THIN BONE, DURA WAS NICKED. PT IS OKAY.
CATHETER WAS PLACED IN PT. THE CARDIAC OUTPUT FAILED.
DURING A REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), LEAD WAS REMOVED FROMN SERVICE BECAUSE OF "BLOOD IN THE LUMEN OF THE LEAD AND A TEAR OF THE INSULATION." THE PHYSICIAN ELECTED TO CAP BOTH LEADS, THE SECOND LEAD WAS A COINCIDENT REMOVAL, AND REPLACE THEM WITH ONE SENSING LEAD. IMPLANT -10/28/92. REMOVED FROM SERVICE -8/12/96. IMPLANT MONTHS -43.5. MONTHS 57. BIPOLAR LEAD IMPLANTED -12/6/94. REMOED FROM SERVICE -8/12/96. IMPLANT MONTHS -19.2.
PT COMPLAINS THAT GASTROSTOMY KIT NEEDS REPLACING EVERY 2 MONTHS OR SO BECAUSE THE PLUG KEEPS BREAKING.
THE LEAD REMAINS IMPLANTED IN PT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO WAS UNABLE TO DRAW CONCLUSION FROM AVAILABLE INFO ON THE ALLEGED DAMAGE. NO FURTHER INFO WAS AVAILABLE.
ON 8/22/96, THE FACILITY'S O.R. REPRESENTATIVE INFORMED MFR SALES REP THAT THE PHYSICIAN HAD DIFFICULTY REMOVING THE DEVICE CATHETER FROM A PEDIATRIC PT'S VEIN. THE DEVICE CATHETER ADHERED ITSELF TO THE PT'S VEIN AND BROKE WHEN TRYING TO REMOVE WITH HEMOSTATS. THE BROKEN PIECE OF DEVICE CATHETER WAS NOT RETRIEVABLE. THE DEVICE WAS IMPLANTED FOR APPROX 2 1/2 YEARS AND WAS BEING REMOVED DUE TO COMPLETION OF THERAPY. THE PHYSICIAN HAS REPORTED TWO DIFFERENT EVENTS AND THIS REPORT WILL INVESTIGATE THE FIRST INCIDENT (REF. MDR#: 1219454-1996 00415, FOR INFO ON THE SECOND INCIDENT). THE EXPLANTED DEVICE WAS SENT TO THE FACILITY'S PATHOLOGY DEPT AND DISCARDED.
ON 11/20/96, THE PHYSICIAN WAS CONTACTED IN AN ATTEMPT TO OBTAIN THE LOT NUMBER FOR THIS DEVICE, AS WELL AS THE TYPE OF CHEMO BEING INFUSED THROUGH THE DEVICE. THE PHYSICIAN STATED THAT LOT NUMBERS ARE UNK; HOWEVER, HE PROMISED TO FAX THE INFORMATION RELATED TO THE TYPE OF CHEMO BEING INFUSED THROUGH THE DEVICE AS SOON AS HE RECEIVED THE INFORMATION FROM THE HOSPITAL. A FAX, DATED 11/20/96, WAS RECEIVED FROM THE PHYSICIAN WHICH IDENTIFIED THE FOLLOWING DRUP PRODUCTS:VINCRISTINE, METHOTREXATE, 6-MERCAPTOPURINE, TPN, ZOFRAN. A LITERATURE SEARCH WAS PERFORMED ON POLYURETHANE CATHETER REACTIONS AND HAS IDENTIFIED AN ARTICLE (POLYURETHANE CATHETER AND ANTINEOPLASTIC CHEMOSTHERAPY) FOR THE PHYSICIAN'S REVIEW. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFORMATION AVAILABLE AND DUE TO THE UNAVILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. THE FACILITY WILL BE NOTIFIED OF CO'S REVIEW OF THIS INCIDENT AND FORWARDED THE ABOVE REFERENCE ARTICLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
CODE 86: EVAL OF EVENT BASED ON HISTORY OF DEVICE, MANUFACTURING AND QC PROCEDURES, AND CONTENT OF EVENT DESCRIPTION. THIS EVENT WAS REPORTED TO CO AS A CUSTOMER COMPLAINT. ON THE MORNING OF 8/1/96, PRODUCT WAS USED FOLLOWING DIAGNOSTIC CATHETERIZATON. IT WAS REPORTED THAT PT MOVED DURING THE PROCEDURE. FOLLOWING THE PROCEDURE, PT SITTING UP, A SMALL HEMATOMA DEVELOPED. A PRESSURE DRESSING AND SANDBAG (WHICH IS NOT RECOMMENDED POST PRODUCT) WAS APPLIED. APPROX. 1 HR LATER, THE HEMATOMA WAS SMALLER. LATER THAT AFTERNOON, PT COMPLAINED OF PAIN. MEDICATION WAS GIVEN AND PT IMMEDIATEDLY VOMITED. THE HEMATOMA GREW AND APPARENTLY WAS NOT TREATED. AT 5:00 PM, LOC, VAGAL, PT TRANSFERRED TO ICU. CLAMP APPLIED AND SURGICAL REPAIR OF ARTERIAL PUNCTURE FOLLOWED.
RPTR RECEIVED BREAST IMPLANTS AND BECAME ILL FOR MANY YEARS. ABLE TO WORK UNTIL RECENTLY WHEN SHE BECAME SO ILL THAT SHE WAS HOSPITALIZED TWICE AND DIAGNOSED WITH DERMATOMYOSITIS AND POLYMYOSITIS. RPTR HAS EXPERIENCED MULTIPLE SYMPTOMS TO INCLUDE FATIGUE, RASH, MUSCLE WEAKNESS, SEVERE PAIN AND FEVER. SHE IS DISABLED. (*)
X-TUBE ASSM 18" X 18". DEALER ALLEGES THE X-TUBE IS BROKEN AT CENTER BOLT, LEFT SIDE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO, UNDER 21 CFR PART 803, AND ANY RELASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CODE 86: EVAL OF EVENT BASED ON MANUFACTURING AND QC PROCEDURES, HISTORY OF DEVICE AND CONTENT OF EVENT DESCRIPTION. THIS INFO WAS REPORTED TO CO AS A CUSTOMER COMPLAINT. ON 7/31/96, PRODUCT WAS USED FOLLOWING CARDIAC CATHERIZATION. APPROX. TWO WEEKS LATER PT COMPLAINED OF DISCOMFORT IN THE GROIN. OVER NEXT COUPLE DAYS, THERE WAS INCREASED SWELLING, DRAINAGE AND PUSTULE, NO FEVER OR CHILLS. PT WAS ADMITTED TO HOSPITAL AND TREATED WITH ANTIBIOTICS. BLOOD CULTURE SHOWED GRAM+ COCCI. PT HAS BEEN DISCHARGED WITH NO FURTHER COMPLICATIONS. CODE 68: PRODUCT IS ASSUMED TO BE STERILE, BASED ON MANUFACTURING AND QC PROCEDURES. ATTRIBUTE INFECTION TO INADVERTENT CONTAMINATION DURING OR AFTER PROCEDURE.
CATHETER LINE INSERTED FOR DOPAMINE INFUSION. THREADED EASILY. PT COMPLAINED OF SEVERE PAIN IN BACK AND RIGHT ARM AND BECAME FLUSHED. BLOOD PRESSURE DROPPED 146/60 PULSE 64. CATHETER DISCONTINUED; PT'S COLOR IMPROVED, PAIN DECREASED.
DEVICE WAS IMPLANTED ON 4/24/96 FOR INFUSION OF FUDR/ LEUCOVORIN/DEXAMETHASONE/HEPARIN TREATMENT OF CANCER. ON 8/23/96, MFR SALES REP NOTIFIED A MFR NURSE THAT HE HAD BEEN CONTACTED BY THE PHYSICIAN WHO REPORTED THAT PT HAS AGAIN DEVELOPED A DEVICE POCKET HEMATOMA WHICH HAD APPEARED WITHIN A DAY OF A DEVICE REFILL. APPROX 100CC OF "GROSS BLOOD" WAS ASPIRATED ON 8/20/96; HOWEVER, EDEMA OF SITE HAD RECURRED BY 8/21/96 AND THE PHYSICIAN BELIEVED THAT BLEEDING WAS CONTINUING. THE MFR SALES REP REQUESTED THAT MFR NURSE SPEAK WITH  PHYSICIAN CONCERNING THIS EVENT. ON 8/23/96, PHYSICIAN CONTACTED MFR NURSE AND REPORTED THE ABOVE REFERENCED EVENTS. HE DID NOT HAVE ANY ADDITIONAL INFO CONCERNING DEVICE FUNCTION OR DRUGS USED IN REFILLING DEVICE. HE WAS NOT AWARE OF RECENT TRAUMA TO DEVICE SITE AND STATED THAT A HEPATIC ARTERIAL PERFUSION STUDY (HAPS) TO CHECK PATENCY AND INTEGRITY OF FLOW PATH WERE NOT POSSIBLE BECAUSE OF THE DEGREE OF SITE EDEMA, I.E. DEVICE PORTS COULD NOT BE LOCATED. PT WAS SCHEDULED FOR EXPLORATION OF DEVICE POCKET ON 8/26/96 AND  PHYSICIAN REQUESTED A MFR NURSE BE PRESENT. ON 8/23/96, PHYSICIAN'S NURSE PROVIDED THE FOLLOWING REFILL DATA: 6/3/96 - RESIDUAL VOLUME (RV) =21.5ML, REFILL PERIOD (RP) = 14 DAYS, FLOW RATE (FR) = 2.04ML/DAY; 6/17/96 - RV=28.5ML, RP = 14 DAYS, FR = 1.54ML/DAY; 7/1/96 - RV = 30ML, RP = 14 DAYS, FR = 1.43ML/DAY. THE FACILITY NURSE PHONED THE MANUFACTURER'S CLINICAL LINE AND IT WAS SUGGESTED THAT THE SIDEPORTS BE ACCESSED AND FLUSHED TO ACCESS PATENCY.; 7/3/96 - THE PT RETURNED TO THE OFFICE AND THE NURSE WAS ABLE TO ACCESS THE DEVICE EASILY AND FLUSH THE LOWER DEVICE SIDEPORT, BUT WAS NOT SUCCESSFUL IN LOCATING THE UPPER DEVICE SEPTUM. (DEVICE PORTS AT 1300 AND 1500 HRS); 7/12/96 - THE FACILITY NURSE ACCESSED BOTH DEVICE PORTS SUCCESSFULLY AND FLUSHED BOTH WITHOUT RESISTANCE; 7/17/96 - RV = 26.5ML, RP = 16 DAYS, FR = 1.66ML/DAY. THE DEVICE WAS REFILLED WITH HEPARIN/NS 40,000U/50ML; 7/29/96 - RV=27.5ML, RP=12DAYS, FR=1.88ML/DAY. THE DEVICE WAS REFILLED WITH FUDR/LEUCOVORIN/DEXAMETHASONE/HEPARIN CALCULATED BASED ON ACTUAL FLOW RATE; 8/7/96 - THE PT COMPLAINING OF RIGHT UPPER QUADRANT PAIN AND HYPERACIDITY. THE PT IS KNOWN HYPERSENSITIVE; HOWEVER, HIS BLOOD PRESSURE WAS ELEVATED AND HE WAS SEEN IN THE ER FOR TREATMENT. FUDR WAS REMOVED FROM THE DEVICE AND IT WAS REFILLED WITH HEPARIN/NS. RV=30ML, RP=9 DAYS, FR=2.22ML/DAY. ON 8/14/96, THE PT CONTINUED TO COMPLAIN OF UPPER RIGHT QUADRANT PAIN AND SWELLING WAS NOTED AROUND THE DEVICE SITE AFTER THAT DAYS REFILL. THE PT WAS SEEN BY THE PHYSICIAN. ON 8/21/96, THE DEVICE SITE WAS EDEMATOUS; HARD TO TOUCH. IT APPEARED TO HAVE A POINT THAT WAS PROTRUDING. AT THIS POINT THERE WAS ECCHYMOSIS. PT DID NOT COMPLAIN OF PAIN AT SITE. A DEVICE REFILL WAS NOT ATTEMPTED. ON 8/26/96, EXPLORATORY SURGERY WAS PERFORMED. SKIN OVER DEVICE AREA WAS ECCHYMOTIC AND EDEMATOUS. ON OPENING POCKET, A LARGE AMOUNT OF OLD BLOOD AND CLOT WAS REMOVED. TWO SUTURES WERE FOUND BROKEN.
ON 9/3/96, MFR SALES REP REPORTED THAT HE HAD FOLLOWED UP WITH FACILITY NURSE SUBSEQUENT TO EXPLORATORY SURGERY AND DEVICE HAD BEEN RE-ACCESSED AND REFILLED WITH FUDR ON 8/29/96 WITHOUT INCIDENT. FACILITY NURSE HAD PERFORMED DEVICE REFILL AND REPORTED ONLY MILD SEROMA WITH NO OTHER COMPLICATIONS. DEVICE IS FUNCTIONING AS INTENDED AND WILL REMAIN IMPLANTED FOR CONTINUED USE IN PT'S THERAPY REGIMEN. A REVIEW OF DEVICE HISTORY RECORD WAS PERFORMED ON THIS PART/SERIAL NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS PART NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. BASED UPON AVAILABLE INFO, THIS EVENT APPEARS TO HAVE BEEN RELATED TO PHYSIOLOGICAL (DUE TO PT'S INCREASED BLOOD PRESSURE - SEE DEVICE CLINICIAN'S MANUAL) AND PROCEDURAL RELATED FACTORS (DISCONNECTION OF SUTURES) AND NOT DUE TO DEVICE MALFUNCTION OR FAILURE. NO FURTHER DETAILS ARE AVAILABLE. MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
MIDLINE CATHETER REDRESSED THEN FLUSHED. LEAK NOTED AT CATHETER HUB JOINT. CATHETER REMOVED.
QR AXLE MAG WITH NUT. DELAER CLAIMS QR AXLE BROKE. BEARINGS CAME OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CODE 86: EVAL OF EVENT BASED ON MANUFACTURING AND QC PROCEDURES, HISTORY OF DEVICE AND CONTENT OF EVENT DESCRIPTION. THIS INFO WAS RECEIVRD BY CO AS A CUSTOMER COMPLAINT. ON 8/7/96 PRODUCT WAS USED FOLLOWING RENAL ANGIOPLASTY WITHOUT COMPLICATION. 8/14/96, PT ADMITTED TO ER WITH CHILLS, FEVER, RENAL FAILURE AND SEPSIS. AT THIS TIME NO COMPLICATIONS WERE APPARENT IN THE GROIN. A FEW DAYS LATER PSEUDOANEURYSM WAS IDENTIFIED THROUGH ULTRASOUND. 8/22/96, VASCULAR REPAIR WAS DONE. AN INFECTION WAS DISCOVERED IN THE GROIN. DR THINKS INFECTION CAUSED BY BREAK IN STERILE TECHNIQUE DURING PROCEDURE. INFECTION TREATED WITH ANTIBIOTICS. SECONDARY COMPLICATION, EMBOLUS. CODE 68: PRODUCT IS ASSUMED STERILE BASED ON MANUFACTURING AND QC PROCEDURES. INFECTION CAUSED BY INADVERTENT CONTAMINATION DURING PROCEDURE.
ON 8/22/96, THE FACILITY O.R. REPRESENTATIVE INFORMED THE MFR SALES REP THAT DURING REMOVAL OF THE DEVICE, THE PHYSICIAN NOTED, THAT THE DEVICE CATHETER APPEARED TO BE COVERED WITH CALCIUM DEPOSITS. THE DEVICE CATHETER WAS ROUGH LIKE SANDPAPER. THE DEVICE WAS BEING REMOVED DUE TO COMPLETION OF THERAPY. THE PHYSICIAN HAS REPORTED TWO DIFFERENT EVENTS. THIS REPORT WILL INVESTIGATE THE SECOND EVENT. (REF. MFR# 1219454199600414, FOR INFO ON THE FIRST INCIDENT). THE DEVICE WAS SENT TO THE FACILITY'S PATHOLOGY DEPT AND DISCARDED.
ON 11/20/96, THE PHYSICIAN WAS CONTACTED IN AN ATTEMPT TO OBTAIN THE LOT NUMBER FOR THIS DEVICE, AS WELL AS THE TYPE OF CHEMO BEING INFUSED THROUGH THE DEVICE. THE PHYSICIAN STATED THAT LOT NUMBERS ARE UNK; HOWEVER, HE PROMISED TO FAX TO INFORMATION RELATED TO THE TYPE OF CHEMO BEING INFUSED THROUGH THE DEVICE AS SOON AS HE RECEIVED THE INFORMATION FROM THE HOSPITAL. A FAX, DATED 11/20/96, WAS RECEIVED FROM THE PHYSICIAN WHICH IDENTIFIED THE FOLLOWING DRUG PRODUCTS: VINCRISTINE, METHOTREXATE, 6-MERCAPTOPURINE, TPN, ZOFRAN. A LITERATURE SEARCH WAS PERFORMED ON POLYURETHANE CATHETER REACTIONS AND HAS IDENTIFIED AN ARTICLE (POLYURETHANE CATHETER AND ANTINEOPLASTIC CHEMOTHERAPY) FOR THE PHYSICIAN'S REVIEW. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFORMATION AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. THE FACILITY WILL BE NOTIFIED OR CO'S REVIEW OF THIS INCIDENT AND FORWARDED THE ABOVE REFERENCED ARTICLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
SHEATH OF CATHETER CAME OFF WHILE PHYSICIAN WAS INSERTING IT. INCISION MADE TO REMOVE IT. PT OUTCOME WAS GOAL.
REAR S/F DAB R. DEALER CLAIMS REAR S/F BROKE BY THE BACKPOST.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CODE 86: EVAL OF EVENT BASED ON MANUFACTURING AND QC PROCEDURES, HISTORY OF DEVICE AND CONTENT OF EVENT DESCRIPTION. THIS INFO WAS RECEIVED AS A CUSTOMER COMPLAINT. PRODUCT WAS USED FOLLOWING DIAGNOSTIC CATHETERIZATION WITHOUT COMPLICATION. PT WAS DISCHARGED TO HOME, APPROX. 4.5 HRS LATER WITHOUT BANDAGE OVER SITE. THE FOLLOWING WEEK DURING ROUTINE CHECK, PT COMPLAINED OF SORENESS AROUND THE SITE. DR THOUGHT THIS WAS NORMAL HEALING PROCESS. TWO DAYS LATER, INFECTION WAS DIAGNOSED. PT HOSPITALIZED FOR IV ANTIBIOTIC THERAPY. CULTURE SHOWED S. AUREUS AND BETA HEMOLYTIC STREP. CODE 68:  PRODUCT IS ASSUMED TO BE STERILE, BASED ON MANUFACTURING AND QC PROCEDURES. ATTRIBUTE INFECTON INADVERTENT CONTAMINATION DURING OR AFTER PROCEDURE.
VASCULAR ACCESS WAS OBTAINED WITHOUT DIFFICULTY. CATHETER ADVANCED IN 2 INCH INCREMENTS AND PT STATED SHE FELT FINE. WHEN CATHETER COMPLETELY ADVANCED AND NURSE ATTEMPTED TO FLUSH WITH 3CC NS, PT C/O "FEELING FUNNY." PT'S FACE BEGAN TO TURN RED AND SHE C/O "FUNNY TASTE IN HER MOUTH." BP 140/80 P110 RR24. EMS CALLED AS REDNESS TRAVELED DOWN BODY, BASELINE VITALS: BP 100/64 - P68 RR 20.
REAR S/F DAB R. REAR S/F DAB L. DEALER CLAIMS REAR SIDE FRAMES ARE CRACKED IN THE REAR AREA.
VENTILATOR WOULD NOT ALLOW TO EXHALE. THERAPIST EXTUBATED IMMEDIATELY. PT RESUMED BREATHING ON HIS OWN. MACHINE SETTINGS: CPAP #6, PRESSURE SET #5.
IN THE EVENING OF 8/19, A BLOOD GLUCOSE RESULT ON THE PT'S METER WAS 391 MG/DL. THE METER HAD BEEN DROPPED ON 8/15 AND WAS IN THE WRONG MEASUREMENT MODE. THE METER WAS SET TO MMOL/L AND ANOTHER TEST WAS PERFORMED AT 6/P ON 8/19 WITH A RESULT OF 3.7 MMOL/L. ALTHOUGH THE PT FELT DEHYDRATED AND "NOT TOO WELL," THEY WERE NOT WORRIED. A KETONE TEST WAS DONE WITH A RESULT OF 13. THE FOLLOWING DAY, 8/20, THE PT VISITED HIS MOTHER AT WORK BECAUSE HE WAS "FEELING TOO TIRED." HE WAS TRANSPORTED TO THE HOSPITAL WHERE A HOSPITAL METER RESULT OF 25.6 MMOL/L WAS OBTAINED A 3/P. THE PT'S METER READ7.3 MMOL/L IN A FASTING STATE AT 1/P. HE WAS ADMITTED FOR HYPERGLYCEMIA AND TREATED WITH INSULIN. THE METER IS CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, HOWEVER, QUALITY CONTROL TESTS ARE NOT PERFORMED. CALIBRATION STATUS IS UNKNOWN AT THIS TIME.
CO HAS COMPLETED THE INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNK ANOMALY. AT THIS POINT CO'S INVESTIGATION OF THIS MATTER IS CLOSED.
THE STEM EXTENSION COMPONENT OF THE TIBIAL PROSTHESIS IS DISASSOCIATED ON X-RAY.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES.
5 1/4"+3/4 STEM W/HDWR. 6" PIST WITH SEMI PNEU (POLY) BRNG. DEALER CLAIMS THE CASTERS ARE FALLING OFF THE FORK ASSM.
WAITING FOR RETURN OF COMPONENTS TO EVALUATE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS,  OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING IM MED ADMINISTRATION THE SYRINGE SAFETY COVER BECAME LOOSE AND STARTED TO COME DOWN OVER THE NEEDLE OF THE SYRINGE DURING ASPIRATION.
X-TUBE ASSM 17" X 16". DEALER CLAIMS BROKEN.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THEE REPORTABLE EVENT.
THE STEM EXTENSION COMPONENT ON THE TIBIAL PROSTHESIS IS SHOWN TO BE DISASSOCIATED ON X-RAY.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES.
ON 8/15, THE PT, A IDDM AND DIALYSIS PT, BEGAN FEELING VERY SICK WITH VOMITING. A 9/A BLOOD GLUCOSE RESULT ON HER METER, USING TEST STRIPS LOT # 1L5148, WAS 147 MG/DL. THE TEST WAS REPEATED BECAUSE SHE THOUGHT HER BLOOD GLUCOSE SHOULD BE HIGHER. THE RESULT WAS 45 MG/DL. SHE DID NOT TAKE HER INSULIN BECAUSE SHE "FELT TOO SICK." SHE WAS TRANSPORTED TO THE HOSPITAL BY A RELATIVE AT 11/A WHERE A FASTING LABORATORY BLOOD GLUCOSE RESULT OF 1000 MG/DL WAS OBTAINED. THE PT WAS TREATED WITH FLUIDS AND AN INSULIN DRIP AND RELEASED ON 8/19. SHE WAS TOLD SHE WAS DEHYDRATED. THE PT'S HEMATOCRIT ON 8/3 WAS 27.5%. THE LABELED HEMATOCRIT RANGE FOR THE METER IS 25-60%. HEMATOCRITS NEAR OR OUTSIDE OF THESE RANGES MAY PRODUCE INACCURATELY LOW RESULTS. THE METER IS NOT CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, IT IS CLEANED ONLY WHEN IT DISPLAYS "CTA" (CLEAN TEST AREA) AND CONTROL SOLUTION IS USED TO CLEAN THE METER OPTICS RATHER THAN THE RECOMMENDED CLEAR WATER. CALIBRATION STATUS IS UNKNOWN.
CO HAS COMPLETED CO'S INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAS NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNK ANOMALY. AT THIS POINT CO'S INVESTIGATION OF THIS MATTER IS CLOSED.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY. ALL INFO OBTAINED BY CO. REPORT RECEIVED FROM THE FIELD INDICATED THAT, DURING CLINICAL USE, THE BALLOON BURST AT 6 ATMS. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAM: NO VISUAL ANOMALIES WERE NOTED. FUNCTIONAL TESTING: THE BALLOON WAS INFLATED WITH WATER, USING AN INDEFLATOR, WHICH REVELAED THE PRESENCE OF PINHOLE-TYPE LEAK SOURCES, 1.4 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAM: FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS ADJACENT TO AND INTERSECTING THE TEAR EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
LEADS WERE REMOVED FROM SERVICE DUE TO AN INSULATION BREAK. DURING A ROUTINE REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE PHYSICIAN NOTED THE LEADS HAD A SILASTIC INSULATION BREAK. THE LEADS WERE CAPPED AND REPLACED WITH ANOTHER BIPOLAR LEAD. IMPLANTED 1/4/93. REMOVED FROM SERVICE-8/9/96. IMPLANT MONTHS-43.
DOCTOR SCOPED PT AND FOUND POLY DEBRIS. IT WAS REPORTED THAT PT HAD EITHER BROKEN INSERT DURING A FALL OR THAT INSERT WAS BROKEN DURING ANOTHER SURGICAL PROCEDURE. THEREFORE, PHYSICIAN AND DIRECTOR OF RISK MANAGEMENT AT HOSP HAVE RULED THAT THIS IS NOT A REPORTABLE INCIDENT.
THREE CONTACTS WERE MADE WITH USER FACILITY WHO HAS RULED THAT THIS IS NOT A REPORTABLE INCIDENT. NO OTHER INFO IS AVAILABLE PER USE FACILITY.
THE PT, A NIDDM, BEGAN OBTAINING LOW BLOOD GLUCOSE READINGS ON HER METER ON 8/16 AND 8/17. BASED UPON THESE READINGS, SHE DRANK ORANGE JUICE, ATE BREAKFAST AND SKIPPED HER INSULIN INJECTION. SHE TESTED LATER IN THE DAY ON 8/17 WITH A RESULT OF 53 MG/DL AND, 2 HRS LATER, 47 MG/DL. BECAUSE SHE WAS FEELING VERY THIRSTY AND DID NOT BELIEVE THE METER READINGS TO BE CORRECT, SHE PROCEEDED TO THE HOSPITAL. UPON ARRIVAL, HER BLOOD GLUCOSE READING WAS "900" (UNKNOWN METHOD). SHE WAS ADMITTED INTO INTENSIVE CARE FOR HYPERGLYCEMIA, TREATED WITH IV AND INSULIN AND RELEASED ON 8/20. METER MAINTENANCE AND CALIBRATION STATUS IS UNKNOWN AT THIS TIME.
THE LEAD REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM AVAILABLE INFO ON THE ALLEGED LOW IMPEDANCE. NO FURTHER INFO IS AVAILABLE.
FAILURE TO FORM SCAR TISSUE TO TISSUE AROUND SILICONE GEL IMPLANT. RECONSTRUCTION ON 10/5/94. NOW PRESENTS WITH EXCESSIVE PAIN, SHIFTING AND DISPLACEMENT OF THE IMPLANT. SUBSEQUENT ASSYMMETRY AND BREAST PTOSIS OF RIGHT BREAST.
PT WAS REFERRED TO THE EYE HOSP WITH ACANTHAMOEBA KERATITIS IN THE RIGHT EYE. THE PT IS REPORTEDLY COMPLIANT, ON DAILY WEAR REPLACEMENT USING MULTIPURPOSE SOLUTIONS.
CODES IN F10: CODE #1945 - LABELING; CODE #2204 - LABELING.
RESIDENT WAS BEING LOWERED BACK INTO BED AFTER BEING WEIGHED, THE DOWN BUTTON ON LIFT "STUCK" ALLOWING THE ARM OF THE LIFT TO COME DOWN ON THE RESIDENT'S ARM, CAUSING A 4CM SKIN TEAR ON LEFT FOREARM.
LIFT WAS INSPECTED, LIFT IN GOOD CONDITION, NO PROBLEMS COULD BE FOUND WITH THE LIFT ELECTRICAL OR MECHANICAL. CAUSE OF EVENT USER ERROR. CUSTOMER HAS BEEN INSTRUCTED TO REVIEW THE OPERATIONAL MANUAL FOR PROPER USE OF THE LIFT. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. ADD'L INFO WILL NOT BE PROVIDED AFTR 15-DAY REPORT. DISCLAIMER: THIS REPORT IS BASED ON INFO SUPPLIED TO US WITHOUT OUR INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE  PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21CFR600, 803, 1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
TWO LEADS WERE REMOVED FROM SERVICE DUE TO AN INSULATION BREAK. DURING A ROUTINE REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE PHYSICIAN NOTED THE LEADS HAS A SILASTIC INSULATION BREAK. THE LEADS WERE CAPPED AND REPLACED WITH A BIPOLAR LEAD. IMPLANTED-1/4/93. REMOVED FROM SERVICE-8/9/96. IMPLANT MONTHS-43.
VASCULAR ACCESS SYSTEM WAS NON-FUNCTIONING. WHEN REMOVING, IT WAS FOUND TO BE FRACTURED. THE RETAINED PORTION HAD TO BE REMOVED USING THE IMAGE INTENSIFIER.
THE LEAD REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM AVAILABLE INFO IN THE ALLEGED LOW IMPEDANCE. NO FURTHER INFO IS AVAILABLE.
TWO CNAS WERE TRANSFERRING RESIDENT FROM SHOWER CHAIR TO WHEELCHAIR USING THE ASSIST OF 2 UNDERARM METHOD AS STATED ON RESIDENT'S CARE PLAN. RESIDENT FELT WEAK AND WAS UNABLE TO BEAR WEIGHT, SO TO PREVENT HER FALLING THE CNAS LIFTED HER BY EACH GRASPING AN ARM AND A LEG. THE RESIDENT'S POSTERIOR MEDIAL RIGHT LOWER LEG CAUGHT ON THE END OF THE APPROX 3/4 INCH DIAMETER METAL BRACE ON THE RIGHT LEG OF SHOWER CHAIR CAUSING A 9 CM X 7 CM LACERATION REQUIRING 18 STITCHES TO CLOSE.
A RADIOPAQUE MARKER DETACHED IN THE VASCULAR SYSTEM UPON INTRODUCTION DURING A PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE MARKER WAS RETRIEVED WITH A SNARE AND A DILATOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PT COMPLICATIONS. THIS DEVICE IS CURRENTLY BEING EVALUATED BY THE MFR. UPON COMPLETION OF THE EVAL A SUPPLEMENTAL MW FORM WILL BE FORWARDED UNDER THE ABOVE NOTED SEQUENCE NUMBER. THE PT'S ANATOMY AND/OR USER TECHNIQUE MAY HAVE BEEN CONTRIBUTING FACTORS TO THIS EVENT. HOWEVER, UNTIL THE COMPLETION OF THE ENGINEERING EVAL, CO CANNOT DETERMINE THE CAUSE FOR THIS EVENT.
THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE RADIOPAQUE MARKER WAS MISSING FROM THE UNIT AND NOT RETURNED FOR EVALUATION. THE EXTRUSION CONTAINED ID WHERE THE MARKER HAD BEEN CRIMPED INTO POSITION. THE UNIT APPEARED BENT AND MANGLED. ALL OTHER ASPECTS OF THE UNIT WERE WITHIN REQUIRED SPECIFICATIONS. WITHOUT BEING ABLE TO EXAMINE THE RADIOPAQUE MARKER, A THOROUGH EVALUATION COULD NOT BE PERFORMED. CO THEREFORE CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. HOWEVER, THE CONDITION OF THIS DEVICE UPON RECEIPT, BENT AND MANGLED, MAY INDICATE EXCESSIVE MANIPULATION WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. H.6 #200 - OTHER/ENTIRE DEVICE WAS NOT RETURNED, THEREFORE UNABLE TO PERFORM COMPLETE EVALUATION.
BILATERAL BREAST IMPLANT EXCHANGE. LEFT NIPPLE MASTOPEXY. BOTH IMPLANTS INTACT.
STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S ILIAC ARTERY. UPON THE INFLATION ATTEMPT, THE DELIVERY BALLOON RUPTURED LEAVING THE STENT FULLY DEPLOYED AT THE TARGET LESION SITE. THE DELIVERY BALLOON WAS WITHDRAWN AND A FRAGMENTED PIECE OF THE DELIVERY BALLOON WAS NOTED ON THE DISTAL END OF THE STENT USING ANGIOGRAPHY. NO FURTHER ACTIONS WERE PERFORMED. THE FOLLOWING DAY, THE PT DEVELOPED STENT THROMBOSIS WHICH REQUIRED FEMORAL-FEMORAL BYPASS SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY. THE RESULTS OF THE PRODUCT EVALUATION IDENTIFIED A CIRCUMFERENCIAL TEAR AT THE PROXIMAL END OF THE DELIVERY BALLOON. THE BALLOON BODY AND DISTAL TAPER OF THE BALLOON WERE MISSING FROM THE DEVICE.
A BALLOON WAS ADVANCED FOR DILATATION OF A NATIVE ARTERIOVENOUS FISTULA PROCEDURE. UPON INFLATION THE BALLOON BEGAN TO "WATERMELON SEED" OUT OF THE LESION. THE PHYSICIAN REPOSITIONED THE BALLOON WHILE IT WAS STILL PARTIALLY INFLATED. FULL INFLATION OF THE BALLOON TO 10 ATMOSPHERES RESULTED IN A BALLOON BURST. WITHDRAWAL ATTEMPTS MET WITH RESISTANCE. CONTINUAL EXERTION ON THE CATHETER RESULTED IN CATHETER BREAKAGE AND A PORTION OF THE BALLOON DETACHED AND REMAINED IN THE PT'S ARM. SURGICAL RETRIEVAL OF THE DETACHED TIP UTILIZING A CATHETER WAS UNEVNTUL. POST-OPERATIVE COMPLICATIONS INVOLVED CARDIAC ARREST AND UNSUCCESSFUL RESUSCITATIVE MEASURES. THE PT SUBSEQUENTLY EXPIRED. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. A GUIDEWIRE WAS LODGED IN THE CATHETER. THE PROXIMAL END OF THE BALLOON WAS ATTACHED TO THE SHAFT, HOWEVER, THE DISTAL END WAS DETACHED ALONG WITH THE DISTAL TIP OF THE SHAFT, MEASURING 4CM LONG. THE DISTAL CATHETER SHAFT APPEARED ELONGATED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVER-PRESSURIZATION OR USE IN A C  ALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURE FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. CO'S FOLLOW UP INDICATED THE PT WAS EXTREMELY ILL PRE-PROCEDURE AND THAT FLUID OVERLOAD THE DAY BEFORE THE PROCEDURE RESULTED IN POSTPONEMENT OF THE DILATATION PROCEDURE FOR 24 HOURS. USER TECHNIQUE AND/OR PT ANATOMY/STATUS APPEAR TO HAVE BEEN CONTRIBUTING FACTORS IN THIS EVENT. CO'S ENGINEERING EVAL REVEALED ELONGATION OF THE CATHETER SHAFT AT THE DISTAL END IN THE AREA OF SHAFT BREAKAGE. THIS FINDING INDICATES CATHETER BREAKAGE RESULTED FROM FORCE EXERTED BEYOND THE TENSILE STRENGTH OF THE CATHETER. THEREFORE, CO DOES NOT ATTRIBUTE THIS EVENT TO THIS DEVICE.
F10. 1762-NOT LABELED. 1802 NOT LABELED. 2357 NOT LABELED. 1051. LABELED. 1527 NOT LABELED. 1528 LABELED.
DURING THE ADVANCEMENT OF A CORONARY STENT WITH DELIVERY SYSTEM TOWARD THE TARGET LESION SITE IN THE PT'S CORONARY ARTERY, THE STENT CAME OFF OF THE DELIVERY BALLOON AND REMAINED ON THE GUIDEWIRE. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATIONS AND A SNARE WIRE WAS USED TO SUCCESSFULLY RETRIEVE THE STENT FROM THE PT'S BODY. ANOTHER STENT WAS SUCCESSFULLY PLACED AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUEALE REPORTED RELATIVE TO THE EVENT.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY. ALL INFO OBTAINED BY CO. REPORT RECEIVED FROM THE FIELD INDICATED THAT, DURING CLINICAL USE, THE BALLOON BURST AT 6 ATMS. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. TEH FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAM: TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE BALLOON. FUNCTIONAL TESTING: THE BALLOON WAS INFLATED WITH WATER, USING AN INFLATION DEVICE, WHICH REVEALED THE PRESENCE OF PINHOLE-TYPE LEAK SOURCES, 1.5 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAM: FURTHER EVALUATION USING SCANNING ELECTON MICROSCOPY (SEM) REVEALED EVIDENCE OR EXTERNAL SURFACE ABRASIONS ADJACENT TO AND INTERSECTING THE TEAR EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
PT HAD SILICONE BREAST IMPLANTS REMOVED DUE TO BILATERAL CAPSULAR BREAST CONTRACTURES WITH RUPTURE OF BOTH IMPLANTS. RIGHT BREAST CAPSULE WAS FOUND TO BE RELATIVELY THIN IN THE INFERIOR PORTION. UPON OPENING THE CAPSULE, THE IMPLANT WAS FOUND TO BE GROSSLY RUPTURED AND COMPLETELY DISRUPTED. LEFT BREAST CAPSULE WAS OPENED AND IMPLANT FOUND TO BE THOROUGHLY DISRUPTED WITH FREE GEL PRESENT AND SHELL TOTALLY DISRUPTED.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. REPORT RECEIVED FROM THE FIELD INDICATED THAT, DURING CLINICAL USE, THE BALLOON BURST AT 15 ATMS. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. REPORTEDLY, THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. THIS FILE IS CONSIDERED CLOSED. SHOULD THE PRODUCT BE RETURNED AT A LATER DATE, A FOLLOW UP WILL BE SUBMITTED FOR YOUR REVIEW.
AFTER PERFORMING A DIAGNOSTIC COLONOSCOPY ON A PT WHO HAD A COMPLAINT OF DIARRHEA, RED STREAKS OF BLOOD WERE NOTICED IN THE COLON. THE RED STREAKS DID NOT APPEAR AT THE ONSET OF THE PROCEDURE AND THE PT HAD NO COMPLAINT OF BLEEDING. THE PT WAS RELEASED IN STABLE CONDITION AND NO FOLLOW UP WAS SCHEDULED SINCE THE PROCEDURE WAS COMPLETED. ALTHOUGH THE LAB RESULTS WERE NOT YET AVAILABLE, THE MD INITIALLY CONCLUDED THAT THE PT HAD INFECTIOUS COLITIS PERHAPS FROM CONTAMINATED FOOD OR WATER. WHEN THE COLONOSCOPE WAS EXAMINED AFTER THE PROCEDURE, A BURR WAS NOTICED AT THE DISTAL TIP. THE SCOPE HAS HAD THREE REPAIRS ALL PERFORMED BY THIRD PARTY REPAIR CENTERS AND EVEN AT THIS TIME, THE SCOPE WILL NOT BE RETURNED TO CO FOR EVAL.
PT UNDERWENT ABLATION PROCEDURE OF HEPATAIC CYSTS USING 300 CC DEHYDRATED ETHANOL INJECTED THROUGH CO'S 6 FRENCH ALL PURPOSE DRAINAGE CATHETER WITH LOCKING LOOPS, HYDROPHILIC COATING AND FLEXIMA FIRM MATERIAL. THE INJECTED ETHANOL WAS LEFT IN FOR 40 MINUTES AND THEN REMOVED ON 8/20/96. ON 8/22/96, IT WAS NOTED THAT ONE CATHETER WAS "TORN" NIXT TO THE MOLNAR DISC. UPON EXCHANGE IN THE CYST, ANOTHER PORTION WAS FRAGMENTED INSIDE THE CYST REQUIRING RETRIEVAL UNDER FLUOROSCOPY.
SECTION F WAS COMPLETED BY THE MFR. THE INFORMATION RECEIVED WAS THROUGH A CONSUMER. THE USER FACILITY HAS BEEN CONTACTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
DEVICE NOT RETURNED FOR EVALUATION. INFO PROVIDED NOT DETAILED ENOUGH TO ALLOW FOR ANY SPECULATION. H.11. A2 = 54 YEARS. A4 = 128.5 LBS. D5 = NA. D6 = MODEL #21-4683, SERIAL # NA, OTHER # NA. F12 = HOSP.
THIS REPORT WAS RECEIVED FROM A PHYSICIAN OF A MAN WHO HAD A 3-PIECE POSTERIOR CHAMBER IOL, MODEL 037B/16.00D, IMPLANTED ON 7/28/82. MORE RECENTLY, HE PRESENTED WITH DECREASED VISION (20/60), GLARE AND VITREOUS TOUCH SYNDROME. THE LENS WAS REMOVED ON 5/30/96 AND REPLACED WITH ORC UV40J. AN OPEN SKY VITRECTOMY WAS PERFORMED AND THE LENS SUTURED IN PLACE. HE WAS TREATED WITH PRED FORTE AND TOBREX OINTMENT. HIS PROGNOSIS IS EXCELLENT. HIS VISUAL ACUITY POST OP WAS 20/100 UNAIDED (NO GLASSES). THE PHYSICIAN BELIEVED THE ADVERSE REACTION TO BE LENS RELATED. ADD'L INFO IS BEING SOUGHT. LENS HAS BEEN RETURNED TO THE MFR FOR EVAL (CURRENTLY IN PROGRESS).
LENS IMPLANTED ON 8/5/96. PHYSICIAN REPORTED THAT AT ONE DAY POST-OP LENS APPEARED BROWN, PT'S VISUAL ACUITY 20/80. ON 8/15, VA WAS 20/200 AND IOL CONTINUED TO APPEAR BROWN. IOL REMOVED AND REPLACED ON 8/19/96, PT'S PROGNOSIS EXCELLENT.
USER INSERTED SWAB INTO EAR AND TIP BECAME LODGED IN EAR CANAL. REQUIRED MEDICAL ATTENTION TO REMOVE TIP.
THE EVENT RESULTED FROM MISUSE OF THE DEVICE IN THAT IT WAS INSERTERD INTO THE EAR DESPITE PACKAGE LABEL WARNING NOT TO DO SO.
PT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT DURING 1991. HE PRESENTED WITH COMPLAINTS OF PAIN WHILE AMBULATING ALTHOUGH HE USED NO ASSISTIVE DEVICES. THE PAIN AWAKENED THE PT AT NIGHT. HE REPORTED THAT HE FEELS A "POPPING" AND "CRACKING" WHEN HE WALKS AND THAT SOME SWELLING WAS PRESENT WITH NO REDNESS. THE PT WAS TAKEN TO SURGERY WHERE THE KNEE PROSTHESIS WAS REMOVED AND REPLACED. CULTURES WERE OBTAINED AT THE TIME OF SURGERY AND WERE REPORTED AS NEGATIVE FOR ORGANISM GROWTH. LOOSENING OF THE DEVICE WAS FOUND AT THE TIME OF SURGERY. THE CAUSE OF THE LOOSENING OF THER PROSTHETIC DEVICE WAS UNKNOWN.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE APPLIER WOULD NOT WORK PROPERLY. THE INSTRUMENT WAS SPITTING CLIPS THAT WERE UNFORMED. ANOTHER APPLIER WAS OPENED AND IT WORKED FINE. THERE WAS NO CONSEQUENCE TO THE PT. 08/23/1996 1825 IT WAS REPORTED 3 CLIPS FELL INTO THE PT AND ALL WERE RETRIEVED LAPAROSCOPICALLY.
H6: ADDED EVALUATION CODES (CODE 400=YIELDED JAWS). RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
DEVICES REMOVED DUE TO PAIN AND LOOSENING.
OTHER DEVICES USED: CATALOG #00-5110-065-38 M/G PATELLA DOME LOT #72867100CATALOG #00-5110-016-02 M/G FEMORAL COMP. LOT #74599200 CATALOG #00-5110-050-11 M/G ARTICULATING SURFACE LOT #71921000 EVAL. CODES FOR SECTION H6: 86-100 DEVICE WAS NOT RETURNED. THEREFORE NO EVAL. COULD BE MADE. IS THE FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE PT WAS RETURNED TO THE OPERATING ROOM POST-OPERATIVELY FOR DECREASING H&H. PT WAS SCOPED AND LAVAGED. OLD BLOOD WAS FOUND IN THE ABDOMEN. THE BLEEDING WAS ASSUMED TO BE FROM THE IP (BUT NOT NECESSARILY FROM THE STAPLE LINE) AND WAS CONTROLLED WITH THIS TREATMENT. PT DOING WELL NOW.
A1,2,3,4;B3,6,7;D10: INFORMATION UNAVAILABLE: 8/26/96 DR. TRIED TO CONTACT THE SURGEON. SENT NO CONTACT LETTER. CRB. D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
INFO RECEIVED ON 8/22/96 INDICATES THE DEVICE WAS REMOVED FROM THE PT DUE TO "CROSS-OVER."
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL.
THE APPLIER WAS USED DURNG A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS WOULD NOT ALIGN IN THE JAWS OF THE INSTRUMENT CAUSING SCISSORING WHEN THE CLIPS WERE APPLIED. THE SURGEON REMOVED THE CLIPS LAPAROSCOPICALLY. ANOTHER ER320 WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. 8/28/96 RECEIVED MED WATCH #01-0368732 STATING "UPON ACTIVATING CLIP APPLIER, JAWS MISALIGNED. PLEASE NOTE: PT NOT INJURED. THIS WAS A MALFUNCTION.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
INABILITY TO ACCESS BLOOD NOTED APPROX. ONE MONTH AGO IN PHYSICIAN'S OFFICE. PT RECEIVED CHEMOTHERAPY BETWEEN 4/3 & 4/8, AND 4/24-4/26. CHEMO WAS VP-16-(CBDCA) CARBOPLATINUM. PT ADMITTED TO HOSPITAL ON 8/17 WITH AN ADMITTING DIAGNOSIS OF LUNG CA AND PNEUMONIA. ON 8/19/96, A CHEST X-RAY REVEALED THE PORTACATH WAS FRACTURED, AND THE TUBING WAS CURLED PARTIALLY IN THE RIGHT ATRIUM. ON 8/20/96, AN INTRAVASCULAR FOREIGN BODY RETRIEVAL WAS SUCCESSFUL IN REMOVING THE TUBING FROM THE RIGHT ATRIUM. PT HAD NO IMMEDIATE COMPLICATIONS. THE REST OF THE PORTACATH WAS SURGICALLY REMOVED ON 8/21/96. PT WAS DISCHARGED ON 8/22/96.
IMPLANT WAS REMOVED ON 8/27/96. IT WAS IN PLACE FOR APPROX 2 MONTHS. DR. FEELS THAT PT HAD INSUFFICIENT BONE FOR THE IMPLANT.
AS THE REPORTED IMPLANT HAS NOT BEEN RETURNED CO , CO CANNOT BE SURE IT IS A CO PRODUCT. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED.
THE PT WAS RETURNED TO THE OPERATING ROOM POST-OPERATIVELY FOR DECREASING H&H. PT WAS SCOPED AND LAVAGED. THE BLEEDING WAS ASSUMED TO BE FROM THE IP (BUT NOT NECESSARILY FROM THE STAPLE LINE) AND WAS CONTROLLED WITH THIS TREATMENT. PT DOING WELL NOW.
A1,2,3,4;B3,6,7;D10: INFORMATION UNAVAILABLE. 8/26/96 DR. TRIED TO CONTACT THE SURGEON. SENT NO CONTACT LETTER. CRB. D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. THE FIRST DEVICE WAS FIRED, RELOADED WITH NO PROBLEM; THEY CLOSED THE DEVICE BUT IT WOULD NOT FIRE. A NEW DEVICE WAS OPENED. THE SECOND DEVICE WAS CLOSED BUT WOULD NOT FIRE; A NEW CARTRIDGE WAS LOADED, CLOSED AND ONLY HALF FIRED. A SECOND NEW CARTRIDGE WAS OPENED, CLOSED AND HALF FIRED, BUT HALF OF THE STAPLES WERE UNFORMED. THE SURGEON CHANGED TO A DIFFERENT DEVICE. THERE WAS NO CONSEQUENCE TO THE PT. FOUR RELOAD CARTRIDGES ARE BEING RETURNED WITH THE DEVICES.
D5,6; H3,4,6;G4: ADD ADDITIONAL INFO. D6: DEVICE RETURNED WITH NO LOT ID. H6; CODE 400: DAMAGED FIRING MECHANISM. RESULTS OF EVLAUATION: CONCLUSION: BASED UPON THE INFO RECEVIED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENTS WERE RETURNED NON-FUNCTIONAL. THE INSTURMENST WERE DISASSEMBLED AND WERE FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THORUGH A SPENT CARTRIDGE, FIRING PRIRO TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
H3: CATHETER RUPTURE-UNKNOWN CAUSE. PORTAL WAS RECEIVED WITH A 1.5 INCH LENGTH OF CATHETER ATTACHED, TOGETHER WITH A SEPARATE 6.5 INCH LENGTH OF CATHETER. MICROSCOPY EXAMINATION OF THE CATHETER ENDS SHOWED THAT THE CATHETER HAD FRACTURED. NO CONCLUSION AS TO CAUSE CAN BE DETERMINED FROM THIS INFO PROVIDED. IT IS UNKNOWN IF THE SYSTEM HAD BEEN MAINTAINED ACCORDING TO THE INSTRUCTIONS FOR USE SUPPLIED WITH THE PRODUCT. IT IS ALSO UNKNOWN WHERE THE PORTAL AND CATHETER WERE POSITIONED IN THE BODY RELATIVE TO THE FRAGMENTATION SITE. BOTH THE PORTAL, WITH ATTACHED CATHETER SEGMENT, AND THE SEPARATE CATHETER SEGMENT WERE TESTED AND FOUND TO BE PATENT.
IMPLANT FAILED. NO FURTHER INFO AT THIS TIME.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN REC'D. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
A BALLOON BURST AT EIGHT ATMOSPHERES ON THE FIRST INFLATION AND SUBSEQUENTLY DETACHED DURING SUBCLAVIAN DILATION OF A VERY CALCIFIED LESION. THE BALLOON MATERIAL WAS SUCCESSFULLY RETRIEVED WITH FORCEPS. A SECOND BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND THERE WERE NO PT COMPLICATIONS. DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE BALLOON MATERIAL WAS DETACHED FROM THE CATHETER SHAFT AND NOT RETURNED FOR EVALUATION. THE CATHETER SHAFT WAS KINKED AND THE PROXIMAL RADIOPAQUE MARKER WAS THIRTEEN MILLIMETERS PROXIMAL TO ITS ORIGINAL LOCATION. BOTH BALLOON BONDS WERE PRESENT ON THE SHAFT. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. IT WAS INDICATED THE LESION WAS HIGHLY CALCIFIED WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE.
THE DEVICE WAS BEING UTILIZED FOR A PERCUTANEOUS CHOLECYSTECTOMY PROCEDURE. THE PHYSICIAN WAS USING GRASPING FORCEPS TO ADVANCE THE CATHETER. UPON ATTEMPTED REMOVAL OF THE CATHETER, THE ACORN TIP SEPARATED AND REMAINED IN THE ABDOMINAL WALL. THE SEPARATED SEGMENT WAS LATER RETRIEVED DURING AN UNRELATED EXPLORATORY LAB.
AN EXAMINATION CONFIRMED THAT ACORN TIP ON ONE OF THE RETURNED CATHETERS HAS SEPARATED. AN EXAMINATION OF THE OTHER RETURNED DEVICE REVEALED AN ANCHORING CLIP TO BE FIRMLY ATTACHED TO THE CATHETER JUST PROXIMAL TO THE ACORN TIP. IT APPEARS THAT THE CLIP HAS NOT BEEN RELEASED PRIOR TO ATTEMPTED WITHDRAWL OF THE CATHETER. THE MATERIAL OF THE SEPARATED CATHETER SHOWED SIGNS OF ELONGATION INDICATING THE DEVICE HAS ENCOUNTERED RESISTANCE BEYOND ITS STRENGTH. CO CAN ADVISE THAT THE ANCHORING CLIP IS NOT SUPPLIED IN THIS SET AND IS NOT MFG BY CO.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIP APPLIER WOULD NOT FIRE CORRECTLY. THE DEVICE WAS SPITTING CLIPS AND THEY WERE FALLING OUT OF THE JAWS. THERE WAS NO CONSEQUENCE TO THE PT.
B3;D5,6;H4-INFORMATION UNAVAILABLE. F1:USER FACILITY WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH. NO USER FACILITY MEDWATCH WAS RECIEVED. G3: CONSUMER WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH. H6: CODE #400(OTHER): YIELDED JAWS
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE DEVICE WAS SPITTING CLIPS. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: YIELDED JAWS. VISUAL INSPECTIONS & RESULTS: CLIP IN JAWS; A NO B YES. DAMAGED JAWS; A YES B NO. DAMAGED FEED BAR, DAMAGED HANDLE SHROUDS, DAMAGED TIP SHROUDS, DAMAGED TRIGGER, DAMAGED TUBE, AND DAMAGED WELD SEAMS; AB NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL; AB YES. FIRING: FEED CONFORM; A NO B YES. FIRING: FORM CONFORM; A NA B YES. JAWS: HOLD CLIP; A NO B YES. JAWS: INSIDE WIDTH AT TIPS; A .224 B .176. LOCKOUT FUNCTIONAL; AB YES. NUMBER OF CLIPS FED AND FORMED; A 6 EJECTED. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS OF INSTRUMENT A HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. INSTRUMENT B WAS RETURNED WITH NO PRELOAD OF THE JAW AGAINST THE TOP SHROUD. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION. A) IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. B) A MODIFIED TOP SHROUD FROM REVISED TOOLING AND A LOWER SHROUD FROM A NEW TOOL WERE IMPLEMENTED TO MAINTAIN JAW PRELOAD AGAINST THE TOP SHROUD. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
AN UNKNOWN END CONSUMER WAS DRIVING A POWERED SCOOTER DOWN A HILL. WHEN HE ATTEMPTED TO STOP, THE ELECTROMECHANICAL BRAKE FAILED TO OPERATE AND STOP THE SCOOTER. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION GIVEN.
EVAL OF THE RETURNED DEVICE SHOWS THAT THE ELECTRONICS WERE MODIFIED AFTER IT LEFT CO'S FACILITY. AS MADE, THE DEVICE WOULD GO FORWARD WHEN THE RH THUMB LEVER WAS DEPRESSED. AS RECEIVED, WAS LH FORWARD. IT WAS LEARNED THAT THE OWNER'S SON CHANGED WIRING W/O INPUT FROM THE DEALER OR MFG. WHEN CHANGING THE WIRING, THE MODULE COVER WAS PRIED OVER, BENDING THE BRACKET THAT SUPPORTS THE POTENTIOMETER THAT IS SET AT NEUTRAL AND ALLOWS THE ELECTRO-MECHANICAL BRAKE TO SET AND HOLD OR STOP THE SCOOTER. NO PRODUCT MALFUNCTION OR DEFECT. FAILURE IS DUE TO UNAUTHORIZED TAMPERING OF CONTROLS. END CONSUMERS ARE CAUTIONED THAT THEY ARE TO SEEK AUTHORIZED DEALERS TO REPAIR/REWORK ANY OF THE ELECTRONICS OF THIS DEVICE. WHEN WIRING WAS PLACED BACK IN ITS ORIGINAL CONFIGURATION AND THE BRACKET WAS STRAIGHTENED, THE UNIT MET ITS ORIGINAL MODE OF OPERATION AND THE BRAKE STOPS AND HOLDS THE DEVICE AS IT IS INTENDED TO DO. IS FREQUENCY OF OCCURRENCES OF THIS EVENT ADDRESSED IN DEVICE LABELING?N. IS FREQUENCY GREATER FOR THIS EVENT THAN USUAL?Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING?Y. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL?Y.
A PERSON WAS STRUCK BY A LEVER THAT LOCKS THE FILM MAGAZINE IN THE UPRIGHT CHEST STAND. HE ALLEGEDLY RECEIVED A SMALL CUT OVER THE RIGHT EYE.
DURING RESECTION OF BILATERAL HAGLIN'S DEFORMITY, SURGEON LEANED ON ELECTROSURGICAL PENCIL THUS ACTIVATING IT. PENCIL BURNED THROUGH SURGICAL DRAPE AND BURNED PT'S POSTERIOR THIGH (R) ABOVE POPLITEAL SPACE. BURN WAS APPROX. 2-3CM LONG AND 1-2CM DEEP. ANOTHER SURGEON (GENERAL SURGEON) WAS CALLED TO CONSULT. AREA WAS REPREPPED AND DRAPED. BURNED AREA WAS EXCISEDAND SKIN STITCHED CLOSED. DRY STERILE DRESSING APPLIED.
THE CUSTOMER DID NOT RETURN THE PENCIL TO CO FOR EVAL. THE LOT HISTORY WAS SEARCHED AND NO PERTINENT ENTRIES WERE FOUND. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY.
A BALLOON WAS USED TO SUCCESSFULLY DILATE A ONE YEAR OLD STENOSED STENT IN THE SUBCLAVIAN VEIN. AT THE COMPLETION OF THE PROCEDURE THE BALLOON BURST AND UPON WITHDRAWAL THROUGH AN INTRODUCER SHEATH THE BALLOON DETACHED. RETRIEVAL OF THE BALLOON SEGMENT UTILIZING A SNARE WAS UNEVENTFUL. THERE WERE NO PT COMPLICATIONS INVOLVED. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVER-PRESSURIZATION OR USE IN A CALCIFIED LESION. DILATATION OF A STENOSED STENT MAY RESULT IN CONTACT WITH A SURFACE THAT COULD DAMAGE THE BALLOON MATERIAL. THESE CIRCUMSTANCES MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, WITHOUT EVALUATING THE DEVICE CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
PT WAS OPERATED ON 8/9/96 FOR C1-C2 FUSION. FOLLOW-UP X-RAYS REVEALED BROKEN CABLE. THE PT WAS RE-OPERATED ON FOR REMOVAL OF THE BROKEN CABLE ON 9/12/96.
DEVICE IS BEING RETAINED BY USER FACILITY. UNABLE TO PERFORM EVAL.
CATHETER WAS USED DURING AN ALCOHOL ABLATION PROCEDURE. THE ALCOHOL WAS INJECTED INTO THE PT VIA THE CATHETER AND RETAINED FOR A PERIOD OF TIME. UPON WITHDRAWAL THE CATHETER WAS NOTED TO HAVE TORN AND FRAGMENTED. THE BROKEN SEGMENT WAS RETRIEVED SUCCESSFULLY WITH FORCEPS. ANOTHER CATHETER WAS PLACED AND THE PT CONDITION IS FINE. THIS DEVICE IS A DRAINAGE CATHETER AND THE DIRECTIONS FOR USE OUTLINE APPROPRIATE USAGE OF THIS DEVICE. CO BELIEVES NON INDICATED USE OF THIS DEVICE CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. WHEN AND IF THE PRODUCT IS REC'D AND EVALUATED, A SUPPLEMENTAL MW FORM WILL BE FORWARDED UNDER THE ABOVE SEQUENCE NUMBER. CO'S DIRECTIONS FOR USE STATE: "THIS CATHETER IS DESIGNED FOR EXTERNAL OR INTERNAL PERCUTANEOUS DRAINAGE OF THE BILIARY SYSTEM".
DURING REMOVAL OF SENSOR, THE CATHETER SNAPPED OFF LEAVING PORTION INSIDE PT'S SKULL. DID NOT SHOW UP ON X-RAY. VISUAL, NON-INVASIVE EXPLORATION DONE.
ATTEMPTS TO CONTACT CUSTOMER FOR RETURN OF THIS DEVICE HAVE BEEN UNSUCCESSFUL. THE DEVICE HAS NOT BEEN RETURNED TO CO FOR EVAL, AND CO MUST CONCLUDE AT THIS TIME THAT THE UNIT IS UNAVAILABLE.
ON 8/26/96, CO WAS INFORMED ON A DEATH CERTIFICATE THAT THE PT HAD EXPIRED DUE TO VENTRICULAR TACHYCARDIA. IT IS UNK IF THE DEVICE WAS EXPLANTED AND WILL BE RETUNED TO CO FOR ANALYSIS.
F.2, 4, 11: THE USER FACILITY HAS BEEN UNABLE TO PROVIDE CO WITH THE INFO.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS A MALFUNCTION WHERE A DEVICE WAS FOUND TO CONTAIN AN INVALID CALIBRATION CODE. IT IS BELIEVED THAT THIS WAS NOT A DEVICE MALFUNCTION, BU RATHER WAS A USER ERROR IN THAT THE USER UNINTENTIONALLY RECALIBRATED THE DEVICE. AS SUCH, THE CO HAS MODIFIED ITS LABEL COPY TO HIGHLIGHT THE POSSIBLE ERROR. NO INJURIES WERE REPORTED IN THE FIELD.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING?N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL?N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING?N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL?N. 510K #: K944195
ASSISTANT PICKED UP A CUP WITH THE STERILIZER IN IT AND SPILLED SOME OF IT IN HER EYE. EYE WASH USED FOLLOWING INCIDENT. EYE PROTECTION WAS NOT BEING WORN.
EYE IS OK -DR. SAID SHE HAD SLIGHT CHEMICAL IRRITATION. -VISION IS 20/25.
THE CATHETER WAS REMOVED FROM THE PTS VASCULAR SYSTEM. THIS INCIDENT WAS ORIGINALLY REPORTED TO FDA ON USP#1009669.
ACCIDENTALLY DROPPED INSTRUMENTS ONTO TRAY OF STERILIZER AND SPLASHED SMALL AMOUNT (FEW DRPS) INTO RIGHT EYE. SHE IMMEDIATELY FLUSHED WITH WATER AT EYEWASH STATION AND WENT TO DR FOR EVALUATION. NO EYE PROTECTION WORN AT TIME OF INCIDENT.
LABEL STATES EYE PROTECTION SHOULD BE WORN.
THE DEVICE WAS REMOVED AS THE "RESERVOIR HAD PERFORATED THE BLADDER". THE RESERVOIR, PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
THE LIMITED INFO REC'D INDICATES DEVICE FUNCTION WAS NOT RELATED TO THIS OCCURRENCE. REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN REC'D. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE REC'D QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. HOWEVER, BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT THAT THE RESERVOIR HAD PEFORATED THE BLADDER, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SURGICAL INTERVENTION. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SVC.
CAUTERY UNIT CAUSED APPARENT BURN TO SCLERA/CONJUNCTIVA. PHYSICIAN STATED PT RECEVIED INCREASE SWELLING WHICH REQUIRED MORE FREQUENT USE OF SAME (USUALLY POST-OP) EYE DROPS. PT'S ASTIGMATISM SLIGHTLY WORSE POST-OP, BUT CORRECTABLE WITH GLASSES.
A PHONE CONVERSATION WITH "USER FACILITY CONTACT PERSON" REVEALED THAT UNIT WAS STILL IN SVC AND COULD NOT BE RETURNED TO CO FOR EVAL.
RN DISCOVERED IV TUBING BROKEN OFF IN RED LEG OF CATHETER. IV NURSE REPAIRED LEG AND DISCOVERED RED AND WHITE LEGS COMMUNICATE WITH EACH OTHER. PT'S MD (PRIMARY) WAS AWARE OF CONDITION IN FEBRUARY & DYE STUDY DONE 3/5/96 WITHOUT EVIDENCE OF COMMUNICATION. PT HAS HAD MULTIPLE EPISODES OF SEPSIS BY THIS REPORT. INFECTIOUS DISEASE MD STATES: CAUSE MAY BE CATHETER BUT MAY BE SOMETHING ELSE ALSO. (PT HAS AIO5). CATHETER WAS REMOVED BY SURGEON WITH DIFFICULTY. CATHETER BROKE APART DURING EXPLANTATION. ALL PIECES RECOVERED WITHOUT PT INCIDENT.
THE CAUSE OF THE REPORTED EVENT WAS TRACED TO THE SETTING OF THE OVERPRESSURE RELIEF VALVE OF THIS UNIT. THE REPORTING HOSPITAL HAD THIS VALVE SET AT APPROX 45CMH2O. THIS SETTING WAS TOO LOW FOR THIS PATIENT. THEREFORE, PART OF THE DELIVERED BREATH WAS DIVERTED TO ATMOSPHERE AND PART WAS DELIVERED TO THIS PATIENT. THIS UNIT WAS EVALUATED BY THE MANUFACTURER AND WAS VERIFIED TO OPERATE WITHIN SPECIFICATIONS. THERE WAS NO MALFUNCTION OF THIS UNIT.
THE DEVICE HAD BEEN "TORN UP" DURING REMOVAL FROM THE PT AND HAD BEEN DISCARDED AT THE HOSPITAL.
THE DEVICES WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON A 450 LB PT. THREE 512X TROCARS AND ONE 512B BROKE DURING THE CASE. REP REPORTS TROCARS WERE UNDER EXTREME STRESS DURING THE PROCEDURE DUE TO TORQUING TO REACH THE GALL BLADDER. THERE WAS NO CONSEQUENCE TO THE PT.
CONCLUSION: RECORD PURPOSES ONLY:  NO ANALYSIS WAS PERFORMED SINCE NO INSTRUMENT WAS RECEIVED. THE INFO YOU HAVE PROVIDED HAS BEEN NOTED AND SHARED WITH THE APPROPRIATE MANUFACTURING PERSONNEL.
ON 7/16/96, PRODUCT WAS USED FOLLOWING A PTCA PROCEDURE AND HEMOSTASIS WAS ACHIEVED. LATER A HEMATOMA STARTED TO FORM. HEMOSTASIS WAS ACHIEVED FOLLOWING 10 MINUTES OF MANUAL COMPRESSION. LATER THE HEMATOMA STARTED GROWING AGAIN. A CLAMP WAS APPLIED FOR 8 HRS. HEMOSTASIS WAS ACHIEVED. PT REQUIRED TRANSFUSION. ON 7/30, PT WAS ADMITTED TO HOSP WITH SWELLING AND SANGUINOUS DRAINAGE. NO CULTURES WERE DONE. PT WAS TREATED WITH ANTIBIOTICS AND DISCHARGED 8/2 WITH NOT FURTHER COMPLICATIONS.
CODE 86: EVALUATION OF EVENT BASED ON MFG AND QC PROCEDURES, HISTORY OF DEVICE AND CONTENT OF THIS EVENT DESCRIPTION. REGARDING THE HEMATOMA: THE PHYSICIAN FELT THAT THE HEMATOMA OCCURRED BECAUSE HE HAD NOT DELIVERED THE COLLAGEN ACCURATELY OVER THE ARTERIAL PUNCTURE SITE. IN ADDITION, HEMATOMAS ARE NOT UNCOMMON FOLLOWING CARDIAC PROCEDURES. REGARDING THE INFECTION: THE INFECTION CAN NOT BE CONFIRMED, SINCE NO CULTURE WAS DONE. LOCALIZED FOREIGN BODY REACTION COULD HAVE CAUSED THE SWELLING AND SANGUINOUS DRAINAGE. IN ADDITION, THE SANGUINOUS DRAINAGE COULD HAVE BEEN THE RESULT OF THE BREAKDOWN OF THE COLLAGEN.
PORT WAS MALFUNCTIONING IT WAS REMOVED AND A LATERAL SLIT WAS NOTICED IN THE CATHETER.
DURING CRANIOTOMY, DEVICE CAUSED LARGE DURAL TEAR.
A REVIEW OF MFG HISTORY RECORDS FOR THIS LOT REVEALED NO DISCREPANCIES. THE DEVICE WAS VISUALLY INSPECTED. HARDENED CASE DEBRIS WAS NOTED ON THE UNIT. THE DEBRIS WAS REMOVED AND THE UNIT WAS FUNCTIONALLY TESTED. THE DEVICE PERFORMED CORRECTLY FOR TEN TEST HOLES. THE REPORTED FAILURE COULD NOT BE REPEATED. THE INTERNAL COMPONENTS APPEARED NORMAL.
THE DEVICE WAS REMOVED DUE TO A "PINHOLE SIZED LEAKAGE SITE IN RESIPUMP". THE RESIPUMP ONLY WAS REMOVED AND REPLACED.
EVAL AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE COMPONENTS. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SVC. IF AND WHEN THE REQUESTED INFO AND DEVICE IS REC'D, QA WILL FILE AN ADDENDIUM TO THIS REPORT.
IAB IN USE FOR 3 DAYS CABG PERFORMED. BLOOD NOTED IN THE TUBING THE NEXT MORNING. REQUIRED SURGICAL REMOVAL DUE TO THROMBUS.
H-10 EVALUATION IN PROCESS. H-11 ALL UNK INFO REQUESTED NOT REC. H.11 -SECTION F PROVIDED BY MFR. H.11 SECTION F.10 DEVICE CODE 1052 LABELED. INTERNAL # 061996080044.
ON 7/30/96, FOLLOWING DIAGNOSTIC ANGIOGRAPHY, PRODUCT WAS USED. FOLLOWING DEPLOYMENT OF THE FIRST PLUG, PHYSICIAN NOTICED A KINK IN THE SHEATH. HE ATTEMPTED TO DEPLOY THE SECOND PLUG AND COULD NOT. THE SHEATH SEPARATED FROM THE HUB. WHEN THE CLINICAL EDUCATION SPECIALIST WAS INFORMED OF THE EVENT, HE ASKED ABOUT THE SHEATH. THE PHYSICIAN WAS NOT SURE WHERE THE SHEATH WAS. THE CLIN. ED SUGGESTED THE PT BE EXAMINED. ON 8/1/96 SHEATH WAS FOUND IN THE PT. IT WAS REMOVED UNDER LOCAL ANESTHESIA WITH NO CLINICAL COMPLICATIONS.
CODE 86: EVALUATION OF EVENT BASED ON MFR AND QC PROCEDURES, AND HISTORY OF THIS TYPE OF FAILURE. THE PRODUCT SHEATH IS DESIGNED AND QC TESTED TO DELIVER COLLAGEN THROUGH AN UNRESTRICTED SHEATH. THE SHEATH CAN KINK WHEN LEVERAGE OR PRESSURE IS PLACED ON THEM. A KINK CAUSES A RESTRICTION IN THE SHEATH WHICH IMPEDES THE PASSAGE OF COLLAGEN. CONTINUED ATTEMPTS TO DELIVER THE COLLAGEN CAUSES EXCESSIVE STRESS AND THE SHEATH IS FORCED TO SEPARATE FROM THE HUB. THE IFU WARNS THE USER TO AVOID KINKS AND IF EXCESSIVE RESISTANCE IS FELT THE PPRODUCT PROCEDURE SHOULD BE ABORTED. THE USER SHOULD ENSURE THAT THE WHITE SHEATH IS INTACT WITH THE COLORED HUB.
THE REPORTER FROM THE USER FACILITY DID NOT KNOW THE LOT NUMBER FOR THE DEVICE, WHEN THE DEVICE HAD BEEN IMPLANTED, OR WHAT WAS BEING INFUSED THROUGH THE DEVICE. THE DEVICE WAS UNABLE TO BE EVALUATED, AS IT IS BEING RETAINED BY THE HOSPITAL.
PERFORATOR DID NOT STOP. MADE A BONE PUNCH-OUT.
THERE WERE NO DISCREPANCIES NOTED IN THE MFG HISTORY RECORDS FOR THIS LOT. THIS UNIT WAS VISUALLY INSPECTED. HARDENED CASE DEBRIS AND RUST WAS NOTED. THE OUTER DRILL CUTTING EDGES HAD BEEN DULLED BY A HARD MATERIAL SUCH AS METAL. THE DEBRIS AND RUST WERE REMOVED AND THE UNIT WAS REBUILT. FUNCTIONAL TESTING WAS SATISFACTORY FOR TEN TEST HOLES ALTHOUGH THE CUTTING ACTION WAS SOMEWHAT SLOW DUE TO THE DULL CONDITION. THE REPORTED FAILURE COULD NOT BE REPEATED. INTERNAL COMPONENTS APPEARED NORMAL.
THE STERILIZATION RECORDS FOR THE INDICATED LOT WERE REVIEWED AND FAVORABLE TEST RESULTS WERE SEEN FOR STERILITY AND PYROGENICITY. THIS REPORT WAS SUBMITTED TO THE FDA AS USP#1009770.
THE DEVICE WAS REMOVED DUE TO "LEAKAGE". SECONDARY TO "A TUBING BREAK ON THE RIGHT SIDE NEAR THE PUMP".
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 6/11/87 AND REVISED ON 8/28/96 DUE TO A "TUBING BREAK ON RIGHT SIDE NEAR THE PUMP" AND "LEAKAGE." REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES.
BOTH VALVES WERE PLACED IN THE SAME PT. EACH MALFUNCTIONED WITHIN 3 DAYS OF IMPLANTATION. "NOTE: SEE DEVICE MFGS REPORT 8031062-1996-2.
DEVICE HAS BEEN FORWARDED TO THE MFG SITE FOR EVAL. EVAL IS IN PROGRESS.
RN INSERTED PICC LINE FOR HOME IV ANTIBIOTIC USE. PT RETURNED TO ED FOR NAFCILLIN IV. MD DISCOVERED CATHETER HAD DISCONNECTED FROM METAL HUB. FLUOROSCOPY WAS EMPLOYED AND IT WAS FOUND THAT CATHETER HAD EMBOLIZED COMPLETELY INTO THE RIGHT VENTRICLE AND PULMONARY ARTERY. PT REQUIRED ADMISSION AND SUBSEQUENT TRANSFER TO ANOTHER FACILITY FOR REMOVAL. PICC CATHETER REMOVED INTACT AT OTHER FACILITY. (PERCUTANEOUS TRANSCATHETER CATHETER REMOVAL).
A SURGICAL REVISION WAS REQUIRED TO ADDRESS "AUTOINFLATION". A "FLUID ADJUSTMENT WAS MADE". THE CONNECTOR(S) ONLY WERE REMOVED AND REPLACED TO FACILITATE THE MODIFICATION.
PER THE AVAILABLE INFORMATION, THIS DEVICE WAS IMPLANTED ON 9/14/95 AND REVISED ON 8/28/96. THIS REVISION OCCURRED DUE TO A REPORTED AUTOINFLATION. THE ENTIRE DEVICE WAS NOT EXPLANTED. INSTEAD, A PIECE OF TUBING, A CONNECTOR, AND 20 CC OF FLUID WERE REMOVED ACCORDING TO A RETURNED QUESTIONNAIRE: THE PATIENT WAS CONCERNED ABOUT AUTOINFLATION TWO MONTHS AFTER IMPLANTATION, THE PATIENT USED THE DEVICE PRIOR TO 12-1-96, THE CYLINDERS WERE LEFT DEFLATED AT IMPLANT; THERE WAS NO FLUID LOSS FROM THE DEVICE, THE DEVICE WAS NOT FILLED OVER THE SUGGESTED VOLUME, AND THERE WERE NO CIRCUMSTANCES IN THE PATIENT'S HISTORY WHICH COULD HAVE CONTRIBUTED TO THIS OCCURRENCE. QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED COMPONENTS FOR EVALUATION. SINCE EXAMINATION OF THE COMPONENTS CAN NOT CONCLUSIVELY PROVE OR DISPROVE THE AUTOINFLATION, QA WILL ACCEPT THE PHYSICIAN'S OBSERVATION OF AUTOINFLATION AS THE REASON FOR REMOVAL. IN THE OPERATIVE NOTES THE PHYSICIAN NOTED THAT AFTER THE FLUID ADJUSTMENT, "THE PROSTHESIS WAS THEN DEFLATED AND OBSERVED FOR APPROXIMATELY FOUR MINUTES WITH NO EVIDENCE OF ANY AUTOINFLATION." THUS, QA CONCLUDES THAT THE DEVICE FUCNTION WAS NOT A CAUSE FOR THE REPORTED AUTOINFLATION.
BOTH VALVES WERE PLACED IN THE SAME PT. EACH MALFUNCTIONED WITHIN THREE DAYS OF IMPLANTATION. NOTE: SEE DEVICE MFGS REPORT 8031062-1996-01.
DURING PLACEMENT OF THE SHEATH INTRODUCER, THE PHYSICIAN HIT AN ARTERY CAUSING PT'S BLOOD PRESSURE TO DROP. THEY PUT PT ON BYPASS AND CHECKED THE PUNCTURED ARTERY. THEY FELT THE PUNCTURE WAS SMALL AND BLEEDING WOULD STOP. FOLLOWING SURGERY THEY REMOVED THE PT FROM BYPASS AND AGAIN THE BLOOD PRESSURE DROPPED. THEY FOUND THAT THEY HAD TRANSFIXED THE VEIN AND ARTERY,  AND PUNCTURED THE LUNG. THE PHYSICIAN ADMITTED THAT THE INCIDENT WAS HIS FAULT. THE PT RECOVERED.
THE REPORTER FROM THE USER FACILITY STATED THAT THE PROBLEM HAD BEEN TRACED TO ONE NURSE. THE NURSE WAS ASKED TO DEMONSTRATE HOW TO PUT ON THE CATHETER CONNECTOR AND THE NURSE DID NOT USE THE SUPPLIED LOCKING SLEEVE WHEN PLACING THE CONNECTOR. THE REPORTER STATED THAT THE STAFF WAS RETRAINED ON THIS PROCEDURE AND THAT THE FACILITY CONSIDERS THIS PROBLEM TO BE USER ERROR.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT REMOVAL DUE TO FAILURE OF THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SEPCIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED THAT THE FUSE WAS OPEN (THE DMM READS "OL" OR OPEN LINE). THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. THIS WAS THE SECOND PT TO BE RUN ON THIS MACHINE. AFTER IT WAS DETECTED THAT THE FIRST PT HAD A WEIGHT DISCREPANCY, THE FACILITY DID NOT RUN AUTOTEST. THE AUTOTEST FUNCTION IS DESIGNED TO VERIFY THE INTEGRITY OF THE MACHINE AND CAN DETECT THERMAL FUSE FAILURES. IF AUTOTEST HAD BEEN RUN AND FAILED, THE INCIDENT IN THIS REPORT WOULD HAVE BEEN AVOIDED. RPTR SPOKE WITH THE FACILITY COORDINATOR ABOUT THE NEED TO RUN AUTOTEST TO PREVENT MULTIPLE PT FAILURES. HE STATED THAT THEY WILL MAKE THAT A POLICY FOR FUTURE FAILURES. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL (P. 3-19, VERSION 1995/10) THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TRETAMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION. THE OPERATOR IS ALSO INSTRUCTED TO PREFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGH REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. HOWEVER, THE FACILITY'S FAILURE TO FOLLOW THE PROCEDURES AND GUIDELINES IN THE CS3 OPERATOR'S MANUAL CONTRIBUTED TO THE MACHINE FAILING ON MORE THAN ONE PT. THE MFR RECOMMENDS FOLLOWING THE SUGGESTIONS IN THE OPERATOR'S MANUAL. NO FURTHER REPORTING IS ANTICIPATED AT THIS TIME. THE MFR WILL CONTINUE TO MONITOR AND TREND.
DURING REMOVAL OF GUIDE WIRE FROM CVP CATHETER, SIGNIFICANT RESISTANCE WAS FELT. OUTER LAYER OF GUIDEWIRE UNRAVELED. THE CVP CATHETER WAS REMOVED. THE PROXIMAL PORTION OF GUIDE WIRE WAS CUT BY ANESTHESIOLOGIST AND THE DISTAL PORTION WAS SUTURED AT THE SKIN. ON CT SCAN, GUIDE WIRE WAS OBSERVED IN VENA CAVA FILTER. DISTAL PORTION OF CATHETER WAS REMOVED BY A CARDIOLOGIST UNDER FLUOROSCOPY. NO FURTHER UNTOWARD EFFECT TO PT.
THE DEVICE WAS REMOVED DUE TO "RIGHT CYLINDER EROSION". THE RIGHT CYLINDER ONLY WAS REMOVED AND THE REMAINING CYLINDER WAS "CAPPED OFF". THE CYLINDER REMOVED WAS NOT REPLACED.
QA REC'D THE RETURNED CYLINDER FOR EVAL. THERE ARE NO APPARENT ABNORMALITIES OBSERVED TO HAVE CONTRIBUTED TO THIS OCCURRENCE. HOWEVER, EVAL OF THE DEVICE WOULD NOT CONFIRM OR DISPROVE THE REPORT OF URETHRAL INTRUSION OR MIGRATION OF THE CYLINDER. THEREFORE, QA ACCEPTED THE PHYSICIAN DIAGNOSIS OF THIS AS THE CAUSE FOR INTERVENTION. THE INFO INDICATING THE REMAINDER OF THE COMPONENTS WERE LEFT IMPLANTED SUGGESTS THAT THESE COMPONENTS WERE DETERMINED TO BE FUNCTIONAL. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SVC.
10/13/95 PT HAD CATHETER INSERTED. ON 8/5/96 IT BECAME EVIDENT THAT THE CATHETER WAS NOT FUNCTIONING (CHEST X-RAY). WHILE THE RADIOLOGIST WAS READING THE FILM IT WAS NOTED THT THE CATHETER WAS BROKEN IN 2 PIECES; EACH APPROX. 15 CM LONG. IT WAS DECIDED BY THE PHYSICIAN THAT RADIOLOGY WOULD REMOVE THE PIECE THAT WAS LODGED IN THE VASCULAR SYSTEM.
DURING REMOVAL OF THE SPRING WIRE GUIDE FROM THE CATHETER RESISTANCE WAS ENCOUNTERED. THE OUTER COIL UNRAVELLED. THE CATHETER WAS REMOVED AND THE PROXIMAL PORTION OF THE WIRE GUIDE WAS CUT BY THE ANESTHESIOLOGIST AND THE DISTAL PORTION WAS SUTURED TO THE SKIN. ON CT SCAN, THE GUIDE WIRE WAS OBSERVED IN A VENA CAVA FILTER WHICH HAD BEEN PLACED TEN MONTHS PRIOR TO ADMISSION. THE DISTAL PORTION OF THE WIRE WAS REMOVED AND THERE WERE NO PT COMPLICATIONS.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THIS MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED THAT THE FUSE WAS OPEN (THE DMM READS "OL" OR OPEN LINE). THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. THIS WAS THE THIRD PT TO BE RUN ON THIS MACHINE. AFTER IT WAS DETECTED THAT THE FIRST AND SECOND PTS HAD A WEIGHT DISCREPANCY, THE FACILITY DID NOT RUN AUTOTEST. THE AUTOTEST FUNCTION IS DESIGNED TO VERIFY THE INTEGRITY OF THE MACHINE AND CAN DETECT THERMAL FUSE FAILURES. IF AUTOTEST HAD BEEN RUN AND FAILED, THE INCIDENT IN BOTH THIS REPORT AND CPF #0896273C3 COULD HAVE BEEN AVOIDED. RPTR SPOKE WITH THE FACILITY COORDINATOR ABOUT THE NEED TO RUN AUTOTEST TO PREVENT MULTIPLE PT FAILURES. HE STATED THAT THEY WILL MAKE THAT A POLICY FOR FUTURE FAILURES.
A CATHETER FRAGMENT MEASURING 6.45" WAS RETURNED FOR EVAL. INSPECTION OF THE FRAGMENT SHOWED THE BROKEN END OF THE TUBING HAD BEEN COMPRESSED AND FRACTURED AND WAS PERMANENTLY FLATTENED AND FLARED. UNDER MAGNIFICATION, THE SEVERED SURFACE TEXTURE APPEARED ROUGH AND GRANULAR. THE END OF THE BROKEN TUBING WAS PERMANENTLY DEFORMED INTO AN OVAL SHAPE AND ONE OF THE INSIDE CORNERS OF THE OVAL APPEARED TO BE PINCHED. THESE SIGNS ARE TYPICAL OF A CLAVICLE/1ST RIB COMPRESSION FRACTURE.
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROTHESIS WAS REVISED DUE TO AN "INFECTION" AND THAT STAPH EPIDERMIS ORGANISMS WERE DETECTED. NO SURGERY DATES WERE PROVIDED. REQUESTS FOR THE EXLANTED PROTHESIS AND FOR ADDITIONAL INFORMATION SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFORMATION HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFORMATION, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. HOWEVER, BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA ACCEPTS THE REPORT OF INFECTION AS THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE.
THE PORT WAS PLACED 5/16/96, FOR CHEMOTHERAPY. THE 3RD TIME THE PORT WAS FLUSHED, SWELLING WAS NOTED IN THE AREA AROUND THE PORT. AN X-RAY SHOWED THE CATHETER HAD BROKEN OFF FROM THE PORT. THE BROKEN END OF THE CATHETER FRAGMENT WAS DESCRIBED AS "JAGGED."
THE PHYSICIAN WHO IMPLANTED THE PORT STATED THE CATHETER HAD BROKEN OFF FLUSH WITH THE CATHETER LOCK. A SMALL PIECE OF THE CATHETER COULD BE SEEN UNDERNEATH THE CATHETER LOCK. THE DEVICE IS BEING RETAINED BY THE HOSP AND IS THEREFORE UNAVAILABLE FOR EVAL.
TOTAL HIP REVISION DUE TO RECURRENT DISLOCATION.
THE DEVICE WAS REMOVED DUE TO AN "INFECTION". THE PUMP AND ASSEMBLY KIT COMPONENTS ONLY WERE REMOVED AND REPLACED.
REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPANDED DEVICE OR ADD'L INFO BE REC'D, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. HOWEVER, BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA ACCEPTS THE REPORT OF INFECTION AS THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCES OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SVC.
IN PROCESS OF REMOVING CATHETER IT WAS NOTED THAT CATHETER WAS NOT COMPLETELY INTACT. PERCUTANEOUS REMOVAL ATTEMPTED VIA FEMORAL APPROACH - CATHETER FRACTURED AT ANOTHER POINT. PT WAS TRANSFERRED TO ANOTHER FACILITY AND CATHETER WAS REMOVED. TIP REMAINS IN LUNG. PT TOLERATED PROCEDURE AND WAS DISCHARGED.
THE PORT WAS IMPLANTED 2/7/96, ON THE PT'S RIGHT SIDE. DIFFICULTIES WITH INFUSTION WERE REPORTED, SO AN X-RAY WAS TAKEN WHICH WAS REPORTED TO SHOW SUBCUTANEOUS LEAKAGE. THE PORT WAS REMOVED AND REPLACED.
NO LEAKS WERE OBSERVED WHEN THE DISTAL TIP OF THE CATHETER WAS OCCLUDED. TENSION APPLIED ON THE CATHETER, AWAY FROM THE PORT CAUSED A MODERATE LEAK AT THE PORT/CATHETER CONNECTION. UNDER MAGNIFICATION, SERRATED MARKS AND CRACKS LIKE THOSE MADE BY HEMOSTATS WERE SEEN ON THE JOINT. THE PROXIMAL TIP OF THE TUBING WAS BUNCHED AND THERE WAS A SHORT TEAR IN THE SILICONE AS IT BECAME FLUSH WITH THE PORT STEM BASE. THIS INDICATES AN IMPROPER PORT-CATHETER CONNECTION.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRFILTRATION ) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED THAT THE FUSE WAS OPEN (METER READS "OL", OR OPEN LINE). THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH  CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P.3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND HE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: Y. SALES/SERVICE CONTACTED BY INVESTIGATOR?N. TRAINING REQUIRED?N.
THE PHYSICIAN REPORTED THAT THE CATHETER APPEARED TO HAVE BROKEN AT TEH CLAVICLE-FIRST RIB JUNCTION AND THEN FURTHER FRACTURED DURING REMOVAL.
THE PORT WAS ACCESSED AND FLUSHED NORMALLY. THE CATHETER WAS PRESSURIZED AND NO LEAKS WERE FOUND. THE TUBING WAS TACTUALLY INSPECTED AND NO ELONGATION WAS FOUND, BUT THE BROKEN END OF THE TUBING WAS COMPRESSED AND PERMANETLY FLATTENED  INTO AN OVAL SHAPE. THE INTERIOR WALLS OF THE LUMEN WERE COMPRESSED AND COLLAPSED, FORMING POINTS IN THE CORNERS. THESE SIGNS ARE TYPICAL OF A CLAVICLE FIRST RIB COMPRESSION FRACTURE. CAUSED BY THE MEDIAL PLACEMENT OF THE CATHETER.
THE PORT WAS IMPLANTED 7/17/96, ON THE LEFT SIDE FOR CHEMOTHERAPY. BEFORE THE FIRST INFUSION, THE ONCOLOGIST TOLD THE PT THAT THE PORT WAS LEAKING. AN X-RAY WAS TAKEN WHICH SHOWED A LEAK AT THE PORT-CATHETER CONNECTION. THE PORT WAS REMOVED.
THE CATHETER SHOWED NO SIGNS OF TENSILE ELONGATION OR WEAKNESS. THE SEPTUM HAD SOME NEEDLE STICK MARKS THAT APPEAR TO HAVE CORED THE SEPTUM. THESE CAN BE CAUSED BY USING HYPODERMIC NEEDLES, WHICH IS WARNED AGAINST IN THE INSTRUCTIONS FOR USE. THE PORT AND CATHETER FLUSHED AND ASPIRATED NORMALLY. THE CATHETER WAS PRESSURIZED, WHICH CAUSED BULGING OF THE SEPTUM AND BALLOONIZING OF THE CATHETER, BUT NO LEAKS WERE DETECTED IT IS POSSIBLE A FIBRIN SHEATH MAY HAVE FORMED AND APPEARED AS A LEAK ON AN X-RAY.
THE DR CLAIMS THAT DURING AN ABDOMINAL AORTIC ANEURYSM PROCEDURE, BLEEDING OCCURRED (QUANTITY UNKNOWN) FROM PART OF THE GRAFT WALL, ANOTHER GRAFT WAS USED IN ITS PLACE. THE PT'S CONDITION IS FAVORABLE.
NOTE: CODE 86: THE QUALITY CONTROL TEST RECORDS FOR THIS BATCH WERE REVIEWED. CODE 100: THE  QUALITY CONTROL TEST RECORDS FOR THIS BATCH WERE FOUND TO BE NOT ATYPICAL - NO SIMILAR COMPLAINTS AGAINST THIS BATCH. CODE 200: SEE PATHOLOGIST'S REPORT (ATTACHED)GROSS DESCRIPTION: RECEIVED IN FORMALIN IS A SEGMENT OF CRIMPED VASCULAR GRAFT WHICH MEASURES 4.7 CM IN LENGTH BY 1.7 CM IN DIAMETER. THE SURFACES ARE CLEAN AND THE SPECIMEN APPEARS TO HAVE NOT BEEN IMPLANTED. REP SECTIONS ARE EMBEDDED UNDER MD-912 AND MD-913. MICROSCOPIC DESCRIPTION: SEGMENTS OF A VASCULAR GRAFT WITH COLLAGEN COATING ARE IDENTIFIED. THE INTEGRITY OF THE VASCULAR GRAFT IS INTACT. THE COLLAGEN COATING IS PRESENT ON THE LUMINAL AND PERIADVENTITIAL SURFACES AS WELL AS WITHIN THE INTERSTICES OF THE VASCULAR GRAFT. NO LOSS OF INTEGRITY OF THE COLLAGEN COATING IS IDENTIFIED. NO EVIDENCE OF IMPLANTATION IS IDENTIFIED. SUMMARY: AN INTACT VASCULAR GRAFT WITH AN INTACT COLLAGEN COATING IS IDENTIFIED. NO EVIDENCE OF IMPLANTATION IS IDENTIFIED.
THE CATHETER WAS PLACED APPROX. 11/15/91 FOR CHEMOTHERAPY FOR LYME DISEASE. IN MARCH 1994, A FRAGMENT FROM THIS CATHETER WAS DISCOVERED IN THE PT'S CHEST AFTER MAMMOGRAPHY.
THE PORT WAS IMPLANTED 10/23/95, FOR CHEMOTHERAPY. IT WAS REPORTED THAT THE CATHETER RUPTURED 6 CM DISTAL TO THE PORT/CATHETER CONNECTION. THE PORT WAS REMOVED AND DISCARDED.
THE GRAFT WAS IMPLANTED AS AN AORTO-ILIAC BYPASS GRAFT. WHEN THE CLAMP WAS RELEASED, THE ILIAC WALLS LEAKED APPROX. 2600MLS OF BLOOD. THE GRAFT WAS MADE BLOOD-TIGHT BY DECLAMPING AND RECLAMPING AND ADMINISTERING PROTAMINE AT THE CLAMP SITE. THE GRAFT WAS LEFT IN. THE PT, WHILE STILL IN THE O.R., DEVELOPED A MYOCARDIAL INFARCTION AND BECAME UNSTABLE, BUT EVENTUALLY STABILIZED. THE PT'S CONDITION IS FINE, AND HE IS BEING RELEASED FROM THE HOSP. THE UNUSED SECTIONS OF THE GRAFT WERE DISCARDED BY THE O.R. STAFF AT THE HOSP.
SINCE THE SECTIONS OF THE GRAFT THAT WERE UNUSED HAD BEEN DISCARDED BY THE O.R. STAFF AT THE HOSP, AN EVALUATION OF THE PRODUCT INVOLVED IN THIS COMPLAINT IS NOT POSSIBLE. A REVIEW OF THE BATCH RECORDS SHOW THEY ARE NOT  ATYPICAL AND THERE ARE NO SIMILAR COMPLAINTS AGAINST THIS BATCH. NOTE: ITEMS MARKED "NI" INDICATE NO INFO AT THIS TIME, BUT IF INFO BECOMES AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR.
NOTE: ITEMS MARKED "NI" INDICATE NO INFO AT THIS TIME. IF INFO BECOMES AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR.
ON 9/30/96, CO LEARNED THAT, ACCORDING TO THE DR, THE ACTUAL AMOUNT OF BLOOD LOSS WAS APPROX 8O0 CC AND THAT THE BLEEDING STOPPED ON ITS OWN WITHOUT TREATMENT.
THE PORT WAS IMPLANTED 4/22/96, FOR IV/IG ACCESS. THE PT REPORTED THE DR WAS UNABLE TO ASPIRATE OR INFUSE THE PORT AND THAT THE PORT POCKET DID NOT HEAL PROPERLY. THE PT REPORTED RECEIVING UROKINASE THREE TIMES IN AN UNSUCCESS ATTEMPT TO DECLOT THE PORT.
THE PT SAID THERE WAS A "SMALL HAIRLINE TYPE BURN" THAT WENT FROM THE PORT INTO THE AREA OF HER LEFT BREAST. THE PORT WAS REMOVED AND REPLACED ON 6/20/96. THE SURGEON'S OPERATIVE RECORD INDICATES A CUT IN THE CATHETER WAS OBSERVED 1" DISTAL TO THE PORT WHEN THE PORT WAS REMOVED. THE PORT WAS DISCARDED BY THE HOSP PATHOLOGY DEPT AND WAS NOT AVAILABLE FOR EVAL.
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROTHESIS WAS IMPLANTED AND REMOVED ON 8/29/96 DUE TO "DEFLATION". IN THE RECEIVED INFORMATION THE PHYSICIAN STATED THAT AFTER PERFORMING A REVISION SURGERY TO EXCHANGE THE RESIPUMP OF THIS PATIENT'S DEVICE, AND AFTER CLOSING THE PATIENT, DEFLATION OF THE DEVICE WAS NOTED. THEREFORE THE PATIENT WAS RE-OPENED, AND THE ENTIRE DEVICE WAS REMOVED AND REPLACED. QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PRECLUDED FROM COMMENTING ON THE CONDITION OF THE PROSTHESIS. SHOULD THE EXPLANTED DEVICE BECOME AVAILABLE, OR ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURE.
PER THE INFORMATION PROVIDED TO US BY PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO "DEFLATION". AS REPORTED TO US, THE PATIENT WAS UNDERGOING A REVISION OF A MARK II ORIGINALLLY IMPLANTED IN 1992. IT WAS OBSERVED AT THIS TIME THAT THERE WAS LEAKAGE FROM TEH RESIPUMP COMPONENT (SEE MFR REPORT #1996-2125050-0466). THE PHYSICIAN LEFT THE CYLINDER(S) INPLACE AND REPLACED THE RESIPUMP ONLY. UPON CLOSING THE PATIENT, HE CYCLED THE DEVICE AND DISCOVERED "DEFLATION OF THE DEVICE". THE PHYSICIAN REOPENED THE PATIENT, REMOVED THE ENTIRE DEVICE AND REPLACE IT WITH ANOTHER MENTOR 2-PIECE INFLATABLE PENILE PROTHESIS.
DURING AN INCIDENT INVOLVING A 58 YR OLD MALE IN CARDIAC ARREST, THE DEVICE REPORTEDLY SHUT ITSELF OFF AFTER THE FOURTH SHOCK. A NEW BATTERY WAS PLACED IN THE DEVICE AND IT WOULD NOT POWER ON. THE PT WAS TRANSPORTED TO A HOSP. A DEFIB WAS USED IN THE AMBULANCE TO SHOCK THE PT. CUSTOMER DID NOT KNOW PT OUTCOME.
THE RETURNED DEVICE WAS EVALUATED BY A SERVICE TECHNICIAN WHO VERIFIED THE REPORTED COMPLAINT. A POWER TRANSISTOR WAS FOUND TO BE SHORTED, AND A 15 AMP FUSE WAS FOUND IN AN OPEN CONDITION DUE TO THE TRANSISTOR FAILURE. THE BLOWN FUSE CAUSED THE DEVICE TO TURN OFF AND REMAIN OFF. THIS IS A SAFETY FEATURE OF THE DEVICE TO PREVENT FURTHER DAMAGE TO THE DEVICE. THE FUSE AND POWER TRANSISTOR WERE REPLACED AND PROPER OPERATION WAS VERIFIED.
THE PORT HAD "MALFUNCTIONED" AND HAD TO BE REMOVED FROM THE PT. ADD'L INFO RECEIVED ON 8/26/96, INDICATED THAT THE CATHETER HAD BURST 2 CM FROM THE PORT CONNECTION.
A SPLIT IN THE CATHETER TUBING WAS SEEN BETWEEN THE 3 CM AND 10 CM MARKS. THE OPENING WAS APPROX 6" LONG. THE PROXIMAL LUMEN OF THE PORT WAS OCCLUDED WHEN IT WAS FLUSHED. AS PRESSURE WAS HELD, BLOOD RESIDUE WAS EXTRUDED THROUGH THE SPLIT IN THE TUBING. A TACTILE EXAM OF THE TUBING SHOWED WEAKNESS ONLY AT THE BURST SITE. UNDER MAGNIFICATION, THE SLIT SURFACE WAS SEMI-GLOSSY BUT ROUGH, WITH NO CROWS-FEET. THIS INDICATED A BURST FAILURE POSSIBLY CAUSED BY OVERPRESSURIZATION OF AN OCCLUDED LUMEN.
DURING PT TRANSPORT FROM THE OPERATING ROOM, THE "BATTERY ON LOW" ALARM OCCURRED. THE BATTERIES WERE ABOUT THREE YEARS OLD AND THE MAINTENANCE SCHEDULE CALLS FOR REPLACEMENT EVERY TWO YEARS. ALSO, THERE WAS AN INTERMITTENT AUDIO ALARM WHICH IS BEING EVALUATED. THERE WAS NO IMPACT TO THE PT.
THE CUSTOMER REPORTED A SURGICAL ADMISSION FOR UNDESCENDED TESTICLE AND PHIMOSIS. UROLOGY PERFORMED RIGHT INGUINAL HERINORRHAPY, RIGHT ORCHIECTOMY AND CIRCUMCISION. PT WAS READMITTED BECAUSE OF CLEAR YELLOW FLUID DRAINING FROM THE WOUND. SURGICAL INTERVENTION REQUIRED FOR REPAIR OF BLADDER PERFORATION AND REPAIR OF RIGHT INGUINAL FLOOR. SURGEONS THINKS THAT WHEN HE WAS DISSECTING AND LOOKING FOR THE TESTICLE, THE BOVIE TIP MUST HAVE TOUCHED THE BLADDER.
THE CUSTOMER DID NOT RETURN THE SAMPLE FOR EVAL. THE LOT HISTORY WAS REVIEWED AND NO PERTINENT ENTRIES WERE RECORDED. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO CO WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLELAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY.
DARK SPECK FOUND IN VIAL. HAVE ALSO SEEN IN OTHER LOTS.
DEVICE WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED THE SURGEON WAS USING THE BLUNT EDGE OF THE DEVICE TO COAPTIVELY COAGULATE THE IP LIGAMENT. IN DOING SO, THE SHEAR EDGE OF THE BLADE TRANSECTED THE EXTERNAL ILIAC ARTERY. THE PT WAS OPENED. THR DEVICE WAS UTILIZED TO COAGULATE THE DISTAL END OF THE ARTERY. THE HEART TEAM WAS CALLED IN TO PLACE A GRAFT IN THE ILIAC ARTERY TO REJOIN THE TWO ENDS. NO TRANSFUSION WAS REQUIRED. PT REPORTEDLY DOING WELL AT THIS TIME.
A1,2,3,4;B6,7;D10: INFO NOT PROVIDED DURING INITIAL CONTACT. FOLLOW UP LETTER SENT TO FACILITY REQUESTING ADD'L INFO. D5,6; H3,4,6;G4: ADDED ADD'L INFO. D6; DEVICE RETURNED WITH NO LOT ID. CONCLUSION: NO ANALYSIS COULD BE PERFORMED SINCE NO INSTRUMENT WAS RECEIVED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THIS EVENT TO OCCUR. COMMENTS: CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCT.
A FIVE DAY OLD ACTIVE INFANT WEIGHING 2050 GMS WAS PLACED IN AN INCUBATOR THROUGH THE FRONT ACCESS PANEL. THE ACCESS PANEL LATCHES WERE INADVERETENTLY NOT ENGAGED. SHORTLY THEREAFTER, THE INFANT KNOCKED OPEN THE ACCESS PANEL AND FELL TO THE FLOOR. SUBSEQUENT INVESTIGATION REVEALED TWO PROBLEMS. 1. THE STAFF DID NOT CHECK THE ACCESS PANEL DETENT OPERATION ON A REGULAR BASIS. 2. THE STRIKER PLATES ON THE ACCESS PANEL HAS NO ACCESS PANEL DETENT. IT IS UNKNOWN IF THE DETENT WOULD HAVE PREVENTED THIS INCIDENT. OF THE SEVEN UNITS IN THE FACILITY, FIVE HAD WORN STRIKER PLATES AND EFFECTIVELY NO ACCESS PANEL DETENT. THE INFANT WAS NOT INJURED IN THIS INCIDENT, BUT THE POSSIBILITY EXISTS FOR PT INJURY IN THIS TYPE OF INCIDENT.
LENS WAS NOTED TO HAVE A SCRATCH ON THE OPTIC PRIOR TO IMPLANTATION. THE LENS WAS NEVER INSERTED INTO THE PT'S EYE BUT REPORTER BELIEVED THERE WAS THE POTENTIAL FOR SERIOUS INJURY IF THE LENS HAD BEEN INSERTED OR IF THIS WERE TO RECUR IN THE FUTURE.
THE LENS WAS CONFIRMED TO HAVE A SCRATCH ON THE OPTICAL SURFACE. LENS WAS COATED WITH WHAT APPEARED TO BE BLOOD AND CLINICAL SOLUTION WHICH INDICATES CUSTOMER HANDLING. A SCRATCH OF THIS TYPE WOULD NOT HAVE PASSED THE COSMETIC CRITERIA OF THE INSPECTION. REPORTER WOULD ONLY PROVIDE INFO WHICH HAS BEEN DETAILED ON THIS REPORT FORM. THE MFR'S INTERNAL REFERENCE NUMBER IS 96L3859. THIS INFO IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT MFR'S LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
A FREE FLOW AFTER THE TRANSFER SET WAS INSTALLED AND BEFORE THE UNIT WAS PROGRAMMED. SINCE THE SET HAD BEEN DISCARDED THE REPORTER HAD THE USER INSTALL ANOTHER SET PER HIS DIRECTIONS, WHICH DID NOT RESULT IN FREE FLOW. SINCE THE ISSUE WAS RESOLVED BY TELEPHONE THE UNIT WAS NOT SWAPPED. NO PT INVOLVEMENT.
SECTION F COMPLETED BY CO, BASED ON INFO OBTANED FROM REPORTER. H3. DEVICE NOT RETURNED-ISSUE RESOLVED BY TELEPHONE USER ERROR.
THE FACILITY HAD RECEIVED THE DEVICE IN A CARDBOARD BOX WHICH WAS NOT DAMAGED; HOWEVER, THE DEVICE BOX INSIDE WAS DAMAGED AND SMASHED -INDICATING THAT IT WAS SHIPPED FROM THE MFR IN THAT CONDITION.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN EVALUATED WITH THE FOLLOWING RESULTS: A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THAT A CORNER OF THE DEVICE BOX HAD BEEN CRUSHED. THE DEVICE ITSELF; HOWEVER, WAS FOUND TO BE NON-DEFECTIVE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CATALOG/LOT NUMBER AND NO TRENDS WERE IDENTIFIED. THE FACILITY'S REPORT THAT THE DEVICE BOX WAS DAMAGED WAS CONFIRMED BY THE MFR'S EVALUATION OF THE RETURNED DEVICE. THE CAUSE OF THIS EVENT; HOWEVER, COULD NOT BE DETERMINED. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE IN THIS EVENT.
THE UNIT HAD A FREE FLOW. THE UNIT HAD JUST BEEN SET UP AND CALIBRATED, BUT NOT PROGRAMMED, WHEN THE USER NOTICED THAT ABOUT 100ML OF FLUID WAS IN THE FINAL BAG. WHEN ASKED BY THE REPORTER, THE USER SAID THEY DO PRESTRETCH THE TUBING PRIOR TO INSTALLING THE SET IN THE UNIT AND THEY DO TURN THE ROTORS. THE REPORTER INSTRUCTED THE ACCOUNT TO NOT PRESTRETCH THE TUBING, BUT TO TURN THE ROTORS. SINCE THE PROBLEM WAS RESOVLED BY TELEPHONE, THE UNIT WAS NOT SWAPPED OUT. NO PT INVOLVEMENT 8/13/96.
SECTION F COMPLETED BY CO, BASED ON INFO OBTAINED FROM REPORTER. SECTION H3. DEVICE NOT RETURNED. ISSUE RESOLVED BY TELEPHONE USER ERROR.
THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. THE HP050 WAS NOT PROVIDING ADEQUATE COAGULATION TO TISSUE. A FLAT LINE SOUND WAS EMITTED WITH THE TEST TIP. COAGULATION WAS ACHIEVED WITH BOVIE AND CAUTERY. SERIAL NUMBERS HEE0115-21, HEE0115-22. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: NO PROBLEM FOUND WITH THE HAND PIECE. VISUAL INSPECTIONS & RESULTS: DAMAGE TO ELECTRICAL CONNECTOR; NO. EXTERNAL PHYSICAL DAMAGE; NO. FUNCTIONAL TESTS & RESULTS: CAPACITANCE OUT OF SPECIFICATION; NO. FREQUENCY OUT OF SPECIFICATION; NO. IMPEDANCE OUT OF SPECIFICATION; NO. PIN RESISTANCE OUT OF SPECIFICATION; NO. POWER LEVEL/MOTION REQUIREMENTS; NO. ANALYSIS CONCLUSION: BASED ON THE INQUIRY INFO RECEIVED, THE VISUAL AND FUNCTIONAL TESTING, THE HANDPIECES WERE FOUND TO BE CONFORMING. THE DEVICES WERE RECEIVED IN GOOD PHYSICAL CONDITION AND TESTED AND MET SPECIFICATION REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT.
ACCOUNT REPORTED THAT WHAT WAS DISPLAYED ON THE SCREEN WAS DIFFERENT FROM WHAT HE PUNCHED IN ON THE KEYPAD, E.G. IF HE HIT "3", A "5" WOULD BE DISPLAYED. THIS OCCURRED DURING MANUAL ENTRY OF A PT ID, SO THERE WAS NO PT INVOLVENENT. THE UNIT WAS TAKEN OUT OF SVC AND THE BACK UP UNIT USED. THE UNIT WAS SWAPPED OUT. 8/13/96.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE STONE RETRIEVAL SHAFT DETACHED FROM THE INSTRUMENT AND FELL INTO THE PT'S ABDOMEN. IT WAS RETRIEVED WITHOUT DIFFICULTY, BUT DID REQUIRE SOME TIME TO REMOVE. PHOTOGRAPH OF THE BROKEN INSTRUMENT INSIDE THE PT WAS RETURNED TO CO. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D10: INFORMATION UNAVAILABLE: D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
DURING A VITRECTOMY PROCEDURE ON AN ANIMAL, THE VITRECTOMY FUNCTION OF THIS OPHTHALMIC MICROSURGICAL SYSTEM WOULD NOT PULSE. THE PROCEDURE WAS CANCELLED AND WILL BE RESCHEDULED. THIS UNIT IS USED ON ANIMALS AT A RESEARCH FACILITY.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. THE DEVICE WAS USED TO PERFORM THE ANASTOMOSIS OF THE RECTUM TO PROXIMAL BOWEL. A LOUD CRUNCH WAS NOT HEARD WHEN THE DEVICE WAS FIRED. THE DEVICE WAS DIFFICULT TO OPEN AND REMOVE. NO TISSUE WAS CUT AND NO STAPLES WERE OBSERVED IN TISSUE OR IN THE INSTRUMENT. A SECOND DEVICE WAS OPENED, INSERTED AND FIRED TO COMPLETE THE ANASTOMOSIS. THERE WAS NO CONSEQUENCE TO THE PT.
CONTACTED SURGEON AND RISK MANAGER. INFO NOT AVAILABLE. BASED ON INFO RECEIVED AND THE VISUAL INSPECTION, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. AS THE ANVIL OR THE BREAKAWAY WASHER WERE NOT RETURNED WITH THE INSTRUMENT, FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE BATCH HISTORY RECORDS WERE RETRIEVED AND REVIEWED. THERE WAS NO INCIDENCE NOTED OF MISSING STAPLES.
UNIT OVERFILLED FINAL CONTAINER FROM TWO SOURCE CONTAINERS, BASED ON STATION VOLUME DELIVERED DISPLAYS AND TOTAL VOLUME DISPLAY. RPTR DID NOT KNOW THE ACTUAL VOLUMES, ONLY THAT THE OVERFILL WAS 15-20ML PER STATION. SINCE THIS DID NOT PERMIT CALCULATION OF WHETHER THE UNIT WAS OPERATING WITHIN SPECIFICATION LIMITS, THE UNIT WAS TAKEN OUT OF OPERATION AND SWAPPED OUT. NO PT INVOLVEMENT. 8/15/96.
PHYSICIAN WAS CLOSING INCISION FROM CHOLECYSTECTOMY WHEN NEEDLE BROKE OFF IN SUBCUTANEOUS TISSUE OF PT'S ABDOMEN. PHYSICIAN MANUALLY EXPLORED TISSUES, ABDOMINAL EXPLORATION WITH CAMERA AND X-RAYS. NEEDLE NOTED ON X-RAY BUT UNABLE TO PHYSICALLY LOCATE AND RETRIEVE.
DURING A DILATATION PROCEDURE, THE CATHETER COULDN'T BE REMOVED THROUGH THE 5 FRENCH SHEATH. THE CATHETER & SHEATH WERE REMOVED TOGETHER AND REPLACED WITH THE SAME MODELS TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR.
3/8/95 RT MASTECTOMY WITH IMMEDIATE RECONSTRUCTION WITH TISSUE EXPANDER. 8/16/96 RT BREAST CAPSULECTOMY WITH PLACEMENT OF PERMANENT SALINE IMPLANT. 9/6/96 MARKED DOWN IN RT BREAST SIZE CONSISTENT WITH POSSIBLE VALVE FAILURE. 9/13/96 IMPLANT REMOVAL AND REPLACED.
DURING A BILATERAL TUBAL LIGATION THE 511S TROCAR WAS ARMED AND AN ATTEMPT WAS MADE TO INSERT IT THROUGH THE ABDOMINAL WALL. THE SURGEON WAS UNABLE TO HAVE THE DEVICE PENETRATE THE ABDOMINAL WALL DUE TO THE SAFETY WOULD NOT RETRACT AND THE BLADE WOULD NOT EXPOSE. A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT COULD NOT BE DETERMINED WHY THE INSTRUMENT'S BLADE REPORTEDLY "WOULD NOT EXPOSE" DURING SURGERY. THE INSTRUMENT WAS RECEIVED WITH THE RESET BUTTON IN THE UNARMED POSITION, BUT THE INSTRUMENT WAS NOT LOCKED-OUT. THE INSTRUMENT WOULD NOT LOCK-OUT WHEN TESTED. THE ENDCAP WAS DISASSEMBLED AND NO ANOMALIES OR DEFORMITIES WERE OBSERVED. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS. APPROPRIATE ENGINEERING AND MFG PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.
LASER CONTINUED TO LASE AFTER REMOVING FOOT FROM FOOT PEDAL. RPTR STATED THAT APPROX 4747 JOULES INTO A KNEE ARTHROSCOPY PROCEDURE (LIMITED SYNOVECTOMY), THE PHYSICIAN REMOVED HIS FOOT FROM THE FOOT PEDAL, AND THE LASER TECH ALONG WITH THE PHYSICIAN NOTED THAT THE LASER CONTINUED TO LASE. AT THE SAME TIME, THE PHYSICIAN PULLED FIBER BACK INTO SCOPE AND THE EMERGENCY SHUT-OFF BUTTON WAS IMMEDIATELY DEPRESSED. THE LASER WAS RESTARTED AND IT WORKED FINE, THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO INJURIES TO STAFF OR PT WERE REPORTED.
THE FIELD SERVICE ENGINEER CONCLUDED THAT THE FOOTSWITCH HAD MECHANICALLY STUCK IN THE "ON" POSITION. FURTHER EVALUATION OF THE FOOTSWITCH REVEALED THAT THE TENSION ON THE LEVER FELT LESS THAN NORMAL. IT WAS ALSO NOTED THAT THE LEVER HINGE PIN APPEARED TO BE PROTRUDING OUT OF THE HOUSING APPROXIMATELY 1/8 INCH, WHICH IS NOT NORMAL. DURING EVALUATION OF THE FOOTSWITCH, THE FIELD SERVICE ENGINEER IDENTIFIED OTHER UNRELATED LASER COMPONENTS THAT REQUIRED SERVICE AND THE LASER AND FOOTSWITCH WERE RETURNED TO CO. UPON RECEIPT OF THE LASER AND FOOTSWITCH, THE LASER WAS REPAIRED AND THEN TESTED WITH THE REPORTED FOOTSWITCH. THE EVENT DID NOT RECUR. A FOOTSWITCH KNOWN TO FUNCTION PROPERLY WAS ADJUSTED MANUALLY TO RECREATE THE LEVER HINGE PROTRUSION CONDITION DESCRIBED ABOVE. THE MALFUNCTION DID NOT RECUR WHEN THIS FOOTSWITCH WAS USED WITH A LASER SYSTEM KNOWN TO PERFORM WITHIN SPECIFICATIONS. TWO ADDITIONAL POSSIBILITIES FOR FOOTSWITCH FAILURE WERE CONSIDERED: 1) THE FOOTSWITCH HAD A FOREIGN OBJECT JAMMED BETWEEN THE SPRING RELIEF ON THE BOTTOM OF THE FOOT PEDAL AND PUSH ROD, AND, 2) A MICROSWITCH MALFUNCTIONED IN CIRUITRY. CO QUALITY ENGINEERING CONFERRED WITH THE MFR OF THE FOOTSWITCH AND FOUND THAT THE MEAN TIME BETWEEN FAILURE RATE ON THE MICROSWITCH USED IN THE FOOTSWITCH IS A MILLION AND A HALF CYCLES. BASED ON THAT INFORMATION, IT IS UNLIKELY THAT THE MICROSWITCH WAS THE CAUSE OF THE FAILURE. UPON FURTHER DISCUSSION WITH THE FIELD SERVICE ENGINEER, IT IS MORE LIKELY A FOREIGN OBJECT CONTRIBUTED TO THE FAILURE.
DURING A DILATATION PROCEDURE, THE CATHETER COULDN'T BE REMOVED THROUGH THE 5 FRENCH SHEATH. THE CATHETER & SHEATH WERE REMOVED TOGETHER AND REPLACED WITH THE SAME MODELS TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS BEING REPORTED.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR. BLOCK H6 FOR RESULT CODE 100-ASSIGNED DUE TO THE TESTING COULDN'T BE COMPLETED FOR THE REPORTED EVENT BECAUSE OF THE CONDITION OF THE RETURNED SAMPLE.
A FREE FLOW HAD OCCURRED. THE UNIT HAD JUST BEEN SET UP AND STERILE WATER FLOWED INTO THE FINAL BAG. UPON QUESTIONING, THE CALLER STATED THAT THEY DON'T PRESTRETCH THE TUBING, BUT THEY DON'T TURN ROTORS. REPORTER REFERRED CALLER TO OPERATORS MANUAL WHICH INSTRUCTS THE USER TO TURN ROTORS. THE CALLER STATED THAT THE FREE FLOW STOPPED AFTER THEY MANIPULATED THE TUBING. SINCE THE ISSUE WAS RESOLVED BY TELEPHONE, THE UNIT WAS NOT SWAPPED OUT. NO PT INVOLVEMENT. 8/16/96.
SECTION F COMPLETED BY CO, BASED ON INFO OBTAINED FROM REPORTER. SECTION H3: DEVICE NOT RETURNED TO MFR. ISSUE RESOLVED BY TELEPHONE. USER ERROR.
AFTER A SUCCESSFUL DILATATION PROCEDURE, THE CATHETER COULDN'T BE REMOVED THROUGH THE 5 FRENCH SHEATH. THE CATHETER AND SHEATH WERE REMOVED TOGETHER WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR. BLOCK H6 RESULT CODE 100-ASSIGNED DUE TO TESTING FOR THE REPORTED EVENT COULDN'T BE PERFORMED DUE TO THE CONDITION OF THE RETURNED SAMPLE.
RPTR HAD SILICONE IMPLANTS PUT IN BY A PLASTIC SURGEON WHO ASSURED HER THERE WOULD BE NO SIDE EFFECTS AND THE DEVICE WAS PERFECTLY SAFE. 3 YRS LATER, RPTR DEVELOPED TERRIBLE ARTHRITIS, CONNECTIVE TISSUE DISEASE, MUSCLE DISEASE, SLEEPING DISORDER AND CHRONIC FATIGUE. DEVICE WAS EXPLANTED 7 1/2 YRS LATER WITH A LITTLE RELIEF NOTED 6 MONTHS LATER. ONE WAS RUPTURED.
AFTER A SUCCESSFUL DILATATION PROCEDURE, CATHETER COULDN'T BE REMOVED THROUGH THE 5 FRENCH SHEATH. CATHETER & SHEATH WERE REMOVED TOGETHER WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
THE UNIT MIGHT BE OVERFILLING FINAL CONTAINERS BASED ON SOURCE CONTAINERS EMPTYING EARLIER THAN ANTICIPATED. THE CALLER SAID THIS WAS OCCURING ON THE STATION WITH THE ELECTROLYTE POOL WHICH THEY PUT IN AN EVACUATED BOTTLE AND ALLOW FOR 10% OVERAGE. THE UNIT IS PROGRAMMED MANUALLY. THE ACCOUNT HAS NOT SEEN ANY PT INCIDENTS. THE USER WAS ADVISED NOT TO USE THE UNIT, WHICH WAS SWAPPED OUT. 8/25/96.
EVALUATION: THE UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINTS COULD NOT BE DUPLICATED.
THE VALVE WAS REMOVED DUE TO A PERIVALVULAR LEAK. A LARGE GAP BETWEEN ONE OF THE STRUTS AND THE MITRAL VALVE ANNULUS DURING REOPERATION. LEAK WAS NOT PRESENT PER TEE AT ORIGINAL IMPLANT DATE OR ON 1ST FOLLOW-UP ECHO. VALVE IMPLANTED 5 MONTHS.
SUBMISSION OF INFO BY CO UNDER THE MDR REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." H11. F10 CODES: PT CODE 2201-LABELED, #2376-LABELED. DEVICE CODE: #1457-LABELED. A MEDWATCH FORM WAS NOT RECEIVED FROM THE USER FACILITY THEREFORE, INFO WAS FILED IN BY CO WITH INFO RECEIVED FROM THE MD. "ANY MISSING OR IMCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE RPTR. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE RPTR, CO IS UNABLE TO COMPLETE FORM 3500A. THE LEAFLETS ARE INTACT AND FLEXIBLE. SMALL AREA OF SMOOTH WHITE HOST TISSUE ON THE INFLOW EDGE OF THE DEVICE. SMALL AREA OF TAN GRANULAR MATERIAL ON OUTFLOW OF ONE CUSP. NATURAL FENESTRATION WAS NOTED AND MET SPECIFICATION AND THE PRODUCT MET ALL OTHER SPECIFICATIONS THEREFORE, A CAUSE OF THE REPORTED PERIVALVULAR LEAK COULD NOT BE DETERMINED.
DURING A DILATATION PROCEDURE, CATHETER BALLOON RUPTURED. CATHETEER WAS REMOVED AND REPLACED WITH SAME MODEL TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY ID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WER TO RECUR.
AFTER A SUCCESSFUL DILATATION PROCEDURE, THE CATHETER COULND'T BE REMOVED THROUGH THE 5 FRENCH SHEATH. THE CATHETER AND SHEATH WERE REMOVED TOGETHER WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. DATE DEVICE EXPIRES: 5/31/2001.
9/24/96-CORRECTED INFORMATION SUBMITTED FOR B-4 AND F-8. ADDITIONAL INFORMATION SUBMITTED FOR D-9. DEVICE EVALUATION INDICATED AND CODES ENTERED FOR H-3 AND H-6.
AFTER A SUCCESSFUL DILATATION PROCEDURE, CATHETER COULDN'T BE REMOVED THROUGH THE 5 FRENCH SHEATH. THE CATHETER AND SHEATH WERE REMOVED TOGETHER WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGUALTIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR.
PT BECAME AWARE OF METAL SHAVINGS AND WIRE EMBEDDED IN PAD. PT GAVE PAD BACK TO NURSING. DEVICE WAS NOT USED.
PT RECEIVING ANTIBIOTIC THERAPY IN THE HOME. PT HAD 22G CATHETER PLACED IN LEFT HAND. AFTER FINISHING LAST DOSE OF THERAPY, PT WENT TO REMOVE CATHETER AND THE WHITE CATHETER DISCONNECTED FROM THE BLUE HUB. THE TIP OF THE CATHETER WAS STICKING OUT OF THE VEIN ENOUGH THAT THE PT WAS ABLE TO GRAB IT AND PULL IT OUT.
THE PT, A TYPE II DIABETIC ON DAILY INSULIN INJECTIONS, REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH STRIPS LOT 1H512A. APPROX ONE WEEK AGO, THE PT PERFORMED A BLOOD GLUCOSE TEST WITH STRIPS LOT 1H512A AND OBTAINED A BLOOD GLUCOSE RESULT OF 60 MG/DL. TWENTY MINUTES LATER , HE WENT TO HIS PHYSICIAN'S OFFICE FOR A ROUTINE CHECK UP AND A VENOUS BLOOD GLUCOSE SAMPLE WAS DRAWN. BECAUSE HE QUESTIONED THE 60 MG/DL READING WITH STRIPS, THE PT PERFORMED A BLOOD GLUCOSE TEST WITH A NEW BOX OF STRIPS 1A609A, CODE 8, EXP 8/97. TWENTY MINTES AFTER THE VENOUS SAMPLE WAS DRAWN. HE OBTAINED A BLOOD GLUCLOSE RESULT OF 140 MG/DL. WHEN HE REC'D HIS VENOUS BLOOD GLUCOSE RESULT OF 160 MG/DL, HE CALLED CUSTOMER SUPPORT LINE. WITH THE REP THE PT OBTAINED A BLOOD GLUCOSE RESULT OF 93 MG/DL WITH LOT 1H512A AND A RESULT OF 161 MG/DL WITH LOT 1A609A. THE DESICCANT IS IN BOTH BOTTLES OF TEST STRIPS.THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. WITH THE REP, THE PT OBTAINED A NORMAL CONTROL SOLUTION RESULT OF 161 MG/DL WITH LOT 1A609A WHICH IS WITHIN THE NORMAL CONTROL SOLUTION RANGE OF 117-175 MG/DL. HE WAS UNWILLING TO PERFORM A NORMAL CONTROL SOLUTION TEST WITH LOT 1H512A BECAUSE "THEY ARE BAD". ALSO WITH THE REP, A CHECK STRIP TEST WAS PERFORMED AND THE RESULT WAS 82 VERSUS A CHECK STRIP RANGE OF 72-96. THE PT WILL RETURN LOT 1H512A TO CO FOR EVAL.
RETENTION SAMPLES FOR LOT #1H512A WERE COMPARED WITH REF METHOD (YSI) AND WERE WITHIN ALL SPECS FOR ACCURACY AND PRECISION. CONTROL VALUES WERE WITHIN RANGE. DIAGNOSTIC SOLUTIONS HAS NOT HAD SUFFICIENT TIME TO EVALUATED CUSTOMER'S RETURNED PRODUCT. INVESTIGATION IS UNDERWAY AND FOLLOW-UP INFO WILL BE PROVIDED TO FDA AT THE CONCLUSION OF THIS INVESTIGATION. TIME FRAME APPROX SIX WEEKS. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? NO. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE ? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING ? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE ? NO.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE STAPLES DID NOT HOLD. THE HOSP HAS REPORTED NO PT INJURY.
THE DEVICE WAS USED DURING A HYSTERECTOMY PROCEDURE. REPORTEDLY THE SUTURE BROKE DURING THE PROCEDURE. SURGEON USED ANOTHER TO COMPLETE THE PROCEDURE. HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
A DEVICE WAS REMOVED AFTER COMPLETION OF THERAPY. UPON WITHDRAWAL THE CATHETER SEPARATED FROM THE HUB, WITHOUT TEARING, "IT JUST SLIPPED OUT." THE CATHETER WAS EASILY REMOVED FROM THE PT WITHOUT INCIDENT OR COMPLICATION.
DATE SENT TO FDA: 10/11/96. H2--JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MFR AND SALE OF THE STREAMLINE, LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 9/18/96. DATE SENT TO FDA: 11/15/96. H6- ADD'L INFO: CO HAS EXAMINED THE DEVICE HISTORY RECORD AND BASED ON OUR EXAMINATION, CAN IDENTIFY NO CAUSE FOR THE EVENT REPORTED. FOR BUSINESS REASONS, CO HAS DECIDED TO DISCONTINUE THE DISTRIBUTION OF THIS BRAND OF I.V. CATHETER. CO WILL CONTINUE TO TRACK THIS TYPE OF INFO AS IT IS CRITICAL TO PRODUCT IMPROVEMENT AND DEVELOPMENT PROCESS. H4-MANUFACTURING DATE INSERTED.
THE VALVE WAS REMOVED DUE TO INSUFFICIENCY. AN INFECTION WAS NOTED IN 2/96. THE VALVE HAD BEEN IMPLANTED 50 MONTHS.
SUBMISSION OF INFO BY CO UNDER THE MDR REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." THIS EVENT WAS FIRST REPORTED TO CO BY THE MD ON AN EXPLANT KIT FORM. CO SENT THE MEDWATCH FORM TO THE USER FACILITY TO COMPLETE PER ITS REQUEST. NO MEDWATCH FORM WAS RETURNED THEREFORE CO COMPLETED THE FORM WITH AS MUCH INFO AS WAS PROVIDED BY THE MD. H11. F10 CODES: PT CODE #1834 IS LABELED, #1715 IS LABELED. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE RPTR. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE RPTR, CO IS UNABLE TO COMPLETE FORM 3500A". ANALYSIS: ANALYSIS SHOWS THAT THE INSUFFICIENCY WAS DUE TO HOLES IN THE LEAFLETS. THE TISSUE DETERIORATION IS POSSIBLY DUE TO LEAFLET CONTACT WITH THE BIAS CLOTH. THE RADIOGRAPH SHOWS THAT THE VALVE IS FREE OF MINERALIZATION. H.6 CONCLUSION CODE 68: DEVICE DEGRADATION WAS RELATED TO THE EVENT.
THE DEVICE WAS APPLIED DURING A HYSTERECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER INSTRUMENT. THE HOSP HAS REPORTED NO PT INJURY.
THE PT REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH STRIPS, LOT 1J521A. SHE OPENED THE BOTTLE OF TEST STRIPS ON APPROX. 7/25/96 AND IMMEDIATELY OBTAINED BLOOD GLUCOSE RESULTS IN THE 20 MG/DL RANGE. ALTHOUGH THE PT HAD NO HYPOGLYCEMIC SYMPTOMS, SHE DID NOT QUESTION THESE READINGS. ON 8/4/96, THE PT OBTAINED A BLOOD GLUCOSE RESULT OF 26 MG/DL WITH CO STRIPS. WHEN SHE WENT TO HER PHYSICIAN FOR A ROUTINE CHECK-UP ON 8/5/96, SHE OBTAINED A VENOUS BLOOD GLUCOSE RESULT OF 126 MG/DL. SHE DID NOT PERFORM A BLOOD GLUCOSE TEST WITH STRIP AT THIS TIME. WITH THE REP, THE PT OBTAINED A BLOOD GLUCOSE RESULT OF 29 MG/DL. THE DESICCANT IS IN THE BOTTLE OF TEST STRIPS. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE PT DID NOT HAVE NORMAL CONTROL SOLUTION AVAILABLE TO CHECK THE TEST STRIPS FOR ACCURACY. WITH THE REP, THE PT OBTAINED BACK TO BACK CHECK STRIP RESULTS OF 80 AND 79 VERSUS A CHECK STRIP RANGE OF 70-94.
THIS COMPLAINT IS UNDER INVESTIGATION. FURTHER INFO WILL BE PROVIDED TO FDA AT THE CONCLUSION OF THIS INVESTIGATION. TIME FRAME UNKNOWN. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N.
DESCRIBE EVENT OR PROBLEM: REPORT OF A FAILURE.
INVESTIGATION CONDUCTED. DOCTOR CITES BONE QUALITY INSUFFIENT AS CAUSE FOR FAILURE. PT IS A SMOKER, CONSUMES ALCOHOL AND HAS DIMINISHED ORAL HYGIENE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING A BOWEL RESECTION ON THE 3RD FIRING, THE DEVICE WOULD NOT FIRE. IT WAS THE LAST FIRING SO THE SURGEON USED SUTURE TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6;H3,4,6;G4: ADDED ADDITIONAL INFO. CONCLUSION: BASED ON THE INFO RECIEVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS FIRED AND FIRED AND FORMED STAPLES AS DESIGNED ACROSS THE ENTIRE STAPLE LINE. ADDITIONALLY, THE KNIFE CUT THE TEST MEDIA COMPLETELY ACROSS THE ENTIRE STAPLE LINE WITH NO DIFFICULTIES NOTED. AS THE CARTRIDGE WAS NOT RETURNED FOR ANALYSIS, THE INTERACTION BETWEEN THE INSTRUMENT AND CARTRIDGE COULD NOT BE ANALYZED. THEREFORE, THE INCIDENT THAT OCCURRED DURING SURGERY COULD NOT BE RECREATED. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
UNIT HAD UNDERFILLED A FINAL CONTAINER FROM THREE STATIONS. THIS WAS BASED ON COMPARING DISPLAYS FOR PROGRAMMED VERSUS DELIVERED VOLUME. SINCE THE REPORTED DIFFERENCES EXCEEDED THE LIMITS OF THE PRODUCT SPECIFICATIONS. THE USER WAS ADVISED NOT TO USE THE UNIT, WHICH WAS SWAPPED OUT. NO PT INVOLVEMENT. 8/12/96.
SECTION F WAS COMPLETED BY CO, BASED ON INFO OBTAINED FROM REPORTER. EVALUATION: THE UNIT WAS RECEIVED WITH THE UPPER AND LOWER HINGES DAMAGED BY FLUID SPILLAGE. THE UNIT WAS CLEANED PRIOR TO INCIDENT TESTING. NO OTHER SERVICE OR REPAIR WAS PERFORMED PRIOR TO TESTING. IN THIS CONDITION, THE UNIT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT OF UNDERDELIVERY COULD NOT BE DUPLICATED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE CARTRIDGE DISENGAGED. THE CARTRIDGE WAS RETRIEVED WITHOUT INCIDENT. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE.
SEVEN OF NINE PTS DEVELOPED PROBLEMS WITH THEIR DIALYZERS WHILE THEY WERE RECEIVING THEIR NORMAL DIALYSIS THERAPY. THE BLOOD LEAK ALARMS WENT OFF AND THEY WERE SWITCHED TO OTHER DIALYZERS. NINE TO THIRTEEN HOURS LATER SEVEN PTS DEVELOPED THE FOLLOWING SYMPTOMS: CONJUNCTIVITIS, CORNEAL OPACIFICATION, OPTIC NEURITIS WITH SCLERAL OPACIFICATION, AND BLINDNESS (THEY COULD NOT SEE LIGHT), ALSO SENSORY HEARING LOSS AND SEVERE HYPERESTHESIAS. TWO PTS HAD A CARDIAC ARREST, ONE 54 YR-OLD WOMAN REMAINS "BRAIN DEAD". THE DIALYZER BEING USED FOR THERAPY ON THE SEVEN PTS WAS A CELLULOSE ACETATE MEMBRANE DIALYZER WHICH WAS MFG ABOUT TWELVE YRS AGO ACCORDING TO THE MFR. IT IS NOT CLEAR WHY THE TECHNICIAN PICKED THESE OLD INVENTORY DIALYZERS FOR USE THAT DAY. ALL SEVEN DIALYZERS WERE DISCARDED AND THE FIVE OF THE SAME LOT ON THE SHELF IN THE STORAGE AREA WERE ALSO TOSSED OUT BY THE TECHNICIAN BEFORE ANY OF THE PTS EXHIBITED THE ABOVE SYMPTOMS.
THE VENTILATOR STOPPED CYCLING AFTER 5 BREATHS. THE MINUTE VOLUME DISPLAY PEGGED TO 40 L/M.
THE REPORTED FAILURE COULD NOT BE REPRODUCED. APPARENT LIQUID SPILLAGE WAS FOUND ON PC 763. THE BOARD WAS REPLACED AS A PREVENTIVE MEASURE. THE DEVICE FUNCTIONED WITHIN SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER.
THE BALLOON WOULD NOT DEFLATE. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS CONFIRMED SLOW DEFLATION. THE CATHETER SHAFT REVEALED A KINK IN THE INFLATION LUMEN WHICH MAY HAVE RESTRICTED THE FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE INSTRUMENT MISFIRED. THE HOSP HAS REPORTED NO PT INJURY.
THE CUSTOMER REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH TEST STRIPS. ON 8/4/96 SHE OPENED A NEW BOTTLE AND OBTAINED CONSECUTIVE READINGS OF 26,36 AND 44MG/DL. THE TESTS WERE PERFORMED IN THE MORNING (FASTING) WITHIN A TIME SPAN OF 15 MINUTES. BECAUSE SHE FELT THAT THE READINGS WERE INACCURATE, THE CUSTOMER CALLED THE CO CUSTOMER SUPPORT LINE ON 8/6/96. WITH THE REP, THE CUSTOMER PEROFORMED TWO NORMAL CONTROL SOLUTION TESTS. THE RESULTS WERE 26 AND 45 MG/DL VERSUS A CONTROL RANGE OF 107-161 MG/DL. THE SOLUTION, ANOTHER BRAND LOT #VE136, EXPIRATION 5/98, WAS OPENED TWO WEEKS AGO AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. ALSO WITH THE REP, A CHECK STRIP TEST WAS PERFORMED AND THE RESULT WAS 84 VERSUS A RANGE OF 72-98. THE DESSICANT IS IN THE OPENED BOTTLE.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 8/22/96. THE TEST RESULTS OF THE RETURNED BOTTLE OPENED BY THE CUSTOMER, CONTAINING 5 STRIPS WITH DESICCANT CONFIRMED THE LOW READINGS OF BLOOD GLUCOSE AND NORMAL CONTROL SOLUTION. THE TEST RESULTS OF THE RETURNED BOTTLE OPENED BY CO MET SPECIFICATIONS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL RANGE. FURTHER EVAL. OF THE DESICCANT INSIDE THE CUSTOMER OPENED RETURNED BOTTLE INDICATED THE FAILURE OF TEST STRIPS MAY BE DUE TO EXPOSURE TO MOISTURE. SOURCE OF THE EXPOSURE IS UNKNOWN. RETENTION SAMPLE TEST RESULTS CONTINUE TO PROVIDE ACCEPTABLE PERFORMANCE INDICATING NO TREND OF PRODUCT DEGRADATION. SINCE THE TEST RESULTS FROM THE RETURNED BOTTLE OPENED BY CO DO NOT CONFIRM THE COMPLAINT OF LOW READINGS AND THE RETENTION SAMPLES SHOW NO TREND OF DEGRADATION, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELNG? N. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? N. IS EVENT OCCURRING WITH GREATER SERVERITY THAN IS USUAL FOR DEVICE? N.
THE UNIT HAD OVERFILLED A FINAL CONTAINER WITH AN E-30 ALARM. SHE WAS ALSO CONCERNED ABOUT THE ACCURACY OF THE UNIT BECAUSE THE "ERRATIC RESPONSE OF THE LOAD CELL." THE CALLER STATED THAT STATION 2 WAS PROGRAMMED TO DELIVER 90ML BUT THE DISPLAY INDICATED THAT 125ML HAD BEEN DELIVERED, AND THAT THE UNIT WENT TO COMPLETE AND AN E-30 ALARM OCCURRED. SHE ALSO STATED THAT THE LOAD CELL DISPLAYED 41 GRAMS WITH NO WEIGHT ON IT AND 1365 WITH THE 1000 GRAM WEIGHT. THE USER WAS ADVISED NOT TO USE THE UNIT, WHICH WAS SWAPPED OUT. NO PT INVOLVEMENT. 8/12/96
SECTION F COMPLETED BY CO, BASED ON INFO OBTAINED FROM REPORTER. EVALUATION: THE UNIT WAS RECEIVED IN VERY POOR CONDITION, DIRTY FROM SOLUTION SPILLS, AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
THE VENTILATOR OPERATED ERRATICALLY, THE FRONT PANEL LIT UP (VARIOUS LED'S AND MESSAGES), THEN STOPPED CYCLING.
THE PROBLEM WAS ISOLATED TO A BAD DC/DC CONVERTER ON THE PC 1618 BOARD.
CALLER FROM ACCOUNT REPORTED TWO SEPARATE INCIDENTS WITH THE UNIT. A FREE FLOW ON ONE STATION OCCURRED ONE DAY AND AN OVERFILL FROM ONE STATION OCCURRED THE NEXT DAY. IN THE FIRST INCIDENT 10ML OF SOLUTION ENTERED THE FINAL CONTAINER BEFORE THE UNT WAS PROGRAMMED WHILE IT WAS SITTING IDLE. IN THE SECOND INCIDENT, THE VOLUME DELIVERED DISPLAY ON STATION 8 READ 11.01 WHEN IT WAS PROGRAMMED TO DELIVER 1.01ML. THE USER WAS ADVISED NOT TO USE THE UNIT, WHICH WAS SWAPPED OUT. NO PT INVOLVEMENT. 8/12/96.
EVALUATION: THE UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED WITH USER TRANSFER SET. THE UNIT INITIALLY WENT INTO P-28 DEVICE ALARM DURING STABILIZATION. REPLACED THE DAMAGED TRANSFER SET AND THE UNIT PASSED ALL ACCURACY TESTS. UNIT FAILED CHAMBER GUARD SWITCH TEST. THE COMPLAINT OF OVERDELIVERY AND FREE FLOW COULD NOT BE DUPLICATED.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE STAPLE DID NOT LOCK. THE SURGEON OVERSEWED TO COMPLETE. THE HOSP HAS REPORTED NO PT INJURY.
THE PT FELL ON THE FLOOR WHILE GETTING OFF THE TABLE AFTER A SCAN. SHE SUSTAINED A BROKEN FEMUR. THE OPERATOR DID NOT LOCK THE TABLE. HE WAS HOLDING THE TABLE WITH HIS LEG AND COULD NOT ASSIST THE PT OFF THE TABLE. NORMAL PROCEDURE IS TO LOCK THE TABLE DURING PT TRANSFER. THE OPERATOR MANUAL WARNS TO ASSIST THE PT DURING PT/TABLE OPERATIONS AND DISCUSSES USE OF THE TABLE LOCK. NO MALFUNCTION OF THE SYSTEM WAS REPORTED.
THE UNIT HAS OVERFILLED 2 OF 3 FINAL CONTAINERS, ONE 2.9% AND ONE BY 5.7%. SINCE THE LATTER IS OUTSIDE OF THE PERFORMANCE SPECIFICATIONS OF THE UNIT, IT WAS SWAPPED OUT. THERE WERE NO ALARMS. NO PT INVOLVEMENT. 8/25/96.
EVALUATION: THE UNIT WAS RECEIVED DIRTY AND HAD SOME DAMAGE TO THE LOWER DOOR. UNIT WAS TESTED AS RECEIVED. THE UNIT PASSED ALL ACCURACY TESTS, HOWEVER FAILED CONTINUITY TEST (DUE TO SOLUTION SPILL). THE COMPLAINT COULD NOT BE DUPLICATED.
THE UNIT OVERFILLED A FINAL CONTAINER WITH AN EXTRA 700 ML FROM STATION 6 BASED ON VISUAL INSPECTIONS OF FLUID LEVEL IN SOURCE CONTAINER ON STATION 6 AND BY REFRACTIVE INDEX OF FINAL SOLUTION. THE VOLUME DISPLAYS INDICATED THAT PROGRAMMED AND DELIVERED VOLUMES WERE IDENTICAL. THERE WERE NO ALARMS OR CALIBRATION PROBLEMS. THE CALLER STATED THAT HE HAS PRESTRETCHED THE TUBING FOR YEARS AND WILL CONTINUE TO DO SO EVEN THOUGH THE REPORTER INSTRUCTED HIM NOT TO DO SO. THE CALLER STATED THE TUBING WAS SEATED. THE BAG INVOLVED WAS THE FIRST BAG OF THE DAY. THE USER WAS ADVISED NOT TO USE THE UNIT, WHICH WAS SWAPPED OUT. NO PT INVOLVEMENT. 8/12/96.
SECTION F COMPLETED BY CO, BASED ON INFO OBTAINED FROM REPORTER. EVALUATION: THE UNIT WAS RECEIVED DIRTY FROM SOLUTION SPILLS, AND WAS TESTED AS RECEIVED. IT PASSED ALL ACCURACY TESTS AND THE COMPLAINT OF OVERDELIVERY COULD NOT BE DUPLICATED. THE UNIT DID FAIL VISUAL INSPECTION AND EMI SHIELD CONTINUITY TEST DUE TO SOLUTION SPILLAGE ON THE UNIT AT THE ACCOUNT.
THE PACEMAKER DID NOT EXCEED 75% OF ITS PROJECTED NOMINAL LONGEVITY PRIOR TO ERI AND EXPLANT.
UPON RECEIPT OF THIS PACEMAKER AT CO, CO SUBJECTED THIS UNIT TO A COMPLETED FINAL ACCEPTANCE TEST AND CO REALIZED THAT AT SOME PROGRAMMED OUTPUT AMPLITUDES THE PACER WAS INDEED RUNNING IN ITS EOL MODE, WHEREAS IN THE STANDARD PROGRAM THE BOL BEHAVIOR IS CONFIRMED. CO NOTED THAT THE PACEMAKER PROGRAM AS RECEIVED SHOWED A VENTRICULAR PULSE WIDTH OF 1.00 MSEC. IN THIS MODE THE PACEMAKER IS USING MORE CURRENT, ABOUT 50 MICRO AMPS. THEREFORE, CO IS CALCULATING THAT THE PACER USED A CAPACITY OF 1.73 AH. THIS VALUE IS FITTING TO THE INTERNAL RESISTANCE OF THE BATTERY, WHICH WAS MEASURED TO BE 7 KOHMS, WHICH REFERS TO A USED CAPACITY OF 1.7 AH.
THERMOMETER NOT READING ACCURATELY. NO INCIDENTS NOR INJURIES REPORTED.
MODEL 304 WAS REPAIRED BY REPLACEMENT OF THERMOMETER. THERMOMETER HAS NOT BEEN RETURNED BY CUSTOMER FOR EVAL.
CUSTOMER CLAIMS TO HAVE HAD INCIDENTS OF CLOT FOLDING. NO INJURIES REPORTED.
H-6 (86 OTHER) UNIT INSPECTED BY INDEPENDENT SERVICE AGENT - METHOD UNK.
THE DEVICE WAS APPLIED DURING A TOTAL GASTRECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY AND THE TISSUE WAS NOT CUT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER INSTRUMENT. THE HOSP HAS REPORTED NO PT INJURY.
A PT WAS PUT ON THE CONSOLE AND IT WAS OPERATING IN "EMERGENCY SYSTEM OPERATION." THE PT WAS PUT ON A BACK-UP CONSOLE WITHOUT INCIDENT. FIELD SVC EVALUATED THE CONSOLE AND FOUND NO PROBLEMS. IT APPEARS TO HAVE BEEN USER ERROR.
THE DEVICE WAS APPLIED DURING A TOTAL PNEUMONECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON USED MANUAL SUTURE TO COMPLETE THE CLOSURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THIS MDR IS BEING FILED IN ORDER TO COMPLY WITH 21 CFR PART 803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT THE DEVICE ACTUALLY MALFUNCTIONED OR CAUSED ANY INJURY. THE ABOVE CODES ADEQUATELY DESCRIBE THE METHODS, RESULTS, AND CONCLUSION.
DURING ROUTINE TESTS AT INSTALLATION OF UNIT, CO SVC REP NOTED OUTPUT OF VAPORIZER WAS NOT WITHIN SPEC. THERE WAS NO REPORTED PT INJURY. CO'S  INVESTIGATION INTO THE REPORTED EVNET IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE ON THE CARTOID ARTERY INVOLVING ONE PT. REPORTEDLY, THE SUTURE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SUTURE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
TWENTY-FOUR HRS AFTER IMPLANTATION BLOOD WAS NOTICED IN THE TUBING. PT WAS UNDER 1:2 ASSISTANCE. PT REPORTED TO BE STABLE. THERAPY WAS DISCONTINUED.
SECTION F PROVIDED BY MFR. SECTION A INFO REQUESTED AND NOT RECEIVED.
DURING A FEMORAL DILATATION PROCEDURE, CATHETER BALLOON RUPTURED ON THE FIRST INFLATION AT 4 BARS. THE CATHETER WAS REMOVED WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
BLOCK F10, PATIENT CODE 2202, CHANGED TO 2199 RESULTING FROM ADDITIONAL INFO.
DEVICE LABEL CODE FOR F10. POSITION 1: 1701 AND POSITION 2: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED OR RELEASED TO DATASCOPE FOR EVALUATION.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 8/9/96, 8/19/96, 9/3/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 8/19/96.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED OR RELEASED TO DATASCOPE FOR EVALUATION.
THE IAB WAS INSERTED INTO THE PT ON 7/16/96. AFTER THE PT HAD SURGERY, THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER AND THE IAB WAS REMOVED ON  7/16/96, AFTER IABP FOR 10 HRS.
UNDERDELIVERY REORTED. "THE PUMP WAS SUPPOSED TO HAVE INFUSED 2000 ML OF A TPN SOLUTION, THE PUMP DISPLAY REGISTERED 2000 ML DELIVERED, BUT ONLY APPROX 100 ML WAS GONE FROM THE BAG." THERE WERE NO ADVERSE EFFECTS TO THE PT. MULTIPLE ATTEMPTS TO OBTAIN MORE PT AND/OR DEVICE SET-UP INFO FROM THE ACCOUNT WERE UNSUCCESSFUL.
MECHANICAL DYNAMIC TESTING WAS NOTED TO BE OUT OF SPECIFICATION, HOWEVER, THE PUMP DELIVERED WITHIN SPEC DURING MANUFACTURER TEST RUN. THE DEVICE WAS ALSO RUN AT THE SAME TIME SETTINGS AS THE CUSTOMER PROTOCOL AND DELIVERED WITHIN SPEC.
BACK SUPPORT FAILED TO REMAIN IN HORIZONTAL POSITION. THE LEFT HOOK FAILED TO LOCK IN PLACE. SOMEHOW IT DISENGAGED, AND THE LEFT SEAT FELL DOWNWARDS. THE RESIDENT SOMERSAULTED AND FELL FACE FIRST TO THE FLOOR. SHE WAS BELTED WHICH REMAINED IN PLACE. THE EVENT LOCATION IS IN THE TUB ROOM.
BILATERAL BREAST EXCHANGE; CAPSULECTOMY-RT BREAST. LEFT IMPLANT INTACT.
CATHETER INSERTED 6" INTO LEFT CEPHALIC VEIN FROM PUNCTURE SITE. CATHETER WAS INSERTED EASILY, NO SENSATION OF RUBBING AGAINST VEIN WAS NOTED. EXCELLENT BLOOD RETURN DURING AND AFTER INSERTION. PT COMPLAINED OF NAUSEA, FACE WAS FLUSHED. CATHETER WAS REMOVED INTACT.
AN INVASIVE PROCEDURE WAS PERFORMED TO REMOVE TWO RATE SENSING LEADS, A LEAD (MODEL 4328 SERIAL 000510) AND A BIPOLAR LEAD (MODEL 4266 SERIAL 007701) BECAUSE OF INAPPROPRIATE SHOCKS AND AN ABNORMAL BEEP-O-GRAM. THE PHYSICIAN ELECTED TO REPLACE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ALL THE LEADS. DISTRIBUTOR UNABLE TO CONFIRM THE MODEL SERIAL NUMBER OF THE RATE SENSING LEAD AT THIS TIME, BOTH LEADS ARE LISTED ON THIS REPORT. CO'S LEAD IMPLANTED 10/28/91. REMOVED FROM SERVICE 7/23/96. IMPLANT MONTHS-57. BIPOLAR LEAD IMPLANTED 12/16/94. REMOVED FROM SERVICE 7/23/96. IMPLANT MONTHS -19.2.
THE LEAD REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM AVAILABLE INFO ON THE ALLEGED INAPPROPRIATE SHOCKS, NO FURTHER INFO IS AVAILABLE.
A #35 UMBILICAL CATHETER WAS FOUND TO HAVE A LEAK AT THE HUB AFTER INSERTION-3 OTHER CATHETERS LEAKED. UNABLE TO COMPLETE PROCEDURE PRIOR TO TRANSFER. 2 SIMILAR INCIDENTS OCCURRED ON 2/94 AND 3/94.
ONCE THE VALVE WAS SEATED, THERE WAS DIFFICULTY WITH LEAFLET MOTION. THE VALVE WAS EXPLANTED.
THE VALVE WAS RECEIVED IN CO'S ANALYSIS LAB. PRODUCT RETURNED KIT, SUBMERGED IN A LIQUID SOLUTION. THE VALVE'S IDENTIFICATION TAG WAS TAPED STO THE OUTSIDE OF THE CANISTER IN WHICH THE VALVE WAS RETURNED. THE VALVE HOLDER WAS ALSO RETURNED, BUT WAS DETACHED FROM THE VALVE. THE SEWING CUFF WAS BRWON IN COLOR AND CONTAINED NOT SUTRUES. THE VALVE WAS THEN CHEMICALLY STERILIZED, CLEANED, AND THE SEWING CUFF WAS REMOVED. THE VALVE WAS THEN VISUALLY EXAMINED AT 120X MAGNIFICATION FRO ANY ANOMALIES ON THE SURFACES OF THE LEAFLETS AND ORIFCIDE. THE LEAFLESTS AND THE ORIFICE WERE FOUNDF TO BE UNREMARKABLE. THE VALVE WASD THEN CHEMICALLY STERILIZED, CLENED, AND THE SEWING CUFF WAS REMOVED. THE VALVE WAS FDTHEN VISULLY EXAMINED AT 10X MAGINIFICATION FOR ANY ANOMALIES ON THE SURFACES OF THE LEAFLETS AND ORIFICE. THE LEAFLETS AND THE ORIFICE SWERE FOUND TO BE UNREMARKABLE. THE VALVE WAS DISASSEMBLED FOR PERFORMCANCE TESTING. THE RESULTS OF THE PULSE DUPLICATOR TESTING INDICATED THE VALVE HAD NOT OBNORMAL OPERAITON. FLOW AND PRESSURE TRACES INDICATED VALVE OPERATED SATISFACTORILY WITHOUT LEAFLET OR HYDRODYNAMIC MALFUNCTIONS. FUNCTIONAL LEAKAGE TESTING WAS PERFORMED, AND THE VALVE MET ALL CO'S SPECIFICATIONS. THE LEAFLET AND ORIFICE DIMENSIONS WERE INSPECTED AND VERIFIED TO BE WITHIN CO'S MEDICAL'S SPECIFICATIONS. THE VALVE'S DIVED HISTORY RECORD WAS EXAMINED TO ENSURE TRHAT EACH MANUFACTURING AND INSPECTION OPERATRION WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE, INDICATING THAT THE PROCESS WAS PERFORMED IN ACCORDANCE WITH CO'S SPECIFICATIONS. EACH OPERARTION FOR HTE MANUFACTURING AND INSPECTION OF THIS VALVE  WAS FOLLOWED BY THE APPROPRIATE SIGNATURE. INFORMATION REVIEWED FROM THE VALVE'S DEVICE HOSROTY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE ANALYSIS LAB INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH CO'S SPECIFICATIONS AT STHE TIME OF MANUFACTURE. THE CAUSE OF THE LEAFLET IMPINGEMENT WAS MOST LIKELY INTERFERENCE WITH THE MITRAL VALVE, AS SUGGESTED BY DR. THE DIFFICULTY IN LEAFLET FUNCTION WAS NOT DUW TO A VALVE DYSFUNCTION, AS SUPPORTED BY TESTING PERFORMED AT THE CO.
SYRINGE WAS CONNECTED TO THE INFLATION PORT OF THE FOLEY TO WITHDRAW STERILE WATER. THE WATER COULD NOT BE REMOVED AND THE BALLOON FAILED TO DEFLATE. THEREFORE THE FOLEY COULD NOT BE REMOVED FROM THE PT. THE INFLATION PORT WAS CUT IN HALF BUT THE WATER WOULD NOT DRAIN FROM THE BALLOON. THE FOLEY WAS REMOVED BY THE PHYSICIAN THROUGH INVASIVE PROCEDURE UNDER ULTRASOUND. THE PT SUSTAINED NO PERMANENT INJURY.
PT HAD DOUBLE VALVE REPLACEMENT IN 1995 FOR ENDOCARDITIS. PT DEVELOPED SHORTNESS OF BREATH, PANSYSTOLIC MURMUR, AND EARLY DIASTOLIC MURMUR CONSISTENT WITH MODERATE AORTIC INCOMPETENCE. REOPERATION WAS PERFORMED AND AORTIC VALVE WAS EXPLANTED.
ON 14 MOV., 1995, DR. IMPLANTED A 21MM AORTIC ST. JUDE MEDICAL MECHANICAL HEART VALVE HEMODYNAMIC PLUS SERIES (MODEL 21HP-105). DURING A DOUBLE VALVE IMPLANT PROCEDURE FOR ENDOCARDITIS. THE PATIENT HAD A HISTORY OF RHEUMATIC FEVER. NINE AND ONE HALF MONTHS POSTOPERATIVELY, THE PATIENT DEVELOPED SHORTNESS OF BREATH, PANSYSTOLIC MURMUR, AND EARLY DIASTOLIC MURMUR CONSISTENT WITH MODERATE AORTIC IMCOMPETENCE. RE-OPERATION WAS PERFORMED ON 1 AUG., 1996, AND THE AORTIC VALVE, AS WELL AS THE MITRAL VALVE, WERE EXPLANTED. DR. FOUND THE AORTIC VALVE TO EXHIBIT "PRACTICALLY NORMAL FUNCTION". THERE WAS A SMALL VALVE'S FUNCTION WAS MADE BY DR.. THE MITRAL VALVE REQUIRED REPLACEMENT DUE TO THE SEVERE THROMBOSIS. THE PATIENT'S INR PRIOR TO EXPLANT WAS 2.0; HOWEVER, NONCOMPLIANCE WITH THE ANTICOAGULATION REGIME WAS SUSPECTED AS THE PATIENT DID NOT SPEAK ENGLISH. BOTH VALVE WERE REPLACED WITH ST. JUDE MEDICAL MECHANICAL HEART VALVES. INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE FER ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH ST. JUDE MEDICAL SPECIFICATIONS AT THE TIME OF MFR. THIS VALVE APPEARED TO BE A NORMALLY FUNCTIONING PROSTHESIS. TESTING PERFORMED AT ST. JUDE MEDICAL DIV. INDICATED NO INTRINSIC DEFECTS ASSOCIATED WITH THIS VALVE. # PAGES = 2.
INTRAOPERATIVELY A LEAFLET FRACTURED AND THE MISSING PORTION WAS LOCATED IN THE LEFT VENTRICLE AND RETRIEVED. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER MECHANICAL HEART VALVE OF THE SAME SIZE AND TYPE.
ON 28 AUGUST, 1996, DR. IMPLANTED A 21MM AORTIC ST. JUDE MEDICAL MECHANICAL HEART VALVE (MODEL 21A-101). THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH SEVERE CORONARY ARTERY DISEASE, AORTIC VALVULAR DISEASE WITH STENOSIS AS WELL AS INSUFFICIENCY, AND MITRAL VALVE INSUFFICIENCY. THE PATIENT ALSO HAD HISTORY OF HODGKIN'S DISEASE AND CERVICAL CARCINOMA. INTRAOPERATIVELY, A SUCTION TUBE WAS BRIEFLY PLACED THROUGH THE ORIFICE OF THE VALVE. WHILE THE LAST SUTURE WAS BEING TIED, A "SUBSTANTIAL PORTION OF THE POSTERIOR LEAFLET...WAS MISSING". THE LEAFLET PORTION WAS LOCATED IN THE LEFT VENTRICLE. A VENTRICULOTOMY WAS PERFORMED, AND THE LEAFLET WAS RETRIEVED. THIS VALVE WAS EXPLANTED AND REPLACED WITH A ST. JUDE MEDICAL MECHANICAL HEART VALVE OF THE SAME SIZE AND TYPE. THE PATIENT RECOVERED FROM THIS PROCEDURE IN STABLE CONDITION, AND EXPRIENCED AN UNCOMPLICATED POSTOPERATIVE COURSE. THE VALVE'S DEVICE HISTORY RECORD WAS EXAMINED TO ENSURE THAT EACH MFG AND INSPECTION OPERATION WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE, INDICATING THAT THE PROCESS WAS PERFORMED IN ACCORDANCE WITH ST. JUDE MEDICAL'S SPECIFICATIONS. EACH OPERATION FOR THE MFG AND INSPECTION OF THIS VALVE WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE. INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH ST. JUDE MEDICAL SPECIFICATIONS AT THE TIME OF MFR. RESULTS OF THIS INVESTIGATION REMAIN INCONCLUSIVE DUE TO THE FACT ST. JUDE MEDICAL DIV. HAS NOT RECEIVED THE VALVE FOR TESTING. HOWEVER, THE INTRAOPERATIVE FRACTURE WAS MOST LIKELY DUE TO THE SUCTION TUBE BEING PLACED THROUGH THE ORIFICE, AS MENTIONED IN THE OPERATIVE REPORT, AND NOT DUE TO AN INTRINSIC DEFECT IN THE VALVE. SHOULD THE VALVE BE RETURNED TO ST. JUDE MEDICAL DIV. FOR FURTHER EVALUATION, THIS FILE SHALL BE RE-OPENED.
PT DIED DURING TREATMENT AT HOSP FOR INJURIES SUSTAINED FORM JUMPING OFF A HIGH RISE BUILDING. ATTENDING PHYSICIAN REPORTED HE WAS NOT SURE IF PT DIED BEFORE OR AFTER INTUBATION IN AN ATTEMPT TO RESUSCITATE HIM. THE PT WAS INTUBATED AND SUBSEQUENTLY AN ATTEMPT WAS MADE TO RESUSCITATE HIM THREE BREADTHS WERE GIVEN WITH THE MANUAL RESUSCITATOR. THERE WAS NO RESPONSE, THE RESUSCITATOR WAS REMOVED. THE PHYSICIAN DETERMINED THE PT HAD A PNEUMOTHORAX THEN PRONOUNCED HIM DEAD. IT WAS REPORTED THAT THE RESUSCITATOR WAS LATER EXAMINED AND IT APPEARED THAT THE PEEP VALVE MAY HAVE STUCK. NOTE: THIS CATALOG NUMBER (R1093 ALONG THE TWO ADD'L CATALOG NUMBERS) WAS MADE SPECIFICALLY AT THE REQUEST OF AND FOR THE HOSP. NO OTHER CO RESUSCITATORS HAVE A BONDED PEEP VALVE.
DUE TO ATTENDING PHYSICIAN'S UNCERTAINTY REGARDING WHEN THE PT DIED AND THE PRELIMINARY STAGE OF INVESTIGATION, CO CANNOT DETERMINE WHETHER OR NOT THE CO MANUAL RESUSCITATOR CAUSED OR CONTRIBUTED TO THE PT'S DEATH. HOSP WOULD NOT RELEASE THE SUSPECT DEVICE FOR FULL EVALUATION. ANOTHER MANUAL RESUSCITATOR (SAME CATALOG NUMBER) WITH A SIMILAR PROBLEM WAS PROVIDED FOR EVALUAITON. LOT NUMBER UNK. PRELIMINARY SUMMARY OF EVALUATION OF RELATED DEVICE. A WHITE SUBSTANCE WITH A CRYSTALLINE APPEARANCE WAS OBSERVED INSIDE THE PEEP VALVE HOUSING. BASED ON THE PRELIMINARY REVIEW OF THE ONE DEVICE MADE AVAILABLE TO CO. THIS APPEARS TO BE TETRAHYDROFURAN, THE SOLVENT USED TO BOND THE PEEP VALVE INTO THE EXHALATION PORT. THE WHITE SUBSTANCE WAS IN THE AREA OF THE VALVE DISK. THE DISK IS SPRING LOADED TO PROVIDE ADJUSTABLE PEEP. THE ADJUSTABLE CAP ON THE ONE DEVICE EVALUATED TO DATE COULD NOT BE MOVED WHEN TOUCHED LIGHTLY. THE PRODUCT IN QUESTION (PRODUCT CODES R1093, R1094, AND R1095) HAS BEEN REMOVED FROM HOSP ALONG WITH THE TWO ADD'L PRODUCT CODES WITH BONDED PEEP VALVE AND REPLACED WITH STANDARD CO'S PRODUCTS THAT DO NOT HAVE A PPEP VALVE BONDED ONTO THE EXHALATION PORT.
LABORATORY TECH REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
METHOD (86): PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM LABORATORY.
METHOD (86): PART NO RETURNED. LOT NUMBER NOT AVAILABLE FROM DISTRIBUTOR.
THE USER ENTERED THE PRODUCT BAR CODE FOR A NEW ANTIBIOTIC SUSCEPTIBILITY TEST PANEL (GNS-102) PRIOR TO LOADING THE NEW VERSION OF SOFTWARE (VTK-R04.01) REQUIRED TO OBTAIN RESULTS FROM THAT NEW TEST PANEL. THE GNS-102 LABELING INCLUDED THE REQUIREMENT FOR LOADING THE VTK-R04.01 SOFTWARE FOR THIS TEST PANEL. THE NEW GNS-102 TEST PANEL CONTAINS A THREE WELL CONFIGURATION FOR OFLOXACIN SUSCEPTIBILITY. EARLIER VERSIONS OF SOFTWARE WERE ENCODED FOR THE PRIOR TWO WELL OFLOXACIN CONFIGURATION ONLY. WHEN THE GNS-102 PRODUCT BAR CODE IS ENTERED INTO THE COMPUTER PRIOR TO LOADING THE NEW VTK-R04.01 SOFTWARE, THE NEW OFLOXACIN CONFIGURATION IS NOT CORRECTLY RECOGNIZED AND RESULTS ARE NOT CORRECTLY REPORTED FOR OFLOXACIN AND SUBSEQUENT DRUGS ON THE TEST PANEL. NO RESULTS FOR THE NEW TEST PANEL CONFIGURATIONS ARE POSSIBLE UNTIL THE NEW SOFTWARE IS LOADED. IF THE TEST PANEL PRODUCT CODE IS CORRECTLY ENTERED AFTER LOADING THE VTK-R04.01 SOFTWARE, THE RESULTS ARE CORRECTLY REPORTED. THE ERROR CONDITION OCCURS ONLY IF THE NEW TEST PANEL BAR CODE IS ENTERED PRIOR TO LOADING THE NEW SOFTWARE, AND THE TEST PANEL IS USED FOR DETERMINATIONS WITHOUT RE-ENTERING THE TEST PANEL PRODUCT BAR CODE.
SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A REPORTABLE EVENT TOOK PLACE OR THAT CO OR ANY OF ITS PRODUCTS CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT NOR DOES IT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. AN INVESTIGATION WAS CONDUCTED BASED ON CUSTOMER INQUIRIES OF OUT OF RANGE QC RESULTS. ON 8/12/96, SOFTWARE QA DETERMINED A CUSTOMER WOULD OBTAIN INCORRECT RESULTS IF THE BAR CODE WAS SCANNED AND THEN THE NEW (10.1/4.01) SOFTWARE LOADED. THE INSTRUMENT DID NOT RECOGNIZE THE NEW THREE WELL OFLOXACIN. THE CARDS CONTAINING THREE WELL OFLOXACIN WERE ANALYZED AS TWO WELL OFLOXACIN, AND ALL OF THE DRUGS ON THE CARD ANALYZED AFTER OFLOXACIN WERE USING THE INCORRECT WELLS FOR ANALYSIS. SEVERAL ACTION PLANS WERE IMPLEMENTED: 1) A LISTING WAS GENERATED  FROM MIS OF ALL CUSTOMERS WHO HAD RECEIVED CARDS CONTAINING NEW DRUGS ON 10.1/4.01 SOFTWARE, ALL CUSTOMERS WERE CONTACTED BY PHONE, AND APPROPRIATE COUNTRY MANGERS WERE NOTIFIED. 2) STOP ORDERS WERE PLACED ON ALL CARDS CONTAINING NEW ANTIBIOTICS UNTIL ADD'L LABELING WAS ADDED TO ALL AFFECTED PRODUCTS. 3) A CORRECTIVE ACTION WAS DETERMINED AND WILL BE IMPLEMENTED IN THE NEXT SOFTWARE RELEASE, VTK 5.01 AND AMS 11.0. THIS WILL NOT ALLOW THE FLEX ENTRY PROGRAM TO RECOGNIZE CARDS WITH NEW ANTIBIOTICS ON THEM UNLESS AT PROPER SOFTWARE LEVEL. THERE ARE SEVERAL PCNS THAT HAVE BEEN WRITTEN OR ARE IN THE PROCESS OF BEING WORKED ON TO COMPLETE NECESSARY CORRECTIVE ACTIONS.
NURSE WAS LOWERING HOIST WHEN IT DROPPED 6 INCHES. RIGHT HAND AND ARM REST HAS SHEARED OFF, NO INJURY TO PT OR STAFF.
DURING A VISIT FROM THE INVESTIGATOR, IT WAS FOUND THAT THE RIGHT HAND ARMREST HAD SHEARED FROM CRACK AROUND POSITION/LOCATING PIN. UPON EXAMINATION OF THE ENVIRONMENT AND INSTALLATION IT WAS FOUND THAT THE ARMREST HAD BEEN OVERSTRESSED CAUSING THE FRACTURE. THE OVERTRESSING WAS CAUSED BY PT ABUSE. INVESTIGATOR DISCUSSED THE PROBLEM WITH NURSE MGR AND A NEW RIGHT HAD ARM REST WAS FITTED. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. ADD'L INFO WILL NOT BE PRVIDED AFTER 15-DAY REPORT.
1/15/95-PT COLLAPSED IN DEPARTMENT STORE AND BROUGHT INTO EMERGENCY ROOM FACILITY. DR NOTED AN ABSENCE OF THE METAL CLICK SOUND FROM THE MITRAL VALVE REPLACEMENT AND AFTER TEST REVEALED NON-MOVING PROSTHETIC VALVE WHICH RESULTED IN PULMONARY EDEMA. PT TAKEN TO SURGERY FOR AN EMERGENCY RE-DO MITRAL VALVE REPLACEMENT. DR NOTED THERE WAS NO DISC INSIDE THE CAGE OF THE VALVE. 1/20/95-TEST REVEALED A FOREIGN BODY IN LOWER ABDOMEN. ON 1/24/95 SURGERY TO RETRIEVE THE PROSTHETIC DISC WAS PLANNED FOR 1/27/95. 1/24/95- PT COMPLAINED OF NAUSEA AFTER CT. NURSE'S NOTED CHANGE IN VENTRICULAR RATE FROM ATRIAL FIBRILLATION TO A SLOW VENTRICULAR RHYTHM. CODE BLUE CALLED BUT DESPITE AGGRESSIVE RESUSCITATION ATTEMPTS INCLUDING EXTERNAL PACING, THE PT DID NOT RESPOND AND WAS PRONOUNCED DEAD. DR NOTED BLOOD GASES REVEALED MARKEDLY ELEVATED CO2 LEVELS WITH VERY LOW PO2 LEVELS. PULMONARY EMBOLISM LIKELY CAUSE OF DEATH BECAUSE OF THE SUDDEN ONSET AND INABILITY TO ACHIEVE ADEQUATE OXYGENATION. THE VALVE WAS FIRST IMPLANTED IN 1966 WITH SEVERAL THOUSAND IMPLANTATIONS PERFORMED. PRODUCTION OF VALVE STOPPED IN 1970 DUE TO INADEQUATE PERFORMANCE. IT CAUSED SEVERE HEMOLYTIC ANEMIA. VALVE WAS A TEFLON DISC WITH TEFLON COVERED CAGE LEGS. CO WAS PURCHASED BY ANOTHER CO. IN MID SEVENTIES, THAT CO SOLD VALVE BUSINESS TO A THIRD CO WHO SUBSEQUENTLY SOLD TO ANOTHER CO WHICH WENT BANKRUPT. IN 1992, THE LONGEST KNOWN SURVIVOR OF VALVES IMPLANTS WAS 20 YRS.
THE DEVICE WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE DURING USE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. DATE DEVICE EXPIRES: 2/28/2001.
AN ABUTMENT BROKE PART HAS BEEN BROKEN FOR SOME TIME. PT DOESN'T REMEMBER IT BREAKING. PT IS REPORTEDLY FINE.
THE DEVICE WAS USED DURING A LAVH PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE DURING USE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED. DATE DEVICE EXPIRES: 2/28/2001.
THE PT RECEIVED A 50-70U BLOUS OF FORMULA OVER A 2 1/2 HR PERIOD VIA A FEEDING PUMP. THE PUMP WAS SET TO DELIVER 5CC/HR, AND INITIALLY APPEARED TO BE DELIVERING THE APPROPRIATE DOSE. WHEN THE FEEDING BAG WAS FOUND TO BE EMPTY, THE PUMP WAS SHUT DOWN. WHEN TESTED OFF OF THE PT EVEN THE PUMP TURNED OFF, FORMULA DRIPPED QUICKLY FROM THE TUBING. THE INFANT'S ABDOMINAL GIRTH INCREASED BY 2 1/2 CM AND SHE HAD APPROX. 25 CC OF ASPIRATE. SHE REQUIRED A TRANSFER TO THE PICU.
A PT PRESENTED WITH BROKEN ABUTMENT. PATIENT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM YOUR OFFICE.
DEVICE WAS USED IN RESPONSE TO A CODE BLUE ON THE SKILLED NURSING FACILITY ON 11/5/93. THE DEVICE DID NOT PROJECT AN IMAGE ONTO THE SCREEN AND ANOTHER DEVICE WAS SUBSTITUTED. THE PT DIED SUBSEQUENTLY. AFTER INVESTIGATING, IT IS FACILITY'S OPINION THAT THE INCIDENT DID NOT CONTRIBUTE TO THE DEATH OF THE PT.
THE VENTILATOR SHUT DOWN WITHOUT ACTIVATING THE FAB BOX ALARM. THE USER WAS ALERTED BY THE HUMIDIFIER'S TEMP ALARM. THE UNIT WAS TESTED BY THE BIOMEDICAL DEPT. IT WAS ESTABLISHED THAT THE FUSES F1 AND F2 ON THE POWER SUPPLY BOARD WERE DEFECTIVE. AFTER INSTALLATION OF NEW FUSES, THE VENTILATOR WAS FOUND TO FUNCTION ACCORDING TO ITS SPECS. NO PT INJURY OCCURRED. NO PROBLEMS WITH THE MAINS OR THE EMERGENCY GENERATOR HAS BEEN ESTABLISHED BY THE CUSTOMER. ON 6/14/96, THE CUSTOMER REPLACED THE POWER SUPPLY BOARD DUE TO ANOTHER MALFUNCTION. INTERNAL # V96115.
THE PC BOARD WILL BE RETURNED TO THE MFR FOR EVALUATION.
A PT WITH A HISTORY OF ABDOMINAL AORTIC ANEURYSM UNDERWENT REPAIR OF AORTIC RUPTURE. THE SUTURE WAS USED IN CONTINUOUS FASHION FOR FASCIAL CLOSURE. APPROX ONE WEEK POSTOPERATIVELY, THE PT EXPERIENCED ABDOMINAL WOUND DEHISCENCE WITH INFECTION, AND A REOPERATION WAS NECESSITATED. DURING RE-EXPLORATION, SUTURE WAS NOTED TO BE BROKEN. FOLLOWING THE RE-OPERATION, THE PT HAS BEEN DOING WELL. THE DOCTOR SUSPECTS THE INFECTION WAS A RESULT OF WOUND DEHISCENCE.
REFERENCE MFR COMPLAINT #Z96-317. CUSTOMER RETURNED SUTURES WERE EVALUATED. THE MANUFACTURING PLANT REVIEWED THE DEVICE HISTORY RECORDS. RECORDS FOUND THE LOT MET ALL INTERNAL OPERATING STANDARDS AND PROCEDURES AND ALL APPLICABLE USP SPECS. KNOT PULL STRENGTH TESTING WAS PERFORMED ON THE RETURNED SAMPLES. ALL RESULTS MET OR EXCEEDED ORIGINAL KPS TEST RESULTS AND WERE WELL ABOVE THE USP AVERAGE OF 6 LBS MINIMUM. NO OTHER REPORTS HAVE BEEN RECEIVED AGAINST THIS LOT SINCE ITS RELEASE (4/96). CO IS UNABLE TO DETERMINE A PROBABLE CAUSE OF THE REPORTED EVENT.
THE VENTILATOR WAS CONNECTED TO A PT. THE CUSTOMER REPORTS THAT THE INSPIRATORY PRESSURE ROSE AND WAS HELD AT 60CM H20. THE EXPIRED MIN VOL ALARM ACTIVATED. THE PT'S BLOOD PRESSURE FELL UNTIL THE DR REMOVED THE INSPIRATORY PT TUBE FROM THE VENTILATOR. THE PT'S BLOOD PRESSURE STABILIZED. THE VENTILATOR WAS THEN SWITCHED BACK TO THE ORIGINAL MODE OF VENTILATION AND THE VENTILATOR OPERATED NORMALLY. THE CUSTOMER THEN PROCEDED TO USE THE VENTILATOR FOR THE NEXT CASE WITH NO PROBLEMS. THERE WAS NO PT INJURY. INTERNAL # V96117.
THE PROBLEM COULD NOT BE VERIFIED, AND  OPERATING ACCORDING TO SPECIFICATION.
INPATIENT NURSE DEVELOPED REDNESS, TINGLING, AND SWELLING OF THE LIPS, AS WELL AS EYE SWELLING AND ITCHING AFTER WEARING A MASK (SUB-MICRON MOLDED SURGICAL MASK). THIS WAS THE FIRST TIME THE EMPLOYEE USED THIS TYPE AND MODELS OF MASK. THE EMPLOYEE HAD WORN THE MASK FOR 15-20 MINUTES. EMPLOYEE WAS TREATED FOR AN ANAPHYLACTIC REACTION IN THE EMERGENCY ROOM IMMEDIATELY FOLLOWING THE INCIDENT. THE EMPLOYEE WAS ALSO TREATED FOR COUGHING AND WHEEZING ON FOUR DIFFERENT DATES FOLLOWING THE INITIAL INCIDENT ON 2/15/95. PT TO ER AFTER WEARING MASK DEVELOPED REDNESS AND TINGLING AND SWELLING OF THE LIPS, EYES SWELLING AND ITCHING. NO SHORTNESS OF BREATH, LUNGS CLEAR TO AUSCULTATION BILATERALLY. EMPLOYEE HAD WORN THE MASK FOR ABOUT 15-20 MINUTES WHILE CHANGING AN ISOLATION PT'S BED. WHILE IN ER, SHE HAD PROGRESSIVE EYE SWELLING AND ITCHING. SHE WAS TREATED WITH BENADRYL 25 MGM (IM) AT 1140; EPINEPHRINE .5 MGM (SQ) @ 1215; SOLU CORTEF 125 MGM (IV). HOME @ 1410 ON PREDNISONE 60 MGM (PO) DAILY X 7 DAYS AND BENADRYL 25 MGM QID PRN. 2/24/95-COUGHING AND WHEEZING; TO ER FOR COUGH RX. GIVEN BENADRYL SYR. NO SIGNIFICANT DYSPNEA, PER DR'S NOTE. NO HISTORY OF REACTIVE AIRWAY DISEASE. CHEST X-RAY RELATED TO THE MASK. HOME @ 2120 ON PROVENTIL INHALER AND TOLD TO RETURN PRN WHEEZING. WAS TREATED IN ER WITH SOLUCORTEF 125 MGM IM AND A BREATHING TREATMENT. 2/26/95 @ 0900-TO ER WITH WHEEZING. TREATED WITH ALBUTEROL TREATMENT X 2. HOME @ 1030 WITH URI/RAD. 2/27/95 @ 0915-TO ER WITH WHEEZING. DR FOUND CHEST WITH DIFFUSE WHEEZING. TREATED WITH ALBUTEROL. HOME @ 1015 WITH ASTHMACIRT AND ALBUTEROL, AND ERYTHROMYCIN 250 MGM QID. NOTE HAS ALLERGIES TO MELLARIL, BEE STINGS, ADHESIVE TAPE, MORPHINE, AND CODEINE.
THE GUIDE WIRE UNRAVELED IN PT DURING PLACEMENT. THE PHYSICIAN WAS UNABLE TO REMOVE THE WIRE INTACT, LEAVING A FRAGMENT INSIDE THE PT.
FACILITY ALLEGES: INTO 3.5 HRS OF TREATMENT, BLOOD IS NOTED TO BE DRIPPING FROM THE ARTERIAL LINE AT THE BLOOD PUMP SEGMENT, CAUSING AN ESTIMATED BLOOD LOSS OF LESS THAN 100CC. FACILITY REPORTED UPON EXAMINATION, IT WAS NOTED THAT THE BLOOD PUMP SEGMENT OF THE ARTERIAL LINE HAD DOUBLED OVER DURING TREATMENT AND CRACKS WERE NOTED IN THIS AREA. PT WAS ADMITTED TO THE HOSP LATER ON THE SAME DAY WITH A DIAGNOSIS OF HEMOLYSIS.
THE RETURNED SAMPLE WAS VISUALLY EXAMINED. TWO SMALL NEARLY SYMMETRICAL SPLITS WERE FOUND ON THE PUMP SEGMENT. IT WAS NOTED ON THE COMPLAINT REPORT THAT THE BLOOD PUMP SEGMENT OF TEH ARTERIAL LINE HAD DOUBLED OVER DURING TREATMENT AND CRACKS WERE NOTED IN THIS AREA". COMPLAINTS OF THIS NATURE HAVE BEEN INVESTIGATED UNDER FIR93009. THIS TYPE OF OCCURRENCE IS THE RESULT OF INCORRECT SET UP OF THE PUMP SEGMENT INTO THE PUMP ROTOR ASSEMBLY. IN THIS PARTICULAR CASE THE EXCESS TUBING OT FOLDED AND WAS PINCHED BETWEEN THE PUMP HOUSING AND THE ROLLERS. THE SYMMETRICAL CRACKS ISOLATES ONE MOST LIKELY SIDES OF THE BINCHAD SEGMENT. NMC'S BEST INFO STATES THAT KNIKS IN MAIN BLOODLINE MUST BE VERY SEVERE (>85% SECLUDED AT BLOOD TEMP) TO CAUSE HEMIOLYSIS. WE RECOMMEND FACILITY TO REVIEW THE SECTION ENTITLED "BLOODLINE SET-UP PRECAUTIONS" IN THE PRODUCT INSERT.
PT HAD BLADDER SPASMS DURING NIGHT, AND FELT "POP". DR REMOVED FOLEY AND BALLOON. DR FELT ENTIRE BALLOON WAS PRESENT.
PT IN DIALYSIS LOST CONSCIOUSNESS AND STOPPED BREATHING AFTER TREATMENT. CATHETER SEPARATED AT 'Y' FITTING. SEVERE BLOOD LOSS. CODE 3 CALLED AND PT MOVED TO ICU. LATER RETRIEVED REMAINING PARTS OF BROKEN CATHETER.
TOTAL KNEE COMPONENTS WERE REVISED DUE TO INFECTION. NO COMPONENTS WERE REPLACED AT THIS TIME.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVAL: THIS DEVICE CAN NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED TO CO. THE CATALOG NUMBERS AND LOT CODES HAVE NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENT IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE, CATALOG NUMBER AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL. THE INFO PROVIDED SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH PT INFECTION.
THE NURSING STAFF WERE HAVING DIFFICULTIES WITH THE INFUSION PUMP AND INADEQUATE FLOW INDICATORS. THE DECISION WAS MADE TO RESTART THE INFUSOR AT ANOTHER SITE. AS THE NURSE WAS REMOVING THE DEVICE FROM THE PT, SHE DISCOVERED THAT THE NEEDLE HAD NOT COME OUT WITH THE REST OF THE DEVICE. SHE PALPATED THE PT'S ABDOMEN AND FOUND THAT THE NEEDLE HAD BROKEN OFF IN THE PT'S SUBCUTANEOUS TISSUE. THE PT WAS SENT TO THE EMERGENCY DEPARTMENT. THIS REQUIRED AN INCISION AND THREE STAPLES.
PT INFORMED DOCTOR ON 9/3/96 THAT RIGHT EYE WAS RED PAINFUL AND SENSITIVE TO LIGHT. PT REMOVED LENS PREVIOUS NIGHT AND IT FELT AS IF IT HAD BEEN SCRATCHED. WATER CONTENT: 5%, LOT # UNK . EYE INVOLVED; OD, REFRACTION: MYOPIA. TOTAL DURATION OF USE (MONTHS) NUMBER OF DAYS LENS WORN 2, LAST VISIT TO DOCTOR PRIOR TO SYMPTOMS 1/16/96. LENS CARE SYSTEM USED: CHEMICAL. DISINFECTING SYSTEM USED. HOMEMADE SALINE USED. NUMBER DAYS WORN BETWEEN CLEAN AND DISINFECTING 1-2. NUMBER DAYS BETWEEN CLEANING AND SYMPTOMS 1. NUMBER DAYS BETWEEN SYMPTOMS AND CALLING DOCTOR 1. SELF TREATMENT BY PT. YES. USED LENS CLEANER. HAND WASHING BEFORE LENS MANIPULATION, UNK. ULCER LOCATION 6'O CLOCK; VISUAL ACUITY BEFORE SYMPTOM 20/16; VISUAL ACITY AFTER SYMPTOMS: 20/15-1 OU WITH SPECS. RESULTS OF CULTURE: NONE TAKEN. RESULTS OF CORNEAL BIPOSY AND/OR SCRAPINGS.: N/A: CLINICAL DIAGNOSIS: ULCERATIVE KERATTIS. TREATMENT ADMINISTERED: CILOXAN, TOBRAMYCIN, HOMATROPINE.
ADD'L INFO SUBMITTED?. NO. IS THE EVENT FREQUENCY ADDRESSED IS PRODUCT LABELING? NO. IF "Y" IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? IS EVENT OCCURING MORE FREQUENTLY THAN USUAL? NO. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO. FACILITY REGISTRATION NUMBER 9681121 WILL BE THE DESIGNATED FACILITY REGISTRATION NUMBER.
RESIDENT WAS IN SHOWER ROOM, SITTING IN SHOWER CHAIR. HE MOVED TRYING TO ADJUST SITTING POSITION AND WHEEL OF CHAIR CAME OFF CAUSING PT TO SLIDE TO FLOOR.
REVISION SURGERY REVEALED THE ELBOW PROSTHESIS "DISARTICULATED".
REQUESTS TO OBTAIN THE DEVICE OR DEVICE INFO FROM USER FACILITY HAVE BEEN UNSUCCESSFUL. A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED BECAUSE THE DEVICE CATALOG NUMBER AND LOT CODE ARE UNK. IF THE DEVICE IS RETURNED TO CO, THIS PRODUCT EXPERIENCE REPORT WILL BE REOPENED AND A COMPLETE EVAL WILL BE PERFORMED.
PT EXPERIENCED SEVERE TENDERNESS AND PAIN AT SITE OF PREVIOUS SURGERY - 11/93 PATELLA, FEMORAL AND TIBIAL IMPLANT. SURGERY ON 8/14/96 REDUCED DIAMETER OF KNEE CAP, REPLACED PATELLA FROM ORIGINAL SURGERY AND REMOVED SYNOVIAL TISSUE. SYNOVIAL TISSUE WAS DARK - DR WAS CONCERNED AS TO CAUSE - WAS THERE ANY ABRASIVE WEAR OF FEMORAL COMPONENT.
EXTENSION TUBE ON EXTERNAL INFUSION PUMP ADMINISTERING FLUOROURACIL DEVELOPED A HOLE AND LEAKED. IT WAS REPORTED TO HOME HEALTH NURSE AT 5:00 AM. THE DRUG WAS STOPPED AT 5:20 AM AND A NEW TUBE WAS ATTACHED AND STARTED AGAIN AT 9:00 AM. NO PT INJURY WAS SUSTAINED.
PT EXPERIENCED SEVERE TENDERNESS AND PAIN AT SITE OF PREVIOUS SURGERY - 11/93 PATELLA, FEMORAL AND TIBIAL IMPLANT. SURGERY ON 8/14/96 REDUCED DIAMETER OF KNEE CAP, REPLACED PATELLA FROM ORIGINAL SURGERY, AND REMOVED SYNOVIAL TISSUE. SYNOVIAL TISSUE WAS DARK. DR WAS CONCERNED AS TO CAUSE. WAS THERE ANY ABRASIVE WEAR OF FEMORAL COMPONENT.
CONCLUSION STATEMENT. UNABLE TO CONFIRM COMPLAINT. DEVICE HISTORY RECORD DOCUMENTS DEVICE IS WITHIN SPECIFICATIONS.
THE CUSTOMER REPORTED THAT IF YOU TILT THE UNIT FROM SIDE TO SIDE, IT STOPS WORKING. REPORTEDLY, WHEN THE CUSTOMER WAS TESTING THE UNIT IN THIS MANNER, SPARKS CAME OUT OF THE UNIT. THE UNIT WAS NOT BEING USED ON A PT AND NO INJURY OCCURRED.
THIS EVENT WAS REPORTED AS: REGURGITATION AND "FAILURE". NO FURTHER INFO AVAILABLE.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA. THE PATELLA WAS REMOVED AND NOT REPLACED.
THIS IS THE SAME PT/EVENT AS MFR# 2219689-1996-00073. SUMMARY OF EVALUATION: AS RECEIVED, THE TIBIAL INSERT EXHIBITS MODERATELY HEAVY WEAR ON BOTH CONDYLES WITH A PIECE BROKEN OUT OF THE MEDIAL POSTERIOR REGION. THE WEAR PATTERN SUGGESTS A SLIGHT VARUS MALALIGNMENT. THE PATELLAR COMPONENT IS DISASSOCIATED WITH THE PLASTIC SHOWING HEAVY WEAR AND WEAR-THROUGH INCLUDING A TRANSVERSE CRACK ON THE LATERAL SIDE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH COMPONENTS FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFG. THE INFO PROVIDED AND THE EXAMINATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALIGNMENT.
REGURIGATION, PERIVALVULAR LEAK AND VALVE DEHISCED FROM THE ANNEEBUS.
A PIECE OF THIS SILICONE TUBING WAS PLACED IN THE ANTERIOR CHAMBER OF THE EYE AND THE EXTERNAL PART PLACED UNDERNEATH THE SCLERAL BUCKLE DURING A SHOCKETT PROCEDURE ON 12/13/93. ABOUT ONE MONTH AGO THE TUBING APPEARED TO BE MIGRATING FORWARD INTO THE EYE. WHEN AN ATTEMPT WAS MADE TO REPOSITION THE TUBING ON 3/20/95, IT WAS NOTED THAT THE TUBING HAD GOTTEN LONGER. WHEN THE TUBING WAS TOUCHED WITH THE FORCEPS, IT DISINTEGRATED. SOME OF THE TUBING WAS REMOVED. THIS TUBING IS PURCHASED IN 10' LENGTHS AND USED IN VERY SMALL PIECES. PHYSICIAN HAS REQUESTED ANALYSIS OF THIS TUBING TO DETERMINE IF IT HAD BEEN PROPERLY CURED.
THIS EVENT WAS REPORTED AS: MALFUNCTION NO FURTHER INFO AVAILABLE.
REVISION SURGERY REVEALED BREAKAGE OF THE TIBIAL BASEPLATE, AS WELL AS, POLYETHYLENE WEAR OF THE INSERT AND PATELLA.
SUMMARY OF EVALUATION: EVALUATION RESULTS INDICATE THAT THIS EVENT IS ASSOCIATED WITH MALALIGNMENT AND LACK OF CORTICAL SUPPORT.
THE CATHETER WAS INSERTED INTO THE PT AT APPROX. 11:32 HRS.  AN X-RAY WAS TAKEN AT THAT TIME AND EVERYTHING WAS FINE. AT 14;29 HRS A SECOND X-RAY INDICATED THE CATHETER HAD KINKED SEVERLY, THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER ONE.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED WITH A 00-5220-012-00.
THIS EVENT WAS REPORTED AS: DETERIORATED AND PT HAD SVC FAILURE. NO FURTHER INFO AVAILABLE.
ON 9/6/96, THE FACILITY OR MATERIAL MGR CONTACTED THE MFR AND REPORTED THAT THE PT'S NECK HAD SWOLLEN DURING CHEMOTHERAPY. IT WAS ADDITIONALLY STATED THAT THE CHEMO WAS NOT REMOVED FROM THE DEVICE; THE SWELLING WAS NOTICED DURING FLUSHING OF THE DEVICE. A FLUOROSCOPY WAS PERFORMED AND REVEALED LEAKAGE FROM THE DEVICE CATHETER AT THE "CURVE BEFORE ENTERING THE INTERNAL JUGULAR." NO FURTHER INFO IS AVAILABLE AT THIS TIME.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: RECEIVED IS A SINGLE LUMEN TITANIUM DEVICE WITH AN ATTACHABLE 10 FR SILICONE CATHETER AND BAYONET LOCK AS REPORTED. THE DEVICE CATHETER HAD BEEN CUT APPROX 3/4" FROM THE PORT STRAIN RELIEF. TWO LOOSE SEGMENTS OF CATHETER WERE ALSO RECEIVED. NORMAL USAGE WAS INDICATED ON THE DEVICE SEPTUM WITH NO INTERNAL FRACTURE PLANE DAMAGE FOUND. THE DEVICE CATHETER, WHICH HAD BEEN CUT INTO THREE SEGMENTS, APPEARED TO HAVE BEEN CUT BY A SHARP OBJECT SUCH AS A BLADE. ALL CATHETER ENDS SHOWED UNEVENLY CUT MATERIAL. HOLES, CUTS, TEARS OR COMPRESSION WERE NOT SEEN ON THE DEVICE CATHETER. THE DEVICE AND CATHETER SEGMENTS WERE PATENT AND DID NOT LEAK WHEN PRESSURIZED TO 60 PSI. NO OTHER DEFECTS OR ANOMALIES WERE FOUND DURING ANALYSIS. AS PART OF CO'S INVESTIGATION OF THIS EVENT A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. IN CONCLUSION, THE REPORT OF DEVICE LEAKAGE IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE, AND THE DEVICE ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
PT COMPLAINED OF DISCOMFORT AND CLICKING ON 3/15/95. TWO TABS ON THE CUP HAD BROKEN OFF AND THE LINER HAD BECOME DISPLACED FROM THE CUP.
REGURGITATION AND SOME DEGRADATION AT COMMISURES.
H3: EXAMINATION OF THE VALVE IN LABORATORY REVEALED CALCIFICATION WITHIN EACH CUSP WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE LEAFLET DISRUPTIONS AND INCOMPLETE COAPTATION. HOST TISSUE OVERGROWTH ENCROACHED ONTO EACH LEAFLET, CONTRIBUTING TO STENOSIS OF THE VALVE. X-RAY ANALYSIS REVEALED CALCIFICATION WITHIN THE AORTIC WALL, BELLY AND FREE MARGIN OF EACH CUSP. STENT DISTORTION WAS ALSO NOTED WHICH APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO CALCIFICATION. THIS FINDINGS WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY. H6: 86=X-RAY ANALYSIS.
STEM EXTENSION BROKE AT THREADED END. OTHER DEVICE USED WAS 00-5114-044-21.
DURING WITHDRAWAL, THE CATHETER TIP BROKE OFF. THE PRODUCT WILL NOT BE RETURNED.
REPORT RECEIVED FROM EUROPEAN OPERATIONS INDICATED THAT A 82 YR OLD MALE PT WAS UNDERGOING AN ILIAC ARTERY ANGIOGRAPHY. DURING WITHDRAWAL OF THE CATHETER, THE PHYSICIAN FELT RESISTANCE AND THE TIP OF THE CATHETER FRACTURED IN THE BIFURCATION OF THE AORTA. THE PT WAS TRANSFERRED TO ANOTHER HOSP AND THE TIP WAS RETRIEVED UNEVENTFULLY. THE PT'S CONDITION WAS REPORTED AS SATISFACTORY AND WAS DISCHARGED FROM THE HOSP. REPORTEDLY, THE PRODUCT WILL NOT BE RETURNED. THIS FILE IS CONSIDERED CLOSED. SHOULD THE PRODUCT BE RETURNED AT A LATER DATE, A FOLLOW-UP WILL BE SUBMITTED FOR REVIEW.
PT HAD INITIAL LAPAROSCOPIC SURGERY ON 11/15/94. PT RETURNED ON 11/26/94 AND REQUIRED SURGERY FOR RELEASE OF ADHESIONS AND SMALL BOWEL OBSTRUCTION. SURGEON'S NOTE STATES: AT THE POINT OF OBSTRUCTION, THERE WAS A SINGLE TINY STAPLE WHICH WAS IN THE MESENTERY OF THE SMALL BOWEL RIGHT BELOW WHERE THE POINT OF OBSTRUCTION WAS VISIBLE. THE SIGNIFICANCE OF THIS SMALL STAPLE IS NOT KNOWN, BUT IT ADDS TO THE POSSIBILITY OF THE BOWEL BEING KINKED ON AN ACCESS CREATED BY THE EXTENT OF THE STAPLING OF THE MESENTERY TO THE POINT OF UTERINE RESECTION. SURGEONS HAVE STATED THAT INCOMPLETE CLOSURE OF THE STAPLES WHEN FIRED AND "DROPPING OFF" OF STAPLES HAS OCCURRED AND BEEN REPORTED TO THE MFR. IT IS UNKNOWN IF THIS STAPLE WAS THE CAUSE OF THE SINGLE ADHESION WHICH FORMED IN THE POSTOPERATIVE PERIOD FOLLOWING THE LAVH.
DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OF SEVERITY IS EITHER UNKNOWN OR UNAVAILABLE.
THE DEVICE WAS IMPLANTED ON 5/2/95 FOR INTRATHECAL INFUSION OF MORPHINE. NOTE: INTRATHECAL INFUSION OF MORPHINE WAS NOT A MFR'S INDICATION FOR THE DEVICE'S INTENDED USE. ON 8/28/96, THE FACILITY NURSE CONTACTED A MFR NURSE AND REPORTED THAT A DEVICE CATHETER REVISION HAD BEEN PERFORMED IN 9/95, DUE TO DISPLACEMENT. THE MORPHINE SULFATE DOSAGE HAS BEEN GRADUALLY INCREASED SINCE THAT TIME FROM 2MG/ML; HOWEVER, THE PT IS STILL NOT EXPERIENCING PAIN RELIEF. THE FACILITY NURSE STATED THAT IN VIEWING THE PT'S CHART, SHE NOTED THAT A CT SCAN WHICH WAS DONE IN 11/95 COULD NOT TELL THE EXACT POSITION OF THE CATHETER AND IT WAS SUGGESTED AT THAT TIME THAT A FLUOROSCOPIC DYE STUDY BE PERFORMED; HOWEVER, ONE HAS NEVER BEEN DONE. THE FACILITY NURSE ALSO STATED THAT THE DEVICE FLOW RATE APPEARS TO BE "OKAY", HOWEVER, SHE HAS ONLY REFILLED THE DEVICE ONE TIME. THE PT'S PREVIOUS PHYSICIAN IS DECEASED. THE NEW PHYSICIAN WILL BE AVAILABLE ON 9/3/96 AND THE FACILITY NURSE STATED THAT SHE WOULD BRING THIS TO HIS ATTENTION AND TRY TO HAVE A DYE STUDY PERFORMED BEFORE THE PT'S NEXT SCHEDULED VISIT WHICH IS THE SECOND WEEK IN OCT.
ON 10/15/96, THE FACILITY NURSE REPORTED THAT THE PATIENT IS STILL EXPERIENCING PAIN. THE DEVICE WAS SCHEDULED TO BE REFILLED AGAIN ON 10/16/96 AND THE DOSAGE WOULD BE INCREASED AT THAT TIME. THE FACILITY NURSE ALSO STATED THAT THE PATIENT HAD BEEN REFERRED TO A NEUROSURGEON AND SHE DID NOT BELIEVE THAT A DYE STUDY HAD BEEN PERFORMED YET. ON 10/31/96, THE FACILITY NURSE REPORTED THAT THE DEVICE HAD BEEN REFILLED ON 10/16/96 AND THE DOSAGE WAS INCREASED AS PLANNED; HOWEVER, THE PATIENT IS STILL EXPERIENCING INADEQUATE PAIN RELIEF. THERE DID NOT APPEAR TO BE ANY DEVICE FLOW RATE ISSUES AND A DYE STUDY HAD NOT YET BEEN PERFORMED. THE FACILITY NURSE STATED THAT THE PATIENT HAD BEEN REFERRED TO A NEUROSURGEON WHO SAW THE PATIENT ONCE BEFORE TRANSFERRING TO ANOTHER FACILITY. IN ADDITION, THE FACILITY NURSE STATED THAT IT IS NOT KNOWN WHO THE PATIENT IS NOW BEING SEEN BY. THE MFR INQUIRED IF THE FACILITY NURSE IS CONTINUING TO PERFORM THE PATIENT'S DEVICE REFILLS AND THE FACILITY NURSE RESPONDED THAT SHE DID NOT HAVE A DEVICE REFILL SCHEDULED FOR THIS PATIENT AT THE PRESENT TIME; HOWEVER, IF REQUESTED SHE WILL PERFORM THE DEVICE REFILLS. IN ADDITION, THE FACILITY NURSE STATED THAT IT MAY BE SIX WEEKS OR LONGER BEFORE SHE HEARS ANYTHING FURTHER CONCERNING THIS PATIENT. SINCE FOLLOW UP INFO CONCERNING THE CURRENT STATUS OF THIS PATIENT/DEVICE IS NOT AVAILABLE AND IT IS NOT KNOWN WHEN FOLLOW UP INFO WILL BE RECEIVED, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PART/SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS PART/SERIAL NUMBER AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS PART NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. BASED ON THE AVAILABLE INFO AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOT CLOSING ITS FILE ON THIS EVENT. THE MFR HAS INFORMED THE FACILITY NURSE THAT SHOULD ADDITIONAL INFO BECOME AVAILABLE CONCERNING THE STATUS OF THIS PATIENT/DEVICE, OR SHOULD THE DEVICE BE EXPLANTED AND BECOME AVAILABLE FOR ANALYSIS, THEN THE MFR WILL REOPEN ITS INVESTIGATION OF THIS EVENT.
FAMILY MEMBER REPORTS THAT DIABETIC WAS HOSPITALIZED AND GIVEN IV GLUCOSE FOR A HYPOGLYCEMIC EVENT. THE DEVICE HAD BEEN PROVIDING ELEVATED BLOOD GLUCOSE RESULTS FOR SEVERAL DAYS. THE DIABETIC HAD BEEN WITH HOLDING FOOD INTAKE BASED ON DEVICE RESULTS. HOSP EVALUATED DEVICE AND DETERMINED THAT TEST STRIPS WERE DAMAGED. DIABETIC HAD QUALITY CONTROL SOLUTIONS BUT HAD NEVER USED THEM TO CHECK THE DEVICE.
DURING AN ARTHROSCOPY OF THE KNEE, A PIECE OF MENISCUS WAS BEING REMOVED WHEN THE LOWER JAW OF THE ARTHROSCOPIC GRASPER BROKE OFF INTO THE SURGICAL SITE. ADD'L SURGERY WAS DONE TO REMOVED THE FOREIGN BODY.
USER PURCHASE RECORDS INDICATE DEVICE HAS BEEN IN SVC 5 OR MORE YRS. PROBABLE CAUSE OF BREAKAGE IS ROUTINE WEAR AND TEAR.
SPOUSE OF ELDERLY DIABETIC REPORTED A HYPOGLYCEMIC EVENT WHICH LED TO HOSPITALIZATION OF THE DIABETIC. NO INFO WAS AVAILABLE ON THE TREATMENT REC'D. THE DEVICE HAD BEEN PROVIDING ELEVATED BLOOD VALUE PRIOR TO THE EVENT. AN ADD'L 5 UNITS OF INSULIN WAS ADMINISTERED IN THE EVENING PRIOR TO THE EVENT AS DIRECTED BY PHYSICIAN. THE DIABETIC HAD NOT BEEN STORING THE TEST STRIPS AS DIRECTED IN THE LABELING. QUALITY CONTROL CHECKS AFTER THE EVENT INDICATED THAT THE STRIPS WERE DAMAGED. LABELING CLEARLY INDICATES THAT UNUSUALLY HIGH RESULTS CAN BE CAUSED BY STORING THE STRIPS IN THE VIAL WITHOUT CAP BEING TIGHTLY SEALED.
A PT WAS ON MORPHINE SULFATE WHILE USING THE PUMP AND EXPERIENCED AN EPISODE OF RESPIRATORY DISTRESS, WITH A DECREASE IN RESPIRATION REQUIRING INTUBATION. THE PT STATED WHEN HE RECOVERED THAT SOMETHING MALFUNCTIONED WITH THE PUMP, "IT WAS ALARMING, BEEPING", PRIOR TO THIS EVENT.
EVALUATION RESULTS RECEIVED FROM OUTSIDE CONTRACTOR FOR REPORTING HOSPITAL. THIS REPORT CONCLUDED THE FOLLOWING, "ALL CONTROL, SAFETY, AND ALARM FEATURES FUNCTION CORECTLY AND THIS PUMP MEETS OR EXCEEDS THE MANUFACTURER'S SPECIFICATIONS.
ON 10/28/96 AN INCIDENT OCCURRED INVOLVING A PORT. APPROX. 3 WEEKS POST-PLACEMENT IT WAS NOTED THE CATHETER HAD DISCONNECTED FROM THE PORT AND MIGRATED TO THE PULMONARY ARTERY. RETRIEVAL OF THE CATHETER UTILIZING A SNARE WAS UNEVENTFUL. ANOTHER PORT WAS NOT PLACED AND THE PT'S CONDITION IS GOOD. CO'S PRELIMINARY INVESTIGATION SUGGESTS INAPPROPRIATE CATHETER CONNECTION DURING PLACEMENT MAY HAVE CONTRIBUTED TO THE EVENT. THE DEVICE IS CURRENTLY BEING EVALUATED. UPON COMPLETION OF THE ENGINEERING EVAL A SUPPLEMENTAL REPORT WILL BE FORWARDED UNDER 1221409-1996-00001. THE DIRECTIONS FOR USE FOR THIS PRODUCT STATE: "IMPROPER ASSEMBLY MAY RESULT IN CATHETER DAMAGE, LEAKAGE OR POSSIBLE DISCONNECTION. WHEN PROPERLY ASSEMBLED, THE PORT'S LOCKING COLLAR SHOULD BE FULLY ENGAGED INTO THE OUTLET TUBE GROOVE AND CATHETER SHOULD BE VISIBLE THROUGH THE LOCKING COLLAR SLOTS." NO PT INFO WAS AVAILABLE DUE TO PT CONFIDENTIALITY.
THE DEVICE WAS RETURNED FOR EVALUATION. OUR EVALUATION WASN'T ABLE TO DUPLICATE THE CUSTOMER'S PROBLEM. HOWEVER, WE BELIEVE THAT THE PROBLEM IS CONSISTENT WITH CATHETER KINKING. A KINKED CATHETER, AND PERHAPS PRECIPITATES FROM INCOMPATIBLE DRUG BOLUS, THROMBUS OR SHEATH FORMATION AT OR AROUND THE TIP MAY ALLOW A BOLUS FLUSH BUT INTERFERE WITH THE PUMP FLOW.
WHILE BEING MONITORED ON AN M2360A COMPONENT CENTRAL MONITOR, THE PT CODED AND EXPIRED. THE STAFF SAID THAT THE SYSTEM DIDN'T ALARM.
CO WENT TO THE SITE AND TESTED THE PRODUCT. NO PROBLEM WAS FOUND. THE ALARM REPORT SHOWS SEVERAL ALARMS, BUT ALL WERE AUTO RESET. THE STAFF SAID THEY DON'T VALIDATE TWO STAR ALARMS. THERE IS AN APPLICATION PROBLEM AT THIS SITE. THE STAFF NEEDS ADD'L TRAINING AND CO IS MAKING ARRANGEMENTS TO HAVE THE STAFF TRAINED.
TWO POLYPECTOMY PROCEDURES WERE INITIALLY PERFORMED WITHOUT INCIDENT. A FEW DAYS POST PROCEDURE BOTH PTS RETURNED WITH RECTAL BLEEDING. ONE PT WAS READMITTED TO ANOTHER HOSP AND NO FURTHER DETAILS ARE AVAILABLE. THE SECOND PT WAS ADMITTED AND RETREATED. THE PT'S CONDITIONS ARE GOOD. NO FURTHER DETAILS ARE AVAILABLE WITH REGARDS TO THE CIRCUMSTANCES SURROUNDING THESE EVENTS. THE BIOMED DEPT AT THE USER FACILITY EVALUATED THE GENERATOR AND STATED THE SETTINGS WERE OUT OF CALIBRATION. THE DEVICE WAS THEN RETURNED, REC'D AND EVALUATED. MECHANICAL AND PERFORMANCE TESTING FOUND THE DEVICE WITHIN SPECS FOR ALL MODES AND TESTED SETTINGS. NO ELECTRICAL PROBLEMS WERE FOUND AND THE UNIT FUNCTIONED AS INTENDED. THE UNIT FUNCTIONED AS INTENDED AND ALL SETTINGS WERE WITHIN SPEC. USER TECHNIQUE MAY HAVE CONTRIBUTED TO THIS EVENT, HOWEVER, WITHOUT FURTHER DETAILS CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. NO PT INFO WAS AVAILABLE DUE TO PT CONFIDENTIALITY.
F10: 2200 (OTHER) PROCEDURE PERFORMED WITHOUT INCIDENT 2203 (OTHER) NO MALFUNCTION OF DEVICE REPORTED DURING PROCEDURE.
THE DEVICE WAS IMPLANTED ON 8/9/96, FOR THE INFUSION OF FUDR THROUGH THE HEPATIC ARTERY FOR TREATMENT OF CANCER. ON 8/27/96, A FACILITY NURSE CONTACTED THE MFR'S CLINICAL SPECIALIST. THE FACILITY NURSE STATED THAT AT THE FIRST DEVICE REFILL ON 8/23/96, 35CC OF SEROUS FLUID WAS ASPIRATED FROM A SEROMA OF THE DEVICE POCKET. THE FACILITY NURSE STATED SHE WAS UNABLE TO SUCCESSFULLY ACCESS THE DEVICE RESERVOIR AND THE DEVICE WAS EASILY MOVABLE IN THE DEVICE POCKET. THE DEVICE WAS ACCESSED BY THE SURGEON, WHO DETERMINED THAT THE DEVICE WAS APPROPRIATELY POSITIONED. ON 8/27/96, PRIOR TO ACCESSING THE DEVICE, THE FACILITY NURSE CONTACTED THE MFR'S CLINICAL SPECIALIST AND REQUESTED TO KNOW HOW A "FLIPPED DEVICE" COULD BE IDENTIFIED. THE FACILITY NURSE AND THE MFR'S CLINICAL SPECIALIST DISCUSSED FACTORS, INCLUDING X-RAY CONFIRMATION. LATER THAT DAY (8/27/96), THE FACILITY NURSE CONTACTED THE MFR'S CLINICAL SPECIALIST AGAIN AND INFORMED HER THAT THE PT'S DEVICE POCKET REMAINED EDEMATOUS AND SHE HAD ASPIRATED 200CC OF SEROUS FLUID FROM THE DEVICE POCKET. ADDITIONALLY, SHE STATED THAT SHE ATTEMPTED TO ACCESS THE DEVICE RESERVOIR, BUT WAS UNABLE TO LOCATE THE DEVICE SEPTUM. THE PT WAS SENT TO X-RAY FOR A LATERAL VIEW OF THE DEVICE. THE RADIOLOGIST REPORTED THAT THE DEVICE SEPTUM APPEARS TO FACE THE FASCIA, WITH THE SMOOTH BOTTOM SURFACE OF THE DEVICE NEXT TO THE PT'S SKIN. THE FACILITY NURSE REQUESTED A MFR NURSE BE PRESENT IN THE OFFICE TO OBSERVE PALPATION OF THE DEVICE AND TO VIEW THE X-RAY. LATER THAT DAY (8/27/96), A MFR CLINICAL REP WAS PRESENT IN THE OFFICE TO SUPPORT THE RADIOLOGIST'S READING OF THE X-RAY. THE SURGEON WAS NOT AVAILABLE; HOWEVER, THE SURGEONS PARTNER/ASSOCIATE REVIEWED THE CLINICAL AND X-RAY INFO. AS A RESULT, THE PT WAS SCHEDULED FOR A DEVICE POCKET EXPLORATION ON 8/28/96.
ON 10/21/96, THE FACILITY NURSE CONTACTED A MFR REP. AND STATED THAT SHE HAS RECEIVED THE MFR'S CLOSE LETTER AND WISHES TO INFORM THE MFR OF A FEW DISCREPANCIES IN THE CONTENTS OF THE CLOSE LETTER. 1) IT WAS STATED THAT THE DEVICE WAS ACCESSED BY THE SURGEON, WHO DETERMINED THAT THE DEVICE WAS APPROPRIATELY POSITIONED. THIS SHOULD HAVE READ, THE SURGEON DETERMINED BY PALPATING THE DEVICE, THAT THE DEVICE WAS APPROPRIATELY POSITIONED. 2) ON 8/28/96, THE MFR'S SALES REP. WAS PRESENT FOR DEVICE POCKET EXPLORATION SURGERY. DUE TO THE FACT THAT THERE WAS NO SURGERY INVOLVED, THIS SHOULD HAVE READ, ON 8/28/96, THE MFR'S SALES REP. WAS PRESENT WHEN THE SURGEON MANUALLY FLIPPED THE DEVICE BACK INTO A UPRIGHT POSITION. 3) 50,000U/50ML OF HEPARIN WAS INSTILLED INTO THE DEVICE. THIS SHOULD HAVE READ, 50,000U/50ML HEPARIN/NORMAL SALINE WAS INSTILLED INTO THE DEVICE. THE MFR'S REP. APOLOGIZED TO THE FACILITY NURSE AND INFORMED HER THAT THE LETTER ONLY CONTAINED THE INFO PROVIDED TO HER. THE FACILITY NURSE STATED THAT SHE HAD NO PROBLEMS NOR WAS SHE UPSET; HOWEVER, SHE THOUGHT THE MFR WOULD LIKE TO HAVE THE CORRECTED INFO SO THE FILE WOULD BE ACCURATE. ADDITIONALLY, THE  FACILITY NURSE STATED THAT NEITHER SHE OR THE PHYSICIAN REQUIRE ANOTHER LETTER WITH THE CORRECTED INFO. THE CORRECTED INFO PROVIDED DID NOT CHANGE THE OUTCOME OF THE INVESTIGATION/ORIGINAL FILE; THEREFORE, THE FILE WILL REMAIN CLOSED AND THE COMMUNICATION REPORT AND THIS CORRECTED FOLLOW-UP (01) WILL BE ADDED TO THE FILE. NO FURTHER DETAILS ARE AVAILABLE. THE MFR'S FILE WILL REMAIN CLOSED.
DURING DIRECTIONAL ATHRECTOMY OF A RCA THE GUIDEWIRE FRACTURED AND BECAME LODGED IN A DISTAL BRANCH OF THE RCA. THE PHYSICIAN DECIDED TO LEAVE THE RETAINED FRAGMENT IN THE VESSEL. THE PT HAS BEEN DISCHARGED HOME IN GOOD CONDITION. THE HOSP IS HOLDING THE WIRE.
THIS EVENT WAS CALLED INTO THE DEVICE MFR. F10: PT CODES 2202. DEVICE CODES: 1638.
WHILE THE PT WAS BEING MONITORED BY THE M1046A COMPONENT MONITORING SYSTEM, THE M1043-68001 INTERNAL RACK WHICH LOCKS INTO THE COMPUTER MODULE CAME APART. THE FRONT END ASSEMBLY WITH MODULES SEPARATED FROM THE REAR COVER AND FELL UPON THE PT. THE FRONT END ASSEMBLY TURNED IN MID-AIR IN SUCH A MANNER THAT THE CIRCUIT CARD STRUCK THE PT ON THE LEFT SIDE OF THE FACE NEAR THE JAW BONE CAUSING ABRASIONS OF THE SKIN. THE UNIT CONTINUED UNTIL IT STRUCK THE COLLAR BONE IN THE LEFT CLAVICLE AREA, CAUSING A SMALL CUT IN THE SKIN. THE PT WAS GIVEN AN X-RAY EXAMINATION. THERE WERE NO FURTHER INJURIES.
ANALYSIS: THE INTERNAL RACK WAS RETURNED TO CO FOR ANALYSIS. THE UNIT WAS RECEIVED IN TWO SEPARATE HALVES, SHOWING NO ANOMALIES OR MECHANICAL DEFECTS. ALL FOURTEEN INTERLOCKING TABS APPEARED NORMAL. THE UNIT WAS REASSEMBLED USING THE NORMAL MANUFACTURING PROCESSES. THE EVAL OF THE REASSEMBLED UNIT SHOWED NO ANOMALIES. THE RACK WAS THEN DISASSEMBLED AND MECHANICALLY INSPECTED. NO PROBLEMS WERE DISCOVERED. PULL TESTS ON THE FULLY ASSEMBLED RACK WERE UNSUCCESSFUL IN SEPARATING THE TWO HALVES. THE RACK WAS TURNED OVER TO THE MANUFACTURING ENGINEERING FOR THEIR ANALYSIS. EXPERIMENTS WERE PERFORMED TO INVESTIGATE THE POSSIBILITY THAT THE TOP SEVEN OUT OF FOURTEEN MECHANICAL INTERLOCKS WERE NOT COMPLETELY ENGAGED. THE RESULTS FROM THESE EXPERIMENTS INDICATED THAT WITH THE RACK PARTIALLY ASSEMBLED, THE ELECTRICAL INTEGRITY BETWEEN THE RACK AND RACK INTERFACE CONNECTION IS INTERRUPTED. NO COMMUNICATION BETWEEN THE RACK AND THE CMU WAS POSSIBLE IN THIS PARTIALLY ASSEMBLED STATE. CONCLUSION: THE EXPERIMENTS PERFORMED ON THE RETURNED INTERNAL RACK WERE INCONCLUSIVE. THE RACK EXHIBITED NO SIGNS OF MECHANICAL FATIGUE OR FAILURE. INTENTIONALLY MISASSEMBLING THE RACK RESULTED IN LOSS OF COMMUNICATION BETWEEN THE FRONT END MODULES AND THE CMU. THE CMS IS NOT FUNCTIONAL IN THIS MODE. EQUIPMENT INOP ALARMS WOULD BE GENERATED IN THIS MODE OF OPERATION. THE EQUIPMENT HAS BEEN IN SERVICE FOR TWO YEARS WITH NO REPORTS OF RACK SPECIFIC FAILURES. A REVIEW OF CO'S SERVICE RECORDS DOESN'T SHOW ANY SIMILAR OCCURRENCE OF THIS PROBLEM.
TIP OF RESECTOSCOPE INNER SHEATH FELL INTO PT 5/8/95, AND HAD TO BE RETRIEVE VIA SUBSEQUENT SURGERY 9/29/95.
INSTRUMENT WAS RETURNED INITIALLY WITHOUT MENTION OF A PT INCIDENT. AFTER EVAL, INSTRUMENT WAS PUT BACK INTO CO'S REPAIR/EXCHANGE PROGRAM.
PT PLACED ON INTERMITTENT DELIVERY WITH PUMP VIA PICC LINE. I.V. ANTIBIOTIC DELIVERY TIME OF EVERY 4 HRS. PUMP SET TO DELIVER AT 6-10-2-6-10. PUMP DELIVERED 6PM DOSE BUT FAILED TO DELIVER 10PM AND 2AM DOSE." CONTACT WITH THE ACCOUNT INDICATES MANY ALARMS HAD OCCURRED IN THE EVENING, SOME OF WHICH INCLUDED OCCLUSION, CHECK CARTRIDGE, STOPPED INFUSION AND MISSED DOSE. THE EVENING USER WAS NOT EXPERIENCED WITH THE DEVICE. THE INITIAL DEVICE SETTINGS WERE FOR OXACILLIN DELIVERY, 20 ML DOSE EVERY 4 HRS WITH A 1 ML/HR KEEP OPEN RATE. THE MISSED DOSES DID NOT CAUSE ANY ADVERSE PT EFFECTS.
THE PUMP TESTED WITHIN PRODUCT SPECIFICATION. REVIEW OF THE DEVICE HISTORY LOG INDICATED THE DEVICE WAS STOPPED AT 8:43 AND THEN WAS POWERED OFF AT 8:44. REPORTER SUSPECTS THE PROBLEM TO BE USER RELATED.
SUMMONS AND COMPLAINT STATES THAT SIX DAYS FOLLOWING INGUINAL HERNIA REPAIR, PT DEVELOPED INFECTION WHICH, OVER EXTENDED COURSE OF TIME, REQUIRED ADD'L MEDICAL INTERVENTION CONSISTING OF WOUND DEBRIDEMENT, DRESSING CHANGES, SUTURE REMOVAL, ANTIBIOTIC THERAPY, STEROIDAL INJECTIONS AND RE-OP TO REMOVE SUTURE GRANULOMA. CO'S INTERNAL CONTROL NUMBER IS: 9600597-00.
H7-THIS PRODUCT ALLEGED TO HAVE BEEN PART OF A PRODUCT RECALL IN 1994 WHICH HAS LITIGATION RECEIVED ON 8/26/96.
GUIDEWIRE FROM CENTRAL LINE PLACEMENT SURGICALLY REMOVED FROM INTERNAL JUGULAR VEIN.
THE DEVICE WAS IMPLANTED ON 8/26/96 REF (MDR#: 1219454-1996-00438), FOR INTRATHECAL INFUSION OF DURAMORPH FOR TREATMENT OF PAIN (NOTE: INTRATHECAL PLACEMENT OF THE DEVICE IS NOT A MFR'S INDICATION FOR THE DEVICE'S INTENDED USE). ON 9/11/96, THE PT WAS RETURNED TO THE OPERATING ROOM WITH PURULENT DRAINAGE FROM AN INCISION AT THE LUMBAR REGION OF THE SPINE FROM THE DEVICE IMPLANT SURGERY PERFORMED ON 8/26/96. THE IMPLANTING SURGEON WAS ON VACATION. A NEUROSURGEON AND THE IMPLANTING SURGEON'S PARTNER/ASSOCIATE REMOVED THE IMPLANTABLE INFUSION PUMP AND THE ATTACHED INTRATHECAL CATHETER DUE TO AN INFECTION AT THE LUMBAR REGION. THE NEUROSURGEON STATED THAT HE REMOVED SOME NECROTIC TISSUE FROM SKIN AT THE LUMBAR REGION, HE DID NOT WANT THE INFECTION TO TRACK DOWN THE INTRASPINAL CATHETER TO THE IMPLANTABLE INFUSION PUMP POCKET, SO THE NEUROSURGEON ELECTED TO REMOVE BOTH THE INTRATHECAL CATHETER AND THE IMPLANTABLE INFUSION PUMP. THE NEUROSURGEON ALSO STATED THAT HE FELT THAT THE TISSUE INFECTION WAS LOCALIZED AT THIS TIME. THE IMPLANTING SURGEON'S PARTNER/ASSOCIATE STATED IN HER PROGRESS NOTES THAT THE DEVICE WAS FUNCTIONING WITHOUT DIFFICULTY AND THE INTRATHECAL CATHETER WAS INTACT UPON REMOVAL. THE PHYSICIANS DID NOT WANT THE IMPLANTABLE INFUSION PUMP OR THE CATHETER TO BE ANALYZED SINCE THEY FELT THAT THE EXPLANT WAS DUE TO AN INFECTION AT THE LUMBAR REGION, NOT TO EITHER THE PUMP AND/OR THE CATHETER TO BE ANALYZED SINCE THEY FELT THAT THE EXPLANT WAS DUE TO AN INFECTION AT THE LUMBAR REGION, NOT TO EITHER THE PUMP AND/OR THE CATHETER. THE DEVICE AND THE CATHETER WERE REMOVED TO PREVENT SPREAD OF THE INFECTION AND POTENTIAL COMPLICATIONS. THE NEUROSURGEON STATED THAT THERE WAS A SMALL PIECE OF EPIDURAL CATHETER IN THE DURA SPACE FROM THE PREVIOUS INSERTION (8/26/96, SEE MDR#1219454-1996-00438), BUT HE CHOSE TO LEAVE THIS PORTION OF THE EPIDURAL CATHETER IN THE DURA SPACE TO PREVENT THE PT FROM FURTHER EXPOSURE TO INFECTION. THE CATHETER THAT WAS ATTACHED TO THE IMPLANTABLE INFUSION PUMP AND THE INTRATHECAL CATHETER THAT WAS EXPLANTED WERE INTACT AND NO TEARS OR BREAKAGE WERE NOTED. THE PHYSICIANS DO NOT WANT ANY FURTHER FOLLOW-UP PERFORMED REGARDING THIS EVENT.
THE DEVICE WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS; THEREFORE, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR CATALOG NUMBERS 36633 AND 36263, A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD FOR CATALOG NUMBER 36263 DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT. A LOT NUMBER WAS NOT PROVIDED FOR CATALOG NUMBER 36633; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. BASED ON THE INFO AVAILABLE, THE DEVICE WAS EXPLANTED TO PREVENT FURTHER COMPLICATIONS DUE TO THE INFECTION IN THE LUMBAR REGION, NOT DUE TO THE DEVICE OR A DEVICE MALFUNCTION. HOWEVER, THE CAUSE OF THE INFECTION IN THE LUMBAR REGION COULD NOT BE DETERMINED BY THE PHYSICIANS. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
SUTURE BREAKAGE POST-OP REQUIRING RE-OP TO REPAIR SUTURE LINE. UF REPORTS THAT PT EXPERIENCED TWO REOPS FOLLOWING SURGERY (CORONARY BYPASS GRAFT). SURGEON TRADITIONALLY USES 3-0 FOR BOTH THE FIRST & SECOND PURSE STRING LINES HOWEVER, THIS TIME SURGEON CHANGED HIS TECHNIQUE & USED SIZE 4-0 ON SECONDARY PURSE STRING. TWO-THREE HRS FOLLOWING INITIAL SURGERY, SIZE 4-0 BROKE AND REOP WAS DONE TO REPLACE 4-0 WITH SIZE 3-0. EIGHT-TEN HRS LATER, SIZE 4-0 SUTURE FROM INTITAL SURGERY BROKE AT DIFFERENT SITE REQUIRING 2ND RE-OP WHICH WAS ALSO REPAIRED WITH SIZE 3-0 SUTURE. PT IS NOW DOING WELL. CO'S INTERNAL CONTROL NUMBER IS PI 9600514-00.
TEN SAMPLES OF THE MATERIAL IN QUESTION WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND THE RESULTS OBTAINED WERE ABOVE THE CO'S REQUIRMENTS, WHICH WAYS EQUAL OR EXCEED THE MINIMUM USP REQUIRMENTS. DATE DEVICE EXPIRES: 3/31/2001.
ALLEGED INFECTION. FOLLOW-UP FINDINGS: UNSUBSTANTIATED INFECTION AND SEROMA-ETIOLOGY UNKNOWN. OUTCOME-UNDETERMINED.
UNSUBSTANTIATED INFECTION AND UNSUBSTANTIATED SEROMA. THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CO THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE,  NECESSARILY, AN ACCURATE REFLECTION OF CO'S EVALUATION OF THE DEVICE.
THE PT WAS TREATED WITH CATHETER ON 7/30/96 FOR A DISTAL STRICTURE. APPROX 2-3 WEEKS POSTOPERATIVELY PT PRESENTED WITH ABDOMINAL DISCOMFORT. PARENCENTESIS WAS PERFORMED AND REVEALED A COMMON INFECTIVE ORGANISM IN ABDOMINAL FLUID AND THE URINARY TRACT. PT AND FAMILY REFUSED ADD'L EXPLORATORY INTERVENTION. PT EXPIRED DUE TO SEPSIS APPROX 24 DAYS POST OPERATIVE. AUTOPSY REVEALED THE URETERAL INCISION HAD NOT HEALED COMPLETELY WITH APPROX 3MM AREA REMAINING OPEN. AN INCISION WAS ALSO NOTED IN THE PERITONEUM ADHERENT AT DISTAL URETER. PT HAD NO INFECTION PRIOR TO SURGERY AND RECEIVED ANTIBIOTICS FOR ONLY 2-3 DAYS POSTOPERATIVE. NO ADD'L ANTIBIOTIC TREATMENT WAS NOTED DURING POSTOPERATIVE COURSE.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE HEPARIN (25,000U/500ML)AT 24 ML/HR. A NEW CONTAINER WAS STARTED AT APPROX 11 AM, AND AT 1:30PM A NURSE NOTED THAT 400 ML HAD DELIVERED. THE DISPLAY SCREEN INDICATED THE DELIVERY RATE TO BE 200 ML/HR. THE NURSE STATES NO ONE CHANGED THE INFUSION RATE FROM 24 ML/HR TO 200 ML/HR. THE INFUSION WAS STOPPED UNTIL THE PT'S SERUM PTT WAS WITHIN THERAPEUTIC RANGE. THE INCIDENT DID NOT CAUSE ANY ADVERSE EFFECTS TO THE PT.
THE REPORTED PROBLEM COULD NOT BE DUPLICATED DURING TESTING. THE FREQUENCY OF OCCURRENCE OF OVERDELIVERY FOR THE PLUM DEVICE IS APPROXIMATELY .28/MILLION SETS.
THE GUIDE WIRE FROM THE CENTRAL LINE PLACEMENT WAS SURGICALLY REMOVED FROM THE INTERNAL JUGULAR VEIN. X-RAYS WERE TAKEN ON 8/15/96. THE PT'S HISTORY WAS ACUTE INF. MI, S/P TPA. INFO FROM THE USER INDICATES THAT IT WAS A DIFFICULT INSERTION AND THAT THE SPRING WIRE GUIDE HAD MIGRATED TO THE PT'S NECK AREA.
A FILTER MIGRATED INTO THE RIGHT PULMONARY ARTERY AFTER INITIAL PLACEMENT. THE FILTER WAS SURGICALLY REMOVED AT ANOTHER INSTITUTION. CO IS NOT AWARE OF ANY FURTHER ACTION TAKEN AND ATTEMPT TO GAIN FURTHER INFO HAS BEEN UNSUCCESSFUL. THE PT'S CONDITION IS FINE AND PT HAS SINCE BEEN DISCHARGED. THIS PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. CO'S FOLLOW-UP INDICATED A PRE-PLACEMENT VENA CAVOGRAM WAS NOT PERFORMED. IT WAS ALSO REVEALED THAT THE PT EXPERIENCED SIGNIFICANT COUGHING THROUGHOUT THE PROCEDURE. CO BELIEVES THESE FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE.  HOWEVER, WITHOUT EVALUATING THE DEVICE OR FURTHER INFO, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT.
THE CATHETER WAS PLACED ON 8/20 BY AN ANESTHESIOLOGIST. THE FOLLOWING DAY, THE PT WAS POST-OP WITH CATHETER STILL IN PLACE. THE PT FELT SOMETHING WET ON HIS ARM AND THE NURSE NOTED ARTERIAL BLOOD AND UNWRAPPED THE DRESSING. THE CATHETER HAD SEPARATED. A SURGICAL CUTDOWN WAS PEFORMED TO REMOVE THE DISTAL PORTION OF THE CATHETER. THERE WERE NO COMPLICATIONS.
THE IDENTIFIED DEVICE WAS ORIGINALLY IMPLANTED AS AN INVESTIGATIONAL DEVICE UNDER IDE STUDY #G870013 AND WAS NOT AVAILABLE FOR DOMESTIC COMMERCIAL DISTRIBUTION. THE DEVICE WAS REPORTED AS SURGICALLY REVISED AFTER AN IMPLANTATION PERIOD OF (75) MONTHS. THE REVISION SURGERY WAS PERFORMED 3/21/96. REPORTEDLY, RADIOGRAPHS TAKEN APPROX. (14) MONTHS PRIOR TO THE REFERENCED REVISION SURGERY SHOWED EVIDENCE OF OSTEOLYSIS IN THE ACETABULAR CAVITY. AT THE REVISION SURGERY, THE PHYSICIAN REPORTED THE ACETABULAR COMPONENT WAS OBSERVED LOOSE AND OSTEOLYSIS WAS PRESENT IN BOTH THE ACETABULUM AND PROXIMAL FEMORAL AREA. THE ACETABULAR COMPONENT, ITS MODULAR POLYETHYLENE BEARING INSERT AND THE FEMORAL HIP STEM'S MODULAR BEARING HEAD WERE REPLACED WHILE, BONE GRAFTING WAS ALSO PERFORMED.
H6 EVALUATION CODES, METHOD 86 OTHER, (DEVICE MFG. RECORDS REVIEWED) THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE PACKAGE INSERT STATES, IN PERTINENT PART, "LOOSENING OF TOTAL HIP COMPONENTS CAN OCCUR. LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATIONS OR MECHANICAL PROBLEMS, WITH THE SUBSEQUENT POSSIBILITY OF BONE EROSION AND/OR PAIN." THE PACKAGE INSERT CONTINUES BY STATING, "ADVERSE EFFECTS MAY NECESSITATE REOPERATION, REVISION, ARTHRODESIS OF THE INVOLVED JOINT, GIRDLESTONE AND/OR AMPUTATION OF THE LIMB." OSTEONIC DISCLAIMER: SUBMISSION OF INFO BY CO UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THE INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND AN INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFO ACT.
THIS PT IS STATUS POST TIBIAL-VALGUS OSTEOTOMY RT KNEE IN '82. THEN JULY 1994 HE HAD RT TOTAL KNEE ARTHROPLASTY WITH CEMENTED COMPONENTS, EXCISION "BIBARTATE" OSSICLE. NOW OFFICE NOTE OF JULY '96 NOTES THAT PT FEELS BINDING SENSATION IN THE SUPRAPATELLAR REGION. RIGHT KNEE HAS A 1-2+ EFFUSION. X-RAYS NOTED BELOW. PT WENT TO SURGERY 8/12/96 FOR RIGHT KNEE LOOSE PATELLAR COMPONENT AND HAD REVISION OF THE PATELLAR COMPONENT.
ADD'L INFO FROM THE USER FACILITY INDICATES THAT THE DEVICES WERE DISCARDED AFTER THE SURGERY. THE BOX INDICATING THAT THE DEVICES WERE RETURNED WAS CHECKED IN ERROR ON THE MEDWATCH FORM.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS LOADED SLOWLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
SEPARATOR WAS PLACED IN 4/95 BETWEEN TOOTH #2 AND TOOTH #3. ORTHODONTIST SUBSEQUENTLY PLACED A BAND ON TOOTH #2, UNAWARE THAT THE SEPARATOR HAD MIGRATED GINGIVALLY. ORTHODONTIST NOTED IN 12/95 THAT THE PT HAD AN INFECTION BETWEEN TOOTH #2 AND TOOTH #3 AND REFERRED PT TO A DENTIST. PT WAS PLACED ON ANTIBIOTICS FOR INFECTION. PT WAS THEN REFERRED TO AN ENDODONTIST FOR DIAGNOSIS, BUT ENDODONTIST COULD NOT DETERMINE CAUSE OF INFECTION. IN 7/96 PT WAS REFERRED TO A PERIDONTIST FOR EVALUATION. PERIDONTIST FOUND SEPARATOR AND PERFORMED A PERIDONTAL SURGICAL FLAP PROCEDURE TO REMOVE SEPARATOR. ORTHODONTIST STATED THAT PT'S PROGNOSIS IS GOOD.
IS FREQUENCY IS OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? (NO). IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? (UNK). IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? (NO). IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? (UNK).
THE PHYSICIAN WAS USING THE 8C, 8F GUIDING CATHETER TO PERFORM A VENOUS RECANALIZATION IN A PT ON 9/2/96. THE GUIDE WAS ADVANCED THROUGH AN 8F SHEATH INTO THE ILIAC SYSTEM OVER ANOTHER CO'S GUIDEWIRE, WITH THE RETROGRADE APPROACH VIA THE POPLITEAL FOSSA. CLOT WAS ASPIRATED SEVERAL TIMES. THE DETAILS OF THE TECHNIQUE USED WERE NOT PROVIDED IN THE PHYSICIAN'S REPORT. AFTER THE GUIDE WAS EXCHANGED FOR A BALLOON CATHETER, THE GUIDE PLATINUM RADIOPAQUE TIP MARKER BAND WAS NOTED FLUOROSCOPICALLY TO BE DETACHED AND ADJACENT TO THE BALLOON RADIOPAQUE MARKERS, STILL REMAINING UPON THE GUIDE WIRE. THE GUIDE TIP WAS ALSO NOTED TO BE SOFTER. THE "FREE FLOATING" MARKER REMAINED OVER THE GUIDE WIRE WHILE ATTEMPTS TO USE SNARE WERE UNSUCCESSFUL. IT WAS EVENTUALLY BROUGHT FROM THE ILIAC LEVEL INTO THE SUPERFICIAL FEMORAL VEIN AND "PARKED" IN A SIDEBRANCH AT THE INGUINAL FOSSA, AS IT COULD NOT BE PULLED INTO THE SHEATH. IT REMAINS VISIBLE AS A RADIODENSE MARKER. NO PT INJURY OCCURRED.
THIS IS THE SAME PT/EVENT AS MFR#2219689-1996-00074. AS RECEIVED, THE TIBIAL INSERT EXHIBITS MODERATELY HEAVY WEAR ON BOTH CONDYLES WITH A PIECE BROKEN OUT OF THE MEDIAL POSTERIOR REGION. THE WEAR PATTERN SUGGESTS A SLIGHT VARUS MALALIGNMENT. THE PATELLAR COMPONENT IS DISASSOCIATED WITH THE PLASTIC SHOWING HEAVY WEAR AND WEAR-THROUGH INCLUDING A TRANSVERSE CRACK ON THE LATERAL SIDE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH COMPONENTS FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. THE INFO PROVIDED AND THE EXAM RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALIGNMENT.
THE DEVICE WAS APPLIED DURING LAPAROSCOPIC CHOLECYSTECTOMY. REPORTEDLY, THE CLIPS DID NOT LOAD PROPERLY AND THE CLIPS SCISSORED. THE HOSP HAS REPORTED NO PT INJURY. DATE DEVICE EXPIRES: 4/30/2001.
THE PT WAS NOT GAINING RANGE OF MOTION. REVISION SURGERY REVEALED LOOSENING OF THE TIBIAL INSERT IN THE BASEPLATE.
SUMMARY OF EVALUATION: THE TIBIAL WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE INSERT IN THE AS RECEIVED CONDITION WAS THEN ASSEMBLED ONTO THREE BASEPLATES WITH THE RESULTS OF CRISP SNAP ACTION AND FULL, TIGHT SEATING USING ONLY TWO-THUMBS PRESSURE. NO MOVEMENT WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. A QUERY OF THE PRODUCT EXPERIENCE REPORT DATABASE FOUND THAT NO OTHER SIMILAR EVENT HAS BEEN REPORTED FOR THIS LOST OF INSERTS. THE EXAMINATION RESULTS, ALTHOUGH NOT CONCLUSIVE IN THE ABSENCE OF THE EVENT BASEPLATE, SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED.
RECEIVED CORRESPONDENCE INCLUDING A VARIETY OF DOCUMENTS FROM THE BREAST IMPLANT LITIGATION SETTLEMENT WHICH ALLEGED THAT PT HAD RECEIVED BREAST IMPLANTS AND THAT SHE WOULD BE QUALIFIED FOR INCLUSION IN THE DISEASE COMPENSATION PROGRAM WITH THE DIAGNOSIS OF ATYPICAL RHEUMATIC SYNDROME. THE CORRESPONDENCE ALSO CITED THE RUPTURE OF ONE OF THE DEVICES.
AS THE DEVICES WERE NOT RETURNED TO CO, NO PHYSICAL EVALUATION WAS POSSIBLE, AND NO CONCLUSION COULD BE DRAWN. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CO THAT THE REPORT OR INFO THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. REPORTS ARE BASED ON INFO SUPPLIED TO CO WITHOUT INDEPENDENT VERIFICATION AS TO ITS ACCURACY OR COMPLETENESS. IT IS UNDERSTOOD THAT THE INFO MAY NOT REPRESENT FACT AFTER INVESTIGATION.
WHILE EXTRACTING A CHRONIC, VENTRICULAR PACING ELECTRODE OF ANOTHER MFR VIA THE LEFT SUBCLAVIAN, A TEFLON DILATOR INNER SHEATH WAS UTILIZED INSIDE A STAINLESS STEEL DILATOR BECAUSE THE OUTER TEFLON SHEATH OF THE DILATOR SET COULD NOT BE ADVANCED DUE TO FIBRIN WITHIN THE VEIN. WHILE ATTEMPTING ADVANCEMENT OF THIS METAL OVER TEFLON DILATOR COMBINATION, A NARROW, EIGHT CENTIMETER LONG SLIVER WAS SLICED LONGITUDINALLY FROM THE TEFLON SHEATH. THE PACING ELECTRODE WAS THEN EXTRACTED USING THE FEMORAL ROUTE. THE INSULATION OF THE ELECTRODE WAS FOUND TO BE BROKEN WITH RESULTANT EXPOSURE AND DISTENSION OF THE METAL CONDUCTOR HELIX. THE PORTION OF THE TEFLON SHEATH WAS THEN SURGICALLY REMOVED FROM THE SUBCLAVIAN. THE CHEST TUBE WAS INSERTED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE CLIPS INSTRUMENT SLEEVE DISENGAGED FROM THE OBTURATOR. THE HOSP HAS REPORTED NO PT INJURY.
ALTERATION IN VENTILATOR RATE SETTING. NO EVIDENCE RATE CHANGES DONE MANUALLY. PT HAND VENTILATED UNTIL NEW VENTILATOR ACQUIRED. INFANT S/P B.T. SHUNT, COMPLEX CONGENITAL HEART.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERRIORRAPHY PROCEDURE. REPORTEDLY, THE PORT LEAKED PNEUMOPERITONEUM. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
12/04/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D7 AND D8. CORRECTED DATA ENTERED IN B4, F8 AND D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
TWO HANDPIECES WERE RETURNED WITH INFO THAT ONE HANDPIECE BECAME WARM TO THE TOUCH BY THE END OF A CATARACT EXTRACTION PROCEDURE. BOTH HANDPIECES WERE REPLACED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. NOTE: THIS EVALUATION RELATED TO S/N 13370. SEE 1920664-1996-000619 FOR THE EVALUATION OF S/N 14370. THIS HANDPIECE APPEARS TO HAVE BEEN REWORKED BY AN OUTSIDE VENDOR. THE CABLE IS A HEAVIER GAUGE, THE STRAIN RELIEF IS DIFFERENT AND SOME TYPE OF ABRASIVE HAS BEEN USED ON THE BODY. ADDITIONALLY,THE RING IS STRETCHED.
CAST CUTTER TURNED ON. SOUND DECREASED. CUTTER SHUT OFF. 2 WASHERS MISSING FROM THE TOP. POSSIBLE SCREW MISSING WITH BLADE IN PLACE. MACHINE CHECKED BY BIOMED 4/21/96.
PENCIL TURNS ON WHEN BUTTONS ARE NOT PUSHED.
THE DEVICE WAS DURING A LAP HERNIA REPAIR PROCEDURE. REPORTEDLY, THE PORT LEAKED PNEUMOPERITONEUM. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. DATE DEVICE EXPIRES: 3/31/2001.
PHYSICIAN DESCRIBED EXPLANTED DEVICE AS HAVING A "MECHANICAL DEFECT."
THE DEVICE WAS USED DURING A LAP CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE PORT LEAKED PNEUMOPERITONEUM. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PT WAS BURNED WHEN FACILITY USED A WARMING UNIT WITHOUT A WARMING BLANKET. INJURY WITHOUT A WARMING BLANKET. INJURY PROGRESSED TO MUSCLE NECROSIS NECESSITATING AMPUTATION. FACILITY REPORT ATTACHED AS PAGES 3 AND 4 OF THIS REPORT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE PNEUMOPERITONEUM LEAKED FROM THE PORT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
TWO HANDPIECES WERE RETURNED WITH INFO THAT ONE HANDPICE BECAME WARM TO THE TOUCH BY THE END OF A CATARACT EXTRACTION PROCEDURE AND WAS PULLED FROM SERVICE; THE OTHER HANDPIECE WOULD NOT CALIBRATE AT THE BEGINNING OF A CATARACT EXTRACTION PROCEDURE. BOTH HANDPIECES WERE REPLACED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. NOTE: THIS EVALUATION RELATES TO S/N 14360. SEE 1920664-1996-00618 FOR THE EVALUATION OF S/N 13370. THIS HANDPIECE WAS DEFORMED AT THE TAIL, PHYSICALLY DAMAGED AND MARRED.
DURING SURGICAL REPAIR OF A JUXTARENAL ABDOMINAL AORTIC ANEURYSM, THE HOSE OF THE BLANKET WAS PLACED UNDER THE PT'S CLOTH BLANKET, WITHOUT USING THE BLANKET. A BURN WAS NOTED ON THE PT'S LOWER LEG. THE INJURY PROGRESSED TO MUSCLE NECROSIS NECESSITATING ABOVE THE KNEE AMPUTATION.
THE DEVICE WAS USED INAPPROPRIATELY. PT CONDITION CONTRAINDICATED USAGE. SURGICAL PROCEDURE CONTRAINDCATED USAGE. DEVICE LABELING, IFU AND OPERATION MANUAL SPECIFICALLY WARN AGAINST: USING THE WARMING UNIT WITHOUT A BLANKET, USING THE SYSTEM ON POORLY PERFUSED SKIN, USING THE DEVICE DURING AORTIC CROSS CLAMPING.
THE DEVICE WAS APPLIED DURING AND UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE VISIBILITY WAS NOT CLEAR. THE HOSP HAS REPORTED NO PT INJURY.
BED WITH BRAKE MALFUNCTION. DEFLATED DURING PULMONARY ARTERY CATHETER INSERTION. ATTEMPTS TO REINFLATE WERE UNSUCCESSFUL. BED MAKING A CLICKING NOISE. MEMORY RETURN NOT WORKING. THREE SCREWS NOTICED UNDER BED WITH ONE ROUND, 2 INCH LONG BAR. PT MOVED TO A DIFFERENT BED AND PROCEDURE RESUMED. THREE ICU RNS UNABLE TO RESOLVE INFLATION PROBLEM WITH BED. REPORTED IMMEDIATELY TO DISTRIBUTOR.
A PHLEBOTOMIST WAS GOING TO DISPOSE OF A NEEDLE/SYRINGE; AS SHE TRIED TO OPEN THE DOOR, REPORTEDLY A NEEDLE/SYRINGE CAME OUT AND SOMEHOW SHE RECEIVED A NEEDLESTICK.
DEVICE DISCARDED. REPORTER DECLINED ON-SITE VISIT. LOT CODE SPECIFIC INFO NOT AVAILABLE. REPORTED EVENT NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN USUAL FOR THIS PRODUCT.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE VISIBILITY WAS NOT CLEAR. THE HOSP HAS REPORTED NO PT INJURY.
DURING A RECENT LITERATURE REVIEW, A EVENT WAS FOUND IN A LETTER TO THE EDITOR IN ANESTHESIOLOGY, VOLUME 85, 8/96. (A COPY OF THE LETTER AND THE REPLIES ARE ATTACHED.) THE LETTER DESCRIBES A CASE WITH A MASK THAT WAS IMPROPERLY CLEANED. THE IMPROPERLY CLEANED MASK CAUSED A PT TO EXPERIENCE PERILARYNGEAL EDEMA. EMERGENT CONVENTIONAL LARYNGOSCOPIC INTUBATION WAS REQUIRED. THE PT SUFFERED NO LONG-TERM EFFECTS AND THE INSTITUTION CORRECTED ITS CLEANING PROCEDURES.
THIS REPORT IS SUBMITTED ON BEHALF OF THE DEVICE MFR. CO ESSENTIALLY DUPLICATES INFO ALREADY FORWARDED TO FDA BY THE DISTRIBUTOR. PLEASE NOTE THAT THE MFR IS USING THE DISTRIBUTOR'S REPORTING NUMBER FOR ID PURPOSES UNTIL THE MFR IS ISSUED ITS OWN REPORTING NUMBER.
NASAL SURGERY DONE IN 4/94. ENT SURGEON USED X-RAY FILM AS NASAL SPLINTS FOLLOWING SURGERY WHICH WERE NOT REMOVED UNTIL ONE WEEK AFTER SURGERY. SURGEON SAYS THIS IS A USUAL PROCEDURE BUT RPTR HAS COMPLETE LOSS OF SMELL.
AFTER ADMINISTERING A S.Q. INJECTION, PUT NEEDLE INTO THE DISPOSAL AND IT PRICKED THE INDEX FINGER ON MY RIGHT HAND. REPORTEDLY "FLIPPED" IN TRAY OF THE SHARPS BOX.
METAL FLAKES CAME FROM THIS HANDPIECE DURING A CATARACT EXTRACTION PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE INITIAL REPORTER FOR ADD'L INFO WITHOUT SUCCESS. ADDITIONALLY, THE HANDPIECE PASSED THE FILTER TEST.
BLUE CLAMP WHICH IS USED TO CLAMP OFF TUBING FREQUENTLY BREAKS.
THE DR CLAIMS THAT THE GRAFT, WHICH WAS IMPLANTED FOR AN AORTO-BIFEMORAL BYPASS GRAFT, LEAKED APPROX. 200CC OF BLOOD THROUGH ITS WALLS WHEN THE CLAMP WAS RELEASED. THE DR CONTROLLED THE LEAK BY CLOSING AND OPENING THE CLAMP UNTIL THE BLEEDING SLOWED ENOUGH TO LEAVE THE GRAFT IN THE PT. THE PT'S CONDITION IS OK.
CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL - NO SIMILAR COMPLAINTS AGAINST THIS BATCH. GROSS DESCRIPTION: RECEIVED IN FORMALIN IS A SEGMENT OF CRIMPED DACRON VASCULAR GRAFT WITH NO BLOOD OR TISSUE ATTACHED. THE SPECIMEN MEASURES 5.2 CM IN LENGTH BY 2.0 CM IN OUTER DIAMETER. REP. SECTIONS ARE EMBEDDED UNDER MD-917 AND MD-918. MICROSCOPIC DESCRIPTION: SEGMENTS OF AN INTACT DACRON VASCULAR GRAFT WITH AN INTACT COLLAGEN COATING ARE IDENTIFIED. THE COLLAGEN COATING IS PRESENT ON THE LUMINAL SURFACE, PERIADVENTITIAL SURFACE, AND WITHIN THE INTERSTICES OF THE DACRON FABRIC. NO EVIDENCE OF IMPLANTATION IS IDENTIFIED. SUMMARY: AN INTACT DACRON VASCULAR GRAFT WITH AN INTACT COLLAGEN COATING IS IDENTIFIED. NO EVIDENCE OF IMPLANTATION IS IDENTIFIED.
THE PT UNDERWENT A POLYP REMOVAL PROCEDURE WITHOUT COMPLICATIONS. THE NEXT DAY THE PT RETURNED TO THE OR FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL AND GASTRIC BIOPSIES. THE PT TOLERATED BOTH PROCEDURES WELL AND WAS DISCHARGED. TWO HRS AFTER DISCHARGE, ABDOMINAL PAIN WAS EXPERIENCED. PT WAS TRANSFERRED TO OR WHERE EXPLORATORY LAPAROTOMY REVEALED TWO PERFORATIONS IN THE CECUM, COMPATIBLE WITH CAUTERY BURNS. THE BIOMEDICAL ENGINEERING DEPT EXAMINED THE EQUPIMENT AND INDICATED THAT "NO DEVIATION FROM STANDARD PRACTICE OF CARE OR DEFECT WITH THE EQUIPMENT" WERE REVEALED. THE PT UNDERWENT CECAL RESECTION AND APPENDECTOMY.
PHYSICIAN REPORTS THAT THE DIAPHRAGM OF THE CATHETER DID NOT FUNCTION. FLUID SEEPED OUT OF THE CATHETER AND GAS COULD BE HEARD. PHISICIAN PLACED FINGER OVER TO PREVENT AIR FROM ENTERING THE CATHETER. BALL VALVE FAILED TO CLOSE OFF CATHETER AFTER STYLET (NEEDLE) WAS REMOVED.
INVESTIGATION IS IN PROGRESS. PRELIMINARY TEST RESULTS INDICATE THE PRODUCT IS FUNCTIONING PROPERL;Y. THE UNITS HAVE BEEN RETURNED TO THE PLANT OF MFR FOR EVALUATION. LOT HISTORY CHECK AND COMENT. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE. THIS REPORT DOES NOT NECESSARILY REFLRECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
MORPHINE IMPLANTABLE INFUSION PUMP EXPLANTED. PER PT DEVICE "NEVER WORKED PROPERLY," I.E., FOR ITS INTENDED USE OF PAIN CONTROL. DEVICE WAS EXPLANTED BECAUSE PT CLAIMED "IT NEVER WORKED". SPOKE WITH REPORTER, DEVICE IS IMPLANTABLE CATHETER.
SECTIONS A THROUGH F WERE COMPLETED BY MFR. DATE ENTERED IN SECTION F.13 IS DATE DESCRIPTION OF FAILURE WAS RECEIVED. SEVERAL ATTEMPTS WERE MADE TO CONTACT INITIAL REPORTER FOR ADDITIONAL INFO WITHOUT SUCCESS. ADDITIONALLY, HANDPIECE PASSED FILTER TEST.
ACTIVE CORD SPARKED AND MELTED IN HALF DURING COAGULATION OF LAP CHOLE PROCEDURE. NO INJURY TO PT.
TEH DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CAUTERY BURNED THROUGH THE TIP OF THE INSTRUMENT AND A PIECE FELL INTO THE PT'S CAVITY. THE SURGEON RETRIEVED THE DISENGAGED PIECE WITH A HAND INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
RPTR LOST HER JOB AS AN RN, DUE TO AIRBORNE REACTIONS TO LATEX GLOVES AND ALL LATEX MEDICAL SUPPLIES IN THE HOSP.
THE CUSTOMER REPORTED THAT THE HOSP BIOMED ENGINEERING DEPT EXAMINED THE EQUIPMENT AND NO DEFECT WITH THE EQUIP WAS REVEALED. THE EQUIPMENT IS REPORTEDLY BACK IN USE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS GENERATOR INDICATES NO INFO RELATED TO THIS REPORTED EVENT.
THE PRODUCT WAS USED DURING A CABG PROCEDURE INVOLVING INVOLVING ONE PT. REPORTEDLY, THE SUTURE BROKE. THE SURGEON APPLIED ADDITIONAL SUTURE TO COMPLETE THE PROCEDURE. THE HOSP REPORTED NO PT INJURY.
THE PRODUCT HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THE SURGEON LOADED THE FIRST CLIP WHICH FELL OUT OF THE JAWS. SUBSEQUENT LOADINGS RESULTED IN POORLY FORMED CLIPS THAT FELL OUT OF THE JAWS. THE INSTRUMENT WAS NOT INTRODUCED INTO THE BODY, A SECOND DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: YIELDED JAWS. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKINT THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
THE BLISTER PACKAGE OF THE FEMORAL STEM COMPONENT WAS BROKEN. THIS EVENT WAS NOTICED PRIOR TO A SURGICAL PROCEDURE.
H4: THE MFR DATE IS 6/94. EVALUATION: A VISUAL INSPECTION OF THE RETURNED PRODUCT VERIFIED THAT THE INNER BLISTER EXHIBITED A LARGE CRACK TOWARDS THE PROXIMAL END OF THE IMPLANT. THE DEVICE WAS MOST LIKELY DROPPED OR SUBJECTED TO EXCESSIVE EXTERNAL FORCES CAUSING THE BLISTER TO CRACK. THE PACKAGE NOW HAS FOAM INSERTS AS AN ADDED MEASURE AGAINST SUBJECTED TO EXCESSIVE EXTERNAL FORCES.
TWO FILTERS CONTAINED A STRAND OF HAIR IN EACH OF THE PACKAGES. THE UNITS ARE STERILIZED BEFORE PACKAGING. THE RPTR FELT THERE WAS A QUALITY ASSURANCE ISSUE.
RESEARCH ASSISTANT NOTICED NUBMERS DID NOT SEEM CORRECT. IMMEDIATELY STOPPED THE INFUSION AND CHANGED THE PUMP. PT WAS RECEIVING A PLACEBO AT THE TIME.
HANDPIECE COULD NOT BE CALIBRATED DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER HANDPIECE WAS USED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. RESULTS OF THE VISUAL EVALUATION INDICATED THAT THE ASPIRATION TUBE WAS BENT.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. REPORTEDLY, THE TIP OF THE JAWS WAS BROKEN. THE HOSP HAS REPORTED NO PT INJURY.
RESIDENT WAS BEING TRANSFERRED WITH 2 NSG ASSISTANTS ASSISTING WITH A LIFT. WHEN RESIDENT WAS RAISED ON LIFT, THE LIFT SLING STRAP BROKE CAUSING RESIDENT TO FALL TO THE FLOOR. THE RESIDENT WAS NOT INJURED. THE STRAP DID NOT SHOW ANY FRAYING OR WEAR PRIOR TO TRANSFER. THE BREAK IN THE STRAP OCCURRED IN THE MIDDLE OF THE STRAP, NOT AT ANY SEAM.
HEALTHCARE PROFESSIONAL WAS DIAGNOSED WITH OCCUPATIONAL ASTHMA AND HYPER-REACTIVE AIRWAYS DUE TO GLUTARALDEHYDE SENSITIVITY.
THE LABELING FOR THE SUSPECT MEDICAL DEVICE WARNED AGAINST INHALATION.
INVESTIGATION CONDUCTED. DOCTOR CITES INSUFFICIENT BONE QUANTITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE WAS USED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT MISFIRED. THE HOSP COULD NOT PROVIDE ANY ADD'L INFO. HOWEVER, THE HOSP STATED THAT NO PT INJURY OCCURRED.
INVESTIGATION CONDUCTED. DR.UNSURE OF CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE WAS APPLIED DURING BOWEL SURGERY. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. THE SURGEON USED ANOTHER STAPLER.
9/24/96-CORRECTED INFORMATION SUBMITTED FOR B-3, B-4, F-6 AND F-8. ADDITIONAL INFORMATION SUBMITTED FOR D-9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H-3 AND H-6.
INVESTIGATION CONDUCTED. DOCTOR CITES ABSCESS, BONE QUANTITY INSUFFICIENT AND POST SURGICAL LOADING OF IMPLANT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE WAS APPLIED DURING OPEN BOWEL RESECTION SURGERY. REPORTEDLY, A PLASTIC COMPONENT DISENGAGED FROM THE DEVICE AND FELL INTO THE PT'S CAVITY. THE COMPONENT WAS READILY RETRIEVED. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING A LOBECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON OPENED THE JAWS BY MANUAL MANIPULATION AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE, INVOLVING ONE PT. REPORTEDLY, THE CLIPS WERE SCISSORING. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED NO PT INJURY. DATE DEVICE EXPIRES: 4/30/2001.
INVESTIGATION CONDUCTED. DOCTOR CITES BONE QUALITY INSUFFICIENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, INVOLVING ONE PT. REPORTEDLY, CLIPS EJECTED PREMATURELY. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSP HAS REPORTED NO PT INJURY.
DURING A FLAP GRAFT FOLLOWING A LARYNGECTOMY PROCEDURE, THE SUTURE BROKE. THE SURGEON SWITCHED TO A LARGER SUTURE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
IN THE EMEREGENCY ROOM, A DISPOSABLE LARYNGOSCOPE BLADE (SIZE UNREPORTED)BROKE, NEAR THE CONTACT AREA, DURING AN INTUBATION ATTEMPT ON A 65 YEAR OLD FEMALE, WEIGHING APPROX 80 KILOS. THE PT WAS UNCONSCIOUS AND IN CARDIAC ARREST. ON A SECOND ATTEMPT, (TYPE OF BLADE USED IS UNKNOWN) THE PT WAS SUCCESSFULLY INTUBATED AND WAS STABILIZED. THE ATTENDING PHYSICIAN, STATED "INTUBATIONS ARE DIFFICULT AND TOO MUCH PRESSURE (FORCE) MAY HAVE BEEN USED". THE BLADE WAS NOT SAVED FOR EVALUATION.
THE MOST LIKELY CAUSE OF THE BLADE BREAKING IS THAT TOO MUCH FORCE WAS APPLIED WHEN ATTEMPTING TO INTUBATE. BLADE STRENGTH IS TESTED AT RECEIVING INSPECTION TO A SPEC OF 34 POUNDS MINIMUM, WITHOUT THE BLADE BREAKING. THIS SPEC OF 34 POUNDS MINIMUM STRENGTH WITHOUT BREAKING INCLUDES A +100% SAFETY FACTOR. STUDIES SHOW THAT PTS NECESSITATING COMPLICATED INTUBATIONS REQUIRED 38% HIGHER AVERAGE FORCE. IT IS EXPLICITLY STATED IN CO'S PRODUCT INSER (INS-BLADES/REV.C) UNDER "WARNING: DO NOT USE CO'S DISPOSABLE BLADES IN DIFFICULT INTUBATIONS WHERE EXCESSIVE FORCE IS REQUIRED. IN THESE SITUATIONS REUSABLE METAL BLADES ARE INDICATED. BOTH BLADES SHOULD BE AVAILABLE TO THE USER. DISPOSABLE LARYNGOSCOPE BLADES ARE NOT SUITABLE FOR UNUSUAL LARYNGEAL ANATOMIES RELATED TO PT SIZE OR ABNORMALITIES. NEVER USE EXCESSIVE FORCE DURING THE INTUBATION. EXCESSIVE FORCE MAY RESULT IN TRAUMA TO THE AIRWAY, BLEEDING, BROKEN TEETH AND FAILURE IN PLACEMENT OF THE ENDOTRACHEAL TUBE. FLEXING OF DISPOSABLE BLADES INDICATES EXCESSIVE FORCE. IF THE DISPOSABLE BLADE FLEXES AND THERE IS DIFFICULTY IN EXPOSING THE GLOTTICAL OPENING AND VOCAL CORDS, THE USE OF A REUSABLE METAL BLADE IN INDICATED. DISPOSABLE PLASTIC LARYNGOSCOPE BLADE SIZES MAY DIFFER FROM REUSABLE BLADES OR FROM OTHER MFR'S BLADES. CONFIRM APPROPRIATE SIZE BEFORE USE." CO HAS NO INFO TO SUGGEST THAT THE REPORTED EVENT IS OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAT IS USUAL FOR THE DEVICE.
DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, INVOLVING ONE PT. REPORTEDLY, THE STAPLES DID NOT LOCK. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
ANESTHETIST ACCIDENTLY OPENED THE FILLER VALVE ON ANESTHESIA VAPORIZER DURING A SURGICAL PROCEDURE SPILLING ENFLURANE ONTO THE TABLE TOP OF THE ANESTHESIA MACHINE. CONDITION WAS IDENTIFIED BY THE ODOR OF THE ANESTHETIC AGENT AND PRESENCE OF LIQUID AGENT ON THE MACHINE. THE FILLER VALVE WAS CLOSED AND LIQUID AGENT WAS SUCTIONED AWAY. CONCENTRATION OF ENFLURANE VAPOR AT THE HEAD OF THE OPERATING TABLE WAS, HOWEVER, SUFFICIENT TO OVERCOME THE CRNA AND HE LOST CONSCIOUSNESS. A SECOND CRNA RELIEVED THE FIRST. THE CASE WAS CONCLUDED WITHOUT FURTHER INCIDENT AND NEITHER THE CRNA NOR PT HAD AN ADVERSE OUTCOME. IN REVIEWING THE INCIDENT IT WAS DETERMINED THAT THE FILLER VALVE ON THIS TYPE VAPORIZER COULD BE OPENED UNINTENTIONALLY DURING ROUTINE ANESTHESIA PROCEDURES. THE MFR STATES "TO DATE, IN EXCESS OF 55,000 VAPORIZERS HAVE BEEN DISTRIBUTED WORLDWIDE, WITH MINIMAL SIMILAR REPORTS." THE MACHINE WAS EXAMINED FOR MALFUNCTION AND NONE WAS FOUND. (*)
A NUMBER OF INSULIN SYRINGE NEEDLES WERE VISABLY CONTAMINATED WITH A BROWN SUBSTANCE.
THE PAST 6 MONTHS THERE HAS BEEN AN EXTREMELY NOTICABLE CHANGE IN THE DEGREE OF SHARPNESS OF ALLERGY FILTER NEEDLES. THIS RANGE WAS FROM SMOOTH TO SHARP TO VERY PAINFULLY DULL.
PT MONITOR FREQUENTLY ALARMING "LEADS FAIL", SHOWS ARTIFACT DESPITE RE-WETTING AND REPOSITIONING. POOR TRACING OR BAD CONDUCTION AND DO NOT STICK WELL TO INFANTS. LEAD WIRES HAD TO BE REPLACED MUCH MORE OFTEN.
KNEE PROSTHESIS REMOVED DUE TO POSSIBLE DEFECT.
PROBLEM WITH BALLOON CATHETER INSERTION, BALLOON CATHETER "ACCORDIONED" AT TIME OF INSERTION DURING ANGIOPLASTY OF BASILIC VEIN. BALLOON WAS PROMPTLY REMOVED WITH NO ILL EFFECT TO PT.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SAFETY SHIELD WOULD NOT RELEASE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, DIFFICULTY WAS EXPERIENCED IN CLOSING AND FIRING THE DEVICE. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY. DATE DEVICE EXPIRES: 5/31/2001.
10/10/96- SUPPLEMENTAL REPORT SUBMITTED TO FDA BY MFR.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE INSTRUMENT DID NOT OPEN AND CLOSE PROPERLY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SLEEVE WAS DAMAGED DURING USE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. REPORTEDLY, THE PNEUMOPERITONEUM WAS LEAKING THROUGH THE BODY HOUSING. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING A WEDGE RESECTION PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY. DATE DEVICE EXPIRES: 9/30/2000.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE CARTRIDGE BROKE. THE HOSP HAS REPORTED NO PT INJURY. DATE DEVICE EXPIRES: 6/30/2001.
DEVICE DISPLAYED INSUFFICIENT CLEARANCE BETWEEN THE LATCH SPRING AND THE SAFETY SHIELD ASSEMBLY. THIS CONDITIONS PREVENTED THE SAFETY SHIELD FROM RELEASING TO EXPOSE THE TROCAR FOR PENETRATION. BECAUSE THE SURGEON COULD NOT ACHIEVE PENETRATION WITH THIS DEVICE, A SECOND DEVICE WAS USED. THIS CONDITION HAS BEEN ADDRESSED IN CURRENT PRODUCTION.
AFTER PRIMING IV TUBING FOR PUMP, NURSE NOTICED WHAT APPEARS TO BE SMALL PIECES OF WHITE PLASTIC FLOATING IN TUBING. TWO DIFFERENT SETS OF TUBING HAVE BEEN IDENTIFIED AS HAVING THE PIECES OF PLASTIC FLOATING. ONE SET HAS PLASTIC IN CHAMBER AS WELL AS TUBING. BOTH WERE CAUGHT PRIOR TO USING PTS.
INVESTIGATION CONDUCTED. DOCTOR UNSURE OF CAUSE FOR FAILURE. PT IS A SMOKER AND WAS HAVING PAIN AFTER HEALING SCREW WAS PLACED. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
ONE UNIT WAS SENT TO CO FOR EVALUATION. EVALUATION OF THE RETURNED UNIT SHOWED A LARGE WHITE PIECE OF PLASTIC INSIDE THE TUBING. THE PLASTIC IS A PIECE OF THE GATE FROM THE MOLDING PROCESS. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED PROCEDURES TO REDUCE LOOSE PARTICULATE MATTER FROM THE MOLDING PROCESS. RETAINED SAMPLES FROM LOT 26D 191197 WERE EVALUATED AND WERE FOUND TO BE ACCEPTABLE. THE LOT HISTORIES WERE REVIEWED AND WERE FOUND TO BE ACCEPTABLE. INCORRECT ASSEMBLY OF THE CASSETTE COULD NOT BE VERIFIED.
PARAMEDICS RESPONDED TO A PERSON FOUND UNRESPONSIVE, DESCRIBED AS IN FULL CARDIAC ARREST. THE PT WAS CONNECTED TO A DEFIBRILLATOR/MONITOR/PACEMAKER WITH THE ELECTRODES, DIAGNOSED AS IN ASYSTOLE AND EXTERNAL PACING INITIATED. ACCORDING TO THE REPORTER, THE PACEMAKER WOULD NOT PACE THE PT. THE BASIS FOR THIS OPINION WAS NOT REPORTED. THE PT WAS TRANSPORTED AND, UPON ARRIVAL AT THE HOSP'S EMERGENCY DEPARTMENT, A BACKUP DEFIBRILLATOR/MONITOR/PACEMAKER WAS USED WITH THE SAME ELECTRODES. THE REPORTER STATED THAT THE BACKUP PACEMAKER ALSO WOULD NOT PACE THE PT BUT AGAIN DID NOT REPORT THE BASIS FOR THIS OPINION. THE ELECTRODES WERE REPLACED WITH ANOTHER SET OF THE SAME TYPE AND, ACCORDING TO THE REPORTER, THE PACEMAKER WAS THEN ABLE TO PACE THE PT. THE PT WAS NOT RESUSCITATED. THE REPORTER INDICATED THE REPORTED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PT. THE REPORTER BASED THEIR OPINION ON THE ATTENDING PARAMEDIC'S ASSESSMENT THAT THE PT HAD BEEN "DOWN A LONG TIME."
THE ELECTRODES WERE REPLACED BUT THE REPLACED ELECTRODES WERE DISPOSED OF BY THE FACILITY AND NOT AVAILABLE FOR EVALUATION. F10: PT CODE #1762-LABELED. DEVICE CODE #1439-LABELED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE CLIPS DID NOT LOAD PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY. DATE DEVICE EXPIRES: 4/30/2001.
INVESTIGATION CONDUCTED. DOCTOR UNSURE OF CAUSE FOR FAILURE. POSSIBLE AUGMENTATION MATERIALS AS CAUSE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE WAS APPLIED DURING A BIFEMORAL BYPASS ON THE AORTA. REPORTEDLY, THE INCISION EVISCERATED APPROX. ONE WEEK POST-OPERATIVELY. THE SURGEON REOPERATED TO RE-APPLY SUTURE. THE HOSP HAS REPORTED THE PT IS IN SATISFACTORY CONDITION.
INVESTIGATIONCONDUCTED. DOCTOR CITES BONE AND TISSUE RESORPTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
THE DEVICE WAS USED DURING AN OFFICE DEMONSTRATION. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. TEH CLIPS DID NOT FORM PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNKNOWN. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS FROM BOX D6. MODEL #2210. CATALOG #2210. LOT NUMBER 950329.
THE NOZZLE SEPARATED FROM THE BARREL WHILE INJECTING CEMENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVAL: THE ROOT CAUSE OF THE FIELD COMPLAINT IS ATTRIBUTED TO A LESS THAN OPTIMUM WELD OF THE EXTENDER TUBE AND SYRINGE BODY. CORRECTIVE ACTIONS WAS IMPLEMENTED TO PRECLUDE THIS CONDITION.
THE DEVICE WAS PLACED IN A 70-80 YEAR OLD MALE WITH CVA. THE PROCEDURE PROGRESSED NORMALLY. NO UNUSUAL ANATOMY WAS NOTED DURING THE ENDOSCOPY. UPON RESCOPING THE PT TO CONFIRM PLACEMENT, THE INTERNAL BUMPER WAS NOTED TO BE INVERTED. IT HAD APPARENTLY INVERTED DURING PASSAGE THROUGH THE ESOPHAGUS. THE PHYSICIAN ATTEMPTED TO REVERT THE BUMPER TO ITS ORIGINAL SHAPE, BUT WAS UNSUCCESSFUL. THE PHYSCIAN STATED THE TUBE WAS SECURE AND DID NOT NEED TO BE REPLACED AT THAT TIME. THE PHYSICIAN PLANS TO REMOVE THE TUBE AT 6 WEEKS AND REPLACE IT WITH A BALLOON CATHETER. THE PT SUFFERED NO ILL EFFECTS. NOTE: THE EVENT DATE GIVEN ABOVE IS APPROXIMATE.
SAMPLE WAS VISUALLY INSPECTED AND SOME DISCALMATION WA SFOUND ON THE BUMPER (BROWN). THE BUMPER AND PART OF THE TUBE WERE CUT AWAY FROM THE REST OF THE SAMPLE. NO OTHER DEFECTS WERE FOUND. BUMPER WAS INVENTED. MAGNA PORT 4-CONNECTOR WAS INSERTED INTO THE TUBE ALSO. BUMPER AND TUBE HAD BEEN USED FOR A WHILE. DICOLORATION ON ON BUMPER AND PRODUCT BUILD UP ON Y-PORT AND TUBE. NO WAY TO TELL WHEN INEROSION TOOK PLACE. IF INVETER  DURING PUROMENT IT WAS USED THAT WAY FOR SOME TIME.
THE DEVICE WAS USED DURING A LOBECTOMY PROCEDURE. REPORTEDLY, THE JAWS OF THE INSTRUMENT WERE DIFFICULT TO CLOSE OUTSIDE OF THE PT'S CAVITY. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/28/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA BY MFG. ADDITIONAL DATA ENTERED IN D4, D8 AND D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA SUBMITTED FOR B4 AND F8.
THE CEMENT LEAKED FROM THE SYRINGE. THIS EVENT DID NOT CAUSE ANY ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
THE TIME TO EXTRUDE THE CEMENT EXCEEDED THE RECOMMENDED TIME ALLOWED (2.5 MINUTES TO 3.5 MINUTES) FOR LOW VISCOSITY EXTRUSION THROUGH A POWER PAK SYRINGE NOZZLE, THE CEMENT MUST BE MIXED WITHIN 2.5 MINUTES AND PLACED IN A CEMENT GUN FOR IMMEDIATE EXTRUSION. F1-14: HAS BEEN FILED OUT BY THE MFR. INFORMATION HAS BEEN RECEIVED FROM A FOREIGN AFFILIATE. ADDITIONAL INFORMATION IS UNOBTAINABLE.
DURING A DIALYSIS TREATMENT, THERE WAS WEIGHT GAIN OF APPROX .25 KG. PT UNDERWENT AN UNSCHEDULED TREATMENT TO REMOVE THE WEIGHT. FOUND TO BE FAILED UF (ULTRAFILTRATION) PUMP.
DURING A DIALYSIS TREATMENT, THERE WAS 1/4 KG. WEIGHT GAIN REPORTED. THE PT REPORTEDLY UNDERWENT A SECOND, UNSCHEDULED TREATMENT TO REMOVE THE WEIGHT. A TECHNICIAN AT THE FACILITY EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE TECHNICIAN AT THE FACILITY FOUND THE UF PUMP THERMAL FUSE TO BE OPENED (FAILED). THE FUSE HAS NOT BEEN RECEIVED FOR INVESTIGATION AS OF THE TIME OF THIS REPORT. THE THERMAL FUSE WOULD BE RETURNED TO THE MFR FOR INVESTIGATION IF THEY FOUND IT. NO THERMAL FUSE WAS RETURNED FOR INVESTIGATION. WITHOUT THE THERMAL FUSE A THOROUGH INVESTIGATION CANNOT TAKE PLACE. IT HAS BEEN SEEN PREVIOUSLY THAT THE WAX IN THE THERMAL FUSE MELTS, CAUSING THE FUSE TO OPEN (FAIL). THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT.IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. CUSTOMER CONTACTED:Y. SALES/SERVICE CONTACTED BY INVESTIGATOR:N. TRAINING REQUIRED:N.
THE CATHETER INTRODUCER HUB BROKE DURING DEPLOYMENT. A TECHNICIAN ASSISTED THE DOCTOR BY HOLDING THE DELIVERY SYSTEM ON TO THE INTRODUCER. THE FILTER WAS DEPLOYED IN THE TARGET LOCATION.
HUB BROKE ON THE INTRODUCER CATHETER DURING FILTER DEPLOYMENT. A TECHNICIAN ASSISTED THE MD BY HOLDING THE DELIVERY SYSTEM ONTO THE INTRODUCER. THE FILTER WAS PLACED AT THE TARGETED LOCATION WITH NO PT INJURY OR COMPLICATIONS REPORTED. BOTH DILATOR HUB AND INTRODUCER SHEATH HUB WERE BROKEN OFF. A NON-CO MALE LUER WAS USED. THIS MALE LUER HAS A LONGER AND LARGER TIP THAN THE MALE LUER OF THE CO'S STORAGE TUBE. THE CO'S STORAGE TUBE MALE LUER IS CUSTOM. THE INSTRUCTIONS FOR USE STATES: "NOTE: THE INTRODUCER HUB HAS A SPECIAL INTERNAL DESIGN. CARE SHOULD BE TAKEN TO MAKE CONNECTIONS FIRMLY, BUT WITHOUT EXCESSIVE FORCE THAT MAY CAUSE BREAKAGE TO BE HUB." LR LOT# 52955-3 (ANOTHER CO'S LOT# 4UBC70), RECEIVED ON 10/14/94 AND 52955-4 (ANOTHER LOT# 4WBC88) AND RECEIVED 11/15/94. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 02-065713 CONFIRMED THAT THIS DEVICE WAS SUBJECTED TO AND SATISFIED ALL CURRENT QUALITY STANDARDS SPECIFIED IN THE APPLICABLE DEVICE MASTER RECORD. THE USE OF A DIFFERENT MALE LUER FORCED THE FEMALE HUBS TO BREAK OFF.
THE INSTRUMENT WAS USED IN SEVERAL DIFFERENT CASES. IT WAS NOTED THE MECHANISM ON THE INSTRUMENT WAS STICKING AND NOT ABLE TO EXTRACT THE CEMENT FROM THE CARTRIDGE. THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE ROOT CAUSE OF THE EVENT IS ATTRIBUTED TO INADEQUATE CLEANING OF THE DEVICE AFTER USE.
THE DEVICE WAS USED FOR END-TO-END ANASTOMOSIS DURING A RIGHT HEMICOLECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE TISSUE AT THE APPLICATION SITE AND COMPLETED THE PROCEDURE WITH ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY
THE FILTER DID NOT FORM PROPERLY AFTER BEING DEPLOYED. THE FILTER FEET ANCHORED TO THE VESSEL WALL, HOWEVER THE DOME DID NOT FORM PROPERLY. NO PT INJURY OR COMPLICATIONS OCCURRED.
THE PLUNGER ON THE INSTRUMENT IS NOT WORKING PROPERLY. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT.
THE DEVICE WAS APPLIED DURING A VIDEO-ASSISTED THORACOSCOPY PROCEDURE. REPORTEDLY, THE CARTRIDGE DISENGAGED DURING USE. THE SURGEON USED ANOTHER  CARTRIDGE SUCCESSFULLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DOME TIP POINTED DOWNWARD WHEN PARTIALLY UNSHEATHED. ONCE THE FILTER WAS FULLY UNSHEATHED, THE DOME TURNED RIGHT SIDE UP AND WAS IN THE TARGET LOCATION.
DOME TIP POINTED DOWNWARD WHEN PARTIALLY UNSHEATHED. ONCE THE FILTER WAS FULLY UNSHEATHED, THE DOME TURNED RIGHT SIDE UP AND WAS IN THE TARGETED LOCATION. NO SAMPLE SUPPLIED. DEVICE HISTORY RECORD REVIEW WAS NOT POSSIBLE BECAUSE MFG LOT# WAS NOT SUPPLIED. WITHOUT A SAMPLE OR VALID LOT NUMBER, CO IS UNABLE TO CONFIRM THIS COMPLAINT.
A RIGHT FEMORAL LOCKING NAIL WAS ENGRAVED AS A LEFT NAIL. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: IT HAS BEEN VERIFIED THAT THIS LOT HAS NOT BEEN DISTRIBUTED IN THE US. THE LOT WAS INTERNATIONALLY DISTRIBUTED AND MANUFACTURED. REMEDAIL ACTION HAS BEEN TAKEN INTERNATIONALLY.
THE DEVICE WAS APPLIED DURING A VIDEO-ASSISTED THORACOSCOPY PROCEDURE. REPORTEDLY,THE CARTRIDGE DISENGAGED DURING USE. THE SURGEON USED ANOTHER CARTRIDGE SUCCESSFULLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING A TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE SURGEON COULD NOT CLOSE THE INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE PCI BALLOON WAS NOT INFLATING. IT APPEARED TO BE TORN. IT WAS REPORTED THE BALLOON WAS TESTED OUTSIDE THE BODY. IT IS UNKNOWN IF THERE ARE PIECES MISSING. ANOTHER PCI WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
TRACKING #.14166. DATE SENT: 10/21/1998. H6: BALLOON HAD A PUNCTURE. ENDOPATH PERCUTANEOUS CATHETER INTRODUCER: BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE CATHETER WAS RETURNED WITH A SMALL PUNCTURE IN TEH BALLOON. THE BALLOON WAS INFLATED, BUT LEAKED DUE TO THE PUNCTURE. NO CONCLUSION COULD BE REACHED AS TO HOW THE BALLOON HAD BECOME PUNCTURED.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT COULD NOT BE CLOSED ON TISSUE. THE SURGEON DID NOT HAVE ANOTHER INSTRUMENT, THEREFORE, HE RESECTED TISSUE AND COMPLETED THE PROCEDURE WITH MANUAL SUTURE. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.
10/4/96-SUBMISSION OF SUPPLEMENTAL REPORT WITH CORRECTED INFO IN SECTIONS B-4, D-5, D-6 (LOT #), F8, F-9 AND H-4. EVALUATION INDICATED AND ENTERED IN H3 AND H6.
NYLON STRAPS AT SLING ATTACHMENT POINT, STITCHING CAME APART (STRAPS DID NOT TEAR) STITCHING GAVE WAY, PT SLIPPED DOWN, THROUGH SLING, AND HIT HEAD ON FLOOR. PT REC'D LACERATION TO BACK OF HEAD. ONE PERSON INVOLVED AND INJURED.
CAUSE OF INCIDENT "USER ERROR". SLING IS CLEARLY LABELED WITH A SAFETY NOTICE STATING, "THIS SLING MUST BE REGULARLY INSPECTED FOR WEAR AND TEAR AND REPLACED IF NECESSARY". THE OPERATIONAL MANUAL FOR THE LIFT STATES, "WHEN USING THE EQUIPMENT ALWAYS MAKE SURE THAT ALL ATTACHMENTS, STRAPS, AND SEAMS OF THE SLING ARE IN GOOD CONDITION. IF THE SLING IS DAMAGED IN ANY WAY, IT SHOULD NOT BE USED". THE CUSTOMER HAS BEEN INSTRUCTED TO REVIEW THE OPERATIONAL AND SAFETY PRECAUTIONS OF OF THE LIFT MANUAL. FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING IS NO. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? YES. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING IS NO. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL IS YES. ADD'L INFO WILL NOT BE PROVIDED AFTER 15 DAY REPORT IS NO.
PT EXPERIENCED PAIN AND CREAKING IN RIGHT KNEE. REVISION SURGERY FOUND SEPARATION OF PATELLA'S U.H.M.W.P.E. DOME FROM METAL BACKING.
DAMAGE INCURRED IN TRANSIT FROM DISTRIBUTOR TO CO PREVENTS ANALYSIS OF    DEVICE.
THE DEVICE WAS USED DURING A THORACOSCOPIC WEDGE RESECTION PROCEDURE. REPORTEDLY, STAPLES DID NOT FORM PROPERLY AND THE KNIFE DID NOT COMPLETELY TRANSECT TISSUE. THE SURGEON APPLIED ANOTHER DEVICE. TEH HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING CHECK IN PROCEDURE, IT WAS NOTICED THAT ONE OF THE PEGS HAD BROKEN OFF. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCDURE. THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT.
SUMMARY OF EVALUATION: EVENT IS ATTRIBUTED TO EXCESSIVE STRESS AT THE PIN UNDERCUT. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO IMPROVE THE STRENGTH AND RELIABILITY OF THE PIN.
THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE ANVIL AND CENTER ROD COMPONENTS, TWO DETACHABLE COMPONENTS, DISENGAGED FROM THE INSTRUMENT AFTER FIRING. THE ANASTOMOSIS WAS COMPLETE AND THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE END WAS BENT AT BIT CLAMP RELEASE SITE. THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT OR DELAY IN SURGERY OR ANESTHESIA TIME REPORTED.
EVAL SUMMARY: THE MFR EVAL SUGGESTS THE DAMAGED TO BE CAUSED BY MISUSE OF THE DEVICE.
D5,6; H3,4,6;G4: ADDED ADDITIONAL INFO. D6; DEVICE RETURNED WITH NO LOT ID. CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL RESULTS, IT APPEARS LIKELY THAT THE FIRING HANDLE WOULD NOT CLOSE DOWN DUE TO THE INSTRUMENT BEING FIRED ACROSS A HARD OBJECT. THIS IS EVIDENCED BY THE VISIBLE DAMAGE TO THE KNIFE AND BREAKAWAY WASHER. ADDITIONALLY, UPON RECEIPT, IT WAS NOTED THAT THE KNOB WAS DETACHED FROM THE INSTRUMENT. IT APPEARS AS IF THE INSTRUMENT WAS DIALED OPEN BEYOND THE STOP OF THE INSTRUMENT. IT SHOULD BE NOTED THAT THE ADJUSTING KNOB SHOULD ONLY BE DIALED OPENED UNTIL THE ORANGE ON THE TROCAR IS VISIBLE. AS IT WAS STATED IN THE CLINICAL FOLLOW-UP THAT THE INSTRUMENT FIRED PREMATURELY WHILE OPENING THE INSTRUMENT, IT IS VERY IMPORTANT TO NOTE THAT THE SAFETY SHOULD BE ENGAGED UNTIL THE INSTRUMENT IS READY TO BE FIRED. THIS WILL PREVENT INADVERTENT MOVEMENT OF THE FIRING HANDLE AND THE INSTRUMENT FROM FIRING PREMATURELY. FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE INSTRUMENT. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
THE PT HAD BEEN BATHED AND WAS SAT ON THE LIFT SEAT OVER THE BATH, THE BATH WAS LOWERED AND UPON TRYING TO RAISE THE LIFT BY USE OF THE HANDLE THE SEAT SUDDENLY DROPPED APPROX. 1.5FT. NO INJURY TO PT OR NURSE. NO INJURY, TWO PERSON INVOLED.
INVESTIGATION FINDINGS: THE INVESTIGATOR E FOUND THAT THE LIFT SEAT WAS RAISED, NOT BY THE HANDLE ON THE LIFT BUT BY RAISING THE HI LO BATH, THEREBY CAUSING THE CHAIN TO BUNCH AND JAM IN THE MAST, WHEN THE BATHING WAS COMPLETED, THE BATH WAS LOWERED BUT THE SEAT REMAINED IN THE SAME POSITION, WHEN THE HANDLE WAS TOUCHED THE JIB, SEAT AND PT DROPPED. FOREIGN REPORTER'S CORRECTIVE ACTION: THE INVESTIGATOR HAS RECOMMENDED THAT THE LIFTING AND HANDLING CO-ORDINATOR DO MORE TRAINING, ESPECIALLY EMPHASIZING THE USE OF LIFTS IN CONJUCTION WITH HI LO BATHS. REPAIR SCHEDULED TO CHANGE/REVIEW CHAIN. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? YES. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? YES. ADD'L INFO WILL NOT BE PROVIDED AFTER 15 DAY REPORT IS NO.
THE BLADE IS SPINNING IN THE WORKING END OF THE INSTRUMENT. IT WAS NOTED THAT IT MAY BE STRIPPED. THERE WAS NO ADVERSE CONSEQUENCE OR DELAY IN SURGERY REPORTED.
EVAL SUMMARY: THE MFR EVAL SHOWS THE DEVICE TO BE OF AN OLDER DESIGN. THE DEIVE HAS BEEN CHANGED PREVENT THIS CONDITION.
PT DEVELOPED LARGE MASS IN THE BOTTOM OF THIS INCISION IN HIS THORACIC SPINE, DIAGNOSED AS A LARGE BURSA. THERE WAS DISLODGEMENT OF THE INFERIOR HOOKS ON THE INSTRUMENTATION.
IS FREQUENCY OR OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS FREQUENCY OF THIS EVENT GREATER THAN LABEL? NO. IS SEVERITY OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS THE SEVERITY OF THIS EVENT GREATER THAN LABELED? NO. A REPORT OR OTHER INFO SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE BY FDA OF THIS REPORT OR INFO, DOES NOT NECCESSARILY REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT OR BY FDA THAT THE REPORT OF INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, OR THE REPORTING ENTITY OR ITS EMPLOYEES OR AGENTS, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE REPORTING ENTITY NEED NOT ADMIT AND MAY DENY (AND EXPRESSLY RESERVES THE RIGHT TO DENY) THAT THE DEVICE, THE PARTY SUBMITTING THE REPORT, OR EMPLOYEES THEREOF, CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
THE BUTTON THAT RELEASES SCREWDRIVER BIT WAS FROZEN. THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT OR DELAY IN SURGERY OR ANESTHESIA TIME REPORTED.
THE SCREWDRIVER CLAMP WAS BROKEN DUE TO THE MISUSE OF THE DEVICE. THE CLAMPS HAVE BEEN MODIFIED WITH NEW VERSIONS.
THE DEVICE WAS USED DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, DIFFICULTY WAS EXPERIENCED REMOVING THE DEVICE FROM THE VAGINAL CUFF. THE DEVICE WAS MANIPULATED FROM THE APPLICATION SITE WITH NO PT INJURY REPORTED BY THE HOSP. THE SURGEON SUTURED TO COMPLETE THE PROCEDURE.
UPON OPENING THE INSTRUMENT CASE FRACTURE LINES WERE NOTICED ON THE INSTRUMENT HANDLES. UPON FURTHER EXAMINATION, THE PIECES CAME LOOSE FROM THE METAL BODIES. IT WAS REPORTED THE FRACTURE MAY HAVE OCCURRED DURING THE AUTOCLAVING PROCESS. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT.
SUMMARY OF EVALUATION: THE ROOT CAUSE OF THE EVENT IS ATTRIBUTED TO THE MATERIAL PROPERTIES OF THE HANDLE AT ELEVATED TEMPERATURES. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO IMPROVE RELIABILITY OF THE PLASTIC HANDLE.
DURING SERVICE OF PRODUCT A POTENTIAL NO LOW PRESSURE ALARM CONDITION WAS FOUND DUE TO TRANSDUCER BEING OUT OF SPECIFICATION. REPLACED TRANSDUCER.
THE DEVICE WAS APPLIED DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT LOCK ON THE VAGINAL CUFF. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE EXTRACTOR HANDLE BROKE WHILE BEING TIGHTENED. ALTERNATE INSTRUMENTATION WAS ON HAND FOR USE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE ROOT CAUSE OF THE EVENT IS ATTRIBUTED TO A COMBINATION OF MISUSE AND DESIGN FOR SPECIFIC APPLICATION. A NEW EXTRACTING DEVICE HAS OBSOLETED EXISTING DESIGN.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE "STAPLES WOULD NOT DELIVER." THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFORMATION NOT PROVIDED BY AFFILIATE. CONCLUSION: BASED ON THE INFORMATION RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS FIRED WITH THE RETURNED CARTRIDGE AND FIRED AND FORMED STAPLES AS DESIGNED WITH NO DIFFICULTIES NOTED. THE INCIDENT THAT OCCURRED DURING SURGERY COULD NOT BE RECREATED. THEREFORE, IT COULD NOT BE ASCERTAINED AS TO WHY THE STAPLES REPORTEDLY "WOULD NOT DELIVER".
TEH DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT RELEASE AFTER FIRING. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
AFTER DILATING INSIDE A STENT, THE CATHETER BALLOON RUPTURED. THE CATHETER WAS REMOVED WITH NO PT INJURY OR FURTHER COMPLICATIONS BEING REPORTED.
THIS INFORMATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS LIKELY TO IF THE EVENT WERE TO RECUR. BLOCK B6 & B7 WERE CHANGED TO "UNK" AS DEVERAL ATTEMPTS WERE MADE TO NO AVAIL OF GAINING THE INFORMATION. BLOCK D3 & F14 WERE INCORRECTLY SUPPLIED ON INITIAL REPORT. BLOCK H6, CONCLUSION CODE 68, CHOSEN AS THE PRODCUT WAS USED OUTSIDE THE LABELED INDICATIONS.
THE INSTRUMENTS WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE 355L BLADE WAS EXPOSED WHEN INSERTED. NO TISSUE WAS DAMAGED AS A RESULT. THE 511S TROCAR GASKET FELL INTO THE TROCAR SHAFT. IT DID NOT GO INTO THE PT AND WAS RETRIEVED FROM THE SHAFT WITHOUT DIFFICULTY. DR STATED HE WAS USING A RIGHT ANGLE THROUGH THE 511S WHEN THE GASKET FELL INTO THE TROCAR SHAFT. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT'S INNER GASKET "FELL INTO TROCAR SHAFT." THE GASKET WAS RECEIVED DETACHED INSIDE THE INSTRUMENT'S CANNULA. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED.
INITIAL IMPLANTATION OF PEDICLE SCREWS OCCURRED IN 1990. DUE TO BROKEN SCREWS AND PAIN, HARDWARE WAS EXPLANTED 8/7/96. FUSION HAD OCCURRED.
IS FREQUENCY OR OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? NO. IS SEVERITY OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS THE SEVERITY OF THIS EVENT GREATER THAN LABELED? N. A REPORT OR OTHER INFO SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT NECESSARILY REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT OR BY FDA THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, OR THE REPORTING ENTITY OR ITS EMPLOYEES OR AGENTS, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE REPORTING ENTITY NEED NOT ADMIT AND MAY DENY (AND EXPRESSLY RESERVES THE RIGHT TO DENY) THAT THE DEVICE, THE PARTY SUBMITTING THE REPORT, OR EMPLOYEES THEREOF, CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
REPORT OF ALLEGED "ALL LEDS, CONTINUOUS AUDIBLE ALARM, DEVICE WOULD NOT CYCLE. FOUND DURING BENCH TEST".
TESTING BY MFR FOUND DEVICE WOULD NOT CYCLE, WITH ALL LEDS AND A CONSTANT SINGLE TONE AUDIBLE ALARM, DUE TO INTEGRATED CIRCUIT U8 ON THE LOGIC BOARD BEING OUT OF SPECIFICATION. REPLACED U8.
DURING ROUTINE TESTING AT INSTALLATION OF UNIT. CO SERVICE REPRESENTATIVE NOTED OUTPUT OF VAPORIZER WAS NOT WITHIN SPEC. THE UNIT WAS FORWARDED TO CO VAPORIZER SVC CTR. THE REPORTED COMPLAINT WAS FOUND TO HAVE SLIPPED FROM THE PACKAGING INSERT DURING AN IMPACT TO THE SHIPPING CARTON. THE IMPACT CAUSED DAMAGE TO THE VAPORIZER BASE AND CHAMBER AND RESULTED IN A COLLAPSE OF THE BELLOWS ASSEMBLY. CO HAS SINCE SWITCHED TO USING SINGLE FOAM PACKAGING BOXES AND INSERTS FOR SHIPPING CALIBRATED VAPORIZERS WHICH WILL PROVIDE IMPROVED PROTECTION FROM IMPACT DAMAGE. INITIAL REPORT FROM THE FIELD 7/22/96. CONFIRMATION OF REPORTABLE EVENT 7/31/96.
DURING AN AV FISTULA PROCEDURE, THE CATHETER BALLOON RUPTURED. THE CATHETER WAS REMOVED AND REPLACED WITH A COMPETITOR'S MODEL TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS BEING REPORTED.
THIS INFORMATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT NOCCUR NOT IS LIKELY TO IF THE DEVENT WERE TO RECUR. BLOCK B6 AND B7 WERE CHANGED TO "UNK" AS DEVERAL AT TEMPS WERE WERE MADE DTO OBTAIN THE INFROMATION TO NO AVAIL. BLOCK D3 AND F14 WERE INCORRECTLY SUPPLIED ON INITIAL REPORT. B LOCK H6, METHOD CODE 86, CHOSEN AS NOT METHOD POSSIBLE AS SUSPECT DEVICE NOT RETUNRED.
THE DEVICE WAS USED DURING A TOTAL GASTRECTOMY. THE "SURGEON COULD NOT FIRE THE INSTRUMENT." THERE WAS NO CONSEQUENCE TO THE PT.
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
DURING A DILATATION PROCEDURE, THE CATHETER COULD NOT BE REMOVED THROUGH A 6 FRENCH SHEATH. THE CATHETER AND SHEATH WERE REMOVED AS A SINGLE UNIT AND  REPLACED WITH COMPETITOR'S PRODUCTS TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
9/24/96-CORRECTED INFORMATION SUMITTED FOR B-4 AND F-8. ADDITIONAL INFORMATION SUBMITTED FOR B-3, B-5, AND F-6. DEVICE EVALUATION INDICATED AND CODES ENTERED FOR H-3 AND H-6.
DURING ROUTINE TESTING AT INSTALLATION OF UNIT, CO SVC REP NOTED VAPORIZER WAS LEAKING AGENT. THE UNIT WAS FORWARDED TO VAPORIZER SVC CTR. THE VAPORIZER WAS FOUND TO HAVE SLIPPED FROM THE PACKAGING INSERT DURING AN IMPACT TO CHAMBER AND RESULTED IN A COLLAPSE OF THE BELLOWS ASSEMBLY. CO HAS SINCE SWITCHED TO USING SINGLE FOAM PACKAGING BOXES AND INSERTS FOR SHIPPING CALIBRATED VAPORIZERS WHICH WILL PROVIDE IMPROVED PROTECTION FROM IMPACT DAMAGE.
THE INSTRUMENT WAS USED DURING A RIGHT COLON RESECTION. IT WAS REPORTED THE SURGEON PLACED RIGHT COLON INTO JAWS OF TLC75, FIRED KNOB FORWARD, THEN MANUALLY HAD TO PULL BACK. WHEN THE INSTRUMENT WAS OPENED, ONLY HALF OF THE STAPLE LINE EXISTED, BUT STILL CUT COMPLETELY. SURGEON CLAMPED BLEEDING, THEN HAND SEWED TO ACQUIRE HEMOSTASIS. THE SURGEON RELOADED ANOTHER CARTRIDGE INTO SAME GUN, PUSHED FIRE KNOB FORWARD AND SAME SCENARIO OCCURRED. HALF OF STAPLE LINE STAPLED AND FULL CUT LINE. SURGEON CONTROLLED BLEEDING BY HAND SEWING AGAIN. REP RETURNING TWO TCR75 RELOADS, LOT NUMBER J4243R WITH INSTRUMENT. ONE IS IN THE INSTRUMENT (THE SECOND RELOAD USED). THE LOOSE RELOAD WAS FIRED FIRST. THERE WAS NO CONSEQUENCE TO THE PT. NO BUTTRESSING MATERIAL WAS USED.
D5; H3,4,6;G4: ADDED ADDITIONAL INFO. CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL INSPECTION, IT WAS CONCLUDED THAT THE WEDGE WAS DETACHED FROM THE PUSHER BLOCK. THEREFORE, THE STAPLES ON THE RIGHT SIDE OF THE CARTRIDGE WERE NOTE DRIVEN INTO THE ANVIL. IT COULD NOT BE ASCERTAINED AS TO WHERE OR HOW THE WEDGE HAD BECOME DETACHED. IT SHOULD BE NOTED THAT EACH INSTRUMENT IS 100% INSPECTED AND TESTED PRIOR TO SHIPMENT TO ENSURE THAT EACH INSTRUMENT IS CONFORMING. HOWEVER, EMPLOYEE AWARENESS SESSIONS WILL BE HELD AS A RESULT OF THIS INQUIRY. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
AFTER THE PUMP WAS IN USE FOR ONE HOUR, A BURNING ODOR WAS NOTED. THE PT WAS TRANSFERRED TO ANOTHER PUMP WITHOUT ANY COMPLICATIONS.
MFR CONTROL NO. DI960176 THE FIELD SVC REPRESENTATIVE INVESTIGATED THIS INCIDENT ON 8/9/96, AND FOUND THE PUMP'S RECORDER POWER BOARD WAS BURNT. IT APPEARS THAT THE USER SPILLED FLUID ONTO THE RECORDER. THE RECORDER WAS REPLACED AND A COMPLETE CHECK OF THE PUMP WAS PERFORMED AND IT WORKED NORMALLY.
SINGLE DISKECTOMY TO FUSE C5 & C6 VERTEBRAE PERFORMED. ONE DAY POSTOPERATIVELY A RADIOGRAPH REVEALED THE PLATE AND TWO SCREWS AT ITS BASE HAD MOVED TOGETHER APPROX 8 MM ANTERIORLY. PT HAS DIFFICULTY SWALLOWING AS A RESULT OF THE PLATE BASE CAUSING COMPRESSION OF THE OESOPHAGUS.
DEVCIE REMAINS IN PT. NO DECISION HAS YET BEEN MADE REGARDING EXPLANTATION.
CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
ON 8/15/96 0906 MESSAGE AND 800# LEFT FOR MD CALL BACK. TSB. 8/15/96 1545 SURGEON RETURNED CALL AND STATED THE EZ35 FIRED CORRECTLY ON THE FIRST FIRING. ON THE SECOND FIRING, IT WOULD NOT CLOSE. THE SURGEON REMOVED THE DEVICE FROM THE BODY AND OPENED AND ATTEMPTED TO CLOSE THE DEVICE OUTSIDE THE BODY. IT WOULD NOT CLOSE. THE CASE WAS COMPLETED WITH SCISSORS AND ELECTROCAUTERY. KJB. 8/20/96 1230 CIN ATTEMPTED TO REACH CONTACT, AND WAS TOLD HE WOULD BE IN TOMORROW. BAH. 8/20/96 1235 COURTESY RISK MANAGER. SHE WILL TRY TO OBTAIN PATIENT INFORMATION. BAH. 8/21/96 1520 ATTEMPTED TO REACH CONTACT, HE LEFT FOR THE DAY. TKB. 8/22/96 1008 CONTACT REPORTED THE SURGEON WAS HAVING TROUBLE GETTING THE INSTRUMENT TO STAY CLOSED. SHE FINALLY GOT THE INSTRUMENT TO STAY CLOSED AND FIRED WITHOUT DIFFICULTY. ON A SUBSEQUENT RELOAD, THE JAWS WOULD NOT OPEN WITHOUT PRYING THEM OPEN AFTER INSERTING INSTRUMENT IN TROCAR. THEN IT WOULD NOT FIRE AT ALL. HE COULD NOT REMEMBER HOW THE INSTRUMENT WAS COMPLETED. PATIENT INFO AS FOLLOWS: EAB, MR #114695, DOB 1-27-1970, FEMALE, UNK WEIGHT. TSB.
DURING A HELICOPTER TRANSPORT, THE PT, A 8 MONTH OLD FEMALE WITH SEVERE HEAD TRAUMA, DID NOT RECEIVE THE PRESCRIBED VOLUME OF OXYGEN. THE HOSP DETERMINED THAT THE DIAPHRAGM IN THE PEEP ACCESSORY OF THE MANUAL RESUSCITATION BAG WAS MISSING FROM THE ASSEMBLY. THE PT REPORTEDLY DIED THE NEXT DAY. THE CUSTOMER REPORTED IN A SUBSEQUENT TELEPHONE CALL THAT THE DEVICE DID NOT CAUSE THE PT'S DEATH BUT WAS A CONTRIBUTING FACTOR. THE CAUSE FOR THE MISSING DIAPHRAGM WAS DETERMINED TO BE OPERATOR ERROR AND IS STILL UNDER INVESTIGATION BY THE INSTITUTION. THIS REPORT IS NOT AN ADMISSION BY CO THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
ON 8/6/96, THE MFR RECEIVED A REPORT FROM ITS DISTRIBUTOR. DURING THE DISTRIBUTOR'S INSPECTION OF THE DEVICE IT WAS NOTED THAT TWO UNITS CONTAINED A HAIR IN THE PACKAGE, SIX UNITS CONTAINED FOREIGN MATTER IN THE PACKAGE AND ONE UNIT HAD A FLAW IN THE DEVICE LABELING. ADDITIONALLY, THE BOX-PACKAGE IS PACKAGED TEN UNITS TO A BOX/PACKAGE; HOWEVER, THE BOX/PACKAGE ONLY CONTAINED NINE.
THE DEVICE HAS BEEN RETURNED TO THE MFR AND IS PRESENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE PT'S HEMATOCRIT DROPPED POST-OPERATIVELY. APPROX EIGHT HRS POST-OPERATIVELY THE SURGEON RE-OPERATED ON THE PT. HE DID A LAPAROSCOPY. THE STAPLE LINE WAS BLEEDING AND AN ENDOLOOP WAS USED ON THE STAPLE LINE TO CONTROL THE BEEDING. THE PT LOST APPROX 500CC OF BLOOD. IT IS UNKNOWN IF THE PT RECEIVED ANY BLOOD. THE PT IS DOING FINE AT THIS TIME.
D6; DEVICE RETURNED WITH NO LOT ID. 08/26/1996 DR TRIED TO CONTACT THE SURGEON. SENT NO CONTACT LETTER.
MFR CONTROL NO. IC96363. THE BALLOON ON THE RETURNED CATHETER HAD A TEAR IN THE CTR (LONGITUDINAL) OF THE BANDED BALLOON. FAILURES OF THIS TYPE HAVE BEEN FOUND TO BE A NATURAL RESULT OF WEAKNESS IN THE LATEX FILM THAT CAN BE CAUSED BY VARIOUS EXTERNAL FACTORS SUCH AS, IMPROPER STORAGE CONDITIONS (HEAT, LIGHT, HUMDITY) OR EXCESSIVE PHYSICAL STRESS (OVER INFLATION) OF THE BALLOON. IN THIS PARTICULAR INCIDENT NEITHER THE PHYSICAL STRESS TO THE BALLOON NOR ITS STORAGE CONDITIONS ARE KNOWN.
SURGEON REMOVED A P.F.C. FEMORAL HIP HEAD, AS WELL AS A BIPOLAR LINER, MDR REPORT # 1219655-1996-00002, AND A BIPOLAR SHELL, MDR REPORT #1219655-1996-00003, DUE TO DISLOCATION OF THE FEMORAL HEAD FROM THE LINER/SHELL ASSEMBLY.
THE DEVICE IS BEING RETURNED TO CO FOR EVAL.
THE EZ35BS AND THE EZ45B WERE USED DURING A TOTAL ABDOMINAL HYSTERECTOMY. THE EZ35B (SERIAL # 0579) WAS FIRED 2 TIMES SUCCESSFULLY. ON THE 3RD FIRING THE EVU35 WAS USED AND THE STAPLER WOULD NOT RELEASE. THE SURGEON CUT THE DEVICE OUT AND ANOTHER EZ35B (SERIAL# 0158) WAS OPENED. IT WAS FIRED 2 TIMES SUCCESSFULLY. ON THE 3RD FIRING THE EVU35 WAS USED AND THE DEVICE WOULD NOT CLOSE PROPERLY. IT REQUIRED FORCE TO CLOSE THE DEVICE. THE SURGEON WENT TO FIRE THE DEVICE AND IT WAS "LOCKED-OUT." AN EZ45B (SERIAL 0514) WAS OPENED. IT WAS FIRED AND STAPLED, BUT IT DID NOT CUT. SCISSORS WERE USED TO DIVIDE THE STAPLE LINE. THE CASE WAS COMPLETED USING CLAMPS AND SUTURES. IT WAS REPORTED AN ADD'L HR WAS ADDED TO THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2; B6,7; D10 - INFO UNAVAILABLE. SEE CORRESPONDENCE LOG: 8/15/96 1641 MESSAGE AND 800# LEFT ON DOCTOR'S ANSWERING MACHINE.KJB8/16/96 NNCL SENT. TSB 8/20/96 1445 LEFT COURTESY CALL MESSAGE FOR RISK MANAGER. BAH8/21/96 1500 DR. CALLED AND CONFIRMED THE INFO AS REPORTED BY THE SALES REP. HE DID HAVE TO EXCISE THE FIRST EZ35, THEN THE SECOND ONE LOCKED OUT. HE STATED HE WAS VERY CAREFUL NOT TO PRE-FIRE THE INSTRUMENT AND THERE WAS NOT TOO MUCH TISSUE IN THE JAWS. THE EZ45 WAS OPENED AND STAPLED BUT DID NOT CUT. PATIENT WAS 5'1", 260#, FEMALE. TSBD5; H4: INFO UNAVAILABLEG3: USER FACILITY WAS INCORRECTLY SELECTED ON INITIAL MEDWATCHBASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "DID NOT CUT PROPERLY" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
DURING USE IN THE LEFT ATRIUM, THE PHYSICIAN OVER INFLATED THE BALLOON TO IMPROVE FLOTATION. THE PHYSICIAN WAS OBSERVED YANKING THE CATHETER BACK AND FORTH. THE BALLOON RUPTURED AND WHEN THE CATHETER WAS REMOVED, THE BALLOON WAS MISSING. THERE WERE NO REPORTED PT COMPLICATIONS. THE REPORTER STATED THAT THE USER CAUSED THIS EVENT.
PLEASE NOTE THAT ALL INFO IN SECTIONS A, B, D, E AND F WERE NOT PROVIDED INITIALLY BY THE USER FACILITY AND MFR IS PROVIDING THIS INFO BASED ON CASE INVESTIGATION. ANY INFO NOT PROVIDED IS UNKNOWN OR UNAVAILABLE TO THE USER FACILITY. THE DEVICE EVALUATION INFO PROVIDED IS BASED ON EVALUATION OF THE HANDPIECE IN WHICH THE BUR BROKE. THE REMAINDER OF THE BUR WAS NOT SENT IN FOR EVALUATION. WHERE DATES ARE SHOWN AS "00/00/0000", THE DATE IS UNKNOWN (UNK), ACCEPT IN SECTIONS B2, D5, D7, D8, D11, AND D13 WHERE THE DATE IS NOT APPLICABLE (NA). INSPECTION CONFIRMED BROKEN BIT. TESTING THE DEVICE COULD NOT DUPLICATE THIS MALFUNCTION UNDER NORMAL CONDITIONS. TESTING REVEALED THAT THE MOTOR DID NOT MEET SPECS. THIS CONDITION COULD NOT HAVE CAUSED THE BUR BREAKAGE. THE BUR BEING USED IS DESIGNED FOR LIMITED SPEED USE ONLY (60% POWER). THE SURGICAL TECHNICIAN, STATED THAT THE DRILL WAS BEING RUN AT 100% POWER WHEN THE MALFUNCTION OCCURRED.
THE EZ35BS AND EZ45B WERE USED DURING A TOTAL ABDOMINAL HYSTERECTOMY. THE EZ35B (SERIES # 0579) WAS FIRED 2 TIMES SUCCESSFULLY. ON THE 3RD FIRING THE EVU35 WAS USED AND THE STAPLER WOULD NOT RELEASE. THE SURGEON EXCISED THE INSTRUMENT AND ANOTHER EZ35B (SERIAL # 0158) WAS OPENED. IT WAS FIRED 2 TIMES SUCCESSFULLY. ON THE 3RD FIRING THE EVU35 WAS USED AND THE DEVICE WOULD NOT CLOSE PROPERLY. IT REQUIRED FORCE TO CLOSE THE DEVICE. THE SURGEON WENT TO FIRE THE DEVICE AND IT WAS "LOCKED-OUT." AN EZ45B (SERIAL # 0514) WAS OPENED. IT WAS FIRED AND STAPLED, BUT IT DID NOT CUT. SCISSORS WERE USED TO DIVIDE THE STAPLE LINE. THE CASE WAS COMPLETED USING CLAMPS AND SUTURES. IT WAS REPORTED AN ADD'L HR WAS ADDED TO THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: RETURNED WITH BROKEN FIRING TRIGGER TEETH, BROKEN SHORT RACK TOOTH AND BENT/KNICKED KNIFE. CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT A WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND WAS FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. INSTRUMENT B WAS RETURNED WITH A BENT KNIFE AND BENT WEDGES, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. THE CARTRIDGE RETURNED WITH INSTRUMENT B WAS MISSING THE LOCKOUT TAB AND THE MIDDLE ALIGNMENT FINGER. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. INSTRUMENT B WAS CYCLED, FIRED AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION, BUT HAD A ROUGH CUT DUE TO THE DAMAGED KNIFE. NO CONCLUSION COULD BE REACHED AS TO HOW THE KNIFE HAD BECOME DAMAGED. COMMENTS: SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS TO CONTINUOUSLY IMPROVE THE PRODUCTS.
MEMBRANE PRESSURE INCREASED TO 600 MMHG DURING PROCEDURE. AFTER APPROX 1 HOUR, THE DEVICE WAS CHANGED OUT DUE TO INSUFFICIENT GAS EXCHANGE. PT WAS NOT INJURED AS A RESULT OF THE INCIDENT.
ALL "UNK" ENTRIES, INFORMATION  REQUESTED AND NOT REC'D. INFO IN SECTION F PROVIDED BY MFR. SECTION F10 DEVICE CODES 1461 AND 1491 NOT LABELED.
SURGEON REMOVED CO'S FEMORAL HIP HEAD DUE 9/11/96 DUE TO DISLOCATION. THE COMPONENT HAD BEEN IMPLANTED ON 7/10/96.
H2-DIMENSIONAL INSPECTION OF RETURNED HIP HEAD FOUND COMPONENT TO MEET SPECIFICATION REQUIREMENTS. DIMENSIONAL ANALYSIS AND CANTILEVER TESTING OF 1 HIP HEAD COMPONENT FROM THE SAME BATCH WERE FOUND TO MEET PRODUCT SPECIFICATION REQUIREMENTS. NO FURTHER INVESTIGATION IS PLANNED.
EVACUATION OF RT HEMATOMA AND EXCHANGE OF SALINE IMPLANT.
DURING A TURP PROCEDURE, THE PT EXPERIENCED EXCESSIVE BLEEDING WHICH WAS NOT BROUGHT UNDER CONTROL FOR APPROX 1 & 1/2 HRS. BEYOND NORMAL SURGERY TIME. THE BLOOD LOSS WAS 300CC RATHER THAN THE EXPECTED 25CC. THE PT WAS STABLE, BUT BEING WATCHED FOR FURTHER BLEEDING. THEY TRIED TO CONTROL THE BLEEDING WITH DESICATE, FLUGERATE, SPRAY AND CONTINUED TO INCREASE COAG.
THE GENERATOR HAS NOT BEEN RETURNED TO CO. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY.
THE DEVICE WAS USED DURING A HYSTERECTOMY. IT WAS REPORTED THAT "JUST TWO STAPLES ON THE LINE STAPLES." A NEW INSTRUMENT WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS WERE FALLING OUT OF THE JAWS OF TWO NEW CLIP APPLIERS. THERE WAS NO CONSEQUENCE TO THE PT. SALES REP TO CALL BACK WITH FURTHER INFO.
THE CLIP APPLIERS IN QUESTION ARE APPROX 4-5 MONTHS OLD AND THE CLIP DROPPING STARTED A COUPLE OF MONTHS AGO. IT HAS BEEN AN ONGOING PROBLEM SINCE THEN. ONE OF THE APPLIERS BEING RETURNED DROPS CLIPS EVEN BEFORE THE APPLIER IS INTRODUCED INTO THE PT. CLIPS HAVE FALLEN INTO THE PT'S ABDOMEN AND WERE RETRIEVED WITHOUT DIFFICULTY.
MEDICAL ATTENTION WAS REQUIRED AFTER EXPERIENCING AN INSERTER INJURY.
510K #912002. 1 PERSON. SERIOUS INJURY. TYPE G. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL?
THE INSTRUMENT WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. STAPLE LINE BLEEDING WAS REPORTED. THE BLEEDING WAS SECURED BY CLIPS. A NEW LINEAR CUTTER OPENED TO FINISH THE CASE. NO BUTTRESSING MATERIAL WAS USED. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVAL: CONCLUSION BASED UPON INQUIRY INFO RECEIVED, VISUAL EXAMINATION, AND FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY INSTRUMENT REPORTEDLY PRODUCED "STAPLE LINE BLEEDING" DURING SURGERY. INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED STAPLES WITHIN DESIGN SPECIFICATION. INSTRUMENT WAS DISASSEMBLED TO EXAMINE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
A PT WAS TREATED IN APPROX 1995 (EXACT DATE UNAVAILABLE), IN THE NASOLABIAL FOLDS. IN APPROX. 7/96, THE PT PRESENTED WITH PAIN, ERYTHEMA, AND SWELLING OF THE EXTERNAL EARS. THE PHYSICIAN DIAGNOSED RELAPSING POLYCHONDRITIS; PREDNISONE WAS PRESCRIBED. THE TREATMENT SITES REMAINED ASYMPTOMATIC. THE PHYSICIAN DID NOT BELIEVE THAT THE SYMPTOMS WERE RELATED TO COLLAGEN. THIS EVENT IS BEING REPORTED AS AN MDR AS PER AGREEMENT WITH THE FDA TO REPORT ALL AUTOIMMUNE DISEASE EVENTS, REGARDLESS OF THE PHYSICIAN'S STATEMENT OF CAUSALITY.
A REVIEW OF THE EVENT REVEALED THE OUTCOME WAS REQUIRED INTERVENTION INSTEAD OF PERMANENT DAMAGE.
510K #950928. 1 PERSON. SERIOUS INJURY. TYPE G. IS FREQUENCY OF OCCURRENCE FOTHIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT       ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
THE PPW35 WAS USED DURING AN ORTHOPEDIC PROCEDURE. THE STAPLES WERE MALFORMED. ANOTHER PPW35 WAS OPENED TO COMPLETE THE CASE. IT IS UNKNOWN WHETHER THE STAPLER WAS SQUEAKING. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: MAGAZINE PARTIALLY BROKEN AWAY FROM HANDLE.
TWO WEEK FOLLOW-UP X-RAY SHOWED THAT SADDLES AT S1 HAD SLIPPED OUT OF SCREWS. REVISION SURGERY DONE ONE MONTH POST-OP.
WHILE INSPECTING THE INSTRUMENT, IT WAS NOTICED, THE PEGS WERE BENT AND STARTING TO BREAK OFF. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND WAS NOTED THIS OCCURRED OVER TIME.
THE RESULTS OF THE EVALUATION PERFORMED, INDICATED THE ROOT CAUSE OF THE PIN DEFORMATION IS ATTRIBUTED TO PIN LENGTH AND HEAT TREAT PROCESS AFTER WELDING IN COMBINATION WITH OVER STRESS FROM THE USER. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO CHANGE PIN LENGTH AND MATERIAL HARDNESS.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. "IT WAS REPORTED WHEN THE ANVIL WAS ATTACHED, DEVICE FIRED AN AUDIBLE FEEDBACK WAS HEARD AS NORMAL. WHEN THE DEVICE WAS RELEASED TO CHECK DONUTS, THE DONUTS WERE FOUND TO BE STUCK TOGETHER AND THE STAPLES SEEMED INADEQUATELY CLOSED. THE BOWEL WAS TRIMMED OF THE STAPLE LINE. A SECOND DEVICE WAS USED AND SUCCESSFULLY COMPLETED THE PROCEDURE." THERE WAS NO CONSEQUENCE TO THE PT. DATE DEVICE EXPIRES: 2001.
BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. UPON RECEIPT, IT WAS NOTED THAT THE BREAKAWAY WASHER WAS IN THE ANVIL UPSIDE DOWN. WITH THE BREAKAWAY WASHER UPSIDE DOWN, IT DID NOT PROVIDE THE CUTTING SURFACE NECESSARY FOR THE TISSUE TO CUT. ALSO, THE INSTRUMENT WILL NOT GIVE THE TACTILE FEEDBACK NECESSARY TO INDICATE THAT THE STAPLES WERE ADEQUATELY FORMED. AS EVERY INSTRUMENT IS INSPECTED THROUGH AN AUTOMATED VISION SYSTEM, IT COULD NOT BE DETERMINED AS TO HOW THE WASHER WAS RETURNED IN THE WRONG POSITION. HOWEVER, AN EMPLOYEE AWARENESS SESSION WILL BE HELD AS A RESULT OF THIS INQUIRY. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
THE TIP BROKE OFF THE END OF THE IMPACTOR. THE BROKEN PIECE WAS REMOVED FROM THE STEM AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE CONSEQUENCE OR THE PT.
SUMMARY OF EVAL: THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO THE USER NOT FULLY TIGHTENING THE INNER ROD TO THE IMPLANT. THIS RESULTED IN MAXIMUM STRESS AT THE EXPOSED THREAD AND SUBSEQUENT FAILURE. THE AGENT WAS ALERTED TO INSTRUCT THE USERS ON PROPER USE OF THE INSTRUMENT.
THE LAVH WAS PERFORMED APPROX 1 MONTH AGO. EVERYTHING LOOKED FINE DURING THE CASE. PT HAD TO BE RE-OP'D AT A LATER DATE DUE TO A BOWEL OBSTRUCTION. THE GENERAL SURGEON NOTED A COUPLE STAPLES HAD HOOKED THE BOWEL FROM THE STAPLE LINE ACROSS THE IP LIGAMENT.
A1,2,4;B3,6,7;D10: INFORMATION UNAVAILABLE: D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
ON 8/8/96, A MFR'S CLINICAL REP WAS PRESENT IN THE FACILITY'S OR WHEN THE REFILL TUBING SET WAS PLACED ON THE SCRUB TABLE. THE OR RN ATTEMPTED TO DISCONNECT THE HEPARIN LOCK ON THE TUBING; HOWEVER, HE WAS UNSUCCESSFUL. IT WAS ALSO NOTED THAT THERE WERE NO WINGS ON THE DEVICE TUBING. THE MFR'S CLINICAL REP GAVE THE OR SCRUB NURSE AN EXTRA SET OF REFILL TUBING TO COMPLETE THE DEVICE PRIMING PROCEDURE.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALZED AS FOLLOWS: NO NICKS, CUTS, HOLES, CRACKS, SOLVENT WELD BOND VOIDS WERE NOTED DURING THE VISUAL/MICROSCOPIC EXAM OF THE DEVICE. THE DEVICE WAS ANOMALY FREE. FURTHER VISUAL/MICROSCOPIC EXAM OF THE DEVICE REVEALED THE ABSENCE OF "WINGS FROM THE DISTAL AND PROXIMAL END LUER LOCKS. ADDITIONALLY, IT WAS NOTED THAT THE INJECTION CAP AT THE PROXIMAL END OF THE DEVICE APPEARED PERMANENTLY ATTACHED, CONFIRMING THE CUSTOMER'S COMPLAINT THAT "THE FACILITY RN WAS UNABLE TO DISCONNECT THE HEPARIN LOCK ON THE DEVICE TUBING AND THE DEVICE TUBING DID NOT HAVE ANY WINGS." HOWEVER, THIS UNIT WAS BUILT PRIOR TO 3/92, TO THE MFR'S SPECS WHICH CALLED FOR THE HEPARIN LOCK TO BE GLUED ON. THIS DEVICE WAS LATER RE-DESIGNED WITH REMOVABLE/UNGLUED CAP AND WINGS. THIS DEVICE PERFORMED AS INTENDED; HOWEVER, IT IS AN OBSOLETE DESIGN THAT WAS STILL IN THE FACILITY INVENTORY. NO FURTHER DETAILS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIPS FELL OUT OF THE JAWS. A SECOND APPLIER WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D10-INFORMATION NOT PROVIDED BY USER FACILITYH4,D5,6-INFORMATION NOT AVAILABLEG3:USER FACILITY WAS INCORRECTLY SELECTED ON INITIAL MEDWATCHBASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY AHVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WIHTIN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CLIPS WERE EJECTING OUT OF THE APPLIER, ONE CLIP DID NOT FORM. THERE WAS NO CONSEQUENCE TO THE PT.
SURGEON REPORTED DIFFICULTY PRECLOTTING VASCULAR PROSTHESIS DURING AORTAL-BIFEMORAL BYPASS PROCEDURE. THREE ATTEMPTS WERE MADE TO PRECLOT THE GRAFT USING THE PT'S BLOOD, AFTER WHICH THE SURGEON APPLIED HOECHIST'S PERIPLAST AND REPEATED THE PRE-CLOTTING STEP. APPROX. 10 MINUTES AFTER FINAL SUTURING, THE SURGEON NOTICED OVERALL BLEEDING OF THE GRAFT, AND THE PT'S ACTIVATED CLOTTING TIME (ACT) WAS 110 MIN. BLEEDING WAS SUCCESSFULLY ARRESTED WITH THE ADMINISTRATION OF ARONALPHA.
H6-VALIDATION RECORDS FOR KNITTING MACHINE SET-UP WERE REVIEWED AND WATER PERMEABILITY RESULTS INDICATE CONFORMANCE TO DEVICE SPECIFICATIONS. DUE TO DATE OF MFG (1991), THERE IS NO PRODUCT REMAINING FROM THE MFG BATCH TO ALLOW FOR INSPECTION OF SIMILAR PRODUCT. CAUSE OF GRAFT LEAKAGE HAS NOT BEEN DETERMINED. A PORTION OF THE COMPLAINT GRAFT WAS RETURNED TO THE MFR IN CONTAMINATED CONDITION (PRECLOTTED WITH BLOOD), PRECLUDING WATER PERMEABILITY TESTING OF THE FABRIC. THE MFR HAS ATTEMPTED TO OBTAIN ADD'L INFO FROM DISTRIBUTOR ABOUT PT HISTORY, RISK FACTORS SUCH AS COAGULOPATHIES, AND USE OF ANTI-COAGULATIVES PRIOR TO OR DURING THE SURGICAL PROCEDURE, WHICH MAY HAVE CONTRIBUTED TO CLOTTING PROBLEMS. NO OTHER REPORTS OF CLOTTING DIFFICULTIES HAVE BEEN REPORTED FOR THE MFG BATCH. IF APPLICABLE INFO IS RECEIVED FROM THE SOURCE CONTACT, A SUPPLEMENTAL REPORT WILL BE FILED BY THE MFR WITHIN 30 DAYS OF RECEIPT. ALL INFO APPEARING ON THE MEDWATCH FORM HAS BEEN COMPLETED BY THE MFR ON BEHALF OF A FOREIGN DISTRIBUTOR.
DISTAL TIP OF DEVICE WAS REPORTED TO HAVE BROKEN DURING SURGERY.
DEVICE EVAL REVEALED MACHINING TOOL MARK EVIDENT WHICH MAY HAVE CAUSED INTERFERENCE DURING USE RESULTING IN BROKEN TIP. NO PT INJURY OR SIGNIFICANT SURGICAL DELAY WAS REPORTED. "SMITH AND NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH AND NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH AND NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH AND NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH AND NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT".
BLOOD DONOR WAS INCISED WITH A CO'S FINGERSTICK DEVICE AS PART OF THE PROCEDURE TO DONATE BLOOD DURING A MOBILE BLOOD DRIVE. TWO (2) DAYS LATER, THE DONOR STILL HAD A BRUISE AND SORENESS WHICH "FELT LIKE A THORN". THE DONOR EXAMINED THE INCISION UNDER A LIGHT AND PRIED APART THE SKIN. A "LITTLE SLIVER" OF METAL CAME TO THE SURFACE.
THE CHAMBER COLLAPSED DURING THE PROCEDURE. THE MACHINE WAS CHANGED TO COMPLETE CASE. THERE WAS NO PERMANENT INJURY REPORTED.
A COMPANY SERVICE REP CHECKED THE SYSTEM AND HANDPIECE AND FOUND THEM BOTH TO MEET THEIR PERFORMANCE SPECIFICATIONS. PT INFO HAS BEEN REQUESTED FROM REPORTER, BUT HAS NOT BEEN RECEIVED TO DATE.
THE DEVICE WAS IMPLANTED APPROX 1 1/2 YRS. AGO FOR INTRATHECAL INFUSION OF MORPHINE. (NOTE: INTRATHECAL INFUSION OF MORPHINE WAS NOT A MFR'S INDICATION FOR THE DEVICE'S INTENDED USE.) ON 8/29/96, THE FACILITY NURSE CONTACTED A MFR NURSE AND REPORTED THAT THE DEVICE WAS REFILLED ON 8/26/96. ON 8/27/96, THE PT COMPLAINED OF BEING SWEATY, NERVOUS, FELT SYMPTOMS OF WITHDRAWAL AND WAS IN SEVERE PAIN. THE PT WAS SEEN IN THE ER AND GIVEN AN INJECTION OF MORPHINE SULFATE. THE DEVICE FLOWRATE WAS CONSTANT AT 1.4 ML/DAY; DOSE WAS 11-12 MG/DAY. A DEVICE REFILL KIT WAS UTILIZED AND AN INITIAL CHECK OF THE RETURN FLOW WAS PERFORMED AFTER POSITIONING THE DEVICE NEEDLE; HOWEVER, THE DEVICE WAS NOT RECHECKED EVERY 5 CC'S. THE MFR RN SUGGESTED THAT A DEVICE SIDEPORT STUDY BE PERFORMED TO DETERMINE POSITION OF THE DEVICE CATHETER. THE PREDICTED FLOWRATE FOR THIS DEVICE IS 1.71 ML/DAY. PRODUCT INSTRUCTIONS AND LITERATURE WERE SENT. IN ADDITION, CLINICAL SUPPORT WAS OFFERED FOR FURTHER ASSISTANCE.
FURTHER COMM VIA THE MFR RN, ON 9/10/96, REVEALED THAT THE DEVICE FLOW RATE REMAINS APPROPRIATE. IT WAS ADDITIONALLY STATED THAT THE PT HAD SURGERY PRIOR TO THIS EVENT AND DIAZEPAM WAS DISCONTINUED ABRUPTLY. IN THE ER THE PT WAS GIVEN DIAZEPAM IN ADDITION TO MORPHINE SULFATE. THE DR REORTEDLY FEELS THAT THIS EVENT WAS DUE TO DIAZEPAM WITHDRAWAL AND WAS UNRELATED TO THE DEVICE. AS PART OF CO INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND REVEALED THAT ALTHOUGH NOT PART OF THE MFR'S ORIGINAL 10/92 DEVICE SAFETY ALERT, INSTRUCTIONS PROVIDED IN THE ALERT GUIDELINES APPLY TO THIS DEVICE. NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. THE DEVICE REMAINS IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY. BASED ON THE INFO AVAILABLE THIS EVENT DOES ONT APPEAR TO BE DUE TO THE DEVICE OR A DEVICE MALFUNCTION, BUT DUE TO THE ABRUPT DISCONTINUATION OF THE DIAZEPAM THE PT HAD BEEN TAKING. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
DURING DIALYSIS TREATMENT, THE FACILITY NOTICED UNUSUAL ARTERIAL/VENOUS PRESSURES. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN FOUND A BROKEN BLOOD PUMP ROTOR SPRING AND REPLACED IT WITH A NEW ROTOR. THERE WERE NO PT INJURIES OR INTERVENTIONS REPORTED. TEST PROCEDURE FOLLOWED: QARA 146. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INVESTIGATED AND CONFIRMED THAT ONE OF THE ROTOR SPRINGS WAS BROKEN. THE MES REPLACED THE BLOOD PUMP ROTOR AND FUNCTIONALLY TESTED THE MACHINE. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW. THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND/OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATMOSPHERIC PRESSURE. THIS ALARM GENERATES A VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE MFR CONCLUDES THAT THE BROKEN SPRING ON THE BLOOD PUMP ROTOR CAUSED THE DIFFICULTY READING THE ARTERIAL AND VENOUS PRESSURES. THE ABOVE INFO INDICATES THAT THE DIFFICULTY READING THE ARTERIAL AND VENOUS PRESSURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960018. CUSTOMER CONTACTED:Y. SALES/SERVICE CONTACTED BY INVESTIGATOR?N. TRAINING REQUIRED?N. REPORT ATTACHED?.N.
BACK OF WOODEN CHAIR FRAME BROKE. HUSBAND STATED WHEN CHAIR BACK BROKE HIS WIFE WAS TAKEN TO THE HOSP. FOLLOW UP PHONE CALL BY CO TECHNICAL SVC PERSON ON 8/27/96, USERS HUSBAND STATED HIS WIFE WAS JUST SHOOK UP AND HAD NO PROBLEM.
THE WOODEN FRAME BACK HAS BEEN SEPARATED FROM THE WOODEN SEAT FRAME. SEE ATTACHED DRAWING. CHAIR BACK IS ATTACHED TO SEAT BY TWO DOWELS, WOOD BLOCKS, WOOD GLUE AND 1 1/2" STAPLES ON EACH SIDE OF FRAME. THE WEIGHT CAPACITY OF THIS MODEL CHAIR IS 250LBS. POSSIBLE CAUSE OF THE FRAME BREAKING WOULD BE USE OF THE CHAIR IN EXCESS OF ITS CAPACITY. THE FRAME HAS BEEN ASSEMBLED PROPERLY AND SHOULD NOT HAVE BROKEN UNLESS IT HAD BEEN SUBJECTED TO ABNORMAL USE.
THE VENTILATOR WAS CONNECTED TO A PT. THE CUSTOMER REPORTS THAT THE VENTILATOR'S FIO2 WAS SET TO 60%. AFTER THE PT WAS SUCTIONED THE FIO2 DROPPED TO 21% THEN GRADUALLY INCREASED TO 60%.
THE OXYGEN GAS MODULE WAS REPLACED BY CO FIELD ENGINEER.
LASER FIBER BROKE ABOVE THE GOLD TIP AS IT WAS INSERTED INTO THE ROPE DURING A CYSTOSCOPY, LEFT URETHROSCOPY, ATTEMPTED LASER LITHOTRIPSY AND ELETROHYDRAULIC LITHOTRIPSY OF A LEFT DISTAL URETERAL STONE. X-RAY TAKEN. NO FOREIGN BODY NOTED. NO INJURY TO PT.
THE VENTILATOR WAS CONNECTED TO A PT. THE CUSTOMER REPORTS THAT THE VENTILATOR DELIVERED AN FIO2 OF 100% WHEN SET TO 50%.
AN AIR GAS MODULE WAS REPLACED BY CO FIELD ENGINEER.
THE THREE BROKEN SEGMENTS FROM THE DISTAL 16 3/8" OF THE FIBER WERE EVALUATED. IN GENERAL, BREAKS EXHIBITED CHARACTERISTICS SIMILAR TO BREAKING DUE TO BEING BENT TOO TIGHT. SOME ASPECTS WERE UNDETERMINABLE DUE TO CONTINUED USEAGE FACTORS. THE REMAINING 19FT 2IN OF FIBER WAS ASSESSED WITH NO DEFECTS NOTED. BREAKAGE OBSERVED BY THE CUSTOMER IS BELIEVED TO BE RELATED TO THE FIBER BEING STRESSED BEYOND SPEC EITHER AT THE TIME OF THE INCIDENT OR SOME TIME PRIOR, THEREBY WEAKENING THE FIBER.
ATRIAL OVERSENSING WAS REPORTED AFTER THE DEVICE WAS IMPLANTED. THE ATRIAL SENSITIVITY IS AT .5 MILLIVOLTS AND THE VENTILATOR OUTPUT IS 5.4 V/0.5M SEC. MODE SWITCHING WAS OBSERVED WITHOUT THE PRESENCE OF ATRIAL ARRHYTHMIAS. ATRIAL SENSE ANNOTATION (DOT) NOTED NEAR VENTRICULAR PACED EVENT AND EVOKED T-WAVE. NO IRRATIC TRACKING WAS OBSERVED WHEN MODE SWITCHING WAS "OFF". FURTHER DESCRIPTION OF THE EVENT IS IN SECTION H.10 OF THIS FORM.
REFERENCE SECTION F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. CONTINUED FROM SECTION B.5 OF THIS FORM: THE PT WAS DISCHARGED ON 8/8 AND IEGM SHOWED NO EVIDENCE OF ATRIAL OVERSENSING. THE EXACT EVENT DATE IS UNKNOWN. ANALYSIS CONCLUDED THAT THE DEVICE APPEARS TO BE WORKING AS DESIGNED AND SPECIFIED.
THE HIGHEST TIDAL VOLUME THE VENTILATOR WOULD DELIVER WAS 600ML.
THE PROBLEM COULD HAVE BEEN CAUSED BY A COMBINATION OF A RESTRICTED THROAT (AS REPORTED BY THE HOSPITAL) AND/OR SOFT TUBING.
WHILE RECEIVING DEVICES INTO STOCK, IT WAS NOTICED THAT THE CATALOG NUMBER INDICATING A STANDARD STEM HAD THE WORD "JUMBO" ON THE LABEL. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE; THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT.
THE HOSP CONTACTED THE LOCAL SALES AGENCY. THE AGENCY CHECKED THEIR STOCK AND FOUND ONE STEM CORRESPONDING IN CATALOG NUMBER AND LOT CODE TO HAVE THE SAME LABELING. IT WAS NOTED THAT "JUMBO" WAS INDICATED ON ONLY ONE OF THE END LABELS. THE STEM LOCATED AT THE HOSP HAS NOT BEEN RETURNED FOR EVAL. THE DEVICE WAS NOT MANUFACTURED IN THE US. EVAL OF THIS DEVICE IS TO BE PERFORMED AT THE MFG FACILITY.
BUR HEAD DISCONNECTED FROM BUR DURING LAMINEACTOMY. THE DR WAS ABLE TO RETRIEVE THE BUR HEAD.
SECTION F10- CODE #2199 & #1073-NOT LABELED. ALL INFO TO COMPLETE SECTIONS A,B,D,E, & F WAS OBTAINED BY CO REGULATORY COMPLIANCE DEPARTMENT.
A BALLOON DEVELOPED A LEAK DURING AN ANTERIOR TIBIAL/PERONEAL PERCUTANEOUS TRANSLUMENAL ANGIOPLASTY VIA A IPSILATERAL APPROACH OF A CALCIFIED LESION. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PT COMPLICATIONS. THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION REVEALED A BURST LOCATED EIGHT MILLIMETERS DISTAL FROM THE PROXIMAL RO MARKER. THE DEVICE SURFACE DISPLAYED CHATTER MARKS. DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH OVERPRESSURIZATION, CHATTER MARKS ON THE BALLOON'S SURFACE. IT WAS INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE.
THE DEVICE IS CURRENTLY PACING AT A RATE OF 20 PPM WITH INTERMITTENT SENSING AND CAPTURE. WHEN THE MAGNET IS APPLIED, THERE IS NO OUTPUT. THE DEVICE WILL BE EXPLANTED.
REFERENCE SECTION F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES.
A REQUEST WAS MADE TO RETURN THE SUSPECT DEVICE FOR EVALUATION. THE CUSTOMER STATED THAT THE LANCET WAS DISCARDED. THEREFORE, NO EVALUATION COULD BE MADE. THE CUSTOMER WAS SENT REPLACEMENT PRODUCT AND WILL CALL BACK IF SHE HAS ANY ADD'L QUESTIONS. THE COMPLAINT IS CONSIDERED CLOSED FOR PURPOSES OF MEDICAL DEVICE REPORTING.
A BALLOON RUPTURED ON THE FIRST INFLATION DURING A HEMODIALYSIS FISTULA PROCEDURE. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE SHAFT OF THE BALLOON WAS CORKSCREWED. MICROSCOPIC EXAMINATION REVEALED TWO PINHOLE LEAKS NOTED AT THE DISTAL RO MARKER AND 3MM PROXIMAL TO THE DISTAL RO MARKER. SCRATCHES WERE NOTED ON THE BALLOON SURFACE. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH OVERPRESSURIZATION, A CORKSCREWED SHAFT UNDER THE BALLOON AS WELL AS CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES ON THE BALLOON SURFACE. THEREFORE, CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE.
A BALLOON DEVELOPED A PIN-HOLE LEAK AT EIGHT ATM DURING THE FIRST INFLATION OF AN ILIAC ANGIOPLASTY. THE LESION WAS CALCIFIED AND A SECOND BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PT COMPLICATIONS. THIS DEVICE WAS DESTROYED AND IS NOT BEING RETURNED TO THE MFR. THEREFORE, NO ENGINEERING EVALUATION WILL BE AVAILABLE. FOLLOW UP REVEALED THIS BALLOON CATHETER WAS USED IN A CALCIFIED LESION WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE PRODUCT, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
RESPIRATORY THERAPIST REPORTED, A STAFF MEMBER OBTAINED A RESUSCITATOR TO RESCUSITATE PT. THE RESUSCITATOR WAS OBSERVED TO HAVE A CRACK ON THE VALVE HOUSING. ANOTHER RESUSCITATOR WAS OBTAINED AND PT RESUSCITATED. NO REPORTED HARM TO PT. EVALUATION DETERMINED CRACK TO ACTUALLY BE A FRACTURE.
A VISUAL EVALUATION DETERMINED THE VALVE HOUSING TO HAVE A FRACTURE (NOT A CRACK AS REPORTED). WHEN TESTED, THE RESUSCITATOR FUNCTIONED PROPERLY. ABLE TO REPRODUCE FRACTURE BY APPLYING EXCESSIVE FORCE TO THE DUAL SWIVEL ELBOW INSERTED INTO THE VALVE HOUSING. THE VALVE HOUSING PORT FAILED (FRACTURED) DUE TO TRANSFER OF EXCESSIVE TORQUE TO VALVE HOUSING PORT. OVER THE PAST THREE YEARS, TWO COMPLAINTS RECEIVED.
THE UF REPORTED TO THE MFR OF THE DEVICE THAT THE DEVICE "SWITCHES ON & OFF BY ITSELF INTERMITTENTLY."
EVAL: THE MONITOR TURNED OFF WITHOUT ALARMING. THE MALFUNCTION WAS FOUND TO BE DUE TO A LOW LEVEL COMPONENT (NON-VOLATITLE RAM) FAILURE. THE MONITOR DISPLAYED. SIGNS OF PHYSICAL ABUSE UPON RECEIPT BY THE MFR.
THE LEAD WAS EXPLANTED ELECTIVELY. FAILURE ANALYSIS INDICATES OUTER INSULATION LACERATION.
RESPIRATORY THERAPIST, REPORTED A STAFF MEMBER OBTAINED A RESUSCITATOR FOR USE DURING A CODE. THE RESUSCITATOR WAS OBSERVED TO HAVE A BROKEN ELBOW. ANOTHER RESUSCITATOR WAS OBTAINED AND PT WAS RESUSCITATED. NO REPORTED HARM TO PT.
THE ELBOW HAS SHARP CORNERS AT THE POINT WHERE THE BREAK OCCURS. MINOR MODIFICATIONS WERE MADE TO THE ELBOW TO ROUND THOSE SHARP CORNERS. COMPARATIVE TESTING CONFIRMED THAT THE ELBOWS WITH THE ROUNDED CORNERS COULD WITHSTAND A GREATER FORCE THAN THOSE WHITH SHARP CORNERS.
ANOTHER MFR'S INTRA-AORTIC BALLOON PUMP WAS ALARMING "VOLUME LOSS." THE BALLOON CATHETER WAS REMOVED, ANOTHER ONE WAS INSERTED AND THE PUMP STOPPED ALARMING. THERE WERE NO PT COMPLICATIONS INVOLVED. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION.
H6. 86(OTHER) - MICROSCOPIC EXAMINATION:THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. SEVERAL KINKS WERE NOTED ALONG THE SHAFT. THE TWO-WAY STOP COCK WAS ATTACHED TO THE INFLATION LUMEN OF THE CATHETER. VISUAL EXAMINATION WITH THE UNAIDED EYE AS WELL AS MICROSCOPIC EXAMINATION DID NOT REVEAL ANY ANOMALIES. THE DEVICE FUNCTIONED AS INTENDED. SINCE NO PROBLEMS WERE NOTED UPON EVALUATION WE DO NOT ATTRIBUTE THIS EVENT TO THE DEVICE. PERHAPS USER TECHNIQUE OR ANCILLARY EQUIPMENT CONTRIBUTED TO THIS EVENT.
THE DEVICE SHOWED NO MAGNET RESPONSE DESPITE NUMEROUS MAGNET POSITIONS. THE DEVICE CANNOT COMMUNICATE WITH THE PROGRAMMER. THIS UNIT IS PART OF THE QUANTUM/SUPRIMA II SAFETY ALERT. THE PT HAS SUFFICIENT INTRINSIC RHYTHM. THE EXACT EVENT DATE IS UNKNOWN.
REFERENCE SECTION F.10 OF THIS FORM OF THE EVENT PROBLEM CODES.
THE WELD ON THE C-ARM WAS CRACKED AND THE UNIT WAS TAKEN OUT OF SVC. APPARENTLY, DURING EVALUAITON, THE WELD FAILED COMPLETEDLY ALLOWING THE C-ARM TO DETACH FROM ITS MOUNTING. NO INJURY WAS REPORTED.
AN INTRA-AORTIC BALLOON PUMP WAS ALARMING "VOLUME LOSS". THE PT WAS TRANSFERRED TO ANOTHER INTRA-AORTIC BALLOON PUMP WITHOUT INCIDENT. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. THE BIO-MED DEPT AT THE USER FACILITY EVALUATED THE BALLOON PUMP. WATER WAS NOTED ON THE BOTTOM OF THE DOME TRAY SUPPORT. ALL HOSES WERE CHECKED AND A TWO HR VOLUME LOSS/GAIN TEST WAS PERFORMED. THE PUMP FUNCTIONED AS INTENDED WITHOUT INCIDENT. A CHECKOUT PROCEDURE WAS PERFORMED AND THE BALLOON PUMP WAS PLACED BACK IN SVC. THE OPERATING MANUAL OUTLINES THE PROCEDURE FOR LOCATING THE POSSIBLE CAUSES FOR A "VOLUME LOSS/BALLOON SLOW" ALARM. MAINTENANCE SCHEDULE OUTLINES ROUTINE MAINTENANCE STEPS WHICH ADDRESS THIS ISSUE.
H6. 86 -  DEVICE WAS EVALUATED BY THE BIO-MED DEPT AT THE USER FACILITY.
THE VASCULAR IMAGING SYSTEM WOULD NOT BE ABLE TO RETRIEVE IMAGES ON AN INTERMITTENT BASED. STUDIES TO DATE HAVE BEEN SUFFICIENT TO MAKE THE MEDICAL DIAGNOSIS.
TUBE HOLDER WAS IN USE 3 DAYS WHEN THE TUBE HOLDER SEPARATED FROM THE FOAM. THE PT EXTUBATED. PT DATA IS NOT AVAILABLE. THE INACTIVE PT, RECOVERING FROM CARDIO-THORACIC SURGERY, HAD AVERAGE ORAL SECRETIONS. THE PT WAS SEDATED. THE ENDOTRACHEAL TUBE HOLDER WAS CLEANED WITH A WIPE USING A CLOTH AND WARM WATER WITH A BABY BATH MIXTURE. THE PT WAS SUCCESSFULLY RE-INTUBATED. THE ENDOTRACHEAL TUBE HOLDER WAS NOT RETURNED FOR EVALUATION.
HOLDER WAS NOT RETURNED FOR EVALUATION; THEREFORE THE CLAIM CANNOT BE SUBSTANTIATED. CO HAS NO INFO TO SUGGEST THAT THE REPORTED EVENT IS OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.
THE DEVICE IS EXHIBITING NO MAGNET RESPONSE. THE PT HAS A GOOD UNDERLYING RHYTHM, THEREFORE, SPIKES ARE NOT OBSERVED. THE DEVICE IS PART OF THE QUANTUM/SUPRIMA II SAFETY ALERT.
REFERENCE SECTION F.10 OF THIS FORM FOR EVENT PROBLEM CODES.
COMPUTERIZED IMAGES WERE UNABLE TO BE RETRIEVED AFTER ACQUISITION FROM THE DIAGNOSTIC X-RAY SYSTEM. THIS HAS HAPPENED ON AN INTERMITTENT BASIS. NO INJURY WAS REPORTED.
DURING A TRANSURETHRAL RESECTION OF THE PROSTATE, A CUTTING LOOP ELECTRODE REPORTEDLY SPARKED AT THE CONNECTION BETWEEN IT AND THE ELECTRICAL HANDPIECE. NO INJURIES OCCURRED. ANOTHER CUTTING LOOP WAS INSERTED AND THE CASE PROCEEDED WITH NO FURTHER PROBLEMS.
THE DATA IN SECTION F WAS FILLED IN BY THIS MFR. THE DEVICE WAS VISUALLY AND ELECTRICALLY CHECKED. THERE WERE BENDS IN THE SHAFT AND IN THE WIRE LOOP, APPARENTLY DUE TO SHIPPING. NO ELECTRICAL SHORT WAS FOUND. IT IS BELIEVED USER HAD MOISTURE RETAINED IN THE CONTACT RECEPTACLE OF THE HANDPIECE.
AN INTRA-AORTIC BALLOON PUMP WAS ALARMING "GAS LEAKAGE" AS SOON AS THE BALLOON CATHETER WAS INSERTED. ANOTHER INTRA-AORTIC BALLOON CATHETER WAS PLACED SUCCESSFULLY. THERE WERE NO PT COMPLICATIONS INVOLVED. THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. ALL CATHETERS ARE 100% LEAK TESTED DURING PRODUCTION. CO BELIEVES THIS PROBLEM OCCURRED EXTERNAL TO THE MFG PROCESS. HOWEVER, WITHOUT EVALUATING THE DEVICE CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
H6. 86(OTHER) - MICROSCOPIC EXAMINATION: THE DEVICE WAS RECEIVED, EVALUATED, AND RETAINED BY THIS MFR. THE DEVICE WAS RECEIVED WITH A 30CC ADAPTER. NO EVIDENCE OF CONTAMINATION WAS NOTED. NO ABRASIONS OR LEAKS WERE NOTED ON THE BALLOON UPON EVALUATION. MICROSCOPIC EXAMINATION CONFIRMED THERE WERE NO ANOMALIES WITH THE DEVICE. SINCE NO PROBLEMS WERE NOTED UPON EVALUATION, WE DO NOT ATTRIBUTE THIS EVENT TO THE DEVICE. PERHAPS USER TECHNIQUE OR ANCILLARY EQUIPMENT CONTRIBUTED TO THIS EVENT.
WHILE ATTEMPTING TO DEPLOY THE COIL, IT WAS PULLED BACK INTO THE CATHETER. AS IT WAS PULLED BACK IT DETACHED FROM THE WIRE. THE REPORT STATES THAT THERE WAS NO RESISTANCE FELT WHILE PULLING BACK THE COIL.
THE ANALYSIS FOUND THE MAIN COIL BROKE DISTAL OF THE MAIN SOLDER JOINT. THE MAIN COIL HAS BEEN STRETCHED, PRIMARILY IN THE PROXIMAL END OF THE COIL. OTHER THAN THE STRETCHED SHAPE, THE DEVICE MET CO'S SPECS. FROM THE CONDITION OF THE DEVICE, THE BREAKING OF THE MAIN COIL HAPPENED IN TENSION DUE TO EXCESSIVE PULLING OF THE DEVICE DURING THE PROCEDURE. THIS INFO IS BASED ON INFO SUPPLIED TO CO WITHOUT CO'S INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT.
DEVICE USER OBTAINED AN INCORRECT CALIBRATION CODE. THE INCORRECT CODE, IF USED TO PERFORM AN ASSAY COULD RESULT IN HIGHER THAN EXPECTED RESULTS. THE USER NEVER RECALIBRATED THE DEVICE. PROPER CALIBRATION IS COVERED IN THE USER MANUAL.
RESULTS POTENTIALLY OBTAINED WITH INCORRECT CALIBRATION CODE PLOTTED ON A CLARKE ERROR GRID. RECALIBRATION OF SENSOR PERFORMED SUCCESSFULLY BY USER.
THE PT UNDERWENT SURGERY TO HAVE HER BREAST IMPLANTS REMOVED; ELECTROCAUTERY WAS USED. UPON INQUIRE OF THE PACER, THE BACKUP RESET SCREEN WAS DISPLAYED. A RESET WAS PERFORMED; HOWEVER, IT WAS UNSUCCESSFUL, THE UNIT REMAINED IN BACKUP. A SECOND RESET WAS DONE, SUCCESSFULLY. THE TELEMETERED CELL VOLTAGE WAS 2.6 VOLTS. DUE TO QUESTIONABLE PERFORMANCE OF THE DEVICE (IE BACKUP REVERSION) REPLACEMENT WAS RECOMMENDED.
THE PT WAS INVOLVED IN A CAR ACCIDENT ON 11/3/91 AND SUFFERED BILATERAL FEMORAL FRACTURES. THE RIGHT LEG HEALED WHILE THE PT HAD CONTINUED PAIN THE LEFT LEG. THE PT SAW ANOTHER DR AND ALLEGES THAT THE UNSPECIFIED PLATE AND SCREWS WERE REMOVED DUE TO BENDING OF THE PLATE AND BREAKAGE OF ONE SCREW.
INFO FROM THE USER FACILITY INDICATES THAT THE DEVICE WAS NOT MANUFACTURED BY CO.
THE CEMENT HARDENED PREMATURELY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
EVAL RESULTS SUGGEST THAT THE CAUSE OF THIS EVENT WAS ATTRIBUTED TO SOME FACTOR EXTERNAL TO OUR PRODUCT. THE RESULTS OF TESTING SIMILAR BATCH LOTS OF PRODUCT INDICATED NO MIXING ANOMALIES. IT IS BELIEVED THAT THE ENVIRONMENTAL CONDITIONS OF THE OR MAY HAVE AFFECTED THE SET-UP TIME OF THE CEMENT.
THE CEMENT WAS LOADED INTO THE CEMENT GUN AND HARDENED BEFORE EXTRUSION COULD BEGIN. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
TESTS PRFORMED BY DEVICE USER OUTSIDE MFG RECOMMENDATIONS (+10%). IMPRECISE READING COULD CAUSE THE USER TO MISTREAT THEMSELVES CLINICALLY AND COULD HAVE ADVERSE EFFECTS.
THE PROGRAMMED PACING MODE CHANGED BETWEEN FOLLOW-UP IN FEBRUARY 96 AND AUGUST '96. WHEN THE PT WAS DISCHARGED IN FEBRUARY, THE DEVICE WAS PROGRAMMED TO DDDR MODE. THE SUBSEQUENT FOLLOW-UP IN AUGUST SHOWED THAT THE PACING MODE WAS VVIR AT A RATE OF 60 PPM. REVIEW OF THE ITP STRIPS SHOWED NO PROGRAMMING BETWEEN FOLLOW-UPS. THE PT DENIED SURGERY OR EXPOSURE TO ENVIROMENTAL HAZARDS. THE PT HAD ATRIAL FIB. NO OTHER RECORD OF WHAT WENT ON DURING THE FEBRUARY FOLLOW.
CUSTOMER HAS REPORTED ANOMOLOUS READINGS. NO REPORT OF INJURY HAS BEEN REC'D.
THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF CO THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY.
THE PHYSICIAN PERFORMED A STONE REMOVAL FROM THE BILIARY DUCT WITH A HARD WIRE BASKET. DURING THE PROCEDURE, THE BASKET PORTION OF THE DEVICE DETACHED. THE BASKET WAS IMMEDIATELY RETRIEVED WITH A SNARE SUCCESSFULLY. NO FURTHER COMPLICATIONS OCCURRED AND THE PT IS IN SATISFACTORY CONDITION.
THIS REPORT IS BASED ENTIRELY ON UNCONFIRMED INFO SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENDED TO BE AN ADMISSION THAT ANY WILSON-COOK DEVICE (I) IS DEFECTIVE OR MALFUNCTIONED OR (II) CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. WE DO NOT BELIEVE THAT THIS REPORTED INCIDENT IS LIKELY TO REOCCUR. THE BASKET WAS RETURNED IN A STATE OF DISREPAIR AND EXHIBITED THE FOLLOWING CHARACTERISTICS. THE BASKET PORTION OF THE DEVICE IS DETACHED FROM THE DRIVE CABLE. THE HANDLE CANNULA IS BENT AND HAS BEEN TAKEN APART AND REPOSITIONED BY THE USER. AN INNER PORTION OF THE THREE RING HANDLE IS CRACKED AND SEPARATED. TWO KINKS WERE NOTED IN THE DISTAL PORTION OF THE BASKET SHEATH. DETACHMENT OF THE BASKET OCCURRED WHEN THE SOLDER JOINT BECAME WEAKENED FROM EXCESSIVE USE, IMPROPER CARE AND OR AN INSUFFICIENT BOND. AN IMPROVEMENT TO THE MWB5 BASKET LINE WAS IMPLEMENTED 8/95. THE JOINT ATTACHING THE BASKET TO THE DRIVE CABLE WAS STRENGTHENED. NO COMPLAINTS OF DETACHMENT HAVE BEEN RECORDED ON MWB5'S THAT WERE MFG AFTER 8/95.
INVESTIGATION OCCURRED. DR CITES SINUS INVOLVEMENT AND PT IS ON STEROIDS FOR CHEMOTHERAPY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
REFERENCE SECTION F.10 OF THE FORM FOR THE EVENT PROBLEM CODES. THE IMPLANT DATE IS UNKNOWN. THIS IS THE SAME 1640319-1996-00301.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. POSSBILE POST SURGICAL LOADING OF IMPLANT. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE HAD AN INTERMITTENT LOSS OF SENSING.
REF. F10 OF THIS FORM FOR THE EVENT PROBLEM CODES.
THE VENTILATOR WAS ALARMING LOW BATTERY AND COULD NOT BE USED.
THE 3RD PARTY SVC REP, STATED THAT HE INSPECTED THIS VENTILATOR AND FOUND A LOOSE CONNECTION ON THE SENSOR PCB AT J10 OR P1 WITH 59, 60, AND 61. THE LOOSE WIRE CAUSED THE BATTERY TO ONLY CHARGE TO ABOUT 10% OF CAPACITY. MFG AND QC NOTIFIED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE EL314 JAWS WERE LOOSE AND DROPPING CLIPS. THERE WAS NO CONSEQUENCE TO THE PT.
THE SWITCH REMAINED IN THE "ON" POSITION. THE UNIT HAS NOT BEEN RETURNED    TO BE INSPECTED AND MAY NOT BE. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY ADDRESSED IN LABELING NO. FREQUENCY GREATER THAN USUAL YES. SEVERITY ADDRESSED IN LABELING YES. SEVENTY GREATER THAN LABELING NO.
REPORT STATES BALLOON NON-CONCENTRIC-PRETEST. REPORT ALSO STATES PT HAS USED PRODUCT SINCE 1993 AND THIS IS HIS FIRST COMPLAINT. THE DEVICE WAS NOT USED IN OR ON PT.
THE SWITCH REMAINED IN THE "ON" POSITION. CO'S INSPECTION REVEALED THE SPRING HAD BROKEN. THE CASE HAS BEEN CHANGED TO ELIMINATE THIS PROBLEM. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED.
FREQUENCY ADDRESSED IN LABELING NO, FREQUENCY ADDRESSED IN LABELING NO, SEVERITY ADDRESSED IN LABELING NO, SEVERITY GREATER THAN LABELING NO.
THE DEVICE HAD AN INTERMITTENT LOSS OF CAPTURE.
REPORT STATES  BALLOON NON-CONCENTRIC-PRETEST. REORT ALSO STATES PT HAS USED PRODUCT SINCE 1993 AND THIS IS HIS FIRST COMPLAINT. THE DEVICE WAS NOT USED IN OR ON PT.
RR INTERVALS EXCEEDING LOWER LIMIT. TRANSMITTER FAILED BEFORE MAGNET COULD BE USED. PACER FAILURE CAN NOT BE EXCLUDED.
THE SWITCH REMAINED IN THE "ON" POSITION. CO'S INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROX 1967 TO 6/21/90, CO USED AN UNDERWRITER'S LABORATORIES LISTED SWITCH MANUFACTURED BY A REPUTABLE FIRM. THE SWITCH WAS A MOMENTARY TYPE SWITCH WITH A SPRING LOADED LEVER WHICH REQUIRED BEING HELD IN THE "ON" POSITION TO MAKE CONTACT. SOMETIMES A USER WOULD NOT FULLY ENGAGE THE LEVER, ALLOWING THE CONTACTS TO REMAIN SLIGHTLY OPEN WHICH COULD INDUCE ARCING. WHEN CONSISTENTLY HELD IN THIS WAY, CARBON BUILD-UP FROM THE ARCING COULD REACH OPPOSITE POLES CAUSING THE SWITCH TO EMIT A SMALL AMOUNT OF SMOKE. CO'S FIRST SOLUTION WAS TO CHANGE THE CONTACT MATERIAL AND THE BODY OF THE SWITCH. THIS REDUCED THE ARCING OF THE CONTACTS AND THE CARBON TRACKING OF THE SWITCH BODY. ALTHOUGH THE SITUATION WAS IMPROVED, THE OCCASIONAL RELEASE OF A PUFF OF SMOKE WAS POSSIBLE. ON 6/21/90, CO BEGAN USING A SNAP ACTION SWITCH. WHICH DOES NOT ALLOW THE CONTACTS TO BE HELD IN A SLIGHTLY OPEN POSITION. THIS EVENT IS NOT REPORTABLE UNDER 21CFR803 BECAUSE SIMILAR EVENTS WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO BE COMPLIANT WITH REGULATORY LETTER 90-DT-12. REMEDIAL ACTION HAS BEEN ACCOMPLISHED.
FREQUENCY ADDRESSED IN LABELING NO. FREQUENCY GREATER THAN USUAL YES. SEVERITY ADDRESSED IIN LABELING NO. SEVERITY GREATER THAN LABELING NO.
RELAY USED AS REPLACEMENT. WHEN PHYSICIAN ATTEMPTED TO INSERT VENTRICULAR LEAD IT WOULD NOT GO IN. DEVICE TO BE RETURNED.
THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING, ENVIROMENTAL STRESS TESTING, AND CONNECTOR DIMENSIONAL ANALYSIS. NORMAL PACER OPERATION WAS OBSERVED. THE DEVICE IS OPERATING WITHIN NEW PACER SPECS.
REPORT STATES BALLOON NON-CONCENTRIC - PRETEST. REORT ALSO STATES PT HAS USED PRODUCT SINCE 1993 AND THIS IS HIS FIRST COMPLAINT. THE DEVICE WAS NOT USED ON OR ON PT.
REPORT STATES BALLOON NON-CONCENTRI- PRETEST. REPORT ALSO STATES PT HAS USED PRODUCT SINCE 1993 AND THIS IS HIS FIRST COMPLAINT. THE DEVICE WAS NOT USED IN OR ON PT.
REPORT ALLEGES THE BALLOON DOES'T INFLATE EVENLY ON PRETEST. DATE INCIDENT OCCURRED WAS 7/23/96. THE DEVICE WAS NOT USED ON A PT. UNABLE TO DETERMINE LOT NUMBER WITH CATALOG NUMBER PROVIDED.
BZ X-TUBE ASSM 16" X 16" PNTD. DEALER CLAIMS THE X-TUBE IS BROKEN AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFD PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
X-TUBE ASSAM 20" X 16". DEALER CLAIMS X-TUBE BROKE AT A WELD.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
X-TUBE ASSM 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT RELFECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
X-TUBE ASSM 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE UPPER WELD.
INVESTIGATION CONDUCTED. CAUSE OF FAILURE UNKNOWN. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
X-TUBE ASSM 18" X 17". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CRF PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT RELFECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. DR CITES CAUSE OF FAILURE AS INFECTION. PT HAS DIMINISHED ORAL HYGIENE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY ANS SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
X-TUBE ASSM 17" X 16". DEALER CLAIMS X-TUBE BROKE WHERE THE TWO COME TOGETHER.
A MES (MEDICAL EQUIPMENT SERVICE) TECH EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR: N. TRAINING REQUIRED: N.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY/QUANTITY INSUFFICIENT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDEED USUAL FOR THIS TYPE OF DEVICE.
X-TUBE ASSM 18" X 16". DEALER CLAIMS X-BRACE IS BROKEN ON THE LEFT SIDE OF BOLT HOLE.
INVESTIGATION CONDUCTED. DR CITES INFECTION AND POSSIBLE POST SURGICAL LOADING AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
X-TUBE ASSM 17" X 15". DEALER CLAIMS THE CROSS FRAME IS BROKEN IN THE CENTER OF THE HINGE.
X-TUBE ASSM 20" X 16". DEALER CLAIMS THE X-TUBE IS BROKEN AT THE CENTER BOLT.
FREQUENCY ADDRESSED IN LABELING NO. FREQUENCY GREATER THAN USUAL IS YES. SEVERITY ADDRESSED IN LABELING YES. SEVERITY GREATER THAN LABELING NO.
DURING A DIALYSIS TREATMENT, THE FACILITY'S STAFF NOTICED THAT THE BLOOD PUMP HAD STOPPED PULLING BLOOD. THE TREATMENT WAS DISCONTINUED AND BLOOD LOSS WAS ESTIMATED AT 250CC. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
TEST PROCEDURE FOLLOWED: QARA 146, REVISION: F. MFG SPECIFICATIONS TESTED TO (IF NOT CLEARLY ESTABLISHED IN TEST PROCEDURE): VISUAL. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT BOTH OF THE SPRINGS ON THE ROTOR WERE BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT ONE OF THE SPRINGS WERE BROKE IN THREE PIECES, THE OTHER ONE WAS BROKEN IN TWO PIECES. THE AFFECTED COMPONENT WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, A DETERMINATION AS TO ITS FAILURE MODE COULD NOT BE PERFORMED. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960018.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY/QUANTITY INSUFFICIENT AS CAUSE FOR FAILURE. PT IS A SMOKER, CONSUMES ALCOHOL AND HAS DIMINISHED ORAL HYGIENE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT. VISUAL EXAMINATION: THE BALLOON EXHIBITED A 1CM LONG, AXIALLY-DIRECTED TEAR, 2 CM PROXIMAL TO THE DISTAL TIP. TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE BALLOON. MICROSCOPIC EXAMINATION: FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED NO EVIDENCE OF EXTERNAL OR INTERNAL SURFACE ABRASIONS. THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED.
X-TUBE ASSM 18" X 16". DEALER CLAIMS THE X-TUBE IS BROKEN AT THE BOLT.
NO DEATH OR SERIOUS INJURY OCCURRED. PRODUCT #103-8575, LOT #661 HAS BEEN TESTED AND NO DEFECTS FOUND. NO ADD'L INFO WILL BE SUBMITTED.
X-TUBE ASSEM 18" X 16" HINGE BR. DEALER CLAIMS THE X-TUBE IS BROKEN AT BOLT THAT HOLDS THE TWO TOGETHER.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE SURGEON WAS LIGATING THE CYSTIC ARTERY. A CLIP FROM THE ER320 WAS APPLIED TO THE CYSTIC ARTERY AND THE SURGEON NOTED A GAP IN THE CLIP. THE SURGEON DIVIDED THE CYSTIC ARTERY WHICH RESULTED IN BLEEDING. AN ATTEMPT WAS MADE TO CLIP THE ARTERY LAPAROSCOPICALLY. THE CASE WAS CONVERTED TO OPEN. THE PT LOST 500CC'S OF BLOOD. THE CLIP APPLIER WAS DISPOSED OF. TWO CLIPS ARE BEING SENT IN FOR ANALYSIS.
H6: CODE 81(OTHER)- ONE CLIP RETURNED FOR EVALUATION, DEVICE NOT RETURNED. CODE: 100(OTHER)-PEAR SHAPED CLIP. A1,2,3,4;B6,7,D10-INFORMATION NOT PROVIDED BY USER FACILITY. 8/30/96 1200 ATTEMPTED TO CALL CONTACT PERSON. THERE WAS NO ANSWER. CALLED OR AND WAS TOLD CONTACT WAS ON VACATION. BAH. D5,6;H4-INFORMATION NOT AVAILABLE.
X-TUBE ASSM 19" X 18". DEALER CLAIMS THE X-TUBE IS BUSTED AT THE BOLT.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED BECAUSE THE PT WAS UNABLE TO INFLATE THE DEVICE.
THE SWITCH EMITTED SMOKE AND THE USER REC'D A MINOR SHOCK. CO'S INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROX 1967 TO JUNE 21, 1990, CO USED A SWITCH MANUFACTURED BY A REPUTABLE FIRM. THE SWITCH WAS A MOMENTARY TYPE SWITCH WITH A SPRING LOADED LEVER WHICH REQUIRED BEING HELD IN THE "ON" POSITION TO MAKE CONTACT. SOMETIMES A USER WOULD NOT FULLY ENGAGE THE LEVER, ALLOWING THE CONTACTS TO REMAIN SLIGHTLY OPEN WHICH COULD INDUCE ARCING. WHEN CONSISTENTLY HELD IN THIS WAY, CARBON BUILD-UP FROM THE ARCING COULD REACH OPPOSITE POLES CAUSING THE SWITCH TO EMIT A SMALL AMOUNT OF SMOKE. CO'S FIRST SOLUTION WAS TO CHANGE THE CONTACT MATERIAL AND THE BODY OF THE SWITCH BODY. ALTHOUGH THE SITUATION WAS IMPROVED, THE OCCASIONAL RELEASE OF A PUFF OF SMOKE WAS POSSIBLE. ON 6/21/90, CO BEGAN USING A SNAP ACTION SWITCH WHICH. DOES NOT ALLOW THE CONTACTS TO BE HELD IN A SLIGHTLY OPEN POSITION. THIS EVENT IS NOT REPORTABLE UNDER 21CFR803 BECAUSE SIMILAR EVENTS WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO BE COMPLIANT WITH REGULATORY LETTER 90-DT-12. REMEDIAL ACTION HAS BEEN ACCOMPLISHED.
FREQUENCY IS ADDRESSED IN LABELING. FREQUENCY IS NOT GREATER MAN LABELED. SEVERITY IS ADDRESSED IN LABELING. SEVERITY IS NOT GREATER THAN LABELING.
A BLOOD STAIN WAS FOUND IN TWO NEWLY OPENED NEEDLES PRIOR TO USE BY THE CLINICAL LAB TECH ON TWO SEPARATE DAYS. A REDDISH STAIN WAS IDENTIFIED ON THE SLEEVES OF THE NEEDLE PORTION THAT IS USED TO PENETRATE THE RUBBER CAP OF THE BLOOD COLLECTION TUBE. A SAMPLE OF THIS MATERIAL WAS PREPARED ON A NORMAL SALINE WETMOUNT SLIDE AND RED BLOOD CELLS WERE IDENTIFIED.
ACTUAL SAMPLES WERE NOT RETURNED FOR EVALUATION. 910 UNOPNED SAMPLES WERE RETURNED FROM THE COMPLAINT LOT. ALL SAMPLES WERE EVALUATED VISUALLY. FIVE PIECES WERE FOUND TO HAVE FOREIGN MATERIAL. SPECIFIC IDENTIFICATION COULD NOT BE MADE, BUT IT WAS DETERMINED NONE WERE BLOOD. CUSTOMER REPORTED SEEING "LIQUID" BLOOD. PRODUCT WAS 2 1/2 YEARS OLD, IMPOSSIBLE FOR LIQUID NOT TO DRY IN THAT TIME IF IT CAME FROM MANUFACTURE. NEEDLE WAS NOTED TO HAVE A PERFORATION AT THE END INDICATING PROBABLE USE. LOT HISTORY REVIEW INDICATED NO FINDINGS OF BLOOD OR SIMILAR CONTAMINATE. IF USING PROPER OSHA RECOMMENDED PROCEDURES, NEEDLES WOULD BE DISPOSED OF IMMEDIATELY AFTER USE. RECAPPING WOULD NOT BE ALLOWED. NO PHLEBOTOMY TEST RECOMMENDS RECAPPING OR RESHEATING. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVID AND GECK TO BE COMPLETE AND ACCURATE. FURTHEMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAD MALFUNCTIONED.
IMPLANT PLACED 9/27/95. IT FAILED TO INTEGRATE AND WAS REMOVED.
RETURNED IMPLANT WAS EVALUATED AND MEASURED WITH A MICROMETER. IT MET SPECIFICATIONS. NO PT MEDICAL HISTORY WAS RECEIVED. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE CAN BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
AT IMPLANT NOTED THAT A "THICKENED AREA" NEAR THE PROXIMAL END "ABOUT WHERE YOU WOULD EXPECT TO SEE THE SUTURE SLEEVE" WAS NOT ABLE TO BE MOVED. PHYSICIAN QUESTIONED WHETHER DESIGN CHANGED. HE UTILIZED ANOTHER SUTURE SLEEVE AND THE LEAD WAS IMPLANTED.
THE DESIGN HAS NOT CHANGED. THE DEVICE WOULD HAVE TO BE RETURNED TO BE ANALYZED. IT WAS IMPLANTED.
IMPLANT PLACED 3/21/96. IT FAILED TO INTEGRATE AND WAS REMOVED 8/26/96.
THE RETURNED IMPLANT WAS CLEAN AND MET SPECIFICATIONS. PT'S MEDICAL HISTORY WAS NOT RECEIVED. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
X-TUBE ASSM 17" X 18". DEALER CLAIMS THE X-TUBE ASSM IS BROKEN AT THE CENTER CROSS TUBE BOLT.
HIGH STRESS FACTOR AT CENTER AND NEEDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT RELFECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PLAINTIFF ALLEGES SUFFERING AND WILL SUFFER GREAT PAIN OF BODY AND ANGUISH OF MIND, REDUCED EARNING CAPACITY.
THE SWITCH EMITTED SPARKS. CO INSPECTION REVEALED A BREAK IN THE LINE CORD AT THE STRAIN RELIEF. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS ADDED A CAUTION TO THE LABELLING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY IS ADDRESSED IN LABELING. FREQUENCY IS NOT GREATER THAN LABELED. SEVERITY IS ADDRESSED IS LABELING. SEVERITY IS NOT GREATER THAN LABELING.
REACTION TO LATEX GLOVES ON MORE THAN ONE OCCASION. EVENT ON 6/27/96 REQUIRED TREATMENT IN ER. RASH WITH SEVERE ITCHING FOLLOWING THE WEARING OF LATEX GLOVES. RASH WAS ON HANDS, ARMS, AND ABDOMEN, FACIAL FLUSHING, EDEMA OF HANDS, AND DIFFICULTY BREATHING WAS ALSO EXPERIENCED.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE PRODUCT IDENTIFICATION OR LOT NUMBER INFO. SEVERAL ATTEMPTS WERE MADE TO OBTAIN THIS INFO, HOWEVER, THE RREPORTER COULD NOT IDENTIFY WHICH OF THE THREE GLOVES THE EMPLOYEE WAS WEARING CAUSED THE REACTION. THE REPORTER STATED IT COULD HAVE BEEN FROM ANYONE OF THE THREE OR A COMBINATION OF ALL THREE.
OR AXLE W/NUT. DEALER CLAIMS THE QUICK RELEASE AXLE BROKE WHILE TYRING TO TAKE THE WHEEL OFF, THE AXLE JUST FELL APART.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PHYSICIAN COULD NOT INSERT VENTRICULAR LEAD AT TIME OF A GENERATOR REPLACEMENT. LEAD WOULD NOT GO INTO HEADER ALL THE WAY. NEW GENERATOR USED WITHOUT A PROBLEM. DEVICE TO BE RETURNED.
PLAINTIFF ALLEGES AS  A DIRECT AND PROXIMATE RESULT OF BEING CNTINUOUSLY EXPOSED TO THE LATEX GLOVES DEVELOPED SEVERAL ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLRATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE AN PRODUCT IDENTIFICATION OR LOT NUMBER INFO. LITIGATION PENDING, NO CUSTOMER  CONTACT ALLOWED.
PLAINTIFF ALLEGES AS A DIRECT AND PROXIMATE RESULT OF BEING CONTINUOUSLY EXPOSED TO THE LATEX GLOVES DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE  SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES.
THE SWITCH EMITTED SPARKS AND SMOKE. CO'S INSPECTION REVEALED A BREAK IN THE LINE CORD AT THE STRAIN RELIEF. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO ADDED A CAUTION TO THE LABELLING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
RESIDENT WAS FOUND BY NURSE AIDE CERTIFIED (NAC) AND REPORTED TO RN. HE WAS NOTED TO BE ON HIS LEFT SIDE WITH BODY WEDGED BETWEEN MATTRESS AND SIDE RAIL, WHICH WAS UP AND LOCKED. RESIDENT'S LEFT ARM WAS INSERTED THROUGH VERTICLE SIDE RAIL, HEAD ALSO THROUGH VERTICLE SIDE RAIL IN A DEPENDENT POSITION; SO AS TO PUT DIRECT PRESSURE ON THE RESIDENT'S LARYNX. EXTRICATED RESIDENT WITH ASSISTANCE OF 4 PEOPLE. HE WAS NON-RESPONSIVE, 0 MOVEMENT, 0 RESPIRATIONS, EYES OPEN WITH PUPILS FIXED AND DILATED, TONGUE PROTRUDING, LIPS BLUE, 0 HEART RATE. ATTEMPTS TO VENTILATE UNSUCCESSFUL. MEDICAL EXAMINER WAS NOTIFIED VIA TELEPHONE AND REMOVED THE BODY.
PLAINTIFF ALLEGES AS A DIRECT AND PROXIMATE RESULT OF BEING CONTINUOUSLY EXPOSED TO THE LATEX GLOVES DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES.
A TOTAL LOSS OF VENTRICULAR SENSING IS DEMONSTRATED.
PT COMPLAINED OF NOT FEELING WELL DURING TREATMENT, BACK ACHE, BODY ACHE. TREATMENT TERMINATED 30 MINS EARLY. CONTINUES TO FEEL POORLY AT HOME, TAKEN TO HOSP, DIAGNOSIS HEMOLYSIS. TRANSFERED TO ICU. DATE OF DEATH 9/24/96. DURING TREATMENT, CHARGE NURSE NOTED KINK IN ARTERIAL LINE. KINK STRAIGHTENED AND TREATMENT CONTINUED.
INTERMITTENT VENTRICULAR OVERSENSING AND A LOSS OF ATRIAL CAPTURE WERE OBSERVED.
THE CORD EMITTED SPARKS. CO'S INSPECTION REVEALED THE ELECTRICAL CORD WAS BROKEN AT THE STRAIN RELIEF. NO DEATHS OR INJURIES WERE REPORTED. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO ADDED A CAUTION TO THE LABELLING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FOLLOWING BALLOON DILATATION OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY, AN ATTEMPT WAS MADE TO IMPLANT A 17MM STENT. THE STENT COULD NOT BE ADVANCED TO THE APPROPRIATE POSITION. WITH ATTEMPTS TO ADVANCE THE STENT, IT LOOSENED FROM ITS POSITON OVER THE BALLOON. ALL ATTEMPTS TO RETRIEVE THE STENT WERE UNSUCCESSFUL. THE PT SUBSEQUENTLY WENT INTO CARDIAC ARREST AND RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL.
USER ERROR. DURING CPR CRITIQUE RN NOTICED THAT THE PRINTED STRIP FROM THE EKG RECORDING WAS MARKED "PADDLES" RATHER THAN "LEADS." DURING CODE CPR THIS WAS NOT NOTICED, THUS NEVER HAD AN ACCURATE READING OF HEART ACTIVITY. SUGGESTION: POSSIBLE DESIGN PROBLEM/OPPORTUNITY FOR IMPROVEMENT.
PLAINTIFF ALLEGES AS A DIRECT AND PROXIMATE RESULT OF BEING CONTINUOUSLY EXPOSED TO THE LATEX GLOVES, DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLRATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTED DID NOT PROVIDE ANY PRODUCT IDENTIFICATION OR LOT NUMBER INFO. LITIGATION PENDING, NO CUSTOMER CONTACT ALLOWED.
510K #950928. 1 PERSON. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
PLAINTIFF ALLEGES AS A DIRECT AND PROXIMATE RESULT OF BEING CONTINUOUSLY EXPOSED TO THE LATEX GLOVES, DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES.
THE CORD EMITTED SPARKS. CO'S INSPECTION REVEALED THE ELECTRICAL CORD WAS BROKEN AT THE STRAIN RELIEF. NO DEATHS OR INJURIES WERE REPORTED. THE USED OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS  ADDED A CAUTION TO THE LABELLING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY IS ADDRESSED IN LABELING. FREQUENCY IS NOT GREATER THAN LABELED. SEVERITY IS ADDRESSED IN LABELING. SEVERITY IS NOT GREATER THAN LABELING.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
AN INTERMITTENT LOSS OF VENTRICULAR CAPTURE IS DEMONSTRATED.
THE USER REC'D AN ELECTRICAL SHOCK. THE UNIT HAS NOT BEEN RETURNED TO CO FOR INSPECTION AND MAY NOT BE. NO DEATHS OR INJURIES WERE REPORTED.
NO OUTPUT WITH AN INTRINSIC RATE OF 30 BPM. NO OUTPUT WITH MAGNET WITH NO TELEMETRY. TWO MONTHS AGO AT THE LAST FOLLOW-UP THE DEVICE EXHIBITED BEGINNING OF SERVICE (BOS) BEHAVIOR.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE PRODUCT IDENTIFICATION OR LOT NUMBER INFO. LITIGATION PENDING, NO CUSTOMER CONTACT ALLOWED.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE  PRODUCT IDENTIFICATION OR LOT NUMBER INFO. LITIGATION PENDING, CUSTOMER CONTACT NOT ALLOWED.
AFTER FOUR HOURS OF MONITORING THE TEMPERATURE READING WENT TO ZERO. NO REPORT OF INJURY HAS BEEN REC'D.
THE LEAD WAS REMOVED FROM AN OLD 284-05 PACER, AND CONNECTED TO A NEW 284-05. WHEN THE LEAD IMPEDANCE WAS CHECKED IT WAS 178 OHMS. REP SAYS THAT THE LEAD PIN DIDN'T FIT APPROPRIATELY. HE SAYS THAT HE HAS THIS WITH ANOTHER CO'S) LEAD. A NEW LEAD WAS IMPLANTED AND WORKS FINE.
THIS REPORT IS BEING SUBMITTED TO CORRECT THE INITIAL REPORT. THE CORRECT DATA IS IN SECTIONS D.6 (SERIAL #), D.7, AND H.4.
WITHOUT MAGNET: SURFACE ECG SHOWS ATRIAL AND VENTRICULAR PACING AT THE LOWER RATE WITH ATRIAL CAPTURE AND VENTRICULAR FUSION. WITH MAGNET: NO OUTPUT FROM THE PACER AND AN INTRINSIC RATE OF 43 WERE OBSERVED. SUSPECT LEAD PROBLEM.
REPORT RECEIVED OF SUSPECTED J-RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
PRIOR TO USING THE DEVICE THE SENSOR BECAME. "KINKED" AND COULD NOT BE USED. ON INVESTIGATION OF THIS ISSUE BY THE MFR, IT WAS IDENTIFIED THAT THE SENSOR HAD BEEN DAMAGED IN A WAY CONSISTENT WITH THE USER NOT HANDLING THE DEVICE IN ACCORDANCE WITH LABELLED INSTRUCTIONS. THE PROBLEM WAS CONSIDERED TO BE USER ERROR.
THE PROBLEM AS REPORTED 2ND JULY WAS CONSIDERED NON REPORTIABLE. AFTER THE IN-HOUSE INVESTIGATION IDENTIFIED USER DAMAGE TO THE OUTER COVERING OF THE SENSOR AND MDR WAS CONSIDERED APPROPRIATE. THE INVESTIGATION RESULTS WERE AVAILABLE 5TH AUGUST 96.
IMPLANT FAILED TO INTEGRATE, DR ELECTED TO REMOVE IT.
PACEMAKER PROGRAMMED TO VVI + HYSTERESIS, WITH SEARCH CYCLES SET TO THREE. INQUIRE CONFIRMED THESE SETTINGS. HOWEVER, ITP SHOWS SEARCH CYCLES AS OFF. SEE CS FOR PROGRAMMER STRIPS.
THE PROGRAMMER DOES NOT UPDATE THE DISPLAYED HYSTERSIS VALVE ON ITP. NORMAL INQUIRE DOES DISPLAY CORRECTLY. THE PROGRAMMED VALUES ARE CORRECT AND THIS BEHAVIOR ONLY AFFECTS THE PROGRAMMER DISPLAY. THIS HAS BEEN FIXED IN A LATER VERSION OF THE RX5000.
PT UNDERGOING A SUPRACLAVICULAR BLOCK WHEN NEEDLE BROKE. EMBEDDED DEEP BEHIND CLAVICLE. PHYSICIANS UNABLE TO RETRIEVE BROKEN PORTION.
NO PRODUCT WAS RETURNED FOR EVALUATION. NO LOT NUMBER OR REORDER NUMBER INFO WAS PROVIDED. NO RESPONSE WAS FORTHCOMING TO REQUESTS FOR INFO AND/OR SAMPLES, THEREFORE IT IS IMPOSSIBLE TO PERSUE THIS REPORT ANY FURTHER. CO WILL REOPEN THE COMPLAINT SHOULD ANY ADDITIONAL INFO BE RECEIVED FROM THE COMPLAINANT. REFERENCE MFR. COMPLAINT # D96-8-16-144. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
CUSTOMER HAS REPORTED ANOMALOUS READINGS. NO REPORT OF INJURY HAS BEEN REC'D.
THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COPY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF BIOMEDICAL SENSOR LTD THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, AS WAS CAUSALLY RELATED TO ANY DEATH OR INJURY.
THE CARRIER OF TWO IMPLANTS WAS TIGHT. THE BUCCAL PLATE OF MAXILLA BROKE. DR GRAFTED THE SITES. PT IS REPORTEDLY FINE.
THIS REPORT WAS RECEIVED OF A WOMAN WHO HAD AN INTRAOCULAR LENS IMPLANT AFTER A SUCCESSFUL PHACO. POSTOPERATIVELY, THE VISUAL ACUITY WAS SUPRISINGLY -800 AND THE EYE BEHAVED LIKE A KERATOCONUS. THE IOL WAS EXCHANGED FOR A +8.00 AND THE RESULT WAS -2.00. THE SURGEON REQUESTED THE LENS BE EVALUATED FOR THE DIOPTER. EVAL REVEALED THAT THE MEAUSREMENTS SHOWED THE LENS POWER TO BE +13.24 DIOPTER, WHICH IS WELL WITHIN TOLERANCE LIMITS. ADD'L INFO WAS RECEIVED ON 7/29/96, INDICATING THAT SECONDARY SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE LENS. NO FURTHER INFO IS EXPECTED.
A UNIT WAS BEING USED BY A PT. A PIECE OF PLASTIC WAS SUCKED INTO THE PT'S THROAT. THE PT COUGHED UP THE PLASTIC PIECE. NO FOLLOW-UP TREATMENT WAS NECESSARY.
INVESTIGATION IS IN PROGRESS. REF MFR COMPLAINT # N96-8-16-145. 510K # = K801199. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORTR DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE IF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
INTERMITTENT LOSS OF VENTRICULAR CAPTURE WAS OBSERVED.
A BALLOON RUPTURED ON THE FIRST INFLATION DURING A AV FISTULA DILATION. IT IS UNKNOWN HOW MANY ATMOSPHERES WERE ACHIEVED PRIOR TO THE RUPTURE, AND     ATTEMPTS TO GAIN FURTHER INFO HAVE BEEN UNSUCCESSFUL. THE DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION REVEALED A TWO MILIMETER HOLE LOCATED AT THE DISTAL END OF THE BALLOON OUTER LAYER AND A PIN-HOLE IN THE INNER LAYER. THE NYLON BRAIDING WAS INTACT. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURES FOR EFFECTIVE DILATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. THESE FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT.
H 6. #68 - THE PT'S CONDITION MAY HAVE CONTRIBUTED TO THIS EVENT.
INTERMITTENT VENTRICULAR OVERSENSING WAS OBSERVED.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR..
AN IMPLANT FAILED, PT IS REPORTEDLY FINE.
TWO ABUTMENTS BROKE IN FUNCTION, PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER FROM YOUR OFFICE WAS UNAVAILABLE.
IF TREATMENT PLANNER DOES NOT "SNAP" LINEAR ACCELERATOR JAWS TO CONFORM WITH A CUSTOMIZED PORT CUTOUT PRIOR TO DOSE CALCULATION BEGINNING AND SUBSEQUENTLY MAKES NO OTHER CHANGES IN THE PLAN RESULTING IN DOSE RECALCULATION, THE ISODOSE CURVES WILL REPRESENT THE NON-SNAPPED RATHER THAN THE SNAPPED JAWS. THIS WOULD PRESENT AN INCORRECT DOSE, AND SUBSEQUENTLY INCORRECT TIME/MU, CALCULATION. THIS WAS FOUND DURING SOFTWARE DEVELOPMENT AND NOT IN CLINICAL USE. NO PTS WERE INVOLVED.
COMPLAINT F299 WAS INITIATED BY A CO EMPLOYEE NOTING THAT, UNDER CERTAIN CONDITIONS, WHEN THE COLLIMATOR JAWS WERE "SNAPPED" INTO POSITION BASED ON THE CUTOUT IN A CUSTOMIZED PORT, SYSTEM WOULD NOT RECALCULATE DOSE FROM THAT DONE WHEN THE JAWS WERE NOT IN THEIR "SNAPPED" POSITION. IN THAT MEETING, THE ISSUE WAS DISCUSSED FURTHER. THERE WAS AN ESTIMATE MADE THAT THE TIME/MU CALCULATION COULD BE OFF BY 5-8% MAX BASED ON DOSE NOT BEING RECALCULATED WHEN THE JAWS WERE SNAPPED. HOWEVER, IT WAS FELT TO BE UNLIKELY THAT A USER WOULD GO THROUGH THE TELEPHOTON PAGE AND HIT DONE (TO FORCE DOSE CALCULATION) AND THEN GO BACK AND SNAP THE JAWS INTO PLACE. AND, IF THEY DID, THEY WOULD EXPECT TO SEE A DIFFERENCE IN THE ISODOSE DISTRIBUTION WHEN THAT RECALCULATION WAS DONE SO ANY FAILURE TO RECALCULATE WOULD INDEED BE NOTICED. HOWEVER, DISCUSSION EVENTUALLY LED TO THE UNDERSTANDING THAT DOSE CALCULATES BEFORE HITTING DONE ON THE TELEPHOTON PAGE AND SNAPPING JAWS INTO PLACE AFTER THIS BACKGROUND DOSE CALCULATION WAS STARTED WOULD NOT CAUSE THE CALCULATION TO STOP AND RE-START. RATHER, IT WOULD CONTINUE CALCULATION AS IF THE JAWS HAD NOT BEEN SNAPPED AT ALL. THE PROBLEM WAS INTRODUCED IN RELEASE 1.3.0 WITH THE JAW SNAPPING ENHANCEMENT WAS ADDED AND HAD NOT BEEN REPORTED BY A USER. THERE WAS NO EVIDENCE OF PTS HAVING BEEN TREATED WITH THE INCORRECT PLAN SINCE THIS WAS DISCOVERED INHOUSE. IT WAS NOTED THAT PROPER QA PRACTICE AT A CUSTOMER SITE CALLS FOR VERIFYING ALL DOSE AND TIME/MU VALUES PROVIDED BY THE RADIATION TREATMENT PLANNING SYSTEM BY PERFORMING A HAND-CALCULATION OF THE VALUE. IF THIS WERE DONE, IT WOULD BE OBVIOUS THAT DOSE HAD NOT RECALCULATED BECAUSE THERE WOULD BE A DISAGREEMENT IN VALUES BETWEEN THE HAND CALCULATION AND FOCUS. HOWEVER, CO FELT THAT IT CANNOT RELY ON THIS HAND CALCULATION BEING DONE, ESPECIALLY FOR PLANS INVOLVING MULTIPLE BEAM SET-UPS AND WHERE TREATMENT AIDS ARE BEING USED. THE CALCULATION IS JUST TOO DIFFICULT TO PERFORM IN A TIMELY MANNER. A "CUSTOMER ADVISORY" WHITE PAPER (SEE PAGE 4) WAS CREATED AND FAX'S TO ALL CUSTOMERS TO ADVISE THEM OF THE SITUATION AND WHAT STEPS TO TAKE TO AVOID THE ISSUE. THIS SAME PAPER WAS ADDED TO THE SYSTEM REPORT OF 9/96. THE PROBLEM IS FIXED IN SYSTEM RELEASE 1.4.0. THIS SOFTWARE RELEASE HAD BEEN IN DEVELOPMENT SINCE 6/96 AND WAS ABOUT TO ENTER VALIDATION TEST WHEN THE PROBLEM WAS DISCOVERED. RELEASE 1.4.0 SOFTWARE, INCLUDING A FIX TO THIS COMPLAINT, WILL BE MADE AVAILABLE TO ALL CUSTOMERS, FREE OF CHARGE, IN 10/96.
THE LEAD FRACTURED DUE TO SUBCLAVIAN CRUSH.
REFERENCE SECTION F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE IMPLANT DATE IS UNKNWON. THIS IS THE SAME EVENT AS 1640319-1996-00302.
THE STAINLESS STEEL NEEDLE PORTION OF A SUBCUTANEOUS INFUSION SET SEPARATED FROM THE REST OF THE SET AND THE PT REQUIRED HOSPITALIZATION AND MEDICAL INTERVENTION TO HAVE IT REMOVED. THE RPTR INDICATED THAT THIS WAS THE 2ND TIME IT HAPPENED.
VISUAL INSPECTION REVEALED THE STAINLESS STEEL CANNULA WAS BROKNE AT THE POINT AT WHICH IT BENDS 90 DEGREES PERPENDICULAR TO THE SET AND ENTERS THE BODY. THIS EFFECT IS CONSISTENT WITH THE TYPE OF FAILURE THAT WOULD BE OBSERVED IF THE CANNULA WAS BENT OR "FLEXED" REPORTEDLY AT THIS POINT. AFTER REPEATED FLEXING THE POINT AT THE BEND WOULD BECOME "PLASTIC" AND BREAK AND SEPARATE WHEN ANY ADD'L PRESSURE WAS APPLIED. THIS TYPE OF MOTION EXERCISES LIKE RUNNING. THE RUNNING COUPLED WITH A PLACEMENT SITE THAT OFFERED LITTLE BODY FAT TO CUSHION THE SET WOULD EXPLAIN THE DEVICE FAILURE. THE PT FUSION SET. ONE USES A TEFLON CANNULA AND ENTERS THE BODY ON BIAS RATHER THAN AT A 90 DEGREE ANGLE, WAS MORE APPROPRIATE FOR HIS PHYSIOLOGY AND ACTIVITY LEVEL.
VISUAL INSPECTION REVEALED THE STAINLESS STEEL CANNULA WAS BROKEN AT THE POINT AT WHICH IT BENDS 90 DEGREES PERPENDICULAR TO THE SET AND ENTERS THE BODY. THIS EFFECT IS CONSISTENT WITH THE TYPE OF FAILURE THAT WOULD BE OBSERVED IF THE CANNULA WAS BENT OR "FLEXED" REPEATEDLY AT THIS POINT. AFTER REPEATED FLEXING THE POINT AT THE BEND WOULD BECOME "PLASTIC" AND BREAK AND SEPARATE WHEN ANY ADD'L PRESSURE WAS APPLIED. THIS TYPE OF MOTION IS CONSISTENT WITH REPETITIVE MOTION EXERCISES LIKE RUNNING. THE RUNNING COUPLED WITH A PLACEMENT SITE THAT OFFERED LITTE BODY FAT TO CUSHION THE SET WOULD EXPLAIN THE DEVICE FAILURE. THE PT AND HIS NURSE WERE ADVISED THAT A DIFFERENT TYPE OF INFUSION SET, ONE THAT USES A TEFLON CANNULA AND ENTERS THE BODY ON BIAS RATHER THAN AT A 90 DEGREE ANGLE, WAS MORE APPROPRIATE FOR HIS PHYSIOLOGY AND ACTIVITY LEVEL.
VENTILATOR COULD NOT BE CALIBRATED. THE OSC RMS PRESSURE WAS ONLY 12 CMH20 WITH THE POWER KNOB SET TO THE MAXIMUM POSITION OF 10. WHEN WORKING PROPERLY, THE POWER KNOB IS ADJUSTED UNTIL THE OSC RMS READS 27 CMH20 AND THE POWER KNOB SHOULD READ BETWEEN 5.3 AND 6.7. THERE WAS NO PT INVOLVMENT AT ALL.
DEVICE PMA# P890057, IS FREQUENCY ADDRESSED IS LABELING? NO. IF "YES"-FREQUENCY GREATER THAN LABELING? IF "NO"- FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "YES"- SEVERITY GREATER THAN LABELED? IF "NO"-SEVERITY GREATER THAN USUAL? UNK.
THE ACTUAL SAMPLE WAS BROKEN WHEN THEY TOOK OFF THE CONNECTOR. THEY SAID THAT IT WAS EASY TO BREAK.
ACTUAL DEVICE WAS RETURNED FOR EVAL. THE TUBE WAS BROKEN JUST DISTAL TO THE FLANGE AT THE POINT WHERE THE PROXIMAL END OF THE CONNECTOR IS INSERTED INTO THE TUBE. THE WALL OF THE TUBE AROUND THE CONNECTOR EXHIBITED EVENT THICKNESS WITH NO EVIDENCE OF SHARP PROTRUSIONS. IT APPEARS THE TUBE MAY HAVE TORN AS A RESULT OF CONSTANT MANIPULATION OR ROUGH HANDLING OF THE CONNECTOR. THE INSTRUCTION SHEET CONTAINS A WARNING TO AVOID SUDDEN OR EXCESSIVE FORCE WHILE DISCONNECTING. MANUFACTURING HAS INFORMED THE APPROPRIATE PERSONNEL OF THIS COMPLAINT.
THE TIBIAL INSERT WOULD NOT LOCK SECURELY IN THE BASEPLATE. THE INSERT COULD BE EASILY DISLODGED WITH A PROBE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
H4: THE DEVICE MFR DATE IS 6/15/95. EVALUATION: THIS TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE ANTERIOR LOCKING TAB  EXHIBITS DISTORTION DUE TO HAVING BEEN CRUSHED DURING THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. A QUERY OF THE PRODUCT EXPERIENCE REPORT DURING MFR. A QUERY OF THE PRODUCT EXPERIENCE REPORT DATABASE FOUND THAT NO OTHER SIMILAR EVENT HAD BEEN REOPRTED FOR THIS LOT OF INSERTS. THE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES. IMPACTION OF A MISALIGNED INSERT DAMAGES THE ANTERIOR LOCKING TAB WHICH THEN PRECLUDES PROPER ASSEMBLY ONTO THE BASEPLATE.
DEVICE WAS REPORTED TO HAVE BROKEN DURING SURGERY.
DEVICE WAS DISCARDED. INVESTIGATION DETERMINED THAT NO PT INJURY WAS REPORTED. A SHORT SURGICAL DELAY OCCURRED. "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT."
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FRACTURE POSSIBLE OVER TIGHTENING OF SCREW. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES BONE NOT PLACED FAR ENOUGH INTO BONE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
X-TUBE ASSM 15" X 16". DEALER CLAIMS X-TUBE BROKE AT THE BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, IT CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WHEN PROGRAMMING, THE ECG SHOWED RAPID ATRIAL A-V SEQUENTIAL PACING AT THE  MAXIMUM PROGRAMMED PACING RATE (MPR). SUBSEQUENT TO RAPID PACING, SHORT RUNS OF V-TACH WERE OBSERVED. THE CUSTOMER REPRODUCED THE PHENOMENON AT TWO DIFFERENT MPRS (100 AND 120). THE EXACT EVENT DATE IS UNKNOWN.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. IF THE PACEMAKER HAS RATE ADAPTION PROGRAMMED "ON" AND IS DETECTING A LIGHT LEVEL OF EXERCISE, WHEN PROGRAMMED, THE DEVICE WILL PACE AT THE MAXIMUM PACING RATE FOR TWO CYCLES. THIS IS CAUSED BY THE PROGRAMMER LOADING AN INCORRECT RATE VALUE.
INVESTIGATION CONDUCTED. DR CITES POOR ORAL HYGIENE AS CAUSE FOR FAILURE. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. PT IS A BRUXER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
CASTER HINGE L/R RV. DEALER CLAIMS THAT THESE ARE STRIPPED.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE TIBIAL INSERT WOULD NOT SEAT IN THE BASEPLATE. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
H4: THE DEVICE MFR DATE IS 9/20/95. EVALUATION: THIS TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE ANTERIOR LOCKING TAB EXHIBITS MAJOR DISTORTION AS A RESULT OF THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. A QUERY OF THE PRODUCT EXPERIENCE REPORT DATABASE FOUND THAT NO OTHER SIMILAR EVENT HAS BEEN REPORTED FOR THIS LOT OF INSERTS. THE EVALUATION RESULT ARE INCONCLUSIVE AS TO WHETHER THIS EVENT IS DEVICE RELATED.
CONTACT STATED DR DID NOT USE OBTURATOR AS INTENDED FOR USE WITH DEVICE. THIS MAY HAVE RESULTED IN DEVICE BREAKAGE. THIS MAY HAVE RESULTED IN DEVICE BREAKAGE. NO PT INJURY WAS REPORTED AND BROKEN PIECES WERE RETRIEVED. CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT."
X-TUBE ASSEMBLY 17" X 16" SISTER CO CLAIMS X-TUBE BROKE AT THE CENTER BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
RH CHAIR ARM REST HAS SHEARED OFF, NO INJURY TO PT OR STAFF.
THE FOLLOWING IS A CLOSURE REPORT BY THE FOREIGN REPORTER. UPON FURTHER INVESTIGATION THE RIGHT HAND ARMREST WAS FRACTURED AND THE LEFT HAND ARMREST WAS NOT ABLE TO BE REMOVED. THE RIGHT HAND ARMREST HAD FRACTURED DUE TO IT BEING OVERSTRESSED. MAINTENANCE ERROR. THE MACHINE SHOULD BE CHECKED REGULARY BEFORE USE AND BROKEN PARTS REPLACED. NEW ARMRESTS HAVE BEEN SUPPLIES AND FITTED.
X-TUBE ASSEMBLY 18" X 16" CO CLAIMS X-TUBE BROKE AT THE TOP WELD, SEAT RAIL AREA.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
MEDICS WERE MONITORING A PT (AGE AND GENDER UNKNOWN). AFTER APPROX TEN MINS, THE UNIT'S MONITOR SCREEN DISPLAYED A FLATLINE ECG TRACE WHICH THEN TURNED INTO A DOTTED LINE. THEY CHANGED THE CABLE, BUT THE DISPLAY REMAINED THE SAME. THERE WAS NO ADVERSE EFFECT ON THE PT. THE MEDICS TESTED THE UNIT AFTER THE CALL AND THE UNIT FUNCTIONED PROPERLY.
MEDICS WERE ATTEMPTING TO MONITOR A 31-YR-OLD MALE PT AND A "CHECK ELECTRODES" MESSAGE APPEARED ON THE UNIT'S MONITOR SCREEN. THE ECG TRACE DISPLAYED ON THE SCREEN BECAME A DASHED LINE. THE MEDICS CHANGED THE UNIT'S BATTERY, BUT THE MONITOR DISPLAY REMAINED THE SAME. THEN, THEY SWITCHED THE UNIT FROM AUTO MODE TO MANUAL MODE WITH NO EFFECT ON THE DISPLAY. THERE WAS NO ADVERSE EFFECT ON THE PT. THE COMPLAINT ALSO INDICATED THAT THE ALLEGED MALFUNCTION OCCURRED ONCE BEFORE DURING A DEMONSTRATION. THE MEDICS WERE UNABLE TO DUPLICATE THE ALLEGED MALFUNCTION AND THE UNIT WAS RETURNED TO SVC.
REAR S/F DAB PNTD L Q2. DEALER ALLEGES SIDE FRAME BROKE AT THE BACK WELD.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER IMFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. OR THE EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
A FILTER DID NOT FULLY OPEN AFTER DEPLOYMENT. A SECOND FILTER WAS SUCCESSFULLY PLACED WITH NO PT COMPLICATIONS. THIS DEVICE REMAINS IMPLANTED AND WILL NOT BE AVAILABLE FOR EVALUATION. A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO FILTER PLACEMENT AND CONTINUAL FLUSHING OF THE CARRIER SYSTEM DURING THE IMPLANT PROCEDURE WAS NOT PERFORMED WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNKNOWN. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
REAR S/F DAB PNTD R AND L Q2. DEALER ALLEGES THE LEFT SIDE FRAME IS CRACKED AND THE RIGHT REAR SIDE FRAME IS BENT.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS INC OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REPORT RECEIVED OF J RETENTION WIRE FRACTURE WITHOUUT PROTRUSION.
5/16 X 5/8 LG SHLDR BOLT, CASTER HINGE R RV. DEALER CLAIMS THE HINGE BROKE.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE. QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A STENT PLACEMENT PROCEDURE, THE STENT SLIPPED OFF OF TWO DIFFERENT CATHETER BALLOONS WHEN ATTEMPTING PLACEMENT. A THIRD CATHETER WAS DIFFICULT TO REMOVE THROUGH THE SHEATH, POST DILATION OF STENT. THE CATHETER & SHEATH WERE REMOVED TOGETHER AND REPLACED WITH COMPETITOR'S PRODUCTS TO COMPLETE STENT POSITIONING WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.      7
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR. BLOCK H6 METHOD CODE 86 ASSIGNED AS NO SAMPLE WAS AVAILABLE & CODE 68 ASSIGNED AS THE CONCLUSION DUE TO THE OFF LABEL USE OF THE REPORTED PRODUCT.
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON USED THE DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
X-TUBE ASSEMBLY 17" X 18" DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE. QUICKIE DESIGNS INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CO RECEIVED INFO THAT A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND EPICARDIAL LEAD SYSTEM EXPERIENCED OVERSENSING AND INAPPROPRIATE THERAPY. THE ICD WAS EVENTUALLY PROGRAMMED "INACTIVE". THE OVERSENSING/INAPPROPRIATE THERAPY OCCURRED IN THE 1/3/95 TIME FRAME. THE PT PASSED AWAY ON 9/28/95 AND THE LEAD IN QUESTION WAS NOT EXPLANTED. THE EXACT CAUSE OF DEATH IS NOT KNOWN AT THIS TIME. CO EVENT ANALYSIS LEARNED OF THIS ISSUE ON 8/22/96 FROM CLINICAL FOLLOW-UP FORMS. A MODEL NUMBER 4320 LEAD, SERIAL NUMBER 023484 WAS IDENTIFIED AS THE CAUSE OF THE RTATE SENSING PROBLEM. THE ICD WAS UNDERGOING CLINICAL EVALUATION. LEAD IMPLANTED 1/31/94, PT DEATH: 9/28/95 (IMPLANTED 20 MONTHS).
THE LEAD WAS EXPLANTED ELECTIVELY. FAILURE ANALYSIS INDICATES THE LEAD IS FRACTURED WITH PROTRUSION.
THE FACILITY HAD RECEIVED A BOX MARKED AS A DUAL LUMEN DEVICE; HOWEVER, THE BOX CONTAINED A SINGLE LUMEN DEVICE. ON 8/15/96, THE MFR CONTACTED THE FACILITY'S MATERIAL MANAGER WHO STATED THAT THERE WAS NO DELAY IN SURGERY. "AFTER COMPLETELY OPENING THE KIT ON THE STERILE FIELD, IT WAS NOTED THAT THEY HAD THE WRONG DEVICE; THEEFORE, THEY REPACKED IT AS BEST AS POSSIBLE.
THIS REPORT IS BEING FILED TO REPORT CORRECTIVE DATA FROM THE MFR'S INITIAL REPORT FILED ON 9/11/96. THE MFR INITIALLY REPORTED THE EVAL "RESULTS" CODES AS:150, 200, 300 AND 862; HOWEVER, UPON FURTHER REVIEW OF THESE CODES THE MFR DETERMINED THAT THESE CODES SHOULD BE: 100, 200, 300 AND 400. IN ADDITION, FURTHER REVIEW OF THE EVAL "CONCLUSION" CODES HAS BEEN MADE AND WAS DETERMINED THAT THESE CODES SHOULD BE: 67, 66, NA AND NA, AND NOT, 57, 66, 67 AND NA. THESE CHANGES REFLECT THE RESULTS MADE BASED ON THE DEVICE EVAL AND THE AVAILABLE INFO. THE RESULTS OF THE DEVICE EVAL AND THE AVAILABLE INFO, COULD DETERMINE THE CAUSE OF THIS EVENT; HWOEVER, THE MFR DOES NOT BELIEVE THAT THIS EVENT IS DEVICE OR MANUFACTURING ERROR. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE PT HAS EXPIRED AND THE LEAD REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVAL. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON ALLEGED "INAPPROPRIATE SHOCKS". NO FURTHER INFO IS AVAILABLE.
X-TUBE ASSM 17" X 16" DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC BURCH PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE NEEDLE BROKE. THE COMPONENT WAS RETRIEVED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
REPORT RECEIVED OF FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION WITH MIGRATION AWAY FROM THE LEAD BODY.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE INSTRUMENT BROKE. THE SURGEON COMPLETED THE PROCEDURE WOTH ANOTHER INSTRUMENT. THE HOSP HAS REPORTED NO PT INJURY.
UPON RECEIPT OF THE DEVICE IT WAS NOTED THAT THE REPORTED CONDITION OF "BROKEN" REFERRED TO THE HANDLE AREA OF THE INSTRUMENT. HOWEVER, THE BROKEN COMPONENTS WERE NOT RETURNED FOR EVALUATION. THEREFORE, WE CANNOT RELIABLY DETERMINED THE EXACT CAUSE OF THE DIFFICULTY REPORTED.
CO'S INVESTIGATION IS NOW COMPLETE. H3 AND H6: THE ABOVE CODES ADEQUATELY DESCRIBED THE METHODS, RESULTS AND CONCLUSION. 86: DEVICE HISTORY WAS DOWNLOADED AND REVIEWED. 68: HISTORY WAS INCONCLUSIVE DUE TO INABILITY TO GET ADD'L CUSTOMER INFO. COMPLAINT COULD NOT BE CONFIRMED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SCOPE'S VISIBILITY WAS NOT CLEAR. THE HOSP REPORTED NO PT INJURY.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SAFETY SHIELD DID NOT FUNCTION PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
09/24/96-CORRECTED INFORMATION SUBMITTED FOR B-4 AND F-8. ADDITIONAL INFORMATION SUBMITTED FOR B-3, B-5, D-9 AND F-6. DEVICE EVALUATION INDICATED AND CODES ENTERED FOR H-3 AND H-6.
TPN WAS COMPOUNDED INCORRECTLY FOR A NEONATE. THERE WERE NO ADVERSE EFFECTS BEYOND A TEMPORARILY HIGH POTASSIUM. REPORTING FACILITY ENTERS ELECTROLYTES AND AMINO ACIDS AS X/KG FOR PEDIATRICS. RPTR NORMALLY ENTERS THE VOLUME NEEDED IN 24 HRS IN THE VOLUME FIELD, LEAVES THE RATE = 0, AND PUTS IN A 24 DURATION FOR INFUSION PERIOD. THAT WAY IF THE RATE IS TAPERING, OR IS A CYCLIC TPN, ETC, IT ISN'T CONFUSING TO THE NURSE. PHARMACY TECH ACCIDENTLY ENTERED A RATE W VERSUS O. THE MACHINE STILL PUMPED A 24 HR VOLUME OF 480ML, AND THE DEXTROSE, ORDERED IN %, WAS CORRECT, BUT THE ELECTROLYTES WERE CALCULATED AND PUMPED FOR A 2ML/HR X 24 HR = 48ML VOLUME. IN OTHER WORDS, EVERY 48ML OF THE BAG HAD THE ELECTROLYTES THAT WERE SUPPOSED TO BE IN THE WHOLE BAG, BASICALLY A 10 FOLD AMOUNT OF ELECTROLYTES. THE VOLUME, RATE AND DURATION DO APPARENTLY NOT CROSS-CHECK CURRENTLY. THE MACHINE SHOWS THE CALCULATION BRIEFLY ON THE SCREEN, BUT WHEN THE PHARMACIST CHECKED THE ENTRY, AND CHECKED THE BAG AND LABEL, HE DID NOT NOTICE THE RATE. THE MAXIMUM ELECTROLYTE WARNING DID NOT CATCH THIS. RPTR NEVER REALIZED THAT THE SYSTEM WORKED THIS WAY. FOR SOME REASON THAT RPTR COULDN'T FIGURE OUT, SOME HOSPS WANT IT TO WORK THIS WAY. CO IS PROGRAMMING A FIX SO AT LEAST YOU HAVE TO SET A PARAMETER TO WORK THIS WAY OR OTHERWISE CHANGING THE RATE WOULD CHANGE THE TOTAL VOLUME AND THEN THE PROBLEM WOULD BE OBVIOUS. REPORTING FACILITY HAD BEEN ENTERTAINING SENDING A SAMPLE OF EACH PEDIATRIC TPN FOR A POTASSIUM ANALYSIS AFTER PRODUCTION, AND NOW WILL START DOING THIS.
REPORT RECEIVED OF SUSPECTED WIRE FRACTURE WITHOUT PROTRUSION.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE INSTRUMENT LEAKED. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
PT UNDER OXYGEN THERAPY. UTILIZING OXYGEN REGULATOR ATTACHED TO OXYGEN TANK. PT GOT OUT OF CAR, HEARD HISSING SOUND AND SAW 4 FEET OF FLAMES COMING FROM DEVICE WHICH WAS ON HER SHOULDER. SHOULDER STRAP MELTED AND HER JACKET WAS ON FIRE. AFTER REMOVING JACKET, PT COLLAPSED. PT SUFFERED 3RD DEGREE BURNS TO UPPER ARM AND RT ANKLE. PHYSICAL EXAM REVEALS NO EVIDENCE OF INHALATION SMOKE INJURY OR AIRWAY THERMAL INJURY. THERE IS WORSENING OF CHRONIC HYPOXIA WITH UNCERTAIN ETIOLOGY, PERHAPS MINIMAL IRRITATION OF PRE-EXISTING, CHRONIC AIRWAY INFLAMMATION. PT DOES NOT PRESENTLY SMOKE AND HAS RECEIVED TRAINING ON PORTABLE OXYGEN USE. INVESTIGATION BY FIRE DEPT WAS UNABLE TO DETERMINE A SOURCE OF IGNITION. IN MFR'S TESTING OF DEVICE, THE UNIT OPERATED NORMALLY. (*)
X-TUBE ASSM 18" X 16" DEALER CLAIMS X-TUBE BROKE AT THE CENTER OF THE X-BRACE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE CLIPS DID NOT ADVANCE. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
SET LEAKS FROM BELOW THE FILTER. FACILITY RETURNED THE DEFECTIVE PRODUCTS TO MFR BUT MFR SENT PRODUCTS FROM THE SAME LOT. FACILITY IS CONCERNED WITH LEAKS SINCE THEY ARE USED FOR CHEMOTHERAPY.
X-TUBE ASSM 18" X 17" DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT OF THE L SIDE.
THE PRODUCT WAS APPLIED DURING A PNEUMONECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE CLIPS EJECTED PREMATURELY. THE HOSP HAS REPORTED NO PT INJURY. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER INSTRUMENT.
10/4/96-SUBMISSION OF SUPPLEMENTAL REPORT WITH ADD'L INFO IN SECTIONS D-7, D-8, D-9, D-10 AND E-1. EVALUATION INDICATED AND CODES ENTERED IN H-3 AND H-6.
WHEN SQ SET WAS BEING CHANGED THE NURSE NOTICED THAT THE NEEDLE WAS MISSING. A SEARCH FOR THE NEEDLE ON AND AROUND THE PT WAS CONDUCTED; HOWEVER, IT COULD NOT BE FOUND. PT HAD BEEN EXPERIENCING SATISFACTORY ANALGESIA, FOR HIS SEVERE PAIN.
X-TUBE ASSM 18" X 16" DEALER ALLEGES THE X-TUBE BROKE AT HINGE ON THE "T" SIDE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WHILE ESTABLISHING AN IV, USER PUSHED WHITE BUTTON TO RETRACT NEEDLE. NEEDLE DID NOT COMPLETELY RETRACT, CAUSING A DIRTY SHARP TO BE PRESENT.
DURING A PTCA PROCEDURE, THE BALLON WOULD NOT DEFLATE. A SYRINGE WAS USED TO DEFLATE THE BALLOON. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS COULD NOT VERIFY THE COMPLAINT. THE DEVICE PERFORMED WITHIN ALL RELEVANT PARAMETERS. NO LEAKS OR FUNCTIONAL DEFICIENCIES WERE DETECTED. THE CAUSE OF THE REPORTED DEFLATION DIFFICULTIES COULD NOT BE DETERMINED. NO MATERIAL OR MFG DEFICIENCIES WERE  NOTED.
REPORT RECEIVED OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
DURING A DIALYSIS TREATMENT, THERE WAS AN EXTERNAL BLOOD LEAK FROM THE PLASTIC KNOB ABOVE THE LABEL. BLOOD WAS RUNNING DOWN THE DIALYZER. THERE WAS NO PT IMPACT.
A REVIEW AND INVESTIGATION OF THE PROCESS EQUIPMENT USED TO MFR THE PLUG AS WELL AS THE PLUGGING STATION IN THE DIALYZER ASSEMBLY LINE WERE DONE TO FIND POSSIBLE REASONS FOR DEFECTS OR SMALL DAMAGES TO THE SEALING PLUG WHICH  OCCASIONALLY MAY CAUSE LEAKAGE. THE PLUGGING STATION DESIGN WAS REVIEWED AND A SMALL CHANGE WAS DONE TO THE PLUG ENTRANCE CHANNEL TO FACILITATE THE MOVEMENT OF THE PLUG AND AVOID RANDOM DAMAGES. THE ACTIVITIES ON THE PLUGGING STATION WERE DONE ON 10-3-96. THE ADJUSTMETNS OF THE COMPLETE PLUGGING STATION HAVE EARLIER BEEN RECHECKED ON 8-9-96. AS PART OF A CONTINUING IMPROVEMENT PROGRAM, THE MOULDING TOOL FOR THE PLUG WAS POLISHED TO AVOID ANY OCCURRENCE OF SURFACE ROUGHNESS. THIS ACTION IMPLEMENTED 9-2-96 WILL FACILITATE THE MOVEMENT OF THE PLUG IN THE PLUG STATION AND REDUCE ANY POSSIBILITIES FOR RANDOM DAMAGES TO THE PLUG. THE MFR WILL CONTINUE TO MONITOR AND TREND.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR TECHNIQUE/TOOLS: INTRAVASCULAR COUNTER TRACTION NO COMPLICATIONS.
DURING PRE-ANESTHESIA TESTING, THE ANESTHESIA BREATHING CIRCUIT WAS DISCOVERED TO CONTAIN EXTERNAL PHYSICAL DAMAGE TO THE GAS SAMPLING PORT ON ITS ELBOW THAT CAUSED IT TO LEAK IN EXCESS OF CO'S ACCEPTABLE STANDARDS. THERE WAS NO PT INVOLVEMENT.
10/30/96 FOLLOW-UP #01 CHANGED THE FOLLOWING SECTION: A4 WAS 08/30/96, D10 WAS NA, F WAS BLANCK, G4 WAS 08/30/96, G7 WAS INITIAL, H7 WAS NA, H11 WAS BLANK.
REPORT RECEIVED OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED 49MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 39MM AND HAS MIGRATED DOWN LEAD BODY 59MM PROXIMAL OF WELD SITE. THE PROXIMAL SECITON OF J STIFFENER WIRE MEASURES 39MM AND HAS MIGRATED DOWN LEAD BODY 59MM PROXIMAL OF WELD SITE. RECORDED MEASUREMENTS ADD UP TO 88MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURE.
DURING A DIALYSIS TREATMENT, THERE WAS AN EXTERNAL BLOOD LEAK. FROM THE PLASTIC KNOB ABOVE THE LABEL. THE BLOOD WAS RUNNING DOWN THE DIALZYER. BLOOD LOSS WAS ESTIMATED AT 10-15CC. THERE WAS NO PT IMPACT.
INVESTIGATION/DETERMINATION OF CAUSE: SAMPLES RECEIVED FROM SAME LOT NUMBER WERE TESTED IN SIMULATED DIALYSIS WITH BOVINE BLOOD OR A COLORED WATER SOLUTION IN THE THE BLOOD COMPARTMENT OF THE DIALYZER. THIS TEST WAS TO DETECT ANY LEAKS IN THE SEALING PLUG AREA. THE TESTS ARE DONE ACCORDING TO THE REQUIREMENTS IN THE ANSI/AAMI STANDARD FOR FIRST USE HEMODIALYZERS USING A PRESSURE IN THE BLOOD COMPARTMENT WHICH  IS 1.5 TIMES THE STATED MAXIMUM ALLOWABLE PRESSURE FOR THE ACTUAL DEVICE. THE RESULT FROM THE TEST INDICATED A SMALL LEAK (FEW DROPLETS) AT THE SEALING PLUG ON ONE DIALYZER WHEN THE DIALYZER WAS TESTED WITH THE COLORED WATER SOLUTION. NO LEAKS OCCURRED DURING THE TEST WITH BOVINE BLOOD. INVESTIGATION OF THE LEAKAGE DIALYZER CONFIRMED A SMALL DAMAGE ON THE SURFACE OF THE SEALING PLUG. A REVIEW AND INVESTIGATION OF THE PROCESS EQUIPMENT USED TO MFR THE PLUG AS WELL AS THE PLUGGING STATION IN THE DIALYZER ASSEMBLY LINE WERE DONE TO FIND POSSIBLE REASONS FOR DEFECTS OR SMALL DAMAGES TO THE SEALING PLUG WHICH OCCASIONALLY MAY CAUSE LEAKAGE. THE PLUGGING STATION DESIGN WAS REVIEWED AND A SMALL CHANGE WAS DONE TO THE PLUG ENTRANCE CHANNEL TO FACILITATE THE MOVEMENT OF THE PLUG AND AVOID RANDOM DAMAGES. THE ACTIVITIES ON THE PLUGGING STATION WERE DONE ON 10-3-96. ADJUSTMENTS OF THE COMPLETE PLUGGING STATION HAVE EARLIER BEEN RECHECKED ON 8-9-96. FOLLOW-UP ACTION: AS PART OF A CONTINUING IMPROVEMENT PROGRAM, THE MOULDING TOOL FOR THE PLUG WAS POLISHED TO AVOID ANY OCCURRENCE OF SURFACE ROUGHNESS. THIS ACTION IMPLEMENTED 9-2-96 WILL FACILITATE THE MOVEMENT ON THE PLUG IN THE PLUG STATION AND REDUCE ANY POSSIBILITIES FOR RANDOM DAMAGES TO THE PLUG. THE MFR WILL CONTINUE TO MONITOR AND TREND.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED AT THE WELD SITE AND APPROX 69MM PROXIMAL OF THE WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX 18MM AND HAS MIGRATED DOWN LEAD BODY APPROX 75MM PROXIMAL OF THE WELD SITE. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURES.
DURING A DIALYSIS TREATMENT, LOAD CELL WAS NOT PASSING THROUGH LINEAR TEST. AN EXCESS WEIGHT REMOVAL OF 0.5 KG OCCURRED. PT WAS GIVEN SALINE.
NO PATIENT INJURY WAS REPORTED. THE MEDICAL EQUIPMENT SERVICE TECH. (MES) REPLACED THE LOAD CELL AND CALIBRATED TO MFG SPECIFICATIONS. THERE WERE NO RELATED CPF DEFECTS REPORTED ON THIS MACHINE. ID OF PRODUCTION EQUIPMENT (N/A IF NOT USED): 1KG WEIGHT CONTROL #JF15588, 2KG WEIGHT CONTROL #JF15585, 2 KG WEIGHT CONTROL #JF15587, 5KG WEIGHT CONTROL #JF15586. TEST PROCEDURE FOLLOWED: QARA 146, REVISION F. 17001-24, A. MFG SPECIFICATIONS TESTED TO (IF NOT CLEARLY ESTABLISHED IN TEST PROCEDURE): VISUAL. REDY SERVICE MANUAL, SECTION 7-55, ULTRAFILTRATION MONITOR HYSTERESIS AND MONOTINICITY TEST. ADDITIONAL TESTING QARA 146 SECTION 10. THE RETURNED LOAD CELL ASSEMBLY WAS PLACED INTO A CALIBRATED REDY MACHINE AND CALIBRATED. THE LOAD CELL WAS THEN TESTED PER SECTION 7-55 OF THE REDY SERVICE MANUAL. THE TEST INVOLVES A 50 ML/HOUR DRIP PROVIDED BY THE MACHINE'S BLOOD PUMP. THIS DRIP WILL FILL THE RESERVOIR TO THE OVERFLOW SPOUT IN APPROX. 3 HOURS. THE MACHINE WAS IN THE CALIBRATION MODE UNDER LOAD CELL WHEN THE DRIP IS ACTIVATED. WHEN THE RESERVOIR IS FULL THE INTERNAL COMPUTER WILL LOG ANY DEFECTS FOUND IN THE TESTING PERIOD, AND THE SPECIFICATION ALLOWS NO MORE THAT 2 ERRORS WITH AN EXCEEDED ERROR VALUE OF 2 HEX. THIS TEST WAS RAN TWICE WITH NO 0 ERRORS. THEREFORE, THIS TESTING INDICATED THAT THIS LOAD CELL MET MFG SPECIFICATIONS. HOWEVER, WHEN THE ASSEMBLY WAS VISUALLY INSPECTED IT WAS NOTICED THAT IT WAS VERY DIRTY. THIS DIRTY CONDITION IS CONSIDERED TO BE THE CAUSE OF THE REPORTED CONDITION, BECAUSE IN SECTION 6.5.8 IN THE REDY SERVICE MANUAL IT STATES "EVERY SIX MONTHS OR 500 HOURS CHECK FOR SALT BUILDUP UNDER THE LOAD CELL AND ESPECIALLY UNDER THE LOAD CELL OVERLOAD PROTECTION BOLT. IF SALT BUILDUP IS APPARENT, REMOVE THE SALT WITH A FEELER GAUGE OR BRUSH. BLOW WITH COMPRESSED AIR TO REMOVE ALL RESIDUE AND CHECK THE CALIBRATION OF THE LOAD CELL BEFORE CONTINUING WITH A TREATMENT." THIS DEBRIS WILL AFFECT THE TRAVEL AND/OR MOVEMENT OF THE ASSEMBLY AND CAUSE THE REPORTED CONDITION. THE ASSEMBLY COULD MEET SPECIFICATION IN THIS TEST BECAUSE THE DEBRIS COULD CAUSE AN INTERMITTENT PROBLEM. ADDITIONAL TESTING FOR THIS MDR IS AS FOLLOWS: THERE IS NO PREVIOUS FAILURE HISTORY FOR THIS COMPONENT. POWER CYCLING THIS MACHINE IS NOT AFFECTIVE BECAUSE THE MACHINE DOES NOT INSTANTLY TURN ON WHEN THE POWER IS TURNED ON. ADDITIONALLY THE COMPONENT WAS RAN FOR 6 HOURS WHILE THE ABOVE TESTING WAS IMPLEMENTED. THE STANDARD RUN TIME FOR A DIALYSIS TREATMENT ON THE REDY MACHINE IS THREE HOURS. THEREFORE, THE ASSEMBLY WAS STRESSED TWICE AS LONG AS ITS NOMRAL RUN TIME,   AND THE ASSEMBLY STILL MET SPECIFICATION. TEMP. DOES NOT AFFECT THIS ASSEMBLY, THEREFORE A TEMP. STRESS TEST WAS NOT IMPLEMENTED. THE ONLY RELATED COMPONENT FAILURE WOULD BE A SLOT 2 FAILURE AND IF THE SLOT 2 WAS TO FAIL THERE WOULD BE MORE DEFECTS THEN THE REPORTED CONDITION. THE VOLTAGES CAN NOT BE ADJUSTED WITHOUT HAVING THE RECALIBRATE THE ASSEMBLY AND RECALIBRATING THE ASSEMBLY WOULD READJUST THE VOLTA
SAFETY SYRINGE DIDN'T LOCK. RN WAS STUCK AFTER SYRINGE WAS USED. SYRINGE WAS NOT SAVED. CUSTOMER REPORTS SYRINGE SAFETY SHIELD FAILED TO LOCK. NEEDLESTICK OCCURRED WHEN GETTING READY TO DISPOSE OF SYRINGE AND NEEDLE. A MINUTE PUNCTURE WAS REPORTED.
ACTUAL DEVICE WAS DISCARDED. INVESTIGATION IS IN PROCESS. REFERENCE MFR. COMPLAINT #C96-8-15-121. 510K #=K924511. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
REPORT RECEIVED OF SUSPECTED RETENTION WIRE FRACTURE.
MFR CHANGED THE PACKAGING ON THE ELECTROHYDRAULIC LITHOTRIPTOR PROBES AND "STOPPED STERILIZING THEM." NOTHING ON THE NEW PACKAGING INDICATES THE PRODUCT MUST BE STERILIZED BEFORE USE. THE PACKAGING HAS THE TERM "GAMMA" AND "EXP" WHICH WOULD INDICATE DATE OF GAMMA IRRADIATION AND AN EXPIRATION DATE OF STERILE PRODUCT. THERE IS ALSO A CLAUSE WHICH STATES IF THE PRODUCT IS RESTERILIZED, THE INSTITUTION ASSUMES RESPONSIBILITY FOR EFFECTIVENESS. THE PACKAGING SHOULD STATE "UNSTERILE" IF THE PRODUCT HAS NOT BEEN STERILIZED. (*)
REPORT OF ALLEGED "PRESSURE LIMIT CONTROL VALVE STUCK AND ALARMED. NO PT HARM."
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F. TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL.
REPORT OF ALLEGED "DEVICE STOPPED CYCLING, WITH NO AUDIBLE OR VISUAL ALARMS. NO PT HARM." TESTING BY MFR FOUND DEVICE FULLY FUNCTONAL.
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO CYLINDER ANEURYSM.
SURGERY WAS SCHEDULED BECAUSE THE PT'S SPACING THRESHOLD HAD CHANGED AND THE PACING LEAD IMPEDANCE HAD DROPPED. DURING SURGERY IT WAS FOUND THAT THE DEVICE HAD FLUID IN THE HEADER DUE TO NO CAP SCREWS OR SET SCREWS. THE DEVICE WAS EXPLANTED.
F 11. CONTACT PERSON UNABLE TO PROVIDE CO WITH REPORT INFO. H3. THE ICD WAS SUBJECTED TO AN ELECTRICAL LIFE TEST AND VISUAL INSPECTION. THE ICD MET ALL SPECS AND DISPLAYED NORMAL DEVICE CHARACTERISTICS.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACTION--CROSSOVER OF CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAND OR DAMAGE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO AUTO INFLATION SECONDARY TO ENCAPSULATION OF THE RESERVOIR.
ON 8/26/96, CO WAS INFORMED ON A DEATH CERTIFICATE THAT THE PT HAD EXPIRED DUE TO VENTRICULAR FIBRILLATION.
H3. EVALUATION SUMMARY: THE ICD WAS SUBJECTED TO AN ELECTRICAL LIFE TEST AND VISUAL INSPECTION. THE ICD MET ALL SPECS AND DISPLAYED NORMAL DEVICE CHARACTERISTICS.
DR WAS ATTEMPTING TO ADVANCE THE FILTER THROUGH THE INTRODUCER WITH THE IMPLANTATION CANNULA USING A RIGHT-SIDED FEMORAL APPROACH. AS HE ADVANCED THE FILTER THROUGH THE INTRODUCER, THE FILTER PERFORATED THE INTRODUCER OUTSIDE THE PT'S BODY. THE ENTIRE UNIT WAS WITHDRAWN WITHOUT COMPLICATION. DATE DEVICE EXPIRES: 3/20/2001.
SAMPLE IS BEING EVALUATED BY MFR. ADD'L INFO TO FOLLOW. DISCLAIMER: B BRAUN MEDICAL INC IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, VOLUME 49, RELEASE NUMBER 180, DATED FRIDAY SEPTEMBER 14, 1984, SECTION 803 (MEDICAL DEVICE REPORTING) SUBSECTION 803.24. B BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CAUSAL RELATIONSHIPS TO DEVICES MANUFACTURED OR DISTRIBUTED BY B.BRAUN MEDICAL INC.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDERS.
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT DUE TO FLUID LOSS. NON CO CYLINDERS WERE REMOVED. ANOTHER DEVICE WAS IMPLANTED.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. TUBING WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO THE VALVES BEING WORN OUT.
CYLINDER DOES NOT INFLATE. CYLINDER DOES NOT INFLATE.
X-TUBE ASSEMBLY 20" X 18". DEALER CLAIMS X-TUBE BROKE IN THE MIDDLE AT ONE OF THE WELDS.
HIGH ETRESS FACTOR AT CENTEER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. ANOTHER DEVICE WAS IMPLANTED.
FOLEY-CATHETER WAS INSERTED ON 8/2/96 FOLLOWING STONE REMOVAL PROCEDURE. ON 8/7/96, CATH BALLOON WOULD NOT DEFLATE FOR CATHETER REMOVAL. DR INJECTE D MINERAL OIL INTO BALLOON & WAITED 24 HRS. DR THEN INJECTED ALCOHOL INTO BALLOON & THE BALLOON BURST. A CYSTOSCOPY WAS PERFORMED TO REMOVE BALLOON FRAGMENTS FROM THE PTS BLADDER. NO FURTHER COMPLICATIONS REPORTED.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT AS DEFINED IN THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT RECURS. NO EVAL. WAS PERFORMED AS NO SAMPLE WAS RETURNED FOR EVAL. DEFLATION CAPABILITIES OF FOLEY CATHETERS ARE 100% CHECKED IN-PROCESS. CODE 2365=LABELED; CODE 1149=LABELED, CODE 1049=LABELED. ADDL INFO HAS BEEN REQUESTED FROM THE USER FACILITY BUT HAS NOT BEEN RECEIVED.
INFORMATION SUPPLIED IN SECTION F WAS PROVIDED BY THE MANUFACTURER, NOT THE USER FACILITY.
FOLLOW-UP INFORMATION FROM SURGEON DESCRIBES AN UNK MATERIAL WHICH WAS NOTED ON THE ANTERIOR SURFACE OF THE LENS AFTER INSERTION. THE LENS WAS IMMEDIATELY REMOVED AND EXCHANGED WITH ANOTHER LENS AND NO FURTHER PROBLEMS WERE EXPERIENCED. PT IS DOING WELL WITH CURRENT VA OF 20/25.
DEVICE WAS REMOVED FROM THEE PT AN ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS X-TUBE BROKE AT THE WELD ON THE TOP LEFT SIDE.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDERS.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO FRACTURE.
CYLINDER HAD A LEAK AT THE PROXIMAL END.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIMS X-TUBE BROKE AT THE SEAT RAIL AREA.
DR'S OFFICE REPORTS A LENS REPLACEMENT WAS PERFORMED. INFO RECEIVED INDICATES THAT COMPLICATIONS WERE EXPERIENCED DURING THE ORIGINAL IMPLANTATION PROCEDURE ON 4/23/96 INCLUDING: POSTERIOR CAPSULE RUPTURE, VITREOUS BULGE, MAJOR VITREOUS LOSS, AND THE NUCLEUS DROPPED. AN IRIDECTOMY AND VITRECTOMY WERE PERFORMED AT THE TIME OF SURGERY. ON 5/1/96 A VITRECTOMY AND NUCLEUS REMOVAL WERE PERFORMED. ON 6/20/96 A CULTURE WAS TAKEN BUT NO GROWTH WAS OBSERVED. ON 8/27/96 A LENS REPLACEMENT PROCEDURE WAS PERFORMED DUE TO INFLAMMATION. INTRAVITREAL ANTIBIOTICS WERE INSTILLED AT THIS TIME. THE PHYSICIAN INDICATES THAT THE EVENT IS CONTINUING WITH TREATMENT. DATE DEVICE EXPIRES: 11/30/2000.
EVALUATION OF THE LENS REVEALS THAT IT WAS WITHIN SPECS AND THE PRODUCT HISTORY RECORDS MET ALL RELEASE CRITERIA. THE MFR'S INTERNAL REF # IS 96L4728. THIS REPORT WAS MAILED IN TO FDA ON: 9/24/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A CO PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
DEVICE WAS REMOVED FROM THE PT AND INFLATABLE DEVICE IMPLANTED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
ANOTHER DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO. INFO ACQUIRED ON 10/1/96 INDICATES REASON AS WOULD NOT INFLATE.
A SINGLE CYLINDER WAS REMOVED FROM THE PT AND REPLACED BECAUSE IT WOULD NOT FULLY INLFATE-DIFFICULT DEFLATION.
HOSP REPORTS HAPTIC BROKE DURING INSERTION AND INCISION HAD TO BE WIDENED IN ORDER TO FACILITATE REMOVAL OF THE LENS. DATE DEVICE EXPIRES: 5/31/2001.
THE INITIAL REPORT WAS RECEIVED BY MFR ON 8/28/96. ADDITIONAL INFO WAS RECEIVED ON 10/25/96 NECESSITATING A SUPPLEMENTAL FILING. THIS REPORT WAS MAILED IN TO FDA ON: 11/22/96 DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED = 1
X-TUBE ASSEMBLY 18" X 18". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACTION-COULD NOT INFLATE AND PAIN AT THE BASE OF THE PENIS.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE.
EVALUATION OF THE RETURNED LENS REVEALED THE SURFACE WAS COVERED WITH BLOOD AND CLINICAL SOLUTION AND HAD ONE BENT HAPTIC. THE ORIGINAL REPORT STATED THE SURGEON BENT THE HAPTIC UPON INSERTION. THIS REPORT WAS MAILED IN TO FDA ON :10/17/96. NUMBER OF PERSONS AFFECTED = 1.
LENS WAS RETURNED TO THE MFR AND EVALUATED.
ON 7/1/93 A MALLEABLE DEVICE WAS IMPLANTED. ON 6/11/96 THE MALLEABLE DEVICE WAS REMOVED FROM THE PT AND AN INFLATABLE DEVICE IMPLANTED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
X-TUBE ASSEMBLY 16" X 18". DEALER CLAIMS X TUBE BROKE AT THE MIDDLE.
INFO RECEIVED ON 8/29/96 INDICATES THE PT STATES TUBING IS VISIBLE FROM SKIN INCISION.
DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION, DATE NOT INDICATED. A MALLEABLE DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO.
MEDICS ARRIVED TO FIND A MALE PT IN HIS FORTIES WHO WAS IN FULL ARREST. THE EMT'S ATTACHED THE UNIT TO THE PT AND TURNED THE UNIT ON. THE UNIT'S MONITOR SCREEN WAS DISTORTED AND A "CHECK ELECTRODES" MESSAGE WAS FLASHING. THEY TURNED THE UNIT OFF AND THEN ON AGAIN AND THE UNIT FUNCTIONED PROPERLY FOR THE DURATION OF THE TRANSPORT. WHEN THE EMT'S ARRIVED AT THE FACILITY'S ER, A PHYSICIAN ATTEMPTED TO PACE THE PT. WHEN THE UNIT WAS SWITCHED TO PACE MODE, THE UNIT'S MONITOR SCREEN DISPLAYED "PACER/DEFIB FAULT", CABLE FAULT", "STATUS 41" AND "STATUS 42" MESSAGES. THE FACILITY STAFF OBTAINED ANOTHER UNIT (MFR UNKNOWN) AND CONTINUED TO TREAT THE PT. THE PT DID NOT SURVIVE THE CODE. THE COMPLAINANT INDICATED THAT THE PT WAS PULSELESS AND APNEIC WHEN HE ARRIVED AT THE FACILITY. THE COMPLAINANT ALSO INDICATED THAT THE ALLEGED MALFUNCTION DID NOT CONTRIBUTE TO THE PT OUTCOME.
X-TUBE ASSEMBLY 20" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
DEVICE WAS REMOVED FROM THE PT DUE TO "LEAKING."
PT ALLEGES THIS IS AN EMERGENCY; HAVE TO HAVE IMMEDIATE SURGERY, DUE TO IMPLANTS RUPTURED 2-4 YEARS AGO. PT ALSO ALLEGES HEALTH PROBLEM. SHE DID NOT GIVE THE NAME OF THE MFR OR IMPLANT DATE.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE IT WOULD NOT INFLATE.
QR AXLE W/NUT. DEALER CLAIMS QR AXLE BROKE. CENTER BUTTON PULLED OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
BOTH CYLINDERS PERFORMED WITHIN SPECIFICATIONS.
PT ALLEGES SHE RECEIVED IMPLANTS ON AN UNK DATE. PT ALSO ALLEGES SHE HAS PROBLEMS AND NEEDS TO HAVE HER IMPLANTS REMOVED; HOWEVER, NO SPECIFICS WERE GIVEN.
COMPLAINANT STATES THAT SHE IS HAVING PROBLEMS WITH HER RIGHT HIP. THE HIP WAS IMPLANTED IN 1985. CO IS UNABLE TO CONFIRM IF THIS PRODUCT WAS MFG BY CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. D1, CO IS UNABLE TO DETERMINE IF THE DEVICE WAS MFG BY CO OR ANY OF ITS SUBSIDIARIES.
REPORTED IN JOURNAL "PERIODIC INTERMITTENT ELECTROMECHANICAL DISSOCIATION: HEMODYNAMIC CORRELATE OF A MALFUNCTIONING MECHANICAL PROSTHETIC VALVE". CATHETERIZATION AND CARDIOVASCULAR DIAGNOSIS, AUG 4, 1996;38:377-378. THIS ARTICLE WAS REGARDING A CASE STUDY OF A 36 YR OLD MALE WHO EXPERIENCED ELECTROMECHANICAL DISSOCIATION APPROX. 20 HRS POST IMPLANT. REOPERATION REVEALES DISC STUCK IN THE CLOSED POSITION WITH A SMALL BIT OF CHORDAE WEDGED BETWEEN THE DISC AND THE VALVE HOUSING. THE TISSUE WAS EXCISED AND THE VALVE WAS REORINTED AND REMAINS IMPLANTED AT THIS TIME. CONCLUSION: RECOGNITION OF THIS HEMODYNAMIC PATTERN SHOULD LEAD TO IMMEDIATE CONSIDERATION OF AN INTERMITTENT INTRACARDIAC OBSTRUCTION SUCH AS A MALFUNCTIONING PROSTHETIC VALVE.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." F10 CODES: PT CODE #1721-LABELED, #2369-LABELED. DEVICE CODES: 1309-LABELED, 1526-LABELES. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A." H3 ANALYSIS: THIS EVENT WAS REPORTED THROUGH A JOURNAL ARTICLE. THE AUTHOR DID NOT RETURN SEVERAL CORRESPONDANCES REQUESTING ADD'L INFO. IN ADDITION, THE DEVICE REMAINS IMPLANTED AND THEREFORE COULD NOT BE EVALUATED BY THE MFR. HOWEVER, THE EVENT DESCRIBED INDICATES THAT THE VALVE FUNCTIONED AS EXPECTED AND THE EVENT WAS CAUSED BY A PHYSIOLOGICAL CONDITION OF THE PT ALONG WITH THE OPERATING TECHNIQUE.
DEVICE WAS IMPLANTED ON 1/22/87. A CYLINDER WAS REVISED ON 2/5/91. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 7/16/96 DUE TO INADEQUATE RIGIDITY-RIGHT SIDE, LEFT SIDE NONFUNCTIONAL.
CYLINDER DID NOT MAINTAIN RIGIDITY. CYLINDER DID NOT MAINTAIN RIGIDITY.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION-RIGHT EMIT LINE FROM CYLINDER.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
PT ALLEGES RECEIVING IMPLANTS OF AN UNK MFR AND ON AN UNK DATE. PT ALLEGES MEMORY WAS DAMAGED.
H3 - AVAILABILITY OF DEVICES UNK AT THIS TIME.
CASTER HINGE R RV. DEALER CLAIMS CASTER HINGE IS STIPPED.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES ITS CONTRACT SVC FIRMS OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED, REASON AND DATE NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
REPORTS ALLEGES PATIENT'S MAMMOGRAM OF AUG. 15, 1996 SHOWED BOTH IMPLANTS WERE RUPTURED. REPORT ALSO STATES DURING REMOVAL SURGERY THE RIGHT IMPLANT WAS FOUND TO HAVE A PIN HOLE WITH A SLICK COVERING OVER THE ENTIRE SURFACE OF THE IMPLANT AND ON THE LEFT SIDE THERE WAS A COMPLETE RUPTURE OF THE IMPLANT WITH FREE SILICONE LINING THROUGHOUT THE POCKET. A COMPLETE CAPSULECTOMY WAS CARRIED OUT ON BOTH SIDES.
EMT'S ATTACHED A UNIT TO A PT (AGE AND GENDER UNKNOWN). WHEN THEY ATTEMPTED TO ANALYZE THE PT'S RHYTHM, AN "ECG LEAD OFF" MESSAGE APPEARED ON THE UNIT'S MONITOR SCREEN. THE UNIT WAS IN AUTO ANALYZE MODE. THE EMT'S ADJUSTED THE UNIT AND CABLE, AND THE UNIT BEGAN TO ANALYZE THE PT'S RHYTHM. THE UNIT CHARGED TO 200J AND THE EMT'S DEFIBRILLATED THE PT. WHEN MEDICS ARRIVED THEY SWITCHED THE PT TO A PD1400 (SERIAL NUMBER UNKNOWN) AND CONTINUED THE CODE. THEY DETERMINED THAT THE PT'S RHYTHM WAS IN ASYSTOLE. THE PT DID NOT SURVIVE THE CODE. WHEN THE EMT'S PRINTED A STRIP, IT INDICATED THAT THE UNIT HAD NOT DELIVERED A 200J DEFIBRILLATION ATTEMPT.
THE CYLINDERS AND RESERVOIR WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-RESERVOIR. CYLINDERS SUBCUTANEOUS POSITION DISTALLY (NO TUNICA IN RECONSTRUCTED PENIS). CX CYLINDERS IN GELSOFT "WINDSOCK".
ON 3/15/96 AN ACCESSORY KIT WAS USED AT THE SURGERY. IT IS UNKNOWN IF ANY COMPONENTS WERE REMOVED OR REPLACED AT THIS TIME. REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
X-TUBE ASSEMBLY 19" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
THE CYLINDERS WERE REMOVED FROM THE PT DUE TO FLUID LOSS-HOLE IN LEFT CYLINDER-AND REPLACED.
MEDICS WERE TREATING A PT (AGE AND GENDER UNKNOWN) DURING A CODE SITUATION. THE MEDICS CHARGED THE UNIT (JOULE SETTING UNKNOWN) AND THE UNIT LOST POWER. THE PT EXPIRED WHILE MEDICS WERE OBTAINING ANOTHER BATTERY FOR THE UNIT.
THE ID DEVICE WAS ORIGINALLY IMPLANTED AS AN INVESTIGATIONAL DEVICE UNDER IDE STUDY #G870013 AND WAS NOT AVAILABLE FOR DOMESTIC COMMERCIAL DISTRIBUTION. THE DEVICE WAS REPORTED AS SURGICALLY REVISED AFTER AN IMPLANTATION PERIOD OF (82) MONTHS. RADIOGRAHIC EVAL WAS REPORTED TO HAVE REVEALED EVIDENCE OF OSTEOLYSIS APPROX (11) MONTHS PRIOR TO THE REVISION SURGERY OF 5/1/96. AT THE REVISION SURGERY, THE PHYSICIAN REPORTED THAT THE PERIPHERY OF THE METAL SHELL WAS FIXED, YET OSTEOLYSIS OF THE DEFECTS WERE OBSERVED THROUGHOUT THE ACETABULUM. THE ACETABULAR SHELL, MODULE POLYETHYLENE BEARING INSERT AND FEMORAL STEM'S BEARING HEAD WERE REPORTEDLY REPLACED AT THE REVISION SURGERY.
H6 EVAL CODES. METHOD, #86 OTHER (DEVICE MFG. RECORDS REVIEWED) THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE PACKAGE INSERT STATES, IN PERTINENT PART, "LOOSENING OF TOTAL HIP COMPONENTS CAN OCCUR. LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATIONS OR MECHANICAL PROBLEMS, WITH THE SUBSEQUENT POSSIBILITY OF BONE EROSION AND/OR PAIN." THE PACKAGE INSERT CONTINUES BY STATING, REVISION, ARTHODESIS OF THE INVOLVED JOINT, GIRDLESTONE AND/OR AMPUTATION OF THE LIMB." DISCLAIMER: SUBMISSION OF INFO BY CO UNDER THE MDR REGULATION DOES CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CASUAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFO ACT.
THE LEFT CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO LEFT CYLINDER ANEURYSM.
OR AXIE MAG W/SPER AND QUAD NUT AND 24" 6S PNEU INSERT HR PIST. DEALER ALLEGES THE CUSTOMER," STATED THE QUAD QUICK RELEASE WILL NOT STAY IN THE LOCKED POSITION". THE DEALER CLAIMS THE WHEELS HAVE COME OFF WHILE THE CHILD IS BEING LOADED ONTO A BUS.
NO FAILURE FOUND. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ON 8/23/93 DEVICE WAS IMPLANTED. INFO RECEIVED ON 8/28/96 INDICATES THE PT ALLEGES THE DEVICE QUIT FUNCTIONING. ADD'L LOT/SER # 1944 001, 5918T 009.
DEVICE WAS REMOVED FROM THE PT DUE TO AN ANEURYSM OF BALLOON. A MALLEABLE DEVICE WAS IMPLANTED.
CYLINDER PERFORMED WITHIN SPECFICATIONS. CYLINDER WAS FUNCTIONAL. PEUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS - LEFT CYLINDER.
PUMP PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
REAR S/F DAB PNTD 1 Q2. DEALER CLAIMS: CRACKED AT THE HOLES.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THIER EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS - LEFT CYLINDER.
THE BALLOON AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-TUBING BETWEEN CYLINDERS AND PUMP.
PUMP PERFORMED WITHIN SPECIFICATIONS. TUBING WAS FUNCTIONAL. TUBING HAD A WEAR LEAK.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO SPONTANEOUS INFLATION.
DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED, AND REPLACED. CO HAS REQUESTED ADD'L INFO.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION-PUMP/SCROTAL.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO DIFFICULTY OPERATING THE DEVICE. ADD'L LOT/SER # 5498T 010, AD255 004.
TUBING WAS REPAIRED. DIFFICULT TO PUMP DUE TO TUBING OVERLYING PUMP.
THE PT WAS IN THE HOSP FOR SURGERY, AND THE PACER CLINIC WAS CALLED TO DO A ROUTINE POST-SURGERY CHECK. THE PROGRAMMER SHOWED THE DEVICE RESET SCREEN AND NO MAGNET BEHAVIOR COULD BE ELICITED. A BACKUP RESET WAS PERFORMED SUCCESSFULLY.
REF F10 OF THIS FORM FOR THE EVENT PROBLEM CODES.
AN AUS DEVICE WAS IMPLANTED ON 3/21/91. ON 3/18/96 A REVISION SURGERY OCCURRED DUE TO EROSION. IT IS NOT INDICATED WHAT WAS REMOVED OR REPLACED. CO HAS REQUESTES ADD'L INFO.
THE BALLOON AND THE SKIN DISK DO NOT MAKE A TIGHT SEAL; THESE TUBES WERE PLACED SURGICALLY AS PRIMARY TUBES. PTS HAD SKIN EXCORIATION DUE TO GASTRIC ACID LEAKAGE. TREATMENT INCLUDED CLEANING UP THE SITES AND USE OF TOPICAL RX PRODUCTS SUCH AS DECUBITUS OINTMENTS. SURGICAL DEBRIDEMENT WAS NOT NECESSARY. THE BALLOONS WERE FULLY INFLATED. THE DR FELT THE SKIN DISK HAD MOVED RESULTING IN GASTRIC ACID LEAKAGE AND SUBSEQUENT SKIN BREAKDOWN. TWO PT INVOLVED.
REPORTER ORIGINALLY REPORTED TWO PTS INVOLVED. SUBSEQUENT INFORMATION INDICATED 11 PTS WERE INVOLVED.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS - CYLINDER. ADD'L LOT/SER # 9914P 001, 8089M 009.
ON 3/13/94 AN AUS DEVICE WAS IMPLANTED. ON 5/22/95 THE BALLOON WAS REVISED.ON 8/10/95 A TANDEM CUFF WAS IMPLANTED. ON 8/22/96 THE TANDEM CUFF WAS REMOVED FROM THE PT AND A SINGLE CUFF IMPLANTED DUE TO DISLOCATION OF THE SECOND CUFF.
BOTH CUFFS PERFORMED WITHIN SPECIFICATIONS.
INFO RECEIVED ON 8/28/96 INDICATES PT IS DISSATISFIED WITH LACK OF RIGIDITY OF AND LENGTH OF LCXP. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.
THE TIP OF THE DRILL BIT BROKE DURING THE SURGICAL PROCEDURE AND REMAINED EMBEDDED IN THE PT. SURGERY WAS PROLONGED WHILE THE SURGEON REMOVED THE BROKEN PIECE FROM THE PT'S LEG. THE PT SUFFERED NO COMPLICATIONS AS A RESULT OF THIS.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEROF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES.
THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS. ADD'L LOT/SER # 1395J 012, 1754J 004.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL.
ON 5/29/96 AN IPP DEVICE WAS IMPLANTED. ON 8/2/96 THE PUMP WAS REVISED. ON 8/24/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION.
THE DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO A PUNCTURE-PROBABLY BY THE CANCELLOUS BONE IN THE PEYRONIES DISEASE.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT DUE TO FLUID LOSS AT RIGHT CYLINDER AND REPLACED.
PUMP PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO THE DEVICE NOT INFLATING.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. PUMP HAD A FATIGUE LEAK.
THE LEFT CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-PUMP TUBING.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
A DEVICE WAS IMPLANTED, DATE NOT INDICATED. ON 2/16/96 THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED DUE TO FLUID LOSS. CO HAS REQUESTED ADD'L INFO.
A CONNECTOR WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-DISCONNECTION BETWEEN CYLINDER AND PUMP.
DEVICE WAS IMPLANTED, DATE NOT INDICATED. ON 5/29/96 THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
PHIMOSIS DEVELOPED AND VENTRAL FORESKIN SPLIT WITH ESCHAR. A CIRCUMCISION WAS PERFORMED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT REMOVAL DUE TO FAILURE OF THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE.
A MES (MEDICAL EQUIPMENT SVC) TECHNICIAN EXAMINED THE MACHINE AND THE UF PUMP THERMAL FUSE WAS REPLACED. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT A SIMILAR INCIDENT OCCURRED TWO DAYS PRIOR TO THE INCIDENT IN THIS REPORT (CPF #0996123C3). A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE TECHNICIAN AT THE FACILITY FOUND THE UF (ULTRAFILTRATION) PUMP TO BE FAULTY. THE THERMAL FUSE WAS REMOVED FROM THE RETURNED UF PUMP. THE THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE OHM METER SHOWED 00.1 OHMS, INDICATING THE THERMAL FUSE IS GOOD. THE THERMAL FUSE WAS DISASSEMBLED. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS INT HE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: NO. TRAINING REQUIRED NO.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACES DUE TO DEFORMATION OF CYLINDER-PERMANENCE.
ON 11/29/90 DEVICE WAS IMPLANTED. ON 11/10/91 THE CYLINDERS AND RESERVOIR WERE IMPLANTED. ON 3/7/96 THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
THE RESERVOIR WAS REMOVED FROM THE PT DUE TO FLUID LOSS AND REPLACED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION - INADEQUATE RIGIDITY/LOSS OF RIGIDITY DURING COITUS.
THE DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED, AND REPLACED. CO HAS REQUESTED ADD'L INFO.
THIS BASKET SUCCESSFULLY ENGAGED A STONE. RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE BASKET FROM THE URETER AT THE PELVIURETERIC JUNCTION. CONTINUED MANIPULATION RESULTED IN DETACHED OF THE PROTECTIVE SHEATH AND HANDLE FROM THE BASKET AND ENTIRE WIRE ASSEMBLY. IN AN ATTEMPT TO REMOVE THE BASKET AND WIRE, CONTINUAL MANIPULATION WAS EXERTED AGAINST RESISTANCE. THE BASKET WITH THE ENCAPSULATED STONE WAS SUBSEQUENTLY REMOVED, HOWEVER, URETERAL DAMAGE AT THE PELVIURETERIC JUNCTURE NECESSITATED A NEPHRECTOMY. THE PT 'S CONDITION IS GOOD AND HAS SINCE BEEN DISCHARGED. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVAL. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. FOLLOW UP INDICATED THE DEVICE FUNCTIONED APPROPRIATEDLY, HOWEVER, WITHDRAWAL OF THE DEVICE AND ENCAPSULATED STONE MET WITH RESISTANCE. CONTINUAL EXERTION AGAINST THIS RESISTANCE CONTRIBUTED TO THIS EVNET. CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: "IF RESISTANCE IS ENCOUNTERED WHILE ATTEMPTING TO WITHDRAW THE BASKET INTO THE SHEATH OR THE SHEATH THROUGH THE SCOPE, DO NOT EXERT EXCESSIVE FORCE."
MEDWATCH WAS RECEIVED FROM THE USER FACILITY AND IS ATTACHED. THE USER FACILITY REPORT HAS NO REPORT NUMBER.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO AUTO INFLATION. ADD'L LOT/SER # BW859 005, CA914 009.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER HAD OR DAMAGE.
DEVICE WAS REMOVED FROM THE PT DUE TO A "BREAK OF THE SKIN."
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT REMOVAL. DUE TO FAILURE OF THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE. PT UNDERWENT AN UNSCHEDULED TREATMENT TO REMOVE THE WEIGHT.
A MES (MEDICAL EQUIPMENT SVC) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE TECHNICIAN AT THE FACILITY FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE FAULTY. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE OHM METER SHOWED 00.1 OHMS, INDICATING THE THERMAL FUSE IS GOOD. THE THERMAL FUSE WAS DISASSEMBLED. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGE OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT, REFER TO FAR #960016). CUSTOMER CONTACTED: NO. SALES/SVC CONTACTED BY INVESTIGATOR NO. TRAINING REQUIRED? NO.
THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-RESERVOIR.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-LEFT CYLINDER.
DEVICE WAS REMOVED FROM THE PT DUE TO SCROTAL SWELLING AND INFECTION. ANOTHER DEVICE WAS IMPLANTED.
TUBING WAS FUNCTIONAL. TUBING HAD OR DAMAGE. PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD OR DAMAGE. CYLINDER HAD A FATIGUE LEAK.
DURING A DIALYSIS TREATMENT, THE ARTERIAL/VENOUS PRESSURES WERE READING LOW ON THE SCREEN. FOUND BROKEN BLOOD PUMP ROTOR SPRING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE MES (MEDICAL EQUIPMENT SVC) TECHNICIAN FOUND A BROKEN BLOOD PUMP ROTOR SPRING AND REPLACED IT WITH A NEW ONE. THERE WERE NO RELATED CPF DEFECTS REPORTED. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT BOTH OF THE SPRINGS ON THE ROTOR WERE BROKEN. UPON DISSASSEMBLY OF THE ROTOR IT WAS NOTICED THAT ONE OF THE SPRINGS WERE BROKE IN FOUR PIECES, THE OTHER ONE WAS BROKEN IN TWO PIECES. THE ABOVE INFO INDICATES THAT THE DIFFICULTIES WITH THE ARTERIAL AND VENOUS PRESSURES THE FACILITY HAD AS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY TWO BROKEN ROTOR SPRINGS. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND / OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR # 960018. SALES SVC CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO. TRAINING REQUIRED? NO.
THE SURGEON REVISED THE CUP BECAUSE OF A BROKEN FIN ON THE CUP AND A LOOSE LINER. LINER CATALOG #6728-03 LOT #48421000.
PN 3/2/95 AN IPP DEVICE WAS IMPLANTED. ON 8/4/95 THE CYLINDER AND PUMP WAS REVISED. ON 26/96 THE CYLINDERS WERE REVISED. ON 8/21/96 THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-RIGHT CYLINDER.
CYLINDER WAS FUNCTIONAL. CYLINDER HAD A FATIGUE AND WEAR LEAK.
DEVICE WAS REMOVED FROM THE PT DUE TO PAIN, WOULD NOT DEFLATE AND REPLACED.
PUMP PERFORMED WITH SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. TUBING HAD OR DAMAGE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR (EXTRAPERITONEAL). IT WAS REPORTED BY THE REP THAT THE RPTR CUT DOWN TO THE PRE-PERITONEAL SPACE AND USED FINGER DISSECTION TO EXPAND THIS SPACE. HE LUBRICATED AND INSERTED A BALLOON DISSECTOR AND PROCEEDED TO BLOW UP THE BALLOON. HOWEVER, THE BALLOON ONLY PARTIALLY INFLATED AND A CLEAR FIELD COULD NOT BE SEEN ON INSERTION OF THE LAPAROSCOPE. THE DISSECTOR WAS WITHDRAWN AND IT WAS OBVIOUS THE CAGE HAD BENT ON INSERTION. IN THE PROCESS, THE BALLOON HAD TORN AND THE PERITONEUM WAS TORN LEADING TO THE ABDANDONMENT OF THE LAPAROSCOPIC APPROACH. EXCESSIVE FORCE WAS NOT USED TO INSERT THE DEVICE. "THE CAGE BENT ON INSERTION CAUSING THE BALLOON TO TEAR."
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
THE OPERATOR TURNED ON THE DEFIB AND SET THE ENERGY SELECT SWITCH TO 3J, THINKING THAT IT WAS SET TO 200J BECAUSE THE OPPOSITE END OF THE POINTER ON THE SWITCH POINT TO 200J WHEN SET TO 3J. THE DEFIB WAS TESTED AT 3J. THE PADDLES WERE THEN APPLIED TO THE PT WITH 60 OHMS IMPEDANCE AND DELIVERED 3J. THE SWITCH WAS THEN MOVED TO 7J (THINKING IT WAS 360J). THE PADDLES WERE APPLIED WITH AN IMPEDANCE OF 53 OHMS AND 7J WAS DELIVERED. THE PT EXPIRED. THE UNIT WAS TESTED BY THE HOSPITAL'S BIO MED DEPT WITH NO TROUBLE FOUND. IT HAS BEEN RETURNED TO SVC IN THE EMERGENCY DEPT.
AN INTERNAL REPORT GENERATED AT THE HOSP REPORTEDLY FOUND THAT THE DEFIB WAS OK AND THAT USER ERROR HAD OCCURRED IN READING THE WRONG END OF THE ENERGY SELECT SWITCH. THE ER CLINICAL NURSE MANAGER REVIEWED THE FINDINGS AND PROPER OPERATING TECHNIQUE WITH THE CLINICAL STAFF.
LOCKING TAB ON METAL SHELL BROKE OFF CAUSING THE LINER TO BECOME DISPLACED.
OTHER DEVICE USED: CATALOG #00-6728-003-00 STANDARD LINER, LOT# 48421000. EVAL CODES FOR SECTION H6: 86-100 DEVICE WAS NOT RETURNED. THEREFORE NO EVAL COULD BE MADE. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNK OR IS NA. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
DURING A PTCA/STENT PROCEDURE OF A LEFT CIRCUMFLEX LESION, THE GUIDEWIRE TIP FRACTURED. AT THIS TIME, THE PHYSICIAN NOTED DYE EXTRAVASATION BUT DID NOT UNDERSTAND WHAT HAD OCCURRED. AFTER SOME DIFFICULTY WITH MOVEMENT, THE DR WAS ABLE TO DEPLOY THE STENT SUCCESSFULLY. UPON REMOVAL OF THE GUIDEWIRE FROM THE PT, IT WAS NOTED THAT A PERFORATION OF THE VESSEL HAD OCCURRED. THE PT EXPERIENCED CARDIAC TAMPONADE AND A PERICARDIAL TAP WAS PERFORMED. THE PT EXPIRED A FEW MINS LATER. THE DR HAD INDICATED THAT THE GUIDE WIRE WAS SUBJECTED TO SEVERAL PRESSURES BEFORE THE DEPLOYMENT OF THE STENT WHICH COULD HAVE EXPLAINED WHY THE TIP OF THE GUIDE WIRE FRACTURED. PHYSICIAN ALSO INDICATED THAT THE 90-YR-OLD PT MAY HAVE HAD FRAIL ARTERIES.
SECTION G. #4: QA DEPT DID NOT RECEIVE NOTIFICATION OF EVENT UNTIL 8/29/96.
DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. ANOTHER DEVICE WAS IMPLANTED. UNABLE TO OBTAIN ADD'L INFO.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDER.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS, CYLINDER WEAR NOTED, AND REPLACED.
PUMP HAD A FATIGUE LEAK. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD TORN FABRIC AND BULGING.
PT UNDERWENT POSTERIOR VAGINAL REPAIR 2 YRS AGO USING SURGICAL MESH. PRESENTED LAST WEEK WITH PELVIC MASS ENGULFING RIGHT URETER. HAD RESECTION OF FIBROTIC, RETROPERITONEAL MASS TRACED TO MESH.
DEVICE WAS REMOVED FROM THE PT AND REPLACED BECAUSE IT WAS NOT FUNCTIONING WELL.
A SCLERAL BURN OCCURRED NEAR END OF CASE WHEN USING PHACO HANDPIECE.
A CO SVC REP CHECKED THE SYSTEM AND 2 HANDPIECES AND FOUND EACH ITEM TO MEET ITS PERFORMANCE SPECS. PT INFO WAS REQUESTED, BUT NOT PROVIDED BY RISK MGMT. THIS REPORT SUBMITTED TO FDA ON 9/25/96. THE MFR INTERNAL REF # IS 9-8888-96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR5803, IN COMPLIANCE WITH THE MDR REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADDMISSION THAT AN CO'S PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
NOTE THAT THIS REPORT WAS RECEIVED BY PHARMACIA IOVISION ON 1/4/96. IT WAS BROUGHT TO THE ATTENTION OF CORPORATE PHARMACOVIGILANCE (CPV) ON 9/12/96 FROM SWEDEN. THE CONSULTANT OPINION OF THE REPORT WAS RECEIVED AT PHARMACIA IOVISION ON 7/16/96 AND FORWARDED TO CPV ON 9/27/96. THIS SHOULD CLARIFY MANUFACTRER RECEIVE DATES.
INVESTIGATION BY THE MFR CONSISTED OF A VIDEO THAT WAS REVIEWED AND EVALUATED BY A CONSULTANT. IT WAS THE OPINION OF THE CONSULTANT. IT WAS THE OPINION OF THE CONSULTANT THAT IT WAS APPARENT THAT THE PT SUSTAINED A "CAPSULAR BLOCK PHENOMENON". THIS COMPLICATION IS MORE RELATED TO CAPSULORHEXIS THEN IT IS TO ANY GIVEN LENS IMPLANT. THE OBSERVED SITUATION WAS CAUSED BY THE SURGICAL PROCEDURE. NO FURTHER INFO IS EXPECTED.
THE DEFIB PADS TORE AND THIS HAPPENED TO THREE DIFFERENT PADS DURING A CODE".
THIS EVENT OCCURRED BECAUSE OF DIFFICULTY OPENING THE PADS TO BE USED WITH THE DEFIBRILLATOR. THE OPERATION OF THE DEFIB ITSELF WAS NEVER IN QUESTION. THE M1749A PADS WERE FROM LOT NUMBER 970529. THESE PADS WERE FROM AFFECTED LOT NUMBERS WHICH HAD A PROBLEM. THE PROBLEM IS KNOWN AND A FIX IS IN PLACE. FAXED THE CUSTOMER A LETTER WITH THE LOT NUMBERS AND     RECOMMENDATIONS. CUSTOMER HAS A REPLACEMENT CASE OF PADS. AFTER TRYING SEVERAL SETS OF PADS IN THE ER, SOMEONE GOT A PACKAGE FROM THE ICU (DIFFERENT LOT CODE) WHICH OPENED IMMEDIATELY AND WAS APPLIED TO THE PT. THE ER, TEAM THEN PROCEEDED WITH THE DEFIBRILLATION. STATEMENT FROM RN, HEAD OF ER NURSING AT HOSP, INDICATES THAT IN HER OPINION THE PT WOULD HAVE DIED EVEN IF THERE HAD BEEN NO DELAY IN OPENING THE PADS. THE DELAY CAUSED FRUSTRATION FOR THE ER TEAM, BUT THE PT WOULD HAVE EXPIRED ANYWAY.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A FATIGUE AND WEAR LEAK. TUBING HAD OR DAMAGE.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDERS.
FOUR MONTHS AFTER IMPLANTATION, THE CATHETER SEPARATED AT THE POINT WHERE IT WAS POSITIONED BETWEEN THE FIRST RIB AND THE CLAVICLE. THE PROXIMAL END OF THE CATHETER WAS REMOVED UNDER ANGIOGRAPHIC CONTROL. THIS PIECE OF CATHETER WAS DISCARDED BY THE HOSP. THE PORT WAS REMOVED AND REPLACED. THERE WERE NO PT COMPLICATIONS.
FURTHER FOLLOW UP REVEALED THE PHYSICIAN BELIEVED THE CATHETER DETACHMENT WAS DUE TO NORMAL WEAR AND TEAR DUE TO THE LENGTH OF TIME THE PORT WAS IMPLANTED. NO PT COMPLICATIONS RESULTED FROM THIS EVENT. CO'S EVALUATION FOUND THAT THE INCIDENT WAS DUE TO DEVICE USE AND POSITIONING. THE INSTRUCTIONS FOR USE WARN THE PHYSICIAN AGAINST PLACING THE CATHETER IN A POSITION THAT COULD CAUSE CLAVICULAR SHEAR. CO'S CONCLUSION IS THAT IMPROPER PLACEMENT OF THE CATHETER CAUSED THIS INCIDENT.
ON 7/26/83 AN IPP DEVICE WAS IMPLANTED. ON 12/15/92 THE CYLINDERS WERE REVISED. ON 8/26/96 THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS-PUMP.
ALLEGEDLY INSERT WAS REVISED AND RETURNED TO MFR FOR EVALUATION. NO COMPLAINT STATED. ORIGINAL SURGERY: 12/5/90.
ADDITIONAL INFORMATION OBTAINED ON 10/14/96 INDICATES THE REASON FOR REMOVAL WAS INADEQUATE RIGIDITY.
RPTR ENCOUNTERED POOR VACUUM AND CHANGED UNIT. HANDPIECES AND CASSETTE 3 TIMES, AND EACH TIME THEY NOTICED NO IMPROVEMENT. POSTERIOR CAPSULE RUPTURED AND LENS FELL BACK INTO VITREOUS. PT WAS REFERRED TO ANOTHER DR AND WILL REQUIRE ADD'L SURGERY. AFTER 3RD UNIT, THEY PULLED LOT OF CASSETTES. CONTINUE TO USE ALL 3 UNITS WITHOUT INCIDENT.
A CO SVC REP CHECKED ALL 3 SYSTEMS AND FOUND THEY MET THEIR PERFORMANCE SPECS, BUT S/N 440 CASSETTES WERE RUBBING. THEY RECENTERED ONE CASSETTE  MECHANISM TO RESOLVE. NO INDICATION THAT EQUIPMENT PERFORMANCE CONTRIBUTED TO THE EVENT. THIS REPORT WAS MAILED IN TO FDA ON: 9/25/96. THE MFR INTERNAL REF # IS 8-8832-96.
VENTILATION TUBE SURGICALLY PLACED IN EAR 2/15/90, EXTRUDED 9/5/91, LEAVING HOLE IN TYMPANIC MEMBRANE, A LARGE HOLE WHICH NEVER HEALED OVER A GIVEN PERIOD OF TIME, UNDER MEDICAL SUPERVISION. PT NOW HAS MAXIMUM CONDUCTIVE HEARING LOSS AND MUST ALWAYS PROTECT FROM WATER CONTAMINATION. BONES OF HEARING ALSO MISALIGNED DUE TO HOLE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
ALLEGATIONS OF SYMPTOMS OF SYSTEMATIC LUPUS ERTHEMATOSIS, ARTHRALGIA, NIGHT SWEATS, NEUROLOGICAL SYMPTOMS INCLUDING COGNITIVE DYSFUNCTON, IMMUNE MEDIATED SKIN RASH, SICCA SYMPTOMS, NEUROPSYCHIATRIC SYMPTOMS, SEROLOGIC ABNORMALITIES, POLYARTHRITIS, RAYNAUD'S PHENOMENON AND RESTRICTIVE LUNG DISEASE.
AN ENDOMETRIAL ABLATION PROCEDURE WAS IN PROGRESS WHEN THE DOCTOR NOTICED THE WIRE CUTTING LOOP BEND BACKWARD ALMOST PARALLEL TO THE SHAFT. THE DOCTOR THEN STRAIGHTENED THE LOOP BACK TO A 90 DEGREE POSITION. UPON ACTIVATION OF CURRENT THE WIRE LOOP BROKE OFF AND THE UTERUS WAS PERFORATED. THE CASE WAS COMPLETED WITH SOME ADD'L LOOPS BEING BENT. A LAPAROTOMY WAS PERFORMED TO OVERSEW THE UTERUS. POST OPERATIVE RECOVERY OF THE PT IS NORMAL.
DATA FOR SECTION F. FILLED IN BY THIS MFR. THIS MFR'S REPRESENTATIVE VIEWED DEVICE AT USER FACILITY. USER FACILITY WILL NOT RETURN DEVICE. IT WAS NOTED THAT THE ENTIRE METAL LOOP SECTION WAS BROKEN OFF AT BOTH INSULATION POINTS. BENDING AND SUBSEQUENT RE-BENDING OF WIRE LOOP IN ALL PROBABILITY CAUSED WIRE TO FRACTURE PRIOR TO HF CURRENT ACTIVATION.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO INFECTION PUMP/SCROTUM.    9/27/96
ALLEGATIONS OF SCLERODERMA, ATYPICAL CONNECTIVE TISSUE DISEASE, ATYPICAL NEUROLOGIC DISEASE SYSTEM, NEUROMUSCULAR JUNCTION DISEASE, RHEUMATOID ARTHRITIS, DERMATOMYOSITIS, POLYARTHRITIS, MYALGIAS, NEUROPSYCHIATRIC SYMPTOMS, PERIPHERAL NEUROPATHY, CHRONIC FATIGUE, SLEEP DISTURBANCES, PERSISTENT LOW-GRADE FEVER, CHRONIC INFLAMMATORY RESPONSE, BREAST INFECTIONS, DISFIGUREMENT, IMPAIRMENT OF THE IMMUNE SYSTEM, COMPLEX, SURGICAL PROCEDURES, SCAR TISSUE CAPSULATION, AUTO-IMMUNE DISEASE, MEMORY LOSS, SKIN DISCOLORATION, HUMAN ADJUVANT DISEASE, DEPRESSION, SILICONE IMPLANT DISEASE.
INFO RECEIVED ON 8/27/96 INDICATES THE PT'S WIFE STATES "DEVICE IS NOT LASTING 15-20 YRS LIKE WE WERE PROMISED BY THE DR." A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.
REVISION SURGERY REVEALED POLYETHLENE WEAR AND SEPARATION OF THE PATELLA. THE TIBIAL INSERT EXHIBITED MINIMAL WEAR AND WAS PROPHYLACTICALLY REPLACED AT THS TIME.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVALUATION: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED TIBIAL INSERT WEAR AND PATELLAR DISASSOCIATION AS THEY HAVE NOT BEEN RETURNED HOWMEDICA. THE LOT CODES HAVE NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL.
DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. ANOTHER DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO.
A CORNEAL BURN OCCURRED. CONVERTED TO ECCE TO COMPLETE PROCEDURE. PT HAS SHALLOW CHAMBER POST-OP.
A COMPANY SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND 5 U/S HANDPIECES. ALL ITEMS WERE FOUND TO MEET THEIR PERFORMANCE SPECIFICATIONS, BUT HANDPIECE S/N IUHP056455 LJG HAS A BENT NOSECONE. THIS CONDITION IS UNRELATED TO EVENT. EVENT OCCURRED WEEK OF 9/13/96; SPECIFIC DATE UNKNOWN. THIS REPORT WAS MAILED IN TO FDA ON: 9/27/96. THE MFR'S INTERNAL REFERENCE NUMBER IS 9-8906-96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULS NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC, PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
ALLEGATIONS OF DEFORMITY OF BREAST, LEAKAGE, LOSS OF PHYSICAL VITALITY, JOINT PAIN, PERSISTENT FATIGUE AS WELL AS GENERALIZED PAIN AND SUFFERING, ALLEGEDLY MAY ALSO INCLUDE, RHEUMATOID ARTHRITIS, LUPUS, ERYTHEMATOUS PATCHES, TELANGIECTASIS, SCLERITIS, AND MENTAL ANGUISH.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO PAIN AND PT DISSATISFACTION-NON-FUNCTIONING PROSTHESIS.
ER NURSE INCURED NEEDLESTICK TO HAND AS HE PUSHED A SYRINGE INTO A CLEAR #4838C SHARPS CONTAINER, MOUNTED IN AN ALMOND CABINET. HE WAS STUCK BY A NEEDLE CAUGHT IN THE TORTUOUS PATH OF THE LID. TYPE OF NEEDLE AND SOURCE PT IT WAS USED ON ARE UNK. ALSO UNK, IS THE HEIGHT  CONTAINER WAS MOUNTER. IT IS UNK WHAT TYPE OF FIRST AID WAS GIVEN.
FROM INCIDENT INVESTIGATION WITH HOSP CONTACT PERSON, IT WAS DETERMINED THAT IT IS POSSIBLE THE ER NURSE PUSHED SYRINGE IN, INSTEAD OF LETTING IT DROP ON ITS OWN BECAUSE IT WAS TOO LARGE. IT IS ALSO POSSIBLE HE COULD NOT SEE IF OBJECTS WERE TRAPPED IN TORTUOUS PATH BECAUSE HEIGHT OF MOUNTING OR OPAQUENESS OF THE CABINET ABOVE THE FINE LINE, BUT BELOW LEVEL OF THE LID. THE TERRITORY MANAGER HAS RE-INSERVICED ACCOUNT AND SOME OF THE CABINETS HAVE BEEN LOWERED TO ALLOW THE END USER TO SEE OPENING OF CABINET MORE READILY. CUSTOMER HAS HAD NO FURTHER NEEDLESTICK INCIDENTS SINCE THIS WAS REPORTED AND IS SATISFIED WITH MFR'S RESPONSE. PLEASE NOTE THAT SECTION F WAS COMPLETED BY MFR.
REVISION SURGERY REVEALED POLYETHYLENE WEAR AND SEPARATION OF THE PATELLA. THE TIBIAL INSERT EXHIBITED MINIMAL WEAR AND WAS PROPHYLACTICALLY REPLACED AT THIS TIME.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVALUATION: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED TIBIAL INSERT WEAR AND PATELLAR DISASSOCIATION AS THEY HAVE NOT BEEN RETURNED TO HOWMEDICA. THE LOT CODES HAVE NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE,. ATTEMPTS TO OBTAIN THE DEVICE AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL.
DR REPORTS A FOLDING PROBLEM WITH THE LENS WHICH NECESSITATED THE WOUND BE WIDENED.
NO ADD'L INFO HAS BEEN RECEIVED FROM RPTR DESPITE REQUEST. ANALYSIS RETURNED LENS REVEALED NO DEFECTS AND PRODUCT WAS FOUND TO BE WITHIN SPECS. MFR'S CONCLUSION IS THAT THERE WAS NO FAILURE OF THE DEVICE. THE MFR'S INTERNAL REF # IS 96L3707. THIS REPORT WAS MAILED IN TO FDA ON: 9/25/96, DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR802, IN COMPLIANCE WITH THE MDR REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN CO'S PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. # OF PERSON AFFECTED = 1.
ALLEGES GEL MIGRATION, GEL BLEED, JOINT PAIN, MUSCLE PAIN, EXTREME FATIGUE, MEMORY LOSS, RASHES AND ELEVATED SED RATE.
DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
A CORNEAL BURN OCCURRED. NO INTERVENTION REPORTED.
A COMPANY SERVICE REP CHECKED THE SYSTEM AND 5 HANDPIECES. ALL ITEMS FOUND TO MEET THEIR PERFORMANCE SPECIFICATIONS, BUT HANDPIECE S/N IUHP056455 LJG HAS A BENT NOSECONE. THIS CONDITION IS UNRELATED TO EVENT. THIS REPORT WAS MAILED IN TO FDA ON: 9/27/96. THE MFR'S INTERNAL REFERENE NUMBER IS 9-8906B-96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE TECHNOLOGIST TRIPPED OVER THE POWER AND VIDEO CABLE WHEN GOING TO THE BACK OF THE MONITOR CART. APPARENTLY THE TECHNOLOGIST FELL AND BROKE THEIR ELBOW.
ALLEGES CHRONIC FATIGUE, SLEEP DISORDER, HEADACHES, MITRAL VALVE PROLAPSE, PERIPHERAL NEUROPATHY, JOINT PAIN, RAYNAUD'S PHENOMENA, MEMORY LOSS, CONCENTRATION DISORDER, GEL BLEED, AND GEL MIGRATION.
A CORNEAL BURN OCCURRED DURING PROCEDURE. CHANGED TO ECCE TO COMPLETE CASE.
A COMPANY SERVICE REP CHECKED THE SYSTEM AND THE HANDPIECE, S/N IUHP180970, AND FOUND THEM TO MEET THEIR PERFORMANCE SPECIFICATIONS. NO CONSUMABLES WERE SAVED FOR EVAL. PT INFO WAS REQUESTED, BUT NO INFO WAS PROVIDED. THIS REPORT WAS MAILED IN TO FDA ON: 9/27/96. THE MFRS INTERNAL REFERENCE NUMBER IS 9-8837-96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE FOR HAS CAUSED SERIOUS INJURY.
PT REPORTS SHE SUFFERS FROM CHRONIC FATIGUE/EXHAUSTION AND CHRONIC SEVERE NECK PAIN WITH HEADACHES.
FEMALE NURSE EXPERIENCED A FINGER NEEDLESTICK INJURY WHEN DISPOSING A SYRINGE INTO A #4838C CONTAINER OPENING MOUNTED IN AN ALMOND CABINET IN THE OR. THE NURSE DID NOT NOTICE SYRINGE CAUGHT ON THE TORTUOUS PATH FLAP THAT WAS POINTING UPWARD AND WAS STUCK BY THE NEEDLE AS SHE PLACED HER HAND CLOSE TO THE OPENING TO DISPOSE OF ANOTHER NEEDLE. IT IS UNK WHAT TYPE OF FIRST AID, IF ANY, WAS PROVIDED, ALTHOUGH, THINKS AN INCIDENT REPORTED WAS WRITTEN.
AN INCIDENT INVESTIGATION DETERMINED THAT THE CONTAINER WAS MOUNTED APPROX 4 1/2 FEET FROM THE FLOOR. ALTHOUGH THE INITIAL REPORT INDICATED THE CONTAINER WAS FULL, FURTHER INVESTIGATION INDICATED IT WAS ONLY 25% FILLED WITH SHARPS; ADD'L ATTEMPTS TO FURTHER INVESTIGATE ON 8/1/96 AND 9/8/96 WERE UNSUCCESSFUL BECAUSE THE ORIGINAL CONTACT IS NO LONGER AT THE FACILITY AND NO OTHER CONTACT PERSON COULD BE DETERMINED. THE TERRITORY MANAGER WAS THE SOURCE OF THE ABOVE INFORMATION. IT WAS REPORTED THAT THE ER & OR STAFF DO NOT LIKE THE CONTAINERS BECAUSE THEY CANNOT SEE WHEN CONTAINER IS FULL. PLEASE NOTE THAT SECTION F WAS COMPLETED BY MFR.
INOF RECEIVED ON 8/27/96 INDICATES DEVICE WAS REMOVED FROM THE PT DUE TO A MALFUNCTIONING PROSTHESIS. NO RECORD OF PREVIOUS IMPLANT DATE OF BRAND. CO HAS REQUESTED ADD'L INFO.
LENS WAS REMOVED DUE TO CORNEAL TOUCH AND THE HAPTIC HAD GROWN INTO THE IRIS.
THE LENS WAS RETURNED TO THE MFR AND EVALUATED. BOTH HAPTICS WERE EVALUATED TO BE BROKEN. HOWEVER, IT IS QUITE POSSIBLE THAT THE HAPTICS WERE BROKEN DURING REMOVAL FROM THE EYE DUE TO THE NATURE OF THE PROBLEM. THIS REPORT WAS MAILED IN TO FDA ON: 1/24/97.
A 2+ CORNEAL BURN OCCURRED DURING THE PROCEDURE. USED SUTURES TO CLOSE.
COMPANY REP WAS PRESENT DURING PROCEDURE. DISCUSSED SETTING CHANGES AND PRODUCT FEATURES WITH DR. NO PRODUCT AVAILABLE FOR EVAL. USED U/S HANDPIECE WITH SERIAL NUMBER IUHP056324, AND CUSTOM PAK 20111, LOT NUMBER UNKNOWN. THIS REPORT WAS MAILED IN TO FDA ON: 9/27/96. THE MFR'S INTERNAL REFERENCE NUMBER IS 9-8841-96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
A PENILE PROSTHESIS WAS IMPLANTED, PRODUCT TYPE AND DETAILS NOT INDICATED. ON 8/19/96 THE PENILE PROSTHESIS WAS REMOVED FROM THE PT DUE TO INFECTION-PENILE SCROTAL. CO HAS REQUESTED ADD'L INFO.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT AN ANOTHER DEVICE IMPLANTED DUE TO "MALFUNCTIONING".
ON 9/9/96, THE FACILITY CONTACTED A MFR REP AND REPORTED A NUMBER OF ISSUES REGARDING DEVICE ACCESS. IT WAS STATED THAT THE PT CAME TO THE FACILITY FOR THERAPY, AT WHICH TIME A 3/4" INFUSION SET WAS USED. THE NURSE REPORTEDLY HAD TO HOLD DOWN THE INFUSION SET DURING INFUSION. IT WAS NOTED THAT THE NEEDLE MAY HAVE BEEN TOO SHORT. ON ANOTHER DAY, THE PT WAS ACCESSED AND THERE WAS DIFFICULTY FINDING THE DEVICE. THE FACILITY SUPERVISOR ASSISTED AND WAS ABLE TO ACCESS THE DEVICE AND OBTAIN A BLOOD RETURN. DURING THE NEXT ATTEMPT TO ACCESS THE DEVICE, THE DEVICE SEPTUM COULD NOT BE LOCATED. THERE IS A POSSIBILITY THAT THE DEVICE MAY HAVE MOVED OR FLIPPED.
FURTHER COMMUNICATION VIA THE MFR REP, ON 9/24/96, REVEALED THAT THE FACILITY NURSE HAD A CONSULTATION WITH THE PT'S FAMILY DURING THE WEEK OF 9/16/96. IT WAS STATED THAT THE FACILITY HAS NOT HAD ANY PROBLEMS FLUSHING THE DEVICE AND THAT SHE WOULD CONTACT THE MFR IF ANY FURTHER PROBLEMS AROSE. IT WAS ADDITIONALLY STATED THAT THE DIFFICULTIES EXPERIENCED ARE BELIEVED TO HAVE BEEN RELATED TO NURSING TECHNIQUE AND NOT TO THE DEVICE. AS PART OF CO'S INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE FACILITY NURSE REQUESTED THAT CO'S FINDINGS BE FAXED TO HER ATTENTION SO THAT SHE CAN ADD THEM TO THEIR FILE CREATED BY THE PRODUCT REVIEW COMMITTEE. BASED ON THE INFO AVAILABLE THIS EVENT DOES NOT APPEAR TO BE ATTRIBUTABLE TO THE DEVICE OR A DEVICE MALFUNCTION. THE DEVICE REMAINS IMPLANTED AT THS TIME FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
A "BIG LEAK IN VALVE", SEVERE REGURGITATION.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A NON-FUNCTIONING DEVICE.
RECEIVED LETTTER FROM CONSUMER WHO STATED HER DAUGHTER WAS DIAGNOSED BY A PHYSICIAN AS HAVING TSS.
PRODUCT NOT RETURNED TO MFR. CO IS SUBMITTING THIS REPORT ONLY BECAUSE IT BELIEVES THAT AN EVENT WHICH MEETS THE REQUIREMENTS OF 21 C.F.R. PART 803 MAY HAVE OCCURRED. THIS DOES NOT MEAN THAT CO BELIEVES THE DEVICE MFG OR IMPORTED BY CO MAY BE DEFECTIVE OR HAS MALFUNCTIONED, OR THAT A CO'S PRODUCT WAS IN FACT ASSOCIATED WITH AN ACUTAL CONSUMER INJURY. CONSEQUENTLY, THIS REPORT MUST NOT BE CONSTRUED AS AN ADMISSION OF ANY KIND BY CO.
THIS EVENT WAS REPORTED AS ENDOCARDITIS. NO FURTHER INFO AVAILABLE. DATE DEVICE EXPIRES: 5/1/2000.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT DUE TO FLUID LOSS-RIGHT CYLINDER AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE AND WEAR LEAK.
RPTR'S WIFE USED ONLY 2 TAMPONS, EACH AT THE END OF HER MENSTRUAL CYCLE FOR THE LAST TWO MONTHS. EACH TIME SHE EXPERIENCED SEVERE, DEBILITATING ITCHING. CALLED THE "800" NUMBER FOR THE CO AND WAS TOLD TO QUIT USING THE PRODUCT. MFR SAID THEY WOULD LIKE THE PRODUCT TO TEST. PT CONSULTED HER DR.
INFO ON A MEDICAL DEVICE REGISTRATION FORM INDICATED THAT ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM DISTAL TO AN EXISTING STENT IN THE SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL BRANCH RESULTED IN EMBOLIZATION OF THE STENT. THE DELIVERY SYSTEM WAS WITHDRAWN AND A SECOND GUIDEWIRE WAS USED TO ASSIST IN THE RETRIEVAL OF THE EMBOLIZED STENT. WHEN THE GUIDEWIRES WERE WITHDRAWN, THE STENT WAS NOTED TO HAVE EMBOLIZED PERIPHERALLY. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN NATIVE CORONARY PROCEDURES ONLY. PRODUCT LABELING RECOMMENDS THAT WHEN TREATING MULTIPLE LESIONS, THE DISTAL LESION SHOULD BE INITIALLY STENTED, FOLLOWED BY STENTING OF THE PROXIMAL LESION.
THIS EVENT WAS REPORTED AS "MITRAL VALVE DISORDER". NO FURTHER INFO PROVIDED.
THE NURSE EXPERIENCED A PUNCTURE TO HER INDEX FINGER WHICH CAUSED MINIMAL INJURY WHEN SHE WENT TO DROP A SYRINGE INTO A LESS THAN FULL#4838C SHARPS CONTAINER PLACED INSIDE AN ALMOND CABINET. #4842. SHE WAS STUCK BY A NEEDLE THAT HAD NOT DROPPED THROUGH THE TORTUOUS PATH LID AND WAS STICKING UP. SHE WAS THEN TAKEN TO THE ER WHERE SHE RECEIVED  FIRST AID FOR THE INJURY AND TREATED PER THE HOSP'S POLICY FOR EXPOSURE TO BLOOD PATHOGENS.
INVESTIGATION OF THIS NEEDLESTICK INCIDENT INDICATED THE CONTAINER, WHICH WAS LOCATED IN A MED-SURG UNIT, WAS DESCRIBED AS BEING "LESS THAN HALF FULL"' BUT "SEVERAL SHARPS COLLECTED IN THE TOP OF THE INSERT".  IT IS BELIEVED THAT THE SHARPS ARE NOT DROPPING INTO THE CONTAINER. THE CONTAINERS APPEAR FULL, BUT WHEN HOUSEKEEPING CHANGES THEM, THEY FIND SHARPS STUCK IN THE TOP. IT WAS NOT VERIFIED, BUT IT IS BELIEVED THAT INSULIN SYRINGE CAUSED THE INJURY. THE SOURCE PT THAT NEEDLE WAS USED ON WAS NOT KNOWN. THE BASE OF THE CONTAINER WAS MOUNTED ABOUT 3 1/2 FEET FROM THE FLOOR, AND THE NURSE WAS ABLE TO SEE THE OPENING OF THE CONTAINER. PLEASE NOTE THAT SECTION F WAS COMPLETED BY THE MFR.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. CONNECTOR WAS FUNCTIONAL.
THIS EVENT WAS REPORTED AS "DEGENERATION." NO FURTHER INFO AVAILABLE.
DURING A DIALYSIS TREATMENT, THERE WAS WEIGHT GAIN. PT WAS ADMITTED TO THE HOSP WITH PULMONARY EDEMA. THE UF (ULTRAFILTRATION) PUMP WAS REPLACED.
AN MES (MEDICAL EQUIPMENT SERVICE) TECH EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE, SINCE THE RETURNED UF PUMP HAD NO TRACEABILITY STICKER ATTACHED TO IT. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RECEIVED BY THE MFRFOR TESTING ON 9/27/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER READ OL, INDICATING THAT THE THERMAL FUSE HAD OPENED (FAILED). THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
MFR'S RESPONSE RECEIVED ON 4/30/97: THE INFO PROVIDED DID NOT PRESENT ANY EVIDENCE TO IDENTIFY ANY MALFUNCTION OF THE MASK. THE MASK IS NOT SOLD WITH TUBING, WHICH WAS IDENTIFIED AS THE CAUSE OF THE DEATH. THE TRACHEOSTOMY MASK DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PT. NO CORRECTIVE ACTION WILL BE TAKEN AS NO PROBLEMS WERE IDENTIFIED WITH THE MASK IN THE REPORT. THIS INVESTIGATION IS CLOSED.
THIS EVENT WAS REPORTED AS STENOSIS. NO FURTHER INFO AVAILABLE.
CODE: 86: EVAL OF INCIDENT BASED ON HISTORY OF DEVICE AND CONTENT OF  INCIDENT DESCRIPTION. THIS INFO WAS RECEIVED AS A CUSTOMER COMPLAINT.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO THE PT DOING A SELF CATH CAUSING EROSION AND INFECTION.
PUMP WAS FUNCTIONAL. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS. CUFF HAD OR DAMAGE.
DILATOR HAS OBSTRUCTION. COULD NOT PASS GUIDE WIRE THROUGH.
THE BALLOON AND PUMP WERE REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
PUMP READING LOW BATTERY. EVEN THOUGH THE PUMP WAS PLUGGED IN. COULD NOT GET IT TO RUN AGAIN.
THE CUFF WAS REMOVED FROM THE PT, REASON NOT INDICATED, AND REPLACED. CO HAD REQUESTED ADD'L INFO.
A NURSE EXPERIENCED A NEEDLE STICK INJURY WHEN SHE TRIED TO DROP A SYRINGE INTO A SHARPS CONTAINER ENCLOSED IN A #4842 ALMOND CABINET. FIVE NEEDLES WERE POINTING UP OUT OF THE LID AND THE NURSE WAS STUCK BY ONE THEM. THE NURSE IS 5'2" TALL AND THE LID OF THE CONTAINER WAS ABOUT 5'8" HIGH, THEREFORE SHE DID NOT SEE THE NEEDLES STICKING OUT. IT IS UNK WHAT, IF ANY, FIRST AID TESTS OR MONITORING OF THE EMPLOYEE WAS PROVIDED.
INVESTIGATION BY THE SALES REP INDICATED THE CONTAINER WAS NOT OVERSTUFFED, BUT THE NEEDLES SEEMED TO BE CLOGGED AT THE TOP OF IT. AN ATTEMPT TO GET FURTHER INFO ABOUT THE NURSE WAS UNSUCCESSFUL. THE HOSP CONTACT INFORMED THE CO REP THAT FURTHER INFO WAS CONFIDENTIAL AND COULD NOT BE DISCLOSED. HE PROVIDED THE NAME OF THE QA DIRECTOR. THE SALES REP WAS RECOMMENDED TO RE-INSERVICE ACCOUNT TO ENSURE THE CONTAINERS ARE MOUNTED AT PROPER HEIGHT TO ALLOW NURSES TO SEE INSIDE LID, OR REPLACE ALMOND CLEAR FOR BETTER VISIBILITY OF CONTENTS. PLEASE NOTE THAT SECTION F WAS COMPLETED BY THE MFR.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE NUMBER WAS UNAVAILABLE FROM THE DR.
REVISION SURGERY DUE TO ASEPTIC LOOSENING WITH PERIPROSTHETIC FEMORAL FRACTURE.
THIS REPORT IS BEING AMENDED TO INCLUDE INFORMATION ABOUT SECTION F. SECTION F10 WAS NOT COMPLETED BECAUSE INFORMATION WAS PROVIDED BY ONE OR MORE CONSUMERS AND SPECIFIC DETAILS ABOUT THE USER FACILITY OR HEALTHCARE PROFESSIONAL WERE NOT AVAILABLE AT THE TIME OF THIS REPORT.
BALLOON WOULD NOT INFLATE DURING PRE-INSERTION TESTING.
ON 11/25/92 AN AUS DEVICE WAS IMPLANTED. ON 2/2/94 THE BALLOON WAS REVISED. ON 12/21/95 THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
THIS EVENT WAS REPORTED AS "DYSFUNCTION". NO FURTHER INFORMATION AVAILABLE.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO CHRONIC URINARY RETENTION AND INCONTINENCE DURING SEXUAL INTERCOURSE.
THIS EVENT WAS REPORTED AS REGURGITATION. NO FURTHER INFO AVAILABLE.
TWO ABUTMENTS BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT ASPRIOR MDR REPORTS #M441321 AND M734439.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENTS THEMSELVES. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORIES OF THE SUBJECT PRODUCTS COULD NOT BE COMPLETED SINCE THE LOT NUMBERS WERE UNAVAILABLE FROM THE DR.'S OFFICE.
RPTR HAD A NEW CT SCAN AND IT SHOWS THAT THERE IS A DURAL LEAK AND A PUNCTURE IN HIS CRANIUM; HE HAS HAD CONSTANT PAIN AND SUFFERING WITH THIS OPERATION. HEARING AIDS WERE IMPLANTED IN 12/5/75.
DURING A ROUTINE PT FOLLOW-UP WHILE ATTEMPTING TO INTERROGATE THE ICD, THE ERROR MESSAGE "CRYSTAL FAILURE" APPEARED ON PROGRAMMER SCREEN AND REAL TIME MEASUREMENTS SHOWED A PACING IMPEDANCE OF LESS THAN 100 OHMS. SURGERY WAS PERFORMED ON 8/28/96, TO EXPLANT THE ICD. AT THAT TIME, THE IMPEDANCE MEASUREMENTS READ GREATER THAN 2000 OHMS AND R WAVES STATED "PACED RHYTHM". THE ICD WAS PROGRAMMED TO PACE THE PT AT 50 BPM BUT NO PACER ARTIFACT WAS SEEN ON THE ELECTROGRAMS. THE CHRONIC LEAD SHOWED R WAVES OF 12 MILLIVOLTS AND A LEAD IMPEDANCE OF 480 OHMS.
THE HOSP HAS NOT CONFIRMED WHETHER A REPORT WAS SENT TO FDA. THE LEAD IMPEDANCE MEASUREMENT ANOMALIES WERE DUE TO INSUFFICIENT CRYSTAL AMPLITUDE. WHEN TESTED BY ITSELF, THE CRYSTAL PRODUCED A SUFFICIENTLY HIGH AMPLITUDE TO ALLOW COMMUNICATION WITH A PROGRAMMER. TESTING INDICATES THAT THE EPOXY WHICH ATTACHES THE CRYSTAL TO THE SUBSTRATE ASSEMBLY MAY HAVE CAUSED THE LOW AMPLITUDE.
A NURSE WAS PLACING A USED NEEDLE INTO A SHARPS CONTAINER HOUSED IN AN ALMOND CABINET WHEN SHE RECEIVED A PUNCTURE WOUND TO HER RIGHT, SECOND FINGER FROM ANOTHER NEEDLE STICKING OUT OF THE CONTAINER. THE CONTAINER WAS NOT FULL, BUT THE NEEDLE DIDN'T DROP INTO THE CONTAINER. AN INCIDENT REPORT WAS FILED.
INVESTIGATION INDICATED THAT THE FILL LINE IS NOT VISIBLE AT EYE LEVEL. THE NURSE WAS INSTRUCTED BY FACILITY TO BE MORE CAREFUL TO PREVENT RECURRENCE. PLEASE NOTE THAT SECTION F WAS COMPLETED BY THE MFR.
THIS EVENT WAS REPORTED AS "DYSFUNCTION" & CHRONIC ATRIAL FIBRILATION. NO FURTHER INFO AVAILABLE.
THE AUS DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED, AND REPLACED. CO HAS REQUESTED ADD'L INFO.
A VIDEO MONITOR THAT HAD BEEN INSTALLED RECENTLY IN THE CENTER HAD A MALFUNCTIONING VERTICAL HOLD. THERE WAS POTENTIAL DANGER TO THE PT BECAUSE THIS IS THE ONLY METHOD OF VIEWING THE INSIDE OF THE COLON DURING A PROCEDURE. THE SCREEN ON THE VIDEO MONITOR IS USED TO DIRECT THE PHYSICIAN DURING THE PROCEDURE. NO APPARENT INJURY OCCURRED TO THE PT DURING THE PROCEDURE.
AN AUS DEVICE WAS IMPLANTED ON 4/10/96. THE PUMP WAS REVISED ON 6/3/96. THE CUFF WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE ON 8/21/96 AND REPLACED.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORTS #M476658, M589908, M718808, AND M758905.
NO OBSERVABLE DEFORTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS COMPLETED AND FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
REVISION SURGERY DUE TO PAIN AND X-RAYS INDICATED SEVERE OSTEOLYSIS.
THIS REPORT IS BEING AMENDED TO INCLUDE INFORMATION ABOUT SECTION F. SECTIONF WAS NOT COMPLETED BECAUSE INFORMATION WAS PROVIDED BY ONE OR MORE CONSUMERS AND SPECIFIC DETAILS ABOUT THE USER FACILITY OR HEALTHCARE PROFESSIONAL WERE NOT AVAILABLE AT THE TIME OF THIS REPORT.
A VIDEO MONITOR THAT HAD BEEN INSTALLED RECENTLY IN THE CENTER HAD A MALFUNCTIONING VERTICAL HOLD. THERE WAS POTENTIAL DANGER TO THE PT BECAUSE THIS IS THE ONLY METHOD OF VIEWING THE INSIDE OF THE COLON DURING A PROCEDURE. THE SCREEN ON THE VIDEO MONITOR IS USED TO DIRECT THE PHYSICIAN DURING THE PROCEDURE. NO APPARENT INJURY OCCURED TO THE PT DURING THE PROCEDURE.
THIS EVENT WAS REPORTED AS INSUFFICIENCY. NO FURTHER INFO PROVIDED.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO NOT BEING ABLE TO     ACTIVATE THE DEVICE.
RPTR STATES THAT FACILITY IS EXPERIENCING SOFTWARE WITH DEVICE AND THE SYSTEM IS LOCKING OUT. FACILITY WANTS THE MFR TO SEND NEW SOFTWARE.
METHOD (86): PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM LAB.
ON 3/21/91 THE CUFF WAS IMPLANTED. ON 5/16/91 THE BALLOON AND PUMP WERE IMPLANTED. ON 11/2/91 THE BALLOON AND PUMP WERE REVISED. ON 7/22/96 THE BALLOON AND CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS.
ASSISTANT DIRECTOR OF HOUSKEEPING EXPERIENCED A NEEDLE STICK WHEN DISPOSING OF WHAT APPEARED TO BE A FULL SHARPS CONTAINER FROM A #4842 CABINET. A STAFF MEMBER STATED THAT THE 5 QUART TRANSLUCENT CONTAINER INSIDE THE CABINET APPEARED TO BE FULL AND THAT SYRINGES AND NEEDLES WERE JAMMED WITHIN THE CLEAR TORTUOUS PATH LID OF THE CONTAINER. WHEN THE EMPLOYEE WENT TO OPEN THE CABINET TO CHANGE THE CONTAINER, A NEEDLE FELL OUT OF THE LID FROM THE CABINET AND SHE INCURRED THE NEEDLE STICK. ACCOUNT REPORTED THAT A NEEDLE WAS HANGING UP IN THE TORTUOUS PATH AND OTHERS WOULD GET STUCK BEHIND IT. THIS GAVE THE IMPRESSION THE CONTAINER WAS FULL WHEN IT WAS NOT. IT IS UNK WHAT FIRST AID, TESTS, OR MONITORING, IF ANY, WAS GIVEN TO EMPLOYEE.
PLEASE NOTE THAT SECTION F COMPLETED BY THE MFR.
OTHER DEVICES USED: CATALOG #00-5780-041-08 ARTICULATING SURFACE, LOT UNKNOWN. EVAL CODE FOR SECTION H6: 86. A DIMENSIONAL CHECK WAS PERFORMED AND A COMPLAINT HISTORY FOR ADVERSE TRENDS WAS CONDUCTED. 100: DAMAGE TO DEVICE SUGGEST MALTRACKING OF COMPONENTS. EVENT FREQUENCY IS NOT ADDRESSED IN PRODUCT LABELLING. IT IS UNKNOWN IF EVENT OCCURRING MORE FREQUENTLY THAN USUAL. EVENT SEVERITY IS NOT ADDRESSED IN PRODUCT LABELLING. DATA TO DETERMINE LABELLED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
DURING AN ATTEMPT TO PLACE THE PORT ON THE PT'S RIGHT SIDE, A BURR WAS FOUND ON THE INTRODUCER, THIS IS SAID TO HAVE LACERATED THE PT'S VENA CAVA. THE PT SUFFERED A PNEUMOTHORAX AND A THORACTOMY WAS PERFORMED. THE PT LATER EXPIRED.
INFORMATION ACQUIRED ON 10/7/96 INDICATES THE REASON AS INADEQUATE BALLOON PRESSURE. UNABLE TO OBTAIN ADDITIONAL INFORMATION.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS NOT COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE MD'S OFFICE.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS AND INCONTINENCE.
THE DEVICE WAS RETAINED BY THE HOSPITAL. NICKS OR BURRS ARE USUALLY A RESULT OF STRIKING THE TIP OF THE INTRODUCER ON THE CLAVICLE OR OTHER HARD OBJECT DURING ATTEMPTED USE. WITHOUT THE DEVICE TO EVALUATE, NO CONCLUSION IS POSSIBLE.
CUFF PERFORMED WITHIN SPECIFICATIONS. PUMP/TUBING JUNCTION HAD FATIGUE AND WEAR LEAK.
THE PT EXPIRED 10 DAYS POST AORTIC VALVE IMPLANT WITH CONCOMMITANT CABG X 1. PT DEVELOPED MESENTERIC ISCHEMIA DUE TO EMBOLI, AND RENAL FAILURE 3 DAYS POST OPERATIVE AND ALSO EXPERIENCED A CVA ON THE 4TH DAY POSTOPERATIVE. NATIVE AORTIC ROOT NOTED TO BE VERY CALCIFIED DURING IMPLANT. PT 86 YEARS OLD AT TIME OF IMPLANT.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY DEATH THAT MAY HAVE OCCURRED". H11. F10 CODES: PT CODE # 1830- LABELED , #1770-LABELED, 1802- LABELED. DEVICE CODE #2204-NOT LABELED. EVALUATION CODE #86 OTHER=DEVICE HISTORY RECORD REVIEWED. NO MEDWATCH FORM WAS REC'D FROM THE USER FACILITY THEREFORE THE INFO ON THIS MEDWATCH FORM 3500A WAS COMPLETED BY MEDTRONIC WITH INFO PROVIDED BY THE MD. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A WAS COMPLETED BY MEDTRONIC WITH INFO PROVIDED BY THE MD. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A". ANALYSIS: AS THE PRODUCT WAS NOT EXPLANTED FOR RETURN ANALYSIS IT IS NOT POSSIBLE TO DETERMINE A DEVICE RELATED PROBLEM HOWEVER, THE DEVICE HISTORY FOR THIS PRODUCT WAS REVIEWED AND FOUND TO MEET ALL SPECS AT THE TIME IT WAS RELEASED FOR CLINICAL USE. THE EVENT REPORTED IS A KNOWN COMPLICATION WITH INCREASED RISKS CONTRIBUTED TO PT CONDITION. NO CONCLUSION CAN BE DRAWN.
THE CATHETER WAS PLACED 9/27/94 FOR INFUSIONS. THE PT USED THE CATHETER AT LEAST ONCE A DAY. THE CATHETER HAD ORIGINALLY BEEN PLACED IN THE CENTRAL VENA CAVA, BUT THEN MIGRATED TO THE AXILLARY VEIN. THE PT DEVELOPED PHLEBITIS AND THE CATHETER WAS REMOVED.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AND REPLACED.
CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS. PUMP/TUBING JUNCTION HAD FATIGUE AND WEAR LEAK.
THE DEVICE WAS REMOVED DUE TO "NON-FUNCTION". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A CO'S 3-PIECE INFLATABLE PENILE PROSTHESIS.
EVALUATION IS PENDING DECONTAMINATION, EXAMINATION AND TESTING OF THE RETURNED DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENCT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVALUATION WILL BE FORWARDED UPON COMPLETION.
THE CATHETER WAS RETURNED WITHOUT THE DISTAL TIP. UNDER MAGNIFICATION, A BROWN AND YELLOW CRYSTALLINE RESIDUE WAS FOUND INTERMITTENTLY DOWN THE LENGTH OF THE CATHETER. THE CATHETER LUMEN FLUSHED AND ASPIRATED NORMALLY. THE CATHETER WAS PRESSURIZED BY OCCLUDING THE DISTAL END AND ATTEMPTING TO FLUSH THE CATHETER WITH A SYRINGE. NO LEAKS WERE DETECTED. AN INJECTION CAP WAS FITTED TO THE CONNECTOR AND THE CATHETER WAS AGAIN PRESSURIZED. AGAIN, NO LEAKS WERE PRODUCED.
AFTER A CYSTOSCOPY BLADDER STONE FRAGMENTING PROCEDURE WHILE THE PT WAS STILL UNDER GENERAL ANESTHETIC, IT WAS NOTED THAT THE PT HAD A DISTENDED ABDOMEN. CYSTOGRAM WAS PERFORMED AND REVEALED PERFORATION AT POSTERIOR BLADDER WALL. LAPAROTOMY WAS PERFORMED TO REPAIR PERFORATION. SMALL PORTION OF BLADDER CALCULUS RETRIEVED FROM RETROPERITONEAL AREA.
1) UNIT WAS MFG ON 3/91 AND HAS NEVER BEEN RETURNED FOR SERVICE OR REPAIR. 2) UNIT FUNCTIONS PROPERLY. CO ALSO MEASURED THE INTENSITY OUTPUT AND THE RESULTS MET THE SPECS. 3) ACCORDING TO THE USER, IT WAS A VERY HARD STONE TO BREAK. AS A CONSEQUENCE, THE DR TURNED THE POWER OF THE DEVICE TO MAXIMUM SETTING. THE DR THEN NOTED A LOUD SOUND, SIGNIFYING THE BREAKAGE OF THE STONE. IT WAS THE DR'S BELIEF THAT A FRAGMENT FROM THE STONE PERFORATED THE BLADDER WALL.
THE DEVICE WAS REMOVED DUE TO A "FLUID LOSS". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER INFLATABLE PENILE PROSTHESIS.
THE ENTIRE DEVICE WAS RECEIVED AND EVALUATED BY THE MANUFACTURER. TWO LEAKAGE SITES WERE IDENTIFIED ON ONE OF THE CYLINDERS. ONE EXISTED AT THE STRAIN RELIEF JUNCTION. THE OTHER, WAS LOCATED IN THE CYLINDER BLADDER. A MICROSCOPIC EXAMINATION OF THE LEAKAGE SITES WAS PERFORMED. THE LEAKAGE SITE AT THE STAIN RELIEF JUNCTION WAS EXAMINED. THE INNER AND OUTER LAYER OF TUBING WERE SEPARATED. THE CROSS SECTIONAL SURFACES OF THIS LEAKAGE/SEPARATION SITE WERE ROUGH AND IRREGULAR, INDICATING A TEAR. THE BLADDER MATERIAL WAS SEPARATED. THE CROSS SECTIONAL SURFACES OF THIS LEAKAGE/SEPARATION SITE SHOWED UNIFORM STRIATIONS, INDICATING CONTACT WITH SHARP INSTRUMENTATION, E.G. SCALPEL, SCISSORS. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCE'S EXAMINATION, QA CONCLUDES THAT THE DEVICE LEAKED FROM THE TWO MENTIONED AREAS. BASED ON THE DURATION THE DEVICE WAS IMPLANTED, THE LEAKAGE SITE CAUSED BY INSTRUMENT CONTACT MOST LIKELY OCCURRED DURING OR SUBSEQUENT TO EXPLANT SURGERY. THE LEAKAGE SITE IN THE TUBING AREA WAS CAUSED BY STRESS(ES) ASSOCITED WITH DEVICE USAGE OVER TIME.
A 8 FR CATHETER INSERTED ON ?. ON 8/14/96, A CHEST X-RAY REVEALED THAT A PORTION OF THE CATHETER WAS NOTED TO BE IN THE PT'S RIGHT ATRIUM AND SUPERIOR VENA CAVA. THIS WAS REMOVED PERCUTANEOUSLY BY AN INTERVENTIONAL RADIOLOGIST. THE PROXIMAL PORTION WAS REMOVED SURGICALLY.
THE CATHETER WAS RETURNED IN TWO FRAGMENTS. TACTUAL EXAMINATION OF THE CATHETER SHOWED WEAKNESS AT THE BREAK POINT. UNDER MAGNIFICATION, THE DISTAL TIP OF THE PROXIMAL FRAGMENT HAS GRANULAR WITH IRREGULAR EDGES. THE LUMEN OPENING WAS OVAL AND ONE SIDE OF THE LUMEN SHOWED SIGNS OF WEAR. THESE SIGNS ARE TYPICAL OF A CLAVICLE/FIRST RIB COMPRESSION FRACTURE, A COMPLICATION ASSOCIATED WITH THE MEDIAL PLACEMENT OF THE CATHETER IN THE SUBCLAVIAN VEIN.
DEVICE WAS INFUSED IN HEPATIC PT. PT WAS RECEIVING 20MG OF MITOMYCIN-C IN 250CC'S OF NORMAL SALINE THRU PORTA-CATH. EXTRAVASATION OCCURRED OF ALL OR A PART OF THE SOLUTION. RESULTED IN A SEVERE CHEMICAL BURN. LITIGATION IS PENDING. THE SURGEON WHO INSTALLED AND REMOVED THE DEVICE REPORTED NO APPARENT DEFECTS OR MALFUNCTION OF THE PORT. THE SURGEON'S OPINION IS OF NEEDLE MALFUNCTION OR MALPOSITION CAUSED EXTRAVASATION. NO A DEVICE FAILURE.
REPORTER STATED, NOT BELIEVED TO BE DUE TO PRODUCT ITSELF. FILED DUE TO FDA STATING ALL SYSTEMS EXPLANTED EXCEPT FOR END OF THERAPY ARE TO BE REPORTED AS SERIOUS INJURIES. THE PORTAL WAS RECEIVED WITH A 3 INCH LENGTH OF CATHETER ATTACHED. MICROSCOPY EXAMINATION OF THE PORTAL REVEALED A 0.5 INCH LONG VERTICAL SCRATCH ON THE SIDE OF THE PORTAL. THE ORIENTATION AND PHYSICAL CHARACTERISTIC OF THE SCRATCH IS CONSISTENT WITH THAT MADE BY A SHARP INSTRUMENT, SUCH AS A NEEDLE THAT MISSED THE SEPTUM DURING ATTEMPTED ACCESS. THE SEPTUM WAS ALSO NOTED TO BE DAMAGED IN ONE AREA AND A CORE OF SEPTUM MATERIAL PROTRUDED FROM THE SEPTUM. PRESSURIZATION OF THE SYSTEM, VIA NITROGEN, FOR ONE MIN PRODUCED NO LEAKAGE IN ANY AREA OF THE RETURNED COMPONENTS. THE OBSERVED DAMAGE TO THE SEPTUM IS CONSISTENT WITH IT HAVING BEEN ACCESSED VIA A NON HUBER STYLE NEEDLE.
TOTAL RIGHT KNEE ARTHROPLASTY REVISION FOR HARDWARE FAILURE.
AN ATTEMPT WAS MADE TO OBTAIN THE ACTUAL SAMPLE FOR ANALYSIS PURPOSES, BUT THE FACILITY STATED THAT THEY COULD NOT LOCATE THE SAMPLE.
THE ENTIRE DEVICE WAS RECEIVED AND EVALUATED BY THE MFR. A LEAKAGE SITE WAS DETECTED IN THE RESIPUMP. A MICROSCOPIC EXAMINATION OF THE LEAKAGE SITE WAS PERFORMED. THERE WAS A SEPARATION OF THE RESIPUMP MATERIAL AT THE JUNCTION BETWEEN THE SEPTUM AND THE PUMP BODY. THE CROSS SECTIONAL SURFACES OF THE SEPARATED MATERIAL SHOWED UNIFORM STRIATIONS, INDICATING CONTACT WITH SHARP INSTRUMENTATION, E.G. NEEDLE. BASED ON THE RECEIVED INFO AND QUALITY ASSURANCE'S EXAMINATION, QA CONCLUDES THAT THE RESIPUMP CONTACTED SHARP INSTRUMENTATION. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, QA CONCLUDES THAT THE OBSERVED DAMAGE OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED.
AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED.
IN AN UNSTABLE PT, DURING A PTCA OF A CHALLENGING RCA LESION, THE GUIDEWIRE BECAME STUCK WITHIN THE VESSEL. THIS OCURRED AFTER NUMEROUS ATTEMPTS WERE MADE TO CROSS THE LESION WITH THIS DEVICE AND OTHER BALLOON CATHETERS. FINALLY THE DECISION  WAS MADE TO DISCONTINUE THE PROCEDURE. UPON REMOVAL OF THE DEVICES IT WAS NOTED THAT THE GUIDE WIRE WAS STUCK INSIDE A SMALL BRANCH OF THE RCA WHERE IT HAD BEEN PLACED THROUGHTOUT THE ENTIRE PROCEDURE. THE GUIDE WIRE FRACTURED WHEN ATTEMPTS WERE MADE TO REMOVE IT. THE PT REMAINED STABLE THROUGHOUT THE PROCEDURE BUT DEVELOPED VENTRICULAR FIBRILLATION WHICH WAS SUCCESSFULLY CONVERTED TO NORMAL SINUS RHYTHM IN THE RECOVERY UNIT. THE PT REPORTEDLY HAD AN INFERIOR MYOCARDIAL INFARCTION DURING HOSPITALIZATION. AS OF THE DATE OF THIS REPORT THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION.
THIS EVENT WAS CALLED INTO THE DEVICE MFR. F10: PT CODES 2130. DEVICE CODES: 1638.
OTHER DEVICES USED. CATALOG #00-5780-070-04 TIBIAL TRAY LOT #61208300. CATALOG #UNKNOWN PATELLA DOME LOT # UNK. EVAL CODES FOR SECTIONH6: 86-100 DEVICE WAS NOT RETURNED. THEREFORE NO EVAL COULD BE MADE. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING NO. IF "Y" IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING. NA. IF "N" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING NO. IF "Y" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING ? NO. IF NO IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT IS UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNK OR IS NOT AVAILABLE. NO ADD'L INFO WIIL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE DEVICE WAS REMOVED DUE TO A "FLUID LOSS". THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED.
THE PUMP WAS RECEIVED AND EVALUATED BY THE MFR. TWO LEAKAGE SITES WERE DISCOVERED. ONE WAS LOCATED IN THE TUBING NEAR THE SERIALIZED STRAIN RELIEF JUNCTION. THE OTHER WAS NOTICED IN THE TUBING NEAR THE NON-SERIALIZED STRAIN RELIEF JUNCTION. THE LEAKAGE SITES WERE MICROSCOPICALLY EXAMINED. AT BOTH LEAKAGE SITES THE TUBING WAS SEPARATED. THE CROSS SECTIONAL SURFACES OF BOTH SITES SHOWED ROUGH IRREGULAR TUBING ENDS, INDICATING A TUBING TEAR. ABRASION WAS NOTED ON BOTH THE SERIALIZED AND NON-SERIALIZED TUBING. BASED ON THE INFO RECEIVED AND QUALITY ASSURANCE'S EXAMINATION, QA CONCLUDES THAT WHILE IN-VIVO THE SERIALIZED AND NON-SERIALIZED TUBING ABRADED AGAINST ONE ANOTHER. TUBING ABRASION SUGGESTS THAT POSITIONING OF THE DEVICE OR TUBING, WHILE IN-VIVO, MAY HAVE CONTRIBUTED STRESS(ES) TO THE DEVICE. THESE STRESS(ES) ALONG WITH THE STRESS(ES) ASSOCIATED WITH DEVICE USAGE OVER TIME CAUSED THE OBSERVED TUBING TEARS.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECCURRING INCONTINENCE - FLUID LOSS.
PUMP PERFORMED WITHIN SPEC. CUFF PERFORMED WITHIN SPECS. BALLOON PERFORMED WITHIN SPECS.
AFTER APPLYING A REUSABLE COLD COMPRESS TO HER BUTTOCKS, SHE SUFFERED 2ND AND 3RD DEGREE BURNS ACCORDING TO HER DOCTOR. SHE ALSO CLAIMS SHE HAS BEEN UNABLE TO WEAR CLOTHES FOR ELEVEN DAYS BECAUSE OF THIS EVENT.
THIS MEDICAL DEVICE REPORT IS SUBMITTED BY BECTON DICKINSON AND CO IN COMPLAINCE WITH21 CFR PART 803. THE SUBMISSION OF INFORMATION PURSUANT TO THIS RULE, OR PUBLIC RELEASE OF SUCH INFO BY FDA OR ANY OTHER PARTY DOES NOT CONSTITUTE AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A PRODUT AND A DEATH OR INJURY.
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION."
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PATIENT AND REPLACED DUE TO MALFUNCTION. ADDITIONAL INFORMATION RECEIVED ON 10/08/1996 INDICATES FLUID LOSS - RESERVOIR.
PUMP PERFORMED WITHIN SPECIFICATIONS. TUBING WAS FUNCTIONAL. RESERVOIR HAD A WEAR LEAK.
PT ALLEGES HAVING PROBLEMS, INCLUDING PAIN, THEY ARE HARD AS ROCKS AND HER VEINS STRICK OUT, HER BREASTS ARE SWOLLEN FROM THE IMPLANTS, SHE SUFFERS FROM BURNING AND PAIN IN JOINTS OF HANDS AND FINGERS. PT ALSO ALLEGES POSSIBLE HEPATIC/RENAL DYSFUNCTION FROM THE IMPLANTS. SHE ALSO STATES IMPLANTS NEED TO BE REMOVED.
PT ALLEGES HAVING PROBLEMS, INCLUDING PAIN, THEY ARE HARD AS ROCKS AND HER VEINS STICK OUT, HER BREASTS ARE SWOLLEN FROM THE IMPLANTS, SHE SUFFERS FROM BURNING AND PAIN IN JOINTS OF HANDS AND FINGERS. PT ALSO ALLEGES POSSIBLE HEPATIC/RENAL DYSFUNCTION FROM THE IMPLANTS. SHE ALSO STATES IMPLANTS NEED TO BE REMOVED.
THE DEVICE WAS REMOVED DUE TO "RESERVOIR EXTRUSION". A "HOLE IN THE TUBING NEAR THE CONNECTOR" WAS OBSERVED AT THE TIME OF SURGERY.
ACCORDING TO THE AVAILABLE INFORMATION, A PUMP, TWO CYLINDERS, AND A RESERVOIR WERE IMPLANTED ON 3/31/87. A REVISION OCCURRED ON 11/6/89 TO REPLACE THE PUMP. CONNECTORS WERE ALSO IMPLANTED AT THIS TIME. ON 9/11/96 THE CYLINDERS AND RESERVIOR IMPLANTED ON 3/31/87 AND THE PUMP IMPLANTED ON 11/6/96 WERE EXPLANTED. THIS FILE ADDRESSES THE 9/11/95 SURGERY, WHICH OCCURRED REPORTEDLY BECAUSE THE RESERVOIR MIGRATED. A HOLE IN THE CYLINDER TUBING WAS OBSERVED IN SURGERY. IN THE RECEIVED QUESTIONNAIRE, THE PHYSICIAN NOTED THAT AN INFECTION WAS NOT PRESENT. ADDITIONALLY, THE PATIENT ENCOUNTERED MIGRATED OF THE RESERVOIR THROUGH THE EXTERNAL RING TO THE RIGHT SCROTUM. THE PUMP, RESERVOIR, THREE CONNECTORS AND TWO CYLINDERS WERE RECEIVED AND EVALUATED BY THE MFR. TWO LEAKAGE SITES WERE DETECTED IN THE PUMP'S OUTLET TUBING. ONE EXISTED IN THE MICROSCOPIC EXAMINATION OF THE LEAKAGE SITES WAS PERFORMED. THE CROSS SECTIONAL SURFACES OF THE LEAKAGE SITES WERE SMOOTH AND SHOWED UNIFORM STRIATIONS, INDICATING CONTACT WITH SHARP INSTRUMENTATION, E.G. SCALPEL, SCISSORS. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCES EXAMINATION, QA CONCLUDES THAT THE TWO LEAKAGE SITES WERE CAUSED BY CONTACT WITH SHARP INSTURMENTATION. BASED ON THE DURATION THE DEVICE WAS IMPLANTED, QA FURTHER CONCLUDES THAT THESE SITES WERE MOST LIKELY CAUSED DURING OR SUBSEQUENT TO EXPLANT SURGERY, AND THEREFORE, ARE NOT RELATED TO THE CAUSE FOR SURGERY. SINCE QA'S EXAMINATION CAN NOT CONCLUSIVELY PROVE NOR DISPROVE THE REPORTED MIGRATION, QA ACCEPTS THE PHYSICIANS OBSERVATION OF MIGRATION AS THE CAUSE FOR INTERVENTION.
DURING A GASTRODUODENAL ANASTOMOSIS PROCEDURE, THE INSTRUMENT CUT AND DID NOT STAPLE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
11/21/96: SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE RETURNED TO MFR ON 10/24/96.
DURING PREHOSP TRANSPORT, IV ACCESS WAS ATTEMPTED IN THE FOREARM OF A FEMALE PT WHO HAD JUST PREVIOUSLY NEEDED ELECTRIC COUNTERSHOCK CONVERSION OF AN UNSPECIFIED DYSRHYTHMIA. THE CLINICIAN REPORTED AN INABILITY TO OBTAIN A FLASHBACK RESPONSE, WHICH WOULD NORMALLY INDICATE SUCCESSFUL ENTRY INTO THE VENOUS LUMEN. THE VEIN "ROLLED" DURING THE INSERTION ATTEMPT. WHEN THE DEVICE WAS REMOVED, A PORTION OF THE TUBING WAS NOTED TO BE MISSING. THE PT WAS TRANSPORTED TO THE EMERGENCY DEPT, WHERE THE SEVERED PORTION WAS RETRIEVED VIA A 1 CM VENOUS CUTDOWN. ONLY THE CATHETER ASSEMBLY WITH A PORTION OF REMAINING ATTACHED WAS RETURNED FOR ANALYSIS. THE RETRIEVED, SEVERED PORTION OF THE TUBING WAS DISCARDED AT THE FACILITY. THE PT WAS REPORTED TO BE "DOING WELL" FOLLOWING THE OCCURRENCE.
DATE SENT TO FDA: 9/27/96. CLARIFICATION FOR SECTION H6 EVALUATION CODE, METHOD: 86-OPTICAL EVALUATION OF THE POINT OF SEVERANCE. ADD'L CLARIFICATION OF INFO CONTAINED IN B7, D10 AND F12:  PT WHO IS IN A DYSRHYTHMIA WOULD NORMALLY NEED A COUNTERSHOCK CONVERSION ONLY IF IT HAS RENDERED PT HEMODYNAMICALLY UNSTABLE. SUCH A PT WILL BE MORE LIKELY TO POSE BOTH INSERTION AND ACCESS DIFFICULTIES TO A CLINICIAN ATTEMPTING IV ACCESS. ADDITIONALLY, INITIATING IV ACCESS MAY BE HAMPERED OR BE MADE LESS THAN IDEAL WHEN IT IS OCCURRING IN THE BACK OF A MOVING VEHICLE.
PT ALLEGES RECEIVING BREAST IMPLANTS ON AN UNKNOWN DATE AND OF AN UNKNOWN MFR. PT ALSO ALLEGES HAVING HEALTH PROBLEMS; HOWEVER, NO SPECIFICS WERE GIVEN.
9/25/96 - SUBMISSION OF INITIAL REPORT BY MFG. THE RISK MGR WILL BE RETAINING THE DEVICE AT THE HOSP.
ON 8/30/96, A MFR'S DIST REP CONTACTED THE MFR AND REPORTED THAT HE WAS PRESENT AT THE FACILITY WHEN MANAGER OF SURGICAL SERVICES PRESENTED HIM WITH THE DEVICE IN A STERILE RE-PACKAGE. THE FACILITY NURSE EXPLAINED THAT THE DEVICE WAS EXPLANTED BECAUSE THE PHYSICIAN COULD NOT FLUSH THE DEVICE AFTER IT WAS IMPLANTED. THE DIST REP REPORTED THAT WAS THE ONLY INFO WHICH WAS PROVIDED AT THAT TIME.
THE MFR RECEIVED THE DEVICE ON 9/11/96, FOR ANALYSIS AND THE RESULTS ARE AS FOLLOWS: VISUAL EXAM REVEALED A LARGE, DARK, AMBER COLORED PARTICLE UNDER THE DEVICE RESERVOIR. APPROX. TEN NEEDLE PENETRATION MARKS WERE SEEN CONCENTRATED IN THE CENTER OF THE DEVICE SEPTUM. THE TEN NEEDLE PENETRATION MARKS WERE SEEN EXTENDING INTO THE SILICONE MATERIAL OF THE DEVICE SEPTUM UNDER THE SURFACE, INTO THE LARGE, DARK, AMBER COLORED PARTICLE. THE DEVICE WAS PATENT UPON FLUSHING WITH NO RESISTANCE FELT AND APPROX. 5MLS OF CLEAR COLORLESS "PARTICLE FREE" FLUID WAS COLLECTED. A LEAK TEST CONFIRMED THAT THIS DEVICE DID NOT LEAK. THE LARGE, DARK, AMBER COLORED PARTICLE TESTED POSITIVE FOR BLOOD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND DID NOT REVEAL ANY TRENDS. BASED ON THE INFO AVAILABLE, THE CAUSE OF THE BLOOD FOUND IN THE DEVICE SEPTUM COULD NOT BE DETERMINED AND THE MD'S COMPLAINT OF "INABILITY TO FLUSH THE DEVICE AFTER IMPLANT", COULD NOT BE CONFIRMED. HOWEVER, IT IS POSSIBLE THAT THE LARGE BLOOD CLOT LOCATED IN THE CENTER OF THE DEVICE RESERVOIR MAY HAVE PARTIALLY AND/OR TOTALLY OCCLUDED THE DEVICE FLOW PATH. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING THE FILE ON THIS EVENT.
PT ALLEGES RECEIVING IMPLANTS ON AN UNKNOWN DATE AND FROM AN UNKNOWN MFR. PT HAS QUESTIONS AND ALLEGES PROBLEMS HAVE ARISEN; HOWEVER, NO SPECIFICS WERE GIVEN.
PT REFUSES ANY FURTHER COMMUNICATION WITH CO.
THE PT EXPERIENCED FLEXION CONTRACTURE AND LESS THAN 100 PERCENT OF FLEXION AND EXTENSION. THE BASEPLATE WAS ALSO REMOVED AT THIS TIME.
AS RECEIVED, THE TIBIAL BASEPLATE IS IN VERY GOOD CONDITION AND THE INSERT EXHIBITS INSIGNIFICANT WEAR. THE WEAR PATTERN IS ONLY SURFACE DEFORMATION DUE TO NORMAL COMPRESSION LOADING OF THE PLASTIC. THE INFO PROVIDED AND THE EXAMINATION RESULTS INDICATE THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH PT SOFT TISSUE.
PADS EXHIBITING DIFFICULTY IN INITIAL RELEASE OF LINER FROM ADHESIVE RING ATTRIBUTED TO AN INCOMPATIBILITY OF MATERIALS. CORRECTIVE ACTION IN PLACE.
DURING AN ANTERIOR RESECTION PROCEDURE. THE STAPLES DID NOT FORM PROPERLY. THE SURGEON COMPLETED THE PROCEDURE BY PERFORMING AN UNINTENDED COLOSTOMY. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY
9/27/96, MEDWATCH REPORT NOT RECEIVED BY MFR.
PT RECEIVED IMPLANTS ON AN UNKNOWN DATE. PT HAS RUPTURED IMPLANTS; HOWEVER, NO OTHER SPECIFICS GIVEN.
A PUMP WAS REMOVED FROM THE PT DUE TO RECCURRING INCONTINENCE AND REPLACED.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO EROSION AND REPLACED.
PT HAS SX'S SUGGESTIVE OF MILD INTERSTITIAL CYSTITIS, PERIPHERAL NEUROPATHY LT UE > RT UE, ANXIETY, DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, DEMENTIA, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, PAIN AND/OR BURNING SENSATION IN CHEST, INFLAMMATION OF CHEST /RIB CAGE, OCCASIONAL LOW GRADE FEVER, CHRONIC DIARRHEEA AND/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, CHRONIC DISCHARGE, FREQUENT MIGRAINES, SEVERE HEADACHES, CHEST PAINS W/NO FINDINGS, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS, INFLAMMATION, SWELLING, PAIN/ARTHALGIA, PERSISTANT JOINT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY UNDER ARMS LT > RT, LYMPH NODES REMOVED: LOCATION(S) ARM PIT, BX DONE, CHRONIC UNEXPLAINED MUSCLE SPASMS, MUSCLE PAIN AND BURNING, MUSCLE ATROPHY, FIBROMYLAGIA, UNEXPLAINED RASHES, SUN SENSITIVITY, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICANOMAS, CLUMSINESS/DROPS THINGS, MISJUDGES DISTANCE/RUNS INTO OBJECTS, SICCA (CLINICALLY), NIGHT SWEATS, CHOKING SENSATION, EASY BRUISING AND TINNITUS.
PT ALLEGES RECEIVING IMPLANTS ON 8/17/83. PT ALSO ALLEGES SHE NOTICED A LUMP IN HER BREAST IN 11/95. SHE STATES SHE IMMEDIATELY VISITED HER DR AND HE EXAMINED THE BREAST, AND NOTICED IRREGULARITIES. SHE ALLEGES, FOLLOWING A MAMMOGRAM; A TEAR WAS FOUND AND PHOTOGRAPHED, DISPLACEMENT OF GEL WAS IN THE ARM CAUSING NUMBNESS AND MUCH DISCOMFORT. ON 1/20/95 DR'S REPORT STATES PT'S IMPLANTS WERE REMOVED, AND LOOSE GEL WAS CLEANED FROM BREAST CAVITY. DR'S REPORT STATES PT HAD A COMPLETELY RUPTURED RIGHT IMPLANT AND AN INTACT LEFT IMPLANT. THERE WAS EVIDENCE OF SILICONE GRANULOMAS THROUGHOUT THE RIGHT CAPSULE. IN ADDITION, THE DR'S RECORD STATES AN ALMOST TOTAL CAPSULECTOMY (RIGHT SIDE) WAS THEN PERFORMED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION BECAUSE OF RADIATION.
THE PT EXPERIENCED PAIN AND LOSS OF RANGE OF MOTION. REVISION SURGERY REVEALED SUBSIDENCE OF THE TIBIAL BASEPLATE. THE TIBIAL INSERT WAS ALSO REMOVED AT THIS TIME.
SUMAMRY OF EVAL: THE TIBIAL BASEPLATE CANNOT BE EVALUATED FOR THE REPORTED SUBSIDENCE AS IT HAS NOT BEEN RETURNED TO CO. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN UNSUCCESSFUL. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS BASEPLATE FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE INFO PROVIDED SUGGESTS THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INADEQUATE CORTICAL SUPPORT. SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENT REPORT WILL BE SUBMITTED.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECCURRING INCONTINENCE - TISSUE ATROPHY.
THE VASCULAR GRAFT TWISTED DURING IMPLANTATION, SO HE EXPLANTED IT.
INVESTIGISTION INDICATED THAT PHYSICIAN MISINTERPRETEDF THE NORMAL SPIRAL EXTERIOR OF THE VEIN GRAFT AS TWISTING. CO EXPLAINED THIS TO THE DISTRIBUTER FOR RELAY TO THE MD. CO DETERMINEDF THAT THERE WAS NO PRODUCT MALFUNCTION.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 7/18/79. PT ALSO ALLEGES HARDNESS BEGINNING ON 5/13/83. SHE HAD AN OPEN CAPSULECTOMY ON HER LEFT SIDE ON 6/14/83. ON 8/16/96, DR STATES DENSE CAPSULAR CONTRACTURE AND PLANS REMOVAL OF BOTH IMPLANTS.
SECTION D-6: LOT NUMBERS HH038044 AND HH4196 PROVIDED IN REPORT; HOWEVER, CO CANNOT DETERMINE WHICH LOT NUMBER IS ASSOCIATED WITH WHICH DEVICE IMPLANTATION SIDE.
ON 10/7/82 AN AUS DEVICE WAS IMPLANTED. ON 12/9/82 THE CONTROL ASSEMBLY WAS REVISED. ON 1/20/87 THE CUFF AND PUMP WERE REVISED. ON 8/26/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECCURRING INCONTINENCE.
THE NURSE WAS POSITIONING THE LIGHT WHEN THE TUBE FELL OUT OF THE TROLLEY.
THE IMPROPER INSTALLATION AND LACK OF PREVENTATIVE MAINTENANCE OF THE DEVICE DIRECTLY CONTRIBUTED TO THE DEVICE FAILURE.
PT ALLEGES SHE RECEIVED IMPLANTS ON 7/2/90. SHE ALLEGES HARDENING AND SORENESS THAT STARTED ON 3/4/96, CONTINUING 3/11/96 AND 4/22/96. PHYSICIAN STATES PT DEVELOPED PERI PROSTHETIC ENCAPSULATION (BAKER III) ASSOCIATED WITH ULTRASONIC EVIDENCE OR RIGHT IMPLANT LEAK. BILATERAL REMOVAL SURGERY IS PLANNED.
UNABLE TO PERFORM ANALYSIS LEAD PARTIALLY RETURNED. LEAD RECEIVED IN A PARTIAL DISTAL 38CM PORTION WITH NO J STIFFENER WIRE DISCREPANCIES. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES LEAD WAS CUT OR SNIPPED 38CMS PROXIMAL OF ELECTRODE TIP, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS NO J STIFFENER WIRE DISCREPANCIES.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 5/17/88. PT ALLEGES EXPERIENCING PROBLEMS WITH HER IMPLANTS SINCE 8/92, INCLUDING; NUMEROUS CHEST INFECTIONS; PLEURISY AND STRESS. EARLY IN 1993, SHE ALLEGES EXPERIENCING LOCAL PAIN IN ARMPITS AND BREASTS. DR STATES PT WANTS SILICONE GEL PROSTHESIS REPLACED WITH SALINE PROSTHESES, DUE TO ONGOING HEALTH PROBLEMS AND PSYCHOLOGICAL SEQUELA.
PT ALLEGES SHE RECEIVED IMPLANTS ON 10/29/87. PT ALSO ALLEGES LEAKAGE ON 8/23/94. PHYSICIAN REPORTS LEAK AS REASON FOR PLANNED REMOVAL.
MFR RECEIVED A REPORT OF A PT WALKING INTO THE HAND CRANK ON A SIX YR OLD BED AND CUTTING HER LEG. THE ALLEGED INJURY REQUIRED 16 STITCHES.
PATIENT ALLEGES HER MAMMOGRAPHY REPORT SHOWED RUPTURE OF THE RIGHT BREAST IMPLANT. SURGEONS ARE ADVISING BILATERAL EXPLANTATION WHICH IS TO BE SCHEDULED.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED APPROX. 9MM PROXIMAL OF WELD SITE WITH NO PROTRUSIONS OBSERVED. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX. 79MM AND MIGRATED DOWN LEAD BODY APPRX. 11MM PROXIMAL OF WELD SITE WITH NO PROTRUSIONS OBSERVED. IT APPEARS THAT ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO APPROX. 88MM.
DEVICE ANALYSIS PROVIDED. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR. TECHNIQUE/TOOLS: INTRAVASCULAR COUNTER TRACTION, SHEATH(S). NO COMPLICATIONS.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO REMOVE FROM TISSUE. THE SURGEON RESECTED THE TISSUE AND APPLIED ANOTHER DEVICE. THE SECOND INSTRUMENT WAS ALSO DIFFICULT TO OPEN. THE INSTRUMENT WAS OPENED BY MANUAL MANIPULATION AND THE SURGEON APPLIED SUTURE TO REINFORCE THE APPLICATION SITE.
9/19/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
THE LEAD WAS EXPLANTED DUE TO J RETENTION WIRE FRACTURE WITHOUT PROTRUSION  THROUGH THE OUTER POLYURETHANE INSULATION.
CORNEAL BURN OCCURRED AT BEGINNING OF PHACO AND USED A STITCH TO CLOSE.
A CO SERVICE REP CHECKED THE SYSTEM AND FOUND THE CASSETTE TYPE SWITCHES WERE STUCK. THE FLUIDICS MODULE WAS REPLACED. THE HANDPIECE WAS NOT ISOLATED AND THE CONSUMABLES WERE NOT SAVED FOR EVAL. FAILURE IS NOT RELATED TO EVENT. THIS REPORT SUBMITTED TO FDA ON 9/25/96. THE MFR'S INTERNAL REFERENCE NUMBER IS 9-8889-96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC, PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE WIRE WOULD NOT ADVANCE PAST THE ADAPTER. THE DOCTOR TRIED (UNSUCCESSFULLY) TO USE FORCEPS TO PUSH THE WIRE FOR FILTER DEPLOYMENT. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH A COMPETITOR'S SYSTEM. NO FURTHER COMPLICATIONS WERE REPORTED.
THE WIRE WOULD NOT ADVANCE PAST THE ADAPTER. THE MD UNSUCCESSFULLY TRIED USING FORCEPS TO PUSH THE WIRE FOR FILTER DEPLOYMENT. PUSHER WIRE COULD BE ADVANCED PAST THE ADAPTER. THE HELMET CAP(BORST) WAS TIGHTENED TIGHTLY, BUT COULD BE LOOSENED. THE INSTRUCTIONS FOR USE STATE "TIGHTEN THE ADAPTER VALVE TO MINIMIZE REFLUX OF SALINE TOWARD THE FEEDER, BUT NOT SO TIGHT AS TO PREVENT THE PUSHER WIRE FROM ADVANCING FREELY." THE WIRE COULD BE ADVANCED PAST THE ADAPTER.
THIS EVENT WAS REPORTED AS "DYSFUNCTION". AND NO FURTHER INFO AVAILABLE.
PT TAKEN TO SURGERY 8/13/96 FOR REVISION OF V-P SHUNT. TAKEN BACK TO SURGERY 8/15/96 FOR REVISION OF V-P SHUNT DUE TO ALLEGED INSUFFICIENT FUNCTIONING OF CO'S VENTRICULAR CATHETER.
PRODUCT WAS NOT RETURNED TO MEDTRONIC PS MEDICAL. THE MFG RECORDS FOR THE PRODUCT WERE REVIEWED AND NO ANOMALIES WERE NOTED.
DEVICE EXPLANTED, REASON UNKNOWN. NO FURTHER INFORMATION PROVIDED.DEVICE EXP DATE: 3/1/00.
DEVICE EXPLANTED, REASON UNK. NO FURTHER INFORMATION PROVIDED.
USER WAS CLEANING EAR WITH SWAB WHEN COTTON TIP DISLODGED INSIDE EAR. REQUIRED MEDICAL ATTENTION TO REMOVE TIP TO PREVENT INFECTION.
ONCOLOGY PT WITH SARCOMA OF DISTAL FEMUR. UPON INSERTION OF TOOL DURING SURGERY, ALLEGEDLY THE TOOL BENT AND THE POINT WOULD NOT GO DOWN FAR ENOUGH. A MIDAS REX WAS USED TO REMOVE THE SHOULDER ON THE TOOL. THE FEMUR WAS CUT WITH BURR IN ORDER TO DISASSEMBLE.
USER FACILITY HAS ADVISED CO THAT THE DOCTOR AND THE HOSPITAL FEEL THIS EVENT IS NOT REPORTABLE. THEREFORE, THERE WILL BE NO MEDWATCH FORM FILED BY THE USER FACILITY.
ONCOLOGY PT WITH SARCOMA OF DISTAL FEMUR. DURING REVISION SURGERY, ALLEGEDLY THE TIBIAL HINGE BASE HAD POLY AND SILICON BUMBERS WHICH HAD DISASSOCIATED FROM THE TIBIAL BASE AND WERE ALLEGEDLY FREE FLOATING IN THE JOINT SPACE.
A LEGAL SUIT WAS RECEIVED WHICH ALLEGED THAT A PT WAS TREATED FROM 1981 THROUGH 1992 AND DEVELOPED "SERIOUS AND PERMANENT DAMAGE TO HEALTH, STRENGTH AND ACTIVITY AND SEVERE SHOCK TO HER NERVOUS SYSTEM." ADD'L INFO WAS NOT AVAILABLE.
ON 10/23/96, CLINICAL REPORT FORMS WERE RECEIVED FROM THE PHYSICIAN. THE PATIENT'S LAST TREATMENT WAS IN 1990 IN THE NASALABIAL FOLDS AND GLABELLA. NO SYMPTOMS OR SIGNS WERE REPORTED TO HIM BY THE PATIENT OR ANY ONE ELSE. HE HAD NOT SEEN THE PATIENT SINCE 1992, AT WHICH TIME SHE WAS IN GOOD HEALTH WITHOUT COMPLAINTS.
THE VALVE WAS IMPLANTED IN AN NPH PT (AFTER SAH), HAVING CAUSED OVERDRAINAGE AND RESULTANT SLV 3-4 DAYS AFTER IMPLANTATION. THE VALVE WAS PLACED AT THE LEVEL OF THE FORAMEN OF MONRO. REVISION WAS MADE USING ANOTHER 46822.
THE RETURNED PRODUCT WAS EVALUATED BY CO FOR PREIMPLANTATION PRESSURE, PRESSURE/FLOW CHARACTERISTICS, PATENCY AND SIPHONING. THE PRODUCT MET ALL CO'S PERFORMANCE SPECIFICATIONS. IT IS POSSIBLE THAT THE PERFORMANCE CHARACTERISTICS OF THIS VALVE WERE NOT APPROPRIATE FOR THE PT'S NEEDS.
A LAWSUIT WAS RECEIVED ALLEGING THAT APPROX 15 MOS AFTER THE IMPLANTATION OF A SPINAL SYSTEM THE SYSTEM REQUIRED REMOVAL.
CO IS SUBMITTING THIS REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT.
AFTER THE IAB HAD BEEN IN USE FOR SIX DAYS, THE PUMP GAVE HIGH PRESSURE HELIUM LEAK ALARMS. IT WAS NOTED THAT THE CATHETER CONTAINED SOME BLOOD AND WAS HUNG-UP IN THE FEMORAL ARTERY. THE IAB WAS REMOVED IN OR, AND THE ARTERY WAS REPAIRED. THERE WERE NO ADD'L PT COMPLICATIONS.
THE DEVICE WAS REPORTEDLY IMPLANTED ON 6/20/96. ON 7/4/96, THE PT WAS ALLOWED TO PARTIALLY BEAR WEIGHT ON THE AFFECTED LEG AND WAS DISCHARGED ON 7/7/96. AFTER DISCHARGE, THE PT BEGAN FULL WEIGHT BEARING AND SUFFERED ANOTHER FRACTURE DISTAL TO THE ORIGINAL FRACTURE SITE. THE DEVICE WAS EXPLANTED ON 7/17/96.
DEVICE HAS BEEN RETURNED AND IS SCHEDULED FOR EVALUATION.CO IS SUBMITTING THIS REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT.
THE TEE PROBE WAS CHECKED AFTER THE INCIDENT BY AN CO SALES REP. NO PROBLEMS WERE FOUND. MOST LIKELY, MEDICAL INTERVENTION WAS REQUIRED.
THE CUSTOMER REPORTED THAT DURING A TEE EXAM, THE SURFACE OF THE STOMACH WAS INJURED AND THERE WAS SOME BLEEDING.
A PHYSICIAN REPORTED A PT WHO WAS TREATED ON 9/3/96 IN THE NASOLABIAL FOLDS AND THE FINE LINES ABOVE THE UPPER LIP BORDER. A TOPICAL ANESTHETIC WAS USED PRIOR TO THE TREATMENT. ON 9/6/96 THE PT PRESENTED WITH 3 SMALL, INFLAMED BLISTERS ON THE RIGHT UPPER LIP TREATMENT SITE, EXACT DATE OF ONSET UNK, WHICH THE PHYSICIAN BELIEVED TO BE EITHER HERPES SIMPLEX OR LOCAL NECROSIS; KEFLEX AND ZOVIRAX WERE PRESCRIBED. ON 9/9/96, THE PT WAS SEEN; THE 3 BLISTERS HAD EACH FORMED CRUSTS (5-6MM DIAMETER). SHE WAS INSTRUCTED TO CONTINUE THE KEFLEX AND ZOVIRAX. ON 9/13/96, THE PT WAS SEEN AND THE SYMPTOMS HAD RESOLVED.
ON 4/7/97, FOLLOW-UP INFO WAS RECEIVED FROM THE PHYSICIAN. THE SYMPTOMS RESOLVED ON 9/13/96; SYMPTOMS RESOLVED OVER 7 DAYS ON ORAL KEFLEX AND ZOVIRAX OINTMENT.
THE DEVICE WAS ORIGINALLY IMPLANTED IN 3/93. THE DEVICE BROKE AND WAS REVISED IN 1995.
DEVICE HAS BEEN RETURNED AND EVALUATION IS SCHEDULED. CO IS SUBMITTING THIS REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT.
A TOTAL OF 5 IMPLANTS WERE PLACED ON 5/22/96. PT MAY BE DIABETIC. OTHER IMPLANTS MAY ALSO CAME OUT.
THE RETURNED IMPLANT WAS MEETS SPECS. THE PT'S PROBABLE DIABETIC CONDITION IS THE LIKELY CAUSE OF FAILURE.
THE TIBIAL INSERT BEARING COMPONENT BROKE.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCITONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUCTED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES.
RECEIVED MEDWATCH REPORT VIA FDA MEDICAL PRODUCTS REPORTING PROGRAM REPORT ID: 51963-1009797. THE REPORT INDICATED THAT INITIAL REPORTER HAD RECEIVED IMPLANTS AND BEEN DIAGNOSED WITH A VARIETY OF CONDITIONS AFTER IMPLANTATION. THESE CONDITIONS INCLUDE CHRONIC FATIQUE SYNDROME, MYOSITIS OR POLYMYOSITIS, HEADACHES, HEAT OR COLD SENSITIVE, ETC. THE DEVICES WERE EXPLANTED APPROX 8.5 YRS AFTER IMPLANTATION.
AS THE DEVICES WERE NOT RETURNED TO CO, NO PHYSICIAL EVALUATION WAS POSSIBLE, AND NO CONCLUSION COULD BE DRAWN. THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CUI CORPORATION THAT THE REPORT OR INFO THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. REPORTS ARE BASED ON INFO SUPPLIED TO CUI CORPORATION WITHOUT OUR INDEPENDENT AS TO ITS ACCURACY OR COMPLETENESS. IT IS UNDERSTOOD THAT THE INFO MAY NOT REPRESENT FACT AFTER INVESTIGATION. CO'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. FILING A MDR PURSUANT TO 21 CFR, PART 803.16 DOES NOT CONSTITUTE AN ADMISSION BY CORPORATION THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE NECESSARILY AN ACCURATE REFLECTION OF THE RESULTS AND CONCLUSIONS OF THE DEVICE EVALUATION. CO CONSIDERS THE INFO PROVIDED IN THIS REPORT TO BE HIGHLY CONFIDENTIAL, THEREFORE CO REQUESTS THAT YOU PROTECT IT FROM ANY FOIA REQUEST.
A TOTAL OF 5 IMPLANTS WERE PLACED 5/22/96. PT MAY BE DIABETIC. THE REMAINING IMPLANTS MAY ALSO CAME OUT.
THE RETURNED IMPLANT WAS EVALUATED AND MEETS SPECS. THE PT'S PROBABLE DIABETIC CONDITION IS THE LIKELY CAUSE OF FAILURE.
DURING A DIALYSIS FISTULA GRAFT PROCEDURE TWO BALLOON CATHETERS WERE INFLATED BEYOUND THEIR RECOMMENDED MAXIMUM PRESSURE AND RUPTURED. UPON REMOVAL THROUGH AN INTRODUCER SHEATH, SEGMENTS OF THE BALLOON MATERIAL DETACHED. THE BALLOON SEGMENTS WERE SURGICALLY RETRIEVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PT COMPLICATIONS. ATTEMPTS TO GAIN FURTHER DETAILS REGARDING THIS EVENT WERE UNSUCCESSFUL. BOTH BALLOON CATHETERS WERE DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITHOVERPRESSURIZATION OR USE IN A CALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AN USUALLY REQUIRE MUCH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURES. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. IT WAS ALSO INDICATED THAT BOTH BALLOON CATHETERS WERE INFLATED BEYOUND THEIR RECOMMENDED MAXIMUM PRESSURE. CO BELIEVES THESE FACTORS CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICES. HOWEVER, WITHOUT EVALUATING THE DEVICES, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "THE RATED BURST PRESSURE SHOULD NOT BE EXCEEDED. REFER TO PRODUCT LABEL FOR RATED BURST PRESSURES. INFLATION IN EXCESS OF RATED BURST PRESSURE SHOULD NOT BE EXCEEDED. REFER TO PRODUCT LABEL FOR RATED BURST PRESSURES. INFLATION IN EXCESS OF RATED BURST PRESSURE MAY CAUSE THE BALLOON TO RUPTURE. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATION, IMMEDIATELY  DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
THE HIP INITIALLY IMPLANTED IN 7/27/95, FRACTURED AND REQUIRED REVISION ON 8/19/96.
CO IS SUBMITTING THIS REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR THE EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFELCT A CONCLUSION BY FDA, CO, OR THE EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT.
THE CATHETER WAS EXPLANTED ON 8/27/96 DUE TO SUSPECTED LEAKAGE AROUND THE CATHETER. THE PT HAD NO INCIDENT RELATED MEDICAL SEQUELAE AND A REPLACEMENT CATHETER WAS IMPLANTED.
REQUEST FOR ADD'L INFO HAVE BEEN UNSUCCESSFUL. ENTIRE FORM COMPLETED BY MFR. BASELINE REPORT FOR THIS DEVICE FAMILY SUBMITTED WITH REPORT 2183502-1996-00001 DATED 8/27/96. H3. THE PORTAL WAS RECEIVED WITH A 7 INCH LENGTH OF CATHETER ATTACHED. THE PORTAL AND CATHETER WERE PRESSURIZED TO 45 PSIG  VIA NITROGEN FOR ONE MINUTE, NO DEFECTS OR ABNORMALITIES WERE OBSERVED.
A TOTAL OF 5 IMPLANTS PLACED 5/22/96. PT MAY BE A DIABETIC. THE REMAINING IMPLANTS MAY HAVE TO BE REMOVED.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. THE PT'S PROBABLE DIABETIC CONDITION IS THE LIKELY CAUSE OF FAILURE.
DURING PTCA OF A TORTUOUS LESION LOCATED IN THE PT'S LEFT CIRCUMFLEX, THE BALLOON REMAINED INFLATED FOR 90 SECONDS (REF. MFR RPT. #2024168-1996-00010). THE PT DID NOT EXPERIENCE ANY ST CHANGES DURING THIS TIME. THE BALLOON WAS SUCCESSFULLY DEFLATED AND WAS REMOVED FROM THE PT. THE PHYSICIAN OPTED FOR PLACING ANOTHER DILATATION CATHETER INSIDE THE PT FOR FURTHER INFLATION TO OPTIMIZE THE RESULT OF THE PTCA. AFTER FURTHER INFLATION WITH THE SECOND BALLOON CATHETER, A DISSECTION WAS NOTED. THE BALLOON DEFLATION TIME ON THE SECOND CATHETER WAS REPORTED TO BE 58 SECONDS. THE DEVICE WAS REMOVED FROM THE PT AND THE DISSECTION WAS SUCCESSFULLY TACKED WITH ANOTHER BALLOON CATHETER. THE PT IS REPORTED AS FINE.
DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTIAN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSPITAL, DISTRIBUTOR, OR FIELD REPRESENTATIVE.
AREA REPRESENTATIVE RECEIVED A CATHETER WITH A NOTE STATING THE PHYSICIAN WOULD LIKE TO KNOW WHAT HAD HAPPENED TO IT. NO OTHER EXPLANTATION WAS PROVIDED. THE PRODUCT HAD BEEN IMPLANTED.
THE MD INDICATED THAT THE SYSTEM HAD FUNCTIONED UNTIL 08/21/96 WHEN FLUSHING WITH NO PROBLEM OCCURRED BUT BLOOD ASPIRATION WAS NOT POSSIBLE. UROKINASE WAS ADMINISTERED WITHOUT SUCCESS. A SUBSEQUENT CONTRAST STUDY SHOWED LEAKING OF THE DYE. THE PT BECAUSE SEPTIC, DEVELOPED ENDOCARDITIS AND EXPIRED. THE MD STATED THAT THE PT HAD A BAD HEART, BUT FELT THE INFECTION DEVELOPED FROM THE SYSTEM. THE STERILIZTION RECORDS FOR THE LOT NUMBER OF THE DEVICE WERE CHECKED AND FOUND TO MEET ALL REQUIREMENTS FOR A STERILE, NON-PYROGENIC LOT. NO OTHER FREPORTS OF INFECTION FOR THIS LOT NUMBER HAVE BEEN RECEIVED. THE DEVICE WAS CONFIRMED TO LEAK FROM A SLIT IN THE CATHETER WHERE THE CATHETER FITS OVER THE PORTAL OUTLET TUBE. THE ORIENTATION AND PHYSICAL CHARACTERISTIC OF THE SLIT IS CONSISTENT WITH A MECHANICAL FAILURE OF UNK CAUSE.
DR. REPORTED THAT A PT CAME IN WITH ABUTMENT FRACTURED. DR STATED MT IT SEEMED TO BE AN OVERLOADED CASE WHICH CAUSED THE FRACTURE. PT IS REPORTEDLY FINE.
METHOD (86) PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DOCTOR.
PREVIOUSLY REPORTED AS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. THE PHYSICIAN WAS UNABLE TO PASS A NEW LEAD THROUGH THE SVC DUE TO THE TRAUMA AFTER EXPLANT OF THE OLD LEAD. THEREFORE THE RIGHT 4TH INTERCOSTAL SPACE WAS OPENED AND MULTIPLE TRANS ATRIAL LEAD POSITIONED. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR. TECHNIQUE/TOOLS: SHEATH(S), LASER, COMPLICATIONS LISTED ABOVE.
THE PT WAS ADMITTED INTO THE EMERGENCY ROOM WITH AN ACUTE MI AND SEVERE ST ELEVATIONS. DIABETIC PT WAS VERY UNSTABLE. DIAGNOSTIC CATHETERIZATION WAS PERFORMED AND INDICATED THAT THE PT'S MID RIGHT CORONARY ARTERY WAS TOTALLY OCCLUDED. A BALLOON CATHETER WAS INSERTED OVER A GUIDEWIRE TO PREDILATE THE TOTAL OCCLUSION. ONCE THE BLOCKAGE WAS OPENED, A 2.5 CATHETER AND DEVICE WAS PUT DOWN THE VESSEL USING A KISSING BALLOON TECHNIQUE TO DILATE BOTH THE PDA AND THE PDL AT THE SAME TIME. PHYSICIAN ALSO NOTED A PROXIMAL LESION LOCATED IN THE RIGHT CORONARY ARTERY. THE 4.0 CATHETER WAS PLACED WITH A GUIDEWIRE TO DILATE THE PROXIMAL RCA LESIONS. A PINHOLE RUPTURE OF THE BALLOON OCCURRED AT 10 ATMS WITH DYE EXTRAVASATION. PHYSICIAN OPTED TO NOT REPAIR DISSECTION AT THIS TIME. PT WAS GOING TO BE BROUGHT BACK TO THE CARDIAC CATH LAB FOR STENT IMPLANTATION AT A LATER DATE DUE TO THROMBUS. FURTHER REPORTED INFO INDICATED THAT DURING THE COURSE OF THE PROCEDURE, NOT RELATED TO PTCA OR THE PINHOLE RUPTURE, THE PT WAS SHOCKED AND A BALLOON PUMP WAS UTILIZED. RECENT FOLLOW-UP FROM THE ACCOUNT INDICATES THE PT HAD BEEN STENTED AND IS REPORTED AS DOING FINE.
THE DEVICE WAS RECEIVED FOR EVALUATION ON 9/4/96. INVESTIGATION REVEALED A PINHOLE WAS NOTED IN THE MID BALLOON. BALLOON CREASING AND WRINKLING WAS NOTED. THERE WERE NO SCRATCHES OR MARKS ON THE BALLON MATERIAL. THE CREASING/WRINKLING MAY HAVE BEEN CAUSED BY MANIPULATION PRIOR TO OR DURING THE PROCEDURE WHICH COULD HAVE INCREASED THE PROPENSITY TO PINHOLE. REVIEW OF THE LHR FOR THIS LOT DID NOT REVEAL ANY NON-CONFORMITIES. A ROOT CAUSE CANNOT BE DETERMINED.
A PT HAD GOOD OCCULSION, IMPLANT INTEGRATED, EVERYTHING FINE UNTIL AUGUST, IMPLANT BECAME MOBILE, NO INFECTION, TOOTH SITE #30. PT SHOWED NO SYMPTOMS. DR. FINDS NO REASON FOR FAILURE, THERE WAS PLENTY OF BONE. PT SAME PT AS PRIOR MDR REPORT #M589905.
SEVERAL NURSES, AT LEAST FOUR, EXPERIENCED NEEDLE STICK INJURIES TO THE HANDS OR FINGERS, OVER A ONE MONTH PERIOD WHEN DEPOSITING SYRINGES INTO THE CLEAR #4838-C CONTAINER IN THE ALMOND CABINET. SYRINGES HAD A TENDENCY TO ACCUMULATE IN THE TORTOUS PATH LID OF THE CONTAINER, AND THEY COULD NOT SEE WHEN NEEDLES WERE PROTRUDING UPWARD. THE NURSES SUBSEQUENTLY INCURRED NEEDLESTICKS AS A RESULT OF NEEDLES JAMMED IN THE LID. THE TYPE(S) OF SYRINGES WHICH CAUSED THE NEEDLESTICKS WERE UNKNOWN, AS WAS THE FILL LEVEL OF THE CONTAINERS WERE EITHER IN PT ROOMS OR NURSING STATIONS. IT IS UNKNOWN WHAT TYPE, IF ANY, FIRST AID WAS GIVEN.
FROM INCIDENT INVESTIGATION WITH EMPLOYEE HEALTH NURSE IT WAS DETERMINED THAT NURSE ATTRIBUTED THE HEIGHT OF CONATINER MOUNTING TO THE CAUSE OF INJURY BECAUSE THEY WERE MOUNTED ABOVE EYE LEVEL OF SHORTER NURSES, WHO WERE THUS UNABLE TO VIEW THE INSIDE OF THE LID. ADDITIONALLY, SHE STATED THE WINDOW WAS NOT "CLEAR" ENOUGH FOR THE NURSES TO SEE IF THE CONTAINER WAS FULL OR NOT. THE HOSP HAS DISCONTINUED USE OF THE ALMOND CABINET AND CONVERTED TO THE HIDDEN BRACKET. THE BRACKETS HAVE BEEN INSTALLED AT A LOWER HEIGHT IN ORDER TO INCREASE THE VISIBILITY OF THE CONTENTS OF THE CONTAINER, NURSE STATED THAT THERE HAVE BEEN NO ADDITIONAL NEEDLESTICKS SINCE THE CONVERSION TO THE HIDDEN BRACKET. PLEASE NOTE THAT SECTION F WAS COMPLETED BY THE MFR.
A NURSE EXPERIENCED A NEEDLE STICK INJURY WHEN DEPOSITING A SYRING INTO THE CLEAR CONTAINER IN THE ALMOND CABINET. SYRINGES HAD A TENDENCY TO ACCUMULATE IN THE TORTUOUS PATH LID OF THE CONTAINER, AND THE NURSE COULD NOT SEE WHEN NEEDLES WERE PROTRUDING UPWARD. THE NURSE SUBSEQUENTLY INCURRED A NEEDLESTICK AS A RESULT OF NEEDLES JAMMED IN THE LID. THE TYPE OF SYRING, FILL LEVEL OF THE CONTAINER AT THE TIME OF THE INCIDENT AND LOCATION OF CONTAINER IS UNKNOWN. IT IS UNKNOWN WHAT TYPE IF ANY, FIRST AID WAS GIVEN.
A NURSE EXPERIENCED A NEEDLESTICK INJURY WHEN DEPOSITING A SYRINGE INTO THE CLEAR CONTAINER IN THE ALMOND CABINET. SYRINGES HAD A TENDENCY TO ACCUMULATE IN THE TORTUOUS PATH LID OF THE CONTAINER, AND THE NURSE COULD NOT SEE WHEN NEEDLES WERE PROTRUDING UPWARD. THE NURSE SUBSEQUENTLY INCURRED A NEEDLESTICK AS A RESULT OF NEEDLES JAMMED IN THE LID. THE TYOPE OF SYRINGE, FILL LEVEL OF THE CONTAINER AT THE TIME OF THE INCIDENT AND LOCATION OF CONTAINER IS UNK. IT IS UNKNOWN WHAT TYPE, IF ANY, FIRST AID WAS GIVEN.
A NURSE EXPERIENCED A NEEDLE STICK INJURY WHEN DEPOSITING A SYRINGE INTO THE CLEAR CONTAINER IN THE ALMOND CABINET. SYRINGES HAD A TENDENCY TO ACCUMULATE IN THE TORTUOUS PATH LID OF THE CONTAINER, AND THE NURSE COULD NOT SEE WHEN NEEDLES WERE PROTRUDING UPWARD. THE NURSE SUBSEQUENTLY INCURRED A NEEDLESTICK AS A RESULT OF NEEDLES JAMMED IN THE LID. THE TYPE OF SYRING, FILL LEVEL OF THE CONTAINER AT THE TIME OF THE INCIDENT AND LOCATION OF CONTAINER IS UNKNOWN. IT IS UNK WHAT TYPE, IF ANY, FIRST AID WAS GIVEN.
A NURSE EXPERIENCED A NEEDLE STICK INJURY WHEN DEPOSISITING A SYRINGE INTO THE CLEAR CONTAINER IN THE ALMOND CABINET. SYRINGES HAD A TENDENCY TO ACCUMULATE IN THE TORTUOUS PATH LID OF THE CONTAINER, AND THE NURSE COULD NOT SEE WHEN NEEDLES WERE PROTRUDING UPWARD. THE NURSE SUBSEQUENTLY INCURRED A NEEDLESTICK AS A RESULT OF NEEDLES JAMMED IN THE LID. THE TYPE OF SYRINGE, FILL LEVEL OF THE CONTAINER AT THE TIME OF THE INCIDENT AND LOCATION OF CONTAINER IS UNKNOWN. IT IS UNKNOWN WHAT TYPE IF ANY FIRST AID WAS GIVEN.
THIS EVENT WAS REPORTED AS FIBROSIS. NO FURTHER INFO AVAILABLE.
PT SUSTAINED BURN TO LOWER LIP FOLLOWING LASER ABLATION OF LARYNGEAL PAPILLOMA. FIBER BURNED INSIDE BRONCOSCOPE. OXYGEN CONCENTRATION WAS 100%. THIS ACCOUNT RE-USES FIBERS. THEIR RE-USED FIBERS ARE GAS STERILIZED. CUSTOMER STATED THAT HE DID USE A STERILIZED RE-USED FIBER.
ALTHOUGH BOTH OXYGEN CONCENTRATION OF 100% AND RE-USE OF FIBERS IS CONTRAINDICATED IN THE PRODUCT LABELING THIS CUSTOMER IS DOING BOTH. EVALUATION OF THE FIBER INDICATED BURNING AT THE DISTAL END. HOWEVER, THE FIBER CLEAVED AND STRIPPED WITHOUT DIFFICULTY. IN ADDITION. THE FIBER PASSED SPOT-SIZE AND TRANSMISSION FUNCTIONAL TESTS.
REPORT RECEIVED OF SUSPECTED J-RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR'S OFFICE.
DURING A PTCA/STENT PROCEDURE, WHILE REMOVING THE GUIDEWIRE FROM THE PT, THE GUIDEWIRE TIP FRACTURED. THE PHYSICIAN ATTEMPTED TO RETRIEVE GUIDEWIRE FRAGMENT FOR 3 1/2 HRS IN CARDIAC CATH LAB BUT WAS UNSUCCESSFUL. THE PT WAS SENT TO BYPASS SURGERY AND FOR REMOVAL OF THE GUIDEWIRE FRAGMENT. THE PT IS REPORTED AS DOING FINE.
THE DEVICE WAS RECEIVED FOR EVALUATION ON 9/9/96. ANALYSIS INDICATED THAT 9.5CM OF THE DISTAL PORTION OF THE GUIDEWIRE WAS STRETCHED AND SEPARATED FROM THE BODY. THE GUIDEWIRE SEPARATED 15MM DISTAL TO THE PROXIMAL SOLDER JOINT. THE SHAPING RIBBON SHOWED EVIDENCE OF TORSIONAL LOADING THAT EXCEEDED THE STRENGTH OF THE DEVICE. THE FRACTURE FACE WAS MECHANICALLY DAMAGED WHICH OBSCURED THE FRACTURE MORPHOLOGY. BASED ON THE REPORTED INFO, THE EXACT CAUSE IF UNDETERMINED.
METHOD (86). PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DOCTOR.
CRACKED (NEONATE) STOPCOCK. BLOOD LOSS ESTIMATED AT 40-50CC. GIVEN TRANSFUSION AFTER 50% OF BLOOD VOLUME LOSS.
H6: 86=NO PRODUCT RETURNED FOR EVALUATION.
REPORT ALLEGES "THE BALLOON DOESN'T INFLATE EVENLY ON PRETEST." THE DEVICE WAS NOT USED ON THE PT.
CATHETER INSERTION ON 5/1/96. DEVICE WAS BELIEVED TO BE MALFUNCTIONING SO PT UNDERWENT SURGERY TO REMOVE DEVICE. DURING THE OPERATION, THE PORT WAS FOUND TO BE SEVERED FROM THE CATHETER. THE CATHETER HAD MIGRATED OUT OF SAFE RECOVERY BY THE SURGEON. THE PT WAS LATER TAKEN TO THE CARDIAC CATHERIZATION LAB FOR REMOVAL OF THE REMAINING PORTION OF THE CATHETER FROM THE PT.
DISTRIBUTOR REPORTED THE FAILURE OF AN ABUTMENT ABOUT 10 MONTHS AFTER INSERTION. NO OTHER INFO WAS GIVEN. NO PT INFO WAS GIVEN.
METHOD (86). PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DISTRIBUTOR.
DURING A PTCA PROCEDURE, THE GUIDING CATHETER KINKED. AS THE GUIDING CATHETER WAS BEING REMOVED, IT MOVED TO THE LEFT MAIN CORONARY ARTERY AND A DISSECTION OCCURRED. ANOTHER MFR'S BALLOON CATHETER WAS USED TO REPAIR THE DISSECTION. THE PHYSICIAN DETERMINED THAT SURGERY WOULD NOT BE PERFORMED. PT STATUS IS LISTED AS "OK."
RETURNED PRODUCT ANALYSIS REVEALED SEVERAL KINKS IN THE SHAFT. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED. NO MATERIAL OR MFG DEFICIENCIES WERE NOTED.
THE CLINICIAN SUSTAINED A NEEDLE STICK AFTER INSERTING THE DEVICE. THE CLINICIAN HAD PLACED THE USED DEVICE ON A TABLE, AND, WHEN SHE PICKED IT UP, HER THUMB SUSTAINED A NEEDLESTICK. THE USER REPORTED THAT SHE THOUGHT THE DEVICE WAS LOCKED. THE DEVICE WAS DISCARDED. THE USER WAS TREATED WITH THE ADMINISTRATION OR FIRST AID AND A TETANUS BOOSTER.
DATE SENT TO FDA: 9/27/96. CLARIFICATION FOR SECTION H6: EVAL CODE, CONCLUSIONS: CODE #74-REFERS TO MANUFACTURING RETAIN PRODUCT TESTED FROM THE SAME LOT NUMBER. ADD'L INFO FOR SECTION F10: CODE #2462-LABELED. SUMMARY OF COMPLAINT INVESTIGATION: BECAUSE THE ACTUAL DEVICE WAS DISCARDED, THE FACILITY PROVIDED THE LOT NUMBER OF OTHER DEVICES CURRENTLY IN USE AT THE FACILITY TO ALLOW FOR ANALYSIS OF MANUFACTURING RETAIN SAMPLES. IT IS UNCLEAR IF THE REPORTED LOT NUMBER REPRESENTS THE SAME LOT NUMBER OF THE DEVICE INVOLVED IN THE NEEDLESTICK. SAMPLES FROM THE REPORTED LOT WERE TESTED FOR FUNCTION OF THE SAFETY MECHANISM. RESULTS OF THIS TESTING SHOWED THAT ALL RETAIN SAMPLES WERE WITHIN SPECIFICATION. NO NONCONFORMANCES WERE NOTED ON THESE SAMPLES. ADDITIONALLY, A COMPLAINT HISTORY REVIEW FOR THE TIME PERIOD OF 01/01/95 THROUGH 9/18/96 SHOWED THAT NO COMPLAINTS FOR EITHER NEEDLESTICKS OR SAFETY MECHANISM MALFUNCTIONS WERE REPORTED FOR THIS PRODUCT. CO IS UNABLE TO CONFIRM ANY MANUFACTURING RELATED CAUSE FOR THE OCCURRENCE OF THIS NEEDLESTICK. THE CUSTOMER WILL BE ADVISED OF CO'S FINDINGS. THE FACILITY HAS BEEN OFFERED ADD'L TRAINING ON THE PROPER USE OF THE DEVICE IN RESPONSE TO THIS REPORT.
ONE 8.75 INCH LENGTH OF CATHETER WAS RETURNED. NO OTHER COMPONENTS WERE RECEIVED. MICROSCOPY EXAMINATION OF THE PROXIMAL END OF THE CATHETER REVEALED THAT THE SURFACE WAS ROUGH AND JAGGED. WITHOUT EVALUATING THE SYSTEM COMPONENTS TO WHICH THIS LENGTH OF CATHETER WAS ATTACHED, CO'S PERSONNEL ARE UNABLE TO DETERMINE THE CAUSE OF THE OBSERVED BREAKAGE.
REPORT ALLEGES "PREMATURE BALLOON DEFLATION." RPTR ALLEGES THE DEVICE WAS USED IN OR ON A PT, HOWEVER, PT WAS NOT INJURED BY THE DEVICE. L/N PROVIDED IS INCONSISTENT WITH CO NUMBERING SYSTEM.
D6, L/N PROVIDED IS INCONSISTENT WITH CO NUMBERING SYSTEM.
AN IMPLANT, WHICH WAS PLACED INTO AN IMMEDIATE EXTRACTION SITE FAILED TO INTEGRATE. PT IS REPORTEDLY FINE.
SEVEN NEEDLESTICK INCIDENTS, INCLUDING SIX HOSP PERSONNEL AND ONE VISITOR WERE REPORTED TO BE ASSOCIATED WITH NEEDLES GETTING CAUGHT IN THE TORTOUS PATH OF #4838-C SHARPS CONTAINERS IN ALMOND CABINETS. THE CONTAINERS WERE LESS THAN 1/2 FULL AND SYRINGES HAD NOT DROPPED THROUGH THE TORTOUS PATH LID AND WERE POINTING UPWARD. ALL PERSONNEL WERE GIVEN FIRST AID OF UNKNOWN TYPE FOR THEIR INJURIES. THE INCIDENT WERE REPORTED. ATTACHED ARE INDIVIDUAL REPORTS FOR EACH OF SEVEN NEEDLESTICK INCIDENTS.
AN INCIDENT INVESTIGATION WITH INFECTION CONTROL EMPLOYEE HEALTH NURSE, INDICATED THAT ALL CASES, THE CONTAINERS WERE LESS THAN 1/2 FULL AND SYRINGES HAD NOT DROPPED THROUGH, THE TORTOUS PATH LID AND WERE POINTING UPWARD, AS ORIGINALLY REPORTED, ONE VISITOR ALSO INCURRED A NEELE STICK INJURY. THE NURSES THINK CONTAINERS ARE TOO HIGH BECAUSE IT IS HARD FOR THEM TO SEE HOW FULL THEY ARE. ALSO, THE DESIGN DOES NOT PROVIDE FOR EASY DROPPING OF THE NEEDLES. PLEASE NOTE THAT SECTION F WAS COMPLETED BY MFR.
A VISITOR EXPERIENCED A NEEDLESTICK INJURY ASSOCIATED WITH NEEDLES GETTING CAUGHT IN THE TORTOUS PATH OF #4838C SHARPS CONTAINER IN AN ALMOND CABINET.THE CONTAINER WAS LESS THAN 1/2 FULL AND SYRINGES HAD NOT DROPPED THROUGH THE TORTUOUS PATH LID AND WERE STICKING UPWARD. IT IS NOT KNOWN WHETHER THE VISITOR RECEIVED ANY FIRST AID OR TESTING.
A HOSP EMPLOYEE EXPERIENCED A NEEDLE STICK INJURY ASSOCIATED WITH NEEDLES GETTING CAUGHT IN THE TORTUOUS PATH OF #4838-C SHARPS CONTAINER IN AN ALMOND CABINET. THE CONTAINER WAS LESS THAN 1/2 FULL AND SYRINGES HAD NOT DROPPED THROUGH THE TORTUOUS PATH LID AND WERE STICKING UPWARD. THE EMPLOYEE WAS GIVEN FIRST AID OF UNKNOWN TYPE FOR THIS INJURY. THE INCIDENT WAS REPORTED.
A HOSP EMPLOYEE EXPEREINCED A NEEDLE STICK INJURY ASSOCIATED WITH NEEDLES GETTING CAUGHT IN THE TORTUOUS PATH OF #4838-C SHARPS CONTAINER IN AN ALMOND CABINET. THE CONTAINER WAS LESS THAN 1/2 FULL AND SYRINGES HAD NOT DROPPED THROUGH THE TORTUOUS PATH LID AND WERE STICKING UPWARD. THE EMPLOYEE WAS GIVEN FIRST AID OF UNKNWON TYPE FOR THIS INJURY. THE INCIDENT WAS REPORTED.
A HOSP EMPLOYEE EXPERIENCED A NEEDLE STICK INJURY ASSOCIATED WITH NEEDLES GETTING CAUGHT IN THE TORTUOUS PATH #4838-C SHARPS CONTAINER IN AN ALMOND CABINET. THE CONTAINER WAS LESS THAN 1/2 FULL AND SYRINGES PATH LID AND WERE STICKING UPWARD. THE EOMPLOYEE WAS GIVEN FIRST AID OF UNKNOWN TYPE FOR THIS INJURY. THE INCIDENT WAS REPORTED.
A HOSPITAL EMPLOYEE EXPERIENCED A NEEDLE STICK INJURY ASSOCIATED WITH NEEDLES GETTING CAUGHT IN THE TORTUOUS PATH OF #4838-C SHARPS CONTAINER IN AN ALMOND CABINET. THE CONTAINER WAS LESS THAN 1/2 FULL AND SYRINGES HAD NOT DROPPED THROUGH THE TORTUOUS PATH LID AND WERE STICKING UPWARD. THE EMPLOYEE WAS GIVEN FIRST AID OF UNKNOWN TYPE FOR THIS INJURY. THE INCIDENT WAS REPORTED.
A HOSPITAL EMPLOYEE EXPEREIENCED A NEEDLE STICK INJURY ASSOCIATED WITH NEEDLES GETTING CAUGHT IN THE TORTUOUS PATH OF #4838-C SHARPS CONTAINER IN AN ALMOND CABINET. THE CONTAINER WAS LESS THAN 1/2 FULL AND SYRINGES HAD NOT DROPPED THROUGH THE TORTOUS PATH LID AND WERE STICKING UPWARD. THE EMPLOYEE WAS GIVEN FIRST AID OF UNKNOWN TYPE FOR THIS INJURY. THE INCIDENT WAS REPORTED.
CUFF WAS FOUND TIGHT BUT DEFLATED AROUND PT'S ARM AT THE END OF A 6 HR PROCEDURE. CUFF WAS NOT USED DURING THE PROCEDURE BUT WAS LEFT IN PLACE ON PT'S ARM. AN IV WAS ALSO PRESENT ON THE SAME ARM.
DURING A PTCA PROCEDURE, THE BALLOON RUPTURED AND THE VESSEL CLOSED. ANOTHER BALLOON CATHETER WAS USED TO OPEN THE VESSEL. PT STATUS IS LISTED AS "OK."
RETURNED PRODUCT ANALYSIS REVEALED A SMALL TEAR IN THE BALLOON MATERIAL. THE CAUSE OF THE BALLOON TEAR COULD NOT BE DETERMINED. NO MATERIAL OR MFG DEFICIENCIES WERE NOTED.
AN INVASIVE PROCEDURE WAS PERFORMED TO REMOVE FROM SVC TWO LEADS DUE TO INAPPROPRIATE SHOCKS AND SPURIOUS TONES ON THE BEEP-O-GRAM. THE PHYSICIAN ELECTED TO REPLACE THE ICD AND THE TWO LEADS BECAUSE ONE OF THE LEADS WAS FRACTURED. CO IS UNABLE TO CONFIRM THE LEAD WITH THE FRACTURE, BOTH LEADS ARE LISTED ON THIS REPORT. IMPLANTED 8/3/96. OUT OF SVC 6/21/96. IMPLANT MONTHS 34.6.
510K #950928. 1 PERSON SERIOUS INJURY TYPE G. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IS SEVERITY OF THIS EVENT GREATER THAN LABELED? NO.
SURING AN EXAMINATION THE LIGHT DROPPED OUT OF THE DRIP TUBE. THE LIGHT HIT THE PT AND THE PT REQUIRED STITCHES.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON LOW IMPEDANCE, OVERSENSING, OR INAPPROPRIATE SHOCKS. NO FURTHER INFO IS AVAILABLE.
THE USER FACILITY REPORTED THAT A SURGICAL PT, ASSESSED AS HAVING POOR VASCULAR ACCESS, HAD A 14 GAUGE IV CATHETER DEVICE PLACED INTO THE EXTERNAL JUGULAR VEIN BY AN ANESTHESIOLOGIST. THE DEVICE WAS ALLOWED TO DWELL BEYOND THE NORMAL 72 HR LIMIT SET BY THE FACILITY DUE TO THE VASCULAR ASSESSMENT. WHEN THE DEVICE WAS REMOVED, IT WAS DISCOVERED TO BE SEVERED. A SURGEON RETRIEVED THE SEVERED PORTION OF THE CATHETER FROM THE PT VIA A SMALL INCISION WHICH WAS PERFORMED AT THE BEDSIDE. THE DEVICE WAS DISCARDED AT THE FACILITY, AND NO LOT NUMBER WAS AVAILABLE. THE PT IS REPORTED TO HAVE SUFFERED NO ADVERSE OUTCOMES FROM THE OCCURRENCE.
DATE SENT TO FDA: 9/27/96. F10: CODE #2357-NOT LABELED. CODE #1830-LABELED. INVESTIGATION SUMMARY: THE CLINICIAN WHO DISCONTINUED THE CATHETER STATED THAT, AFTER SHE HAD REMOVED THE TRANSPARENT SEMIPERMIABLE MEMBRANE DRESSING FROM THE SITE, SHE NOTED THAT ONLY A SMALL PORTION OF JAGGED TUBING REMAINED ATTACHED TO THE HUB OF THE DEVICE. SHE ALSO STATED THAT THE DEVICE HAD BEEN CONNECTED TO AN UNKNOWN BRAND OF INTERMITTENT INJECTION CAP AT THE TIME THAT THE CATHETER WAS DISCONTINUED. IT HAS BEEN CO'S EXPERIENCE THAT WHEN A PORTION OF THE TUBING REMAINS ATTACHED TO THE HUB AND IS JAGGED IN APPEARANCE, THE TUBING WILL HAVE BEEN SUBJECTED TO NUMEROUS PERFORATIONS FROM A SHARP TAPERED OBJECT SUCH AS AN IV INJECTION NEEDLE. PREVIOUS INVESTIGATIONS HAVE SHOWN THAT, WHEN TENSION IS APPLIED TO TUBING WHICH HAS BEEN PUNCTURED IN THIS WAY, THE TUBING WILL SEVER. THE POSSIBILITY OF SUCH DAMAGE APPEARS TO HAVE BEEN INCREASED BY THE EXTENDED DWELL TIME AND THE CHOSEN SITE, WHICH CAN BE A POINT OF FLEXION IN SOME PTS. THE USE OF AN INTERMITTENT INJECTION CAP WOULD ALSO HAVE CONTRIBUTED TO THE DAMAGE OF THE TUBING IF THE CAP WAS TOO SHORT TO ACCOMMODATE A ONE INCH NEEDLE OR IF INJECTION NEEDLES USED TO ACCESS THE CAP WERE LONGER THAN ON INCH. CO CONCLUDED, FROM THE INFO AVAILABLE, THAT THE SEVERANCE WAS MOST LIKELY CAUSED BY THE APPLICATION OF IMPROPER PROCEDURES IN CONJUNCTION WITH CLINICAL CIRCUMSTANCES. ANY IV CATHETER WILL SEVER WHEN IMPROPER PROCEDURES ARE EMPLOYED DURING USE. CO'S INSTRUCTIONS, WHICH ARE INCLUDED WITH THE PRODUCT PACKAGING, ADVISE THE USER TO USE AN INJECTION CAP WHICH IS LONG ENOUGH TO ACCOMMODATE A ONE INCH INJECTION NEEDLE AND TO AVOID THE USE OF ANY INJECTION NEEDLE WHICH IS LONGER THAN ONE INCH. CORRECTIVE ACTION FOR THIS COMPLAINT ENTAILS ADVISING CO'S CUSTOMER OF CO'S FINDINGS AND REVIEWING PROPER INSERTION AND MAINTENANCE PROCEDURES WITH THE CUSTOMER.
510K #935276. 1 PERSON. SERIOUS INJURY. TYPE G. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IS SEVERITY GREATER THAN LABELED? NO.
INFECTED GRAFT. DEVICE EXPIRATION DATE: 8/2/2000.
FOUR NEEDLESTICK INJURIES TO THE HANDS OR FINGERS WERE EXPERIENCED BY HOSP EMPLOYEES. IN ALL SITUATIONS THE NEEDLESTICKS HAD OCCURRED AS A RESULT OF THE SYRINGES NOT DROPPING COMPLETELY TO THE BOTTOM OF THE 4838-C SHARPS CONTAINER AND ACCUMULATING IN THE TORTOUS PATH LID OF THE UNIT. THE SHARPS CONTAINERS WERE IN A CLOSED ALMOND CABINET AT THE TIME OF THE INCIDENTS. SOURCE WAS UNSURE OF THE TYPE OR SIZES OF NEEDLES THAT CAUSED THE STICKS, BUT STATED THAT THE STICKS HAD RESULTED FROM "I.V. BUTTERFLIES" OR SYRINGES ACCUMULATING IN THE LID, AND THE NURSES NOT SEEING THEM WHEN THEY WENT TO DISPOSE OF THE NEXT SYRINGE. SHE STATED THAT IN TWO INCIDENTS THE CONTAINERS DID APPEAR TO BE OVERFILLED, BUT IN THE OTHER TWO, THE SYRINGES HAD JAMMED IN THE LID AND THE CONTAINER WAS APPROX HALF FULL. FIRST AID WAS GIVEN FOR THE WOUNDS.
INVESTIGATION INDICATED SYRINGES ARE DROPPING ALL THE WAY TO THE BOTTOM AND ARE GETTING STUCK IN THE MIDDLE OF THE CONTAINER. PLEASE NOTE THAT SECTION F HAS BEEN COMPLETED BY THE MFR.
A NURSE EXPEREINCED A NEEDLESTICK INJURY TO THE HAND OR FINGER WHILE DISPOSING A SYRINGE IN A SHARPS CONATINER HOUSED IN AN ALMOND CABINET.
A NURSE EXPERIENCED A NEEDLESTICK INJURY TO THE HAND OR FINGER WHILE DISPOSING A SYRINGE IN A SHARPS CONTAINER HOUSED IN AN ALMOND CABINET.
CLEAR I.V. PORT SEPARATED FROM FEMORAL SHEATH. THE PT LOST TWO UNITS OF BLOOD.
VISUAL EXAMINATION: UPON RECEIPT, IT WAS NOTED THAT THE CLEAR SIDEPORT TUBING WAS DISCONNECTED FROM THE CSI AT THE BARB. DRIED BLOOD STAINS WERE ALSO NOTED ON THE TUBING. A COMPRESSION RING CREATED BY THE TUBING BEING PLACED OVER THE CSI BARB WAS OBSERVED ON THE END OF THE SIDEPORT TUBING. THIS RING INDICATES THAT THE END OF THE TUBING WAS PLACED A DISTANCE OF 1MM OVER THE BARB, BUT DID NOT COMPLETELY COVER THE BARB. THIS CONDITION HAS BEEN ATTRIBUTED TO AN ISOLATED MFG INSPECTION ERROR. A REVIEW OF THIS PRODUCT'S HISTORY FOR THE LAST THREE YEARS REVEALED THAT SIDEPORT TUBING DISCONNECTING HAS OCCURRED AT A RATE OF .000275 PERCENT (2.75 PARTS PER MILLION).
THE IAB DEVELOPED A PINHOLE AND BLOOD WAS SEEN COMING BACK INTO THE CATHETER. THE IAB CATHETER WAS REPLACED WITHOUT INCIDENT TO THE PT.
THE DEVICE WAS INSERTED IN THE BICEP AREA. "THE PT DID NOT HAVE GOOD VEINS, IT WAS A HARD STICK". THE CATHETER WAS INSERTED IN A HOSPITAL THE DAY WHEN THE PT WAS BEING DISCHARGED TO THIS FACILITY'S CARE. WITHIN 72 HRS OF DWELL TIME THE ARM DEVELOPED REDNESS AND PAIN. WARMS SOAKS APPLIED WITHOUT RELIEF. PT ADMITTED TO THE HOSPITAL WHERE SHE WAS DIAGNOSED WIHT AN "INFECTION AND A BLOOD CLOT IN THE AREA WHERE THE CATHETER HAD BEEN REMOVED". A VEIN LIGATION WAS NECESSARY IN THAT AREA TO ALLEVIATE THE PROBLEM. THE PT WAS DISCHARGED HOME AFTER THE AREA HEALED.
DATE SENT TO FDA: 9/27/96. B4, F8, G4-MFR ALERT DATE INSERTED. CO HAS DECIDED TO DISCONTINUE MFR AND SALE OF THIS BRAND OF CATHETER, ANOTHER BRAND OF PERIPHERALLY INSERTED CATHETERS AND A MIDLINE CATHETER AS OF 9/18/96. ADD'L PT CODES: 1994-NOT ON LABEL; 2357-NOT ON LABEL. 2004-NOT ON LABEL; 2101-NOT ON LABEL; 1840-NOT ON LABEL.
THE VALVE WAS REMOVED APPROX 25 MONTHS POST IMPLANT DUE TO TRICUSPID INSUFFICIENCY. THE LEAFLET IN THE ANTERIOR POSITION WAS WORKING WELL, WHILE THE OTHER LEAFLETS WERE IN THE OPEN POSITION DUE TO THE PRESSURE NOT BEING GREAT ENOUGH TO CLOSE THE VALVE COMPLETELY. THE PT IS A 30 YR OLD FEMALE. THE VALVE WAS REPLACED WITH ANOTHER CO'S BIOLOGICAL VALVE.
SUBMISSION OF INFO BY CO UNDER THE MDR REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS NFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED.
TOTAL RT KNEE DONE 1994. LAST SEVERAL MONTHS HAD MARKED INCREASE IN PAIN, SWELLING AND RESTRICTION OF MOTION. ON 7/2/96 ARTHROSCOPY SHOWED FRACTURED POLY WITH A LOOSE PIECE OF THE POLY IN THE KNEE JOINT.
AN INVASIVE PROCEDURE WAS PERFORMED TO REMOVE FROM SVC TWO LEADS DUE TO "INAPPROPRIATE SHOCKS AND SPURIOUS TONES ON THE BEEP-O-GRAM." THE PHYSICIAN ELECTED TO REPLACE THE ICD AND THE TWO LEADS BECAUSE ONE OF THE LEADS WAS FRACTURED. CO IS UNABLE TO CONFIRM THE LEAD WITH THE FRACTURE, BOTH LEADS ARE LISTED ON THIS REPORT. IMPLANTED 8/3/96. OUT OF SVC 6/21/96. IMPLANT MONTHS 34.6.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 8/15/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 8/15/96.
MEDICAL INTERVENTION WAS REQUIRED TO REMOVE A CATHETER INSERTED ON 4/5/96. TWO IV TEAM NURSES ATTEMPTED TO REMOVE THE DEVICE WITHOUT SUCCESS. THE SECOND RN WAS "MORE AGGRESSIVE" IN ATTEMPTING TO DISCONTINUE THE CATHETER. HE WAS ABLE TO REMOVE 12 INCHES BEFORE MEETING RESISTANCE. THE PT WAS THEN SENT TO THE RADIOLOGY DEPT. FLUOROSCOPIC GUIDED REMOVAL WAS ATTEMPTED, DURING THE PROCEDURE" THE CATHETER BROKE AT THE HUB". THE PT BECAME DIAPHORETIC AND DEVELOPED TACHYCARDIA. A SECOND PROCEDURE, UNDER FLUOROSCOPIC GUIDANCE, THE DEVICE WAS RETRIEVED FROM THE PULMONARY ARTERY INTACT. THE PT WAS DIAGNOSED WITH PULMONARY EMBOLUS, TRANSFERRED FROM THE RADIOLOGY DEPT TO THE CORONARY CARE UNIT AND STARTED ON HEPARIN THERAPY. THE PT WAS LATER DISCHARGED HOME.
DATE SENT TO FDA: 11/15/96H6 - ADDITIONAL DATA CORRECTED DATA DEVICE CODE 1069 - LABELEDWITHOUT A LOT NUMBER OR SAMPLE, WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE INCIDENT REPORTED. WE WILL HOWEVER CONTINUE TO TRACK THIS TYPE OF INFORMATION, AS IT IS IMPORTANT TO OUR PRODUCT IMPROVEMENT AND DEVELOPMENT PROCESS.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO DELIVER A HEPARIN SOLUTION OF UNSPECIFIED CONCENTRATION AT 40 ML/HR. THE 500 ML CONTAINER WAS EXPECTED TO DELIVER OVER APPROX 12 HOURS. A NURSE NOTED THE IV CONTAINER WAS EMPTY AFTER 7 HOURS OF DELIVERY. THE INFUSION WAS DISCONTINUED AND THE PT RECEIVED PROTAMINE 25 MG IV DUE TO REPORTED PROLONGED LAB PTT VALUES. THE PT EXHIBITED NO SIGNS OF ANY ADVERSE EFFECTS AND NO ADVERSE SEQUELA HAVE BEEN REPORTED.
THE DEVICE IS EXPECTED TO RETURN FOR TESTING AND ANALYSIS BUT IT HAS NOT YET BEEN RECEIVED.
THIS EVENT WAS REPORTED AS "DYSFUNCTION." NO FUTHER INFO AVAILABLE.
AN ENGINEERING INVESTIGATION WAS INITIATED ON A SINGLE FIELD REPORT OF A FAILURE TO POWER UP WHEN ANOTHER MFR'S 1414 MODEM CARD IS INSTALLED IN THE REAR PCMCIA SLOT. THE MOST LIKELY TIME FOR THIS TO OCCUR IS DURING INITIAL DEVICE SETUP. PRIOR TO PT USE. HOWEVER, IN THE UNLIKELY EVENT THE MODEM IS INSTALLED AFTER THE DEVICE IS IN SVC AND LEFT INSTALLED, IT IS POSSIBLE THE FAILURE TO POWER UP COULD OCCUR DURING SUBSEQUENT USE. THE EVENT THAT TRIGGERED THE INVESTIGATION WAS NOT PT RELATED.
THE INVESTIGATION (PID#96-07-023) HAS DETERMINED THE ROOT CAUSE TO BE AN INTERNAL RE-DESIGN OF THE MODEM HARDWARE INTERFACE BY THE OTHER CO WHICH COULD RESULT IN A DEFIBRILLATOR LOCK UP. FOR PREVENTATIVE MAINTENANCE, A REPLACEMENT MODEM WILL BE PROVIDED TO CUSTOMERS. EXCEPT AS PROVIDED BY 21 CFR 803.24(E), CO DOES NOT INTEND TO PROVIDE ADD'L INFO ON THIS EVENT TO FDA.
AN 18 G DOUBLE LUMEN PICC WAS INSERTED 12 INCHES INTO A 27 YR OLD PT WITH SPINA BIFIDA. HIS EYES ROLLED BACK, HIS BODY STIFFENED AND HE PASSED OUT. HIS SAO2 DROPPED (THE AMOUNT WAS NOT AVAILABLE). HE WAS GIVEN OXYGEN BY 50% VENTIMASK, AFTER RECEIVING THE OXYGEN FOR A "COUPLE OF MINUTES" HIS SAO2 WAS 93%. HIS O2 SATURATION CONTINUED TO IMPROVE. THE PT AWAKENED. A DIFFERENT BRAND PICC WAS PLACED LATER THAT DAY WITHOUT DIFFICULTY, THE PHYSICIAN DIAGNOSED THE PT AS HAVING HAD A VASOVAGAL RESPONSE.
IN SPITE OF RESEARCH DONE TO DATE, CO HAS NOT BEEN ABLE TO ESTABLISH CAUSLITY FOR THIS TYPE OF EVENT.
THERE WAS NO REFLUX AVAILABLE. VACUUM GRABBED CAPSULE AND WOULD NOT RELEASE. THERE WAS NO CONFIRMED PT INJURY REPORTED.
NO CONSUMABLES WERE SAVED FOR EVALUATION. A CO SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND COULD NOT DUPLICATE REPORTED PROBLEM. PT INFO HAS BEEN REQUESTED FROM REPORTER, BUT HAS NOT BEEN RECEIVED TO DATE. THE MFR'S INTERNAL REFERENCE NUMBER IS 8-8805-96. THIS INFO IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN A CORONARY ARTERY. UPON THE INITIAL INFLATION ATTEMPT, ONLY THE DISTAL THIRD OF THE DELIVERY BALLOON INFLATED LEAVING THE STENT PARTIALLY EXPANDED AT THE TARGET LESION SITE. THE DELIVERY BALLOON WAS DEFLATED AND WITHDRAWN FROM THE PT WITHOUT COMPLICATION. TWO HIGH-PRESSURE BALLOON CATHETERS WERE SUBSEQUENTLY UTILIZED. THE FIRST BALLOON RUPTURED AND THE SECOND BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT AT THE TARGET LESION SITE. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
PT WAS IS SURGERY FOR AORTIC VALVE REPLACEMENT. SUTURES WERE PLACED IN THE ANNULUS OF THE PROSTHESIS. DR WAS USING A #23 VALVE SEATING PROVED TO BE TECHNICALLY DIFFICULT. WHIE USING A FREER ELEVATOR, IT SLIPPED AND TORE ONE OF THE LEAFLETS. BEGAN TO PREPARE ANOTHER PROSTHESIS. TIGHT FIT IN THE ANNULUS. APPARENT THAT THE AORTIC ROOT HAD TORN IN THE NONCORONARY CUSP AND THERE WAS A 5 TO 6 MM SEPARATION BETWEEN THE 2 EDGES OF THE AORTIC ROOT WHICH WERE BEING HELD APART BY THE NOW TAUT ANNULUS AROUND THE PROSTHESIS. PT ALSO HAD AN AORTOTOMY. ALSO HAD BLEEDING DIATHESIS.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCUDURE INVOLVING ONE PT. REPORTEDLY, THE SCOPE'S VISIBILITY WAS NOT CLEAR. THE HOSP REPORTED NO PT INJURY.
ROUTINE INVESTIGATION REVEALS A FALSELY HIGH RESULT COMPARED TO A LABORATORY COMPARISON. TREATMENT BASED ON HIGH RESULTS COULD HAVE CLINICALLY ADVERSE EFFECTS. NO INJURIES WERE REPORTED.
ONE CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY PLACED AT THE TARGET LESION SITE IN THE PT'S DISTAL RIGHT CORONARY ARTERY. A SECOND STENT WITH DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION SITE AND THE BALLOON RUPTURED ON THE DEPLOYMENT ATTEMPT. DURING AN ATTEMPT TO WITHDRAW THE STENT AND DELIVERY SYSTEM, THE STENT WAS WITHDRAWN TO THE MID RIGHT CORONARY ARTERY WHERE IT WAS FULLY DEPLOYED USING AN ADD'L BALLOON CATHETER. A THIRD STENT WAS SUCCESSFULLY PLACED BETWEEN THE TWO STENTS. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE RESULTS OF THE PRODUCT EVALUATION CONFIRM THE COMPLAINANT'S REPORT IN THAT A PINHOLE LEAK WAS IDENTIFIED IN THE PROXIMAL BODY OF THE DELIVERY BALLOON.
SUBMISSION OF INFO BY CO UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CASUAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED". ANALYSIS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE PROCESS DOCUMENTATION SHOWS THAT THE DEVICE MET SPECIFICATIONS AT THE TIME OF RELEASE. EVENT WAS INVESTIGATED AND ALTHOUGH THE VALVE WAS INVOLVED IN THE EVENT, THE CAUSE OF THE DAMAGE TO THE VALVE WAS DETERMINED TO HAVE BEEN CAUSED BY ANOTHER DEVICE DURING THE IMPLANT PROCEDURE. THE PT CODES LISTED ARE A RESULT OF THE DAMAGE THAT OCCURRED DURING THE PROCEDURE BY ANOTHER DEVICE AND NOT A RESULT OF THE PRODUCT FAILING TO MEET SPECIFICATION.
A 27 GAUGE SINAL NEEDLE TIP WAS SHEARED OFF DURING PLACEMENT OF SPINAL ANESTHESIA FOR CESAREAM SECTION. REQUIRED A LOCAL EXPLORATION FOR REMOVAL OF NEEDLE FRAGMENT. PT DID NOT SUFFER ANY IMPAIRMENT.
THE PT ON WHOM THE DEVICE WAS USED REPORTS SYMPTOMS OF PHLEBITIS WHICH OCCURRED WHILE THE DEVICE WAS IN USE ON THREE OCCASIONS. SYMPTOMS REPORTED ARE: ERYTHEMA, EDEMA AND PAIN AT THE SITE. THE PT WAS TREATED WITH ORAL ANTIMICROBIAL THERAPY AND WARM SOAKS, ON ONE OF THESE OCCASION, THE REPORTER STATED THAT THERE WERE NO OVERT SYMPTOMS OF INFECTION EITHER SYSTEMICALLY OR AT THE SITE. IV THERAPY AT THE TIME OF THE OCCURRENCES INCLUDED THE ADMINISTRATION OF IV ANALGESIA AND IV ANTIBIOTICS. A LIDOCAINE BLEB WAS INSTILLED AT THE INSERTION SITE PRIOR TO INSERTION OF THE DEVICES ON EACH OCCASION. THE REPORTER SUSPECTED THAT POWDER FROM THE EXAMINATION GLOVES MAY HAVE MIGRATED ONTO THE DEVICE AND MAY HAVE BEEN INTRODUCED INTO HIS CIRCULATORY SYSTEM, THEREBY CONTRIBUTING TO HIS SYMPTOMS OR CAUSING A LOCALIZED "PHYSICAL REACTION". THE REPORTER WAS UNSURE OF WHICH TYPE OF CATHETER WAS USED ON HIM.
DATE SENT TO FDA: 9/27/96. B3-DATE UNKNOWN, APPROXIMATE DATE IS 6 MONTHS PRIOR TO ALERT DATE. F-10: CODE #2004-NOT LABELED. INVESTIGATION SUMMARY: NO SAMPLES OR LOT NUMBERS WERE PROVIDED FOR THIS COMPLAINT, AND THE REPORTER WAS NOT SURE WHAT TYPE OF CATHETER HAD BEEN USED. FROM THE INFO PROVIDED, CO CONCLUDES THAT THE PT MOST LIKELY EXPERIENCED PHLEBITIS, A COMMONLY REPORTED COMPLICATION OF IV THERAPY. PHLEBITIS CAN BE CAUSED BY THE INFUSION OF CHEMICAL IRRITANTS, MECHANICAL IRRITATION OR POOR ASEPTIC TECHNIQUE. CLINICAL EVALUATION OF THE INFO CONCLUDES THAT EITHER THE IV ANALGESICS OR THE IV ANTIBIOTICS ADMINISTERED ON ALL THREE OCCASIONS MAY HAVE CAUSED A CHEMICAL PHLEBITIS IN THIS PT. ALTHOUGH THE PT REPORTED NO OVERT SYMPTOMS OF INFECTION, HE WAS TREATED WITH ORAL ANTIMICROBIALS ON ONE OF THESE OCCASIONS. ACCORDING TO INTRAVENOUS THERAPY, CLINICAL PRINCIPLES AND PRACTICE (INS, 1995), THE MOST COMMON CAUSE OF BACTERIAL PHLEBITIS IS POOR HAND WASHING AND POOR ASEPTIC TECHNIQUE. MECHANICAL PHLEBITIS IS USUALLY CAUSED BY LESS THAN OPTIMAL INSERTION TECHNIQUE OR INADEQUATE SECUREMENT OF THE DEVICE. ALTHOUGH THE INFO PROVIDED SUPPORTS THE CONCLUSION OF PHLEBITIS, IT IS POSSIBLE THAT THE INTRADERMAL ADMINISTRATION OF LIDOCAINE MAY HAVE CONTRIBUTED TO THE LOCALIZED MANIFESTATION OF SYMPTOMS. CO'S UNABLE TO CONFIRM ANY MANUFACTURING RELATED CAUSES FOR THE REPORTED SYMPTOMS. CORRECTIVE ACTION FOR THIS COMPLAINT ENTAILS ADVISING THE REPORTER OF CO'S FINDINGS AND EDUCATING HIM WITH REGARD TO THE MOST LIKELY CAUSES OF HIS SYMPTOMS.
ONE CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S RAMUS VEIN GRAFT. THE DELIVERY BALLOON WOULD NOT DEFLATE LEAVING THE STENT PARTIALLY EXPANDED AT THE TARGET LESION SITE. THE PARTIALLY INFLATED DELIVERY BALLOON WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION AND AN ADD'L BALLOON CATHETER WAS USED TO FULLY EXPLAND THE STENT. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN NATIVE CORONARY PROCEDURES ONLY. THE PRODUCT EVALUATION REVEALED THAT THE DIFFICULTY IN DEFLATING THE DELIVERY BALLOON WAS DUE TO THE OVER-TIGHTENING OF THE TUOHY-BORST VALVE.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS SEVERAL TEST RESULTS OUT-OF-RANGE WITH QUALITY CONTROL SOLUTION RANGES (INTENDED TO VERIFY DEVICE PERFORMANCE). HAD THESE RESULTS BEEN OBTAINED FROM A PT SAMPLE, COULD POTENTIALLY HAVE HAD AN ADVERSE EFFECT.
OUT-OF-RANGE RESULTS HAS BEEN HIGHLIGHTED IN THE USER MANUAL. 86 -TREND ANALYSIS FOR DEVICE LOT PERFORMED, NO ALERT LEVELS WERE EXCEEDED. 137-100 QUALITY CONTROL SOLUTIONS OUT OF RANGE, UNEXPECTED.
THE DEVICE WAS APPLIED AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SCOPE'S VISIBILITY WAS NOT CLEAR. THE HOSP REPORTED NO PT INJURY.
REPORT OF ALLEGED "UNIT DOES NOT CYCLE. ALARMS LOW POWER ON AC POWER. NO PT HARM." TESTING BY MFR FOUND A MOTOR STALL, WITH AUDIBLE LOW PRESSURE ALARM, DUE TO TRANSISTORS Q2 AND Q6 OR THE MOTOR BOARD BEING OUT OF SPEC. REPLACED Q2 AND Q6.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED. IF USED TO PERFORM AN ASSAY WITH TEST STRIPS FROM ANY REPORTED LOT, COULD RESULT IN HIGHER THAN EXPECTED RESULTS. NO INJURIES REPORTED IN THE FIELD.
IMPORTANCE OF CORRECT CALIBRATION OF THE DEVICE HIGHLIGHTED IN USER MANUAL.
THERE WAS AN ELECTRICAL SHORT OF THE LIGHT WHICH CAUSED SPARKING DURING HE USE OF THE LIGHT.
THIS PARTICULAR MODEL OF THE LIGHT INVOLVED IN THIS EVENT HAS NOT BEEN MFG IN OVER 7 YRS.
PT HAD RIGHT TOTAL HIP DONE 11/1/91. RECENTLY GETTING SOME ACHING SYMPTOMS IN THE HIP. (A START UP TYPE PAIN). GRADUALLY HAS BECOME WORSE. FOUND TO HAVE SOME LYSIS IN THE MID SHAFT OF THE LATERAL FEMUR AND LOOSENING AROUND THE ACETABULAR COMPONENT. PT ADMITTED TO HOSPITAL 8/22/96 FOR REVISION TOTAL HIP REPLACEMENT, (HAD COMPLICATIONS FEMUR FRACTURE). PRE OP DIAGNOSIS-ASEPTIC LOOSENING RIGHT TOTAL HIP REPLACEMENT WITH LYSIS OF FEMUR.
THE PT WAS IMPLANTED WITH PRODUCT LOT/SERIAL #DGS95I15-142. LOT DGS95I15 WAS MFR IN A CLASS 10,000 CLEANROOM. STERILITY TESTING WAS CONDUCTED IN A CLASS 100 HOOD. REVIEW OF CO'S RECORDS SHOW THAT: 1. BIOBURDEN VALUES DURING PRODUCTION WERE WITHIN SPECS. 2. ENVIRONMENTAL VIABLE AND NONVIABLE  PARTICULATE COUNTS WERE WITHIN SPECS. 3. THE LOT WAS MANUFACTURED ACCORDING TO ROUTINE, DOCUMENTED PROCEDURES AND PASSED ALL QUALITY CONTROL TESTS. 4. 100% OF THE 140 UNITS OF LOT DGS95I15 WERE TESTED FOR STERILITY. UNIT DGS95I15-142 WAS STERILE. ALL UNITS OF LOT DGS95I15 WERE STERILE. 5. AS OF SEPT 4 1996, CO RECEIVED BACK IMPLANT CARDS FOR 85 UNITS OF LOT DGS95I15. THIS IS THE ONLY COMPLAINT OF ANY KIND WE HAVE RECEIVED FOR THIS LOT. 6. PRIOR TO THIS INCIDENT AND THE EXPLANT RECORDED IN MEDWATCH 223302-96-0003 (FROM THE SAME HOSP AS HAS REPORTED ASPERGILLUS IS THIS MEDWATCH) CO HAS NOT SEEN REPORTS OF ASPERGILLUS ASSOCIATED WITH PRODUCT. 7. IN SECTION H6 OF THE MEDWATCH FORM, WE INDICATED METHOD CODES "11" AND "86" TO INDICATE THAT WE CONSIDER THE MOST APPROPRIATE EVAL IS OUR STERILITY RECORDS FOR THIS LOT  WHICH INDICATES THAT THE UNIT IN QUESTION (#142) PASSED STERILITY TESTING, AS DID ALL OTHER UNITS OF THIS LOT. IN SECTION H6 UNDER "RESULTS" CO INDICATES CODE "708", SINCE OUR RECORDS SHOW THE LOT TO HAVE MET SPECS FOR STERILITY. CO INDICATES CODE "331" (ENVIRONMENTAL FACTORS) UNDER "CONCLUSIONS" IN LIGHT OF THE TWO MEDWATCHS: 223302-1996-0003 AND 223302-1996-0007. IN BOTH CASES THE SAME HOSP HAS CULTURED THE SAME ORGANISM, EVEN THOUGH THE TWO INCIDENTS OCCURRED WITH TWO SEPARATE MANUFACTURING LOTS OF THE PRODUCT. BOTH UNITS WERE FOUND TO BE STERILE DURING ROUTINE MANUFACTURING TESTS. IN FACT, ALL UNITS OF BOTH LOTS SHOWED NO STERILITY FAILURES AS ASSESSED WITH A 100% STERILITY TESTING PROTOCOL. THEREFORE, CO SUSPECTS THE ASPERGILLUS ORGANISM IS OF NOSOCOMIAL ORIGINAL; THAT IS, THE INCIDENT OCCURRED DUE TO ENVIRONMENTAL FACTORS. CO INDICATES CODE "313" (INHERENT RISK OF PROCEDURE), SINCE SURGICAL INFECTION IS AN INHERENT RISK OF SURGERY.
THE BALLOON OF THIS DEVICE BURST UPON ITS FIRST INFLATION DURING AN ANGIOPLASTY PROCEDURE.
IAB ASSIS PT WITH GOOD AUGMENTATION FOR SEVEN HRS WHEN IAB WAS INSERTED FURTHER INTO PT. BLOOD WAS NOTED IN THE TUBING SEVERAL HRS LATER THE IAB WAS REMOVED AND REPLACED WITH ANOTHER. THE PT SUFFERED NO COMPLICATION.
ALL UNK INFO REQUESTED NOT REC. INTER# 061996080022.
THE DISPLAY WOULD INTERMITTENTLY BLANK. NO REPORTED PT INVOLVEMENT. SVC REP WAS ABLE TO DUPLICATE REPORTED CONDITION. DEVICE WAS REPAIRED AND PROPER OPERATION COFIRMED.
INVESTIGATION OF DEVICE WAS ABLE TO DUPLICATE DISPLAY CONDITION. SVC REP REPLACED LCD DISPLAY AND CONFIRMED PROPER OPERATION. AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE FURTHER INVESTIGATION IS REQUIRED AT THIS TIME, HOWEVER, CO WILL CONTINUE TO MONITER. SEE DISCLAIMER.
INTRAORTIC BALLOON (IABP) AFTER 6 (SIX ) DAYS SUDDENLY QUIT FUNCTIONING. IN REMOVING IT, IT WAS NOTED BALLOON WAS BLOOD FILLED AND IT HUNG UP IN THE FEMORAL ARTERY REQUIRING EMERGENCY TRIP TO OPERATING ROOM TO REMOVE BALLOON. PT'S ARTERY WAS REPAIRED AND HE TOLERATED SUDDEN CESSATION OF IABP. THE OPERATION REQUIRED BLOOD AND COMPONENT THERAPY TRANSFUSION. PT SUFFERED BALLOON PUMP MALFUNCTION THIS AM MANIFESTED BY MARKED DAMPENING OF WAVE FORMS. POSITION ON AM CHEST X-RAY WAS WITHIN NORMAL LIMITS. REPOSITIONING AFFORDED NO IMPROVEMENT. ATTEMPT AT REMOVING BALLOON IN UNIT (I.E., IN INTENSIVE CARE UNIT) REVEALED THAT BALLOON HAD RUPTURED AND THAT IT COULD NOT BE PULLED BACK THROUGH ILIACS SECONDARY TO INCOMPLTE CLOSURE FROM CLOT AND BLOOD IN BALLOON. PT TAKEN TO OR EMERGENTLY WHERE FEMORAL ARTERY EXPLORATION PERFORMED. BALLOON REMOVED AFTER FEMORAL ARTERIOTOMY PERFORMED. FEMORAL AND PROFUNDA ARTERY REPAIRED AND FLOW REESTABLISHED TO DISTAL LEFT LOWER EXTREMITY CONFIRMED BY DOPPLER SIGNAL AT DISTAL PROFUNDA AND AT POSTERIOR TIBIAL. PT TOLERATED BALLOON REMOVAL WITHOUT SIGNIFICANT HEMODYNAMIC COMPROMISE. APPROX 1200 CC BLOOD LOSS. RECEIVED 2 UNITS PACKED RED BLOOD CELLS- TYPE SPECIFIC- AND CRYSTALLOID. WILL NEED TO MONITOR FOR HEMODYNAMIC DETERIORATION. BALLOON HAS BEEN SECURED BY RISK MANAGEMENT OFFICE AND WILL BE TURNED OVER TO THE OFFICE OF THE MEDICAL CLAIMS JUDGE ADVOCATE.
DURING DAILY CHECK OF DEVICE, "PT NOT CONNECTED" MESSAGE WAS DISPLAYED. SVC REP DUPLICATED THE CONDITION, REPAIRED DEVICE, AND CONFIRMED PROPER OPERATION.
INVESTIGATION OF DEVICE WAS ABLE TO DUPLICATE "PT NOT CONNECTED MESSAGE". SVC REP REPLACED CABLE PRE-AMP ASSEMBLY AND CONFIRMED PROPER OPERATION. AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE FURTHER INVESTIGATION IS REQUIRED AT THIS TIME, HOWEVER, CO WILL CONTINUE TO MONITOR. SEE DISCLAIMER.
THERE ARE NO MARKINGS OF ANY KIND ON THESE SYRINGES.
THE SWITCH EMITTED SPARKS. CO'S INSPECTION REVEALED A BREAK IN THE OLD-STYLE LINE CORD. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS ADDED A CAUTION TO THE LABELLING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 12CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY IS ADDRESSED IN LABELING. FREQUENCY IS NOT OCCURRING GREATER THAN STATED IN LABELING. SEVERITY IS ADDRESSED IN LABELING. SEVERITY IS NOT GREATER THAN STATED IN LABELING.
PT WITH DX OR CHRONIC PELVIC PAIN AND DYSMENORRHEA HAD ELECTIVE OUTPT DIAGNOSTIC LAPAROSCOPY. UPON CLOSING THE FASCIA OF INCISION (2 CM ABOVE SYMPHYSIS PUBIS) WITH SUTURE, THE SUTURE NEEDLE BROKE OFF, WITH MORE THAN HALF OF THE NEEDLE LEFT IN THE PT'S ABDOMEN. (THE SURGEON RETRIEVED THE NEEDLE, GETTING STUCK BY THE NEEDLE WHILE DOING SO. HE WAS SEEN IN THE HOSPITAL'S EMERGENCY ROOM.) NO INJURY TO PT WHO WENT TO RECOVERY ROOM IN STABLE CONDITION. NO ADD'L SURGICAL INCISION WAS REQUIRED DURING RETRIEVAL OF THE BROKEN NEEDLE.
DEVICE REQUESTED FOR EVAL. UNKNOWN IF DEVICE WAS RETAINED FOR EVAL. REFERENCE MFR. COMPLAINT #Z96-306. 510K#=K930588. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCT HAS MALFUNCTIONED.
THE PRODUCT WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPROTEDLY, THE NEEDLE BROKE OUTSUIDE OF THE PT'S CAVITY. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE.
9/13/96 -MEDWATCH FORM NOT RECEIVED BY MFG.
THE DEVICE WAS APPLIED DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE INVOLVING ONE PT. REPORTEDLY THE SAFETY SHIELD WOULD NOT RETRACT. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
NURSE WAS ELEVATING THE HEAD OF A RESIDENT'S ELECTRIC BED AND OBSERVED A BURNING ODOR COMING FROM THE BED'S MOTOR. THE FACILITY INITIATED ITS FIRE PLAN EVACUATING RESIDENTS SAFELY. THE LOCAL FIRE DEPT DETERMINED THAT THE ELECTRIC BED'S MOTOR MALFUNCTIONED. THE BED WAS REMOVED FROM THE FACILITY. RESIDENT'S ROOM WAS AIRED OUT AND 1 HR LATER RESIDENT RETURNED TO ROOM IN ANOTHER BED. BED TAKEN OUT OF SVC.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SAFETY SHIELD DID NOT RETRACT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SAFETY SHIELD WOULD NOT RETRACT. THE HOSP REPORTED NO PT INJURY.
GASTROSTOMY TUBE GOT STUCK IN PT'S ABDOMEN. MD WAS UNABLE TO EXTRACT G-TUBE. ANOTHER MD WAS ABLE TO CUT THROUGH FASCIA AND LOOSEN G-TUBE. WHEN HE PULLED BACK ON G-TUBE, IT BROKE IN HALF. NEW G-TUBE (ANOTHER BRAND) WAS REINSERTED ORALLY THEN PULLED UP THROUGH THE STOMA USING THE GUIDE WIRE.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE DID NOT FIRE THROUGH AND COMPLETE THE STAPLE LINE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPY. REPORTEDLY, THE INSTRUMENT LEAKED. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
NURSE USING LATEX GLOVES, DEVELOPED INTENSE BURNING; ITCHING AND HIVES UP TO HER ELBOWS. WITHIN 2 MINS OF REMOVING GLOVES SHE HAD DEVELOPED SHORTNESS OF BREATH WITH INSPIRATORY AND EXPIRATORY WHEEZING, EDEMATOUS HANDS, ITCHY, WATERY EYES, NORMAL DISCHARGE AND SNEEZING. SHE CONSULTED A DR, WHO "DREW BLOOD" AND DIAGNOSED HER WITH LATEX HYPERSENSITIVITY.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE FIRED BUT THE STAPLES FAILED TO HOLD AND THE STAPLE LINE HAD COME. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, MOISTURE WAS INSIDE THE LENS. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT HOLD. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
9/13/96-MEDWATCH FORM NOT RECEIVED BY MFR.
DURING A PTCA PROCEDUE, THE BALLOON WOULD NOT DEFLATE. THEY CONTINUED TO PULL NEGATIVE PRESSURE UNTIL THE BALLOON DEFLATED ENOUGH TO REMOVE. NO PT INJURIES OR COMPLICATIONS OCCURRED.
THE BALLOON CATHETER WAS DISCARDED BY THE HOSPITAL, SO NO RETURNED PRODUCRT ANALYSIS WILL BE AVAILABLE.
PT WITH A DX OF CHRONIC PELVIC PAIN AND DYSMENORRHEA HAD ELECTIVE OUTPT DIAGNOSTIC LAPROSCOPY. UPON CLOSING THE FASCIA OF INCISION (2 CM ABOVE SYMPHYSIS PUBIS) WITH SUTURE, THE SUTURE NEEDLE BROKE OFF, WITH MORE THAN HALF OF THE NEEDLE LEFT IN THE PT'S ABDOMEN. (THE SURGEON RETRIEVED THE NEEDLE, GETTING STUCK BY THE NEEDLE WHILE DOING SO. HE WAS SEEN IN THE HOSPITAL'S EMERGENCY ROOM.) NO INJURY TO PT WHO WENT TO RECOVERY ROOM IN STABLE CONDITION. NOTE: PT #2 REFERS TO SURGEON'S NEEDLESTICK.
DEVICE REQUESTED FOR EVAL. UNKNOWN IF DEVICE WAS RETAINED FOR EVAL. REFERENCE MFR COMPLAINT #Z96-306. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
9/13/96 -MEDWATCH REPORT WAS NOT RECEIVED BY MFR.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, PNEUMOPERITONEUM LEAKED FORM THE INSTRUMENT. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE EVENT OCCURED AT A WORK SHOP AT THE DISTRIBUTION CENTER. UPON INJECTION OF CEMENT, THE NOZZLE DISSOCIATED FROM DEVICE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, THEREFORE THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
THE ROOT CAUSE IS ATTRIBUTED TO A LESS THEN OPTIMUM WELD OF THE EXTENDER TUBE AND NOZZLE BODY. THE PROCESS TOOLING HAS BEEN IMPROVED TO PRECLUDE THIS CONDITION.
THE TUBING DISCONNECTED FORM THE TRANSDUCER ALLOWING FLUIDS TO LEAK.
CUSTOMER INDICATED PRODUCT WOULD BE RETURNED FOR EVAL. PRODUCT HAS NOT BEEN RECEIVED. ADD'L INFO WILL BE PROVIDED IF PRODUCT RETURNED. RETURNED SAMPLES WERE EVALUATED AND WERE FOUND TO BE ACCEPTABLE. LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE.
THE NAIL BROKE TWO MONTHS POST-OP AND WAS REMOVED. NO CLINICAL INFO FOR THE PT WAS PROVIDED AT THIS TIME. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
HARDNESS INSPECTION SHOWS THE NAIL TO BE IN COMPLIANCE WITH SPECIFICATIONS. NO MATERIAL FAULT COULD BE FOUND. THE CORRECT STRENGTH OF THE NAIL AND THE FEATURES OF THE FRACTURE SUGGEST THE NAIL FRACTURED DUE TO MATERIAL FATIGUE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE INSTRUMENT BROKE. THE SURGEON COMPLETED THE PROCEDURE WITHOUT INCIDENT.
THE TIBIAL INSERT WOULD NOT LOCK INTO THE BASEPLATE. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME,
H4: THE DEVICE MFR DATE IS 5/30/96. EVALUATION: THE TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE ANTERIOR LOCKING TAB EXHIBITS GROSS DISTORTION DUE TO HAVING BEEN CRUSHED BY THE LOCKING POST OF THE BASEPLATE DURING THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. A QUERY OF THE PRODUCT EXPERIENCE REPORT DATABASE FOUND THAT NO OTHER SIMILAR EVENT HAS BEEN REPORTED FOR THIS LOT OF INSERTS. THE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES. IMPACTION OF A MISALIGNED INSERT DAMAGES THE ANTERIOR LOCKING TAB WHICH THEN PRECLUDES PROPER ASSEMBLY TO THE BASEPLATE.
DR SAT ON FOOT SECTION OF BED TO TILT. PT SLID TO FOOT END OF BED AND DR FELL ON TO THE FLOOR.
INVESTIGATION INTO THE INCIDENT REVEALED THAT THE BOLTS WHICH HOLD THE INTERMEDIATE FRAME TO THE HEAD-SECTION LIFT ARMS HAD BACKED OUT. THE INVESTIGATION IS FOCUSING ON CAUSE AND WHETHER THE EVENT IS ISOLATED OR MORE WIDESPREAD.
THE DEVICE WAS APPLIED DURING A COLOSTOMY TAKESDOWN. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A TONSILLECTOMY PROCEDURE, THE MECHANISM THAT CONTROLS THE LOCK ON THIS MOUTH GAG WAS NOT WORKING CORRECTLY AND A CRACK COULD BE SEEN. ANOTHER GAG WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. THUMB LATCH WAS FOUND TO BE CRACKED. SPRING WAS FOUND TO BE BROKEN.
THE PRODUCT WAS USED DURING A COLECTOMY PROCEDURE. REPORTEDLY, THE SUTURE KNOT UNTIED. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SUTURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
9/13/96 -MEDWATCH REPORT WAS NOT RECEIVED BY THE MFG.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F/13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. THUMB LATCH WAS FOUND TO BE CRACKED. SPRING WAS FOUND TO BE BROKEN.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON MANUALLY MANIPULATED THE JAWS OPEN AND NOTICED THAT THE SEVERAL STAPLES WERE NOT FIRED AND THE KNIFE DID NOT ADVANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE HOSP HAS REPORTED NO PT INJURY.
THE DEVICE STOPPED OSCILLATING AND COULD NOT BE RESTRTED. IT WAS DETERMINED THAT THE CAP/DIAPHRAGM WAS THE CAUSE. THE VENTILATOR WAS ON A PT. THE PT WAS NOT COMPROMISED AT ALL.
DEVICE PMA# P890057. IS FREQUENCY ADDRESSED IN LABELING? NO. FREQUENCY GREATER THAN USUAL? U. IS SEVERITY ADDRESS IN LABELING.? NO. SEVERITY GREATER THAN USUAL? UNK.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
1/27/97-SUPPLEMENTAL REPORT #1. IT HAS COME TO CO'S ATTENTION THAT THIS EVENT IS NOT REPORTABLE UNDER THE MDR REGULATION AS A MALFUNCTION MDR. PLEASE DISREGARD THE EVENT SUBMITTED UNDER THIS REFERENCE NUMBER.
THE DEVICE WAS USED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE HOSP REPORTED NO PT INJURY.
THE DEVICE WAS APPLIED DURING A TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE VENTILATOR DID NOT PASS THE PERFORMANCE TEST. THE DELTA PA WAS 56 CMH20 THEN DROPPED TO 44 CMH20. THE SPEC FOR DETA P IS 56 TI 65 CMH20. THERE WAS NO PT INVOLVEMENT AT ALL.
DEVICE PMA# P890057. IS FREQUENCY ADDRESSED IN LABELING? N. FREQUENCY GREATER THAN USUAL? U. IS SEVERITY ADDRESSED IN LABELING? N. SEVERITY GREATER THAN USUAL? UNK.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE CARTRIDGE JAMMED. THE SURGEON CAUTERIZED TO COMPLETE THE PROCEDURE.
10/24/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA BY MFG. ADDITIONAL INFORMATION DATA SUBMITTED FOR D7 AND D8. DEVICE EVALUATION INDICATED AND DOES ENTERED IN H3 AND H6.
THE DEVICE WAS APPLIED DURING A RIGHT HEMI CHOLECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY WITH THE FOURTH DISPOSABLE LOADING UNIT. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HSOP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A CATARACT EXTRACTION PROCEDURE, HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
THE OSCILLATOR OF VENTILATOR WAS SKIPPING WHEN THE POWER OR PISTON CENTERING KNOBS WERE ADJUSTED. THERE WAS NO PT INVOLVEMENT AT ALL.
DEVICE PMA# P890057. IS FREQUENCY ADDRESSED IN LABELING? N. FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? N. SEVERITY GREATER THAN USUAL? UNK. A FIELD SVC REP WAS SENT TO TH CUSTOMER'S SITE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
9/13/96 -INTERNATIONAL MEDWATCH REPORT NOT RECEIVED BY MFG.
CUSTOMER COMPLAINT WAS NOT DUPLICATED; HOWEVER, THE ASPIRATION TUBE WAS BENT, THE IRRIGATION TUBE WAS TWISTED AND THE RING HOLDING THE IRRIGATION TUBE TO THE BODY OF THE HANDPIECE WAS STRETCHED.
THE DEVIE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. REPORTEDLY, ON THE FIFTH FIRING THE STAPLES DID NOT FORM PROPERLY AND THE TISSUE WAS NOT CUT. THE SURGEON CAUTERIZED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT JAMMED AND WOULD NOT OPEN. THE SURGEON CAUTERIZED TO COMPLETE THE PROCEDURE.
THE DEVICE WAS APPLIED DUR8NG A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
9/13/96 -MEDWATCH REPORT NOT RECEIVED BY MFG.
DURING A CATARACT EXTRACTION PROCEDURE, FLAKES OF METAL WERE SEEN ON THE OUTSIDE OF THE EYE ON THE SCLERA. ALL PARTICULATE WAS ASPIRATED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. THIS PHACOFRAGMENTATION HANDPIECE DOES NOT IRRIGATE AND UNDER NORMAL WORKING CONDITIONS THERE WOULD BE NO FLOW OUT FROM THE HANDPIECE. ALTHOUGH THE HANDPIECE FAILED THE EXCURSION TEST, THIS WOULD NOT BE LIKELY TO CAUSE PARTICULATE.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. REPORTEDLY, A COMPONENT DISSENGAGED FROM THE RETAINING PIN. THE SURGEON RETRIEVED THE COMPONENT WITHOUT INCIDENT.
THE DEVICE WAS APPLIED DURING A VATS LOBECTOMY PROCEDURE. REPORTEDLY, BLEEDING WAS OBSERVED.
10/03/96-SUBMISSION OF SUPPLEMENTAL REPORT WITH DEVICE EVALUATION INDICATED AND ENTERED IN H-3 AND H-6.
THE SET SCREW ON THE POWER KNOB HAD BEEN STRIPPED AND IT COULD NOT BE TIGHTENED ON THE POTENTIOMETER SHAFT. THERE WAS NO PT INVOLVEMENT AT ALL.
DEVICE PMA# P890057. IS FREQUENCY ADDRESSED IN LABELING? NO. FREQUENCY GREATER THAN LABELING? FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. SEVERITY GREATER THAN USUAL? UNK.
THE DEVICE WAS APPLIED DURING A GASTRECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON MANUALLY SUTURED THE ANASTOMSIS TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
6/5/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
A TRACHEOSTOMY TUBE WAS IN SITU ON A MENTALLY HANDICAPPED PT. THE TRACHEOSTOMY TUBE ALLEGEDLY BECAME DISLODGED; THE PT WENT INTO RESPIRATORY DISTRESS AND EXPIRED. IT IS REPORTED THAT THE STRINGS WERE TIED TO THE TRACHEOSTOMY TUBE COLLAR AND THE TUBE WAS OUT OF PLACE AND WAS LYING NEAR THE MEDIAL END OF THE PT'S RIGHT COLLAR BONE. THERE IS NO EVIDENCE THAT THERE WAS ANY PROBLEM OR DEFECT IN THE TRACHEOSTOMY TUBE OR STRING TIE THAT CAUSED OR CONTRIBUTED TO THE DEATH OF THIS PT.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FDA BY CO. PURSUANT TO 21.C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AN ADMISSION BY THE CO THAT A CO'S DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A CO'S DEVICE AND A REPORTED DEATH OR SERIOUS INJURY.
AFTER BEING PLACED ON CATHETER IN THE RADIAL VEIN DURING THREE DAYS IT LOOSES LIQUID AT THE SITE. WHEN TRYING TO WITHDRAW IT, IT SEPARATED AND THE CATHETER HAD TO BE TAKEN OUT BY A SURGERY." NO FURTHER INFO WAS AVAILABLE. WITH THE SOURCE STATING SHE DID NOT WANT TO REVEAL CONFIDENTIAL INFO.
ONLY THE CATHETER PORTION OF THE DEVICE WAS RETURNED FOR EVALUATION. THE HUB OF THE CATHETER WAS NOT AVAILABLE FOR INSPECTION. THE PORTION OF DEVICE RETURNED WAS EXAMINED BY A CO'S INTERNATIONAL FACILITY. VISUAL INSPECTION STATEMENT READS, "FROM ITS APPEARANCE IT LOOKED AS IF THE CATHETER HAD BEEN RIPPED OR TORN FROM THE HUB." THE CATHETER HAD BEEN IN USE AND FUNCTIONING WITHOUT REPORTED PROBLEMS FOR THREE DAYS PRIOR TO THIS REPORTED EVENT. THERE IS NO INFO AVAILABLE REGARDING HOW THE DEVICE WAS BEING USED, IF AN IV WAS CONNECTED, IF THE DEVICE WAS ENTERED WITH A NEEDLE, ETC. THEREFORE, NO CONCLUSION CAN BE DRAWN FROM THE AVAILABLE INFO.
DURING A CATARACT EXTRACTION PROCEDURE, HANDPIECE WAS NOT FUNCTIONING AS WELL AS IT SHOULD. THIS HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. THE ASPIRATION TUBE ON THIS HANDPIECE WAS FOUND TO BE BENT.
X-TUBE ASSM 20" X 13". DEALER CLAIMS: BROKEN X TUBE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEED CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A CATARACT EXTRACTION PROCEDURE, HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
REAR S/F PNTD R Z2. DEALER CLAIMS: BROKEN RIGHT REAR SIDE FRAME, AND THE LEFT REAR SIDE FRAME IS CRACKED.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS APPLIED DURING THE CLOSURE OF THE ABDOMINAL CAVITY ON AN ANIMAL. REPORTEDLY, SWELLING WAS OBSERVED AT THE SITE OF THE INCISION.
THE DEVICE WAS APPLIED DURING A SUB-TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY THE STAPLES DID NOT FORM PROPERLY. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER INSTRUMENT.
THE UNIT OVERFILLED THE FINAL CONTAINER FROM THE SOURCE CONTAINER ON THE GREEN STATION. THE VOLUME DISPLAY STOPPED AT 45ML BUT PUMPING CONTINUED. THE USER HIT THE STOP/MUTE BUTTON AFTER AN ESTIMATED 250ML HAD BEEN PUMPED INTO THE FINAL CONTAINER. THE CALLER DID NOT KNOW WHAT VOLUME HAD BEEN PROGRAMMED. HE THOUGHT ALL SPECIFIC GRAVITIES HAD BEEN SET AT 0.99. THERE WERE NO ALARMS NOR ANY CALIBRATION PROBLEMS. NO OTHER INFO WAS AVAILABLE. THE USER SAID THAT AFTER THIS INCIDENT, HE RESET THE UNIT AND THE LOAD CELL DID NOT RESPOND WHEN HE HUNG THE 1000 GM WEIGHT. THE UNIT WAS TAKEN OUT OF SERVICE AND SENT TO THE TESTING LABORATORY. NO PT INVOLVEMENT.
SECTION F COMPLETED BY CO, BASED ON INFO OBTAINED FROM REPORTER. EVALUATION: THE UNIT WAS RECEIVED DIRTY FROM SOLUTION SPILLS AND WAS TESTED AS RECEIVED. ACCURACY TESTS COULD NOT BE RUN UNTIL DEFECTIVE MEMBRANE SWITCH PANEL WAS REPLACED. THE UNIT PASSED LOAD CELL TESTS, FURTHER TESTING WAS SUSPENDED UNTIL THE REPAIR OF THE MEMBRANE SWITCH. AFTER THE REPAIR, THE UNIT COMPLETED AND PASSED ALL TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
THE SURGEON NOTICED WHAT HE BELIEVED WAS CONDENSATION ON HIS EYE-WEAR FACE-SHIELD. UPON FURTHER INSPECTION, THE SURGICAL TEAM REALIZED THAT IT WAS AN OILY BUILD UP. AT THAT POINT THE SCRUB NURSE INSPECTED THE DRILL MOTOR. SHE RAN THE DRILL MOTOR AND ADJUSTED THE ANGULAR POSITION WHILE HOLDING HER HAND OVER THE MOTOR AND SOON DETECTED A SLIGHT OILY RESIDUE ON HER HAND. THE REPORTED INCIDENT OCCURRED WHILE THE PT WAS ON THE OPERATING TABLE FOR A LAMINECTOMY, BUT PRECEDING ENTRY TO THE DURA. SUSPECTING THAT THE OILY MIST MAY HAVE INVADED THE STERILE FIELDS, THE SURGICAL SITE WAS IRRIGATED. THE STERILE FIELD WAS RE-DRAPED AND THEN A DECISION WAS MADE TO ABORT THE PROCEDURE. THE PT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS. THE PT WAS PLACED UNDER OBSERVATION AND THE SURGERY RESCHEDULED FOR A LATER DATE.
CO'S RESPONSIBILITY TO THE CUSTOMER IS TO MAKE SURE THE PRODUCT MEETS PERFORMANCE SPECS. THE DRILL MOTOR IS SUCCESSFULLY BEING USED IN THE HEALTH CARE INDUSTRY FOR A VARIETY OF APPROVED APPLICATIONS WITH A RECORD OF SUCCESS. THE EXPECTED FREQUENCY OF THIS TYPE OF OCCURRENCE IS NOT TO OCCUR AT ALL. IN THE WORST CAST SCENARIO OF FREQUENCY OF OCCURRENCE IS VERY LOW. THIS TYPE OF OCCURRENCE CAN ONLY BE ATTRIBUTED TO THE AGE OF THE DEVICE AND THE MAINTENANCE CARE PROGRAM PROVIDED. THIS TYPE OF OCCURRENCE CAN BE AVOIDED BY PROPER CARE AND MAINTENANCE OF THE MOTOR. THIS IS AN EXTREMELY ISOLATED INCIDENT FOR THE NUMBER OF PNEUMATIC DRILL MOTORS IN USE ON A DAILY BASIS WORLD WIDE. THE SEVERITY OF THIS TYPE OF INCIDENT IS UNPREDICTABLE. THE PT IN THIS CASE AT THE TIME OF THIS REPORT HAS HAD NO ADVERSE EFFECTS FROM THE INCIDENT. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE USER FACILITY, MFR, OR PRODUCT CAUSED THE EVENT. THIS REPORT CONTAINS INFO REPORTED TO MIDAS REX PNEUMATIC TOOLS, INC. AND MAY NOT CONTAIN OUR REPRESENTATION OF THE FACTS AFTER FURTHER INVESTIGATION. NEITHER THE SUBMISSION OF THIS NOR OTHER INFO TO THE FDA, NOR PUBLIC RELEASES OF SUCH INFO, CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED, OR ESTABLISHES THE EXISTENCE OF ANY CONNECTION BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
WHILE PREPPING THE BALLOON THE HUB OF THE DEVICE BROKE OFF. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR ANALYSIS.
DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE INSTRUMENT BROKE. THE SURGEON COMPLETED THE PROCEDURE WITHOUT INCIDENT.
DURING A DIAGNOSTIC PROCEDURE THE SHAFT OF THIS DEVICE SPLIT. REPORTEDLY, AS THE PHYSICIAN ATTEMPTED TO POWER INJECT A HOLE "POPPED" INTO THE SHAFT OF THE CATHETER. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE.
DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE INSTRUMENT BROKE PRIOR TO INTRODUCTION. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER INSTRUMENT.
DURING AN UNSPECIFIED PROCEDURE, THE SEAL DISENGAGED PRIOR TO USE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REORTED NO PT INJURY.
REAR S/F DAB PNTD L Q2. DEALER CLAIMS BROKE ABOVE WELD.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OFTHAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
Q2 DAB BACK FRAME LEFT SIDE. DEALER CLAIMS BROKEN LEFT SIDE FRAME DAB.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTH4ER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE  DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
A POWER SURGE DURING THE PROCEDURE RESULTED IN A STRONGER BURN TO THE RETINA.
THIS PRODUCT HAD BEEN RECALLED. ORIGINAL RETROFIT ON 4/10/96 WAS PERFORMED INCORRECTLY BY FOREIGN FIELD ENGINEER. THE RETROFIT WAS PERFORMED CORRECTLY ON 8/8/96. PT INFO HAS BEEN REQUESTED FROM THE REPORTER BUT HAS NOT BEEN RECEIVED TO DATE. THE MFR'S INTERNAL REFERENCE NUMBER IS 8-8799-96.
DEALER ALLEGES THE X-TUBE BROKE AT THE CENTER BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THERE WAS AN INTERMITTENT NO ALARM CONDITION. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND FOUND A LOOSE CONNECTION AT THE POWER SWITCH THE CSE TIGHTENED THE CONNECTION AT THE POWER SWITCH. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE ALARM ITSELF MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THE REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE AUDIBLE ALARM FAILED IN FUNCTION. THE CUSTOMER'S BIO-MED TECHNICIAN INSPECTED THE UNIT AND REPORTED THAT HE FOUND A CONNECTOR UNSEATED. HE REATTACHED THE CONNECTOR AND THE UNIT BEGAN FUNCTIONING PROPERLY. IT WAS UNDETERMINED HOW THE CABLE BECAME DETACHED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
CAR ACCIDENT ON 7/25/96. ADMITTED ON 7/26/96 FOR OPEN BOOK FRACTURE, PELVIS, HUMERAL FRACTURE & FEMORAL FRACTURE. DURING EXTERNAL FIXATION APPLICATION, SURGEON COULD NOT GET THE PELVIC SCREW PROPERLY SEATED IN THE BONE. SURGEON FELT HE DRILLED THE SCREW TO MEDIAL IN THE PELVIC AND DESTROYED THE BONE.
THE VALVE WAS ELECTIVELY REPLACED, AND THEN SENT TO CO FOR EVALUATION. UPON EXAMINATION AT CO, A SINGLE LEG SEPARATION WAS NOTED.
THE LEFT LEG OF THE OUTLET STRUT WAS SEPARATED FROM THE FLANGE. THE RIGHT LEG WAS FOUND TO BE INTACT. THE VALVE WAS NOTED TO BE FULLY FUNCTIONAL. THIS REPORT SUMMARIZES THE EVALUATION OF THE CO'S MITRAL PROSTHETIC HEART VALVE, ASSIGNED SERIAL NUMBER 33MBRC10383 THAT WAS RETURNED TO CO FOR ANALYSIS. THE VALVE HAD BEEN IMPLANTED FOR 14 YEARS, 10 MOS. DISC: CONCENTRIC WEAR PATTERNS WERE OBSERVED ON THE CONCAVE SURFACE OF THE DISC. THESE PATTERNS INDICATED THAT THE DISC ROTATED NORMALLY DURING VALVE OPERATION. ON THE OUTFLOW SIDE, THE DISC WELL DISPLAYED A POLISHED WEAR PATTERN THAT WAS PRODUCED BY THE TIP OF THE OUTLET STRUT. THIS WEAR IS TYPICAL FOR A VALVE IMPLANTED FOR OVER FOURTEEN YEARS. WEAR MARKS WERE OBSERVED IN VARIOUS LOCATIONS ALONG THE INNER DIAMETER. THESE WEAR MARKS WERE CAUSED BY CONTACT BETWEEN THE DISC AND THE ORIFICE RING AND ARE EXPECTED DURING NORMAL OPERATON OF THE VALVE. HOWEVER, SOME OF THE WEAR MARKS SUGGEST THAT THE DISC HAD AT LEAST TWO CLOSED POSITIONS. SCRATCHES WERE OBSERVED AT VARIOUS LOCATIONS ON THE FLANGE AND MAY HAVE BEEN CAUSED BY SURGICAL INSTRUMENTS DURING EXPLANTAION OF THE VALVE. INLET STRUT: POLISHED WEAR MARKS WERE OBSERVED ON THE SURFACE OF THE INLET STRUT WHICH CONTACTS THE CONCAVE SURFACE OF THE DISC. WEAR PATTERNS ON THESE SURFACES ARE ANTICIPATED WITH NORMAL OPERATION OF THE VALVE. OUTLET STRUT: WEAR MARKS WERE OBSERVED AT THE TIP OF THE OUTLET STRUT. THESE WEAR MARKS ARE CAUSED BY CONTACT BETWEEN THE DISC AND OUTLET STRUT DURING VALVE OPERATION. THE RELATIVELY LARGE WEAR MARK CORRESPONDING TO THE CLOSED DISC POSITIONS INDICATES AN OVERLOAD CONDITION EXISTED DURING SOME CLOSING CYCLES. THE SEM EXAMINATION SHOWED THE SINGLE LEG SEPARATION OF THE LEFT OUTLET STRUT LEG. THE SEM PHOTOS OF THE RIGHT OUTLET STRUT WELD SHOWED NO EVIDENCE OF FATIGUE OR DEGRADATION. THE VALVE WAS FULLY FUNCTIONAL DESPITE THE PRESENCE OF THE SINGLE LEG SEPARATION.
THE UNIT WAS NOT FUNCTIONING TO SPECIFICATION. THE CUSTOMER SUPPORT ENGINEER VERIFIED THAT THERE WAS A PRESSURE LEAK IN THE POSITIVE END EXPIRATORY PRESSURE (PEEP) CIRCUIT. THE UNIT BEGAN TO SELF-CYCLE AFTER SIXTY SECONDS WITH A SENSITIVITY OF 1 AND 10 CMH20 PEEP. THE CSE INSPECTED THE DEVICE AND REPLACED THE AUTOZERO SOLENOIDS AND EXHALATION VALVE. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
UNDERDELIVERY REPORTED. THE PUMP HAD BEEN IN USE WITH A FLOW DETECTOR AND REPEATED ALARMS FOR "LOW FLOW" OCCURRED. IT WAS THOUGHT THAT THE FLOW DETECTOR WAS NOT OPERATING PROPERLY, SO IT WAS REMOVED AND THE DEVICE WAS PROGRAMMED TO DELIVER WITH A DOSE LIMIT. THE PUMP WAS SET TO ADMINISTER AND UNSPECIFIED MAINTENANCE FLUID WITH AN UNSPECIFIED  AMOUNT OF POTASSIUM CHLORIDE AT 300 ML/HR. WHEN THE NURSE CHECKED THE INFUSION AFTER ONE HR, ONLY 100 ML HAD INFUSED. THE REPORTED UNDERDELIVERY DID NOT CAUSE ANY ADVERSE PT EFFECTS.
THE REPORT OF UNDERDELIVERY COULD NOT BE DUPLICATED. THE UNIT HOWEVER, FAILED OCCLUSION PRESSURE TESTING WHICH IS NOT RELATED TO THE COMPLAINT. THE FREQUENCY OF OCCURRENCE OF DEATH OR SERIOUS INJURY FOR UNDERDELIVERY COMPLAINTS FOR LIFECARE IS APPROX. .48/MILLION SETS USED.
NEEDLE DETACHED DURING THORACIC SURGERY. NO OTHER INFO SUPPLIED.
INVESTIGATION IS COMPLETE. REFERENCE MFR COMPLAINT #G96-164. 510K = K930587. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD AND GECK TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED. CODE 86 -LOT HISTORY WAS CHECKED, ALL FINDINGS WITHIN USP SPECS. RETURNED SAMPLES WERE EVALUATED, NO DEFECTS RELATED TO COMPLAINT WERE OBSERVED. NEEDLE HOLDING STRENGTH WAS TESTED AND FOUND TO BE SIMILAR TO ORIGINAL RESULTS AND WELL WITHIN USP REQUIREMENTS. NO OTHER REPORTS HAVE BEEN RECEIVED REGARDING THIS LOT SINCE ITS RELEASE ON 7/5/95.
CONSUMER ALLEGES FIRST CONDOM BROKE ON INSERTION AND HE NOTICED A HOLE IN SECOND CONDOM AFTER COMPLETION. CONSUMER IS CONCERNED ABOUT THE POSSIBILITY OF CONTACTING HERPES AND A POTENTIAL PREGNANCY AFTER HAVING INTERCOURSE WITH A FEMALE PARTNER THAT MAY HAVE HAD AN ACTIVE HERPES LESION. HE STATED THAT HE HAD NOT SOUGHT A MEDICAL OPINION.
A PT EXPERIENCED RESPIRATORY DISTRESS WHILE CONNECTED TO VENTILATOR. THE CUSTOMER STATED THAT THE VENTILATOR WAS AUTOCYCLING WHEN THE PEEP FUNCTION WAS USED. ALTHOUGH THE ATTENDING PHYSICIAN DID STATE THAT THERE WAS NO PT INJURY HE DID FEEL THAT HAD THE VENTILATOR NOT BEEN REMOVED THE PT'S HEALTH COULD HAVE BEEN COMPROMISED. CUSTOMER SERVICE ENGINEER INSPECTED THE UNIT AND VERIFIED THE REPORTED MALFUNCTION. THE CSE REMOVED AND REPLACED THE EXHALATION VALVE. THE UNIT PASSED ITS TOTAL EXTENDED SELF TEST. THIS REPORT IS NOT AN ADMISSION BY CO TO THE VENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE PUMP REPORTEDLY FAILED VOLUME ACCURACY TESTING (UNDERDELIVERED) AS PERFORMED BY THE HOSPITAL BIOMEDICAL ENGINEERING DEPT. THE EXPECTED DELIVERY VOLUME WS 20.0 ML WITH SPECIFICATION LIMITS OF 19.0 ML TO 21.0 ML. THE DEVICE DELIVERED 17 ML. THERE WAS NO PT INVOLVEMENT. THERE WERE NO REPORTS OF ANY PT EVENTS WHEN THE DEVICE WAS IN USE.
THE DEVICE WAS RECEIVED FOR TESTING AND ANALYSIS ON 8/22/96. TESTING IS NOT COMPLETE.
THERE WAS NO AUDIBLE ALARM. THE CUSTOMER SUPPORT ENGINEER VERIFIED THAT THE ALARM WAS INTERMITTENT. THE CSE INSPECTED THE DEVICE AND REPLACED THE AUDIO ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THEIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
REPORT OF ALLEGED "CONTINUOUS STOP CYCLE, WITH ALL LEDS AND AUDIBLE ALARMS. NO PT HARM."
TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL.
X-TUBE ASSM 18" X 16". DEALER CLAIMS THE CROSS FRAME IS BROKEN AT THE CTR OF THE HINGE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE EPIDURAL NEEDLE AND CATHETER WERE PLACED IN THE PT. THE CATHETER COULD NOT BE ADVANCED TO THE DESIRED LOCATION. THE NEEDLE AND CATHETER WERE ATTEMPTED TO BE REMOVED SIMULTANEOUSLY. WHEN THE NEEDLE AND CATHETER WERE REMOVED, IT WAS NOTICED THAT THE CATHETER TIP WAS MISSING. AN UNSUCCESSFUL ATTEMPT TO RETRIEVE THE CATHETER TIP WAS MADE.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FOOD AND DRUG ADMINISTRATION BY SIMS, INC. PURSUANT TO 21 CFR -ART 803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AN ADMISSION BY THE CO THAT A SIMS DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. A.1. CO'S FOLLOW-UP WITH HOSP PERSONNEL REVEALS THAT A PT INDENTIFIER HAS NOT YET BEEN DETERMINED. H.6. (RESULTS) CODE 100 -NO DEVICE FAILURE. CO'S VISUAL EXAMINATION OF THE RETURNED CATHETER REVEALED THAT THE CATHETER WAS SHEARED. THE ANGLE OF THE CATHETER SHEAR IS CONSISTENT WITH THE CATHETER BEING PULLED BACK THROUGH THE NEEDLE. DIMENSIONAL READINGS AT THE SHEARED END OF THE CATHETER REVEAL A .005" REDUCTION WHICH IS CONSISTENT WITH THE CATHETER BEING INITIALLY CAUGHT AGAINST THE NEEDLE BEVEL. THEN STRETCHED AND ULTIMATELY SHEARED. CO'S DIRECTIONS FOR USE STATE THE FOLLOWING PRECAUTION: "DO NOT PULL CATHETER BACK THROUGH THE EPIDURAL NEEDLE DUE TO POSSIBLE DANGER OF SHEARING."
POSSIBLE OVERDELIVERY REPORTED. THE PUMP WAS INFUSING AN UNSPECIFIED SOLUTION AT AN UNSPECIFIED RATE. WHEN THE 1000 ML CONTAINER WAS EMPTY, THE DISPLAY READ 860 ML DELIVERED. IT WAS NOT KNOWN IF THE DELIVERED VOLUME HAD BEEN CLEARED AT ANY TIME. THE TIME PERIOD OVER WHICH THE DELIVERY TOOK PLACE WAS NOT RECORDED. THE NURSE WHO MADE THE REPORT WAS NOT IDENTIFIED, AND FURTHER INFO WAS NOT AVAILABLE. THE REPORTED OVERDELIVERY OF 140 ML DID NOT CAUSE ANY ADVERSE PT EFFECTS.
THE DEVICE WAS RECEIVED FOR ANALYSIS ON 8/20/96. TESTING IS NOT COMPLETE.
THE HIGH PRESSURE ALARM FAILED TO ACTIVATE WHILE PERFORMING AN INCOMING EVALUATION OF THE DEVICE. THE SERVICE TECHNICIAN INSPECTED THE DEVICE AND ADJUSTED THE HIGH PRESSURE ALARM CIRCUIT. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
REPORT OF ALLEGED "ALL LEDS ON, SINGLE TONE ALARM, NO VOLUME DELIVERED, CONTINUOUS REBOOT. NO PT HARM."
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F. TESTING BY MFR FOUND A CONTINUOUS CYCLE, NO VOLUME DELIVERED, WITH AUDIBLE AND VISUAL ALARMS, DUE TO MAGNETIC SENSOR BEING OUT OF SPEC. REPLACED MAGNETIC SENSOR.
THE SERVICE REPORT SHOWS THAT WHILE PERFORMING AN INCOMING EVALUATION, THE DEVICE FAILED TO SWITCH FROM AC POWER TO INTERNAL BATTERY POWER WITHIN SPECIFICATIONS. THE SERVICE TECHNICIAN INSPECTED THE DEVICE AND REPLACED THE BATTERY PACK. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
X-TUBE ASSM 16" X 16" DEALER CLAIMS IT'S BROKEN AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 03, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REPORT OF ALLEGED "OCCASIONALLY MISSED CYCLE."
THE LOW PRESSURE ALARM DOES NOT ALARM. THE SERVICE TECHNICIAN VERIFIED THAT THE LOW PRESSURE ALARM WAS OUT OF SPECIFICATION. THE ST INSPECTED THE DEVICE AND ADJUSTED THE LOW PRESSURE KNOB. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE VENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIE EVENT HAS OCCURRED AAT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE DEVICE FAILED THE LEAK TEST DURING INCOMING EVALUATION. THE SERVICE TECHNICIAN INSPECTED THE DEVICE AND TIGHTENED THE PISTON GUIDES. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
REPORT OF ALLEGED "UNIT DOES NOT ALARM LOW PRESSURE/APNEA WHEN DISCONNECT FROM PT. NO PT HARM."
X-TBE ASSM 18" X 16". CUSTOMER CLAIMS THE X-TUBE IS BROKEN AT THE BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE SERVICE REPORT SHOWS THAT WHILE PERFORMING AN INCOMING EVALUATION OF THE DEVICE, THE VOLUMES WERE FOUND TO BE OUT OF SPECIFICATION. THE SERVICE TECHNICIAN INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
UNDERDELIVERY REPORTED. THE PUMP WAS SET FOR HOME INFUSION OF DOBUTAMINE 500 MG/250 ML D5W AT 13.5 ML/HR. THE EXPECTED DELIVERY TIME WAS 18 HRS BUT THE INFUSION TOOK 21 HRS TO COMPLETE. BY THE TIME THE I.V. CONTAINER WAS EMPTY, THE PT EXPERIENCED SOME "SHORTNESS OF BREATH AND A LOW BLOOD PRESSURE." THE PUMP WAS SWITCHED OUT AND A NEW INFUSION STARTED. AFTER A SHORT PERIOD OF TIME THE ABOVE SYMPTOMS RESOLVED. THERE WERE NO ADVERSE SEQUELAE REPORTED.
CUSTOMER SET WAS NOT RETURNED FOR TESTING. PUMP INFUSED WITHIN SPECIFICATIONS.
REPORT OF ALLEGED "UNIT DOES NOT CYCLE, ALL LEDS, CONSTANT AUDIBLE ALARM. NOT IN PT USE."
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F. TESTING BY MFR FOUND UNIT WOULD NOT CYCLE, WITHALL LEDS AND A CONSTANT SINGLE TONE AUDIBLE ALARM, DUE TO INTEGRATED CIRCUIT U8 ON THE LOGIC BOARD BEING OUT OF SPEC. REPLACED U8.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT LOSS OF APPROX 3LB. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINED IN THIS COMPLAINT SHOWS THAT A SIMILAR CONDITION OCCURRED IN 10/95. HOWEVER, THESE COMPLAINTS WERE TRACED TO A LEAKING P-3 CONNECTOR. THIS IS NOT RELATED TO THE FAILURE IN THIS COMPLAINT. THE HISTORY ALSO SHOWS A SECOND COMPLAINT FOR THE THERMAL FUSE. THE SAME FUSE FAILURE AFFECTED TWO PTS: THIS COMPLAINT ADDRESSES THE FIRST PT INCIDENT, AND COMPLAINT #0996047 ADDRESSES THE SECOND PT INCIDENT. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: N. SALES/SERVIDE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
X-TUBE ASSM 16" X 16" . CUSTOMER SAYS THE TOP OF THE X-TUBE IS BROKEN.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE, INC, OR ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE PRESSURE FLUCTUATES BETWEEN 5CM AND 10CM. THE SERVICE TECHNICIAN VERIFIED THE PRESSURE FLUCTUATIONS AND THAT THE VOLUMES WERE OUT OF SPECIFICATION. THE ST INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE  UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
CODE 000: CUP SEAL. BASED UPON ONFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
REPORT OF ALLEGED "ALL LEDS, SINGLE TONE AUDIBLE ALARM, DEVICE WOULD NOT CYCLE. NO PT HARM."
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F.  TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL. EVIDENCE OF LIQUID SPILL.
PRODUCT COULD NOT COLLECT BLOOD BECAUSE THE BLOOD LEAKES FROM THE CONNECTION BETWEEN THE BOTTLE COVER & THE EVACUATOR TUBE WITH RED SLIDE CLAMP. (ABOUT 4 HRS AFTER PLACEMENT)IT WAS REPLACED BY ANOTHER PRODUCT AND PT HAS NO PROBLEMS.
THE LEAD WAS EXPLANTED ELECTIVELY. POST EXPLANT THE PYHYSICIAN NOTED THE LEAD FRACTURED WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
X-TUBE ASSM 18" X 16" DEALER CLAIMS THE X-TUBE IS BROKEN/CRACKED ON THE LEFT SIDE SITTING IN CHAIR AT THE TOP.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS,INC., ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING PERIODIC TESTING, AN INTERMITTENT CHARGE MALFUNCTION WAS OBSERVED. REPORTEDLY, THE UNIT WAS OBSERVED TO CHARGE TO 5 JOULES WHILE A HIGHER ENERGY SETTING WAS SELECTED.
THE UNIT WAS TESTED AND FOUND TO OPERATE NORMALLY DURING REPEATED PERFORMANCE AND FUNCTIONAL TESTING. THE MAIN PCB AND PADDLES ASSEMBLIES WERE REPLACED AS A PREVENTATIVE MEASURE. THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF LOSS OF CAPTURE.
THIS ENTIRE FORM COMPLETED BY MFR. UNABLE TO PERFORM ANALYSIS, ELECTRODE PARTIALLY RETURNED. THE LEAD WAS RECEIVED IN A PARTIAL PROXIMAL 27CM PORTION WITH NO PORTION OF THE J STIFFENER WIRE ALONG WITH NO COIL WIRE FRACTURES OBSERVED. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES LEAD WAS CUT OR SNIPPED 27CM DISTAL OF PROXIMAL TERMINAL PIN, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS NO PORTION OF THE STIFFENER WIRE WAS RECEIVED AND CONFIRMS NO COIL WIRE FRACTURES.
PT ALLEGES RECEIVING IMPLANTS IN 5/82. PT ALSO ALLEGES "I FIRST STARTED WITH SEVERE CHEST PAINS, CHRONIC BLADDER PROBLEMS IN 1984. I HAD ATYPICAL RHEUMATIC DISEASE IN 1987 AND WAS HOSPITALIZED FOR 6 WEEKS ON RESPIRATOR. I SINCE HAVE BEEN DIAGNOSED WITH RAYNAUD'S DISEASE, ATYPICAL CONNECTIVE TISSUE, FIBROMYALGIA. I DON'T SLEEP, ALWAYS IN PAIN. I HAD A BAD MAMMOGRAM IN 1996 WHICH 3 DRS SAID WAS A TEAR IN IMPLANT AND SKIN PROBLEMS IN 1996." REFERENCE MEDWATCH #1009733.
PT ALLEGES SHE RECEIVED IMPLANTS IN 3/84. SHE ALLEGES IMPLANTS WERE REMOVED IN 7/96, BECAUSE ONE RUPTURED.
THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED PURSUANT TO 21 CFR, PART 803. THE REPORTS TRANSMITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OR OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAD FRACTURED AT WELD  SITE AND ~33MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES ~54MM AND HAS MIGRATED DOWN LEAD BODY ~40MM PROXIMAL OF WELD SITE. IT APPEARS THAT ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO ~87MM.
OR AXLE MAG W/NUT. DEALER CLAIMS THE QUICK RELEASE AXLE BALL BEARINGS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DENTENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIC DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE FRACTURED AT WELD SITE AND APPROX 320MM PROXIMAL OF WELD SITE. APPROX 6MM OF THE PROXIMAL END OF THE J STIFFENER WIRE WHICH FRACTURED AT WELD SITE WAS RECEIVED PROTRUDING OUT OF THE OUTER POLYURETHANE INSULATION APROX 37MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX 48MM AND HAS MIGRATED DOWN LEAD BODY APPROX 55 MM PROXIMAL OF WELD SITE. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATED THREE OF THE FOUR OUTER ANODE QUADRIFILAR COIL WIRE HAS FRACTURED APROX 1 MM PROXIMAL OF ANODE BAND. IT APPEARS THAT THE ENTIRE LENGTH OF THE J STIFFENER WIRE WAS RECEIVED WITH RECORDED MEASUREMENTS ADDING UP TO APPROX 88 MM. X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURES AND PROTRUSION.
PT ALLEGES RECEIVING IMPLANTS ON 12/20/72 AS REPLACEMENTS FOR ONES RECEIVED OF ANOTHER MFR. PT ALLEGES EXPERIENCING DISCOMFORT AND HARDENING BEGINNING 7/1/80 AND HAD REMOVAL AND REPLACEMENT ON 7/11/96 WITH DEVICES OF ANOTHER MFR. PHYSICIAN'S NOT STATES RUPTURE DETECTED RADIOLOGICALLY.
X-TUBE ASSM 18" X 16". DEALER CLAIMS THE X-BRACE IS BROKEN AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INF, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DR REPORTED OBSERVING A CORNEAL BURN WHILE PERFORMING A ROUTINE PHACOEMULSIFICATION PROCEDURE. THE DR PERFORMED A CLEAR CORNEAL 2.8 MM INCISION. THE PHACO TIP ON THE HANDPIECE WAS FROM A NON CO MFR.
AN EVALUATION WAS CONDUCTED ON THE UNIT AND THE RESULTS REVEAL THAT THE ASPIRATION AND VACUUM RATES WERE SLIGHTLY OUT OF THE SPECIFIED RANGE. ALL OTHER MEASUREMENTS WERE TESTED AND FOUND TO BE WITHIN THE SPECIFICATION. THE SLIGHT VARIATIONS IN THE ASPIRATION AND VACUUM RATES ARE NOT LIKELY TO HAVE CONTRIBUTED TO THE EVENT. THE HANDPIECE WAS ALSO EVALUATED AND IT WAS FOUND TO BE FUNCTIONING PROPERLY.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF HIGH THRESHOLDS.
PT ALLEGES RECEIVING IMPLANTS ON 3/2/77. PT ALLEGES CONSULTING HER PHYSICIAN IN 1980 BECAUSE OF FIRMNESS, HAS HAD CAPSULAR CONTRACTURE FOR QUITE A FEW YEARS AND FINDS IT ALMOST IMPOSSIBLE TO LIE ON HER STOMACH. PHYSICIAN'S NOTE STATES GEL IMPLANTS IN SITE SINCE 1977 AND FIRM.
QR AXLE W/NUT DEALER CLAIMS THE BALL BEARINGS FELL OUT OF AXIE.
X-TUBE ASSM 18" X 16" DEALER ALLEGES TUBE IS BROKEN AT THE CENTER BOLT.
BEFORE A DIALYSIS TREATMENT, THE AUTOTEST FAILED. THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE WAS REPLACED. THERE WAS NO PT INVOLVEMENT.
A MES (MEDICAL EQUIPMENT SVC) TECH EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC S/N MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC S/N MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF(ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 9/10/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED OL, INDICATING THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED  INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: N. SALES/SVC CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
PT ALLEGES RECEIVING IMPLANTS ON AN UNKNOWN DATE. PT ALLEGES HAVING HEALTH RELATED PROBLEMS SINCE RECEIVING IMPLANTS; HOWEVER, NO SPECIFIC RPOBLEMS WERE GIVEN.
BEFORE PTS CONNECT A FRESH BAG TO THEIR Y-SET, THEY NORMALLY FLUSH THE BAGS. THESE BAGS HAVE BEEN FOUND TO HAVE SMALL LEAKS, WHICH IF CONNECTED TO THE PTS WOULD RESULT IN INFECTION. SEVERAL PTS INVOLVED, DATE OF EVENT 8/3 - 9/17/96.
ENTERAL FEEDING PUMP SET WAS CONNECTED TO A PT'S HEPARIN LOCK. THE PEG PORT AND THE ENTERAL FEEDING PUMP SET HAD BEEN ADAPTED WITH AN IV INTERLOCK SYSTEM. THIS ADAPTATION PROVIDED A MORE SECURE CONNECTION BETWEEN THE PEG AND ENTERAL FEEDING PUMP SET. THIS ADAPTATION ENABLED THE ENTERAL FEEDING PUMP SET TO BE CONNECTED TO A PERIPHERAL IV. SECONDARY TO THE ENTERAL FEEDING BEING INFUSED VIA A PERIPHERAL IV, THE PT BECAME HYPOTENSIVE, DEVELOPED RESPIRATORY FAILURE, RENAL INSUFFICIENCY AND SEPSIS. THE PT RECOVERED FULLY FROM THE EVENT.
DURING PRIMING OF THE BLOOD TUBING SET, THE VENOUS LINE CAME OUT OF THE TOP OF THE DRIP CHAMBER. THERE WAS NO PT INVOLVMENT.
THE FACILITY DISCARDED THE BLOOD TUBING SET, THEREFORE, THE AFFECTED PRODUCT WAS UNAVAILABLE FOR INVESTIGATION. WITHOUT THE AFFECT PRODUCT FOR ANALYSIS, THE MFR IS UNAVAILABLE TO DETERMINE THE EXACT NATURE OF THE FAILURE. BASED ON THE REPORT DESCRIPTION, THIS MAY HAVE BEEN OBSTRUCTION OF THE SALINE LINE AT THE CONNECTION WITH THE CARTRIDGE OR THE MALE LUER, POSSIBLY CAUSED BY AN EXCESS OF SOLVENT COMBINED WITH A LACK OF AIR FLOW DURING THE ASSEMBLY DUE TO OPERATOR NOT FOLLOWING THE PROPER ASSEMBLY TECHNIQUE; OR CAUSED BY A MOLDING PROCESS PROBLEM WHICH BLOCKED THE MALE LUER LOCK OR THE CARTRIDGE PORT WHERE THE TUBING IS BONDED. HOWEVER, SINCE NO PRODUCT WAS AVAILABLE FOR INVESTIGATION, THIS REPORT REMAINS INCONCLUSIVE AS TO THE SOURCE OF THE REPORTED INCIDENT. A FAILURE INVESTIGATION WAS CONDUCTED BY THE MFR USING BLOOD TUBING SETS FROM THE SAME LOT NUMBER. FIFTEEN UNUSED SAMPLES WERE INSPECTED AND SALINE LINES TESTED FOR OCCLUSIONS USING AN AIR FLOW. NO FAILURES WERE FOUND. SAFETY ANALYSIS: THE PRIMARY PURPOSE OF THE SALINE LINE, LOCATED ON THE ARTERIAL DRIP CHAMBER OF THE CARTRIDGE, IS TO ALLOW ADMINISTRATION OF SALINE DURING THE DIALYSIS TREATMENT AND TO RETURN THE BLOOD TO THE PATIENT AT THE END OF THE DIALYSIS TREATMENT. AN OCCLUDED SALINE LINE SHOULD BE DETECTED DURING PRIME OR RECIRCULATION IF PROCEDURES RECOMMENDED IN THE OPERATOR'S MANUAL ARE PROPERLY FOLLOWED. THE OCCLUSION SHOULD BE FOUND WHEN THE OPERATOR INTENDS TO DELIVER SALINE TO RAISE OR ADJUST THE FLUID LEVEL IN THE ARTERIAL DRIP CHAMBER OR WHEN FRESH SALINE IS DELIVERED TO THE TUBING SET PRIOR TO THE START OF DIALYSIS. THE PATIENT IS NOT CONNECTED TO THE MACHINE AT THESE STEPS OF THE PROCEDURE, THEREFORE, THE RISK TO PATIENT SAFETY IS LOW. FOLLOW-UP ACTION: SINCE NO PRODUCT WAS RETURNED TO THE MFR FOR INVESTIGATION, IT IS DIFFICULT TO DETERMINE THE EXACT CAUSE OF THE REPORTED PROBLEM. HOWEVER, TESTED SAMPLES OF THE SAME LOT NUMBER FOUND NO FAILURES. THEREFORE, NO FURTHER REPORTING IS ANTICIPATED. THE MFR WILL CONTINUE TO MONITOR AND TREND. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD FOR THE SUSPECT LOT NUMBER INDICATED NO OTHER RELATED COMPLAINTS.
DEVICE APPEARED TO MALFUNCTION. UNABLE TO FIND BAND. CAVITY IRRIGATED. ABDOMEN X-RAYED. BAND EVENTUALLY FOUND IN THE TROCAR. APPLICATOR APPEARS TO STICK.
X-TUBE ASSM 17" X 16". DEALER ALLEGES X-TUBE IS BROKEN ON THE TOP LEFT.
PT ALLEGES RECEIVING IMPLANTS ON 7/31/87. PT ALLEGES SINCE IMPLANTED (I.E. JULY 31, 1987,) SHE HAS EXPERIENCED HARDENING. PHYSICIAN'S NOTE STATES "PT HAS CONSULTED WITH ME 4 TIMES OVER THE LAST 3 YEARS WITH ANXIETY REGARDING IMPLANTS, WORRIED THEY MAY RUPTURE AND HAVE PROBLEMS IN THE FUTURE."
OM 7/9/96 PUMP WAS TO BE INCREASED TO 6 MG/DAY WITH A BRIDGING DOSE OF 12.5 MG OVER 50 HRS. THE PUMP WAS MISTAKENLY PROGRAMED TO 6 MG/HR INSTEAD. ON 7/12/96 THE RATE WAS ORDERED TO INCREASE TO 8 MG/DAY AND WAS INCREASED TO 8 MG/HR IN ERROR.
MEDWATCH REPORT WAS RECEIVED BY ANOTHER COMPANY OFFICE. ATTEMPTS HAVE BEEN MADE TO OBTAIN DEVICE SPECIFIC INFO FROM THE REPORTER, THUS FAR WITHOUT SUCCESS. REPORTER APPARENTLY DID NOT KNOW PARTICULARS ABOUT DEVICE INVOLVED WITH PROGRAMMING OF THE DOSE.
CLIENT DEVELOPED ITCHING AND BUMPLIKE RASH AFTER USING THE LATEX GLOVES. SYMPTOMS LASTED FOR 2 TO 3 WEEKS. CLIENT HAS TRIED SEVERAL MEDICATIONS SUCH AS HYDROCORTISONE, BENADRYL AND ALCOHOL BUT STATED THEY WORSENED HER SYMPTOMS.
CASTER HINGE R RV. HINGE BOLTS ARE PULLING OUT.
THREAD ENGAGEMENT NOT SUFFICIENT. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT RECEIVED IMPLANTS ON AN UNKNOWN DATE. REPORT ALSO ALLEGES SHE HAS SUFFERED SEVERE EMOTIONAL DISTRESS, PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL DISABILITY AND SILICONE SYNDROME.
CONCLUSION: 68 OTHER(NO DEVICE RETURNED).
DURING PRIMING OF THE BLOOD TUBING SET, THE VENOUS LINE CAME OUT OF THE TOP OF THE DRIP CHAMBER. THERE WAS NO PT INVOLVEMENT.
PLEASE NOTE THAT CO IS UNABLE TO COMPLETE CO INVESTIGATION FOR THE INITIAL REPORT SUBMISSION. A FOLLOW UP REPORT WILL BE SUBMITTED BY 11/4/96.
CO IS UNABLE TO COMPLETE CO'S INVESTIGATION FOR THE INITIAL REPORT SUBMISSION. A FOLLOW UPREPORT WILL BE SUBMITTED BY DEC 4, 1996.
THE FACILITY DISCARDED THE BLOOD TUBING SET, THEREFORE, THE AFFECTED PRODUCT WAS UNAVAILABLE FOR INVESTIGATION. WITHOUT THE AFFECTED PRODUCT FOR ANALYSIS, THE MFR IS UNAVAILABLE TO DETERMINE THE EXACT NATURE OF THE FAILURE. BASED ON THE REPORT DESCRIPTION, THIS MAY HAVE BEEN AN ANCILLARY LINE THAT CAME OFF FROM THE TOP OF THE DRIP CHAMBER, DUE TO INSUFFICIENT SOLVENT APPLIED TO THE TUBING WHEN BONDED TO THE TOP OF THE DRIP CHAMBER; OR MAY HAVE BEEN A BROKEN LINE DUE TO AN EXCESS OF SOLVENT OR COULD HAVE BEEN A TUBING CUT BY A KNIFE USED FOR OPENING THE BOX CONTAINING THE PRODUCT. HOWEVER, SINCE NO PRODUCT WAS RETURNED FOR INVESTIGATION, THIS REPORT REMAINS INCONCLUSIVE AS TO THE SOURCE OF THE REPORTED INCIDENT. A FAILURE INVESTIGATION WAS CONDUCTED BY THE MFR USING BLOOD TUBING SETS FROM THE SAME LOT NUMBER. TWENTY UNUSED SAMPLES WERE INSPECTED, LEAK TESTED, AND SALINE LINES TESTED FOR OCCLUSIONS USING AIR FLOW. NO FAILURES WERE FOUND. SAFETY ANALYSIS: AN ANCILLARY LINE THAT COMES OFF THE DRIP CHAMBER SHOULD BE AS IN THIS CASE, DETECTED DURING PRIME, BECAUSE A SALINE LEAK WOULD OCCUR. IF THE LINE COMES OFF DURING DIALYSIS TREATMENT, ON THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WILL LIKELY CAUSE A MINOR BLOOD LEAK AND PRIMARILY AN AIR INFLUX SINCE ARTERIAL SIDE PULLS AIR INTO THE SYSTEM. THEREFORE, AIR WILL BE DETECTED, PUMP WILL STOP, ALERTING THE OPERATOR AND PROTECTING THE PATIENT. IF THE LINE IS ON THE POSITIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THE LIKELIHOOD OF INJURY IS LOW. FOLLOW-UP ACTION: THE BLOOD TUBING SETS ARE LEAK TESTED AS PART OF THE MFG PROCESS TO ASSURE THE INTEGRITY OF COMPONENTS AND BONDS. SINCE NO PRODUCT WAS RETURNED TO THE MFR FOR INVESTIGATION, IT IS DIFFICULT TO DETERMINE THE EXACT CAUSE OF THE REPORTED PROBLEM. HOWEVER, TESTED SAMPLES OF THE SAME LOT NUMBER FOUND NO FAILURES. THEREFORE, NO FURTHER REPORTING IS ANTICIPATED. THE MFR WILL CONTINUE TO MONITOR AND TREND. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD FOR THE SUSPECT LOT NUMBER INDICATED NO OTHER RELATED COMPLAINTS.
ON 4/13/96 RPTR WAS PREPARED FOR A CROWN. BEFORE VISIT WAS TOLD A SINGLE AREA IMPRESSION WOULD BE TAKEN. INSTEAD A SECOND IMPRESSION OF HALF THE MOUTH WAS DONE. WHEN ASSISTANT PUT IN THE MATERIAL IN THE MOUTH THEY SAID IT WOULD BURN AND IT HAD TO BE HELD FOR 5 MINS. THEY WERE BLOWING COOL AIR IN RPTR'S MOUTH AS RPTR CHOKED, FELT BURNING IN HER THROAT AND EYES TEARED FROM FUMES. AFTER REMOVAL GIVEN A GLASS OF WATER AND COULDN'T STOP COUGHING AS THROAT BURNED. RPTR GOT 8 BLISTERS ON THE SIDE OF THE TONGUE AND TONGUE WAS RAW LIKE A PIECE OF RAW MEAT. THROAT FELT DRY, BURNED AND SWOLLEN INSIDE. VOICE NOT THE SAME AND CONT'D TO GET HOARSE. WAS IN EXCRUCIATING PAIN AND COULD NOT EAT, DRINK, OR TALK. RPTR STILL IS GETTING HOARSE AND VOICE IS NOT THE SAME. SOMETHING IS WRONG, RPTR IS ALLERGIC TO IMPRESSION MATERIAL AND CEMENT USED FOR CROWN.
PT ALLEGES RECEIVING IMPLANTS ON 11/18/88. PT ALLEGES FOR THE LAST TWO YEARS (IE, 1994) HAVING PAIN AND SENSITIVITY, ESPECIALLY WHEN WEIGHT GAIN OCCURRED. PHYSICIAN'S NOTE STATES PT HAS CONCERN REGARDING THE LONG TERM SAFETY OF SILICONE GEL IMPLANTS.
PT WAS IMPLANTED WITH A SALINE PROSTHESIS ON 9/24/95. ON 8/22/96 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED A SEROMA IN HER RIGHT BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.                                                                          PRODUCT EVALUATION ATTACHED HERETO.
ADD'L INFO TO BE SUBMITTED?. Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY: MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION"
PT ALLEGES RECEIVING IMPLANTS ON 9/26/84. PT ALLEGES CONSULTING HER PHYSICIAN EARLY AFTER PROCEDURE DUE TO HARDENING. PHYSICIAN PERFORMED A CAPSULOTOMY. PHYSICIAN'S NOTE STATES FIBROUS ENCAPSULATION BILATERAL.
DURING PRIMING OF THE BLOOD TUBING SET, AN OCCLUDED SALINE LINE WAS FOUND. THE FACILITY WAS UNABLE TO INFUSE SALINE INTO THE SYSTEM. THERE WAS NO PT INVOLVEMENT.
THE FACILITY DISCARDED THE BLOOD TUBING SET, THEREFORE, THE AFFECTED PRODUCT WAS UNAVAILABLE FOR INVESTIGATION. WITHOUT THE AFFECT PRODUCT FOR ANALYSIS, THE MFR IS UNAVAILABLE TO DETERMINE THE EXACT NATURE OF THE FAILURE. BASED ON THE REPORT DESCRIPTION, THIS MAY HAVE BEEN AN OBSTRUCTION OF THE SALINE LINE AT THE CONNECTION WITH THE CARTRIDGE OR THE MALE LUER, POSSIBLY CAUSED BY AN EXCESS OF SOLVENT COMBINED WITH A LACK OF AIR FLOW DURING THE ASSEMBLY DUE TO OPERATOR NOT FOLLOWING THE PROPER ASSEMBLY TECHNIQUE; OR CAUSED BY A MOLDING PROCESS PROBLEM WHICH BLOCKED THE MALE LUER LOCK OR THE CARTRIDGE PORT WHERE THE TUBING IS BONDED. HOWEVER, SINCE NO PRODUCT WAS AVAILABLE FOR INVESTIGATION, THIS REPORT REMAINS INCONCLUSIVE AS TO THE SOURCE OF THE REPORTED INCIDENT. A FAILURE INVESTIGATION WAS CONDUCTED BY THE MFR USING BLOOD TUBING SETS FROM THE SAME LOT NUMBER. TWENTY UNUSED SAMPLES WERE INSPECTED, LEAK TESTED AND SALINE LINES TESTED FOR OCCLUSIONS USING AN AIR FLOW. NO FAILURES WERE FOUND. SAFETY ANALYSIS: THE PRIMARY PURPOSE OF THE SALINE LINE, LOCATED ON THE ARTERIAL DRIP CHAMBER OF THE CARTRIDGE, IS TO ALLOW ADMINISTRATION OF SALINE DURING THE DIALYSIS TREATMENT AND TO RETURN TO BLOOD TO THE PATIENT AT THE END OF THE DIALYSIS TREATMENT. AN OCCLUDED SALINE LINE SHOULD BE DETECTED DURING PRIME OR RECIRCULATION IF PROCEDURES RECOMMENDED IN THE OPERATOR'S MANUAL ARE PROPERLY FOLLOWED. THE OCCLUSION SHOULD BE FOUND WHEN THE OPERATOR INTENDS TO DELIVER SALINE TO RAISE OR ADJUST THE FLUID LEVEL IN THE ARTERIAL DRIP CHAMBER OR WHEN FRESH SALINE IS DELIVERED TO THE TUBING SET PRIOR TO THE START OF DIALYSIS. THE PATIENT IS NOT CONNECTED TO THE MACHINE AT THESE STEPS OF THE PROCEDURE, THEREFORE, THE RISK TO PATIENT SAFETY IS LOW. FOLLOW-UP ACTION: SINCE NO PRODUCT WAS RETURNED TO THE MFR FOR INVESTIGATION, IT IS DIFFICULT TO DETERMINE THE EXACT CAUSE OF THE REPORTED PROBLEM. HOWEVER, TESTED SAMPLES OF THE SAME LOT NUMBER FOUND NO FAILURES. THEREFORE, NO FURTHER REPORTING IS ANTICIPATED. THE MFR WILL CONTINUE TO MONITOR AND TREND. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD FOR THE SUSPECT LOT NUMBER INDICATED NO OTHER RELATED COMPLAINTS.
THE DEVICE WAS CONNECTED TO A PT'S HEPARIN LOCK. THE PEG PORT AND THE DEVICE HAD BEEN ADAPTED WITH AN IV INTERLOCK SYSTEM. THIS ADAPTATION PROVIDED A MORE SECURE CONNECTION BETWEEN THE PEJ AND THE DEVICE. THIS ADAPTATION ENABLED THE DEVICE TO BE CONNECTED TO A PERIPHERAL IV LINE. SECONDARY TO THE ENTERAL FEEDING BEING INFUSED VIA A PERIPHERAL IV LINE, THE PT BECAME HYPOTENSIVE, DEVELOPED RESPIRATORY FAILURE, RENAL INSUFFICIENCY AND SEPSIS. THE PT RECOVERED FULLY FROM THE EVENT.
MFR'S EVENT ID: RPIC 60254. CO'S STANDARD PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE REPORTER FOR COMPLETION. IN THIS CASE, THE REPORTER DID NOT PROVIDE THE REQUIRED INFO IN SECTIONS A4 AND B6. REFER TO USER REPORT #450068-1996-001. 9/9/96: RECEIVED A CALL FROM RISK MGR 9/9/96. SHE STATED THE NURSE IMPROPERLY PLACED THE TUBE. SHE PUT AN IV EXTENSION SET ON AN ENTERAL TUBING AND CONNECTED TO A LEVER LOCK CANNULA ON END OF PEG. PT RECEIVED FDG PRODUCT INTO IV LINE. PT HYPOTENSIVE, AND DEVELOPED ARDS IN ICU ON VENTILATOR. MEDWATCH FORM SENT TO ACCOUNT 9/9/96. 9/13/96-ALTHOUGH THE EVENT WAS CLEARLY CAUSED BY USER ERROR, IT IS REPORTABLE AS AN INJURY.
WHILE TRANSFERRING RESIDENT WITH LIFT FROM G/L TO BED RT STRAP RELEASED OR BROKE AWAY FROM LIFT PAD. RESIDENT STARTED TO SLIDE OUT OF LIFT PAD. TRIED TO BREAK FALL - RESIDENT LANDED ON RT SHOULDER. RESIDENT WAS UNCOMFORTABLE, COMPLAINING OF PAIN. RESIDENT SENT TO HOSP FOR X-RAY. RESIDENT RETURNED LATER ON 3-11 SHIFT.
PT ALLEGES RECEIVING IMPLANTS ON 8/19/83. PT ALLEGES CONSULTING HER PHYSICIAN IN THE "EARLY DAYS" BECAUSE OF HARDENING AND THEN AGAIN IN JUNE, 1996 BECAUSE OF RUPTURE AND PAIN. PT ALSO ALLEGES HAVING REMOVAL AND REPLACEMENT ON 7/30/96 WITH DEVICES OF ANOTHER MFR. PHYSICIAN'S NOTE STATES PT WAS CONCERNED IMPLANTS WERE RUPTURED AND ALTHOUGH NO MEDICAL PROBLEMS ATTRIBUTED TO SILICONE AND IMPLANTS, PT'S ANXIETY AND CONCERN WERE SIGNIFICANT AND ARE INDICATIONS FOR SURGERY.
THE PT WAS IMPLANTED WITH PROSTHESIS ON 2/15/96. ON 3/25/96 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION AND NOTED WOUND DEHISCENCE IN HER RIGHT BREAST AND REMOVED THE PROSTHESIS. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
ADD'L INFO TO BE SUBMITTED? Y. IS THE EVENT FREQUENCY ADDRESSES IN PRODUCT LABELING? N. IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSEDS IN PRODUCT LABELING? Y. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY.: MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 36OI (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO. "MENTOR H/S HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. MENTOR H/S DEFERS TO THE PT'S PHYSICIAN AND TO ANY CHARACTERISTICS REFERENCED IN THE PRODUCT EVALUATION ATTACHED HERETO."
IN THE PROCESS OF ATTACHING THE MONITOR LEADS TO THE PT, THE MONITOR PULLED FREE OF THE SUPPORT BRACKET ON THE MONITOR MOUNT STRIKING THE PT IN THE HEAD CAUSING A LACERATION.
510K # 950928. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL ? U. IS SVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IS SEVERITY GREATER FOR THIS EVENT? THAN IS USUAL? U.
PT ALLEGES RECEIVING BREAST IMPLANTS 1/15/84. PT ALLEGES SUFFERING FROM SYMPTOMS RESULTING FROM IMPLANTS, INCLUDING BURNING PAIN, AND HER DR SAID HER IMPLANTS ARE RUPTURED. PT ALSO BELIEVES HER IMPLANT IS RUPTURED BECAUSE EH LEFT SIDE OF HER BREAST HAS DECREASED IN SIZE.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF CONDUCTOR FACTURE.
ADDED: D6. CATALOG # 21-4506. SERIAL # NA. OTHER # NA. F10. PT CODE 2357. PT CODE 2091. B1. PRODUCT PROBLEM. THE USED PORTAL WAS RETURNED WITHOUT A CATHETER. UPON VISUAL EXAMINATION USING 10X TO 20X MICROSCOPY A SECTION OF CATHETER WAS FOUND OVER THE OUTLET BODY AND WITHIN THE LOCKRING. THERE WERE INDENTATIONS ON THE BODY OF THE PORTAL AND SCRATCHES AROUND THE LOCKRING. THE ORIENTATION AND PHYSICIAL CHARACTERISTICS OF THE INDENTATIONS AND SCRATCHES COMBINED WITH THE SECTION OF CATHETER TUBING IS CONSISTENT WITH AN INSTRUMENT HAVING BEEN USED TO OVER ENGAGE THE LOCKRING RESULTING IN A SHEARING OF THE CATHETER.
PT ALLEGES SHE RECEIVED BREAST IMPLANT(S) IN 2/88. SHE ALSO ALLEGES ENCAPSULATION.
FEMALE IN HER 20'S WAS ADMITTED FOR AN OB ULTRASOUND ON SUNDAY, 9/1. THE FOLEY WAS INSERTED AND WAS INFLATED WITH THE 10 CC PREFILLED WATER SYRINGE. WHEN THEY TRIED TO DEFLATE THE BALLOON, IT WOULDN'T. IT WAS REPORTED THE PT EXPERIENCED A GREAT DEAL OF DISCOMFORT WHEN THE FOLEY WAS REMOVED.
L/N IN STOCK AT THE HOSP ARE 800653, 800654, 899758. ACTUAL L/N USED IS UNKNOWN. REFERENCE MFR. COMPLAINT #K96-6-5-28. 510K=K810630. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FUTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF IT'S PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED. CO 81-SAMPLE HAS BEEN RETURNED AND EVALUATION IS IN PROGRESS.
PT RECEIVED IMPLANTS IN 1981 AND HAS POSSIBLE RUPTURE.
CAPSULECTOMY WITH REMOVAL OF LEFT INTACT IMPLANT - RIGHT RUPTURED IMPLANT.
DURING TESTING, "SM #9" FAILURE PROMPT WAS GIVEN.
THE REPORTED COMPLAINT WAS VERIFIED. A "SVC MANDATORY #9 TRANSISTOR VOLTAGE" MESSAGE THAT WILL NOT CLEAR AFTER 3 ON/OFF CYCLES AND REPLACEMENT OF BATTERY WITH A FULLY CHARGED BATTERY, IS A WARNING MESSAGE TO THE USER THAT THE DEVICE SHOULD NOT BE USED AND SVC OF THE DEVICE SHOULD BE REQUESTED. THIS IS NOTED ON PAGE 15 OF THE OPERATING INSTRUCTIONS FOR THE DEVICE. THE IGBT TRANSISTORS WERE TESTED AND FOUND TO BE OPERATING PROPERLY. THESE TRANSISTORS CONTROL THE DELIVERY OF THE SHOCK THROUGH THE TRANSFER RELAYS WHICH WERE FOUND TO BE THE PROBLEM AND WERE REPLACED. THE DEVICE WAS THEN THOROUGHLY TESTED TO ALL DEVICE SPECS AND WAS FOUND TO BE FULLY COMPLIANT THROUGH ALL TESTS COMPLETED.
PT ALLEGES RECEIVING IMPLANTS IN 1/72 AND SHE ALSO ALLEGES SHE JUST FOUND OUT HER RIGHT SIDE IS RUPTURED.
CAPSULECTOMY WITH REMOVAL OF 1 RUPTURED (RT) IMPLANT AND 1 INTACT (LEFT) IMPLANT.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE DR REPORTED THAT AN AUTOGENOUS BONE GRAFT BECAME INFECTED AND FAILED CAUSING THE LOSS OF THE IMPLANT. THIS IS THE SAME PT AS REPORTED IN MFR REPORT NUMBER 2029012199600008. DEVICE EXPIRATION DATE: 2000.
86=DIMENSIONAL ANALYSIS. 100=RETURNED COMPONENT MET CO VISUAL AND DIMENSIONAL SP[ECIFICATIONS IN ALL RESPECTS. H.3=DEVICE WAS EVALUATED BY DISTRIBUTOR. THE RESULTS OF THE EVALUATION WILL BE FORWARDED TO THE MFR.
PT ALLEGES RECEIVING IMPLANTS ON 7/13/76. PT ALLEGES MAMMOGRAM OF 10/19/93 SHOWS POSSIBLE RUPTURE. PT ALSO ALLEGES DR ADVISES REMOVAL. PHYSICIAN'S NOTE STATES IMPLANTS PRESENT SINCE 1976 WITH MAMMOGRAPHIC EVIDENCE OF POSSIBLE RUPTURE.
PT HAD BILATERAL SILICONE BREAST IMPLANTS REMOVED. IMPLANTS WERE RUPTURED.
PT ALLEGES RECEIVING IMPLANTS ON 1/20/81 AND HAD REMOVAL ON 5/7/95 DUE TO PAIN AND HARDNESS. PHYSICIAN'S NOTE STATES MARK ENCAPSULATION WITH PAIN AND TENDERNESS ON BOTH SIDES.
PHYSICIAN REPORTED REMOVING INFUSION SYSTEM DUE TO POSSIBLE MENINGITIS. PT RECEIVING MORPHINE PER PUMP. PUMP RETURNED AND ANALYZED.
THE PUMP MAY HAVE UNDERINFUSED. A PACLITAXEL SOLUTION WAS TO INFUSE OVER 24 HOURS AT 25 ML/HR. AFTER APPROX 30.5 HOURS AFTER THE START OF THE INFUSION, APPROX. 100 ML REMAINED IN THE SOLUTION CONTAINER. NO PT INJURY RESULTED. THE REPORTER COMMENTED THAT CAUSE OF THE REPORTED OCCURRENCE MAY HAVE BEEN FROM A LARGER VOLUME OF DILUENT BEING USED THAN INITIALLY THOUGHT.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY FLOW ACCURACY WAS PERFORMED FOR TWENTY FOUR HOURS AT 25 ML/HR. THE ACCURACY RESULTS WERE WITHIN SPEC.
SOLUTION SET COMPRESSED ON ITS OWN CAUSING THE REMOVAL OF THE PT'S IV.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE DR REPORTED THAT AN AUTOGENOUS BONE GRAFT BECAME INFECTED AND FAILED CAUSING THE LOSS OF THE IMPLANT. THIS IS THE SAME PT AS REPORTED IN MFR REPORT #968185100001.
H.6 86 =DIMENSIONAL ANALYSIS. 100=THE RETURNED COMPONENT MET INTERPORE VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
DURING INSERTION OF THE CERVICAL EPIDURAL CATHETER, A PORTION OF THE DISTAL END BROKE OFF. DISTAL END DISLODGED IN SUBCUTANEOUS TISSUE OF PT. BROKEN CATHETER RETRIEVED UNDER FLUOROSCOPY. A SMALL SKIN INCISION WAS MADE TO RETRIEVE DISTAL END. A SECOND CATHETER WAS INSERTED. PT RETURNED TO PACU POST PROCEDURE IN STABLE CONDITION.
WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER AFTER A C-SECTION, A PIECE OF THE OUTER COATING SEPARATED. THE PIECE OF CLOTHING WAS REMOVED FROM THE PT AND THERE WERE NO COMPLICATIONS. INFO FROM THE USER INDICATES THAT WHEN THE CATHETER WAS PLACED, THE PHYSICIAN GOT A WET TAP AND HE DECIDED TO GIVE A SPINAL DOSE RATHER THAN AN EPIDURAL DOSE. THE PHYSICIAN STATED THAT THERE WAS NOTHING WRONG WITH THE CATHETER. HE FEELS THAT THE PROBLEM WAS TECHNIQUE RELATED.
MFR CONTROL NO. DC96-545. THE SAMPLE WAS RETURNED FOR EVALUATION. CO'S EXAM FOUND THAT THE DISTAL MOST 6 CM OF THE CATHETER'S OUTER COATING HAD SEPARATED, BUT WAS NOT RETURNED. THE INNER CATHETER COIL HAD UNRAVELLED. IT APPEARS LIKELY THAT THE CATHETER WAS PINCHED DURING USE, CAUSING THE OUTER COATING TO SEPARATE DURING REMOVAL. THERE IS NO EVIDENCE OF ANY MATERIAL OR MFG DEFICIENCY.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT ADVANCE. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED NO PT INJURY.
THE PT, A NIDDM, PURCHASED A METER ON 7/22/96. SHE TESTED ON THE METER 3 TIMES BETWEEN 7/22 AND 8/27/96. ON 8/27, SHE "STARTED FEELING BAD" AND CONSULTED HER PHYSICIAN WHO RECOMMENDED SHE TEST HER BLOOD SUGAR MORE FREQUENTLY. SHE BEGAN TESTING 10 TIMES PER DAY. SHE REPORTED THAT THE READINGS OBTAINED ON THE METER(USING TEST STRIPS LOT #606680A, EXP. 6/98, OPENED 7/22) WERE IN THE 50'S AND 60'S (MG/DL). BASED UPON THESE READINGS, SHE "ATE MORE" AND STOPPED HER REGULAR INSULIN REGIMEN. SHE ALSO BEGAN TO EXPERIENCE THIRST AND FREQUENT URINATION. ON 8/30, NOT FEELING ANY BETTER, HER HUSBAND TRANSPORTED HER TO THE HOSPITAL. A CHEM 7 RESULT UPON ARRIVAL WAS 510, WITH A METER READING 30 MINUTES PRIOR BEING 65 MG/DL. SHE WAS TREATED WITH IV FOR DEHYDRATION AND INSULIN AND RELEASED THE SAME DAY. THE METER HAS NEVER BEEN CLEANED. THE METER WAS IN CALIBRATION ON 8/31, READING 74 VERSUS A RANGE OF 64-85. CONTROL SOLUTION TESTS WERE PERFORMED ON THE OPEN VIAL OF TEST STRIPS, AS WELL AS A NEW VIAL OF TEST STRIPS. THE RANGE ON BOTH VIALS IS 80-113. THE RESULT FOR THE VIAL IN USE AT THE TIME OF THE ALLEGED INCIDENT WAS 15, WHILE THE RESULT ON THE NEW VIAL WAS 101.
H6 RESULT:  NO NON-CONFORMANCES.  CO IS UNABLE TO COMPLETE THEIR INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE DUE TO THE FACT THAT THE METER WAS NOT RETRUNED TO LIFESCAN.  THEREFORE, CO HAS NOT BEEN ABLE TO EVALUATE THE METER TO DETERMINE WHETHER OR NOT A DEVICE MALFUNCTION MAY HAVE CONTRIBUTED TO THIS EVENT.  BATCH RECORD REVIEW INDICATES NO NON-CONFORMANCES IN THE MANUFACTURING PROCESS.  AT THIS POINT, CO CONSIDERS THIS MATTER CLOSED.  H6=BATCH RECORD REVIEW.
CHANNEL ONE OF THE PUMP OVERINFUSED. A 1529 ML SOLUTION OF MESNA WAS PROGRAMMED TO INFUSE OVER 24 HOURS AT A RATE OF 64 ML/HR. REPORTEDLY THE INFUSION COMPLETED 7 HOURS EARLIER THAN ANTICIPATED. NO PT INJURY RESULTED.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY FLOW ACCURACY TESTING WAS PERFORMED ON BOTH CHANNELS AT 125 ML/HR FOR ONE HOUR AND 10 ML/HR FOR TWO HOURS. IN ADDITION, TWENTY-FOUR HOUR ACCURACY TESTING WAS PREFORMED AT 64 ML/HR. ALL OF THE ACCURACY RESULTS WERE WITHIN SPEC.
DURING TONSILLECTOMY, PT RECEIVED THREE AREAS OF BURNS ON LOWER LIP. AN ELECTRO-CAUTERY EXTENSION ON THE HANDPIECE WAS OBSERVED TO HAVE A SPLIT IN THE INSULATION SHEATH.
AFTER THE CATHETER WAS INSERTED AND CONNECTED TO THE INTRA-AORTIC BALLOON PUMP, PUMPING WAS INTERMITTENTLY DISTURBED BY HELIUM LOSS ALARMS. FURTHER INVESTIGATION REVEALED THAT THE BUSHING AT THE CATHETER'S BIFURCATION HAD DETACHED. THERE WERE NO PT COMPLICATIONS.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. REP REPORTED THE SURGEON STATED ALTHOUGH HE HAD BOTH DISTAL AND PROXIMAL DONUTS COMPLETE, HE ENCOUNTERED AN INCOMPLETE ANASTOMOSIS. THERE WAS A TEAR NEAR THE ANASTOMOTIC SITE WHICH WAS OVERSEWN. A RESIDENT FIRED THE INSTRUMENT. IT IS UNKNOWN IF THE TEAR RESULTED FROM THE EITHER INSERTION OF THE INSTRUMENT OR DURING REMOVAL. THERE WAS NO CONSEQUENCE TO THE PT.
A2, B6, 7, D6, 10, F5-INFO NOT PROVIDED BY USER FACILITY F1: SHOULD NOT HAVE BEEN CHECKED ON INITIAL MEDWATCH. NO MEDWATCH WAS RECEIVED BY USER FACILITY. CONCLUSION: BASED ON THE INFO RECIEVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RELOADED AND FIRED. IT FIRED AND FORMED STAPLES AS DESIGNED AROUND THE ENTIRE STAPLE RING WITH A COMPLETE CUT ON THE TEST MEDIA. IT COULD NOT BE ASCERTAINED AS TO HOW THE TEAR MAY HAVE OCCURRED. THE BATCH BOOK WAS REVIEWED AND THERE WERE NO INCIDENCES OF MISSING STAPLES NOTED. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.ADDITIONAL DATA ENTERED IN D7, D8 AND D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN B4 AND F8. THE MFG REPORT # ON PAGE 1 OF INITIAL REPORT SUBMITTED WAS MISSING THE FIRST NUMERAL WHICH SHOULD HAVE BEEN (1). CORRECT MFG REPORT # IS 1219930-1996-00068. HOWEVER, THE MFG # ON PAGE 2 OF THE INITIAL REPORT, BOX G9, WAS CORRECTLY ENTERED AS 1219930-1996-00068.
THE INFUSION PUMP WAS REC'D IN SVC FACILITY WITH A VAGUE REPORT OF IT BEING PROGRAMMED TO DELIVER 500 ML AT 500 ML/HR AND THE SOLUTION NOT BEING DELIVERED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPEC.
PT GOT OUT OF BED TO USE THE BATHROOM. PT WAS FOUND LYING ON THE BATHROOM FLOOR. PT SUBSTAINED A 3 CM LACERATION TO LEFT BROW AND A 5 CM LACERATION ACROSS BRIDGE OF NOSE, REQUIRING A TRANSFER TO EMERGENCY FOR SUTURES AND X-RAYS.
THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS OR RELATIONSHIP TO THE PRODUCT. CO IS JUST RESPONDING TO THIS EVENT AS REQUIRED BY LAW. DEVICE IS BEING RETURNED TO CO FOR EVALUATION AND INVESTIGATION.
DURING AN UNSPECIFIED PROCEDURE INVOLVING ONE PT. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE PROCEDURE.
12/17/96 SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.  DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN B4, D7, D8, D9 AND F8. ADDITIONAL DATA ENTERED IN B5.
ON 4/28/94, THE PT UNDERWENT A TWO LEVEL DECOMPRESSION AND FUSION WITH INSTRUMENTATION AND PEDICLE SCREWS. X-RAYS INDICATED LOSS OF FIXATION OF ONE OF THE PEDICLE SCREWS AT L2 ON THE LEFT AND A BROKEN ROD AT L2-3 ON THE RIGHT. PT READMITTED ON 8/20/96 FOR ANTERIOR INTERBODY FUSION, L2-L3, WITH MOSS CAGE AND RIB GRAFT THROUGH LEFT T-12 THORACOTOMY.
ALLEGED INFECTION. FOLLOW-UP FINDINGS: AS PER HEALTH PROFESSIONAL INFECTION OF UNKNOWN ETIOLOGY.
THE POTENTIAL FOR THE ABOVE-NOTED EVENTS(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSES OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF CO'S EVALUATION OF THE DEVICE.  INFECTION.
DURING A KIDNEY TRANSPLANT INVOLVING ONE PT, THE STAPLE LINE DID NOT FORM PROPERLY. THE DEVICE WAS FIRED ON A CADAVER KIDNEY. THE STAPLE LINE LEAKED DURING TESTING OF THE ORGAN PRIOR TO TRANSPLANT.
IS FREQUENCY OR OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IF YES, THEN IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? NO. IS SEVERITY OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IF YES, THEN IS THE SEVERITY OF THIS EVENT GREATER THAN LABELED? NO. A REPORT OR OTHER INFO SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT NECESSARILY REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT OR BY FDA THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, OR THE REPORTING ENTITY OR ITS EMPLOYEES OR AGENTS, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE REPORTING ENTITY NEED NOT ADMIT AND MAY DENY (AND EXPRESSLY RESERVES THE RIGHT TO DENY) THAT THE DEVICE, THE PARTY SUBMITTING THE REPORT, OR EMPLOYEES THEREOF, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A TOTAL GASTRECTOMY PROCEDURE INVOLVING ONE PT, THE INSTRUMENT COULD NOT BE FIRED. THE SURGEON APPLIED ANOTHER INSTRUMETN TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
10/28/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA BY MFG. ADDITIONAL DATA ENTERED IN D1, D7, D8 AND D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN B4 AND F8.
HOSPITAL REPORTS DR HAS EXPERIENCED DIFFICULTIES WITH SURGICAL KNIFE. THE INCISIONS ARE LARGER WITH FLUID LEAKAGE. AN IRIS PROLAPSED AND REQUIRES SUTURES. FOLLOW-UP WITH PHYSICIAN CONFIRMS THIS REPORT. HE INDICATES THAT HE EXPERIENCED DIFFICULTIES ON ONE DAY WITH THE "NEW KNIFE. HE REPORTS WOUND LEAKAGE AND CHAMBER COLLAPSE. THE PROLAPSED IRIS WAS REPAIRED AND THE PT IS DOING WELL.
THIS IS THE EXTENT OF INFO WHICH WAS SUPPLIED BY THE SURGEON. THE KNIFE WAS DISCARDED SO NO SAMPLE WAS RETURNED. A REVIEW OF THE LOT NUMBER PROVIDED SHOWED NO CHANGES IN BLADE DESIGN HAD BEEN SHIPPED AT THE TIME OF THIS REPORT. THIS REPORT WAS MAILED IN TO FDA ON: 9/27/96. THE MFR'S INTERNAL REFERENCE NUMBER IS 0296-0357. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NO BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
A TOTAL OF 3 IMPLANTS WERE PLACED. DR DID NOT HAVE PT RECORDS, DATES, CAUSES, ETC. AVAILABLE. IMPLANT SITE #25, WAS REMOVED 2 1/2 WEEKS AFTER REPLACEMENT. DATE OF OCCURRENCE UNKNOWN. 1 IMPLANT IS STILL OK. ONE PERSON AFFECTED.
THE RETURNED IMPLANT WAS EVALUATED AND MEETS SPECIFICATIONS. THE REPORTED INFECTION IS THE PROBABLE CAUSE OF FAILURE.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE INVOLVING 1 PT, THE STAPLE LINE WAS INCOMPLETE. THE SURGEON COMPLETED THE PROCEDURE WITH SUTURE. THE HOSP HAS REPORTED NO PT INJURY.
SOURCE TELLS MFR THAT ARM CHAIR TIPPED OVER WITH PT STRAPPED IN IT. THIS RESULTED IN A HEAD INJURY. TREATMENT WAS ADMINISTERED IN HOSPITAL. PT HAS SUBSEQUENTLY RECOVERED FULLY.
DURING A LAPAROSCOPIC HERNIA PROCEDURE, INVOLVING ONE PT REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE AND DID NOT FORM STAPLES. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
FROSTBITE" DUE TO CONTINUOUS COLD THERAPY TO HAND AND FOREARM POST-OP PLATE AND SCREW REMOVAL AFTER BONE HEALED FROM TRAUMATIC FRACTURE APPROX 18 MOS PRIOR. RETURNED TO HOSP POST-OP DAY 5 WITH SWOLLEN ARM AND HAND WITHOUT CIRCULATION OR SENSATION. REQUIRED EMERGENT SURGERY TO RESTORE CIRCULATION. HAD PORTABLE CONTINUOUS COLD THERAPY UNIT ON HAND FOR 48 HRS - 72 HRS POST-OP - IN HOME SETTING. QUESTION ADEQUATE PRODUCT LABELING AND PRINTED INSTRUCTIONS FOR HOME USE.
DR REPORTS LENS CRACKING DURING FOLDING/INSERTION AND THE INCISION HAD TO BE WIDENED IN ORDER TO REMOVE THE LENS.
UPON EVALUATION OF THE LENS IT WAS FOUND TO HAVE A TORN HAPTIC. REPORTING FACILITY'S STATEMENT AND EVIDENCE ON LENS SURFACE REVEALED DAMAGE CAUSED BY CUSTOMER. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT. THE MFR'S INTERNAL REFERENCE NUMBER IS 96L4811. THIS REPORT WAS MAILED IN TO FDA ON:10/2/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE INFUSION PUMP WAS REC'D AT THE SVC FACILITY WITH A NOTE THAT STATED "PUMP CHANGING RATE BY ITSELF". NO ADD'L INFO REC'D. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY. THE INFUSION PUMP WAS RAN A RATES OF 125 ML/HR AND 10 ML/HR. NO SPONTANEOUS CHANGE IN THE INFUSION RATE WAS OBSERVED. THE FLOW ACCURACY RESULTS WERE WITHIN SPEC. THE INFUSION PUMP HAS MULTIPLE SAFEGUARDS TO PREVENT THE DEVICE FROM SPONTANEOUSLY CHANGING THE INFUSION RATE. THE MOST LIKELY CAUSE OF THE REPORTED OCCURRENCE WAS USER MISPROGRAMMING.
THE STOPCOCK CRACKED AND LEAKED DURING NG FEEDING.
ONE UNIT RETURNED TO CO FOR EVALUATION. EXAM OF THE RETURNED UNIT SHOWED THAT THE STOPCOCK PORT WAS SPLIT. DAMAGE APPEARS TO BE A CHEMICAL ATTACK. LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. CO OFFERS EQUIVALENT PRODUCT MADE OUT OF A CHEMICALLY RESISTANT MATERIAL WHICH IS DESIGNATED TO MEET THE DEMANDS OF EXPOSURE TO CHEMICALS AND PROVIDE THE CLINICIAN WITH ADDED SECURITY DURING ADMINISTRATION OF FLUIDS.
WEAR AND TEAR ON PATELLA AND INSERT. PATELLA DISASSOCIATED CAUSING LACK OF MOTION AND PAIN. REMOVED INSERT AND PATELLA AND REPLACED.
DR REPORTS WOUND WAS WIDENED AND POSTERIOR CAPSULE RUPTURED DURING POSITIONING OF THE IOL. "WHEN LENS WAS DIALED IN, CAUGHT ON VENT OR ANTERIOR CAPSULE". ATROPHY OF THE IRIS, SUPERIORLY, WAS NOTED AS WELL AS VITREOUS BULGE AND MINOR VITREOUS LOSS. AN ANTERIOR VITRECTOMY WAS PERFORMED. THERE WAS ALSO AN OBSERVATION OF INITIAL ACUTE CORNEAL DECOMPENSATION. DR REPORTS EVENT IS RESOLVING WITH VOLRAREN TREATMENT.
LENS EVALUATION REVEALED ONE BROKEN HAPTIC. LENS SURFACE WAS COVERED WITH DRIED CLINICAL, SOLUTION AND BLOOD. QUESTIONAIRE RETURNED FROM REPORTING FACILITY STATED "HAPTIC WAS NOT BROKEN". FOLLOW-UP QUESTIONAIRE MADE NO MENTION OF A BROKEN HAPTIC. THE MFR'S INTERNAL REFERENCE NUMBER IS 96L4278. THIS REPORT WAS MAILED IN TO FDA ON: 10/2/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE STOPCOCK CRACKED AND LEAKED DURING USE.
ONE UNIT RETURNED TO CO FOR EVALUATION. EXAM OF THE RETURNED UNIT SHOWED THAT THE STOPCOCK PORT WAS SPLIT. DAMAGE APPEARS TO BE A CHEMICAL ATTACK. LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. CO OFFERS AN EQUIVALENT PRODUCT MADE OUT OF A CHEMICALLY RESISTANT MATERIAL WHICH IS DESIGNED TO MEET THE DEMANDS OF EXPOSURE TO CHEMICALS AND PROVIDE THE CLINICIAN WITH ADDED SECURITY DURING ADMINISTRATION OF FLUIDS.
EXCESSIVE POLY WEAR. THE METAL BACKED PATELLA WAS REMOVED AND AN ALL POLY PATELLA WAS CEMENTED IN ITS PLACE.
THE DEVICE WAS IMPLANTED AND THE DEVICE CATHETER WERE LED SUBCUTANEOUSLY AND INSERTED IN THE BONE AND TISSUE AT THE INFECTED AREA FOR INFUSION OF AMIKACIN (NOTE: INFUSION OF AMIKACIN THROUGH THE BONE AND TISSUE IS NOT A MFR'S INDICATION FOR THE DEVICE'S INTENDED USE). ON 9/6/96, THE FACILITY'S PHARMD CONTACTED A MFR CLINICAL SPECIALIST. THE FACILITY'S PHARMD STATED THAT THE PT HAS BEEN RECEIVING AMIKACIN TREATMENT FOR MORE THAN FOURTEEN (14) WEEKS AND NOW REPORTS "DEAFNESS." THE PHARMD STATED THAT THE SERUM AMIKACIN LEVEL WAS NOT ROUTINELY MONITORED DURING THE PT'S THERAPY. THE FACILITY'S PHARMD STATED THAT SHE HAD A COPY OF THE APPLICATION GUIDELINES AND IS AWARE OF THE INFO PROVIDED CONCERNING MONITORING OF THE DRUG LEVEL. THE PHARMD PROVIDED THIS INFO TO THE PHYSICIAN WHO WAS DISTURBED AND CONCERNED ABOUT THE OCCURRENCE OF THIS SIDE EFFECT. THE MFR'S CLINICAL SPECIALIST REQUESTED SPECIFIC INFO ABOUT THIS SITUATION; HOWEVER, THE FACILITY'S PHARMD STATED THAT SHE AND THE PHYSICIAN DECLINE TO PROVIDE ADD'L INFO UNTIL AN AUDIOGRAM AND OTHER EVALUATION PARAMETERS ARE AVAILABLE. THEY WILL CONTACT THE MFR WITH INFO AT THAT TIME.
ON 9/27/96, THE MFR'S CLINICAL SPECIALIST CONTACTED THE FACILITY'S PHARMD FOR FOLLOW-UP INFO. THE FACILITY'S PHARMD STATED THAT SHE DID NOT CONTACT THE MFR WITH ADD'L INFO CONCERNING THIS SITUATION BECAUSE THE EAR, NOSE AND THROAT (ENT) PHYSICIAN WHO EXAMINED THE PT THOUGH THE HEARING LOSS IN THIS 82 YEAR OLD PERSON WAS NOT DUE TO THE AMIKACIN. HOWEVER, PHARMD ALSO STATED THAT THE PT WILL NOT BE RECEIVING FURTHER THERAPY WITH THE DEVICE AND THE DEVICE WILL BE EXPLANTED. THE FACILITY'S PHARMD REFERRED THE MFR'S CLINICAL SPECILIST TO THE IMPLANTING PHYISICIAN FOR ANY ADD'L INFO. THE FACILITY'S PHARMD INFORMED THE MFR'S CLINCIAL SPECIALIST THAT THE INSTITUTION WOULD BE WRITING PROTOCOLS CONCERNING THIS APPLICATION. THE MFR'S CLINICAL SPECIALIST QUESTIONED THE PHARMD IF SHE CLEARLY UNDERSTOOD THAT THE USE OF THE DEVICE FOR THIS APPLICATION WAS OFF-LABEL OR INVESTIGATIONAL. THE FACILITY'S PHARMD STATED THAT SHE DID HAVE QUESTIONS CONCERNING APPROVAL AND REQUESTED THE MFR'S CLINICAL SPECIALIST CLARIFY IF THE DEVICE WAS AN APPROVED DEVICE. THE MFR'S CLINICAL SPECIALIST STATED THE THE DEVICE IS APPROVED FOR A NUMBER OF APPLICATIONS, INCLUDING THE INTRAVENOUS ADMINISTRATION OF AMIKACIN. THE MFR'S CLINICAL SPECIALIST INFORMED THE FACILITY'S PHARMD THAT THE DELIVERY OF AMIKACIN BY THE DEVICE FOR LOCAL ANTIBIOTIC THERAPY, I.E., DIRECTLY TO THE BONE AND TISSUE SITE OF AN INFECTION IS NOT AN APPROVED APPLICATION OF THE DEVICE. THE FACILITY'S PHARMD STATED THAT THE FACILITY'S PHYSICIAN FOR INFECTIOUS DISEASES IS PLANNING TO WRITE AN ARTICLE CONCERNING THIS APPLICATION AND REQUESTED TO KNOW HOW TO CONTACT THE MFR'S CLINICAL SPECIALIST SHOULD HE HAVE ADD'L QUESTIONS. THE MFR'S CLINICAL SPECIALIST PROVIDED THE PHARMD WITH HER PAGER NUMBER, BUT RECOMMENDED THE PHYSICIAN CONTACT THE MFR'S DIRECTOR OF MEDICAL AFFAIRS. ON 9/30/96, A MFR REPRESENTATIVE ATTEMPTED TO CONTACT THE IMPLANTING PHYSICIAN; HOWEVER, BOTH HE AND HIS ASSISTANT WERE BUSY WITH PTS. ON 10/1/96, THE MFR'S REPRESENTATIVE ATTEMPTED TO CONTACT THE PHYSICIAN, HE WAS STILL UNAVAILABLE; HOWEVER, HIS MEDICAL ASSISTANT INFORMED THE MFR'S REPRESENTATIVE THAT THEY HAVE A FACILITY FULL OF OLDER PTS AND WITHOUT THE PT'S NAME THEY COULD NOT BE OF MUCH HELP PROVIDING FURTHER INFO; HOWEVER, NO MATTER WHO THE PT IS, THE ONLY REASON THE DEVICE WOULD BE EXPLANTED IS THAT THE MEDICATION IS NO LONGER NEEDED. SINCE NO FURTHER INFO CAN BE OBTAINED, E.G PT'S NAME, SERIAL NUMBER OF THE DEVICE, IMPLANT DATE, EXPLANT DATE OR RETURN OF THE DEVICE FOR ANALYSIS, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE PUMP WAS INVOLVED IN A OVERDELIVERY OF A CARDIZEM SOLUTION. THE PUMP WAS PROGRAMMED TO INFUSE AT 10 ML/HR TO DELIVER A 125 MG/125ML SOLUTION. TWO HOURS AFTER THE START OF THE INFUSION THE SOLUTION CONTAINER ONLY HAD A FEW MLS REMAINING. THERE WAS NO ILL EFFECT TO THE PT.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPEC.
HOSP TURNED PUMP ON PRIOR TO PUTTING IT ON A PT AND HAD SEVERAL SYSTEM ERROR ALARMS. THEY DID NOT USE THIS PUMP BUT BORROWED ONE FROM ANOTHER HOSP. THE SYSTEM ERRORS WERE 2 AND 4. NO PT COMPLICATIONS.
MFR CONTROL NO. DI96-184 THE CO FIELD SERVICE REPRESENTATIVE INVESTIGATED THIS INCIDENT ON 8/14/96. THE REPORTED PROBLEM COULD NOT BE DUPLICATED, HOWEVER THE CPU WAS REPLACED AND THE UNIT WAS TESTED THOROUGHLY. NO PROBLEMS WERE ENCOUNTERED.
SAMPLE HANDLER FAILED TO CONSISTENTLY PIPETTE POSITIVE CONTROL IN POSITONS 4 AND 5. INSUFFICIENT SAMPLE WHEN PIPETTING 50UL. PIPETTING OF 200 UL IS ACCEPTABLE. THE ASSAY BEING RUN AT TIME OF EVENT WAS AN HIV-1 P24 ANTIGEN ASSAY. A CO FIELD SVC ENGINEER WAS DISPATCHED TO SITE TO INVESTIGATE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
THE PRODUCT WAS APPLIED DURWING A FACE LIFT. REPORTEDLY, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
SAMPLE HANDLER FAILED TO CONSISTENTLY PIPETTE SAMPLE DILUENT IN RANDOM WELLS FOR HIV-1 P24 AND HCV ASSAYS. CO'S ELISA SOFTWARE WAS BEING USED. A FIELD SVC ENGINEER WAS DISPATCHED TO INVESTIGATE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN. THE HOSP HAS REPORTED THAT NO PT INJURY OCURRED.
PT RECEIVED HER SECOND TREATMENT ON 5/16/96, THE PT NOTED SWELLING AND REDNESS AT THE TREATMENT SITES. ON 6/1/96, THE PT NOTED SWELLING AT THE UPPER LIP; REACTINE WAS PRESCRIBED. ON 6/20/96, PREDNISONE WAS PRESCRIBED. ON 7/31/96, REDNESS PERSISTED, AND THE SWELLING HAD RESOLVED. THE PHYSICIAN BELIEVED THE SYMPTOMS REPRESENTED A HYPERSENSITIVITY.
VACUUM HUB ASSEMBLY'S CONNECTION BROKE OFF.
DURING A DIALYSIS TREATMENT, THE FACILITY REPORTED AN INCIDENT OF CLOTTING OF THE CIRCUIT. BLOOD LOSS WAS ESTIMATED AT 300CC. 300CC OF SALINE WAS ADMINSTERED AS REPLACEMENT VOLUME AND THE PT UNDERWENT AN UNSCHEDULED TREATMENT THE NEXT DAY.
THE MEDICAL EQUIPMENT SVC REP. FOUND A BROKEN BLOOD PUMP ROTOR SPRING AND REPLACED IT WITH A NEW ONE. THERE WERE NO PT INJURIES REPORTED. A REVIEW OF THE CPF HISTORY INDICATES THAT THERE WAS SECOND INCIDENT WITH THIS MACHINE BEFORE THE MACHINE WAS FIXED. THE OTHER INCIDENT IS ON CPF #0896202C3. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT THE SPRING BROKE IN FOUR PIECES. THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR # 960018. CUSTOMER CONTACTED: NO. SALES/SVC CONTACTED BY INVESTIGATOR ? NO. TRAINING REQUIRED ? NO.
DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, THE INSTRUMENT WOULD NOT OPEN. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
DENTAL ASSISTANT REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
METHOD (86): PART NOT AVAILABLE. LOT NUMBER NOT AVAILABLE FROM DR'S OFFICE.
THIS EVENT WAS REPORTED AS STENOSIS, INCOMPETENCE, CALCIFICATION AND HEMATOMA. NO FURTHER INFORMATION IS AVAILABLE.
DURING A DIALYSIS TREATMENT, THE FACILITY REPORTED AN INCIDENT OF CLOTTING OF THE CIRCUIT. BLOOD LOSS ESTIMATED AT 300CC. THE FACILITY ORIGINALLY BELIEVED THAT CLOTTING WAS DUE TO CATHETER PROBLEM AND THE CATHETER WAS REPLACED.
THE MES (MEDICAL EQUIPMENT SVC) TECHNICIAN FOUND A BROKEN BLOOD PUMP ROTOR SPRING AND REPLACED IT WITH A NEW ONE. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. A REVIEW OF THE CPF HISTORY INDICATES THAT THERE WAS SECOND INCIDENT WITH THIS MACHINE BEFORE THE MACHINE WAS FIXED. THE OTHER INCIDENT IS ON CPF #0896201C3. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT THE SPRING BROKE IN FOUR PIECES. THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE MFR'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/ OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960018.
DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE  INVOLVING ONE PT, THE INSTRUMENT WOULD NOT OPEN. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
METHOD (86): PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DR'S OFFICE.
PT CAME TO HOSP IN AMBULANCE FROM THE NURSING HOME ON 9/3/96. THE EXISTING TUBE WAS A COMPETITOR'S 14 FR GASTROSTOMY TUBE. THE STOMA WAS LEAKING AROUND THE G-TUBE. THE EXISTING TUBE WAS REMOVED, AND THE APPROPRIATE MEASURING DEVICE WAS USED TO DETERMINE THE SIZE OF THE TUBE TO BE PLACED. THE DEVICE (18 FR, SHORT) WAS PLACED. THE NURSE ASPIRATED FOR GASTRIC CONTENTS AND AUSCULTATED FOR PLACEMENT VERIFICATION. THE PT'S DAUGHTER RECEIVED INSTRUCTONS ABOUT THE DEVICE. THE PT WAS DISCHARGED BACK TO THE NURSING HOME. THE PT WAS READMITTED TO THE HOSP AT MIDNIGHT ON 9/4 (13 HOURS POST PLACEMENT). THE PT EXPIRED AT 1:00 AM.
MFR'S EVENT ID: RPIC 60241. CO'S STANDARD PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE REPORTER FOR COMPLETION. IN THIS CASE, THE REPORTER DID NOT PROVIDE THE INFO REQUIRED IN SECTION A4 OR D10.
THE LAB TECH, STATED THAT, AN ABUTMENT HE PREPPED IN THE TISSUE CUFF AREA BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO IS UNABLE TO REVIEW THE PRODCUT'S LOT HISTORY SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR'S OFFICE.
THE SERVICE REPORT SHOWS THAT WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE DEVICE, THE SERVICE TECHNICIAN VERIFIEE THE DEVICE AUDIBLE ALARM DID NOT SOUND. THE ST INSPECTED THE DEVICE AND ADJUSTED THE AUDIO ALARM CONTROLLER. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNWON WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
DURING LAPAROSCOPICALLY ASSISTED LOW ANTERIOR RESECTION PROCEDURE  INVOLVING ONE PT, THE INSTRUMENT WOULD NOT FIRE WITH 2ND DISPOSABLE LOADING UNIT. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
DURING A CATARACT EXTRACTION PROCEDURE, THIS OPHTHALMIC  MICROSURGICAL SYSTEM WOULD NOT BOOT UP. ANOTHER SYSTEM SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F OF THIS MEDWATCH WAS COMPLETED BY THE MFR. THE DATE USED IN SECTION F.13 IS THE DATE THE REPORT WAS REC'D BY THE MFR. VOLTS READ 4.8 FROM MAIN POWER SUPPLY. ALTHOUGH THE VOLTAGE WAS LOW (4.9 VOLTS IS MINIMUM). IT WAS HIGH ENOUGH TO POWER UP THE UNIT WHEN EVALUATED. THE VOLTS WERE ADJUSTED.
DURING A LOW ANTERIOR RESECTION PROCEDURE INVOLVING ONE PT, THE CENTER ROD DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED NO PT INJURY.
THE SERVICE REPORT SHOWS THAT WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE DEVICE THE SERVICE TECHNICIAN VERIFIED THE DEVICE DELIVERED VOLUME WAS OUT OF SPECIFICATION. ST INSPECTED THE DEVICE AND REPLACED THE PISTON CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GEATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
PRODUCT WAS IMPLANTED ON 3/8/95 AND REVISED ON 4/3/96 DUE TO PERITONEAL CATHETER FRACTURE DISTAL TO VALVE.
THE PRODUCT WAS RETURNED AND EVALUATED BY CO PS MEDICAL. THE EVALUATION INCLUDED A VISUAL EXAMINATION AND TESTING FOR TENSILE STRENGTH, ULTIMATE ELONGATION AND TUBING DIMENSIONS. THE PERITONEAL CATHETER WAS FRACTURED AT APPROX 3.5 CM DISTAL TO THE VALVE. THE FRACTURE APPEARED TO HAVE BEEN INITIATED BY ABRASION. THIS WAS EVIDENT FROM THE ABSENCE OF MATERIAL ON ONE SIDE OF THE CATHETER AS WELL AS THE ROUNDED EDGES AT THE FRACTURE SITE. THE PERITONEAL CATHETER APPEARED TO HAVE BEEN PARTIALLY WORN AWAY MOST PROBABLY DUE TO ABRASION. THIS PROBABLY LED TO THE REMAINDER OF THE CATHETER WALL TEARING, RESULTING IN THE BREAK. THE TUBING MET CO MEDICAL SPECIFICATIONS FOR DIMENSIONS, TENSILE STRENGTH AND ULTIMATE ELONGATION.
DURING SET UP BUT AFTER THE PT HAD BEEN PREPPED FOR A CATARACT EXTRACTION PROCEDURE, THIS OPHTALMIC MICROSURGICAL SYSTEM WOULD NOT CALIBRATE THE HANDPIECES TO BE USED. ANOTHER SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS REC'D. A CONNECTOR WAS NOT CONNECTED WHICH CAUSED THE REPORTED FAILURE.
THIS SERVICE REPORT SHOWS THAT WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE DEVICE THE SERVICE TECHNICIAN VERIFIED THE DEVICE DELIVERED VOLUME WAS OUT OF SPECIFICATION. THE ST INSPECTED THE DEVICE AND REPLACED THE PISTON CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO IS UNABLE TO REVIEW THE PRODUCT'S LOT HISTORY SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR'S OFFICE.
THE VENTILATOR ALARM SOUNDED ABNORMAL. THE CO CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND FOUND THAT THE ALARM NUT WAS TOO TIGHT, CAUSING A DISTORTION OF THE ALARM BODY. THE CSE ADJUSTED THE ALARM NUT. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED A A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
SAMPLE HANDLER FAILED TO ASPIRATE AND DISPENCE PROPERLY AND DID NOT GIVE THE APPROPRIATE ERROR MESSAGE. THIS OCCURRED ACROSS ALL ASSAYS. A CO FIELD SVC ENGINEER WAS DISPATCHED TO THE ACCOUNT AND THE INSTRUMENT WAS FOUND IN POOR CONDITION WITH DIRT AND SAMPLE RESIDUE ALL OVER. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
THERE IS AN INTERMITTENT PROBLEM WITH THE FOOTPEDAL USED WITH THIS OPHTHALMIC MICROSURGICAL SYSTEM. IT WILL NOT FUNCTION WHEN OPERATED SLOWLY, BUT WILL FUNCTION WHEN STEPPED ON HARD. THE PROBLEM INITIALLY HAPPENED ABOUT ONE MONTH AGO AND HAS RECURRED INTERMITTENTLY SINCE THEN.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS REC'D.
DURING A LAPAROSCOPIC COLON RESECTION PROCEDURE, THE JAWS WOULD NOT OPEN. THE SURGEON APPLIED ANOTHER DEVICE ACROSS THE PT SIDE WITH THE ORIGINAL DEVICE LOCKED ON THE TISSUE. HE REPAIRED THE OPERATION SITE WITH ANOTHER DEVICE.
10/14/96-SUPPLEMENTAL REPORT SUBMITTED TO FDA BY MFG. ADDITIONA INFORMATION DATA SUBMITTED FOR D-7, D-8, D-9 AND F-9. EVALUATION INDICATED AND CODES ENTERED ON H3 AND H6.
THE VENTILATOR WOULD AUTOCYCLE WHEN SENSITIVITY WAS SET TO 20. IT IS NOT VERIFIED THAT THE DEVICE/COMPONENT DID NOT FUNCTION TO SPECIFICATION, AND NO MALFUNCTION MAY HAVE OCCURRED. THE AUTO ZERO SOLENOID WAS REPLACED AS A PRECAUTION. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE/COMPONENT CAUSED OR CONTRIBUTED THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS  OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
DR REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS SAME PT AS PRIOR MDR REPORTS #M290722 AND M733367.
SAMPLE HANDLER FAILED TO ASPIRATE SAMPLE IN POSITONS AI, B5, B8, B11, B12, C6 AND C12 AND DID NOT GIVE AN ERROR MESSAGE DURING A HEAP;TITIS ASSAY. A CO FIELD SVC ENGINEER WAS DISPATCHED TO EVALUATE THE INSTUMENT. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
HANDPIECE EXHIBITED LOW PHACO POWER FROM 7/4 THROUGH 7/18. SEVERAL UNSUCCESSFUL ATTEMPTS TO RECALIBRATE THE HANDPIECE DURING SET UP RESULTED IN TOTAL SYSTEM FAILURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS REC'D. THE BLADE OF THIS DEVICE WAS FOUND TO BE CHIPPED. DAMAGE TO BLADE WAS CAUSED BY THE USER.
THE PATIENT EXPERIENCED SYNCOPE. THE REPORTER ALSO STATED THAT THE LEAD WIRE FRACTURED AND LEAD IMPEDANCE IS HIGH.  THE DEVICE WAS EXPLANTED.
THE FRACTURE OF THE OUTER COIL APPROXIMATELY 24CM FROM THE CONNECTOR PIN WAS THE RESULT OF SUBCLAVIAN STRESS.
SAMPLE HANDLER FAILED TO CONSISTENTLY PIPETTE POSITIVE CONTROL IN POSITIONS 4 AND 5. INSUFFICIENT SAMPLE WHEN PIPETTING 50UL. PIPETTING OF 200UL IS ACCEPTABLE. THE ASSAY BEING RUN AT TIME OF THE EVENT WAS AN HIV-1 P24 ANTIGEN. A CO FIELD SVC ENGINEER WAS DISPATCHED TO SITE TO INVESTIGATE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
DURNIG A CYSTECTOMY PROCEDURE, REPORTEDLY THE DEVICE JAMMED AND WAS DIFFICULT TO OPEN. THE SURGEON RESECTED THE DEVICE FROM THE TISSUE.
1/15/96- SUPPLEMENTAL REPORT #1 SENT TO FDA. CORRECTED DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. ADDITIONAL DATA ENTERED IN D7 AND D8.
CATHETER BROKE DURING REMOVAL ON 8/19/96. BABY BORN ON 8/11/96 AND CATHETER INSERTED IMMEDIATELY. BABY ALSO IMMEDIATELY TRANSFERRED TO ANOTHER FACILITY. CATHETER BROKE AT THE SECOND FACILITY. APPROX. 3/8 INCHES OF THE CATHETER WAS LEFT IN THE BABY. THE PIECE WAS RETRIVED BY THE NURSE WITH HER FINGERS. NO PT INTERVENTION OR COMPLICATIONS. NURSE MGR AT SECOND FACILITY STATED THAT UPON ARRIVAL FROM THE FIRST FACILITY, 6 INCHES OF THE UMBILICUS WAS STILL ATTACHED TO THE BABY. THE UMBILICUS WAS CAREFULLY CUT OFF WHILE THE CATHETER WAS STILL INDWELLING. IN HER OPINION, THE CATHETER MAY HAVE BEEN NICKED DURING THE CUTTING OF THE UMBILICUS WHICH OCCURRED SEVERAL DAYS PRIOR TO ITS REMOVAL.
SAMPLES FROM THE HOSPITAL'S STOCK (LOT NUMBER 527994, 526724, 450375 WERE DIMENSIONALLY EVALUATED AND PULL TESTED. THEY WERE FOUND TO MEET ALL MANUFACTURING SPECS. THE ACTUAL DEVICE (LOT NUMBER UNK) WAS EXAMINED AND FOUND TO BE NICKED ON THE SHAFT IN THE VICINITY OF THE BREAK. THE CUTS WERE APPROX 1/2 TO 1MM LONG AND ADJACENT TO THE FRACTURE SITE. NEONATAL NURSE MANAGER STATED, THE CATHETER DID NOT BREAK DUE TO A PRODUCT MALFUNCTION. SHE THINKS THE CATHETER WAS NICKED WHEN THE UMBILICUS WAS CUT. THE FOREGOING FITS THE FACTS AS REVEALED IN THE EXAMINATION OF THE ACTUAL SAMPLE.
SAMPLE HANDLER FAILED TO DETECT A CLOT IN THE SAMPLE IN POSITION A7 AND DID NOT GENERATE AN ERROR MESSAGE WHILE RUNNING A HEPATITIS CORE ASSAY. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
DURING A CATARACT EXTRACTION PRODUCERE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
A TOTAL OF 3 IMPLANTS WERE PLACED. IMPLANT SITE #27, WAS REMOVED 2 1/2 WEEKS AFTER PLACEMENT. DATE OF OCCURRENCE IS UNKNOWN. DR DID NOT HAVE ANY INFO. 1 IMPLANT I STILL OK. ONE PERSON AFFECTED.
DURING A LOW ANTERIOR RESECTION PROCEDURE, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON RESECTED TISSUE TO APPLY ANOTHER DEVICE. DATE DEVICE EXPIRES: 10/31/2000.
11/21/96- SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6. ADDITIONAL DATA ENTERED IN D7, D8 AND D9.
WHILE USING THE SAMPLE HANDLER DURING A HEPATITIS C ASSAY, THE BARCODE SCANNER ASSIGNED SEVERAL SAMPLE ID'S FROM ROW E TO ROW F WITHOUT GENERATING AN ERROR MESSAGE. A CO FIELD SVC ENGINEER WAS DISPATCHED TO VERIFY INSTRUMENT PERFORMANCE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
NO AUDIBLE ALARM ON ERROR OR ALARMS. EVALUATION SUMMARY: FAILURE DUE TO A DAMAGED SPRING HOLE IN THE LID ASSEMBLY PREVENTED CONTACT SPRINGS FROM MAKING CONTACT WITH THE TRANSDUCER.
PRODUCT WAS IMPLANTED ON 10/24/94 AND REVISED ON 3/23/96 DUE TO PERITONEAL CATHETER FRACTURE DISTAL TO VALVE.
THE PRODUCT WAS RETURNED AND EVALUATED BY CO . THE EVALUATION INVLUDED A VISUAL EXAMINATION AND TESTING FOR TENSILE STRENGTH, ULTIMATE ELONGATION AND TUBING DIMENSIONS. THE PERITONEAL CATHETER WAS FRACTURED AT APPROX 5 CM DISTAL TO THE VALVE. THE FRACTURE APPEARED TO HAVE BEEN INITIATED BY ABRASION. THIS WAS EVIDENT FROM THE ABSENCE OF MATERIAL ON EITHER SIDE OF THE FRACTURE SITE AS WELL AS THE ABRADED AND ROUNDED EDGES AT THE FRACTURE SITE. THE PERITONEAL CATHETER APPEARED TO HAVE BEEN PARTIALLY WORN AWAY MOST PROBABLY DUE TO ABRASION. THIS PROBABLY LED TO THE REMAINDER OF THE CATHETER WALL TEARING, RESULTING IN THE BREAK. THE TUBING MET CO'S SPECS FOR DIMENSIONS, TENSILE STRENGTH AND ULTIMATE ELONGATION.
ON 8/1/96, THE ACCOUNT OBTAINED ERRATIC DIGOXIN II RESULTS WHEN AN INITIAL SAMPLE RESULT WAS 0.0 NG/ML AND THE RERUN RESULT WAS 0.4 NG/ML, WHICH WAS REPORTED. THE RESULT WAS QUESTIONED AND THE PT'S BLOOD WAS REDRAWN. THE FIRST RESULT FOR THE SECOND SAMPLE WAS 0.0 NG/ML. WHEN RESPUN AND RUN IN A SAMPLE CUP, THE RESULT FOR THE SECOND SAMPLE WAS 1.4 NG/ML, WHICH WAS REPORTED. THE FOLLOWING DAY THE ACCOUNT RAN THE INITIAL SAMPLE AND OBTAINED A RESULT OF 1.5 NG/ML. NO REPORT OF INJURY.
INVESTIGATION SUMMARY: THE EVENT REP. IS NOT ADDRESSED IN THE DEVICE LABELING. A MALFUNCTION DID OCCUR. THIS REPORTABLE MDR EVENT WAS INVESTIGATED AS PART OF AN ONGOING STUDY OF THE AXSYM SYSTEM BY CO INTO THE CAUSATIVE REASON FOR MALFUNCTIONS. RESULTS OF THE INVESTIGATION YIELDED A NUMBER OF SYSTEM ENHANCEMENTS IMPLEMENTED ON CUSTOMER UNITS. IMPROVEMENTS INCLUDED AXSYM SYSTEM SOFTWARE VERSION 3.0 WITH ENHANCED ALGORITHM FOR FLUID DETECTION, NEW BUFFER TUBING AND SEAL FITTINGS WHICH REDUCED BUBBLES FORMING IN TUBING LINES, MODIFICATIONS TO THE LIQUID LEVEL SENSE BOARD TO DECREASE SENSITIVITY OF THE INSTRUMENT TO ELECTROSTATIC DISCHARGE, AND PACKAGING MODIFICATIONS FOR ADDED PROTECTION TO PROBES. IN ADDITION, CO HAS EMPHASIZED TO OUR CUSTOMERS THAT CORRECT OPERATING PROCEDURES MUST BE FOLLOWED TO ENSURE OPTIMAL PERFORMANCE OF THE AXSYM SYSTEM. AREAS THAT WERE EMPHASIZED INCLUDED PROBE CRASH RECOVERY PROCEDURE, RECOMMENDED TUBE SIZES AND TYPES, OPENING REAGENT BOTTLE 4, PROPER LOADING/UNLOADING OF REAGENT PACKS, AND ENSURING PROPER SAMPLE AND REAGENT HANDLING. THIS IS THE FINAL REPORT.
WHILE USING THE SAMPLE HANDLER THE BARCODE READER MISREAD A SAMPLE BARCODE LABEL AND DID NOT GENERATE AN ERROR MESSAGE. THE BARCODE LABEL WAS READ AS "041LJ30945" INSTEAD OF "041LH30916". THE ASSAY BEING RUN AT THE TIME WAS A HEPATITIS CORE ASSAY A CO FIELD ENGINEER WAS DISPATCHED TO THE ACCOUNT TO VERIFY INSTRUMENT PERFORMANCE. NO DIEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
DRIVE FAILURE NO ALARM. EVALUATION SUMMARY: FINAL ANALYSIS REVEALED THAT THE DRIVENUT BINDS DUE TO RUST AND CORROSION BUILD-UP PREVENTING PROPER FUNCTION. SERIAL # PRE-DATES DRIVENUT MATERIAL CHANGE.
PRODUCT WAS IMPLANTED ON 1/29/96 AND REVISED ON 8/4/96 DUE TO PERITONEAL CAHTETER FRACTURE DISTAL TO VALVE.
THE PRODUCT WAS RETURNED AND EVALUATED BY CO. THE EVALUATION INCLUDED A VISUAL EXAMINATION AND TESTING FOR TUBING DIMENSIONS. THE PERITONEAL CATHETER WAS FRACTURED AT APPROX 2 CM DISTAL TO THE VALVE. THERE WAS A SECOND PARTIAL FRACTURE LOCATED APPROX 1.5 CM DISTAL TO THE VALVE. THE REMAINDER OF THE PERITONEAL CATHETER WAS NOT RETURNED. BOTH FRACTURES APPEARED TO HAVE BEEN INITIATED BY ABRASION AS THE FRACTURE SITES WERE ABRADED AND ROUNDED. THE PERITONEAL CATHETER APPEARED TO HAVE BEEN PARTIALLY WORN AWAY MOST PROBABLY DUE TO ABRASION. THIS PROBABLY LED TO THE REMAINDER OF THE CATHETER WALL TEARING, RESULTING IN THE BREAK. THE TUBING MET CO'S SPECIFICATIONS FOR DIMENSIONS. TENSILE TESTING ON THE CATHETER SAMPLE WAS NOT POSSIBLE DUE TO THE INSUFFICIENT SIZE OF THE RETURNED SAMPLE.
DRIVE FAILURE NO ALARM. EVALUATION SUMMARY: FINAL ANALAYSIS REVEALED THAT THE DRIVENUT SLIDES FREELY DUE TO RUST AND CORROSION BUILD-UP PREVENTING PROPER FUNCTION. SERIAL# PRE-DATES DRIVENUT MATERIAL CHANGE.
INACCURATE DELIVERY. EVALUATION SUMMARY: FINAL ANALYSIS REVEALED THAT THE DRIVENUT SLIDES FREELY DUE TO RUST AND CORROSION BUILD-UP PREVENTING PROPER FUNCTION. SERIAL# PRE-DATES DRIVENUT MATERIAL CHANGE.
ALLEGED DEFLATION WITH SECONDARY INFECTION.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DIES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AND ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO HE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF CO'S EVALUATION OF THE DEVICE.
510K #950928. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL. U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
GIVING SET LEAKING AT POINT IDENTIFIED BY TAPE WHEN 5% DEXTROSE HAD BEEN RUN THROUGH. NO INJURY TO PT OR STAFF WAS NOTED.
REFERENCE METHOD OF EVALUATION-CODE 86, PRESSURE TESTED DEVICE TO VERIFY LEAKAGE REPORT.
ON 8/26/96, CO WAS INFORMED ON A DEATH CERTIFICATE THAT THE PT DIED OF A CARDIAC ARRHYTHMIA ON 6/23/95.
F10-1802 NOT LABELED. 2200 LABELED. 2204 NOT LABELED.
AUDIBLE ALARM ANOMALY. EVALUATION SUMMARY: FINAL ANALYSIS REVEALED THAT POPPED TRANSDUCER SPRINGS RESULTED IN LOSS OF AUDIBLE.
SAMPLE HANDLER HAD POSITIVE CONTROL SAMPLE DROPS ON THE ENDS OF TIPS WHEN DELIVERING 50UL OF SAMPLE TO WELLS DURING AN HIV-1 P24 ANTIGEN ASSAY. A SVC ENGINEER WAS DISPATCHED AND THE TIPS WERE FOUND TO BE SLIGHTLY BENT. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
DISCREPANT RESULTS REC'D WHEN RUNNING THE CK-MB ASSAY ON THE ANALYZER. THE ACCOUNT STATES CONTROLS HAVE BEEN DRIFTING LOW. A CK-MB RESULT OF 3.3 NG/ML WAS INITIALLY REPORTED FROM THE FIRST SAMPLE DRAWN ON A PT. THE SECOND SAMPLE DRAWN GAVE A RESULT OF 39 NG/ML. THE ACCOUNT THAN REPEATED THE FIRST SAMPLE WHICH GAVE RESULTS OF 39 NG/ML AND 42 NG/ML. NO MEDICAL INTERVENTION OCCURRED AS A RESULT OF THE LOW RESULT THAT WAS FIRST REPORTED. NO REPORT OF INJURY.
INVESTIGATION SUMMARY: THE EVENT REP. IS NOT ADDRESSED IN THE DEVICE LABELING. A MALFUNCTION DID OCCUR. THIS REPORTABLE MDR EVENT WAS INVESTIGATED AS PART OF AN ONGOING STUDY OF THE AXSYM SYSTEM BY  CO INTO THE CAUSATIVE REASON FOR MALFUNCTIONS. RESULTS OF THE INVESTIGATION YIELDED A NUMBER OF SYSTEM ENHANCEMENTS IMPLEMENTED ON CUSTOMER UNITS. IMPROVEMENTS INCLUDED AXSYM SYSTEM SOFTWARE VERSION 3.0 WITH ENHANCED ALGORITHM FOR FLUID DETECTION, NEW BUFFER TUBING LINES, MODIFICATIONS TO THE LIQUID LEVEL SENSE BOARD TO DECREASE SENSITIVITY OF THE INSTRUMENT TO ELECTROSTATIC DISCHARGE, AND PACKAGING MODIFICATIONS FOR ADDED PROTECTION TO PROBES. IN ADDITION, CO HAS EMPHASIZED TO CO CUSTOMERS THAT CORRECT OPERATING PROCEDURES MUST BE FOLLOWED TO ENSURE OPTIMAL PERFORMANCE OF THE AXSYM SYSTEM. AREAS THAT WERE EMPHASIZED INCLUDED PROBE CRASH RECOVERY PROCEDURE, RECOMMENDED TUBE SIZES AND TYPES, OPENING REAGENT BOTTLE 4, PROPER LOADING/UNLOADING OF REAGENT PACKS, AND ENSURING PROPER SAMPLE AND REAGENT HANDLING. THIS IS THE FINAL REPORT.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE HOOK TIP OF THE CANNULA BROKE OFF. BROKEN PIECE LEFT INSIDE THE PT.
A RETIRED PHYSICIAN AND LAWYER, WHO SERVES AS A MEDICAL AND LEGAL ADVISER, REPORTED TO THE INVENTOR OF THE LMA THAT HE HAD KNOWLEDGE OF THREE CASES IN WHICH THE PT'S ASOPHAGUS WAS RUPTURED DUE TO NEGLIGENT USE OF THE LMA. THIS INFO WAS THEN FORWARDED TO THE CO AND THE DISTRIBUTOR. UPON HEARING OF THIS REPORT, DISTRIBUTOR'S SAFETY OFFICER CONTACTED THE INITIAL REPORTER. THE REPORTER STATED THAT OF THE THREE CASES ONE PT HAD RECOVERED, ONE PT EXPERIENCED BRAIN DAMAGE (DEGREE UNK), AND ONE PT DIED. THE REPORTER STATED THAT DUE TO LEGAL CONSTRAINTS, HE BELIEVED HE EAS UNABLE TO REVEAL THE NAMES OF THE PTS, PRACTITIONER(S) OR HEALTH CARE FACILITY(S) INVOLVED, AND THE RECORDS CANNOT BE OPENED. THE REPORTER INDICATED THAT NEITYHER THE MFR, NOT THE DISTRIBUTOR, WAS CONTACTED AS THE EVENT WERE DUE TO GROSS MISUSE OF THE LMA BY THE HEALTH CARE PRACTITIONER(S) INVOLVED, AND WERE NOT CAUSED BY THE DEVICE. SINCE DIRECT INVESTIGATION OF THESE ALLEGED EVENTS IS NOT POSSIBLE, DISTRIBUTOR CONDUCTED A THOROUGH LITERATURE SEARCH (NERAC SERVICE; PARAMETERS: DEATH, BRAIN DAMAGE, ESOPHAGEAL RUPTURE) WHICH DID NOT REVEAL ANY SIMILAR CASES. THE MFR ALSO CONDUCTED A LITERATURE SEARCH IN A DATABASE WHICH INCLUDES ALL OF THE MAJOR EUROPEAN AND INTERNATION ANAESTHESIA JOURNALS USING ESOPHAGEAL RUPTURE AS A PARAMETER. AGAIN, NO SIMILAR CASES WERE FOUND. THE MFR CONCLUDES THAT IN LIGHT OF THE FACT THAT IT WAS NOT CONTACTED DURING ANY OF THE LEGAL PROCEDURES AND BASED UPON THE INFO PROVIDED BY THE REPORTER, THESE EVENTS RESULTED FROM HEALTH CARE PRACTIONER(S) ERROR AND MISUSE, AND DID NOT RRESUOLT FROM A DEVICE MALFUNCTION. AS IT IS NOT ANTICIPATED THAT FURTHER 8INFO WILL BE OBTAINED, THIS FILE IS CONSIDERED CLOSED.
THIS REPORT IS SUBMITTED ON BEHALF OF THE DEVICE MFR. THE INFO IN THIS REPORT IS BASED PRIMARILY ON INFO FROM THIRD PARTY SOURCES, THE ACCURACY OF WHICH HAS NOT BEEN CONFIRMED BY THE REPORTER. THE MFR REQUEST THAT IN ACCORDANCE WITH 21 CFR 803.9, FDA DELETE ANY INFO THAT CONSTITUTES TRADE SECRET OR CONFIDENTIAL COMMERCIAL OR FINANCIAL INFO UNDER 21 CFR 20.61 FROM THIS REPORT BEFORE RELEASE. PLEASE NOTE THAT THE MFR IS USING THE DISTRIBUTOR'S REPORTING NUMBER FOR IDENTIFICATION PURPOSES UNTIL A SEPARTE NUMBER IS ISSUED FOR THE MFR.
CATHETER WAS USED AS PRE-DILATATION BALLOON AT 6 ATMS. DEVICE WAS USED TO POST DILATE ANOTHER CO'S STENT, BALLOON BURST AT 14 ATMS.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED A 1.4 CM LONG, AXIALLY-DIRECTED TEAR, .6 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAMINATION: FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING AND ADJACENT TO THE TEAR EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE JAW OF THE FORCEPS BROKE OFF AND WAS NOT RETRIEVED.
THE ACCOUNT HAD A PT DIGOXIN SAMPLE WITH A RESULT OF >4.0 NG/ML. WHEN THIS SAMPLE WAS DILUTED 1:2, THE ACCOUNT REC'D A RESULT OF 3.1 NG/ML. THE CUSTOMER REPEATED THIS SAMPLE STRAIGHT AND REC'D A RESULT OF >4.0 NG/ML. THE CUSTOMER REPEATED THE 1:2 DILUTION AND REC'D A RESULT OF 2.5 NG/ML. THE 2.5 NG/ML RESULT WAS REPORTED OUT. ANOTHER TECHNOLOGIST AT THE ACCOUNT WAS RUNNING A DIGOXIN, THEOPHYLINE AND VANCOMYCIN FROM AN ALIQUOT SAMPLE AND REC'D A RESULT OF 2.8 NG/ML FOR DIGOXIN, WHICH WAS REPORTED TO THE FLOOR. THE TECHNOLOGIST REPEATED THIS RUN BECAUSE THE VANCOMYCIN WAS ACCIDENTALLY DELETED FROM THE FILE. THE DIGOXIN RESULT WAS 1.8 NG/ML. THE TECHNOLOGIST CALLED THE FLOOR TO CHANGE THE REPORT. NO MEDICAL INTERVENTION HAD TAKEN PLACE. THE PT WAS ADMITTED THROUGH ER WITH RESPIRATORY FAILURE. NO MEDICAL HISTORY IS AVAILABLE. NO REPORT OF INJURY.
THE INVESTIGATION FOR THIS REPORT IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL CONTAIN ADD'L INFO WITH A FINAL EVAL.
CUSTOMER CLAIMS UNDERCARRIAGE NOT EXTENDING COMPLETELY WHEN UNLOADING UNIT FROM AMBULANCE.
H-6 METHOD UNKNOWN-EVALUATED BY INDEPENDENT SVC AGENT. H-6 RESULTS- THE SVC AGENT EVAL: FOUR BOLTS IN THE UNDERCARRIAGE AND 2 LEG BOLTS WERE TOO TIGHT. BOLTS LOOSENED AND TREATED. STRETCHER RE-LUBED AND PUT BACK INTO SVC. H-6 CODE 68 CONCLUSION: UNABLE TO DETERMINE HOW/WHEN THE FASTENERS WERE OVERTIGHTENED.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION; THE BALLOON EXHIBITED AN AXIALLY-DIRECTED TEAR. MICROSCOPIC EXAMINATION: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY REVEALED EVIDENCE OF SEVERAL SURFACE ABRASION, PARALLEL AND ADJACENT TO THE TEAR. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
WHILE BODY IMAGES CAN FLIP FROM LEFT TO RIGHT.
CUSTOMER HAD BEEN USING THIS LOT NUMBER FOR PAST TWO WEEKS WITHOUT PROBLEM THEN REPORTED THREE LEAKS IN THREE DAYS. PHARMACY CONTACT CONFIRMED TWO SETS WERE LEAKING AT THE LUER TO TUBING CONNECTION, 1 SET WAS LEAKING AT THE LOWER END OF THE Y-SITE TO TUBING CONNECTION.
SENSE PACE LEAD ADAPTER WAS EXPLANTED IN 8/18/95, DUE TO NOISE. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORM TO SPEC.
PT WAS PREPARED FOR DIALYSIS AND AT THE ONSET OF DIALYSIS EXPERIENCED A REACTION, AND DIALYSIS WAS DISCONTINUED. TYPICAL SYMPTOMS OF REBOUND SYNDROME OCCURRED WITH A DROP IN BLOOD PRESSURE, DIZZINESS, AND PT LAPSED INTO A SEMI-CONSCIOUS STATE. BENADRYL WAS ADMINISTERED AND WITHIN 4-5 MINUTES, SYMPTOMS HAD SUBSIDED, BUT PT WAS ADMITTED INTO HOSP FOR OBSERVATION. NO FURTHER DEVELOPMENTS OCCURRED. IN DISCUSSING THE INCIDENT WITH THE CHIEF TECHNICIAN IT WAS BELIEVED THAT THE RINSING PROCEDURE WAS NOT FULLY FOLLOWED. CHIEF TECHNICIAN TESTED THE LOT TO DETERMINE ITS EFFICACY AND IT PROVED TO BE WITHIN SPECS. CO WILL TEST SEVERAL AMPULES FROM THE EFFECTED LOT AND SUBMIT THE RESULTS.
IMPROPER RINSING PROCEDURES PRIOR TO THE DEVICE USE CAUSED DISINFECTANT FORMALDEHYDE REBOUND.
SAFETY CLIP SLIT TUBING WHILE IN PUMP. NO ALARM, CONTINUED PUMPING INTO CENTRAL LINE. 100CC'S OF TPN SOAKED PT. NURSE NOTICED AND SAW PUMP WAS STILL PUMPING. THE IV SET WAS NOT SAVED.
CO HAS INFORMED REPORTER OF PROPER USE OF SAFETY CLIP.
AFTER PERFORMING A PROCEDEDURE USING THE FRAME, THE TIP OF A FIXATION SCREW WAS CHIPPED. THE HOSP COULD NOT DETERMINE IF THIS HAPPENED BEFORE, DURING, OR AFTER THE PROCEDURE. THE PT WILL UNDERGO MRI AT THE SIX WEEK CHECK UP TO CHECK FOR POSSIBLE DEBRIS.
PT UNDERGOING ANTERIOR CORPECTOMY AT C6 WITH STRUT GRAFTING AND PLATING. WHEN SURGICAL DRAPES WERE REMOVED FROM PT, AND THE ELECTRODE CONNECTIONS WERE REMOVED. BURNS WERE NOTED AT THE MOTOR RECORDING SITES AS WELL AS THE PT GROUNDING SITES FOR THE MOTOR EVOKED POTENTIAL. FOUR BURNS TOTAL AT THE LEFT AND RIGHT HIP (3RD DEGREE) AND ALSO AT THE LEFT AND RIGHT CALF.
THE TESTS ARE STILL BEING CONDUCTED AT THIS TIME. HOSP HAS BEEN CONTACTED FOR RETURN OF THE ACTUAL DEVICE. HOSP HAS NOT RESPONDED.
THE BALLOON CATHETER WOULD NOT ADVANCE OVER THE WIRE. ANOTHER BALLOON CATHETER ADVANCED OVER THE WIRE. ON THE INITIAL REPORT THE USER BELIEVED THE PROBLEM TO BE WITH THE BALLOON CATHETER. AFTER INVESTIGATIVE ANALYSIS OF THE BALLOON IT WAS DETERMINED THAT THE GUIDEWIRE HAD SEPARATED.
THE INFORMATION IN SECTION F WAS COMPLETED BY THE MFR. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFORMATION OF THE EVENT AND PATIENT STATUS FROM THE HOSPITAL, DISTRIBUTOR OR FIELD CONTACT AS APPROPRIATE.
ON 8/13/96 CO RECEIVED A SCREW FROM DR. DISCUSSION WITH DR REVEALED THAT AFTER PERFORMING A PROCEDURE USING THE FRAME, IT WAS NOTED THAT THE TIP OF A SCREW WAS CHIPPED. THE HOSP CAN NOT DETERMINE IF THIS HAPPENED BEFORE, DURING, OR AFTER THE PROCEDURE. THE PT WILL UNDERGO MRI AT THE SIX WEEK CHECK-UP TO CHECK FOR POSSIBLE DEBRIS.
CO WAS INFORMED ON AN EXPLANT REPORT THAT THERE WAS A SUSPECTED MALFUNCTION WITH THE SENSE PACE LEAD. THERE WAS NO INDICATIONS THAT THE ICD DID NOT PERFORM TO SPEC.
CUSTOMER ALLEGES BATTERY FAILED DURING A MEDICAL EMERGENCY ON BOARD A SHIP RESULTING IN PT DEATH. REPEATED ATTEMPTS BY MFR TO OBTAIN ADD'L EVENT AND PT DETAILS HAVE BEEN UNSUCCESSFUL. CUSTOMER STATES THIS DID NOT CAUSE OR CONTRIBUTE TO PT OUTCOME. MANUFACTURER'S RECORDS INDICATE BATTERY IN QUESTION WAS BEYOND RECOMMENDED USEFUL LIFE AS STATED IN DEVICE LABELING.
MFR HAS ATTEMPTED FIVE TIMES TO GET ADD'L INFO. NO ADD'L INFO HAS BEEN MADE AVAILABLE.
LEAD WAS REMOVED FROM SVC DUE TO "EXIT BLOCK AND HIGH THRESHOLDS." AN INVASIVE PROCEDURE WAS PERFORMED TO CAP THIS LEAD BECAUSE THE THRESHOLD MEASUREMENTS WERE GREATER THAN FOUR. THE LEAD WAS REPLACED. IMPLANTED ON 8/9/96. OUT OF SVC ON 8/21/96. IMPLANT DAYS ARE 12.
THE MFR HAS RECEIVED A REPORT OF A LEAFLET FRACTURE ATTRIBUTABLE TO USER ERROR RESULTING IN REOPERATION AND EXPLANT.
SECTION H6 - EVALUATION CODES. METHOD CODE 86 (OTHER) - A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED. RESULT CODE 100 (OTHER) - THE DEVICE HISTORY RECORDS REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS AT THE TIME OF MFR AND RELEASE. ALSO, THE FAILED LEAFLET COMPONENT HAD NO VISIBLE FLAWS.
VAGUE REPORT OF THE INFUSION PUMP BEING INVOLVED IN AN OVERINFUSION. NO SPECIFIC CLINICAL INFO WAS REPORTED. NO PT INJURY OCCURRED. THE REPORTER STATED THAT THE PUMP WAS EVALUATED BY THE HOSP BIOMED. DEPT. AND THE REPORTED ISSUE COULD NOT BE REPLICATED.
AN ABUTMENT BROKE IN FUNCITON. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN  MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISOTRY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DOCTOR'S OFFICE.
A TOTAL OF 3 IMPLANTS WERE PLACED 4/18/96. PT IS A NON-SMOKER WITH HIGH BLOOD PRESSURE. PT EXPERIENCED PAIN, TIGHTNESS AND TENDERNESS PRIOR TO REMOVAL. ONE PERSON AFFECTED.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. INFECTION IS THE PROBABLE CAUSE OF FAILURE.
A TOTAL OF 3 IMPLANTS WERE PLACED. THIS IMPLANT REMOVED 9/5/96. PT IS A NON-SMOKER WITH HIGH BLOOD PRESSURE. PT EXPERIENCED PAIN, TIGHTNESS AND TENDERNESS PRIOR TO REMOVAL. ONE PT AFFECTED.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. THE PT'S LIKELY INFECTION IS THE PROBABLE CAUSE OF FAILURE.
IMPLANT DID NOT INTEGRATE. ONE PERSON AFFECTED.
THE REPORTED INFECTION IS THE LIKELY CAUSE OF FAILURE.
THE PT MEDICAL HISTORY WAS RECEIVED 10/21/96. THE INFO INDICATES THAT THE PROBABLE CAUSE OF IMPLANT FAILURE IS THE REPORTED INFECTION, COMPOUNDED BY THE PT'S SMOKING.
WHILE GIVING A BATH THE STRETCHER RELEASED AND THE PT FELL TO THE FLOOR. PT RECEIVED A HEMATOMA TO THE HEAD.
UPON INSPECTION THE DEVICE WAS FOUND TO BE IN GOOD WORKING CONDITION. CAP NUT WAS MISSING ALLOWING THE BOLT WHICH HOLDS STRETCHER TO COME LOSE AND PT TO FALL. CAUSE OF INCIDENT WAS DUE TO MAINTENANCE ERROR. MAINTENANCE MANUAL SPECIFICALLY STATES THAT ALL BOLT AND NUTS MUST BE CHECKED PERIODICALLY TO INSURE PROPER OPERATION AND SAFE USE OF DEVICE. CAP NUT HAS BEEN REPLACED. CUSTOMER HAS BEEN INSTRUCTED TO REVIEW THE MAINTENANCE MANUAL FOR PROPER MAINTENANCE OF THE DEVICE. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. WILL ADD'L INFO BE PROVIDED AFTER 15-DAY REPORT? N. THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT INDEPENDENT VERIFICATION AS TO ITS ACCURACY. COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21 CFR 600, 803, 1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
A LARGE SLING (BLUE CODE) WAS BEING USED TO LIFT A PT WHEN THE BLACK PLASTIC CLIP SHEARED FROM THE SLING FABRIC. THE PT FELL TO THE FLOOR BUT HAS NOT SUFFERED SERIOUS INJURY AS THE FALL WAS CUSHIONED BY THE BED. THE SLING AND BROKEN CLIP IS NOW HELD AT HOSP.
FOREIGN REPORTER IS TO FORWARD ALL INFO TO THIS OFFICE RELATING TO INCIDENT, AS WELL AS A CLOSING OUT REPORT. INITIAL 15 DAY REPORT. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. WILL ADD'L INFO PROVIDED AFTER 15-DAY REPORT? N. THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT     INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21 CFR 600, 903, 1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
THIS LEAD AND ANOTHER LEAD WERE DISLODGED. AN INVASIVE PROCEDURE WAS PERFORMED TO REPOSITION THE LEADS.
CNA WAS LIFTING RESIDENT FROM TUB WHEN RESIDENT FELL TO FLOOR STRIKING HEAD AND FACE ON FLOOR. RESIDENT SUFFERED A LACERATION TO FACE BUT X-RAYS SHOWED NO FRACTURES.
IT WAS STATED THAT THE LIFT LOST PRESSURE AND DROPPED SUDDENLY. UPON INSPECTION TO THE LIFT IT WAS FOUND TO BE IN PROPER WORKING ORDER, AND IT WAS ALSO DISCOVERED THAT ONLY ONE BELT WAS BEING USED. THIS STRAP WAS IN NEED OF REPLACEMENT, STRAP WAS REPLACED WITH TWO STRAPS, THE CORRECT NUMBER OF STRAPS TO BE USED. INCIDENT CAUSE WAS USER ERROR IN NOT USING CORRECT STRAPS. CUSTOMER HAS BEEN INSTRUCTED TO REFER TO THE OPERATIONAL MANUAL FOR PROPER INSTRUCTON ON USE OF DEVICE. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. WILL ADD'L INFO PROVIDED AFTER 15-DAY REPORT? N. THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21 CFR 600, 803, 1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
WHILE PERFORMING A SOFT SARCOMA PROCEDURE ON THE LEFT THIGH, IT WAS NOTED THAT THE PROBE'S FREEZE CONTROL VALVE DID NOT SHUT OFF COMPLETELY. IN ORDER TO DISCONTINUE FREEZING OF THE PROBE, THE LIQUID NITROGEN IN THE DEWAR WAS VENTED. THERE WERE NO PT COMPLICATIONS.
AN OLD STYLE EJECTOR WAS RECEIVED AS A REPAIR. THE FOOTPLATE WAS BROKEN OFF, AND DISCUSSION WITH HOSP PERSONNEL REVEALED THAT THIS INCIDENT OCCURRED WHILE THE INSTRUMENT WAS BEING USED ON A PT. THE BROKEN PART WAS RETRIEVED, AND THE SURGERY COMPLETED WITHOUT FURTHER INCIDENT.
IMPLANT WAS PLACED IN PT ON 4/10/95 AND WAS REMOVED ON 2/15/96. IMPLANT WAS PLACED IN TOOTH POSITION #18, MIDLINE MANDIBLE.
IMPLANT UP TO SPECS. NOT ATTRIBUTED TO PRODUCT.
IMPLANT WAS PLACED IN PT ON 12/11/95 AND REMOVED ON 4/29/96. IMPLANT WAS PLACED IN TOOTH POSITION #22, IN MANDIBLE.
SURGEON ATTEMPTED REMOVAL OF 2X4MM RIGHT KIDNEY STONE USING WIRE STONE BASKET. NO PROBLEM WITH INTRODUCTION. WIRES OF STONE BASKET (WITH STONE INSIDE) BECAME LODGED IN URETERAL MUCOSA. SURGEON UNABLE TO REMOVE THE DEVICE. RETURN TO SURGERY NECESSARY ON 8/22/96 FOR CYSTOTOMY, URETEROTOMY WITH A) URETERONECYSTOTOMY AND B) URETEROLITHOTOMY. SURGEON'S OP NOTE STATES THE MAIN REASON THE STONE WAS NOT ABLE TO BE REMOVED WAS THE FACT THAT THE STONE HAD TRANSVERSELY CROSSED THE LOWER SEGMENT AND WAS UNABLE TO BE EXTRACTED. STONE TOO LARGE FOR THE URETER TO ALLOW TO PASS BECAUSE OF ITS FLEXIBILITY.
RAISED PT TO BATHE IN TUB, AT TOP OF ELEVATION, LIFT STARTED TO TIP OVER. ATTENDANT TRIED TO BREAK FALL OF PT. AS LIFT WAS FALLING THE PT'S LEG AND STOMACH STRUCK A HALF WALL IN THE ROOM. THE ATTENDANT NEEDED HELP TO UNBUCKLE PT FROM CHAIR. PT RECEIVED BRUISED TO ABDOMEN AND RIGHT LEG.
CAUSE OF EVENT IS IMPROPER MAINTENANCE. THE INSPECTION REVEALED THE LIFT TO BE IN PROPER WORKING CONDITION WITH THE EXCEPTION THE ANCHOR BOLTS WERE LOOSE. IT IS STATED IN THE MAINTENANCE MANUAL THESE BOLTS ARE TO BE CHECKED FOR TIGHTNESS EVER QUARTER. THE CUSTOMER HAD FAILED TO DO SO. THE CUSTOMER HAS BEEN INSTRUCTED TO REVIEW THE MAINTENANCE MANUAL. THE BOLTS HAVE BEEN RETIGHTEN BACK TO THEIR PROPER TIGHTNESS. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. WILL ADD'L INFO PROVIDED AFTER 15-DAY REPORT? N. THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21 CFR 600, 803, 1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
PT USING OXYGEN CONSERVING DEVICE WITH OXYGEN CYLINDER. UPON GETTING OUT OF THE CAR, HEARD A LOUD LEAKING NOISE, THEN SAW SOME SOME, AND FLAMES COMING FROM BAG.
ACCORDING TO THE FIRE DEPT PERSONNEL, WHEN THEY ARRIVED ON SCENE THE UNIT WAS LAYING ON THE GROUND SMOKING BUT THE FIRE WAS OUT. THE DELAY INDICATOR LED WAS ON AND THE UNIT WAS ALARMING. WHEN THEY TRIED TO TURN OFF THE UNIT, THE RED LED WOULD NOT GO OFF. THE UNIT WAS THEN TURNED OVER TO FIRE INVESTIGATION. ON 9/4/96, PERSON FROM CO MET WITH HOMECARE AGENCY AND SEVERAL FIRE DEPT REPS AND LOOKED AT THE UNIT AS IT WAS FOUND AT THE SCENE.THE BAG WAS DESTROYED, BUT THERE WAS A SMALL SECTION MELTED FAST TO THE TANK. THE STRAP WAS ALSO MELTED OFF, ALTHOUGH THE SHOULDER PAD WAS STILL MOSTLY INTACT. THE TUBING FROM THE UNIT TO THE CANNULA WAS IN SEVERAL PIECES, THE CANNULA NASAL END WAS INTACT AND THE CONNECTOR WAS STILL ATTACHED TO THE UNIT. THE LENS IN THE CONTENTS GAUGE OF THE REGULATOR WAS MELTED. THE PULSE DOSE SWITCH WAS IN THE "ON" POSITION, THE CONTINUOUS FLOW TOGGLE VALVE WAS IN THE "OFF" POSITION AND THE FLOW SELECTOR WAS SET AT "2 LPM". THE CANNULA FITTING ON THE UNIT WAS UNDAMAGED AND ALL THE LABELING ON THE FRONT OF THE UNIT WAS INTACT. THE LOWER PART OF THE FRONT CASE WAS MELTED. THE REAR CASE WAS DESTROYED. WHEN THE REGULATOR WAS REMOVED FROM THE TANK, THE T-HANDLE WAS NOT TIGHT. THE CASE ON THE UNIT WAS OPENED WITH SOME DIFFICULTY DUE TO THE CONDITION OF THE REAR CASE. THE TUBING GOING TO THE PRESSURE SENSOR WAS MELTED OFF AS WELL AS THE TUBING GOING TO AND FROM THE CONTINUOUS FLOW TOGGLE VALVE. WHILE THERE WAS HEAT AND SMOKE DAMAGE TO THE FRONT OF THE BOARD, THERE WAS NO INDICATION THAT THE IGNITION SOURCE WAS ON THE CIRCUIT BOARD. THEY REMOVED THE REGULATOR AND TESTED IT FOR PROPER OPERATION. IT STILL MAINTAINED PRESSURE FLOW. THEY ALSO TESTED THE SOLENOID FROM THE UNIT TO MAKE SURE IT WAS OPERATING CORRECTLY. IT ALSO PASSED THE TESTING WITH NO PROBLEMS. AT THIS TIME, CO SUSPECTS THE LOOSE T-HANDLE AND AN IGNITION SOURCE EXTERNAL TO THE UNIT AS THE CAUSE OF THIS INCIDENT AND HAVE NO REASON TO BELIEVE THE UNIT MALFUNCTIONED. THIS CONCLUSION IS ALSO BASED ON THE FACT THAT THERE ARE NO SPARK PRODUCING ELEMENTS ON THE BOARDS WHICH ARE ALSO SEALED (CONFORMALLY COATED) OTHER THAN THE ON/OFF SWITCH.
THE IAB WAS IN USE ON A PT IN THE OPERATING ROM. APPROX EIGHT HOURS AFTER INSERTION A BALLOON RUPTURE WAS NOTED. THE IAB WAS REMOVED AND EXCHANGED WITHOUT ANY COMPLICATIONS.
UNIT DID NOT FUNCTION PROPERLY. BOTH THE CAUTERY AND THE VITRECTOMY MODES DID NOT WORK AFTER MY FIRST PHACO PROCEDURE. IN ADDITION, DESPITE SHOWING A 100% POWER ON THE SCREEN, IN MY OPINION THE REAL POWER OF ALL THE PHACO HANDPIECES USED (IN TOTAL 4) SEEMED TO BE MUCH LESS. UNDER THESE CONDITIONS I CARRIED OUT SIX PROCEDURES. ON THE NEXT DAY 4 OF 6 PTS HAD MARKED CORNEAL EDEMA, LEADING TO CORNEAL DECOMPENSATION, WHICH PERSISTED OVER TIME NECESSITATING NOW (2.5 MONTHS AFTER) CORNEAL TRANSPLANTATION. THE PROCEDURES WERE OTHERWISE UNEVENTFUL.
THE UNIT FUNCTIONED AS PER THE DEFINED REQUIREMENTS. NO PROBLEM COULD BE FOUND. THE HANDPIECES USED WITH THE UNIT COULD NOT BE TESTED AND THE PHYSICIAN DID NOT KNOW WHICH HANDPIECES HAD BEEN USED DURING THE PROCEDURES. NOTE: SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. REFERENCE MFR REPORTS 1920664-1996-00503, 1920664-1996-00504 AND 1920664-1996-00505. ADD'L INFO RECEIVED ON 9/18/96 INDICATED THAT THERE WERE A TOTAL OF FOUR PTS INVOLVED.
A1,4;B6,7;D10: INFORMATION UNAVAILABLE: REP REQUESTS CALL AFTER DR. SPEAKS TO SURGEON. TKB. 9/6/96 1300 SPOKE WITH GENERAL COUNCIL, LEGAL SERVICES. SHE STATED SHE WOULD LIKE IN WRITING CO REQUEST FOR ANY PATIENT INFORMATION. BAH. 9-16-96 DR. TRIED TO CONTACT THE SURGEON. SENT NO CONTACT LETTER. CRB. D5,6;H4,6: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE SALES REP CALLED A FEW MINUTES AFTER THE HEAD NURSE CALLED TO REPORT THE EVENT. HE HAD NOT YET REACHED THE SURGEON AND WILL CALL BACK WITH FURTHER INFORMATION. THE PATIENT WAS A 72 YEAR OLD MALE.
RESIDENT WAS BEING TRANSFERRED, HE BECAME AGITATED AND BUMPED HIS HEAD ON THE END OF THE BAR WHERE RESIDENT IS TO PLACE HANDS. RESIDENT RECEIVED A LACERATION OF 1/4" TO FOREHEAD.
UPON INSPECTION THE LIFT WAS FOUND TO BE IN PROPER WORKING CONDITION. THE RUBBER END PIECES ON THE END OF THE BARS HAVE BEEN REMOVED BY THE FACILITY. THIS LEFT THE EXPOSED END ON WHICH THE RESIDENT HAD INJURIED HIMSELF. CAUSE OF EVENT IS MAINTENANCE ERROR DUE TO THE FACT THAT THE RUBBER ENDS WERE NOT IN PLACE. CUSTOMER HAS BEEN INSTRUCTED TO REVIEW THE MAINTENANCE MANUAL FOR THE DEVICE, FOR THE COMPLETE UNDERSTANDING OF MAINTAINING THE DEVICE CORRECTLY. THE RUBBER ENDS ALSO HAVE BEEN REPLACED ON THE DEVICE. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. WILL ADD'L INFO PROVIDED AFTER 15-DAY REPORT? N. THIS REPORT IS BASED ON INFO SUPPLIED TO WITHOUT     INDEPENDENT VERIFICATIONS AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21 CFR 600, 803, 1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
DURING HELICAL SCANNING THE SYSTEM MALFUNCTIONED AND MOST OF THE SCAN DATA WAS LOST. PROBLEM HAS BEEN TRACED TO A PROBLEM IN THE SOFTWARE WHICH HAS BEEN CORRECTED IN FORWARD PRODUCTION AND WILL BE RELEASED TO THE FIELD WITHIN THE 4TH QUARTER OF 1996.
THE SET WAS BLOCKED DURING USE. PT WAS DEHYDRATED. D15 AND HYPERAL WAS ADMINISTERED.
THE CUSTOMER RETURNED FOUR SAMPLES TO CO FOR EVALUATION. EXAMINATION OF THE RETURNED UNITS WAS UNABLE TO CONFIRM THIS ISSUE. THE UNITS WERE ATTACHED TO PUMPS AND INFUSED ACCORDINGLY. NO PARTICULATE MATTER COULD BE SEEN IN THE SETS. LOT HISTORY REVIEW WAS NOT AVAILABLE AS THE LOT NUMBER WAS UNKNOWN TO THE CUSTOMER. CO WAS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME.
THE CUSTOMER REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH TEST STRIPS, LOT # 1 K506B. HE OPENED THE BOTTLE OF TEST STRIPS APPROX 3 WEEKS AGO AND OBTAINED READINGS IN THE 90-110 MG/DL RANGE. HE DID NOT QUESTION THE READINGS BECAUSE THEY WERE "GOOD RESULTS". HE OBTAINED READINGS IN THIS RANGE FOR APPROX ONE WEEK. BECAUSE HIS READINGS USUALLY FLUCUATE MORE AND OFTEN EXCEED 110 MG/DL, HE BEGAN TO QUESTION THE RESULTS. HE TOOK HIS METER AND TEST STRIPS TO HIS DOCTOR'S OFFICE AND PERFORMED A SIDE COMPARISON WITH ANOTHER BRAND TEST STRIPS AND THE DOCTOR'S METER (ANOTHER MFR'S, TYPE UNKNOWN). THE RESULT WITH ANOTHER TEST STRIPS ON THE DOCTOR'S METER WAS 191 MG/DL AND THE RESULT WITH CO TEST STRIPS ON THE CUSTOMER'S WAS 110 MG/DL. THE CUSTOMER DOES NOT HAVE ANY NORMAL CONTROL SOLUTION TO THE TEST STRIPS FOR ACCURACY. HE CANNOT LOCATE HIS CHECK STRIP TO TEST THE METER. THE CODE WAS SET CORRECTLY FOR ALL TESTS. THE DESICCANT IS IN THE BOTTLE OF ONE TEST STRIP.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 8/28/96. ONE OPENED BOTTLE, CONTAINING 24 STRIPS WITH DESICCANT WAS RETURNED TO CO FOR EVAL. THE TEST RESULT OF THE RETURNED BOTTLE CONFIRMED THE COMPLAINT OF LOW BLOOD GLUCOSE READING. FURTHER EVAL OF DESICCANT INSIDE THE RETURNED BOTTLE INDICATES THE FAILURE OF TEST STRIPS MAY BE DUE TO EXPOSURE TO MOISTURE. SOURCE OF THE EXPOSURE IS UNKNOWN. ERROR GRID ANALYSIS INDICATES THAT CUSTOMER'S TEST STRIPS MAY PRODUCE RESULTS WHICH FALL IN ZONE B, AND DO NOT REPRESENT A REASONABLE RISK OF SERIOUS INJURY. PLEASE NOTE THAT CUSTOMER DID NOT RUN COMPARISON WITH AN ACCEPTABLE REFERENCE METHOD. PRODUCT SHOULD NOT BE COMPARED TO OTHER TEST STRIPS WHICH THEMSELVES MAY BE INACCURATE. ALL THE RETENTION SAMPLE TEST RESULTS CONTINUE TO PROVIDE ACCEPTABLE PERFORMANCE INDICATING NO TREND OF PRODUCT DEGRADATION. TREND ANALYSIS OF COMPLAINT SHOWS THIS IS THE FIRST COMPLAINT FOR LOT 1K506B. BASED ON THE PRESENT EVAL, THE RISK OF FURTHER PRODUCT FAILURES IN THE FIELD IS LOW. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING?. NO. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
THE 512H WAS USED DURING A LAPAROSCOPIC PROCEDURE. THE SURGEON WAS INSERTING TROCAR INTO PT WHO HAD PREVIOUS SURGERY AND KNEW WOULD HAVE ADHESIONS. AFTER SEVERAL ATTEMPTS, SURGEON WAS HAVING TROUBLE ENTERING PERITONEAL CAVITY. THE ADHESIONS WERE SO DENSE, SHE COULD NOT TELL WHERE SHE WAS. SHE FINALLY CUT DOWN AND REALIZED SHE HAD ENTERED INTO THE COLON. SHE IS NOT SURE IF SHE PUNCTURED IT WITH THE TROCAR OR IF BY PUSHING AND TWISTING THE TROCAR AND THAT TORE THE BOWEL. THE SURGEON HAD TO OPEN AND REPAIR THE BOWEL. THE PT IS DOING FINE.
A1,2,3,4,B6,7,D10-INFO NOT PROVIDED BY USER FACILITY. H4,8,D5,6-INFO NOT AVAILABLE. RECORD PURPOSES ONLY: NO ANALYSIS COULD BE PERFORMED SINCE NO INSTRUMENT WAS RECEIVED. THE INFO YOU HAVE PROVIDED HAS BEEN NOTED AND SHARED WITH THE APPRORIATE MFG PERSONNEL.
THE CATHETER WAS IN USE FOR SEVERAL HOURS IN A LABOR AND DELIVERY PT. THE NURSE FELT SOME RESISTANCE DURING REMOVAL OF THE CATHETER. THE PT WAS REPOSITIONED AND THE CATHETER WAS PULLED AGAIN. AT THIS POINT IT SEPARATED. THE REPORTER ESTIMATES THAT ABOUT 5" OF THE OUTER COATING IS MISSING. NO DECISION HAS BEEN REACHED REGARDING THE REMOVAL OF THE PIECE OF COATING.
PT UNDERWENT SPINAL FUSION PROCEDURE ON 11/5/92. ON 8/1/94, PT UNDERWENT ADD'L PROCEDURE AND PARTIAL REMOVAL OF INSTRUMENTATION. SOLID FUSION WAS FOUND AT L2-L4. SCREW FRACTURED AT S1. THE DR STATED "THE NEED FOR REPEAT SURGERY IS ENTIRELY BASED ON HER PAIN BECAUSE OF THE FAILURE OF THE FUSION."
DURING HELICAL SCANNING THE SYSTEM MALFUNCTIONED AND MOST OF THE SCAN DATA WAS LOST. PT HAD TO BE RESCANNED. PROBLEM HAS BEEN TRACED TO A PROBLEM IN THE SOFEWARE WHICH HAS BEEN CORRECTED IN FORWARD PRODUCTION AND WILL BE RELEASED TO THE FIELD WITHIN THE 4TH QUARTER OF 1996.
PT UNDERGOING EPS WITH PROCEDURE START APPROX. 0820. PT WAS RESTLESS AND C/O DISCOMFORT DUE TO BACK PAIN. MEDICATION GIVEN FOR RELIEF, HOWEVER PT CONTINUED WITH INTERMITTENT DISCOMFORT PULLING AGAINST WRIST AND LEG RESTRAINTS. APPROX. 6 HRS INTO PROCEDURE, BP 50/45 HR; FLUID GIVEN AND NARCAN. BP TO 76/44; ECHO CONFIRMED TAMPONADE. DEVICE APPARENTLY PERFORATED PERICARDIUM. PT CODED, BAGGED, PERICARDIOCENTESIS, INTUBATED. RESUSCITATION WAS SUCCESSFUL AND PT TRANSFERRED TO ICU. THE PT WAS COMATOSE WITH DETERIORATING CONDITION. BRAIN DEATH ESTABLISHED BY ECG, ORGAN DONATION OF LUNGS AND BODY RELEASED TO MEDICAL EXAMINER.
THE MFR WAS INFORMED BY THE ELECTROPHYSIOLOGY LAB PERSONNEL AT HOSPITAL THAT THEY ARE NOT CLAIMING THAT THE MFR'S DEVICES CAUSED THE INCIDENT.
A TECHNOLOGIST TOOK A SCOUT IMAGE THAT NEVER APPEARED. THE SCOUT IMAGE HAD BEEN SUSPENDED AND COULD NOT BE IMAGED. THE SYSTEM WAS REBOOTED AND THE SYSTEM THEN SCANNED PROPERLY. THERE WAS A DELAY IN TREATMENT OF APPROX 15 MINS.
RESIDENT WAS FOUND, EXPIRED, WEDGED BETWEEN THE BEDRAIL AND MATTRESS OF HER BED AT 8:55 AM AFTER HAVING BEEN PROVIDED INITIAL MORNING CARE AT 6:55 AM. PT HAD HX OF ALZHEIMER'S AND DIMENTIA AND WAS RESTRAINED WITH A VEST RESTRAINT AT THE TIME OF THE INCIDENT.
A BLADDER NECK SUSPENSION PROCEDURE WAS PERFORMED WITHOUT INCIDENT ON AN EXTREMELY OBESE PT. THE PT RETURNED WITH AN ABSCESS AT THE RIGHT INCISION SITE. AN X-RAY REVEALED THE LEFT ANCHOR HAD BECOME UNSEATED AND WAS FREE-FLOATING. THE SUTURE WAS REMOVED. HOWEVER, THE ANCHOR WAS LEFT IN THE PT. THE PT WAS PLACED ON ANTIBIOTICS FOR TWO WEEKS. NO FURTHER TREATMENT WAS REQUIRED AND THE PT'S CONDITION IS GOOD. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. WOUND INFECTIONS ARE AN ANTICIPATED COMPLICATION OF ANY SURGICAL PROCEDURE. OBESITY MAY INCREASE THE POTENTIAL FOR THIS COMPLICATION. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT.
F10-2446-NOT LABELED, 1690-NOT LABELED, 1179-LABELED, 1526-LABELED.
PT WAS FOUND IN A POOL OF BLOOD. A T CONNECTOR HAD PULLED LOOSE FROM THE IV LINE. THE PT LOST APPROXIMATELY 20 CC OF BLOOD. THE PT HEART RATE WAS 210 AND HEMATOCRIT WAS GREATER THAN 40. 30 CC OF NORMAL SALINE WAS PUSHED IN 10 MINUTES. THE HEART RATE DECREASED TO 160 AND THE HEMOCRIT RETURNED TO 34.7.
CHAIR USER ALLEGES THAT ATTENDANT "PUT HER IN CHAIR AND STARTED UP THE STAIRS. THEY WERE AT ABOUT THE THIRD STEP, THE BACK RIGHT SIDE OF THE CHAIR BROKE. CHAIR SWERVED AND THEY FELL DOWN STEPS.
BREAKAGE IS DUE TO IMPROPER USE OF CHAIR, LIFTING THE CHAIR AND END USER UP STEPS.
A GUIDEWIRE USED FOR FILTER PLACEMENT BECAME IN THE FILTER TIP FOLLOWING DEPLOYMENT VIA A JUGULAR APPROACH. THE WIRE WAS STRETCHED TO THE JUGULAR VEIN WHERE IT WAS CUT. A PORTION OF THE WIRE REMINS AFFIXED TO THE FILTER. THIS DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. CO'S ATTEMPTS TO GAIN FURTHER INFO HAVE BEEN UNSUCCESSFUL. SHOULD INFO BECOME, AVAILABLE, IT WILL BE FORWARDED ON A SUPPLEMENTAL MEDWATCH FORM REFERENCING THE APPROPRIATE SEQUENCE NUMBER.
F 10. #1236-LABELED, #1526-LABELED, #1528- NOT LABELED.
THE T CONNECTOR DISCONNECTED FROM THE IV LINE RESULTING IN THE LOSS OF BLOOD. PT REQUIRED INFUSION OF SALINE.
CUSTOMER INDICATED SAMPLES WOULD BE RETURNED TO CO FOR EVALUATION. SAMPLES HAVE NOT YET BEEN RECEIVED. LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OR RETURNED PRODUCT EVALUATION. ADD'L REPORT WILL BE PROVIDED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF CO'S EVALUATION.
IN AN EVALUATION BY CO, PROPER DEVICE OPERATION WAS OBSERVED. AN EVALUATION OF THE DEVICE MEMORY MODULE OBSERVED THE DEVICE FUNCTIONED AS DESIGNED. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
DEVICE DID NOT APPROPRIATELY ADVISE SHOCK FOR A SHOCKABLE PT ECG.
A JUGULAR FILTER WAS INADVERTENTLY PLACED VIA A FEMORAL APPROACH. THE FILTER WAS SUCCESSFULLY SNARED AND REMOVED. A SECOND FILTER WAS SUCCESSFULLLY PLACED WITH NO PT COMPLICATIONS AND THE PT HAS SINCE BEEN DISCHARGED. THIS DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE NO FAILURE ANALYSIS WILL BE AVAILABLE. NO MALFUNCTION OF THIS DEVICE WAS REPORTED TO HAVE OCCURRED. PLACEMENT OF AN INAPPROPRIATE FILTER CONTRIBUTED TO THIS EVENT. CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE.
THE PATIENT SIMULATOR, FOR USE DURING TESTING, WILL BE REPLACED TO ENHANCE CUSTOMER CONFIDENCE. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
DURING ROUTINE TESTING USING A PATIENT SIMULATOR, THE DEVICE ANALYZED AND ALLEGEDLY ADVISED NO SHOCK ON VENTRICULAR FIBRILLATION.
THE CATHETER WAS PLACED PREOPERATIVELY IN THE RIGHT RADIAL ARTERY. POSTOPERATIVELY THE NURSE NOTICED OOZING FROM THE ARTERIAL LINE AND IT WAS FOUND TO BE SEPARATED. THE PT WAS RETURNED TO THE OPERATING ROOM WHERE THE FRAGMENT WAS SUCCESSFULLY REMOVED.
INFECTION CONTROL HAS REPORTED AN ALL TIME HIGH IN UTI'S IN 9 YEARS., AVERAGE LENGTH OF STAY IS 11 DAYS. THIS PROBLEM WAS NOTED IN THE SNF AND ONE OTHER FLOOR (MED/SUG). THE INCREASE IN UTI'S STARTED 4-5 MONTHS AGO, WHICH WAS APPOROX 3 MONTHS AFTER IMPLEMENTATION OF DOVER. RN'S HAD INSERVICE, BUT ARE UP AGAIN.
REFERENCE MFR. COMPLAINT #K96-8-26-206-207. TWO SAMPLES WERE RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND NO IRREGULARITIES. AIR LEAKAGE AND FUNCTIONAL TESTS REVEALED NO LEAKAGE OR DISCONNECTS. MEASUREMENTS OF THE ID AND OD OF THE ISOPRENE TUBES FOUND THE OUTLET TUBES (OD) AND THE ISOPRENE TUBES (ID) TO BE OUT OF SPECIFICATION. THE PLANT ADVISED THAT THERE IS NOT ENOUGH INFO TO DETERMINE WHY THE BOTTON DRAIN TUBE MAY HAVE DISCONNECTED. THE ID/OD IRREGULARITY MAY HAVE CONTRIBUTED TO THE FORMAN VALVE FALLING OFF THE PRODUCT. THE PLANT HAS INITIATED AN INCOMING INSPECTION OF THE OUTLET TUBES. THE SUPPLIER HAS BEEN NOTIFIED FOR THIER INVESTIGATION AND CORRECTIVE ACTION. REVIEW OF THE LOT HISTORY WAS UNREMARKABLE. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUR INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
RN EXPERIENCED REDNESS, ITCHING, HIVES ON HER HANDS, SNEEZING, COUGHING, WHEEZING, AND SWOLLEN EYES AFTER USING LATEX GLOVES. REACTION HAS OCCURRED ON SEVERAL OCCASIONS. SHE TESTED POSITIVE FOR LATEX HYPERSENSITIVITY.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED AN AXIALLY-DIRECTED TEAR. MICROSCOPIC EXAMINATION: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY REVEALED EVIDENCE OF SEVERAL SURFACE ABRASION, PARALLEL AND ADJACENT TO THE TEAR EDGE. ALTHOUGH THE EXACT CAUSE FOR THE BALLON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
ON SEVERAL OCCASIONS STAFF ATTACHED SETS TO THE IV BAGS BUT THERE WAS NO OUTPUT DELIVERED. DATE OF EVENT: 9/26 - 4/10/96.
THE CUSTOMER IS A FIRST TIME USER TEST STRIPS WHO REPORTED INACCURATELY HIGH BLOOD GLUCOSE TEST RESULTS. ON 8/8/96 SHE OPENED A NEW BOTTLE AND PERFORMED TWO (FASTING AM) BLOOD GLUCOSE TESTS. THE RESULTS WERE 228 AND 239 MG/DL. BECAUSE SHE FELT THE RESULTS WERE NOT ACCURATE SHE PERFORMED TWO BLOOD GLUCOSE TESTS WITH OTHER TEST STRIPS. THE RESULTS WERE 164 AND 184 MG/DL. THE OTHER TEST STRIPS ARE LOT # (623694, CODE 8, EXPIRATION 8/98). THE CUSTOMER IMMEDIATELY CALLED THE CO CUSTOMER SUPPORT LINE AND, WITH THE REP, PERFORMED A BLOOD GLUCOSE TEST USING THE OTHER STRIPS. THE RESULT WAS 145 MG/DL. SHE THEN CHANGED THE CODE TO (10) AND PERFORMED A BLOOD GLUCOSE TEST WITH THE SUBJECT STRIPS. THE RESULT WAS 222 MG/DL. A NORMAL CONTROL SOLUTION TEST WAS PERFORMED ON BOTH BRANDS OF TEST STRIPS WITH DIFFERENT BRAND NORMAL CONTROL SOLUTION LOT #VJ641, EXPIRATION 8/98. THE RESULT WITH SUBJECT STRIPS WAS 174 MG/DL VERSUS A CONTROL RANGE OF 108-162 MG/DL. THE CODE WAS THEN CHANGED BACK TO (8) AND A CONTROL TEST WAS PERFORMED WITH THE OTHER STRIPS. THE RESULT WAS 82 MG/DL VERSUS A CONTROL RANGE OF 78-110 MG/DL. ALSO WITH THE REP, A CHECK STRIPS TEST WAS PERFORMED WITH A RESULT OF 80 VERSUS A RANGE OF 72-98. THE DESICCANT IS IN THE OPEN BOTTLE.
RETENTION SAMPLE WAS COMPARED WITH REFERENCE METHOD (YSI) AND MET ALL SPECS FOR ACCURACY AND PRECISION. CONTROL VALUES WERE WITHIN RANGE. CUSTOMER DID NOT RUN COMPARISON WITH AN ACCEPTABLE REFERENCE METHOD. PRODUCT SHOULD NOT BE COMPARED TO OTHER TEST STRIPS WHICH THEMSELVES MAY BE INACCURATE. ERROR GRID ANALYSIS INDICATES THAT CUSTOMER'S TEST STRIPS MAY PRODUCE RESULTS WHICH LIE IN ZONE B AND DO NOT REPRESENT A REASONABLE RISK OF SERIOUS INJURY. CO CANNOT CONFIRM THIS COMPLAINT. CO REQUESTED THAT THE PRODUCT BE RETURNED FOR EVAL ON 8/8/96. AS OF 9/6/96, PRODUCT HAS NOT BEEN REC'D. NO FURTHER INVESTIGATION IS POSSIBLE. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? NO. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
RPTR STATED, WHEN SHE IS AROUND LATEX PRODUCTS, SHE EXPERIENCES SNEEZING, CONJUNCTIVITIS AND TIGHTNESS IN HER CHEST.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED A LEAK SOURCE, 3.7 CM AT THE DISTAL END. MICROSCOPIC EXAMINATION: FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS IN THE BALLOON MATERIAL, ADJACENT AND INTERSECTING THE LEAK SOURCE. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
CUSTOMER STATED THAT HE BELIEVES THAT A SPLIT CONDOM LEAD HIM TO CONTRACTING THE HERPES INFECTION. HE FURTHER STATES THAT HE WAS DIAGNOSED WITH THIS INFECTION BY A CLINIC.
SILICONE IMPLANT RUPTURED. IMPLANTED AT ANOTHER FACILITY.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. REPORT RECEIVED FROM THE FIELD INDICATED THAT, DURING CLINICAL USE, THE BALLOON BURST AT 4 ATMS. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. REPORTEDLY, THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. THIS FILE IS CONSIDERED CLOSED. SHOULD THE PRODUCT BE RETURNED AT A LATER DATE, A FOLLOW UP WILL BE SUBMITTED.
THE CATHETER WAS PLACED PRE-OP IN THE PT'S RIGHT RADIAL ARTERY. AFTER THE OPERATION, THE NURSE NOTICED OOZING FROM THE CATHETER AND FOUND IT HAD SEPARATED. THE PT WAS RETURNED TO THE OPERATING ROOM WHERE THE SEPARATED CATHETER PORTION WAS REMOVED WITHOUT COMPLICATION.
THE DEVICE DIDN'T STOP AUTOMATICALY. (NOTE: THERE WAS NO INDICATION OF PT INJURY).
DEVICE EVALUATION SUMMARY: NO DISCREPANCIES NOTED IN MFG HISTORY RECORDS FOR THIS LOT. DEVICE WAS VISUALLY INSPECTED. HARDENED CASE DEBRIS WAS NOTED ON UNIT. DEBRIS WAS REMOVED UNIT WAS TESTED FOR PROPER FUNCTION AND PERFORMED PROPERLY FOR TEN TEST HOLES. THE REPORTED FAILURE COULD NOT BE REPEATED. INTERNAL COMPONENTS APPEARED NORMAL.
THE BALLOON OF THIS DEVICE BURST DURING AN ANGIOPLASTY PROCEDURE, THERE HAS BEEN NO CLAIM OF INJURY RELATED TO THIS EVENT. NO ADD'L NFO HAS BEEN MADE AVAILABLE.
MICROSCOPIC INSPECTION OF BALLOON DID NOT REVEAL CAUSE OF FAILURE. DEMENSIONAL INSPECTION OF THE BALLOON REVEALED IT TO BE WITHIN DESIGN SPECS.
THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AND TESTING. THIS FILE IS CONSIDERED CLOSED. SHOULD THE PRODUCT RETURNED AT A LATER DATE, A FOLLOW-UP WILL BE SUBMITTED FOR YOUR REVIEW.
FOLLOWING SURGICAL PROCEDURE, PT IN POST ANESTHESIA CARE UNIT. ALBUTERAL TREATMENT ORDERED. DURING INITIAL HOOK-UP, EXHALATION PART OF T-PIECE OCCLUDED. ERROR DISCOVERED IMMEDIATELY. PT PLACED ON VENTILATOR TEMPORARILY. PT IMPROVING, NO PERMANENT DAMAGE EVIDENT OR EXPECTED.
THE CUSTOMER'S HUSBAND REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH STRIPS, LOT # 1J520B. THE CUSTOMER OPENED THE BOTTLE APPROX 3 DAYS AGO AND PERFORMED A BLOOD GLUCOSE TEST. THE RESULT WAS 17 MG/DL. SHE DID NOT BELIEVE THIS READING TO BE CORRECT, SO SHE PERFORMED A BLOOD GLUCOSE TEST WITH OTHER TEST STRIP (LOT #40967 1 A, EXP. 010/97) AND THE RESULT WAS 115 MG/DL. A NORMAL CONTROL SOLUTION TEST WAS PERFORMED WITH THE CO REP ON SUBJECT TEST STRIPS AND THE RESULT WAS 5 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 120-180 MG/DL. ANORMAL CONTROL SOLUTION TEST WAS ALSO PERFORMED ON OTHER TEST STRIP AND THE RESULT WAS 109 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 86-122 MG/DL. THE SOLUTION WAS OPENED FOR THE FIRST TIME ON 8/9/96 AND THE CUSTOMER SHOOK IT WELL BEFORE TESTING. A CHECK STRIP TEST PERFORMED WITH THE CO REP GAVE A RESULT OF 87 VERSUS A CHECK STRIP RANGE OF 78-99. THE CODE WAS SET CORRECTLY FOR ALL TESTS. THE DESICCANT IS IN THE BOTTLE OF SUBJECT TEST STRIP.
RETENTION SAMPLE FOR LOT 1 J520B MET ALL SPECS FOR ACCURACY AND PRECISION. CONTROL VALUES WERE WITHIN RANGE. CO REQUESTED THAT THE PRODUCT BE RETURNED FOR EVAL ON 8/9/96. CO WILL FORWARD A FOLLOW-UP TO THIS REPORT UPON RECEIPT OF RETURNED TEST STRIPS. TIME FRAME IS UNKNOWN. IS EVENT OCCURING MORE FREQENTLY THAN STATED IN LABELING? NO. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO.
CLOTTING AT THE TIP AND SIDEARM, USED FOUR ITEMS RETURNING ONE. USING HEPARIN FLUSH, AND FLUSHING IT FREQUENTLY PROCEDURE LENGTH IS 45 MINUTES FOR RIGHT HEART CATHETERIZATION.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO PROVIDED BY CO. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE SIDEPORT TUBING, DISTAL TO THE VALVE BODY INTERFACE. ALSO, ON THE GASKET AND UNDERNEATH THE SUTURE COLLAR/CAP ASEMBLY, THE SHEATH EXHIBITED BEND-TYPE KINKS, DISTAL TO THE CANNULA/BODY INTERFACE. DIMENSIONAL EXAMINATION: THE INNER DIAMETER OF THE CANNULA'S BODY WAS FOUND TO BE WITHIN DIMENSIONAL SPECIFICATION. THE SHEATH CANNULA WAS CROSS-SECTIONED LONGITUDINALLY AND NO BLOOD RESIDUE WERE NOTED. ALTHOUGH THE EXACT CAUSE FOR THE CLOTTING COULD NOT BE DETERMINED, IT IS POSSIBLE THAT THE CLOTTING MIGHT BE RELATED TO THE BEND-TYPE KINKS IN THE SHEATH.
THE BALLOON OF THIS DEVICE BURST DURING AN ANGIOPLASTY PROCEDURE. THERE WAS NO OTHER INFO AVAILABLE. REVIEW OF DHR REVEALED NO RELATED OBSERVATIONS.
THIS DEVICE WAS RETURNED IN UNOPENED STERILE TRAY. THE DEVICE WAS NOT USED, BUT THE LOT NUMBER MATCHED THAT OF THE REPORTED UNIT.
DURING PROGRAMMING WITH THE PT SUPINE IN BED, THERE WERE 19 CONSECUTIVE AV SEQUENTIAL PACES AT THE MAXIMUM PACING RATE. SHE WAS PROGRAMMING FROM VENTRICULAR UNIPOLAR AT 2.7V TO BIPOLAR AT 5.5V. NURSE TO FED EX PROGRAMMER/ECG STRIPS.
IF THE PACEMAKER HAS RATE ADAPTION PROGRAMMED ON AND IS DETECTING A LIGHT LEVEL OF EXERCISE, WHEN PROGRAMMED, THE DEVICE WILL PACE AT THE MAXIMUM PACING RATE FOR TWO CYCLES. IF THE USER ATTEMPTS TO PROGRAM THE DEVICE AGAIN DURING THE TWO FAST BEATS(THIS WOULD ONLY OCCUR BY MISTAKE), THE DURATION OF THE FAST BEATS WILL BE EXTENDED UNTIL THE END OF THE NEW PROGRAMMING OPERATION.
AFTER C-SECTION, EPIDURAL CATHETER WAS REMOVED BY DR. A PORTION REMAINED IN PT'S BACK. (UNKNOWN AMOUNT) DR EXCISED SITE BUT UNABLE TO SEE REMAINDER OF CATHETER. X-RAY OBTAINED, STILL UNABLE TO SEE REMAINDER OF CATHETER.
THE BALLOON BURST AT 14 ATMS DURING POST STENT DILATATION. THIS BALLOON WAS USED FOR PRE-DILATATION.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: TRACES OF LIQUIFIED BLOOD WERE NOTED WITHIN THE BALLOON AND INNER BODY. THE BALLOON EXHIBITED A 0.7 CM LONG, AXIALLY-DIRECTED TEAR, 1.2 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAMINATION: FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING AND ADJACENT TO THE AXIAL TEAR EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON TEAR COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
SUNBURN LIKE REACTION WHEN PADS UTILILIZED DURING CARDIOVERSION. TRENDED FROM 6/1 TO 8/14. 15/28 PTS (54%) SUFFERED REACTION, MANY REQUIRING TREATMENT WITH TOPICAL XYLOCAINE JELLY.
THE MONITOR WAS STUCK AND SEPARATED FROM THE BASE WHILE USER WAS ATTEMPTING TO POSITION THE MONITOR.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT LOSS. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A MES (MEDICAL EQUIPNMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT A SIMILAR CONDITION OCCURRED ON 10/95. HOWEVER, THIS FAILURE WAS TRACED TO A LEAKING P-3 CONNECTOR. THIS IS NOT RELATED TO THE FAILURE IN THIS COMPLAINT. THE HISTORY ALSO SHOWS A SECOND COMPLAINT FOR THE THERMAL FUSE. THE SAME FUSE FAILURE AFECTED TWO PTS: THIS COMPLAINT ADDRESSES THE SECOND PT INCIDENT, AND COMPLAINT #0996046 ADDRESSES THE FIRST PT INCIDENT. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
EIGHT CATHETERS HAD BALLOONS WHICH DID NOT INFLATE EITHER WHEN TESTED OR AFTER INSERTION INTO PT. THOSE WHICH WERE INSERTED REQUIRED REMOVAL AND REINSERTION.
DURING A DIALYSIS TREATMENT, THERE WAS A WEIGHT GAIN DUE TO FAILURE OF THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SEPCIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION ) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM, INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED; PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION(P. 3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
ERRATIC PT RESULTS WERE OBTAINED ON THE PHENYTOIN ASSAY WHILE OPERATING THE ANALYZER. ON 8/3/96, A PT RESULT OF 0.1 UG/ML WAS REPORTED ON THE PHENYTOIN ASSAY. THE PHYSICIAN TREATED THE PT AND A SECOND SPECIMEN WAS COLLECTED WHICH RESULTED IN A 44.4 UG/ML AND 40.0 UG/ML WHEN REPEATED. THE PHYSICIAN QUESTIONED THE RESULT FROM AUGUST 3, 1996 AND IT WAS REPEATED ON 8/8/96 WITH A RESULT OF 21.34 UG/ML. NO REPORT OF INJURY.
INVESTIGATION SUMMARY: THE EVENT REPRESENTED IS NOT ADDRESSED IN THE DEVICE LABELING. A MALFUNCTION DID NOT OCCUR. THIS REPORTABLE MDR EVENT WAS  INVESTIGATED AS PART OF AN ONGOING STUDY OF THE AXSY SYSTEM BY ABBOTT INTO THE CAUSATIVE REASON FOR MALFUNCTIONS. RESULTS OF THE INVESTIGATION YIELDED A NUMBEROF SYSTEM ENHANCEMENTS IMPLEMENTED ON CUSTOMER UNITS. IMPROVEMENTS INCLUDED AXSYM SYSTEM SOFTWARE VERSION 3.0 WITH ENCHANCED ALGORITHM FOR FULID DETECTION, NEW BUFFER TUBING AND SEAL FITTINGS WHICH REDUCED BUBBLES FORMING IN TUBING LINES, MODIFICATIONS TO THE LIQUID LEVEL SENSE BOARD TO DECREASE SENSITIVITY OF THE INSTRUMENT TO ELECTROSTATIC DISCHARGE, AND PACKAGING MODIFICATIONS FOR ADDED PROTECTION TO PROBES. IN ADDITION, ABBOT HAS EMPHAZIED TO OUR CUSTOMERS THAT CORRECT OPERATING PROCEDURES MUST BE FOLLOWED TO ENSURE OPTIMAL PERFORMANCE OF THE AXSYM SYSTEM. AREAS THAT WERE EMPHASIZED INCLUDED PROBE CRASH RECOVERY PROCEDURE, RECOMMENDED TUBE SIZE AND TYPES, OPENING REAGENT BOTTLE 4, PROPER LOADING/UNLOADING OF REAGENT PACKS, AND ENSURING PROPER SAMPLE AND REAGENT HANDLING. THIS IS THE FINAL REPORT.
DURING A DIALYSIS TREATMENT, THERE WAS WEIGHT GAIN OF 0.4KG. PT UNDERWENT AN UNSCHEDULED TREATMENT TO REMOVE THE WEIGHT. THE MED (MEDICAL EQUIPMENT SERVICE) TECHNICIAN FOUND NO PROBLEMS WITH THE MACHINE. ON 9/4/96, CONDITION RECURRED (FIRM #0996061 & #0996062) AND THE UF (ULTRAFILTRATION) PUMP WAS REPLACED.
DURING A DIALYSIS TREATMENT, A PT WEIGHT GAIN WAS REPORTED. THE PT UNDERWENT A SECOND, UNSCHEDULED TREATMENT. A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND FOUND NO PROBLEM. ON 9/4/96, THE CONDITION RECURRED AND THE UF PUMP WAS REPLACED. A REVIEW OF THE DRF HISTORY DOES SHOWS THAT TWO OTHER INCIDENTS RESULTED FROM THE COMPONENT FAILURE INVESTIGATED IN THIS COMPLAINT. IN THIS COMPLAINT, THE INVESTIGATION BY THE FIELD REP SHOWED NO PROBLEMS, SO NO COMPONENTS WERE REPLACED. THE ABOVE MENTIONED COMPLAINTS WERE GENERATED WHEN THE FIELD REP LATER IN THE WEEK HAD TO RETURN TO THE MACHINE BECAUSE TWO ADD'L PT HAD WEIGHT REMOVAL PROBLEMS, GENERATING THE TWO NEW COMPLAINTS/MDR'S DOCUMENTED. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE FIELD REP ORIGINALLY FOUND NO PROBLEM WITH THE UF (ULTRAFILTRATION) PUMP. THEREFORE, NO PRODUCT WAS RETURNED FOR INVESTIGATION FOR THIS COMPLAINT. HOWEVER, THE PRODUCT WAS LATER FOUND DEFECTIVE AND THIS INVESTIGATION WAS DOCUMENTED IN LATER COMPLAINTS. BASED ON RELATED COMPLAINT INVESTIGATIONS FOR THIS MACHINE, IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR:N TRAINING REQUIRED:N.
AFTER A CORONARY ANGIOGRAM, CARDIOLOGIST NOTED THAT HE COULD NOT REMOVE THE STABILIZER GUIDE WIRE. UPON REVIEWING THE RADIOGRAPHIC IMAGES, HE NOTED THAT THE GUIDE WIRE'S END WAS FRACTURED. SURGERY WAS REQUIRED TO REMOVE THE GUIDE WIRE. THIS WAS DONE IN CONJUNCTION WITH OTHER NECESSARY OPEN HEART SURGERY. DISCUSSED WITH MFR'S REP.
PACEMAKER LEAD PERFORATED THE PT'S HEART AND PRODUCED HEMOPERICARDIUM.
THE HUB OF THIS DEVICE SEPARATED DURING THE PROCEDURE. THERE IS NO REPORT OF PT INJURY. THE DEVICE IS NOT BEING RETURNED FOR OUR ANALYSIS.
THIS COMPLAINT INVOLVED A PT UNDERGOING AN EMERGENCY ABDOMINAL AORTIC ANEURYSM REPAIR. AN ARTERIAL CATHETER WITH A PRESSURIZED BAG OF HEPARINIZED SALINE WAS IN USE. THE DELIVERY RATE OF THE FLUSH SOLUTION SHOULD BE APPROX 3 ML/HR. THE SYSTEM REPORTEDLY INFUSED APPROX 300 ML OF FLUSH SOLUTION OVER A 2 HOUR PERIOD. THE PT EXPIRED DURING THE SURGICAL PROCEDURE. HE HAD REC'D ADD'L IV DOSES OF HEPARIN AFTER THE FLUSH PROBLEM WAS NOTED. THE PHYSICIANS INVOLVED IN THE CARE OF THE PT STATED THEY SAW NO CORRELATION BETWEEN THIS EVENT AND THE SUBSEQUENT PT DEATH.
THE DEVICE SAMPLE IS EXPECTED, BUT HAS NOT YET BEEN REC'D FOR TESTING AND ANALYSIS.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT REMOVAL. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
DURING A DIALYSIS TREATMENT, AN INSUFFICIENT WEIGHT LOSS WAS REPORTED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REPORTED. A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND THE UF PUMP WAS REPLACED AS A PRECAUTION. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT TWO OTHER INCIDENTS RESULTED FIRST WHEN A PT INCIDENT WAS REPORTED, BUT THE FAILURE MODE WAS NOT DETERMINED BY THE FIELD REP, AND NO PART WAS REPLACED. THIS COMPLAINT AND 0996062C3 REPRESENT MDR'S FOR TWO PTS WHEN THE PUMP FAILED AGAIN LATER IN THE SAME WEEK FOLLOWING THE 0996060C3 COMPLAINT. A REVIEW OF THE UF PUMP TRACE NUMBER SECONDARY DTF SEARCH SHOWED NO RELATED INCIDENTS. THE TECHNICIAN AT THE FACILITY FOUND THE UF (ULTRAFILTRATION) PUMP TO BE FAULTY AND RETURNED THE ENTIRE PUMP FOR INVESTIGATION. THE THERMAL FUSE WAS REMOVED FROM THE RETURNED UF PUMP. THE THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE OHM METER SHOWED 0.2 OHMS, INDICATING THE THERMAL FUSE WAS POTENTIALLY STILL INTACT. HOWEVER, WHEN THE THERMAL FUSE WAS DISASSEMBLED, IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS. THIS IS WHAT THE FUSE IS DESIGNED TO DO.PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. CUSTOMER CONTACTED:N. SALES/SERVICE CONTACTED BY INVESTIGATOR:N. TRAINING REQUIRED:N.
DEVICES FROM THE SAME LOT NUMBER WERE EVALUATED. CODE 300 + NO PROBLEMS WERE OBSERVED IN ANY OF THE TESTING. PRODUCT EXCEEDED MFR. SPECIFICATIONS AND THE DISCONNECTS COULD NOT BE DUPLICATED. LOT HISTORY EVALUATION REVEALED NO FINDINGS RELATED TO THE COMPLAINT. CO WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED FAILURE. UNDER NORMAL CIRCUMSTANCES, THE PRODUCT SHOULD HAVE PERFORMED AS EXPECTED. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFORMATION NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
CONNECTOR SEPARATED FROM THE TUBE WHILE CHILD WAS SLEEPING ON ITS STOMACH, CONNECTOR WAS ATTACHED TO A SELF-HUMIDIFER. THE DEVICE WAS IN PLACE FOR 13 DAYS. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT.
THE HUB OF THIS DEVICE SEPARATED DURING THE PROCEDURE. THERE IS NO REPORT OF PT INJURY. THE DEVICE IS NOT BEING RETURNED FOR ANALYSIS.
DURING A DIALYSIS TREATMENT, AN OVER INFUSION OF HEPARIN OCCURRED. THERE WAS NO PT INJURY.
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
PT RECEIVED LEG BURN FROM CAUTERY PENCIL. STAFF BELIEVED THE CAUTERY WAS IN ACTIVATION STATE WHEN PLUGGED INTO THE GENERATOR.
A RETAINED SAMPLE OF THE SAME LOT WAS TESTED. PENCIL TESTED WITHIN CO SPECS. COULD NOT CONFIRM OR DUPLICATE THE REPORTED EVENT.
GUIDE WIRE PERFORATED RIGHT CORONARY ARTERY CAUSING PERICARDIAL EFFUSION AND CARDIAC TAMPONADE.
DECREASED STAINING INTENSITY OF POSITIVE CONTROL AND SAMPLES USING CMV-VUE KIT. KIT CONTAINS INSTRUCTIONS AND MATERIALS FOR THE QUALITATIVE DETECTION OF EARLY STRUCTURAL PROTEIN OF CMV.
CO HAS NOT REC'D, OR IS AWARE OF, ANY INFO SUGGETING THAT THE PRODUCT HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR DEATH. CO HAS TAKEN APPROPRIATE REMEDIAL ACTION TO REMOVE THE AFFECTED LOTS FROM THE FIELD AND TO PREVENT ANY SIMILAR RECURRENCE IN FUTURE SHIPMENTS OF THE KIT. A TOTAL OF 67 KITS WERE DISTRIBUTED TO 15 CUSTOMERS. THE LOT NUMBERS AFFECTED ARE 315676, 315676A. CO REC'D ONE CUSTOMER COMPLAINT REGARDING DECREASED STAINING INTENSITY IN POSITIVE CONTROLS AND SAMPLES USING CO CATALOG # 24300, CMV UVE KIT. THIS PHENOMENON WAS CONFIRMED IN HOUSE AND ATTRIBUTED TO CONJUGATE STABILITY. CO HAS RECALLED AND REPLACED ALL KITS. A HEALTH HAZARD EVAL WAS PERFORMED EVEN INDICATED THAT THIS SITUATION POSES A MODERATE RISK TO THE PT DUE TO THE POTENTIAL FOR LOW POSITIVE SAMPLES TO BE INTERPRETED AS FALSE NEGATIVE IN CMV POSITIVE PTS.
INVESTIGATION CONDUCTED. DR CITES MIGRATION OF EPITHELIAL TISSUE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
ON 8/16/96, THE MFR'S SALES REP REPORTED THAT THE PHYSICIAN ORDERED PRODUCT FOR SURGERY SCHEDULED AT 7 AM ON 8/15/96. HOWEVER, WHEN THE MFR SALES REP OPENED THE BOX IN O.R. THE WRONG PRODUCT WAS DISCOVERED. THE MFR SALES REP HAD THE CORRECT PRODUCT AVAILABLE. THIS INCIDENT OCCURRED PRIOR TO SURGERY, THE PT WAS NOT INVOLVED AND THERE WAS NO DELAY IN SURGERY.
THE MFR' SHIPPING DEPT HAS BEEN NOTIFIED OF THIS INCIDENT AND CORRECTIVE ACTION WILL BE IMPLEMENTED TO PREVENT REOCCURRENCE OF THIS EVENT, IF DEEMED NECESSARY. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND DID NOT REVEAL ANY TRENDS. NO FURTHER INFO IS AVAILABLE. THE MDR IS CLOSING THE FILE ON THIS EVENT.
PT TO CATH LAB FOR REMOVAL OF FRACTURED RETENTION WIRE ATRIAL LEAD OF PACEMAKER. ANOTHER MFR'S LEAD EXTRACTION SOFT TEFLON SHEATH USED INITIALLY - VENTRICULAR WIRE MOVING WITH ATTEMPTS TO EXTRACT. OUTER SHEATH CHANGED TO STIFFER POLY-PROPYLENE SHEATH - COULD NOT NAVIGATE PAST BEND. PT'S BP DROPPED PRECIPITOUSLY (DOWN INTO 50'S). PT CODED AND RUSHED TO OR - SUBCLAVIAN VEIN PUNCTURED - PT UNABLE TO BE RESUSCITATED.
DISTRIBUTOR RECEIVED TWO LEADS FOR ANALYSIS. THE LEADS WERE PART OF A 4 LEAD/ICD THAT WAS REMOVED FOR POCKET INFECTION. THERE WAS NO ALLEGATION OR COMPLAINTS RECEIVED AGAINST ANY OF THE LEADS OR THE ICD. THIS REPORT WAS CREATED AS A RESULT OF THE RETURN PRODUCT ANALYSIS. BOTH LEADS EXHIBITED INSULATION ABRASIONS THAT EXPOSED THE CONDUCTOR COIL. THE MORPHOLOGY AND LOCATION OF THE ABRASIONS ARE TYPICAL OF LEAD ON ICD CASE OR LEAD-ON-LEAD CONTACT.
THE PRODUCT WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE KNOTS WERE UNTYING.
A LAB TECHNICIAN WAS REPORTEDLY DISPOSING OF A 1000 ML EVACUATED CONTAINER (BOTTLE) INTO A SHARPS CONTAINER WHEN THE BOTTLE" EXPLODED". THE BOTTLE CONTAINED PERITONEAL BODY FLUID. WHICH SPLASHED INTO THE EYES, NOSE AND MOUTH AND ONTO THE SKIN OF THE EMPLOYEE. THE EMPLOYEE WAS EXAMINED IN THE EMERGENCY ROOM PER HOSP PROTOCOL. THE PT FROM WHICH THE PERITONEAL FLUID WAS OBTAINED WAS HIV NEGATIVE. THE PERITONEAL FLUID WAS BEING CULTURED FOR BACTERIA AND FUNGUS. THE TECHNICIAN HAD PREVIOUSLY INJECTED AIR INTO THE CONTAINER TO AID IN REMOVING FLUID FOR TESTING.
THE PRODUCT LIST NUMBER WAS NOT AVAILABLE, THUS MFR DATE COULD NOT BE DETERMINED.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON "NORMAL" OR "INFECTION". NO FURTHER INFO IS AVAILABLE.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT IS A SMOKER, CONSUMES ALCOHOL AND IS A BRUXER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE INCIDENT OCCURRED ON A PT WHEN THE SYSTEM WAS PUT INTO STANDBY TO CALIBRATE ARTERIAL PRESSURE. THE VOLUME DROPPED TO 5 CC, EVEN THOUGH THEY HAD BALLOON CONNECTORS PLUGGED IN. THE HOSP TRIED ANOTHER BALLOON CONNECTOR AND IT DID NOT CHANGE AND VOLUME STAYED AT 5 CC. COULD NOT GET PUMP TO RETURN TO 40 CC EVEN AFTER TRYING ANOTHER BALLOON CONNECTOR. THE HOSP MADE THE DECISION TO SWITCH THE PT TO ANOTHER PUMP. THERE WERE NO PT COMPLICATIONS.
MFR CONTROL NO. DI96-168. THE FIELD SERVICE REPRESENTATIVE INVESTIGATED THIS INCIDENT ON 8/7/96. HE REPLACED THE INTERFACE BLOCK AND PERFORMED A COMPLETE CHECK OF THE PUMP. IT PERFORMED NORMALLY.
PT WAS TERMINALLY ILL AND IN A PERMANENT UNCONSCIOUS STATE. HE WAS WITHDRAWN FROM VENTILATORY SUPPORT AS ALLOWED BY LAW - S.B.I. AND PER HIS DIRECTIVES UNDER HIS LIVING WILL. ONCE REMOVED FROM THE VENTILATOR HE HAD RAPID RESPIRATIONS OF 32-36 PER MIN. THE PHYSICIAN ORDERED A TITRATED MORPHINE DRIP OF 2CC PER HR FOR PURPOSES OF COMFORT CARE, WHICH WOULD BE 2MG PER HR. THE PT WAS ALSO SUPPORTED WITH A 100% FIO2 MASK. THE IV MORPHINE WAS RUN THROUGH THE IV PUMP AND THE PRIMARY KEEP OPEN IV WAS PIGGYBACKED TO THE MORPHINE DRIP BELOW THE PUMP. IT WAS NOTICED THREE AND A HALF HRS LATER THAT THE BAG WAS DRY. THE PT CEASED RESPIRATIONS 25 MIN LATER. IT SHOULD BE NOTED THAT THE PT WAS EXPERIENCING PERIODS OF APNEA, AS HAD BEEN EXPECTED FROM THIS WEANING PROCESS.
INVESTIGATION CONDUCTED. DR CITES INFECTION AND POOR ORAL HYGIENE AS CAUSE FOR FAILURE. PT DEVELOPED DIABETES. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT VISIT MADE TO CHANGE PICC LINE DSG AND DRAW LABS. IT WAS DISCOVERED THAT PICC LINE CATHETER HAD BROKEN AT CONNECTION OF CATHETER AND HUB. CATHETER WAS HELD IN PLACE BY STAT-LOK ANCHORING DEVICE AND TRANSPARENT DSG. PICC LINE WAS REPAIRED BUT CATHETER WAS OCCLUDED. PICC LINE DC'D. PT HAD TO HAVE SURGICAL PROCEDURE FOR PLACEMENT OF ANOTHER CATHETER.
A VAGUE REPORT WAS REC'D THAT THE INFUSION PUMP WAS INVOLVED IN AN UNDERDELIVERY. THE SPECIFIC INFUSION RATE AND QUANTITY OF SOLUTION INVOLVED WERE NOT REPORTED. NO PT INJURY OCCURRED. THE SERIAL NUMBER OF THE INFUSION PUMP WAS NOT REPORTED. THE REPORTER COMMENTED THAT THE INFUSION PUMP WAS EVALUATED BY THE HOSP BIOMED. DEPT. AND THE REPORTED OCCURRENCE COULD NOT BE REPLICATED.
THE PHYSICIAN ATTEMPTED A JUGULAR APPROACH FOR VENA CAVA FILTER PLACEMENT AND WAS UNABLE TO GAIN ACCESS. HE THEN ATTEMPTED A FEMORAL APPROACH. AS HE ADVANCED THE FILTER THROUGH THE SHEATH, THE FILTER BECAME BOUND IN THE SHEATH. TEH SHEATH WAS CUT AND LEFT IN THE PT. A SECOND FILTER WAS PLACED THROUGH A SUCCESSFUL JUGULAR APPROACH AND REMAINS IN A POSITION SUPERIOR TO THE FEMORALLY PLACED FILTER. THE PT REMAINS STABLE AND, TO DATE, HAS SUFFERED NO ADVERSE EFFECTS FROM THE PROCEDURE.
SAMPLE IS BEING EVALUATED BY MFR. ADD'L INFO TO FOLLOW. DISCLAIMER: B BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, VOLUME 49, RELEASE NUMBER 180, DATED FRIDAY SEPTEMBER 14, 1984, SECTION 803 (MEDICAL DEVICE REPORTING) SUBSECTION 803.24. B BRAUN MEDICAL INC DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CAUSAL RELATIONSHIPS TO DEVICES MFG OR DISTRIBUTED BY B BRAUN MEDICAL INC.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SAFETY SHIELD DID NOT RETRACT. THE HOSPITAL REPORTED NO PT INJURY.
THE BALLOON BURST ON THE 3RD INFLATION AT 8 ATMS.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO PROVIDED BY CO. REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING CLINICAL USE, THE BALLOON BURST ON THE 3RD INFLATION AT 8 ATMS. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. THE PRODUCT IS TO BE RETURNED TO CO FOR EVAL AND TESTING, BUT HAS NOT YET BEEN RECEIVED. PLEASE NOTE DATE OF 10/16/96 FOR SUBMISSION OF SUCH INFO PENDING. THE PRODUCT RETURNED AND COMPLETION OF THE ANALYSIS.
INVESTIGATION CONDUCTED. DR CITES SURGICAL TRAUMA AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT WAS POST-OP. HAD HEPARIN RUNNING THRU PUMP. PUMP REGULATED AND FAILED TO FUNCTION. PT RECEIVED TOO MUCH HEPARIN NECESSITATING RETURN TO OR TO EVACUATE CLOTS. RECEIVED 250CC IN 7HRS INSTEAD 21CC/7HR. PER CALL TO RPTR: PROCEDURE WAS FEM POP BYPASS. FACILITY IS OF THE OPINION THAT CLOTTING WAS RESULT OF HYPERINFUSION OF HEPARIN.
MOUNTING POST CRACKED AND BROKE OFF; ARM ASSEMBLY FELL WITH INJECTOR HEAD. NO INJURY RESULTED.
THE MOUNTING POST BROKE AFTER APPROX EIGHT YEARS OF CONSTANT USE. THE MOUNTING POST ASSEMBLY (YOKE) WAS REPLACED WITH A NEW GENERATION YOKE CONTAINING A THICKER POST. THIS EXPECTED TO INCREASE THE USAGE/LIFE EXPECTANCY OF THE MOUNTING POST.
DURING A CATARACT EXTRACTION PROCEDURE, THIS OPHTHALMIC MICROSURGICAL SYSTEM EXHIBITED LOW ASPIRATION. THE TUBING, CASSETTE AND HANDPIECE WERE EXCHANGED THEN ANOTHER SYSTEM WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. THE DATE USED IN SECTION F.13 IS THE DATE THE REPORT WAS REC'D BY THE MFR.
PT HAD SURGERY ON 9/15/96: OPEN REDUCTION OF RT RING FINGER USING CO'S 5   HOLE PLATE AND 4 SCREWS. THE PT CAME BACK FOR REVISION OF RIGHT RING FINGER METACARPAL FRACTURE BECAUSE THE PLATE PULLED OFF THE FRACTURE SITE. THE SCREWS WERE 2.0 MM CORTEX SCREWS 10MM. IT WAS FOUND THAT THREE OF THE SCREW HEADS WERE SMALLER EVEN THOUGH THEY WERE ALL THE SAME SCREWS - CO WAS NOTIFIED OF PROBLEM.
THE PT RECEIVED AN ASCITES SHUNT, CATALOG #42-4002, ON 7/25/95. RECENTLY THE PT'S ASCITES RETURNED. THE SURGEON OPERATED TO REPLACE THE OCCLUDED PORTION OF THE SHUNT AND UPON ENTRY COULD NOT FIND THE PERITONEAL CATHETER. FURTHER EXAMINATION SHOWED THAT THE PERITONEAL CATHETER HAD SEVERED FROM THE SHUNT AND WAS INSIDE THE PERITONEAL CAVITY. THE SURGEON PERFORMED LAPAROSCOPIC SURGERY TO RETRIEVE THE CATHETER, AND IMPLANTED A NEW SHUNT. THERE WERE NO PT INJURIES ASSOCIATED WITH THIS INCIDENT.
MICROSCOPIC EXAMINATION OF THE INCIDENT PRODUCT SHOWED THAT THE BREAKAGE OF THE PERITONEAL CATHETER WAS CAUSED BY NEEDLE TEARS THROUGH THE SIDE OF THE CATHETER. THESE TEARS LIKELY RESULTED WHEN THE SURGEON SUTURED THE INCISION SITE NEAR THIS AREA DURING IMPLANT, AND INADVERTENTLY CUT THE CATHETER WITH THE SUTURE NEEDLE. ONCE CUT, SILICONE RUBBER HAS VERY LOW TEAR RESISTANCE. THE INSTRUCTIONS FOR USE FOR THIS DEVICE CAUTION THE USER TO AVOID CUTTING OR PUNCTURING THE CATHETERS, AS LEAKAGE OR TEARING MAY OCCUR.
PT HAD A+P REPAIR ON 9/10/96. PACKING REMOVED, BLEEDING STARTED. DR WAS ABLE TO STOP BLEEDING BUT UPON EXAM DR FOUND 1 INCH OF SUTURE LINE (IN VAGINAL VAULT) COMPLETELY OPEN-ORIGINAL SUTURE. REPAIR WAS CHRONIC.
LADY APPROX 10 STONE HAD BEEN BATHED, SHE WAS RAISED OUT OF THE BATH AND ROTATED TO OUTSIDE THE BATH WHEN THE CHAIR WITH THE LADY ON IT DROPPED. NOT KNOWN IF ANY INJURY SUSTAINED AT THE TIME OF REPORT. MEDICAL OFFICER IS TO ATTEND. ONE PERSON INVOLVED.
IN THE INITIAL REPORT OF INJURY WAS UNK. IT HAS SINCE BEEN REPORTED THE CLIENT SUSTAINED A GRAZE TO THE ELBOW AND BACK STRAIN. UPON INSPECTION OF THE HOIST IT WAS NOTED THAT THE REAR CROSS MEMBER OF THE CHAIR FRAME CAN EASILY COME TO REST ON THE CORNER OF THE TUB IF THE CHAIR IS NOT SWUNG BEYOND 90 DEGREE C. MARKS ON BOTH THE CHAIR AND THE TUB INDICATE THIS SITUATION HAS ARISEN SEVERAL TIMES PREVIOUSLY AND IN THIS INSTANCE ALMOST CERTAINLY LED TO THE CHAIR COMING TO REST DURING LOWERING WITH SLACK BUILDING UP IN THE CHAIR AND SUBSEQUENT JIB DROP. INCIDENT WAS THE RESULT OF USER ERROR, IMPROPER TECHNIQUE IN USE OF EQUIPMENT. CENTRE ADVISED TO HAVE SPRAGG CLUTCH FITTED.
PT UNDERWENT SURGICAL PROCEDURE WITH FORCED AIR PT WARMER IN PLACE. EQUIPMENT ALARMED DURING PROCEDURE - EQUIPMENT TURNED OFF AND REMOVED. FOLLOWING THE PROCEDURE, SEVERAL RED AREAS NOTED ON PT'S RIGHT LEG. EXAMINATION REVEALED 1ST DEGREE BURN.
CAPSULAR CONTRACTURE. RIGHT BREAST. BREAST IMPLANT 11/30/93 HDH.
PT WAS RECEIVING ADENOSINE (20.61CC IN 14.39CC NS) PER SYRINGE PUMP FOR CARDIAC STRESS TEST. A 35CC SYRINGE WAS USED. THE DOSE OF MEDICATION COMPLETELY INFUSED IN 3.5 MINUTES VS. THE EXPECTED 6.0 MINUTES. THERE WERE NO ADVERSE EFFECTS ON THE PT ACCORDING TO THE INITIAL REPORTER.
ONLY ONE INFUSER HAS FAILED TO OPERATE AT THE 6 MINUTE RATE FOR CARDIAC STRESS TESTING ACCORDING TO CO'S COMPLAINT SYSTEM. ALL INFUSERS ARE 100% TESTED BEFORE SHIPPING. ALL INFUSERS ARE TRACKED TO THE CUSTOMER. AFTER TESTING AND EVALUATING THE ONE INFUSER THAT FAILED TO OPERATE AT THE 6 MINUTE RATE, IT WAS DETERMINED THAT THIS INFUSER HAD DEVELOPED A PROBLEM IN THE RATE CONTROLLER BETWEEN FINAL INSPECTION AND CUSTOMER USE, PROBABLY DUE TO SHIPPING AND HANDLING. ADD'L PROCESS CONTROL WAS IMPLEMENTED AND FINAL TESTING WAS PERFORMED AGAIN. ALL THE CUSTOMERS OF THE INFUSERS USED FOR CARDIAC STRESS TESTS WERE CONTACTED AND THE CUSTOMERS WERE REQUESTED TO RETURN THESE INFUSERS IMMEDIATELY TO CO FOR EVALUATION.
MALFUNCTIONING, DUAL CHAMBER PACEMAKER. LOSS OF ATRIAL SENSING, NEAR SYNCOPAL EPISODE. PT FELT WHEN HE MOVED AROUND, HE LOST CAPTURE. MONITORED SEVERAL EPISODES OF NON-PACED SINUS BRADYCARDIA AT 39 BEATS/MIN. ON 9/9/96, PT WAS DISCHARGED WITH FUNCTIONING PACEMAKER.
INVESTIGATION CONDUCTED. DR CITES SURGICAL TRAUMA AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY ANS SEVERITY THAT IS CONSIDERED USUSAL FOR THIS TYPE OF DEVICE.
THE PHYSICIAN HAD DIFFICULTY PASSING THE BALLOON INTO THE HUB OF THE INTRODUCER. THE PROFILE OF THE DEVICE WAS CHECKED AND NO OBVIOUS REASON COULD BE SEEN. THE DEVICE WAS EVENTUALLY PERSUADED INTO THE INTRODUCER HOWEVER, THE DEVICE DETACHED PREMATURELY, IT IS THOUGHT IN THE INTRODUCER.
TWO INTRODUCERS OF THE SAME BATCH WERE USED. THE PHYSICIAN HAD DIFFICULTY PASSING THE BALLOON INTO THE HUB OF THE INTRODUCER. THE PROFILE OF THE DEVICE WAS CHECKED AND NO OBVIOUS REASON COULD BE SEEN. THE DEVICE WAS EVENTUALLY PERSUADED INTO THE INTRODUCER, HOWEVER, THE DEVICE DETACHED PREMATURELY, IT IS THOUGHT IN THE INTRODUCER. AS THE PHYSICIAN WAS USING FLUSH THE BALLOON FLUSHED OUT OF THE INTRODUCER. THERE WAS NO CONSEQUENCE TO THE PT. DURING THE INVESTIGATION IT WAS OBSERVED THAT THE INTRODUCER CATHETER WAS BENT AT 5 CM DISTAL TO THE HUB AND ALSO KINKED 23 CM DISTAL TO THE HUB, HOWEVER THE GUIDE CATHETER WAS INSERTED AND REMOVED FROM THE INTRODUCER WITHOUT ANY DIFFICULTIES. THE INTRODUCER HUB WAS OBSERVED UNDER MAGNIFICATION, NO DEFECTS THAT COULD EXPLAIN THE RESISTANCE EXPERIENCED WITH THE DEVICE WERE OBSERVED. WITHOUT THE DEVICE USED IN THE PROCEDURE, IT IS NOT POSSIBLE TO DETERMINE WHY THE DEVICE FAILED. IT SHOULD BE NOTED HOWEVER, THAT ITC'S RECOMMENDATION TO REMOVE THE ENTIRE CATHETER SYSTEM WHEN RESISTANCE IS ENCOUNTERED, WAS NOT FOLLOWED. INSTEAD ATTEMPTS WERE MADE TO RETRIEVE ONLY THE DELIVERY CATHETER, THIS LIKELY CAUSED THE DEVICE TO DETACH FROM THE DELIVERY CATHETER AS IT WAS BEING PULLED BACK THROUGH THE INTRODUCER CATHETER. THIS INFO IS BASED ON INFO SUPPLIED TO CO   WITHOUT INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT.
THE BALLOON WOULD NOT INFLATE DURING PREP PROCEDURE.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAM: TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE BALLLON, INNER BODY AND HUB. THE BALLOON EXHIBITED A COMPLETE CIRCUMFERENTIALLY-DIRECTED TEAR, 3.0 CM PROXIMAL TO THE DISTAL TIP AND PULLED DISTALLY OVER ITS DISTAL TIP. MICROSCOPIC EXAMINATION: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING THE PROXIMAL TEAR EDGE, ALSO, MULTIPLE EXTERNAL SURFACE ABRASIONS INTERSECTING THE DISTAL TEAR SEGMENT EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON TEAR MIGRATING IN A CIRCULAR DIRECTION COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
THE END BROKE OFF BETWEEN THE THICK AND THIN PART OF THE CATHETER POSSIBLY WITH A TINY TWIST MOTION. NOTICED IMMEDIATELY AND REPLACED. NO INJURY TO PT.
INTERMITTENT PHACO CALIBRATION FAILURE DURING A CATARACT EXTRACTION PROCEDURE. SYSTEM COULD NOT BE RECALIBRATED AND THE PHYSICIAN PERFORMED AN EXTRACAP PROCEDURE. THE PROCEDURE WAS DELAYED APPROX 30 MINUTES.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT AS DEFINED IN THE REGULATIONS AS DEATH OR SERIUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF IT RECURS. THE SAMPLE WAS RETURNED WITH BALLOON COMPLETELY DETACHED AND MISSING. THE AREAS FROM WHICH THE BALLOON DETACHED WERE MICROSCOPICALLY EXAMINED AND NOTHING WAS FOUND THAT MAY HAVE CAUSED THE EVENT. THE ONLY TIME THIS EVENT HAS BEEN OBSERVED IN-PROCESS WAS DURING "FILL TO BURST" TESTING.
ACCOUNT REPORTED INCIDENT IN WHICH HEALTH CARE PROFESSIONAL STATED THAT "BLOOD TUBING HAD A SLIT IN IT AND WENT TO PRIME UNIT OF BLOOD AND HANG IT WHEN BLOOD NOTED TO BE COMING OUT OT THE TUBING AND ALL OVER THE PT." NO PT INJURY REPORTED.
SAMPLE NOT BEING DE-CONTAMINATED BY HOSPITAL FOR FURTHER EVALUATION. NO FURTHER INVESTIGATION IS POSSIBLE.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNKNOWN. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS-FROM BOX D6) MODEL/CATALOG#, 5508HL/5508HL, LOT NUMBER 950401.
DURING A CATARACT EXTRACTION PROCEDURE, THIS OPHTHALMIC MICROSURGICAL SYSTEM LOCKED UP AND RESET. ANOTHER SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THE BIOMED TECHNICIAN WAS ABLE TO GET THE UNIT TO RESET BUT WAS UNABLE TO GET THE UNIT TO LOCK UP.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. EVAL OF DEVICE IS ONGOING.
BALLOON RUPTURED WHEN ADVANCING THRU GUIDING CATHETER, NEVER WENT IN THE VESSEL.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT. VISUAL EXAM: TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE BALLOON AND INNER BODY. FUNCTIONAL TESTING: THE BALLOON WAS INFLATED WITH WATER USING AN INFLATION DEVICE, WHICH REVEALED THE PRESENCE OF 4 SEPARATE PINHOLE-TYPE LEAK SOURCES IN THE BALLOON, WITH 2 PINHOLES IN THE DISTAL TIP. MICROSCOPIC EXAM: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING THE PINHOLE TEAR EDGES OF THE 2 PINHOLES IN THE DISTAL PORTION OF THE BALLOON. THE 3RD AND 4TH PINHOLES IN THE MORE PROXIMAL PORTION OF THE BALLOON, ALONG WITH EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING THE PINHOLES' TEAR EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
VAGUE REPORT OF THE HOSP HAVING OCCURRENCES OF IV INFILTRATIONS THAT THEY FEEL ARE RELATED TO THE INFUSION PUMPS. NO SPECIFIC INFO WAS RECEIVED. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. INFILTRATION IS A COMPLICATION OF IV THERAPY. THE INFUSION PUMPS DO NOT HAVE INFILTRATION DETECTION CAPABILITIES. THE HEALTHCARE PROFESSIONAL HAS THE RESPONSIBILITY FOR FREQUENT INSPECTION OF THE IV SITE FOR SIGNS OF INFILTRATION.
DR CITES POST SURGICAL LOADING OF IMPLANT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PHYSICIAN REPORTS BLEEDING FROM A 2MM-3MM HOLE AT THE BIFURCATION OF A VASCULAR PROSTHESES DURING AN AORTO-BIFURCATION BYPASS PROCEDURE. THE HOLE WAS DISCOVERED WHILE THE AORTAL SECTION WAS BEING FLUSHED TO TEST THE PROXIMAL ANASTOMOSIS. THE GRAFT WAS RECLAMPED ABOVE THE LEGS AND THE HOLE REPAIRED WITH 3 SUTURES AND A TEFLON PLEDGET. ACCORDING TO THE SURGEON, THE PT EXPERIENCED NO UNTOWARD ADVERSE EFFECTS OR EXCESSIVE BLOOD LOSS AS A RESULT OF THE EVENT. THE PT LATER EXPERIENCED BLEEDING UNRELATED TO THE GRAFT AND WAS RETURNED TO SURGERY FOR A SECONDARY PROCEDURE. BECAUSE THE SURGICAL INTERVENTION WAS FOR REASONS OTHER THAN THE ALLEGED DEFECT, THE USER FACILITY DOES NOT CONSIDER THE EVENT TO BE A DEVICE RELATED SERIOUS INJURY.
H6-DEVICE HISTORY RECORDS WERE REVIEWED FOR SIMILAR DEFECTS. RECORDS SHOW ONE IN-PROCESS REJECT DUE TO A HOLE AT AN UNSPECIFIED LOCATION OF THE GRAFT. COMPLAINT HISTORY FOR DEVICE FAMILY SHOWS NO SIMILAR COMPLAINTS. BIFURCATED VASCULAR GRAFTS ARE WOVEN AS A SINGLE UNIT. DURING THE WEAVING PROCESS A SMALL HOLE IS LEFT AT THE POINT AT WHICH THE TRUNK SPLITS OFF INTO THE LEGS OF THE GRAFT. THE HOLE IS CLOSED BY MACHINE STITCHING. ALL DEVICES ARE 100% VISUALLY INSPECTED UNDER MAGNIFIED LIGHT. PRIOR TO THIS EVENT, ADDITIONAL MEASURES WERE IMPLEMENTED FOR THE INSPECTION OF BIFURCATED GRAFTS. BECAUSE THE GRAFT, IN THIS CASE, WAS UNAVAILABLE FOR INSPECTION, THE MFR WAS UNABLE TO DETERMINE WHETHER THE HOLE WAS THE RESULT OF A STITCHING DEFECT OR WAS CAUSED BY A CUT OR TEAR FROM HANDLING DURING PROCEDURE, ITSELF. THIS INCIDENT IS CONSIDERED TO BE AN ISOLATED EVENT. NOTE: ALL PT AND USER INFO (SECTIONS A,B, D,E, AND F) WERE COMPLETED BY INTERVASCULAR. A UF NUMBER HAS NOT BEEN ASSIGNED TO THE INCIDENT BECAUSE THE USER FACILITY DOES NOT CONSIDER THE EVENT TO BE A SERIOUS INJURY.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY MFR. DATE ENTERED IN SECTION F.13 IS THEDATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
IT WAS REPORTED THE APPLIER WAS USED DURING A LAPARASCOPIC CHOLECYSTECTOMY. THE CLIP WOULD NOT FIRE SRAIGHT, AND CLIP WOULD NOT STAY IN TISSUE. ANOTHER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. 8/16/96 REP REPORTS THE MALFORMED CLIPS WERE REMOVED.
CO #964266.CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICIAL CONDITION. THE INSTRUMENT WAS CYCLE, FED, AND FORMED THE CLIPS WITHIN DESIGN SPEC WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNKNOWN. THIS FILE IS CLOSED. TEH REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
WHILE PREPARING TO TAKE AN INTRAORAL X-RAY EXPOSURE WITH A X-RAY MACHINE THE SYSTEM OPERATOR STATED THAT THE UNIT WAS TURNED ON. THIS WAS VERIFIED BY THE SERVICE TECH WHO THEN TOOK THE UNIT OUT OF SERVICE UNTIL REPAIRED. THE UNIT WAS NOT POSITIONED SO THAT IT WOULD RADIATE THE OPERATOR OR PT.
DURING PHONE CALLS WITH THE DEALER SERVICE TECHNICIAN THE NECESSARY TROUBLE SHOOTING TECHNIQUES WERE APPLIED AND IT WAS DETERMINED THAT THE RELAY ON THE PRINTED CIRCUIT BOARD CAUSED THE ARO WHICH WAS SIGNIFIED BY AN AUDIBLE ALARM. THE UNIT WAS TAKEN OUT OF SERVICE UNTIL REPAIRED. THIS PRODUCT MALFUNCTIONED DID NOT CAUSE ANY SIGNIFICANT RADIATION TO BE RECEIVED BY THE PT. OR OPERATOR.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE STOPPED WORKING. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTION A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.3 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT CONSUMES ALCOHOL AND MAY BE A BRUXER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PIR REF NO CP960589. BASED ON INTERNAL TESTING OF DEVICE (PCS2) A POSITION BLOOD SWITCH ON A VALVE LOCATED ON THE RETURN LINE FAILED. THE FAILURE WAS DETERMINED TO BE ISOLATED TO THIS ONE COMPONENT AND WAS INTERMITTENT. THE SWITCH FAILURE ALLOWED THE SYSTEM TO BELIEVE THE VALVE WAS OPEN AND READY FOR BLOOD RETURN TO THE DONOR. HOWEVER THE VALVE REMAINED CLOSED AND THE BLOOD PUMP ROTATED ON A CLOSED LOOP OF BLOOD WHICH WILL CAUSE HEMOLYSIS. SOME OF THIS HEMOLYZED BLOOD PROBABLY WAS PUMPED PAST THE VALVE IN ORDER FOR THE DONOR TO HAVE EXPERIENCED SOME SYSTEMIC HEMOLYSIS PRESUMED BECAUSE OF THE NOTED URINE DISCOLORATION. DONOR IS FINE AND THE SWITCH PROBLEM WAS AN ISOLATED PROBLEM ACTUAL HEMOLYSIS COULD NOT BE DETERMINED BECAUSE THE BLOOD IN THE SET WAS NOT ANALYZED AND DONOR HAS REFUSED TO PERMIT BLOOD CTR TO ACCESS HOSP RECORDS.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAVH. THE DEVICE WAS FIRED. THE STAPLES WERE FORMED, BUT THE DEVICE DID NOT CUT. THE SURGEON USED SCISSORS TO COMPLETE THE CUT LINE. ANOTHER WAS OPENED TO COMPLETE THE CASE. NO BUTTRESSING MATERIAL WAS USED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,4;B3,6,7;D5,10;H4-INFORMATION NOT PROVIDED. H6-CODE 400 - DAMAGED FIRING MECHANISM. CONCLUSION: BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SAFETY SHIELD WOULD NOT RETRACT. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE FACILITY DETERMINED THE REPORT WAS THE RESULT OF OPERATOR ERROR, IN THAT THE ADAPTER WAS NOT FULLY LATCHED TO THE DEFIBRILLATOR AT THE TIME OF THE EVENT. THE ADAPTER IS LABELED WITH THE INSTRUCTION TO "ROTATE LEVER UP TO LOCK ADAPTER IN RECESS". THE PRODUCT OPERATING INSTRUCTIONS INSTRUCT THAT THE ADAPTER LEVER BE LOCKED INTO PLACE. THE TROUBLESHOOTING SECTION OF THE SAME INSTRUCTIONS DESCRIBE THAT THA ADAPTER BE CHECKED TO ASSURE IT IS LOCKED INTO PLACE. THE LOCAL CO SALES REP PROVIDED THE FACILITY STAFF WITH ADDITIONAL TRAINING IN DEVICE OPERATION. THE DEVICE WAS RETURNED TO USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
DEVICE CHARGED BUT WOULD NOT DISCHARGE DEFIBRILLATOR ENERGY TO A PT.
WHILE PERFORMING A SOFT SARCOMA PROCEDURE ON THE PT'S RIGHT INNER THIGH, IT WAS NOTED THAT THE ORANGE FREEZE CONTROL VALVE KNOB DID NOT SHUT OFF COMPLETELY. IN ORDER TO DISCONTINUE FREEZING OF THE PROBE, THE LIQUID NITROGEN IN THE DEWAR WAS VENTED. THERE WAS NO PT COMPLICATIONS.
ON 8/16/96 CONTACT PERSON CALLED THE CIN DIRECTLY AND STATED THE SURGEON HAD USED THE SKIN STAPLER TO AFFLIX MESH DURING A HERNIA REPAIR. APPROXIMATELY THREE HOURS POST-OP, THE PATIENT'S SCROTUM WAS ENLARGED AND THE PATIENT WAS RETURNED TO THE OR HOLDING AREA FOR OBSERVATION FOR QUESTIONABLE BLEEDING. THE PATIENT REPORTEDLY DID NOT REQUIRE ANY TREATMENT, HOWEVER, AND THE SWELLING RESOLVED. TSB 8/21/96  WAS ABLE TO TALK TO THE OR NURSE, REGARDING THIS CASE, DR ELECTED TO USE THE SKIN STAPLER FOR ATTACHMENT OF MESH DURING A HERNIA REPAIR, DESPITE THE FACT THAT HE WAS WELL THAT THIS WAS CONTRARY TO THE LABELING. 8/21/96 THE PATIENT SUSTAINED SOME BLEEDING POST OPERATIVELY AND WAS OBSERVED IN THE RECOVERY ROOM. REEXPLORATION WAS NOT CARRIED OUT. ATTEMPTED TO REACH DR AND HAVE NOT MADE CONTACT. 8/26/96 1535 SPOKE TO CONTACT IN SAFETY WHO REFERRED ME TO CONTACT IN BIO-MED. AND SHE SAID ANOTHER PERSON WILL CALL BACK. TKB
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT LOCKED ON TISSUE. THE INSTRUMENT WAS REMOVED MANUALLY. THE HOSPITAL REPORTED NO PT INJURY.
WHILE RUNNING AN HTLV-1 ASSAY, THE SAMPLE HANDLER, SERIAL NUMBER 1330, DID NOT PIPETTE ENOUGH SAMPLE IN POSITIONS 9A AND 9E AND DID NOT GENERATE AN ERROR MESSAGE. DISTRIBUTOR'S FIELD SVC ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO CO COMPLAINT NUMBER 96-04797-09.
DURING A VITRECTOMY PROCEDURE, THERE WAS NO INTRA-OCULAR PRESSURE GOING TO THE EYE. THE PNEUMATIC SUPPLY LINE TO THE UNIT WAS RECONNECTED AND THEN THERE WAS A BLAST OF AIR INTO THE EYE. THE PROCEUDRE WAS THEN COMPLETED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. REPORTED PROBLEM COULD NOT BE DUPLICATED. THERE MAY HAVE BEEN A CRIMP OR BLOCKAGE IN THE TUBING THAT WAS RELEASED WHEN THE AIR SUPPLY WAS RECONNECTED.
DISTRIBUTOR BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE PLACING AN IMPLANTABLE PORT. THE INTRODUCER SHEATH WAS PLACED, THE PEEL AWAY PORTION WAS PULLED BACK, HOWEVER, A PORTION CRACKED AND DETACHED LEAVING APPROX 2/3 OF THE EXTRUSION IN THE PT. ATTEMPTS TO REMOVE THE SHEATH SEGMENT FROM THE PLACEMENT SITE WERE UNSUCCESSFUL. SUCCESSFUL RETRIEVAL VIA THE FEMORAL VEIN FOLLOWED. ANOTHER PORT WAS PLACED SUCCESSFULLY AND THERE WERE NO PT COMPLICATIONS INVOLVED. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED.
THE PRODUCT WAS APPLIED DURING A FACE LIFT. REPORTEDLY, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THESE THREE TIPS HAVE VERY, VERY ROUGH ENDS WHICH CAN BE SEEN WHEN LOOKING AT THEM UNDER A MICROSCOPE. ALL OF THESE TIPS HAVE BEEN USED DURING PROCEDURES. ONE OF THESE TIPS WAS USED IN A PROCEDURE WHERE THE PHYSICIAN BROKE THE PT'S CAPSULE, BUT IT IS NOT KNOWN IF THIS TIP CAUSED THE BROKEN CAPSULE.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED THE EZ35W WAS CLOSED ON TISSUE, FIRED, AND WOULD NOT REOPEN. REP REPORTS NO OTHER INFO WAS AVAILABLE. THERE WAS NO CONSEQUENCE TO THE PT. REC'D MEDWATCH 8/27/96 "PRODUCT INSERTED AND POSITIONED ON TISSUE-MISFIRED STAPLES NOT LINED UP PROPERLY CUTTER DIDN'T WORK-PRODUCT REMOVED-ANOTHER STAPLER OPENED, INSERTED & WORKED PROPERLY-NO IMPACT ON OUTCOME".-
B6,7;D5,10;H4- INFORMATION NOT PROVIDED. BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT RE-OPEN" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS RETURNED WITH A CARTRIDGE THAT HAD THE MIDDLE ALIGNMENT FINGER AND LOCKOUT TAB BROKEN OFF. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
TISSUE EXPANDER WAS NOTED TO HAVE A HOLE IN IT.
THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION PROCEDURE. A LONGITUDINAL TEAR OF THE TISSUE PROXIMAL TO THE ANASTOMOSIS WAS REPORTED.  THE SURGEON MANUALLY SUTURED. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
X-TUBE ASSM 19" X 16" DEALER ALLEGES X-TUBE BROKE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO'S EMPLOYEES, ITS CONTACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. CAUSE FOR FRACTURE IS UNKNOWN. THIS FILE IS CLOSED UNTIL AND UNLESS FURTHER INFO IS RECEIVED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
ACCOUNT PERFORMING ANGIOPLASTY OF THE LEFT ATRIUM VIA A BYPASS GRAFT. WHEN ACCOUNT WENT TO SPREAD THE INCISION SITE WITH THE HEMOSTATS, A SHARP EDGE ON THE HEMOSTATS CUT THE INCISION AND PART OF THE GRAFT. ACCOUNT APPLIED PRESSURE TO THE SITE FOR APPROX 45 MINS TO STOP THE BLEEDING. NO OTHER MEDICAL TREATMENT WAS REQUIRED. ACCOUNT WAS ABLE TO CONTINUE ON WITH THE PROCEDURE.
SECTION F CORRECTION: ALL INFO SUPPLIED ON THE INITIAL REPORT SHOULD HAVE BEEN NA BECAUSE NO USER FACILITY MEDWATCH REPORT WAS RECEIVED. NOTE: FACILITY WAS CONTACTED AND ALL UNK INFO ON THE INITIAL REPORT IS STILL UNK WITH THE EXCEPTION OF THE ADDED INFO ON THIS SUPPLEMENTAL REPORT. RESULTS OF EVALUATION: CONCLUSION: A) IT WAS CONCLUDED THAT THE INST. HAD INCURRED CUTS IN THE BALLOON, MAKING THE INST. NON FUNCTIONAL. THE INST. WAS RECEIVED WITH 2 CUTS, 3/16 AND 1/64 OF AN INCH IN LENGTH, WHICH WERE APPROX. 110 DEGREES FROM THE STOPCOCK POSITION IN THE PROXIMAL PORTION OF THE BALLOON. THERE WERE ABRASION MARKS OBSERVED AT BOTH POINTS OF DAMAGE. B) IT WAS CONCLUDED THAT THE BALLOON HAD BURST, MAKING THE INST. NON FUNCTIONAL. THE POINT OF PROPAGATION WAS OBSERVED TO BE APPROX 140 DEGREES FROM THE STOPCOCK POSITION AND WAS IN THE PROXIMAL PORTION OF THE BALLOON. NO ABRASION MARKS WERE OBSERVED. C) NO CONCLUSION COULD BE REACHED A S TO WHY THE INST'S BALLOON "BROKE" DURING SURGERY. THE INST. WAS RECIEVED IN GOOD CONDITION AND WAS EXAMINED AND FOUND TO BE FUNCTIONAL. THE BALLOON WAS INSUFFLATED TO OVER 40 PUMPS REPEATEDLY, WITH THE HAND BULB PROVIDED, WITHOUT INCIDENT. COMMENTS: ABC)EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IF FUNCTIONS PROPERLY.
CLINICALLY FOLLOW UP: 8/29/96 1205 SURGEON CALLED BACK STATING HE EXPERIENCED DIFFICULTY WITH TWO TED 12 DEVICES DURING A LAPAROSCOPIC HERNIA PROCEDURE. THE SURGEON REPORTED HE MADE A 1 1/2 TO 2 CM INCISION AND BLUNTLY DISSECTED THE FASCIA WITH A KELLY INSTRUMENT AND HIS FINGER. THE SURGEON SAID NO RETRACTORS WERE USED AT THE TIME THE DEVICES WERE INSERTED. THE SURGEON REPORTED BOTH BALLOONS ON THE DEVICES WERE LUBRICATED WITH KY JELLY PRIOR TO INSERTION. THE SURGEON STATED THE PT DID NOT HAVE ANY ADHESIONS IN THE PLANE OF DISSECTION AND IT TOOK A VERY LOW AMOUNT OF FORCE TO TUNNEL WITH EACH OF THE DEVICES. THE SURGEON SAID THE SCOPE WAS USED DURING TUNNELING WITH BOTH TED 12 DEVICES. THE SURGEON REPORTED HE WAS UNSUCCESSFUL IN INFLATING EACH OF THE TED 12 DEVICES. THE SURGEON STATED HE A THIRD TED 12 WAS OPENED AND IT WORKED FINE. THE SURGEON REPORTED THERE WAS NO CONSEQUENCE TO THE PT. JCM
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE ANVIL DISENGAGED WHEN RELOADING THE DISPOSABLE LOADING UNIT OUTSIDE OF THE PT CAVITY.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT IS A SMOKER AND WAS ADDICTED TO MARIJUANA. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS-( FROM BOX D6). MODEL/CATALOG# 2312H/2312H, LOT NUMBER-89696.
X-TUBE ASSM 16" X 15" DEALER ALLEGES THE X-TUBE BROKE AT THE CTR BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO, DEOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE KNIFE BLADE DID NOT RETRACT WITHIN THE CARTRIDGE AFTER FIRING THE CARTRIDGE. HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
PT HAD REMOVAL OF BREAST IMPLANTS DUE TO CAPSULAR CONTRACTURE AND COMPLAINTS OF HARDNESS AND SENSATION OF TEARING AND PAIN IN LEFT BREAST. IMPLANTS WERE IN SUBGLANDULAR POSITION. THE RIGHT IMPLANT WAS FOUND INTACT AND WEIGHED 310 GMS WITH THE CAPSULE. THE LEFT IMPLANT WAS RUPTURED AND WEIGHED 245 GMS WITH THE CAPSULE. MICROSCOPIC EVALUATION OF CAPSULE TISSUE REVEALED FOREIGN BODY REACTION AND FIBROSIS OF SURROUNDING TISSUE. PT HAD SUBMUSCULAR SALINE BREAST IMPLANTS PLACED IN THE RIGHT AND LEFT BREASTS, FILLED WITH 450 CC AND 500 CC RESPECTIVELY.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL LOADING OF IMPLANT AND INFECTION AS CAUSE FOR FAILURE. PT IS A SMOKER, CONSUMES ALCOHOL AND HAS DIMINISHED ORAL HYGIENE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE CUTTER FAILED TO FIRE AFTER THE SECOND CARTRIDGE LOADING. THERE WAS NO CONSEQUENCE TO THE PT.
9/3/96 1015 SURGEON STATED AFTER THREE TO FIVE FIRINGS, THE INSTRUMENT DOES NOT CUT OR DOES NOT FIRE AT ALL. A1,2,3,4;B3,6,7;D5,10;H4 - INFORMATION NOT PROVIDED. CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "FAILED TO FIRE" DURING SURGERY. THE INSTRUMENT WAS RETURNED WITH A FULLY FIRED SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
X-TUBE ASSM 18" X 18" DEALER CLAIMS X-TUBE BROKE AT CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY INSUFFUCIENT AND SMOKING AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE WAS APPLIED DURING UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRED AND WAS DIFFICULT TO REMOVE FROM THE APPLICATION SITE. THE SURGEON MANUALLY MANIPULATED THE DEVICE OPEN WITHOUT PT INJURY. A NEW DEVICE WAS APPLIED TO COMPLETE THE PROCEDURE.
10/4/96-SUBMISSION OF SUPPLEMENTAL REPORT WITH ADD'L INFO IN SECTIONS D-7, D-8 AND D-9. EVALUATION INDICATED AND CODES ENTERED IN H-3 AND H-6.
REAR A/F DAB PNTD L. DEALER ALLEGES REAR SIDE FRAME BROKE.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITSS CONTRACT SVC FIRMS OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
EVENT DESCRIPTION: REPORT OF FIBER SEPARATION.
510K #950928 IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
DURING A CATARACT EXTRACTION PROCEDURE, THE FOOT PEDAL FOR THIS OPHTHALMIC MICROSURGICAL SYSTEM WOULD NOT RELEASE. ANOTHER FOOT PEDAL WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED THORACIC PROCEDURE. REPORTEDLY. THE ANVIL AND CARTRIDGE DISENGAGED. THE SURGEON RETRIEVED ALL COMPONENTS WITHOUT INCIDENT. A NEW DEVICE WAS APPLIED TO COMPLETE THE PROCEDURE.
11/11/96 - SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. ADDITIONAL DATA ENTERED IN D9.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNKNOWN. PT HAS CONGESTIVE HEART FAILURE AND CORONARY ARTERY DISEASE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS- (FROM BOX D6), MODEL/CATALOG#-3910HL/3910HL. LOT NUMBER-951410.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE STAPLES WOULD NOT LOCK. THE SURGEON APPLIED A NEW INSTRUMENT. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
INVESTIGATION CONDUCTED. CAUSE FOR FAILURE IS UNKNOWN. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS- (FROM BOX D6), MODEL/CATALOG# 3914HL/3914HL,4514HL/4514HL. LOT NUMBER-953850, 953556.
ASPIRATION FROM THIS OPHTHALMIC MICROSURGICAL SYSTEM WAS INTERMITTENT AND THE PHYSICIAN HAD TO STEP ON THE FOOT PEDAL SEVERAL TIMES BEFORE ASPIRATION WOULD ENGAGE. DURING A PROCEDURE, ASPIRATION SURGED AND THE PHYSICIAN DREW THE PT'S IRIS INTO THE HANDPIECE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. ALTHOUGH POST OPERATIVE RESULTS ARE ACCEPTABLE, THE PT WILL SUFFER THE COSMETIC EFFECTS OF A KEYHOLE PUPIL.
SECTIONS A THROUGH F OF THID MEDWATCH WAS COMPLETED BY THE MFR. THE DATE USED IN SECTION F.13 IS THE DATE THE REPORT WAS RECEIVED BY THE MFR. THE REPORTED PROBLEM COULD NOT BE DUPLICATED; HOWEVER, THE REPORTED PROBLEM WITH ASPIRATION MAY HAVE BEEN THE RESULT OF THE ASPIRATION RISE TIME SETTING. THE PHYSUISICAN REQUESTED ADD'L IN-SERVICE TRAINING. THE SYSTEM EXHIBITED CALIBRATION FAILURE DURING TESTING DUE TO A LOOSE POWER SUPPLY CONNECTOR. THE CONNECTOR WAS RESECURED.
THE DEVICE WAS USED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM. THE HOSPITAL REPORTED NO PT INJURY.
IT WAS REPORTED THE 511SD SAFETY SHIELD DID NOT RETRACT. SURGEON DID NOT NOTICE, BUT THE REP DID. AT THIS TIME HE IS STILL UNAWARE OF THIS AND USED THE TROCAR WITHOUT DIFFICULTY ONCE INSERTED. THE SEAL LEAKED THROUGH THE WHOLE CASE. NO TORQUEING OF THE INSTRUMENT WAS DONE. NO EXTRA MEASURES WERE TAKEN TO CONTROL THE LEAKING AND THE REDUCER WAS USED THROUGHOUT THE CASE.
D5; H4: INFO UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION. RESULTS OF EVALUATION: CONCLUSION; BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT'S "SAFETY SHIELD DID NOT RETRACT" DURING SURGERY. THE INSTRUMENT WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS EXAMINED AND WAS FOUND TO BE FUNCTIONAL AND WAS RE-ARMED AND CYCLED REPEATEDLY WITHOUT INCIDENT. THE SAFETY SHIELD WAS EXAMINED, TESTED AND FOUND TO FUNCTION AS DESIGNED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY.
DURING A CATARACT EXTRACTION PROCEDURE, THIS BIPOLAR CORD WOULD NOT WORK, ANOTHER CORD WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F OF THIS MEDWATCH WAS COMPLETED BY THE MFR. THE DATE USED IN SECTION F.13 IS THE DATE THE REPORT WAS RECEIVED BY THE MFR. THE CORD WAS VERY DARK IN COLOR AND THE OUTER COVER HAD A SMALL SPLIT IN IT. THIS IS AN OLD STYLE CORD.
A PHYSICIAN CHARGED THE DEVICE TO 200 JOULES DURING A PT COUNTERSHOCK ATTEMPT. PT DATA WAS NOT REPORTED. REPORTEDLY, THE PHYSICIAN RECEIVED A SHOCK FROM THE DEVICE DURING THIS ATTEMPT. THE PHYSICIAN BASED THIS ALLEGATION ON A FEELING OF BEING "PUSHED BACK FROM THE DEVICE" EITHER DURING DEFIBRILLATOR CHARGE OR DISCHARGE. THE FACILITY RISK MANAGER STATED THAT THE PHYSICIAN DID NOT REQUIRE MEDICAL TREATMENT AS A RESULT, AND THAT THE REPORT INVOLVED NO ADVERSE AFFECT TO THE PT.
IN AN EVAL OF THE DEVICE BY CO AND A THIRD PARTY BIOMEDICAL DEPT, PROPER OPERATION WAS OBSERVED THROUGH FULL FUNCTIONAL AND PERFORMANCE TESTING. AT CONCLUSION OF UNRELATED SERVICE BY THE FACTORY, THE DEVICE WILL BE RETURNED TO THE FACILITY FOR USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO PROVIDE ADD'L INFO ON THIS EVENT TO FDA.
IT WAS REPORTED THE DEVICE WAS USED DURING A ADHESIOLYSIS PROCEDURE. IT WAS REPORTED THE "SAFETY RESET BUTTON DID NOT ACTIVATE. IT RETURNED TO THE ORIGINAL POSITION". THERE WAS NO CONSEQUENCE TO THE PT.
F10: EVENT PRODUCT CODES; PT AND DEVICE WERE INCORRECTLY LABELED, AND SHOULD HAVE BEEN LABELED: {NA}.
UNABLE TO OBTAIN ALL INF REQUIRED IN SECTION F. TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL LOADING OF IMPLANT AND INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
X-TUBE ASSM 18" X 18" DEALER CLAIMS X-TUBE BROKEN AT WELD.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. DR CITES BONE QUALITY/QUANTITY INSUFFICIENT AS HEAVY SMOKER AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVRITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PATIENT IS DOING WELL. SURGEON STATED THE STAPLES WERE PRESENT IN THE TISSUE, BUT NOT COMPLETELY FORMED. PATIENT INFO: MALE, 143#, FIRST SUGERY FOR COLON CA, HX OF HTN. TSB D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
8/19/96 1601 MESSAGE AND 900# LEFT FOR MD CALL BACK. TSB 8/20/96 NNCL SENT TO MD. KJB 8/19/96 1621 THE CONTACT PERSON, WAS GONE FOR THE DAY. WAS ASKED TO CALL BACK TOMORROW. TSB 8/19/96 1628 CIN SPOKE WITH RISK MANAGER, SHE WAS UNAWARE OF THE REPORTED EVENT AND STATED SHE WOULD LOOK FURTHER FOR ADDITIONAL INFORMATION. TSB 8/20/96 1205 CIN SPOKE WITH CONTACT AND SHE STATED SHE DID NOT HAVE ACCESS TO THE INFORMATION NEEDED. SHE SUGGESTED CONTACTING THE SURGEONS OFFICE. BAH 8/20/96 1210 CIN SPOKE WITH THE SURGEONS OFFICE REQUESTING PATIENT INFORMATION. BAH 8/21/96 1105 DR CALLED BACK AND CONFIRMED THE INFORMATION AS REPORTED BY THE REP. HE STATED WHEN THE RESIDENT FIRED THE INSTRUMENT IT DID NOT FEEL RIGHT, IT DID NOT CLOSE ALL THE WAY, THE WASHER CRUNCH WAS NOT HEARD. WHEN THE INSTRUMENT WAS REMOVED, THE ANVIL WOULD NOT COME OUT AND IT HAD TO BE EXCISED. THE ANASTAMOSIS WAS THEN HAD SEWED.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS TEST RESULTS OUTSIDE MFR'S PLUS OR MINUS 10% RANGE FOR PRECISION TESTING. IMPRECISE RESULTS COULD, UNDER CERTAIN CONDITIONS HAVE ADVERSE CLINICAL EFFECTS. NO INJURIES REPORTED IN THE FIELD.
CLAIMANT WAS RE-USING THE ICE PARK, PACK WAS APPLIED TO THE SHOULDER FOR 15-20 MINUTES RESULTING IN COLD BLISTERS. DR PRESCRIBED A TOPICAL SOLUTION.
DOES THE MFR OR IMPORTER INTEND TO SUBMIT ADD'L INFO? NO. IS OCCURRENCE MORE FREQUENT OR OF GREATER SEVERITY THAN STATED IN DEVICE LABELING? NO PERTINENT STATEMENT IN LABELING. IS OCCURRENCE MORE FREEQUENT OR OF GREATER SEVERITY THAN USUAL FOR THE DEVICE? INFO NOT AVAILABLE.
AFTER THE PROCEDURE AND INCISION WAS MADE, A TOOTH WAS MISSING OFF OF A FORCEP.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS TEST RESULTS OUTSIDE MFR'S RECOMMENDED PLUS OR MINUS 10% RANGE. IMPRECISE RESULTS COULD, UNDER CERTAIN CONDITIONS HAVE ADVERSE CLINICAL RESULTS. NO INJURIES REPORTED IN THE FIELD.
BROACH HANDLE BROKE DURING USE. ALL PIECES WERE ACCOUNTED FOR.
UPON OPENING THE VIAL OF CEMENT MONOMER, THE VIAL BROKE CUTTING THE OR TECHNICIAN'S HAND. THE CUT DID NOT REQUIRE SUTURES. ANOTHER TECH WAS PRESENT DURING THE PROCEDURE AND COMPLETED THE CEMENT MIXING. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT UNDERGOING THE SURGERY OR THE OR TECH. THERE WAS ALSO NO DLEAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: EVALUATION RESULTS SUGGEST THAT THIS EVENT IS ATTRIBUTED TO IMPROPER TECHNIQUE BY THE USER. OPENING INSTRUCTIONS ARE PROVIDED BY THE MFR.
POST LATERAL FUSION WAS BEING PERFORMED. AN EXTRACTOR WAS BEING USED BY THE PHYSICIAN IN CASE. THE SCREW FELL OUT OF THE INSTRUMENT AND WAS FOUND.
QR AXLE W/SPACER. DEALER ALLEGES QR AXLE BEARING CAME OUT.
STAKING AT HOLE NOT SUFFICIENT OT RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO'S EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.
MFR RECALLED CUP INSERTS FOR A SUSPECTED SPECIFICATION VARIANCE. THE DEVICE HAS NOT BEEN SOLD OR MARKETED IN THE US SINCE 12/94. TWELVE (12) COMPONENTS EXISTED IN THE US AS FOLLOWS: 4 AT CO AND 8 AT A HOSP ON LONG TERM LOAN. ALL COMPONENTS WERE RECOVERED AND QUARANTINED AWAITING FURTHER INSTRUCTIONS FROM MFR. ALL DEVICES WILL BE DESTROYED FOLLOWING INSPECTION.
NONE RECALL COMPLETE. NO FURTHER PLANS TO MARKET DEVICE IN US.
ROUTINE COMPLAINT INVESTIGATION COMFIRMS TEST RESULT OUTSIDE MFR'S RECOMMENDED PLUS OR MINUS 10% RANGE FOR PRECISION TESTING. IMPRECISE RESULTS COULD, UNDER CERTAIN CONDITIONS HAVE ADVERSE CLINICAL RESULTS. NO INJURIES REPORTED IN THE FIELD.
THE BLISTER FOR THE STERILE SET SCREW IS EMPTY. THIS EVENT WAS NOTICED AT THE CO WAREHOUSE; THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
ADDITIONAL INFORMATION: IN MAY 1998, THIS EVENT WAS REEVALUATED FOR REPORTABILITY. IT WAS DISCOVERED THAT THE GAMMA SET SCREWS, THAT ARE MANUFACTURED IN KIEL, GERMANY, ARE PACKAGED, LABELED, AND STERILIZED UPON RECEIPT IN THE US. THEREFORE, THIS EVENT IS NOT LIKELY TO OCCUR IN THE US.
BALLOON LEAKS FREQUENTLY, MOSTLY AFTER 14 DAYS. PT GETTING NORMAL ENTERAL FEEDINGS IN BETWEEN SOME LIQUIDS.
200 & 68 PROBABLE CAUSE OF TEAR DUE TO OVERINFLATION OR HARSH ENVIRONMENT OF THE STOMACH.
DURING IMPACTION THE IMPACTOR HANDLE BROKE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE ROOT CAUSE OF CRACKING IS ATTRIBUTED TO A COMBINED EFFECT OF MECHANICAL, THERMAL AND CHEMICAL STRESS. THE SALES REP SHOULD INSTRUCT THE USERS THAT HIGHLY ACIDIC CLEANING SOLUTIONS SHOULD NOT BE USED TO CLEAN THE INSTRUMENTS.
X-TUBE ASSM 17" X 15". DEALER ALLEGES X-FRAME BROKE WHEN OPERATOR WAS CROSSING DOOR THRESHOLD.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVIC, CO'S EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EXPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS TEST RESULTS OUTSIDE MFR'S RECOMMENDED PLUS OR MINUS 10% RANGE FOR PRECISION TESTING. IMPRECISE RESULTS COULD, UNDER CERTAIN CONDITIONS HAVE ADVERSE CLINICAL EFFECTS. NO INJURIES REPORTED IN THE FIELD.
IT WAS REPORTED THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIP APPLIER WAS FIRED AND CLIPS CAME OUT OF JAWS UNFORMED. THEY WERE COMPLETELY OPENED AND CONTINUED TO FALL OUT. A COUPLE CLIPS DID FALL INTO THE ABDOMINAL CAVITY AND WERE RETRIEVED BY THE SURGEON LAPAROSCOPICALLY. THE FIRST CLIP FORMED OK, BUT NONE AFTER IT. THE CLIPS WERE BEING APPLIED TO THE CYSTIC DUCT WITHOUT TISSUE OR INSTRUMENTS OBSTRUCTING PLACEMENT. A NEW CLIP APPLIER WAS OPENED AND WORKED FINE. THERE WAS NO CONSEQUENCE TO THE PT.
CO #964313. 8/29/96 YEILDED JAWS. CONCLUSION: BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
ONE UNIT RETURNED TO CO FOR EVALUATION. EVALUATION OF THE RETURNED UNIT SHOWED THAT THE TUBING HAD BEEN CUT BY THE SLIDE CLAMP. THE SLIDE CLAMP WAS NOT RETURNED. LOT HISTORY REVIEW NOT AVAILABLE AS THE LOT NUMBER IS UNKNOWN TO THE CUSTOMER.
THE TIBIAL INSERT WOULD NOT FIT IN THE CORRESPONDING BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: EXAMINATION RESULTS INDICATE THAT THERE WAS SOME OBSTRUCTION TO BACKWARDS MOVEMENT OF THE INSERT IN THE BASEPLATE DURING ATTEMPTED ASSEMBLY WHICH CAUSED THE SNAP TAB TO CURL UP ON ITSELF.
A HOLE IN THE GRAFT'S CROTCH WAS FOUND DURING SURGERY AND APPROX 250-350ML OF BLOOD LEAKED FROM THE HOLE. THE BLEEDING STOPPED SPONTANEOUSLY AND THE GRAFT WAS LEFT IN. THE PT'S CINDITION IS REPORTED AS STABLE.
SINCE NO PRODUCT WILL BE RETURNED FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" HAVE NO INFO AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL -NO SIMILAR COMPLAINTS AGANST THIS BATCH.
X-TUBE 18" L W/RIVNUT BC. DEALER ALLEGES THE X-TUBE BROKE AT THE CENTER HOLE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA  OF THAT REPORT OF INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO'S EMPLOYEES, IT CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS SEVERAL TEST RESULTS WHICH WERE OUT-OF-RANGE OF THE QUALITY CONTROL SOLUTIONS (SPECIFICALLY INTENDED TO VERIFY DEVICE PERFORMANCE). THESE RESULTS, HAD THEY BEEN OBTAINED FROM A PT SAMPLE, COULD POTENTIALLY HAVE HAS ADVERSE CLINICAL EFFECTS. NO INJURIES REPORTED IN THE FIELD.
THE CO HAS HIGHLIGHTED OUT-OF-RANGE CONDITIONS IN THE USER MANUAL.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS WERE FALLING UNFORMED OUT OF THE APPLIER. THE CLIPS WERE BEING APPLIED TO THE CYSTIC DUCT WITHOUT TISSUE OR INSTRUMENT OBSTRUCTING PLACEMENT. A SECOND CUTTER WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. 8/20/96 IT WAS REPORTED THE SURGEON REMOVED THE CLIPS LAPAROSCOPICALLY.
8/20/96 1410 MD RESPONDED STATING CLIPS FELL OUT OF ER320 AND WERE RECOVERED. HE STATES THE PT WAS FEMALE, APPROXIMATE WEIGHT OF 170 POUNDS. HE WILL BE SEEING THE PT IN A FEW DAYS AND WILL TRY TO CALL US WITH ADDITIONAL INFO. D5,6:H3,4,6;G4: ADD ADDITIONAL INFO. A1,2;B6,7;D10:INFO NOT PROVIDED DURING INITIAL CONTACT. FOLLOW UP LETTER SENT TO FACILITY REQUESTING ADDITIONAL INFO. D6;INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE TIBIAL INSERT (LSJU) WOULD NOT SEAT IN THE BASEPLATE. THE SECOND INSERT, (AZ04), BROKE DURING POSITIONING ON THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
H4: MFG. DATE = AZ04- 3/00/90. LSJU- 10/00/95. AZ04: EVALUATION RESULTS INDICATE THAT THE SNAP TAB PROBABLY BROKE DURING ATTEMPTED ASSEMBLY WHILE BEING BENT OR DEFLECTED BACKWARDS. LSJU: THE INSERT COULD NOT BE SNAPPED INTO POSITION BECAUSE OF THE DEFORMED SNAP TAB. THE DAMAGE IS CONSISTENT WITH DOWNWARD FORCE BEING APPLIED TO THE INSERT BEFORE IT IS SUFFICIENTLY FAR BACK TO ENGAGECORRECTLY WITH THE POSTERIOR RETAINING FLANGES OF THE BASEPLATE.
THE GRAFT TURNED REDDER THAN USUAL AND LEAKED APPROX 30ML OF BLOOD (WITHIN LABEL SPECIFICATIONS). THE BLEEDING STOPPED SPONTANEOUSLY AND THE GRAFT WAS LEFT IN. ALTHOUGH THE DR STATED HE WAS NOT CONCERNED ABOUT THE LEAKAGE, HE BELIEVED THE GRAFT FELT THINNER THAN USUAL. THE PT WAS UNAFFECTED.
SINCE NO PRODUCT WILL BE RETURNED FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" HAVE NO INFO AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-NO SIMILAR COMPLAINTS AGAINST THIS BATCH.
THE TIBIAL INSERT WAS LOOSE DUE TO BREAKAGE OF THE SNAP FIT MECHANISM. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: FRACTURE OF THE SNAP TAB WAS CAUSED BY DOWNWARDS PRESSURE ON THE TOP SURFACE OF THE LATCH PORTION OF THE TAB. THE EVALUATION FURTHER SUGGESTS THAT SOME OBSTRUCTION TO BACKWARDS MOVEMENT OF THE INSERT IN THE BASEPLATE CAUSED DIFFICULTY IN ACHIEVING CORRECT ASSEMBLY.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS SEVERAL TEST RESULTS OUT-OF-RANGE WITH QUALITY CONTROL SOLUTION (USED TO VERIFY DEVICE PERFORMANCE). HAD THESE RESULTS BEEN OBTAINED FROM A PT SAMPLE, IT COULD HAVE HAD AN ADVERSE CLINICAL EFFECT. NO INJURIES REPORTED IN THE FIELD.
CATHETER WAS INSERTED ON 9/3/96. CHEMO WAS STARTED ON 9/6/96. ON 9/9/96, PT COMPLAINED OF LEFT ARM PAIN AND CHEST SWELLING. INJECTION OF CONTRAST INTO THE CATHETER REVEALED A SMALL AMOUNT OF EXTRAVASATION R TIP. TIP QUITE PROMINENT EXTRAVASATION. ON 9/9/96 THE CATHETER WAS REPLACED.
SINCE NO PRODUCT WILL BE RETURNED FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" HAVE NO INFO AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-NO SIMILAR COMPLAINTS AGAINST THIS BATCH.
SYRINGE DOES NOT WORK. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVAL: A VISUAL INSPECTION OF THE RETURNED ASSEMBLY INDICATED NO DISCREPANCIES. NONE OF THE COMPONENTS HAD BEEN USED. A FUNCITONAL CHECK INDICATED NO ANOMALIES. THE COMPLAINT COULD NOT BE VERIFIED. F1-14: HAS BEEN COMPLETED BY THE MFR. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
OR AXLE MAG Q/NUT. DEALER STATES THE BEARING CAME OUT OF THE AXLE.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA ON THAT REPORT OF INFO, DOES NOT REFLECT A CONCLUSION OR ADMISISON BY CO OR THE FDA THAT THE DEVICE, CO'S EMPLOYEES, ITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DATE SENT TO FDA: 10/11/96. CO WILL CONTINUE TO MONITOR TRENDS FOR THIS COMPLAINT CATEGORY. CO WILL PLACE ON THE LABEL THAT THIS PRODUCT IS FOR DENTAL USE ONLY.
PT. WITH CATHETER MONITORING. NOTED ALL FLUID GONE FROM IV BAG AND THIS LED TO PROBABLY AIR EMBOLUS. PT BECAME VERY DYSPNEIC AND REQUIRED INTUBATION AND VENTILATORY SUPPORT. SUSPECT DEFECT IN TRANSDUCER VALVE WHICH ALLOWED ALL FLUID TO INFUSE RAPIDLY.
THE HOSP REPORTED THE ENHANCEMENT CEMENT GUN, WAS DAMAGED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND WAS NOTICED PRE-OPERATIVELY. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR SURGICAL DELAY.
VISUAL INSPECTION REVEALED NO DISCREPANCIES. THE PRODUCT PERFORMED AS SPECIFIED. F1-14: HAS BEEN FILLED IN BY THE MFR. THIS IS CORRECTOED DATA NOT FILED ON ORIGINAL MEDWATCH FORM. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
TIP OF DEVICE REPORTED AS BROKEN DURING ARTHROSCOPIC SURGERY. BROKEN PIECE WAS RETRIEVED.
DEVICE EVAL REVEALED TIP OF DEVICE WAS WORN AND DULL. DEVICE WAS 9 YEARS OLD AND MAY HAVE NOT BEEN PROPERLY MAINTAINED. NO HOSP INCIDENT WAS FILED. CONTACT STATED A 5 MINUTE DELAY OCCURRED IN SURGERY TO REMOVE BROKEN PIECE. NO PT INJURY WAS REPORTED. CO DISCLAIMER: "SMITH AND NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH AND NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT".
THE DRIVER HEAD KEPT BECOMING LOOSE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME DUE TO THIS EVENT.
SUMMARY OF EVALUATION: THE COMPLAINT COULD NOT BE VERIFIED. NO DISCREPANCIES WERE OBSERVED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME. F1-14: HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY AND IS UNOBTAINABLE.
X-TUBE ASSM 18" X 16" DEALER CLAIMS X-TUBE BROKEN ON THE RIGHT SIDE OF CHAIR.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO'S EMPLOYEES ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE GRAFT TURNED REDDER THAN USUAL AND LEAKED APPROX 30ML OF BLOOD (WITHIN LABEL SPECIFICATIONS. THE BLEEDING STOPPED SPONTANEOUSLY AND THE GRAFT WAS LEFT IN. ALTHOUGH THE DR STATED HE WAS NOT CONCERNED ABOUT THE LEAKAGE, HE BELIEVED THE GRAFT FELT THINNER THAN USUAL. THE PT WAS UNAFFECTED.
SINCE NO PRODUCT WILL BE RETURNED FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" HAVE NO INFO AVAILABLE AT THIS TIME. SHOULD INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORD WERE NOT ATYPICAL -NO SIMILAR COMPLAINTS AGAINST THIS BATCH.
LEADS WERE REPLACED DUE TO NOISE. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORM TO SPEC. TO DATE 9/19/96 THE LEADS HAVE NOT BEEN RETURNED AND THERE WAS NO INDICATION WHETHER THE LEADS WERE EXPLANTED OR CAPPED.
THE INSERTER FOR THE HIP STEM BROKE WHILE IMPLANTING THE STEM. AN ALTERNATE PROSTHESIS AND INSERTER WERE USED TO COMPLETE THE SURGERY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: FAILURE ATTRIBUTED TO FATIGUE RESULTING FROM REPEATED RADIAL OVERLOAD CONDITIONS, 'SIDE IMPACTING'. DEVICE USED IMPROPERLY.
X-TUBE ASSM 17" X 16". DEALER ALLEGES X-TUBE BROKE AT THE BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE.
TIP OF DEVICE WAS REPORTED TO HAVE BROKEN.
DEVICE INVESTIGATION REVEALED EDM TIPS WERE BROKEN INDICATING DEVICE WAS NOT FULLY ENGAGED IN SCREW WHEN TORSIONAL FORCES WERE APPLIED. NO PT INCIDENT OR SURGICAL DELAY OCCURRED. CO DISCLAIMER: "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT".
AFTER USING THE #3 RASP AND 3.5 RASP THE #3 TRIAL BECAME LODGED IN THE CANAL. THE TRIAL WAS REMOVED AND THE STEM WAS IMPLANTED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT DUE TO THIS EVENT.
SUMMARY OF EVALUATION: THE RESULTS OF THE EVALUATION INDICATES THAT THIS EVENT WAS ATTRIBUTED TO LESS THAN OPTIMUM RASPING AND/OR REAMING OF THE FEMORAL CANAL.
SIX FR FOLEY INSERTED DURING TREATMENT OF SEPTIC SHOCK. CATHETER TAPED TO LEG AND WHEN CHILD MOVED, THE CATHETER SNAPPED APART ON THE JUNCTION NARROW LUMEN AND WIDENED AREA FOR URIMETER CONNECTION. SINCE FOLEY WAS TAPED, THERE WAS NO MIGRATION OF CATHETER TO BLADDER. BALLOON DID NOT DEFLATE. NO INJURY TO PT.
CUISTOMER ALLEGED THE AUDIBLE ALARM TO BE MALFUNCTIONING. THE CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE REPORTED CONDITION. THE CSE INSPECTED THE DEVICE AND REPOLACED THE FRONT PLANEL DISPLAY PRINTED CIRCUIT BOARD. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY THAN IS USUAL FOR THE DEVICE.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS TEST RESULTS OUTSIDE PLUS OR MINUS 10% RANGE RECOMMENDED BY MFR FOR PRECISION TESTING. UNDER CERTAIN CONDITIONS THESE RESULTS COULD HAVE ADVERSE CLINICAL EFFECTS. NO INJURIES REPORTED IN THE FIELD.
ALLEGEDLY POST OP X-RAYS AT ORIGINAL SURGERY SHOWED INSERT IN PLACE BUT 6 WKS POST OP X-RAY ALLEGEDLY SHOW INSERT IS NOT SEATED. PT WAS SYMPTOM FREE. PHYSICIAN WILL RECHECK IN 5 WEEKS AND FURTHER EVALUATE AT THAT TIME.
EVAL SUMMARY: UNABLE TO CONCLUDE CAUSE FOR REPORT AS DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND FOUND TO BE COMPLETE, ACCURATE, AND ACCEPTABLE.
CASTER ASSM W/HDWR P2 (EA). A BOLT CAME LOOSE AND CAUSED THE CASTER TO FOLD UNDER THE CHAIR.
ISOLATED OCCURRENCE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO'S EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ICU NURSE RECEIVED NEEDLESTICK WHEN NEEDLE/SYRINGE REPORTEDLY TUMBLED FROM CONTAINER.
METHODS: ON-SITE VISIT COMPLETED 8/9/96. LOT SPECIFIC INFO NOT AVAILABLE FROM FACILITY. RESULTS/CONCLUSIONS: REPORTED EVENT NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE DEVICE WAS APPLIED DURING AN OPEN CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS EJECTED FROM THE INSTRUMENT PREMATURELY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/30/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
THE DEVICE WAS NOT CLINICALLY APPLIED. THE HOSP HAS REPORTED THE SCOPE'S VISIBILITY WAS NOT CLEAR.
THE CUSTOMER REPORTED INACCURATELY HIGH BLOOD GLUCOSE READINGS WITH ANOTHER BRAND TEST STRIPS, LOT# 16121A. SHE ALSO REPORTED THAT A NORMAL CONTROL SOLUTION TEST RESULT WAS OUT OF THE NORMAL CONTROL SOLUTION RANGE. SHE OPENED THE BOTTLE ON 8/18/96 AND PERFORMED A BLOOD GLUCOSE TEST. THE RESULT WAS 250MG/DL. SHE STATED THAT HER BLOOD GLUCOSE LEVEL IS NOT USUALLY OVER 200MG/DL WITH ANOTHER BRAND TEST STRIPS. SHE IMMEDIATELY PERFORMED A TEST WITH ANOTHER BRAND TEST STRIP AND THE RESULT WAS 176MG/DL. A NORMAL CONTROL SOLUTION RESULT WAS 89 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 112-168MG/DL. THE NORMAL CONTROL SOLUTION WAS OPENED FOR THE FIRST TIME APPROXIMATELY ONE MONTH AGO AND THE CUSTOMER SHOOK IT WELL BEFORE TESTING. THE CODE WAS SET CORRECTLY FOR ALL TESTS, BOTH BRANDS OF TEST STRIPS ARE CODE8. THE DESICCANT IS IN THE BOTTLE OF STRIPS. THE CUSTOMER DOES NOT KNOW HER LAST HEMOGLOBIN A1C RESULT. THE CUSTOMER WAS UNWILLING TO PERFORM ANY TESTS WITH THE CO REPRESENTATIVE.
ERROR GRID ANALYSIS INDICATES THAT CUSTOMER'S TEST STRIPS MAY PRODUCE RESULTS WHICH FALL IN ZONE B, AND DO NOT REPRESENT A REASONABLE RISK OF SERIOUS INJURY. THE RETENTION SAMPLE TEST RESULTS ON 8/21/96 MET THE SPECS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS WERE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE EVAL OF RETENTION SAMPLES AND TREND ANALYSIS, THE PROBABILITY THAT THIS WAS A PRODUCT MALFUNCTION IS LOW, AND THAT IT IS UNLIKELY TO RECUR. CO REQUESTED THAT THE PRODUCT BE RETURNED FOR EVAL ON 8/19/96. CO WILL FORWARD A FOLLOW-UP TO THIS REPORT UPON RECEIPT OF RETURN TEST STRIPS AND THEIR EVAL. TIME FRAME IS UNK. QUESTION: IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? N. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? N. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N. SUBMISSION OF THE MDR DOES NOT CONSTITUTE AN ADMOISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS SEVERAL TEST RESULTS OUTSIDE MFR'S RECOMMENDED RANGE FOR PRECISION TESTING (PLUS OR MINUS 10%). UNDER CERTAIN CONDITIONS THIS COULD RESULT IN ADVERSE CLINICAL EFFECTS. NO INJURIES REPORTED.
86-DEVICE RETURN NOT EXPECTED. 100-TREND ANALYSIS PERFORMED ON BATCH LOT IN QUESTION. 68-TREND ANALYSIS DOES NOT EXCEED ALERT LEVELS.
DURING PT USE, THE DEVICE WAS SET-UP TO DELIVER LIPIDS FROM ANOTHER CO'S 20CC SYRINGE AT A RATE OF 0.6 ML/HOUR. THE HEAD NURSE INDICATED THAT THE DEVICE ACTUALLY DELIVERED 6.0 ML. THERE WAS NO PT INJURY.
THE EVAL OF THIS DEVICE IS NOW COMPLETE.
DURING A PLANNED MAINTENANCE VIST, CO SVC REPRESENTATIVE NOTED OUTPUT OF VAPORIZER WAS NOT WITHIN SPEC. THERE WAS NO REPORTED PT INJURY. THE UNIT WAS FORWARDED TO CO VAPORIZER SVC CTR. THE VAPORIZER WAS TESTED AND THE OUTPUT WAS FOUND TO BE LOW TO MFR'S SPECS. THE UNIT WAS DISASSEMBLED AND CORROSION WAS NOTED BETWEEN THE ROTARY VALVE ANBD SUMP COVER. CAUSE OF THE CORROSION COULD NOT BE DETERMINED. INITIAL REPORT FROM THE FIELD 9/22/96. CONFIRMATION OF REPORTABLE EVENT 9/5/96.
THE DEVICE WAS APPLIED TO THE CYSTIC DUCT AND ARTERY. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE PEEP PRESSURE IS FLUCTUATING. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED CONDITION. AS A PRECAUTION, THE CSE REMOVED AND REPLACED THE AUTOZERO SOLENOIDS. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
A PHYSICIAN REPORTED A PT WHO WAS TREATED ON 9/10/96 IN THE GLABELLA AND NASOLABIAL FOLDS. DURING TREATMENT TO THE RIGHT NASOLABIAL FOLD, THE PHYSICIAN OBSERVED THAT THE NEEDLE HAD "DISENGAGED" FROM THE SYRINGE; COLLAGEN MATERIAL SPLATTERED ONTO THE PT'S CLOTHING. TREATMENT WAS DISCONTINUED, AND RESUMED WITH ANOTHER SYRINGE. NO INJURY OCCURRED TO THE PT. THIS EVENT IS BEING REPORTED AS AN MDR BECAUSE IT COULD RESULT IN A SERIOUS INJURY IF IT WERE TO RECUR.
DEV. #1 PROB CODE: 1591 - NOT LABELED.  DEV. #2 PROB CODE: 1415 - NOT LABELED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORETDLY, THE INSTRUMENT JAMMED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
TRACH CUFF RUPTURED WHILE IT WAS BEING PLACED DURING A TRACHEOSTOMY PROCEDURE, IT WAS REPORTED THAT THE HOSP STAFF THINKS CARTILAGE MAY HAVE PIERCED THE CUFF. NO PT INJURY OCCURRED; A NEW DEVICE WAS USED WITHOUT FURTHER INCIDENT.
PCR#96-222-01. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING?N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT?N. IS THE EVENT SEVERITY ADDRESS IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THA USUAL FOR PRODUCT? N. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CCONSTITUTE AN ADMISSION THAT ANOTHER CO'S DEVICE IS DEVECTIVE OR HAS MALFUNCTIONED OR THAT A CO DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY
THE CUSTOMER REPORTED INACCURATELY LOW READINGS WITH TEST STRIPS. ON 8/18/96 HE OPENED THE FIRST BOTTLE FROM A BOX OF FIFTY AND OBTAINED A MORNING (FASTING) BLOOD GLUCOSE RESULT OF 35 MG/DL. BECAUSE HE FELT THE RESULT WAS NOT ACCURATE, HE PERFORMED A SECOND BLOOD GLUCOSE TEST. THE RESULT WAS 69 MG/DL. ON 8/19/96 HE CALLED THE CO CUSTOMER SUPPORT LINE AND EXPLAINED TO THE REP THAT HIS BLOOD GLUCOSE READINGS ARE USUALLY 130 TO 150 MG/DL. THE CUSTOMER WAS OUT OF NORMAL CONTROL SOLUTION SO HE WAS UNABLE TO PERFORM A CONTROL SOLUTION TEST. A CHECK STRIP TEST WAS PERFORMED WITH THE REP, WITH A RESULT OF 87 VERSUS A RANGE OF 72-96. THE DESICCANT IS IN THE OPEN BOTTLE.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 9/13/96. TWO BOTTLES, ONE OPENED CONTAINING 17 STRIPS WITH DESICCANT AND ONE UNOPENED CONTAINING 25 STRIPS WITH DESICCANT, WERE RETURNED TO CO FOR EVAL. THE TEST RESULTS OF THE UNOPENED BOTTLE MET THE SPEC FOR BLOOD GLUCOSE ACCURACY, AND DID NOT CONFIRM THE COMPLAINT OF LOW BLOOD GLUCOSE READINGS. THE TEST RESULTS OF THE OPENED BOTTLE FELL BELOW THE SPEC FOR BLOOD GLUCOSE ACCURACY, AND CONFIRMED THE COMPLAINT OF LOW BLOOD GLUCOSE READINGS. FURTHER EVAL OF THE DESICCANT INSIDE THE RETURNED OPENED BOTTLE INDICATES THAT THE LOW BLOOD GLUCOSE READINGS MAY BE DUE TO EXPOSURE TO MOISTURE. THE SOURCE OF MOISTURE EXPOSURE IS UNK. THE RETENTION SAMPLE TEST RESULTS FOR LOT 1K522B CONTINUE TO PROVIDE ACCEPTABLE PERFORMANCE INDICATING NO TREND OF PRODUCT DEGRADATION. BASED ON THE EVAL OF THE RETURNED UNOPENED BOTTLE, RETENTION SAMPLE TEST RESULTS AND TREND ANALYSIS, THE PROBABILITY THAT THIS WAS A PRODUCT MALFUNCTION IS LOW AND THAT IT IS UNLIKELY TO RECUR.  QUESTION: IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? N. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? N. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N. SUBMISSION OF THE MDR DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
DEVICE WAS REMOVED FROM THE PT DUE TO EROSION.
PUMP PERFORMED WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS, RECURRING INCONTINENCE, AND THE BALLOON HAD A CREAMY SEDIMENT INSIDE.
PUMP WAS NOT FUNCTIONALLY TESTED. CUFF HAD A WEAR LEAK. BALLOON HAD OR DAMAGE.
DEVICE WAS REMOVED FROM THE PT DUE TO EROSION, RECURRING INCONTINENCE, AND INFECTION.
PUMP RESISTOR FLOW RATE NOT WITHIN SPECS. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS.
THE DEVICE WAS REMOVED FROM THE PT DUE TO A SCROTAL ABCESS.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS.
THE CUFF WAS REMOVED FROM THE PT DUE TO EROSION-BLADDER NECK.
ON 9/19/91 AN AUS DEVICE WAS IMPLANTED. ON 1/25/96 THE BALLOON WAS REVISED. ON 6/18/96 THE CUFF AND PUMP WERE REVISED. ON 7/31/96 THE CONNECTORS WERE REVISED DUE TO AIR IN THE PUMP.
THE DEVICE WAS APPLIED DURING A BLADDER SUSPENSION. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/30/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT. CO'S EVALUATION FOUND THE DISPOSABLE LOADING UNITS WERE RETURNED WITH SIGNIFICANT HEAT DAMAGE PREVENTING A PROPER AND FULL EVALUATION OF THE UNITS. THE HEAT DAMAGE IS ATTRIBUTED TO AUTOCLAVING OF THE UNITS PRIOR TO THEIR RETURN TO THE MFR.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. REPORTEDLY, TWO COMPONENTS DISENGAGED FROM THE DISPOSABLE LOADING UNIT. THE SURGEON WAS UNABLE TO LOCATE THE COMPONENTS. THE HOSP HAS REPORTED THE PT'S STATUS IS SATISFACTORY.
9/30/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION.
A REVISION SURGERY WAS PERFORMED DUE TO INFECTION, EROSION, AND DISLOCATION OF LEFT CYLINDER. NO COMPONENTS WERE REMOVED OR REPLACED.
ON 12/12/88 DEVICE WAS IMPLANTED. ON 11/12/91 A CONNECTOR WAS REVISED. ON 4/7/92 A SINGLE CYLINDER, PUMP AND RESERVOIR WERE REVISED. ON 8/21/96 THE DEVICE WAS REMOVED FROM THE PT DUE TO CHRONIC PAIN.
INFORMATION RECEIVED ON 2/10/97 INDICATES A TANDEM CUFF PLACEMENT. NO COMPONENTS WERE REMOVED OR REPLACED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/30/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT. DUE TO A CLERICAL ERROR, THE STATUTORY MDR FILING DATE WAS MISSED.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE END OF A CYLINDER BROKE.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO TUBING EROSION, INFECTION, AND PAIN.
THE PRODUCT WAS APPLIED DURING A BOWEL ANASTOMOSIS. REPORTEDLY, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
1/22/97 - SUPPLEMENTAL REPORT #2 SENT TO FDA. ADDITIONAL INFORMATION ENTER IN D6.
IT HAS BEEN REPORTED TO CO THAT DURING PREP THE BALLOON OF THIS DEVICE RUPTURED. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO MIDSHAFT/GLANS PAIN, SEVERE DEFORMITY, AND PUMP INACCESSABLE.
PUMP PERFOMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
WHEN DILATING INSIDE A PREVIOUSLY PLACED STENT, THE CATHETER BALLOON RUPTURED AT 4-6 ATM. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE AND IT ALSO RUPTURED AT 4-6 ATM. REMOVAL AND REPLACEMENT WITH A COMPETITOR'S MODEL WAS SUCCESSFUL IN COMPLETING THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS.
BLOCK H6: METHOD CODE 86 ASSIGNED AS NO SAMPLE WAS AVAILABLE FOR EVALUATION CONCLUSION CODE 68 ASSIGNED AS THE ITEM WAS BEING USED AGAINST ITS LABELED INDICATIONS.
THE PRODUCT WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/30/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT. DUE TO A CLERICAL ERROR, THE MDR STATUTORY FILING DATE WAS MISSED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO URETHRAL EROSION. ADDITIONAL INFO RECEIVED ON 8/3/1998 INDICATES ONLY THE PUMP AND CYLINDERS REMOVED FROM THE PT, THE RESERVOIR WAS LEFT IN PLACE.
IT HAS BEEN REPORTED TO CO THAT DURING A DIAGNOSTIC PROCEDURE THE HUB OF THE DEVICE SEPARATED FROM THE SHEATH. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
DEVICE WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE AND REPLACED.
PUMP WAS FUNCITONAL. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS.
THE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION OF DISTAL TIP OF RUPTURE OF OUTER SHEATH. DACRON ADHERED TO PT'S TISSUE.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT DUE TO EROSION.
THIS ENTIRE FORM COMPLETED BY MFR. DEVICE DAMAGED DUE TO IMPLANT/EXPLANT PROCEDURE. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES NO J STIFFENER WIRE FRACTURES. THE J STIFFNER WIRE MEASURES APPROX 88MM WITH NO FRACTURES OBSERVED. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE LEAD WAS SNIPPED OR CUT APPROX 16CM DISTAL OF PROXIMAL TERMINAL PIN, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF BOTH PORTIONS OF LEAD RECEIVED INDICATES NO COIL WIRE DISCREPANCIES ON THE PROXIMAL SECTION AND CONFIRMS NO J STIFFENER WIRE FRACTURES.
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D7, D9 AND D9.  DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO URETHRAL EROSION.
IT HAS BEEN REPORTED TO CO THAT DURING PREP FOREIGN MATTER WAS NOTED IN THE LUMEN OF THIS DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE IS NOT BEING RETURNED FOR CO'S ANALYSIS.
THE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS PENILE SHAFT.
PUMP HAD A FATIGUE LEAK. RESERVOIR PERFOMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--LEFT CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A BULGE LEAK.
DURING A CROSSOVER DILATATION PROCEDURE, THE GUIDEWIRE EXITED THROUGH THE CATHETER SHAFT AND INTO THE PT'S AORTA. THE CATHETER HAD BEEN PLACED OVER THE BIFURCATE AREA & THE WIRE WAS EXCHANGED FOR RELOCATION. WHEN THE TIP OF THE WIRE REACHED THE BIFURCATION, THE CATHETER KINKED & THE WIRE CAME THROUGH. BOTH ITEMS WERE REPLACED TO COMPLETE THE PROCEDURE.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE DR DID NOT FEEL IT WAS HOLDING PRESSURE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO MALFUNCTION; PT NO LONGER WANTED.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD OR DAMAGE. CYLINDER HAD OR DAMAGE. CYLINDER HAD OR DAMAGE. TUBING HAD OR DAMAGE.
PARTICULATE WAS SEEN IN THE EYE OF A PT WHILE USING THIS PHACOEMULSIFICATION HANDPIECE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. NO PRODUCT WAS RETURNED FOR EVALUATION.
A LAPAROSCOPIC NEEDLE HOLDER WAS BEING CLEANED WHEN A COMPONENT OF THE GRASPING JAW WAS NOTED TO BE MISSING. THE DEVICE WAS LAST USED IN A LAPAROSCOPY-ASSISTED VAGINAL HYSTERECTOMY. THE FRAGMENT, APPROX 3.8 MM X 7.1 MM IN SIZE, MAY HAVE BEEN LOST IN THE PT, BUT NO EVIDENCE HAS BEEN FOUND TO DATE. USER FACILITY BELIEVES THE PIECE WAS POSSIBLY LOST DURING THE CLEANING AND HANDLING PROCESS.
DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION AT SCROTUM.
DEVICE WAS IMPLANTED ON 2/20/90. THE CYLINDERS WERE REVISED ON 7/23/93. THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS ON 9/3/96 AND REPLACED.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. FAILURE ANALYSIS INDICATES THAT LEAD IS FRACTURED WITHOUT PROTRUSION.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE STIFFNER WIRE HAS FRACTURED APPROX 30MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFNER WIRE MEASURES APPROX 57MM AND HAS MIGRATED DOWN LEAD BODY APPROX 37MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE LENGTH OF THE J STIFFNER WIRE WAS RECEIVED WITH RECORDED MEASUREMENTS ADDING UP TO APPROX 87MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURES.
A FACILITY REPORTED THAT SHORTLY AFTER INITIATION OF A TREATMENT, A BLOOD ALARM OCCURRED. THE MACHINE RESPONDED WITH A VISUAL AND AUDIBLE ALARM, AND THE BLOOD PUMP STOPPED. THE VENOUS LINE OCCLUDING CLAMP DID NOT CLOSE AS EXPECTED. THE MACHINE HAD PASSED THE PRETREATMENT ALARM TESTS. NO AIR ENTERED THE EXTRACORPOREAL CIRCUIT. THERE WAS NO BLOOD LOSS AND NO PT INJURY. THE TREATMENT WAS DISCONTINUED AND BLOOD RECIRCULATED. THE LEVEL DETECTOR MODULE WAS REPLACED AND PROPER MACHINE OPERATION VERIFIED. THE TREATMENT WAS RESTARTED AND COMPLETED WITHOUT INCIDENT.
EVAL OF THE RETURNED MODULE IS IN PROGRESS. THIS MODULE WAS MADE BY ANOTHER MFR.
DEVICE WAS IMPLANTED ON 10/27/92. THE RIGHT CYLINDER WAS REVISED ON 12/5/95. THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO FLUID LOSS ON 9/3/96 AND REPLACED.
INFO RECEIVED ON 11/11/96 INDICATES NO COMPONENTS WERE REMOVED OR REPLACED AT THE SURGERY.
THE VITRECTOMY VALVE FOR THIS OPHTHALMIC MICROSURGICAL UNIT WOULD NOT PULSE DURING A VITRECTOMY PROCEDURE. THE CUTTER WAS OPERATED AT THE FASTEST AND THE SLOWEST SETTINGS WHICH FREED THE CUTTER AND THE CASE WAS THEN COMPLETED. THERE WAS NO PT INJURY; HOWEVER, THE CASE WAS PROLONGED WHICH REQUIRED PROLONGED ANESTHESIA TO THE PT.
THE CYLINDERS WERE REMOVED FROM THE PT DUE TO RUPTURED CYLINDERS. UNABLE TO OBTAIN ADD'L INFO.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK.
THE RESERVOIR WAS REMOVED FROM THE PT DUE TO INFECTION.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCITONAL.
IN THE COURSE OF A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AN ELECTRODE CONNECTING CABLE SPARKED. THE HEAT BURNED INTO A SURGICAL DRAPE, BUT NO INJURIES OCCURRED.
DATA IN SECTION 7 WAS FILLED IN BY THIS MFR. THE WIRES HAVE BURNED THROUGH THE INSULATION OF THE DEVICE CAUSING A SEPARATION AT THE END WHERE THE ELECTRODE ATTACHES. SOME OF THE SMALL INTERNAL WIRES BECAME BROKEN AND SHORTED ELECTRICALLY WHEN POWER WAS APPLIED, CAUSING A BURN THROUGH THE INSULATION. OPERATING ROOM PERSONNEL PULL ON THE WIRE, INSTEAD OF GRASPING THE CONNECTOR WHEN REMOVING CABLE FROM THE ELECTRODE HANDPIECE.
THERE WAS NO ASPIRATION FROM THIS OPHTHALMIC MICROSURGICAL UNIT DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER UNIT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F OF THIS MEDWATCH WAS COMPLETED BY THE MFR. THE DATE USED IN SECTION F 13 IS THE DATE THE REPORT WAS RECEIVED BY THE MFR.
DEVICE WAS REMOVED FROM THE PT DUE TO PAIN AND DISCOMFORT.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO ANEURYSMAL DILATATION OF THE LEFT CYLINDER.
ADDITIONAL INFO RECEIVED ON 12/11/96 INDICATED THE REASON FOR REMOVAL WAS PAIN--CYLINDERS WERE TOO LONG.
ON 3/9/83 DEVICE WAS IMPLANTED. THE ENTIRE DEVICE WAS REPLACED, DATE NOT INDICATED. ON 6/19/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--RIGHT CYLINDER.
ON 7/12/90 AN AUS DEVICE WAS IMPLANTED (FIRST STAGE). ON 1/23/91 THE SECOND STAGE WAS PERFORMED ON AN AUS DEVICE. ON 8/29/96 THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
DURING A PHACOEMULSIFICATION/VITRECTOMY/FRAGMENTATION PROCEDURE, THUS INSTRUMENT WOULD NOT COAGULATE.
THE TIPS OF THIS BIPOLAR COAGULATOR WERE FOUND TO BE DAMAGED FROM ELECTRICITY AS THE INSULATION WAS MELTED. CAUSE FOR THE DAMAGE HAS BEEN DETERMINED TO BE CAUSED FROM IMPROPER HANDLING.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO A STUCK VALVE ON PUMP.
DEVICE WAS REMOVED FROM THE PT AND REPLACED. CORPUS CAVERNOSUM ONLY REASON GIVEN.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION.
THIS ENTIRE FORM COMPLETED BY MFR. UNABLE TO PERFORM ANALYSIS, ELECTRODE PARTIALLY RETURNED. LEAD RECEIVED IN A PARTIAL PROXIMAL APPROX 5CM PORTION WITH NO COIL WIRE FRACTURES OBSERVED AND NO PORTION OF THE J STIFFENER WIRE RECEIVED. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES LEAD WAS SNIPPED OR CUT APPROX 5CM DISTAL OF PROXIMAL TERMINAL PIN, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS NO COIL WIRE FRACTURES.
ON 8/2/90 DEVICE WAS IMPLANTED. ON 7/30/96 THE CYLINDERS WERE REVISED. ON 8/29/96 THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO SCROTAL INFECTION.
WHEN PLACING THE TIPS IN THE PENCIL SOMETIMES THERE WOULD BE A LITTLE SHOCK, THEN APPROX ON 8/12, THE PENCIL WAS LAYED DOWN ON THE TABLE AND SPARKS CAME OUT OF THE TIP END. THERE WAS NO PT INJURY.
INVESTIGATION OF THE ABOVE REFERENCED COMPLAINT HAS BEEN COMPLETED. THE ORIGINAL COMPLAINT STATING THAT "PENCIL WAS SHOCKING PEOPLE. LAID PENCIL DOWN ON TABLE AND SPARKS WERE COMING OUT OF TIP END. NO PT INJURY" WAS REC'D 8/15/96, AND THE TWO DEVICES RETURNED FOR EVAL 8/20/96. A MALFUNCTION MDR REPORT WITH THE FDA WAS FILED BY CO ON THIS INCIDENT BASED ON THE INFO PROVIDED THAT NO INJURY OCCURRED HOWEVER REOCCURRENCE COULD CONTRIBUTE TO A SERIOUS INJURY. EVAL OF THE INCIDENT DEVICES WAS CONDUCTED BY CO AND THE UNIT TESTED PER SPECS WITH NO PROBLEMS FOUND. THE PENCIL WAS TESTED AND IT WAS DETERMINED THAT THE ACTIVATION SWITCH WOULD REMAIN ON THUS ACTIVATING THE DEVICE, CREATING THE SPARKS DESCRIBED IN THE INCIDENT. THERE WAS A CONDUCTIVE CONTAMINATION BUILD UP ON THE SWITCH CONTACTS WHICH EVENTUALLY CAUSED THE SWITCH TO STICK AND REMAIN ON. IT WAS NOT DETERMINED WHAT THE AGE OF THE DEVICE WAS ALTHOUGH THE CONFIGURATION SUGGESTED POSSIBLY 6 TO 18 MONTHS. IT WAS ALSO NOT DETERMINED HOW MANY TIMES IT HAD BEEN CLEANED NOR WHETHER THE METHOD OF CLEANING COULD HAVE CAUSED THE CONTAMINATION TO OCCUR. ALL DEVICE OUTPUTS WERE IN SPEC, AS WELL AS THE RISK CURRENTS AND THERE WAS NO INDICATION OF OTHER PROBLEMS FOUND, NONE RELATING TO THE INCIDENT. CO REGRETS THE INCIDENT OCCURRED AS A RESULT OF THE PENCIL, HOWEVER THE PENCIL MALFUNCTION WAS RELATED TO CONTAMINATION OF UNKNOWN ORIGIN AND NO FURTHER CAUSE DETERMINED.
ADDITIONAL INFORMATION RECEIVED ON 10/9/96 INDICATES A PREVIOUS SPHINCTER WAS REMOVED DUE TO INFECTION.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS CYLINDERS.
DEVICE WAS IMPLANTED IN 5/89, DAY NOT INDICATED. ON 7/6/96 THE ENTIRE DEVICE WAS REMOVED, REASON FOR THE SURGERY WAS NOT PROVIDED.
INFO RECEIVED ON 9/5/96 INDICATES AN AUS DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AND REPLACED, DATE AND DR NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
TOTAL LOSS OF VENTRICULAR CAPTURE WAS OBSERVED.
DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION "YEARS AGO." UNABLE TO OBTAIN ADD'L INFO.
INFO RECEIVED ON 9/5/96 INDICATES DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. ANOTHER DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO.
THE DEVICE WOULD INTERMITTENTLY DISPLAY CONTINUOUS LIGHTS WITH NO ALARMS. THE CO SVC TECH INSPECTED THE DEVICE AND REPLACED THE RANDOM-ACCESS MEMORY IC AS A PRECAUTIONARY MEASURE. THE UNIT PASSED EXTENDED TESTING. IT IS NOT VERIFIED THAT THE DEVICE FAILED TO ALARM, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECS. BALLOON PRESSURE NOT WITHIN SPECS. PERINEAL CUFF ENCLOSURE PERFORMED WITHIN SPECS.
INFO RECEIVED ON 10/23/96 INDICATES THE DEVICE WAS REMOVED AND NOT REPLACED. ADD'L SERIAL AND LOT NO: 4735R 001.
DURING A ROUTINE EXPLANT, THE PACING LEAD COULD NOT BE PULLED OUT OF THE CONNECTOR WITHOUT DAMAGING THE END PIN.
THE BATTERY IS EXPIRED. NORMAL EVAL OF THE ATR CONNECTOR REVEALED THE PRESENCE OF BLOOD AND MAY HAVE MADE THE LEAD DIFFICULT TO REMOVE. THE DEVICE WAS RETURNED WITHOUT A SET SCREW AND THE ATR LEAD PIN WAS IN THE CAVITY. LITTLE EFFORT WAS NEEDED TO REMOVE THE LEAD PIN.
TUBING WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. CYLINDER WAS A WEAR LEAK.
ADDITIONAL INFO RECEIVED ON 10/01/96 INDICATES THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED ON 9/06/96.
PUMP HAD A FATIGUE LEAK. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL.
ADDITIONAL INFO RECEIVED ON 10/14/96 INDICATES BREAKAGE OF EXIT TUBING TO LEFT CYLINDER FROM PUMP AT IT'S JUNCTION WITH PUMP.
ADDITIONAL INFORMATION RECEIVED ON 10/1/96 INDICATES THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER DEVICE IMPLANTED ON 9/6/96 DUE TO "MALFUNCTION".
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD OR DAMAGE.
THE CUSTOMER ALLEGED A VENTILATOR FAILED TO CYCLE WITH NO ACTIVATION OF AN AUDIBLE ALARM. A CO CUSTOMER SVC ENGINEER INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED MALFUNCTION. AS A PRECAUTION THE POWER SUPPLY AND CPU PCB'S WERE REPLACED. IT IS NOT VERIFIED THAT THIS VENTILATOR'S AUDIBLE ALARM FAILED TO ACTIVATE, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WOULD NOT INFLATE. ANOTHER MODEL DEVICE WAS IMPLANTED.
CYLINDER HAD A WEAR LEAK. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. CYLINDER HAD A WEAR LEAK.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS LEFT CYLINDER.
DEVICE WAS REMOVED FROM THE PT DUE TO URETHRAL PERFORATION THAT NEVER HEALED FROM 4/9/96 SURGERY.
INFO RECEIVED ON 9/4/96 INDICATES THE DEVICE WAS REMOVED FROM THE PT DUE TO PROXIMAL EROSION ON 8/27/96. ANOTHER DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO.
DEVICE WAS REMOVED FROM THE PT DUE TO HEMATURIA AND PAIN. ANOTHER DEVICE WAS IMPLANTED.
THE SVC REPORT SHOWS THAT THERE WAS NO AUDIBLE ALARM. THE CO CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THAT THE ALARM WORKED INTERMITTENTLY WHEN THE WIRES FROM THE ALARM WERE WIGGLED. THE CSE INSPECTED THE DEVICE AND REPLACED THE ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLLEGED IN THIS REPORT.
THE BALLOON WAS REMOVED FROM THE PT DUE TO A TUBING EROSION INTO THE PERITONEUM.
THE VALVE WAS REMOVED DUE TO CENTRAL REGURGITATION AND STENOSIS APPROX 11 MONTHS POST IMPLANT. PTS AGE AT IMPLANT 67. THE VALVE WAS REPLACED WITH A 20MM MECHANICAL VALVE.
SUBMISSION OF INFO BY CO UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY THEREFORE, INFO ON THIS MEDWATCH FORM 3500A WAS COMPLETED BY CO WITH INFO RECEIVED FROM THE HEALTHCARE PROFESSIONAL. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A." H3 ANALYSIS: ANALYSIS SHOWS THE CUSPAL STIFFENING IS THE RESULT OF A GRADULAR, THROMBOTIC APPEARING HOST MATERIAL THAT COVERS THE OUTFLOW OF THE LEFT AND NON-CORONARY CUSPS. HOST TISSUE ON THE BIAS CLOTH AND OUTFLOW SURFACE OF THE RIGHT CUSP INDICATES THAT THE CUSP MAY HAVE BEEN HELD OPEN BY HOST TISSUE WHILE IN THE PT- RESULTING IN THE CENTRAL REGURGITATION. THE RADIOGRAPH SHOWS THE VALVE TO BE FREE OF MINERALIZATION.
DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS-LEFT CYLINDER, AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. TUBING HAD A WEAR LEAK.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER MODEL DEVICE IMPLANTED DUE TO PT DISSATISFACTION.
ADULT MALE CONSUMER USED PRODUCT IN EAR CANAL. CONSUMER ALLEGES THAT HE WITHDREW THE SWAB FROM THE EAR AND IT HAD NO COTTON ON IT. HE ALLEGES THAT HE HAD BLOOD IN HIS EAR. HE DID NOT LOOK AT THE SWAB BEFORE USING.
F10: PT 1738 2199. DEVICE 1670 1506. LABELING: LABELING CAUTIONS AGAINST USE IN THE EAR CANAL AND THAT IMPROPER USE CAN CAUSE INJURY. F12: HOME. CO REC'D ONE PACKAGE OF 375 SWABS FROM THE CUSTOMER. THE SWABS HAD BEEN REMOVED FROM THE PACKAGE AND REPLACED THE WRONG WAY. THE PACKAGE CONTAINED EIGHT SWABS THAT HAD NO COTTON ON ONE END EVEN THOUGH IT HAD THE CORRECT NUMBER OF SERRATIONS. IT COULD NOT BE DETERMINED FROM THE SAMPLE RETURNED IF THE SWABS WERE MADE WITH MISSING COTTON OR IF THE CONSUMERS HAD REMOVED THE BUD. THERE WERE NO PROBLEMS INDICATED IN THE BATCH RECORD OR THE MAINTENANCE LOG FOR THIS MACHINE. TESTING WAS PERFORMED ON THE SWABS FROM THE RETURNED PACKAGE. THE SWABS PASSED THE LOOSE WINDS TEST HOWEVER FIVE OF FIFTEEN SWABS DID NOT MEET THE REQUIREMENTS FOR ANCHORAGE OF NO SWABS WITH LESS THAN 10 LBS. OF ANCHORAGE. THERE WERE NO SWABS WITH LESS THAN 5 LBS OF ANCHORAGE. THIS TYPE OF COMPLAINT IS MONITORED AND HAS REC'D SIGNIFICANT RESOURCE FOCUS TO REDUCE AND HOPEFULLY TO ELIMINATE THE ISSUE. THE FOLLOWING CORRECTIVE ACTIONS ARE EXAMPLES OF WHAT IS BEING DONE TO REDUCE THE COMPLAINT. A TEAM HAS BEEN WORKING TO IDENTIFY THE FAILURE MODES THAT MAY CREATE A SWAB WITHOUT SUFFICIENT ANCHORAGE ON THE TWO DIFFERENT TYPES OF MACHINES IN THE SWAB DEPT. ON THE TYPE MACHINE THE FAILURE MODE WAS IDENTIFIED WHERE A MACHINE COULD COAST DOWN TOO SLOWLY ON A STOP. ALLOWING SEVERAL STICKS TO PASS THROUGH THE SERRATION AREA AFTER THE SERRATING JAWS HAD OPENED. THIS HAS BEEN CORRECTED THROUGH OPERATOR AWARENESS AS WELL AS ADJUSTMENTS TO THE PNEUMATIC BRAKING SYSTEM. ON THE VERSA TYPE MACHINES VARIOUS MACHINE MODIFICATIONS HAVE BEEN PERFORMED TO PREVENT SWAB STICKS FROM PASSING THROUGH THE SERRATING AREA OF THE MACHINE WITHOUT BEING SERRATED OR RECEIVING A REDUCED NUMBER OF SERRATIONS. TO PREVENT SWABS FROM BEING PRODUCED AND SHIPPED WITHOUT A COTTON BUD, ALL PACKAGES ARE INSPECTED 100% AS PART OF THE OPERATOR SELF INSPECTION PROCESS. EACH OPERATOR IS AUDITED TO DETERMINE THE EFFECTIVENESS OF THE OSI PROCESS. ALSO EACH MACHINE HAS A COIL BREAK INDICATOR THAT WILL NOTIFY THE OPERATOR WHENVER THE COTTON COIL BREAKS. THE INDICATORS ARE CHECKED PERIODICALLY TO MAKE SURE THAT THEY ARE WORKING. AS CAN BE OBSERVED IN THE ATTACHED GRAPH, THE DIRECTION OF THE TREND INDICATES THAT THE CORRECTIVE ACTIONS ARE HAVING A POSITIVE IMPACT.
THIS EVENT REPORTED AS: THROMBOSIS. NO FURTHER INFO AVAILABLE. THE GRAFT REMAINS IMPLANTED.
THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO EROSION AND INFECTION AND REPLACED. UNABLE TO OBTAIN ADD'L INFO.
THIS EVENT WAS REPORTED AS: THROMBOSIS. NO FURTHER INFO PROVIDED.
REVISION SURGERY WAS PERFOMED. UPON EXPOSURE OF THE TIBIAL AREA, THE PROSTHESIS ALLEGEDLY LIFTED OUT OF THE PROXIMAL TIBIA WITH NO RESISTANCE. EXAMINATION OF THE UNDERSIDE OF THE BASE OF THE COMPONENT AT THE HOSP ALLEGEDLY SHOWED NO ADHERENCE OF BONE CEMENT WHILE BONE OF THE PROXIMAL TIBIAL ALLEGEDLY WAS WELL FIXED WITH CEMENT. CEMENT WAS NOT MANUFACTURED BY CO.
CONCLUSION STATEMENT: WEAR CAUSED BY THIRD BODY WEAR FROM BONE CHIPS OR CEMENT. THREE CONTACTS HAVE BEEN MADE AND DOCUMENTED TO THE USER FACILITY REQUESTING COMPLETION OF MEDWATCH FORM. NO RESPONSE HAS BEEN RECEIVED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS CYLINDERS.
THERE WAS NO AUDIO ALARM DURING EXTENDED SELF TEST. THE CO'S CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE PROBLEM. THE CSE REPLACED THE ALARM ASSEMBLY AND FRONT PANEL PRINTED CIRCUIT BOARD AS A PRECAUTION. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
DEVICE WAS IMPLANTED ON 1/31/95. THE CUFF WAS REMOVED ON 3/17/95. THE CUFF WAS REIMPLANTED AND THE PUMP REVISED ON 8/15/95. THE CUFF WAS REMOVED ON 10/19/95. THE REMAINING COMPONENTS WERE REMOVED FROM THE PT AND AN ENTIRE DEVICE IMPLANTED ON 7/12/96.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO VALVE FAILURE.
INFO RECEIVED ON 9/6/96 INDICATES AN AUS DEVICE WAS REMOVED FROM THE PT ON 5/20/96, DUE TO EROSION AT THE PUMP, AND REPLACED. CO HAD REQUESTED ADD'L INFO.
THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED THE SURGON WAS FIRING THE DEVICE ACROSS THE BASE OF THE APPENDIX WHEN A LOUD CRACKING SOUND WAS HEARD. THE SURGEON ATTEMPTED TO OPEN THE DEVICE BY DEPRESSING THE RELEASE BUTTON, BUT COULD NOT OPEN IT. THE SURGEON THEN ATTEMPTED SEVERAL TIMES TO MANUALLY OPEN THE DEVICE, BUT WAS UNSUCCESSFUL. THE SURGEON DISCOVERED UPON OPENING THE DEVICE THE STAPLES WERE MALFORMED AND THE CUT LINE WAS APPROXIMATELY 5MM. THE SURGEON REPORTEDLY SUTURED AND EXCISED THE APPENDIX TO COMPLETE THE PROCEDURE. THE HOSP IS RETAINING THE DEVICE.
DEVICE WAS REMOVED FROM THE PT BECAUSE THE RIGHT CYLINDER STOPPED WORKING AND REPLACED.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR HOLE IN INNER TUBE
THE CUSTOMER ALLEGED THEY HAD A NO AUDIO ALARM CONDITION. THE CO CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE, VERIFIED THE ALLEGED MALFUNCTION AND REPLACED THE ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
AN AUS DEVICE WAS IMPLANTED ON 9/23/92. THE PUMP AND BALLOON WERE REVISED ON 10/6/93. THE BALLOON WAS REVISED ON 1/25/96. THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO A MALFUNCTION-LEAK AT CUFF-AND REPLACED.
REVISION SURGERY WAS PERFORMED DUE TO BROKEN FEMORAL COMPONENT AND BROKEN TIBIAL INSERT.
PRODUCT WAS MFG AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC. CONCLUSION STATEMENT: PRODUCT WORN DUE TO FRACTURED FEMORAL COMPONENT.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO MALFUNCTION; WOULD NOT INFLATE.
THIS EVENT WAS REPORTED AS: STENOSIS AND INSUFFICIENCY. NO FURTHER INFO AVAILABLE.
THE DEVICE WAS USED DURING A BOWEL RESECTION. IT WAS REPORTED THE TLC55 AND THE TP60 WERE USED FOR A BOWEL RESECTION OF A 19 YEAR OLD MALE CAR ACCIDENT VICTIM. FOUR DAYS POST OPERATIVE, THE ANASTOMOSIS LEAKED. THE PT WAS TRANSFERRED TO ANOTHER CITY, FOR REOPERATION AND ILEOSTOMY.
A1,4;B6,7,10: INFORMATION UNAVAILABLE. 9-9-96 DR. OPERATED ON A 19YEAR OLD BOY INVOLVED IN A SINGLE CAR ACCIDENT. THERE WAS BLOOD TRAUMA TO THE ABDOMEN. AT THE TIME OF THE EXPLORATION THERE WAS NOT TO BE A BLUNT INJURY TO THE RIGHT COLON. HE PERFORMED A RIGHT COLON RESECTION AND FUNCTIONAL END TO END ANASTOMOSIS. BOTH THE DISTAL SMALL BOWEL AND THE TRANSVERSE COLON WERE DIVIDED WITH A TLC55 INSTRUMENT. THE TLC 55 WAS THEN USED TO ANASTOMOSE THE BOWEL AND THE COMPLETION OF THE ANASTOMOSIS WAS CARREID OUT BY A TP60. THE PATIENT DID PASS A SMALL AMOUNT OF BLOOD POST OPERATIVELY WITH A BOWEL AND LATER SUSTAINED SEVERE ABDOMINAL PAIN. D5,6;H4,6: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
WHILE PERFORMING SVC FOR AN UNRELATED EVENT, THE CO CUSTOMER SUPPORT ENGINEER (CSE) DISCOVERED THAT THE AUDIBLE ALARM WAS INTERMITTENT. THE CSE WAS NOT AUTHORIZED TO REPAIR THE UNIT, BUT REPORTED THE PROBLEM TO THE CUSTOMER. THE CUSTOMER WILL ATTEND TO THE UNIT'S REPAIR. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
DEVICE WAS REMOVED FROM THE PT DUE TO SPONTANEOUS DEFLATION. ANOTHER DEVICE WAS IMPLANTED.
AN AUS DEVICE WAS IMPLANTED ON 6/20/94. THE CUFF WAS REMOVED ON 7/1/95. THE REMAINING DEVICE WAS REMOVED ON 7/1/95. THE REMAINING DEVICE WAS REMOVED FROM THE PT AND A COMPLETE DEVICE IMPLANTED ON 8/30/96.
THIS EVENT WAS REPORTED AS: INSUFFICIENCY. NO FURTHER INFO AVAILABLE.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. A FAX WAS SENT TO THE USER FACILITY ON 9/5/96. CO DID NOT RECEIVE A MEDWATCH REPORT FROM THE USER FACILITY. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT.
REAMER HEAD SEPARATED FROM WIRE BUNDLE. GUIDE WIRE WAS NOT BEING USED IN CONJUNCTION WITH THIS INSTRUMENT. HEAD WAS RETRIEVED.
GRAFT IMPLANTED AS FOREARM SHUNT FOR DIALYSIS ACCESS APPROX 4 1/2 YRS AGO. A RUPTURED PSEUDOANEURYSM RENDERED THE SHUNT NON-FUNCTIONAL, NECESSITATING REMOVAL. ACCORDING TO HEALTH CARE PROFESSIONAL, THIS WAS AN UNEXPECTED END-OF-LIFE FOR THE SHUNT.
THIS TYPE OF COMPLICATION IS LISTED IN THE INSTRUCTIONS FOR USE. THE SAMPLE CONSISTS OF A TAPERED VASCULAR GRAFT SURROUNDED BY FIBROUS AND ADIPOSE TISSUE. THE SAMPLE MEASURES 11.4 CM IN LENGTH. APPROX 4.5 CM OF THE GRAFT NEAR THE 7MM DIAMETER END IS LONGITUDINALLY OPENED AND THE GRAFT IS FLATTENED IN THIS REGION. FIBROUS TISSUE IS NOTED ALONG PORTIONS OF THE EXPOSED LUMINAL SURFACE. OTHER AREAS OF THE LUMINAL SURFACE ARE FREE OF TISSUE OR THROMBUS DEPOSTION. APPROX ONE CENTIMETER FROM THIS OPENING, A TRANSVERE HOLE IS APPARENT IN THE WALL WHICH MEASURE 1CM TRANSVERSELY BY 4MM LONGITUDINALLY. SEVERAL CANNULATION OR PUNCTURE SITES ARE NOTED IN THE TISSUE BED SURROUNDING THE GRAFT. AN OBLIQUE CLAMP IMPRESSION IS NOTED ACROSS THE 4MM END OF THE GRAFT AND MAY HAVE BEEN CREATED AT GRAFT REMOVAL. MUCH OF THE TISSUE SURROUNDING THE GRAFT APPEARS TO BE MATURE FIBROUS TISSUE AND ADIPOSE NODULES. BOTH THE GRAFT ENDS ARE CIRCUMFERENTIALLY INTACT, AT LEAST FROM VISUAL INSPECTION. THE LUMINAL SURFACE IS VARIABLY COVERED WITH THIN, THROMBUS ALONG INTACT REGIONS OF THE GRAFT. THREE SECTIONS ARE TAKEN FOR HISTORICAL EVALUATION. SECTION 9-0496-1A IS A LONGITUDINAL AT THE 7MM DIAMETER END AND ADJACENT TO THE LONGITUDINAL OPENING IN THE GRAFT WALL. A LONGTUDINAL SECTION THROUGH THE REGION OF THE RUPTURED PSEUDOANEURYSM IS IDENTIFIED AS 9-0496-1B. A THIRD LONGITUDINAL SECTION, 9-0496-IC, IS TAKEN IN THE REGION OF THE HOLE AND CANNULATED ARE, APPROX MID-SECTION OF THE SPECIMEN. THE REMAINDER OF THE GRAFT WILL BE CHEMICALLY TREATED TO REMOVE ALL ORGANIC MATERIAL AND EXAMINED GROSSLY. SECTION 9-0496-1A: THE OUTER SURFACE OF THIS LONGITUDINAL SECTION IS COVERED WITH A LAYER OF MUSCLE, FIBROUS CONNECTIVE, AND ADIPOSE TISSUES MEASURING UP TO 3MM IN THICKNESS. FIBROBLASTS AND SCATTERED MACROPHAGES AND FOREIGN BODY GIANT CELLS ARE PRESENT ALONG THE INTERFACE BETWEEN THE TISSUE AND THE GRAFT OUTER SURFACE. SEVERAL CAPILLARIES ARE NOTED IN THE REINFORCING FILM AND TOWARD OUTER ASPECT OF THE GRAFT INTERSTICES. THIN COLLAGEN INFILTRATES THE FULL THICKNESS OF THE GRAFT WALL. A FIBROUS PANNUS VARYING FROM 400U TO 1MM IN THICKNESS EXTENDS ALONG THE GRAFT LUMINAL SURFACE. THE PANNUS IS PARTIALLY OVERLAID BY LAMINATED FIBRIN-ERYTHROCYTE THROMBUS. CAPILLARY BUDS ARE PRESENT IN PORTIONS OF THE LUMINAL TISSUE. NO BACTERIA OR CALCIUM DEPOSITS ARE SEEN IN THE SECTION. SECTION 9-0496-1B: EXCEPT FOR FRAGMENTATION OF THE GRAFT WALL AS A RESULT OF NEEDLE PUNCTURES, THE HISTORICAL OBSERVATIONS ARE SIMILAR TO THOSE OF SECTION 1A. THOUGH PERFORATED, NO INTRINSIC ANEURYSMAL DILATATION OR DETERIORATION OF THE GRAFT MATERIAL IS NOTED. COLLAGEN INFILTRATION IS NOT THROUGHOUT THE PERFORATED SEGMENTS. SECTION 9-0496-1C: A SMALL, INTACT PSEUDOANEURYSM, CONTAINING PIECES OF GRAFT MATERIAL IN FIBROUS OUTER WALL AND A FIBRIN THROMBUS WITHIN CAPSULE, IS NOTED ALONG GRAFT OUTER SURFACE. THIS SECTION INCLUDES PORTIONS OF A LARGER RUPTURED PSEUDOANEURYSM. A SMALL CALCIUM DEPOSIT IS NOTED ON GRAFT WALL.
THE CUFF WAS REMOVED FROM THE PT DUE TO EROSION AT THE BLADDER NECK IN 1995, DAY NOT INDICATED. UNABLE TO OBTAIN ADD'L INFO.
THE VENT WENT INOP WITH NO AUDIBLE ALARM, VISUAL OBSERVATION SHOWED ERROR CODE INDICATING THE UNIT ENTERED SAFTY VALVE OPEN MODE. THE CO CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF TESTING. THE CO REPLACED THE POWER SUPPLY, POWER SWITCH, AND ALARM ASSEMBLY AS A PRECAUTION. IT IS NOT VERIFIED THAT THE ALLEGED MALFUNCTION OCCURRED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT DUE TO RIGHT CYLINDER NON-FUNCTIONING. ANOTHER BRAND CYLINDER IMPLANTED.
THIS EVENT WAS REPORTED AS: REGURGITATION. NO FURTHER INFO AVAILABLE.
THE DEVICE WAS USED DURIND A BOWEL RESECTION. IT WAS REPORTED THE TLC55 AND THE DEVICE WAS USED FOR BOWEL RESECTION OF A 19 YEAR OLD MALE CAR ACCIDENT VICTIM. FOUR DAYS POST OPERATIVE, THE ANASTOMOSIS LEAKED. THE PT WAS TRANSFERRED TO LACROSSE, WI, FOR REOPERATION AND ILEOSTOMY.
A1,4;B6,7;D10: INFO UNAVAILABLE. D5,6;H4,6: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
A REVISION SURGERY WAS PERFORMED DUE TO SCARRING AROUND THE RESERVOIR. NO COMPONENTS WERE REMOVED OR REPLACED.
IMPLANT WAS EXPLANTED DUE TO A FRACTURED BASKET. CLENCHING AND BRUXISM WERE NOTED.
86 = DIMENSIONAL ANALYSIS. 100= VISUAL EXAMINATION SHOWED THAT THE BASKET OF THE IMPLANT WAS FRACTURED. TOOL MARKS WERE NOTED ABOUT THE SURFACE OF THE IMPLANT. THE RETURNED COMPONENT MET THE REMAINING INTERPORE VISUAL AND DIMENSIONAL SPECS.
THE SVC REPORT SHOWS WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE UNIT THE SVC TECH (ST) VERIFIED THE DEVICE DID NOT PASS THE VOLUME DELIVERY TESTING. THE ST INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL.
THIS EVENT WAS REPORTED AS: "DYSFUNCTION" AND CALCIFICATION. NO FURTHER INFO AVAILABLE.
F10: DEVICE CODE: 2203 = HOST TISSUE OVERGROWTH. H6: 86 = X-RAY ANALYSIS. EXAMINATION OF THE VALVE IN CO'S LABORATORY REVEALED HOST TISSUE OVERGROWTH ENCROACHED ONTO EACH CUSP AND FUSED BOTH ATTACHMENT SITES OF THE RIGHT-CORONARY CUSP, RESULTING IN STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS, DETACHED LEAFLET AND INCOMPLETE COAPTATION. X-RAY ANALYSIS REVEALED MINOR CALCIFICATION WITHIN THE FREE MARGIN OF THE RIGHT-CORONARY CUSP. EXTENSIVE STENT DISTORTION WAS ALSO NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO HOST TISSUE OVERGROWTH. THESE FINDINGS WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT DUE TO AN ANEURYSM FORMATION AND REPLACED.
THE SVC REPORT SHOWS WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE UNIT THE CO TECH (ST) VERIFIED THE DEVICE DID NOT PASS THE PRESSURE LEAK TESTING. THE ST INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
LOCALIZED INFECTION DEVELOPED IN PT POST-OPERATIVELY AFTER IMPLANTATION OF SPINE SYSTEM IMPLANTS. RE-OPERATION PERFORMED 9/19/96. PHYSICIAN ALSO FOUND NUTS WERE NOT TIGHTLY PLACED ON SCREW/ROD. NO ADD'L INFO ON PT STATUS OR EVENT AVAILABLE AT THIS TIME. ADD'L DATA HAS BEEN REQUESTED FROM THE PHYSICIAN. ACCORDING TO HOSP/STAFF, INFECTION ISSUE IS NOT ISOLATED TO THIS EVENT OR SPINE SYSTEM IMPLANTS. THIS EVENT IS OCCURRING BELOW THE FREQUENCY AND SEVERITY THAT ARE USUAL FOR THESE DEVICES.
THIS EVENT WAS REPORTED AS: UNK. NO FURTHER INFO AVAILABE.
EXAMINATION OF THE VALVE IN CO'S LABORATORY REVEALED CALCIFICATION WITHIN EACH CUSP, ESPECIALLY CONCENTRATED AT EACH ATTACHMENT SITE, WHICH RESULTED IN CONVOLUTED CUSPS, STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE LEAFLET DISRUPTIONS, INCLUDING DETACHMENT OF THE RIGHT AND NONCORONARY CUSPS AND INCOMPLETE COAPTATION. HOST TISSUE OVERGROWTH FUSED EACH ATTACHMENT SITE AND ENCROACHED ONTO EACH CUSP, CONTRIBUTING TO STENOSIS OF THE VALVE. X-RAY ANALYSIS REVEALED CALCIFICATION WITHIN THE AORTIC WALL AND BELLY OF EACH CUSP. STENT DISTORTION WAS ALSO NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO CALCIFICATION.  H6: 86= X-RAY ANALYSIS.
IMPLANTED ON 8/7/96. PT DISLOCATED POST OPERATIVE WHEN CROSSING HER LEG. DURING A CLOSED REDUCTION ATTEMPT, BI-POLAR DISASSOCIATED. PT WAS REVISED ON 8/24/96.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. A FAX WAS SENT ON 9/16/96 TO THE USER FACILITY. CO DID NOT RECEIVE A MEDWATCH FROM THE USER FACILITY. CURRENT INFO IS INSUFFICENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
THIS EVENT WAS REPORTED AS ENDOCARDITIS. NO FURTHER INFO PROVIDED.
THE DEVICE WAS APPLIED DURING A TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON REMOVED THE DEVICE BY FORCE AND RESECTED THE DAMAGE TISSUE. ANOTHER DEVICE WAS APPLIED ON THE PROXIMAL SIDE TO COMPLETE THE PROCEDURE.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS-RIGHT CYLINDER.
THIS EVENT WAS REPORTED AS: REGURGITATION.
RIGHT BRACHIAL PORT INFUSING WITHOUT PROBLEMS BUT NO BLOOD RETURN. X-RAY WAS DONE. TEAR IN CATHETER WAS NOTED AND PORT WAS REMOVED.
F10 CODE #1069 - LABELED. H10 USER FACILITY REPORT ATTACHED. THE EXPLANTED PORT WAS RETURNED FOR EVALUATION. THE PHYSICIAN REPORTED THAT THE PORT WOULD INFUSE BUT NOT ASPIRATE. THE PORT WAS RETURNED WITH A SEGMENT OF CATHETER ATTACHED TO THE PORT, AND A SEGMENT UNATTACHED. THE ATTACHED SEGMENT EXTENDED APPROX 0.9 INCH FROM THE BASE OF THE PORT. THE DETACHED SEGMENT MEASURED 13.6 INCHES LONG. THE TWO CATHETER SEGMENTS APPEAR TO COMPRISE THE CATHETER. THE CROSS-SECTION OF THE FRACTURE APPEARED TO BE SOMEWHAT ELLIPTICAL. USING A SYRINGE AND A NON-CORING NEEDLE, WATER COULD BE INJECTED AND ASPIRATED THROUGH THE PORT WITH NO DIFFICULTY. HOWEVER, PLUGS OF BLOOD WERE PRESENT IN THE DETACHED CATHETER SEGMENT. ACCORDING TO THE PHYSICIAN, "A TEAR IN CATHETER WAS NOTED". THIS CONDITION, TOGETHER WITH A PLUGGED-UP PORTION OF THE CATHETER DISTAL TO THE "TEAR" COULD HAVE RESULTED IN DIFFICULTY REPORTED. HOWEVER, THE CAUSE OF THE CATHETER FRACTURE CANNOT BE DETERMINED.
THE PRODUCT WAS APPLIED TO CORRECT THE MYELOMENINGOCEOLE LUMBO SACRALIS CONDITION THE INFANT WAS DIAGNOSED WITH A BIRTH. POST-OPERATIVELY THE PT'S WOUND WAS TREATED CONTINUOUSLY WITH PEROXIDE. REPORTEDLY, THE SUTURE DISINTEGRATED THREE DAYS POST-OPERATIVELY REQUIRING A SECOND WOUND REPAIR.
10/4/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
RPTR HAS SEEN NUMEROUS OCCURRENCES OF "PLASTIC FIBERS AND MEDICAL GRADE LUBRICANT" ON INSULIN SYRINGE NEEDLES OVER MANY YEARS OF USE. SHE HAS REPORTED HER FINDINGS TO THE MFR NUMEROUS TIMES AND THEIR RESPONSE IS THAT THE MATERIAL IS ON ANTICIPATED PART OF THE PRODUCTION PROCESS.
THIS EVENT WAS REPORTED AS DEATH, CAUSE UNK. NO FURTHER INFO PROVIDED.
IMPLANTED ON 6/6/93. REVISED ON 9/04/96. DUE TO FRACTURE OF MODULAR HEAD.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. A FAX WAS SENT ON 9/16/96, TO THE USER FACILITY. CO DID NOT RECEIVE A MEDWATCH REPORT FROM THE USER FACILITY. CURRENT INFO IS UNSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO SIZE-TOO SHORT.
THE PORT WAS PLACED 7/18/96. THE PORT WAS REMOVED 8/31/96 AFTER THE PORT  SEPTUM BECAME DISLODGED. IT IS UNKNOWN WHAT WAS BEING INFUSED OR HOW THE DISLODGED SEPTUM WAS DISCOVERED.
THE HOSP IS RETAINING THE DEVICE. A LOT HISTORY REVIEW REVEALED NO RELATED MFG ISSUES AND NO SIMILAR PRODUCT COMPLAINTS.
THE EVENT WAS REPORTED AS DEATH CAUSE UNK. NO FURTHER INFO PROVIDED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER MODEL DEVICE IMPLANTED DUE TO FLUID LOSS.
THE EVENT WAS REPORTED AS THROMBOSIS. NO FURTHER INFO PROVIDED.
DURING AN INFUSION OF CHEMOTHERAPY, RESISTANCE WAS NOTED AND THERE WAS BULGING AT THE SUBCUTANEOUS INTRACLAVICULAR LEVEL. IT IS BELIEVED THERE WAS SUBCUTANEOUS CATHETER LEAKAGE.
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A LOT HISTORY REVIEW INDICATED NO RELATED MFG ISSUES AND ONE OTHER PRODUCT COMPLAINT OF A SIMILAR NATURE. THIS OTHER COMPLAINT WAS FOUND TO BE UNCONFIRMED.
STENT WAS MOUNTED ON THE BALLOON CATHETER AND DELIVERY TO THE LESION SITE WAS MADE. UPON INFLATION OF THE BALLOON, THE BALLOON RUPTURED AND IT WAS DIFFICULT TO REMOVE THE BALLOON CATHETER FROM THE PT. A DISSECTION WAS NOTED. THE DISSECTION WAS SUCCESSFULLY TACKED UP WITH 3 STENTS. THE PT IS REPORTED AS FINE. THE PHYSICIAN INDICATED THAT THE DEFLATED BALLOON MAY HAVE CAUGHT ON A STENT STRUT MAKING IT DIFFICULT TO REMOVE THE CATHETER FROM THE PT.
EVAL SUMMARY: THE DEVICE WAS RECEIVED FOR EVAL ON 9/10/96. ANALYSIS INDICATED THAT A LONGITUDINAL RUPTURE OF THE BALLOON HAD OCCURRED. THE BALLOON MATERIAL WAS WRINKLED, SCRATCHED AND MANGLED. THE DISTAL INNER MEMBER OF THE DEVICE WAS KINKED. CO'S CONCLUSION OF THE RETURNED DEVICE IS THAT THE BALLOON RUPTURED DUE TO MECHANICAL DAMAGE. THE MECHANICAL DAMAGE WAS MOST LIKELY CAUSED BY INTERACTION WITH THE STENT AND THE KINKING OF THE INNER MEMBER WAS MOST LIKELY CAUSED BY ATTEMPTS TO REMOVE THE DEVICE FROM THE PT.
THIS EVENT WAS REPORTED AS "STRUCTURAL DETERIORATION AND DEGENERATION."
NEEDLES SEPARATE FROM SYRINGE. UPON OPENING THE PACKAGES OF 10, APPROX 50% OF THE NEEDLES ARE DETACHED FROM THE SYRINGES. SYRINGES WERE RETURNED TO THE PHARMACY BY THE PT AND ONE PACKAGE OPENED IN THE PHARMACY WAS NOTED TO BE AFFECTED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS-MALFUNCTION.
PT WAS ADMITTED ON 8/27/96 WITH AN IMPLANTED CATHETER. THE DISTAL END HAD SEPARATED FROM THE MAIN BODY AND HAD TO BE RETRIEVED BY HEART CATH PROCEDURE ON 8/28/96.
THE FACILITY RETAINED THE DEVICE AND IT WAS NOT AVAILABLE FOR EVALUATION. THE REPORTER DID NOT KNOW WHAT WAS BEING INFUSED THROUGH THE DEVICE, AND DID NOT HAVE A LOT NUMBER RECORDED.
THIS EVENT WAS REPORTED AS "STRUCTURAL DETERIORATION AND DEGENERATION." NO FURTHER INFO PROVIDED.
DEVICE WAS REMOVED FROM THE PT DUE TO PUMP EROSION, INFECTION THROUGH THE SCROTUM, AND PT DISSATISFACTION-DIFFICULT TO USE. A MALLEABLE DEVICE WAS IMPLANTED.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CYLINDER PERFORMED WITHIN SPECIFICATIONS. TUBING HAD OR DAMAGE.
PT PRESENTED WITH PAIN IN THE RIGHT AXILLA OCCURRING DURING INFUSION OF ANTIBIOTICS. NO SIGNS OF LEAKAGE OR INFLAMMATION WERE FOUND. CONTRAST STUDY ON 6/14/96 FAILED TO IDENTIFY LEAKAGE. IT WAS NOTED THAT PT WAS MORE COMFORTABLE IF HIS DRUGS WERE INJECTED WHEN SITTING UP. ON 6/17/96 PT STILL COMPLAINED OF PAIN. CARDIAC ECHO PERFORMED SECOND CONSTRAST STUDY DONE ON 6/18/96 WHICH INDICATED LEAKAGE AT OR NEAR THE PORTAL/CATHETER CONNECTION SITE. SYSTEM WAS EXPLANTED. AT EXPLANTATION IT WAS FOUND THAT THE CATHETER AND PORTAL WERE SEPARATED. SYSTEM COMPONENTS DISCARDED IN OR.
ENTIRE FORM COMPLETED BY MFR. ADD'L INFO HAS BEEN REQUESTED BUT HAS NOT BEEN OBTAINED AT THIS TIME.
NURSE ENTERED PT'S ROOM AND FOUND HIM UNRESPONSIVE, NOTED HANDS WERE CYANOTIC AND A CHANGE IN BREATHING PATTERN. NOTED THAT SETTINGS ON PUMP WERE CORRECT AND THAT 93CC'S OF MORPHINE SULFATE (MG./1CC) HAD INFUSED IN APPROX. 4 1/2 HOURS. ONE AMPULE OF NARCAN WAS GIVEN INTRAVENOUSLY. PT BECAME RESPONSIVE AFTER THE NARCAN AND RETURNED TO THE STATUS HE WAS AT PRIOR TO THE IN INCIDENT.
ON 3/1/96 DEVICE WAS IMPLANTED. ON 5/14/96 THE LEFT CYLINDER WAS REMOVED. ON 8/20/96 THE RIGHT CYLINDER, PUMP, AND RESERVOIR WERE REMOVED FROM THE PT AND ONE CYLINDER, PUMP AND RESERVOIR IMPLANTED DUE TO INFECTION, SALVAGE PROCEDURE PERFORMED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. RESERVOIR HAD OR DAMAGE.
THE PRODUCT WAS APPLIED DURING A BREAST BIOPSY PROCEDURE. REPORTEDLY, THE PT HAD AN ALLERGIC REACTION POST-OPERATIVELY. THE SURGEON REOPERATED TO REMOVE SUTURE AND TISSUE. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
10/2/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
DEVICE WAS IMPLANTED ON 2/1/93. ON 4/28/93 THE LEFT CYLINDER WAS REVISED. ON 8/26/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT BECAUSE IT WAS "NON-FUNCTIONING."
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A FATIGUE AND WEAR LEAK. TUBING WAS FUNCTIONAL.
DURING LAPAROSCOPIC CHOLECYSTECTOMY, 10MM TROCAR INSERTED (POST PLACEMENT CHECK) INTRA-UMBILICAL WITH DIFFICULTY. THE LAPAROSCOPE WAS INSERTED AND BLOOD NOTED IN ABDOMEN. SECOND 10 MM TROCAR INSERTED SO FIRST SIGHT COULD BE EXAMINED TO BLEEDING. NO BLEEDING FROM TROCAR SITE. DECISION MADE TO OPEN ABDOMEN. PRESSURE PLACED ON AORTA, THEN CLAMPS. RT ILIAC ARTERY AND VEIN DAMAGED AND VENTRICLES REPAIRED.
ALLEGED COLLAGEN VASCULAR DISEASE. FOLLOW-UP FINDINGS: AS PER PHYSICIAN, ETIOLOGY UNKNOWN. OUTCOME: UNDETERMINED. CONNECTIVE TISSUE/AUTOIMMUNE DISORDERS.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF MMC'S EVALUATION OF THE DEVICE. CO APPROACH TO MDR COMPLICANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. FILING A MDR DOES NOT CONSTITUTE AN ADMISSION BY MMC THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. REPORTS ARE BASED ON INFO SUPPLIED TO CO AND THE SUBSEQUENT INVESTIGATION. CO CONSIDERS THIS INFO TO BE HIGHLY CONFIDENTIAL AND, THEREFORE, REQUEST PROTECTECTION OF IT FROM ANY REQUEST, PURSUANT TO 21 CFR PART 803.9 (B). EVALUATION OF THE DEVICE NOTED A SHARP EDGED OPENING IN THE IMPLANT. THE VALVE LEAKED DURING THE LEAK TEST. DARK PARTICLES WERE NOTED IN THE VALVE CHANNEL. THE DEVICE WAS IMPLANTED FOR ALMOST 4 YEARS. THE NOTED DAMAGE TO THE IMPLANT IS NOT RELATED TO THE ALLEGED EVENT OF COLLAGEN VASCULAR DISEASE, AND PROBABLY OCCURRED AS A RESULT OF THE EXPLANTATION PROCEDURE AND/OR SUBSEQUENT POST OPERATIVE HANDLING. THERE IS NO INDICATION OF THE DEVICE FAILING TO PERFORM AS INTENDED. THE ETIOLOGY OF THE COLLAGEN VASCULAR DISEASE IS UNKNOWN.
DEVICE WAS IMPLANTED ON 5/1/95. THE RIGHT CYLINDER WAS REVISED ON 12/18/95. THE ENTIRE DEVICE WAS REMOVED DUE TO INFECTION AND PAIN AT TUBING AROUND PENIS ON 7/19/96.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CONNECTOR WAS FUNCTIONAL.
THE PRODUCT WAS APPLIED DURING A BREAST BIOPSY PROCEDURE. REPORTEDLY, THE PT HAD AN ALLERGIC REACTION POST-OPERATIVELY. THE SURGEON REOPERATED TO REMOVE SUTURE AND TISSUE. THE HOSP HAS REPORTED THAT THE PT'S STATUS SATISFACTORY.
10/2/96 MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
A CONNECTOR WAS REMOVED FROM THE PT DUE TO FLUID LOSS AT TUBING TO CYLINDER AND REPLACED.
TUBING HAD A FATIGUE AND WEAR LEAK. CONNECTOR WAS FUNCTIONAL.
THE PORT WAS PLACED ON THE LEFT SIDE ON 8/23/96. IT WAS REPORTED THAT THERE WAS DIFFICULTY INFUSING MEDICATION INTO THE PORT AND TISSUE SWELLING AROUND THE PORT. AN X-RAY WAS TAKEN WHICH SHOWED THE CATHETER HAD BROKEN AWAY FROM THE PORT. THE PORT WAS REMOVED AND REPLACED ON 8/28/96.
THE PORT FLUSHED AND ASPIRATED NORMALLY. UNDER MAGNIFICATION, THE CATHETER TUBING WAS SEEN TO HAVE BEEN FORCED ON THE PORT STEM AND THE TUBING WAS FLARED AT THE PORT STEM SHOULDER. NEXT TO THE FLARE, IDENTATIONS SIMILAR TO MARKS MADE BY A SERRATED JAWED INSTRUMENT WERE SEEN IN THE TUBING. THE DISTAL END OF THE TUBING WAS SEVERED JUST PRIOR TO THE PORT STEM BARB. THIS TYPE OF DAMAGE CAN OCCUR WHEN THE CATHETER IS FORCED ON THE PORT STEM AND THE CATH-LOCK IS NOT PROPERLY ENGAGED ON THE PORT STEM.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS-PINHOLE IN CYLINDER AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK. CYLINDER HAD A FATIGUE LEAK.
THE PRODUCT WAS APPLIED DURING A HYDROCELECTOMY PROCEDURE. REPORTEDLY, THE PT HAD AN ALLERGIC REACTION POST-OPERATIVELY. THE SURGEON REOPERATED TO REMOVE SUTURE AND TISSUE. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
10/2/96 MEDTWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE PORT WAS IMPLANTED 7/1/96. THE PORT WAS REMOVED 8/15/96 DUE TO A BREAK IN THE CATHETER AT THE PORT STEM.
THE DEVICE WAS DISCARDED BY THE HSP PATHOLOGY DEPARTMENT AND WAS NOT RETURNED FOR EVALUATION.
THE RESERVOIR WAS REMOVED FROM THE PT DUE TO POSSIBLE NEEDLE DAMAGE.
THE PT'S ENTERAL FEEDING TUBE WAS FOUND CONNECTED TO THE OXYGEN TUBING FOR HIS NASAL CANNULA. THE PT'S ABDOMEN WAS DISTENDED AND HE COMPLAINED OF PAIN. A SHORT TIME LATER, THE PT BECAME UNRESPONSIVE, WAS CODED AND TRANSFERRED TO ICU. X-RAYS REVEALED FREE AIR IN THE ABDOMEN AND A PERFORATION OF THE COLON. SUBSEQUENTLY A COLOSTOMY AND G-TUBE WERE PLACED. THE PT DEVELOPED A SEPSIS AND HIS CONDITION DETERIORATED. HE EXPIRED.
SUTURE BREAKAGE POST OPERATIVE. ONE DAY FOLLOWING ABDOMINAL HYSTERECTOMY, SUTURE BREAKAGE OCCURRED REQUIRING RE-OP TO REPAIR. CO'S INTERNAL CONTROL NUMBER IS: 9600625-00.
RETURNED WAS ONE EXPLANTED PIECE OF SIZE 0 SUTURE MATERIAL, APPROX. 13CM LONG, BELIEVED TO BE FROM THE ABOVE STATED PRODUCT CODE. NO BATCH NUMBER IDENTIFICATION WAS PROVIDED. THE RETURNED PIECE WAS EXAMINED UNDER A MICROSCOPE AT 24-40X. ONE END OF THE SUTURE APPEARED BLUNT, WHICH IS CONSISTENT WITH HAVING BEEN CUT. THE SAME END ALSO DEMONSTRATED SOME ABRASION ON THE SIDE OF THE SUTURE AT THAT END. IT WAS CONCLUDED THAT THE RETURNED SUTURE SEGMENT HAD ONE END WHICH APPEARED CUT, WHILE THE OTHER END APPEARED PARTIALLY CUT AND SUBSEQUENTLY SEPARATED BY FORCE.
ON 1/27/92 PUMP AND RESERVOIR WERE IMPLANTED. ON 8/3/92 CYLINDERS WERE IMPLANTED. ON 8/20/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A LEAK IN THE CYLINDERS.
THE SECTIONS OF BREAST TISSUE EXCISED SHOWED CHRONIC INFLAMMATION FAT NECROSIS, FIBROSIS, AND A MULTINUCLEATED FOREIGN BODY GIANT CELL REACTION FOCALLY ASSOCIATED WITH IDENTIFIABLE SUTURE MATERIAL.
A1,2;B6,7;D10: INFO NOT PROVIDED. D5,6;H4,6: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
10/15/96 DR. WAS PERFORMING A PULMONARY RESECTION. HE USED THE TLV30 ON THE PULMONARY ARTERY. AFTER FIRING THE INSTRUMENT AND DIVIDING THE VESSEL, THERE WAS MASSIVE BLEEDING. HE WAS ABLE TO CONTROL IT, BUT A LARGE AMOUNT OF BLOOD HAD TO BE REPLACED. THE PATIENT HAS SURVIVED. AT THE SURGERY THERE WERE 2 SIMILAR INSTRUMENTS PITCHED ON THE TABLE. 10-15-96 HE HAD INSPECTED AND IT APPEARED AS IF THEY BOTH CONTAINED STAPLES. HE WAS CONCERNED TO HIM THAT THE STAPLE LINE SHOULD BE INSPECTED PRIOR TO DIVIDING THE VESSEL. HE IS NOT CERTAIN WHICH INSTRUMENT ARE BEING RETURNED TO CO.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-PROXIMAL RIGHT CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A FATIGUE LEAK. TUBING WAS FUNCTIONAL.
NEEDLE BREAKAGE OCCURRED DURING ABDOMINAL HYSTERECTOMY PROCEDURE EXTENDING SURGERY APPROX. ONE HOUR TO LOCATE AND RETRIEVE NEEDLE PIECE. CO'S INTERNAL CONTROL NUMBER IS: 9630176-00.
TEN NEEDLES FROM THE UNOPENED PACKETS RETURNED WERE VISUALLY EXAMINED AND THEN TESTED FOR STRENGTH AND DUCTILITY.  ZERO VISUAL NONCONFORMANCES WERE OBSERVED AND EACH NEEDLE MET THE CO REQUIREMENTS FOR STRENGTH AND DUCTILITY.  THE RETURNED BROKEN NEEDLES WERE EVALUATED BY THE MATERIALS ENGINEERING DEPARTMENT USING THE SCANNING ELECTRON MICROSCOPE (SEM).  SEVERAL SEM PHOTOGRAPHS WERE TAKEN SHOWING THE NEEDLE WIRE SURFACE, AND HIGH MAGNIFICATION VIEW DEPICTING THE MODE OF FRACTURE.  THERE WERE NO SIGNS OF MATERIAL OR MANUFACTURING DEFECTS. THERE WAS NO PRODUCT MALFUNCTION.
THE PT'S ENTERAL FEEDING TUBE WAS FOUND CONNECTED TO THE OXYGEN TUBING FOR HIS NASAL CANNULA. THE PT'S ABDOMEN WAS DISTENDED AND HE COMPLAINED OF PAIN. A SHORT TIME LATER, THE PT BECAME UNRESPOSIVE, WAS CODED AND TRANSFERRED TO ICU. X-RAYS REVEALED FREE AIR IN THE ABDOMEN AND A PERFORATION OF THE COLON. SUBSEQUENTLY A COLOSTOMY AND G-TUBE WERE PLACED. THE PT DEVELOPED SEPSIS AND HIS CONDITION DETERIORATED. HE EXPIRED.
ON 1/5/92 DEVICE WAS IMPLANTED. ON 2/27/96 MORE FLUID WAS ADDED TO THE DEVICE. ON 7/22/96 THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO HOLE IN CONNECTOR TUBING.
PUMP PERFORMED WITHIN SPECIFICATIONS. TUBING WAS FUNCTIONAL. TUBING HAD A FATIGUE AND WEAR LEAK.
MFR RECEIVED A REPORT OF A PT FALLING FROM A LIFT AS A RESULT OF A SLING BECOMING UNHOOKED DURING TRANSFER. THE PT ALLEGEDLY SUSTAINED A BROKEN ARM AND LEG. THE LIFT INVOLVED HAS BEEN IN SERVICE FOR OVER 7 YRS AND NO MALFUNCTION HAS BEEN REPORTED.
PHYSICIAN USED A SNARE DURING THE REMOVAL OF A FEEDING TUBE. DURING THE PROCEDURE THE BUMPER WAS BEING REMOVED FROM THE STOMACH USING THE SNARE. THE LOOP OF THE SNARE BROKE LEAVING THE BUMPER IN THE ESOPHAGUS. THE PT WAS RE-INTUBATED AND THE LOOP WAS REMOVED USING A SECOND SNARE. THE BUMPER WAS ALSO RETRIEVED WITH NO OBSTRUCTION OR FURTHER INCIDENT TO PT.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE PT HAD SEVERED LEFT LEG. PROSTHETIC IMPLANT FOR HIP, CUT INTO CYLINDER CAUSING LEAK. ADD'L LOT #: BD817 003, ADD'L SERIAL #: BD817 003.
THE DEVICE WAS USED DURING A CYSTECTOMY PROCEDURE. IT WAS REPORTED THE MCL20 WAS FULLY FIRED, CLIPS WERE IN PLACE AND AFTER THE STRUCTURES WERE LIGATED, THE CLIPS FELL OFF. THE SURGEON STATED "IT WAS A MESS" AND "THE PT IS STILL IN THE HOSP WITH COMPLICATIONS FROM HEMATOMA". REP REPORTS THE PT WAS STILL IN THE HOSP AS OF 9/6/96 WITH MULTIPLE HEMATOMAS. 9/9/96 REP REPORTS SHE IS RETURNING ONLY 1 STERILE INSTRUMENT.
D6; DEVICE RETURNED WITH NO LOT IDENTIFICATION. 9/13/96 SURGEON WAS PERFORMING A CYSTECTOMY AND WAS USING MULTIPLE CLIPS. HE STATES SOMETIMES NO CLIPS WOULD COME OUT WHEN THE INSTRUMENT WOULD BE FIRED AND OTHER TIMES MULTIPLE CLIPS WOULD COME OUT AND THE CLIPS WERE NOT SECURE. THE PT IS DOING WELL AND THERE WERE NO CONSEQUENCES TO THE PT.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. TUBING HAD OR DAMAGE.
10/2/96 MEDWATCH REPORT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. THE HOSP HAS REPORTED THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
SUMMONS AND COMPLAINT STATES THAT FOLLOWING BREAST SURGERY, PT'S INCISIONS BECAME INFECTED RESULTING IN SCARRING AND DISFIGUREMENT. RE-OP WAS PERFORMED TO REMOVE SUTURE MATERIAL. CO'S INTERNAL CONTROL NUMBER IS: 9600618-00.
H7-THIS PRODUCT ALLEGED TO HAVE BEEN PART OF A PRODUCT RECALL IN 1994 WHICH HAS BEEN REEPORTED IN PRODUCT LIABILITY LITIGATION RECEIVED ON 9/10/96.
ATTEMPTED TO PERFORM A CIRCUMCISION WITH CLAMP. STARTED PROCEDURE; APPEARED TO BE PROBLEM. REMOVED CLAMP. LACERATION AT THE BASE OF THE SHAFT COMPLETELY ENCIRCLING THE PENIS THROUGH THE SKIN TISSUE ONLY. WEIGHT 6 LB 3 OZ.
THE CYLINDER WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-HOLE IN CYLINDER.
CYLINDER HAD A FATIGUE LEAK. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
THIS EVENT WAS REPORTED AS ENDOCARDITIS AND REGURGITATION. NO FURTHER INFO PROVIDED.
A4;B,6,7;D10: INFO INAVAILABLE: 9/9/96 1400 MESSAGE AND 800# LEFT ON ANSWERING MACHINE FOR RISH MGMT. BAH 9/9/96 1505 AND SAID SHE WAS AWARE OF EVENT AND WOULD SUBMIT A MEDWATCH TO EES AND FDA. TKB 10/17/96 PT ID # 173282, DOB 4/29/57, FEMALE, KJB
MEDWATCH # 1001 WAS RECEIVED ON 10/17/96 STATING "LAPROSCOPIC CHOLECYSTECTOMY CLIP APPLIED TO ARTERY. CLIP CAME OFF ARTERY. CASE WAS CONVERTED TO AN OPEN PROCEDURE AND THE ARTERY LIGATED. THIS EXTENDED RECOVERY TIME AND HOSPITILIZATION OF PT." 9/9/96 DR. E. PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY. HE WAS USING AN ER320. AFTER PLACING 3 CLIPS ALONG CYSTIC ARTERY, VESSEL WAS DIVIDED. AT THIS POINT IN TIME, ALL APPEARED TO BE NORMAL. CYSTIC DUCT WAS HANDLED IN A SIMILAR FASHION. WHILE REMOVING GALLBLADDER FROM BED, A SIGNIFICANT AMOUNT OF BLEEDING WAS ENCOUNTERED WHICH REQUIRED CONVERSION TO AN OPEN PROCEDURE. AT THIS TIME IT WAS NOTED CLIPS WERE NO LONGER ON CYSTIC ARTERY AND RECOVERY OF CLIPS SHOWED THAT THEY WERE NOT SECURE. THESE CLIPS WERE DISPOSED AS WAS INSTRUMENT. 9/9/96, THERE WAS NO VIDIO THEREFORE, WE HAVE NO MATERIAL TO EXAMINE,
FOLLOWING AN ACCIDENT IN 1993, PT WAS IMPLANTED WITH A TUBULAR BONE PLATE IN EACH FIBULA. FUSION OCCURRED. OVER THE YEARS, PT COMPLAINED OF INCREASING PAIN, SWELLING AND BROWN SPOTS ON SKIN ABOVE IMPLANTS MORE ON RIGHT LEG, VERY LITTLE ON LEFT LEG. A FOREIGN BODY REACTION WAS SUSPECTED. HARDWARE WAS REMOVED ON 9/5/96. PLATE FROM RIGHT LEG HAD SOME BROWNISH DISCOLORATION OBSERVED BY SURGEON. TISSUE ON RIGHT SIDE ALSO HAD SOME DISCOLORATION. NO REPLACEMENT DEVICES IMPLANTED. PT HEALING SATISFACTORALLY. THIS TYPE OF EVENT IS OCCURRING BELOW THE FREQUENCY AND SEVERITY THAT ARE USUAL FOR THESE DEVICES.
INFO OBTAINED FROM THE PT'S OPERATIVE REPORT AND PICTURES OF THE EXPLANTED BONE PLATES CONFIRMS THAT PT RECEIVED TWO BONE PLATES: ONE PLATE WAS MFG FROM AESCULAP AND ONE PLATE WAS MFG FROM SYNTHES (CATALOG NUMBER 241.05). THE AESCULAP 8-HOLE BONE PLATE APPEARS TO HAVE BEEN CUT DOWN TO A 6-HOLE PLATE LENGTH BY THE USER. THE PT HAS FILED A LAWSUIT AGAINST AESCULAP AS A RESULT OF THIS EVENT. AS FURTHER INFO BECOMES AVAILABLE, AESCULAP WILL SUBMIT ANOTHER FOLLOW-UP REPORT.
IMPLANTS REMOVED. RIGHT WITH LEAK; LEFT RUPTURED.
THE DEVICE WAS USED DURING AN ECTOPIC PREGNANCY PROCEDURE. IT WAS REPORTED THE EZ35W WAS USED TO LIGATE AND DIVIDE THE FALLOPIAN TUBE NEAR ECTOPIC. IN THE FIRST FIRING, A LOUD, "CRUNCH" WAS HEARD AND THE INSTRUMENT WOULD NOT RELEASE FROM ADNEXA. A MINI LAP WAS PERFORMED AND THE INSTRUMENT WAS EXCISED FROM THE PT. THE DEVICE IS TO BE SENT TO THE HOSP RISK MANAGER.
A1,2,3,4;B6,7;D10: INFO UNAVAILABLE. D5,6;H4,6: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
DURING LT TOTAL HIP, BROACH INSERTER AND EXTRACTOR BROKE DURING USE INSIDE FEMORAL CANAL. BROKEN PIECE ACCOUNTED FOR INSIDE BROACH. BOTH PIECES GIVEN TO SALES REP ON 8/22.
THE DEVICE WAS IMPLANTED ON 8/27/96 FOR SUBCLAVIAN INFUSION OF DEMEROL AND VALIUM. ON 9/5/96, THE FACILITY I.V. TEAM SUPERVISOR CONTACTED THE MFR SALES REPRESENTATIVE AND REPORTED THAT THE PT HAD STARTED TO RECEIVE POST OEPRATIVE THERAPY. SEVERAL HOURS AFTER THERAPY WAS STARTED, IT WAS NOTED THAT INFILTRATION WAS OCCURRING IN THE NECK REGION ABOVE THE DEVICE; HOWEVER, NOT UNTIL LARGE AMOUNTS OF DRUG HAD BEEN INFUSED. A MFR'S INFUSION SET (POSSIBLY THE ONE INCLUDED WITH DEVICE) WAS SENT WITH THE PT AND WAS USED TO ACCESS THE DEVICE. THE DEVICE INFUSION SET "WINGS" HAD NOT BEEN TAPED DOWN AND AN OCCLUSIVE DOSAGE WAS IN PLACE.
ON 11/22/96, THE MFR CONTACTED THE FACILITY'S I.V. TEAM SUPERVISOR TO OBTAIN FOLLOW UP INFORMATION CONCERNING THIS PATIENT/DEVICE. THE I.V. TEAM SUPERVISOR REPORTED THAT THE DEVICE HAS SINCE BEEN ACCESSED AND NO FURTHER DIFFICULTIES ARE BEING EXPERIENCED. IN ADDITION, THE I.V. TEAM SUPERVISOR STATED THAT THIS EVENT HAD OCCURRED DUE TO THE NEEDLE PULLING OUT OF THE DEVICE SEPTUM DURING THE INFUSION PROCEDURE. THE DEVICE IS PERFORMING AS INTEND AND WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN. BASED ON THIS INFORMATION, THIS EVENT DOES NOT APPEAR TO HAVE BEEN RELATED TO A DEVICE MALFUNCTION OR FAILURE. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
SPRING IN THE LV SUMP SOMEHOW BECAME SEPARATED AND GOT SOME TISSUE STUCK IN BETWEEN THE ROLLS OF THE SPRING. THE UNIT WAS PULLED APART AND THE BULLET TIP WAS REMOVED. WHEN THE PT WAS WEANED FROM BYPASS, AND THE ECHO WAS REVIEWED, THERE WAS A LOT OF MITRAL REGURGITATION NOTED. THE PT WAS PLACED BACK ON BYPASS AND THE MV WAS REPLACED. THE SURGEON DID NOT IMPLICATE THE CANNULA AS THE CAUSE FOR REPLACING THE MITRAL VALVE. PT IS DOING WELL.
PER THE CONTRAINDICATIONS LISTED IN THE PRODUCT'S DIRECTIONS FOR USE THE PERICARDIAL CARDIAC SUMP IS NOT INTENDED TO BE PLACED THROUGH A PT'S VALVE LEAFLETS TO DRAIN A CLOSED CARDIAC CHAMBER. VALVE DAMAGE MAY OCCUR IF THE PERICARDIAL SUMP IS PASSED THROUGH THE VALVE LEAFLETS. ON THIS COMPLAINT, IT APPEARS AS IF THIS PRODUCT WAS USED IN A UNINTENDED MANNER.
FIRST PROCEDURE WAS AT 8:00 AM. RIGHT HEMI-COLECTOMY DUE TO ADENO-CARCINOMA. RECTAL BLEEDING POST-OP REQUIRED RE-ADMITTANCE TO THE O.R. AT 1:55 PM. INSPECTION OF OUTSIDE OF ILEO-COLOTIC ANASTOMSIS REVEALED NO BLEEDING. ANATOMSIS WAS DISMEMBERED AND A HAND ANASTOMSIS WAS PERFORMED. THE COLOTOMY WAS ALSO RE-DONE BY HAND SUTURES WITH 3/0 SUTURES. PT WAS THEN DISCHARGED ON 7/26/96.
10/2/96 MEDTWATCH REPORT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. THE HOSP HAS REPORTED THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.
SCREW FELL OUT OF INSTRUMENT INTO PT INCISION DURING A LEFT L2-L3 MICROLUMBAR CASE. SCREW WAS LOCATED AND REMOVED BY PHYSICIAN.
THE INSTRUMENT WAS USED DURING A PNEUMONECTOMY. IT WAS REPORTED DURING A PNEUMONECTOMY WITH THE FIRST FIRING OF THE DEVICE STAPLE LINE BLEEDING OCCURRED AT BOTH ENDS OF THE DISTAL STAPLE LINE (SPECIMEN SIDE). THE PT RECEIVED ONE UNIT OF BLOOD DURING THE PROCEDURE, PARTIALLY DUE TO STAPLE LINE BLEEDING. PROCEDURE COMPLETED WITH 1 MORE SUCCESSFUL STAPLE FIRE AND SUTURE OVERSEW.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING WITH REGARD TO STAPLES FIRING AND FORMING. THE INSTRUMENT WAS RECEIVED IN GOOD PHYSICAL CONDITION AND THERE WAS NO CARTRIDGE RETURNED. A RELOAD CARTRIDGE WAS LOADED ON THE INSTRUMENT AND WAS CYCLED, FIRED AND PROPERLY FORMED THE STAPLES. THE STAPLES WERE FOUND TO BE WITHIN SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT DURING SURGERY. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FIRE AND FORM CORRECTLY. THE STAPLES MAY NOT FORM PROPERLY AND LEAKAGE OF THE STAPLE LINE MAY OCCUR IF THE INSTRUMENT IS CLOSED ONTO TISSUE WHICH IS THICKER THAN THE RECOMMENDATION FOR PROPER OPERATION. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
PT HAD A LAMINECTOMY WHERE SPN WAS USED. SEVERAL MONTHS POSTOPERATIVELY THE PT'S SYMPTOMS RETURNED. THE SURGEON REOPERATED TO REMOVE A RECURRENT DISC FRAGMENT. AT REOPERATION, THE SURGEON HAD DIFFICULTY REMOVING THE MEMBRANE AND GAINING ACCESS TO THE OPERATIVE SITE.
THE DEVICE WAS NOT RETURNED TO CO FOR EVALUATION; THEREFORE, NO CODES WERE COMPLETED FOR METHOD AND RESULTS.
DURING TRANSFER OF RESIDENT FROM BED TO WHEELCHAIR, RESIDENT'S LEG WAS CUT ON PROTRUDING LIP OF WHEELCHAIR LEGS.
THIS EVENT WAS REPORTED AS UNK. NO FURHTER INFO PROVIDED.
A NASAL ASPIRATOR WAS USED INCORRECTLY TO SUCTION A CHILD'S MOUTH. THE TIP OF THE ASPIRATOR BECAME LOOSE AND WAS CAUGHT IN THE CHILD'S THROAT. THE TIP WAS REMOVED BY MEDICAL PERSONNEL.
DURING TRANSFER TO WHEELCHAIR, RESIDENT'S LEG WAS CUT ON EDGE OF LIP ON FOOTREST.
CODE 86: EVALUATION BASED ON HISTORY OF DEVICE MFG AND QC PROCEDURES AND CONTENT OF EVENT DESCRIPTION. THIS PRODUCT EVENT WAS RECEIVED AS CUSTOMER COMPLAINT. DEVICE WAS USED FOLLOWING DIAGNOSTIC CATHETERIZATION WITH NO COMPLICATIONS. IN RECOVERY, PT HAD VENOUS BLEED. STERILE TECHNIQUE WAS NOT USED DURING TREATMENT. FOUR DAYS LATER PT WAS ADMITTED WITH INFECTION REQUIRING I&D AND ANTIBIOTICS. PT DISCHARGED IN SEVERAL DAYS WITH NO FURTHER COMPLICATIONS.
THIS EVENT WAS REPORTED AS UNK. NO FURTHER INFO PROVIDED.
H3: EVALUATION OF THE VALVE IN CO LABORATORY REVEALED HOST TISSUE OVERGROWTH HAD FUSED EACH COMMISSURE AND EACH ATTACHMENT SITE RESULTING IN STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS INCLUDING DETACHMENT OF EACH LEAFLET, AND INCOMPLETE COAPTATION. MECHANICAL INJURIES WERE NOTED ON THE STENT POST BETWEEN THE RIGHT AND LEFT - CORONARY CUPS AND APEARED ARTIFACTUAL OF EXPLANT. X-RAY ANALLYSIS REVEALED MINOR FOCI OF CALCIFICATION WITHIN THE AORTIC WALL OF THE LEFT AND NONCORONARY CUSPS. SLIGHT DISTORTION OF THE STENT WAS NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO HOST TISSUE OVERGROWTH.
THIS EVENT WAS REPORTED AS RECURRENT ISCHEMIA, DILATATION OF THE ANNULUS FROM AORTIC VALVE, "FAILED PORCINE HETORGRAFT" AND INSUFFICIENCY.
SALES REP CALLED IN THE COMPLAINT STATING THAT THE CONSTRUCT HAS LOOSENED. NO SURGICAL INTERVENTION HAS BEEN PERFORMED AS OF THE DATE OF THIS REPORT. X-RAYS WERE RECEIVED AND EVALUATED. FROM THE POST-OP FILMS, EVIDENCE DOES APPEAR TO INDICATE THAT THE DEVICE MAY NOT HAVE BEEN ADEQUATELY TIGHTENED AT THE TIME OF THE SURGERY. THE REP. STATED, AT THE TIME THE COMPLAINT WAS FILED, HE BELEIVES THE SURGEON MAY NOT HAVE ADEQUATELY TIGHTENED THE CONSTRUCT. THE SURGEON STATED, IN A FOLLOWING PHONE CONVERSATION, THAT HE IS AWARE THAT THE CONSTRUCT HAS LOOSENED BUT DOES NOT INTEND TO PERFORM SURGICAL INTERVENTION UNLESS THE PT COMPLAINS. THE DR. STATED, "I TREAT THE PTS, NOT THE X-RAYS".
LETTER TO SURGEON PROVIDING INFORMATION REGARDING DEVICE TESTING PRIOR TO MARKET RELEASE. INFORMATION VERIFIES NO FAILURE TO DEVICE DURING TESTS. SPECIFIC INFORMATION REGARDING FASTENERS OF THE DEVICE WHICH INDICATED NO SIGNS OF FASTENERS LOOSENING DURING TESTING. INFORMATION DETAILS DEVIATION OF LOOSENING TORQUE OF THE FASTENERS. MFR TESTED THE DEVICE ACCORDING TO FDA GUIDELINES, ASTM PROVISIONAL STANDARD F-04.35.1 "STATIC AND FATIGUE TEST METHODS FOR SPINAL IMPLANT CONSTRUCTS IN A CORPECTOMY MODEL", AND SUBMITTED THE TEST DATA IN OUR 510K SUBMISSION. THE TESTING ESTABLISHED MUCH VALUABLE AND QUALITATIVE DATA. THE CONSTRUCT WAS TESTED AS A CORPECTOMY MODEL SIMULATING AN S1/L4 SKIP. TWO FINAL SUBSTANTIVE TESTS WERE RUN-OUT TO 5 MILLION CYCLES WITHOUT FAILURE. ADDITIONALLY, TESTING OF THE CONSTRUCT WAS PERFORMED UNDER CORPECTOMY MODEL CONDITIONS ACCORDING TO PROCEDURE. THE HEX BOLT FASTENERS FOR THE DEVICE WERE TORQUED (RECORDED), THE TEST INITIATED AND ONCE THE TEST WAS COMPLETE THE REMOVAL TORQUE OF EACH FASTENER WAS MEASURED AND RECORDED. THE LOOSENING TORQUE STANDARD DEVIATION FOR THE FATIGUE TESTING WAS ONLY .29 N-M )2.5 INCHES LBS.) AVERAGE FOR THE 12 FASTENERS USED IN TESTING. WHILE IT IS YET INCONCLUSIVE WHY THE CONSTRUCT MAY HAVE LOOSENED IN THE ABOVE MENTIONED PATIENT, MFR BELIEVES THIS DATA MAY BE INFORMATIVE.
THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON MANUALLY PERFORMED A COLOSTOMY TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THE PT'S STATUS IS SATISFACTORY. DATE DEVICE IMPLANTED: 3/31/2000.
10/2/96 MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
THIS EVENT WAS REPORTED AS STENOSIS. NO FURTHER INFO PROVIDED.
THIS REPORT WAS REPORTED AS "DEGENERATION", AND INSUFFICIENCY. NO FURTHER INFO PROVIDED.
THE CONSTRUCT HAS LOOSENED. NO SURGICAL INTERVENTION HAS BEEN PERFORMED AS OF THE DATE OF THIS REPORT. X-RAYS WERE REC'D AND EVALUATED. FROM THE FILMS WHICH WERE TAKEN POST-OPERATIVELY, EVIDENCE DOES INDICATE THAT THE DEVICE MAY NOT HAVE BEEN ADEQUATELY TIGHTENED AT THE TIME OF SURGERY. THE REP STATED, AT THE TIME OF SURGERY, SURGEON MAY NOT HAVE ADEQUATELY TIGHTENED THE CONSTRUCT. THE SURGEON HAS STATED, IN PHONE CONVERSATION, THAT HE IS AWARE THAT THE CONSTRUCT HAS LOOSENED BUT DOES NOT INTEND TO PERFORM SURGICAL INTERVENTION UNLESS THE PT COMPLAINS. THE DR. STATED, "I TREAT THE PTS, NOT THE X-RAYS".
LETTER TO SURGEON PROVIDING INFORMATION REGARDING DEVICE TESTING PRIOR TO MARKET RELEASE. INFORMATION VERIFIES NO FAILURE TO DEVICE DURING TESTING. SPECIFIC INFORMATION REGARDING FASTENERS OF THE DEVICE WHICH INDICATED NO SIGNS OF FASTENERS LOOSENING DURING TESTING, INFORMATION DETAILS DEVIATIONS OF LOOSENING TORQUE OF THE FASTENERS. MFR TESTED THE DEVICE ACCORDING TO FDA GUIDELINES, ASTM PROVISIONAL STANDARD F-04.35.1 "STATIC AND FATIGUE TEST METHODS FOR SPINAL IMPLANT CONSTRUCTS IN A CORPECTOMY MODEL", AND SUBMITTED THE TEST DATA IN OUR 510K SUBMISSION. THE TESTING AS A CORPECTOMY MODEL SIMULATING AN S1/L4 SKIP. TWO FINAL SUBSTANTIVE TESTS WERE RUN-OUT TO 5 MILLION CYCLES WITHOUT FAILURE. ADDITIONALLY, TESTING OF THE CONSTRUCT WAS PERFORMED UNDER CORPECTOMY MODEL CONDITIONS ACCORDING TO PROCEDURE. THE HEX BOLT FASTENERS FOR THE DEVICE WERE TORQUED (RECORDED), THE TEST INITIATED AND ONCE THE TEST WAS COMPLETE THE REMOVAL TORQUE OF EACH FASTENER WAS MEASURED AND RECORDED. THE LOOSENING TORQUE STANDARD DEVIATION FOR THE FATIGUE TESTING WAS ONLY .29 N-M (2.5 INCH LBS.) AVERAGE FOR THE 12 FASTENERS USED IN TESTING. WHILE IT IS YET INCONCLUSIVE WHY THE CONSTRUCT MAY HAVE LOOSENED IN THE ABOVE MENTIONED PATIENT, MFR BELIEVES THIS DATA MAY BE INFORMATIVE.
ACTIVATD SECOND CUFF AND REPLACED TWO CONNECTORS DUE TO RECURRING INCONTINENCE.
OLYMPUS AMERICA INC REC'D A COPY OF THE AUTOPSY REPORT ON THE DECEASED FEMALE. IN THE OPINION OF THE FORENSIC PATHOLOGIST, THE DECEDENT CAME TO HER DEATH AS A RESULT OF PERFORATED ABDOMINAL AORTA WITH MASSIVE HEMOPERITONEUM, THERAPEUTIC MISADVENTURE, ACCIDENTAL. THE COMPLETE AUTOPSY REPORT WILL BE FURNISHED UPON REQUEST.
(IAB S/N UNK) THE HEMOSTASIS VALVE LEAKED EXCESSIVELY AS IF THERE WAS NO VALVE. THE IAB WAS USED WITHOUT ANY FURTHER PROBLEMS. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE VALVE WAS DISCARDED BY THE FACILITY.
A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFR. IT WAS NOT DETERMINED UNTIL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96, THAT THIS WAS A 5 DAY REPORTABLE MDR. THEREFORE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILIAR COMPLAINTS WILL BE REPORTED WITHIN 5 WORKING DAYS.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CUFF HOLE.
GUIDE WIRE WAS USED THROUGH A ENTRY NEEDLE. A PIECE OF THE WIRE DETACHED IN THE PT AND REMAINED IN THE LEFT PROFUNDA ARTERY. RETRIEVAL UTILIZING A SNARE WAS UNEVENTFUL.
(IAB S/N UNK) THE HEMOSTASIS VALVE ON THE END OF THE SHEATH BECAME LOOSE. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE VALVE WAS DISCARDED BY THE FACILITY.
A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFR. IT WAS NOT DETERMINED UNITL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96 THAT THIS WAS A 5 DAY REPORTABLE MDR. THEREFORE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILIAR COMPLAINTS WILL BE REPORTED WITHIN 5 WORKING DAYS.
THE REPORTER, DIAGNOSED AS A TYPE I DIABETIC 16 YEARS AGO WAS TRANSPORTED BY EMS TO THE HOSP AND TREATED WITH UNK IV MEDICATION AND FOOD FOR LOW BLOOD SUGAR AND SEIZURE ("EPILEPTIC FIT"). THE PT'S BLOOD SUGAR AFTER TREATMENT WAS 93. PRIOR TO THE INCIDENT, THE PT TOOK 10 UNITS OF INSULIN AFTER OBTAINING A READING OF 305 WITH THE SUSPECT DEVICE. THE PT ADJUSTS HIS INSULIN DOSAGE ON HIS OWN, DEPENDING ON THE DEVICE RESULT. THE PT REPORTS THAT IN A COMPARISON WITH HIS PHYSICIAN'S DEVICE (RESULT OF 482) THE SUSPECT DEVICE GAVE 567.
EVALUATION BASED ON HISTORY OF DEVICE MFG OF EVENT DESCRIPTION. PRODUCT WAS USED FOLLOWING A STENT PROCEDURE. SHEATH PULL WAS DELAYED 4-8 HOURS. TWO DAYS POST PROCEDURE, PT WAS SEEN AT ANOTHER HOSP. THE FOLLOWING INFO WAS NOT PROVIDED BY THE TREATING HOSP, BUT BY THE FELLOW AND MD THAT PERFORMED THE PROCEDURE. THEREFORE, THE ACCOUNT IS SECOND HAND. IT WAS REPORTED THAT THE PT HAD A FEVER, PARTIAL BODY RASH AND DESQUAMATION OF THE PALMS. THE GROIN WHERE PRODUCT WAS USED WAS NOT INFLAMED, BUT THERE WAS SCANT NONPURULENT DRAINAGE FROM THE SITE. SURGERY CONSULT FELT THE GROIN WAS NOT INFECTED BUT CULTURES SHOWED A SMALL AMOUNT OF STAPH THAT MAY HAVE BEEN THE SOURCE OF TOXINS. BLOOD CULTURES WERE NEGATIVE. THE DR THOUGHT THESE SYMPTOMS INDICATED TOXIC SHOCK SYNDROME. NO FURTHER INFO WAS AVAILABLE. THE PT WAS TREATED WITH ANTIBIOTICS FOR 5 DAYS AND RELEASED. TWO WEEKS LATER THE PT EXPERIENCED CHEST PAIN AND DIED. THE PHYSICIAN FELT THE DEATH WAS NOT RELATED TO PRODUCT. CODE 68: ALTHOUGH THE LOT NUMBER OF THIS PARTICULAR LOT OF PRODUCT WAS NOT AVAILABLE, THE MFG AND CO PROCEDURES CONFIRM THE STERILITY OF DEVICE. THE FACT THE GROIN DID NOT APPEAR TO BE INFECTED INDICATES THAT USE OF PRODUCT HAD NO CAUSAL RELATIONSHIP TO THIS EVENT.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE-ATROPHY.
MD REPORTED THAT HE HAD KNOWLEDGE OF THREE CASES IN WHICH THE PT'S ESOPHAGUS WAS RUPTURED DUE TO NEGLIGENT USE OF THE LARYGEAL MASK AIRWAY. OF THE THREE CASES, ONE PT HAD RECOVERED, ONE PT EXPERIENCED BRAIN DAMAGE (DEGREE UNKNOWN), AND ONE PT DIED. THE RPTR INDICATED THAT THE EVENTS WERE NOT DUE TO A DEVICE MALFUNCTION BUT TO MISUSE BY THE HEALTH CARE PRACTITIONER(S) INVOLVED. A THOROUGH LITERATURE SEARCH DID NOT REVEAL ANY SIMILAR CASES. THE MFR ALSO CONDUCTED A LITERATURE SEARCH IN A DATABASE WHICH INCLUDES ALL OF THE MAJOR EUROPEAN AND INTERNATIONAL ANESTHESIA JOURNALS USING OESOPHAGEAL RUPTURE AS THEIR PARAMETER.
(IAB S/N UNK) THE CLEAR HEMOSTASIS VALVE LEAKED DURING INSERTION. THE VALVE WAS ACCIDENTLY UNSCREWED. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE VALVE WAS DISCARDED.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO CUFF WAS TOO BIG.
THE VALVE WAS REMOVED DUE TO REGURGITATION. CUSPAL STRETCHING WAS NOTED AT EXPLANT. "THERE WAS DEFINITELY NO PARAVALVULAR LEAK, SO THE REGURGITATION MUST HAVE BEEN TRANSVALVULAR WHICH IS A FUNCTIONAL OBSERVATION".
H10. "SUBMISSION OF INFO BY CO UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGUALTION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED". EVALUATION RESULTS CODE #100 OTHER = DEVICE WAS RETURNED WITH LEAFLET DISSECTION AND STEND DISTORTED, FAILURE COULD NOT BE REPRODUCED. NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY THEREFORE, INFO ON THIS MEDWATCH FORM 3500A WAS COMPLETED BY CO WITH INFO RECEIVED FROM THE HEALTHCARE PROFESSIONAL. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A. H3 ANALYSIS: LEAFLET TISSUE SECTION WAS TAKEN PRIOR TO RETURNING THE PRODUCT AND DISTORTION OF THE STENT WAS PRESENT DUE TO DAMAGE DURING EXPLANT. THERE WAS NO EVIDENCE OF CUSPAL STRETCHING AND THE RADIOGRAPH SHOWS THE VALVE TO BE FREE OF MINERALIZATION. THE FAILURE COULD NOT BE REPRODUCED THEREFORE, THE CAUSE OF THE EVENT IS UNKNOWN.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION.
DEVICE LABEL CODES: 1738. EVALUATION SUMMARY: EVALUATION: A CLEAR HEMOSTASIS VALVE WAS RETURNED FOR EVALUATION. NO BLOOD WAS NOTED ON THE EXTERIOR OF THE DEVICE. USING A LABORATORY IAB AND SHEATH, THE HEMOSTASIS VALVE WAS LEAK TESTED IN ORDER TO DETERMINE IF THE VALVE ASSEMBLY PROHIBITED THE BACK FLOW OF WATER THROUGH THE VALVE GASKET INTO THE STAT-GARD. THE ASSEMBLY PASSED THIS LEAK TEST. VISUAL EXAMINATION OF THE VALVE GASKET REVEALED IT TO BE SLIGHTLY STRETCHED. A LABORATORY .030" GUIDEWIRE WAS LOOSE WITHIN THE GASKET. PROBABLE CAUSE OF DIFFICULTY: NO DEFECT WAS FOUND IN THE SHEATH/HEMOSTASIS VALVE ASSEMBLY DURING LABORATORY EXAMINATION. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTY IN THE LAB. IT WAS REPORTED THAT THE LEAK OCCURRED WHEN THE DILATOR AND GUIDEWIRE WERE REMOVED, BUT THE LEAK STOPPED WHEN THE CATHETER WAS FULLY INSERTED THROUGH THE VALVE. PRIOR TO THE BALLOON'S INSERTION THROUGH THE SHEATH/HEMOSTASIS VALVE ASSEMBLY, IT IS QUITE NORMAL FOR BLOOD TO SEEP EITHER THROUGH THE SMALL HOLLOW BARREL OF THE BLUE DILATOR - WHICH IS IN PLACE THROUGH THE HEMOSTASIS VALVE OR THROUGH THE SMALL HOLE IN THE HEMOSTASIS VALVE GASKET - WHEN THE DILATOR IS REMOVED (EVEN WITH THE GUIDEWIRE IN PLACE). THIS SEEPAGE OF BLOOD SHOULD BE EXPECTED AND SHOULD NOT BE CONSIDERED A PRODUCT DEFECT. ONCE THE BALLOON IS INSERTED OVER THE GUIDEWIRE AND THE CATHETER TUBING IS PASSED THROUGH THE HEMOSTASIS VALVE ASSEMBLY, THE VALVE GASKET CREATES A TIGHT SEAL AGAINST THE CATHETER WALL TO PREVENT BLOOD FROM PASSING INTO THE STAT-GARD VIA THE SHEATH SEAL. SINCE THE VALVE DID NOT LEAK DURING LAB TESTING AT DATASCOPE, IS IT POSSIBLE THAT THE USER PERCEIVED THE INITIAL SEEPAGE (PRIOR TO CATHETER INSERTION) TO BE THE LEAK. FINALLY, IT IS WORTH NOTING THAT THE NATURE OF EACH LEAK, AS PERCEIVED BY THE USER, WOULD NOT HAVE JEOPARDIZED BALLOON FUNCTION IF THE DECISION WAS MADE TO USE THE VALVE DURING IABP. ANY BLOOD PASSING THROUGH THE HEMOSTASIS VALVE CAN BE PREVENTED FROM ENTERING INTO THE STAT-GARD VIA THE SHEATH SEAL IF A LIGATURE IS TIED AROUND THE GROOVE IN THE STAT-GARD WING.
EVENT COMPLICATIONS: UNK - REPORTED 9/24/96; NONE - REPORTED 10/18/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 9/24/96.
THE PT WAS SCHEDULED FOR A LEAD REVISION ON 9/12/96, DUE TO PACING LEAD IMPEDANCE PROBLEMS WITH THE PACING LEAD WHICH HAD BEEN IMPLANTED ON 7/22/92. THE PACING LEAD IMPEDANCE VARIED BETWEEN 900 OHMS AND 1300 OHMS. THE LEAD WAS CAPPED AND LEFT IN THE PT.
ON 12/2/86 AN AUS DEVICE WAS IMPLANTED. ON 5/13/93 THE PUMP WAS REVISED. ON 8/27/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A LEAK AT TUBING PUMP JUNCTION.
CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS. PUMP TUBING JUNCTION HAD A FATIGUE LEAK.
REPORTER ALLEGES PT RECEIVED BREAST IMPLANTS IN SEPT, 1985. REPORTER ALSO ALLEGES PT'S IMPLANTS WERE REMOVED ON AUG 26, 1996 BY PT'S REQUEST DUE TO CONTINUING PAIN AND CONCERN. REFERENCE MEDWATCH #1009814.
(IAB S/N UNK) THERE WAS ALOT OF BLEEDING FROM THE CLEAR SHEATH/HEMOSTASIS VALVE. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE VALVE WAS DISCARDED BY THE FACILITY.
A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFR. IT WAS NOT DETERMINED UNTIL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96, THAT THIS WAS A 5 DAY REPORTABLE MDR. THEREFORE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILIAR COMPLAINTS WILL BE REPORTED WITHIN 5 WORKING DAY.
A PEDIATRIC PT WAS IN THE OPERATING ROOM BEING MONITORED. THE STAFF WAS HAVING PROBLEMS WITH THE MONITOR WHEN THE PT CODED. THE CO2, PULSE OX, AND INVASIVE BP WERE SHOWING QUESTION MARKS. THE KEY WAS CYCLING TRYNG TO OBTAIN A PRESSURE. THE PT WAS TRANSFERRED TO PEDIATRIC ICU. THE CURRENT STATUS OF THE PT IS UNKNOWN.
CE WENT TO THE SITE AND INSPECTED THE COMPONENT MONITORING SYSTEM. THE SYSTEM WAS WORKING PROPERLY. THE MONITOR WAS BEING USED IN ADULT MODE WHEN THE INCIDENT HAPPENED, BUT IT WAS DETERMINED THAT THIS WOULD NOT HAVE CAUSED A MONITORING PROBLEM ON A PEDIATRIC PT. ERROR CODE 24088 WAS FOUND IN THE SERVICE TASK WINDOW. THIS ERROR IS A NON-FATAL THAT OCCURS WHEN THE REQUEST FOR A REPORT IS DONE TOO SOON AFTER THE END OF CASE REQUEST. IT IS ASSOCIATED WITH A HARD COPY PRINTOUT OF THE PT'S VITAL SIGNS AFTER THE END OF THE CASE. THE CORRECTIVE ACTION FOR THIS ERROR, AS IDENTIFIED IN THE SERVICE MANUAL, IS "IGNORE." THIS ERROR HAS NO IMPACT ON THE INFO DISPLAYED ON THE SCREEN DURING NORMAL MONITORING MODE. QUESTION MARKS FOR A PARTICULAR PARAMETER MAY BE CAUSED BY MANY REASONS AS DEFINED IN THE USER'S REFERENCE MANUAL. WHEN QUESTION MARKS ARE DISPLAYED, A PROMPT DISPLAYING THE CAUSE IS SHOWN IN THE UPPER LEFT HAND PART OF THE DISPLAY. THESE MESSAGES ARE NOT LOGGED. THE HOSP HAS NOT PROVIDED CO WITH INFO AS TO THE CAUSE DISPLAYED. ADDITIONALLY, THE TREND DATA REPORT HAS NOT BEEN MADE AVAILABLE TO CO. IN SOME CASES, THE PT'S CONDITION WILL MAKE NIBP MEASUREMENT IMPOSSIBLE. CO DOES NOT KNOW IF THE PT HAD ANY OF THESE  CONDITIONS WHICH ARE STATED IN THE USER'S REFERENCE MANUAL AS FOLLOWS: PT MOVEMENT, CARDIAC ARRHYTHMIAS, HEART-LUNG MACHINE, PRESSURE CHANGES, SEVERE SHOCK, HEART RATE EXTREMES, OBESE PTS.
ADDITIONAL INFO WAS RECEIVED FROM REPORTER ON 10/3/96. ORIGINAL REPORT WAS RECEIVED BY MFR ON 9/6/96.
SURGEON REPORTS PATIENT HAD VITREOUS HEMORRHAGE ANDHEMA DOCUMENTED ON 7/3/96 AFTER LEFT PHACO AND PC IOL SURGERY ON 6/25/96. OBSERVED UNTIL 8/30/96 BECAUSE OF MEDICAL STATUS BUT VITREOUS HEMORRHAGE REMAINED VERY DENSE; ANTERIOR SEGMENT CLEARED. VITRECTOMY PERFORMED TO REMOVE VITREOUS HEMORRHAGE. DURING SURGERY UNABLE TO VIEW RETINA AFTER 30 MINS. OF VITRECTOMY AND WASHOUT. LENS CAPSULTOMY PERFORMED AND CORNEAL EPITHELIUM REMOVED, STILL NO VIEW. PC IOL ULTIMATELY NEEDED TO BE REMOVED AFTER WHICH VIEW OF THE RETINA CLEARED. AC IOL PLACED. THE IOL WHICH WAS REMOVED WAS NOTED TO BE STAINED, COATED, IMBEDDED WITH HEME WHICH COULD NOT BE REMOVED OR SCRAPED OFF WHILE IOL STILL IN EYE.
LAP SPONGE APPARENTLY LEFT IN PT FOLLOWING AAA REPAIR. LAP SPONGE DISCOVERED ON CT SCAN AND PT TAKEN TO SURGERY ON 8/16/96 FOR REMOVAL. PRIOR TO REMOVAL, PT C/O RIGHT LOWER QUADRANT PAIN FOR APPROX ONE WEEK. ADMITTED FOR RIGHT PELVIC ABCESS. FOLLOWING REMOVAL, PT HAS RECOVERED WELL.
DURING A CATARACT EXTRACTION PROCEUDRE, THE BIPOLAR FUNCTION WOULD NOT WORK. ANOTHER SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETE BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
ADULT FEMALE CONSUMER USED PRODUCT IN EAR CANAL. CONSUMER ALLEGES THAT BUD CAME OFF IN EAR. PHYSICIAN REMOVED FROM EAR.
F10: PT 2199. DEVICE 1670 1506. LABELING: LABELING CAUTIONS AGAINST USE IN THE EAR CANAL AND THAT IMPROPER USE CAN CAUSE INJURY. F 12: HOME. CO REC'D ONE SWAB FROM THE CUSTOMER THAT HAD NO BUD OR SERRATIONS ON ONE END. THE SWAB WAS CRUSHED AS THOUGH IT HAD BEEN RUN THROUGH A MAIL SORTING MACHINE. THE SWAB WAS NOT SUITABLE FOR TESTING HOWEVER IT DID NOT MEET THE REQUIREMENT FOR HAVING SERRATIONS. WITH THE ABSENCE OF A VALID DATECODE NO FURTHER TESTING COULD BE PERFORMED. THIS TYPE OF COMPLAINT IS MONITORED AND HAS REC'D SIGNIFICANT RESOURCE FOCUS TO REDUCE AND HOPEFULLY TO ELIMINATE THE ISSUE. THE FOLLOWING CORRECTIVE ACTIONS ARE EXAMPLES OF WHAT IS BEING DONE TO REDUCE THE COMPLAINT. A TEAM HAS BEEN WORKING TO IDENTIFY THE FAILURE MODES THAT MAY CREATE A SWAB WITHOUT SERRATIONS ON THE TWO DIFFERENT TYPES OF MACHINES IN THE SWAB DEPT. ON THE CASE TYPE MACHINE THE FAILURE MODE WAS IDENTIFIED WHERE A MACHINE COULD COAST DOWN TOO SLOWLY ON A STOP, ALLOWING SEVERAL STICKS TO PASS THROUGH THE SERRATION AREA AFTER THE SERRATING JAWS HAD OPENED. THIS HAS BEEN CORRECTED THROUGH OPERATOR AWARENESS AS WELL AS ADJUSTMENTS TO THE PNEUMATIC BRAKING SYSTEM. ON THE VERSA TYPE MACHINES VARIOUS MACHINE MODIFICATIONS HAVE BEEN PERFORMED TO PREVENT SWAB STICKS FROM PASSING THROUGH THE SERRATING AREA OF THE MACHINE WITHOUT BEING SERRATED OR WITHOUT RECEIVING A REDUCED NUMBER OF SERRATIONS. THE DIRECTION OF THE TREND INDICATES THAT THE CORRECTIVE ACTION IS HAVING A POSITIVE IMPACT.
DURING A CATARACT EXTRACTION PRODECURES, THERE IS AN INTERMITTENT PROBLEM WITH THIS UNIT WHERE THE CASSETTE WOULD NOT EJECT. THE MOST RECENT EVENT BEING 8/14/96. WHEN THIS PROBLEM OCCURS, THE UNIT IS REACTIVATED.
(IAB S/N UNK) WHEN THE INTRODUCER DILATOR ASSEMBLY AND THE CLEAR HEMOSTASIS VALVE ASSEMBLY SEPARATED FROM THE SHEATH HUB, THE HEMOSTASIS VALVE LEAKED. IABP CONTINUED WITHOUT FURTHER PROBLEMS. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE VALVE WAS DISCARDED BY THE FACILITY.
A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFR. IT WAS NOT DETERMINED UNTIL SAFETY ALERT LETTER WAS SIGNED ON 9/27/96, THAT THIS WAS A 5 DAY REPORTABLE MDR. THEREFORE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILIAR COMPLAINTS WILL BE REPORTED WITHIN 5 WORKING DAYS.
REPORT STATES PT RECEIVED A LEFT IMPLANT AUG 27, 1990. REPORT ALSO STATES PT'S SYMPTOMS WERE OBVIOUS BY APRIL, 1994 AND SHE WAS DIAGNOSED IN NOV, 1994 WITH ACQUIRED CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULAR NEUROPATHY AND SEVERE SENSORY MOTOR AND AUTONOMIC NERVE DAMAGE. PT HAD REMOVAL IN AUG, 1994 OR ON AUG 24, 1996. REFERENCE MEDWATCH 1009777.
D2 - STATES SALINE BREAST IMPLANT AND D6 STATES CO'S GEL PROSTHESIS AND THE CATALOG NUMBER (P0150600) CONFIRMS THE DEVICE IS A SILASTIC II GEL. D8 - TWO DIFFERENT EXPLANTDATES WERE PROVIDED (AUG, 1994 AND AUG 24, 1996) AND CO IS UNSURE WHICH DATE IS CORRECT. D9 - THE DEVICE IS AVAILABLE FOR EVAL; HOWEVER, CO IS UNABLE TO REQUEST DEVICE DUE TO PT ANONYMITY. CONCLUSION: 68 OTHER (NO DEVICE RETURNED).
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATON HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECITON F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
A MALLEABLE DEVICE WAS IMPLANTED, DATE AND DETAILS NOT GIVEN. THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO PAIN-PROSTHESIS TOO SMALL.
BABY WAS PLACED ON ECMO ONE DAY POST OPERATION FOR HYPOPLASTIC LEFT HEART SYNDROME. PRESSURE DIFFERENCE PRE- AND POST-OXYGENATOR MEMBRANE ROSE TO 300 MMHG; LATER TO 500 MMHG. ACT'S WERE 180-220 SECONDS PER PROTOCOL. INSPECTION OF THE OXYGENATOR DID NOT REVEAL ANY SHIFTING OF THE MEMBRANE. THE BABY DID NOT IMPROVE WITH ECMO SUPPORT AND EXPIRED.
A 18 YEAR OLD FEMALE USED PRODUCT IN EAR CANAL. MOTHER ALLEGES THAT COTTON BUD CAME OFF IN EAR. SEEKING MEDICAL HELP TO REMOVE BUD.
F10: PT 2199. DEVICE 1670 1506. LABELING: LABELING CAUTIONS AGAINST USE IN THE EAR CANAL AND THAT IMPROPER USE CAN CAUSE INJURY. F12: HOME. NO SAMPLE OF THE PRODUCT WAS RETURNED FROM THE CUSTOMER. WITH THE ABSENCE OF A RETURNED SAMPLE NO FURTHER TESTING COULD BE PERFORMED. THE BATCH RECORD DID NOT INDICATE ANY TYPE OF PROBLEMS. THE MAINTENANCE LOG DID NOT INDICATE ANY TYPE OF PROBLEMS THAT WOULD AFFECT THE ANCHORAGE OF THE BUD TO THE STICK. THIS TYPE OF COMPLAINT IS MONITORED AND HAS REC'D SIGNIFICANT RESOURCE FOCUS TO REDUCE AND HOPEFULLY TO ELIMINATE THE ISSUE. THE FOLLOWING CORRECTIVE ACTIONS ARE EXAMPLES OF WHAT IS BEING DONE TO REDUCE THE COMPLAINT. A TEAM HAS BEEN WORKING TO IDENTIFY THE FAILURE MODES THAT MAY CAUSE A COTTON COMES OFF COMPLAINT ON THE TWO DIFFERENT TYPES OF MACHINES IN THE SWAB DEPT. ON THE CO'S MACHINE THE FAILURE MODE WAS THE SERRATION AREA AFTER THE SERRATING JAWS HAD OPENED. THIS HAS BEEN CORRECTED THROUGH OPERATOR AWARENESS AS WELL AS ADJUSTMENTS TO THE PNEUMATIC BRAKING SYSTEM. ON THE VERSA TYPE MACHINES VARIOUS MACHINE MODIFICATIONS HAVE BEEN PERFORMED TO PREVENT SWAB STICKS FROM PASSING THROUGH THE SERRATING AREA OF THE MACHINE WITHOUT BEING SERRATED OR WITHOUT RECEIVING A REDUCED NUMBER OF SERRATIONS. THE DIRECTION OF THE TREND INDICATES THAT THE CORRECTIVE ACTION IS HAVING A POSITIVE IMPACT.
(IAB S/N UNK) AFTER THE IAB WAS INSERTED INTO THE PT, THE DILATOR WAS REMOVED FROM THE SHEATH AND THE CLEAR HEMOSTASIS VALVE WAS UNSCREWED FROM THE SHEATH. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE VALVE WAS DISCARDED BY THE FACILITY.
A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFR. IT WAS NOT DETERMINED UNITL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96 THAT THIS WAS A 5 DAY REPORTABLE MDR. THEREFORE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILIAR COMPLAINT WILL BE REPORTED WITHIN 5 WORKING DAYS.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPICE QUIT WORKING. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
A MALLEABLE DEVICE WAS IMPLANTED, DATE AND DETAILS NOT GIVEN. THE RIGHT CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO MISPLACEMENT OF PROSTHESIS.
A RECALLED, FOUR YEAR OLD, ATRIAL, J-WIRE, BIPOLAR, RETRACTABLE SCREW PACEMAKER ELECTRODE (LEAD) OF A DIFFERENT MFR WAS BEING EXTRACTED BECAUSE THE J-WIRE HAD FRACTURED AND WAS PROTRUDING THROUGH THE OUTER INSULATION. AFTER SUCCESSFUL POSITIONING OF THE LOCKING STYLET AND ADVANCEMENT OF A TEFLON DILATOR SHEATH SET, THE DISTAL TIP OF THE ELECTRODE CAME FREE OF ITS ENDOCARDIAL ATTACHMENT. HOWEVER, THE VERY TIP APPEARED TO BE JOINED TO THE CHRONIC VENTRICULAR LEAD BY FIBRIN. THE TEFLON OUTER SHEATH WAS REPLACED WITH A POLYPROPYLENE OUTER SHEATH IN AN ATTEMPT TO FREE THE ELECTRODE TIP. BECAUSE OF THE DISTENDED CONDITION OF THE LEAD, CONSTANT TENSION ALONG THE ENTIRE LEAD BODY WAS DIFFICULT TO MAINTAIN AS THE OUTER SHEATH WAS ADVANCED. AT THIS POINT, SLIGHT PROLAPSE OF THE VEIN WAS NOTED AND THE PT'S BLOOD PRESSURE FELL. THE PT WAS IMMEDIATELY TAKEN TO AN OPERATING ROOM BUT RESUSCITATION WAS UNSUCCESFUL. AN EXAMINATION FOUND A THREE INCH TEAR IN THE INNOMINATE VEIN.
NATURE OF EVENT IS GIVEN AS A POTENTIAL COMPLICATION IN DEVICE LABELING.
DURING A CATARACT EXTRACTION PROCEUDRE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F OF THIS MEDWATCH WAS COMPLETED BY THE MFR.
OTHER DEVICE USED: CATALOG#00-5782-032-08 M/G ARTICULATING SURFACE. LOT #UNK. EVAL CODES FOR SECTION H6: 86-100-68. 86 - A DIMENSIONAL CHECK WAS PERFORMED. 100 - DEVICE HAS EXCESSIVE DAMAGE. 68 - MALALIGNMENT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.  IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE WOULDN'T PHACO PROPERLY. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUG F OF THIS MEDWATCH WAS COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.6 IS DATE OF EVENT.
A SUPERFICIAL CORNEAL BURN OCCURRED. NO INTERVENTION REPORTED.
RISK MANAGEMENT WILL NOT RELEASE PT OR DOCTOR INFO UNTIL THEY HAVE COMPLETED THEIR INVESTIGATION BY A 3RD PARTY. SERVICE CALL CANCELLED. THIS REPORT WAS MAILED IN TO FDA ON 10/3/96. THE MANUFACTURER'S INTERNAL REFERENCE NUMBER IS 9-8931-96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT CO PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED WITH A 00-5220-012-00. THE PATELLA WAS A WHITE POROUS IMPLANT.
PARTICULATE WAS SEEN IN THE EYE OF THIS PT DURING A CATARACT EXTRACTION PROCEDURE USING THIS PHACOEMULSIFICATION HANDPIECE. PARTICULATE REMAINS IN THE EYE. THE PT IS NOT EXPERIENCING ANY ADVERSE EFFECTS.
SECTIONS A THROUGH F OF THIS MEDWATCH WAS COMPLETED BY THE MFR. DATE ENTERED IN SECITON F.6. IS THE DATE OF EVENT.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT AND ANOTHER MODEL DEVICE  IMPLANTED DUE TO PT DISSATISFACTION AND PT WANTED AN INFLATABLE DEVICE.
EVALUATION CODES FOR SECTION H6: 86-100 DEVICE WAS NOT RETURNED. THEREFORE NO EVALUATION COULD BE MADE.
A 87-YR-OLD MALE WITH A HISTORY OF SICK SINUS SYNDROME TREATED WITH SINGLE 1/MIN CHAMBER PACEMAKER SUPPORT IN 1981 WITH REPLACEMENT IN 1995. AT THAT TIME HIS CHRONIC UNIPOLAR VENTRICULAR LEAD WAS RETAINED AND A LONG ADAPTER WAS USED TO ATTACH TO A PULSE GENERATOR. HIS COURSE SINCE THEN HAS SHOWN GRADUAL DETERIORATION IN UNIPOLAR IMPEDANCE, SUGGESTING INSULATION FAILURE. CLINICALLY SYMPTOMATIC OVERSENSING THREATENED THE VOO MODALITY. THE ADAPTER WAS REMOVED AND THE IMPEDANCE AND THE PACING THRESHOLD ON THE CHRONIC INDWELLING VENTRICULAR LEAD WAS SATISFACTORY, INDICATING PROBABLE INSULATION BREAK INVOLVING THE ADAPTER ONLY.
(IAB S/N UNK) THE HEMOSTASIS VALVE LEAKED EXCESSIVELY AS IF THERE WAS NO VALVE. THE IAB WAS USED WITHOUT ANY FURTHER PROBLEMS.
THE PRODUCT HAS NOT BEEN RETURNED TO CO FOR EVAL. THE PRODUCT WAS DISCARDED BY THE FACILITY. A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFR. IT WAS NOT DETERMINED UNTIL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96, THAT THIS WAS A 5 DAY REPORTABLE MDR. THEREFORE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILIAR COMPLAINTS WILL BE REPORTED WITHIN 5 WORKING DAYS.
DEVICE REMOVED DUE TO CHRONIC DISLOCATIONS.
THIS REPORT IS BEING AMENDED TO INCLUDE INFORMATION ABOUT SECTION F. SECTION F WAS NOT COMPLETED BECAUSE INFORMATION WAS PROVIDED BY ONE OR MORE CONSUMERS AND SPECIFIC DETAILS ABOUT THE USER FACILITY OR HEALTHCARE PROFESSIONAL WERE NOT AVAILABLE AT THE TIME OF THIS REPORT.
ADD'L INFO RECEIVED ON 10/10/96 INDICATES HIS MALLEABLE DEVICE WAS REMOVED DUE TO PT DISSATISFACTION.
PATELLA COMPONENT DELAMINATED, WHITE POROUS.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT DUE TO AN EXTRUSION THROUGH THE URETHRA.
THE TIBIAL INSERT WOULD NOT SNAP INTO THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
THE TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS REC'D. THE ANTERIOR LOCKING TAB EXHIBITS GROSS DISTORTION DUE TO HAVING BEEN CRUSHED DURING THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. A QUERY OF THE PRODUCT EXPERIENCE REPORT DATABASE FOUND THAT NO OTHER SIMILAR EVENT HAD BEEN REPORTED FOR THIS LOT OF INSERTS. THE EVAL RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES. IMPACTION OF A MISALIGNED INSERT DAMAGES THE ANTERIOR LOCKING TAB WHICH THEN PRECLUDES PROPER ASSEMBLY ONTO THE BASEPLATE.
DURING AN MRI PROCEDURE, A PT RECEIVING INTRAVENOUS SEDATION WAS BEING MONITORED WITH AN ECG MONITOR. FOLLOWING THE PROCEDURE, SKIN REDDENING AND 2 SKIN BURNS WERE NOTED BENEATH THE ECG ELECTRODES (RL ELECTRODE SITE HAD A THIRD DEGREE BURN, AND THE RA ELECTRODE HAD A SECOND DEGREE BURN.) THE PT'S SKIN WAS TREATED FOR BURNS. PT WAS SEMI-CONSCIOUS DURING THE PROCEDURE, AND DID NOT REPORT FEELING ANY HEATING SENSATION. ECG ELECTRODE CONTACT MAY HAVE BEEN LESS THAN OPTIMUM SINCE THE ELECTRODES DID NOT HAVE SUFFICIENT ELECTROLYTE EVIDENT UPON REMOVAL FROM THE PT.
THE DEVICE WAS EVALUATED BY THE HOSP BIOMEDICAL ENGINEERING STAFF, AND THE REPORTED DEVICE FUNCTIONED WITHOUT PROBLEM. DUE TO THE NATURE OF THIS REPORT, ECG ELECTRODE HEATING IS ATTRIBUTABLE TO THE USE AND/OR PREPARATION OF THE ECG ELECTRODES, THE TECHNIQUES USED IN POSITIONING THE ECG LEADS/CABLES, AND THE TYPE OF MRI SCANS PERFORMED DURING MONITORING OF THE PT. HENCE, NO FURTHER INSPECTION OF THE DEVICE WAS DEEMED NECESSARY. THE MOST PROBABLE CAUSE OF THIS EVENT WAS THE POSSIBLE USE OF POORLY GELLED ELECTRODES, OR POSSIBLY THE USE OF AN ELECTRODE WITHOUT THE GEL PAD AND ELECTROLYTE IN PLACE. IF ANY RF CURRENT FROM THE MRI SYSTEM FLOWED WITHIN THE ECG CABLE AND ELECTRODES, THIS CURRENT WOULD BE "CONCENTRATED" OVER SMALLER SURFACE AREAS, AND INCREASE THE CURRENT DENSITY AT THE SKIN/ELECTRODE INTERFACE. A SUFFICIENT INCREASE IN CURRENT DENSITY AT THE SKIN CAN LEAD TO SKIN HEATING, AND SUBSEQUENT SKIN BURNS. THE PROBABLE SMALL CONTACT SURFACE AREA OF THE ELECTRODES THE POSSIBLE FORMATION OF A LOOP BETWEEN THE PT'S BODY AND ECG CABLE LOOP, THE TYPE OF MRI SCAN PERFORMED (THORACIC AND LUMBAR SPINE SCANS, WHICH TYPICALLY REQUIRE HIGHER SAR LEVELS,) AND POSSIBLE PLACEMENT OF THE ECG PT CABLE POSSIBLY ALL CONTRIBUTED TO THE EVENT OCCURRENCE. IF ANY PORTION OF THE PT'S BODY WAS IN CONTACT WITH THE MRI MAGNET BORE WALL DURING ANY OF THE SCANS, THIS BODY PART (E.G. ARM, LEG, ELBOW, ETC.) COULD PARTIALLY FORM A LOOP WHICH COULD INDUCE RF CURRENT TO FLOW AND POSSIBLE COUPLE WITH THE CURRENT FLOWING IN THE PT ECG CABLE. ALTHOUGH IT COULD NO BE DETERMINED IF THIS CONDITION OCCURRED, FROM THE DESCRIPTION OF THE ELEVATED POSITION OF HER KNEES, IT IS CONSIDERED POSSIBLE THAT A BODY PART COULD HAVE CONTACTED THE MRI BORE, AND MAY HAVE CONTRIBUTED TO THE ELECTRODE HEATING. CONTACT OF THE PT'S SKIN OR BODY PARTS IS CONTRAINDICATED IN THE MRI MFR'S PRODUCT LABELING. DURING DEEP BODY (THORACIC AND LUMBAR SPINE) SCANS, HIGHER SPECIFIC ABSORPTION RATIO (SAR) LEVELS WOULD HAVE BEEN NEEDED. THE TRANSMIT-GAIN VALUES FOR THIS PT WERE REPORTED, AND FROM THIS INFO, IT APPEARS THAT THE TRNSMIT-GAIN LEVELS WERE NOT AT THE MAXIMUM LEVELS, AND THE PROBABILITY OF ANOTHER CAUSE OF INCREASED RF CURRENT FLOWING IN THE ECG CABLE(E.G. A LOOP IN THE PT CABLE, OR POSSIBLE CONTACT OF THE PT'S SKIN WITH THE MRI BORE) IS MORE LIKELY. THE MRI TECHNOLOGISTS DID NOT BELIEVE A LOOP EXISTED IN THE PT CABLE, BUT THEY WERE NOT CERTAIN OF ITS POSITION WITHIN THE MRI BORE. THE OPERATOR'S MANUAL AND OPERATOR'S USER PRECAUTION CARD FOR THIS MONITOR INSTRUCT THE OPERATOR THAT SAR LEVELS ABOVE 0.4 WATT/KG (AVERAGE) GREATLY INCREASES THE RISK OF PTS BURNS, AND THAT HIGHER TGS, AND THE USE OF BODY COIL TRANSMIT/SURFACE COIL RECEIVE TYPE SCANS SHOULD ALERT THE OPERATOR TO BE ESPECIALLY CAUTIOUS ABOUT POTENTIAL ELECTRODE HEATING. THE USE OF HIGH QUALITY ECG ELECTRODES IS RECOMMENDED, AND MAKING SURE THE ELECTRODES ARE NOT DRY IS EMPHASIZED. (*)
INSUFFICIENT INFO TO DETERMINE PRECISE CAUSE OF REPORTED PROBLEM. POSSIBLE CAUSES ARE: SCRAPING OF THE ANTERIOR WALL OF THE VAGINA DURING REMOVAL OF THE INSTRUMENTS (INNER SHEATH WAS RETURNED WITH A CHIPPED DISTAL EDGE EXPOSING SHARP SUBSTRATE); OR ALLERGIC RESPONSE TO THE SURGILUBE LUBRICANT OR ONE OF ITS COMPONENTS.
EVALUATION CODES FOR SECTION H6: 86-100 DEVICE WAS NOT RETURNED. THEREFORE  NO EVALUATION COULD BE MADE.
OTHER DEVICES USED: CATALOG #00-6528-00 ACETABULAR CUP. LOT #58718700. CATALOG #00-9026-030-00 CO'S FEMORAL HEAD LOT #50171500. CATALOG #UNKNOWN (4) BONE SCREWS LOT #UNKNOWN. EVALUATION CODES FOR SECTION H6: 86-100 86-A DIMESIONAL CHECK WAS PERFORMED. 100-MATERIALS RESEARCH LAB CONFIRMED. DAMAGE TO DEVICES PROBABLY OCCURRED DURING REMOVAL. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "Y", IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NA. IF "N", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? NO. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "Y", IS SVENT OF GREATER SEVERITY THAN STATED IN LABLEING? NA. IF "N", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY EITHER UNKNWON OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
(IAB S/N UNK) THE CLEAR HEMOSTASIS VALVE LEAKED DURING INSERTION. THE WAS ACCIDENTLY UNSCREWED. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE VALVE WAS DISCARDED BY THE FACILITY.
A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFR. IT WAS NOT DETERMINED UNTIL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96 THAT THIS WAS A 5 DAY REPORTABLE MDR. THEREFORE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILIAR COMPLAINTS WILL BE REPORTED WITHIN 5 WORKING DAYS.
PAIR OF SCISSORS BROKE OFF AT THE JOINT DURING A RHINOPLASTY PROCEDURE. ANOTHER PAIR OF SCISSORS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTON F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. CORROSION AND NICKS WERE FOUND ON THE BLADE. THIS PAIR OF SCISSORS APPEARS TO HAVE BEEN ABUSED.
RESULTS: 100CC SLIGHT AMBER COLOR, 100E FOREIGN MATERIAL, 100F VOIDS IN GEL CONCLUSIONS: FOREIGN MATERIAL OF UNDETERMINED SOURCE AND COMPOSITION. COLOR WITHIN SPECIFICATION LIMITS. VOIDS CAUSED BY REPEATED STERILIZATIONS.
REPORTER ALLEGES PATIENT RECEIVED IMPLATNS ON AN UNK DATE. REPORTER ALSO ALLEGES PATIENT HAD REMOVAL ON SEPT. 3, 1996 DUE TO "MECHANICALLY DEFECTIVE" IMPLANTS; HOWEVER, NO SPECIFICS WERE GIVEN. REF. MEDWATCH #1010991.
REPORTER ALLEGES PATIENT RECEIVED IMPLANTS ON AN UNK DATE. REPORTER ALSO ALLEGES PATIETN HAD REMOVAL ON SEPT. 3, 1996 DUE TO "MECHANICALLY DEFECTIVE" IMPLANTS; HOWEVER, NO SPECIFICS WERE GIVEN. REF. MEDWATCH #1009991.
THE THREADS BROKE OFF IN THE IMPLANT DURING THE SURGICAL PROCEDURE. THE REPORTER ALSO STATES, THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVAL: THE EVENT IS ATTRIBUTED TO USER NOT FULLY THREADING INNER ROD TO THE IMPLANT, RESULTING IN FRACTURE AT AREA OF MAXIMUM STRESS (EXPOSED THREAD). ADD'L INFO HAS BEEN REQUESTED FROM THE INITIAL REPORTER. IF FURTHER INFO BECOMES AVAILABLE THE REPORT WILL BE UPDATED.
CONCLUSION: 68A OTHER (NO DEVICE RETURNED.)
CONCLUSION: 68A OTHER (NO DEVICE RETURNED)
PATIENT ALLEGES RECEIVING IMPLANTS ON JUNE 29, 1973. PATIENT ALSO ALLEGES SHE SUFFERS FROM FIBROCYSTIC DISEASE, DUCTAL HYPERPLASIA, CHEST PAIN AND INTERNAL ADHESIONS CAUSED FROM HER IMPLANTS. PATIENT ALSO ALLEGES SHE HAD HER IMPLANTS REMOVED ON OCT. 27, 1994 DUE TO RUPTURE. EVALUATION OF DEVICES BY DR. INDICATES BILATERAL RUPTURED DEVICES.
PATIENT ALLEGES RECEIVING IMPLANTS ON JUNE 29, 1973. PATIENT ALSO ALLEGES SHE SUFFERS FROM FIBROCYSTIC DISEASE, DUCTAL HYPERPLASIA, CHEST PAIN AND INTERNAL ADHSIONS CAUSED FROM HER IMPLANTS. PATIENT ALSO ALLEGES SHE HAD HER IMPLANTS REMOVED ON OCT. 27, 1994 DUE TO RUPTURE. EVALUATION OF DEVICES BY DR. INDICATES BILATERAL RUPTURED DEVICES.
(IAB S/N UNK) THE CLEAR HEMOSTASIS VALVE LEAKED RIGHT AWAY. AFTER THE IAB WAS ATTACHED, THE LEAK STOPPED. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE VALVE WAS DISCARDED BY THE FACILITY.
PT ALLEGES RECEIVING AN IMPLANT ON AN UNKNOWN DATE. SHE STATES, "HAVING IMPLANT THAT IS RUPTURED." THE LOT NUMBER CANNOT BE VERIFIED WITH THE CATALOG NUMBER.
LOT NUMBER IS NOT CONSISTENT WITH CO CATALOG NUMBER.
BUTTONS FUNCTIONED INTERMITTENTLY AND THEN CEASED FUNCTIONING IN THE MIDDLE OF THE CASE. NO PT INJURY.
DEVICE NOT RETURNED, LOT # NOT KNOWN. NO FURTHER INVESTIGATION CAN BE DONE AT THIS TIME. HOSP HAS INDICATED THAT THEY WILL NOT FILE A MEDWATCH REPORT AS THERE WAS NO MEDICAL TREATMENT REQUIRED.
(IAB S/N UNK) THE DR TRIED TO INSERT A BALLOON WITH A 10 FR DILATOR INTO THE SHEATH AND HAD ALOT OF RESISTANCE. THE DR WET THE DILATOR AND WAS ABLE TO GET IT IN. WHEN THE DILATOR WAS TAKEN OUT, ALOT OF BLEEDING WAS NOTED FROM THE HEMOSTASIS VALVE.
TO DATE THE PRODUCT HAS NOT BEEN RETURNED TO CO FOR EVAL. A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFR. IT WAS NOT DETERMINED UNTIL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96, THAT THIS WAS A 5 DAY REPORTABLE MDR. THEREFORE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILIAR COMPLAINTS WILL BE REPORTED WITHIN 5 WORKING DAYS.
A SCREW COMPONENT OF THE SPINAL FIXATOR CONSTRUCT BROKE. AN AUTOIMMUNE REACTION TO THE METAL ALLOY USED FOR THIS DEVICE WAS SUSPECTED TO HAVE OCCURRED. NO OTHER INFO WAS PROVIDED.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSIONN THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES.
FEMORAL NAIL FRACTURED. DEVICE WAS REMOVED AND REPLACED.
EVALUATION CODES FOR SECTION H6: 86-100-200-68. 86-A DIMENSIONAL CHECK WAS PERFORMED 100- THE NAIL WAS TESTED IN THE LAB AND IS 316L STAINLESS STEEL AS SPECIFIED. 200-VISUAL EXAM IN THE RESEARCH LAB INDICATES SEVERE WEAR OR BURNISHING ON THE FRACTURE SURFACE 68-THE SCANNING ELECTRON MICROSCOPE INDICATES THE FATIGUE STRIATIONS OBSERVED ON THE FRACTURE SURFACE INDICATE THAT THIS FRACTURE OCCURRED BY FATIQUE. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "Y", IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NA. IF "N", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "Y", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? NA. IF "N", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNWON OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE PHYSICIAN PLACED A COATED ESOPHAGEAL STENT IN THE PT. THE NEXT DAY THE PT EXPERIENCED CHEST PAIN. AN ENDOSCOPY WAS PERFORMED AND IT WAS NOTED THE STENT WAS MAKING CONTACT WITH THE HIATAL HERNIA SACK CAUSING A HEMATONA. AN ATTEMPT TO REMOVE THE STENT WITH A SNARE WAS MADE; HOWEVER, IT WAS UNSUCCESSFUL. THE PT WAS TAKEN TO SURGERY WHERE THE STENT WAS REMOVED. NO FURTHER COMPLICATIONS OCCURRED AND THE PT IS IN SATISFACTORY CONDITION.
THIS REPORT IS BASED ENTIRELY ON UNCONFIRMED INFO SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENTED TO BE AN ADMISSION THAT ANY WILSON COOK DEVICE (I) IS DEFECTIVE OR MALFUNCTIONED OR (II) CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. CO DOES NOT BELIEVE THAT THIS REPORTED INCIDENT IS LILELY TO REOCCUR.
SURGEON DISCOVERED PITTING OF THE POLYETHYLENE DURING KNEE ARTHROSCOPY.
THE BROACH WAS FOUND TO BE BROKEN AFTER THE SURGICAL PROCEDURE. THE X-RAY SHOWED THE BROKEN END TO BE IN THE PT. THE ORIGINAL SURGERY DATE IS UNKNOWN AT THIS TIME. THE REPORTER STATES THIS EVENT DID NOT RESULT IN AN ADVERSE CONSEQUENCE FOR THE PT. THE CATALOG NUMBER AND DATE INFO IS UNCONFIRMED AT THIS TIME. ADD'L INFO HAS BEEN REQUESTED.
SUMMARY OF EVALUATION: EVALUATION OF THE DEVICE FOUND THE SPRING WAS NOT CORRECTLY ADJUSTED, SUGGESTING USER DISASSEMBLY. WELDING OF SCREWS AND A LOCKING MECHANISM IMPROVEMENT HAVE BEEN INITIATED TO PREVENT RECURRENCE.
AFTER ONE HR INTO OPEN-HEART SURGERY PROCEDURE, PERFUSIONIST NOTICED LARGE BOLUS OF AIR FROM VENOUS RESERVOIR TO PUMP HEAD. TUBING WAS CLAMPED OFF-AIR ELIMINATED BUT PUMP FAILED TO START. REPLACED WITH SECOND PUMP.
THE POLYETHYLENE INSERT COMPONENT OF THE ACETABULUM PROSTHESIS BROKE. THE COMPONENT WAS BELIEVED TO BE IMPLANTED IN 1989. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. D.6. - EXACT SIZE OF THE IMPLANT IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO.
THE DEVICE WAS APPLIED A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE OBTURATOR SLEEVE DISENGAGED INTO THE PT. THE HSP HAS REPORTED THE COMPONENT WAS RETRIEVED LAPAROSCOPICALLY WITHOUT INCIDENT.
F 10) PT CODE: 2477 "OXYGEN SATURATION LOW" DUE TO NO BLOOD FLOW IS NOT ADDRESSED IN THE LABELING. DEVICE CODE: 1502 "FAILURE TO PUMP" IS NOT ADDRESSED IN THE LABELING. H1) ALTHOUGH THE MEDWATCH REPORT FROM THE USER INDICATES A PRODUCT PROBLEM AND NOT AN ADVERSE EVENT, A PHONE CALL WITH THE RISK MANAGER REVEALED THAT THE PT SUFFERED A SHORT TERM MEMORY DEFICIT; HENCE, CO IS CLASSIFYING THIS EVENT AS A SERIOUS INJURY. H3) THE DEVICE WAS RETURNED TO CO, BUT UPON ITS RETURN, THE USER CALLED AND REQUESTED THE DEVICE BACK. IT WAS RETURNED TO THE USER UNOPENED. H6) THE REPORTED INJURY WAS THE RESULT OF INSUFFICIENT BLOOD FLOW BECAUSE THE CENTRIFUGAL PUMP SPEED CONTROL MODULE (NOT MANUFACTURED BY CO) FAILED TO RUN. THE REPORTED INJURY WAS NOT THE RESULT OF A MALFUNCTION OF THE OXYGENATOR. THIS REPORT IS BEING FILED BECAUSE A MEDWATCH REPORT WAS RECEIVED FROM THE USER FACILITY AND A PT INJURY WAS IMPLIED.
THE INFUSION PUMP WAS INVOLVED IN AN OVERDELIVERY. A 250 ML BAG HEPARIN WAS PROGRAMMED TO INFUSE AT 15 ML/HR. SIXTY TO NINETY MINUTES LATER THE SOLUTION BAG WAS EMPTY. THE PUMP STILL DISPLAYED A VOLUME TO BE INFUSED OF 180 ML. THE PT'S PTT LEVEL WAS ELEVATED, WHICH DELAYED HIS SCHEDULED CARDIAC SURGERY. HOWEVER NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.
SECTION F COMPLETED BY THE MFR. EVALUATION SUMMARY FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION.
IT WAS REPORTED THE EZ35B WAS USED DURING AN LAVH. THE EZ35 WAS DIFFICULT TO REOPEN AFTER FIRING. THE SURGEON WAS ABLE TO REOPEN BY PULLING THE HANDLE OPEN. ANOTHER EZ35 WAS OPENED TO COMPLETE THE CASE. NO BUTTRESSING MATERIAL WAS USED. THERE WAS NO CONSEQUENCE TO THE PT.
PT HAS BEEN PARAPLEGIC DUE TO MVA. FRACTURED HIP; TO OR FOR OPEN REDUCTION, INTERNAL FIXATION WITH IM ROD. HAS MULTIPLE DECUBITI AND CHRONIC ULCERS. WAS IN HOSP APPROX 1 MONTH AGO FOR INCISION AND DRAINAGE OF ULCER AT OLD SURGERY SITE. TREATED AND SENT HOME ON IV ANTIBIOTICS. RE-ADMITTED WITH CONTINUED INFECTION. ORTHO CONSULT FELT IM ROD MIGHT BE INFECTED. TO OR FOR REMOVAL OF ROD.
DEVICE THROMBOSIS LIKELY SECONDARY TO DISCONNECT OF THE PNEUMATIC DRIVE LINE.
PT DEVELOPED SYMPTOMS OF AIR LEAK IN SYSTEM. PT WAS TAKEN TO OR AND RE-IMPLANTED WITH A SIMILAR DEVICE.
DURING PREVENTATIVE MAINTENANCE TEST THE DEVICE DID NOT INFUSE THE SET AMOUNT. NO FURTHER INFO AVAILABLE.
THIS M.D.R IS BEING FILED IN ORDER TO COMPLY WITH 21 CFR PART 803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT THE DEVICE ACTUALLY MALFUNCTIONED OR CAUSED ANY INJURY. H3: THE ABOVE CODES ADEQUATELY DESCRIBE THE METHODS, RESULTS AND CONCLUSION. H6: 200- DEVICE APPEARS TO HAVE BEEN DROPPED.
(IAB S/N UNK) THE HEMOSTASIS VALVE ON THE SHEATH WAS TAKEN APART, AND THERE WAS MASSIVE BLEEDING. THE IAB WAS REMOVED AND A 2ND WAS INSERTED. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE VALVE AS DISCARDED BY THE FACILITY.
A SAFETY ALERT WS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFRE. IT WAS NOT DETERMINED UNTIL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96, THAT THIS WAS A 5 DAY REPORTABLE MDR. THEREFOREE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILAR COMPLAINTS WILL BE REPORTED WITHIN 5 WORKING DAYS.
SECTIONS A THROUGH F WERE COMPLETED BY MFR. DATE ENTERED IN SECTION F.13 IS DATE DESCRIPTION OF FAILURE WAS RECEIVED. ADDITIONALLY, THERE WAS A DEFORMITY AT TAIL OF HANDPIECE, ASPIRATION TUBE WAS MISALIGNED AND IRRIGATION TUBE WAS TWISTED.
THIS PHACOEMULSIFICATION HANDPIECE EXHIBITED INTERMITTENT POWER THAN FAILED COMPLETELY DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER SYSTEM WAS USED TO SUCCESSFULLY COMPLETE PROCEDURE.
(IAB S/N UNK) WHEN THE IAB WAS INSERTED, THERE WAS ALOT OF BLEEDING FROM THE HEMOSTASIS VALVE. THE DR FELT THAT THE VALVE WAS NOT CONNECTED PROPERLY. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE VALVE WAS DISCARDED BY THE FACILITY.
A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFR. IT WAS NOT DETERMINED UNTIL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96, THAT THIS WAS A 5 DAY REPORTABLE MDR. THERFORE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILIAR COMPLIANTS WILL BE REORTED WITHIN 5 WORKING DAYS.
ALARMS ON BEDSIDE FOUND OFF AND PT HAD OXYGEN SATURATION OF 40%.
HOSP HAS REFUSED CO ACCESS TO EQUIPMENT AND INFO RELATING TO REPORTED EVENT FOR PURPOSE OF CONDUCTING AN EVALUATION.
DR WENT TO HAVE PT BITE DOWN ON THE NEW CROWN AND THE ABUTMENT BROKE AT THE WELD JOINT. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE MD.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DR'S OFFICE.
METHOD (86): PART NOT RETURNED. L/N NOT AVAILABLE FROM DR'S OFFICE.
A PT PRESENTED WITH LOOSE IMPLANT, IMPLANT WAS REMOVED. PT WAS NOT SEEN SINCE 10/92. FOLLOW-UP REMINDERS WERE SENT PT DID NOT RESPOND. IN 1994PT SAID FOLLOW-UP WAS BEING HANDLED BY GP WOULD NOT BE COMING BACK TO DR ANYMORE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO WAS UNABLE TO REVIEW THE PRODUCT'S LOT HISTORY SINCE THE LOT NUMBER WAS UNAVAILABLE FRO MTHE DOCTOR'S OFFICE.
THE ACETABULAR INSERT WOULD NOT LOCK INTO THE SHELL. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
H4: MFG. DATE = 11/13/95. SECTION F: SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AS RECEIVED THE ACETABULAR INSERT IS OBSERVED TO BE IN EXCELLENT CONDITION. DUE TO SUBSEQUENT MFG OPERATIONS, THE RELEVANT INSERT DIMENSIONS CANNOT BE ASCERTAINED. THE RETURNED INSERT WAS FUNCTIONALLY TESTED WITH TWO ACCEPTABLE VITALOCK OUTER SHELLS. THIS TEST REVEALED THE RETURNED INSERT SEATED AND LOCKED TIGHTLY IN BOTH OUTER SHELLS. THE RETURNED INSERT FUNCTIONS AS INTENDED BY DESIGN. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO DISCREPANCIES. THE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS NOT ASSOCIATED WITH THE DEVICE.
THERE WAS SOME MOVEMENT OF THE INSERT INSIDE THE BIPOLAR SHELL. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
DUE TO TOLERANCES REQUIRED TO MANUFACTURE THE BIPOLAR ASSEMBLY, SOME TOGGLE MAY BE PRESENT BETWEEN THE INSERT AND METAL SHELL. THIS TOGGLE IS IN COMPLIANCE WITH THE TOLERANCE REQUIREMENTS FOR THIS PRODUCT AND IS FUNCTIONALLY ACCEPTABLE.
THE TIBIAL INSERT WOULD NOT SNAP INTO THE BASEPLATE. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVAL: THE TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE INSERT IN THE AS-RECEIVED CONDITION WAS ASSEMBLED ONTO THREE BASEPLATES WITH THE RESULTS OF CRISP SNAP ACTION AND FULL, TIGHT SEATING. IMPACTION WAS NOT REQUIRED TO OBTAIN SEATING. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE EXAM RESULTS, ALTHOUGH INCONCLUSIVE IN THE ABSENCE OF THE EVENT BASEPLATE, SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED.
THE PRODUCT, A URETERAL STENT, WAS INSERTED DURING SURGERY TO ALLOW KIDNEY DRAINAGE FOLLOWING ANASTOMOSIS OF THE RIGHT URETER. SOME TIME AFTER INSERTION THE STENT DEVELOPED FRACTURES. THE PT RETURNED TO SURGERY, AS PLANNED, FOR REMOVAL OF TWO STENTS. THE LEFT STENT WAS REMOVED BUT THE SURGEON WAS UNSUCCESSFUL IN REMOVING THE FRACTURED STENT. HE BROUGHT THE PT BACK TO SURGERY LATER AND REMOVED THE FRACTURED STENT. THERE WAS NO DAMAGE TO THE URETER.
REPORT REC'D OF INTER ELECTRODE REGION KINKED WITH WIRE FRACTURE NOT SUSPECTED.
A COMPLETE INVESTIGATION CANNOT BE MADE SINCE THE PRODUCT WILL NOT BE RELEASED FOR EVAL. THE LOT NUMBER OF THE STENT LISTED IN THIS REPORT EXPIRED IN 1988.
DURING AN OOPHOROCYSTECTOMY PROCEDURE, THE SAFETY SHIELD DID NOT RETRACT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/30/96 MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT. DUE TO A CLERICAL ERROR, THE STATUTORY MDR FILING DATE WAS MISSED.
REPORT REC'D OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
THIS ENTIRE FORM COMPLETED BY MANUFACTURER. UNABLE TO PERFORM ANALYSIS LEAD DAMAGED.
THE REPORTER, A 65 YR OLD DIALYSIS PT DIAGNOSED WITH TYPE II DIABETES 20 YRS AGO WENT TO ER TWICE IN THE LAST WEEK FOR LOW BLOOD SUGAR (LEVEL UNKNOWN). THE PT REPORTS THAT SHE LOST CONSCIOUSNESS. THE PT WAS GIVEN CANDY AND JUICE AT THE ER. PRIOR TO ONE OF THESE VISITS TO THE ER, THE PT OBTAINED A RESULT OF 180-200 WITH THE SUSPECT DEVICE AND TOOK HER USUAL GLYBURIDE MEDICATION FOR THAT READING. THE PT STATES THAT THE DIALYSIS CENTER METER AND THE PHYSICIAN'S METER READ 100 MG/DL LOWER THAN THE SUSPECT DEVICE.
CUSTOMER ALLEGES AN INJURY WHEN A PLUG EJECTED FROM HIS GUN AND BROKE THE LENS OF HIS SUNGLASS.
ACTUAL MANUFACTURING SITE COULD NOT BE DETERMINED.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SAFETY SHIELD DID NOT RETRACT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
UNKNOWN PHYSICIAN REPORTED TO A COMPANY EMPLOYEE THAT THE PT HAD VENTRICULAR TRACHYCARDIA AT TIME OF DEATH. IT WAS ALSO REPORTED THAT THE DEVICE HAD NO OUTPUT.
NO USER FACILITY REPORT RECEIVED, SECTIONS OF BLOCK F HAVE BEEN COMPLETED BY THE MFR. INVESTIGATION IS ONGOING. DISCLAIMER ADDED. DISCLAIMER: THE SUBMISSION OF INFO BY TELECTRONICS PACING SYSTEMS PURSUANT TO MEDICAL DEVICE REPORTING (MDR) REGULATIONS DOES NOT CONSTITUTE AN ADMISSION THAT TELECTRONICS PACING SYSTEMS BELIEVES THAT THE DEVICE DESCRIBED ABOVE HAS MALFUNCTIONED OR THAT THERE EXIST ANY CASUAL CONNECTION BETWEEN THE DEVICE AND A DEATH OR SERIOUS INJURY. ANY FREQUENCY DETERMINATION MADE BY TELECTRONICS PACING SYSTEMS FOR MDR SUBMISSION WILL BE MADE ON AN INTRA-MODEL BASIS AND DOES NOT REFLECT ANY FUTURE FREQUENCY ANALYSIS MADE ON AN INTER-MODEL COMPONENT LEVEL.
THE LEAD WAS PREVIOUSLY REPORTED AS J RETENTION WIRE FRACTURE. THE LEAD HAS BEEN EXPLANTED DUE TO A REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
PT ADMITTED FOR UNDESIRED FERTILITY, UNDERWENT LAPAROSCOPIC RIGHT TUBAL FULGURATION AND LYSIS OF ADHESIONS. INCIDENTAL CAUTERY BURN TO SMALL BOWEL OCCURRED. EXPLORATORY LAPAROTOMY WAS DONE TO REPAIR SMALL BOWEL THERMAL BURN ENTEROTOMY. THE EXPLORATORY LAPAROTOMY AND BOWEL REPAIR WAS NECESSARY BECAUSE THE SURGEONS INCIDENTLY BURNED PART OF THE PT'S BOWEL WHILE CAUTERIZING AN ABDOMINAL ADHESION. ELECTROSURGERY SETTING WAS AT 35.35 A 4.0 CM X 2.5 CM SEGMENT OF SMALL BOWEL WAS REMOVED AND ENDS OF BOWEL ANASTOMOSED. ON 5/23/96 PT STILL DOING WELL WITH NO PROBLEMS.
REPORT REC'D OF INTER ELECTRODE REGION KINKED WITH WIRE FRACTURE SUSPECTED BUT NOT VISULIZED BY FLUOROSCOPY.
A PT COMPLAINED OF CHILLS AND INDIGESTION DURING THE LAST HOUR OF A FOUR HOUR TREATMENT AND WAS DIAGNOSED AS HAVING HEMOLYSIS.
THE UNUSED SAMPLE FROM THE SAME LOT NUMBER WAS RETURNED. THE UNITS WAS TESTED FOR PYROGEN, ACUTE SYSTEMIC TOXICITY, INTRACUTANEOUS TOXICITY AND HEMOLYSIS; NO ABNORMALITY WAS OBSERVED. THE RESIDUAL ETHYLENE OXIDE LEVEL WAS TESTED AND IT WAS BELOW THE ACCEPTANCE LIMIT. THE ROUTINE MFG QUALITY ASSURANCE TEST RESULTS FOR STERILITY, BIOLOGICAL TESTS AND EXTRACTION TESTS WERE REVIEWED AND ALL WERE WITHIN SPECIFICATION. NO CAUSE FOR THIS INCIDENT COULD BE IDENTIFIED.
DURING AN UNSPECIFIED PROCEDURE, REPORTEDLY. THE STAPLE LINE WAS INCOMPLETE. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE.
DURING BANDING OF LEFT FALLOPIAN TUBE, TUBE WAS TRANSECTED. BLEEDING WAS VISUALIZED ON THE MONITOR VIA CAMERA. MINI-LAPAROTOMY DONE AND LEFT FALLOPIAN TUBE REPAIRED. ESTIMATED BLOOD LOSS WAS 200CC.
THE LEAD WAS RECEIVED SNIPPED OR CUT INTO AN APPROX. 40CM DISTAL PORTION WITH NO ELECTRODE TIP RECEIVED. X-RAY OF THE LEAD INDICATED THAT ONLY APPROX. 101MM OF THE "J" STIFFENER WIRE WAS RECEIVED. IT APPEARS THAT THE "J" STIFFENER WIRE FRACTURED APPROX. 17MM PROXIMAL OF THE ELECTRODE TIP WITH ALL RECORDED MEASUREMENTS OF THE "J" STIFFENER ADDING UP TO APPROX. 101MM.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
THE PT WAS ADMITTED FOR UNDESIRED FERTILITY, UNDERWENT LAPAROSCOPIC RIGHT TUBAL FULGURATION AND LYSIS OF ADHESIONS. INCIDENTAL CAUTERY BURN TO SMALL BOWEL OCCURRED. EXPLORATORY LAPAROTOMY WAS DONE TO REPAIR SMALL BOWEL THERMAL BURN ENTEROTOMY. THE EXPLORATORY LAPAROTOMY AND BOWEL REPAIR WAS NECESSARY BECAUSE THE SURGEONS INCIDENTLY BURNED PART OF THE PT'S BOWEL WHILE CAUTERIZING AN ABDOMINAL ADHESION. ELECTROSURGERY SETTING WAS AT 35.35 A 4.0 CM X 2.5 CM SEGMENT OF SMALL BOWEL WAS REMOVED AND ENDS OF BOWEL ANASTOMOSED. ON 5/23/96 PT STILL DOING WELL WITH NO PROBLEMS.
THE CUSTOMER WAS CONTACTED AND THE GENERATOR WILL NOT BE RETURNED TO CO FOR EVALUATION. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OR VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
THE PT WAS IN KIDNEY FAILURE AND HAD TRIPLE LUMEN CATHETER INSERTED WITH NO PROBLEM. TWO DAYS LATER THE PT REQUIRED DIALYSIS AND ANOTHER MFR'S CATHETER WAS INSERTED. AN X-RAY WAS TAKEN TO VERIFY CATHETER PLACEMENT AND REVEALED THE PRESENCE OF A GUIDE WIRE WHICH HAD MIGRATED INTO THE SUPERIOR VENA CAVA. UPON CHECKING ALL GUIDE WIRES FROM THE OTHER MFR, THEY SURMISED IT WAS THE GUIDE WIRE THAT WAS IN THE PT. THE WIRE WAS REMOVED WITHOUT ANY COMPLICATION.
MFR CONTROL NO. DC96-580 PRODUCT LABELING CAUTIONS THE USER TO MAINTAIN A FIRM GRIP ON THE SPRING WIRE GUIDE AT ALL TIMES.
DURING A BLADDER SUSPENSION, THE INSTRUMENT DID NOT FIRE PROPERLY. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/30/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUMITTED INITIAL REPORT.
AORTOGRAM AND LOWER EXTREMITY ARTERIOGRAM PERFORMED VIA LEFT AXILLARY ARTERY. ATTEMPTED BALLOON DILATION IMMEDIATELY FOLLOWED VIA LEFT AXILLARY ARTERY, BUT BALLOON CATHETER BROKE IN THE INFRARENAL AORTA. PT IS QUESTIONABLE SURGICAL CANDIDATE, HAD EARLIER DECLINED SURGERY FOR BYPASS GRAFT. THEREFORE, THE DISTAL CATHETER FRAGMENT, ABOUT 10 CM LONG, REMAINS IN HER DISTAL AORTA. POSSIBLE FUTURE OCCLUSION OF AORTIC BIFURCATION WITH BYPASS GRAFT FOLLOWING UNSUCCESSFUL ATTEMPT TO ANGIOPLASTY.
THE REPORT STATES THAT ON 9/17/96, THE PT HAD BEEN SCHEDULED FOR REMOVAL OF ANOTHER MFR'S DEVICE TO BE REPLACED WITH THE MFR'S DEVICE. THE PT HAS HAD SEVERAL VENOUS ACCESS DEVICES WHICH ALL HAVE HAD COMPLICATIONS AND INFECTIONS. THE SURGEON WAS ABLE TO ASPIRATE AND FLUSH THE OTHER MFR'S DEVICE CATHETER, THEREFORE, THE SURGEON LEFT THE DEVICE CATHETER IN PLACE AND RE-ATTACHED IT TO THE MFR'S DEVICE. THE PT WAS BROUGHT TO THE ONCOLOGIST OFFICE FOR CHEMOTHERAPY; HOWEVER, THE DEVICE COULD NOT BE ASPIRATED. A DYE STUDY WAS PERFORMED AND REVEALED A BLOCKED CATHETER AND FIBRIN SHEATH. ON 9/26/96, THE MFR DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MFR'S DEVICE.
OM 10/1/96, THE MFR'S SALES REP REPORTED ADD'L INFO CONCERNING THIS EVENT. THE MFR'S DEVICE WAS REPLACED WITH ANOTHER MFR'S DEVICE. THE EXPLANTED DEVICE WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS. THE MFR'S SALES REP DOES NOT BELIEVE THIS EVENT WAS RELATED TO THE MFR'S DEVICE. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENT INVOLVING THIS CATALOG NUMBER AND DID NOT REVEAL ANY TRENDS. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MANUFACTURING VARIANCES IN RELATION TO THIS EVENT. BASED ON THE INFO AVAILABLE, IT APPEARS THAT THIS EVENT WAS NOT RELATED TO THE MFR'S DEVICE, BUT DUE TO THE BLOCKED CATHETER AND FIBRIN SHEATH. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING THE FILE ON THIS EVENT.
BILATERAL RUPTURE OF SILICONE BREAST IMPLANTS WITH CALCIFICATION. REQUIRING SURGICAL REMOVAL.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT REMOVAL. THE PT UNDERWENT AN UNSCHEDULED TREATMENT THE NEXT DAY. THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE WAS FOUND TO HAVE FAILED.
A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 9/18/96. THE RETURNED THERMAL FUSE WAS CONNECTED AT AN OHM METER. THE METER SHOWED 269.5 OHMS, INDICATING THAT THE FUSE WAS BAD. THE READING ON A GOOD FUSE IS BELOW 1 OHM. THE THERMAL FUSE WAS DISASSEMLBED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNATED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. SAFETY ANALYSIS: TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE CENTRYSYSTEM 3 OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PATIENT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION( P. 3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN  THE ULTRAFILTRATION RATE. FOLLOW UP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT.
ON 9/23/96, THE MFR RECEIVED A MEDICAL DEVICE TRACKING REPORT WHICH STATES THAT THE DEVICE WAS REMOVED ON 8/29/96 DUE TO INFECTION.
FURTHER COMMUNICATION WITH THE FACILITY O.R. NURSE, ON 9/27/96, REVEALED THAT THE INFECTION WAS NOT BELIEVED TO HAVE BEEN DEVICE RELATED. IT WAS ADDITIONALLY STATED THAT IF THE DEVICE WAS BELIEVED TO HAVE BEEN THE CAUSE OF THE EVENT, THE DEVICE WOULD HAVE BEEN RETAINED FOR EVALUATION. AS PART OF INVESTIGATION OF THIS EVENT, A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS PRODUCT LINE AND HAS NOT IDENTIFIED ANY TRENDS. BASED ON THE INFO AVAILABLE, THIS EVENT DOES NOT APPEAR TO BE ATTRIBUTABLE TO THE DEVICE OR A DEVICE MALFUNCTION. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
A PT WITH CHEST PAIN PRESENTED AT THE HOSP. LAB ANALYSIS FOR CK WAS 60 U/L AND CK-MB 30 U/L USING NA HEPARIN VIALS. THESE RESULTS WERE CONFIRMED ON RE-TEST. THE PHYSICIAN QUESTIONED THE RESULTS, AND SAMPLES TAKEN ALONG WITH THE ORIGINAL WERE ANALYZED. THE RESULTS WERE APPROX 2300 U/L FOR CK-MB USING LI HEPARIN AND RED TOP SERUM VIALS. THE PT IS DECEASED, CAUSE OF DEATH MYOCARDIAL INFARCTION. NO ADD'L PT INFO IS AVAILABLE.
H3: DEVICE COULD NOT BE EVALUATED SINCE IT WAS NOT RETURNED BY USER. RETENTION SAMPLES ALSO COULD NOT BE EVALUATED SINCE REPORTER DID NOT PROVIDE LOT SPECIFIC INFO. REPORTER DID NOT WANT TO PURSUE THE EVENT.
DURING A HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT LOCK. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THE PT'S STATUS IS SATISFACTORY.
9/30/96-MEDWATCH REORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
CUSTOMER RETURNED DEVICE TO MFR WITH A NOTE ATTACHED STATING THE DEVICE DID NOT WORK. CONTACT WITH CUSTOMER REVEALED NO PT INVOLVEMENT, ISSUE OCCURRED DAILY DURING DAILY CHECK OF DEVICE. MFG PERSONNEL REPAIRED DEVICE AND CONFIRMED PROPER OPERATION.
SECTION F.10 CODE #2203-FAILURE TO PASS SELF-TEST . EXTENSIVE TESTING OF THIS DEVICE BY THE MFR COULD NOT ISOLATE ROOT CAUSE OF INTERMITTENT FAILURE. MAIN CPU CIRCUIT BOARD WAS REPLACED AND PROPER OPERATION CONFIRMED BY MFG PERSONNEL. AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE A TREND AT THIS TIME, HOWEVER, CO WILL CONTINUE TO MONITOR.
INFO ON MEDICAL DEVICE REGISTRATION FORM INDICATED THAT ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY WERE UNSUCCESSFUL DUE TO TORTUOUS ANATOMY AND LUMINAL IRREGULARITIES. DURING WITHDRAWAL OF THE DELIVERY SYSTEM AND STENT, A MINOR PLAQUE IN THE CIRCUMFLEX ARTERY WAS DISRUPTED. A PTCA WAS PERFORMED. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE SAFETY AND EFFICACY OF THE CORONARY STENT WITH DELIVERY SYSTEM HAS NOT BEEN ESTABLISHED IN PTS WITH TORTUOUS VESSELS IN THE REGION OF THE OBSTRUCTION OR PROXIMAL TO THE LESION.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT JAMMED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
INFO ON A MEDICAL DEVICE REGISTRATION FORM INDICATED THAT A CORONARY STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY. FOLLOWING SUCCESSFUL STENT PLACEMENT, THE PT DEVELOPED A SPIRAL DISSECTION DISTAL. THE PT BECAME HEMODYNAMICALLY UNSTABLE AND URGENT CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED. THE SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
VENTRICULAR PERITONEAL SHUNT PLACED FOR HYDROCEPHALUS DUE TO AQUEDUCTAL STENOSIS. REVISION OF THE SHUNT, CEPHALIC END, WAS PERFORMED DUE TO PERSISTENT DILATION OF LATEAL AND THIRD VENTRICLES CAUSING HEADACHE AND BLURRED VISION AND CONFIRMED BY CT OF HEAD. A SECOND REVISION OF THE SHUNT, CEPHALIC END, WAS PERFORMED DUE TO INEFFICIENT FLOW THROUGH THE VALVE, CONFIRMED BY SHUNT TAP. AGAIN, THE PT COMPLAINED OF HEADACHE AND BLURRED VISION. ADD'L CAT # NL850-1431L.
THE NAIL WAS REMOVED DUE TO DISLOCATION OF THE LAG SCREW. THE NAIL FRACTURED DURING THIS SURGERY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: METALLURGICAL EVALUATION OF THE NAIL IN CONJUNCTION WITH THE FEATURES OF THE FRACTURE SURFACE SUGGESTS THE NAIL FRACTURED DUE TO MATERIAL FATIGUE.
DURING A DIALYSIS TREATMENT, THE FACILITY REPORTED THAT THE FOUR-POSITION LINE CLAMPS WERE BREAKING. THERE WAS NO ADVERSE IMPACT ON THE PT TREATMENT. REPORTED TO MFR ON 7/24/96, HOWEVER, DETERMINED TO BE MDR REPORTABLE ON 9/26/96.
A REVIEW OF THE CPF/DTF HISTORIES WERE NOT POSSIBLE DUE TO AN UNK SERIAL NUMBER. THE AFECTED FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN EVALUATION. THE CUSTOMER CHOSE NOT TO RETURN THE PARTS DESPITE AN ISSUED RGA. HOWEVER, THE NATURE OF THIS COMPLAINT IS VERY SIMILAR TO THOSE OF OTHER COMPLAINTS (0896037C3, 0796207C3, 0796157C3, 0796160C3, AND 0796180C3) WHICH INVESTIGATION SHOWED THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS IN THE PREVIOUS COMPLAINTS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IT IS CONCLUDED THAT THIS COMPLAINT PROBLEM IS SIMILAR. THE ABOVE INFO INDICATES THAT THE BROKEN LINE CLAMP DESCRIBED IN THIS COMPLAINT WAS GENERATED BECAUSE OF MISUSE BY THE OPERATOR. THIS ISSUE WILL CONTINUE TO BE TREND AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES. AND/OR CORRECTIVE ACTIONS TAKEN IN THIS COMNPLAINT ISSUE WIOL BE DETERMINED BY A DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
TWO CORONARY STENTS WERE SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PT'S LEFT ANTERIOR DESCENDING ARTERY ON 4/4/96. THE PT WAS DISCHARGED FROM THE HOSPITAL FOLLOWING AN UNEVENTFUL HOSPITAL COURSE ON 4/7/96. WHILE AT HOME ON 4/9/96, THE PT BECAME APHASIC AND WAS HOSPITALIZED. DIAGNOSTIC TESTING WAS CONSISTENT WITH A CEREBROVASCULAR ACCIDENT (CVA) WITH HEMORRHAGE IN THE CEREBELLUM AND REVEALED A CLOT IN THE LEFT VENTRICLE. THE PHYSICIAN WAS UNSURE IF THE CVA WAS DUE TO THE CLOT IN THE LEFT VENTRICLE OR TO THE ANTICOAGULANT REGIMEN. THE PT WAS DISCHARGED IN STABLE CONDITION ON 4/16/96.
DURING THE INSERTION PROCEDURE, THE PHYSICIAN OBSERVED LEAKING THAT APPEARED TO BE AROUND THE CATHETER. HOWEVER, UPON HOOK UP TO THE DIALYSIS MACHINE WHEN PRESSURE WAS APPLIED IT WAS OBSERVED THAT THE LEAKING APPEARED TO BE COMING FROM THE EXTENSION TUBING ON THE CATHETER.
REPORT RECEIVED OF PARTIAL EXPLANT DUE TO J RETENTION WIRE FRACTURE WITH PROTRUSION.
PATIENT CODE @2453 - NOT LABELED. DEVICE CODE #2289 - NOT LABELED. EVALUATION OF THE INCIDENT ELECTRODE DEVICE BY CO INDICATED THAT THERE WAS BURNED/MELTED MARK ON THE INSULATION WHICH EVIDENTLY WAS COINCIDENT WITH THE PT'S BURN. THE SIZE OF THE MARK ON THE INSULATION WAS APPROX 1MM IN DIAMETER, LOCATED 4.25" FROM THE ELECTRODE TIP AND HAD THE APPEARANCE OF AN BURN MARK ON THE METAL ELECTODE SHAFT WITH THE INSULATION MELTED AROUND IT, INDICATING FROM EXPERIENCE THAT AN RF ARC HAD OCCURRED. ALL OTHER AREAS OF THE ELECTRODE WERE NORMAL EXCEPT THAT THE INSULATION HAD DISCOLORED POSSIBLY FROM STERILIZATION PROCESSING. THE SAMPLE RETURNED WAS SUBJECTED TO THE CO ENGINEERING QUALIFICATION TEST FOR HIGH FREQUENCY LEAKAGE CURRENT TEST PER ANSI/AAMI HF18 PARA 4.2.5.2. ADDITIONALLY THE SAMPLE WAS SUBJECTED TO A STIMULATION OF HIGH VOLTAGE (HV) USAGE WHERE THE ELECTRODE WAS CONNECTED TO THE COAG OUTPUT OF AN ESU AT 30W AND AGAIN AT 120 W. WITH NO LOAD ON THE ELECTRODE THE INSULATED SHAFT WAS MOVED IN PROXIMITY TO (AND EVENTUALLY TOUCHING) AN ELECTRODE TIP CONNECTED THROUGH A 300 OHM (PATIENT LOAD) LOAD ATTACHED TO THE PT RETURN. THE SAMPLE WAS VISUALLY EXAMINED PRIOR TO AND FOLLOWING THE TESTING FOR ANY INDICATION OF INSULATION DEFECTS. THE SAMPLE PASSED THE TWO TESTS WITH NO INDICATIONS OF ANY INSULATION BREAKDOWN. VISUAL EXAM AT 1:1 AND UNDER A MICROSCOPE  AT 4.5 X MAGNIFICATION, INDICATED THE ORIGINAL BURN MARK ON THE SAMPLE HAD THE SAME CHARACTERISTICS AS THE MARKS CREATED BY THE ARCS AT THE PIN HOLE LOCATIONS AND WERE CONSISTENT WITH INSULATION BREAKDOWN. THE CONCLUSION REACHED BY CO WAS THE INCIDENT DEVICE APPARENTLY HAD A RANDOM DAMAGED INSULATION AREA OF UNKNOWN ORIGIN WHICH CREATED THE BREAKDOWN UNDER USE, RESULTING IN THE PT INJURY TO THE BOWEL. CO REGRETS THE INCIDENT OCCURRED AS A RESULT OF THIS INSULATION DAMAGE, HOWEVER THESE DEVICES ARE VISUALLY EXAMINED FOR SEVERAL DETAILS DURING PRODUCTION AND ANY PIN HOLE LIKE DAMAGE DETECTED WOULD HAVE BEEN CAUSE FOR REJECTION. A REENFORCEMENT OF THE CRITERIA WITH THE MANUFACTURING/QC OPERATORS HAS BEEN CONDUCTED. THE USER SHOULD BE AWARE HOWEVER, THAT WHEN STERILIZED THE MATERIAL WILL SOFTEN SOMEWHAT WITH THE HEAT AND THE INSULATION IS SUSCEPTIBLE TO NICKS AND CUTS IF NOT HANDLED CAREFULLY.
PT ON CBP. AT END OF CASE, SMALL PLASMA LEAK INTO GAS CHAMBER WAS NOTICED.
THE DEVICE WENT TO END OF SVC WITHOUT EVER REACHING ITS INTENSIFIED FOLLOW-UP INDICATOR (IFI). ON 7/2/96, TRANSTELEPHONIC CHECK SHOWED EVERYTHING FINE. ON 7/10/96, THE PT CALLED TO REPORT SYMPTOMS AND THE TRANSTELEPHONIC INDICATED THE DEVICE HAS REACHED ITS ELECTIVE REPLACEMENT INDICATOR. IN THE OR ON 7/11/96, THE DEVICE WAS AT VVI PACING AT 30, WHEN IT WAS PROGRAMMED TO 55 PPM. HOWEVER, THE NURSE IS NOT SURE IT THAT IS CORRECT. THE DEVICE IS TO BE RETURNED.
PREVIOUSLY REPORTED AS INTER ELECTRODE REGION KINKED WITH WIRE FRACTURE NOT SUSPECTED. THE LEAD WAS EXPLANTED.
THIS ENTIRE FORM COMPLETED BY MFR. PREVIOUSLY REPORTED UNDER FDA ACCESSION NUMBER M-752688.
DURING AN EVAL, THE NURSE WAS PREPARING THE SECONDARY MEDICATION AND IT WAS NOTED THAT THE SECONDARY WAS BACKING UP INTO THE PRIMARY LINE.
THE SAMPLE WAS DISCARDED AND NOT RETURNED FOR EVAL, THERFORE THE ROOT CAUSE FOR THE BACK FLOW COULD NOT BE DETERMINED. THE LOT HISTORY FILE WAS REVIEWED AND NO DEFECTS WERE NOTED RELATED TO THE REPORTED PROBLEM. SECTION A, B AND F WERE COMPLETED BY THE MFR. INFO WAS NOT AVAILABLE FOR SECTIONS A-14 AND B-4,6,7 AND F-2,6,8,10. THERE WAS NO PT INJURY THEREFORE THE FACILITY DID NOT FILE A REPORT. MFR'S REPORT DATE 9/25/96 FILE #08-96-155.
A LENS REPLACEMENT AND A CORNEAL TRANSPLANT WERE PERFORMED DUE TO CORNEAL SWELLING.
EVALUATION RESULTS: THE LENS WAS RETURNED WITH EVIDENCE OF SURGICAL RESIDUE. THE LENS CONFORMS TO DESIGN SPECIFICATIONS.
RESIDENT FOUND ON FLOOR IN HER ROOM LYING ON L SIDE. DEVICE CORD FOUND ATTACHED TO RESIDENT'S SHIRT, MONITOR ATTACHED TO HER BED BUT DID NOT ACTIVATE. UNIT HAD FUNCTIONED PROPERLY SEVERAL TIMES THAT EVENING AS RESIDENT ATTEMPTED TO GET UP. FALL RESULTED IN SUBCAPITAL L HIP FX. RESIDENT SENT TO HOSP FOR SURGICAL PINNING.
THE CATHETER WAS PLACED ABOUT 1 MONTH BEFORE THE INCIDENT. AN X-RAY WAS TAKEN AT PLACEMENT WHICH SHOWED IT TO BE IN PLACE. ON 8/22/96, THE PT CAME TO THE HOSPITAL SUFFERING FROM DEHYDRATION. AN X-RAY WAS TAKEN WHICH SHOWED THE CATHETER HAD DISLODGED FROM THE EPIDURAL SPACE.
THE CATHETER WAS REMOVED ON 8/23/96. A DEVICE HISTORY REVIEW AND COMPLAINT HISTORY REVIEW WERE NOT POSSIBLE, AS NO LOT NUMBER WAS PROVIDED BY THE FACILITY. THE CATHETER IS CURRENTLY BEING RETAINED BY THE HOSPITAL.
DURING ROUTINE TESTING, THE USER DISCOVERED THAT THE DEFIBRILLATOR WOULD NOT POWER UP. THERE WAS NO PT INVOLVED.
THE HIGH VOLTAGE MULTIPLIER (T102) ON THE MONITOR P.C. BOARD ASSEMBLY WAS DRAWING UNUSUALLY HIGH CURRENT. THAT CAUSED A RESISTOR (R156), A DIODE (CR113) AND AN INDUCTOR (L1) TO OVERHEAT. THIS APPEARS TO BE AN ISOLATED COMPONENT FAILURE, AND NO ADD'L ACTION IS ANTICIPATED. THE EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.
EVAL TO BE COMPLETED UPON RETURN OF ELECTRODES IN QUESTION.
MD REMOVED DEVICE (SURGICALLY) BECAUSE IT WAS NOT WORKING. NO FURTHER INFO IS AVAILABLE.
DEVICE HAS NOT YET BEEN RECEIVED BY CONTRACT MFR. 9/27/96.  DISCLAIMER STATEMENT: NEITHER THE FILING OF THIS MEDICAL DEVICE REPORT NOR THE INFO CONTAINED HEREIN SHALL BE CONSTRUED AS AN ADMISSION OR ACKNOWLEDGEMENT EITHER THAT THE INFO SUBMITTED TO HORIZON MEDICAL PRODUCTS, INC. IS VALID OR THAT THE DEVICE CAUSED OR CONTRIBUTED IN ANY WAY TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED.  THE FREQUENCY OF THIS EVENT DOES NOT APPEAR TO BE INCREASING. THE SEVERITY IS NOT INCREASING. THE REASON FOR THE EXPLANT PROCEDURE IS UNK.
THE FEMORAL HIP PROSTHESIS EXTRACTION INSTRUMENT BROKE DURING SURGERY. SURGERY WAS PROLONGED AS A RESULT, HOWEVER, NO INJURY TO THE PT WAS REPORTED.
WHILE ATTEMPTING TO RETRIEVE A STENT FROM A URETER, ONE OF THE METAL GRASPING ARMS OF THE FORCEP BROKE OFF. THE PT URETER WAS IRRIGATED AND AN X-RAY TAKEN WHICH WAS VIEWED AS NEGATIVE BY THE SURGEON AND CONFIRMED BY THE RADIOLOGIST.
THE PORT WAS PLACED 11/93 FOR CHEMOTHERAPY. DURING AN EXAMINATION IN 1996, THE CATHETER WAS FOUND TO HAVE SEPARATED FROM THE PORT AND MIGRATED INTO THE PT'S VASCULAR SYSTEM NEAR THE LUNGS. THE PORT AND CATHETER WERE REMOVED.
THE PRODUCT CODE AND LOT NUMBER WAS RECENTLY PROVIDED TO THE MFR BY THE PT. THE DEVICE HISTORY REVIEW SHOWED NO RELATED MFG ISSUES AND ONE COMPLAINT OF SIMILAR NATURE WHICH WAS INCONCLUSIVE AS NO PRODUCT HAD BEEN FORWARDED FOR EVALUATION.
THE INSTRUMENT WAS USED DURING A RESECTION OF ZENKERT DIVERTICULUM. IT WAS REPORTED THE EZ35W WAS FIRED, THEN THE CARTRIDGE FELL OUT OF THE HAWS OF INSTRUMENT. STAPLES WERE NOT FORMED. ANASTOMOSIS WAS COMPLETED WITH SUTURE. NO BUTTRESSING MATERIAL USED. 8/21/96 THE DEVICE CUT AND FIRED, BUT THE STAPLE LINE FELL APART. THIS OCCURRED ON THE FIRST FIRING. THERE WAS NO CONSEQUENCE TO THE PT.
CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY PRODUCED "MALFORMED STAPLES" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE CARTRIDGE RETENTION FEATURE WAS MEASURED AND WAS FOUND TO BE CONFORMING. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
DEVICES WERE USED DURING A LAPAROSCOPIC CHOLECCYSTECTOMY PROCEDURE AND THE CASE WAS COMPLETED UNEVENTFULLY. POST SURGERY, THE PT'S VITAL SIGNS BEGAN DROPPING WHILE IN RECOVERY. A LAPAROTOMY WAS PERFORMED AND PERFORATIONS TO THE ILEUM AND AORTA WERE REPAIRED. THE PT WAS SENT HOME WITHOUT FURTHER COMPLICATIONS.
H3: DEVICE EVALUATED BY MFR? EXPLANATION FOR CODE "00". THE ACCOUNT HAS NOT FILED A COMPLAINT IN RESPONSE TO THIS EVENT AND HAS DISCARDED THE INVOLVED INSTRUMENT. H10: CO BECAME AWARE OF THE EVENT THROUGH A ROUTINE SALES CALL. THE HOSP WAS NOT CERTAIN HOW OR WHICH DEVICE MIGHT HAVE CAUSED THE VASCULAR PERFORATIONS. HOWEVER, SINCE CO WAS ADVISED THAT BOTH ITS TROCAR AND PNEUMO NEEDLE WERE USED IN THE CASE, CO IS REPORTING BOTH DEVICES. THE CO ANTICIPATES NO FURTHER SUBMISSIONS.  IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING? NO. IS FREQUENCY GREATER FOR THIS EVENT THAN USUAL? NO. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING? YES. IS SEVERITY GREATER FOR THIS EVENT THAN USUAL? NO.
CASE WAS A PNEUMONECTOMY/THORACOTOMY. LINEAR STAPLER WAS USED TO CLOSE THE VEIN, RELOADED AND USED TO CLOSE THE PULMONARY ARTERY. PT WAS BLEEDING PROFUSELY AND STAPLER WAS FOUND TO HAVE UNFORMED STAPLES REMAINING IN CARTRIDGE. MFG REP ASSISTED IN TESTING DEVICE. INDETERMINATE AS TO WHETHER DEVICE OR CARTRIDGE WAS AT FAULT. OPERATOR CONFIRMED PROPER USE. PT POSSIBLY REQUIRED EXTRA FLUID/BLOOD FOR HYPOTENSION. PT RECOVERED, DISCHARGED FROM HOSP.
ABUTMENT SCREWS WERE MISSING. DURING INVESTIGATION OF RETURNED PARTS IT WAS NOTED THAT BOTH ABUTMENTS ARE BROKEN. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENTS THEMSELVES. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORIES OF THE SUBJECT PRODUCTS COULD NOT BE COMPLETED SINCE THE LOT NUMBERS WERE NOT AVAILABLE FROM THE DOCTOR'S OFFICE.
THE PUMP DELIVERED OVER THE AMOUNT PRESCRIBED (BOLUS DELIVERY). THE REPORTER FURTHER STATED THE PT PULLED THE PUMP OVER. THERE WAS NO ILLNESS, INJURY OR MEDICAL ITNERVENTION RESULTING FROM THE EVENT. NO FURTHER DETAILS WERE PROVIDED.
WHEN THIS OPHTHALMIC MICROSURGICAL ACCESSORY PACK WAS OPENED FOR USE PRIOR TO A CATARACT EXTRACTION PROCEDURE, THE NEEDLE INCLUDED IN THE PACK WAS MISSSHAPED. THE PACK WAS SET ASIDE AND ANOTHER PACK WAS USED FOR THE PROCEDURE.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. IT WAS REPORTED IN USING THE ER320 TO LIGATE GASTRIC HEPATIC AND SHORT GASTRIC VESSELS, THE CLIPS SEEMED TO SLIDE OFF. THEY LOOKED LIKE THEY APPLIED PROPERLY, BUT THEN IT STARTED TO BLEED AND THE CLIPS WERE NOT ATTACHED. SOME INITIALLY DID NOT FORM. TWO ER320'S WERE USED. TO COMPLETE THE LIGATION A LOT OF CAUTERY WAS USED. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: DEVICE RETURNED EMPTY. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INTRUMENTS WERE RETURNED EMPTY AND LOCKED OUT. NO TESTING COULD BE PERFORMED AS THE INSTRUMENTS WERE RETURNED EMPTY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
PT WITH BPH UNDERGOING TRANSURETHRAL ELECTROVAPORIZATION OF PROSTATE. "POP" WAS HEARD DURING PROCEDURE. PT WAS TAKEN TO OR FOR SUPRAPUBIC EXPLORATION/ BLADDER REPAIR/CYSTORRAPHY FOR RUPTURED BLADDER.
AN IMPLANT FAILED. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO WAS UNABLE TO REVIEW THE PRODUCT'S LOT HISTORY SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR'S OFFICE.
10-15-96 DR. PERFORMED A RIGHT HEMI-COLECTOMY. HE DID A FUNCTIONAL END-TO-END ANASTOMOSIS USING A LINEAR CUTTER OR A GIA, HE DOES NOT KNOW WHICH. HE CLOSED THE OPENINGS WITH THE TL60. DURING THE POST OPERATIVE PERIOD THE PATIENT DEVELOPED A LEAK. THE PATIENT WAS REEXPLORED AND ILIOSOTMY WAS PERFORMED. THERE WERE SOME OPEN STAPLES PRESENT. THESE WERE NOT SAVED. THERE IS NO MATERIAL FOR CO'S EVALUATION. THE PATIENT HAS HAD A VERY SEPTIC COURSE, BUT HAS SHOWN SOME IMPROVEMENT OVER THE PAST FEW DAYS.
THE STAPLER WAS USED DURING AN LAVH. THE DEVICE MISFIRED. REP THEN SPOKE WITH DR WHO REPORTED SOME BOWEL HUNG UP ON A STAPLE. THIS WAS NOTED AFTER COMPLETING VAGINAL PORTION OF PROCEDURE AND THE BOWEL WAS RELEASED AT THAT TIME. PHOTOS OF THE BOWEL ON THE STAPLE ARE AVAILABLE. THERE WAS NO CONSEQUENCE TO THE PT.
O08/7/96, 1020 ATTEMPTED TO REACH SURGEON. OFFICE WAS CLOSED. WILL CALL LATER. 8/7/96, THE PT HAS UNDERGONE A LAPAROSCOPIC ASSITED VAGINAL HYSTERECTOMY. TIME OF SURGERY THERE WERE NOTED TO BE STAPLES, HE DID NOT NOTICE ANY MALFORMATION, HOWEVER LATER IN THE CASE THERE APPEARED TO BE PARTIALLY FREE STAPLES THAT WERE INVOLVED WITH THIS PHENOMENON. THERE WAS NO CONSEQUENCE TO THE PT. THERE ARE PHOTOS OF THIS. THERE IS NO INSTRUMENTATION STAPLES OR VIDEOS TO REVIEW. RISK MGR DID NOT HAVE ANY INFO ON THIS EVENT. SHE WILL GET ADD'L INFO AND FAX IT TO CO.
8/22/96 PT FELL ON WIRE DOGCAGE AND HIT HER RIGHT CHEST. SHE FELT IMMEDIATE SEVERE PAIN AND THE IMPLANT FELT SOFTER. PT ALSO HAS GRADE III CAPSULAR CONTRACTURE ON THE LEFT AND GRADE II CAPSULAR CONTRACTURE ON THE RIGHT WITH ECCHYMOSIS.
WHILE THE PHYSICIAN WAS USING THIS INSTRUMENT, TIP BROKE OFF.
SECTIONS A-F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. TIPS ARE BROKEN OFF AND INSTRUMENT IS BEYOND REPAIR. CAUSE FOR BREAKAGE IS NOT KNOWN.
PT USING DEVICE VAGINALLY TO RESTORE MUSCLE TONE. STATES SHE "FELT A JOLT." PHYSICIAN REPORTS HER TISSUE IS BURNED AND PERMANENT STITCHES DISRUPTED.
THE DEVICE WAS IMPLANTED FOR INFUSION OF FUDR THROUGH THE HEPATIC ARTERY FOR TREATMENT OF CANCER. ON 9/9/96, A FACILITY NURSE CONTACTED A MFR NURSE AND REPORTED THAT ANOTHER MFR NURSE HAD BEEN PRESENT AT THE FACILITY EARLIER THAT DAY TO DO A REFILL INSERVICE. THE FACILITY NURSE STATED THAT SHE HAD ACCESSED THE DEVICE CENTER SEPTUM WITHOUT DIFFICULTY AND PERFORMED THE DEVICE REFILL. THE DEVICE SIDEPORT WAS ACCESSED FOR A 2-1/2 HR INFUSION. THE DEVICE WAS THEN FLUSHED AND HEPARINIZED WITH 10,000U/CC HEPARIN. THE FACILITY NURSE STATED THAT SHE DID NOT REALIZE HER ERROR UNTIL CHARTING AND REVIEWING HER NOTES WHEN SHE SAW THAT SHE WAS TO USE 100U/CC HEPARIN. THE PT HAD ALREADY GONE HOME AT THAT TIME. THE FACILITY NURSE THEN INQUIRED WHAT EFFECT THIS WOULD HAVE ON THE DEVICE, WHY ARE THE TWO DIFFERENT CONCENTRATIONS USED, AND WHAT SHE NEEDED TO DO NOW. THE MFR NURSE RECOMMENDED THAT SHE CONTACT THE PHYSICIAN IMMEDIATELY. THE MFR NURSE THEN STATED THAT THERE SHOULD BE NO EFFECT ON THE DEVICE AND EXPLAINED THAT THE HIGHER CONCENTRATION OF HEPARIN USED IN THE DEVICE IS DILUTED BY THE 50CC VOLUME AND DELIVERS 1,000U/CC SLOWLY OVER TIME (ABOUT 2CC/DAY), WHILE THE DRUG GIVEN THROUGH THE DEVICE SIDEPORT GOES TO THE PT IMMEDIATELY. THE DEVICE SIDEPORT AND CATHETER VOLUME IS APPROX. 0.9ML.
ON 10/16/96, THE MFR SALES REPRESENTATIVE REPORTED THAT SHE HAD FOLLOWED UP WITH THE FACILITY CONCERNING THIS PT'S CONDITION IN REGARDF TO THE HAPARIN OVERDOSAGE AND SHE WAS INFORMED THAT THE PT IS DOING " JUST FINE" AND AHD NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THE ACCIDENTAL ADMINISTATION OF THE INCREASED HEPARIN DOSAGE. NO FURTHER DETAILS ARE AVAILABE. THE MFR IS NOW CLOSING ITS FILE ON THIS REPORT. (NOTE: THIS REPORT ADDRESSES ONLY THE ISSUE OF THE HEPARIN OVERDOSAGE.
LICENSED NURSE HAD GIVEN THIS RESIDENT AN ENEMA. THE NURSING ASSISTANT WENT OUT FOR TOWELS AND UPON HER RETURN NOTED A LARGE AMOUNT OF BLOOD ON THE BED AND FLOOR. RESIDENT HAD A VERY DEEP LACERATION ON THE INNER ASPECT OF THE RIGHT CALF (3" X 12"). RESIDENT HAD CUT HERSELF ON THE RELEASE BUTTON OF THE BED RAILS.
WARMING BLANKET BURNED PT'S CALVES. SECOND DEGREE BURNS TO R LEG 4 1/2" X 3", L LEG 3 1/2" X 2".
A PT PRESENTED WITH TISSUE DEHISCED LEAVING 5MM OF TISSUE EXPOSED, CONTAMINATING IMPLANT. PT IS REPORTEDLY FINE.
THE PT WAS PLACED IN A VEST RESTRAINT IN ACCORDANCE WITH THE MFR'S INSTRUCTIONS, AND THEN CHECKED APPROPRIATELY. WHILE NO ONE WAS IN THE ROOM, THE PT APPARENTLY ATTEMPTED TO FREE HERSELF FROM THE RESTRAINT AND EXIT THE BED. SHE WAS FOUND UNCONSCIOUS SITTING ON THE FLOOR, AGAINST THE SIDE OF THE BED, WITH A STRAP FROM THE RESTRAINT ACROSS HER THROAT.
THE DEVICE WAS USED DURING A RADICAL PROSTATECTOMY. THE EZ45G DID NOT WORK PROPERLY. ANOTHER EZ45G WAS OPENED TO COMPLETE THE CASE. NO BUTTRESSING MATERIAL USED. THERE WAS NO CONSEQUENCE TO THE PT.
EES #964120. 8/15/96 1205 SPOKE TO SURGEON. HE STATED THE EZ45 FIRED AND IT WOULD NOT OPEN. THE SURGEON HAD TO MANUALLY PULL THE INSTRUMENT APART. THE STAPLE LINE WAS INTACT, BUT IT DID NOT CUT. THE SURGEON USED SCISSORS TO COMPLETE THE CUT LINE. ANOTHER EZ45 WAS OPENED TO COMPLETE THE CASE AND WORKED FINE. RESULTS OF EVALUATION: CONCLUSION: NO ANALYSIS COULD BE PERFORMED SINCE NO INSTRUMENT WAS RECEIVED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THIS EVENT TO OCCUR.
ON 10/16/96, THE MFR SALES REP REPORTED THAT THE DEVICE FLOW RATE HAD INCREASED TO 1.3-1.4ML/DAY AND THE FACILITY WAS PLANNING TO REFILL THE DEVICE AGAIN THE FOLLOWING WEEK. ON 10/31/96, THE MFR SALES REP REPORTED THAT THE DEVICE WAS REFILLED ON 10/23/96 AND THE DEVICE FLOW RATE WAS NOW 1.39ML/DAY. THE PHYSICIAN HAS ADJUSTED THE DOSAGE OF FUDR TO COMPENSATE FOR THE DECREASED FLOW RATE AND FEELS THAT EVERYTHIN IS "OKAY". THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN. SINCE THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN, THE MFR INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PART/SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS PART/SERIAL NUMBER AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS PART NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS REPORT.
A RESIDENT WHILE BEING TRANSFERRED FROM HER BED TO A WHEELCHAIR, VIA A HOYER LIFT, FELL TO THE FLOOR AND SUSTAINED A SMALL LUMP TO THE BACK OF HER HEAD. SHE WAS TRANSFERRED TO EMERGENCY DEPT WHERE A CAT SCAN WAS DONE WHICH WAS NEGATIVE, AND HER CONDITION WAS LISTED AS STABLE. APPROXIMATELY 12 HRS LATER THE WOMAN DIED BUT AN AUTOPSY DONE SHOWED CAUSE OF DEATH WAS PULMONARY CONGESTION SECONARY TO HYPERTENSION AND CARDIOVASCULAR DX. NO BLEED EVIDENCE.
CO'S EVALOF THE RETURNED PRODUCT SHOWED THAT THE DISTAL END OF THE SEPARATED SHEATH PROBOBALY DUE TO OCCLUSIVE PRESSURE APPLIED OVER THE PRODUCTS SHEATH. CODE 86: A REVIEW OF THE MANUFACTURING AND QC RECORDS SHOWED NO DEVIATIONS FORM SPECIFICATION. CODE 68; THE PRODUCT SHEATH IS DESIGNED TO DELIVER COLLAGEN THROUGH  AN UNRESTRICTED PADDAGE. COMPRESSION OF THE DISTAL END OF THE SHEATH WOULD RESTRICT THE PASSAGE OF COLLAGEN. CONTINUED ATTEMPTS TO DELIVER THE COLLAGEN CAN FORCE THE SHEATH TO SEPARATE FROM THE HAB . THE IFU STATES THAT IF EXCESSIVE RESISTANCE IS ENCOUNTERED WHILE DELIVERING THE COLLAGEN PLUGS, DISCONTINUE THE PROCEDURE. IN ADDITION IT INSTURCTS THE USER TO OCCLUSIVELY COMPRESS FAR ENOGUH ABOVE THE ARTERIAL PUNCTURE  TO AVOID KINKING THE SHEATH.
THIS INFO WAS REC'D AS A CUSTOMER COMPLAINT. THE DAMAGED PIECES OF THE DEVICE WERE PROVIDED WITHOUT DETAILS TO THE PROCEDURE. IT WAS REPORTED THAT THE SHEATH SEPARATED DURING THE PROCEDURE. CO'S EVAL FOR THE RETURNED PRODUCT IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILLED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. OUTSIDE SHAFT AT TIP HAS SOME MATERIAL BROKEN OFF. TIP OF PUNCH IS BENT. THE MATERIAL MAY HAVE BROKEN OFF WHEN THE HANDLE WAS SQUEEZED WHEN OPERATED. THE CAUSE FOR THE BEND IS NOT KNOWN.
DURING A CATARACT EXTRACTION PROCEDURE, THIS INSTRUMENT BROKE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT'S EYE. THERE WERE NO PATIENT PROBLEMS.
GUIDEWIRE WAS USED TO PLACE ANOTHER MFR'S CORONARY STENT IN AN LAD LESION. IT WAS USED TO GUIDE A BALLOON CATHETER TO AN RCA LESION FOR DILITATION. UPON REMOVAL OF THIS DEVICE, THE DISTAL END UNCOILED AND THE TIP OF THE GUIDEWIRE BROKE OFF IN THE DISTAL RCA.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. THE EZ35B DID NOT CLAMP AND DID NOT CUT. THERE WAS NO CONSEQUENCE TO THE PT.
F1: SHOULD NOT HAVE BEEN CHECKED ON INITIAL MEDWATCH. NO MEDWATCH WAS RECEIVED BY USER FACILITY. H4: INFO NOT AVAILABLE H6: CODE 400 (OTHER): DAMAGED FIRING MECHANISM G3: CONSUMER WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH CONCLUSION BASED UPON INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT WAS RETURNED NON-FUNCTIONAL. INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS SOME CONSITONS WHICH MIGHT RESULT IN DAMAGE TO FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE ITS PRODUCTS.
THE BALLOON OF THIS DEVICE LEAKED DURING PREP. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR ANALYSIS.
ROD BROKE AT THE DISTAL MOST PROXIMAL SCREW HOLE DUE TO NONUNION AT THE FRACTURE SITE. THE ROD WAS REMOVED AND REPLACED. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVALUATION: THE ALTA FEMORAL ROD BROKE IN FATIGUE DUE TO THE PATIENT'S NONUNION OF THE PROXIMAL FEMORAL FRACTURE. THE DEVICE HISTORY RECORD FOR THE LOT CODE OF THE RETURNED ROD WAS REVIEWED AND NO DISCREPANCIES WERE OBSERVED.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. SURGEON APPLIED THE STAPLER TO CREATE A RECTAL STUMP. UPON REMOVAL THERE WERE NO STAPLES NOTICED. THE ANASTOMOSIS WAS COMPLETED WITH HAND SUTURE. THE EXCISION WAS BETWEEN THE STAPLER (RECTAL END) AND THE CLAMP (SPECIMEN END). THERE WAS NO CONSEQUENCE TO THE PT. 8/26/96 DR STATED "THE SPECIMEN REPORT SHOWED UNFORMED STAPLES FOUND ON 1/3 OF THE STAPLE LINE WITH 2/3 OF STAPLE LINE MISSING FROM SPECIMEN. THERE DID NOT APPEAR TO BE ANY DIFFICULTY IN CLOSING THE INSTRUMENT BEFORE FIRING. THE STEPS OF CLOSURE OF THE STAPLER WERE OBSERVED BY FIRST CLOSING THE WHITE TRIGGER AND FOLLOWED BY THE BLACK TRIGGER TO FIRE.
D10-INFO NOT PROVIDED BY AFFILIATE. F1: SHOULD NOT HAVE BEEN CHECKED ON INITIAL MEDWATCH. NO MEDWATCH WAS RECEIVED BY USER FACILITY. D5: H4-INFO NOT AVAILABLE G3: CONSUMER WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH. BASED UPON INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED REPORTED INCIDENT. IT COULD NOT BE ASCERTAINED AS TO WHERE OR WHEN STAPLES HAD BEEN FIRED. IT SHOULD BE NOTED THAT ADEQUATE INSPECTION AND CONTROL POINTS EXIST IN MFG LINE ALONG WITH A LASER VISION INSPECTION SYSTEM THAT DETECTS MISSING STAPLES AND EMPTY INSTRUMENTS. IT SHOULD BE NOTED THAT STRINGENT INSPECTION AND CONTROL POINTS EXIST IN MFG LINE ALONG WITH A LASER INSPECTION SYSTEM THAT DETECTS MISSING STAPLES AND EMPTY INSTRUMENTS. THE STAPLE LOADING PROCESS WAS REVIEWED AND DEMONSTRATED A VERY HIGH DEGREE OF RELIABILITY. ALL EMPLOYEES ASSOCIATED WITH ASSEMBLY OF THIS INSTRUMENT HAVE BEEN INFORMED OF THIS REPORTED INCIDENT.
THE HEAD OF THE SHAFT COMPONENT OF THE LOCKING WRENCH STRIPPED DURING SURGERY. THE SURGERY WAS PROLONGED AS A RESULT OF THIS OCCURRENCE. THERE WAS NO INJURY TO THE PT. NO OTHER INFO WAS PROVIDED TO CO.
THE BALLOON OF THIS DEVICE FAILED TO INFLATE AT PREP. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR ANLAYSIS.
PATELLA COMPONENT DELAMINATED, WHITE AND POROUS.
THE SURGEON REPORTED THAT AFTER ATTEMPTS TO SEAT TWO DIFFERENT TIBIAL INSERTS INTO THE TIBIAL BASE, HE ELECTED TO IMPLANT AN ALL POLYETHYLENE TIBIAL COMPONENT INSTEAD. NO INJURY TO THE PT WAS REPORTED.
INSPECTION OF FOUR (4) OF THE EIGHT PARTS IN LOT #0703891 REVEALED THAT 3 OUT OF 4 WERE OUT OF TOLERANCE ON ONE DIMENSION. INSPECTION OF LOTS MANUFACTURED AFTER THE DISCREPANT LOT WERE FOUND TO BE IN TOLERANCE. THE REMAINING 4 PIECES FROM LOT #60703891 WERE LOCATED IN DISTRIBUTOR INVENTORY AND WERE REQUESTED TO BE RETURNED FOR INSPECTION.
ON 9/10/96, THE MFR RECEIVED A RESPONSE TO A DEVICE TRACKING POLLING LETTER. THE RESPONSE FROM THE PT'S WIFE STARTED THAT THE PT EXPIRED ON 3/8/96. IT ADD'L STATED THAT, WHETHER IT WAS SURGEON ERROR OR OTHER COMPLICATIONS, THEY DID NOT FEEL THAT THE DEVICE WAS SUCCESSFUL. THE FIRST DEVICE WAS STATED TO HAVE BEEN IMPLANTED IN 4/95. DURING THE LATER PART OF 9/95, THE PHYSICIAN INFORMED THE PT THAT THE DEVICE NEEDED "STRIPPING". AS A RESULT, THE PT WAS ADMITTED TO ANOTHER FACILITY FOR ONE DAY SURGERY. THE PHYSICIAN STATED THAT THE TOP PART OF THE DEVICE WAS BROKEN SO HE HAD TO PUT A NEW ONE IN.
ON 9/25/96, THE MFR RECEIVED A LETTER FROM THE PHYSICIAN WHICH STATES THAT THE PT'S MALIGNANCY PROGRESSED ON FIRST LINE FUDR AND 5FU CHEMOTHERAPY. IT ADDITIONALLY STATES THAT THE PHYSICIAN BELIEVES THAT THE PT WAS CHANGED TO A SECOND LINE REGIMEN UNDER THE DIRECTION OF ANOTHER PHYSICIAN. IN SEPT OF 1995, THE PT CONTINUED TO COLLECT FLUID WITHIN HIS PUMP POCKET AND HIS SIDEPORT WAS FOUND TO BE NONFUNCTIONAL. THE PHYSICIAN EXPLORED THE PT, REMOVED THE PUMP, AND FOUND THE SIDEPORT SEPTUM TO BE PARTIALLY AVULSED. THE PUMP WAS REPLACED AND THE PT WAS CONTINUED ON CHEMOTHERAPY. THE PHYSICIAN DOES NOT BELIEVE THAT THE MALFUNCTION OF THE DEVICE CONTRIBUTED TO THE PT'S DEATH, BUT RATHER THAT IT WAS THE PT'S DISEASE THAT WAS UNRESPONSIVE TO CHEMOTHERAPY. AS PART OF INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MANUFACTURING VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. BASED ON THE INFO AVAILABLE, AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NEITHER THE PT'S DEATH OR THE UNSUCCESSFULNESS OF THE CHEMOTHERAPY APPEAR TO BE RELATED TO THE DEVICE OR A DEVICE MALFUNCTION; HOWEVER, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE AVULSED SEPTUM. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR'S OFFICE.
THE DEVICE WAS IMPALNTED FOR THE INTRATHECAL INFUSION OF MORPHINE FOR TREATMENT OF PAIN. ON 9/11/96, THE MFR'S DISTRIBUTOR INFORMED THE MFR OF AN INCIDENT WHICH HAD OCCURRED AT A FACILITY IN THEIR TERRITORY. THE REPORT STATES THAT THIS IS THE SECOND DEVICE THAT HAS BEEN IMPLANTED INTO HIS PT. ACCORDING TO THE PHYSICIAN, THE DEVICE STOPPED PROVIDING PAIN RELIEF FOR THE PT. AS A RESULT, THEY DECIDED TO EXPLANT THE DEVICE. IT WAS ADDITIONALLY STATED THAT THERE WAS A QUESTION OF CATHETER BLOCKAGE AND FUNCTIONING OF THE DEVICE. THE DEVICE IS SCHEDULED TO BE RETURNED TO THE MFR FOR ANALYSIS; HOWEVER, THE DEVICE HAS NOT BEEN RETURNED TO DATE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.
DEVICE WAS RETURNED TO MFR AND HAS BEEN ANALYZED AS FOLLOWS: NORMAL USAGE WAS INDICATED ON CENTER AND SIDEPORT SEPTA NO ANOMALIES INCLUDING INTERNAL DAMAGE WAS NOTED. DEVICE SIDEPORT/CATHETER WAS PATENT AND DID NOT LEAK. SOME RESISTANCE WAS FELT WHEN FLUSING SIDEPORT/CATHETER AND CLOUDY FLUID WITH WHITE PARTICLES WAS COLLECTED. DEVICE DID NOT FLOW AS RECEIVED OR AFTER CUTTING APPROX 1/2 OF TOTAL LENGTH OF DEVICE CAPILLARY TUBING. DISTALEND OF DEVICE CAPILLARY TUBING WAS OCCLUDED WITH MATERIAL INDENTIFIED AS MORPHINE USING FOURIER TRANSORM INFRA RED (FTIR) ANALYSIS. LEAK TESTING OF DEVICE CONFIRMED THAT DEVICE DID NOT LEAK. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT FOR THIS DEVICE. BASED ON INFO AVAILABLE AND RESULTS OF MFR'S ANALYSIS, COMPLAINT OF "DEVICE BLOCKAGE" HAS BEEN CONFIRMED. CAUSE OF DEVICE BLOCKAGE APPEARS TO BE TO MORPHINE PRECAPITATE. NO FURTHER INFO IS AVAILABLE. CUSTOMER WILL BE NOTIFIED OF CO'S FINDINGS. MFR IS NOW CLOSING FILE ON THIS EVENT.
AN IMPLANT FAILED DUE TO INFECTION. PT IS REPORTEDLY FINE.
THE BALLOON OF THIS DEVICE FAILED TO INFLATE AT PREP. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR ANALYSIS.
PT WAS TAKEN TO OR FOR PLACEMENT OF VENA CAVA FILTER FOR DVT AND GI BLEED PROHIBITING SYSTEMIC ANTICOAGULATION. UNDER LOCAL SEDATION, A .025 INCH GUIDEWIRE WAS ADVANCED DOWN AN INDWELLING TRIPLE LUMEN. THE TRIPLE LUMEN WAS REMOVED AND INITIAL SMALLER DILATOR WAS ADVANCED OVER THE WIRE. THE .025 WIRE WAS EXCHANGED FOR .038 WIRE WHICH WAS ADVANCED THROUGH THE INDWELLING DILATOR AND UNDER FLUOROSCOPIC GUIDANCE, THIS WIRE WAS ADVANCED THROUGH THE RIGHT ATRIUM TO THE ATRIAL CAVAL JUNCTION. THE REMAINING DILATOR WAS USED AS WELL AS THE INTRODUCER SHEATH, FOR THE CAPSULE. AT THIS TIME, THE PT'S VITAL SIGNS DETERIORATED AND SUBSEQUENTLY, EPINEPHRINE WAS GIVEN AND CPR BEGUN. THE PT REGAINED SINUS RHYTHM AND THE BLOOD PRESSURE STABILIZED. BECAUSE OF THE PT'S UNSTABLE CONDITION, THE CAPSULE WAS INJECTED AT L, -L2 WITHOUT BENEFIT OF FLUOROSCOPY. THE 9600 C-ARM CIRCUIT BREAKER (CB1 AT THE BOTTOM REAR OF THE WORKSTATION) TRIPPED, THUS SHUTTING DOWN THE MACHINE. UPON RESETTING THE BREAKER, THE MACHINE RE-BOOTED AND WORKED NORMALLY FOR A BRIEF TIME WHEN THE CIRCUIT BREAKER TRIPPED AGAIN. THIS HAPPENED A TOTAL OF THREE TIMES CAUSING ABSENCE OF FLUOROSCOPY FOR A PERIOD OF 5-10 MINS. THE CATHETER SYSTEM WAS WITHDRAWN AND THE PT APPEARED FAIRLY STABLE. HOWEVER, WITHIN 5-10 MINS THE PT BECAME HYPOTENSIVE AND BRADYCARDIC AND REQUIRED CPR. DISCUSSION WITH THE FAMILY REVEALED THEY WANTED EVERYTHING DONE FOR THE PT. THE PT WAS PREPPED FOR AN OPEN THORACOTOMY AND PLACED ON PERCUTANEOUS SUPPORT. DURING MEDIASTINAL EXPLORATION, A TAMPONADE AS WELL AS 1-2 LACERATIONS OF THE FREE WALL OF THE RIGHT VENTRICLE WERE IDENTIFIED. RELEASE OF THE TAMPONADE, REPAIR OF THE RIGHT VENTRICLE LACERATION, PULMONARY ARTERY EXPLORATION, PLACEMENT OF A TRIPLE LUMEN CENTRAL VENOUS CATHETER AND PLACEMENT OF AN ARTERIAL LINE WERE PERFORMED. THE PT WAS TRANSFERRED IN CRITICAL CONDITION TO ICU WHERE SHE WAS MAINTAINED UNTIL THE TIME OF HER DEATH ON 9/21/96.
A PT PRESENTED AT DOCTOR'S OFFICE ON 11/20/95 WITH A FRACTURED SCREW IN THE IMPLANT. THE FRACTURED PORTION WAS IMBEDDED IN THE IMPLANT. PT WAS SENT TO PERIODONTIST TO BE RETRIEVED. THE PERIODONTIST FOUND BONE LOSS AND ELECTED TO GRAFT THE SITE BEFORE REPLACING THE RESTORATION.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE EXHIBITED REDUCED ASPIRATION. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F OF THIS MEDWATCH WAS COMPLETED BY THE MFR. THE DATE USED IN SECTION F.13 IS THE DATE THE REPORT WAS REC'D BY THE MFR. COMPLAINT COULD NOT BE DUPLICATED, HOWEVER, THE HANDPIECE WAS FOUND TO BE DEFECTIVE.
ON 9/20/96, THE MFR RECEIVED INFO IN RESPONSE TO A DEVICE TRACKING POLLING LETTER. THE RESPONSE FROM THE PT STATES THAT THE DEVICE IS NOT BEING USED ANYMORE AND QUESTIONS WHETHER OR NOT IT SHOULD BE REMOVED.
ON 10/1/96, THE MFR RECEIVED COPIES OF THE PHYSICIAN'S NOTES FOR THE PT'S LAST SCHEDULED APPOINTMENT. THE NOTES INDICATE THAT THE PT WAS SEEN ON 3/13/96, POST INFECTED TOTAL HIP WHICH WAS TREATED WITH THE DEVICE. THE DEVICE SITE LOOKED GOOD; HOWEVER, THE PT COMPLAINED OF PAIN AND DISCOMFORT. THE PHYSICIAN NOTED THAT IF THE PT'S HIP IS NOT GETTING BETTER SYMPTOMATICALLY THAT THEY WOULD REMOVE HER PROSTHESIS AND LEAVE THE PUMP AND BEADS IN PLACE. THE NOTES ALSO INDICATE THAT ON 4/19/96, THE PT COMPLAINED OF PAIN IN THE RIGHT LOWER QUADRANT. THE PHYSICIAN'S OFFICE RECOMMENDED THAT THE PT CONTACT HER PRIMARY CARE PHYSICIAN AND IF THE PHYSICIAN WOULD LIKE THE SURGEON TO REMOVE THEPUMP, AN APPOINTMENT WOULD BE SCHEDULED FOR PUMP REMOVAL. AS PART OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MANUFACTURING VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. BASED ON THE INFO AVAILABLE, USE OF THE DEVICE WAS DISCONTINUED DUE TO THE PT'S DECREASE IN THERAPEUTIC RESPONSE AND NOT DUE TO PROBLEMS ASSOCIATED WITH THE FUNCTION OF THE DEVICE. THE DEVICE APPEARS TO HAVE PERFORMED AS INTENDED. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMETN DID NOT FIRE PROPERLY.
9/25/96-MEDWATCH REORT NOT RECEIVE BY MFR. SUBMITTED INITIAL REPORT.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. THE DEVICE WAS INSERTED INTO THE PT CAVITY AND THE CARTRIDGE FELL INTO THE PT. THE CARTRIDGE AND THE INSTRUMENT WERE REMOVED. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
F1: SHOULD NOT HAVE BEEN CHECKED ON INITIAL MEDWATCH. NO MEDWATCH WAS RECEIVED BY USER FACILITY. D5; H4-INFORMATION NOT AVAILABLE. G3: HEALTH PROFESSIONAL WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH. BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE CARTRIDGE REPORTEDLY "FELL OUT OF THE INSTRUMENT" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE CARTRIDGE RETENTION FEATURE WAS MEASURED AND WAS FOUND TO BE CONFORMING TO DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY, CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO PRODUCTS.
PT PRESENTED WITH INFECTED ELBOW. TAKEN TO OR. FILM SHOWED PIVOT PIN WAS BACKING OUT. DR OPENED UP; POLYETHYLENE BEARING SURFACES WERE CRACKED AND BROKEN OFF. SPLIT RING STILL IN PLACE. PIVOT PIN BACKING OUT. TISSUE BLACKENED AROUND IMPLANT. REMOVED THE BROKEN/WORN POLYETHYLENE AND REPLACED WITH NEW SPLIT RING AND PIVOT PIN.
PT SCHEDULED FOR PTCA AND STENT REPLACEMENT. FOUR (4) STENTS PLACED IN RCA AND LCA. ONE (1) STENT WAS LOST IN PT. PT DIED 4 DAYS AFTER STENT PLACEMENT. SUSPECT THROMBOSIS SECONDARY TO STENT BUT CANNOT CONFIRM AS NO AUTOPSY WAS DONE.
DURING A COLON RESECTION PROCEDURE THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON RELOADED THE INSTRUMENT AND IT FIRED SATISFACTORILY. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/27/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
INFO IN SECTIONS A-F WAS RECEIVED ON A MEDWATCH FORM ON 8/29/96. THIS INFO WAS CONFIRMED DURING A TELEPHONE CONVERSATION WITH A PERSON OF THE CARDIAC CATH LAB ON 9/6/96. BASED UPON THE AVAILABLE INFO, THE ROLE OF THE STENTS IN THE PT'S DEATH REMAIN UNCLEAR. PT CODE: 2200(OTHER)-HEMODYNAMICALLY UNSTABLE. ALSO, CO BELIEVES THE "PERUOGERAL" VASCULAR DISEASE LISTED IN SECTION A7 IS IN ACTUALITY "PERIPHERAL" VASCULAR DISEASE.
WHEN REMOVED FROM PACKAGING FOR USE IN A CODE SITUATION, OXYGEN RESERVOIR BAG WAS OBSERVED TO BE DETACHED FROM THE DEVICE. PT WAS SUCCESSFULLY RESUSCITATED USING ANOTHER DEVICE.
DEVICE IS STORED IN A FOLDED CONDITION. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE OXYGEN RESERVOIR BAG HAD BEEN ATTACHED DURING THE MANUFACTURING PROCESS, BUT WAS DISCONNECTED FROM THE DEVICE UPON UNFOLDING THE DEVICE FOR USE. INSTRUCTIONS INCLUDED WITH THE DEVICE HAVE BEEN CLARIFIED TO INDICATE THE PROPER METHOD FOR UNFOLDING THE DEVICE TO PREVENT FUTURE OCCURRENCES. NOTE: NO USER FACILITY REPORT WAS RECEIVED. PART F. WAS COMPLETED BY MFR. STANDARD DISCLAIMER ON FILE.
SURGEON INJECTED BONE CEMENT, WAITED 5 MINS FOR CEMENT TO GET DOUGHY THEN INSERTED A FEMORAL STEM FOR A BIPOLAR HIP ARTHROPLASTY. STEM COULD NOT BE FULLY INSERTED BECAUSE THE CEMENT IN THE DISTAL CANAL HAD ALREADY HARDENED. STEM WAS REMOVED AND CEMENT WAS REMOVED. NEW STEM WAS INSERTED WITHOUT CEMENT. SURGICAL TIME IS USUALLY 60 MINS FOR A BIPOLAR HIP. THIS CASE LASTED 4 HRS.
INITIAL REPORT OF THE MODEL 920 UV-ABSORBING SILICONE LENS THAT CRACKED DURING IMPLANT WAS REC'D FROM A CO SALES REP, OPHTHALMIC DIV. DURING IMPLANT, THE LENS STAYED FOLDED UPON RELEASE FROM THE FORCEP. THE CRACK WAS NOTED AT THE FOLD. AS THE PHYSICIAN BEGAN TO EXPLANT THE LENS, HE CUT THE LENS IN HALF AND DURING REMOVAL, THE HAPTIC BROKE. THE OTHER HALF OF THE LENS WAS REMOVED BY HOLDING THE HAPTIC WHILE PULLING IT OUT. SUBSEQUENTLY, THE HAPTIC JUNCTION TORE THE CAPSULAR BAG. A COMPETITOR LENS WAS IMPLANTED, WHICH ALSO CRACKED AND WAS REMOVED. ANOTHER ABSORBING SILICONE LENS WAS IMPLANTED SUCCESSFULLY. THE LENS WAS RETURNED TO THE MFR FOR EVAL. ADD'L INFO IS BEING SOUGHT FROM THE OPHTHALMOLOGIST.
THE 7MM TIBIAL INSERT WAS REMOVED DUE TO POLY WEAR AND REPLACED WITH A 9MM INSERT.
IN AN ATTEMPT TO CROSS LAD LESION WITH A 3.0 STENT, STENT WOULD NOT CROSS AND DEPLOY, SYSTEM WAS REMOVED, STENT HAD SEPARATED FROM THE BALLOON. STENT WAS LOCATED IN AORTA AND ATTEMPT TO RETRIEVE IT WAS UNSUCCESSFUL.
DISTRIBUTOR WAS INFORMED ON AN EXPLANT REPORT THAT THE MFR'S SENSE PACE LEAD ADAPTER WAS EXPLANTED ON 8/15/96 DUE TO NOISE. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORM TO SPEC.
FACILITY REPORTED THAT 15 MIN BEFORE THE PT WAS SCHEDULED TO COME OFF, BLOOD WAS SEEN ON THE FLOOR UNDER THE PT'S DIALYZER AND IT WAS NOTED THAT THE TOP HEADER OF THE DIALYZER WAS CRACKED ALONG THE SIDE. BLOOD WAS RETURNED, EBL 100-150CC. THERE WAS NO PT INJURY REPORTED. THE SAMPLE WAS DISCARDED BY THE FACILITY.
SECTIONS A-F ARE REPLICATED FROM A MEDWATCH FORM RECEIVED ON 8/29/96. ADD'L INFO PROVIDED BELOW WAS OBTAINED DURING A TELEPHONE CONVERSATION WITH THE CARDIAC CATH LAB SUPERVISOR, ON 9/5/96: ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE CALCIFIED TARGET LESION SITE IN THE PT'S LEFT ANTERIOR DESCENDING ARTERY WERE UNSUCCESSFUL. DURING WITHDRAWAL OF THE DELIVERY SYSTEM, THE STENT DISLODGED FROM THE BALLOON CATHETER. STENT RETRIEVAL ATTEMPTS WITH A SECOND GUIDEWIRE WERE UNSUCCESFUL. THE STENT EMBOLIZED TO THE PERIPHERAL CIRCULATION. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. PT CODE: 2199, 1758. DEVICE CODE: 1179, 1395.
DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
A 22 FR. SILASTIC FOLEY WITH 5CC BALLOON OPENED TO OR FIELD. PLACED IN PT BY DOCTOR DURING A PROSTATECTOMY PROCEDURE. WHILE CLOSING PT IT WAS NOTED FOLEY CAME OUT. UPON REINFLATION, IT WAS NOTED THAT BALLOON HAS A SLOW LEAK OF STERILE FLUID, THEREFORE THAT BALLOON HAS A SLOW LEAK OF STERILE FLUID, THEREFORE DEFLATED. NEW 22 FR. SILASTIC WITH 5CC BALLOON OPENED AND TESTED WITH LEAKS. DUE TO THE PRESENCE OF SUTURES IN THE SWOLLEN BLADDER NECK, IT WAS NOT POSSIBLE TO REINSERT THIS CATHETER THROUGH THE URETHRA AND THE BLADDER NECK. REOPENING OF THE ABDOMINAL WOUND WAS NECESSIATED FOR PLACEMENT OF THIS CATHETER. THE WOUND WAS RECLOSED, AND THERE HAVE BEEN NO FURTHER COMPLICATIONS REPORTED ON THIS PT. REPORTEDLY, THE DOCTOR STATED, "1ST FOLEY TESTED WITHOUT LEAKS".
INVESTIGATION IS IN PROGRESS. REFERENCE MFR COMPLAINT #K96-9-9-54. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
PT IN RESTRAINT IN WHEELCHAIR. PT LEANED FORWARD, VELCRO CAME LOOSE AND THE PT FELL OUT OF THE WHEELCHAIR.
CO IS ATTEMPTING TO LOCATE THE SUBJECT DEVICE AND INSPECT IT. THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY COMPLETENESS OR RELATIONSHIP TO THE PRODUCT. CO IS JUST  RESPONDING TO THIS EVENT AS REQUIRED BY LAWW.
DURING A CATARACT EXTRACTION PROCEDURE, THIS BIPOLAR ADAPTER COULD NOT BE USED. ANOTHER ADAPTER OR GENERATOR WAS USED TO COMPLETE THE PROCEDURE. THREE ADAPTERS ARE BEING RETURNED FOR EVAL.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS REC'D. THREE ADAPTERS WERE RETURNED. NO PROBLEM WAS FOUND WITH TWO ADAPTERS.
FACILITY REPORTED THAT AT 8:30 WHILE THE PT WAS DIALYZING IT WAS NOTED THAT THE DIALYSATE DRAIN OF THE PT'S MACHINE WAS CHERRY IN COLOR. THE PT'S TREATMENT WAS STOPPED AND NO BLOOD WAS RETURNED. BLOOD WAS ALSO NOTED IN THE DIALYSATE PORTS. THE PT WAS SYMPTOMATIC OF POSSIBLE HEMOLYSIS WITH SOB, N&V AND DIAPHORESIS. THE FACILITY STATED THAT THE MACHINE FAILED TO ALARM BLOOD LEAK. THE PT WAS SENT TO THE HOSP AND RECEIVED 6 BLOOD TRANSFUSIONS. THE MACHINE WAS PULLED FROM THE FLOOR AND A CO SVC REP CAME AND REPLACED THE DEFECTIVE BLOOD LEAK DETECTOR.
PT HAD CENTRAL VENOUS CATHETER WHICH HAD CLOTTED OFF AND NEEDED TO BE REMOVED. WHEN PHYSICIAN ATTEMPTED TO REMOVE CATHETER, THE CATHETER BROKE INTO TWO PIECES. ONE PIECE OF CATHETER REMAINED IN THE PT AND MIGRATED TO THE HEART. A CARDIAC CATHERIZATION WAS PERFORMED TO LOCATE AND RETRIEVE THE BROKEN PIECE OF CATHETER WHICH MEASURED APPROX. 7 CENTIMETERS.
EXAMINATION OF THE BROKEN EDGES OF THE CATHETER SHOW THEM TO BE SEMI-GLOS-AND FLAT WITH SOME STRIATIONS SEEN ON THE SURFACE. THE FRAGMENTS ARE BROKEN AT AN ANGLE AND THESE APPEAR TO MATCH UP. THESE SIGNS INDICATE THAT THE CATHETER WAS CUT AND NOT BROKEN, POSSIBLE BY A METAL INSTRUMENT SUCH AS SCISSORS.
DURING A COLON RESECTION PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON COMPLETED THE PROCEDURE BY MANUAL SUTURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/26/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
THE PLATE DEVELOPED A LEAK 1 HR 20 MIN INTO THE RUN. EBL >100CC. THERE WAS NO PT INJURY REPORTED.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT REMOVAL. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
DURING A DIALYSIS TREATMENT, NO WEIGHT LOSS WAS REPORTED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REPORTED. A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND THE UF PUMP WAS REPLACED AS A PRECAUTION WHEN THE PROBLEM RECURRED. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT TWO OTHER INCIDENTS RESULTED FROM THE COMPONENT FAILURE INVESTIGATED IN THIS COMPLAINT. THE FIRST COMPLAINT OCCURRED WHEN THE PUMP FAILED BUT THE FIELD REP COULD FIND NO PROBLEM AND DID NOT RETURN A PART. THE NEXT TWO COMPLAINTS WERE GENERATED WHEN TWO PTS EXPERIENCED WEIGHT REMOVAL PROBLEMS AND THE UF PUMP WAS REPLACED. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT SHOWED NO RELATED DTF'S. THE TECHNICIAN AT THE FACILITY FOUND THE UF (ULTRAFILTRATION) PUMP TO BE FAULTY. THE RETURNED UF PUMP WAS RECEIVED FOR ANALYSIS BY THE MFR ON 9/13/96. THE THERMAL FUSE WAS REMOVED FROM THE RETURNED UF PUMP. THE THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE OHM METER SHOWED 0.2 OHMS, INDICATING THE THERMAL FUSE IS GOOD. THE THERMAL FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. CUSTOMER CONTACTED:N SALES/SERVICE CONTACTED BY INVESTIGATOR:N. TRAINING REQUIRED:N.
DURING A CARPAL TUNNEL PROCEDURE, THIS PAIR OF SCISSORS BROKE AT THE SCREW INTO TWO PIECES. ANOTHER PAIR OF SCISSORS WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS REC'D. THE SCISSORS APPEARED TO HAVE BEEN USED ON HEAVY MATERIAL AND THE BLADES OF THIS DEVICE WAS FOUND TO BE CHIPPED.
INVESTIGATION CONDUCTED. CAUSED FOR FAILURE IS UNK. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
ON 7/24/96 CATHETER WAS PLACED IN THE LEFT FEMORAL VEIN. DURING REVIEW OF A ROUTINE ABDOMINAL X-RAY FILM, A BREAK WAS NOTED IN THE LINE. ON 8/19/96 THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR SURGICAL REMOVAL AND REPLACEMENT OF THE DEVICE.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, THE STAPLER DID NOT FORM PROPERLY. THE SURGEON COMPLETED THE PROCEDURE BY MANUALLY SUTURING. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/26/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INTIAL REPORT.
THE DEVICE WAS NOT RETURNED FOR EVALUATION, DESPITE FOUR ATTEMPTS TO CONTACT THE FACILITY TO ASK FOR RETURN OF THE PRODUCT.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT HOLD. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/26/96-MEDWATCH REORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
LASER ENERGY BURNT THROUGH FIBER NEAR BOOT/PROXIMAL CONNECTOR. REPORTER STATED THAT PHYSICIAN HAD COMPLETED FIRST LEVEL AND MOST OF NEXT LEVEL ON AN ENDOSCOPIC LUMBAR DISCECTOMY PROCEDURE, WHEN SCRUB TECHNICIAN HEARD A "POP" AND LOOKED AT FIBER TO LASER CONNECTION AT WHICH TIME HE NOTED TWO RAYS OF "LIGHT" EXITING FIBER NEAR BOOT ONE AT APPROX 10:30 AND ONE AT APPROX 4.00 (IF YOU WERE LOOKING AT A CLOCK). LASER WAS IMMEDIATELY SHUT DOWN AND DISCONTINUED USE OF THE FIBER. REPORTER STATED THAT THE INCIDENT OCCURRED AND THAT NO ONE HAD BENT THE TIME THAT NO ONE WAS NEAR THE LASER AT THE TIME THAT THE INCIDENT OCCURRED AND THAT NO ONE HAD BENT FIBER AND OR LEANED UP AGAINST IT. NO INJURIES WERE REPORTED. NOTE: VISUAL INSPECTION (BY REPORTER) SHOWS A VISIBLE HOLE IN THE BOOT (STRAIN RELIEF) OF DEVICE.
NOTE ALL OF THE INFO ON THIS FORM HAS BEEN COMPLETED BY CO MFR. THE APPLICABLE CODES FOR SECTION F10 ARE AS FOLLOWS. PT CODE: 2199. DEVICE CODE: 1219. CODE 1738 LABELED. EXPLANTATION FOR CODE 68 FOR SECTION H6 CONCLUSIONS: DEVICE FAILURE RELATED TO HANDLING.
DURING LAPAROSCOPIC TUBAL BANDING, SURGEON TRANSECTED LEFT FALLOPIAN TUBE WHILE TRYING TO APPLY THE BAND ONTO THE TUBE. MINI-LAPAROTOMY DONE TO RESECT THE TUBE AND LIGATE THE ENDS.
THE DEVICE WAS USED DURING A THORACOSCOPY. THE DEVICE STAPLE LINE, ON THIRD FIRING, WAS NOT HEMOSTATIC. IT WAS OBSERVED ONE SIDE OF CARTRIDGE DRIVERS HAD NOT FULLY ADVANCED, INDICATING MALFORMED STAPLES. THE SURGEON GRASPED THE BLEEDING TISSUE AND HEMOSTASIS WAS ACHIEVED WITH SUTURE. PROCEDURE CONTINUED WITH FOUR MORE RELOADS IN SAME DEVICE. CARTRIDGE ZR45B, LOT #J4217M WAS NOT SAVED. BUTTRESSING MATERIAL WAS NOT USED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4 CONTACTED SURGEON AND RISK MGR. INFO NOT AVAILABLE. B6,7 CONTACTED SURGEON AND RISK MGR. INFO NOT AVAILABLE. D10 CONTACTED SURGEIN AND RISK MGR. INFO NOT AVAILABLE. D5;F;H4 DEVICE DISCARDED. INFO UNK. 7/29/96 1245 LEFT MSG AND 800 NUMBER WITH PERSON AT SURGEON'S OFFICE. 7/30/96 1500 NNCL SENT. 8/7/96 SPOKE TO RISK MGMT. SHE IS ATTEMPTING TO OBTAIN ADD'L INFO TO COMPLETE MED WATCH FORM. H3 NO ANALYSIS COULD BE PERFORMED SINCE NO INSTRUMENT WAS RETURNED. NO CONCLUSION COULD BE REACHED AS TO WHY THIS INCIDENT OCCURRED.
FACILITY REPORTED THAT 5 MINS AFTER THE START OF HEMODIALYSIS TREATMENT THE PT EXPERIENCED SWELLING OF THE EYELIDS, LIPS AND HAD LARYNGEAL EDEMA. THE PT WAS GIVEN SOLU-CORTEF 100MG IV AS ORDERED BY THE DR. THE PT'S BLOOD WAS NOT RETURNED. THE PT VOICED THAT SHE DID NOT FEEL ANY CHANGE. HER THROAT REMAINED TIGHT BUT SHE WAS NOT IN ANY RESPIRATORY DISTRESS. THE PT WAS THEN GIVEN SOLU-MEDROL 125MG IV AND THEN BENADRYL 25 MG IV. THE PT STATED THAT SHE FELT BETTER. THE PT'S TREATMENT WAS STOPPED AND HER BLOOD WAS RETURNED. THE PT WAS DISCHARGED HOME WITH INSTRUCTIONS TO CALL THE CLINIC IF THE SYMPTOMS REOCCUR. THE PT STATED PRIOR TO BEING DISCHARGED THAT SHE HAD EATEN UNWASHED GRAPES. THE UNIT BELIEVES THAT THE PT HAD EITHER A DIALYZER REACTION, INSECTICIDE REACTION OR A REACTION TO HAPTEN.
DURING A LAPAROSCOPIC TUBAL STERILIZAION, THE LEFT FALLOPIAN TUBE WAS TRANSECTED WHILE TRYING TO APPLY THE BAND ONTO THE TUBE. A MINI-LAPAROTOMY WAS PERFORMED TO RESECT THE TUBE AND LIGATE THE ENDS.
INTERNAL REFERENCE NO. 15866. NO. OF PERSONS 1. LABELING FOR THE BAND, WHICH IS USED WITH THE BAND APPLICATOR, IDENTIFIES INSTANCES WHEN ADD'L SURGERY  MAY BE REQUIRED. SEE THE FALOPE-RING BAND MANUAL. ACCORDING TO THE RISK MANAGER, THE PT WAS AN OUTPT AND THE WEIGHT WAS NOT NOTED.
INCIDENT WITH PEDIATRIC PT IN WHICH LINES ON DEVICE "CLAMPED OFF". WHEN UNCLAMPED, ONE OF THE LINES SPLIT. DUE TO A DROP IN LINE PRESSURE, BLOOD STARTED TO RUN UP THE LINE AND THEN OUT OF IT. NURSE REMOVED LINE (EXTENSION SET) TO STOP FURTHER BLEEDING. "NO DETRIMENTAL AFFECT OF PT REPORTED DUE TO ATTENDANCE OF MEDICAL STAFF". DEVICE CONNECTED TO CENTRAL LINE.
EVAL SUMMARY: ACTUAL DEVICE WAS 'HEAVILY CONTAMINATED' AND WAS NOT RETURNED FOR EVAL. TWO UNUSED SAMPLES OF THE SAME LOT WERE RETURNED AND TESTED PER SPECIFICATIONS AND NO ABERRANCIES WERE NOTED. THE SLIDE CLAMPS ON EACH LEAD OF TUBING WERE CLOSED AND PRESSURE TESTED WITH 45 PSI OF WATER AND NO LEAKS WERE DETECTED. THE SLIDE CLAMPS WERE THEN OPENED AND CLOSED FOR A TOTAL OF 24 CYCLES AND AFTER EVERY 6TH CYCLE PRESSURE TESTED WITH WATER AT 45 PSI AND NO LEAKS WERE DETECTED. ON THE 24TH CYCLE THE SLIDE CLAMPS WERE LEFT IN THE CLOSED POSITION FOR 24 HOURS AND THEN SUBJECTED TO A 45 PSI WATER PRESSURE TEST AND NO LEAKS WERE DETECTED.
FACILITY STARTED TO USE THE VENTILATOR ON PT, BUT COULD NOT VENTILATE PT. TRIED OTHER PT CIRCUITS FROM THE SAME LOT, BUT NONE OF THE CIRCUITS WOULD WORK IN THE PERFORMANCE TEST OF THE VENTILATOR.
PER THE INFO PROVIDED TO CO THROUGH MEANS OF THE PHYSICIAN'S/SURGEON'S OPERATIVE NOTES, THE DEVICE WAS REMOVED DUE TO "BREAKGE OF THE TUBING FROM THE PUMP TO BOTH CYLINDERS WAS NOTED AT THE LEVEL OF THE PUMP PLATFORM". THE PUMP AND ASSEMBLY KIT COMPONENTS ONLY WERE REMOVED AND REPLACED, "THREE STRAIGHT CONNECTORS WERE THEN USED TO ATTACH THE RESERVOIR AND TWO CYLINDERS TO A NEW PUMP". ADDITIONALLY, IT WAS NOTED THAT THE PT UNDERWENT A TRANSURETHRAL RESECTION OF THE PROSTATE, CONCURRENTLY WITH THE REVISION OF HIS PENILE PROSTHESIS.
EVAL IS PENDING DECONTAMINATION, EXAM AND TESTING OF THE RETURNED DEVICE COMPONENTS. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELLING OR USUAL FOR DEVICE. AN EVALUATION WILL BE FORWARDED UPON COMPLETION.
THE CANNULA SNAPPED WHILE BEING MANIPULATED INTO THE RIGHT ATRIUM.
ALL UNK INFO REQUESTED NOT RECEIVED. SECTION F PROVIDED BY MANUFACTURER. SECTION F10 DEVICE CODE 1339 NOT LABELED. INTERNAL # 061996090014.
PT WAS IN A BED IN CARDIO SURGICAL UNIT. ONE OF THE CUSHIONS DEFLATED. THE CUSHION DEFLATION DID NOT TRIGGER THE BED ALARM. PT WAS PUT ON THE BED WITH A GRADE 1 DECUBITUS, WHEN THE CUSHION DEFLATED IT BECAME A GRADE 2. PT DEVELOPED A LARGE DECUBITUS.
THE STAPLER WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. THE SURGEON TRANSECTED THE ROUND LIGAMENT. THE STAPLER WAS FIRED AND 3 ROWS OF STAPLES WERE NOTED WITH EACH STAPLE LINE. THE SURGEON CUT BETWEEN THE STAPLE LINES. THE AREA WAS OBSERVED TO BE HEMOSTATIC. APPROX 30 MINUTES LATER THE SURGEON OBSERVED BLEEDING ALONG THE STAPLE LINE OF THE LEFT OVARIA LIGAMENT. A BOVIE WAS USED TO COAGULATE THE BLEEDING. THE DEVICE WAS FROM A TRAY, LOT# J42N11. REP WILL BE RETURNING 6 RELOADS DUE TO NOT KNOWING WHICH FIRING THE BLEEDING OCCURRED WITH. THERE WAS NO CONSEQUENCE TO THE PT.
CODE 400=NICKED KNIFE). CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED WITH A NICKED KNIFE, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, AND FORMED THE STAPLES WITHIN DESIGN SPEC, BUT HAD A ROUGH CUT DUE TO THE NICKED KNIFE. NO CONCLUSION COULD BE REACHED AS TO HOW THE KNIFE HAD BECOME DAMAGED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
A 6 FR. SHEATH SEPARATED WHEN INSERTED INTO PT. IT WAS REMOVED WITH A WIRE.
LIGHT SOURCE TURNED ON IN OR WHICH HUNG OVER DRAPE AND IMMEDIATELY SMOKE DEVELOPED AND A BURN WAS NOTED ON THE DRAPE. NO INJURY OCCURRED TO PT OR STAFF, HOWEVER, POTENTIAL WAS HIGH DUE TO FLAME.
LEADS WERE REMOVED DUE TO LEAD FRACTURE. DURING A REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE LEADS WERE CAPPED AND REPLACED WITH A BIPOLAR LEAD.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON LOW IMPEDANCE. NO FUTHER INFO IS AVAILABLE.
BOTH FALLOPIAN TUBES WERE TRANSECTED DURING A LAPAROSCOPIC TUBAL STERILIZATION USING THE BAND APPLICATOR SYSTEM. THE SURGEON THEN PERFORMED A MINI-LAPAROTOMY TO RESECT THE TUBES AND THEN LIGATED BOTH TUBES.
INTERNAL REFERENCE NO. 15865. NO. OF PERSONS 1. LABELING FOR THE FALOPE-RING BAND, WHICH IS USED WITH THE FALOPE-RING BAND APPLICATOR, IDENTIFIES INSTANCES WHEN ADD'L SURGERY MAY BE REQUIRED. SEE THE FALOPE-RING BAND MANUAL. ACCORDING TO THE RISK MANAGER, THE PT WAS AN OUTPT AND THE WEIGHT WAS NOT NOTED.
REVISION SURGERY DONE DUE TO A FRACTURED CERAMIC FEMORAL HEAD (HIP REPLACEMENT). THE PT HAD NO COMPLICATIONS FROM THE PROCEDURE. THE FEMORAL HEAD AND ACETABULAR LINER WERE SENT TO AN INDEPENDENT LAB FOR ANALYSIS.
THE VACUUM TUBE WAS SEPARATED FROM THE BACTERIAL AIR FILTER. THIS INCIDENT WAS FOUND DURING PRETEST.
DURING A GASTRIC EXCLUSION THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
RUPTURE OF PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DURING DEPLOYMENT WITH DETACHMENT OF DISTAL HALF OF BALLOON WITHIN PT REQUIRING AORTAL FEMORAL BYPASS GRAFT.
THE DEVICE WAS USED DURING A LAPROSCOPIC BILATERAL HERNIA REPAIR. THE SURGEON USED THREE EAS STAPLERS AND TWO EMS STAPLERS TO COMPLETE A SLIDING BILATERAL LAP HERNIA IN A THIN FEMALE PT. FOUR OF THE STAPLERS WORKED WELL, BUT ONE FELL APART IN THE PT AFTER A COUPLE FIRINGS. THE BLADDER WAS KNICKED, IN WHAT MANNER IS NOT KNOWN AT THIS TIME. THE REP WILL COLLECT MORE INFO. 08/02/1996-SURGEON REPORTED THE BLADDER KNICK HAD NO RELATION TO THE DEVICE.
UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
LOSS OF ATRIAL SENSING AND CAPTURE WAS OBSERVED.
PT WAS CLEANING TRACHEOSTOMY TUBE WITH IT IN PLACE AND THE STEM ON THE CLEANING BRUSH BROKE LEAVING THE BRUSH STUCK IN THE TRACH TUBE. PT CAME TO THE HOSP ER WHERE BRUSH WAS REMOVED FROM THE TRACH TUBE WITHOUT ANY ADVERSE OUTCOME.
DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE PACEMAKER LEAD INDICATED INTERMITTENT LOSS OF CAPTURE AFTER FIVE DAYS OF IMPLANTATION.
THE DC RESISTANCE PIN TO TIP AND PIN TO RING RESPECTIVELY ARE WITHIN THE ELECTRICAL SPECIFICATIONS. THE COMPLEX IMPEDANCE AS A FUNCTION OF THE SIGNAL FREQUENCY IS WITHIN SPECIFICATION FOR BOTH TIP AND PIN RESPECTIVELY. THE LEAD SHOWS A SLIGHT DEFORMATION, PROBABLY DUE TO HANDLING WHICH, HOWEVER, IS NOT INFRINGING THE FUNCTIONALITY OF THE DEVICE. THIS LEAD IS NOT DEFECTIVE.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE. AS THE GUIDE WIRE AND BALLOON CATHETER WERE PULLED BACK, THE BALLOON DEFLATED. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED A CIRCUMFERENTIAL TEAR OF THE BALLOON MATERIAL. THE DISTAL SECTION OF THE BALLOON WAS BUNCHED UP TOWARD THE DISTAL BOND. THE CORE WIRE, SPRING TIP, AND BALLOON BONDS REMAINED INTACT. THE CAUSE OF THE BALLOON DAMAGE COULD NOT BE DETERMINED.
DURING A HERNIA REPAIR PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
PT WAS FOUND WITHOUT PULSE AND WITHOUT RESPIRATIONS - FULL CARDIOPULMONARY ARREST - AND CPR WAS INITIATED. THE MANUAL RESUSCITATOR WAS OBTAINED FROM THE CODE CART AND THE MASK WAS MISSING. THE MANUAL RESUSCITATOR COMES AS A SINGLE USE FROM THE CO AND IS PREPACKAGED. THE BLUE SEAL ON THE STRINGS OF THE BAG WERE PRESENT AND HAD TO BE BROKEN TO OPEN THE BAG. THEREFORE IT CAME FROM THE CO WITH THE MASK MISSING. THIS DELAYED RESPIRATORY RESUSCITATION.
A PT WAS CAUGHT ON FIRE AT A PARKING METER NEXT TO A PARKING LOT (USING SYSTEM)." IT WAS INITIALLY REPORTED THAT THE PT RECEIVED SECOND AND THIRD DEGREE BURNS ON HER BACK AND ARMS. THE FIRE MARSHALL'S REPORT STATED THAT "THE PT HAD GOTTEN OUT OF HER CAR AND WAS WALKING TO THE PARKING METER. SHE WAS GOING TO PUT SOME COINS IN THE PARKING METER WHEN ALL OF A SUDDEN HER BLOUSE AND THE OXYGEN TANK UNIT THAT SHE WAS WEARING JUST BURST INTO FLAMES." THE FIRE MARSHALL ALSO STATED "THAT THEY  USED A DRY PODWER FIRE EXTINGUISHER TO EXTINGUISH THE BURNT CLOTHING THAT HAD TAKEN OFF AND THE OXYGEN TANK SHE WAS WEARING." PRELIMINARY INVESTIGATION BY THE FIRE MARSHALL AND THE CRIME LAB REVEALED THE DEVICE WAS FUNCTIONAL AT THE TIME OF THE INVESTIGATION. THE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. THE SYSTEM IS BEING HELD PENDING LITIGATION AND IS CURRENTLY UNAVAILABLE FOR INVESTIGATION. UPON COMPLETING THE LITIGATION THE UNIT WILL BE RELEASED TO THE MFR OR DISTRIBUTOR FOR FURTHER EVALUATION AND INVESTIGATION.
H-6: 86 - DEVICE NOT RETURNED TO MFR. CO IS A COMPONENT MFG ONLY FOR THE MINI SYSTEM. CO SUPPLIED TO DISTRIBUTOR THE FR-870M REGULATOR AND OL-150 OXYGEN CYLINDER. DISTRIBUTOR ASSEMBLES THE CO PROVIDED PARTS ALONG WITH THE OTHER COMPONENTS TO CREATE THE SYSTEM. THE END USER OR DEALER ATTACHES THE REGULATOR TO THE CYLINDER. DISTRIBUTOR DOES NOT. AS PROVIDED IN 21 CFR 803.16, THIS REPORT DOES NOT REFLECT A CONCLUSION BY CO, OR BY FDA THAT THE REPORT OR INFO CONTAINED THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE OR CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. B.5 " A PT WAS CAUGHT ON FIRE AT A PARKING METER NEXT TO A PARKING LOT (USING SYSTEM)". IT WAS INITIALLY REPORTED THAT THE PT RECEIVED SECOND AND THIRD DEGREE BURNS ON HER BACK AND ARMS. THE FIRE MARSHALL'S REPORT STATED THAT " THE PT HAD GOTTEN OUT OF HER CAR AND WAS WALKING TO THE PARKING METER. SHE WAS GOING TO PUT SOME COINS IN THE PARKING METER WHEN ALL OF A SUDDEN HER BLOUSE AND THE OXYGEN TANK UNIT THAT SHE WAS WEARING JUST BURST INTO FLAMES". THE FIRE MARSHALL ALSO STATED " THAT THEY USED A DRY POWDER FIRE EXTINGUISHER TO EXTINQUISH THE BURNT CLOTHING THAT HAD TAKEN OFF AND THE OXYGEN TANK SHE WAS WEARING". PRELIMINARY INVESTIGATION BY THE FIRE MARSHALL AND THE CRIME LAB REVEALED THE DEVICE WAS FUNCTIONAL AT THE TIME OF THE INVESTIGATION (SEE ATTACHEMENT I). THE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. THE SYSTEM IS BEING HELD PENDING LITIGATION AND IS CURRENTLY UNAVAILABLE FOR INVESTIGATION. UPON COMPLETING THE LITIGATION THE UNIT WILL BE RELEASED TO THE MFR OR DISTRIBUTOR FOR FURTHER EVALUATION AND INVESTIGATION. PRELIMINARY INVESTIGATION BY THE FIRE MARSHALL AND THE CRIME LAB REVEALED THAT THE DEVICE WAS FUNCTIONAL AT THE TIME OF THE INVESTIGATION. THE SYSTEM IS BEING HELD PENDING LITIGATION AND IS CURRENTLY UNAVAILABLE FOR INVESTIGATION BY THE DISTRIBUTOR AND THE MFR. THE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. THE PRELIMINARY FIRE MARSHALL REPORT IS ATTACHED. SHOULD THE SYSTEM BE RETURNED, AN EVALUATION WILL BE PERFORMED AND THE RESULTS WILL BE SUBMITTED IN AN ADD'L INFO REPORT. REFERENCE REPORT 2024040 1996.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE. AS THE GUIDE WIRE AND THE CATHETER WERE PULLED BACK, THE BALLOON DEFLATED. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS CONFIRMED THE DEFLATION DIFFICULTIES. A LEAK IN THE POLYMIDE INFLATION LUMEN WAS NOTED. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED. THE SHAFT MAY HAVE CONTRIBUTED TO THE DEFLATION DIFFICULTIES.
ATTEMPTED A HEART CATHERIZATION UTILIZING THE RIGHT SUPERFICIAL FEMORAL ARTERY. AN ARTERIOGRAPHY WAS PERFORMED FOR AN ABDOMINAL AORTOGRAM WHICH SHOWED A FOREIGN BODY IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THIS WAS REMOVED AND IT WAS DETERMINED THE FRAGMENT WAS PART OF THE CATHETER'S GUIDEWIRE COATING.
EMERGENCY ROOM PERSONNEL WERE ATTENDING TO A PT IN FULL CARDIAC ARREST. THE PT WAS BEING MONITORED USING DISPOSABLE DEFIBRILLATION/ECG ELECTRODES AND REPORTEDLY AFTER BEING SHOCKED, THE MONITOR INTERMITTENTLY DISPLAYED A FLATLINE WITH SOME ARTIFACT. THE OPERATOR SWITCHED TO STANDARD MONITORING ELECTRODES AND CONTINUED TREATMENT TO THE PT. THE PT WAS SUCCESSFULLY COUNTERSHOCKED HOWEVER WAS NOT RESUSCITATED. THE REPORTER STATED THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THIS OPINION WAS BASED ON THE REPORTER'S ASSESSMENT OF THE PT'S VIABILITY AND THE ABILITY TO MONITOR THE PT IN ANOTHER LEAD.
BOTH THE HOSPITAL'S CLINICAL ENGINEERING DEPT AND CO EXAMINED THE DEVICE AND OBSERVED PROPER OPERATION. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA.
DURING A GASTRECTOMY PROCEDURE, THE KNOT DID NOT HOLD. THE HOSP HAS REPORTED NO FURTHER INFO.
IT WAS REPORTED THAT 3 STENTS WERE PLACED IN THE PT'S PROXIMAL MID LEFT CIRCUMFLEX ARTERY. AFTER THE PROCEDURE WAS COMPLETED, THE PT'S BLOOD PRESSURE BEGAN TO DECLINE. IT WAS NOTED UNDER FLUOROSCOPY THAT THE TIP OF THE GUIDEWIRE WAS FLOATING IN THE PERICARDIUM. THE PT EXPERIENCED CARDIAC TAMPONADE AND WAS SENT TO SURGERY. PERICARDIAL WINDOW TECHNIQUE WAS PERFORMED IN SURGERY TO SUCCESSFULLY RETRIEVE GUIDEWIRE FRAGMENT AND TO TACK UP THE PERFORATION. THE PT IS REPORTED AS FINE. THE DEVICE IS BEING HELD BY THE RISK MANAGEMENT DEPT AND IS NOT EXPECTED TO BE RETURNED.
SECTION F WAS PROVIDED BY THE USER FACILITY.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE. A SYRINGE WAS USED TO DEFLATE THE BALLOON. NO PT INJURIES OR COMPLICAITONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED RESIDUAL DRIED CONTRAST MEDIA THROUGHOUT THE BALLOON SHAFT. DUE TO THE CONDITION OF THE SHAFT, TESTING RELATIVE TO THE REPORTED DEFLATION DIFFICULTIES COULD NOT BE PERFORMED. ANALYSIS ALSO REVEALED A KINK IN THE DISTAL PORTION OF THE SHAFT. THE SHAFT KINK MAY HAVE RESTRICTED FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED. NO MATERIAL OR MFG DEFICIENCIES WERE NOTED.
PIN COLLECT IS SCORING THE PINS, ONE PIN BROKE OFF DURING SURGERY.
PLEASE NOTE THAT ALL INFO IN SECTIONS A, B ,D, E, AND F WERE NOT PROVIDED INITIALLY BY THE USER FACILITY AND MFR IS PROVIDING THIS INFO BASED ON CASE INVESTIGATION. ANY INFO NOT PROVIDED IS UNKNOWN OR UNAVAILABLE TO THE USER FACILITY. WHERE DATES ARE SHOWN AS "00/00/0000", THE DATE IS UNKNOWN EXCEPT IN SECTIONS B2,D5,D7,D8,D11 AND D13 WHERE THE DATE IS NOT APPLICABLE (NA). ALSO, CO HAS A NEW DISCLAIMER STATEMENT, PRINTED BELOW, THAT IS EFFECTIVE AS OF THIS DATE. "SUBMISSION OF INFO BY STRYKER UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT".
PT UNDERWENT A LAPAROSCOPIC APPENDECTOMY IN WHICH AN ENDOSCOPIC LINEAR CUTTER WAS USED. IT WAS NOTED, POST PROCEDURE, A LARGE AMOUNT OF RED DRAINAGE FROM THE SURGICAL SITE. THE PT WAS RETURNED TO SURGERY AND WAS FOUND TO BE BLEEDING A SLOW PERSISTENT STREAM FROM THE STAPLE LINE. A CLAMP AND A ENDOLOOP WAS USED TO STOP THE BLEEDING. PT WAS THEN RETURNED TO THE RECOVERY ROOM.
EMT'S ATTENDED TO A PT THAT HAD BEEN DOWN FOR APPROX. 20 MINUTES DESCRIBED AS DIAPHORETIC, PULSELESS AND NOT BREATHING. THE PT WAS CONNECTED TO THE AUTOMATIC EXTERNAL DEFIBRILLATOR(AED) USING DIPOSABLE ECG/DEFIBRILLATION ELECTRODES. REPORTEDLY THE EMT'S EXPERIENCED DIFFICULTY MAINTAINING ELECTRODE ADHERENCE TO THE PT DUE DIAPHORESIS, HOWEVER, THE PT WAS ANALYZED AND THE AED ADVISED THAT NO SHOCK BE DELIVERED. CPR WAS INITIATED AND SHORTLY AFTERWARD A PULSE WAS REPORTEDLY FELT ON THE PT'S NECK. REPORTEDLY, EMT'S OBSERVED AN ASYSTOLE LIKE HEART RHYTHM ON THE AED DISPLAY BUT FELT THEY SHOULD HAVE SEEN A DIFFERENT RHYTHM BASED UPON THE EARLIER DETECTED PULSE. CPR AND OTHER RESUSCITATION THERAPY WAS CONTINUED. THE PT WAS TRANSPORTED AND SUBSEQUENTLY REVIVED AT THE HOSPITAL.
CO EVALUATED THE UNIT AND FOUND IT TO OPERATE NORMALLY DURING PERFORMANCE AND FUNCTIONAL TESTING. AN EVENT TAPE LOGGING ECG AND AUDIO INFO WAS RETURNED AND EVALUATED BY CO. AFTER EVALUATING THE TAPE, CO FOUND THE UNIT HAD OPERATED AS DESIGNED DURING THE EVENT.
DURING A GASTRECTOMY PROCEDURE. THE KNOT DID NOT HOLD. THE HOSP HAS REPORTED  NO FURTHER INFO.
NEURO MONITOR MICRO SENSOR CATHETER WAS INSERTED AT THE TIME OF CRANIOTOMY FOR AN ANEURYSM CLIPPING. DOS= 9/3/96. CATHETER WAS REMOVED ON 9/5/96. AT THE TIME OF REMOVAL A SMALL PORTION OF THE PLASTIC COVER OVER THE WIRE BROKE OFF AND REMAINED IN THE PT'S HEAD. IT COULD NOT BE LOCATED BY X-RAY OR PROBING.
IT HAS BEEN REPORTED TO CO THAT DURING THE PROCEDURE THE CONNECTOR SITE TO THE PUMP LEAKED. REPORTEDLY, THE CONNECTION SEEMED LOOSE. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
DURING A PTCA PROCEDURE, THE BALLOON WAS INFLATED TO 20 ATM (RBP=14 ATM) AND WOULD NOT DEFLATE. A SYRINGE WAS USED TO DEFLATE THE BALLOON ENOUGH TO REMOVE. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED RESIDUAL DRIED CONTRAST MEDIA THROUGHOUT THE SHAFT OF THE CATHETER. DUE TO THE CONDITION OF THE SHAFT, TESTING RELATIVE TO THE REPORTED DEFLATION DIFFICULTIES COULD NOT BE DETERMINED. NO KINKS OR LEAKS WERE NOTED. NO MATERIAL OR MFG DEFICIENCIES WERE NOTED.
DURING AN ANKLE PROSTHESIS IMPLANT THE SUTURE KNOT WAS LOOSE. THE HOSP HAS REPORTED NO PT INJURY
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE.
RETURNED PRODUCT ANALYSIS REVEALED RESIDUAL DRIED CONTRAST MEDIA AND BLOOD THROUGHOUT THE CATHETER SHAFT. DUE TO THE CONDITION OF THE SHAFT, TESTING RELATIVE TO THE REPORTED DEFLATION DIFFICULTIES COULD NOT BE PERFORMED. NO KINKS OR CATHETER DAMAGE WERE OBSERVED. THE CAUSE OF THE DEFLATION DIFFICULTIES COULD NOT BE DETERMINED. NO MATERIAL OR MFG DEFICIENCIES WERE NOTED.
THE PRODUCT WAS APPLIED DURING AN UNSPECIFIED PLASTIC SURGERY PROCEDURE INVOLVING ONE PT. REPORTEDLY, THE SUTURE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
LASER CONTINUED TO LASE AFTER REMOVING FOOT FROM FOOT PEDAL. REPORTER STATED THAT SOMETIME INTO A SHOULDER ARTHROSCOPY THE PHYSICIAN REMOVED HIS FOOT FROM THE FOOT PEDAL AND THE LASER TECHNICIAN AND PHYSICIAN NOTED THAT THE LASER CONTINUED TO LASE. THE LASER TECHNICIAN IMMEDIATELY DEPRESSED THE EMERGENCY SHUT OFF BUTTON, THEN RE-STARTED THE LASER AND IT WORKED FINE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO INJURIES TO STAFF OR PT WERE REPORTED.
THE FIELD SERVICE ENGINEER CONCLUDED THAT THE FOOTSWITCH HAD MECHANICALLY STUCK IN THE "ON" POSITION. FURTHER EVALUATION OF THE FOOTSWITCH REVEALED THAT THE TENSION ON THE LEVER FELT LESS THAN NORMAL. IT WAS ALSO NOTED THAT THE LEVER HINGE PIN APPEARED TO BE PROTRUDING OUT OF THE HOUSING APPROXIMATELY 1/8 INCH, WHICH IS NOT NORMAL. DURING EVALUATION OF THE FOOTSWITCH, THE FIELD SERVICE ENGINEER IDENTIFIED OTHER UNRELATED LASER COMPONENTS THAT REQUIRED SERVICE AND THE LASER AND FOOTSWITCH WERE RETURNED TO CO. UPON RECEIPT OF THE LASER AND FOOTSWITCH, THE LASER WAS REPAIRED AND THEN TESTED WITH THE REPORTED FOOTSWITCH. THE EVENT DID NOT RECUR. A FOOTSWITCH KNOWN TO FUNCTION PROPERLY WAS ADJUSTED MANUALLY TO RECREATE THE LEVER HINGE PROTRUSION CONDITION DESCRIBED ABOVE. THE MALFUNCTION DID NOT RECUR WHEN THIS FOOTSWITCH WAS USED WITH A LASER SYSTEM KNOWN TO PERFORM WITHIN SPECIFICATIONS. TWO ADDITIONAL POSSIBILITIES FOR FOOTSWITCH FAILURE WERE CONSIDERED: 1) THE FOOTSWITCH HAD A FOREIGN OBJECT JAMMED BETWEEN THE SPRING RELIEF ON THE BOTTOM OF THE FOOT PEDAL AND PUSH ROD, AND, 2) A MICROSWITCH MALFUNCTIONED IN CIRCUITRY. CO QUALITY ENGINEERING CONFERRED WITH THE MFR OF THE FOOTSWITCH AND FOUND THAT THE MEAN TIME BETWEEN FAILURE RATE ON THE MICROSWITCH USED IN THE FOOTSWITCH IS A MILLION AND A HALF CYCLES. BASED ON THAT INFORMATION, IT IS UNLIKELY THAT THE MICROSWITCH WAS THE CAUSE OF THE FAILURE. UPON FURTHER DISCUSSION WITH THE FIELD SERVICE ENGINEER, IT IS MOST LIKELY A FOREIGN OBJECT CONTRIBUTED TO THE FAILURE.
REVISION OF LEFT TOTAL KNEE DUE TO MICRO-LOOSENING OF PATELLAR AND FEMORAL COMPONENTS. HAD A LEFT TOTAL KNEE ARTHROPLASTY 10 MONTHS AGO.
H11: CORRECTED DATA-THE BELOW LISTED BLOCKS OF THE ORIGINAL MEDWATCH REPORT WAS CORREECTED OR SUPPLIED AFTER FOLLOW-UP WAS MADE WITH THE USER FACILITY, ATTENDING PHYSICIAN AND CO'S REVIEW OF THE PT'S OPERATIVE REPORTS AS SUPPLIED BY THE PHYSICIAN. USER FACILITY REPORT #: USER FACILITY REPORT # WAS NOT PROVIDED ON THE ORIGINAL REPORT. USER FACILITY REPORTED THEY ONLY ASSIGN A REPORT NUMBER UPON THEIR SUBMITTING THEIR SEMI-ANNUAL REPORT TO THE FDA. USER FACILITY REPORTED THE FACILITY REGISTRATION # IS 050007. SECTION A- BLOCK A1- ADDED PT IDENTIFIER USING CO IDENTIFIER METHOD. SECTION B- BLOCK B1 - CHANGED CHECK MARK FROM PRODUCT PROBLEM TO AN ADVERSE EVENT AFTER FOLLOW-UP WITH ATTENDING PHYSICIAN. BLOCK B2- CHECKED OFF BOX TO INDICATE "REQUIRED SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE" IN ADDITION TO HOSPITALIZATION. ENTIRE SECTION OF ORIGINAL MED-WATCH REPORT WAS LEFT BLANK BY USER FACILITY. FILLED OUT THE ENTIRE SECTION BASED ON FOLLOW-UP WITH USER FACILITY, ATTENDING PHYSICIAN AND OPERATIVE RECORDS. H10. METHOD - 86 OTHER, (PT'S OPERATIVE RECORDS REVIEWED & FOLLOW-UP WITH ATTENDING PHYSICIAN). RESULTS - 200 OTHER (TRAUMA RELATED). CONCLUSION- 68 OTHER (EVENT RESULTS OF A TRAUMA RELATED INCIDENT). CO'S FOLLOW-UP WITH THE ATTENDING PHYSICIAN AND REVIEW OF THE PT'S OPERATIVE RECORDS CONFIRMED THE IDENTIFIED DEVICE WAS SURGICALLY REVISED AFTER AN IMPLANTATION PERIOD OF APPRX TEN (10) MONTHS. ACTUAL MANUFACTURING RECORDS AND DATE COULD NOT BE INVESTIGATED SINCE PATELLAR DEVICE CASECODE WAS NOT AVAILABLE. REPORTEDLY, PT HAD SLIPPED, FELL AND STRUCK THE SUBJECT TOTAL KNEE JOINT. SINCE THIS FALL, THE PT WAS REPORTED TO HAVE DEVELOPED PERSISTENT DISCOMFORT AND SWELLING IN THE SUBJECT KNEE. ARTHROSCOPIC SYNOVECTOMY WAS INITIALLY PERFORMED AT APPROX SEVEN MONTHS POST THE ORIGINAL IMPLANTATION AND WAS REPORTED AS TEMPORARILY BENEFICIAL. THEN, AN OPEN EXPLORATION REVISION SURGERY WAS PERFORMED TO PHYSICALLY EXAMINE THE JOINT'S CONDITION. A REVIEW OF THESE OPERATIVE RECORDS CONFIRMED THE PHYSICIAN REPORTEDLY OBSERVED FIBROUS UNDERGROWTH BENEATH THE CEMENT, AT THE BONE CEMENT INTERFACE OF THE PATELLAR COMPONENT, WHICH INDICATED LOOSENING. THE ATTENDING PHYSICIAN STATED THAT HE DOES NOT BELIEVE A MED-WATCH REPORT WAS WARRANTED FOR THIS EVENT, SINCE IN HIS ESTIMATION IT WAS MOST LIKELY THAN NOT THAT THE LOOSENED COMPONENTS WERE DIRECTLY OR INDIRECTLY THE RESULT OF THE PT'S "SLIP & FALL" TRAUMATIC EVENT. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN PACKAGE INSERT. CURRENT PACKAGE INSERT STATES, IN PERTINENT PART "LOOSENING OF TOTAL KNEE COMPONENTS CAN OCCUR. EARLY MECHANICAL LOOSENING MAY RESULT FROM INADEQUATE INITIAL FIXATION, LATENT INFECTION, PREMATURE LOADING OF PROSTHESIS, COMPONENT MALALIGNMENT OR TRAUMA. LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATIONS INCLUDING OSTEOLYSIS,
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE. A SYRINGE WAS USED TO DEFLATE THE BALLOON. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS CONFIRMED THE DEFLATION DIFFICULTIES. A LEAK WAS NOTED IN THE POLYIMIDE INFLATION LUMEN OF THE SHAFT. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED. THE SHAFT LEAK MAY HAVE CONTRIBUTED TO THE DEFLATION DIFFICULTIES.
DURING AN UNSPECIFIED PROCEDURE, THE NEEDLE BROKE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. REPORTEDLY THE NEEDLE DISENGAGED  FROM THE JAWS. THE NEEDLE WAS RETRIEVED.
IN 1978 RPTR HAD BILATERAL SILICONE BREAST IMPLANTS INSERTED. IN 1983 BOTH IMPLANTS WERE REMOVED AND REPLACED DUE TO A LEFT MASTECTOMY. IN 1992 RIGHT IMPLANT RUPTURED AND BOTH IMPLANTS WERE REMOVED AND REPLACED WITH ANOTHER MFR'S SILICONE COVERED, SALINE IMPLANTS. IN 1994 THESE IMPLANTS WERE ALSO REMOVED WITH NO SPECIFIC REASON NOTED. RPTR C/O PERMANENT DISABILITY, FIBROMYALGIA, CHRONIC FATIGUE SYNDROME, RHEUMATOID ARTHRITIS, MS, AND PROGRESSIVE, PERIPHERAL NEUROPATHY. RPTR HAS HAD GAMMAMUNE INFUSIONS, PLASMA PHERSIS AND TAKEN PREDNISONE OVER A PERIOD OF YEARS TO TREAT THESE CONDITIONS. IMPLANT DATE 2/78, EXPLANT DATE: 3/83.
H6 68 OTHER. #1-USER MAY HAVE CLOWN UP BALLOON TOO QUICKLY. MFG PROCESS AMENDED. #2 USER MAY HAVE PUNCTURED PRODUCT BY INCORRECT PROCEDURE.
ADDITIONAL INFORMATION. #1 - DR. INSERTED NEEDLE INTO VALVE TO INFLATE THE BALLOON AND THE VALVE BROKE AT THE STEM OF THE PRODUCT AND WATER SPURTED OUT.
THE PT WAS HAVING A C-PLASTY CLOSURE OF TRACHEAL CUTANEOUS FISTULA. SIX (DIME TO QUARTER SIZE) BURNS WERE NOTED DOWN THE LEG WHERE GROUNDING PAD WAS. THIS WAS NOTICED AFTER THE PROCEDURE WHEN PAD WAS REMOVED. SURGEON WAS CONTACTED AND ASSESSED THE PT. OINTMENT WAS APPLIED. THE CAUTERY MACHINE AND GROUNDING PAD WERE SENT TO BIOMED FOR EVALUATION. NO PROBLEMS WERE NOTED WITH THE DEVICES.
NOTE: THE INFO CONTAINED IN THIS MDR IS OF THE TYPE CUSTOMARILY HELD IN STRICT CONFIDENCE AND REGARDED AS PRIVILEGED BY CO UNDER 21 CFR 20.61. THEREFORE, CO REQUESTS THAT THE FOOD AND DRUG ADMINSITRATION TREAT THAT PORTION OF THE MDR (AND BASELINE REPORT) RELATING SPECIFICALLY TO THE CO PRODUCT AS CONFIDENTIAL COMMERICLA INFO UNDER 21 CFR 803.9 (B). A4. CO MADE TWO ATTEMPTS TO SEEK WEIGHT OF PT AND WAS NOT ABLE TO OBTAIN THIS INFO FROM THE USER FACILITY. EFFORT IS CLOSED. H.3 & H.6. PRODUCT WAS NOT RETURNED TO CO FOR EVALUATION. H.10 IT WAS NOTED THAT THE BURNS WERE THIRD AND SECOND DEGREE AND TREATED WITH SILVADENE CREAM. H.10. IT WAS NOTED THE EXCESS HAIR WAS ON THE PLATE. INSERT DOES INDICATE TO REMOVE EXCESSIVE HAIR AS NECESSARY.
DURING A CATARACT EXTRACTION PROCEDURE, THE TUBING FROM THIS OPHTHALMIC MICROSURGICAL ACCESSORY PACK WOULD NOT ALLOW FOR ASPIRATION. ANOTHER PACK WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F OF THIS MEDWATCH WAS COMPLETED BY THE MRR. DATE ENTERED IN SECTION F6. IS DATE OF EVENT.
THE CO REP GAVE RPTR THE NUMBERS 90-5181, 90-5241, 90-5341, 90-441 AS NUMBERS FOR ORDERING STERILE DISPOSABLE CUFFS. PRODUCT USED FROM 11/7/95 TILL 5/17/96 AS IF IT WAS STERILY PACKAGED. RPTR WAS TOLD TODAY THESE ARE NOT STERILE. PACKAGE NOT MARKED NONSTERILE. NORMAL USE FOR THIS PRODUCT IS IN A NONSTERILE SETTING. OCCASIONALLY RPTR USED IT ON A STERILE FIELD. RPTR UNABLE TO TRACK WHEN THIS PRODUCT WAS USED IN A STERILE SETTING OR IF IT WAS THIS PRODUCT OR OTHER CO'S PRODUCT. IT WAS A STAFF ERROR USING THIS PRODUCT IN A STERILE SETTING IF NOT MARKED STERILE. IT WAS CO REP'S ERROR IN GIVING WRONG PRODUCT NUMBER. PACKAGING OF PRODUCT IS THE SAME FOR STERILE AND UNSTERILE CUFFS. RPTR FEELS THIS IS POOR AND CONFUSING AND PACKAGES NEED TO BE STAMPED "UNSTERILE" WHEN PACKAGED IN "STERIBLE" PEEL OPEN PACKAGES.
PERFUSIONIST NOTICED BLOOD IN LINE/POSSIBLE RUPTURE.
H-10 SECTION A ALL UNK INFO REQUESTED BUT NOT REC. H-10- SECTION F ALL INFO PROVIDED BY MFG. H-11-SECTION F-10 DEVICE CODE 1052 LABELED. INTER#061996080042.
A PT RECEIVED HIS FIRST TREATMENT ON 9/12/96 INTO ACNE SCARS AT THE CHEEKS. ON 9/16/96, THE PT NOTED AND PRESENTED WITH ERYTHEMA, SWELLING, AND "CRUSTING" AT A LEFT CHEEK TREATMENT SITE. THE PHYSICIAN DIAGNOSED A NECROSIS; ORAL DICLOXACILLIN AND TOPICAL BACTROBAN WERE PRESCRIBED. ON 9/20/96 AND 9/26/96, THE PT PRESENTED WITH PERSISTENT ERYTHEMA AT THE LEFT CHEEK TREATMENT SITE; NO ADD'L MEDICAL TREATMENT WAS PRESCRIBED.
THE TUBING IS DEFECTIVE. THE PORTION OF THE IV TUBING THAT CONTAINS THE DRIP CHAMBER VENT SLIDE CLAMP IS MISSING FROM THE IV SET. THE DRIP CHAMBER IS OPEN TO THE ENVIRONMENT DUE TO THE MISSING TUBING.
AT AN ATTEMPT TO PRIME ON A DIALYSIS MACHINE, THE MACHINE WOULD NOT PRIME. A BROKEN BLOOD PUMP ROTOR SPRING WAS FOUND. THERE WAS NO PT INVOLVEMENT.
THE MEDICAL EQUIPMENT SERVICE TECH (MES) FOUND A BROKEN BLOOD PUMP ROTOR SPRING AND REPLACED IT WITH A NEW ONE. THERE WERE NO RELATED CPF DEFECTS REPORTED. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT THE SPRING WAS BROKEN IN FOUR PIECES. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE DIFFICULTIES WITH THE ATERIAL AND VENOUS PRESSURES THE FACILITY HAD AS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY TWO BROKEN ROTOR SPRINGS. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRETIVE ACTION REVIEW PROCESS. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. DATE 10/7/96. TRAINING REQUIRED? N. REPORT ATTACHED? N.
THE DEVICE WAS USED DURING A V.A.T.S PROCEDURE. IT WAS REPORTED BY THE REP AT FIRING PROCESS, THE INSTRUMENT WAS BROKEN. THE CASE WAS COMPLETED WITH A NEW INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D10-INFORMATION NOT PROVIDED BY AFFILIATE. H4-INFORMATION NOT AVAILABLE. CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "FELL APART" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
PLASTIC SHARD FOUND IN CASSETTE OF IV TUBING. PARTICLE LIKELY SHEARED OFF OF THE INSIDE OF THE BURETTE INJECTION PORT.
THE CUSTOMER EXPERIENCED A PROBLEM WITH THE PIGGYBACK SET UP. A 500ML CONTAINER OF AN UNKNOWN SOLUTION WAS CONNECTED TO A 100ML CONTAINER OF UNKNOWN SOLUTION TO BE DELIVERED AT A FLOW RATE OF 100ML/HR. APPARENTLY, THE SOLUTION WAS DELIVERED AT A FLOW RATE OF 100ML/HR. APPARENTLY, THE SOLUTION WAS DELIVERED IN APPROX 5 MINUTES. NO PT INJURY. NO ADD'L PT INFO AVAILABLE. IT SHOULD BE NOTED THAT THE CO SALES REPRESENTATIVE DUPLICATED THIS REPORT FINDING THAT THE SOLUTION IMMEDIATELY FLUSHED BACK UP INTO THE PRIMARY BAG.
THIS EVENT HAS OCCURED OR IS OCCURRING MORE FREQUENTLY THAN IS STATED IN ITS LABELING OR, IF NO PERTINENT STATEMENT IS CONTAINED IN THE LABELING, THAN IS USUAL FOR THE DEVICE. N. THIS EVENT HAS OCCURRED OR IS OCCURRING WITH GREATER SEVERITY THAN IS STATED IN ITS LABELING OR, IF NO PERTINENT STATEMENT IS CONTAINED IN THE LABELING THAN IS USUAL FOR THIS DEVICE. N.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON LOW IMPEDANCE OR HOW THIS WAS DISCOVERED. NO FURTHER INFO IS AVAILABLE.
THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. IT WAS REPORTED BY THE REP AT THE FIRING PROCESS, THE INSTRUMENT WAS BROKEN. TO COMPLETE THE CASE A NEW DEVICE WAS OPENED. THERE WAS NO CONSEQUENCE TO THE PT.
FOLDABLE INTRAOCULAR LENS BROKE AFTER INSERTION INTO EYE. LENS REMOVED AND REPLACED. IMPLANT DATE 9/16/96.
A PT RECEIVED HER FIRST TREATMENT ON 9/9/96 IN THE VERMILION BORDERS AND PERIORBITAL LINES. ON 9/18/96, THE PT NOTED AND PRESENTED WITH "MILD REDNESS" AT ALL TREATMENT SITES. ON 9/24/96, SHE PRESENTED WITH SLIGHT REDNESS, SWELLING, AND ITCHING AT THE TREATMENT SITES; ORAL ATARAX AND PREDNISONE WERE PRESCRIBED. ON 9/30/96, THE PT PRESENTED WITH PERSISTENT SYMPTOMS; TOPICAL TEMOVATE WAS PRESCRIBED. THE PHYSICIAN WAS UNSURE IF THE SYMPTOMS REPRESENTED A HYPERSENSITIVITY.
PAT. PROB. CODE: 1907 - LABELED, PAT. PROB. CODE: 2278 - NOT LABELED, CLINICAL REPORT FORM RECEIVED FROM PHYSICIAN ON 11/5/96 INDICATED THAT THE PATIENT DEVELOPED DIFFUSE URTICARIA ON 9/23/96. ANOTHER PHYSICIAN (NAME UNK) RESCRIBED PREDNISONE AND ATARAX, AND THE URTICARIA RESOLVED ON 9/24/96. THE PATIENT HAS A HISTORY OF URTICARIA AND THE PHYSICIAN COULD NOT CERTAIN THE URTICARIA WAS RELATED TO COLLAGEN. WHEN SEEN, SYMPTOMS WERE RESOLVED AND THE PATIENT CONTINUED TO TAKE ATARAX. THE PHYSICIAN DID NOT BELIEVE THE URTICARIA WAS RELATED TO THE COLLAGEN TREATMENT. THE SYMPTOMS AT THE COLLAGEN INJECTION SITES WERE NOT YET BEEN DIAGNOSED BY THE PHYSICIAN, AND THE PATIENT WAS LAST SEEN ON 9/30/96. 1907: HYPERSENSITIVITY INJECTION SITE. 2278: URTICARIA.
TWO DIFFERENT PTS HAVING INFERTILITY TESTS DONE. SAME PROCEDURE FOR BOTH. ONCE THE BALLOON WAS INFLATED, IT WOULD DEFLATE THROUGH VALVE.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? U.
THE DEVICE WAS USED DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY. IT WAS REPORTED A LOAD CRUNCH WAS HEARD WHEN THE DEVICE WAS FIRED. THE DEVICE DID NOT STAPLE NOR CUT. A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
DEVICE RETURNED WITH NO IDENTIFICATION. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "DID NOT STAPLE OR CUT" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYLCED, FIRED, CUT AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
RESIDENT WAS SITTING IN SHOWER CHAIR RECEIVING A SHOWER WHEN THE SEAT ON THE CHAIR APPEARED TO BREAK AND JUST DROPPED. THE CNA SHOWERING THE RESIDENT WAS ABLE TO GRAB ONTO THE RESIDENT BEFORE HE HIT THE FLOOR. TWO CNA'S EXTRICATED THE RESIDENT FROM THE BROKEN CHAIR AND PLACED HIM IN A RECLINER. RESIDENT WAS CHECKED - NO INJURIES WERE RECEIVED FROM INCIDENT.
DURING A DIALYSIS TREATMENT, BLOOD STOPPED FLOWING TO THE BLOOD TUBING SET. A BROKEN BLOOD PUMP ROTOR SPRING WAS FOUND. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE MEDICAL EQUIPMENT SERVICE TECH (MES) FOUND A BROKEN BLOOD PUMP ROTOR SPRING DURING A VISUAL INSPECTION. THE MES REPLACED THE BROKEN ROTOR AND FUNCTIONALLY TESTED TO MANUFACTURING SPECIFICATIONS. THERE WERE NO PT  INJURIES OR MEDICAL INTERVENTIONS REPORTED. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT BOTH SPRINGS ON THE ROTOR WERE BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT ONE OF THE SPRINGS BROKE IN THREE PIECES AND THE OTHER SPRING BROKE IN FOUR PIECES. THE ABOVE INFO INDICATES THAT THE DIFFICULTIES THE FACILITY HAD WITH THE BLOOD FLOW AS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY TWO BROKEN ROTOR SPRINGS. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED; NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO. REPORT ATTACHED? NO.
DURING ROUTINE TESTING, THE DEVICE WAS POWERED ON WITHOUT A DEFIBRILLATION CABLE ATTACHED, BUT ALLEGEDLY DID NOT DISPLAY AN EXPECTED CONNECT ELECTRODES MESSAGE. THE DEVICE WAS THEN CINNECTED TO A SIMULATOR THROUGH AN ATTACHED DEFIBRILLATION CABLE, AND WHEN AN INPUTTED VENTRICULAR FIBRILLATION WAS ANALYZED, THE DEVICE REPORTEDLY WOULD NOT APPROPRIATELY ADVISE SHOCK.
AN EVALUATION BY CO DETERMINED AN INTERMITTENT FAILURE OF COMPONENT, U10, ON THE DEVICE MAIN PCB ASSEMBLY. THE DEVICE WILL BE REPAIRED AND RETURNED TO THE FACILITY FOR USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEQND TO PROVIDE ADD'L INFO ON THIS EVENT TO FDA.
THE DEVICE WAS USED DURING A TOTAL GASTRECTOMY. IT WAS REPORTED THE FIRING KNOB WAS BROKEN ON THE THIRD FIRING. THERE WAS NOTHING WRONG WITH THE INSTRUMENT UNTIL DR CLOSED THE CLOSING LEVER. THE CASE WAS COMPLETED WITH A NEW DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D10-INFORMATION NOT PROVIDED BY AFFILIATE. H4,D5-INFORMATION NOT AVAILABLE. CONCLUSION: BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUCNTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
PT WAS TREATED ON 7/17/95. THE PT DEVELOPED TOOTH PROBLEMS IN APPROX 9/95 (EXACT DATE UNK). AN ENDODONTIST (NAME UNK) TOLD THE PT SHE HAD "REJECTED ONE OF HER CENTRAL INCISORS." THE ENDODONTIST REVIEWED HER MEDICAL HISTORY, INCLUDING HER HISTORY OF COLLAGEN TREATMENTS AND ELEVATED ANA. HE INITIALLY TOLD HER THE TOOTH PAIN COULD POSSIBLY BE RELATED TO THE COLLAGEN. AFTER SEEING THE X-RAYS AND REVIEWING ALL INFO, THE DISCUSSION ABOUT COLLAGEN WAS "DROPPED." IT WAS UNK WHAT THE ENDODONTIST'S IMPRESSION OF CAUSALITY WAS AFTER REVIEW OF ALL PERTINENT INFO. THE CONSULTING PHYSICIAN BELIEVED THE TOOTH PROBLEM WAS MOST PROBABLY RELATED TO CHILDHOOD TRAUMA. THE ENDODONTIST PERFORMED A ROOT CANAL PROCEDURE IN APROX 9/96.
ON 19 MAY 1998, A CONSULTING PHYSICIAN REPORTED THAT THE SYMPTOMS HAD RESOLVED. NO DIAGNOSIS OR ETIOLOGY HAD BEEN DETERMINED, & THE PHYSICIAN BELIEVED NO DIAGNOSIS OR ETIOLOGY WOULD BE DETERMINED.
PT UNDERWENT INSERTION OF NAIL ON 7/2/96 FOR LEFT HIP FRACTURE. ON 7/14/96, A "POP" WAS HEARD WHILE MOVING THE PT. X-RAYS SHOWED SECOND FRACTURE OF FEMUR NEAR END OF THE NAIL, CLOSE TO INFERIOR SCREW #40. THE PT RETURNED TO SURGERY 7/16/96 FOR REMOVAL OF THE NAIL AND INSERTION OF ANOTHER NAIL.
PLAINTIFF'S ALLEGES" INJURIES AND DAMAGES". MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT.
PLAINTIFF ALLEGES "INJURIES AND DAMAGES". MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. NO SAMPLE RECEIVED. PAST HISTORY OF COMPLAINTS OF THIS TYPE HAVE BEEN DUE TO NICKING, SUTURING AND TISSUE INGROWTH OF THE CATHETER.
REPORT OF ALLEGED " ALL LEDS ON, SINGLE TONE ALARM NO VOLUME DELIVERED. NO PT HARM".
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F. TESTING BY MFR FOUND DEVICE WOULD NOT CYCLE, WITH ALL LEDS AND A CONSTANT SINGLE TONE AUDIBLE ALARM, DUE T INTEGRATED CIRCUITS U9 AND U28 ON THE LOGIC BOARD BEING OUT OF SPECIFICATION. REPLACED U9 AND U28.
SUMMARY OF EVALUATION: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION BUT HAS BEEN RETAINED BY THE HOSP. ATTEMPTS TO OBTAIN THE DEVICE WERE UNSUCCESSFUL. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFG. THE INFO PROVIDED SUGGESTS THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE, BUT RATHER WOULD BE RELATED WITH THE PT.
EXCHANGE RIGHT BREAST IMPLANT. BILATERAL CAPSULECTOMIES. REMOVAL LEFT BREAST IMPLANT.
BILATERAL BREAST IMPLANT EXCHANGE DUE TO CAPSULOTOMY. REMOVAL OF BREAST IMPLANT.
TWO IMPLANTS PLACED ON 3/20/96. 1 NEVER INTEGRATED AND WAS REMOVED.
THE RETURNED IMPLANT WAS EVALUATED AND MET SPECIFICATIONS. THERE WAS YELLOWISH RESIDUE ON THE SURFACE WHICH INDICATES THE PRESENCE OF INFECTION. NO MEDICAL HISTORY HAS BEEN RECEIVED (WHICH COULD INDICATE IF ANY PT HEALTH ISSUES ARE INVOLVED). INFECTION IS THE LIKELY CAUSE OF FAILURE.
DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. THE NEEDLE DISENGAGED FROM THE JAWS. THE NEEDLE WAS RETRIEVED WITHOUT INCIDENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE TIE POST BROKE OFF THE TROCAR WHILE THE DEVICE WAS BEING REMOVED. THE PIECE FELL INTO THE PT AND WAS RETRIEVED. THERE WAS NO CONSEQUENCE TO THE PT.
H4: INFO UNAVAILABLE, DEVICE NOT RETURNED.
PT WAS PRESENTED WITH CARDIAC TAMPONADE AND A LARGE EFUSION. PHYSICIAN WENT IN WITH A WIRE GUIDE, MANIPULATING SEVERAL TIMES TO ASSURE PLACEMENT IN PERICARDIAL SPACE. UPON ADVANCEMENT OF THE CATHETER, DIFFICULTY WAS ENCOUNTERED AND THE CATHETER WITHDRAWN. THE CATHETER BEGAN SEPARATING UPON WITHDRAWAL. SOME FRAGMENTS REMAINED IN THE CHEST WALL. THE PT WAS TAKEN TO  SURGERY WHERE THE FRAGMENTS WERE REMOVED. CO CAN ADVISE THIS CATHETER WAS PURCHASED IN 1992 AND WAS LABELED WITH A THREE YEAR EXPIRATION DATE.
H. 6) METHOD-DEVICE NOT RETURNED TO ASSIST IN EVALUATION. 6) CONCLUSIONS-SEE ATTACHED EVALUATION SUMMARY. A. 1) UNABLE TO OBTAIN THIS INFO. 2) UNABLE TO OBTAIN THIS INFO. NO PRODUCT WAS RETURNED FOR EVALUATION. HOWEVER, FROM THE AVAILABLE INFO, THE DEVICE WAS PURCHASED IN 12/92, AND WAS UTILIZED PAST IT'S LABELED EXPIRATION DATE. MOST LIKELY, THIS CONTRIBUTED TO THE DIFFICULTY ENCOUNTERED.
FOLLOWING PREDILATATION WITH A 2.5MM BALLOON, THE STENT/BALLOON CATHETER WAS ADVANCED BUT FAILED TO PASS THE PROXIMAL RIGHT CIRCUMFLEX ARTERY. UPON ATTEMPTED WITHDRAWAL, THE STENT SLIPPED OFF THE BALLOON CATHETER AND REMAINED IN THE LEFT MAIN. THE STENT WAS REMOVED SEVERAL HRS LATER.
DEVICE NOT RETURNED FOR EVALUATION. PT INFO WAS NOT ABLE TO BE OBTAINED.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT ADVANCE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
4/23/97-SUPLEMENTAL REPORT #1 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
REVISION SURGERY WAS PERFORMED ON 8/30/96 TO REMOVE THE SUBJECT FEMORAL HIP HEAD, BIPOLAR LINER 85-8263 MDR REPORT# 1219655-1996-0012, AND BIPOLAR SHELL 85-8247 MDR REPORT# 1219655-1996-0013, FOLLOWING DISCOLORATION OF THE FEMORAL HEAD FROM THE BIPOLAR LINER.
H2-DIMENSIONAL INSPECTION OF RETURNED HIP HEAD COMPONENT FOUND DEVICE TO MEET ALL SPECIFICATION REQUIREMENTS. DIMENSIONAL AND CANTILEVER TESTING OF ONE HIP HEAD FROM THE SAME BATCH MET SPECIFICATION REQUIREMENTS. ADDITIONALLY, A REVIEW OF THE PRODUCTION BATCH RECORDS FOR THIS LOT FOUND DIMENSIONS TO MEET SPECIFICATION REQUIREMENTS. NO FURTHER INVESTIGATION IS PLANNED.
REPLACE BILATERAL BREAST IMPLANTS THAT HAD CAPSULIZED.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
BILATERAL BREAST IMPLANT WITH CAPSULECTOMIES WERE EXCHANGED.
PT RECEIVED HER FIRST TREATMENT ON 9/16/96, IN THE NASOLABIAL FOLDS, PERIORBITAL LINES, AND VERMILION BORDER. IMMEDIATELY AFTER THE TREATMENT, THE PT NOTED SWELLING AT THE TREATMENT SITES WHICH THE PHYSICIAN ATTRIBUTED TO THE INJECTION PROCEDURE. ON 9/17/96, THE PT NOTED REDNESS, SWELLING, AND INDURATION AT THE TREATMENT SITES. ON 9/30/96, SHE PRESENTED WITH PERSISTENT SYMPTOMS. THE PHYSICIAN DIAGNOSED A HYPERSENITIVITY; INTRAMUSCULAR ARISTOCORT, ORAL PREDNISONE, AND TOPICAL TEMOVATE WERE PRESCRIBED.
ON 10/11/96, THE PATIENT REPORTED INTERMITTENT ERYTHEMA AND SWELLING AT THE INJECTION SITES, EXACERBATED WITH VASODILATATION. SHE REPORTED THE ONSET OF SLIGHT NAUSEA AND FATIGUE ON APPROX. 10/4/96 WHICH SHE ASSOCIATED WITH THE PREDNISONE SHE WAS TAKING FOR THE ERYTHEMA AND SWELLING. THE PATIENT HAD NOT NOTIFIED THE PHYSICIAN OF THE NAUSEA AND FATIGUE; THE PHYSICIAN COULD NOT COMMENT ON WHETHER THE NAUSEA AND FATIGUE WERE PRODUCT RELATED WITHOUT SEEING THE PATIENT. ON 10/18/96, THE SYMPTOMS WERE IMPROVED; THE PATIENT WAS INSTRUCTED TO APPLY TOPICAL VITAMIN K. ON 12/10/96, AFTER INGESTION OF WINE, THE INJECTION SITES BECAME RED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIP WOULD NOT FULLY FORM WHEN APPLIED TO STRUCTURE. THE SURGEON SQUEEZED AS HARD AS HE COULD. AFTER 3 OR 4 MALFORMED CLIPS, APPLIER BEGAN WORKING PROPERLY. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENTS WERE RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENTS WERE CYLCED, FED, AND FORMED THE CLIPS WITHIN DESGIN SPECIFICATIOIN WHEN TESTEDL. IT WAS CONCLUDED THAT THE INSTRUMENTS WERE CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
DURING ATHERECTOMY PROCEDURE, THE GUIDE WIFE FRACTURED LEAVING A PORTION OF THE WIRE IN THE RIGHT CORONARY ARTERY. THE PT BECAME HEMODYNAMICALLY UNSTABLE AND WAS TAKEN FOR EMERGENT CORONARY ARTERY BYPASS SURGERY AND WIRE REMOVAL. THE PT WAS STABLE FOLLOWING SURGERY.
DURING ATHERECTOMY PROCEDURE, WIRE FRACTURED LEAVING A PORTION OF WIRE IN RIGHT CORONARY ARTERY. PT BECAME HEMODYNAMICALLY UNSTABLE AND WAS TAKEN FOR EMERGENT CORONARY ARTERY BYPASS SURGERY AND WIRE REMOVAL.
PT WAS SITTING ON 3 IN 1 BSC. PT DID NOT PROPERLY ATTACH THE BUCKET WHICH THEN DID PINCH HER POSTERIOR THIGH WHEN SITTING ON THE DEVICE WHICH RESULTED IN A 1/2 CM NONDRAINING WOUND. CASE MGR RE-EDUCATED THE PT ON PROPER USE AND STORAGE OF THE 3 IN 1.
A PHARMACY TECHNICIAN REPORTED THAT A CUSTOMER COMPLAINED OF LOWER BLOOD GLUCOSE READINGS WITH CO'S DEVICE LOT 1K522A. SHE COULD GIVE NO FURTHER INFO. THE CO'S REP CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFO. THE CUSTOMER, A TYPE II DIABETIC, REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH CO'S DEVICE. SOME TIME IN JUNE OF 1996 THE PT PERFORMED A SIDE BY SIDE BLOOD GLUCOSE COMPARISON WITH CO'S DEVICE AND ANOTHER CO'S TEST STRIPS LOT UNKNOWN). HE OBTAINED RESULTS OF 50 AND 284 MG/DL RESPECTIVELY. HE PERFORMED NO OTHER BLOOD GLUCOSE TESTS WITH THE TEST STRIPS BECAUSE HE FELT THEY WERE READING SIGNIFICANTLY LOW. SOME TIME AT THE BEGINNING OF 7/96, THE PT RETURNED THE TEST STRIPS TO THE PHARMACY FOR A REFUND. THE DESICCANT IS IN THE BOTTLE. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN THE COMPARISON WAS PERFORMED. THE PT DID NOT PERFORM A NORMAL CONTROL SOLUTION TEST AT ANY TIME. SOME TIME LAST WEEK, THE PT PERFORMED A CHECK STRIP TEST ON HIS METER AND OBTAINED A RESULT WITHIN RANGE. HE COULD NOT REMEMBER THE SPECIFIC RESULT. THE PT WAS UNWILLING TO PERFORM A CHECK STRIP TEST WITH THE REP. THE PT DOES NOT KNOW HIS LAST HEMOGLOBIN A1C TEST RESULT. THE PT WAS UNWILLING TO PERFORM A CHECK STRIP TEST WITH THE REP. THE PT DOES NOT KNOW HIS LAST HEMOGLOBIN A1C TEST RESULT. THE PT STATED THAT THE LOWER BLOOD GLUCOSE READING HE OBTAINED WITH CO'S DEVICES COULD HAVE CAUSED HIM TO ADJUST HIS INSULIN INCORRECTLY.THE PHARMACY TECHNICIAN WILL RETURN THE PT'S TEST STRIPS TO CO FOR EVAL.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 8/28/96. ONE OPENED BOTTLE, CONTAINING 6 STRIPS WITH DESICCANT WAS RETURNED TO CO FOR EVAL. THE TEST RESULT OF THE RETURNED BOTTLE CONFIRMED THE LOW BLOOD GLUCOSE READING REPORTED BY THE CUSTOMER. FURTHER EVAL OF THE DESICCANT INSIDE THE RETURNED BOTTLE INDICATES THE LOW BLOOD GLUCOSE READING FROM THE RETURNED STRIPS IS MOST LIKELY THE RESULT OF THE STRIPS NOT BEING PROTECTED BY THE DESICCANT DUE TO THE OBSERVED LOW PERCENT MOISTURE CAPACITY. THE SOURCE OF MOISTURE EXPOSURE IS UNKNOWN. ALL THE RESULTS OF THE RETENTION SAMPLE TESTS FOR LOT 1K522A MEET THE SPECS FOR THE BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE RESULTS OF THE RETENTION SAMPLES TESTS AND TREND ANALYSIS, CO CONCLUDES THAT PROBABILITY THAT THIS WAS A PRODUCT MALFUNCTION IS LOW AND THAT IT IS UNLIKELY TO RECUR. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? NA IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? NA IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N.
PT RECEIVED HER SECOND TREATMENT ON 8/28/96 WITH TWO FORMULATIONS OF COLLAGEN INTO THE HORIZONTAL FOREHEAD LINES, GLABELLA, NASOLABIAL FOLDS, AND UPPER AND LOWER LIPS; IT WAS UNKNOWN IF THE VERMILION OR VERMILION BORDER WAS INJECTED. ON 9/16/96, THE PT WAS NOT HAPPY WITH THE RESULTS OF THE TREATMENT; WHEN SEEN THAT DAY, SHE HAD LITTLE RAISED BEADS AT THE HORIZONTAL FOREHEAD LINES WHICH THE PHYSICIAN BELIEVED WAS THE COLLAGEN MATERIAL. THE EXACT DATE OIF ONSET OF THE BEADS WAS UNKNOWN. WARM COMPRESSES AND MASSAGE WERE PRESCRIBED. ON 9/26/96, THE PT TELEPHONED THE OFFICE AND REPORTED THAT THE TREATED AREAS WERE "GETTING WORSE". ON 9/30/96, SHE WAS SEEN WITH RAISED, RED WELTS WITHOUT INDURATION AT THE HORIZONTAL FOREHEAD LINES AND PINK, RAISED WELTS AT THE NASOLABIAL FOLDS. THE PHYSICIAN DIAGNOSED A HYPERSENITIVITY AND PRESCRIBED ORAL PREDNISONE IN A TAPERING DOSE, ORAL ATARAX, AND A TOPICAL CORTISONE CREAM.
ON 4/14/97, FOLLOW UP WAS RECEIVED: THE PATIENT WAS LAST SEEN ON 3/6/97; THE SYMPTOMS HAD RESOLVED ON 1/23/97.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIP APPLIER WAS SPITTING CLIPS. THE CLIP APPLIER WAS FROM ANOTHER CO CUSTOM KIT. NO FURTHER INFO WAS AVAILABLE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B3,6,7,D10-INFORMATION NOT PROVIDED BY USER FACILITYH4,D5,6-INFORMATION NOT AVAILABLE.G3: USER FACILITY WAS INCORRECTLY SELECTED ON INITIAL MEDWATCHH6: CODE 400(OTHER): YIELDED JAWS
RESIDENT WAS FOUND WITH A 5CM X 9CM DISCOLORED AREA ON L CHEEK WITH 2 SMALL BLACKENED CIRCLES IN UPPER PORTION. AREA WAS IN SHAPE OF CALL LIGHT WHICH WAS WITHOUT THE PROTECTIVE PLASTIC COVER BUT DID HAVE A LIGHT, CLEAR PLASTIC OVER. PLASTIC NOTED TO HAVE CONDENSATION AT TIME RESIDENT FOUND. UNABLE TO DETERMINE HOW ACTUALLY OCCURRED.
NOTICE OF IDE REVISION SURGERY. (IDE STUDY G870035)
H6-68 PT INVOLVED IN AUTOMOBILE ACCIDENT WITH DIRECT IMPACT OF KNEE. REVISION SURGERY DUE TO TRAUMA, NOT DEVICE RELATED. DEVICE FAILURE DUE TO EXTERNAL FACTORS.
A PT WAS SKIN TESTED ON 7/12/96 WITH NEGATIVE RESULTS, AND RECEIVED HER FIRST TREATMENT ON 8/15/96 WITH TWO FOMULATIONS OF COLLAGEN IN THE ORAL COMMISSURES, VERTICAL LINES ABOVE THE UPPER LIP, AND CHIN. ON 8/27/96, THE PT NOTED AND PRESENTED WITH SWELLING AND INDURATION AT THE SKIN TEST SITE. A DIAGNOSIS WAS NOT OFFERED; NO MEDICAL OR SURGICAL INTERVENTION WAS PRESCRIBED. ON 9/7/96, THE PT PRESENTED WITH ERYTHEMA AND SWELLING AT THE ORAL COMMISSURE TREATMENT SITES. THE PHYSICAL DIAGNOSED A HYPERSENSITIVITY; ORAL MEDROL AND TOPICAL TRIAMCINOLONE WERE PRESCRIBED. ON 9/9/96, THE PT PRESENTED WITH PERSISTENT, BUT IMPROVED SYMPTOMS; ORAL MEDROL WAS PRESCRIBED. ON 9/18/96, THE PT PRESENTED WITH PERSISTENT SYMPTOMS; TOPICAL TRIAMCINOLONE WAS PRESCRIBED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THE CLIPS WERE MALFORMED AND DROPPED (DID NOT FALL INTO THE PT). THE DR TRIED SAME PROCEDURE AGAIN, THEN CLIP COULD NOT FEED INTO JAW. DR USED A NEW DEVICE AND COMPLETED THE OPERATION. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D10-INFORMATION NOT PROVIDED BY AFFILIATE. H4,8,D5-INFORMATION NOT AVAILABLE. CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
FACILITY ALLEGES: 58 YEARS OLD FEMALE PT ON HEMODIALYSIS VIA PERNCATH; ABOUT ONE HOUR INTO TREATMENT IS NOTED TO BE "SNORING LOUDLY:, UNRESPONSIVE; VENOUS LINE FOUND TO BE DISCONNECTED FROM LIMB CATHETER. EBL200 TO 4300CC. LINES WERE CLAMPED, PT PLACED IN TRENDELENBURG POSITION, BOLUS OF NORMAL SALINE GIVEN. PT WENT INTO CARDIAC ARREST. CPR INITIATED, PT INTUBATED BY PARAMEDICS AND TRANSPORTED TO LOCAL EMERGENCY ROOM. AT THE TIME OF TRANSPORT B/P 115/60. PULSE 80 WITH INFREQUENT SPONTANEOUS RESPIRATIONS. FACILITY USES A LINE OUT OF THESE LOTS NUMBER: R6J015-R6B034A-R6E053, R6H113.
EVALUATION RESULTS: TO EVALUATE THIS EVENT, DYNAMIC TESTS WERE CONDUCTED WHICH SIMULATED ACTIONS OR MOTIONS THAT MIGHT OCCUR DURING AN ACTUAL DIALYSIS TREATMENT. THE TESTING WAS PERFORMED WITH VARIOUS CATHETERS AND BLOODLINES AS WELL. THE RESULTS OF THE TESTING SHOWED THAT THE NMC PATIENT CONNECTOR HAD HIGHER HOLDING FORCES THAN MOST COPETITORS AND WAS EQUIVALENT TO THE LEADING COMPETITOR IN THESE AREAS. THE RESULTS OF THE INVESTIGATION DETERMINED THAT USER ERROR CONTRIBUTED TO THE EVENT.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE CLIPS WOULD NOT CLOSE. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: YIELDED JAWS. RESULTS OF EVAL: CONCLUSION-BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL AND FUNCTIONAL RESULTS, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND WOULD NOT FORM THE CLIPS PROPERLY ON BOTH OF THE RETURNED INSTRUMENTS. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE JAWS OCCURRED. HOWEVER, IT APPEARS LIKELY THAT THE INSTRUMENTS MAY HAVE BEEN CLOSED OVER A HARD OBJECT. THIS INQUIRY WAS ORIGINALLY REPORTED AS AN RPO (RECORD PURPOSE ONLY). COMMENTS-IF THE JAWS ARE TORQUED OR CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT FORM THE CLIPS PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
PT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DURING 7/96 FOR TREATMENT OF RHEUMATOID ARTHRITIS WITH ENDSTAGE DEGENERATIVE JOINT DISEASE. HE WAS DOING WELL UNITL A FEW WEEKS POSTOPERATIVELY WHEN HE BEGAN TO DEVELOP RECURRENT VARUS DEFORMITY OF THE KNEE AND PAIN. HE HAD DECREASED RANGE OF MOTION. RADIOGRAPHIC TAKEN IN PHYSICIAN'S OFFICE REVEALED SUBSIDENCE OF THE TIBIAL COMPONENT. THE MEDIAL PORTION OF THE IMPLANT APPEARED TO HAVE "SUNK DOWN INTO THE BONE". INTRAOPERATIVELY, IT WAS NOTED THAT THE TIBIAL COMPONENT HAD SUBSIDED ABOUT FIVE OR SIX MILLIMETERS. THE TIBIAL COMPONENT WAS REMOVED AND REPLACED. REMOVED COMPONENTS WERE THE TIBIAL BASEPLATE, TIBIAL STEM, TIBIAL INSERT, AND SPACER. UNDERNEATH THE MEDIAL SIDE, THE BONE WAS FOUND TO BE VERY SOFT. ACUTE INFLAMMATION WAS PRESENT, BUT THERE WAS NO INFECTION.
DURING A LENS IMPLANTATION PROCEDURE, THE LENS BROKE INTO THREE PIECES. DURING THE RETRIEVAL OF THESE PIECES, THE IRIS OF THE PT'S LEFT EYE WAS LACERATED. THE AREA WAS SUTURED AND A NEW LENS IMPLANTED WITHOUT FURTHER INCIDENT.
LENS IS IN THE PROCESS OF EVALUATION. ADD'L INFO WILL BE SUBMITTED AS A FOLLOWUP REPORT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THE CLIPS WERE LOST FROM THE RELOAD CARTRIDGE. THE PT CONSEQUENCE WAS NOT REPORTED.
H6. 68-OTHER. USER FACILITY REPORTED PT UNDERWENT TOTAL KNEE ARTHOPLASTY FOR TREATMENT OF RHEUMATOID ARTHRITIS WITH ENDSTAGE DEGENERATIVE JOINT DISEASE. REVISION PERFORMED DUE TO COMPONENT SUBSIDING ABOUT FIVE OR SIX MILLIMETERS. BONE UNDERNEATH DEVICE WAS FOUND TO BE VERY SOFT.
THE CUSTOMER REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH CO'S TEST STRIPS, LOT #1K502A. SHE OPENED THE BOTTLE APPROX ONE WEEK AGO AND PERFORMED A BLOOD GLUCOSE TEST. THE RESULT WAS 24 MG/DL. SHE DID NOT HAVE HYPOGLYCEMIC SYMPTOMS AND DID NOT BELIEVE THIS READING TO BE ACCURATE, SO SHE PERFORMED A SECOND TEST. THE RESULT WAS 48 MG/DL. SHE PERFORMED APPROX 5 BLOOD GLUCOSE TESTS OVER THE NEXT THREE DAYS AND ALL THE READINGS WERE UNDER 50 MG/DL. SHE STATED THAT HER BLOOD GLUCOSE IS USUALLY IN THE 200 MG/DL RANGE WITH BOTH CO'S TEST STRIPS AND ANOTHER CO'S TEST STRIPS. THE CODE WAS SET CORRECTLY IN THE CUSTOMER'S METER. THE DESICCANT IS IN THE BOTTLE OF DEVICE. SHE DOES NOT HAVE ANY NORMAL CONTROL SOLUTION TO CHECK THE TEST STRIPS FOR ACCURACY. A CHECK STRIP TEST WAS PERFORMED BY HER PHARMACIST APPROXIMATELY ONE MONTH AGO AND THE RESULT WAS WITHIN RANGE (NO SPECIFIC RESULT AVAILABLE). THE CUSTOMER IS VACATIONING AND DOES NOT HAVE HER CHECK STRIP TO PERFORM A CHECK STRIP TEST.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 8/28/96. ONE OPENED BOTTLE, CONTAINING 16 STRIPS WITH DESICCANT WAS RETURNED TO CO FOR EVAL. THE TEST RESULT OF THE RETURNED BOTTLE CONFIRMED THE LOW BLOOD GLUCOSE READING REPORTED BY THE CUSTOMER. FURTHER EVAL OF THE DESICCANT INSIDE THE RETURNED BOTTLE INDICATES THE LOW BLOOD GLUCOSE READING FROM THE RETURNED STRIPS IS MOST LIKELY THE RESULT OF THE STRIPS NOT BEING PROTECTED BY THE DESICCANT DUE TO THE OBSERVED LOW PERCENT MOISTURE CAPACITY. THE SOURCE OF MOSITURE EXPOSURE IS UNKNOWN. ALL THE RESULTS OF THE RETENTION SAMPLES TESTS FOR LOT 1K502A MEET THE SPECS FOR THE BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE RESULTS OF THE RETENTION SAMPLE TESTS AND THE TREND ANALYSIS, CO CONCLUDES THAT THE PROBABILITY THAT THIS WAS A PRODUCT MALFUNCTION IS LOW AND THAT IT IS UNLIKELY TO RECUR. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? NO. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO.
TWO PLAINTIFFS ALLEGE LATEX REACTION CAUSING TREMENDOUS MENTAL STRAIN AND EMOTIONAL STRESS, LOSS OF WORK AND CONSORTIUM.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE PRODUCT OR LOT NUMBER INFO. NO OTHER INFO IS AVAILABLE AS LITIGATION IS PENDING, NO CUSTOMER CONTACT ALLOWED.
PEG TUBE PLACED IN PT. IT WAS NOTED AT TIME OF INSERTION THAT THE TUBE HAD TURNED INSIDE OUT, BUT REMAINED FUNCTIONAL. MD FELT AT TIME OF REMOVAL THAT THE DEVICE NEEDED TO BE INSPECTED.
THE DEVICE WAS USED DURING A LOBECTOMY. IT WAS REPORTED BY THE REP THAT DURING THE LOBECTOMY OF ARTERY/VENE PULMONALIS, STAPLES OF THE DEVICE DID NOT CLOSE CORRECTLY. RESTAPLING WAS NECESSARY. THE PT CONSEQUENCE WAS NOT REPORTED.
THE DEVICE WAS APPLIED TO THE CYSTIC DUCT AND ARTERY. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
RESIDENT WAS FOUND IN ROOM AGAINST THE END OF THE BED, LEANING OUT OF THE CHAIR. THE FOOT PEDALS WERE MOVED OUT OF ALIGNMENT WITH RESIDENT'S LEGS ENTANGLED IN THEM. TWO DAYS PRIOR, REPRESENTATIVE FROM W/C DISTRIBUTOR HAD MADE SAME ADJUSTMENTS ON W/C BUT W/C CONTINUED TO NOT WORK PROPERLY.
THE DEVICE WAS APPLIED TO THE CYSTIC DUCT AND ARTERY. THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
THE DRAIN WAS INSERTED FOLLOWNG AN EMERGENCY APPENDECTOMY ON 8/26/96. ON 8/29, A REGISTERED NURSE ATTEMPTED TO REMOVE THE DRAIN. WHEN SHE ENCOUTERED SOME DIFFICULTY, SHE SPOKE TO HER COWORKERS WHO INDICATED THAT THERE WOULD BE SOME RESISTANCE. THE NURSE THEN RETURNED TO THE PT AND GAVE A FIRM, STEADY PULL. THE DISTAL END FRACTURED OFF IN THE PT AND WAS REMOVED SURGICALLY ON 8/30/96.
VISUAL EXAMINATION OF THE PRODUCT SAMPLE REVEALED THAT THE UNIT WAS RECEIVED WITH A 100CC RESERVOIR. THE DRAIN FRACTURED AT THE SILICONE TUBE APPROX 1 INCH FROM THE HUB AREA. IT WAS ALSO NOTED THAT THE BARIUM TUBE SHOWED A SLANT CUT AT ONE END ABOUT 5 INCHES FROM THE HUB AREA. MICROSCOPIC EXAMINATION REVEALED JAGGED EDGES AT THE FRACTURE SITE AND A SMALL PUNCTURE AT APPROX 075 INCHES FRACTURE SITE. THESE CHARACTERISTICS INDICATE THAT THE DRAIN WAS PUNCTURED BY A SHARP OBJECT DURING IMPLANTATION OR REMOVAL. THE MINIMUM TENSILE STRENGTH SPECIFICATION FOR THIS DRAIN IS 750 PSI AND THE FORCE USED TO IMPLANT OR REMOVE WOULD NEVER REACH THIS VALUE.
MALFUNCTION OF INFLATABLE PENILE PROSTHESIS DUE TO FLUID LOSS.
A MIDLINE CATHETER WAS INSERTED IN THE LEFT MID-FOREARM PER PROCEDURE WITHOUT DIFFICULTY. THE PT IMMEDIATELY EXPERIENCED A SEVERE REACTION COMPLAINING OF NAUSEA, HEADACHE, NUMBNESS OF FACE, SEVERE SHOULDER TO BACK PAIN, SHORTNESS OF BREATH AND DIZZINESS. BLOOD PRESSURE AT 240/120. THE CATHETER WAS REMOVED AND ALL SYMPTOMS SUBSIDED.
PT HAD BEEN WORKING IN THE ER FOR 14 YRS. DURING THIS PERIOD OF TIME PT WAS USING LATEX GLOVES WHICH IRRITATED HER HANDS. LATER ON, AS PT CONTINUED USING LATEX GLOVES, THERE WERE 2 EPISODES IN WHICH SHE EXPERIENCED ABDOMINAL CRAMPING, HEADACHE AND TIGHTNESS OF THROAT. PT DECIDED TO USE VINYL GLOVES. OVER THE PERIOD OF TIME, PT DEVELOPED ASTHMA, SHORTNESS OF BREATH, COUGH AND HAY FEVER. AN ANTIHISTAMINE WAS ADMINISTERED WITHOUT ANY POSITIVE RESULTS. PT WAS REQUIRED TO CARRY AN "EPI-KIT" WEARS A MEDICAL ALERT BRACELET. PT IS NO LONGER WORKING AS AN RN.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE ANY PRODUCT OR LOT NUMBER INFO. REPORTER HAS REQUESTED ANONYMITY, THEREFORE, NO ADD'L INFO COULD BE OBTAINED. MEDWATCH REPORTING NUMBER 1009931.
DR COMPLAINS NEW NEEDLE SHAFT BENDS TOO EASILY. HE HAS BENT MORE THAN ONE. CLAIMS IT BENDS IN MIDDLE AS HE IS APPLYING SIDE TO SIDE PRESSURE IN ORDER TO RE-DIRECT TIP TO TAKE BONE SAMPLE. CO SPOKE WITH CONTACT IN PURCHASING, AS DR WAS UNAVAILABLE. EVIDENTLY, AT ONE TIME THE NEEDLE BROKE AND PT WAS TAKEN TO O.R. FOR REMOVAL. THIS WAS NEVER BROUGHT UP UNTIL CO WENT TO SEE THE ACCOUNT AND IT HAPPENED A WHILE BACK, MAYBE MONTHS AGO.
FACILITY ALLEGES KINK IN ARTERIAL LINE DURING DIALYSIS TREATMENT NOTED BY NURSE WHO STRAIGHTENED THE LINE AND CONTINUED TREATMENT. PT WAS ADMITTED TO THE HOSPITAL WITH DIAGNOSIS OF HEMOLYSIS AND EXPIRED THE NEXT DAY. FACILITY HAS LINE AVAILABLE FOR INVESTIGATION.
DHR REVIEW SHOWED NO INDICATION OF THE DEFECT. LOT MET ALL RELEASE CRITERIA. THE RETURNED PRODUCT SAMPLE WAS VISUALLY EXAMINED AND NO KINKS WERE FOUND. NMC'S BEST INFO STATES THAT KINKS MUST BE VERY SEVERE (>85% OCCLUSION AT BLOOD TEMP.) TO CAUSE HEMOLYSIS. IN ADDITION, THERE ARE MANY CLINICAL INFLUENCES WHICH CAN CAUSE HEMOLYSIS SUCH AS: CONTAMINANTS IN THE DIALYSIS SOLUTION, TEMP. OF THE DIALYZATE ITS OSMOLARITY, A DIFFICULT NEEDLE POSITION CAUSING TRAUMA OF THE RED BLOOD CELLS. MEDICATIONS (DRUG INDUCED) OR PATIENT MEDICAL CONDITION OTHER THAN ESRD.
MD WAS USING THE CAUTERY DEEP WITHIN THE POCKET FOR THE BREAST IMPLANT. THE HANDPIECE ARCED AT THE CONNECTION BETWEEN THE ELECTRODE AND THE HANDPIECE PRODUCING A BURN.
DURING A LAPAROSCOPIC CHOLECYSTECTOM PROCEDURE, THE INSTRUMENT DID NOT FIRE PROPERLY AND THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE FOLLOWING FIELDS DIFFER FROM THE DISTRIBUTOR REPORT: D1, D5, D6 LOT #, D9, SECTION F, SECTION G, H3. THE DEVICE USED DURING THE PROCEDURE WAS NOT RETURNED. SAMPLES FROM THE SAME LOT WERE RECEIVED. NO CORRECTIVE ACTION IS DEEMED NECESSARY FOR THE COMPLAINT OF "BENDS TOO EASILY" OR" NEEDLE BROKE" BECAUSE NO EVIDENCE WAS FOUND DURING THE ANALYSIS TO SUPPORT THE FIELD COMPLAINT. THE UNITS RETURNED WERE SLIGHTLY ABOVE HARDNESS SPECIFICATION. THESES RESULTS ARE DETERMINED NOT TO BE A CONTRIBUTING FACTOR TO THE FIELD COMPLAINT. THE UNITS BEING OF A SLIGHTLY HIGHER HARDNESS WOULD MAKE THEM LESS SUSCEPTIBLE TO BENDING DURING USE. ALSO, ADD'L INFO FROM SALES REPRESENTATIVE SHOWS THAT IT IS UNCLEAR WHEN THE EVENT (BREAKAGE) OCCURRED, WHERE IT OCCURRED, AND WHETHER IT INVOLVED THE CO DEVICE. THE DISTRIBUTOR AND THE USER FACILITY WERE CONTACTED TO OBTAIN ANY ADD'L INFO NEEDED TO COMPLETE THE MEDWATCH FORM 3500A. A COPY OF THE DISTRIBUTOR REPORT WAS RECEIVED. THE USER FACILITY STATED THAT ANY INFO OBTAINED WOULD BE FORWARDED. ANY ADD'L INFO RECEIVED WILL BE FORWARDED TO THE FDA AS A FOLLOW-UP.
IMPLANT WAS PLACED ON 11/91 AND WAS REMOVED ON 5/10/96, SECOND STAGE SURGERY.
THIS REPORT HAS BEEN FAXED TO DR. NO FURTHER INFO AT THIS TIME. CONDITION RECEIVED: USED. INVESTIGATION: IMPLANT UP TO CO'S SPEC. ANALYSIS SUMMARY: NOT ATTRIBUTED TO PRODUCT. CORRECTIVE ACTION: NONE. PREVENTATIVE ACTION: NONE.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE PROPERLY AND THE STAPLES DID NOT FROM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH CO'S TEST STRIPS, LOT # UNKNOWN. HE OPENED THE BOTTLE OF TEST STRIPS APPROX ONE WEEK AGO AND PERFORMED ONE BLOOD GLUCOSE TEST. THE RESULT WAS HIGHER THAN HIS USUAL READINGS WITH ANOTHER TEST STRIPS. HE IMMEDIATELY PERFORMED A NORMAL CONTROL SOLUTION TEST AND THE RESULT WAS APPROX 179 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 112-168 MG/DL. HE PERFORMED A SECOND NORMAL CONTROL SOLUTION TEST AND THE RESULT WAS APPROX 107 MG/DL. THE NORMAL CONTROL SOLUTION WAS SET ON THE CORRECT CODE. THE CUSTOMER PERFORMED A CHECK STRIP TEST WHEN HE PERFORMED THE CONTROL TESTS AND THE RESULT WAS WITHIN RANGE (NO SPECIFIC RESULT AVAILABLE). BECAUSE THE CUSTOMER THREW THE TEST STRIPS AWAY AFTER OBTAINING THE OUT OF CONTROL RANGE READINGS, THE LOT NUMBER IS UNKNOWN. THE CUSTOMER COULD NOT REMEMBER WHETHER THE DESICCANT WAS IN THE BOTTLE OF TEST STRIPS. HE IS REPORTING THE CONTROL RANGE AND CONTROL SOLUTION TEST RESULTS FROM MEMORY AND HE IS NOT CERTAIN OF THE EXACT CONTROL RANGE OR CONTROL TEST RESULTS. HE STATED THAT HE IS CERTAIN THAT THE FIRST READING WAS OUTSIDE OF THE CONTROL RANGE ON THE HIGH SIDE AND THE SECOND READING WAS OUTSIDE OF THE CONTROL RANGE ON THE LOW SIDE.
CUSTOMER REPORTED HAVING DISCARDED THE BOTTLES AFTER OBTAINING THE HIGH AND OUT OF CONTROL RANGE READINGS. INSUFFICIENT INFO WAS PROVIDED BY THE CUSTOMER (NO LOT NUMBER) THEREFORE, NO FURTHER INVESTIGATION IS POSSIBLE. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? NO. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO.
PT WAS READMITTED ON 9/3/936 TO HOSP FOLLOWING COMPLICATIONS FROM A PREVIOUS SURGERY PERFORMED ON 8/5/96 FOR OVARIAN CA WITH MALIGNANCY. A CYSTOGRAM SHOWED A RETAINED PARTIAL DRAIN. THE PT HAD PULLED ON THE DRAIN DURING A COMBATIVE STATE IN THE ICU ON 8/6/96 AND THE DRAIN BROKE OFF. THE ICU NURSE WAS UNAWARE THAT THE TUB3E WAS NOT INTACT. THE PT WAS DISCHARGED ON 8/16/96 WITH HOME HEALTH CARE. ON 9/6/96 THE PT WAS TAKEN TO THE OR FOR EXPLORATORY LAP AND REMOVAL OF PARTIAL DRAIN.
IMPLANT WAS PLACED IN PT AND WAS REMOVED ON 5/13/96 AT SECOND STAGE SURGERY, AS PER DR.
THIS REPORT HAS BEEN FAXED TO DR. NO FURTHER INFO AT THIS TIME. CONDITION RECEIVED: USED. INVESTIGATION: IMPLANT UP TO CO'S SPECS. ANALYSIS SUMMARY: NOT ATTRIBUTED TO PRODUCT. CORRECTIVE ACTION: NONE. PREVENTATIVE ACTION: NONE.
UPON WITHDRAWAL OF THE BALLOON CATHETER THROUGH THE INTRODUCER SHEATH POST PULMONARY VALVULOPLASTY PROCEDURE, THE CATHETER SHAFT BROKE WITHIN THE SHEATH. THE BALLOON AND SHEATH WERE REMOVED AS A UNIT WITHOUT INCIDENT. THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THIS EVENT AND NO PT COMPLICATIONS ENSUED. THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE EVAL INDICATED THE BALLOON MATERIAL WAS SEPARATED FROM THE MAIN SHAFT AT THE PROXIMAL BOND. A SLIGHT KINK WAS NOTED IN THE CATHETER SHAFT APPROX TEN CENTIMETERS FROM THE DISTAL END. ALTHOUGH THE INITIAL INFO RECEIVED INDICATED THE CATHETER SHAFT BROKE, CO'S EVAL OF THE DEVICE REVEALED BALLOON SEPARATION AT THE PROXIMAL BOND. THE SHAFT WAS RECEIVED INTACT. THIS TYPE OF FAILURE COUPLED WITH THE INFO OBTAINED DURING FOLLOW-UP IS INDICATIVE OF RESISTANCE UPON WITHDRAWAL OF THE CATHETER THROUGH THE INTRODUCER SHEATH. THIS AORTIC VALVULOPLASTY BALLOON CATHETER WAS USED IN A PULMONIC VALVULOPLASTY PROCEDURE. CO BELIEVES USER TECHNIQUE CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE.
F10. 2203-BALLOON MATERIAL SEPARATED FROM THE MAIN SHAFT AT THE PROXIMAL BOND.
REVISION SURGERY WAS PERFORMED ON 8/30/96 TO REMOVE THE SUBJECT BIPOLAR LINER COMPONENT 85-8263, BIPOLAR SHELL COMPONENT 85-8247 MDR REPORT# 1219655-1996-0013. AND FEMORAL HEAD COMPONENT 85-3811 MDR REPORT# 1219655-1996-0011, FOLLOWING DISLOCATIONS OF THE FEMORAL HEAD FROM THE BIPOLAR LINER. REFERENCE# 1219655-1996-13/11.
H2-DIMENSIONAL INSPECTION OF RETURNED LINER COMPONENT FOUND DEVICE TO MEET ALL SPECIFICATION REQUIREMENTS. DIMENSIONAL AND CANTILEVER TESTING OF 3 LINERS FROM THE SAME BATCH MET SPECIFICATION REQUIREMENTS. ADDITIONALLY, A REVIEW OF PRODUCTION BATCH RECORDS FOR THIS LOT FOUND DIMENSIONAL TO HAVE MEET SPECIFICATION REQUIREMENTS. NO FURTHER INVESTIGATION IS PLANNED.
TWO IMPLANTS WERE PLACED IN THIS PT. (SE REPORT # 1052120-1996-00010). THIS PARTICULAR IMPLANT WAS PLACED IN THE PT AND REMOVED ON 5/13/96, SECOND STAGE SURGERY. REFERENCED # 1052120-1996-00010.
THE PT'S GRANDDAUGHTER REPORTED THAT HER GRANDFATHER OBTAINED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH CO'S DEVICE LOT 1K508A. ON APPROX 8/7/96, THE PT OPENED A NEW BOTTLE OF TEST STRIPS AND OBTAINED A BLOOD GLUCOSE READING OF 19 MG/DL. BECAUSE HE FELT THIS READING WAS SIGNIFICANTLY LOW, HE DISCONTINUED USE OF THE TEST STRIPS. THE PT HAS NOT TAKEN HIS BLOOD GLUCOSE SINCE APPROX 8/7/96. THE PT'S METER WAS SET TO THE APPROPRIATE CODE. THE DESICCANT IS IN THE CO'S DEVICE BOTTLE. THE PT WAS UNWILLING TO PERFORM A BLOOD GLUCOSE TEST WITH THE REP. THE PT DID NOT HAVE NORMAL CONTROL SOLUTION AVAILABLE TO CHECK THE TEST STRIPS FOR ACCURACY. SOME TIME LAST WEEK, THE PT PERFORMED A CHECK STRIP TEST AND OBTAINED A RESULT WITHIN RANGE. BOTH THE CONTACT AND THE PT COULD NOT REMEMBER THE SPECIFIC RESULT. THEY WERE UNWILLING TO PERFORM A CHECK STRIP TEST WITH THE REP.
CO WAS UNABLE TO CONFIRM CUSTOMER'S COMPLAINT. CUSTOMER REPORTED THAT NORMAL CONTROL SOLUTION TESTING HAS NOT BEEN PERFORMED. ALL THE RETENTION SAMPLE TEST RESULTS FOR LOT 1K508A MEET THE SPECS FOR THE BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE RESULTS OF RETENTION SAMPLE TESTS AND TREND ANALYSIS, CO CONCLUDES THAT THE PROBABILITY THAT THIS WAS A PRODUCT MALFUNCTION IS LOW AND THAT IT IS UNLIKELY TO RECUR. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? NO. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO.
REVISION SURGERY WAS PERFORMED ON 8/30/96 TO REMOVE THE SUBJECT BIPOLAR SHELL COMPONENT 85-8247, BIPOLAR LINER COMPONENT 85-8263 MDR REPORT# 1219655-1996-0013, AND FEMORAL HEAD COMPONENT 85-3811 MDR REPORT# 1219655-1996-0011, FOLLOWING DISOLCOLORATION OF THE FEMORAL HEAD FROM THE BIPOLAR LINER. REFERENCE #1219655-1996-11/13.
H2-DIMENSIONAL INSPECTION OF RETURNED SHELL COMPONENT FOUND DEVICE TO MEET ALL SPECIFICATION REQUIREMENTS. ADDITIONALLY, A REVIEW OF PRODUCTION BATCH RECORDS FOR THIS LOT FOUND DIMENSIONS TO HAVE MEET SPECIFICATION REQUIREMENTS. NO FURTHER INVESTIGATION IS PLANNED.
PT WAS READMITTED ON 9/3/96 TO HOSP FOLLOWING COMPLICATIONS FROM A PREVIOUS SURGERY PERFORMED ON 8/5/96 FOR OVARIAN CA MALIGNANCY. A CYSTOGRAM SHOWED A RETAINED PARTIAL DRAIN. THE PT HAD PULLED ON THE DRAIN DURING A COMBATIVE STATE IN THE ICU ON 8/6/96 AND THE DRAIN BROKE OFF. THE ICU NURSE WAS UNAWARE THAT THE TUBE WAS NOT INTACT. THE PT WAS DISCHARGED ON 8/16/96 WITH HOME HEALTH CARE. ON 9/6/96 THE PT WAS TAKEN TO THE OR FOR EXPLORATORY LAP AND REMOVAL OF PARTIAL DRAIN.
9/26/96 IT WAS REPORTED BY THE DIRECTOR OF RISK MGMT, THAT THE HOSP WILL RETAIN THE SAMPLE FOR POSSIBLE LEGAL PROCEEDINGS. PAST HISTORY OF COMPLAINTS OF THIS TYPE HAVE BEEN DUE TO NICKING, SUTURING AND TISSUE INGROWTH.
IMPLANT WAS PLACED IN PT AND REMOVED AT SECOND STAGE SURGERY ON 5/14/96.
THE PT WAS TAKEN TO SURGERY FOR INSERTION OF A CATHETER TO BE USED FOR HEMODIALYSIS. IN RECOVERY ROOM, A PORTABLE CHEST X-RAY WAS OBTAINED FOR LINE PLACEMENT. TWENTY MINS LATER THE PT DEVELOPED A SEIZURE WITH A DROP IN BP AND O2 SAT. THE SEIZURE ENDED WITHOUT REQUIRING TREATMENT. BP AND O2 SAT IMPROVED. TEN MINS LATER, BP AND RESPIRATIONS AND O2 SAT DROPPED. PT WAS INTUBATED. CARDIAC ARREST. RADIOLOGY CALLED TO SAY THE TIP OF THE CATHETER WAS PROBABLY IN THE RIGHT PLEURAL SPACE. RIGHT CHEST TUBE INSERTED. RETURN WAS SEROSANGUINOUS YIELDING FRANK BLOOD. CHEST TUBE CLAMPED AFTER 1500 CC OF FLUID REMOVED. EMERGENCY RIGHT THORACOTOMY DONE IN RECOVERY ROOM. LARGE RIGHT HEMOTHORAX WAS SEEN. THE CATHETER APPEARED TO BE EXITING THE SUPERIOR VENA CAVA. OPEN CARDIAC MASSAGE DONE. THE PT WAS TRANSFERRED TO OR. SVC PERFORATION WAS REPAIRED. THE CATHETER WAS REMOVED. DESPITE AGGRESSIVE TREATMENT, THE PT EXPIRED AT 3:20 PM. THE EQUIPMENT WAS NOT RETAINED. HOSP IS UNABLE TO DETERMINE IF IT WAS DEFECTIVE.
CONDITION RECEIVED: USED. INVESTIGATION: IMPLANT UP TO CO'S SPECS. ANALYSIS SUMMARY: NOT ATTRIBUTED TO PRODUCT. CORRECTIVE ACTION: NONE. PREVENTATIVE ACTION: NONE.
PT DISCOVERED IN VENTRICULAR TACHYCARDIA. STAFF ON INVESTIGATION, FOUND PUMP INFUSING POTASSIUM PIGGYBACK AT 800+CC/HR. UNKNOWN HOW MUCH POTASSIUM HAD INFUSED AT THAT RATE. PT WAS HYPOTENSIVE BUT RESPONDED POSITIVELY TO CALCIUM CHLORIDE AND REVERTED TO SINUS RHYTHM. BLOOD PRESSURE NORMALIZED. THE PUMP WAS SET WITH AN NS FLUSH BAG ON THE MAIN LINE AND THE POTASSIUM PIGGYBACKED INTO THE NS. THE NURSE WHO HUNG THE PIGGYBACK OBTAINED A NEW PUMP. IT WAS PLUGGED IN. HE STRUNG THE NS AS THE PRIMARY IV BUT DID NOT SET A RATE. THE PIGGYBACK HAD ABOUT 80CC OF FLUID TO INFUSE AND WAS SET AT 60CC/HR. ORIGINAL PUMP BATTERY WAS FOUND TO BE DISCONNECTED INTERNALLY.
PROBLEM: FAILURE TO OSSEOINTEGRATE. CONDITION RECEIVED: USED. INVESTIGATION: IMPLANT UPR TO CO'S SPECS. ANALYSIS SUMMARY: NOT ATTRIBUTED TO PRODUCT. CORRECTIVE ACTION: NONE. PREVENTATIVE ACTION: NONE.
REVISION SURGERY WAS PERFORMED ON 7/29/96 TO REMOVE THE SUBJECT BIPOLAR LINER COMPONENT A BIPOLAR SHELL COMPONENT 85-8243, MDR REPORT# 1219655-1996-0015, FOLLOWING DISLOCATION OF THE INNER HEAD FROM THE LINER COMPONENT.  THE NEED FOR REVISION SURGERY HAS NOT BEEN ATTRIBUTED TO THE INNER HEAD WHICH WAS NOT REMOVED.
H2-DIMENSIONAL INSPECTION OF RETURNED LINER COMPONENT FOUND DEVICE TO MEET ALL SPECIFICATION REQUIREMENTS. DIMENSIONAL AND CANTILEVER TESTING OF 3 LINERS FROM THE SAME BATCH MET SPECIFICATION REQUIREMENTS. ADDITIONALLY, A REVIEW OF THE PRODUCTION BATCH RECORDS FOR THIS LOT FOUND DIMENSIONS TO HAVE MEET SPECIFICATION REQUIREMENTS. NO FURTHER INVESTIGATION IS PLANNED.
PRIOR TO SURGERY, WITH THE PT INTUBATED AND ANESTHETISED AND BEING POSITIONED FOR AN X-RAY, THE TABLE WAS ARTICULATED INTO SIDE TILT. THE TILT WAS TOWARD THE PREVIOUSLY BROKEN PROTECTIVE OVERRIDE CONTROL COVER. THIS ARTICULATION CAUSED THE COVER TO DEPRESS THE LEG SECTION OVERRIDE SWITCH, CAUSING AN INADVERTENT DOWNWARD MOVEMENT OF THE TABLE LEG SECTION. THE PT WAS SUPPORTED BY O.R. PERSONNEL. NO INJURY TO PT OR STAFF.
TABLES AT THE ACCOUNT HAVE BEEN MAINTAINED BY A THIRD PARTY MAINTENANCE ORGANIZATION FOR THE PAST 1 1/2 YRS. THIRD PARTY MAINTENANCE ORGANIZATION ADVISED THE CUSTOMER TO REMOVE THE OVERRIDE COVERS TO PREVENT A RE0CCURRENCE OF THE EVENT. CO SALES REP AND PRODUCT ENGINEERING EXPLICITLY INFORMED THE CUSTOMER THAT UNDER NO CIRCUMSTANCES SHOULD THE COVER BE REMOVED. THE PURPOSE OF THE COVER IS TO PREVENT ACCIDENTAL ACTIVATION OF THE OVERRIDE SWITCHES AND BROKEN COVERS SHOULD BE REPLACED NOT REMOVED. REMOVAL ONLY INCREASES THE LIKELYHOOD OF SUCH AN OCCURRENCE. SALES REP AND CO SERVICE TECH VISITED THE ACCOUNT AND DETERMINED THAT THE PLASTIC SHROUD AT THE TOP OF THE COLUMN WAS SPLIT AND THE OVERRIDE SWITCH COVER WAS MISSING. CUSTOMER HAS BEEN ADVISED TO FOLLOW MFR'S RECOMMENDED PREVENTIVE MAINTENANCE AND REPLACE THE BROKEN COVER. THE CUSTOMER IS ORDERING THE NEEDED PARTS AND WILL HAVE THEIR THIRD PARTY MAINTENANCE GROUP INSTALL THE COVER.
POSSIBLE STUCK EXPIRATORY VALVE ON ANESTHESIA MACHINE. PT EXPERIENCED HIGH AIRWAY PRESSURES, COLLAPSED LUNG, MI AND EXPIRED.
DEVICE WAS BEING UTILIZED FOR A VARICOCELE EMBOLIZATION. THE CATHETER WAS ADVANCED INTO POSITION. ONE COIL WAS PLACED. IN ATTEMPTING TO PLACE THIS SECOND COIL, IT STUCK IN THE CATHETER. A DECISION WAS MADE TO REMOVE THE CATHETER. UPON REMOVAL OF THE CATHETER FROM THE SPERMATIC VEIN, THE COIL DISLODGED AND WENT INTO THE PULMONARY ARTERY. THE COIL WAS SUCCESSFULLY RETREIEVED.
H.6 METHOD-DEVIC3E NOT RETURNED FOR EVALUATION.
IMPLANT WAS PLACED IN PT AND REMOVED AT SECOND STAGE SURGERY ON 5/21/96.
BILATERAL BREAST IMPLANTS REMOVED. DUE TO CONTRACTED CAPSULES.
REVISION SURGERY WAS PERFORMED ON 7/29/96 TO REMOVE THE SUBJECT BIPOLAR LINER COMPONENT AND A BIPOLAR SHELL COMPONENT 85-8262, MDR REPORT# 1219655-1996-0014, FOLLOWING DISLOCATION OF THE INNER HEAD FROM THE LINER COMPONENT. THE NEED FOR REVISION SURGERY HAS NOT BEEN ATTRIBUTED TO THE INNER HEAD WHICH WAS NOT REMOVED. REFERENCE 1219655-1996-14.
H2-DIMENSIONAL INSPECTION OF RETURNED SHELL COMPONENT FOUND DEVICE TO MEET ALL SPECIFICATION REQUIREMENTS. ADDITIONALLY, A REVIEW OF THE PRODUCTION BATCH RECORDS FOR THIS LOT FOUND DIMENSIONS TO HAVE MEET SPECIFICATION REQUIREMENTS. NO FURTHER INVESTIGATION IS PLANNED.
IMPLANT'S HEXAGONAL HEAD STRIPPED WHEN PLACING IN PT AND WHEN REMOVING FROM PT ON THE SAME DAY.
PROBLEM: DAMAGED DURING USE. CONDITION RECEIVED: USED. INVESTIGATION: STRIPPED HEX. MOST LIKELY CAUSE, DR STRIPPED IT AS HE FORCED IT IN. IMPROPER PREP. OF SITE FOR IMPLANT. ANALYSIS SUMMARY: NOT ATTRIBUTED TO PRODUCT. CORRECTIVE ACTION: NONE, AS CO CANNOT CRITIQUE DR'S TECHNIQUES IN HIS OPERATORY. PREVENTATIVE ACTION: NONE.
ORIGINAL REPORT INDICATED BATTERY RECONNECTED BY BIOMEDICAL ENGINEERING AT FACILITY. DEVICE ALARMED "LOW BATTERY" DURING TESTING, BATTERY WAS REPLACED. THE PT HAS FULLY RECOVERED FROM INCIDENT, THE NURSE THAT WAS USING THE DEVICE AT THE TIME HAS BEEN DISCHARGED FROM THE HOSP. HOSP IS CONSIDERING THIS TO BE A "USER ERROR".
PAINFUL GENERATOR AT SITE OF IMPLANTATION.
DURING SURGICAL PROCEDURE (DE-CLOTHING OF AV FISTULA) FOOT OF OPERATING TABLE FLIPPED UPWARDS TO APPROX 50 DEGREE ANGLE. CONTROLS WERE HANGING AT THE HEAD OF THE TABLE. NO ONE IS AWARE OF HAVING TOUCHED THE CONTROL PAD.
DURING THE INVESTIGATION IT WAS DISCOVERED, BY TALKING WITH THE O.R. SUPERVISOR, THAT THE FOOT OF THE TABLE DID NOT "FLIP" UPWARDS AS STATED IN THE MEDWATCH REPORT ORIGINALLY FILED BY THE HOSP. THE MOTION WAS IN FACT, A SLOW POWERED MOVEMENT. SHE STATED THAT SHE HEARD THE MOTOR OPERATING. THE EVENT DID NOT RESULT IN ANY INJURY TO THE PT OR STAFF. A SERVICE TECH WAS DISPATCHED TO THE HOSP TO INSPECT THE TABLE. THE RESULTS OF HIS EVAL SHOWED NO DAMAGE TO THE TABLE, NO IMPROPER OPERATION OF THE TABLE, AND NO APPARENT CAUSE FOR THE TABLE MOVEMENT. FUNCTIONAL TESTS WERE RUN ON BOTH THE HAND CONTROL AND THE TABLE ELECTRICAL SYSTEM SHOWING BOTH TO BE OPERATING WITHIN SPECIFICATIONS. THE UNINTENDED MOVEMENT COULD NOT BE RECREATED AND THE TABLE IS BEING PLACED BACK INTO SERVICE.
COMPLETE LOSS OF ATRIAL SENSING WAS OBSERVED.
REFERENCE SECTION F.10 OF THIS FOR FOR THE EVENT PROBLEM CODES.
PT WITH A CONTINUOUS INFUSION OF PROSTAGLANDIN HAD A CATHETER PLACED IN 7/96. TWO WEEKS AGO, PAIN DEVELOPED IN HER SHOULDER, CHEST, AND ARM ALONG WITH ARM SWELLING. THE LEFT CENTRAL LINE WAS REMOVED AND NEW CATHETER PLACED ON THE RIGHT SIDE.
SURGEON REMOVED A BIPOLAR SHELL COMPONENT DUE TO DISLOCATION. ALSO REMOVED WERE A BIPOLAR LINER COMPONENT 85-8263, MDR REPORT# 1219655-1996-0022, AND A FEMORAL HIP HEAD 85-3811, MDR REPORT# 1219655-1996-0009. THE DEVICES WERE IMPLANTED ON 7/10/96. REFERENCE# 1219655-1996-22/9.
DURING ATTEMPT TO TREAT PT, 64 YEAR OLD FEMALE, EMT HAD DIFFICULTY WITH    PADS. WHEN EMT WENT TO APPLY PADS THE PLASTIC COVER DID NOT WANT TO COME OFF AND STARTED TO TEAR PADS. THEY APPLIED ANOTHER SET OF PADS AND THE 2ND SET WORKED. THEY WERE THEN ABLE TO CONVERT THE PT SUCCESSFULLY.
GENERAL REPORT RECEIVED FROM THE PEDIATRIC ONCOLOGY UNIT INDICATING, "WHEN THE LOCKING BLUNT CANNULA IS CONNECTED TO THIS EXTENSION SET, THEY ARE PULLING APART." THE DISCONNECT OCCURS WHEN CHILDREN ARE ACTIVE AND PLAYING. NO DRUG SPILLAGE HAS COME IN CONTACT WITH THE PTS, HOWEVER, CLINICIAN IS  CONCERNED THAT A POTENTIAL SPILL ONTO A PT MAY OCCUR. THE NUMBER OF TIMES THE EVENT HAS OCCURRRED WAS NOT SPECIFIED. NO SPECIFIC EVENT DETAILS WERE PROVIDED.
THE DEVICE WAS RETURNED FOR ANALYSIS ON 8/26/96. TESTING IS NOT COMPLETED.
PT WAS FOUND BY STAFF NURSE IN BATHROOM WITH DOOR LOCKED. STAFF USED KEY AND ENTERED. PT WAS FOUND SLUMPED ON FLOOR WITH BUTTER KNIFE IN HAND AND PCA PUMP AT SIDE. PT WAS DIAPHORETIC; RESPONDED TO VERBAL COMMANDS, BUT LETHARGIC IN MOVEMENT. AFTER MOVING PT TO BED, PCA PUMP WAS INSPECTED AND TAMPERING WAS NOTED ON PUMP. 30CC DEMEROL LEFT IN PUMP WITH 25CC UNACCOUNTED FOR. PT WAS GIVEN NARCAN, PLACED ON TELEMETRY AND MONITORED CLOSELY. PT SHOWED NURSE THE NEXT DAY HOW HE HAD USED THE KNIFE TO GIVE HIMSELF A BOLUS INJECTION.
DURING SERVICE OF PRODUCT A POTENTIAL NO LOW PRESSURE ALARM CONDITION WAS FOUND DUE TO LIQUID IN PT PRESSURE TUBE. DEVICE RETURNED UNREPAIRED AT CUSTOMER'S REQUEST. MFR INFORMED CUSTOMER THAT IT DOES NOT RECOMMEND DEVICE FOR PT USE UNTIL PROPER REPAIRS HAVE BEEN PERFORMED BY AUTHORIZED PERSONNEL. MFR DISABLED DEVICE PRIOR TO RETURNING IT TO CUSTOMER.
SURGEON REMOVED A BIPOLAR LINER COMPONENT DUE TO DISLOCATION. ALSO WERE REMOVED WERE A BIPOLAR SHELL COMPONENT 85-8245, MDR REPORT #1219655-1996-0021, AND A FEMORAL HIP HEAD 85-3811, MDR REPORT# 1219655-1996-0009. THE DEVICE WERE IMPLANTED ON 7/10/96. REFERENCE # 1219655-1996-21/9.
H2-DIMENSIONAL INSPECTION OF RETURNED LINER COULD NOT BE PERFORMED AS DEVICE HAD BEEN AUTOCLAVED PRIOR TO RETURN TO JJPI. DIMENSIONAL ANALYSIS AND CANTILEVER TESTING OF 3 LINER COMPONENTS FROM THE SAME BATCH WERE FOUND TO MEET PRODUCT SPECIFICATION REQUIREMENTS. ADDITIONALLY, A REVIEW OF THE PRODUCTION BATCH RECORDS FOR THIS LOT FOUND DIMENSIONS TO HAVE MEET SPECIFICATION REQUIREMENTS. NO FURTHER INVESTIGATION IS PLANNED.
REPORT OF ALLEFED "WILL NOT RUN ON AC POWER. NO AUDIBLE OR VISUAL ALARMS FOUND DURING BENCH TESTING."
UNABLE TO OBTAIN INFO REQUIRED IN SECTION F. LABELING #1738. TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL. EVIDENCE OF LIQUID SPILL. DEVICE RETURNED UNREPAIRED AT CUSTOMER'S REQUEST. MFR INFORMED CUSTOMER THAT IT DOES NOT RECOMMEND DEVICE FOR PT USE UNTIL PROPER REPAIRS HAVE BEEN PERFORMED BY AUTHORIZED PERSONNEL. MFR DISABLED DEVICE PRIOR TO RETURNING IT TO CUSTOMER.
DURING A PT TREATMENT A BLOOD ALARM OCCLUDED WITH APPROPRIATE VISUAL AND AUDIBLE RESPONSE. THE MACHINE'S BLOOD PUMP APPROPRIATELY STOPPED, BUT THE VENOUS LINE OCCLUDING CLAMP DID NOT CLOSE AS EXPECTED. THE MACHINE HAD PASSED THE PRETREATMENT ALARM TESTS. PT INJURY IS NOT LIKELY TO OCCUR UNLESS THE OPERATOR OVERRIDES THE ALARM CONDITION. THE NURSE IMMEDIATELY CLAMPED THE PT'S BLOODLINES AND DISCONNECTED THE PT FROM THE EXTRACORPOREAL CIRCUIT. THE BLOOD WAS RECIRCULATED WHILE THE LEVEL DETECTOR MODULE WAS REPLACED, PROPER OPERATION VERIFIED AND THE TREATMENT RESTARTED. THERE WAS NO BLOOD LOSS AND NO PT INJURY. THE TREATMENT WAS COMPLETED WITHOUT INCIDENT.
LEAKAGE OF ADRIAMYCIN FROM THE SEAM OF THE FILTER OCCURRED DURING CLINICAL USE OF THE DEVICE. THE AGENT DRIPPED ONTO THE HAND OF THE PT CAUSING BURNING AT THE SITE. THE SITE WAS CLEANED AND DSMO APPLIED TOPICALLY. DSMO TREATMENT WAS CONTINUED Q6H FOR 2 DAYS AND NO SITE INJURY WAS APPARENT AT 2 DAYS OR AT ONE WK POSTINCIDENT.
THE DEVICE WAS DISCARDED AT THE UF BECAUSE THE PRESENCE OF AN ONCOLOGY AGENT IN AN IV SET PRECLUDES INVESTIGATION FUE TO POTENTIAL PERSONNEL HAZARD IN HANDLING THE SET.
PT WAS FOUND BY STAFF NURSE IN BATHROOM WITH DOOR LOCKED. THE PT REFUSED TO OPEN DOOR. STAFF USED KEY AND ENTERED. PT WAS FOUND SLUMPED ON FLOOR WITH BUTTER KNIFE IN HAND AND PCA PUMP AT SIDE. PT WAS DIAPHROETIC; RESPONDED TO VERBAL COMMANDS, BUT LETHARGIC IN MOVEMENT. AFTER MOVING PT. TO BED, PCA PUMP WAS INSPECTED AND TAMPERING WAS NOTED ON PUMP. 30 CC DEMEROL LEFT IN PUMP WITH 25CC UNACCOUNTED FOR. PT WAS GIVEN NARCAN, PLACED ON TELEMETRY AND MONITORED CLOSELY. PT SHOWED NURSE THE NEXT DAY HOW HE HAD USED THE KNIFE TO GIVE HIMSELF A BOLUS INJECTION. PT HISTORY INCLUDED PREVIOUS SUICIDE ATTEMPT. THE PUMP DID ALARM ALERTING THE STAFF TO CHECK THE PUMP.
EVALUATION: DEVICE WAS NOT RETURNED FOR EVALUATION. USER TAMPERING CAUSED THIS EVENT. INFO IN SECTION F. COMPLETED BY BAXTER. EVALUATION OF DEVICE RETURNED WAS REVIEWED BY ENGINEERING AND CONFIRMED THE ORIGINALLY REPORTED CONDITION. DAMAGE TO THIS PUMP WAS FURTHER DETERMINED TO BE CONSISTENT WITH TAMPERING.
THE VENTILATOR WENT INTO A SAFETY VALVE OPEN (SVO) MODE AND NO AUDIBLE ALARM SOUNDED. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. AS A PRECAUTION THE CSE REMOVED AND REPLACED THE CPU PRINTED CIRCUIT BOARD. THE UNIT PASSED EXTENDED SELF TESTING. THE REPORTED EVENT COULD NOT BE DUPLICATED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
FACILITY FOUND WHAT APPEARED TO BE SMALL BEADS OF SILICONE ON THE TIPS OF 2 LOTS OF FISTULA NEEDLES. ALSO NOTED THAT THE "EPOXY" RING THAT NORMALLY JOINS THE NEEDLE TO THE HUB WAS INCOMPLETE. IT APPEARED THAT IT WAS NOT COMPLETELY MOLDED ALL THE WAY AROUND. NO PT EVENTS HAVE OCCURRED THAT THE FACILITY IS AWARE OF.
THE TIPS OF THE TEFLON CATHETER HAVE "PEELED BACK" UPON INSERTION INTO THE PTS. THIS HAS OCCURRED ON TWO DIFFERENT PTS USING THE SAME LOT NUMBER. OTHER LOTS FROM MFR ARE FINE. IF A PIECE OF THE TEFLON CATHETER BREAKS LOOSE, IT POSES A SERIOUS HEALTH RISK TO THE PT. CATHETER AND NEEDLE UNITS FROM THIS LOT HAVE BEEN SUSPENDED FROM USE.
THERE WAS NO AUDIBLE ALARM. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTEDTHE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF TESTING. THE CSE REPLACED THE AUDIO ALARM AS A PRECAUTION. IT IS NOT VERIFIED THAT THE ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
EVALUATION OF THE REPLACED COMPONENTS INDICATED THE PIEZO-ELECTRIC DISK WAS NOT PROPERLY CENTERED IN ITS HOUSING. THIS IS KNOWN TO AFFECT OPERATION OF THE ALARM. A CORRECTIVE ACTION OF A NEW PART QUALIFICATION HAS BEEN   PERFORMED TO ADDRESS THIS ISSUE.
A PT LOST AN EXCESS OF 3.9 KG. OF FLUID DURING A DIALYSIS TREATMENT. THE MACHINE PASSED THE RECOMMENDED PRETREATMENT TESTING. THIRTY MINUTES INTO THE TREATMENT THE BLOOD IN THE EXTRACORPOREAL CIRCUIT APPEARED DARK. THE VENOUS AND TMP PRESSURES ROSE TO THE HIGH END OF THE MONITORS AND ALARMED. THE FACILITY STATED THE TMP LIMITS WERE SET AT +/-50MMHG. THE PT WAS ASYMPTOMATIC. THE TREATMENT WAS DISCONTINUED WITHOUT RETURNING THE PT'S BLOOD AND THE BLOOD WAS RECIRCULATED IN THE EXTRACORPOREAL CIRCUIT. THE BLOOD CLOTTED AND WAS DISCARDED (APPROX 230ML). A NEW DIALYZER WAS PREPARED AND THE TREATMENT RESTARTED. THE BLOOD STILL APPEARED DARK, THEREFORE ACCESS RECIRCULATION WAS SUSPECTED. A NEW NEEDLE WAS PLACED AND THE TREATMENT CONTINUED. THE BLOOD AGAIN APPEARED DARK, THE TMP AND VENOUS PRESSURES ALARMED. THE PT WAS HYPOTENSIVE, NORMAL SALINE GIVEN AND THE TREATMENT DISCONTINUED.
THE PT'S BLOOD PRESSURE RESPONDED TO NORMAL SALINE. THE PT HAD NO ADD'L SYMPTOMS. THE MACHINE WAS REMOVED FROM THE TREATMENT AREA FOR SERVICE BY THE MFR. A BROKEN SPRING AND UF CHECK VALVE WERE REPLACED AND THE UF PUMP REBUILT. PROPER MACHINE OPERATION WAS VERIFIED.
SEVEN DAY INFUSOR STOPPED INFUSING 3 DAYS INTO INFUSION.
WHILE SETTING UP THE VENTILATOR FOR TESTING THERE WAS NO AUDIO ALARM. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE CSE REPLACED THE POWER SWITCH AS A PRECAUTION. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
CATHETER STICKS ON NEEDLE. CANNOT REMOVE NEEDLE WITHOUT TRAUMA TO SKIN OR VESSEL.
THE PULSE MODE NEEDED TO BE CHECKED OUT AND RETURNED THE VENTILATOR FOR CO'S EVALUATION. DURING FUNCTIONAL TEST, ENOUGH LIQUID OXYGEN LEAKED OUT OF THE RUPTURED DIAPHRAGM IN THE RELIEF ECONOMIZER VALVE TO POTENTIALLY CAUSE A SERIOUS INJURY IF THIS EVENT WERE TO RECUR. ADDITIONALLY, CO'S SERVICE TECH REPORTED THAT THE PNEUMATIC DEMAND DEVICE WAS OUT OF SPECIFICATION (WHICH DUPLICATED THE REPORTED PROBLEM), THE FLOW CONTROL KNOB, FLOW INDICATOR, AND CONNECTING TUBES WERE CRACKED, THE OXYGEN BARB WAS BENT, AND THE IN-LINE FILTER WAS DAMAGED. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. A CORRECTIVE ACTION FOR THE RELIEF ECONOMIZER VALVE WAS IMPLEMENTED FOR UNITS MFG AFTER 11/22/94 WHICH REPLACED THE DIAPHRAGM WITH A MORE DURABLE MATERIAL. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MFG PROCESS PER THE APPROVED DMR.
THE AUDIBLE ALARM DID NOT ACTIVATE. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE, BUT WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM AND REPLACED THE MAIN POWER SWITCH AND PERFORMED AN ADJUSTMENT TO THE BATTERY TERMINALS. BOTH SERVICES WERE PERFORMED AS A PRECAUTION. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE AUDIO ALARM DID NOT SOUND, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
BLOCK F IS COMPLETED BY MFR. SYMPTOMS ARE ADDRESSED IN THE DEVICE LABELING. THE DEVICE LABELING RECOMMENDS THAT PRETREATMNET PRESSURE TESTING IS PERFORMED BEFORE EACH DIALYSIS USING A HIGH PERMEABLE MEMBRANE. THE INVESTIGATION SHOWED THIS PRETREATMENT PRESSURE TESTING WOULD NOT PASS WITH THE VALVE LEAKING.
SINCE SURGERY TO IMPLANT THE PEDICLE SCREWS AND RODS (STAINLESS STEEL) RPTR HAS BEEN EXPERIENCING EXTREME PAIN, ITCHING AND ACIDLIKE BURNING. AS TIME PROGRESSED ALL OF THE SYMPTOMS ARE WORSENING. RPTR ALSO HAS CONTINUOUS TRANSIENT SWELLING, INFLAMMATION AND DECREASING MOTOR ABILITY (WALKING). ASTHMA HAS INCREASINGLY WORSENED. ALSO CONTINUOUS INFECTIONS AND HORMONAL PROBLEMS. MD AND REPORTER REQUESTED REMOVAL BUT WAS REFUSED BY INSURER. DATE OF EVENT 2/23/95 - PRESENT.
DURING A SALES DEMONSTRATION OF HOW THE SAFETY SYRINGE WORKS, THE PRODUCT SPECIALIST SLAMMED THE LOCKED SHIELD AGAINST HIS PALM TO DEMONSTRATE ITS EFFECTIVENESS. THE NEEDLE IMPALED HIS PALM EXITING FROM THE OTHER SIDE, LEAVING ONLY A PINPOINT OF BLOOD THAT HEALED QUICKLY. THE PRODUCT SPECIALIST THEN WASHED HIS HANDS AND NO MEDICAL TREATMENT WAS NECESSARY, NO COMPLICATIONS DEVELOPED. THE PRODUCT SPECIALIST STATES THAT THE SHIELD WAS TURNING LOOSE AROUND THE SAFETY COLLAR, NOT IN THE LOCKED POSITION.
ACTUAL DEVICE WAS RETURNED AND EVALUATED. ANALYSIS REVEALED THE SYRINGE HAD BEEN SUBJECTED TO SEVERE AND REPEATED ABUSE. THE SHIELD HAD BEEN FORCED TO RETRACT FROM THE LOCKED POSITION AND WAS TORQUED IN BOTH THE CLOCKWISE AND COUNTER-CLOCKWISE DIRECTION CAUSING THE SHIELD TO SPIN ABOUT THE COLLAR. IT WAS CONCLUDED THAT THE SYRINGE WAS USED IN A MANNER NOT INTENDED DURING THE DEMONSTRATION BY THE PRODUCT SPECIALIST.
NO EKG DISPLAY ON MONITOR. PT CABLE AND EKG MODULE CHANGED, BUT PROBLEM NOT CORRECTED. ELECTRODES CHANGED X3, BUT STILL NO EKG. REPLACED ELECTRODES WITH ANOTHER BRAND AND PROBLEM CORRECTED.
THE AUDIBLE ALARM WAS NOT WORKING. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND FOUND THE POWER CORD AND GROMMET UNSECURED WITH ONE OF THE CONNECTIONS TO THE POWER SWITCH LOOSE. THE CSE REPLACED THE POWER SWITCH AS A PRECAUTION, AND RECONNECTED THE POWER CORD AND GROMMET. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURED A A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
TIP OF RESECTOSCOPE INNER SHEATH SEPARATED IN PT. RETRIEVED WITH FORCEPS. THIS WAS THE SECOND INCIDENT AT THIS HOSP (THE FIRST OF ON 5/15/96).
PROBLEM MOST LIKELY OCCURRED DUE TO IMPROPER ASSEMBLY OR DISASSEMBLY OF THE CFR INNER AND OUTER SHEATHS. A LATERAL FORCE OF 3.2 LBS. APPLIED TO THE RESECTOSCOPE HANDLE, WHEN ONLY THE INNER SHEATH TIP IS IN THE OUTER SHEATH, WILL APPLY A RESULTANT FORCE OF 70.4 TO THE INNER SHEATH TIP. THIS IS SUFFICIENT FORCE TO FRACTURE THE SHEATH TIP.
PER REPORTER IF FOLDING PROBLEM WERE TO RECUR IT COULD RESULT IN PT INJURY. NO PT INJURY WAS REPORTED WITH THIS EXPERIENCE.
NO ADD'L INFO HAS BEEN RECEIVED FROM REPORTER DESPITE REQUEST. THE RETURNED LENS WAS EVALUATED AND A TECH WAS ABLE TO FOLD THE LENS. THE LENS MET ALL RELEASE CRITERIA. THE MFR'S INTERNAL REFERENCE NUMBER IS 96L4239. THIS REPORT WAS MAILED IN TO FDA ON: 09/25/96. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
OVERDELIVERY REPORTED. THE PCA PUMP WAS TO ADMINISTER MORPHINE ANALGESIA WITH ORDERED SETTINGS OF: MORPHINE 1 MG/ML, PCA PLUS CONTINUOUS MODE, PCA DOSE OF 1 MG WITH A PT LOCKOUT INTERVAL OF 6 MINUTES, 2 MG/HR CONTINUOUS, NO 4 HOUR LIMIT SET. A 30 ML (30 MG) SYRINGE WAS STARTED AT 9:30AM. AT 10:46AM THE DEVICE ALARMED FOR AN EMPTY SYRINGE. THE REPORTER INDICATED THAT THE "DOSE WAS 1.0 MG BUT THE MACHINE WAS SET AT 0.5 MG." THE PARAMETER THAT WAS MISPROGRAMMED WAS NOT SPECIFIED. THE NUMBER OF PT BOLUSES REQUESTED WAS NOT AVAILABLE. CONTACT WITH RISK MANAGEMENT COULD NOT CLARIFY IF THE CONCENTRATION OR THE PCA DOSE WAS SET INCORRECTLY, "THE STAFF MEMBER COULD NOT RECALL." THE PT WAS "SLEEPY BUT OK." THERE WAS NO REPORT OF ANY CHANGE IN HER RESPIRATORY STATUS OR VITAL SIGNS. NO MEDICAL INTERVENTION WAS REQUIRED. THE PCA INFUSION WAS DISCONTINUED.
THE REPORTED PROBLEM COULD NOT BE DUPLICATED DURING TESTING SPECIFICATION AS PROGRAMMED. OBSERVATIONS OUT OF SPECIFICATION INCLUDE OCCLUSION PRESSURE, DEFECTIVE PATIENT PENDANT AND POWER CORD. THESE FINDINGS ARE NOT LIKELY TO RELATE TO OVERINFUSION REPORT. FREQUENCY OF OCCURRENCE OF OVERDELIVERY FOR THE PCA FAMILY IS APPROXIMATELY 3.33/MILLION SETS.
THE CUSTOMER ALLEGED THE VOLUME ON THE AUDIBLE ALARM WOULD CHANGE WHEN ONE OF THE ALARM'S WIRE WAS MOVED. THE AUDIBLE ALARM ASSEMBLY WAS REMOVED AND REPLACED AS A PRECAUTION. IT HAS NOT BEEN VERIFIED THAT THE UNIT'S ALARM EVER FAILED TO SOUND, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
NO ADD'L INFO HAS BEEN RECEIVED FROM REPORTER DESPITE REQUEST. THE RETURNED LENS WAS EVALUATED AND NO DEFECTS WERE OBSERVED. THE MFR'S INTERNAL REFERENCE NUMBER IS 96L4240. THIS REPORT WAS MAILED IN TO FDA ON: 09/25/96. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SEROIS INJURY.
THE I/A TUBE SET LEAKED DURING PHACO EYE SURGERY.
UNIT IS BEING SENT TO CONTRACT MFR FOR ADD'L REVIEW AND EVALUATION. A SECOND BACKUP PACK WAS USED TO COMPLETE SURGERY. NO PT INJURY WAS ASSOCIATED WITH THIS EVENT. EVALUATION SUMMARY: FUNCTIONAL TESTING: THE TUBING WAS TESTED; BLUE DYE DELIVERED INTO THE TUBING BY A SQUEEZE BOTTLE. NO LEAKS WERE DETECTED IN THE TUBING. THE TUBING WAS THEN CONNECTED TO A SURGICAL SYSTEM TO SIMULATE OPERATING CONDITIONS. DURING THIS TEST A LEAK WAS DISCOVERED AT ONE OF THE TUBING CONNECTORS. NO CRACKS, SPLITS, OR DEFECTS WERE OBSERVABLE; IT APPEARS THAT THE CONNECTOR WAS NOT SUFFICIENTLY BONDING TO THE TUBING.
THE 5FR SELECTOR CATHETERS HAVE AN UNACCEPTABLE HIGH INCIDENCE OF MICRO-BUBBLE FORMATION DURING ASPIRATION AND FLUSHING OF THE CATHETER. CATHETERS CANNOT SAFELY BE USED DUE TO RISK OF AIR EMBOLIZATION TO THE BRAIN OR PERIPHERAL CIRCULATION. (*)
DURING SERVICE OF PRODUCT A CONTINUOUS CYCLE, NO VOLUME DELIVERED, WITH AUDIBLE AND VISUAL ALARMS WAS FOUND, DUE TO FIRST STAGE GEAR AND SOLENOID BEING OUT OF SPECIFICATION. DEVICE RETURNED UNREPAIRED AT CUSTOMER'S REQUEST. MFR INFORMED CUSTOMER THAT IT DOES NOT RECOMMEND DEVICE FOR PT USE UNTIL PROPER REPAIRS HAVE BEEN PERFORMED BY AUTHORIZED PERSONNEL. MFR DISABLED DEVICE PRIOR TO RETURNING IT TO CUSTOMER.
THE LASER CONTINUED TO LASE AFTER THE PHYSICIAN REMOVED HIS FOOT FROM THE FOOT PEDAL. REPORTER STATED THAT, APPROX 30 TO 45 MINUTES INTO A UROLOGICAL PROCEDURE (AT WHICH TIME THE LASER HAD BEEN USED INTERMITTENTLY FOR APPROX 650 JOULES). THE PHYSICIAN RELEASED THE FOOT PEDAL AND THE LASER CONTINUED TO LASE (AS EVIDENCED BY THE AUDIBLE SOUND AND THE LASING LIGHT "ON"). THE REPORTER DID NOT NOTICE IF THE LASER COUNTER CONTINUED OR WHETHER THE DISPLAY PANEL HAD READOUT "LASER SYSTEM ON". REPORTER THEN HIT STANDBY MODE, LASER CONTINUED TO LASE, SO SHE IMMEDIATELY DEPRESSED THE EMERGENCY SHUT OFF BUTTON. REPORTER PROCEEDED TO CHECK FOOT PEDAL BY REMOVING THE PLASTIC COVERING AND CHECKING IT MECHANICALLY BY PULLING UP ON THE FOOT PEDAL (SHE DID NOT DEPRESS THE PEDAL). AT THIS TIME, THE REPORTER DID NOT NOTE ANYTHING UNUSUAL. THE LASER WAS THEN TURNED BACK ON AND THE LASER IMMEDIATELY ALARMED AND THE LASING LIGHT WAS "ON" INDICATING THAT IT WAS LASING. THE EMERGENCY SHUT OFF BUTTON WAS IMMEDIATELY DEPRESSED. THE TECHNICIAN THEN PROCEEDED TO RESTART THE LASER AND, USING A TEST FIBER, EVERYTHING APPEARED TO BE IN WORKING ORDER. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT AND NO INJURIES WERE REPORTED.
THE FIELD SERVICE ENGINEER CONCLUDED THAT THE FOOTSWITCH HAD MECHANICALLY STUCK IN THE "ON" POSITION. FURTHER EVALUATION OF THE FOOTSWITCH REVEALED THAT THE TENSION ON THE LEVER FELT LESS THAN NORMAL. IT WAS ALSO NOTED THAT THE LEVER HINGE PIN APPEARED TO BE PROTRUDING OUT OF THE HOUSING APPROXIMATELY 1/8 INCH, WHICH IS NOT NORMAL. DURING EVALUATION OF THE FOOTSWITCH, THE FIELD SERVICE ENGINEER IDENTIFIED OTHER UNRELATED LASER COMPONENTS THAT REQUIRED SERVICE AND THE LASER AND FOOTSWITCH WERE RETURNED TO CO. UPON RECEIPT OF THE LASER AND FOOTSWITCH, THE LASER WAS REPAIRED AND THEN TESTED WITH THE REPORTED FOOTSWITCH. THE EVENT DID NOT RECUR. A FOOTSWITCH KNOWN TO FUNCTION PROPERLY WAS ADJUSTED MANUALLY TO RECREATE THE LEVER HINGE PROTRUSION CONDITION DESCRIBED ABOVE. THE MALFUNCTION DID NOT RECUR WHEN THIS FOOTSWITCH WAS USED WITH A LASER SYSTEM KNOWN TO PERFORM WITHIN SPECIFICATIONS. TWO ADDITIONAL POSSIBILITIES FOR FOOTSWITCH FAILRE WERE CONSIDERED: 1) THE FOOTSWITCH HAD A FOREIGN OBJECT JAMMED BETWEEN THE SPRING RELIEF ON THE BOTTOM OF THE FOOT PEDAL AND PUSH ROD, AND, 2) A MICROSWITCH MALFUNCTIONED IN CIRCUITRY. CO QUALITY ENGINEERING CONFERRED WITH THE MFR OF THE FOOTSWITCH AND FOUND THAT THE MEAN TIME BETWEEN FAILURE RATE ON THE MICROSWITCHES USED IN THE FOOTSWITCH IS A MILLION AND A HALF CYCLES. BASED ON THAT INFORMATION, IT IS UNLIKELY THAT THE MICROSWITCH WAS THE CAUSE OF THE FAILURE. UPON FURTHER DISCUSSION WITH THE FIELD SERVICE ENGINEER, IT IS MOST LIKELY A FOREIGN OBJECT CONTRIBUTED TO THE FAILURE.
INTERMITTENT LOSS OF VENTRICULAR SENSING WAS OBSERVED.
REFERENCE SECTION F.190 OFTHIS FORM FOR THE EVENT PROBLEM CODES.
DURING PTCA THE BALLOON WOULD NOT DEFLATE. THE INFLATION DEVICE WAS REMOVED AND A SYRINGE WAS ATTACHED TO SUCCESSFULLY DEFLATE THE BALLOON. AFTER DEVICE REMOVAL FROM THE PT, IT WAS NOTED THAT THE SHAFT OF THE CATHETER HAD FRACTURED INTO TWO PIECES. NO PT INJURY WAS REPORTED ASSOCIATED WITH THIS INCIDENT.
EVAL SUMMARY: THE DEVICE WAS REC'D FOR EVAL ON 9/4/96. ANALYSIS VERIFIED THE HYPOTUBE SEPARATION AND ALSO FOUND THE BALLOON HAD BEEN RADIALLY DISSECTED THREE QUARTERS OF THE CIRCUMFERENCE OF THE BALLOON. QUALITY ENGINEERING HAS DETERMINED THAT IT IS LIKELY THAT THE SEPARATION MAY HAVE BEEN CAUSED BY EXTREME BENDING OR MANIPULATION DURING ADVANCEMENT OF THE CATHETER. THESE CONDITIONS CAN RESULT IN POOR DEFLATION OF THE BALLOON.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
9/26/96 MEDWATCH REPORT NOT RECIEVED BY MFR. SUBMITTED INITITAL REPORT.
PRIOR TO APPLICATION FOR A VATS PROCEDURE, THE DEVICE WAS TESTED AND THE JAWS WOULD NOT OPEN. THE STAPLER WAS NOT USED. WHEN TESTED AFTERWARDS, THE JAWS OPENED WITHOUT DIFFICULTY.
9/26/96 -MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
DURING PTCA OF A TORTUOUS LESION LOCATED IN THE PT'S LEFT CIRCUMFLEX, THE BALLOON REMAINED INFLATED FOR 90 SECONDS. THE PT DID NOT EXPERIENCE ANY ST CHANGES DURING THIS TIME. THE BALLOON WAS SUCCESSFULLY DEFLATED AND WAS REMOVED FROM THE PT. THE PHYSICIAN OPTED FOR PLACING ANOTHER DILATATION CATHETER (REF MFR RPT #2024168-1996-00010) INSIDE THE PT FOR FURTHER INFLATION TO OPTIMIZE THE RESULT OF THE PTCA. AFTER FURTHER INFLATION WITH THE SECOND BALLOON CATHETER, A DISSECTION WAS NOTED. THE BALLOON DEFLATION TIME ON THE SECOND CATHETER WAS REPORTED TO BE 58 SECONDS. THE DEVICE WAS REMOVED FROM THE PT AND THE DISSECTION WAS SUCCESSFULLY TACKED WITH ANOTHER BALLOON CATHETER. THE PT IS REPORTED AS FINE.
NO PT INJURY OCCURRED, BUT NOTED I/A GRINDING NOISE AND SHALLOWING OF CHAMBER; RESIDUAL VACUUM.
A CO SERVICE REP CHECKED THE UNIT AND FOUND IT TO MEET ITS PERFORMANCE SPECIFICATIONS. THIS REPORT SUBMITTED TO FDA ON 9/25/96. THE MFR'S INTERNAL REFERENCE NUMBER IS 9-8885-96. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
DURING TURP, THE TIP OF THE RESECTOSCOPE SHEATH REPORTEDLY SEPARATED, REQUIRING REMOVAL FROM PT'S BLADDER. DURING REMOVAL THERE WAS A SMALL LACERATION TO PT'S URETHRA.
DATE OF INCIDENT WAS 7/19/95 (NOT 7/13/95 AS ORIGINALLY REPORTED).
THERE WAS NO AUDIO ALARM. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF TESTING. NO PARTS WERE REPLACED. IT IS NOT VERIFIED THAT THE ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE DEVICE DISCONNECTED AND LEAKED DURING USE.
ONE UNIT RETURNED TO CO FOR EVALUATION. EXAMINATION OF THE TUBING HAD NOT BEEN SOLVENT BONDED. PRODUCTION HAS BEEN NOTIFIED. THE LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEUDRE. REPORTEDLY, THE ANCHOR BLOCKS BROKE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
AUDIBLE ALARM FAULTY. THE CUSTOMER SERVICE ENGINEER (CSE) INSPECTED THE DEVICE AND DETERMINED THAT THE WIRES LEADING FROM THE ALARM ASSEMBLY WERE DAMAGED. THE CSE REMOVED AND REPLACED THE ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. IT WAS NOT VERIFIED THAT THE ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE DEVICE CRACKED AND LEAKED DURING SET UP.
EXAMINATION OF THE RETURNED UNIT WAS UNABLE TO CONFIRM THE ISSUE OF THE UNIT BEING CRACKED AND LEAKING. NO DEFECTS WERE FOUND WITH THE RETURNED UNIT. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
PERFORATION OF ARTERIAL J LEAD DEMONSTRATED BY FLUORO; CT NOTED HEMOPERICARDIUM. J-WIRE (RETENTION WIRE) 3 1/4" IN LENGTH DISLODGED FROM ATRIAL LEAD AND PERFORATED RF FREE WALL. REMOVED WITH GOOSENECK SNARE THROUGH MULLINS TRANSEPTAL SHEATH. NO SEQUELAE.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUANTITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE MALE LUER DISCONNECTED DURING THE PROCEDURE. THE REPORTER INDICATED THAT THIS HAD OCCURRED ON 5 OTHER OCCASIONS BUT DID NOT PROVIDE SPECIFIC DETAILS.
THIS ISSUE IS A MOLDING DEFECT ASSOCIATED WITH THE IMPROPER PLACEMENT OF THE CORE PIN. THIS ISSUE HAS BEEN RESOLVED AND A QUALITY CONTROL TEST HAS BEEN IMPLEMENTED TO DEFECT THIS ISSUE. THE LOT HISTORY BL9-13-94 WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSITED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE SAFETY SHIELD DID NOT RETRACT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS RPEORTED THAT NO PT INJURY OCCURRED.
9/26/96 -MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INTIAL REPORT.
THE PUMP DELIVERED AT 6 ML/HR WHILE BEING PROGRAMMED AT 7 AND 8 ML/HR. NO PT INJURY WAS REPORTED. NO ADD'L SPECIFIC INFO WAS REC'D.
SECTION F COMPLETED BY THE MFR. EVAL RESULTS: FLOW ACCURACY TESTING WAS PERFORMED ON THE DEVICE AND THE RESULTS WERE WITHIN SPEC.
NON-DELIVERY OF SECONDARY MEDICATION REPORTED. THE PUMP WAS SET TO INFUSE AN UNSPECIFIED HYDRATION FLUID VIA PRIMARY LINE, AND A PRONESTYL DRIP AT 7 ML/HR VIA SECONDARY LINE. AFTER AN UNSPECIFIED AMOUNT OF TIME, A NURSE NOTED THE PRONESTYL WAS NOT INFUSING. SHE REPORTED THAT THE SECONDARY CONTAINER WAS HUNG BEHIND THE PRIMARY CONTAINER AND SHE COULD NOT INITIALLY OBSERVE THAT IT WAS NOT INFUSING. THE DISPLAY REGISTERED AS IF DELIVERY OCCURRED AND INDICATED 168 ML HAD INFUSED ON THE SECONDARY LINE. WHEN THE NON-DELIVERY WAS NOTED, THE PT REQUIRED A PRONESTYL BOLUS AND THE INFUSION WAS RE-STARTED WITH A NEW PUMP. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.
THE REPORTED PROBLEM COULD NO DUPLICATED. FREQUENCY OF DEATH OR SERIOUS INJURY CODE 103 (UNDERDELIVERY) FOR DEVICE IS APPROX. 0.05/MILLION SETS.
PENILE PROSTHESIS IMPLANTED ONE YEAR AGO. AT THIS TIME, THE PROSTHESIS SPONTANEOUSLY DEFLATES AT INAPPROPRIATE MOMENTS. ALSO HAS NOTED SOME ANGULATION OF THE PENIS AND SOME DISCOMFORT IN THE SCROTUM. PROSTHESIS DEFLATION DOCUMENTED: SIGNIFICANT DEFLATION OVER A 10 MIN PERIOD.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETED THE PROCEDURE.
SECTION A-F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
THE REPORTER STATED THE PRODUCT LEAKED DURING USE. REPORTED BY DISTRIBUTOR. EVENT OCCURRED AT AN UNKNOWN FACILITY.
ONE UNIT RETURNED FOR EVALUATION. EXAMINATION SHOWED THAT THE TUBING HAD NOT BEEN SOLVENT BONDED TO THE LUER LOCK. THIS COMPONENT IS ASSEMBLED BY MACHINERY. MAINTENANCE HAS BEEN NOTIFIED AND TAKING CORRECTIVE ACTION. LOT HISTORY REVIEW NOT AVAILABLE AS THE LOT NUMBER IS UNKNOWN TO THE CUSTOMER.
THE INFUSION PUMP WAS RECEIVED AT THE SVC FACILITY WITH A VAGUE REPORT THAT THE PUMP WAS ON A PT AND THE DEVICE WAS "NOT PUMPING THE CORRECT AMOUNT". NO ADD'L INFO WAS REC'D. NO PT INJURY RESULTED.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY FLOW ACCURACY TESTING WAS PREFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPEC.
THE DEVICE CRACKED ALLOWING BLOOD TO INFILTRATE INTO THE TUBING.
ONE UNIT WAS RETURNED TO CO FOR EVALUATION. EXAMINATION OF THE RETURNED UNIT SHOWED THAT THE MALE LUER WAS BROKEN OFF AND PART OF THE COLLAR WAS MISSING. IT APPEARS THAT THE HEALTHCARE PROVIDER USED EXCESSIVE FORCE WHICH MAY HAVE RESULTED IN THE FAILURE. VISUAL EXAM REVEALED HEMOSTASIS WERE USED IN CONJUNCTION WITH THIS DEVICE. LOT HISTORY REVIEW WAS NOT AVAILABLE AS THE LOT NUMBER IS UNKNOWN TO THE CUSTOMER.
RUPTURED L BRESAT IMPLANT. INTACT R BREAST IMPLANT.
THE INFUSION PUMP WAS REC'D AT THE SVC FACILITY WITH A VAGUE REPORT THAT IT WAS USED ON A PT AND THE ADD'L DEVICE WAS "NOT PUMPING THE CORRECT AMOUNT." NO ADD'L CLINICAL INFO WAS ABLE TO BE REC'D. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY FLOW ACCURACY WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPEC.
REPORT RECEIVED FROM CO'S AFFILIATE THAT STATES: "USER INFORMS THE PUMP INFUSES FASTER THAN PROGRAMMED. NO SIDE EFFECT HAS BEEN EXPERIENCED/REPORTED." NO FURTHER INFO IS AVAILABLE.
THE REPORTED PROBLEM COULD NOT BE DUPLICATED DURING TESTING AT THE FOREIGN SERVICE CENTER. THERE IS NO STATISTICAL INCREASE IN OVERDELIVERY REPORTS FOR THE PRODUCT LINE FOR THE LAST 12 MONTHS. COMPLAINT RATE FOR OVERDELIVERY FOR LIFECARE PRODUCT LINE IS APPROX. 0.32/MILLION SETS.
CATHETER BALLOON RUPTURED DURING ATRIAL SEPTOSTOMY.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE AN UNSPECIFIED CONCENTRATION OF FETANYL AT 14 ML/HR. A NURSE STARTED A 250 ML CONTAINER AT 3:00PM AND AT 11:00PM IT WAS EMPTY. THE DISPLAY SCREEN INDICATED DELIVERY OF 120 ML. THE EXPECTED DELIVERY WAS APPROX 112 ML. THE PT BECAME SOMNOLENT AND RECEIVED NARCAN. HE SUBSEQUENTLY "RECOVERED AND IS OK NOW." NO ADVERSE SEQUELAE REPORTED. FURTHER INFO WAS REQUESTED BUT NOT PROVIDED.
RISK MGR PREFERRED THIRD PARTY TESTING OF THE PUMP TO BE COMPLETED AND  ELECTED NOT TO SEND THE DEVICE TO CO FOR EVALUATION. IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED TO CO AFTER THE THIRD PARTY TESTING IS COMPLETE.
DURING A CATARACT EXTRACTION PROCEDURE, THIS BIPOLAR CORD WOULD NOT WORK. ANOTHER CORD WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS 1-4 WERE COMPLATED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
BILATERAL CAPSULECTOMY WITH REMOVAL OF RUPTURED BREAST IMPLANT.
THE SCREWS ON THE BACKPLATE OF THE DISPOSABLE BLOOD PUMP WERE LOOSE AND QUESTIONED WHETHER THE VALVES WERE FUNCTIONING CORRECTLY. THE BLOOD PUMP WAS RETURNED TO CO AND EVALUATED. THE SCREW PROBLEM WAS CONFIRMED. THE VALVES WERE FOUND TO BE FUNCTIONING SATISFACTORILY.
THE INFUSION PUMP WAS REC'D AT THE SVC FACILITY WITH A VAGUE REPORT THAT THE PUMP WAS USED ON A PT AND IT WAS "NOT INFUSING THE CORRECT AMOUNT". NO ADD'L CLINICAL INFO WAS RECEIVED. NO PT INJURY WAS REPORTED.
CAPSULECTOMY WITH REMOVAL OF BILATERAL IMPLANTS.
UNDERDELIVERY REPORTED. THE PUMP INITIALLY WAS GIVING AIR-IN-LINE ALARMS THAT WERE RESOLVED. AFTER INFUSING APPROPRIATELY FOR AN UNSPECIFIED AMOUNT OF TIME, THE PUMP GAVE A SYSTEM ERROR ALARM. IT TOO WAS RESOLVED AND THE BATTERIES WERE CHANGED. THE PUMP WAS SET TO INFUSE ZOFRAN AT 1 ML/HR. PRIOR TO THE SYSTEM ALARM THE DISPLAY INDICATED DELIVERY OF 10.4 ML HAD OCCURRED. APPROX. 2 HOURS LATER, THE PUMP APPEARED TO BE INFUSING BUT THE DISPLAY HAD ONLY INCREMENTED TO 10.5 ML DELIVERED. THE INFUSION WAS THEN DISCONTINUED DUE TO IMPROVED PT STATUS (HIS NAUSEA HAD SUBSIDED). THE EVENT DID NOT CAUSE ANY ADVERSE PT EFFECTS.
THE DEVICE WAS RECEIVED FOR ANALYSIS ON 9/10/96. TESTING IS NOT COMPLETE.
DURING PT SUPPORT, THE CONSOLE STARTED ALARMING "FOOT PUMP HANDLE DISLODGED". THE CONSOLE CONTINUED TO PUMP NORMALLY AND THERE WAS NO IMPACT ON THE PT. THE CONSOLE WILL BE EVALUATED.
NOT IN LABELING NOT OCCURRING AT GREATER FREQUENCY OR SEVERITY.
VACUUM TUBE WAS SEPARATED FROM THE ONE-WAY VALVE WHEN THE DEVICE WAS CONNECTED TO THE VACUUM TUBE ASSEMBLY. IT WAS REPLACED BY ANOTHER PRODUCT AND THE PT HAS NO PROBLEMS.
SECTIONS A-F WERE COMPLETED BY MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE PCA 10 MG/ML. THE PCA DOSE WAS 10 MG (1 ML). COMPLETE SETTINGS WERE NOT SPECIFIED. AT 1:40AM, AFTER THE FIRST REQUESTED BOLUS DELIVERY, THE NURSE NOTED 3 ML WERE GONE FROM THE SYRINGE. EXPECTED DELIVERY VOLUME WAS 1 ML. SHE INSTRUCTED THE PT TO CALL FOR HER PRIOR TO THE NEXT REQUESTED BOLUS. THE NURSE OBSERVED THE SECOND DELIVERY AND NOTED THAT THE 2 ML WERE ADMINISTERED. THE SETTINGS WERE DOUBLE CHECKED WITH THE NURSING SUPERVISOR AND NOTED TO BE CORRECT. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THE MEPERIDINE. THE PUMP WAS SWITCHED OUT, AND THE NEW PUMP DELIVERED AS EXPECTED.
THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE DEVICE PASSED DELIVERY ACCURACY TESTING WITHIN PRODUCT SPECIFICATION. UNRELATED FINDINGS IDENTIFIED DURING TESTING. BUT THESE ARE NOT LIKELY TO HAVE RESULTED IN OVERDELIVERY. FREQUENCY OF OCCURRENCE OF OVERDELIVERY FOR PCA FAMILY IS APPROXIMATELY 3.33/MILLION SETS.
DRAINAGE TUBE GOING INTO PT FELL OFF DURING RE-INFUSION.
THE DEVICE WAS APPLIED DURING A NISSEN FUNDOPLICATION. REPORTEDLY, THE TIP WOULD NOT RETURN TO THE NORMAL POSITION AFTER ARTICULATING. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE AN UNSPECIFIED HYDRATION SOLUTION AT 100 ML/HR. A 1000 M; IV CONTAINER WAS STARTED AT 3:35AM, AND AT 5:00 AM THERE WAS 550 ML REMAINING. THE INFUSION WAS CONTINUED, AND BY 7:00AM THE CONTAINER WAS EMPTY. THE PT TOLERATED THE INFUSION WELL AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS. HE HAD BEEN ADMITTED FOR 23 HOUR OBSERVATION WITH IV DELIVERY, AND HE WAS DISCHARGED AS ANTICIPATED WITHOUT ANY DELAY.
THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THERE HAVE BEEN NO DEATH OR SERIOUS INJURY CODE 103 (OVERDELIVERY) REPORTS FOR THE LAST 12 MONTHS FOR THIS LIST NUMBER.
TWO RN'S WERE INSERTING THE P.I.C. CATHETER VIA THE LEFT CEPHALIC VEIN. AT APPROX 35 CM, RESISTANCE WAS FELT. THE FIRST RN IMMEDIATELY STOPPED PASSING THE CATHETER. THE SECOND RN TOOK OVER THE PROCEDURE AND THE CATHETER "BOUNCED BACK" APPROX 1.5 CM AT THE TIME OF THE EXCHANGE. THE SECOND RN ATTEMPTED TO REMOVE THE CATHETER, INTRODUCER AND GUIDEWIRE SIMULTANEOUSLY. AT THAT POINT IT WAS APPARENT THAT THE CATHETER WAS SEVERED. TOURNIQUET WAS APPLIED TO ARM AT AXILLA AND PT TAKEN IMMEDIATELY TO THE ER. SHOULDER X-RAY DEMONSTRATED THE CATHETER AT THE AXILLA, AND A VASULAR SURGEON PERFORMED A CUTDOWN BUT THE CATHETER WAS NOT LOCATED. CHEST X-RAY THEN REVEALED THE CATHETER IN THE RIGHT LUNG BASE. RADIOLOGIST THEN REMOVED THE CATHETER UNDER FLUOROSCOPY VIA THE FEMORAL VENOUS ROUTE.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE USED. THER WAS A PROBLEM WITH THE NEEDLE.
VISUAL EVALUATION OF THIS DEVICE INDICATED THAT THE ASPIRATION TUBE IS NO LONGER SECURED TO THE HANDPIECE.
ER STAFF MEMBERS WERE TREATING A PT (AGE AND GENDER UNK) WHO WAS IN A CODE SITUATION. THE STAFF CHARGED THE UNIT AND THE UNIT'S MONITOR SCREEEN "BLANKED OUT" WHILE TRYING TO DEFIBRILLATE THE PT. ON THE THIRD ATTEMPT, THE STAFF WAS ABLE TO DEFIBRILLATE THE PT. THERE IS NO INDICATION OF ANY ADVERSE EFFECT ON THE PT. THE PT WAS TRANSFERRED TO ANOTHER FACILITY. THE COMPLAINANT  INDICATED THAT THE UNIT WAS FUNCTIONING ON AC POWER AT THE TIME OF THE ALLEGED MALFUNCTION. THE UNIT WAS PLUGGED INTO A "MULTI-STRIP OUTLET" AND THE PLUGS WERE LOOSE.
DURING INITIAL START UP OF PT SUPPORT, THE FOOT PUMP TUBING WAS FOUND TO BE KINKED. BY USING A CLAMP, IT WAS POSSIBLE TO TEMPORARILY REPAIR THE KINK. THERE WAS NO IMPACT ON THE PT. A FIELD SERVICE ENGINEER REPLACED THE FOOT PUMP TUBING.
A 57-YR-OLD FEMALE UNDERWENT RECONSTRUCTION WITH SILICONE GEL BREAST IMPLANTS POST-MASTECTOMY. OVER THE YEARS, THE PT HAS HAD INCREASING PROBLEMS RELATED TO SCAR TISSUE BUILD-UP AS WELL AS FIRMNESS REGIONALLY IN THE CHEST WALL. EXAM REVEALED THICK SCAR TISSUE ALL AROUND THE IMPLANT TO THE POINT WHERE IT LOOKED LIKE A DEFORMED EDGE. THE SCAR TISSUE SHOWED EVIDENCE OF EXTRACAPSULAR EXTRAVASATION OF SILICONE WITH SILCONOMAS.
LOST SIGNALS" REPORT. CLINICIAN IDENTIFIED A BENT THERMISTOR PIN. THE CATHETER WAS REMOVED AND ANOTHER ONE WAS INTRODUCED. THE THERMISTOR PINS ON THE SECOND CATHETER ALSO "GOT BENT." THIS CATHETER WAS ALSO REMOVED AND REPLACED WITH A CO CATHETER. THE PT ULTIMATELY DIED. THE CLINICIAN FELT THAT THE INCIDENT DID NOT CONTRIBUTE TO THE PT OUTCOME ALTHOUGH SOME DELAY WAS INCURRED IN OBTAINING CARDIAC OUTPUT VALUES.
THE LOT NUMBER FOR THE PRODUCT WAS NOT AVAILABLE, THUS MFG DATE AND EXPIRATION DATE COULD NOT BE DETERMINED.
THE DEVICE PULLED APART AT THE Y CONNECTION DURING USE.
LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. NO CONCLUSION CAN BE DRAWN AT THIS TIME WITHOUT RETURNED PRODUCT EVAL.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE WOULD NOT ASPIRATE. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETED THE PROCEDURE.
11/14/1996- THIS DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF IT IS RETURNED, RESULTS OF THE EVALUATION WILL BE FORWARDED AS FOLLOW-UP TO THIS REPORT.
INVESTIGATION CONDUCTED. DR CITES THAT THERE IS NO OBVIOUS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING A TOTAL HIP REVISION SURGERY, A HIP EXTRACTOR WAS BEING USED TO REMOVE A NON-CO FEMORAL STEM AFTER REPEATED APPLICATIONS TO THE SLAP HAMMER, THE TIP OF THE EXTRACTOR BROKE. ANOTHER EXTRACTOR WAS AVAILABLE TO REMOVE THE STEM. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT CAUSED BY THIS EVENT.
SUMMARY OF EVALUATION: THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO MISUSE OF THE DEVICE BY THE USER. THIS INSTRUMENT WAS NOT DESIGNED WITH THE INTENT TO REMOVE OTHER COMPETITOR'S DEVICES. CORRECTIVE ACTION: THE AGENT IS REMINDED TO INSTRUCT THE USERS THAT THE HOOKED ADAPTOR IS DESIGNED TO REMOVE ENDOPROSTHESIS BY INSERTING THE "HOOK" INTO THE SMALL HOLE LOCATED AT THE PROXIMAL END OF THE IMPLANT.
THE DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPY. THE DEVICE WAS INSERTED AND THE BALLOON WAS INFLATED WITH 8CC SALINE. THE BALLOON BURST. A SECOND DEVICE WAS INTRODUCED AND THE SAME EVENTS OCCURRED. THERE WAS NO CONSEQUENCE TO THE PT.
AB)BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT'S BALLOONS HAD BECOME TORN DURING SURGERY, MAKING THE INSTRUMENTS NON FUNCTIONAL. THE INSTRUMENTS WERE RECEIVED WITH THE BALLOONS TORN AND THE SPACERS WERE NOT RETURNED. NO CONCLUSION COULD BE REACHED AS TO HOW THE BALLOONS HAD BECOME TORN. AB)EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. THE BALLOON MAY BECOME COMPROMISEDIF IT IS INFLATED WHILE POSITIONED IN THE CERVICAL CANAL. A LARGE UTERUS INDICATES THE USE OF THE UM202. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
REPORTEDLY "THE TUBING AREA PROXIMAL TO THE PORT RUPTURED WHEN DELIVERING DYE WITH A POWER INJECTOR." THIS OCCURRED DURING AN UNSPECIFIED RADIOLOGIC PROCEDURE. THE INJECTION RATE WAS 0.5 ML/SECOND WITH A MAXIMUM PRESSURE OF 600 PSI. THE IV SITE WAS LOST AND THE PT HAD A BLOOD LOSS OF APPROX 25 ML. A NEW IV SITE WAS ESTABLISHED AND THE PROCEDURE WAS COMPLETED.
THE LOT NUMBER FOR THE PRODUCT WAS NOT AVAILABLE. THUS, MFG DATE COULD NOT BE DETERMINED. ONE USED MACROBORE EXTENSION SET WAS RECEIVED FOR EVALUATION. EXAMINATION OF THE SET CONFIRMED THAT ITS TUBING RUPTURED NEXT TO THE CONNECTION TO THE LAV T-CONNECTOR. THE SPLIT WAS APPROX 3/4 INCH LONG RUNNING ALONG THE LENGTH OF THE TUBING WHICH WAS ALSO STRETCHED IN THAT AREA. THE SPLIT WAS THE RESULT OF EXCESSIVE PRESSURE. THIS PRODUCT WAS NOT DESIGNED FOR HIGH PRESSURE INJECTION TUBING PRODUCTS ARE AVAILABLE.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY & QUANTITY AS WELL AS INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE TUBE FELL OFF THE BURETTE. THE REPORTER INDICATED THAT THIS HAS OCCURRED SEVEN TIMES BUT DID NOT PROVIDE SPECIFIC DETAILS. ON ONE OCCASION CHEMOTHERAPY DRUGS WERE SPILLED.
THE CUSTOMER INDICATED SAMPLES WOULD BE RETURNED TO CO FOR EVALUATION. SAMPLES HAVE NOT BEEN RECEIVED. BASED ON PREVIOUS SIMILAR COMPLAINTS, CO BELIEVES THAT THIS ISSUE IS RELATED TO THE MALE LUER OF THE INTERLINK BREAKING OFF THE BURETTE AT THE BOND. THIS COMPONENT IS PURCHASED FROM ANOTHER MANUFACTURER. CO HAS NOTIFIED THE VENDOR AND HAS IMPLEMENTED MANUFACTURING PROCESS CHANGES AS CORRECTIVE ACTION. CO WAS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVALUATION. BASED ON PREVIOUS INFORMATION, CO BELIEVES THAT THIS ISSUE HAS BEEN ADDRESSED AND THAT NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
WHILE REMOVING STOPPER FROM THE TUBE, THE TUBE BROKE. THE TECHNICIAN WAS CUT ON THE THUMB. THE TECHNICIAN WAS WEARING GLOVES, AND THE WOUND WAS CLEANED. NO MEDICAL TREATMENT WAS GIVEN. BASELINE TESTING WAS GIVEN TO PT AND USER.
SECTION A THROUGH F COMPLETED BY MFR'S REPORTING SITE. ADDITIONAL DEVICE CODE TO SECTION F10: 1269. NO OTHER REPORTED COMPLAINTS ON THIS LOT. CODE 300: DHR REVIEW SHOWS NO MFG PROCESS PROBLEM.
THERE IS WHITE PARTICULATE IN THE BURETTE CHAMBER.
ONE UNIT WAS SENT TO CO FOR EVALUATION. EVALUATION OF THE RETURNED UNIT SHOWED A WHITE PIECE OF PLASTIC INSIDE THE DEVICE. THE PLASTIC IS LOOSE PARTICULATE FROM THE MOLDING PROCESS. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED PROCEDURES TO REDUCE PARTICULATE MATTER FROM THE MOLDING PROCESS. RETAINED SAMPLES WERE EVALUATED AND WERE FOUND TO BE ACCEPTABLE. THE LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE.
SYSTEM WOULD NOT FUNCTION CORRECTLY DURING A CATARACT PROCEDURE. ANOTHER SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
GUIDEWIRE BROKE AND FRAYED DURING A TRANSHEPATIC CHOLANGIOGRAM. THE WIRE WAS REMOVED FROM THE PT IN THREE PIECES.
INVESTIGATION CONDUCTED. DR CANNOT EXPLAIN CAUSE FOR FAILURE BUT DOES NOTE THAT PT IS A BRUXOR. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
TECHNICIAN WAS REMOVING CLOSURE FROM TUBE, WHEN THE TUBE BROKE. THE TECH WAS CUT ON THE THUNB. THE TECHNICIAN WAS WEARING GLOVES AND THE WOUND WAS CLEANED AND BANDAGED. NO MEDICAL TREATMENT WAS GIVEN. BASELINE TESTING WAS GIVEN TO PT AND USER.
SECTIONS A THROUGH F COMPLETED BY MFR'S REPORTING SITE. ADD DEVICE CODE TO SECTION F10: 1269. NO EVALUATION CAN BE PERFORMED AS LOT CODE IS UNK.
DURING A CATARACT EXTRACTION PROCEDURE, ASPIRATION COULD NOT BE ACHIEVED WHEN IN THE PHACO MODE. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A-F OF THIS MEDWATCH WAS COMPLETED BY THE MFR. THE DATE USED IN SECTION F.13 IS THE DATE THE REPORT WAS RECEIVED BY THE MFR.
THE DEVICE WAS USED DURING A LAPAROSCOPIC BOWEL PROCEDURE. THE WHITE TISSUE PAD BROKE OFF AND LANDED IN THE PT. THERE WAS NO CONSEQUENCE TO THE PT. THE REP REPORTED THE PROCEDURE WAS LENGTHY. THERE WAS NOT A LOT OF MESENTERY IN THE JAWS OF THE DEVICE. TO FINISH THE CASE THE SURGEON USED A SECOND DEVICE AND WAS ABLE TO REMOVE THE TISSUE PAD LAPAROSCOPICALLY.
OUTPATIENT WENT TO X-RAY FOR REMOVAL OF A PORTO CATH FRAGMENT FROM HER RIGHT HEART THAT HAD RECENTLY BEEN DISCOVERED, AND THAT HAD BEEN CAUSING OCCASIONAL ARRHYTHMIAS. A ROUGHLY 11 CM FRAGMENT WAS REMOVED FROM THE RIGHT ATRIUM AND RIGHT VENTRICLE USING A SNARE ADVANCED THRU THE RIGHT COMMON FEMORAL VEIN. IT WAS SATISFACTORILY REMOVED.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. IMPLANT SITE WAS INFECTED. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS  TYPE OF DEVICE.
THE STOPCOCK PLUG FELL OUT OF THE STOPCOCK BODY DURING SET UP.
RETAINED PRODUCT SAMPLE WERE EVALUATED. ALL FIVE SAMPLES STAYED RELATED DURING ROTATION. SET HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. IT WAS REPORTED THE BLADE TIP OF THE LCS16 BROKE OFF UPON ASSEMBLY. 9/6/96 IT WAS REPORTED ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.
THE LEAD WAS PARTIALLY EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. THE DISTAL TIP OF THE ATRIAL LEAD REMAINS ATTACHED TO THE EXISTING VENTRICULAR LEAD.
PTCA/STENT WAS PERFORMED ON PT IN THE CATH LAB. STENT WAS DEPLOYED IN THE PROXIMAL AREA OF A VEIN GRAFT IN THE LEFT ANTERIOR DESCENDING SAPHENOUS VEIN. A 4.0 DILATION CATHETER BALLOON WAS USED TO IMBED THE STENT. AT APPROX 6-7 ATM PRESSURE, THE BALLOON BURST AND WAS REMOVED. THE GUIDE WIRE WAS FOUND TO BE STUCK IN THE STENT AND BROKE WHEN BEING PULLED OUT. AN APPROX 1 INCH PORTION OF THE DISTAL END OF THE GUIDE WIRE WAS LEFT IN THE PT. THE WIRE WAS SECURED IN THE STENT AND WAS NOT RETRIEVABLE.
INVESTIGATION CONDUCTED. DR CITES THAT THE CAUSE FOR FAILURE IS DETERMINED. DR NOTES THAT HE USED SAME TECHNIQUE ON #31 AND SAME IMPLANT ON #31 & IT INTEGRATED WITH NO PROBLEMS. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
REPORT RECEIVED IN LEAD KINKED WITH WIRE FRACTURE NOT SUSPECTED.
THE PT REPORTED LOWER BLOOD GLUCOSE READINGS WITH THE FIRST BOTTLE OF 25 TEST STRIPS FROM A BOX OF STRIPS, LOT 1G518A. ON APPROX 7/20/96 THE PT OPENED THE FIRST BOTTLE OF TEST STRIPS. FOR ONE MONTH SHE OBTAINED BLOOD GLUCOSE READINGS IN THE 100 MG/DL RANGE. SHE STATED THAT SHE DID NOT NOTICE A DECREASE IN HER READINGS UNTIL 8/20/96 WHEN SHE OBTAINED BACK TO BACK BLOOD GLUCOSE RESULTS OF 11 AND 12 MG/DL. SHE FELT THIS READING WAS EXTREMELY LOW SO SHE IMMEDIATELY PERFORMED A NORMAL CONTROL SOLUTION TEST WITH THE LAST TEST STRIP FROM THE FIRST BOTTLE AND OBTAINED A RESULT OF 14 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 118-178 MG/DL (SOLUTION LOT VK294, EXP DATE: 2/96). THE CONTROL SOLUTION WAS OPENED ON APPROX 8/15/96. PT SHOOK THE SOLUTION BEFORE SHE APPLIED THE SAMPLE TO THE TEST PAD. ON 8/21/96, WITH THE CO REPRESENTATIVE, THE PT OPENED THE SECOND BOTTLE FROM THE SAME BOX OF STRIPS AND OBTAINED A BLOOD GLUCOSE RESULT OF 100 MG/DL. THE PT THEN PERFORMED A NORMAL CONTROL SOLUTION TEST AND A CHECK STRIP TEST WITH THE REPRESENTATIVE. SHE OBTAINED A NORMAL CONTROL SOLUTION RESULT OF 142 MG/DL. SHE OBTAINED A CHECK STRIP RESULT OF 79 VERSUS A CHECK STRIP OF 70-94. THE DESICCANT IS IN BOTH BOTTLES OF STRIPS. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE PT STORES THE TEST STRIPS IN HER BEDROOM AND DOES NOT EXPOSE THEN TO EXTREME HEAT, COLD OR MOISTURE AS DIRECTED IN CO'S PACKAGE INSERT. SHE DOES NOT KEEP THE TEST STRIP BOTTLES OPEN FOR A PROLONGED PERIOD OF TIME.
ALL THE RETENTION SAMPLE TEST RESULTS FOR LOT 1J518A MEET THE SPECIFICATIONS FOR THE BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. CUSOTMER REPORTED BOTTLE HAD BEEN IN USE FOR ONE MONTH PRIOR TO FAILING, BUT DID NOT GIVE ENOUGH INFO FOR CO TO DETERMINE THE CAUSE OF FAILURE. ALL TEST STRIPS HAD BEEN CONSUMED, THEREFORE, CO COULD NOT EVALUATE TEST STRIPS. CUSTOMER INDICATED THAT RESULTS FROM COMPANION BOTTLE OF STRIPS WERE ACCEPTABLE   BASED ON THE EVALUATION OF RETENTION SAMPLE AND TREND ANALYSIS. THE PROBABILITY THAT THIS WAS A PRODUCT MALFUNCTION IS LOW AND IT IS UNLIKELY TO RECUR. IS EVENT OCCURRING MORE FREQENTLY THAN STATED IN LABELING?N. IS EVENT OCCURRING MPRE FREQUENTLY THAN IS USUAL FOR DEVICE?N. IS EVENT OCCURRING WITH THE GREATER SEVERITY THAN STATED IN LABELING?N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE?N. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
INVESTIGATION CONDUCTED. DR CITES THAT AN INFECTION IN TOOTH #21 MAY HAVE AFFECTED THE IMPLANT SITE AND POSSIBLY CAUSE THE FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PTCA/STENT WAS PERFORMED ON PT IN THE CATH LAB. STENT WAS DEPLOYED IN THE PROXIMAL AREA OF A VEIN GRAFT IN THE LEFT ANTERIOR DESCENDING SAPHENOUS VEIN. A 4.0 DILATATION CATHETER BALLOON WAS USED TO IMBED THE STENT. AT APPROX 6-7 ATM PRESSURE, THE BALLOON BURST AND WAS REMOVED. THE GUIDE WIRE WAS FOUND TO BE STUCK IN THE STENT AND BROKE WHEN BEING PULLED OUT. AN APPROX 1 INCH PORTION OF THE DISTAL END OF THE GUIDE WIRE WAS LEFT IN THE PT. THE WIRE WAS SECURED IN THE STENT AND WAS NOT RETRIEVABLE.
REPORT RECEIVED OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
OUTPATIENT ADMITTED FOR CHEMOTHERAPY FOR DYE INJECTION TO PORTO CATH. EXTRAVASATION PRESENT WHERE THE CATHETER CROSSES UNDER THE CLAVICLE. CONCLUSION BY RADIOLOGIST THAT EXTRAVASATION OF CONTRAST FROM THE PROXIMAL CATHETER IS CONSISTENT WITH FRACTURE OF THE CATHETER. CHEMOTHERAPY WAS NOT GIVEN THROUGH THE PORTOCATH.
ALL KEY SWITCHES ON THE FRONT PANEL OF THIS UNIT HAVE CEASED TO FUNCTION. ANOTHER  UNIT WAS USED FOR THE PROCEDURE.
SECTIONS A-F OF THIS MEDWATCH WAS COMPLETED BY THE MFR. THE DATE USED IN SECTION F.13 IS THE DATE THE REPORT WAS RECEIVED BY THE MFR. BALANCED SALT SOLUTION CONTAMINATED THE CONTROL CIRCUIT CARD ALLOWING THE UNIT TO BE CONTROLLED BY THE REMOTE BUT NOT BY THE FRONT PANEL.
PACEMAKER GENERATOR EROSION; S/P VVI PACEMAKER IMPLANTATION.
INVESTIGATION CONDUCTED. DRS DO NOT CITE ANY CAUSE FOR FAILURE. PT IS A SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
FACILITY REPORTED THAT 15 MINUTES INTO HEMODIALYSIS TREATMENT, THE PT COMPLAINED OF SEVERE BACK PAIN AND SHORTNESS OF BREATH. THE PT WAS GIVEN 25 MG IV BENADRYL AND OXYGEN AT 2 L/MIN. PHYSICIAN WAS NOTIFIED OF PT'S CONDITION. BLOOD PRESSURE WAS 177/78, PULSE 112. PT'S BLOOD WAS RINSED BACK AND PT WAS PUT ON A DIFFERENT DIALYZER. TREATMENT WAS RESUMED WITHOUT FURTHER INCIDENT. THE SAMPLE WAS DISCARDED BY THE UNIT.
MANY CONDITIONS CAN AFFECT A PT'S REACTION TO DIALYZERS, SUCH AS PROCESSING SOLUTIONS, MEDICATIONS, PRIMING PROCEDURE, SENSITIVITIES TO PARTICULAR MEMBRANES, AND MEDICAL CONDITION. ALL DIALYZERS ARE STERILE AND NON PYROGENIC AND HAVE BEEN CHECKED PRIOR TO SHIPMENT. SINCE THE PT REACTION OCCURRED DURING REUSE,. IT IS POSSIBLE THE REPROCESSING TO THE UNIT MAY HAVE AFFECTED IT.
DURING A LAPAROSCOPIC HERNIA REPAIR, WHILE SEWING THE PERITONEUM, THE SURGEON COULD NOT GET THE NEEDLE HOLDER TO OPEN. THE SURGEON PULLED THE HANDLES APART WITH BOTH HANDS TO OPEN. A SMALL AMOUNT OF PERITONEUM REMAINED IN THE NEEDLE HOLDER JAWS. THERE WAS NO CONSEQUENCE TO THE PT.
THE FOOT PEDAL FOR THIS OPHTHALMIC MICRODURGICAL UNIT STOPPED WORINGING DURING A CATARACT EXTRACTION PROCEDURE.
HOSP WAS USING A DEFIBRILLATOR/MONITOR/PACER WITH ANOTHER CO'S DEFIBRILLATOR ELECTRODES DURING CODE BLUE. PT WAS IN CARDIAC ARREST, WAS DEFIBRILLATED AND THEN PACED. PACER FUNCTION WAS STOPPED TO CHECK UNDERLYING RHYTHM. WHEN ATTEMPTING TO RESTART PACING, RECEIVED THE "PADS OFF" ALARM. UNABLE TO PACE PT.
WHILE TRANSFERRING RESIDENT WITH LIFT, PRESSURE RELEASE VALVE WAS TURNED AND RESIDENT RAPIDLY DESCENDED HITTING HEAD AND CAUSING SEVERE INJURY. VALVE RELEASE IS DIFFICULT TO REGULATE SLOW DESCENT.
TWO BLOOD LEAKS OCCURRED ON DIALYZERS IN THEIR 3RD AND 6TH REUSES. NO SIGNIFICANT BLOOD LOSS FOR EITHER PT.
DIALYZER UNIT NOT RETURNED FOR TESTING. NO ABNORMALITY WAS FOUND ON CO'S MFG RECORD OR SHIPPING TEST RECORD OF THE QUESTIONED CODE AND LOT NUMBER. CO CAN ONLY PRESUME THAT SOME FACTOR OF REPROCESSING MAY HAVE INFLUENCED THE STRENGHT OF THE FIBERS.
UNIT CONTINUED TO IRRIGATE AFTER FOOT IS OFF THE FOOT PEDAL AND ON PHACO MODE. PRESSING ON THE FOOT PEDAL CAUSES THE SETTINGS ON THE SCREEN TO REVERT TO ZERO.
PORT CATHETER REMOVED 13 DAYS AFTER IMPLANT BECAUSE PT DEVELOPED SWELLING AT THE ELBOW DURING CHEMOTHERAPY INFUSION. A CATHETER GRAM CONFIRMED EXTRAVASATION OF THE CONTRAST AT THE ELBOW. UPON REMOVAL OF CATHETER/RESERVOIR, A SPLIT OF THE CATHETER (AT THE HUB) WHERE IT CONNECTS TO THE RESERVOIR WAS IDENTIFIED.
WHILE REMOVING A DRAIN FROM A FEMALE PT FOLLOWING A "COLPOSUSPENSION", THE DRAIN BROKE. APPROX 17 CMS OF DRAIN REMAINED IN THE PT. THE RETAINED PORTION WAS RETRIEVED WITHOUT SURGICAL INTERVENTION. THIS EVENT DID NOT RESULT IN ANY ADVERSE CONSEQUENCE TO THE PT.
DATE SENT TO FDA: 09/27/96. H6-ADD'L METHODS CODE-#38.EVAL OF THE RETURNED SAMPLE SUGGESTS THAT THE PRODUCT WAS BEING USED IN A MANNER OR SITUATION WHICH WAS INAPPROPRIATE GIVEN THE PRODUCT'S INTENDED FUNCTION OR PERFORMANCE LIMITATIONS. VISUAL INSPECTION OF THE SAMPLES AS WELL AS PHOTOGRAPHIC EXAMINATION (AT THE BROKEN AREAS) INDICATES THAT THE DRAIN MAY HAVE BEEN NICKED DURING THE OPERATION BY A SHARP EDGED INSTRUMENT. PRECAUTIONS INCLUDED IN THE PRODUCT INSERT STATE: THE SILICONE ELASTOMER SUCTION DRAIN TUBING IS SOFT AND PLIABLE. IT SHOULD NOT BE HANDLED WITH POINTED, TOOTHED, SHARP-CORNERED OR EVEN BLUNT INSTRUMENTS, AS PUNCTURES, SURFACE CUTS, NICKS, CRUSHING OR OTHER OVERSTRESSING CAN LEAD TO TEARING OR WARPING OF THE TUBING AND TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN AND/OR FRAGMENT RETENTION WITHIN THE WOUND. THE PRODUCT SAMPLE PROVIDED MAY HAVE BEEN SUBJECTED TO POINTED, TOOTHED, SHARP-CORNERED OR BLUNT INSTRUMENTS. OVERSTRESSING OF THE TUBING CAN LEAD TO TEARING OR WARPING AS INDICATED IN THE INSERT PRECAUTIONS. DATA ANALYSIS INDICATES THAT COMPLAINTS OF THIS TYPE ARE NOT SIGNIFICANT RELATIVE TO THE VOLUME OF DRAINS SOLD, HOWEVER, TRENDS WILL CONTINUE TO BE MONITORED. NO FURTHER INVESTIGATION WILL BE CONDUCTED UNLESS WARRANTED BY AN UNEXPECTED AND SIGNIFICANT INCREASE IN COMPLAINTS.
THE CUSOTMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION RESULTS WITH TST STRIPS. ON 8/20/96, HE OPENED THE SECOND BOTTLE IN A BOX OF FIFTY AND OBTAINED BACK TO BACK CONTROL SOLUTION RESULTS OF 5 AND 8 MG/DL WITH STRIPS VERSUS A NORMAL CONTROL SOLUTION RANGE OF 114-170. THE CONTROL SOLUTION, ANOTHER BRAND NORMAL CONTROL SOLUTION, LOT# VC075, EXPIRATION 3/97, WAS OPENED TWO MONTHS AGO AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. THE CUSTOMER CALLED THE CUSTOMER SUPPORT LINE AND WITH THE REPRESENTATIVE, PERFROMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 6 MG/DL. ALSO WITH THE REPRESENTATIVE, PERFORMED A CHECK STRIPS TEST, TH RESULT WAS 94 VERSUS A RANGE OF 88-109. THE DESICCANT WAS TAKEN OUT BY THE CUSTOMER WHEN HE OPENED THE BOTTLE. THE STRIPS WERE STORED IN HIS BED TABLE. THE CUSTOMER STATED THAT THE FIRST BOTTLE IN THE BOX PERFORMED ACCURATELY.
THE CUST3OMER RETURNED TEST STRIPS WERE EVALUATED ON 9/11/96. ONE OPENED BOTTLE, CONTAINING 4 STRIPS WITHOUT DESSICANT WAS RETURNED TO QA FOR EVALUATION. THE TEST RESULT OF NORMAL CONTROL SOLUTION FOR THE RETURNED BOTTLE FELL BELOW THE SPECIFIED RANGE. CUSTOMER STATED THAT THE DESSICANT WAS TAKEN OUT WHEN HE OPENED THE BOTLE AND THIS EXPLAINS THE LOW RESULT OBTAINED BY CO. ALL THE RETENTION SAMPLE RESULTS FOR LOT 1J501B MEET ALL THE SPECIFICATIONS FOR THE BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. BECAUSE CUSTOMER REMOVED THE DESSICANT WHEN HE OPENED THE BOTTLE, IMPROPER USE AND STORAGE OF PRODUCT BY THE CUSTOMER HAD OCCURRED. SINCE THE COMPLAINT OF LOW READINGS WERE OBTAINED ON THE SAME DAY THE BOTTLE WAS OPENED, THE COMPLAINT OF THESE LOW READINGS IS NOT LIKELY DUE TO THE IMPROPER USE AND STORAGE BY REMOVING THE DESSICANT. BASED ON THE EVALUATION OF RETENTION SAMPLES AND TREND ANALYSIS, THE RISK OF FURTHER PRODUCT FAILURES IN THE FIELD IS LOW. THE CUSTOMER'S COMPLAINT IS UNLIKELY BECAUSE THE TOTAL NUMBER OF TEST STRIPS RETURNED TO CO WAS FOUR. THIS INDICATES THAT 21 TESTS WERE PERFORMED BY THE CUSTOMER IN ONE DAY. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING?N. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE?N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING?N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE?N. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CINSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
PORT CATHETER INSERTED ON 5/16/96 FOR CHEMOTHERAPY. POSITION VERIFIED BY CHEST X-RAY. PT RECEIVED TWO (2) ROUNDS OF CHEMO FOR A TOTAL OF 44 TREATMENTS. THE CATHETER WAS NOTED ON X-RAY (ON APPROX 8/12/96) TO BE DETACHED FROM THE PORT. THE CATHETER WAS RETRIEVED PERCUTANEOUSLY BY A RADIOLOGIST IN ANOTHER FACILITY. CATHETER REMOVED AND NEW ONE INSERTED ON 8/26/96.
THE PUMP WOULD NOT FUNCTION WHEN HOSP PERSONNEL ATTEMPTED TO USE IT ON AN EMERGENCY PT. THE SCREEN WAS BLACK AND BLACK. THEY PUT THE PUMP ON STANDBY BUT NOTHING WOULD DISPLAY ON THE MONITOR. THE PT WAS CRITICALLY ILL AND DID EXPIRE. HOWEVER, THIS INCIDENT DID NOT CONTRIBUTE TO THE PT'S DEATH.
MFR CONTROL NO DI96-203. THIS INCIDENT WAS INVESTIGATED BY THE ARROW FIELD SVC REP. ITEMS REPLACED WERE: CRT ASSEMBLY, 9 VOLT POWER SUPPLY, 14 VOLT POWER SUPPLY, AND THE BATTERIES AND UMBILICAL CORD. THE UNIT WAS THEN TESTED AND PERFORMED NORMALLY.
DURING A CATARACT EXTRACTION PROCEDURE, THIS OPHTHALMIC MICROSURGICAL SYSTEM RESET.
SECTIONS A-F WERE COMPLETED BY MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. REPORTED PROBLEM MAY HAVE BEEN CAUSED BY A LOOSE CORD.
THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH TEST STRIPS. SHE OPENED THE BOTTLE OF TEST STRIPS ON APPROX. 9/1/96 AND PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 175 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 106-160 MG/DL. BECAUSE THIS READING WAS NOT IN RANGE, SHE PERFORMED A SECOND CONTROL TEST. THE RESULT WAS 210 MG/DL. THE NORMAL CONTROL SOLUTION WAS OPENED APPROX. TWO MONTHS AGO AND THE CUSTOMER SHOOK IT WELL BEFORE TESTING. WHILE SPEAKING TO THE CO'S REP, A THIRD NORMAL CONTROL SOLUTION TEST AND THE RESULT WAS 168 MG/DL. A CHECK STRIP TEST, ALSO PERFORMED WITH THE REP WAS 72 VERSUS A CHECK STRIP RANGE OF 58-90. THE CODE WAS SET CORRECTLY FOR ALL TESTS. THE DESICCANT IS IN THE BOTTLE OF TEST STRIPS.
THE RETENTION SAMPLE TEST RESULTS FOR DEVICE MEET THE SPECIFICATIONS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIC RANGE. TREND ANALYSIS OF COMPLAINTS SHOWS THIS IS THE FIRST COMPLAINT FOR DEVICE. CO REQUESTED THAT THE PRODUCT BE RETURNED FOR EVALUATION ON 9/4/96. AS OF 10/2/96, PRODUCT HAS NOT BEEN RECEIVED. NO FURTHER INVESTIGATION IS POSSIBLE. BASED ON THE EVAL OF RETENTION SAMPLES AND TREND ANALYSIS, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? U. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? U. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N.
THE CUSTOMER REPORTED INACCURATELY HIGH BLOOD GLUCOSE READINGS WITH TEST STRIPS, LOT# 1H506B. SHE PERFORMED TWO SIDE BY SIDE COMPARISONS USING DIFFERENT BRAND TEST STRIPS AND CO TEST STRIPS. THE RESULTS WERE 12 MG/DL VERSUS 162 MG/DL AND 98 MG/DL AND 131 MG/DL RESEPECTIVELY. THE CODE WAS SET CORRECTLY FOR ALL TESTS, BOTH BRANDS OF TEST STRIPS ARE CODE 8. THE DESICCANT IS IN THE BOTTLE OF CO TEST STRIPS. THE CUSTOMER PERFORMED A NORMAL CONTROL SOLUTION TEST ON BOTH BRANDS OF TEST STRIPS AND BOTH RESULTS WERE IN RANGE (NO SEPCIFIC RESULTS AVAILABLE). A CHECK STRIP TEST RESULT WAS ALSO IN RANGE (NO SPECIFIC RESULT AVAILABLE). BECAUSE SHE DID NOT HAVE HER METER OR TEST STRIPS WITH HER AT THE TIME OF THE CALL, THERE WERE NO TESTS PERFORMED WITH THE CO REPRESENTATIVE. THE CUSTOMER HAS 3 BOXES OF LOT# 1H506B, AND SHE STATED THAT THEY ARE ALL READING APPROX 30-40 MG/DL HIGHER THAN DIFFERENT BRAND TEST STRIPS.
THE INVESTIGATION OF THE PRESENT COMPLAINT HAS NOT BEEN COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FORWARD TO FDA. THE TIME FRAME IS APPROX FOUR WEEKS. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED  IN LABELING?.N. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE?N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING?N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE?N. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
PT ON EPIDURAL PUMP. ORDERS FOR MEDICATION: DURAMORPH, 0.1 MG/CC AT 2 CC/HR. PT'S PUMP FOUND ADMINISTERING BASAL RATE 2 MG/HR, VOLUME LIMIT INFUSED 43 CC. EPIDURAL TURNED OFF AND ANESTHESIA CALLED. RR AT 6/MIN, NARCAN ADMINISTERED WITH IMMEDIATE RESULTS. NO APPARENT UNTOWARD OUTCOME.
RESEARCH ASSISTANT NOTICED NUMBERS DID NOT SEEM CORRECT, IMMEDIATELY STOPPED THE INFUSION AND CHANGED THE PUMP. PT WAS RECEIVING A PLACEBO AT THE TIME.
SECTION F COMPLETED BY MFR. REPORTER SUBMITTED FORM 3500. ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL. CODE 2199- PT ON PLACEBO. THE PUMP WAS TESTED BY RUNNING A 13 HOUR PROGRAM FIVE TIMES EACH TIME THE PUMP PERFORMED ACCORDING TO SPEC. SHORT TERM DELIVERY ACCURACY TESTS WERE ALSO RUN AND AGAIN PUMP OPERATED ACCORDING TO SPEC. THE ALLEGED OVER INFUSION COULD NOT BE REPRODUCED.
ALL "UNK" INFO REQUEST BUT NOT RECEIVED. SECTION F INFO PROVIDED BY THE MFR. INTERNAL #1996080001.
FACILITY REPORTED THAT 15 MINUTES INTO HEMODIALYSIS TREATMENT, PT COMPLAINED OF SEVERE LOWER BACK PAIN AND SHORTNESS OF BREATH. PT WAS GIVEN BENADRYL AND OXYGEN WITHOUT RELIEF. PT'S BLOOD WAS REINFUSED AND SYMPTOMS SUBSIDED. THE PT WAS DISCHARGED FROM THE UNIT AFTER ONE HOUR AND NO DISCOMFORT WAS NOTED. SAMPLE WAS DISCARDED BY THE FACILITY.
DEVICES ARE CHECKED FOR SAFETY AND STERILITY PRIOR TO SHIPMENT. GENERALLY, PT REACTIONS ARE ASSOCIATED WITH SUDDEN TREATMENT AND MEDICAL CONDITION OF PT. SINCE THE PT REACTION OCCURRED DURING REUSE, IT IS POSSIBLE THE REPROCESSING OF THE UNIT MAY HAVE AFFECTED IT.
THE DEVICE DISPLAYED REPEATED "CHECK ELECTRODES" PROMPTS IN PT USE.
THE LOCAL FACTORY SERVICE REP OBSERVED PROPER OPERATION THROUGH FULL PERFORMANCE AND PERFORMANCE TESTING. THE FACILITY SUBSEQUENTLY HAS CONCLUDED THE REPORT IS A RESULT OF OPERATOR ERROR, IN THAT THE OPERATOR DID NOT ADEQUATELY CONNECT THE DEVICE DEFIBRILLATION ELECTRODES. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
CUSTOMER CLAIMED THAT A TROCAR TESTED PRIOR TO SURGERY "FAILED TO RETRACT AS IT SHOULD HAVE" CO QUALITY ASSURANCE WAS NOT ABLE TO DUPLICATE THE ALLEGED FAILURE-DEVICE RETRACTED 100 TIMES AND CONFORMED TO ALL SPECS. THE FAILURE WAS LIKELY TECHNIQUE RELATED. CO BELIEVES IN-SVC OF HOSP PERSONNEL WILL PREVENT THIS TYPE OF CONFUSION FROM RECURRENCE.
OBSERVATION ON FAILURE: CUSTOMER HAS CLAIMED THAT THE TIP DID NOT RETRACT. RETURNED PRODUCT WAS TESTED 100 TIMES WITH NO DUPLICATION OF STATED FAILURE. CAUSE OF FAILURE: UPON DISASSEMBLING THE DEVICE, NOTHING OUT OF THE ORDINARY WAS FOUND ON ANY OF COMPONENTS OR ASSEMBLIES. NO CAUSE CAN BE CONFIRMED FROM THE RETURNED PRODUCT. IT IS LIKELY THAT FAILURE IS A TECHNIQUE RELATED FAILURE. LONG TERM CORRECTIVE ACTION: NO ACTION WILL BE TAKEN AT THIS TIME. THE TROCAR RETRACTED AS INTENDED AFTER CYCLES.
THERE WAS PARTICULATE IN THE DRIP CHAMBER.
FOUR SAMPLES WERE RETURNED TO CO FOR EVAL. EXAM OF THE RETURNED UNIT SHOWED THAT ONE SAMPLE HAD FINE PARTICULATE MATTER INSIDE THE DRIP CHAMBER. THIS PARTICULATE MATTER IS FROM THE MOLDING PROCESS. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED PROCEDURES TO REDUCE PARTICULATE MATTER FROM THE MOLDING PROCESS.
THIS UNIT FAILED DURING A POSTERIOR VITRECTOMY PROCEDURE. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE.
THE POSTERIOR IOP SWITCH WAS WORKING PROPERLY BUT THERE WAS NO IAP OUTPUT. THE P5 CONNECTOR ON THE PNEUMATIC INTERFACE BOARD WAS ONLY CONNECTED HALF WAY. THE CONNECTOR WAS RESEATED PROPERLY. THE BACK PANEL FAN WAS DISCONNECTED AND THE VITRECTOMY VALVE MUFFLER WAS MISSING. THE PROBLEMS WERE CORRECTED AND THE UNIT THEN PASSED ALL TESTS.
THIS UNIT EXHIBITED INTERMITTENT PHACO CALIBRATION DURING SET UP. THE PT HAD BEEN PREPPED FOR THE PROCEDURE.
RECALIBRATED ASPIRATION AND REPLACED THE RECEPTABLE PANEL THAT WAS CORRODED WITH BALANCED SALT SOLUTION.
ALLEGED AUTOIMMUNE DISEASE AND MULTIPLE VARIED INJURIES. FOLLOW UP FINDINGS: UNSUBSTANTIATED BY A HEALTH PROFESSIONAL. OUTCOME: UNDETERMINED.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATRED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. MCGHAN MEDICAL DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF MMC'S EVALUATION OF THE DEVICE. MCGHAN MEDICAL'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. FILING A MDR DOES NOT CONSTITUTE AN ADMISSION BY MMC THAT THE DEVICE HAS MALFUNCTIONED,  NOR DOES IT ESTABLISH THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. REPORTS ARE BASED ON INFO SUPPLIED TO MCGHAN MEDICAL AND THE SUBSEQUENT INVESTIGATION. CO CONSIDERS THIS INFO TO BE HIGHLY CONFIDENTIAL AND, THEREFORE, REQUESTS ITS PROTECTION FROM ANY REQUEST, PURSUANT TO 21 CFR PART 803.0 (B).
READMIT OF LEFT CAROTID-ENDORECTOMY REPAIR OF PRIOR SURGERY (PERFORMED 9/5/96) INITIAL SURGERY DATE 9/5/96; 9:10 AM. READMIT OF PT FOLLOWING FIRST REPAIR. BREAK IN SUTURE LINE DISCOVERED UPON REMOVAL OF CLOT. AUTOLOGUS REPAIR USING SAPHENOUS VEIN 9/5/96; 1:45 PM 2ND REPAIR -RUPTURE OF LEFT CAROTID *BREAK IN SUTURE LINE DISCOVERED 9/7/96. DEVICE EXPIRATION DATE IS INDICATED AS 5/31/2001.
10/9/96 SUBMITTED INITIAL REPORT TO FDA.
MAINTENANCE RAN GENERATOR ON 9/19/96 AT 1 PM. NURSING STAFF CALLED CARDIOPULMONARY AND REPORTED THAT VENT HAD SMOKE COMING OUT OF IT. MACHINE WAS TAKEN OUT OF SVC. PT SUFFERED NO INJURIES.
10/14/96- SUPPLEMENTAL REPORT SUBMITTED TO FDA BY MFG. RECEIVED MEDWATCH REPORT FROM THE USER FACILITY FOLLOWING CO'S INITIAL SUBMISSION.
RECEIVED INFO ON 8/10/96 THAT PT HAS HAD SEVERAL TUBINGS THAT HAD LEAKED WITH SIDE INJECTION PORT. DATE OF EVENT 8/9/96 - 8/10/96.
WHEN MEDICINE IS INJECTED INTO NEEDLELESS PORT, TUBING BECOMES DISCONNECTED DURING CRITICAL POINT IN THE ANESTHETIC CARE OF THE PT. THIS TUBING HAS MALFUNCTIONED DURING SEVERAL ANESTHESIA EVENTS BY DISCONNECTING AT THE "PUMP SEGMENT" WHEN MEDICATION IS INJECTED IN PROXIMAL NEEDLELESS VALVE THEREBY CONTAMINATING THE TUBING AND LOSING THE MEDICATION INJECTED.
THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION PROCEDURE. THE DEVICE WAS USED ON AN OBESE PT. REPORTEDLY, THE DISTAL STAPLE LINE DID NOT FIRE AT ALL AND SEVERAL STAPLES DID NOT CRIMP. LEAKAGE WAS OBSERVED. THE SURGEON MANUALLY REMOVED THE STAPLES AS THE TEMPORARY ILEOSTOMY WAS CONSTRUCTED. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY. DEVICE EXPIRATION DATE IS INDICATED AS 6/30/2001.
10/9/96 -MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE DEVICE WAS REMOVED FROM THE PT DUE TO PAIN AND PT DISCOMFORT-PUMP TOO HIGH. ANOTHER DEVICE WAS IMPLANTED. ADD'L LOT AND SERIAL NUMBER: AN525 007.
PUMP HAD OR DAMAGE. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. CYLINDER HAD OR DAMAGE.
PT WAS BEING REMOVED FROM BACK OF AMBULANCE ON AN EMS STRETCHER WHEN THE LEGS TO THE COT DID NOT COMPLETELY UNFOLD AND SECURE CAUSING THE HEAD OF THE COT TO DROP APPROX 18-20 INCHES DOWN. THE PT REMAINED ON COT RESTRAINED THROUGHOUT. PT UNINJURED AND NO COMPLAINT.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS-BOTH CYLINDERS-AND REPLACED.
ON 8/24, THE PT BEGAN OBTAINING READINGS IN THE "30'S AND 40"S ON HER METER. BASED UPON THE RESULTS, SHE CEASED TAKING HER INSULIN. HER PHYSICIAN WAS CONTACTED(UNKNOWN DATE) AND SHE WAS ADVISED TO DRINK ORANGE JUICE. ON 8/27, THE PT WAS "PALE AND WET" AND WAS TRANSPORTED TO AN URGENT CARE FACILITY WHERE A LAB BLOOD GLUCOSE RESULT OF ">400" WAS OBTAINED. SHE WAS TREATED WITH INSULIN AND SENT HOME. THE METER IS REPORTEDLY CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, HOWEVER IT IS CLEANED ONLY WHEN IT DISPLAYS "CTA" (CLEAN TEST AREA). SEVERAL CALIBRATIONS TESTS WERE ATTEMPTED ON 9/8 WITH RESULTS OF "NOT OKAY."
H6 RESULT:  NO NON-CONFORMANCES.  CO IS UNABLE TO COMPLETE THEIR INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE DUE TO THE FACT THAT THE METER WAS NOT RETURNED TO LIFESCAN.  THEREFORE, CO HAS NOT BEEN ABLE TO EVALUATE THE METER TO DETERMINE WHETHER OR NOT A DEVICE MALFUNCTION MAY HAVE CONTRIBUTED TO THIS EVENT.  BATCH RECORD REVIEW INDICATES NO NON-CONFORMANCES IN THE MANUFACTURING PROCESS.  AT THIS POINT, CO CONSIDERS THIS MATTER CLOSED.  H6=BATCH RECORD REVIEW.
THE DEVICE WAS APPLIED DURING A HYSTERECTOMY WITH BILATERAL SALPINGOOOPHERECTOMY ON 8/3/94. THE SURGERY WAS COMPLETED WITH NO APPARENT COMPLICATIONS. THE PT COMPLAINED OF ABDOMINAL PAIN IN 4/96. REPORTEDLY, METAL STAPLES WERE PROTRUDING THROUGH THE VAGINAL CUFF. 5/28/85 -STAPLES WERE REMOVED.
10/9/96 -MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. MFG RECEIVED INFO FROM A PT AND HEALTHCARE PROFESSIONAL ALLEGING THE DEVICE USED DURING HER HYSTERECTOMY PROCEDURE CONTAINED METAL STAPLES INSTEAD OF POLYMER STAPLES. DUE TO A CLERICAL ERROR, THE STATUTORY MDR FILING DATE WAS MISSED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. TUBING HAD OR DAMAGE.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PATIENT DUE TO FLUID LOSS, RIGHT CYLINDER, AND REPLACED. INFO RECEIVED ON 10/10/96 INDICATES ADDITIONAL REASON AS EROSION.
WHILE UNLOADING ROD FROM POLYAXIAL SCREW, THE INNER SCREW AND OUTER NUT "SPRANG" OFF THE POLYAXIAL SCREW, CAUSING THE END TO DISLODGE.
THE IPP DEVICE WAS REMOVED FROM THE PT DUE TO AN ANEURYSM IN THE RIGHT CYLINDER AND REPLACED. LOT AND SERIAL NUMBER: 4273P 005.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD TORN FABRIC AND BULGING. TUBING WAS FUNCTIONAL.
WHEN USING THE "HADLOCK FORMULA MODE" DURING THE 12 TO 13 WEEK PERIOD (1ST TRIMESTER) TO DETERMINE FETAL CALCULATIONS, THE UNIT FAILS TO CALCULATE THE AVERAGE PROPERLY. INSTEAD OF APPROPRIATELY AVERAGING 13 WEEKS, THE SOFTWARE CAUSES AN AVERAGE OF 14 WEEKS TO BE DISPLAYED THUS GIVING THE PHYSICIAN INACCURATE DATA TO DIAGNOSE THE CORRECT AGE OF THE FETUS BASED ON ITS SIZE. THE UNIT WORKS FINE IN THE "AVERAGE MODE." SOFTWARE REVISIONS 5.51, 5.53, 5.6, AND 5.7 ARE AFFECTED AND WILL MISCALCULATE THE FETUS AGE WHEN USING THE "HADLOCK FORMULA MODE."RPTR NOTIFIED THE MFR AND ITS PARENT CO AND BOTH SAID THEY ARE AWARE OF THE SOFTWARE PROBLEMS. RPTR HAS DETERMINED THAT THE SOFTWARE IN FACT IS FAULTY.
DEVICE WAS REMOVED FROM TH EPT DUE TO FLUID LOSS IN THE RIGHT CYLINDER. ANOTHER DEVICE WAS IMPLANTED.
SUTURE BREAKAGE POST OPERATIVE. USER FACILITY REPORTED SUTURES BROKE IN MIDDLE AFTER PT COUGHED ACCORDING TO PHYSICIAN WHICH LED TO WOUND EVISCERATION REQUIRING A RE-OP TO REPAIR.
H6 -100 FOURTEEN SAMPLES (ONE OF BATCH JD2713, 200 THREE OF BATCH JC2783 AND TEN OF BATCH HLE133) OF THE RETURNED PRODUCTS WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND THE RESULTS OBTAINED WERE ABOVE THE CO'S REQUIREMENTS, WHICH ALWAYS EQUAL OR EXCEED THE MINIMUM USP REQUIREMENTS. G1 -ETHICON, INC. ROAD 183, P.O. BOX 982. SAN LORENZO. PR 00754. H4 -DEVICE MFG DATE: LOT # HLE133 -10/95. LOT # JC2783 -3/96.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT DUE TO INADEQUATE RIGIDITY AND REPLACED.
DURING A PTCA PROCEDURE, DISSECTIONS OCCURRED. IT WAS ALSO REPORTED BY THE PHYSICIAN THAT THE VESSEL WAS VERY FRAGILE AND THE DISSECTIONS WERE NOT CAUSED BY THE BALLOON CATHETER. THE PHYSICIAN DETERMINED SURGERY WOULD NOT BE PERFORMED. PT STATUS IS LISTED AS "OK".
THE BALLOON CATHETER WAS DISCARDED BY THE HOSPITAL, SO NO RETURNED PRODUCT ANALYSIS WILL BE AVAILABLE.
DURING A GRAFT RE-DILATION PROCEDURE IN WHICH A STENT HAD PREVIOUSLY BEEN PLACED, THE CATHETER BALLOON RUPTURED AFTER SEVERAL INFLATIONS AT 12 ATM. THE CATHETER SHAFT WAS PUSHED UP AGAINST THE WALL STENT AT THE GRAFT CURVE & WAS PINCHED OFF. WHEN THE CATHETER WAS REMOVED, THE DISTAL TIP & BALLOON WERE MISSING. A GOOSENECK SNARE WAS SUCCESSFUL IN REMOVING THE INDWELLING PIECE.
BLOCK B6 & B7 WERE CHANGED TO "UNK" AS THE INFO WASN'T PROVIDED ON THE USER'S ATTACHED MEDWATCH REPORT. BLOCK H6, CONLCUSION CODE 68, USED AS THE PRODUCT WAS BEING USED AGAINST IT'S LABELED INDICATIONS.CODE 2177-NOT LABELED.CODE 2199-NOT LABELED.CODE 1638 LABELED.CODE 1670-LABELED.THE USERS MEDWATCH REPORT, IN BLOCK B2, HAS CHECKED "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE" THIS REPORT WAS ORIGNIALLY FILED AS A TEMPORARY IMPAIRMENT AND WILL REMAIN THAT TYPE OF REPORTABLE EVENT-NO CHANGE MADE.
DEVICE WAS REMOVED FROM THE PT DUE TO A LEAK IN THE LEFT CYLINDER. ANOTHER DEVICE WAS IMPLANTED. LOT AND SERIAL NUMBER: 9552J 007.
SURGEON UPON RECHECKING KNOT SECURITY, NOTICED ONE OF THE KNOTS EXPHIBITING A SPRING BACK EFFECT. UPON PULLING THE TAIL OF THE KNOT IT BEGAN TO UNTIE. SURGEON DECIDED TO REMOVE SUTURE AND RE-SUTURE WHICH ADDED CONSIDERABLE TIME TO THE SURGICAL PROCEDURE.
THE DEVICE, INITIALLY IMPLANTED ON 2/11/94, BROKE AND REQUIRED REVISION 8/30/96.
A DEATH OCCURRED IN CONJUNCTION WITH THE USE OF THE DEFIBRILLATOR. UPON ARRIVAL AT THE SCENE, THE INSTALLED BATTERY WAS FOUND TO BE INADEQUATELY CHARGED. BATTERIES FROM THE CHARGER SYSTEM WERE OBTAINED AND FUNCTIONED CORRECTLY THROUGHOUT THE REMAINDER OF THE RESUSCITATIVE MEASURES. A MALE SAILOR REPORTED TO THE SHIP'S MEDICAL DEPT SHORTLY AFTER LUNCH COMPLAINING OF CHEST PAIN AND SOME PAIN IN HIS ARM. MEDICAL HISTORY INDICATED HIS PAINS WERE ATTRIBUTED TO A RECENT SPICY MEAL AND WEIGHT LIFTING. MEDICAL PLAN WAS TO HAVE THE PT RETURN IF HE HAD ANY SYMPTOMS OF SHORTNESS OF BREATH WITH OR WITHOUT EXERTION, RECURRENCE OF CHEST PAIN, OR RADIATING PAIN. MEMBER WAS RETURNED TO DUTY WHEN SEVERAL MINS LATER HE WAS SEEN COLLAPSING AT HIS DUTY LOCATION. WHEN THE MEDICAL SPECIALIST ARRIVED WITH A DEFIBRILLATOR/MONITOR, THE BATTERY WAS FOUND TO BE INADEQUATELY CHARGED TO PROPERLY FUNCTION. A RUNNER WAS SENT TO GET NEW BATTERIES FROM THE CHARGER SYSTEM AND THE DEFIBRILLATOR FUNCTIONED CORRECTLY THROUGHOUT THE REMAINDER OF THE RESUSCITATIVE MEASURES. RESUSCITATIVE MEASURES WERE UNSUCCESSFUL. THROUGHOUT ALL ACLS PROCEDURES THE PT NEVER HAD A PULSE AND HIS CARDIAC RHYTHM STAYED ASYSTOLE.
DEVICE WAS REMOVED FROM THE PT, DUE TO INADEQUATE RIGIDITY AND WOULD NOT INFLATE, AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WOULD NOT INFLATE-RESERVOIR COLLAPSED. ANOTHER DEVICE WAS IMPLANTED.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLEFOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON LOW IMPEDANCE. NO FURTHER INFO IS AVAILABLE.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN THE IMPLANT WAS PLACED IN CLASS III BONE IN SITE #3 DURING A COMPLEX PROCEDURE. THE CLINICAL REPORTS THAT THE SITE WAS LESS THAN IDEAL AND THE IMPLANT WAS REMOVED 4 MONTHS POST-OPERATIVELY.
IMAGES STORED ON THE DISK  DRIVE WERE LOST DURING A REVIEW PROCEDURE. SOME OF THE IMAGES FOR THE PATIENT WERE AVAILABLE FOR DIAGNOSIS AND THE STUDY WAS NOT REPEATED. THE SYSTEM WAS REPAIRED AND PLACED BACK IN SERVICE.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT PLACED 11/95 REMOVED 8/23/96. ACCORDING TO CLINICIAN, OUT OF THE FOUR IMPLANTS PLACED ONE DID NOT INTEGRATE. CLINICIAN HAS BEEN ASKED TO SEND FORMS AND PRODUCT.
MFR'S EVAL TO FOLLOW. AN ADD'L INFO REPORT WILL BE FILED AT THAT TIME.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO CLINICIAN, PT DID NOT COMPLY WITH PERIODIC EVALUATIONS AND TREATMENT. CLINICIAN TO SEND REG. FORM AND PRODUCT.
DURING SURGERY THE SHAFT OF THE REAMER BROKE AT THE POINT WHERE THE FLEXIBLE SHAFT IS ATTACHED TO THE CHUCKING SHANK. WHEN THE SURGEON TRIED TO REMOVE THE SHAFT AND REAMER, THE TWO SEPARATED. AN INCISION IN THE FEMUR WAS REQUIRED TO REMOVE THE REAMER. THIS DELAYED SURGERY FOR ABOUT 1.5 HOURS.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT APPROX ONE MONTH POST OPERATIVE.
THE ENTIRE MIDDLE PORT CAME OFF THE TPN BAG SPILLING THE CONTENTS EVERYWHERE, DURING THE INITIATION OF THE CONTINUOUS INFUSION.
ON 9/11/96, THE FACILITY NURSE CONTACTED THE MFR SALES REP TO REPORT THAT THE DEVICE WAS REMOVED AND REQUESTED THAT THE MFR SALES REP PICK-UP THE DEVICE FOR RETURN TO THE MFR FOR ANALYSIS. THE FACILITY NURSE ALSO REQUESTED THAT THE MFR SALES REP CONTACT THE PHYSICIAN AND THE PHYSICIAN STATED THAT THE DEVICE WAS "DEFECTIVE" AND THAT THE DEVICE SIDEPORT WAS "UNDONE". THE DEVICE WAS REMOVED AT THE REQUEST OF THE PT, DUE TO DISCOMFORT. UPON DEVICE REMOVAL THE PHYSICIAN NOTICED THE DEVICE SIDEPORT WAS COMPROMISED.
THE MFR SALES REP INVESTIGATED THIS INCIDENT, ON 9/12/96, WITH THE PATIENT'S ONCOLOGY OFFICE AND THE SURGEON, AND CONFIRMED THAT AN ATRIAL GRAM HAD BEEN PERFORMED THROUGH THE DEVICE SIDEPORT IN JUNE, 1996. THE PATIENT'S THERAPY TREATMENTS HAD STOPPED IN JUNE 1996 DUE TO DISEASE PROGRESSION. THE PATIENT FELT DISCOMFORT WITH THE DEVICE AND AS A RESULT THE DEVICE WAS REMOVED ON 9/11/96. UPON REMOVAL OF THE DEVICE, THE SURGEON NOTICED THAT THE DEVICE WAS COMPROMISED. THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: INITIAL VISUAL EXAMINATION REVEALED THAT THE DEVICE SEPTUM WAS DISLODGED AS RECEIVED. AFTER RESEATING THE DEVICE SEPTUM, BOTH THE CENTER AND SEPTUMS SHOWED NORMAL USAGE WITH NO INTERNAL FRACTURE PLANE DAMAGE SEEN. THE DEVICE WAS PRESSURIZED TO IT'S MAXIMUM SPECIFICATION AT 65PSI AND DID NOT BECOME DISLODGED. THE DEVICE DID DISLODGE AT 90PSI WHICH IS WELL ABOVE THE LABELED LIMITS FOR THE DEVICE. THE DEVICE DID NOT LEAK WHILE PRESSURIZING THE DEVICE OR FILLING THE RESERVOIR. THE DEVICE WAS NOT PATENT UPON PRESSURIZATION AND NO AMOUNT OF PRESSURE COULD RESTORE PATENCY. UPON PRESSURIZING, APPROXIMATELY 5MLS OF CLEAR, COLORLESS FLUID WITH AMBER PARTICLES WAS COLLECTED WHICH TESTED POSITIVE FOR BLOOD. THE DEVICE DID NOT FLOW AS RECEIVED. AFTER REMOVING APPROXIMATELY ONE INCH OF DEVICE CAPILLARY TUBING, AMBER COLORED MATERIAL WHICH TESTED POSITIVE FOR BLOOD WAS SEEN OCCLUDING THE DEVICE CAPILLARY TUBE FLOWPATH. AFTER REMOVING A TOTAL OF 13 INCHES OF DEVICE CAPILLARY TUBING, FLOW WAS RESTORED TO WITHIN ORIGINAL MFR. FLOWRATE SPECIFICATIONS. THE FACILITY'S REPORT THAT THE DEVICE SEPTUM DISLODGED HAS BEEN CONFIRMED. BASED ON THE DEVICE ANALYSIS RESULTS IT APPEARS THAT THE CAUSE OF THE DEVICE SEPTUM DISLODGEMENT IS ATTRIBUTABLE TO OVER PRESSURIZATION OF THE DEVICE. THE FACILITY WILL BE REMINDED THAT DEVICE BOLUS INJECTION RATES MUST NOT EXCEED 10 ML/MINUTE AND THE SYRINGE SIZE MUST BE LIMITED TO 10 ML OR LARGER. NO FURTHER INFORMATION IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
HEALTHCARE PROFESSIONAL REPORTS INCIDENTS OF PT REACTIONS DURING TREATMENT. PTS COMPLAINED OF FEVER, MUSCLE AND JOINT PAIN, CONJUNCTIVITIS AND DEAFNESS. THESE REACTIONS OCCURRED IN 1995 AND NO OTHER INFO IS AVAILABLE. NO SAMPLES ARE AVAILABLE EITHER. THE LOT NUMBER REPORTED WAS THE SUBJECT OF FIELD CORRECTIVE ACTION.
THE PRODUCT INVOLVED WAS THE SUBJECT OF A WORLD-WIDE RECALL NOTIFICATION INITIATED ON 10/8/94 AND CLOSED BY THE FDA ON 11/6/95. A COPY OF THE ORIGINAL RECALL NOTIFICATION AND THE LETTER FROM THE FDA CLOSING THE ACTION IS ATTACHED. REFERENCE: A-187/194-5. IT IS NOT CLEAR HOW THE REPORTER ACQUIRED THE PRODUCT INVOLVED SINCE ALL PRODUCT CAPTURED BY THE RECALL WAS DESTROYED.
DEVICE APPEARS TO HAVE BEEN MFG AND DISTRIBUTED WITHOUT A LOT CONTROL NUMBER AND WITHOUT AN EXPIRATION DATE FOR THE STERILIZATION OF THE DEVICE. ALSO, ALTHOUGH THE TYVEK POUCH ASSERTS "REFER TO DIRECTIONS FOR USE FOR DETAILED INSTRUCTIONS", NO DETAILED INSTRUCTIONS WERE PROVIDED WITH THE DEVICE.
DESCRIBE EVENT OR PROBLEM:  HIGH THRESHOLDS.
THE DIRECTORS FO CLINICAL ENGINEERING HAS DETERMINED THAT NO DEVICE RELATED ADVERSE EVENT OCCURRED. THUS THE HOSPITAL WILL NOT FILL A 3500A.
THE PATIENT EXPERIENCED PAIN. REVISION SURGERY WAS PERFORMED TO REMOVE THE TIBAL AND PATELLAR COMPONENTS.
SUMMARY OF EVALUATION: THE INFO PROVIDED AND THE EXAMINATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALIGNMENT.
TINY HOLES WERE NOTED IN THE PACKAGING INTEGRITY OF STERILE DISPOSABLE SURGICAL SUCKERS AND ADULT SUMP SUCKERS. THE PACKAGING HOLES WERE DETECTED USING AN ARTIFICIAL LIGHT SOURCE AND PASSING OF WATER THROUGH THE PACKAGE. THE ITEMS WERE INSPECTED UPON ARRIVAL IN THE FACILITY AND THEREFORE THERE IS NO QUESTION OF COMPROMISE TO THE PACKAGING AFTER RECEIPT. THE CO WAS IMMEDIATELY NOTIFIED. NO ITEM WITH QUESTIONABLE PACKAGING INTEGRITY WAS PLACED INTO CIRCULATION AFTER THE PROBLEM WAS IDENTIFIED.
THIS EVENT WAS REPORTED AS: VALVULAR HEART DISEASE CALCIFICATION. NO FURTHER INFO PROVIDED.
F1: USER FACILITY. F10. PT CODE: 2411, 1758. F12: HOSP. F13: NO. F9: UNK. F14: REFER TO D3. F2: REFER TO D3> F2: UNK. F4: UNK. F5: UNK. F6: UNK. F7: UNK. F8: UNK.
DURING USE OF THE PRODUCT, THE BALLOON RUPTURED. THE IAB WAS REMOVED AND REPLACED, AND THERE WERE NO PT COMPLICATIONS.
MFR CONTROL NO. DI96-212. THE SAMPLE WAS RETURNED FOR EVAL. A LEAK WAS FOUND IN A SLIGHTLY ABRADED AREA APPROXIMATELY 1CM IN LENGTH. THERE WAS A HOLE IN THIS ABRADED AREA MEASURING 1MM IN DIAMETER. THE LEAKAGE OCCURRED AT THE HOLE.
THE CONNECTOR WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID-LOSS RESERVOIR CONNECTOR.
ON 9/13/96, A MFR CUSTOMER SERVICE REP TRANSFERRED A CALL FROM THE FACILITY'S MANAGER, SYSTEMS & SUPPLY TO THE MFR'S MANAGER, PRODUCT COMPLAINTS & LITIGATION. THE FACILITY'S MANAGER, SYSTEMS & SUPPLY STATE THAT SHE HAD RECEIVED A DEVICE TRACKING POLLING LETTER CONCERNING A DEFECTIVE DEVICE WHICH SHE HAD TRIED TO RETURN TO THE MFR PREVIOUSLY; HOWEVER, SHE WAS ALLEGEDLY INFORMED BY SOMEONE IN CUSTOMER SERVICE THAT THIS WAS NOT POSSIBLE. THE MFR'S MANAGER, COMPLAINTS & LITIGATION ASKED THE FACILITY'S MANAGER, SYSTEMS & SUPPLY IN WHAT MANNER WAS THE DEVICE DEFECTIVE AND SHE STATED THAT SHE DID NOT KNOW. THE ONLY THING ON THE DEVICE, WHICH IS STILL IN HER INVENTORY IS A NOTE FROM AN OR NURSE WHICH STATES "DEVICE DEFECTIVE, 4/3/96." THE MFR'S MANAGER, PRODUCT COMPLAINTS & LITIGATION INFORMED HER THAT HE WOULD HAVE TO INVESTIGATE WHY THE DEVICE COULD NOT BE RETURNED AND THAT SOMEONE FROM THE MFR WOULD CONTACT HER WITH A REASON OR WITH AN AUTHORIZATION NUMBER FOR RETURN OF THE DEVICE FOR ANALYSIS.
ON 9/18/96, THE FACILITY'S MANAGER, SYSTEMS & SUPPLY INFORMED A MFR REP THAT A BIOHAZARD KIT WOULD BE NEEDED FOR RETURN OF THE DEVICE FOR ANALYSIS. ADDITIONALLY, SHE STATED THAT SHE WOULD TRY TO FIND OUT FURTHER INFO REGARDING THIS DEVICE (E.G. PHYSICIAN/NURSE NAMES AND/OR TELEPHONE NUMBER, DATE OF EVENT, PT'S NAME, CIRCUMSTANCES SURROUNDING EVENT, WHY DEVICE CONSIDERED "DEFECTIVE," ETC.). THE FACILITY'S MANAGER, SYSTEMS & SUPPLY STATED SHE WOULD ATTEMPT TO ACQUIRE THIS INFO AS SOON AS POSSIBLE AND CONTACT THE MFR'S REP WITHIN TWO (2) DAYS. ON 10/8/96, THE MFR REP CONTACTED THE FACILITY'S MANAGER, SYSTEMS & SUPPLY CONCERNING LOCATION OF THE DEVICE (THE DEVICE STILL HAD NOT BEEN RETURNED TO THE MFR TO DATE). THE FACILITY'S MANAGER, SYSTEMS & SUPPLY STATED THAT TO HER KNOWLEDGE, THE DEVICE WAS SENT ON 9/30/96, AND THE MFR SHOULD HAVE RECEIVED IT BY NOW. THE MFR REP ALSO ASKED HER IF SHE HAD ANY FURTHER INFO REGARDING THE INCIDENT. SHE STATED THAT SHE WAS UNABLE TO ACQUIRE ANY FURTHER INFO CONCERNING THE CIRCUMSTANCES SURROUNDING THIS EVENT. THE MFR REP INFORMED THE FACILITY'S MANAGER, SYSTEMS & SUPPLY THAT IF THE MFR HAS NOT RECEIVED THE DEVICE BY FRIDAY (10/11/96), SHE WOOULD CONTACT HER SO SHE CAN HAVE TRACER PUT OUT ON IT. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.
THE DEVICE WAS TAKEN OUT OF ITS PLASTIC CONTAINER AND MADE READY FOR USE ON AN ADULT PT. THE PHYSICIAN USED THE DEVICE ON THE PT AND IT CAUSED MAJOR COMPLICATIONS. THE PT HAD TO BE TREATED FOR A TENSION PNEUMOTHORAX. UPON INVESTIGATION, IT WAS FOUND THAT THE BAG PORTION OF THE DEVICE WAS INSERTED INTO THE TUBING BACKWARDS AT THE VALVE END. ALL REMAINING DEVICES HAVE BEEN INSPECTED AND THEY ARE PUT TOGETHER CORRECTLY. THE LOT NUMBER IS UNKNOWN, AS THE BAG WAS THROWN AWAY.
THIS EVENT WAS REPORTED AS: VALVULAR HEART DISEASE AND CALCIFICATION. NO FURTHER INFO PROVIDED.
F1: USER FACILITY. F10: PT CODE: 2411, 1758, DEVICE CODE: 2204. F12: HOSP. F2: UNK. F4: UNK. F5: UNK. F6: UNK. F7: UNK. F8: UNK. F9: UNK. F11: UNK.
THE PUMP WAS REPOSITIONED ONLY. NO COMPONENTS WERE REMOVED OR REPLACED.
ON 2/12/88 A MALLEABLE DEVICE WAS IMPLANTED. ON 4/11/88, THE RIGHT ROD WAS REMOVED. ON 9/6/96, THE REMAINING ROD WAS REMOVED FROM THE PT AND AN IPP DEVICE IMPLANTED BECAUSE THE LEFT PROSTHESIS WAS FRACTURED.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO MALFUNCTION SECONDARY TO FLUID LOSS FROM THE RIGHT CYLINDER.
THIS EVENT WAS REPORTED AS: REGURGITATION. NO FURTHER INFO PROVIDED.
F1: USER FACILITY. F9: 13 YEARS. F10: PT CODE: 2259. DEVICE CODE: 2204. F12: HOSP. F13: NO. F14: REFER TO D3. F2: UNK. F4: UNK. F5: UNK. F6: UNK. F7: UNK. F8: UNK. F11: UNK.
PARAMEDICS RESPONDED TO A PERSON, CONDITION NOT REPORTED. THE PT WAS CONNECTED TO THE MONITOR WITH ECG LEADS AND PACING PADS AND PACING WAS INITIATED. ACCORDING TO THE REPORTER, THE DEVICE STOPPED PACING THE PT. THE REPORTER ALSO STATED THAT NO BATTERY FAILURE WAS NOTED AT THE TIME OF THE INCIDENT. THE PT WAS NOT RESUSCITATED.
IN AN EVALUATION OF THE DEVICE BY THE LOCAL CO SERVICE REP, A COMPLETE FUNCTIONAL TEST WAS PERFORMED AND PROPER OPERATION WAS OBSERVED. THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.
IT WAS REPORTED DIFFICULTIES WERE ENCOUNTERED DURING THE DEFLATION OF A BALLOON CATHETER. THE BALLOON WAS SUCCESSFULLY DEFLATED WITH A NEEDLE AND REMOVED WITH NO PT COMPLICATIONS. NO FURTHER INFO WAS PROVIDED AND ATTEMPTS TO GAIN FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE. THIS DEVICE HAS NOT BEEN RETURNED FOR EVAL. THEREFORE, WITHOUT FURTHER INFO OR AN ENGINEERING EVAL, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. A KINK WAS NOTED IN THE INNER CATHETER SHAFT UPON EVALUATION. A PUNCTURE MARK WAS NOTED IN THE BALLOON, WHICH OUR FOLLOW UP INDICATED WAS MADE WITH A NEEDLE. THE CAUSE FOR THE DEFLATION PROBLEM REPORTED IN THE ORIGINAL COMPLAINT APPEARS TO BE DUE TO THE KINKED INNER CATHETER SHAFT. THIS TYPE OF CATHETER DAMAGE CAN RESULT IF THE BALLOON HAS BEEN INFLATED OR DEFLATED WITHOUT THE USE OF A GUIDEWIRE. THEREFORE, WE BELIEVE USER TECHNIQUE MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, SINCE NO FURTHER DETAILS COULD BE OBTAINED REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT, WE CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. THE DIRECTIONS FOR USE FOR THIS PRODUCT STATE: "NEVER INFLATE OR DEFLATE THE BALLOON WITHOUT A GUIDEWIRE IN THE CATHETER."
ON 10/3/91 DEVICE WAS IMPLANTED. ON 3/17/94 THE CYLINDERS AND PUMP WERE REVISED. ON 9/3/96 THE DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO A FAILED PROSTHESIS. ADD'L INFO RECEIVED ON 10/3/96 INDICATES FLUID LOSS FROM CYLINDER. ADD'L LOT AND SERIAL NUMBER: 4751M 015.
PT HAD A #22 FR SUPRA PUBIC CATHETER. PT'S WIFE GOT UP TO BATHE PT, PUT CATH ON LEG BAG, NOTED PT'S BED WAS WET AND CATHETER WAS OUT. UPON FURTHER INSPECTION SHE NOTED THAT THE BALLOON HAD RUPTURED CAUSING CATH TO COME OUT.
PT SCHEDULED TO HAVE A CT WITH IV CONTRAST. IV SITE WAS ESTABLISHED USING ANOTHER CO'S IV CATHETER AND THE SUSPECT EXTENSION SET. THE IV SITE WAS FLUSHED WITH NORMAL SALINE AND CLAMPED. THE CONTRAST WAS TO BE ADMINISTERED VIA THE AUTO INFUSOR. THE IV CONTRAST SOLUTION WAS CONNECTED TO THE EXTENSION SET AND UNCLAIMED. THE AUTO INFUSOR WAS STARTED AND THE SOLUTION RAN ALL OVER THE PT AND CT TABLE. UPON INSPECTION IT WAS FOUND THAT THE SPOT WHERE THE CLAMP HAD BEEN USED TO OPEN AND CLOSE THE SYSTEM HAD CUT THE TUBING.
THIS EVENT WAS REPORTED AS SMALL CUSP PERFORATION IN ONE LEAFLET, CALCIFICATION IN LEAFLETS AND "DEGENERATION OF TISSUE". NO FURTHER INFO PROVIDED.
A STENT PROCEDURE WAS INITIALLY PERFORMED WITHOUT INCIDENT. APPROX. TWO WEEKS POST PLACEMENT, THE PT EXPERIENCED FLANK PAIN. CAUDAD MIGRATION WAS NOTED DURING A KUB. THE STENT WAS REMOVED WITHOUT INCIDENT. THERE WERE NO PT COMPLICATIONS INVOLVED. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED BY THIS MFR. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. THE DIRECTIONS FOR USE STATE: "A STENT OF PROPER LENGTH SHOULD BE AVAILABLE. IDEALLY, THE UPPER COIL SHOULD LIE WITHIN THE RENAL PELVIS WHILE THE LOWER COIL RECURVES AT THE URETERAL ORIFICE."
H3-THE DEVICE HAS NOT YET BEEN RECEIVED BY THE MFR.
THE PROSTHESIS "ERODED". NO ADD'L INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICEOR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES.
ON 9/13/96, THE PHYSICIAN CONTACTED A MFR NURSE AND REPORTED THE PT COMPLAINED OF SUDDEN PAIN, SAME PAIN AS BEFORE THE DEVICE WAS IMPLANTED. THE PT PAIN HAS BEEN WELL CONTROLLED FOR OVER 1.5 YEARS. THE PT WAS ADMITTED TO THE HOSP FOR PAIN MANAGEMENT. THE PHYSICAIN INFORMED THE MFR NURSE THAT HE WOULD PERFORM A DYE STUDY TO DETERMINE DEVICE CATHETER PLACEMENT. THE MFR NURSE REVIEWED DEVICE SIDEPORT CAUTIONS AND FAXED THE PHYSICIAN DEVICE REFILL INSTRUCTIONS AND BOLUS PROCEDURE. IN ADDITION, THE MFR NURSE MAILED THE PHYSICIAN ADD'L INFO CONCERNING THE DEVICE. THE PHYSICIAN WHO MANAGED THE DEVICE IN THE PAST, HAS LEFT THE AREA.
ON 10/23/96, THE MFR'S CLINICAL REP. WAS INFORMED BY THE FACILITY'S NURSE THAT THE MORPHINE SULFATE DOSE WAS INCREASED. THE PATIENT WAS DOING MUCH BETTER AND THEY WILL CONTINUE TO USE THIS THERAPY. ON 11/1/96, THE FACILITY NURSE INFORMED A MFR REP. THAT SINCE THE PATIENT'S MORPHINE CONCENTRATION WAS INCREASED TO 6 OR 7 MG/ML (SHE DID NOT HAVE THE PATIENT'S CHART AT HAND SO SHE WAS NOT SURE OF THE EXACT DOSAGE), THE PATIENT HAS NOT COMPLAINED OF ANY PAIN BREAKTHROUGH AND APPEARS TO BE RECEIVING ADEQUATE PAIN RELIEF. ADDITIONALLY, THE FACILITY NURSE STATED THAT THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN. SINCE THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT ID. A REVIEW OF THE DEVICE HISTORY RECORD DI DNOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT FOR THIS DEVICE. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY TO THE DEVICE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. HOWEVER, THE 90 DEGREE KINK THAT WAS NOTED IN THE INTRATHECAL CATHETER AT THE ENTRANCE TO THE SPINE MAY BE CONTRIBUTING TO TEH SLOW FLOW RATE OF THE DEVICE. NOTE: INTRATHECAL INFUSION OF MORPHINE WAS NOT MFR'S INDICATION FOR THE DEVICE'S INTENDED USE. ALTHOUGH NOT PART OF THE MFR'S ORIGINAL OCTOBER 1992 DEVICE SAFETY ALERT, INSTRUCTIONS PROVIDED IN THE ALERT GUIDELINES APPLY TO THIS DEVICE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
SET LEAKING WHEN INFUSING TPN AND ANTIBIOTICS. THIS WAS THE 2ND OCCURRENCE FOR THIS PT. OTHER PTS HAVE ALSO REPORTED THAT SETS LEAK.
THIS EVENT WAS REPORTED AS "DEGENERATION". STENOSIS AND 4+ AORTIC INSUFFICIENCY. NO FURTHER INFO PROVIDED.
LEAK CAUSED BY EAR AGAINST STIFFENER. LEAK CAUSED BY WEAR AGAINST STIFFENER AND COMPRESS.
TPN PT FOUND THAT THE SOLUTION HAD NOT INFUSED DURING THE NIGHT AS INTENDED. UPON INVESTIGATION IT WAS LEARNED THAT THE PT HAD NOT COMPLETED THE DUAL RESET PRIOR TO STARTING THE CYCLE. "REMINDER LABEL" WAS AFFIXED TO THE PUMP.
THE PT EXPERIENCED PAIN. REVISION SURGERY WAS PERFORMED TO REMOVE THE TIBIAL AND PATELLAR COMPONENTS.
SUMMARY OF EVALUATION: THE INFO PROVIDED AND THE EXAMINATION RESULTS  SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALIGNMENT.
H3: EXAMINATION OF THE VALVE IN CO'S LABORATORY REVEALED DELAMINATED CIRCULAR & V-SHAPED DISRUPTIONS IN EACH CUSP WHICH ALIGNED WITH SUTURE TAILS ON THE SEWING RING WHEN THE LEAFLETS WERE FLEXED OPEN. THE REMNANT SUTURE DISPLAYED SEVERAL KNOTS WHICH RESULTED IN ELONGATED PROJECTIONS ALLOWING FOR CONTACT WITH THE TISSUE. HOST TISSUE OVERGROWTH FUSED BOTH COMMISSURES OF THE RIGHT - CORONARY CUSP WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA. X-RAY ANALYSIS REVELAED NO APPARENT CALCIFICATION. INWARD DISPLACEMENT OF BOTH STENT POSTS OF THE NONCORONARY CUSP WAS ALSO NOTED & APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO LEAFLET DISRUPTION DUE TO SUTURE ABRASION. H6: 86= X-RAY.
THIS EVENT WAS REPORTED AS EXERTIONAL SHORTNESS OF BREATH, LEAFLET DISRUPTIONS, CONGESTIVE HEART FAILURE, CLASS II, & LV ENLARGEMENT.
THE POLYETHYLENE INSERT COMPONENT OF THE ACETABULUM PROSTHESIS BROKE. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. D.6. THE EXACT SIZE AND MANUFACTURING LOT NUMBER ARE UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO.
A REVISION SURGERY WAS PERFORMED BEACUSE THE DEVICE WOULD NOT INFLATE-PUMP REPOSITIONED. NO COMPONENTS WERE REMOVED OR REPLACED.
TWO BALLOONS RUPTURED DURING A COMMON ILIAC DILATATION PRIOR TO STENT PLACEMENT OF AN EXTREMELY CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PT COMPLICATIONS. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. SINCE CO'S FOLLOW UP INDICATED THESE DEVICES WERE USED IN A CALCIFIED LESION, CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICES. HOWEVER, WITHOUT EVALUATION OF THE DEVICES, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON, THESE BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC. VASCULAR GRAFTS. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
THE DEVICE WAS APPLIED DURING A THORACOSCOPIC BULLECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON RESECTED THE STAPLE LINE WITH ANOTHER DEVICE.
10/28/96 - SUPPLEMENTAL REPORT #1 SUBMITED TO FDA BY MFG. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
ON 7/1/83 DEVICE WAS IMPLANTED. ON 10/17/84 THE PUMP AND CYLINDERS WERE REVISED. ON 9/3/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION-BOTH CYLINDERS.
THIS EVENT WAS REPORTED AS REGURGITATION. NO FURTHER INFO PROVIDED.
THE TOTAL HIP WAS REVISED IN JULY FOR UNK REASONS.
SUMMARY OF EVALUATION: THE INFORMATION PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THIS EVENT WOULD BE ASSOCIATED WITH THE DEVICE.
AN AUS DEVICE WAS IMPLANTED, DETAILS UNKONWN. ON 4/23/96, A CUFF WAS REMOVED FROM THE PT, REASON WAS NOT PROVIDED. UNABLE TO OBTAIN ADD'L INFO.
THE PT PRESENTED WITH LOSS OF RANGE OF MOTION. DURING QUADRICEP RELEASE, THE TIBAL INSERT WAS REVISED FROM 13MM TO A 16MM INSERT.
THIS IS THE SAME PT/EVENT AS MFR#2219689-1996-00129.ADDITIONAL INFORMATION PERTAINING TO THE SECTION F INFORMATION WAS REQUESTED FROM THE USER FACILITY. THE INFO IS NOT AVAILABLE.ALL SECTION F INFO REFERENCED IN THIS REPORT WAS PROVIDED BY THE MFR.WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO PAIN, PT DISSATISFACTION DUE TO LENGTHENING OF CYLINDERS.
THE DEVICE WAS APPLIED DURING A LOBECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT CUT OR STAPLE PROPERLY. THE SURGEON RESECTED TISSUE AND MANUALLY SUTURED TO COMPLETE THE PROCEDURE.
10/10/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
RPTR C/O: PAIN &/OR BURNING SENSATION IN CHEST, CHRONIC DIARRHEA &/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, HYSTERECTOMY, FREQUENT MIGRAINES/SEVERE HEADACHES, HYPERSENSITIVITY TO CHEMICALS, MOLDS DUST OR POLLEN, UNUSUAL CHRONIC INFECTIONS, INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, CHRONIC UNEXPLAINED MUSCLE SPASMS, FROZEN SHOULDER, MUSCLE PAIN & BURNING, MUSCLE ATROPHY, FIBROMYALGIA, UNEXPLAINED RASHES, SUN SENSITIVITY, UNEXPLAINED SEVERE ITCHING, CHRONIC INSOMNIA, NON-RESTORATIVE SLEEP, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICONOMAS, CLUMSINESS/DROPS THINGS AND CAPSULAR CONTRACTURES.
TRANSFERRING PT FROM BED TO CHAIR WHEN PT SLIPPED AND FELL. PT SUFFERED A FRACTURE OF LEFT FEMER, AND WAS HOSPITALIZED. ONE PERSON INVOLVED AND INJURED.
UPON INSPECTION THE DEVICE WAS FOUND TO BE IN PROPER WORKING ORDER. IT WAS DISCOVERED THAT THE CNA HOOKED THE SLING LEGS OVER THE TOP OF THE RESIDENT'S LEGS AND NOT UNDER. WHEN THE CNA RAISED THE HANGER BAR ASSEMBLY THE RESIDENT SLID OUT ONTO THE FLOOR. CAUSE OF EVENT IS USER ERROR. CUSTOMER HAS BEEN INSTRUCTED TO REVIEW THE OPERATIONAL MANUAL FOR PROPER OPERATION OF THE DEVICE. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. ADD'L INFO PROVIDED AFTER 15 DAY REPORT? N. DISCLAIMER: THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21CFR600,803, 1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
ON 10/27/92 DEVICE WAS IMPLANTED. ON 2/9/93 THE PUMP WAS REVISED. ON 5/12/95 CONNECTORS WERE REVISED. ON 1/3/96 THE PUMP WAS REMOVED. ON 7/8/96 THE PUMP WAS REIMPLANTED. ON 8/96 DAY NOT INDICATED, THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT AND SERIAL NUMBER: CB599 009.
PHOTO THERAPY LAMP FELL BARELY MISSING THE PT'S HEAD. UPON EXAMINATION IT WAS FOUND THAT A PART INSIDE THE ARM BROKE, ALLOWING ARM ASSEMBLY TO FALL.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT OPEN. THE SURGEON RESECTED TISSUE TO FREE THE DEVICE.
THE LEFT CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO MALFUNCTION-LEFT CYLINDER NOT RIGID WHEN INFLATED.
THE PT PRESENTED TO THE DR'S OFFICE AFTER SUSTAINED A FALL. RADIOGRAPHS REVEALED POLYETHYLENE WEAR OF THE ACERABULAR LINER. THE CUP WAS WELL FIXED; THEREFORE, ONLY THE LINER WAS REVISED AT THIS TIME. THE FEMORAL HEAD COMPOINENT WAS ALSO REMOVED AND REPLACED AT THIS TIME.
SUMMARY OF EVALUATION: THE ONE PIECE ACETABULAR COMPONENT AND THE FEMORAL HEAD COMPONENT WERE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE INFO PROVIDED IN CONJUNCTION WITH THE INSERT EVALUATION RESULTS WOULD SUGGEST THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE BUT RATHER WOULD BE PT RELATED. THE PT'S FALL WAS MOST LIKELY THE CONTRIBUTING FACTOR FOR THE POLYETHYLENE DAMAGE AND SUBSEQUENT REVISION SURGERY.
THE ACETABULAR COMPONENT OF THE TOTAL HIP PROSTHESIS WAS REMOVED DUE TO INSTABILITY AND DISLOCATION. NO OTHER INFO WAS PROVIDED TO CO.
INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. D.6. THE METAL SHELL COMPONENT, CATALOG NUMBER 1246-54-000; LOT NUMBER 450590, WAS ALSO RETURNED, BUT WAS NOT BELIEVED TO HAVE DIRECTLY CONTRIBUTED TO THE EVENT.
THE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AT RIGHT CYLINDER AND REPLACED.
PUMP PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A FATIGUE LEAK. TUBING WAS FUNCTIONAL.
THE ENTIRE WAS REMOVED FROM THE PT AND REPLACED DUE BROKEN TUBING. ADD'L LOT AND SERIAL NUMBER: 4211J 007.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD OR DAMAGE. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL.
TUBE PLACEMENT QUESTIONED WHEN CHECKED BY NURSE. UPON FURTHER EXAMINATION, NOTICED TUBE HAD BEGUN TO COME OUT. NURSE REMOVED TUBE FROM PT WITH NO RESISTANCE AND UPON REMOVAL NOTICED THAT THE TUNGSTEN-WEIGHTED TIP WAS BROKEN OFF. THE TUBE WAS DISCOLORED AT THE END, AND THE WEIGHTED TIP WAS BROKEN OFF. THE PT WAS X-RAYED AND THE TIP WAS IN THE STOMACH.
THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION. REPORTEDLY, THE INSTRUMENT WOULD NOT OPEN. THE SURGEON RESECTED TISSUE TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.
11/21/96-SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6. ADDITIONAL DATA ENTERED IN D7, D8, D9 AND E1(ADDRESS AND PHONE#).
PUMP PERFORMED WITHIN SPECS. BALLOON PERFORMED WITHIN SPECS. CUFF PERFORMED WITHIN SPECS.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED BECAUSE "IT DID NOT FUNCTION ANY LONGER". ADD'L LOT/SERNO: 8824K 018.
ON 4/17/96 DEVICE WAS IMPLANTED. ON 8/14/96 THE PUMP WAS REPOSITIONED. ON 9/4/96 THE DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO INFECTION. ADD'L LOT AND SERIAL NUMBER: BK779 002.
THE GUIDEWIRE USED FOR CENTRAL LINE PLACEMENT BECAME HUNG UP IN THE APEX OF A PREVIOUSLY SUCCESSFULLY DEPLOYED FILTER. RESISTANCE WAS ENCOUNTERED DURING REMOVAL ATTEMPTS AND CONTINUAL EXERTION RESULTED IN FREEING THE WIRE, HOWEVER, THE FILTER WAS DISLODGED BY THIS MANEUVER. THE FILTER WAS SUCCESSFULLY REMOVED UTILIZING A SNARE AND A SECOND FILTER SUCCESSFULLY PLACED. THIS DEVICE WAS DESTROYED BY THE USER FACILITY. THEREFORE, NO ENGINEERING EVAL WILL BE AVAILABLE. CO'S FOLLOW UP INDICATED THAT THE CENTRAL LINE WAS NOT PLACED UNDER FLUOROSCOPIC VISUALIZATION. THE FILTER REFERENCED IN THIS REPORT HAD BEEN SUCCESSFULLY PLACED SEVERAL DAYS PRIOR TO THIS EVENT WITHOUT COMPLICATIONS. NO MALFUNCTION OF THE DEVICE WAS REPORTED. RATHER, GUIDEWIRE PLACEMENT FOR A CENTRAL LINE RESULTED IN COMPLICATIONS THAT LED TO THIS EVENT.
INFO RECEIVED ON 9/9/96 INDICATES THE AUS DEVICE WOULD NOT ACTIVATE. A REVISION SURGERY HAS BEEN SCHEDULED 9/13/96. INFO RECEIVED ON 9/24/96 INDICATES THE PUMP WAS REMOVED FROM THE PT AND REPLACED ON 9/20/96.
PUMP POPPET RELEASE PRESSURE NOT WITHIN SPECS.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--WENT FLAT.
PHYSICIAN ALLEGES PT HAS BEEN BOTHERED PROGRESSIVELY WITH SEVERE PAIN AND DISCOMFORT IN HER BREASTS SECONDARY TO BREAST CAPUSLITIS. HER IMPLANTS HAVE CHANGED POSITION AND SIZE AND THE QUESTION OF THE INTACTNESS IS DOUBTFUL. HER BREASTS ARE NODULAR, TENDER AND DEFORMED IN APPEARANCE AND THESE CHNAGES HAVE ALL BEEN PROGRESSIVE AND GETTING WORSE. OPERATIVE REPORT SHOWS THE PT HAD A TOTAL CAPUSLECTOMY PERFORMED AND THE IMPLANTS WERE REMOVED AND BOTH WERE FOUND WITH THE OUTER LUMEN NOT INTACT. PT ALLEGES IN 3/95 SHE HAD A HARD MASS IN RIGHT PECTORAL MUSCLE AND HAD REMOVED AS AN OUTPATIENT. PHYSICIAN THOUGHT IT WAS SILICONE MATTER FROM PREVIOUS IMPLANTS THAT HAD FORMED THE MASS.
PT ALLEGES RECEIVING IMPLANTS IN 1985 FROM AN UNK MFR. PT ALSO ALLEGES HER IMPLANTS WERE LEAKING; THEREFORE, SHE HAD THEM REMOVED IN 1990 AND HAD REPLACEMENTS OF AN UNK MFR. PHYSICIAN ALLEGES PT HAD BEEN BOTHERED WITH SEVERE PAIN AND DISCOMFORT IN HER BREASTS SECONDARY TO BREAST CAPSULITIS. HER IMPLANTS HAVE CHANGED IN POSITION AND SIZE AND THE QUESTION OF THE INTACTNESS IS DOUBTFUL. HER BREASTS ARE NODULAR, TENDER AND DEFORMED IN APPEARANCE AND THESE CHANGES HAVE ALL BEEN PROGRESSIVE AND GETTING WORSE. OPERATIVE REPORT SHOWS THE PT HAD A TOTAL CAPSULECTOMY PERFORMED AND THE IMPLANTS WERE REMOVED AND BOTH WERE FOUND WITH THE OUTER LUMEN NOT INTACT. PT ALLEGED IN 3/95 SHE HAD A HARD MASS FOUND IN RIGHT PECTORAL MUSCLE AND HAD REMOVED AS AN OUTPATIENT. PHYSICIAN THOUGHT IT WAS SILICONE MATTER FROM PREVIOUS IMPLANTS THAT HAD FORMED THE MASS.
(IAB S/N U0000461) THE IAB WAS INSERTED INTO THE PT ON 9/5/96. ON 9/9/96 AFTER IABP FOR FOUR DAYS, "CHECK IAB CATH" ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE TUBING. THE IAB "CLOTTED" IN THE PT'S ARTERY SO THE PT WENT TO SURGERY TO HAVE THE IAB REMOVED. NO SECOND WAS INSERTED.
SECTION F WAS ALSO COMPLETED BY THE MANUFACTURER IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE LABEL CODES: 1738, 1746. EVALUATION: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBABLY CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECTED TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY. THE PHYSICIAL EVIDENCE AND REPORTED PROBLEM ARE CONSISTANT WITH THAT OF AN IAB WHICH BECAME ENTRAPPED AND WAS SURGICALLY REMOVED FROM THE PT. THE SMOOTH-EDGED PENETRATION(S) MOST LIKELY RESULTED WHEN THE BALLOON MEMBRANE CAME IN CONTACT WITH A SHARP-EDGED INSTRUMENT DURING THE REMOVAL PROCESS. ALTHOUGH THE PT CONSEQUENCES OF BALLOON PENETRATION REMAIN OVERWHELMINGLY BENIGN, GENERALLY NECESSITATING ONLY THE REMOVAL OF THE BALLOON AND IT POSSIBLE REPLACEMENT, THE MEDICAL COMMUNITY IS BECOMING INCREASINGLY AWARE OF THE "ENTRAPPED BALLOON" PHENOMENON. SINCE IT IS POSSIBLE FOR A SMALL LEAK TO BE SELF LIMITING, THE BLOOD WITHIN THE BALLOON MAY DEHYDRATE UNDER THE CONTINUED ACTION OF HELIUM TO FORM A HARD CLOT DURING INTRA-AORTIC BALLOON PUMPING, BEFORE ENOUGH BLOOD ENTERS TO BECOME VISIBLE IN THE CATHETER. THIS CLOT MAY PREVENT PERCUTANEOUS REMOVAL OF THE BALLOON CAUSING IT TO BERCOME "ENTRAPPED" IN THE ARTERY. BALLOON ENTRAPMENT NECESSITATING SURGICAL REMOVAL HAS BEEN REPORTED IN LITERATURE AND HAS BEEN EXPERIENCED BY USERS OF INTRA-AORTIC BALLOONS. CO THEREFORE URGE THE USER, AS CO HAS DONE IN THE INSTRUCTIONS, TO DISCONTINUE PUMPING AND CONSIDER THE REMOVAL OF THE BALLOON FORM THE PT AT ONCE IF A BALLOON LEAK IS SUSPECTED. IF FOR ANY REASON, UNDUE RESISTANCE IS MET DURING REMOVAL OF THE BALLOON, THE USER WOULD BE WELL ADVISED TO CALL FOR A VASCULAR CONSULTATION, AS WAS DONE IN THIS CASE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO SMALL PINPOINT LEAK FOUND IN RESERVOIR AT AREA OF FOLD.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES.
THE BALLOON WAS REMOVED FROM THE PT, DUE TO RECURRING INCONTINENCE AND FLUID LOSS, AND REPLACED.
DEVICE WAS AREMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS--LEFT CYLINDER, ANEURYSM RIGHT CYLINDER.
A GUIDEWIRE USED FOR JUGULAR CENTRAL LINE PLACEMENT BECAME HUNG UP IN THE APEX OF A PREVIOUSLY DEPLOYED FILTER. RETRIEVAL UTILIZING A FEMORAL APPROACH WAS SUCCESSFUL WITHOUT ANY PT COMPLICATIONS. CO'S FOLLOW UP INDICATED THAT THE CENTRAL LINE WAS NOT PLACED UNDER FLUOROSCOPY. THE FILTER REFERENCED IN THIS REPORT HAD BEEN SUCCESSFULLY PLACED SEVERAL DAYS PRIOR TO THIS EVENT WITHOUT COMPLICATIONS. NO MALFUNCTION OF THE DEVICE WAS REPORTED. RATHER, GUIDEWIRE PLACEMENT WITHOUT FLUROSCOPIC VISUALIZATION FOR A CENTRAL LINE RESULTED IN COMPLICATIONS THAT LED TO THIS EVENT.
ON 5/7/91 DEVICE WAS IMPLANTED. ON 12/02/94 THE PUMP WAS REVISED. ON 7/26/96 THE PUMP AND CYLINDERS WERE REVISED. ON9/3/96 THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS TUBING RESERVOIR.
DEVICE WAS REMOVED FROM THE PT, NO REASON FOR SURGERY PROVIDED. UNABLE TO OBTAIN ADD'L INFO.
PT ALLEGES SHE RECEIVED IMPLANTS OVER TWENTY YEARS AGO FROM AN UNK MFR. PT ALSO ALLEGES HER IMPLANTS HAVE BECOME HARD, MISSHAPEN AND NEED TO BE REMOVED OR REPLACED.
THE DEVICE WAS REMOVED FROMT HE PT BECAUSE IT WOULD NOT STAY INFLATED. ANOTHER DEVICE WAS IMPLANTED.
THE DOCTOR REPORTEDLY OBSERVED A CORNEAL BURN FOLLOWING A ROUTINE PHACOEMULSIFICATION PROCEDURE. THE DOCTOR USED TWO DIFFERENT HANDPIECES DURING THE DAY AND DOES NOT KNOW WHICH ONE WAS INVOLVED IN THE EVENT.
INFORMATION IN SECTION F IS PROVIDED BY THE MFR. H6 - 82, PERFORMED TEMPERATURE TEST ONLYH3. EVALUATION SUMMARY: A TEMPERATURE RISE PROFILE WAS PERFORMED ON BOTH HANDPIECES AND THE PRODUCT WAS FOUND TO BE FUNCTIONING WITHIN THE NORMAL RANGE. NO ANOMALIES WERE DETECTED IN THE HANDPIECE WHICH WOULD HAVE CONTRIBUTED TO THE CORNEAL BURN.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND SHEARING OF THE PATELLA PEGS.
SUMMARY OF EVALUATION: THE TIBIAL INSERT AND PATELLAR COMPONENT CAN NOT BE EVALUATED FOR THE REPORTED WEAR AND PEG SHEARING OF THE PATELLAR PEGS AS THEY HAVE NOT BEEN RETURNED TO HOWMEDICA, BUT RATHER HAVE BEEN RETAINED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INSERT FOUND NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE LOT CODE OF THE PATELLAR COMPONENT HAS NOT BEEN SUPPLIED SO THAT A REVIEW OF ITS DEVICE HISTORY RECORD IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THIS LOT CODE INFO AND THE DEVICE HAVE BEEN UNSUCCESSFUL.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECS. BALLOON HAD A WEAR LEAK.
PT RECEIVED IMPLANTS IN AUGUST 1975. REPORTER ALSO ALLEGES THAT PT'S IMPLANTS HAD A PIN HOLE AND WERE LEAKING; THEREFORE, SHE HAD REMOVAL ON SEPT. 11, 1996.
METHOD: 86B WEIGHT MEASUREMENT. RESULTS: 100 WEIGHT PACKAGING AND DEVICE; 100C SLIGHT AMBER COLOR; 100H LOSS OF SHELL INTEGRITY, ENVELOPE TEAR; 100G CLOUDY; 100J FOREIGN MATERIAL IN GEL; 100K AMBER COLOR. DEVICE 1 OF 2 CONCLUSIONS: 68 NO RESULTS SUPPORTED THE ALLEGED REASON OF "LUMP(S)"; AMBER COLOR CONDITION OF AGING; CLOUDINESS CAUSE UNDETERMINED. DEVICE 2 OF 2 CONCLUSIONS: 68 NO RESULT SUPPORTED THE ALLEGED REASON OF "DISFIGURED APPEARNACE"; COLOR WITHIN SPECIFICATION; CAUSE OF TEAR(S) UNDETERMINED; FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO PAIN AND LEAKING (INCONTINENCE).
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION AND EROSION OF TUBING AT SCROTUM.
THREE BALLOONS RUPTURED ON THE FIRST INFLATION DURING A DILATATION OF AN ARTERIOVENOUS HEMODIALYSIS FISTULA GRAFT. DURING WITHDRAWAL OF THE THIRD BALLOON CATHETER FOLLOWING BALLOON RUPTURE, THE BALLOON MATERIAL DETACHED FROM THE CATHETER SHAFT. FOLLOW UP INDICATED AN INTRODUCER SHEATH WAS NOT UTILIZED FOR BALLOON EXCHANGES. RETRIEVAL OF THE BALLOON MATERIAL WAS UNEVENTFUL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS. TO DATE, THE DEVICES HAVE NOT BEEN RECEIVED BY THS MFR. THEREFORE, NO FAILURE ANALYSIS WAS PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. IT WAS ALSO INDICATED AN INTRODUCER SHEATH WAS NOT UTILIZED TO PROTECT THE VESSEL AND PRODUCT DURING WITHDRAWAL. CO BELIEVES THE ABOVE FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICES. HOWEVER, WITHOUT EVALUATING THE DEVICES, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY. WHEN INSERTING A CATHETER THROUGH A BADLY SCARRED AREA, USE OF AN INTRODUCER SHEATH IS RECOMMENDED."
H3-DEVICE HAVE NO YET BEEN RECEIVED BY THIS MFR.
PT RECEIVED BREAST IMPLANTS ON AN UNKNOWN DATE AND OF AN UNKNOWN MFR. REPORTER ALSO ALLEGES PT HAD CANCER.
H3 - ADDITIONAL INFO RECEIVED CONFIRMS PATIENT'S IMPLANTS WERE NOT MFR BY DOW CORNING.
THE CO DEVICE WAS REMOVED FROM THE PT DUE TO A "MALFUNCTION". ANOTHER DEVICE WAS IMPLANTED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L SERIAL #: AO076 007. ADD'L LOT #: AO076 007.
ON 1/29/96, AN AUS DEVICE WAS IMPLANTED. ON 6/20/96, THE BALLOON WAS REVISED. ON 9/3/96 THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION-DEEP BULBOUS URETHRA.
DURING PROCEDURE PENCIL QUIT WORKING. CHANGED OUT DEFECTIVE HANDPIECE FOR NEW ONE. NEW ELECTROCAUTERY PENCIL DID NOT WORK EITHER.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED BECAUSE PT NEEDED A SMALLER CUFF.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 9/30/80. SHE ALSO ALLEGES HAVING EXPERIENCED PROBLEMS WITH CO IMPLANTS IN 1994 AND SHE IS CONCERNED ABOUT RELATED PROBLEMS. PHYSICIAN ALLEGES PT IS CONCERNED ABOUT PROSTHESIS-WANTS REMOVED.
DOCTOR REPORTS LENS REPLACEMENT DUE TO KERATOPLASTY WHICH HE IMPLIES IS LENS RELATED. HE REPORTS HE SAW PT FOR THE FIRST TIME IN THE SPRING OF 1996 WITH PSEUDOPHAKIC BULLOUS KERATOPATHY.
THIS FORM CONTAINS ALL THE INFO WHICH WAS SUPPLIED BY THE REPORTER. THE RETURNED LENS WAS EVALUATED TO HAVE BOTH HAPTICS BROKEN IN THE GUSSET AREA WHICH COULD HAVE BEEN DONE IN ORDER TO REMOVE THE LENS EASILY. THE LENS WAS EXPLANTED DURING THE TRANSPLANTATION OF THE PT'S CORNEA. THE MFR'S INTERNAL REFERENCE NUMBER IS 96L4900. THIS REPORT WAS MAILED IN TO FDA ON: 10/07/96. DISCLAINER: THIS INFO IS SUBMITTED PURSUANT TO 21 CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN  ADMISSION THAT AN CO PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED = 1.
INFO RECEIVED ON 10/31/96 INDICATES THE DEVICE WAS REMOVED FROM THE PT IN 12/95, DUE TO INFECTION. ADD'L LOT AND SERIAL NO: 0692W 010
ATTORNEY ALLEGES "SON OF CLIENT DIED AS A RESULT OF CARDIAC ARREST AND ACUTE PULMONARY EDEMA." FOUR YEARS PRIOR TO DEATH A PACEMAKER WAS IMPLANTED.  "... DESPITE INTENDED PURPOSE OF PACEMAKER, AS A RESULT OF DEFECTS AND DESIGN FLAWS, THE PACEMAKER FAILED TO FUNCTION PROPERLY AND PT DIED." REF - 2649622-1996-0005.
INTERNAL NUMBER IS 650748. EVENT INCLUDED IN LABELING. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER.
PT CONTRACTED GRAM NEGATIVE PSEUDOMONAS MENINGITIS AFTER SURGERY AND HAD TO BE HOSPITALIZED. ALTHOUGH THE OR STAFF DID NOT ISOLATE THIS TRAY AS A SINGLE CAUSATIVE FACTOR, THEY ARE REPORTING ALL PRODUCTS USED DURING THE PROCEDURE AS SUSPECTS FOR THE REPORTED INFECTIONS CASE.
CODE 81-INVESTIGATION IS IN PROGRESS. REFERENCE MR. COMPLAINT #K96-9-11-82. PLEASE  NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
ON 2/24/83 AN AUS DEVICE WAS IMPLANTED. ON 5/5/83 THE DEVICE WAS ACTIVATED. ON 7/22/88 THE PUMP WAS REVISED. ON 9/9/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
PUMP PERFORMED WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON HAD A FATIGUE LEAK.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT DUE TO EROSION.
FINGER JOINT PROSTHESIS REMOVED DUE TO IMBALANCED JOINT.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO ATROPHY AROUND THE CUFF.
IMPLANT PLACED 2/5/96. HEALING ABUTMENT PLACED 6/25/96. ABOUT A MONTH AGO, PT CAME IN AND IMPLANT WAS OUT. OTHER IMPLANT IN THIS PT IS FINE.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. THE PROBABLE CAUSES OF FAILURE ARE THE PT'S HYPERTENSION AND ALLERGIES, WHICH INCLUDE PENICILLIN AND ASPIRIN.
THE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AND REPLACED.
THE PT WAS IMPLANTED BILATERALLY WITH SALINE PROSTHESIS ON 8/16/93. SUBSEQUENTLY THE DOCTOR NOTED THAT THE PATIENTS LEFT BREAST DEVELOPED CAPSULAR CONTRACTURE AND HER RIGHT BREAST DEVELOPED A SEROMA AND CAPSULAR CONTRACTURE.  NO ADDITIONAL INFORMATION REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N IF "NO" IS EVENT OCCURING MORE FREQ THAN USUAL FOR PRODUCT? U IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y IF "YES" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N T3IS REPORT WAS SUBMITTED TO THE FDA PERSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (MENTOR EFFECTIVE DATE, FEB. 10, 1992). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21CFR803."SUBMISSION OF THIS RPT BY MENTOR H/S IS PURSANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFORMATION CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS RPT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO.
THE CENTER TOOK APPROX SIX X-RAYS OF PT'S LOWER BACK. PT WAS TOLD TO LAY ON HIS BACK ON THE MACHINE TABLE DURING THIS PROCEDURE. 2 DAYS LATER, TWO CIRCULAR BURNS, APPROX THE SIZE OF A DIME, APPEARED ON HIS BACK. PRIMARY CARE PHYSICIAN AND THE X-RAY CTR ASSURED RPTR THAT IT WAS IMPOSSIBLE FOR THE X-RAY DEVICE TO CAUSE THESE BURNS. AFTER SURFING THE INTERNET RPTR FOUND THAT IT IS VERY POSSIBLE.
THREE IMPLANTS WERE PLACED. ALL FAILED DUE TO INFECTION, PAIN, SWELLING. ACTIVE PUS DRAINAGE OCCURRED.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. THE PT'S INFECTION IS THE PROBABLE CAUSE OF FAILURE. THE OTHER 2 IMPLANTS THAT FAILED AT THE SAME TIME WERE NOT CO IMPLANTS.
PHYSICIAN REPORTS LENS REMOVAL DUE TO INFLAMMATION APPROX 10 MOS AFTER INITIAL IMPLANT. HE REPORTS LENS WAS IMPLANTED 6/95. IN 10/95 A RETINAL TEAR WAS OBSERVED OS AND LASER TREATMENT WAS PERFORMED. THE PT WAS REFERRED TO A SPECIALIST FOR GLAUCOMA EVALUATION. AT THIS TIME THE PT WAS NOTED TO HAVE 2+ CELLS, 3+ FLARE, ANTERIOR CHAMBER HEME, AND PERSISTENT EPITHELIAL DEFECT. IN 2/96 DIODE LASER TREATMENT WAS USED OS FOR CPC. ON 4/15/96 THE LENS WAS REMOVED, AND AN ANTERIOR VITRECTOMY PERFORMED, AND SUBTENON INJECTIONS INSTALLED. THE PT IS REPORTED TO BE DIABETIC, HAS NEOVASCULAR GLAUCOMA, RUBEOTIC GLAUCOMA, HEME IN ANTERIOR CHAMBER, CORNEAL STAINING AND A HISTORY OF RETINAL DETACHMENT OS. ON 6/17/96 THE PT WAS OBSERVED TO HAVE NO LIGHT PERCEPTION OS.
THE MANUFACTURER'S INTERNAL REFERENCE NUMBER IS 96L3608. THIS REPORT WAS MAILED IN TO FDA ON : 10/08/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21 CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN CO PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED = 1.
REPORT STATES PT RECEIVED A BREAST IMPLANT ON 7/23/91. PT ALLEGES SHE EXPERIENCED THE FOLLOWING PROBLEMS: TWISTING INTERNALLY, 1994; PROTRUDING OUT OF CORNERS OF BREAST WALL, 5/94, 8/95 AND SEPTEMBER ON 10/2/95. PHYSICIAN DESCRIBES ALLEGATIONS AS FOLLOWS: REPEATED CAPSULAR CONTRACTURE OF LEFT RECONSTRUCTED BREAST AND ONE EXTRUSION OF THE IMPLANT. REFERENCE 11147091A.
ADDITIONAL INFORMATION RECEIVED ON 12/3/96 INDICATES THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED DUE TO FLUID LOSS--CONNECTOR FAILURE.
SUMMARY OF EVALUATION: THE TIBIAL INSERT AND PATELLAR COMPONENT CAN NOT BE EVALUATED FOR THE REPORTED WEAR AND PEG SHEARING OF THE PATELLAR PEGS AS THEY HAVE NOT BEEN RETURNED TO HOWMEDICA, BUT RATHER HAVE BEEN RETAINED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE LOT CODE OF THE PATELLAR COMPONENT HAS NOT BEEN SUPPLIED SO THAT A REVIEW OF ITS DEVICE HISTORY RECORD IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THIS LOT CODE INFO AND THE DEVICE HAVE BEEN UNSUCCESSFUL.
IT WAS REPORTED DIFFICULT DEFLATION WAS ENCOUNTERED FOLLOWING THE COMPLETION A SUCCESSFUL ILIAC ANGIOPLASTY. ATTEMPTS TO FULLY DEFLATE THE BALLOON WERE UNSUCCESSFUL. DURING WITHDRAWAL OF THE PARTIALLY DEFLATED BALLOON, THE BALLOON MATERIAL BEGAN TO DETACH FROM THE CATHETER SHAFT. THE CATHETER WAS LEFT IN PLACE AND THE PT UNDERWENT SURGICAL REMOVAL OF THE BALLOON CATHETER. NO PT SEQUELAE RESULTED FORM THIS EVENT AND THE PT'S CONDITION IS GOOD. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION REVEALED A CIRCUMFERENTIAL TEAR IN THE BALLOON MATERIAL 7.2CM FROM THE DISTAL TIP. THE PROXIMAL RO MARKER HAD BEEN REMOVED AND WAS LOCATED 3MM PROXIMAL TO THE DISTAL RO MARKER. THE BALLOON MATERIAL WAS BUNCHED UP AT THE DISTAL END OF THE CATHETER SHAFT. THE SHAFT UNDER THE BALLOON APPEARED TO BE SLIGHTLY ELONGATED. THE BALLOON MATERIAL WAS VERY WRINKLED, HOWEVER, NO BALLOON MATERIAL APPEARED TO BE MISSING. ALTHOUGH THE ACCOUNT INDICATED CONTINUAL EXERTION WAS NOT APPLIED TO THE BALLOON CATHETER, THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH EXCESSIVE FORCE, AN ELONGATED SHAFT. CO BELIEVES, THIS FACTOR MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, BASED ON CO FOLLOW UP, CO UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTION FOR USE STATE: "IF RESISTANCE IS CONCOUNTERED DUE TO BALLOON RUPTURE OR FOR ANY OTHER REASON WHEN REMOVING EITHER A CATHETER THROUGH AN INTRODUCER SHEATH OR A GUIDEWIRE THROUGH A CATHETER, STOP AND REMOVE THEM AS A COMPLETE UNIT TO PREVENT DAMAGE TO THE GUIDEWIRE, CATHETER, INTRODUCER SHEATH, OR VESSEL."
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO "MALFUNCTION". ADD'L INFO REC'D ON 9/24/96 INDICATES CHRONIC PAIN. ADD'L SERIAL #: 8095M 007. ADD'L LOT #: 7160M 016.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. TUBING WAS FUNCTIONAL.
THE BABY CRASHED ONE-DAY POST OPERATIVELY (HYPOPLASTIC LEFT HEART SYNDROME) AND WAS PLACED ON DEVICE. THE PERFUSIONIST WAS CALLED IN BY THE NURSING STAFF MONITORING THE DEVICE BECAUSE THE PRE AND POST MEMBRANE PRESSURE DIFFERENCE HAD INCREASED TO APPROX 300 MMHG. THE PRESSURE TRANSDUCER LINES FLUSHED WITHOUT PROBLEM. BY THE TIME THE PERFUSIONIST ARRIVED, THE DEFFERENCE WAS 500 MMHG AND THE PO2 WAS DECREASING AND PCO2 WAS INCREASING. ACT'S WERE BETWEEN 180 AND 220 SECONDS PER PROTOCOL WITH A CONSTANT DRIP. THE PERFUSIONIST INSPECTED THE OXYGENATOR AND DID NOT SEE ANY SHIFTING OF THE MEMBRANE. THE BABY DID NOT IMPROVE WITH DEVICE SUPPORT AND EXPIRED.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IF NOT, THEN IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? UNKNOWN/NO DATA. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? UNKNOWN/NO DATE. THIS REPORT IS PROVIDED PURSUANT TO 21 CFR 803, AND DOES NOT CONSTITUTE AN ADMISSION OR ACKNOWLEDGMENT THAT THE DEVICE REFERENCED ABOVE CONTAINS A DEFECT, MALFUNCTION, OR WAS IN ANY WAS CONNECTED WITH OR CONTRIBUTED TO ANY INJURY OR DEATH. 510(K) K863476.
CENTER REPORTED THAT 1.5 HOURS INTO THE HEMODIALYSIS TREATMENT THE VENOUS PRESSURE ALARM SOUNDED. A STAFF MEMBER WENT TO CHECK THE PT AND FOUND HER UNRESPONSIVE WITH NO DETECTABLE BLOOD PRESSURE. BLOOD WAS ALSO SEEN ON THE FLOOR. ESTIMATED BLOOD LOSS WAS NOT DETERMINED. ON CLOSER EXAMINATION, THE VENOUS NEEDLE HAD BEEN ACCIDENTALLY PULLED OUT BY THE PT DURING TREATMENT. CPR WAS STARTED BY STAFF AND EMERGENCY HELP WAS CALLED. THE PT WAS TRANSPORTED TO THE EMERGENCY ROOM WHERE SHE WAS PRONOUNCED DEAD. THE CAUSE OF DEATH WAS REPORTED AS:CARIOPULMONARY ARREST.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 1/25/91. PT ALSO ALLEGES TENDERNESS AND BURNING SENSATION ON 9/22/92, PAIN AND HARDNESS ON 2/1/93, AND PAIN AND SWELLING ON 5/7/96, AND 7/2/96. SHE ALSO ALLEGES MANIPULATION BY A PHYSICIAN CAPSULATION ON 2/1/93. PHYSICIAN ALLEGES CONSTANT AND INCREASED PAIN, DISCOMFORT-DAY AND NIGHT, BREAST CAPSULE FORMATION, CT SCAN 6/25/96 SAYS INTERNAL RUPTURE BOTH SIDES.
GUIDEWIRE BECAME STUCK AND HAD TO BE SURGICALLY REMOVED.
D-6 CAT #507-714Y. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE GUIDEWIRE WAS FOUND TO BE FRACTURED AT THE TIP, WITH THE DISTAL GUIDEWIRE SEGMENT WITHIN A SEPARATE PLASTIC BAG. THE DISTAL TIP COILS WERE FOUND TO CONTAIN A CLUMP OF WHAT APPEARED TO BE BLOOD AND POSSIBLY TISSUE ATTACHED TO THE COILS . A PROXIMAL RIBBON FRACTURE SITE ALONG WITH A BEND IN THE COREWIRE, 6 MM PROXIMAL TO THE FRACTURE SITE WERE NOTED. THE COILWIRE WAS FOUND TO BE SEPARATED (SUBSEQUENTLY DETERMINED TO BE CUT) AND STRETCHED ADJACENT TO BOTH FRACTURED ENDS. THE LENTH OF THIS GUKDEWIRE, MINUS THE SEPARATED DISTAL SEGMENT WAS 299.4 CM. MICROSCOPIC EXAMINATION: FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) ON BOTH FRACTURED RIBBON ENDS, INCLUDING THE SEPARATED COILWIRE ENDS WAS PERFORMED. THE FRACTURED SURFACES EXHIBITED GOOD MATERIAL DUCTILITY AND THE FRACTURE IS BELIEVED TO HAVE BEEN CAUSED BY TORSIONAL OVERLOADING TO FAILURE. THE COILWIRE WAS FOUND TO HAVE BEEN CUT BY AN INSTRUMENT DUE  TO THE FLAT AND STRIATENED SURFACE OBSERVED. THIS IS THE FIRST TWISTED RIBBON FRACTURE IN THIS FAMILY OF GUIDEWIRE.
CONSUMER HAD AN UNAPPROVED PEDICLE SCREW IMPLANTED APPROX 2 YEARS AGO. HE BECAME DISABLED BY THE IMPLANT. HE DID SIGN AN INFORMED CONSENT AND WAS AWARE THAT THE PRODUCT WAS NOT APPROVED AT THE TIME OF IMPLANT; ALTHOUGH,  THE DR SAID THE PRODUCT WOULD BE APPROVED IN A FEW MONTHS. THE CONSUMER WAS RELUCTANT TO PROVIDE MORE SPECIFIC INFO AT THE TIME OF HIS PHONE CALL.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED. NO REASON FOR THE SURGERY WAS PROVIDED.
PT OPENED THE PACKAGE AND THE DIAPER WAS CONTAMINATED WITH YELLOW COLOR, LIKE URINE, AND RED COLOR, LIKE BLOOD. THE DIAPER WAS DRIED BUT PT DID NOT USE IT. PT USED THE OTHER DIAPERS FROM THE SAME PACKAGE AND SHE WAS CONCERNED OF GETTING AN INFECTION.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA.
SUMMARY OF EVAL: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS THEY HAVE NOT BEEN RETURNED TO CO. THE LOT CODES HAVE NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 12/5/84. SHE ALSO ALLEGES, "IMPLANTS GONE SOFT BETWEEN 1993 TO 1996, IMPAIRED IMMUNITY SYSTEM, I.E. COLDS, FLU, FLU, WEIGHT LOSS, CONSTANT ILLNESS BETWEEN 1993 AND 1996 AND SWOLLEN BREASTS, 1996." PHYSICIAN ALLEGES, "RIGHT BREAST BECAME SWOLLEN AND PAINFUL; EXPLORED 3/25/96-PROSTHESES RUPTURED ON BOTH SIDES -GEL ON RIGHT HAD LIQUIFID AND GUSHED FROM BREAST.' SHE HAD BILATERAL REMOVAL ON 3/25/96 AND REPLACEMENT WITH DEVICES OF ANOTHER MFR.
CONCLUSION: 68A OTHER (NO DEVICE RETURNED).
REPORT RECEIVED FROM THE FIELD INDICATED THAT THIS VALVE WAS IMPLANTED IN A PT WITH A DIAGNOSIS OF IDIOPATHIC HYDROCEPHALUS. SEVEN MONTHS POST IMPLANT THE VALVE APPEARED TO BE OVER DRAINING AND WAS EXPLANTED AND REPLACED UNEVENTFULLY WITH A NEW VALVE. THERE WAS NO REPORT OF INJURY OR COMPLICATIONS. ANALYSIS OF THE RETURNED VALVE REVEALED THE PRESENCE OF DEBRIS/RESIDUE ADHERING TO THE VALVE MECHANISM, THUS IMPAIRING THE VALVE'S ABILITY TO FUNCTION PROPERLY. THIS CONDITION IS A KNOWN COMPLICATION OF VALVE THERAPY FOR HYDROCEPHALUS AND IS INDICATED IN THE INSTRUCTIONS FOR USE.
ON 2/23/83, AN AUS DEVICE WAS IMPLANTED. ON 4/25/83, THE CONTROL ASSEMBLY IMPLANTED. ON 9/3/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE-CUFF ATROPHY.
BALLOON PRESSURE NOT WITHIN SPECS. CUFF HAD A WEAR LEAK. PUMP PERFORMED WITHIN SPECS.
THE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS-CUFF TUBING AT PUMP AND REPLACED.
PUMP/TUBING JUNCTION HAD FATIGUE AND WEAR LEAK. CUFF PERFORMED WITHIN SPECS. BALLOON PRESSURE NOT WITHIN SPECS.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 10/3/85. PT ALSO ALLEGES SYMPTOMS, "MISSHAPEN AND TOO HIGH " AS OF 7/95 AND 7/96. PHYSICIAN ALLEGES "HARDNESS AND DISPLACEMENT."
COMPLAINANT ALLEGED THAT STAFF MEMBERS WERE TRANSPORTING A FEMALE PATIENT (AGE UNK) TO HAVE CAT SCAN PERFORMED. THE PT WENT INTO CARIAC ARREST AND REQUIRED DEFIBRILLATION. THE STAFF ATTEMPTED TO CHARGE THE UNIT TO 200J, BUT THE UNIT ONLY CHARGED TO 180J. THE UNIT DID NOT DISCHARGE. IT IS UNK IF THE UNIT PRINTED A STRIP. THE STAFF OBTAINED ANOTHER UNIT AND DEFIBRILLATED THE PATIENT. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.THE PT WAS TRANSFERRED TO ANOTHER FACILITY AND LATER EXPIRED. THE COMPLAINANT INDICATED THAT THE PT EXPIRED AS A RESULT OF "ADDITIONAL INJURIES" OBTAINED AT THE SECOND  FACILITY. THE COMPLAINANT ALSO INDICATED THAT AT THE TIME OF THE ALLEGED MALFUNCTION, A POWERCHARGER WAS ATTACHED TO THE UNIT, BUT IT WAS NOT PLUGGED IN.
THIS EVENT WAS REPORTED AS: DEHISCENCE. NO FURTHER INFO PROVIDED.
THE DEVICE WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE AND REPLACED.
PT ALLEGES RECEIVING IMPLANTS ON 9/20/89. PT ALSO ALLEGES EXPERIENCING PROBLEMS BEGINNING IN 1/91, INCLUDING PAIN, SWELLING, DISCOMFORT, ABNORMAL AUGMENTED SHAPE, SENSITIVITY AND HARDNESS. PHYSICIAN'S NOTE STATES: "HARD CAPSULE FORMATION (ESPECIALLY ON RIGHT SIDE), ABNORMAL IMPLANT AUGMENTED BREAST SHAPE, RIGHT-SIDED PAIN IN BREAST WHEN FLEXING PECTORALIS MUSCLE OR WHEN BREAST IS PRESSED."
PT UNDERWENT A LAPAROSCOPIC APPENDECTOMY. WHEN THE TROCAR WAS INSERTED, BOTH ILIAC ARTERIES WERE LACERATED. IT IS SUSPECTED THAT THE SAFETY SHIELD DID NOT DEPLOY PROPERLY. THE PROCEDURE WAS CONVERTED TO OPEN, AND THE PT REQUIRED TRANSFER TO ANOTHER FACILITY AND REQUIRED ANOTHER SURGICAL PROCEDURE TO CORRECT VASCULAR DEFECTS.
THE LEAD WAS EXPLANTED DUE TO REPORT OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
DURING PROCEDURE, BLUE TIP OF GUIDEWIRE CAME OFF. THE PIECE COULD NOT BE LOCATED AFTER THE PROCEDURE. X-RAY WAS PERFORMED TO LOCATE BLUE TIP; HOWEVER, IT WAS NOT RADIOPAQUE.
ON 8/22/85 AN AUS DEVICE WAS IMPLANTED. ON 5/16/85 THE PUMP AND BALLOON WERE REVISED AND THE CUFF WAS REMOVED. ON 10/24/95, THE CUFF WAS REIMPLANTED. ON 9/6/96 THE CUFF WAS REMOVED FORM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
FACILITY ALLEGES A BLOOD LEAK OCCURRED ON A DIALYZER ONE HR AND FIVE MINUTES INTO TREATMENT. THE BLOOD LEAK WAS DETECTED BY A BLOOD LEAK ALARM, NO VISUAL BLOOD IN THE DIALYSATE. DIALYSIS WAS DISCONTINUED AND BLOOD RETURNED TO THE PT; THEREFORE NO BLOOD LOSS OCCURRED. BLOOD PRESSURE STABLE. THE DIALYSIS TREATMENT WAS RESUMED WITH ANOTHER DIALYZER AND COMPLETED WITH NO ADVERSE SYMPTOMS NOTED PRIOR TO THE PT LEAVING THE DIALYSIS UNIT ON 9/18/96. THE NEXT MORNING (9/19/96), THE PT COMPLAINED OF DIZZINESS, INSOMNIA, NIGHTMARES, NAUSEA, VOMITING AND WHEEZING. THE PT'S EYES WERE RED AND SHE COMPLAINED OF VISION PROBLEMS. THE FACILITY REPORTED THAT THE DIALYZER INVOLVED IN THE BLOOD LEAK INCIDENT HAD BEEN DISCARDED AND THERE ARE NO DIALYZERS FROM THE SAME LOT NUMBER AVAILABLE.
THE DIALYZER ALLEGEDLY INVOLVED IN THIS INCIDENT WAS A CO'S DIALYZER MFG IN 4/85. IT HAS BEEN REPORTED THAT AT THE TIME OF THIS DIALYSIS TREATMENT, A CART WAS BEING SPRAY PAINTED INSIDE THE DIALYSIS UNIT. ADD'L INFO WILL BE PROVIDED WHEN AVAILABLE.
UPON DIALING THE INTRAOCULAR LENS INTO THE CAPSULAR BAG, THE LENS HAPTIC WENT THROUGH THE BAG. A VITRECTOMY WAS PERFORMED.
H6: CODE 100=BENT HAPTICS.EVALUATION RESULTS: BOTH OF THE HAPTICS ARE BENT. BOTH SURFACES OF THE OPTIC HAVE SCRATCHES AND ABRASIONS.
THE AUS DEVICE WAS RMEOVED FROM THE PT AND REPLACED DUE TO INFECTION.
PT WENT TO OR FOR A RIGHT TOTAL HIP REPLACEMENT. WHILE THE SURGEON WAS DRILLING WITH A DRILL BIT THE TIP OF THE BIT BROKE OFF REMAINING IN THE PT. PT IS AWARE AND AGREED TO LEAVE INSIDE INSTEAD OF FURTHER EXPLORING.
ATTORNEY ALLEGES "SON OF CLIENT DIED AS A RESULT OF CARDIAC ARREST AND ACUTE PULMONARY EDEMA." FOUR YEARS PRIOR TO DEATH A PACEMAKER WAS IMPLANTED." "...DESPITE INTENDED PURPOSE OF PACEMAKER, AS A RESULT OF DEFECTS AND/OR DESIGN FLAWS, THE PACEMAKER FAILED TO FUNCTION PROPERLY AND PT DIED."
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATIONS DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATIONS OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. EVAL CONCLUSION: NO CONCLUSION CAN BE DRAWN. REFERENCE 1647346-1996-0004. EVENT INCLUDED IN LABELING. INTERNAL NUMBER IS 650748.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE DEACTIVATION BUTTON WAS STUCK.
ON 7/16/96 DURING THE ADMINISTRATION OF FLUIDS, THE PT COMPLAINED OF PAIN. SWELLING IN THE CHEST WAS NOTED. AN X-RAY WAS TAKEN WHICH SHOWED THE CATHETER HAD FRAGMENTED. THE CATHETER FRAGMENT WAS REMOVED FROM THE PT VIA A CARDIAC CATHETER.
PT COMPLAINS OF PAIN AND DISCOMFORT IN BOTH BREASTS, MORE SO ON RIGHT SIDE. PAIN RADIATING TO RIGHT SHOULDER AND RIGHT UPPER BACK. PT COMPLAINS OF A "PULLING" SENSATION AND SHARP PAIN IN HER BREASTS FROM TIME TO TIME. RIGHT AND LEFT IMPLANT LEAKING.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO CUFF MALPOSITIONED.
PUMP PERFORMED WITHIN SPECS. BALLOON PERFOMRED WITHIN SPECS. CUFF PERFORMED WITHIN SPECS.
LENS REPLACEMENT ONE DAY POSTOPERATIVE BECAUSE OF A BROKEN LENS.
A4:ACCOUNT UNABLE TO PROVIDE INFORMATIONH6:CODE 100=BROKEN HAPTIC.EVALUATION RESULTS: ONE OF THE HAPTICS IS BROKEN AT THE HAPTIC/OPTIC JUNCTION. THE DIMENSIONAL MEASURMENTS OF THE HAPTIC AT THE BREAKAGE LOCATION MEET DESIGN SPECIFICATIONS.
THE CATHETER WAS PLACED 1/19/96 FOR TREATMENT OF A NECK INFECTION. IT WAS REPORTED THAT THE CATHETER "BROKE". NO OTHER INFO IS AVAILABLE.
A LOT HISTORY REVIEW OF LOT 36EF7453 FOUND NO RELATED MFG ISSUES AND ONE OTHER PRODUCT COMPLAINT OF SIMILAR NATURE WHICH WAS DETERMINED TO BE USER-RELATED. AN EVALUATION OF THE DEVICE IS NOT POSSIBLE, AS IT HAS NOT BEEN RETURNED TO THE MFR.
FALSE SENSING AND FAILURE TO SENSE AND CAPTURE. WIRE BROKE.
THE EXPERIENCES DESCRIBED IN THE EVENT CODES ARE INCLUDED IN THE LABELING. FIRM CONTROL # 650896.
INFORMATION RECEIVED ON 11/8/96 INDICATES REASON AS EROSION AT BULBOUS URETHRA.
ON 8/27/93, AN AUS DEVICE WAS IMPLANTED. ON 3/23/94, THE CUFF WAS REVISED. ON 6/14/96, THE CUFF WAS REMOVED FROM THE PT. ON 9/12/96 THE PUMP WAS REMOVED FROM THE PT DUE TO EROSION.
ALLEGED AUTOIMMUNE DISEASE, SILICONE MIGRATION, VARIED INJURIES. FOLLOW-UP FINDINGS: REPORT NOT SUBSTANTIATED BY A HEALTH PROFESSIONAL. OUTCOME: UNDETERMINED.
UNSUBSTANTIATED CONNECTIVE TISSUE AUTOIMMUNE DISORDERS.UNSUBSTANTIATED SILCONE MIGRATION OR EXTRAVASATION.UNSUBSTANTIATED VARIED INJURIES.THE POTENTIAL FOR THE ABOVE-NOTED EVENT TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING.AS PER 21 CFR, PART 803.16, THIS REPORT AND INFORMATION DOES NOT NECESSARILY REFLECT CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.MCGHAN MEDICAL DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF MMC'S EVALUATION OF THE DEVICE.MCGHAN MEDICAL'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE DOUBTS IN FAVOR OF REPORTING. FILING A MDR DOES NOT CONSTITUTE AN ADMISSION BY MMC THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CASUAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. REPORTS ARE BASED ON INFORMATION SUPPLIED TO MCGHAN MEDICAL AND THE SUBSEQUENT INVESTIGATION. CO CONSIDERS THIS INFORMATION TO BE HIGHLY CONFIDENTIAL AND, THEREFORE, REQUESTS ITS PROTECTION FROM ANY REQUEST, PURSUANT TO 21 CFR PART 803.9 (B).
ON 5/17/91, AN AUS DEVICE WAS IMPLANTED. ON 7/14/95 THE CUFF WAS REMOVED. ON 10/10/95 THE CUFF WAS REIMPLANTED. ON 9/3/96 THE CUFF WAS REMOVED FORM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
THE CONNECTOR WAS REMOVED FROM THE PT AND REPLACED DUE RECURRING INCONTINENCE-TUBING KINKED.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-TEAR IN TUBING TO CYLINDER SIDE RIGHT ANGLE CONNECTOR.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. TUBING HAD A FATIGUE AND WEAR LEAK.
INFO RECEIVED ON 9/11/96, INDICATES THE DEVICE WAS REMOVED FROM THE PT ON 4/1/95, NO REASON FOR THE SURGERY WAS PROVIDED.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO TRAUMA.
THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED, REASON AND DETAILS NOT AVAILABLE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-LEAK POINTS IN LEFT CYLINDER. ADD'L LOT AND SERIAL NUMBERS: 6287P 005.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER HAS OR DAMAGE. CYLINDER HAD A FATIGUE LEAK. TUBING WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION-WANTED AN INFLATABLE.
THE RIGHT ROD WAS REMOVED FROM THE PT DUE TO INFECTION.
A PT PRESENTED WITH LOOSE IMPLANT, GRANULATION TISSUE, RESTORED WITH FULL UPPER DENTURE. DR ELECTED TO REMOVE IMPLANT.
DENTAL ASSISTANT REPORTED IMPLANT FAILURE ASSOCIATED WITH PERIO INFLAMMATION AND BONE LOSS. PT SAME AS PRIOR MDR REPORT #M764677.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGNS REQUIREMENTS. A REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS COMPLETED AND FOUND TO BE ACCEPTABLE POER RELEASE CRITERIA.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MD REPORTS M406462 AND N455544.
DURING INSPECTION IT WAS NOTED THAT THE PART NUMBER IS 0635, NOT 0634 AS ORIGINALLY REPORTED. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR.
DURING CATHETER PLACEMENT, CATHETER WRINKLED WHEN GUIDEWIRE WAS REMOVED. THEN CATHETER LEAKED WHEN FLUSHED. DURING ATTEMPT TO REMOVE CATHETER, RESISTANCE WAS MET. THE PT WAS TAKEN TO THE HSP WHERE THE SURGEON MADE AN INCISION TO REMOVE THE CATHETER FROM THE PT'S ARM. IT WAS REPORTED THAT THE CATHETER HAD A KNOT IN IT.
THE PT IS RETAINING HE PRODUCT AT THIS TIME.
PT BEGAN HAVING PAIN IN LEFT ANTERIOR SHOULDER AREA FOLLOWING LAST CHEMO TREATMENT. MD SENT PT FOR X-RAY, DISCOVERED LEAK, AND ARRANGED FOR SURGICAL CONSULT. PT WAS TAKEN TO OR AND TUBING OF PORTA-CATH WAS CHANGED.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED TO INTEGRATE. PT IS REPORTEDLY FINE.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORTS #M491140 AND M522463.
PRIMING BEING DONE FOR CABG. FIBER LEAK NOTICED AND UNIT REPLACED. OXYGENATOR STARTED FOAMING AND FLUID COLLECTED IN CANISTER. FIBERS APPEARED "WET." PT REMAINED STABLE. UNIT REMOVED.
THE CATHETER HAD BEEN IN PLACE APPROXIMATELY 2-3 MONTHS WHEN THE INCIDENT OCCURRED. THE PT WAS RECEIVING NACL PLUS KCL WHEN THE FIRST LEAK WAS NOTED. AN X-RAY AND DYE STUDY WERE DONE WHICH SHOWED NO PROBLEMS. DURING SECOND COURSE OF CHEMOTHERAPY ON 9/6/96, EXTRAVASATION OCCURRED INSTANTANEOUSLY AT THE SKIN TUNNEL EXIT SITE. THE PT EXPERIENCED BLISTERING.
THE RED LUMEN WAS EASILY FLUSHED AND ASPIRATED WITHOUT DIFFICULTY. THE WHITE LUMEN WAS DIFFICULT TO FLUSH AND COULD NOT BE ASPIRATED DUE TO CRYSTALLIZED MEDICATION IN THE LUMEN. A LEAK WAS NOTED APPROX .35" PROXIMAL TO THE DACRON CUFF AND WAS PRESENTED AS A SMALL, IRREGULAR LINE TRAVELING LONGITUDINALLY ALONG THE CATHETER. THE LEAK SITE APPEARED TO HAVE BEEN CAUSED BY A PUNCTURE FROM A HYPODERMIC OR SUTURE NEEDLE.
DEVICE WAS REMOVED FORM THE PT DUE TO FLUID LOSS AT RIGHT CYLINDER-FLUID BATWEEN LAYERS-AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A FATIGUE LEAK. CONNECTOR WAS FUNCTIONAL.
DURING A DIALYSIS TREATMENT, THE HEPARIN/SALINE LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A RETURN GOODS AUTHORIZATION WAS ISSUED FOR THE AFFECTED ASSEMBLY ON 9/16/96. HOWEVER, AS OF 10/7/96, NO CLAMPS WERE RETURNED FOR INVESTIGATION. THE FACILITY HAS NOT RETURN THE DEFECTIVE CLAMPS BECAUSE THEY HAVE NOT REPLACED THE CLAMP ASSEMBLIES ON THE MACHINES. ON 10/7/96, QUALITY ASSURANCE CONTACTED THE FACILITY AND STRONGLY ENCOURAGED THEM TO RETURN PARTS FOR INVESTIGATION. THE FACILITY PROMISED TO SEND PARTS BACK IMMEDIATELY. AS OF 10/16/96, NO PARTS WERE RETURNED. HISTORICAL ANALYSIS OF NUMEROUS IDENTICAL COMPLAINTS (SEE FOR EXAMPLE: 0896037C3, 0796207C3, 0796157C3, 0796160C3, AND 0796180C3) INDICATE THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED ON THESE EARLIER COMPLAINTS THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IT APPEARS THAT THESE PROBLEMS OCCUR WITH NORMAL USE AND HANDLING OF THE CLAMP, AND NOT BECAUSE OF USER MISUSE, WHICH WAS ORIGINALLY CONSIDERED TO BE THE CAUSE. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE CS3 OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PATIENT CAN RESULT. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE BROKEN LINE CLAMP DESCRIBED IN THIS COMPLAINT WAS GENERATED BECAUSE OF WEAK TAB STOPS AND/OR CAM INSERT HOLDERS ON THE CLAMP. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027.
S/P LT MASTECTOMY WITH 2ND STAGE BREAST RECONSTRUCTION. RT S/P RADIATION RX, S/P CHEMOTHERAPY, S/P BONE MARROW TRANSPLANT.
DR REPORTS EXTRUSION OF IOL. ORIGINAL IMPLANT WAS PERFORMED BY ANOTHER SURGEON, DATE UNKNOWN, AND VITREOUS LOSS WAS EXPERIENCED SO AN ANTERIOR CHAMBER IOL WAS PLACED. A VITRECTOMY TO THE WOUND WAS PERFORMED AND THE IRIS BECAME CAUGHT IN THE VITRECTOMY. DR SPECULATED THAT, DUE TO CONTRACTION OF THE VITRECTOMY AND PROGRESIVE SYNECHIAE, PRESSURE WAS TRANSFERRED TO THE HAPTIC. THIS RESULTED IN THE HAPTIC ERODING THROUGH THE SCLERA AND CONJUNCTIVA WITH EVENTFUL EXPOSURE TO THE OUTSIDE OF THE EYE, NECESSITATING REMOVAL.
EVALUATION OF EXPLANTED LENS REVEALED THE LENS WAS COATED WITH BLOOD AND CLINICAL SOLUTION. NO DEFECTS WERE NOTED. THE MFR'S INTERNAL REFERENCE NUMBER IS 96L4990. THIS REPORT WAS MAILED IN TO FDA ON: 10/9/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. NUMBER OF PERSONS AFFECTED=1.
ON 2/21/95 DEVICE WAS IMPLANTED. ON 9/12/96 THE PUMP WAS REMOVED. ON 2/27/96 THE PUMP WAS REIMPLANTED. ON 9/10/96 THE PUMP WAS REMOVED FROM THE PT BECAUSE IT HAD ERODED THROUGH THE SKIN.
THE TIP OF CATHETER BROKE THROUGH THE WALL OF THE BLADDER.
ACTUAL DEVICE WAS EVALUTATED AND MET ALL MFR AND FUNCTIONAL REQUIREMENTS. THE MD REPRTED THAT THE PT, A 76 YEAR OLD FEMALE, HAD A PREDISPOSING CONDITION (A WEAKENED AND SMALL 5-6 CM BLADDER) THAT HE FELT CONTRIBUTED TO THE ACTUAL EVENT. NO PRODUCT PROBLEM WAS IDENTIFIED. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFROMATION NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FRUTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSTION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED FOR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF OF ITS PRODUCTSF HAS MALFUNCTIONED
THE PORT WAS PLACED 7/18/96. IT WAS REPORTED THAT THERE WAS NO BLOOD RETURN FROM THE PORT. A "PORT-A-CATHOGRAM" WAS DONE AND SHOWED THAT THE CATHETER HAD SEPARATED FROM THE PORT. THE CATHETER WAS REMOVED FROM THE PT WITH OUT INJURY.
A RETURN GOODS AUTHORIZATION WAS ISSUED FOR THE AFFECTED ASSEMBLY ON 9/16/96. HOWEVER, AS OF 10/7/96, NO CLAMPS WERE RETURNED FOR INVESTIGATION. THE FACILITY HAS NOT RETURN THE DEFECTIVE CLAMPS BECAUSE THEY HAVE NOT REPLACED THE CLAMP ASSEMBLIES ON THE MACHINES. ON 10/7/96, QUALITY ASSURANCE CONTACTED THE FACILITY AND STRONGLY ENCOURAGED THEM TO RETURN PARTS FOR INVESTIGATION. THE FACILITY PROMISED TO SEND PARTS BACK IMMEDIATELY, AS OF 10/16/96, NO PARTS WERE RETURNED. HISTORICAL ANALYSIS OF NUMEROUS IDENTICAL COMPLAINT (SEE FOR EXAMPLE: 0896037C3, 0796207C3, 0796157C3, 0796160C3, AND 0796180C3) INDICATE THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED ON THESE EARLIER COMPLAINTS THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IT APPEARS THAT THESE PROBLEMS OCCUR WITH NOMRAL USE AND HANDLING OF THE CLAMP, AND NOT BECAUSE OF USER MISUSE, WHICH WAS ORIGINALLY CONSIDERED TO BE THE CAUSE. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE CS3 OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PATIENT CAN RESULT. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE BROKEN LINE CLAMP DESCRIBED IN THIS COMPLAINT WAS GENERATED BECAUSE OF WEAK TAB STOPS AND/OR CAM INSERT HOLDERS ON THE CLAMP. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027.
PTCA PT. SENT "STUCK" IN L MAIN. COULD NOT RETRIEVE. PT TO OR FOR URGENT CABG (WOULD HAVE REQUIRED SURGERY DUE TO HIGH GRADE STENOSIS OF THE LARGE PROXIMAL CIRCUMFLEX VESSEL) AND THREE VESSEL CAB STENT REMAINS IN PT.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO RUPTURE OF RIGHT CYLINDER -OUTER SHEATH RUPTURED AND DACRON ADHERED TO THE TISSUE.
THERE WAS NO BLOOD RETURN FROM A PORT AND A PORT A CATHOGRAM WAS DONE. THIS FILM SHOWED THAT THE CATHETER WAS SEPARATED FROM THE PORT. THE RETAINED PORTION WAS RETRIEVED WITHOUT INJURY.
THE PRODUCT HAS NOT YET BEEN RETURNED TO THE MFR.
IV ACCESS DEVICE "ACCIDENTLY" PULLED OUT. REPORTED BY PT. NURSE CHECKING DEVICE NOTED DEVICE NOT INTACT. CATHETER PIECE MISSING BEYOND HUB.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AT THE RESERVOIR AND REPLACED. ADD'L LOT/SER #: 7900K 014.YDIY9/5/96
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD OR DAMAGE. TUBING WAS FUNCTIONAL.
A MEDICAL SERVICES EMPLOYEE RECEIVED A NEEDLE STICK IN THE STOMACH WHEN A NEEDLE ALLEGEDLY PROTRUDED THROUGH THE BOTTOM OF THE SHARPS CONTAINER. THE EMPLOYEE RECEIVED A TETANUS SHOT.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FOOD AND DRUG ADMINISTRATION BY SIMS, INC. PURSUANT TO 21 C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AN ADMISSION BY THE COMPANY THAT A SIMS DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE AND A REPORTD DEATH OR SERIOUS INJURY. D9-AVAILABLE FOR THIRD PARY TESTING. D5,D6,H4-UNK BECAUSE LOT # WAS LOCATED ON THE DISCARDED OVERPAK. H6(RESULTS) CODE 100- TESTING OF SIMILAR PRODUCT DID NOT REVEAL A PRODUCT MALFUNCTION. H6(CONCLUSION) CODE 68-CAUSE OF EVENT UNKNOWN; TESTING SIMILAR PRODUCT DID NOT REVEAL A PRODUCT MALFUNCTION.
DURING INSERTION OF APEX HOLE ELIMINATOR INTO ACETABULAR SHELL, SCREWDRIVER TIP BROKE OFF AND WAS STUCK IN ELIMINATOR. DIAMOND BURR WAS USED TO SMOOTH THE END OFF AS IT COULD NOT BE EXTRACTED. MASSIVE IRRIGATION DURING BURR PROCESS.
SUMMARY OF EVALUATION: THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO MECHANICAL OVERSTRESS OF THE SCREWDRIVER TIP DUE TO MISAPPLICATION AND MISUSE OF THE DEVICE. THE SALES REPRESENTATIVE TO INSTRUCT THE USERS ON THE PROPER USE AND APPLICATION OF THE INSTRUMENT.
RATE OF INFUSION ON PUMP CHANGED ON ITS OWN X 2. ON INFUSION #1 AN INSULIN DRIP SET AT 2ML/HR INFUSED 200CC'S IN LESS THAN AN HR. WITHIN 30 MIN OF THIS EVENT THE DOPAMINE DRIP ON THE SAME PUMP BUT A DIFFERENT CHANNEL WENT FROM 20MCG/KG/MIN TO 2 MCG/KG/MIN.
OXYGENATOR FIBER LEAK NOTED BEFORE CASE STARTED IN OR.
THE TABS ON THE CLAMP KEYS WORN AND/OR BROKE OFF AND THE KEYS NO LONGER STOP IN THE CLOSED POSITION. A REVIEW OF THE CPF/DTF HISTORY WAS NOT POSSIBLE DUE TO AN UNKNOWN SERIAL NUMBER. A RETURN GOOD AUTHORIZATION WAS ISSUED FOR THE AFFECTED ASSEMBLY ON 09/16/96. HOWEVER, AS OF 10/07/96, NO CLAMPS WERE RETURNED FOR INVESTIGATION. THE FACILITY HAS NOT RETURN THE DEFECTIVE CLAMPS BECAUSE THEY HAVE NOT REPLACED THE CLAMP ASSEMBLIES ON THE MACHINES. ON 10/7/96, QUALITY ASSURANCE CONTACTED THE FACILITY AND STRONGLY ENCOURAGED THEM TO RETURN PARTS FOR INVESTIGATION. THE FACILITY PROMISED TO SEND PARTS BACK IMMEDIATELY. AS OF 10/16/96, NO PARTS WERE RETURNED. HISTORICAL ANALYSES OF NUMEROUS IDENTICAL COMPLAINTS INDICATE THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED ON THESE EARLIER COMPLAINTS THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IT APPEARS THAT THESE PROBLEMS OCCUR WITH NORMAL USE AND HANDLING OF THE CLAMP, AND NOT BECAUSE OF USER MISUSE, WHICH WAS ORIGINALLY CONSIDERED TO BE THE CAUSE. THE ABOVE INFO INDICATES THAT THE BROKEN LINE CLAMP DESCRIBED IN THIS COMPLAINT WAS GENERATED BECAUSE OF WEAK TAB STOPS AND/OR CAM INSERT HOLDERS ON THE CLAMP. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED:Y. SALES/SERVICE CONTACTED BY INVESTIGATOR:N. TRAINING REQUIRED:N.
PER THE INFO PROVIDED TO CO BY HOSPITAL, THE DEVICE WAS REMOVED APPROX. ON 8/96, HOWEVER NO SPECIFIC DAY WAS PROVIDED, AS THE "CYLINDER ERODED THROUGH THE CORPORA". AS REPORTED TO CO, THERE WERE NO REPORTS WITH REGARD TO DEVICE FUNCTION. THE ENTIRE DEVICE WAS REMOVED.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 3/1/90 AND REMOVED ON 7/15/96 BECAUSE A "CYLINDER ERODED THROUGH CORPORA," AND THAT THERE WERE NO PROBLEMS NOTED WITH THE DEVICE. IN THE RECEIVED INFO THE MD STATED THAT THE CYLINDER HAD ERODED AT THE "DISTAL RT CORPORA," AND THAT IT WAS "ABOUT TO ERUPT THROUGH THE SKIN." THE MD NOTED DURING SURGERY THAT A "TREMENDOUS AMOUNT OF SCARRING" WAS OBSERVED. THE MD FURTHER STATED THAT AN "ANATOMICAL DEFORMITY SEC TO PRIOR TRAUMA" MAY HAVE CONTRIBUTED TO THIS OCCURRENCE. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF EROSION, QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE MD'S OBSERVATIONS QA ACCEPTS THE REPORT OF EROSION AS THE REASON FOR SURGICAL INTERVENTION.
DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION-INADEQUATE RIGIDITY.
SPECKS OF BLOOD NOTED IN TUBING OF INTRA-ARTERIAL BALLOON PUMP. SURGEONS NOTIFIED OF POSSIBLE RUPTURE INTRA-ARTERIAL BALLOON. SURGEONS IN TO REMOVE BALLOON VIA EMERGENCY STERNIOTOMY IN PT ROOM. BALLOON NOTED TO HAVE A RUPTURE.
IT WAS REPORTED THAT ON 8/22/96, A PT WAS HAVING DIFFICULTY WITH THE PUMP. ON 8/23/96, FACILITY FOLLOWED UP WITH A CALL TO THE PT. IT WAS NOTED THAT THE PT WAS UNRESPONSIVE AND THAT THE PUMP TUBING WAS LEAKING. THE PUMP WAS REMOVED FROM THE PT ON 8/23/96. THE PHARMACIST FROM FACILITY TRIED PROGRAMMING THE PUMP IN ORDER TO DETERMINE THE PROBLEM. AFTER PROGRAMMING THE PUMP AND PLACING IT IN THE "PAUSE" MODE, THE PHARMACIST NOTED THAT THE PUMP BEGAN TO INFUSE AT AN ERRATIC RATE. THIS COULD HAVE RESULTED IN A SERIOUS INJURY TO THE PT.
IT WAS REPORTED BY THE PHARMACIST, IN A MED WATCH REPORT THAT THE PT WAS UNRESPONSIVE. AFTER SENDING A REPRESENTATIVE FROM CO TO THE FACILITY, IT WAS SPECULATED THAT THE PT'S UNRESPONSIVENESS WAS DUE TO OTHER MEDICATIONS, PROBABLY NOT TO AN OVER INFUSION OF THE MEDICATION VIA PUMP. ALSO, DAMAGE HAD OCCURRED TO THE TUBING, HENCE THE LEAKING. INDICATIONS ARE THAT THE PT IS THE LIKELY CAUSE OF THE DAMAGE. USING THE PRESCRIPTION FROM THE FACILITY REPORT, THE PUMP WAS INTERRUPTED DURING A RUN PROGRAM AFTER PRESSING MOST OF THE NON-FUNCTIONAL AND FUNCTIONAL KEYS TO DETERMINE WHAT SEQUENCE OF STEPS WOULD CAUSE A RESULT REPORTED BY CO. THIS EVALUATION CONFIRMED THE REPORT FROM CO AS REPORTED IN THE MED WATCH REPORT. EVALUATION OF THE PRODUCT WAS PERFORMED OVER A SERIES OF DAYS FROM 8/31/96 THROUGH 9/11/96.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO THE CYLINDERS DEFLATING DURING USE.
DURING A DIALYSIS TREATMENT, IT WAS REPORTED THAT THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE FAILED. THERE WAS NO FURTHER INFO AVAILABLE. THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD.
FAILURE OF THE ULTRAFILTRATION (UF) PUMP THERMAL FUSE. NO FURTHER INFO AVAILABLE FROM THE FACILITY. A REVIEW OF THE DTF AND CPF HISTORIES IS NOT POSSIBLE SINCE THE MACHINE SERIAL NUMBER IS NOT KNOWN. A SECONDARY SERACH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE TECHNICIAN AT THE FACILITY FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE FAILED THERMAL FUSE WAS NOT RETURNED FOR INVESTIGATION. IT HAS BEEN SEEN PREVIOUSLY THAT A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. THERE WERE TWO OTHER INCIDENTS REPORTED WITH THIS ONE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. CUSTOMER CONTACTED:N. SALES/SERVICE CONTACTED BY INVESTIGATOR:N. TRAINING REQUIRED:N.
PER THE INFO PROVIDED TO CO BY HOSPITAL, THE DEVICE WAS REMOVED DUE TO A "NON-FUNCTION", "DEVICE DID NOT WORK". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED.
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS IMPLANTED ON 8/5/87. REVISIONS OCCURRED ON 1/8/88 AND 9/10/96. THIS REPORT ADDRESSES THE 9/10/96 REVISION. THIS REVISION OCCURRED REPORTEDLY BECAUSE THE DEVICE "DID NOT WORK." THE RECEIVED OPERATIVE REPORT STATED THE FOLLOWING: THE DEVICE "WOULD PUMP UP ONLY PARTIALLY" AND "THERE WAS A LOSS OF SOME FLUID," THE PATIENT HAS A HISTORY OF "DIET CONTROLLED DIABETES," DURING SURGERY THE PHYSICIAN NOTED THAT "THE PATIENT WAS FOUND TO HAVE METAL CONNECTORS WHICH HAVE NOT BEEN USED FOR SOME TIME. IN FREEING UP THE TUBING TO THE PUMP SOME TUBING BROKE GOING TO ONE OF THE CYLINDERS FROM THE PUMP." THE PHYSICIAN FURTHER NOTED, "THE CYLINDER WAS THEN FILLED," AND "THERE APPEARED TO BE SOME DECREASE IN RIGIDITY AFTER APPROXIMATELY FIVE MINUTES. IT WAS DECIDED AT THIS POINT TO REPLACE THE ENTIRE PROSTHESIS AS IT WAS NOT EXACTLY EVIDENT WHERE THE LEAK MIGHT BE." TWO CYLINDERS, A PUMP, A RESERVOIR WITH AN ATTACHED CONNECTOR, TWO DETACHED CONNECTORS AND TWO REAR TIP EXTENDERS WERE RECEIVED. DURING FUNCTIONAL TESTING TWO LEAKAGE SITES WERE DETACHED IN THE RESERVOIR TUBING. ONE WAS NOTED NEAR RESERVOIR CAP. THE OTHER WAS LOCATED NEAR THE CONNECTOR. A MICROSCOPIC EXAMINATION OF THE LEAKAGE SITES WAS PERFORMED. BOTH LEAKAGE SITES SHOWED ROUGH, IRREGULAR TUBING ENDS, INDICATING A TUBING TEAR. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCE'S EXAMINATION, QA CONCLUDES THAT TWO LEAKAGE SITES EXISTED WITH THIS DEVICE. BOTH LEAKAGE SITES WERE CAUSED BY STRESS(ES) ASSOCIATED WITH DEVICE USAGE OVER TIME AND/OR STRESS(S) DURING EXPLANT SURGERY.
BILATERAL CAPSULECTOMIES WITH REMOVAL OF RIGHT RUPTURED IMPLANT AND LEFT INTACT IMPLANT.
INFORMATION ACQUIRED ON 10/16/96 INDICATES REASON AS DISTAL CORPORAL PERFORATION.
FACILITY ALLEGES A BLOOD LEAK OCCURRED ON A DIALYZER FIFTY MINUTES INTO TREATMENT. THE BLOOD LEAK WAS DETECTED BY A BLOOD LEAK ALARM, NO VISUAL BLOOD IN THE DIALYSATE. DIALYSIS WAS DISCONTINUED AND NO BLOOD LOSS REPORTED. BLOOD PRESSURE STABLE. THE DIALYSIS TREATMENT WAS RESUMED WITH ANOTHER DIALYZER AND COMPLETED WITH NO ADVERSE SYMPTOMS NOTED PRIOR TO THE PT LEAVING THE DIALYSIS UNIT ON 9/18/96. THE NEXT MORNING (9/19/96), THE PT COMPLAINED OF DIZZINESS, HEADACHE, INSOMNIA, NIGHTMARES, NAUSEA, VOMITING, ARTHRALGIA AND WHEEZING. THE PT'S EYES WERE RED. THE FACILITY HAS REPORTED THAT THE DIALYZER INVOLVED IN THE BLOOD LEAK INCIDENT HAD BEEN DISCARDED AND THERE ARE NO DIALYZERS FROM THE SAME LOT NUMBER AVAILABLE.
THE DIALYZER ALLEGEDLY INVOLVED IN THIS INCIDENT WAS A DIALYZER MFG IN 4/85. IT HAS BEEN REPORTED THAT AT THE TIME OF THIS DIALYSIS TREATMENT, A CART WAS BEING SPRAY PAINTED INSIDE THE DIALYSIS UNIT. ADD'L INFO WILL BE PROVIDED WHEN AVAILABLE.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO TUBING TEAR TO RESERVOIR.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL.
AT REOPERATION, ONE LEAFLET WAS STUCK IN THE CLOSED POSITION AND LEAFLET MOTION WAS REDUCED IN THE OTHER LEAFLET. A LEAFLET WAS FRACTURED WHILE ASSESSING LEAFLET FUNCTION. THE VALVE WAS EXPLANTED.
INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH CO SPECIFICATIONS AT THE TIME OF MFR. THE CO PHYSICIAN'S MANUAL CAUTIONS AGAINST UTILIZING FORCE AGAINST THE LEAFLETS, AS THIS MAY RESULT IN STRUCTURAL DAMAGE TO THE VALVE. THE MULTIPLE FRACTURE OBSERVED ON THE RIGHT LEAFLET WAS MOST LIKELY THE RESULT OF AN EXTERNAL FORCE COMING IN CONTACT WITH THE VALVE INTRAOPERATIVELY; SPECIFICALLY, DURING LEAFLET TESTING AT RE-OPERATION, AS SUGGESTED IN THE EVENT DESCRIPTION ON THE FORM. THE FRACTURE WAS NOT DUE TO AN INTRINSIC DEFECT IN THE VALVE. THE CAUSE OF THE LEAFLET ENTRAPMENT, WHICH WAS OBSERVED BY DR. AT RE-OPERATION, WAS MOST LIKELY DUE TO THROMBOSIS, AS SUPPORTED BY CO MANAGER AND PATHOLOGIST, BOTH OF WHOM DETECTED A REDDISH-BROWN MATERIAL, APPEARING TO BE THROMBUS, IN THE RECESSED PIVOT AREAS. HOWEVER, THE CAUSE OF THROMBOSIS REMAINS UNK DUE TO THE FACT CO DIVISION HAS NOT RECEIVED ADDITIONAL INFORMATION WHICH MAY HAVE AIDED IN THIS EVALUATION. PAGES = 3.
MAGNESIUM SULFATE WAS BEING ADMINISTERED BY PUMP. IT WAS SET TO DELIVER A 100CC BOLUS AND THEN TO BEEP SO THAT THE CONTINUOUS RATE COULD BE SET. WHEN IT BEEPED THE NURSE DISCOVERED THAT 250CC HAD BEEN INFUSED RESULTING IN THE PT RECEIVING 10 GMS OF MGSO4 RATHER THAN THE 4GMS ORDERED. THE INFUSION WAS STOPPED AND THE PUMP WAS REMOVED FROM SVC. THE PT WAS TREATED WITH CALCIUM GLUCONATE AND RECOVERED.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION. IMMEDIATE SALVAGE PROCEDURE. ADD'L LOT/SER #: BS254 009.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. TUBING HAD OR DAMAGE.
THE DEVICE WAS REMOVED DUE TO A "TUBING BREAK", SECONDARY TO A FLUID LOSS". AS REPORTED TO CO, IT WAS OBSERVED THAT "THE CYLINDER TUBING SHOWED WEAR ABOVE THE STRAIN RELIEF OF THE ROUND STYLE RELEASE PUMP". AS STATED IN THE OPERATIVE NOTES OBTAINED FROM THE PHYSICIAN'S OFFICE, "THERE WAS A BREAK IN THE TUBING AT THE LEVEL OF THE PUMP LEADING TO THE RIGHT CYLINDER RESULTING IN THE MALFUNCTION". ADDITIONALLY THE PHYSICIAN REPORTED THAT WHEN THE PT FIRST PRESENTED IN HIS OFFICE, HE REPORTEDLY HAS "EXPERIENCED SOME DISCOMFORT IN THE LEFT GROIN REGION". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH CO'S 3-PIECE INFLATABLE PENILE PROSTHESIS.
ACCORDING TO THE AVAILABLE INFORMATION, THIS PENILE PROSTHESIS WAS IMPLANTED ON 11/5/86. A REVISION OCCURRED ON 9/9/96, REPORTEDLY DUE TO A "FLUID LEAK." THE RECEIVED OPERATIVE NOTES STATED THAT, "THERE WAS A BREAK IN THE TUBING AT THE LEVEL OF THE PUMP LEADING TO THE RIGHT CYLINDER RESULTING IN THE MALFUNCTION." TWO CYLINDERS, A PUMP, AND A RESERVOIR WERE RECEIVED AND EVALUATED BY THE MFR. NO CONNECTORS WERE RECEIVED. THUS, THE ENTIRE DEVICE WAS NOT RECEIVED. THE RECEIVED COMPONENTS PASSED ALL FUNCTIONAL TESTS. THE CROSS SECTIONAL SURFACES OF THE DISTAL TUBING ENDS SHOWED UNIFORM STRIATIONS, INDICATING CONTACT WITH SHARP INSTRUMENTATION, E.G. SCALPEL, SCISSORS. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCE'S EXAMINATION, QA CONCLUDES THAT THE OBSERVED INSTRUMENT DAMAGE OCCURRED DURING OR SUBSEQUENT TO EXPLANT, AND THEREFORE, IS NOT RELATED TO THE COMPLAINT. SINCE QA DID NOT RECEIVE THE ENTIRE DEVICE, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE UNRECEIVED COMPONENTS. QA WAS UNABLE TO CONFIRM A BREAK IN THE TUBING OR A FLUID LEAK.
ECHOCARDIOGRAPHY WAS PERFORMED POSTOP WHICH REVEALED IMPEDED LEAFLET/S, AND ELEVATED GRADIENT. REOPERATION WAS PERFORMED AND THROMBUS WAS NOTED IN THE RECESSED PIVOT AREA. ANOTHER MECHANICAL HEART VALVE WAS IMPLANTED.
ON 9 SEPT., 1996, DR. IMPLANTED A 21MM AORTIC ST. JUDE MEDICAL MECHANICAL HEART VALVE (MODEL 21AEC-102). THE PATIENT HAD HISTORY OF CARDIOMYOPATHY, INFARCTED BOWEL, AND HAD HYPERTROPHIED SEPTUM AS WELL AS A HEAVILY CALCIFIED ANNULUS. INITIALLY, THE PATIENT DID WELL. HOWEVER, ECHOCARDIOGRAPHY WAS THEN PERFORMED WHICH REVEALED AN IMPEDED LEAFLET, AND ELEVATED GRADIENT (90MM HG). ON 17 SEPT., 1996, RE-OPERATION WAS PERFORMED AND THROMBUS WAS NOTED IN A RECESSED PIVOT AREA. DR. REMOVED EXCESS CALCIUM FROM THE ANNULUS AT THIS TIME, AND DID NOT HAVE A COMPLAINT ABOUT THE VALVE FUNCTION. THIS VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER ST. JUDE MEDICAL MECHANICAL HEART VALVE. INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE FER ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH ST. JUDE MEDICAL SPECIFICATIONS AT THE TIME OF MFR. RESULTS OF THIS INVESTIGATION INDICATED THAT THE IMPEDANCE OF THE LEAFLET WAS NOT DUE TO AN INTRINSIC DEFECT IN THE VALVE. RATHER, THE IMPEDANCE WAS MOST LIKELY DUE TO FIBRIN THROMBUS LODGED IN THE RECESSED PIVOT AREA, WHICH WAS SUPPORTED BY ANTHER DR. # PAGES = 2.
REMOVAL OF RUPTURED SALINE IMPLANT - RIGHT BREAST.
IAB S/N UNK. THE COLOR OF THE HEMOSTASIS VALVE AND THE DILATOR NUT ARE BOTH CLEAR WHEN IN THE DIMLY LIT CATHETER LAB. IT IS DIFFICULT TO REMOVE THE DILATOR FROM THE HEMOSTASIS VALVE BECAUSE THEY ARE BOTH THE SAME COLOR. BECAUSE BOTH ITEMS ARE THE SAME COLOR, IT IS UNCLEAR WHERE TO UNSCREW THE DILATOR. THE USER ENDS UP REMOVING THE HEMOSTASIS VALVE FROM THE SHEATH CAUSING MORE BLEEDING THAN USUALLY EXPECTED.
THE PRODUCT HAS NOT BEEN RETURNED TO CO FOR EVAL. A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. THIS FORM WAS COMPLETED BY THE MFR. IT WAS NOT DETERMINED UNTIL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96, THAT THIS WAS A 5 DAY REPORTABLE MDR. THEREFORE, THIS IS NOT AN OVERDUE MDR. ALL FUTURE SIMILIAR COMPLAINTS WILL BE REPORTED WITHIN 5 WORKING DAYS.
FACILITY ALLEGED A BLOOD LEAK OCCURRED ON A DIALYZER FIVE MINUTES ONTO TREATMENT. THE BLOOD LEAK WAS DETECTED BY A BLOOD LEAK ALARM, NO VISUAL BLOOD IN THE DIALYSATE. DIALYSIS WAS DISCONTINUED AND BLOOD RETURNED TO THE PT; THEREFORE NO BLOOD LOSS OCCURRED. BLOOD PRESSURE STABLE. THE DIALYSIS TREATMENT RESUMED WITH ANOTHER DIALYZER AND COMPLETED WITH NO ADVERSE SYMPTOMS NOTED PRIOR TO THE PT LEAVING THE DILAYSIS UNIT ON 9/18/96. THE NEXT MORNING (9/19/96) THE PT COMPLAINED OF HEADACHE, INSOMNIA, NIGHTMARES, NAUSEA, AND VOMITING. THE PT'S EYES WERE RED AND SHE COMPLAINED OF VISION PROBLEMS. THE FACILITY REPORTED THAT THE DIALYZER INVOLVED IN THE BLOOD LEAK INCIDENT HAD BEEN DISCARDED AND THERE ARE NO DIALYZERS FROM THE SAME LOT NUMBER AVAILABLE.
PER THE INFO PROVIDED TO CO BY HOSPITAL, THE DEVICE WAS REMOVED DUE TO A "CRACK IN THE TUBING FROM THE PUMP TO THE CYLINDER". AS REPORTED TO CO, THE CYLINDER(S), PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED WITH ANOTHER PUMP AND CYLINDER ASSEMBLY.
ACCORDING TO THE AVAILABLE INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 3/23/1994. IT WAS EXPLANTED ON 9/9/1996, REPORTEDLY DUE TO A "CRACK IN BETWEEN THE PUMP AND CYLINDER." IN THE RECEIVED QUESTIONNAIRE, THE PHYSICIAN INDICATED THE FOLLOWING: THERE WAS A SPECIFIC LEAKAGE SITE OBSERVED "NEAR PUMP ON TUBING TO A CYLINDER," THE TUBING WAS NEITHER KINKED OR TWISTED WHEN HE OPENED THE POCKET, WHEN IMPLANTED NO EXESSIVE NOR INADEQUATE TUBING LENGHTS WERE OBSERVED, NOTHING WAS NOTED IN THE POSITIONING THAT MAY HAVE CAUSED STRESS(ES) TO THE DEVICE, AND THE DEVICE DID NOT CONTACT ANY UNSHOD, SHARP INSTRUMENTATION DURING OR SUBSEQUENT TO REMOVAL. THE TWO CYLINDERS AND THE PUMP WERE RECEIVED AND EVALUATED BY THE MFR. THE COMPONENTS PASSED ALL FUNCTIONAL TESTS. A MICROSCOPIC EXAMINATION OF THE TUBING ENDS SHOWED UNIFROM STRIATIONS ON THE SURFACES, INDICATING CONTACT WITH SHARP INSTURMENTATION, E.G. SCALPEL, SCISSORS. BASED ON THE DURATION THE DEVICE WAS IMPLANTED, QUALITY ASSURANCE CONCLUDES THAT THE CONTACT WITH SHARP INSTRUMENTATION OCCURRED DURING OR SUBSEQUENT OT EXPLANT SURGERY, AND THIS, IS NOT RELATED TO THE COMPLAINT. QA CAN NOT CONFIRM THE REPORTED CRACK IN BETWEEN THE PUMP AND CYLINDER.
ONCE IMPLANTED, THE LEAFLETS WOULDN'T OPEN PROPERLY. THE VALVE WAS EXPLANTED AND REPLACED WITH A MECHANICAL HEART VALVE MODEL 21 A-101.
INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH CO SPECIFICATIONS AT THE TIME OF MFR. RESULTS OF THIS INVESTIGATION REMAIN INCONCLUSIVE DUE TO THE FACT CO HAS NOT RECEIVED ADDITIONAL INFORMATION WHICH MAY HAVE AIDED IN THE EVALUATION OF THE VALVE. THE CAUSE OF THE IMPEDED LEAFLETS, WHICH WAS OBSERVED INTRAOPERATIVELY, REMAINS UNK. HOWEVER, IT WAS NOT DUE TO AN INTRINSIC VALVE DEFECT, AS SUPPORTED BY TESTING PERFORMED AT CO.
SOMETIME IN 1985 DEVICE WAS IMPLANTED. ON 9/4/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
FACILITY ALLEGED A BLOOD LEAK OCCURRED ON A DIALYZER TWO HOURS AND 47 MINUTES INTO TREATMENT. THE BLOOD LEAK WAS DETECTED BY A BLOOD LEAK ALARM, NO VISUAL BLOOD IN THE DIALYSATE. DIALYSIS WAS DISCONTINUED AND BLOOD RETURNED TO THE PT; THEREFORE NO BLOOD LOSS OCCURRED. BLOOD PRESSURE STABLE. THE DIALYSIS TREATMENT WAS RESUMED WITH ANOTHER DIALYZER AND COMPLETED WITH NO ADVERSE SYMPTOMS NOTED PRIOR TO THE PT LEAVING THE DIALYSIS UNIT ON 9/18/96. THE NEXT MORNING (9/19/96), THE PT COMPLAINED OF HEADACHE, DIZZINESS, NAUSEA, VOMITING, AND HEARING LOSS. THE PT'S EYES WERE RED AND SHE COMPLAINED OF VISION PROBLEMS. THE FACILITY HAS REPORTED THAT THE DIALYZER INVOLVED IN THE BLOOD LEAK INCIDENT HAD BEEN DISCARDED AND THERE ARE NO DIALYZERS FROM THE SAME LOT NUMBER AVAILABLE.
PT INVOLVED IN THIS INCIDENT DIED ON 1/24/97. ACCORDING TO THIS PT'S PHYSICIAN, HEART FAILURE WAS THE CAUSE OF DEATH. IN A LOCAL NEWPAPER, THIS PT'S DR SAID "TH MYSTERIOUS ILLNESS AFTER DIALYSIS (ON 9/18/96) WAS UNRELATED TO HER DEATH."
FIRST PROCEDURE WAS AT 8:00 A.M. RIGHT HEMI-COLECTOMY DUE TO ADENO-CARCINOMA. RECTAL BLEEDING POST-OP REQUIRED RE-ADMITTANCE TO THE O.R. AT 1:55 P.M. INSPECTION OF OUTSIDE OF ILEO-COLOTIC ANASTOMOSIS REVEALED NO BLEEDING. ANATOMOSIS WAS DISMEMBERED AND A HAND ANATOMSIS WAS PERFORMED. THE COLOTOMY WAS ALSO RE-DONE BY HAND SUTURES WITH 3/0 SUTURES. PT WAS THEN DISCHARGED ON 7/26/96.
THE HANDLE OF THIS PAIR OF SCISSORS BROKE OFF WHILE DISSECTING SOFT TISSUE. ANOTHER PAIR OF SCISSORS WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A-F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. SECITON F.9 IS DATE USER BECAME AWARE OF THE FAILURE. THE BLADES OF THIS PAIR OF SCISSORS ARE IN POOR CONDITION. NICKS ARE PRESENT ON THE BLADES. THIS PAIR OF SCISSORS APPEARS TO HAVE BEEN ABUSED.
FACILITY ALLEGES A BLOOD LEAK OCCURRED ON A DIALYZER ONE HOUR AND 40 MINUTES INTO TREATMENT. THE BLOOD LEAK WAS DETECTED BY A BLOOD LEAK ALARM, NO VISUAL BLOOD IN THE DIALYSATE. DIALYSIS WAS DISCONTINUED AND BLOOD RETURNED TO THE PT; THEREFORE NO BLOOD LOSS OCCURRED. BLOOD PRESSURE STABLE. THE DIALYSIS TREATMENT WAS RESUMED WITH ANOTHER DIALYZER AND COMPLETED WITH NO ADVERSE SYMPTOMS NOTED PRIOR TO THE PT LEAVING THE DIALYSIS UNIT ON 9/18/96. ALSO DURING PT'S TREATMENT, A DR WAS DEBRIDING AN OPEN WOUND ON HIS LEG. DURING THE NIGHT, THE PT AWOKE AND COMPLAINED OF VISION PROBLEMS AND HEARING LOSS. THE PT'S EYES WERE RED. THE FACILITY REPORTED THAT THE DIALYZER INVOLVED IN THE BLOOD LEAK INCIDENT HAS BEEN DISCARDED AND THERE ARE NO DIALYZERS FROM THE SAME LOT NUMBER AVAILABLE.
THE PT DIED ON 10/7/96 AS REPORTED BY HOSP. IT HAS BEEN REPORTED BY THE HOSP ADMINISTRATOR THAT THE PT'S DEATH "WAS NOT NECESSARILY RELATED TO THE BLOOD LEAK INCIDENT." BEFORE DIALYSIS ON 9/18/96, PT WAS BEING TREATED FOR OSTEOMYELITIS, SEPTICEMIA, DIABETES AND A BURN WOUND.
THE CUSTOMER REPORTED THAT WHILE RUNNING TWO CONSECUTIVE HCV ASSAY PLATES, THE SAMPLE HANDLER DID NOT PIPETTE SAMPLE OR DILUENT IN POSITION A11. AN ERROR MESSAGE WAS NOT GENERATED EITHER TIME. AN ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
FACILITY ALLEGES A BLOOD LEAK OCCURRED ON A DIALYZER 35 MINUTES INTO TREATMENT. THE BLOOD LEAK WAS DETECTED BY A BLOOD LEAK ALARM, NO VISUAL BLOOD IN THE DIALYSATE. DIALYSIS WAS DISCONTINUED AND BLOOD RETURNED TO THE PT; THEREFORE NO BLOOD LOSS OCCURRED. BLOOD PRESSURE STABLE. THE DIALYSIS TREATMENT WAS RESUMED WITH ANOTHER DIALYZER AND COMPLETED WITH NO ADVERSE SYMPTOMS NOTED PRIOR TO THE PT LEAVING THE DIALYSIS UNIT ON 9/18/96. THE NEXT MORNING (9/19/96), THE PT COMPLAINED OF HEADACHE, DIZZINESS, AND WHEEZING. THE PT'S EYES WERE RED. THE FACILITY REPORTED THAT THE DIALYZER INVOLVED IN THE BLOOD LEAK INCIDENT HAD BEEN DISCARDED AND THERE ARE NO DIALYZERS FROM THE SAME LOT NUMBER AVAILABLE.
THE WELD ON THIS MOUTH GAG IS CRACKED UNDERNEATH THE LEVER AND DOES NOT PROVIDED TENSION FOR RATCHET. IT WILL NOT HOLD THE TONGUE BLADE IN PLACE. ANOTHER MOUTH GAG WAS USED FOR THE PROCEDURE.
SECTIONS A-F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. INSTRUMENT HAS NOT YET BEEN RECEIVED FOR EVAL. IF IT IS, RESULTS OF EVAL WILL BE FORWARDED AS FOLLOW-UP TO THIS REPORT.
PT WAS BROUGHT IN FOR INITIAL POSSIBLE APPENDECTOMY. MASS WAS DETERMINED UPON EXPLORATORY OPERATION AND REMOVED. RUPTURED MECKEL'S WAS RESULT (PURSUING PATHOLOGY REPORT) OR ILEO DIVERTICULUM PERFORATION AND ABCESS. A RESECTION OF MASS AND SURROUNDING ILEUM COLON WAS PERFORMED. AN ILEO-COLONOSTOMY WAS PERFORMED USING THE STAPLER. POST-OP DIAGNOSIS ON THE FOURTH DAY WITH HEMOGLOBIN AND HEMATOCRIT DROPPING SO DRASTICALLY AND WAS HAVING BLOODING STOOLS. DECISION WAS MADE TO REOP. EXTERNALLY, ANASTOMOSIS WAS INTACT WITH NO BLEEDING. CAPILLARY OOZING WAS CONFIRMED AND SUTURED MANUAL WITH OVERSEWING OF COLOTOMY.
HYPERGLYCEMIA: ACIDOSIS DIABETIC: A WOMAN REPORTED THAT THREE WEEKS AFTER SHE SWITCHED FROM INSULIN SYRINGES AND VIALS OF ANOTHER DEVICE TO DEVICE,  SHE STARTED TO EXPERIENCE ELEVATED BG LEVELS. SHE WAS HOSPITALIZED ONE WEEK LATER FOR DIABETIC KETOACIDOSIS. AFTER FOUR DAYS SHE WAS DISCHARGED AND RESUMED USE OF THE DEVICE. THREE DAYS LATER HER BG LEVELS STARTED TO ELEVATE AND REMAINED ELEVATED UNITL SHE WENT TO THE ER. SHE WAS TREATED IN THE ER AND RELEASED AND ONCE AGAIN RESUMED USE OF THE DEVICE. WHEN HER BG LEVELS STARTED TO ELEVATE AGAIN, SHE FELT THAT THE PROBLEM WAS DUE TO THE FUNCTIONING OF THE DEVICE. THE WOMAN STATED THAT SHE WAS REMOVING THE INSULIN CARTRIDGE AFTER EACH INJECTION TO REFRIGERATE IT AND THEN PRIOR TO REPLACING THE CARTRIDGE IN THE DEVICE FOR HER NEXT DOSE, SHE WOULD RESET THE PISTON ROD ON THE DEVICE. SHE CANNOT REMEMBER IF SHE DID AN AIR SHOT BEFORE EACH INJECTION AND HAD NEVER DONE A FUNCTION CHECK ON THE DEVICE. ANALYSIS REPORT: NO FAULT WAS FOUND UPON EXAMINATION OF THE DEVICE AND THE DEVICE PASSED A WEIGHT ACCURACY TEST UPON RECEIPT OF THE DEVICE. A GAP WAS NOTED BETWEEN THE RUBBER PISTON ON THE INSULIN CARTRIDGE AND THE PISTON ROD. THIS INDICATES THAT THE DEVICE WAS NOT USED ACCORDING TO THE INSTRUCTIONS.
IS THE EVENT LISTED IN INSERT? NO. IS THE EVENT OCCURRING MORE FREQUENTLY? N. IS THE EVENT'S SEVERITY LISTED IN INSERT? N. IS THE SEVERITY OCCURRING MORE FREQUENTLY? N.
SOME OF THE PLATING CAME FREE FROM THIS INSTRUMENT, ENTERED THE WOUND AND WAS SEEN ON THE IRIS. A NEW I/A NEEDLE WAS BROUGHT INTO THE CASE. MOST OF THE FLAKES WERE REMOVED FROM THE WOUND AND THE IRIS; HOWEVER, 1-2 TINY FLECKS REMAINED IN THE IRIS DESPITE REPEATED ATTEMPTS TO REMOVE THEM.
SECTION A-F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECITON F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. INSTRUMENT HAS NOT YET BEEN RECEIVED FOR EVAL. IF IT IS, RESULTS OF EVAL WILL BE FORWARDED AS FOLLOW-UP TO THIS REPORT.
FACILITY ALLEGES A BLOOD LEAK OCCURRED ON A DIALYZER NINE MINUTES INTO TREATMENT. THE BLOOD LEAK WAS DETECTED BY A BLOOD LEAK ALARM, NO VISUAL BLOOD IN THE DIALYSATE. DIALYSIS WAS DISCONTINUED AND NO BLOOD LOSS REPORTED. BLOOD PRESSURE STABLE. THE DIALYSIS TREATMENT WAS RESUMED WITH ANOTHER AND COMPLETED WITH NO ADVERSE SYMPTOMS NOTED PRIOR TO THE PT LEAVING THE DIALYSIS UNIT ON 9/18/96. THE NEXT MORNING (9/19/96), THE PT COMPLAINED OF HEADACHE, INSOMNIA, NIGHTMARES, ARTHRALGIA, WHEEZING AND LETHARGY. THE PT'S EYES WERE RED AND HE COMPLAINED OF VISION PROBLEMS. THE FACILITY HAS REPORTED THAT THE DIALYZER INVOLVED IN THE BLOOD LEAK INCIDENT HAD BEEN DISCARDED AND THERE ARE NO DIALYZERS FROM THE LOT NUMBER AVAILABLE.
THE DIALYZER ALLEGEDLY INVOLVED IN THIS INCIDENT WAS A DIALYZER MFG BY CD CO IN 4/85. IT HAS BEEN REPORTED THAT AT THE TIME OF THIS DIALYSIS TREATMENT, A CART WAS BEING SPRAY PAINTED INSIDE THE DIALYSIS UNIT. ADD'L INFO WILL BE PROVIDED WHEN AVAILABLE.
WHILE PREPARING TO PLACE A FILTER VIA THE JUGULAR APPROACH, THE VASCULAR DILATOR USED TO DILATE THE INSERTION SITE PERFORATED THE PT'S RIGHT VENTRICLE TWICE. OPEN HEART SURGICAL REPAIR FOLLOWED, THE PT EXPIRED THE FOLLOWING DAY. INFO COULD NOT BE OBTAINED REGARDING HOW THE INSERTION SITE DILATOR WAS ADVANCED TO THE LEVEL OF THE RIGHT VENTRICLE. DILATORS ARE RECOMMENDED IF INTRODUCTION OF THE CATHETER INTO THE VESSEL IS DIFFICULT. CO'S DIRECTIONS FOR USE STATE: "IN SOME CASES, SEQUENTIAL DILATATION WITH STANDARD VASCULAR DILATORS MAY BE NECESSARY PRIOR TO INSERTION OF THE 12 FR SHEATH/DILATOR." NO MALFUNCTION OF THE DEVICE HAS BEEN REPORTED. CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE.
THREE OF THE FIVE PAGES OF THE USER FACILITY MEDWATCH FOR WERE FORWARDED TO THIS MFR AND ARE ATTACHED.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORT #M570117.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF.  MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.
STAFF MEMBERS ARRIVED AT THE SCENE TO FIND A DOCTOR PERFORMING CPR ON A MALE PT. THE UNIT WAS ATTACHED TO THE PT AND THE STAFF ANALYZED THE PT'S RHYTHM. THE PT WAS IN V-FIB AND THE UNIT ADVISED THE STAFF TO DEFIBRILLATE THE PT. THE PT WAS DEFIBRILLATED ONCE AT 200J. THE UNIT DID NOT ADVISE A SECOND DEFIBRILLATION ATTEMPT. WHEN THE STAFF ATTEMPTED TO RUN A SUMMARY REPORT, THE UNIT WOULD NOT PRINT THE REPORT. THE UNIT'S MONITOR SCREEN WENT BLANK AND THE STAFF COULD HEAR A "BUZZING NOISE" COMING FROM THE UNIT. THEY DISCONNECTED THE PT FROM THE UNIT. THE PT SUBSEQUENTLY EXPIRED. THE COMPLAINANT INDICATED THAT THE PT HAD A HISTORY OF CARDIAC PROBLEMS AND THAT THE ALLEGED MALFUNCTION DID NOT CONTRIBUTE TO THE PT OUTCOME.
DISLOCATED IN THE PT'S EYE. ACCORDING TO THE PHYSICIAN, A ONE PIECE DEVICE WAS IMPLANTED IN THE PT'S RIGHT EYE FOLLOWING CATARACT EXTRACTION. POST-OPERATIVELY, THIS WOMAN EXPERIENCED NAUSEA AND VOMITING AND DID NOT REPORT THE SYMPTOMS TO THE PHYSICIAN. THE PHYSICIAN EXAMINED HER ON 8/28/96 AND THE LENS WAS DISLOCATED. SHE WAS TAKEN TO SURGERY FOR A LENS REPLACEMENT. IT WAS NOTED DURING THE SECONDARY SURGERY THAT THE CAPSULAR BAG HAD RUPTURED AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED. THE PT HAS SINCE RECOVERED. THE PHYSICIAN INDICATED THE LENS DISLOCATED WAS SECONDARY TO THE PT'S NAUSEA AND VOMITING. EVALUATION OF THE RETURNED LENS IS PENDING.
PT WAS SEEN FOR SEVERE PAIN AND DIFFICULTY WALKING. X-RAYS REVEALED A FRACTURE OF THE PROSTHESIS AND THE PROXIMAL PART OF THE FEMORAL PROSTHESIS WAS LOOSE.
RESISTANCE WAS MET UPON REMOVAL ATTEMPTS OF THE GUIDEWIRE USED FOR FILTER PLACEMENT FOLLOWING DEPLOYMENT VIA A JUGULAR APPROACH. CONTINUAL EXERTION UPON THE GUIDEWIRE AGAINST RESISTANCE RESULTED IN UNRAVELLING OF THE GUIDEWIRE AND SUBSEQUENT DETACHMENT OF A PORTION OF THE WIRE NEAR THE DISTAL TIP. THE PT WAS TRANSFERRED TO ANOTHER FACILITY WHERE THE PORTION OF WIRE WAS SUCCESSFULLY REMOVED VIA A FEMORAL APPROACH. THE FILTER PLACEMENT WAS SUCCESSFUL AND NO PT SEQUEALE RESULTED FROM THIS EVENT.
THE ABUTMENT LOCATED IN THE #30 AREA, BROKE IN FUNCTION. THE PT DIDN'T SAY IT WAS LOOSE OR ANY INDICATIONS THAT IT WAS A PROBLEM. PT CAME INTO THE OFFICE WITH THE CROWN IN LAND. PT IS REPORTEDLY FINE.
DURING INSPECTION THE PART WAS DETERMINED TO BE PART NUMBER 0613, NOT 0614 AS ORIGINALLY REPORTED. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
CHIEF TECH REPORTED THAT A BLOOD LEAK OCCURRED DURING HEMODIALYSIS TREATMENT. THE INCIDENT WAS DESCRIBED AS A FIBER LEAK. EBL 250-300CC. THE SAMPLE WAS DISCARDED BY THE FACILITY.
THIS EVENT WAS REPORTED AS A PORTION OF THE GRAFT WAS EXCISED FOR CONVERSION TO AN AXILLARY BYPASS. NO FURTHER INFO PROVIDED.
FACILITY REPORTED THAT UPON INITIATION OF TREATMENT, A SIGNIFICANT AND NOTICABLE BLOOD LEAK OCCURRED AT THE ARTERIAL END OF THE DIALYZER INTO THE DIALYSATE. TREATMENT WAS STOPPED AND THE PT'S ARTERIAL BLOOD WAS RINSED BACK. EBL 75-150CC. TREATMENT WAS RESUMED USING A NEW DIALYZER WITHOUT INCIDENT. SAMPLE WAS DISCARDED BY THE FACILITY.
A PT NOTICED THAT THE ABUTMENT WAS LOOSE AND THE PT WENT TO SEE DOCTOR. DR TRIED TIGHTENING IT AND THEN SENT THE PT HOME ONLY TO HAVE THE PT RETURN WITH THE ABUTMENT IN HAND.
THE PATIENT WAS IMPLANTED BILATERALLY WITH DEVICE ON 8/30/90. SUBSEQUENTLY THE DOCTOR NOTED THAT THE PATIENT HAD DEVELOPED BREAST PAIN IN HER LEFT BREAST AND BREAST PAIN, SWELLING, AND EXTRUSION IN HER RIGHT BREAST.  NO ADDITIONAL INFORMATION REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (MENTOR EFFECTIVE DATE, FEBRUARY 10, 1992). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21CFR803."SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFORMATION CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO.
CHIEF TECH REPORTED THAT A BLOOD LEAK OCCURRED DURING TREATMENT. THE LEAK WAS DESCRIBED AS A FIBER LEAK. EBL>250CC. THE SAMPLE WAS DISCARDED BY THE FACILITY.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE PT IS A SMOKER WHICH THE DR INDICATED AS A CONTRIBUTING FACTOR.
86= DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED. 100=REVIEW OF DEVICE HISTORY RECEORD SHOWED THAT THE LOT MET SPECIFICATIONS PRIOR TO SHIPMENT.
PT WAS UNDERGOING CABG PROCEDURE USING A OXYGENATOR AND THE CO DEVICE IN A HEPARINIZED CIRCUIT. CLINICIAN PREPARING LIMA PRIOR TO THE START OF THE CABG PROCEDURE. IT WAS REPORTED THAT THERE WAS NO VENOUS CANULATION IN THE RIGHT ATRIUM OR IVC/SVC. DURING THE LIMA PROCEDURE THE PT ARRESTED. A VENT SUCKER WAS INSERTED INTO THE RIGHT ATRIUM DIRECTLY TO PROVIDE SOME VENOUS RETURN TO THE OXYGENATOR. AFTER INITIATING VENOUS RETURN TO THE CARDIOTOMY FILTER, A NON-VENTED CAP BLEW OFF THE TOP OF THE DEVICE. BLOOD LOSS TO THE FLOOR PROMPTED AN OXYGENATOR-CHANGE-OUT, TO ANOTHER CO'S BUBBLE OXYGENATOR. PT STILL ON BYPASS AND CABG PROCEDURE. IT WAS SUBSEQUENTLY REVEALED THAT THE PT EXPIRED.
LOCKING BOLT BROKE AT THE PROXIMAL THREAD.
IMPLANT WAS EXPLANED DUE TO INADEQUATE OSTEOINTEGRATION. BONE LOSS WAS NOTED.
86= DIMENSIONAL ANALYSIS, 100= THE RETURNED COMPONENT MET INTERPORE VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
CUSTOMER REPORTED THAT WHILE RUNNING HCV AND HEPATITIS CORE ASSAYS, THE HANDLER SCANNED POSITION B6 TWICE AND DID NOT GENERATE AN ERROR MESSAGE. THE CUSTOMER ABORTED THE PLATE. AN ENGINEER WAS DISPATCHED TO EVALUATE THE INSTRUMENT. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
IMPLANT WAS EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. THE IMPLANT WAS ATTACHED TO A BRIDGE AND HE DR INDICATED THAT TOO SHORT OF AN IMPLANT LEADING TO OCCLUSIONAL STRESS ON THE BRIDGE AS A CONTRIBUTING FACTOR.
86= DIMENSIONAL ANALYSIS. 100= THE RETURNED COMPONENT MET INTERPORE VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS. 68= THE DR INDICATED THAT THE IMPLANT MAY HAVE BEEN TOO SHORT FOR THE RESTORATION AND OCCLUSAL STRESS ON THE BRIDGE CONTRIBUTED TO THE IMPLANT LOSS.
THE PT, A IDDM, BEGAN FEELING ILL WITH SYMPTOMS OF HYPERGLYCEMIA ON 8/19/96. SHE HAD BEEN OBTAINING READINGS ON HER METER USING DIFFERENT BRAND TEST STRIPS (LOT # 1J5208, EXP 5/97) OF "35, 40" MG/DL. SHE CONTACTED A NURSE WHO ADVISED HER TO DRINK ORANGE JUICE BASED UPON THE RESULTS. FEELING WORSE, SHE WENT TO THE HOSP WHERE A LAB RESULT WAS "IN THE 800'S." THE PT WAS ADMITTED FOR HYPERGLYCEMIA ON 8/19, TREATED WITH INSULIN AND IV, AND RELEASED ON 8/24. A METER TO METER COMPARISON WAS PERFORMED IN THE HOSP (USING STRIPS PROVIDED BY THE HOSP) WITH THE PT'S METER READING 177 MG/DL AND THE HOSP METER (BRAND UNK) READING 200 MG/DL, AN 11% DIFFERENCE. THE METER IS NOT CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, NO WATER IS USED TO CLEAN THE METER OPTICS. CALIBRATION STATUS ON 9/6 WAS 74 VERSUS A RANGE OF 66-89.
CO HAS COMPLETED THE REPORT OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNK ANOMALY. AT THIS POINT THE INVESTIGATION OF THIS MATTER IS CLOSED.
PT ADMITTED, FROM NURSING HOME, ON 8/15/96 WITH FUO, ALTERED MENTAL STATUS AND SEPTIC WORK-UP. HOSP LOS UNEVENTFUL. TREATED WITH ANTIBODIES. 8-23-96 LEFT VENTRICULOSTOMY-INSERTED. 8-31-96 RIGHT VENTRICULOSTOMY REPLACED. 9/11/96 LEFT VENTRICULOSTOMY REPLACED. 9/13/96 NURSE FOUND EXTERNAL DRAINAGE LOST APPROX 300-350 CC. CEREBROSPINAL FLUID (CSF). ADHESIVE TAPE USED TO HOLD TUBING IN PLACE CAME LOOSE. QUESTIONABLE IF DRAINAGE COLLECTION KIT IS DEVICE FAILURE. ADHESIVE TAPE FAILED. ON 9/17/96 PT EXPIRED.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. A FISTULA DEVELOPED AND THE IMPLANT DID NOT INTEGRATE. INFECTION WAS NOTED. THE PT WORE A SOFT RELINED DENTURE DURING THE HEALING PHASE. THE DR INDICATED THAT PRESSURE FROM THE DENTURE MAY HAVE BEEN A CONTRIBUTING FACTOR.
PT WAS HAVING PTCA OF 2 VESSELS. STENT PLACEMENT X2. SUBSEQUENT TO FINAL PICTURES BEING TAKEN, THE DISTAL END OF THE WIRE WAS FOUND AT THE END OF THE CORONARY ARTERY. THE REMAINING PIECE WAS RETRIEVED WITH A MICROSNARE.
INFO WAS RECEIVED REGARDING A PT TESTED INTRAPARTUM USING THE DEVICE GBS ASSAY LOT NUMBER 690445. THE PT WAS TESTED DURING LABOR AT 5:30 AM AND DURING DELIVERY AT 11:30 PM ON 9/8/96. DUPLICATE SPECIMENS OBTAINED AT THE SAME TIME WERE USED TO STREAK CULTURE PLATES. THE RESULTS OF THE ASSAYS WERE NEGATIVE. NO ANTIBIOTIC TREATMENT WAS ADMINISTERED TO THE PT BASED ON THE RESULTS. THE CULTURE RESULTS WERE POSITIVE FOR GROUP B STREP. THE CULTURES WERE CONFIRMED WITH A STREP TYPING KIT, MFR UNKNOWN AND BY BACKTYPING USING THE GBS ASSAY. THE INFANT DELIVERED FROM THIS PT WAS SENT TO THE NEONATAL UNIT DUE TO RESPIRATORY DISTRESS. THE BLOOD CULTURE FROM THIS INFANT WAS POSITIVE FOR GBS. THE INFANT IS NOW DOING FINE. NO SAMPLE OR KIT WAS RECEIVED FROM THE CUSTOMER FOR TESTING; THEREFORE, THE COMPLAINT FOR CULTURE POSITIVE, NEGATIVE COULD NOT BE EVALUATED. TESTING WAS PERFORMED AT CO USING AN IN-HOUSE KIT OF THE SAME LOT NUMBER. REFER TO SECTION H10 FOR TEST RESULTS.
THE SUBMISSION OF THIS MEDICAL DEVICE REPORT IS REQUIRED OF DEVICE MFRS BY 21CFRPART803. NEITHER THE SUBMISSION OF INFO BY CO PURSUANT TO THIS RULE, NOR THE PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CONNECTION BETWEEN THE PRODUCT AND ANY DEATH OR INJURY. CONTINUATION OF SECTION B5: TESTING WAS PERFORMED AT CO USING A IN-HOUSE KIT OF THE SAME LOT NUMBER. NEGATIVE CONTROL, POSITIVE CONTROL AND A SENSITIVITY SAMPLE WERE TESTED AND PRODUCED THE FOLLOWING RESULTS. SAMPLE; EXPECTED RESULTS; CO'S RESULTS; NEGATIVE CONTROL, 1/1 VISUALLY NEGATIVE, 1/1 VISUALLY NEGATIVE, POSITIVE CONTROL, 1/1 VISUALLY POSITIVE, 1/1 VISUALLY POSITIVE, SENSITIVITY SAMPLE, 3/3 VISUALLY POSITIVE, 2/3 VISUALLY POSITIVE. THE STREP B LABELING CLEARLY SPECIFIES THAT NEGATIVE RESULTS MUST BE CONFIRMED WITH CULTURE. FOLLOWING IS THE LIMITATIONS SECTION FROM THE STREP B DIRECTIONAL INSERT: VAGINAL AND CERVICAL SPECIMENS; THE STREP B ASSAY IS INTENDED TO AID IN THE DETECTION OF GROUP B STREPTOCOCCUS ANTIGEN FROM VAGINAL OR CERVICAL SWAB SPECIMENS OBTAINED FROM PRETERM AND INTRAPARTUM MATERNITY PTS. STREP B IS NOT INTENDED FOR DISTINGUISHING WHETHER THE SPECIMEN IS FROM A COLONIZED OR AN INFECTED INDIVIDUAL. STREP B IS NOT INTENDED TO BE USED AS A SUBSTITUTE FOR BACTERIAL CULTURE. NEGATIVE RESULTS USING STREP B ASSAY MUST BE CONFIRMED WITH CULTURE. STREP B ASSAY RESULTS MUST ALWAYS BE INTERPRETD BY THE PHYSICIAN IN CONJUNCTION WITH OTHER PERTINENT CLINICAL AND LABORATORY DATA.
IMPLANT WAS EXPLANTED DUE TO INADEQAUTE OSTEOINTEGRATION. THE DR INDICATED THAT PERI-IMPLANTITIS (INFECTION) WAS INVOLVED.
86= DIMENSIONAL ANALYSIS. 100= THE RETURNED COMPONENT MET INTERPORE VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
EXTERNAL DRAINAGE SYSTEM WAS MOUNTED TO AN IV POLE USING TAPE. IT IS LIKELY THAT THE TAPE FAILED AND CAUSED THE DRIP CHAMBER TO FALL OFF AND THE PT LOST APPROX 300 CC OF CSF DUE TO OVERDRAINAGE. ALTHOUGH THE PT WAS ALERT AND RESPONSIVE AT THE TIME OF THE INITIAL INCIDENT, THE PT DIED THREE DAYS LATER. AUTOPSY REVEALED SUBDURAL HEMATOMA AS CAUSE OF DEATH. IT IS BELIEVED THAT THE TAPE USED TO HOLD THE BAG ONTO THE IV POLE FAILED, NOT THE BAG OR THE SYSTEM ITSELF. ALSO, IT IS LIKELY THE TAPE HAD BEEN RE-USED SEVERAL TIMES AS THE PT WAS REPOSITIONED SEVERAL TIMES.
SINCE THE DEVICE WAS DISCARDED BY THE USER FACILITY, NO EVAL IS POSSIBLE. HOWEVER, THE USER FACILITY APPARENTLY BELIEVES THE FAILURE WAS CAUSED BY THE DETACHMENT OF THE TAPE USED TO SECURE THE DRAINAGE BAG TOT HE IV POLE.
UPON X-RAY THE HOSP FOUND THAT THE DISTAL TIP OF THE SPRING WIRE GUIDE HAD SEPARATED IN THE PT'S PULMONARY ARTERY. AT THIS TIME THE SEPARATED PORTION OF THE WIRE GUIDE REMAINS IN THE PT, BUT THERE ARE PLANS TO REMOVE IT. DEVICE EXPIRATION DATE IS INDICATED AS INFINITE.
RUPTURE OF LEFT BREAST IMPLANT; SMOOTH TEXTURE.
PT HAD INITIAL SURGERY ON 12/20/95 ON HER RIGHT FOOT/ANKLE AND HAD A SUBTALAR AND TIBIOTALAR FUSION USING A RETROGRADE INTRAMEDULLARY NAIL TECHNIQUE. FIVE MONTHS POST-OP, THE INTRAMEDULLARY NAIL BROKE. ON 9/25/96 PT ELECTED TO UNDERGO SURGERY FOR REPLACEMENT OF THE BROKEN NAIL WITH A LARGER NAIL AND SUPPLEMENTAL LOCAL BONE GRAFT. PT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS.
ADMITTED FOR ELECTIVE AAA REPAIR. SURGERY UNEVENTFUL. THREE DAYS POST-OP, PT DEVELOPED RESPIRATORY PROBLEMS AND WAS PLACED ON VENTILATOR AT 6 PM ON 8/31. ON 9/1 AT 11:40 AM VENT FAILED AND WOULD NOT RESTART. "VENT INOP" ALARM WAS ONLY FUNCTION. PT MANUALLY VENTILATED & PLACED ON DIFFERENT VENTILATOR.
ON 4/16/96, ARRIVED TO FIND A 43 YEAR OLD FEMALE IN CARDIAC ARREST. CREW HOOKED UP UNIT AND GOT A "SERVICE MANDITORY" PROMPT. THEY POPPED BATTERY OUT AND PUT IT BACK IN AND UNIT STAYED IN "SERVICE MANDITORY" MODE. WHEN CHIEF ATTEMPTED TO DOWNLOAD MCM, THEY GOT "ERROR 5 NOT A CO DEVICE REPORT". PARAMEDICS ARRIVED ON SCENE AND TOOK OVER PT CARE. THEY WERE ABLE TO DELIVER A FEW SHOCKS BUT PT CONDITION STAYED THE SAME. THE PARAMEDICS TRANSPORTED THE PT TO A HOSP WHERE SHE WAS PRONOUNCED.
H6, CODE 100 EXPLANATION: THE EPROM WAS FOUND POPPED OUT OF ITS SOCKET. EVAL: THE REPORTED COMPLAINT OF "SVC MANDATORY" PROMPTS WAS VERIFIED. A SVC TECHNICIAN FOUND AN EPROM HAD POPPED FROM ITS SOCKET. THE EPROM WAS RESEATED AND PROPER OPERATION OF THE DEVICE WAS VERIFIED. NO OTHER ELECTRICAL OR MECHANICAL PROBLEMS WERE FOUND THAT WOULD HAVE CAUSED THE "SVC MANDATORY" PROMPTS. THE HS200 OPERATING INSTRUCTIONS MANUAL INSTRUCTS THE USER, IN THE EVENT OF A "SVC MANDATORY" PROMPT THAT WILL NOT CLEAR, TO DISCONTINUE USE, FOLLOW MEDICAL PROTOCOLS TO CONTINUE PT CARE, REMOVE DEVICE FROM USE, AND REQUEST REPAIR.
WHILE PHYSICIAN WAS TIGHTENING FIXATION POST IN RIGHT KNEE, THE FIXATION POST SNAPPED IN HALF. TOP HALF WAS REMOVED; THE REMAINING PORTION WAS LEFT IN THE PT.
ON 9/3/96, CO AND ANOTHER CO RECEIVED A LAWSUIT INVOLVING AN ALLEGED INJURY RESULTING FROM THE USE OF BLOOD GLUCOSE METER. THIS EVENT WAS ORIGINALLY REPORTED TO CO ON 10/3/94, HOWEVER, DUE TO THE ATTENUATED NATURE OF THE REPORTER'S ALLEGATION, NO MDR REPORT WAS FILED AT THAT TIME. THE PT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS ON 8/2/94. NO INFO IS AVAILABLE REGARDING THE PT'S HOSPITALIZATION. UPON DISCHARGE, THE PT WAS REFERED TO A NEUROLOGIST FOR COMPLAINT OF NUMBNESS, WEAKNESS AND INABILITY TO USE HIS RIGHT HAND. THE PHYSICIAN SUMMARIZES THE PT'S CONDITION AS "SEVERE DIABETIC PERIPHERAL NEUROPATHY WITH ATROPHY AND WEAKNESS OF THE HANDS AND FEET. HISTORICALLY THE RIGHT HAND SYMPTONMS APPEARED TO BE RECENT RELATED TO HIS HOSPITALIZATION." OTHER NOTATION INCLUDE "A SHUNT PLACED IN THE RIGHT ELBOW FOR DIALYSIS FOR MORE THAN A YEAR", "STASIS ULCERS IN HIS LEGS", "BILATERAL FOOT DRIP." THE METER WAS ALLEGED TO HAVE BEEN PURCHASED BY THE PT ON 8/2/94. COMPARISONS WERE PERFORMED BY AN OUTSIDE CONSULTANT, USING THE PT'S METER AND ANOTHER METER ON 7/24/96. THE RESULTS OF THE CAPILLARY TESTS (WHOLE BLOOD FROM A NON-DIABETIC INDIVIDUAL) ARE AS FOLLOWS: METER -91 AND 79 MG/DL; ANOTHER METER -85 AND 82 MG/DL. NO LABORATORY COMPARISONS WERE DONE.
CO HAS COMPLETE THE INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNK ANOMALY. AT THIS POINT, CO INVESTIGATION OF THIS MATTER IS CLOSED.
AT 11:40 A.M. THE VENTILATOR FAILED AND WOULD NOT RESET. "VENT INOP." ALARM WAS ONLY FUNCTIONAL. THE PT WAS MANUALLY VENTILATED AND PLACED ON DIFFERENT VENTILATOR.
CLOSE INSPECTION AN INTERMITTENT SHORT WAS NOTICED COMING FROM THE POWER TRANSISTOR SOCKETS AT TRANSISTOR 2N5886. HOSPITAL BIOMED, REPLACED THE TRANSISTOR SOCKET AND THE VENTILATOR OPERATED CORRECTLY.
INFO ON A MEDICAL DEVICE REGISTRATION FORM INDICATED THAT ATTEMPTS TO DEPLOY A CORONARY STENT WITH DELIVERY SYSTEM AT THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY WERE UNSUCCESSFUL. DURING THE WITHDRAWAL OF  THE DELIVERY SYSTEM, THE PHYSICIAN NOTED THAT THE STENT WAS MISSING FROM THE BALLOON CATHETER. THE PHYSICIAN WAS UNCERTAIN IF THE STENT HAD EMBOLIZED IN THE PT'S BODY OR WAS NOT PRESENT ON THE BALLOON CATHETER PRIOR TO USE. ATTEMPTS TO DEPLOY ANOTHER MFR'S STENT WERE UNSUCCESSFUL DUE TO CLOSING OF THE PT'S VESSEL. THE PT WAS SENT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS UNSUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
FRACTURE OF INSET PATELLA'S.U.H.M.W.P.E. PEG. THE PATELLA IS REPORTED TO HAVE BEEN IMPLANTED FOR APPROX ONE YEAR.
H3 EVALUATION SUMMARY: NON-DESTRUCTIVE VISUAL EVALUATION WAS PERFORMED ON THE 86-7021 PFC INSERT PATELLA. THE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE (I.E. POLYETHYLENE) PATELLA COMPONENT WAS RECEIVED AS TWO SEPARATE PIECES DUE TO FRACTURE OF THE CENTRAL FIXATION POST AT THE POST/DOME INTERFACE. THE ARTICULATING SURFACE OF THE PATELLAR COMPONENT SHOWED AREAS OF BURNISHING AND DEFORMATION WHERE IT ARTICULATED WITH THE FEMORAL COMPONENT. ORIGINAL MATCHING MARKS WERE VISIBLE OVER THE REST OF THE SURFACE. EXAMINATION OF THE ANTERIOR SIDE OF THE PATELLA COMPONENT SHOWED THAT THREE OF THE FOUR CEMENT POCKETS WERE FILLED WITH BONE CEMENT. FATIGUE-TYPE STRIATIONS WERE NOTED ON THE FRACTURE SURFACE. THE FRACTURED CENTRAL POST WAS RECEIVED SEPARATELY AND SHOWED SCRATCHING AND DEFORMATION TYPICAL OF REMOVAL AND HANDLING. IN SUMMARY, PATELLAR FAILURE OCCURRED BY FRACTURE OF THE CENTRAL POLYETHYLENE FIXATION POST AND THE BONE CEMENT INTERFACE BETWEEN THE COMPONENT AND THE PATELLAR BONE. NO APPARENT MATERIAL OR MFG DEFECTS WERE NOTED ON THE COMPONENT.
THE PT AWOKE ON 8/30 FEELING ILL WITH VOMITING AND NAUSEA. SHE TRIED TO DRINK WATER OR TEA THROUGHOUT THE DAY, BUT CONTINUED TO VOMIT. TWO BLOOD GLUCOSE TESTS SWERE PERFORMED ON THE PT'S METER AT 5/P WITH RESULTS OF 2.9 AND 3.6 MMOL/L. SHE WAS PRIVATELY TRANSPORTED TO A CLINIC WHERE A 6:30/P CLINIC METER (BRAND UNK) READING OF >32 MMOL/L WAS OBTAINED. THE PT WAS THEN TRANSPORTED TO THE HOSP WHERE SHE WAS ADMITTED FOR DIABETIC KETOACIDOSIS. SHE WAS TREATED WITH "4 INTRAVENOUS BAGS FOR DEHYDRATION" AND A "WHITE LIQUID" DRUG TO "COMBAT THE ACID FLOWING IN THE BODY." SHE WAS RELEASED ON 9/1. THE METER IS NOT CLEANED ACCORDING TO MFR'S RECOMMENDATIONS. THE TEST STRIP HOLDER IS CLEANED REFGULARLY, HOWEVER, THE METER OPTICS ARE NOT CLEANED. THE METER WAS IN CALIBRATION ON 9/4 READING 4.7 WITHIN A RANGE OF 4.3-5.8.
CO HAS COMPLETED INVESTIGATION OF THE MDER INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAS NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEAINING/MAINTENANCE, OR SOME UNKNOWN ANOMALY. AT THIS POINT INVESTIGATION OF THIS MATTER IS CLOSED.
DURING AN ATTEMPT TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LEIOSN SITE IN THE PT'S OBTUSE MARGINAL BRANCH, THE STENT SLIPPED OFF THE BALLOON CATHETER. THE BALLOON CATHETER WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION. A SNARE WIRE WAS USED TO SUCCESSFULLY RETRIEVE THE STENT. AN ADD'L CORONARY STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
300-SUBSTANCE NOTED INSIDE THE TOUHY-BORST AND SHEATH LUMEN OF THE DEVICE INDICATES ATTEMPTED BALLOON INFLATION. THIS CONTRADICTS THE COMPLAINANTS REPORT.
AN IV INFUSION OF 25,000 U OF HEPARIN IN 250CC OF D5W, THAT WAS ATTACHED TO CO IV PUMP, INFUSED INTO A PT IN APPROX. 3 HRS. THE PUMP SET TO INFUSE AT 8 ML/HR. ONE HR AFTER THE EVENT, THE PT SUFFERED A CARDIAC ARREST AND DIED. PRIOR TO THE ARREST, SHE HAD BEEN FOLLOWING COMMANDS. THERE IS A QUESTION THAT THE PT HAD EXTENDED A CEREBRAL BLEED AS A RESULT OF THE HEPARIN OVERINFUSION. THE PTT WAS GREATER THAN 180 SECONDS. PROTAMINE WAS GIVEN TO REVERSE THE HEPARIN. PT HAD BEEN BLEEDING FROM NG TUBE PRIOR TO THIS EVENT.
PIECE OF PLASTIC FROM BALLOON CATHETER BROKE OFF AND WAS RETAINED IN PT'S VASCULAR SYSTEM DURING CARDIAC CATH.
THE PHYSICIAN ATTEMPTED TO PLACE THE IAB IN THE OR. HE WAS ABLE TO PLACE THE BALLOON, BUT DID NOT GET ANY WAVEFORM. HE WAS UNSUCCESSFUL IN FLUSHING THE IAB. WHEN X-RAY WAS TAKEN, THE TIP OF THE CAHETER APPEARED TO BE LOOPED. THE IAB WAS REMOVED AND REPLACED WITH ANOTHER IAB. THERE WERE NO PT COMPLICATIONS.
MFR CONTROL NO: DI96-214. THE SAMPLE WAS RETURNED FOR EVALUATION. THE IAB WAS VACUUM TESTED, AND ALSO TESTED ON A PUMP FOR 20 MINUTES, AND NO ALARMS WERE TRIGGERED. THE IAB WAS THEN TESTED AT VARIOUS HEART RATES AND NO PROBLEMS WERE ENCOUNTERED. THE CUSTOMER'S DIFFICULTY COULD NOT BE DUPLICATED.
TWO CORONARY STENTS WITH DELIVERY SYSTEM WERE SUCCESSFULLY DEPLOYED AT THE  TARGET LESION SITE IN THE PT'S SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY. APPROX SIX MONTHS SUBSEQUENT, RESTENOSIS OCCURRED AT THE STENTED AREA WHICH REQUIRED THE PLACEMENT OF A THIRD CORONARY STENT SYSTEM WITHIN THE STENT SITE. THE PROCEDURE WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED REALTIVE TO THE EVENT.
THE INFO WAS INITIALLY RECEIVED ON A CORONARY STENT TRAINING FORM ON 8/16/96. ADD'L INFO WAS OBTAINED DURING A TELEPHONE CONVERSATION WITH THE STENTING PHYSICIAN ON 9/13/96. THE PS1535 STENT WITH THE DELIVERY SYSTEM IS INDICATED FOR USE IN NATIVE CORONARY PROCEDURES ONLY. REFER TO MEDWATCH FORM 2247023-1996-00050 FOR A REPORT OF A SECOND STENT INVOLVED IN THIS CASE.
PT WAS SCHEDULED FOR A LAPAROSCOPIC BILATERAL TUBAL BANDING. AFTER DRAINAGE OF THE BLADDER A CLAMP WAS ATTEMPTED TO BE POSITIONED INTO THE INTRAUTERINE CAVITY. HOWEVER, EVEN WITH GENTLE PASSAGE OF THE CLAMP INTO THE ENDOCERVICAL CURETTAGE, THERE WAS MINIMAL RESISTANCE WITH FURTHER PASSAGE OF THE CLAMP AND A UTERINE PERFORATION WAS SUSPECTED. LAPAROSCOPY CONFIRMED THAT THE CLAMP WAS PENETRATING THROUGH A SMALL PERFORATION IN THE ANTERIOR ASPECT OF THE UTERUS NEAR THE LOWER UTERINE SEGMENT AROUND THE LEVEL OF THE PT'S PRIOR C-SECTION. A CYSTOSCOPY CONFIRMED NO BLADDER TRAUMA AND THE INTRAUTERINE CAVITY WITH DIRECT VISION BY LAPAROSCOPY.
THE INFO WAS INITIALLY RECEIVED ON A CORONARY STENT TRAINING FORM ON 8/16/96. ADD'L INFO WAS OBTAINED DURING A TELEPHONE CONVERSATION WITH THE STENTING PHYSICIAN ON 9/13/96. THIS STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN NATIVE CORONARY PROCEDURES ONLY. REFER TO MEDWATCH FORM 2247023-1996-00048 FOR A REPORT OF A SECOND STENT INVOLVED IN THIS CASE.
PT IN FOR D&C. DIAGNOSTIC LAPAROSCOPY FOR ANEMIA, ABD. PAIN, UTERINE BLEEDING. PT ANESTHESIZED, INTUBATED AND PLACED IN KNEE STIRRUPS. D&C PERFORMED. #10 TROCAR THEN INTRODUCED INTO ABD. BLOOD BEGAN TO POUR INTO ABD. IMMEDIATELY OPENED, REQUESTED ASSISTANCE OF VASCULAR SURGEON, HEART TEAM CALLED FOR REPAIR OF AORTA AND VENA CAVA. PT RECOVERED.
LOW PRESSURE ALARM REMAINED ON. PT TAKEN OFF VENTILATOR AND AMBUED THEN PLACED ON ANOTHER VENTILATOR. NO PT HARM.
LEAKING LEFT BREAST IMPLANT. IMPLANT WAS SURGICALLY REMOVED.
THE MD APPLIED THE SMALL FIXATOR FOR A FEMORAL LENGTHENING. IT WAS SUBSEQUENTLY NOTED THAT THE SERRATED JOINTS ON THE FIXATOR HAD LOOSENED. A SECOND SURGERY WAS PERFORMED TO REPLACE THE FIXATOR.
THE UNIT WAS INSPECTED BY THE USER FACILITY AND NO PROBLEM FOUND. USER FACILITY PERFORMED CHECK-OUT PROCEDURE WITHOUT ANY PROBLEMS.
BILATERAL CAPSULAR CONTRACTURE. CAPSULECTOMY WITH REMOVAL AND EXCHANGE OF IMPLANT.
A REVISION HAS BEEN PERFORMED ON A PT WHO UNDERWENT A TOTAL KNEE REPLACEMENT IN 1991.
A 61-YR-OLD FEMALE HAD A THROMBOSED CATHETER WHICH REQUIRED REPLACEMENT DUE TO EXTREME DIFFICULTIES IN OBTAINING A VENOUS ACCESS. CATHETER ORIGINALLY PLACED 3/95. PT HAD REPLACEMENT PROCEDURE ON 9/24/96.
REOPERATION PERFORMED ON 10/2/96 ON ELDERLY FEMALE PT DUE TO SPINAL IMPLANTS BECOMING LOOSE, POSSIBLY DUE TO TECHNIQUE USED DURING IMPLANTATION. IMPLANTS ORIGINALLY IMPLANTED ON 7/3/96: L3-5 ON LEFT SIDE, L4-5 ON RIGHT SIDE. ALL SPINE SYSTEM IMPLANTS REMOVED. SURGEON IMPLANTED ANOTHER GRAFT AND DIFFERENT HARDWARE. NO IMPLICATIONS REPORTED.
FROM SECTION D-6: SCREWS: 3-SW530T (LOT#LT85JGI), 2-SW535T (LOT#LT07AH1); RODS: 1-SW400T (LOT#LT03IG7/IG), 1-SW410T (LOT#LT06KG7); NUTS: 5-SW001T (LOT#S 1 OF LT21KGI, 1 OF LT20KGI, 3 OF LT07DGI). DEVICE EVALUATION STILL INCOMPLETE AS OF 10/9/96: PRELIMINARY RESULTS INDICATE NO CROSS-THREADING OF NUTS/SCREWS EVIDENT.
EVAL RESULTS SUGGEST THAT THIS EVENT IS PT RELATED. THE PT SUFFERED AN ADVERSE REACTION TO THE PRODUCT. THIS ADVERSE REACTION IS WELL KNOWN AND DOCUMENTED WITHIN THE PRODUCT LITERATURE.
PT HAD RIGHT SALINE IMPLANT REMOVED DUE TO LEAKING. PHYSICIAN NOTED A SMALL HOLE IN POSTERIOR ASPECT OF IMPLANT. PT REQUIRED A CAPSULECTOMY.
WHEN THERAPIST WENT TO CHANGE PT BACK TO VENT, NOTICED WHAT APPEARED TO BE A 2ND INNER CANNULA INSIDE THE DISPOSABLE INNER CANNULA. UPON CLOSER EXAMINATION, THE CANNULA HAD SEPARATED ITSELF FROM THE CLIPS AND WAS PROTRUDING OUT.
A STONE REMOVAL WAS PERFORMED WITH A HARD WIRE BASKET. DURING THE PROCEDURE THE PHYSICIAN CAPTURED THE STONE AND ATTEMPTED REMOVAL, HOWEVER, THE STONE WAS HINDERED BY ITS SIZE. SUBSEQUENTLY, THE STONE BECAME IMPACTED INTO THE BASKET. THE DRIVE WIRE WAS CUT AND REMOVED WITH THE ENDOSCOPE, WHILE THE DISTAL PORTION OF THE DEVICE REMAINED IN THE PT. THE PT WAS TAKEN TO SURGERY WHERE THE STONE AD BASKET WERE REMOVED SUCCESSFULLY.
THIS REPORT IS BASED ENTIRELY ON UNCONFIRMED INFO SUBMITTED BY OTHERS. NEITHER SUBMISSION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENDED TO BE AN ADMISSION THAT ANY CO DEVICE (I) IS DEFECTIVE OR MALFUNCTIONED OR (II) CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. CO DOES NOT BELIEVE THAT THIS REPORTED INCIDENT IS LIKELY TO REOCCUR. THE DISTAL PORTION OF THE DEVICE AND A 2.3CM STONE WERE RECEIVED. THE REMAINDER OF THE BASKET WAS NOT INCLUDED (HANDLE, DRIVE WIRE AND SHEATH). CONCLUSIONS: THE HOSP'S RISK MGR STATED SHE FELT THERE WAS NO MALFUNCTION OF THE DEVICE ITSELF, BUT RATHER IT WAS THE SIZE OF THE STONE THAT PROHIBITED NORMAL REMOVAL OF THE STONE FROM THE BILE DUCT. CORRECTIVE ACTION: THE CAUTIONS OF THE INSTRUCTIONS STATE AN ASSESSMENT OF THE STONE AND THE AMPULLARY ORIFICE MAY NECESSITATE A SPHINCTEROTOMY. IT IS STATED UNDER THE PRECAUTIONS FOR STONE EXTRACTIONS, THAT IF THE PASSAGE IS RESTRICTED SURGICAL INTERVENTION MAY BE REQUIRED TO REMOVE THE STONE.
S/P AUGMENTATION IN 1989. SINCE THAT TIME THERE WERE CHANGES IN SHAPE, SIZE, AND CONSISTENCY, ESPECIALLY IN LAST YEAR. GRADE II CONTRACTURE BILATERALLY WITH IRREGULAR SHAPE R BREAST. PT HAD BILATERAL IMPLANT REMOVAL WITH TOTAL CAPSULECTOMY AND AUGMENTATION.
THIS REPORT WAS RECEIVED FROM A PHYSICIAN OF A PT WHO UNDERWENT CATARACT EXTRACTION AND IMPLANTATION OF AN IOL. ONE WEEK AFTER IMPLANTATION, THE IOL WAS FOUND TO BE DISLOCATED AND THE LOOP WAS DEFORMED. SECONDARY SURGERY WAS REQUIRED TO REMOVE THE LENS. NO COMPLICATIONS WERE REPORTED. FURTHER INFO IS EXPECTED. EVALUATION OF THE LENS IS PENDING. THIS LENS IS NOT MARKETED IN THE UNITED STATES AND IS THE SAME AS THE DEVICE EXCEPT FOR THE HEPARIN SURFACE MODIFICATION.
FAILED HIP SCREW WITH CUTOUT OF LAG SCREW THROUGH FEMORAL HEAD AND ACETABULUM.
DURING CORONARY ARTERY STENT PLACEMENT BY CARDIOLOGIST, THE STENT WAS MALDEPLOYED. THE STENT WAS UNABLE TO BE RETRIEVED WITH A SNARE AND THE PT HAD TO UNDERGO A TWO VESSEL REVASCULARIZATION TO RETRIEVE THE DEVICE.
PT BURNED UNDER ECG ELECTRODES WHILE UNDERGOING MRI SCAN. ONE THIRD-DEGREE BURN, TWO SECOND-DEGREE BRUNS, AND ONE FIRST-DEGREE BURN. APPROX ONE WEEK LATER, A 2ND PT RECEIVED TWO SECOND-DEGREE BURNS UNDER SIMILAR CONDITIONS.
A BALLOON DETACHED FROM THE CATHETER SHAFT DURING A CARDIAC CATHETERIZATION PROCEDURE. FURTHER FOLLOW UP INDICATED A SEVEN FRENCH BALLOON CATHETER WAS USED DURING A RIGHT HEART CATHETERIZATION FOR THE PURPOSE OF MEASURING RIGHT ATRIAL, RIGHT VENTRICLE AND PULMONARY ARTERY PRESSURES. UPON WITHDRAWAL OF THE SEVEN FRENCH BALLOON CATHETER, IT WAS NOTED THE BALLOON MATERIAL WAS MISSING. THE PT SUBSEQUENTLY RETURNED TO THE HOSP POST-DISCHARGE AND WAS DIAGNOSED AT THAT TIME WITH PULMONARY EMBOLISM. A LEFT HEART ANGIOGRAM WAS ALSO PERFORMED AT THE TIME OF THE RIGHT HEART CATHETERIZATION, HOWEVER, SINCE THIS PROCEDURE IS PERFORMED IN THE ARTERIAL SYSTEM, DETACHMENT OF BALLOON MATERIAL COULD NOT RESULT IN A PULMONARY EMBOLISM. CONFUSION REGARDING THE DEVICE USED FOR THIS PROCEDURE AND/OR THE EXACT USAGE OF THIS PRODUCT REMAINS. THE OCCLUSION BALLOON CATHETER REFERENCED IN THIS MEDWATCH IS AN EIGHT FRENCH BALLOON CATHETER AND IS CONTRAINDICATED IN THE DIRECTIONS FOR USE FOR USE AS A VASCULAR FLOW-DIRECTED CATHETER (SWAN-GANZ TYPE USED TO MEASURE RIGHT HEART PRESSURES). FURTHER FOLLOW UP DID NOT CLARIFY THE EXACT USAGE OF THE EIGHT FRENCH BALLOON CATHETER REFERENCED IN THIS MEDWATCH OR WHETHER IT WAS INVOLVED WITH THE REPORTED PULMONARY EMBOLISM. CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: "OCCLUSION BALLOON CATHETERS ARE NOT DESIGNED FOR USE AS VASCULAR FLOW-DIRECTED CATHETERS CARE SHOULD BE EXERCISED WHEN BOTH INTRODUCING AND REMOVING BALLOONS TO AVOID PUTTING UNDUE STRESS WHICH MIGHT RUPTURE A BALLOON CATHETER JUNCTION.
THE CAUSE OF DEATH IS LISTED ON THE EXPLANT REPORT AS "ARRHYTHMIC/SUDDEN/UNWITNESSED REFRACTORY VF". PROGRAMMER PRINTOUTS AND STORED ELECTROGRAMS ARE INCLUDED WITH THE INFO. OF NOTE IS THE LAST HIGH VOLTAGE LEAD IMPEDANCE OF >200 OHMS. IN ADDITION, THE STORED ELECTORGRAMS SHOWED A SHORTER THAN EXPECTED SHOCK TO SHOCK TIME. THIS WOULD SEEM TO INDICATE A LEAD PROBLEM. HOWEVER, SINCE THE ENTIRE LEADS WERE NOT RETURNED WITH THE DEVICE, A DEVICE PROBLEM CANNOT BE ABSOLUTELY RULED OUT.
THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLEY BY CO. E4. & F. USER FACILITY. F2, 4 & 5. SEVERAL ATTEMPTS TO OBTAIN THIS INFO WAS UNSUCCESSFUL. TO DATE THE HSP HAS NOT PROVIDED CO WITH THE INFO.
SECTIONS A-F ARE REPLICATED FROM A MEDWATCH FORM RECEIVED ON 9/13/96. THE ADD'L INFO PROVIDED BELOW WAS OBTAINED DURING A TELEPHONE CONVERSATION WITH THE RISK MANAGER, ON 9/16/96. RISK MANAGER, HOWEVER, COULD NOT IDENTIFY WHICH ONE OF THE THREE STENTS LISTED IN SECTION D6 WAS MALDEPLOYED. ATTEMPTS TO DEPLOY ONE OF THREE CORONARY STENTS WITH DELIVERY SYSTEM AT A TARGET LESION SITE WERE UNSUCCESSFUL. ATTEMPTS TO RETRIEVE THE STENT USING A SNARE WERE UNSUCCESSFUL. THE PT WAS SENT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESFUL AND THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. DEVICE CODE:1158 AND PT CODE:2357.
DURING AN ATTEMPTED ABDOMINAL AND SMALL MESENTERIC ANGIOGRAM, APPROX 13 CM FRAGMENT OF THE GUIDEWIRE LEFT IN RIGHT GROIN AT RIGHT FEMORAL ARTERY. SURGICALLY REMOVED THE FOREIGN BODY AT RIGHT GROIN.
WITHOUT THE SAMPLLE FOR EVALUATION OR THE PRODUCT CODE OR THE LOT NUMBER FOR THE DEVICE, IT IS DIFFICULT FOR CO TO CONDUCT AN EVALUATION ON THIS OCCURRENCE. THE MFG FACTORY HAS BEEN INFORMED OF THIS OCCURRENCE. AS A CAUTION, IT IS INDICATED ON CO'S PACKAGE LABELING "TO AVOID DAMAGE AND POSSIBLE SHEARING OF (THE) PLASTIC, DO NOT WITHDRAW OR MANIPULATE THROUGH A METAL CANNULA/METAL DILATOR NOR ADVANCE THE METAL CANNULA/METAL DILATROR. EXTREME CAUTION SHOULD BE OBSERVED WHEN USED WITH A ONE-WALL PUNCTURE STYLE NEEDLE."
ON 9/5/96 THE PT UNDERWENT PROCTECTOMY AND RESECTION OF RECTAL TUMOR. DURING THE PROCEDURE A 7MM FLAT DRAIN WAS PLACED. 9/9/96 THE PT WAS BEING PREPARED FOR DISCHARGE. THE PHYSICIAN REMOVED THE DRAIN SUTURES, SUCTION WAS TAKEN OFF BULB AND TRACTION WAS PLACED ON DRAIN TO PULL IT OUT. PT EXPERIENCED A "PRESSURE" FEELING. WHILE ATTEMPTING CO TO REMOVE PLASTIC PORTION OF THE DRAIN, A SMALL PORTION OF THE DRAIN WAS RETAINED IN THE PT. ATTEMPTS TO REMOVE THE RETAINED PORTION VIA FLUOROSCOPY WAS UNSUCCESSFUL. THEREFORE, THE PT WAS TAKEN TO THE OPERATING ROOM AND UNDER GENERAL ANESTHESIA, THE RETAINED PORTION OF THE DRAIN WAS REMOVED FROM THE PERI-RECTAL SPACE. POST-OPERATIVELY, THE PT DID WELL AS WAS DISCHARGED HOME ON 9/11/96.
POTENTIAL PROBLEM IDENTIFIED W/PUMP TUBING, POSSIBLY DUE TO PACKAGING PROCESS WHICH DAMAGED DISC. CONCERN RELATES TO PROBLEM WHEN USING DAMAGED SETS WHICH REQUIRE CLAMPING & REMOVING PUMP SET IN ORDER TO REMEDY THE ALARM - CONSTANT ALARMS "DISC ALARM". POTENTIAL TO ANY PEDS PT ON VASOACTIVE MEDICATIONS. COULD RECEIVE BOLUS. SOME PTS CANNOT TOLERATE STOPPING OF INFUSION WHICH RESULTS IN HYPOTENSION. PER MFR THE CHECK DISC ALARMS WERE CAUSED BY WARPED SENSOR DISCS IN THE IV SET. THE WARPING IS ISOLATED TO SPECIFIC PRODUCT LOTS THAT WERE EXPOSED TO EXCESSIVE TEMP. THE PROBLEM WAS IDENTIFIED BY CO'S QUALITY ENGINEERING STAFF.
ON 9/24/96, PT PRESENTED TO THE ED WITH COMPLAINT OF HEMOPTYSIS SINCE 9/23. THE PT UNDERWENT A VQ SCAN WHICH WAS WITHIN NORMAL LIMITS. PT ALSO HAD AN ECHOCARDIOGRAM WHICH REVEALED A GOOD EJECTION FRACTION OF THE LEFT VENTRICLE. IT ALSO REVEALED A CATHETER FRAGMENT IN THE RIGHT ATRIUM. THE PT REPORTED SHE HAD A CENTRAL LINE INSERTED IN 11/95, AFTER A SURGICAL PROCEDURE FOR BOWEL OBSTRUCTION. THE FOREIGN BODY WAS REMOVED FROM THE RIGHT ATRIUM VIA ANGIOGRAPHY. PT DISCHARGED 9/26/96 IN GOOD CONDITION.
THE PT UNDERWENT PROCTECTOMY AND RESECTION OF RECTAL TUMOR. DURING THE PROCEDURE 7 MM DRAIN PLACED. 9/9/96 THE PT WAS BEING PREPARED FOR DISCHARGE. THE PHYSICIAN REMOVED THE DRAIN SUTURES, SUCTION WAS TAKEN OFF BULB AND TRACTION WAS PLACED ON THE DRAIN TO PULL IT OUT. PT EXPERIENCED A "PRESSURE" FEELING. WHILE ATTEMPTING TO REMOVE PLASTIC PORTION OF THE DRAIN. A SMALL PORTION OF DRAIN WAS RETAINED IN THE PT. ATTEMPTS TO REMOVE THE RETAINED THE DRAIN PORTION WAS REMOVED FROM THE PERI-RECTAL SPACE. POST OPERATIVELY, THE PT DID WELL AND WAS DISCHARGED HOME ON 9/11/96.
NO PHYSICIAL SAMPLE WAS REC'D FROM THE ACCOUNT. PAST HISTORY OF COMPLAINTS OF COMPLAINTS OF THIS TYPE HAVE BEEN DUE TO NICKING, SUTURING AND TISSUE INGROWTH OF THE DRAIN.
ON 9/8, THE PT, AN IDDM, AWOKE AT 4/A VOMITING. NO BLOOD GLUCOSE TEST WAS PERFORMED AT THIS TIME, SHE "SETTLED DOWN AND WENT BACK TO SLEEP." SHE AWOKE AGAIN AT 6/A, VOMITING AND AT 8:30/A, A BLOOD GLUCOSE RESULT OF 109 MG/DL WAS OBTAINED ON THE PT'S METER USING TEST STRIPS LOT # G20204, EXP 5/96. SHE WAS GIVEN HER NORMAL DOSE OF INSULIN (20U NPH, 8U R) AT 11:30/A, HOWEVER, SHE ONLY CONSUMED WATER. SHE WAS TAKEN TO THE ER AT 2/P WHERE A HOSP METER (BRAND UNK) BG READING OF 460 MG/DL WAS OBTAINED (THE PT'S METER AND STRIPS READ "5" AT THE SAME TIME). SHE WAS TREATED WITH INSULIN AND IV AND LATER (4/P) WAS ADMITTED TO A MEDICAL CTR FOR TREATMENT OF DIABETIC KETOACIDOSIS. THE METER IS CLEANED ACCORDING TO MFR'S RECOMMENDATIONS. HOWEVER, IT IS NOT CLEANED ONCE A WEEK AS IS SUGGESTED IN THE OWNER'S MANUAL. CALIBRATION STATUS IS UNK AT THIS TIME.
REPORT REC'D ALLEGING MEDICAL ATTENTION WAS REQUIRED AFTER EXPERIENCING AN INSERTER INJURY.
510K #950928. 1 PERSON SERIOUS INJURY TYPE G.
A BLADDER NECK SUSPENSION PROCEDURE WAS PERFORMED WITHOUT INCIDENT ON AN OBESE PT. EIGHT DAYS POST-OPERATIVE, THE PT DEVELOPED A FEVER. A DIAGNOSIS OF STREP B WAS CONFIRMED. THE INCISION WAS DRAINED AND THE PT WAS PLACED ON ANTIBIOTICS. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. CO'S FOLLOW UP INDICATED A POSSIBLE NOSOCOMIAL STAPHYLOCCAL INFECTION, WHICH MAY HAVE BEEN CONTRIBUTING FACTOR TO THIS EVENT. CO DOES NOT ATTRIBUTE NOSOCOMIAL INFECTION TO THE DEVICE. HOWEVER, WITHOUT FURTHER INFO, CO IS UNABLE TO DETERMINE THE EXACT FOR THIS EVENT.
VALVE WAS EXPLANTED. NO OTHER INFO IS AVAILABLE AT THIS TIME.
VALVE WAS RECEIVED IN ST. JUDE MEDICAL DIV FER ANALYSIS LAB IN A ST. JUDE MEDICAL PRODUCT RETURN KIT, SUBMERGED IN A LIQUID SOLUTION. SEWING CUFF WAS BROWN IN COLOR AND CONTAINED ONE LONG, BLACK SUTURE WHICH EXTENDED FROM CUFF SEVERAL CENTIMETERS. WHITE TISSUE WAS ALSO OBSERVED ON SEWING CUFF, EXTENDING UP ONTO INFLOW RIM. SEWING CUFF WAS CUT IN SEVERAL PLACES, AS WELL. CARBON SURFACES WERE COVERED WITH A GRANULAR SUBSTANCE APPEARING TO BE DRIED BLOOD. VALVE WAS THEN CHEMICALLY STERILIZED AND FORWARDED TO DR., AN INDEPENDENT PATHOLOGIT FOR EVAL. DR STATED IN HIS REPORT WHITE TISSUE OBSERVED ON SEWING CUFF WAS THIN FIBROUS TISSUE OF A NORMAL HEALING REACTION WHICH EXTENDED ONTO, BUT NOT INTO, ANNULAR HOUSING OF VALVE. BOTH LEAFLETS MOVED FREELY AND COMPLETELY. NO INFLAMMATION OR ORGANISMS WERE IDENTIFIED. A SMALL FOCUS OF APPARENTLY ORGAINIZING THROMBUS WAS DETECTED IN ONE OTHER SITE. VALVE WAS THEN CLEANED, AND SEWING CUFF WAS REMOVED. VALVE WAS THEN VISUALLY EXAMINED AT 10X MAGNIFICATION FOR ANY ANOMALIES ON SURFACES OF LEAFLETS AND ORIFICE. LEAFLETS AND ORIFICE WERE FOUND TO BE UNREMARKABLE. VALVE WAS DISASSEMBLED FOR PERFORMANCING TESTING. RESULTS OF PULSE DUPICATOR TESTING INDICATED VALVE HAD NO ABNORMAL OPERATION. FLOW AND PRESSURE TRACES INDICATED VELAVE OPERATED SATIFACTORILY WITHOUT LEAFLET OR HYDRODYNAMIC MALFUNCTIONS. FUNCTIONAL LEAKAGE TESING WAS PERFORMED, AND VALVE MET ALL ST. JUDE MEDICAL'S SPECIFICATIONS. LEAFLET AND ORIFICE DIMENSIONS WERE INSPECTED AND VERIFIED TO BE WITHIN ST. JUDE MEDICAL'S SPECIFICATIONS. VALVE'S DEVICE HISTORY RECORD WAS EXAMINED TO ENDURE THAT EACH MFG AND INSPECTION OPERATION WAS FOLLOWED BY APPROPRIATE SIGNATURE AND DATE, INDICATING THAT PROCESS WAS PERFORMED IN ACCORDANCE WITH ST. JUDE MEDICAL'S SPECIFICATIONS. EACH OPERATION FOR MFG AND INSPECTION OF THIS VALVE WAS FOLLOWED BY APPROPRIATE SIGNATURE AND DATE. INFO REVIEWED FROM VALVE'S HISTORY RECORD AND ADD'L TESTING PERFORMED THROUGH FER ANALYSIS LAB INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH ST. JUDE MEDICAL SPECIFICATIONS AT TIME OF MANUFACTURE. RESULTS OF THIS INVESTIGATION INDICATED VALVE WAS EXPLANTED UDE TO THROMBUS FORMATION ON VALVE, WHICH CAUSED AN ELEVATED GRADIENT AND AORTIC STENOSIS. THIS VALVE WAS NOT EXPLANTED DUE TO AN INTRINSIC VALVE DEFECT. TESTING PERFORMED AT ST. JUDE MEDICAL DIV AND OBSERVATINS MADE BY DR., HOSPITAL'S PATHOLOGY DEPT, AND DR. INDICATED VALVE FUNCTIONED NORMALLY.
PT WITH HISTORY OF PELVIC RADIATION EXPERIENCED BOWEL PERFORATION WITH COLONOSCOPY FOR RECTAL BLEED. PT UNDERWENT AN EXPLORATORY LAPAROTOMY, SUBTOTAL COLECTOMY WITH ILEOSTOMY. NO PROBLEM WITH DEVICE; PT'S UNDERLYING ANATOMY PREDISPOSED HER TO THIS EVENT.
THE VENTILATOR WAS CONNECTED TO A PT. THE CUSTOMER REPORTS THAT THE VENTILATOR WAS IN THE SIMV MODE WITH A TRIGGER SENSITIVITY OF-2 AND A PEEP OF 2 WHEN THE VENTILATOR'S PEEP LEVEL ROSE TO 20 CM H20. AT THIS TIME IT IS UNKNOWN IF THE VENTILATOR CAUSED ANY PT INJURY. THE UPPER PRESSURE ALARM ACTIVATED. THERE ARE NO OTHER VENTILATOR SETTINGS AVAILABLE.
THE VENTILATOR WAS EVALUATED BY CO. THREE PROBLEMS WERE FOUND WHICH ANY ONE OF THE THREE COULD HAS CAUSED THE REPORTED PROBLEM. 1) THE PC765 BOARD WAS FOUND TO HAVE AN UNSTABLE TRIM POT. 2) THE HOLDER FOR THE EXP. PRESSURE FILTER WAS MISSING. 3) A ORDINARY STAPLE WAS FOUND SITTING ON THE INTERFACE BOARD 766. THE VENTILATOR WAS REPAIRED AND PERFORMED WITHIN SPECS.
DESPITE CO'S ATTEMPTS TO OBTAIN INFO (SERIAL NUMBER, COMPLETE MODEL#) ON THE SPECIFIC DEVICE INVOLVED IN THIS EVENT, CO IS UNABLE TO POSITIVELY IDENTIFY THE SUSPECT DEVICE. THE FACILITY OWNS MANY TYPES & MODELS OF CO'S VIDEO COLONSCOPES AND THEY COULD NOT IDENTIFY THE SPECIFIC DEVICE INVOLVED. THE USER FACILILTY STATES THE DEVICE WAS NOT AT FAULT AND THE PT'S ANATOMY PREDISPOSED HER TO THIS EVENT. BASED UPON THIS AND THE FACT THAT THE FACILITY CONTINUES TO USE THE EQUIPMENT, CO CONCURS WITH THE USER FACILITY THAT THIS IS A USUAL, KNOWN RISK FOR THIS TYPE OF MEDICAL PROCEDURE.
INCIDENTS OF PT REACTIONS DURING TREATMENT. THE PTS COMPLAINED OF FEVER, MUSCLE AND JOINT PAIN, CONJUNCTIVITIS AND DEAFNESS. NO OTHER INFO IS AVAILABLE.
AN ANALYSIS WAS PERFORMED BY THE MFR ON A COMPANION SAMPLE FOR THE LEVEL OF CELLULOSE ACETATE OLIGOMER. CO PERFORMED AN EVALUATION ON A COMPANION SAMPLE FROM THE SAME LOT. THE LEVEL OF CELLULOSE ACETATE OLIGOMER (CAO) IN THE COMPANION SAMPLE WAS FOUND TO BE WELL WITHIN THE MFR'S SPECIFICATION.
A BLADDER NECK SUSPENSION PROCEDURE WAS PERFORMED WITHOUT INCIDENT ON 4/25/96. ON 6/5/, THE PT RETURNED AND HAD DEVELOPED A DELAYED SUPRAPUBIC INFECTION WHICH WAS OPENED AND DRAINED. A KUB PERFORMED IN JUNE REVEALED SOME FROM DISPLACEMENT OF THE LEFT ANCHOR. THE PT REMAINED CONTINENT AND NO TREATMENT WAS ADMINISTERED AT THAT TIME. THE PT SUBSEQUENTLY DEVELOPED OSTEOLYELITIS OF THE SYMPHYSIS PUBIS WITH ABSCESS IN THE RIGHT ADDUCTOR REGION. BOTH BONE ANCHORS WERE SURGICALLY REMOVED. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. OSTEOMYELITIS OF THE SYMPHYSIS PUBIS OCCURS MOST OFTEN AS A SECONDARY INFECTION FROM AN ADJACENT FOCUS (AFTER SURGERY). IT MAY ALSO RESULT FROM HEMATOGENOUS SPREAD FROM BACTEREMIA. FOLLOW UP REVEALED THIS PT WAS A DIABETIC AND HAS A CHRONIC CONDITION, SYSTEMIC LUPUS ERYTHEMATOSUS. RISK FACTORS SUCH AS OBESITY, DIABETES, AND IMMUNOCOMPROMISED PTS CAN FURTHER PREDISPOSE THE PUBIS TO INFECTION. "SURGICAL TRAUMA AND IMPAIRED VASCULAR CIRCULATION CAN INJURE THE PERIOSTEAL INTEGRITY OF THE SYMPHYSIS PUBIS AND LEAVE THE BONE SUSCEPTIBLE TO INFECTION. ANY LOCAL INFECTION, WOUND INFECTION OR ABSCESS COULD THEN SECONDARILY INFECT THE BONE."1. "OSTEOMYELITIS OF THE PUBIS: COMPLICATION OF A STAMEY URETHROPEXY," THE JOURNAL OF UROLOGY, VOL 151 (JUNE 1994), PP 1638-1640.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO AIR LOCK IN PUMP.
9/4/96 RIGHT FRONTAL CRANEOTOMY AND CLIPPING OF ANEURYSM. 9/5/96 POST-OP ANGIO, SLIPPED CLIP. PT RETURNED TO OR 9/6/96 FOR REPEAT CLIPPING. NEUROSURGEON UNABLE TO DETERMINE IF CLIP IS DEFECTIVE OR PRESSURE CAUSED CLIP TO SLIP.
BOTH PORT SEPTAS WERE FLUSHED WITHOUT DIFFICULTY. THE PROXIMAL LUMEN LEAKED AT TWO SITES NEAR THE CATH-LOCK. ONE OF THE LEAK SITES WAS SIMILAR AND APPERARED GLOSSY AND SMOOTH, WHICH IS TYPICAL OF A CUT FROM A SHARP INSTRUMENT. THE OTHER LEAK SITE APPEARED JAGGED AND FRACTURED WITH EVIDENCE OF COMPRESSION. THIS TYPE OF DAMAGE CAN OCCUR FROM THE USE OR A SMOOTH JAWED CLAMPING DEVICE, OR A PUNCTURE FROM A SUTURE NEEDLE.
LACERATION OF THE SMALL BOWEL MESENTERY OCCURRED ALLEGEDLY DURING INSERTION OF TROCAR FOR LAPAROSCOPIC PROCEDURE. EXPLORATORY LAPAROTOMY WITH REPAIR OF MESENTERIC ARTERY AND MULTIPLE BLOOD TRANSFUSIONS REQUIRED TO TREAT VESSEL INJURY. PT DISCHARGED ON THE SIXTH POST-OP DAY WITHOUT FURTHER COMPLICATIONS. QUESTION REGARDING APPROPRIATE FUNCTIONING OF PLASTIC SHIELD ON DEVICE. UNFORTUNATELY EQUIPMENT WAS NOT SAVED.
THE PT WAS IMPLANTED WITH A SALINE ON 3/26/93. SUBSEQUENTLY THE DR NOTED THAT THE DEVICE HAD DEFLATED. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. CO EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSABLE IN TO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO. IS THE FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES" IS EVENT OF GREATER SEVERITY THAN STATED IS LABELING? N. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (MENTOR EFFECTIVE DATE, 2/10/92). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILLING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21CFR803.
THE PT, A 65 YR OLD, TYPE 1 DIABETIC, REPORTED HIGHER BLOOD GLUCOSE READINGS WITH TEST STRIP. HE DOES NOT KNOWN WHEN HE OPENED THE BOTTLE WHICH HE PURCHASED APPROX 2 MONTHS AGO. UPON INITIAL OPENING, THE PT DID NOT NOTICE A DIFFERENCE IN HIS READINGS. APPROX 2 TO 3 WEEKS AFTER OPENING THE BOTTLE, THE PT ADMINISTERED HIS USUAL MORNING INSULIN DOSAGE OF 20 NPH. HE DOES NOT REMEMBER WHETHER HE TOOK HIS BLOOD GLUCOSE THAT MORNING. AT APPROX 12:00 PM THE SAME DAY, THE PT OBTAINED A READING IN THE 400 MG/DL RANGE. ALTHOUGH HE GENERALLY DOES NOT TAKE AN INJECTION IN THE AFTERNOON, HE ADMINISTERED APPROX 15 UNITS OF REGULAR INSULIN. AT APPROX 2 PM, THE PT WAS DRIVING AND PULLED OVER TO THE SIDE OF THE ROAD BECAUSE HE WAS EXPERIENCING SEVERE HYPOGLYCEMIC SYMPTOMS (IE LACK OF CONCENTRATION, TIREDNESS). AT APPROX 4: PM , A HIGHWAY PATROL OFFICER FOUND THE PT PASSED OUT IN HIS CAR SO HE CALLED 911. WHEN THE PARAMEDICS ARRIVED, THEY TOOK THE PT'S BLOOD GLUCOSE WITH THEIR METER (TYPE UNKNOWN) AND OBTAINED A RESULT OF 20 MG/DL. THEY TRANSPORTED THE PT TO THE NEAREST EMERGENCY ROOM. AT THE E.R. A VENOUS BLOOD GLUCOSE SAMPLE WAS TAKEN, BUT THE PT DOES NOT KNOW THE RESULT. THEY ALSO ADMINISTERED A GLUCOSE I.V. THE PT WAS THEN TRANSPORTED TO A HOSP CLOSER TO HIS HOME AND WAS ADMITTED TO GET HIS "BLOOD SUGARS IN CONTROL". HE WAS RELEASED 1 1/2 MONTHS LATER. AFTER DISCHARGE, THE PT PERFORMED A SIDE BY SIDE BY SIDE BLOOD GLUCOSE COMPARISON WITH CO STRIP AND ANOTHER BRAND THE TEST STRIPS (LOT UNKNOWN) AND OBTAINED READINGS OF 189 MG/DL AND 114 MG/DL RESPECTIVELY. THE PT THEN CALLED TO REPORT THE HIGHER READINGS WITH CO STRIP AND THE METER MFR REP SENT THE PT A NEW METER. HE COULD NOT PERFORM A CHECK STRIP TEST ON THE FIRST METER WITH THE CO REP BECAUSE HE SENT IT TO ANOTHER MFR. THE PT DOES NOT HAVE NORMAL CONTROL SOLUTION AVAILABLE. HE DID NOT PERFORM A NORMAL CONTROL SOLUTION TEST OR A CHECK STRIP TEST DURING THE TIME PERIOD REFERENCED IN THE COMPLAINT. THE TEST STRIPS WERE STORED PROPERLY IN HIS BEDROOM. THE DESICCANT IS IN THE BOTTLE. HIS METER WAS SET TO THE APPROPRIATE CODE.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 9/24/96. ONE UNOPENED BOTTLE CONTAINING 25 STRIPS WITH DESICCANT WAS RETURNED TO CO FOR EVAL. THE TEST RESULT OF THE RETURNED BOTTLE MET THE SPECS FOR BLOOD GLUCOSE ACCURACY AND PRECISON AND DID NOT CONFIRM THE COMPLAINT OF HIGH BLOOD GLUCOSE READINGS. ERROR GRID ANALYSIS INDICATES THAT CUSTOMER'S TEST STRIPS MAY PRODUCE RESULTS WHICH FALL IN ZONE B AND DO NOT REPRESENT A REASONABLE RISK OF SERIOUS INJURY. CUSTOMER DID NOT PERFORM NORMAL CONTROL SOLUTION TO TEST THE STRIPS FOR ACCURACY. CUSTOMER DID NOT RUN COMPARISON WITH AN ACCEPTABLE REFERENCE METHOD. PRODUCT SHOULD NOT BE COMPARED TO OTHER TEST STRIPS WHICH THEMSELVES MAY BE INACCURATE. THE RETENTION SAMPLE TEST RESULTS FOR LOT 16050A MEET THE SPECS FOR THE BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE PRESENT EVAL, THE PROBABILITY THAT THIS WAS A PRODUCT MALFUNCTION IS LOW AND THAT IT IS UNLIKELY TO RECUR. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO.
PT SUSTAINED BURN LIKE LESION AT RIGHT CORNER OF MOUTH EXTENDING APPROX ONE (1) CM INTO CHEEK AREA. THOUGHT TO BE FROM CAUTERY UNIT.
ON 8/8 PT HAD PLACEMENT OF STENT FOR KIDNEY AND BLADDER STONES. ON 8/14 PT TO OFFICE C/O PAIN DUE TO MIGRATING STENT. ON 8/23 PT READMITTED TO HOSP FOR CYSTOSCOPY, BALLOON DILATION AND EXTRACTION OF STENT. STENT MIGRATED FROM RIGHT URETER TO RIGHT URETER AT ORIFICE. STENT WAS NOT REPLACED. THE URETER APPEARED TO BE WELL INTACT WITH MINIMAL MUCOSAL DISRUPTION.
THE DEVICE WAS REMOVED DUE TO AN "ANEURYSM." ONE OF THE CYLINDER BLADDER(S) WAS AFFECTED; ONLY ONE CYLINDER WAS REMOVED AND REPLACED.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 1/18/95 AND REVISED ON 9/6/96 DUE TO AN "ANEURYSM" IN ONE CYLINDER. THE MD STATED THAT "A BUBBLE FORMED IN IMPLANT CAUSING THE PT DISCOMFORT." REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENT REVEALED AN ANEURYSM PROXIMAL TO THE BASE. NO FURTHER ABNORMALITIES WERE DETECTED. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, AND BECAUSE THIS DEVICE IS CAPABLE OF GENERATING PRESSURE SUFFICIENT TO ANEURYZE AN UNRESTRICTED BLADDER, QA CONCLUDED THAT THE OBSERVED ANEURYSM OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. HOWEVER, BECAUSE NO INFO WAS PROVIDED AS TO WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS OCCURRENCE, QA PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED EVENT.
PT FAILED WEANING FROM BYPASS THREE TIMES. IAB INSERTED TRANSTHORACALLY AT 9PM. AN INSERTION ATTEMPT WAS MADE TO CLEAR CENTRAL LUMEN AND WAS UNSUCCESSFUL. IAB WAS REMOVED AND DISPOSED OF. REINSERTION OF IAB NO. SHEATH AT WAS USED EITHER TIME. AT 12AM BLOOD WAS SEEN IN THE LUMEN. DR MADE DECISION TO LEAVE IAB IN PLACE. PT EXPIRED ON 9/4/96 DUE TO ILLNESS.
H-11-ALL UNK INFO REQUESTED BUT NOT REC. H-11-SECTION  F PROVIDED BY MFR. H-11-SECTION F10 DEVICE CODE 1746 LABEL. INTERNAL#061996090011.
TWO SURGEONS RECEIVED 3RD DEGREE BURNS ON THEIR HAND DURING A SINGLE MONO-ELECTROSURGICAL LAPAROSCOPIC PROCEDURE. THE ELECTRODE WHICH HAS NO IDENTIFYING NUMBER OR NAME HAS AN UNUSUALLY LONG POST WHICH SCREWS INTO THE ELECTRODE. IT WAS LOOSE. ALSO THE INSULATED CONNECTOR WHICH FITS OVER THE POST WAS TOO SHORT TO COVER POST. THE SURGEONS RECEIVED BURNS BECAUSE THEIR HANDS TOUCHED THE EXPOSED METAL OF THE POST.
ADD'L INFO: IN SPITE OF EXTENSIVE RESEARCH DONE TO DATE, CO HAS NOT BEEN ABLE TO ESTABLISH CAUSALITY FOR THE TYPE OF EVENT REPORTED. FOR BUSINESS REASONS, CO HAS DECIDED TO DISCONTINUE THE DISTRIBUTION OF THIS CATHETER. HOWEVER, CO WILL CONTINUE TO TRACK THIS TYPE OF INFO, AS IT IS CRITICAL TO CO'S PRODUCT IMPROVEMENT AND DEVELOPMENT PROCESS.
WHILE ATTEMPTING TO REMOVE A BLOOD CULTURE BOTTLE FROM INSTRUMENT, THE  BOTTLE BROKE. THIS RESULTED IN A CUT TO THE TECHNOLOGIST'S RIGHT INDEX FINGER, REQUIRING MEDICAL INTERVNTION. (TETANUS SHOT AND 2 STITCHES). FREQUENCY OF OCCURRENCE STATEMENT (21 CFR 803.24(C)(7). THE PACKAGE INSERT AND INSTRUMENT OPERATOR'S MANUAL CONTAIN PRECAUTIONS CONCERNING POTENTIAL FOR GLASS BREAKAGE AND PRECAUTIONS FOR HANDLING POTENTIALLY INFECTIOUS BODY FLUIDS. EXPECTED FREQUENCY OF CUTS RESULTING FROM BREAKAGE OF THE GLASS BOTTLE ARE NOT SPECIFICALLY ADDRESSED IN THE PRODUCT LABELING. CO BELIEVES THAT THE FREQUENCY AT THE TIME OF THIS REPORT IS NOT GREATER THAN IS USUAL FOR THE DEVICE. SEVERITY OF OCCURRENCE STATEMENT (21 CFR 803.24(C)(7). THE PACKAGE INSERT AND INSTRUMENT OPERATOR'S MANUAL CONTAIN PRECAUTIONS CONCERNING POTENTIAL FOR GLASS BREAKAGE AND PRECAUTIONS FOR HANDLING POTENTIALLY INFECTIOUS BODY FLUIDS. THE DEGREE OF SEVERITY OF CUTS RESULTING FROM GLASS BOTTLE BREAKAGE IS NOT SPECIFCALLY ADDRESSED IN THE PRODUCT LABELING. CO BELIEVES THE DEGREE OF SEVERITY OF THIS INCIDENT IS NOT GREATER THAN WOULD BE EXPECTED FOR THE DEVICE.
THE DEVICE WAS SUCCESSFULLY INSERTED ON THE SECOND ATTEMPT. THEN THE PT COMPLAINED OF FEELING WARM AND BECAME DIAPHORETIC AND PALE AND LOSS CONSCIOUSNESS. PT WAS PUT ON THE FLOOR TO MAINTAIN AN OPEN AIRWAY AND STAFF CALLED 911. THE RN CHECKED THE PT'S PULSE AND RESPIRATION AND THEY WERE NOT PRESENT. RN REMOVED CATHETER WHEN PT LOSS CONSCIOUSNESS AND PROCEEDED TO INITIATE CPR PROTOCOL. THE PT SELF REVIVED BEFORE COMPRESSIONS OR BREATHS WERE GIVEN. HE TOOK TWO BREATHS AND STATED, "I FEEL BETTER NOW." THE PT WAS RESPONDING APPROPRIATELY AND WAS TRANSPORTED TO THE HOSPITAL WHERE ANOTHER SIMILAR DEVICE WAS SUCCESSFULLY PLACED AND THE PT WAS DISCHARGED HOME. THE PHYSICIAN STATED, "THIS WAS A VASO VAGAL RESPONSE."
CO HAS DECIDED TO DISCONTINUE MFR AND SALE OF THIS AND TWO BRANDS OF I.V. CATHETERS AS OD 9/18/96.
PT WAS FOUND FACE DOWN IN CUSHIONS OF DEVICE. PT HAD EXPIRED DUE TO SUFFOCATION.
AT THE TIME OF THIS REPORT, CO IS WAITING FOR PT INFO AND DEVICE EVALUATION INFO. THIS INFO WILL BE FORWARDED IN A FOLLOW-UP TO THIS REPORT.
A RENTAL SVC BIOMEDICAL TECH WAS PERFORMING THE PRE-DELIVERY INSPECTION ON A 3100A VENTILATOR AND THE % INSPIRATORY TIME DISPLAY READING WAS OUT OF SPEC. IT READ LOW - 24% AND HIGH = 44%. THE SPEC IS LOW = 28 TO 31% AND HIGH = 48 TO 52%. THERE WAS NO PT INVOLVEMENT AT ALL.
IS FREQUENCY ADDRESSED IN LABELING? NO. IF "YES" - FREQUENCY GREATER THAN LABELING? IF "NO" - FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "YES" - SEVERITY GREATER THAN LABELED? IF "NO" - SEVERITY GREATER THAN USUAL? UNK. THE UNIT WAS RETURNED TO THE FACTORY FOR SERVICING AND THE ANALYSIS HAS BEEN COMPLETED. TEST METHOD: THE UNIT WAS VISUALLY INSPECTED FOR DEFECTS. IT WAS ALSO TESTED PER THE PRODUCTION TEST PROCEDURE 767140 AND THE RENTAL TEST/INSPECTION PROCEDURE IP-767996. ANALYSIS: INITIAL VISUAL INSPECTION SHOWED NO PROBLEMS. AFTER FLEXING THE WIRING FROM THE INSPIRATORY PANEL METER, IT WAS OBSERVED THAT THE WIRING HAD BECOME LOOSE. THIS WAS A RESULT OF COLD SOLDER JOINTS ENABLING THE WIRES TO MAKE INTERMITTENT ELECTRICAL CONTRACT WITH THE PANEL METER PRINTED CIRCUIT BOARD. CONCLUSION: THE COMPLAINT WAS VERIFIED. THE POOR SOLDER JOINT LIFTED INTERMITTENTLY WITH VIBRATION OF THE OSCILLATOR CAUSING THE % INSP. RANGE TO SHIFT DOWN FROM ITS NORMAL RANGE OF 30 TO 50. CORRECTIVE ACTION: THE SOLDER JOINTS ON THE % INSP PANEL METER WERE TOUCHED UP. THE UNIT PASSED BOTH THE PRODUCTION TEST PROCEDURE AND THE RENTAL TEST/INSPECTION PROCEDURE AND WAS RETURNED TO THE RENTAL POOL. CO'S QA IS TRENDING COMPLAINTS AND WILL IMPLEMENT CORRECTIVE ACTION AS REQUIRED.
PT WAS 9 MONTHS POST OP WHEN SURGEON REVISED DUE TO BROKEN SCREW IN THE SACRUM.
FRACTURE SURFACE APPEARS TO HAVE BEEN CREATED BY FATIGUE FRACTURE CAUSED BY EXCESSIVE STRESS.
AN ABUTMENT SCREW HAS FRACTURED INSIDE AN IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
PT INFECTED BY MULTIRESISTANT P.AERUGINOSA (PSA). PT DIED WITH ONGOING SEPSIS BUT BLOOD CULTURES WERE NEGATIVE. ABSTRACT ATTACHED.
SUTURE WAS USED TO CLOSE FASCIA DURING A CESAREAN DELIVERY. AN ABDOMINAL EVISCERATION WAS DIAGNOSEED ON POST-OPERATIVE DAY SEVEN. UPON RE-EXPLORATION, SUTURE ALLEGED TO HAVE FAILED. INTERNAL CONTROL NUMBER IS: 9600653-00. REF FDA ACCESS #4001436.
THE ICD WAS INTERROGATED. NIPS WAS SELECTED; THE ICD CHARGED, DELIVERED A SHOCK, AND THEN A POPPING SOUND WAS HEARD. THE ICD WAS REINTERROGATED AND IT WAS NOTED THAT SHOCKING LEAD IMPEDANCES WERE OFF. THE PHYSICIAN SUSPECTED A PROBLEM WITH THE BT-10 LEAD OR A BREAK IN THE CO LEAD INSULATION. AN X-RAY WAS PERFORMED AND SEEMED TO INDICATE A POSSIBLE LEAD BREAK. SURGERY WAS PERFORMED TO EXPOSE THE AND AN INSULATION BREAK WAS INDEED OBSERVED. THE LEAD WAS THEN CAPPED AND PATCH LEADS WERE IMPLANTED. THE ICD WAS EXPLANTED "IN CASE THERE WAS A SHORT CIRCUIT" AND RETURNED TO CO FOR EVALUATION.
THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY CO. UNABLE TO VERIFY BY PHONE IS USER FACILITY SENT REPORT TO FDA. CO MEASURED THE RESISTANCE OF THE OUTPUT CONNECTORS ON THE DEFIB SIDE AND NOTED AN ABNORMALLY LOW IMPEDANCE PATH WHICH INDICATES THAT THE OUTPUT STAGE OF THE ICD HAS BEEN DAMAGED. THE CAUSE OF THIS DAMAGE IS UNKNOWN. PROPER BRADYCARDIA PACING, ANTI-TACHYCARDIA PACING, AND SENSING FUNCTION WERE TESTED AND FUNCTION PROPERLY. VARIOUS GENERAL PARAMETERS INCLUDING BATTERY VOLTAGE, ELECTROGRAM STORAGE, AND TELEMETRY RESPONSES WERE ALSO TESTED AND PASSED WITHIN SECIFICATIONS.
THREE WEEKS FOLLOWING LIVER SURGERY, A PT DEVELOPED BLEEDING AT THE PORTAL VEIN. THE PT WAS RETURNED TO SURGERY. THE SURGEON FOUND WHAT APPEARED TO BE PRODUCT REMAINING FROM PREVIOUS SURGERY SITUATED ON THE PORTAL VEIN.
DATE SENT TO FDA: 10/11/96. INVESTIGATION SUMMARY: KNOWLEDGE OF THIS INCIDENT CAME ABOUT THROUGH AN INFORMAL INQUIRY POSED TO A SALES REP BY DR. REPEATED ATTEMPTS WERE MADE TO ACQUIRE MORE INFO AND REQUEST A SAMPLE OF THE RETAINED "LUMP". ON 10/08/97, INFO WAS PROVIDED THAT THE ORIGINAL "LUMP" DESCRIBED IN THE INCIDENT WAS DESTROYED AFTER REMOVAL WITHOUT FURTHER EXAMINATION. NO ATTEMPT WAS MADE BY THE HOSP OR SURGEON TO IDENTIFY THE ORIGIN OF THE REPORTED "LUMP". WITHOUT EXAMINATION (BY THE FACILITY OR BY THE MFR), CO IS UNABLE TO VERIFY THAT THE LUMP WAS THE PRODUCT IDENTIFIED BY THE COMPLAINANT. WITH NO SAMPLE, NO LOT NUMBER AND THE LIMITED INFO PROVIDED, CO WAS UNABLE TO COME TO ANY CONCLUSION WITH REGARD TO THIS EVENT, HOWEVER, A REVIEW OF THE INSERT FOR THE PRODUCT IDENTIFIED WAS CONDUCTED. ONE OF THE PRECAUTIONS INCLUDED IN THE INSERT EMPHASIZES USING ONLY AS MUCH ABSORBABLE HEMOSTAT AS IS NECESSARY TO ACHIEVE HEMOSTASIS AND REMOVING ANY EXCESS BEFORE SURGICAL CLOSURE IN ORDER TO FACILITATE ABSORPTION AND MINIMIZE THE POSSIBILITY OF FOREIGN BODY REACTION.
LEADS WERE REMOVED DUE TO "LEAD FRACTURE". DURING A REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE LEADS WERE CAPPED AND REPLACED WITH A BIPOLAR LEAD.
PT ADMITTED 4/94, A NEWLY DIAGNOSED AML. PT SURVIVED BUT INFECTED. ADMITTED 11/94, AML RELAPSE. HAD POSITIVE PSA CULTURES AND DIED 12/6/94. PT WOULD LIKELY HAVE DIED OF DISEASE, BUT INFECTION MAY HAVE HASTENED EVENT. ABSTRACT ATTACHED. DATE OF EVENT 4/94 - 12/94.
PORT WAS PLACED ON 6/21/96 FOR IV ACCESS FOR CHEMOTHERAPY AND LAB DRAW. ON 8/27/96 UNABLE TO ASPIRATE BLOOD FROM PORT. DIFFICUTLY INFUSING OR FLUSHING PORT. PT SENT FOR FLUOROSCOPIC EVALUATION; INCREASED POSITIVE FOR CATHETER FRACTURE.
PT WAS ON R/F TABLE. THE FLUORO TOWER WAS MOVED. PT'S LEFT MIDDLE FINGER WAS LACERATED AND BROKEN. THE REPORTED LOCATION OF THE PINCH POINT WAS BETWEEN THE CABLE TROUGH AND THE GEAR HOUSING.
THIS INCIDENT WAS CAUSED BY OPERATOR ERROR. THERE IS A WARNING IN THE OPERATOR'S GUIDE THAT STATES: WARNING: MAKE SURE PT'S HANDS ARE CLEAR OF TABLETOP EDGES WHEN POWER TOP VERTICAL TOWER OR BUCKY IS OPERATED. PINCH POINTS ARE PRESENT. FAILURE TO COMPLY MAY CAUSE LACERATION OF PT'S FINGERS. TO DATE, THE HOSP HAS NOT RELEASED THEIR INTERNAL INCIDENT REPORT INFO. THE PT'S HEAD WAS AT THE FOOT END OF THE TABLE. THE PT'S LEFT FINGER WAS INJURED. THE MOST LIKELY MANNER FOR AN THIS TYPE OF INJURY TO OCCUR IN THIS PT POSITION IS THAT THE PT HAD HER LEFT ARM OFF THE REAR OF THE TABLE TOP AND HAD HER FINGER PINCHED BETWEEN A GEAR HOUSING AND A CABLE TROUGH. THIS DESIGN OF THIS PORTION OF THE TABLE IS 25 YRS OLD. THOUSANDS OF TABLES OF THIS TYPE WERE PRODUCED WITH MOST STILL IN USE. THIS IS THE ONLY REPORTED INCIDENT OF THIS TYPE ON RECORD. THIS INCIDENT IS DEEMED AN ISOLATED INCIDENT OF OPERATOR ERROR. NO FURTHER ACTION ANTICIPATED.
THE AFFECTED 4-POSITION LINE CLAMP WAS NOT RETUNED FOR AN EVAL. THE CUSTOMER CHOSE NOT TO RETURN THE PARTS DESPITE AN ISSUED RGA. HOWEVER, THE NATURE OF THIS COMPLAINT IS VERY SIMILAR TO THOSE OF OTHER COMPLAINTS (0896037C3, 0796207C3, 0796157C3, 0796160C3, AND 0796180C3) WHICH INVESTIGATION SHOWED THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS IN THE PREVIOUS COMPLAINTS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITIONS. IT IS CONCLUDED THAT THIS COMPLAINT PROBLEM IS SIMILAR. THE ABOVE INFO INDICATES THAT THE BROKEN LINE CLAMP DESCRIBED IN THIS COMPLAINT WAS GENERATED BECAUSE OF MISUSE BY THE OPERATOR. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATION, ANALYSES, AND/OR CORRECTIVE ACTIIONS TAKEN REVIEW PROCESS. SEE FAR # 960027. CUSTOMER CONTACTED: NO. SALES/SVC CONTACTED BY INVESTIGATOR? N. TRAINING REQURIED? NO.
CO HAS DECIDED TO DISCONTINUE MFR AND SALE OF THIS AND TWO OTHER BRANDS OF I.V. CATHETERS AS OF 9/18/96.
PT HAD TOTAL ABDOMINAL HYSTERECTOMY, PELVIC LAPAROTOMY AND BILATERAL SALPINGOOPHORECTOMY ON 8/22/96. ON 8/28 THE DRAIN WAS REMOVED. A PORTION OF THE DRAIN BROKE OFF, REQUIRING A RETURN TO SURGERY FOR EXPLORATION AND REMOVAL ON 8/28. RISK MANAGEMENT BECAME AWARE OF THIS EVENT ON 9/3/96. PORTION OF DRAIN TO BE RETURNED TO CO UPON RECEIPT OF PACKAGING INSTRUCTIONS AND FED EX # FROM CO .
THE LEAD WAS EXPLANTED DUE TO A REPORT OF NON-SPECIFIC FAILURE.
DURING REMOVAL OF A 14 GAUGE 2 1/2 INCH CATHETER IN THE LEFT ANTECUBITAL VEIN, THE CATHETER BROKE OFF AND MAJORITY OF THE CATHETER REMAINED IN THE PT'S VEIN. THE PT REQUIRED SURGICAL INTERVENTION TO REMOVE RETAINED CATHETER.
ON 9/26/96, THE MFR RECEIVED MEDWATCH REPORT #10 FROM THE FACILITY WHICH STATED THE FOLLOWING: THE DEVICE WAS IMPLANTED ON 6/21/96, FOR INTRAVENOUS (IV) ACCESS FOR CHEMOTHERAPY AND LAB DRAW. IN 7/96, THE PT DEVELOPED A POST-OPERATIVE INFECTION AND WAS TREATED WITH ANTIBIOTICS. ON 8/27/96, THE FACILITY WAS UNABLE TO ASPIRATE BLOOD FROM THE DEVICE. THE PT WAS SENT FOR FLUOROSCOPIC EVALUATION (8/27/96) WHICH REVEALED A POSITIVE FRACTURE IN THE DEVICE LINE WHERE IT ENTERS THE SUBCLAVIAN VEIN.
ON 9/26/96, A MFR REPRESENTATIVE CONTACTED THE FACILITY NURSE TO INQUIRE ABOUT RETURN OF THE DEVICE FOR ANALYSIS. THE FACILITY NURSE STATED THAT PER HOSP POLICY, THE PRODUCT WOULD NOT BE RELEASED TO THE MFR FOR ANALYSIS; HOWEVER, A MFR REPRESENTATIVE MAY GO TO THE FACILITY TO REVIEW THE PRODUCT. SINCE THE DEVICE IS NOT AVAILABLE FOR ANALYSIS, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG/LOT NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE MFR'S INVESTIGATION OF THIS INCIDENT IS INCONCLUSIVE. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
DATE SENT TO FDA: 10/11/96. EVAL OF THE RETURNED SAMPLE SUGGESTS THAT THE PRODUCT WAS BEING USED IN A MANNER OR SITUATION WHICH WAS INAPPROPRIATE GIVEN THE PRODUCT'S INTENDED FUNCTION OR PERFORMANCE LIMITATIONS. VISUAL INSPECTION OF THE SAMPLES AS WELL AS PHOTOGRAPHIC EXAMINATION (AT THE BROKEN AREAS) INDICATES THAT THE DRAIN MAY HAVE BEEN NICKED DURING THE OPERATION BY A SHARP EDGED INSTRUMENT. PRECAUTIONS INCLUDED IN THE PRODUCT INSERT STATE: "THE SILICONE ELASTOMER SUCTION DRAIN TUBING IS SOFT AND PLIABLE. IT SHOULD NOT BE HANDLED WITH POINTED, TOOTHED, SHARP CORNERED OR EVEN BLUNT INSTRUMENTS, AS PUNCTURES, SURFACE CUTS, NICKS, CRUSHING OR OTHER OVERSTRESSING CAN LEAD TO TEARING OR WARPING OF THE TUBING AND TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN AND/OR FRAGMENT RETENTION WITHIN THE WOUND. DO NOT SUTURE THROUGH OR CUT INTO THE DRAIN AS THIS MAY RESULT IN DRAIN BREAKAGE AND OR FRAGMENT RETENTION WITHIN THE WOUND". THE PRODUCT SAMPLE PROVIDED MAY HAVE BEEN SUBJECTED TO POINTED, TOOTHED, SHARP CORNERED OR BLUNT INSTRUMENTS. OVERSTRESSING OF THE TUBING CAN LEAD TO TEARING OR WARPING AS INDICATED IN THE INSERT PRECAUTIONS. DATA ANALYSIS INDICATES THAT COMPLAINTS OF THIS TYPE ARE NOT SIGNIFICANT RELATIVE TO THE VOLUME OF DRAINS SOLD, HOWEVER, TRENDS WILL CONTINUE TO BE MONITORED. NO FURTHER INVESTIGATION WILL BE CONDUCTED UNLESS WARRANTED BY AN UNEXPECTED AND SIGNIFICANT INCREASE IN COMPLAINTS.
PT UNCONSCIOUS; EMS FOUND IN V-FIB, CARDIOVERTED TO SLOW ESCAPE RHYTHM. PM COULD NOT BE INTERROGATED/PROGRAMMED. TEMPORARY PM/LEAD PLACED AND EVENTUALLY LOST CAPTURE, RENAL FUNCTION DETERIORATED, PT SUBSEQUENTLY EXPIRED.
BLOCK A5. EXTENDED EVENT DESCRIPTION-THE PACER IMPLANT DURATION PERIOD WAS 64 MONTHS. THE PUBLISHED PROJECTED LONGEVITY FOR THE DEVICE WAS 46 MONTHS. BLOCK H3: DEVICE EVALUATION SUMMARY-THE PACER WAS RECEIVED IN A NO OUTPUT CONDITION DUE TO A LOSS OF HERMETICITY. DISCLAIMER: THE SUBMISSION OF INFO BY TELECTRONICS PACING SYSTEMS PURSUANT TO MEDICAL DEVICE REPORTING (MDR) REGULATIONS DOES NOT CONSTITUTE AN ADMISSION THAT TELECTRONICS PACING SYSTEMS BELIEVES THAT THE DEVICE DESCRIBED ABOVE HAS MALFUNCTIONED OR THAT THERE EXISTS ANY CAUSAL CINNCETION BETWEEN THE DEVUCE AND A DEATH OR SERIOUS INJURY. ANY FREQUENCY DETERMINATION MADE BY TELECTRONICS PACING SYSTEMS FOR MDR SUBMISSION IS MADE ON AN INTRA-MODEL BASIS AND DOES NOT REFLECT ANY FUTURE FREQUENCY ANALYSIS MADE ON A INTER-MODEL COMPONENT LEVEL BASIS. USER REPORT ENCLOSED WITHOUT UF/DIST REPORT#.
IMPLANTS WERE EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION.
86 =DIMENSIONAL ANALYSIS. 100 =THE RETURNED COMPONENT SHOWED THAT TISSUE WAS PRESENT. THE RETURNED COMPONENT MET CO'S REMAINING VISUAL AND DIMENSIONAL SPECIFICATIONS.
DATE SENT TO FDA: 10/11/96. CLARIFICATION FOR SECTION H6 EVALUATION CODE. METHOD 86: OPTICAL EVALUATION OF THE POINT OF SEVERANCE. THE FACILITY RETURNED THE USED PRODUCT WHICH REMAINED ATTACHED TO AN INTERMITTENT INJECTION CAP OF UNK BRAND FOR EVAL. MICROSCOPY AND VISUAL EXAM REVEALED THE FOLLOWING: CATHETER TUBING, MEASURING APPROX 5/32" REMAINED ATTACHED TO THE HUB. THE UNATTACHED SEGMENT MEASURED APPROX 2 1/8". THE TUBING AT THE POINT OF SEVERANCE APPEARS JAGGED, INDICATING THAT THE TUBING HAD SUSTAINED NUMEROUS PERFORATIONS WITH A SHARP, TAPERED OBJECT SUCH AS AN IV NEEDLE. A LARGE PROTRUSION OF A PORTION OF THE TUBING AT THIS POINT INDICATES THAT TENSION HAD BEEN APPLIED AS WELL. AFTER REVEIWING THE SAMPLE DATA, IT HAS BEEN DETERMINED THAT THE SEVERANCE OCCURRED AS A DIRECT RESULT OF EMPLOYMENT OF IMPROPER PROCEDURES BY THE DEVICE USERS. ANY IV CATHETER WILL BECOME SEVERED WHEN IMPROPER PROCEDURES ARE EMPLOYED. PACKAGE INSTRUCTIONS WHICH ACCOMPANY THE PRODUCT ADVISE CUSTOMER AGAINST REINSERTING THE INTRODUCER NEEDLE, AS DOING SO WILL PUNCTURE THE TUBING AND MAY RESULT IN A CATHETER EMBOLUS. THE CUSTOMER WILL BE ADVISED OF CO'S FINDINGS, AND PROPER INSERTION AND MAINTENANCE PROCEDURES WILL BE REVIEWED.
PT REQUIRED SURGERY FOR MALIGNANT SQUAMOUS CELL CARCINOMA OF THE RIGHT MANDIBLE. THREE MONTHS POST-OPERATIVELY THE SURGEON ORDERED X-RAYS WHICH SHOWED THE PLATE BROKEN. THE PT HAD NO SYMPTOMS OR SIGNS OF A BROKEN PLATE.
THIS EVENT IS NOT OCCURRING MORE FREQUENTLY NOR WITH GREATER SEVERITY THAN IS TYPICAL FOR THIS TYPE OF DEVICE. SINCE PRODUCT INTRODUCTION IN 1995 THE RATE OF REPORTED BROKEN PLATES PER US UNIT SALES IS .05% FOR THIS FAMILY OF HOWMEDICA LEIBINGER PRODUCT.
PT ADMITTED 6/17/94 IN ALL RELAPSE. HAD POSITIVE PSA BLOOD CULTURES. PT WOULD PROBABLY HAVE DIED FROM THE DISEASE, BUT THE INFECTION MAY HAVE HASTENED THE EVENT. ABSTRACT ATTCHED. DATE OF EVENT 6/17/94 - 9/4/94.
HOSP PERSONNEL ATTENDED TO A PT IN A CODE SITUATION. ALLEGEDLY WHEN DEFIBRILLATION THERAPY WAS ATTEMPTED, THE DEFIBRILLATOR WOULD NOT CHARGE. THE PT WAS IMMEDIATELY TRANSPORTED TO THE CORONARY CARE UNIT AND TREATMENT WAS CONTINUED. THE PT WAS RESUSCITATED.
CO TESTED THE UNITS AND FOUND THEM TO OPERATE NORMALLY DURING PERFORMANCE AND FUNCTIONAL TESTING. DURING TESTING, THE DEFIBRILLATOR CABLE CONNECTOR OF THE SHOCK ADVISORY SYSTEM ADAPTER WAS FOUND TO HAVE DEPRESSION MARKS AS IF HARD PADDLES HAD BEEN FORCE FITTED THERE. AFTER FURTHER INQUIRY THE REPORTER INDICATED THE OPERATOR WAS A FIRST TIME USER OF THIS EQUIPMENT AND WAS UNFAMILIAR WITH IT. CO PROVIDED ADD'L TRAINING TO THE FACILITY. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
PT ADMITTED 6/24/94, NEWLY DIAGNOSED AML. POSITIVE PSA CULTURE 9/94. PT INFECTED BUT SURVIVED. THIS PT WAS IDENTIFIED WHEN SEARCHING THE DATABASE FOR PTS WITH VERY RESISTANT PSA WHO WERE ON THE IDENTIFIED NURSING UNIT. ABSTRACT ATTACHED. DATE OF EVENT 6/24/94 - 10/19/94.
THE DEVICE WAS IMPLANTED ON 9/10/96 FOR SUBCLAVIAN INFUSION OF DRUG. ON 9/13/96, THE PT CONTACTED A MFR NURSE AND STATED THAT THERE HAS BEEN LITTLE BLOOD RETURN FROM THE DEVICE SINCE IMPLANT. THE PT STATED THAT THE PHYSICIAN TOLD HER THAT THE DEVICE CATHETER TIP IS "WAY DOWN IN THR RIGHT ATRIUM" AND THE DEVICE IS IMPLANTED "LOW INTO THE BREAST TISSUE." THE PT THEN STATED THAT THIS IS HER FOURTH VASCULAR ACCESS DEVICE AND THE SECOND FROM THE MFR. SHE THEN INQUIRED WHAT SHE SHOULD DO NEXT. THE MFR NURSE RESTATED THE PT'S CONCERNS AND THE PT STATED THAT SHE MAY SEEK ANOTHER OPINION. THE MFR NURSE THEN STATED THAT AN X-RAY SHOULD BE PERFORMED TO VIEW THE POSITION OF THE DEVICE CATHETER TIP TO DETERMINE WHY BLOOD RETURN IS NOT OCCURRING. THE PT ALSO STATED THAT SHE HAD EXPERIENCED HEART "CONTRACTIONS" DURING INFUSION. THE PT THEN STATED THAT SHE WOULD CONTACT THE MFR NURSE WITH A DECISION REGARDING THE DEVICE. ALSO ON 9/13/96, THE PT'S SPOUSE LEFT A MESSAGEE ON A MFR ENGINEER'S VOICE MAIL WHICH DETAILED THE PT'S HISTORY FOR THE PAST SEVERAL YEARS. THE SPOUSE REPORTED THAT THE PT HAS HAD TWO OF THE MFR'S DEVICES IMPLANTED BY THE SAME SURGEON FOUR MONTHS APART AND THAT IN BOTH CASES, THEY EXPERIENCED DIFFICULTY OBTAINING A BLOOD RETURN. THE PT'S SPOUSE THEN REQUESTED ANY INFO THE MFR MAY HAVE CONCERNING WHY THIS WOULD OCCUR AND ALSO ASKED IF THE MFR HAD ANY INFO CONCERNING AN ALTERNATE DEVICE WHICH COULD BE USED FOR HIS WIFE'S THERAPY.
ON 10/11/96, THE MFR CONTACTED THE PATIENT TO OBTAIN FOLLOW UP INFO. THE PATIENT REPORTED THAT SHE HAD SPOKEN WITH A FACILITY NURSE WHO HAD SUGGESTED THE PROCEDURE BE DONE BY "CUTDOWN" BECAUSE THE PATIENT HAS A PARALYZED DIAPHRAGM AND THORACIC OUTLET SYNDROME. THE PATIENT THEN STATED THAT SHE SOUGHT A SECOND OPINION CONCERNING THE DEVICE FROM ANOTHER PHYSICIAN WHO LOOKED AT THE O.R. X-RAYS AND THOSE DONE A WEEK LATER AND SAW DEVICE CATHETER "PINCH-OFF" SYNDROME. THE DEVICE WAS EXPLANTED ON 9/19/96 AND DISCARDED. THE PHYSICIAN STATED THAT THERE WAS "NOTHING WRONG" WITH THE DEVICE. THE PATIENT ALSO REPORTED THAT SHE HAD ANOTHER MFR'S DEVICE IMPLANTED AND HER NEW PHYSICIAN WAS UNABLE TO PLACE THE DEVICE CATHETER TIP IN THE SUPERIOR VENA CAVA BECAUSE OF AN "ENORMOUS BLOOD CLOT". THE PATIENT REPORTED THAT SHE HAS FILED A SUIT AGAINST THE FIRST PHYSICIAN AND DOES NOT IN ANY WAY FEEL THAT THE MFR'S DEVICE WAS AT FAULT. SINCE THE DEVICE HAS BEEN DISCARDED AND A LOT NUMBER WAS NOT PROVIDED, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS ON THIS CATALOG NUMBER. A TREND ANALYSIS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CATALOG NUMBER DID NOT IDENTIFY ANY TRENDS. BASED ON THE AVAILABLE INFO, AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
THE STAPLER WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE SURGEON OPENED THE DEVICE, REPLACED THE BLUE CARTIRDGE WITH A EVU35 AND FIRED ACROSS THE MESOAPPENDIX. AFTER FIRING, SURGEON COULD NOT OPEN THE INSTRUMENT'S JAWS. AFTER SEVERAL MINS THE JAWS WERE PRYED OPEN. A NEW EZ35 WAS OPENED TO COMPLETE THE CASE. THE SURGEON DRY FIRED THE INSTURMENT AFTER THE CASE. REP IS RETURNING RELOAD EVU35, BATCH # EM0159. THERE WAS NO CONSEQUENCE TO THE PT.
CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT OPEN" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS OPENED AND CLOSED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
THE FACILITY CONTACT REPORTS THAT THE PT DEVELOPED ERYTHEMA AND PRURITIS AT THE IV DEVICE INSERTION SITE. THE SYMPTOMS WERE TREATED WITH IV DIPHENHYDRAMINE. THE SYMPTOMS SUBSIDED, AND THE DEVICE WAS LEFT IN PLACE.
A REQUEST WAS MADE FOR ADD'L INFO, BUT THE FACILITY CONTACT REPORTED THAT THE INFO COULD NOT BE OBTAINED. THE FACILITY DID NOT PROVIDE CO WITH ANY PRODUCT SAMPLE OR LOT NUMBER. LIMITED INFO WAS PROVIDED TO CO. THE FACILITY REPORTS THAT ERYTHEMA AND PRURITIS WAS EXPERIENCED BY THE PT AT THE SITE AFTER APPROX. ONE HR OF DEVICE DWELL TIME. THE SYMPTOMS WERE AMELIORATED BY THE ADMINISTRATION OF IV DIPHENHYDRAMINE. BASED ON THIS INFO IT IS DIFFICULT TO CONCLUSIVELY DETERMINE THE EXACT CAUSE OF THE SYMPTOMS. HOWEVER, THE SYMPTOMS ARE CONSISTENT WITH CONTACT DERMATITIS. CONTACT DERMATITIS CAN DEVELOP IN A CERTAIN PORTION OF THE ADULT POPULATION WHEN EXPOSED TO NICKEL. THE HUB OF THE CATHETER CONTAINS NICKEL. INSTRUCTIONS, WHICH ACCOMPANY EACH PRODUCT PACKAGE, ADVISE THE USER THAT THE DEVICE CONTAINS NICKEL IN THE HUB. THE INSTRUCTIONS ALSO RECOMMEND THAT, IN ORDER TO AVOID THE DEVELOPMENT OF CONTACT DERMATITIS, THE DEVICE BE TAPED IN SUCH A WAY THAT THE HUB DOES NOT HAVE DIRECT CONTACT WITH THE PT'S SKIN. THE FACILITY WILL BE ADVISED OF CO'S FINDINGS, AND THE PACKAGE INSTRUCTIONS WILL BE REVIEWED WITH THE FACILITY CONTACT. THE FACILITY WILL ALSO BE ADVISED TO INFORM THE PT THAT A NICKEL SENSITIVITY MAY EXIST.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. ACCORDING TO CLINICAN THREE IMPLANTS WERE PLACED IN SITES #22, # 25 AND #27 DURING A ROUTINE PROCEDURE USING FREEZE-DRIED BONE. THE CLINICIAN REPORTS THE IMPLANTS DID NOT INTEGRATE AND WERE REMOVED 2 MONTH POST-OPERATIVELY.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. THE MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS ENDOSSEOUS DENTAL IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
PRODUCT IS KNOWN TO CAUSE THE REPORTED SYMPTOMS IF ENDOSCOPES ARE NOT PROPERLY RINSED. REPORTED AS SERIOUS INJURY AS THERE WAS A REPORTED NEED OF HOSPITALIZATION ADN ANTIBIOTICS. CALLER WISHED TO REMAIN ANONYMOUS. PRODUCT CODE AND LOT NUMBER NOT KNOWN. CALLER STATES THAT SHE KNOWS SOMEONE WHO EXPERIENCED BLOODY DIARRHEA, CRAMPING, FEVER, AND SEPTIC SYMPTOMS WHICH STARTED 2 HOURS AFTER A COLONOSCOPY AND LASTED FOR 1 WEEK OCCURRING 3-4 YEARS AGO. ALL TESTS WERE NEGATIVE, NO PERFORATIONS, INFECTIONS, ETC. THEY GAVE HER ANTIBIOTIC TREATMENTS DURING HER HOSPITALIZATION. THE CALLER REQUESTED INFO REGARDING WHAT SYMPTOMS MIGHT OCCUR IF THE SCOPE HAD NOT HAD THE SOLUTION RINSED OFF PROPERLY PRIOR TO USE ON A PT.
DATE SENT TO FDA: 10/12/96. CALLER WISHES TO REMAIN ANONYMOUS. PAST MDR FILLINGS FOR THIS TYPE EVENT CHECKED IN FILES AND NO CORRELATION COULD BE DISCOVERED.
PT ADMITTED 10/24/94 WITH NEWLY DIAGNOSED AML. POSITIVE CULTURES FOR PAS. PT SURVIVED BUT WAS INFECTED. DATE OV EVENT 10/24/94 - 12/9/94. ABSTRACT ATTACHED.
CATHETER WAS INSERTED IN THE LEFT MID-FOREARM PER PROCEDURE WITHOUT DIFFICULTY. THE PT IMMEDIATELY EXPERIENCED A SEVERE REACTION COMPLAINING OF NAUSEA, HEADACHE, NUMBENESS OF FACE, SEVERE SHOULDER TO BACK PAIN, SHORTNESS OF BREATH AND DIZZINESS. BLOOD PRESSURE AT 240/120. THE CATHETER WAS REMOVED AND ALL SYMPTOMS SUBSIDED.
DATE SENT TO FDA: 10/11/96. CO HAS DECIDED TO DISCONTINUE MANUFACTURE AND SALE OF THIS AND TWO OTHER BRANDS OF IV CATHETERS AS OF 9/18/96.
CLINICIAN REPORTED LOSS OF INTEGRATION OF THREE ENDOSSEOUS DENTAL IMPLANTS. CO HAS ASKED FOR ADD'L INFO AND THE RETURN OF THE IMPLANTS BUT NOT YET RECEIVED THESE.
THE INFO RECEIVED BY THE MFR FROM THE CLINICIAN IS INCOMPLETE. HOWEVER, THE COMPANY'S EVALUATION OF THIS EVENT (BASED ON EXISTING INFO) GIVES THE COMPANY CAUSE TO CONCLUDE THAT THIS EVENT IS A KNOWN INHERENT RISK OF THE PROCEDURE. THE MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS ENDOSSEOUS DENTAL IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
PT WAS ADMITTED 10/18/94 AND DIED OF AML ON 11/30/94. HE HAD NEGATIVE BLOOD CULTURES BUT POSITIVE URINE AND CATHETER SITE CULTURES. DATE OF EVENT 10/18/94 - 11/30/94. ABSTACT ATTACHED.
THE REPORTING FACILITY STATES THAT THEY HAVE NOTED AN INCREASE IN IV THERAPY RELATED INFECTIONS SINCE BEGINNING TO USE THIS DEVICE. THE PERCEIVED INCREASE IN IV RELATED INFECTION RATES WAS REPORTEDLY ASSOCIATED WITH DEVICE SECUREMENT DIFFICULTIES. THE FACILITY CONTACT STATED THAT IT IS HER BELIEF THAT THE INCREASE MAY HAVE BEEN CAUSED BY A LEARNING CURVE WHICH WAS EXPERIENCED BY THE STAFF DURING THE RECENT CONVERSION TO THIS PRODUCT BY THE FACILITY. SHE REPORTED THAT THE INFECTION RATE BEGAN TO RESOLVE SPONTANEOUSLY AS THE STAFF OBTAINED GREATER EXPERTISE IN THE USE OF THE DEVICE. NO SURVEILLANCE DATA WAS PROVIDED. SOME OF THE PTS EXPERIENCING THIS COMPLICATION REQUIRED EITHER ORAL OR INTRAVENOUS ANTIMICROBIAL THERAPY TO TREAT THE INFECTIONS. NO SAMPLES, LOT NUMBERS OR OTHER INFORMATION IS AVIALABLE.
ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO, BUT THE FACILITY WAS UNABLE TO SUPPLY IT TO CO. SUMMARY OF INVESTIGATION: NO SAMPLES OR LOT NUMBERS WERE AVAILABLE FROM THE REPORTING FACILITY. THE FACILITY CONTACT STATES THAT SHE BELIEVED THE INCREASE IN INFECTIONS WAS DIRECTLY RELATED TO A LEARNING CURVE WHICH WAS BEING EXPERIENCED BY THE FACILITY'S STAFF DURING A RECENT CONVERSION TO THIS PRODCUT. SHE ALSO STATED THAT THE INFECTION RATE APPEARED TO BE DROPPING AT THIS TIME, AND SHE ATTRIBUTED THE SUBSEQUENT DROP TO THE CLINICIANS GAINING EXPERTISE IN THE USE OF THE DEVICE. INFECTION IS A COMPLICATION OF IV THERAPY WHICH CAN BE CAUSED BY LESS THAN EXPERT INSERTION OR INADEQUATE SECUREMENT OF THE DEVICE DURING DWELL TIME. BOTHE OF THESE CIRCUMSTANCES CAN ALLOW FOR THE INTRODUCTION OF INFECTIOUS AGENTS INTO THE PT'S SYSTEM. PACKAGE INSTRUCTIONS, WHICH ACCOMPANY THE PRODUCT, ADVISE THE USER TO EMPLOY ADEQUATE ASEPTIC TECHNIQUE AND TO SECURE THE DEVICE ACCORDING TO FACILITY POLICY. IT HAS BEEN DETERMINED THAT THE REPORTED COMPLICATIONS WERE DIRECTLY RELATED TO IMPROPER METHODS EMPLOYED BY THE STAFF AT THIS FACILITY. THE CONCERNS RESOLVED AS THE STAFF WERE ABLE TO INCREASE THEIR EXPERTISE IN PRODUCT USAGE. ATTEMPTS HAD BEEN MADE BY CO'S SALES REP, PRIOR TO THIS REPORT, TO GIVE CLINICAL SUPPORT TO THE STAFF, BUT IT WAS REPORTEDLY REFUSED BY THE FACILITY. THE FACILITY WILL BE ADVISED OF CO'S FINDINGS, AND PROPER INSERTION INSTRUCTIONS WILL BE REVIEWED WITH THEM.
PT ADMITTED AS NEW AML 1/2/95 AND DIED ON 1/18/95. PT HAD POSITIVE PSA CULTURES. DATE OF EVENT 1/2/95 - 1/18/95. ABSTRACT ATTACHED.
3/26/91-LEFT KNEE REPLACEMENT. PT FELL AFTER THIS SURGERY AND ALSO GAINED APPROX 100 LBS. ON 4/1/96, PT HAD REVISION LEFT TOTAL KNEE ARTHROPLASTY.
CONCLUSION STATEMENT: RECORDS REVIEWED OF PRODUCT LOT FILE AND FOUND TO BE COMPLETE, ACCURATE, AND ACCEPTABLE. PRODUCT WAS MANUFACTURED AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.
DURING A BLADDER STONE FRAGMENTING PROCEDURE, DEVICE WAS USED. PT EXPIRED 36 HRS LATER. AUTOSPY REVEALED 2 PERFORATIONS ON THE PT'S BLADDER WALL.
THE DEVICE TUBING SEVERED WHILE IN USE AND REQUIRED A CUTDOWN PROCEDURE TO RETRIEVE THE SEVERED PORTION OF THE TUBING. THE FACILITY REVIEWED THIS OCCURRENCE AND DETERMINED THAT THE PT MOST LIKELY CAUSED THE EVENT BY THE ACTIVITY HE ENGAGED IN. THE PT WAS DESCRIBED AS HYPERACTIVE AND HAD BEEN WITNESSED TO BE "PLAYING WITH BED CONTROLS", "TAMPERING WITH THE IV PUMP," AND "MOVING THE PULSE OXIMETER OFF HIS FINGER." IT WAS REPORTED THAT, ON THE DATE OF THE OCCURRENCE, THE PT WAS OUT OF BED WITH THE IV ADMINISTRATION TUBING STRETCHED. THE SAMPLE WAS NOT EXAMINED AND WAS DISCARDED AT THE FACILITY. NO OTHER INFO WAS AVAILABLE.
ATTEMPTS WERE MADE TO RETRIEVE A SAMPLE AND OBTAIN ADD'L INFO. SUMMARY OF INVESTIGATION: NO SAMPLES OR LOT NUMBERS WERE PROVIDED BY THE CUSTOMER. THE FACILITY REPORTED THAT THE PT WAS ASSESSED AS HYPERACTIVE, AND THAT THEY BELIEVED HE CAUSED THE CATHETER SEVERANCE BY HIS HYPERACTIVE STATE. NO DESCRIPTION OF THE SEVERED CATHETER WAS AVAILABLE. IT HAS BEEN CO'S EXPERIENCE THAT A CATHETER WILL SEVER IF IT HAS BEEN DAMAGED BY IMPROPER USAGE PROCEDURES. SEVERANCE CAN OCCUR WITH ANY INTRAVENOUS CATHETER WHEN IMPROPER PROCEDURES ARE EMPLOYED. THERE ARE SEVERAL WAYS THAT A USER MAY INDUCE A CATHETER SEVERANCE: THE USE OF SCISSORS NEAR THE SITE, THE REINSERTION OF THE INTRODUCER NEEDLE AND THE USE OF NEEDLES LONGER THAN ONE INCH DURING FLUSHES OR MEDICATION ADMINISTRATION. THESE PRACTICES WILL RESULT IN EITHER A CUTTING OR PUNCTURING OF THE CATHETER TUBING. DEVICE INSTRUCTIONS, WHICH ACCOMPANY THE PRODCUT, ADVISE THE CUSTOMER AGAINST SUCH PRACTICES. BASED ON AVAILABLE INFO AND PAST EXPERIENCE, IT IS CONCLUDED THAT THE CATHETER TUBING MOST LIKELY WAS DAMAGED BY AN EXTERNAL CUTTING OR PUNCTURING FORCE WITH SUBSEQUENT EXPOSURE TO A COMPRESSIVE FORCE OR THE APPLICATION OF TENSION. THE PT'S REPORTED HYPERACTIVITY MAY HAVE BEEN A CONTRIBUTING FACTOR. THE CUSTOMER WILL BE ADVISED OF CO'S FINDINGS. THE PACKAGE INSTRUCTIONS ON CORRECT INSERTION AND MAINTENANCE OF THE DEVICE WILL BE REVIEWES, AS WELL AS THE USUAL CAUSES OF CATHETER SEVERANCE.
PT RECEIVED BREAST IMPLANTS ON 12/13/84. DESCRIPTION OF ALLEGATIONS: SYMPTOMS: HIGHLY SUSPECT DUE TO "SILICONE GEL BLEED" SIGNIFICANT WEIGHT LOSS AFTER SURGERY, RHEUMATOID ARTHRITIS (DIAGNOSED BY ONCOLOGIST TRYING TO HELP RPTR), PANIC ATTACKS CHRONIC, BONE PAIN CHRONIC SEVERE, GENERAL ALL OVER BONE PAIN, DAILY (INTERMITTENT), FEVER CHRONIC LOW GRADE, SWELLING CHRONIC, LEGS, ANKLES, ARMS, FEET, ABOVE BASE OF SPINE, UNABLE TO WALK, HAVE TO USE A CRUTCH, PAINFUL & FUNCTION AS SHE DID, GETTING WORSE! UNEXPLAINED BRUISING DIFFERENT PARTS OF BODY PROBABLE NEUROLOGICAL PROBLEMS, (MUSCLE SPASMS PARKINSONS? TWITCHING INVOLUNTARY SPASMS) DISABLING MIGRAINE HEADACHES, BLURRED VISION & LOSS OF VISION OCCASIONAL, RASHES CHRONIC, ABNORMAL BLEEDING CHRONIC, LESIONS, WOUNDS ON SCALP, FACE, ARMS, LEGS, BUTTOCKS, RIB CAGE SCAB, BLEED, HURT, VOMITING COMES AND GOES. "CHRONIC FATIGUE (B-12 INJECTIONS 1990 FOR CHRONIC FATIGUE), BLADDER INCONTINENCE, LUMPS, SILICONE DEPOSITS? LARGE ONE ON LEFT FOREARM, SWOLLEN LYMPH GLANDS, NECK, GROIN, ETC. RESTRICTED ARM MOVEMENT IN GENERAL, INSOMNIA, DAY AND NIGHT SWEATS, DIZZINESS, NUMBNESS, TINGLING, WAS TOLD BY G.P. PT HAS OSTEOPOROSIS '89, TMJ WORSENED-HAVE TO WEAR BRACE AND ANKLE BRACE NOW EVERY DAY, CIRCULATORY PROBLEMS-PALMS AND FINGERS ON HANDS AND BOTTOMS OF FEET ALWAYS RED. BLADDER INFECTIONS (HIGH SCHOOL AND EARLY TWENTIES MOSTLY), YEAST INFECTIONS, DYSMETRIA, BAD CRAMPS-BUT VERY REGULAR MENSES. SORE THROAT-CHRONIC, SWOLLEN AND PAINFUL NODES ON NECK, CHRONIC MOUTH ULCERS-PT CAN'T DRINK CARBONATED LIQUIDS OR JUICES ONLY WATER, PAIN HAS GOTTEN SO BAD PT CLENCHED HER TEETH SO HARD PT CRACKED OFF TWO BACK TEETH. SHORTENED MEMORY LOSS, VERY DRY SKIN, HAIR LOSS, LESIONS ON FACE, ARMS, LEGS, EAR, SCALP EXUDE STICKY SUBSTANCE, BLEED AND SCAB. SHORT PERIODS OF REMISSION: GETTING SHORTER. HER CONDITION HAS PROGRESSIVELY DETERIORATED AND PT NEEDS HER DAUGHTERS/HUSBAND TO HELP HER WITH THE SIMPLEST OF TASKS, E.G. BATHE, GET FROM BED TO THE BATHROOM. SINCE SHE IS HOME ALONE THE KIDS ARE AT SCHOOL AND HUSBAND IS AT WORK, PT CRAWLS ON HER KNEES. PT HAS VIRTUALLY BECOME A SHUT-IN OVER TIME WITHIN LAST FIVE YEARS. AT THIS POINT EXPLANTATION DOESN'T SEEM TO BE AN OPTION FOR HER. PT IS DISABLED AND NEEDS FAMILY ASSISTANCE. REFERENCE MEDWATCH 1009833 AND MW072385.
CLOSED CHEST CABG PROCEDURE PERFORMED. CATHETER WAS THREADED INTO AND DISSECTED AORTA. PT'S CHEST OPENED AND THE INJURY WAS REPAIRED. PT ARRESTED AND EXPIRED SOON THEREAFTER.
IMMEDIATELY AFTER THE PLACING OF 4.0 FR PICC PT BEGAN TO HAVE ABDOMINAL CRAMPS, CHEST TIGHTENES; SOB & FACIAL STINGING. BP 180/120 HR=110. PT WAS VERY FLUSHED AND WITHOUT. NL BREATH SOOTHES AND WHEEZE PICC WAS PULLED IMMEDIATELY AND ALL SIGNS AND SYMPTOMS WERE GONE IN 5 - 10 MINS.
DATE SENT TO FDA: 10/11/96. B4, F8, G4-MFR ALERT DATE. C-INFO NOT APPLICABLE TO THIS REPORT. F9-ADD'L PT CODES: 2328, 1840. ATTEMPTS TO CONTACT REPORTER FOR ADD'L INFO WERE UNSUCCESSFUL.
THE PT'S WIFE REPORTED THAT THE PT OBTAINED HIGHER BLOOD GLUCOSE READINGS WITH STRIPS. TWO WEEKS AGO, THE PT WAS USING TEST STRIPS (LOT UNK). AT THIS TIME, HE WAS OBTAINING BLOOD GLUCOSE READINGS IN THE 300 MG/DL RANGE. SOME TIME LAST WEEK, THE PT OPENED THE BOTTLE OF CO'S STRIPS AND THROUGHOUT THE WEEK OBTAINED BLOOD GLUCOSE READINGS IN THE 485-500 MG/DL RANGE. THIS IS THE FIST BOTTLE OF TEST STRIPS THE PT HAS EVER USED. BECAUSE THE PT FELT THE READINGS OBTAINED WITH STRIPS WERE INACCURATE, HIS WIFE SPOKE WITH A CO'S REPRESENTATIVE ON 8/7/96. THE CONTACT WAS UNWILLING TO PERFORM A BLOOD GLUCOSE TEST WITH THE REPRESENTATIVE. THE PT WAS NOT AVAILABLE TO PERFORM A SIDE BY SIDE COMPARISON WITH CO'S STRIPS AND DIFFERENT TEST STRIPS. THE CONTACT DID NOT HAVE NORMAL CONTROL SOLUTION AVAILABLE TO CHECK EITHER BRAND OF TEST STRIPS FOR ACCURACY. THE CONTACT WAS UNWILLING TO PERFORM A CHECK STRIP TEST ON THE PT'S METER. THE DESICCANT IS IN THE BOTTLE OF STRIPS. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE CONTACT CANNOT PROVIDE THE LOT NUMBER OF THE TEST STRIPS OR RETURN THEM FOR EVALUATION BECAUSE THEY WERE DISCARDED. THE CONTACT DENIED THE REPRESENTATIVE'S OFFER OF REPLACEMENT TEST STRIPS.
THE DEVICE FUNCTIONED PROPERLY FROM THE TIME OF ORIGINAL IMPLANT UP TO AND INCLUDING WHEN THE PT WENT ON VACATION. THE PT WENT TO SLEEP WITH COMPLETE DEVICE FUNCTIONALITY. UPON AWAKING THE NEXT MORNING (EXACT DATE UNKNOWN), HE WAS UNABLE TO PERCEIVE SOUND (NO "LINK" OR COMMUNICATION BETWEEN THE ICS AND THE SPEECH PROCESSOR). THE FAMILY RETURNED FROM VACATION THE FOLLOWING WEEK. THE PT WAS SEEN AT THE IMPLANT CENTER ON 8/23/96. DIFFERENT SPEECH PROCESSORS, HEADPIECES/CABLES, AND PORTABLE COCHLEAR IMPLANT TESTERS WERE MADE ON 8/28/96. WHEN THOSE EFFORTS WERE UNSUCCESSFUL, THE PT WAS SCHEDULED FOR REVISION SURGERY.
SECTION 6- CODE 86: DEVICE EVAL CONSISTS OF THE FOLLOWING: A REVIEW OF THE DEVICE HISTORY RECORD (DHR); VISUAL EXAMINATION; BRIGHT LIGHT EXAMINATION; X-RAY EXAMINATION; ELECTRICAL TESTING; LEAK TESTING; CASE REMOVAL; INTERNAL VISUAL EXAMINATION; INTERNAL ELECTRICAL TESTING. SECTION 6- CODE 68: THE CERAMIC CASE WAS CRACKED; MOST PROBABLY THE RESULT OF AN IMPACT THE PT MIGHT HAVE RECEIVED PRIOR TO THE MALFUNCTION. THE CRACK COMPROMISED THE HERMETICITY OF THE ENCLOSURE CONTAINING THE HYBRID. INTRUSION OF MOISTURE LEG TO THE MALFUNCTION OF ELECTRONIC CIRCUITRY WHICH, IN TURN, CAUSED A LOSS OF LINK.
ACCOUNT RECEIVED A DISCREPANT RESULT FOR FERRITIN ON A PT SAMPLE. THE SAMPLE WAS TESTED IN DUPLICATE FOR RESULTS OF 0.00 NG/ML AND 0.00 NG/ML. THE SAMPLLE WAS SENT TO A REFERENCE LAB FOR A RESULT OF 40.2 MCG/L. NO REPORT OF INJURY
PRODUCT LABELING DOES NOT REFERENCE THE EVENT. EVENT HAS NOT OCCURRED WITH GREATER SEVERITY THAN IS USUAL. FREQUENCY IS FGREATER THAN USUAL. THE CO DOES NOT INTEND TO SUBMIT ADD'L INFO.
DURING A DIALYSIS TREATMENT, IT WAS REPORTED THAT THE UF (FLTRAFILTRATION) PUMP THERMAL FUSE FAILED. THERE WAS NO FURTHER INFO AVAILABLE. THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD.
FAILURE OF THE ULTRAFILTRATION (UF) PUMP THERMAL FUSE. NO FURTHER INFO AVAILABLE FROM THE FACILITY. A REVIEW OF THE DTF AND CPF HISTORIES IS NOT POSSIBLE SINCE THE MACHINE SERIAL NUMBER IS NOT KNOWN. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE TECHNICIAN AT THE FACILITY FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE FAILED THERMAL FUSE WAS NOT RETURNED FOR INVESTIGATION. IT HAS BEEN SEEN PREVIOUSLY THAT A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. THERE WERE TWO OTHER INCIDENTS REPORTED WITH THIS ONE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. CUSTOMER CONTACTED:N. SALES/SERVICE CONTACTED BY INVESTIGATOR:N. TRAINING REQUIRED:N.
THE DEVICE WAS USED DURING AN ANTERIOR RESECTION. IT WAS REPORTED BY THE REP THAT THE PURSE STRING APPLIED USING APPLICATOR AND SUTURE. ANVIL HEAD WITH BLUE TROCAR INSERTED AND SECURED. MAIN INSTRUMENT INSERTED THROUGH THE RECTUM. DIFFICULTY REMOVING BLUE TROCAR BUT SEEMINGLY SUCCESSFUL. PROBLEM WHEN INSERTING THE SPIKE (METAL) THRU THE ANVIL HEAD-NO CLICK HEARD AND DID NOT LOCK. TRIED FOR A WHILE THEN RECLOSED. THERE WAS A SMALL PIECE OF THE BLUE TROCAR LEFT IN THE ANVIL HEAD. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6;H3,4,6;G4: ADDED ADDITIONAL INFO. CONCLUSION: UPON RECEIPT, IT WAS CONFIRMED THAT THE ANCILLARY (BLUE) TROCAR WAS BROKEN OFF INSIDE THE ANVIL SHAFT. IT SHOULD BE NOTED THAT IF TORQUE IS APPLIED TO THE ANCILLARY TROCAR WHILE TRYING TO REMOVE IT FROM THE ANVIL, IT MAY CAUSE THE ANCILLARY TROCAR TO BREAK OFF INSIDE THE ANVIL SHAFT. ADDITIONALLY, IT SHOULD BE NOTED THAT IF FORCE IS APPLIED TO THE LOCKING CLIPS OF THE ANVIL WHILE REMOVING THE ANCILLARY TROCAR, IT WILL CAUSE THE ANCILLARY TROCAR TO BE DIFFICULT TO REMOVE. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
THIS MFR REPORT IS SUBMITTED FOR SERIOUS INJURY AS A RESULT OF MISUSE OF THE DEVICE. THE MFR RECENTLY BECOME AWARE OF THIS CASE WHICH WAS FIRST DESCRIBED ON THE INTERNET BY THE PT. THE CASE INVOLVED A MALE PT WHO WAS ALSO A PHYSICIAN. THE PT, WHO HAD NOT BEEN FASTING, UNDERWENT, AN UNSCHEDULED SURGERY IN WHICH THE DEVICE WAS INAPPROPIATELY USED BY THE ATTENDING HEALTH CARE PROFESSIONALS. (THE DEVICE IS CONTRAINDICATED IN NON-FASTING PTS.) THE PT REGURGITATED AND ASPIRATED HIS GASTRIC CONTENTS. FOLLOWING THIS, AN ENDOTRACHEAL TUBE WAS INSERTED AND THE PT RECEIVED ANTIBIOTICS AND STEROIDS. THE PT WAS PLACED ON A VENTILATOR FOR SIX DAYS. THE PT RECOVERED FROM THE EVENT AND REPORTED NO LONG TERM CONSEQUENCES. THE DEVICE IS CONTRAINDICATED FOR USE IN PTS WHO HAVE NOT FASTED OR IN OTHER SITUATIONS WHERE THERE MAY BE RETAINED GASTRIC CONTENTS. THE DEVICE LABELING CLEARLY STATES THIS FACT IN THE CONTRAINDICATIONS SECTION. FURTHER, THE LABELING EXPLAINS THAT THE DEVICE DOES NOT PROTECT THE AIRWAY FROM THE EFFECTS OF REGURGITATION AND ASPIRATION.
THIS REPORT IS SUBMITTED ON BEHALF OF THE DEVICE MFR. MFR HAS COMPLETED SECTIONS F9-12 ON THIS FORM BECAUSE THIS MDR WAS NOT REPORTED BY USER FACILITY OR DISTRIBUTOR. (USER FACILITY IS LOCATED OUTSIDE US AND WAS NOT REQUIRED TO SUBMIT A REPORT). DEVICE DISTRIBUTOR IS LOCATED OUTSIDE US AND DOES NOT DISTRIBUTE ANY OF DEVICES IN US THEREFORE DISTRIBUTOR IS NOT REQUIRED TO REPORT TO FDA. PLEASE NOTE: MFR IS NOW USING ITS OWN REGISTRATION NUMBER FOR REPORTING. PREVIOUSLY, MFR HAD BEEN USING THE U.S. DISTRIBUTORS'S REPORTING NUMBER (2027158) FOR ID PURPOSES UNTIL ITS OWN NUMBER HAD BEEN ISSUED. THIS REPORT WILL BE CONSIDERED CLOSED UNLESS ADD'L INFO IS RECEIVED ABOUT REPORT. PT IS A 46 Y/O MALE RE-ADMITTED TO THE HOSP ON 5/25TH, WITH A NEPHRITIC COLIC DUE TO URETERAL STONE. PT WAS DISCHARGED FROM THE SAME HOSP ON THE DAY BEFORE, WHERE HE WAS ADMITTED FOR THE SAME REASON ON 5/22 AND STAYED THERE FOR 2 DAYS RECEIVING ANTISPASMODIC PO AND IV (ATROPINE DERIVATIVES N BUTILBROMURO DE HIOSCINA DIPIRINO) LEAVING THE HOSP WITHOUT PAIN. AT THAT TIME HE INFORMED HOSP STAFF THAT HE MEDICATED HIMSELF WITH 11 TABLETS OF THIS ANTISPASMODIC THAT MORNING AS THE PAIN WAS INTENSE. DURING THOSE 3 DAYS PT PRESENTED WITH NAUSEA AND VOMITING AND WAS TOLD LATER THAT IT WAS DUE TO THE COLIC. ON 25TH OF MAY PT HAD BREAKFAST AT 8:00 AND DRANK DIET COLA DURING MORNING. AT MID-MORNING PAIN FROM STONE SHOWED AGAIN AND PT WENT BACK TO HOSP TO BE ADMITTED AROUND NOON TIME. DEMEROL IM AND MORE ANTISPASMODICS IV WERE PRESCRIBED WHEN ADMITTED. ADMISSION ORDERS AT 13:00 INCLUDED LIQUID DIET SO HE CONTINUED WITH SOME COLA. THEN HE WAS INFORMED THAT THE UROLOGIST WAS GOING TO PERFORM A PROCEDURE(PUT A DOUBLE J, LYTOTRIPSY OR OPEN SURGERY IF NEEDED) AND  ANESTHESIOLOGIST SHOWED UP FOR THE PRE-ANESTETIC EVAL. HE WAS PROGRAMMED FOR SURGERY AT 15:30 AND HE ASKED ABOUT HIS MEDICAL HISTORY, (NO SURGERY OR ANESTHESIA, HEART ARRHYTHMIA TREATED WITH ANSYOLITICS, WEIGHT 185 LBS, 57, AND HIS FOOD AND LIQUID INGESTION OF THAT MORNING). EVERYTHING ELSE SUCH AS CONSTANT NAUSEA AND VOMITING THE PREVIOUS DAYS, HIGH DOSES OF ANTISPASMODICS ADMINISTERED PO AND IV BY MD AND BY THE HOSP STAFF, ONE VOMIT WITH WHAT SEEMED TO BE BLOOD CONTENTS WAS IN MEDICAL RECORD. ACCORDING TO CHART HE WAS PLACED NPO 15 MINUTES BEFORE GOING TO OR. HE WAS CLASSIFIED AS AN ASA II PT, ANESTHETIC PRE-MEDICATION INCLUDED 8 MGS. OF MIDAZOLAM IV, THE INDUCTION WAS WITH PAVALON 2 MGS, FETANYL 100 MCGS, PENTHOTAL 150 MGS, AND SUCCIMILCOLINE 100 MGS. IN O.R. AND DURING THE PLACEMENT OF THE EXPANDER AFTER 45 MINUTES OF G.A. WITH A LMA HE VOMITED AND ASPIRATED APPROX 150-200 CC OF GASTRIC CONTENT WITH SOME BLOODY APPEARANCE AND 800CC MORE WERE ASPIRATED FROM HIS STOMACH. A -7.5 ET WAS PLACED WITH 100% 02. ANTIBIOTICS AND STEROIDS WERE ADMINISTERED AT THAT TIME. DUE TO THIS EPISODE HE SUFFERED SEVERE LUNG DAMAGE WITH LOW OXYGEN SATURATION, THE PROCEDURE WAS CANCELLED AND PT RECEIVED A "BRONCHIAL TOILETTE" AND WAS PLACED ON A VENTILATOR.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE WOULD NOT ARM AND THE ARMING BUTTON WOULD NOT STAY DOWN. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "WOULD NOT ARM AND THE ARMING BUTTON WOULD NOT STAY DOWN" DURING SURGERY MAY HAVE BEEN DUE TO BENT KNIFE STEM. THE INSTRUMENT WAS RECEIVED WITH A TORN OUTER GASKET AND WAS LOCKED OUT AND IN THE ARMED POSITION. THE OBTURATOR STEM WAS OBSERVED TO BE BENT AT THE OBTURATOR HOUSING. THE OBTURATOR WAS UNARMED AND THEN WOULD RE-ARM INTERMITTENTLY. IT WAS CONCLUDED THAT THE BENT OBTURATOR CAUSED THE STACK UP TO BIND WHEN THE RESET BUTTON WAS ACTUATED AND WOULD NOT ALLOW THE INSTRUMENT TO ARM CONSISTENTLY. NO CONCLUSION COULD BE REACHED AS TO HOW THE OBTURATOR STEM HAD BECOME BENT OR AS TO HOW THE OUTER GASKET HAD BECOME TORN. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY.
IT WAS REPORTED THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE BALLOON BURST ON CHOLANGIOGRAM CATHETER FROM PCI KIT. TWO DIFFERENT CATHETERS WERE USED AND THEY EACH BURST. THERE WAS NO CONSEQUENCE TO THE PT.
DEVICE RETURNED WITH NO BATCH IDENTIFICATION. BALLOON BURST.
PT ADMITTED, FROM NURSING HOME, 8/15/96 WITH FUO, ALTERED MENTAL STATUS AND SEPTIC WORK-UP. HOSP LOS UNEVENTFUL. TREATED WITH ANTIBIOTICS. 8/23/96 LEFT VENTRICULOSTOMY INSERTED. 8/31/96 RIGHT VENTRICULOSTOMY REPLACED. 9/11/96 LEFT VENTRICULOSTOMY REPLACED. 9/13/96 NURSE FOUND EXTERNAL DRAINAGE COLLECTION TUBING ON FLOOR. PT LOST APPROX 300-350CC CEREBROSPINAL FLUID (CSF). ADHESIVE TAPE USED TO HOLD TUBING IN PLACE CAME LOOSE. QUESTIONABLE IF DRAINAGE COLLECTION KIT IS DEVICE FAILURE. ADHESIVE TAPE FAILED. 9/17/96 PT EXPIRED.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS ACCORDING TO CLINICIAN 3 IMPLANTS WERE PLACED IN CLASS II BONE DURING A ROUTINE PROCEDURE. THE CLINICIAN REPORTS THAT THE IMPLANT IN SITE #31 DID NOT INTEGRATE AND WAS REMOVED ONE MONTH POST-OPERATIVELY. THE REMAINING 2 IMPLANTS ARE STABLE AND SEEM TO HAVE INTEGRATED SUCCESSFULLY.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS ENDOSSEOUS DENTAL IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
PT RECEIVED AN IMPLANT ON AN UNKNOWN DATE AND OF AN UNKNOWN MFR. REPORTER ALSO ALLEGES PT HAS A RUPTURE.
AFTER INSERTING TUBE INTO CHILD, THEY NOTICED THE TUBE HAD NO HOLES.
MANUFACTURING HAS ALTERED THE PROCEDURE FOR PRODUCTION TO CALL FOR A 100% VISUAL INSPECTION FOR EYES. ADD'L EMPLOYEE TRAINING WAS CONDUCTED AND NOTICES WERE POSTED AT EACH PUNCH WORK STATION.
DURING AN EMERGENCY INTUBATION ATTEMPT ON A 37 YR OLD MALE PT, WEIGHING 195 LBS, WITH A SEVERE HEAD INJURY, THE DISPOSABLE LARYNGOSCOPE BLADE BROKE NEAR THE CONTACT AREA. ONLY THE CONTACT AREA OF THE BLADE WAS SAVED. THE BROKEN PIECE WAS REMOVED FROM THE PT'S MOUTH AND DISCARDED. ANOTHER BLADE WAS SELECTED AND INTUBATION WAS SUCCESSFULLY COMPLETED. THE PT SUCCUMBED TO HIS INJURIES ON 9/6/96. THERE IS NO CAUSAL CONNECTION BETWEEN TO BLADE BREAKING AND THE DEATH OF THE PT.
NOTE: ALL OF THE INFO CONTAINED IN SECTION F WAS PROVIDED BY THE MFR. PRIVILEGED AND CONFIDENTIAL: THE COMPLAINT CANNOT BE INVESTIGATED AS THE BLADE USED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE OF THE BLADE BREAKING IS THAT TOO MUCH FORCE WAS APPLIED WHEN ATTEMPTING TO INTUBATE. BLADE STRENGTH IS TESTED AT RECEIVING INSPECTION TO A SPECIFICATION OF 25 LBS MINIMUM STRENGTH WITHOUT BREAKING INCLUDES A +100% SAFETY FACTOR. STUDIES SHOW THAT PTS NECESSITATING COMPLICATED INTUBATIONS REQUIRED 38% HIGHER AVERAGE FORCE. IT IS EXPLICITLY STATED IN THE PRODUCT INSERT, INS-BLADES/REV. B(5/94) UNDER PRECAUTIONS AND SUGGESTIONS FOR USE, NUMBER 9: "NEVER EXCESSIVE FORCE WHILE PERFORMING AN INTUBATION."
PT ALLEGES SHE RECEIVED IMPLANTS JULY 19, 1983 FROM AN UNKNOWN MFR. PT ALSO ALLEGES SHE HAS MEDICAL PROBLEMS AND NO OTHER SPECIFICS WERE GIVEN.
AS THE PHYSICIAN WAS FINISHING THE CASE AND STARTED TO REMOVE THE CATHETER THE STOPCOCK BROKE OFF AND AIR BUBBLES WERE SEEN IN THE LINE. PT WAS TAKEN FOR X-RAYS TO DETERMINE IF PNEUMOTHORAX WAS PRESENT. PT'S X-RAY WAS CLEAR.
A REPORT WAS RECEIVED OF AN ENDOSSEOUS DENTAL IMPLANT WHICH WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. POOR BONE QUALITY WAS NOTED. THIS IS THE SAME PT AS REPORTED IN #2029012199600016.
86= DIMENSIONAL ANALYSIS. 100=THE RETURNED COMPONENT MET CO VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO CLINICIAN 4 IMPLANTS WERE PLACED IN CLASS II BONE DURING A ROUTINE PROCEDURE. THE CLINICIAN REPORTS THAT POSSIBLE INADVERTANT LOADING  MAY HAVE CAUSED MOBILITY ON THE IMPLANT IN SITE #21. THE CLINICIAN REPORTS THAT THE IMPANT IN SITE #21 WAS REMOVED 3 MONTHS POST-OPERATIVELY.
PT ALLEGES RECEIVING IMPLANTS ON AN UNKNOWN DATE AND OF AN UNKNOWN MFR. PT ALLEGES SHE HAS HAD A RUPTURE.
H3-AVAILABILITY OF DEVICE IS UNKNOWN AT THIS TIME. 68A OTHER (NO DEVICE RETURNED).
A REPORT WAS RECEIVED OF AN ENDOSSEOUS DENTAL IMPLANT WHICH WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION.
86= DIMENSIONAL ANALYSIS. 100= TOOL MARKS WERE NOTED ON THE COLLAR OF THE IMPLANT. THE RETURNED COMPONENT MET THE REMAINING CO VISUAL AND DIMENSIONAL SPECIFICATIONS.
WHILE PT WAS USING LATEX GLOVES SHE DEVELOPED HIVES AND LATER ON IT PROGRESSED INTO ASTHMA. PT TOOK MEDICATION WITHOUT ANY POSITIVE RESULTS. PT WAS REQUIRED TO CARRY AND EPI-PEN, A PROVENTIL INHALER AND ANATRAC. PT IS NO LONGER WORKING AS AN RN. PT STATED THAT EVERYTIME SHE GOES TO A GROCERY STORE OR A TOY STORE SHE GETS AN ALLERGIC REACTION.
AN INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE ANY PRODUCT OR LOT NUMBER INFO. RPTR HAS REQUESTED ANONYMITY. MEDWATCH FORM NUMBER: 1009964.
DURING A FISTULA GRAFT PROCEDURE, THE CATHETER BALLOON RUPTURED. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
BLOCK B6 & B7 CHANGED TO UNKNOWN AS SEVERAL ATTEMPTS WERE MADE TO NO AVAIL TO OBTAIN THE INFO BLOCK D6 & F9 WERE MADE AVAILABLE UPON SAMPLE RECEIPT.CODE 2199-NOT LABELED. CODE 1049-LABELED.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO CLINICIAN 2 IMPLANTS WERE PLACED IN CLASS I BONE DURING A ROUTINE PROCEDURE. THE CLINICIAN REPORTS THAT THE IMPLANT IN SITE #18 WAS PLACED IN EXTREMELY DENSE BONE WHICH COULD POSSIBLY HAVE CAUSED THE TEMPERATURE OF THE BONE TO ELEVATE AND OVERHEAT. EXCELLENT PRIMARY STABILITY OF THE IMPLANT WAS ACHIEVED HOWEVER. THE CLINICIAN REPORTS THAT THE IMPLANT WAS REMOVED ONE MONTH POST-OPERATIVELY.
86= DEVICE NOT RETURNED. 100=DEVICE NOT RETURNED, THEREFORE, AN EVALUATION OF THE PRODUCT WAS NOT COMPLETED. IN ADDITION, THE LOT NUMBER WAS NOT AVAILABLE.
ATTORNEY ALLEGES PLAINTIFF RECEIVED BREAST IMPLANTS IN 1980. ATTORNEY ALSO ALLEGES, "IN OR ABOUT 1992, THE PLAINTIFF BEGAN TO EXPERIENCE MAJOR HEALTH PROBLEMS INCLUDING SLEEP DISTURBANCES, CHRONIC FATIGUE AND HAS BEEN DIAGNOSED SUBSEQUENTLY WITH ARTHRITIS IN HER LEGS, HIP, KNEES, AS WELL AS IN HER JAWS. ON APRIL 3,195 SHE ATTENDED A PHYSICIAN WHO DIAGNOSED A RUPTURED IMPLANT (INTRACAPSULAR, BILATERAL) AND ON THE 11TH OF OCTOBER, THE PLAINTIFF UNDERWENT SURGERY FOR CAPSULAR CONTRACTURE OF THE BREAST TISSUE. THE OPERATIVE REPORT INDICATED THAT THE SILICONE GEL IMPLANTS THAT WERE MANUFACTURED BY CO BOTH HAD SMALL HOLES IN THEM AND GEL WAS EXTRUDING INTO THE TISSUE SURROUNDING THEM. THE SILICONE GEL IMPLANTS WERE REMOVED AND NEW SALINE IMPLANTS REPLACED THEM. THE PLAINTIFF CLAIMS THAT THE SAID IMPLANTS WERE DEFECTIVE AND THAT GEL WAS ALLOWED TO ENTER HER BODY, AND IN DOING SO, CAUSED HER IRREPARABLE DAMAGE."
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO CLINICIAN ONE IMPLANT WAS PLACED IN SITE #7 DURING A COMPLEX PROCEDURE REQUIRING GRAFTING. THE CLINICIAN REPORTS THAT THE IMPLANT WAS SUBMERGED AND WAS REMOVED 8 MONTHS POST-OPERATIVELY.
IMPLANT WAS EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. THE PT HAS HEART AILMENTS FOR WHICH SHE TAKES MEDICATION.
86 & 100= DEVICE NOT RETURNED FOR EVALUATION.
BLOCK B6 & B7 WERE CHANGED TO "UNK" AS SEVERAL ATTEMPTS WERE MADE TO NO AVAIL TO OBTAIN THE INFO BLOCK D6 & F9 WERE MADE AVAILABLE UPON SAMPLE RECEIPT CODE 1049-LABELED CODE 2199-NOT LABELED.
THE RRT REPORTED THAT SHE WAS CALLED TO THE BEDSIDE BY THE RN, BECAUSE THE VENTILATOR WOULD NOT CYCLE. THERE WAS A LEAK IN THE CIRCUIT THAT SHE CORRECTED, BUT THE PEEP WOULD NOT GO BELOW +8 CMH20. SHE CHANGED THE PEEP COLUMN SEVERAL TIMES AND ALSO CHANGED THE CIRCUIT WITHOUT CORRECTING THE PROBLEM. THEREFORE SHE CHANGED THE VENTILATOR OUT.
THE FIELD SERVICE REP STATED THAT HE HAD BEEN TO THE HOSP AND INSPECTED THE VENTILATOR. HE COULD NOT DUPLICATE THE EVENT, BUT AS A PRECAUTION REPLACED THE EXHALATION VALVE BLOCK AND THE PCB. HE OVPD THE UNIT AND IT MET ALL MANUFACTURERS SPECS. THE FIELD SERVICE REP STATED THAT HE FOUND ROUND HEAD SCREWS DID HOLD OFF THE EXHALATION BLOCK CAUSING IT NOT TO SEAT CORRECTLY.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO CLINICIAN, 4 IMPLANTS WERE PLACED IN A ROUTINE PROCEDURE. THE CLINICIAN REPORTS THAT THE IMPLANT IN SITE #30 DID NOT INTEGRATE AND WAS REMOVED 6 MONTHS POST-OPERATIVELY. CLINICIAN ADVISES THAT IMPLANT FAILURE MAY BE ATTRIBUTABLE TO AN UNDETECTED LINGUAL DEHISENCE.
THE DEVICE WAS REMOVED AS THERE WAS "ANEURISM IN THE RIGHT CYLINDER." THE CYLINDER(S) AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED.
ACCORDING TO THE AVAILABLE INFO THIS DEVICE WAS IMPLANTED ON 3/18/96 AND REVISED ON 9/4/96 DUE TO AN "ANEURYSM IN RIGHT CYLINDER." REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES.
IMPLANT WAS EXPLANTED DUE TO A FRACTURED BASKET. THE PT HAS A HISTORY OF LOOSE SCREWS.
86= DIMENSIONAL ANALYSIS. 100= VISUAL EXAM SHOWED THAT THE IMPLANT WAS FRACTURED IN THE AREA OF THE BASKET. THE BASKET PORTION OF THE IMPLANT WAS NOT RETURNED, THEREFORE, A COMPLETE DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. THE RETURNED COMPONENT MET THE REMAINING CO VISUAL AND DIMENSIONAL SPECIFICATIONS. 68=THE PT'S HISTORY OF LOOSE SCREWS IS MOST LIKELY A CONTRIBUTING FACTOR.
PT RECEIVED IMPLANTS IN 1983. REPORTER ALSO ALLEGES PT'S IMPLANTS ARE LEAKING INTO BREAST.
CLINICIAN PLACED ENDOSSEOUS DENTAL IMPLANT, BUT THE IMPLANT NEVER ACHIEVED PRIMARY STABILITY AND WAS REMOVED IMMEDIATELY.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. A POSSIBLE  HEMATOMA AND INFECTION WERE NOTED.
86= DIMENSIONAL ANALYSIS. 100= THE RETURNED COMPONENT MET CO VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER BALLOON RUPTURED. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
BLOCK B6 & B7 WERE CHANGED TO "UNK" AS SEVERAL ATTEMPTS WERE MADE TO NO AVAIL TO OBTAIN THE INFO BLOCK D6 (LOT#) WAS CHANGED & BLOCK F9 WAS ADDED AS A RESULT OF SAMPLE RECEIPT CODE 1049-LABELED.CODE 2199-NOT LABELED.
ATTORNEY ALLEGES PLAINTIFF RECEIVED A RIGHT IMPLANT IN 1992, AS A REPLACEMENT. ATTORNEY ALSO ALLEGES PLAINTIFF HAS EXPERIENCED MAJOR HEALTH PROBLEMS INCLUDING ARTHRALGIA, PAIN IN THE HANDS, WRIST, SHOULDERS, HIPS, ANKLES AND FEET, ECZEMA, MITRAL VALVE PROLAPSE, CARDIAC ARRHYTHMIAS, NASAL DRYNESS, CANKER SORES AND DRY SKIN AS WELL AS WEIGHT LOSS, CHRONIC FATIGUE AND MIGRAINES. THE CLIENT SUFFERED COMPLICATIONS THROUGH PREGNANCY. THE PLAINTIFF CLAIMS THAT THE IMPLANTS WERE DEFECTIVE AND THAT THE GEL WAS ALLOWED TO ENTER HER BODY, AND IN DOING SO, CAUSED HER IRREPARABLE DAMAGE. IN JUNE, 1994 THE PLAINTIFF'S RIGHT IMPLANT WAS "EXCISED" AND NOT REPLACED. REFERENCE MW072375.
THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION." THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A CO'S 3-PIECE INFLATABLE PENILE PROSTHESIS.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 9/13/95 AND REMOVED ON 9/4/96 DUE TO A "MALFUNCTION." IN THE RECEIVED INFO THE MD STATED THAT THE NATURE OF THE "MALFUNCTION" WAS AN "ABRUPT FLUID LOSS." DURING SURGERY THE RESERVOIR AND THE CYLINDERS WERE NOTED TO BE EMPTY. THE MD FURTHER STATED THAT THERE WERE NOTHING APPARENT IN THE PT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE. QA WAS UNSUCCESSFUL INSECURING THE EXPLANTED PROSTHESIS FOR EVAL. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QA IS PRECLUDED FROM THE CONFIRMING ANY OBSERVATIONS AND PRECULDED FROM COMMENTING ON THE CONDITION OF THE PRESOTHESIS. SHOULD THE EXPLANTED DEVICE BECOME AVAILABLE, OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES.
DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER BALLOON WOULD NOT INFLATE ON THE FIRST ATTEMPT. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS BEING REPORTED.
BLOCK B6 & B7 CHANGED TO "UNK" SEVERAL ATTEMPTS WERE MADE TO OBTAIN THE INFO TO NO AVAIL. BLOCK D6 & F9 WERE MADE AVAILABLE UPON RECEIPT OF THE SAMPLE BLOCK F10, DEVICE CODE 1049, WAS ADDED AS A RESULT OF THE SAMPLE EVAL CODE 2199-NOT LABELED. CODE 1310-LABELED. CODE 1049-LABELED.
LEAKAGE WAS NOTICED IN THE DISTAL END OF THE VALVE FIVE DAYS AFTER SURGERY.
DEVICE WAS EXAMINED AND EVALUATED FOR PATENCY BY CO. A SMALL CUT WAS SEEN IN DOME MATERIAL ON THE TOP RIGHT SIDE OF MEMBRANE CASING. WHEN TESTED FOR PATENCY, THE PRODUCT LEAKED OUT OF DAMAGED AREA. DUE TO THE DAMAGE, THE PRODUCT COULD NOT BE TESTED FOR PRESSURE/FLOW CHARACTERISTICS OR PREIMPLANTATION PRESSURE. THE DAMAGE TO THE PRODUCT WAS MOST LIKELY CAUSED BY MISHANDLING.
PT IN SURGERY FOR A RIGHT LEG REVASCULARIZATION. DURING THE PROCEDURE, THE BULLET END OF THE TUNNELER BECAME DISENGAGED. AN X-RAY AND FLUOROSCOPE WAS REQUESTED. THE SURGEON LOCATED THE BULLET TIP AND REMOVED IT FROM THE LEG.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. POOR BONE QUALITY WAS NOTED. THIS IS THE SAME PT AS REPORTED IN #20290112199600015.
86 =DIMENSIONAL ANALYSIS. 100 =THE RETURNED COMPONENT MET CO VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
RECENT MULTIPLE EMBOLIC PNEUMONIA AND BACTERIAL ENDOCARDITIS.
ON 11/17/92 A DEVICE WAS IMPLANTED. INFO RECEIVED ON 9/13/96 INDICATES THE PT COULD NOT INFLATE HIS DEVICE.
ATTORNEY ALLEGES PLAINTIFF RECEIVED IMPLANTS IN 1983. ATTORNEY ALSO ALLEGES, "COMMENCING IN OR ABOUT 1989, THE PLAINTIFF BEGAN TO EXPERIENCE MAJOR HEALTH PROBLEMS INCLUDING ARTHRALGIA, PAIN IN THE HANDS, WRIST, SHOULDERS, HIPS, ANKLES AND FEET, ECZEMA, AND HAD TO UNDERGO A HYSTERECTOMY IN 1992, MITRAL VALVE PROLAPSE, CARDIAC ARRHYTHMIAS, NASAL DRYNESS, CANKER SORES AND DRY SKIN AS WELL AS WEIGHT LOSS, CHRONIC FATIGUE AND MIGRAINES. THE CLIENT SUFFERED COMPLICATIONS THROUGH PREGNANCY. FURTHER, IN 1992 THE CLIENT WAS FORCED TO UNDERGO AN EXPLANT OF THE RIGHT SIDE AND ANOTHER IMPLANT WAS INSERTED INTO HER BREAST. THE PLAINTIFF CLAIMS THAT THE SAID IMPLANTS WERE DEFECTIVE AND THAT THE GEL WAS ALLOWED TO ENTER HER BODY, AND IN DOING SO, CAUSED HER IRREPARABLE DAMGE." IN JUNE, 1994 THE PLAINTIFF'S LEFT IMPLANT WAS "EXCISED" AND NOT REPLACED. REFERENCED MW072375A.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE  CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES. D.6 UNABLE TO DETERMINE WHETHER THIS DEVICE WAS MANUFACTURED BY CO. NO CATALOGUE NUMBER OR OTHER DEVICE IDENTIFIER WAS PROVIDED TO CO.
ON THE FIRST INFLATION ATTEMPT, A HOLE WAS NOTED IN THE CATHETER SHAFT. THE CATHETER WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS BEING REPORTED.
BLOCK D6-LOT NUMBER WAS MADE AVAILABLE UPON SAMPLE RECEIPT & CHANGED ON THIS REPORT. CODE 2199-NOT LABELED. CODE 1628-LABELED.
D5. THIS EXPIRATION DATE DOES NOT CONFORM TO OUR STANDARD EXPIRATION DATING FORMAT - UNK SOURCE FOR THIS DATE.
ADDITIONAL INFO: 15-20 HOURS AFTER INSERTION OF THE DEVICE, THE PATIENT DEVELOPED SIGNS OF PERITONITIS (PAIN, HARDENED ABDOMEN). 30 HOURS AFTER PLACEMENT, IT WAS REMOVED AND A LAPAROTOMY WAS PERFORMED SHOWING THAT THE STOMACH WAS INJURED. PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT AND TREATED. PATIENT EXPIRED 3-4 DAYS LATER. NO AUTOPSY PERFORMED. THE THREE PHYSICIANS INVOLVED CAN'T EXPLAIN WHY PERITONITIS OCCURED. THE GUIDEWIRE NEVER WAS   (UNREADABLE) AND THEY SAID IT WAS A PERFECT PROCEDURE. ENDOSCOPY PERFORMED DIRECTLY AFTER THE INSERTION OF THE PEG SHOWED NO ABNORMAL FINDINGS AND NO BLEEDING. THEY ASSUME THE PATIENT HAD BEEN INJURED DURING INSERTION, BUT THEY DON'T KNOW HOW. THE PATIENTS POOR HEALTH CONDITION MAY HAVE CONTRIBUTED TO THE EVENT.
REPORTER ALLEGES PLAINTIFF RECEIVED MAMMARY IMPLANT ON THE RIGHT SIDE IN 1973. REPORTER ALSO ALLEGES "AT THE BEGINNING OF THE 1980'S THE PLAINTIFF BEGAN TO EXPERIENCE MAJOR HEALTH PROBLEMS. IN 1987 THE PLAINTIFF WAS DIAGNOSED WITH LUPUS. AS WELL, THE PLAINTIFF SUFFERS FROM RASHES, CHRONIC FATIGUE, ARTHRITIS, ANEMIA AND VITAMIN DEFICIENCY, AS WELL AS OTHER HEALTH RELATED DIFFICULTIES." PLAINTIFF ALLEGES THAT GEL WAS ALLOWED TO ENTER HER BODY, AND IN SO DOING, CAUSED HER IRREPARABLE DAMAGE.
DEVICE WAS REMOVED FROM THE PT DUE TO DEFLATING PRIOR TO AND PRECLUDING COITUS. ANOTHER DEVICE WAS IMPLANTED.
CUSTOMER STATES THAT HER DAUGHTER BECAME PREGNANT DUE TO A FAILED CONDOM. THE DAUGHTER HAS TERMINATED THE PREGNANCY. CONDOMS ARE ALLEGED TO SPLIT DURING USE.
ADD'L INFO RECEIVED 11/21/97 INDICATES THAT AN EXPLANT OF THE DYNAFLEX DEVICE WAS ATTEMPTED ON OR ABOUT 9/16/96, HOWEVER THE REMOVAL WAS CANCELLED DUE TO COMPLICATIONS. DR APPARENTLY ATTEMPTED TO PASS FOLEY CATHETER UNDER GERERAL ANESTHESIA; WHILE WAITING FOR A COUDE CATHETER, A SUPRAPUBIC INCISION WAS MADE. UNABLE TO PASS COUDE CATHETER - UNABLE TO PASS FILIFORMS AND FOLLOWERS EITHER; FLEXIBLE CYSTOSCOPE ORDERED. A FALSE PASSAGE IN POSTERIOR URETHRA SEEN. THE PROCEDURE WAS TERMINATED.
THIS EVENT WAS REPORTED AS "DEGENERATION". NO FURTHER INFO PROVIDED.
THE DEVICE WAS USED DURING A THORACOSCOPIC PROCEDURE. REPORTEDLY, THE INSTRUMENT FIRED AND WOULD NOT RELEASE FROM THE APPLICATION SITE. THE HOSP COULD NOT PROVIDE ANY ADDITIONAL INFO ON HOW THE DEVICE WAS REMOVED. THE DEVICE WAS REMOVED, RELOADED AND FIRED AGAIN. SUBSEQUENTLY, THE STAPLER BROKE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/1/96 MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
CUSTOMER STATES THAT SHE IS 1 MONTH PREGNANT DUE TO ALLEGED CONDOM FAILURE. SHE CLAIMS THAT THE CONDOMS BROKE DURING USE AND ALSO CONTAINED HOLES PRIOR TO USE.
ATTORNEY'S LITIGATION ALLEGES, "ON OR ABOUT THE 16TH DAY OF NOVEMBER, 1990, THE PLAINTIFF UNDERWENT A BILATERAL BREAST AUGMENTATION." ATTORNEY'S LITIGATION ALSO ALLEGES, "IN OR ABOUT 1990 THE PLAINTIFF BEGAN TO EXPERIENCE MAJOR HEALTH PROBLEMS INCLUDING DEPRESSION, FLU LIKE SYMPTOMS, SLEEP DISTURBANCES, CHRONIC FATIGUE, HAIR LOSS, PAIN IN THE OVARIES, MIGRAINES AND DIGESTION PROBLEMS. ON JUNE 17, 1994, THE CLIENT UNDERWENT A MAMMOGRAM TEST WHICH INDICATED THERE WERE SOME PROBLEMS". ATTORNEY ALSO ALLEGES "IN SEPTEMBER OF 1994, A CONNECTION WAS MADE THAT SOME OF HER DIFFICULTIES MAY BE A RESULT OF HER BREAST IMPLANTS. THE PLAINTIFF CLAIMS THAT HER INJURIES AND PHYSICAL AND MENTAL CONDITION PROBLEMS HAVE BEEN CAUSED BY THE MAMMARY IMPLANTS. PLAINTIFF ALSO CLAIMS THAT THE SAID IMPLANTS WERE DEFECTIVE AND THAT GEL WAS ALLOWED TO ENTER HER BODY".
DURING PTCA THE INFLATOR DEVICE WAS SLOW TO DEFLATE THE BALLOON. THE REPORTED DEFLATION TIME WAS 58 SECONDS. A SYRINGE WAS ATTACHED TO FULLY DEFLATE THE BALLOON. NO PT INJURY WAS REPRTEDLY ASSOCIATED WITH THIS INCIDENT.
THE PRODUCT WAS USED DURING A HYSTERECTOMY PROCEDURE. REPORTEDLY, THE SUTURE BROKE AND THE WOUND DEHISCED SIX DAYS POST-OPERATIVELY. A REOPERATION WAS REQUIRED TO CORRECT THE CONDITION.
10/11/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE DEVICE WAS USED DURING A TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN AFTER FIRING. THE HOSP HAS REPORTED NO PT INJURY OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
10/28/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA BY MFG. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
DURING AN AV FISTULA PROCEDURE, THE CATHETER BALLOON RUPTURED AT 17-18 ATM AND WHEN THE CATHETER WAS REMOVED, WITH RESISTANCE NOTED THE DISTAL TIP AND BALLOON WERE MISSING. THE PT WAS TAKEN TO THE OR FOR REMOVAL OF THE INDWELLING CATHETER PIECE. NO FURTHER COMPLICATIONS WERE REPORTED.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR. BLOCK H6, CONCLUSION CODE 68, USED AS THE CATHETER BALLOON WAS INFLATED ABOVE ITS LABELED INDICATIONS.
10/11/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT FDA BY MFG.
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT OPEN AFTER FIRING. THE SURGEON RESECTED TISSUE TO REMOVE THE INSTRUMENT AND COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.
PARTICULATE WAS SEEN IN THE PT'S EYE DURING A CATARACT EXTRACTION PROCEDURE. FOREIGN MATTER WAS REMOVED WITH A PAIR OF FORCEPS. DOCTOR USED THE HANDPIECE TO FINISH THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS REC'D. THE HANDPIECE FAILED THE FILTER THE FILTER TEST. THERE WERE PARTICLES LESS THAN 79 MICRONS THAT WERE TOO NUMEROUS TO COUNT. THE PARTICLES APPEARED TO BE NON-METALLIC.
A CO SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND THE HANDPIECE. ONE INTERMITTENT VENTING PROBLEM WAS DETECTED WITH THE SYSTEM, BUT IT COULD NOT BE REPRODUCED. THIS CONDITION IS NOT RELATED TO THE REPORTED EVENT. ROUTINE MAINTENANCE WAS PERFORMED. THERE WAS NO REPORTED PROBLEM WITH THE HANDPIECE. PT INFO WAS REQUESTED BUT IT COULD NOT BE PROVIDED BY REPORTER. THIS REPORT WAS MAILED IN TO FDA ON: 10/11/96. THE MFR'S INTERNAL REFERENCE NUMBER IS 9-8886-96. THIS INFO IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
ATTORNEY ALLEGES PLAINTIFF RECEIVED IMPLANTS ON 2/1/84. ATTORNEY ALSO ALLEGES, "ALMOST IMMEDIATELY, THE PLAINTIFF BEGAN TO HAVE DIFFICULTIES AND PAIN FROM THESE IMPLANTS. SHE HAS CONTINUED TO SUFFER DIFFICULTIES INCLUDING PAIN IN BOTH BREASTS AS WELL AS PAIN IN THE JOINTS INCLUDING THUMB, FEET, ANKLES AND HAS SUBSEQUENTLY SEEN A SPECIALIST FOR ARTHRITIS. THE PLAINTIFF ALSO SUFFERS FROM HEADACHES AND FLU-LIKE SYMPTOMS AND HAIR LOSS. THE PLAINTIFF CLAIMS THAT HER INJURIES AND PHYSICAL CONDITION HAVE BEEN CAUSED BY THE MAMMARY IMPLANTS. THE PLAINTIFF CLAIMS THAT THE SAID IMPLANTS WERE DEFECTIVE AND THAT GEL WAS ALLOWED TO ENTER HER BODY, AND IN DOING SO, CAUSED HER IRREPARABLE DAMAGE." ATTORNEY ALSO ALLEGES PLAINTIFF HAD REMOVAL AND REPLACEMENT ON MARCH 13, 1985 INVOLVING A COMPLETE CAPSULECTOMY ON THE RIGHT SIDE AND PART OF THE MUSCLE HAD TO BE REMOVED. A SIMILAR PROCEDURES WAS PERFORMED ON THE LEFT BREAST. REFERENCE MW072378A.
ON THE INITIAL REPORT THE APPROXIMATE AGE OF THE DEVICE WAS INCORRECTLY REPORTED AS 10 MONTHS. THE CORRECT AGE OF THE DEVICE IS 11 MONTHS. NO FURTHER CORRECTED DATA.
NORMAL USAGE WAS INDICATED ON BOTH THE CENTER AND PORT SEPTA WITH NO INTERNAL FRACTURE PLANE DAMAGE FOUND. THE DEVICE DID NOT LEAK WHILE PRESSURIZING THE PORT OR FILLING THE RESERVOIR. THE DEVICE PORT WAS PATENT UPON FLUSHING WITH NO RESISTANCE FELT AND APPROXIMATELY 5ML OF CLEAR, YELLOW, FLUID WITH LIGHT PARTICLES, WHICH TESTED NEGATIVE FOR BLOOD, WAS COLLECTED. THE DEVICE DID NOT FLOW AS RECEIVED. AFTER REMOVING THE DEVICE CAPILLARY TUBING FROM THE DEVICE PORT INLET TUBE, THE CAPILLARY TUBING FLOWPATH WAS EXAMINED MICROSCOPICALLY. AMBER COLORED MATERIAL, WHICH TESTED POSITIVE FOR BLOOD, WAS SEEN COMPLETELY OCCLUDING THE FLOWPATH AT THE DISTAL END. FLOW WAS RESTORED AFTER REMOVING APPROXIMATELY ONE INCH OF CAPILLARY TUBING AND THE DEVICE FLOWED WITHIN ORIGINAL MFR FLOWRATE SPECIFICATIONS. LEAK TESTING CONFIRMED THE DEVICE DID NOT LEAK. NO OTHER DEFECTS OR ANOMALIES WERE FOUND DURING THE DEVICE ANALYSIS. AS PART OF OUR INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO ITS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE REPORT OF A FAILURE TO INFUSE HAS BEEN CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND THE DEVICE ANALYSIS, THE CAUSE OF THIS EVENT APPEARS TO BE BLOOD OCCLUDING THE DISTAL END OF THE DEVICE CAPILLARY TUBING. NO FURTHER INFORMATION IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS - RIGHT CYLINDER.
CYLINDER HAD A WEAR LEAK. CYLINDER HAD A WEAR HOLE IN INNER TUBE
THE DISPOSABLE LOADING UNIT WAS USED WITH A STAINLESS STEEL INSTRUMENT DURING A PNEUMONECTOMY. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY AND A SIGNIFICANT AMMOUNT OF BLOOD WAS LOST. THE SURGEON MANUALLY SUTURED THE APPLICATIONS SITE. THE PT REQUIRED A BLOOD TRANSFUSION. THE HOSP HAS REPORTED THAT PT'S CONDITION IS SATISFACTORY. DEVICE EXPIRATION DATE IS INDICATED AS 5/31/2001.
ATTORNEY ALLEGES PLAINTIFF RECEIVED IMPLANTS ON MARCH 13, 1985 AS REPLACEMENTS. ATTORNEY ALSO ALLEGES, "SHE HAS CONTINUED TO SUFFER DIFFICULITIES INCLUDING PAIN IN BOTH BREASTS AS WELL AS PAIN IN THE JOINTS INCLUDING THUMB, FEET, ANKLES AND HAS SUBSEQUENTLY SEEN A SPECIALIST FOR ARTHRITIS. THE PLAINTIFF ALSO SUFFERS FROM HEADACHES AND FLU-LIKE SYMPTOMS AND HAIR LOSS. ON MARCH 10, 1995 THE IMPLANTS WERE REMOVED PERMANENTLY. THE PLAINTIFF CLAIMS THAT THER INJURIES AND PHYSICAL CONDITION HAVE BEEN CAUSED BY THE MAMMARY IMPLANTS. THE PLAINTIFF CLAIMS THAT THE SAID IMPLANTS WERE DEFECTIVE AND THAT GEL WAS ALLOWED TO ENTER HER BODY, AND IN DOING SO, CAUSED HER IRREPARABLE DAMAGE." REFERENCE MW072378.
DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER # 2658K 0O3, 8139K 005.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT, DUE TO FLUID LOSS, AND REPLACED.
MFR RECEIVED A REPORT FROM AN ATTORNEY OF A POWER WHEELCHAIR BEING INVOLVED IN A FIRE. AS A RESULT OF THIS INCIDENT, THE USER ALLEGEDLY DIED OF SMOKE INHALATION. EXAMINATION OF THE DEVICE HAS NOT BEEN PERMITTED BUT PHOTOGRAPHS HAVE BEEN PROVIDED. THESE PHOTOGRAPHS SHOW THE USE OF UNAUTHORIZED ELECTRICAL COMPONENTS WHICH APPEAR TO HAVE BEEN THE CAUSE OF THE FIRE.
THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION."
THE DEVICE WAS IMPLANTED ON 9/10/96, FOR INFUSION OF FUDR/HEPARIN THROUGH THE GASTRODUODENAL ARTERY FOR TREATMENT OF CANCER. ON 9/20/96, THE FACILITY'S PHARMD INFORMED THE MFR THAT THE EXPECTED MFR'S FLOW RATE OF THE DEVICE=1.6ML/DAY; HOWEVER, THE ACTUAL FLOW RATE OF THE DEVICE IS 2.25 ML/DAY. THE FACILITY'S PHARMD STATED THAT THE PT HAS EXPERIENCED FREQUENT FEBRILE EPISODES SINCE DEVICE IMPLANT ON 9/10/96, WHICH THE PHARMD SUSPECTS IS THE ETIOLOGY OF THE INCREASED FLOW RATE OF THE DEVICE. THE PHARMD WILL MONITOR THE DEVICE FLOW RATES CLOSELY. THE FOLLOWING ARE MAX TEMPERATURES RECORDED SINCE DEVICE IMPLANT: 9/10/96, 38.3 DEGREE CELSIUS, 9/11/96, 38.5 DEGREE CELSIUS, 9/12/96, 38 DEGREE CELSIUS, 9/13/96, 37.7 DEGREE CELSIUS, 9/14/96, 37.4 DEGREE CELSIUS, 9/15/96, 38.3 DEGREE CELSIUS, 9/16/96, 37.8 DEGREE CELSIUS, 9/18/96, 35.9 DEGREE CELSIUS, 9/19/96, 38.1 DEGREE CELSIUS, 9/20/96, 37.2 DEGREE CELSIUS. ADDITIONALLY THE PHARMD INFORMED THE MFR THAT THE PT HAD DEVELOPED A ROUTINE DEVICE POCKET SEROMA WHICH WAS ASPIRATED WITHOUT COMPLICATIONS.
THIS REPORT CONCERNS A DEVICE THAT IS THE SUBJECT OF A CLINICAL STUDY UNDER AN APPROVED INVESTIGATIONAL DEVICE EXEMPTION (IDE). ACCORDING TO 60 FR 237: 63577-63606 CLAUSE 63," DEVICES WITH INVESTIGATIONAL DEVICE EXEMPTIONS THAT ARE APPROVED FOR EXPORT...ARE CONSIDERED TO BE IN COMMERCIAL DISTRIBUTION  AND, THEREFORE, SUBJECT TO MDR." ON 9/26/96, THE PHARMD INFORMED THE MFR THAT THE REFILL PERIOD WAS SIX DAYS, THE RETURN VOLUME=21ML, THE INFUSED VOLUME=11ML AND THE DEVICE FLOW RATE=1.8ML/DAY. NO DIFFICULTY WAS ENCOUNTERED LOCATING OR ACCESSING THE DEVICE CENTER SEPTUM. THE DEVICE POCKET WAS SWOLLEN AND 33ML OF SEROSANGUINOUS FLUID WAS ASPIRATED FROM THE DEVICE POCKET WITHOUT COMPLICATIONS. THE DEVICE REMAINS IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN AT THIS TIME. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION."
MFR RECEIVED A MEDWATCH REPORT DESCRIBING AN INCIDENT INVOLVING A LOOSE JOYSTICK MOUNTING BRACKET ON A POWER WHEELCHAIR, THIS ALLEGEDLY ALLOWED THE JOYSTICK TO ROTATE AND THE USER TO RUN INTO A WALL. AS A RESULT OF THIS INCIDENT, THE USER SUSTAINED A BROKEN LEG. AN EVALUATION OF THE DEVICE AFTERWARD CONCLUDED THE DEVICE OPERATED AS INTENDED WITH NO MALFUNCTION FOUND.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION." ADD'L LOT/SER # 9945L 001, 0207M 009.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER HAD A WEAR LEAK.
ATTORNEY ALLEGES PLAINTIFF RECEIVED IMPLANTS ON 11/17/83. ATTORNEY ALSO ALLEGES, "COMMENCING IN 1986, THE CLIENT BEGAN TO HAVE DIFFICULITIES WITH ARTHRITIS LIKE SYMPTOMS IN HER FINGERS AND SHOULDERS. SHE WAS EVENTUALLY DIAGNOSED WITH ARTHRITIS AND ATTENDS A RHEUMATOLOGIST AS WELL AS HER REGULAR FAMILY DR FOR ONGOING PROBLEMS. AS WELL, THE PLAINTIFF CONTINUES TO HAVE A GREAT DEAL OF DIFFICULTY DURING HER MENSTRUAL CYCLE AND BECOMES VERY ILL DURING SAME. ON OR ABOUT 5/1/95 THE CLIENT UNDERWENT SURGERY FOR BILATERAL REEXPLANTATION OF THE SILICONE IMPLANTS. THE LEFT IMPLANT WAS FOUND TO HAVE RUPTURED. THE PLAINTIFF CLAIMS THAT HER INJURIES AND PHYSICAL CONDITION HAVE BEEN CAUSED BY THE MAMMARY IMPLANTS. THE PLAINTIFF CLAIMS THAT THE SAID IMPLANTS WERE DEFECTIVE, AND THAT GEL WAS ALLOWED TO ENTER HER BODY, AND IN DOING SO, CAUSED HER IRREPARABLE DAMAGE."
A BATTERY HAD FALLEN OUT OF THE LIFT ONTO A NURSE'S FOOT. EXTENT OF INJURY NOT KNOWN. NO FURTHER INFO AVAILABLE.
FOREIGN REPORTER HAS ASSIGNED INVESTIGATOR, AWAITING ENGINEERING EVALUATION AND CLOSEOUT REPORT FORM FOREIGN REPORTER. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. ADD'L INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT. THIS REPORT IS BASED ON INFO SUPPLIED TO US CO WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21 CFR 600, 803, 1002, 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMNISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION - NEEDED FULLER CYLINDER. ANOTHER DEVICE WAS IMPLANTED.
A PT RECEIVED A BURN TO THE THIGH AT THE LOCATION OF WHERE THE CORD WAS RESTING WHICH HAD BEEN CLAMPED WITH A METAL CLAMP. THE METAL CLAMP CAUSED AN INSULATION FAILURE ON THE PENCIL CORD. THE PT'S BURN WAS EXCISED AND SUTURED.
THE GENERATOR MANUAL WARNS AGAINST METAL CLAMPS AND ACCESSORY CORD. ADDITIONALLY, THE MANUAL ADDRESSES THAT CAUTION IS NECESSARY WHEN USING ELECTROSURGERY IN CLOSE PROXIMITY OR DIRECT CONTACT WITH METAL. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONFIDENTIALIT ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS.
INFO RECEIVED ON 11/5/96 INDICATES INFECTION ALSO AT CYLINDERS.
THIS PHACOEMULSIFICATION HANDPIECE EXHIBITS UNSTABLE POWER DURING PROCEDURES.
TO DATE, NO PRODUCT HAS BEEN RECEIVED FOR EVALUATION. WHEN PRODUCT IS RECEIVED AND EVALUATED, RESULTS WILL BE FORWARDED.
AFTER A DIRECTIONAL CORONARY ATHERECTOMY (DCA) PROCEDURE WHILE THE PHYSICIAN WAS PREPARING FOR POST-STENT DEPLOYMENT, THE TIP OF THE GUIDEWIRE WAS NOTED IN A BRANCH OFF THE PT'S LEFT ANTERIOR DESCENDING ARTERY. THE PT WAS REPORTED TO BE UNAFFECTED BY THE DETACHED TIP DUE TO AN ALREADY EXISTING BYPASS GRAFT. THE PT IS REPORTED AS FINE.
ANALYSIS OF THIS GUIDE WIRE UNDER SCANNING ELECTRON MICROSCOPY CONCLUDED THAT THE SHAPING RIBBON HAD FRACTURED AS A RESULT OF A REVERSE BENDING FATIGUE. ENGINEERING CONCLUDED THAT THE SHAPING RIBBON SHOWED EVIDENCE OF TORSIONAL LOADING THAT EXCEEDED THE DESIGNED STRENGTH OF THE DEVICE. QUALITY ENGINEERING HAS DETERMINED THAT THIS IS A LOW LEVEL FAILURE MODE AND WILL CONTINUE TO MONITOR FOR THIS TYPE OF PRODUCT ISSUE. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPARTMENT.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORT #720744.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS COMPLETED, AND FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
DEVICE WAS IMPLANTED ON 10/10/86. THE CYLINDERS WERE REVISED ON 5/8/90. THE PUMP AND RESERVOIR WERE REVISED ON 12/9/91. THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS ON 9/13/96. ANOTHER DEVICE WAS IMPLANTED.
PUMP PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL.
ON 9/10/96 PT BEING SUPPORTED ON DEVICE. CONSOLE BEGAN TO SHOW SIGNS OF AN AIR LEAK IN PNEUMATIC SYSTEM. EXTERNAL COMPONENTS WERE CHANGED OUT. WITH NO IMPROVEMENT IN PUMP FUNCTION AND WITH EVENTFUL LOSS OF CONSOLE DISPLAY, THE DECISION WAS MADE TO RETURN PT TO THE O.R. FOR EXPLORATION OF ABDOMEN/CHEST TO EVALUATE PUMP IN SITU. AIR LEAK WAS IDENTIFIED AT JUNCTION OF TITANIUM PUMP AND PNEUMONIC DRIVE LINE. PUMP WAS REMOVED AND REPLACED. PT ONGOING.
X-TUBE ASSEM 18" X 16". DEALER CLAIMS. BROKEN AT THE BOLT HOLE.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED. ANALYSIS SHOWS THAT THIS CALIBRATION CODE, IF USED TO PERFORM AN ASSAY WITH TEST STRIPS FROM ANY LOT, COULD RESULT IN HIGHER THAN EXPECTED VALUES.
IT IS REPORTED TO CO THAT WHILE BEING SUPPORTED BY A LVAS, THE PT EXPERIENCED SYMPTOMS OF AN AIR LEAK IN THE SYSTEM. THE PT WAS TAKEN TO THE OR WHERE A DEATCHMENT OF THE PERCUTANEOUS LEAD WAS FOUND. THE PT WAS RE-IMPLANTED WITH A SIMILAR DEVICE. G 4 09 96 96.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
PUMP PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL. TUBING HAD A COMPRESSION SET LEAK.
AN IMPLANT FAILED PROBABLE DUE TO PERIODONTAL INFECTION.
NO OBSERABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DR'S OFFICE.
ALLEGED SEROMA. FOLLOW-UP FINDINGS: AS PER HEALTH PROFESSIONAL ETIOLOGY OF SEROMA UNK.
AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARULY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF CO'S EVALUATION OF THE DEVICE. EVALUATION OF THE DEVICE NOTED IT TO BE INTACT AND FUNCTIONAL. THE ALLEGED EVENT OF SEROMA IS NOT INDICATIVE OF A DEVICE FAILURE AND IS A KNOWN PHYSIOLOGICAL AND SURGICAL COMPLICATION.
WHEN DRAIN WAS REMOVED, DISTAL PORTION SEPARATED AND WAS RETAINED IN PT REQUIRING SURGUCAL REMOVAL.
MEDICS WERE TREATING A PT (AGE AND GENDER UNKNOWN) AND A "STATUS 51" MESSAGE APPEARED ON THE UNIT'S MONITOR SCREEN. THE MEDICS OBTAINED ANOTHER UNIT MFR AND CONTINUED ANOTHER UNIT AND CONTINUED TREATING THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT.
X-TUBE ASSM 16" X 16". DELAER CLAIMS THE X-TUBE IS BROKEN AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DISTRIBUTOR RETURNED A FAILED IMPLANT. HE NOTED BONE RESORPTION, PT IS SAME PT AS MEDWATCH REPORTS 2023141-1996-000149 AND 2023141-1996-000150.
SAMPLE WAS RETURNED & FORWARDED TO MFG. FACILITY ON 3/4/97. INVESTIGATION VERIFIED SEPARATION OF BOTH ENDS OF DRA IN. SILICONE CONNECTING TUBE WAS DETACHED FROM HUB OF DRAIN AS A RESULT OF A LACK OF SOLVENT. AN APPROX. 5 INCH SECTION OF DRAIN APPEARED TO HAVE BEEN SEVERED FROM END OF DRAIN & WAS NOT RETURNED FOR EVAL. FOLLOW-UP W/REPORTER ON 3/26/97 DID NOT REVEAL ANY INFO ABOUT MISSING SECTION. CATALOG # WAS IDENTIFIED AS REPORTED IN D.6 BASELINE INFO PREV. FILED FOR THIS NUMB.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO A HOLE IN CYLINDER WHERE CYLINDER WALL ATTACHES AT PROXIMAL BASE.
DISTRIBUTOR RETURNED A FAILED IMPLANT. HE NOTED BONE RESORPTION. PT IS SAME PT AS MEDWATCH REPORTS 2023141-1996-00149 AND 2023141-1996-00151.
DR REPORTED BROKEN ABUTMENTS DUE TO STRESSES OF SCUBA DIVING. AT FIRST THIS WAS THOUGHT TO BE AN UNAFFECTED  PART OF A BROKEN ABUTMENT. DURING INSPECTION IT WAS FOUND TO BE BROKEN IN THE GINGIVAL CUFF AREA. PT IS REPORTED TO BE IN EXCELLENT HEALTH.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. ACCURATE MEASUREMENTS COULD NOT BE TAKEN DUE TO THE DAMAGED CONDITION OF THE COMPONENT. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DR'S OFFICE.
CLINICIAN REPORTS LOSS OF INTEGRATION OF TWO ENDOSSEOUS DENTAL IMPLANTS. IMPLANTS HAD BEEN PLACED IN SITES 29 AND 30 IN CLASS II BONE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. REPORTEDLY, THE END OF THE CANNULA SNAPPED OFF IN THE MUSCLE LAYER OF THE PT'S ABDOMEN. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/24/96 MEDWATCH REPORT NOT REC'D BY MFR. SUBMITTED INITIAL REPORT.
DISTRIBUTOR RETURNED A FAILED IMPLANT. HE NOTED BONE RESORPTION. PT IS SAME PT AS MEDWATCH REPORTS 2023141-1996-00150.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. ACCORDING TO THE CLINICIAN 2 IMPLANTS WERE PLACED IN SITES 29 AND 31 IN CLASS IV BONE DURING A COMPLEX PROCEDURE ENTAILING BONE AUGMENTATION WITH FREEZE-DRIED BONE IN CONJUNCTION WITH RESORBABLE MEMBRANE. THE CLINICIAN REPORTS THAT BONE RESORPTION OCCURRED AROUND THE IMPLANTS AND THE IMPLANTS WERE REMOVED APPROX 7 MONTHS POST-OPERATIVELY.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN, THE IMPLANT WAS REMOVED APPROX FOUR MONTHS POST-OPERATIVELY DUE TO NON-INTEGRATION.
AN ABUTMENT BROKE WHILE HE WAS REPLACING IT. DR HAD REMOVED IT TO TAKE AN IMPRESSION. PT IS REPORTEDLY FINE.
THE DEVICE WAS USED DURING A HYSTERECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT HOLD. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/3/96 MEDWATCH REPORT NOT REC'D BY MFR. SUBMITTED INITIAL REPORT.
DR RETURNED A FAILED IMPLANT WITH LITTLE INFO.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT DUE TO LOSS OF INTEGRATION. IMPLANT WAS PLACED IN SITE #21 IN CLASS II BONE IN ROUTINE SURGERY. IMPLANT HAD NOT YET BEEN RESTORED.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS IMPLANTS IS BELOW THE EXPECTED FAILRUE RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
X-TUBE ASSM 16" X 17". DEALER ALLEGES X-TUBE IS BROKEN.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFELECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. ACCORDING TO THE CLINICIAN 6 IMPLANTS WERE PALCED IN CLASS II BONE CLOSE TO THE MAXILLARY SINUS DURING A HIGHLY COMPLEX PROCEDURE. THE CLINICIAN REPORTS THAT ATHE IMPLANTS IN SITE NUMBERS 5, 6, AND 12 DID NOT INTEGRATE AND WERE REMOVED. ACCORDING TO THE CLINICIAN THE REMAINING 3 IMPLANTS ARE STABLE.
THE DEVICE WAS USED DURING A HYPOSPADIAS REPAIR. THE SURGEON REPORTED THE NEEDLE BROKE DURING A RUNNING SUTURE. NO PT INJURY WAS REPORTED.
10/1/96-MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. ACCORDING TO THE CLINICIAN 5 IMPLANTS WERE PLACED DURING A ROUTINE PROCEDURE IN CLASS II BONE. THE CLINICIAN REPORTS THAT 2 OF THE IMPLANTS DID NOT INTEGRATE AND WERE REMOVED APPROX 2 1/2 MONTHS POST-OPERATIVELY. ACCORDING TO THE CLINICAL THE REMAINING 3 IMPLANTS ARE STABLE.
CO HAS REQUESTED ADD'L INFO. INFO ACQUIRED ON 10/21/96 INDICATES REASON AS EROSION.
LOSS OF INTEGRATION OF TWO ENDOSSEOUS DENTAL IMPLANTS. ACCORDING TO THE CLINICIAN 2 IMPLANTS WERE PLACED IN SITE NUMBERS 19 AND 21 DURING A ROUTINE PROCEDURE IN CLASS III BONE. THE CLINICIAN REPORTS THAT THE IMPLANTS BECAME MOBIL4E AND WERE REMOVED APPROX 1 MO POST-OPERATIVELY.
MFR'S DEVICE EVALUAITON TO FOLLOW. AN ADD'L INFO REPORT WILL BE FILED AT THAT TIME. PLEASE NOTE THAT THIS REPORT COVERS TWO ENDOSSEOUS DENTAL IMPLANTS (ONE PT). ATTACHED IS INFO ON THE SECOND IMPLANT.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN, SIX IMPLANTS WERE REPLACED IN CLASS III BONE DURING A HIGHLY COMPLEX PROCEDURE ENTAILING A SINUS GRAFT. THE CLINICIAN REPORTS THAT INFECTION DEVELOPED AROUND THE IMPLANT IN SITE #6 AND THAT  IMPLANT WAS REMOVED APPROX 5 MONTHS POST OPERATIVELY. ACCORDING TO THE CLINICIAN THE REMAINING 5 IMPLANTS ARE STABLE.
CO HAS REQUESTED ADDITIONAL INFORMATION. INFORMATION RECEIVED ON 11/18/96 INDICATES REASON AS FLUID LOSS-TUBING.
CODE: 86 EVALUATION OF COMPLAINT BASED ON MFG AND QC PROCEDURE, HISTORY OF DEVICE AND CONTENT OF EVENT DESCRIPTION. THIS INFO WAS RECEIVED BY A CO'S CLIN. ED. AS A CUSTOMER COMPLAINT. PRODUCT WAS USED SUCCESSFULLY FOLLOWING A DIAGNOSTIC PROCEDUE. SOME TIME LATER, THE PT PRESENTED WITH AN INFECTION. PT WAS HOSPITALIZED 9/3/-9/9 FOR ANTIBIOTIC TREATMENT. CODE: 68 PRODUCT IS ASSUMED STERILE. ATTRIBUTE INFECTION TO INADVERTENT CONTAMINATION.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS COULD NOT BE LOADED AFTER THE INSTRUMENT WAS FIRED TWICE. THE SURGEON USED ANOTHER INSTRUMENT.
10/1/96 MEDWATCH REPORT NOT REC'D BY MFR. SUBMITTED INITIAL REPORT. CO'S FOREIGN SUBSIDIARY WAS INFORMED OF THIS EVENT 7/27/96, HOWEVER CORPORATE WAS NOT INFORMED UNTIL SEPT 25, 1996. CO WILL TAKE ACTION TO REINSTRUCT THE APPROPRIATE PERSONNEL WITH REGARD TO THE STATUTORY REPORTING REQUIREMENTS OF THE MDR REGULATION.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. ACCORDING TO THE CLINICIAN 6 IMPLANTS WERE REPLACED. THE CLINICIAN REPORTS THAT THE IMPLANTS WERE INAPPROPRIATELY LOADED WITH AN INCORRECTLY PLACED TEMPORARY RESTORATION.
DURING A FEMORAL ANGIOPLASTY PROCEDURE ON A GREYHOUND, THE CATHETER BALLOON BURST AT 9-10 ATM. THE CATHETER WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS BEING REPORTED.
THIS INFO DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS LIKELY TO IF THE EVENT WERE TO RECUR. BLOCK H6, METHOD CODE 86, CHOSEN BECAUSE THERE WAS NO METHOD POSSIBLE TO PERFORM AN EVALUATION DUE TO THE SUSPECT DEVICE BEING DISCARDED BY THE USER FACILITY.
DEVICE WAS IMPLANTED ON 5/15/87. THE PUMP WAS REVISED ON 5/5/88. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 9/5/96 DUE TO INFECTION. ANOTHER DEVICE WAS IMPLANTED.
CODE 86: EVALUATION OF COMPLAINT BASED ON MFG AND QC PROCEDURES, HISTORY OF DEVICE AND CONTENT OF EVENT DESCRIPTION. THIS INFO WAS RECEIVED BY A CO CLIN. ED. AS CUSTOMER COMPLAINT. PRODUCT WAS USED SUCCESSFULLY FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE. APPROX 10 DAYS LATER, PT PRESENTED WITH A GROIN INFECTION. I&D WAS DONE AND CO COLLAGEN REMOVED. CODE 68: PRODUCT IS ASSUMED STERILE. ATTRIBUTE INFECTION TO INADVERTENT CONTAMINATION.
DEVICE WAS NOT CLINICALLY APPLIED. REPORTEDLY, THE INSTRUMENT BROKE PRIOR TO USE.
10/31/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
A PT PRESENTED WITH MOBILE IMPLANT, PAIN, AND EXUDATE, TOOTH AREA #3, TWO UNIT IMPLANT SUPPORTED BRIDGE.  PT IS REPORTEDLY FINE.  PT IS SAME PT AS MEDWATCH REPORT #2023111-1996-121.
DISTRIBUTOR RETURNED A BROKEN PART WITHOUT INFORMATION.
NO INFORMATION REGARDING PATIENT WAS GIVEN. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.'S OFFICE.
THE INFO CONTAINED HERIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES.
THE DR WENT TO ADJUST THE LIGHT. THE LIGHT THEN FELL, HITTING THE PT ON THE HEAD.
PT WAS USING AN OXYGEN CONCENTRATOR WHEN HE AWOKE TO A "BALL OF FLAME" AND RECEIVED 1ST DEGREE BURNS ON HIS FACE AND LEFT HAND.
LAB EVALUATED EQUIPMENT. EQUIPMENT FUNCITONED PROPERLY.
X-TUBE ASSM 18" X 16". DEALER CLAIMS: THE CROSS TUBE IS BENT AND CRACKED NOT SURE IF IT IS DUE TO THE PRESSURE OR WEIGHT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO THE CLINICIAN, 1 IMPLANT WAS PLACED IN SITE NUMBER 5 DURING A ROUTINE PROCEDURE IN CLASS II BONE. THE CLINICIAN REPORTS THAT THE IMPLANT WAS LOOSE APPROX 4 MONTHS      POSTOPERATIVELY AND WAS REMOVED.
ON 6/18/96, THE HCG RAPID PREGNANCY TEST GAVE A NEGATIVE RESULT ON A PT SERUM SAMPLE. THE PT WAS PLACED ON ORAL CONTRACEPTIVES WHEN THE NEGATIVE RESULT WAS REPORTED. AN ULTRASOUND WAS DONE A FEW DAYS PRIOR TO 8/28/96, SPECIFIC DATE UNKNOWN, WHICH INDICATED THE PT WAS 12-14 WEEKS PREGNANT WITH TWINS. IT WAS DETERMINED THAT THE PT WAS APPROX 1 MONTH PREGNANT AT THE TIME OF THE INITIAL TESTING PER ULTRASOUND. THE PT IS KNOWN TO HAVE IRREGULAR MENSES AND THE DATE OF LAST MENSES IS UNKNOWN. THE SERUM SAMPLE FROM 6/18/96 IS NOT AVAILABLE FOR RETURN. NO REPORT OF INJURY.
DURING A RIGHT HEMICOLECTOMY PROCEDURE, THE SUTURE BROKE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
SHUNT MALFUNCTON (PROXIMAL). HISTORY OF HYDROCEPHALUS. ADMITTED FOR SHUNT REVISION AFTER FOUR DAYS OF INCREASED LETHARGY. PT HAD HIGH PRESSURE CSF WITH LEAK AROUND OLD SHUNT TUBING. PT HAD LEFT OCCIPITAL VP SHUNT PLACED AT THREE DAYS OF AGE.
DURING AN ANGIOPLASTY PROCDURE, THE CATHETER BALLOON WOULD NOT INFLATE. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
THE EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IFTHE EVENT WERE TO RECUR.
DURING A PTCA/STENT PROCEDURE, THE BALLOON RUPTURED. THE GUIDWIRE FRACTURED DURING THE BALLOON BURST AND BEACME IMBEDDED BETWEEN THE STENT THE SAPHENOUS VEIN GRAFT WALL. THE GUIDEWIRE FRAGMENT COULD NOT BE REMOVED. THE STENT DEPLOYMENT WAS REPORTED TO BE SUCCESSFUL.
INVESTIGATION OF THE RETURNED DEVICE REVEALED LOSS OF CORE INTEGRITY. ANALYSIS OF THIS GUIDE WIRE UNDER SCANNING ELECTRON MICROSCOPY CONCLUDED THAT THE DEVICE FAILED AS A RESULT OF A FATIGUE FRACTURE. ENGINEERING CONCLUDED THAT THE FATIGUE CRACK EXTENDED THROUGH APPROX 40% OF THE CROSS SECTION OF THE DEVICE BEFORE TENSILE OVERLOAD CAUSED FAILURE. THE TENSILE OVERLOAD TOOK APPROX 1 LB. OF TENSION TO CAUSE THE WIRE TO FRACTURE. QUALITY ENGINEERING HAS DETERMINED THAT THIS IS A LOW LEVEL FAILURE MODE AN WILL CONTINUE TO MONITOR FOR THIS TYPE OF PRODUCT ISSUE. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPARTMENT.
PRODUCT WAS IMPLANTED AT UMC (BAPTIST MEDICAL CENTER) IN JACKSON, MISSISSIPPI ON 7/7/95 IN 2-3 DAY OLD PREMATURE INFANT AND REVISED ON 8/20/96. PT WAS ADMITTED FOR SHUNT REVISION AFTER FOURTH DAY OF INCREASED LETHARGY. PT HAD HIGH PRESSURE CSF AND LEAKAGE AROUND OLD SHUNT TUBING. CT SHOWED MIGRATIONAL ABNORMALITY.
CORRECTION: PRODUCT NOT AVAILABLE FOR EVAL. SINCE THE PRODUCT WAS NOT RETURNED, CO UNABLE TO CONFIRM OR CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED COMPLAINT. THE MFG RECORDS FOR THE PRODUCT COULD NOT BE REVIEWED AS NO LOT NUMBER WAS AVAILBLE.
NO INFORMATION REGARDING PATIENT WAS GIVEN.NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR'S OFFICE.
A PRESENTED WITH MOBILE IMPLANT, PAIN AND EXUDATE TOOTH AREA #4, TWO UNIT IMPLANT SUPPORTED BRIDGE. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-120.
DURING INSPECTION IT WAS NOTED THAT THE PART NUMBER IS 0804, NOT 0803 AS ORIGINALLY REPORTED. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR.
THE LENS WAS IMPLANTED ON 8/16/96. THE PHYSICIAN EXPLANTED THE LENS ON 9/10/96; THE REPORTING PHYSICIAN INDICATED THAT THE "HAPTICS WERE DEFECTIVE." AN ALTERNATIVE LENS WAS IMPLANTED.
WHEN THE LENS WAS RETURNED IT WAS OBSERVED THAT ONE OF THE HAPTICS WAS BENT AND CRACKED. AS THE IOL WAS HANDLED THE HAPTIC BROKE OFF COMPLETELY. IT IS NOT POSSIBLE TO DETERMINE WHETHER THE DAMAGE TO THE LENS WAS PRESENT AT IMPLANTATION, OR OCCURRED DURING EXPLANTATION. THE DIMENSIONS OF RTHE IOL WERE WITHIN SPECIFICATION.
DEVICE WAS ADVANCED AROUND THE BIFURCATION DURING A CONTRALATERAL STUDY. UPON WITHDRAWAL OF THE CATHETER, THE TIP CAUGHT ON CALCIFICATION AT THE BIFURCATION AND SEPARATED. DURING ATTEMPTED RETRIEVAL, THE TIP SEPARATED EACH TIME IT WAS SNARLED. HOWEVER, SEPARATED SEGMENTS WERE SUCCESSFULLY RETRIEVED.
F2.NOT PROVIDED BY THE HOSPITAL. THE RETURNED CATHETERS APPEAR TO HAVE BEEN MFR ACCORDING TO SPECIFICATIONS. HOWEVER, CO CONFIRMS THAT THE TIP HAS SEPARATED ON THE RETURNED USED CATHETER. UNFORTUNATELY, CO IS UNABLE TO DETERMINE WHY THIS EVENT MAY HAVE OCCURRED. ON 9/24/96, CO INITIATED A VOLUNTARY RECALL OF THIS PRODUCT DUE TO PREVIOUSLY RECEIVED REPORTS OF THE CATHETER TIP SEPARATION DURING USE.
DURING PTCA, THE BALLON WAS INFLATED TO 8 ATMS FOR 1 MINUTE. DEFLATION OF THE BALLOON WAS ATTEMPTED BUT THE DEVICE WOULD NOT DEFLATE THE BALLOON. A SYRINGE WAS ATTACHED TO SUCCESSFULLY DEFLATE THE BALLOON. A SECOND WAS ATTACHED AND THE PROCEDURE WAS COMPLETED. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT.
THE DEVICE WAS APPLIED DURING A BLADDER SUSPENSION. THE NEEDLE BROKE WHILE PASSING THROUGH TISSUE. THE SURGEON RETRIEVED THE COMPONENT WITHOUT PT INJURY. A NEW DEVICE WAS APPLIED TO COMPLETE THE PROCEDURE.
10/3/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
DEALER ALLEGES THE CASTER HINGE IS BROKEN.
INSUFFICIENT THREAD ENGAGEMENT. HIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
NO INFORMATION REGARDING THE PATIENT WAS GIVEN. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.'S OFFICE.
THE DEVICE WAS BEING UTILIZED FOR A CEREBRAL ARTERIOGRAM. UPON COMPLETION OF THE STUDY, THE CATHETER REMAINED FORMED AS IT WAS BEING WITHDRAWN FROM THE SELECTIVE VESSEL. A .035 WIRE GUIDE WAS ADVANCED AND THE CATHETER WITHDRAWN. UPON REMOVAL, IT WAS NOTED THAT THE CATHETER TIP HAD SEPARATED. UNDER FLUORO THE TIP WAS NOTED TO BE IN THE INTERNAL ARTERY. NO ATTEMPT WAS MADE TO RETRIEVE THE TIP.
A. 1,3) INFO WAS NOT AVAILABLE. F. 6,11) INFO WAS NOT AVAILABLE. H.6) OTHER-PRODUCT WAS NOT RETURNED TO ASSIST IN EVAL. NO PRODUCT WAS RETURNED FOR EVAL. HOWEVER, CO HAS SEEN TIP SEPARATION ON THIS PRODUCT IN THE PAST. CO HAS INITIATED A VOLUNTARY PRODUCT RECALL OF THIS PRODUCT LINE. CO IS CURRENTLY INVESTIGATING THIS MATTER.
DR REPORTED THAT HE TRIED TO TIGHTEN ABUTMENT AND THE THREAD THAT WAS IN THE IMPLANT SNAPPED OFF. PT IS REPORTEDLY FINE.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE STAPLES EJECTED FROM THE JAWS PREMATURELY. THE SURGEON COMPLETED THE PROCEUDRE WITH THE DEVICE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
CONSUMER WAS RUNNING TO CATCH A BALL WHEN HER LEFT LEG (THE LEG THAT HAD A BRACE ON IT) BUMPED INTO HER RIGHT LEG. THE FLEXION STOP PLATE ON THE MEDIAL HINGE CUT INTO THE RIGHT LEG AROUND THE MEDIAL CONDYLE, REQUIRING 15 STICHES TO CLOSE THE WOUND.
PRODUCT WAS ADJUSTED TO THE REQUIREMENTS SPECIFIED BY INNOVATION SPORTS, INC. REPAIR PERSONNEL TO ALLEVIATE THE CAUSE OF THE INJURY AND RETURNED TO CUSTOMER.
X-TUBE ASSM 16" X 15". DEALER CLAIMS: THE CROSS TUBE ASSEMBLY BROKE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBES THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE STENT/BALLOON CATHETER WAS ADVANCED TO THE PROXIMAL LAD. THE BALLOON WAS INFLATED TO EXPAND THE STENT. AFTER STENT EXPANSION, A DECISION WAS MADE TO DEFLATE THE BALLOON. HOWEVER, IT WOULD NOT DEFLATE. A 60CC SYRINGE WAS FINALLY UTILIZED TO DEFLATE THE BALLOON TO PULL THE BALLOON OUT.
A4. WEIGHT WAS NOT PROVIDED BY HOSP. F2. USER FACILITY NUMBER UNKNOWN. THE BALLOON CATHETER WAS RETURNED. PRODUCT WAS MFG ACCORDING TO SPECIFICATIONS. THE CATHETER WAS PARTIALLY DESTROYED DURING IN VITRO TESTING. INVESTIGATION REVEALED THAT THE DISTAL TIP LUMEN WAS CLEAR, HOWEVER, THE BALLOON/STENT LUMEN WAS PARTIALLY OCCLUDED. IN VITRO TESTING REVEALED THAT AFTER THE OCCLUSION WAS REMOVED, THE BALLOON BOTH INFLATED AND DEFLATED WITH EASE. BASED ON THE INFO PROVIDED, CO IS UNSURE AS TO WHY THE CUSTOMER EXPERIENCED ANY DIFFICULTIES. THE BALLOONS ARE INFLATED/DEFLATED TESTED 100% BY STENT QUALITY CONTROL PRIOR TO SHIPMENT.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE INSTRUMENT EJECTED CLIPS PREMATURELY. THE CLIPS WERE RETRIEVED LAPAROSCOPICALLY WITHOUT PT INJURY.
INITIAL IMPLANT 10/20/95. INFECTED GRAFT REMOVED 8/29/96.
X-TUBE ASSM 17 X 18". DEALER CLAIMS: X-TUBE BROKEN.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A RIGHT HEMICOLECTOMY PROCEDURE. THE SUTURE BROKE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
DISTRIBUTOR RETURNED BROKEN PART W/OUT INFORMATION.
DISTRIBUTOR ACTUALLY RETURNED SEVEN BROKEN PARTS, NOT ONE AS ORIGINALLY REPORTED. NO INFORMATION REGARDING PATIENT WAS GIVEN. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENTS THEMSELVES. DUE TO THE CONDITION OF THE PRODUCT ACCURATE MEASUREMENTS COULD NOT BE TAKEN. A REVIEW OF THE PRODUCT'S OF HISTORIES COULD NOT BE COMPELTED SINCE THE LOT NUMBERS WERE UNAVAILABLE FROM THE DOCTOR'S OFFICE.
F 10. 1930 - LABELED 2320 - LABELED. 2323 - NO CONCLUSIVE EVIDENCE OF FAILURE. REPLACE WITH 2320. H 3. EVALUATION IN PROCESS, ANALYSIS WILL BE PROVIDED IN A SUPPLEMENT.
IMPLANT DURATION: ~ 11 MONTHS. SITE: ABDOMINAL WALL. REASON FOR IMPLANTATION: ABDOMINAL INCISIONAL HERNIA. REASON FOR REMOVAL: INFECTION. GROSS. SPECIMEN CONSISTS OF A CIRCULAR, WHITISH, OPAQUE BIOMATERIAL MEASURING 4 X 4.5 CM. NUMEROUS, GREEN SUTURES ARE OBSERVED ALONG EDGES OF BIOMATERIAL. TWO LARGE BLUE SUTURES WITH MULTIPLE THROWS ARE OBSERVED IN ONE REGION AMONG GREEN SUTURES. THERE IS NO TISSUE ATTACHMENT TO EITHER SURFACES OF BIOMATERIAL. BROWNISH MOTTLED REGIONS ARE OBSERVED ALONG ONE SURFACE, TOWARD EDGE OF GREEN SUTURES. A FEW YELLOWISH REGIONS MEASURING 0.3 CM IN DIAMETER ARE OBSERVED. THREE FRAGMENTS OF SKIN AND SUBCUTANEOUS AND ADIPOSE TISSUE ARE INCLUDED WITHIN SPECIMEN CONTAINER. AN INDENTATION IS OBSERVED WITHIN SOFT TISSUE OF SKIN, CORESPONDING TO UMBILICUS. FOUR SECTIONS OF SPECIMEN ARE SUBMITTED FOR HISTOLOGICAL ANALYSIS. FIRST FOUR SECTIONS ARE TAKEN FROM BIOMATERIAL AND INCLUDE ARE OF YELLOWISH DISCOLORATION. FIFTH SECTION IS A SUTURE WITH NUMEROUS SUTURE THROWS. SIXTH, SEVENTH AND EIGHTH SECTION ARE OF SKIN TISSUE AROUND UMBILICUS REGION. MICROSCOPIC. DUALMESH BIOMATERIAL IS INFECTED WITH GRAM-POSITIVE BACTERIA. GRAM-POSITIVE BACTERIA ARE APPARENT AMONG NECROTIC DEBRIS AT SUTURE SITES, WHERE NECROTIC CELLULAR EXUDATE IS OBSERVED. FURTHER GRAM-POSITIVE BACTERIA ARE ALSO OBSERVED BETWEEN FILAMENTS OF MULTIFILAMENTED SUTURE. THERE IS NO TISSUE ATTACHMENT TO DUALMESH BIOMATERIAL. BACTERIA AE SCATTERED THROUGHOUT INTERSTICES OF IMPLANT. BACTERIA ARE ALSO FOUND IN NECROTIC CELLUAR EXUDATE ALONG EXTERNAL SURFACE. A NEUTROPHILIC INFILTRATE IS OBSERVED IN THESE REGIONS. A FRAGMENT OF UNBILICUS TISSUE SHOWS A NORMAL SQUAMOUS EPITHELIUM. HOWEVER, SCATTERED WITHIN DENSE FIBROUS TISSUE AND INTO DEEP SUBCATANEOUS TISSUE ARE FOCAL INFLITRATES OF LYMPHOCYTES AND PLASMA CELLS. NEUTROPHILIC INFILTRATES ARE OBSERVED AT REGION WHERE SOFT TISSUE HAS BEEN EXCISED. A FISTULA IS OBSERVED ALONG ONE REGION OF UMBILICUS. EPITHELIAL EROSION WITH DEGENERATION OF SUBCUTANEOUS TISSUE IS FOUND IN THIS REGION. WALLS ARE LINED BY CHRONIC INFLAMMATORY INFILTRATE CONSITING OF LYMPHOCYTES AND PLASMA CELLS. EDEMA AND NEUTROPHILS WITH OCCASIONAL NECROTIC CELLUAR DEBRIS IS OBSERVED WIHIN DEEP SUBCUTANEOUS TISSUE IN THIS REGION. BACTERIA ARE NOT OBSERVED WITHIN THIS SOFT TISSUE. THERE IS NO EVIDENCE OF CALCIFICATION. IMPRESSION. DUAL/MESH BIOMATERIAL SHOWS WIDESPREAD INFECTION WITH GRAM-POSITIVE BACTERIA. BACTERIA ARE OBSERVED WITHIN INTERSTICES AS WELL AS AT SUTURE SITE AND NECROTIC CELLULAR EXUDATE AROUND SUTURE. FURTHER BACTERIA ARE ALSO OBSERVED BETWEEN FILAMENTS OF MULTIFILAMENTED SUTURE. SOFT TISSUE AROUND UMBILICUS SHOWS A FISTULA WITH A FOCAL REGION OF EPITHELIAL EROSION. WALLS OF FISTUAL ARE LINED BY A CHRONIC PLAMACYTIC AND LYMPHOCYTIC INFILTRATE. HOWEVER, BACTERIA ARE NOT OBSERVED WITHIN THIS SOFT TISSUE.
DURING A PTCA/STENT PROCEDURE IN THE PT'S RIGHT CORONARY ARTERY, THE BALLOON RUPTURED DURING THE SECOND INFLATION BETWEEN 16-19 ATMS INSIDE THE STENT. THE BALLOON STILL APPEARED INFLATED DESPITE THE RUPTURE. A SYRINGE WAS ATTACHED TO PULL NEGATIVE AND THE BALLOON PARTIALLY DEFLATED. AFTER SEVERAL MINUTES THE BALLOON FULLY DEFLATED TO SUCCESSFULLY REMOVE THE CATHETER FROM THE PT. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT.
THIS REPORT WAS INCORRECTLY SUBMITTED ON 10/2/96 AS A MALFUNCTION MDR INSTEAD OF A SERIOUS INJURY DUE TO THE ALTERNATIVE INTERVENTION THAT WAS PERFORMED.
IN AN ATTEMPT TO INSERT A PORT MULTIPLE ATTEMPTS WERE MADE USING CO INTRODUCER SETS. A PORTION OF THE GUIDEWIRE WAS IDENTIFIED BY X-RAY IN THE TISSUE OUTSIDE THE VEIN IN THE SUBCLAVIAN AREA. UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE GUIDEWIRE FROM THE TISSUE AREA. PHYSICIAN AND PT ELECTED TO LEAVE GUIDEWIRE IN TISSUE.
NO INFORMATION REGARDING PATIENT WAS GIVEN. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. DUE TO THE CONDITION OF THE PRODUCT ACCURATE MEASUREMENTS COULD NOT BE TAKEN. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.'S OFFICE.
A1. HOSPITAL DID NOT PROVIDE PT IDENTIFIER OR WEIGHT. D6. CATALOG # C-PLI-10.0-38 H6. OTHER -NO PRODUCT WAS RETURNED FOR OUR EVAL OR TESTING.
THE DEVICE WAS APPLIED DURING A HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT HOLD. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
X-TUBE ASSM 19" X 16". DEALER CLAIMS THE X-TUBE BROKE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT RELFECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DISTRIBUTOR RETURNED A BROKEN PART W/OUT INFORMATION.
DISTRIBUTOR ACTUALLY RETURNED SEVEN, NOT ONE AS ORIGINALLY REPORTED. NO PATIENT INFORMATION WAS GIVEN. NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENTS THEMSELVES. DUE TO THE CONDITION OF THE PRODUCTS ACCURATE MEASUREMENTS COULD NOT BE TAKEN. A REVIEW OF THE PRODUCT'S LOT HISTORIES COULD NOT BE COMPLETED SINCE THE LOT NUMBERS WERE UNAVAILABLE FROM THE DR.'S OFFICE.
PT IN CLINIC TO HAVE BLOODS DRAWN AND FLUSH OF PORT-A-CATH. RN ACCESS PORT WITH 196 HUBER NEEDLE, UNABLE TO ASPIRATE BLOOD, FLUSH 2-3CC NORMAL SALINE WITH SMALL AMOUNT OF RESISTANCE. PT HEARD A "POP", FELT A DISCOMFORT. RN NOTED RAISED AREA ABOUT 3 CM ABOVE SEPTUM SOFT, NONTENDER. CXR CONFIRMED KINK IN CATHETER BUT INTACT, CONTRAST INTERVENTIONAL STUDY DONE CONFIRMED LEAK IN CATHETER AT KINK SITE. PORT WAS REMOVED, NO NEGATIVE OUTCOME. CATHETER IS CRACKED ABOUT 6CM ABOVE SEPTUM.
DURING PTCA, THE BALLOON BURST AT 12 ATMS. THE PHYSICIAN INDICATED HE WAS STILL ABLE TO VIEW THE INFLATED BALLOON AFTER THE BALLOON BURST. SEVERAL ATTEMPTS WERE MADE TO PULL NEGATIVE ON THE BALLOON TO DEFLATE. THE BALLOON WAS REMOVED FROM THE PT, PARTIALLY INFLATED. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT. AFTER REMOVAL OF THE BALLOON CATHETER FROM THE PT, LAB PERSONNEL WAS ABLE TO STILL INFLATE THE BALLOON DESPITE THE BALLOON RUPTURE AT THE PROXIMAL SEGMENT.
EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION ON 9/15/96. ANALYSIS INDICATED THAT A LONGITUDINAL RUPTURE OF THE BALLOON HAD OCCURRED IN THE PROXIMAL AREA OF THE BALLOON. CO WAS UNABLE TO INFLATE THE BALLOON FOR DEFLATION TIMES DUE TO THE BALLOON RUPTURE. THE 12 ATMS OF PRESSURE USED DURING THE TIME OF THE BALLOON RUPTURE EXCEEDS THE RATED BURST PRESSURE OF 8ATMS. THE BALLOON RUPTURE WAS MOST LIKELY DUE TO THE HIGHER PRESSURE. ALL ELIPSE CATHETERS ARE INFLATED TO NOMINAL PRESSURE PRIOR TO PACKAGING. THE RESULTS OF THE TESTING FOR THIS LOT WERE WITHIN PRODUCT SPECIFICATIONS.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. A CLEAR, 10 FRENCH, 6 INCH HEMOSTASIS VALVE ASSEMBLY WAS RETURNED FOR EVALUATION WITH BLOOD NOTED ON THE INTERIOR AND EXTERIOR OF THE DEVICE. THE BLUE DILATOR WAS NOTED TO BE IN PLACE THROUGH THE VALVE. A KINK WAS NOTED IN THE SHEATH TUBING. VISUAL EXAMINATION REVEALED THAT THE HEMOSTASIS VALVE WAS SCREWED TO THE SHEATH'S YELLOW HUB. THE I.D. OF THE SHEATH WAS MEASURED AND FOUND TO BE WITHIN DATASCOPE'S MFG SPECIFICATIONS. A SHEATH/SHEATH HUB LEAK TEST WAS PERFORMED ON THE ASSEMBLY ACCORDING TO DATASCOPE'S MFG SPECIFICATIONS. NO LEAK WAS OBSERVED BETWEEN THE SHEATH TUBING AND THE SHEATH HUB OR BETWEEN THE CLEAR HEMOSTASIS VALVE AND THE SHEATH HUB. THE ASSEMBLY WAS VERIFIED TO BE WITHIN SPECIFICATION. USING A LABORATORY IAB, THE SHEATH/HEMOSTASIS VALVE ASSEMBLY WAS LEAK TESTED IN ORDER TO DETERMINE IF THE VALVE ASSEMBLY PASSED THIS LEAK TEST. WHEN THE HEMOSTASIS VALVE ASSEMBLY WAS TESTED WITH JUST A LABORATORY GUIDEWIRE IN PLACE THROUGH THE VALVE ASSEMBLY, LEAKAGE DID OCCUR BETWEEN THE VALVE GASKET AND THE GUIDEWIRE. A 60CC VACUUM WAS PULLED ON A LABORATORY FOLDED MEMBRANE USING A LABORATORY SYRINGE AND A ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH THE RETURNED SHEATH/HEMOSTASIS VALVE ASSEMLBY WITHOUT DIFFICULTY. PROBABLE CAUSE OF DIFFICULTY: LABORATORY EXAMINATION OF THE RETURNED IAB AND SHEATH/CLEAR HEMOSTASIS VALVE ASSEMBLY FOUND NO DEFECTS. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTY DURING LABORATORY EXAMINATION. DIFFICULTY ADVANCING THE IAB INTO THE SHEATH/HEMOSTASIS VALVE ASSEMBLY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: THE USER MAY HAVE NOT DRAWN A SUFFICIENT VACUUM ON THE BALLOON DURING ITS REMOVAL FROM THE BLISTER TRAY. IF DRAWN, A VACUUM MAY HAVE NOT BEEN MAINTAINED THROUGHOUT THE INSERTION PROCEDURE. DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. THE PATIENT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO THE SHEATH. DURING IAB INSERTION, THE BALLOON MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY AS IT EXITED THE END OF THE SHEATH. THE CATHETER AND/OR INNER LUMEN KINKED DURING INSERTION IF THE BALLOON WAS NOT SUPPORTED BY A GUIDEWIRE. THE CATHETER WAS HELD TOO FAR BACK FROM THE SITE OF INSERTION. IT WAS ORIGINALLY REPORTED THAT THE CLEAR HEMOSTASIS VALVE WAS UNSCREWED FROM THE SHEATH HUB WHICH CAUSED MORE BLEEDING THAN USUAL BUT WHEN THE DATASHEET WAS RETURNED, IT WAS REPORTED THAT THE VALVE WAS FOUND UNATTACHED TO THE SHEATH WITHIN THE BLISTER TRAY. THE VALVE WAS ATTACHED PRIOR TO USE. UNFORTUNATELY, IT IS NOT POSSIBLE TO DETERMINE WHEN THE CLEAR VALVE BECAME LOOSE FROM THE SHEATH HUB.
UPON OPENING THE INSERTION KIT ON 10/1/96, THE HEMOSTASIS VALVE WAS FOUND UNATTACHED TO THE SHEATH. THIS WAS REATTACHED BY THE SCRUB NURSE. ARTERIAL ACCESS WAS DIFFICULT DUE TO A PREVIOUS AORTA-BIFEMORAL GRAFT. AFTER GAINING ACCESS, A WIRE WAS PASSED, THEN A DILATOR, AND THEN A DILATOR WITH A SHEATH. THE BALLOON WAS PASSED OVER THE GUIDEWIRE, BUT THE HEMOSTASIS VALVE PREVENTED THE BALLOON CATHETER INSERTION. NUMEROUS ATTEMPTS TO PASS THE HEMOSTASIS VALVE WERE ATTEMPTED. AT THIS POINT, THE SURGEON BECAME FRUSTRATED AND REMOVED THE APPARENT DEFECTIVE SHEATH (VALVE). THE REMAINING PROCEDURE WAS UNEVENTFUL. THE PATIENT RESPONDED WELL TO IABP THERAPY ON 10/1/96. THE PATEINT WENT ON TO EXPIRE ON 10/4/96. EVENT COMPLICATIONS: UNK - REPORTED 10/4/96 AND 10/18/96. PATIENT'S CURRENT STATUS: EXPIRED 10/4 - RPT'D 10/8.
H3 - CATHETER RUPTURE OF UNKNOWN CAUSE. ACCORDING TO RPTR DIFFICULTY HAD BEEN PREVIOUSLY EXPERIENCED IN INFUSING AND ASPIRATING THE SYSTEM. 10 ML SYRINGE USED IN AN ATTEMPT TO CLEAR SYSTEM. IT IS UNKNOWN WHAT PRESSURE WAS GENERATED IN THE ATTEMPT TO CLEAR THE SYSTEM. BASELINE REPORT FOR THIS DEVICE FAMILY SUBMITTED WITH 2183502-1996-00001 DATED 8/27/96. THE PORTAL WAS RETURNED WITH AN UNATTACHED 7.5 INCH LENGTH OF CATHETER. MICROSCOPY EXAMINATION OF THE CATHETER REVEALED A 0.25 INCH SPLIT ALONG THE LENGTH OF THE CATHETER, 2.25 INCHES FROM THE PROXIMAL END OF THE CATHETER. THE ORIENTATION AND PHYSICAL CHARACTERISTICS OF THE SLIT ARE CONSISTENT WITH A MECHANICAL FAILURE OF UNKNOWN CAUSE.
DEALER ALLEGES THE STEM BROKE WHERE IT MEETS THE FORK.
FORK STEM. UNEVEN SIDE LOADING. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE BALLOON WAS SUCCESSFULLY USED.
PATIENT'S CURRENT STATUS: UNK - RPT'D 10/4/96.
DISTSRIBUTOR RETURNED A BROKEN PART WITHOUT INFORMATION.
IT WAS REPORTED THE EZ35B WAS USED DURING A DIAGNOSTIC LAPAROSCOPY WITH OOPHORECTOMY. THE JAWS WOULD NOT RELEASE AFTER FIRING. THE SURGEON PULLED THE HANDLE WHILE MANIPULATING THE JAWS WITH ANOTHER INSTRUMENT TO RELEASE IT FROM THE TISSUE. ANOTHER EZ35 WAS NOT OPENED TO COMPLETE THE CASE. THERE WAS NO BUTTRESSING MATERIAL USED. THERE WAS NO CONSEQUENCE TO THE PT.
G3: REPORT SOURCE; "FOREIGN" SHOULD HAVE NOT BEEN CHECKED OFF.
THE DEVICE WAS USED DURING A LAPAROSCOPIC ADJUSTABLE BAND. IT WAS REPORTER THAT WHEN "USING THE EXTRA LONG TROCAR IN AN OBESE PT THE TIPS OF THE TROCARS BROKE AND THE PIECES FELL INTO THE ABDOMINAL CAVITY. MOST PIECES COULD BE RETRIEVED. THE SHARP END OF THE BROKEN TROCAR RIFTED THE LIVER.
A1,2,3,4,B3,6,7,D10-INFO NOT PROVIDED BY AFFILIATE. H8-INFO NOT AVAILABLE. RESULTS OF EVALUATION: CONCLUSION: A,B) BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE TWO SLEEVES HAD BROKEN DISTALLY DURING SURGERY. NOT ALL OF THE BROKEN PIECES WERE RECEIVED WITH THE INSTRUMENTS. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. TWO T512 THREADED ADAPTORS WERE ALSO RECEIVED WITH THE INSTRUMENTS AND FOUND TO BE CONFORMING. APPROPRIATE ENGINEERING AND MFG PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.
CASTER HINGE L RV. DEALER CLAIMS CASTER HINGE HAS WORN OUT.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
(IAB S/N UNK) THE CLEAR HEMOSTASIS VALVE WAS UNSCREWED FROM THE 6" SHEATH AND BLEEDING WAS NOTED AT THE VALVE. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVALUATION. THE VALVE WAS DISCARDED BY THE FACILITY.
A SAFETY ALERT WAS ISSUED ON 10/1/96. A COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE. *THIS FORM WAS COMPLETED BY THE FACILITY*. IT WAS NOT DETERMINED UNTIL THE SAFETY ALERT LETTER WAS SIGNED ON 9/27/96 THAT THIS WAS A 5 DAY REPORTABLE MDR. ALL FUTURE SIMILAR COMPLAINTS WILL BE REPORTED WITHIN 5 WORKING DAYS.
IT WAS REPORTED THE DEVICE WAS USED DURING LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE ER320, FROM KIT FTR32, WAS SPITTING CLIPS FROM THE JAWS OF THE DEVICE. IT IS NOT KNOWN IF CLIPS FELL INTO PT AND REQUIRED RETRIEVAL. THERE WAS NO PT CONSEQUENCE.
H6; CODE 400: YIELDED JAWS. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
NO PATIENT INFORMATION WAS GIVEN.NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. DUE TO THE CONDITION OF THE PRODUCT ACCURATE MEASUREMENTS COULD NOT BE TAKEN. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.'S OFFICE.
FAILED TOTAL KNEE PROSTHESIS REQUIRED REPLACEMENT. MILD CREPITUS, SIGNIFICANT TRANSLATION OF KNEE JOINT ANTERIORLY, POSTERIORLY AS WELL AS MEDIALLY. PT STATES IN H&P "KNEE HAS ALWAYS BEEN LOOSE."
THE RIGHT HIP/ACETABULAR CUP LINER HAD TO BE REMOVED BECAUSE IT WAS "FAULTY". SURGEON STATES THAT FAILURE OF THE DESIGN/CONFIGURATION OF THIS PRODUCT IS KNOWN NATIONWIDE.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OF ITS AFFILIATES. D.6. THE CAT NUMBER GIVEN BY THE USER FACILITY OF THE DEVICE COMPONENT THAT ACTUALLY FAILED IS INCORRECT. THE EXACT SIZE AND LOT NUMBER OF THE FAILED COMPONENT IS UNKNOWN BECAUSE THE COMPLETE (CORRECT) CAT NUMBER WAS NOT PROVIDED TO CO.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE ER320 MISFIRED. THERE WAS NO PT CONSEQUENCE.
DISTRIBUTOR RETURNED A BROKEN ABUTMENT -UNABLE TO DETERMINE PART NUMBER DUE TO PLECES RETURNED.
DISTRIBUTOR RETURNED A BROKEN ABUTMENT - UNABLE TO DETERMINE PART NUMBER DUE TO PLECES RETURNED.
NO PATIENT INFORMATION WAS GIVEN. DURING INSPECTION THE PART NUMBER DETERMINED TO BE 0620.NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. DUE TO THE CONDITION OF THE PRODUCT ACCURATE MEASUREMENTS COULD NOT BE TAKEN. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.'S OFFICE.
EVALUATION RESULTS SUGGEST THAT THIS EVENT IS PATIENT RELATED. THE PATIENT SUFFERED AN ADVERSE REACTION TO THE PRODUCT. THIS ADVERSE REACTION IS WELL KNOWN AND DOCUMENTED WITHIN THE PRODUCT LITERATURE.
THE DEVICE WAS USED DURING AN OVARIAN TUMOR DEBULKING. A HOLE WAS DISCOVERED IN THE DRAPE DURING THE PROCEDURE. THE HOLE WAS VERY CLOSE TO WHERE THE BLADE WAS LYING. A BOVIE WAS ALSO ON THE FIELD, BUT IT IS UNK WHERE IT WAS AT THE TIME. IT WAS REPORTED THE SCRUB NURSE STATED AS SOON AS SHE SAW THE TIP HAD GONE THROUGH THE DRAPES, SHE CHECKED THE BLADE AND IT WAS WARM, NOT HOT. THE DRAPE WAS COVERED WITH A NEW STERILE DRAPE AND A NEW ONE WAS OPENED. AT THE COMPLETION OF THE CASE THE DRAPES WERE REMOVED AND A BURN WAS NOTICED; 7MM IN CIRCUMFERENCE, 5MM DEEP ON THE ANTERIOR THIGH. IT IS UNK WHICH THIGH WAS BURNED. A GROUNDING PAD WAS IN PACE ON THE THIGH, BUT NOT KNOWN WHICH THIGH.
THIS EVENT WAS REPORTED AS PULMONARY ATRESIA. NO FURTHER INFO PROVIDED.
DURING A HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT HOLD PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
A1,4;B6;D10: INFO UNAVAILABLE. D5,6;H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
AN ABUTMENT BROKEN IN FUNCTION. PT IS REPORTEDLY FINE.
IT WAS REPORTED THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED ON THE FIRST FIRING THE HANDLE BROKE AND THE ANVIL WOULD NOT RELEASE. THEY HAD TO RELEASE HEAD WITH OTHER TOOLS. THE INSTRUMENT DID NOT FIRE. THERE WAS NO CONSEQUENCE TO THE PT. NO BUTTERSSING MATERIAL WAS USED.
9/18/96 1050 THE SURGEON SAID HE STAPLED WITH THE ORIGINAL CARTRIDGE ACROSS THE BASE OF THE APPENDIX. THE DEVICE WAS RELOADING WITH A WHITE CARTRIDGE AND PLACED ACROSS THE MESOAPPENDIX. IT APPEARED TO CLAMP PROPERLY, BUT WHEN ATTEMPTING TO FIRE, THE HANDLE BROKE WITH A LOUD CRACK AND PART OF THE HANDLE FELL ON THE FLOOR. THE INSTRUMENT DID NOT CUT OR STAPLE. IT RELEASED FROM THE TISSUE AFTER "GIGGLING IT AROUND FOR A WHILE." THE TISSUE COULD BE PRYED OUT OF THE INSTRUMENT WITHOUT DAMAGE BECAUSE IT HAD NOT STAPLED. ANOTHER EZ35 WAS OPENED AND THE CASE COMPLETED. THERE WAS NO CONSEQUENCE TO THE PATIENT. A1,2,3,4,B6,7,D10-INFO NOT PROVIDED BY USER FACILITY. H4,D5-INFO NOT AVAILABLE. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. THE RETURNED CARTRIDGE HAD A BROKEN MIDDLE ALIGNMENT FINGER AND WAS MISSING THE LOCKOUT TAB. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
DURING A HYSTERECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON APPLIED SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
D5,6;H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. ON THE SAME DAY DURING A SEPARATE PROCEDURE PATIENT RECEIVED BILATERAL CHEST TUBES, FIBEROPTIC BRONCHOSCOPY WITH PLEURAL/MEDIASTINAL IRRIGATION. PATIENT IS 52 YR OLD MALE, DOB 10-9-43, MEDICAL RECORD #531425519. PATIENT WAS DISCHARGED ON 7-13-96 AND REPORTEDLY IS DOING OK NOW. UNK HX OF ILLNESS. STATED SHE WILL CALL BACK WITH AN ADDITIONAL INFO. TSB. 9/17/96 RECEIVED ADDITIONAL INFO-SEE SEPARATE PAGE. (BELOW)TSB 10-15-96. 10-15-96 IN THE POST OPERATIVE PERIOD THE PATIENT WAS REEXPLORED FOR 3 PERFORATIONS OF THE STOMACH, 2 OF THEM MEASURING 1CM AND 1 MEASURING 2CM LOCATED ON THE GREATER CURVATURE FOLLOWED THE USE OF THE HARMONIC SCALPEL ON A LAPROSCOPIC NISSEN PROCEDURE. THE PATIENT DEVELOPED SEVERE MEDIASTENITIS AND AFTER A PROLONGED PERIOD OF TIME, RECOVERED, DR. IS NOT CERTAIN WHETHER OTHER MODALITIES SUCH AS CAUTERY WERE USED DURING THE CASE. THERE IS NO VIDEO OR OTHER MATERIAL. DR. CONTINUES TO USE THE HARMONIC SCALPEL AND IS NOT CERTAIN WHETHER THIS WAS CAUSED BY AN INDIVIDUAL VARATION, USER ERROR OR AN INSTRUMENT PROBLEM.
9/16/96 1500 MARTY M. REPORTED ON 6/21/96 PATIENT UNDERWENT A LAPAROSCOPIC NISSEN FUNDOPLICATION AND WAS SENT HOME THE SAME DAY. ON 6/23/96 THE PATIENT WAS ADMITTED VIA ER AND ON 6/24/96 UNDERWENT THE FOLLOWING: EXPLORATORY LAPAROSCOPY, REPAIR OF PARAESOPHAGEL HIATAL HERNIA, REPAIR OF GASTRIC PERFORATION, FEEDING JEJUONOSTOMY.
IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP THE ER320 DOESN'T RELEASE THE CLOSED CLIP BUT AFTER SOME PROBLEMS IT WAS RELEASED. PHYSICIAN USED OTHER INSTRUMENT (SAME CODE) AND DID NOT HAVE PROBLEMS. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D10-INFO NOT PROVIDED BY THE AFFILIATE. H4-INFO NOT AVAILABLE. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED WITH A BENT SHAFT, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. NO CONCLUSION COULD BE REACHED AS TO HOW THE SHAFT HAD BECOME BENT. THE INSTRUMENT WAS CYCLED AND FED THE CLIP AS DESIGNED. THE CLIP FORM WAS WITHIN DESIGN SPECIFICATION. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED PROPERLY AND THAT THE CLIP FORM IS WITHIN DESIGN SPECIFICATION.
CO SHIPPED A LENS IMPLANT FOR A CATARACT PROCEDURE THAT WAS DIFFERENT THAN WHAT WAS ORDERED, DUE TO THE SIMILARITY OF PART NUMBERS. THE OR PERSONNEL AND SURGEON DID NOT NOTICE THE MISTAKE AND THE WRONG LENS WAS IMPLANTED. THE PT HAD TO RETURN TO SURGERY FOR REIMPLANTATION OF THE CORRECT LENS. P/N P366UV 17.0 WAS ORDERED. P/N P336UV 17.0 WAS SHIPPED. THE IMPLANT WAS PACKAGED AND LABELED CORRECTLY HOWEVER THE SIMILARITY IN PART NUMBERS FOR DIFFERENT LENSES MAY HAVE CONTRIBUTED TO THE INCIDENT.
PRODUCT DID NOT DISSOLVE AND HAD TO BE REMOVED FROM PT'S EYE. A CORNEAL ABRASION WAS OBSERVED AND TREATED WITH ANTIBIOTIC OINTMENT AND RESOLVED IN 5 DAYS. THE PRODUCT WAS USED AFTER AN UNCOMPLICATED CATARACT PROCEDURE AND WAS BAKED IN TOBRADEX PRIOR TO APPLICATION. HE REPORTS THE POTENTIAL FOR INJURY EXISTS IF THIS INCIDENT WERE TO RECUR.
THE RETURNED UNOPENED PRODUCTS WERE SUBJECTED TO IN-VITRO DISSOLUTION TESTING. DISSOLUTION TIMES WERE LONGER THAN PREVIOUSLY SEEN FOR THIS PRODUCT AGE. THE LONGER DISSOLUTION TIME IS BELIEVED TO BE RELATED TO MFG PROCESS CHANGES EARLY IN 1996. AS A RESULT OF THESE COMPLAINTS WE HAVE CHANGED BACK TO THE PREVIOUS PROCESS.
IT WAS REPORTED THE DEVICE WAS USED DURING A PREPERITONEAL HERNIA REPAIR. IT WAS REPORTED THE TED12 BALLOON BURST. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: INSTRUMENT WAS RECEIVED WITH A BURST BALLOON. THE INITIAL POINT OF DAMAGE APPEARED TO HAVE PROPAGATED AT THE DISTAL TIP.
RECEIVED MEDWATCH #1009717 ON 9/4/96 "CLIP APPLIER SHOT THE CLIPS OUT AND DID NOT CLOSE THEM-NO PINCHING/CLOSING ACTION AT ALL. NO INJURY TO PT. UNABLE TO RETURN DEFECTIVE DEVICE TO MFR AS IT HAD TO BE DISCHARGED."
DURING A HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT HOLD. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HSOP HAS REPORTED NO PT INJURY OCCURRED.
THE SOURCE ORIGINALLY REPORTED THAT THE PUMP WOULD NOT INFUSE AND BIOMED COULD NOT DUPLICATE. ADD'L INFO RECEIVED BY THE MFR AFTER THE PUMP HAD BEEN ANALYZED AND SERVICED: THE PUMP WAS ORIGINALLY PROGRAMMED TO DELIVER 24CC OF CISPLATIN OVER 24 HRS IN THE V/T MODE USING A 30CC SYRINGE. THE PT WAS ALSO RECEIVING BCNU AT A RATE OF 28CC OVER 5 MINUTES IN THE VT/T MODE USINGA 30CC SYRINGE EVERY SIX HR. THE CISPLATIN INFUSION WAS STOPPED DURING THE BCNU INFUSION AND THE SAME PUMP WAS USED. WHEN THE CISPLATIN WAS RESTARTED THE PUMP WOULD BE REPROGRAMMED FOR THE REMAINING VOLUME FOR THE 24 HR PERIOD. THE DAY SHIFT NURSE NOTICED THAT THE CISPLATIN SYRINGE HAD MORE FLUID IN IT THAN IS SHOULD HAVE. THE CLINICIANS FEEL THAT THE BCNU BACKFLOWED INTO THE CISPLATIN SYRINGE THAT WAS ATTACHED WITH TUBING THAT HAD NOT BEEN CLAMPED OFF. THEY DO NOT FEEL THAT THE PUMP MALFUNCTIONED.
THIS M.D.R. IS BEING FILED IN ORDER TO COMPLY WITH 21 CFR PART 803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT THE DEVICE ACTUALLY MALFUNCTIONED  OR CAUSED ANY INJURY. H3. THE HISTORY WAS DOWNLOADED AND FOUND TO BE INCONCLUSIVE.
DURING A HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT LOCK PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
WHILE LIFTING A HEAVY MALE PT THE HOIST TIPPED SIDEWAYS. THE RESIDENT WAS UNINJURED BUT BADLY SHAKEN. THE CUSTOMER SUSPECTS THAT THE LEG WAS NOT ENGAGED CORRECTLY. ONE PERSON INVOLVED, NO INJURY.
THE FOLLOWING IS THE CLOSING OUT REPORT OF THE FOREIGN REPORTER. INVESTIGATION: THE HOIST WAS CHECKED AND NO FAULT WAS FOUND. THE LOCKING BOLTS ON BOTH LEGS WERE IN GOOD CONDITION AS WERE THE SPRINGS. OBSERVATIONS: THE MATRON BELIEVES THE LOCKING BOLT MAY HAVE CAUGHT AND DISENGAGED (UNABLE TO PROVE). CONCLUSION: USER ERROR. CORRECTIVE ACTION: THE STAFF IS TO BE ADVISED TO CHECK LOCKED POSITION OF BOLT BEFORE USE.
QR AXLE MAG W/NUT. DEALER CLAIMS THE BALL BEARING THAT LATCH QR AXLE HAVE FALLEN OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A HERNIA PROCEDURE, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/3/96-MEDWATCH REORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT. THE DEVICE DISPLAYED DAMAGE CONSISTENT WITH OVEREXPOSURE TO HEAT. THE USER RESTERILIZED THE DEVICE.
IT WAS REPORTED THE TSF 10 WAS USED DURING A LAPAROSCOPIC LEFT SALPINGO OOPHORECTOMY. THE DEVICE WAS PLUGGED INTO THE BIPOLAR PORTION OF GENERATOR. THE FORCEPS CLASPED ON IP LIGAMENT AND PEDAL STEPPED ON. NO TISSUE AFFECT WITH THE DEVICE, IT WOULD NOT CAUTERIZE. AN TRIPOLAR WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
CO 964756. A1,02,3,4; B6, 7; D10 CONTACTED SURGEON. INFO NOT AVAILABLE. D5; H4,6 INFO NOT AVAILABLE AT THIS TIME. BASED UPON THE INQUIRY INFO REC'D THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. IF THE INSTRUMENT IS ELECTRICALLY ACTIVATED WHEN THE JAWS ARE LOCKED IN THE CLOSED POSITION, THE ELECTRICAL CURRENT MAY BYPASS THIN TISSUE. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE ITS PRODUCTS.
ACCORDING TO THE SOURCE, THE DEVICE IS NOT DELIVERING THE RIGHT VOLUME THAT WAS PROGRAMMED. NO FURTHER INFO IS AVAILABLE.
THIS M.D.R. IS BEING FILED IN ORDER TO COMPLY WITH 21 CFR PART 803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT THE DEVICE ACTUALLY MALFUNCTIONED OR CAUSED ANY INJURY. H3: THE ABOVE CODES ADEQUATELY DESCRIBE THE METHODS, RESULTS AND CONCLUSION. 68: NO REPAIR REQUIRED.
SIX IMPLANTS PLACED 2/1/96. ONE DID NOT INTEGRATE AND WAS REMOVED. ONE PERSON AFFECTED.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE A RESTORE 4X10 SELF-TAPPING IMPLANT, RATHER THAN THE REPORTED RESTORE 3.75X15 SELF-TAPPING IMPLANT. IT IS PROBABLE THAT THE PT'S HISTORY OF SMOKING CONTRIBUTED TO THE IMPLANT FAILURE.
PLEASE NOTE THAT CO IS UNABLE TO COMPLETE THE INVESTIGATION FOR THE INITIAL REPORT SUBMISSION. A FOLLOW UP RREPORT WILL BE SUBMITTED BY NOVEMBER 11, 1996.
A RETURN GOODS AUTHORIZATION WAS ISSUED FOR THE AFFECTED ASSEMBLY ON 9/16/96. HOWEVER, AS OF 10/7/96, NO CLAMPS WERE RETURNED FOR INVESTIGATION. THE FACILITY HAS NOT RETURN THE DEFECTIVE CLAMPS BECAUSE THEY HAVE NOT REPLACED THE CLAMP ASSEMBLIES ON THE MACHINES. ON 10/7/96, QUALITY ASSURANCE CONTACTED THE FACILITY AND STRONGLY ENCOURAGED THEM TO RETURN PARTS FOR INVESTIGATION. THE FACILITY PROMISED TO SEND PARTS BACK IMMEDIATELY. AS OF 10/16/96, NO PARTS WERE RETURNED. HISTORICAL ANALYSIS OF NUMEROUS IDENTICAL COMPLAINTS (SEE FOR EXAMPLE: 0896037C3, 0796207C3, 0796157C3, 0796160C3, AND 0796180C3) INDICATE THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED ON THESE EARLIER COMPLAINTS THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IT APPEARS THAT THESE PROBLEMS OCCUR WITH NORMAL USE AND HANDLING OF THE CLAMP, AND NOT BECAUSE OF USER MISUSE, WHICH WAS ORIGINALLY CONSIDERED TO BE THE CAUSE. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE CS3 OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PATIENT CAN RESULT. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE BROKEN LINE CLAMP DESCRIBED IN THIS COMPLAINT WAS GENERATED BECAUSE OF WEAK TAB STOPS AND/OR CAM INSERT HOLDERS ON THE CLAMP. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT TISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027.
THE SCREWS HOLDING THE LEG OF ADJUSTABLE BASE CAME OUT OF CAUSING THE HOIST TO TIP. A LADY PT FELL OFF THE SEAT, NO INJURY TO PT OR STAFF. ONE PERSON INVOLVED.
THE FOLLOWING IS THE CLOSING OUT REPORT FROM THE FOREIGN REPORTER. INVESTIGATION: THE RIGHT HAND LEG WAS COMPLETELY DETACHED, THE SCREWS WERE MISSING AND COULD NOT BE FOUND IN THE BATHROOM WHERE THE INCIDENT OCCURRED. THE LEFT HAND LEG SCREWS WERE FOUND TO BE SLACK. OBSERVATIONS: THE ENVIRONMENT WAS FOUND TO BE A TYPICAL HOSPITAL BATHROOM/CORRIDOR WITH LINO FLOORING, IT HAD A SMOOTH FINISH WITH NO BUMPS. CONCLUSIONS: USER ERROR BECAUSE OF POOR MAINTENANCE. CORRECTIVE ACTION: MISSING SCREWS WERE REPLACED AND LOOSE ONES TIGHTENED. IT HAS BEEN REQUESTED THAT ALL OTHER LIFTS ON SITE BE CHECKED FOR LOOSE SCREWS.
ACCORDING TO THE SOURCE, THE PUMP INDICATED THE TOTAL DELIVERED WAS 20 CC WHEN ACTUALLY THE SYRINGE DIDN'T MOVE. THE PUMP WAS PROGRAMMED TO DELIVER 60 CC OF PLATELETS OVER 2 HRS IN VOLUME OVER TIME MODE. AFTER ONE HR THE NURSE CHECKED THE PUMP AND NOTED THAT NOTHING HAD INFUSED. SHE ALSO NOTED THAT THE SYRINGE WAS INCORRECTLY LOADED. THE SYRINGE WAS RELOADED AND THE PUMP WAS CHECKED AFTER 30 MINS. STILL NOTHING HAD INFUSED.
THIS M.D.R. IS BEING FILED IN ORDER TO COMPLY WITH 21 CFR PART 803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT THE DEVICE ACTUALLY MALFUNCTIONED OR CAUSED ANY INJURY. HISTORY REVIEW: THERE ARE NO DELIVERY RECORDS MATCHING DELIVERY VOLUME AND TIME AS STATED BY CUSTOMER. RECORDS INDICATE PUMP DELIVERED AS PROGRAMMED, HOWEVER VOLUME DELIVERED WAS LOW ENOUGH TO BE PERCEIVED AS NO DIFFERENCE IN SYRINGE VOLUME. THIS EVENT IS BEING REPORTED AS A MALFUNCTION BECAUSE EVAL DATA IS NOT CONCLUSIVE. H3: 68 NO REPAIR REQUIRED.
10/3/96 MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
THE SUTURE BREAKS DURING CONTINUOUS SUTURING. WOUND DEHISCENCE. EXPIRATION DATE 02/01.
INVESTIGATION IS IN PROGRESS. PMA # P840861. REF MFR COMPLAINT #Z96-323. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO AND TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILIY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
BZ X-TUBE ASSEMBLY 18" X 18". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO, OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
IT WAS REPORTED DURING A SIGMOID COLECTOMY, DURING THE FIRST FIRING OF THE TCT75 THE SURGEON ATTEMPTED TO TRANSECT THE COLON BUT THE STAPLES DID NOT FORM ALL THE WAY. SOME STAPLES WERE IN THE TISSUE AND SOME JUST SEEMED TO DEFLECT. HE THEN REMOVED THAT SECTION WHERE THE STAPLES HAD PARTIALLY FORMED AND PROCEDED TO OPEN A SECOND TCT75 TO TRANSECT THE COLON AGAIN. THIS TIME IT WAS SUCCESSFUL. THERE WAS NO CONSEQUENCE TO THE PT.
D5; H3,4,6;G4: ADDED ADDITIONAL INFO. CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS FIRED WITH A RELOAD CARTRIDGE AND FIRED AND FORMED STAPLES AS DESIGNED ACROSS THE ENTIRE STAPLE LINE. THERE WERE NO MALFORMED STAPLES NOTED. THE REPORTED INCIDENT COULD NOT BE RECREATED. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
THE RETURNED IMPLANT WAS EVALUATED AND MEETS SPECIFICATIONS.  THE REPORTED INFECTION IS THE PROBABLE CAUSE OF FAILURE.
THE PT WAS CONFUSED AND DISCONNECTED THE PERCUTANEOUS LEAD FROM THE INTERCONNECT CABLE. NO ALARM SOUNDED. IT IS REPORTED TO CO THAT WHILE BEING SUPPORTED BY A LEFT VENTRICULAR ASSIST SYSTEM, THE PT BECAME CONFUSED AND DISCONNECTED THE PERCUTANEOUS LEAD OF THE LVAD FROM THE INTERCONNECT CABLE OF THE CONSOLE. THE EVENT DID NOT RESULT IN A WARNING ALARM.
ALL INFO WAS SUPPLIED BY THE MFR. NO MEDWATCH 3500A WAS RECEIVED FROM THE USER FACILITY.
A RETURN GOODS AUTHORIZATION WAS ISSUED FOR THE AFFECTED ASSEMBLY ON 9/16/96. HOWEVER, AS OF 10/7/96, NO CLAMPS WERE RETURNED FOR INVESTIGATION. THE FACILITY HAS NOT RETURN THE DEFECTIVE CLAMPS BECAUSE THEY HAVE NOT REPLACED THE CLAMP ASSEMBLIES ON THE MACHINES. ON 10/7/96, QUALITY ASSURANCE CONTACTED THE FACILITY AND STRONGLY ENCOURAGED THEM TO RETURN PARTS FOR INVESTIGATION. THE FACILITY PROMISED TO SEND PARTS BACK IMMEDIATELY. AS OF 10/16/96, NO PARTS WERE RETURNED. HISTORICAL ANALYSIS OF NUMEROUS IDENTICAL COMPLAINTS (SEE FOR EXAMPLE: 0896037C3, 0796207C3, 0796157C3, 0796160C3, AND 0796180C3) INDICATE THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED ON THESE EARLIER COMPLAINTS THA THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IT APPEARS THAT THESE PROBLEMS OCCUR WITH NORMAL USE AND HANDLING OF THE CLAMP, AND NOT BECAUSE OF USER MISUSE, WHICH WAS ORIGINALLY CONSIDERED TO BE THE CAUSE. IT THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALLL A LUER CAP ONTO THE LINE. THE CS3 OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PATIENT CAN RESULT. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE BROKEN LINE CLAMP DESCRIBED IN THIS COMPLAINT WAS GENERATED BECAUSE OF WEAK TAB STOPS AND/OR CAM INSERT HOLDERS ON THE CLAMP. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027.
PT WAS IN SLING BEING LIFTED INTO THE BATH TUB, WHEN LETTING HER DOWN INTO THE TUB AT APPROX 12" ABOVE THE BOTTOM OF THE TUB, BOLT/PIN BROKE, LETTING HER FALL APPROX 12". PT WAS NOT INJURED. ONE PERSON INVOLVED.
THIS LIFT WAS OVERLOOKED IN THE UPGRADE PROGRAM INITIATED 6/28/94 WHICH REPLACED THE HANGER. A TECHNICIAN TOOK THIS UNIT OUT OF SERVICE AND A WORK ORDER WAS INITIATED ON 9/11/96. UNIT HAS BEEN SATISFACTORILY UPDATED AND COMPLETED, AN ACKNOWLEDGEMENT OF THIS IS IN THE FILE. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y. WILL ADD'L INFO PROVIDED AFTER 15-DAY REPORT? N. DISCLAIMER: THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21CFR600, 803, 1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUCNTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
DURING TESTING, THE UNIT WON'T READ RHYTHM PROPERLY. NO PT INVOLVED.
THIS MALFUNCTION HAPPENED DURING TESTING OF THE DEVICE BY THE CUSTOMER. NO PT WAS INVOLVED AT THE TIME OF THE MALFUNCTION. THE DEVICE WAS EVALUATED BY A FIELD SVC TECH WHO VERIFIED THE REPORTED COMPLAINT DURING A SIX INCH DROP TEST WHILE THE DEVICE WAS ANALYZING A SIMULATED RHYTHM. THE SOLDER JOINT OF A FILTERING RESISTER WAS FOUND TO BE CRACKED, CAUSING THE INPUT RHYTHM TO BECOME DISTORTED. THE SOLDER CONNECTION WAS REPAIRED AND PROPER OPERATION OF THE DEVICE WAS VERIFIED. THE DEVICE WAS THOROUGHLY TESTED TO ALL DEVICE SPECS AND WAS FOUND TO BE FULLY COMPLIANT, OPERATING NORMALLY THROUGH ALL TESTS COMPLETED. THIS TESTING INCLUDED DEVICE ASSESSMENTS OF APPROX THIRTY CHALLENGING HEART ARRHYTHMIAS. THE DEVICE PROPERLY DISTINGUISHED THE APPROPRIATE RHYTHMS TO TREAT IN EVERY CASE AND CORRECTLY FOLLOWED ITS PROTOCOL. FINALLY FIELD SVC TECH VERIFIED THE DEVICE'S CALIBRATION AND SUCCESSFULLY CONDUCTED A FUNCTIONAL ARRHYTHMIA TEST WITHOUT OBSERVING ANY PERFORMANCE DEVIATIONS OR IRREGULARITIES.
BZ X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
DURING A HERNIA PROCEDURE, THE INSTURMENT WOULD NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/3/96-MEDWATCH NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
A FACILITY REPORTED THAT DURING PT TREATMENT A BLOOD ALARM OCCURRED WITH APPROPRIATE VISUAL AND AUDIBLE RESPONSE. THE MACHINE'S BLOOD PUMP STOPPED APPROPRIATELY, BUT THE VENOUS LINE OCCLUDING CLAMP DID NOT CLOSE AS EXPECTED. THE MACHINE HAD PASSED THE PRETREATMENT ALARM TESTS. PT INJURY IS NOT LIKELY TO OCCUR UNLESS THE OPERATOR OVERRIDES THE ALARM CONDITION. THE NURSE CLAMPED THE PT'S BLOODLINES AND DISCONNECTED THE PT FROM THE EXTRACORPOREAL CIRCUIT. THE BLOOD WAS RECIRCULATED WHILE THE LEVEL DETECTOR MODULE WAS REPLACED, PROPER OPERATION VERIFIED AND THE TREATMENT RESTARTED. THERE WAS NO BLOOD LOSS AND NO PT INJURY. THE TREATMENT WAS COMPLETED WITHOUT INCIDENT.
EVAL IS IN PROGRESS. THE MODULE IS MADE BY MFR.
THE SVC REPORT SHOWS WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE UNIT, THE SVC TECH (ST) VERIFIED THE DEVICE DID NOT PASS THE VOLUME DELIVERY TESTING. THE ST INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
DURING A HERNIA PROCEDURE, THE INSTURMENT WOULD NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. THE PT'S HYPERTENSIVE CONDITION IS A PROBABLE CONTRIBUTOR TO THE IMPLANT FAILURE.
WHEN ATTEMPTING A POST DILATION STENT PROCEDURE, THREE CATHETERS WERE USED AND ALL THREE CATHETER BALLOONS RUPTURED AT OR AROUND 6 ATM. THE PROCEDURE WAS STOPPED AFTER REMOVAL OF THE THIRD CATHETER. NO PT INJURY OR FURTHER COMPLICATIONS WERE REPORTED. UNK
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR. BLOCK H6, METHOD CODE 86, USED AS NO METHOD FOR EVAL WAS POSSIBLE AS THE SAMPLES WERE DISCARDED BY THE USER. BLOCK H6, CONCLUSION CODE 68, USED AS THE PRODUCT WAS NOT BEING USED FOR ITS LABELED INDICATIONS.
A BALLOON RUPTURED ON THE FIRST INFLATION AT 10 ATMS DURING A SUPERFICIAL FEMORAL ANGIOPLASTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION, CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON, THE BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS... IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF THE BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
THE SVC REPORT SHOWS THAT WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE UNIT, THE CO SVC TECH (ST) VERIFIED THE DEVICE DID NOT PASS THE VOLUME DELIVERY TESTING. THE ST INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
A RETURN GOODS AUTHORIZATION WAS ISSUED FOR THE AFFECTED ASSEMBLY ON 9/16/96. HOWEVER, AS OF 10/7/96, NO CLAMPS WERE RETURNED FOR INVESTIGATION. THE FACILITY HAS NOT RETURN THE DEFECTIVE CLAMPS BECAUSE THEY HAVE NOT REPLACED THE CLAMP ASSEMBLIES ON THE MACHINES. ON 10/7/96, QUALITY ASSURANCE CONTACTED THE FACILITY AND STRONGLY ENCOURAGED THEM TO RETURN PARTS FOR INVESTIGATION. THE FACILITY PROMISED TO SEND PARTS BACK IMMEDIATELY. AS OF 10/16/96, NO PARTS WERE RETURNED. HISTORICAL ANALYSIS OF NUMEROUS IDENTICAL COMPLAINTS (SEE FOR EXAMPLE: 0896037C3, 0796207C3, 0796157C3, 0796160C3, AND 0796180C3) INDICATE THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED ON THESE EARLIER COMPLAINTS THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IT APPEARS THAT THESE PROBLEMS OCCUR WITH NORMAL USE AND HANDLING OF THE CLAMP, AND NOT BECAUSE OF USER MISUSE, WHICH WAS ORIGINALLY CONSIDERED TO BE THE CAUSE. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE CS3 OPERTOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PATIENT CAN RESULT. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE BROKEN LINE CLAMP DESCRIBED IN THIS COMPLAINT WAS GENERATED BECAUSE OF WEAK TAB STOPS AND/OR CAM INSERT HOLDERS ON THE CLAMP. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027.
IT WAS REPORTED THE EZ35B WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE DEVICE WAS FIRED AND THE SURGEON HAD TO MANUALLY OPEN THE INSTRUMENT BY PUSHING OPEN THE BLACK FIRING TRIGGER. THE DEVICE WAS RELOADED WITH AN ERU35B AND AFTER THE SECOND FIRING IT WOULD NOT OPEN. THE SURGEON HAD TO PULL THE CLOSED INSTRUMENT OFF THE TISSUE TO RELEASE IT. ELECTROCAUTERY WAS USED TO ACHIEVE HEMOSTASIS FOR BLEEDERS ALONG THE STAPLE LINE. NO BUTTERSSING WAS USED. THERE WAS NO CONSEQUENCE TO THE PT.
CO 964755. A1,2,3,4; B6, 7; D10 ATTEMPTED TO CONTACT SURGEON. INFO NOT AVAILABLE. D5, 6; H4 DEVICE WAS NOT AVAILABLE FOR ANALYSIS. INFO NOT AVAILABLE. H6 INFO NOT AVAILABLE AT THIS TIME.
AN OVERINFUSION OCCURRED. THE PUMP WAS SET AT A RATE OF 125ML/HR AT 1615H. AT 1715HR IT WAS NOTICED THAT THE BAG WAS EMPTY. NO PT CONSEQUENCE WAS ASSOCIATED WITH THIS EVENT.
THE DEVICE WAS RETURNED FOR INVESTIGATION. AS OF THE DATE OF THIS REPORT THE INVESTIGATION HAS NOT BEEN COMPLETED. SECTIONS A,B,D,E,F, AND G WERE COMPLETED BY THE DEVICE MFR. SECTION A4,F7,8,10 INFO NOT PROVIDED BY USER. MFR'S REPORT DATE 9/27/96.
PRODUCT DID NOT DISSOLVE AND HAD TO BE REMOVED FROM PT'S EYE. A CORNEAL ABRASION WAS OBSERVED AND TREATED WITH ANTIBIOTIC OINTMENT AND RESOLVED IN 5 DAYS. THE PRODUCT WAS USED AFTER AN UNCOMPLICATED CATARACT PROCEDURE AND WAS SOAKED IN TOBRADEX PRIOR TO APPLICATION. HE REPORTS THE POTENTIAL FOR INJURY EXISTS IF THIS INCIDENT WERE TO RECUR.
RESIDENT FELL OFF THE TOILET SEAT BECAUSE THE SEAT EXTENDER WAS LOOSE.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP THE CLIPS FELL OUT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFORMATION NOT PROVIDED BY AFFILIATE. 8/30/96 CONTACTED AFFILIATE "DID CLIPS FALL INTO THE PATIENT.?" RETRIEVED?-DSH 9/6/96 INFO REC'D-DSH. D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
DURING A DIALYSIS TREATMENT, THE HEPARIN/SALINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP. THE STAPLES ARE NOT DELIVERED. THERE WAS NO CONSEQUENCE TO THE PT.
H6; INSTRUMENT REC'D WITH THE DRIVER DETACHED FROM THE MOLDED DRIVER BUFFER LINK AND PRECOCK MECHANISM WAS NON FUNCTIONAL. THE CRIMP HAD ALSO YIELDED.
THE SVC REPORT SHOWS WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE UNIT, THE SVC TECH VERIFIED THE DEVICE AUDIBLE ALARM DID NOT SOUND. THE ST INSPECTED THE DEVICE AND REPLACED THE AUDIO ALARM CONTROLLER. THE UNIT EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
A BALLOON RUPTURED ON THE FIRST INFLATION AT 12 ATMS DURING A SUPERFICIAL FEMORAL ANGIOPLASTY OF A CALICIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. SINCE FOLLOW UP INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION, CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON, BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS... IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
A RETURN GOODS AUTHORIZATION WAS ISSUED FOR THE AFFECTED ASSEMBLY ON 9/16/96. HOWEVER, AS OF 10/7/96, NO CLAMPS WERE RETURNED FOR INVESTIGATION. THE FACILITY HAS NOT RETURN THE DEFECTIVE CLAMPS BECAUSE THEY HAVE NOT REPLACED THE CLAMP ASSEMBLIES ON THE MACHINES. ON 10/7/96, QUALITY ASSURANCE CONTACTED THE FACILITY AND STRONGLY ENCOURAGED THEM TO RETURN PARTS FOR INVESTIGATION. THE FACILITY PROMISED TO SEND PARTS BACK IMMEDIATELY. AS OF 10/16/96, NO PARTS WERE RETURNED. HISTORICAL ANALYSIS OF NUMEROUS IDENTICAL COMPLAINTS (SEE FOR EXAMPLE: 0896037C3, 0796207C3, 0796157C3, 0796160C3, AND 0796180C3) INDICATE THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED ON THESE EARLIER COMPLAINTS THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IT APPEARS THAT THESE PROBLEMS OCCUR WITH NORMAL USE AND HANDLING OF THE CLAMP, AND NOT BECAUSE OF USER MISUSE, WHICH WAS ORIGINALLY CONSIDERED TO BE THE CAUSE. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. CS3 OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PATIENT CAN RESULT. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE BROKEN LINE CLAMP DESCRIBED IN THIS COMPLAINT WAS GENERATED BECAUSE OF WEAK TAB STOPS AND/OR CAM INSERT HOLDERS ON THE CLAMP. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY A DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027.
WHILE RAISING THE X-RAY TABLE FROM THE HORIZONTAL TO VERTICAL POSITION, THE TABLE SLIPPED OFF ITS PIVOT JOINT AND DROPPED 4-6 INCHES TO THE FLOOR. IT WAS NOTED THAT A BLANKET WHICH HAD BEEN PLACED UNDER THE PT WAS CAUGHT IN THE TILT MECHANISM. ACCORDING TO THE CO SERVICEMEN, THE BLANKET HAD WRAPPED AROUND THE SPROCKET CAUSING THE CHAIN TO COME OFF THE SPROCKET AND WHEN THAT HAPPENED, THE TABLE SLIPPED DOWN.
IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THE STAPLES WOULD NOT DELIVER. THERE WAS NO CONSEQUENCE TO THE PT.
H6; INSTRUMENT WAS REC'D WITH AN INSUFFICIENT HEAD HOUSING WELD AND JAMMED STAPLES IN THE NOSE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP  THE CLIPS WERE DROPPING FROM THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6;H4,6: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
IT WAS REPORTED THE DEVICE USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THE DEVICE JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
CO 964864. A1, 2,3,4; B3,6,7 INFO NOT SUPPLIED BY AFFILIATE HOSP. D5,6 ANALYSIS NOT COMPLETED AT THIS TIME D10 INFO NOT SUPPLIED BY AFFILIATE HOSP. H4,6 ANALYSIS NOT COMPLETED AT THIS TIME.
A BALLOON CATHETER LEAKED DURING INFLATION. THERE WERE NO PT COMPLICATIONS. NO FURTHER INFO WAS PROVIDED AND ATTEMPTS TO GAIN FURTHER INFO WERE UNSUCCESSFUL. THIS DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH THE OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. HOWEVER, EVALUATING THE PRODUCT, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "DO NOT EXCEED THE NORMAL PRESSURE PRINTED ON THE PRODUCT LABEL. NEVER MANIPULATE THE CATHETER  WITH THE BALLOON INFLATED...THE INTEGRITY OF ALL BALLOON CATHETERS MAY BE COMPROMISED BY SHARP OBJECTS OR SURFACES. NOT RECOMMENDED FOR USE IN CALCIFIED LESIONS."
THE DEVICE WAS USED IN A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE CLIPS, FROM KIT FTR32, WERE NOT CLOSING ALL THE WAY. A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B3,6,7,D10-INFO NOT PROVIDED. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THE STAPLES WOULD NOT DELIVER. THERE WERE NO CONSEQUENCE TO THE PT.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP THE INSNTRUMENT MALFUNCTIONED, THERE WAS NO CONSEQUENCE TO THE PT. STAPLES WON'T CLOSE, LAS STAPLES WOULD NOT CLOSE DURING CO'S TEST.
A1,2,3,4;B3,6,7;D10: INFORMATION NOT PROVIDED BY AFFILIATE. 8/30/96 CONTACTED AFFILIATE "SPECIFIC NATURE OF THE MALFUNCTION?" DSH. 9/6/96 INFO REC'D-DSH. 9/6/96 STAPLES WON'T CLOSE, LAST STAPLES WOULD NOT CLOSE DURING TEST. DSH. D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE SVC REPORT SHOWS WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE DEVICE THE SVC TECH (ST) VERIFIED THE DEVICE DID NOT PASS THE VOLUME LEAK TEST. ST INSPECTED THE DEVICE AND MADE AN ADJUSTMENT TO THE CYLINDER. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
IMPLANT WAS PLACED 5/15/96, IN SITE # 18/19 MESIAL. IT WAS LATER REMOVED (EXACT DTE UNK) DUE TO INFECTION.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS.  THE PT'S REPORTED INFECTION, COMPOUNDED BY SMOKING AND ALLERGIES, IS THE LIKELY CAUSE OF FAILURE.
A BALLOON CATHETER RUPTURED DURING THE FIRST INFLATION OF A SUB-CLAVIAN DILATATION OF A VENOUS LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PT COMPLICATIONS. THIS DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. CO BELIEVES THESE FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE THEM TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE OF THIS EVENT. CO DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOONS RUPTURE DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY REP THE DEVICE JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY MAY HAVE CAUSED THE REPORTED INCIDENT DURING SURGERY. THE INSTRUMENTS WAS RECEIVED WITH EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY AND WAS CYCLED AND FIRED THE REMAINING 12 STAPLES INTERMITTENTLY. IT WAS CONCLUDED THAT THE EXCESSIVE DRIED BODY FLUIDS CAUSED THE STAPLES TO FEED INTERMITTENTLY DURING TESTING AND MAY HAVE CAUSED THE INSTRUMENT TO JAM DURING SURGERY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY.
X-TUBE ASEMBLY 16" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
THE DEVICE WAS USED DURING LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP THE DEVICE JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING WITH REGARD TO STAPLES FEEDING, FIRING AND FORMING. THE INSTRUMENT WAS RECEIVED WITH EXECESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY AND WITH NO STAPLE IN THE CARTRIDGE NOSE READY TO FIRE. THE INSTRUMENT WAS EXAMINED AND WAS FOUND TO BE FUNCTIONAL. THE INSTRUMENT WAS CYCLED AND THE FIRST STAPLE LOADED INTO THE NOSE AND THEN THE INSTRUMENT FIRED THE REMAINING 11 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT "JAMMED" DURING SURGERY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
IMPLANTED PLACED 5/15/96, DISTAL SITE #18/19.  IMPLANT REMOVED (EXACT DATE UNKNOWN) DUE TO INFECTION.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP  THE INSTRUMENT WAS BROKEN. THERE WAS NO CONSEQUENCE TO THE PT.
REPORTEDLY, ONE FREEZING CONTAINER WAS FOUND RUPTURED WHEN REMOVED FROM THE CASSETTE FOR THAWING AFTER STORAGE IN LIQUID NITROGEN. THE CONTENTS OF THE CONTAINER, PERIPHERAL BLOOD STEM CELLS, WERE DISPOSED OF AT THE TIME OF THE EVENT. SUFFICIENT BACK-UP CELLS WERE AVAILABLE TO TRANSPLANT THE PT. THE PT WAS NOT EFFECTED BY THE EVENT. THE SAMPLE WILL BE RETURNED FOR EVAL. AT THE TIME OF THIS REPORT THE SAMPLE HAD NOT BEEN RECEIVED. THE CONTAINERS AFTER REMOVAL FROM THE LIQUID NITROGEN STORAGE TANK ARE EXTREMELY FRAGILE IN THE FROZEN STATE. CARE MUST BE TAKEN WHEN HANDLING THE FROZEN PRODUCT NOT TO CAUSE ANY MECHANICAL DAMAGE TO PLASTIC CONTAINERS. SMALL CRACKS OR FRACTURES IN THE BODY OF THE CONTAINERS MAY CAUSE THE INGRESS OF LIQUID NITROGEN AND THE RUPTURE OF DISTENTION OF THE CONTAINERS. FREEZING AND THAWING RECOMMENDATION ARE DISTRIBUTED WITH EACH CONFIGURATION OF THE CONTAINERS.
PRODUCT WAS RECEIVED FOR EVALUATION 11/21/96. H6 UPDATED.
RN PLACED A 24 GA 3/4" CATHETER IN THE LT BASILIC VEIN, VERIFIED PLACEMENT WITH NS FLUSH AND BEGAN IV INFUSION OF ROCEPHIN 1 GM X 5 DAYS PER MD ORDER. TWENTY FIVE MINUTES INTO INFUSION, LT ARM BEGAN TO SWELL, REDDEN, BECOME TENDER. IV ANTIBIOTIC STOPPED, VSS WITHOUT CHANGE, AND GOOD BLOOD RETURN NOTED IN EXTENSION TUBING. PT HAD HAD IM ROCEPHIN THE PREVIOUS DAY WITHOUT PROBLEM. IV PULLED OUT AND ICE PLACED ON AREA. IV RESTARTED WITH A DIFFERENT 24 GA 3/4" CATHETER AND SECURED WITH  BANDAGE. PLACEMENT VERIFIED WITH NSS FLUSH. PT RETURNED NEXT DAY, 9/7/96, FOR IV ASSESSMENT. DR WAS NOTIFIED AND AWARE OF CATHETER REACTION.
X-TUBE ASSEMBLY 15" X 16". DEALER CLAIMS X-TUBE BROKE AT THE TOP WELD.
IT WAS REPORTED THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC COLECTOMY. IT WAS REPORTED THE INSTRUMENT FIRED 4 TIMES SUCCESSFULLY, BUT WOULD NOT FIRE ON THE 5TH ATTEMPT. THERE WAS NO CONSEQUENCE TO THE PT. NO BUTTRESSING MATERIAL WAS USED.
CO 964790. A1,2,3,4; B6,7; D10 CONTACTED SURGEON, INFO NOT AVAILABLE. D5; H4, H6 INFO NOT AVAILABLE AT THIS TIME. BASED UPON THE INQUIRY INFO REC'D THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT WAS CYCLED, FIRED, CUT AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE ITS PRODUCTS.
THE RUBBER VALVE IN THE INTRODUCER LOOSENED AND CAME OUT OF THE BOTTOM OF THE SHEATH.
D1, D2 & D6: CORRECTIONS PER FDA LETTER DATED 06/03/97. THIS IS AN ATTEMPT TO CLARIFY THE DESCRIPTION OF THE BRAND NAME, DEVICE TYPE AND MODEL NAME IN AN EFFORT TO FACILITATE THE MEETING OF MDR REPORTS TO THE CORRESPONDING BASELINE REPORT. H7: ERROR. NO REMEDIAL ACTION WAS INITIATED. INITIAL REPORT INCORRECTLY INDICATED THAT "NOTIFICATION" WAS GIVEN.
THE INSTRUMENT WAS USED DURING A LAPAROSOCPICALLY ASSITED VAGINAL HYSTERECTOMY. IT WAS REPORTED ON THE THIRD OR FOURTH FIRING THE STAPLER WOULD NOT STAPLE OR CUT. ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED. NO BUTTRESSING MATERIAL WAS USED. THERE WAS NO CONSEQUENCE TO THE PT. THE INSTRUMENT WAS FROM AN FT050. REP ALSO RETURN 2-EVU35 RELOADS WITH THE INSTRUMENT, UNK LOT/BATCH NUMBERS.
CO'S #: 964472. 8/29/96 1505 MESSAGE AND 800# LEFT FOR MD CALL BACK. 8/29/96 THE SURGEON STATED THE DEVICE WORKED FIRE FOR THE FIRST FEW FIRINGS. ON THE THIRD OR FOURTH FIRING, HE FELT RESISTANCE AS HE TRIED TO FIRE. HE THEN REMOVED THE INSTRUMENT AND PUT IN A NEW CARTRIDGE. IT STILL WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIMS X-TUBE BROKE AT THE TOP OF THE WELD.
IMPLANT WAS PLACED 4/5/96. IMPLANT FAILED, DATE UNKNOWN, AND WAS REMOVED DUE TO INFECTION AND MOBILITY.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS.  THE PT'S INFECTION, COMPOUNDED BY SMOKING, HYPERTENSION, AND ALLERGIES, IS THE PROBABLE CAUSE OF FAILURE.
IT WAS REPORTED THE DEVICE WAS USED DURING DURING A THORACTOMY. IT WAS REPORTED THE MCL20 CLIPS WERE JAMMING AND NOT FORMING PROPERLY. THERE WAS NO CONSEQUENCE TO THE PT. REP REPORTS A SECOND MCL20 WAS INTRODUCED TO COMPLETE THE CASE.
CO 964752. A1,2,3,4; B6,7; D10 ATTEMPTED TO REACH SURGEON. INFO NOT AVAILABLE. D5; H4,6 ANALYSIS NOT COMPLETED.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. THE STAPLES DID NOT FORM PROPERLY WHEN INSTRUMENT WAS FIRED AND THE SURGEON FINISHED THE CASE BY HAND SEWING. REP HAS SINCE REVIEWED FIRING PROCEDURE WITH THE SURGEON. THE REP IS RETURNING TWO STAPLES. THE INSTRUMENT WAS NOT SAVED. THERE WAS NO CONSEQUENCE TO THE PT.
D6; DEVICE RETURNED WITH NO LOT IDENTIFICATION.
THE DEVICE WAS USED DURING A LAP SPLENECTOMY PROCEDURE. IT WAS REPORTED DEVICE MADE A LOUD CRACKING SOUND AS STAPLER WAS FIRED. THERE WAS NO CONSEQUENCE TO THE PT.
H6: ADDED EVALUATION CODES (CODE 400 = DAMAGED FIRING MECHANISM)
DURING A CATARACT EXTRACTION PROCEDURE, THERE WAS NO BIPOLAR OUTPUT WITH THIS OPHTHALMIC MICROSURGICAL UNIT. ANOTHER UNIT WAS BROUGHT IN TO SUCCESSFULLY COMPLETE THE CASE.
REPORT RECIEVED OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
THREE PROBLEMS IDENTIFIED: 9/13/96, IV FELT "ROUGH" GOING THROUGH VEIN; PT CHOSE NOT TO CONTINUE; CATHETER APPEARDED "ROUGH". 9/18/96, UNABLE TO CANNULATE VEIN; NEEDLE COULD NOT EVEN GO THROUGH SKIN. 9/19/96, STARTING #18 CATHETER WITH GOOD RETURN, BUT COULD NOT ADVANCE CATHETER FURTHER, THE TIP APPEARED BLUNT.
IT WAS REPORTED THAT HOIST DROPPED WHILE STAFF WERE USING THE HOIST IN THE SLING POSITION. NO INJURY TO STAFF OR PT.
THE FOLLOWING IS A CLOSING OUT REPORT BY THE FOREIGN REPORTER. INVESTIGATION: NO FAULTS WERE FOUND ON THE MACHINE, THE MACHINE HAD BEEN RECENTLY REPAIRED AND A NEW CHAIN HAD BEEN FITTED. OBSERVATIONS; THE HANDLE MUST HAVE WOUND OFF TO ALLOW JIB TO FALL. CONCLUSIONS: CAUSE OF FAILURE DUE TO SIDE PRESSURE. CORRECTIVE ACTION: A QUOTE HAS BEEN SENT TO THE CUSTOMER FOR A SPRAG CLUTCH.
IT WAS REPORTED THE DEVICE WAS USED DURING A DIAGNOSTIC LAP. IT WAS REPORTED THE 512 S HAD A NOTE WRITTEN ON THE BLISTER STATING "SAFETY SWITCH, OR RED BUTTON, KEEP RELEASING WITHOUT DOCTOR BEING IN THE ABDOMINAL CAVITY". REP COULD OBTAIN NO FURTHER INFO REGARDING THE EVENT. THERE WAS NO CONSEQUENCE TO THE PT.
CO 964746. A1,2,3,4; B6,7; D10 CONTACTED SURGEON. INFO NOT AVAILABLE. D SECOND PRODUCT. INFO IN D1-10 IS THE SAME. D5, 6: H4,6 ANALYSIS NOT COMPLETED.
IMPLANT WAS PLACED 3/15/96 AND UNCOVERED 7/26/96. NO PROBLEMS WERE NOTED BY THE DR. ABUTMENT WAS PLACED. PT  CAME IN ON 9/16/96 WITH THE IMPLANT IN HIS HAND. NO PAIN WAS NOTED. PT WAS IN GOOD HEALTH. ONE PERSON AFFECTED.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE WAS SPITTING CLIPS WHEN FIRED. THERE WAS NO CONSEQUENCE TO THE PT. 9/6/96 IT WAS REPORTED THE CLIPS DID FALL INTO THE PT AND WERE RETRIEVED. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.
A1,2,3,4,B6,7,D10-INFORMATION NOT PROVIDED BY USER FACILITYH4,D5,6-INFORMATION NOT AVAILABLEH6: CODE 400(OTHER): YIELDED JAWS
X-TUBE ASSEMBLY 18" X 15". DEALER CLAIMS X-TUBE BROKEAT THE CENTER BOLT.
IT WAS REPORTED THE DEVICE WAS USED DURING A LUNG PROCEDURE. IT WAS REPORTED BY THE REP. THE STAPLES WOULD NOT DELIVER. THERE WAS NO CONSEQUENCE TO THE PT.
CO 964877. A1,2,3,4; B6,7 INFO NOT SUPPLIED BY AFFILIATE HOSP. D5,6 ANALYSIS NOT COMPLETED. D10 INFO NOT SUPPLIED BY AFFILIATE HOSP. H4,6 ANALYSIS NOT COMPLETED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA PROCEDURE. IT WAS REPORTED THE STAPLES FROM DEVICE MALFORMED WHEN FIRED INTO COOPER'S LIGAMENT. THE SURGEON PRECOCKED THE DEVICE BEFORE FIRING. A SECOND DEVICE OPENED AND THE SAME DIFFICULTY WAS EXPERIENCED.
H6; CODE 400: INSTRUMENT WAS RETURNED EMPTY. RESULTS OF EVALUATION: AB)BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT'S STAPLES "MALFORMED" DURING SURGERY. A)THE INSTRUMENT WAS RECEIVED EMPTY, BUT OTHERWISE WAS IN GOOD PHSICAL CONDITION. B)THE INSTRUMENT WAS RECEIVED  WITH THE CARTRIDGE UNATTACHED AND EMPTY. THERE WERE 5 STAPLES, WHICH HAD BEEN FIRED PREVIOUSLY, RETURNED WITH THE INSTRUMENT. THE STAPLES WERE EXAMAINED AND WERE OBSERVED TO BE, 1 OF WHICH HAD FORMED PROPERLY, 2 OF WHICH APPEARED TO HAVE PARK BENCH FORM, AND 2 OF WHICH HAD ONE LEG OF THE STAPLE PARK BENCHED. THE STAPLES WERE ALL OBSERVED TO BE COVERED WITH TISSUE RESIDUE. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE INSTRUMENTS BEING RETURNED EMPTY. COMMENTS: AB)EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. THE INSTRUMENT'S STAPLES MAY MALFORM OR REFLECT IF FIRED INTO A HARD OBJECT, SUCH AS BONE. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOULSY IMPROVE PRODUCTS.
REPORT RECEIVED OF INTER ELECTRODE REGION KINKED WITH WIRE FRACTURE NOT SUSPECTED.
TWO IMPLANTS WERE PLACED 7/31/96. ONE FAILED (DATE UNKNOWN). PT IS A SMOKER.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. THE PT'S SMOKING IS THE PROBABLE CAUSE OF FAILURE.
IMPLANT PLACED 4/26/96. UPON RECOVERING, 1 OF 3 IMPLANTS WAS LOOSE. DR TOOK IT OUT, PT HAD COMPLAINED OF PAIN. HE HAS ARTHRITIS AND HAS HAD A FEW X-RAY IN THE LAST MONTH.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE PT'SARTHRITIS MAY HAVE CONTRIBUTED TO THE FAILURE.
A CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS) PT REPORTED THAT SOLUTION ADMINISTRATION SET LEAKED AT THE CONNECTION TO PT'S CATHETER. THERE WAS NO INJURY, BUT PT WAS TREATED PROPHYLACTICALLY.
PT DID NOT RETURN ACTUAL COMPLAINT DEVICE, BUT DID RETURN 4 OTHER OF SAME LOT. ALL WERE TESTED AND PERFORMED TO SPECIFICATION. PD 8402
X-TUBE ASSEM 17" X 16". DEALER CLAIMS: X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP. THE INSTRUMENT JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D10,E1,2,3-INFORMATION NOT PROVIDED BY AFFILIATE. H4; D5,6-INFORMATION NOT AVAILABLE. BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT MAY HAVE BEEN DRY FIRED CAUSING THE STAPLES TO JAM BETWEEN THE HOLDER AND THE BACK OF THE ANVIL. THE INSTRUMENT WAS RETURNED WITH A FORMED AND A PARTIALLY FORMED STAPLE JAMMED IN THE CARTRIDGE NOSE, WHICH WERE REMOVED, AND THE INSTRUMENT WAS CYCLED AND FIRED THE REMAINING 21 STAPLES WITHOUT INCIDENT. THE INSTRUMENT IS NOT DESIGNED TO BE FIRED WHILE NOT IN TISSUE OR A GAUZE SIMULATION OF TISSUE. ONCE THE STAPLE IS FORMED, THERE IS NO MEDIA TO PULL THE STAPLE OUT OF THE TIP OF THE INSTRUMENT.
ALLEGEDLY, THE JACK BECAME UNATTACHED FROM THE CROSS BAR AND THE JACK SHAFT BROKE THROUGH THE FOOT END LITTER SKIN. NO INJURY WAS REPORTED. THE CO SER REP REPORTS THAT UPON INSPECTION HE FOUND THE BOLT THAT HOLDS THE JACK INTO THE CROSSBAR WAS MISSING.
THE CO SER REP NOTED THAT THE STRETCHER APPEARED TO BE IN POOR CONDITION DUE TO A LACK OF MAINTENANCE.
MYLAR PORTION OF CUSTOM KIT POUCH IS STICKING TO THE TAPE ON THE OUTSIDE OF THE SHIPPER CARTON, THEREBY CAUSING THE POUCH TO TEAR, AND LOSE STERILITY. THIS PRODUCT WAS NOT USED ON PTS.
IT HAS BEEN DETERMINED THAT BOX KNIFE CUTS BY RECEIVING AT THE  END UF CAUSED THE KIT IS BEING REVISED TO INCLUDE A LAYER OF BUBBLE-WRAP ABOVE THE TOP KIT IN THE BOXES. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.  THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF NAMIC USA CORP THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CASUALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
THE PUMP RATE CHANGED FROM 80 ML/HR TO 150 ML/HR DURING USE ON A PT. NO PT CONSEQUENCE WAS REPORTED.
CO'S INVESTIGATION OF THE DEVICE COULD NOT DUPLICATE THE REPORTED FAILURE OF RATE CHANGE. VISUAL INSPECTION OF THE FRONT KEY PANEL DID REVEAL OLD OVERLAYS WITH CRACKS, AND DRIED SOLUTION WAS NOTED UNDER THE OVERLAY. IT IS KNOWN THAT FLUID INGRESS CAN AFFECT KEYPAD ACTIVATION, HOWEVER, IT IS NOT KNOWN THAT THIS CAUSED THE REPORTED RATE CHANGE. THE PUMP WAS TESTED BY THE FACILITY BIOMED DEPT AND NO FAULT WAS FOUND. THE HOSP DOES CONCLUDE THAT THIS INCIDENT MAY HAVE BEEN USER ERROR. BLOCK A1,2,4, B6,7, D10 INFO NOT PROVIDED. BLOCK F COMPLETED BY MFR, F10 UNK. CO WILL RECOMMEND TO THE USER FACILITY REPLACING ALL WORN OR CRACKED OVERLAYS TO PREVENT FLUID INGRESS.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP. THE TWO INSTRUMENTS WERE USED IN SAME SURGERY. BOTH INSTRUMENTS JAMMED DURING SURGERY. SWITCHED TO A NEW INSTRUMENT TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
H6; INSTRUMENT RETURNED WITH A YIELDED ROTATING HEAD HOUSING WELD.
DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY DEVICE WAS USED FROM A FT050 FLEXTRAY. THE TRIGGER BROKE WHEN IT WAS SQUEEZED. ANOTHER DEVICE WAS OPENED AND THE TRIGGER BROKE IN THE SAME MANNER. THERE WAS NO CONSEQUENCE TO THE PT. THE DEVICES WERE DISCARDED. THE SALES REP REQUESTED THE HOSP SAVE DEVICES IN THE FUTURE FOR ANALYSIS.
A1,2,3,4;B6,7;D10: INFORMATION UNAVAILABLE. 9/5/96 1445 MESSAGE AND 800# LEFT FOR MD CALL BACK. BAH. 9/5/96 NNCL SENT. BAH. D5,6;H4,6: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
DURING A CESAREAN SECTION, ON 8/21/96, OF A HIGH RISK OB WITH KNOWN HEPATITIS C AND B ANTIGENS, THE SURGEON EXPERIENCED STRIKETHROUGH "MIDWAY THROUGH THE CHEST AND AT THE SIDE". REPORTED THAT THE SURGEON "USED 2 GOWNS OUT OF THE CESAREAN SECTION PACK. THE BLOOD SEEPED THROUGH TO HIS UNDERWEAR."
DATE SENT TO FDA: 09/27/96D5-EXPIRATION DATE IS REFLECTIVE OF THE PACK THIS PRODUCT WAS IN.D6-LOT#IS REFLECTIVE OF THE PACK THIS PRODUCT WAS IN.D9-FACILITY REFUSED TO RELEASE PRODUCT FOR INVESTIGATION. AGREED TO SITE VISIT FOR INVESTIGATION OF SAMPLE AT FACILITY, BUT COULD ONLY VISUALIZE.E4-FACILITY(INITIAL REPORTER) STATED THAT THEY WERE NOT REQUIRED TO REPORT THIS INCIDENT BECAUSE IT IS A PRODUCT NOT A DEVICE.F10-THE PT CODES REFER TO THE SURGEON WEARING THE PRODUCT, NOT THE PATIENT HE WAS CONDUCTING THE CESAREAN SECTION ON.H1-TYPE OF REPORTABLE EVENT IS "OTHER:EXPOSURE THAT COULD LEAD TO LONG TERM MEDICAL DIFFICULTIES."H3-UNABLE TO EVALUATE PRODUCT DUE TO FACILITY'S REFUSAL TO ALLOW NON-DESTRUCTIVE TESTING OF THE SAMPLE.
PT WAS RECEIVING ELECTRICAL STIMULATION TREATMENT TO LT HIP AS AN OUTPT IN THE PHYSICAL THERAPY DEPT, WHEN HE EXPERIENCED AN ELECTRICAL CHARGE DOWN HIS LT LEG. THE TREATMENT TECH WAS SUMMONED BY THE PT. THE TECH OBSERVED THE PT'S RT LEG MOVING, AND HE COMPLAINED OF INCREASED PAIN. TREATMENT WAS TERMINATED. THE EQUIPMENT WAS TAKEN OUT OF SERVICE AND REFERRED TO THE BIOMEDICAL ENGINEER FOR EVALUATION. THE PT WAS ESCORTED TO THE EMERGENCY ROOM FOR EVALUATION BY THE ER DR. ER DR DOCUMENTED ELECTRICAL SHOCK WITH NO SIGN OF INJURY. PLAN: HE IS TO SEE HIS FAMILY DR AS DIRECTED AND RETURN HERE FOR ANY FURTHER PROBLEMS. TEST RESULTS FOUND THE MACHINE IS WITHIN MFR'S TOLERANCES. TESTING WAS COMPLETED ON THE LEADS AND THE FOUR-LEAD CABLE. NO FAILURES WERE OBSERVED IN THE LEADS. THE FOUR LEAD CABLE DID EXPERIENCE FAILURE WHEN PHYSICAL CHANGES AT THE CONNECTOR END OF THE CABLE WERE MADE. THIS CABLE FAILURE COULD RESULT IN A CHANNEL TURNING ON OR OFF BY ANY CABLE MOVEMENT, THUS INCREASING OR DECREASING ELECTRICAL STIMULATION.
THE DEVICE WAS USED DURING A COROANRY ARTERY BYPASS GRAFT. IT WAS REPORTED BY THE REP. THE CLIP COULD NOT FEED INTO THE JAW. THE CASE COMPLETED WITH ANOTHER INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: INFO NOT PROVIDED BY AFFILIATE. D5,6; H4: INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE SURGEON FELT THERE WAS TOO MUCH MOTION BETWEEN THE RING AND OUTER SHELL OF BIPOLAR COMPONENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
CORRECTED DATA: H4: MANUFACTURE DATA: 5/22/96. SECTION F1-14: THIS SECTION HAS BEEN COMPLETED BY THE MANUFACTURER. ADDITIONAL INFORMATION HAS REQUESTED FROM THE USER FACILITY. SUMMARY OF EVALUATION: AS RECEIVED, THE ASSEMBLY IS OBSERVED TO BE IN GOOD CONDITION. INSPECTION OF THE RETURNED DEVICE REVEALED THERE IS SOME TOGGLE BETWEEN THE METAL SHELL AND THE POLYETHYLENE INSERT. DUE TO THE TOLERANCE REQUIREMENTS FOR THIS PRODUCT AND MEETS FINAL INSPECTION STANDARDS FOR THIS PRODUCT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE OBSERVED.
THE PUMP INDICATES THAT IT IS DELIVERING BUT THE ARM IS NOT PUSHING DOWN ON THE SYRINGE.
H3. THE DEVICE HISTORY WAS DOWNLOADED FOR REVIEW AND INDICATED THAT THE DEVICE HAD BEEN SET-UP TO DELIVER AT A VERY SLOW RATE (0.1615 ML/HR). SYRINGE PLUNGER MOVEMENT CANNOT BE DETECTED AT A RATE THIS SLOW. THEREFORE, IT MAY HAVE APPEARED TO THE USER THAT THE DEVICE WAS NOT DELIVERING. WHEN ACTUALLY IT WAS DELIVERING AS PROGRAMMED. THIS DEVICE DID NOT MALFUNCTION.
REPORTEDLY, ONE FREEZING CONTAINER WAS FOUND RUPTURED DURING THE THAWING PROCEDURE. THE CONTENTS OF THE CONTAINER, PERIPHERAL BLOOD STEM CELLS, WERE DISPOSED OF AT THE TIME OF THE EVENT. THE PT WAS NOT IMPACTED BY THE EVENT. SUFFICIENT BACK UP CELLS REMAINED TO TRANSPLANT THE PT. THE CONTAINER WILL BE RETURNED FOR EVAL. AT THE TIME OF THIS REPORT THE SAMPLE HAS NOT BEEN RECEIVED. THE CONTAINERS AFTER REMOVAL FROM THE LIQUID NITROGEN STORAGE TANK ARE EXTREMELY FRAGILE IN THIS FROZEN STATE. CARE MUST BE TAKEN WHEN HANDLING THE FROZEN PRODUCT NOT TO CAUSE ANY MECHANICAL DAMAGE TO THE PLASTIC CONTAINER. SMALL CRACKS OR FRACTURES IN THE BODY OF THE CONTAINER MAY CAUSE THE INGRESS OF LIQUID NITROGEN AND CAUSE THE RUPTURE OR DISTENTION OF THE CONTAINERS. FREEZING AND THAWING RECOMMENDATIONS ARE DISTRIBUTED WITH EACH MODEL NUMBER SOLD.
PRODUCT RECEIVED FOR EVALUATION 11/21/96. THE BAG WAS FOUND TO HAVE A LABEL ON IT. CUSTOMER WAS CONTACTED AND INSTRUCTED NOT TO PLEASE A LABEL ON THE BAG.
THIS UNIT STOPPED WITH NO ALARM WHILE VENTING A PT. AFTER REBOOTING, THE UNIT IS WORKING FINE. THE COMPLAINANT REMOVED THIS UNIT FROM SERVICE AND ROUTED THIS UNIT TO THE MFR FOR INVESTIGATION.
THE CAUSE OF THE REPORTED EVENT WAS TRACED TO AN INTERMITTENT FAILURE OF THE MAIN PCB OF THIS UNIT. THE MAIN PCB OF THIS UNIT WAS REPLACED AND THIS UNIT WILL BE RETURNED TO THE CUSTOMER.
NURSE EXPERIENCED LIGHTHEADEDNESS, ABDOMINAL CRAMPS, NAUSEA, DIARRHEA, CHEST TIGHTNESS, WHEEZING, TIGHTNESS IN THROAT, AND INTENSE ITCHING IN EARS AND THROAT AFTER OPENING A BOX OF POWDERED LATEX GLOVES. NURSE WAS LATER TREATED AND DIAGNOSED WITH LATEX ANAPHYLAXIS.
PRIOR TO A DIALYSIS TREATMENT, THERE WAS AN AUTOTEST FAILURE. THERE WAS NO PT INVOLVEMENT. REPORTED ON 8/22/96, DETERMINED TO BE MDR REPORTABLE ON 10/3/96.
A MES (MEDICAL EQUIPMENT SERVICE) TEDCH EXMAINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT INDIACTED THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 9/9/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED OL, INDICATING THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DIASSEMBLED AND IT WAS EEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MEL;TS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT.  IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR: NO. TRAINING REQUIRED? NO.
THE TIBIAL INSERT WOULD NOT LOCK IN THE BASEPLATE. ONCE IMPLANTED, THE SURGEON WAS ABLE TO REMOVE THE INSERT BY HAND. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
THE TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE ANTERIOR LOCKING TAB EXHIBITS DISTORTION DUE TO HAVING BEEN CRUSHED DURING THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFG. A QUERY OF THE PRODUCT EXPERIENCE REPORT DATABASE FOUND THAT NO OTHER SIMILAR EVENT HAD BEEN REPORTED FOR THIS LOT OF INSERTS. THE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES. IMPACTION OF A MISALIGNED INSERT DAMAGES THE ANTERIOR LOCKING TAB WHICH THEN PRECLUDES PROPER ASSEMBLY ONTO THE BASEPLATE.
SCISSORS BROKE OFF IN A PT DURING A PROCEDURE.
FURTHER REVIEW OF THIS COMPLAINT BY REGULATORY MANAGEMENT INDICATES THAT IT IS MORE APPROPRIATE TO CLASSIFY THE EVENT AS A "SERIOUS INJURY" RATHER THAN A MALFUNCTION. THIS FOLLOW-UP REPORT WAS SUBMITTED TO CORRECT THE INITIAL "MALFUNCTION" CLASSIFICATION. (THIS DEVICE WAS CLEARED UNDER K946239)
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT REMOVAL. THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE WAS REPLACED. REPORTED ON 7/15/96, DETERMINED TO BE MDR REPORTABLE ON 10/11/96.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE PART WAS RETURNED FOR INVESTIGATION ON 9/9/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED OL, INDICATING THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED  TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
THE TIBIAL INSERT WOULD NOT SEAT IN THE BASEPLATE. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
THE TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE ANTERIOR LOCKING TAB EXHIBITS DISTORTION DUE TO HAVING BEEN CRUSHED DURING THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFG. A QUERY OF THE PRODUCT EXPERIENCE REPORT DATABASE FOUND THAT NO OTHER SIMILAR EVENT HAD BEEN REPORTED FOR THIS LOT OF INSERTS. THE EVALUTION RESULTS, ALTHOUGH NOT CONCLUSIVE IN THE ABSENCE OF THE EVENT BASEPLATE, SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OP PROCEDURES.
THE PT PRESENTED IN DR'S OFFICE AND COMPLAINED OF "PAIN". ADDTIONALLY, IT WAS REPORTED THAT "NOTHING WAS WRONG WITH THE DEVICE". THE PHYSICIAN PRESCRIBED ANTIINFLAMMATORIES WITH FURTHER ACTION BEING PLANNED AT THIS TIME.
NO SURIGAL INTERVENTION HAS OCCURRED AS OF THE DATE OF THIS REPORT. A REQUEST HAS BEEN MADE TO THE PHYSICIAN'S OFFICE FOR ADDITIONAL INFORMATION SHOULD FURTHER MEDICAL OR SURGICAL INTERVENTION OCCUR. HOWEVER, BASED ON THE LIMITED INFORMATION RECEIVED, QA CONCLUDES THAT THE DEVICE FUNCTIONED AS INTENDED AND REMAINS IMPLANTED IN THIS PT. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THIS LABELING OR USUAL FOR THE SERVICE.
THE BALLOON OF THIS DEVICE WAS USED TO EXPAND ANOTHER MFR'S CORONARY STENT. THE BALLOON WAS PRESSURIEZED QUICKLY TO A PRESSURE GREATER THAN ITS RATED BURST PRESSURE. THE BALLOON IS REPORTED TO HAVE BURST WHILE EXPANDING THE CORONARY STENT. THERE WAS NO REPORT OF COMPLICATIONS OR INJURIES RELATED TO THIS EVENT.
MICROSCOPIC INSPECTION OF THE BALLOON'S SURFACE DID NOT REVEAL ABRASIONS. THE BALLOON OF THIS DEVICE BURST AT A PRESSURE GREATER THAN THE LABELED RATED BURST PRESSURE. THIS DEVICE WAS USED OUT OF INDICATION.
THE BALLOON OF THIS DEVICE BURST WHILE PERCORMING AN ANGIOPLASTY PROCEDURE ON A PROXIMAL RCA LESION. THE DEVICE WAS DISCARDED AND WILL NOT BE RETUREND.
NO PRODUCT RETURNED / EVENT COULD NOT BE VERIFIED.
BASED ON THE INFORMATION RECEIVED, QA ACCEPTS THE REPORT OF INFECTION AND SECONDARY EROSION AS THE CAUSE FOR THE SURGICAL INTERVENTION. IN ADDITION, BASED ON THE PROCEDURES BY WHICH THIS DEVICE LOT IS TESTED AND RELEASED, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO PACKAGE OPENING AND THAT THE INFECTION INITIATED FROM A SOURCE OR SOURCES OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
AS REPORTED TO CO, THE RT ROD ONLY WAS REMOVED.
THERE WAS AN AUTOTEST FAILURE DUE TO A FAULTY UF (ULTRAFILTRATION) PUMP THERMAL FUSE. THERE WAS NO PT INVOLVEMENT.
A MES(MEDICAL EQUIPMENBT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE PART WAS RETURNED FOR INVESTIGATION ON 10/8/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED OL, INDICATING THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISASSEMBLE AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSED THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSED THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT REFER TO FAR #960016. CUSTOMER CONTACTED NO.   SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRANING REQUIRED? N.
ER NURSE NOTED CRYSTALS IN BOTTLE OF STRIPS. APPARENTLY CAP OF VIAL CONTAINS SILICA GEL AND SOME CRYSTALS FELL OUT OF CAP AROUND EDGE OF INSIDE CAP COVER.
AT TIME OF DELIVERY, AFTER ONE PPV, THE BAG WOULD NOT INFLATE. WAS ABLE TO GIVE BLOW-BY OXYGEN ONLY. BABY DID NOT SUFFER ADVERSE OUTCOME.
DURING A DIALYSIS TREATMENT, THE FOUR POSITION LINE CLAMP BROKE.
DURING A DIALYSIS TREATMENT A FOUR POSITION LINE CLAMP BROKE. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THERE WERE NO RELATED CPF/DFT DEFECTS REPORTED. THE RETURNED FOUR-POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT THE CLAMP HOLDER WAS BROKEN. THE TABS ON THE WHITE CLAMP INSERT HOLDER WAS BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED:N. SALES/SERVICE CONTACTED BY INVESTIGATOR:N. TRAINING REQUIRED:N.
THERE HAVE BEEN NUMEROUS COMPLAINTS FROM CONSUMERS ON THE DULLNESS OF THE NEW POLYPROPYLENE HYPODERMIC NEEDLES. BOTH 25 GAUGE AND 26 GAUGE. IT HAS ALWAYS BEEN THE POLICY OF THIS CLINIC TO CHANGE THE NEEDLE AFTER DRAWING THE MEDICATION, TO INSURE SHARPNESS. THERE WAS NEVER A COMPLAINT WHEN USING A DIFFERENT BRAND NEEDLE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE 511S WHILE GASKET FELL INTO THE PT AND WAS RETRIEVED. THE CASE WAS ENDING AND ANOTHER TROCAR WAS NOT REQUIRED. THERE WAS NO CONSEQUENCE TO THE PT.
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
THERE HAVE BEEN NUMEROUS COMPLAINTS FROM CONSUMERS ON THE DULLNESS OF THE NEW POLYPROPYLENE HYPODERMIC NEEDLES, BOTH 25 GAUGE AND 26 GAUGE. IT HAS ALWAYS BEEN THE POLICY OF THIS CLINIC TO CHANGE THE NEEDLE AFTER DRAWING THE MEDICATION, TO INSURE SHARPNESS. THERE WAS NEVER A COMPLAINT WHEN USING ANOTHER BRAND OF NEEDLES.
DURING S DIALYSIS TREATMENT, IT WAS REPORTED THAT THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE FAILED. THERE WAS NO FURTHER INFO AVAILABLE. THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD.
FAILURE OF THE ULTRAFILTRATION (UF) PUMP THERMAL FUSE. NO FURTHER INFO AVAILABLE FROM THE FACILITY. A REVIEW OF THE DTF AND CPF HISTORIES IS NOT POSSIBLE SINCE THE MACHINE SERIAL NUMBER IS NOT KNOWN. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE TECHNICIAN AT THE FACILITY FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE FAILED THERMAL FUSE WAS NOT RETURNED FOR INVESTIGATION. IT HAS BEEN SEEN PREVIOUSLY THAT A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. THERE WERE TWO OTHER INCIDENTS REPORTED WITH THIS ONE. CUSTOMER CONTACTED:N. SALES/SERVICE CONTACTED BY INVESTIGATOR:N TRAINING REQUIRED:N.
THE DEVICE WAS USED DURING AN UNREPORTED PROCEDURE. THE 511S WOULD NOT ARM DURING THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D10-INFORMATION NOT PROVIDED BY USER FACILITY. D6,H8-INFORMATION NOT AVAILABLE. BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT "WOULD NOT ARM" DURING SURGERY. THE INSTRUMENT'S ENDCAP WAS DISASSEMBLED AND NO ANOMALIES OR DEFORMITIES WERE OBSERVED. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. APPROPRIATE ENGINEERING AND MFG PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.
PRIOR TO STARTING THE INFUSION AIR ENTERED THE TUBING THROUGH A HOLE IN THE SENSING DISC. THERE WAS NO ADVERSE EFFECT TO THE PT.
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
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFCIENT WEIGHT REMOVAL. THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE WAS REPLACED.
A MES(MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT THERE WAS ONE OTHER INCIDENT (CPF 1096112C3) CAUSED BY THE FAILURE INVESTIGATED IN THIS REPORT. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE EMS FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/15/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED 2.5 OHMS, INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSED THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT, REFER TO FAR #960016. CUSCOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? TRAINING ? N.
THE TUBING IS DEFECTIVE. THE PORTION OF THE IV TUBING THAT CONTAINS THE DRIP CHAMBER VENT SLIDE CLAMP IS MISSING FROM THE IV SET. THE DRIP CHAMBER IS OPEN TO THE ENVIRONMENT DUE TO THE MISSING IV TUBING. HOSP CONDUCTED AN EXAMINATION OF THIS LOT NUMBER OF IV TUBING THROUGHOUT THE HOSP. THE SEARCH FOUND AN ADD'L THREE SETS WITH THE SAME DEFECT UNOPENED IN THEIR ORIGINAL PACKAGING. A TOTAL OF FOUR IV SETS WERE FOUND WITH THE SAME DEFECT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE 512S WOULD ARM BUT WOULD NOT REACTIVATE WHEN REMOVED AND APPLIED AGAIN. A SECOND 512S WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
9/11/96 1105 MESSAGE AND 800# LEFT ON SURGEON'S ANSWERING MACHINE. KJB. 9/12/96 NNCL SENT. TSB. 9/12/97 1015 SPOKE WITH SOURCE WHO CONFIRMED THE INFO AS REPORTED BY THE SALES REP. SOURCE STATED SHE DID NOT KNOW ANY ADDITIONAL INFO SUCH AS PATIENT INFO. TSB. A1,2,3,4,B6,7,D10-INFO NOT PROVIDED BY USER FACILITY. H8-INFO NOT AVAILABLE.
A BROKEN BLOOD PUMP ROTOR SPRING WAS FOUND. THERE WAS NO PT INVOLVEMENT.
THE FACILITY WAS RECEIVING DIFFICULTIES WITH BLOOD FLOW THROUGH THE BLOOD TUBING SET DURING A DIALYSIS TREATMENT. THE MEDICAL EQUIPMENT SERVICE TECH (MES) FOUND A BROKEN BLOOD PUMP ROTOR SPRING. THE MES REPLACED THE BROKEN ROTOR AND FUNCIONALLY TESTED TO MANUFACTURING SPECIFICATIONS. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT BOTH SPRINGS ON THE ROTOR WERE BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT ONE OF THE SPRINGS BROKEN IN THREE PIECES AND THE OTHER SPRING BROKE IN FOUR PIECES.THE ABOVE INFO INDICATES THAT THE DIFFICULTIES THE FACILITY HAD WITH THE BLOOD FLOW AS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY TWO BROKEN ROTOR SPRINGS. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTIONS SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESIGATIONS, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED:N. SALES/SERVICE CONTACTED BY INVESTIGATOR?N. TRAINING REQUIRED:N.
THIS UNIT'S AUDIBLE ALARM DID NOT FUNCTION. THE COMPLAINANT RETURNED THIS UNIT TO THE MFR FOR REPAIR.
THE CAUSE OF THE REPORTED EVENT WAS TRACED TO A FAILURE OF THE ALARM CIRCUIT OF THE MAIN PCB OF THIS UNIT. THIS UNIT WAS REPAIRED AND THIS UNIT WILL BE RETURNED TO THE CUSTOMER.
IT WAS NOTICED THAT THE TUBING WAS NOT CONNECTED TO THE NEEDLE HUB WHILE ATTEMPTING TO OBTAIN A VENOUS BLOOD SAMPLE. SAMPLING OF SUSPENDED ITEMS FOUND NO OTHER DEFECTIVE DEVICES.
DURING SERVICE OF PRODUCT AN INTERMITTENT APNEA ALARM WAS FOUND DUE TO AN OUT OF CALIBRATION CONDITION. RECALIBRATED DEVICE.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGTH REMOVAL. THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE WAS REPLACED.
A MES(MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY OF THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT THERE WAS ONE OTHER INCIDENT (CPF 1096110C3) CAUSED BY THE FAILURE INVESTIGATED IN THIS REPORT. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/15/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED 2.5OHMS, INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
RESISTANCE WAS ENCOUNTERED DURING CATHETER PLACEMENT. THE CATHETER WAS PULLED BACK AND THE STYLET WAS SEEN TO HAVE EXITED THROUGH THE CATHETER WALL APPROX. 3/4THS OF THE WAY FROM THE PROXIMAL END.
THE DEVICE WAS DISCARDED BY THE HOSPITAL DUE TO SAFETY CONCERNS. A LOT HISTORY REVIEW INDICATED NO MANUFACTURING ISSUES AND NO OTHER PRODUCT COMPLAINTS OF SIMILAR NATURE REPORTED FOR THIS LOT.
OVERDELIVERY OF HEPARIN WAS REPORTED DUE TO THE MALFUNCTION OF THE PUMP. PT WAS NOT AFFECTED.
THE PHYSICIAN ATTEMPTED A RIGHT FEMORAL APPROACH FOR VENA CAVA FILTER PLACEMENT. AS HE ADVANCED THE FILTER THROUGH THE SHEATH, THE SHEATH KINKED NEAR THE ILIAC BIFURCATION. HE CONTINUED TO TRY TO ADVANCE THE FILTER, PUSHING UNTIL A HOOK ON THE LEG OF THE FILTER ENGAGED THE SHEATH, PREVENTING FURTHER ADVANCEMENT. HE THEN REMOVED THE SHEATH AND FILTER. HE ATTEMPTED TO PLACE ANOTHER MFR'S FILTER VIA THE SAME APPROACH AND THAT FILTER BROKE. A THIRD FILTER WAS SUCCESSFULLY PLACED THROUGH THE RIGHT FEMORAL APPROACH. THE PT REMAINS STABLE AND HAS SUFFERED NO ADVERSE EFFECTS FROM THE PROCEDURE.
NO RESULT FROM ANALYSIS CAUSES THE MFR TO BELIEVE THAT THE PROBLEM WAS DUE TO PRODUCT BEING OUT OF SPECIFICATION. THE MFR BELIEVES THAT THE PROBLEM WAS DUE TO THE ANATOMIC CONFIGURATION OF THE PATIENT. THE CURVES WERE TOO GREAT. THE PRODUCT EXCEEDED THE PHYSICAL LIMIT OF ITS USABILITY. #2 PAGES.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE STOPPED WORKING AND COULD NOT BE CALIBRATED.
SECTION A THROUGH F WERE COMPLETED BY THE MFR.
BLOOD LEAKAGE. DIALYZERS REUSED 1-5 TIMES. THE PTS ARE FINE. DISCARDED THE BLOOD IN THE BLOODLINE TUBING.
THE RETURNED UNIT FROM THE SAME LOT NUMBER WAS RETURNED TO THE FACTORY AND TESTED FOR PYROGENS, ACUTE TOXICITY, INTRACUTANEOUS TOXICITY AND HEMOLYSIS; NO ABNORMALITY WAS OBSERVED. STERILITY AND PYROGEN TESTS ARE ROUTINELY TESTED PRIOR TO SHIPMENT; THE RECORDS FOR THIS LOT WERE REVIEWED AND NO ABNORMALITY WAS OBSERVED.
DURING A DIALYSIS TREATEMENT, THERE WAS AN EXTERNAL LEAK AT THE SEALING PLUG ABOVE THE LABEL ON THE ARTERIAL END OF THE DIALYZER. RINSEBACK WAS COMPLETED SO THERE WAS NO BLOOD LOSS. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE AFFECTED PRODUCT WAS DISCARDED BY THE FACILITY AND THEREFORE, IS UNAVAILABLE FOR ANALYSIS, WITHOUT THE AFFECTED PRODURCT, IT IS DIFFICULT TO DETERMINE THE EXACT CAUSE OF THE REPORTED PROBLEM. IN ADDITION, THERE WAS NO ADDITIONAL PRODUCT AVAILABLE FROM THE ADDITIONAL PRODUCT AVAILABLE FROM THE FACILITY OR THE MFR'S WAREHOUSE FOR INVESTIGATION. THE HAZARD TO PT SAFETY OF AN EXTERNAL BLOOD LEAK IS DIRECTLY RELATED TO THE VOLUME OF THE BLOOD LOSS AND THE PT'S CURRENT OR PAST CLINICAL HISTORY. BASED ON RETROSPECTIVE REVIEW OF EXTERNAL BLOOD LEAK COMPLAINTS, THERE IS A LOW LIKELIHOOD THAT LOSS OF THE EXTRACORPOREAL BLOOD CIRCUIT WILL RESULT IN AN INJURY. IN ADDITION, THE BLOOD LOSS, AS IN THIS CASE, IS MINIMAL. WITHOUT THE AFFECTED PRODUCT FOR INVESTIGATION, IT IS DIFFICULT FOR THE MFR TO DETERMINE THE EXACT NATURE OF THE REPORTED PROBLEM. HOWEVER, THE MFR WILL CONTINUE TO MONITOR AND TREND. NO FURTHER REPORTING IS ANTICIPATED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT INDICATES THAT THE LOT WAS MANUFACTURED ACCORDING TO MFR'S SPECS. A REVIEW OF THE COMPLAINTS FOR THE REPORTED LOT SHOWS NO OTHER REPORTED INCIDENTS. CUSTOMER CONTACTED: NO. SALES/SVC CONTACTED BY INVESTIGATOR. NO. TRAINING REQUIRED? NO.
ON 8/6/96 WHILE CHEMOTHERAPY WAS INFUSING, BLOOD RETURN BECAME SLUGGISH. IT WAS LATER DETERMINED THAT THERE WAS A CHEMO EXTRAVASATION. CHEMO WAS STOPPED AND PHYSICIAN NOTIFIED. CATHETER WAS REMOVED LATER THE SAME DAY. WOUND CARE WAS GIVEN AND AREA ULTIMATELY HEALED. MAY HAVE BEEN PORT PROBLEM.
THE PHYSICIAN ATTEMPTED A RIGHT FEMORAL APPROACH FOR FILTER IMPLANTATION. UPON ADVANCING THE FILTER THROUGH THE INTRODUCER, THE PHYSICIAN MET RESISTANCE AT THE ILIOCAVAL JUNCTION. THE PT HAD A VERY SHARP ANGLE AT THIS JUNCTION. THE ENTIRE SYSTEM WAS THEN REMOVED AND A SECOND VENA CAVA FILTER WAS SUCCESSFULLY PLACED. THE PT REMAINS STABLE AND HAS SUFFERED NO ADVERSE EFFECTS FROM THE PROCEDURE.
DISCAIMER: B. BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, VOLUME 49, RELEASE NUMBER 180, DATED FRIDAY SEPTEMBER 14, 1984, SECTION 803 (MEDICAL DEVICE REPORTING) SUBSECTION 803.24. B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAS AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CAUSAL RELATIONSHIPS TO DEVICES MANUFACTURED OR DISTRIBUTED BY B. BRAUN MEDICAL INC.
THE DEVICE WAS USED DURING A PLASTIC NECK RECONSTRUCTION. IT WAS REPORTED THE MCM AND CLIPS SPIT FROM THE APPLIER. THE APPLIER WAS CLOSED ON A VESSEL WITHOUT CLIP IN THE JAWS AND CUT THE VESSEL. THE SURGEON TIED THE VESSEL WITH SUTURE TO COMPLETE THE PROCEDURE.
A1,2,3,4;B6,7;D10: INFO UNAVAILABLE: 9/4/96 1515 MESSAGE AND 800# LEFT FOR MD CALL BACK. 9/5/96 SURGEON RETURNED CALL. HE STATED THE CLIPS FROM THE MCM AND MCS SCISSORED AND CUT THE VESSEL IN HALF. HE STATED ON ONE INSTRUMENT 1 0R 2 IN A ROW DID THIS AND ON THE OTHER 2 OR 3 DID. HE STATED HE WAS ABLE TO COMPLETE THE CASE WITH THESE INSTRUMENTS. "GOOD" CLIPS FROM THESE APPLIERS WERE USED TO CONTROL THE BLEEDING. D5,6;H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
DURING A DIALYSIS TEATMENT, THERE WAS AN EXTERNAL BLOOD LEAK AT THE SEALING PLUG AT THE FRONT OF THE DIALYZER, ABOVE THE LABEL. THE BLOOD IN THE CIRCUIT WAS LOST. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE AFFECTED PRODUCT WAS DISCARDED BY THE FACILITY AND THEREFORE, IS UNAVAILABLE FOR ANALYSIS WITHOUT THE AFFECTED PRODUCT, IT IS DIFFCULT TO DETERMINE THE EXACT CAUSE OF THE  REPORTED PROBLEM. WITHOUT THE AFFECTED PRODUCT FOR FOR INVESTIGATION, IT IS DIFFICULT FOR THE MFR TO DETERMINE THE EXACT NAURE OF THE REPORTED PROBLEM, HOWEVER, THE MFR WILL CONTINUE TO MONITOR AND TREND. NO FURTHER REPORTING IS ANTICIPATED.
DURING PROCEDURE, THE HOSPITAL STAFF REPORTED THAT THE AIR OUTPUT TURNED OFF BY ITSELF AND THE SYSTEM WAS CHANGED OUT TO COMPLETE THE CASE.
UNIT WAS SUBJECTED TO EXTENDED PERIODS OF BURN-IN AND OPERATION. IT WAS FURTHER TESTED FOR SUSCEPTIBILITY TO RADIATED ELECTROMAGNETIC INTERFERNECE (EMI) AND SUSCEPTIBILITY TO ELECTRICAL FAST TRANSIENT (EFT) IN A LABORATORY ENVIRONMENT. THE UNIT PASSED TESTING AT THE LEVELS CALLED FOR IN THE EUROPEAN STANDARD(EN60601-1-2). THE FAILURE WAS DUPLICATED IN ONE INSTANCE AT MORE THAN THREE TIMES THE LEVEL CALLED FOR IN THE EUROPEAN STANDARD. CONCLUSIONN IS THAT THE INCIDENT WAS MOST LIKELY TO HAVE BEEN CAUSED BY A VERY HIGH LEVEL OF ELECTROMAGNETIC INTERFERNCE. ACTION: UNIT WILL BE UPGRADED TO CURRENT REVISION WHICH INCLUDES IMPROVED SHIELDING. RECOMMEND PRECAUTIONS TO USER TO MINIMIZE POTENTIAL EXPOSURE TO EMI.
TRANSFERRING THE PT FROM HIS BED TO CHAIR. APPROX 5" TO 6" ABOVE THE CHAIR SEAT THE YOKE BOLT/PIN BROKE, LETTING THE PT FALL INTO THE CHAIR, PT WAS UNINJURED. ONE PERSON INVOLVED.
THIS LIFT WAS OVERLOOKED IN THE UPGRADE PROGRAM INITIATED 6/28/94 WHICH REPLACED THE HANGER. A TECHNICIAN TOOK THIS UNIT OUT OF SERVICE AND A WORK ORDER WAS INITIATED ON 9/11/96. UNIT HAS BEEN SATISFACTORILY UPDATED AND COMPLETED, AN ACKNOWLEDGEMENT OF THIS IS IN THE FILE.
DURING A DIALYSIS TREATMENT, THERE WAS AN EXTERNAL BLOOD LEAK AT THE SEALING PLUG AT THE FRONT OF THE DIALYZER, ABOVE THE LABEL. THE BLOOD IN THE CIRCUIT WAS LOST. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE AFFECTED PRODUCT WAS DISCARDED BY THE FACILITY AND THEREFORE, IS UNAVAILABEL FRO ANALYSIS. WITHOUT THE AFFECTEDF PRODUCT,IT IS DIFFICULT TO DETERMINE THE EXACT CAUSE FOF THE REPORTED PROBLEM. THE HAZARD TI OT SAFETY OF AN EXTERNAL BLOOD LEAK IS DIRECTLY RELATED TO THE VAOLUME OF THE BLOOD LOSS AND THE PT'S CURRENT OR PAST CLINICAL HISTORY. BASED ON RETROSPECTIVE REVIEW OT EXTERNAL BLOOD LEAK COMPLAINTS, THERE IS A LOW LIKELIHOOD THAT LOSS OF THE EXTRACORPOREAL BLOOD CIRCUIT WILL REUSLT IN AN INJURY. IN ADDITION, THE BLOOD LOSS, AS IN THIS CASE, IS MINIMAL. WITHOUT THE AFFECTED PRODUCT FOR INVESTIGATION, IT IS DIFFICULT FOR THE MFR TO DETERMINE THE  EXACT NAUTE OF THE REPORTED PROBLEM. HOWEVER, THE MFR  WILL CONTINUE TO MONITOR AND TREND. NO FURTHER REPORTING IS ANTICIPATED. A REVIEW FO THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT INDICATESF THAT THE LOT WAS MANUFACTURED ACCORDING TO MFR'S SPECIFICATIONS. CUSTOMER CONTACTED: NO,  SALES/SERVICE COANTACTED BY INVESTIGATOR: NO, TRAINING REQUIRED: NO.
THIS REPORT REPRESENTS A LAWSUIT FILED BY A SINGLE LAW FIRM AGAINST A MEDICAL PRACTICE, THE HOSP AND CO. THE PLAINTFIF AND ATTORNEY HAD ALLEGED PERMANENT PHYSICAL IMPAIRMENT (DEFINED IN 21 CFR PART 803.3 AS A SERIOUS INJURY) AND DISABILITY, AND PAIN, SUFFERING AND MENTAL ANGUISH IN A PT WHO WAS IMPLANTED WITH THE DEVICE DURING ANTERIOR CERVICAL DISECTOMY. USE OF THIS DEVICE IN ANTERIOR CERVICAL DISECTOMY PROCEDURE IS NOT RECOMMENDED BY THE MFR. THE CO HAS DENIED THE ALLEGATIONS AND DOES NOT BELIEVE THAT THE COMPLAINT REPRESENTS A REPORTABLE EVENT. HOWEVER, TO ER  ON THE SIDE OF CAUTION, THIS REPORT IS BEING MADE.
H6 -PART NOT RETURNED, LOT NUMBER NOT AVAILABLE. H1 -ALLEGED INJURY IN CONTEXT OF LAWSUIT. THIS REPORT AND THE INFO CONTAINED HEREIN IS SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION UNDER 21 CFR PART 803 AND REPRESENTS THE INFO AVAILABLE TO THE CO AT THE TIME OF THE REPORT. THE REPORT DOES NOT CONSTITUTE AN ACKNOWLEDGEMENT THAT THE EVENT REPORTED THEREIN OCCURRED, THAT THE INFO IS ACCURATE IN ANY RESPECT, OR THAT THE CO WAS NEGLIGENT OR RESPONSOBLE FOR ANY WRONGDOING AND IT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE IS DEFECTIVE, OR THAT THE DEVICE MALFUNCTIONED OR OTHERWISE FALLED TO PERFORM IN ANY MANNER, OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN INJURY OR A DEATH. H-7 CO REACHED A VOLUNTARY AGREEMENT WITH THE AGENCY TO UNDERTAKE A PT FOLLOW-UP PROGRAM. BY LETTER OF 10/4/96, THE AGENCY DEEMED THE PROGRAM TO BE SATISFACTORILY COMPLETE.
IMPLANT FAILED AND HAD TO BE REMOVED. EXACT DATE OF OCCURRENCE IS UNK.
ADD'L INFO WAS RECEIVED 9/16/96. THIS INFO INDICATES THAT INFECTION WAS PRESENT. AS THE IMPLANT WAS FOUND TO MEET SPECS, THE INFECTION IS THE PROBABLE CAUSE OF FAILURE.
A 285 LB PT DID NOT COOL IMMEDIATELY. THE PT STAYED AT 62 DEGREES FOR 15 MINS. THE COLOR OF BLOOD BECAME CONCERNING, DREW BLOOD GAS SWEEP RATE 6.4 ON BYPASS FI02 85% (P02 WAS 40MMHG). 15 MIN AT NORMOTHERMIA INCREASE FI02 TO 100% BLOOD GAS DRAWN AGAIN P092 WAS 40 MMHG SO CHANGED UNIT TO ANOTHER CXSX18. NO PROBLEMS WERE NOTED WITH THE NEW OXYGENATOR. THE PT WAS FINE.
THE RETURNED UNIT WAS VISUALLY EXAMINED; NO ABNORMALITY WAS OBSERVED. THE UNITS WERE TESTED FOR OXYGEN TRANFER; RESULTS WERE WITHIN SPEC. THE ROUTINE MANUFACTURING QUALITY CONTROL RECORDS WERE REVIEWED AND NO ABNORMALITY WAS OBSERVED. NO CAUSE FOR THIS OCCURRENCE COULD BE IDENTIFIED.
A1,2,3,4;B6,7;D10: INFO UNAVAILABLE. 9/4/96 1515 MESSAGE AND 800# LEFT FOR MD CALL BACK. 9/5/96 SURGEON RETURNED CALL. HE STATED THE CLIPS FROM THE MCM AND MCS SCISSORED AND CUT THE VESSEL IN HALF. HE STATED ON ONE INSTRUMENT 1 OR 2 IN A ROW DID THIS AND ON THE OTHER 2 OR 3 DID. HE STATED HE WAS ABLE TO COMPLETE THE CASE WITH THESE INSTRUMENTS. "GOOD" CLIPS FROM THESE APPLIERS WERE USED TO CONTROL THE BLEEDING. D5,6;H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
A 17-YR-OLD FEMALE WENT TO BED AFER A NORMAL EVENING. WOKE UP TO USE THE BATHROOM AROUND 3 OR 4 AM. SHE WAS FOUND DEAD THE NEXT DAY. HOSPITALIZATION AT THE TIME OF IMPLANTATION WAS PROLONGED DUE TO A COLLAPSED LUNG AND A LEAD CAME LOSE. A DIFFERENT LEAD WAS LEFT IN PERMANENTLY BECAUSE IT COULD NOT BE REMOVED FROM THE APEX.
SUTURE SPLIT DURING THE OPERATION. THE DOCTOR STATED, "THAT HE HAD TO INTERRUPT HIS WORK TO PREPARE ANOTHER SUTURE DURING SUCH AN IMPORTANT ANASTOMOSES". NO OTHER INFO WAS GIVEN.
INVESTIGATION IS IN PROGRESS. REFERENCE MFR. COMPLAINT G96-170. PLEASE NOTE THAT THIS REPORT MAY BE BASED GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
EXPLANTED TISSUE EXPANDER DUE TO LEAKAGE.
PUMP DID NOT INFUSE THE CORRECT AMOUNTS OF FLUIDS. WHEN PERFORMING A FLUID CHECK ON THE PUMP, IT OVER PUMPED AND INFUSED AT THE WRONG RATE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS BEGAN TO SCISSOR ON THE FIRST FIRING. A SECOND WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D5,6,10,H4-INFO NOT PROVIDED. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED WITH YEILDED JAWS. THERE WERE THREE CLIPS RETURNED IN A SEALED CONTAINER. ONE OF THE CLIPS WAS CONFORMING, ONE WAS PARTIALLY FORMED, AND THE LAST CLIP WAS UNFORMED. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THE INSTRUMENT WAS DISASSEMBLED AND WAS FOUND TO HAVE A DETACHED FORMER PLATE. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
TIP SEPARATED FROM RESECTOSCOPE INNER SHEATH DURING ENDOMETRIAL ABLATION.
THE PROBLEM MOST LIKELY OCCURRED DUE TO IMPROPER ASSEMBLY OR DISASSEMBLY OF THE CFR INNER AND OUTER STREAM AUTOCLAVING COUNTER TO LABELING INSTRUCTIONS.
A FILTER DID NOT COMPLETELY OPEN AFTER DEPLOYMENT VIA THE JUGULAR APPROACH. A SECOND FILTER WAS SUCCESSFULLY PLACED WITH NO PT COMPLICATIONS. THIS DEVICE REMAINS IMPLANTED AND WILL NOT BE AVAILABLE FOR EVALUATION. IT WAS INDICATED A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO FILTER PLACEMENT AND CONTINUAL FLUSHING OF THE CARRIER SYSTEM DURING THE IMPLANT PROCEDURE WAS NOT PERFORMED WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "AN INFERIOR VENA CAVOGRAM MUST BE PERFORMED PRIOR TO VENA CAVA FILTER INSERTION. THIS PROCEDURE DETERMINES CAVAL PATENCY AND DIAMETER AND IS USED TO EVALUATE THE INFERIOR VENA CAVA FOR THE PRESENCE OF THROMBUS AND CONGENITAL ANOMALIES...DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER...IN MOST CASES, A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE...THE INTRODUCER CATHETER MUST BE FLUSHED THROUGH THE FLUSH PORT BY FREQUENT INJECTION OR CONTINUOUS INFUSION OF STERILE HEPARINIZED SALINE DURING THE IMPLANT PROCEDURE...INSUFFICIENT FLUSHING CAN ALLOW THROMBUS FORMATION INSIDE THE VENA CAVA FILTER WHICH CAN BIND THE LEGS AND PREVENT COMPLETE OPENING UPON RELEASE."
TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP STROKE VOLUME TO BE INCORRECT DUE TO THE LOCK-NUT BEING LOOSE. THE UF PUMP STOKE LENGTH MUST REMAIN FIXED SO THAT THE PUMP WILL PUMP A VOLUME BETWEEN 80-120 ML, PER 200 STROKES. SINCE THE LOCK-NUT WAS LOOSE, THE STROKE OF THE PUMP WAS SHORTENED AND THE PUMP VOLUME PER 200 STROKES HAD CHANGED. THE UF PUMP'S STROKES WERE ADJUSTED BACK INTO SPEC AND THE LOCK-NUT WAS SECURED. UF PUMP WAS THEN RE-CALIBRATED TO NEW LOCK-NUT POSIITON. SINCE RE-SECURING LOCK-NUT SOLVED PROBLEM, NO PART WAS RETURNED FOR INVESTIGATION. FOLLOWING ANALYSIS DEMONSTRATES THAT REPORTED PROBLEM WAS DUE TO LOOSENING OF LOCK-NUT. WT TO BE REMOVED ACTUAL 4.1 KG. IDEAL CALIBRATION VALVE 200 ML. ACTUAL WT REMOVED 1.8 KG. ACTUAL CALIBRATION VALUE 73 ML. RATIO, 2.3, RATIO, 2.7. THERE ARE SEVERAL FACILITY PRACTICES THAT CAN AFFECT ACCURACY OF TREATMENT, SUCH AS INACCURATE PRE & POST WTS, PT EATING & DRINKING DURING TREATMENT, & FAILURE TO ACCOUNT FOR FLUID ADDED DURING RINSEBACK. THESE ARE TYPICALLY INSIGNIFICANT AMOUNTS TO PT, BUT WOULD HELP ACCOUNT FOR SLIGHT DIFFERENCE IN RATIOS. FACILITY TECH NOTICED THAT LOCK-NUT WAS LOOSE. IT IS UNKNOWN HOW THE LOCK-NUT LOOSENED. MACHINE HAS OPERATED 18,105 HRS IN FIELD, SO IT IS POSSIBLE THAT LOCK-NUT WAS LOOSENED DURING MAINTENANCE TO UF PUMP. IT IS CONCLUDED THAT REPORTED INCIDENT WAS CAUSED BY LOCK-NUT ON UF PUMP BEING LOOSE, WHICH CHANGED UF PUMP STROKE VOLUME. REVIEW OF CPF HISTORY ON 10/15/96, SHOWS THAT THERE HAVE BEEN NO FURTHER INCIDENTS OF THIS NATURE, INDICATING THAT CONDITION WAS CORRECTED BY THE ACTION TAKEN. SAFETY ANALYSIS: TO HELP VERIFY UF SYSTEM INTEGRITY, IT IS RECOMMENDED IN DEVICE'S OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED PRIOR TO 1ST TREATMENT OF DAY, IF MACHINE HAS BEEN TURNED OFF, IF A PT WT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10). OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF CALCULATED VALVE TO ACTUAL VALUE AFTER TREATMENT BEGINS. THIS VERIFIES THAT UF RATE IS AS EXPECTED. FOLLOWUP ACTION: IT IS CONCLUDED THAT CHANGE IN UF PUMP'S STROKE WAS DUE TO LOOSE LOCK-NUT, CAUSING REPORTED INCIDENT. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF CO'S CORRECTIVE ACTION SYSTEM & MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY & DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED: N. SALES/SVC CONTACTED BY INVESTIGATOR? Y. DATE 10/16/96. TRAINING REQUIRED? N. REPORT ATTACHED? Y.
SUTURE EASILY BROKE DURING OPERATION. THE SUTURE BROKE DURING THE BLALOCK-TAUSSING  SHUNT OPERATION. THE SAME THING OCCURRED WITH FOUR SUTURES. THERE WAS NO SIGNIFICANT DELAY IN THE SURGICAL PROCEDURE. THERE WAS NO EXCESSIVE BLEEDING, AND THE BREAKAGE DID NOT CAUSE ANY BREAKDOWN OF THE ANASTAMOSIS. RESUTURING WAS NOT REQUIRED. THE SUTURE WAS USED IN THE SUBCLAVIAN TO PULMONARY ARTERY ANASTOMOSIS.
NO SUTURE SAMPLES WERE RECEIVED FROM THE COMPLAINANT. SUTURE KNOT PULL STRENGTH TESTING WAS PERFORMED ON RETAINED SAMPLES FROM EACH LOT. RESULTS COMPARED FAVORABLY WITH IN-PROCESS AND FINAL RELEASE DATA AND FOUND TO BE IN COMPLIANCE WITH INTERNAL STANDARD OPERATING PROCEDURES AND USP SPECIFICATIONS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED AGAINST THESE TWO LOTS SINCE THEIR RELEASE.
THIS REPORT REPRESENTS A LAWSUIT FILED BY A SINGLE LAW FIRM AGAINST A MEDICAL PRACTICE, THE HOSP AND CO. THE PLAINTIFF'S ATTORNEY HAS ALLEGED PERMANENT PHYSICIAL IMPAIRMENT (DEFINED IN 21 CFR.3 AS A SERIOUS INJURY) AND DISABILITY, AND PAIN, SUFFERING AND MENTAL ANGUISH IN A PT WHO WAS IMPLANTED WITH THE DEVICE DURING ANTERIOR CERVICAL DISECTOMY. USE OF THIS DEVICE IN ANTERIOR CERVICAL DISECTOMY PROCEDURE IS NOT RECOMMENDED BY THE MFR. THE CO HAS DENIED THE ALLEGATIONS AND DOES NOT BELIEVE THAT THE COMPLAINT REPRESENTS A REPORTABLE EVENT. HOWEVER, TO ER ON THE SIDE OF CAUTION, THIS REPORT IS BEING MADE.
H6 -PART NOT RETURNED, LOT NUMBER NOT AVAILABLE. H1 -ALLEGED INJURY IN CONTEXT OF A LAWSUIT. THIS REPORT AND THE INFO CONTAINED HEREIN IS SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION UNDER 21 CFR PART 803 AND REPRESENTS THE INFO AVAILABLE TO THE CO AT THE TIME OF THE REPORT. THE REPORT DOES NOT CONSTITUTE AN ACKNOWLEDGMENT THAT THE EVENT REPORTED HEREIN OCCURRED, THAT THE INFO IS ACCURATE IN ANY RESPECT, OR THAT THE CO WAS NEGLIGENT OR RESPONSIBLE FOR ANY WRONGDOING AND IT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE IS DEFECTIVE, OR THAT THE DEVICE MALFUNCTIONED OR OTHERWISE FAILED TO PERFORM IN ANY MANNER, OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN INJURY OR DEATH. H7 -CO REACHED A VOLUNTARY AGREEMENT WITH THE AGENCY TO UNDERTAKE A PT FOLLOW-UP PROGRAM. BY LETTER OF 10/4/96, THE AGENCY DEEMED THE PROGRAM TO BE SATISFACTORILY COMPLETE.
DOPAMINE DRIP STARTED AT RATE OF 0.3 CC/HR USING INFUSION PUMP. TWENTY MINS LATER, NEWBORN'S BLOOD PRESSURE WAS 140/117. DOPAMINE DRIP STOPPED. TOTAL VOLUME INFUSED IN 20 MINS WAS 0.7 CC. NEWBORN'S BLOOD PRESSURE RETURNED TO NORMAL.
510 K #950928. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? UNK. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSSED INT HE DEVICE LABELING? NO. IS SEVERITY GREATER FOR THIS  EVENT THAN IS USUAL? UNK.
DURING DIRECTIONAL CORONARY ATHERECTOMY (DCA) OF A CALCIFIED LESION, EIGHT PASSES WERE MADE AT 1 ATM. THE BALLOON WAS THEN INFLATED TO 2 ATMS FOR TWO MORE ADD'L PASSES. AT THAT TIME, THE CUTTER BACK INTO THE HOUSING WINDOW. THE PHYSICIAN RETRACTED THE CUTTER BACK INTO THE HOUSING WINDOW AND SAFELY REMOVED THE DEVICE FROM THE PT. THE CASE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT. THE DCA DEVICE WAS USED IN A CALCIFIED LESION WHICH ITS INSTRUCTIONS FOR USE CONTRAINDICATED.
THE DEVICE WAS RECEIVED FOR EVAL ON 9/6/96 AND ANALYSIS CONFIRMED THAT THE CUTTER HAD EXITED THE HOUSING WINDOW. BURR/NICKS WERE NOTED ON THE HOUSING WINDOW. THE DEVICE WAS USED IN CONDITIONS THAT ARE CONTRAINDICATED IN THE INSTRUCTIONS FOR USE. THE CORRECTIVE ACTION FOR THIS TYPE OF INCIDENT WILL BE RETRAINING OF THE PRACTITIONERS ON THE PROPER USAGE OF THE DEVICE.
THE USER FACILITY HAS DECIDED THAT EVEN THOUGH THEY WERE UNABLE TO FIND ANY PROBLEM WITH THE PUMP THEY ARE NOT GOING TO RETURN IT TO THE MFR FOR ANY FURTHER EVALUATION. THEY HAVE DECIDED NOT TO USE THE PUMP AND HAVE PUT INOT STORAGE.
BREATHING CIRCUIT DEVELOPED A SIGNIFICANT LEAK DURING INTRAOP. CIRCUIT CAN PASS MFR'S LEAK TEST BEFORE USE ON A PT, HOWEVER, IF CORRUGATED TUBING IS BENT, THE TUBING'S "LEAKAGE HOLES" (WHICH SHOULD NOT BE PRESENT) ARE OPENED, ALLOWING GAS TO LEAK OUT OF THE CIRCUIT DURING SURGERY. THIS PRODUCT HAS BEEN FOUND TO LEAK DURING INTRAOP AFTER PASSING A PRE-OP LEAK TEST, AS WELL AS SIMPLY FAILING THE PRE-OP LEAK TEST. AT LEAST 15 DEFECTIVE UNITS HAVE BEEN ENCOUNTERED FROM (3) DIFFERENT LOT NUMBERS.
ACTUAL DEVICE INVOLVED IN INCIDENT WAS NOT RETURNED. HOWEVER, CO RECEIVED SIX (6) SAMPLES (PRIOR TO THIS EVENT) OF THE SAME DEVICE FROM THE SAME LOT NUMBER IN QUESTION. THESE SAMPLES WERE RETURNED ON 9/18/96 AND IDENTIFIED BY CO'S LOCAL REP. FOR THIS USER FACILITY AS CONTAINING PIN HOLES WHICH COULD POSSIBLY CAUSE A CIRCUIT TO LEAK. LEAK TESTS WERE PERFORMED ON TWO OF THE SIX THAT CONTAINED PIN HOLES. CO FOUND THAT BOTH CIRCUITS LEAKED IN EXCESS OF CO'S ESTABLISHED CRITERIA. THE HOSES WERE FOUND TO LEAK WHEN TESTED IN EITHER THE "STRAIGHT" OR "BENT" ORIENTATION. THIS FINDING DOES NOT AGREE WITH THE USER'S CLAIM THAT THE LEAK WAS NOT DETECTED DURING "PRE-OP" LEAK TESTING (AS DIRECTED BY CO'S PRODUCT POLYBAG LABEL AND THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS). VISUAL EXAM OF BOTH CIRCUITS SHOWED SIMILAR DEFECT CHARACTERISTICS (PIN HOLES IN SPECIFIC LOCATION OF CORRUGATED HOSE). THE DEFECT IS NOT CONSIDERED TO REPRESENT A SIGNIFICANT HEALTH HAZARD BUT COULD CAUSE A MINOR DELAY IN INITIATING AN ANESTHESTIC PROCEDURE. CO HAS INITIATED A RECALL AFFECTING A LIMITED VINTAGE OF ADULT BREATHING CIRCUITS IDENTIFIED AS CONTAINING THE SUSPECT CORRUGATED HOSE IN QUESTION.
THE THREE  INSTRUMENTS WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIP APPLIERS MISFIRED DURING STANDARD LAP CHOLE PROCEDURE. CASE WAS COMPLETED WITH A FOURTH INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
CO #964653. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS OF INSTRUMENTS A&B HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENTS NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IT WAS CONCLUDED THAT INSTRUMENT C WAS RETURNED WITH NO PRELOAD OF THE JAW AGAINST THE TOP SHROUD. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
INITIALLY, LEFT LATERAL PATHWAY WAS SUSPECTED. BUT THE DIAGNOSTIC PROCEDURE REVEALED THAT THE PATHWAY WAS ON THE RIGHT SIDE. THE SUBJECT DELFECTABLE CATHETER WAS THEN USED TO ABLATE. THE RADIOFREQUENCY ENERGY OF 15 WATTS WAS APPLIED SEVERAL TIMES WITHOUT SUCCESS. AT THE TIME THE CATHETER WAS WITHDRAWN, THE TIP ELECTRODE WAS LEFT INSIDE THE PT'S HEART, POSSIBLY THE MYOCARDIUM. ANOTHER DEFLECTABLE CATHETER WAS USED TO FINISH THE CASE. THE PT WAS DISCHARGED FORM THE HOSP WITHOUT FURTHER TREATMENT.
THE DATA ARE UNAVAILABLE TO DETERMINE IF THE EVENT OCCURRED OR IS OCCURING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE DEVICE LABELING OR THAT IS USUAL FOR THIS DEVICE. TIP WAS LEFT INSIDE A PT'S     HEART. CATHETER HAD BEEN USED. PRODUCT WAS NOT DECONTAMINATED. THE CATHETER WAS DECONTAMINATED AT CO. THE TIP ELECTRODE WAS MISSING. TIP ELECTRODE WAS MISSING. THERE APPEARED TO BE AN ADEQUATE AMOUNT OF PU. PU WAS FLAIRED AT THE TIP. BOTH SAFETY WIRES WERE BROKEN JUST DISTAL TO THE BOTTOM OF THE TREPAM. IT APPEARED THAT THERE WERE ENOUGH WRAPS AROUND THE TIP ELECTRODE STEM (THIS WAS DETERMINED BY THE FOOTPRINT LEFT IN THE DUAL LUMEN). COMPLAINT CONDITION WAS CONFIRMED.
DURING A LAMINECTOMY, TWO BURS BROKE IMMEDIATELY AFTER TOUCHING THE BONE. THE DR WAS ABLE TO RETRIEVE BOTH BURS.
ALL INFO TO COMPLETE SECTIONS A, B, D, E, & F WAS OBTAINED BY CO REGULATORY COMPLIANCE.
FILTER PRO SYRINGE TIP BLEW OFF SYRINGE WHEN TECHNICIAN WAS EXPELLING AIR BUBBLE FROM SAMPLE. THE BLOOD SPRAYED ON TECHNICIAN & EQUIPMENT.
THE BALLOON OF THIS DEVICE BURST WHILE PERFORMING AN ANGIOPLASTY PROCEDURE ON A PROXIMAL RCA LESION. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.
THIS REPORT REPRESENTS A LAWSUIT FILED BY SINGLE LAW FIRM AGAINST A MEDICAL PRACTICE, THE HOSP AND CO. THE PT'S ATTORNEY HAD ALLEGED PERMANENT PHYSICIAL IMPAIRMENT (DEFINED IN 21 CFR PART 803.S AS A SERIOUS INJURY) AND DISABILITY, AND PAIN, SUFFERING AND MENTAL ANGUISH IN A PT WHO WAS IMPLANTED WITH THE DEVICE DURING ANTERIOR CERVICAL DISECTOMY. USE OF THIS DEVICE IN ANTERIOR CERVICAL DISECTOMY PROCEDURE IS NOT RECOMMENDED BY THE MFR. THE CO HAS DENIED THE ALLEGATIONS AND DOES NOT BELIEVE THAT THE COMPLAINT REPRESENTS A REPORTABLE EVENT. HOWEVER, TO EN  ON THE SIDE OF CAUTION, THIS REPORT IS BEING MADE.
H6 -PART NOT RETURNED, LOT NUMBER NOT AVAILABLE. H1 -ALLEGED INJURY IN CONTEXT OF A LAWSUIT. THIS REPORT AND THE INFO CONTAINED HEREIN IS SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION UNDER 21 CFR, PART 803 AND REPRESENTS THE INFO AVAILABLE TO THE CO AT THE TIME OF THE REPORT. THE REPORT DOES NOT CONSTITUTE AN ACKNOWLEDGMENT THAT THE EVENT REPORTED THEREIN OCCURRED, THAT THE INFO IS ACCURATE IN ANY RESPECT, OR THAT THE CO WAS NEGLIGENT OR RESPONSIBLE FOR ANY WRONGDOING AND IT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE IS DEFECTIVE, OR THAT THE DEVICE MALFUNCTIONED OR OTHERWISE FAILED TO PERFORM IN AY MANNER, OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN INJURY OR A DEATH. H7 -CO REACHED A VOLUNTARY AGREEMENT WITH THE AGENCY TO UNDERTAKE A PT FOLLOW-UP-PROGRAM. BY LETTER OF 10/4/96, THE AGENCY DEEMED THE PROGRAM TO BE SATISFACTORILY COMPLETE.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FOOD AND DRUG ADMIN BY SIMS, INC. PURSUANT TO 21 C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AN ADMISSION BY THE CO THAT A SIMS DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. FOLLOW-UP WITH RISK MANAGEMENT REVEALS THEY DO NOT HAVE A REPORT #. CODE 1563-FOLLOW-UP WITH RISK MANAGEMENT REVEALS THIS CODE IS NOT APPLICABLE FOR THIS EVENT. CODE 1160-CORRECTED TO 1161-NOT LABELED ALTHOUGH UNCONFIRMED BY RISK MANAGEMENT, CO WAS INFORMED THAT THE TECHNICIAN WAS PREGNANT AND WAS EXPOSED TO HEPATITIS C INFECTED BLOOD. D9. FOLLOW-UP WITH RISK MANAGEMENT REVEALS THAT THE DEVICE MAY BE RETURNED FOR EVALUATION. METHOD, CODE 86 OTHER: REVIEW OF DEVICE HISTORY RECORD FOR THE KIT AND THE FILTER-PRO LOTS INVOLVED IN THIS EVENT REVEAL THAT NO PROBLEMS WERE NOTED DURING PRODUCT MANUFACTURE. REVIEW OF CO'S COMPLAINTS DATABASE REVEALS THAT NONE OF THE LOTS INVOLVED IN THIS EVENT HAVE BEEN INVOLVED IN ANY SIMILAR EVENTS. RESULTS, USE OF DEVICE, CODE 200 OTHER CO'S REVIEW REVEALS THE CO'S LABELING CONTAINS ADEQUATE INSTRUCTIONS FOR USE. CO HAS DETERMINED THAT THIS EVENT IS VERY LIKELY PROCEDURAL RELATED.
LEAD WAS REMOVED FROM SERVICE. AN INVASIVE PROCEDURE WAS PERFORMED TO REMOVE THE LEAD DUE TO A FLUID INSIDE THE INSULATION. THE LEAD WAS REPLACED WITH A NEW BIPOLAR LEAD.
PT WAS SUPPOSED TO BE ON FIO2-100%. HOWEVER, O2 WAS ANALYZED AT 80-85%. THE FLOW METER WAS TURNED TO FLUSH BUT WOULD ONLY READ 4 TO 5 LPM. THE NEBULIZER WAS CHANGED AND RE-ANALYZED AT 92-93%. PT'S SATURATION INCREASED FROM 92 TO 97% WITH THE CHANGE. PT'S ABG IMPROVED. HIS PO2 WAS 71 AND INCREASED TO 92.
THE REPORTED DEVICE IS INTENDED TO DELIVER FI02 WITHIN THE RANGE OF 28% TO 60% O2, AS IS INDICATED ON THE PRODUCT'S FIO2% CONTROL DIAL, AT A FLOW RATE OF 20 TO 68 LITERS PER UNIT (LPM). ADD'L OTHER PRODUCT NUMBERS AND/OR OPTIONS ARE AVAILABLE THAT ARE INTENDED TO DELIVER FIO2 UP TO 100% O2 FLOW RATES UP TO 100 LPM. CO'S INVESTIGATION HAS CONCLUDED THAT SOME BLACK PARTICULATE-FOREIGN MATTER PARTIALLY OCCLUDED THE "BERNOULLI JET" APERTURE THROUGH WHICH AIR FLOW IS CRITICAL TO ALLOW PROPER DEVICE FUNCTION. THIS CONDITION CAUSES OBVIOUS UNACCEPTABLE O2 CONCENTRATION AND/OR FLOW RESULTS. THE FOREIGN MATTER WAS FOUND TO EXIST ON THE INLET SIDE OF THE "JET" AND MOST LIKELY TO HAVE ORIGINATED FROM THE USER FACILITY'S CONNECTED AIR (OXYGEN) SOURCE. THIS IS THE ONLY SUCH REPORT RECEIVED OF ITS KIND AND CONSIDERED TO BE AN UNUSUAL AND ISOLATED OCCURRENCE WITH NO FURTHER ACTION REQUIRED AT THIS TIME.
THE PACKAGING OF THIS DEVICE WAS DEFECTIVE, AFFECTING THE STERILITY OF THE PRODUCT. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
THE REPORT REPRESENTS A LAWSUIT FILED BY A SINGLE LAW FIRM AGAINST A MEDICAL PRACTICE, THE HOSP AND CO. THE PLAINTIFF'S ATTORNEY HAS ALLEGED PERMANENT PHYSICIAL IMPAIRMENT (DEFINED IN 21 CFR PART 803.3 AS A SERIOUS INJURY) AND DISABILITY, AND PAIN, SUFFERING AND MENTAL ANGUISH IN A PT WHO WAS IMPLANTED WITH THE DEVICE DURING ANTERIOR CERVICAL DISECTOMY. USE OF THIS DEVICE IN ANTERIOR CERVICAL DISECTOMY PROCEDURE IS NOT RECOMMENDED BY THE MFR. THE CO HAS DENIED THE ALLEGATIONS AND DOES NOT BELIEVE THAT THE COMPLAINT REPRESENTS A REPORTABLE EVENT, HOWEVER, TO ER ON THE SIDE OF CAUTION, THIS REPORT IS BEING MADE.
H6 -PART NOT RETURNED, LOT NUMBER NOT AVAILABLE. H1 -ALLEGED INJURY IN CONTEXT OF A LAWSUIT. THIS REPORT AND THE INFO CONTAINED HEREIN IS SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION UNDER 21 CFR, PART 803 AND REPRESENTS THE INFO AVAILABLE TO THE CO AT THE TIME OF THE REPORT. THE REPORT DOES NOT CONSTITUTE AN ACKNOWLEDGMENT THAT THE EVENT REPORTED THEREIN OCCURRED, THAT THE INFO IS ACCURATE IN ANY RESPECT, OR THAT THE CO WAS NEGLIGENT OR RESPONSIBLE FOR ANY WRONGDOING AND IT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE IS DEFECTIVE, OR THAT THE DEVICE MALFUNCTIONED OR OTHERWISE FAILED TO PERFORM IN ANY MANNER, OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN INJURY OR DEATH. H7 -CO REACHED A VOLUNTARY AGREEMENT WITH THE AGENCY TO UNDERTAKE A PT FOLLOW-UP PROGRAM. BY LETTER OF 10/4/96, THE AGENCY DEEMED THE PROGRAM TO BE SATISFACTORILY COMPLETE.
INVESTIGATION CONDUCTED. DR CITES THAT INFECTION CAUSED BY POOR ORAL HYGIENE IS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
A PT WHO HAD A POSITIVE HOME PREGNANCY TEST PRESENTED TO HER DR ON 9/3/96. A URINE SAMPLE WAS COLLECTED AND TESTED TWICE ON THE IMMUNOCONCENTRATION ASSAY LOT NUMBER 591597. THE RESULTS OF BOTH TESTS WERE NEGATIVE. CO DETERMINED THAT THE KIT HAD EXPIRED ON 8/13/96. THE EXPIRATION DATE WAS CLEARLY NOTED ON THE PRODUCT. A SERUM SAMPLE COLLECTED THE SAME DAY WAS TESTED USING AN UNKNOWN QUANTITATIVE METHOD WITH AN HCG RESULT OF 11,700 MLU/ML INDICATING THAT THE PT WAS PREGNANT. THE RESULTS OF THE QUANTITATIVE TESTING WAS AVAILABLE ON 9/4/96. NO PROCEDURES WERE PERFORMED ON THE PT DURING THE DISCREPANCY PERIOD. FURTHER TESTING OF THE KIT WAS NOT PERFORMED AT CO AS THE KIT HAD EXPIRED. NO SAMPLE WAS RETURNED FROM THE CUSTOMER.
THE SUBMISSION OF THIS MEDICAL DEVICE REPORT IS REQUIRED OF DEVICE MFRS BY 21 CFR PART 803. NEITHER THE SUBMISSION OF INFO BY CO PURSUANT TO THIS RULE, NOR THE PUBLIC RELEASE OF SUCH INFO, CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CONNECTION BETWEEN THE PRODUCT AND ANY DEATH OR INJURY. NOTE THAT THERE WAS NO METHOD OR RESULTS CODES NOTED AS THE DEVICE HAD EXPIRED AND NO EVALUATION WAS PERFORMED.
THE SHEATH OF THIS DEVICE WAS DEFECTIVE. THE SHEATH "COLLAPSED" DURING INSERTION. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
INVESTIGATION CONDUCTED. DR IS UNSURE OF CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
EVAL SUMMARY: FINAL ANALYSIS REVEALED DRIVER ARM BINDS DUE TO RUST AND CORROSION. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. SERIAL NUMBER PRE-DATES DRIVENUT MATERIAL CHANGE.
THE TWO YR OLD PT WAS IN OR 4. THE OTHER CO'S REP WAS CALLED TO OR 4, DUE TO THE STAFF HAVING PROBLEMS WITH THE MONITOR. THE REP NOTICED THAT THE CO2, PULSE OX, AND INVASIVE BP WERE SHOWING QUESTION MARKS. THE NIBP WAS CYCLING TRYING TO OBTAIN A PRESSURE. TO THE OTHER REP THE PT APPEARED TO BE IN EXTREME MEDICAL DURESS, POSSIBLE VENTRICULAR FIBRILLATION. THIS CO REP INDICATED THAT THE PT HAD JUST PREVIOUS TO THE INCIDENT BEEN GIVEN A DOSE OF ATROPINE. THE DR THEN MADE REMARKS TO THE REP AND STAFF THAT SHE WAS UNABLE TO OBTAIN READINGS FROM THE MONITOR. THAT, "THE MONITOR WENT OUT." THE PT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER FACILITY IN A COMA.
NEITHER OTHER CO OR THIS CO HAS BEEN ALLOWED TO TEST THE MONITOR IN QUESTION. THE ROOM HAS BEEN SHUT DOWN UNTIL AN INDEPENDENT FIRM CAN EXAMINE THE MONITOR. DURING MY CONVERSATION WITH THE OTHER CO'S REP, CO WAS INFORMED THAT THE MONITOR WAS IN ADULT MODE AT THE TIME OF THE INCIDENT. AT THIS TIME, FROM INTERVIEWS WITH OTHER CO'S AND THIS CO'S PEOPLE INVOLVED, THE DR IS NOT CLAIMING THE MONITOR CAUSED THE MEDICAL CONDITION OF THE PT DIRECTLY, BUT THAT IT DID NOT GIVE ADEQUATE INFO AT A CRITICAL TIME.
DURING A ROUTINE DENTAL PANORAMIC X-RAY EXPOSURE, THE PT MOVED IN SUCH A MANNER AS TO OBSTRUCT THE ROTATION OF THE X-RAY TUBE HEAD. BY PREVENTING THE FREE ROTATION OF THE UNIT THE PT CAUSED RADIATION EXPOSURE IN ONE AREA FOR A LONGER THAN EXPECTED DURATION. AFTER A COUPLE OF SECONDS THE OPERATOL SAW WHAT HAD HAPPENED AND DISCONTINUED THE PROCEDURE.
81 THE DEVICE DID NOT FAIL. OPERATOR ERROR WAS DETERMINED TO BE THE CAUSE FOR THIS REPORT. 10 SVC TECH CONFIRMED THE UNIT WORKED ACCORDING TO SPEC. 200 OPERATOR DID NOT FOLLOW OPERATING INSTRUCTIONS TO CONTINUOUSLY MONITOR THE PT'S POSITION.
INVESTIGATION CONDUCTED. DR DOES NOT CITE CAUSE FOR FAILURE. PT SUFFERS FROM PSYCHIATRIC OR PSYCHOLOGICAL DISORDERS. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
A PT EXPERIENCED A THROMBOEMBOLIC EVENT.
CODE 68 -DEVICE HISTORY RECORDS REVIEW CONDUCTED. CPHV #C139859-D SATISFIED ALL MATERIAL, DIMENSIONAL AND PERFORMANCE REQUIREMENT FOR A SIZE 29 MITRAL AT THE TIME OF MFR AND RELEASE. DOPPLER FINDINGS: "THE PROSTHETIC MITRAL VALVE APPEARED TO FUNCTION NORMALLY WITH ONLY MILD (PHYSIOLOGIC) INSUFFICIENCY,  THERE WAS MILD TRICUSPID REGURGITATION. AORTIC VALVE VELOCITES WERE NORMAL." HEMODYNAMICALOR NORMAL CO'S MITRAL VALVE PROSTHESIS WITH MULTIPLE SMALL MOBILE THROMBI ATTACHED. LEFT ATRIAL ENLARGEMENT WITH SPONTANEOUS ECHO CONTRAST, NORMAL LEFT VENTRICULAR FUNCTION.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
THE INFUSION PUMP WAS PROGRAMMED TO INFUSE AT 25 ML/HR AND 50 ML WAS DELIVERED. NO ADD'L SPECIFIC INFO WAS RECEIVED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. EVALUATION SUMARY: FLOW ACCURACY TESTING PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPEC.
X-TUBE ASSEMBLY 16' X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. DR CITES INFECTION AND SURGICAL TRAUMA AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE SHEATH OF THIS DEVICE WAS DEFECTIVE. THE SHEATH "COLLAPSED" UPON INSERTION. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
EVAL SUMMARY: FINAL ANALYSIS REVEALED DRIVENUT BINDS DUE TO RUST AND CORROSION. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. SERIAL NUMBER PRE-DATES DRIVENUT MATERIAL CHANGE.
A PT WAS TREATED ON 9/4/96 INTO VERTICAL LINES ABOVE THE UPPER LIP. ON 9/5/96, THE PT NOTED A "NODULE" AT THE INNER MUCOSA OF HER UPPER LIP. ON 10/14/96, SHE PRESENTED WITH SLIGHT ERYTHEMA AND INDURATION AT ONE OF THE UPPER LIP TREATMENT SITES, AS WELL AS INDURATION AND SLIGHT TENDERNESS AT THE INNER MUCOSA OF THE UPPER LIP. THE PHYSICIAN DID NOT BELIEVE THAT THE SYMPTOMS REPRESENTED A HYPERSENSITIVITY. HE WAS UNSURE OF A DIAGNOSIS; INTRALESIONAL TRIAMCINOLONE WAS PRESCRIBED.
ON 12/2/96, CLINICAL REPORT FORMS WERE RECEIVED FROM THE PHYSICIAN. ON PHYSICAL EXAM, THERE WAS "INDURATION ON UPPER LIP, PALPABLE BOTH EXTERNALLY AND ON MUCOUS MEMBRANE." THE INTRALESIONAL TRIAMCINOLONE.
DURING THE PROCEDURE THE VALVE OF THIS DEVICE LEAKED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
ACCOUNT REPORTS ONE INCIDENT IN WHICH THE WHITE LEVER BROKE OFF REPORTED DEVICE DURING TURNING. THE RPTR STATED THE LEVER WAS DIFFICULT TO TURN. DUE TO THE BREAKAGE, BLOOD LOSS OCCURRED DUE TO BACK-UP OF BLOOD, AND BLOOD "SPLATTERED ALL OVER NURSE." RPTR UNABLE TO PROVIDE HCP INVOLVED IN INCIDENT. NO PT COMPROMISE REPORTED.
SECTION F COMPLETED BY CO. NO OTHER INFO IS AVAILABLE.
INVESTIGATION CONDUCTED. DR IS UNSURE OF CAUSE FOR FAILURE. PT SUFFERS FROM GRANULOCYTOPENIA. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
EVAL SUMMARY: FINAL REVEALED DRIVENUT SLIDES FREELY DUE TO RUST AND CORROSION. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. SERIAL NUMBER PRE-DATES DRIVENUT MATERIAL CHANGE.
A NEEDLE BROKE-OFF IN RPTR'S AUNITSTATSURGGCJSCHEDULED TO HAVE THE NEEDLE SURGICALLY REMOVED THE FOLLOWING WEEK.
THE BROKEN PORTION OF THE SYRINGE WAS RETURNED AND EXAMINED UNDER MAGNIFICATION. DAMAGE INDICATIVE OF BENDING AND RE-STRAIGHTENING WAS BELIEVED TO BE THE MAIN CAUSE OF THIS NEEDLE BREAKING-OFF.
THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. IT WAS REPORTED BY THE REP. THAT THE SAFETY LOCKOUT OF THE INSTRUMENT DID NOT ACTIVATE. FROM THE THIRD FIRING, THE INSTRUMENT NEITHER STAPLED NOR CUT THE TISSUE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D5,6,10,H4-INFORMATION NOT PROVIDED. CONCLUSION: BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. WE STRIVE TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
INVESTIGATION CONDUCTED. DR DOES NOT CITE A CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
X-TUBE ASSEMBLY 18"X18". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC., OR THE FDA THAT THE DEVICE, QUIKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING THE PROCEDURE, THE GASKET OF THIS DEVICE DISLODGED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
A PT EXPERIENCED A THROMBOEMBOLIC EVENT LEADING TO REOPERATION AND EXPLANT.
SECTION F10. EVENT PROBLEM CODES BASED ON MFR'S UNDERSTANDING OF EVENT. SECTION H6. METHOD CODE 86: OTHER - DEVICE HISTORY REVIEW AND MICROSCOPY PERFORMED. RESULT CODE 300: OTHER - MFG RECORDS REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS AT THE TIME OF MFR AND RELEASE. CONCLUSION CODE 68: OTHER - PATIENT RELATED FACTORS CONTRIBUTED TO EVENT.
PLEASE NOTE THAT ALL INFO IN SECTIONS A,B,D,E, AND F WERE NOT PROVIDED INITIALLY BY THE USER FACILITY AND MFR IS PROVIDING THIS INFO BASED ON CASE INVESTIGATION. ANY INFO NOT PROVIDED IS UNKNOWN OR UNAVAILABLE TO THE USER FACILITY. WHERE DATES ARE SHOWN AS "OO/OO/0000", THE DATE IS UNKNOWN (UNK), EXCEPT IN SECTIONS B2,D5,D7,D11 AND D13 WHERE THE DATE IS NOT APPLICABLE (NA).
THE CUFF WAS REMOVED FROM THE PT AND TUBING PLUGGED DUE TO EROSION - URETHRA.
DURING THE PROCEDURE THE PHYSICIAN WAS UNABLE TO TORQUE THE CATHETER. UPON REMOVAL OF THE SHEATH IT WAS NOTED THAT THE SHEATH WAS KINKED. THE PT IS REPORTED AS FINE. THE DEVICE IS NOT BEING RETURNED FOR CO'S ANALYSIS.
THE INSTRUMENT WAS USED DURING A GASTRIC BYPASS. THE STAPLES DID NOT FORM ON PROXIMAL PART OF STAPLER ON SECOND FIRING. THE FIRST AND THIRD FIRINGS WERE PERFECT. REP RETURNING 2 RELOADS (XR60G) WITH INSTRUMENT. THE CARTRIDGE WHICH MISFIRED IS THE ONE NOT IN THE STAPLER. THERE WAS NO CONSEQUENCE TO THE PT. NO BUTTRESSING MATERIAL WAS USED.
THE DEVICE HAS A SPONTANEOUS RATE CHANGE FROM 80 TO 82. THERE WAS NO PT INJURY. THE HOSP'S BIOMEDICAL ENGINEER TESTED THE DEVICE AND COULD NOT DUPLICATE MALFUNCTION.
THIS EVENT HAS OCCURRED OR IS OCCURRING MORE FREQUENTLY THAN IS STATED IN ITS LABELING OR, IF NO PERTINENT STATEMENT IS CONTAINED IN THE LABELING, THAN IS USUAL FOR THIS DEVICE. N. THIS EVENT HAS OCCURRED IR IS OCCURRING WITH GREATER SEVERITY THAN IS STATED IN ITS LABELING OR, IF NO PERTINENT STATEMENT IS CONTAINED IN THE LABELING THAN IS USUAL FOR THIS DEVICE.
EVAL SUMMARY: FINAL ANALYSIS REVEALED DRIVENUT SLIDES FREELY DUE TO RUST AND CORROSION. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. SERIAL NUMBER PRE-DATES DRIVENUT MATERIAL CHANGE.
INVESTIGATION CONDUCTED. DR DOES NOT KNOW CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
UPON ATTEMPTING INSERTION OF THIS DEVICE IN TO THE PT IT WAS NOTED THAT THE TEFLON COATING ON THE DEVICE HAD PEELED BACK. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTRECTOMY. IT WAS REPORTED THE EZ35W WOULD NOT FIRE AFTER THE SECOND FIRING. IT APPEARED THE INSTRUMENT LOCKED OUT. THERE WAS NO CONSEQUENCE TO THE PT.
9/13/96 0910 MESSAGE AND 800 NUMBER LEFT FOR M.D. TO CALL BACK. 9/16/96 NNCL SENT. 9/16/96 1636 SPOKE TO DR'S PRIVATE SCRUB, WHO WAS ASKED TO FOLLOW UP IN DR'S PLACE. CONFIRMED THE INFORMATION AS REPORTED BY THE REP. SHE STATED ON THE FIRST FIRING OUT OF THE PACKAGE THE INSTRUMENT FIRED BUT WAS DIFFICULT TO OPEN. DR. MANUALLY RETURNED THE HANDLES AND THE JAWS OPENED SLOWLY. THE INSTRUMENT WAS RELOADED AND THEN WOULD NOT CLOSE DOWN ON THE TISSUE. IT WAS TESTED OUTSIDE THE BODY AND WITHOUT TISSUE IN THE JAWS, IT WOULD CLOSE WITHOUT DIFFICULTY. THE INSTRUMENT WAS REMOVED FROM THE FIELD AND ANOTHER WAS OPENED TO COMPLETE THE CASE. TISSUE WAS REPORTED AS NORMAL TISSUE, NOT EDEMATOUS OR UNUSUALLY THICK. A1,2,3,4,B6,7,D10-INFORMATION NOT PROVIDED BY USER FACILITY. H4-INFORMATION NOT AVAILABLE. BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT FIRE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
INVESTIGATION CONDUCTED. DR DOES NOT KNOW A CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT ISCONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE PT WAS BEING SEEN FOR COMPLAINTS OF CHEST PAINS AND SHORTNESS OF BREATH. UPON INQUIRE, THE FOLLOWING MESSAGE WAS RECEIVED. "PROGRAMMED HA DETECTED PARAMETER THAT IS NOT WITHIN PRORAMMABLE RANGE OF THE CURRENT MODULE. BACKUP RESET IS REQUIRED." A BACKUP RESET WAS PERFORMED AND AN INQUIRE REVEALED ALL PARAMETERS ARE OK.
REFERENCE F.10 OF THIS FORM FOR EVENT PROBLEMS CODES.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT OF THE IMPLANT FROM THE TEMPORARY PROSTHESIS AS THE CAUSE FOR FAILURE. THIS FILE IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING INSTALLATION, THE CONSOLE FAILED SELF TEST. ALSO, THERE WAS AN INTERMITTENT "FOOT PUMP HANDLE DISLODGED" ALARM. A FIELD SERVICE ENGINEER ADJUSTED THE CONSOLE AND REPLACED A MICROSWITCH.
MICROSWITCH REPLACED AND CONSOLE ADJUSTED.
INVESTIGATION CONDUCTED. DR DOES NOT HAVE AN EXPLANATION FOR THE CAUSE OF THE FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
A REPORT OF A CASTER BREAKING ON A PT LIFT WHILE A PT WAS BEING TRANSFERRED. THE DEVICE INVOLVED WAS OVER 11 YEARS OLD. NO INJURY WAS REPORTED.
X-TUBE ASSM 16" X 16". DEALER CALIMS X-TUBE BROKE AT CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC., OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
72 HOURS INTO ECLA CASE, TWO OXYGENATORS USED IN PARALLEL, WERE CHANGED OUT DUE TO PLASMA BREAKTHROUGH AND CLOT FORMATION. BOTH UNITS WERE CHANGED OUT AND NO PT INJURY WAS OBSERVED. ECLA IS AN OFF-LABELED USE OF THE DEVICE. THE DEVICE IS LABELED AND DESIGNATED TO OPERATE FOR MAXIMUM PERIOR OF 6 HOURS.
THE PHYSICIAN DISMANTLED BOTH UNITS AND OBSERVED BLOOD CLOTS AT THE VENOUS INLET AND ARTERIAL OUTLET PORTS. BOTH UNITS WERE THEN DISCARDED BY DR. THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIV, ITS OFFICERS, EMPLOYEES, OR AGENTS.
THE BALLOON WAS DEFECTIVE. NO OTHER DETAILS WERE PROVIDED.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF NO", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? N. IS THE EVENT SEVERITY ADDRESSES IN PRODUCT LABELING? N. IF NO", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? N. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES OT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
REPORT RECEIVED OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
REPORT REC'D OF LOSS OF SENSING/CAPTURE.
A CAPD PT REPORTED SEPARATION OF THE TUBING FROM THE CONNECTOR OF THE PERITONEAL DIALYSIS SOLUTION ADMINISTRATION SET. THE PT CLAMPED THE CATHETER TO PREVENT FURTHER LEAKAGE AND REPLACED THE CONNECTOR. THE PT WAS TREATED PROPHYLACTICALLY WITH ANTIBIOTICS.
THE MFR CONFIRMED THAT THE SEPARATION OF THE TUBING FROM THE CONNECTOR WAS DUE TO INSUFFICIENT BONDING MATERIAL AND WILL FOLLOW UP WITH THE PROVIDER OF THE SUB-ASSEMBLY.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUANTITY & QUALITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER HANDPIECE WAS USED.
WHILE TEMPORARILY PROGRAMMING TO AAI MODE, THE DEVICE REVERTED TO BACKUP MODE. BACKUP RESET PERFORMED AND ALL OK.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES.
X-TUBE ASSEMBLY 16" X 18". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVETN IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PLACED PT ON ECMO BYPASS. 45 MINS INTO BYPASS, DEVICE BECAME UNDONE (NOT YET TIE BANDED) FROM TUBING. DR INDICATED MALFUNCTION DID NOT CONTRIBUTE TO THE DEATH OF THE PT. PT WAS IN EXTREMELY POOR CONDITION AND THEY WERE EMPLOYING EXTREME MEANS TO ATTEMPT TO SAVE THE PT. DEVICE WAS NOT SECURED TO PT AS PER DIRECTIONS.
LOT HISTORY REVIEW NON-CONTRIBUTORY. PRODUCT WAS RELEASED MEETING SPEC. PRODUCT WAS NOT RETURNED.
REPORT REC'D OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
DURING THE "READINES OF OPERATION" CHECK AFTER THE DEVICE WAS DELIVERED BACK TO THE CUSTOMER THE DISPLAY WENT BLANK. NO PT WAS INVOLVED IN THE EVENT.
AN INTERMITTENT LOSS OF ATRIAL SENSING WAS OBSERVED.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR TECHNIQUE/TOOLS: DIRECT TRACTION WITH LOCKING STYLET, INTRAVASCULAR COUNTER TRACTION, LASER NO COMPLICATIONS.
THE LEAD WAS CUT AND CAPPED AND LEFT IN SITU DUE TO A REPORT OF A J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
INVESTIGATION CONDUCTED. DR CITES ONLY THAT IMPLANT WAS LOOSE THEREFORE THERE IS NO KNOWN CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR.
THE DEVICE WAS ABOUT TO BE IMPLANTED, WHEN FCE NOTICED THAT UPON INITIAL INQUIRE THE DEVICE WAS IN THE DDD-R MODE WITH A CELL VOLTAGE AT 0.31 VOLTS. THE DATA LAST PROGRAMMED IS 7/17/96. DEVICE WAS NOT IMPLANTED AND IS TO BE RETURNED. THE EVENT DID NOT INVOLVE A PT.
ANALYSIS SUMMARY: THE UNIT IS OPERATING WITHIN NEW DEVICE SPECS. THE OBSERVED "LOW TELEMETERED BATTERY VOLTAGE" WAS THE RESULT OF MIS-COMMUNICATION BETWEEN THE UNLOADED DEVICE AND THE PROGRAMMER AT SOME WAND POSITIONS.
BALLOON LEAKED AFTER 50 HRS OF USE/BALLOON REPLACED WITH A 30CC WHICH WAS USED FOR SEVERAL DAYS/NO PROBLEM.
H-10-SECTION A ALL UNK INFO REQUESTED B UT NOT REC. H-10-SECTION F PROVIDED BY MFR, H-11-SECTION F10 CODE 1052 LABELED.
PARTICULATE CAME FROM THIS PHACOEMULSIFICATION HANDPIECE DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
INTERMITTENT LOSS OF VENTRICULAR CAPTURE WAS OBSERVED. REP WAS NOTIFIED, AND HE INDICATED THAT THE DR HAD ORDERED A 24 HR HOLTOR MONITOR FOR THE PT. THE REP HAD NO OTHER INFO REGARDING THIS EVENT.
UNABLE TO PERFORM ANALYSIS LEAD DAMAGED. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE INNER CATHODE COIL WIRE ON THE DISTAL SECTION OF LEAD WAS PULLED AND STRETCHED OUT OF LEAD BODY DISTAL OF ANODE BAND AND THEN CUT OR SNIPPED, WITH EVIDENCE OF FLARED COIL WIRE ENDS. THE ELECTRODE TIP AND J STIFFENER WIRE WERE NOT RECEIVED. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS NO PORTION OF THE J STIFFENER WIRE WAS RECEIVED.
THE PT CAME TO DR'S OFFICE. THE PT'S ECG SHOWED SINUS RHYTHM AT 60 TO 70 BPM. AN INQUIRE INDICATED THAT THE DEVICE WAS IN BACKUP. PRESSING THE SFI BUTTON TO INITIATE A BACKUP RESET WAS UNSUCCESSFUL MULTIPLE TIMES. THE DEVICE WILL BE EXPLANTED.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL (PRE-EXPOSURE) OF IMPLANT AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY ANS SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE THUMB LEVER ON THE MOUTH GAG WAS FOUND TO BE BROKEN WHEN THE PHYSICIAN ATTEMPTED TO INSERT IT.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. CO IS CURRENTLY UNDERTAKING A FAILURE ANALYSIS INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE PROBLEM.
A TOTAL LOSS OF ATRIAL SENSING WAS OBSERVED. IN ADDITION IT WAS NOTED THAT THE ATRIAL OUTPUT WAS CAPTURING THE VENTRICLE. THE REP WAS CONTACTED VIA FAX. NO FURTHER INFO COULD BE OBTAINED.
THE DEVICE WAS RETURNED WITH NO REASON GIVEN.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE OBSERVED "NO COMMUNICATION" WAS THE RESULT OF A FRACTURED COIL, L-1 AT THE POINT WHERE IT EXITS THE COIL RETAINER ON THE "SIN" SIDE. NO REASON WAS GIVEN FOR THE RETURN AND THE CAUSE OF THE FRACTURE WAS NOT ASCERTAINED.
A LOSS OF ATRIAL CAPTURE WAS OBSERVED. THE REP WAS CONTACTED VIA FAX, NO FURTHER INFO COULD BE OBTAINED.
COMPLETE LOSS OF VENTRICULAR CAPTURE WAS OBSERVED. THE REP WAS NOTIFIED REGARDING THIS EVENT, HE HAD NO FURTHER INFO.
SECTION A THROUGH F WERE COMPLETED BY THE MFR. CO IS CURRENTLY UNDERTAKING A FAILURE ANALYSIS INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE PROBLEM.
REPORT RECEIVED OF J WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
A LOSS OF ATRIAL CAPTURE AND A LOSS OF VENTRICULAR CAPTURE ON THE LAST CYCLE OF THE THRESHOLD MARGIN TEST WERE OBSERVED. THE REP WAS NOTIFIED OF THIS EVENT; HE HAD NO FURTHER INFO.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. CO IS CURRENTLY UNDERTAKING A FAILURE ANALYSIS INVESTIGATION TO DETERMINE THE  ROOT CAUSE OF THE PROBLEM.
BLOOD WAS FOUND IN THE TUBING AFTER OVER NIGHT WAVE FORM DETERIATION. BALLOON WAS REMOVED AND REPLACED WITH ANOTHER BALLOON. IT WAS ALSO REPORTED THAT THE BALLOON WOULD NOT FILL.
H-10-SECTION A ALL UNK REQUESTED BUT NO T REC. H-10-SECTION F PROVIDED BY MFR, H-10-SECTION F10 CODE 1052 LABELED.
DURING AN ANGIOPLASTY PROCEDURE, AN AIR BUBBLE WAS OBSERVED IN THE ARTERY ON THE ANGIOGRAM. THE PT EXPERIENCED NO ADVERSE CONSEQUENCES AS A RESULT OF THE INCIDENT. THE DEVICE WAS DISCARDED BY THE USER. THEREFORE, THE LOT NUMBER COULD NOT BE DETERMINED.
DURING X-RAY AND CT SCANS OF PT'S CHEST, CUSTOM DEVICE STRUTS WERE NOTED TO HAVE BROKEN. THE DEVICES HAD BEEN IMPLANTED IN 1994 TO MAINTAIN APPROPRIATE CHEST CONTOUR. NO PT INJURY REPORTED AS THE RESULT OF BREAKAGE NOTED.
DEVICE NOT REPORTED TO HAVE BEEN EXPLANTED FOLLOWING RADIOGRAPHIC/CT FINDINGS. ADD'L INFO REQUESTED FROM USER FACILITY BUT NOT RECEIVED TO DATE. NOTE: THE INFO IN SECTION F IS BEING SUPPLIED BY THE MFR, NOT THE USER FACILITY. NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY. AT THIS TIME, IT IS NOT KNOWN AS TO WHETHER ADD'L INFO WILL BE RECEIVED CONCERNING THIS EVENT.
THE IMPLANT APPEARS ON X-RAYS TO BE DEFORMED. PT IS HAVING SOME PAIN WHICH MAY OR MAY NOT BE RELATED TO THE IMPLANT. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUCNTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATE. D.6 EXACT SIZE AND LOT NUMBER OF THE COMPONENT IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECOMY. IT WAS REPORTED THE CLIPS DID NOT FORM PROPERLY. THE CLIPS WOULD NOT HOLD ONTO TISSUE. A SECOND WAS INTRODUCED AND THE SAME EVENTS OCCURRED. A THIRD WAS INTRODUCED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
CO# 964586. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS OF BOTH INSTRUMENTS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENTS NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
AFTER PT WAS TAKEN OFF THE BALLOON, THE PERFUSIONIST NOTICED BLOOD IN THE CATHETER TUBING. THE PT HAD BEEN ON THE PUMP FOR 4 HRS. NO PT INJURY OR MEDICAL INTERVENTION OCCURRED. PT HAD ALREADY BEEN RELEASED FROM THE HOSP BEFORE THE INCIDENT WAS REPORTED.
H-10-SECTION A ALL UNK INFO REQUESTED BUT NOT REC. H-10-SECTION F PROVIDED BY MFR, H-11-SECTION F10 CODE 1052 LABELED.
THE CUSTOMER REPORTED THAT THE SYSTEM LEAKED AND THE FLOW CONTROL KNOB WAS BROKEN, AND RETURNED THE UNIT FOR REPAIR. THE REPORTED PROBLEMS WERE CONFIRMED. DURING FUNCTIONAL TESTING, ENOUGH LIQUID OXYGEN LEAKED FROM THE BROKEN FLOW INDICATOR TO POTENTIALLY CAUSE A SERIOUS INJURY IF THIS EVENT WERE TO RECUR. CO SERVICE TECHNICIAN ALSO REPORTED THAT THE FLOW SWITCH LEAKED AND THE BOTTLE HAD A LOSS OF VACUUM. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MFG PROCESS PER THE APPROVED DMR. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED WHICH REMOVED THE FLOW INDICATOR FROM CO UNITS MFG AFTER APRIL 5, 1995.
END USER ALLEGES HE WAS BURNED BY COFFEE WHEN CROSS BRACE BROKE CAUSING CHAIR TO COLLAPSE. CROSS TUBE BROKE AT CTR PIVOT HOLE LOCATION.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 DFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTACT SVC FIRMS OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS SCISSORED WHEN FIRED. IT IS UNK IF THE CLIP SEVERED ANY VESSELS. ANOTHER APLIER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B3,6,7,D10-INFORMATION NOT PROVIDED BY USER FACILITYH4-INFORMATION NOT AVAILABLEH6: CODE 400(OTHER): YIELDED JAWS
THIS PAIR OF SCISSORS BROKE AT THE SCREW HOLE DURING A BLEPHAROPLASTY PROCEDURE. ANOTHER PAIR OF SCISSORS WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. THIS PAIR OF SCISSORS IS VERY OLD AND HAS BEEN REPAIRED NUMEROUS TIMES. THE ETCHING OF THE CATALOG NUMBER IS WORN OFF.
THE CUSTOMER RETURNED THE SYSTEM FOR REPAIR DUE TO AN INACCURATE PULSE MODE. DURING EVALUATION, ENOUGH LIQUID OXYGEN LEAKED THROUGH THE CRACKED CONNECTING TUBES DURING AND AFTER FILL TO POTENTIALLY CAUSE A SERIOUS INJURY SHOULD THIS MALFUNCTION RECUR. CO'S SERVICE TECH ALSO REPORTED THE PNEUMATIC DEMAND DEVICE (PDD) SENSITIVITY WAS OUT OF ADJUSTMENT (WHICH DUPLICATED THE REPORTED PROBLEM), THE QUICK CONNECT LEAKED, THE NUTS ON THE RELIEF ECONOMIZER VALVE WERE LOOSE, AND THE VENT VALVE WAS CRACKED. THE UNIT WAS PARTIALLY REPAIRED AND RETURNED TO THE CUSTOMER. THE CONNECTING TUBES WERE REPLACED, THE PDD WAS ADJUSTED, AND THE RELIEF ECONOMIZER VALVE NUT WAS TIGHTENED. PER THE CUSTOMER'S REQUEST, THE QUICK CONNECT LEAK AND CRACKED VENT VALVE WERE NOT REPLACED. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MFG PROCESS PER THE APPROVED DMR. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED WHICH REPLACED THE CONNECTING TUBES WITH A MORE DURABLE MATERIAL ON UNITS MFG AFTER 9/13/95.
THROUGH THE OUTER POLYURETHANE INSULATION.
DURING A PROCEDURE TO DISSECT A LIPOMA, A BLADE ON THIS PAIR OF SCISSORS BROKE. ANOTHER PAIR OF SCISSORS WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. THE BLADE BROKE IN THE MIDDLE. THIS IS UNUSUAL AND THE CAUSE IS UNKNOWN. THE SCISSORS APPEARS TO BE NEW AND IN GOOD CONDITION. THE BLADE WAS CRACKED BEFORE BREAKING.
THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER ALLEGED THAT WHILE THE VENTILATOR WAS UNPLUGGED FROM THE WALL, WITH THE POWER SWITCH STILL IN THE "ON" POSITION, THE LOSS-OF-POWER ALARM FAILED TO ACTIVATE. THE CUSTOMER CALLED CO TECH SUPPORT AND REPORTED THE INCIDENT. THEY WERE ADVISED TO REMOVE AND REPLACE THE POWER SWITCH AND CHECK THE CONNECTIONS ON THE UTILITY HARNESS. CO HAS NOT VISITED THE HOSP NOR HAS THE UNIT BEEN EVALUATED BY CO REP. REPEATED PHONE MESSAGES SENT TO THE CUSTOMER WERE UNRETURNED. THE STATUS OF THE UNIT IS UNKNOWN. IT IS NOT VERIFIED THAT THE ALARM FAILED TO ACTIVATE, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE. CO WAS NOT AUTHORIZED BY THE CUSTOMER TO AFFECT REPAIRS ON THE VENTILATOR. THE CUSTOMER USES ITS IN-HOUSE BIO-MEDICAL TECHS TO TROUBLESHOOT AND REPAIR THEIR EQUIPMENT.
LEAKAGE WAS NOTICED IN THE DISTAL END OF THE VALVE PRIOR TO IMPLANT. THE VALVE WAS LOST IN THE OPERATING ROOM; ONLY CATHETER WAS RETURNED.
THE PERITONEAL CATHETER WAS RETURNED, BUT THE VALVE WAS NOT; THEREFORE, THE PRODUCT COULD NOT BE EVALUATED FOR LEAKAGE.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CLIP APPLIERS WERE SPITTING CLIPS. THE CLIPS WERE RETRIEVED AND THE CASE COMPLETED WITH A THIRD DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS OF INSTRUMENT B HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. INSTRUMENT A WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THERE WERE PICTURES RETURNED THAT SHOWED THE INSTRUMENTS WITH LOAD IN CLIPS THAT APPEAR TO HAVE JAMMED ON THE SHORT WALL OF THE JAW. NO CONCLUSION COULD BE REACHED AS TO WHY THIS DAMAGE OCCURRED. THE TISSUE BEING FIRED OVER IN THE PHOTOGRAPHS APPEARS TO BE TOO MUCH FOR THIS INSTRUMENT. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
PT WAS BROUGHT IN FOR INTITIAL POSSIBLE APPENDECTOMY. MASS WAS DETERMINED UPON EXPLORATORY OPERATION AND REMOVED. RUPTURED MECKEL'S WAS RESULT (PURSUING PATHOLOGY REPORT) OR ILEO DIVERTICULUM PERFORATION AND ABCESS. A RESECTION OF MASS AND SURROUNDING ILEUM AND COLON WAS PERFORMED. AN ILEO-COLONOSTOMY WAS PERFORMED USING THE STAPLER. POST-OP DIAGNOSIS ON THE FOURTH DAY WITH HEMOGLOBIN AND HEMATOCRIT DROPPING SO DRASTICALLY AND WAS HAVING BLOODING STOOLS. DECISION WAS MADE TO REOP. EXTERNALLY, ANASTOMOSIS WAS INTACT WITH NO BLEEDING. CAPILLARY OOZING WAS CONFIRMED AND SUTURED MANUAL WITH OVERSEWING OF COLOTOMY.
THE DEVICE WAS RETURNED FOR IMPROPER LABELING. IT WAS RECEIVED STILL IN THE STERILE PACKAGE. THE EXACT EVENT DATE IS UNK. THERE WAS NO PT INVOLVED IN THIS EVENT.
REFERENCE SECTION F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. NO PHYSICIAN ANBALYSIS WAS PERFORMED ON THE PACER. THE USE BEFORE DATE ON THE PACKAGE WAS INCORRECT DUE TO AN OPERATOR ERROR DURING THE PACKAGING PROCESS.
REPORT REC'D OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PORTRUSION.
NOTICED BALLOON LEAKING TOOK OUT NO REPLACEMENT NEEDED.
THIS PAIR OF SCISSORS BROKE WHILE THE SURGEON WAS CUTTING TISSUE. ANOTHER PAIR OF SCISSORS WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. THE BLADE WAS BROKEN AT THE SCREW HOLE. THE INSIDE OF THE BLADES ARE DIRTY AND THE SCREW IS RUSTING. THE INSTRUMENT HAD NOT BEEN CLEANED PROPERLY. THE BLADE WAS CRACKED PRIOR TO BREAKING.
REPORT REC'D OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
FROM A REPORT ATTACHED TO THE DEFIBRILLATOR WHEN RETURNED FOR SERVICE, THE FOLLOWING INFO WAS RECEIVED: ARRIVED ON SCENE TO FIND PT NOT BREATHING, NO PULSE. HOOKED UP UNIT. IT CHARGED UP BUT WHEN SHOCK BUTTON WAS PRESSED DURING TONE, THE UNIT WOULD NOT SHOCK. TRIED TO SHOCK TWO TIMES. PARAMEDICS ARRIVED, HOOKED UP THEIR UNIT, PT WAS SHOWING VERY COURSE V-FIB. PARAMEDIC STATED HE THOUGHT THE SAD SHOULD HAVE SHOCKED. PT OUTCOME UNKNOWN. CUSTOMER STATES IN LETTER THAT V-FIB VERIFIED ON TAPE, BUT TAPE IS NOT AVAILABLE BECAUSE MCU WON'T CAPTURE HEADER.
H3 CODE: EVALUATION OF DEVICE IS IN-PROCESS BUT NOT COMPLETE. ADD'L INFO IS BEING SOUGHT FROM CUSTOMER.
H-10-SECTION A ALL UNK INFO REQUESTED NOT RECEIVED. H-10-SECTION F PT CODE PT DEATH NOT RELATED TO CATH. PT EXIRED 6 HRS. LATER DUE TO ILLNESS. NO CATHETER USED AT THE TIME. H-11-DEVICE CODE 1746 LABELED.
X-TUBE ASSEMBLY 20" X 16" DEALER CLAIMS X-TUBE BEOKE AT THE CTR BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
AN OUTER COIL FRACTURE IS SUSPECTED. IN THE BIPOLAR MODE, ASYNCHRONOUS PACING WAS SEEN WITH "HIGH" OHMS ON TELEMETRY. PACING AND SENSING IS APPROPRIATE IN THE UNIPOLAR MODE. THE REP WAS CONTACTED FOR FURTHER INO REGARDING THIS INCIDENT, AT WHICH TIME HE REPORTED THAT THE LEAD HAD BEEN CAPPED, THUS, IT WILL NOT BE RETURNED.
REFERENCE SECTION F.10 OF THIS FORM FOR THE EVENT PROBLEM CODE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THAT THE DEVICE "RELEASED 2 STAPLES AT A TIME." THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B3,6,7,D5,10,H4-INFO NOT PROVIDED. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
FAILURE OF LOW BATTERY ALARM TO PROVIDE AN AUDIBLE SIGNAL BEFORE EQUIPMENT INITIATES AUTOMATIC SWITCH OFF ROUTINE. FAILURE NOTED UNDER LAB CONDITIONS AND NO PT WAS INVOLVED.
DEVICE IS FOR USE FROM A MAIN ELECTRICAL SUPPLY AND IS PROVIDED WITH BATTERY BACK-UP FACILITY, WHERE THE MAINS ELECTRICAL SUPPLY HAS FAILED. AN ALARM CONDITION IS PROVIDED WHEN THIS BACK-UP BATTERY IS RUNNING LOW AND THIS CONDITION IS ACCOMPANIED BY AN AUDIBLE AND VISUAL ALARM TO THE USER. IT WAS NOTED BY A HOSP ENGINEER THAT UNDER CERTAIN OPERATING CONDITIONS THE AUDIBLE ALARM FAILS TO OPERATE ACCORDING TO SPEC. THIS OCCURRENCE WAS ORIGINALLY DETERMINED AS NOT REPORTABLE UNDER MDR REGULATIONS BUT, FOLLOWING DISCUSSIONS WITH REGULATORY PROFESSIONALS OF CO'S USA DISTRIBUTOR MFR HAS SUBSEQUENTLY DECIDED THAT IT WOULD BE PRUDENT TO FILE AS A PRECAUTIONARY MEASURE. FOR THIS REASON THE FILING OF THIS MDR HAD EXCEEDED TO 30 DAY PERIOD.
PT INTUBATED WITH ENDOTRACHEAL TUBE ON 7/17/96. ON 8/1/96 THE BALLOON ON THE ENDOTRACHEAL TUBE LEAKED, NECESSITATING REPLACEMENT.
AFTER RE-INSERTING, IT WOULD NO LONGER FIRE. THE BLACK PLASTIC COLLAR WAS FOUND IN THE PT AND REMOVED DURING THE PROCEDURE. THE REST OF THE COLLAR WAS FOUND OUTSIDE THE BODY. PRODUCT MAY HAVE BEEN DAMAGED AFTER BEING FORCEFULLY REMOVED THROUGH THE TROCAR. (12MM; 11MM INSIDE DIAMETER). THE PROCEDURE WAS LAP HERNIA REPAIR (LEFT SIDE, INDIRECT). THERE WAS NO CONSEQUENCE TO THE PT.
ARTICULATION SLEEVE AND ASSEMBLY WERE BROKEN AND ARTICULATION SLEEVE WAS NOT RETURNED. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE ARTICULATION SLEEVE AND ARTICULATION ASSEMBLY BROKE DURING SURGERY, MAKING THE INSTRUMENT NON FUNCTIONAL. THE ARTICULATION SLEEVE AND ASSEMBLY WERE BROKEN AND THE ARTICULATION SLEEVE WAS NOT RETURNED. THE INSTRUMENT WAS CYCLED AND FIRED, WHILE MANUALLY HOLDING THE ARTICULATION ASSEMBLY TOGETHER. THE INSTRUMENT FIRED THE REMAINING 20 STAPLES. IT WAS CONCLUDED THAT THE DAMAGE TO THE ARTICULATION JOINT MAY HAVE OCCURRED WHEN THE INSTRUMENT WAS REMVOED FROM THE TROCAR DURING SURGERY AS REPORTED BY THE CUSTOMER. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. THE ARTICULATION SLEEVE AND ARTICULATION ASSEMBLY MAY BECOME DAMAGED OR COMPROMISED, IT THE UNIT IT NOT ARTICULATED TO ZERO DEGREES WHEN REMOVED FROM THE TROCAR. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
OR AXLE WITH NUT. DEALER CLAIMS OR AXLE BEARINGS CAME OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REOPRT OF INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
UPON RECEIPT AND EVALUATION OF RETURNED COMPLAINT DEVICE, IT BECAME APPARENT THAT THIS WAS AN ENDOTROL.
WHILE PT WAS PULLING HIMSELF UP THE TRACTION BAR CLAMP ALLEGEDLY SNAPPED. NO INJURY TO THE PT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP THE STAPLES DID NOT DELIVER. THERE WAS NO CONSEQUENCE TO THE PT.
D6; DEVICE RETURNED WITH NO LOT ID. H6; INSTRUMENT WAS REC'D WITH A BROKEN NOSE WELD.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIMS X-TUBE BROKE AT THE WELD.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS RECEIVED BY THE CONTACT PERSON WITH A NOTE STATING THE PRODUCT DID NOT WORK PROPERLY AND THERE WAS NO ADD'L INFO AVAILABLE. THERE WAS NO CONSEQUENCE TO THE PT.
9/9/96 1400 ATTEMPTED TO REACH CONTACT PERSON. NO ANSWER. 9/11/95 1055 CONTACTED SOURCE. SHE STATED THERE IS NO OTHER INFO AVAILABLE. A1,2,3,4,B6,7,D10-INFO NOT PROVIDED BY USER FACILITY. H4,D5-INFO NOT AVAILABLE. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "DID NOT WORK PROPERLY" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE ID. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
FLEY CATHETER BALLOON DEFLATED FOR DISCONTYINUATION; ATTEMPTED TO REMOVE CATHETER. UNABLE TO REMOVE CATHETER FROM PENIS. LIDOCAINE WAS INSTILLED TO RELIEVE PT'S DISCOMFORT AND CATHETER WAS PULLED OUT. UPON REMOVAL A RIDGE WAS NOTED TO BE FORMED ON THE CATHETER.
THE STOP PIN IN THE DOWN ARM BROKE THUS ALLOWING THE WIRES TO TWIST INSIDE THE ARM LEADING TO A SHORT TO GROUND. THIS "SHORT" THEN CAUSES THE TRANSFORMER TO OVERHEAT AND THEN BEGIN TO SMOKE. THE DR THEN CALLED THE FIRE DEPT WHO THEN EXTINGUISHED THE SMOKING TRANSFORMER. UNIT IS 13 YRS OLD. THE SHORT MENTIONED ABOVE IS ON THE OUTPUT OR SECONDARY LOW VOLTAGE SIDE OF TEH TRANSFORMER.
207 THE BROKEN ANTI-ROTATION STOP PIN IN THE DOWN ARM SHOULD HAVE BEEN EVIDENCE THAT MAINTENANCE WAS NEEDED.
NOTE THAT ALL INFO PROVIDED IN SECTION F WAS TAKEN FROM USER FACILITY INITIAL REPORT. EVENT FREQUENCY NOT ADDRESSED IN PRODUCT LABELING. EVENT IS NOT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT. EVENT SEVERITY IS NOT ADDRESSED IN PRODCT LABELING. EVENT IS NOT OF GREATER SEVERITY THAN USUAL FOR PRODUCT. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
X-TUBE ASSEM 10" X 17" DEALER CLAIMS: BROKEN X-TUBE. BROKE AT CTR PIVOT HOLE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC OOPHERECTOMY. IT WAS REPORTED THE DEVICE WAS FIRED TWICE ON THE INFUNDIBULAR PELVIC AND THE OVARIAN LIGAMENTS. THE STAPLE LINE BLED AND APPROXIMATELY EIGHT DEVICE CLIPS WERE USED TO ACHIEVE HEMOSTASIS. REP REPORTS EVU35, TWO CARTIDGES, LOT# GH4324 WERE USED DURING PROCEDURE. THE DEVICE AND CARTRIDGES WERE NOT SAVED. THE ORIGINAL BLUE CARTRIDGE FROM THE DEVICE WAS NOT USED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D10: INFO UNAVAILABLE. D6,H4,6: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO CLOSE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/11/96 -MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
X-TUBE ASSEMBLY 18" X 17". DEALER CLAIMS X-TUBE BROKE AT THE SEAT RAIL.
A NEW ENDOSCOPE EYEPIECE FILTER ASSEMBLY WAS STERILIZED USING THE STERRAD PROCESS. AFTER PROCESSING AND PRIOR TO USE, IT WAS NOTED THAT THE FILTER LENS HAD FALLEN OUT. THERE WAS NO INJURY INVOLVED IN THE INCIDENT. USE OF THE ENDOSCOPE WITHOUT THE FILTER MAY EXPOSE THE CLINICIAN TO A LEVEL OF ENERGY HIGHER THAN CDRH STD 1040.10 MPE .2UJ. IT COULD POSSIBLY REACH A LEVEL OF 4.3 UJ.
ONE BATCH OF EYEPIECES WAS FOUND TO HAE BEEN PRODUCED WITH AN INSUFFICIENT AMOUT OF EPOXY TO RELIABLY HOLD THE LENS IN PLACE. THE CAUSE OF THIS PROBLEM WAS TRACED TO THE WAY THE EPOXING INSTRUCTIONS WERE INTERPETED BY AN ASSEMBLER UNFAMILIAR WITH THE PROCESS. THE PRINTS WERE CLARIFIED AND A FUNCTIONAL TEST ADDED TO THE PROCESS. WE NOTIFIED THE 4 CUSTOMERS WHO WERE DISTRIBUTED SIX EYEPIECES (10 TOTAL) IN THE PRODUCTION BATCH AND REPLACED THE EYEPIECES.
THE DEVICE WAS APPLIED DURING A WEDGE RESECTION PROCEDURE. THE STAPLE LINE LEAKED. THE SURGEON MANUALLY SUTURED THE APPLICATIONS SITE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
12/05/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN E1, F5 AND D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
X-TUBE ASSEMBLY 20" X 16". DEALER CLAIMS X-TUBE BROKE AT THE RIGHT SIDE.
WAITING FOR RETURN OF DEVICE TO PERFORM EVAL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO; DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
UNABLE TO ENGAFGED STAPLER. IT THEN MISFIRED.
10/11/96 -SUBMISSION OF INITIAL REPORT TO FDA BU MFG.
STAFF FOUND IV BAG EMPTY AT 11:30 P.M. CO'S PUMP WAS SET ON 10. VOLUME TO BE INFUSED SHOWED 226CC. HEPARIN WAS INCREASED AT 9:00.
RESULT CODES NOT ASSIGNED BECAUSE PUMP WAS NOT RETURNED FOR EVALUATION. HOSP'S BIOMED TESTED THE PUMP AND NO FAULT WAS FOUND. THE HOSP SUSPECTS POSSIBLE MISLOAD OF THE IV SET. ADD'L INSERVICING HAS BEEN SCHEDULED ON PROPER LOADING OF THE IV SET PER THE DFU. SECTIONS A-E ARE PER THE ATTACHED VOLUNTARY MEDWATCH REPORT RECEIVED FROM THE HOSP WITH CORRECTIONS MADE TO SECTIONS D-1,2 AND 6 TO REFLECT THE CORRECT BRAND NAME, TYPE OF DEVICE, MODEL AND SERIAL NUMBER. SECTIONS D-9 INDICATES PUMP IS AVAILABLE FOR EVALUATION, HOWEVER HOSP IS NOT RETURNING FOR EVALUATION. SECTION F WAS COMPLETED BY THE MFR. FILE# 08-96-110. MFR'S REPORT DATE 9/18/96.
OVERDOSE: A WOMAN REPORTED THAT SHE REC'D AN OVERDOSE OF INSULIN WITH HER FIRST INJECTION OF NOVOLIN N (RDNA) PENFILL INSULIN IN A 1.5 DEVICE. THE WOMAN FELT THAT THE DEVICE OVER DELIVERED THE DOSE OF INSULIN. SHE STATED THAT SHE WENT TO THE ER FOLLOWING THE INJECTION BUT SHE DID NOT REMEMBER EXPERIENCING ANY SYMPTOMS. THE WOMAN DENIED ANY LOSS OF CONSCIOUSNESS BUT REPORTED THAT THE WOMAN PRESENTED TO THE ER WITH THE COMPLAINT THAT SHE THOUGHT SHE ACCIDENTALLY REC'D 80 UNITS OF INSULIN WHEN SHE NORMALLY TAKES HALF THAT AMOUNT. SHE WAS ADMITTED FOR OBSERVATION AND OVER THE 24 HOUR HOURS THAT SHE WAS OBSERVED SHE HAD. NO SIGNIFICANT HYPOGLYCEMIA DEVELOPED. HE CONCLUDED THAT THERE WAS NO UNDUE HARM CAUSED TO THE WOMAN BY THE EVENT. THE WOMAN HAS NOT RETURNED THE DEVICE TO FOR EXAMINATION.
IS THE EVENT LISTED IN INSERT? NO. IS THE EVENT OCCURRING MORE FREQUENTLY? NO. IS THE SEVERITY OCCURRING MORE FREQUENTLY? NO.
THE PT REPORTED THAT HER TRACHEOSTOMY TUBE WOULD NOT LOCK.A IT DID NOT APPEAR TO FIT OR SEAT PROPERLY. ONCE SHE GOT THE INNER CANNULA IN, SHE COULD NOT UNLOCK IT TO REMOVE IT WITHOUT FIRST REMOVING THE TRACHEOSTOMY TUBE ITSELF. SHE REPORTED GAGGING AND CHOKING ON SECRETIONS. THE DEVICE HAD BEEN IN PLACE APPROX. 2 DAYS. ALTHOUGH THE PT WAS ADVISED TO SEEK MEDICAL ASSISTANCE, SHE REPORTED THAT HER PHYSICIAN HAD NOT RESPONDED.
THE REPORTED PROBLEM COULD NOT BE VERIFIED OR DUPLICATED. A FUNCTIONAL FIT OF THE RETURNED DEVICE WAS PERFORMED, AND THE INNER CANNULA AND OUTER CANNULA FIT WAS FOUND TO BE ACCEPTABLE. A TORQUE MEASUREMENT OF THE FORCE REQUIRED TO LOCK AND UNLOCK THE INNER CANNULA WAS FOUND TO BE WITHIN SPECIFICATIONS.
THE DEVICE WAS USED DURING A SUB-TOTAL GASTRECTOMY. IT WAS REPORTED THE "CARTRIDGE DID NOT FIT THE INSTRUMENT AND DROPPED." THE CARTRIDGE FELL INTO THE PT. THERE WAS NO CONSEQUENCE TO THE PT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO REMOVE. THE SURGEON MANUALLY MANIPULATED THE DEVICE FROM THE APPLICATION SITE AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE PRODUCT WAS APLIED DURING THE REMOVAL OF AN EPIDURAL CYST. THE WOUND DEHISCED. THE SURGEON REMOVED THE SUTURE AND APPLIED ANOTHER PRODUCT  RTO CORRECT THE SITUATION.
THE DEVICE WAS USED DURING A RIGHT HEMI-COLECTOMY. IT WAS REPORTED THE SURGEON FIRED THE DEVICE AND FELT THE TACTILE FEEDBACK WAS DIFFERENT FROM THE USUAL ONE. AFTER FIRING, HE CHECKED THE WASHER WHICH WAS BROKEN, HE CAREFULLY OBSERVED THE DOUGHNUT AND FOUND THAT IT WAS PERFECT. HE THEN FOUND THE LEAKAGE FROM THE INTESTINE-ALL STAPLES OF POSTERIOR WALL WERE MISSING. HE CUT THE COLON AND THERE WERE FOURTEEN STAPLES ON THE SPECIMEN OF THE ANTERIOR WALL AND NONE ON THE POSTERIOR WALL. A SECOND DEVICE WAS USED FOR RE-ANASTOMOSIS, THIS WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D10: INFO NOT PROVIDED BY AFFILIATE. BASED ON INFO RECEIVED AND VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED REPORTED INCIDENT. INSTRUMENT, WHEN FIRED IN LAB, FIRED AND FORMED STAPLES AS DESIGNED AROUND ENTIRE STAPLE RING WITH NO DIFFICULTIES NOTED. IT SHOULD BE NOTED, EACH INSTRUMENT IS 100% INSPECTED FOR STAPLE PRESENCE THROUGH AN AUTOMATED VISION SYSTEM PRIOR TO SHIPMENT. THEREFORE, IT COULD NOT BE ASCERTAINED AS TO WHY STAPLES WERE REPORTEDLY MISSING. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF REPORTED INCIDENT.
EVAL SUMMARY: FINAL ANALYSIS REVEALED A LOOSE PUSH PAWL PIN. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY.
THE PRODUCT WAS APPLIED DURING THE RMEOVAL OF AN EPIDURAL CYST. THE WOUND DEHISCEND. THE SURGEON REMOVED THE SUTURE AND APPLIED ANOTHER PRODUCT TO CORRECT THE CONDITION. THE HOSP HAS REPORTED THE PT HAD NO POST-OPERATIVE COMPLICATIONS.
DURING TURP PROCEDURE, A "POPPING" OR "CRACKLING" SOUND WAS HEARD FROM THE RESECTOSCOPE. PT SUSTAINED 2 CM. BURN UNDER DORSAL SIDE OF PENIS AND 1 CM. BURN ON RIGHT LATERAL SIDE OF PENIS.
PROBLEM WAS DUE TO EXCESSIVE LEAKAGE CURRENT VIA THE STOPCOCK HANDLE AND/OR OTHER METAL PARTS OF THE RESECTOSCOPE; CAUSED BY BADLY CHARRED RESECTOSCOPE INSULATION; EXACERBATED BY THE REUSE OF DISPOSABLE CUTTING LOOPS. MAJOR INSTRUMENTS USED ARE 8 TO 16 YRS OLD AND HAVE SEEN MUCH SERVICE; CUSTOMER HAS BEEN ADVISED THAT REPLACECMENT IS OVERDUE.
WHEN CLOSING SKIN AT END OF PROCEDURE, DR LEANED SLIGHTLY AGAINST TOURNIQUET AND IT IMMEDIATELY DEFLATED. TUBING DISCONNECTED FROM BLADDER.
THE DEVICE WAS USED DURING A V.A.T.S. (LUNG) PROCEDURE. IT WAS REPORTED THE DEVICE WOULD NOT FIRE AND THE CARTRIDGE CAME OUT OF THE DEVICE WHEN IT WAS FIRED. THERE WAS NO CONSEQUENCE TO THE PT. 8/14/96 "THE INSTRUMENT WAS INSERTED INTO THE OPENING AS PER NORMAL. THE DEVICE WOULD NOT FIRE, THE DEVICE WAS REMOVED WITH THE CARTRIDGE INTACT. THE CARTRIDGE WAS DISCARDED BY THE CUSTOMER AND INSTRUMENT WAS PUT ASIDE FOR THE REP." A SECOND WAS USED TO COMPLETE THE CASE.
CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT FIRE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE CARTRDIGE RETENTION FEATURE WAS MEASURED AND WAS FOUND TO BE WITHIN DESIGN SPECS. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED.  COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
THE PATCH LEAKED APPROX. 50-100CC AND BECAME BLOOD-TIGHT ON ITS OWN AFTER APPROX. 10-15 MINUTEES. THE PATCH WAS LEFT IN. THE PT'S CONDITION IS OK. NOTE: THE EXACT DATE OF THE INCIDENT IS NOT ATTAINABLE, BUT THE DOCTOR STATES IT HAPPENED ABOUT TWO WEEKS PRIOR TO THE DATE OF THIS REPORT.
SINCE NO PRODUCT IS TO BE RETURNED, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MANUFACTURING BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-ONE SIMILAR COMPLAINT AGAINST THIS BATCH.
ON 9/3/96, THE FACILITY'S MATERIALS COORDINATOR CONTACTED A MFR SALES REPRESENTATIVE AND REPORTED THAT THE DEVICE PACKAGING WOULD NOT TEAR PROPERLY.
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE FOLLOWING IS THE RESULTS OF THE MANUFACTURER'S INVESTIGATION: A REVIEW OF THE POUCH SHOWED THAT THE DEVICE TORE FROM ONE SIDE SEAL TO THE OTHER, INSTEAD OF PEELING DOWN THE SEAL. THE TEARING OF THE DEVICE APPEARS TO BE THE RESULTS OF A SLIGHT OVER-CHEVRON SIDE OF THE POUCH; THIS WOULD CAUSE THE DEVICE TO  SHEAR INSTEAD OF PEELING DOWN THE SEAL. THE SHEARING OF THE DEVICE DOES NOT HAVE ANY DETRIMENTAL EFFECT ON THE PACKAGED COMPONENTS (NO PARTICULATE OR CONTAMINATION IS GENERATED: THE DEVICE SHEARS CLEANLY) AND PRESENTS AN INCONVENIENCE TO THE USER. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG/LOT NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING VARIANCES RELATED TO THIS EVENT. THE CUSTOMER'S COMPLAINT THAT "THE PACKGAGE WOULD NOT TEAR PROPERLY" HAS BEEN CONFIRMED. BASED ON THE INFORMATION AVAILABLE, THIS EVENT IS BELIEVED TO BE AN ISOLATED INCIDENT. THE CUSSTOMER WILL BE NOTIFIED OF THE MANUFACTURER'S FINDINGS. NO FURTHER DETAILS ARE AVAILABLE. THE MANUFACTURER IS NOW CLOSING THE FILE ON THIS EVENT.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL LOADING OF THE IMPLANT & INSUFFICIENT BONE QUALITY AS CAUSES FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RLEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT RELFECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
AFTER IMPLANTING THE GRAFT AND RELEASING THE CLAMPS, THE GRAFT LEAKED APPROX. 60-80CC OF BLOOD THROUGH ITS WALLS WHEN IT WAS TOUCHED BY FINGER AND, OR FORCEPS BY THE DR. GELFOAM AND PROTAMINE WERE USED TO STOP THE BLEEDING AND THE GRAFT WAS LEFT IN. THE PT'S CONDITION IS FINE.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MFR BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-NO SIMILAR COMPLAINTS AGAINST THIS BATCH.
IT WAS REPORTED "DIRECTLY FROM THE HOSP, THAT WHILE TRYING TO USE THE DEVICE CLIPS FELL OUT OF INSTRUMENT. SWITCHED TO ANOTHER INSTRUMENT WHICH WAS FINE. THE NEXT TWO CLIP APPLIERS JAMMED AND THE CLIPS FELL OUT. THEY HAD TO RETRIEVE THE CLIPS FROM ABDOMEN OF PT. COMPLETED PROCEDURE BY SWITCHING TO ANOTHER INSTRUMENT. PT OK. TWO INSTRUMENT DISCARDED AT TIME OF USE. ONLY ONE BEING RETURNED FOR EVAL. NO FURTHER RECORDS KEPT BY HOSP. THERE WAS NO CONSEQUENCE TO PT.
A1,2,3,4,B6,7,D10,E1,2,3-INFO NOT PROVIDED BY AFFILIATE. H4,8-INFO NOT AVAILABLE. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
DURING A ROUTINE PHACOEMULSIFICATION PROCEDURE, THE DOCTOR REPORTED OBSERVING BROWNISH MATERIAL FLOWING INTO THE PT'S EYE. THE DOCTOR THOUGHT THAT THE MATERIAL MAY BE METALLIC. THE EVENT OCCURRED ON THE INITIAL USE OF THE DEVICE. THE PARTICLES WERE REMOVED FROM THE PT'S EYE, HOWEVER THEY WERE NOT SAVED FOR EVAL.
86 EXFOLIATION TESTS PERFORMED.EVAL SUMMARY. EXFOLIATION TESTING WAS PERFORMED ON THE HANDPIECE AND CO'S RESULTS WERE NOT ABLE TO DUPLICATE THE CUSTOMER'S REPORT. THE PRODUCT WAS FOUND TO BE WITHIN THE SPEC FOR THIS DEVICE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE CLIPS DID NOT FORM PROPERLY AND THE INSTRUMENT JAMMED; THE CLIPS WERE SCISSORING SLIGHTLY. A SECOND DEVICE WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A GUIDEWIRE USED FOR FILTER PLACEMENT BECAME LODGED IN THE FILTER STRUTS FOLLOWING DEPLOYMENT OF THE FILTER VIA A JUGULAR APPROACH. THE FILTER WAS  PULLED BACK IN THE SHEATH AND THE FILTER SHEATH WERE REMOVED AS A UNIT. ANOTHER FILTER WAS SUCCESSFULLY PLACED WITH NO PT COMPLICATIONS. THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE GUIDEWIRE WAS RETURNED IN ITS ENTIRETY HOWEVER, IN TWO PIECES. THE WIRE WAS STRETCHED AND THE BALLWELD PORTION OF THE DISTAL TIP WAS LODGED IN BETWEEN TWO LEGS AT THE TIP OF THE FILTER.
THE SHAFT ON THE CLAMP FRACTURED OFF WHILE CLAMPED ON THE PT'S AORTA. THERE WAS NO APPARENT PT COMPLICATONS FROM THE INCIDENT AT THIS TIME.
VISUAL EXAMINATION OF THE PRODUCT SAMPLE REVEALED THAT THE INSTRUMENT WAS BROKEN AT THE MALE PORTION OF THE BOXLOCK. IT WAS NOTED THAT THE LOT CODE WAS MFG IN 1990. SINCE THE MFG OF THE INSTRUMENT, AN ENGINEERING DESIGN CHANGE HAS BEEN IMPLEMENTED TO MINIMIZE THIS TYPE OF ISSUE. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND NO COMPLAINTS HAVE BEEN RECEIVED FOR THIS ISSUE AFTER THE DESIGN CHANGE IMPLEMENTATION.
DEVICE RETURNED FOR ANALYSIS VIA CO REP. PT HAS NOT BEEN UNDER CARE OF THE PHYSICIAN OF RECORD FOR 9 MONTHS. NO OTHER INFO AVAILABLE REGARDING THE PT. DEVICE REC'D FROM PHYSICIAN WHO WAS RETIRING FROM HIS PRACTICE-UNABLE TO FIND INFO RELATIVE TO THE CIRCUMSTANCES OF EXPLANT.
SAMPLES FROM THE SAME LOT WERE EVALUATED FOR PERFORMANCE CHARACTERISTICS. MANUAL 90 DEGREE BEND TEST WAS PERFORMED; NONE OF THE TEST SAMPLES BROKE. OTHER SAMPLES WERE TESTED FOR NEEDLE STRENGTH AND WERE WITHIN THE SPECIFIED RANCE. ALL MANUFACTURING RECORDS WERE IN COMPLIANCE WITH INTERNAL AND SPECIFICATIONS. THERE HAVE BEEN NO SIMILAR REPORTS AGAINST THIS LOT. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFORMATION NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE.
A PT UNDERWENT BREAST SURGERY PERFORMED BY A PLASTIC SURGEON. DURING CLOSURE OF THE FASCIA, A T-5 NEEDLE BROKEN OFF. THE BROKEN NEEDLE TIP WAS EVENTUALLY RETRIEVED FROM THE FASCIAL TISSUE WITHOUT THE USE OF X-RAY. THE PROCEDURE WAS DELAYED ABOUT 20 MINUTES. THERE WAS NO RESULTANT INJURY TO THE PT.
DURING A LOW ANTERIOR RESECTION PROCEDURE, THE INSTRUEMENT WAS DIFFICULT TO OPEN. THE SURGEON MANUALLY MANIPULATED THE DEVICE OPEN. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
11/11/96 - SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.ADDITIONAL DATA ENTERED IN D9 AND E1. CORRECTED DATA ENTERED IN B4 AND G4.
CO WAS CONTACTED BY DIST AND FOLLOWED UP WITH CUSTOMER DIRECTLY. IT WAS REPORTED THE INSTRUMENTS WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE INSTRUMENTS WERE SHOOTING OUT TWO CLIPS AT A TIME. AFTER THE INITIAL INSTRUMENT WAS USED, A SECOND WAS OPENED AND ALSO DOUBLE-FIRED. A FOURTH WAS USED TO COMPLETE THE CASE. THE FIRST THREE INSTRUMENTS HAD THE SAME LOT NUMBER. THE DIFFICULTY OCCURRED RIGHT AWAY. CLIPS WERE RETRIEVED FROM PT. THERE WAS NO CONSEQUENCE TO THE PT.
A FILTER WAS INTENTIONALLY DEPLOYED INTO CLOT AND REMAINS IN A SUPRA RENAL POSITION EMBEDDED IN CLOT. FOLLOW UP REVEALED THAT A PRE-PLACEMENT VENA CAVOGRAM WAS DONE AND THROMBUS WAS NOTED. DUE TO THE PT'S CONDITION, THE PT'S INFERIOR VENA CAVA IS FILLED WITH CLOT AND ANTICOAGULANTS ARE CONTRAINDICATED. NO FURTHER ACTION IS PLANNED ALTHOUGH THE PHYSICIAN DOES NOT FEEL THE PT IS PROTECTED FROM CLOT. THE PT HAS BEEN DISCHARGED AND SENT HOME. THIS DEVICE REMAINS IMPLANTED AND WILL NOT BE AVAILABLE FOR EVALUATION. CO'S FOLLOW UP REVEALED THE PHYSICIAN WAS AWARE THAT CLOT WAS PRESENT BEFORE HE DEPLOYED THE FILTER. NO MALFUNCTION OF THIS DEVICE WAS REPORTED.
F 10. #2200-OTHER/PT NOT PROTECTED, #1236-LABELED, #1526-LABELED, #2203-OTHER/NO MALFUNCTION OF THE DEVICE WAS REPORTED. THE DEVICE WAS INTENTIONALLY RELEASED INTO CLOT.
DURING IMPLANTATION, THE VALVE DID NOT FUNCTION. THE VALVE DID NOT HAVE DRAINAGE.
THE VALVE HAS BEEN RETURNED TO CORDIS BIOT FOR EVALUATION AND TESTING, HOWEVER, THE ENGINEERING EVALUATION IS NOT YET COMPLETE, PLEASE NOTE DATE OF 12/26/96 FOR SUBMISSION OF SUCH INFO PENDING COMPLETION OF THE ANALYSIS.
DURING A LOW ANTERIOR RESECTION PROCEDURE, A COMPONENT DISENGAGED FROM THE DEVICE. THE SURGEON RETRIEVED THE COMPONENT WITHOUT INCIDENT.
10/3/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISISON OF INITIAL REPORT TO FDA BY MFG.
A FILTER DID NOT OPEN COMPLETELY AFTER DEPLOYMENT VIA A FEMORAL APPROACH. A SECOND FILTER WAS PLACED INSIDE THE FIRST FILTER. THE PT IS PROTECTED AND NO FURTHER ACTION WILL BE TAKEN. THIS DEVICE REMAINS IMPLANTED AND WILL NOT BE AVAILABLE FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. FOLLOW UP INDICATED FREQUENT AND/OR CONTINUOUS FLUSHING WAS NOT PERFORMED PRIOR TO DEPLOYMENT AND MAY HAVE CONTRIBUTED TO THIS EVENT.
THE GRAFT "OOZED" BLOOD THROUGH ITS WALLS WHEN THE CLAMP WAS RELEASED. THE DR THEN PACKED THE GRAFT WITH SPONGES AND THE HEPARIN WAS REVERSED WITH PROTAMINE TO STOP THE BLEEDING. THE BLEEDING STOPPED AND THE GRAFT WAS LEFT IN. INTRA-OPERATIVELY, THE PT RECEIVED THREE UNITS OF PACKED RED BLOOD CELLS. THE PT'S CONDITION POST-SURGERY WAS STABLE. NOTE: THE NURSE STATES THAT THE OVERALL BLOOD LOSS DURING THE PROCEDURE WAS APPROX. 1200CC, BUT THE ACTUAL AMOUNT LOST THROUGH THE GRAFT WALLS WAS UNKNOWN AND COULD NOT BE DETERMINED.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MANUFACTURING BATCH RECORDS FOR THE DEVICE WERE REVIEWED. THE BATCH RECORDS WERE NOT ATYPICAL-NO SIMILAR COMPLAINTS AGAINST THIS BATCH.
REPORT REC'D OF PT DEATH UNRELATED TO DEVICE. UPON REMOVAL OF THE DEVICE FROM THE PT THE LEAD WAS FOUND TO BE FRACTURED. ANALYSIS IS PROVIDED.
THIS ENTIRE FORM COMPLETED BY MFR. EVAL SUMMARY. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED 9MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 79MM AND HAS MIGRATED DOWN LEAD BODY 51MM PROXIMAL OF WELD SITE. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE PROXIMAL END OF THE J STIFFENER WIRE WHICH FRACTURED 9MM PROXIMAL OF WELD SITE HAS ABRADED A HOLE INT HE OUTER POLYURETHANE INSULATION 9MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE LENGTH OF THE J STIFFENER WIRE WAS REC'D WITH ALL RECORDED MEASUREMENTS ADDING UP TO 87MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES OUTER POLYURETHANE INSULATION LACERATIONS 9CM, 15CM, 17.5CM AND 21CM DISTAL OF PROXIMAL TERMINAL PIN. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP. THE DEVICE JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B3,6,7,D10,E1,2,3-INFORMATION NOT PROVIDED BY AFFILIATE. D5,H4: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "JAMMED" DURING SURGERY MAY HAVE BEEN DUE TO AN INVERTED STAPLE LOCATED IN THE CARTRIDGE TRACK. THE INSTRUMENT WAS RECEIVED WITH 2 UNFORMED STAPLES JAMMED IN THE CARTRIDGE NOSE, ON TOP OF ONE ANOTHER, AND THE LIFTER WAS STUCK IN THE UP POSITION. THE FIRST STAPLE IN THE TRACK WAS OBSERVED TO BE TWISTED FOLLOWED BY AN INVERTED STAPLE. THE 2 STAPLES JAMMED IN THE NOSE WERE REMOVED, AND THE TWISTED AND INVERTED STAPLES WERE ALSO REMOVED, AND THE INSTRUMENT THEN CYCLED AND FIRED THE REMAINING 22 STAPLES WITHOUT INCIDENT. IT WAS CONCLUDED THAT THE INVERTED STAPLE WAS DUE TO AN ASSEMBLY ERROR AND HAD CAUSED THE STAPLES TO TWIST AND JAM IN THE NOSE. COMMENTS: THE ASSEMBLY MANAGEMENT HAS BEEN NOTIFIED OF THIS INCIDENT AND PRODUCT INQUIRY WILL MONITOR FOR ADDITIONAL OCCURRENCES. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
DURING A HERNIA PROCEDURE. A COMPONENT DISENGAGED FROM THE DEVICE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. IT WAS REPORTED THAT "WHEN FIRING THE DEVICE FOR LIGATION OF SHORT GASTRICS, CLIP WOULD COME SHOOTING OUT OF THE INSTRUMENT WITHOUT STOPPING IN INSTRUMENT JAWS. IT SEEMS LIKE JAW IS TOO PARALLEL TO GET A GRIP OF THE AUTOMATICALLY LOADED CLIP". THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D10-INFO NOT PROVIDED BY USER FACILITY. H4,8,D5-INFO NOT AVAILABLE. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THIS INQUIRY WAS ORIGINALLY REPORTED AS TO RPO "RECORD PURPOSES ONLY." IF THE JAWS ARE CLOSED A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
UPON IMPLANTATION, THE GRAFT LEAKED BLOOD (QUANTITY UNATTAINABLE) THROUGH ITS ENTIRE SURFACE. THE GRAFT BECAME BLOOD-TIGHT ON ITS OWN AFTER APPROX. 5-10 MINUTES. THE GRAFT WAS LEFT IN. THE PT'S CONDITION IS FINE.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKES "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE QUALITY CONTROL TEST RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE TEST RECORDS WERE NOT ATYPICAL - NO SIMILAR COMPLAINTS AGAINST THIS BATCH.
PERFORATION - POST LATERAL BRANCH WITH TOTAL OCCLUSION. NO INTERVENTION REQUIRED, PERFORATION SELF SEALED.
VISUAL EXAMINATION: UPON RECEIPT, THE TIP COILS WERE FOUND TO BE STRETCHED, DISTAL TO THE BLACK PTFE SLEEVE. A SEPARATION IN THE GUIDEWIRE SHAFT WAS NOTED BENEATH THE PTFE SLEEVE, 3.3. CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAMINATION: THE PTFE SLEEVE WAS REMOVED FROM THE GUIDEWIRE SEPARATION AREA REVEALING THE GUIDEWIRE'S FRACTURED AREAS. FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED BOTH FRACTURED ENDS TO EXHIBIT A PRONOUNCED CORROSION DEGRADATION. THE MATERIAL WAS FOUND TO BE SEVERELY PITTED AND THE INTERIOR OF THE WIRE APPEARED SIMILAR TO A HYPO-TUBE. ALTHOUGH THE EXACT CAUSE FOR THE GUIDEWIRE DAMAGE COULD NOT BE DETERMINED, IT IS SUSPECTED THAT, DURING THE ORIGINAL MFG PROCESS, PRIOR TO GRINDING, A VOID EXISTED WITHIN THE MATERIAL. THIS INTERNAL VOID WAS SUBSEQUENTLY ELONGATED BY THE DRAW-DOWN PROCESS. DURING THE GRINDING OPERATION, CAVITIES WERE OPENED UP ON THE OUTER SURFACES OF THE WIRE OPPOSITE TO THE INTERNAL VOID, ALLOWING CORROSIVE AGENTS TO ATTACK THE WIRE EXTERNALLY AND INTERNALLY. THIS RANDOM ANOMALY APPEARS TO BE AN ISOLATED INCIDENT, RELATED TO A VERY RARE MATERIAL DEFECT. IT IS BELIEVED THAT THE FRACTURED AREA BENNEATH THE INTACT PTFE SLEEVE IS TOTALLY UNRELATED TO THE REPORTED VESSEL PERFORATION.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT EJECTED CLIPS PREMATURELY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/3/96-MEDWATCH REORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
THE GRAFT WAS IMPLANTED FOR AN OCCLUSIVE DISEASE AND THEN LEAKED BLOOD (THE EXACT QUANTITY IS REPORTED TO BE NOT ATTAINABLE) FROM THE CROTCH AND "SWEATED" OVER ITS ENTIRE SURFACE. THE SURGEON SUTURED THE GRAFT TO STOP THE LEAKAGE, BUT COULD NOT COMPLETELY CONTROL THE BLEEDING AND THEREFORE EXPLANTED THE ILIACS, REPLACING THEM WITH ANOTHER BRAND GRAFT. DURING THE PROCEDURE, A CELL-SAVER WAS USED. THE PT'S CONDITION IS FINE.
A RETURNED SEGMENT OF THE GRAFT WAS EVALUATED BY CO'S CONSULTING PATHOLOGIST. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL - ONE SIMILAR COMPLAINT AGAINST THIS BATCH. GROSS DESCRIPTION: RECEIVED IN FORMALIN IS A SEGMENT OF CRIMPED DACRON VASCULAR GRAFT WHICH MEASURES 3.2 CM IN LENGTH BY 1.7 CM IN DIAMETER. THE SURFACE IS DULL. NO BLOOD OR TISSUE ELEMENTS ARE PRESENT. REP. SECTIONS ARE EMBEDDED UNDER MD-924 AND MD-925. MICROSCOPIC DESCRIPTION: A HEMASHIELD DACRON VASCULAR GRAFT WITH COLLAGEN COATING IS IDENTIFIED. THE COLLAGEN COATING IS PRESENT ON THE LUMINAL SURFACE, WITHIN THE INTERSTICES, AND ON THE PERIADVENTITIAL (OUTER) SURFACE OF THE DACRON GRAFT. NO LOSS OF INTEGRITY OF THE COLLAGEN COATING IS IDENTIFIED. NO BLOOD OR TISSUE ELEMENTS ARE IDENTIFIED. SUMMARY: A HEMASHIELD DACRON VASCULAR GRAFT WITH COLLAGEN COATING IS IDENTIFIED. NO LOSS OF INTEGRITY OF THE COLLAGEN COATING IS IDENTIFIED.
WHEN THE GRAFT WAS UNCLAMPED, APPROX. 750CC OF BLOOD LEAKED THROUGH HOLES IN ITS MAIN BODY. THE GRAFT STOPPED LEAKING ON ITS OWN AND WAS LEFT IN. THE PT'S CONDITION IS FINE.
THREE UNUSED SEGMENTS OF THE COMPLAINT GRAFT WERE EVALUATED BY OUR CONSULTING PATHOLOGIST. A COPY OF THAT REPORT IS ATTACHED. SINCE THE ACTUAL PORTION OF THE GRAFT INVOLVED IN THE COMPLAINT WAS LEFT IN THE PATIENT AND THEREFORE NOT AVAILABLE FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL - NO SIMILAR COMPLAINTS AGAINST THIS BATCH. GROSS DESCRIPTION: RECEIVED IN FORMALIN IS A SEGMENT OF DACRON VASCULAR GRAFT MEASURING 10 CM IN LENGTH AND 2 CM IN DIAMETER. IT IS DULL. NO BLOOD OR TISSUE ELEMENTS ARE IDENTIFIED. REP. SECTIONS ARE EMBEDDED UNDER MD-926. RECEIVED IN FORMALIN ARE TWO SEGMENTS OF CRIMPED DACRON VASCULAR GRAFT WHICH MEASURE UP TO 6 CM IN LENGTH BY 1 CM IN DIAMETER. THE SURFACES ARE DARK BROWN IN APPEARANCE. NO GROSS BLOOD ELEMENTS OR TISSUE FRAGMENTS ARE IDENTIFIED. REP. SECTIONS ARE EMBEDDED UNDER MD-927 AND MD-928. MICROSCOPIC DESCRIPTION: HEMASHIELD DACRON GRAFT WITH COLLAGEN COATING IS IDENTIFIED. THE THREE SEGMENTS ARE SIMILAR IN MICROSCOPIC APPEARANCE. NO LOSS OF INTEGRITY OF THE COLLAGEN COATING IS IDENTIFIED. THE COLLAGEN COATING IS PRESENT ON THE LUMINAL SURFACE, WITHIN THE INTERSTICES OF THE DACRON FABRIC, AND ON THE PERIADVENTITIAL (OUTER) SURFACE. NO BLOOD OR TISSUE ELEMENTS ARE IDENTIFIED. SUMMARY: THREE SEGMENTS OF HEMASHIELD DACRON VASCULAR GRAFT WITH INTACT COLLAGEN COATING ARE IDENTIFIED.
FIRST RESPONDER EMT ENGINE CO RESPONDED TO LOCATION OF A 66-YR-OLD MALE IN FULL CARDIAC ARREST. A SEMI-AUTOMATIC DEFIBRILLATOR WAS IMMEDIATELY APPLIED. WHEN THE ANALYZE BUTTON WAS PUSHED TO AED STATED, "CHECK PT", INDICATING THAT THE CARDIAC RHYTHM THAT THE AED WAS READING WAS NOT SHOCKABLE. UPON ARRIVAL OF PARAMEDIC UNIT, PARAMEDICS USED ANOTHER CARDIAC MONITOR-DEFIBRILLATOR TO VERIFY HEART RHYTHM. THE FINDINGS INDICATED THAT THE PT WAS EXPERIENCING VENTRICULAR FIBRILLATION. PT WAS SUBSEQUENTLY DEFIBRILLATED NUMEROUS TIMES BY PARAMEDICS USING THE SECOND DEVICE. THE AED FAILED TO RECOGNIZE VENTRICULAR FIBRILLATION.
DURING AN ESOGHAGO-JEJUNOSTOMY PROCEDURE, THE INSTRUMETN DID NOT FIRE PROPERLY. THE SURGEON REMOVED THE SUTURE AND CLOSED THE SITE MANUALLY.
CATHETER BALLOON WOULD NOT DEFLATE. CUT CATHETER ARM TO NO AVAIL. INJECTED ADD'L 10-15 CC'S OF FLUID AND 10 CC'S OF MINERAL OIL TO NO AVAIL. INJECTED ADD'L 10-15 CC'S OF FLUID AND 10 CC'S OF MINERAL OIL WITHOUT RESULTS. BLADDER WAS FILLED WITH WATER AND CATHETER BALLOON WAS INFLATED WITH ADD'L 60 CC'S FLUID WHICH RESULTED IN BALLOON RUPTURE, NO PIECES APPEAR TO BE MISSING. CATHETER WAS REPLACED WITHOUT FURTHER COMPLICATIONS. CATHETER WAS INDWELLING FOR 6 WEEKS AT TIME OF REMOVAL.
ACCORDING TO THE INFO THAT CO RECEIVED VIA A MEDWATCH REPORT, ON AUG 12, 1996, THE PTCA BALLOON RUPTURED WITH HIGH PRESSURE (25) ATM WITH DEVELOPMENT OF A PSEUDOANUERYSM CAUSING HYPOTENSION. THE PT HAD REPEAT ANGIO THE NEXT DAY FOR FOLLOW-UP. PER CO TELEPHONE CONVERSATION ON SEPT 30, 1996, AND THE PHYSICIAN'S CATH REPORT, THE 65 YR FEMALE PT HAD TWO 3.0    STENTS PLACED WITHIN THE RCA LESION AND REVASCULARIZATION OF HER BYPASS GRAFTS. A BALLOON CATHETER WAS USED INITIALLY, AFTER WHICH THE BALLOON CATHETER WAS INTRODUCED. UPON INFLATION OF THE BALLOON TO 25 ATMOSPHERES, A PINHOLE DEVELOPED WITH A DISSECTION. NO EXTRAVASATION OF CONTRAST WAS OBSERVED ON CINE. THE PT HAD SOME INITIAL CHEST PAIN, WHICH RESOLVED WITHOUT INTERVENTION. A BALLOON CATHETER WAS INSERTED AS A PRECAUTION. THERE WAS NO HEMODYNAMIC COMPROMISE OBSERVED. REPORTEDLY, THE PT HAD NO SEQUELAE AS A RESULT OF THE PINHOLE, AND WAS DISCHARGED ON AUG 15, 1996. CO SHOULD NOTE THAT THE RATED BURST PRESSURE FOR THIS BALLOON IS 16 ATMOSPHERES AND THIS PRESSURE WAS CLEARLY EXCEEDED DURING CLINICAL USE. SINCE THE PRODUCT WILL NOT BE RETURNED FOR EVAL AND TESTING, THIS FILE IS CONSIDERED CLOSED.
PTCA BALLOON RUPTURED WITH HIGH PRESSURE (25) ATM WITH DEVELOPMENT OF PSEUDOANEURYSM CAUSING HYPOTENSION. PT HAD REPEAT ANGIO THE NEXT DAY FOR FOLLOW-UP.
ON ULTRASOUND, THE 18MM GRAFT IS "DUMBELL-SHAPED," WITH ONE AREA 27MM IN DIAMETER AND ANOTHER AREA 22MM IN DIAMETER. THE PT IS ASYMPTOMATIC, BUT CAN FEEL A PULSATILE MASS IN ABDOMEN.
AT THIS TIME, THERE IS NO PRODUCT TO BE RETURNED FOR EVAL, THEREFORE THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MANUFACTURING BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-SO SIMILAR COMPLAINTS AGAINST THIS BATCH.
THE PT, A TYPE II DIABETIC ON INSULIN INJECTIONS, REPORTED HIGHER BLOOD GLUCOSE READINGS WITH CO'S DEVICE. ON 9/14/96 AT APPROX 7:00AM, THE PT OBTAINED A FASTING BLOOD GLUCOSE OF APPROX 200 MG/DL. HE ADMINISTERED 28 UNITS OF REGULAR INSULIN BASED ON HIS SLIDING SCALE. HIS SLIDING SCALE INSULIN REGIMENT IS AS FOLLOWS: IF BLOOD GLUCOSE IS FROM 61-100 MG/DL, HE ADMINISTERES 5 UNITS. IF BLOOD GLUCOSE IS FROM 101-150 MG/DL, HE ADMINISTERS 10 UNITS. IF BLOOD GLUCOSE IS OVER 200 MG/DL 28 UNITS. ALL INSULIN ADMINISTERED IS REGULAR INSULIN. EVEN THOUGH THE PT TOOK HIS INSULIN, HE DID NOT EAT ANYTHING UNTIL APPROX 9:00 AM, 2 HOURS AFTER THE INJECTION. AT THIS TIME, HE HAD HYPOGLYCEMIC SYMPTOMS (I.E. DIZZY, LACK OF CONCENTRATION) SO HE ATE A "BIG BREAKFAST" (BISCUITS, EGGS, TOAST). HE DID NOT TAKE HIS BLOOD GLUCOSE AT THIS TIME AND DID NOT TAKE A READING AGAIN UNTIL 5:00 PM THAT NIGHT. AT APROX 3:00 PM, THE PT ATE "ONLY A SANDWICH." AT 5:00 PM, THE PT'S BLOOD GLUCOSE WAS 338 MG/DL. THE PT FEELS THAT HE OBTAINED HIGHER READINGS WITH CO'S DEVICE AND, FOR THIS REASON, ADMINISTERED "TOO MUCH INSULIN" WHEN HE GAVE HIMSELF THE 28 UNITS. SOME TIME THIS WEEK, THE PT WENT TO HIS PHYISICAN FOR A ROUTINE CHECK UP AND PERFORMED A SIDE BY SIDE BLOOD GLUCOSE COMPARISON WITH THE PHYSICIAN'S METER AND CO'S DEVICE STRIPS AND HIS METER AND CO'S DEVICE. THE RESULTS WERE 173 AND 338 MG/DL RESPECTIVELY. THE DESICCANT IS IN THE BOTTLE OF CO'S DEVICE. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE PT DOES NOT HAVE NORMAL CONTROL SOLUTION. THE PT PERFORMED A CHECK STRIP TEST ON HIS METER SOME TIME THIS WEEK AND OBTAINED A RESULT WITHIN THE CHECK STRIP RANGE. HE WOULD NOT PERFORM A CHECK STRIP TEST WITH THE REPRESENTATIVE. THE PT USED THE REMAINDER OF THE TEST STRIPS. FOR THIS REASON, HE CANNOT RETURN THEM TO CO FOR EVALUATION. HE STORES HIS TEST STRIPS IN HIS KITCHEN.
BASED ON CUSTOMER COMPLAINT REPORT, CUSTOMER WAITED FOR 2 HOURS TO HAVE BREAKFAST (9:00AM) AFTER INJECTION OF INSULIN ACCORDING TO A FASTING BLOOD GLUCOSE READING (7:00 AM). THE HYPOGLYCEMIC SYMPTOMS MAY BE DUE TO CUSTOMER WAITING TOO LONG TO HAVE BREAKFAST. CUSTOMER STATED THAT HE ATE A SANDWICH AT 3:00 PM, AND HE DID NOT TAKE A READING AGAIN UNTIL 5:00 PM AND THE RESULT WAS 338 MG/DL. THEREFORE, IT IS PROBABLE THAT HIS BLOOD GLUCOSE STAYED HIGH BECAUSE OF THE BIG BREAKFAST AND SANDWICH. ERROR GRID ANALYSIS INDICATES THAT CUSTOMER'S TEST STRIPS MAY PRODUCE RESULTS WHICH FALL IN ZONE C, AND PRESENT A REASONABLE RISK OF SERIOUS INJURY. HOWEVER, CUSTOMER DID NOT RUN COMPARISON WITH AN ACCEPTABLE REFERENCE METHOD. PRODUCT SHOULD NOT BE COMPARED TO OTHER TEST STRIPS WHICH THEMSELVES MAY BE INACCURATE. CUSTOMER STATED THAT HE USED THE REMAINDER OF THE CO'S TEST STRIPS. THEREFORE, NO CUSTOMER'S TEST STRIPS ARE AVAILABLE FOR EVALUATION. THE RETENTION SAMPLE TEST RESULTS FOR DEVICE MEET THE SPECIFICATIONS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. TREND ANALYSIS OF COMPLAINTS SHOWS THIS IS THE FIRST COMPLAINT FOR DEVICE. BASED ON THE EVALUATION OF RETENTION SAMPLES, THE RISK OF PRODUCT FAULURE IN THE FIELD IS LOW. IS THE EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? U. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUSAL FOR DEVICE? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? U. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N.
THE DEVICE WAS NOT CLINICALLY APPLIED. THE INSTRUMENT BROKE DURING PREPARATION FOR SURGERY.
10/3/96-MEDWATCH NOT RECEIVED BY MFR. SUBMITTED INITITAL REPORT.
EMPLOYEE ALLEGES: DISCARDING OF USED NEEDLES IN SHARPS; LID JAMMED CAUSING NEEDLESTICK TO LEFT THUMB.
METHOD/RESULTS/CONCLUSIONS: DEVICE NOT RETAINED BY USER FACILITY. NO EVALUATION COULD BE COMPLETED. NO LOT SPECIFIC OR DEVICE CODE INFO AVAILABLE FROM USER FACILITY. HOWEVER, REPORTED EVENT NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THIS TYPE OF DEVICE.
EMPLOYEE ALLEGES: PICKING UP CLOSED NEEDLE BOX, SUSTAINED NEEDLESTICK TO RIGHT THUMB.
METHOD/RESULTS/CONCLUSIONS: DEVICE NOT RETAINED BY USER FACILITY. NO EVALUATION COULD BE COMPLETED. NO LOT SPECIFIC INFO OR DEVICE CODE INFO AVAILABLE FROM USER FACILITY. HOWEVER, REPORTED EVENT NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THIS TYPE OF DEVICE.
THE PATCH WAS IMPLANTED AS A CARTOID PATCH WITHOUT BEING PRECLOTTED, AND LEAKED BLOOD (QUANTITY UNKNOWN). ADD'L HEMOSTATIC AGENTS WERE GIVEN AND THE PATCH EVENTUALLY BECAME BLOOD-TIGHT AND WAS LEFT IN. THE LENGTH OF SURGERY WAS STATED TO HAVE BEEN EXTENDED AN EXTRA FOUR HRS WITH MULTIPLE UNITS OF BLOOD AND PLATELETS GIVEN DUE TO THE LEAKAGE. THE HOSPITAL STATES THAT THE PT WAS NOT INJURED AND THE PT'S CONDITION IS OK. BASED UPON THE ABOVE, THIS IS A USER ERROR COMPLAINT SINCE THE DR DID NOT PRECLOT THE FABRIC, CONTRARY TO THE INSTRUCTIONS FOR USE.
EXAMINATION AND WATER POROSITY TESTING THE RETURNED, REMAINING, UNUSED PRODUCTS DID NOT CONFIRM ANY PROBLEM WITH THE FABRICS; ALL TEST RESULTS WERE WITHIN LABEL SPECIFICATIONS. NO PRODUCT ERROR IS FOUND. ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. CODE 86: THE MANUFACTURING BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-ONE SIMILAR COMPLAINT AGAINST THIS BATCH.
THE CORD EMITTED SPARKS. CO'S INSPECTION REVEALED A BREAK IN THE LINE CORD AT THE BUTTERFLY. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS ADDED A CAUTION TO THE LABELLING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED.
THIS EVENT IS NOT CONSIDERED REPORTABLE UNDE 21 CFR 803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SEIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
THE SWITCH EMITTED SPARKS. CO'S INSPECTION REVEALED A BREAK IN THE LINE CORD AT THE STRAIN RELIEF. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS ADDED A CAUTION TO THE LABELLING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED.
THIS EVENT IS NORT CONSIDERED REPORTABLE UNDER 21 CFR 803, BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SEIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
DURING AN ARCH AORTIC GRAFT REPLACEMENT FOR A DISSECTING AORTIC ANEURYSM IN A 59 YR OLD FEMALE, THE GRAFT "OOZED" BLOOD OVER A PERIOD OF FOUR HRS. THE EXACT QUANTITY OF BLOOD LOST THROUGH THE GRAFT IS NOT ATTAINABLE BY TREATING THE PT WITH BLOOD PLATELETS, FRESH BLOOD, FRESH FROZEN PLASMA TRANSFUSION, AND APPLYING FIBRIN GEL. THE PT'S CONDITION IS REPORTED AS FAVORABLE OF 8/5/96.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD THIS INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-NO SIMILAR COMPLAINT AGAINST THIS BATCH.
THE PATCH WAS IMPLANTED AS A CAROTID PATCH WITHOUT BEING PRECLOTTED AND LEAKED BLOOD (QUANTITY UNKNOWN). ADD'L HEMOSTATIC AGENTS WERE GIVEN AND THE PATCH EVENTUALLY BECAME BLOOD-TIGHT AND WAS LEFT IN. THE LENGTH OF SURGERY WAS STATED TO HAVE BEEN EXTENDED AN EXTRA HR WITH TWO UNITS OF BLOOD GIVEN DUE TO THE LEAKAGE. THE HOSPITAL STATES THAT THE PT WAS NOT INJURED AND THE PT'S CONDITION IS UNKNOWN. BASED UPON THE ABOVE, THIS IS A USER ERROR COMPLAINT SINCE THE DR DID NOT PRECLOT THE FABRIC, CONTRARY TO THE INSTRUCTIONS FOR USE.
EXAMINATION AND WATER POROSITY TESTING THE RETURNED, REMAINING, UNUSED PRODUCTS DID NOT CONFIRM ANY PROBLEMS WITH THE FABRICS; ALL TEST RESULTS WERE WITHIN LABEL SPECIFICATIONS. NO PRODUCT ERROR IS FOUND. ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. CODE 86: THE MANUFACTURING BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-ONE SIMILAR COMPLAINT AGAINST THIS BATCH.
WHEN THE TUBING WAS PLACED ON THE PUMP, THE PUMP CONTINUOUSLY ALARMED "OCCLUDED;" WHEN THE TUBING WAS REMOVED FROM THE PUMP, THE PLUNGER IN THE CASSETTE WOULD NOT DEPRESS TO ALLOW A FREE FLOWING IV SOLUTION; A SECOND SET WAS USED WHICH HAD THE SAME PROBLEM; A THIRD IV SET FUNCTIONED PROPERLY. TUBING WAS BEING USED TO ADMINISTER A STAT ANTIBIOTIC TO AN UNSTABLE CCU PT, THIS PROBLEM RESULTED IN A DELAY OF THE ANTIBIOTIC TO THE PRESCRIBED DOSE DUE TO THE LOSS OF ANTIBIOTIC IN THE TWO DEFECTIVE IV SETS DURING THE PRIMING OF THE SETS.
DURING A PROCEDURE, THE END HUB OF THIS SUCTION TUBE FELL OFF.
SECTION A THROUGH F WERE COMPLETED BY THE MFR. EVAL. INDICATED LOOSE FITTINGS AT THE HUB AND SHAFT. THE WELD CAME LOOSE.
THE SWITCH EMITTED SPARKS. CO'S INSPECTION REVEALED A BREAK IN THE AN OLD-STYLE LINE CORD. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS ADDED A CAUTION TO THE LABELLING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED.
THE SWITCH EMITTED SPARKS. CO'S INSPECTION REVEALED A BREAK IN THE AN OLD-STYLE LINE CORD. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS ADDED A CAUTION TO THE LABELLING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED.
A PT WAS BEING PACED WITH THE DEVICE WHILE BEING LOADED FOR TRANSPORT TO THE HOSP. REPORTEDLY, THE PACER CONNECTOR MODULE CAME APART AT THIS TIME, WHICH PULLED THE INTERNAL PACER HARNESS OUTSIDE OF THE DEVICE CASE. THIS REPORTEDLY RESULTED IN CESSATION OF PACING AND AA PACING LEADS OFF ALARM.
THE LOCAL FACTORY SERVICE REPRESENTATIVE REPLACED THE DEVICE PACER CONNECTED MODULE, P/N 805139-02. THE DEVICE WAS REASSEMBLED AND OBSERVED TO OPERATE PROPERLY, THROUGH FULL FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE EXHIBITED REDUCED POWER. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
INTRAVENOUS FLUID WOULD NOT FLOW THROUGH CONNECTOR. UPON VISUAL EXAMINATION, THE FLUID PATH OF THE DEVICE NEEDLE APPEARS TO BE PHYSICALLY BLOCKED BY A PIECE OF TRANSLUCENT PLASTIC, APPROX 1 MM WIDE, AND OF UNDETERMINED LENGTH.
PT WAS IMPLANTED WITH A LENS THAT HAD BEEN CALCUATED USING THIS OPHTHALMIC A-SCAN. POST OPERATIVE EVAL OF THE PT FOUND THE VISION TO BE 3.5 TO 4.0 DIOPTERS OFF. PT'S VISION IS CORRECTABLE WITH GLASSES. NO LENS EXCHANGE IS PLANNED AT THIS TIME.
THE USER WILL RECEIVE AN ADDITIONAL TRAINING.
PT UNDERGOING CATARACT SURGERY. DURING THE EMULSIFICATION, IT WAS NOTED THAT METAL PARTICLES WERE BEING DEPOSITED INSIDE THE EYE FROM THE PHACO HANDPIECE. A NEW HANDPIECE WAS OBTAINED FOR REMAINDER OF CASE. EYE WAS VACUUMED/IRRIGATED TO REMOVE PARTICULATE.
THE UNIT CAUGHT FIRE. CO'S INSPECTION REVEALED THE HEATER WIRE HAD DISLODGED CAUSING A 4" DIAMETER BURN HOLE THROUGH THE PAD AND ONE SIDE OF THE COVER. NO DEATHS OR INJURIES WERE REPORTED.
THIS CATHETER WAS BEING UTILIZED FOR A DIAGNOSTIC CARDIOLOGY PROCEDURE WHEN IT LEAKED AT THE HUB/STRAIN RELIEF JUNCTION. THERE WAS NO REPORTED INJURY TO THE PT.
THE INFO PROVIDED IN SECTTION F WAS SUPPLIED BY MALLINCKRODT INC. THIS SUBMISSION CORRECTS THE INTO ORIGINALLY PROVIDED IN SECTION D.
DURING A DILATATION PROCEDURE, THE CATHETER BALLOON RUPTURED USING A SYRINGE FOR INFLATION PURPOSES. THE CATHETER WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITH NO PT INJURY REPORTED.
BLOCK B6 & B7 WERE CHANGED TO "UNK" AS SEVERAL ATTEMPTS WERE MADE WITH NO AVAIL TO OBTAIN THE INFO BLOCK H6, METHOD CODE 86, CHOSEN BECAUSE THERE WAS NO METHOD POSSIBLE TO PERFORM AN EVAL DUE TO THE SUSPECT DEVICE BEING DISCARDED BY THE USER. CODE 2199-NOT LABELED.CODE 1049-LABELED. BLOCK G1, SITE LOCATION, WAS INCORRECT ON THE INITIAL REPORT; INFO CHANGED ON THIS FOLLOW-UP REPORT TO REFLECT THE CORRECT LOCATION.
THE UNIT BURNED, THE UNIT HAS NOT BEEN RETURNED TO CO FOR INSPECTION AND MAY NOT BE. NO DEATHS OR INJURIES WERE REPORTED. COMMUNICATION WITH THE USER REVEALED THE USER LAID ON THE UNIT WHICH WAS CONTRARY TO THE INSTRUCTION BOOKLET.
FIVE SECONDARY SETS DID NOT HAVE PATENT NEEDLE LOCK DEVICE.
SECTIONS A-F WERE COMPLETED BY THE MFR. DATE ENTERED IN SEC F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. SECTION F.9 IS DATE USER BECAME AWARE OF THE FAILURE.
NO EKG DISPLAY ON MONITOR. PT CABLE AND EKC MODULE CHANGED, BUT PROBLEM NOT CORRECTED. ELECTRODES CHANGED X3, BUT STILL NO EKG. REPLACED ELECTRODES WITH ANOTHER BRAND AND PROBLEM CORRECTED.
PT WAS IMPLANTED WITH A LENS THAT HAD BEEN CALCULATED USING THIS OPHTHALMIC A-SCAN. POST OPERATIVE EVAL OF THE PT FOUND THE VISION TO BE 3-5 TO 4.0 DIOPTERS OFF. PT'S VISION IS CORRECTABLE WITH GLASSES. NO LENS EXCHANGE IS PLANNED AT THIS TIME.
THE PLASTIC CLIP ON THE HEAD REST CAME UNDONE CAUSING THE PT TO SLUMP IN THE SLING. THE NURSE WAS ABLE TO STEADY THE PT AND INJURY WAS NOT SUFFERED. SIZE OF SLING WAS LARGE GREEN. ONE PERSON INVOLVED NO INJURY.
FOREIGN REPORTER AS FOLLOWS: ARJO LTD. ST CATHERINE ST. GLOUCESTER, ENGLAND. GL12SL. FOREIGN REPORTER HAS ASSIGNED INVESTIGATOR, AND IS TO FORWARD CLOSING OUT REPORT. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y./ WILL ADDITIONAL INFO BE PROVIDED AFTER 15-DAY REPORT? N. THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21 CFR 600, 803, 1002, 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
THE OBTURATOR BROKE DURING INSERTION. A NEW TRACHEOSTOMY TUBE WAS USED WITHOUT FURTHER INCIDENT. NO PT INJURY WAS REPORTED. NO INFO WAS PROVIDED REGARDING THE TYPE OF PROCEDURE INVOLVED.
PCR #96-248-01. IS THE FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? N. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? N. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
DURING A CATARACT EXTRACTION PROCEDURE, THE FOOT PEDAL FOR THIS OPHTHALMIC MICROSURGICAL UNIT WAS STICKING. THE FOOT PEDAL WAS EXCHANGED FOR ANOTHER AND THE PROCEUDURE, WAS SUCCESSFULLY COMPLETED.
STAFF FOUND THE PT ON THE FLOOR. A BED ALARM WAS IN PLACE BUT DID NOT ACTIVATE. SINCE 8/1/96 INVESTIGATION INDICATES THAT THERE HAVE BEEN SEVEN (7) OTHER SEPARATE BUT SIMILAR INCIDENTS WHICH HAVE OCCURRED WHERE THE BED ALARM DEVICE DID NOT ACTIVATE PROPERLY. THE PRODUCT PROBLEM INVOLVES THE BED ALARM DEVICE EITHER NOT ALARMING AT ALL OR THE ALARM ACTIVATION IS SIGNIFICANTLY DELAYED. IN AN ACTUAL TEST OF A DEVICE THAT DID MALFUNCTION, THERE WAS A 4 1/2 DELAY.
PT WAS IMPLANTED WITH A LENS THAT HAD BEEN CALCULATED USING THIS OPHTHALMIC A-SCAN. POST OPERATIVE EVAL OF THE PT FOUND THE VISION TO BE 3.5 TO 4.0 DIOPTERS OFF. PT'S VISION IS CORRECTABLE WITH GLASSES. NO LENS EXCHANGE IS PLANNED AT THIS TIME.
EMS PERSONNEL RESPONDED TO A PERSON DESCRIBED AS PULSELESS AND ANEIC. CPR WAS PERFORMED AND THE PT WAS CONNECTED TO THE DEVICE WITH DISPOSABLE DEFBRILLATION/ECG ELECTRODES. CPR WAS STOPPED AND THE ANALYZE BUTTON WAS PRESSED BUT, ACCORDING TO THE REPORTER, THE DEVICE ALARMED AND AN ATTACH DEFIB CABLE MESSAGE WAS DISPLAYED ON THE DEVICE'S SCREEN. THE PT'S ECG APPEARED TO BE ASYSTOLE WITH A SMALL AMOUNT OF PULSELESS ELECTRICAL ACTIVITY (PEA). APPROX 5 MINUTES LATER, PARAMEDICS ARRIVED AND TOOK CONTROL OF THE PT WITH A BACKUP DEFIBRILLATOR/MONITOR. THE PT WAS NOT RESUSCITATED. THE REPORTER INDICATED THE REPORTED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PT. THE PT WAS NOT RESUSCITATED. THE REPORTER BASED THEIR OPINION ON THE ATTENDING PARAMEDIC'S ASSESSMENT OF THE PT'S VIABILITY, THE IMMEIDATE AVAILABLITY AND USE OF A BACK UP DEFIBRILLATOR/MONITOR AND THAT THE PT HAD BEEN DOWN FOR APPROX 20 MINUTES BEFORE ARRIVAL OF THE EMS TEAM.
IN AN EVALUATION, THE FACILITY CHECKED THE DEVICE ON THE DAY FOLLOWING THE REPORTED EVENT AND OBSERVED PROPER OPERATION. THE DEFIBRILLATION CABLE WAS REPLACED TO MAINTAIN CUSTOMER CONFIDENCE. THE REPLACED CABLE IS BEING RETAINED BY THE FACILITY AND IS NOT AVAILABLE FOR EVALUATION.
USING A 4-LEAD CABLE ON TELEMETRY TRANSMITTER, THE SYSTEM MONITORS TWO ECG WAVE FORMS. WHEN CHANGING THE LEAD TO MONITOR IN A SECONDARY WAVEFORM THE LEAD LABEL CHANGES, BUT THE PREVIOUS WAVE FORM STAYS ON THE SCREEN. THE END RESULT IS THAT THE WAVE FORM IS MISLABELED.
THE CATHETER BROKE OFF THE BURETTE. THE REPORTER INDICATED THAT THIS HAS OCCURRED ON THREE OTHER OCCASIONS BUT DID NOT PROVIDE SPECIFIC DETAILS.
CUSTOMER INDICATED SAMPLES WOULD BE RETURNED TO CO FOR EVAL. SAMPLES HAVE NOT YET BEEN RECEIVED. LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. CO WAS UNABLE TO CONFIRM THIS ISSUE WITHOUT BENEFIT OF RETURNED PRODUCT EVAL. CO IS AWARE OF THIS ISSUE FROM A PREVIOUS COMPLAINT AND HAS BEEN ABLE TO DUPLICATE THIS IN HOUSE. CO'S MANUFACTURING ENGINEERING DEPT IS CURRENTLY INVESTIGATING CHANGES IN THE SOLVENTING PROCESS TO ELIMINATE THIS ISSUE. AN ADD'L REPORT WILL BE PROVIDED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF CO'S EVAL.
THE USER WILL RECEIVE AN ADDITIONAL TRANING.
THE GRAFT OOZED BLOOD, WITH HEAVY BLEEDING FROM THE CROTCH AREA (QUANTITY OF BLOOD UNKNOWN). THE PT'S CONDITION IS FINE.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" HAVE NO INFO AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-NO SIMILAR COMPLAINTS AGAINST THIS BATCH. ADD'L NOTE: ALTHOUGH THERE ARE NO SIMILAR COMPLAINTS AGAINST THIS BATCH, THE MFR HAS IMPLEMENTED A VOLUNTARY RECALL BASED UPON A REASSESSMENT OF THE POROSITY DATA FOR THIS BATCH.
RESIDENT PUSHED AND WEDGED HEAD THROUGH BARS OF SIDERAIL. STAFF MEMBERS WERE REQUIRED TO DISLODGE HEAD.
DURING A KISSING BALLOON DILATATION PROCEDURE, BOTH CATHETER BALLOONS RUPTURED BEFORE 4 ATM. EACH CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE AND BOTH BALLOONS AGAIN RUPTURED BEFORE 4 ATM. AS THE HOSP'S STOCK HAD BEEN DEPLETED, THE PROCEDURE WAS STOPPED. NO PT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.
CODE 2199 - NOT LABELED. CODE 1049-LABELED.
THE PORT BROKE OFF DURING TRANSFUSION. THE REPORTER INDICATED THAT THIS HAD OCCURRED ON MULTIPLE OCCASIONS BUT DID NOT PROVIDE SPECIFIC DETAILS.
CUSTOMER INDICATED SAMPLES WOULD BE RETURNED TO CO FOR EVAL. SAMPLES HAVE NOT YET BEEN RECEIVED. RETAIN PRODUCT SAMPLES WERE EVALUATED AND WERE FOUND TO BE ACCEPTABLE. LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVAL. ADD'L REPORT WILL BE PROVIDED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF MEDEX'S EVAL.
PT WAS IMPLANTED WITH A LENS THAT HAD BEEN CALCULATED USING THIS OPHTHALMIC A SCAN. POST OPERATIVE EVAL OF THE PT FOUND THE VISION TO BE 3.5 TO 4.0 DIOPTERS OFF. PT'S VISION IS CORRECTABLE WITH GLASSES. NO LENS EXCHANGE IS PLANNED AT THIS TIME.
TWO BALLOONS RUPTURED BELOW 12 ATMS DURING A SUPERFICIAL FEMORAL ANGIOPLASTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS.
F10. 1049-LABELED. 2203-PT CONDITION, CALCIFICATION, MAY HAVE CONTRIBUTED TO EVENT.
WOULDN'T FIRE. DR CUT AND STAPLES "LOOK FUNNY."
THE ANGULATION DRIVE CHAIN FAILED, ALLOWING THE TABLE TO DROP ON THE FLOOR. APPARENTLY THIS OCCURRED WHEN THE TABLE WAS IN THE VERTICAL POSITION WITH THE PT ON THE TABLE. EVIDENTLY THIS RESULTED IN SORENESS IN THE PT'S FOOT; NO SERIOUS INJURY OCCURRED.
UPON TERMINATION OF AN ABDOMINAL CAT SCAN, THE PT MANIFESTED HIVES WITHOUT PRURITUS. 50 MG BENADRYL GIVEN IV WITH NO FURTHER PROGRESSION.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE FAILED TO CALIBRATE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
THE ARCHIVING SOFTWARE CAN MERGE 2 PT IMAGE FILES INTO ONE. APPARENTLY, THE PT INFO CAN BE LOST FOR 1 PT AND BOTH SETS OF IMAGES WILL BE DISPLAYED FOR THE OTHER PT. NO EVENT HAS BEEN REPORTED.
AT END OF AN ABDOMINAL CT, PT DEVELOPED RASH ON HER CHEST AND ALSO FELT THAT HER BREATHING WAS BECOMING A LITTLE DIFFICULT. AT THIS TIME PT WAS GIVEN 50 MG BENADRYL IV. AS A RESULT, HER SYMPTOMATOLOGY DISAPPEARED.
THE PORT BROKE OFF DURING BLOOD TRANSFUSION. THE REPORTER INDICATED THAT THIS HAD OCCURRED ON MULTIPLE OCCASIONS BUT DID NOT PROVIDE SPECIFIC DETAILS.
CUSTOMER DID NOT INDICATED IF SAMPLES WOULD BE RETURNED TO CO FOR EVAL. SAMPLES HAVE NOT BEEN RECEIVED. LOT HISTORY REVIEW WAS NOT AVAILABLE AS THE LOT NUMBER WAS UNKNOWN TO THE CUSTOMER. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVAL. ADD'L REPORT WILL BE PROVIDED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF CO'S EVAL.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS REC'D. SECTION F9 IS DATE USER BECAME AWARE OF THE FAILURE.
AN INTRA CORONARY STENT WAS LOST IN THE PT. AFTERWARDS THE STENT COULD NOT BE DEPLOYED.
THE DEVICES IN QUESTION WERE TESTED ON A SYSTEM 6000 ELECTROSURGICAL UNIT. THE CUT AND COAG FUNCTIONS TESTED WITHIN SPEC. COULD NOT DUPLICATE OR CONFIRM FAILURE MODE. NO EVIDENCE OF PRODUCT DEFECT WAS FOUND.
HYPERAL RUNNING AT 6 CC/HR. RN NOTED NO VOLUME CHANGE IN IV BAG OVER 8-10 HRS. PROBLEM IDENTIFIED AFTER NEW SHIFT CHANGED. PUMP WAS RUNNING AND REGISTERED CORRECT AMOUNT, HOWEVER, NO FLUID HAD INFUSED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS REC'D. DATE OF EVENT WAS NOT REPORTED.
THE BOLT AND NUT LOOSENED IN THE VERTICAL ARM MOUNT. THIS CAUSED THE ARM AND INJECTOR HEAD TO FALL. NO INJURY OCCURRED.
THE HEXAGON NUT THAT ATTACHES TO THE SOCKET CAP SCREW IN THE VERTICAL ARM LOOSENED. WHEN THE NUT LOOSENED THE VERTICAL ARM ASSEMBLY THAT HOLDS THE INJECTOR HEAD, AND THE INJECTOR HEAD, FELL. CAUSE FOR THIS IS UNK. THE MFR WILL BE NOTIFIED AND ANY NECESSARY CORRECTIVE ACTION PURSUED.
A BALLOON RUPTURED AT 8 ATMS WHILE DILATING A TOUGH VENOUS ANASTOMOSIS GRAFT LESION IN A HEMODIALYSIS PT. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. TWO DEVICES WERE RECEIVED, EVALUATED AND RETAINED BY THIS MFR. MICROSCOPIC EXAM OF THE FIRST BALLOON REVEALED A 2MM CIRCUMFERENTIAL TEAR LOCATED 7MM DISTAL TO THE PROXIMAL RO MARKER. MICROSCOPIC EXAM OF THE SECOND BALLOON REVEALED A PINHOLE LEAK LOCATED 17MM DISTAL TO THE PROXIMAL RO MARKER. THE SHAFT UNDER THE BALLOON WAS BOWED. SCRATCHES AND WRINKLES WERE FOUND ON THE SURFACES OF BOTH BALLOONS. ALTHOUGH CO'S FOLLOW UP INDICATED THE SECOND BALLOON WAS USED SUCCESSFULLY, BOTH BALLOONS WERE FOUND TO HAVE LEAKS UPON EVALUATION. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVER-PRESSURUZATION OR USE IN A CALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFCICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. ONE OF THE DEVICES DISPLAYED CHARACTERISTICS CONSISTENT WITH OVERPRESSURIZATION, A BOWED SHAFT UNDER THE BALLOON. BOTH DEVICES DISPLAYED CHARACTERISTICS CONSISTENT WITH A SHARP EXTERNAL SOURCE, SCRATCHES ON THE BALLOON SURFACE. THEREFORE, CO BELIEVES THESE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICES.
HYPERAL IN D20 RUNNING AT 1.8 CC/HR PRECIPITOUS GLUCOSE DROP NOTED BY RN. RN ASSUMED IV PUMP DID NOT INFUSE. SEVERE HYPOGLYCEMIA REQUIRING INSULIN AND DEXTROSE TITRATION.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY & QUANTITY AS CAUSE FOR FAILURE. IMPLANT WAS PLACED IN EXTRACTION SITE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES THAT CAUSE FOR FAILURE IS UNKNOWN. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
TWO SIZE 9 SCT TRACHEOSTOMY TUBES TORE AT THE DISTAL END OF THE CUFF DURING INSERTION IN AN INITIAL TRACHEOSTOMY. BOTH DEVICES WERE TESTED PRIOR TO USE AND WERE FINE. A THIRD DEVICE WAS INSERTED WITHOUT FURTHER INCIDENT. NO PT INJURY WAS REPORTED.
PLEASE NOTE: THIS IS A FOLLOW-UP REPORT TO PROVIDE EVAL RESULTS (SECTION H6) AND EVENT PROBLEM CODES (SECTION F10), WHICH HAVE BEEN PROVIDED BY THE MFR. AN EVAL OF THE PRODUCT, WHICH WAS RECEIVED ON 9/12/96, VERIFIED THAT THERE WAS A SLIT AT THE DISTAL END OF BOTH CUFFS, WHICH LIKELY OCCURRED DURING USE. DEVICE HISTORY RECORDS REVEAL THAT ALL THE PRODUCTS HAD BEEN 100% INSPECTED FOR INFLATION SYSTEM INTEGRITY AND CONFIRMED TO BE ACCEPTABLE PRIOR TO RELEASE.
INVESTIGATION CONDUCTED. DR CITES THE CAUSE FOR FAILURE AS UNKNOWN. PT DOES NOT HAVE CONTROLLED HYPERTENSION. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT OF THE IMPLANT FROM THE TEMPORARY PROSTHESIS AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES THAT HE IS UNSURE OF CAUSE FOR FAILURE. PT HAS DIABETES. THIS CASE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERIYT THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR IS UNSURE OF CAUSE FOR FAILURE. PT SMOKES SOME TIMES. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
INVESTIGATION CONDUCTED. DR CITES POOR ORAL HYGIENE & THE FACT THAT THE PT SMOKES & DRINKS ALCOHOL HAS CAUSE FOR FAILURE. PT IS ALSO A BRUXOR. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
SCISSOR BROKE OFF IN THE NOSE OF A PT DURING A PROCEDURE.
NS RUNNING VIA UMBILICAL ARTERIAL LINE AT 3CC/HR. WAVEFORM DAMPENED AFTER APPROX 10 HRS. UAC WAS EVENTUALLY LOST; REPEATED ARTERIAL STICKS WERE REQUIRED. RN ASSUMED PUMP NON-INFUSION.
PERIPHERAL IV RUNNING AT 20CC/HR. TUBING HUNG ON 4/26/96. FOUND NOT INFUSING 2 DAYS LATER, UNKNOWN HOW LONG IT WAS OCCURRING. PERIPHERAL IV WAS LOST AND REQUIRED RESTARTING. RN ASSUMED PUMP NON-INFUSION.
PRODUCT WAS USED FOLLOWING A DIAGNOSTIC PROCEDURE. IT WAS REPORTED THAT THE DILATOR BENT WHEN REMOVED FROM THE TISSUE TRACT. OPERATOR CONTINUED TO DEPLOY COLLAGEN, FELT RESISTENCE AND THE SHEATH SEPARATED FROM THE HUB. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION WITH NO CLINICAL COMPLICATIONS.
CODE 86: EVALUATION OF EVENT BASED ON REVIEW OF MFG ND QC RECORDS, AND HISTORY OF THIS TYPE OF FAILURE. CODE 200: EXTREMELY LARGE ABDOMEN MADE IT DIFFICULT TO HOLD OCCLUSIVE PRESSURE WITHOUT PLACING HANDS TOO CLOSE TO PUNCTURE SITE. IF THE PASSAGE OF COLLAGEN IS RESTRICTED AND THE USER CONTINUES TO DEPLOY COLLAGEN, THE SHEATH CAN BE STRESSED TO THE POINT OF SEPARATION. THE IFU WARNS THAT IF RESISTANCE IS MET, THE PRODUCT PROCEDURE SHOULD BE ABORTED.
MEDEX CONFIRMED THE PRESENCE OF PM IN TWO OF THE THREE UNITS RETURNED FROM THIS FIRST COMPLAINT IN WHICH THREE INCIDENTS WERE IDENTIFIED. ONE WAS DETERMINED TO BE A SMALL, THIN, BLACK PARTICLE SIMILAR IN NATURE TO A SHORT HUMAN HAIR (POSSIBLY AN EYELASH) AND THE SECOND WAS A SMALL, CLEAR PARTICLE (POSSIBLY A SMALL PORTION OF THE PLASTIC SHRINK BANDING MATERIAL USED ON THE INJECTION CAP). THE HOSP BIOMEDICAL DEPT WAS ABLE TO DUPLICATE THE CLINICAL ISSUE ON THE FIRST COMPLAINT RECEIVED WHICH WERE THE ONLY SETS IN WHICH MEDEX WAS ABLE TO CONFIRM PM. IT FOLLOWS LOGICALLY THEN, THAT SINCE THE HOSP COULD NOT REPRODUCE THE DELIVERY PROBLEMS AND MEDEX COULD NOT CONFIRM THE PRESENCE OF PM EVEN WHILE FILTERING ALL RETURNED SETS, THE DELIVERY ISSUES WERE NOT NECESSARILY CAUSED BY THE PRESENCE OF PARTICULATE MATTER. AS A RESULT OF THE INITIAL COMPLAINT RECEIVED AND THE CONFIRMATION OF PM IN THE TWO RETURNED UNITS, MEDEX INSTITUTED SEVERAL CHANGES TO THE MFG PROCESS TO ELIMINATE POTENTIAL PM.
SCREWS THAT HOLD MOTOR MOUNTING PLATE AND BELT PULLEY ASSEMBLY PULLED OUT OF TAPPED EXTRUDED ALUMINUM OUTER PILLAR, OUTER PILLARE DROPPED AWAY.
COMPLETED INTERNAL EVALUATION OF INCIDENT, AWAITING DATE OF INCIDENT AND CUSTOMER SERVICE EVALUATION OF PILLAR. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS SEVERITY FOR THIS EVENT THAN IS USUAL? Y. ADD'L INFO WILL NOT BE PROVIDED AFTER 15-DAY REPORT. DISCLAIMER: THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21CFR600,803,1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHED THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
PRODUCT WAS USED FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE. DURING INSERTION OF THE COLLAGEN, THE SHEATH SEPARATED FROM THE HUB. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION WITH NO COMPLICAITONS TO THE PT.
CODE 86; EVALUATION OF EVENT BASED ON REVIEW OF MFG AND QC RECORDS, AND HISTORY OR THIS TYPE OF FAILURE. THIS INFO WAS REPORTED AS CUSTOMER COMPLAINT TO A CO. CODE 200: CO EXPERIENCE WITH THE PRODUCT HAS SHOWN CO THAT SHEATH SEPARATION CAN OCCUR WHEN THE PASSAGE OF COLLAGEN THROUGH THE SHEATH IS RESTRICTED. IF THE USER CONTINUES TO DEPLOY THE COLLAGEN THE SHEATH CAN BE STRESSED TO THE POINT WHERE A SEPARATION WILL OCCUR. RESTRICTIONS ARE USUALLY DUE TO DEFORMITIES IN THE SHEATH CAUSED DURING THE CLINICAL PROCEDURE.
SURGEON REPORTED TO AN IFM DISTRIBUTOR THAT THE CATHETER BALLOON BURST DURING SURGERY. THE LOT NUMBER OF THE DEVICE WAS NOT KNOWN AND THE DEVICE NOT RETURNED. THE DEVICE WAS USED TO OCCLUDE THE ILIAC ARTERIES FOR A GRAFT. PT HAD SEVERE ARTERIAL CALCIFICATION. THERE WAS NO PT INJURY. RETAINS FROM 3 SEPARATE LOTS OF PRODUCT FOR THIS MODEL WERE EVALUATED. ALL WERE FOUND TO MEET SPECIFICATION; NO DEFECTS WERE FOUND THAT WOULD CONTRIBUTE TO BALLOON FAILURE, OR ANY OTHER MFG DEFECT. CO CONCLUDES EITHER PT PRE-EXISTING CONDITION OR THE TYPE OF PROCEDURE PERFORMED CONTRIBUTED TO OR CAUSED THIS EVENT. THE POSSIBILITY OF BALLOON RUPTURE OR FAILURE DURING  A BALLOON CATHETERIZATION PROCEDURE OR RUPTURE OR RUPTURE/FAILURE DUE TO A SHARP CALCIFIED PLAQUE ARE ITEMS ADDRESSED IN THE PRODUCT INSERT UNDER PRECAUTIONS.
HYPERAL IN D30 RUNNING AT 7CC/HR. WHILE BLOOD GLUCOSE VALUES DECREASED OVER TIME, 8-16 HRS. DEXTROSE AND IV RATE TITRATED TO MAINTAIN APPROPRIATE GLUCOSE LEVELS. RN ASSUMED PUMP NON-INFUSION. PT IMPROVED AFTER PUMP AND TUBING WERE CHANGED. AGE AT TIME EVENT 1 WEEK.
PERIPHERAL IV HUNG AT 1500 ON 8/29 AT A RATE OF 15 CC/HR. PT DEMONSTRATED SIGNS OF DEHYDRATION (SIGNIFICANT). RN NOTED IV BAG STILL VERY FULL AT 1420 ON 8/30. PUMP AND TUBING CHANGED, AND THE PT IMPROVED OVER 1-2 DAYS. MULTIPLE BOLUS OF FLUID REQUIRED. RN ASSUMED PUMP NON-INFUSION. VITAL SIGNS: HR-180-190 RR-90'S, TEMP SPIKED, URINE OUTPUT: DECREASED, GLUCOSE: 37.
SURGEON REPORTED TO AN IFM DISTRIBUTOR THAT THE CATHETER BALLOON BURST DURING SURGERY. THE LOT NUMBER OF THE DEVICE WAS NOT KNOWN AND THE DEVICE NOT RETURNED. THE DEVICE WAS USED TO OCCLUDE THE ILIAC ARTERIES FOR A GRAFT. PT HAD SEVERE ARTERIAL CALCIFICATION. THERE WAS NO PT INJURY. RETAINS FROM 3 SEPARATE LOTS OF PRODUCT FOR THIS MODEL WERE EVALUATED. ALL WERE FOUND TO MEET SPECIFICATION; NO DEFECTS WERE FOUND THAT WOULD CONTRIBUTE TO BALLOON FAILURE, OR ANY OTHER MFG DEFECT. CO CONCLUDES EITHER PT PRE-EXISTING CONDITION ON THE TYPE OF PROCEDURE PERFORMED CONTRIBUTED TO OR CAUSED THIS EVENT. THE POSSIBILTY OF BALLOON RUPTURE OR FAILURE DURING A BALLOON CATHETERIZATION PROCEDURE OR RUPTURE/FAILURE DUE TO SHARP CALCIFIED PLAQUE ARE ITEMS ADDRESSED IN THE PRODUCT INSERT UNDER PRECAUTIONS.
UAC INFUSING AT 10 CC/HR. RN NOTED FLUID LEVEL IN BURETTE HAD NOT CHANGED IN 2 HRS. RN CLAMPED TUBING ABOVE TO ASSURE NO DOUBLE DRIPPING. BLOOD GLUCOSE WAS 75 PREVIOUSLY BUT DECREASED TO 48. RN ASSUMED PUMP NON-INFUSION.
EMERGENCY CORONARY ARTERY BYPASS GRAFT, STARTED BYPASS WITH THE HEATER/COOLER VALVE IN THE "OFF" POSITION. A FEW MINUTES LATER, OPENED THE VALVE ON THE HEATER/COOLELR TO BEGIN COOLING THE PT. THE PERFUSIONIST NOTICED A SHADOW IN THE WATER LINES AND TURNED THE VALVE OFF. THE PERFUSIONIST THEN FOCUSED ON THE WATER LINES AND REOPENED THE VALVE, AND CONFIRMED BLOOD IN THE WATER LINE. THE SURGEON WAS NOTIFIED AND THE OXYGENATOR WAS CHANGED OUT. ONE GRAM OF ANCEF (AN ANTIBIOTIC) WAS GIVEN AND THE CASE WAS COMPLETED WITHOUT INCIDENT. NO SIGNS OF HEMOLYSIS AND NO SIGNS OF PT COMPROMISE DURING THE REST OF THE PROCEDURE, TWO DAYS POST-OP THE PT WAS DOING FINE.
LEAK TESTING WAS DONE BY FILLING THE BLOOD SIDE OF THE OXYGENATOR WITH DI WATER AND ALLOWING IT TO SET AMBIENT FOR 10 MINUTES. THE OXYGENATOR WAS ROTATED SO THE WATER PORTS WERE POINTING DOWN AND THE FLUID IN THE UNIT WAS THEN PRESSURIZED TO 3 AND 10 PSI FOR 10 MINUTES EACH. THE WATER SIDE WAS LEAK TESTED BY ATTACHING HANSEN FITTINGS TO THE WATER PORTS AND FILLING THE HEAT EXCHANGER WITH WATER PRESSURIZED TO 10 PSI. NO LEAK WAS SEEN FROM BLOOD TO WATER SIDE AT AMBIENT OR 3 PSI TESTING, BUT AFTER 210 MINUTES AT 10 PSI, A SMALL AMOUNT OF WATER WAS SEEN DRIPPING FROM THE WATER OUTLET PORT; THE LEAD RATE WAS 12 ML/10 MIN. THE BLOOD SIDE WAS DRIED AND THE WATER SIDE WAS FILLED WITH FLUID AND PRESSURIZED TO 10 PSI. NO LEAK WAS SEEN AFTER 30 MINUTES. THE PRESSURE WAS LEFT ON OVER NIGHT AND AFTER A TOTAL OF APPROX 16 HOURS, 50 ML HAD BEEN COLLECTED FROM THE VENOUS BLOOD PORT. AN ADD'L TIMED COLLECTION PRODUCED A LEAK RATE OF <1 ML/10 MINUTES. THE HEAT EXCHANGER WAS REMOVED, AND THE BLOOD MANIFOLDS OF THE HEAT EXCHANGER WERE CAREFULLY MILLED OFF. THE WATER SIDE WAS THEN PRESSURIZED WITH AIR (APPROX 2 PSI), AND THE HEAT EXCHANGER WAS THEN SUBMERGED IN WATER. AIR BUBBLES WERE NOTED COMING UP BETWEEN APPROX THE 4TH AND 5TH AND THE 13TH AND 145TH FOLDS OF THE HEAT EXCHANGER BUNDLE. MICROSCOPIC EXAMINATION OF THE EXPOSED BUNDLE DID NOT REVEAL ANY SIGNS OF THE LEAK SITES. THE WATER MANIFOLDS WERE THEN MILLED OFF AND BY PRESSURIZING THE BLOOD SIDE (APPROX 1 PSI), AIR BUBBLES WERE AGAIN NOTED COMING UP BETWEEN THE SAME FOLDS AS BEFORE. MICROSCOPIC EXAMINATION AGAIN COULD NOT IDENTIFY THE EXACT LEAK SITES. NEXT, PORTIONS OF THE HOUSING WERE MILLED OFF TO EXPOSE THE ENTIRE BUNDLE, AND IN SO DOING, THE END NEAR THE LEAK SITES WAS REMOVED AND EVIDENCE OF CORROSION AT THE BRAZE JOINTS WAS NOTED. TESTING OF THE UNIT CONFIRMED A LEAK IN THE HEAT EXCHANGER AT TWO SITES, AND AUTOPSY OF THE ENDS OF THE HOUSING REVEALED EVIDENCE OF CORROSION AT THE BRAZE JOINT. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT ALL PRODUCTION LEAK TESTS WERE PASSED. THESE TESTS INVOLVED TESTING OF THE WATER SIDE OF THE HEAT EXCHANGER TWICE AND TESTING OF THE BLOOD SIDE OF THE HEAT EXCHANGER THREE TIMES WITH PRESSURIZED AIR UP TO 90 PSI. IT THUS APPEARS THAT THE LEAK PATHWAY WAS FORMED SOMETIME AFTER THE FINAL PRODUCTION LEAK TEST. SOME TYPES OF DISINFECTANTS COMMONLY USED IN THE HOSP FOR CLEANING OF HEATER/COOLER UNITS MAY CAUSE PITTING CORROSION IF NOT THOROUGHLY RINSED OUT PRIOR TO USE WITH THE HEAT EXCHANGER. CO OXYGENATOR INSTRUCTIONS FOR USE CONTAIN A WARNING THAT IF ADDITIVES OR DISINFECTANTS ARE USED IN THE HEATER/COOLER SYSTEM, THE WATER SYSTEM MUST BE THOROUGHLY RINSED PRIOR TO CONNECTION TO AN OXYGENATOR. ALTHOUGH IT IS NOT POSSIBLE TO STATE DEFINITIVELY THE CAUSE OF THE HEAT EXCHANGER LEAK; IT IS POSSSIBLE THAT IT WAS CAUSED BY DISINFECTANTS IN THE WATER THAT WERE CIRCULATED THROUGH THE HEAT EXCHANGER AT THE HOSP.
THE DEVICE LEAKED DURING ADMINISTRATION OF DOBUTAMINE AND AMRINONE.
CUSTOMER INDICATED THAT SAMPLES WOULD NOT BE RETURNED TO CO FOR EVAL. LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. FOLLOW UP WITH THE CUSTOMER INDICATES THAT THERE HAVE BEEN NO FURTHER ISSUES. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVAL. ADD'L REPORT WILL BE PROVIDED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF CO'S EVAL.
PT WITH AN NG TUBE WAS FOUND APPROX. 7 HRA POST OP HAVING HAD A LARGE EMESIS AROUND AN NG TUBE. PT HAVING DIFFICULTY BREATHING OBVIOUSLY HAVING ASPIRATED WHILE VOMITING. PT INTUBATED AND PLACED ON A VENTILATOR. PT DID NOT RESPOND TO THERAPY, LIFE SUPPORT WAS DISCONTINUED AFTER 48 HRS AND PT EXPIRED. UPON INVESTIGATION, IT WAS NOTED THAT THE FILTER FLOAT AT THE TOP OF THE SUCTION CANISTER WAS "STUCK" AND THEREFORE THERE WAS NO SUCTION TO THE PT WHICH APPARENTLY RESULTED IN THE PT'S VOMITING. (CANISTER HAD BEEN EMPTIED WHEN PT WENT TO SURGERY AND WAS RECONNECTED APPROX. 6 HRS LATER). SMEAR - MODERATE WBC, FEW EPITHELIAL CELLS MANY GRAM NEGATIVE BACILLI, FEW GRAM POSITIVE COCCI AND BACILLI. CULTURE - 4+ GROWTH PROBABLE PSEUDOMONAS 2+ GROWTH SECOND GRAM NEGATVIE BACILLUS IDENTIFICATION AND SENSITIVITIES TO FOLLOW. 12:30 AM THIS PORTABLE CHEST SHOWS 1. MILD PNEUMONIA IN BILATERAL LUNG BASES AS DESCRIBED. 2. ENDOTRACHEAL TUBE IN SATISFACTORY POSITION. 3. NO SIGNIFICANT CHANGE IN LEFT SUBCLAVIAN CATHETER. 6:30 AM MILD WORSENING OF PNEUMONIAS OF BILATERAL LOWER LUNG FIELDS. 10:50 AM PORTABLE CHEST SHOWS ASPIRATION PNEUMONIA IN BILATERAL LOWER LUNG FIELDS AS BEFORE. ENDOTRACHEAL TUBE IN SATISFACTORY POSITION.
PHLEBOTOMIST WAS EXPOSED TO BLOOD AFTER THE NECK OF THE BOTTLE SNAPPED OFF AS SHE WAS READY TO ENTER IT INTO THE INSTRUMENT. SHE WAS NOT WEARING GLOVES. SHE WAS NOT CUT BY THE BROKEN GLASS BUT HAS CRACKED SKIN AT CUTICLE. SHE WASHED HER HANDS AND APPLIED BLEACH IMMEDIATELY. PHLEBOTOMIST WAS TAKEN TO THE ER AND RECEIVED PROPHYLACTIC MEDICATION AND COUNSELING.
A 68-YR-OLD MALE WITH HX OF RENAL FAILURE, GI BLEED AND POST HEMICOLECTOMY WAS RECEIVING HYPERALIMENTATION. HE WAS BEING MEASURED FOR HIS BLOOD GLUCOSE WITH METER AS WELL AS BLOOD SAMPLES PROCESSED IN CENTRAL LAB. ON THE MORNING OF 10/4 BOTH LAB AND METER RESULTS WERE ALMOST THE SAME READINGS 86 + 96. DURING THE EVENING OF 10/4 METER SHOWED A READING OF 296, 5 IU OF REGULAR INSULIN GIVEN. ON 10/5 PT THEN STATUS CHANGED. LAB GLUCOSE SHOWED 28 AND METER SHOWED 196. METER CHECKED BY BIOMED AND WAS OK. INCIDENT REVIEW TEAM TEST: GLUCOSE STRIPS DEFECTIVE.
PT WITH AN N&G TUBE WAS FOUND APPROX 7 HRS POST-OP HAVING HAD A LARGE EMESIS AROUND THE NG TUBE, PT HAVING DIFFICULTY BREATHING OBVIOUSLY HAVING ASPIRATED WHILE VOMITING. PT INTUBATED AND PLACED ON VENTILATOR. PT DID NOT RESPOND TO THERAPY, LIFE SUPPORT WAS DISCONTINUED AFTER 48 HRS AND PT EXPIRED. UPON INVESTIGATION IT WAS NOTED THAT THE FILTER FLOAT AT THE TOP OF THE SUCTION CANNISTER WAS "STUCK" AND THEREFORE THERE WAS NO SUCTION TO THE PT WHICH APPARENTLY RESULTED IN THE PT VOMITING. (CANNISTER HAD BEEN EMPTIED WHEN PT WENT TO SURGERY AND WAS RE-CONNECTED APPROX. 6 HRS LATER.)
CYTOLOGIST WAS ATTEMPTING TO INOCULATE A 12B VIAL WITH A FINE NEEDLE ASPIRATE FROM A LIVER ABSCESS WHEN THE SYRINGE CAME APART FROM THE NEEDLE. THE VIAL CONTENTS WERE FORCED OUT THROUGH THE NEEDLE IN A JET WHICH SPRAYED INTO HER FACE AND EYES.
REFERENCE PIR NO 1-15491. THE CYTOLOGIST WAS NOT USING A LUER-LOK SYRINGE AND WAS NOT WORKING IN A "SAFETY CABINET." ALSO NOT USING PERSONAL PROTECTIVE EQUIPMENT AND DID NOT PRE-GAS THE VIAL PRIOR TO IN OCULATION AS INSTRUCTED.
PARTICULATE MATTER WAS FOUND IN THE CASSETTE UPON PRIMING.
THE CUSTOMER RETURNED ONE SAMPLE TO CO FOR EVAL. EXAMINATION OF THE UNIT SHOWED A PEICE OF BURNT PLASTIC PRESENT IN THE SET. PURCHASING HAS BEEN NOTICED TO FOLLOW UP WITH THE TUBING SUPPLIER. LOT HISTORIES WERE EVALUATED AND WERE FOUND TO BE ACCCEPTABLE. CO WAS ABLE TO CONFIRM THIS ISSUE AND TO DETERMINE THE CAUSE. BASED ON THIS INFO. CO BELIEVES THAT THIS ISSUE IS BEING ADDRESSED AND THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME.
REAR S/F DAB HEMI PNTD R O2 DEALER CLAIMS FRAME IS CRACKED.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE, DESIGNS, INC, OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE WRAP SENSOR HAS A PROTECTIVE SHEATH WHICH COVERS THE FIBEROPTIC WHICH IS A VERY THIN RUBBER. THESE SHEATHS ARE EASILY TORN. THE MOST VULNERABLE PART OF THE DEVICE HAS THE LEAST AMOUNT OF PROTECTION. THE END OF THE SENSOR WHERE THE FIBEROPTIC LIGHT ILLUMINATES IS ALSO EASILY TORN WITH DAILY USE. HOSP CLINICAL ENGINEERS HAVE EXAMINED THE DAMAGED SENSORS AND DEEMED THEM "UNREPAIRABLE" DUE TO MFR DEFECT. THE DEVICE IS WARRANTED FOR 90 DAYS. AFTER 90 DAYS IF THE DEVICE BECOMES DAMAGED YOU HAVE NO ALTERNATIVE BUT TO PURCHASE A NEW DEVICE. PRICE $1500.00. THIS DEVICE MUST BE USED IN THE MRI ENVIRONMENT TO ELIMINATE THE POSSIBILITY OF A "BURN" WHICH HAS OCCURRED WITH CONVENTIONAL PULSE OXIMETRY DEVICES AND SENSORS. THIS DEVICE SHOULD BE REDESIGNED TO INCREASE ITS LIFE EXPECTANCY AS WELL AS RELIABILITY. ONCE THE SHEATH OR SENSOR IS DAMAGED IT WILL FAIL. IT WILL NOT SENSE THE PULSE RATE OR 02 SATURATION. SENSOR WAS PLACED ON A PT, 10/8/96, AND IT FAILED. THE MONITOR READ "LOW LIGHT" SAME DAY CLINICAL ENGINEERS TESTED THE SENSOR WITH TWO (2) DIFFERENT MONITORS AND DEEMED THE SENSOR DAMAGED, NON-FUNCTIONAL.
A BALLOON RUPTURED AT APPROX. 5-8 ATMS DURING AN ERCP PROCEDUE. A PERFORATION OF THE COMMON BILE DUCT WAS NOTED FOLLOWING BALLOON RUPTURE. A STENT WAS PLACED AND THE PT HAS SINCE BEEN DISCHARGED IN GOOD CONDITION. THE DEVICE IS SURRENTLY BEING EVALUATED BY THIS MFR. UPON THE COMPLETION OF THE ENGINEERING EVALUATION, A SUPPLEMENTAL MEDWATCH WILL BE FORWARDED UNDER THE ABOVE NOTED SEQUENCE NUMBER. THE PT'S INITIAL DIAGNOSIS WAS ULCERATIVE SCLEROSIS WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR TO THIS EVENT. HOWEVER, UNTIL COMPLETION OF THE ENGINEERING EVALUATION, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT.
THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE DEVICE WAS IDENTIFIED AS CATALOG NUMBER 6766 WHICH IS A CORRECTION FROM CO'S INITIAL REPORT. A MINOR LEAK WAS EVIDENCED BETWEEN THE BALLOON AND THE SHAFT. ALTHOUGH A RARE OCCURRENCE, AN OPTIMIZATION OF THIS PHASE OF THE MFG PROCESS HAS BEEN IMPLEMENTED.
THE SET DID NOT DELIVER IV SOLUTION RESULTING IN THE PT'S GLUCOSE DROPPING.
THE CUSTOMER RETURNED TWO SAMPLES TO CO FOR EVAL. EXAMINATION OF THE RETURNED UNITS SHOWED THAT ONE UNIT WAS BLOCKED. THE BLOCKAGE WAS DUE TO EXCESS SOLVENT USED DURING THE ASSEMBLY PROCESS. PRODUCTION HAS BEEN NOTIFIED AND IS RETRAINING ASSOCIATES. THIS ISSUE WAS ALSO CONFIRMED IN HOUSE. CO WAS ABLE TO CONFIRM THIS ISSUE AND TO DETERMINE THE CAUSE. BASED ON THIS INFO CO BELIEVES THAT THIS ISSUE HAS BEEN ADDRESSED AND THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME.
ON 9/14, THE PT OBTAINED A FASTED MORNING METER READING ON HER TEST STRIPS, (EXP 3/98) OF 20 MG/DL. ALTHOUGH SHE WAS FEELING WELL, SHE DRANK ORANGE JUICE AND ATE TO RAISE HER BLOOD SUGAR LEVEL. ANOTHER METER READING AFTER EATING WAS 20 MG/DL. SHE AGAIN ATE AND DRANK MORE ORANGE JUICE FOLLOWED BY A READING OF 54 MG/DL. BASED UPON OF THE LOW READINGS, SHE DID NOT TAKE HER MORNING INSULIN, BUT WENT TO THE HOSP WHERE A SIDE-BY-SIDE METER TO METER COMPARISON WAS PERFORMED. THE PT'S METER READ 51 MG/DL WHILE THE HOSP METER (BRAND UNK) READ 440 MG/DL. SHE WAS TREATED WITH INSULIN AND RELEASED. ALTHOUGH THE METER IS CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, IT IS NOT CLEANED ONCE A WEEK AS SUGGESTED IN THE OWNER'S MANUAL. THE METER WAS IN CALIBRATION ON 9/14, READING 72 VERSUS A RANGE OF 64-87, HOWEVER, A CONTROL SOLUTION TEST PERFORMED ON THE SAME DAY READ 11, OUTSIDE OF THE LABELED  RANGE OF 77-109.
H6 RESULT:  NO NON-CONFORMANCES.  CO IS UNABLE TO COMPLETE THEIR INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE DUE TO THE FACT THAT THE METER WAS NOT RETURNED TO LIFESCAN.  THEREFORE, CO HAS NOT BEEN ABLE TO EVALUATE THE METER TO DETERMINE WHETHER OR NOT A DEVICE MALFUNCTION MAY HAVE CONTRIBUTED TO THIS EVENT.  BATCH RECORD REVIEW INDICATES NO NON-CONFORMANCES IN THE MANUFACTURING PROCESS.  AT THIS POINT, CO CONSIDERS THIS MATTER CLOSED.  H6= BATCH RECORD REVIEW.
THE DEVICE WAS REMOVED AS IT "DOES NOT DEFLATE".
GRAFT WAS IMPLANTED AS AN AORTO-BIFEMORAL BYPASS GRAFT. THE DR CLAIMS THAT IT LEAKED BLOOD FROM THE CROTCH (QUANTITY UNKNOWN). THE BLEEDING WAS STOPPED WITH A HEMOSTATIC AGENT AND THE GRAFT WAS LEFT IN. THE PT'S CONDITION IS OK.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" HAVE NO INFO AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT.
IT WAS STATED (SECTION F-9) THAT THE APPROXIMATE AGE OF THE DEVICE IS 5 YEARS OLD. CO'S RECORDS INDICATE THROUGH VERIFICATION OF THE IMPLANT REGISTRATION, THAT THE PATIENT WAS ORIGINALLY IMPLANTED ON 10/9/84. OUR RECORDS INDICATE THE APPROXIMATE AGE OF THE DEVICE IS 12 YEARS OLD. TWO CYLINDERS, A PUMP, A RESERVOIR, AND TWO CONNECTORS WERE RECEIVED AND EVALUATED BY THE MFR. PORTIONS OF TUBING TEARS WERE IDENTIFIED WITH THE RETURNED COMPONENTS. THE PUMP INLET TUBING, THE PUMP OUTLET #2 TUBING, THE TUBING ATTACHED TO THE OUTLET CONNECTOR, AND THE TUBING ATTACHED TO THE INLET CONNECTOR SHOWED CROSS SECTIONAL SURFACES THAT WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. ABRASION WAS LOCATED ON BOTH SIDES OF THE INLET TUBING ATTACHED TO THE CONNECTOR. THIS TUBING WAS RECEIVED BENT TOWARD AN OBVIOUS SEPARATION/LEAKAGE SITE, INDICATING THAT WHILE IN-VIVO THIS TUBING WAS BENT IN A SIMILAR MANNER. PRESSURE CHALLENGES TO THE PUMP VALVE REVEALED NO FUNCTIONAL ABNORMALITIES. BASED ON QUALITY ASSURANCE'S EXAMINATION AND TESTING, QA WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED INABILITY TO DEFLATE. HOWEVER, QA CONCLUDES THAT FOUR AREAS OF THE RECEIVED COMPONENTS WERE TORN. TWO OF THESE TEARS (THE OUTLET CONNECTOR TUBING, AND INLET CONNECTOR TUBING) RESULTED IN OBSERVABLE LEAKS. THE OTHER TWO TEARS, LOCATED AT THE PUMP INLET TUBING AND PUMP OUTLET #2 TUBING, WOULD HAVE RESULTED IN LEAKS, IF THEY EXISTED WHILE IN-VIVO. QA'S FINDINGS OF LEAKAGE ARE CONTRADICTORY TO THE RECEIVED COMPLAINT THAT MENTIONED AN INABILITY TO DEFLATE THE DEVICE. THEREFORE, QA CONCLUDES THAT THE OBSERVED TEARS MAY HAVE OCCURRED DURING OR SUBSEQUENT TO REMOVAL OF THE PROSTHESIS.
THE DEVICE DISCONNECTED DURING USE ALLOWING A SMALL LOSS OF BLOOD. NO TRANSFUSION WAS REQUIRED. THE REPORTER INDICATED THAT THIS HAD OCCURRED ON SIX OCCASIONS BUT DID NOT PROVIDE SPECIFIC DETAILS.
THE CUSTOMER RETURNED ONE SAMPLE ALONG WITH A SAMPLE OF ANOTHER MFR'S CATHETER TO CO FOR EVAL. EXAMINATION OF THE RETURNED UNIT SHOWED THAT THE MALE LUER CONFORMED TO ANSI STANDARDS. THE FEMALE ON THE OTHER MFR'S CATHETER WAS SLIGHTLY UNDERSIZED. BOTH FIT SNUGGLY TOGETHER. TESTING WAS UNABLE TO DUPLICATE THIS ISSUE. LOT HISTORIES WERE REVIEWED AND WERE FOUND TO BE ACCEPTABLE. CO WAS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE. BASED ON THIS INFO. CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME.
THE GRAFT LEAKED AT THE CROTCH AND AT A POINT ON THE ILIAC (QUANTITY UNKNOWN). THE DR ATTEMPTED TO REPAIR THE LEAKS WITH SUTURES, BUT WAS CLAIMED THAT HE WAS UNABLE TO STOP THE LEAKS AND ULTIMATELY DECIDED TO REPLACE THE COMPLAINT GRAFT WITH ANOTHER GRAFT. THE CONDITION OF THE PT IS FINE.
RETURNED SEGMENTS OF THE EXPLANTED GRAFT WERE EVALUATED BY CO'S CONSULTING PATHOLOGIST. A COPY OF THAT REPORT IS ATTACHED. RECEIVED IN FIXATIVE ARE THREE SEGMENTS OF AN AORTIC-BIFEMORAL VASCULAR GRAFT. THE AORTIC SEGMENT MEASURES 5.8 CM IN LENGTH BY 2.0 CM IN DIAMETER. THE ILIAC SEGMENTS ARE SIMILAR IN LENGTH AND MEASURE UP TO 21 CM IN LENGTH BY 1.2 CM IN DIAMETER. NO FIBROUS TISSUE IS ATTACHED TO THE OUTER SURFACE. THE PRESENCE OF BLOOD IS IDENTIFIED ON THE OUTER AND INNER SURFACES. REP SECTIONS ARE EMBEDDED UNDER MD-921, MD-922 AND MD-923. A COLLAGEN-COATED AORTO-BIFEMORAL VASCULAR GRAFT IS IDENTIFIED. ALL SECTIONS, AORTIC AND FEMORAL, ARE SIMILAR IN HISTOLOGICAL APPEARANCE. NO LOSS OF INTEGRITY OF THE FABRIC IS IDENTIFIED. NO LOSS OF INTEGRITY OF THE COLLAGEN COATING IS IDENTIFIED. COLLAGEN COATING IS PRESENT ON THE LUMINAL SURFACE, ADVENTITIAL SURFACE AND WITHIN THE INTERSTICES OF THE VASCULAR GRAFT. BLOOD ELEMENTS ARE PRESENT ON THE LUMINAL AND ADVENTITIAL SURFACES AS WELL AS FOCALLY WITHIN THE INTERSTICES OF THE VASCULAR GRAFT. AN INTACT COLLAGEN-COATING AORTO-BIFEMORAL VASCULAR GRAFT IS IDENTIFIED WITH AN INTACT COLLAGEN COATING AND INTACT FABRIC. NO LOSS OF INTEGRITY OF THE COLLAGEN COATING OR IS IDENTIFIED. BLOOD ELEMENTS ARE IDENTIFIED ON THE SURFACES AND WITHIN THE INTERSTICES OF THE VASCULAR GRAFT.
PT SUSTAINED BURN DURING OPHTHALMOLIC PROCEDURE.
AN ACTIVE ELECTROSURGICAL ELECTRODE (NOT MFG BY CO) WAS INSERTED INTO THE CO'S ELECTROSURGICAL INSTRUMENT. A "RUBBER SHOD" (A PIECE OF CUT CATHETER TUBING) WAS INSERTED OVER THE ELECTRODE THEREBY MODIFYING CO'S DEVICE. THE BLADE AND "RUBBER SHOD" WERE NOT RETURNED. DR HAS STATED THAT HE NOTICED NO IRREGULARITIES WITH THE ELECTROSURGUICAL INSTRUMENT DURING THE PROCEDURE. HE IS BAFFLED OVER THE EVENT. HE IS NOT SURE HOW IT OCCURRED. NO ADD'L INFO WILL BE PROVIDED BY THE HOSP AT THIS TIME. EVALUATION SUMMARY: ON 10/14/96, THE PENCIL WAS TESTED FOR PERFORMANCE IN THE CUT AND COAG MODES AND FOUND TO PERFORM AS INTENDED. NO EVIDENCE OF DEFECT NOTED.
THE DEVICE WAS REMOVED DUE TO "EROSION". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A CO'S 3-PIECE INFLATABLE PENILE PROSTHESIS.
EVALUATION OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF EROSION. THEREFORE, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF THIS AS THE CAUSE FOR REMOVAL. WITHOUT THE BENEFIT OF EXAM AND TESTING, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE. IN ADDITION, WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM CONFIRMING THAT THE REFERENCED PRODUCT WAS MFG BY THIS MFR AND IS PRECLUDED FROM DETERMINING WHAT CIRCUMSTANCES MAY HAVE CONTRIBUTED TO THIS OCCURRENCE.
DURING INSERTION OF THE CATHETER, THE M.D EXPERIENCED DIFFICULTY IN PLACING THE CATHETER. HE HELD THE CATHETER IN PLACE AND REMOVED THE STYLET. THEN THE STYLET WAS RE-INSERTED AND SOME RESISTANCE WAS FELT. THE CATHETER WAS REMOVED AND IT WAS DISCOVERED THE STYLET TIP HAD EXITED THE CATHETER SIDE HOLES DURING RE-INSERTION OF THE STYLET. THE UNIT WAS REPLACED WITH NO ADVERSE IMPACT TO THE PT. THE INSTRUCTIONS FOR USE PROVIDED IN EACH CARTON OF CATHETERS CAUTIONS UNDER ITEM #6: WARNING: TO AVOID PERFORATION OF THE HEART WALL, USE STYLET ONLY TO FACILITATE INITIAL PENETRATION.
MEDICAL EXAMINER REPORTS A PT DEVELOPED RESPIRATORY DISTRESS AND BRAIN INJURY FOLLOWING THE ADMINISTRATION OF AZMACORT WITH AN APPARATUS OTHER THAN THAT PROVIDED BY THE MFR. PT BECAME COMATOSE AND DIED. FURTHER INFO IS EXPECTED.
THIS EVENT WAS REPORTED AS SYSTOLIC ANTERIOR MOTION AND REGURGITATION. NO FURTHER INFO PROVIDED.
THE DEVICE WAS REMOVED DUE TO "EXTRUSION". AS REPORTED TO CO, THAT ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CO'S 2-PIECE INFLATABLE PENILE PROSTHESIS.
THE LIMITED INFO RECEIVED INDICATES NO APPARENT MALFUNCTION OF THE DEVICE AND INDICATES THE DEVICE WAS REMOVED TO ADDRESS EROSION OF THE CYLINDER THROUGH THE CORPORA. EXAM AND TESTING OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR SUPPORT THE OCCURRENCE OF EROSION AND QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS AS THIS FOR THE CAUSE OF SURGICAL INTERVENTION. THE OPERATIVE NOTES RECEIVED INDICATES THE DEVICE WAS RETURNED TO THE MFR. HOWEVER, AT THIS TIME THE PRODUCT HAS NOT BEEN RECEIVED. QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE EROSION BUT ACKNOWLEDGES THAT THE PT'S HISTORY OF INSULIN DEPENDENT DIABETES MAY HAVE CONTRIBUTED TO THIS OCCURRENCE.
PT BEGAN A CONTINUOUS INFUSION OF 5-FU OF 545 MG/DAY ON 3/14/95. THE PT'S 2ND WEEK OF THERAPY BEGAN ON 3/21/95. AT THAT TIME, 7 DAYS WORTH OF MEDICATION WAS INFUSED IN LESS THAN 24 HRS. THE PT WAS HOSPITALIZED. 3/29/95 PT DEVELOPED PANCYTOPENIA, 4/7/95 NOT RESOLVED. THE PUMP WAS RETRIEVED AND SENT TO LOCAL PUMP VENDOR FOR TESTING. PUMP MET MFR PRESCRIBED PERFORMANCE STANDARDS. LOCAL VENDOR THEN SENT THE PUMP TO THE MFR FOR FURTHER TESTING.
QR AXLE WITH SPACER. DEALER CLAIMS QR AXLE FELL APART.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF LOSS OF SENSING/CAPTURE.
THE DEVICE WAS REMOVED DUE TO A "LEAK". AS REPORTED TO CO BY THE MFR'S FIELD REPRESENTATIVE, THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED AS THE "URETHRA WAS INADVERTENTLY PUNCTURED DURING THE PROCDURE".
THIS INFLATABLE PENILE PROTHESIS WAS IMPLANTED ON 3/4393 AND REMOVED ON 10/14/96 DUE TO A "LEAK." A RESIPUMP, TWO CYLINDERS AND REAR TIP EXTENDERS WERE RETURNED TO THE MFR FOR EVAL. IN THE RECEIVED INFO THE MD STATED THAT LEAKAGE WAS OBSERVED "IN THE CONNECTING TUBING TO RESIPUMP." THE MD STATED THAT NO KINKING OR TWISTING OF THE TUBINGS WAS OBSERVED, THE DEVICE WAS NO IN A POSITION THAT WOULD HAVE CAUSED STRESS(S) AND THAT NEITHER AN INADEQUATE NOR AN EXCESSIVE AMOUNT OF TUBING WAS OBSERVED. THE MD FURTHER STATED THAT THERE WAS NO INFO IN THE PT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE AND THAT THE DEVICE WAS NOT IN CONTACT WITH SHARP INSTRUMENTATION DURING OR SUBSEQUENT TO EXPLANT. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A SEPARATION/LEAKAGE SITE IN OUTLET #1'S EXITING TUBE AT THE STRAIN RELIEF/TUBE JUNCTION. EXAMINATION OF THE SURFACES OF THE SEPARATION REVEALED MARKINGS CHARACTERISTIC OF STRESS(S) INDUCED RENDING. AN AREA OF ABRASION IS NOTED SURROUNDING AND PENETRATING THE SEPARATION. WITHIN THE AREA OF ABRASION A CREASE MARK IS OBSERVED. BASED ON QA'S EXAMINATION AND THE MD'S OBSERVATIONS, QA CONCLUDED THAT WHILE INVIVO OUTLET #1'S EXITING TUBE WAS PARTIALLY KINKED AND ABRADING AGAINST ITSELF AND ITS ASSOCIATED STRAIN RELIEF. QA FURTHER CONCLUDED ATHAT THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBING AT THIS SITE, ALLOWING THE NOTED LEAKAGE AND RENDERING THE DEVICE INOPERABLE.
THIS EVENT WAS REPORTED AS: "DEGENERATION." NO FURTHER INFO PROVIDED.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1986. PT ALSO ALLEGES SHE HAS A RUPTURE, THEY'RE LEAKING AND SHE'S SCARED.
LUMEN SIZE INADEQUATE FOR FIBEROPTIC CONFIRMATION OF PLACEMENT. LUMEN SIZE INADEQUATE FOR SUCTIONING WITH 14 FR SUCTION CATHETER. FREQUENT DISCONNECTION AT LUMEN CONNECTOR HUB WHEN TUBE WARMS AND SOFTENS. METAL CONNECTOR HUB AT Y-CONNECTOR JAMS IN ANESTHESIA CIRCUIT. OVERALL, RPTR FEELS DOUBLE LUMEN TUBE IS OF SUB-STANDARD DESIGN.
X-TUBE, ASSEMBLY 16" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CROSS BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
LUMEN SIZE INADEQUATE FOR FIBEROPTIC CONFIRMATION OF PLACEMENT. (STANDARD CARE). LUMEN SIZE INADEQUATE FOR SUCTIONING WITH A 14 FR SUCTION CATHETER. FREQUENT DISCONNECTION AT LUMEN CONNECTOR HUB WHEN TUBE WARMS AND SOFTENS. METAL CONNECTOR HUB AT Y-CONNECTOR JAMS IN ANAETHESIA CIRCUIT. OVERALL, RPTR FEELS DOUBLE LUMEN TUBE IS OF SUB-STANDARD DESIGN.
PT RECEIVED A PENILE IMPLANT ON AN UNK DATE AND OF AN UNK MFR. PT ALLEGES THE IMPLANT WAS DEFECTIVE WHICH CAUSED A HOSP STAY AND EXTENSIVE RECOVERY; HOWEVER, NO SPECIFIC INJURIES WERE PROVIDED.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. A PORTION OF THE LEAD REMAINS IMPLANTED.
A 44-YR-OLD MALE WHO HAD PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) 1/95 TO RIGHT CORONARY ARTERY (RCA) AFTER ACUTE MYOCARDIAL INFARCTION (MI); HAD STENT TO RCA FOR RESTENOSIS. PRESENTED AGAIN 9/96 WITH RECURRENT ANGINA. FOUND TO HAVE WITHIN-STENT RESTENOSE. TREATED SUCCESSFULLY WITH ATHERECTOMY DEVICE AND PTCA.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS X-TUBE BROKE ON THE LEFT SIDE AT THE PIVOT POINT.
THIS REPORT WAS REPORTED AS: REGURGITATION. NO FURTHER INFO PROVIDED.
PT ALLEGES RECEIVING BREAST IMPLANTS IN APRIL, 1990. PT ALSO ALLEGES SHE IS HAVING PROBLEMS WITH HER BREAST IMPLANTS. SHE HAS SOME KIND OF INFECTION, HER BREAST IMPLANTS MIGHT BE LEAKING CAUSING INFECTION, SHE IS TAKING ANTIBIOTICS, SHE MIGHT NEED REMOVAL, PUS IS COMING FROM OUT OF HER BODY, SHE HAS BEEN SICK AND WANTS TO GET THEM REMOVED.
THE LEAD WAS EXPLANTED DUE TO REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. FAILURE ANALYSIS IS PROVIDED.
THIS ENTIRE FORM COMPLETED BY MFR. EVAL SUMMARY. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED 44MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 44MM AND HAS MIGRATED DOWN LEAD BODY 57 MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE LENGTH OF THE J STIFFENER WIRE WAS RECEIVED WITH RECORDED MEASUREMENTS ADDING UP TO 88MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURE.
THE DEVICE WAS REMOVED DUE TO A "LEAK AT THE CONNECTOR CYLINDER TO PUMP." THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 3-PIECE INFLATABLE PENILE PROSTHESIS. ADED'L SER NO: 025808.
ACCORDING TO THE AVAILABLE INFORMATION, THIS PENILE PROSTHESIS WAS IMPLANTED ON 5/3/85. ON 9/13/96 THE DEVICE WAS REMOVED DUE TO A REPORTED "LEAK AT CONNECTOR." THE RECEIVED OPERATIVE NOTES STATED THAT, "A LEAK WAS FOUND AT THE CONNECTOR FROM THE RIGHT PENILE CYLINDER TO THE PUMP." DURING EXPLANT SURGERY THE PHYSICIAN CYCLED THE DEVICE TO FIND THE LEAK. THE PHYSICIAN DID NOT MENTION ANY DIFFICULTY WITH THE PUMP'S FUNCTION. ADDITIONALLY, THE OPERATIVE NOTES STATED, "THE PATIENT HAD A PREVIOUS IMPLANTATION OF AN INFLATABLE PROSTHESIS IN 1985 WHICH HAD FUNCTIONED WELL UNTIL APPROXIMATELY EIGHT MONTHS PRIOR TO THIS PROCEDURE WHEN THERE WAS A FLUID LOSS." THE ENTIRE DEVICE, INCLUDING THE TWO CYLINDERS, THE PUMP, AND THE RESERVOIR, WAS RECEIVED AND EVALUATED BY THE MFR. DURING FUNCTIONAL TESTING A LEAK WAS OBSERVED IN THE TUBING NEAR A CONNECTOR ATTACHED TO THE CYLINDER TUBING. TESTING REVEALED THE PUMP COULD NOT ATTAIN SUFFICIENT PRESSURE TO COMPLETE TESTING. EXAMINATION REVEALED  THAT A PUMP COULD NOT ATTAIN SUFFICIENT PRESSURE TO COMPLETE TESTING. EXAMINATION REVEALED THAT A PUMP BALL WAS LOCATED IN THE PUMP BULB. THE PUMP BALL WAS REPOSITIONED AND RE-TESTED. WITH THE BALL CORRECTLY POSITIONED, THE PUMP PASSED ALL FUNCTIONAL TESTS. A MICROSCOPIC EXAMINATION OF THE LEAKAGE SITE WAS PERFORMED. A CROSS SECTIONAL SURFACES OF THE LEAKAGE SITE WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. WITH THE BALL CORRECTLY POSITIONED, THE PUMP PASSED ALL FUNCTIONAL TESTS. A MICROSCOPIC EXAMINATION OF THE LEAKAGE SITE WAS PERFORMED. THE CROSS SECTIONAL SURFACES OF THE LEAKAGE SITE NEAR THE CONNECTOR WAS THE CAUSE OF THE REPORTED FLUID LOSS. THE LEAK WAS CAUSED BY STRESS(ES) EXPERIENCED BY THE DEVICE WHILE IN-VIVO. BASED ON THE OPERATIVE REPORT, QA CONCLUDES THAT THE PUMP BALL EXTRUDED DURING OR SUBSEQUENT TO EXPLANT SURGERY AND THEREFORE IS NOT RELATED TO THE RECEIVED COMPLAINT. HAD THE EXTRUDED PUMP BALL BEEN PRESENT IN-VIVO, ONLY ONE CYLINDER WOULD FULLY INFLATE. HAD THIS CONDITION BEEN PRESENT, THE PHYSICIAN MOST LIKELY WOULD MENTION THIS CONDITION IN THE OPERATIVE REPORT.
EXPERIENCE LOW PRESSURE ALARMS AND AUGMENTATION WAS POOR. THE IAB WAS REMOVED. PT EXPIRED THE NEXT DAY DUE TO ILNESS AND WAS NOT RELATED TO THIS INCIDENT.
H-11 ALL UNK INFO REQUESTED BUT NOT RECEIVED. H-11 SECTION F PROVIDED BY MFR. INTERNAL #061996090026
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO TEH REPORTABLE EVENT.
PT ALLEGES RECEIVING ONE IMPLANT IN JUNE, 1981 AND ONE IMPLANT IN 1982. PT ALSO ALLEGES HAVING CAPSULAR CONTRACTURE.
H3: AVAILABILITY OF DEVICE UNK AT THIS TIME. CONCLUSION: 68A OTHER (NO DEVICE RETURNED).
THE LEAD WAS EXPLANTED DUE TO A REPORT OF NON SPECIFIC FAILURE. FAILURE ANALYSIS IS PROVIDED.
THIS ENTIRE FORM COMPLETED BY MFR. EVAL SUMMARY. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED AT WELD SITE AND 30MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 58MM AND WAS REC'D WITH 10MM OF THE DISTAL END PROTRUDING OUT OF THE OUTER POLYURETHANE INSULATION 32MM PROXIMAL OF WELD SITE. 3MM OF THE PROXIMAL END OF THE J STIFFENER WIRE WAS REC'D WITH ALL RECORDED MEASUREMENTS ADDING UP TO 88MM. VISUAL INSPECTION UNDER 30X MAGNIFICTON ALSO INDICATES THE LEAD WAS SNIPPED OR CUT 28CM PROXIMAL OF ANODE BAND, WITH EVIDENCE OF FLARED COIL WIRE ENDS. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE OUTER ANODE COIL APPEARS TO HAVE FRACTURED 14CM PROXIMAL OF ANODE BAND. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURES.
DURING AN INVESTIGATION INTO A SUBSEQUENT EVENT, A PREVIOUSLY UNREPORTED EVENT WAS DISCOVERED. PER THE INFO PROVIDED TO CO BY PHYSICIAN BY MEANS OF AN OPERATIVE NOTE, "THE PT REPORTED THAT DURING INTERCOURSE, THE PROSTHESIS SUDDENLY DEFLATED. X-RAYS DID NOT REVEAL THE SOURCE OF THE LEAK". DURING THE SURGERY, THE PHYSICIAN/SURGEON REPORTED... "THE CONNECTION BETWEEN THE LEFT CYLINDER AND THE PUMP WAS DISCONNECTED, AND THIS WAS THE SOURCE OF THE LEAK. ALL CONNECTIONS WERE CUT OUT AND THEN REDONE".
A REQUEST WAS MADE TO THE HOSP FOR THE RETURN OF THE DEVICE COMPONENT. QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED CONNECTORS FOR EVALUATION, SINCE THEY WERE DESTROYED BY THE HOSP. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANTED COMPONENTS. QA IS PRECLUDED FROM CONFIRMING THE PHYSICIAN'S OBSERVATIONS AND PRECLUDED FROM COMMENTEING ON THE CONDITION OF THE DEVICE.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1978 OF AN UNK MFR. PT ALSO ALLEGES HAVING REMOVAL OF HER IMPLANTS IN 1992 BECAUSE SHE HAD A RUPTURE AND HAD SILICONE IN HER CHEST. PT DOESN'T BELIEVE SHE HAS ANY HEALTH PROBLEMS BECAUSE OF THIS AND FEELS SHE IS VERY HEALTHY.
MD FEELS THAT THE TESTING DEVICE IS NOT ACCURATE IN THE READINGS IT GIVES SINCE IT TAKES TOO LONG FOR THE URINE BEING TESTED TO GO THROUGH THE FILTERING SYSTEM. THE LABELING OF THE DEVICE DOES NOT SPECIFY THAT THIS COULD OCCUR IF IT TAKES LONGER TO FILTER THE SPECIMEN. ACCORDING TO THE INSTRUCTIONS, IT SHOULD TAKE 10 TO 15 SECS FOR THE MIXTURE TO PASS COMPLETELY THROUGH THE FILTER. IN MD'S EXPERIENCE, THE MIXTURE HAS NEVER COMPLETELY PASSED THROUGH THE FILTER IN 10 TO 15 SECS. THE MIXTURE HAS NEVER PASSED THROUGH THE FILTER IN LESS THAN 60 SECS AND USUALLY TOOK A NUMBER OF MINS. AT SOME POINT, MD CONTACTED MFR ABOUT THIS ISSUE, WHO SUGGESTED A NUMBER OF TECHNIQUES NOT CONTAINED IN THE PRODUCT DIRECTIONS TO HELP DECREASE THE AMOUNT OF TIME IT WAS TAKING FOR THE MIXTURE TO DRAIN.  NONE OF THE MFR'S SUGGESTIONS RESULTED IN ANY DECREASE IN FILTRATION TIME. AFTER A NUMBER OF DISCUSSIONS AND AFTER PRESSING THE MFR ON THE ISSUE, THEY CONCEDED THAT TIME WAS CRITICAL TO THE ACCURACY OF THE PRODUCT AND THAT IF THE MIXTURE DID NOT COMPLETELY PASS THROUGH THE FILTER IN 10-15 SECS, THE TEST RESULTS WOULD NOT BE ACCURATE. THE FIRST COMPLAINT BY THE CONSUMER IS THAT THE PRODUCT DOES NOT WORK AS ADVERTISED. SECOND, THE PRODUCT INSTRUCTIONS ARE INADEQUATE. NOWHERE IN THE INSTRUCTIONS DOES THE MFR DISCLOSE THAT ACCURACY CANNOT BE OBTAINED IF THE MIXTURE DOES NOT DRAIN IN THE 10-15 SEC TIME PERIOD. BASED UPON MD'S EXPERIENCE, THE PRODUCT IS DEFECTIVE, EITHER BECAUSE OF A DESIGN DEFECT, INADEQUATE INSTRUCTIONS, OR BOTH.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERTS.
THIS IS THE SAME PT/EVENT AS MFR #2219689-1996-00145. SECTION F1-14 HAS BEEN COMPLETED BY MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVALUATION: AS RECEIVED, BOTH TIBIAL INSERTS EXHIBIT MODERATE WEAR ON THEIR CONDYLAR SURFACES. THE LEFT KNEE INSERT DISPLAYS A WEAR PATTERN INDICATING A SIGNIFICANT INTERNAL MALROTATION. THE RIGHT KNEE INSERT SHOWS A MORE SYMMETRICAL WEAR PATTERN WITH AN APPROX 5 DEGREE MAL-ROTATION. THE LOT CODES SUPPLIED WERE FOR THE BASEPLATES AND NOT THE TIBIAL COMPONENTS, SO THAT A REVIEW OF THESE DEVICE HISTORY RECORDS IS NOT POSSIBLE. THE LOT CODE FOR THE RIGHT KNEE INSERT WAS AVAILABLE FROM THE PART AND A REVIEW OF ITS DEVICE HISTORY RECORD FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MFR. THE INFO PROVIDED AND THE EXAMINATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALIGNMENT. HOWEVER, THE OBSERVED WEAR ON EITHER INSERT IS NOT NECESSARILY UNUSUAL FOR THE REPORTED PERIOR OF IMPLANTATION. FILE #**840-19-96-09-06-B.
X-TUBE ASSEMBLY 18" X 17". DEALER CLAIMS X-TUBE BROKE AT PIVOT POINT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
LENS WAS REPLACED DUE TO DISLOCATION/BROKEN HAPTIC.
NO ADD'L INFO HAS BEEN REC'D DESPITE REQUEST. AS OF 10/11/96 THE LENS HAD NOT BEEN RETURNED TO THE MFR. THE MFR'S INTERNAL REFERENCE NUMBER IS 96L5059. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED = 1.
WHITE PAPER OVERWRAP ON IMPLANT HAD ADHERED TO DRUG IMPLANT WHEN OPENED. APPEARED TO BE LEAKAGE ON PAPER AND FROM IMPLANT WHEN VIEWED UNDER MICROSCOPE BY PHYSICIAN/SURGEON. RETURNED THE INVOLVED PRODUCT TO THE MFR.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT CTR PIVOT HOLE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OR INFO, DOES ONT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REPORTER STATED, THE PT FELL AND SUBSEQUENTLY EXPERIENCED PERSISTENT PAIN. REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA. BOTH DEVICES WERE REMOVED AND REPLACED.
SUMMARY OF EVAL: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED INSERT AND PATELLA WEAR AND PATELLAR COMPONENT DISASSOCIATION AS THEY HAVE NOT BEEN RETURNED TO CO. THE LOT CODES HAVE NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL. INFO PROVIDED STATED THAT THE PT HAD FALLEN ON HER IMPLANT.
PAIN SVC STAFF REPORTS TWO RELATED ISSUES THAT AFFECT PT SAFETY WITH THE INFUSION PUMP. THE FIRST ISSUE IS THAT THE FOUR-HR VOLUME LIMIT CAN BE EXCEEDED BY ROUTINE PCA BOLUS DOSING. IF A PT IS TO RECEIVE AN 8 ML/HR INFUSION AND IS PROGRAMMED TO RECEIVE 12 ML BOLUSES, WITH A 20 MIN LOCK-OUT INTERVAL USING THE PCA FUNCTION, IT IS POSSIBLE TO THAT PERSON TO EXCEED A 40 ML FOUR-HOUR VOLUME LIMIT. THIS IS CAUSED BY THE PUMP EXAMINING ITS FOUR-HOUR LIMIT, ONLY AT THE BEGINNING AND END OF AN BOLUS DOSE, AND NOT DURING ITS INFUSION. THIS CAN POTENTIALLY COMPROMISE THE SAFETY OF THE PT, BY ALLOWING AN OVERDOSE OF DRUG. IN ADDITION, IT IS POSSIBLE TO PROGRAM LARGE BOLUS DOSES OF DRUG. RPTR SUGGESTS TWO SOFTWARE CORRECTIONS TO ELIMINATE THESE PROBLEMS.
THE DEVICE WAS REMOVED AS THE DEVICE "PERFORATED THE URETHRA". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED.
SURGICAL REPORTS RECEIVED INDICATE THE DEVICE WAS REMOVED TO ADDRESS PAIN AND SWELLING IN THE SCROTUM. NO FUNCTIONAL ABNORMALITIES WERE NOTED. CYTOSCOPIC EXAM REVEALED AN AREA OF EROSION AND THE DECISION WAS MADE TO REMOVE THE ENTIRE DEVICE AND INSERT A FOLEY CATHETER. THERE IS NO NOTATION THAT THE DEVICE WAS REPLACED. BASED ON THE INFO RECEIVED AND BECAUSE EXAM AND TESTING OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT EROSION, QA ACCEPTS THE PHYSICIAN'S DIAGNOSIS OF THIS AS THE CAUSE FOR SURGICAL INTERVENTION. HOWEVER, AT THIS TIME THE REMOVED DEVICE HAS NOT BEEN RECEIVED, AND QA IS PRECLUDED FROM COMMENTING ON ITS CONDITION. HOWEVER, BASED ON THE INFO PROVIDED, QA CONCLUDES THE PT HISTORY OF DIABETES MAY HAVE CONTRIBUTED TO THIS OCCURRENCE.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
THE DEVICE WAS REMOVED DUE TO A "FLUID LOSS". "NO OBSERVABLE FAILURE POINT." AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CO'S 2-PIECE INFLATABLE PENILE PROSTHESIS. ADD'L SERIAL#: 012237. ADD'L LOT #: 012246
REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT, HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED FIVE SITES OF LEAKAGE. TWO OF THESE SITES, ONE ON EITHER SIDE OF THE CONNECTOR ATTACHED TO CYLINDER #2'S EXITING TUBING, ARE OBSERVED. EXAMINATION OF THE SITES REVEALED SEVERAL SMALL SEPARATIONS IN A LINEAR PATTERN. THE SURFACES OF THESE SEPARATION DISPLAY MARKINGS INDICATING CONTACT WITH SHARP OR UNSHOD INSTRUMENTATION, I.E. HEMOSTAT. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCDURES, QA CONCLUDED THAT THE OBSERVED DAMAGE WOULD HAVE RESULTED IN AN EARLIER DETECTED FLUID LOSS, QA CONCLUDED THAT THE DAMAGE MOST LIKELY OCCURRED AT OR SUBSEQUENST TO EXPLANT. THE THIRD SITE OF LEAKAGE IS ALSO OBSERVED IN CYLINDER #2'S EXITING TUBING. THIS SITE IS LOCATED IN THE TUBING AT THE DISTAL CONNECTION SITE. THE PLASTIC SHEATH HAS FALLEN OFF BUT THE TUBING IS STILL IN PLACE OVER THE METAL PORTION OF THE CONNECTOR. IN ADDITION IMPRESSION MARKINGS INDICATE THAT THE SHEATH WAS ONCE IN PLACE AT THIS SITE. EXAMINATION OF THE SITE REVEALED SEVERAL SMALL SEPARATIONS AROUND WHICH THE TUBING HAD A WORN APPEARANCE. THE FOURTH SITE OF LEAKAGE IS OBSERVED AT THE DISTAL CONNECTOR ATTACHED TO THE RESERVOIR'S INLET TUBING. THE LEAKAGE IS EMANATING FROM BENEATH THE CONNECTOR. THE FIFTH LEAKAGE SITE IS A SEPARATION IN OUTLET #2'S EXITING TUBING AT THE STRAIN RELIEF/TUBE JUNCTION. EXAMINATION OF THE SEPARATION REVEALED MARKINGS CHARACTERISTIC OF STRESS(S) INDUCED RENDING. FURTHER EXAMINATION REVEALED AN AREA OF ABRASION SURROUNDING AND PENETRATING THE SEPARATION. IN ADDITION, ADJACENT TO THE AREA OF ABRASION, A CREASE MARK IS NOTED. BASED ON QA'S OBSERVATIONS, QA CONCLUDED THAT WHILE IN-VIVO THE DISTAL CONNECTORS ON CYLINDER #2'S EXITING TUBING AND THE RESERVOIR'S INLET TUBING, ABRADED AND FATIGUED THE UNDERLYING TUBING AND THAT THIS, COMBINED WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBING AT THESE SITES. QA FURTHER CONCLUDED THAT WHILE INVIVO OUTLET #2'S EXITING TUBE WAS PARTIALLY KINKED AND ABRADING AGAINST ITSELF, AND THAT THIS IN COMBINATION WITH DEVICE USAGE OVER TIME CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBING AT THIS SITE. EACH OF THESE SITES CWOULD ALLOW THE LOSS OF FLUID, HOWEVER, BECAUSE THE PROVIDED INFO DID NOT INDICATE A SPECIFIC LEAKAGE SITE, QA IS PRECLUDED FROM DETERMINING IF ONE OR ALL OF THESE SITES CONTRIBUTED TO THE REPORTED "FLUID LOSS."S
Q2 FIXED RED BROKEN X-BRACE. BROKEN AT WELD ON BOTTOM OF T TUBE.
PT WAS BILATERALLY IMPLANTED WITH SALINE PROSTHESIS ON 1/30/91. ON 9/3/91, THE PHYSICIAN NOTED THAT THE PT'S LEFT BREAST HAD DEVELOPED PAIN AND THE RIGHT PROSTHESIS HAD DEFLATED. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
IS THE EVENT FREQUENCY ADDRESSED IN IF "YES" IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN THE LABELING? IF "NO" IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? YES. IF "YES" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? NO.
PT ALLEGES RECEIVING BREAST IMPLANTS ON AN UNK DATE OF AN UNK MFR. PT ALSO ALLEGES HER HEALTH HAS BEEN ENDANGERED AND HER BODY IS NOW ABUSED BY SILICONE. PT'S LETTER STATES "MY CATEGORY FALLS IN THE 46-50 AGE GROUP (AT TIME OF IMPLANTS) AS WELL AS THE ATYPICAL NEUROLOGICAL OVERLAP SYNDROME CATEGORY AND THE ATYPICAL RHEUMATIC CATEGORY."
X-TUBE ASSEMBLY 18" X 17". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
THE PT FELL AND SUBSEQUENTLY EXPERIENCED PERSISTENT PAIN. REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA. BOTH DEVICES WERE REMOVED AND REPLACED.
SUMMARY OF EVAL: THE TIBIAL AND APTELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED INSERT AND PATELLA WEAR AND PATELLAR COMPONENT DISASSOCIATION AS THEY HAVE NOT BEEN RETURNED TO CO. THE LOT CODES HAVE NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL. INFO PROVIDED STATED THAT THE PT HAD FALLEN ON HER IMPLANT.
PT WAS BILATERALLY IMPLANTED WITH SMOOTH SALINE PROSTHEIS ON 6/20/96. ON 9/3/96 THE PHYSICIAN NOTED THAT THE LEFT BREAST HAD DEVELOPED AN INFECTION AND SWELLING AND THE RIGHT PROSTHESIS HAD DEFLATED. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "NO" IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? YES. IF "YES" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? NO.
REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THIS INCIDENT. SHOULD ADD'L INFO BWE RECEIVED, QA WILL REEVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES BEACUSE QA'S EXAM OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA DID NOT PERFORM A MICROSCOPIC EXAM. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE INFECTION REPORT. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QA INDICATES THIS LKOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FORM SOURCE OTHER THAN THE DEVICE.
PT ALLEGES RECEIVING BREAST IMPLANTS ON AN UNK DATE. PT ALSO ALLEGES HER RIGHT IMPLANT "HAS SET UP AND IS HARD AS A ROCK" AND AT NIGHT WHEN SHE TRIES TO SLEEP HER RIGHT ARM HURTS.
X-TUBE ASSEMBLY 18" X 18". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
510K #912002, 1 PERSON, SERIOUS INJURY, TYPE G.
PT ALLEGES RECEIVING BREAST IMPLANTS IN NOV. 1987 OF AN UNK MFR. PT ALSO ALLEGES FOR THE LAST SEVEN YEARS (I.E.1989) SHE HAS BEEN UNCERTAIN ABOUT WHAT COULD HAVE BEEN THE CAUSE FOR HER ACHES, DEPRESSION AND TIREDNESS. PT ALSO STATES FOR A LONG PERIOD OF TIME SHE HAS BEEN SUFFERING FROM SPORADIC DEPRESSION AND THEN SHE STARTED WITH SEVERE PAIN IN HER LEGS, BACK AND OTHER JOINTS, SHE BECAME "CRIPPLED" AND HER LAST AILMENT IS EXTREME FATIGUE.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE PATELLA.
ADD'L INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED FROM THE USER FACILITY. SUMMARY OF EVALUATION: AS RECEIVED, THE PATELLAR COMPONENT IS DISSASOCIATED ALTHOUGH NOT REPORTED TO HAVE BEEN IN THIS CONDITION IN VIVO. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PATELLAR COMPONENT IS NOT POSSIBLE AS THE LOT CODE WAS NOT SUPPLIED AND HAS BEEN OBLITERATED ON THE PART. THE INFO PROVIDED AND THE EXAMINATION RESULTS ARE INSUFFICIENT TO DETERMINE WHETHER THIS EVENT IS DEVICE RELATED. FILE #**840-19-96-09-17-C.
THIS EVENT WAS REPORTED AS: STENOSIS. NO FURTHER INFO PROVIDED.
PT ALLEGES RECEIVING BREAST IMPLANTS IN AUG, 1976 OF AN UNK MFR. PT ALSO ALLEGES THREE YEARS LATER (IE. 1979) SHE WAS SICK AND ONE DAY SHE WAS PARALYZED ON HER LEFT ARM AND LEFT SIDE. SHE HAS HAD PAIN FROM MORNING TO NIGHT AND HER DOCTOR COULD NOT FIND ANYTHING WRONG WITH HER. ON DEC. 13, 1994 SHE HAD REMOVAL AND REPLACEMENTS WITH DEVICES OF ANOTHER MFR AND UPON REMOVAL HER IMPLANTS WERE RUPTURED AND BROKEN. PT ALSO ALLEGES SHE IS A VERY "REDUSED" PERSON TODAY AND REPORTED HAVING "SICCA/SJOGREN", A HEART DISEASE, HER JOINTS ARE "GROWING", HER MEMORY IS GONE, HER HIPS AND LEGS "DON'T LIKE TO WALK MUCH", HER TEETH ARE FALLING OUT, SHE HAS INFECTIONS ALL OF THE TIME AND HER "IMMUNE SYSTEM IS FLAT BROKE."
PT IS STATUS POST BIPOLAR HIP REPLACEMENT DURING 1989. HE REPORTED THAT HE HAD LEFT HIP PAIN SINCE THE SURGERY. ON PHYSICAL EXAMINATION, THE PT'S LEFT LEG WAS ONE INCH SHORTER THAN THE RIGHT. HE COMPLAINED OF PAIN WITH AMBULATION. HE USES A CANE FOR ASSISTRANCE WHILE AMBULATING OUTSIDE. INTRAOPERATIVELY, LOOSENING AND SUBSIDENCE OF THE COMPONENT WAS FOUND. THE HIP DID NOT APPEAR INFECTED. INTRAOPERATIVE CULTURES WERE OBTAINED AND REPORTED AS NEGATIVE FOR ORGANISM GROWTH. A REVISION OF THE LEFT HIP PROSTHESIS WAS PERFORMED. THE FEMORAL COMPONENT WAS LOOSE. THE PT'S ORIGINAL SURGICAL PROCEDURE WAS PERFORMED BY ANOTHER PHYSICIAN AT A DIFFERENT FACILITY. ADD'L INFO OF D6. STEM 6279-4 010 NFWYC #4.
PREOPERATIVE ECHOCARDIOGRAM REVEALED MITRAL REGURGITATION. AT EXPLANT, NO TISSUE OR SUTURE WAS VISIBLE. ANOTHER 25MM MECHANICAL HEART VALVE IMPLANTED.
ON 4 MARCH, 1996, DR. IMPLANTED A 25MM MITRAL ST. JUDE MEDICAL MECHANICAL HEART VALVE (MODEL 25M-101). ON 1 OCTOBER, 1996, THIS VALVE WAS EXPLANTED BY DR. DUE TO MITRAL REGURGITATION, WHICH WAS REVEALED BY PREOPERATIVE ECHOCARDIOGRAM. AT EXPLANT, NO TISSUE WAS VISIBLE. DR. HAD NO COMPLAINTS ABOUT THE PERFORMANCE OF THIS VALVE. ANOTHER 25MM MITRAL ST. JUDE MEDICAL MECHANICAL HEART VALVE (MODEL 25M-101) WAS IMPLANTED. THE PATIENT'S INTRAOPERATIVE STATUS WAS REPORTED AS STABLE. INFO REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE FER ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH ST. JUDE MEDICAL SPECIFICATIONS AT THE TIME OF MFR. RESULTS OF THIS INVESTIGATION REMAIN INCONCLUSIVE DUE TO THE FACT ST. JUDE MEDICAL HAS NOT RECEIVED ADDITIONAL INFO, SUCH AS THE OPERATIVE REPORT, WHICH MAY HAVE AIDED IN THE EVALUATION OF THIS VALVE. THE CAUSE OF MITRAL REGURGITATION IS UNK; HOWEVER, TESTING PERFORMED AT ST. JUDE MEDICAL DIVISION INDICATED THE VALVE DID NOT EXHIBIT ANY INTRINSIC DEFECTS. THIS IS SUPPORTED BY THE FACT THAT DR. DID NOT HAVE ANY COMPLAINTS ABOUT THE VALVE'S PERFORMANCE.
THE PT EXPERIENCED HYPERTENSIVE/TACHYCARDIC EPISODE. THE VENTILATOR WAS DELIVERING PRESET BREATHS AND VOLUME. THE THERAPIST SUSPECTED THAT THE IMV BREATH RATE WAS CONSISTANT WITH THE PT'S EFFORTS.
THE PC BOARD HAS NOT BEEN EVALUATED BY THE MFR.
THIS EVENT WAS REPORTED AS: UNKNOWN. NO FURTHER INFO PROVIDED.
PT ALLEGES RECEIVING BREAST IMPLANTS ON MAR 11, 1990 OF AN UNK MFR. PT ALSO ALLEGES "IT HURTS A LOT AND I FEEL PAIN FREQUENTLY, BESIDES THE AESTHETICS PROBLEMS. THE RIGHT SIDE UTTERLY FALLEN AWAY, THE IMPLANT MOVED UNDER THE ARMPIT. THE LEFT SIDE IS ENCAPSULATED, HARD AS A STONE, RAISED UP." SHE ALLEGES A DEFECT ON HER BREAST.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THAT "DUE TO CLIP SCISSORING SO AS TO RESULT IN FAILED LIGATION ONE CASE HAS RESULTED INFECTION." THERE WAS NO CONSEQUENCE TO THE PT, HOWEVER, THERE WAS EXTENDED OP TIME. 8/23/96, THERE WERE NO INTERVENTIONS REQUIRED.
THIS EVENT WAS REPORTED AS: ENDOCARDITIS. NO FURTHER INFO PROVIDED.
F10: 2203: STAPHYLOCOCCAL INFECTION. H3: EVALUATION OF THE VALVE IN CO'S LABORATORY REVEALED VEGETATIVE MATERIAL AT THE STENT POST BETWEEN THE RIGHT AND LEFT CORONARY CUSPS WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA AND MULTIPLE DISRUPTIONS. X-RAY ANALYSIS REVEALED NO APPARENT CALCIFICATION. STENT DISTORTION WAS NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THE VALVE WAS DETERMINED TO BE DUE TO STAPHYLOCOCCAL ENDOCARDITIS, AS REPORTED CLINICALLY. H6: 86 = X-RAY ANALYSIS.
TERMINALLY ILL, AGITATED PT VERY RESTLESS DURING THE NIGHT, PUT PRESSURE ON BED RAILS. BED RAILS SPONTANEOUSLY RELEASED FROM BED FRAME. PT FELL OUT OF BED TWICE.
AS STATED BY THE USER FACILITY, THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND HAS NOT BEEN RETURNED TO THE MFR. SUMMARY OF EVALUATION: EVALUATION OF THIS EVENT CANNOT BE PERFORMED BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. THE DEVICE HISTORY RECORD FOR THE LOT CODE OF THE HIP STEM WAS REVIEWED AND NO DISCREPANCIES WERE OBSERVED. THE DEVICE HISTORY RECORD FOR THE FEMORAL HEAD CANNOT BE REVIEWED AS THE LOT CODE WAS NOT PROVIDED. THE INFO PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THIS EVENT IS ASSOCIATED WITH THE DEVICE. FILE # **840-19-96-09-17-D.
THIS EVENT WAS REPORTED AS: "DISEASED" NO FURTHER INFO PROVIDED.
PT ALLEGES RECEIVING A LEFT BREAST IMPLANT ON JULY 23, 1991 OF AN UNK MFR AND AS A REPLACEMENT FOR ONE RECEIVED OF ANOTHER MFR. PHYSICIAN'S LETTER STATES DESPITE PROPHYLACTIC ANTIBIOTICS, THE PT DEVELOPED A POST OPERATIVE INFECTION IN THE LEFT BREAST NECESSITATING A DEVICE REMOVAL OF THIS PROSTHESIS AND SUBSEQUENT REPLACEMENT ON OCT 1, 1991 WITH A DEVICE OF AN UNK MFR. PT ALLEGES SUFFERING RHEUMATISM, SEVERE HIP PAINS, FEET PAINS, BRONCHITIS 6-7 TIMES ANNAULLY, CYSTITIS, MIXED CONNECTIVE TISSUE DISEASE AND ATYPICAL RHEUMATIC SYNDROME. REFERENCE MW072498A, MW072498B.
THIS EVENT WAS REPORTED AS ENDOCARDITIS AND DISRUPTION. NO FURTHER INFO PROVIDED.
S/P LEFT BREAST CA WITH AXILLARY INVOLVEMENT. S/P LEFT MASTECTOMY WITH SECONDARY RECONSTRUCTION. S/P LEFT CHEST RADIATION.
THIS IS THE SAME PT/EVENT AS MFR.#2219689-1996-00146. SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVALUATION: AS RECEIVED, BOTH TIBIAL INSERTS EXHIBIT MODERATE WEAR ON THEIR CONDYLAR SURFACES. THE LEFT KNEE INSERT DISPLAYS A WEAR PATTERN INDICATING A SIGNIFICANT INTERNAL MAL-ROTATION. THE RIGHT KNEE INSERT SHOWS A MORE SYMMETRICAL WEAR PATTERN WITH AN APPROXIMATE 5 DEGREE MAL-ROTATION. THE LOT CODES SUPPLIED WERE FOR THE BASEPLATES AND NOT THE TIBIAL COMPONENTS, SO THAT A REVIEW OF THESE DEVICE HISTORY RECORDS IS NOT POSSIBLE. THEREFORE,  RIGHT KNEE IMSERT WAS AVAILABLE FROM THE PART AND A REVIEW OF ITS DELIVERY HISTORY RECORD FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MFG. THE INFO PROVIDED AND THE EXAM RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALIGNMENT. HOWEVER, THE OBSERVED WEAR ON EITHER INSERT IS NOT NECESSARILY UNUSUAL FOR THE REPORTED PERIOD OF IMPLANTATION.
TUBING BROKE OFF THE DRAINAGE SYSTEM AT THE LEVEL OF THE BURETROL.
THIS EVENT WAS REPORTED AS "DEGENERATION "AND REGURGITATION. NO FURTHER INFO PROVIDED.
PT ALLEGES RECEIVING A RIGHT BREAST IMPLANT ON JULY 23, 1991 OF AN UNK MFR AND AS A REPLACEMENT FOR ONE RECEIVED OF ANOTHER MFR. PHYSICIAN'S LETTER STATES IN DEC 1991 THE IMPLANT DEVELOPED PROBLEMS WITH THE RIGHT BREAST NECESSITATING REMOVAL AND SUBSEQUENT REPLACEMENT OF THIS PROSTHESIS ON DEC. 4, 1991 WITH A DEVICE OF AN UNK MFR. PT ALLEGES SUFERING RHEUMATISM, SEVERE HIP PAINS, FEET PAINS, BRONCHITIS SOMETIMES 6-7 TIMES ANNUALLY, CYSTITIS, MIXED CONNECTIVE TISSUE DISEASE AND ATYPICAL RHEUMATIC SYNDROME. REFERENCE MW072498, MW072498B.
DURING LAPARASCOPE PROCEDURE, DISPOSABLE TROCAR PUNCTURED VEIN. (PHYSICIAN SUSPECTED MALFUNCTIONS). ANOTHER PHYSICIAN CALLED IN TO SUTURE. OPENED AND DID EXPLORATORY LAP&BELTUBAL WITH SUTURING OF ILIAC VEIN.
THIS EVENT WAS REPORTED AS AN EMBOLI. NO FURTHER INFO PROVIDED.
PT WAS REFERRED TO ELECTROPHYSIOLOGY LABORATORY FOR ICD GENERATOR CHANGE DUE TO PREMATURE END OF LIFE OF THE DEVICE.
DRAIN BROKE IN HALF AS IT WAS BEING REMOVED FROM THE PT'S ABDOMEN. S/P EXPLORATION OF COMMON BILE DUCT, LYSIS OF ADHESIONS, CHOLEDOEHOLITHOTOMY T-TUBE CHOLEYSTOGRAM ON 8/19/96. PT WAS RETURNED TO OR 8/24/96 FOR EXPLORATION AND REMOVAL OF RETAINED DRAIN. DRAIN WAS FOUND AND REMOVED BELOW THE ABDOMINAL WALL. THE ABDOMINAL WALL WAS CLOSED WITH ABSORBABLE SUTURE. THE ASCITIC FLUID WAS LEAKING, BUT THIS WAS SUCTIONED OUT. THEN SUBQ STITCHES WERE ALSO PUT IN PLACE WITH ABSORBABLE SUTURE AND THE AREA WAS CLOSED WITH STAPLES. ESTIMATED BLOOD LOSS WAS MINIMAL, THERE WAS 1100 CC OF ASCITIC FLUID DRAINED.
PT ALLEGES RECEIVING A LEFT BREAST IMPLANT IN OCT 1991 AND A RIGHT BREAST IMPLANT IN DEC 1991 OF AN UNK MFR. PHYSICIAN'S LETTER STATES ON DEC 2, 1994 THE PT'S RIGHT PROSTHESIS WAS COMPLETELY DEFLATED AND NOT PALPABLE WITH NO RESIDUAL BREAST TISSUE PRESENT. THE LEFT BREAST HAD BAKER GRADE III CAPSULAR CONTRACTURE WITH PROSTHESIS SITUATED MEDIALLY AND TOO HIGH; THEREFORE. PT HAD REMOVAL AND REPLACEMENT OF BOTH IMPLANTS ON JAN 23, 1995 WITH SALINE DEVICES OF ANOTHER MFR. PT ALLEGES SUFFERING RHEUMATISM, SEVERE HIP PAINS, FEET PAINS, BRONCHITIS SOMETIMES 6-7 TIMES ANNUALLY, CYSTITIS, MIXED CONNECTIVE TISSUE DISEASE AND ATYPICAL RHEUMATIC SYNDROME. REFERENCE MW072498, WM072498A.
CUSTOMER WAS REMOVING A POSITIVE VIAL FROM THE INSTRUMENT WHEN THE NECK OF THE BOTTLE SNAPPED OFF. CUSTOMER WAS CUT ON THE SECOND FINGER OF THE RIGHT HAND. TECHNICIAN WAS WEARING GLOVES BUT THE GLASS CUT THROUGH THE GOLVE. BOTTLE WAS CONFIRMED POSITIVE FOR MICROBACTERIA ON GRAM STAIN.
REFERENCE PIR NO. 1-11626 LOT NUMBER OF PRODUCT IS NOT AVAILABLE. IN AN ATTEMPT TO REMOVE THE BROKEN VIAL FROM THE CELL IT WAS DESTROYED. LOT NUMBER IS NOT RETRIEVABLE. TECHNICIAN ADMINISTERED HYDROGEN PEROXIDE TO THE CUT.
DEVICE NOT EVALUATED. DEVICE NOT RETURNED. EVENT CONCLUSION CPI RECEIVED A MEDWATCH FORM FROM THE USER FACILITY INDICATING THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED ON 9/25/96. CPI ALSO RECEIVED INFO THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED TWO DIFFERENT FAULT CODES WHEN THE PHYSICIAN WAS ATTEMPTING TO PERFORM A DIAGNOSTIC CAPACITOR FORM. CPI WILL ANALYZE THE ICD WHEN RETURNED, AND SUBMIT ADDITIONAL INFO TO THE FDA. THE ICD WAS NOT RETURNED TO CPI FOR ANALYSIS. THIS REPORT WILL BE UPDATED IF FURTHER INFO BECOMES AVAILABLE.
HIP PROSTHESIS HAD POLYETHYLENE WEAR WITH PERIACETABULAR OSTEOLYSIS NECESSITATING REVISION.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1975 OF AN UNK MFR. PT ALSO ALLEGES HER LEFT IMPLANT BEGAN LEAKING IN 1992. SHE DEVELOPED A POLYVALENT ALLERGIC DIATHESIS (INCLUDING FOOD) WITH SUCCEEDING DISPOSITION FOR INFECTIONS DUE TO IMMUNITY DEFICIENCY; THEREFORE, PT HAD REMOVAL IN 1993. PHYSICAIN'S LETTER STATES PT HAS SIGN OF IMMUNE DEFICIENCY, LIKEY CHRONIC FATIGUE SYNDROME.
LENS REPORTED TO BE DEFECTIVE BY SURGEON. THE LENS IS OFF CENTER. THE FIRST PROCEDURE WAS DONE ON 8/13/96 AND LENS REPLACEMENT WAS 9/10/96.
PHACO TIP FRAGMENTED DURING INTRAOCULAR SURGERY. FRAGMENTS WERE REMOVED FROM PT'S EYE  DURING PROCEDURE, THE USER FACILITY HAS STATED THAT THE EVENT DID NOT ADVERSELY EFFECT THE PT.
FACILITY HAS NOT RELEASED THE SUSPECT DEVICE FOR EVAL.
PT ALLEGES RECEIVING BREAST IMPLANTS ON AN UNK DATE AND OF AN UNK MFR. PT ALSO ALLEGES LEAKAGE ONLY SHOWS UP ON A SIDEWAYS MAMMOGRAPH, NOT ON A CHEST XRAY. THERE ARE DEFINITELY SMALL EMPTY POCKETS PRESENT AND ALSO A CERTAIN LOSS OF SHAPE ON THE LEFT. SHE STATES SHE HAS CONSIDERABLE PAIN, HER BLOOD SHOWS LITTLE EVIDENCE OF ARTHRITIS, SHE HAS ACHE IN HER BREAST AND UNDERARMS, BURNING ALL OVER, TIRED TO THE POINT OF EXHAUSTION, CHEST PAINS, BAND ABOVE THE WAIST, THE FEELING OF BRUISED BONES, ACHING JOINTS, NOT DIZZINESS, BUT MOVEMENT IN HER HEAD, IRRITABILITY, HAIR FALLING OUT, NAILS FLAKING AND UNCOMFORTABLE IN THE EARLY HOURS. PT ALSO ALLEGED, "WHEN MY KNEES WERE DONE THERE SHOULD HAVE BEEN AN END TO TROUBLE IN THAT AREA AT LEAST. AT FIRST, PAIN COULD BE ATTRIBUTED TO THE TRAUMA OF THE OP BUT, AS I MENTIONED, SINCE I LAST SAW THE PROOF THEY'VE BEEN DETERIORATING."
DURING A POST STENT DILATATION PROCEDURE, THE BALLOON WOULD NOT DEFLATE. A SYRINGE WAS USED TO DEFLATE THE BALLOON ENOUGH TO REMOVE. NO PT INJURIES OR COMPLICATIONS OCCURRED.
THE BALLOON CATHETER HAS BEEN DISCARDED BY THE HOSP, SO NO RETURNED PRODUCT ANALYSIS WILL BE AVAILABLE.
REPORTER ALLEGES PT RECEIVED AN IMPLANT ON AN UNK DATE AND HAD REMOVAL ON AUG 21, 1996 BECAUSE THE "PIN BROKE REQUIRING SURGERY TO REMOVE IT AND REPAIR FOOT."
REPORTER INDICATES DEVICE IS AVAILABLE FOR EVAL; THEREFORE, CO HAS REQUESTED DEVICE BE RETURNED.
THE IMPLANTED PORT AND CATHETER WAS NOT FUNCTIONING. UPON EXPLANTATIONS IT WAS DISCOVERED THAT THE CATHETER HAD BROKEN OFF FROM THE PORT. THERE WAS CONSIDERABLE FIBROUS TISSUE COVERING THE FREE END OF THE CATHETER.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE NEAR UPPER LEFT WELD.
CO RECEIVED A MEDWATCH FORM FROM THE USER FACILITY INDICATING THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND (DURING A FOLLOW-UP TEST) TO EXHIBIT A FAULT CODE. ALL CLINIC TESTING REVEALEDS ACCEPTABLE RESULTS, BUT THE PHYSICIAN ELECTED TO REPLACE THE ICD. IMPLANTED:4/7/95, EXPLANTED: 9/12/96 (IMPLANTED 17 MONTHS). THE ICD WAS RETURNED TO CPI AND FOUND TO MEET SPECIFICATION. THE BATTERY MONITORING VOLTAGE WAS 5.75 VOLTS AND BATTERY STATUS MEASURED MIDDLE OF LIFE(MOL). THE DEVICE HAS 3 DELIVERED AND 5 DIVERTED SHOCKS. THE CALCULTATED LONGEVITY TO 5.75 VOLTS IS 101.3% OF EXPECTED DEPLETION.
PT HAD A BURN ABOVE THE SURGICAL SITE AND MD BELIEVED IT WAS FROM THE ESU PENCIL.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CROSS BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO ITS IMPLOYEES, ITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ON 9/18/96, THE FACILITY NURSE CONTACTED THE MFR SALES SPECIALIST TO REPORT THAT UPON DEVICE EXPLANT THE PHYSICIAN NOTICED THAT THE DEVICE CATHETER WAS SHORTER AND HAS PRESUMED THAT A SEGMENT OF DEVICE CATHETER WENT INTO THE PT'S HEART.
THE MFR HAS COMPLETED ITS ANALYSIS OF THE RETURNED DEVICE AND THE RESULTS ARE AS FOLLOWS: THE DEVICE BODY, INCLUDING THE SEPTUM, SHOWED NO ANOMALIES. INTERNAL DAMAGE WAS NOT FOUND. THE 1-3/4" DEVICE CATHETER SHOWED EVIDENCE OF "PINCH-OFF" SYNDROME AT THE DISTAL END. THIS AREA APPEARED COMPRESSED AND ERRATICALLY CUT. THE DEVICE WAS PATENT AND DID NOT LEAK. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CATALOG/LOT NUMBER AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CATALOG/LOT NUMBER AND NO TRENDS WERE IDENTIFIED. THE FACILITY'S REPORT THAT THE DEVICE CATHETER HAD BROKEN WAS CONFIRMED BY THE MFR'S ANALYSIS OF THE RETURNED DEVICE. BASED ON OUR ANALYSIS RESULTS, THIS EVENT IS ATTRIBUTED TO "PINCH-OFF" SYNDROME. THE FACILITY AND PHYSICIAN WILL BE ISSUED AN ARTICLE EXCLUSIVE TO "PINCH-OFF" SYNDROME DIAGNOSIS FOR THEIR REVIEW IN AN ATTEMPT TO PREVENT RECURRENCE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT. NOTE: THE INITIAL REPORT WHICH WAS SUBMITTED FOR THIS EVENT ON 10/17/96 INCORRECTLY REPORTED THE IMPLANT DATE FOR THIS DEVICE AS 8/19/96. THE CORRECT IMPLANT DATE IS 8/19/94.
DR WAS USING DRILL WITH DRILL BIT TO DRILL HOLES IN THE BONE OF THE KNEE WHEN THE TIP OF THE DRILL BIT BROKE OFF IN THE PT'S BONE. ATTEMPTS WERE MADE TO REMOVE, WITHOUT SUCCESS. PT AND FAMILY WERE NOTIFIED BY THE DR.
BASED ON INFO REPORTED BY THE USER FACILITY IN THIS CASE, THERE WAS NO DEVICE MALFUNCTION ON THE PART OF THE SPEAKING VALVE. PT DEATH OCCURRED DUE TO ERROR OF THE DEVICE (TRACHEOSTOMY TUBE CUFF WAS INFLATED BY A HEALTH PROFESSIONAL WHILE THE VALVE WAS STILL INPLACE. AS THE MFR OF THE VALVE, CO TAKES SPECIAL CARE TO PACK EVERY VALVE WITH AN EXTENSIVE INSTRUCTION BOOKLET AND CAUTION LABELS THAT SPECIFICALLY STAT THAT THE TRACHEOSTOMY TUBE CUFF MUST BE DEFLATED WHEN THE VALVE IS IN PLACE. THE CAUTION LABELS ARE DESIGNED TO BE PLACED ON THE TRACHEOSTOMY, TUBE AS WELL AS AT BEDSIDE OR ON THE PTS' CHART. THIS UNFORTUNATE INCIDENT WA DUE TO HUMAN ERROR.
BASED ON INFO REPORTED BY THE USER FACILITY IN THIS CASE, THERE WAS NO DEVICE MALFUNCTION ON THE PART OF THE SPEAKING VALVE. PT DEATH OCCURRED DUE TO USER ERROR OF THE DEVICE (TRACHEOSTOMY TUBE CUFF WAS INFLATED BY A HEALTH PROFESSIONAL WHILE THE VALVE WAS STILL IN PLACE). AS THE MFR OF THE VALVE, CO TAKES SPECIAL CARE TO PACK EVERY VALVE WITH AN EXTENSIVE INSTRUCTION BOOKLET AND CAUTION LABELS THAT SPECIFICALLY STATE THAT THE TRACHEOSTOMY TUBE CUFF MUST BE DEFLATED WHEN THE VALVE IS IN PLACE. THE CAUTION LABELS ARE DESIGNED TO BE PLACED ON THE TRACHEOSTOMY TUBE AS WELL AS A BEDSIDE OR ON THE PTS' CHART. THIS UNFORTUNATE INCIDENT WAS DUE TO HUMAN ERROR.
MEDICAL EXAMINER CALLED AND REPORTED AN ACCIDENTAL DEATH DUE TO ASPHYXIATION. HIS CUFF OF THE PT'S TRACHEOSTOMY TUBE WHILE THE PT WAS WEARING THE SPEAKING VALVE. DEATH OCCURRED DUE TO HUMAN ERROR PER MEDICAL EXAMINER AND HSP CONTACT. MEDICAL EXAMINER NOTIFIED CO ON 9/17/96.
MEDICAL EXAMINER CALLED AND REPORTED AN ACCIDENTAL DEATH DUE TO ASPHYXIATION. HIS REPORT INDICATED A STAFF MEMBER INFLATED THE CUFF OF THE PT'S TRACHEOSTOMY TUBE WHILE THE PT WAS WEARING THE SPEAKING VALVE. DEATH OCCURRED DUE TO HUMAN ERROR PER MEDICAL EXAMINER AND HOSP CONTACT. MEDICAL EXAMINER NOTIFIED CO ON 9/17/96.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, IT CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY WITH OPERATIVE CHOLANGIOGRAMS, TWO OF FIVE 12 MM X-LONG TROCAR SLEEVES FRAGMENTED AT THE TIP OF TWO (2) TROCARS PROLONGING THE SURGERY FOR RETRIEVAL OF THE PIECES. UNABLE TO RETRIEVE ONE PIECE. AT THE END OF THE CASE, THE THREE REMAINING SLEEVES WERE INSPECTED FINDING TWO OF THEM DAMAGED AT THE TIP WITH CRACKS ONLY AND THE THIRD HAD BROKEN AT THE PROXIMAL END WHERE THE SLEEVE MET THE EXTERNAL HANDLE.
ON 9/18/96, THE FACILITY NURSE CONTACTED A MFR NURSE AND REQUESTED TO KNOW IF LATEX IS PRESENT IN ANY COMPONENT OF THE DEVICE THE DEVICE HAS BEEN IMPLANTED FOR APPROX 4 YEARS IN A PT WITH CYSTIC FIBROSIS. THERE HAVE BEEN NO PROBLEMS UNTIL 3 MONTHS AGO AT WHICH TIME, THE PT BEGAN TO EXPERIENCE "ANAPHYLACTIC SHOCK" EVERY TIME THE DEVICE WAS ACCESSED FOR USE. THE PT REACTED EVEN WHEN THE INJECTATE WAS PERSERVATIVE FREE SALINE. SUBSEQUENT TESTING HAS DEMONSTRATED THE PT TO HAVE AN ALLERY TO LATEX. THE MFR NURSE INFORMED THE FACILITY NURSE THAT THERE IS NO LATEX PRESENT IN ANY COMPONENT. OF THE DEVICE AND ALSO INFORMED THE FACILITY NURSE OF THE MATERIALS OF CONSTRUCTION. THE MFR NURSE REQUESTED TO KNOW THE PT AND PHYSICIAN INFO: HOWEVER THE FACILITY NURSE WAS UNABLE TO PROVIDE MORE INFO. HOWEVER, WOULD SPEAK WITH PHYSICIAN.
THE MFR CONTACTED THE FACILITY FOR ADDITIONAL INFORMATION ON THIS EVENT, HOWEVER, ATTEMPTS HAVE BEEN UNSUCCESSFUL. SINCE CO HAS BEEN UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION ON THIS INCIDENT, INVESTIGATION OF THIS EVENT WAS LIMITED TO A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. STRATO/INFUSAID'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE CUSTOMER WILL BE NOTIFIED OF CO'S MFR INVESTIGATION OF THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE REPORTER STATED THAT HIS DAUGHTER WAS ADMITTED TO THE HOSP FOR SYMPTOMS OF NAUSEA, WHERE AN HEMOGLOBIN A1C TEST GAVE A RESULT OF 14. READINGS IN MEMORY WERE HIGH (ONLY 3 READINGS UNDER 200 FOR THE MONTH OF AUGUST). REPORTER CLAIMS THAT DISPLAY HAD BEEN GIVING RESULTS OF 145/125 AND TREATMENT WAS BASED ON DISPLAY RESULTS RATHER THAN RESULTS IN MEMORY.
A 5.5 FRENCH POLYURETHANE CATHETER SEPARATED FROM PORT AND MIGRATED TO SUPERIOR VENA-CAVA WHERE IT WAS SUCCESSFULLY RETRIEVED.
THIS EVENT WAS REPORTED AS: INSUFFICIENCY. NO FURTHER INFO PROVIDED.
BASED ON INFO REPORTED BY THE USER FACILITY IN THIS CASE. THERE WAS NO DEVICE MALFUNCTION ON THE PART OF THE VALVE. PT DEATH OCCURRED DUE TO USER ERROR OF THE DEVICE (TRACHEOSTOMY TUBE CUFF WAS INFLATED BY A HEALTH PROFESSIONAL WHILE THE VALVE WAS STILL IN PLACE). AS THE MFR OF THE VALVE CO TAKES SPECIAL CARE TO PACKAGE EVERY VALVE WITH AN EXTENSIVE INSTRUCTION BOOKLET AND CAUTION LABELS THAT SPECIFICALLY STATE THAT THE TRACH TUBE CUFF MUST BE DEFLATED WHEN THE VALVE IS IN PLACE. THE CAUTION LABELS ARE DESIGNED TO BE PLACED ON THE TRACH TUBE AS WELL AS AT BEDSIDE OR ON THE PT'S CHART. THIS UNFORTUNATE INCIDENT WAS DUE TO HUMAN ERROR.
MEDICAL EXAMINER CALLED TO REPORT PT'S DEATH DUE TO MECHANICAL OVER EXPANSION OF LUNGS WITH BILATERAL PNEUMOTHORACIES. MEDICAL EXAMINER'S REPORT CONCLUDED ACCIDENTAL DEATH DUE TO HUMAN ERROR. MEDICAL STAFF INFLATED CUFF OF TRACHEOSTOMY TUBE WHILE THE PT WAS USING THE SPEAKING VALVE.
DR. TRIED TO REMOVE INDWELLING PEG TUBE USING TRACTION METHOD. HOWEVER, WHEN TRACTION WAS APPLIED, PEG TUBE SEPARATED AT SITE OF INTERNAL BOLSTER, CREATING A FOREIGN BODY OF THE INTERNAL BOLSTER. PT NEEDED AN URGENT GASTROSCOPY AT THE BEDSIDE TO REMOVE AND PREVENT IT FROM OBSTRUCTING PYLORIS OR SMALL INTESTINE. IT WAS SNARED AND REMOVED WITHOUT PROBLEM. TUBE REPLACED.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIMS X-TUBE BROKEN AT THE LOWER PIVOT POINT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE RPORTABLE EVENT.
RN STATES MD WAS REMOVING THE PEG USING TRACTION AND THE DOME SEPARATED FROM THE TUBE. MD REMOVED THE TUBE AND ENDOSCOPICALLY RETRIEVED THE DOME USING A SNARE. UNKNOWN LENGTH OF TIME PEG WAS IN PLACE.
#10 COULD NOT EVALUATE AS PRODUCT NOT RETURNED CONTRARY TO D9, CONFIRMED. NO PRODUCT RETURNED VIA PHONE. #11 ALL INFO IN SEC D6 HAS BEEN FILLED IN BY CO BECAUSE THE USER FACILITY WAS UNABLE TO PROVIDE. 611996090056.
A 62-YR-OLD GENTLEMAN, APPROX TWO MONTHS AGO, UNDERWENT IMPLANTATION OF A CO'S VENTRICULAR ASSIST DEVICE. NOW, WITH MULTIPLE EPISODES OF LOW FLOW AND PHYSICAL EXAMINATION, RIGHT HEART CATHETERIZATION, ECHOCARDIOGRAPHY AND SUBSEQUENT VENTRICULOGRAPHY AS WELL AS FLUOROSCOPY OF THE DEVICE WAS CONSISTENT WITH DEVICE THROMBOSIS LIKELY SECONDARY TO DISCONNECT OF THE PNEUMATIC DRIVE LINE OR A RUPTURE OF SUCH WITHIN THE FIBROUS CAPSULE. PT BROUGHT TO THE OPERATING THEATER FOR RE-EXPLORATION. UPON EXAMINATION, IT WAS NOTED THAT THE PNEUMATIC DRIVE LINE WAS DISCONNECTED FROM THE DEVICE AT THE PNEUMATIC CONNECTION NIPPLE. THROMBUS WAS NOTED WITHIN THE OUTFLOW VALVE AND CONDUIT WHICH WAS REMOVED WITH THE PUMP. THE PUMP ITSELF APPEARED TO CONTAIN THROMBUS VISIBLE AT THE OUTFLOW AREA. THE DEVICE WAS REMOVED FROM THE OPERATIVE FIELD, OPENED AND INSPECTED AND NOTED TO BE FILLED WITH THROMBUS. THE SEROSANGUINOUS FLUID FROM WITHIN THE DRIVE LINE WAS OBVIOUSLY NOT FROM DIAPHRAGM RUPTURE BUT FROM BODY FLUIDS WITHIN THE PRE-PERITONEAL POCKET AND CAPSULE. AT THIS POINT, A NEW DEVICE WAS BROUGHT ONTO THE OPERATIVE FIELD BEING APPROPRIATELY CALIBRATED AND PRIMED.
VENTILATOR DELIVERED VOLUMES GREATER THAN SETTING. OBVIOUS OVERDISTENTION OF CHEST OBSERVED. SETTINGS IMMEDIATELY DECREASED WITH LESS BUT CONTINUED UNDESIRABLE EXCESS VOLUME. MACHINE REMOVED FROM PT. BVM VENTILATIONS CONTINUED UNTIL PT ABLE TO BREATH SPONTANEOUSLY. PT THEN EXTUBATED.
DEVICE LABEL CODES: 1701, 1738, AND 1746. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
THE GAS ALARM SOUNDED AND THE CONNECTIONS WERE CHECKED. NO BLOOD WAS NOTED IN THE TUBING. AN ATTEMTP WAS MADE TO REFILL THE IAB BUT THE ALARMS SOUNDED AGAIN. FLECKS OF BLOOD WERE THEN NOTED IN THE TUBING. THE PUMP WAS TURNED OFF AND THE DR. WAS NOTIFIED. TEN MINUTES LATER, FANK BLOOD WAS NOTED IN THE TUBING. IABP WAS DISCONTINUED WITHIN 30 MINUTES AFTER THE ALARM. AS A RESULT OF THE EVENT, THE PATIENT HAD AN ILEGO-FEMORAL THROMBOSIS ON 9/10/96. THE THROMBECTOMY WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE PATIENT WENT ONTO EXPIRE ON 9/17/96 DUE TO RENAL FAILURE AND AN UNREPAIRED ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD A CVA POST-OP LEFT FEMORAL OCCLUSION. THE PATIENT WAS MADE A "NO CODE" BY THE FAMILY AFTER RIGHT FEMORAL TOTAL OCCLUSION. THE PATIENT DID HAVE PALPABLE PULSES DURING PUMPING BUT LOST PULSES AFTER IAB REMOVAL. A SURGICAL REPAIR WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE SURGEON WAS UNABLE TO RESTORE BLOOD FLOW THROUGH THE AORTA. EVENT COMPLICATIONS: PT. WENT TO O.R. FOR THROMBECTOMY ON LT. LEG-RPT'D 9/16 & 10/11. PATIENT'S CURRENT STATUS: EXPIRED ON 9/17/96.
SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO BE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY, CO EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSABLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION". THE PT WAS IMPLANTED WITH A PROSTHESIS ON 2/14/96. ON 3/26/96 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED INFLAMMATION AND CAPSULAR CONTRACTURE IN HER RIGHT BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FO PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N.
BALLOON (PTCA) BURST AFTER INFLATION TO 20 ATM. BALLOON NOT COMPLETELY DEFLATED AND WHEN CROSSED LEFT MAIN HAD SPASM LEADING TO CARDIOVASCULAR COLLAPSE. DID NOT REQUIRE CPR. RECEIVED MEDICAL INTERVENTION AND IABP PROLONGED HOSP STAY.
PT COMPLAINED OF CONTINUAL PAIN IN RIGHT TEMPOROMANDIBULAR JOINT. THE RIGHT FOSSA-EMINENCE PROSTHESIS WAS EXPLANTED ON 8/20/96. (THIS EVENT WAS REPORTED IN MFR # 1721769-1996-00001). THE PHYSICIAN ELECTED TO EXPLANT THE LEFT PROSTHESIS ON 9/3/96. IN HIS OPINION, THE IMPLANTING SURGEON IMPROPERLY POSITIONED THE PROSTHESIS, AND HAD NOT PROPERLY SEATED THE BONE SCREWS USED TO SECURE THE PROSTHESIS.
AN EXPLANTED LEFT PROSTHESIS WAS RETURNED TO CO ON 9/9/96. THE EXPLANTING PHYSICIAN ALLEGED THAT THE DEVICE HAD BEEN IMPROPERLY POSITIONED BY THE IMPLANTING SURGEON. THERE WAS NO ALLEGATION OF THE DEVICE MALFUNCTION OR FAILURE. THE DEVICE WAS EVALUATED USING MASTER INSPECTION SHEET FOR THE PROSTHESIS WHICH WAS IN EFFECT AT THE TIME OF MFR. CRITICAL DIMENSIONS OF FLANGE LENGTH, POLISHED LENGTH, OVERALL LENGTH, WIDTH, HOLE SIZE, NUMBER OF HOLES AND THICKNESS WERE MEASURED. THESE MEASUREMENTS WERE COMPARED TO THE MASTER SPECS. ALL CRITICAL DIMENSIONS WERE WITHIN TOLERANCE. NO UNUSUAL WEAR WAS EVIDENT, HOWEVER, IT WAS NOTED DURING EVAL THAT BOTH SURFACES OF THE PROSTHESIS EXHIBITED SCRATCHES. THE SCRATCHES APPEARED "FRESH", POSSIBLY RELATED TO EXPLANT OF THE DEVICE. THEY WERE NOT CHARACTERISTIC OF EXPECTED DEVICE WEAR, AND DID NOT APPEAR TO BE WEAR RELATED. THE SUBJECT PROSTHESIS WAS ALSO MATCHED TO A 3-DIMENSIONAL INSPECTION "TEMPLATE" USED IN FINAL DEVICE INSPECTION. THE LATERAL FLANGE OF THE PROSTHESIS WAS FOUND TO BE SLIGHTLY BENT. ALTHOUGH NOT RECOMMENDED, IMPLANTING SURGEONS OCCASIONALLY BEND THE FLANGE SLIGHTLY, TO MORE CLOSELY MATCH THE CONTOUR OF THE BONE AT THE IMPLANT SITE. IT IS PROBABLE THAT THIS OCCURRED IN THIS CASE. THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT DEVICE WAS REVIEWED, AND NO RELEVANT ISSUES WERE FOUND. THE DHR INDICATED THAT THE DEVICE WAS IN SPECIFICATION, AND MATCHED THE 3-DIMENSIONAL TEMPLATE WHEN MANUFACTURED. IN SUMMARY, CO CONCLUDED THAT THERE WAS NO DEVICE FAILURE OR MALFUNCTION. NOTE: A RIGHT PROSTHESIS FROM THE SAME PT WAS RETURNED AT THE SAME TIME, AND EVALUATED IN THE SAME MANNER AS THE LEFT PROSTHESIS. THE RIGHT PROSTHESIS WAS ALSO FOUND TO BE WITHIN DIMENSIONAL SPEC. SIMILAR SCRATCHES WERE NOTED ON BOTH SURFACES OF THE LEFT PROSTHESIS, AND THE FLANGE WAS SLIGHTLY BENT, IN A MANNER SIMILAR TO THE FLANGE OF THE LEFT PROSTHSIS. EVAL OF THE RIGHT PROSTHESIS IS REPORTED IN CONJUNCTION WITH A SEPARATE MFR (1721769-1996-00001).
BZ X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE OF THE CTR BOLT.
DURING CIRCUMCISION DOCTOR STATED THAT BELL CLAMP MALFUNCTIONED. SUTURES WERE NEEDED.
THE PT WAS BILATERALLY IMPLANTED WITH PROSTHESIS ON 2/1/96. ON 2/13/96, THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION AND NECROSIS IN BOTH BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY, MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVAL ATTACH HERETO. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OR GREATER SEVERITY THAN STATED IN LABELING? N.
PT ADMITTED TO HOSP DUE TO INCREASED HEART RATE. CAUSE IS BELIEVED TO BE THAT DOSAGE INFUSED QUICKER THAN IT SHOULD HAVE. UNABLE AT THIS TIME TO EVALUATE PUMP; IT HAS NOT BEEN RETURNED YET. THIS WAS THIRD PUMP THAT PT HAD IN AS MANY WEEKS. NURSING BELIEVES SPOUSE OF PT MAY HAVE TAMPERED WITH INFUSION DEVICE.
ON 9/16/96, THE QUALITY ASSURANCE DEPT OF CORPORATION'S CARDIAC ASSIST DIV BECAME AWARE OF PT'S LOS OF PULSE WHEN TREATED BY EARLY IABP REMOVAL IN WHOM BYPASS SURGERY WAS PERFORMED BECAUSE OF IABP DEPENDENCE. ALSO LIMB LOSS OCCURRED IN TWO SHEATHED AND NO SHEATHLESS PTS. NON-ISCHEMIC COMPLICATIONS WERE ALSO SIGNIFICANTLY INCREASED WITH SHEATHED IABP INSERTION. THESE COMPLICATIONS OCCURRED BETWEEN 1993 TO 1996. THE INFO WAS REPORTED IN "THE SOCIETY OF THORACIC SURGEON." THE TITLE OF THE ARTICLE WAS SHEATHLESS INSERTION DEVREASES VASCULAR COMPLICATIONS ASSOCIATED WITH INTRAAORTIC BALLOON PUMP PLACEMENT.
THIS FORM WAS COMPLELTED BY THE MFR. THIS IS A LITERATURE REFERENCE ONLY.
DURING CIRCUMCISION PROCEDURE THE DOCTOR STATED THAT THE BELL CLAMP MALFUNCTIONED. PT REQUIRED SUTURES.
AT 1:30 AM FEEDING TUBE BECAME DISLODGED AND A NEW TUBE WAS INSERTED AND DETERMINED TO BE IN STOMACH BY AUSCULTATION. RESPIRATORY STATUS UNCOMPROMISED. FORMULA FEEDING GIVEN CONTINUOUSLY BY PUMP. APPROX 9 OR 10 AM, PT SAT UP IN CHAIR, BEGAN HAVING RESPIRATORY WHEEZING. X-RAY SHOWED FEEDING TUBE PULLED BACK TO LEVEL OF LARYNX. ASPIRATION OF SMALL AMOUNT OF FORMULA MAY HAVE OCCURRED. PT UNDERWENT TRACHEAL SUCTIONING AND WAS MOVED TO ICU FOR OBSERVATION.
MFG EVENT ID: RPIC 60281. REPORTER STATED THATTHE EVENT ALSO CONSTITUTED A PRODUCT PROBLEM. BASED ON THE INFO PROVIDED, CO HAS DETERMINED THERE WAS NO PROBLEM WITH THE PRODUCT.
THE DEVICE WAS REMOVED DUE TO "NON-PERFORMANCE; ROD WOULD NOT RETAIN A FIXED POSITION." AS REPORTED TO CO, ONLY ONE ROD WAS REMOVED.
ACCORDING TO AVAILABLE INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 15/7/91. ON 3/1/96 ONE OF CYLINDERS WAS EXPLANTED BECAUSE DEVICE WOULD NOT RETAIN A FIXED POSTION. IN A RECEIVED QUESTIONNAIRE, PHYSICIAN INDICATED FOLLOWING: "DEVICE STOPPED RETAINING FLEX - WOULD SPRING BACK," AT IMPLANT OBSERVATIONS WERE "NORMAL / GOOD RESULT", THERE WERE NO APPARENT CIRCUMSTANCES NOTED THAT MAY HAVE CONTRIBUTED TO THIS OCCURRENCE, THERE WAS NO INFO APPARENT IN PT'S HISTORY WHICH MAY HAVE CONTRIBUTED TO THIS OCCURRENCE, AT IMPLANT NO DIFFICULTY WAS EXPERIENCED, PT REPROTED DIFFICULTY WITH DEVICE USE "AS ABOVE" REFERRING TO COMMENT ABOUT DEVICE NOT RETAINING FLEX, PT USED DEVICE AS INSTRUCTED, AND DEVICE WAS NOT DAMAGED AT EXPLANT PROCEDURE. ONLY ONE CYLINDER WAS RECEIVED AND EVALUATED BY MFR. WHEN FLEXED 90 DEGREES IN EACH OF FOUR DIRECTIONS AND POSITIONED IN THE "UP" POSITION CYLINDER MAINTAINED A FLEXED POSITION. BASED ON QUALITY ASSURNACE'S EVAL, QA CAN NOT CONFIRM REPORTED FAILURE OF DEVICE TO RETAIN FLEX.
DURING A STONE REMOVAL PROCEDURE AND WHEN ATTEMPTING TO PASS A URETEROSCOPIC STONE BASKET THROUGH THE URETER WITHOUT THE USE OF URETEROSCOPE, THE PT'S URETER WAS PERFORATED. THE DR REMOVED THE BASKET, PLACED A MINISCOPE, SAW STONE AND RE-ENTERED URETER WITH SAME BASKET. STONE FELL THROUGH TEAR IN URETER. URETERAL STENT PLACED UNTIL URETER HEALS. DR ALLEGED TIP TOO SHARP.
PRODUCT IS CLEARLY INDICATED FOR USE THROUGH A URETEROSCOPE. LABELING STATES TO INSPECT THE DEVICE PRIOR TO USE AND DURING THE PROCEDURE. THE LABELING FURTHER STATES TO RETRACT THE INSTRUMENT TIP INTO THE SHEATH AND INSERT THE INSTRUMENT INTO THE URETEROSCOPE WORKING CHANNEL. ADVANCE THE URETEROSCOPE INTO THE URETER OR RENAL PELVIS THE UF DID NOT FILE A MEDWATCH REPORT. THE BASKET TIP IS STANDARD FOR A 3-FRENCH INSTRUMENT OF THIS TYPE.
THE DOCTOR NOTICED THAT THE INSTRUMENT DID NOT CLAMP TIGHT ENOUGH TO STOP BLOOD LOSS. ACORDING TO THE REPORTER THERE WAS NO PT INJURY AS A RESULT OF THIS EVENT.
INSTRUMENT WAS REC'D IN GOOD CONDITION. SERRATED AREA HAS NO NICKS OR GAPS. INSTRUMENT WAS FUNCTIONALLY TESTED AND FOUND TO FUNCTION AS INTENDED. COMPLAINT HISTORY FROM 1/1/93 TO PRESENT, HAD ONE OTHER INCIDENT OF PRODUCT NOT FUNCTIONING PROPERLY THAT WAS ALSO NOT CONFIRMED. DEVICE HISTORY DENOTES THAT 73 INSTRUMENTS TO DATE WITH THIS LOT CODE ARE IN THE FIELD WITH NO KNOWN FAILURE. THIS ISSUE MAY HAVE OCCURRED DUE TO SOME OBSTRUCTION THAT PREVENTED FULL CLOSURE OR THE INSTRUMENT WAS NEVER FULLY RATCHETED.
LAPAROSCOPIC CHOLECYSTECTOMY CLIP APPLIED TO ARTERY. CLIP CAME OFF THE ARTERY. THE CASE WAS CONVERTED TO AN OPEN PROCEDURE AND THE ARTERY LIGATED. THIS EXTENDED THE RECOVERY TIME AND HOSPITALIZATION OF THE PT.
THE PT WAS IMPLANTED WITH A SALINE ON 5/10/96. ON 5/30/96, THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION IN HER RIGHT BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY, MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION." IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N.
FILED PREIMPLANTATION TESTING. OPENING AND CLOSING PRESSURES WERE MUCH TOO HIGH.
THE EVALUATION PERFORMED BY CO INCLUDED A VISUAL EXAMINATION AND TESTING FOR PATENCY, PRESSURE/FLOW CHARACTERISTICS AND PREIMPLANTATION PRESSURE. MULTIPLE FOREIGN MATERIAL/PARTICLES WERE SEEN  UNDER THE MEMBRANE SEAT AREA. THE PRODUCT MET CO SPECIFICATIONS FOR PATENCY, BUT DID NOT MEET SPECIFICATIONS FOR PRESSURE/FLOW OR PREIMPLANTATION PRESSURE DUE TO THE FOREIGN MATERIAL/PARTICLES UNDER THE MEMBRANE SEAT AREA. THESE VALUES WERE LOW AS COMPARED WITH PRODUCT LABELING. THE COMPOSITION AND ORIGIN OF THE MATERIAL IS UNK. THE MFG RECORDS FOR THE PRODUCT COULD NOT BE REVIEWED AS NO LOT NUMBER WAS AVAILABLE. A SITUATION WHERE THE PRODUCT PERFORMANCE WAS TOO HIGH, AS REPORTED BY THE CUSTOMER, COULD NOT BE DUPLICATED BY THE LABORATORY. IN ADDITION, THE INFORMATION RECEIVED WITH THE PRODUCT INDICATED THAT AN OPENING PRESSURE TEST WAS ATTEMPTED. SUCH TESTING IS NOT APPLICABLE TO THE PROPER PERFORMANCE OF A CO VALVE.
PT WAS ON A CONTINUOUS INFUSION OF FLOLAN PER PUMP. PUMP AND SUPPLIES PROVIDED BY ONE PROVIDER. A DIFFERENT PROVIDER DISPENSED DRUG. THE CASSETTE WAS NOT COMPLETELY CONNECTED TO THE PUMP (ON APPROX. 8/24/96) THE PT BECAME SYMPTOMATIC AND SYMPTOMS WERE SEVERE BEFORE HUSBAND DISCOVERED THE PROBLEM. PT WAS HOSPITALIZED IN ICU. PT WAS IMPROVING FROM CRISIS WHEN SHE BECAME COMATOSE (9/7/96) PT DIED 9/8/96.
TWO SEPARATE MEDWATCH FORMS RECEIVED FROM REPORTER, FIRST PAGE ONLY RECEIVED ON 9/16/96, AT 14:36, SECOND REPORT RECEIVED 9/16/96, AT 17:00. FIRST REPORT CONTAINS INFO NOT INCLUDED ON SECOND REPORT, I.E. SUBDURAL HEMATOMA WAS DISCOVERED. DUE TO THE TYPE OF MEDICATION BEING INFUSED THE PT HAD TWO PUMPS, ONE AS A SPARE. AT THE PRESENT TIME IT IS NOT KNOWN WHICH PUMP WAS BEING USED AT THE TIME OF THE INCIDENT.
RECEIVED MEDWATCH REPORT OF FOLLOWING ON 9/30/96: "DURING RIGHT TOTAL SHOULDER ARTHROPLASTY THE 5.5MM BUR USED TO DRILL SNAPPED/SHATTERED. TIP AND PIECES RECOVERED."
EXTERNAL LAB SUMMARY IS ATTACHED. CORRECTIVE ACTION INCLUDED REVISED MATERIAL SPECIFICATION TO VENDOR. EXTERNAL LAB TESTED CURRENT LOT SAMPLES THAT WERE ACCEPTABLE. SUMMARY OF FINDING: THE FAILED DRILL EXHIBITED AN OVERLOAD MODE OF FAILURE THAT CAN BE ATTRIBUTED TO POOR BRAZING PRACTICES AND THE PRESENCE OF UNDESIRABLE ETA PHASE IN THE SHANK. THE PRESENCE OF POROSITY IN THE BRAZE MATERIAL AND ETA PHASE IN THE SHANK WOULD NOT PROVIDE THE STRUCTURAL STRENGTH REQUIRED AND WOULD CONTRIBUTE TOWARD A PROPENSITY FOR PREMATURE FAILURE OF THE DRILL.
ADMIT DX: CATARACT EXTRACT. WHILE TESTING THE PHACO HANDPIECE AND FOOT PEDAL PRIOR TO STARTING THE MAIN PHACOEMULSIFICATION PART OF THE CATARACT SURGERY, IT WAS NOTED THAT THE MACHINE WAS NOT WORKING IN THE PHACO OR ASPIRATION MODE. A DIFFERENT PHACO FOOT PEDAL, HANDPIECE AND TUBING WAS USED. STILL NO PHACO OR ASPIRATION MODE. THE MACHINE WAS THEN CHANGED OUT. PER THE PHYSICIAN, THE ANESTHESIA WAS STARTING TO WEAR OFF AND THE CORNEA STARTED TO BECOME MODERATELY HAZY. THE PHYSICIAN DETERMINED IT WAS NOT PRUDENT TO CONTINUE AS THE EDGES OF THE CORTEX COULD NOT BE SEEN WELL ENOUGH. PT WILL HAVE TO HAVE AN ADD'L PROCEDURE DONE AFTER THE EYE HEALS TO HAVE THE CORTEX REMOVED AND TO PLACE AN INTRAOCULAR LENS.
THE DEVICE WAS REMOVED DUE TO A "SUDDEN LOSS OF FLUID".
QA REQUESTED RETURN OF THE DEVICE FOR EVAL. HOWEVER, AT THIS TIME THE DEVICE HAS NOT BEEN RECEIVED. THEREFORE, QA IS PRECLUDED FORM CONFIRMING THE DR'S OBSERVATIONS OR COMMENTING ON THE CONDITION OF THE DEVICE, SHOULD ADD'L INFO AND/OR THE DEVICE BE RECEIVED, QA WILL RE-EVALUATE THIS OCCURRENCE AND PROVIDE AN ADDENDUM TO THIS REPORT.
IT WAS REPORTED THAT DURING PREPARATION OF THE DEVICE, THE HUB DETACHED FROM THE SHAFT. NO PT INJURY REPORTEDLY ASSOCIATED WITH THIS INCIDENT.
THE CATHETER WAS RECEIVED FOR EVALUATION ON 9/30/96. ANALYSIS INDICATED THAT THE HUB HAD SEPARATED FROM THE SHAFT. THE SHAFT PULLED OUT OF THE ADAPTATION CUP. THIS FAILURE MODE OCCURRED BECAUSE THE JACKET AND ADAPTATION CUP RECEIVED INADEQUATE HEAT AND THEREFORE, FAILED TO JOIN TOGETHER. CONFIDENTIAL: BASED UPON PMA #P810046/S160, SUBMITTED IN 11/95 AND APPROVED 12/28/95 SEVERAL CHANGES WERE MADE INVOLVING THE RANGE OF OPERATING SPECIFICATIONS FOR THE ADAPTATION EQUIPMENT, EQUIPMENT SET-UP, AND A VISUAL INSPECTION OF PROCESSED PARTS FOR CLARITY. THESE CHANGES HAVE BEEN IMPLEMENTED BY MFG. THE LOT NUMBER SPECIFIED FOR THIS INCIDENT INDICATES THIS DEVICE WAS MFG PRIOR TO THE CHANGES.
INVESTIGATION CONDUCTED. DR UNSURE OF CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
IT WAS REPORTED THAT WHILE USING THIS GUIDEWIRE, RESIDUE APPEARED TO BE FLAKING OFF ONTO THE HOSP STAFF. THERE HAS BEEN NO REPORT OF COMPLICATION ON INJURY RELATED TO THIS EVENT.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY/QUANTITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
IT WAS REPORTED THAT WHILE USING THIS GUIDEWIRE, RESIDUE APPEARED TO BE FLAKING OFF ONTO THE HOSP STAFF. THERE HAS BEEN NO REPORT OF COMPLICATION OR INJURY RELATED TO THIS EVENT.
THE PT WAS BILATERALLY IMPLANTED WITH PROSTHESIS ON 11/9/93. ON 1/4/96, THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED A HEMATOMA AND CAPSULAR CONTRACTURE IN THE LEFT BREAST (IT WAS LATER NOTED THAT THERE WAS NO HEMATOMA ONLY CAPSULAR CONTRACTURE) AND A DEFLATION OF THE RIGHT BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY, MENTOR H/S EXPRESSLY DENIES THAT ANY INFORMATION CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION." SEE PRODUCT EVAL ATTACHED HERETO. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N.
INVESTIGATION CONDUCTED. DR DOES NOT CITE A CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS FROM BOX D6. MODEL/CATALOG 5616HL/5616HL, 5616HL/5616HL. LOT NUMBER UNK. UNK.
PRE-OP LUNG SCAN REVEALED PULMONARY EMBOLUS IN PT WITH SEVERE, ACUTE CHOLECYSTITIS. SCHEDULED FOR 2-PART SURGERY WITH INSERTION OF FILTER TO OCCUR BEFORE CHOLECYSTECTOMY. SURGEON INTRODUCED JUGULAR GUIDE WIRE AND FILTER. GUIDE WIRE STUCK IN FILTER (UNDER FLUOROSCOPY), FRAYED, UNCOILED AND BECAME SEPARATED FROM OUTER BLUE COATING. UNABLE TO REMOVE GUIDE WIRE FROM PT. PT TRANSFERRED TO ANOTHER FACILITY FOR REMOVAL AND POSSIBLE CARDIO-THORACIC SURGERY. REMOVAL SUCCESSFUL WITHOUT MAJOR SURGERY PROCEDURE AND PT TRANSFERRED BACK.
THE DEVICE WAS IMPLANTED ON 4/10/96 FOR INFUSION OF CHEMOTHERAPY THROUGH THE GASTRODUODENAL ARTERY FOR TREATMENT OF CANCER. ON 9/17/96, A FACILITY REPRESENTATIVE CONTACTED AND STATED THAT THE PHYSICIAN WAS CALLED INTO THE HOSP "APPROXIMATELY TWO WEEKS AGO" AFTER REPORTS OF PT BLEEDING UPON ACCESSING THE DEVICE. THE PT WAS MOVED TO SURGERY TO EXPLANT WHERE THE PHYSICIAN REPORTED FINDING THE DEVICE CENTER SEPTUM REMOVED FROM THE DEVICE AND LYING IN THE DEVICE POCKET. THE PHYSICIAN REPORTED THAT THE PT IS DOING FINE AT THIS TIME.
ON 9/19/96, THE MFR SALES REP REPORTED THAT THE FACILITY HAD BEEN ACCESSING THE DEVICE FOR A DEVICE REFILL WHEN THE EVENT HAD OCCURRED. IN ADDITION, THE MFR SALES REPRESENTATIVE CONFIRMED THAT THE DEVICE CENTER SEPTUM HAD COMPLETELY DISLODGED FROM THE DEVICE. ON 9/19/96, THE MFR ATTEMPTED TO CONTACT THE PHYSICIAN TO OBTAIN ADD'L DETAILS CONCERNING THIS EVENT; HOWEVER, SHE WAS NOT AVAILABLE. THE MFR REQUESTED THAT THE PHYSICIAN CONTACT THE MFR WITH ADD'L INFO CONCERNING THE CIRCUMSTANCES SURROUNDING THIS EVENT; HOWEVER, THE PHYSICIAN HAS NOT RESPONDED TO DATE. THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED WITH THE FOLLOWING RESULTS: THE DEVICE CENTER SEPTUM WAS DISLODGED AS RECEIVED. MICROSCOPIC EVALUATION OF THE DEVICE CENTER AND PORT SEPTA MATERIAL REVEALED NO INTERNAL DAMAGE. THE PORT WAS PATENT. THE DEVICE DID NOT FLOW AFTER RESEATING THE DEVICE CENTER SEPTUM. BLOOD WAS FOUND IN THE FLUID EXPELLED FROM THE DEVICE RESERVOIR. A "POP OUT" PRESSURE TEST REVEALED THAT THE DEVICE CENTER SEPTUM BULGED OVER 50PSI. A PRESSURE OF 80 PSI DID NOT DISLODGE THE DEVICE CENTER SEPTUM. THE MFR WAS UNABLE TO INTRODUCE HIGHER THAN 80 PSI DUE TO THE NEEDLE PENETRATION MARKS EXPANDING AND CAUSING AIR TO ESCAPE. THE DEVICE CENTER SEPTUM COULD NOT BE DISLODGED. THE DEVICE DID NOT LEAK. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS PART/SERIAL NUMBER AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS PART NUMBER AND NO TRENDS WERE IDENTIFIED. THE FACILITY'S REPORT THAT THE DEVICE CENTER SEPTUM HAD DISLODGED FROM THE DEVICE WAS CONFIRMED BY THE MFR'S ANALYSIS OF THE RETURNED DEVICE. BASED ON THE RESULTS OF THE MFR'S ANALYSIS, THE CAUSE OF THIS EVENT APPEARS TO BE DUE TO OVER PRESSURIZATION/OVERFILLING OF THE DEVICE. PRESSURE TESTING PERFORMED DURING THE MFR'S ANALYSIS REVEALED THE DEVICE TO BE WITHIN SPECIFICATION. THE MFR SALES REPRESENTATIVE HAS BEEN NOTIFIED OF THE RESULTS OF CO'S ANALYSIS AND WILL FOLLOW UP WITH THE FACILITY TO DETERMINE IF AN IN SERVICE TRAINING IS REQUIRED. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
IT WAS REPORTED THAT THIS UPON EXAMINATION OF THIS DEVICE, VIA X-RAY IT WAS OBSERVED THAT THE ENDS OF THE STENT APPEARED TO BE UNRAVELLING. THERE HAS BEEN NO CLAIM OF INJURY RELATED TO THIS EVENT. THE DEVICE WAS NOT EXPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS.
CO HAS RECEIVED X-RAYS OF THE IMPLANTED DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE PHYSICIAN, WHO IS ON VACATION. A FOLLOWUP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADD'L INFO FROM THE INITIAL REPORTER.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT OF THE IMPLANT WITH THE TEMPORARY PROSTHESIS AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT COMPLAINED OF CONTINUAL PAIN IN RIGHT TEMPOROMANDIBULAR JOINT. THE RIGHT PROSTHESIS WAS EXPLANTED ON 8/20/96. THE EXPLANTING PHYSICIAN INDICATED THAT THE RIGHT PROSTHESIS HAD BEEN IMPLANTED IN CONJUNCTION WITH A RIB GRAFT, AND WAS PUSHING AGAINST THE RIGHT EAR CANAL, CAUSING PAIN. IN HIS OPINION, THE IMPLANTING SURGEON IMPROPERLY POSITIONED THE PROSTHESIS.
AN EXPLANTED RIGHT PROSTHESIS WAS RETURNED TO CO ON 9/9/96. THE EXPLANTING PHYSICIAN ALLEGED THAT THE DEVICE WAS EVALUATED USING THE MASTER INSPECTION SHEET FOR THE PROSTHESIS WHICH WAS IN EFFECT AT THE TIME OF MANUFACTURE. CRITICAL DIMENSIONS OF FLANGE LENGTH, POLISHED LENGTH, OVERALL LENGTH, WIDTH, HOLE SIZE, NUMBER OF HOLES AND THICKNESS WERE MEASURED. THESE MEASUREMENTS WERE COMPARED TO THE MASTER SPECS. ALL CRITICAL DIMENSIONS WERE WITHIN TOLERANCE. NO UNUSUAL WEAR WAS EVIDENT, HOWEVER, IT WAS NOTED DURING EVALUATION THAT BOTH SURFACES OF THE PROSTHESIS EXHIBITED SCRATCHES. THE SCRATCHES APPEARED "FRESH", POSSIBLY RELATED TO EXPLANT OF THE DEVICE. THEY WERE NOT CHARACTERISTIC OF EXPECTED DEVICE WEAR, AND DID NOT APPEAR TO BE WEAR RELATED. THE SUBJECT PROSTHESIS WAS ALSO MATCHED TO A 3-DIMENSIONAL INSPECTION "TEMPLATE" USED IN FINAL DEVICE INSPECTION. THE LATERAL FLANGE OF THE PROSTHESIS WAS FOUND TO BE SLIGHTLY BENT. ALTHOUGH NOT RECOMMENDED, IMPLANTING SURGEONS OCCASIONALLY BEND THE FLANGE SLIGHTLY, TO MORE CLOSELY MATCH THE CONTOUR OF THE BONE AT THE IMPLANT SITE. IT IS POSSIBLE THAT THIS OCCURRED IN THIS CASE. THE DHR FOR THE SUBJECT DEVICE WAS REVIEWED, AND NO RELEVANT ISSUES WERE FOUND. THE DHR INDICATED THAT THE DEVICE WAS IN SPEC, AND MATCHED THE 3-DIMENSIONAL TEMPLATE WHEN MFG. IN SUMMARY, CO CONCLUDE'S THAT THERE WAS NO DEVICE FAILURE OR MALFUNCTION. NOTE A LEFT PROSTHESIS FROM THE SAME PT WAS RETURNED AT THE SAME TIME AND EVALUATED IN THE SAME MANNER AS THE RIGHT PROSTHESIS. THE LEFT PROSTHESIS WAS ALSO FOUND TO BE WITHIN DIMENSIONAL SPEC. SIMILAR SCRATCHES WERE NOTED ON BOTH SURFACES OF THE LEFT PROSTHESIS, AND THE FLANGE WAS SLIGHTLY BENT, IN A MANNER SIMILAR TO THE FLANGE OF THE RIGHT PROSTHESIS. EVAL OF THE LEFT PROSTHESIS IS REPORTED IN CONJUNCTION WITH A SEPARATE MFR REPORT (1721769-1996-0002).
RPTR ALLEGES THAT HER 20-YR-OLD SON USED A COLD PACK AND IT LEAKED ON HIS LEG CAUSING CHEMICAL BURNS AND HE HAD TO GO TO THE DR TWO TIMES FOR MEDICAL TREATMENT.
THE DEVICE WAS APPLIED DURING A LAPAROCOPIC SIGMOID COLECTOMY. REPORTEDLY, PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/2/96 -MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
INVESTIGATION CONDUCTED. DR IS UNSURE OF CAUSE FOR FAILURE. DR CITES EXPOSURE OCCURRED AFTER STAGE 1 & RECESSION CONTINUED THRU HEALING PHASE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE WAS APLIED DURING A LAPAROSCOPIC GASTROJEJUNOSTOMY. REPORTEDLY, PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. THE SURGEON APLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/2/96 -MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITED INITIAL REPORT.
A CUSTOMER WITH AVERAGE SKIN COLOR CAME TO TAN FOR 20 MINS. CALLED 3 DAYS LATER TO REPORT SHE HAD SUFFERED 2ND TO 3RD DEGREE BURNS. SHE REPORTED THAT 3 HRS AFTER SHE HAD TANNED SHE WAS SHOWING A LITTLE COLOR. 2 DAYS AFTER TANNING WENT TO THE EMERGENCY ROOM SUFFERING OR CLAIMING SHE HAD RECEIVED 2ND AND 3RD DEGREE BURNS. SHE ALSO SAID THAT SHE RECEIVED THE BURNS EVERYWHERE ON HER BODY EXCEPT FOR HER LEGS.
INVESTIGATION CONDUCTED. DR CITES PT'S DIMINSIHED ORAL HYGIENE AS CAUSE FOR FAILURE; PT IS ALSO A BRUXOR. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS FROM BOX D6. MODEL/CATALOG 4514HL/4514HL. LOT NUMBER 953441.
REC'D MEDWATCH FORM UNEXPECTANTLY IN MAIL. ESOPHAGEAL PERFORATING DURING EGD. UNKNOWN IF PRODUCT ERROR OR USER ERROR.
#10 COULD NOT EVALUATE AS PRODUCT NOT RETURNED. #11 ALL INFO IN SEC F HAS BEEN FILLED IN BY CO BECAUSE THE USER FACILITY WAS UNABLE TO PROVIDE. ANY MISSING ELEMENTS FROM ATTACHED USER FACILITY MEDWATCH FORM IN UNKNOWN AND USER CANNOT PROVIDE. 611996090055.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIMS X-TUBE IS CRACKED ON THE BOTTOM PART.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OF INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, IT CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS APPLLIED DURING A LAPAROSCOPIC HERNIA REPAIR. REPORTEDLY, PNEUMOPERITONEUM LEAKED FROM THE DEVICE. THE SURGEON APLIED DURING DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
11/5/96. DEVICE EVALUATION INDICATED AND CODES IN H3 AND H6. ADDITIONAL DATA ENTERED IN D9.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. REPORTEDLY, THE SAFETY SHIELD WOULD NOT RETRACT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
11-5-96. ADDITIONAL DATA ENTERED IN D9, E1 (ADDRESS & PHONE #) & F5.  DEVICE INDICATED AND CODES ENTERED IN H3 AND H6.
X-TUBE ASSEMBLY 17" X 17". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE PUMP WAS IN USE ON A PT WHEN THE BATTERY ALARMS STARTED. THE PT WAS TRANSFERRED TO ANOTHER PUMP WITHOUT ANY COMPLICATIONS.
MFR CONTROL NO. DI96-208 THE PUMP WAS SERVICED BY THE HOSPITAL'S BIOMEDICAL DEPT. THEY FOUND THAT THE CHARGER SUPPLY WAS NON FUNCTIONAL. CO FORWARDED A REPLACEMENT CHARGER SUPPLY AND TWO STATIC RAM BATTERIES. THE PUMP THEN FUNCTIONED NORMALLY.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLELCYSTECTOMY. REPORTEDLY, THE SAFETY SHIELD WOULD NOT RETRACT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/2/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INTIAL REPORT.
THE DEVICE WAS IMPLANTED ON 8/8/96 FOR INFUSION OF DRUG THROUGH THE HEPATIC ARTERY. ON 9/21/96, THE RADIOLOGIST CONTACTED A MFR NURSE AND REPORTED THAT HE WAS READING A NUCLEAR STUDY WHICH WAS DONE ON 9/20/96 AND IT SHOWED THE DYE ACCUMULATED IN THE DEVICE CENTER CHAMBER. THE RADIOLOGIST CALLED TE PEOPLE INVOLVED IN PERFORMING THE STUDY AND WAS TOLD THAT APPARENTLY THE FACILITY NURSE HAD INJECTED THE CENTER OF THE DEVICE INSTEAD OF THE DEVICE PORT. THE RADIOLOGIST STATED THAT HE WAS INFORMED THAT THE DYE STUDY WAS BEING PERFORMED TO CHECK FOR DEVICE FUNCTION. THE ONCOLOGIST WANTED THE RADIOLOGIST TO CHECK DEVICE CATHETER PATENCY AND POSITION. THE MFR NURSE THEN FAXED THE RADIOLOGIST THE DEVICE PORT BOLUS INSTRUCTIONS AND WENT OVER THE PROCEDURE, INCLUDING ALL PRECAUTIONS. THE MFR NURSE ALSO FAXED THE DEVICE DECLOTTING PROCEDURE, IN THE EVENT THAT THE DEVICE CATHETER WAS OCCLUDED.
ON 9/27/96, THE MFR SALES REP REPORTED THAT HE HAD SPOKEN WITH THE PHYSICIAN WHO HAD ASSISTED IN THE IMPLANT OF THE DEVICE AND HE HAD CONFIRMED THAT NUCLEAR DYE HAD BEEN INJECTED INTO THE DEVICE CENTER RESERVOIR INSTEAD OF THE DEVICE PORT. THE PHYSICIAN STATED THAT SINCE THAT TIME, THE PORT HAD BEEN CHECKED FOR PATENCY AND WAS FOUND TO BE PATENT. IN ADDITION, THE PHYSICIAN STATED THAT HE BELIEVED THE DEVCE WAS FUNCTIONING AND THE PT HAD BEEN SCHEDULED FOR A PERFUSION STUDY THE FOLLOWING WEEK. ON 10/15/96, THE MFR SALES REP REPORTED THAT HE HAD SPOKEN WITH THE IMPLANT PHYSICIAN WHO STATED THAT HE HAD REDONE THE PERFUSION STUDY THROUGH THE DEVICE PORT AND THE RESULTS SHOWED GOOD PERFUSION. IN ADDITION, THE IMPLANT PHYSICIAN REPORTED THAT THE DEVICE IS "FUNCTIONING FINE" AND THE "MISTAKE" HAD BEEN CORRECTED. THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN.  NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS REPORT.
REAR S/F DAB PAINTED R Q2, REAR S/F DAB PAINTED L Q2. DEALER CLAIMS BROKEN RIGHT BEHIND WHERE BACK ATTACHES.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR OR ADMISSION BY DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SLEEVE BROKE. NO ADD'L INFO WAS AVAILABLE. THE DEVICE WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION.
10/2/96 -MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE PNEUMOPERITONEUM LEAKED. THE SURGEON USED A NEW INSTRUMENT. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/2/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE DEVICE WAS USED TO REMOVE TO LIGATE VESSELS DURING A GANGLION REMOVAL. REPORTEDLY, THE INSTRUMENT DID NOT PLACE CLIPS PROPERLY. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE PRODUCT WAS NOT RETURNED TO THE MFR FOR EVALUATION.
PT ON CONTINUOUS HEPARIN INFUSION TO MAINTAIN ANTICOAGULATION, VIA ANOTHER MFR'S PUMP. FREQUENT "OCCLUSION-PATIENT SIDE" ALARMS ACTIVATED BUT NO APPARENT OCCLUSION NOTED. ALL TUBING AND ALSO PUMP WAS CHANGED, HOWEVER SITUATION WITH ALARM CONTINUED. WHEN THE NEEDLE LOCK WAS DISCONNECTED IT WAS NOTED THAT THERE WAS NO FREE FLOW OF FLUID THROUGH THE NEEDLE. A THIRD LOCK WAS PRIMED, FLOW NOTED, AND ATTACHED TO THE "Y" SITE. THE PUMP INFUSED WITHOUT FURTHER ALARM. A SIMILAR SITUATION WAS REPORTED TO MFR ONE MONTH PRIOR TO THIS OCCURRENCE, WITH THE DEFECTIVE PRODUCT SENT TO THEM AT THAT TIME. (9/10/96) ALSO OF NOTE: THERE ARE AT LEAST THREE SIMILAR ANECDOTAL DESCRIPTIONS OF THIS PROBLEM, BUT PRODUCT WAS NOT SAVED. THIS ALSO REPORTED TO MFR'S QI 10/9/96. PT EXPERIENCED NO WIDE SWINGS IN APTT DUE TO INTERRUPTION OF MEDICATION ADMINISTRATION.
THE DEVICE WAS NOT CLINICALLY APPLIED. THE JAWS OF THE INSTRUMENT WOULD NOT OPEN PRIOR TO APPLICATION.
11/5/96 - SUPPLEMENTAL REPORT #1 SENT TO FDA. ADDITIONAL DATA ENTERED IN D9, E1 (INITIAL REPORTER NAME) AND E.3. DEVICE INDICATED AND CODES ENTERED IN H3 AND H6.
DUAL CHAMBER VOLUMETRIC INFUSION PUMP WAS SET TO INFUSE 1GM OF AMINOPHYLLINE IN 1000CC OF D5W AT 20CC/HR IN 8 HRS. 160CC TOTAL SHOULD HAVE INFUSED. 496 CC'S WAS DELIVERED.
SEVERAL EXTRAVASATIONS OVER THE PAST SEVEN MONTHS. THE AMOUNT OF CONTRAST EXTRAVASATED IS NOT KNOWN.
NO EQUIPMENT MALFUNCTION REPORTED. HOSPITAL DOES NOT REQUEST DEVICE EVAL. HOSPITAL PERSONNEL CONTACTED MFR FOR ARTICLES AND RECOMMENDATIONS FOR MINIMIZING EXTRAVASATIONS. HOSPITAL PERSONNEL DECLINES ADD'L TRAINING; NEW EQUIPMENT HAS BEEN PURCHASED AND TRAINING WILL BE PROVIDED AT THAT TIME. SUSPECT PT'S PRE-EXISTING CONDITION OR CATHETER SELECTION MAY BE CAUSE FOR EXTRAVASATION. THE INJECTOR CONTINUES TO BE USED.
DURING A LAPAROSCOPIC PROCEDURE STAPLING DEVICE FAILED TO STAPLE. IT DID CUT TISSUE BUT DID NOT STAPLE.
SMALL PIECE OF PLASTIC FOUND NEAR AND ABOVE CASSETTE IN IV LINE. PLASTIC FLOATING FREELY. LINE DC'D. THIS IS THE 9TH TIME RPTR HAS SEEN THIS IN THE LAST FEW MONTHS.
THE DEVICE WAS APPLIED DURING A PNEUMONECTOMY. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON MANUALLU SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. THE DISPOSABLE LOADING UNIT WAS RETURNED FOR EVALUATION. THE STAPLER IN WHICH THE DISPOSABLE LOADING UNIT WAS CLINICALLY FIRED WAS NOT RETURNED FOR EVALUATION. WITHOUT AN EVALUATION OF THE STAPLER, A RELIABLE CONCLUSION AS TO THE CAUSE OF THE DIFFICULTY REPORTED COULD NOT BE MADE. THE DISPOSABLE LOADING UNIT WAS RECEIVED WITH MULTIPLE MALFORMED STAPLES.
PRODUCT WITHIN SPECIFICATION. CANNOT CONFIRM "ERR DURING COUNTDOWN".
STAPLER MISFIRED. SUTURE LINE HAD TO BE HAND SEWN TO CLOSE.
THE DEVICE WAS USED DURING A COLON RESECTION. THE INSTRUMENT WOULD NOT OPEN. THE SURGEON FORCEFULLY REMOVED THE DEVICE FROM THE APPLICATION SITE AND DAMAGED THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/04/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED.  THE INCORRECT CALIBRATION CODE, IF USED TO PERFORM AN ASSAY, COULD RESULT IN HIGHER THAN EXPECTED RESULTS. THESE RESULTS UNDER CERTAIN CONDITIONS, COULD HAVE ADVERSE CLINICAL EFFECTS. NO INJURIES WERE REPORTED IN THE FIELD.
ALL AVAILABLE INFORMATION REGARDING THIS COMPLAINT WAS INVESTIGATED AND REVIEWED. ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT #T031) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LCD DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALLY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITH SPECIFICATION. CANNOS CONFIRM CALIBRATION CHANGE OR HIGH READINGS.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE ON THE COLON. REPORTEDLY, THE INSTRUMENT STAPLED THE LUMEN. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
IMPLANT ALLEGEDLY "CRACKED" DURING IMPLANTATION. FOLLOW-UP FINDINGS: AS PER PHYSICIAN, NO PT CONTACT, NO PT INJURY. DAMAGE NOTED WHEN PACKAGE OPENED. BROKEN DEVICE.
THE DEVICE HITORY RECODRD REVIEW REVEALED FTHAT THIS DEVICE WAS MANUFACTURED FTO REQUIREMENTS AND DISTRIBUTED INTACT. THERE IS NO INDCATION OF NON CONFORMANE. ALL DEVICES ON THIS PRODUCTION LOT PASSED FINAL INSPECTION WHICH INCLUDED A 100% VISUAL INSPECTION FOR TEARS, CUTS AND NICKS. A MICROSCOPIC INSPECTION OF THE "CRACKED SURFACE" OF THE RETURNED DEVICE NOTED SEVERAL SERRATED OPENINGS. THESE "CRACKS" AND / OR OPENINGS WERE PROBABLY CAUSED BY THE MISHANDLING OF THIS DEVICE SOMETIME AFTER DISTRIBUTION. THE LABELING ADEQUATELY INSTRUCTS THST THESE DEVICES ARE NOT TO BE OVER HANDLED OR MANIPULATED
REPORTER STATED, THE TIBIAL INSERTS DID NOT SEAT PROPERLY IN THE BASEPLATE. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS REC'D, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE TIBIAL INSERTS WERE VISUALLY AND DIMENSIONALLY INSPECTED AS REC'D. THE ANTERIOR LOCKING TAB OF EACH EXHIBITS SOME DISTORTION AS A RESULT OF THE INTRA OPERATIVE ASSEMBLY ATTEMPT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE INSERTS AND THE BASEPLATE FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. THE INFO PROVIDED AND THE EXAMINATION RESULTS ARE NOT CONCLUSIVE IN THE ABSENCE OF THE EVENT BASEPLATE.
PRODUCT WITHIN SPECIFICATION. INVALID CAL CODE 03A HOW IS THIS OBTAINED (CANNOT CONFIRM "CALIBRATION CHANGE").
CLOSE-UP ATTACHMENT FELL OFF CAMERA STRIKING PT'S WOUND ON R LOWER LEG.
THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
9/5/97-SUPPLEMENTAL REPORT 31 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
PT WITH TRACTION RETINAL DETACHMENT & PROLIFERATIVE DIABETIC RETINOPATHY OF THE LEFT EYE HAD 1) PARS PLANA VITRECTOMY, 2) MEMBRANE PEEL, 3) AIR-FLUID EXCHANGE, 4) SCERAL BUCKLE, SILICONE OIL, & 5) LASER. DURING THE PROCEDURE THE VITRECTOMY FOOT PEDAL WOULD NOT RELEASE. WHEN FOOT WAS TAKEN OFF IT KEPT RUNNING. NO HARM TO PT. LATER REPORTED THAT EITHER LIQUID OR & Q-TIP HAD CAUSED THE PROBLEM BY GETTING STUCK UNDER PEDAL.
THIS MEDWATCH REPORT WAS INITIALLY SENT TO DIFFERENT CO. THEN FORWARDED REPORT TO CO. THE PROBLEM WAS FOUND AND CORRECTED BY THE USER FACILITY.
POST-OP CANCER PT HAD A TISSUE EXPANDER. RT BREAST LEAKING, REMOVED 10/8/96. LT BREAST SALINE IMPLANT AND CAPSULE REMOVED 10/8/96. PT TO HAVE RECONSTRUCTION 11/96.
REPORTER STATED, THE TIBIAL INSERT AND BASEPLATE WOULD NOT MATE PROPERLY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE CAUSE OF THE DAMAGE TO THE LOCKING TAB IS UNK. UPON RETURNING THE SNAP TAB TO ITS ORIGINAL POSITION, THERE WAS NO DIFFICULTY IN ASSEMBLY.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT DUE TO A LEAK.
REPORT OF ALLEGED "NO AUDIBLE ALARM. FOUND DURING BENCH TEST".
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F. LABELING-#1738. TESTING BY MFR FOUND A NO AUDIBLE ALARM CONDITION AT POWER UP DUE TO TRANSISTOR Q10 ON THE DIGITAL BOARD BEING OUT OF SPECIFICATION. REPLACED Q10.
PADS ARE NOT PEELING APART CORRECTLY. DURING A CALL; CUSTOMER TRIED TO ATTACH PADS, BUT THEY WOULD NOT PEEL PART CORRECTLY. 6/14/96, 70 YEAR OLD MALE WAS IN CARDIAC ARREST, BACKING PULLED AWAY FROM ELECTRODES, ANOTHER SET OF PADS WAS APPLIED, THIS SET WORKED, PT TRANSPORTED TO HOSP, PT PRONOUNCED AT HOSP.
AUGMENTATION MAMMOPLASTY 14 HRS AGO WITH SILICONE GEL IMPLANTS. RIGHT IMPLANT INTACT WHEN REMOVED. LEFT IMPLANT RUPTURED BUT WELL INCAPSULATED WITH SCAR TISSUE. NO FREE SILICONE PRESENT.
A REPORT WAS RECEIVED WHICH INDICATED THAT PT HAD EXPERIENCED EITHER A RUPTURE OR DEFLATION OF RIGHT SIDE, ALTHOUGH LACK OF PRODUCT IDENTIFICATION PREVENTED SPECIFIC DIAGNOSIS. PT HAS ALSO EXPERIENCED LOSS OF HAIR, FATIGUE, JOINT PAIN, HEADACHES AND BREAST DISCOMFORT. DEVICES HAVE NOT BEEN EXPLANTED AT THIS TIME.
AS PER 21 CFR PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CUI CORPORATION THAT THE REPORT OR INFO THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. REPORTS ARE BASED ON INFO SUPPLIED TO CUI CORP. WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY OR COMPLETENESS. IT IS UNDERSTOOD THAT THE INFO MAY NOT REPRESENT FACT AFTER INVESTIGATION.
PT REPORTS HE HAS SUFFERED FROM A LOSS OF SENSATION AND THAT THE DEVICE HAS FAILED.
DURING A LAPAROSCOPIC TOUPE PROCEDURE, THE NEEDLE DISENGAGED INTO THE PT'S CAVITY. THE NEEDLE WAS RETRIEVED WITHOUT INCIDENT.
10/16/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
IT WAS REPORTED THAT BACKFLOW WAS NOTED FROM THE SECONDARY LINE INTO THE PRIMARY LINE. THERE WAS NO RESULTANT PT COMPLICATION.
THE SAMPLE WAS EVALUATED AND NO BACKFLOW WAS NOTED. ALTHOUGH THE BACKFLOW COULD NOT BE DUPLICATED WHEN THE CHECK VALVE WAS EXAMINED PARTICULATE WAS FOUND INSIDE THE VALVE BUT NOT ON THE SEALING SURFACE. IT IS SUSPECTED THAT THE PARTICULATE MAY HAVE CAUSED THE BACK FLOW AND THEN WAS WASHED THROUGH THE CHECK VALVE DURING THE ANALYSIS. THE MFR OF THE CHECK VALVE HAS BEEN NOTIFIED OF THIS ISSUE OF PARTICULATE. CHANGES HAVE BEEN MADE TO THE MFG PROCESS TO REDUCE THE LIKELIHOOD OF PARTICULATE BEING INTRODUCED INTO TH CHECK VALVE DURING MFG. SECTIONS A-1 NO PT IDENTIFIER WAS ASSIGNED AT THE USER FACILITY. A-4 THE WEIGHT OF THE PT WAS NOT DOCUMENTED BY THE USER FACILITY. SECTIONS A, B,D,F WERE FILLED OUT BY THE MFR. SECTION F-2 NO REPORT WAS FILED BY THE USER FACILITY. MFS REPORT DATE 10/11/96.
PT BROUGHT TO OR 9/25/96 FOR "REVISION OF TOTAL KNEE", POST-OP, IT WAS DISCOVERED THAT THE FEMORAL COMPONENT ORIGINALLY IMPLANTED (DATE UNKNOWN) HAD FAILED AND SPLIT. SURGEON NOR PT CAN RECALL IF PT HAD FALLEN PRIOR TO OR ADMISSION.
IT WAS REPORTED THAT THE CATHETER LUER EXTENSION TUBING SPLIT. THE PT WAS ADMITTED TO THE HOSP AND THE CATHETER WAS REMOVED AND REPLACED. THE CATHETER WAS DISCARDED AT THE HOSP.
THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT AND SERIAL NUMBER: CF181 002.
DURING AN UNSPECIFIED PROCEDURE, REPORTEDLY, THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE TISSUE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
AN UNSUBSTANTIATED LEGAL COMPLAINT WAS RECEIVED WHICH ALLEGES THAT PLAINTIFF RECEIVED BREAST IMPLANTS AND SUBSEQUENTLY DEVELOPED SCAR CONTRACTURE AND EXPERIENCED JOINT AND MUSCLE PAIN, AS WELL AS AUTOIMMUNE SYMPTOMS WHICH INCLUDE FIBROSITIS.
AS THE DEVICES WERE NOT RETURNED, NO PHYSICAL INVESTIGATION IS POSSIBLE, AND NO CONCLUSION CAN BE DRAWN. AS PER 21 CFR PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CUI CORP. THAT THE REPORT OR INFO THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO TO THE EVENT REPORTED. REPORTS ARE BASED ON INFO SUPPLIED TO CUI CORP. WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY OR COMPLETENESS. IT IS UNDERSTOOD THAT THE INFO MAY NOT REPRESENT FACT AFTER INVESTIGATION.
UPON DEPLOYMENT INTO A 20MM DIAMETER VEIN, THE DOME DID NOT FORM PROPERLY. THE DEPLOYED DOME APPEARED OBLONG SHAPED. THE FILTER FEET ADHERED TO THE WALL. NO ADD'L PROCEDURE WAS NECESSARY.
A BALLOON RUPTURED ON THE SECOND INFLATION AT EIGHT ATMOSPHERES DURING A RIGHT COMMON ILIAC ANGIOPLASTY. A PORTION OF THE BALLOON MATERIAL DETACHED IN THE PT AS THE CATHETER WAS BEING WITHDRAWN THROUGH A SHEATH. A PREVIOUSLY SCHEDULED BYPASS WAS SUCCESSFULLY PERFORMED AND THE PT REMAINS ASYMPTOMATIC. NO ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED SEGMENT. THIS DEVICE HAS BEEN RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION REVEALED THE DISTAL PORTION OF THE BALLOON MATERIAL WAS MISSING AND NOT RETURNED FOR EVALUATION. A CIRCUMFERENTIAL TEAR WAS LOCATED IN THE BALLOON APPROX TWO AND ONE HALF CENTEMETERS PROXIMAL TO THE DISTAL TIP. THERE WAS A KINK LOCATED ONE MILLIMETER PROXIMAL TO THE PROXIMAL RADIOPAQUE MARKER AND THE BALLOON MATERIAL WAS SCRATCHED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES ON THE BALLOON SURFACE. CO BELIEVES PT ANATOMY AND/OR USER TECHNIQUE MAY HAVE CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. CO'S DIRECTION FOR USE STATE: "IF RESISTANCE IS FELT WHEN REMOVING A CATHETER THROUGH AN INTRODUCER SHEATH, STOP AND REMOVE THEM AS A COMPLETE UNIT TO PREVENT DAMAGE TO THE GUIDEWIRE, CATHETER OR VESSEL."
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-RIGHT CYLINDER. ADD'L LOT AND SERIAL NUMBER: 9375T 006.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE KNIFE BLADE WOULD NOT RETRACT. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
DEVICE RETURNED TO MFR WITH STATEMENT "ROTOR NOT WORKING, VERIFIED UNDER FLUORO". DEVICE REPLACED. AS OF 9/25/96 PHYSICIAN'S OFFICE REPORTS THAT PT IS DOING WELL WITH NEW DEVICE. DEVICE IS UNDERGOING ANALYSIS AT THIS TIME.
04/09/1998: G9-MFR REPORT NUMBER CORRECTED HERE AND IN HEADER ON PAGE 1.
ADDITIONAL INFO RECEIVED ON 1/21/97 INDICATES REASON AS "NON-FUNCTIONING" PROSTHESIS.
A BLADDER NECK SUSPENSION PROCEDURE WAS PERFORMED WITHOUT INCIDENT IN 1/96. SEVERAL MONTHS FOLLOWING THE PROCEDURE, THE PT RETURNED WITH PAIN. NO SIGNS OF INFECTION WERE NOTED. A CT PERFORMED REVEALED AN ANCHOR HAD DISLODGED AND WAS FREE FLOATING. THE ANCHOR AND SUTURE WERE SURGICALLY REMOVED. THE PT REMAINED CONTINENT AND NO CULTURES WERE TAKEN FOR INFECTION. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. FOLLOW UP REVEALED THE PT REPORTEDLY HAD NOTICED A "BOIL" AT THE INCISION SITE PRIOR TO THIS EPISODE OF DISCOMFORT. NO TREATMENT WAS SOUGHT BY THE PT AT THAT TIME. THE PT'S DESCRIPTION OF EVENTS MAY INDICATE A PRIOR INCISIONAL INFECTION. HOWEVER, WITHOUT CULTURES AND/OR FURTHER INFO, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
DISTRIBUTOR WAS INFORMED ON AN EXPLANT REPORT THAT THERE WAS A SUSPECTED MALFUNCTION WITH THE MFR'S SENSE PACE LEAD. THERE WAS NO IDICATION THAT THE ICD DID NOT PERFORM TO SPEC.
THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OF CULPABILITY FOR ANY AND/OR ALL ASPECTS OF THIS EVENT, AND MAY BE BASED UPON INCOMPLETE AND / OR UNSUBSTANTIATED INFO.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE,
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
DEVICE WAS REMOVED FROM THE PT DUE TO HEMATOMA, PERINEAL SWELLING. THE CYLINDERS WERE REIMPLANTED. UNCERTAIN IF PUMP AND RESERVOIR WERE REIMPLANTED. CO HAS REQUESTED ADD'L INFO. ADD'L LOT AND SERIAL NUMBER: CD791 008.
VENTILATOR CIRCUIT HAD FALLEN APART AT CONNECTION OF BLUE CORREGATED TUBING NEAR THE PATINET END OF THE CIRCUIT. THIS PT IS TOTALLY VENTILATOR DEPENDENT. THE VENTILATOR ALARM WAS NOT TRIGGERED. THE PT WAS BEING MONITORED ON PULSE OXIMETRY AND WAS ASSESSED TO BE BLUE WITH 02 SATURATION LEVELS AT 30% AND HEART RATE 40. A CODE WAS CALLED AND THE PT WAS TRANSFERRED TO ICU.
DURING SERVICE OF PRODUCT, DEVICE WAS FOUND TO NOT CYCLE WITH ALL LEDS AND A CONSTANT SINGLE TONE ALARM, DUE TO INTEGRATED CIRCUITS U9, U27 AND U28 ON THE LOGIC BOARD BEING OUT OF SPECIFICATION. REPLACED U9, U27, AND U28.
THE DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPY WITH EXCISION OF A RIGHT OVARIAN CYST. A TROCAR WAS INTRODUCED INTO THE RIGHT LATERIAL QUADRANT TO ASPIRATE THE CYST. BLEEDING WAS NOTED AND A LACERATION OF THE RIGHT MID-COMMON ILIAC ARTERY WAS NOTED. A FORMAL LAPAROTOMY WAS PERFORMED TO REPAIR THE ARTERY. THE HOSP CONSIDERS THIS EVENT RELATED TO TECHNIQUE RATHER THAN DEVICE PERFORMANCE. EXPIRATION DATE: 6/30/01
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO MALFUNCTION-PUMP WENT FLAT AFTER TWO PUMPS. ADD'L INFO RECEIVED ON 8/24/96 INDICATES THE CYLINDERS HAD BLOWN APART.
DURING AN UNSPECIFIED PROCEDURE, THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY.
10/18/96 SUBMISSION OF INITIAL REPORT TO FDA BY MFR.
DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS, AND REPLACED.
THE BALLOON ON THIS BALLOON CATHETER RUPTURED ON THE THIRD INFLATION AND FRAGMENTS OF THE BALLOON MATERIAL DETACHED IN THE PT DURING A STENT EXPANSION FROM A CONTRALATERAL APPROACH. RESISTANCE WAS ENCOUTERED UPON WITHDRAWAL OVER A CALCIFIED AORTIC BIFURCATION. THE SHEATH AND BALLOON CATHETER WERE REMOVED AS A UNIT. THE PROXIMAL PORTION OF THE BALLOON WAS REMOVED WITH THE CATHETER SHAFT. A HEMOSTAT WAS USED TO SUCCESSFULLY RETRIEVE THE DETACHED DISTAL SEGMENT. ARTERIOGRAPHY POST PROCEDURE INDICATED DAMAGE TO THE RIGHT COMMON FEMORAL ARTERY AND OCCLUSION OF THE RIGHT EXTERNAL ILIAC ARTERY. DIFFICULTY ACHIEVING HEMOSTASIS FROM THE INSERTION SITE IN THE RIGHT COMMON FEMORAL ARTERY POST PROCEDURE WAS TREATED WITH PLACEMENT OF A PRESSURE CLAMP ON THE PT'S RIGHT GROIN. THE PT WAS TRANSFERRED TO THE MICU FOR OBSERVATION. THE PT EXPIRED THE DAY FOLLOWING THIS DILATATION PROCEDURE. CO'S FOLLOW UP INDICATED BALLOON FAILURE RESULTED FROM INFLATION OF A VASCULAR STENT WHICH IS A NON INDICATED USE FOR THIS BALLOON CATHETER. CO BELIEVES THIS PROCEDURE AS WELL AS NON-INDICATED USE OF THIS DEVICE MAY HAVE CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. CO'S DIRECTION FOR USE STATE: CO BALLOON DILATATION CATHETERS ARE RECOMMENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE ILIAC, FEMORAL AND RENAL ARTERIES. ANY USE FOR PROCEDURES OTHER THAN THOSE INDICATED IN THESE INSTRUCTIONS IS NOT RECOMMENDED."
DURING SERVICE OF PRODUCT A NO AUDIBLE ALARM CONDITION WAS FOUND DUE TO CAPACITOR C29 ON THE MOTOR BOARD BEING OUT OF SPECIFICATION. REPLACED C29.
DEVICE WAS REMOVED FROM THHE PT DUE TO PT DISSATISFACTION-WANTED A CX 3 PIECE. ANOTHER DEVICE WAS IMPLANTED.
THE MFR BECAME AWARE OF AN EVENT INVOLVING A 20FR INITIAL PLACEMENT GASTROSTOMY (PEG) FEEDING TUBE ON 9/9/96. WHILE PLACING THE DEVICE IN A PT, THE MIDDLE DILATING CONNECTOR BROKE AT THE TUBING JUNCTURE. THE DEVICE WAS ABLE TO BE REMOVED THROUGH THE PT'S MOUTH AS THE EXTERNAL BOLSTER HAD NOT PASSED THE ESOPHAGUS. THE DEVICE WAS REMOVED THROUGH THE PT'S MOUTH AND ANOTHER MANUFACTURER'S DEVICE WAS PLACED WITHOUT COMPLICATIONS. EXAMINATION OF THE ACTUAL PRODUCT SHOWS THE INCIDENT MAY BE USER RELATED AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE WHEN THE CONNECTOR BROKE. NO POTENTIAL FOR SERIOUS INJURY APPEARS PROBABLE FROM THE INFO OBTAINED. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. THIS INFO SHALL NOT BE CONSTRUED AS AN ADMISSION BY CO THAT THE PRODUCTS DESCRIBED HEREIN ARE OR WERE DANGEROUS IN ANY RESPECT, OR THAT ANY CASUAL RELATIONSHIP EXISTS BETWEEN THESE PRODUCTS AND ANY ACTUAL OR POTENTIAL INJURY. IN ADDITION, THE SUBMISSION OF A REPORT BY CO SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT DUE TO AN ANEURYSM OF THE RIGHT CYLINDER AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CYLINDER HAD TORN FABRIC AND BULGING.
DEVICE WAS REMOVED FROM THE PT DUE TO PAIN AND PT DISSATISFACTION.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. PACKAGING WAS DAMAGED.
PART OF THE GREEN COATING CAME OFF THE GUIDEWIRE DURING INSERTION. THE PT HAD AN EXPLORATORY OPERATION OF THE FEMORAL ARTERY TO REMOVE A PIECE OF THE COATING. THERE WERE NO PT COMPLICATIONS.
DURING SERVICE OF PRODUCT DEVICE WAS FOUND TO NOT CYCLE, WITH ALL LEDS AND A CONSTANT SINGLE TONE ALARM. UNABLE TO REPEAT FAILURE MODE. REPLACED LOGIC BOARD AS PRECAUTION.
VENTILATOR CIRCUIT HAD FALLEN APART AT CONNECTION OF BLUE CORRUGATED TUBING NEAR THE PT END OF THE CIRCUIT. THIS PT WAS NOT TRIGGERED. THE PT WAS BEING MONITORED ON PULSE OXIMETRY AND WAS ASSESSED TO BE BLUE WITH 02 SATURATION LEVELS AT 30% AND HEART RATE 40. A CODE WAS CALLED AND THE PT WAS TRANSFERRED TO ICU.
A LOT NUMBER WAS NOT AVAILABLE FOR A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PRODUCT. NO SAMPLES WERE RECEIVED FOR EVAL. BASED ON COMPLAINT TRENDING NO ADD'L COMPLAINTS HAVE BEEN REPORTED OF THIS NATURE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO HYDRAULIC ABNORMALITY.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE VISIBILITY WAS NOT CLEAR. THE SURGOEN APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
THE ENDS OF THE FILTER FLARED OUT WHILE TRYING TO PUT IT THROUGH THE INTRODUCER. THE FILTER WAS NOT USED ON THE PT.
INFO RECEIVED ON 9/19/96 INDICATES DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION, DATE NOT INDICATED. ANOTHER DEVICE WAS IMPLANTED. CO HAS  REQUESTED ADD'L INFO.
REPORT OF ALLEGED "ALL LEDS ON, SINGLE TONE ALARM, NO VOLUME DELIVERED. NO PT HARM".
708-TESTING BY THE MANUFACTURER FOUND DEVICE FULLY FUNCTIONAL.
NOTIFICATION OF IDE REVISION. (IOI STUDY #111).
THE DEVICE WAS USED DURING A LAP HERNIA REPAIR. IT WAS REPORTED THE TED 12 BALLOON RUPTURED ON THE THIRTY-FIFTH PUMP. THE SURGEON HAD TO RETRIEVE THE BALLOON FRAGMENTS AND WAS NOT SURE IF ALL WERE RETRIEVED. IT WAS ALSO REPORTED THERE WAS A TEAR IN THE PERITONEUM AND THE SURGEON CONVERTED TO AN OPEN PROCEDURE TO REPAIR IT.
H6; CODE 400: INSTRUMENT WAS RETURNED WITH A BALLOON WHICH HAD BURST AND WAS IN THREE PIECES.
COAG MODE WAS IN AN ACTIVATION STATE WHEN PLUGGED INTO THE ELECTROSURGICAL UNIT.
NO PT INJURY. USER FACILITY HAS NOT AND WILL NOT FILE A MEDWATCH REPORT. ON 10/4/96, THE PENCIL WAS TESTED AND THE REPORTED PROBLEM WAS VERIFIED. A MINUTE SOLDER TRACE ON THE PRINTED CIRCUIT BOARD WAS FOUND. THIS IS CONSIDERED VERY ISOLATED. MFG HAS BEEN INFORMED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFROMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE.
DEVICE WAS REMOVED FROM THE PT DUE TO A FLUID LOSS AT LEFT CYLINDER TUBING.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL. TUBING HAD A FATIGUE LEAK.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED FOLLOWING THE INITIAL PROCEDURE PT DEVELOPED SIGNS/SYMPTOMS OF BILE LEAKAGE. APPROX 2 DAYS POST-OP AN ERCP WAS PERFORMED AND PT WAS RE-LAPAROSCOPED. THE CLIPS WERE STILL ON CYSTIC DUCT BUT SLID DISTAL TO CHOLEDUCOLOTOMY. DR LIGATED CYSTIC DUCT WITH ENDO-LOOP. PT REPORTEDLY DOING WELL AT THIS TIME. BOTH PROCEDURES OCCURRED IN 7/96-SPECIFIC DATES UNK.
A4; B6,7; D10 SURGEON CONTACTED. INFO NOT PROVIDED. D5,6; H4 DEVICE NOT RETURNED FOR EVALUATION. INFO UNAVAILABLE. H6 INFO ANTICIPATED, BUT NOT AVAILABLE AT THIS TIME.
A BALLOON LEAK WAS NOTED AFTER 3 DAYS OF USE. THE IAB WAS REMOVED AND NOT REPLACED.
H-11 ALL UNK INFO REQUESTED BUT NOT REC H-11 SECTION F PROVIDED BY MANUFACT.
DEVICE WAS IMPLANTED ON 11/6/92. ON 5/6/93 A CONNECTOR WAS REVISED. ON 12/14/94 THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO EROSION.
DEVICE WAS IMPLANTED ON 11/6/92. A CONNECTOR WAS REVISED ON 5/6/93. THE LEFT CYLINDER WAS REMOVED ON 12/14/95. THE RIGHT CYLINDER WAS REMOVED FROM THE PT AND REPLACED ON 9/19/96 WHEN LEFT CYLINDER WAS REIMPLANTED.
ICU PERSONNEL WERE ATTEMPTING TO PERFORM A SYCHRONIZED CARDIOVERSION. ALLEGEDLY THE ADAPTER WOULD NOT DISCHARGE. A BACK UP ADAPTER WAS OBTAINED, USED AND THE PT WAS SUCCESSFULLY CARDIOVERTED.
CO EXAMINED THE DEVICE AND OBSERVED AN INTERMITTENT FAILURE OF THE ADAPTER TO DISCHARGE. FURTHER INVESTIGATION REVEALED AN INTERMITTENT CONTACT IN THE DISCHARGE SWITCH. THE DEVICE WAS REMOVED FROM SERVICE AND THE CUSTOMER WAS SHIPPED A NEW UNIT. SECTION A: SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE IN ACQUIRING PATIENT INFORMATION AND HISTORY FROM THE REPORTER.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE VISIBILITY WAS NOT CLEAR. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEUDRE, THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
CUSTOMER REPORTS PT INFLAMMATION AFTER USING THIS LOT SUTURE.
INVESTIGATION IN PROGRESS. REFERENCE MFR COMPLAINT #G96-183. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION - LEFT CYLINDER INTO URETHRA AND THE BASE WAS WITH A LARGE DEFECT VIA TUNICA.
TUBING HAD OR DAMAGE. CYLINDER HAD OR DAMAGE. CYLINDER HAD OR DAMAGE. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. PUMP PERFORMED WITHIN SPECIFICATIONS.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FAILURE--PAIN AT PUMP.
A CONSUMER WEARING A PAIR OF CO'S SUNGLASSES WAS STRUCK IN THE RIGHT LENS BY A CATTLE HERDING STICK, OR CANE, WIELDED BY HIS FATHER. THE FATHER SWUNG THE STICK BACK OVER HIS HEAD PREPARATORY TO SWINGING FORWARD. THE TIP OF THE STICK HIT THE RIGHT LENS CAUSING IT TO SHATTER. THE IMPLANT ALSO DEFORMED THE METAL FRAME EYEWIRE. A RESULTANT CUT TO THE RIGHT CHEEK REQUIRED STITCHES TO CLOSE. A LENS PARTICLE BECAME EMBEDDED IN THE UPPER EYELID AND REQUIRED REMOVAL. THE STITCHES HAVE SINCE BEEN REMOVED AND NO FURTHER TREATMENT IS ANTICIPATED.
ALL CO SUNGLASS LENSES ARE CHEMTEMPERED AND 100% FDA DROPBALL TESTED PRIOR TO BEING SOLD. CO STATES ON HANGTAGS FOR GLASSES THAT "LENSES MEET CONN SGSTD40 AND FDA IMPLANT REQUIREMENTS BUT ARE NOT SHATTERPROFF." "DO NOT WEAR FOR NIGHT DRIVING OR AS SAFETY GLASSES." THIS EVENT INVOLVED ONE PERSON.
THE DEVICE WAS USED DURING A SIGMOID COLECTOMY PROCEDURE WITH COLORECTAL ANASTOMOSIS. REPORTEDLY, THE INSTRUMENT FIRED STAPLES BUT DID NOT TRANSECT THE TISSUE. THE ANASTOMOSIS WAS RE-DONE RESULTING IN THE RESECTION OF ADD'L TISSUE.
10/18/96 SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT AND SERIAL NUMBER: 0392Q 006.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD OR DAMAGE.
IT WAS REPORTED TO CO THAT THE DATA FOR A LUNG VENTILATION/PERFUSION STUDY WAS LOST AFTER THE ACQUISITION WAS COMPLETED. THE SITE WAS TRANSFERRING A DIFFERENT DATA SET OVER THE NETWORK DURING THE ACQUISITION. THE CAUSE IS THOUGHT TO BE A NETWORKING ISSUE. THERE IS A CONCERN THAT THIS ISSUE COULD REQUIRE A RESCAN AND DELAY TREATMENT; NO INJURY OR DELAY OF TREATMENT WAS REPORTED.
A CYLINDER WAS REMOVED FROM THE PT, DUE TO FLUID LOSS, AND REPLACED.
THIS EVENT WAS REPORTED AS: THROMBOSIS. NO FURTHER INFO PROVIDED. GRAFT REMAINS IMPLANTED.
ON 5/23/90 DEVICE WAS IMPLANTED. ON 9/24/90 THE RIGHT CYLINDER WAS REVISED. ON 9/13/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--PAIN.
CUSTOMER REPORTS PT INFLAMMATION AFTER USING THIS LOT SUTURES.
INVESTIGATION IS IN PROGRESS. REFERENCE MFR COMPLAINT #G96-185. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE LEFT CYLINDER WAS REMOVED FROM THE PT, DUE TO A LEAK IN CYLINDER-FABRIC TOTALLY DESTROYED, AND REPLACED.
THE DEVICE WAS USED DURING A RIGHT LOBECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON EXPERIENCED DIFFICULTY CLOSING THE INSTRUMENT OVER THE TISSUE AT THE APPLICATION SITE PRIOR TO FIRING. THE TISSUE WAS RESECTED AND THE SURGEON REPAIRED WITH MANUAL SUTURE.
10/18/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFR.
LENS WAS RETURNED COVERED WITH BLOOD AND CLINICAL SOLUTION. LENS WAS EVALUATED AND FOUND TO MEET RELEASE CRITERIA. THIS REPORT WAS MAILED IN TO FDA ON 10/14/96. THIS INFO IS SUBMITTED PURSUANT TO 21CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THIS EVENT WAS REPORTED AS: "LEAKING WITH PULMONARY VENOUS FILLING." NO FURTHER INFO PROVIDED.
ON 2/23/79 DEVICE WAS IMPLANTED. ON 7/23/84 THE CYLINDERS AND PUMP WERE REVISED. ON 10/1/85 AND 7/15/86 THE CYLINDERS WERE REVISED. ON 9/11/96 THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT DUE TO EROSION.
THE PUMP WAS REMOVED FROM THE PT DUE TO EROSION AND INFECTION.
INFO ON AN EXPLANT REPORT STATED THAT THE MFR'S SENSE PACE LEADS WERE CAPPED DUE TO NOISE.
THE CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--WOULD NOT INFLATE.
THE DEVICE WAS USED DURING A GASTROJEJUNOSTOMY DURING A TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE TISSUE WAS NOT TRANSECTED AND THE STAPLES WERE NOT FORMED PROPERLY. THE TISSUE WAS RESECTED AND THE SURGEON REPAIRED WITH ANOTHER DEVICE.
10/18/96 - SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
ALLEGEDLY REVISION SURGERY WAS PERFORMED DUE TO ANTERIOR TIBIAL KNEE PAIN. AT REVISION, ALLEGEDLY BASE WAS LOOSE WITH NO CEMENT ADHERENCE. ALL OTHER COMPONENTS ALLEGEDLY WERE STABLE, WELL FIXED.
CONCLUSION STATEMENT: NO DEVICE FAILURE. THREE ATTEMPTS WERE MADE AND DOCUMENTED REQUESTING MEDWATCH FORM FROM USER FACILITY. NO FORMS WERE RECEIVED.
IMPLANT PLACED 6/28/96. PT EXPERIENCED DISCOMFORT. IMPLANT DID NOT INTERGRATE AND WAS REMOVED 8/11/96. ONE PERSON AFFECTED.
IT IS POSSIBLE THAT THE PT'S AGE IS A FACTOR IN THIS CASE. PERHAPS HER BODY CAN NO LONGER REGENERATE BONE AS READILY AS IT DID WHEN YOUNGER.
DEVICE WAS IMPLANTED ON 3/19/96. THE PUMP WAS REMOVED ON 8/13/96. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 8/28/96 DUE TO INFECTION.
RESERVOIR PERFORMED WITHIN SPECS. CYLINDER HAD OR DAMAGE. CYLINDER HAD OR DAMAGE. TUBING HAD OR DAMAGE.
THIS EVENT WAS REPORTED AS: VALVE EXPLANTED, REASON UNKNOWN. NO FURTHER INFO PROVIDED.
B5: THIS EVENT WAS REPORTED AS PROPHYLACTIC REPLACEMENT AND THEREFORE NOT REPORTABLE.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE-FLUID LOSS AND MECHANICAL DEFECT OF PUMP.
PUMP RESISTOR FLOW RATE NOT WITHIN SPECS.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT RELEASE FROM TISSUE. THE SURGEON INSERTED AN ADD'L PORT AND APPLIED ANOTHER DEVICE ON THE SPECIMEN SIDE. THE ORIGINAL DEVICE WAS RESECTED OFF THE TISSUE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
12/13/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.ADDITIONAL DATA ENTERED IN D9.DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT CHANGING HIS MIND AND REQUESTING A 3-PIECE.
A PT'S HUSBAND REPORTED THAT AFTER THE CYCLER'S SECOND FILL, THE CYCLER FELL ONTO THE FLOOR. THE HUSBAND STATES HE PICKED UP THE CYCLER AND REPLACED IT ON THE STAND. HE STATED THERE WERE NO ALARMS AND HE RESUMED HIS WIFE'S TREATMENT. DURING THE NIGHT THE PT AWOKE COMPLAINING OF SHORTNESS OF BREATH AND ABDOMINAL PAIN. THE PT'S HUSBAND TOOK HER TO THE EMERGENCY ROOM. THE ER PHYSICIAN INFORMED THE PT'S HUSBAND THAT HE HAD DRAINED 8 LITERS OF FLUID FROM THE PT. THE PT'S SYMPTOMS ABATED AND THE PT WAS RELEASED FROM THE ER AND RETURNED HOME. THE OLD CYCLER WAS REPLACED WITH A NEW ONE AND THE PT'S HUSBAND STATES THAT THEY HAVE HAD NO PROBLEMS.
ON 8/2/84 AN AUS DEVICE WAS IMPLANTED. ON 2/21/85 THE CUFF WAS REVISED. ON 9/17/96 THE DEVICE WAS REMOVED FROM THE PT DUE TO CUFF EROSION-URETHRA.
PUMP PERFORMED WITHIN SPECIFICATIONS. BALLOON PRESSURE NOT WITHIN SPCIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. ADD'L LOT AND SERIAL NUMBER: 0048Q 011.
THE SHUNT WAS IMPLANTED IN A 12 YR OLD PT WITH HYDROCEPHALUS ON 8/2/93. ON 9/5/96 THE PT UNDERWENT A SHUNT REVISION SECONDARY TO ACUTE OBSTRUCTION. WHEN THE SHUNT WAS REMOVED IT WAS FOUND THAT IT HAD FRACTURED THROUGHOUT AND MOST OF THE DISTAL END WAS INTO THE PERITONEUM. THE FRACTURE OCCURRED APPROX 2 CM BELOW THE LEVEL OF THE CLAVICLE. THERE IS NOT HISTORY OF TRAUMA OR INJURY TO THE PT.
THE PRODUCT WAS EVALUATED BY CO TENSILE STRENGTH, ULTIMATE ELONGATION AND TUBING DIMENSIONS. THE PERITONEAL CATHETER HAD FRACTURED NEAR THE PROXIMAL END OF THE CATHETER. THE FRACTURED ENDS OF THE CATHETER APPEARED TO HAVE BEEN PARTIALLY WORN AWAY MOST PROBABLY DUE TO ABRASION. THIS THEN PROBABLY LED TO THE REMAINDER OF THE CATHETER WALL TEARING, CAUSING THE BREAK. THE TUBING MET CO SPECS FOR DIMENSIONS, TENSILE STRENGTH, AND ULTIMATE ELONGATION. THE LOT NUMBER REPORTED WAS 9484W. THIS LOT WAS MANUFACTURED IN JULY, 1996. THE PHYSICIAN REPORTED, THAT THE PRODUCT WAS IMPLANTED IN AUGUST, 1993. IF IMPLANTED IN 1993 THE LOT NUMBER OF THE PRODUCT COULD NOT BE 9484W.
DURING A LAPAROSCOPICALLY COLECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE ON THE 3RD FIRING. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THIS EVENT WAS REPORTED AS: LEAKING WITH DETERIORATED, DETACHED, RAGGED LEAFLETS WITH YELLOW ATHEROSCLEROTIC PLAQUE. NO FURTHER INFO WAS PROVIDED.
BLOOD WAS NOTICED IN AND AROUND TUBING, BALLOON WAS TAKEN OUT. NO OTHER IAB WAS NEEDED. PT IS FINE.
H-11 ALL UND INFO REQUESTED BUT NOT REC H-11 SECTION F PROVIDED BY MFR.     H-11 SECTION F PROVIDED BY MFR.
THE DEVICE WAS USED DURING A WEDGE RESECTION PROCEDURE. REPORTEDLY, A COMPLETE FIRING WAS NOT ACHIEVED. THE SURGEON RESECTED ADD'L TISSUE ON THE PT SIDE AND APPLIED ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THE PT HAS RECOVERED. EXPIRATION DATE 10/30/00.
10/18/96 - SUBMISSION OF INITIAL REPORT TO FDA BY MFR. THE HOSP WILL NOT RELEASE THE DEVICE FOR EVALUAITON AT THIS TIME.
THE CUFF AND BALLOON WERE REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO A FLUID LOSS.
HEALTHCARE PROFESSIONAL STATED THE VALVE WAS REMOVED DUE TO ENDOCARDITIS. IMPLANTED FOR APPROXIMATELY 60 MONTHS. PT 70 YEARS OLD.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." NO MEDWATCH FORM WAS RECEIVED FROM THE UF THEREFORE, INFO ON THIS MEDWATCH FORM 3500A WAS COMPLETED BY CO WITH INFO RECEIVED FROM THE HEALTHCARE PROFESSIONAL. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A.  H3 ANALYSIS: THE RIGHT AND LEFT CUSPS ARE VERY STIFF, THE NON-CORONARY CUSP IS STIFF BUT SLIGHTLY FLEXIBLE. TEARS IN THE TUNICA ON THE INFLOW AND IN THE LUNULAE AND FREE MARGINS ON THE OUTFLOW ARE ASSOCIATED WITH VISIBLE MINERALIZATION. A BROWN, VEGETATIVE MATERIAL IS DISPERSED OVER THE INFLOW OF ALL CUSPS, COVERS THE LEFT AND NON-CORONARY CUSPS AND FILLS THE RIGHT CUSP.
ON 9/17/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED, REASON NO INDICATED. ADD'L INFO RECEIVED ON 10/14/96 INDICATES THE ORIGINAL IMPLANT WAS DONE IN 8/96. THE REASON FOR THE REVISION WAS FLUID LOSS--THREE PIN HOLES WERE SEEN IN ONE OF THE CYLINDERS.
PERFUSIONIST NOTICED BLOOD IN TUBING. REMOVED AND DID NOT REPLACE. BALLOON WAS IN PLACE FOR 40 HRS. NO COMPLICATION.
THE DEVICE WAS USED ON THE RECTUM. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED A MINIMAL AMOUNT OF ADD'L TISSUE AND APPLIED ANOTHER DEVICE SUCCESSFULLY. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY. EXPIRATION DATE 7/31/01.
THE MENISCAL BEARING INSERT COMPONENTS OF THE KNEE TIBIAL PROSTHESIS FAILED. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. H.4. DEVICE MANUFACTURE DATE IS UNKNOWN BECAUSE THE MANUFACTURING LOT NUMBER WAS NOT PROVIDED TO CO.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS- RIGHT CYLINDER.
ON 9/17, THE PT, A IDDM, TOOK HER NORMAL EVENING DOSE OF INSULIN AND ATE DINNER AT 7/P. SHORTLY AFTER EATING, SHE BECAME "SHAKY, NOT FEELING RIGHT." A METER READING OF 113 MG/DL WAS OBTAINED. SHE DRANK 1/2 GLASS SODA AND TESTED 20 MINUTES LATER WITH A RESULT OF 112 MG/DL. STILL NOT FEELING WELL, SHE TESTED AGAIN ONE-HALF HOUR LATER, WITH A RESULT OF 189 MG/DL. A NEW VIAL OF STRIPS WAS OPENED AND 4 TESTS WERE TAKEN OVER THE NEXT 20 MINUTES WITH RESULTS OF 114, 117, 157 AND 112 MG/DL. THE PT CALLED THE PARAMEDICS WHO OBTAINED A METER READING (BRAND UNK) OF 320 MG/DL. A COMPARISON WAS PERFORMED MOMENTS LATER WITH THE FOLLOWING RESULTS" PARAMEDIC'S METER, 366 MG/DL, PT'S METER, 117 MG/DL. THE PT WAS TRANSPORTED TO THE HOSP, TREATED WITH IV INSULIN AND RELEASED AT 4:30/A. THE PT REPORTS THAT SHE IS ANEMIC AND THAT HER BLOOD SAMPLE IS OFTEN "FLAT. THE PRODUCT'S INSTRUCTIONS FOR USE STATE THAT LOW HEMATOCRITS AND INSUFFICIENT BLOOD SAMPLES MAY RESULT IN LOWER THAN NORMAL METER READINGS. THE METER WAS IN CALIBRATION ON 9/18, READING 85 VERSUS A RANGE OF 66-89.
CO HAS COMPLETED INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAS NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, INADEQUATE SAMPLE SIZE, LOW PATIENT HEMATOCRIT, OR SOME UNK ANOMALY. AT THIS POINT INVESTIGATION OF THIS MATTER IS CLOSED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION.
DURING A LOW ANTERIOR RESECTION PROCEDURE, THE ANVIL DID NOT TILT AND THE INSTRUMENT DID NOT CUT ON THE PROXIMAL END. THE SURGEON REMOVED THE DEVICE AND COMPLETED THE PROCEDURE BY MANUAL SUTURE.
IT WAS REPORTED TO CO THAT A MALE PT REC'D A SMALL REDDENED AND BLISTERED BURN ON HIS RIGHT ELBOW DURING A MAGNETIC RESONANCE EXAMINATION USING A CTL ARRAY COIL. THE PT REFUSED TREATMENT FOR HIS MINOR INJURY. IT WAS DETERMINED THAT THIS SITE HAD NOT REC'D THE UPGRADED VERSION OF THIS COIL AT THE TIME OF THE INCIDENT. THE SITE NOW HAS THE UPGRADED VERSION OF THE PRODUCT.
A CORONARY STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PT'S PROXIMAL LEFT ANTERIOR DESCENDING ARTERY ON 5/26/95 FOLLOWING A MYOCARDIAL INFARCTION. THE PT WAS DISCHARGED FROM THE HOSP ON 5/31/95. THE PT WAS RE-HOSPITALIZED FOR ANGINA ON 7/14/95. A CORONARY ANGIOGRAPHY REVEALED HAZINESS DISTAL TO THE IMPLANTED STENT WHICH WAS SUGGESTIVE OF THROMBOSIS. THE PT WAS SENT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE RELATIVE TO THE EVENT.
THE INITIAL INFO WAS RECEIVED ON A CORONARY STENT TRAINING FORM ON 9/4/96. ADD'L INFO WAS ASCERTAINED ON 9/12/96 AFTER MULTIPLE TELEPHONE CALLS TO THE STENTING PHYSICIAN'S OFFICE. THIS INFO IS INCLUDED IN SECTION B5. THE USE OF A BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM FOR PTS WITHIN 7 DAYS OF AN ACUTE MYOCARDIAL INFARCTION IS NOT RECOMMENDED.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY TO CLOSE THE RECTUM. A LOW HAND-MADE PURSE STRING HAD TO BE PERFORMED WITH A COLOSTOMY. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY. EXPIRATION DATE 2/29/00.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE - CUFF TOO LARGE.
ON 6/15/76 DEVICE WAS IMPLANTED. ON 6/28/79 THE CYLINDERS AND RESERVOIR WERE REVISED. ON 8/6/96 THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. ADD'L INFO RECEIVED ON 10/14/96 INDICATES FLUID LOSS AND WOULD NOT INFLATE.
THE PT WAS IMPLANTED WITH A SALINE PROSTHESIS ON 12/18/95. ON 6/1/96, THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED PAIN IN HER BREAST, IT WAS LATER NOTED THAT THE DEVICE WAS DEFLATED. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (CO EFFECTIVE DATE, 2/10/92). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21CFR803.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY, MENTOR H/S EXPRESSLY DENIES THAT ANY INFORMATION CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION." SEE PRODUCT EVAL ATTACHED HERETO. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO INFECTION, EROSION, AND NON-FUNCTION.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO CUFF EROSION.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON HAD OR DAMAGE.
AT 10/P ON 9/19, THE PT, AN IDDM, OBTAINED A READING ON HIS METER OF 302 MG/DL. BASED UPON THIS READING, HE ADDED 5U REGULAR INSULIN TO HIS NORMAL EVENING DOSE. HIS WIFE FOUND HIM AT 5/A (9/20) SEMICONSCIOUS AND SWEATY. SHE CALLED THE PARAMEDICS WHO ARRIVED 30 MINUTES LATER. THE PT WAS TESTED ON THE PARAMEDIC'S METER WITH A RESULT OF 30 MG/DL. HE WAS TRANSPORTED TO THE HOSP WHERE A 7/A VENOUS LAB GLUCOSE RESULT OF 50 MG/DL WAS OBTAINED. AT 7:12/A RESULT ON THE PT'S METER WAS 457 MG/DL. THE PT WAS TREATED WITH IV GLUCOSE AND RELEASED AT 9 AM. THE METER WAS IN CALIBRATION ON 9/20, READING 83 VERSUS A RANGE OF 70-96.
CO HAS COMPLETED THE INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNK ANOMALY. AT THIS POINT THE INVESTIGATION OF THIS MATTER IS CLOSED.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE DR REPORTED A POST-OPERATIVE LOW GRADE INFECTION AS THE CAUSE.
86= DEVICE NOT RETURNED TO MFR AND LOT NUMBER IS UNAVAILABLE.
A REVISION SURGERY WAS PERFORMED DUE TO EROSION. NO COMPONENTS WERE REMOVED OR REPLACED.
DEVICE WAS REMOVED FROM THE PT DUE TO A RIGHT CYLINDER RUPTURE. ANOTHER DEVICE WAS IMPLANTED.
IT WAS REPORTED TO CO THAT A PT COMPLAINED OF WARMING AFTER BEING SCANNED ON THE RECENTLY UPGRADED CTL ARRAY COIL. AN EXAMINATION OF THE COIL FOUND A LOOSE DIODE AND OTHER SIGNS OF POOR SOLDERING. THE PT WAS NOT INJURED AND DID NOT REQUIRE MEDICAL TREATMENT.
ADDITIONAL INFORMATION RECEIVED ON 11/4/96 INDICATES THE REASON FOR REMOVAL OF DEVICE WAS FLUID LOSS--UNCERTAIN FROM WHERE-PROBLEM DEVELOPED S/P ANGIOGRAPHY AND CORONARY BYPASS-POSSIBLE INJURY TO TUBING.
ADDITIONAL INFORMATION RECEIVED ON 11/18/96 INDICATES THE DEVICE WOULD NOT INFLATE.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER BRAND DEVICE IMPLANTED DUE TO FLUID LOSS-LEFT CYLINDER.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION."
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS--OPENING ON LEFT WHERE TUBING MEETS CONNECTOR.
A FEMALE DIABETIC PT WAS BROUGHT TO IMMEDIATE CARE FACILITY. DEVICE READING FOR BLOOD GLUCOSE WAS LO. DR PRESCRIBED D50 IV. SUBSEQUENT LAB RESULTS FOR BLOOD GLUCOSE WERE 930MG/DL, TAKEN AT SAME TIME AS DEVICE READING. IV D50 STOPPED, PT TRANSPORTED TO HOSP. HOSP LAB RESULT FOR BLOOD GLUCOSE WAS 1100MG/DL. IV INSULIN ADMINISTERED. NEXT DAY BLOOD GLUCOSE BETWEEN 10-200MG/DL.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT, DUE TO AN ANEURYSM, AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
RPTR HAS IDENTIFIED A TREND WITH BATTERY DOORS ON THE PUMP BECOMING LOOSE, OPENING, AND SUBSEQUENTLY THE BATTERY FALLING OUT. THE PUMP THEN CEASES TO FUNCTION AND THE THERAPY IS INTERRUPTED. RPTR HAS HAD NO PT SERIOUSLY INJURED NOR HAVE THEY HAD A DEATH OCCUR AS A RESULT OF THIS PRODUCT DEFECT.
DEVICE WAS REMOVED FROM THE PT DUE TO AUTO INFLATION AND DEFLATION-PUMP VALVE. ANOTHER DEVICE WAS IMPLANTED.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED AT PT'S REQUEST, DUE TO THE FAILED DEIVCE.
AN ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S COMMON ILIAC ARTERY. UPON THE INITIAL INFLATION ATTEMPT, THE BALLOON BURST AT 3 ATM PRESSURE. THE STENT WAS SURGICALLY RETRIEVED. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. EXPIRATION DATE: 9/30/2000.
THE BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT DUE TO DISTAL EROSION.
DURING SVC OF PRODUCT DEVICE WAS FOUND TO NOT CYCLE WITH ALL LEDS AND CONSTANT SINGLE TONE ALARM , DUE TO INTEGRATED CIRCUITS U24 AND U28 ON THE LOGIC BOARD AND U10 ON THE MOTOR BOARD BEING OUT OF SPEC. REPLACED U24, U28 AND U10.
ADDI'L MFR NARRATIVE AND OR NA . CORRECTED DATA NA.
THE PROBLEM WAS OBSERVED ON 10/7/96. WHILE SOLUTION WAS RUNNING THROUGH THE FILTER TO THE PT, IT BECAME UNHOOKED. TWO DIFFERENT NURSES, THREE DIFFERENT PTS WERE FACED WITH THIS PROBLEM.
DOCTOR REPORTS HE HAS EXPERIENCED WOUND LEAKAGE AND HAS HAD TO ADD STITCHES AS A RESULT OF PRODUCT DESIGN CHANGES.
NO ADD'L INFO HAS BEEN RECEIVED DESPITE REQUEST. NO SAMPLE OR LOT INFO WAS PROVIDED FOR EVALUATION. NUMBER OF PERSONS AFFECTED = 1. THIS REPORT WAS MAILED TO FDA ON: 10/18/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE RPEORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN CO PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
REPORTER ADMINISTRATOR AT OUTPATIENT FACILITY REPORTS GETTING BLOOD GLUCOSE READING OF 43 ON DEVICE AND STARTING IV GLUCOSE. LAB RESULTS WERE 1672 MG/DL. THREE OTHER RESULTS ON DEVICE YIELDED "MG/DL" MESSAGE, WHICH INDICATES RESULT FOR BLOOD GLUCOSE ABOVE 600 MG/DL. PT TREATMENT WITH GLUCOSE STOPPED AND SWITCHED TO INSULIN, WITH SUBSEQUENT TRANSFER TO EMERGENCY ROOM. NO OTHER PT INFO GIVEN. DEVICE WAS INSERVICED FOR FIRST TIME DURING THIS INCIDENT, PER COMMENT FROM POC ADMINISTRATOR.
RPTR HAS IDENTIFIED A TREND WITH BATTERY DOORS ON THE PUMP BECOMING LOOSE, OPENING, AND SUBSEQUENTLY THE BATTERY FALLING OUT. THE PUMP THEN CEASES TO FUNCTION AND THE THERAPY IS INTERRUPTED. RPTR HAS NO PT SERIOUSLY INJURED NOR HAVE THEY HAD A DEATH OCCUR AS A RESULT OF THIS PRODUCT DEFECT.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORT #M721351.
ON 6/19/96 DEVICE WAS IMPLANTED. ON 9/11/96 ADDED REAR TIP EXTENDERS TO CORRECT SST DEFORMITY.
DOCTOR REPORTS HE HAS EXPERIENCED WOUND LEAKAGE AND IRIS PROLAPSE AS A RESULT OF THE NEW BLADE DESIGN.
NO ADDITIONAL INFO HAS BEEN RECEIVED DESPITE REQUEST. NO SAMPLE OR LOT CODE INFO WAS PROVIDED FOR EVALUATION. NUMBER OF PERSONS AFFECTED = 1. THIS REPORT WAS MAILED IN TO FDA ON: 10/18/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN CO PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE HUB CONNECTOR DISTORTED. COULD NOT ATTACH THE DELIVERY SYSTEM. THE INTRODUCER WAS REMOVED FROM THE PT AND A FILTER WAS SUCCESSFUL IN COMPLETING THE PROCEDURE (NO OTHER CO FILTERS WERE AVAILABLE).
THE HUB CONNECTOR DISTORTED. THE USER WAS UNABLE TO ATTACH THE DELIVERY SYSTEM. THE INTRODUCER WAS REMOVED FROM THE PT AND ANOTHER CO'S FILTER WAS USED TO COMPLETE THE PROCEDURE.MALE PROTUSION BETWEEN Y-ADAPTER BODY AND ROTATING MALE LUER/O-RING WAS BENT OFF-CENTER. THE MALE LUER/O-RING BECAME SEPARATED FROM THE Y-ADAPTER BODY. FILTER WAS NOT PRESENT IN RETURNED SAMPLE. DEVICE HISTORY RECORD REVIEW FOUND THAT THE INCOMING LOT NUMBERS WERE 114066T AND 1270661. THE FINISHED LOTS MADE WITH Y-ADAPTERS OF THOSE LOTS ARE 518066C, 527066B, 530076C, AND 502086A. DEVICE HISTORY REVIEW CONFIRMED THAT THIS COMPONENT WAS SUBJECTED TO AND SATISFIED ALL CURRENT QUALITY STANDARDS SPECIFIC IN THE APPLICABLE DEVICE MASTER RECORD. LOT WAS MANUFACTURED ON 7/16/96."USE BY " DATE IS JULY 1999. THE MALE LUER OF THE Y-ADAPTER HUB CONNECTOR WAS BENT.
DURING SVC OF PRODUCT A LOW VOLUME AUDIBLE ALARM WAS FOUND AT POWER UP DUE TO ALARM COMPONENT BEING AT OF SPEC. REPLACED ALARM.
ADD'L MFR NARRATIVE AND / OR NA. CORRECTED DATA NA.
METHOD (86): PART NOT RETURND. LOT NUMBER NOT AVAILABLE FROM DR.
ON 1/14/91 DEVICE WAS IMPLANTED. INFO RECEIVED ON 9/17/96 INDICATES THE ENTIRE DEVICE WAS REMOVED FROM THE PT ABOUT TWO YEARS AGO DUE TO EROSION. DATE OF SURGERY WAS NOT PROVIDED.
A CYLINDER WAS REMOVED FROM THE PT DUE TO EXTRUSION AND PT DISCOMFORT--PAIN.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, THE SUTURE BROKE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -INPUT TUBING.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTORY-SST DEFORMITY.
DURING SVC OF PRODUCT AN INTERMITTENT APNEA ALARM WAS FOUND DUE TO AN OUT OF CALIBRATION CONDITION. DEVICE RECALIBRATED.
AN ABUTMENT WAS LOOSE AND HE ELECTED TO CUT IT OFF TO REMOVE IT. PT IS REPORTEDLY FINE.
MEASUREMENTS COULD NOT BE TAKEN SINCE ONLY THE SCREW WAS RETURNED. A FUNCTIONAL INSPECTION OF THE RETURNED SCREW FOUND THE SCREW TO STILL BE FUNCTIONAL. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE MD.
EMT'S ATTENDED TO A PT IN CARDIAC ARREST. ALLEGEDLY WHEN THE DEFIBRILLATOR WAS TURNED ON, IT SPONTANEOUSLY SHUT OFF. A SECOND BATTERY WAS THEN USED AND THE UNIT WAS CHARGED. REPORTEDLY THE UNIT REACHED CHARGE THEN SHUT OFF AGAIN BEFORE DEFIBRILLATION THERAPY COULD BE DELIVERED TO THE PT. ANOTHER DEFIBRILLATOR AT THE SCENE WAS THEN IMMEDIATELY USED TO DELIVER DEFIBRILLATION THERAPY TO THE PT. THE PT WAS NOT CONVERTED. PARAMEDICS THEN ARRIVED AND PT WAS TRANSPORTED TO THE HOSP. THE PT WAS NOT RESUSCITATED.
CO TESTED THE UNIT AND FOUND IT TO OPERATE NORMALLY DURING PERFORMANCE AND FUNCTIONAL TESTING. WITH THE OPERATOR OBSERVING, THE CO SERVICE REP SIMULATED A DEPLETED BATTERY FAILURE. THE OPERATOR INDICATED THAT THE DEVICE ACTED SIMILARLY DURING THE ALLEGED MALFUNCTION. THE BATTERIES USED DURING THE INCIDENT HAD BEEN REDISTRIBUTED FOR USE AND WERE NOT AVAILABLE FOR ANALYSIS. THE FACILITY'S BATTERY INVENTORY WAS REPLACED AND PROPER BATTERY MAINTENANCE PROCEDURES WERE REVIEWED.
DEVICE WAS REMOVED FROM THE PT AN ANOTHER DEVICE IMPLANTED DUE TO MALFUNCTION.
PT ADMITTED FOR DIAGNOSTIC PROCEDURE AND POSSIBLE PTCA. LESION IDENTIFIED IN LAD AND PTCA PROCEDURE WAS INITIATED WITH CATHETER. WIRE WAS LOADED INTO CATHETER AND ADVANCED INTO GUIDE TOWARDS LESION. WHEN ATTEMPTING TO PLACE WIRE INTO LESION, WIRE COULD NOT BE ADVANCED THROUGH CATHETER. UNIT KINKED DURING MANIPULATION. DR ADVANCED BOTH THE CATHETER AND IMMOBILIZED WIRE INTO LESION. BALLOON WAS INFLATED TO 6 ATM AND DEFLATED.
SECTION A 5 CONTINUED: A DISSECTION WAS NOTED AND THE DR ATTEMPTED TO WITHDRAW BALLOON. THE IMMOBILIZED WIRE PREVENTED REMOVAL OF CATHETER. DR PLACED 2ND WIRE ALONG SIDE BALLOON WHILE ATTEMPTING TO EXCHANGE WIRES. WIRE KEPT TRACKING OUTSIDE OF VESSEL DUE TO FALSE LUMEN AND MADE DISSECTION WORSE. PT SUFFERED MAJOR MYOCARDIAL INFARCTION DURING PROCEDURE AND WAS TAKEN TO SURGERY. PT RECOVERED AND HAS BEEN SENT HOME IN GOOD SPIRITS, BUT QUALITY OF LIFE HAS DECLINED. H.6: RESULTS CODE #400 "OTHER": USED TO CLASSIFY PRODUCT COMPONENT AS "GUIDEWIRE LUMEN". EVALUATION SUMMARY OF RETURNED PRODUCT: FAILURE ANALYSIS FINDINGS AND THE CUSTOMER'S REPORT INDICATED THE EXCESSIVE DAMAGE TO THE CATHETER WAS THE RESULT OF MANIPULATION AND REMOVAL OF THE IMMOBILIZED GUIDEWIRE. DUE TO THE FOLLOWING CONDITIONS, CO COULD NOT DETERMINE THE INITIAL CAUSE OF THE WIRE IMMOBILIZATION: THE USER STATED THE CATHETER WAS DAMAGED DURING WIRE REMOVAL; THE USER HAD FLUSHED THE UNIT OF ANY DRIED FLUIDS TO CONTAMINANTS; AND THE WIRE WAS NOT AVAILABLE FOR INSPECTION. THE INSTRUCTIONS FOR USE STATE "IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING". PRODUCT SHOULD NOT HAVE BEEN USED AFTER THE  WIRE IMMOBILIZATION WAS IDENTIFIED. THE CUSTOMER WAS INFORMED OF EVALUATION RESULTS. NO OTHER CORRECTIVE ACTION REQUIRED AT THIS TIME. :
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDERS. ADD'L LOT AND SERIAL NUMBER: 1840Q 001.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CYLINDER HAD A FATIGUE LEAK. TUBING WAS FUNCTIONAL.
ADDITIONAL INFO RECEIVED ON 8/5/97 INDICATES THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED ON 7/4/97 DUE TO RECURRING INCONTINENCE.
REPORT OF ALLEGED SINGLE TONE ALARM, ALL LEDS ON, STOPPED CYCLING. FOUND DURING BENCH TEST".
TESTING BY MFR DEVICE WOULD NOT CYCLE, WITH ALL LEDS AND CONSTANT SINGLE TOME AUDIABLE ALARM, DUCT OT INTERATED CIRCUIT V 28 ON THE LOGIC ABOARD BEING OUT OF SPECIFICATION. REPLACED V 28.
MEDICS ARRIVED TO FIND A MALE PT IN HIS 60'S WHO WAS EXPERIENCING A CARDIAC ARREST. THE PT HAD AN EXTENSIVE HISTORY OF CARDIAC PROBLEMS. THEY ATTACHED A UNIT TO THE PT USING A MULTI-FUNCTION CABLE AND DEVICE. THE MEDICS ATTEMPTED TO MONITOR THE PT, BUT THE UNIT'S MONITOR SCREEN DISPLAYED A DOTTED LINE FOR AN ECG TRACE AND A "CHECK ELECTRODES" MESSAGE. THE MEDIC'S SWITCHED SETS OF DEVICE TWICE AND WERE ABLE TO OBTAIN AN ECG TRACE. THE MEDICS DETERMINED THAT THE PT'S RHYTHM WAS IN ASYSTOLE. THEY ADMINISTERED TWO ROUNDS OF ACLS, BUT THE PT'S CONDITION DID NOT IMPROVE. THE PT DID NOT SURVIVE THE CODE. THE COMPLAINANT INDICATED THAT THE ALLEGED MALFUNCTION DID NOT CONTRIBUTE TO THE PT OUTCOME.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO STRESS URINARY INCONTINENCE AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS. ORIGINAL BALLOON PRESSURE UNDETERMINABLE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR.
GREASE APPEARS TO BE LOCATED ON IV TUBING SPIKE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED WITH A COMPLETE DEVICE AND TANDEM CUFF DUE TO FLUID LOSS-TUBING FRACTURE. ADD'L LOT AND SERIAL NUMBER: 7219L 010.
PUMP/TUBING JUNCTION HAD A FATIGUE LEAK. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. THE SUTURE BROKE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
A CORONARY STENT WAS SUCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY. PRIOR TO DISCHARGE FROM THE CARDIAC CATH LAB, THE PT HAD A CARDIAC ARREST AND SUBSEQUENTLY EXPIRED. THE PHYSICIAN ATTRIBUTED THE DEATH TO CORONARY OCCLUSION AT AN UNK LOCATION. THEREFORE, THE ROLE OF THE STENT AND THE STENTING PROCEDURE REMAINS UNCLEAR IN THE EVENT.
THE PUMP WAS RELOCATED DUE TO PT DISSATISFACTION--SWELLING ON THE RIGHT SIDE OF THE SCROTUM DUE TO PREVIOUS HERNIA REPAIR CONCOMITTANTLY.
ON 5/14/91 AN AUS DEVICE WAS IMPLANTED. ON 6/29/93 THE CUFF WAS REVISED. ON 12/14/93 THE BALLOON AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO  RECURRING INCONTINENCE.
ON 8/22/95 DEVICE WAS IMPLANTED. ON 10/25/95 THE PUMP WAS REVISED. ON 9/11/96 THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACTION - SEEMED TO DEFLATE SPONTANEOUSLY, CAPSULE AROUND RESERVOIR. SOME ANGULATION OF THE PENIS AND SOME DISCOMFORT IN THE SCROTUM.
A CORONARY STENT WAS SUCCESSFULLY DEPLOYED AT THE CALCIFIED TARGET LESION SITE IN THE PT'S LEFT ANTERIOR DESCENDING ARTERY. A SECOND CORONARY STENT WHICH WAS UNSHEATHED, WAS ADVANCED TO THE CALCIFIED TARGET LESION SITE. THE PHYSICIAN WAS UNABLE TO FULLY DEPLOY THE STENT. FOUR BALLOON CATHETERS WERE INTRODUCED IN ATTEMPT TO FULLY EXPAND THE STENT. THE PHYSICIAN INDICATED THAT THE STENT HAD BEEN DAMAGED BY CONTACT WITH THE CALCIFIED LESION. THE PT WAS SENT FOR EMERGENT CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE INITIAL INFO WAS RECEIVED ON A MEDICAL DEVICE REGISTRATION FORM ON 8/15/96. NUMEROUS ATTEMPTS TO OBTAIN ADD'L INFO BETWEEN 8/20/96 AND 9/11/96 WERE UNSUCCESSFUL. THE STENTING PHYSICIAN WAS REACHED BY TELEPHONE ON 9/16/96 AND PROVIDED THE INFO INCLUDED IN SECTION B5. CO RECOMMENDS THAT THE SDS SHEATH BE MAINTAINED OVER THE BALLOON AND STENT ASSEMBLY UNTIL POSITIONED FOR STENT DEPLOYMENT.
DENTAL ASSISTANT REPORTED THAT FOUR YRS POST RESTORATION, THE IMPLANT WAS REMOVED DUE TO DEHISCENCE AND INFECTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS MDR REPORT #M750100 AND MEDWATCH REPORT #2023141-1996-00170.
THE CONNECTOR WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CONNECTOR FRACTURE.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT WOULD NOT OPEN AFTER FIRING. THE SURGEON MANUALLY MANIPULATED THE DEVICE OFF THE TISSUE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/16/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFR.
ON 4/8/92 AN AUS DEVICE WAS IMPLANTED. ON 9/17/96 A TANDEM CUFF WAS IMPLANTED DUE TO RECURRING INCONTINENCE. NO COMPONENTS WERE REMOVED OR REPLACED.
DURING A LOW ANTERIOR RESECTION PROCEDURE, THE INSTRUMENT WAS DIFFICULT TO CLOSE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE.
12/05/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9, E1 AND F5. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
ON 5/3/91 DEVICE WAS IMPLANTED. ON 8/15/96 THE PUMP AND RESERVOIR WERE REVISED. ON 9/6/96 THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT DUE TO INFECTION. ADD'L INFO RECEIVED ON 10/8/96 INDICATES ONLY THE PUMP WAS REMOVED ON 9/6/96.
SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY, CO EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRBIUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO. ON 5/2/88 THE PHYSICIAN NOTED THAT THE PT DEVELOPED AUTO-IMMUNE SYMPTOMS, PAIN AND CAPSULAR CONTRACTURE IN BOTH BREASTS. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. THE PT WAS BILATERALLY IMPLANTED WITH COMBINATION GEL/SALINE PROSTHESIS ON 12/2/87. ON 5/2/88 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AUTO-IMMUNE SYMPTOMS, PAIN AND CAPSULAR CONTARCTURE IN BOTH BREASTS. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
DENTAL ASSISTANT REPORTED THAT FOUR YRS POST-RESTORATION TWO IMPLANTS WERE REMOVED DUE TO DEHISCENCE AND INFECTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORT #M750100 AND MEDWATCH REPORT #2023141-1996-00169.
DURING A LOW ANTERIOR RESECTION PROCEDURE, THE INSTRUMENT WAS DIFFICULT TO REMOVE. THE HOSP HAS REPORTED NO FURTHER INFO.
11/22/96- SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADD'L DATA ENTERED IN D9. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6.
AN IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION.
A PRE-MOUNTED CORONARY STENT WAS REMOVED FROM THE DELIVERY SYSTEM AND REMOUNTED ON AN ALTERNATIVE BALLOON CATHETER. DURING AN ATTEMPT TO ADVANCE THE CORONARY TO THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY, THE STENT EMBOLIZED TO THE REGION OF THE AORTIC VALVE. THE PT WAS SENT FOR EMERGENT CORONARY ARTERY BYPASS GRAFT SURGERY. THE STENT WAS NOT RECOVERED DURING SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE INITIAL INFO WAS RECEIVED ON A MEDICAL DEVICE REGISTRATION FORM ON 8/23/96. STARTING ON 8/26/96 NUMEROUS ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO VIA THE TELEPHONE WITH THE STENTING PHYSICIAN'S OFFICE. THE PHYSICIAN WAS ON VACATION FOR TWO WEEKS. THEREFORE, ADD'L INFO WAS NOT PROVIDED TO CO BY THE STENTING PHYSICIAN, UNTIL 9/12/96. THIS INFO IS INCLUDED IN SECTION B5. CO DOES NOT RECOMMEND RE-MOUNTING THE BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEN ON ANOTHER BALLOON CATHETER.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND POLYETHYLENE WEAR AND DISASSOCIATION OF THE PATELLA.
SUMMARY OF EVAL: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AND PATELLA DISASSOCIATION AS THEY HAVE NOT BEEN RETURNED TO CO BUT RATHER HAVE BEEN DISCARDED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENT IS NOT POSSIBLE AS THE LOT CODES HAVE NOT BEEN UNSUCCESSFUL. THE MEDICAL OPINION SUGGESTS THAT THIS EVENT IS ASSOCIATED WITH PT WEIGHT AND TIME.
DURING A LOW ANTERIOR RESECTION PROCEDURE, THE INSTRUMENT WAS DIFFICULT TO OPEN. THE HOSP HAS REPORTED NO FURTHER INFO.
12/05/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
A SCREW BROKE IN FUNCTION. PT WASN'T AWARE SCREW WAS BROKEN UNTIL OFFICE VISIT. PT IS REPORTEDLY FINE.
METHOD(86): PART NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM DR.
ON 11/1/89 AN AUS DEVICE WAS IMPLANTED. ON 8/28/92 THE CUFF WAS REVISED. ON 11/22/95 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
PT DEVELOPED LOOSENING OF RIGHT KNEE PROSTHESIS PLACED IN 1985 RESULTING IN SURGICAL REPLACEMENT.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-000174.
A PREMOUNTED CORONARY STENT WAS REMOVED FROM THE SDS AND REMOUNTED ON ANOTHER MFR'S BALLOON CATHETER. DURING ADVANCEMENT ATTEMPT TO THE TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY, THE STENT DISLODGED FROM THE BALLOON CATHETER AND MIGRATED PROXIMALLY ALONG THE GUIDEWIRE. THE DISLODGED STENT WAS RETRIEVED UTILIZING A SNARE WIRE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
IT IS NOT RECOMMENDED THAT THE BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM BE REMOVED FROM THE PREMOUNTED DELIVERY BALLOON CATHETER AND REMOUNTED ON ANOTHER MFR'S BALLOON CATHETER.
SUMMARY OF EVAL: THE DEVICE CAN NOT BE EVALUATED FOR THE REPORTED LOOSENING AS IT HAS NOT BEEN RETURNED TO CO. THE CATALOG NUMBER AND LOT CODE HAVE NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE, CATALOG NUMBER AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL.
17.5 DIOPTER POSTERIOR CHAMBER INTRAOCULAR LENS WAS IMPLANTED ON 7/11/96. POST-OPERATIVE VISION WAS NOT SATISFACTORY; THE FIRST LENS WAS REMOVED ON 8/8/96. DURING THIS SECONDARY SURGERY, THE PHYSICIAN IMPLANTED A 22.5 DIOPTER REPLACEMENT LENS.
THE LENS WAS RECEIVED IN AN INJECTION MOLDED LENS TRAY (I 1) AND (#3) CAP. TRACES OF SOLUTION AND DRIED BLOOD WERE NOTED ON THE CAP AND TRAY. LIGHT SMUDGES OF SURGICAL SOLUTION, A HINT OF DRIED BLOOD AND FIBERS WERE NOTED ON THE LARGE AND SMALL CONVEX ALONG WITH TWO SCRATCHES ON THE LARGE CONVEX. ONE LOOP WAS SEVERELY PINCHED AT THE OPTIC EDGE CAUSING IT TO PULL SLIGHTLY INWARDS. THE OTHER LOOP WAS KINKED AT THE OPTIC EDGE AND THEN PINCHED CAUSING IT TO BEND INWARDS. THE OPTIC WAS ACCEPTABLE, HOWEVER, BOTH LOOPS WERE EXTREMELY SHORT DUE TO THE PINCHED AND KINKED AREAS. UNABLE TO CHECK THE VAULT DUE TO THE CONDITION OF BOTH LOOPS. DIOPTER: 17.40 = 17.5 ACCEPTABLE. GENERAL RESULTS/OBSERVATIONS: THIS 17.5 DIOPTER LENS WAS IMPLANTED ON 7/11/96 AND EXPLANTED ON 8/8/96. A REPLACEMENT LENS WITH A DIOPTER OF 22.5 WAS IMPLANTED AT THIS TIME. APPARENTLY THE PT HAD TROUBLE SEEING WITH THE ORIGINAL LENS. UPON RECEIPT FROM THE DOCTOR, THE EXPLANTED LENS WAS CLEANED AND DIOPTERED SEVERAL TIMES. ALL READINGS INDICATED THAT THIS LENS DOES HAVE A DIOPTER OF 17.5 AND WAS NOT MISLABELED. APPARENTLY THE DOCTOR DID NOT CALCULATE THE PT'S REQUIRED POWER CORRECTLY THE FIRST TIME.
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-000173.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO DEFECTIVE IMPLANT.
PUMP PERFORMED WITHIN SPECIFICTIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE AND WEAR LEAK. CYLINDER HAD TORN AND BULGING. TUBING HAD OR DAMAGE.
A PT SWALLOWED HER RESTORATION WHILE EATING, BUT DID NOT REALIZE IT UNTIL LATER. THE RESTORATION HAS BEEN REMOVED AND THE PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITHT THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOG HISTORY OF THE SUBJECT PRODUCT WAS FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
AN AUS DEVICE WAS IMPLANTED ON 2/15/91. THE PUMP AND BALLOON WERE REVISED ON 4/14/93. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 5/15/96, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
DEVICE WAS REMOVED FROM THE PT DUE TO AN "UNSPECIFIED MALFUNCTION." ADD'L LOT NUMBER: 1216T 015. ADD'L SERIAL NUMBER: 1216T 015.
REVISION SURGERY REVEALED LOOSENING OF THE FEMORAL STEM.
SUMMARY OF EVAL: THE DEVICE HAS NOT BEEN RETURNED TO CO, AS THE PT REQUESTED TO KEEP THE IMPLANT. REQUESTS TO OBTAIN THE DEVICE AND DEVICE LOT CODES WAS UNSUCCESSFUL. AN EVALUATION OF THIS EVENT CANNOT BE PERFORMED, AND THE INFO PROVIDED IS INSUFFICIENT TO DETERMINE THE CAUSE FOR THIS EVENT.
REPORT OF ALLEGED CONSTANT SINGLE TONE ALARM, ALL LEDS ON, MACHINE NOT CYCLING.
ADD'L TESTING BY MFR FOUND DEVICE WOULD NOT CYCLE, WITH ALL LEDS AND CONSTANT SINGLE TONE ALARM, DUE TO A INTERMITTENT ELECTRICAL CONNECTION.
THE DEVICE WAS APPLIED DURING A ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE TISSUE WAS NOT CUT AND STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE STAPLE LINE AND COMPLETED THE PROCEDURE MANUALLY. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
12/29/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. DEVICE NOT AVAILABLE FOR EVAL.
NO OBSERVABLE DEFECT COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE MD.
PARTICULATE APPEARED DURING A CATARACT EXTRACTION PROCEDURE IN WHICH DR WAS USING THIS PHACOEMULSIFICATION HANDPIECE. NOT ALL OF THE PARTICULATE WAS ABLE TO BE ASPIRATED.
ADD'L INFO RECEIVED FROM CONTACT ON 11/22/96 INDICATES THAT THIS PT HAS 20/20 VISION AND IS HAVING NO PROBLEMS. THE PARTICULATE IS STILL VISIBLE ON THE IRIS.
DISTRIBUTOR WAS INFORMED ON AN EXPLANT REPORT THAT THE MFR'S SENSE PACE LEADS WERE REPLACED DUE TO NOISE. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORM TO SPEC. TO DATE, 9/19/96, THE LEADS HAVE NOT BEEN RETURNED TO DISTRIBUTOR AND THERE WAS NO INDICATION WHETHER THE LEADS WERE EXPLANTED OR CAPPED.
THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OF CULPABILITY FOR ANY AND/OR ALL ASPECTS OF THIS EVENT, AND MAY BE BASED UPON INCOMPLETE AND OR UNSUBSTANTIATED INFO.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION -LEFT CYLINDER AND FLUID LOSS. ADD'L SERIAL NUMBER: 5408K 015. ADD'L LOT NUMBER: 5408K 018.
RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVALUATION: THE TIBIAL COMPONENT CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS IT HAS NOT BEEN RETURNED TO THE MFR BUT RATHER HAS BEEN DISCARDED AT THE HOSP FACILITY. THE LOT CODE HAS NOT BEEN SUPPLIED, NOR IS IT INCLUDED IN THE MEDICAL RECORDS WHICH WERE PROVIDED TO THE MFR. THE MEDICAL OPINION WAS THAT THE WEAR WAS DUE TO THE 12 YEAR IMPLANTATION TIME, THICKNESS OF THE INSERT, AND THE PT'S WEIGHT.
THE BALLOON WAS REMOVED FROM THE PT, DUE TO RECURRING INCONTINENCE, AND REPLACED.
THE DEVICE WAS APPLIED DURING A ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE ORIGINAL STAPLE LINE AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
11/20/96-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6.
AT UNCOVERY AN IMPLANT HAD FAILED TO INTEGRATE. PT IS REPORTEDLY FINE.
THIS EYE SPECULUM BROKE AT THE BLADE DURING A PRK PROCEDURE. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.
SECTION A-F WERE COMPLETED BY THE MFR. CAUSE FOR BREAKAGE IS NOT KNOWN; HOWEVER THE DEVICE COULD HAVE BEEN CLEANED IN TOO STRONG OF A SOLUTION THAT DETERIORATED THE BRAZING.
ON 1/11/80 DEVICE WAS IMPLANTED. ON 2/14/83 THE CYLINDERS AND RESERVOIR WERE REVISED. ON 9/13/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
THE AUS DEVICE WAS REMOVED FROM THE PT, DUE TO RECURRING INCONTINENCE, AND REPLACED.
PUMP WAS NOT FUNCTIONALLY TESTED. CUFF PERFORMED WITHIN SPECS. BALLOON HAD A WEAR LEAK.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -LEFT CYLINDER HOLE. ADD'L SERIAL NUMBER: 5440J 012. ADD'L LOT NUMBER: 5440J 012.
ACCOUNT (END USER) REPORTED RECEIVING ONE UNIT OF A CUSTOM KIT WITH A HOLE IN THE TYVEK PORTION OF THE POUCH. THE KIT WAS NOT USED.
FROM THE CONDITION OF THE KIT POUCH (DIRTY, YELLOWING), IT WAS DETERMINED THAT THE SHIPPING AND OR STORAGE OF THE KIT CAUSED THE CONDITION NOTED BY THE CUSTOMER. THE END USER HOSPITAL'S KIT DISTRIBUTOR HAS BEEN NOTIFIED TO BE ALERT FOR CONDITIONS WHICH COULD EFFECT THE INTEGRITY OF THE KIT POUCHES. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF NAMIC USA CORP. THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
TWO ABUTMENTS BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORTS #M494295 AND M547854.
THE ORIGINAL DATE THE CATHETER WAS IMPLANTED WAS IN JULY OF 1996. THE PT EXPEREINCED PAIN SEVERAL WEEKS POST-OPERATIVELY. THE SURGEON PERFORMED A RE-OPERATION AND DISCOVERED THE CATHETER WAS SLICED. A NEW CATHETER WAS INSERTED AT THAT TIME. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
10/17/96: MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
SUMMARY OF EVAL: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AND PATELLA DISASSOCIATION AS THEY HAVE NOT BEEN RETURNED TO CO BUT RATHER HAVE BEEN DISCARDED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENT IS NOT POSSIBLE AS THE LOT CODES HAVE NOT BEEN PROVIDED. ATTEMPTS TO OBTAIN LOT CODE INFO HAVE BEEN UNSUCCESSFUL. THE MEDICAL OPINION SUGGESTS THAT THIS EVENT IS ASSOCIATED WITH PT WEIGHT AND TIME.
THE DOOR OF THE STERILIZER CAME OPEN DURING THE CYCLE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -RESERVOIR WAS EMPTY. ADD'L SERIAL NUMBER: 1358K 012. ADD'L LOT NUMBER: 1358K 012.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. TUBING HAD OR DAMAGE.
REVISION SURGERY WAS PERFORMED FIVE MONTHS POST ORIGINAL IMPLANTATION. REPORTEDLY, THE PT HAD EXPERIENCED RECURRENT DISLOCATIONS. REVISION SURGERY WAS PERFORMED AND THE ATTENDING PHYSICIAN REPORTEDLY MODIFIED THE SUBJECT DEVICE ANTERIORLY TO REDUCE IMPINGEMENT WITH THE FEMORAL STEM'S NECK.  THE PHYSICIAN DECIDED TO MODIFY THE DEVICE IN SITU SINCE IT WAS WELL FIXED WITHIN THE ACETABULAR CAVITY.
F10 DEVICE CODE "OTHER" 2203 - IMPINGEMENT DEVICE MODIFIED BY PHYSICIAN IN SITU. H6 METHOD CODE "OTHER" 86 - RADIOGRAPHS REVEIWED. ACTUAL DEVICE'S MFG HISTORY RECORDS REVEIWED. RESULTS CODE "OTHER" 200 - ORIGINAL IMPLANT-POSITIONING. IMPINGEMENT. THE REPORTED EVENT WAS ORIGNALLY RECEIVED FROM THE IDENTIFIED HEALTH CARE PROFESSIONAL (PHYSICIAN) NO THE UF OR A DIST. BASED ON THIS, SECTION F OF THE MED-REPORT WAS FILLED OUT BY THE MFR. CO'S FOLLOW-UP WITH THE ATTENDING PHYSICIAN AND REVIEWED OF THE PT'S RADIOGRAPHS DISCOVERED THE IDENTIFIED DEVICE WAS SURGICALLY MODIFIED AS TREATMENT FOR RECURRENT SUBLUXATIONS AFTER AN IMPLANTATION PERIOD OF FIVE MONTHS. THE SUBJECT DEVICE WAS ORGINALLY IMPLANTED DURING A ROUTINE THR REVISION CASE ON APRIL 10, 1996. SINCE THIS TIME THE PT WAS REPORTED TO HAVE EXPIERIENCED RECURRENT DISLOCATIONS OF THE INVLOVED JOINT. A REVISION SURGERY WAS PERFORMED AND THE ATTENDING PHYSICIAN REPORTED THAT THE IDENTIFIED DEVICE WAS IMPINGING AGAINST THE FEMORAL HIP STEM ON THE ANTERIOR SIDE. IT IS FURTHER REPORTED THAT SINCE THE IDENTIFIED DEVICE WAS WELL FIXED IN THE ACETABULAR CAVITY THE SURGEON ELECTED TO MODIFY THE DEVICE IN SITU BY CUTTING DOWN THE ANTEROIR LIP. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE CURRENT PACKAGE INSERT STATES, IN PERTINENT PART "DISLOCATION OF THE HIP PROSTHESIS CAN OCCUR DUE TO INAPPROPRIATE PT ACTIVITY, TRAUMA OR OTHER BIOMECHANICAL CONSIDERATIONS". THE PACKAGE INSERT CONTINUES BY STATING, "APPROPRIATE SELECTION, PLACEMENT AND FIXATION OF THE FEMORAL STEM AND/OR ACETABULAR COMPONENTS ARE CRITICAL FACTORS WHICH AFFECT IMPLANT SERVICE LIFE." FINALLY, "ADVERSE EFFECTS MAY NECESSITATE REOPERATION, REVISION, ARTHRODESIS OF THE INVOLVED JOINT, GIRDLESTONE OR AMPUTATION OF THE LIMB." DISCLAIMER: SUBMISSION OF INFO BY OSTEONICS UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THIS REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER FOIA.
REVISION REVEALED BREAKAGE OF THE TIBIAL BASEPLATE.
SUMMARY OF EVAL: THE TIBIAL BASEPLATE CANNOT BE EVALUATED FOR THE REPORTED BREAKAGE AS IT HAS NOT BEEN RETURNED TO CO. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN UNSUCCESSFUL. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE.
MFR RECEIVED A REPORT OF A PT FALLING THROUGH A TEAR IN A PT SLING. THIS ALLEGEDLY RESULTED IN THE PT SUSTAINING BROKEN BONES IN BOTH LEGS. THE TEAR APPEARS TO HAVE BEEN CAUSED BY THE SLING REPEATEDLY COMING INTO CONTACT WITH AN ABRASIVE SURFACE AND IS NOT CONSIDERED TO BE THE RESULT OF NORMAL WEAR.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS-CYLINDERS.
POSSIBLE PERFORATION DURING ESOPHAGEALGASTRODUODENOSCOPY WITH DILATATION. PT TRANSFERRED TO TERTIARY HOSP FOR FOLLOW-UP CARE. SUB-MUCOSA PENETRATION ONLY IDENTIFIED DURING FOLLOW-UP CARE.
CO RECEIVED INFO ON A DEATH CERTIFICATE THAT THE PT HAD EXPIRED DUE TO CARDIAC ARREST AS A CONSEQUENCE OF INCESSANT VENTRICULAR TACHYCARDIA.
THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY CO. D8. EXPLANTED TO DATE CO HAS NEITHER RECEIVED THE ICD NOR BEEN INFORMED THAT THE DEVICE HAS BEEN EXPLANTED. DISCLAIMER: THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OF CULPABILITY FOR ANY AND/OR ALL ASPECTS OF THIS EVENT, AND MAY BE BASED INCOMPLETE AND/OR UNSUBSTANTIATED INFO.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE--FLUID LOSS.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS -WOULD NOT INFLATE.
ON 4/22/96 AM AUS DEVICE WAS IMPLANTED. ON 9/5/96 THE BALLOON WAS REVISED. INFO ACQUIRED ON 9/17/96 INDICATES A REVISION SURGERY IS SCHEDULED FOR 10/3/96, DUE TO SCROTUM HEMATOMA.
PT EXPERIENCED PAIN AND INFECTION IN KNEE. REVISION SURGERY ON 9/27/96 FOUND DELAMINATION OF TIBIAL INSERT.
H3, H6 - NON-DESTRUCTIVE VISUAL EVALUATION WAS PERFORMED ON THE 86-4619 PFC PLI TIBIAL INSERT. WEAR WAS OBSERVED ON THE ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE INSERT DURING SURGERY TO INVESTIGATE SOURCE OF KNEE PAIN AND POSSIBLE INFECTION. THE ARTICULATING SURFACES OF BOTH CONDYLES OF THE TIBIAL INSERT SHOWED AREAS OF BURNISHING, DELAMINATION, PITTING, AND AMBER DISCOLORATION. THE INFERIOR SIDE OF THE INSERT HAD LIGHT BURNISHING OVER MOST OF THE SURFACE. IN SUMMARY, DURING SURGERY TO INVESTIGATE THE SOURCE OF ANINFECTION AND COMPLAINTS OF KNEE PAIN, A WORN PFC TIBIAL INSERT WAS OBSERVED AND REPLACED. THERE WERE NO APPARENT MATERIAL OR MFG DEFECTS NOTED ON THIS COMPONENT.
54 YR OLD PT PRESENTED TO DEVICE CLINIC WITH INCREASED SHOCKS. PT HAS ICD WITH EPICARDIAL PATCHES AND SENSING LEADS. UPON EVALUATION OF ICD, OVERSENSING NOTED PER BEEP-O-GRAM. DEVICE DISABLED, PT ADMITTED AND PLAN REVISION OF LEAD SYSTEM. NOT DETERMINED AT THIS TIME IF LEADS FRACTURED VERSUS INSULATION BREAK.
THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OF CULPABILITY FOR ANY AND/ORALL ASPECTS OF THIS EVENT, AND MAY BE BASED UPON INCOMPLETE AND/OR UNSUBSTANTIATED INFO. OTHER EXPIRATION DATE: 12/93. OTHER DEVICE MANUFACTURE DATE: 12/90.
A DL 9.5 FR. 40 CC IAB WAS INSERTED INTO THE PT (WITHOUT A SHEATH) FOR SUPPORT FOR SURGERY. AFTER INSERTION THE DOCTOR FELT THE BALLOON WAS TOO SHORT AS SEEN UNDER FLUOROSCOPY. IMMEDIATELY AFTER INSERTION, LOW AUGMENTATION WAS NOTED BUT THE DOCTOR DECIDED TO CONTINUE WITH IABP AND THE BALLOON PUMPED FOR THREE HOURS. THE PT WENT ON TO EXPIRE WITH THE IAB IN PLACE. THE CONTACT AT THE FACILITY STATED THAT THE DOCTOR FELT THAT THE IAB WAS "TOO SHORT" AND FELT THAT THE EVENT CONTRIBUTED TO THE PT'S DEATH. (THE PT WAS EXTREMELY ILL (LOW EJECTION FRACTION/LOW BLOOD PRESSURE) PRIOR TO THERAPY AND WAS PLACED ON IABP FOR SUPPORT). EVENT COMPLICATIONS: PT WENT ONTO EXPIRE - REPORTED 9/20/96. PT'S CURRENT STATUS: EXPIRED - RPT'D 9/20/96.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO COFOR EVAL. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. ANY ADD'L INFO RECEIVED BY.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO CUFF EROSION AT THE URETHRA. ADD'L LOT AND SERIAL NUMBER: BQ912 006.
PUMP PERFORMED WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS.
IT WAS REPORTED TO CO THAT THE X-RAY GENERATOR FAILED AND EMITTED SMOKE INTO THE ROOM. APPARENTLY THERE WAS ALSO A SMELL OF CHLORINE FROM THIS INCIDENT. THIS WAS DURING A DIGITAL FLUOROSCOPY PROCEDURE AND CAUSED A LOSS OF IMAGE.
THE INFO CONTAINED IN THE MDR IS OF A TYPE CUSTOMARILY HELD IN STRICT CONFIDENCE AND REGARDED AS PRIVILEGED BY CO UNDER 21 CFR20.61. THEREFORE, GE REQUESTS THAT THE FOOD AND DRUG ADMIN TREAT THAT PORTION OF THE MDR RELATING SPECIFICALLY TO THE PRODUCT AS CONFIDENTIAL COMMERCIAL INFO UNDER 21 CFR803.9(B). THE INFO CONTAINED IN THE SUBJECT REPORT(S) HAS NOT BEEN SUBSTANTIATED BY THE CO. THE CONTENT OF THE REPORT(S) HAS NOT BEEN SUBSTANTIATED BY THE CO. THE CONTENT OF THE REPORT(S) DOES NOT CONSTITUE AN ADMISSION BY THE GENERAL ELECTRIC CO THAT A DEVICE HAS MALFUNCTIONED NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A DEVICE AND A DEATH OR INJURY.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO MALFUNCTION. ADD'L SERIAL NUMBER: 1052L 023. ADD'L LOT NUMBER: 1052L 023.
THE PUMP AND BALLOON WERE REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO PAIN AND PT DISSATISFACTION -CYLINDER CAUSING PAIN TO SEX PARTNER.
POSSIBLE PERFORATION DURING ESOPHAGEALGASTRO-DUODENOSCOPY WITH DILATATION. PT TRANSFERRED TO TERTIARY HOSP FOR FOLLOW UP CARE. SUB-MUCOSA PENETRATION ONLY INDENTIFIED DURING FOLLOW UP CARE.
#10 COULD NOT EVALUATE PRODUCT AS PRODUCT NOT RETURNED. CONTRARY TO D9, CONFIRMED NO RETURNED VIA PHONE. B1 IS CONSIDERED A MALFUNCTION BY CFR DEFINITION AND SHOULD BE CONSIDERED A PRODUT PROBLEM. SEE USER FACILITY MEDWATCH. 611996090058.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -BETWEEN THE INFLATE/DEFLATE DEVICE AND TUBING OF RIGHT CYLINDER.
VASCULAR GRAFT TORE DURING IMPLANT, WAS REPAIRED BY SUTURE, THEN OCCLUDED AND WAS FINALLY REPLACED TOTALLY.
METHOD: CO DID NOT OBTAIN THE EXPLANTED VASCULAR GRAFT, HOWEVER CO EXAMINED THE LABELING (CODE 36) OF INVENTORIED GRAFTS (CODE 13) AND CO EXAMINED PRODUCTION RECORDS FOR THE GRAFT IN QUESTION (CODE 80 - "OTHER". THEREFORE, CO BELIEVES THIS INCIDENT IS AN "ANTICIPATED ADVERSE REACTION -SHORT TERM", IN THAT OCCLUSIONS ARE KNOWN TO OCCUR IN THE SHORT TERM WITH OR WITHOUT THE GRAFT BEING DAMAGED DURING IMPLANTATION. CONCLUSIONS: CO CONCLUDES THIS IS A DEVICE FAILURE RELATED TO USER HANDLING (CODE 61), AS THE GRAFT PASSED THE ROUTINE QUALITY CONTROL TESTS USING PRESSURED SALINE TO TEST THE INTEGRITY OF THE GRAFT AND THE GRAFT PASSED. CO SEES NO INDICATION OF AN INCREASING TREND IN INCIDENTS OF THIS SORT. IT IS NOT NECESSARY TO PURSUE PT INFO, SINCE THIS KIND OF EVENT IS INDEPENDENT OF THE PT TYPE OR CONDITION.
THE DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPY PROCEDURE FOR LEFT OOPHORECTOMY, FULGERATION OF ENDOMETRIOSIS AND LYSIS OF ADHESIONS OF THE ABDOMINAL WALL. THE PT EXPERIENCED POST-OPERATIVE SYMPTOMS AND WAS RE-ADMITTED FOR OBSERVATION. A EXPLORATORY LAPAROSCOPY WSA PERFORMED AND A HEMATOMA WAS OBSERVED ON THE ABDOMINAL WALL WITH BLEEDING FROM THE RIGHT EPIGASTIC ARTERY. THE PT WAS TRANSFUSED AND THE VESSEL WAS REPAIRED. THE SOURCE OF THE VESSEL DAMAGE HAS NOT BEEN IDENTIFIED.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO MALFUNCTION. ADD'L SERIAL NUMBER: 9801J 006. ADD'L LOT NUMBER: 9952H 014.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS-RIGHT SIDE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE RIGHT COMMON ILIAC ARTERY AND DISTAL VENA CAVA WERE PERFORATED. A FEMORAL LAPAROTOMY WAS PERFORMED TO REPAIR THE DAMAGE. THE HOSP HAS REPORTED THE PT HAS RECOVERED.
10/18/96 - SUBMISSION OF INITIAL REPORT TO FDA BY MFG. UF REPORTED THE FOLLOWING PT CODE WHICH WAS NOT INCLUDED IN BOX F-10 OF THIS SUBMISSION: 1987 - PERFORATION OF ORGAN. THE INFO RECEIVED FROM THE UF DOES NOT INDICATE AN ORGAN WAS PERFORATED. THE HOSP WILL NOT RELEASE THE DEVICE FOR EVAL AT THIS TIME.
ON SUNDAY, 9/15/96 PT WAS SENT TO THE HOSP WITH A ASTHMATIC PANIC ATTACK. THE PT WAS DISCHARGED ON TUESDAY, 9/17/96. PT STATED THE UNIT WAS LOCKING UP ON HIM. HE WAS TAPPING ON THE UNIT. THE UNIT HAS GONE INTO CONTINUOUS FLOW.
CO IS THE MFR OF THE OXYGEN CONSERVING DEVICE. ALSO, CO IS THE DISTRIBUTOR OF THE REGULATOR MODEL FR-870. DEVICE QUIT WORKING. PT WAS SENT TO THE HOSP. THE UNIT UNDER INVESTIGATION WAS SOLD TO CUSTOMER NO. 1224-2 ON 6/19/95. IT WAS FINAL TESTED AND RELEASED TO PRODUCTION ON 6/12/95. THE CONSERVER WAS REC'D WITH THE REGULATOR COVERED UNDER A SEPARATE RMA NO. 4789. AS REPORTED IN RMA 4789 THE REGULATOR COULD NOT POSSIBLY CONTRIBUTE TO THE FAILURE OF PRODUCT AS THE REGULATOR WAS WITHIN SPECS. THE CAUSE OF FAILURE WAS THE VALVE LOT NO. L 94 MADE BY KIP. THE VALVE SPRING WAS STUCK IN THE OPEN POSITION. WHEN THE VALVE IS OPEN, THE UNIT WILL NOT PULSE. UNIT AND REGULATOR WERE REPLACED. ALL KIP VALVES HAVE TO BE REPLACED WITH VALVE WHEN A UNIT IS RETURNED FOR REPAIRS. THE UNIT UNDER INVESTIGATION IS KEPT IN THE RETURNED FOR CREDIT STORAGE. PT WAS SENT TO THE HOSP. A FIXED REGULATOR WAS REC'D WITH THE CONSERVER, COVERED UNDER A SEPARATE RMA NO. 4686. THE REGULATOR WAS THEN HOOKED UP TO A FULL OL 150 OXYGEN CYLINDER WITH 1200 PSI PRESSURE, PRESSURE GAUGE AND FLOW METER SET UP. THERE WAS NO LEAK OBSERVED. PRESSURE AND FLOW RATE WAS 20.5 PSI AND 3.75 LPM RESPECTIVELY. ALL PARAMETERS WERE WITHIN SPECS. THE REGULATOR WAS WORKING PERFECTLY AND IT COULD NOT CONTRIBUTE TO THE REPORTED FAILURE OF THE PRODUCT THAT WAS USED WITH IT. THE REGULATOR WAS REPLACED WITH A BRAND NEW UNIT AND KEPT IN THE RETURNED FOR CREDIT STORAGE.
THE ACETABULAR COMPONENT WAS REVISED FOR UNKNOWN REASONS. THE FEMORAL STEM AND FEMORAL HEAD COMPONENTS WERE ALSO REMOVED AT THIS TIME.
SUMMARY OF EVAL: REQUESTS WERE MADE TO OBTAIN THE DEVICE FROM THE USER FACILITY. THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, EVAL OF THIS EVENT CANNOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR THE ACETABULAR AND FEMORAL HEAD COMPONENTS WERE REVIEWED AND NO DISCREPANCIES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE FEMORAL STEM COULD NOT BE PERFORMED, AS THE CATALOG NUMBER AND LOT CODE ARE UNKNOWN. THE INFO PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THIS EVENT IS ASSOCIATED WITH THE DEVICE.
REPORT ALLEGES PT RECEIVED BREAST IMPLANTS ON 11/21/78. REPORT ALSO ALLEGES THE PT'S IMPLANTS WERE RUPTURED; THEREFORE, SHE HAD REMOVAL ON 9/9/96.
METHOD: 86B WEIGHT MEASUREMENT. RESULTS: 100C SLIGHT AMBER COLOR; 100E FOREIGN MATERIAL; 100G CLOUDY; 100H LOSS OF SHELL INTEGRITY, ENVELOPE TEAR; 100I WEIGHT LESS THAN SPECIFIED. DEVICE 1 OF 2 CONCLUSION: 68 CAUSE OF TEAR(S) UNDETERMINED; FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED; CAUSE OF CLOUDINESS UNDETERMINED; GEL NOT ALL RETURNED. DEVICE 2 OF 2 CONCLUSION: 68 CAUSE OF TEAR(S) UNDETERMINED; FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED; CAUSE OF CLOUDINESS UNDETERMINED; WEIGHT WITHIN SPECIFICATION LIMITS.
METHOD: 86B WEIGHT MEASUREMENT. RESULTS: 100C SLIGHT AMBER COLOR; 100E FOREIGN MATERIAL; 100G CLOUDY; 100H LOSS OF SHELL INTEGRITY, ENVELOPE TEAR; 100I WEIGHT LOSS THAN SPECIFIED. DEVICE 1 OF 2 CONCLUSION: 68 CAUSE OF TEAR(S) UNDETERMINED; FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED; CAUSE OF CLOUDINESS UNDETERMINED; GEL NOT ALL RETURNED. DEVICE 2 OF 2 CONCLUSION: 68 CAUSE OF TEAR(S) UNDETERMINED; FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED; CAUSE OF CLOUDINESS UNDETERMINED; WEIGHT WITHIN SPECIFICATION LIMITS.
THE LEAD WAS EXPLANTED ELECTIVELY. FAILURE ANALYSIS INDICATES THE LEAD IS FRACTURED WITHOUT PROTRUSION.
THIS ENTIRE FORM COMPLETED BY MFR. LEAD WAS REC'D WITH THE J STIFFENER WIRE FRACTURED. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED AT WELD SITE. THE PROXIMAL SECTION OF STIFFENER WIRE MEASURES 87MM AND HAS MIGRATED DOWN LEAD BODY 2MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE LENGTH OF THE J STIFFENER WIRE WAS REC'D WITH RECORDED MEASUREMENTS ADDING UP TO 87MM. X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURE.
PLAINTIFF ALLEGES THAT, "AS A DIRECT AND PROXIMATE RESULT OF BEING CONTINUOUSLY EXPOSED TO THE LATEX AND SUBSTANCE COMBINATION PLAINTIFF DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS, AND LIVER PROBLEMS CAUSED BY EXTENDED EXPOSURE TO THE GLOVES.
DATE SENT TO FDA: 10/28/96. H6 NA WAS USED DUE TO NO SAMPLE, NOT LOT NUMBER AVAILABLE FOR INVESTIGATION.
THE CUFF WAS REMOVED FROM THE PT, REASON NOT INDICATED, AND REPLACED. UNABLE TO OBTAIN ADD'L INFO.
DEVICE IN USE ON ULNAR NERVE SET AT 80MA ALL THE TIME DURING PROCEDURES. OBSERVED THAT PT WAS BURNED AT THE SITE OF THE ELECTRODES, ONE SITE LEAVING TWO BLACK DOTS, THE OTHER SITE A SMALL BLISTER. UNIT TAKEN OUT OF SERVICE AND FOUND TO BE OPERATING CORRECTLY BY BIOMEDICAL ENGINEERING.
HOSPITAL CONTACTED ON SEVERAL OCCASIONS IN FOLLOW-UP TO THIS REPORT BUT DECLINED TO MAKE UNIT AVAILABLE FOR EVAL. OR PROVIDE SIGNIFICANT FURTHER INFO. THEY INTEND TO FILE USER REPORT WITH FDA. CO BELIEVES THAT USE OF THE DEVICE AT MAXIMUM CURRENT SETTING AND NOT CORRECTLY ESTABLISHING SUPRAMAXIMAL STIMULATION LEVEL MAY BE A CONTRIBUTING FACTOR TO THIS INCIDENT. CO IS NOT AWARE OF ANY OTHER REPORTS OF THIS NATURE CONCERNING THIS DEVICE.
OPERATIVE REPORTS ARE WRITTEN IN GERMAN. CO IS IN THE PROCESS OF HAVING THE DOCUMENTS TRANSLATED TO ENGLISH; THEREFORE, CO MAY HAVE MORE DETAILED INFO AT A LATER DATE. CONCLUSION: 68A OTHER (NO DEVICE RETURNED).
PATIENT ALLEGES HAVING ENCAPSULATION OF THE RIGHT BREAST; THEREFORE, ON OCTOBER 17, 1978 SHE HAD AN OPEN CAPSULOTOMY WITH REMOVAL AND REINSERTION AND ON NOVEMBER 29, 1978 SHE HAD A CLOSED CAPSULOTOMY.
ON 5/25/95 AN AUS DEVICE WAS IMPLANTED. ON 12/7/95 THE BALLOON WAS REVISED. ON 9/10/96 A TANDEM CUFF WAS IMPLANTED DUE TO RECURRING INCONTINENCE. NO COMPONENTS WERE REMOVED OR REPLACED.
SURGERY (TOTAL KNEE REVISION) WAS REQUIRED TO REPLACE A BROKEN KNEE FEMORAL COMPONENT (TOTAL KNEE).
A REPORT WAS RECEIVED OF AN ENDOSSEOUS DENTAL IMPLANT WAS EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. BONE LOSS WAS NOTED.
86 = DIMENSIONAL ANALYSIS. 100 = VISUAL EXAM SHOWED SEVERE TOOL DAMAGE AROUND THE COLLAR OF THE IMPLANT WHICH MAY BE ATTRIBUTED TO THE REMOVAL PROCEDURE. BONE TISSUE WAS ALSO NOTED IN THE BASKET OF THE IMPLANT. THE RETURNED COMPONENT MET THE REMAINING CO VISUAL AND DIMENSIONAL SPECS.
DISTRIBUTOR WAS INFORMED THAT THERE WAS NOISE ON THE SENSE PACE LEAD AND ON 8/28/96 BOTH ML-150 LEADS S/N 85051B, AND S/N 81641B WERE REPLACED. THERE WAS NO INDICATION THAT THE ICD DID NOT PERFORM TO SPEC.
AN ABUTMENT SCREW FRACTURED INSIDE AN IMPLANT.  THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
OPERATIVE REPORTS ARE WRITTEN IN GERMAN. CO IS IN PROCESS OF HAVING THE DOCUMENTS TRANSLATED TO ENGLISH; THEREFORE, CO MAY HAVE MORE DETAILED INFO AT A LATER DATE. CONCLUSION: 68A-OTHER (NO DEVICE RETURNED).
PT ALLEGES A MAMMOGRAM MARCH 30, 1990 SHOWED RUPTURE OF HER LEFT IMPLANT. PHYSICIANS LETTER STATED UPON REMOVAL BOTH IMPLANTS WERE FOUND TO BE RUPTURED.
DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION-INADEQUATE RIGIDITY AND LENGTH. ANOTHER DEVICE WAS IMPANTED.
REVISION SURGERY PERFORMED FOLLOWING APPARENT FRACTURE OF A POSTERIOR CONDYLE.
H3, H6 - A NON-DESTRUCTIVE EVAL WAS PERFORMED ON THE 86-4108 POROUS COATED FEMORAL KNEE COMPONENT. THE FEMORAL COMPONENT WAS RECEIVED AS TWO SEPARATE PIECES DUE TO FATIGUE FRACTURE OF THE MEDIAL CONDYLE AT THE POSTERIOR, DISTAL CHAMFER. THE FATIGUE STRIATIONS ON THE LATERAL SIDE APPEARED TO PROGRESS ACROSS THE FRACTURE SURFACE WHICH SUGGESTS THAT THE FRACTURE ORIGIN IS MOST LIKELY ON THE LATERAL SIDE. METALLOGRAPHIC EXAMINATION SHOWED EVIDENCE OF FATIGUE CRACK PROPOGATION BUT DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS. THE 2MM TO 3MM CEMENT MANTLE USED TO FIX THE FEMORAL COMPONENT SHOWED GOOD CEMENT PENETRATION INTO THE POROUS BEADED SURFACE EXCEPT ON THE MOST DISTAL FLAT BEADED SURFACE ON THE MEDIAL SIDE OF THE COMPONENT. IN SUMMARY, WHILE THE FAILURE MODE WAS ONE OF FATIGUE, INSUFFICIENT EVIDENCE WAS PRESENT TO DETERMINE THE EXACT CAUSE OF THE FAILURE. NO MATERIAL OR MANUFACTURING DEFECTS WERE SEEN ON THE COMPONENT.
ON 10/10/96, CO RECEIVED AN ACETABULAR REAMER SHELL, 54 MM, FROM HOSP WITH A COMPLAINT THAT THE PRODUCT WAS ETCHED INCORRECTLY. ON 10/16/96, CO CONFIRMED THAT THE DEVICES ARE ETCHED AS A 54 MM SHELL MAY BE A 55 MM ACETABULAR REAMER SHELL.
DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT NUMBER: BY711 002. ADD'L SERIAL NUMBER: BY711 002.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE.
RPTR HAD 2 EMPLOYEES WITH EXPOSURE TO VAPORS AND HAD ACUTE RESPIRATORY DISTRESS. PERSON RECEIVED MEDICAL ATTENTION, DEGREE OF INTERVENTION NOT KNOWN, DID NOT REQUIRE HOSPITALIZATION. DATE OF THIS EVENT IS APPROX. THIS EVENT WAS DISCOVERED IN CONVERSATION WITH PERSON AT USER FACILITY.
DATE SENT TO FDA: 10/18/96. HAD 2 EMPLOYEES THAT HAD EXPOSURE TO VAPORS AND HAD ACUTE RESPIRATORY DISTRESS. ONE EMPLOYEE HAD FIRST SYMPTOMS ABOUT 6 MONTHS AGO, AND SECOND EMPLOYEE HAD SYMPTOMS ABOUT JULY OF THIS YEAR. THIS IS THE FIRST TIME THAT CO HAS LEARNED OF THIS OCCURRENCE. BOTH EMPLOYEES HAVE NEEDED TO SEEK MEDICAL ATTENTION. THE ACCOUNT HAS SUBSEQUENTLY REMOVED QUESTIONABLE PRODUCTS. NO FURTHER EMPLOYEE EVENTS HAVE OCCURRED SINCE DISCONTINUATION OF THESE PRODUCTS. IT WAS REPORTED THAT THE FIRST EMPLOYEE DEVELOPED MILD RESPIRATORY SYMPTOMS SUCH AS COUGHING, HEADACHE, DYSPNEA, AND SINUS INFECTIONS AFTER EXPOSURE TO PRODUCTS OF THIS TYPE NOT MFG OR DISTRIBUTED BY CO. THESE CHEMICALS WERE DISCONTINUED AND CO PRODUCT USE WAS INITIATED. THE SAME EMPLOYEE DEVELOPED SIMILAR SYMPTOMS AFTER CO PRODUCT WAS INTRODUCED. AND A SECOND EMPLOYEE NOT AFFECTED BY THE NON CO PRODUCT HAD SEVERE RESPIRATORY SYMPTOMS AFTER EXPOSURE TO CO PRODUCT REQUIRING AN ER VISIT, GIVEN MEDICATIONS FOR REVERSAL OF SYMPTOMS, AND MISSED SEVERAL DAYS WORK. SYMPTOMS OF THIS EPISODE INCLUDED DYSPNEA, THROAT SWELLING, AND GAGGING. THIS EVENT WAS CONSIDERED AN ASTHMATIC EPISODE AS REPORTED BY CALLER. THIS COMPLAINT OPENED FOR MDR DETERMINATION AND REPORTING. NO SAMPLE IS AVAILABLE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE-MALFUNCTIONING.
PT STATES "HE IS NOT GETTING ENOUGH OXYGEN," PT DESATURATED ON THE CONSERVER AND REGULATOR. PT ALSO STATES THAT THE YELLOW LIGHT WAS ON, AND THAT HIS NEW DR DIDN'T WANT HIM TO HAVE IT. WITH NEW UNIT, PT STATES HE IS GETTING A BIGGER PUFF.
UNIT UNDER INVESTIGATION. WAS SOLD TO CUSTOMER ON 11/2/95. IT WAS FINAL TESTED & RELEASED TO PRODUCTION ON 10/12/95. CONSERVER WAS RECEIVED WITH REGULATOR COVERED UNDER A SEPARATE RMA # 4267. AS STATED IN RETURNED PRODUCT INVESTIGATION REPORT FOR RMA 4267, REGULATOR COULD NOT POSSIBLY CAUSE FAILURE, IF REGULATOR WAS INSTALLED WITH GASKET. CO COULD NOT HOWEVER, ASCERTAIN IF GASKET WAS PRESENT OR MISSING, WHEN CONSERVER WAS IN USE WITH REGULATOR. SIMULATED USE TEST: UNOPENED CONSERVER WAS HOOKED UP TO AN OXYGEN OL CYLINDER FITTED WITH RETURNED REGULATOR & A TUBING WITH CANNULA TO SIMULATE ACTUAL USE OF CONSERVER & REGULATOR. TEST TECH INHALED THROUGH CANNULA. SHOTS OF OXYGEN WERE CONFIRMED, SHOWING THAT CONSERVER WAS PULSING & OPERATING NORMALLY. BATTERY VOLTAGE & SHOT SIZE: VOLTAGE OF BATTERY THAT CAME IN WITH CONSERVER WAS MEASURED AT 1.28 VOLTS. SHOT SIZE MEASURED AT AN AVERAGE OF 32 ML, WHICH WAS WITHIN ACCEPTABLE RANGE OF 30 TO 40 ML. BATTERY WAS THEN REPLACED WITH A NEW 1 THAT MEASURED AT 1.47 VOLTS. SHOT SIZE WAS MEASURED & REMAINED AT 32 ML. BATTERY COULD NOT AFFECT SHOT SIZE. SENSITIVITY & TRIGGERING: SENSITIVITY OF UNOPENED CONSERVER, WAS CHECKED USING THE TESTER, WITH TEST GAS SUPPLIED BY OL 150 CYLINDER & RETURNED REGULATOR. SENSITIVITY WAS OUT OF ACCEPTABLE RANGE & NO PULSE WAS DETECTED. CONSERVER WAS OPENED & SENSOR WAS REPLACED.  ALTHOUGH A SENSITIVITY OF 330 MSEC SHOWED ON OSCILLOSCOPE, THIS WAS MORE MAXIMUM ACCEPTABLE VALVE OF 300 MSEC. OLDER SENSOR WAS PUT BACK & SENSITIVITY POTENTIOMETER WAS ADJUSTED UNTIL SENSITIVITY WAS AT 160 MSEC. CONSERVER PULSED & PERFORMED SATISFACTORILY. LEAK TEST: CONSERVER WAS TESTED FOR INPUT LEAKS, LEAK THROUGH & CONTINUOUS FLOW. NO LEAKS OF ANY KIND WERE OBSERVED. GENERAL OBSERVATIONS: FAILURE COULD BE ATTRIBUTED TO SENSOR. SENSOR WAS NOT SENSITIVE ENOUGH TO TRIGGER A PULSE WHEN USER INHALED. SENSOR'S SENSITIVITY WAS OUT OF ADJUSTMENT. IT IS POSSIBLE THAT SENSOR'S SENSITIVITY CHANGED AFTER SOMETIME, THAT IT REQURIED ADJUSTMENT. IT IS ALSO POSSIBLE THAT POTENTIOMETER WAS TAMPERED WITH. ADJUSTMENT SENSITIVITY & CALIBRATE UNIT. PREVENTIVE MEASURES: CLEAN PCB THOROUGHLY. PRODUCT DISPOSITION: RETURN UNIT TO CUSTOMER AFTER ADJUSTING, CALIBRATING & CLEANING.
WHILE TRANSPORTING COT AND PT IN INCLINED POSITION, COT FOLDED. ONE EMT SUSTAINED A BROKEN FINGER IN AN ATTEMPT TO STABILIZE UNIT.
H-3 (81, OTHER). UNIT WILL BE EVALUATED BY AN INDEPENDENT SVC AGENT.
DEVICE WAS REMOVED FROM THE TP DUE TO INFECTION.
REPORTER ALLEGES PT RECEIVED BREAST IMPLANTS IN 10/82. REPORTER ALSO ALLEGES TWO IMPLANTS WERE REMOVED ON 9/17/96 BECAUSE OF CAPSULAR CONTRACTURE.
CONCLUSION: 68A-OTHER (NO DEVICE RETURNED).
INFORMATION RECEIVED ON 12/2/96 INDICATES ONLY CYLINDERS WERE REMOVED.
IT IS REPORTED TO CO THAT WHILE BEING SUPPORTED BY A LVAD, THE PT EXPERIENCED SYMPTOMS OF A BLOOD LEAK IN THE SYSTEM. THE PT WAS TAKEN TO THE OR WHERE THE OUTFLOW GRAFT OF THE DEVICE WAS REPLACED.
WHEN PHYSICIAN WAS WITHDRAWING THE SHEATH FFROM THE RIGHT FEMORAL ARTERY AFTER A CARDIAC CATHETERIZATION, THE HUB SEPARATED FROM THE BODY OF THE SHEATH. THE BODY OF THE SHEATH REMAINED ON THE PT. THE SEPARATED PORTION WAS REMOVED AND THERE WERE NO PT COMPLICATIONS.
THE SAMPLE WAS RETURNED FOR EVALUATION. CO'S EXAMINATION FOUND THAT THE SHEATH HAD SEPARATED INSIDE THE HUB. IT APPEARS THAT THE SHEATH BODY WAS PULLED BY THE USER WITH A SIGNIFICANT FORCE CAUSING THE SEPARATION. THERE IS NO INDICATION OF ANY MFR OR MATERIAL DEFECT.
THE DEVICE HAS NOT BEEN RETURNED TO MFR; THEREFORE, EVAL OF THE EVENT CANNOT BE PERFORMED. DEVICE HISTORY RECORD FOR THE LOT CODE OF THE ROD WAS REVIEWED AND NO DISCREPANCIES WERE OBSERVED. THE INFO PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THIS EVENT WOULD BE ASSOCIATED WITH THE DEVICE. SECTION F INFO WAS REQUESTED FROM THE USER FACILITY. THE INFO IS UNOBTAINABLE. THIS SECTION WAS COMPUTED BY THE MFR.
A REPORT WAS RECEIVED OF AN ENDOSSEOUS DENTAL IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE PT HAD AN ORAL CANCER RESECTION AND UNDERWENT POST-OPERATIVE RADIATION THERAPY AND HYPERBARIC OXYGEN TREATMENT BEFORE THE IMPLANT WAS PLACED.
86 = DEVICE NOT RETURNED FOR EVALUATION.
AN ABUTMENT SCREW FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS -RIGHT CYLINDER. ANOTHER DEVICE WAS IMPLANTED.
PT ALLEGES RECEIVING A TESTICULAR IMPLANT ON AN UNKNOWN DATE. PT ALSO ALLEGES HE HAS EXPERIENCED GREAT PAIN AND SUFFERING AS A RESULT OF THIS IMPLANT. THE IMPLANT IRRITATED, BECAME PAINFUL AND GAVE HIM GREAT DISCOMFORT. PT SCRATCHED GROIN AREA AS A RESULT OF THE IRRITATION. IMPLANT FELL OUT AS A RESULT OF HIS INCESSANT SCRATCHING AND THE SKIN ON HIS SCROTUM WAS SPLIT.
PT ALLEGES RECEIVING TWO TOE IMPLANTS ON AN UNK DATE AND OF AN UNK MFR. PT ALSO ALLEGES BOTH IMPLANTS HAVE FRACTURED AND ONE HAS ALREADY BEEN REMOVED AND REPLACED WITH A STEEL PIN AND BONE FROM HER HIP.
ADDITIONAL INFORMATION RECEIVED ON 12/16/96 INDICATES ADDITIONAL REASON DUE TO INFECTION.
THE CLEAR HEMOSTASIS VALVE WAS UNSCREWED FROM THE SHEATH AND BLEEDING WAS NOTED AROUND THE VALVE. IABP CONTINUED WITHOUT ANY FURTHER PROBLEMS. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVALUATION. THE VALVE WAS DISCARDED BY THE FACILITY.
THE PRODUCT HAS NOT BEEN RETURNED TO CO FOR EVALUATION. THE PRODUCT WAS DISCARDED BY THE FACILITY. A SAFETY ALERT WAS ISSUED ON 10/1/96.  COPY OF THIS ALERT WAS SENT TO THE DISTRICT OFFICE.
DURING A PTCA, PROCEDURE, DIFFICULTY WAS ENCOUNTERED ADVANCING THE GUIDE WIRE. THE TIP OF THE GUIDE WIRE FRACTURED AS THE WIRE WAS REMOVED. THE TIP WAS RETRIEVED WITH A SNARE. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED KINKS THROUGHOUT THE SHAFT OF THE RETURNED BALLOON CATHETER. THE KINKS MAY HAVE CONTRIBUTED TO THE REPORTED WIRE MOVEMENT DIFFICULTIES. THE GUIDE WIRE USED DURING THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS.
ON 8/2/96 A THORACIC EPIDURAL CATHETER WAS PLACED INTO THE T7-T8 SPACE UNDER DIRECT VISION AND ADVANCED TO 8 CM INTO THE EPIDURAL SPACE INTRAOPERATIVELY DURING A POSTERIOR SPINAL FUSION WITH INSTRUMENTATION AND ILIAC CREST BONE GRAFT PROCEDURE. INTRAOPERATIVELY, THE EPIDURAL CATHETER WAS SUTURED INTO PLACE INTO THE SKIN. ON 8/5/96, WHEN A PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER AFTER CUTTING THE SUTURE, THE CATHETER FRACTURED AND ONLY A SMALL PORTION PRESENTED, LEAVING APPROX 10 CM OF RETAINED CATHETER. AN ATTEMPT WAS MADE TO REMOVE THE RETAINED CATHETER UNDER FLUOROSCOPY GUIDANCE BUT THIS WAS UNSUCCESSFUL DUE TO THE CATHETER NOT BEING RADIOPAQUE. THEREFORE, THE PT WAS TAKEN TO OR WHEN THE CATHETER WAS REMOVED.
RPTR ALLEGED PT RECEIVED A RIGHT BREAST IMPLANT ON 4/7/89. RPTR ALSO ALLEGES AFTER SURGERY, "PT DEVELOPED A SERIES OF PHYSICIAL CONDITIONS AND SYMPTOMS, ARTHRITIS AND TENDONITIS TYPE BODY PAIN, STIFFNESS, SORENESS AND FATIGUE WHICH REQUIRED MEDICAL CARE." IT'S ALSO STATES PT SUFFERED SEVERE, PERMANENT INJURIES INCLUDING PHYSICAL DISFIGUREMENT, PERMANENT PAIN OR DISABILITY, PHYSICAL PAIN AND MENTAL AND EMOTIONAL ANGUISH.
CONCLUSION: 68A OTHER(NO DEVICE RETURNED).
86 = DIMENSIONAL ANALYSIS. 100 = VISUAL EXAM SHOWED BONE TISSUE MATTER IN THE BASKET AREA OF THE IMPLANT, THEREFORE, A COMPLETE DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. THE PLASMA COATED AROUND THE COLLAR OF THE IMPLANT WAS PARTIALLY REMOVED WHICH MAY BE ATTRIBUTED TO THE REMOVAL PROCEDURE. THE RETURNED COMPONENT MET THE REMAINING CO VISUAL AND DIMENSIONAL SPECS.
D6 ORDER#5270. F10 2365-NOT LABELED. 2357-NOT LABELED. 1260-NOT LABELED 1528-NOT LABELED. 1161-NOT LABELED. THE EVAL IS STILL IN PROGRESS. ADD'L INFO WILL BE FORWARDED AS SOON AS IT BECOMES AVAILABLE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO RADIATION THERAPY FOR PROSTATE CANCER, GROSS FECAL CONTAMINATION.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK. TUBING WAS FUNCTIONAL.
HEALING ABUTMENT BROKEN DURING AN ABUTMENT CHANGE. NO PT INJURY REPORTED.
PT ALLEGES RECEIVING A BREAST IMPLANT IN THE EARLY 1980'S OF AN UNKNOWN MFR. PT ALLEGES HER IMPLANT RUPTURED.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED 11MM AND 62MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 25MM AND HAS MIGRATED DOWN LEAD BODY 65MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO 87MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURES.
IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE BALLOON RUPTURED AT 10 ATM (RBP=9 ATM) AND A DISSECTION OCCURRED. THE DISSECTION WAS REPAIRED WITH ANOTHER BALLOON. PT STATUS IS LISTED AS "OK".
RETURNED PRODUCT ANALYSIS REVEALED A CIRCUMFERENTIAL TEAR OF THE BALLOON MATERIAL. ANALYSIS ALSO REVEALED THE DISTAL HALF OF THE BALLOON WAS PROLAPSED OVER THE DISTAL TIP. THE BALLOON BURST AT 10 ATM (RPB-9 ATM). THE EXACT CAUSE OF THE TEAR COULD NOT BE DETERMINED. NO MATERIAL OR MANUFACTURING DEFICIENCIES WERE NOTED.
PUMP PERFORMNED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICAITONS. CYLINDER WAS FUNCTIONAL.
NO DEVICE RETURNED. NO CONCLUSION CAN BE DRAWN.
PT ALLEGES RECEIVING A RT BREAST IMPLANT IN APRIL 1984 AND A LT BREAST IMPLANT IN 1984 OR 1985 AS A REPLACEMENT. PT ALSO ALLEGES IN MAY 1986 SHE HAD ENDOCARDITIS AND COULD NOT RISK INFECTION AND IN OCTOBER 1986 HER LT IMPLANT BECAME HARD AGAIN. A MAMMOGRAM ON APRIL 10, 1995 SHOWED SIGN OF HER LT IMPLANT LEAKING AND THEN A BIOPSY ON OCTOBER 17, 1995 CONFIRMED THE LEAK. PT ALSO ALLEGES SHE FELT A HARD MASS ABOVE HER LT BREAST. PT HAD HER IMPLANTS BILATERALLY REMOVED ON MAY 6, 1996.
PUMP STARTED INFUSING AT 22:10 100 MG AT 6ML PER HR. (SALINE & INSULIN) AT 22:45 BAG WAS EMPTY.
PT ALLEGES RECEIVING IMPLANTS OF AN UNKNOWN MFR AND ON AN UNKNWON DATE. SHE ALLEGES "THEY BOTHER ME, AND I'M GOING TO GET THEN REMOVED." SHE ALSO STATES, " I WANT THEM OUT."
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO A "MALFUNCTIONING PROSTHESIS."
THE PT IS SUSPECTED TO HAVE SUFFERED ANAPHYLACTIC SHOCK DURING USE OF THE PRODUCT. THE PT'S BLOOD PRESSURE DROPPED AND AFTER SEVERAL MINS, ITCHING BEGAN AND ERYTHEMA WAS SEEN ORIGINATING FROM THE BREAST AND EXTENDING OVER THE BODY. THE CATHETER WAS REMOVED AND THE PT WAS ADMINISTERED EPINEPHRINE. HE RECOVERED WITHOUT COMPLICATIONS.
CO'S INVESTIGATION OF THIS INCIDENT THROUGH A DETAILED SEARCH OF THE LITERATURE PERTAINING TO THE SUBJECT DISCLOSED THAT INDIVIDUALS OF JAPANESE EXTRACTION ARE KNOWN TO HAVE HAD IMMEDIATE HYPERSENSITIVE REACTIONS FOLLOWING TOPICAL CHLORHEXIDINE ADMINISTRATION. A COMPONENT OF THE ANTISEPTIC CATHETER SURFACE TREATMENT IS CHLORHEXIDINE. CO SUSPECTS THAT THIS JAPANESE PT MAY HAVE BEEN HYPERSENSITIVE TO THE ANTISEPTIC SURFACE TREATMENT. ALTHOUGH CO HAS ONLY RECENTLY BECOME AWARE OF THIS SITUATION THROUGH A FEW INCIDENT REPORTS, CO HAS DECIDED TO REVISE THE PRODUCT LABELING TO CONTRAINDICATE THE CATHETER FOR PTS WITH KNOWN SENSITIVITY TO CHLORHEXIDINE. AS AN IMMEDIATE ACTION, CO IS IMPLEMENTING THE FOLLOWING LABELING ADDITIONS, EFFECTIVE 11/1/96: 1. A CONTRAINDICATION STICKER WILL BE PLACED PROMINENTLY ON THE UNIT PACKAGE LIDSTOCK OF ALL CO PRODUCTS, WHICH READS AS FOLLOWS: THE ANTISEPTIC SURFACE CATHETER IS CONTRAINDICATED FOR PTS WITH KNOWN HYPERSENSITIVITY TO CHLORHEXIDINE (REF TO PRODUCT INSTRUCTIONS FOR REFERENCES)." 2. A SUPPLEMENT TO THE INSTRUCTION BOOKLET IN THE FORM OF A YELLOW CARD WITH RED PRINTING WILL BE INCLUDED INSIDE THE TOP OF EACH INDIVIDUAL PRODUCT PACKAGE, WHICH READS AS FOLLOWS: THE ANTISEPTIC SURFACE CATHETER IS CONTRAINDICATED FOR PTS WITH KNOWN HYPERSENSITIVITY TO CHLORHEXIDINE. RARE, ISOLATED CASES OF HYPERSENSITIVE REACTIONS TO ANTISEPTIC SURFACE HAVE BEEN REPORTED IN JAPANESE PTS IN JAPAN ONLY (FIRST CASE REPORTED 5/96). THE LITERATURE INDICATES THAT INDIVIDUALS OF JAPANESE EXTRACTION ARE KNOWN TO HAVE HAD IMMEDIATE HYPERSENSITIVE REACTIONS FOLLOWING TOPICAL CHLORHEXIDINE ADMINISTRATION. IF ADVERSE REACTIONS OCCUR AFTER CATHETER PLACEMENT, REMOVE CATHETER IMMEDIATELY.
RETURNED PRODUCT ANALYSIS REVEALED RESIDUAL DRIED CONTRAST MEDIA THROUGHOUT THE SHAFT. DUE TO THE SHAFT CONDITION, TESTING RELATIVE TO THE REPORTED DEFLATION DIFFICULTIES COULD NOT BE PERFORMED. ANALYSIS ALSO REVEALED A KINK AND LEAK IN THE INFLATION LUMEN. THE KINK MAY HAVE RESTRICTED FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE SHAFT DAMAGE COULD NOT BE DETERMINED.
DR. REPORTED THAT A HEALING ABUTMENT SCREW BROKE INSIDE OF AN IMPLANT. THE IMPLANT WAS REMOVED DUE TO THE BROKEN SCREW. PT INJURY WAS NOT REPORTED.
PT ALLEGES RECEIVING BREAST IMPLANTS ON AN UNKNOWN DATE. PT ALSO ALLEGES PAIN AND INJURY.
CYLINDER HAD A WEAR LEAK. CYLINDER PERFORMED WITHIN SPECS.
DURING POST DILATATION OF A STENT WITH A PERIPHERAL DILATATION BALLOON OVER THIS REPORTED DEVICE THE BALLOON RUPTURED. THIS RESULTED IN THE WIRE BECOMING TRAPPED IN THE STENT WHICH LEAD TO TIP SEPARATION. THE DECISION WAS MADE TO LEAVE THE TIP OF THE WIRE IN VIVO.
THE INFO IN SECTION F WAS COMPLTED BY THE MFR. 1701-NOT LABELED FOR BOTH EVENT CODES. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM A HOSP OR FIELD CONTACT.
PT ALLEGES RECEIVING IMPLANTS APPROX. 30 YRS AGO (I.E. 1966) OF AN UNKNOWN MFR. SHE ALLEGES THEY HAVE CAUSED HER A GREAT DEAL OF PAIN AND DISCOMFORT OVER THE YRS BUT ARE STILL IN PLACE.
PT ALLEGES RECEIVING A BREAST IMPLANT ON AN UNKNOWN DATE. PT ALSO ALLEGES SHE HAS SUFFERED AN INJURY; HOWEVER, NO SPECIFICS WERE GIVEN.
PT ALLEGES RECEIVING BREAST IMPLANTS 21 YRS AGO (I.E. 1975) OF AN UNKNOWN MFR. PT ALSO ALLEGES HAVING HER IMPLANTS REPLACED ONE TIME DUE TO A RUPTURE; HOWEVER, NO SURGERY DATE WAS PROVIDED. PT STATES, "I GO IN ONCE A YR TO MY DR FOR A PROCEDURE TO RELEASE THE SCAR TISSUE THAT BUILDS UP AROUND THE IMPLANTS." REFERENCE MW072401A.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -TUBING CYLINDER.
CYLINDER WAS FUNCITONAL. CYLINDER HAD A FATIGUE LEAK.
COMPLAINANT STATES THE POLYETHYLENE COMPONENT OF THE PATELLA PROSTHESIS WAS CRACKED NECESSITATING ITS REMOVAL. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AS ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. D.6. THE EXACT SIZE OF THE DEVICE IS NOT KNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED. H.4. THE DEVICE MANUFACTURE DATE IS NOT KNOWN BECAUSE THE MANUFACTURING LOT NUMBER WAS NOT PROVIDED.
DEVICE STARTED INFUSING AT 22:10 100 MG AT 6 ML PER HR. (SALINE & INSULIN) AT 22:45 BAG WAS EMPTY.
PUMP WAS RETURNED & VISUALLY AND FUNCTIONALLY TESTED. PUMP WAS FOUND TO HAVE AN INCONSISTANCY (UNDER INFUSION) IN RATE ACCURACY. MECHANISM AND PRESSURE PLATES WERE INSPECTED AND A STICKY SUBSTANCE WAS FOUND INSIDE THE PRESSURE PLATE. ALTHOUGH THE REPORTED OVERINFUSION WAS NOT DUPLICATED IT IS SUSPECTED THAT THE PRESSURE PLATE MAY HAVE STUCK OPEN DUE TO THE STICKY SOLUTION, PREVENTING THE CAMS FORM PINCHING OFF THE TUBING AND RESULTING IN EXCESSIVE FLOW. THE PUMP WILL BE CLEANED, REPAIRED AND RETURNED TO THE CUSTOMER. THE CUSTOMER WILL BE INFORMED OF CO'S FINDINGS AND INFORMED THAT THE PUMP SHOULD BE CLEANED  SHOULD SPILLAGE OCCUR, PER THE INSTRUMENTS' DIR FOR USE PAGE 26. SECTION A,B,D, AND F-1-12 WERE FILLED OUT BY THE USER FACILITY (SEE ATTACHED MEDWATCH REPORT). SECTION F-14, G AND H WERE FILLED OUT BY THE MFR. FILE #09-96-60. MFR'S REPORT DATE 10/11/96.
TWO ABUTMENT SCREWS HAVE FRACTURED INSIDE OF IMPLANTS STILL IN THE PT'S MOUTH. THE FRAGMENTS WERE RETRIEVED SUCCESSFULLY.  PT INJURY WAS NOT REPORTED.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO A "MALFUNCTIONING PENILE PROSTHESIS."
CYLINDER HAD OR DAMAGE. CYLINDER HAD A WEAR HOLE IN INNER TUBE
PT ALLEGES RECEIVING BREAST IMPLANTS ON 11/8/85. PT ALSO ALLEGES SINCE 1987 SHE DEVELOPED HARDENING, PAIN, BURNING AND A RIPPLING SENSATION. PHYSICIAN STATES PT HAS BAKER GRADE II CAPSULE CONTRACTURE WITH PROSTHESTIC DISPLACEMENT AND DEFORMITY, RECURRENT PAIN, RESEMBLE SILICONE GEL AND FEAR DESPITE MEDICAL RESEARCH.
SURGEON ATTEMPTED REMOVAL OF 2X4 RT KIDNEY STONE WITH PRODUCT. THERE WAS NO PROBLEM INSERTING THE PRODUCT. WIRE BASKET WITH CAPTURED STONE BECAME LODGED IN THE URETERAL MUCOSA, DEVICE UNABLE TO BE REMOVED. PT WAS "RETURNED" TO SURGERY ON 8/22 FOR CYSTOTOMY, URETEROTOMY. SURGEON'S NOTES INDICATE THAT THE STONE HAD TRANSVERSELY CROSSED THE LOWER SEGMENT AND WAS ABLE TO BE EXTRACTED. STONE WAS TOO LARGE FOR THE URETER TO ALLOW IT TO PASS BECAUSE OF ITS FLEXIBILITY.
THE COMPLAINANT INSTITUTION HAS REFUSED TO PROVIDE A SAMPLE OF THE PRODUCT FOR EVALUATION. UPON FOLLOW-UP TELEPHONE INVESTIGATION BY THE IMPORTER/DISTRIBUTOR, THE CLINICIAN WHO ACTUALLY HAD USED THE PRODUCT IN QUESTION, CLEARLY STATED THAT THE INCIDENT WHICH OCCURRED HAD NOTHING TO DO WITH THE PRODUCT. HIS STATEMENT AS RELATED WAS THAT "IT WAS A 4 MM STONE AND IT JUST GOT TWISTED SIDEWAYS THEN GOT STUCK IN THE URETER".
PT ALLEGES RECEIVING BREAST IMPLANTS ON AN UNKNOWN DATE AND OF AN UNKNOWN MFR, AS REPLACEMENTS. PT STATES, "I GO IN ONCE A YEAR TO MY DR FOR A PROCEDURE TO RELEASE THAT SCAR TISSUE THAT BUILDS UP AROUND THE IMPLANTS." REFERENCE MW072401.
PT HAD KNEE REPLACEMENT 7-8 YRS AGO AT ANOTHER FACILITY. DID WELL UNTIL RECENTLY INCREASED PAIN AND EFFUSION. PT ADMITTED FOR SURGERY PROCEDURE SHOWED "WEAR, DELAMINATION, PITTING AND THINNING TIBIAL SIDE. REPLACED TO DIFFERENT SIZE COMPONENT.
H11: BLOCK B6 - MARKED NA. BLOCKED B7 - MARKED NA. BLOCKS D1-D6 DEVICE IDENTIFIED POSITIVELY AFTER A PHYSICIALLY VISITNG FACILITY TO VISUALLY EXAMINE THE SUBJECT DEVICE. USER FACILITY WOULD NOT RELEASE THE IDENTIFIED DEVICE. THIS ALSO RESULTED IN A DELAY OF CO'S RECEIPT OF THE REPORT AS REFECTED IN THE DATE SHOWN IN BLOCK G4. NOTE: THE DEVICE SERIAL NUMBER AND LOT NUMBER WAS NOT VISIBLE AS THE DEVICE WAS STERILIZED, AFTER THE REVISION SURGERY. EVALUATION CODES - "OTHER". METHOD - 86 "OTHER" - FOLLOW-UP WITH  USER FACILITY - VISIT TO PHYSICIAN EXAMINE THE UNIDENTIFIED DEVICE. CONCLUSION: 68 "OTHER" PE WEAR CONSISTENT WITH 7-8 YRS OF IMPLANTATION/USEAGE. CO'S VISUAL EXAM OF THE SUBJECT TIBIAL BEARING INSERT FOUND THE INSERT SHOWED NO SIGN OF ABNORMAL POLYETHYLENE WEAR FOR THE ESTIMATED IMPLANTATION PERIOD. NOTE: THE IMPLANTATION PERIOD WAS REPORTED AS 7-8 YRS. THE SUBJECT DEVICE WAS IMPLANTED 7-8 YRS AGO BY A DIFFERENT USER FACILITY AND SURGEON THAN REFLECTED ON THE ORIGINAL USER FACILITY MED-WATCH REPORT. THE PT WAS REPORTED TO HAVE BEEN EXPERIENCING SOME DISCOMFORT IN THE SUBJECT TOTAL KNEE JOINT. SUBSEQUENTLY, THE ATTENDING PHYSICIAN SCHEDULED AN EXPLORATORY SURGERY BASED ON THE PRELIMINARY DIAGNOSIS OF LOOSENED DEVICES. AT THE REVISION SURGERY, THE PHYSICIAN REPORTEDLY OBSERVED THAT BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED, YET THE SUBJECT TIBIAL BEARING INSERT AND PATELLAR COMPONENT SHOWED EVIDENCE OF WEAR AND WERE SUBSEQUENTLY REPLACED. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE CURRENT PACKAGE INSERT STATES, IN PERTINENT PART, "LOOSENING OF TOTAL KNEE COMPONENT CAN OCCUR. LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATION OR MECHANICAL PROBLEMS WITH THE SUBSEQUENT POSSIBILITY OF BONE EROSION AND OR PAIN". CO'S CURRENT PACKAGE INSERT STATES, "WEAR OF POLYETHYLENE COMPONENTS HAS OCCURRED AND LITERATURE REPORTS HAVE ASSOCIATED ITS OCCURRENCE WITH BONE RESORPTION, LOOSENING AND INFECTION". FINALLY, "ADVERSE EFFECTS MAY NECESSITATE REOPERATION, REVISION, ARTHODESIS OF THE INVOLVED JOINT. GIRDLESTONE OR AMPUATATION OF THE LIMB. DISCLAIMER: SUBMISSION OF INFO BY CO UNDER THE MEDICAL DEVICE REPORTING REGULATION DOSES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFO ACT.
ON 7/11/91 DEVICE WAS IMPLANTED. ON 9/11/95 A CONNECTOR WAS REVISED. ON 9/12/96 THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS -LEAK AT CONNECTOR, PUMP TO RESERVOIR.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCITONAL.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 10/9/80. PT ALSO ALLEGES EXPERIENCING PROBLEMS WITH HARDNESS BEGINNING ON 11/28/80. PHYSICIAN'S NOTE STATES BILATERAL DENSE CAPSULAR CONTRACTURES.
REPORTER ALLEGES PT RECEIVED A SOLID CHIN IMPLANT 20 YRS AGO (I.E. 1976). PHYSICIAN STATES HE HAS A PT WITH LIVER PROBLEMS AND THE ONLY THING SUSPICIOUS IS A CHIN IMPLANT PUT IN 20 YRS AGO.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS BOTH CYLINDERS. ADD'L LOT/SERNO: 7088J 016.
TWO ABUTMENT SCREW FRACTURED FOR THE ABOVE PT. THE MD HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREWS FROM THE IMPLANTS. THE IMPLANTS ARE STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
PT HAD KNEE REPLACEMENT 7-8 YRS AGO AT ANOTHER FACILITY. DID WELL UNTIL RECENTLY, INCREASED PAIN AND EFFUSION. PT ADMITTED FOR SURGERY PROCEDURE SHOWED "WEAR, DELAMINATION, PITTING AND THINNING TIBIAL SIDE." REPLACED TO DIFFERENT SIZE COMPONENT.
INFO RECEIVED ON 9/16/96 INDICATES A REVISION SURGERY WAS PERFORMED, DUE TO AN ON THE JOB INJURY, ON 9/3/96. IT IS UNCERTAIN WHICH, IF ANY, COMPONENTS WERE REVISED.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 9/18/86. PHYSICIAN STATES PT DEVELOPED DISTORTION FROM CAPSULAR CONTRACTURE AND HAS SUSPECTED LEAKAGE. PT ALSO ALLEGES HAVING REMOVAL AND REPLACEMENTS ON 7/23/96, WITH DEVICES OF ANOTHER MFR.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 4/13/76. PT ALSO ALLEGES HAVING NUMEROUS CAPSULATIONS BEGINNING IN 11/76. PT HAD REMOVAL AND REPLACEMENT OF LEFT IMPLANT ON 7/27/81 DUE TO RUPTURE. PHYSICIAN'S NOTE SHOWS PT HAS SCAR ENCAPSULATION, POOR SHAPE AND A POSSIBLE RUPTURED IMPLANT ON RIGHT. REFERENCE MW072396A.
PT ALLEGES RECEIVING A RIGHT BREAST IMPLANT ON 3/10/86. PT ALSO ALLEGES BETWEEN 1986 AND 1996 SHE DEVELOPED OCCASIONAL SHARP PAINS TO START WITH OVER THIS PERIOD. IN 2/96, SHE EXPERIENCED EXTREME PAIN IN THE AREA, RESULTING IN THE REMOVAL OF THE IMPLANT ON 2/29/96. PT HAD A REPLACEMENT WITH A DEVICE OF ANOTHER MFR. PHYSICIAN STATES THE "PROSTHESIS IN RIGHT BREAST RUPTURED" AND UPON REMOVAL THE PROSTHESIS WAS FOUND TO BE RUPTURED IN ITS UPPER PORTION WITH GEL LEAKING INTO THE ENCLOSING CAPSULE.
DEVICE IMPLANTED ON 9/4/91. STEM COMPONENT FRACTURED AND WAS REVISED ON 8/19/96.
THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS TYPE OF EVENT IS NOT OCCURRING WITH GREATER SEVERITY THAN WOULD BE ANTICIPATED. THE FREQUENCY OF OCCURRENCE OF THIS TYPE OF EVENT IS NOT KNOWN. HOWEVER, THE FREQUENCY WITH WHICH THIS EVENT IS OCCURRING IS GREATER THAN HAS BEEN EXPERIENCED WITH OTHER TYPE FEMORAL STEMS SOLD BY CO. THIS MODEL DEVICE HAS NOT BEEN MARKETED SINCE 11/12/92. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT. A FAX WAS SENT TO THE USER FACILITY ON 10/7/96. A MEDWATCH REPORT FORM WAS SENT BY THE USER FACILITY TO CO ON 10/18/96.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 9/28/78. PT ALSO ALLEGES BETWEEN 5/27/93 AND 9/9/94, SHE EXPERIENCED PAIN AND LUMPS NEAR HER STERNUM ON BOTH SIDES AND BETWEEN 3/21/95 AND 3/24/95, SHE DEVELOPED A LARGE LUMP ON THE LEFT SIDE OF HER LEFT BREAST. PHYSICIAN STATES THE PT'S "SILICONE BREAST IMPLANTS WERE LEAKING PRODUCING SILICONE GRANULOMAS OF THE BREAST." PT HAD REMOVAL AND REPLACEMENTS ON 4/6/95, WITH DEVICES OF ANOTHER MFR.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 4/9/87. PT ALSO ALLEGES HAVING DISCOMFORT ON AND OFF SINCE 1987 AND SHE FELT HER IMPLANTS WERE IN THE WAY OF HER UPPER ARMS. SHE HAD A HEAVY FEELING AND WAS CONTINUALLY FEARFUL OF LEAKAGE BETWEEN 1990 AND 1995. PHYSICIAN'S NOTE ALLEGES PT'S PROSTHESES FELT HEAVY AND WERE TOO BIG, CAUSED HER TO BE TENSE IN HER SHOULDERS LEADING TO MUSCLE STRAIN. PT HAD REMOVAL ON 1/5/95.
AS PHYSICIAN WAS WITHDRAWING ARTERIAL SHEATH FROM RIGHT FEMORAL ARTERY AFTER CARDIAC CATH, THE INTRODUCER SHEATH SEPARATED INTO THE SHAFT WHICH REMAINED IN THE PT AND THE SIDE PORT/HEMOSTASIS VALVE. THE PT WENT TO THE OR FOR SUCCESSFUL REMOVAL.
PT ALLEGES RECEIVING A LEFT IMPLANT ON 7/27/81 AS A REPLACEMENT. PHYSICIAN'S NOTE STATES SCAR ENCAPSULATION AND POOR SHAPE. REFERENCE MW072396.
FROM HOSP'S MEDWATCH (8/23/96): "PT ARRIVED TO ER WITH CPR IN PROGRESS; PACER PADS PLACED (ANT/POST POSITION); PT IN V-FIB; DEFIBRILLATED THRU PACER PADS X2 WITHOUT PROBLEMS; ON 3RD DEFIB ATTEMPT AN ELECTRICAL ARC ON ANTERIOR PAD WAS NOTED; AFTER THIS PACER WOULD NOT FUNCITON."
CLARIFICATION OF EVENT DESCRIPTION: "AFTER THIS PACER WOULD NOT FUNCTION." ACCORDING TO THE NURSE INVOLVED IN THE INCIDENT, THIS WAS MEANT TO CONVEY THAT THEY COULD NO LONGER GET A DEFIB SHOCK THROUGH THE PACER PADS. THEY SWITCHED TO THE EXTERNAL PADDLES AND WERE ABLE TO CONTINUE WITH DEFIB SHOCKS. THE PT EXPIRED, BUT ACCORDING TO THE NURSE THE NEED TO SWITCH TO PADDLES HAD NO ADVERSE EFFECT ON THE PT OUTCOME. THE HOSP STAFF FELT THIS WAS ENTIRELY RELATED TO THE PADS AND THE CPR COMPRESSIONS THAT WERE TAKING PLACE. THE DEFIB HAS REMAINED IN SVC SINCE THE EVENT.
A SPRING WIRE GUIDE WAS LEFT IN PT WHEN HE UNDERWENT BYPASS SURGERY IN MARCH OF 1996. THE SPRING WIRE GUIDE WAS VISUALIZED ON X-RAY, BUT NEVER REMOVED. WHEN THE PT RECENTLY EXPERIENCED CHEST PAIN IT WAS DECIDED TO REMOVE THE SPRING WIRE GUIDE. THE DR BELIEVES THE WIRE GUIDE WAS MFG BY CO, BUT HAS NO PROOF.
RPTR ALLEGES PT RECEIVED BREAST IMPLANTS ON AN UNKNOWN DATE AND OF AN UNKNOWN MFR. RPTR ALSO ALLEGES PT HAS LEAKAGE IMPLANTS.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 2/27/79. PT ALSO ALLEGES IN 1994 SHE DEVELOPED DRY EYES AND MOUTH AND HARDENING OF HER BREAST. PHYSICIAN STATES BOTH OF THE PT'S BREASTS HAD BECOME HARD WITH CONTRACTURES AND SENSATION IN THE BREASTS. PT HAD REMOVAL AND REPLACEMENTS ON 7/20/95, WITH DEVICES OF ANOTHER MFR.
HEALTHCARE PROFESSIONAL REPORTED CALCIFICATION/CUSPAL STIFFENING AND THAT THE VALVE WAS REMVED DUE TO ENDOCARDITIS THAT HAD DESTROYED THE VALVE. ORGANISM-STREPTOCOCCUS. ECHO PRIOR TO EXPLANT REVEALED STENOSIS AND CENTRAL REGURGITATION. VALVE IMPLANTED FOR 7 MONTHS PT 54 YRS OLD.
SUBMISSION OF INFO BY CO UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY THEREFORE, INFO ON THIS MEDWATCH FORM 3500A WAS COMPLETED BY CO WITH INFO RECEIVED FROM THE HEALTHCARE PROFESSIONAL. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A. H3 ANALYSIS: THE RIGHT AND LEFT CUSPS ARE VERY STIFF, THE NON-CORONARY CUSP IS STIFF BUT FLEXIBLE. TISSUE DETERIORATION THAT IS ASSOCIATED WITH VISIBLE MINERALIZATION IS NOTED ON THE INFLOW AND OUTFLOW OF THE VALVE. A LIGHT TAN, GRANULAR MATERIAL IS NOTED ALONG THE COAPTIVE RIDGES OF ALL CUSPS. BROWN, FRIABLE, VEGETATIVE APPEARING MATERIAL IS NOTED ON THE INFLOW AND OUTFLOW OF THE VALVE AND FILLS THE RIGHT CUSP. THE RADIOGRAPHS SHOW MODERATE TO EXTENSIVE MINERALIZATION AT ALL COMMISSURES THAT EXTEND TO THE LUNULAE OF ALL CUSPS WITH SMALL AREAS MID RIGHT AND NON-CORONARY CUSPS.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECT RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. POST OP VISUAL BY THE PHYSICIAN NOTED THE LEAD TO BE NOT FRACTURED.
ON 9/19/96, THE MFR RECEIVED A REPORT FROM ITS DISTRIBUTOR WHICH STATES THAT A FACILITY IN THEIR TERRITORY DISCOVERED THE SNAP-LOCK CONNECTOR TO BE MISSING UPON OPENING THE DEVICE PACKAGE. FURTHER COMMUNICATION WITH THE FACILITY BUYER, ON 9/26/96, REVEALED THAT SURGERY WAS PROLONGED FOR APPROX 20 MINS UNTIL ANOTHER DEVICE WAS OBTAINED.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: THE ORIGINAL DEVICE WAS USED TO SHIP THIS UNIT. THE BOX CONTAINED A SUBLCAVIAN INTRODUCER SET IN THE ORIGINAL SEALED PACKAGE. ALL ITEMS WERE PRESENT AND APPEARED UNUSED. THE POLYSULFONE VASCULAR ACCESS DEVICE, A 22GA HUBER POINT NEEDLE AND 8 FR SILICONE CATHETER WERE INSIDE THE ORIGINAL OPENED PACKAGE. THE SNAP-LOCK CONNECTOR WAS NOT INCLUDED. AS PART OF CO'S INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CAT AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE CUSTOMER'S REPORT OF A MISSING SNAP-LOCK CONNECTOR HAS BEEN CONFIRMED; HOWEVER, BASED ON THE INFO AVAILABLE, AND THE DEVICE ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
DURING A DCA PROCEDURE, A DISSECTION HAD OCCURRED IN THE PT'S LEFT MAIN. THE PT WAS SENT TO SURGERY AND WAS INITIALLY REPORTED AS HIGH-RISK. THE PT SUBSEQUENTLY EXPIRED ONE MONTH POST-OP. DISSECTION HAD OCCURRED 48 HOURS POST MI IN A HIGH RISK PTCA. PHYSICIAN DID NOT INDICATE WHAT DEVICE CONTRIBUTED TO DISSECTION. IT IS UNKNOWN IF A DEVICE MALFUNCTION HAD OCCURRED. THE DEVICE WAS DISCARDED BY THE ACCOUNT.
PT ALLEGES RECEIVING A RIGHT BREAST IMPLANT ON 12/6/85. PT ALSO ALLEGES IMTERMITTENT PAIN ON A REGULAR BASIS, CONTRACTION, TIGHTNESS, LOOKS DEFORMED AND HER SCARS HAVE GONE HARD. ALL SYMPTOMS OCCURRED AND ARE STILL OCCURRING SINCE INSERTION. PHYSICIAN STATES PT HAS "RIGHT BAKER II/III CONTRACTURE, PROSTHESTIC DISTORTION AND MALPOSITION, TIGHTNESS AND SOME PAIN INTERMITTENTLY". PT'S REMOVAL WAS PROPOSED TO BE IN OCTOBER/NOVEMBER, 1996.
SPOUSE REPORTS THAT BRITTLE DIABETIC ALLEGES DEVICE READING HIGHER THAN ACTUAL. RECALLS INCIDENT WHEN BLOOD GLUCOSE READING WAS 203 MG/DL, WENT BACK TO DOING YARD WORK AND WAS FOUND PASSED OUT BY WIFE.
SECTION H3-EVAL SUMMARY: THE SECTION OF J STIFFENER WIRE REC'D MEASURES APPROX 82MM WITH NO OTHER PORTION OF THE J STIFFENER WIRE REC'D ALONG WITH NO ANODE BAND/WELD SITE REC'D THEREFORE UNABLE TO DETERMINE THE LOCATION OF THE FRACTURE FROM THE WELD SITE. IT APPEARS THAT ~6MM OF THE J STIFFENER WIRE WAS NOT REC'D WITH ALL RECORDED ADDING UP TO APPROX 82MM. X-RAY OF THE PARTIAL PORTION OF LEAD REC'D ALONG WITH THE APPROX 82MM PORTION OF J STIFFENER WIRE REC'D CONFIRMS THAT NO OTHER PORTION OF THE J STIFFENER WIRE WAS REC'D AND CONFIRMS NO OTHER DISCREPANCIES CONCERNING THE APPROX 82MM PORTION.
THE SYRINGE THAT ACCOMPANIES THE DEVICE "BROKE" WHILE THE PRODUCT WAS BEING MIXED. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN THE LABELING: N. "SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION".
CO, AS THE MFR OF THIS DEVICE, BECAME AWARE OF AN EVENT ON 9/19/96, INVOLVING TWO 20FR GUIDEWIRE STICK PEG FEEDING TUBES. IN BOTH CASES, THE PEGS WERE PLACED WITHOUT INCIDENT. ONE PT DEVELOPED AN INFECTION AT THE INSERTION SITE. THE OTHER PT PHYSICALLY REMOVED THE DEVICE. AN ATTEMPT TO REINSERT THE SAME DEVICE RESULTED IN THE DEVELOPMENT OF THE INFECTION. BOTH PTS WERE PLACED ON ANTIBIOTICS, ANOTHER MFR'S FEEDING DEVICE WERE PLACED SUCCESSFULLY AND THEIR CONDITION IS REPORTED AS 'DOING FINE'. SEVERAL ATTEMPTS TO GAIN FURTHER INFO BY THE DISTRIBUTOR AND THE MFR HAVE BEEN UNSUCCESSFUL. THEREFORE, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE CIRCUMSTANCES SURROUNDING THESE EVENTS. THE INSTRUCTIONS FOR USE FOR THIS DEVICE STATE: "AVOID EXCESSIVE PULLING ON THE FEEDING TUBE AS THIS MAY CAUSE THE INTERNAL BOLSTER TO EMBED AGAINST THE GASTRIC MUCOSA. THE RESULT CAN BE TISSUE NECROSIS, TUBE MIGRATION, INFECTION AND ASSOCIATED SEQUELAE. TUBING SHOULD BE MONITORED FOR POSSIBLE MIGRATION IN ACCORDANCE WITH INSTRUCTIONS. TUBE MIGRATION COULD RESULT IN THE FOLLOWING: INABILITY TO FEED, PERITONITIS, INFECTION AND ASSOCIATED SEQUELAE. THE BOLSTER SHOULD BE ROTATED FOR SITE HYGIENE. THE STOMA SITE SHOULD BE CLEAN AND DRY AT ALL TIMES."
THIS INFO SHALL NOT BE CONSTRUED AS AN ADMISSION BY APPLIED MEDICAL TECHNOLOGY THAT THE PRODUCT(S) DESCRIBED HEREIN ARE OR WERE DANGEROUS IN ANY RESPECT, OR THAT ANY CASUAL RELATIONSHIP EXISTS BETWEEN THESE PRODUCTS AND ANY ACTUAL OR POTENTIAL INJURY. IN ADDITION, THE SUBMISSION OF A REPORT BY APPLIED MEDICAL TECHNOLOGY SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 7/79. PT ALSO ALLEGES THAT FOR APPROX. TWO TO THREE YRS (I.E. 1993) HER LEFT IMPLANT WAS GIVING HER MUCH DISCOMFORT; THEREFORE, SHE HAD REMOVAL OF BOTH IMPLANTS ON 4/12/96. HER LEFT IMPLANT WAS LEAKING WITHOUT HER KNOWLEDGE AND AT THE SAME TIME SHE WAS HAVING MASSIVE CHEST PAINS. SHE IS PRESENTLY SEEING HER EYE DR DUE TO COMPLICATIONS TO HER EYE SIGHT IS DUE TO HER IMPLANTS.
ON PORTABLE ABDOMINAL X-RAY, A METALLIC WIRE WITHIN THE REGION OF THE LT GROIN WAS NOTED. PT WAS TAKEN TO ANGIOPLASTY FOR RETRIEVAL OF THE RETAINED WIRE FRAGMENT. THIS WAS IN COMMON ILIAC VENOUS SYSTEM. THERE WAS THROMBUS INVOLVING THE COMMON ILIAC VEINS.
MOTHER OF TYPE I DIABETIC REPORTS TESTING CHILD BEFORE DINNER AND GIVING INSULIN BASED ON RESULT USING SLIDING SCALE. TESTED AFTER SNACK AND GOT A READING OF 73 MG/DL. PT FELT AS IF SHE HAD LOW BLOOD GLUCOSE, TRIED TO TEST BUT GOT AFTER DOSING STRIP ERROR (INDICATIVE OF INCORRECT BLOOD DROP). PT HAD A SEIZURE, PARAMEDICS WERE CALLED. MOTHER GAVE DAUGHTER ANOTHER SNACK. BLOOD GLUCOSE TESTED BY PARAMEDICS AS 71 MG/DL.
100: FAILSAFE SETTING WAS OVERLY SENSITIVE. 68: FAILSAFE SETTING HAS BEEN WIDENED TO REDUCE OCCURRENCE OF STRIP ERRORS.
CATHETER INSERTED 4/15/96. PT EXPERIENCED PAIN AND BURNING DURING CHEMOTHERAPY INFUSION THROUGH THE CATHETER. REMOVED CATHETER 9/9/96. A SMALL RUPTURE OR BREAK IN THE CATHETER WAS OBSERVED.
CONSUMER REPORTS THAT SHE EXPEREINCED A TOXIC CHEMICAL REACTION WHILE USING PRODUCT. OPHTHALMOLOGIST REPORTS PT EXPERIENCED SUDDEN INTENSE LIMBAL INFLAMMATION, EPITHELIOPATHY, FOLLOWED BY BILATERAL SLOUGHING OF CORNEAL EPITHELIIUM AND DELAYED WOUND HEALING. INITIAL OBSERVATION OF LID EDEMA AND CHEMOSIS, CORNEAL ABRASIONS APPEARED CONSISTENT WITH CHEMICAL KERATITIS. EVENT WAS TREATED WITH VOLTAREN, OCUFLOX, CYCLOPLEGIA WITH HYOSINE 1/4% AND HOMATROPINE. WHEN REEPITHELIALIZATION OCCURRED TREATMENT WITH INFLAMASE FORTE Q2H WAS INITIATED. OTHER THERAPEUTIC PROCEDURES UTILIZED INCLUDE BILATERAL PRESSURE PATCHING AND A THERAPEUTIC CONTACT LENS OS. TAROSORRHAPHY OS IS BEING CONSIDERED. DOCTOR REPORTS A LIMBAL CONJUNCTIVAL  AUTOGRAFT MAY BE REQUIRED.
EVALUATION OF RETURNED PRODUCT REVEALED NO PRODUCT FAILURE AND PRODUCT MET SPECS. NUMBER OF PERSONS INVOLVED = 1. THIS REPORT WAS MAILED IN TO FDA ON: 10/16/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN CO PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
ON 9/2/96, AN B-HCG ASSAY WAS RUN ON A PT SCHEDULED FOR A TUBAL LIGATION AND GAVE A RESULT OF 120 MLU/ML, WHICH WAS REPORTED OUT. BASED ON THIS RESULT, THE TUBAL LIGATION WAS CANCELLED AND THE PT WAS REDRAWN. THIS SAMPLE WAS TESTED AT ANOTHER LAB FOR B-HCG AND A NEGATIVE RESULT WAS OBTAINED. THE ORIGINAL SAMPLE WAS THAN RETESTED ON THE DEVICE AND ALSO GENERATED A NEGATIVE RESULT. THE PROCEDURE FOR A TUBAL LIGATION WAS THAN RESCHEDULED. NO REPORT OF INJURY.
INVESTIGATION SUMMARY: THE EVENT REPRESENTED IS NOT ADDRESSED IN THE DEVICE LABELING. A MALFUNCTION DID OCCUR. THIS REPORTABLE MDR EVENT WAS INVESTIGATEDAS PART OF AN ONGOING STUDY OF THE AXSYM SYSTEM BY ABBOTT INTO THE CAUSATIVE REASON FOR MALFUNCTIONS. RESULTS OF THE INVESTIGATION YIELDED A NUMBER OF SYSTEM ENHANCEMENTS IMPLEMENTED ON CUSTOMER UNITS. IMPROVEMENTS INCLUDED AXSYM SYSTEM SOFTWARE VERSION 3.0 WITH ENHANCED ALGORITHM FOR FLUID DETECTION, NEW BUFFER TUBING AND SEAL FITTINGS WHICH REDUCED BUBBLES FORMING IN TUBING LINES, MODIFICATIONS TO THE LIQUID LEVEL SENSE BOARD TO DECREASE SENSITIVITY OF THE INSTRUMENT TO ELECTROSTATIC DISCHARGE, AND PACKAGING MODIFICATIONS FOR ADDED PROTECTION AND PROBES. IN ADDITION, ABBOTT HAS EMPHASIZED TO OUR CUSTOMERS THAT CORRECT OPERATING PROCEDURES MUST BE FOLLOWED TO ENSURE OPTIMAL PERFORMANCE OF THE AXSYM SYSTEM. AREAS  THAT WERE EMPHASIZED INCLUDED PROBE CRASH RECOVERY PROCEDRUE, RECOMMENDED TUBE SIZES AND TYPES, OPENING REAGENT BOTTLE 4, PROPER LOADING/UNLOADING OF REAGENT PACKS, AND ENSURING PROPER SAMPLE AND REAGENT HANDLING. THIS IS THE FINAL REPORT.
THE PORTAL WAS RETURNED WITH AN 8 INCH LENGTH OF CATHETER ATTACHED. MICROSCOPY EXAMINATION REVEALED A 1/8TH INCH SLIT ALONG THE LENGTH OF THE CATHETER OVER THE PORTAL OUTLET TUBE. THE ORIENTATION AND PHYSICAL CHARACTERISTIC OF THE SLIT IS CONSISTENT WITH A MECHANICAL FAILURE OF UNKNOWN CAUSE.
THE LEAD WAS EXPLANTED ELECTRIVELY. FAILURE ANALYSIS INDICATES COIL WIRE FRACTURES.
THIS ENTIRE FORM COMPLETED BY MFR. LEAD REC'D WITH OPEN RESISTANCE ON ANODE PORTION OF LEAD ALONG WITH NO DISCREPANCIES CONCERNING J STIFFENER WIRE. VISUAL INSPECTION INDICATES ANODE COIL WIRE FRACTURES 29 CM DISTAL TO PROXIMAL TERMINAL PIN. VISUAL INSPECTION UNDER 30X MAGNIFICATION AND X-RAY OF J STIFFENER WIRE INDICATES NO DISCREPANCIES.
A TYPE I DIABETIC REPORTS HAVING INSULIN REACTION WITH USE OF DEVICE. PT ALLEGES OVERTREATMENT WITH INSULIN (SLIDING SCALE) BECAUSE DEVICE READS HIGHER THAN ACTUAL. SPOUSE USED GLUCAGON KIT TO TREAT PT AFTER INSULIN REACTION.
THE ANTISEPTIC SURFACE CATHETER WAS INSERTED INTO A FEMALE PT IN THE OR. HER BLOOD PRESSURE DROPPED AND THE OPERATION WAS STOPPED. IT WAS DISCOVERED THAT IT HAD PREVIOUSLY BEEN DETERMINED THAT THE PT WAS ALLERGIC TO CHLORHEXIDINE, A COMPONENT OF THE ANTISEPTIC CATHETER TREATMENT. THE PHYSICIAN OVERLOOKED THIS PT'S SENSITIVITY. THE PT RECOVERED WITHOUT ANY COMPLICATIONS. THE SURGERY WAS COMPLETED USING A NON-CO'S CATHETER.
CO'S INVESTIGATION OF THIS INCIDENT THROUGH A DETAILED SEARCH OF THE LITERATURE PERTAINING TO THE SUBJECT DISCLOSED THAT INDIVIDUALS ARE KNOWN TO HAVE HAD IMMEDIATE HYPERSENSITIVE REACTIONS FOLLOWING TOPICAL CHLORHEXIDINE ADMINISTRATION. A COMPONENT OF THE ANTISEPTIC CATHETER SURFACE TREATMENT IS CHLORHEXIDINE. CO SUSPECTS THAT THIS PT MAY HAVE BEEN HYPERSENSITIVE TO THE ANTISEPTIC SURFACE TREATMENT. ALTHOUGH. CO HAS ONLY RECENTLY BECOME AWARE OF THIS SITUATION THROUGH A FEW INCIDENT REPORTS, CO HAS DECIDED TO REVISE THE PRODUCT LABELING TO CONTRAINDICATE THE CATHETER FOR PTS WITH KNOWN SENSITIVITY TO CHLORHEXIDINE. AS AN IMMEDIATE ACTION, CO IS IMPLEMENTING THE FOLLOWING ADDITIONS, EFFECTIVE 1/1/96. 1. A CONTRAINDICATION STICKER WILL BE PLACED PROMINENTLY ON THE UNIT PACKAGE LIDSTOCK OF ALL PRODUCTS, WHICH READS AS FOLLOWS: "THE ANTISEPTIC SURFACE CATHETER IS CONTRAINDICATED FOR PTS WITH KNOWN HYPERSENSITIVITY TO CHLORHEXIDINE (REFER TO PRODUCT INSTRUCTIONS FOR REFERENCES)." 2. A SUPPLEMENT TO THE INSTRUCTION BOOKLET IN THE FORM OF A YELLOW CARD WITH RED PRINTING WILL BE INCLUDED INSIDE THE TOP OF EACH INDIVIDUAL ANTISEPTIC PRODUCT PACKAGE, WHICH READS AS FOLLOWS: _THE ANTISEPTIC SURFACE CATHETER IS CONTRAINDICATED FOR PT WITH KNOWN HYPERSENSITIVITY TO CHLORHEXIDINE. RARE, ISOLATED CASES OF HYPERSENSITIVE REACTIONS TO ANTISEPTIC SURFACE HAVE BEEN REPORTED IN JAPANESE PTS IN JAPAN ONLY (FIRST CASE REPORTED MAY 1996). THE LITERATURE INDICATES THAT INDIVIDUALS OF JAPANESE EXTRACTION ARE KNOWN TO HAVE HAD IMMEDIATE HYPERSENSITIVE REACTIONS FOLLOWING TOPICAL CHLORHEXIDINE ADMINISTRATION. IF ADVERSE REACTIONS OCCUR AFTER CATHETER PLACEMENT, REMOVE CATHETER IMMEDIATELY.
AN X-RAY SHOWED A METALLIC WIRE IN THE REGION OF THE LT GROIN. THE PIECE OF WIRE WAS RETRIEVED WITH NO PT COMPLICATIONS. THE PT HAD BEEN ADMITTED ON 7/27/96 FOR INJURIES FROM A DIVING ACCIDENT, AND HAD A C5-C6 FRACTURE AND PARAPLEGIA.
THE SAMPLE RETURNED WAS ONLY A SMALL PORTION OF THE SPRING WIRE GUIDE. THE RETURNED 6" SEGMENT IS THE OUTER COIL WIRE THAT WAS CUT BY THE USER AT THE ONE END. THE BALL WELD IS STILL ATTACHED TO THE COIL AND THE CORE WIRE HAS SEPARATED ADJACENT TO THE WELD. THERE IS NO INDICATION OF ANY MFG OR MATERIAL DEFECT. THE SEPARATION OF THE WIRE GUIDE APPEARS TO BE DUE TO USER ERROR.
DURING A POSTERIOR VITRECTOMY PROCEDURE, THE VITRECTOMY CUTTER ON THIS OPHTHALMIC MICROSURGICAL SYSTEM WOULD NOT CLOSE AND IOP SETTING HAD TO BE INCREASED FROM THE NORMAL SETTING OF 30 MM HG TO 60 MM HG IN ORDER TO ACHIEVE DESIRED RESULTS.
SECTIONS A-F WERE COMPLETED BY THE MFR. THE OUTPUT OF THE VITRECTOMY VALVE WAS LOW BUT STILL WITHIN SPECS. IT WAS REPLACED. THE REGULATOR WAS ADJUSTED AS IT WAS READING 59.4 PSI.
PT UNDERWENT CATARACT SURGERY ON 9/19/96, AND IMPLANTATION OF A MODEL AA-4203V INTRAOCULAR LENS WAS ATTEMPTED BT THE SURGEON. HOWEVER, AS HE INSERTED THE LENS INTO THE PT'S EYE IT WENT THROUGH THE POSTERIOR CAPSULE. THE SURGEON WAS NOT SURE IF THE POSTERIOR CAPSULE WAS TORN PRIOR TO LENS INSERTION. DURING EXPLANTATION THE SURGEON TORE THE LENS AND HE PERFORMED AN ANTERIOR VITRECTOMY. NO OTHER SURGICAL PROCEDURES WERE DONE AND NO COMPLICATIONS WERE NOTED.
H6-CONCLUSION-THE LENS WAS MOST LIKELY UNDER LUBRICATED IN THE CARTRIDGE LOADING AREA. THIS WOULD CAUSE THE INJECTOR PLUNGER TO OVERRIDE THE HAPTIC DURING INSERTION. THE PT'S VISUAL ACUITY WAS 20/200 UNCORRECTED WITH PINHOLE AT HIS LAST EXAM. THIS HAS IMPROVED FROM 20/400 PREOPERATIVE. THE SURGEON WAS NOT SURE IF THE POSTERIOR CAPSULE TEAR WAS A RESULT OF THE LENS SYSTEM. THE PT'S LAST FOLLOW-UP EXAM WAS 10/08/96 WHERE THE SURGEON OBSERVED SOME CORNEAL EDEMA. THE SURGEON STATED THAT THE PT'S PROGNOSIS IS IMPROVING. THE ABOVE REFERENCED LENS BOX WAS RECEIVED. THE BOX CONTAINED 8 CHART LABELS, THE PT ID CARD, REGISTRATION CARD, CO PRODUCT INFO BOOKLET, LENS POUCH, AND A POUCH. THE POUCH CONTAINED THE LENS TRAY. THE LENS TRAY CONTAINED THE TOP AND BASE INSERTS, WITH THE LENS LOCATED IN BETWEEN THE INSERTS. TAPE WAS HOLDING THE LENS AND INSERTS WITHIN THE TRAY. THE LENS WAS REMOVED FROM THE TRAY AND INSPECTED FOR DEFECTS THAT MAY HAVE CAUSED THE LENS TO TEAR DURING REMOVAL. THE LENS WAS RECEIVED IN TWO PIECES, HAVING DRIED BSS/VISCOELASTIC RESIDUE. THE PIECES DO NOT COMPLETE A LENS. EXPLANTATION MAY HAVE CAUSED SOME OF THE DAMAGE. HOWEVER, LENS DAMAGE USUALLY OCCURS IF THE INJECTOR PLUNGER RIDES OVER THE HAPTIC DURING INSERTION. THE LENS MUST BE INCARCERATED FOR THIS TO OCCUR. THE LENS WAS MOST LIKELY MISLOADED OR UNDER LUBRICATED IN THE CARTRIDGE LOADING AREA.
A MEDICAL PROFESSIONAL REPORTS A TYPE II DIABETIC PT WAS ADMITTED TO STABILIZE HER BLOOD GLUCOSE READING BY TREATMENT OF IV INSULIN. PT'S DEVICE GAVE BLOOD GLUCOSE RESULT OF 24 MG/DL WHILE AT HOME. SINCE FEELING ILL WITH NAUSEA WENT TO ER. NURSE CLEANED PT DEVICE AND GOT BLOOD GLUCOSE READING OF 300 MG/DL. ER DEVICE READING FOR BLOOD GLUCOSE WAS HI AND LAB ANALYSIS WAS 600+.
THE UNIT PUMPED 10% OVERFILL OF POTASSIUM. EVENT INVOLVED A 47 KG CHILD. PT RECEIVED ALMOST ALL THE SOLUTION AND THE EVENT WAS NOTICED 24 HRS LATER WHEN THE LAB REPORTED AN ELEVATED SERUM POTASSIUM. THE PT IS REPORTED TO BE DOING FINE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION. THE UNIT ALSO HAS A P-26 ERROR WHICH OCCURRED WHEN THE USER WAS STARTING A NEW BAG.
SECTION F WAS COMPLETED BY CO BASED ON INFO PROVIVED BY THE REPORTER. EVALUATION: THE UNIT WAS RECEIVED DIRTY AND CONTAINED LOOSE OBJECT. IT WAS TESTED AS RECEIVED. THE UNIT PASSED ALL PERFORMANCE TESTS. LOOSE COMPONENT WAS IDENTIFIED AS A HEX NUT AND WAS LEFT IN THE LOCATION FOUND. THE COMPLAINT COULD NOT BE DUPLICATED. A FEW CC OF ACTUAL TPN ADMIXTURE INFUSED ON THE PT WAS RETURNED TO CO FOR EVAL. TEST RESULT SHOWED THE ADMIXTURE CONTAINED 104 MEQ/L OF POTASSIUM COMPARED WITH 106.4 MEQ/L-THE THEORETICAL EXPECTED VALUE. THE HOSPITAL HAD REPORTED THEIR LABORATORY OBTAINED A VALUE OF 116 MEQ/L OF POTASSIUM IN THE SAMPLE. CO'S TEST RESULTS SHOWED THE COMPOUNDER PERFORMED ACCORDING TO SPECIFICATION.
AN INFANT RESUSCITATION SUPPORT DEVICE WAS TAKEN OUT OF ITS PLASTIC CONTAINER AND MADE READY FOR USE ON AN ADULT PT. WHEN USED IT CAUSED MAJOR COMPLICATIONS. THE PT HAD TO BE TREATED FOR A TENSION PNEUMOTHORAX. IT WAS FOUND THAT THE BAG PORTION OF THE DEVICE WAS INSERTED INTO THE TUBING BACKWARDS (VALVE END).
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (CO EFFECTIVE DATE, FEB. 10, 1992). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21CFR803. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO BE PROVISION OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION".
THE PATIENT WAS IMPLANTED WITH A DEVICE WITH REMOTE INJECTION SITE PROSTHESIS ON 8/29/96. ON 9/7/96 THE PHYSICIAN NOTED THAT THE PATIENT HAD DEVELOPED A SEROMA, HEMATOMA, INFECTION, MASSIVE SWELLING, NECROSIS, AND THE DEVICE WAS LEAKING. NO ADDITIONAL INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
DATE OF ORIGINAL SURGERY WAS 1989. REVISION SURGERY WAS PERFORMED ON 9/12/96, DUE TO FRACTURE OF STEM.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT.
RPTR HAD 2 EMPLOYEES THAT HAD EXPOSURE TO DETERGENT VAPORS AND HAD ACUTE RESPIRATORY DISTRESS. ONE EMPLOYEE WENT TO EMERGENCY DEPT FOR RELIEF OF SYMPTOMS. DATE OF EVENT IS APPROX. EVENT DISCOVERED IN CONVERSATION WITH PERSON AT USER FACILITY.
DATE SENT TO FDA: 10/18/96. HAD 2 EMPLOYEES THAT HAD EXPOSURE TO VAPORS AND HAD ACUTE RESPIRATORY DISTRESS. ONE EMPLOYEE HAD FIRST SYMPTOMS ABOUT 6 MONTHS AGO, AND SECOND EMPLOYEE HAD SYMPTOMS ABOUT JULY OF THIS YEAR. THIS IS THE FIRST TIME THAT CO HAD LEARNED OF THIS OCCURRENCE. BOTH EMPLOYEES HAVE NEEDED TO SEEK MEDICAL ATTENTION. THE ACCOUNT HAS SUBSEQUENTLY REMOVED QUESTIONABLE PRODUCTS. NO FURTHER EMPLOYEE EVENTS HAVE OCCURRED SINCE DISCONTINUATION OF THESE PRODUCTS AND EMPLOYEES NOT ASSIGNED TO WORK IN THESE AREAS. IT WAS REPORTED THAT THE FIRST EMPLOYEE DEVELOPED MILD RESPIRATORY SUYMPTOMS SUCH AS COUGHING, HEADACHE, DYSPNEA, AND SINUS INFECTIONS AFTER EXPOSURE TO PRODUCTS OF THIS TYPE NOT MFG OR DISTRIBUTED BY CO. THESE CHEMICALS WERE DISCONTINUED AND CO PRODUCT USE WAS INITIATED. THE SAME EMPLOYEE DEVELOPED SIMILAR SYMPTOMS AFTER CO PRODUCT WAS INTRODUCED. AND A SECOND EMPLOYEE NOT AFFECTED BY THE NON CO'S PRODUCT HAD SEVERE RESPIRATORY SYMPTOMS AFTER EXPOSURE TO CO'S PRODUCT REQUIRING EMERGENCY ROOM VISIT, GIVEN MEDICATIONS FOR REVERSAL OF SYMPTOMS, AND MISSED SEVERAL DAYS WORK. SYMPTOMS OF THIS EPISODE INCLUDED DYSPNEA, THROAT SWELLING, AND GAGGING. THIS EVENT WAS CONSIDERED AN ASTHMATIC EPISODE, AS REPORTED BY CALLER. THIS COMPLAINT OPENED FOR MDR DETERMINATION AND REPORTING. NO SAMPLE IS AVAILABLE.
THE SALINE DEVICE WAS RECEIVED BY THE DR WITH IN THE INNER SEAL FOUND. "BREACHED" BEFORE SURGERY. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING?N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING?N. IF "N", IS EVENT GREATER SEVERITY THAN USUAL FOR PRODUCT? U. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO.
EVALUATION: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
EVENT COMPLICATIONS: UNK - RPT'D 9/16/96. PT CURRENT STATUS: UNK - RPT'D 9/16/96.
ALLEGEDLY REVISION SURGERY WAS PERFORMED DUE TO ANTERIOR TIBIAL KNEE PAIN. AT REVISION, ALLEGEDLY THE TIBIAL BASE WAS LOOSE WITH NO CEMENT ADHERENCE. ALL OTHER COMPONENTS ALLEGEDLY WERE STABLE, WELL FIXED.
CONCLUSION STATEMENT: NO DEVICE FAILURE. THREE CONTACTS WITH USER FACILITY HAVE BEEN MADE AND DOCUMENTED REQUESTING MEDWATCH FORM. NO RESPONSE HAS BEEN RECEIVED.
REPORT RECEIVED OF J RETENTION WIRE FRACTURE WITH PROTRUSION. PPT DIED POST OPERATIVE DUE TO LEAD EXTRACTION COMPLICATIONS. NO ADD'L INFO IS AVAILABLE.
SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. CO EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSABLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION: PURSUANT TO INFO RECEIVED FROM THE PHYSICIAN, THE PT WAS BILATERALLY IMPLANTED WITH CO SALINE DEVICES ON 5/13/96. ON 6/29/96 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION IN THE LEFT BREAST AND NOTED LYMPHADENOPATHY IN THE RIGHT BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
ADD'L INFO TO BE SUBMITTED Y/N? Y. IS THE EVENT FREQUENCY ADDRESSED IN THE PRODUCT LABELING? N. IF "YES",IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN THE LABELING? IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" CO'S EFFECTIVE DATE, FEBRUARY 10, 1992). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILLING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER EVENTS 21CFR803.
DURING A HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT LOCK PROPERLY. THE HOSP HAS REPORTED NO FURTHER INFO.
12/17/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
DURING THE PROCEDURE THE LASER BEGAN TO LOSE POWER (AS INDICATED ON CONSOLE DISPLAY). IT APPEARED AS THOUGH THE POWER DROPPED FROM 250 MW TO 100 MW THEN TO 25 MW. THE TECH AT THE CONSOLE INCREASED THE POWER ATTEMPTING TO CORRECT, EVEN THOUGH THE DR WAS STILL GETTING EXPECTED RESULTS. THE RESULTS OF CO'S SERVICE CALLL FOUND THAT A PCB MALFUNCTIONED AND CAUSED THE DISPLAY TO INDICATE A DROP IN POWER, WHEN IN REALITY THERE WAS NO DROP IN POWER. THE DR HAD TO STOP BLEEDING, BUT PROCEEDED WITH SURGERY. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.
FREQUENCY OF OCCURRENCE NOT ADDRESSED IN LABELLING. IT IS UNKNOWN IF FREQUENCY IS GREATER THAN USUAL. SEVERITY OF OCCURRENCE NOT ADDRESSED IN LABELLING. IT IS UNKNOWN IF SEVERITY IS GREATER THAN USUAL.
DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE INSTRUMENT BROKE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/15/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. CO FOREIGN SUBSIDIARY WAS INFORMED OF THIS EVENT ON 8/27/96. HOWEVER, CORPRATE WAS NOT INFORMED UNITL 10/3/96. CO'S FOREIGN SUBSIDIARY WILL BE RE-INSTRUCTED REGARDING THE MFR REGULATION.
ALLEGED INFECTION. FOLLOW-UP FINDINGS: AS PER PHYSICIAN ETIOLOGY OF ONFECTION UNKNOWN.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CO THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF CO'S EVALUATION OF THE DEVICE. CO'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. FILING A MDR DOES NOT CONSTITUTE AN ADMISSION BY CO THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. REPORTS ARE BASED ON INFO SUPPLIED TO CO AND THE SUBSEQUENT INVESTIGATION. CO CONSIDERS THIS INFO TO BE HIGHLY CONFIDENTIAL AND, THEREFORE, PROTECT IT FROM ANY REQUEST, PURSUANT TO 21 CFR PART 803.9 (B). DEVICE EVALUATION METHOD CODE 86= DEVCE WAS NOT RETURNED FOR EVALUATION.
ON OR ABOUT 8/19, THE PT OBTAINED A METER READING OF 66 MG/DL ON HIS METER. APPROX TWO HRS LATER, WHILE WORKING OUTSIDE, THE PT BEGAN TO FEEL BAD, "THOUGHT IT WAS HIS HEART." HE WAS TRANSPORTED TO THE HOSP WHERE A BLOOD GLUCOSE RESULT OF "440" WAS OBTAINED (METHOD UNKNOWN). THE PT WAS HOSPITALIZED FOR SIX DAYS FOR TREATMENT OF ELEVATED GLUCOSE (TREATMENT UNKNOWN). IT WAS REPORTED THAT THE PT WAS DIAGNOSED WITH ELEVATED GLUCOSE IN 1992 AND BEGAN USING THE SUBJECT METER AT THAT TIME. HE TOOK INSULIN (AMOUNT UNKNOWN) FOR A SHORT TIME. HIS GLUCOSE LEVEL ALLEGEDLY RETURNED TO NORMAL AND THE MEDICATION WAS CEASED. SINCE HOSPITALIZATION, THE PT IS AGAIN TAKING INSULIN ON A DAILY BASIS (AMOUNT UNKNOWN). THE RPTR DECLINED PROVIDING ANY INFO REGARDING METER MAINTENANCE AND CALIBRATION STATUS. IT WAS REPORTED, HOWEVER, THAT A TEST STRIP IS STORED OUTSIDE OF THE VIAL IN THE METER CASE FOR CONVENIENCE SAKE. IT IS UNKNOWN IF AN EXPOSED TEST STRIP WAS USED TO OBTAIN THE GLUCOSE RESULT ON THE DAY OF THE ALLEGED EVENT.
THE CO HAS COMPLETED ITS INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. TEH CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER STORAGE OF TEST STRIP PRODUCT, OR SOME UNK ANOMALY. AT THIS POINT THE CO'S INVESTIGATION OF THIS MATTER IS CLOSED.
DURING PORT IMPLANT THE CATHETER WAS BLOCKED. THE SURGEON IMPLANTED A NEW PORT SYSTEM. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/15/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DUE TO A CLERICAL ERROR, THE STATUTORY MDR FILING DATE WAS MISSED.
THE DEVICE WAS APPLIED DURING A FEMORAL POPLITEAL PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE HOSP HAS REPORTED NO PT INJURY OCCURRED. EXPIRATION DATE: 11/30/2000.
10/15/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DUE TO CLERICAL ERROR, THE STATUTORY MDR FILING DATE WAS MISSED.
THE PT HAD JUST COMPLETED A PROSTATRON TREATMENT PROCEDURE. (PROSTATRON TRETMENT USES A FOLEY CATHETERLIKE TREATMENT CATHETER CALLED THE PROBE WHICH HAS A BLADDER RETENTION BALLOON. AT THE END OF THE CASE, THE RPTR HAD DIFFICULTY DEFLATING THE CATHETER'S BLADDER BALLOON, AND NO FLUID WAS OBTAINED WHEN DRAWING BACK ON THE BALLOON LUMEN WITH A SYRINGE. USING ABDOMINAL ULTRASOUND, IT WAS CONFIRMED THAT THE BALLOON WAS STILL INFLATED. A SUPRAPUBIC STICK WITH A SPINAL NEEDLE WAS USED UNDER ULTRASOUND GUIDANCE TO SUCCESSFULLY DEFLATE THE BALLOON, PERMITTING CATHETER WITHDRAWAL. RPTR INDICATED THERE WERE NO SEQUELAE TO THE PT. THE CASE WAS PROLONGED APPROX 10 MINS DUE TO THE EVENT.
THIS IS THE FIRST REPORT OF BALLOON DEFLATION DIFFICULTY WITH A CATHETER, ALTHOUGH THIS TYPE OF PROBLEM HAS BEEN COMMONLY REPORTED IN THE MEDICAL LITERATURE FOR OTHER UROLOGICAL BALLOON CATHETERS, SUCH AS FOLEY CATHETERS. CO'S EVALUATION INDICATES THAT THE TUBING USED TO INFLATE AND DEFLATE THE BALLOON WAS KINKED, MAKING IT DIFFICULT TO DEFLATE THE BALLOON AT THE END OF THE PROCEDURE. CO IS CONSIDERING THE ADDITION OF A MINOR LABELING STATEMENT TO ADVISE THE USER OF A SIMPLER METHOD (CUTTING THE CATHETER INFLATION LINE) FOR DEFLATING THE BALLOON SHOULD DIFFICULTY BE OBSERVED. THIS METHOD WOULD HAVE AVOIDED THE NEED FOR THE USER'S DECISION TO PERFORM A SUPRAPUBIC PUNCTURE.
DURING A HEPATIC LOBECTOMY PROCEDURE, THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEUDRE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/15/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DUE TO A CLINICAL ERROR, THE STATUTORY MDR FILING DATE WAS MISSED.
HEALTHCARE PROFESSIONAL STATED THE VALVE WAS REMOVED DUE TO REGURGITATION AND STENOSIS. CUSPAL STRETCHING AND NON-COAPTATION OF A FREE MARGIN WAS NOTED. VALVE WAS IMPLANTED 1 MONTH.
NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY THEREFORE, INFORMATION ON THIS MEDWATCH FORM 3500 A WAS COMPLETED BY MEDTRONIC WITH INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500 A ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFORMATION FROM THE REPORTER, MEDTRONIC IS UNABLE TO COMPLETE FORM 3500 A." H3 ANALYSIS: THE LEAFLETS WERE FLEXIBLE AND INTACT. THE FREE MARGIN OF THE RIGHT CUSP IS ON THE SAME PLANE AS THE INLFOW POINT OF COAPTATION OF THE NON-CORONARY CUSP. NATURAL FENESTRATION BELOW LEFT CUSP FREE MARGIN. RADIOGRAPHS SHOW NO MINERALIZATION. HYDRODYNAMIC TEST DATA SHOWED AN AVERAGE NEGATIVE FLOW OF 2.3 ML PER BEAT; <8 ML PER BEAT IS CONSIDERED NEGLIGIBLE. STERILIZATION OF THE EXPLANTED VALVE AND A THICKENED NON-CORONARY CUSP MAY HAVE CONTRIBUTED TO A HIGHER GRADIENT THAN THE CLINICAL COMPARISON. FUNCTIONAL TESTING WAS ACCEPTABLE. CAUSE OF THE REPORTED REGURGITATION COULD NOT BE DETERMINED.
THE DEVICE WAS APPLIED DURING AN OOPHERECTOMY PROCEDURE. REPORTEDLY, A BURN WAS NOTICED WHEN THE TROCAR WAS REMOVED. THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME INSTRUMENT. EXPIRATION DATE: 6/30/2001.
THE DEVICE WAS APPLIED DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE. REPORTEDLY, A BURN WAS NOTICED ON THE PT UPON REMOVAL OF THE TROCAR. THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME INSTRUMENT. EXPIRATION DATE: 7/31/2001.
DURING AN UNSPECIFIED PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
PT'S DAUGHTER REPORTED THAT HER FATHER OBTAINED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH STRIPS, LOT 1K501A. SHE STATED THAT, AS A RESULT OF THE INACCURATELY LOW READINGS, THE PT EXPERIENCED HYPERGLYCEMIA, WAS TRANSFERED TO HOSP. CONTACT DOES NOT KNOW WHEN HER FATHER OPENED TEST STRIPS. HE OBTAINED BLOOD GLUCOSE READINGS IN THE 35 MG/DL RANGE FOR AN UNK AMOUNT OF TIME. THE DESICCANT IS IN THE BOTTLE. PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. PT STORES TEST STRIPS IN BEDROOM AND DOES NOT EXPOSE THEM TO EXTREME HEAT, COLD OR MOISTURE AS DIRECTED IN PACKAGE INSERT. HE DOES NOT KEEP TEST STRIP BOTTLE OPEN FOR A PROLONGED PERIOD OF TIME. CONTACT DID NOT HAVE NORMAL CONTROL SOLUTION AVAILABLE TO CHECK TEST STRIPS FOR ACCURACY. WITH THE REP, SHE OBTAINED BACK TO BACK CHECK STRIPS RESULTS OF 90 AND 89 VERSUS A CHECK STRIP RANGE OF 75-99. THE REP WILL SPEAK WITH CONTACT TOMORROW TO OBTAIN MORE SPECIFIC INFO. CONTACT WAS UNABLE TO GIVE SPECIFIC INFO TO THE REP TODAY BECAUSE SHE HAD TO LEAVE FOR AN APPOINTMENT. ON 8/26/96, FOLLOW-UP INFO WAS OBTAINED BY THE CUSTOMER SUPPORT REP: CONTACT REPORTED THAT THE PT, A 74 YR. OLD TYPE II DIABETIC WHO ADMINISTERS INSULIN DAILY, OBTAINED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH STRIPS. PT OPENED BOTTLE OF TEST STRIPS APPROXIMATELY ONE MONTH AGO. HE COULD NOT REMEMBER WHAT HIS TYPICAL BLOOD GLUCOSE READINGS WERE AT THE TIME. ON APPROXIMATELY 8/12/96, PT BEGAN TO EXPERIENCE HYPERGLYCEMIC SYMPTOMS (NAUSEA, DIZZINESS, FREQUENT URINATION). CONTACT MISTOOK THESE SYMPTOMS FOR HYPOGLYCEMIA AND, FOR THIS REASON, SHE TOOK THE PT'S BLOOD GLUCOSE AT 2:00AM ON 8/13/96 WHEN HE WOKE HER AND STATED HE WAS NOT FEELING WELL. PT'S BLOOD GLUCOSE RESULT WAS 35MG/DL SO SHE GAVE HIM ORANGE JUICE TO DRINK. AT 4:00AM, CONTACT TOOK PT'S BLOOD GLUCOSE AND , AGAIN, OBTAINED A BLOOD GLUCOSE RESULT IN THE 30MG/DL RANGE. SHE DID NOT KNOW THE SPECIFIC RESULT. BECAUSE SHE QUESTIONED THIS READING, CONTACT IMMEDIATELY TOOK PT'S (CONTACT IS ALSO A DIABETIC). SHE OBTAINED A BLOOD GLUCOSE RESULT IN THE 300 MG/DL RANGE. SHE COULD NOT REMEMBER THE SPECIFIC RESULT. BECAUSE THE PT'S BLOOD GLUCOSE WAS ELEVATED, CONTACT GAVE PT 10 UNITS OF 70/30 INSULIN AND CALLED 911. BECAUSE THE PT LIVES IN A RURAL AREA, THE PARAMETICS ARRIVED BY HELICOPTER 1 AND 1/2 HOURS LATER. AT THIS TIME, THE PT'S BLOOD GLUCOSE WAS 189 MG/DL (TEST PERFORMED BY A PARAMETIC WITH PT'S METER AND THE CONTACT'S DIFFERENT BRAND TEST STRIPS.) PT WAS HAVING CHEST PAINS UNRELATED TO THE HYPERGLYCEMIA AND WAS TRANSPORTED TO THE HOSP VIA HELICOPTER. CONTACT STATED THAT THE PARAMEDICS ADMINISTERED AN I.V. BUT SHE DID NOT KNOW THE SPECIFIC MEDICATION. PT WAS ADMITTED TO THE HOSP FOR TWO DAYS FOR FURTHER EVAL OF THE CHEST PAINS AND TO MONITOR HIS BLOOD GLUCOSE. PT'S BLOOD GLUCOSE IS NOW IN TH E120 MG/DL RANGE WITH DIFFERENT BRAND TEST STRIPS. NEITHER THE PT NOR THE CONTACT HAVE NORMAL CONTROL SOLUTION AVAILABLE TO CHECK THE TEST STRIPS FOR ACCURACY.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 9/3/96. ONE OPENED BOTTLE, CONTAINING 17 STRIPS WITH DESICCANT WAS RETURNED TO CO FOR EVAL. THE TEST RESULTS OF THE RETURNED BOTTLE MET THE SPEC FOR BLOOD GLUCOSE ACCURACY AND DID NOT CONFIRM THE COMPLAINT OF LOW BLOOD GLUCOSE READINGS. ALL TEST RESULTS ARE WITHIN ZONE A IN ERROR GRID ANALYSIS. ALL RETENTION SAMPLE TEST RESULTS FOR LOT 1K501A MEET THE SPECS FOR THE BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. TREND ANALYSIS OF COMPLAINTS SHOWS THIS IS THE FIRST COMPLAINT OF LOW BLOOD GLUCOSE READINGS FOR LOT 1K105A. BASED ON THE PRESENT EVAL, CO IS UNABLE TO CONFIRM THE COMPLAINT OF LOW BLOOD GLUCOSE READINGS. THEREFORE, THE PROBABILITY THAT THIS WAS A PRODUCT MALFUNCTION IS LOW AND THAT IT IS UNLIKELY TO RECUR. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N.  SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
A J-TUBE WAS INSERTED BY THE HOSP PRIOR TO DISCHARGE TO THE HOME. A FEMALE JUNCTION INSIDE OF THE J-TUBE DISCONNECTED FROM THE FEEDING TUBE AND A PIECE OF PLASTIC INSIDE OF THE J-TUBE, WHICH HOLDS THE FEEDING TUBE, BROKE LOOSE AND COULD NOT BE FOUND. THE J-TUBE HAD TO BE MEDICALLY REPAIRED OR REPLACED TO AVOID COMPLICATIONS.
H6: METHOD-DEVICE NOT RETURNED TO ASSIST IN EVALUATION.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE STAPLE LINE WAS INCOMPLETE. THE SURGEON COMPLETED THE PROCEDURE BY MANUAL SUTURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
1/27/97-IT HAS COME TO CO'S ATTENTION THAT TWO EVENTS WERE INADVERTENTLY SUBMITTED UNDER THE SAME MFR REPORT NUMBER, 1219161-1996-147. THE FIRST SUBMISSION WAS SENT ON 10/2/96 AND SHOULD BE DISREGARDED. THE SECOND SUBMISSION WAS SENT ON 10/15/96 AND IS CORRECT. ALL FUTURE SUBMISSIONS UNDER MFR REPORT NUMBER 1219161-1996-147 WILL REFER TO THE EVENT DESCRIBED IN THE SUBMISSION OF 10/15/96.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED ON PT INJURY OCCURRED.
A FACILITY REPORTED THAT A PT HAD LOST APPROX 3 KG MORE THAN THE MACHINE HAD RECORDED. THE MACHINE'S PRETREATMENT TESTING HAD PASSED PRIOR TO INITIATION OF THE TREATMENT. AFTER 1 HOUR INTO THE TREATMENT, THE PT BEGAN CRYING, SPITTING AND COMPLAINED OF NAUSEA. THE PT WAS HYPOTENSIVE AND RESPONDED TO 100 ML OF NORMAL SALINE. A FEW MINUTES LATER WATER WAS NOTED ON THE FLOOR UNDER THE MACHINE. THE PT WAS NOW COMPLAINING OF CRAMPING. THE TREATMENT WAS DISCONTINUED. THE FACILITY DID NOT KNOW IF THE RECOMMENDED TMP ALARM LIMITS WERE SET FOR HIGH FLUX DIALYSIS. THE FACILITY REPORTS THAT NO USUSAL ALARMS OCCURRED. THE FACILITY MACHINE TECHNICIAN INSPECTED THE MACHINE AND FOUND A LEAKING TRANSDUCER. HE REPLACED THE TRANSDUCER AND VERIFIED PROPER MACHINE OPERATION. THE FACILITY STATED THE MACHINE HAS BEEN OPERATING PROPERLY SINCE REPAIR.
PART WAS RECEIVED IN RETURNED GOODS BUT WAS NOT RECEIVED BY FAILURE ANALYSIS. PART COULD NOT BE LOCATED.
A FACILITY MACHINE TECHNICIAN FOUND THAT DURING A MACHINE PREVENTIVE MAINTENANCE THE LINE CLAMP WAS NOT OPERATING PROPERLY. HE CLEANED THE BUMPER PIECE AND VERIFIED PROPER OPERATION. FURTHER FOLLOW UP WILL BE MADE WITH THE MFR OF THIS COMPONENT. IF THIS COMPONENT SHOULD MALFUNCTION, PT INJURY IS NOT LIKELY UNLESS THE OPERATOR OVERRIDES THE ALARM CONDITION.
THIS MODULE WAS MADE BY ANOTHER MFR. FOLLOW UP WITH THE MFR IS IN PROGRESS.
AN INFANT RESUSCITATION SUPPORT DEVICE WAS TAKEN OUT OF ITS PLASTIC CONTAINER AND MADE READY FOR USE ON AN ADULT PT. WHEN USED IT CAUSED MAJOR COMPLICATIONS. THE PT HAD TO BE TREATED FOR A TENSION PNEUMOTHORAX. IT WAS FOUND THAT THE BAG PORTION OF THE DEVICE WAS INSERTED INTO THE TUBING BACKWARDS (VALVE END). IT IS NOT KNOWN IF A STAFF MEMBER PUT THE DEVICE TOGETHER INCORRECTLY OR IF IT WAS TAKEN OUT OF THE BAG THAT WAY. ALL REMAINING DEVICES ARE PUT TOGETHER CORRECTLY.
HIGH PRESSURE ALARM DURING EARLY STAGE OF TREATMENT LED TO VISUAL INSPECTION OF ARTERIAL NEEDLE. BEVEL HEAL WAS VISIBLE IN THE PT'S ARM AND CANNULA WAS VISIBLE IN AVF TUBING. CANNULA HAD BEEN PUSHED BACK THROUGH HUB.
CO PERFORMED A VISUAL INSPECTION AND FUNCTIONAL TESTING ON CO'S IN HOUSE RETENTION SAMPLES FROM THIS LOT AND ALL PRODUCT WERE WITHIN SPECIFICTIONS. CO IS CURRENTLY INVESTIGATING THE RETURNED SAMPLE AND WILL FOLLOW-UP THIS REPORT IF THE RESULTS WARRANT ADD'L INFO.
THE PRODUCT WAS USED DURING A LAPAROSCOPIC TOUPE PROCEDURE. REPORTEDLY, THE NEEDLE DISENGAGED INTO THE PT'S CAVITY. THE NEEDLE WAS RETRIEVED WITHOUT INCIDENT.
10/17/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
PT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT LOCK. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE PNEUMOPERITONEUM LEAKED FROM THE DEVICE. THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME INSTRUMENT. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
ANESTHESIA MACHINE WAS USED TO GIVE GENERAL ANESTHESIA TO A SIX YEAR OLD CHILD. AT TIME OF INDUCTION THE VAPORIZER WAS TURNED ON FOR USE AND THERE WAS A HIGH CONCENTRATION OF HALOTHANE THE MOMENT THE VAPORIZER WAS OPENED. AS A RESULT, THE CHILD SUFFERED A CARDIOVASCULAR COLLAPSE DURING INDUCTION. FURTHER MORE THE CHILD SUFFERED SEVERE ANOXIC BRAIN INJURY AND WILL REQUIRE LONG TERM CUSTODIAL CARE. THE ENVIRONMENTAL CONDITIONS THAT MAY HAVE INFLUENCED THE EVENT WOULD BE THE WAY THAT THE AGENCY TRANSPORTED OR STRAPPED IN THE MACHINE ON THE AIRPLANE. A REPORT FROM THE MFR INDICATES THEY FOUND THAT THERE WAS A MASSIVE EXTERNAL LEAK OF HALOTHANE FROM THE VAPORIZER. THE VAPORIZER IS BEING FURTHER EVALUATED AT THIS TIME. THE FINAL RESULTS ARE NOT YET KNOWN.
THE DEVICE AS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE PNEUMOPERITONEUM LEAKED FROIM THE DEVICE. THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME INSTRUMENT. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
10/17/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. THE PRODUCT WAS NOT RETURNED FOR EVAL.
ON 9/20/96 IT WAS REPORTED TO CO THAT A MALFUNCTION OCCURRED TO A CO'S DEVICE. DURING A CARDIAC PROCEDURE THE SYSTEM MAIN CIRCUIT BREAKER TRIPPED. BREAKER WAS RESET, SYSTEM RECYCLED, AND PROCEDURE CONTINUED FOR A BRIEF TIME WHEN THE BREAKER TRIPPED AGAIN. THE HOSP REMOVED THE SYSTEM AND BROUGHT IN BACKUP EQUIPMENT TO FINISH PROCEDURE. FIELD SERVICE ENGINEER WAS UNABLE TO DUPLICATE THE MALFUNCTION. FSE DIAGNOSED THAT THE MAIN CIRCUIT BREAKER, SURGE SUPPRESSER PCB, AND POWER CONTROL PCB NEEDED TO BE REMOVED AND REPLACED. FSE TESTED/INSPECTED AND RETURNED SYSTEM TO CURRENT SPECIFICATIONS. HOSP REPORTED NO ADVERSE EVENT, DEATH, OR SERIOUS INJURY TO PT INVOLVED. ON 9/25/96 IT WAS REPORTED TO CO THAT THE PT INVOLVED IN THE PROCEDURE ABOVE HAD DIED. CO DISPATCHED FSE TO CHECK SYSTEM PERFORMANCE. FSE TESTED/INSPECTED AND FOUND SYSTEM TO BE OPERATING TO CURRENT SPECIFICATIONS. CO CONTACTED HOSP RISK MGMT, WHICH REPORTED PT DIED ON 9/21/96. CO OPENED A FORMAL FAILURE INVESTIGATION UNDER CORRECTIVE ACTION PROGRAM.
THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION, 21 CFR 803.24 AND 21 CFR 804. NEITHER THIS MDR REPORT NOR ANY INFO CONTAINED THEREIN SHALL REFLECT A CONCLUSION BY THE MFR OR FDA THAT THE REPORT OR INFO CONSTITUTES AND ADMISSION ON BEHALF OR OEC MEDICAL SYSTEMS, INC. THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT CAUSED OR CONTRIBUTED, DIRECTLY OR INDIRECTLY, TO A DEATH  OR A SERIOUS INJURY OR THAT IT WAS DEFECTIVE OR MALFUNCTIONED IN ANY WAY. OEC MEDICAL SYSTEMS, INC. DENIES THAT THIS REPORT OR THE INFO CONTAINED THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE WHICH IS THE SUBJECT OF THIS REPORT CAUSED OR CONTRIBUTED TO A DEATH, INJURY OR THAT IT WAS FEFECTIVE OR MALFUNCTIONED IN ANY WAY. H6 -CODE 400 OTHER -CIRCUIT BREAKER.
THE DEVICE WAS APPLIED DURING A HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT RELEASE STAPLES. THE SURGEON APPLIED MANUAL SUTURE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
10/18/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
WHILE IN THE PROCESS OF CONDUCTING AN INTERNAL RECALL OF THE DEVICE WITH CO REPS, A DEFECTIVE SET WITH A DIFFERENT LOT NUMBER WAS DISCOVERED. THE TUBING WITH THE DRIP CHAMBER VENT SLIDE CLAMP IS REVERSED WITH THE TUBING WITH THE BACKCHECK VALVE WITH UPPER Y-INJECTION SITE WHERE THEY ENTER THE DRIP CHAMBER.
IV TUBING WAS LEAKING AT THE "Y" SITE OF THE PRIMARY IV TUBING.
DEVICE WAS RETURNED FOR REPAIR WITH INNER TIP MISSING AND ACTUATOR ROD BROKEN.
DEVICE EVALUATION REVEALED DEVICE EDGES WERE DULL. INDICATING DEVICE WAS IN THE NEED OF SERVICING. NO PT INJURY OR SURGICAL DELAY WAS REPORTED. "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT."
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION PROCEDURE. THE SURGEON STATED THE STAPLE LINE WAS COMPLETE, HOWEVER, BLEEDING WAS OBSERVED. HE OVERSEWED THE APPLICATION SITE TO CORRECT THE CONDITION. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE FAILED THE LEAK TEST DURING PERFORMANCE OF AN INCOMING EVAL. THE SVC TECHNICIAN INSPECTED THE DEVICE AND ADJUSTED THE SAFETY DUMP SPRING. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE T CONNECTOR DISCONNECTED FROM THE IV LINE RESULTING IN THE LOSS OF BLOOD. PT WAS GIVEN LACTATED RINGERS AND BLOOD. ARTERIAL LINE HAD BEEN PLACED AND INFUSING WITH T-CONNECTOR WITH NO PROBLEM. HAND WAS TURNED TO RESECURE PIV ON TOP OF HAND. WHEN THE HAND WAS TURNED TO PLACE ARMBOARD THE T-CONNECTOR WAS OUT OF IV AND APPROX. 5CC OF BLOOD WAS LOST. THE T-CONNECTOR WAS REPLACED AND THE LINE FLUSHED. HEMATOCRIT PRIOR TO EVENT WAS 35.4. AFTER EVENT IT WAS 35.9. DUE TO POOR PERFUSION AND BP TWO 10 U/KG OF LACTATED RINGERS WERE GIVEN. ALSO 10 U/KG OF BLOOD WAS GIVEN DUE TO POOR COLOR AND PERFUSION.
END USER HOSP REPORTED RECEIVING TWO KITS IN UNSEALED POUCHES. THE KITS WERE NOT USED.
RETURNED POUCH WAS FOUND TO HAVE BEEN SEALED, BUT WITH A LESS THAN ADEQUATE SEAL. PACKAGES ARE ROUTINELY SEAL CHECKED AS PART OF THE PACKAGING PROCESS. CO HAS DETERMINED THIS TO BE AN ISOLATED INCIDENT AND AN EMPLOYEE ERROR. THE PACKAGING ASSOCIATE RESPONSIBLE FOR PROVIDING SEAL CHECKS ON THIS LOT HAS BEEN RE-TRAINED. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFORMATION CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF NAMIC USA CORP. THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
DEVICE WAS RETURNED FOR REPAIR WITH BROKEN TIP.
DEVICE WAS RETURNED FOR REPAIR. HOSP STATED NO PT INJURY OR SURGICAL DELAY OCCURRED. HOSP CONTACT IS UNSURE OF HOW DEVICE WAS BROKEN. "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT."
AFTER SEVERAL DAYS OF WEARING STOCKINGS, NOTED ABRASION TO RIGHT UPPER ANKLE AND CREASES IN LEFT ANKLE. STOCKINGS "TRAVEL" CONSTANTLY. THEY DO NOT STAY IN PLACE. HARD/SHARP EDGE TO PLASTIC AIR BLADDER RUBS UPPER ANKLE.
AFTER MOUNTING HEAVY COLLIMATORS,WHILE ROTATING CAMERA TO HOME POSITION, ONE COLLIMATOR FELL FROM HEAD #1 TO THE FLOOR. DAMAGE TO EQUIPMENT ONLY.
CO FIELD ENGINEER AND NUCLEAR MEDICINE SPECIALIST WENT TO SITE THE SAME DAY AS THE EVENT. THEY ASCERTAINED THAT THE COLLIMATOR HAD NOT BEEN PROPERLY MOUNTED, PERMITTING THE COLLIMATOR IN HEAD #1 TO FALL. TESTS WERE RUN, ATTEMPTING IMPROPER MOUNTING WITH OTHER COLLIMATORS; HOWEVER, IT WAS NOT POSSIBLE TO DO SO. THE CAMERA WAS TESTED. THE SYSTEM WAS OPERABLE WITH ALL OTHER COLLIMATORS. ON 10/21/96 FIELD ENGINEERS WERE DIRECTED TO CONTACT EACH USER OF THE CO'S GAMMA CAMERA WITH NOTIFICATION OF A NEW SAFETY PROCEDURE. ON 10/24/96 CERTIFIED LETTERS WILL GO TO EACH USER WITH A SHEET OF STICKERS TO BE ATTACHED TO EACH COLLIMATOR CART READING: "PATIENT SAFETY WARNING - CHECK COLLIMATOR ALIGNMENT VISUALLY AFTER INSERTION TO ENSURE PROPER MOUNTING: GUIDING PINS MUST BE INSIDE BOTH UPPER AND LOWER RECEIVING SLOTS; TEST 360 DEGREES ROTATION AFTER EACH COLLIMATOR CHANGE BEFORE PUTTING THE PT IN THE CAMERA." DESIGN ENGINEERS FROM THE MFR WENT TO HOSP TO INSPECT THE UNIT ON 10/21/96. TO PREVENT ANY POSSIBLE RECURRENCE OF THIS INCIDENT, 2 BRACKETS WERE AFFIXED TO THE TOP COLLIMATOR RAILS OF EACH COLLIMATOR CART TO ENSURE THE PROPER ALLIGNMENT OF THE CART RAILS AND THE CAMERA HEAD RAILS DURING COLLIMATOR CHANGES.
THERE WAS NO AUDIO ALARM. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND FOUND THE AUDIO ALARM KIT HARNESS WAS NOT CONNECTED TO THE FRONT PANEL BOARD. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE DEVICE MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
STOCKINGS WERE REMOVED AFTER NOTING 2 INDENTATIONS ON PT'S ANKLES. ALSO NOTED SEVERE INDENTATIONS BELOW KNEES. STOCKINGS WERE ON PROPERLY.
THE T-CONNECTOR DISCONNECTED FROM THE IV LINE RESULTING IN THE LOSS OF BLOOD. PT WAS GIVEN LACTATED RINGERS AND BLOOD.
CUSTOMER INDICATED SAMPLES WOULD NOT BE RETURNED TO CO FOR EVALUATION. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OR RETURNED PRRODUCT EVALUATION. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
DEVICE TIP WAS REPORTED BROKEN AT WELD IN SURGERY.
ENTIRE DEVICE WAS NOT RETURNED FOR EVALUATION. HOSP CONTACT REPORTED TIP WAS RETRIEVED RESULTING IN A SHORT SURGICAL DELAY. NO PT INJURY WAS REPORTED. "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SNITH & NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBURTED TO THE EVENT DESCRIBED IN THIS REPORT."
WHILE DR WAS USING INSTRUMENT A SMALL PIECE CAME OUT OF THE 30 DEGREE TIP.
DURING A ROUTINE PHACOEMULSIFICATION PROCEDURE, THE DR OBSERVED PARTICLES ENTERING THE EYE FROM THE NEEDLE. ALL OF THE PARTICLES WERE REMOVED AND THERE WAS NO PT HARM.
ALL THE INFO IN BLOCK F WAS COMPLETED BY THE MFR. H6 CODE#86-EXFOLIATION TESTS WERE CONDUCTED ON THE PRODUCT. THE NEEDLE WAS EVALUATED FOR PARTICULATE EXFOLIATION AND THE PRODUCT WAS FOUND TO BE WITHIN THE SPECIFICATION. EXAM OF THE NEEDLE SHOWED EVIDENCE OF HUB DAMAGE POSSIBLY CAUSED DURING INSTALLATION OR REMOVAL OF THE NEEDLE. THE REMAINING NEEDLE APPEARED IN GOOD CONDITION.
WHILE PERFORMING A FIELD ACTION, THE AUDIO ALARM WAS FOUND COVERED WITH AN ADHESIVE TAPE. THE CUSTOMER SUPPORT ENGINEER REMOVED THE TAPE AND VERIFIED THE FUNCTION OF THE ALARM. THE CSE REPORTED THE FINDINGS TO THE CUSTOMER. THE UNIT PASSED EXTENDED SELF TESTING. NO PARTS WERE REPLACED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
ADD'L NARRATIVE: IS BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
NEW PIV INSERTED. DISCOVERED T-CONNECTOR DISCONNECTED WHEN ATTEMPTING TO GIVE BLOOD. ESTIMATED BLOOD LOSS AT 24 CC. ADD'L BLOOD WAS GIVEN.
NURSE NOTICED CLICKING SOUND FROM VENT. RT PRESENT. LOW ALARM KEPT SOUNDING CONTINUOUSLY. ALL CIRCUITRY WAS CHECKED OUT COMPLETELY AND THERE WERE NO LEAKS IN THE SYSTEM. VENT WAS EXCHANGED. APPEARS THAT PRESSURE LIMIT VALVE WAS STICKING AND PT WAS NOT RECEIVING FULL BREATH FROM VENT.
THE T-CONNECTOR DISCONNECTED FROM THE IV LINE WHILE ATTEMPTING TO GIVE BLOOD RESULTING IN THE LOSS OF BLOOD. PT WAS GIVEN ADD'L BLOOD.
CUSTOMER INDICATED SAMPLES WOULD NOT BE RETURNED TO CO FOR EVALUATION. LOT HISTORY REVIEW WAS NOT AVAILABLE AS THE LOT NUMBER WAS UNKNOWN TO THE CUSTOMER. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVALUATION. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
10/18/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. RECEIVED PACKAGING ON 9/30/96, CLINICAL DEVICE WAS NOT RETURNED FOR EVAL.
THERE WAS A NO AUDIO ALARM CONDITION. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF TESTING. NO PARTS WERE REPLACED. IT IS NOT VERIFIED THAT THE ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TOT HE EVENT ALLEGED IN THIS REPORT.
PT USES VENTILATOR 16 HRS PER DAY WITH PRESSURE LIMIT. VALVE STARTED STICKING CAUSING LOUD POPPING NOISE. HIGH PRESSURE AND LOW PRESSURE ALARM ALSO WENT OFF. PT MISSED SEVERAL BREATHS.
THE DEVICE WAS APPLIED DURING A LOBECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
12/13/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
THE DEVICE WAS USED DURING A CESEREAN SECTION PROCEDURE. THE STAPLES FROM THE DEVICE FROM THE STAPLER CAME OUT OF THE JAWS CROOKED AND HUNG UP ON ONE SIDE. IT WAS UNKNOWN IF THE STAPLES WERE HANGING UP IN TISSUE OR JAW OF THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVAL: CONCLUSION: BASED ON THE INQUIRY INFO AND THE VISUAL EXAMINATION IT WAS CONCLUDED THAT THE REPORTED INCIDENT MAY HAVE BEEN DUE TO A DEFECTIVE COMPONENT. COMMENTS-CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE HEPARIN 25,000 UNITS/250ML AT 3 ML/HR ON LINE D. LINE A WAS AN UNSPECIFIED HYDRATION FLUID AT AN UNSPECIFIED RATE, AND LINES B AND C WERE INTERMITTENT ANTIBIOTICS AND THE ALBUMIN INFUSION. ALL BUT LINE D INFUSED APPROPIATELY AS PROGRAMMED. THE HEPARIN INFUSION WAS STARTED AT 2PM. APPROX. 7 HRS LATER, AT 9:20PM, THE NURSE NOTED THAT THE HEPARIN CONTAINER WAS EMPTY. THE PROGRAM WAS CHECKED, AND NOTED TO BE CORRECT AT 3 ML/HR WITH A TOTAL DELIVERED AMOUNT OF 21.2 ML DISPLAYED. THE PT WAS STATUS POST FEMORAL-POPLITEAL-TIBIAL ARTERIAL BYPASS AND THE NURSE OBSERVED BLEEDING AT THE OPERATIVE SITE. THE PT'S PTT WAS ELEVATED AND HER HEMOGLOBIN DROPPED BY APPROX. 2.5 GM. SHE RECEIVED 200MG OF PROTAMINE, 3 UNITS OF PACKED RED BLOOD CELLS AND 1 UNIT OF FRESH FROZEN PLASMA. SHE WAS RETURNED TO THE OPERATING ROOM FOR EVACUATION OF CLOTS DUE TO SWELLING, HEMATOMA, AND DIMINSHED PULSES IN THE EFFECTED EXTREMITY. SHE LATER IMPROVED AND WAS TRANSFERRED FROM ICU TO A GENERAL NURSING FLOOR. ON 9/23/96 SHE EXPERIENCED RESPIRATORY DISTRESS AND RENAL INSUFFICIENCY AND WAS RETURNED TO THE ICU. SHE REQUIRED INTUBATION AND VENTILATION AND A PULMONARY ARTERY CATHETER WAS PLACED. SHE IMPROVED AND REMAINED ALERT, BUT PER FAMILY AND PT REQUEST, SHE WAS TRANSFERRED TO A TERTIARY CARE HOSP. CIRCULATION HAD RESOLVED. NO FURTHER INFO IS AVAILABLE.
THE PUMP AND IV CASSETTE ARE PRESENTLY ISOLATED WITH HOSP RISK MGMT. THEY ARE REQUESTING THIRD PARTY INDEPENDENT TESTING OF THE DEVICES.
PT HAD PICC LINE INSERTED ON 10/3/96. ON EVENING OF 10/8, PT TRIED TO GIVE 2200 DOSE OF ANTIBIOTIC BUT ONLY RECEIVED HALF. ATTEMPTED TO FLUSH LINE BUT IT WAS DIFFICULT. SOMETHING THEN GAVE WAY. THE PT WAS ABLE TO FLUSH CATHETER. THE CATHETER WAS LEAKING JUST BELOW THE HUB. THE CATHETER CONTINUED TO LEAK AFTER FLUSHING. PT CALLED RN IN AM AND REPORTED IT. RN NOTED LEAKAGE BELOW FIRST WHITE "T" CONNECTOR. PT'S VEIN VISIBLE AS DARK PURPLE 2.5 CM BEYOND END OF PICC. PICC LINE REMOVED W/O INCIDENT. PT SEEN IN ER ON 10/9 AT 11:50 AM. CHEST X-RAY NORMAL, WBC - 9.7. PLATELET COUNT SLIGHTLY ELEVATED. ARM WARM TO TOUCH AND SLIGHTLY INFLAMED. PULSE WAS GOOD AND REFLEXES EQUAL.
THE CUSTOMER REPORTED VIA MEDWATCH THE VENTILATOR STOPPED OPERATING AND ALARMED. THE PT WAS REPORTEDLY MANUALLY VENTILATED UNTIL THE VENTILATOR WAS REPLACED BUT SUFFERRED NO ADVERSE EFFECTS FROM THE INCIDENT. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND WAS UNABLE TO DUPLICATE THE CONDITION BUT DID FIND AN ERROR CODE IN MEMORY INDICATING THE UNIT HAD ENTERED BACK UP VENTILATION MODE. THE CSE REPLACED THE CONVERSION BOARD AS A PRECAUTION AND VERIFIED THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT EJECTED CLIPS PREMATURELY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
UNSUCCESSFUL ATTEMPT TO PLACE STENT. ON PULL BACK OF SHEATH AND BALLOON, NOTED STENT HAD BEEN DETACHED. UNABLE TO LOCATE UNDEPLOYED STENT. NEW STENT DEPLOYED SUCCESSFULLY. PT DISCHARGED IN STABLE CONDITION.
THE DEVICE WAS USED DURING A THIGH LACERATION REPAIR. THE STAPLES FROM THE STAPLER CAME OUT OF THE JAWS CROOKED AND HUNG UP ON ONE SIDE. IT WAS UNKNOWN IF THE STAPLES WERE HANGING UP IN TISSUE OR JAWS OF THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: INSTRUMENT WAS REC'D WITH THE WELD BROKEN AT THE NOSE OF THE CARTRIDGE.
THE INFO WAS INITIALLY RECEIVED FROM THE USER FACILITY ON A MEDWATCH FORM AND IS REPLICATED IN SECTIONS A-F. THIS INFO WAS CONFIRMED IN A TELEPHONE CONVERSATION WITH THE RISK MGMT COORDINATOR.
THE LENS HAPTIC BROKE DURING INSERTION AND WHEN THE LENS WAS ROTATED, THE CAPSULES TORE. A VITRECTOMY WAS PERFORMED AND AN ANTERIOR CHAMBER LENS WAS INSERTED.
A2: ACCOUNT UNABLE TO PROVIDE INFO. A3: ACCOUNT UNABLE TO PROVIDE INFO. A4: ACCOUNT UNABLE TO PROVIDE INFO. 2200=VITRECTOMY, LABELED. H6: RESULTS: 100=BROKEN HAPTIC. EVALUATION RESULTS: THE LENS WAS RETURNED WITH EVIDENCE OF SURGICAL RESIDUE. ONE OF THE HAPTICS IS BROKEN AT THE HAPTIC/OPTIC JUNCTION. THE DIMENSIONAL MEASUREMENTS OF THE HAPTIC AT THE BREAKAGE LOCATIONS MEET DESIGN SPECIFICATIONS. THE ANTERIOR AND POSTERIOR SURFACES OF THE OPTIC ARE SCRATCHED.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCCURED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED LAPAROSCOPIC PROCEDURE. REPORTEDLY, THE SAFETY SHIELD DID NOT RETRACT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
LENS REPLACEMENT DUE TO ACUTE CORNEAL DECOMPENSATION, CORNEAL TOUCH AND INFLAMMATION. A VITRECTOMY, LENS SUTURING AND A CORNEAL TRANSPLANT WERE PERFORMED. THE PHYSICIAN FELT THIS TO BE PRODUCT RELATED. THE PT'S PROGNOSIS IS GOOD.
A4: ACCOUNT UNABLE TO PROVIDE INFO. H6: METHOD-CODE 86=PRODUCT NOT RETURNED FOR AN EVALUATION.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HYSTERECTOMY. THE STAPLER HEAD BROKE ON THE THIRD FIRING. THERE WAS NO CONSEQUENCE TO THE PT. 09/24/96-REP RESPONDED ALL PIECES WERE RETRIEVED LAPAROSCOPICALLY.
D5,H4: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. CARTRIDGE B WAS RETURNED WITH THE MIDDLE ALIGNMENT FINGER BROKEN OFF AND WAS MISSING THE LOCKOUT TAB. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
THE END USER REPORTED SEVERAL INCIDENCES OF LEAKING FROM THE ROTATING ADAPTOR PORTION OF THE MANIFOLD PACKAGED IN THEIR CUSTOM KIT. THEY NOTED THAT THEY COULD DRAW BACK AIR WHEN A CATHETER WAS CONNECTED TO THE MANIFOLD. THERE WERE NO PT INCIDENCES.
EXAMINATION OF THE DEVICE REVEALED THAT AN OFFSET-RING IN THE ROTATING ADAPTOR WAS RESPONSIBLE FOR THE CONDITION THE END USER EXPERIENCED. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSON ON BEHALF OF CO, THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
PT ON NIPRIDE DRIP VIA CO'S IV PUMP (DUAL). PT BEING TRANSFERRED TO HOSP PER AMBULANCE (AMR SERVICE). A FEW MINUTES INTO THE RUN, BATTERY OPTION ON IV PUMP FAILED. STAFF STATED IV PUMP HAD BEEN PLUGGED IN WHILE PT WAS IN ACCU. PUMP # BACK-TACKED AND VERIFIED WITH CENTRAL PROCESSING DEPT. BIO-MEDICAL DEPT NOTIFIED TO CHECK PUMP. BIO-MEDICAL REPORT OF IV PUMP TESTING: DUAL PUMPS AT 50 ML/HR, 7:40 START, 8:10 LOW BATTERY MESSAGE; -AUDIBLE TONE, -ALERT LIGHT ON, 8:27 BOTH PUMPS STOPPED. CO CHANGED BATTERY ON 10/5/95. BATTERY CHECKS 6% ON ANALYZER. THIS UNIT WAS CHARGE OVERNIGHT (APPROX 17 HOURS). BOTH SIDES (PUMPS) WERE STARTED AT 7:40 AM AT 50 ML/HR RATE. AT 8:10 AM, LOW BATTERY MESSAGE ON ALONG WITH AUDIBLE TONE ALERT AND VISIBLE ALERT. AT 8:27 AM, BOTH PUMPS STOPPED PUMPING. BATTERY TESTED INDEPENDENTLY AND FAILED CAPACITY TEST.
HANDS WERE EXPOSED TO PRODUCT AND WHERE CUTS WERE, THE HANDS BECAME IRRITATED. ADVISED CALLER TO SEE A DR.
LABELING STATES "DO NOT GET PRODUCT ON SKIN OR ALLOW SKIN CONTACT".
ON SUCCESSIVE DAYS IN THE SAME PT, PICC CATHETER WAS INTRODUCED WITHOUT DIFFICULTY, NO KINK OR BEND PER INSTRUCTIONS, AND PROTOCOL, BUT USER WAS UNABLE TO RETRACT THE GUIDE WIRE. EFFORTS TO MANIPULATE THE GUIDE WIRE RESULTED IN GUIDE WIRE SLICING THROUGH THE CATHETER. AFTER CATHETERS WERE PULLED THE USER WAS UNABLE TO RETRACT THE WIRE ON CATHETER BUT WAS ABLE TO ON A SECOND. THE PT REQUIRED 3 STICKS TO PLACE THE CATHETER.
THE DEVICE WAS APPLIED DURING A THORACOSCOPIC LUNG REDUCTION. REPORTEDLY, THE INSTRUMENT MISFIRED. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC COLECTOMY. THE SURGEON TRIED TO TRANSECT AN ARTERY. THE INSTRUMENT CLAMPED DOWN AND THE BLACK HANDLE WOULD NOT CLOSE. THE KNIFE BLADE DID NOT ADVANCE. THE SURGEON RELOADED THE DEVICE AND IT STILL WOULD NOT FIRE. THERE WAS NO CONSEQUENCE TO THE PT.
H6;CODE 400: LEFT OUTER WEDGE SHIFTED TO LEFT INNER WEDGE SLOT. CONCLUSION: BASED UPON INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT WAS RETURNED NON-FUNCTIONAL. INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANSIM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: SOME CONDITONS WHICH MIGHT RESULT IN DAMAGE TO FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE THE ABDOMEN. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE PT WAS STARTED ON HEPARIN AT HOME FOR A DVT. THE PUMP DID NOT INFUSE PROPERLY. THE RES VOL WAS NOT DECREASING. THE USER COULD NOT GET THE PUMP TO RUN AFTER CHECKING THE BATTERIES AND TRYING TO ADJUST THE PUMP MANY DIFFERENT WAYS. THE PT DID NOT RECEIVE APPROX 3 HRS OF INFSUION. THE PT WAS CHANGED TO A DIFFERENT PUMP.
EIGHT IMPLANTS PLACED ON 11/30/95. 1 DID NOT INTEGRATE AND WAS REMOVED.
THE PT'S SMOKING IS THE LIKELY CAUSE OF FAILURE.
THE INJECTION CAP REMAINED IN THE OPEN POSITION AFTER THE PT WAS DISCONNECTED FROM THE IV INFUSION. NO ADVERSE REACTION RESULTED, BUT THE POTENTIAL FOR LINE INFECTION EXISTED.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTRECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT LOCK PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE CUSTOMER REPORTED VIA MEDWATCH THAT THEY FOUND THE VENTILATOR ALARMING AND IN A STATE OF APNEA. THE RESPIRATORY CARE PROFESSIONAL (RCP) ATTEMPTED TO DELIVER A MANUAL BREATH AND PLACE THE UNIT INTO CMV AND CPAP MODES OF VENTILATION WITHOUT SUCCESS. THE RCP THEN ATTEMPTED TO PLACE THE VENTILATOR INTO SIMV VENTILATION BUT THE UNIT WOULD NOT RESPOND TO THAT PROMPT EITHER. THE THERAPIST WAS ABLE TO PLACE THE VENTILATOR INTO CMV MODE AND THE VENTILATOR CYCLED. THE VENTILATOR WAS LATER REPLACED WITH THE PT SUFFERING NO EFFECTS. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE UNIT AND FOUND IT TO MEET SPECS. THE CSE DETERMINED THAT THE RESPONDING THERAPIST HAD NOT PRESSED ALARM RESET TO CLEAR THE APNEA ALARM PRIOR TO CORRECTING THE PT PROBLEM. THE CAUSE HAS BEEN DETERMINED TO BE USER ERROR AND THE CUSTOMER HAS BEEN ADVISED TO PROVIDE TRAINING TO THE THERAPIST. THIS REPORT IS NOT AN ADMISSION  BY CO THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
IMPLANT BECAME INFECTED AND WAS REMOVED. IT WAS PLACED 7/31/96.
THE CAUSE OF FAILURE IS LIKELY THE REPORTED INFECTION.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
AN APPLIER WITH A MALFUNCTION REPORT WAS MISTAKENLY SENT TO ANOTHER SITE ON 7/25/96. THEY ASKED FOR FEEDBACK ON THE ANALYSIS. QC WAS TOLD THE EVENT WAS NOT REPORTED TO CO. THE INFO CO HAD WAS TWO CLIP APPLIERS "DID NOT WORK". THEY HAD NO FURTHER INFO EXCEPT QC IN PURCHASING SENT ONE TO THEM WITH A NOTE SAYING THE CLIP APPLIER "DID NOT WORK PROPERLY WHEN BEING APPLIED TO THE INTESTINE." THE DATE ON THE NOTE FROM QC WAS 5/18/96. THE REP WAS NOTIFIED TO TRY TO GATHER INFO. 9/23/96 REP REPORTS THE ER320 MISFIRED.
A1,2,3,4;B3,6,7;D10 INFO NOT SUPPLIED. D5,6; H4 DEVICE NOT RETURNED. INFO UNAVAILABLE. H6 INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
THE INJECTION CUP REMAINED IN THE OPEN POSITION UPON DISCONNECTING FROM THE IV. NO ADVERSE REACTION, BUT THE POSSIBILITY FOR A LINE INTECTION EXISTED.
10/15/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
PT WAS UNDERGOING AN EXPLORATORY LAPAROTOMY AND ILEOCECECTOMY. FOLLOWING THE IMPROPER FIRING OF THE SUBJECT DEVICE, A MINOR SPILL OF SOME TURBID FLUID OCCURRED WHICH WAS IMMEDIATELY ASPIRATED. THE PT RECOVERED WITHOUT COMPLICATIONS AND WAS DISCHARGED.
DURING A PT TRANSPORT TO ANOTHER HOSP PER AMBULANCE, THE PUMP WENT INTO A LOW BATTERY ALERT A "FEW MINUTES" INTO THE TRANSPORT AND THE PUMP STOPPED OPERATING. THE PUMP HAD BEEN PLUGGED IN WHILE IN PREVIOUS USE. THE INFUSION PUMP WAS BEING USED FOR A NIPRIDE INFUSION AT THE TIME. THE PT'S B/P INCREASED AFTER THE PUMP STOPPED AND THE PT RECEIVED SOME TREATMENT WHEN ARRIVING AT THE RECEIVING HOSP HOWEVER, THE TYPE OF TREATMENT REQUIRED WAS NOT REPORTED AND IT IS NOT KNOWN IF IT INVOLVED MORE THAN RESTARTING THE IV DRIP. THE PT RETURNED TO PRE-INCIDENT STATUS.
THE INFUSION PUMP WAS EVALUATED BY THE REPORTING HOSP AND WAS NOT RETURNED TO CO. THE BATTERY WAS APPROX 11 MONTHS OLD. WITH THE BIOMED TESTING, THE UNIT WAS CHARGED FOR APPROX 17 HOURS. BOTH CHANNELS WERE THEN STARTED AT 50 ML/HR. THIRTY MINUTES INTO THE RUN THE LOW BATTERY ALERT WAS INITIATED. A VISUAL MESSAGE AND AN AUDIBLE TONE IS GIVEN, BUT THE DEVICE CONTINUES OPERATING AT THE PROGRAMMED RATED. SEVENTEEN MINUTES AFTER THE START OF THE LOW BATTERY ALERT THE PUMP GOES INTO A LOW BATTERY ALARM AND STOPS OPERATING. THE RUN TIME BEFORE THE INITIAL ALERT INDICATES THAT THE PUMP IS UNABLE TO HOLD AN ADEQUATE CHARGE. HOWEVER, THE DEVICE MET CO'S REQUIREMENTS OF APPROX 15 MINUTES OF OPERATING TIME FROM THE INITIATION OF THE ALERT MESSAGE UNTIL THE PUMP STOPPED OPERATING. LEAD ACID BATTERIES ARE A CONSUMABLE PART. HOW A BATTERY WAS PREVIOUSLY USED WILL IMPACT THE LENGTH OF ITS LIFE. FACTORS SUCH AS PREVIOUS DEEP DISCHARGES WITH INSUFFICIENT RECHARGING CAN GREATLY REDUCE THE BATTERY LIFE. ALTHOUGH CAUTION SHOULD BE USED WITH CRITICAL MEDICATIONS, THE IV SET USED WITH THE PUMP DOES ALLOW FOR GRAVITY ADMINISTRATION IN THE EVENT THAT A PUMP CAN NOT BE USED OR IMMEDIATELY REPLACED. THE HOSP CHANGED OUT THE BATTERY AFTER THEIR EVALUATION WAS COMPLETED.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON MANUALLY MANIPULATED THE DEVICE OFF THE APPLICATION SITE AND COMPLETED THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
IMPLANT PLACED IN 1991. DR HAD TO REMOVE IMPLANT DUE TO BONE DEGENERATION. INFECTION WAS PRESENT. DR WILL WAIT ON REPLACEMENT UNTIL PT HEALS.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO HAVE A GREENISH RESIDUE ON THE SURFACE. THE IMPLANT MET SPECIFICATIONS. THE PROBABLE CAUSE OF FAILURE IS THE REPORTED INFECTION.
AUGMENTATION ON 3/28/84 WITH SILICONE GEL IMPLANTS. LATER THE PT EXPERIENCED BILATERAL CAPSULAR FORMATION. BOTH IMPLANTS WERE COMPLETELY INCAPSULATED AND REMOVED INTACT WITHOUT RUPTURES.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. TWO DEVICES SPIT CLIPS INTO THE PT CAVITY. THE CLIPS WERE RETRIEVED. A THIRD WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
RESULTS OF EVAL: CONCLUSION-BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE CLIPS WITHIN DESIGN SPEC WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOSLY IMPROVE PRODUCTS.
RESULTS OF EVAL: CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE CLIPS WITHIN DESIGN SPEC WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS-EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
THE SAMPLE WAS DISCARDED BY THE HOSP, AND THE LOT NUMBER IS NOT KNOWN; THEREFORE, THE ROOT CAUSE FOR THE SEPARATION COULD NOT BE DETERMINED.
CALIBRATION DEFECT. NOTED ZERO MARKING ON SYRINGE DOES NOT REACH THE BASE. THEREFORE, IF YOU PULL UP DILUENT TO THE 60CC MARK, YOU ACTUALLY HAVE APPROX 65CC'S. THIS COULD AFFECT THE CONCENTRATION DISCREPANCIES WITH IV RECONSTITUTION.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED A CLIP WAS PLACED ON THE CYSTIC DUCT. A SECOND CLIP WAS ATTEMPTED BUT DID NOT FORM. THE CLIP BEHIND THE FIRST SEEMED TO FALL OUT BEHIND THE FIRST ONE. NO RIGID STUCTURE WAS CLIPPED. THIS APPLIER WAS USED FOR THE ENTIRE CASE-THE PROBLEM WAS INTERMITTENT. THERE WAS NO CONSEQUENCE TO THE PT.
PER THE INFO PROVIDED TO CO THROUGH MEANS OF THE PHYSICIAN/SURGEON'S OPERATIVE NOTES, THE DEVICE WAS REMOVED DUE TO "SEVERE SST DEFORMITY". AS STATED IN THE OPERATIVE REPORT, "POSTOPERATIVE DIAGNOSIS: MAYBE A FALSE CHANNEL IN THE DISTAL RIGHT CORPORA". DURING THE PROCEDURE, THE SURGEON STATED, "THERE WAS NO SST DEFORMITY, BUT THERE STILL WAS SOME PROTRUSION LATERAL ON THE RIGHT SIDE". THE CYLINDER(S) ONLY WERE REMOVED AND REPLACED.
EVALUATION IS PENDING DECONTAMINATION, EXAM AND TESTING OF THE RETURNED DEVICE COMPONENT(S). FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVALUATION WILL BE FORWARDED UPON COMPLETION.
DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
DURING PAST 2 YRS USER HAS HAD REPEATED PROBLEMS WITH THE PRODUCT. UNIT STOPS UNEXPECTEDLY WHILE IN USE BY PTS. NO INJURIES HAVE OCCURRED BUT THE POTENTIAL EXISTS. BIOMED DEPT HAS MADE NUMEROUS ATTEMPTS TO CORRECT THE PROBLEM BASED ON MFR INPUT. NO PTS EXCEEDED THE RECOMMENDED WEIGHT LIMIT AND MOST WERE OF AVERAGE BUILT. INITIALLY RPTR HAD (2) UNITS BUT NOW ONLY 1 IS AVAILABLE OR 1ST ONE IS UNAVAILABLE - UTILIZED FOR SCRAP AND PARTS. IT WAS USED FOR SCRAP PARTS. ADD'L EVENT DATES 1995 AND 1996.
THE DEVICE WAS APPLIED DURING AN AORTIC ANEUR. REPORTEDLY, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING AN L.A.V.H. THE DEVICE WITH VASCULAR CARTRIDGE WAS USED TO STAPLE AND CUT ACROSS THE IP LIGAMENT. THE PT'S SIDE STAPLE LINE STAPLED HALFWAY AND CUT ALL THE WAY. A VESSEL WAS BLEEDING (GRADE 4) AND CLIPS WERE USED TO ACHIEVE HEMOSTASIS. THE DEVICE WAS NOT SAVED. THE CARTRIDGE WAS COLLECTED BY THE ENGINEER FOR FURTHER ANALYSIS. THERE WAS NO CONSEQUENCE TO THE PT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE WOULD NOT OPEN AFTER PLACING A CLIP ON THE CYSTIC DUCT. AFTER FIRING THE DEVICE AGAIN, THE DEVICE WOULD RELEASE THE CLIP, AFTER SPITTING ANOTHER CLIP BEHIND IT. THERE WAS NO CONSEQUENCE TO THE PT.
9/18/96 1544 OFFICE CLOSED. LEFT PM MESSAGE AND 800# FOR DR. REQUESTING FOLLOW UP. TSB9/19/96 NNCL SENT. KJBD5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
LEAKING AROUND THE NEEDLE ON MORE THAN ONE OCCURRENCE.
NO SAMPLES RECEIVED. PERFORMED MAGNIFIED VISUAL (10X) ON 15 RETENTIONS; 015 SHOWED ABNORMALITIES. LEAKAGE WAS ALSO PERFORMED; 0/15 LEAKED. NO PROBLEMS NOTED DURING MFR. NO PREVIOUS COMPLAINTS RECEIVED FOR THIS LOT.
THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A CO MALLEABLE PENILE PROSTHESIS.
TWO CYLINDERS AND A PUMP WERE RECEIVED BY AND EVALUATED BY MFR. DEVICE PASSED ALL FUNCTIONAL TESTS. HOWEVER, OBVIOUS DAMAGE WAS SEEN IN NON-SERIALIZED OUTLET. A MICROSCOPIC EXAMINATION OF TUBING ENDS WAS PERFORMED. NON-SERIALIZED TUBING ENDS WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. OUTER LAYER OF TUBING WAS DETACHED ALL WAY AROUND TUBING. FOUR PORTIONS OF MONOFILAMENT WERE EXPOSED. AREAS ON MONOFILAMENT WERE DISCOLORED BROWN AND HAD EITHER MISSING OR MOVED MATERIAL, SUGGESTING EXPOSURE TO A HOT INSTRUMENT, SUCH AS AN ELECTROCAUTERY DEVICE. BASED ON RECEIVED INFO AND QUALITY ASSURANCE'S EXAIMINATION, QA CONCLUDES THAT TUBING TORE. THIS TEAR, WHILE IN-VIVO WOULD CAUSE A FLUID LOSS FROM DEVICE, AND CAUSE A DEVICE MALFUNCTION. STRESS(ES) ASSOCIATED WITH DEVICE USABE OVER TIME, AND POSSIBLY DEVICE POSITIONING CAUSED TUBING TEAR. QA ALSO CONCLUDES THAT INSTRUMENT DAMAGE OCCURRED DURING OR SUBSEQUENT TO EXPLANT, AND THUS IS NOT RELATED TO REPORTYED MALFUNCTION.
PT BEING DIALYZED ON 10/1/96 WHEN IT WAS NOTICED THAT THE MACHINE WAS TAKING OFF TOO MUCH WEIGHT. THE MACHINE WAS TAKEN OUT OF SVC AND TESTED BY BIO-MED. WITH NO PROBLEMS FOUND. THE MACHINE WAS PUT BACK IN USE ON 10/2/96 ON A DIFFERENT PT WITH THE SAME INCIDENT AGAIN OCCURRING. THE MACHINE WAS TAKEN OUT OF USE AND THE MFR NOTIFIED. ADD'L PT INFO AGE: 58, DATE OF BIRTH: 10/10/37, WEIGHT: 97 KG.
DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
IT WAS REPORTED THAT WHILE DELIVERING PITOCIN THE NURSE NOTED THAT THE PUMP WAS IN ALARM AND FLUID WAS DELIVERING FASTER THAN THE SET RATE.
PUMP WAS NTO RETURNED TO THE MFR FOR EVALUATION. THE HOSPITAL'S BIOMED TESTED THE PUMP AND NO FAULT WAS FOUND. THE HOSPITAL SUSPECTS POSSIBLE MISLOAD OF THE SET. ADDITIONAL INSERVICING WILL BE PERFORMED ON THE PROPER PROCEDURE FOR LOADING OF THE IV SET PER THE DIRECTIONS FOR USE, PAGE 9, WHICH STATES, "DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH."
PER THE INFO PROVIDED TO CO THROUGH ITS INTERNATIONAL REP, THE DEVICE WAS REMOVED DUE TO "FRACTURE OF TUBING", SECONDARY TO A "FLUID LOSS". THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 2-PIECE INFLATABLE PENILE PROSTHESIS.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 12/20/89 AND REMOVED ON 8/7/96 DUE TO "FLUID LOSS" SECONDARY TO A "TUBING FRACTURE." A RESIPUMP AND TWO CYLINDERS WERE RETURNED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A COMPLETE SEPARATION OF OUTLET #1'S EXITING TUBE, CONFIRMING THE DR'S OBSERVATIONS OF A "TUBING FRACTURE." EXAMINATION OF THE SURFACES OF THE SEPARATION, BOTH ON THE OUTLET AND CYLINDER SIDE, REVEALED MARKINGS CHARACTERISTIC OF STRESS(S) INDUCED RENDING. THE OBVIOUS SEPARATION OF COMPONENTS AT THIS SITE WOULD ALLOW LEAKAGE, FURTHER CONFIRMING THE DR'S OBSERVATIONS OF "FLUID LOSS." BASED ON QA'S EXAMINATION AND THE DR'S OBSERVATIONS, QA CONCLUDED THAT WHILE IN-VIVO, SUFFICIENT STRESS(S) WERE EXERTED TO REND THE TUBING AT THE NOTED SITE. THIS RENT WOULD ALLOW THE LOSS OF FLUID, RENDERING THE DEVICE INOPERABLE.
RPTR HAS USED THIS PRODUCT FOR SEVERAL MONTHS AND EXPERIENCED PERSISTENT POOR GLOVE QUALITY. VERY THIN LATEX IS USED RESULTING IN EASY TEARING. NUMEROUS GLOVES COME OUT OF THE BOX WITH HOLES IN THEM EVEN WITH INCOMPLETE FINGERS. THIS HAS LED TO SKIN EXPOSURE TO BLOOD AND BODY SECRETIONS.
IT WAS REPORTED THAT DURING A PTCA PROCEDURE, DIFFICULTY WAS ENCOUNTERED DEFLATING THE BALLOON. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED RESIDUAL DRIED CONTRAST MEDIA AND BLOOD PRESENT THROUGHOUT THE SHAFT OF THE CATHETER. DUE TO THE CONDITION OF THE SHAFT, TESTING RELATIVE TO THE REPORTED DEFLATION DIFFICULTIES COULD NOT BE PERFORMED. NO MATERIAL OR MFG DEFICIENCIES WERE NOTED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE WAS NOT HOLDING CLIPS IN JAWS AND WAS CAUSING CLIPS TO SCISSOR WHEN FIRED. ANOTHER ER320 WAS OPENED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT. 9/20/96 THE CLIPS FELL INTO THE PT AND WERE RETRIEVED BY THE SURGEON.
FILTER WAS PLACED IN CONJUCTION WITH AN INFUSION DEVICE DELIVERING MEDICATION AT A RATE OF 7ML/HR THROUGH AN EPIDURAL CATHETER. THE FILTER WAS FOUND TO BE LEAKING AT A POINT WHERE THE TUBING OF THE FILTER SET EXITS THE PLASTIC FILTER HOUSING. ON CALL NURSE REPLACED THE FILTER WITH A SIMILAR UNIT OF THE SAME LOT # WITHOUT PROBLEMS. THE PT IS RECEIVING EPIDURAL PAIN CONTROL THERAPY IN THEIR HOME. EXPIRATION DATE: 7/00.
PER THE INFO PROVIDED TO CO THROUGH CO'S INTERNATIONAL REP, THE PHYSICIAN/SURGEON REPORTED THAT THE DEVICE WAS REMOVED DUE TO A "FAILURE TO INFLATE".
ENTIRE DEVICE WAS RECEIVED AND EVALUATED BY MFR. DEVICE PASSED ALL FUNCTIONAL TESTS. HOWEVER, DURING MICROSCOPIC EXAMINATION, TWO TUBING TEARS WERE LOCATED IN ONE OF CYLINDERS. ONLY ONE OF TEARS COMPROMISED INNER AND OUTER LAYER OF TUBING. THUS, ONLY ONE OF TEARS RESULTED IN LEAK. CROSS SECTIONAL SURFACES OF THIS SEPARATION SITE WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. A TUBING INDENTATION CONSISTENT WITH SIZE, SHAPE, AND LOCATION OF A TUBING INDENTATION CAUSED BY A CONNECTOR APPENDAGE WAS NOTICED NEAR THIS LEAKAGE SITE. SPACING BETWEEN INDENTATION AND LEAKAGE SITE DEMONSTRATES THAT A CONNECTOR APPENDAGE WAS LOCATED AT LEAKAGE SITE. OTHER TUBING TEAR COMPROMISED ONLY OUTER LAYER OF TUBING, AND THEREFORE DID NOT NOTICEABLY LEAK. CROSS SECTIONAL SURFACES OF THIS SEPARATIONSITE WERE ALSO ROUGH AND IRREGULAR, ALSO INDICATING A TUBING TEAR. AN AREA OF ABRASION WAS LOCATED AROUND THIS TEAR. PUMP OUTLET TUBES WERE RECEIVED IN A BENT POSITION. TUBES WERE NOTICEABLY BENT SUPERIORLY (TOWARD SERIALIZED OUTLET.) POSITIONING OF RECEIVED TUBES, INDICATED THAT TUBES WERE IN A BENT POSITION FOR AN EXTNEDED PERIOD OF TIME WHILE IN-VIVO. BASED ON RECEIVED INFO AND QUALITY ASSURANCE'S EXAMINATION, QA CONCLUDES THAT A TUBING TEAR, THAT WOULD HAVE LEAKED IN-VIVO WAS CAUSE FOR REPORTED FAILURE TO INFLATE. FUTHERMORE, DEVICE'S POSITIONING WHILE IN-VIVO MOST LIKELY CONTRIBUTED TO STRES(ES) AT CONNECTOR SITE CAUSING TUBING TEAR/LEAKAGE SITE.
THE DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPY. PRIOR TO THE START OF THE CASE THE SCRUB TECH TRIED TO ACTIVATE THE DEVICE. EITHER THE TROCAR WOULD NOT STAY ACTIVATED OR THE SAFETY SHIELD WOULD NOT RETRACT. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT'S RESET BUTTON "WOULD NOT STAY ACTIVATED" DURING SURGERY. THE INSTRUMENT'S ENDCAP WAS OBSERVED TO HAVE BEEN WELDED EXCESSIVELY TO THE HANDLE WHICH MAY HAVE CAUSED THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS. THE ASSEMBLE LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
THE FILTER HEATER WOULD NOT HEAT. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND REPLACED THE FILTER HEATER ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE HEATER MALFUNCTION, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
COLLIMATOR ACCESSORY LATCH FAILED DURING GANTRY MOVEMENT CAUSING THE WEDGE MOUNT TRAY AND BLOCK MOUNT TRAY TO FALL TO THE FLOOR. A PT WAS ON THE TREATMENT TABLE AND THE TRAYS BARELY MISSED THE PT. A SVC BULLETIN WAS ISSUED BY MFR REGARDING A PROBLEM OF THIS NATURE. IT CALLS FOR THE PARTS TO BE INSPECTED AT THE TIME OF A PM AS A MINIMUM. A PM WAS DONE SEVEN DAYS PRIOR TO THIS INCIDENT. THIS BULLETIN WAS ISSUED 12/28/89 AND THERE HAS BEEN NO ATTEMPT THAT RPTR IS AWARE OF TO CORRECT THE DEFECT. (*)
ON 9/11/96, THE ACCOUNT STATES A PT'S URINE SAMPLE GAVE A POSITIVE RESULT YET THE DR STATED THE PT CLINICALLY DID NOT PRESENT POSITIVE SIGNS OF PREGNANCY. THE PT'S BLOOD WAS DRAWN AND A SERUM BETA HCG WAS DONE AT A REFERENCE LAB FOR A NEGATIVE RESULT AT LESS THAN 5 MLU/ML. THE URINE SAMPLE WAS A RANDOM SAMPLE. THE ACCOUNT STATED THE PT DELIVERED A CHILD 6 MONTHS AGO AND WAS IN FOR HER ROUTINE 6 MONTH CHECK-UP. THE PT IS NOT ON ANY MEDICATIONS. HER LAST MENTSTRUAL PERIOD WAS 3 WKS PRIOR TO VISIT WHICH WAS 9/10 OR 9/11. THE ACCOUNT HAS NO URINE OR SERUM FOR RETURN.
CHILD IN FOR TEST. BALLOON INFLATED WITH WATER. CONTRAST DYE INSERTED INTO PT. PICTURES TO BE TAKEN AND CATHETER TO BE REMOVED SO PT COULD VOID ON OWN AND BE FURTHER TESTED FOR URETERER PROBLEMS. BALLOON WOULD NOT DEFLATE. CATHETER HAD BEEN CLAMPED WHERE STYLET IS LOCATED. TRIED SEVERAL WAYS TO DEFLATE BALLOON, BUT PROBLEM SEEMED TO BE FURTHER UP CATHETER AWAY FROM VALVE END. CATHETER WAS CUT IN HALF AND PULLED FROM CHILD. NO INJURY TO PT.
200 PRODUCT HAD BEEN CLAMPED BY USER CAUSING NON DEFLATION OF BALLOON.
AT START OF DRAINAGE DR NOTED ERROR IN TUBING AND NOTED POSSIBILITY OF LEAK IN TUBING. TUBING BYPASSED FOR THE REMAINDER OF THE PROCEDURE AND THERE WAS NO MORE ERROR APPARENT IN DRAINAGE. TUBING FLUSHED BY DR WITH NORMAL SALINE AFTER PROCEDURE AND LIQUID NOTED ON OUTSIDE OF TUBING. PT TAKEN FOR STAT X-RAY. NO PNEUMOTHORAX NOTED.
A VISUAL AND LEAK INSPECTION WERE PERFORMED. THERE WERE NO LEAKS NOTED IN THE UNIT. IT WAS NOTED THAT THE CATHETER GUARD WAS STILL IN PLACE. THE DIRECTIONS FOR UNIT STATE: "HOLD HUB AND ADVANCE "Y" UNTIL FLUID CAN BE ASPIRATED THROUGH CATHETER. WITHDRAW INTRODUCER NEEDLE FROM THORACIC WALL UNTIL IT ENGAGES AND LOCKS TOGETHER WITH THE "Y." PLACE GUARD OVER THE NEEDLE TO PROTECT FROM ACCIDENTALLY BEING CUT. DISCARD TUBE. IT IS IMPERATIVE THAT THE DIRECTIONS ARE FOLLOWED IN ORDER TO PREVENT LEAKS AND ACCIDENTAL SEVERANCE OF THE CATHETER. A DEVICE HISTORY  SEARCH WAS CONDUCTED USING THE LOT NUMBER LISTED ABOVE, THERE IS NO INFO THAT WOULD INDICATE A PROBLEM WAS FOUND EITHER IN PRODUCTION OR RAW MATERIAL INSPECTIONS.
THE INSTRUMENT WAS USED DURING A BOWEL RESECTION. IT WAS REPORTED THE CLIPS WERE NOT CLOSING PROPERLY. THIS INSTRUMENT WAS USED FOR THE ENTIRE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
THE APPLIER WAS RECEIVED WITH A PARTIALLY FORMED CLIP IN THE JAW. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT DURING SURGERY. THE APPLIER WAS RECEIVED WITH A PARTIALLY FORMED CLIP IN THE JAWS. THE APPLIER WAS CYCLED AND THE FIRING STROKE WAS COMPLETED AND THE PARTIALLY FORMED CLIP IN THE JAWS THEN SCISSORED. THE APPLIER THEN CYCLED AND FIRED THE REMAINING 9 CLIPS WITHOUT INCIDENT AND WITHIN DESIGN SPECIFICATION. IT WAS CONCLUDED THAT THE APPLIER WAS CONFORMING TO DESIGN SPECIFICATIONS. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
PT RECEIVING VANCOMYCIN VIA PUMP. VANCOMYCIN PROVIDED IN MINIBAG AND INFUSED VIA SET. VANCOMYCIN BAG, TUBING AND PUMP PLACED IN CARRYING CASE. DUE TO "KINK" IN TUBING ANTERIOR TO PUMP, PT MISSED 2 DAYS OF THERAPY. PUMP CONTINUED TO RUN WITHOUT ALARMING.
THE INSTRUMENTS WERE USED DURING A THORACOSCOPY. IT WAS REPORTED THE SURGEON HEARD A CRACK UPON FIRING THE DEVICE AND THE INSTRUMENT MISFIRED. SURGEON ALSO USED ANOTHER DEVICE AND UPON FIRING COULD NOT GET THE HANDLES OPENED. THERE WAS NO CONSEQUENCE TO THE PT.
CO 0964803-1. A1,2.3,4; B6,7; D10 CONTACTED SURGEON . INFO NOT AVAILABLE. D5; H4,6 INFO NOT AVAILABLE AT THIS TIME. BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. THE RETURNED CARTRIDGE WAS BROKEN AT THE TISSUE GAG SPACING PIN. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO "NON-FUNCTION", SECONDARY TO "BROKEN TUBING AT PUMP". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER PIECE INFLATABLE PENILE PROSTHESIS.
THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 6/10/88 AND REMOVED ON 9/19/96 DUE TO "BROKEN TUBES AT PUMP," "NON-FUNCTIONING." A RESIPUMP AND TWO CYLINDERS WERE RETURNED FOR EVAL. IN THE RECEIVED INFO THE MD STATED THAT FLUID WAS LOST FROM THE DEVICE FROM A "BROKEN CONNECTING TUBING FROM PUMP (TO) CYLINDERS." EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A SEPARATION/LEAKAGE SITE IN OUTLET #1'S EXITING TUBE NEAR THE STRAIN RELIEF/TUBE JUNCTION. EXAMINATION OF THE SURFACES OF THE SEPARATION REVEALED MARKINGS CHARACTERISTIC OF STRESS(S) INDUCED RENDING. AN AREA OF ABRASION IS OBSERVED SURROUNDING AND PENETRATING THE SEPARATION AND EXTENDING UNTO THE STRAIN RELIEF. A CREASE MARK IS NOTED OPPOSITE THE SEPARATION ON THE ANTERIOR SURFACE OF THE TUBE. FURTHER EXAMINATION REVEALED AN AREA OF ABRASION ANTERIORLY LOCATED ON OUTLET #2'S STRAIN RELIEF AND EXITING TUBING. IN ADDITION, BOTH OUTLET ARE NOTED TO CURVE TOWARD EACH OTHER. THIS, AND THE PATTERN OF ABRASION NOTED ON THE TWO OUTLETS, INDICATES THAT THE OUTLETS WERE OVERLAPPED WHILE IN-VIVO. IN ADDITION A SEPARATION IS NOTED IN OULET #2'S EXITING TUBE AT THE STRAIN RELIEF/TUBE JUNCTION, CONFIRMING THE REPORT OF "BROKEN TUBES AT PUMP," HOWEVER THIS SEPARATION EXTENDS THROUGH THE FIRST TUBE LAYER ONLY AND IS NOT A SITE OF LEAKAGE. BASED ON QA'S EXAMINATION AND THE MD'S OBSERVATIONS, QA CONCLUDED THAT WHILE IN-VIVO OUTLET #1 AND OUTLET #2 WERE OVERLAPPTED AND ABRADING AGAINST ONE ANOTHER. IN ADDITION, OUTLET #1'S EXITING TUBE WAS PARTIALLY KINKED. QA FURTHER CONCLUDED THAT THIS POSITIONING, COMBINED WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBING AT THE NOTED SITE. THIS SEPARATION WOULD ALLOW THE LOSS OF FLUID, RENDERING THE DEVICE INOPERABLE.
PT WAS NOTED TO BE HOLDING THE EXTERNAL (DISTAL) SECTION OF AN INDWELLING CATHETER IN HIS HAND. THE PROXIMAL SECTION OF THE CATHETER (THE PART WITH INFLATED BALLOON) WAS MISSING. A THOROUGH SEARCH OF BED LINENS AND PT AREA FAILED TO LOCATE MISSING SECTION OF CATHETER.
THE CUSTOMER WAS UNABLE TO GET THE DEFIBRILLATOR TO DISCHARGE ONCE THE CHARGE DONE TONE WAS AUDIBLE.
H6-CONCLUSION: CO HAS NOT YET RECEIVED THE DEVICE TO BE EVALUATED. AT THIS TIME CO HAS ONLY A VERY SKETCHY REPORT OF AN ALLEGED FAILURE. CO IS ATTEMPTING TO GET MORE INFO THROUGH THEIR FIELD ORGANIZATION AND A DISTRIBUTOR. CO WILL FILE AN UPDATE WHEN THEY HAVE MORE INFO.
WHEN PREPARING TO DISCONTINUE INFUSION PUMP THE CLINICIAN NOTED THAT THE MEDICATIONS ADRIAMYCIN AND VINCRISTINE HAD NOT INFUSED. VOLUME INFUSED SHOWED "00" AND CASSETTE APPEARED FULL. THE PHYSICIAN WAS NOTIFIED AND INFUSION PUMP WAS TAKEN OUT OF SVC AND SENT TO BIOMEDICAL ENGINEERING FOR INSPECTION.
CATHETER SHOWED NO SIGNS OF WEAKNESS OR MATERIAL DEGRADATION BUT APPEARED TO BE SLICED/CUT BEFORE IT WAS BROKEN INTO 2 PCS. SUSPECTED THE PROBLEM MAY HAVE OCCURRED DURING CATHETERIZATION. THE EXTERNAL SURFACE OF THE "CUT" WAS SMOOTH AND SHARP; TYPICALLY OF AN INCISION CAUSED BY A SHARP DEVICE SUCH AS A BLADE USED IN THE ATTEMPT TO REMOVE THE PRODUCT DURING USE. CATHETER BROKE INTO 2 PCS. WHEN PRESSURE WAS APPLIED. THE EDGES OF THE INTERNAL LAYER WERE IRREGULAR INDICATING A PULLING FORCE. THIS MAY HAVE CAUSED BY PT ATTEMPTING TO REMOVE THE CATHETER.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY  QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE WOULD NOT OPEN AFTER PLACING A CLIP ON THE CYSTIC DUCT. AFTER FIRING THE DEVICE AGAIN, THE DEVICE WOULD RELEASE THE CLIP, AFTER SPITTING ANOTHER CLIP BEHIND IT. THERE WAS NO CONSEQUENCE TO THE PT.
H6; BENT SHAFT. PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF DEVICE WHICH WAS RETURNED. RESULTS OF INVESTIGATION CONDUCTED BY APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CLIP IN JAW, NO; CONDITION OF HANDLE HALVES, GOOD; CRIMP LOCATION, GOOD; JAW CONDITION, GOOD; JAW POSITION, OPEN; NUMBER OF CLIPS, N/A AND SHAFT CONDITION, BENT. FUNCTIONAL TESTS & RESULTS: COULD INSTRUMENT BE CYCLED, NO AND NUMBER OF CLIPS FIRED, N/A. ANALYSIS CONCLUSION: BASED UPON INQUIRY INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT WAS RETURNED WITH SHAFT BENT AT APPROXIMATELY 70 DEGREE ANGLE. NO TESTING COULD BE PERFORMED DUE TO CONDITION OF INSTRUMENT RETURNED. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THIS INQUIRY WAS ORIGINALLY REPORTED AS RPO "RECORD PURPOSE ONLY."
THE UNIT WAS PROGRAMMED FOR A TOTAL VOLUME OF 1800 ML AND WHEN THE TPN WAS COMPLETE, THE TOTAL DELIVERED DISPLAY SHOWED 3000 ML. EACH INDIVIDUAL VOLUME DISPLAY SHOWED THAT IT DELIVERED EXACTLY WHAT WAS PROGRAMMED. THERE WAS NO PT INVOLVEMENT. THE UNIT WAS RETURNED FOR EVAL.
SECTION F COMPLETED BY CO BASED ON INFO OBTAINED FROM THE REPORTER. EVAL: THE UNIT WAS RECEIVED DIRTY AND TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
OVER THE COURSE DATES 9/30 - 10/1/96 PT WAS TO RECEIVE VANCOMYCIN 1GM OVER 90 MINS OF 24 HRS VIA INFUSION PUMP  WITH A CONCENTRATION OF 10MG/ML SOLUTION. UPON BAG CHANGE DURING NURSING VISIT, IT WAS DISCOVERED THAT ONLY 90CC WAS INFUSED OVER 2 DAYS, INSTEAD OF 200CC/48 HRS. THEREFORE, PT ONLY RECEIVED 900 MG IN A 48 HR OF TIME. SAME PUMP APPEARED TO WORK WITH FUTURE DOSES.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIM X-TUBE BROKE AT THE BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DIES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CO WAS NOTIFIED OF THIS ALLEGED EVENT VIA A PETITION SUPPLIED BY AN ATTORNEY FOR THE PT. NO OTHER INFO IS AVAILABLE CONCERNING THIS MATTER. ON 11/30/94, THE PT WAS ADMITTED TO A MEDICAL FACILITY WHERE SHE UNDERWENT A DECOMPRESSION LAMINECTOMY PROCEDURE. FOLLOWING THE PROCEDURE, THE PT WAS DIAGNOSED WITH DVT AND PE. ON 12/21/94 A VENA CAVA FILTER WAS INSERTED. THE PT WAS DISCHARGED ON 1/5/95. ON 3/17/95, THE PT WAS ADMITTED TO ANOTHER FACILITY FOR ACUTE CHOLECYSTITIS. ON 3/20/95, PT BECAME SEPTIC AND WENT INTO SHOCK. SHE WAS SUBSEQUENTLY DIAGNOSED WITH A MASSIVE RETROPERITONEAL HEMORRHAGE AND LACERATIONS OF THE IVC AND AORTA. AS A RESULT, THE PT UNDERWENT EMERGENCY EXPLORATORY LAPAROTOMY, REPAIR OF AORTIC LACERATION, VENA CAVA LACERATION AND LIGATION OF IVC. THE PT'S CONDITION DETERIORATED AND SHE DEVELOPED RESPIRATORY FAILURE, ACIDOSIS, HYPOTENTENSION AND SHOCK. ON 3/21/95, THE PT EXPIRED.
NO PRODUCT WAS RETURNED FOR EVALUATION. CO WAS WARN IN ITS LABELING THAT FILTER MIGRATION AND PERFORATION OF THE VENA CAVA WALL MAY OCCUR.
INFO WAS PROVIDED BY THE DEPT OF HEALTH AND HUMAN SERVICES THAT INDICATES THE CUSTOMER REPORTED VIA MEDWATCH THAT THE VENTILATOR ALLEGEDLY SHUT DOWN DURING OPERATION. THE PT WAS REPORTEDLY REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED WHILE A NEW UNIT WAS SET UP. THE CUSTOMER REPORTED NO APPARENT PT INJURY. BECAUSE THE CUSTOMER AND VENTILATOR INFO WAS NOT PROVIDED, SPECIFIC DETAILS CANNOT BE VERIFIED OR INVESTIGATED. IT IS NOT VERIFIED THAT THE UNIT SHUT DOWN AS REPORTED AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
X-FRAME. DEALER CLAIMS: X-FRAME SNAPPED AT CENTER HOLE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
VASCULAR PROSTHESIS (CATALOG #631608 AND LOT #14254) WAS SUCCESSFULLY IMPLANTED DURING A ROUTINE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT AND TWO UNITS OF BLOOD WERE ADMINISTERED. FIVE  HRS AFTER THE PROCEDURE WAS COMPLETED, THE PT DEVELOPED VASOPARALYSIS AND SUFFERED A SIGNIFICANT DROP IN BLOOD PRESSURE. THE PT WAS PLACED IN INTENSIVE CARE FOR TWO WEEKS AND SPENT SUBSEQUENT THREE DAYS IN INTERMEDIATE CARE. THE IMPLANTING SURGEON REPORTED THAT THE PT DIED TWENTY DAYS AFTER THE OPERATION DUE TO COMPLICATIONS FROM A CANDIDA INFECTION.
THE INVESTIGATION FAILED TO ESTABLISH A RELATIONSHIP BETWEEN THE PROSTHESIS AND THE DEATH OF THE PATIENT. AT THE TIME OF WRITING NO OTHER INCIDENT OF THIS TYPE HAS BEEN REPORTED TO SULZER VASCUTEK. IT CAN BE REASONABLY ASSUMED THAT ALL GRAFTS FROM THIS BATCH HAVE NOW BEEN IMPLANTED. THE LENGTH OF TIME TAKEN TO SUBMIT THIS FINAL REPORT WAS EXTENDED DUE TO THE FACT THAT THE INFO FROM THE HOSPITAL WAS NOT FORTHCOMING AND THE FACT THAT THE REPORTING SURGEON HAS SINCE LEFT SURGICAL PRACTICE. THE SURGEON DID COMMUNICATE TO SULZER VASCUTEK THAT SHE HAD SEEN THE RESULTS OF OUR INVESTIGATION AND THAT NO FURTHER ACTION FROM SULZER VASCUTEK IS NECESSARY.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED DURING 9/96. IT WAS REPORTED THE DEVICE WAS FIRED ON THE ADNEXA AND BROAD LIGAMENT. ON THE FIRST AND SECOND FIRINGS, THE DEVICE STAPLED HALFWAY. A SECOND DEVICE WAS INTRODUCED AND USED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.
9/23/96 1306 MESSAGE AND 800# LEFT FOR MD CALL BACK. 1325 DR. CALLED BACK AND STATED THE FIRST FIRING WAS OK, THE SECOND FIRING "FELT A LITTLE ROUGH," AND THE THIRD FIRING WOULD NOT FIRE AT ALL. A NEW INSTRUMENT WAS OPENED TO COMPLETE THE CASE. A1,2,3,4,B3,6,7,D10-INFO NOT PROVIDED BY USER FACILITY. H4,D5,6-INFO NOT AVAILABLE. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INCIDENT MAY HAVE BEEN CAUSED BY DAMAGE TO THE INTERNAL COMPONENTS. THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND WAS FOUND TO HAVE A BENT KNIFE. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
QR AXLE WITH NUT. DEALER ALEGES QR AXLE NOT RELEASING, BALL BEARINGS MISSING.
STAKING AT HOLE NOT SUFFIENCT TO RETAIN DETENT BALL. THIS REPORT WAS DELAYED DUE TO INACCURATE INFO. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OR THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT TH4E DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CASTER HINGE R, CASTER HINGE L. DEALER CLAIMS CASTER HINGES ARE BUSTED.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. IT WAS REPORTED THE DEVICE WAS FIRED BY THE RESIDENT. A CRUNCH WAS REPORTED TO HAVE BEEN HEARD, AND UPON REMOVAL, THE KNIFE HAD CUT A DONUT, BUT THE DEVICE DID NOT STAPLE THE ANASTOMOSIS. STOOL LEAKED INTO THE PELVIS. THE SURGEON HAD SEWED THE ANASTOMOSIS AND THE PELVIC CAVITY WAS FLUSHED EXTENSIVELY. THE DEVICE WAS INSPECTED ON THE BACK TABLE, AND SURGEON ATTEMPTED TO FIRE THE DEVICE AT THE BACK TABLE. THERE WAS NO CONSEQUENCE TO THE PT.
D5; H4,6 INFO NOT AVAILABLE AT THIS TIME.
WOUND DEHISCENCE OCCURRED THREE DAYS FOLLOWING A PFANNENSTIEL INCISION CAESAREAN. SUTURE WAS USED TO CLOSE THE MUSCLE LAYER. APPARENTLY, THE SUTURE SNAPPED CLEANLY IN THE MIDDLE OF THE INCISION. THERE WAS NO EVIDENCE OF FRAYING, HOWEVER, THE DR DID NOT KEEP THE SUTURE. REOPERATION FOR REPAIR OF THE RECTUS SHEATH WAS NECESSARY. THE PT IS DOING WELL FOLLOWING REOPERATION.
CODE 81- SAMPLES RECEIVED, INVESTIGATION IS IN PROGRESS. REFERENCE MFR COMPLAINT # H96-037. PLEASE NOTE THAT THIS REPORT MAY BE USED UPON INFO NOT YET VERIFIED BY CO AND TO BE COMPLETE AN ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
REMOTE BOX W/S/A ARM R. DEALER CLAIMS THE MOTHER SAID THE CHAIR JUST TOOK OFF. POSSIBLE WATER DAMAGE.
MONITORING OF DEVICE FOR ANY REOCCURRANCE. THIS REPORT OR OTHER INFO SUBMITTED BU QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSAION OR ADMISSION BY QUYICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE INSTRUMENTS WERE USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THE INSTRUMENTS WOULD NOT ARM PROPERLY IN TEST BY OR SCRUB. ANOTHER TROCAR WAS OPENED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6; D10 CONTACTED CONTACT PERSON. NO INFO WAS AVAILABLE. D5; H4,6 INFO NOT AVAILABLE AT THIS TIME. BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS DETERMINED THAT THE INSTRUMENT ARMED INTERMITTENTLY. THE ENDCAP WAS OBSERVED TO HAVE BEEN WELDED EXCESSIVELY TO THE HANDLE WHICH MAY HAVE CAUSED THE REPORTED INCIDENT. APPROPRIATE ENGINEERING AND MFG PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.
PT IN A WHEELCHAIR BELT SLIPPED DOWN SO THAT THE BELT WAS UP AROUND HIS NECK. PT WAS CYANOTIC AND NOT BREATHING. CPR WAS STARTED AND THE PT WAS TRANSFERRED TO THE HOSP.
THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS OR RELATIONSHIP TO THE PRODUCT. CO IS JUST RESPONDING TO THIS EVENT AS REQUIRED BY LAW. AFTER THE INCIDENT THE FACILITY PUT THE SUBJECT PRODUCT BACK INTO STOCK. THEREFORE, CO IS UNABLE TO EVALUATE IT.
CUSTOMER REPORTED THAT THE 3100A HAD AN UNSTABLE MAP THAT WOULD FLUCTUATE 3 TO 4 CM H20. A REPLACEMENT RENTAL 3100A VENTILATOR WAS SENT TO THE CUSTOMER SO THIS UNIT COULD BE RETURNED TO THE FACTORY FOR ANALYSIS. THE PT WAS NOT COMPROMISED AT ALL.
DEVICE PMA# P890057. IS FREQUENCY ADDRESSED IN LABELING?N. IF "NO" - FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "NO"- SEVERITY GREATER THAN USUAL? UNK. THE UNIT WAS RETURNED TO THE FACTORY FOR ANALYSIS. IT WAS DETERMINED THAT A TUBE IN THE PNEUMATICS ASSEMBLY WAS LEAKING. THE ANALYSIS HAS BEEN COMPLETED. REFER TO THE ATTACHED PRODUCT EVAL: THE UNIT WAS VISUALLY INSPECTED FOR DEFECTS AND TESTED PER THE PRODUCTION TEST PROCEDURE 767140 AND THE RENTAL TEST/INSPECTION PROCEDURE IP-767996. NO DEFECTS WERE PRESENT DURING THE VISUAL INSPECTION. WHILE THE VENTILATOR WAS RUNNING, IT WAS OBSERVED THAT THE MAP WAS UNSTABLE. IT WAS FOUND THAT THE BRAIDED TUBING THAT RUNS FROM THE PRESSURE SWITCH TO THE MANIFOLD IN THE PNEUMATICS ASSEMBLY WAS LEAKING. THE COMPLAINT WAS VERIFIED. THE LEAK IN THE BRAIDED TUBING CAUSED THE MAP TO BEOME UNSTABLE. THE BRAIDED TUBING WAS REPLACED AND THE PRODUCTION TEST PROCEDURE 767140 AND THE RENTAL TEST/INSPECTION PROCEDURE IP-767996 WAS PERFORMED.
CO 964798-2. A1,2,3,4; B6,7; D10 CONTACTED CONTACT PERSON. INFO NOT AVAILABLE. D5; H4,6 INFO NOT AVAILABLE AT THIS TIME. BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT "WOULDN'T ARM" DURING SURGERY. THE INSTRUMENT'S ENDCAP WAS DISASSEMBLED AND THE KNIFE COLLAR FOUND TO BE BENT WHICH MAY HAVE CAUSED THE REPORTED INCIDENT. NO CONCLUSION COULD BE REACHED AS TO HOW THE KNIFE COLLAR HAD BECOME BENT. APPROPRIATE ENGINEERING AND MFG PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.
A 50 ML BAG OF NS WAS PROGRAMMED TO INFUSE OVER ONE HR, HOWEVER, THE AMOUNT WAS DELIVERED IN ONLY 30 MINUTES. NO PT INJURY WAS REPORTED. NO ADD'L SPECIFIC INFO WAS RECEIVED.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY: FLOW ACCURACY TESTING WAS PERFORMED ON BOTH PUMP CHANNELS AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION.
THE SCREWS ARE LOOSENING DURING USE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
DEVICE NOT MFG IN THE US. DEVICE RETURNED DIRECTLY TO MFR. EVAL WAS PERFORMED AT MFG FACILITY. SUMMARY OF EVAL: THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE ATTRIBUTED TO THE USER DISASSEMBLING THE DEVICE. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO PRECLUDE USER DISASSEMBLY. THE SUBCOMPONENT IS NOW WELDED INSTEAD OF SCREWED. F1 TO F14: HAS BEEN COMPLETED BY THE MFR INFO HAS BEEN RECEIVED FROM A FOREIGN AFFILIATE. USER FACILITY INFO IS UNOBTAINABLE.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC OOPHERECTOMY. IT WAS REPORTED WHEN THE STAPLER WAS FIRED, THE STAPLES WERE MALFORMED. WHEN THE INSTRUMENT WAS FIRED THE STAPLER SOUNDED UNUSUAL. BLEEDING OCCURRED AT THE STAPLER LINE AND WAS CONTROLLED WITH BIPOLAR. THERE WAS NO CONSEQUENCE TO THE PT. NO BUTTRESSING MATERIAL WAS USED.
A1,2,3,4; B6,7; D10 CONTACTED SURGEON, INFO NOT AVAILABLE. D5; H4, 6 INFO ANTICIPATED BUT NOT AVAILABLE AT THIS TIME. D6 INFO NOT AVAILABLE. BASED UPON INQUIRY INFO RECEIVED, THE VISUAL EXAM, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY PRODUCED "MALFORMED STAPLES" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
PUMP WAS PROGRAMMED TO INFUSE A 250 ML BOTTLE OF "IVACORE" AT 21 ML/HR. HOWEVER, THE INFUSION COMPLETED IN 3 HRS INSTEAD OF 10 HRS. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. NO ADD'L INFO WAS OBTAINED.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY: FLOW ACCURACY TESTING WAS PERFORMED ON BOTH CHANNELS AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION.
PT ON TPN THERAPY FOR PAST WEEK. REPORTED THAT INFUSION DID NOT "GO IN" ON 10/7/96. UPON INVESTIGATION IT WAS LEARNED THAT THE DUAL RESET WAS NOT COMPLETED. PT MISSED ONE CYCLE OF TPN.
SOME HEMOLYZED RBC'S WERE RETURNED TO A PLASMA DONOR. THE DONOR EXPERIENCED RED URINE WITHOUT REPORTS OF ANY FURTHER DISCOMFORT.
A POSITION INDICATING SWITCH IN THE VALVE FAILED INTERMITTENTLY. THE SWITCH INDICATED THE VALVE IN THE RETURN LINE WAS OPEN WHEN IT WAS CLOSED. THIS ALLOWED PUMP TO PUSH AND PUMP BLOOD INTO CONFINED SPACE AND CAUSE SOME RED CELL HEMOLYSIS. SOME HEMOLYZED BLOOD WAS FORCED PAST THE VALVE WHICH CAUSED FREE HEMOGLOBIN IN DONOR RESULTING IN RED URINE. THE DONOR WAS EXAMINED AND GIVEN 500 ML SALINE IV. THE DONOR RECOVERED WITHOUT ANY FURTHER EVENTS. THE CAUSE OF THE SWITCH FAILURE WAS DETERMINED TO BE RELATED TO A POOR CONTACT BETWEEN THE CONDUCTIVE ELEMENTS OF THE SWITCH. THE LOSS OF CONDUCTION WAS ATTRIBUTED TO ONE SPOT ON THE CONTACTS HAVING A BUILD UP OF NON-CONDUCTIVE PARTICULATE MATTER IN THIS 3 YR OLD SWITCH.
HOSPITAL PERSONNEL REPORT ERRATIC INJECTIONS. THE INJECTIONS WOULD SLOW DOWN AND SPEED UP. NO INJURY OCCURRED. MFR'S SERVICE WAS CALLED.
MFR'S SERVICE REP COMPLETED A COMPLETE CHECK OUT OF THE INJECTOR AND COULD NOT CONFIRM THE REPORTED CONDITION. THE FLOW MODULE WAS REMOVED AND REPLACED AS A PRECAUTION. THE DEVICE CONTINUES TO BE USED.
PUMP WAS RECEIVED AT THE SERVICE FACILITY WITH A NOTE THAT STATED THE PUMP WAS "NOT DISPENSING PROPER SOLUTION". A FAMILY MEMBER REPORTED THIS TO A NURSE. NO ADD'L SPECIFIC INFO WAS ABLE TO BE RECEIVED. THE QUANTITY OF SOLUTION INVOLVED WAS NOT REPORTED. NO PT INJURY OCCURRED.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY: FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION.
1. MM X 4 MM DRILL BIT BROKE OFF IN SKULL WHILE DRILLING HOLES FOR PLATE ON CRANIOTOMY. MAXILLO-FACIAL SET USED. APPROX 1MM OF THE END OF DRILL BIT LEFT IN SKULL BECASUE IT WAS UNRETRIEVABLE.
THE LEAD WAS EXPLANTED DUR TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
EVALUATION: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CLACIFIED PLAQUE DURING IABP.
THE FOLLOWING WAS REPORTED TO DATASCOPE ON 11/7/96: THE IAB WAS INSERTED INTO FEMALE PT WHO HAD JUST UNDERGONE CABG. NO DIFFICULTY WAS ENCOUNTERED INSERTING THE IAB. GOOD AUGMENTATION WAS NOTED. BLOOD WAS NOTED IN THE GAS LINE. IABP WAS DISCONTINUED ONE HOUR LATER AND SURGEON AND PERFUSIONIST WERE NOTIFIED. THE PT'S BLOOD PRESSURE AND VITAL SIGNS REMAINED STABLE POST IABP TERMINATION. THE FOLLOWING DAY, THE PT APPEARED STABLE. THE PT REMAINED INTUBATED AND VENTILATED. [EVENT COMPLICATIONS]: UNKNOWN-REPORTED 9/20/96; NONE FROM THE EVENT-RPT'D 11/7/96. [PT'S CURRENT STATUS]: STABLE - RPTD' 11/7/96.
SUTURE BROKE FOLLOWING ANASTOMOSIS OF AORTIC GRAFT TO ILIAC. A NEW SUTURE WAS GIVEN TO DR AND HE COMPLETED PROCEDURE. EXPIRATION DATE: 2001.
THE DR WAS UNABLE TO ADVANCE THE IAB INTO THE SHEATH. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE SAME SHEATH WITHOUT ANY PROBLEMS. EVENT COMPLICATIONS: UNKNOWN-RPT'D 9/19/96; NONE FROM THE EVENT-RPT'D 10/11/96. PT'S CURRENT STATUS: PT. EXPIRED ON 9/22/96.
EVALUATION: THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY FOLDED. BLOOD WAS NOTED ON THE EXTERIOR OF THE IAB AND WITHIN THE INNER LUMEN. THE SHEATH USED WITH THE IAB, IF ANY, WAS NOT RETURNED FOR EVALUATION. ANY KINKS NOTED IN THE INNER LUMEN OR CATHETER TUBING ARE NOTED BY A "/" ON THE ATTACHED ILLUSTRATION. THE CATHETER O.D. WAS MEASURED AND MEMBRANE APPEARED NORMAL UNDER ROOM LIGHT AND POLARIZED LIGHT. AS A TEST, A VACUUM WAS DRAWN ON THE FOLDED MEMBRANE USING A LABORATORY 60 CC. SYRINGE AND ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH A LABORATORY 10 FRENCH, 6 INCH SHEATH WITHOUT DIFFICULTY. PROBABLE CAUSE OF DIFFICULTY: NO DEFECT WAS FOUND IN THE BALLOON'S FOLDED MEMBRANE OR IN THE IAB CATHETER. IT WAS NOT POSSIBLE TO VERIFY THE RPT'D DIFFICULTY IN THE LAB. IN GENERAL, DIFFICULTY ADVANCING THE IAB OR SHEATH INTO THE PT OR THE IAB INTO THE SHEATH MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: THE USER MAY HAVE NOT DRAWN A SUFFICIENT VACUUM ON THE BALLOON DURING ITS REMOVAL FROM THE BLISTER TRAY. IF DRAWN, A VACUUM MAY HAVE NOT BEEN MAINTAINED THROUGHOUT THE INSERTION PROCEDURE. DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. THE PT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO THE SHEATH. DURING IAB INSERTION, THE BALLOON TIP MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY AS IT EXITED THE END OF THE SHEATH.
BILATERAL TMJ DEGENERATIVE CHANGES SECONDARY TO BILATERAL TEFLON TMJ IMPLANTS. SEVERE TEMPOROMANDIBULAR JOINT DEGENERATIVE DISEASE WITH FOREIGN BODY (IMPLANT) AND FOREIGN BODY REACTION. 8/19/91 - ANTERIOR TYMPANIC MEMBRANE PERFORATION DUE TO IMPLANTS. 7/29/92 - MICROGENIA SECONDARY TO RIGHT AND LEFT TMJ CONDYLAR DEGENERATION FROM IMPLANTS.
A FOREIGN MATERIAL WAS NOTED INSIDE THE SAFETY CHAMBER. EVENT COMPLICATIONS: UNKNOWN-REPORTED 9/19/96. PT'S CURRENT STATUS: UNK-RPT'D 9/19/96.
DEVICE LABEL CODES: 1701. A DATASCOPE SAFETY CHAMBER, WAS RECEIVED FOR EVALUATION. IT WAS REPORTED THAT THE SAFETY CHAMBER WAS INSTALLED ON 4/29/96. VISUAL EXAMINATION REVEALED A FOREIGN BODY WITHIN THE INTERIOR OF THE CHAMBER. EXAMINATION OF FOREIGN BODY REVEALED TO BE A .25" OF WOOD FROM A COTTON APPLICATOR STICK. PROBABLE CAUSE OF DIFFICULTY: LABORATORY EXAMINATION VERIFIED THE REPORTED PROBLEM. IT IS NOT POSSIBLE TO DETERMINE EXACTLY WHEN THE FOREIGN BODY WAS INTRODUCED INTO THE SAFETY CHAMBER. SINCE THE SAFETY CHAMBER WAS IN USE APPROX. 5 MONTHS BEFORE THE FOREIGN BODY WAS NOTED AND IT WAS NOT OBSERVED WITHIN THE CHAMBER WHEN IT WAS INITIALLY INSTALLED, IT IS POSSIBLE THAT THE FOREIGN BODY WAS INTRODUCED WHEN THE CHAMBER OR PUMP COMPONENTS (TUBING, ETC.) WERE CLEANED OR SERVICED.
INTRACAPSULAR RUPTURE OF RIGHT SILICONE-GEL IMPLANT.
A CORONARY STENT WITH DELIVERY SYSTEM WAS ADVANCED TO THE PRE-DILATED TARGET LESION SITE IN THE PT'S SAPHENOUS VEIN GRAFT TO THE RIGHT MARGINAL BRANCH. UPON THE INITIAL INFLATION ATTEMPT, THE BALLOON RUPTURED LEAVING THE STENT UNDEPLOYED. THE DELIVERY SYSTEM WAS WITHDRAWN AND THE STENT WAS LOST IN EITHER THE CORONARY ARTERY OR THE PERIPHERAL CIRCULATION. A BALLOON ANGIOPLASTY WAS THEN PERFORMED. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE PS1540 BALLOON - EXPANDABLE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN NATIVE CORONARY PROCEDURES, ONLY. ADDITIONALLY THE SAFETY AND EFFICACY OF THE STENT HAS NOT BEEN ESTABLISHED IN PTS WITHIN 7 DAYS OF AN ACUTE MYOCARDIAL INFARCTION.
PUMP WAS RECEIVED AT CO'S SERVICE FACILITY WITH A VAGUE REPORT THAT IT INFUSED TIMES THE AMOUNT THAT WAS PROGRAMMED. THE NOTE STATED IT WAS "SET AT 100 ML/HR, INFUSED 200 ML/HR." NO ADD'L INFO HAS BEEN RECEIVED. NO PT INJURY WAS REPORTED.
OR AXLE. DEALER CLAIMS BALL BEARING FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRAC SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER AND THE IAB WAS REMOVED. A SECOND WAS INSERTED INTO THE PT AND THERAPY CONTINUED. NO ALARMS SOUNDED FROM THE PUMP. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 9/18/96 AND 10/11/96. PT'S CURRENT STATUS: STABLE-IN ICU-RPT'D 10/11.
DURING AN ATTEMPT TO ADVANCE A COROANRY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S LEFT ANTERIOR DESCENDING ARTRY, THE STENT DISLODGED OFF THE BALLOON CATHETER. THE DR USED THE BALLOON CATHETER TO DEPLOY THE STENT IN A LOCATION OTHER THAN THE INTENDED TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE DEVICE "WHEN INFLATED THE BALLOON BURST".
H6; CODE 400: INSTRUMENT WAS RECEIVED WITH THE BALLOON BURST AND ALL PIECES WERE RETURNED. THE POINT OF THE PROPAGATION COULD NOT BE DETERMINED.
ACCOUNT REPORTED THAT "A NURSE ATTEMPTING TO ENTER THE SITE HAD THE SEPTUM BURST OUT AND IN THE ENSUING MOVEMENT HAD BLOOD SPLASHED IN HER EYE. THIS BLOOD IS REPORTED TO BE HEPATITIS B POSITIVE." NO OTHER INFO AVAILABLE.
SECTION F COMPLETED BY CO. NO OTHER INFO IS AVAILABLE. EVAL SUMMARY: CO CONDUCTED A GROSS VISUAL EXAM OF ACTUAL DEVICE THROUGH BIOHAZARDOUS PACKAGING AND DISCOVERED A "POPPED...INVERTED" SEPTUM. FURTHER EVAL OF THE ACTUAL SAMPLE WAS NOT POSSIBLE DUE TO THE CONDITION OF THE SAMPLE, I.E. CONTAMINATED WITH HEPATITIS B POSITIVE BLOOD. SPECIFIC LOT IDENTITY WAS NOT KNOWN, HOWEVER, THE HOSP RETURNED ONE CASE OF LOT SI246264R AND PER MFG FACILITY, "PERFORMED A CANNULA INSERTION TEST" ON ALL CASE SAMPLES AND "NO SEPTUM INVERSIONS" WERE NOTED. IN ADDITION, LOT PRODUCTION RECORDS WERE REVIEWED AND "NO A COMPREHENSIVE REVIEW OF CO'S PRODUCT REPORTING DATABASE DID NOT REVEAL ANY SIMILAR REPORTS FOR THIS PRODUCT CODE AND LOT NUMBER, I.E. 2N3399-LOT SI246264R. HISTORICALLY SPEAKING, USER TECHNIQUE MAY BE A FACTOR AND MAY RESULT IN REPORTS OF SEPTUM DISPLACEMENT, I.E. INVERSION.
X-TUBE ASSEMBLY 19" X 16". DEALER CLAIMS X-TUBE BROKE AT THE BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DIES NOT REFLECT A CONCLUSION OR ADMISSION BY  QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBURTED TO THE REPORTABLE EVENT.
LABORATORY EXAMINATION OF THE RETURNED ITEM REVEALED NO DEFECT. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. TESTING FOR OCCULT BLOOD WITHIN THE BALLOON WAS NEGATIVE. PROBABLE CAUSE OF DIFFICULT: BASED ON THE EVENT DESCRIPTION AND PHYSICAL EVIDENCE, THERE WAS NO LEAK IN THE IAB. IT IS PROBABLE THAT DURING INSERTION BLOOD FLOWED BETWEEN THE FOLDS OF THE MEMBRANE AND EXITED NEAR THE CATHETER-MEMBRANE JUNCTION, LEADING TO THE PERCEPTION THAT THE BALLOON HAD LEAKED. DATASCOPE HAS INCORPORATED THIS CHANNELING PHENONOMEN IN ITS INSTRUCTIONS FOR USE FOR ALL STAT IABS.
PATIENT'S CURRENT STATUS: O.K. - RPT'D 10/18/96.
INFO ON A MEDICAL DEVICE REGISTRATION FORM INDICATED THAT DURING AN ATTEMPT TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S LEFT ANTERIOR DESCENDING ARTERY, THE STENT DISLODGED FROM THE DELIVERY SYSTEM WITHIN THE LEFT MAIN CORONARY ARTERY. THE STENT EMBOLIZED IN THE SUBCUTANEOUS TISSUE DURING RETRIEVAL ATTEMPTS WITH A MICROSNARE. THE SUBCUTANEOUS TISSUE WAS PROBED TO LOCATE THE STENT, AND A SUBSEQUENT FEMORAL HEMATOMA WAS EVACUATED. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE MEASURES-44MM AND HAS MIGRATED DOWN LEAD BODY-57MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE LENGTH OF THE J STIFFENER WIRE WAS RECEIVED WITH RECORDED MEASUREMENTS ADDING UP TO-88MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURE.
PREVIOUSLY REPORTED AS NO REPORT OF MALFUNCTION, SERIOUS INJURY, OR REASON FOR EXPLANT. THE LEAD WAS EXPLANTED DUE TO A REPORT OF POCKET INFECTION. EXPLANT METHOD: THORACOTOMY. NO COMPLICATIONS.
PER MEDWATCH FORM RECEIVED 10/7/96 FROM THE USER FACILITY: A 67-YR-OLD MALE FOUND PULSELESS AND APNEIC BY ENGINE CO. "WITNESSED CARDIAC ARREST BY WIFE", WHEN ENGINE CO ATTEMPTED TO REMOVE THE BACKING OF THE DEFIB PADS THEY WERE UNABLE TO DO SO. 2 TO 4 MINS LATER THE AMBULANCE WAS AT THE PT'S SIDE AND THE PT WAS IN A NONSHOCKABLE RHYTHM (PEA). AT NO POINT EVEN AFTER THE CALL COULD THE BACKING BE REMOVED. UNCONFIRMED BUT BELIEVED THE PT WAS PRONOUNCED DEAD AT HOSP. THE ELECTRODES PADS USED DURING THE REPORTED INCIDENT HAVE BEEN LOCATED, BUT HAVE NOT YET BEEN RETURNED TO CO. PER THE USER FACILITY, THIS IS A POSSIBLE DEATH.
THE HEALTH CARE PROFESSIONAL REPORTS THAT DURING A PHACO EMULSIFICATION PROCEDURE THE ASPIRATION FUNCTION DID NOT APPEAR TO BE FUNCTIONING AS EXPECTED. SURGERY WAS DELAYED FOR TEN MINUTES, ANOTHER PACK WAS SUBSTITUTED. THERE WAS NO EFFECT ON THE PT.
H.3. VISUAL INSPECTION DISCOVERED SCRATCHES ON THE CASSETTE AND THE CASSETTE APPEARED USED. THE CASSETTE WAS TESTED FOR FUNCTIONALITY UTILIZING A CO'S MICROSURGICAL SYSTEM. THE CASSETTE FUNCTIONED PROPERLY. NO DEFECTS WERE FOUND, CASSETTE MEETS SPECS. CO HAS NOTIFIED MICROSURGICAL SYSTEM MFR THAT THE PROBLEM MAY LIE WITH THE SURGICAL SYSTEM BEING USED.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS X-TUBE BROKE AT THE BOLT HOLE.
IN AN ATTEMPT TO DEPLOY A STENT INTO A SAPHANEOUS VEIN GRAFT, THE BALLON FAILED TO INFLATE PROPERLY RESULTING IN A PARTIALLY DEPLOYED STENT. CONTRAST WAS SEEN  FLOWING INTO THE DISTAL VESSEL DURING INFLATION, THE RESULT OF A LEAK IN THE BALLOON. ANOTHER BALLOON WAS USED, BUT IT WAS UNSUCCESSFUL AND THE PT WENT TO BY-PASS SURGERY.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OR THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR HE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRAC SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
9/3/96: ADM WITH NON-FUNCTIONING CAPD CATH. TO OR FOR RE-POSITION OF CATHETER. 9/5/96: PT DEVELOPED PERITONITIS SECONDARY TO NECROTIC BOWEL. RETURNED TO OR FOR EXP. LAP. WITH SMALL BOWEL RESECTION. 9/13/96: TO OR FOR DISRUPTION OF ANASTOMOSIS. OP NOTE STATES "SIDE TO SIDE ANASTOMOSIS THAT HAD BEEN PERFORMED WAS LEAKING THROUGH SUTURE LINE." PT HAD STORMY POST-OP COURSE AND EVENTUALLY EXPIRED 10/7/96.
THE DEVICE WAS TESTED BY HOSP PERSONNEL PRIOR TO INSERTION AND DID NOT RETRACT. CO ENGINEER DETERMINED THIS EXTREMELY RARE FAILURE TO BE CAUSED BY THE DEFECTIVE SPRING KEEPER. EFFECTIVE 9/10/96 THERE HAS ALREADY BEEN A CHANGE TO THE PROCESS AT ORIGIN THAT WILL MAKE THE SPRING-KEEPER EVEN MORE RELIABLE. THE DEVICE WAS MFG 11/20/95, PRIOR TO THE PROCESS CHANGE.
CUSTOMER HAS CLAIMED THAT THE TIP DID NOT RETRACT IN THE RETURNED UNIT. THE UNIT PRODUCT DUPLICATED FOR THE FAILURE. UPON DISASSEMBLING THE UNIT THE RED SPRING KEEPER WAS FOUND BROKEN. THE CAUSE OF THE FAILURE IS DUE TO THE FAILURE OF THE SPRING KEEPER. IT IS AN EXTREMELY RARE FAILURE. MPI 3245 IS MODIFIED TO PROVIDE A PROPER ORIENTATION OF THE FLEX SHAFT CRIMP WITH RESPECT TO SPRING KEEPER SLOT. FLEX SHAFT CRIMP SHOULD BE SYMMETRICAL TO THE SPRING KEEPER SLOT BEFORE FLEX SHAFT IS PUSHED TO THE KEEPER POSITION ELIMINATING THE WEDGING STRESS ON THE SLOT. THIS CHANGE WAS MADE THROUGH ECO 2897 AND IS EFFECTIVE SINCE 9/10/96.
DURING A PHACO EMULSIFICATION PROCEDURE THE ASPIRATION FUNCTION DID NOT APPEAR TO BE FUNCTIONING AS EXPECTED. SURGERY WAS DELAYED FOR TEN MINUTES, ANOTHER PACK WAS SUBSTITUTED. THERE WAS NO EFFECT ON THE PT.
H.3. VISUAL INSPECTION DISCOVERED SCRATCHES ON THE CASSETTE AND THE CASSETTE APPEARED USED. THE CASSETTE WAS TESTED FOR FUNCTIONALITY UTILIZING CO'S SYSTEM. THE CASSETTE FUNCTIONED PROPERLY. NO DEFECTS WERE FOUND, CASSETTE MEETS SPECS. CO INC. HAS NOTIFIED MFR THAT THE PROBLEM MAY LIE WITH THE SURGICAL SYSTEM BEING USED.
ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE PRE-DILATED TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY WERE UNSUCCESSFUL. DURING WITHDRAWAL OF THE DELIVERY SYSTEM, THE SHEATH RETRACTED AND THE STENT EMBOLIZED. THE DR THEN COMPRESSED THE STENT AGAINST THE VESSEL WALL. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
A PT THAT WAS INTUBATED WENT INTO RESPIRATORY FAILURE. A CODE WAS CALLED AND IT WAS NOTED THAT THE PILOT LINE HAD SEPARATED. UNABLE TO VENTILATE PT, SO PT EXTUBATED. DIFFICULTY WAS EXPERIENCED DURING RE-TUBATION, LEADING TO A BRONCHOSCOPE REQUIRED FOR RE-TUBATION. STATUS OF PT UNKNOWN. ANOTHER INCIDENT OF PILOT LINE SEPARATION ALSO OCCURRED, HOWEVER, THERE WAS NO PT COMPROMISE.
SECTION F COMPLETED BY CO. NO OTHER INFO IS AVAILABLE. EVAL: SAMPLE 1) TUBE APPEARED TO BE BENT/DISTORTED AT THE 25TH GRADUATION MARK. INFLATION LUMEN IN THE TRACHEAL TUBE APPROX 7MM AWAY FROM THE PILOT ASSEMBLY NOTCH IN THE TRACHEAL TUBE WAS NOTED TO BE COVERED WITH GLUE. SLIGHT TRACES OF PVC GLUE WAS ALSO OBSERVED IN THE INFLATION LUMEN WHEN THE EXPANDED AREA WAS CUT OPEN AND EXAMINED. SAMPLE 2) THE INFLATION LUMEN IN THE TRACHEAL TUBE APPROX 9MM AWAY FROM THE PILOT ASSEMBLY NOTCH IN THE TRACHEAL TUBE WAS NOTED TO BE COVERED WITH GLUE. SLIGHT TRACES OF PVC GLUE WAS ALSO NOTED IN THE INFLATION LUMEN WHEN THE EXPANDED AREA WAS CUT. COMPLAINT WAS CONFIRMED PER RETURNED SAMPLES. IT IS UNLIKELY THAT SUCH DAMAGE TO THE PRODUCT COULD HAVE PASSED THE STRINGENT INFLATION TEST AND INSPECTION. IT IS POSSIBLE THIS TYPE OF DISCONNECTION COULD HAVE OCCURRED DURING USAGE AT THE CUSTOMER END AS EVIDENCE OF TAPING MATERIAL AND TUBE DISTORTION (BENT) WERE OBSERVED.
X-TUBE ASSEMBLY 20" X 18". DEALER CLAIMS X-TUBE BROK AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THA THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE.
HIGH STRESS FACTOR AT THE CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLRECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REPORT REC'D  OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
CONTROL BOX MAIN PG8/50 P1. DEALER CLAIMS CHAIR WANTS TO OPERATE ON ITS OWN.
WATER DAMAGE TO THE PC BOARD FOUND. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CRF PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PLACED 24G MIDLINE CATHETER TO R AC VEIN; INSERTED 6 INCHES. AFTER COMPLETION PT BECAME FLUSHED AND MILD SHORTNESS OF BREATH, WHICH RESOLVED AFTER 20 MINS. 45 MINS AFTER INSERTION PT HAD SHAKING, CHILLS, TEMPERATURE OF 48 DEGREES THEN SPIKED TO 101.5 DEGREES. REMOVED CATHETER, SYMPTOMS RESOLVED AFTER 20 MINS. PT BACK TO BASELINE.
REPORT REC'D OF SUSPECTED J RETENTION J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
DURING USE OF AN INFUSION PUMP, TWO NURSES SELECTED ML INSTEAD OF MG. INSTEAD OF SETTING UP A PT DOSE OF 0.5 MG, THEY SET UP 0.5 ML, THUS A BOLUS OF 4ML WAS GIVEN INSTEAD OF 4MG. BOTH NURSES NOTICED A PROBLEM BECAUSE IT TOOK SO LONG FOR THE BOLUS TO BE ADMINISTERED. THE PROBLEM COULD HAVE ALSO BEEN PREVENTED IF THE MFR DID NOT ALLOW A CHOICE BETWEEN ML AND MG. IT WOULD BE BEST IF THE ML IS LOCKED.
REAR S/F DAB. DEALER CLAIMS FRAME IS BROKEN AT THE SECOND VERTICAL TUBE NEAR THE WELD.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CRF PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE LEAD WAS EXPLANTED DUE TO A RPT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. EXPLANT METHOD: INTRAVASCULAR. TECHNIQUE/TOOLS: INTRAVASCULAR COUNTER TRACTION. NO COMPLICATIONS.
WHILE RPTR HAD BEEN WORKING IN LABOR AND DELIVERY, SHE DEVELOPED HIVES AND A RASH ON HER HANDS. SHE CHANGED GLOVES AND HER SKIN PROBLEMS STOPPED. NEVERTHELESS, IN THE LAST 6-8 MONTHS SHE DEVELOPED ASTHMA. DURING THIS PERIOD OF TIME SHE WAS USING LATEX GLOVES. MD PRESCRIBED SOME MEDICATIONS DUE TO HER ALLERGIC REACTIONS. RPTR WAS TAKING ALL MEDICATIONS AND STARTED TO USE NON-LATEX GLOVES. ONE DAY, WHILE TAKING CARE OF A PT, SHE DEVELOPED RUNNY NOSE, SHORTNESS OF BREATH, WATERY EYES AND WHEEZING. AN INHALER WAS PROVIDED AND AN EXTRA DOSE OF ANTIHISTAMINE WAS ADMINISTERED. AT THIS TIME PT WAS USING NON LATEX GLOVES AND NON-LATEX MASK. SHE LATER DEVELOPED ANOTHER REACTION. ALTHOUGH PT SWITCHED TO A NON-LATEX GLOVE, EACH TIME SHE CAME IN CONTACT WITH SOMEONE THAT WAS USING A LATEX PRODUCT SHE GOT AN ALLERGIC REACTION. SHE IS NO LONGER WORKING AS AN RN.
THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING. EVENT COMPLICATIONS: UNKNOWN - REPORTED 9/19/96. PT'S CURRENT STATUS:UNK - RPT'D 9/19/96.
CASTER HINGE L. DEALER CLAIMS CASTER HINGE FELL OFF.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CRF PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REPORT FROM DISTRIBUTOR INDICATED THAT USER ENCOUNTERED DIFFICULTY IN REMOVING PROTECTIVE LINER. PADS PULLED APART WHEN USER WAS UNABLE TO REMOVE LINER.
THE HOME RESPIRATORY CARE DEPT, ROUTINELY DISCHARGES PTS TO HOMES USING SEVERAL UNRELATED PIECES OF HOME MEDICAL EQUIPMENT. TWO OF THE MORE COMMONLY USED MACHINES IN THE SAME HOMECARE ENVIRONMENT ARE THE PORTABLE SUCTION MACHINE AND THE APNEA/HEARTRATE MONITORS. THESE TWO UNIQUE DIFFERENT DEVICES, UNFORTUNATELY, BOTH USE A DC CHARGING UNIT WITH AN IDENTICAL OUTPUT ADAPTER. DESPITE THEIR SIMILAR APPEARANCE THE CHARGERS' OUTPUT CURRENTS ARE DIFFERENT (180 MA VS 1.8 A) AND WHEN THE CHARGER IS MISTAKENLY INSERTED INTO THE MONITOR IT CAUSES EXTENSIVE HEAT-RELATED DAMAGE TO THE UNIT. TYPICAL DAMAGE INVOLVES INTERNAL BATTERIES, CIRCUIT BOARDS AND CABINET PANELS. OF GREATER IMPORTANCE IS THE FACT THAT THE MELTING BATTERIES AND PLASTIC PANELS OF THE MONITOR COULD CONCEIVABLY CREATE A LIFE-THREATENING, FIRE-RELATED SITUATION. RPTR RELATES THREE INCIDENTS WITHIN THE PAST EIGHTEEN MONTHS. WHEN NOTIFIED OF THESE OCCURRENCES THE MFR'S REP AND THE CO'S REG MGR ADDRESSED SITUATION AS ISOLATED AND UNUSUAL AND IDENTIFIED THEM AS "TRAINING ISSUES." THEY DECLINED A REQUEST TO PERMANENTLY HARDWIRE THE CHARGER TO THE MONITOR, BUT DID AUTHORIZE THE USE OF SHRINK TUBING TO SEMI-PERMANENTLY ATTACH THE TWO COMPONENTS. ALSO, COLOR-CODED BANDS WERE USED AS A MEANS OF IDENTIFICATION. THESE ARE ONLY STOP-GAP MEASURES AT BEST, AND A POTENTIAL FOR CATASTROPHIC EVENT CONTINUES TO EXISTS.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REPORT STATED, THE PLASTIC HANDLE ON THE T-HANDLE WITH 1/4 HEX DRIVE CRACKED DURING CLEANING AND STERILIZATION PROCESS POST OPERATIVELY. THIS EVENT DID NOT OCCUR DURING THE SURGICAL PROCEDURE. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVAL: FATIGUE OF POLYMER DUE TO BUILD UP OF INTERNAL STRESSES COUPLED WITH THERMAL STRESSES DURING AUTOCLAVING. SECTION F1-14: HAS BEEN COMPLETED BY THE MFR. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
ON 9/3/96, THE DR TRIED TO INSERT A SHEATHLESS IAB VIA THE FEMORAL ARTERY. THE PT HAD CALCIFICATION IN THE AORTA SO THE IAB WAS INSERTED TRANSTHORACICALLY. AFTER IABP FOR 12 HRS, THE IAB LEAKED. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORT 9/17/96. PT'S CURRENT STATUS: WELL, OK -9/17/96.
THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 4/25/97. DEVICE LABEL CODE FOR F10. POSITION 1: 1738. EVALUATION SUMMARY: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE INNER LUMEN. UNDER MICROSCOPY, A SEPARATION OF THE INNER LUMEN WAS SEEN. THE ROUGH EDGED POINTS OF SEPARATION WERE IRREGULAR IN CONTOUR SUGGESTING THAT THE INNER LUMEN BROKE. THE BROKEN PORTION OF THE INNER LUMEN HAD A WHITISH APPEARANCE, INDICATING A POINT OF STRESS. PROBABLE CAUSE OF DIFFICULTY: THE IAB LEAK WAS THE RESULT OF A BREAK OF THE INNER LUMEN. IT IS POSSIBLE THAT THE IAB WAS RESTRAINED WITHIN THE AORTA DURING IABP. THIS WOULD HAVE RESULTED IN A CYCLICAL STRESS TO THE INNER LUMEN AND, ULTIMATELY, A SEPARATION AT THE POINT OF STRESS. THE IAB MAY HAVE BEEN RESTRAINED AS A RESULT OF PLACEMENT WITHIN A SUBINTIMAL SPACE, WITHIN THE SUBCLAVIAN ARTERY, OR UNDERNEATH PLAQUE. IT IS ALSO POSSIBLE THAT THE INITIAL KINK IN THE INNER LUMEN WAS MADE DURING IAB INSERTION AND THAT IABP CONTINUED TO CYCLICALLY STRESS THE TIP/INNER LUMEN JUNCTION.
WHEN RUNNING ON BATTERY POWER, THE BATTERY ICON ON THE FRONT PANEL WILL FLASH "LOW" WHEN THE FIRST BATTERY IS DEPLETED. HOWEVER, RATHER THAN SWITCH FROM BATTERY #1 TO BATTERY #2, THE DEVICE WILL SHUTOFF. NO PT IMPACT.
DATE OF THIS REPORT: 10/16/96. EVENT CODE-2199-NA. ALL SECTIONS ON THIS FORM COMPLETED BY MFR. CUSTOMER REPORTS THAT WHEN ONE OF THE BATTERIES BECOMES DEPLETED, THE MONITOR SHUTS OFF INSTEAD OF SWITCHING TO THE SECONDARY BATTERY. THE UNIT WAS RETURNED TO THE CO'S SERVICE CTR FOR EVAL. A REVIEW OF THE ERROR LOG SHOWED 2 EVENTS OF AN S01 ALARM. THIS IS A SYSTEM CLOCK ERROR AND IS NOT RELATED TO THE MONITOR'S ABILITY TO SWITCH FROM ONE BATTERY TO ANOTHER. THE UNIT WAS THEN TESTED USING THE CUSTOMER'S BATTERIES AND PRINTER MODULE. AFTER BATTERY 1 BECAME DEPLETED THE UNIT WOULD NOT SWITCH TO BATTERY 2. INSTEAD THE MONITOR RESET AND ATTEMPTED TO POWER UP. AFTER SEVERAL ATTEMPTS TO POWER UP, THE UNIT GAVE AN S01 ALARM. BY FAULT ISOLATION IT WAS FOUND THAT A FAILURE OF U21 ON THE PROCESSOR BOARD WAS CAUSING THE S01 ALARM. FURTHER FAULT ISOLATION FOUND A FAILURE OF Q1 ON THE BATTERY SWITCH BOARD WAS CAUSING THE INABILITY TO SWITCH BATTERIES. ONCE THESE COMPONENTS WERE REPLACED THE MONITOR OPERATED PROPERLY. THE CUSTOMER'S REPORT OF THE UNIT NOT SWITCHING BATTERIES WAS VERIFIED. THE CAUSE WAS FOUND TO BE THE FAILURE OF TRANSISTOR Q1 ON THE BATTERY SWITCH BOARD. THIS IS CONSIDERED A RANDOM COMPONENT FAILURE AS NO PRODUCT RELATED DESIGN ISSUES WERE IDENTIFIED. STATISTICAL PROCESS CONTROL (SPC) DATA WILL BE REVIEWED REGULARLY TO DETERMINE IF SIGNIFICANT TRENDS ARE IDENTIFIED RELATED TO THIS REPORT. IF SIGNIFICANT TRENDS ARE IDENTIFIED, A SEPARATE INVESTIGATION WILL BE INITIATED.
A FACILITY REPORTED THAT A MACHINE DID NOT ALARM AS EXPECTED WHEN A DIALYZER BLOOD LEAK OCCURRED. APPROX. 1 HR AND 10 MINUTES INTO THE TREATMENT, THE PT BECAME HYPOTENSIVE AND EXPERIENCED NAUSEA AND VOMITING. THIRTY MINUTES LATER BLOOD WAS VISIBLE IN THE EFFLUENT DIALYSATE LINE. THR MACHINE DID NOT ALARM. THE TREATMENT WAS STOPPED AND THE PT'S BLOOD WAS NOT RETURNED. ESTIMATED BLOOD LOSS, 350ML. THE PT WAS HYPOTENSIVE, 68/42, AND TRANSPORTED TO THE HOSP. THE MACHINE WAS REMOVED FROM THE TREATMENT AREA FOR INVESTIGATION BY THE MFR. THE INVESTIGATION FOUND A PROBLEM WITH THE VOLTAGE FROM THE BLOOD LEAK DETECTOR SENSOR. THE MACHINE WAS REPAIRED AND PROPER OPERATION VERIFIED.
H6. THE INVESTIGATION SHOWED THAT IF THE PRETREATMENT MACHINE ALARM TESTING DESCRIBED IN THE DEVICE LABELING, HAD BEEN PERFORMED, THE MACHINE WOULD HAVE FAILED. ALERTING THE OPERATOR OF A MACHINE PROBLEM.
REPORTER STATED, THE METAL ON THE REAMER CHIPPED OR FRAGMENTED OFF AFTER A FEW USES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME DUE TO THIS EVENT.
SUMMARY OF EVAL: THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO THE USER USING THE DEVICE ON A MATERIAL OTHER THAN BONE OR USING WITH SOME SORT OF GUIDE WHICH IS NOT RECOMMENDED. THE AGENT TO INSTRUCT THE USERS ON PROPER USE OF THE REAMER. SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FORM THE USER FACILITY AND IS UNOBTAINABLE.
QR AXLE. DEALER CLAIMS AXLES ARE DEFECTIVE. THE QUICK RELEASE BALLS ARE NOT MOVING UP OR OUT IN THE AXLE SHAFT TO ALLOW THE WHEELS TO STAY ON THE CHAIR.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CRF PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INITIALLY, THE DR HAD DIFFICULTY INFLATING THE IAB USING A SYRINGE WITH A 30 CC. THE IAB WAS USED WITHOUT ANY PROBLEM. EVENT COMPLICATIONS: UNKNOWN - REPORTED 9/17/96. PT'S CURRENT STATUS: UNK RPT 'D 9/17/96.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE BALLOON WAS SUCCESSFULLY USED.
BLOOD WAS NOTICED IN THE CATHETER TUBING AFTER AN UNDETERMINED AMOUNT OF TIME. PT SUFFERED NO COMPLICATION. FURTHER INFO NOT AVAILABLE FROM THE CUSTOMER.
H11-ALL UNK INFO REQUESTED BUT NOT RECEIVED. H11-SECTION F PROVIDED BY MFR. H11-SECTION F10 DEVICE CODE 1746 LABEL.
A PT HAD LOST AN EXCESS OF 1.6 KG OF FLUID OVER WHAT THE MACHINE WAS PROGRAMMED TO REMOVE. THE FACILITY STATES THE MACHINE PASSED RECOMMENDED TESTING PRIOR TO INITIATION OF THE TREATMENT. THE TMP LIMITS WERE SET AT +/-50MMHG AROUND THE INITIAL TMP OF 160MMHG. THE PT WAS DIALYZING ON A REUSED HIGH FLUX DIALYZER. MFR LABELING RECOMMENDS THE TMP ALARM LIMITS ARE SET AT +/-20MMHG FOR HIGH FLUX DIALYZERS. THE FACILITY STATES THAT NO UNUSUAL ALARMS OCCURRED, BUT THE TMP DID FLUCTUATE AS HIGH AS 200MMHG DURING THE TREATMENT. THE PT BECAME HYPOTENSIVE AND RESPONDED TO 500ML OF NORMAL SALINE, COMPLETING THE TREATMENT. AN ADD'L 800ML OF NS WAS GIVEN AFTER THE TREATMENT WAS DISCONTINUED. THE MACHINE WAS SERVICED BY THE FACILITY MACHINE TECH, WHO TOLD THE MFR THAT AN ON SITE MACHINE INSPECTION WAS NOT NECESSARY BECAUSE THE MACHINE WAS OPERATING PROPERLY NOW.
FACILITY MACHINE TECHNICIAN STATED HE RECALIBRATED A CIRCUIT BOARD.
REAR S/F DAB. DEALER CLAIMS FRAME BROKE WHERE BACK PLATE ATTACHES TO THE FRAME.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT FIRMS, OR THEIR EMPLOYESS CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS APPLIED DURING AN ESOPHAGECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
10/17/96 MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
INITIALLY THE DR HAD DIFFICULTY INFLATING THE IAB USING A SYRINGE WITH A 40 CC VACUUM. THE IAB WAS USED WITHOUT ANY PROBLEM. EVENT COMPLICATIONS: UNKNOWN-REPORT 9/17/96. PT'S CURRENT STATUS: UNKNOWN-RPT'D 9/17/96.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. SINCE THE PRODUCT INVOLVED IN THIS EVENT WAS NOT RETURNED TO CO FOR EVAL, THE FILE WILL BE CLOSED. THE DEVICE WAS SUCCESSFULLY USED ON THE PT AND WILL NOT BE RETURNED.
QR AXLE. DEALER CLAIMS BALL BEARINGS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE PRODUCT WAS APPLIED DURING AN UNSPECIFIED ORTHOPEDIC PROCEDURE. REPORTEDLY, THE SUTURE BROKE.
THE CUSTOMER REPORTED ERRATIC BLOOD GLUCOSE READINGS WITH TEST STRIPS. ON 9/3/96, THE CUSTOMER OPENED THE FIRST BOTTLE FROM A BOX OF FIFTY. THE FIRST THREE READINGS WERE 24,27 AND 21 MG/DL. THE FOURTH READING WAS 184 MG/DL. ALL TEST WERE PERFORMED WITHIN A 15 TO 20 MINUTE TIME SPAN. THE CUSTOMER STATED THAT HE OBTAINED LOW READINGS IN THE 20 MG/DL RANGE WITH APPROX. THREE OF EVERY FOUR TEST STRIPS. HE HAS USED ALL OF THE STRIPS FROM THE FIRST BOTTLE AND APPROX HALF OF THOSE FROM THE SECOND BOTTLE. THE CUSTOMER PERFORMED A CHECK STRIP TEST WITH THE CO REPRESENTATIVE. THE RESULT WAS 88 VERSUS A RANGE OF 77-98. BECAUSE THE CUSTOMER DID NOT HAVE NORMAL CONTROL SOLUTION, A NORMAL CONTROL SOLUTION TEST WAS NOT PERFORMED WITH THE REPRESENTATIVE. THE DESICCANT WAS PRESENT IN THE FIRST BOTTLE AND IS PRESENT IN THE OPEN BOTTLE. THE CUSTOMER STORES HIS TEST STRIPS IN THE BEDROOM.
THE RETENTION SAMPLE TEST RESULTS MEET THE SPECIFICATIONS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND WERE NOT ERRATIC IN NATURE. THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. CUSTOMER DID NOT PERFORM NORMAL CONTROL SOLUTION TEST TO CHECK THE STRIPS FOR ACCURACY. CUSTOMER STATED THAT HE OPENED THE FIRST BOTTLE FROM A DISPLAY BOX OF FIFTY STRIPS AND OBTAINED READINGS OF 24,27,21 AND 184 MG/DL. CUSTOMER HAS USED ALL OF THE TEST STRIPS FROM THE FIRST BOTTLE AND APPROX HALF OF THOSE FROM THE SECOND BOTTLE. BASED ON THE EVALUATION OF RETENTION SAMPLES, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. CO REQUESTED THAT THE PRODUCT BE RETURNED FOR EVALUATION ON 9/20/96. AS OF 10/18/96, RETURNED PRODUCT HAS NOT BEEN RECEIVED. CO WILL FORWARD A FOLLOW-UP TO THIS REPORT UPON RECEIPT OF RETURNED TEST STRIPS AND THEIR EVALUATION. TIME FRAME IS UNKNOWN. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NOT STATED, IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FORE DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
THE IAB WOULD NOT INFLATE EVEN AFTER MANUAL INFLATION. (EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 9/17/96). (PT'S STATUS: UNK-RPT'D 9/17/96.
DEVICE LABEL CODES: 1738. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE BALLOON MEMBRANE NOTED TO BE UNFOLDED. VISUAL EXAMINATION REVEALED THAT THE SHEATH WAS COVERING A PORTION OF THE MEMBRANE NEAR THE CATHETER/ MEMBRANE JUNCTION. THE SHEATH WAS OBSERVED TO BE SEVERELY KINKED AND DAMAGED. AFTER THE SHEATH WAS PULLED BACK PAST THE METAL SLEEVE, VISUAL EXAMINATION REVEALED THE MEMBRANE AT THE PROXIMAL TAPER TO BE STRETCHED. WHEN THIS AREA WAS VIEWED UNDER POLARIZED LIGHT, THE AREA APPEARED STRESSED. AS A TEST, THE IAB WAS PLACED IN A TEST CHAMBER HAVING A 75 MMHG BACK PRESSURE TO SIMULATE THE PRESSURE WITHIN THE AORTA. IT WAS NOT POSSIBLE TO PUMP THE BALLOON SATISFACTORILY AT 80 AND 160 BPM ON THE LABORATORY SYSTEM 90 IABP DUE TO THE CONDITION OF THE MEMBRANE. PROBABLY CAUSE OF DIFFICULTY: IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED INFLATION DIFFICULTY BASED ON THE EVENT DESCRIPTION AND THE EXAMINATION OF THE ITEM. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED PROBLEM. THIS TYPE OF COMPLAI0T IS ONE OF THE MOST DIFFICULT TO EVALUATE AND MUST RELY ON CONJECTURE SINCE ONE CANNOT OBSERVE WHAT THE BALLOON IS BEING SUBJECTED TO WITHIN THE AORTA. THUS, IN GENERAL INFLATION DIFFICULTIES MAY ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: 1. THE MEMBRANE DID NOT FULLY EXIT THE SHEATH (THE CONDITION OF THE RETURNED IAB SUPPORTS THIS STATEMENT). 2. THE BALLOON ENTERED A SUBINTIMAL SPACE. 3. THE BALLOON WAS PLACED TO HIGH IN THE AORTIC ARCH OR IN THE SUBCLAVIAN ARTERY. 4. THE IAB FAILED TO COMPLETELY UNFOLD BECAUSE THE USER FAILED TO INJECT AT LEAST 30 CC. OF AIR AS ADVISED IN THE INSTRUCTIONS FOR USE. 5. THE CATHETER KINKED WITHIN THE PT PROBABLY BECAUSE OF SEVERE VESSEL TORTUOSITY AND/OR PT MOVEMENT. 6. THE CATHETER KINKED OUTSIDE THE PT. THE USER MAY HAVE FAILED TO SECURE THE CATHETER AND Y-FITTING TO THE PT. MANIPULATION OF THE KINKED PORTION OF THE CATHETER COULD HAVE MINIMIZED THE RESTRICTION AND IMPROVE BALLOON PERFORMANCE. 7. A KINK IN THE CATHETER MAY HAVE RESTRICTED THE FLOW OF HELIUM INTO AND OUT OF THE BALLOON CAUSING IT TO NOT FULLY INFLATE DURING THE INITIATION OF IABP. 8. THERE WAS A LOOSE CONNECTION BETWEEN THE IAB AND THE PUMP OR BETWEEN THE PUMP AND THE SAFETY CHAMBER. CHECKING THESE CONNECTIONS MAY ALLEVIATE THE PROBLEM. 9. THE BALLOON PUMP NEEDED SERVICING.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS X-TUBE BROKE AT CENTER BOLT.
10/17/96-MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
FIVE SAMPLES WERE RETURNED FOR INVESTIGATION. THE INVESTIGATUON REVEALED THAT EACH SET HAD SEPARATED AT THE AIR IN LINE ADAPTER/SILICON TUBING ENGAGEMENT. THE SEGMENT OF EACH SET WAS RECONNECTED AND TESTED. THE JUNCTION OF ALL 5 SETS HELD WITHIN PRODUCT SPECIFICATION. THIS JUNCTION IS A FRICTION FIT ENGAGEMENT AND IS NOT BONDED. IT IS UNKNOWN THAT EXCESS PRESSURE OR PULLING FORCES, AS EXHIBITED DURING IV PUSH WILL RESULT IN SET SEPARATION. IT IS RECOMMENDED THAT THE TUBING BETWEEN THE PUSH SITE AND THE PUMP SEGMENT BE CLAMPED TO PREVENT PRESSURE FROM REACHING THE PUMP SEGMENT, OR SEPARATION MAY OCCUR. DS EXPIRATION DATE IS 5 YRS FROM MFG. DATE. NO SERIAL NUMBER FOR THIS PRODUCT, SHOULD BE NA. D10 UNK, F13 MEDWATCH REPORT RECVD 9/11/96 FROM USER FACILITY.
A COMPLAINT WAS RECEIVED FROM A CUSTOMER WHO HAS EXPERIENCED BOUTS OF HYPOGLYCEMIA (NO SPECIFIC RESULTS). HE WAS ADMITTED TO A HOSPITAL WITH A "HYPO" (ASSUME HE MEANT HYPOGLYCEMIA). HE HAD KEELED OVER. HIS BLOOD GLUCOSE READINGS HAVE BEEN ERRATIC OVER THE LAST FEW DAY BETWEEN 26.0 MMOL/L AND 1.1 MMOL/L (468 MG/DL 20 MG/DL RESPECTIVELY). IN ADDITION, THE PLASTIC COVERING THE OPTIC WINDOW IS MISSING AND THEREFORE CAUSED THE INCORRECT READINGS. IN REVIEW OF THE OPERATION OF THE CHECK PADDLES RESULTS WERE HIGH AND OUTSIDE OF SPECIFICATION. A REQUEST WAS MADE TO RETURN THE METER FOR EVAL.
THE INSTRUMENT WAS RETURNED FOR EVAL. PERFORMANCE TESTING DID NOT CONFIRM LOWER RESULTS CAUSED BY A MISSING PLASTIC COVER OVER THE OPTICAL WINDOW. THE COMPLAINT IS CONSIDERED CLOSED.
DEVICE LABEL CODES: 1738. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE INNER LUMEN. UNDER MICROSCOPY, A SEPARATION OF THE INNER LUMEN WAS SEEN. THE ROUGH EDGED POINTS OF SEPARATION WERE IRREGULAR IN CONTOUR SUGGESTING THAT THE INNER LUMEN BROKE. THE BROKEN PORTION OF THE INNER LUMEN HAD A WHITISH APPEARANCE, INDICATING A POINT OF STRESS. PROBABLE CAUSE OF DIFFICULTY: THE IAB LEAK WAS THE RESULT OF A BREAK OF THE INNER LUMEN. IT IS POSSIBLE THAT THE IAB WAS RESTRAINED WITHIN THE AORTA DURING IABP. THIS WOULD HAVE RESULTED IN A CYCLICAL STRESS. THE IAB MAY HAVE BEEN RESTRAINED AS A RESULT OF PLACEMENT WITHIN A SUBINTIMAL SPACE OR UNDERNEATH PLAQUE. IT IS ALSO POSSIBLE THAT THE INITIAL KINK IN THE INNER LUMEN WAS MADE DURING IAB INSERTION AND THAT IABP CONTINUED TO CYCLICALLY STRESS THE INNER LUMEN AT THAT POINT.
THE IAB WAS PLACED INTO THE PT ON 9/13/96 DUE TO SEVERE DISEASE. THE NURSE NOTED THAT THE PUMP ALARM SOUNDED ON 9/17/96. THE IAB WAS REMOVED WITHOUT DIFFICULTY AND NO SECOND WAS INSERTED. BLOOD WAS NOTED IN THE PUMP'S SAFETY DISK. APPROX 6 HRS LATER, THE PT BECAME SYMPTOMATIC AND ANOTHER IAB WAS INSERTED. THE PT WENT DIRECTLY TO OPEN HEART SURGERY ON 9/17/96.
X-TUBE ASSEMBLY 19" X 17". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
THE EZ35W WAS USED DURING AN UNKNOWN PROCEDURE. THE DEVICE FIRED ON THE FIRST FIRING, BUT SECOND FIRING WOULD NOT FIRE. ANOTHER EZ35 WAS OPENED TO COMPLETE THE CASE. THERE WAS NO BUTTRESSING MATERIAL USED. THERE WAS NO CONSEQUENCE TO THE PT.
EES #:964841. A1,2,3,4; B3,6,7; D10 CONTACTED OFFICE MANAGER. INFO NOT SUPPLIED. D5; H4,6 INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. D6 INFO UNAVAILABLE. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT "WOULD NOT FIRE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE, AFTER VERESS NEEDLE WAS IN PLACE, TROCAR INSERTED, DR WAS HAVING TROUBLE SEEING THROUGH SCOPE AND PROCEDURE WAS ABORTED.
THIS SCOPE IS OVER 12 YRS OLD. THE IMAGE WAS FOUND TO BE A LITTLE BLURRY AND WE SUGGESTED HOSP HAVE IT REFUBISHED. THE SCOPE WAS ALSO EVALUATED BY OTHER SURGEONS AT THE HOSP AND WAS FOUND TO HAVE ACCEPTABLE IMAGE. HOSP SUSPECTED THE SURGEON NEVER REACHED THE PERITONEAL CAVITY BEFORE TH PROCEDURE WAS CALLED OFF.
DR PERFORMED CABGX3 AND VENTRICULAR ANEURYSM REPAIR ON 54 YRS FEMALE ON 9/26/96. REPORTED EJECTION FRACTION PRIOR TO SURGERY 13%. FIRST IAB UNABLE TO INSERT. D/T TECH ERROR. INFLATING RATHER THAN ASPIRATING, 2ND IAB INSERTED AND NOT SOME DIFFICULTY W/COMPETITOR PUMP AT 2AM DR CHANGED THE IAB AND SWITCHED OUT PUMP PT STABLE.
H11-ALL UNK INFO REQUESTED BUT NOT RECEIVED. H11-SECTION F PROVIDED BY MFG. H11-SECTION F10 DEVICE CODE 1746 LABELED. H-10 SECTION D5/F9/H4 NO INFO AVAILABLE.
THE DISPOSABLE LOADING UNIT WAS USED WITH AN INSTRUMENT DURING AN ABDOMINAL HYSTERECTOMY. REPORTEDLY, THE STAPLES DID NOT LOCK. THE SURGEON APPLIED SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PT HAD BILATERAL AUGMENTATION IN 1978. DESIRES THAT IMPLANTS BE EXCHANGED. RIGHT IMPLANT LEAKING, LEFT IMPLANT INTACT.
IT WAS REPORTED TO CO THAT THE BALLOON BURST DURING A PROCEDURE. THE DEVICE WAS POSITIONED AND INFLATED WITHOUT PROBLEM. IT WAS DE-INFLATED AND WHEN THEY TRIED TO RE-INFLATE THE BALLOON, IT BURST. THERE WAS NO CONSEQUENCE TO THE PT. THE VESSEL WAS CHECKED BY ANGIOGRAPHY AND THE DEVICE WAS REMOVED AND THE PROCEDURE ENDED.
DURING THE ANALYSIS IT WAS OBSERVED THAT THE BALLOON WAS ELONGATED, IT HAD TAKEN A HALF MOON SHAPE, AND BURST LONGITUDINALLY ON A SEGMENT BETWEEN THE STRETCHED COIL AT THE PROXIMAL END AND THE MID SECTION OF THE BALLOON. ADDITIONALLY, THE BALLOON DIAMTER WAS STRETCHED TO APPROX 3.2 MM FROM A NOMINAL OF 2.5 + 0.2MM. FROM BENCH TEST IT IS KNOWN THAT THE BALLOON WILL ELONGATE WHEN IT IS OVER INFLATED. NO INFO WAS PROVIDED ABOUT THE INFLATION PRESSURE USED DURING THE PROCEDURE. PER LABELING INSTRUCTIONS: "WARNING. DO NOT EXCEED 80 PSI (5.4 ATM) DURING BALLOON INFLATION." THE CONDITION OF THE RETURNED PRODUCT INDICATES THAT THE MAXIMUM RECOMMENDED INFLATION PRESSURE WAS EXCEEDED. DURING THE IN-PROCESS INSPECTION THE LOT WAS TESTED FOR BURST PRESSURE. THE ACCEPTANCE CRITERION WAS THAT BALLOON SHOULD STAND A MINIMUM PRESSURE OF 180PSI. THE SAMPLE MEAN WAS 225 PSI AND THE LOT WAS ACCEPTED. THE CONDITION OF THE RETURNED CATHETER INDICATED THAT CO'S RECOMMENDATIONS ABOUT THE MAXIMUM INFLATION PRESSURE OF THE DEVICE WERE NOT FOLLOWED. THIS INFO IS BASED ON INFO SUPPLIED TO US WITHOUT OUR INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA INGUINALIS PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE. THE COMPONENT WAS RETRIEVED WITHOUT INCIDENT.
10/17/96- MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
EES #:964848. A1,2,3,4; B6,7; D10 SURGEON CONTACTED. INFO NOT SUPPLIED. D5,6,H4 PRODUCT NOT RETURNED FOR ANALYSIS. INFO NOT AVAILABLE. H6 INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
9/24/96 THE SURGEON STATED HE ACCIDENTALLY PARTIALLY FIRED THE BLACK HANDLE. IT WOULD NOT STAPLE OR CUT. HE FELT THERE SHOULD BE A SAFETY MECHANISM IN PLACE TO PREVENT THIS. HE OPENED ANOTHER DEVICE AND IT WORKED FINE. KJB
IT WAS REPORTED THAT DURING A PTCA PROCEDURE, DIFFICULTY WAS ENCOUNTERED DEFLATING THE BALLOON. THE BALLOON WAS DEFLATED ENOUGH TO REMOVE WITHOUT INCIDENT. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS VERIFIED THE REPORTED DEFLATION DIFFICULTY. ANALYSIS REVEALED A KINK IN THE INFLATION LUMEN. THE SHAFT KINK MAY HAVE RESTRICTED FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED.
SHUNT MALFUNCTIONING BY NO DRAINING PROPERLY. REMOVAL OF LUMBAR PERITONEAL SHUNT DUE TO T5 RADICULITIS.
IT WAS REPORTED THE SWITCH REMAINED IN THE "ON" POSITION. INSPECTION REVEALED NO DEFECT WAS FOUND. THE EVENT COULD NOT BE DUPLICATED. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
THE SAMPLE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION REVEALED THAT THE SILICONE SEGMENT WAS SEPARATED FROM THE ADAPTER/SILICONE TUBING ENGAGEMENT. THE SEGMENT WAS RECONNECTED AND TESTED. THE JUNCTION HELD WITHIN PRODUCT SPEC. THIS JUNCTION IS A FRICTION FIT ENGAGEMENT AND IS NOT BONDED. IT IS KNOWN THAT EXCESS PRESSURE OR PULLING FORCES, AS EXHIBITED DURING IV PUSH WILL RESULT IN SET SEPARATION. IT IS RECOMMENDED THAT THE TUBING BETWEEN THE PUSH SITE AND THE PUMP SEGMENT BE CLAMPED TO PREVENT PRESSURE FROM REACHING THE PUMP SEGMENT, OR SEPARATION MAY OCCUR. D5 EXPIRATION DATE IS 5 YEARS FROM MANUF DATE. NO SERIAL NUMBER FOR THIS PRODUCT, SHOULD BE NA. D10 UNK. F13 MEDWATCH REPORT REC'D 9/11/96 FROM USER FACILITY.
THE DEVICE WAS SUPPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE PNEUMOPERITONEUM LEAKED FROM THE DEVICE. THE SURGEON COMPLETED THE PROCEDURES WITH THE SAME INSTRUMENT. THE HSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/17/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSIONOF INITIAL REPORT TO FDA BY MFG. THE PRODUCT WAS NOT RETURNED FOR EVALUATION.
THE RPTR INDICATED THAT COMPLETE LOSS OF ATRIAL CAPTURE WAS OBSERVED.
9/10 CORONARY BY PASS X3 AND BILATERAL CAROTID ENDARTERECTOMY, IN ICU ON VENT, IV NITROGLYCERINE, NIPRIDE AND DOPAMINE. SYSTOLIC BP SUDDENLY ROSE TO 250 SYSTOLIC. SYRINGE PUMP INFUSING NITROGLYCERINE NOTED TO HAVE STOPPED RUNNING. (NO ALARMS ON THIS MODEL). QUICKLY SWITCHED TO ANOTHER SYRINGE PUMP. BP NORMALIZED WITHOUT FURTHER INTERVENTION. AT HIGH RISK FOR POST OPERATIVE COMPLICATIONS FROM UNCONTROLLED BP, DUE TO TYPE OF SURGERY AND FAILURE OF SYRINGE PUMP. NO COMPLICATIONS NOTED AT THIS TIME.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. SURGEON COMPLAINED THE GUN MISFIRED/STAPLES JAMMED. A SECOND DEVICE WAS OPENED AND SURGEON EXPERIENCED SAME PROBLEM. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: BROKEN NOSE WELD. RESULTS OF EVALUATION: CONCLUSION: A)IT WAS CONCLUDED THAT THE REPORTED INST. "MISFIRED STAPLES. THE INSTR. WAS RECEIVED WITH THE TRIGGER IN THE PRECOCKED POSITION AND WITH EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY. THE LIFTER WAS STICKING DUE TO THE EXESSIVE DRIED FLUIDS AND THE CARTRIDGE NOSE WELD WAS OBSERVED TO BE BROKEN. NO CONCLUSION COULD BE REACHED AS TO HOW THE NOSE WELD HAD BROKEN  AND NO FUNCTIONAL TESTING COULD BE PERFORMED. B)IT WAS CONCLUDED THAT THE INSTR. WAS CONFORMING WITH REGARD TO STAPLES FEEDING, FIRING AND FORMING. THE INSTRUMENT WAS RECEIVED WITH A STAPLE PROTRUDING OUT OF THE CARTRIDGE NOSE. THE INSTRUMENT WAS EXAMINED, WAS FOUND TO BE FUNCTIONAL, AND WAS CYCLED AND FIRED THE REMAINING 11 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INST. "JAMMED". EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY.
PT ORIGINALLY HAD RIGHT HEMICOLECTOMY ON 9/21/96. ON 9/26/96, THE MD BROUGHT HIS PT BACK TO OR FOR EXPLORATION OF FREE AIR IN THE ABDOMEN. UPON EXPLORATION HE IDENTIFIED A PERFORATION IN THE ANASTOMOSIS MADE WITH STAPLER. HE AGAIN ATTEMPTED TO UTILIZE SUSPECT MEDICAL DEVICE, BUT FAILED TO FIRE CORRECTLY. ANASTOMOSIS REPAIRED BY HAND.
PER MEDWATCH THIS PUMP WAS IN USE ON A POST OP PT. PUMP WAS DELIVERING NITROGLYCERINE AND STOPPED RUNNING. SUBSEQUENTLY THE PT'S BLOOD PRESSURE ROSE TO 250 SYSTOLIC. THE PUMP WAS QUICKLY SWITCHED TO ANOTHER SYRINGE PUMP, BP NORMALIZED WITHOUT FURTHER INTERVENTION. RPTR STATED IN THIS REPORT THAT THE PUMP DOES NOT HAVE ALARMS. THIS STATEMENT IS INCORRECT.
SECTION F COMPLETED BY THE REPORTER. EVALUATION SUMMARY: CHECKED OPERATIONS. REPEATED TWO ADD'L TIMES TO VALIDATE NORMAL OPERATIONS. CHECKED PUMP FOR VISUAL MISUSE OR ABUSE, SUCH AS MISSING PARTS, BROKEN PARTS, ETC. E15 ERROR CODE IS A FAIL SAFE. THE UPPER PLUNGER RIGHT ARM STOP WAS FOUND BROKEN; THIS DOES NOT AFFECT THE FLOW OR OPERATION OF THE UNIT. THE DEVICE RAN AT THE RATE PROVIDED IN THIS REPORT. THE SYRINGE WAS RUN FROM 60 CC UNTIL EMPTY. THE TESTS WERE REPEATED THREE TIMES WITH NO PROBLEMS, ALARMS, OR FAILURES.
DURING A TURP THE WHITE PLASTIC OF A RESECTOSCOPE BROKE OFF AND BECAME LODGED IN THE PT'S PROSTATE. THE PT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER FACILITY DUE TO A BLEEDING PROBLEM UNRELATED TO THIS INCIDENT.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. SEVERAL CLIPS DID NOT FORM ON THE VESSEL. THE CLIPS WERE REMOVED. ANOTHER ER320 WAS OPENED AND CASE CONTINUED WITHOUT INCIDENT. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: YIELDED JAWS. RESULTS OF EVAL: CONCLUSION-BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS-IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOSLY IMPROVE PRODUCTS.
THE CUSTOMER ALLEGED THE VENTILATOR STOPPED CYCLING AND ENTERED INTO "SAFETY VALVE OPEN" MODE. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE CORRESPONDING ERROR CODE. THE CSE COULD NOT DUPLICATE THE EVENT, BUT AS A PRECAUTION REPLACE THE PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD ALONG WITH ONE OF THE AUTO-ZERO SOLENOIDS. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVNET ALLEGED IN THIS REPORT.
THE SAMPLE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION REVEALED THAT THE SET HAS SEPARATED AT THE AIR-IN-LINE ADAPTER/SILICON TUBING ENGAGEMENT. THE DISTAL PORTION OF THE SET WAS RETURNED WITHOUT THE SILICONE TUBING, THEREFORE HE ENGAGEMENT STRENGTH COULD NOT BE TESTED. THE ROOT CAUSE FOR THE SEPARATION COULD NOT BE DETERMINED. D5 EXPIRATION DATE IS 5 YRS FROM MFG DATE. NO SERIAL NUMBER FOR THIS PRODUCT, SHOULD BE NA. D10 UNK. F13 MEDWATCH REPORT REC'D 9/11/96 FROM USER FACILITY.
DURING ELECTIVE PTCA PROCEDURE, A GUIDE WIRE BROKE OFF IN THE CIRCUMFLEX CORONARY ARTERY AND COULD NOT BE RETRIEVED DESPITE MANY ATTEMPTS TO DO SO. PT REQUIRED OPEN HEART SURGERY TO REMOVE WIRE.
PT TRIPPED AND FELL AT HOME AND INJURED HER LEFT ARM IN EARLY 8/96. ON 8/16/96 ADMITTED TO HOSP FOR A LEFT MID/DISTAL HUMERAL SHAFT FRACTURE AND IMPLANTED WITH A SMALL FRAGMENT SYSTEM AND 3.5MM UNIVERSAL RECONSTRUCTION RIBBON. ON 9/9/96 RECONSTRUCTION RIBBON APPEARED TO BE BROKEN. ON 9/13/96 BROKEN RIBBON REMOVED. ALL PIECES REMOVED FROM PT.
H6-REVIEW OF PRODUCTION RECORDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE DATA INDICATES THAT ALL PRODUCTS WITHIN THIS LOT WERE MFG IN CONFORMANCE WITH ALL DESIGN REQUIREMENTS. THE DEVICE WAS RETURNED AND IT WAS BROKE. THE DEVICE WAS EVALUATED AND IT MET SPECIFICATIONS. THIS DEVICE WAS MFG IN 1996.
FEEDING PUMP SET AT 20CC/HR AND INITIATED AT 11:55 AM. AT 1435 DISCOVERED THAT 800 CC OF FLUID HAD BEEN DELIVERED.
THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER, A 3RD PARTY RENTAL AGENCY, STATED THE END USER ALLEGED THE VENTILATOR FAILED TO DELIVER ANY VOLUME. A BIO-MED AT THE AGENCY WAS UNABLE TO STATE WHETHER THE UNIT'S ALARM SYSTEM ACTIVATED. AFTER EVALUATING THE UNIT AND NOT BEING ABLE TO REPRODUCE THE REPORTED PROBLEM, THE BIO-MED RETURNED THE UNIT TO THE END USER. THE END USER RAN THE UNIT FOR 24 HRS BEFORE RETURNING IT TO SVC. IT IS NOT VERIFIED THAT THE UNIT MALFUNCTIONED AT ANY TIME. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE. THE DEVICE WAS EVALUATED BY A 3RD PARTY RENTAL AGENCY. CO WAS NOT AUTHORIZED TO INSPECT OR EVALUATE THE DEVICE. THE 3RD PARTY BIO-MED REPORTED THE RESULTS OF HIS FINDINGS TO CO.
DURING AN ENDOSCOPIC PROCEDURE, THE LETTERING FROM THE HANDLE OF THIS ENDOSCOPE WAS FOUND IN THE PT'S NOSE. THE LETTERING WAS REMOVED AND THE NASAL PASSAGES CHECKED FOR FURTHER DEBRIS.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. THE INITIAL CONTACT HAS INDICATED THAT THIS ENCOSCOPE WAS STERILIZED IN ANOTHER STERILIZER. THIS STERILIZATION PROCESS MAY HAVE BEEN THE CAUSE FOR THE LETTERING COMING OFF THE HANDLE OF THE ENDOSCOPE. ALL LETTERING HAS BEEN REMOVED FORM THE   ENDOSCOPE AND THE INSTRUMENT HAS BEEN RETURNED TO THE USER.
A 12-YR-OLD FEMALE WAS UNDERGOING PERCUTANEOUS FIXATION OF THE LEFT HIP WHEN THE GUIDE WIRE WAS INADVERTANTLY DRIVEN INTO THE ABDOMINAL CAVITY. IT WAS REMOVED WITHOUT PENETRATING INJURY TO THE PT. PT WAS DISCHARGED IN GOOD CONDITION.
THE SVC REORT SHOWS THE DEVICE FAILED LEAK TESTING DURING PREVENTIVE MAINTENANCE. THE SVC TECH INSPECTED THE DEVICE AND ADJUSTED THE SAFETY DUMP SPRING. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVNET ALLEGED IN THIS REPORT.
WHILE OPENING THE OUTER BLISTER, THE INNER STERILE BLISTER OPENED AT THE SAME TIME. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A VISUAL INSPECTION OF THE RETURNED PRODUCT INDICATED THAT THE INNER TYVEK LID WAS NOT PROPERLY PLACED/ALIGNED ON ITS BLISTER, AND AS A RESULT, ONE SIDE OF THE TYVEK LID WAS OVERHANGING. THIS OVERHANG WAS SUFFICIENT TO CREATE A SLIGHT OVERLAP BETWEEN THE INNER BLISTER LID AND THE SEALING PORTION OF THE OUTER BLISTER COMBINATION WAS MODIFIED TO INCLUDE RECESSING THE INNER BLISTER INSIDE THE OUTER BLISTER.
THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.6 IS THE DATE THE USER FACILITY BECAME AWARE OF THE EVENT. DATE ENTERED IN SECTION F13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS REC'D BY THE MFR.
THIS 76-YR-OLD MALE HAD UNDERGONE SURGERY ON HIS RIGHT KNEE. A DRAIN WAS PLACED IN THE KNEE IN SURGERY AND WHEN IT WAS REMOVED, THE TUBING BROKE OFF LEAVING A PART OF THE DRAIN TUBING IN THE KNEE. THIS PT WAS TAKEN TO SURGERY ON 9/23/96 FOR REMOVAL OF THE TUBING.
A COMPLAINT WAS RECEIVED FROM THE WIFE OF A 61 YR OLD INSULIN DEPENDENT DIABETIC WHO ADJUSTS INSULIN BASED ON INSTRUMENT READINGS. SHE STATED THAT HER HUSBAND HAD BEEN RECEIVING LOWER RESULTS IN THE LOW 100'S. BECAUSE OF THESE RESULTS HER HUSBAND DECIDED NOT TO TAKE HIS INSULIN FOR 2 (TWO) DAYS. ON 8/8/96, HE WOKE UP AND VOMITED. HE WAS TAKEN TO THE DR WHERE A BLOOD GLUCOSE READING WAS 668MG/DL. HE WAS TRANSFERRED TO THE CRITICAL CARE UNIT IN A STATE OF KETO-ACIDOSIS. WHILE IN THE HOSPITAL THEY RAN COMPARISON BETWEEN THE COMPLAINANT'S METER AND THE HOSPITAL'S METER. THERE WAS USUALLY 100 MG/DL DIFFERENCE. TECHNIQUE WAS REVIEWED AND IT WAS DISCOVERED THAT CHECK PADDLE RESULTS WERE SATISFACTORY. HOWEVER, CONTROLS COULD NOT BE TESTED BECAUSE THE CONTROL SOLUTION EXPIRED. A REQUEST WAS MADE TO RETURN THE SYSTEM FOR EVAL.
REAGENT STRIPS WERE RETURNED FOR EVALUATION. PERFORMANCE TESTING CONFIRMED LOW BLOOD RESULTS. WHILE TESTING OF AN IN-HOUSE SAMPLE OF THE SAME LOT WAS ACCEPTABLE. PERFORMANCE CHARACTERISRICS SUCH AS THESE USUALLY INDICATES THAT THE REAGENT MAY HAVE BEEN IMPROPERLY STORED OR HANDLED BY THE CUSTOMER. THE CUSTOMER WAS CONTACTED AND INFORMED OF THE EVAL. SHE STATES THAT THE REPLACEMENT PRODUCT IS WORKING WELL AND WILL CALL IF THERE ARE ANY ADD'L PROBLEMS OR CONCERNS. THE COMPLAINT IS CONSIDERED CLOSED.
THE CUSTOMER REORTED A LOSS OF POSITIVE END EXPIRATORY PRESSURE (PEEP). THE CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THAT THE SET PEEP WENT TO ZERO CMH20 AFTER ONE MIN. THE CSE INSPECTED THE DEVICE AND REPLACED THE AUTOZERO SOLENOIDS. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO. THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVNET ALLEGED IN THIS REPORT.
THE NAIL BROKE AND WAS REMOVED. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME REPORTED AT THIS TIME.
THE CORRECT STRENGTH OF THE MATERIAL AND THE FEATURES OF THE FRACTURE HINT, THAT THE NAIL FRACTURED AN ACCOUNT OF MATERIAL FATIGUE.
THIS PHACOEMULSIFICATION HANDPIECE PRODUCED EXCESSIVE BUBBLES DURING A CATARACT EXTRACTION PROCEDURE AND WAS EXCHANGED FOR ANOTHER.
THE CUSTOMER ALLEGED THERE WAS A NO ALARM CONDITION. THE CSE INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF TESITNG. THE CSE REPLACED THE CONVERSION PCB AS A PRECAUTION. IT IS NOT VERIFIED THAT THE ALARM WAS NON FUNCTIONAL, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
DURING A CATARACT EXTRACTION PROCEDURE, THIS OPTHALMIC MICROSURGICAL UNIT RESET. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE.
DISTRIBUTOR BECAME AWARE OF TWO EVENTS INVOLVING PERCUTANEOUS FEEDING DEVICES. BOTH PEG'S WERE INITIALLY PLACED WITHOUT INCIDENT. SOMETIME POST PLACEMENT THE FEEDING DEVICES MIGRATED INTO THE PERITONEAL WALL REQUIRING SURGICAL REMOVAL. NEW FEEDING DEVICES WERE PLACED IN BOTH INSTANCES AND THERE WERE NO PT COMPLICATIONS. NO FURTHER DETAILS ARE AVAILABLE WITH REGARDS TO THE CIRCUMSTANCES SURROUNDING THESE EVENTS. NO INFO OBTAINED TO DATE IDENTIFIES ANY PRODUCT MALFUNCTION WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. WITHOUT FURTHER INFO CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. DIRECTIONS FOR USE FOR THIS DEVICE STATE: "AVOID EXCESSIVE PULLING ON THE FEEDING TUBE AS THIS MAY CAUSE THE INTERNAL BOLSTER TO EMBED AGAINST THE GASTRIC MUCOSA. THE RESULT CAN BE TISSUE NECROSIS, TUBE MIGRATION, INFECTION AND ASSOCIATED SEQUELAE."
THE SURGEON WAS IMPACTING THE HUMERAL NAIL WITH THE IMPACTOR DRIVER, BY STRICKING THE IMPACTOR DRIVER WITH A HAMMER. DURING IMPACTION, THE HUMERAL NAIL HOLDING BOLT BROKE ABOVE THE THREADS. THE DEVICE WAS IMPLANTED SUCCESSFULLY WITHOUT THE BOLT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT DUE TO THIS EVENT.
THE ITEM RECEIVED WAS BROKEN OFF AT THE FIRST WINDING OF THE THREAD. THE THREADED FRAGMENT IS MISSING. DESIGN AND CATALOG NUMBER INDICATE AN OLD VERSION OF THE INSTRUMENT. THE ORIGINAL ROUNDED HEAD IS FLATTENED BY IMPACTS. THE UNDERSURFACE OF THE KNURLED HANDLE SHOWS SIGNS OF IMPACT. IMPACTS UPON AN UPTIGHT NAIL HOLDING BOLT WILL INEVITABLY LEAD TO THIS TYPE OF EVENT.
A BALLOON RUPTURED ON THE FIRST INFLATION AT SIX ATMOSPHERES DURING AN ILIAC ANGIOPLASTY OF AN EXTREME CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. SINCE CO'S FOLLOW UP INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION, CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT.
A BALLOON RUPTURED ON THE FIRST INFLATION AT SIX ATMOSPHERES DURING AN ILIAC ANGIOPLASTY OF AN EXTREME CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED.
THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER HANDPIECE WAS UDED TO SUCCSSFULLY COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.6 IS THE DATE THE USER FACILITY BECAME AWARE OF THE EVENT. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAAILURE WAS REC'D BY THE MFR.
CUSTOMER REPORTED THAT THE SAMPLE HANDLER FAILED TO PIPETTE REAGENT INTO POSITION A6 DURING AN HCV ASSAY AND DID NOT GENERATE AN ERROR MESSAGE. AN INVESTIGATION IS IN PROGRESS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
THE DEVICE FAILED THE LEAK TEST DURING PERFORMANCE OF AN INCOMING EVALUATION. THE SERVICE TECHNICIAN INSPECTED THE DEVICE AND ADJUSTED THE SAFETY DUMP SPRING. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TOTHE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE UNIT REPEATEDLY ALARMED "OCCLUSION". PT SUFFERED FROM THE SOLUTION INFUSING INTO TISSUES. THE HOSPITAL REQUESTED A ROUTINE CHECK OF THE PUMP DUE TO NURSING BEING BROUGHT BEFORE A DISCIPLINARY COMMITTEE AS A RESULT OF THE INTRAVENOUS INFILTRATION IN THE PT. APPARENTLY THE INFUSION SITE WAS NOT  INSPECTED AS PER THE USUAL PROTOCOL. THE PT HAS RECOVERED FROM THE INCIDENT.
ORIGINAL REPORT OF INTRAVENOUS INFILTRATION WAS NOT DUE TO THE DEVICE. DURING ROUTINE TEST OF THE DEVICE, IT WAS FOUND THAT THE DELIVERY ACCURACY WAS NOT WITHIN SPECIFICATIONS.
NON DELIVERY OF SECONDARY SOLUTION REPORTED. THE PUMP WAS SET TO INFUSE AN ANTIBIOTIC IN AN UNSPECIFIED AMOUNT OF SOLUTION VIA SECONDARY LINE AT 100 ML/HR. A NURSE REPORTED THAT THE SECONDARY CONTAINER WAS HUNG BEHIND THE LARGER PRIMARY CONTAINER AND WAS NOT READILY VISIBLE TO HER. THE SECONDARY DID NOT INFUSE AT ALL, WHILE THE PRIMARY INFUSED AT THE PROGRAMMED RATE. THE PUMP DOES NOT HAVE CONCURRENT DELIVERY CAPABILITY. THE PRIMARY FLUID WAS AN UNSPECIFIED MANINTENANCE HYDRATION FLUID TO RUN AT 100 ML/HR. THE INCIDENT DID NOT CAUSE ANY ADVERSE EFFECTS TO THE PT. THE ANTIBIOTIC WAS INFUSED LATE AND THE TIMING OF DOSAGE WAS RE-SCHEDULED.
WHILE PERFORMING A PREVENTATIVE MAITENANCE SERVICE THE CUSTOMER SUPPORT ENGINEER DISCOVERED THE FILTER HEATER TO BE DAMAGED AND NONFUNCTIONAL. THE CSE REPLACED THE FILTER HEATER CONNECTOR AND AFTER PASSING ITS PERFORMANCE VERIFICATION TESTS THE UNIT WAS RETURNED TO SERVICE. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER HIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
RT FRONTAL CRANIOTOMY AND ANEURYSM CLIPPING ON 9/4. ANGIO ON 9/5 SHOWED CLIP NOT IN PROPER PLACE. PT RETURNED TO SURGERY ON 9/6. CLIP BEING RETURNED FOR TESTING.
POSSIBLE UNDERDELIVERY REPORTED. THE PUMP HAD BEEN SET TO INFUSE AT A PRIMARY RATE OF 145ML/HR WITH A CONCURRENT SECONDARY INFUSION OF 20 ML/HR. DURING THE SHIFT, THE PRIMARY RATE WAS DECREASED TO 125 ML/HR AND THE SECONDARY WAS DISCONTINUED. WHEN CLEARING THE PUMP AT SHIFT CHANGE, THE MINIMUM EXPECTED DELIVERED VOLUME WAS 1000 ML. THERE WERE NO ADVERSE EFFECTS TO THE PT.
THE REPORTED EVENT COULD NOT BE DUPLICATED DURING TESTING. FREQUENCY OF OCCURRENCE OF DEATH OR SERIOUS INJURY UNDERDELIVERY COMPLAINTS IS ABOUT .05 MILLION SETS USED.
ON 10/17/96, USER INFORMED SVC REP THAT FILTER MOUNT LOCKING PIN WAS BENT AND WEDGE TRAY LOCKING PIN HAD WORKED LOOSE. REPLACEMENT PART ORDERED. SVC REP CALLED USER TO SCHEDULE THE REPAIR. USER INQUIRED IF THE CHECK SPECIFIED IN THE SVC BULLETIN DATED 12/28/89, HAD BEEN COMPLETED ON LAST PREVENTATIVE MAINTENANCE INSPECTION ONE WK PRIOR TO EVENT. SVC REP INFORMED HER THAT IT HAD. ON 10/18/96, SVC REP RECEIVED PARTS AND ARRIVED AT USER FACILITY AT 1:25 PM. REP WAS INFORMED HE MUST WAIT UNTIL THEY WERE FINISHED TREATING PTS. REP WAS GIVEN MACHINE AT 2:00 P.M. AND BEGAN THE REPAIR. REP REPORTED THAT THE WEDGE TRAY LOCKING PIN WAS NOT LOOSE. THE FILTER MOUNT LOCKING PIN WAS BENT. REP REPORTED THAT THE BLOCK MOUTING TRACK WAS BENT. WHEN HE ASKED THE OPERATOR, SHE INFORMED HIM THAT IT WAS BENT BECAUSE IT HAD FALLEN OUT. SHE DID NOT KNOW WHY HE WAS NOT INFORMED SOONER. HE REPORTS THAT THIS WAS THE 1ST TIME HE WAS INFORMED ABOUT IT. OPERATORS AT USER FACILITY CHECKED THE REPAIR AND AGREED THAT IT WAS FIXED. ON 10/18/96, USER FACILITY CALLED THIS OFFICE TO COMPLAIN ABOUT THE PROBLEM. THIS IS WHEN CO BECAME AWARE OF THE PROBLEM. ABOVE INFO RECEIVED 10/21/96, IN REPORT FROM SVC REP.
LOCKING PIN WHICH HOLDS FILTER MOUNT TO COLLIMATOR HEAD WAS BENT. THE DESIGN IS SUCH THAT IT CANNOT BE BENT FROM NORMAL USE BUT FROM MISUSE (EITHER TRYING TO MOUNT THE UNIT THE WRONG WAY OR BY NOT HAVING THE PIN RETRACTED WHEN SLIDING IT ON THE COLLIMATOR HEAD, THE USER DID NOT SAY WHICH CONDITION OCCURRED. ONCE THE PIN IS BENT, IT CAN RESULT IN THE UNIT FALLING OFF THE COLLIMATOR HEAD, BUT ONLY AT AN ANGLE WHERE THE PT IS NOT LIKELY TO BE INJURED. HOWEVER, THE POSSIBILITY WOULD EXIST FOR AN OPERATOR TO BE INJURED, WHICH IS WHY REMEDICAL ACTION WAS NECCESSARY. PART OF CO'S PREVENTATIVE MAINTENANCE INSPECTION REQUIRED CO TO CHECK THE SCREWS WHICH HOLD THE ACCESSORY FILTER MOUNT, CONE HOLDER, ETC. LATCHING MECHANISMS AS PER THE SVC BULLETIN DATED 12/28/89. THESE SCREWS WORK LOOSE OVER TIME AND MAY NOT SECURE ACCESSORIES AS THEY ARE DESIGNED TO DO. THOUGH CO TIGHTENS THESE SCREWS DURING PMI, THEY CAN STILL BECOME LOOSE IN THE TIME BETWEEN SCHEDULED MAINTENANCE. LOCTITE SHOULD BE USED ON ALL SCREWS ON THE ACCESSORIES SINCE THESE PARTS GET A LOT OF USE (AND ABUSE). THIS SHOULD FURTHER REDUCE THE CHANCE OF PROBLEMS WITH THE LATCHES WORKING LOOSE AND CREATING A POTENTIALLY HAZARDOUS SITUATION FOR OPERATORS AND PTS.
THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER ALLEGED THE LOSS-OF-POWER ALARM FAILED TO ACTIVATE WHILE THE UNIT WAS UNDERGOING SERVICE. THE CUSTOMER'S BIOMEDICAL TECHNICIAN, REMOVED AND REPLACED THE POWER SWITCH UTILITY HARNESS AND BATTERIES. IT WAS NOT VERIFIED BY THE CO THAT THE UNIT'S ALARM FAILED TO ACTIVATE, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE. THE HSP'S BIO-MEDICAL STAFF PROVIDES ITS OWN-HOUSE REPAIRS. CO WAS NOT AUTHORIZED TO REPAIR THE DEVICE.
DURING THE PROCEDURE THE SHAFT OF THIS DEVICE SPLIT. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED F OR CO'S ANALYSIS.
DURING THE PROCEDURE THE SHAFT OF THIS DEVICE SPLIT. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR OUR CO ANALYSIS.
H3. VISUAL INSPECTION DISCOVERED SCRATCHES ON THE CASSETTE AND THE CASSETTE APPEARED USED. THE CASSETTE WAS TESTED FOR FUNCTIONALITY UTILIZING A MICROSURGICAL SYSTEM. THE CASSETTE FUNCTIONED PROPERLY. NO DEFECTS WERE FOUND, CASSETTE MEETS SPECIFICATIONS. CO HAS NOTIFIED MFR THAT THE PROBLEM MAY LIE WITH THE SURGICAL SYSTEM BEING USED.
DURING THE PROCEDURE THE FITTING ON THIS DEVICE WAS DEFECTIVE. REPORTEDLY, THE CATHETER BECAME DISCONNECTED FROM THE TUBING. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE. THE DEVICE IS NOT BEING RETURNED FOR CO'S ANALYSIS.
THE INSTRUMENTS WERE USED DURING A THORACOSCOPY. IT WAS REPORTED THE SURGEON HEARD A CRACK UPON FIRING THE DEVICE AND THE INSTRUMENT MISFIRED. SURGEON ALSO USED DEVICE AND UPON FIRING COULD NOT GET THE HANDLES OPENED. THERE WAS NO CONSEQUENCE TO THE PT.
CO#964803-2. A1,2,3,4; B6,7; D10 CONTACTED SURGEON. INFO NOT AVAILABLE. D5;H4, 6 INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAM, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT OPEN" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, OPENED, AND FORMED THE STAPLES WITH DESIGNED SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT JAMMED. THE SURGEON MANIPULATED THE DEVICE OFF THE TISSUE AND APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED NO PT INJURY.
DEVICE WAS APPLIED DURING AN END TO END ANASTOMSIS. THE INSTRUMENT DID NOT CONTAIN ANY STAPLES. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/13/96- SUPPLEMENTAL REPORT # 1 SUBMITTED TO FDA. ADD'L DATA ENTERED IN D9. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6.
THE DEVICE WAS USED DURING A REVERSAL COLOSTOMY. IT WAS FIRED ACROSS THE SMALL BOWEL AND THE STAPLES DID NOT FORM. THE SURGEON HAND SEWED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
EES# 964808. A1,2,3,4; B6,7; D10 ATTEMPTED TO CONTACT SURGEON. INFO UNAVAILABLE. D6 INFO UNAVAILABLE. D5: H4,6 INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
THE BURN TROUBLE WAS HAPPENED WITH USING BROKEN IN CO'S CUSTOMER. SENSOR AND A PICTURE OF THE TROUBLE WILL FOLLOW. CO THOUGHT THAT PULSE OXIMETER HAD NO FAULT AND DR ALSO RECOGNIZED THAT THE PROBLEM WAS NOT BECAUSE OF OXIMETER." ENSUING CORRESPONDENCE ALLEGES THAT ON 9/8/96 A MODEL I-20 OXYGEN TRANSDUCER WAS BEING USED WITH A MODEL N-3000 PULSE OXYMETER TO MONITOR A PEDIATRIC PT. ALLEGEDLY, THE I-20 WAS REMOVED FROM THE PT AND AN AREA DESCRIBED AS A 2 CM BURN WAS SEEN AT THE APPLICATIONS SITE.
CO REQUESTED THAT THE EQUIPMENT INVOLVED IN THE ALLEGED INCIDENT BE RETURNED IN ORDER TO INVESTIGATE THE CLAIM. THE I-20 WAS RECEIVED ON 9/27/96 AND WAS EXAMINED BY AN ENGINEER IN CO'S CLINICAL STUDIES DEPT. IT WAS EVIDENT THAT THE I-20 HAD ENDURED MUCH USE. MOST OF THE I-20'S ADHESIVE WRAP WAS NO LONGER INTACT. IT WAS ALSO FOUND THAT BOTH WIRES CONNECTING THE EMITTER WERE BROKEN, THUS RENDERING THE SENSOR INOPERABLE PREVENTING ANY ELECTRICAL CURRENT FROM PASSING THROUGH THE EMITTER OF THE SENSOR. NO EVIDENCE OF THIS SENSOR OVERHEATING COULD BE FOUND. THE PULSE OXIMETER, CABLE AND POWER SUPPLY USED IN CONJUNCTION WITH THIS ALLEGED INCIDENT WERE NOT RETURN TO CO UNTIL 10/15/96. AN INVESTIGATION THAT WILL INCORPORATE ALL OF THE EQUIPMENT USED IN THE ALLEGED INCIDENT IS CURRENTLY IN PROCESS. THE AGENCY WILL BE NOTIFIED OF THE FINDINGS.
AT BEGINNING OF ANESTHESIA INDUCTION. NO FLOW WAS OBTAINED. WHEN THE DEVICE WAS REMOVED FROM THE CIRCUIT, FLOW WAS OBTAINED. OFF THE CIRCUIT, USER COULD NOT OBTAIN FLOW THROUGH THE DEVICE. NO PT EFFECTS WERE REPORTED.
CO'S REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT OF FILTERS REVEALED NO VARIATION FROM STANDARD PRODUCTION. IN SUMMARY, THE BASIS FOR THE DISPARITY BETWEEN THE USER'S OBSERVATION OF FLOW RESISTANCE AND THE FIRM'S INABILITY TO REPRODUCE THE FLOW RESISTANCE IN THE RETURNED DEVICE IS INDETERMINATE.
HCP EXPERIENCED ANAPHYLACTIC REACTION AND OCCUPTIONALLY INDUCED ASTHMA.
AN INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTED DID NOT PROVIDE ANY PRODUCT OR LOT NUMBER INFO.
DURING ROUTINE RETAPING OF PT'S ENDOTRACHEAL TUBES, RT MOVED THE PILOT BALLOON TO FACILITATE TAPING. DURING MOVEMENT OF PILOT BALLOON, THE FULL LENGTH OF PILOT LINE EASILY DETACHED FROM BODY OF ENDOTRACHEAL TUBE CAUSING CUFF TO DEFLATE. THIS RENDERED ENDOTRACHEAL TUBE INEFFECTIVE FOR VENTILATOR USE. PT IMMEDIATELY REINTUBATED WITHOUT APPARENT ADVERSE EFFECT.
PT ADMITTED TO FACILITY FOR REMOVAL OF INTRAVASCULAR FOREIGN BODY. CATHETER HAD SEPARATED FROM PORT AND MOVED TO APEX OF HEART RIGHT VENTRICLE. CATHETER WAS SUCCESSFULLY REMOVED VIA PERCUTANEOUS PUNCTURE RIGHT C.F.V. UNDER FLUOROSCOPIC GUIDANCE.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE ANY PRODUCT OR LOT NUMBER INFO.
PLAINTIFF ALLEGES SEVERE RESPIRATORY PROBLEMS AND OTHER UNEXPLAINED SYMPTOMS AND UNABLE TO WORK IN ANY STANDARD CLINICAL HEALTH CARE SETTING DUE TO EXPOSURE TO AND USE OF LATEX GLOVES.
AN INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTER DID NOT PROVIDE ANY PRODUCT OR LOT NUMBER INFO. LITIGATION PENDING NO CUSTOMER CONTACT ALLOWED.
PLAINTIFF, ALLEGES PHYSICCAL INJURIES, INCLUDING BUT NOT LIMITED TO HAND SORES, HIVES, WHEEZING, HAND DERMATITIS, RUNNY NOSE, OCCUPATIONS ASTHMA, UNEXPLAINED RASHES ON HER BODY, RAPID HEARTBEAT, AND OTHER PHYSICAL INJURIES DUE TO EXPOSURE AND USE OF LATEX GLOVES. PLAINTIFF'S HUSBAND ALLEGES BEING DEPRIVED OF THE LOVE, SERVICES, ADVICE, COMPANIONSHIP AND CONSORTIUM OF HIS WIFE.
CRANIOTOMY WITH IMMUNOTHERAPY SURGERY LASTED APPROX 2 HRS 20 MINS. AN ELECTROCAUTERY KNIFE WAS USED DURING THE SURGERY. THE GROUNDING PAD WAS PLACED ON THE UPPER OUTER THIGH. THE PT'S THIGH WAS NOT SHAVED. UPON COMPLETION OF SURGERY, FOUR SMALL BURN MARKS WERE NOTED ON THE PT AND ON THE GROUNDING PAD.
PLAIJNTIFF ALLEGES SUFFERING PHYSICAL INJURY AND DAMAGE AND HAS CONTRACTED SEVERE AND IRREVERSIBLE TYPE-1 LATEX ALLERGY, WHICH IS BELIEVED TO BE PERMANENT AND LIFE-THREATENING. PLAINTIFF'S SPOUSE ALLEGES LOSS OF CONSORTIUM.
AN INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTED DID NOT PROVIDE ANY PRODUCT OR LOT NUMBER INFO. LITIGATION PENDING NO CUSTOMER CONTACT ALLOWED.
EMT'S ATTENDED TO A PT THAT HAD BEEN DOWN FOR APPROXIMATELY 15 MINS. THE PT WAS CONNECTED TO AN AUTOMATIC EXTERNAL DEFIBRILLATOR (AED) AND REPORTEDLY AND ASYSTOLIC HEART RHYTHM WAS OBSERVED. THE PT'S HEART RHYTHM WAS ANALYZED HOWEVER NO SHOCK WAS ADVISED. RESUSCITATION THERAPY WAS CONTINUED AND THE PT WAS READIED FOR TRANSPORT. ALLEGEDLY THE DEFIBRILLATOR CABLE WAS DISLODGED FROM THE ELECTRODES AND COULD NOT BE FIRMLY RECONNECTED. A SECOND SET OF ELECTRODES WAS THEN IMMEDIATELY USED WITHOUT INCIDENT. RESUSCITATION ATTEMPTS WERE CONTINUED HOWEVER THE PT WAS NOT REVIVED. THE REPORTER INDICATED THE ALLEGED MALFUNCTION DID NOT LIKELY CAUSE OR CONTRIBUTE TO THE DEATH OF THE PT. THE OPINION WAS BASED ON THE LACK OF PT VIABILITY AND THE AVAILBILITY OF A SECOND SET OF ELECTRODES.
THE ELECTRODES WERE DISPOSED OF AFTER THE INCIDENT. THE FACILITY WAS GIVEN ADD'L TRAINING AND OPERATING INSTRUCTION LITERATURE TO CONVEY THE RECOMMEDED METHOD FOR RECONNECTING ELECTRODES WHICH ARE ADHERED TO PTS.
THE DEVICE WAS BEING UTILIZED FOR AN INFUSION OF AN OCCLUDED LEG GRAFT. FOLLOWING THE PROCEDURE, AS THE CATHETER WAS BEING WITHDRAWN THE TIP SEPARATED. THE WIRE WAS STILL ACROSS THE SEPARATED TIP AND THE SHEATH WAS ADVANCED TO COVER THE SEPARATED SEGMENT. THE SHEATH, WIRE GUIDE AND TIP WERE REMOVED TOGETHER. THE PT DID NOT SUSTAIN ANY ADVERSE EFFECT FROM THIS EVENT.
A. 1,4) INFO WAS NOT AVAILABLE. D. 5,6) INFO WAS NOT AVAILABLE. F. 9) LOT NUMBER WAS NOT AVAILABLE. H. 4) WITHOUT LOT NUMBER THIS INFO CANNOT BE DETERMINED. 6) OTHER-DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT WAS RETURNED FOR EVAL. HOWEVER, CO CAN ADVISE IT HAS SEEN TIP SEPARATION ON THIS PRODUCT IN THE PAST. CO HAS INITIATED A VOLUNTARY PRODUCT RECALL OF THIS PRODUCT LINE. CO IS CURRENTLY INVESTIGATING THIS MATTER.
THE PT HAD JUST COMPLETED A TREATMENT PROCEDURE, TREATMENT WHICH USES A FOLEY CATHETER LIKE TREATMENT CATHETER WHICH HAS A BLADDER RETENTION BALLOON. AT THE END OF THE CASE, THE RPTR HAD DIFFICULTY DEFLATING THE CATHETER'S BLADDER BALLOON, AND NO FLUID WSA OBTAINED WHEN DRAWING BACK ON THE BALLOON LUMEN WITH A SYRINGE. USING ABDOMINAL ULTRASOUND, IT WAS CONFIRMED THAT THE BALLOON WAS STILL INFLATED. A SUPRAPUBIC STICK WITH A SPINAL NEEDLE WAS USED UNDER ULTRASOUND GUIDANCE TO SUCCESSFULLY DEFLATE THE BALLOON, PERMITTING CATHETER WITHDRAWAL. RPTR INDICATED THERE WERE NO SEQUELAE TO THE PT. THE CASE WAS PROLONGED APPROX 10 MINS DUE TO THE EVENT.
BLOOD WAS NOTED IN THE BALLOON TUBING AFTER 5 DAYS. NO OTHER IAB WAS REPLACED, PT IS DOING FINE.
H-11 ALL UNK INFO REQUESTED BUT NOT REC'D H-11 SECTION F PROVIDED BY MFR H-11 SECTION F10 DEVICE CODE 1746 LABEL.
A 12 YEAR OLD HOME CARE PT RECEIVED AN OVERDELIVERY OF FORMULA WITH THE PUMP. THE PUMP WAS SET (BY THE PT'S MOTHER) TO DELIVER 237 MLS IN 10 HOURS AND DELIVERED IT ALL IN 4 HOURS. A COAMPETITIVE BRAND PUMP SET WAS BEING USED. THE PT WAS HOSPITALIZED FOLLOWING THE INCIDENT WITH THE FOLLOWING SYMPTOMS: NAUSEA, RETCHING AND ASPIRATING MUCUS. THE PT REQUIRED MEDICAL   INTERVENTION SUCH AS SUCTION AND BREATHING ASSISTANCE, IN PARTICULAR OXYGEN. AS COMPLICATIONS, THE PT DEVELOPED ELECTROLYTE DISTURBANCES, MUCOUS ASPIRATON, CONSTIPATION AND ILEUS. THE PT HAS NOW BEEN RELEASED. FOLLOWING THE INCIDENT, THE MOTHER NOTED THAT THE SILICONE TUBE SEGMENT ON THE COMPETITIVE SET HAD SLIPPED ALL THE WAY TO THE END OF THE DRIP CHAMBER CONNECTION AND WAS NOT HELD TAUT AGAINST THE ROTOR. (NOTE: THIS CONDITION COULD RESULT IN FREE-FLOW).
IMPLANT WAS FRACTURED. PT INJURY HAS NOT BEEN REPORTED.
UPON CHECKING THE PT THEY NOTED ALLOW AUGMENTATION AND BLOOD IN THE TUBING THE IAB WAS TAKEN OUT NO OTHER IAB WAS REPLACED.
H-11 ALL UNK INFO REQUESTED BUT NOT REC'D. H-11 SECTION F PROVIDED BY MFG. H-11 SECTION F10 DEVICE CODE 1746 LABELED.
THE DEVICE WAS BEING UTILIZED THROUGH A GRAFT FOR A DIALYSIS PROCEDURE. THE CATHETER WAS ADVANCED OVER AN .035 WIRE GUIDE; HOWEVER, HUNG UP AT THE SKIN SITE ENTRY SITE. THE CATHETER WAS WITHDRAWN AND THE TIP SEPARATED AT THE SKIN ENTRY SITE. THE PHYSICIAN REMOVED THE TIP FROM THE SKIN SITE BY HAND. THE PT SUSTAINED NO ADVERSE EFFECT FROM THIS EVENT.
A.1) INFO WAS UNAVAILABLE. AN EXAMINATION OF THE RETURNED USED CATHETER CONFIRMED SEPARATION. AT THIS TIME CO IS UNABLE TO DETERMINE WHY THIS IS OCCURRING. CO CAN ADVISE THAT A VOLUNTARY RECALL OF THIS PRODUCT LINE HAS BEEN INITIATED. THE APPROPRIATE PERSONNEL ARE CURRENTLY INVESTIGATING THIS ISSUE.
PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
EXPIRED PT AT NURSING HOME. PT'S SON CLAIMS THE PUMP OVERINFUSED.
AFTER AN ENDOSCOPE EYEPIECE FILTER ASSEMBLY WAS SOAKED FOR DISINFECTION IN 70% ISOPROPYL ALCOHOL, THE OPTICAL FILTER WAS NOTED TO HAVE FALLEN OUT OF THE HOLDER. THERE WAS NO INJURY INVOLVED IN THE INCIDENT. USE OF THE ENDOSCOPE WITHOUT THE FILTER MAY EXPOSE THE CLINICAN TO A LEVEL OF ENERGY HIGHER THAN CDRH STD 1040.10 MPE OF .2 UJ. IT COULD POSSIBLY REACH A LEVEL OF 4.3UJ.
ONE BATCH OF EYEPIECES WAS FOUND TO HAVE BEEN PRODUCED WITH AN INSUFFICIENT AMOUNT OF EPOXY TO RELIABLY HOLD THE LENS IN PLACE. THE CAUSE OF THIS PROBELM WAS TRACED TO THE WAY THE EPOXYING INSTRUCTIONS WERE INTERPETED BY AN ASSEMBLER UNFAMILIAR WITH THE PROCESS. THE PRINTS WERE CLARIFIED AND A FUNCTIONAL TEST ADDED TO THE PROCESS. WE NOTIFIED THE 4 CUSTOMERS WHO WERE DISTRIBUTED SIX EYEPIECES (10 TOTAL) IN THE PRODUCTION BATCH AND REPLACED THE EYEPIECES.
DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE INSTRUMENT WOULD NOT OPEN AFTER RELOADING. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS STATED THE THE DEVICE WAS OUTSIDE THE PT'S CAVITY WHEN THE DIFFICULTY WAS EXPERIENCED. NO PT INJURY OCCURRED.
BLOOD NOTED IN TUBING OF CATHETER AFTER AN UNDETERMINE AMOUNT OF TIME SURGICAL REMOVAL PERFORMED DUE TO BLOOD CLOT PRESENT IN BALLOON. THE HOSP WAS UNABLE TO PROVIDE ANY ADD'L INFO.
H-11 ALL UNK INFO REQUESTED BUT NOT RECEIVED. H-11 SECTION INFO PROVIDED BY THE MFR. H-11 SECTION F10 DEVICE CODE 1157 LABEL. H-10-NO CAT# AND LOT# AVAILABLE ALL APPROPIATE SPACES CANNOT BE FILLED.
AFTER AN ENDOSCOPE EYEPIECE FILTER ASSEMBLY WAS SOAKED FOR DISINFECTION IN 70% ISOPROPYL ALCOHOL, THE OPTICAL FILTER WAS NOTED TO HAVE FALLEN OUT OF HOLDER. THERE WAS NO INJURY INVOLVED IN THE INCIDENT. USE OF THE ENDOSCOPE WITHOUT THE FILTER MAY EXPOSE THE CLINICIAN TO A LEVEL OF ENERGY HIGHER THAN CDRH STD 1040.10 MPE OF .2 UJ. IT COULD POSSIBLY REACH A LEVEL OF 4.3UJ.
ONE BATCH OF EYEPIECES WAS FOUND TO HAVE BEEN PRODUCED WITH AN INSUFFICIENT AMOUNT OF EPOXY TO RELIABLY HOLD LENS IN PLACE. THE CAUSE OF THIS PROBLEM WAS TRACED TO THE WAY THE EPOXYING INSTRUCTIONS WERE INTERPETED BY AN ASSEMBLE UNFAMILIAR WITH THE PROCESS. THE PRINTS WERE CLARIFIED AND A FUNCTIONAL TEST ADDED TO THE PROCESS. WE NOTIFIED THE 4 CUSTOMERS WHO WERE DISTRIBUTED SIX EYEPIECES (10 TOTAL) IN THE PRODUCTION BATCH AND REPLACED THE EYEPIECES.
DURING SERVICE OF PRODUCT AN INTERMITTENT NO ALARM CONDITION WAS FOUND DUE TO RESISTORS R35 AND R36 ON THE LOGIC BOARD BEING OUT OF SPECIFICATION. REPLACED R35 AND R36.
A REVISION SURGERY WAS PERFORMED TO REPLACE THE ARTICULATING SURFACE DUE TO DELAMINATION.
DURING A SIGMOID COLECTOMY PROCEDURE, THE INSTRUMENT WAS DIFFICULT TO REMOVE FROM THE APPLICATION SITE. THE SURGEON MANUALLY MANIPULATED THE DEVICE OFF THE TISSUE AND COMPLETED THE PROCEDURE WITH ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
REPORT OF ALLEGED UNIT MAKING GRINDING NOISE, HEAR MOTOR BUT DOES NOT CYCLE FOUND DURING BENCH TEST. NO FURTHER INFO.
UNABLE TO OBTAIN ALL INFO REQUIRED INSECTION F. 100 ADD'L TESTING ONGOING TO DETERMINE CAUSE OF REPORTED FAILURE. 68 ADD'L TESTING ONGOING TO DETERMINE CAUSE OF REPORTED FAILURE. LABELING- 1738. H3 EVAL SUMMARY: TESTING BYI MFR FOUND MOTOR CYCLED, NO VOLUME DELIVERED, WITH AUDIBLE AND VISUAL ALARMS.
MFR RECEIVED DEVICE ON 7/17/96 BECAUSE OF THE GEAR BOX LEAKING OIL AND ALSO A REQUEST TO DO PREVENTATIVE MAINTENANCE AND RECERTIFICATION OF THE DEVICE. MFR SERVICED THE DEVICE AND RETURNED IT TO THE CUSTOMER ON 8/15/96. ON 9/16/96 MFR RECEIVED A COPY OF A MEDWATCH REPORT FROM THE FDA. THE REPORT REFERENCED AN ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. MFR CONTACTED REPORT SOURCE TO ASK ABOUT EVENT. REPORT SOURCE STATED THAT PT INDICATED HE WAS NOT GETTING ENOUGH AIR/SHORTNESS OF BREATH. PT WAS TAKEN OFF DEVICE AND PLACED ON ANOTHER DEVICE. SETTINGS AND MEDICATION CHANGES WERE MADE ON SECOND DEVICE AND PT DID NOT SUFFER PERMANENT IMPAIRMENT. NO ATTEMPTS WERE MADE TO CHANGE SETTINGS ON INITIAL DEVICE.
DURING THE CLOSURE OF A COLOSTOMY. THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/17/96-MEDWATCH REPORTED NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
REPORT OF ALLEGED "UNIT DOES NOT CYCLE, LEDS FLASH EVERY 10 SECONDS WITH AUDIBLE ALARM. NOT IN PT USE."
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F. LABELING-#1738. TESTING BY MFR FOUND A CONTINUOUS CYCLE, NO VOLUME DELIVERED, WITH AUDIBLE AND VISUAL ALARMS, DUE TO 1ST STAGE GEAR BEING OUT OF SPECIFICATION. REPLACED 1ST STAGE GEAR.
THE REPORTER INDICATED THAT AT IMPLANT, ATRIAL SENSING COULD NOT BE OBTAINED EVEN WHEN USING AA1. THE DEVICE WAS NOT IMPLANTED. IT SHOULD BE NOTED THAT THE CUT ON THE LEAD BODY WAS MADE BY THE DOCTOR WHEN EXTRACTING THE LEAD. THE DOCTOR DECIDED TO USE A DUAL CHAMBER SYSTEM.
REFERENCE SECTION F10 OF THIS FORM FOR THE EVENT PROBLEM CODES.
THE SAMPLE WAS DISCARDED BY THE HOSP, THEREFORE, THE ROOT CAUSE FOR THE SEPARATION COULD NOT BE DETERMINED.
DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE, THE KNIFE BLADE DID NOT RETRACT AFTER INSERTION. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. THE SURGEON COMPLETED THE PROCEDURE WITH THE SLEEVE.
10/17/96-MEDWATCH REORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE REPORTER INDICATED THAT A CURRENT OF .07 -0.8 MA AND A LEAD IMPEDANCE OF 7000 OHMS OR HIGHER ARE DISPLAYED WITHOUT CONNECTING THE PSC CABLE.
EVALUATION SUMMARY: THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING AND A COMPLETE VISUAL INSPECTION. NORMAL OPERATION WAS OBSERVED.
DURING SERVICE OF PRODUCR AN INTERMITTENT APNEA ALARM WAS FOUND DUE TO TRANSFORMER T1 ON THE PROCESSOR BOARD BEING OUT OF SPECIFICATION. REPLACED T1.
THE REPORTER INDICATED THAT WHEN TURNING THE DIAL KNOB, THE RATE CONNOT BE CHANGED. THE UNIT WILL BE RETUNED FOR REPAIR.
REPORT OF ALLEGED "NO LOW PRESSURE ALARM. FOUND DURING CHECKOUT PROCEDURE."
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F. LABELING-#1738. TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL.
GUIDEWIRE FRACTURED IN VIVO. TOTAL SEPARATION. NO SURGICAL INTERVENTION WAS REQUIRED. THE LINE REVEALED LESONS IN BOTH THE LAD AND RAMUS CORONARY ARTERIES WITH THE RAMUS BRANCH BEING ALMOST EQUAL IN SIZE TO THE LAD. TWO STENTS WERE PLACED IN THE LAD USING HIGH PRESSURE INFLATIONS; GOOD RESULTS WERE OBTAINED WITH NO DIFFICULTY NOTED WITH THE STABILIZER THAT HAD BEEN INSERTED INITIALLY. THE RAMUS BRANCH WAS THEN ENTERED, USING THE SAME STABILIZER, WHICH WAS PLACED VERY DISTAL. FOUR DIFFERENT 8 FRENCH GUIDING CATHETERS WERE INTRODUCED OVER THE WIRE WHILE IN THE RAMUS. THE LESION IN THE PROXIMAL PORTION OF THE VESSEL WAS DILATED AND A DISSECTION WAS OBSERVED. A STENT WAS PLACED AFTER WHICH A SECOND DISSECTION WAS NOTED JUST DISTAL TO THE STENT, BUT VERY PROXIMAL TO THE TIP OF THE GUIDEWIRE. A SECOND STENT WAS THEN INTRODUCED AND SUCCESSFULLY USED TO TACK THE MORE DISTAL DISSECTION WITH GOOD RESULTS. AT THE TIME THAT THE SECOND DISSECTION WAS OBSERVED, THE WIRE ASSUMED A KINKED-LIKE APPEARANCE ("L" SHAPED) VERY DISTAL TO THE DISSECTED AREA OF THE VESSEL. THIS WAS APPROX. FOUR HRS INTO THE CASE. NO VISIBLE FRACTURE OR SEPARATION WAS OBSERVED ON LINE. THE CASE WAS COMPLETED, AND WHEN THE WIRE WAS WITHDRAWN, THE TIP WAS STILL NOTED TO BE IN THE VERY DISTAL PORTION OF THE RAMUS. THERE WAS NO REPORT OF FEELING ANY JERKING OR RESISTANCE WHEN THE WIRE WAS WITHDRAWN. THE LINE THAT WAS VIEWED PROVIDED NO INDICATION OF WHEN THE ACTUAL FRACTURE OCCURRED DURING THE CASE, BUT THE WIRE APPEARED TO BE INTACT UNTIL THE POINT OF FULL SEPARATION WAS NOTED. EXTENSIVE MANIPULATION OF DEVICES ON THE WIRE OCCURRED DURING THE FOUR PROCEDURE HOURS PRE WIRE FRACTURE. IT WAS ALSO INDICATED THAT THE WIRE WAS SUBJECTED TO PERFORMANCE REQUIREMENTS WELL IN EXCESS OF WHAT IS USUAL AND CUSTOMARY.
THE TIP WAS RETRIEVED VIA A SNARE WITH NO FURTHER CLINICAL SEQUELAE REPORTED. THE PT'S CONDITION WAS INDICATED AS GOOD WITH AN UNCOMPLICATED POST CATH PERIOD. AN ON-SITE VISIT WITH DR WAS MADE BY WIRES CORE TEAM QUALITY ASSURANCE MANAGER, TO REVIEW THE LINE DISCUSS THE CASE IN DETAIL. THE FOLLOWING IS AN ACCOUNT OF THE INFO THAT WAS PROVIDED DURING THE VISIT. VISUAL EXAMINATION: UPON RECEIPT, THE GUIDEWIRE WAS NOTED TO BE FRACTURED AT THE DISTAL END. A SECTION OF THE BLACK PTFE SLEEVING EXTENDED 0.5 CM FROM THE FRACTURE SURFACE AND APPEARED STRETCHED AND FLATTENED. THE DISTAL FRACTURED WIRE SEGMENT WAS NOT RETURNED FOR EXAMINATION. THE APPROX. LOCATION OF THE FRACTURE WAS IMMEDIATELY PROXIMAL TO THE FLEX JOINT, IMMEDIATELY PROXIMAL TO THE PROXIMAL END OF THE FLATTENED COILWIRE. MICROSCOPIC EXAMINATION: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY REVEALED THE PRESENCE OF TEARS IN THE FRACTURE SURFACE DUE TO A TENSILE OVERLOAD COMBINED WITH A BENDING MOMENT, THAT FORM A SERIES OF PARALLEL KNIFE EDGES. ALTHOUGH THE EXACT CAUSE FOR THE FRACTURE COULD NOT BE DETERMINED, IT IS BELIEVED THAT THE TENSILE STRENGTH OF THE WIRE WAS EXCEEDED BY MULTIPLE CYCLES OF AN ACUTE BEND TO PRODUCE A DUCTILE FORCE FRACTURE. THERE WAS NO INDICATION OF TORQUE. A REVIEW OF THE PRODUCT HISTORY REVEALED THAT THIS IS THE FIRST REPORT OF THIS TYPE FOR THIS PRODUCT, COMPARED TO APPROX. 150,000 UNITS SHIPPED WORLD-WIDE.
THE REPORTER INDICATED THAT THE DEVICE DISPLAYED AN INTERMITTENT LOSS OF ATRIAL SENSING. ALSO, THE ATRIAL OUTPUT IS INTERMITTENTLY CAPTURING THE VENTRICLE.
REF SECTION F10 OF THIS FORM FOR THE EVENT PROBLEM CODES.
REPORT OF ALLEGED "NO HEART RATE SLOW ALARM. FOUND DURING BENCH TEST".
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F. LABELING-#1738. TESTING BY MFR FOUND A NO HEART RATE SLOW ALARM CONDITION AT POWER DUE TO RESISTOR R24 ON THE ANALOG BOARD BEING OUT OF SPECIFICATION. REPLACED R24.
SENSE PACE LEAD ADAPTER WAS BROKEN AND EXPLANTED ON 10/4/93.
THE REPORTER INDICATED THAT INTERMITTENT LOSS OF ATRIAL SENSING WAS DISPLAYED.
BLOOD WAS NOTED IN THE BALLOON TUBING AFTER AN UNDETERMINED AMOUNT OF TIME. NO COMPLICATION TO PT. ADD'L INFORMATION NOT AVAILABLE FROM USER.
H-11 ALL UNK INFO REQUESTED BUT NOT REC. H-11-SECTION F PROVIDED BY MFG. H-11-SECTION F10 DEVICE CODE 1746 LABEL.
THE REPORTER INDICATED THAT THE DEVICE WAS EXHIBITING INTERMITTENT VENTICULAR UNDERSENSING. ONE INTERVAL SEEMED TO BE SHORTER THAT THE LOWER RATE.
WITH A PT ON THE TABLE ANESTHETIZED AND INTUBATED, THE TABLE EXPERIENCED A "SUDDEN" VERTICAL DROP OF 2-3". PT HAD TO BE REINTUBATED. PT NOT INJURED.
WITH A PT ON THE TABLE ANESTHETIZED AND INTUBATED, THE TABLE EXPERIENCED A "SUDDEN" VERTICAL DROP OF 2"-3". PT HAD TO BE RE-INTUBATED. PT NOT INJURED. TECH HAS BEEN IN TO INSPECT THE TABLE. NO PROBLEM WITH THE TABLE WAS FOUND, SERVICE TECHNICIAN COULD NOT DUPLICATE PROBLEM. TABLE HAS BEEN PLACED BACK INTO SERVICE AT THE FACILITY. CONSTRUCTION OF THE TABLE DOES NOT PERMIT A "SUDDEN" VERTICAL DROP. THE HYDRAULIC SYSTEM STAGE BLOCK WAS CHECKED TO DETERMINE IF AIR WAS IN THE LINES, TECH CHECKED TABLE BASE, THERE WAS NOTHING TO INDICATE A LEAK THAT WOULD ALLOW AIR INTO THE STAGE BLOCK. RAM SEAL WAS CHECKED BY OPENING UP THE BLEED SCREW, TECH GOT A COUPLE OF SMALL AIR BUBBLES OUT, BUT NOT OF A MAGNITUDE THAT COULD CAUSE A "SUDDEN" DROP. TECH HAS PERFOEMED AN ON SITE EVALUATION, TABLE WAS CHECKED FOR TRAVEL, LEAKS OR LOOSE CONNECTIONS. TABLE MOVEMENT AND ARTICULATION WAS ALSO TESTED. NO PROBLEMS WAS FOUND WITH TABLE. ALL TESTS AND CHECKS SHOW THE TABLE TO BE WORKING WITHIN SPECIFICATIONS. TECH WAS ASKED TO ATTEMPT TO FIND OUT IF A FOOT CONTROL WAS IN USE, WHEN HE INSPECTED THE TABLE, NO FOOT CONTROL WAS EVIDENT. IF FOOT CONTROL WAS BEING USED AT THE TIME OF THE EVENT, IT IS POSSIBLE IT MAY HAVE BEEN INADVERTENTLY ACTIVATED, CAUSING THE DOWNWARD MOVEMENT OF THE TABLE. PERSONNEL AT THE ACCOUNT DO NOT RECALL INADVERTENTLY ACTIVATING THE CONTROLS. TABLE IS MAINTAINED BY IN-HOUSE PERSONNEL. UNLESS ADD'L PERTINENT INFO ARISES CO PLANS TO TAKE NO FURTHER ACTION AND CONSIDERS THIS CLOSED.
BIPOLAR LEAD WAS EXPLANTED DUE TO "POSSIBLE LEAD FRACTURE." DURING AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE THE PHYSICIAN ELECTED TO REPLACE THIS LEAD WITH A NEW BIPOLAR LEAD.
WHILE FLUSHING THE HANDPIECE PRIOR TO USE THE CUSTOMER REPORTEDLY OBSERVED METAL PARTICLES FLOWING OUT THE TIP. THERE WAS NO PT INVOLVEMENT WITH THIS EVENT.
ALL THE INFO IN BLOCK F WAS COMPLETED BY THE MFR. PLEASE NOT THAT UNDER SECTION F10, PT CODE, THERE WAS NO PT INVOLVEMENT WITH THIS EVENT.
THE REPORTER INDICATED THAT THE DEVICE IS EXHIBITING INTERMITTENT OVERSENSING.
THE REPORTER INDICATED THAT THE DEVICE EXHIBITED INTERMITTENT LOSS OF VENTRICULAR SENSING.
A 76 YR OLD MALE PT WAS IN A CODE SITUATION. THE PT WAS ATTACHED TO THE UNIT VIA A MULTI-FUNCTION CABLE AND MULTI-FUNCTION ELECTRODES. THE STAFF CHARGED THE UNTI TO 200J, BUIT IT WOULD NOT DISCHARGE. STAFF INDICATED THAT THE 200J MESSAGE REMAINED ON THE UNIT'S MONITOR SCREEN AND THE UNIT DID NOT PRINT A STRIP. THE STAFF VERIFIED THAT THE UNIT WAS NOT IN SYNCH MODE. THEY CHARGED THE UNIT TO 200J A SECOND TIME AND DEFIBRILLATED THE PT. THE PT'S RHYTHM WAS CONVERTED AND THERE WAS NO ADVERSE EFFECT ON THE PT. THE FACILITY'S BIOMEDICAL ENGINEERING DEPT EVALUATED THE UNIT AND FOUND IT TO BE FUNCTIONING PROPERLY. THE UNIT WAS RETURNED TO SERVICE.
DEVICE WAS SENT IN FOR REPAIR. DEVICE WAS RETURNED WITH BROKEN LOWER JAW AND ACTUATOR.
DEVICE REPORTED TO HAVE BROKEN IN SURGERY WHEN SURGEON WAS SAID TO HAVE USED EXCESSIVE FORCE IN ATTEMPTING TO TAKE A "LARGE BITE." NO PT INJURY WAS REPORTED. DEVICE WAS 8 YEARS OLD AND JAWS WERE DULL AND WORN. CO DISCLAIMER: "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS COMPLOYEES CAUSED OR CONTRIBURTED TO THE EVENT DESCRIBED IN THIS REPORT."
DRILL VIBRATES TOO HIGH. IT KEEPS BREAKING THE TIPS DURING USE.
TESTING COULD NOT DUPLICATE THE STATED COMPLAINT. INSPECTION OF ALL COMPONENTS DID NOT REVEAL ANY CORROSION OR WEAR THAT COULD HAVE CAUSED THE ABOVE COMPLAINT. BUR DAMAGED TO THE POINT WHERE IT COULD NOT BE RECOGNIZED OR IDENTIFIED.
THE SVC REPORT SHOWS WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE DEVICE THE SVC TECH VERIFIED THE DEVICE DID NOT PASS THE PRESSURE LEAK TESING. THE ST INSPECTED THE DEVICE AND ADJUSTED THE SAFETY PRESSURE DUMP SPRING. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION. IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
DURING SERVICE OF DEVICE A MOTOR STALL, WITH AUDIBLE LOW PRESSURE ALARM, WAS FOUND DUE TO TRANSISTORS Q9 AND Q12 ON THE MOTOR BOARD BEING OUT OF SPECIFICATION. REPLACED Q9 AND Q12.
THE REPORTER INDICATED THAT THE DEVICE HAD REACHED END OF SERVICE.
REFERENCE F10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE REPORTED EOS WAS THE RESULT OF LOW MODULE VOLTAGE DUE TO BATTERY DISCHARGE. THE BATTERY IS EXPIRED NORMAL THE OBSERVED "NO COMMS" WAS DUE TO A DISLODGED COMPONENT, C-25 IN THE TELEMETRY CIRCUITRY. THE CAUSE WAS NOT ASCERTAINED.
A BLADDER NECK SUSPENSION PROCEDURE WAS PERFORMED WITHOUT INCIDENT. THE PT RETURNED WITH INCONTINENCE. A CT PERFORMED REVEALED AN ANCHOR HAD DISLODGED AND WAS FREE FLOATING, NO SIGNS OF INFECTION WERE NOTED. THE ANCHOR WAS NOT REMOVED AND ANOTHER ANCHOR WAS IMPLANTED AT THAT TIME. THE PT'S CONDITION IS GOOD. THE DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. WITHOUT FURTHER DETAILS, CO IS UNABLE TO DETERMINE THE CAUSE FOR THIS EVENT.
END USER HOSP REPORTED THAT DURING AN INJECTION WITH A 10CC. SYRINGE, THE SYRINGE CRACKED, LEAKING/SPRAYING BLOOD. THERE WAS NO PT INJURY.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED. ANALYSIS SHOWS THAT THIS CALIBRATION CODE, IF USED TO PERFORM AN ASSAY WITH TEST STRIPS FROM ANY LOT, COULD RESULT IN HIGHER THAN EXPECTED VALUES. NO INJURIES REPORTED IN THE FIELD.
ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT# T 741) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPECIFICATION.
SYNTHES IS SUBMITTING THIS REPORT PERSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFO WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR IT'S EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEED CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.
THE CUSTOMER STATED THAT THE DEVICE HAD NO AUBIBLE ALARM OR BEEP WHEN DEPRESSING THE PARAMETER KEYS. THE CSE INSPECTED THE DEVICE AND REPLACED THE POWER SWITCH AS A PRECAUTIONARY MEASURE. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE AUDIBLE ALARM DID NOT ACTIVATE, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
WHILE RUNNING A TPN, STATION #3 WAS PROGRAMMED FOR 1.52 ML BUT DELIVERED 1.62 ML. ALL OTHER STATIONS DELIVERED WHAT WAS PROGRAMMED. THERE WERE NO ALALRM CONDITIONS AND THE UNIT DID NOT EXPERIENCED ANY CALIBRATION PROBLEMS. THERE WAS NO PT INVOLVEMENT.
THE UNIT WAS DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
ON 10/1/96, CUSTOMER STATED THE FOLLOWING: DURING A CALL: (CUSTOMER WILL NOT GIVE ACTUAL CODE INFO ON PT.) PT WAS IN CARDIAC ARREST. UNIT HOOKED UP, PADS WOULD NOT PEEL APART. SEVERAL PAIRS WERE USED. PT TRANSPORTED TO A HOSP AND PRONOUNCED. DISTRIBUTOR TRIED CALLING BACK ON 9/17/96. CUSTOMER DID NOT RETURNED CALL. 10/1/96, DISTRIBUTOR CALLED AGAIN AND GOT THIS INFO.
THE DEVICE WAS APPLIED DURING A PROSTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE CONSISTENTLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HSP HAS REPORTED THAT NO PT INJURY OCCURRED. EXPIRATION DATE: 7/31/2001.
10/18/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL RWEPORT TO FDA BY MFG.
THE CUSTOMER ALLEGED THE DEVICE HAD AN INTERMITTENT AUDIBLE ALARM. THE CSE INSPECTED THE DEVICE AND REPLACED THE AUDIO ALARM ASSEMBLY AS A PRECAUTIONARY MEAUSRE. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE ALARM WAS INTERMITTENT, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
PHYSICIAN WAS JUST BEGINNING TO USE DISLODGER - HAD IT AT LOWER PART OF URETER AND WENT TO OPEN (OR CLOSE) THE WIRE BASKET WHEN THE PLASTIC SPLIT. PROCEDURE WAS STOPPED. NO HARM TO PT.
ROUTINE COMPLAINTS INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BENG OBTAINED. ANALYSIS SHOWS THAT THIS CALIBRATION CODE, IF USED TO PERFORM AN ASSAY WITH TEST STRIPS FROM ANY LOT, COULD RESULT IN HIGHER THAN EXPECTED VALUES. NO INJURIES REPORTED IN THE FIELD.
ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT# P682) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY QUESTION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPECIFICATION.
THE SVC REPORT SHOWS WHILE PERFORMING SVC ON THE UNIT THE CSE VERIFIED THE DEVICE AUDIO ALARM DID NOT ACTIVATE. THE CSE INSPECTED THE DEVICE AND REPLACED THE ALARM PRESSURE SWITCH. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION PROCEDURE. THE SURGEON STATED THE STAPLE LINE WAS COMPLETE, HOWEVER, BLEEDING WAS OBSERVED. HE OVERSEWED THE APPLICATION SITE TO CORRECT THE CONDITION. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. EXPIRATION DATE: 7/31/2001.
THE UNIT WAS OVERDELIVERED BY 90 ML ON STATION #2 BEFORE AN ALARM WAS SET. THE USER DID NOT KNOW WHAT ALARM WAS AET WHEN IT OVERDELIVERED BY 90 ML. THERE WAS NO PT INVOLVEMENT. THE UNIT WAS SWAPPED OUT.
SECTION F COMPLETED BASED ON INFO RECEIVED FROM THE REPORTER. EVALUATION: THE UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMEANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT# S911) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPECIFICATION.
THE REPORTED INDICATED A SUSPECTED MALFUNCTION AND REPAIR. THERE WAS NO PT INVOLVEMENT.
REF F10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE HIGH LEAD IMPEDANCE AND HIGH AMPLITUDE READINGS WERE THE RESULT OF A MALFUNCTIONING ANALOG SWITCH, A3 ON THE PRINTED CIRCUIT BOARD "C".
THE SVC REPORT SHOWS THAT THERE WAS NO AUDIO ALARM. THE CSE VERIFIED THAT THE AUDIO ALARM WORKS INTERMITTENTLY. THE CSE INSPECTED THE DEVICE AND REPLACED THE ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE KNIFE BLADE WOULD NOT RETRACT UPON ENTRY. THE SURGEON REMOVED THE OBTURATOR AND COMPLETED THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. EXPIRATION DATE: 6/30/2001.
THE REPORTER RETURNED THE DEVICE BECAUSE OF A STERILITY VIOLATION. THERE WAS NO PT INVOLVEMENT.
REFERENCE F10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE OBSERVED "NO COMMS" WAS THE RESULT OF A FRACTURED CRYSTAL IN THE OSCILLATOR CIRCUIT. THE CAUSE OF THE FRACTURE WAS NOT ASCERTAINED.
THE UNIT HAS BEEN GOING INTO NO FLOW ALARMS ON STATION #9 DURING THE FILL CYCLE. FOR EXAMPLE, STATION #9 WAS PROGRAMMED FOR 1.97 ML AND AT 1.72 ML IT WENT INTO A NO FLOW. THE USER HAD TO PRESS THE START BUTTON SEVERAL TIMES TO GET THE VOLUME UP TO 1.94 ML. ALSO, A BAG OF SOLUTIONS COMPOUNDED ON THE UNIT APPEARED CLOUDY. THERE WAS NO PT INVOLVEMENT, BAG WAS NOT ADMINISTERED.
SECTION F COMPLETED BY CO BASED ON INFO RECEIVED FROM THE REPORTER. EVALUATION: THE UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
ROUTINE COMPLAINTS INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED. ANALYSIS SHOWS THAT THIS CALIBRATION CODE, IF USED TO PERFORM AN ASSAY WITH TEST STRIPS FROM ANY LOT, COULD RESULT IN HIGHER THAN EXPECTED VALUES. NO INJURIES IN THE FIELD.
ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT# S581) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TIME OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPECIFICATION.
ELDERLY PT WAS HAVING A BARIUM SWALLOW AND HE WAS PLACED INTO THE FLUORO CHAIR BY THE RADIOLOGIC TECH. THE TECH SECURED THE EQUIPMENT AND THEN PLACED THE PT IN THE FLUORO CHAIR FOR THE PROCEDURE. PT WAS SECURELY STRAPPED IN THE CHAIR. AS THE TABLE WAS BEING MOVED TO THE UPRIGHT POSITION THE CHAIR BEGAN TO SLIDE FORWARD. THE TECH CAUGHT THE PT AND WAS ASSISTED BY THE SPEECH PATHOLOGIST WHO WAS IN THE ROOM. THE CHAIR AND THE FOOTBOARD WERE IMMEDIATELY EXAMINED BY A CLINICAL ENGINEERING TECH AND A SVC TECH. IT WAS DETERMINED THAT THE CHAIR HAD SOMEHOW BEEN MOVED OUT OF THE PROPER POSITION AND THEN UNLOCKED THE FOOTBOARD INTERLOCKS TO THE RADIOLOGY TABLE. THIS CAUSED THE CHAIR AND FOOTBOARD TO SLIDE. THE MFR WAS NOTIFIED AND RPTR WAS INSTRUCTED THAT THEY NO LONGER CARRIED PARTS FOR THIS TYPE OF CHAIR. SINCE A LOCK WAS BENT ON THE CHAIR RPTR THEN REFERRED TO A CO FOR REPLACEMENT PARTS FOR THE CHAIR. THE CHAIR WAS REPAIRED BY THE CLINICAL ENGINEERING DEPT AND PLACED BACK IN SVC. PRIOR TO PUTTING BACK INTO SVC THE RADIOLOGY DEPT WAS INSERVICED ON TAKING PRECAUTIONS TO AVERT ANY SIMILAR TYPE OCCURRENCES WITH WHAT MAY BE A DESIGN DEFECT IN THAT CHAIR.
THE DEVICE WAS APPLIED DURING A LOBECTOMY PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON MANUALLY MANIPULATED THE DEVICE OPEN WITHOUT INCIDENT. EXPIRATION DATE: 8/31/2001.
COMPLAINANT STATES THAT THE METAL PLUG COMPONENT OF THE ACETABULM PROSTHESIS WOULD NOT ASSEMBLE CORRECTLY. SURGERY WAS PROLONGED (MINIMALLY) AS A RESULT OF THIS EVENT. NO INJURY TO THE PT WAS REPORTED TO CO.
THE USER REPORTED NO FLOW PROBLEMS, FIRST OCCURRED ON STATION #8 WITH MVI, SPIKE WAS CHANGED OUT AND THAT RESOLVED THE PROBLEM, THEN IT HAPPENED ON STATION #4 WITH KPHOS WHICH COULD NOT BE RESOLVED WITH TROUBLE SHOOTING. THE UNIT WAS SWAPPED OUT. THERE WAS NO PT INVOLVEMENT.
SECTION F COMPLETED BY CO BASED ON INFO RECEIVED FROM THE REPORTER. EVALUATION: THE UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLLAINT COULD NOT BE DUPLICATED.
A BALLOON DEVELOPED A PIN-HOLE LEAK ON THE SECOND INFLATON AT EIGHT ATMOSPHERES DURING A PERIPHERAL ANGIOPLASTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION REVEALED A PIN-HOLE LEAK OVER THE DISTAL RO MARKER. MICROSCOPIC EXAMINATION ALSO REVEALED CHATTER MARKS ON THE BALLOON SURFACE. DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP EXTERNAL SOURCE, CHATTER MARKS ON THE BALLOON SURFACE. CO'S FOLLOW UP ALSO INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION. CO BELIEVES THESE FACTORS CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE.
A BALLOON DEVELOPED A PIN-HOLE LEAK ON THE SECONDE INFALTION AT 8 ATMOSPHERES DURING A PERIPHERAL ANGIOPALSTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE, WITHOUT PT COMLICATIONS. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINIEERING EVAL REVEALED A PIN-HOLE LEAK OVER THE DISTAL RO MARKER. MICROSCOPIC EXAMINATION ALSO REVEALED CHATTER MARKS ON THE BALLOON SURFACE. DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP EXTERNAL SOURCE, CHATTER MARKS ON THE BALLOON SURFACE. CO'S FOLLOW UP ALSO INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION. CO BELIEVES THESE FACTORS CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE.
PT CARDIAC MONITOR TONES WERE NOT AUDIBLE. TONE DIAL TURNED DOWN. PT WENT INTO CARDIAC ARREST WITHOUT STAFF KNOWING IT. PT DIED. BIOMED DEPT HAS NOW FIXED ALL MONITOR DIALS IN THE HIGH TONE POSITION.
THE DEVICE WAS APPLIED DURING AN END-TO-END ANASTOMOSIS. THE STAPLES DID NOT FORM PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. EXPIRATION DATE: 5/31/1999.
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9 AND F8. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN A3.
REPORTEDLY, TWO FREEZING CONTAINERS WERE FOUND RUPTURED AFTER TRANSPORTATION FROM ANOTHER FACILITY. THE CONTENTS OF THE CONTAINER, PERIPHERAL BLOOD STEM CELLS, WERE DISPOSED OF AT THE TIME OF THE EVENTS. THE PT WAS NOT IMPACTED BY THE EVENT. SUFFICIENT BACK UP CELLS REMAINED TO TRANSPLANT THE PT. THE CONTAINERS WILL NOT BE RETURNED FOR EVAL. THE CONTAINERS, AFTER REMOVAL FROM THE LIQUID NITROGEN STORAGE TANK ARE EXTREMELY FRAGILE IN THIS FROZEN STATE. CARE MUST BE TAKEN WHEN HANDLING OR TRANSPORTING THE FROZEN PRODUCT NOT CAUSE ANY MECHANICAL DAMAGE TO THE PLASTIC CONTINER. SMALL CRACKS OR FRACTURES IN THE BODY OF THE CONTAINER MAY CAUSE THE INGRESS OF LIQUID NITROGEN AND CASUE THE RUPTURE OR DISTENTION OF THE CONTAINERS. FREEZING AND THAWING RECOMMENDATIONS ARE DISTRIBUTED WITH EACH MODEL NUMBER SOLD.
BAXTER HEALTHCARE CORP ("BAXTER") SUBMITS THE FOLOWING REPORT, TOGETHER WITH ANY TELEPHONE OR WRITTEN REPORTS ON THE SAME INCIDENT, TO THE FDA PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THESE REPORTS ARE BASED ON INFO REC'D BY BAXTER WHICH BAXTER MAY NOT HAVE HAD ANY OPPORTUNITY TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THESE REPORTS SHALL NOT BE CONSTRUED AS AN ADMISSION BY BAXTER THAT THE PRODUCT(S), DESCRIBED HEREIN, ARE PRODUCTS OF ITS MFR AND ARE OR WERE DEFECTIVE OR DANGEROUS PRODUCTS IN ANY RESPECT, OR THAT ANY CASUAL RELATIONSHIP EXISTS BETWEEN THESE PRODUCTS AND ANY ACTUAL OR POTENTIAL INJURY. IN ADDITION, THE SUBMISSION OF A REPORT BY BAXTER SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED.
THE DEVICE, WHICH IS ON THE SAFETY ALERT, WAS EXPLANTED BECAUSE THE BATTERY OUTPUT OCCASIONALLY FAILS ABRUPTLY.
A BALLOON DEVELOPED A PIN-HOLE LEAK ON THE FIRST INFLATION DURING AN ILIAC ANGIOPLASTY. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE SHAFT UNDER THE BALLOON WAS BOWED. MICROSCOPIC EXAMINATION REVEALED A PIN-HOLE LEAK 12MM PROXIMAL TO THE DISTAL RO MARKER. SCRATCHES WERE NOTED ON THE BALLOON SURFACE. DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH OVER-PRESSURIZATION, A BOWED SHAFT UNDER THE BALLOON, AND CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES ON THE BALLOON SURFACE. THEREFORE, CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE.
A BALLOON DEVELOPED A PIN-HOLE LEAK ON THE FIRST INFLATION DURING AN ILIAC ANGIOPLASTY. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFUILLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE SHAFT UNDER THE BALLOON WAS BOWED. MICROSCOPIC EXAM REVEALED A PIN-HOLE LEAK 12MM PROXIMAL TO THE DISTAL RO MARKER. SCRATCHES WERE NOTED ON THE BALLOON SURFACE. DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH OVER-PRESSURIZATION, A BOWED SHAFT UNDER THE BALLOON, AND CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES ON THE BALLOON SURFACE. THEREFORE, CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. A COMPONENT DISENGAGED INTO THE PT'S CAVITY. THE COMPONENT WAS RETRIEVED WITHOUT INCIDENT. EXPIRATION DATE: 1/31/2001.
WE COULD NOT RELIABLY DETERMINE THE EXACT CAUSE OF THE DIFFICULTY REPORTED OR THE DAMAGE OBSERVED AS A PORTION OF THE DEVICE WAS NOT RETURNED FOR EVALUATION.
COMPLAINANT STATES THAT THE METAL PLUG COMPONENT OF THE ACETABULM PROSTHESIS WOULD NOT ASSEMBLE PROPERLY. SURGERY WAS DELAYED AS A RESULT, HOWEVER, NO INJURY TO THE PT WAS REPORTED. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. D1-METAL SHELL COMPONENT OF THE ACETABULUM PROSTHESIS WAS ALSO INCLUDED IN THE DEVICE EXPERIENCE REPORT, HOWEVER IT IS NOT CONSIDERED TO HAVE BEEN THE CAUSE OF THE ALLEGED PROBLEM. (C/N 1246-02-000; MFR L/N 885090.
THE DEVICE HAD AN INTERMITTENT LOSS OF ATRIAL SENSING.
REPORTEDLY, DURING THE FINAL FILTRATION INTO THE STORAGE CONTAINER, THE CREAM COLORED CONNECTOR BELOW THE CLAMP SEPARATED FROM THE TUBING. APPROX THE LAST 50CC'S OF BONE MARROW CELLS WERE LOST. THE PT WAS NOT ADVERSELY EFFECTED BY THE EVENT. SUFFICIENT BONE MARROW HAD ALREADY BEEN CAPTURED FOR THE PT. THE PRODUCT WILL BE RETURNED FOR EVAL. AT THE TIME OF THIS REPORT THE PRODUCT HAS NOT BEEN REC'D FOR EVAL.
CO SUBMITS THE FOLLOWING REPORT, TOGETHER WITH ANY TELEPHONE OR WRITTEN REPORTS ON THE SAME INCIDENT, TO THE FDA PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THESE REPORTS ARE BASED ON INFO REC'D BY CO WHICH CO MAY NOT MAY HAVE ANY OPPORTUNITY TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THESE REPORTS SHALL NOT BE CONSTRUED AS AN ADMISSION BY BAXTER THAT THE PRODUCTS, DESCRIBED HEREIN, ARE PRODUCTS OF ITS MFR AND ARE OR WERE DEFECTIVE OR DANGEROUS PRODUCTS IN ANY RESPECT, OR THAT ANY CASUAL RELATIONSHIP EXISTS BETWEEN THESE PRODUCTS AND ANY ACTUAL OR POTENTIAL INJURY. IN ADDITION, THE SUBMISSION OF A REPORT BY BAXTER SHALL NOT BE CONSTRUCTED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED.
THE DEVICE WAS PROGRAMMED TO DDD, LR = 60, UR = 140, AVD =200/150. THE DEVICE IS PACING DUAL CHAMBER AT 60. AS THE MAGNET WAS APPLIED, THE PACING RATE FLUCTUATED FOR TWO CYCLES BEFORE THE TMT (THRESHOLD MARGIN TEST). THE TMT WAS FOLLOWED BY ASYNCHRONOUS PACING AT 70 (EVEN THOUGH THE DEVICE IS PROGRAMMED TO 60). LATER, THE DEVICE RETURNED TO NORMAL BEHAVIOR AND THE PT WAS SENT HOME.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC BOWEL RESECTION PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO REMOVE. THE SURGEON MANUALLY MANIPULATED THE DEVICE OFF THE TISSUE WITHOUT INCIDENT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. EXPIRATION DATE: 9/30/2000.
11/14/96-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
DURING A CATH LAB PROCEDURE, A 32 YEAR OLD MALE PT DEVELOPED V FIB. THE STAFF DEFIBRILLATED THE PT AT 200J AND AT 300J. THE STAFF IS UNSURE IF THE UNIT DISCHARGED PROPERLY. THE STAFF DEFIBRILLATED THE PT A SECOND TIME AT 300J AND HIS RHYTHM WAS CONVERTED. THERE WAS NO ADVERSE EFFECT ON THE PT. WHEN THE UNIT WAS UNPLUGGED FROM AC POWER, THE STAFF INDICATED THAT THE UNIT MADE A LOUD "POPPING" SOUND. THE COMPLAINANT ALSO INDICATED THAT THE UNIT'S RECORDER TIME WAS DIFFERENT THAN THE CLOCK IN THE CATH LAB.
AT IMPLANT, THE PHYSICIAN NOTICED RESIDUE AROUND THE TIP OF THE LEAD. THE DR PICLED OFF QUITE A BIT OF IT, CONFUSED AS TO WHETHER OR NOT THIS WAS THE PEG PART OF THE LEAD TIP. HE DECIDED TO IMPLANT A NEW LEAD. AGAIN RESIDUE WAS NOTICED AT THE TIP. THE DEVICE WILL BE RETURNED FOR ANALYSIS. A PT WAS NOT DIRECTLY INVOLVED IN THIS EVENT.
NO RESIDUE WAS NOTED ON THE LEAD TIP. CANNOT VERIFY THE COMPLAINT. EXCESS PEG COATING CAN BE FOUND PROXIMAL TO THE BULLET AFTER THE SHEATH IS REMOVED. THIS IS A NORMAL CONDITION. THE DEVICE IS WITHIN SPECIFICATION.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. PNEUMOPERITONEUM LEAKED FROM FROM THE DEVICE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. EXPIRATION DATE: 11/30/2000.
A BALLOON RUPTURED ON THE FIRST HAND INFLATION DURING A DIFFICULT RENAL ANGIOPLASTY OF A CALCIFIED LESION. A PRESSURE GAUGE WAS NOT UTILIZED. ANOTHER MFR'S BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS JUST RECEIVED BY THIS MFR. UPON COMPLETION OF THE ENGINEERING EVALUATION, A SUPPLEMENT WILL BE FORWARDED. IT WAS INDICATED THIS DEVICE WAS INFLATED WITHOUT THE BENEFIT OF A PRESSURE GAUGE AS WELL AS USED IN A TORTUOUS CALCIFIED LESION. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, UNTIL THE COMPLETION OF THE ENGINEERING EVALUATION, CO IS INABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT.
A BALLOON RUPTURED ON THE FIRST HAND INFLATION DURING A DIFFICULT RENAL ANGIOPLASTY OF A CALCIFIED LESION. A PRESSURE GAUGE WAS NOT UTILZIED. ANOTHER MFR'S BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS JUST RECEIVED BY THIS MFR. UPON COMPLETION OF THE ENGINEERING EVAL, A SUPPLEMENT WILL BE FORWARDED. IT WAS INDICATED THIS DEVICE WAS INFLATED WITHOUT THE BENEFIT OF A PRESSURE GAUGE AS WELL AS USED IN A TORTUOUS CALCIFIED LESION. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, UNTIL THE COMPLETION OF THE ENGINEERING EVAL, CO IS UNAABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT.
AT IMPLANT, THE PHYSICIAN NOTICED RESIDUE AROUND THE TIP OF THE LEAD. A PT WAS NOT DIRECTLY INVOLVED IN THIS EVENT.
REPORTEDLY, AFTER PERFORMING A ROUTINE TEST LOAD DISCHARGE TO AN ATTACHED PACING/DEFIBRILLATION ADAPTER, THE DEVICE COULD NOT BE TURNED OFF AND IT WOULD NOT RESPOND TO ACTUATION OF ANY FRONT PANEL SWITCH.
THE LOCAL FACTORY SERVICE REP OBSERVED THAT WHEN DEFIBRILLATOR CHARGE WAS INITIATED, THE CRT DISPLAYED A CHECKERBOARD PATTERN WHICH WAS SUPERIMPOSED OVER UPDATING ECG INFO, AND THE DEVICE SUBSEQUENTLY WOULD NOT SHUT OFF. THE DEVICE MAIN PCB ASSEMBLY WAS REPLACED IN AN UNSECCESSFUL ATTEMPT AT CORRECTION. THE REP THEN REPLACED THE DEVICE POWER CONVERSION PCB AND PROPER OPERATION WAS REPEATEDLY OBSERVED. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE. THE REPLACED ASSEMBLIES WERE EVALUATED BY THE FACTORY. A FACTORY EVAL OBSERVED FAILURE OF POWER SUPPLY PCB ASSEMBLY TRANSISTOR, Q15. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA. CODE # 1525- NOT LABELED.
AMBULATORY PT PUSHED POLE INTO BATHROOM WITH 3 DEVICES MOUNTED ON POLE. PUMP #3 FELL TO FLOOR. MEDICATION WAS SPILLED ONTO BATHROOM FLOOR. PT COMMENTED THAT THE PUMP HAD BRUSHED HER LEG WHEN IT FELL. SOME REDNESS AND LIGHT BRUISING WAS NOTED. NO INCIDENT RELATED MEDICAL INTERVENTION WAS NOTED.
THE NOTED CONDITION WAS A RESULT OF AN OUT OF TOLERANCE SIDE RAIL ON THE DEVICE ALONG WITH IMPROPER USE (REMOVING PUMPS FROM IV POLE WHILE STILL CONNECTED TOGETHER AND USING EXCESSIVE FORCE TO SEPARATE) BY HOSPITAL STAFF. CONDITION COULD RESULT IN A BENT CONNECTING ARM WHICH MAY NOT ENGAGE WHEN ATTACHING TO MOUNTED PUMP.
THE LEAD WAS REMOVED DUE TO A LEAD WIRE FRACTURE.
ANALYSIS SUMMARY: DRIED BLOOD WAS FOUND IN THE LUMEN NEAR THE CONNECTOR PIN. IT IS LIKELY THAT ATTEMPT TO FORCE THE STYLET PAS THIS BLOCKAGE STRETCHED THE INNER COIL AND CAUSED THE ANOMALIES NOTED AT IMPLANT. THE WIRE WAS NOT FRACTURED, ONLY STRECTHED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SLEEVE DISENGAGED. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. EXPIRATION DATE: 4/30/2001.
OVER THE COURSE OF A WEEK AND A HALF, A UNIT IN AN EP LAB DID NOT FUNCTION PROPERLY. THE FIRST TIME THE UNIT DID NOT FUNCTION PROPERLY, STAFF MEMBERS WERE ATTEMPTING TO DEFIBRILLATE A PT (AGE AND GENDER UNK) AT 200J AND THE UNIT DID NOT DISCHARGE. THE STAFF RECHARGED THE UNIT AND CONVERTED THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT. THE FACILITY'S BIOMEDICAL ENGINEERING DEPT EVALUATED THE UNIT AND FOUND IT TO BE FUNCTIONING PROPERLY. THEY FELT THAT THE ALLEGED MALFUNCTION WAS CAUSED BY CLINICIANS DEPRESSING THE DISCHARGE BUTTONS TOO QUICKLY. THE STAFF WAS RE-INSERVICED ON THE PRODUCT. THE UNIT WAS RETURNED TO SVC IN THE EP LAB. SOME TIME LATER, STAFF MEMBERS WERE TREATING A PT (AGE AND GENDER UNK). THE STAFF ATTEMPTED TO DEFIBRILLATE THE PT AT 200J, AND THE UNIT DID NOT DISCHARGE. THE STAFF RECHARGED THE UNIT AND CONVERTED THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT. THE FACILITY'S BIOMEDICAL ENGINEERING DEPT EVALUATED THE UNIT AND FOUND IT TO BE FUNCTIONING PROPERLY. THE UNIT WAS RETURNED TO SVC. A FEW DAYS LATER, THE ALLEGED MALFUNCTION OCCURRED A THIRD TIME. THE UNIT DID NOT DISCHARGE TWICE DURING AN EP LAB PROCEDURE. THE PT (AGE AND GENDER UNK) WAS CONVERTED AND THERE WAS NO ADVERSE EFFECT ON THE PT. THE COMPLAINANT INDICATED THAT OVER THE COURSE OF THE WEEK AND A HALF, THE UNIT DID FUNCTION PROPERLY DURING SEVERAL EP LAB PROCEDURES.
THE DR NOTED AN INCREASE IN LEAD IMPEDANCE. AT IMPLANT, THE IMPEDANCE WAS 500 OHMS, 6 MONTHS LATER, IT WAS 700 OHMS, AND TODAY IT WAS 1114 OHMS. THE DEVICE WAS PROGRAMMED TO THE UNIPOLAR CONFIGURATION. THE UNIPOLAR IMPEDANCE IS 538 OHMS. THE DEVICE IS WORKING FINE.
EMT'S ATTENDED TO A PT WITH AN INTRINSIC HEART RATE OF 30 BEATS PER MIN. PACING THERAPY WAS INITIATED AT A RATE OF 90 BPM WITH THE CURRENT SET AT 75 MA. RING TRANSPORT TO THE HOSP, ALLEGEDLY THE UNIT GAVE A LEADS OFF ALARM. THE OPERATOR REPORTEDLY CHECKED ALL APPROPRIATE CONNECTIONS AND COULD FIND NO REASON FOR THE ALARM. THE OPERATOR DECIDED TO ABORT PACING THERAPY AFTER CHECKING THE PT AND OBSERVING A SELF-SUSTAINED HEART RHYTHM. THE PT WAS TRANSPORTED AND ADMITTED INTO THE HOSP WITHOUT FURTHER INCIDENT.
CO EVALUATED THE UNIT AND OBSERVED PROPER OPERATION DURING PERFORMANCE AND FUNCTIONAL TESTING. A PACEMAKER HARDWARE FAILURE CODE WAS OBSERVED LOGGED ON THE FAULT CODE MEMORY STACK. THE CHART/PACER PCB WAS REPLACED, THE UNIT WAS TESTED AND RETURNED TO THE CUSTOMER FOR USE. CO EVALUATED THE CHART/PACER PCB, HOWEVER NO MALFUNCTIONS OR FAILURE CODES WERE OBSERVED DURING REPEATED PERFORMANCE AND FUNCTIONAL TESTING.
ON TWO SEPARATE OCCASIONS, AIR WAS NOTED IN THE TUBING TO THE PT. THERE WAS NO RESULTANT PT COMPLICATION.
THE SAMPLE WAS RECEIVED AND VISUALLY AND FUNCTIONALLY TESTED. THE SET WAS FOUND TO LEAK FROM THE WELD AREA OF THE SENSING DISC MEMBRANE. FURTHER EVALUATION REVEALED THAT THIS  FILM HAD NOT BEEN FULLY WELDED TO THE DISC. IT IS SUSPECTED THAT THE INCOMPLETE WELD OF THE FILM WAS CAUSED DURING THE ASSEMBLY OF THE SENSOR DISC WELDER. THE MFR IS CURRENTLY DEVELOPING AN ON-LINE LEAK TESTER THAT WILL DETECT LEAKING SENSOR DISCS AT THE SENSING DISC WELDER DURING ASSEMBLY. IN ADDITION, PROCESS IMPROVEMENTS FOR THE WELDER HAVE BEEN MADE TO ADDRESS THIS ISSUE.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED BOWEL PROCEDURE. THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. EXPIRATION DATE: 4/30/2001.
10/18/95-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
AN ATTEMPT WAS MADE TO COUNTERSHOCK A PT WITH THE DEVICE. ACCORDING TO THE OPERATOR, THE DEVICE CHARGED TO AN ENERGY LEVEL NOT SELECTED, CAUSING HER TO DISCHARGE THE DEVICE WITHOUT SIGNALING CLEAR. A NURSE WHO WAS IN PHYSICAL CONTACT WITH THE PT REPORTEDLY RECEIVED A SHOCK AT THIS TIME. THE NURSE REPORTED FEELING NO ADVERSE AFFECTS AS A RESULT.
THE RPTR OBSERVED PROPER EQUIPMENT OPERATION. THE UNIT WAS SUBSEQUENTLY GIVEN TO THE LOCAL CO SVC REP FOR EVAL. THE REP OBSERVED PROPER DEVICE OPERATION, THROUGH FULL PERFORMANCE AND FUNCTIONAL TESTING. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC BOWEL RESECTION PROCEDURE. THE INSTRUMENT WAS DIFFCULT TO REMOVE. THE SURGEON MANUALLY MANIPULATED THE DEVICE OF THE TISSUE WITHOUT INCIDENT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. EXPIRATION DATE: 8/31/2001.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE TROCAR WOULD NOT ARM. ANOTHER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.
DEVICE RETURNED WITH NO LOT IDENTIFICATION.
PT WAS CHRONICALLY DISLOCATING SO IMPLANTS WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
CAPSULECTOMY W/REMOVAL AND EXCHANGE OF IMPLANTS (BILATERAL) RUPTURED BILATERALLY.
THE PT WAS HAVING AN ANGIOGRAPHIC PROCEDURE IN RADIOLOGY/VASCULAR AREA. (AORTOGRAM WITH RUN-OFFS). THE TOP OF THE ANGIOGRAPHIC CATHETER SPONTANEOUSLY SEPARATED FROM THE DEVICE. ATTEMPTS WERE MADE TO RETRIEVE THE FRAGMENT FROM THE PROFUNDA-FEMORIS ARTERY USING A SNARE DEVICE. ATTEMPTS WERE UNSUCCESSFUL AND THE PT WAS TAKEN TO SURGERY TO REMOVE THE FRAGMENT.
A NURSE WAS PERFORMING A 200J ROUTINE SHIFT CHECK, AND REC'D AN UNINTENDED DELIVERY OF ENERGY. THE NURSE INDICATED THAT SHE USED HER INDEX FINGER TO DISCHARGE THE UNIT AND HER THUMBS WERE RESTING ON THE PADDLES. SHE FELT THE ENERGY MOVE UP HER LEFT ARM, ACROSS HER NECK AND DOWN HER RIGHT ARM. THE SHOCK "JOLTED" HER ARMS BACK AND SHE COULD SMELL FLESH BURNING. THE NURSE WAS EXAMINED AND SHE HAD A FIRST DEGREE BURN ON HER RIGHT THUMB. THE BURN WAS NOT TREATED AND BY THE SECOND DAY, THE REDDENING WAS GONE. THE NURSE INDICATED THAT SHE FELT "WEIRD AND NAUSEOUS". AN ER PHYSICIAN PERFORMED AN EKG, AND THE RESULTS WERE FINE. THE NURSE WAS SENT HOME FOR THE DAY AND SHE EXPERIENCED NO FURTHER SYMPTOMS FROM THE INCIDENT. AFTER THE NURSE REC'D THE DELIVERY OF ENERGY, A SECOND NURSE TURNED THE UNIT'S ENERGY SETTING TO 0J AND UNPLUGGED THE UNIT. THE SECOND NURSE NOTICED THAT THE RIGHT PADDLE WAS NOT SECURELY PLACED IN THE PADDLE WELL. IT WAS UP AND OUT FROM THE PADDLE WELL. THERE WAS NO ADVERSE EFFECT ON THE NURSE. THE FACILITY HAS ATTRIBUTED THE EVENT TO USER ERROR. THE OPERATOR'S MANUAL CONTAINS DETAILED INSTRUCTIONS ON PERFORMING THE 200J SELF TEST. IT INDICATES THAT USERS SHOULD USE THIER THUMBS TO DISCHARGE THE UNIT. REFERENCE PAGE 40 FROM THE MANUAL.
THE BOVIE SOUND DID NOT ALERT THE TREATING PHYSICIAN THAT HE HAD ACTIVATED THE MACHINE BY PRESSING DOWN ON THE FOOT PEDAL. CONSEQUENTLY, THE POSTERIOR VAGINAL WALL WAS BURNED. A SURGEON RESECTED THE BURNED AREA TO SPEED HEALING AND TO AVOID THE DEVELOPMENT OF A VAGINAL-RECTAL FISTULA.
THE GLOVE APPARENTLY TORE DURING A SURGICAL PROCEDURE. THE CAUSE OF THE TEAR CANNOT BE DETERMINED, SAMPLE NOT AVAILABLE. LOT NUMBER NOT AVAILABLE.
A TEAR WAS NOTICED IN THIS GLOVE BY THE HEALTHCARE WORKER WHO WAS WEARING THE GLOVE DURING A THYROIDECTOMY PROCEDURE. THE CAUSE OF THIS TEAR COULD NOT BE DETERMINED. B4 DATE IS THE DATE THAT INFO WAS RECEIVED BY THE MFR. F8 DATE IS THE DATE THAT THE MFR BECAME AWARE OF THIS EVENT. H6 NA USED DUE TO NO SAMPLE, NO LOT NUMBER AVAILABLE FOR INVESTIGATION.
WHEN THE OTHER CO'S LEAD WAS CONNECTED TO THE PACER, THE LEAD PULLED OUT OF THE HEADER WITH THE SIDELOCK CLOSED. A SECOND 292-09X WAS USED WITHOUT PROBLEMS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
THE DEVICE WAS SUBJECTED TO CONNECTOR DIMENSIONAL TESTING AND A LEAD EXTRACTION TEST WITH A VS-1 LEAD. EXTRACTION DID NOT OCCUR WITH A FORCE OF 13 NEWTONS. IS-1 LEADS ARE KNOWN TO REQUIRE LESS FORCE TO REMOVE (6.5-9.5 NEWTONS). THE DEVICE OPERATES PROPERLY.
VITRECTOMY PUMP QUIT DURING CASE. COMPLETED PROCEDURE USING MANUAL TECHNIQUE. NO PT INJURY REPORTED.
CO CO REP REP CONFIRMED COMPLAINT INT HE FIELD AND REPLACED PUMP. SYSTEM IS NOW WORKIGN ACCORDING TO SPECS. PT INFO REQUESTED, BUT NOT REC'D TO DATE. THIS REPORT WAS MAILED IN TO FDA ON: 10/18/96. DISCLAMIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
DURING THE FOLLOW UP ON 3/27/96, THE MAGNET RATE WAS 86.0 PPM. WHEN DOING THE FOLLOW-UP ON 8/21/96, NO OUTPUT WAS OBSERVED. THE DEVICE IS PART OF THE DEVICE'S SAFETY ALERT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP CLIPS FELL INTO THE ABDOMEN. THERE WAS NO CONSEQUENCE TO THE PT.
D5,H4: INFORMATION NOT PROVIDED BY AFFILIATE. H6; EVALUATION CODE #400(OTHER); YEILDED JAWS.
ADDITIONAL INFORMATION WAS RECEIVED THROUGH CONVERSATION WITH SURGEON AT THE AMERICAN ACADEMY OF OPHTHALMOLOGY MEETING IN NOV. 1996. INFORMATION SUPPLIED IN SECTION F WAS PROVIDED BY THE MANUFACTURER, NOT OTHER USER FACILITY.
ADDITIONAL INFORMATION OBTAINED FROM SURGEON: THE PT IS REPORTED TO HAVE RHEUMATOID ARTHRITIS AND WAS TREATED POST-OPERATIVELY WITH STEROIDS (DOSE AND DURATION OF THERAPY UNK) FOR THIS CONDITION. SURGEON COMMENTED THAT HE CONTINUES TO USE THIS LENS AS HIS FIRST CHOICE FOR HIS PTS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE SLIPS WERE NOT LOSING ALL THE WAY. THE DEVICE HAD BEEN USED AT THE SUBXYPHOID SITE WHERE THE 511S WAS INSERTED. THERE WAS NO PT CONSEQUENCE.
H4: INFORMATION UNAVAILABLE. 10/7/96 MESSAGE AND 800# LEFT ON OFFICE ANSWERING MACHINE FOR MD CALL BACK. KJB. 10/8/96 NNCL SENT. KJB.
AT IMPLANT, THE DEVICE COULD NOT BE INQUIRED BY BOTH 522-06 OR 522-12. THE DEVICE WAS NOT IMPLANTED AND WILL BE RETURNED FOR ANALYSIS.
EVALUATION SUMMARY: A COMPONENT (C-25) WAS DISLODGED IN THE COMMUNICATION'S CIRCUIT. IT SEEMS THAT THIS WAS CAUSED BY THE DEVICE BEING DROPPED.
AT IMPLANT, WHEN TRYING TO LOCK THE LEAD IN WITH THE SIDELOCK (AFTER PUTTING SILICONE OIL ON THE LEAD), THE DEVICE COULD NOT FIX THE LEAD BECAUSE THE SIDELOCK LOOSENED UPWARD. THE DEVICE WAS NOT IMPLANTED.
THE REPORTED "SIDELOCK WON'T CLOSE" WAS VERIFIED DURING BENCH TESTING. THE ANALYSIS REVEALED INSUFFICIENT FRICTION EXISTS IN THE SIDELOCK ASSEMBLLY TO ENSURE THAT THE SIDELOCK WILL REMAIN CLOSED ON A CHRONIC LEAD.
NEEDLE SEPARATED FROM THE HUB WHILE PRIMING THE CANNULA. NO PT IMPACT WAS REPORTED.
THE GLUE BOND CONNECTING THE CANNULA TO THE HUB FAILED. THERE HAVE BEEN NO SIMILAR REPORTS ON THIS LOT. THE MFR'S INTERNAL REF. #0296-0403.
IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE AFTER 3 TO 4 INFLATIONS. NO PT INJURIES OR COMPLICATIONS OCCURRED.
FEMORAL BRUSH BRISTLES PARTICLES BROKE OFF INTO WOUND. REMOVED PARTICLES AND IRRIGATED WELL.
9-20-96 SECTION E4 STATES MFR HAS BEEN NOTIFIED, BUT CO HAS RECEIVED NO COMPLAINTS OF THIS NATURE SINCE THE EVENT DATE (8-02-96). ALTHOUGH REPORT STATES 207-59, DESCRIPTION INDICATES 207-54. ALSO, (D9) PRODUCT WAS NOT RETURNED TO CO. FORM 3500 PROVIDED BY REPORTER INDICATES NO CONTACT PERSON AND THEREFORE, CO IS UNABLE TO CONDUCT A COMPLETE INVESTIGATION. CO IS PROVIDING AVAILABLE INFO. DATES SHOWN AS "00/00/00" ARE UNKNOWN, EXCEPT IN SECTIONS B2, D5, D7 AND D8 WHERE DATE IS NOT APPLICABLE.
THE PEEP PLUG OF THE SWIVEL ADAPTER BECAME DISLODGED AT APPROX 45 CM H2O PEEK INSPIRATORY PRESSURE. THE EVENT OCCURRED ON AN ADULT PT.
PRODUCT EVALUATION: SIMS TESTING OF THE RETURNED DEVICE FAILED TO DUPLICATE DISLODGE OF THE PEEP KEEP PLUG AT 45CMH2O PEEK INSPIRATORY PRESSURE. THIS WAS REPORTEDLY THE PRESSURE AT WHICH THE PLUG BECAME DISLODGED AT THE USER FACILITY. SIMS ALSO TESTED THE DEVICE AT 60CMH2O (HIGHEST AVERAGE PRESSURE FOR A VENTILATED PATIENT) AND AGAIN COULD NOT DUPLICATE THE REPORTED DISLODGE. IT IS LIKELY AN EXTERNAL FOCE EXERTED ON THE PEEP KEEP PLUG IS CAUSING OR CONTRIBUTING TO THIS EVENT.
CANNULA FELL OFF THE SYRINGE WHILE IT WAS IN THE WOUND. THERE WAS NO CHANGE IN THE WOUND AND NO PT INJURY WAS EXPERIENCED. UPON FOLLOW UP WITH REPORTER A POTENTIAL EXISTS FOR INJURY IF EVENT WERE TO RECUR.
THE COMPLAINT WAS ORIGINALLY REC'D ON 8/20/96. INFO REC'D ON 9/19/96 INDICATED THE POTENTIAL FOR INJURY IF MALFUNCTION WERE TO RECUR. THE RETURNED PRODUCT WAS EVALUATED AND THE GLUE BOND CONNECTING THE CANNULA TO THE HUB, FAILED. NUMBER OF PERSONS AFFECTED=1. THIS REPORT WAS MAILED IN TO FDA ON 10/18/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. UPON REMOVAL OF THE STAPLE CAP FROM THE CARTRIDGE HOUSING, IT WAS NOTED BY THE SURGEON THAT THE STAPLES HAD PROTRUDED OUT OF THE HOUSING. COMPLETED BY OPENING A NEW INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: BASED ON THE INFORMATION RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS EXAMINED FOR PROTRUDING STAPLES WITH NONE NOTED. HOWEVER, IT HAS BEEN OBSERVED THAT THE CONDITION OF PROTRUDING STAPLES CAN BE CREATED IF THE ADJUSTING KNOB IS DIALED OPEN TOO FAR OR BEYOND THE POINT WHERE THE ADJUSTING KNOB PROVIDES RESISTANCE ONCE THE ORANGE TYING AREA IS VISIBLE. AS STATED IN THE PACKAGING INSERT, THE INSTRUMENT SHOULD BE OPENED ONLY UNTIL THE ORANGE TYING AREA IS CLEARLY VISIBLE ABOVE THE STAPLE HOUSING. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
USER REPORTED AN ALARM DURING SELF TEST AS PART OF SET-UP PROCEDURES FOR A PT. ALARM (JET VALVE FAULT) INDICATED A DEVICE MALFUNCTION PREVENTING DEVICE USE. THE PT WAS TREATED WITH A BACK-UP VENTILATOR. THERE WAS NO INJURY.
FREQUENCY AND SEVERITY OF THIS EVENT ARE NOT ADDRESSED IN THE DEVICE LABELING AND ARE NOT GREATER THAN USUAL. THE FILING OF THIS REPORT DOES NOT REFLECT A CONCLUSION BY CO THAT THE REPORT SHOWS THE DEVICE IS DEFECTIVE, NOR DOES IT CONSTITUTE AN ADMISSION THAT THE DEVICE CUASED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
WHILE MANEUVERING C-ARM INTO OBLIQUE POSITION, OVERHEAD SUSPENSION ARM WAS BUMPED. ARM DETACHED FROM CEILING AND FELL TO FLOOR. ARM HELD INJECTOR HEAD AND LEAD GLASS SHIELD.
RESULTS OF EVAL: CONCLUSION-BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS-IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
CATHETER WAS USED TO PREDILATE A VERY CALCIFIED LESION. BALLOON WAS INFLATED TO 8 ATM AND LOST PRESSURE. DR FELT A SPICULE IN THE VESSEL CAUSED A PINHOLE IN THE BALLOON. WHEN THE BALLOON WAS REMOVED, AN ANTICIPATED DISSECTION WAS NOTED, BUT THE DR FELT IT WAS NOT THE RESULT OF THE PINHOLE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED UNEVENTFULLY. NO OTHER DETAILS WERE RECORDED.
ANY INFO OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO UNABLE TO PROVIDE COMPLETE INFO REQUIRED IN FORM 3500A. ROOT CAUSE ANALYSIS OF THE CATHETER INDICATED THE BALLOON BURST WAS DUE TO AN SMALL TEAR NEAR THE DISTAL END. ADD'L SCANNING ELECTRON MICROSCOPE INSPECTION REVEALED JAGGED EDGES ON THE TEAR AND SIGNS OF SCORING LEADING INTO THE TEAR. THE USER STATED THE LESION WAS VERY CALCIFIED. THIS TYPE OF TEAR AND SCORING ARE CONSISTENT WITH CALCIFICATION DAMAGE. THE CUSTOMER WAS INFORMED OF THE EVAL RESULTS WITH SEM PHOTOS OF THE DAMAGE. NO OTHER CORRECTIVE ACTION REQUIRED AT THIS TIME.
IT WAS REPORTED THAT DURING A PTCA, THE BALLOON WOULD NOT DEFLATE WHEN NEGATIVE PRESSURE WAS GIVEN. THE PHYSICIAN RUPTURED THE BALLOON TO SAFELY WITHDRAW THE CATHETER FROM THE PT. NO KINKS WERE VISIBLE IN THE SHAFT AND GUIDE WIRE MOVEMENT WAS REPORTED TO BE GOOD. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT.
EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FORM EVALUATION ON 9/4/96. THE ANALYSIS CONFIRMS THAT A 3MM LONGITUDINAL RUPTURE OF THE BALLOON HAD OCCURRED. HARDENED/CRYSTALLIZED CONTRAST WAS NOTED IN THE TAPER OF THE RUPTURED BALLOON, LUMEN OF THE SHAFT AND WIRE/INFLATION PORTS OF THE SIDEARM. FURTHER ANALYSIS OR INVESTIGATION COULD NOT BE PERFORMED DUE TO THE HARDENED CONTRAST IN THE DEVICE. BASED ON THE REPORTED INFOR, WE ARE UNABLE TO DETERMINED WHY THE BALLOON WOULD NOT INITIALLY DEFLATE WHEN NEGATIVE PRESSURE WAS GIVEN.
PER THE INFO PROVIDED TO CO THROUGH ITS INTERNATIONAL REPRESENTATIVE, THE PT IS EXPERIENCING A "BROKEN" DEVICE.
NO MEDICAL INTERVENTION, MEDICAL OR SURGICAL HAS OCCURRED AS OF THE DATE OF THIS REPORT. A REQUEST HAS BEEN MADE FOR ADD'L INFO AND THE RETURN OF THE DEVICE SHOULD SURGICAL INTERVENTION OCCUR. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVALUATION WILL BE FORWARDED UPON COMPLETION.
THE DEVICE WAS USED DURING AN UNREPORTED PROCEDURE. IT WAS REPORTED THE EZ35 MISFIRED. THERE WAS NO CONSEQUENCE TO THE PT. LOT #J43261, BATCH #2001-04.
EES#: 964811. A1,2,3,4; B3,6,7; D10 ATTEMPTED TO CONTACT HOSPITAL. INFO NOT AVAILABLE. D5; H4,6 INFO ANTICIPATED, NOT UNAVAILABLE AT THIS TIME. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. THE RETURNED CARTRIDGE HAD THE LOCKOUT TAB AND MIDDLE ALIGNMENT FINGER BROKEN OFF. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW READING INSTRUCTIONS.
ON 9/15/96 THE PT OBTAINED A HOME PREGNANCY TEST RESULT=POSITIVE. ON AUGUST 15, 1996 A NEGATIVE RESULT WAS OBTAINED USING TEST LOT NUMBER UNK. IT HAD BEEN 5 WEEKS SINCE HER LAST MENSES AT THAT TIME. ON 8/29/96 THE PT HAD A NEGATIVE RESULT USING LOT NUMBER 18467M400. ON 9/16/96 THE TEST AGAIN GAVE A NEGATIVE RESULT. THE PT VISITED THE DOCTOR ON 9/17/96 WHO CONFIRMED PREGANCY BY PELVIC EXAM. NO REPORT OF INJURY. NO SAMPLES ARE AVAILABLE FOR RETURN.
THIS IS A FOLLOW-UP TO REPORTER'S PREVIOUS REPORT. REPORTER HAD A SEVERE ANAPHYLACTIC REACTION AFTER USING THE GLOVE. HER DR IS TELLING HER THAT SHE CANNOT BE IN AN ENVIRONMENT WHERE LATEX PRODUCTS ARE USED.
UNIT #22810; BOVIE PENCIL BLADE HAD SECTION OF ROBNEL CATHETER COVERING IT FROM PENCIL TO NEAR THE TIP OF THE BLADE. THE ROBNEL BURNED AT THE BLADE TIP ON ACTIVATING THE PENCIL UNIT. INCIDENT OCCURRED WITHOUT PT CONTACT.
ON 9/18/96, A PHENYTOIN RESULT OF .12 UG/ML WAS OBTAINED WHILE RUNNING THE ANALYZER. THIS RESULT WAS REPORTED AND THE PT WAS GIVEN A DOSE OF PHENYTOIN BASED ON THE RESULT. THE PT WAS REDRAWN AFTER MEDICATION WAS ADMINISTERED. A RESULT OF 38 UG/ML WAS OBTAINED. THE INITIAL SAMPLE WAS THAN RERUN AND RESULTS OF 20 AND 17.4 UG/ML WERE OBTAINED.
INVESTIGATION SUMMARY: THE EVENT REPRESENTED IS NOT ADDRESSED IN THE DEVICE LABELING. A MALFUNCTION DID OCCUR. THIS REPORTABLE MDR EVENT WAS INVESTIGATED AS PART OF AN ONGOING STUDY OF THE AXSYM SYSTEM BY ABBOTT INTO THE CAUSATIVE REASON FOR MALFUNCTIONS. RESULTS OF THE INVESTIGATION YIELDED A NUMBER OF SYSTEM ENHANCEMENTS IMPLEMENTED ON CUSTOMER UNITS. IMPROVEMENTS INCLUDED AXSYM SOFTWARE VERSION 3.0 WITH ENHANCED ALGORITHM FOR FLUID DETECTION, NEW BUFFER TUBING AND SEAL FITTINGS WHICH REDUCED BUBBLES FORMING IN TUBING LINES, MODIFICATIONS TO THE LIQUID LEVEL SENSE BOARD TO DECREASE AND PACKAGING MODIFICATIONS FOR ADDED PROTECTION TO PROBES. IN ADDITION, ABBOTT HAS EMPHASIZED TO OUR CUSTOMERS THAT CORRECT OPERATING PROCEDURES MUST BE FOLLOWED TO ENSURE OPTIMAL PERFORMANCE OF THE AXSYM SYSTEM. AREAS THAT WERE EMPHASIZED INCLUDED PROBE CRASH RECOVERY PROCEDURE, RECOMMENDED TUBE SIZE AND TYPES, OPENING REAGENT BOTTLE 4, PROPER LOADING/UNLOADING OF REAGENT PACKS, AND ENSURING PROPER SAMPLE AND REAGENT HANDLING. THIS IS THE FINAL REPORT.
THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. IT WAS REPORTED BY THE REP WHEN FIRING INSTRUMENT ON LUNG TISSUE DURING A VATS PROCEDURE THE BLACK LEVER BROKE. THIS WAS THE THIRD FIRING OF THE INSTRUMENT. SWITCHED TO A NEW INSTRUMENT TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
CODE #400- DAMAGED FIRING MECHANISM. RESULTS OF EVALUATION: CONCLUSION; BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
ADDITIONAL INFO RECEIVED FROM MFR ON 12/13/1996: THE ACTUAL PRODUCT INVOLVED IN THE COMPLAINT WAS RETURNED TO QUIDEL FOR VISUAL INSPECTION. RESULTS OF THIS INSPECTION BY QUIDEL SHOWED THAT THE KIT LOT NUMBER AND EXPIRATION DATE WERE NOT PRINTED ON THE OUTSIDE OF THE PACKAGE, BUT THE LOT NUMBER, 0297F0861, AND EXPIRATIONDATE, 24 MAR, 1998, WERE PRESENT AND CLEARLY LEGIBLE ON THE INNER WRAPPER. TO DATE, CO HAS RECEIVED ONLY 4 OTHER COMPLAINTS OF UNRELATED NATURE ON THIS LOT NUMBER.
COMPLAINANT STATES THAT THE METAL PLUG COMPONENT OF THE ACETABULUM PROSTHESIS WOULD NOT ASSEMBLE CORRECTLY. SURGERY WAS PROLONGED (MINIMALLY) AS A RESULT OF THIS EVENT. NO INJURY TO THE PT WAS REPORTED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY, INC. OR ITS AFFILIATES.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT REMOVAL. A FAULTY UF (ULTRAFILTRATION) PUMP THERMAL FUSE WAS FOUND. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY OF THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT THERE WAS A SIMILAR INCIDENT IN 8/96 (CPF #0896298C3). THE UF PUMP WAS REPLACED AS A PRECAUTION. NO PROBLEM WAS FOUND WITH THE RETURNED UF PUMP. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS RPRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO DBE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/8/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED OL, INDICATING THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISSASEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSED THE WAX TO MELT. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: N. SZALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED UPON THE SECOND FIRING OF THE DEVICE THE INSTRUMENT LOCKED AND WOULD NOT FIRE. A SECOND INSTRUMENT WAS OPENED TO FINISH THE CASE. NO BUTTRESSING MATERIAL WAS USED. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVAL: CONCLUSION-BASED ON THE INQUIRY INFO AND THE VISUAL EXAMINATION IT WAS CONCLUDED THAT THE REPORTED INCIDENT MAY HAVE BEEN DUE TO A DEFECTIVE COMPONENT. COMMENTS-CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE AFTER 3 OR 4 INFLATIONS. NO PT INJURIES OR COMPLICATIONS OCCURRED.
BOVIE PENCIL BLADE HAD SECTION OF ROBNEL CATHETER COVERING IT FROM THE PENCIL TO NEAR THE TIP OF THE BLADE. THE ROBNEL BURNED AT THE BLADE TIP ON ACTIVATING THE PENCIL UNIT. INCIDENT OCCURRED WITHOUT PT CONTACT.
THE PENCIL WAS EVALUATED & A LARGE ORANGE ROBNEL CATHETER COVERED THE NOSE OF THE PENCIL. THE ROBNEL CATHETER WAS REMOVED & A SMALL CRACK IN THE ELECTRODE INSULATION WAS VISIBLE. HIGH VOLTAGE WITHSTAND TESTING INDICATED A BREAKDOWN AT THIS LOCATION. THE CAUSE OF THE CRACK WAS UNDETERMINED. THE ELECTRODES ARE TESTED DURING RECEIVING INSPECTION & SAMPLED DURING MFG FOR THIS CONDITION. THIS CONDITION WAS UNRELATED TO THE CUSTOMER'S REPORT. PRODUCT LABELING CAUTIONS THE USER REGARDING OXYGEN. THIS INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MDR. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF CO THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH  STATUTORY AND COMMON LAW.
PT PULLED OUT UROLOGICAL CATHETER. TIP OF CATHETER MISSING; SHEARED OFF.
THE PT WAS BEING FED THROUGH A GASTROSTOMY TUBE USING A PUMP. THE PUMP WAS SET TO DELIVER 60 ML/HR. WHEN CHECKED, FOUND IT HAD DELIVERED 180 ML IN 1 HR SPAN. THE PUMP WAS IMMEDIATELY TURNED OFF. BACK-UP PUMP WAS STARTED AND SET AT PROPER DOSAGE-WORKING PERFECTLY. MD WAS INFORMED. PT WAS ASSESSED FOR ANY SIGNS OR SYMPTOMS OF FLUID OVERLOAD. MONITORED PT CLOSELY. THERE WAS NO ILLNESS, INJURY OR MEDICAL INTERVENTION RESULTING FROM THE EVENT. ONE PT INVOLVED.
PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE REPORTER FOR COMPLETION. IN THIS CASE, THE REPORTER DID NOT PROVIDE THE REQUIRED INFO IN SECTIONS F2 AND F10. A REPORT WAS SENT TO FDA ON 9/19/96. EXCESSIVE SPILLAGE ON COVER ARM, ROTOR ROLLERS, MOTOR PLATE & DROP DETECTOR. BACK OF TUBEGUIDE SHOWS SIGNS OF RUBBING. BATTERY ACCESS PANEL BENT. OVER DELIVERY; OF 60 ML/HR OF UNKNOWN PRODUCT WAS RUN FOR 1 HR. 180 ML DELIVERED. PUMP DELIVERED WITHIN SPEC WITH NO DIFFICULTIES NOTED DURING TEST. CUSTOMER COMPLAINT (OVER DELIVERY) WAS NOT CONFIRMED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
BILATERAL CAPSULECTOMIES WITH REMOVAL AND EXCHANGE OF INTACT IMPLANTS.
THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE HOSP DID NOT PROVIDE ANY FURTHER INFO. EXPIRATION DATE: 2/28/2001.
A PULSE OXIMETER WAS ATTACHED TO THE HAND OF THE INFANT GIRL AND WAS FUNCTIONING PROPERLY. THE ALARM SOUNDED AND AFTER DETERMINING THAT THE PT READINGS WERE APPROPRIATE, THE ALARM WAS TEMPORARILY SILENCED (19:30). AT 19:35 THE PT WAS CHECKED AGAIN AND THE MACHINE APPEARED TO BE FUNCTIONING PROPERLY AND THE PT READINGS WERE APPROPRIATE. AT 19:55 THE PT WAS CHECKED AND FOUND TO BE UNRESPONSIVE; NO 02 SATS OR PULSE REGISTERED, NO READING PRESENT, MACHINE IN A PULSE SEARCH MODE AND THE RED LIGHT ON. NO ALARM WAS SOUNDING. RESUSCITATION ATTEMPTS PROVED UNSUCCESSFUL AND THE PT EXPIRED.
DURING A POST STENT DILATATION PROCEDURE, THE BALLOON WOULD NOT DEFLATE. THE BALLOON DELFATED IN APPROXIMATELY TWO MINS. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVALED KINKS IN THE GUIDE WIRE LUMEN WHICH RESULTED IN GUIDE WIRE MOVEMENT DIFFICULTIES. DUE TO THE WIRE MOVEMENT DIFFICULTIES, TESTING RELATIVE TO THE REPORTED DEFLATION DIFFICULTIES COULD NOT BE PERFORMED. NO MATERIAL OR MFG DEFICIENCIES WERE NOTED.
A 49-YR-OLD FEMALE HAD PLANNED REMOVAL OF BILATERAL, GEL BREAST IMPLANTS. MRI CONFIRMED RUPTURE OF BOTH IMPLANTS. THESE IMPLANTS WERE PLACED IN 1982 OR 1983.
THE PRODUCT WAS USED DURING A MASTECTOMY PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HSP HAS REPORTED THAT NO PT INJURY OCCURRED. EXPIRATION DATE: 7/31/2001.
THE DEVICE WAS USED DURING A RESECTION OF THE PULMONARY ARTERY. THE INSTRUMENT WAS FIRED AND THE DOCTOR THOUGHT THERE WERE NO STAPLES IN THE CARTRIDGE. THE SURGEON COMPLETED WITH ANOTHER INSTRUMENT. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/16/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
HISTORY OF 2 MONTH PERIODIC LEFT LOWER LEG ERYTHEMA WITH MODERATE SWELLING. MARCH 96 - ARTHROTOMY PERFORMED WITH SCAR TISSUE REMOVED FROM LEFT KNEE. PRIOR COMPONENT PLACEMENT AT ANOTHER HOSP IN 7/88. EVE OF 9/19 REPORTED TO ER COMPLAINING OF PAIN, ERYTHEMA, SWELLING (MODERATE) OF LEFT KNEE. POSITIVE HOMAN'S SIGN. NON INSULIN DEPENDENT DIABETIC. I & D OF KNEE ON 9/20/96. LEFT KNEE COMPONENT REMOVED 9/26/96.
BILATERAL CAPSULECTOMY WITH REMOVAL OF BILATERAL RUPTURED IMPLANTS.
10/18/96-MEDWATCH REPORT NOT RECEIVED BUY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO CLINICIAN 2 IMPLANTS WERE PLACED IN CLASS III BONE IMMEDIATELY POST-EXTRACTION. THE CLINICIAN REPORTS THE IMPLANT IN SITE #29 BECAME INFECTED AND WAS REMOVED 2 MONTHS POST-OPERATIVELY.
HEALTHCARE PROFESSIONAL REPORTED BREAKAGE OF 6492 TEMPORARY PACING WIRE. THE SURGEONS HAD BROKEN THE MONOFILAMENT SUTURE. IT WAS FELT THAT THE BREAKAGE MAY HAVE BEEN DUE TO THE SURGEONS TECHNIQUE. ALSO REPORTED THAT IN THE SAME LOT OF 6492 WIRES, 2 PRODUCTS WERE OPENED AND DISCARDED DUE TO "LINT" OR "FUZZ" ON THE MONOFILAMENT SUTURE PORTION OF THE PRODUCT. THE HOSPITAL LOST THE PRODUCTS THEREFORE NO PRODUCT WAS RETURNED FOR ANALYSIS.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." CONCLUSION CODE #68 OTHER=NO FAILURE DETECTED AND PRODUCT WAS WITHIN SPECIFICATION WHEN RELEASED FOR CLINICAL USE PER TESTING DOCUMENTATION ON DHR. NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY THEREFORE, INFO ON THIS MEDWATCH FORM 3500A WAS COMPLETED BY CO WITH INFO RECEIVED FROM THE HEALTHCARE PROFESSIONAL. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A." H3 ANALYSIS: AS NO PRODUCT WAS RETURNED FOR INVESTIGATION, REVIEW OF THE DEVICE HISTORY RECORD INDICATE THAT AT THE TIME OF MANUFACTURE THE PRODUCT MET ALL SPECIFICATIONS FOR PULL STRENGTH, DIAMETER, JUNCTIONS, NEEDLE AND ELECTRODE TIP. VISUAL INSPECTION PRIOR TO STERILIZATION INDICATES THAT THE PRODUCT MET REQUIREMENTS FOR NO FOREIGN MATERIAL. INVESTIGATION INTO THE "LINT" ON THE MONOFILAMENT SUTURE FOUND THAT THE FIBER COULD BE REPRODUCED BY RUBBING ALONG THE WIRE WITH LATEX GLOVES.
IT WAS REPORTED BY THE MFG SITE THAT SETS WERE PULLED FORM THE WAREHOUSE FOR UNRELATED QUALITY ENGINEERING TESTING. IT WAS OBSERVED THAT THE BALL WAS MISSING FROM THE FLOW STOP SET. THIS RESUTLED IN UNCONTROLLED FLOW. THE SET WAS NOT BEING USED IN A CLINICAL ENVIORMENT THEREFORE WAS NOT USED ON A PT.
MFR FINAL REPORT INSTRUMENT WAS FOUND TO MEET MFR'S SPEC. NO FAULT FOUND. SUSPECT POSSIBLE MISLOAD OF IV SET. EVAL OF THE SET REVEALED THE FLOW STOP BALL WAS MISSING. CHANGES TO THE INSPECTION AND TESTING PROCESS WILL BE IMPLEMENTED TO PREVENT RECURRENCE OF THE MISSING BALL. SECTION A 1-4, B-6&7,AND F-10 NOT FILLED OUT BECAUSE THE SET WAS NOT IN USE IN A CLINICAL ENVIRONMENT OR ON A PT. SECTION F-2 IS NOT FILLED IN BECAUSE THERE WAS NO REPORT FILED BY THE MFG SITE. MFR'S REPORT DATE: 10/11/96.
TIP OF GUIDE WIRE BROKE OFF IN CIRCUMFLEX CORONARY ARTERY. PHYSICIAN HAD TO SNARE WIRE FRAGMENT FROM CORONARY ARTERY. PT NOT HARMED.
PT RETURNED TO SURGERY FOR REPLACEMENT OF BROKEN RIGHT FEMORAL STEM
DURING A REOPERATION, THE SURGEON LOCATED A COMPONENT THAT DISENGAGED FROM THE DEVICE DURING THE ORIGINAL SURGERY. THE SURGEON HAS INDICATED THAT THE DISENGAGED COMPONENT WAS NOT THE CAUSE FOR THE REOPERATION.
THE CUSTOMER RETURNED THE 550 FOR REPAIR. REPORTED PROBLEM: LEAKS. DURING FUNCTIONAL EVALUATION, ENOUGH LIQUID OXYGEN LEAKED FROM THE CRACKED CONNECTING TUBES TO POTENTIALLY CAUSE A SERIOUS INJURY SHOULD THIS MALFUNCTION RECUR. CO'S SERVICE TECH ALSO REPORTED THAT THE WRONG STRAP WAS INSTALLED, THE BEZEL, KNOB, CASE FRONT, AND CASE BACK WERE CRACKED, THE BOTTLE HAD A VACUUM LOSS, AND THE PNUEMATIC DEMAND DEVICE WAS OUT OF ADJUSTMENT. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MANUFACTURING PROCESS PER THE APPROVED DMR. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED WHICH REPLACED THE CONNECTING TUBES WITH A MORE DURABLE MATERIAL ON UNITS MANUFACTURED AFTER 9/13/95.
PT PRESENTED WITH A FIVE DAY HISTORY OF SEVERE HEADACHES AND "SLEEPINESS" AS WELL AS NAUSEA/VOMITING. PT HAD VP SHUNT INSERTED 10 YRS AGO FOR HYDROCEPHALUS. UPON SURGICAL REMOVAL OF SHUNT IT "CRUMBLED."
THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT MADE A HOLE IN A TISSUE. THE HSP AND SURGEON WERE UNWILLING TO PROVIDE ADD'L INFO. HOWEVER, THEY DID NOTE ATHAT NO PT INJURY OCCURRED. EXPIRATION DATE: 8/31/2000.
6/10/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. PRODUCT WAS NOT RETURNED TO MFR FOR EVALUATION.
THE DEVICE WAS APPLIED DURING A LOBECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON MANUALLY MANIPULATED THE DEVICE OFF THE TISSUE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PENCIL DOES NOT TURN OFF. THE DR TOLD THE DISTRIBUTOR THAT THERE WAS A LITTLE SIZZLING, IT DID CAUTERIZE TISSUE, BUT IT WAS VERY MONOR AND IT IS ALL HEALED UP NOW. THE PT WAS NOT EVEN AWARE OF IT.
INVESTIGATION OF THE ABOVE REFERENCED COMPLAINT HAS BEEN COMPLETED. THE ORIGINAL COMPLAINT STATING THAT "PENCIL DOES NOT TURN OFF." WAS RECEIVED 9/18/96, & DEVICE RECEIVED FOR EVAL BY CO 10/11/96. A MALFUNCTION MDR REPORT WITH THE FDA WAS FILED BY CO ON THIS INCIDENT BASED ON THE INFO PROVIDED THAT AN INSIGNIFICANT INJURY OCCURRED HOWEVER REOCCURRENCE COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. EVAL OF INCIDENT DEVICE WAS CONDUCTED BY CO AND PENCILE WAS TESTED INITIALLY AS FUNCTIONING PROPERLY, AFTER SEVERAL TRIALS IT WAS DETERMINED THAT THE ACTIVATION SWITCH WAS BECOMING SLOW TO TURN OFF THUS COULD POSSIBLY REMAIN ON. HOUSING WAS OPENED AND A CONDUCTIVE CONTAMINATION BUILD UP ON THE SWITCH CONTACTS WAS OBSERVED WHICH COULD POSSIBLY CAUSE THE SWITCH TO STICK AND REMAIN ON. THE PRODUCT RETURNED FOR THIS INCIDNET WAS EXPECTED TO BE ONE MFG IN 8/96, HOWEVER REVIEWING THE PENCIL CONFIGURATION, THIS COULD NOT HAVE BEEN CORRECT. THE CONFIGURATION WAS DETERMINED THROUGH RECORDS REVIEW TO BE A DEVICE TYPE WHICH HAS NOT BEEN MFG BY CO FOR AT LEAST 4 YRS, THUS THE AGE OF THE DEVICE COULD NOT BE DETERMINED EXACTLY. IT WAS ALSO NOT DETERMINED HOW MAY TIMES IT HAD BEEN CLEANED OR WHETHER THE METHOD OF CLEANING COULD HAVE CAUSED THE CONTAMINATION TO OCCUR. THERE WAS NO INDICATION OF OTHER PROBLEMS FOUND.
LAPAROSCOPIC CHOLECYSTECTOMY WAS PERFORMED. DURING THE CLOSURE OF THE UPPER MIDLINE SITE, THE SUTURE NEEDLE BROKE WITH THE VERY FIRST PASS. ATTEMPTS TO RECOVER THE DISTAL PORTION OF THE NEEDLE BY LAPAROSOCPIC MEANS WERE UNSUCCESSFUL. X-RAYS CONFIRMED 1.5 CM DISTAL PORTION OF THE NEEDLE, WHICH WAS LOCATED IN THE ANTERIOR ABDOMINAL WALL AND NOT IN THE PERITONEAL CAVITY. IT WAS DECIDED TO LEAVE THE NEEDLE, SINCE REMOVAL WOULD REQUIRE OPEN CONVERSION. THE PT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED THE FOLLOWING DAY. COMPLICATIONS FROM THE NEEDLE ARE NOT EXPECTED, BUT UNK AT THIS TIME.
INVESTIGATION IS IN PROGRESS. REFERENCE MFR COMPLAINT #Z96-337. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAD CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE DILATATION CATHETER WAS USED TO PREDILATE A LESION PRIOR TO STENTING WITH NO COMPLICATIONS. AFTER STENTING THE PHYSICIAN AGAIN USED THE SAME DILATION CATHETER BUT AFTER THE SECOND DEFLATION THE PHYSICIAN WAS NOT ABLE TO DEFLATE THE BALLOON AND HAD TO USE A 50CC SYRINGE TO FULLY DEFLATE THE BALLOON. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. TYPE OF EVENT ADDRESSED IN LABELING. SECTION F10. 1738 FOR CODE 2199. NA FOR CODE 2199. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSP OR DISTRIBUTER. INVESTIGATION OF THE DEVICE FAILED TO REPORDUCE THE PRODUCT CONCERN. BOTH DEFLATION TIMES AND THE INFLATION NOTCH MEASUREMENTS WERE WITHIN SPEC. SOME EVIDENCE OF INNER MEMBER BOWING WAS APPARENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR THE DEVICE FOR INCREASED FREQUENCY FOR THIS TYPE OF PRODUCT ISSUE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
INSERTED IAB AT BEDSIDE WITH NO PROBLEM, BUT BALLOON WOULD NOT UNWRAP. PHYSICIAN REMOVED IAB AND INSERTED ANOTHER, SECOND IAB WORKED FINE.
H-11 ALL UNK INFO REQUESTED NOT RECEIVED. H-11 SECTION F PROVIDED BY MFR. H-11 SECTION F10 DEVICE CODE LABELED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NTO FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HSP HAS REPORTED THAT NO PT INJURY OCCURRED.
OVERDELIVERY REPORTED. THE PUMP WAS REC'D IN THE BIOMEDICAL ENGINEERING DEPT WITH A NOTE STATING, "PUMP NOT RUNNING AT PROPER RATE. IV INFUSES TOO FAST. WHEN CHECKED, BIOMED SAID THE DISPLAY INDICATED SETTINGS OF 65 ML/HR ON THE PRIMARY AND 110 ML/HR ON THE SECONDARY. THE PUMP DELIVERED FOR THEM WITHOUT ERROR. THE NURSE REPORTING THE EVENT STATES. "IT HAPPENED SO LONG AGO I DO NOT RECALL ANYTHING ABOUT THE PT EXCEPT THERE WAS NO ADVERSE EFFFECT". SHE "SEEMS TO RECALL THAT THE PUMP WAS SET AT 100 ML/HR ON THE PRIMARY TO DELIVER A HYDRATION FLUID, BUT THAT IT GAVE A VOLUME OF 500 ML WITHIN 30 MINUTES". SHE COULD NOT REMEMBER ANY MORE DETAILS. SHE STATES AN INCIDENT REPORT WAS NOT MADE BECAUSE THERE WAS NO PT HARM. NO FURTHER INFO IS AVAILABLE.
DURING THE PRIME PROCEDURE OF A CAROTID SHUNT, THE STOPCOCK SEPERATED FROM THE INFLATION LINE. THE PT WAS NOT INVOLVED.
FREQUENCY OF OCCURRENCE STATEMENT (21 CFR 803.24 (C)(7)). FREQUENCY OF OCCURRENCE FOR THIS TYPE OF REPORTED EVENT IS: 2 REPORTED EVENT OUT OF 365 UNITS OF SILICONE SHUNT. (1.548%). SEVERITY OF OCCURRENCE STATEMENT (21 CFR 803.24 (C)(7)). TO CO'S KNOWLEDGE, THIS TYPE OF EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THIS TYPE OF DEVICE.
X-TUBE ASSEMBLY 19" X 18". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE PHYSICIAN COMPLETELY APPLIED A FALLOPIAN TUBE CLIP TO ONE OF THE PT'S TUBES, BUT THE APPLICATOR WOULD NOT RELEASE THE CLIP AS IT SHOULD. SOME MANIPULATION WAS NEEDED TO GET THE CLIP TO SLIDE OUT OF THE APPLICATOR. NO PT COMPLICATIONS WERE REPORTED.
DATA SHOWN IN SECTION F WAS FILLED IN BY THIS US AGENT FOR THE FOREIGN MFR. EVALUATION SUMMERY: THE TIP OF THE INNER SHAFT WAS FOUND TO BE BENT DOWNWARD. THE OUTER SHAFT WAS DENTED AND THE PUSHER ROD GOES FORWARD MORE THAN IT SHOULD. THE CAUSE OF THE PROBLEM IS ATTRIBUTED TO POOR MAINTENANCE AND CARE OF THE DEVICE ON THE PART OF THE USER.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY. THE HOSP HAS REPORTED NO PT INJURY OCCURRED. EXPIRATION DATE: 9/30/2001.
HISTORY OF BILATERAL SUBCUTANEOUS MASTECTOMIES FOR FIBROCYSTIC DISEASE IN 1983. SINCE THAT TIME HAS HAD PAIN INTERMITTENTLY IN BOTH BREASTS. SHE BEGAN TO DEVELOP SYMPTOMS SHE FELT WERE DUE TO IMPLANTS SUCH AS CHRONIC DIGESTIVE DISORDERS.
THE CUSTOMER STATED THAT THE 550 WILL NOT PULSE AND SENT THE UNIT FOR REPAIR. DURING CO'S FUNCTIONAL EVALUATION, ENOUGH LIQUID OXYGEN LEAKED FROM THE SECONDARY RELIEF VALVE TO POTENTIALLY CAUSE A SERIOUS INJURY SHOULD THIS MALFUNCTION RECUR. CO'S SERVICE TECH ALSO REPORTED THAT THE FLOW CONTROL KNOB WAS CRACKED AND THE SENSITIVITY DIAPHRAGM WAS RUPTURED (WHICH DUPLICATED THE REPORTED PROBLEM). THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MANUFACTURING PROCESS PER THE APPROVED DMR. NONE OF THESE FINDINGS APPEAR TO BE ATTRIBUTED TO MANUFACTURING PROCEDURES, PROCESSES, OR SPECIFICATIONS.
THE DEVICE WAS APPLIED DURING AS LAPAROSCOPIC NISSEN PROCEDURE. REPORTEDLY THE CLIPS DID NOT ADVANCE PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. EXPIRATION DATE:6/30/2001.
FOLLOWING CANNULATION IT WAS DISCOVERED THE CONNECTOR HAD CRACKED. THE M.D. USED A HOSP DESIGNED OBTURATOR FOR INSERTION OF THE CANNULA.
DURING THE PROCEDURE THE TUBING OF THIS DEVICE BROKE APART ON THE SECOND INFLATION. THE DEVICE WAS REMOVED AND REPLACED THERE IS NO REPORT OF PT INJURY. THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
DERMATOME MALFUNCTIONED WHILE IN USE, CAUSING A LACERATION 1 CM DEEP AND 7 CM WIDE ON THE PT'S LEFT LEG.
THE SET WAS BLOCKED. THE RPTR INDICATED THAT THIS HAD OCCURRED ON 4 OCCASIONS BUT DID NOT PROVIDE SPECIFIC DETAILS.
THE CUSTOMER RETURNED 3 SAMPLES TO CO FOR EVAL. EXAM OF THE RETURNED UNITS SHOWED THAT 6 UNITS WERE BLOCKED. THE BLOCKAGE WAS DUE TO EXCESS SOLVENT USED DURING THE ASSEMBLY PROCESS. PRODUCTION HAS BEEN NOTIFIED AND IS RETRAINING ASSOCIATES. THIS ISSUE WAS ALSO CONFIRMED IN HOUSE. CO WAS ABLE TO CONFIRM THIS ISSUE AND TO DETERMINE THE CAUSE. BASED ON THIS INFO CO BELIEVES THAT HIS ISSUE HAS BEEN ADDRESSED AND THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME.
THE PRODUCT WAS USED DURING AN UNSPECIFIED PLASTIC SURGERY. REPORTEDLY, THE SUTURE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HSP HAS REPORTED THAT NO PT INJURY OCCURRED.
1/13/97- SUPPLEMENTAL REPORT #1 SENT TO FDA.
PCA PUMP WAS ADMINISTERING MEDICATION INDEPENDENT OF PT ACTIVATING THE PUMP, CAUSING CONFUSION AND DROWSINESS. ALL SYMPTOMS RELIEVED FOLLOWING REMOVAL OF MALFUNCTIONING PUMP, AND ADMINISTRATION OF NARCAN.
DURING THE PROCEDURE UPON REMOVAL OF THE CATHETER THE SHEATH SEPARATED AT THE HUB. BOTH PIECES WERE SUCCCESSFULLY REMOVED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO IS ANALYSIS.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
USER ENCOUNTERED DIFFICULTY IN REMOVING PROTECTIVE LINER. PADS PULLED APART WHEN USER WAS UNABLE TO REMOVE LINER.
ELECTRODES RETURNED TO MFG. FOR EVAL. EVAL. CONFIRMED THAT INITIAL LINER RELEASE WAS DIFFICULT. CORRECTIVE ACTION IN PLACE.
THERAPEUTIC THORACENTESIS PERFORMED. DURING PROCEDURE (USING ASCEPTIC TECHNIQUE), CATHETER WAS FED INTO THE PLEURAL SPACE. UPON WITHDRAWAL, THE DISTAL END OF THE CATHETER SHEARED OFF (APPROX 6"). STAT CHEST X-RAY CONFIRMED CATHETER WAS IN THE PLEURAL FLUID.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, PNEUMOPERITEUM LEAKED FROM THE DEVICE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. EXPIRATION DATE: 4/30/2001.
WHILE INVESTIGATING A QUESTIONABLE VALUE FOR FEMUR LENGTH ON AN OBSTETRICAL CALCULATIONS REPORT, THE REPORTER FOUND THAT A DIGIT HAD BEEN OMITTED WHEN COMPARED TO THE DATA SAVED IN THE ULTRASOUND SYSTEM. THE DIGIT WAS OMITTED DURING TRANSMISSION OF THE ULTRASOUND DATA TO AN IMAGE AND DATA ACQUISITION SYSTEM. ENGINEERING TESTING HAS CONFIRMED THAT THE PROBLEM OCCURS INTERMITTENTLY AND INFREQUENTLY. THIS MEASUREMENT CAN BE USED IN DETERMINING FETAL WEIGHT AND GESTATIONAL AGE. BASED IN CONSULTATION WITH A PERINATOLOGIST, CO BELIEVES THE CHANCE OF SERIOUS INJURY IS REMOTE.
CO'S ENGINEERING DEPT CONTINUES TO INVESTIGATE THIS PROBLEM TO DETERMINE ITS ROOT CAUSE AND IDENTIFY CORRECTIVE ACTION. THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY OR DEATHS TO DATE. CO DOES NOT BELIEVE THAT IT IS LIKELY THAT A DEATH OR SERIOUS INJURY WILL OCCUR AS DEFINED IN THE FDA REGULATIONS. HOWEVER, TO BE CONSERVATIVE, CO DECIDED IN THE SPIRIT OF THE MDR REGULATIONS TO REPORT THIS MALFUNCTION. CUSTOMERS WILL BE NOTIFIED BY LETTER PENDING AVAILABILITY OF A SYSTEM UP-GRADE THAT CORRECTS THE PROBLEM.
LARGE PIECES OF PLASTIC WERE FOUND IN THE IV TUBING. THE RTR INDICATED THAT THIS HAD OCCURRED ON MULTIPLE OCCASIONS BUT DID NOT PROVIDE SPECIFIC DETAILS.
THE LOT HISTORIES WERE REVIEWED AND WERE FOUND TO BE ACCEPTABLE. RETAIN PRODUCT SAMPLES WERE EVALUATED AND WERE FOUND TO BE ACCEPTABLE. CO WAS UNABLE TO CONFIRM THIS ISSUE WITHOUT BENEFIT OF RETURNED PRODUCT EVAL. CO IS AWARE OF THIS ISSUE FROM A PREVIOUS COMPLAINT. THE PARTICULATE MATTER IS FROM THE MOLDING PROCESS. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED PROCEDURES TO REDUCE PARTICULATE MATTER. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
LINER EXPLODED - WAS BEING USED AND OBVIOUSLY BECAME FULL AND CONTENTS SPIRTED OUT HITTING ROOF OF THEATRE AND CONTAMINATING OR AREA. PT WAS HEPATITIS C, SUCTION WAS NOT TURNED OFF AT WALL OR CONTAINER. ASSUME SHUT OFF MUST HAVE FAILED. POSSIBLY CAME OUT OF TANDEM OR SPECIMEN PORT.
PREVIOUS HISTORY HAS SHOWN THAT THERE WILL BE LOSS OF CONTAINMENT BECAUSE THERE WAS LOSS OF VACCUM INSIDE THE HARD CANISTER BUT NOT INSIDE THE LINER. THIS HAPPENS WHEN THE VACCUM IS TURNED OFF TO THE HARD CANISTER AND THE LINER HAS NOT BEEN PROPERLY CAPPED OFF, OR WHEN THE LINER UNIT POPS OUT OF THE HARD CANISTER CAUSING A LOSS OF VACCUM TO THE OUTSIDE OF THE LINER. CO HAS GIVEN CLEAR STEPS FOR PROPER HANDLING TO DISCARD THE UNIT ON THE INSTRUCTION SHEET INCLUDED WITH THE PRODUCT. CO HAS ALSO DESIGNED THE LID WITH SMALL TABS UNDER THE LID TO HELP HOLD IT IN THE HARD CANISTER SO THAT POP-UP DOESN'T OCCUR. IT IS THE CONCLUSION OF THIS REPORT THAT THERE IS NOT ENOUGH INFO TO TELL WHY THE UNIT SPIRTED FLUID.
THE DEVICE WAS APPLIED DURING A HYSTERECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT HOLD PROPERLY. THE SURGEON APPLIED MANUAL SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PT POSITIONED IN BED WITH BED MONITOR IN PLACE AND SET. DURING ROUTINE ASSESSMENT, PT FOUND INJURED ON THE FLOOR AT THE FOOT OF THE BED. THE ALARM HAD NOT SOUNDED. THE DEVICE WAS EVALUATED BY BIOMEDICAL DEPT WHO DISCOVERED A LOOSE WIRE FROM THE SONALERT TO THE PEGBOARD. SURGERY WAS REQUIRED TO SUTURE THE PT'S RIGHT LIP AND TO STRAIGHTEN AND WIRE A TOOTH.
THE CUSTOMER HAS REPORTED ANOMOLOUS TEMPERATURE READINGS. NO REPORT OF INJURY HAS BEEN REC'D. THE DISTRIBUTOR HAS CONFIRMED THAT THE PT DATA MODULE CABLE SENSOR TO MONITOR CONNECTION WAS BROKEN.
THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENTED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF BIOMEDICAL SENSORS LTD THAT PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE OR WAS CAUSALLY RELATED TO DEATH OR INJURY.
INFLATION OF THE BALLOON CATHETER WAS CONDUCTED AT 8, 12 AND 14 ATMS TO PRE-DILATE THE LESION SITE FOR STENT DEPLOYMENT. UPON REMOVAL OF THE BALLOON CATHETER FROM THE PT, IT WAS NOTED THAT THE PROXIMAL PORTION OF THE BALLON WAS PARTIALLY DETACHED. NO PT INJURY WAS ASSOCIATED WITH THIS INCIDENT. ANOTHER CO BALLOON CATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. TYPE OF EVENT ADDRESSED IN LABELING? (SECTION F10) 1738 FOR CODE 1562. NA FOR CODE 2199. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSPITAL OR DISTRIBUTOR. THE DEVICE WAS RECEIVED FOR EVAL. AND ANALYSIS INDICATED THAT THE PROXIMAL SEAL TO THE BALLOON WAS SEPARATED. THE INNER MEMBER WAS KINKED AT THE SEPARATION. THE BALLOON WAS SUCCESSFULLY INFLATED THREE TIMES PRIOR TO REMOVAL FROM THE PT. THE LAST INFLATION WAS REPORTED TO BE 14 ATMS WHICH INDICATED THAT THE INITIAL SEAL/JUNCTION WAS SOUND. EVAL. OF THE DEVICE INDICATES THAT THE MATERIAL WAS PULL/TORN FROM THE SHAFT. IT IS LIKELY THAT THE BALLOON WAS DAMAGED POSSIBLY THROUGH THE RHV DURING REMOVAL FROM THE PT.
CORONARY STENT INSERTED INTO PROXIMAL AND MID-CIRCUMFLEX ARTERIES IN 8/96. ON 10/7/96, ANGIOPLASTY OF OBTUSE MARGINAL ARTERY PERFORMED. PCTA BALLOON RUPTURED INTO TWO PIECES WITH PROXIMAL PORTION REMAINING IN THE VESSEL. PHYSICIAN PASSED PCTA BALLOON THROUGH THE STENT TO DILATE STENOSIS. PT EVENTUALLY UNDERWENT OPEN CHEST PROCEDURE TO RETRIEVE BALLOON FRAGMENT.
Q2 X-BRACE ASSY. DEALER CLAIMS: BROKEN AT THE BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE MEDIFOLD LEAKED AT THE CHECK VALVE. THIS EVENT OCCURRED AT A HOSP AND WAS REPORTED TO CO BY A DISTRIBUTOR.
THE CUSTOMER RETURNED 59 SAMPLES TO CO FOR EVAL. EXAM OF THE UNITS SHOWED THAT THE CHECK VALVES ON THE SAMPLES FROM THE DEVICES WERE ABLE TO BE BROKEN OFF THE MEDIFOLD WITH LITTLE FORCE. PROCESS RELIABILITY ENGINEERING HAS DETERMINED THAT THE WRONG SOLVENT WAS USED DURING THE MFG PROCESS. PRODUCTION HAS BEEN NOTIFIED. THE SAMPLES FROM THE DEVICE L/N DID NOT BREAK. THE LOT HISTORIES WERE REVIEWED AND WERE FOUND TO BE ACCEPTABLE. CO WAS ABLE TO CONFIRM THIS ISSUE AND TO DETERMINE THE CAUSE. BASED ON INFO, CO BELIEVES THAT THIS ISSUE HAS BEEN ADDRESSD AND THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME.
CONTROL BOX MAIN PG8/50 P1. DEALER CLAIMS WHEELCHAIR WILL TAKE OFF IN CIRCLES SITTING IN NEUTRAL.
NO FAULT FOUND PER EVAL. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT RELFECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ON 8/20/96 DURING APPLICATING OF HUMERAL NAIL PROCEDURE, WHILE DISTAL LOCKING NAIL WITH 3.5MM BONE SCREW, THE HEAD OF SCREW BROKE OFF. SCREW REMOVED ON 8/20/96 AND REPLACED WITH ANOTHER 3.5 CORTICAL SCREW.
H6- REVIEW OF PRODUCTIONS RECORDS. DATA INDICATES THAT ALL PRODUCTS WITHIN THIS LOT WERE MFG IN CONFORMANCE WITH ALL DESIGN REQUIREMENTS. THE DEVICE WAS RETURNED AND IT WAS BROKEN. THIS DEVICE WAS MFG IN 1995.
WHILE UNDERGOING SURGERY, PT DEVELOPED HIGH CO LEVEL OF 49. THE INVOLVED ANESTHESIA MACHINE HAD NOT BEEN USED FOR ABOUT 48 HRS. PT WAS NOT INJURED. ANESTHESIA MACHINE WAS TAKEN OUT OF SVC. IT IS THOUGHT THE HIGH CO LEVEL WAS THE RESULT OF AN INTERACTION BETWEEN THE CO2 ABSORBENT DEVICE AND DESFLURANE.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIMS TUBE BROKE AT THE WELD.
X-TUBE ASSEMBLY 18"X 18". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OF OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO HE REPORTABLE EVENT.
ON OR ABOUT AUGUST 13, 1996, PT WAS IMPLANTED WITH SCREW FOR TREATMENT OF SLIPPED CAPITAL FEMORAL EPIPHYSIS. ON 8/30/96 AT PT 2 WEEK FOLLOW-UP VISIT, DR NOTED BREAKAGE OF SCREW AT THE MID SHAFT. PIECE OF SCREW REMAINS IN PT.
X-TUBE ASSEMBLY 19" X 18". DEALER CLAIMS X-TUBE BROKE AT WELD ON BOTTOM.
WHILE UNDERGOING SURGERY, PT DEVELOPED HIGH CO LEVEL - CARBOXYHGB OF 58. THE INVOLVED ANESTHESIA MACHINE HAD NOT BEEN USED FOR A PERIOD OF 36 TO 48 YRS. THE PT SUFFERED NO UNTOWARD EFFECTS. REPORTS WERE MADE IMMEDIATELY TO THE CO DEPT OF HEALTH. THE ANESTHESIA MACHINE WAS TAKEN OUT OF SVC. A MEDWATCH REPORT WAS IMMEDIATELY MADE TO THE MFR OF THE MACHINE WHO HAS  STATED THAT THE CAUSE OF THE PROBLEM WAS THE CO2 ABSORBER. ONGOING INVESTIGATION HAS RESULTED IN THE CONCLUSION THAT THE EVENT WAS A RESULT OF THE REACTION BETWEEN DRY CO2 ABSORBER AND DESFLURANE. THE CANISTERS OF CO2 ABSORBER INVOLVED HAVE BEEN SENT FOR FURTHER TESTING.
X-TUBE ASSEMBLY 18"X 16". DEALER CLAIMS X-TUBE BROKE AT CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ON 8/27/95 PT WAS IMPLANTED WITH A COMPRESSION HIP SCREW AND PLATE FOR A FRACTURED LEFT HIP. ON OR ABOUT 4/25/95, PHYSICIAN DISCOVERED THAT THE PRODUCT HAD BROKEN.
DEALER CLAIMS AXLE IS BROKEN. DEALER STATES THAT THE BALL BEARINGS FELL OUT OF THE CHAIR. NO INJURY OCCURRED.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING SVC OF PRODUCT A POTENTIAL NO LOW PRESSURE ALARM CONDITION WAS FOUND. CUSTOMER REQUESTED DEVICE BE RETURNED UNREPAIRED. MFR RECOMMENDED THIS UNIT NOT BE USED ON PT UNTIL PROPER REPAIRS HAVE BEEN PERFORMED BY AUTHORIZED PERSONNEL. MFR DISABLED DEVICE PRIOR TO RETURNING IT TO CUSTOMER.
REAR S/F DAB. DEALER CLAIMS FRAME BROKE AT REAR EXTENSION.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING SVC OF DEVICE A CONTINUOUS CYCLE, NO VOLUME DELIVERED, WITH AUDIBLE AND VISUAL ALARMS WAS FOUND, DUE TO 1ST STAGE GEAR BEING OUT OF SPECS. REPLACED 1ST STAGE GEAR.
THE COVER ON THE TOP YOKE HAS SPLIT AND BECOME DETACHED. THIS APPARENTLY CAUSED THE PT TO SLUMP TO ONE SIDE, EVEN THOUGH THIS COMPONENT SHOULD NOT BE USED AS THE HANDGRIP. INJURY WAS NOT SUFFERED BY PT OR CARE ASSISTANT. TWO PEOPLE INVOLVED, NO INJURY.
THIS IS A CLOSE OUT REPORT BY THE FOREIGN REPORTER. INVESTIGATION: IT IS COINCIDENTAL THAT THE PT SLUMPED TO ONE SIDE (NORMAL) AND PART OF THE PROTECTIVE COVER BREAKING OFF. OBSERVATIONS: THE PT WAS NOT USING THAT PART OF THE YOKE AS AN HAND GRIP COMMONLY. CONCLUSIONS: USER ERROR, THIS PT MAY HAVE BEEN AN UNSUITABLE CANDIDATE FOR THIS TYPE OF LIFT. CORRECTIVE ACTIONS: NEW (STRONGER) COVERS HAVE BEEN FITTED TO THIS HOIST.
REPORT OF ALLEGED "SINGLE TONE ALARM, ALL LEDS ON UNIT STOPPED CYCLE. NO PT HARM. UNIT WORKED AFTER IT WAS TURNED OFF AND THEN BACK ON AGAIN.
UNABLE TO OBTAIN ALL INFO REQUIRED IN SECTION F. LABELING # 1738. TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL.
DURING SVC OF PRODUCT, A CONTINUOUS CYCLE, NO VOLUME DELIVERED WITH AUDIBLE AND VISUALS ALARMS WAS FOUND, DUE TO MAGNETIC SENSOR BEING OUT OF SPEC. REPLACED MAGNETIC SENSOR.
REPORT OF ALLEGED "SINGLE TONE ALARM, ALL LEDS ON, MACHINE STOPPED CYCLING. NO PT HARM. PROBABLE LIQUID SPILL".
UNABLE TO OBTAIN ALL INFO REQUIRED SECTION F. LABELING #1738. TESTING BY MFR DID NOT CONFIRM MACHINE STOPPED CYCLING, WITH ALL LEDS AND A SINGLE TONE ALARM. TESTING BY MFR FOUND A CONTINOUS LOW POWER ALARM DUE TO LIQUID SPILL ON LOGIC BOARD AND MOTOR BOARD.
DURING AN UNSPECIFIED PROCEDURE, THE NEEDLE BROKE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
9/18/96 MEDWATCH NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
PORT WAS USED SUCCESSFULLY ON 7/25/96 BUT BY 7/30/96 THE SYSTEM LEAKED. SWELLING WITH ACCESS. FLUSHING STOPPED AND SWELLING DECREASED. SYSTEM WAS HEPLOCKED. SUBSEQUENT LINEGRAM SHOWED TISSUE LEAKAGE, CLOT AT TIP, CONTRAST OUTSIDE OF PORT. EXPLANT OF SYSTEM IS PLANNED BUT IN THE INTERIM PERIPHERAL INFUSION WILL BE USED.
DEVICE WAS RETURNED WITH A 5.5 INCH LENGTH OF CATHETER ATTACHED. MICROSCOPIC EXAMINATION OF THE DEVICE AND CATHETER REVEALED NO ANOMALIES. THE SYSTEM WAS PRESSURIZED VIA NITROGEN FOR ONE MINUTE WITH NO LEAKAGE OCCURRING. THE PORTAL AND CATHETER WERE BOTH PATENT.
FEMORAL HIP HEAD DISLOCATED FROM BIPOLAR LINER DURING A CLOSED REDUCTION PROCEDURE ON 9/16/96. THE SUBJECT FEMORAL HIP HEAD WAS REMOVED ON 9/20/96 ALONG WITH THE BIPOLAR SHELL, 85-8247 MDR REPORT #1219655-1996-0025 AND THE BIPOLAR LINER, 95-8263 MDR REPORT #1219655-1996-0024.
H3 - DIMENSIONAL INSPECTION OF RETURNED HEAD COMPONENT FOUND DEVICE TO MEET SPECIFICATION REQUIREMENTS. REVIEW OF PRODUCTION BATCH RECORDS FOUND LOT TO HAVE MET SPECIFICATION REQUIREMENTS. NO ADDITIONAL INVESTIGATION IS PLANNED.
PD CATH PLACED ON 10/94. NOTED LEAKING MID 9/96. ON EXAM, CATHETER CUFF WAS VISIBLE AT EXIT SITE. CATH REMOVED 9/27/96. SURGEON NOTED CUFF FLOATING FREE OF CATHETER AT REMOVAL. PT ON TEMPORARY HEMODIALYSIS. NEW PD CATH SCHEDULED FOR INSERTION.
FEMORAL HIP HEAD DISLOCATED FROM BIPOLAR LINER DURING A CLOSED REDUCTION PROCEDURE ON 9/16/96. THE SUBJECT BIPOLAR SHELL, ASSEMBLED TO THE BIPOLAR LINER, WAS REMOVED ON 9/20/96 ALONG WITH THE FEMORAL HIP HEAD, 85-3812 MDR REPORT # 1219655-1996-26 AND THE BIPOLAR LINER, 85-8263 MFR REPORT #1219655-1996-0024.
H3 - DIMENSIONAL INSPECTION OF RETURNED SHELL  COMPONENT FOUND DEVICE TO MEET SPECIFICATION REQUIREMENTS. REVIEW OF PRODUCTION BATCH RECORDS FOUND LOT TO HAVE MET SPECIFICATION REQUIREMENTS. NO ADDITIONAL INVESTIGATION IS PLANNED.
PD CATHETER PLACED 5/94. MASSIVE LEAKING OF PD FLUID NOTED 10/3/96, UNRESOLVED BY DECREASED IN PD EXCHANGE VOLUME. PD CATHETER REMOVED SURGICALLY ON 10/9/96. SURGEON NOTED NEITHER INTERNAL OR EXTERNAL CUFF WERE GLUED TO THE CATHETER.
AN ALARM DURING SELF TEST PROCEUDRE DURING SET-UP FOR A PT. ALARM (VENT FAULT 02) INDICATED A DEVICE MALFUNCTION PREVENTING DEVICE USE. THERE WAS NO PT INJURY.
FREQUENCY AND SEVERITY OF THIS EVENT ARE NOT ADDRESSED IN THE DEVICE LABELING AND ARE NOT GREATER THAN USUAL. THE FILING OF THIS REPORT DOES NOT REFLECT A CONCLUSION BY BUNNELL INCORPORATED THAT THE REPORT SHOWS THE DEVICE IS DEFECTIVE, NOR DOES IT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
FOUR VESSEL ARTERIOGRAM BEING PERFORMED. AS CATHETER WAS ENTERING THE LEFT CAROTID ARTERY, THE TIP BROKE OFF. THE PHYSICIAN SUCCESSFULLY SNARED THE TIP FROM THE VASCULAR SYSTEM AND REMOVED SAME. PT SUFFERED NO ILL EFFECTS.
THE DEVICE MFR STATED THAT A CUSTOMER EXPERIENCED A SOFTWARE PROBLEM WHICH RESULTED IN THE PIPETING OF REAGENT FROM THE SAME REAGENT COMPARTMENT REGARDLESS OF TEST REQUESTED. THE DEVICE MFR CONFIRMED THE DEVICE MALFUNCTION. NO REPORTS OF SERIOUS INJURY OR DEATH WERE RECEIVED RELATED TO THE MALFUNCTION,
THE METAL PLUG OF THE ACETABULUM PROSTHESIS WOULD NOT SEAT PROPERLY. NO OTHER INFO WAS PROVIDED TO CO.
FEMORAL HIP DISLOCATED FROM BIPOLAR LINER DURING CLOSED REDUCTION PROCEDURE ON 9/16/96. THE BIPOLAR LINER WAS REMOVED ON 9/20/96. THE BIPOLAR LINER WAS REMOVED ON 9/20/96 ALONG WITH THE FEMORAL HIP HEAD, 85-3812 MDR REPORT 1219655-1996-0026 AND A BIPOLAR SHELL, 85-8247 MDR REPORT #1219655-1996-0025.
H3 - DIMENSIONAL INSPECTION OF RETURNED LINER COMPONENT FOUND DEVICE TO MEET SPECIFICATION REQUIREMENTS. DIMENSIONAL AND CANTILEVER TESTING OF 3 LINER COMPONENTS FROM THE SAME BATCH MET SPECIFICATION REQUIREMENTS. ADDITIONALLY, REVIEW OF PRODUCTION BATCH RECORDS FOUND LOT TO HAVE MET SPECIFICATION REQUIREMENTS. NO ADDITIONAL INVESTIGATION IS PLANNED.
PT WAS IN OR FOR CO2 LASER LARYNGOSCOPY AND BRONCHOSCOPY AND REPLACEMENT OF T-TUBE WHEN THERE WAS SPONTANEOUS COMBUSTION OF AIR IN THE TRACHEA IN THE T-TUBE. T-TUBE WAS IMMEDIATELY REMOVED AND MEDICAL MEASURES INSTITUTED. PT SUSTAINED FIRST DEGREE BURNS OF THE LEFT FVC AND EPIGLOTTIS, AND SMOKE INHALATION. LASER NOT USED AGAIN FOR REMAINDER OF PROCEDURE.
THE STEM EXTENSION COMPONENT APPEARS TO BE DISASSOCIATED FROM THE KNEE TIBIAL PROSTHESIS ON THE POSTOPERATIVE X-RAYS. NO OTHER INFO WAS PROVIDED.
IMPLANT PLACED 7/15/96. HAD TOO MUCH BONE LOSS ON THE BUCKLE. TRIED GRAFTING THE SITE-IT DID NOT HELP. IMPLANT HAD TO BE REMOVED.
AS THE IMPLANT HAS NOT BEEN RETURNED FOR EVALUATION, CO CANNOT BE CETAIN THAT IT IS A CO'S PRODUCT.
NEWBORN ICU HAS REPORTED 8 TO 10 OCCURRENCES OF LEAKAGE AT THE Y-SITE CLOSEST TO THE PT OVER THE LAST FEW DAYS. THERE HAVE BEEN NO REPORTS OF PT PROBLEMS.
REFERENCE METHOD CODE 86, PRESSURE TESTED TO VERIFY LEAKAGE. ONE SET RETURNED AND LEAKAGE REPORT VERIFIED.
PT IN CRIB AND ON VENTILATOR. PT HEARD TO MAKE CRYING SOUNDS AND VENTILATOR ALARM SOUNDED. ON INVESTIGATION, TUBE SHAFT WAS OBSERVED STILL IN PT, BUT PROXIMAL EXTENSION TUBE WAS BROKEN AND CONNECTED TO REST OF SHAFT BY UNCOILED WIRE REINFORCING. TUBE WAS IMMEDIATELY REPLACED AND PT WAS STABLE.
CO RECEIVED 1 PIECE OF A TRACH TUBE, #60PF45, LOT #596870. THE PRODUCT HAS BEEN USED. THE COMPLAINT REPORTER STATES THAT THE PROXIMAL PORTION OF THE SHAFT BROKE. CO EXAMINED THE TRACH AND FOUND THE PROXIMAL PORTION OF THE SHAFT HAD SEPARATED. THE BREAK OCCURRED AT APPROX. THE MID POINT OF THE SHAFT AND NOT AT EITHER BOND SITE. CO COULD NOT DETECT ANY NICK OR CUT THAT MAY HAVE CONTRIBUTED TO THE BREAK. THE REINFORCING WIRE DID NOT BREAK, HOWEVER DID BECOME UNRAVELED ABOUT 8 INCHES. CO CONDUCTED A DESTRUCTIVE TEST ON THE SHAFT TO DETERMINE IF THE SHAFT MAY HAVE BEEN DEFECTIVE. USING THE INSTRON CO DID A TEST TO DETERMINE THE FORCE REQUIRED TO PULL APART THE SHAFT. THE RESULT WAS A FORCE OF 29.4 LBS. THE RESULT WAS WITHIN THE DESIGN PARAMETERS FOR THIS PRODUCT. IT IS APPARENT THAT THE TRACH HAS BEEN SUBJECTED TO A FORCE GREATER THAN WHAT THIS PRODUCT CAN SAFELY WITHSTAND.
VENTILATOR FAILED. PT'S OXYGEN LEVEL DROPPED; PT WAS GIVEN OXYGEN BY AMBU BAG, A NEW VENTILATOR WAS ACQUIRED. NO INJURY TO PT.
THE CUP INSERTER WAS SCREWED INTO THE ACETABULAR SHELL CUP AS PART OF THE PROCEDURE TO FORCE THE CUP INTO THE ACETABULUM. THE CUP INSERTER MAY HAVE STRIPPED THE THREADS OF THE HOLE, THUS CAUSING MISALIGNMENT OF THE APEX HOLE ELIMINATOR INTO THE SHELL.
PRIMED IV TUBING, NOTICED IT WAS LEAKING AT THE PORT SITE CLOSEST TO PT.
REFERENCE METHOD CODE 86, PRESSURE TESTED TO VERIFY LEAKAGE. ONE SET RETURNED.
PT HAD INFUSAPORT IMPLANTED IN LT SUBCLAVIAN VEIN TO FACILITATE CHEMOTHERAPY. BECAME NON FUNCTIONING, AND X-RAY STUDIES INDICATED IT HAD FRAGMENTED, AND DISTAL PORTION LOCATED IN VENA CAVA. IT WAS RETRIEVED PERCUTANEOUSLY WITH CT GUIDANCE.
A 7F PERCUTANEOUS SHEATH INTRODUCED INTO RIGHT INT. JUGULAR VEIN. OBTURATOR INTRODUCED INTO SHEATH & SIDEARM OPENED. NO FLOW THROUGH SIDEARM, SO OBTURATOR REMOVED FROM SHEATH AND FLOW OBTAINED. PLASMAPHORESIS STARTED & 80CC BLOOD REMOVED THROUGH SIDEARMS INTO PLASMAPHORESIS MACHINE. FLOW THROUGH SIDEARM TO MACHINE STOPS - NEGATIVE PRESSURE DEVELOPED IN SYSTEM PROXIMAL TO PUMP COMPRESSION SITE - TUBING COLLAPSES - PLASMAPHORESIS MACHINE PUMP HEAD TURNED OFF. TURBULENCE (AIR) NOTED IN LINE GOINE TOWARD PT; STOPCOCK CLOSED TO PT AND AIR ASPIRATION STARTED VIA STOPCOCK. PT DEVELOPS ST SEGMENT ELEVATION, BRADYCARDIA AND HYPOTENSION. AN INVESTIGATION OF THE INCIDENT REVEALED THAT AIR CAN BE DRAWN INTO THE HEMOSTASIS VALVE WHEN THERE IS NO CATHETER, OBTURATOR OR CAP IN PLACE. FURTHER INVESTIGATION SHOWED THERE WAS NO WARNING ON LABEL OR INSTRUCTION RE: POSSIBLE ASPIRATION OF AIR INTO SHEATH WHEN THERE IS NO CAP ON SHEATH INLET SITE WITH THE HEMOSTASIS VALVE.
LINER BECAME JAMMED IN METAL ACETABULAR CUP. WHEN REMOVED, THE TRIAL LINER TURNED THE METAL ACETABULAR CUP AS WELL.
IMPLANT FAILED TO INTEGRATE. EXACT DATE OF OCCURRENCE IS UNK.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
THE PHYSICIAN HAD PLACED THE SHEATHLESS STENT IN THE PT WITH THE BALLOON. THE DEVICE WAS AT THE SITE OF THE LESION AND HAD BEEN TESTED BY THE PHYSICIAN TO ENSURE PROPER PLACEMENT. HE WAS PREPARING TO INFLATE WHEN THE GUIDE CATHETER FLIPPED OUT INTO THE AORTA AND THE STENT CAME WITH IT BUT CAME OFF OF THE BALLOON. THE STENT REMAINS IN THE PT. FURTHER TESTING IS TO BE CONDUCTED IN AN EFFORT TO LOCATE THE POSITION OF THE DEVICE.
DISCLAIMER: B.BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED 12/11/95. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CASUAL RALATIONSHIPS TO DEVICES MANUFACTURED OR DISTRIBUTED BY B.BRAUN MEDICAL INC.
THE DEVICE WAS BEING USED TO LIFT A PT THAT WAS TO BE MOVED TO THE MORTUARY. THE PHYSIOTHERAPISTS WERE UNABLE TO FINISH THE LIFT AS THE WINDING MECHANISM FAILED TO RAISE THE BOOM.
THIS IS A CLOSE OUT BY THE FOREIGN REPORTER. INVESTIGATION: IT WAS FOUND THAT THE BOTTON STOP ON THE BALL SCREW ASSEMBLY HAD SHEARED CAUSING LOSS OF THE BALL BEARINGS. CONCLUSIONS: THIS WAS CAUSED BY THE DEVICE BEING OVER WOUND ON DOWN TRAVEL, SHEARING THE TENSION PIN AND LOSING BALLS FROM THE DRIVE ASSEMBLY. CORRECTIVE ACTIONS: A NEW SCREW AND DRIVE ASSEMBLY HAVE BEEN FITTED. REPORT NUMBER -828100.
THE PT WAS UNDERGOING OPEN HEART SURGERY. THEY WERE READY TO REMOVE THE PT FROM BYPASS AND ATTEMPTED TO RESTART THE PT'S HEART USING INTERNAL PADDLES. THE DEFIB WAS TURNED ON AND CHARGED TO THE SELECTED SETTING. THE READY TONE SOUNDED BUT WHEN THEY ATTEMPTED TO DISCHARGE THE DEFIB, A "SYSTEM FAILURE" MESSAGE OCCURRED ON THE SCREEN. THEY ATTEMPTED TO TURN THE DEFIB ON AND OFF SEVERAL TIMES, BUT IT FAILED AT THE SAME POINT EACH TIME. THE BIOMED THEN BROUGHT IN THE BACKUP DEFIB TO RESTART THE PT'S HEART. THE PT WAS SUCCESSFULLY RESUSCITATED.
THE SYSTEM BOARD HAD A FAILURE THAT OCCURRED EVERY TIME. THE SYSTEM BOARD WAS REPLACED AND THE UNIT TESTED. IT HAS BEEN PLACED BACK IN SERVICE IN SURGERY.
IMPLANT DID NOT INTEGRATE. EXACT DATE OF OCCURRENCE IS UNK.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE A 3.75 X 13 SELF-TAPPING IMPLANT, NOT THE REPORTED 3.75 X 15 SELF-TAPPING IMPLANT. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANTS IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
THE PORT WAS IMPLANTED ON 8/2/96 ON THE PT'S RIGHT SIDE FOR CHEMOTHERAPY. ON 8/5/96, EXTRAVASATION OF CHEMOTHERAPY FROM THE PORT WAS REPORTED TO HAVE OCCURRED. THE PORT WAS REMOVED AND THE TISSUE WAS DEBRIDED.
THIS MEDWATCH IS BEING UPDATED TO INCLUDE A REPORT SENT TO US BY THE USER FACILITY.
PT HAD LEFT PARIETAL VENTRIBULO-PERITONEAL SHUNT PLACED AT AGE 9 MONTHS. ONE WEEK PRIOR TO ADMISSION, PT DEVELOPED HEADACHES, DIPLOPSIA AND DIMINISHED VISION. CT SCAN REVEALED PROGRESSIVE VENTRICULAR ENLARGEMENT. EXAMINATION SUGGESTED A PROXIMAL SHUNT OBSTRUCTION REQUIRING REMOVAL AND REPLACEMENT OF SHUNT.
THE PHYSICIAN ATTEMPTED A RIGHT JUGULAR APPROACH FOR VENA CAVA FILTER PLACEMENT WITHIN THE IVC BELOW THE LEVEL OF THE RENAL VEINS AND DEPLOYED THE FILTER IN THE GONADAL VEIN. THE PHYSICIAN STATED THAT THERE WAS ONLY A SHORT SPACE BETWEEN THE RENAL VEIN AND THE GONADAL VEIN. HE THEN SNARED THE FILTER AND PULLED IT BACK INTO THE IVC, BUT WAS UNABLE TO RE-DEPLOY THE FILTER WITHIN THE IVC. THE PHYSICIAN THEN PULLED THE FILTER UP TO THE JUGULAR VEIN AND SENT THE PT TO THE OR FOR A SURGICAL CUT-DOWN TO REMOVE THE FILTER. A SECOND FILTER WAS SUCCESSFULLY PLACED. THE PT REMAINS STABLE AND SUFFERED NO ADVERSE EFFECTS FROM THE PROCEDURE.
DISCLAIMER: B.BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, VOLUME 49, RELEASE NUMBER 180, DATED FRIDAY SEPTEMBER 14, 1984, SECTION 803 (MEDICAL DEVICE REPORTING) SUBSECTION 803.24. B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR AN CAUSAL RELATIONSHIPS TO DEVICE MANUFACTURED OR DISTRIBUTED BY B.BRAUN MEDICAL INC.
WHEN THE PT WENT INTO ASYSTOLE, THE SYSTEM DID NOT ALARM AUDIBLE. THE CUSTOMER SAID THE PT DIED, BUT STATED THE MONITOR DID NOT CAUSE THE DEATH. THE NURSING STAFF WAS AWARE OF THE PT'S CONDITION, BUT THEY FELT THE SYSTEM DID NOT ALARM CORRECTLY.
CO'S CE WENT TO THE CUSTOMER'S SITE. HE SIMULATED WHAT TOOK PLACE DURING THE INCIDENT AND FOUND EVERYTHING TO BE WORKING PERFECTLY. IT'S POSSIBLE THAT THE ALARM WAS IN A REFRACTORY PERIOD OR THE ALARM VOLUME WAS TURNED COMPLETELY DOWN. THE CUSTOMER ERASED ALL PT ALARM HISTORY WITH THE DISCHARGE OF THE PT. IT APPEARS THAT THE MED CTR STAFF NEEDS SOME TRAINING ON HOW ARRHYTHMIA FUNCTIONS WORK. STAFF WILL BE TRAINED BY A CO'S CLINICAL SPECIALIST.
NO FURTHER INFO FROM DR IS AVAILABLE AT THIS TIME. CONDITION RECEIVED: USED. INVESTIGATION: IMPLANT UP TO SPECS. ANALYSIS SUMMARY: NOT ATTRIBUTED TO PRODUCT. CORRECTION ACTION: NONE AS CO CAN NOT CRITIQUE DR'S TECHNIQUES IN HIS OPERATORY. PREVENTIVE ACTION: NONE.
WHEN ENGINEER CALLED TO REPAIR A FAULT IT WAS REPORTED TO HIM THAT THE MAST HAD SWUNG ROUND CAUSING A MALE PT TO FALL BACK ONTO BED AS HE WAS BEING LIFTED. NO PERSON INVOLVED NO INJURY.
ON INSPECTION THE ENGINEER FOUND THE INNER MAST GUIDE BLOCK WELD HAD FAILED. THIS UNIT HAD BEEN OVER LOOKED DURING UPGRADE SVC FOR THE INNER MAST. THE ENGINEER TOOK THIS UNIT OUT OF SVC AND A WORK ORDER WAS INITIATED ON 9/27/96. THE INNER MAST UPGRADE HAD BEEN COMPLETED, UNIT IS HAS NOW BEEN PLACED BACK INTO SVC. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT, THAN IS USUAL? YES. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED INT HE DEVICE LABELING? NO. IF NO THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? YES. ADD'L INFO PROVIDED AFTER 15 DAY REPORT NO. DISCLAIMER: THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT. NEITHER THE SUBMISSION OF THIS, OR OTHER INFO, TO THE FDA PURSUANT TO 21 CFR600, 803,1002 AND 1003, NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
NO FURTHER INFO AT THIS TIME IS AVAILABLE. CONDITION RECEIVED: USED. INVESTIGATION: IMPLANT UP TO SPECS. ANALYSIS SUMMARY: NOT ATTRIBUTED TO PRODUCT. CORRECTIVE ACTION: NONE AS CO CAN NOT CRITIQUE DR'S TECHNIQUES IN HIS OPERATORY. PREVENTATIVE ACTION: NONE.
HC WAS STARTING AN IV USING THE IV CATHETER. THE NEEDLE WAS PULLED BACK (STYLET) AND THE PROTECTIVE SHEATH COVERED THE STYLET AND LOCKED IN PLACE. A SMALL PORTION OF THE TIP WAS PROTRUDING BEYOND THE PROTECTIVE SHEATH AND STUCK THE HC.
THE DEVICE WAS REMOVED DUE TO A "PUMP MALFUNCTION." THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED WITH ANOTHER COMPONENT. 10/4/96 OPERATIVE REPORT WAS OBTAINED FROM THE PHYSICIAN/SURGEON'S OFFICE. AS STATED "INCISION WAS MADE OVER THE SCROTUM AND CARRIED DOWN TO EXPOSE THE PUMP MECHANISM OF THE PROSTHESIS AND A LEAK WAS SEEN IN THE TUBING FROM THIS PROSTHESIS. THE NEW PUMP MECHANISM WAS PLACED AND CONNECTED WITH STRAIGHT SNAP-LOCK CONNECTORS."
EVALUATION AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE COMPONENT(S). FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVALUATION WILL BE FORWARDED UPON COMPLETION.
DR REPORTS AFTER IMPLANTATION THE LENS BECAME COATED WITH CELLS AND A WHITE MEMBRANE. PRECIPITATE WAS OBSERVED IN THE VITREOUS. THE LENS WILL BE EXPLANTED AND A VITRECTOMY PERFOMED. THE DR PERFOMED 5 SURGERIES ON 28 AUG 96 AND 2 HAD THIS OUTCOME.
ADD'L INFO HAS BEEN SOUGHT. THE LENS HAD NOT BEEN REMOVED AT THE TIME OF THIS REPORT THEREFORE NO EVALUATION COULD BE PERFORMED. THERE WERE NO SIMILAR COMPLAINTS FOR THIS LOT. THIS REPORT WAS MAILED IN TO FDA ON: 10/16/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
LEAKING PENILE PROSTHESIS REQUIRING SURGICAL REPLACEMENT.
THE BOLT AND NUT LOOSENED IN THE VERTICAL ARM MOUNT. THIS CAUSED THE ARM TO DROP 1 1/2 TO 2 FEET. THE VELCRO STRAPS PREVENTED A TOTAL FALL. NO INJURIES OCCURRED.
THE HEXAGON NUT THAT ATTACHES TO THE SOCKET CAP SCREW IN THE VERTICAL ARM LOOSENED. WHEN THE NUT LOOSENED, THE VERTICAL ARM ASSEMBLY THAT HOLDS THE INJECTOR HEAD DROPPED 1 1/2 TO 2 FT, SUSPENDED AND PREVENTED FROM TOTAL FALL BY VELCRO STRAPS. CAUSE FOR THIS IS UNKNOWN. THE MFR WILL BE NOTIFIED AND ANY NECESSARY CORRECTIVE ACTION PURSUED.
THE PT WAS BEING TRANSPORTED FROM HOSP. APPROX 2 HOURS INTO THE TRIP THE IABP SCREEN FROZE UP BUT THE PUMP CONTINUED TO FUNCTION. POWER WAS RECYCED AND THE CONSOLE CAME UP OK BUT APPROX. 15 MUNITES LATER THE SAME THING HAPPENED. IT HAPPENED A THIRD TIME. THE CONSOLE WAS DISCONNECTED AND THE BALLOON WAS MANUALLY INFLATED AND DEFLATED APPROXIMATELY EVERY 10 MINS AT 50CC. THERE WERE NO PT COMPLICATIONS.
MFR CONTROL NO DI96-217. THE CO FIELD SVC REP INVESTIGATED THIS INCIDENT. THE MOTHER BOARD, THE F1 AND F2 FLOW PANELS, THE GRAPHIC PCB, AND THE BALLOON CONNECTOR WERE REPLACED. THE PUMP WAS TESTED FOR 1 1/2 HOURS AND RAN NORMALLY.
DR WAS NOT GETTING ASPIRATION DURING PROCEDURE. THE CASSETTE WAS REPLACED AND A GRINDING NOISE OCCURRED. FELT THAT THE LACK OF ASPIRATION/FLUID FLOW CAUSED PROBLEM. DURING FIELD ENGINEER'S VISIT ON 9/16/96 THE CUSTOMER STATED THAT A POSSIBLE IRIS INJURY TO PT OCCURRED ON 9/11/96 AS A RESULT OF THIS EVENT.
PT HAD NOT RETURNED TO USER FACILITY AT THE TIME THEIR REPORT WAS SUBMITTED.
TIBIAL COMPONENT WAS REMOVED AND A TIBIAL BASEPLATE WITH A INSERT WAS USED. A STEM EXTENSION OF 155 MM WAS USED. TIBIA STARTED TO FAIL IN THE LATERAL ASPECT BECAUSE OF SOFT BONE.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE,
9/18/96-MEDWATCH REPORT WAS NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
DR REPORTS AFTER IMPLANTATION THE LENS BECAME COATED WITH CELLS AND A WHITE MEMBRANE. PRECIPITATE WAS OBSERVED IN THE VITREOUS. THE LENS WILL BE EXPLANTED AND A VITRECTOMY PERFORMED. THE DR PERFORMED 5 SURGERIES ON 28 AUG 96 AND 2 HAD THIS OUTCOME.
ADD'L INFO HAS BEEN SOUGHT. THE LENS HAS NOT BEEN REMOVED FROM THE EYE THEREFORE NO EVAL. COULD BE PERFORMED. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED ON THIS LOT. THIS REPORT WAS MAILED IN TO FDA ON: 10/16/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TOBE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE, THE INSTRUMENT DID NOT FIRE. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING AN INVESTIGATION INTO A SUBSEQUENT EVENT, A PREVIOUSLY UNREPORTED EVENT WAS DISCOVERED. THE DEVICE WAS REMOVED AS THE PT WAS "UNABLE TO PUMP PENILE PROSTHESIS". 11/6/96-UPON RECEIPT OF THE MD/SURGEONS OPERATIVE REPORT, IT STATED,..."UNABLE TO PUMP PENILE PROSTHESIS AND MALFUNCTION OF THE PROSTHESIS". THE SURGERY ENTAILED, "REPOSITION THE PUMP, PERFORM CORPOROTOMY AND SHORTEN PROSTHESIS. INCISION OF PEYRONIE'S PLAQUES". DURING THE PROCEDURE THE OPERATIVE REPORT STATED,..."I EXPOSED THE CYLINDER(S) AND FOUND THAT THEY WERE FOLDED UPON THEMSELVES. I REMOVED THE CYLINDER(S) AND REMOVED ONE REAR-TIP EXTENDER ON EACH SIDE, REPLACED THE CYLINDER(S) AND THERE WAS EXCELLENT PLACEMENT OF THE PROSTHESIS. THE PUMP WAS REPOSITIONED TO A MORE DEPENDENT POSITION IN THE MID TO LEFT HEMISCROTUM. IT WAS PEYRONIE'S DISEASE AND MALFUNCTION OF PENILE PROSTHESIS SECONDARY TO SHORTENING OF THE CORPORAL BODIES"."
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 8/5/94 AND REVISED ON 1/11/96 BECAUSE THE PATIENT WAS "UNABLE TO PUMP (THE) PENILE PROSTHESIS." IN THE RECEIVED INFO THE PHYSICIAN STATED THAT "I THEN EXPOSED THE CYLINDERS AND FOUND THAT THEY WERE FOLDED UPON THEMSELVES. I REMOVED THE CYLINDERS AND REMOVED ONE REAR TIP EXTENDED ON EACH SIDE, REPLACED THE CYLINDERS AND THERE WAS EXCELLENT PLACEMENT OF THE PROSTHESIS." THE PHYSICIAN FURTHER STATED THAT "IT WAS PEYRONIE'S DISEASE AND MALFUNCTION OF PENILE PROSTHESIS SECONDARY TO SHORTENING OF THE CORPORAL BODIES." IN ADDITION THE PUMP WAS REPOSITIONED "TO A MORE DEPENDENT POSITION." BECAUSE REAR TIPS ONLY WERE REMOVED AND NOT RETURNED, QA CANNOT COMMENT ON THEIR CONDITION. HOWEVER, BECAUSE QA'S EXAMINATION CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF "SHORTENING OF (THE) CORPORAL BODY," OR "MALPOSITION OF PENILE PROSTHESIS PUMP," AND BECAUSE THE DEVICE REMAINS IMPLANTED AS IS FUNCTIONING AS INTENDED, QA ACCEPTS THE PHYSICIAN OBSERVATIONS OF SUCH AS THE REASONS FOR SURGICAL INTERVENTION. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
THE CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS CORE ASSAY, THE SAMPLE HANDLER FAILED TO PIPETTE SAMPLE AND DILUENT INTO POSITIONS A6 AND B6 AND DID NOT GIVE AN ERROR MESSAGE. AN ENGINEER HAS BEEN DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
BACKFLOW WAS NOTED FROM THE SECONDARY LINE INTO THE PRIMARY LINE. THERE WAS NO RESULTANT PT COMPLICATION.
THE SAMPLE WAS RECEIVED AND EVALUATED AND NO BACKFLOW WAS NOTED. ALTHOUGH THE BACKFLOW COULD NOT BE DUPLICATED WHEN THE CHECK VALVE WAS EXAMINED PARTICULATE WAS NOTED INSIDE THE VALVE BUT NOT ON THE SEALING SURFACE. IT IS SUSPECTED THAT THE PARTICULATE MAY HAVE CAUSED THE BACKFLOW AND THEN MAY HAVE BEEN WASHED THROUGH THE CHECK VALVE DURING THE ANALYSIS. THE MFR OF THE CHECK VALVE HAS BEEN NOTIFIED OF THE ISSUE OF PARTICULATE. CHANGES HAVE BEEN MADE TO THE MFG AND ASSEMBLY PROCESS TO REDUCE THE LIKELIHOOD OF PARTICULATE BEING INTRODUCED INTO THE CHECK VALVE DURING MFG. SECTIONS A,B, AND F WERE COMPLETED BY THE MFR. SECTION B-4,6,7 AND F-2,6,8,10 IS UNKNOWN BECAUSE THE INFO WAS NOT RECORDED AT THE FACILITY SINCE THERE WAS NO PT INJURY. SECTION D-6 LOT NUM LIST THREE #'S. LOT #605612 IS THE SUSPECTED LOT NUMBER AND THAT LOT# DATE OF MFG WAS USED IN SECTION H-4. MFR'S REPORT DATE 10/3/96. FILE#09-96-18.
THE PT HAD AN EMERGENCY CABG AFTER A FAILED ANGIOPLASTY. WHILE ON THE PUMP, THE USER WAS UNABLE TO OBTAIN LEAD II AND III. THE USER WAS ALSO HAVING PROBLEMS WITH ARTERIAL PRESSURE TRIGGERING. WHEN THEY WENT TO ARTERIAL PRESSURE TRIGGERING, IT APPEARED THAT THE PUMP WAS STILL USING ECG TRIGGERING. THE USER CHANGED PUMP CONSOLES, AND THE PROBLEM WAS CORRECTED.
MFR CONTROL NO DI96-215. THE CO'S FIELD SVC REP INVESTIGATED THIS INCIDENT. HE REPLACED THE FRONT END A BOARD, AND TESTED TRIGGERING IN ALL LEAD AND CONFIGURATIONS. THE PUMP WAS THEN CHECKED OUT AND RAN NORMALLY.
HOSPITAL REPORTS THE LENS WAS INSERTED AND THEN REMOVED DUE TO ZONULAR DEHISCENCE AND A NON-INTACT CAPSULAR BAG. THE HAPTIC WAS NOTICED TO BE BROKEN UPON REMOVAL FROM EYE.
NO ADD'L INFO HAS BEEN RECEIVED DESPITE REQUEST. THE RETURNED LENS WAS OBSERVED TO HAVE A BROKEN HAPTIC. THERE WAS NO INDICATION THAT THE BROKEN HAPTIC WAS CITED AS THE CAUSE OF THE REPORTED EVENT. IT IS POSSIBLE THAT THE HAPTIC WAS BROKEN UPON REMOVAL FROM THE EYE. THIS REPORT WAS MAILED IN TO FDA ON: 10/16/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
A MALE PT UNDERWENT HARTMANN'S PROCEDURE. THE SUTURE WAS USED IN CONTINUOUS FASHION FOR CLOSURE OF THE FASCIA OF A MIDLINE INCISION. APPROX ONE WEEK POST-OPERATIVELY, THE PT COUGHED EXTENSIVELY, AND AT THIS POINT THE PT DEVELOPED WOUND DEHISCENCE. REOPERATION WAS NECESSITATED. AT RE-EXPLORATION, SUTURE WAS NOTED TO BE BROKEN IN THE STRAND, AND THE KNOTS WERE INTACT. SUBSEQUENTLY, DOUBLE LOOPED POLYPROPYLENE SUTURE WITH THE ADDITION OF A RETENTION SUTURE WAS USED FOR THIS CLOSURE. THE PT HAS BEEN DOING WELL POST REOPERATION. DR ADMITS THAT THE PT HAD A HEAVY BODY WEIGHT AND SHE SHOULD NOT HAVE USED A SIZE 2 SUTURE FOR THIS TYPE OF PROCEDURE; DUE TO THE FACT THAT THERE WAS NO SIZE 2 SUTURE IN THE OPERATING ROOM AT THE TIME, SHE RELUCTLANTLY USED SIZE 0 SUTURE.
SAMPLES FROM THE SAME LOT WERE RETURNED AND EVALUATED. KNOT PULL STRENGTH, HYDROLYTIC AND IN-VIVO TESTS WERE PERFORMED. ALL RESULTS WERE SATISFACTORY. LOT HISTORY REVIEW REVEALED NO DEFECTS RELATED TO THE PROBLEM REPORTED. NO OTHER REPORTS HAVE BEEN RECEIVED AGAINST THIS LOT. THE DR USING THE SUTURE REPORTED SHE SHOULD NOT HAVE BEEN USED "0" SUTURE ON SUCH HEAVY PT. HOWEVER, NO "2" SUTURE WAS AVAILABLE AT THE TIME, SO SHE RELUCTANTLY USED "0" SUTURE. SHE FEELS SUTURE WAS TOO LIGHT FOR THE PT. CO'S TEST RESULTS SUPPORT HER FEELING. THE SUTURE SHOULD HAVE WORKED AS EXPECTED.
DURING AN UNSPECIFIED PROCEDURE, THE SUTURE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE CUSTOMER REPORTED THAT WHILE RUNNING AN HCV ASSAY, THE SAMPLE HANDLER PIPETTED SAMPLES FROM ROW C INTO ROW D. NO ERROR MESSAGE WAS GENERATED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
PRIOR TO USE ON A PT, THE CONSOLE FAILED SELF TEST. THE PROBLEM WAS FOUND TO BE WITH A TRANSDUCER. THE COMPONENT WAS REPLACED. THERE WAS NO IMPACT TO THE PT. THE COMPONENT HAS BEEN RETURNED TO CO FOR EVAL.
PNEUMOTHORAX DEVELOPED AFTER ATTEMPTED PLACEMENT. PT WAS INTUBATED AND ON A VENTILATOR. CHEST TUBE INSERTED-PT IS OKAY.
INVESTIGATION IS IN PROCESS, AWAITING MORE INFO FROM CUSTOMER. REFERENCE MFR COMPLAINT #V96-9-25-195. SECTION H-3- UNUSED DEVICES FROM CUSTOMERS INVENTORY RETURNED AND VISUALLY EXAMINED. NO PROBLEMS OBSERVED. IT HAS NOT BEEN ESTABLISHED IF THE REPORTED PROBLEM OCCURRED WHEN USING PRODUCT FROM EITHER OF THE RETURNED LOTS. ACTUAL LOT NUMBER UNKNOWN. (CODES 100 AND 81 IN EVALUATION REPORT.) PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO AND THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
AFTER LOADING THE TUBING INTO THE PUMP AND RELEASING THE ROLLER CLAMP ON THE SET THE NURSE NOTICED EXCESSIVE FLUID FLOW IN THE DRIP CHAMBER. PUMP WAS REMOVED FROM USE. THERE WAS NO RESULTANT PT COMPLICATION.
THE PUMP WAS RETURNED AND WAS VISUALLY AND FUNCTIONALLY TESTED AND FOUND TO MEET ALL MFRS SPECIFICATION. THERE WAS NO VISUAL DAMAGE NOTED. THE ACCURACY WAS TESTED AT SEVERAL RATES AND PASSED ALL TESTS. IT IS SUSPECTED THAT A POSSIBLE MISLOAD OF THE IV SET MAY HAVE CAUSED THE REPORTED OVERINFUSION. ADD'L INSERVICING HAS BEEN SCHEDULED ON PROPER LOADING OF THE IV SET PER THE DIRECTIONS FOR USE. SECTIONS A,B,D, AND F WERE FILLED OUT BY THE MFR. SECTION A-4 PT'S WEIGHT UNKNOWN. SECTION B-4,6,7, AND F-2,6,8,10,13 ARE NOT COMPLETED SINCE THE USER FACILITY DID NOT FILE A REPORT. MFR'S REPORT DATE 10/3/96 FILE #9-96-20.
DURING PT SUPPORT, THE CONSOLE STARTED HAVING REDUCED PUMP FLOW. A BACK UP CONSOLE WAS USED WITH NO PROBLEM TO THE PT. THE ISSUE IS CURRENTLY BEING INVESTIGATED.
DR REPORTS CAPSULE TORE DURING PROCEDURE "THE PT HAD AN INTACT POSTERIOR CAPSULE AND ANTERIOR CAPULORRHEXIS PRIOR TO IOL INSERTION. ONE HAPTIC WAS PLACED IN THE BAG BUT THE OTHER HAPTIC WOULD NOT ROTATE INTO THE BAG WITH EASE. WHEN THE SECOND HAPTIC WAS FINALLY ROTATED INTO THE BAG THE POSTERIOR CAPSULE BREAK WAS NOTED WITH VTREOUS LOSS. THE LENS WAS REMOVED AND AN ANTERIOR CHAMBER LENS WAS PLACED".
THE DR REPORTS HE IS UNCERTAIN OF RELATIONSHIP OF EVENT TO LENS. THE RETURNED LENS WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATIONS WITH NO DEFECTS. THIS REPORT WAS MAILED IN TO FDA ON: 10/16/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
ONE WEEK AFTER SETTING OF STAPLES, BLOTCHED AND LOCAL INFLAMMATION DEVELOPED, NECESSITATING WITHDRAWAL OF THE STAPLES SOONER THAN FORECASTED.
INVESTIGATION IS IN PROGRESS. REFERENCE MFR COMPLAINT #G96-176. RE: SECTIONS D-3, D-6, F-10 AND G-1; THE EXACT MFG PLANT AND CO PROVIDED TO CO WAS ASSIGNED BY A FOREIGN OFFICE, NOT BY THE MFG PLANT. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO  NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
DURING CLINICAL INSERVICING, THE FOOT PUMP TUBING WAS KINKED FROM IMPROPER HANDLING. THE TUBING WAS REPLACED AND THE STAFF AT THE HOSP WAS INSERVICED ON THE PROPER USE OF THE FOOT PUMP.
THE PUMP OVERINFUSED AND THE PT RECEIVED AN OVERDOSE OF MEDICATION. SYRINGE WAS FILLED. AFTER FOUR HRS THE NURSE RESPONDED TO A LOW VOLUME ALARM AND THE SYRINGE WAS EMPTY. THERE WAS NO PT COMPLICATION.
THE PUMP WAS RETURNED AND COMPLETE VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND NO FAULT WAS FOUND. THE PUMP WAS FOUND TO MEET ALL MFR'S SPECIFICATION. SECTION A-1,B,D,AND F WAS FILLED OUT BY THE MFR. SECTION F-2,10,7,8, UNKNOWN. FILE #08-96-167. MFR'S REPORT DATE 9/27/96.
PT CODED AND BEGAN VOMITING. PHYSICIAN ATTEMPTED INTUBATION. SUCTION WAS CONNECTED, OPERATED PROPERLY FOR A SHORT TIME, THEN FLUTTER VALVE SEALED OFF CAUSING SUCTION TO MALFUNCTION. PT EXPIRED BUT DEATH IS NOT ATTRIBUTED TO THE MALFUNCTIONING SUCTION CANISTER.
PT CODED AND BEGAN VOMITING. PHYSICIAN ATTEMPTED INTUBATION. SUCTION WAS CONNECTED, OPERATED PROPERLY FOR A SHORT TIME, THEN FLUTTER VALVE SEALED OFF CAUSING SUCTION TO MALFUNCTION. PT WXPIRED, BUT DEATH IS NOT ATTRIBUTED TO THE MALFUNCTIONING SUCTIONING CANISTER.
HOSPITAL REPORTS DR HAD TO WIDEN WOUND IN ORDER TO REMOVE LENS AT IMPLANTATION PROCEDURE. REASON FOR REMOVAL NOT PROVIDED.
NO ADD'L INFO HAS BEEN RECEIVED DESPITE REQUEST. THE RETURNED LENS WAS COVERED WITH BLOOD AND CLINICAL SOLUTION AND HAD ONE BROKEN HAPTIC. IT IS UNKNOWN IF HAPTIC WAS BROKEN PRIOR TO OR AFTER REMOVAL FROM THE EYE. NO REASON HAS BEEN PROVIDED AS TO WHY THE LENS WAS REMOVED FROM THE EYE. THIS REPORT WAS MAILED IN TO FDA ON: 10/16/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC.PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE CARTRIDGE DISENGAGED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
10/15/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. CO'S FOREIGN SUBSIDIARY WAS INFORMED OF THIS EVENT ON 8/27/96. HOWEVER, CORPORATE WAS NOT INFORMED UNTIL 10/3/96. CO'S FOREIGN SUBSIDIARY WILL BY RE-INSTRUCTED REGARDING THE MDR REGULATION.
LABELS STATES TROUBLESHOOTING INFO FOR PREMATURE SHUT-OFF AS SUCH: "THE SHUT-OFF VALVE IS ANGLE SENSITIVE. IT IS DESIGNED TO SHUT VACUUM IF THE UNIT IS INADVERTENTLY PULLED OVER OR BUMPED. IF VACUUM IS STOPPED, SIMPLY DISCONNECT THE VACUUM SUPPLY AT THE VACUUM PORT ON THE LID AND ALLOW THE VALVE TO MOVE BACK INTO THE OPEN POSITION.
DR REPORTS LENS REPLACEMENT DUE TO PT SEEING LINES THROUGH CENTER VISION.
NO ADD'L INFO HAS BEN RECEIVED DESPITE REQUEST. THE EXPLANTED LENS WAS SENT TO DR. AS OF 10/15/96 THE MFR HAD NOT RECEIVED EVAL. RESULTS. THIS REPORT WAS MAILED IN TO FDA ON: 10/16/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABRORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE PUMP RAN CONTINUOUSLY WITHOUT BEING PROGRAMMED IN THE CONTINUOUS MODE. THERE WAS NO RESULTANT PT COMPLICATION.
THE INSTRUMENT WAS RECEIVED AND VISUALLY AND FUNCTIONALLY TESTED. THERE WAS NO PHYSICAL DAMAGE NOTED AND THE INSPECTION SEAL WAS INTACT. FUNCTIONAL TESTING WAS PERFORMED AND WAS FOUND TO MEET MFR'S SPECIFICATIONS. ACCURACY TESTING WAS PERFORMED AT SEVERAL DIFFERENT TIMES AND PASSED ALL TESTING. NO FAULT FOUND WITH THE PUMP. UNABLE TO DETERMINE CAUSE FOR THE REPORTED OVERINFUSION. FINAL REPORT DATE 11/5/96.
THE DEVICE WAS REMOVED DUE TO "BROKEN PUMP." THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 2-PIECE INFLATABLE PENILE PROSTHESIS. 10/8/96 RECEIVED INFO FROM THE PHYSICIAN'S OFFICE WHICH STATED "TUBE FAILURE AT RESIPUMP."
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 3/9/93 AND REMOVED ON 9/23/96 DUE TO A "BROKEN PUMP." A RESIPUMP, TWO CYLINDERS, AND FOUR REAR TIP EXTENDERS WERE RETURNED FOR EVALUATION. IN THE RECEIVED INFO THE PHYSICIAN NOTED A "TUBE FAILURE" AT THE RESIPUMP. THE PHYSICIAN FURTHER STATED THAT THERE WERE NO APPARENT CIRCUMSTANCES OR INFO IN THE PT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A SEPARATION, POSTERIORLY LOCATED IN OUTLET #2'S EXITING TUBE NEAR THE STRAIN RELIEF/TUBE JUNCTION. EXAMINATION OF THE SURFACES OF THE SEPARATION REVEALED MARKINGS CHARACTERISTIC OF STRESS(S) INDUCED RENDING. AN AREA OF ABRASION IS NOTED SURROUNDING AND PENETRATING THE SEPARATION SITE. ADJACENT TO THE AREA OF ABRASION A CREASE MARK IS NOTED. BASED ON QA'S EXAMINATION AND THE PHYSICIAN'S OBSERVATIONS, QA CONCLUDED THAT WHILE IN-VIVO, OUTLET #2'S EXITING TUBE WAS PARTIALLY KINKED AND ABRADING AGAINST ITSELF. QA FURTHER CONCLUDED THAT THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBING AT THIS SITE.
PER THE PT'S AUDIOLOGIST, THE PT'S SKIN FLAP WOULD "WEEP," BREAKDOWN, BE TREATED MEDICALLY, RESOLVE THEN BEGIN TO "WEEP" AGAIN AFTER APPROX 3 YRS OF IMPLANT USE. PER THE HEALTHCARE PROVIDER, STAPH WAS CULTURED. A REVISION SURGERY WAS DONE (NO DATE AVAILABLE). ON 9/18/96, A SECOND REVISION SURGERY WAS DONE AND THE IMPLANT WAS EXPLANTED. THE SURGEON REPORTEDLY PLANS TO REIMPLANT THE OPPOSITE EAR AT A LATER TIME.
THE DEVICE WAS REMOVED DUE TO A "TUBING FRACTURE AT THE RESERVOIR." AS THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER S-PIECE INFLATABLE PENILE PROSTHESIS.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENIL PROSTHESIS WAS REVISED ON 9/17/96 DUE TO A "TUBING FRACTURE (AT) RESERVOIR." NO IMPLANT INFO WAS PROVIDED. REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
DIALYSIS PT EXPERIENCED ANAPHYLACTOID REACTION AND APNEA FOLLOWING TRANSFUSION THROUGH THE DEVICE. THE PT WAS SUCCESSFULLY RESUSCITATED.
DEVICE EVAL/ANALYSIS: THE SYMPTOM OF HYPOTENSION DURING TRANSFUSION USING THE DEVICE APPEARS LIMITED TO A SMALL COHORT OF CONDITIONS, ALL OF WHICH CAUSE VASCULAR INSTABILITY IN THE PT PRIOR TO BEING TRANSFUSED. SUCH CONDITIONS, KNOWN TO GIVE RISE TO VASCULAR INSTABILITY, MAY BE ANY ONE OR SEVERAL OF THE FOLLOWING CIRCUMSTANCES: HEMODIALYSIS, CARDIAC SURGERY, TRANSFUSION THROUGH CENTRAL LINES, AND USE OF MEDICATIONS THAT RESULT IN VASCULAR INSTABILITY, ESPECIALLY ANGIOTENSIN CONVERTING ENZYME INHIBITORS, AND RAPID TRANSFUSION FLOW RATES. IN THIS SPECIFIC CASE, THE CONDITIONS WERE HEMODIALYSIS AND MEDICATION WHICH GIVES RISE TO VASCULAR INSTABILITY (ANGIOTENSIN CONVERTING ENZYME INHIBITOR). THESE CONDITIONS PER SE DO NOT RESULT IN PRECIPITOUS HYPOTENSIVE REACTION. IT APPEARS THAT SOME VARIABLE IN THE BLOOD COMPONENT TRANSFUSED AS WELL AS AN UNIDENTIFIED IDIOPATHIC FACTOR IN THE PT, MUST ALSO BE PRESENT. IT IS UNCLEAR AS TO WHETHER WHEN THE PRECEDING CONDITIONS AND/OR PRACTICES EXIST IN THE PROPER CONFIGURATIONS, WHETHER THE DEVICE ALSO PLAYS A CONTRIBUTING ROLE IN THE REACTION OBSERVED. THE DEVICE HAS BEEN USED FOR MULTIPLE THOUSANDS OF TRANSFUSIONS (IN THE ABSENCS/AND PRESENCE OF THE ABOVE CONDITIONS) WITHOUT INCIDENCE OF HYPOTENSION REACTIONS. AS NEITHER THE LOT NUMBER NOR THE INVOLVED DEVICE WERE RETURNED, REVIEW OF THE DEVICE'S MFG AND FIELD HISTORY WERE NOT POSSBILE. THERE HAS BEEN NO CORRELATION BETWEEN MFG LOTS AND THESE REACTIONS. THE REACTIONS APPEAR LIMITED TO A SMALL NUMBER OF HLTH CARE FACILITIES. ALTHOUGH THESE REACTION COULD BE CONSISTENT WITH THE PRESENCE OF A SHORT-LIVED BIOLOGICAL MODIFIER, NO EVIDENCE OF SUCH A MODIFIER WAS CONFIRMED IN THESE INSTANCES. THE SPECIFIC CAUSE OF THIS LOW FREQUENCY HYPOTENSIVE REACTION REMAINS UNIDENTIFIED. THE SYMPTOMS, OTHER THAN HYPOTENSION, LED THE RPTR TO CLASSIFY THIS REACRION AS AN ANAPHYLACTOID REACTION. IN SUCH REACTIONS, THE BASIS MAY BE AN IDIOPATHIC REACTION TO A PLASTIC PROTEIN/ANTIGEN IN THE PLASMA OF THE PACKED RED CELLS.
SMALL BALLOON WOULD NOT INFLATE WHILE PRETESTING PRODUCT.
REPORTED INCIDENT OCCURRED DURING PRE-TEST, THERE WAS NO PT INVOLVEMENT. EVALUATION OF RETURNED DEVICE FOUND THE INTERNAL CAROTID BALLOON WOULD NOT INFLATE. THERE WAS A 1.5 MM TEAR ALONG THE DISTAL BOND OF THE BALLOON. CO IS UNABLE TO ASCERTAIN THE EXACT CAUSE FOR THE TEAR. THIS IS THE FIRST REPORTED INCIDENT ON THIS LOT OF PRODUCT.
A CATHETER BROKE DURING A PROCEDURE. THE TIP OF THE CATHETER HAD BEEN GLUED IN PLACE AND THE TIP LEFT IN THE PT. SEVERAL ATTEMPTS TO GET MORE INFO HAVE BEEN UNSUCCESSFUL. THE DEVICE IS NOT AVAILABLE FOR RETURN.
BALLOON WOULD NOT INFLATE, WHILE PRETESTING PRODUCT.
AT 21 MONTHS POSTOP, PT MISSTEPPED AND FELL. PT DID NOT EXPERIENCE ANY DISCOMFORT. SURGEON X-RAYED THE AFFECTED JOINT AND THE X-RAY SHOWED THE TIBIAL INSERT ATTACHMENT SCREW WAS LOACTED POSTERIOR TO THE PROSTHESES. SURGEON HAS SCHEDULED REVISION SURGERY FOR 11/14/96 TO PRECLUDE ANY POTENTIAL ADVERSE EFFECTS.
ARTICULATING SURFACE COMPONENT IS DELAMINATED.
THE DEVICE WAS REMOVED DUE TO AN "EXTRUDED PENILE PROSTHESIS. RESERVOIR." THE RESERVOIR AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
PROSTHESIS FRACTURED REQUIRING REVISION SURGERY.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. IMPLANTS PLACED POSTERIOR MAXILLA TYPE IV BONE. PT IS CONTROLLED DIABETIC. 2 WEEKS AFTER PLACEMENT, PT DEVELOPED WHAT PHYSICIAN THOUGHT WAS A HEART ATTACK AND PT WAS PLACED ON ANTICOAGULANTS. THE PT PRESENTED WITH MOBILE IMPLANTS AT WHICH TIME THEY WERE REMOVED. THE CLINICIAN ATTRIBUTES IMPLANT FAILURE TO THE MEDICATION.
HOSPITAL REPORTS BROKEN HAPTIC PREVENTED LENS FROM CENTERING THEREFORE SUREON HAD TO WIDEN LENS TO REMOVE.
NO ADD'L INFO HAS BEEN RECEIVED DESPITE REQUEST. THE LENS HAS NOT BEEN RETURNED TO THE MFR AS OF 10/14/9. THE REPORTING FACILITY STATED THAT THE LENS WAS CUT IN HALF DURING REMOVAL. IT IS POSSIBLE THE LENS WILL NOT BE RETURNED. THIS REPORT WAS MAILED IN TO FDA ON: 10/16/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
DISTRIBUTOR WAS INFORMED ON AN EXPLANT REPORT THAT THE MFR'S SENSE PACE LEAD ADAPTER WAS BROKEN AND EXPLANTED ON 10/4/93.
THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OF CULPABILITY FOR ANY AND/OR ASPECTS OF THIS EVENT, AND MAY BE BASED UPON INCOMPLETE AND/OR UNSUBSTANTIATED INFO.
VITAMIN SOLUTION SET FOR INFUSION ON SIDE "B" AT RATE OF 20 ML/HR, 171 ML TO BE INFUSED. WHEN CLOSED AND LOCKED, THE DOOR BROKE AT THE CAM LOCK ROTATION POINT, RELEASING CONTROLLING PRESSURE ON THE PUMPING MECHANISM. THE SOLUTION WAS RAPIDLY INFUSED ABOVE THE SELECTED RATE.
DOOR BROKE INTO TWO PIECES. THE PUMP WAS RETURNED TO THE MFR FOR EVAL. VISUAL EXAM OF THE INSTRUMENT CONFIRMED THAT THE CHANNEL B DOOR WAS BROKEN IN TWO PIECES. MFR DID DUPLICATE THE REPORTED INCIDENT. THE PUMP RECEIVED ROUTINE SERVICING. BOTH CHANNEL A AND B DOORS WERE REPLACED AND OTHER ROUTINE REPAIRS WERE PERFORMED. THE PUMP WAS QC TESTED PRIOR TO BEING RETURNED TO THE HOSP FOR USE.
PIECE OF TIP BROKE UPON REMOVAL OF CATHETER FROM PT.
LOT HISTORY RECORD WAS REVIEWED FOR ABNORMALITIES WHICH MAY HAVE CONTRIBUTED TO COMPLAINT. NOTHING KNOWN TO HAVE CONTRIBUTED TO COMPLAINT WAS OBSERVED. LOT WAS MFG, PACKAGED TO SPEC AND PASSED ALL INSPECTIONS PRIOR TO RELEASE. MFG PROCEDURE REQUIRES IN PROGRESS TESTING SAMPLE OF CATHETERS WELDED. FOR THIS LOT 6 SAMPLES WERE TESTED AND ALL READINGS EXCEEDED PROCESS MINIMUM SPEC OF 4 LBS. SAMPLES FROM LOT ALSO TESTED FOR ELONGATION & ALL READINGS EXCEEDED IN PROCESS SPEC OF 4". A 13 PIECES RANDOM SAMPLE OF RAW MATERIAL TUBING LOTS WAS PULL TESTED AT INCOMING. ALL READINGS WERE ABOVE SPEC. ACTUAL COMPLAINT SAMPLE WAS RETURNED FOR EVAL AND FOLLOWING OBSERVATIONS WERE MADE. TIP SECTION OF CATHETER WAS DISCONNECTED FROM CATHETER'S SHAFT AT WELD LOCATION. SLIGHT DISCOLORATION WAS OBSERVED, ALONG WITH MINIMAL ELONGATION OF TIP STOCK MATERIAL. BLACK TIP MATERIAL WAS OBSERVED INSIDE SHAFT STOCK MATERIAL. BLACK SOFT TIP MATERIAL SHOWED SIGNS OF FLOWING AROUND BRAIDED SHAFT STOCK. ALTHOUGH NO SAMPLES FROM COMPLAINT LOT WERE AVAILABLE, TWO STOCK SAMPLES WERE PULLED FROM WAREHOUSE FOR DESTRUCTIVE TESTING IN ATTEMPT TO DUPLICATE COMPLAINT. A GUIDE WIRE WAS INSERTED FULL LENGTH THROUGH THE CATHETER AND THE TIP MATERIAL WAS HELD WITH THE THUMB AND FOREFINGER OF ONE HAND WHILE THE THUMB AND FOREFINGER OF THE OTHER HAND HELD THE CATHETER SHAFT JUST PROXIMAL TO THE WELD. THE CATHETER WAS PULLED TO DUPLICATE THE CONDITION OF COMPRESSION UPON REMOVAL OF CATHETER. THE SAMPLE EXHIBITED THE SAME APPEARANCE WITH SLIGHT DISCOLORATION AND MINIMAL ELONGATION AS THE COMPLAINT SAMPLE. THE SECOND CATHETER WAS TRACKED OVER A GUIDEWIRE AND THEN PLACED IN THE INSTRON FOR A PULL TEST ON THE WELD. THE SYSTEM FAILED WHEN THE SAFETY WIRE ON THE GUIDE WIRE BROKE AT OVER 7 LBS. THE LOT HISTORY RECORD AND THE INCOMING INSPECTION RECORDS FOR THIS LOT WERE REVIEWED FOR ANY ABNORMALITIES WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING KNOWN TO HAVE CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. THE LOT WAS MANUFACTURED TO SPECS AND PASSED ALL INSPECTIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT SAMPLE SHOWED THE TIP OF THE CATHETER WAS OBVIOUSLY SEPARATED FROM THE CATHETER'S SHAFT. SLIGHT DISCOLORATION WAS OBSERVED, ALONG WITH MINIMAL ELONGATION OF THE TIP STOCK MATERIAL. THE BLACK TIP MATERIAL WAS OBSERVED INSIDE THE SHAFT STOCK MATERIAL AND THE BLACK SOFT TIP MATERIAL SHOWED SIGNS OF FLOWING AROUND THE BRAIDED SHAFT STOCK. THE SAMPLE VISUALLY APPEARED TO HAVE A DESIRABLE WELD. AT THIS TIME THE MOST LIKELY CAUSE OF THE COMPLAINT IS IMPROPER USER HANDLING. IT APPEARS THAT THE CATHETER WAS REMOVED FROM THE PT OVER A GUIDEWIRE AND EXCESSIVE COMPRESSION APPLIED TO THE PUNCTURE SIGHT. THE AMOUNT OF COMPRESSION WAS FINE FOR THE BRAIDED SHAFT BUT WHEN THE TIP MATERIAL SAW THIS SAME COMPRESSION IT WAS ENOUGH TO BREAK THE TIP IN TWO. THIS DEFECT HAS BEEN NOTED FOR TRENDING. FREQUENCY HAS NOT INCREASED NOR IS THE SEVERITY OF THIS EVENT GREATER THAN USUAL.
TWO SUTURELESS LEADS WERE REMOVED DUE TO "LEAD FRACTURE." DURING A REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE LEADS WERE CAPPED AND REPLACED WITH A BIPOLAR LEAD.
THE DEVICE WAS REMOVED DUE TO AN "INFECTION", AS WELL AS "TUBING EROSION THROUGH THE SKIN." THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED.
THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 4/5/95 AND REMOVED ON 8/5/96 DUE TO AN "INFECTION." IN THE RECEIVED INFO THE MD STATED THAT HE REMOVED AN "INFECTED" PROSTHESIS BUT THAT IN ADDITION TO THE INFECTION THE "TUBING HAD ERODED THROUGH THE SKIN." THE PT STATED THAT THE DEVICE "NEVER WORKED," AND THAT "HE COULD NOT DEFLATE THE CYLINDER(S), AT LEAST ONE WOULD REMAIN INFLATED," HOWEVER, THE MD STATED THAT THE PT WAS "NEVER HAPPY WITH THE INFLATABLE PROSTHESIS" AND THAT THIS WAS MORE THE ISSUE THAN THE DEVICE "NOT WORKING." REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEIVCE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENTS. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL REEVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT ANY INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE.
THE MFR'S SENSE PACE LEAD ADAPTER WAS BROKEN AND CAUSING NOISE WHICH CHARGED THE ICD REPEATEDLY AND RESULTED IN LOW BATTERY VOLTAGE. THE ADAPTER WAS EXPLANTED ON 12/7/93. THERE IS NO INDICATION THAT THE ICD DID NOT FUNCTION PROPERLY.
ACCORDING TO A MEDICAL HISTORY REPORT, OBTAINED BY THE REPORTER, THE PT'S HEART VALVE WAS REPLACED BECAUSE OF A FRACTURE. NO DETAILS OF THE ACTUAL EVENTS ARE AVAILABLE, INCLUDING THE VALVE MODE AND SERIAL NUMBER.
SECTION F WAS COMPLETED BY THE MFR. NO MEDWATCH REPORT WS RECEIVED FROM THE USER FACILITY.
MFR RECEIVED A REPORT OF A THROTTLE STICKING ON A POWER SCOOTER. THE USER TURNED SHARPLY TO AVOID HITTING SOME PEDESTRIANS. AS A RESULT, THE SCOOTER TIPPED AND THE USER FELL. REPORTED INJURIES WERE NOT SERIOUS.
DURING AN UNSPECIFIED PROCEDURE. THE SUTURE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED TAHT NO PT INJURY OCCURRED.
11/21/96-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D7, D8 AND D9. CORRECTED DATA ENTERED IN B4 AND F8.
DR REPORTS THE PT EXPERIENCED RECURRING INTRAVITREAL HEMORRHAGES POST-OPERATIVE LENS IMPLANTATION OD WHICH SUBSIDED AFTER 5-6 MONTHS. A DENSE WHITE ORGANIZED MEMBRANE FORMED PRE-RETINAL WHICH WOULD NOT CLEAR THEREFORE THE LENS WAS EXPLANTED. THE PT IS CURRENTLY APHAKIC. A B-SCAN DEMONSTRATED RETINAL DETACHMENT. A VITRECTOMY WILL BE PERFORMED AT A LATER DATE. THERE WAS NO SIGNIFICANT BLEEDING UPON REMOVAL OF THE IOL.
THE RETURNED EXPLANTED LENS WAS EVALUATED AND CONFIRMED TO MEET ALL RELEASE SPECS. THIS REPORT WAS MAILED IN TO FDA ON: 2/18/97.
WHEN TPN BAG WAS HUNG, THE MIDDLE OR PORT CAME OFF WHILE HANGING, SPILLING THE CONTENTS ALL OVER.
EMT'S ATTENDED TO A PT IN FULL CARDIAC ARREST. USING A SEMI AUTOMATIC EXTERNAL DEFIBRILLATOR AND DISPOSABLE DEFIBRILLATION ELECTRODES, DEFIBRILLATION THERAPY WAS ADMINISTERED TWICE AT THE 200 JOULE SETTING. THE PT WAS CONVERTED TO A PROFUSING RHYTHM. PARAMEDICS ARRIVED ON SCENE AND PER LOCAL PROTOCOL TOOK OVER AS PRIMARY CARE PROVIDERS. ALLEGEDLY DURING THE TRANSFER FROM ONE DEFIBRILLATOR TO THE OTHER, AN ELECTRODE POST WAS BROKEN OFF. THE PT WAS TRANSFERRED TO THE HOSP. THE REPORTER INDICATED PT CARE WAS NOT AFFECTED BY THE BROKEN POST. THE OPINION WAS BASED UPON THE IMMEDIATE AVAILABILITY OF A SECOND SET OF ELECTRODES.
CO INSPECTED A ELECTRODE RETURNED FROM THE CUSTOMER AND OBSERVED THE POST TO BE DISLODGED FROM THE ELECTRODE. EVIDENCE OF EXCESSIVE MECHANICAL FORCE WAS OBSERVED ON THE SURFACE OF THE POST AND THE ELECTRODE POST CRIMP. AFTER FURTHER INQUIRY, THE CUSTOMER DIVULGED THEY WERE CURRENTLY USING A HARD SURFACE WHEN SEATING THE ELECTRODES ONTO THE ELECTRODE CABLE. PROPER OPERATING PROCEDURES WERE REVIEWED AND ADD'L TRAINING MATERIAL WAS SENT TO THE FACILITY.
DURING BREAST BIOPSY PROCEDURE, A PORTION OF A NEEDLE WAS LEFT IN THE TISSUE. TWO YRS LATER PT INITIATED LITIGATION AGAINST HOSPITAL.
THE STAPLER WOULD NOT RELEASE THE STAPLES REQUIRING HAND SUTURING. THERE WAS NO PT HARM.
IN A RECEIVED OPERATIVE REPORT THE PHYSICIAN INDICATED THE FOLLOWING: "THE [DEVICE'S] DEFECT WAS A SPLIT IN THE TUBING OF THE RESERVOIR TUBING WHICH EXITED THE PUMP PLATFORM." AFTER THE DR. REPLACED THE PUMP, "THE PROSTHESIS CYCLED SATISFACTORILY." THE PUMP WAS RECEIVED AND EVALUATED BY THE MFR. DURING FUNCTIONAL TESTING, A LEAKAGE SITE WAS OBSERVED AT THE PUMP'S INLET TUBING, NEAR THE STRAIN RELIEF. A MICROSCOPIC EXAMINATION OF THE LEAKAGE SITE WAS PERFORMED. THE CROSS SECTIONAL SURFACE AREA OF THE LEAKAGE SITE WAS ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. THIS TUBING WAS RECEIVED BENT ANTERIORLY (AWAY FROM THE LEAKAGE SITE), INDICATING THAT THE TUBING WAS POSITIONED IN A BENT MANNER FOR A LONG PERIOD OF TIME. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCE'S EVALUATION, QA CONCLUDES THE FOLLOWING: A LEAK EXISTS WITH THIS DEVICE, AND THE TUBING TEAR THAT CAUSED THIS LEAK WAS CAUSED BY STRESS(ES) CONTRIBUTED BY THE POSITION OF THE DEVICE WHILE IN-VIVO AND FROM STRESS(ES) ASSOCIATED WITH DEVICE USAGE OVER TIME. THE PATIENT HISTORY ALSO INDICATED THE PATIENT HAS HAD TWO PREVIOUS PENILE IMPLANTS AND THE REPORT OF A HEMATOMA TWO WEEKS POST OP IN 1991.
PER THE INFORMATION PROVIDED TO CO THROUGH MEANS OF THE PHYSICIAN/SURGEONS OPERATIVE REPORT, IT WAS STATED.."OPERATIVE PROCEDURE: REVISION OF PENILE PROSTHESIS WITH REPLACEMENT OF PUMP". DURING THE PROCEDURE IT WAS STATED,..."THE DEFECT WAS A SPLIT IN THE TUBING OF THE RESERVOIR TUBING WHICH EXITED THE PUMP PLATFORM. THE SYSTEM WAS PURGED WITH ANTIBIOTICS, TOTALLY EVACUATED THE FORMER FLUID. THE RESERVOIR WAS FILLED WITH 120 CC, SPLITTING ITS CAPSULE, THEN LEAVING 100 CC IN THE SYSTEM. THREE TRUE LOCK CONNECTORS WERE USED TO CONNECT THE PUMP THE CYLINDERS AND THE RESERVOIR. THE PROSTHESIS CYCLED SATISFACTORILY".
THE PRODUCT WAS USED DURING AN UNSPECIFIED THYROID PROCEDURE. THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP AS REPORTED THAT NO PT INJURY OCCURRED.
10/21/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THIS EVENT WAS REPORTED AS: THROMBOSIS. NO FURTHER INFO PROVIDED. EXPIRATION DATE: 6/1/2000.
STAPLER DID NOT WORK PROPERLY DURING SURGERY. NO PT HARM.
THE INSTRUMENT WAS NEVER CLINICALLY APPLIED. REPORTEDLY, THE INSTRUMENT EJECTED CLIPS PREMATURELY.
THE STAPLER FIRED AND RELEASED STAPLES BUT IT DID NOT WORK. NO PT HARM.
CATHETER WAS PULLED APART BY DISORIENTED 90 YR OLD PT. CATH WAS INDWELLING LESS THAN 24 HRS. PT VERY RESTLESS & PULLING ON CATH FOR 12 HRS & FINALLY SETTLED DOWN. PT WAS TRANSFERRED TO ANOTHER HOSP. TO HAVE INDWELLING CATH REMOVED. THIS WAS PERFORMED TRANSURETHRALLY W/FLUOROSCOPE. THE CATH WAS NOT REPLACED AND PT WAS ABLE TO VOID ON HIS OWN. NO OTHER COMPL.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT AS DEFINED BY THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT RECURS. THIS CATHETER IS A ONE-PIECE DESIGN W/NO BONDED AREAS. THE CATH SHAFT IS FORMED BY MULTIPLE LAYERS OF LATEX WHICH CREATES A STRONG SHAFT THAT NORMALLY WITHSTANDS A MINIMUM PULL FORCE OF 60 LBS. CONTINUOUS STRETCHING, PULLING CAN RESULT IN BREAKAGE AS THE LAYERS OF LATEX SEPARATE AND IS USUALLY ASSISTED BY SOME SHARP OBJECT.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS SCISSORED. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE PRODUCT WAS USED DURING AN UNSPECIFIED THYROID PROCEDURE. THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THIS EVENT WAS REPORTED AS: UNK. NO FURTHER INFO PROVIDED.
IV PUMP INFUSED 1000CC OF NS WITH 20 MEQ OF KCL OVER 3.5 HRS INSTEAD OF 75CC THAT THE PUMP WAS SET AT.
DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE TIP OF THE INSTRUMENT BROKE OFF OUTSIDE OF THE PT'S CAVITY. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE,
PER THE INFO PROVIDED TO CO'S OFFICE THROUGH MEANS OF THE PHYSICAN/SURGEON'S OPERATIVE REPORT WHICH ACCOMPANIED THE DEVICE COMPONENT, IT WAS STATED "PROSTATE DIAGNOSIS: MALFUNCTION OF THE PENILE PROSTHESIS. OPERATION: REVISION OF PENILE PROSTHESIS. REPLACEMENT OF PUMP DUE TO A TUBING FRACTURE, LEFT CYLINDER TUBING AT LEVEL OF STRAIN RELIEF, SECONDARY TO A FLUID LOSS." DURING THE COURSE OF THE EVENT THE SURGEON STATED "THE TUBING TO ONE OF THE CYLINDERS HAD COMPLETELY SEVERED AT THE PUMP PLATFORM. THE TUBING WAS RESECURED. THE PUMP WAS REMOVED. THE NEW PUMP WAS CONNECTED WITH 3 CONNECTORS. THE PROSTHESIS CYCLED SATISFACTORILY.
ACCORDING TO AVAILABLE INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 10/8/92. ON 9/18/96 DEVICE WAS EXPLANTED, REPORTEDLY BECAUSE OF A "FLUID LOSS" DUE TO A "TUBING FRACTURE - LEFT CYLINDER." IN RECEIVED OPERATIVE REPORT, PHYSICIAN INDICATED FOLLOWING: "TUBING TO ONE OF CYLINDERS COMPLETELY SEVERED AT PUMP PLATFORM", AND AFTER DR REPLACED PUMP "...PROSTHESIS CYCLED SATISFACTORILY." PUMP AND A DETACHED SECTION OF PUMP TUING WERE RECEIVED AND EVALUATED BY MFR. A LEAKAGE SITE BETWEEN SECTION OF TUBING AND PUMP'S OUTLET #1 WAS CONFIRMED. MICROSCOPIC EXAMINATION OF TUBING ENDS OF PUMP'S OUTLET #1 AND CORRESPONDING TUBING END OF ECTION OF TUBING SHOWED CROSS SECTIONAL SURFACES THAT WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. BASED ON RECEIVED INFO AND QUALITY ASSURANCE'S EVAL, QA CONCLUDES FOLLOWING: TUBING TORE BETWEEN PUMP OUTLET #1 AND SECTION OF TUBING, TEAR SEPARATED TWO COMPONENTS, AND THIS TEAR CAUSED REPORTED FLUID LOSS. TUBING TEAR WAS CAUSED BY STRESSES TO DEVICE WHILE IN-VIVO.
ANGIOPLASTY BALLOON RUPTURED DURING PROCEDURE WITH NO ADVERSE EFFECT TO THE PT.
DURING A LAPAROSCOPIC HERNIA PRODCEDURE, THE INSTRUMENT MISFIRED. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THIS EVENT WAS REPORTED AS DEVICE EXPLANTED, REASON UNK. NO FURTHER INFO PROVIDED.
DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PRODCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS REMOVED AS "THE PUMP DID NOT EMPTY WELL." TO CO, THE PUMP AND CONNECTOR COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
THOUGH THE EXPLANT OPERATIVE REPORT "DIAGNOSIS" AND THE DEVICE TRACKING REPORT NOTED MALFUNCTION OF THE DEVICE, THE EXPLANT OPERATIVE REPORT TEXT NOTED THAT THE DEVICE CONTAINED 90 CC'S OF FLUID IN A 100 CC RESERVOIR. THE PUMP WAS RECEIVED AND EVALUATED BY THE MFR. THE PUMP PASSED ALL FUNCTIONED ALL FUNCTIONAL TEST. MICROSCOPIC EXAMINATION OF THE PUMP'S DISTAL TUBING ENDS SHOWED CROSS SECTIONAL SURFACES THAT WERE ROUGH AND IRREGULAR, INDICATING CONTACT WITH SHARP INSTRUMENTATION, SUCH AS A SCALPEL OR SCISSORS. BASED ON THE DURATION THIS DEVICE WAS IMPLANTED, QA CONCLUDES THAT THE INSTRUMENT CONTACT OCCURRED DURING OR SUBSEQUENT TO EXPLANT SURGERY, AND THUS IS NOT RELATED TOT HE RECEIVED COMPLAINT. BASED ON THE FUNCTIONAL TEST RESULTS AND MICROSCOPIC EXAMINATION, QA IS UNABLE TO CONFIRM THE REPORTED "PUMP DID NOT EMPTY WELL." AND IS PRECLUDED FROM DETERMINING THE CAUSE FOR THIS OCCURRENCE.
THE COMPLAINT WAS REC'D WITH THE FOLLOWING DESCRIPTION: PULSE SPRAY CATHETER WAS ADVANCED THROUGH THE SKIN INTO A DIALYSIS GRAFT WITHOUT A SHEATH. THE CATHETER KINKED AT AN UNK POSITION DURING INSERTION. THE CATHETER SEPARATED AT THE KINK. FRAGMENTED CATHETER WAS RETRIEVED WITHOUT COMPLICATION. DOCTOR BELIEVES THAT THE CATHETER MAY HAVE BEEN DAMAGED DURING INSERTION DUE TO A SCARRED GRAFT.
THE EXACT CAUSE OF THIS FAILURE CAN NOT BE DETERMINED, BUT IT IS KNOWN THAT THE PRODUCT WAS USED AGAINST LABELING IN THAT AN INTRODUCER SHEATH WAS NOT USED WHEN ACCESS THROUGH A GRAFT WAS PERFORMED. THE INSTRUCTION FOR USE IC 350 WHICH IS PACKAGED WITH THIS PRODUCT STATES: "THE USE OF AN INTRODUCER SHEATH IS RECOMMENDED IF PUNCTURE THROUGH A SYNTHETIC GRAFT IS NECESSARY. FAILURE TO USE AN INTRODUCER SHEATH MAY RESULT IN DAMAGE TO THE CATHETER".  NUMBER OF ADD'L PAGES 1.
THIS EVENT WAS REPORTED AS ENDOCARDITIS AND VEGETATION. THE PT IS REPORTED AS CLINICALLY FINE. PT WAS TREATED WITH ANTIBIOTICS. NO FURTHER INFO PROVIDED.
DURING AN UNSPECIFIED PROCEDURE, THE SUTURE BROKE.
11/5/96 - SUPPLEMENTAL REPORT #1 SENT TO FDA. ADDITIONAL DATA ENTERED IN D7, D8, D9, E1 (ADDRESS ANDN PHONE#) ANDN F5. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN F6.
THE DISPOSABLE LOADING UNIT WAS USED WITH A 10MM REUSABLE STAINLESS STEEL INSTRUMENT DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS DID NOT ADVANCE OR FORM PROPERLY. THE SURGEON APPLIED A DISPOSABLE INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THIS EVENT WAS REPORTED AS: "DYSFUNCTION." NO FURTHER INFO PROVIDED.
THIS EVENT WAS REPORTED AS: " DYSFUNCTION" AND PARAVALVULAR LEAK. NO FURTHER INFO PROVIDED.
THIS EVENT WAS REPORTED AS: "FAILURE", STENOSIS AND INSUFFICIENCY. NO FURTHER INFO PROVIDED.
THIS EVENT WAS REPORTED AS INFECTED GRAFT. NO FURTHER INFO PROVIDED. EXPIRATION DATE: 8/1/2000.
A PT WAS TREATED ON 10/15/96 TO THE LATERAL CHIN LINES AND VERTICAL LINES ABOVE THE UPPER LIP AT 3:30 PM. THE PT WENT HOME THEN HAD DINNER AT A RESTAURANT AT APPROX 5:30 PM. APPROX ONE HOUR LATER, SHE DEVELOPED SWELLING AND SLIGHT ERYTHEMA AT THE LEFT UPPER LIP TREATMENT SITE WHICH EXTENDED TO THE LEFT UPPER VERMILION AND INNER MUCOSA. LATER IN THE EVENING ON 10/15/96, THE PT WAS SEEN BY THE INJECTING PHYSICIAN'S OFFICE ASSOCIATE WITH CONTINUING SYMPTOMS. THE PHYSICIAN WAS UNSURE OF THE DIAGNOSIS; INTRAMUSCULAR CELESTONE AND AN ORAL ANTHISTAMINE WERE PRESCRIBED. THE PT WAS SEEN ON 10/16/96, BY THE INJECTING PHYSICIAN DIAGNOSED ANGIODEMA WITH ETIOLOGY POSSIBLY RELATED TO SOMETHING THE PT HAD FOR DINNER, TO VASOTEC, AN ACE-INHIBITOR THE PT HAD BEEN TAKING CONCOMITANTLY FOR YEARS, OR TO THE COLLAGEN TREATMENT.
THIS EVENT WAS REPORTED AS: "DEGENERTION." NO FURTHER INFO PROVIDED.
CODE 86: EVALUATION OF EVENT BASED ON HISTORY OF DEVICE AND CONTENT OF THIS EVENT DESCRIPTION. THIS INFO WAS REPORTED TO A CO CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. PRODUCT WAS USED IN THE RCFA FOLLOWING A PTCA PROCEDURE WITHOUT APPARENT COMPLICATIONS. ONE TO TWO HOURS POST PROCEDURE, RIGHT PULSES WERE LOST. ULTRASOUND SHOWED DECREASED CIRCULATION. THE PHYSICIAN THOUGHT THE COLLAGEN WAS DEPRESSING THE ARTERY. THE COLLAGEN WAS SURGICALLY REMOVED FROM THE TISSUE TRACT AND CIRCULATION WAS RESUMED. THERE WERE NO FURTHER COMPLICATIONS. CODE 300: IT IS VERY UNLIKELY THAT THE AMOUNT OF PRESSURE REQUIRED TO DRASTICALLY REDUCE CIRCULATION COULD BE CAUSED BY THE PRESENCE OF THE COLLAGEN. CO ASSUMES THAT THIS WAS AN INTERMITTENT CLAUDICATION UNRELATED TO THE CO PROCEDURE.
NO DRIVE PRESSURE WAS AVAILABLE ON ONE MODULE OF A BACK-UP VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DUAL DRIVE CONSOLE. THERE WAS NO FAILURE OF THE ORIGINAL VAD DRIVE CONSOLE REQUIRING A CHANGE TO THE BACK-UP DRIVE CONSOLE, HOWEVER, THE BATTERIES IN THE ORIGINAL DRIVE CONSOLE WERE NOT FULLY CHARGED AND THE PT WAS TO BE TRANSPORTED ON THE ORIGINAL DRIVE CONSOLE USING AN EXTERNAL BATTERY POWER SUPPLY WITHOUT INCIDENT.
WHEN THE BACK-UP VAD DRIVER WAS NOTED TO HAVE NO DRIVE PRESSURE AVAILABLE ON ONE MODULE, THE HOSP CONTACTED CO AND ARRANGEMENTS WERE MADE FOR CO FIELD SVC PERSONNEL TO EVALUATE THE DEVICE ON-SITE THE NEXT DAY. INSPECTION OF THE DRIVE CONSOLE REVEALED THAT THE COMPRESSION FITTINGS ON THE PNEUMATIC PRESSURE TUBING HAD NOT BEEN PROPERLY TIGHTENED AT THE AIR COMPRESSORS, ALLOWING THE TUBING TO DISCONNECT. THE PRESSURE TUBING WAS RECONNECTED AND THE FITTINGS TIGHTENED, WHEREUPON THE DRIVE CONSOLE RESUMED PROPER OPERATION. A CO FAILURE INVESTIGATION WAS INITIATED AND DETERMINED THAT THE REPORTED FAILURE WAS DUE TO AN ASSEMBLY ERROR DURING MFR OF THE COMPRESSOR TRAY SUB-ASSEMBLY OF THE VAD DRIVE CONSOLE. THE FITTINGS CONNECTING THE PRESSURE TUBING FROM THE COMPRESSORS TO THE DRIVE MODULES HAD NEVER BEEN TIGHTENED, ALLOWING THE TUBING TO DISCONNECT FROM THE COMPRESSOR WHEN UNDER PRESSURE. A REVIEW OF THE DEVICE HISTORY RECORDS AND FINISHED ASSEMBLIES REVEALED THAT THE ASSEMBLY ERROR WAS ASSOCIATED WITH TWO NEW OPERATORS. PREVIOUSLY, THIS ASSEMBLY HAD BEEN PERFORMED BY ONLY TWO OTHER PEOPLE OVER THE LAST TWELVE YEARS WITH NO REPORTED FAILURES OF THIS TYPE. NINETEEN VAD DRIVE CONSOLES WERE IDENTIFIED AS HAVING COMPRESSOR TRAYS ASSEMBLED BY THE TWO NEW OPERATORS. AN ADD'L TRAINING SESSION, CONDUCTED BY THE MFR OF THE TUBING FITTINGS, IS SCHEDULED FOR 10/30/96. QUALITY ASSURANCE PERSONNEL HAVE BEEN INSTRUCTED TO CHECK THE SECURITY OF PRESSURE TUBING IN ITS FITTINGS. THE INCIDENCE OF FAILURES OF THIS TYPE WILL BE MONITORED TO DETERMINE IF ANY FURTHER CORRECTIVE ACTION IS NECESSARY.
A PT WAS TREATED ON 6/17/96 TO THE NASOLABIAL FOLDS, GLABELLA AND LINES INFERIOR AND LATERAL TO THE EYES. ON 8/13/96, THE PT DEVELPED SLIGHT SWELLING AT THE COLLAGEN INJECTION SITE, JUST BELOW THE RIGHT LOWER EYELID. ON 8/14/96, THE PT WAS SEEN BY THE INJECTING PHYSICIAN'S ASSOCIATE WHO DIAGNOSED AN INSECT BITE AND PRESCRIBED TOPICAL CORTISONE CREAM AND AN ORAL ANTHISTAMINE. ON 10/17/96, THE PT WAS SEEN WITH PALPABLE BEADS OF COLLAGEN AT THE RIGHT NASOLABIAL FOLD AND UNDER THE RIGHT EYE INJECTION SITE. THE SITE UNDER THE RIGHT EYE APPEARED SLIGHTLY SWOLLEN. THE PT REPORTED CONTINUING, INTERMITTENT SWELLING AT THE NASOLABIAL FOLDS AND PERIORBITAL TREATMENT SITES. THE INJECTING PHYSICIAN DIAGNOSED A POSSIBLE HYPERSENSITIVITY TO COLLAGEN;' NO ADD'L MEDICAL OR SURGICAL INTERVENTION WAS PRESCRIBED OR PLANNED.
THE PHYSICIAN REPORTED THAT THE SYMPTOMS RESOLVED ON APPROX 10/21/1996.
RN WAS HANGING BLOOD AND ATTEMPTED TO PRIME BLOOD THROUGH LEUKOCYTE FILTER. WHILE FIRMLY SQUEEZING BLOOD BAG TO MILK THE BOOOD THROUGH THE FILTER THE TUBING BUSTED ABOVE THE DRIP CHAMBER. THIS CAUSED BLOOD TO SPLASH ON THE EMPLOYEE. THE BLOOD WAS ALSO CONTAMINATED AND HAD TO BE DISPOSED OF AND REPLACED.
THIS EVENT WAS REPORTED AS CALCIFICATION AND STENOSIS. NO FURTHER INO PROVIDED.
CODE 86: EVALUATION OF EVENT BASED ON HISTORY OF DEVICE AND CONTENT OF EVENT DESCRIPTION. THIS INFO WAS REPORTED TO A CO CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. PRODUCT WAS USED IN RCFA FOLLOWING A PTCA PROCEDURE. DURING DEPLOYMENT OF CO COLLAGEN PROCEDURAL COMPLICATIONS WERE ENCOUNTERED AND HEMOSTASIS WAS LOST SEVERAL TIMES WHILE DEPLOYING COLLAGEN. HEMOSTASIS WAS FINALLY ACHIEVED FOLLOWING 15 MINUTES OF OCCLUSIVE PRESSURE. A SMALL HEMATOMA HAD FORMED. SITE WAS STABLE FOR THE NEXT 20 HRS DURING WHICH TIME PT WAS UP TO BEDSIDE COMMODE AND UP IN CHAIR. THE FOLLOWING DAY, PT ON BEDPAN, HEMATOMA BEGAN TO EXPAND. DIRECT PRESSURE AND CLAMP WERE NOT SUCCESSFUL IN CONTROLLING EXPANSION. SURGICAL REPAIR OF PSEUDOANEURYSM WAS DONE. THERE WERE NO FURTHER COMPLICATIONS. HEMATOMAS AND PSEUDOS CAN RESULT IF THE CO COLLAGEN IS NOT REPLACED ACCURATELY OVER ARTERIAL PUNCTURE. HOWEVER, THESE COMPLICATIONS ARE NOT UNUSUAL FOLLOWING CARDIAC CATHETERIZATION PROCEDURES.
A PT WAS DOUBLE SKIN TESTED ON 8/13/96 AND 8/27/96 AND RECEIVED HER FIRST TREATMENT ON 9/19/96 IN THE GLABELLA, NASOLABIAL FOLDS, ORAL COMMISSURES AND VERTICAL LINES OF THE PERIORAL AREAS. ON 9/22/96, THE PT NOTED AND PRESENTED WITH SWELLING, ITCHING AND INTERMITTENT REDNESS AT ALL TREATMENT SITES AND THE SECOND TEST SITE. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY; ATARAX AND MEDROL WERE PRESCRIBED. ON 10/14/96 THE PT PRESENTED WITH PERSISTENT SYMPTOMS; SHE REPORTED FATIGUE WHICH THE PHYSICIAN ATTRIBUTED TO THE ATARAX. THE ATARAX DOSE WAS REDUCED.
THE PHYSICIAN REPORTED THAT THE PT WAS LAST SEEN ON 22 DECEMBER 1998. THE SYMPTOMS WERE ONGOING. THE PHYSICIAN PERFORMED AN INCISION AND DRAINAGE AND PRESCRIBED ANTIBIOTICS.
RN DEVELOPED LATEX HYPERSENSITIVITY AFTER YEARS OF WORKING NICU AND USING LATEX GLOVES. AS A RESULT OF HER ALLERGY SHE IS NOW DISABLED DUE TO NUMEROUS ADVERSE EVENTS INCLUDING "OCCUPATIONAL ASTHMA" AND ANAPHYLAXIS TO AIRBORNE LATEX.
THIS EVENT WAS REPORTED AS AORTIC VALVE INSUFFICIENCY. NO FURTHER INFO PROVIDED.
CODE 86: EVALUATION OF EVENT BASED ON MFG AND QC PROCEDURES, HISTORY OF DEVICE AND CONTENT OF EVENT DESCRIPTION. THIS INFO WAS REPORTED TO A CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. PRODUCT WAS USED IN THE RCFA FOLLOWING A STENT PROCEDURE WITHOUT APPARENT COMPLICATIONS. A SMALL PIECE OF COLLAGEN WAS PROTRUDING FROM THE GROIN SITE. PHYSICIAN CUT IT OFF AND APPLIED A STERILIE DRESSING. ONE WEEK LATER THE PT WAS HOSPTIALIZED WITH CELLULITIS. PT TREATED WITH ANTIBIOTICS AND DISCHARGED AFTER A FEW DAYS WITH NO FURTHER COMPLICATIONS. CODE 300: SINCE THE CULTURES WERE NEGATIVE CO CANNOT CONCLUDE THAT THERE WAS AN INFECTION. NORMAL TISSUE REACTION TO THE PRESENCE OF A FOREIGN BODY (COLLAGEN) COULD CAUSE INFLAMMATION WHICH IS ALSO A SYMPTOM OF CELLULITIS.
X-TUBE ASSEMBLY 16" X 17". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO , ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
MECHANICAL OBSTRUCTION AND DISTENTION SECONDARY TO HYPERINFLATED TUBE BALLOON. BOWEL RESECTION REQUIRED.
RN WITH KNOWN HYPERSENSITIVITY TO LATEX REPORTS THAT HER 5 Y/O SON HAS ASTHMA, NUMEROUS FOOD AND DRUG ALLERGIES, LATEX HYPERSENSITIVITY AND ALLERGIES TO INSECT BITES AS A RESULT OF HER LATEX ALLERGY.
CODE 86: EVALUATION OF EVENT BASED ON MFG AND QC PROCEDURES, HISTORY OF DEVICE AND CONTENT OF EVENT DESCRIPTION. THIS INFO WAS REPORTED TO A CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. PRODUCT WAS USED IN THE RCFA FOLLOWING A STENT PROCEDURE. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PT DEVELOPED A HEMATOMA AND A PSEUDOANEURYSM WHICH WAS TREATED WITH ULTRASOUND GUIDED COMPRESSION. SEVENTEEN DAYS FOLLOWING THE PROCEDURE, PT WAS READMITTED FOR STAPH INFECTION AND TREATED WITH ANTIBIOTICS. CODE: 200: HEMATOMAS AND PSEUDOANEURYSMS CAN OCCUR IF THE COLLAGEN IS NOT PLACED ACCURATELY OVER THE ARTERIAL PUNCTURE. HOWEVER, THESE COMPLICATIONS ARE NOT UNUSUAL FOLLOWING CARDIAC CATHETERIZATION PROCEDURES. THEREFORE, CO CAN NOT ATTRIBUTE THESE EVENTS TO THE USE OF PRODUCT. CODE 300: BASED ON MFG AND QC PROCEDURES, THE PRODUCT WAS PROABABLY CAUSED BY INADVERTENT CONTAMINATION AFTER PT WAS DISCHARGED.
PT AICD WAS NOT WORKING ENTIRELY CORRECTLY, AND BATTERY REPLACEMENT WAS SCHEDULED. ERROR MESSAGE WAS ENCOUNTERED, AND AICD WAS REMOVED AND REPLACED WITH A NEW ONE INSTEAD. PT WAS STABLE AND WENT HOME THAT EVENING.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PROBE COMES IN UNSTERILE SEALED PACKAGE. PACKAGE STATES THAT THE PROBE SHOULD BE STERILIZED WITH ETHYLENE OXIDE. RPTR STERILIZED THE PRODUCT AS DIRECTED, THE STERILIZER INDICATOR INDICATED THAT STERILIZATION WAS ACHIEVED UPON OPENING THE PACKAGE HOWEVER, THE PROBE WAS FOUND TO BE NOT STERILIZED. RPTR CALLED CO AND WAS TOLD THAT SHE SHOULD HAVE TAKEN THE PROBE OUT OF THE PACKAGE AND THEN STERILIZED IT. THE PRODUCT PACKAGE DOES NOT GIVE THIS DIRECTION.
NO SAMPLE RETURNED & NO RESPONSE REGARDING ADD'L INFO INQUIRY DESPITE 3 ATTEMPTS. CATALOG # ASSIGNED BY MODEL INFO.; NOT PROVIDED BY UF. BALLOON WAS GROSSLY OVERINFLATED AND APPARENTLY LED TO REMOVAL OF PART OF THE SMALL INTESTINE. THERE WAS NO ALLEGED FAILURE OF THE DEVICE TO PERFORM ITS INTENDED FUNCTION. LABEL STATES TO INFLATE W/10CC AIR/WATER W/ADD'L 25 CC W/IN 25 MINUTES. THIS BALLOON CONTAINED 570 ML OF WATER W 70G OF MERCURY. PT AND DEVICE COEDS WERE LISTED AS NA.
DURING A CODE: MALE AGE 70'S WAS IN CARDIAC ARREST, UNIT WAS HOOKED, PADS WOULD NOT SEPARATE CORRECTLY. AFTER SEVERAL PAIRS OF PADS WERE USED, THEY FINALLY WERE ABLE TO GET A GOOD PAIR. NO PADS ARE COMING BACK. PT WAS TRANSPORTED TO A HOSP AND PRONOUNCED.
CO RECEIVED THE UNIT ON NOVEMBER 4, 1996. CO INSPECTED THE UNIT AND NOTICED THAT THE POWER SWITCH CABLE WAS NOT SEATED IN THE POWER RECEPTACLE. THERE WAS NO INDICATION OF DAMAGE TO THE RECEPTACLE OR CABLE. WE RE-INSERTED THE CABLE AND TESTED THE POWER SWITCH MECHANISM. THE UNIT TURNED ON AND WORKED ACCORDING TO SPECIFICATIONS. CO COULD NOT DETERMINE WHAT CAUSED THE CABLE TO COME LOOSE FROM THE RECEPTACLE AND COULD NOT DUPLICATE THE OCCURRENCE. ALTHOUGH THE SWITCH MECHANISM OPERATED CORRECTLY AFTER REINSERTING THE CABLE, CO REPLACED THE SWITCH ASSEMBLY AND POWER RECEPTACLE PRIOR TO RETURNING THE UNIT TO THE CUSTOMER. FROM REVIEWING REPAIR HISTORY AND RECORDS, CO SHOWS THIS TO BE AN ISOLATED INCIDENT AND THE LIKELIHOOD OF THIS OCCURRING AGAIN IS RARE. IN ADDITION, CO SENT FIELD ENGINEER TO MEET WITH THE BIOMEDICAL ENGINEER WHO REPORTED THE DEVICE FAILURE. IN THAT MEETING, HE STATED THAT WHEN THE ANESTHETIST FELT THE PT WAS PROPERLY CONNECTED TO THE MONITOR AND TRIED TO TURN THE UNIT ON, THE UNIT FAILED TO TURN ON. OTHER ARRANGEMENTS WERE MADE IN REGARDS TO MONITORING, AND THE PT SUSTAINED NO INJURY DUE TO THIS INCIDENT. AFTER REVIEWING THIS INFO AND THE MEDICAL DEVICE REPORTING POLICY, CO DOES NOT FEEL THAT THIS INCIDENT IS REPORTABLE UNDER THE MDR REQUIREMENTS.
X-TUBE ASSEMBLY 18" X 18". DEALER CLAIMS X-TUBE BROKE AT CTR BOLT.
INNER WRAPPER STUCK TO OUTER WRAPPER, CAUSED SOME SUPPLIES TO BE CONTAMINATED.
X-TUBE ASSEMBLY 20" X 10". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. CLINICIAN REPORTS "BECAUSE OF HA AUGMENTATION WE FEEL THERE WAS A LOSS OF BONE TISSUE NEEDED FOR INTEGRATION".
WIRE PERFORATOR SEPARATED FROM PLASTIC HUB LEAVING WIRE PERFORATOR EMBEDDED IN BONE AND SOFT TISSUE OF MANDIBLE. WIRE WAS REMOVED BY GRASPING PROTRUDING PORTION WITH HEMOSTATS. WIRE PERFORATOR WAS REMOVED INTACT.
ONE DAY S/P PACEMAKER CHANGEOUT FOR BATTERY DEPLETION IT WAS NOTED THAT THERE WAS A LOSS OF CAPTURE AND SENSING. THE PT WAS SCHEDULED FOR LEAD REPLACEMENT. AFTER THE NEW LEADS WERE CONNECTED TO THE PACEMAKER, NO PACING OR SENSING WAS NOTED. A MAGNET WAS PLACED OVER THE DEVICE AND DID NOT ELICIT ASYNCHRONOUS PACING. THE PHYSICIAN ELECTED TO REPLACE THIS PACEMAKER WITH A LIKE AND SIMILAR DEVICE. MAGNET APPLICATION TO THE NEW DEVICE ELICITED ASYNCHRONOUS PACING.
CO SUBJECTED THIS UNIT TO A COMPLETE FINAL ACCEPTANCE TEST AND CONFIRM THAT THIS PACEMAKER IS NOT DEFECTIVE. THE OBSERVED BEHAVIOR OF THE PACEMAKER IS FULLY IN COMPLIANCE WITH SPECIFICATIONS: IN CASE OF SYNCHRONOUS PACING MODE, THE DEVICE WILL NOT PACE UNTIL THE PT'S INTRINSIC RATE DROPS BELOW THAT OF THE BASIC RATE OF THE PACEMAKER.
PT WAS DRAWN 7.8 POUNDS BELOW HIS TARGETED WEIGHT. MACHINE WAS CHECKED POST TX. UPON CLOSER EXAMINATION AFTER THE MACHINE HAD PASSED SEVERAL OTHER TESTS, RPTR DISCOVERED THE FLOW INDICATOR ONLY LEAKED UNDER POSITIVE PRESSURE. RPTR DISASSEMBLED THE FLOW INDICATOR, INSPECTED IT FOR DAMAGE, FOUND NONE, REASSEMBLED IT AND THEN RAN THE MACHINE TO TEST IT AND PUT POSITIVE PRESSURE ON IT. IT DID NOT LEAK ANY MORE. THE MACHINE WAS PLACED OUT OF SVC UNTIL RPTR RECEIVED THE UF PUMP FILTER HOUSING AS IT IS CRACKED ON THE OUTSIDE OF THE O-RING SEAL, HOWEVER IT IS NOT LEAKING.
THE ENTIRE MIDDLE POINT CAME OFF OF THE BAG, SPILLING THE TPN SOLUTION EVERYWHERE, DURING THE INITIATION OF THE CONTINUOUS INFUSION.
THE PRODUCT WAS USED DURING AN AXILLARY LIPOMA. THE SUTURE KNOTS DID NOT HOLD. THE SURGEON PERFORMED A REOPERATION TO RESUTURE THE WOUND. THE HOSP HAS REPORTED THAT THE PT STATUS IS SATISFACTORY.
5/30/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
A V-P SHUNT WAS IMPLANTED ON 7/31/96 IN A PT WHO HAD HYDROCEPHALUS AFTER SUBARACHNOID HEMORRHAGE. A REVISION WAS DONE 8/8/96 WITH A SHUNT FROM ANOTHER MFR BECAUSE THE PT'S VENTRICLE DID NOT REDUCE. THERE WAS NO CSF FLOW. THE VALVE PRESSURE SEEMED TO BE TOO HIGH. THERE WAS NO OCCLUSION CONFIRMED BY SHUNT GRAPH OR PUMPING. AT PRE-CHECK THE PERITONEAL CATHETER WAS CONFIRMED TO BE CORRECT. THE VENTRICULAR CATHETER WAS OPEN. THE PT WAS NOT INJURED AND HAS BEEN IN GOOD CONDITION AFTER THE REVISION.
VISUAL INSPECTION SHOWED THE THREE UNITS WERE ALL RECEIVED IN A DIFFERENT TYVEK POUCH, WHICH IS NOT IT'S ORIGINAL PACKAGE. A CLOSING PRESSURE TEST WAS PERFORMED ON THE VALVE PER INSTRUCTION ON DATA SHEET AND THE FOLLOWING RESULTS WERE OBTAINED: 23,20 AND 16MM H20. SPECIFICATIONS FOR A LOW VALVE IS 15-54MM H20., WHICH INDICATES THAT UNIT IS WITHIN PRESSURE SPECIFICATIONS. BASED ON THE ABOVE TEST RESULTS CO IS UNABLE TO CONFIRM CUSTOMER'S STATEMENT.
THE 25 YR OLD MALE PT WITH ITP RECEIVED HIS 5TH TREATMENT OF 2000 ML PLASMA ON 9/20/96. THE PROCEDURE WAS FINISHED AT 3:00 PM. THE PT DEVELOPED LEFT SIDE HEMIPARESIS AROUND 8:00 PM. THE PT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU), AND WAS DIAGNOSED CLINICALLY AS A DEEP THALMIC BLEED AND DECLARED DNR (DO NOT RESUSCITATE) AT 2:00 AM ON 9/21/96. PLATELET COUNTS HAD RANGED FROM 2000-3000 OVER THE COURSE OF THE FIVE TREATMENTS.
IS FREQUENCY OF OCCURRENCE OF THIS REPORT ADDRESSED IN THE DEVICE LABELING? NO. IF NO, IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? UNK. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IF NO, IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? UNK. MFR DID NOT RECEIVE A USER FACILITY REPORT FOR THIS EVENT.
THE RADIOGRAPHER WAS MOVING THE X-RAY COLLIMATOR INTO PLACE TO PERFORM A STUDY WHEN THE COLLIMATOR FELL FROM THE TUBE SUPPORT, NARROWLY MISSING A PT. WHEN THE SVC REP ARRIVED ON 10/8/96, IT APPEARED THAT THE THREADS HOLDING THE SCREWS FOR THE COLLIMATOR WERE STRIPPED OUT.
PT HAD ALLERGIC REACTIONS TO DISINFECTANT. CO TESTED THE LOT RETAINED SAMPLES AND FOUND THEM TO BE WITHIN SPEC. CO QUERIED SOURCE RELATIVE TO THE RINSING PROCEDURE THAT WAS EMPLOYED BY THE CLINIC, AND FOUND THAT THERE SEEMED TO BE SEVERAL ANOMOLIES IN THEIR PROCEDURE AMONGST WHICH WERE RECIRCULATION OF THE PRIMING SOLUTION AS OPPOSED TO DISCARDING OF SAME. WHEN PRIMING SOLUTION IS NOT DISCARDED, THE USER RUNS A RISK OF HAVING DISINFECTANT PASSING INTO THE BLOOD COMPARTMENT WHICH WOULD LEAD TO A REBOUND CONDITION; I.E., THE DISINFECTANT COULD BE PASSED ON TO THE PT WHEN DIALYSIS COMMENCES. A FOLLOW UP CALL WAS MADE ON 8/19/96 TO DETERMINE THE OUTCOME OF THE MODIFIED PROCEDURE. ON 8/15/96 AND 8/16/96, ALL WENT WELL BUT ON 8/19/96, THEY EXPERIENCED FURTHER MINOR ALLERGIC REACTIONS. CO DECIDED THAT A MORE COMPREHENSIVE INVESTIGATION WAS REQUIRED, AND THEREFORE DISPATCHED THE TECHNICAL MANAGER TO VISIT THE CLINIC ON THE FOLLOWING DAY, 8/20/96. ON 8/20/96 A COMPREHENSIVE STUDY WAS MADE ON THE WHOLE RINSING PROCEDURE EMPLOYED BY THE CLINIC, AND PRIOR TO THE VISIT, THE CLINIC FELT THAT THEIR RINSING PROCEDURES NEEDED TO BE WRITTEN TO REFLECT CHANGES IN THE WHOLE PROCEDURE. AFTER THE STUDY WAS COMPLETED, CO REVIEWED THE NEW RINSING PROCEDURE. ON THAT DAY, 8/20/96, AND 8/21/96, THE CLINIC PROCEEDED TO EMPLOY THE NEW PROCEDURES SUGGESTED BY CO AND MFR OF DIALYSIS SYSTEM, AND THEY FOUND THAT THE NEW SYSTEM WORKED WELL. THESE NEW PROCEDURES WILL BE WRITTEN INTO THEIR S.O.P.'S AND ALL PERSONNEL WILL BE TRAINED APPROPRIATELY. CO WILL FOLLOW UP WITHIN A WEEK TO DETERMINE THE CLINIC'S PROGRESS.
H10: "F" SECTION; MFR ADVISED CLINIC TO SEND IN THEIR MEDWATCH #3500A REPORT TO THE AGENCY AND THE MFR IS SENDING IN THEIR OWN. MFR IS NOT QUALIFIED TO FILL OUT SECTION F OF THE FORM #3500A. H11: RELATIVE TO "D10", COCOMITANT MEDICAL PRODUCTS ARE LISTED AND THERE ARE NO THERAPY DATES KNOWN. "A3" & "A4" ARE UNK.
THE 7.3 CANNULATED TAP SHEARED OFF WHEN SCREWING INTO THE BONE SHAFT. THE SURGEON LEFT A PORTION OF THE TAP IN THE BONE.
5/30/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. DEVICE EVALUATION AND CODES ENTERED IN H3 AND H6.
THE BASKET PORTION OF THE DEVICE SEPARATED FROM THE CABLE AND BECAME TRAPPED IN THE GRAFT. A SNARE CATHETER WAS USED TO REMOVE THE BASKET PORTION FROM THE GRAFT. THERE WERE NO PT COMPLICATIONS.
THE SYSTEM IS AN AUTOMATED CERVICAL CYTOLOGY RE-SCREENING DEVICE INTENDED FOR USE IN THE QUALITY CONTROL AND RE SCREENING OF PREVIOUSLY SCREENED PAPANICOLAOU (PAP) SMEAR SLIDES. USED AS INTENDED THE SYSTEM WILL IDENTIFY A SUBSET OF MANUAL SCREEN NEGATIVE PAP SMEAR SLIDES WHERE THE SPECIMEN IS POTENTIALLY ABNORMAL. THE DEVICE WILL RANK ALL REVIEWED SLIDES IN ORDER OF POTENTIAL FOR ABNORMALITY. THE USER WILL SET THE THRESHOLD, GENERALLY A 10% OR GREATER REVIEW RATE OF ALL SLIDES PROCESSED, FOR IDENTIFYING SLIDES THAT WILL NEED MANUAL RE-SCREENING. A SVC ACTION, TO THE DEVICE INVOLVED IN THIS INCIDENT, UNINTENTIONALLY RESULTED IN A REVIEW RATE OF 1.1 % . THE SVC ACTION, OCCURRING ON SEPT 2ND WAS TO REPLACE THE IMAGE SYSTEM. IN ORDER TO FUNCTION CORRECTLY, THE SYSTEM REQUIRES REQUALIFICATION WHEN A SVC ACTION SUCH AS THIS IS PERFORMED. RE QUALIFICATION DID NOT OCCUR IN THIS INCIDENT, AND AS A RESULT, THE USER PROCESSED THEIR MANUAL SCREEN NEGATIVES AT A 1.1% REVIEW RATE. THIS IS THE RATE THE UNIT DEFAULTED TO WITH THE NEW, UNQUALIFIED IMAGE SYSTEM. THE USER CONTINUED PROCESSING SPECIMENS IN THIS MANNER FOR SEVERAL WEEKS. UPON REVIEW OF THEIR DATA, THE USER NOTICED THAT THE THRESHOLD WAS LOW. A SVC CALL CONFIRMED THE PROBLEM AND THE SYSTEM WAS REQUALIFIED WITH THE NEWLY REPLACED IMAGE SYSTEM. THE USER REQUESTED THE THRESHOLD TO BE SET AT A 15% REVIEW RATE. TO RESOLVE SPECIMEN RESULTS GENERATED UNDER THE LOWER THRESHOLD, CO'S APPLICATION ENGINEERING ACCESSED THE HISTORICAL DATA FOR ALL SPECIMENS PROCESSED SINCE THE IMAGE SYSTEM WAS REPLACED. CO SENT THE USER A LISTING OF THESE SPECIMENS RANKED IN ORDER OF POTENTIAL FOR ABNORMALITY. WITH THIS LIST, THE USER WAS ABLE TO MANUALLY RE-SCREEN THE DESIRED PERCENTAGE OF MANUAL SCREEN NEGATIVES (ARCHIVED AT USER-SITE). DUE TO CONCERNS SURROUNDING CONFIDENTIALITY OF INTERNAL POLICY, THE CUSTOMER WAS UNWILLING TO SHARE THE RESCREENING RESULTS WITH CO. THE CUSTOMER DID CONFIRM THAT THEY WERE ABLE TO USE THE LIST PROVIDED BY CO RESCREEN SPECIMENS PROCESSED DURING SEPTEMBER AT A 15% REVIEW RATE.
MFR PREPAIRED SECTION F. EVENTS CODED IN SECTION F10 ARE DESCRIBED IN LABELING.
THE PRODUCT WAS USED DURING A CLOSURE OF THE GASTRIC POUCH. THE SUTURE BROKE AND THE KNOTS DID NOT HOLD. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/29/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
CO WAS NOTIFIED OF EVENT AFTER THE FACT - INITIAL REPORT DID NOT MENTION BED AND RAIL. PER REPORT RAIL WAS LATCHED IN UP POSITION; IT WAS THE FACILITY'S FEELING THAT THE RAIL AND BED WERE IN GOOD OPERATING CONDITION AND MATTRESS OVERLAY DEVICE MAY HAVE CONTRIBUTED TO RESIDENT GETTING HIS BODY WEDGED BETWEEN BED RAIL AND MATTRESS. CO IS CURRENTLY EVALUATING SPACE BETWEEN VERTICAL BARS.
10/21/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
IT WAS REPORTED THAT FIVE MINUTES AFTER THE START OF THE HEMODIALYSIS TREATMENT, THE PT EXPERIENCED SWELLING OF THE EYELIDS, LIPS AND HAD LARYNGEAL EDEMA. THE PT WAS GIVEN MEDICATIONS, THE TREATMENT WAS STOPPED, AND THE BLOOD RETURNED. DIALYZER WAS 3RD USE.
THERE ARE MANY CLINICAL INFLUENCES WHICH CAN AFFECT HOW A PT REACTS TO A DIALYZER, SUCH AS PROCESSING SOLUTIONS, MEDICATIONS, PRIMING PROCEDURE OF THE DIALYZER, PT SENSITIVITIES TO PARTICULAR MEMBRANES, OR PT MEDICAL CONDITION OTHER THAN RENAL DISEASE. AS INDICATED IN THE LABELLING, CO'S DIALYZERS ARE STERILE AND NON-PYROGENIC IN THE SEALED, STERILE PACKAGE. THE FACTORY HAS BEEN INFORMED OF THIS OCCURRENCE AND HAS DOCUMENTED THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT.
AFTER INSERTION, THE GUIDEWIRE COULD NOT BE REMOVED FROM THE CATHETER. THE CATHETER TRACKED OVER THE WIRE FINE, BUT IT COULD NOT BE REMOVED. THE ENTIRE DEVICE WAS REMOVED AND ANOTHER CATHETER WAS INSERTED. THERE WERE NO PT COMPLICATIONS.
CO'S EVALUATION FOUND THAT THE WIRE GUIDE HAD UNRAVELLED AND WAS WEDGED IN THE CATHETER LUMEN. THERE WAS NO INDICATION OF ANY MATERIAL OR MFG DEFICIENY.
ACCOUNT REPORTED THAT THREE NEURO PRODUCTS WERE REMOVED FROM PT SUCCESSFULLY DUE TO MALFUNCTION. THE PHYSICIAN REPORTED THAT THE VALVE WAS TESTED PRIOR TO IMPLANT. RESULTS WERE LOW. THE VALVE WAS IMPLANTED AND THE SHUNT WORKED. THE PT HAD NORMAL PRESSURE HYDROCEPHALUS. THE VENTRICLES WERE NOT COMING DOWN TO SIZE AS QUICKLY AS NORMAL. PT WAS NOT DOING WELL. A RADIONUCLEAR TYPE STUDY SHOWED THE SHUNT WAS WORKING. THE SHUNT WAS TAPPED. PRESSURE WAS TOO HIGH.
H3: END USER DID NOT RELEASE PRODUCT FOR MFR'S TESTING PURPOSES. H6: METHOD CODE 86. DEVICE HISTORY RECORDS REVIEWED. H6: CONCLUSION CODE 67. DEVICES WERE NOT RETURNED. NO CONCLUSION CAN BE DRAWN.
THE VALVE WAS DEFECTIVE AND HAD BEEN EXPLANTED FROM THE PT. THE VALVE SPECIFICATIONS NEED TO BE RE-CHECKED.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUALEXAMINATION: AN OSV WITHOUT THE ORIGINAL PACKAGING WAS RECEIVED. THE UNIT WAS CUT AT THE END OF THE DRAINAGE CATHETER. FUNCTIONAL TESTING: UPON RECEIPT, THE VALVE WAS FOUND TO BE PARTIALLY OBSTRUCTED. THE UNIT WAS TESTED IN TUBING SINCE THE DRAINAGE CATHETER HAD BEEN CUT AT THE END OF THE SILICONE BOOT. THE PRESSURE/FLOW CHARACTERISTICS WERE TESTED AND THE RESISTANCE AND FLOW REGULATION VALUES WERE FOUND TO BE OUT OF SPECIFICATION. MICROSCOPIC EXAMINATION: THE VALVE'S CORE WAS EXAMINED LIGHT OPTICALLY AND REVEALED THE PRESENCE OF RESIDUE AROUND THE PIN. THE RESIDUE HAD THE APPEARANCE OF PROTEINACEOUS MATTER. THE CAUSE FOR THE VALVE'S NON-FUNCTIONAL CONDITION, UPON RECEIPT IN THE TEST LAB, HAS BEEN ATTRIBUTED TO THE PRESENCE OF THE RESIDUE ADHERING TO THE VALVE MECHANISM. ALTHOUGH THE EXACT CAUSE FOR THE DIFFICULTY EXPERIENCED DURING CLINICAL USE COULD NOT BE DETERMINED, VALVE OBSTRUCTION DUE TO THE PRESENCE OF PROTEINACEOUS MATTER IS A KNOWN COMPLICATION OF VALVE THERAPY AS IS INDICATED IN THE CO'S INSTRUCTIONS FOR USE.
A 19 YR OLD MALE PT WAS ON ECMO SUPPORT. AFTER 22 HOURS OF SUPPORT, THE DEVICE (S/N 1483049) EXHIBITED PLASMA BREAK THROUGH AND WAS CHANGED OUT. AFTER 30 HOURS OF SUPPORT, A SECOND DEVICE S/N 1480912 WAS CHANGED OUT FOR PLASMA BREAKTHROUGH. THE THIRD DEVICE S/N 1549251 EXHIBITED PLASMA BREAKTHROUGH AFTER 30 HOURS. ECMO IS AN OFF LABELED USE OF THE DEVICE. THE DEVICE IS DESIGNED AND LABELED TO OPERATE FOR A MAXIMUM PERIOD OF 6 HOURS. INFO REC'D INDICATED THAT SUPPORT WAS DISCONTINUED DUE TO PT'S BAD CONDITION (MULTI-TRAUMA FROM CAR ACCIDENT).
TESTING ON RETURNED DEVICES (S/N'S 1480912 AND 1483049) NOTED PLASMA BREAKTHROUGH. THE OXYGENATORS WERE REC'D ON 10/21/96 FOR EVAL. THE RETURNED DEVICES WERE SET UP IN A SIMULATED PERFUSION CIRCUIT FOR TESTING UNDER THE OBSERVATION OF A TECHNICIAN. SERIAL NUMBER 1483049 WAS PLACED IN THE PERFUSION CIRCUIT FOR TESTING. PLASMA BREAKTHROUGH WAS NOTED AT 6 HRS OF TESTING. SERIAL NUMBER 1483049 WAS PLACED IN THE PERFUSION CIRCUIT FOR TESTING. PLASMA BREAKTHROUGH WAS NOTED AT 6 HOURS OF TESTING. SERIAL NUMBER 1480912 WAS PLACED IN THE PERFUSION CIRCUIT FOR TESTING. PLASMA BREAKTHROUGH WAS NOTED AT 5.5 HOURS OF TESTING. SERIAL NUMBER 15492521 WAS PLACED IN THE PERFUSION CIRCUIT FOR TESTING. NO PLASMA BREAKTHROUGH WAS OBSERVED DURING THE 6 HOURS EVAL. THE EFFLUENT WAS COLLECTED FROM SERIAL NUMBERS 1483049 AND 1480912 AND A SPECIFIC GRAVITY ANALYSIS WAS CONDUCTED FOR EACH SAMPLE. THE RESULTS INDICATED THAT THE SPEC GRAVITY WAS WITHIN THE KNOWN LIMITS OF PLASMA. THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIV BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIV, ITS OFFICERS, EMPLOYEES, OR AGENTS.
THE DOCTOR OBSERVED A SUDDEN "POOF" OF SMALL METAL PARTICLES ENTERING THE EYE WHILE PERFORMING A ROUTINE PHACOEMULSIFICATION PROCEDURE. THE NURSE INDICATED THAT THE TIP HAD BEEN IRRIGATED PRIOR TO USE. MOST OF THE PARTICLES WERE EXTRACTED FROM THE EYE, HOWEVER, THEY WERE NOT SAVED. THERE WAS NO HARM TO THE PT. THE TIP AND HANDPIECE ARE NOT AVIALABLE FOR EVAL AT THIS TIME.
A PT HAD GAINED 1.5 KG OF FLUID DURING A DIALYSIS TREATMENT. THE FACILITY REPORTS THAT THE MACHINE HAD PASSED THE PRETREATMENT TESTING. THE PT WAS DIALYZING ON A HIGH FLUX DIALYZER. THE FACILITY STATED THE TMP ALARM LIMITS WERE SET PLUS OR MINUS 50MMHG AROUND THE INITIAL TMP OF 70MMHG. THE MFR RECOMMENDATIONS STATED IN THE DEVICE LABELING, ARE TO SET THE TMP ALARM LIMITS PLUS OR MINUS 20MMHG FOR HIGH FLUX DIALYSIS. THE FACILITY STATES THAT TMP ALARMS HAD OCCURRED DURING THE TREATMENT AND WERE RESET UNTIL THE TMP STABILIZED AT 40MMHG. THE PT HAD BECOME SHORT OF BREATH, DIAPHORETIC, FACE WAS SWELLING, COUGHING WHITE FROTHY SPUTUM, BP 202/98. THE PT WAS PUT ON OXYGEN, HAD A EKG AND BREATHING TREATMENT DURING THE DIALYSIS. ULTRAFILTRATION WAS INCREASED AND THE TREATMENT CONTINUED. THE HOSP BIOMED DEPT INSPECTED THE MACHINE AND STATED THEY FOUND NOTHING WRONG WITH THE MACHINE. THE MANUFACTURER ON SITE INSPECTION OF THE MACHINE ALSO COULD NOT FIND ANYTHING WRONG WITH THE MACHINE. BUT THE MFR REPRESENTATIVE DID UNCOVER SPECULATION BY THE MACHINE OPERATORS THAT THE BIO-MED DEPT HAD REPLACED A VALVE. THIS INFO COULD NOT BE VERIFIED. THE CAUSE OF THIS EVENT CAN NOT BE DETERMINED.
MFR ON SITE INSPECTION ALSO COULD NOT FIND ANYTHING WRONG WITH THE MACHINE. BUT MFR DID UNCOVER SPECUALTION BY OPERATORS THAT BIO-MED DEPT HAD REPLACED A VALVE. THIS INFO COULD NOT BE VERIFIED. THE CAUSE OF THIS EVENT CAN NOT BE DETERMINED.
CUSTOMER STATES THAT HE USED CONDOMS EACH TIME HE ENGAGED IN INTERCOURSE. HIS GIRLFRIEND BECAME PREGNANT. HE STATES THAT HE DID NOT EXPERIENCE ANY PROBLEMS WITH THE CONDOMS (NO HOLES, SLIPPAGE, BREAKAGE, ETC).
MFR RECEIVED A REPORT FROM AN ATTORNEY ALLEGING A CANE BROKE AND RESULTED IN VARIOUS NEUROLOGICAL INJURIES. EVALUATION OF THE CANE INVOLVED IN THIS INCIDENT BY THE MFR HAS NOT BEEN PERMITTED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED TOTAL VAGINAL HYSTERECTOMY PROCEDURE. THE PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/21/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. DUE TO CLERICAL ERROR, THE STATUTORY MDR FILING DATE WAS MISSED.
SOAP EJECTOR WAS CLOGGED. INSTEAD OF WATER FLOWING THROUGH EJECTOR SIPHONING DETERGENT FROM CONTAINER, THE WATER FLOWED INTO THE SOAP CONTAINER AND OVERFLOWED SPILLING SOAPY WATER ONTO THE FLOOR. OPERATOR SLIPPED ON FLOOR BRUISING RIGHT ELBOW AND HIP. ALSO HIT HEAD ON FLOOR. THIS WAS A MINOR INJURY, BUT COULD HAVE BEEN A SERIOUS INJURY.
CO TECH REPLACED SOAP EJECTOR, TESTED UNIT; UNIT IS OPERATING CORRECTLY ON 10/3/96.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
TWO LEADS WERE REMOVED FROM SVC. THE FORM STATED "FRACTURED LEADS IN POCKET", ADD'L INFO STATED THE LEADS APPEARED TO HAVE "INSULATION RUB ABRASION." THE LEADS WERE REPLACED WITH A NEW RATE SENSING LEAD.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALLUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON LOW IMPEDANCE. NO FURTHER INFO IS AVAILABLE.
DURING A POLYP REMOVAL PROCEDURE USING A BICAP GENERATOR, POWER REPORTEDLY SURGED FROM 25 TO 35 WATTS; PT SUSTAINED A PERFORATED COLON.
THE SUBJECT INSTRUMENT WAS NEVER RETURNED TO CIRCON. NO FURTHER INFO IS AVAILABLE AS TO MODEL NUMBER, LOT NUMBER, CATALOG NUMBER, OR SERIAL NUMBER. INSUFFICIENT INFO UPON WHICH TO BASE A FREQUENCY OF OCCURRENCE OR SEVERITY OF OCCURRENCE STATEMENT.
DURING A CODE: PADS ARE TEARING APART. FEMALE AGE 87 WAS HAVING TROUBLE BREATHING. CPR WAS STARTED, UNIT WAS HOOKED UP AND PADS WERE TEARING APART INCORRECTLY. PT WAS TRANSPORTED TO A HOSP STATUS OF PT IS UNKNOWN. NO PADS WILL BE RETURNED FOR EVAL.
THE PRODUCT WAS USED DURING A LAPAROSCOPIC HERNIA PROCEDURE. THE TIP OF THE INSTRUMENT DISENGAGED INTO THE PT'S CAVITY. THE COMPONENT WAS RETRIEVED LAPAROSCOPICALLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
TIP OF BALL OF ELECTRODE SEPARATED IN PT AND HAD TO BE RETRIEVED.
INSUFFICIENT INFO AVAILABLE TO DETERMINE CAUSE OF REPORTED PROBLEM.
PHYSICIAN REMOVED TRACHEOSTOMY TUBE TO CHANGE IT DUE TO KINK, UNABLE TO REINSERT TRACH. PT WAS INTUBATED (ALL TESTS FOR PROPER POSITION DONE) RT UNABLE TO VENTILATE WITH BAG, 2 COMPRESSIONS THEN NEEDED TO REMOVE BAG FROM ET TO ALLOW EXHALE, MUCH RESISTANCE WITH EACH SQUEEZE. PT ARRESTED AND CPR BEGAN. SHORTLY AFTER CPR START BAGGING BECAME EASY. VITAL SIGNS RESUMED AFTER ABOUT 30 MIN OF CPR, BUT NEUROLOGIC IMPAIRMENT NOTED. BRAIN DEATH ESTABLISHED AND SUPPORT WITHDRAWN ON 10/10. EVENTS REVIEWED WITH PHYSICIAN AND RT SPECULATION OF FAULTY EXHALE VALVE ON BAG. PEEP VALVE HAD BEEN REMOVED WITHOUT EFFECT ON ABILITY TO BAG OR EXHALE.
CONFINED ANEURYSM OCCURRED ON THE AORTIC ARCH DURING INFLATION PERIOD. DR USES A 20CM METAL FOR MEASUREMENT ON CINE (FILMS). ACCORDING TO DR. THE BALLOON APPEARED TO MEASURE 18CM.
NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. THERE WAS NOT ENOUGH INFO SUPPLIED FROM THE USER FACILITY TO VERIFY THAT A MALFUNCTION OCCURRED. ADD'L INFO HAS BEEN REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED IF ANY ADD'L INFO BECOMES AVAILABLE.  DISCLAIMER: B BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REOPRTING) DATED 12/11/95. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED EVENT ACTUALLY CAUSED TO CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CASUAL RELATIONSHIPS TO DEVICES MANUFACTURED OR DISTRIBUTED BY B BRAUN MEDICAL INC.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT FIRED TWO CLIPS AT ONCE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
HOSP SUBMITS THE FOLLOWING REPORT PURSUANT TO 21 CFR PART 803. THIS REPORT IS BASED ON INFO REVIEWED BY HOSP WHICH HOSP MAY NOT HAVE HAD AN OPPORTUNITY TO INVESTIGATE FULLY OR VERIFY PRIOR TO THE REPORTING DATE. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY HOSP THAT IT OR ANY OF ITS EMPLOYEES OR AFFILIATES CAUSED OR CONTRIBUTED TO THE INCIDENT DESCRIBED HEREIN. PT IN END STAGE CARDIOMYOPATHY AWAITING HEART TRANSPLANT. ON 9/5/96 HE HAD LVAD IMPLANTED. ON 9/17/96 STAFF NOTED INAPPROPRIATE CHANGE IN CONSOLE FUNCTION. CHANGE TO BACKUP CONSOLE WITH SAME RESPONSE. DRIVE LINE/GRAY SENSOR CHANGED WITH NO CHANGE. CO NOTIFIED, FELT PROBLEM NOT WITH CONSOLE OR EXTERNAL SYSTEM BUT WITH INTERNAL BLOOD PUMP. PT TO OR FOR EXPLANT AND IMPLANT OF NEW DEVICE.
CUSTOMER REPORTED THEY FELT THE OUTPUT OF THE VAPORIZER WAS LOWER THAN NORMAL. THERE WAS NO REPORTED PT INJURY. CO'S INVESTIGATION INTO THE REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
INVESTIGATION/CONCLUSION: THE UNIT WAS RETURNED TO THE MFG SITE FOR INVESTIGATION. THE UNIT WAS TESTED AND THE REPORTED COMPLAINT WAS CONFIRMED. THE INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THE REPORTED COMPLAINT WAS DUE TO SCRATCHING AND/OR FLATNESS ISSUES RELATED TO THE SEALING FACE OF THE ROTARY VALVE. CHANGES IN MFG PORCESSES HAVE GREATLY REDUCED THESE ISSUES. CHANGES WERE IMPLEMENTED INTO THE MFG, REFURBISHING AND SVC PROCESSES IN 6/97.
CATHETER PERFORATED PROXIMAL SECTION OF THE FALLOPIAN TUBE DURING A FALLOPOSCOPY PROCEDURE. THIS IS AN ANTICIPATED ADVERSE EVENT AS INDICATED IN THE PRODUCT LABELING. THE ADVERSE EVENT IS MARKED "OTHER" BECAUSE IT IS UNKNOWN AS TO WHETHER THE ADVERSE EVENT RESULTS IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE.
DURING AN UNSPECIFIED PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE SHAPING RIBBON SHEARED OFF THE WIRE AND WAS LEFT IN THE PT. THE SHAPING RIBBON SHEARED OFF THE WIRE AND REMAINED IN VIVO. ADD'L INFO THAT WAS PROVIDED TO CO INDICATED THAT THE STABILIZER WAS BEING USED WITHIN WHAT WAS THOUGHT TO BE A "SOFT" TOTAL OCCLUSION. DIFFICULTY WAS EXPERIENCED DURING ATTEMPTS TO CROSS THE LESION AND THE WIRE SEPARATED. NO COMPLICATIONS WERE REPORTED NOR ANTICIPATED SINCE THE WIRE FRAGMENT REMANS ENTRAPPED WITHIN THE TOTAL OCCLUSION. THE PT'S CONDITION WAS REPORTED AS SATISFACTORY.
VISUAL EXAMINATION: UPON RECEIPT, THE DISTAL END OF THE RETURNED GUIDEWIRE WAS FOUND TO BE FRACTURED. THE MOST DISTAL SEGMENT OF THE WIRE WAS NOT RETURNED FOR EXAMINATION. APPROX. 2.4 CM OF THE BLACK PTFE SLEEVING WAS FOUND EXTENDED DISTALLY OVER THE FRACTURED WIRE. THE SLEEVE WAS TWISTED AT ITS PROXIMAL END, WITH TRACES OF DRIED BLOOD EVIDENT. DIMENSIONAL EXAMINATION: THE TOTAL LENGTH OF THE RETURNED GUIDEWIRE MEASURED 295 CM. MICROSCOPIC EXAMINATION: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED THE PRESENCE OF A SLIGHT CIRCULAR ARRAY ON THE FRACTURE SURFACE WITH A TRANSVERSE FRACTURE PLANE. IT IS BELIEVED THAT THE GUIDEWIRE FRACTURED DUE TO TORSIONAL OVERLOADING WITH SOME ACOMPANYING TENSILE FORCE. THERE WERE NO INDICATIONS OF ANY MATERIAL OR MANUFACTURING DEFECTS. TORSIONAL OVERLOADING LEADING TO FRACTURE AT THE LOCATION ON THE WIRE (PROXIMAL TO THE RADIOPAQUE COIL), WOULD BE HIGHLY UNLIKELY, UNLESS THE WIRE WAS TRAPPED JUST DISTAL TO THIS LOCATION. AS INDICATED BY THE PHYSICIAN, THE DISTAL END OF THE RADIOPAQUE COIL WAS LOCATED DISTAL TO THE OCCLUSION WHEN THE WIRE WAS STUCK. HE FURTHER INDICATED THAT, IN HIS ATTEMPTS TO DISLODGE THE WIRE FROM THE TOTAL OCCLUSION, HE HAD TORQUED AND PULLED THE WIRE. THIS IS THE FIRST REPORTED FRACTURE OF THIS NATURE FOR ANY OF THE FAMILY OF RADIOLUCENT GUIDEWIRES.
DEVICE WAS BEING UTILIZED FOR A VENOUS THROMBOLYSIS. THE CATHETER WAS ADVANCED VIA THE RIGHT GROIN ACROSS THE BIFURCATION. THE PHYSICIAN WENT TO EXCHANGE THE CATHETER AND UPON REMOVAL OF THE CATHETER, HE NOTED THE TIP HAD SEPARATED. IT WAS DETERMINED FROM FLUOROSCOPY THE CATHETER TIP HAD FLOATED UP TO THE RIGHT ATRIUM. THE SEPARATED TIP WAS SUBSEQUENTLY RETRIEVED.
CO RECEIVED TWO PARTS OF THE PRODUCT FROM THE CUSTOMER. THE FIRST IS THE MAIN BODY OF THE CATHETER, APPROX. 60CM IN LENGTH WITH APPROX. FIVE (5) MM OF BEACON TIP MATERIAL AT THE DISTAL END.  THE SECOND PIECE IS THE MAIN DISTAL TIP WHICH IS MADE OF BEACON TIP MATERIAL. IT IS APPROX. 23MM IN LENGTH. INVESTIGATION REVEALED THAT THE PRODUCT WAS MFG ACCORDING TO SPECIFICATIONS. AT THIS TIME CO IS UNSURE AS TO WHY THE TIP SEPARATED FROM THE MAIN BODY OF THE CATHETER. CO HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS MATTER AND ARE AURRENTLY INVESTIGATING TO ASSURE THIS SITUATION DOES NOT RECUR.
TRACH PLACED SURGICALLY 10/4/96 DUE TO INABILITY TO WEAN FROM VENTILATOR. NURSES UNABLE TO PASS SUCTION CATH ON 10/8, PT REQUIRED FREQUENT SUCTIONING. PHYSICIAN REMOVED TRACH, UNABLE TO INSERT A REPLACEMENT. DESCRIBES VISIBLE "KINK" IN TUBE, ALSO VISIBLE ON CXR. SEVERAL ATTEMPTS TO INSERT NEW TRACH, THEN DECISION TO INTUBATE TO PRESERVE RESPIRATORY STATUS. ET PLACED WITH EASE, RT UNABLE TO VENTILATE WITH MANUAL RESUS BAG. PT ARRESTED, CPR X 30 MIN BEFORE VITAL SIGNS RESUMED, BUT PT NEUROLOGICALLY IMPAIRED. SUPPORT WITHDRAWN AND DEATH DECLARED 10/10/96.
10/21/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFR.
DURING AN INFUSION AIR WAS NOTED IN THE TUBING TO THE PT. THERE WAS NO RESULTANT PT COMPLICATION.
THE PUMP AND THE SET WERE RETURNED FOR EVALUATION. THE SET WAS EXAMINED UNDER HIGH MAGNIFICATION. THE TUBING WAS FOUND TO HAVE A HORIZONTAL CUT IN THE TUBING APPROX 20 INCHES BELOW THE DRIP CHAMBER. THE PUMP MECHANISM WAS EXAMINED UNDER MAGNIFICATION AND NO SHAR EDGES WERE NOTED AND THE MECHANISM WAS FOUND TO BE CONSISTENT WITH AN ORIGINAL MANUFACTURED MECHANISM. THERE WERE NO DEFECTS NOTED ON THE PINCHER THAT WOULD HAVE CONTRIBUTED TO THIS TYPE OF DAMAGE OF THE SET. THE TUBING APPEARED TO HAVE BEEN PINCHED BETWEEN TWO HARD SURFACES. THE EXACT CAUSE IS UNK. SINCE THE AIR WAS DRAWN INTO THE SET AFTER PRIMING, THE HOLE IS NOT BELIEVED TO HAVE BEEN DUE TO A MANUFACTURING DEFECT. IT IS POSSIBLE THAT THE TUBING WAS SUBJECTED TO A SINGLE OVER STRESSED EVENT DURING WHICH THE TUBING WAS STRETCHED OVER THE EDGE OF THE PINCH OFF MECHANISM TO THE POINT OF FAILURE.
PT UNDERGOING EMBOLIZATION OF INTERNAL MAXILLARY CAROTID ARTERY. EMBOLIZATION OF A 3 MM COIL INTO THE LEFT MIDDLE CEREBRAL ARTERY.
PT BROUGHT INTO ER IN CARDIAC ARREST DUE TO DRUG OVERDOSE. ATTEMPTED TO PACE UNSUCCESSFULLY DUE TO WRONG PADS. CHANGED TO PROPER PACING PADS, BUT PACER MA WAS NOT BROUGHT HIGH ENOUGH TO CAPTURE UNTIL 6 MINS INTO THE CODE. PT EXPIRED.
H6-NO PRODUCT WAS RETURNED FOR EVALUATION. BASED ON THE INFO PROVIDED CO UNSURE AS TO WHAT THE EXACT PRODUCT THAT WAS USED AND WHY THE ACCIDENTAL EMBOLIZATION TOOK PLACE.
THE LUER BROKE AFTER CONNECTING TO A NEEDLELESS VALVE AND PT LOST 50CC OF BLOOD. THERE WERE NO PT COMPLICATIONS.
THE TWO PIECE LUER WAS VISUALLY INSPECTED AND WAS FOUND TO HAVE BROKEN OFF INSIDE THE VALVE. THE SURFACE OF THE CRACKED LUER WERE WHITTENED, INDICATING THE PART HAD BEEN STRESSED. IMPROPER CONNECTION (OVER TIGHTENING) MAY CAUSE THIS TYPE OF DAMAGE TO THE LUER. PROPER TECHNIQUE HAS BEEN STRESSED TO THE HOSPITAL TO REDUCE THE OCCURRANCE OF BREAKING LUERS. FINAL REPORT DATE 11/6/96.
DURING AN UNSPECIFIED PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
X-RAY MACHINE TOOK AN EXPOSURE WITHOUT BEING ACTIVATED BY OPERATING BUTTON. USE OF OPERATING BUTTON IS TO PREVENT EXPOSURE TO OTHERS IN ROOM OR PT UNNECESSARILY. PT ONLY RECEIVED THE EXPECTED EXPOSURE, DESPITE TECHNOLOGICAL PROBLEM. OPERATOR HAD PRESSED BUTTON WITH NO RESPONSE. UPON ASSESSING SYSTEM TO DETERMINE ISSUE, SYSTEM DISCHARGED BY SELF, WITHOUT PROMPT.
PT RECEIVED A SHOCK DURING A GYNECOLOGICAL PROCEDURE. ACCORDING TO THE BIOMEDICAL ENGINEER, THE GROUNDING PAD WAS INADVERTENTLY NOT CONNECTED TO THE GENERATOR WHEN THE GENERATOR WAS ACTIVATED.
AS STATED IN THE ORIGINAL REPORT, THE USER ADMITTED THAT THE UNIT WAS OPERATED INCORRECTLY IN THAT THE GROUNDING PAD WAS NOT ATTACHED TO THE GENERATOR WHEN THE GENERATOR WAS ACTIVATED. THE USER STATED THAT THE PATIENT RECEIVED A SHOCK WHEN THE UNIT WAS ACTIVATED. UPON RECEIPT OF THE UNIT, IT WAS TESTED ACCORDING TO THE USERS MANUAL WITH PARTICULAR ATTENTION PAID TO THE EXPECTED WARNING LIGHT AND OUTPUT POWER SHUT OFF WHEN THE GROUNDING PAD WAS DISCONNECTED. IN ALL CASES, WHEN THE GROUNDING PAD WAS DISCONNECTED, THE WARNING LIGHT WAS OBSERVED TO LIGHT AND THE OUTPUT POWER CEASED. THE SITUATION THAT THE USER EXPERIENCED COULD NOT BE DUPLICATED. THIS MODEL OF ELECTROSURGERY GENERATOR IS GROUND REFERENCED. IT IS POSSIBLE TO DELIVER POWER TO THE PATIENT IF THE GROUNDING PAD IS CONNECTED TO THE GENERATOR BUT NOT TO THE PATIENT AND THE PATIENT IS AT GROUND POTENTIAL. IT MAY BE THAT THIS WAS THE ACTUAL CONFIGURATION AT THE TIME OF THE INCIDENT, AND NOT AS INITIALLY REPORTED. THE UNIT PERFORMS EXACTLY AS DESIGNED IN SUCH A SITUATION.
A BALLOON CATHETER LEAKED AFTER THE FIRST INFLATION. A SECOND BALLOON CATHETER WAS USED AND THERE WERE NO PT COMPLICATIONS. CO'S ATTEMPTS TO GAIN FURTHER INFO SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL. DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL CONFIRMED A HOLE IN THE DISTAL SHOULDER OF THE BALLOON. HOWEVER, WITHOUT FURTHER INFO REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. DIRECTIONS FOR USE STATE: "DO NOT EXCEED THE NORMAL PRESSURE PRINTED ON THE PRODUCT LABEL. NEVER MANIPULATE THE CATHETER WITH THE BALLOON INFLATED... THE INTEGRITY OF ALL BALLOON CATHETERS MAY BE COMPROMISED BY SHARP OBJECTS OR SURFACES. NOT RECOMMENDED FOR USE IN CALCIFIED LESIONS."
DURING AN UNSPECIFIED THYROID PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING ATTEMPT TO TREAT PT THE CABLE WOULD NOT PROVIDE DISCHARGE OF THE DEFIBRILLATOR. DEVICE RETURNED TO MFR FOR EVALUATION AND FAILURE COULD NOT BE REPRODUCED.
DEVICE RETURNED TO MFG FOR EVALUATION AND FAILURE COULD NOT BE REPRODUCED.
END USER STATED THAT HER DEVICE WAS MAKING LOUD POPPING NOISES OUT OF THE REAR WHEELS. SHE SAID SHE HAD THE WHEELS REPLACED ONCE BEFORE. SHE ALSO STATES THAT THE JOYSTICK IS STICKING AND THE CHAIR WANTS TO RUN ON ITS OWN.
WAITING FOR RETURN OF DEVICE TO PERFORM EVALUATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRAST SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT ON CARDIAC BYPASS FOR ABOUT 2 1/2 HRS WHEN BLOOD FLOW DECREASED TO A MAX OF 2 L/M THROUGH OXYGENATOR.
AMBULANCE PERSONNEL WERE ATTEMPTING TO ROUTINELY MONITOR THE PT'S ECG DURING TRANSPORT. ALLEGEDLY THE UNIT INTERMITTENTLY DISPLAYED A FLATLINE AND A 'CONNECT LEADS' MESSAGE. THE PT WAS SUCCESSFULLY TRANSPORTED TO THE HOSP WITH NO ADVERSE EFFECTS AS A RESULT OF THE ALLEGED MALFUNCTION.
REPORTEDLY DURING A CALL PRIOR TO THE REPORTED EVENT, THE CUSTOMER STATED THE UNIT HAD GOTTEN VERY WET DURING A RAINSTORM. AN INTERNAL INSPECTION OF THE DEVICE BY CO REVEALED NO INDICATION OF MOISTURE OR WATER DAMAGE AND PROPER OPERATION WAS OBSERVED. THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. A RECOMMENDATION WAS MADE TO THE CUSTOMER TO KEEP THE MONITORING CABLE PLUGGED INTO THE MONITOR, WHEN BEING USED IN THE RAIN, IN AN ATTEMPT TO KEEP MOISTURE OUT OF THE CONNECTOR.
THE DEVICE WAS APPLIED DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE. THE SAFETY SHIELD DID NOT RETRACT WHEN APPLIED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
IT IS REPORTED TO CO THAT WHILE BEING SUPPORTED BY AN LVAD, THE PT DEVELOPED SYMPTOMS OF A LEAK IN THE SYSTEM. THE PT WAS TAKEN TO THE OR AND RE-IMPLANTED WITH A SIMILAR DEVICE.
FATHER STATED THAT HIS SON FELL TO THE FLOOR WHILE ENTERING THROUGH THE SCHOOL'S RAMP. HURT HIS ELBOW CAUSING A BIG EDEMA. THE CAUSE OF HIS FALL WAS THAT THE METAL OF THE BACKFRAME BROKE WHICH UNBALANCED HIS BODY.
WAITING FOR RETURN OF DEVICE TO PERFORM EVALUATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
LEAKING WHERE RE-INFUSING, HAD NOT RE-INFUSED YET.
REMOTE BOX S L DEALER ALLEGES THAT CHAIR TAKES OFF ON ITS OWN.
EVAL OF DEVICE PENDING. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE ANESTHESIA BREATHING CIRCUIT WAS DISCOVERED TO CONTAIN PIN HOLES IN ITS CORRUGATED HOSE WHICH WOULD CAUSE IT TO LEAK.
LEAK TESTS WERE PERFORMED ON TWO RETURNED BREATHING CIRCUITS. ONE CIRCUIT WAS CONFIRMED TO LEAK, BUT AT A RATE LOWER THAN WHAT WOULD HAVE CAUSED CO TO CONSIDER IT REPORTABLE. SINCE CO ALSO DETERMINED THAT IT WAS FROM THE SAME VINTAGE OF CORRUGATED HOSE THAT HAS BEEN IDENTIFIED AS POSSIBLY CONTAINING PIN HOLES THAT COULD POSSIBLY CAUSE A CIRCUIT TO LEAK IN EXCESS OF OUR CRITERIA, CO HAS DETERMINED THIS INCIDENT TO BE REPORTABLE. THE DEFECT IS NOT CONSIDERED TO REPRESENT A SIGNIFICANT HEALTH HAZARD BUT COULD CAUSE A MINOR DELAY IN INITIATING AN ANETHETIC PROCEDURE. CO HAS INITIATED A RECALL AFFECTING A LIMITED VINTAGE OF ADULT BREATHING CIRCUITS IDENTIFIED AS CONTAINING THE SUSPECT CORRUGATED HOSE IN QUESTION.
STAFF NURSE WAS DOING ROUTINE CHECK ON DEFIBRILLATOR AND WAS SHOCKED. THERE WAS NO LIQUID ON THE RN'S HANDS OR FLOOR TO CONDUCT THE CHARGE. RN USED STANDARD PROCEDURE SHE HAS USED SINCE ORIGINALLY IN-SERVICED ON THE USE OF THE DEFIBRILLATOR.
WHEN HUNG UPSIDE DOWN BLOOD LEAKED FROM THE SUCTION PORT.
X-TUBE ASSEMBLY 16"X18". DEALER CLAIMS X-TUBE BROKE AT CENTER BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ON 9/24/96, THE PT HAD A LEAD AND GENERATOR REPLACEMENT. ON 9/25/96, THE PT WAS RETURNED TO THE OR EMERGENTLY FOR A NEW LEAD AND BIPOLAR GENERATOR.
WHEN UNIT IS USED TO RE-INFUSE CONNECTOR IS FALLING OFF AND BLOOD SPILLS OUT.
DURING ROUTINE TESTING, THE DEVICE WAS OBSERVED TO CHARGE PROPERLY BUT INTERMITTENTLY DISCHARGED WHEN THE DISCHARGE BUTTONS WERE PRESSED.
IN AN EVAL OF THE DEVICE, THE HOSP BIOMEDICAL DISCHARGED ENERGY. FURTHER EVAL OBSERVED AN INTERMITTENT CONNECTION TO THE STERNUM PADDLE DISCHARGE BUTTON. THE CONNECTION WAS REPAIRED AND THE DEVICE RETURNED TO USE.
DURING A LAPAROSCOPIC SURGERY, THE SURGEON HAD DIFFICULTY REMOVING THE TROCAR FROM THE CANNULA. AS THE SURGEON WAS ABLE TO REMOVE THE TROCAR, THE VALVE INVERTED RESULTING IN CO2 LEAKAGE. THERE WAS NO REPORTED HARM TO THE PT. THE SPECIMEN WAS NOT RETURNED TO THE MFR.
X-TUBE ASSEMBLY 16"X 16". DEALER CLAIMS X-TUBE BROKE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OF OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
FILTER WAS CLOGGING, AIR VENT ON UNIT RUPTURED, SPRAYING NURSES WITH BLOOD DURING INFUSION.
TWO LEADS WERE REMOVED FROM SVC. THE FORM STATED "FRACTURED LEADS IN POCKET", ADD'L INFO STATED THE LEADS APPEARED TO HAVE "INSULATION RUB ABRASION." THE LEADS WERE REPLACED WITH A NEW RATE SENSING LED.
THE CUSTOMER REPORTED THE UNIT WOULD NOT PASS EXTENDED SELF TEST (EST) AND ALSO ALLEGED THE EXHALATION FILTER HEATER ASSEMBLY WOULD NOT HEAT. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE UNIT WOULD NOT PASS EST. THE CUSTOMER HAD REPORTEDLY DISCARDED THE FILTER HEATER ASSEMBLY PRIOR TO THE CSE'S VISIT WHICH HAD INSTALLED A REPLACEMENT HEATER IN THE UNIT AND VERIFIED THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE FILTER HEATER MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE TUBE CAME OUT OF COLLECTION CONTAINER WHERE THE REFLUX VALVE IS LOCATED.
THE CHILD REPORTED NO LONGER HEARING ON SEVERAL ELECTRODES. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT , IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MFR'S SPECS. EXPLANTATION/REIMPLANTATION SURGERY HAS NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT.
NO MEDWATCH FORM WAS REC'D BY THE MFR. THE PT REPORTED NO LONGER HEARING ON SEVERAL ELECTRODES. (PT CODE 1882). DIAGNOSTIC TESTING INDICATED THAT THE DEVICE DID NOT FUNCTION WITHIN MFR'S SPECS (DEVICE CODE 1199).
DOCTOR'S OFFICE STATED CHILD ACCIDENTLY SPRAYED PRODUCT IN HER EYES.  DOCTOR'S OFFICE CONTACTED A CHEMICAL EMERGENCY REPONSE CENTER FOR ADVISE ON CHEMICAL AND FIRST AID. CENTER ADVISED CALLER TO WASH EYE FOR 15 MIN BY THE CLOCK. ALSO ADVISED TO TAKE VICTIM TO A DOCTOR (EYE) FOR FURTHER CARE.
APPROPRIATE STATEMENT IS ON LABEL. THIS ADDRESSES SKIN/EYE CONTACT WITH CHEMICAL.
DURING AN UNSPECIFIED THYROID PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEUDRE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
A PROXIMAL CURCUMFLEX ARTERY WAS TREATED WITH A BURR FOR APPROX TWO MINS OF ABLATION TIME. WHILE THE GUIDE WIRE WAS BEING REMOVED AFTER TREATMENT, THE WIRE BECAME DIFFICULT TO REMOVE. THE GUIDE WIRE SPRING TIP UNRAVELED AND FRACTURED. THE DISTAL PORTION OF THE GUIDE WIRE RETRIEVED.
ELEVATED POTASSIUM VALUES WERE OBTAINED ON TWO PT SAMPLES WHICH WHEN REPEATED GAVE NORMAL VALUES. NORMAL VALUES WERE CONFIRMED ON ANOTHER ANALYZER. THE PROBLEM WAS TRACED TO A FLOW PROBLEM RELATED TO THE PINCH VALVE ASSEMBLY. NO ACTION WITH RESPECT TO PT TREATMENT WAS TAKEN BASED ON THESE RESULTS.
A FIELD SERVICE ENGINEER VISITED THE ACCOUNT TO TROUBLESHOOT THE PROBLEM. THE PROBLEM WAS TRACED TO A CHECK VALVE IN THE SYSTEM. THE VALVE WAS REPLACED AND MINOR ADJUSTMENTS WERE MADE. THESE ACTIONS CORRECTED THE PROBLEM.
OR AXLE MAG W/NUT. DEALER CLAIMS AXLE BLEW APART. BALL BEARINGS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL.  THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE PT TOUCH SENSOR OF THE LEHR COLLIMATOR USED ON HEAD 2 WOULD NOT DE-ACTIVATE GANTRY MOTION WHEN ACTIVATED.
ISOLATED PROBLEM TO OPEN ON BACKPLANE FOR RADIUS AND ROTATE COLLIMATOR USED ON HEAD2. REPAIRED AND DERIFIED PROPER OPERATION.
DEALER CLAIMS THE BALL BEARING FELL OUT, WHEEL FELL OFF.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OF OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING AN UNSPECIFIED THYROID PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
REPORT RECEIVED VIA CUSTOMER RETURN OF A MODEL 726A/+23.0 (D) INTRAOCULAR LENS IN THAT THE HAPTIC BENT DURING INSERTION INTO THE PT'S RIGHT EYE. ACCORDING TO THE PHYSICIAN'S OPERATIVE REPORT, HE BEGAN TO INTRODUCE THE ONE PIECE PMMA LENS AND IT COULD BE SEEN THAT THE WOUND WAS SLIGHTLY TOO SMALL TO ALLOW PASSAGE. DURING ATTEMPTED INSERTION, THE INFERIOR HAPTIC BENT. SUBSEQUENTLY, AN IDENTICAL 23.00 (D), MODEL 726A LENS WAS IMPLANTED WITHOUT DIFFICULTY AFTER HAVING WIDENED THE WOUND. INJECTIONS OF KEFZOL (SUPERIORLY) AND CELESTONE (INFERIORLY) WERE GIVEN. MAXITROL OINTMENT WAS PLACED IN THE EYE AND THE EYE WAS COVERED WITH A PROTECTIVE SHIELD. THE PT WAS SENT HOME IN GOOD CONTITION. NO FURTHER INFO IS EXPECTED.
DEVICE EVALUATION NOT DONE ON THE REMOVED LENS AS IT WAS THE PHYSICIAN WHO BENT THE HAPTIC DURING INSERTION. WOUND WAS NOT MADE LARGE ENOUGH TO PASS THE LENS.
THE PT RECEIVED AN ASCITES SHUNT IN 9/93. IT WAS REMOVED ON 9/18/96 BECAUSE IT WAS NON-FUNCTIONING. DURING REMOVAL, THE SURGEON NOTED THAT THE PERITONEAL CATHETER HAD SEVERED FROM THE SHUNT AND WAS PRESUMED TO BE IN THE PERITONEAL CAVITY. THE SEVERED CATHETER WAS MOST LIKELY THE REASON WHY THE SHUNT WAS NON-FUNCTIONING. THERE WERE NO ADVERSE OCCURRENCES NOTED TO THE PT, AND A NEW SHUNT WAS PLACED.
MICROSCOPIC EXAM OF PRODUCT SHOWED THAT THE PERITONEAL CATHETER WAS TORN BY A NEEDLE OR OTHER SHARP OBJECT, MOST LIKELY AT THE TIME OF IMPLANT. ONCE CUT, SILICONE RUBBER HAS VERY LOW TEAR RESISTANCE. THE INSTRUCTIONS FOR USE FOR THIS DEVICE CAUTION THE USER TO AVOID CUTTING OR PUNCTURING THE CATHETERS, AS LEAKAGE OR TEARING MAY OCCUR.
BREAKING OF ENGINE AXIS FOR THE ARM DURING GANTRY PARKING.
THE SHAFT WAS ANALYZED ON THE SURFACE AND CONCLUDED THAT THERE WERE FATIGUE TRACES.
DURING A FRAGMENTATION PROCEDURE, THE FRAGMENTATION FUNCTION ON THE FOOT SWITCH WAS STICKING. ANOTHER FOOT SWITCH WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. REPLACED A STICKING FOOT PEDAL.
TECHNOLOGIST CLAIMED HE SAID HE SAW A "FLAME" OR A "BRIGHTNESS" AND HAD A BURNING ODOR.
INVESTIGATION RESULTS: AN EVALUATION OF THE RETURN SAMPLE CONFIRMS THAT THE DEVICE NEEDED REPAIR DUE TO NORMAL "WEAR AND TEAR" OF THE UNIT AND NOT DUE TO ANY DEFECT FROM THE MFR. CORRECTIVE ACTION: BARIFLOW CAT. #800, SERIAL #GA1668 WAS REFURBISHED. THE MAIN SWITCH, FOOT SWITCH AND MOTOR WAS REPLACED TO BALANCE HAMMER.
AMBULANCE PERSONNEL WERE ATTEMPTING TO MONITOR A PT EXPERIENCING ABDOMINAL PAIN AND SHORTNESS OF BREATH. REPORTEDLY THE MONITORED DISPLAYED AN INAPPROPRIATE FLATLINE AND THE CRT FLICKERED IN AND OUT. THE REPORTED STATED THERE WERE NO ADVERSE EFFECTS TO THE PT AS A RESULT OF THE ALLEGED MALFUNCTION.
H6. CO EXAMINED THE DEVICE AND OBSERVED PROPER OPERATION DURING THE NORMAL TESTING PROCEDURE. IT WAS OBSERVED THAT WHEN THE EXTERIOR CASE OVER THE CRT ASSEMBLY WAS PHYSICALLY PRESSED DOWN AND THE CRT MOMENTARILY DISPLAYED A FLAT LINE, HOWEVER, THIS ANOMALY WAS NOT DUPLICATED DURING THE REMAINDER OF THE TEST. AN INTERNAL INSPECTION WAS PERFORMED AND IT WAS OBSERVED THE CRT WOULD INTERMITTENTLY SHRINK HORIZONTALLY WHEN COMPONENT C102 ON THE SYSTEM PRINTED CIRCUIT BOARD WAS PHUSICALLY MANIPULATED. THE SYSTEM PRINTED CIRCUIT BOARD WILL BE REPLACED AND THE DEVICE RETURNED TO THE CUSTOMER FOR USE.
SUBSEQUENT TO THE FIXATOR BEING APPLIED IT WAS NOTED THAT ONE OF THE CLAMPS HAD BROKEN. THE FIXATOR WAS REMOVED AND A NEW FIXATOR APPLIED. THERE WAS NO INJURY TO THE PT.
RETURNED TO SURGERY TO REMOVE PORTION OF DRAIN FROM LEFT MASTECTOMY AREA. DRAIN EVIDENTLY BROKE WHEN SURGEON WAS ATTMPTING TO REMOVE IT.
X-TUBE ASSEMBLY 18"X 18". DEALER CLAIMS X-TUBE BROKE AT REAR CROSS TUBE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PRT 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
APPROX. ONE WEEK AFTER DEVICE WAS APPLIED FOR A DISTAL RADIUS FRACTURE, DURING A PREVIOUSLY PLANNED SURGERY, IT WAS NOTED THAT THE BALL JOINT HAD LOOSENED. MD RETIGHTENED THE BALL JOINT. THERE WAS NO INJURY TO THE PT.
PT UNDERWENT A RADICAL MASTECTOMY PROCEDURE. THE DRAIN REMAINED IN THE WOUND UNTIL DRAINAGE CONSISTED OF 30CC OF FLUID AROUND EIGHT DAYS AFTER SURGERY. UPON REMOVAL BY PHYSICIAN, THE DRAIN FRACTURED LEAVING A PORTION IN THE WOUND SITE. PT WAS ADMITTED TO THE HOSP AND WAS TAKEN TO SURGERY FOR THE REMOVAL OF THE REMAINDER PORTION OF THE DRAIN. PT STATED THAT HE HAS THE SAMPLE PORTION OF THE DRAIN IN HIS POSSESSION.
PAST HISTORY OF COMPLAINTS OF THIS TYPE HAVE BEEN DUE TO NICKING, SUTURING AND TISSUE INGROWTH.
THE PT WAS ON THE BED WHEN THE LIGHT FELL. THE LIGHT WAS CAUGHT PRIOR TO HITTING THE PT.
THERE WAS NO INJURY DURING THIS EVENT SO PT CODES ARE NOT APPLICABLE.
CNTL INTGRI PG8/50 W/ARM L P1. DEALER ALLEGES CHAIR RUNS ON ITS OWN, IT WILL SHOOT OFF TO THE RIGHT WITH NO WARNING.
NO FAULT COULD BE FOUND. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC., OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING AN UNSPECIFIED PROCEDURE THYROID PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE FOOTREST DETACHED WHILE THE PT WAS SITTING ON IT. APPARENTLY THE PT FELL ON THE FLOOR CAUSING DERMAL TRAUMA TO THE SACRAL AREA. INSEPCTION OF THE FOOTREST DID NOT SHOW ANY FAILURE OF THE LATCHING MECHANISM.
THE GANTRY ROTATED UNEXPECTEDLY AND STRUCK THE UNDERSIDE OF THE PT TABLE. A PT WAS ON THE TABLE BUT WAS NOT INJURED. INVESTIGATION INDICATED THAT GANTRY ROTATION WAS DUE TO A SHORT BETWEEN TWO WIRES IN THE GANTRY HAND-HELD CONTROL BOX (CONTROL).
DURING A PLANNED MAINTENANCE VISIT, SVC REP NOTED OUTPUT OF VAPORIZER WAS NOT WITHIN SPEC. THERE WAS NO REPORTED PT INJURY. CO'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
INVESTIGATION/CONCLUSION: THE UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED, THE CAUSE OF WHICH WAS THE ROTARY VALVE. OHMEDA HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE TEC 6 VAPORIZER. AS A RESULT, THE FREQUENCY OF OCCURRENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED U.S. BASE IN FISCAL YEAR 1996 FROM 0.4% IN 1994. OHMEDA WILL CONTINUE TO MONITOR THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER MATERIAL AND/OR PROCESS MODIFICATIONS.
DRAIN BROKE IN HALF AS IT WAS BEING REMOVED FROM THE PT'S ABDOMEN. S/P EXPLORATION OF COMMON BILE DUCT, LYSIS OF ADHESIONS, CHOLEDOCHOLITHOTOMY T-TUBE CHOLCYSTOGRAM ON 8/19/96. PT WAS RETURNED TO OR 8/29/96 FOR EXPLORATION AND REMOVAL OF RETAINER DRAIN.
ON 8/21/96, DRAINS WERE BEING REMOVED FOLLOWING A MODIFIED RIGHT RADICAL MASTECTOMY (FOR END STAGE CARCINOMA). THE SURGEON HAD A PROBLEM REMOVING THE DRAIN WITHIN THE RECTUS SHEATH. "IT WAS QUITE TIGHT AND SEPARATED JUST BEYOND THE HUB OF THE DRAIN ITSELF". THE SURGEON'S DOCUMENTATION STATES: " I EXPLAINED THIS TO HER AND DISCUSSED THIS WITH HER AND EXPLAINED THE NATURE OF THE SUBSTANCE. SHE ASKED THAT IF IT WAS NOT ABSOLUTELY NECESSARY SHE WOULD PREFER NOT TO UNDERGO REMOVAL OF THE DRAIN AS IT WOULD LIKELY BE ENCASED IN SCAR TISSUE IN THE FUTURE. I EXPLAINED TO HER THAT IF IT BECAME INFECTED OR CAUSED DISCOMFORT THEN I WOULD RECOMMEND REMOVAL. THE RISK OF MIGRATION OF THIS DEVICE IS VERY SMALL AND ALSO EXPLAINED THAT IT IS GENERALLY RECOMMENDED THAT WE REMOVE THIS BUT SINCE SHE HAS DECLINED THEN WE WILL SIMPLY KEEP AN EYE ON THIS FOR THE FUTURE OTHERWISE HER UMBILICUS AND OTHER AREAS ARE HEALING VERY NICELY". THIS DRAIN WAS SUTURED IN PLACE IN THE RECTUS SHEATH, WHEN PLACED ON 8/12/96.
DATE SENT TO FDA: 10/11/96. INVESTIGATION SUMMARY: NO SAMPLE WAS SUBMITTED, HOWEVER, THE NARRATIVE INDICATED THAT THE DRAIN WAS SUTURED IN PLACE. THE PRODUCT INSERT CLEARLY STATES THAT THE DRAIN SHOULD NOT BE SUTURED IN PLACE. "DO NOT SUTURE THROUGH OR CUT INTO THE DRAIN AS THIS MAY RESULT IN DRAIN BREAKAGE AND/OR FRAGMENT RETENTION WITHIN THE WOUND".  ADDITIONALLY, PRECAUTIONS INCLUDED IN THE PRODUCT INSERT STATE: "THE SILICONE ELASTOMER SUCTION DRAIN TUBING IS SOFT AND PLIABLE. IT SHOULD NOT BE HANDLED WITH POINTED, TOOTHED, SHARP-CORNERED OR EVEN BLUNT INSTRUMENTS, AS PUNCTURES, SURFACE CUTS, NICKS, CRUSHING OR OTHER OVERSTRESSING CAN LEAD TO TEARING OR WARPING OF THE TUBING AND TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN AND/OR FRAGMENT RETENTION WITHIN THE WOUND." DATA ANALYSIS INDICATES THAT COMPLAINTS OF THIS TYPE ARE NOT SIGNIFICANT RELATIVE TO THE VOLUME OF DRAINS SOLD, HOWEVER, TRENDS WILL CONTINUE TO BE MONITORED. NO FURTHER INVESTIGATION WILL BE CONDUCTED UNLESS WARRENTED BY AN UNEXPECTED AND SIGNIFICANT INCREASE IN COMPLAINTS.
THE VENTILATOR SHUT DOWN WHILE COMPLETING AN INSERVICE. THE DELTA P WENT TO 0 CMH2O AND THE "OSC. STOPPED" LED CAME ON. THERE WAS NO PT INVOLVEMENT AT ALL.
DEVICE PMA # P890057. IS FREQUENCY ADDRESSED IN LABELING? NO. IF "NO" FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "YES" SEVERITY GREATER THAN LABELED? IF "NO" SEVERITY GREATER THAN USUAL? UNK. THE CO'S SVC MANAGER DISPATCHED A FIELD SVC REP TO THE HOSP. THE SVC REP TESTED THE UNIT PER ALL FACTORY SPECS AND IT PASSED. HE ALSO INSPECTED THE ELECTRONICS FOR LOOSE CONNECTIONS AND FOUND NONE. HE RAN THE UNIT FOR 2 HOURS WITHOUT A PROBLEM. THE PROBLEM COULD NOT BE DUPLICATED. THE ANALYSIS IS COMPLETE AND THE CUSTOMER HAS ALREADY BEEN NOTIFIED.  CUSTOMER WILL MONITOR UNIT/MEETS FACTORY SPECS.
IF THE USER ENTERS AN IMPROPER KEYBOARD SEQUENCE INTO THE RADIO-THERAPY PLANNING SYSTEM WHEN SWITCHING FROM ONE TREATMENT DEVICE TO ANOTHER, THE RESULTING TREATMENT PLAN COULD RESULT IN ERROR. THERE HAVE BEEN NO REPORTS OF IMPROPER THERAPY TREATMENTS DUE TO THIS USER ERROR. INSTRUCTIONS FOR PROPER USE ARE GIVEN IN THE USER MANUAL.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING AN UNSPECIFIED THYROID PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUR\URE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DRAIN FRACTURED IN HALF AS IT WAS BEING REMOVED FROM THE PT'S ABDOMEN. EXPLORATION OF COMMON BILE DUCT, LYSIS OF ADHESIONS, CHOLEDOCHELITHOTOMY T-TUBE CHOLE W/STOGRAMON 8/19/96. PT WAS RETURNED TO THE OR ON 8/29/96 FOR EXPLORATION AND REMOVAL OF RETAINED DRAIN.
ON 9/19/96 RISK MGR STATED THAT THE DRAIN WAS DISCARDED BY THE OR STAFF. PAST HISTORY OF COMPLAINTS OF THIS TYPE HAVE BEEN DUE TO NICKING, SUTURING AND TISSUE INGROWTH OF THE CATHETER.
DURING AN UNSPECIFIED THYROID PROCEDURE, THE SUTURE BROKE. APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
AT END OF PROCEDURE, AN ATTEMPT WAS MADE TO DEFLATE CUFF. PILOT BALLOON APPEARED DEFLATED. THE TUBE WAS REMOVED. IT WAS THEN DISCOVERED THAT THE CUFF WAS NOT FULLY DEFLATED. THERE WAS NO TRAUMA TO PT.
AN EVAL IS STILL IN PROGRESS. ADDITIONAL INFO WILL BE FORWARDED AS SOON AS IT BECOMES AVAILABLE.
THE PENCIL MALFUNCTIONED DURING SURGERY A FEW WEEKS AGO". THE CUSTOMER WAS CONTACTED AND INDICATED THAT THE SURGEON STATED "THE PENCIL IS NOT WORKING". NO INJURY TO PT / PERSONNEL.
THE RETURNED PENCIL WAS FOUND TO HAVE A HIGH VOLTAGE BREAKDOWN FAILURE AT THE ELECTRODE. THE ELECTRODE HAD A SMALL CRACK IN THE INSULATION SLEEVE; HOWEVER ABRASIONS ON THE METAL BLADE, ALONG WITH THE INSULATION COLLAR APPEARING FLATTENED IS INDICATIVE OF THE ELECTRODE HAVING SUSTAINED DAMAGE AS A DIRECT RESULT OF EXCESSIVE FORCE WHILE CLEANING WITH AN ABRASIVE PAD. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY . CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18 USC 1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC, OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, IT CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
VINAL ANALYSIS REVEALED DRIVENUT RUSTED IN THE DISENGAGED POSITION. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. SERIAL NUMBER PRE-DATES DRIVENUT MATERIAL CHANGE.
THE DEVICE IS STILL IN THE PROCESS OF BEING EVALUATED. ADD'L INFO WILL BE FORWARDED AS SOON AS IT BECOMES AVAILABLE.
SYSTEM BEGAN ALARMING AND FRANK BLOOD WAS NOTED IN THE CONNECTING TUBING FROM THE BALLOON TO THE PUMP. PT BECAME UNSTABLE WITH ECG CHANGES. IABP WAS REMOVED WITH NEW BALLOON INSERTED. PT'S CONDITION IMPROVED, AND REMAINED STABLE.
X-TUBE ASSEMBLY 15" X 15". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC, OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INSULATION ON TWO ELECTRODE EXTENSIONS "IS BURSTED" WHICH CAUSED A BURN TO THE PT. THE CUSTOMER INDICATED THE "BURSTING" OCCURRED DURING STERILIZATION AT A TEMPERATURE SETTING OF 134C.
THE INSULATION ON THE RETURNED ELECTRODES WAS DAMAGED AND DID NOT PASS HIGH VOLTAGE WITHSTAND TESTING. THE CUSTOMER WAS STERILIZING THE PRODUCT AT 134C. INSTRUCTIONS SENT WITH THE PRODUCT INDICATE NOT TO EXCEED 121C. ADDITIONALLY, INSTRUCTIONS STATE TO INSPECT THE INSULATION FREQUENTLY (BEFORE AND AFTER USE) FOR CRACKS, NICKS, CUTS, DENTS OR DEPRESSIONS WHICH MAY DECREASE THE INSULATION EFFECTIVENESS & MAY RESULT IN BURNS TO THE SURGEON OR PT. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18 USC 1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
THE BALLOON BURST SHORTLY AFTER INSERTION. THERE WERE NO PT COMPLICATIONS.
THE SAMPLE WAS RETURNED FOR EVAL. THE BALLOON HAD A LONGITUDINAL TEAR IN THE CTR. FAILURES OF THIS TYPE HAVE BEEN FOUND TO BE A RESULT OF WEAKNESS IN THE LATEX BALLOON FILM THAT CAN BE CAUSED BY EXTERNAL FACTORS SUCH AS IMPROPER STORAGE CONDITIONS, (HEAT, LIGHT, HUMIDITY), OR BY OVER INFLATION OF THE BALLOON.
UPON THE REMOVAL OF AN EPIDURAL CATHETER, THE TIP WAS FOUND TO BE MISSING. THE CATHETER WAS INSERTED WITH NEEDLE. THE PHYSICIAN DID NOT WITHDRAW THE CATHETER THROUGH THE NEEDLE AND DID NOT FEEL ANY UNDUE RESISTANCE DURING THIS PROCESS. THE PT WAS DISCHARGED WITH A FOLLOW-UP CLINIC APPOINTMENT FOR FURTHER EVAL.
AN EVAL IS STILL IN PROGRESS. ADD'L INFO WILL BE FORWARDED AS SOON AS IT BECOMES AVAILABLE.
THE BALLOON BURST DURING USE OF THE PRODUCT. THERE WERE NO COMPLICATIONS.
THE SAMPLE WAS RETURNED FOR EVAL. THE BALLOON HAD A TEAR IN THE LATEX NEAR THE PROXIMAL BAND. FAILURES OF THIS TYPE HAVE BEEN FOUND TO BE A RESULT OF WEAKNESS IN THE LATEX BALLOON FILM THAT CAN BE CAUSED BY EXTERNAL FACTORS SUCH AS IMPROPER STORAGE CONDITIONS, (HEAT, LIGHT, HUMIDITY), OR BY OVER INFLATION OF THE BALLOON.
REQUEST DEVICE TO BE RETURNED TO MFR FOR EVAL.
WHEN TESTED, THE VALVE SHOWED A HYDROSTATIC PRESSURE OF AS HIGH AS 190 MM.
THE RETURNED PRODUCT WAS EVALUATED BY MEDTRONIC PS MEDICAL FOR PATENCY, PRESSURE/ FLOW CHARACTERISTICS AND PREIMPLANTATION PRESSURE. THE PRODUCT MET MEDTRONIC PS MEDICAL SPECIFICATIONS FOR PATENCY, BUT TEST RESULTS WERE 0.5 CM BELOW SPECIFICATIONS FOR PRESSURE/FLOW. A SITUATION WHERE THE VALVE PRESSURE WAS "TOO HIGH" AS REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED, NOR COULD A CAUSE OF SUCH PERFORMANCE BE DETERMINED.
WHEN THE VALVE WAS HOOKED TO THE MANOMETER THE MANOMETER PRESSURE DID NOT DROP AS EXPECTED.
THE RETURNED PRODUCT WAS EVALUATED BY CO FOR PREIMPLANTATION PRESSURE, PRESSURE/FLOW CHARACTERISTICS, PATENCY AND SIPHONING. PARTICLES WERE FOUND IN THE SIPHON CONTROL AREA OF THE VALVE. WHEN TESTED, THE PARTICLES FLUSHED OUT DURING INITIAL PRIMING AND HAD NO EFFECT ON THE PERFORMANCE OF THE VALVE. THE PRODUCT MET ALL CO'S PERFORMANCE SPECIFICATIONS. THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED AND NO ANOMALIES WERE NOTED.
IABP ALARMED, AND BLOOD WAS IN THE AIR/HELIUM CHAMBER. CLOT NOTED INSIDE THE BALLOON. BALLOON WAS DC'D. NO COMPLICATION THAT CAN BE DIRECTLY ATTRIBUTED TO EVENT.
IABP ALARMED "BLOOD DETECTED IN CATHETER" BALLOON DC'D AND NEW BALLOON INSERTED. NO ADVERSE OUTCOME RELATED TO THE EVENT.
IABP INSERTED 7/29/95. ALARM NOTED "BLOOD IN TUBING" AND WOULD NOT PUMP. SCANT AMT OF BLOOD WAS SEEN IN THE TUBING. BALLOON AND PUMP CHANGED. NO ADVERSE OUTCOME RELATED TO THE EVENT.
BLOOD NOTED IN TUBING BY STAFF. PUMP SHUT OFF. BALLOON REMOVED, NO ADVERSE PT OUTCOME.
PT FELL INJURING SIDE, POTENTIAL BROKEN RIBS. PT HOSPITALIZED SUBSEQUENTLY PASSED AWAY. IT IS BELIEVED PULMONARY EMBOLISM WAS THE CAUSE.
BALLOON INSERTED 12/1/95 ALARMED. NO BLOOD NOTED IN TUBING. PUMP CHANGED WITH SAME ALARM NOTED. MD REMOVED IABP, UPON PULLING CATH BACK BLOOD FILLED THE BALLOON. NO ADVERSE PT OUTCOME.
THE DEVICE WAS REMOVED DUE TO A "TUBING FRACTURE ON LEFT SIDE OF THE PUMP CONNECTION". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED.
EVAL IS PENDING DECONTAMINATION, EXAM AND TESTING OF THE RETURNED DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION.
THE DEVICE WAS REMOVED DUE TO "SIGNIFICANT AUTOINFLATION AND A CLINICALLY DEFECTIVE PUMP". AS REPORTED TO CO THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
EVAL IS PENDING DECONTAMINATION, EXAM AND TESTING OF THE RETURNED DEVICE COMPONENT. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELLING OR USUAL FOR SERVICE. AND EVAL WILL BE FORWARDED UPON COMPLETION.
A PT WHO PREVIOUSLY HAD A PROSTATECTOMY WAS TESTED ON 8/13/96 USING THE PSA-E ASSAY. THE DATE OF THE PROSTATECTOMY WAS UNKNOWN, HOWEVER, THE REPORTING INDIVIDUAL INDICATED THAT THE TUMOR WAS LOW STAGE WITH NO EVIDENCE OF CAPSULARY INVASION. THE RESULT OF THE PSA-E TEST WAS 0.8 NG/ML. THE UROLOGIST QUESTIONED THESE RESULTS AND ANOTHER SPECIMEN WAS DRAWN AND TESTED ON 8/20/96. THE RESULT OF THE PSA-E TEST WAS 0.9 NG/ML. A DIFFERENT SAMPLE FROM THE PT WAS SENT TO ANOTHER FACILITY FOR TESTING USING THE PSA-R ASSAY. THE RESULT OF THE PSA-R TEST WAS <0.1 NG/ML. ONE WEEK LATER, ANOTHER SPECIMEN WAS DRAWN. THIS SPECIMEN WAS SPLIT AND TESTED BY THE REPORTING LAB USING PSA-E AND BY ANOTHER FACILITY USING PSA-R. THE PSA-E RESULT WAS 0.3 NG/ML AND THE PSA-R RESULT WAS 0.1 NG/ML. NO TREATMENT WAS INITIATED ON THE PT DUE TO THE FIRST TWO ELEVATED PSA-E RESULTS AS THE UROLOGIST WAS SUSPICIOUS OF THESE RESULTS. THE LOT NUMBER OF ALL KIT LOTS USED FOR TESTING WAS NOT KNOWN BY THE REPORTING INDIVIDUAL.
THE SUBMISSION OF THIS MEDICAL DEVICE REPORT IS REQUIRED OF DEVICE MFRS BY 21 CFR PART 803. NEITHER THE SUBMISSION OF INFO BY CO PURSUANT TO THIS RULE, NOR THE PUBLIC RELEASE OF SUCH INFO, CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CONNECTIONS BETWEEN THE PRODUCT AND ANY DEATH OR INJURY. NOTE THAT THERE WAS NO METHOD OR RESULTS CODES NOTED AS THE DEVICE LOT NUMBER WAS UNK BY THE REPORTING INDIVIDUAL. NO TESTING WAS PERFORMED AT CO AS THE KIT LOT NUMBER WAS NOT KNOWN. NO SAMPLE WAS RETURNED FROM THE CUSTOMERS.
REPORTER STATED THAT EXCESSIVE VACUUM IN I/A CAUSED TEAR IN ANTERIOR CAPSULE. NO VITREOUS LOSS. NO PERMANENT INJURY AND NO INTERVENTION REPORTED.
A CO SVC REP CHECKED THE SYSTEM AND COULD NOT FIND A PROBLEM WITH THE VACUUM. THE SYSTEM HAD NOT BEEN SERVICED BY ALCON SINCE 2/18/94. PT INFO  HAS BEEN REQUESTED BUT NOT REC'D TO DATE. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED AN ADMISSION THAT CO'S PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE DEVICE WAS REMOVED DUE TO "FLUID LOSS". ADD'L SER NO: 012243.
ACCORDING TO AVAILABLE INFO THIS PENILE PROSTHESIS WAS IMPLANTED ON 3/27/87. ON 10/18/96 DEVICE WAS EXPLANTED, REPORTEDLY DUE TO A FLUID LOSS. SPECIFICALLY, A DEVICE TRACKING FORM INDICATED THAT DEVICE WAS "LEAKING [AT THE] L[EFT] CYLINDER. "TWO CYLINDERS WITH ATTACHED CONNECTORS, AND PUMP WITH ONE ATTACHED CONNECTOR WAS RECEIVED AND EVALUATED BY MFR. DURING FUNCTIONAL TESTING A LEAK WAS OBSERVED NEAR STRAIN RELIEF OF ONE OF CYLINDERS. MICROSCOPIC EXAMINATION OF LEAKAGE SITE WAS PERFORMED. CYLINDER'S TUBING WAS SEPARATED IN TWO PLACES. CROSS SECTIONAL SURFACES OF SEPARATION SITES WERE ROUGH AND IRRIGULAR, INDICATING A TUBING TEAR. BASED ON RECEIVED INFOA AND QUALITY ASSURANCES'S EVAL, QA CONCLUDES THAT A TUBING TEAR IN ONE OF CYLINDERS CAUSED REPORTED FLUID LOSS. THUS, QA CONFIRMS REPORTED FLUID LOSS. TUBING TEAR WAS CAUSED BY STRESSES EXPERIENCED BY DEVICE WHILE IN-VIVO.
HOSP REPORTS NEEDLE TIP "BROKE" WHILE IN USE. NO PT INJURY WAS EXPERIENCED.
THE RETURNED PRODUCT WAS EVALUATED AND THE GLUE BOND CONNECTING THE CANNULA TO THE HUB, FAILED. NUMBER OF PERSONS AFFECTED=1. DISCLAIMER. THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE DEVICE WAS REMOVED DUE TO "BROKEN TUBING". AS REPORTED TO THE MFR, THE CYLINDER AND PUMP COMPONENT ONLY WERE REMOVED AND REPLACED; LEAVING THE INITIAL IMPLANTED RESERVOIR COMPONENT IN PLACE. 10/24/96-UPON RECEIPT OF INFO PROVIDED TO CO BY THE PHYSICIAN/SURGEON'S OFFICE IT WAS STATED... "PARTIAL TEARS, ONE IN EACH CYLINDER TUBE". ADDITIONALLY , THE PHYSICIAN REPORTED... "PT FREQUENTLY PUMPED UP THE CYLINDERS AS MUCH AS HE POSSIBLY COULD".
ADD'L INFO CONCERNING THIS EVENT, AND RETURN OF THE EXPLANTED PROSTHESIS WAS REQUESTED. HOWEVER, AT THIS TIME NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO RECORD OF IMPLANT HISTORY FOR THIS DEVICE HAS BEEN OBTAINED AT THIS TIME AND QA IS UNABLE TO VERIFY THE DEVICE REFERENCED WAS MANUFACTURED BY THIS CORPORATION. IN ADDITION, WITHOUT THE BENEFIT OF EXAMINATION AND TESTING OF THE DEVICE QA IS PRECLUDED FROM CONFIRMING THIS REPORT OR DETERMINING THE CAUSE. SHOULD ADD'L  INFO AND OR THE DEVICE BE RECEIVED, QA WILL FILE AND ADDENDUM TO THIS REPORT.
THE DEVICE "WOULDN'T INFLATE". IT WAS REPORTED THAT DURING THE PROCEDURE, A "KINK IN THE TUBING AND SCAR TISSUE" WAS OBSERVED. THE SURGEON "CUT AND SHORTENED THE TUBING"; ONLY CONNECTOR WAS EMPLOYED TO REPAIR THE DEVICE; NO OTHER DEVICE COMPONENT WAS REMOVED. 10/8/96-RECEIVED INFO FROM THE PHYSICIAN WHICH STATED, "EXCESSIVE TUBING CAUSING KINKING. TUBING ONLY REPLACED".
AS REPORTED TO CO BY THE CO SALES REP PRESENT AT THE SURGERY, THE CONNECTOR WHICH WERE REMOVED ON 9/25/96, WERE DESTROYED. THEREFORE, CO'S EVALUATION WILL BE BASED ON ANY INFO CO OBTAIN FROM THE PHYSICIAN/SURGEON. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION.
ON SEPTEMBER 16, 96 THE ACCOUNT OBTAINED DISCREPANT RESULTS WHEN A TEST GAVE A CLEAR NEGATIVE RESULT WITH A SERUM SAMPLE VERSUS ANOTHER PACK IN A NEW BOX OF THE SAME LOT. THE PT WAS BEING EXAMINED DUE TO ABDOMINAL PAIN AND INVESTIGATION OF A POSSIBLE ECTOPIC PREGNANCY. A SONOGRAM WAS PERFORMED AND THE PT WAS PREGNANT. WHEN THE DOCTOR QUESTIONED THE RESULT DUE TO PHYSICAL EVIDENCE, A SECOND DEVICE WAS RUN ON THE SAME LOT FROM A NEW BOX AND THE RESULT WAS POSITIVE. THE PT IS NOT ON ANY MEDICATIONS. A QUANTITATIVE TEST WAS ORDERED AND THE RESULT WAS 600. THE ACCOUNT DID NOT KNOW THE METHODOLOGY OF THE QUANTITATIVE TESTING. NO PT INFO IS AVAILABLE.
PT INFO SOURCED BY THE MFR. TESTING WAS UNABLE TO CONFIRM THE INITIAL NEGATIVE RESULT OBTAINED BY THE ACCOUNT DUE TO THE NATURE OF THE SINGLE USE DEVICE. TESTING WAS PERFORMED USING THE SAME SAMPLE BUT IN HOUSE REACTION DISCS (ACCOUNT DID NOT RETURN KIT). THE ACCCOUNT'S POSITIVE RESULT WAS CONFIRMED USING BOTH QUALITATIVE AND QUANTITATIVE TESTING.
THE DEVICE WAS REMOVED DUE TO A "TUBING FRACTURE ON THE RIGHT SIDE". AS REPORTED TO CO, THE PUMP, CYLINDER AND ASSEMBLY KIT COMPONENT ONLY WERE REMOVED AND REPLACED. THE RESERVOIR WAS LEFT IN PLACE.
EVAL AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE COMPONENT. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OF USUAL FOR SERVICE. AN EVAL WILL FORWARDED UPON COMPLETION.
QR AXLE. DEALER CLAIMS BEARINGS HAVE FALLEN OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INDO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WHILE NURSE WAS REMOVING EPIDURAL CATHETER, IT STARTED STRETCHING AND THE TIP SNAPPED OFF, REMAINING IN THE PT.
IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES: "DO NOT WITHDRAW THE CATHETER THROUGH THE NEEDLE BECAUSE OF THE POSSIBLE DANGER OF SHEARING". NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. DISCLAIMER: B BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED 12/11/95. B.BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CAUSUAL RELATIONSHIPS TO DEVICES MANUFACTURED OR DISTRIBUTED BY B BRAUN MEDICAL INC.
X-TUBE ASSEMBLY  17" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, IC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGN, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTTRIBUTED TO THE REPORTABLE EVENT.
DR COULD NOT REMOVE THE HEALING SCREW FROM THE IMPLANT. IMPLANT WAS REMOVED DUE TO MOBILITY. ONE PERSON AFFECTED.
THE RETURNED IMPLANT/COVER SCREW WERE EVALUATED. AFTER CLAMPING THE IMPLANT INTO A VICE, THE COVER SCREW WAS ABLE TO BE REMOVED. BOTH THE IMPLANT AND THE COVER SCREW MET SPECIFICATIONS. IT IS POSSIBLE THAT EXCESSIVE TORQUE WAS APPLIED WHEN SEATING THE SCREW. IT IS ALSO POSSIBLE THAT NOT ENOUGH TIME ELAPSED BETWEEN IMPLANT INSERTION AND COVER SCREW REMOVAL ATTEMPT (JUST 3 MONTHS). THREE MONTHS IS THE MINIMUM AMOUNT OF TIME RECOMMENDED(MANDIBLE), FOUR MONTHS IS THE MINIMUM (MAXILLA) FOR HEALING/INTEGRATION. ACTUAL TIMES WILL VARY WITH THE INDIVIDUAL PT HEALING RATES. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
HOSP REPORTS THAT THE BALLOON ON THE BALLOON CATHETER RUPTURED IN THE BODY THE FIRST TIME IT WAS INFLATED.
THE ENTIRE CATHETER, INCLUDING THE BALLOON, WAS REMOVED FROM THE PT. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. DISCLAIMER: B BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 MEDICAL DEVICE REPORTING DATED 12/11/95. BRAUN MEDICAL INC. DOES NOT INTENDED THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CASUAL RELATIONSHIPS TO DEVICES MANUFACTURED OR DISTRIBUTED BY B BRAUN MEDICAL INC.
IMPLANT WAS REMOVED BECAUSE OF PAIN. ONE PERSON AFFECTED.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
AN IMPLANT WASN'T INTEGRATED AT THE TIME OF RESTORATION.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE LOT NUMBER WAS UNAVAILABLE FROM THE DR.
THE DIALYSIS MACHINE TECHNICIAN REPORTED THAT ONE PT BECAME ILL AND NEEDED TO BE HOSPITALIZED. THE DOCTOR THAT TREATED THE PT BELIEVES THAT THE PT HAD HEMOLYSIS AND THAT KINKING IN THE TUBING LINES MAY HAVE BEEN THE CAUSE. THE KINKING ALLEGEDLY OCCURRED WHERE THE TUBING EXITS THE DIALYZER AND BETWEEN THE ARTERIAL DRIP CHAMBER AND THE PUMP SEGMENTS.
NO OTHER REPORTS HAVE BEEN REC'D FOR THIS REPORTED LOT NUMBER. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. DISCLAIMER: B BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED 12/11/95. BRAUN MEDICAL INC DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CAUSAL RELATIONSHIPS TO DEVICES MFG OR DISTRIBUTED BY B. BRAUN MEDICAL INC.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH COMPONENTS. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE UNAVAILABLE FROM THE DR.
REAR S/F DAB R. DEALER CLAIMS FRAME BROKE BEHIND REAR VERTICAL TUBE.
AN IMPLANT FAILED DUE TO PERIODONITIS IN THE MAXILLA.
ALL AVAILABLE INFO REGARDING THIS COMPLAINT WAS INVESTIGATED AND REVIEWED. ELECTRONIC TESTING OF THE RETURNED SENSOR WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPEC. NO PHYSICIAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPEC. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND / OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPEC.
DURING AN ANTERIOR VITRECTOMY PROCEDURE, THE VITRECTOMY CUTTER WOULD NOT FUNCTION. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. REPLACED A STICKING VITRECTOMY CONTROL VALVE.
FIFTY-SEVEN-YEAR OLD PT WITH A CVA HAD A CATHETER IMPLANTED ON 8/21/96. WHEN PHYSICIAN REMOVED THE CATHETER AND LOOKED AT IT CAREFULLY, HE NOTED THE TIP WAS MISSING. DR EXPLORED THE AREA AND WHAT HE FELT MIGHT BE TIP. THIS PHYSICIAN HAD A 15 DAY REPORTABLE DUE TO A FELT TIP THAT WAS LEFT IN A PT WHEN HE REMOVED ANOTHER CATHETER. IT WAS DISCOVERED BY RADIATION ONCOLOGIST. DR IS QUESTIONING WHETHER THIS IS A PRODUCT DEFECT AND IF THERE HAVE BEEN OTHER INCIDENTS.
X-BRACE FOR Q2. DEALER CLAIMS: BROKEN X-BRACE AT THE BOLT HOLE.
THE BIPOLAR FUNCTION OF THIS OPHTHALMIC MICROSURGICAL UNIT CUTS ON AND OFF. THE UNIT WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE.
BALLOON FAILED TO INFLATE WHEN TESTED PRIOR TO USE.
WHEN THE 60 ML SYRINGE WAS OPENED, IT WAS NOTICED THAT THE THUMB GRIP OF THE PLUNGER APPEARED DIRTY.
DURING A PHACOEMULSIFICATION PROCEDURE, THE VITRECTOMY CUTTER WOULD NOT FUNCTION AND THE PHYSICIAN BROKE THE PT'S CAPSULE. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. THIS UNIT WAS BEING USED DURING AN EVAL AND DID NOT BELONG TO THE USER. EVAL OF THE UNIT INDICATED THAT THE VITRECTOMY VALVE PLUG HAD PULLED FROM THE MOTHERBOARD.
INABILITY TO THREAD IV CATHETER BECAUSE TEFLON TIP FRAYS.
DURING AN OPHTHALMIC PROCEDURE, WHEN THE LIGHT PIPE WAS CONNECTED TO THE UNIT, THE PROXIMAL END BURNED IN THE MACHINE SOCKET. THE LIGHT PIPE WAS EXCHANGED AND THE PROXIMAL CONNECTOR WAS CLEARLY DISCOLORED AND PARTIALLY MELTED. ANOTHER LIGHT PIPE WAS ABLE TO BE USED FOR THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE OR EFFECT ON THE PT.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. THE MFG PROCESS HAS BEEN CHANGED TO PREVENT EXPOSED EPOXY ON THE END OF THE CONNECTOR ON THE LIGHT PIPE.
REAR S/F DAB L Q2. DEALER CLAIMS FRAME IS BROKE WHERE THE BACK POST FIT IN.
THE BALLOON FAILED SOME HRS AFTER PT WAS TRANSFERRED FROM THE CATH LAB TO ICU. MD WAS PRESENT AND APPLIED DIRECT PRESSURE TO THE CATHETER SITE. ANOTHER BALLOON PUMP CATHETER WAS REINSERTED AND PT DID NOT SUSTAIN ANY ILL EFFECTS. FACILITY SUSPECTS DEVICE FAILURE TO BE DUE TO PT'S CONDITION OF L MAIN DISEASE AND CALICFICATION OF ARTERIES.
MOUTH GAG BROKE ON PLACEMENT IN PT'S MOUTH. PT REQUIRED SUTURES.
WHILE USING THE LIGHT PIPE DURING AN EVALUATION, SMOKE COULD BE SMELLED AND THE LIGHT PIPE CONNECTION WAS FOUND TO BE MELTING. SEVERAL LIGHT PIPES WERE CONNECTED UNTIL ONE LIGHT PIPE COULD BE USED FOR THE EVALUATION. THERE WAS NO PT INVOLVEMENT.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED. ANALYSIS SHOWED THAT THIS CALIBRATION CODE, IF USED TO PERFORM AN ASSAY WITH TEST STRIPS FROM ANY LOT, COULD RESULT IN HIGHER THAN EXPECTED VALUES. NO INJURIES REPORTED IN THE FIELD.
ELECTRONIC TESTING OF THE RETURNED SENSOR WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPEC. NO PHYSICIAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPEC. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SEPC.
CASTER HINGE R. CASTER HINGE L. DEALER CLAIMS CASTER HINGES BROKE.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OR THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING AN OPHTHALMIC PROCEDURE, WHEN THE LIGHT PIPE WAS CONNECTED TO THE UNIT, THE PROXIMAL END BURNED IN THE MACHINE SOCKET. THE LIGHT PIPE WAS EXCHANGED AND THE PROXIMAL CONNECTOR WAS CLEARLY DISCOLORED AND PARTIALLY MELTED. ANOTHER LIGHT PIPE WAS USED FOR THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE OR EFFECT ON THE PT.
X-TUBE ASSEMBLY 18" X 15". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC., UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT'S WEIGHT ON THE COT IN SEMI-FOWLERS POSITION CAUSED NUTS/SCREWS ON RELEASE LEVERS ON HEAD AND END OF COT TO JAM CAUSING THE COT TO FREEZE IN THE LOAD POSITION WHICH IS QUITE UNSTABLE. CREW WAS ABLE TO COMPLETELY LOWER THE COT AND LOAD INTO EMS UNIT WITH ADD'L LIFTING ASSISTANCE. NO ADVERSE EFFECT TO THIS PT. IMMEDIATELY FOLLOWING THE EVENT, THE COT WAS TAKEN OUT OF SVC. PROBLEM WAS DUPLICATED BY COT REPAIR SVC. MFR WAS CONTACTED ON 10/14/96 AND ADVISED THEY WOULD FAX MATERIAL ON LIKELY PROBLEM AND TO HAVE HOSP MAINTENANCE WORKERS REPAIR IT. SVC CO COMPLIED WITH SVC RECOMMENDATION ON 10/14/96 AND COT FAILURE CONTINUED. A REPAIR WAS COMPLETED BY POLISHING THE END OF THE BOLTS. THIS ELIMINATED THE OBVIOUS DESIGN PROBLEM ON THIS UNIT WHICH WAS RETURNED TO SVC.
X-TUBE ASSM 10" X 18". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OR THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A DIALYSIS TREATMENT, THE HEPARIN/SALINE LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD.
THE AFFECTED FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN EVAL BECAUSE THE ASSEMBLY WAS DISCARDED BY THE SVC TECH, WHO MISCODED THIS COMPLAINT. HOWEVER, SIMILAR COMPLAINTS (0896037C3, 0796207C3,0796157C3, 0796160C3) AND 0796180C3 INDICATE THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THESE CLAMPS' STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN. SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR# 960027. CUSTOMER CONTACTED: NO. SALES SVC CONTACTED BY INVESTIGATOR? YES. TRAINING REQUIRED? NO. REPORT ATTACHED ? NO.
THREE HIV-INFECTED PTS SEEN IN RPTR'S INSTITUTION WITH ABNORMAL CHEST RADIOGRAPHS AND FLUOROCHROME STAIN-POSITVE SPUTUM WERE EVALUATED FOR TUBERCULOSIS, INCLUDING PERFORMANCE OF THE TEST ON EXPECTORATED SPUTUM SAMPLES. TWO OF THREE PTS' SPUTA WERE HIGHLY SMEAR-POSITIVE (I.E. >100 BACILLI/HIGH POWER FIELD), WHILE THE THIRD PT'S SPUTUM CONTAINED 6-10 BACILLI/HPF. RESULTS ON THE INITIAL SPECIMENS FROM THESE PTS RANGED FROM 43,498 TO 193,858 RLU. MFR DEFINES VALUES >_ 30,000 RLU AS INDICATIVE OF POSITIVE TEST, I.E., THE PRESENCE OF M. TUBERCULOSIS RNA. ALL THREE PTS' SPUTUM CULTURES YIELDED GROWTH OF M. KANSASII WITHIN 6-12 DAYS. ONE PT'S CULTURE ALSO CONTAINED M. AVIUM, BUT NONE OF THE INITIAL OR FOLLOW-UP CULTURES FROM THE PTS REVEALED M. TUBERCULOSIS. HOWEVER, SUBSEQUENT CULTURES FROM ALL THREE PTS AGAIN REVEALED M. KANSASII. OTHER SPUTUM SPECIMENS FROM TWO OF THE PTS THAT HAD ONLY 1+ OR 2+ SMEAR POSITIVITY WERE TEST-NEGATIVE IN 2/3 INSTANCES. A FOURTH PT WITH 1+ SMEAR POSITIVE SPUTUM DUE TO M. KANSASII YIELDED A NEGATIVE TEST. FIVE CULTURES OF M. KANSASII (INCLUDING THESE 4 PTS' ISOLATE AND CULTURES OF SEVERAL OTHER SPECIES WERE EXAMINED AT DENSITIES OF TEST. ALL FIVE ISOLATES OF M. KANSASII AND 3/3  ISOLATES OF M. SIMIAE YIELDED FALSE-POSITIVE TESTS WITH RLU VALUES OF 75,191 TO 335,591. THESE RESULTS INDICATE THAT LOW-LEVEL FALSE-POSITIVE RESULTS CAN OCCUR DUE TO M. KANSASII AND POSSIBLY OTHER MYCOBACTERIUM SPECIES IN SPUTUM. RLU VALUES OF 30,000-400,000 SHOULD BE INTERPRETED WITH CAUTION. ADD'L PTS'S AGES: 40, 44. ADD'L DATES OF EVENT: 4/4/96, 4/5/96.
PT UNDERWENT CATARACT SUREGERY ON 10/11/96, AND IMPLANTATION OF A MODEL AA-4203VF INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, DURING INSERTION THE SURGEON NOTICED THAT THE LENS HAD TORN. WHILE EXPLANTING THE LENS HE TORE THE POSTERIOR CHAMBER AND A VITRECTOMY WAS NECESSARY. THE SURGEON IMPLANTED ANOTHER THREE PIECE LENS, MODEL AQ-2003, AND THE PT IS DOING GOOD.
H6-METHOD, RESULTS AND CONCLUSION: THE LENS PACKAGE WAS RETURNED WITHOUT THE LENS IN THE BOX. THE FACILITY DISCARDED THE PRODUCT. THEREFORE, AN EVAL COULD NOT BE DONE. THE PT'S VISUAL ACUITY IS 20/50 UNCORRECTED AND INTRAOCULAR PRESSURE IS 15MM HG. THE SURGEON STATED THAT THE PROGNOSIS FOR THIS PT IS EXCELLENT.
DURING A DIALYSIS TREATMENT, THE FOUR POSITION LINE CLAMP FAILED, RESULTING IN A BLOOD LOSS OF 50ML. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE VISUAL INSPECTION DETERMINED THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THE FACILITY CLAIMED THAT THIS OCCURRED WITH NORMAL USE. THESE CLAMPS WERE THE VERSION PRODUCED AFTER THE MAY, 1995 ECO 66998 (CONTAINED TWO NARROW RIDGES ON THE THUMB TABS). SAFETY ANALYSIS: IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND / OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR # 960027. CUSTOMER CONTACTED: NO. SALES/SVC CONTACTED BY INVESTIGATOR ? NO. TRAINING REQUIRED? NO. REPORT ATTACHED? NO.
PART WAY THROUGH THE STERNOTOMY PROCEDURE, THE BLADE PROTECTOR BROKE OFF, FALLING INTO THE CHEST. THE SEPARATED SECTION OF THE BLADE PROTECTOR WAS RETRIEVED FROM THE PT'S CHEST. NO PT INJURY HAS BEEN REPORTED AS A RESULT OF THIS INCIDENT.
IN ADDITION, THE SUBMISSION TO THE MEDICAL DEVICE REPORT IS REQUIRED OF DEVICE MFRS BY 21 CFR 803. NEITHER THE SUBMISSION OF INFO BY A MFR PURSUANT TO THIS RULE, NOR PUBLIC RELEASE OF SUCH INFO, CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHED THE EXISTENCE OF ANY CONNECTION BETWEEN A PRODUCT AND ANY DEATH OR INJURY. THE INFO PROVIDED IN THE MEDICAL DEVICE REPORT IS BASED PRIMARILY ON INFO RELATED BY THIRD PARTY SOURCES; THE ACCURACY OF THEIR REPORTS AND VERACITY OF THE SOURCES HAVE NOT BEEN CONFIRMED BY THE REPORTING PARTY. ANY BUSINESS INFO CONTAINED IN THIS REPORT, SUCH AS SALES AND PRODUCTION FIGURES, ARE CONFIDENTIAL INFO AND SHOULD BE TREATED AS SUCH.
REHAB PT SITTING IN WHEELCHAIR. PT STATED SHE WAS TAKING HER SHOES OFF AND THE WHEELCHAIR TIPPED FORWARD. SHE GRABBED THE BED AND CAUGHT HERSELF. THE RIM OF THE FRONT LEFT CASTER CAME OFF WHICH CAUSED IT TO TIP FORWARD. THE PT WAS NOT INJURED. WHEELCHAIR PURCHASED 8/96.
RN REPORTED REACTION TO LATEX GLOVES. SHE EXPERIENCED RESPIRATORY PROBLEMS, WATERY EYES AND HIVES ON HER HANDS. SHE ALSO HAD AN ANAPHYLACTIC REACTION AND HAD TO QUIT WORKING AS AN RN.
6/26/96-PT. HAD APPLICATION OF ANTERIOR LUMBAR PLATE USING SPINE TITANIUM ANTERIOR LOCKING PLATE. 7/2/96-1. LUMBAR DECOMPRESSION L1-L2, T12-L1 AND L2-L3 FOR PLACEMENT OF PEDICLE SCREW. POSTERIOR SPINAL FUSION L1-L3 PEDICLE SCREW FIXATION L1-L3. 7/19/96-READMITTED WITH ABDOMINAL PAIN. TAKEN TO OR.
AS THE PT WAS BEING REWARMED DURING CARDIOPULMONARY BYPASS, THE UNIT DID NOT STOP HEATING AT THE EXPECTED TEMPERATURE OF 30 DEGREE CELSIUS, RESULTING IN THE DELIVERY OF 45 DEGREE CELSIUS WATER TO THE PT. AT THIS TIME, THE UNIT WAS SWITCHED OUT. BOTH THE USER AND THE CO SERVICE REP WERE UNABLE TO DUPLICATE THIS PROBLEM. THE HIGHEST TEMPERATURE THAT WAS MEASURED ON THE PT DURING THE EVENT WAS 25 DEGREE CELSIUS. NO PT INJURY HAS BEEN REPORTED AS A RESULT OF THIS INCIDENT.
IN ADDITION, THE SUBMISSION TO THE MEDICAL DEVICE REPORT IS REQUIRED OF DEVICE MFRS BY 21 CFR 803. NEITHER THE SUBMISSION OF INFO BY A MFR PURSUANT TO THIS RULE, NOR PUBLIC RELEASE OF SUCH INFO, CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED ESTABLISHES THE EXISTENCE OF ANY CONNECTION BETWEEN A PRODUCT AND ANY DEATH OR INJURY. THE INFO PROVIDED IN THE MEDICAL DEVICE REPORT IS BASED PRIMARILY ON INFO RELATED BY THIRD PARTY SOURCES; THE ACCURACY OF THEIR REPORTS AND VERACITY OF THE SOURCES HAVE NOT BEEN CONFIRMED BY THE REPORTING PARTY. ANY BUSINESS INFO CONTAINED IN THIS REPORT, SUCH AS SALES AND PRODUCTION FIGURES, ARE CONFIDENTIAL INFO AND SHOULD BE TREATED AS SUCH. THIS UNIT HAD HAD A PREVENTATIVE MAINTENANCE VISIT FOUR DAYS PRIOR TO THE EVENT. AFTER THE EVENT, A CO SERVICE REPRESENTATIVE INVESTIGATED THE UNIT AND WAS UNABLE TO DUPLICATE THE PROBLEM. FOR THIS EVENT TO OCCUR, THREE THERMOSTATS WOULD HAVE HAD TO HAVE FAILED. AS A PRECAUTION, THE SERVICE REP REPLACED ALL THREE THERMOSTATS, AS WELL AS, THE SOLID STATE RELAY.
DURING A DIALYSIS TREATMENT, THERE WERE SEVERAL "AIR IN BLOOD" ALARMS. THE FACILITY RESET THE ALARM A NUMBER OF TIMES AND EVENTUALLY THEY TURNED THE AIR DETECTOR OFF. IN ADDITION, THE FACILITY REMOVED THE VENOUS BLOOD LINE FROM THE LINE CLAMP. LATER IN THE TREATMENT, AIR WAS NOTED IN THE VENOUS LINE, PAST THE AIR DETECTOR. THE PT COMPLAINED OF CHEST PAINS, SHORTNESS OF BREATH AND A NUMBING SENSATION. THE PT WAS HOSPITALIZED FOR FURTHER EVAL.
NO PRODUCT WAS RETURNED WITH THIS COMPLAINT BECAUSE THIS CONDITION WAS NOT GENERATED BY THE MACHINE. THE FACILITY WAS CONTACTED FOR FURTHER INFO AND CLARIFICATION OF THE REPORTED INCIDENT. THE FACILITY STATED THAT A MANUFACTURING TECHNICIAN WAS NOT CALLED BECAUSE THERE WERE NO DEFECTS WITH THE MACHINE. THEY STATED THAT THE ORIGINAL AIR IN BLOOD ALARMS WERE IN FACT ACTUAL ALARMS, BUT THE OPERATOR DID NOT UNDERSTAND WHAT TO DO. THUS, THE OPERATOR RESET THE ALARM WITHOUT DETERMINING THE ROOT CAUSE OF THE ALARMS. THE OPERATOR THEN BECAME FRUSTRATED WITH THE ALARMS AND TURNED THE AIR DETECTOR OFF AND PULLED THE VENOUS BLOOD LINE OUT OF THE LINE CLAMP. THE FACILITY STATED THAT THE AIR DETECTOR WAS OFF FOR APPROX 10 MINS WHEN THE AIR WAS NOTED IN THE VENOUS LINE. THE PT IS IN A STABLE CONDITION AND IS DOING FINE AS OF 10/23/96. THE FACILITY ADMITTED THAT THIS CONDITION WAS CAUSED DUE TO MISUSE BY THE OPERATOR. AN AIR IN BLOOD ALARM, AS DESCRIBED IN SECTION 4-6 OF THE OPERATOR'S MANUAL, VERSION 4/1992, RESULTS IN A VISUAL AND A STEADY AUDIBLE ALARM. IN SECTION 3-28 IT FURTHER STATES THAT THE AIR BUBBLE DETECTOR MUST BE ON AND THE VENOUS LINE MUST BE PLACED CORRECTLY IN THE LINE CLAMP BEFORE AND DURING A DIALYSIS TREATMENT. IF THIS IS NOT COMPLETED PER THE OPERATOR'S MANUAL IT IS CONSIDERED TO BE MISUSE BY THE FACILITY BECAUSE THE MACHINE CANNOT PROTECT THE PT AS IT WAS DESIGNED TO, THIS IS A CLEAR FAILURE TO FOLLOW NOT ONLY THE LABELING BUT ALSO GENERAL SAFETY PRACTICES COMMON TO ALL DIALYSIS FACILITIES. THE ABOVE INFO INDICATES THAT THE PT INJURY DESCRIBED IN THIS COMPLAINT WAS GENERATED DUE TO MISUSE BY THE FACILITY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED: YES. DATE 10/23/96. SALES SVC CONTACTED BY INVESTIGATOR? YES. TRAINING REQUIRED? NO. REPORT ATTACHED? NO.
EVENT COULD NOT BE EVALUATED SINCE HOSPITAL COULD NOT PROVIDE DEVICE OR LOT NUMBERS. "SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFO WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR IT'S EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR IT'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.
PT BEING TREATED IN ER AND GIVEN AN ICE PACK TO PUT ON HER HEAD. THE ICE PACK LEAKED INTO HER LEFT EYE. THE PT'S EYE WAS FLUSHED WITH COPIUS AMOUNTS OF NORMAL SALINE. A DROP OF OPTHANE WAS PUT IN EYE AND A FLUORESCEIN EXAM SHOWED NO UPTAKE.
AN AMBULANCE WAS CALLED TO THE HOME OF A MALE PT WHO WAS REPORTEDLY "OUT OF BREATH". THE RPTR BELIEVES THE PT HAD BEEN DIAGNOSED WITH COPD AND WAS HAVING A "BAD EPISODE". THE RESCUE PERSONNEL REPORTED THE PT TO BE "DUSKY" IN APPEARANCE AND ADMINISTERED OXYGEN DUE TO THE PT'S CONDITION. ALLEGEDLY, MODEL N-20 PULSE OXIMETER USED IN COMBINATION WITH CO MODEL DS-100A OXYGEN TRANSDUCER DISPLAYED AN OXYGEN SATURATION READING OF 97%. THE RESCUE PERSONNEL DISREGARDED THE READINGS AND "SWAPPED THE ENTIRE SET-UP WITH ANOTHER SYSTEM" WHICH REPORTEDLY DISPLAYED AN OXYGEN SATURATION LEVEL OF 66%.
THE N-20 AND DS-100A WERE RETURNED TO CO'S SERVICE CENTER FOR TESTING. THE N-20 UNDERWENT EXTENSIVE TESTING INCLUDING LOW SATURATION SIMULATION. THE N-20 AND DS-100A WERE ALSO TESTED AS A SYSTEM FOR READINGS FUNCTIONALITY BY COMPARING READINGS TO A CONTROL SYSTEM. IN ADDITION, BOTH PRODUCTS WERE PUT INTO AN ENVIRONMENTAL STRESS CHAMBER AND THEN RETESTED. ALL TESTS PERFORMED SHOW THE RETURNED N-20 AND DS-100A ARE PERFORMING TO CO'S SPECIFICATIONS. BOTH PRODUCTS HAVE BEEN SENT TO CO'S CLINICAL STUDIES LABORATORY FOR MORE TESTING. THE AGENCY WILL BE INFORMED OF CO'S FINDINGS.
CYSTOSCOPE WAS FORCED THROUGH TIGHT SHEATH; SMALL METAL SHAVINGS HAD TO BE REMOVED FROM PT'S BLADDER.
ADD'L INFO HAS BEEN REQUESTED FROM HOSP.
REPORTER STATES THAT ON THREE OCCASIONS THE 30 GAUGE STERILE NEEDLE BROKE. THE FIRST TWO INDCIDENTS OF BREAKAGE OCCURRED WHILE THE NEEDLES WERE BEING HANDLED BY THE CLINICIAN AND DID NOT INVOLVE INJURY TO A PT. ON THE THIRD OCCASION THE NEEDLE BROKE OFF WHILE IN A PT'S MOUTH DURING INJECTION OF ANESTHETIC. THIS REPORT REFLECTS THAT INCIDENT. ON 1/10/96 A 30 GAUGE STERILE DENTAL NEEDLE WAS USED TO ADMINISTER ANESTHETIC TO A PT PRIOR TO AN UNSPECIFIED DENTAL PROCEDURE. TWO CARTRIDGES OF ANESTHETIC WERE ADMINISTERED VIA INFERIOR ALVEOLAR BLOCK. THE INJECTION OF THE FIRST CARTRIDGE WAS COMPLETED WITHOUT DIFFICULTY. PRIOR TO THE INJECTION OF THE SECOND CARTRIDGE, THE NEEDLE WAS BENT SLIGHTLY. DURING THE SECOND INJECTION THE NEEDLE BROKE AND A PORTION WAS IMBEDDED IN THE PT. THE PT WAS SEDATED, AN X-RAY WAS TAKEN, AND THE NEEDLE PORTION WAS RETRIEVED BY AN ORAL SURGEON. THE PT HAS RECOVERED. REFER TO ASSOCIATED EVENT 967417P0531 FOR RELATED REPORT.
REPORTER STATES THAT ON THREE (3) OCCASIONS THE 30G STERILE NEEDLE BROKE. THE FIRST TWO (2) INCIDENTS OF BREAKAGE OCCURRED WHILE THE NEEDLES WERE BEING HANDLED BY THE CLINICIAN AND DID NOT INVOLVE INJURY TO A PT. ON THE THIRD OCCASION THE NEEDLE BROKE OFF WHILE IN A PT'S MOUTH DURING INJECTION OF ANESTHETIC. THIS REPORT REFLECTS THAT INCIDENT. ON 10/1/96 A 30G STERILE DENTAL NEEDLE WAS USED TO ADMINISTER ANESTHETIC TO A PT PRIOR TO AN UNSPECIFIED DENTAL PROCEDURE. TWO CARTRIDGES OF ANESTHETIC WERE ADMINISTERED VIA INFERIOR ALVEOLAR BLOCK. THE INJECTION OF THE FIRST CARTRIDGE WAS COMPLETED WITHOUT DIFFICULTY. PRIOR TO THE INJECTION OF THE SECOND CARTRIDGE, THE NEEDLE WAS BENT SLIGHTLY. DURING THE SECOND INJECTION THE NEEDLE BROKE AND A PORTION WAS INBEDDED IN THE PT. THE PT WAS SEDATED, AN X-RAY WAS TAKEN AND THE NEEDLE PORTION WAS RETRIEVED BY AN ORAL SURGEON. THE PT HAS RECOVERED.
AT APPROX 7:30 PM PT WAS FOUND IN HER ROOM IN HER WHEELCHAIR SLID FORWARD TO THE FLOOR, WITH HER QUICK RELEASE BELT AROUND HER NECK, AND ACROSS HER CHEST. THE CHARGE NURSE WAS IMMEDIATELY SUMMONED, VITAL SIGNS WERE TAKEN WITH NO VIABLE SIGNS.
THE SWITCH EMITTED SMOKE. CO'S INSPECTION REVEALED THE SWITCH SMOKED. THE CASE HAS BEEN CHANGED TO ELIMINATE THIS PROBLEM. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IF YES, THEN IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IF YES, THEN IS SEVERITY OF THIS EVENT GREATER THAN LABELED? N.
WHEN THE 82 YR OLD FEMALE PT COMPLAINTED OF LOWER ABDOMINAL PAIN FOLLOWING COLONSCOPY, AN X-RAY WAS TAKEN AND PERFORATION OF THE COLON WAS CONFIRMED. THE PT UNDERWENT AN EMERGENCY EXPLORATORY LAPAROTOMY AND RESECTION OF THE SIGMOID COLON AND WAS DISCHARGED IN STABLE CONDITION SEVERAL DAYS LATER. THE EQUIPMENT WAS EXAMINED BY HOSPITAL PERSONNEL AND NO DEFECTS WERE FOUND. HOSPITAL PERSONNEL ALSO BELIEVE THAT THE PROBLEM APPEARS TO BE MORE THE RESULT OF THE PT'S OVERALL POOR GASTRIC CONDITION (SEVERE STRICTURES) RATHER THAN USER ERROR.
ON 10/19/96, THE RESIDENT AT 5:10 AM WAS FOUND NONRESPONSIVE IN A SITTING POSITION WITH HER LEGS OUT IN FRONT OF HER. THE RESIDENT WAS ON THE FLOOR NEXT TO HER BED WITH THE WAIST SAFETY DEVICE/RESTRAINT STILL AROUND HER WAIST TIED TO THE BED. THE STAFF ATTEMPTED TO AROUSE RESIDENT AND HAD TO FREE HER FROM THE WAIST SAFETY DEVICE/RESTRAINT BY CUTTING THE TIES. AT THAT TIME, THE RESIDENT WAS NONRESPONSIVE AND HAD NO PULSE, RESPIRATION OR BLOOD PRESSURE. THE RESIDENT'S SKIN WAS WARM WITH PALE COLOR TO UPPER BODY AND BEGINNING BLUENESS IN FEET. THIS HAS BEEN REPORTED TO THE STATE DEPT OF PUBLIC HEALTH AND ENVIRONMENT.
PT FOUND TO HAVE A PIECE OF A BROKEN CATHETER IN THE LEFT SUBCLAVIAN FEMORAL VEIN. MULTIPLE HOSP ADMISSIONS SINCE 1988. UNABLE TO DETERMINE WHERE THIS CATHETER HAD BEEN IMPLANTED.
THE UNIT BURNED. CO'S INSPECTION REVEALED A 1/4" DIAMETER BURN HOLE THROUGH ONE SIDE OF PAD CAUSED BY THERMOSTAT CONNECTION ARCING. NO DEATHS OR INJURIES WERE REPORTED. FURTHER COMMUNICATION WITH THE USER INDICATED SHE LAYED ON THE UNIT WHICH WAS CONTRARY TO THE HOW-TO-USE INSTRUCTION BOOKLET.
FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IF YES, THEN IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING?. Y. IF YES THEN IS SEVERITY OF THIS GREATER THAN LEBELED? N.
THE CUSTOMER REPORTED INACCURATELY LOW READINGS WITH TEST STRIPS. THE CUSTOMER STATED THAT TEST STRIPS FROM THE FIRST BOTTLE PERFORMED ACCURATELY. HE OPENED THE SECOND BOTTLE ON 8/23/96, AND MOST OF THE STRIPS PERFORMED ACCURATELY. HOWEVER TOWARD THE END OF THE BOTTLE, HE NOTICED THAT THE READINGS WERE GETTING LOWER AND LOWER. THE REP WAS UNABLE TO PERFORM A NORMAL CONTROL SOLUTION TEST WITH THE CUSTOMER BECAUSE HE DID NOT HAVE NORMAL CONTROL SOLUTION. WITH THE REP, THE CUSTOMER PERFORMED A CHECK STRIP TEST. THE RESULT WAS 78 VERSUS A RANGE OF 68-96. THE DESICCANT IS IN THE BOTTLE. THE CUSTOMER STORES HIS TEST STRIPS IN THE BEDROOM. THE CUSTOMER HAS ONLY THREE TEST STRIPS LEFT. ADD'L INFO. THE CUSTOMER STATED THAT TEST STRIPS FROM THE FIRST BOTTLE PERFORMED ACCURATELY. CUSTOMER THEN STATED THAT MOST OF THE STRIPS FROM THE SECOND BOTTLE PERFORMED ACCCURATELY. HOWEVER, TOWARD THE END OF THE SECOND BOTTLE, HE NOTICED THAT THE READINGS WERE GETTING LOWER AND LOWER. THIS INDICATES THAT IT IS LIKELY THAT THE DECREASE OF BLOOD GLUCOSE READINGS FOR THE SECOND BOTTLE MIGHT HAVE BEEN DUE TO THE CUSTOMER'S HANDLING AND STORAGE OF THE PRODUCT. THE RETENTION SAMPLE TEST RESULTS FOR DEVICE CONTINUE TO PROVIDE ACCEPTABLE PERFORMANCE INDICATING NO TREND OF PRODUCT DEGRADATION. CO REQUESTED THAT PRODUCT BE RETURNED FOR EVAL ON 9/30/96. AS OF 10/23/96, RETURNED PRODUCT HAS NOT BEEN REC'D. CO WILL FORWARD A FOLLOW UP TO THIS REPORT UPON RECEIPT OF RETURNED TEST STRIPS AND THEIR EVAL. TIME FRAME IS UNK. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? UNK. IS EVENT OCCURING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURING WITH GREATER SEVERITY THAN STATED IN LABELING? YES. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO.
THE CUSTOMER STATED THAT TEST STRIPS FROM THE FIRST BOTTLE PERFORMED ACCURATELY. CUSTOMER THEN STATED THAT MOST OF THE STRIPS FROM THE SECOND BOTTLE PERFORMED ACCURATELY. HOWEVER, TOWARD THE END OF THE SECOND BOTTLE, HE NOTICED THAT THE READINGS WERE GETTING LOWER AND LOWER. THIS INDICATES THAT IT IS LIKELY THAT THE DECREASE OF BLOOD GLUCOSE READINGS FOR THE SECOND BOTTLE MIGHT HAVE BEEN DUE TO THE CUSTOMER'S HANDLING AND STORAGE OF THE PRODUCT. THE RETENTION SAMPLE TEST RESULTS FOR DEVICE CONTINUE TO PROVIDE ACCEPTABLE PERFORMANCE INDICATING NO TREND OF PRODUCT DEGRADATION. CO REQUESTED THAT PRODUCT BE RETURNED FOR EVAL ON 9/30/96. AS OF 10/23/96, RETURNED PRODUCT HAS NOT BEEN REC'D. CO WILL FORWARD A FOLLOW UP TO THIS REPORT UPON RECEIPT OF RETURNED TEST STRIPS AND THEIR EVAL. TIME FRAME IS UNK. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? UNK. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? YES. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO.
A PT WAS TESTED USING THE GROUP B STREP ASSAY LOT NUMBER 690445. THE PERSTON REPORTING THE INCIDENT BELIEVES BUT IS NOT CERTAIN THAT THE SAMPLE WAS OBTAINED JUST PRIOR TO DELIVERY OF THE INFANT. A DUPLICATE SPECIMEN OBTAINED AT THE SAME TIME WAS USED TO STREAK A CULTURE PLATE. THE RESULT OF THE ASSAY WAS NEGATIVE. THE CULTURE RESULT WAS POSITIVE FOR GROUP B STREP. THE CULTURE WAS CONFIRMED WITH A STREP TYPING KIT, MFR UNKNOWN. THE INFANT WAS VERY SICK UPON DELIVERY AND SUBSEQUENTLY DIED. A BLOOD CULTURE FROM THE INFANT WAS PERFORMED AND THE RESULTS WERE NEGATIVE FOR GROUP B STREP. IT WAS LATER DETERMINED THAT THE INFANT DIED FROM ASPHYXIA. NO SAMPLE OR KIT WAS RECEIVED FROM THE CUSTOMER FOR TESTING; THEREFORE, THE COMPLAINT FOR CULTURE POSITIVE. NEGATIVE COULD NOT BE EVALUATED. TESTING WAS PERFORMED AT CO USING AN IN-HOUSE KIT OF THE SAME LOT NUMBER.
THE SUBMISSION OF THIS MEDICAL DEVICE REPORT IS REQUIRED OF DEVICE MFRS BY 21 CFR PART 803. NEITHER THE SUBMISSION OF INFO BY CO PURSUANT TO THIS RULE, NOR THE PUBLIC RELEASE OF SUCH INFO, CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CONNECTION BETWEEN THE PRODUCT AND ANY DEATH OR INJURY. NEGATIVE CONTROL, POSITIVE CONTROL AND A SENSITIVITY SAMPLE WERE TESTED AND PRODUCED THE FOLLOWING RESULTS. SAMPLE NEGATIVE CONTROL, EXPECTED RESULTS,1/1 VISUALLY NEGATIVE, RESULT 1/1 VISUALLY NEGATIVE, POSITIVE CONTROL 1/1 VISUALLY POSITIVE 1/1 VISUALLY POSITIVE, SENSITIVITY SAMPLE 3/3 VISUALLY POSITIVE 2/3 VISUALLY POSITIVE. THE STREP B LABELING CLEARLY SPECIFIES THAT NEGATIVE RESULTS MUST BE CONFIRMED WITH CULTURE. THE LIMITATIONS SECTION FROM THE STREP B DIRECTIONAL INSERT ARE: THE STREP B ASSAY IS INTENDED TO AID IN THE DETECTION OF GROUP B STREPTOCOCCUS ANTIGEN FROM VAGINAL OR CERVICAL SWAB SPECIMENS OBTAINED FOR PRETERM AND INTRAPARTUM MATERNITY PTS. STREP B IS NOT INTENDED FOR DISTINGUISHING WHETHER THE SPECIMEN IS FROM A COLONIZED OR AN INFECTED INDIVIDUAL. STREP B IS NOT INTENDED TO BE USED AS A SUBSTITUTE FOR BACTERIAL CULTURE. NEGATIVE RESULTS USING THE STREP B ASSAY MUST BE CONFIRMED WITH CULTURE. STREP B ASSY RESULTS MUST ALWAYS BE INTERPRETED BY THE PHYSICIAN IN CONJUNCTION WITH OTHER PERTINENT CLINICAL AND LABORATORY DATA.
PT WAS POST-OP FROM SURGERY TO REPAIR A MESENTERIC ARTERY INJURY SUSTAINED FROM A MOTOR VEHICLE ACCIDENT. CHEST X-RAY AND KUB X-RAY REVEALED LAP SPONGES RETAINED IN BODY CAVITY FROM SURGERY. PT HAD TO BE RETURNED TO SURGERY FOR REMOVAL OF THREE LAP SPONGES.
AN EMPLOYEE WAS OPERATING THE LIFT INCORRECTLY. THIS EMPLOYEE WAS PUSHING THE "UP" BUTTON ON THE HAND CONTROL WHILE STILL ATTACHED TO THE LIFT. THE HAND CONTROL HAD BEEN LEFT ON THE "MAST" FACING THE "ACTUATOR." AS THE LIFT WAS RISING, THE ACTUATOR MOVED IN PRESSING HER FINGER ONTO THE "UP" SWITCH. THIS EMPLOYEE'S FINGER WAS TRAPPED AND SHE RECEIVED A MAJOR CONTUSION AND IS UNDER A DR'S CARE FOR TRAUMA.
NEEDLE PENETRATED THROUGH FRONT OF SHARPS COLLECTOR RESULTING IN A NEEDLE STICK TO NURSE.
PRODUCT LABELING AND DIRECTIONS FOR USE (COPIES ATTACHED) WARN THAT THESE UNITS ARE PUNCTURE-RESISTANT BUT NOT NECESSARILY PUNCTURE PROOF.
FOUR HRS POST-OP, X-RAY OF "R" KNEE REVEALED OBVIOUS PIECE OF SCREW FROM INSTRUMENTATION FEMORAL JIG.
THE DEVICE WAS USED FOR APP. 5 HRS ON OXYGENATOR SUPPORT WHEN YELLOW FOAM WAS NOTED EXITING THE OXYGENATOR. THE UNIT WAS CHANGED OUT AND NO PT COMPROMISE WAS NOTED. OXYGENATOR SUPPORT IS AN OFF-LABELED USED OF THE DEVICE.
TESTING ON RETURNED DEVICE NOTED PLASMA BREAKTHROUGH. THE OXYGENATOR WAS RECEIVED ON 10/2/96 FOR COMPLAINT EVALUATION. THE RETURNED DEVICE WAS SET-UP IN A SIMULATED PERFUSION CIRCUIT. TESTING WAS PERFORMED WHEREBY 30 MINUTES INTO THE TEST, PLASMA BREAKTHROUGH WAS NOTED BY THE TECHNICIAN. THE EFFLUENT WAS COLLECTED AND A SPECIFIC GRAVITY ANALYSIS WAS CINDUCTED. THE RESULTS INDICATED THAT THE SPECIFIC GRAVITY WAS WITHIN THE KNOWN LIMITS OF PLASMA. DISCLAIMER: THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIVISION, ITS OFFICERS, EMPLOYEES, OR AGENTS.
PT WAS IN THE SHOWER CHAIR WHEN THE PIECE OF PVC TUBING HOLDING THE TOILET SEAT IN PLACE BROKE, CAUSING THE PT TO SLIDE FORWARD AND DOWN SCRATCHING HIS BUTTOCKS AND UPPER BACK. FURTHER INJURY WAS PREVENTED BY CARE GIVERS CATCHING THE PT BEFORE HE COULD FALL ALL THE WAY TO THE FLOOR.
THE PUMP FAILED ON BATTERY MODE AFTER 15 MINUTES OF USE. THE PT WAS IN TRANSIT TO ANOTHER HOSP WHEN THIS MALFUNCTION OCCURRED. THERE WERE NO PT COMPLICATIONS.
THE FIELD SERVICE REP INVESTIGATED THIS INCIDENT. HE FOUND THAT THE BATTERIES WERE AT LEAST 3 YRS OLD, AND THIS WAS A ROUTINE FAILURE ASSOCIATED WITH AGING BATTERIES. THE SERVICE PERFORMED WAS REPLACEMENT OF THE BATTERY, 14 V POWER SUPPLY, INTERFACE BLOCK, AND ASSOCIATED TUBING. THE PUMP WAS CHECKED FOR FUNCTION AND RAN NORMALLY.
A BLOOD STAIN WAS FOUND IN 2 NEWLY OPENED NEEDLES PRIOR TO USE. A REDDISH STAIN WAS IDENTIFIED ON THE SLEEVES OF THE NEEDLE PORTION THAT IS USED TO PENETRATE THE RUBBER CAP OF THE BLOOD COLECTION TUBE. RED BLOOD CELLS WERE IDENTIFIED IN THE STAIN.
DURING DIALYSIS AN ARTERIAL PRESSURE, A VENOUS PRESSURE AND A LEVEL DETECTOR ALARM OCCURRED. THE ALARMS WERE AUDIBLE AND VISUAL, THE BLOOD PUMP STOPPED, AS EXPECTED. THE VENOUS LINE OCCLUDING CLAMP DID NOT CLOSE, AS EXPECTED WITH BLOOD ALARMS. THE TREATMENT WAS DISCONTINUED. NO PT INJURY OCCURRED. THE MACHINE WAS INSPECTED BY THE FACILITY MACHINE TECHNICIAN. THE MALFUNCTIONING COMPONENT WAS REPLACED AND THE MACHINE HAS BEEN OPERATING PROPERLY SINCE.
THIS COMPONENT WAS MADE BY ANOTHER MFR. FOLLOW UP WITH THE MFR IS IN PROGRESS.
THIS REPORT WAS DETERMINED TO BE NECESSARY AS A RESULT OF A COMPLAINT RECEIVED BY THE MFR, ON ONE OF ITS PRODUCTS AN APNEA MONITOR. PT RECEIVED ELECTRICAL SHOCK WHILE CONNECTED TO APNEA MONITOR (NOTE: SAFETY LEAD WIRES WERE IN USE. THIS EVENT IS UNRELATED TO THE PROBLEMS/RISKS ASSOCIATED WITH USE OF NON SAFETY LEAD WIRES). CUSTOMER WAS CONTACTED FOR ADD'L INFO CONCERNING THE ALLEGED PROBLEM. FOLLOWING IS THE INFO OBTAINED FROM THE COGNIZANT REGISTERED RESPIRATORY THERAPIST (RRT), THE HEALTHCARE PROFESSIONAL WHO WAS RESONSIBLE FOR THE PT: A. RECEIVED A CALL FROM THE MOTHER. STATED THAT SHE FELT ALOT OF ELECTRICITY AROUND THE BABY WHEN THE MONITOR WAS IN USE. RRT ASKED FOR MORE INFO. MOTHER STATED THAT WHEN THEY WERE AROUND THE BABY OR TOUCED THE BABY THEY GOT SHOCKED. B. RRT WAS NOT SURE OF THE EXACT SITUATION AFTER SPEAKING WITH THE MOTHER. DECIDED TO VISIT THE HOME AND CHECK OUT THE UNIT. C. THE FAMILY LIVES IN A VERY OLD HOUSE. UPON ARRIVAL, RRT NOTED THAT THE BABY WAS IN A WHITE WICKER BASSINET. NO CARPETING WAS IN THE AREA. THE FLOOR IS WOOD. RRT FOUND THAT WHEN SHE TOUCHED THE BABY SHE RECEIVRD A SHOCK. WHEN RRT TOUCHED THE MONITOR BAG SHE RECEIVED A SHOCK. RRT STATED THAT THE SHOCK WAS UNLIKE STATIC. IT FELT LIKE A PAINFUL SHARP STING. D. RRT PROCEEDED TO UNPLUG THE  UNIT. NOTICED THAT THE PLUG WAS HOT. RRT ALSO NOTICED THAT WHEN SHE UNPLUGGED THE CORD THE PRONGS WERE TOO HOT TO TOUCH. UNIT WAS PLUGGED IN TO A GROUNDED OUTLET. NO EXTENSION CORD OR GROUND-REMOVING ADAPTERS WERE BEING USED. E. RRT STATED THAT A BEDSIDE NURSERY MONITOR (RADIO TRANSMITTER) WAS PLUGGED INTO THE SAME OUTLET AND IT WAS ACTING NORMALLY. RRT ASKED THE MOTHER IF SHE HAD TRIED DIFFERENT PLUGS. THE MOTHER SAID THEY HAD TRIED DIFFERENT PLUGS BOTH UPSTAIRS AND DOWNSTAIRS. THE MOTHER SAID IT EXHIBITED SAME PROBLEM (NOT VERIFIED BY RRT). BABY WAS ACTING AS IF UNCOMFORTABLE. THE MOTHER DID NOT REPORT ANY PROBLEM WITH THE BABY AS A RESULT OF THIS PHENOMENON. OTHER FACTS: DATE MONITOR ASSIGNED TO PT: 7/5/96, INCIDENT DATE: DATE: 7/24/96, PT BORN 6/15/96. H. RRT THEN REMOVED THE UNIT FROM THE HOME AND TOOK IT BACK TO CH AND WAS UNABLE TO DUPLICATE THE PROBLEM. UNIT WAS SHIPPED WITH THE CHARGER VIA UPS ON 8/19/96. UNIT ARRVIED 8/21/96. NOTIFICATION TO CO 8/21/96.
DESCRIPTION OF "OTHER" IN BLOCK H1= ON THE BASIS OF PRODUCT ANALYSIS/TESTS IBI WAS ABLE TO PERFORM, IT WAS DETERMINED THAT THE DEVICE DID NOT MALFUNCTION. THEREFORE, THE MALFUNCTION BLOCK WAS NOT CHECKED (AND "DEATH" OR "SERIOUS INJURY" DO NOT APPLY). CURRENT DRAW MEASURED 282MA (MONITOR OFF), AND 290MA (MONITOR ON). THESE MEASUREMENTS ARE NORMAL. S/N 23086 WAS THEN OPENED UP AND INSPECTED FOR ANY EVIDENCE THAT MIGHT SUGGEST THAT THE UNIT COULD HAVE BEHAVED OR CONTRIBUTED TO THE REPORTED INCIDENT: SHORT/OPEN CIRCUITS, BROKEN COMPONENTS, COMPONENTS WITH EVIDENCE OF OVERHEATING, LOOSE/BROKEN WIRES, POTENTIAL SHORT CIRCUITS, OTHER DAMAGE. NOTHING UNUSUAL WAS DETECTED. COMPLETE TESTS WERE RUN WITH NO FAILURE. REVIEWED HISTORY RECORD FOR S/N 23086 AND FOUND NO UNUSUAL EVENTS IN PRIOR RETURNS TO THE FACTORY. PAST HISTORY: 1 SOLD 11/12/91, 4 BATTERY REPLACED, 8 25/93, 2) MEMORY FAULT, 6/9/92 5) BATTERY REPLACED, 4/17/96, 3) CHARGER REPLACEMENT, 4/12/93. NO PROBLEM COULD BE FOUND WITH S/N 23086; THE UNIT FUNCTIONS IN ACCORDANCE WITH ITS SPECIFICATIONS. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, MFR, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THIS REPORT CONTAINS INFO REPORTED TO IBI AND MAY NOT CONTAIN OUR REPRESENTATION OF FACT AFTER FURTHER INVESTIGATION. NEITHER THE SUBMISSION OF THIS OR OTHER INFO TO THE FDA NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHED THE EXISTENCE OF ANY CAUSAL CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
PT FOUND UNRESPONSIVE WITH SLOW RESPIRATIONS. PCA PUMP READ ONLY 27.9 CC TOTAL DOSE, 60CC SYRINGE EMPTY WITH PLUNGER STUCK AT 30CC'S WITH AIR ONLY AND NO MORPHINE. 30CC'S OF MORPHINE HAD FREE FLOWED INTO PT IN APPROX 20 MINS. NARCAN ADMINISTERED TO PT AND SHE WAS TRANSFERRED TO ICU. TEST OF PCA PUMP WAS NEGATIVE. TEST OF SYRINGE REVEALED THAT WHEN LIQUID REACHED THE 30CC FREE FLOWED OUT OF THE SYRINGE.
THE LENS SPLIT ONCE INSIDE THE PT'S EYE". NO OTHER DETAILS WERE PROVIDED. IN FOLLOW-UP WITH THE INITIAL REPORTER, THE LENS REMAIN "IN SITU" AND THE CRACK OCCURRED IN THE HAPTIC NOT IN THE VISUAL FIELD. THE SURGEON DID NOT  WISH TO PROVIDE ANY ADD'L INFO.
AN INVESTIGATION OF BATCH RECORDS SHOWED THAT ALL RELEASE CRITERIA WERE MET. MANUFACTURER CONCLUSION: NO PRODUCT DEFECT FOUND. NO FURTHER INFORMATION IS EXPECTED.
DURING AN MRI PROCEDURE, AN ANESTHESIZED PT WAS BEING MONITORED WITH AN ECG MONITOR. FOLLOWING THE PROCEDURE, PT WAS RELEASED WITH NO EVIDENCE OF SKIN BURNS. ONE WEEK LATER (ON 9/17/96) THE PT RETURNED FOR ANOTHER MRI SCAN, AND EVIDENCE OF 2 SKIN BLISTERS WAS OBSERVED WHERE THE RA AND LA ECG ELECTRODES WERE POSITIONED DURING THE MRI SCAN 1 WEEK EARLIER. BOTH BLISTERS WERE APPROX "DIME-SIZED" AND HEALING. PT DID NOT REPORT ANY SENSATION OF SKIN DISCOMFORT UPON RECOVERY FROM ANESTHESIA. ECG ELECTRODE CONTACT IS SUSPECT SINCE ELECTRODES DID NOT HAVE SUFFICIENT ELECTROLYTE EVIDENT.
FEMALE PT WEIGHED 195 LBS. THE SCAN WAS PERFORMED IN A MRI IMAGING SYSTEM. LENGTH OF THE SCAN WAS REPORTED TO BE APPROX 42 MINS. PT WAS UNDERGOING A SERIES OF LUMBAR SPINE SCANS WHILE BEING MONITORED WITH THE ECG PORTION OF THE MONITOR. IT IS NOT KNOWN IF SHE WAS CONTACTING THE BORE WALL, BUT DUE TO THE INFO AVAILABLE, PORTIONS OF HER BODY MAY HAVE BEEN IN CONTACT WITH THE MR MAGNET BORE WALL. PT WAS DESCRIBED AS BEING "VERY TIGHT" INSIDE THE MRI BORE. PT WAS IN A HEAD-IN-FIRST POSITION INSIDE THE BORE. THE ECG CABLE INCLUDES 4 LEAD WIRES TO BE ATTACHED TO ECG ELECTRODES ON THE PT'S CHEST (THE ADD'L LEAD ACTS AS A REFERENCE TO REDUCE MRI GRADIENT NOISE FOUND WITHIN THE MRI BORE). IN ADDITION TO THE ECG ELECTRODES AND CABLE BEING USED, THE MONITOR'S PULSE OXIMETER, END TIDAL CO2 AND NIBP PARAMETERS WERE BEING USED. ALSO, THE CTL PHASED ARRAY SURFACE COIL WAS USED. THE PT REC'D GENERAL ANESTHESIA DURING THE PROCEDURE. PT WAS ANESTHESIZED DURING THE SCAN. FOLLOWING THE MR SCANS, SHE DID NOT REPORT FEELING ANY SENSATION OF HEAT OR SKIN BURNS. SIX SEPARATE MRI SCAN SEQUENCES WERE PERFORMED, WITH THE LONGEST TAKING JUST UNDER 6.5 MINUTES. NO BURNS WERE NOTED AFTER REMOVAL OF THE PT FROM THE MRI BORE WHEN THE ECG ELECTRODES WERE REMOVED FROM THE PT'S CHEST. THE PT WAS DISCHARGED FROM THE RECOVERY AREA (WHICH GENERALLY TAKES LONGER THAN 2 HOURS) AND NO EVIDENCE OR REPORT OF SKIN BURNS WERE DESCRIBED AT THIS TIME. ONE WEEK LATER ON 9/17/ PT RETURNED TO THE HOSP FOR A FOLLOW-UP MRI SCAN, AND THE MRI STAFF NOTED TWO SKIN BLISTERS WHERE THE ECG ELECTRODES HAD BEEN POSITIONED THE WEEK BEFORE. PT DESCRIBED THAT THE SKIN BENEATH THE RL AND LL ELECTRODES WERE ORIGINALLY REDDENED BUT HAD RETURNED TO NORMAL BEFORE HER RETURN TO THE MRI ON 9/17. THE SKIN BENEATH THE RA AND LA ELECTRODES WERE EACH DESCRIBED AS HAVING A "DIME-SIZED" BLISTER (APPROX A 1.6 CENTIMETER BLISTER). NO INFO FOR TREATMENT OF PT SKIN BURNS HAS BEEN REPORTED BY THE HOSP. BOTH BLISTERS WERE DESCRIBED AS HEALING BY AN ANESTHESIOLOGIST WHO EXAMINED THE BLISTERS. THE TRANSMIT-GAIN OF THE SIX DIFFERENT INDIVIDUAL MR SCAN SEQUENCES RANGED FROM 172 TO 196 (200 IS THE MAXIMUM PERMITTED WITHOUT USER INTERACTION BY THE MRI SYSTEM). THE RECOMMENDED CO'S ECG CABLE WAS USED DURING THE SCANS. THE PT CABLE WAS DESCRIBED AS BEING PLACED ATOP THE PT'S CHEST IN THE CENTER OF THE MRI BORE, WHICH IS THE RECOMMENDED PLACEMENT. THE ECG ELECTRODES USED WERE DESCRIBED AS 3M RED DOT, TYPE 2246 AG/AG CL ELECTRODES, AND ARE THE TYPE RECOMMENDED BY CO. DURING THE CONVERSATION WITH THE MRI TECHNOLOGIST AND ANESTHESIOLOGIST WHO WERE INVOLVED WITH THE MRI PROCEDURE, IT WAS REPORTED THAT ECG ELECTRODES DID NOT CONTAIN THE NORMAL AMOUNT OF ECG ELECTROLYTE WHICH IS NORMALLY SEEN IN THESE ELECTRODES. ALSO, THE SPONGE GEL PAD (WHICH RETAINS THE ELECTROLYTE) WAS NOT SEEN AS CENTERED IN THESE ELECTRODES. THE ELECTRODES WERE NOT STORED IN THE MFR'S RECOMMENDED CONFIGURATION BY THE USERS PRIOR TO USE (*).
PT UNDERGOING HEMODIALYSIS. 5 MINS INTO PROCEDURE, FILTER SHOWED SMALL BLOOD LEAK AND WAS CHANGED TO ANOTHER CO'S DIALYZER AND TREATMENT COMPLETED UNEVENTFULLY. HRS LATER, PT STARTED COMPLAINING OF EYES BURNING, LOSS OF SIGHT, HEADACHE, LOSS OF HEARING, LETHARGY, WEAKNESS, ETC. PROBLEMS CONTINUE TO SOME DEGREE.
PT HAD HEMODIALYSIS, THIS DIALYZER BEING USED. ONE HR AND 20 MIN INTO TREATMENT, DIALYZER HAD BLOOD LEAK AND WAS CHANGED TO ANOTHER CO'S DIALYZER, TREATMENT COMPLETED. SEVERAL HRS PT BECAME SYMPTOMATIC. C/O BURNING EYES, LOSS OF VISION, LOSS OF HEARING, HEADACHE, AND OTHER PROBLEMS.
PT UNDERGOING HEMODIALYSIS. 35 MINS INTO TREATMENT DIALYZER HAD BLOOD LEAK AND WAS CHANGED TO ANOTHER CO'S DIALYZER, TREATMENT COMPLETED. HRS LATER PT STARTED COMPLAINING OF INABILITY TO SEE, EYES BURNING, LOSS OF HEARING, HEADACHE, LETHARGY, WEAKNESS, ETC, PROBLEMS CONTINUE.
PT UNDERGOING HEMODIALYSIS. NINE MINS INTO PROCEDURE, FILTER SHOWED SMALL BLOOD LEAK AND WAS CHANGED TO ANOTHER CO'S DIALYZER AND TREATMENT COMPLETED UNEVENTFULLY. HRS LATER, PT BECAME SYMPTOMATIC, COMPLAINING OF EYES BURNING, LOSS OF VISION, HEADACHE, LOSS OF HERING, LETHARGY, WEAKNESS, ETC, PROBLEMS CONTINUE TO SOME DEGREE.
PT UNDERGOING HEMODIALYSIS. FIFTY MINS INTO THE PROCEDURE, FILTER SHOWED SMALL BLOOD LEAK AND WAS CHANGED TO ANOTHER CO'S DIALYZER AND TREATMENT COMPLETED UNEVENTFULLY. HRS LATER, PT BECAME SYMPTOMATIC, COMPLAINING OF EYES BURNING, LOSS OF VISION, HEADACHE, LOSS OF HEARING, LETHARGY, WEAKNESS AND OTHER PROBLEMS. PROBLEMS CONTINUE TO SOME DEGREE.
PT UNDERGOING HEMODIALYSIS. ONE HR INTO THE PROCEDURE, FILTER SHOWED A SMALL BLOOD LEAK AND WAS CHANGED TO ANOTHER CO'S DIALYZER AND PROCEDURE COMPLETED UNEVENTFULLY. HRS LATER, PT BECAME SYMPTOMATIC, COMPLAINING OF EYES BURNING, LOSS OF VISION, HEADACHE, LOSS OF HEARING, LETHARGY, WEAKNESS AND OTHER PROBLEMS. PROBLEMS CONTINUE TO SOME DEGREE.
PT UNDERGOING HEMODIALYSIS. TWO HRS AND 47 MINS INTO PROCEDURE, FILTER SHOWED SMALL BLOOD LEAK AND WAS CHANGED TO ANOTHER DIALYZER AND TREATMENT COMPLETED UNEVENTFULLY. HRS LATER, PT STARTED COMPLAINING OF EYES BURNING, LOSS OF SIGHT, HEADACHE, LOSS OF HEARING, LETHARGY, WEAKNESS, ETC. PROBLEMS CONTINUE TO SOME DEGREE.
WHILE RUNNING AN HIV-1 P24 ANTIGEN ASSAY, THE SAMPLER HANDLER, MISREAD A SAMPLE TUBE BARCODE LABEL. THE BARCODE WAS READ AS "053GM02304" INSTEAD OF "013GM02404". NO ERROR MESSAGE WAS GIVEN. FIELD SERVICE ENGINEER HAS BEEN DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
PUMP WAS OVERINFUSING. SYRINGE: 35CC. VOLUME: 20CC MORPHINE CONCENTRATION: 15MG/ML. THE CUSTOMER STATES THAT THE PUMP WAS SET TO DELIVER A CONTINUOUS INFUSION OVER A TIME PERIOD GREATER THAN 24 HOURS. THE NURSE CHECKED THE SYRINGE AFTER 10 HOURS AND DISCOVERED THAT THERE WAS 7CC LESS IN THE SYRINGE THAN WAS EXPECTED. THE PUMP WAS TESTED OVER 24 HOUR PERIOD WITH THE SAME RESULTS.
THE CUSTOMER HAS BEEN INSTRUCTED TO RETURN THE PUMP TO CO FOR INSPECTION AND TESTING. CO WILL SEND A FULL REPORT AFTER RECEIPT OF PUMP. THERE WERE NO OTHER OCCURRENCES OF THIS NATURE WITHIN THE PAST 12 MONTHS. CO CONSIDERS THIS TO BE A SERIOUS INCIDENT.
THE CORD EMITTED SPARKS. CO'S INSPECTION REVEALED A BREAK IN AN OLD-STYLE LINE CORD. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS ADDED A CAUTION TO THE LABELING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IF YES, THEN IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IF YES, THEN IS SEVERITY OF THIS EVENT GREATER THAN LABELED? N.
THE FIRM HAS SUBMITTED A SECOND MDR ON THE HEMODIALYSIS MACHINE INVOLVED IN INCIDENT, A 2008E MODEL, MDR NUMBER 2937457-1996-13, SUBMITTED ON 10/15/96.
THE SWITCH EMITTED SMOKE. CO'S INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROX. 1967 TO JUNE 21, 1990, CO USED SWITCH MFG BY A REPUTABLE FIRM. THE SWITCH WAS MOMENTARY TYPE SWITCH WITH A SPRING LOADED LEVER WHICH REQUIRED BEING HELD IN THE "ON" POSITION TO MAKE CONTACT. SOMETIMES A USER WOULD NOT FULLY ENGAGE THE LEVER, ALLOWING THE CONTACTS TO REMAIN SLIGHTLY OPEN WHICH COULD INDUCE ARCING. WHEN CONSISTENTLY HELD IN THIS WAY, CARBON BUILD-UP FROM THE ARCING COULD REACH OPPOSITE POLES CAUSING THE SWITCH TO EMIT A SMALL AMOUNT OF SMOKE. CO'S FIRST SOLUTION WAS TO CHANGE THE CONTACT MATERIAL AND THE BODY OF THE SWITCH. THIS REDUCED THE ARCING OF THE CONTACTS AND THE CARBON TRACKING OF THE SWITCH BODY. ALTHOUGH THE SITUATION WAS IMPROVED, THE OCCASIONAL RELEASE OF A PUFF OF SMOKE WAS POSSIBLE. ON 6/21/90, CO BEGAN USING A SNAP ACTION SWITCH WHICH DOES NOT ALLOW THE CONTACTS TO BE HELD IN A SLIGHTLY OPEN POSITION. THIS EVENT IS NOT REPORTABLE UNDER 21CFR803 BECAUSE SIMILAR EVENTS WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEAT OR A SERIOUS INJURY. THIS REPORT IS BEING MADE TO BE COMPLIANT WITH REGULATORY LETTER 90-DT-12. REMEDIAL ACTION HAS BEEN ACCOMPLISHED.
FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IF YES, THEN IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IF YES THEN IS SEVERITY OF THIS EVENT GREATER THAN LABELED? N.
BIOMEDICAL ENGINEER REPORTED THAT THE CHANNEL 2 VERNIER WAS NOT OPERATING PROPERLY CH2 OUTPUT WAS MOVED TO CHANNEL 3. THE PT THEN "WENT INTO FIBRILLATION." CHANNEL 3 WAS OUTPUTTING SPORADIC PULSES. SUBSEQUENT CONVERSATION WITH THE CATH LAB INDICATED THAT THE PT DID NOT GO INTO FIBRILLATION. THERE WAS NO REPORTED INJURY TO THE PT. CO IS CONTINUING TO INVESTIGATE THE REPORTED EVENT.
ANALYSIS: NO OUTPUT CAHNNEL 2 (OR ANY CHANNEL) COULD BE CAUSED BY A FAILURE IN DTU PULSE GENERATOR, PT ISOLATOR, OR INTERCONNECTING CABLE. THERE WAS DAMAGE TO INTERCONNECTING CABLE, BUT IT WAS NOT DEMONSTRATED THAT THIS COULD CAUSE ORIGINAL FAILURE. THERE WAS NO EVIDENCE OF PULSE GENERATOR FAILURE. BATTERIES ARE ONLY POWER SOURCE FOR PT ISOLATORS. IT IS LIKELY THAT DEAD BATTERIS ON CHANNEL 1 AND 2 ARE ROOT CAUSE FOR NO OUTPUT. INTERMITTENT OUTPUT ON CHANNEL 3 COULD ALSO BE CAUSED BY FAILURES IN PULSE GENERATOR, PT ISOLATOR, OR CABLE. BAD BATTERY CLIP CONNECTION AND LOOSE BATTERY POST ARE PROBABLE CAUSE OF INTERMITTENT OR SPORADIC OUTPUT. MOST PROBALBE IS LOOSE BATTERY POST (PART OF THE BATTERY) WHICH WAS ACTUALLY SEPARATED FROM BATTERY AND HELD ONLY BY HOUSING AT END OF BATTERY. BATTERY WAS NOT A BRAND USED BY FISCHER AND WAS PURCHASED AND INSTALLED BY USER. DAMAGED CABLE COULD HAVE CAUSED INTERMITTENT OUTPUT, BUT THIS MECHANISM WAS NOT DUPLICATED DURING TESTING. OTHER ITEMS DID NOT CONTRIBUTE TO FAILURE BUT INDICATE THAT UNIT PROBABLY WAS NOT MAINTAINED AS WELL AS IT COULD HAVE. CONCLUSION: THE FAILURE DESCRIBED BY USER AS NO OUTPUT ON CHANNEL 2 WAS PROBABLY CAUSED BY A DEAD BATTERY IN CHANNEL 2 PT ISOLATOR. FAILURE DESCRIBED BY USER AS "SPORADIC" OUTPUT ON CHANNEL 3 WAS PROBABLY CAUSED BY A BROKEN BATTERY CLIP ON CHANNEL 3 PT ISOLATOR. BATTERY HARNESS WIRE WAS NOT SUFFICIENTLY LOOSE TO CAUSE LOSS OF CONTACT WITH CONNECTOR.
AFTER SEVERAL ATTEMPTS TO OBTAIN INFO ABOUT THIS INCIDENT, THE FACILITY DID NOT RETURN CO'S CALLS ON 10/7/96. THE FACILITY REPORTED THAT THE MACHINE HAD BEEN PROGRAMMED TO REMOVE. THE LAST 20 MINUTES OF THE TREATMENT THE PT BECAME HYPOTENSIVE, REFUSED NORMAL SALINE AND WAS GIVEN BROTH INSTEAD. THE PT'S SYMPTOMS SUBSIDED AND THE TREATMENT WAS CONTINUED. THE MACHINE WAS REMOVED FROM THE TREATMENT AREA FOR INVESTIGATION. THE MFR REP WAS NOT ABLE TO DUPLICATE THE DESCRIBED EVENT OR DISCOVER ANY CONTRIBUTING FACTOR THAT WOULD CAUSE OR CONTRIBUTE TO THE DESCRIBED EVENT. SOME MINOR RECALIBRATION WAS PERFORMED AND PROPER MACHINE OPERATION WAS VERIFIED. THE FACILITY STATES THE MACHINE HAS BEEN OPERATING WITHOUT ANY PROBLEMS.
BLOCK F COMPLETED BY MFR. THE RECALIBRATION PERFORMED ON THE MACHINE AFTER EVAL WOULD NOT BE A CONTRIBUTING FACTOR IN THE DESCRIBED EVENT. CAUSE OF THE EVENT IS UNKNOWN.
WHILE INSERTING CATHETER IN R ANTECUBITAL SPACE, FELT RESISTANCE. TRIED TO REPOSITION NEEDLE; CONTINUED RESISTANCE. WITHDREW NEEDLE. TEFLON, COVERING NEEDLE, WAS SPLIT. APPROX 1/16 OF INCH OF TEFLON WAS AT RIGHT ANGLE TO STEEL NEEDLE. EXPIRATION DATE 2/00.
CONSUMER USED THE SWAB IN THE EAR CANAL AFTER SHOWERING. SHE ALLEGES THAT THE SWAB BROKE AND COTTON DID NOT COME OUT OF HER EAR. CONSUMER SAW ENT 10/7/96 AND HAD AN AUDIOGRAM AND TYMPANOGRAM.
CONSUMER DOES NOT REPORT ANY MEDICAL CONSEQUENCES. DEVICE HAS CAUTION IN LABELING INFO, CONSUMER NOT TO USE IN THE EAR CANAL. NO CONCLUSION CAN BE DRAWN; USER ERROR CONTRIBUTED TO EVENT. NO SAMPLE IS AVAILABLE FOR EVAL. THE DATE CODE DID NOT INCLUDE THE MACHINE IDENTIFICATION, THEREFORE, ALL 8228 BATCH RECORDS AND MAINTENANCE LOGS WERE REVIEWED. THE BATCH RECORD INDICATED THAT MACHINE K HAD PROBLEMS WITH BREAKING HEADS. NO OTHER PROBLEMS RECORDED . A RETAIN FOR THIS DATE CODE AND SKU WAS FROM MACHINE C THE RETAIN WAS TESTED. AND HAD THE CORRECT NUMBER OF SERRATIONS FOR EACH SIDE OF THE SWAB. A TEAM HAS BEEN WORKING TO IDENTIFY THE FAILURE MODES THAT MAY CAUSE A COTTON BUD TO COME OFF. CAUSES IDENTIFIED HAVE BEEN CORRECTED THROUGH INCREASED OPERATOR AWARENESS AND MACHINE ADJUSTMENTS.
1. TEMPERATURE PROBE TIP COMES IN DIRECT CONTACT WITH PT SKIN. PREMATURE BABIES HAVE EXTREMELY FRAGILE SKIN. 4 REPORTS OF SKIN ABRASIONS RECEIVED. 2. PROBE INTACT TO PT SKIN, MEASURING ERRONEOUS TEMPERATURES. INCUBATOR INCREASED HEAT OUTPUT - BABY WARMED TO 100 DEGREE F AXILLARY. 3. 3 REPORTS OF PROBE NOT MEASURING. ANY PT TEMP RESULTING IN INCREASED HEAT OUTPUT BY INCUBATOR. PROBE WIRE WAS "WIGGLED" AND THE PROBE THEN FUNCTIONED. (PROBES WERE OF COURSE REPLACED). PROBES ALSO LOOK DIFFERENT IN CONSTRUCTION FROM OTHER PROBES AS THEY ARE MISSING A PLASTIC SUPPORT AT THE CONNECTION OF THE WIRE TO THE PLUG. IN EACH CASE THE PROBE WAS USED IN CONJUNCTION WITH THE APPROPRIATE CABLE AS SUPPLIED BY THE VENDOR. THE FOURTH PROBE WAS NOTED TO HAVE A CRACKED TIP WHEN REMOVED FROM THE PT.
PT WAS RECEIVING A PHOTOTHERAPY TREATMENT FOR ECZEMA. PT HAD HER HANDS INSIDE THE MACHINE, WHICH WAS SET BY A MEDICAL ASSISTANT TO DELIVER 2.5 JOULES OF ULTRAVIOLET RADIATION. THE MACHINE DID NOT TURN OFF AUTOMATICALLY AFTER THE 2.5 JOULES WAS DELIVERED. THE MEDICAL ASSISTANT CAME IN TO CHECK ON THE PT APPROX ONE MIN AFTER THE MACHINE SHOULD HAVE TURNED OFF AND HAD THE PT REMOVE HER HANDS. TWO DAYS FOLLOWING THIS INCIDENT, THE PT DEVELOPED REDNESS AND BLISTERING ON HER HANDS. IN EXAMINING THE MACHINE AFTER THE PT LEFT, IT APPEARS THE MACHINE'S INTERNAL COUNTING DEVICE FOR MEASURING HOW MANY JOULES OF ENERGY IT IS DELIVERING WAS NOT ADVANCING.
DURING A PROCEDURE WITH ANOTHER CO'S SYSTEM, POWER WAS LOST IN THE ROOM THEREBY DISABLING THE UNIT. THE TECHNOLOGIST CLAIMS THAT AFTER THE POWER WAS LOST THE UNIT'S C-ARM WAS ALLOWED TO DRIFT (X-Y MOVEMENT) AND THAT THERE WERE MINIMAL PROBLEMS BECAUSE THE PROCEDURE WAS BASICALLY OVER. THERE WAS NO PT INJURY.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING? NO. IS SEVERITY OF OCCURRENCE OF EVENT ADDRESSED IN DEVICE LABELING? NO. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? UNK. AN ADD'L UNINTERUPPTED POWER SUPPLY (UPS) IS NOW BEING USED BY THE HOSP AFTER THE RECOMMENDATION OF THE DEALER, IMAGING.
THE MCL20 WAS USED DURING A LOW ANTERIOR RESECTION. THE CLIPS WERE SLIPPING OUT OF THE JAWS OF THE DEVICE AS THE SURGEON ATTEMPTED TO CLIP. MANY OF THE CLIPS CROSSED AT THE DISTAL END AND MANY DID NOT CLOSE COMPLETELY. SURGEON EXPRESSED DISSATISFACTION. THE SURGEON USES THE DEVICE TO ALSO DISSECT THE TISSUE AND THE CLIPS FALL OUT AS THIS IS DONE. REP IS ALSO RETURNING SOME CLIPS. THE SURGEON REMOVED THE CLIPS FROM THE ABDOMEN. THE CASE WAS COMPLETED WITH A MCL20. THERE WAS NO CONSEQUENCE TO THE PT.
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
RESIDENT WAS BEING TRANSPORTED TO A DR APPOINTMENT BY THE FACILITY VAN. RESIDENT WAS SEAT BELTED INTO A W/C AND W/C WAS SECURED TO THE VAN FLOOR. THE VAN CAME TO A STOP AT AN INTERSECTION AND RESIDENT FELL FORWARD OUT OF W/C AND HIT HER FACE ON DOOR HANDLE. RESIDENT HAD 4 INCHES OF STITCHES ON FACE. POSSIBLE FRACTURE OF L FEMORAL NECK. POSSIBLE FRACTURE OF PROXIMAL TIB AND FIB.
FIREFIGHTERS WERE TREATING A PT (AGE AND GENDER UNK) AND AN "ECG LEAD OFF" MESSAGE APPEARED ON THE UNIT'S MONITOR SCREEN. THERE IS NO INDICATION OF ANY ADVERSE EFFECT ON THE PT. THE COMPLAINANT HAS BEEN UNABLE TO PROVIDE FURTHER INFORMATION.
PRESSURE WOULD NOT COME DOWN FROM 110 TO 130.
PRODUCT WAS EVALUATED BY CO FOR PATENCY, SIPHONING, PRESSURE/FLOW CHARACTERISTICS AND PREIMPLANTATION PRESSURE. THE PRODUCT MET CO SPECIFICATIONS FOR PATENCY, SIPHONING AND PREIMPLANTATION PRESSURE, BUT TESTED 0.5 CM HIGH WHEN TESTED FOR PRESSURE/FLOW CHARACTERISCTICS AT 5.0 ML/HR (-50 CM HP). CO WAS UNABLE TO DETERMINE THE CAUSE OF THE FAILURE OF THE DEVICE TO MEET THIS SPECIFICATION.
THE CUSTOMER ALLEGED THAT THERE WAS NO AUDIO ALARM WHILE THE VENTILATOR WAS IN APNEA. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF TESTING. NO PARTS WERE REPLACED FOR THE NO AUDIO ALARM CONDITION. IT IS NOT VERIFIED THAT THE AUDIO ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
ONE RESIDENT HAD 2 FALLS FACE FORWARD OUT OF THE "GO CHAIR" WITH LAP TRAY IN PLACE. TRAY LOOSENS AND SEPARATES ALLOWING RESIDENT TO FALL FORWARD. IT APPEARS THAT THERE IS A MECHANICAL FLAW. THE CHAIR IS NO LONGER USED.
DURING A CODE A STAFF MEMBER OBTAINED A RESUSCITATOR FROM A 'CRASH' CART FOR USE AND OBSERVED MASK MISSING FROM POLYBAG. ANOTHER RESUSCITATOR WAS OBTAINED FROM 'CRASH' CART AND PT WAS RESUSCITATED. NO REPORTED HARM TO PT.
THE CUSTOMER ALLEGED THE AUDIO ALARM WAS NONFUNCTIONAL. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND REPLACED THE DISPLAY PCBA. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE AUDIO ALARM WAS OUT OF SPEC, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
A STENT WAS DEPLOYED IN THE PT, BUT THE DR COULD NOT GET A HIGH PRESSURE BALLOON ACROSS THE STENT TO POST DILATE. A PTCA CATHETER WAS USED DUE TO ITS LOW CROSSING PROFILE. THE CATHETER WAS ADVANCED INTO THE STENT AND INFLATED, BUT WAS UNABLE TO BE WITHDRAWN, PRESUMABLY FROM THE STENT. ADD'L FORCE WAS USED TO REMOVE THE BALLOON, AND THE DISTAL TIP BROKE OFF IN THE PT. UPON REMOVAL IT WAS NOTED THAT THE BALLOON BROKE AT THE PROXIMAL CONE, AND THE INNER LUMEN BROKE JUST DISTAL TO THE MIDMARKER. NO PT COMPLICATIONS WERE NOTED AND NO ADD'L INTERVENTIONAL WAS PERFORMED. NO ADD'L DETAILS WERE PROVIDED AFTER NUMEROUS ATTEMPTS.
THE DEVICE WAS NOT RELEASED BY THE HOSP FOR EVAL. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED BY THE RPTR. DESPITE ATTEMPTS TO OBTAIN SUCH INFO FROM THE RPTR, CO IS UNABLE TO PROVIDE COMPLETE INFO REQUIRED ON FORM 3500A.
THE SVC REPORT SHOWS THAT THE DEVICE FAILED THE LEAK TEST DURING PERFORMANCE OF AN INCOMING EVAL. THE SVC TECHNICIAN INSPECTED THE DEVICE AND ADJUSTED THE PISTON GUIDES. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
RESPIRATORY THERAPIST REPORTED, A PT WAS REMOVED FROM VENTILATOR. A RESUSCITATOR BAG WAS USED TO GIVE PT THREE BREATHS, NO PT RESPONSE. PUT PT BACK ON VENTILATOR. NO REPORTED HARM TO PT.
THE VALVE WAS HOOKED TO THE MANOMETER. THE MANOMETER PRESSURE DID NOT LIKE IT WAS SUPPOSED TO.
THE RETURNED PRODUCT WAS EVALUATED BY CO FOR PREIMPLANATAION PRESSURE, PRESSURE/FLOW CHARACTERISTICS, PATENCY AND SIPHONING. A PARTICLE WAS FOUND IN THE SEAT AREA OF THE LOWER SIPHON CONTROL MEMBRANE OF THE VALVE. WHEN TESTED, THE PARTICLE FLUSHED OUT DURING INITIAL PRIMING AND HAD NO EFFECT ON THE PERFORMANCE OF THE VALVE. THE PRODUCT MET ALL CO'S PERFORMANCE SPECIFICATIONS. THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED AND NO ANOMALIES WERE NOTED.
CATHETER WAS IMPLANTED ON 12/7/95 FOR VENOUS ACCESS. ON 8/13/96, PT DEVELOPED PAIN WHEN CATHETER WAS BEING FLUSHED IN CLAVICULAR AREA. FLUOROSCOPIC INJECTION SHOWED CATHETER TO BE LEAKING IN SUBCLAVIAN AREA. THIS NECESSITATED REMOVAL OF FAULTY CATHETER WITH REPLACEMENT FOR CONTINUED MEDICATION THERAPY. PHYSICIAN HAS REQUESTED SMDA REPORTING.
THE CUSTOMER REPORTED THAT THE UNIT'S AUDIBLE ALARM WAS TOO LOW TO HEAR. THE SVC TECHNICIAN VERIFIED THE LOW ALARM VOLUME. THE ST INSPECTED THE DEVICE AND ADJUSTED THE ALARM CONTROL CIRCUIT. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFORMATION IN CO'S POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE FLOW CHANGED DURING THE MIDDLE OF A CASE. THE UNIT WAS CHANGED OUT WITH ANOTHER DEVICE. THE PT WAS NOT AFFECTED.
HOSP DID NOT FILE A REPORT FOR THIS MALFUNCTION. THE INFO IN SECTIONS A,B,C,D,E, AND F WAS OBTAINED FROM THE INITIAL COMPLAINT. NO OTHER INFO IS AVAILABLE. PROBLEM VERIFIED; FLOW DISPLAY CHANGES WHEN AREA II PANEL IS MOVED. NO OTHER VISUAL OR FUNCTIONAL PROBLEMS NOTED. INTERNAL INSPECTION OK. REPLACED THE ZERO POT AND GAIN POT ASSEMBLIES TO RESOLVE THE PROBLEM. CONSOLE WAS INSPECTED. CALIBRATION WAS CHECKED AND FINAL TEST WAS PERFORMED. CONSOLE MEETS MFR'S SPECIFICATIONS.
THE SVC REPORT SHOWS THAT THE LEAK TEST WAS OUT OF SPEC WHILE PERFORMING AN INCOMING EVAL. THE CO SVC TECHNICIAN INSPECTED THE DEVICE AND ADJUSTED THE SAFETY VALVE SPRING. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE SVC REPORT SHOWS THAT THE LEAK TEST WAS OUT OF SPEC WHILE PERFORMING AN INCOMING EVAL. THE CO SVC TECHNICIAN INSPECTED THE DEVICE AND REPLACED THE INLET VALVE LEAF. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE SVC REPORT SHOWS THAT THE VOLUMES WERE OUT OF SPEC WHILE PERFORMING AN INCOMING EVAL. THE SVC TECHNICIAN INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
CODE 000: CUP SEAL. BASED UPON INFO IN CO'S POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION OF THE PROSTHESIS THROUGH THE DISTAL ASPECT OF THE RIGHT CORPORAL BODY WITH DRAINAGE OF PUS, SWELLING OF THE GENITALIA AND PAIN. ADD'L LOT/SER NO: BH527 007.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT AND REPLACED REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS-CYLINDER.
CYLINDER REQUIRED EXCESS PUMPS TO INFLATE. CYLINDER HAD A WEAR LEAK.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. TUBING HAD A WEAR LEAK. TUBING HAD A FATIGUE AND WEAR LEAK.
THE SCREW HOLE TAP INSTRUMENT BROKE DURING A SPINE SURGERY. THE EVENT LED TO A PROLONGED SURGERY AND CAUSED THE SURGEON TO ACCIDENTALLY TEAR THE DURA OF THE SPINAL CORD. NO OTHER INFO WAS PROVIDED TO CO.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED BECAUSE IT WAS "DEFECTIVE".
THE RIGHT CYLINDER WAS REMOVED FROM THE PT, BECAUSE IT WOULD NOT INFLATE OR DEFLATE PROPERLY, AND REPLACED.
THE BEARING INSERT COMPONENT OF THE TIBIAL PROSTHESIS BROKE IN HALF. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES. D.6.-THE EXACT SIZE OF THE DEVICE IS UNK BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED. H.4.-THE DATE OF MFR IS UNK BECAUSE THE MANUFACTURING LOT NUMBER WAS NOT PROVIDED.
DEVICE WAS IMPLANTED IN 1986. THE PUMP WAS REMOVED ON 10/25/94. INFO ACQUIRED ON 10/7/96 INDICATES THE REST OF THE DEVICE WAS REMOVED FROM THE PT ON 12/20/94 DUE TO EROSION. UNABLE TO OBTAIN ADD'L INFO.
PT WAS PUT TO SLEEP UNDER GENERAL ANESTHESIA FOR EMERGENCY C-SECTION FOR FETAL DISTRESS. AFTER SURGERY, DRAPE WAS PULLED OFF AND A CAUTERY BURN WAS NOTED ON UPPER LEFT QUADRANT. WHILE STILL UNDER GENERAL ANESTHESIA, BURNED AREA WAS EXCISED AND SUTURED. BOVIE SENT TO BIOMED FOR TESTING. DEVICE HEATING OKAY.
THE CUSTOMER SENT A MEDWATCH REPORT THAT INDICATED "THE PT WAS PUT TO SLEEP UNDER GENERAL ANESHTHESIA FOR EMERGEQNCY C-SECTION FOR FETAL DISTRESS; AFTER SURGERY, THE DRAPE WAS PULLED OFF AND A CAUTERY BURN WAS NOTED ON THE UPPER LEFT QUADRANT. WHILE STILL UNDER GENERAL ANESTHESIA, THE BURNED AREA WAS EXCISED AND SUTURED. THE BOVIE WAS ASENT TI BIOMED FOR TESTING; RESULTS BACK ON 9/23/96; DEVICE HEATING O.K.
THE BEARING INSERT COMPONENT OF THE HIP ACETABULUM PROSTHESIS WORE THROUGH AND CRACKED, NECESSITATING ITS REMOVAL. NO OTHER INFO WAS PROVIDED TO CO.
ADDITIONAL INFORMATION RECEIVED ON 1/24/97 INDICATES AUTO-INFLATION.
A 3 YEAR OLD WITH COMPLEX CONGENITAL CARDIAC ARREST UNDERWENT A FONTAN PROCEDURE ON 7/15/96. DEVELOPED RENAL FAILURE S/P SURGERY AND REQUIRED CVVH. STAFF EXPERIENCED INTERMITTENT OCCLUSION OF THE CATHETER WITH NO OBVIOUS EVIDENCE OF A DEFECT. A CATHETER DISCARDED WHEN REMOVED. CVVH DISCONTINUED DUE TO FREQUENT ALARMING WITH CHILD EXPIRING SEVERAL HOURS AFTER THERAPY DISCONTINUED. VENTRICULAR DYSRHYTHMIAS WERE REFRACTORY TO TREATMENT. THIS IS BEING REPORTED ONLY AS A PRECAUTIONARY MATTER.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-HOLE IN CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING HAD OR DAMAGE.
THE POLYETHYLENE INSERT COMPONENT OF THE ACETABULUM PROSTHESIS WORE THROUGH AND NEEDED TO BE REPLACED. NO OTHER INFO WAS PROVIDED TO CO.
INFO RECEIVED ON 10/7/96 INDICATES THE PUMP WAS REMOVED FROM THE PT DUE TO EROSION. UNABLE TO OBTAIN ADD'L INFO.
ON 10/16/96 ADD'L INFO PROVIDED BY THE HOSP REVEALED THAT THE VENTRICULAR DISRHYTHMIA WAS ASSOCIATED TO THE PT'S COMPLEX CONGENITAL CARDIAC DISEASE AND DID NOT RESPOND TO "MEDICAL" TREATMENT. BASED ON THIS INFO , THE PT'S DEATH WAS NOT CATHETER RELATED BUT WAS THE RESULT OF A PRE-EXISTING CONDITION (PREVIOUS CARDIAC HISTORY.)
THE PIN AND CLIP LOCKING MECHANISM THAT SECURES THE POLYETHYLENE INSERT COMPONENT TO THE TIBIAL PROSTHESIS WOULD NOT ENGAGE. A SEPARATE PIN AND CLIP HAD TO BE UTILIZED. NO OTHER INFO WAS PROVIDED TO CO.
DEVICE WAS REMOVED FROM THE PT DUE TO AN ANEURYSM. ADD'L LOT/SER NO: 5007M 021.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CYLINDER HAD TORN FABRIC AND BULGING. TUBING HAD OR DAMAGE.
OVERHEAD FRAME OF THE TRAPEZE SHIFTED AND FELL ON PT.
ON 2/26/92 AN AUS DEVICE WAS IMPLANTED. ON 10/26/94 THE CUFF WAS REVISED. ON 9/4/96 THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION-CUFF PT E.R. CATHETERIZED.
THE CUFF WAS REMOVED FROM THE PT DUE TO EROSION-CUFF, CATHETER PLACEMENT.
THE DISPOSABLE LOADING UNIT WAS USED WITH A STAINLESS STEEL INSTRUMENT DURING A LOBECTOMY. REPORTEDLY, THE INSTRUMENT WAS FIRED, HOWEVER NO STAPLES WERE PLACED. THE SURGEON USED ANOTHER INSTRUMENT TO ACHIEVE HEMOSTASIS AND RESECTED AN INCH OF THE LUNG LOBE.
1/14/97- SUPPLEMENTAL REPORT #1 SENT TO FDA. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL.
RECEIVED CALL FROM DISCHARGE COORDINATOR REGARDING HOSP ER ADMISSION OF PT. UPON ADMISSION TO ER, PT'S PUPILS WERE FIXED AND DILATED; PT WAS UNRESPONSIVE AND APPARENTLY HAD HAD A SEIZURE. PER HISTORY, PT IS APPROX 5 MONTHS OLD MALE, CONTINUOUS VENTILATOR DEPENDENT. PER MD ORDERS: SETTINGS OF VOLUME .600, RATE 28 BPM, INSPIRATORY TIME .6 FIO2 AT 21%. PT HAS APNEA MONITOR UNDER SETTINGS OF TACHYCARDIA OFF, BRADYCARDIA AT 80 BPM, APNEA DELAY OF .20 SECS. PT ALSO HAD LOW PRESSURE ALARM WITH SETTINGS OF LOW PRESSURE ALARM AT 24CM H2O WITH 10 SECS DELAY. PT HAD 2 SUCTION MACHINES 1 STANDARD, 1 PORTABLE. PT WAS RECEIVING MEDICATION NEBULIZER TREATMENTS OF: GENTAMYCIN B.I.D. ALBUTEROL AND SALINE FOR 8 HRS. ALBUTEROL AND INTAL FOR 8 HRS. PT HAD 2 AMBU BAGS. PT HAD E SYSTEM OF 1 TO 5 LMP IN CASE OF EMERGENCY. PT HAD LIQUID O2 AT HOME, NOT IN USE, DUE TO THE FACT THAT PT HAD BEEN WEANED FROM O2 PREVIOUS TO DISCHARGE FROM HOSP. VENT ON STROLLER HAD BATTERY (EXTERNAL) PT HAD NEW TRACH BECAUSE OF POSS. DECANNULATION EARLIER THAT DAY. DISCHARGE COORDINATOR REQUESTED FOR RPTR TO GO TO THE HOME PICK UP MONITOR TO DOWNLOAD WITH CHECK VENT SETTINGS. WHEN RPTR ARRIVED AT THE HOME, BOTH PARENTS WERE UPSET. RPTR REQUESTED THAT FATHER VIDEO TAPE VISIT. RPTR PICKED UP APNEA MONITOR AND DOWNLOADED AT OFFICE. WHILE AT PT'S HOME RPTR REVIEWED VENT SETTINGS AND FOUND THAT RATE WAS CHANGED TO 26 AND INSPIRATORY TIME WAS AT .9. RPTR DID NOT CHECK VENT PERFORMANCE. PARENTS REVIEWED SETTINGS WITH RPTR. DAD STATED THAT AFTER PARAMEDICS LEFT THE HOME HEALTH NURSE SAID THAT HE COULD CHANGE THE VENT SETTINGS BACK TO WHAT THEY ORIGINALLY WERE. ALSO DAD SAID THAT THE NURSE CHARTED TIMING A SEIZURE FOR 11 MINS AT TIME OF INCIDENT WITHOUT CALLING FOR HELP. THE TUBING FOR THE AMBU-BAG WAS CONNECTED TO THE REGULATOR'S "T" SCREW USED TO TIGHTEN REGULATOR. PARENTS SAID THE NURSE DID THAT AND NURSE DIDN'T KNOW HOW TO USE E SYSTEM. ALSO THE PARENTS SAID THEY CAUGHT THE NURSE SLEEPING JUST PRIOR TO INCIDENT AND WOKE HER UP. MOM TOLD RPTR THAT THE DAY BEFORE SHE TAUGHT THE NURSE HOW TO TURN OFF THE APNEA MONITOR. MOM ALSO SAID NURSE DIDN'T KNOW HOW TO TURN OFF LOW PRESSURE ALARM. MOTHER TOLD RPTR THAT SHE HAD A PROBLEM WITH THE NIGHT NURSE. ON 10/1/96 RPTR CALLED PARENTS TO PICK UP VENT TO BE SENT TO MFR. FATHER OF PT REFUSED AND TOLD RPTR TO CALL HIS LAWYER TO GET THE OK. DISCHARGE COORDINATOR AT CHCA. SHE SAID TO HOLD OFF AND DON'T WORRY ABOUT IT. ALL OF THE EQUIPMENT EXCEPT THE APNEA MONITOR IS STILL AT PT HOME.
INFO ACQUIRED ON 10/11/96 INDICATES THE CUFF WAS REMOVED FROM THE PT IN 6/96, DAY NOT INDICATED. THE REASON FOR REMOVAL OF EROSION.
THE DEVICE WAS USED DURING A CARTOID ENDOARTERECTOMY PROCEDURE. REPORTEDLY, THE SUTURED INCISION OPENED. THE SURGEON PERFORMED A REOPERATION TO RESUTURE THE WOUND. THE HOSPITAL HAS REPORTED THAT THE PT'S STATUS IS GOOD.
10/25/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
AN AUS DEVICE WAS IMPLANTED ON 8/31/83. THE CUFF WAS REVISED ON 11/9/83. THE OUMO WAS REVISED ON 8/15/84. THE PUMP AND BALLOON WERE REVISED ON 3/6/85. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 9/23/96 DUE TO FLUID LOSS.
PUMP PERFORMED WITHIN SPECIFICATIONS. CUFF HAD A WEAR LEAK. BALLOON HAD OR DAMAGE.
THIS REPORT WAS ORIGINALLY RECEIVED ON 27 SEP 1996. ADDITIONAL INFO WAS RECEIVED ON 28 OCT 1996. THE LENS INFO SUPPLIED IN TEH INTIAL MDR WAS A DIFFERENT LENS THAN THIS REPORT. THE RETURNED LENS MATCHED THE ORIGINAL MDR SUBMISSION. A QUESTIONNAIRE RETURNED FROM THE MDR REVEALED A DIFFERENT LENS WAS INVOLVED IN THIS EVENT AND THIS INFO IS SUPPLIED IN SECTION D. THE MFR HAS CONFIRMED THAT 2 LENSES WERE RETURNED FROM THIS MDR FOR 2 DIFFERENT COMPLAINTS. ADDITIONAL INFO IS BEING SOUGHT TO CLARIFY WHICH LENS WAS INVOLVED IN THIS PATIENT INJURY COMPLAINT. AS MENTIONED IN THE PREVIOUS SUPPLEMENTAL REPORT ADD'L INFO WAS SOUGHT TO CLARIFY WHICH LENS WAS INVOLVED IN THIS INCIDENT. IT WAS DETERMINED BY THE MFR THAT THE LENS SUBMITTED IN THE PREVIOUSLY FILED SUPPLEMENTAL REPORT WAS THE LENS INVOLVED IN THIS INCIDENT. THE INITIALLY REPORTED LENS WAS DETERMINED TO HAVE BEEN REPORTED TO THE MFR AS A MALFUNCTION WITH NO PT INJURY.  THIS REPORT WAS MAILED IN TO FDA ON: 12/13/1996.
SURGEON REPORTS "PATIENT IS OBESE AND HAD IRIDORETICULAR ADHESIONS RELATED TO LASER TRABECULOPLASTY. ON PLACING THE LENS A RUPTURE OF THE POSTERIOR CAPSULE OCCURRED. THE LENS WAS REMOVED (THE HAPTIC BROKE AT THAT TIME) AND A POSTERIOR CHAMBER PMMA LENS WAS PLACED IN THE SULCUS AFTER LIMITED ANTERIOR VITRECTOMY. ADDITIONAL VISCOELASTIC AT THE TIME OF LENS PLACEMENT MAY HAVE AVERTED THE PROBLEM." IN ADDITION SURGEON REPORTS MILD MACULAR EDEMA WHICH IS STILL UNDER TREATMENT AND A CURRENT VISUAL ACUITY OF 20/30.
RESPIRATORY THERAPIST WAS FILLING THE HUMIDIFICATION CHAMBER ON THE VENTILATOR, USING A STERILE WATER BAG WITH MICRODRIP PIGGYBACK TUBING CONNECTED INTO THE CHAMBER. THE TUBING WAS LEFT UNCLAMPED. SUBSEQUENTLY, THE CHAMBER AND THE CONNECTED TUBING FILLED WITH WATER AND BACKED UP INTO THE PT'S TRACHEOSTOMY. THE PT BECAME CYANOTIC AND BRADYCARDIC. IMMEDIATE INTERVENTIONS WERE TAKEN. THE PT RESPONDED WITHOUT ADVERSE EFFECT OR SERIOUS INJURY.
ALLEGED INFECTION. FOLLOW-UP FINDINGS: AS PER PHYSICIAN ETIOLOGY UNKNOWN.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER CFR, PART 803.16, THIS REPORT AND INFORMATION DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFORMATION CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR IT'S EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. EVAL OF THE RETURNED DEVICE NOTED IT TO BE INTACT AND FUNCTIONAL. THE ALLEGED EVENT OF INFECTION IS NOT INDICATIVE OF DEVICE FAILURE. THE POTENTIAL FOR INFECTION TO OCCUR IS ADDRESSED IN THE LABELING AND IS THEREFORE NOT AN UNANTICIPATED EVENT. THE CAUSE OF THIS PHYSIOLOGICAL RESPONSE OR SURGICAL COMPLICATION IS NOT KNOWN AND CANNOT BE DETERMINED.
THE DEVICE WAS APPLIED DURING A VATS PROCEDURE. REPORTEDLY, THE INSTRUMENT CUT AND DID NOT STAPLE. THE SURGEON RESECTED TISSUE AND COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSPITAL HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
11/22/96- SUPPLEMENT REPORT #1 SUBMITTED TO FDA. ADD'L DATA ENTERED IN D9. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6.
THE SVC REPORT SHOWS THAT THE VOLUMES WERE OUT OF SPEC WHILE PERFORMING AN INCOMING EVAL. THE CO SVC TECHNICIAN INSPECTED THE DEVICE AND REPLACED THE CONICAL SPRING. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
ADD'L NARRATIVE: CODE 000: CONICAL SPRING. BASED UPON INFO IN CO'S POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE PT WAS IMPLANTED WITH THE DEVICE ON 10/22/91. ON 7/1/96 THE PHYSICIAN NOTED SILICONOMA IN THE PT'S LEFT BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. CO EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSABLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION ".
THE DEVICE WAS USED DURING A TUBAL LIGATION PROCEDURE. REPORTEDLY, THE INSTRUMENT PUNCTURED A FALLOPIAN TUBE. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE TO CONTROL THE BLEEDING.
10/25/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. THE SURGEON STATED THE DISTAL END OF THE INSTRUMENT COULD NOT BE VISUALIZED DURING APPLICATION.
THE CATHETER WAS PLACED ON 8/5/96, AND REMOVED ON AN UNK DATE. ON 9/23/96, AN APPROXIMATELY 1' SECTION OF WHAT IS BELIEVED TO BE A PORTION OF UNRAVELLED GUIDEWIRE WAS SNARED FROM THE PT'S PULMONARY ARTERY.
PRODUCT IMPLICATED IS A CATHETER WITH GUIDEWIRE. RETURND FOR EVALUATION IS A 40.4CM SECTION OF COILED SPRING WIRE. LOT HISTORY REVIEW WAS NOT POSSIBLE SINCE NO LOT NUMBER WAS INDICATED. THE SECTION OF COILED SPRING WIRE DOES NOT INCLUDE A PROXIMAL OR DISTAL WELD, APPROXIMATELY 31.1CM OF SPRING WIRE IS MISSING AND NO CORE WIRE IS PRESENT. UNDER 50X MAGNIFICATION, ONE TIP OF THE WIRE IS COMPACTED, WITH SMALL SCRAPE MARKS ALONG THE EDGE OF THE WIRE, WHILE THE OPPOSITE END OF THE WIRE IS SLIGHTLY ELONGATED. IT APPEARS ONE END OF THE WIRE MAY HAVE BEEN CUT, WHILE THE OTHER END SHOWS SIGNS OF A TENSILE BREAK. THIS COULD OCCUR IF THE CLINICIAN CUT THE GUIDEWIRE PRIOR TO INSERTION. UPON WITHDRAWAL OF THE WIRE AFTER INSERTION, THE SPRING WIRE BROKE, LEAVING A SECTION OF WIRE INSIDE THE CATHETER WHICH SUBSEQUENTLY MIGRATED. THE COMPLAINT IS CONFIRMED AND SHOULD BE RECORDED AS USER RELATED, DUE TO MISUSE.
RESIDENT TRANSFERRED TO HOSP DUE TO "BREATHING DIFFICULTY, RESPIRATIONS 40/MIN LABORED, BP 160/90, PULSE 50/MIN." ADMITTED WITH A DIAGNOSIS OF 2ND-3RD DEGREE HEART BLOCK: PACEMAKER FAILURE TO CAPTURE. THE PACEMAKER WAS INSERTED ON 9/15/96. PT AND FAMILY REQUEST NO FURTHER INTERVENTION SECONDARY TO PT'S POOR QUALITY OF LIFE. THE INFO ABOUT THE BRAND AND TYPE OF PACEMAKER WAS OBTAINED FROM THE DISCHARGE SUMMARY. EVALUATION OF THE PT AND THE PACEMAKER WAS COMPLETED AT HOSP ON 9/28/96.
ON 9/18/96, PT HAD PTCA PROCEDURE LEFT CIRCUMFLEX ARTERY. FINDINGS-RESTENOSIS LEFT CIRCUMFLEX. PTCA WITH 3.0 BALLOON. UNABLE TO PASS STENT SYSTEM TO LESION MID-CIRCUMFLEX AFTER INITIAL PTCA. STENT SYSTEM REMOVED OVER WIRE AND OUT OF BODY. STENT NOT ON END OF BALLOON; BELIEVED TO BE IN PROXIMAL CIRCUMFLEX. HIGH PRESSURE BALLOON INSERTED AFTER GUIDE REMOVED AND NEW GUIDE INSERTED. (LOST STENT IN PROXIMAL LEFT CIRCUMFLEX-HAD TO CRUSH STENT WITH HIGH PRESSURE BALLOON IN PROXIMAL LEFT CIRCFLEX). PT ANTICOAGULATED. PHYSICIANS WERE CONCERNED OF THE POSITIONING OF THE STENT; STENT POSSIBLY IN THE CIRCUMFLEX AND/OR LEFT MAIN CORONARY ARTERY. ASKED SURGEON TO CONSIDER CORONARY ARTERY BY PASS GRAFT SURGERY WHICH WAS CARRIED OUT ON 9/20/96.
ALLEGED INFECTION, SEROMA AND NIPPLE NECROSIS. FOLLOW-UP FINDINGS: AS PER PHYSICIAN ETIOLOGY UNKNOWN.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFORMATION DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFORMATION CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR IT'S EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS APPLIED DURING A OPEN CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS APPLIED TO THE CYSTIC DUCT DURING THE ORIGINAL PROCEDURE DID NOT HOLD. A REOPERATION WAS PERFORMED TO CORRECT THIS CONDITION. THE HOSPITAL STATED THE CLINICALLY APPLIED DEVICE WAS DISCARDED.
THE SVC REPORT SHOWS THAT WHILE PERFORMING AN INCOMING EVAL OF THE DEVICE, THE VOLUMES WERE FOUND TO BE OUT OF SPEC. THE CO SVC TECHNICIAN INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
CODE 000: CUP SEAL. BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE INITIAL INFO RECEIVED ON A MEDWATCH FORM ON 10/7/96, IS REPLICATED IN SECTIONS A-F. THIS INFO WAS CONFIRMED DURING A TELEPHONE CONVERSATION WITH RISK MGR ON 10/9/96. THE FOLLOWING ADD'L INFO WAS OBTAINED. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. DEVICE CODE 1179.
THE PT WAS IMPLANTED WITH DEVICE ON 9/9/94. ON 3/18/96 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION AND CAPSULAR CONTRACTURE IN THE PT'S LEFT BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. "SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF REQUIRED THEREBY. CO EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSABLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION".
DURING A PTCA PROCEDURE, THE GUIDEING WIRE BECAME CAUGHT AT THE ANASTIMOTIC SITE. THE WIRE WAS TORQUED REPEATEDLY AND THE TIP FRACTURED. THE TIP WAS RETRIEVED WITH A SNARE. PT STATUS IS LISTED AS "OK".
RETURNED PRODUCT ANALYSIS REVEALED THE CORE WIRE AND SPRING TIP WERE SEPARATED FROM THE MAIN WIRE. THE WIRE WAS TWISTED AT THE SITE OF THE FRACTURE. THE SEPARATION APPEARS TO BE CAUSED BY TORQUEING FORCES APPLIED ON THE WIRE.
THE PRODUCT WAS USED DURING A A+P REPAIR. DURING REMOVAL OF THE PACKING BLEEDING WAS NOTED. THE SURGEON CONTROLLED THE BLEEDING AND OBSERVED A ONE INCH OPENING IN THE SUTURE LINE. CHROMIC SUTURE WAS USED TO RECLOSE THE WOUND.
10/25/96-SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
NO ADD'L INFO HAS BEEN RECEIVED DESPITE REQUEST TO USER FACILITY. RETURNED LENS WAS EVALUATED AND FOUND TO BE COVERED WITH BLOOD AND CLINICAL SOLUTION. NO DEFECTS WERE OBSERVED. THIS REPORT WAS MAILED IN TO FDA ON: 10/23/96. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED=1.
THE CUSTOMER DISCOVERED DURING TESTING THAT THE AUDIBLE ALARM VOLUME WAS TOO LOW. THE SVC TECHNICAN VERIFIED THE LOW ALARM VOLUME AND ADJUSTED THE ALARM CONTROL CIRCUIT. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
PT WAS ON A CONTINUOUS INFUSION OF "FLORAN" PER INFUSION PUMP. PUMP AND SUPPLIES PROVIDED BY ONE PROVIDER. A DIFFERENT PROVIDER DISPENSED DRUG. THE CASSETTE WAS NOT COMPLETELY CONNECTED TO THE PUMP. PT BECAME SEVERELY SYMPTOMATIC BEFORE HUSBAND DISCOVERED THE PROBLEM. PT WAS HOSPITALIZED IN ICU. PT WAS IMPROVING FROM CRISIS WHEN SHE BECAME COMATOSE (9/7/96). PT DIED 9/8/96.
THE DEVICE WAS USED DURING A LAPAROSCOPIC BILATERAL TUBAL LIGATION. AFTER THE SEVERAL UNSUCCESSFUL ATTEMPTS, THE SURGEON ACHIEVED PENETRATION AND BLEEDING WAS OBSERVED. THE SURGERY WAS CONVERTED TO A LAPAROTOMY AND A LACERATION TO THE COMMON ILIAC VEIN WAS NOTED AND REPAIRED.
ADDITIONAL INFO WAS RECEIVED FROM THE USER FACILITY ON 1/8/97. THIS REPORT WAS MAILED IN TO FDA ON: 2/6/97.
USER FACILITY REPORTS EVENT WAS NOT LENS RELATED.
4/02/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
THE PT WAS IMPLANTED WITH DEVICE 4/1/96. ON 10/2/96 THE PHYSICIAN NOTED EXTRUSION ANS CAPSULAR CONTRACTURE IN THE PT'S RIGHT BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. "SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. CO EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSABLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION".
THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER ALLEGED THAT THE AUDIBLE ALARM DID NOT ACTIVATE. THE CUSTOMER'S BIO-MED TECHNICIAN COULD NOT DUPLICATE THE EVENT. IT HAS NOT BEEN VERIFIED THAT THE UNIT FAILED TO ALARM AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE. THE HOSPITAL'S OWN BIO-MEDICAL DEPT PROVIDES ITS OWN IN-HOUSE REPAIR. NELLCOR PURITAN BENNETT WAS NOT AUTHORIZED TO REPAIR THE DEVICE.
THIS HOMECARE PT REPORTED VOMITTING DARK BROWN BLOOD ON 9/16/96, AND WAS ADMITTED TO THE HOSP. PHYSICIAN REPORTED THE TUBE AS "SHARP" AND MAY HAVE CAUSED THE INTESTINAL BLEEDING. ADD'L REPORT FROM PHYSICIAN'S OFFICE STATED THE TIP OF THE TUBE WAS RUBBING AGAINST THE INNER LINING OF THE STOMACH AND CAUSED AN ULCERATION. THE ULCER WAS BLEEDING. THE SUBJECT TUBE WAS REMOVED ON 9/17/96 AND A NEW PEG TUBE WAS PLACED. THE PT WAS GIVEN CARAFATE. ONE PT INVOLVED.
CO STANDARD PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE REPORTER FOR COMPLETION AND RETURN. IN THIS CASE, THE REPORTER DID NOT PROVIDE THE REQUIRED INFO FOR THE FOLLOWING SECTIONS: A4; B6; D10; F2; F6; F9, AND F10. EVALUATION: SAMPLE WAS RECEIVED IN ITS ORIGINAL PACKING, ORIGINAL SEAL (UNBROKEN) W/NO VISUAL DEFECTS BEING FOUND. SAMPLE WAS NOT FOUND TO BE SHARP AT THE DISTAL END. NO DEFECTS WERE FOUND OF ANY KIND. COMMENTS: NO VISUAL OR FUNCTIONAL DEFECTS NOTED ON SET RETURNED.
ON 8/23/96 PT HAD 18G CATHETER PLACED IN LEFT CEPHALIC VEIN. IT WAS ADVANCED 18 CM, WITHOUT DIFFICULTY. FLUSHED EASILY WITH BRISK BLOOD RETURN. ON 9/4/96 PT CAME IN TO HAVE CATHETER REMOVED. UNABLE TO PULL OUT COMPLETELY. FLUSHED WITH SALINE, LEAKED FROM INSERTION SITE. DRESSING APPLIED. PT SENT TO MD OFFICE AND WITH EFFORT MD DC'D LINE. MD FELT THERE WAS PIECE IN VEIN WHICH SHOWED UP ON X-RAY. MD SENT PT TO SURGEON WHO EXPLORED VEIN AND WAS ABLE TO FIND FOREIGN BODY ON X-RAY. PT HAS NOT SUFFERED ANY ILL EFFECTS.
THE SVC REPORT SHOWS THAT THE CUSTOMER REPORTED THAT THE AUDIBLE ALARM FAILED TO ACTIVATE. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND WAS ABLE TO VERIFY THE REPORTED CONDITION. CSE REMOVED AND REPLACED THE AUDIBLE ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. HOSP STAFF VERIFIED THAT THE PT WAS NOT INJURIED AS A RESULT OF THE ALLEGED MALFUNCTION. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEIVCE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED INT HIS REPORT.
PURSUANT TO INFO RECEIVED FROM THE PHYSICIAN, THE PT WAS BILATERALLY IMPLANTED WITH A SMOOTH SALINE DEVICE ON 11/22/95. ON 1/1/96, THE PHYSICIAN NOTED EXTRUSION AND CAPSULAR CONTRACTURE IN THE PT'S RIGHT BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY, MENTOR H/S EXPRESSLY DENIES THAT ANY INFORMATION CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVEIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION
TWO SUTURELESS LEADS WERE REMOVED FROM SERVICE. THE PHYSICIAN ELECTED TO PERFORM AN INVASIVE PROCEDURE TO CAP THE LEADS DUE TO LOW IMPEDANCE MEASUREMENTS AND SPURIOUS SHOCKS TO THE PT. THE LEAD WAS REPLACED WITH TWO NEW SENSING LEADS.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE  FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON INAPPROPRIATE SHOCKS. NO FURTHER INFO IS AVAILABLE.
DISTRIBUTOR RECEIVED INFO THAT A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD SYSTEM EXPERIENCED OVERSENSING AND INAPPROPRIATE THERAPY. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO REMOVE FROM SERVICE (CAPPED) THE TWO UNIPOLAR RATE SENSING LEADS. A NEW BIPOLAR RATE SENSING LEAD WAS IMPLANTED. THIS PROCEDURE WAS PERFORMED ON 8/9/94. A RECENT DISTRIBUTOR INTERNAL DEPT REVIEW IDENTIFIED PAPERWORK FROM THE 8/9/94 PROCEDURE. ON 10/25/96, CO LEARNED THAT THIS PT'S COMPLETE (ICD) SYSTEM WAS REMOVED 8/26/96 DUE TO INFECTION.
THE SVC REPORT SHOWS THAT WHILE WORKING ON A WATER DAMAGED EXHALATION COMPARTMENT OF THE VENTILATOR, THE CO CUSTOMER SUPPORT ENGINEER FOUND THE FILTER HEATER ASSEMBLY WAS COLD AND NOT FUNCTIONING. THE CO FOUND THAT ONE OF THE SPADE CONNECTORS FROM THE INTERCONNECT HARNESS WAS DETACHED FROM THE CONNECTOR AT THE HEATER ASSEMBLY. THE CO RECONNECTED THE SPADE CONNECTOR AND VERIFIED THAT THE CONNECTOR WAS WELL INTACT. THE UNIT PASSED EXTENDED SELF TESTING. NO PARTS WERE REPLACED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE VALVE DID NOT DRAIN ENOUGH ACCORDING TO ITS PERFORMANCE LEVEL. UNDERDRAINAGE WAS SUSPECTED.
THE PRODUCT WAS EXAMINED AND EVALUATED BY CO FOR PATENCY, SIPHONING, PRESSURE/FLOW CHARACTERISTICS AND PREIMPLANTATION PRESSURE. THE PRODUCT MET SPECS FOR PATENCY, SIPHONING AND PRESSURE/FLOW AT 50.0 ML/HR (-50 CM HP), 5.0 ML/HR (-50 CM HP), 50.0 ML/HR (0 CM HP) AND PREIMPLANTATION PRESSURE. THE PRODUCT TESTED 0.5 CM LOW AT 5.0 ML/HR (O CM HP) DUE TO FOREIGN MATERIAL IN THE DELTA SIPHON CONTROL AREA. BROWN PROTEINACEOUS MATTER WAS SEEN AROUND VALVE DISK. THERE WAS A RESIDUE ON UPPER AND LOWER MEMBRANE SEAT AREAS OF SIPHON CONTROL. A PARTICLE WAS FOUND IN UPPER MEMBRANE AREA ON SIPHON CONTROL. CODES IN F10 PROVIDED BY MFR. THEY ARE COVERED IN LABELING.
A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY. DURING DEPLOYMENT ATTEMPT, THE STENT DISLODGED FROM THE BALLOON CATHETER TO AN UNKNOWN LOCATION. THE PT WAS SENT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
DURING INSERTION OF THE SPRING WIRE GUIDE IT KINKED. ANOTHER MFR'S 0.030" WIRE GUIDE WAS USED. AFTER GETTING THE BALLOON IN POSITION, THEY COULD NOT REMOVE THE SPRING WIRE GUIDE. THE CATHETER AND WIRE GUIDE WERE THEN REMOVED AS A UNIT. AT THIS POINT THE PT WAS STABILIZED, SO ANOTHER ATTEMPT AT INSERTION WAS NOT MADE. THERE WERE NO PT COMPLICATIONS.
MFR CONTROL NO. DI96-235. THE SAMPLE WAS RETURNED FOR EVAL. THE SPRING WIRE GUIDE WAS STILL IN THE RETURNED IAB. CO WAS ABLE TO REMOVE THE WIRE GUIDE WITHOUT ENCOUNTERING ANY RESISTANCE. THE WIRE WAS FOUND TO BE INTACT. CO 0.030" WIRE GUIDE  WAS PASSED THROUGH THE CATHETER WITH NO RESISTANCE ENCOUNTERED. BASED ON THIS ANALYSIS, CO WAS UNABLE TO DETERMINE WHY THE USER COULD NOT RETRACT THE WIRE GUIDE FROM THE CATHETER.
THE SVC REPORT SHOWS WHILE CONDUCTING AN INSPECTION OF VENTILATOR, THE CO CUSTOMER SUPPORT ENGINEER NOTICED THE FILTER HEATER TO BE INOPERATIVE. THE CO REPORTED THE CONDITION TO THE CUSTOMER, BUT WAS NOT AUTHORIZED TO REPAIR THE UNIT. IT WAS REPORTED THAT THE CUSTOMER WOULD REPAIR THE UNIT. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY WERE UNSUCCESSFUL. DURING AN ATTEMPT TO WITHDRAW THE DELIVERY SYSTEM AND THE UNSHEATHED STENT, THE STENT DISLODGED ONTO THE GUIDE WIRE. A MICROSNARE WAS INSERTED TO RETRIEVE THE STENT. THE STENT AND DELIVERY SYSTEM WERE WITHDRAWN TO THE ILIAC REGION WHERE THE STENT DISLODGED AGAIN. ANOTHER BALLOON CATHETER WAS INSERTED THROUGH THE STENT. UPON WITHDRAWAL TO THE AREA OF THE FEMORAL SHEATH, THE STENT EMBOLIZED TO THE SUBCUTANEOUS TISSUE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE PT WAS IMPLANTED WITH A SALINE IMPLANT ON 7/5/96. ON 7/19/96 THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION AND SEROMA IN HER LEFT BREAST. REMOVED THE PROSTHESIS ON 9/30/96. NO ADD'L INFO REAGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME.
ADD'L INFO TO BE SUBMITTED Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. "SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. CO EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION"
WHEN REMOVING STYLET FROM PT, A 10 CM PIECE OF THE STYLET'S SHEATH WAS TORN FROM THE WIRE AND REMAINED IN THE PT. STYLET WAS REMOVED.
THE PROSTHESIS WAS IMPLANTED AFTR A PREVIOUS DIALYSIS SHUNT FAILED BECAUSE OF INFECTION. THREE MOS. P.O., PROSTHESIS THROMBOSED NECESSITATING EMBOLECTOMY. FOLLOWING EMBOLECTOMY, SWELLING OCCURRED RESULTING IN A CYST. AT FOUR MOS. P.O., REVISION REVEALED SEROUS FLUID LEAKING THROUGH GRAFT WALL AT ARTERIAL END. THE LEAKING SEGMENT WAS REMOVED AND REPLACED WITH ANOTHER PROSTHETIC MATERIAL.
THA SAMPLE CONSISTS OF ONE SEGMENT OF 6MM THIN WALLED VASCULAR GRAFT, MEASURING APPROX 4 CM IN LENGTH. A SLIGHTLY BEVELED ANASTOMATIC END IS NOTED ALTHOUGH NO SUTURES ARE VISIBLE. THE APPOSITE END IS SQUARELY CUT. THIN REDDISH BROWN CLOT COVERS A PORTION OF THE LONGITUDINAL ASPECT OF THE GRAFT OUTER SURFACE. SMALL NODULES OF FIRMLY ADHERENT FIBROUS MATERIALS ARE NOTED WITHIN 1.5 CM OF THE ANASTOMOSIS. MUCH OF THE REMAINDER OF THE GRAFT OUTER SURFACE APPEARS FREE OF TISUE AND THROMBUS. THE GRAFT WALL IS UNIFORMLY LIGHT BROWN. THIN, SOFT, REDDISH-BRWON THOMBUS LINES MOST OF THE LUMINAL SURFACE. TWO LONGITUDINAL SECTIONS ARE SUBMITTED FOR HISTOLOGICAL EVALUATION. SECTION 9-2396-1A IS A LOONGITUDINAL SECTION AT THE ANASTOMAOTIC END. SECTION 9-2396-1B IS A LONGITUDINAL SECTION TO INCLUDE PORTIONS OF LTHE GRAFT WALL THAT ARE DEVOID OF TISSUE OR THROMBUS. HISTOLOGICAL OBSERVATIONS ARE CONSISTENT WITH LOCALIZED TRANSMURAL SEROUS FLUID ULTRAFILTRATION AS WELL AS AREAS OF EARLY HEALING IN A GRAFT OF RELATIVELY SHORT IMPLANT DURATION. THE FINDINGS ARE ALSO CONSISTENT WITH RELATIVELY POOR HEALING FOR AN IMPLANT DURATION OF FOUR MONTHS. AS PORTIONS OF THE GRAFT WALL MAY HAVE CONTRIBUTED TO THE SEROUS FLUID ULTRAFILTRATION IN THOSE REGIONS.(*0
PT SCHEDULED FOR REMOVAL OF SILICONE BREAST PROSTHESIS. ON INITIAL INSPECTION, BOTH RIGHT AND LEFT IMPLANTS WERE LEAKING.
THE SVC REPORT SHOWS THAT WHILE THE CUSTOMER SUPPORT ENGINEER WAS PERFORMING SVC ON THE VENTILATOR FOR AN UNRELATED ISSUE. THE CO OBSERVED THE AUDIBLE ALARM TO BE INTERMITTENT. THE AUDIBLE ALARM ASSEMBLY WAS REMOVED AND REPLACED AND THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE PACER KEPT REVERTING TO VVI AT 60. THE PACER WAS REPROGRAMMED TO THE DDD MODE. LEAD IMPEDANCE WAS AT 533 OHMS. THRESHOLD MARGIN TEST WAS OK. PLANS TO REPLACE THE PACER WAS MADE. THE PT WAS SEEN IN EMERGENCY ROOM WITH VVI AT 60 AND INTERMITTENT LOSS OF OUTPUT, AFTER AN EPISODE THE NIGHT BEFORE WHERE HE COMPLETELY LOST CONSCIOUSNESS AND FELL, STRIKING HIMSELF IN THE FACE ON A DOOR. A VENTRICULAR LEAD FRACTURE WAS FOUND AT EXPLANT.
CODE 79 ASSIGNED IN H.6 AS IT WAS CONCLUDED FROM THE OPERATIVE REPORT THAT USER ERROR CAUSED THE IOL TO FLIP. THE PHYSICIAN RELEASED THE INSERTER TOO EARLY CAUSING THE IOL TO FLIP (OPERATIVE REPORT READS THAT THE LENS WAS RELEASED FROM THE INSERTER JUST AS THE HAPTIC REACHED THE SULCUS AND FLIPPED 180 DEGREES.
THE IOL WAS INTRODUCED INTO THE CILIARY SULCUS. IT WAS NOTED THAT THE LENS WAS RELEASED FROM THE INSERTERS JUST AS THE HAPTIC REACHED THE SULCUS AND THE LENS FLIPPED 180 DEGREES SO THAT IT WAS ORIENTED IN A LEFT-HANDED POSITION. THE LENS WAS MANIPULATED INTO THE SULCUS WITH A MCPHERSON FORCEP. THE HAPTIC APPEARED TO BE INTRACAPSULAR AND THE LENS HAD A PLANAR POSITION AND WAS WELL CENTERED, THEREFORE NO FURTHER MANIPULATION WAS PERFORMED. THE IOL WAS NOT SEEN TO BE DISLOCATED UNTIL THE FIRST DAY POST OPERATIVE AND THEN TAKEN BACK TO SURGERY FOR EXPLANTATION OF THE IOL AND REPLACEMENT OF A NEW LENS.
AN EXTENSIVE DISSECTION OCCURRED FOLLOWING A PTCA TO THE PT'S RIGHT CORONARY ARTERY. ANOTHER MFR'S STENT WAS SUCCESSFULLY DEPLOYED AT THE SITE OF DISSECTION IN THE PT'S RIGHT CORONARY ARTERY. ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE WERE UNSUCCESSFUL DUE TO TORTUOUS ANATOMY. THE SHEATH SLID FORWARD OVER THE STENT AND AS A RESULT THE STENT DISLODGED AND EMBOLIZED WITHIN THE RIGHT CORONARY ARTERY. THE PT WAS SENT FOR NON-URGENT CORONARY ARTERY BYPASS GRAFT SURGERY A FEW HRS LATER. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON LOW IMPEDANCE OR THE OPPOSITION TO THE FLOW OF AN ALTERING CURRENT. NO FURTHER INFO IS AVAILABLE.
PHYSICIAN WAS PERFORMING HYSTEROSCOPY WITH RESECTION,USING A RESECTOSCOPE LOOP. WHILE USING THE FIRST LOOP, THE INSTRUMENT BROKE, BUT DID NOT COMPLETELY SEPARATE. A NEW LOOP WAS TAKEN FROM THE PACKAGE, AND DURING THE FIRST PASS OF THE INSTRUMENT, THE ENTIRE LOOP BROKE OFF INTO THE PT. PT'S UTERUS WAS PERFORATED DURING ATTEMPT TO REMOVE DEVICE FRAGMENT. FRAGMENT MAY STILL BE RETAINED; PT AWARE.
THE CUSTOMER ALLEGED THAT THE AUDIO ALARM VOLUME WAS LOW. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND REPLACED THE AUDIO ALARM AS A PRECAUTION. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE ALARM WAS OPERATING OUTSIDE OF SPECS, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
CUSTOMER WAS DRIVING DOWN HER RAMP WHEN HER CHAIR PULLED TO THE RIGHT. SHE ALLEGES THAT THE FRONT RIGHT WHEEL WENT OFF THE RAMP, CAUSING HER TO FALL OUT, ALLEGEDLY FRACTURING HER RIGHT SHOULDER. SHE STATED THAT THE CUSTOMER WAS USING HER SEATBELT, BUT SHE STATED THAT IS WAS NOT LATCHED PROPERLY.
400 - TIRE PRESSURE. CO'S CONCLUSION IS THAT THE CUSTOMER DID NOT PROPERLY MAINTAIN THE WHEELCHAIR FOR PROPER FUNCTION, AND THE BEARING FAILURE IS INDETERMINATE DUE TO INSUFFICIENT INFO TO DETERMINE ROOT CAUSE. ALSO NOTE: CO'S REPEATED REQUEST FOR MEDICAL DOCUMENTS HAVE GONE UNANSWERED. NO FURTHER ACTION CAN BE TAKEN. THE CHAIR WILL BE REPAIRED AND RETURNED TO THE CUSTOMER. ADD'L INFO WILL BE SUBMITTED IF MADE POSSIBLE.
DURING A ROUTINE MAINTENANCE PROCEDURE ASPIRATION THROUGH THE SYSTEM WAS IMPOSSIBLE AND WHEN FLUSHING WAS TRIED A S.C. DEPOT DEVELOPED. SUBSEQUENT X-RAY SHOWED THAT THE CATHETER HAD DISLOCATED, AND WAS NOW LOCATED IN THE RIGHT ATRIUM. CATHETER WAS REMOVED VIA TRANSFEMORAL VENOUS-PUNCTURE AND THE SYSTEM WAS EXPLANTED. "THERE WAS A DISCONNECTION OF THE TUBE SYSTEM IN THE LAST THIRD OF THE TRANSITION PART BETWEEN CATHETER AND TUBE DIRECTLY AFTER THE END OF THE CLAMP." THE REASON FOR THE DISLOCATION OF THE PORT-TUBE-SYSTEM HAS NOT BEEN CLARIFIED YET.
DEVICE SENT TO HEALTH AUTHORITY BY HOSPITAL. REQUESTS FOR ADD'L INFO REGARDING THE INCIDENT AND METHOD OF IMPLANTATION, I.E. WERE INSTRUMENTS USED, HAVE BEEN MADE BUT NO RESPONSE RECEIVED. IT IS BELIEVED THE HEALTH AUTHORITY WILL CONDUCT EVAL. BUT CO HAS BEEN UNABLE TO CONFIRM THIS AT THIS TIME. ENTIRE FORM COMPLETED BY MFR. DEVICE WAS NOT DISCARDED BUT IS UNK IF IT WILL EVER BE RETURNED TO MFR. FOR EVAL.
DEFIBRILLATOR WAS SHOCKING PT UNNECESSARILY-REPLACED WITH NEW ONE ON 8/28/96.
BLUE ADAPTORS FROM VENT TUBING TO TRACH OR ET TUBE HAVE CHANGED. THE END BUTTON IS NOW ONLY 1/4" DIAMETER AND DOES NOT SNAP ON LIKE THE 1/2" ONE FROM THE EARLIER MODEL DOES. THE DEVICE POPS OPEN FREQUENTLY AND CAUSES THE LOSS OF VOLUME AND BODY FLUID EXPOSURE TO EMPLOYEES.
THE SVC REPORT SHOWS THAT THE VENTILATOR COULD NOT ESTABLISHED A SOLID SETTING. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND REMOVED AND REPLACED BOTH AUTO-ZERO SOLENOIDS. THE CO REPORTED THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
H6 METHOD DEVICE NOT EVAL. DEVICE NOT RETURNED. CO RECEIVED A MEDWATCH FORM FROM A USER FACILITY WHICH STATED: 'DEFIBRILLATOR WAS SHOCKING PT UNNECESSARILY-REPLACED WITH NEW ONE ON 8/28/96.' THE REPORT REFERS TO CO'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (ALTHOUGH IS REPORTED AS BEING MFG BY ANOTHER CO). THE ICD WAS REPLACED. THE REPORT ALSO INDICATED THAT THE CHRONIC LEAD SYSTEM WAS RE-USED WITH THE REPLACEMENT ICD. NOTE:PAGE TWO OF THE USER'S MEDWATCH FORM WAS NOT FORWARDED TO CO. THE ICD HAS NOT BEEN RETURNED TO CO FOR ANALYSIS. CO WILL ANLAYZE THE ICD IF IT IS RETURNED. CO WILL SUBMIT ADD'L INFO IF IT BECOMES AVAILABLE.
THE CATHETER AND WIRE GUIDE SEPARATED WHILE INSERTING THE DEVICE IN THE PT'S LEFT RADIAL ARTERY. A CUT-DOWN PROCEDURE WAS PERFORMED TO REMOVE THE SEPARATED PORTION FROM THE PT. THE SAMPLE WAS DISCARDED BY THE PHYSICIAN. THERE WERE NO PT COMPLICATIONS.
THE PACER KEPT REVERTING TO VVI AT 60. THE PACER WAS REPROGRAMMED TO THE DDD MODE. LEAD IMPEDANCE WAS AT 533 OHMS. THRESHOLD MARGIN TEST WAS OK. PLANS TO REPLACE THE PACER WERE MADE. THE PT WAS SEEN IN EMERGENCY ROOM WITH VVI AT 60 AND INTERMITTENT LOSS OF OUTPUT, AFTER AN EPISODE THE NIGHT BEFORE WHERE HE COMPLETELY LOST CONSCIOUSNESS AND FELL, STRIKING HIMSELF IN THE FACE ON A DOOR. A VENTRICULAR LEAD FRACTURE WAS FOUND AT EXPLANT.
VENTRICULO PERITONEAL SHUNT PLACED ON 10/3/95 FOR HYDROCEPHALUS DUE TO ACQUEDUCTAL STENOSIS. REVISION OF THE SHUNT, CEPHALIC END, WAS FIRST PERFORMED ON 3/25/96 DUE TO PERSISTENT DILATION OF LATERAL AND THIRD VENTRICLES CAUSING HEADACHE AND BLURRED VISION CONFIRMED BY CT OF HEAD. A SECOND REVISION OF THE SHUNT, CEPHALIC END, WAS PERFORMED ON 9/14/96 DUE TO INEFFICIENT FLOW THROUGH THE VALVE, CONFIRMED BY SHUNT TAP. AGAIN, THE PT COMPLAINED OF HEADACHE AND BLURRED VISION.
THE PRODUCT WAS NOT RETURNED TO CO. SINCE THE PRODUCT WAS NOT RETURNED CO WAS UNABLE TO CONFIRM OR CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED COMPLAINT. THE MFG RECORDS FOR THE PRODUCT WERE REVIEWED AND NO ANOMALIES WERE NOTED.
A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY. ATTEMPTS TO FULLY DEPLOY THE STENT WITH THE BALLOON CATHETER WERE UNSUCCESSFUL. A 2ND BALLOON CATHETER WAS ADVANCED AND DURING AN ATTEMPT TO FULLY EXPAND THE STENT, THE STENT EMBOLIZED DISTALLY WITHIN THE CORONARY CIRCULATION. THE PT WAS SENT FOR EMERGENT CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE PS1540 BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN NATIVE CORONARY PROCEDURES ONLY. THE RISK MGMT DEPT AT THE HOSP WILL NOT RELEASE THE STENT FOR MFR PRODUCT ANALYSIS.
A FACILITY REPORTED THAT A PT'S VENOUS NEEDLE BECAME DISLODGED AND FELL INTO THE BED. THE EBL WAS 400ML AND THE NURSE NOTED THE BLOOD ON THE FLOOR BY THE BED. THE VENOUS PRESSURE AT THIS TIME WAS NOT NOTED. THE MACHINE DID NOT ALARM. THE FACILITY STATED THE VENOUS ALARM LIMITS WERE SET AT +/-60MMHG AROUND A VENOUS PRESSURE OF 200 MMHG (THIS WAS THE INITIAL VENOUS PRESSURE). THE MACHINE HAS PASSED THE ALARM TESTING PRIOR TO THE TREATMENT. THE PT'S PRETREATMENT HCT WAS DOCUMENTED AT 30.3. THE PT BECAME HYPOTENSIVE, RECEIVED 250ML OF ALBUMIN AN 2 UNITS OF PRBC'S. THE PT RECOVERED WITH A HCT OF 35.1. THE MACHINE WAS REMOVED FROM THE TREATMENT AREA FOR INSPECTION BY THE BIO-MED DEPT. AND THE MFR. THE MACHINE'S ALARM FUNCTIONS WERE FOUND TO BE OPERATING PROPERLY. THE MACHINE DOES NOT ALARM UNLESS THE PRESSURE READING IS OUTSIDE OF THE ALARM LIMITS. CONTRIBUTING FACTORS THAT MAINTAIN A VENOUS PRESSURE ARE, ENOUGH RESISTANCE AGAINST THE END OF THE NEEDLE AND THE LEVEL OF THE NEEDLE OR HEIGHT OF THE BED. THE FACILITY STATES THE MACHINE HAS SINCE BEEN USED FOR TREATMENTS AND IS OPERATING PROPERLY.
THE FIXATOR WAS APPLIED TO TREAT A DISTAL RADIUS FRACTURE. APPROX. EIGHT DAYS AFTER APPLICATION, IT WAS NOTED THAT THE DISTAL BALL JOINT HAD LOOSENED RESULTING IN A LOSS OF FRACTURE ALIGNMENT. THE MD PERFORMED A SECOND SURGERY TO REALIGN THE FRACTURE AND REAPPLY THE FIXATOR.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ACCORDING TO CLINICIAN 4 IMPLANTS WERE PLACED DURING A ROUTINE PROCEDURE IN CLASS II BONE. THE CLINICIAN REPORTS THAT THE IMPLANT IN SITE #19 BECAME INFECTED AND WAS REMOVED 2 MONTHS POST-OPERATIVELY.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS ENDOSSEOUS DENTAL IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE AS PUBLISHED IN SCIENTIFIC LITERATURE.
THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER ALLEGED THAT WHILE THE VENTILATOR WAS IN USE ON A PT, THE HIGH PRESSURE ALARM ACTIVATED. AFTER SEVERAL ATTEMPTS TO RESET THE VENT, IT WAS REMOVED FROM THE PT. ALTHOUGH THERE WAS NO REPORTED PT INJURY, THE THERAPIST FELT THAT IF THE UNIT CONTINUED TO PRESSURIZE, THE PT COULD HAVE BEEN HARMED. IT WAS REPORTED THAT SHORTLY AFTER THE VENT WAS REMOVED, A TEST LUNG WAS PLACED ON THE UNIT AND IT BECAME OVER INFLATED. AFTER THE UNIT WAS SENT TO THE BIOMEDICAL DEPT FOR EVAL, THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE HOSP NOTIFIED CO AND A CUSTOMER SVC ENGINEER WAS SENT TO EVALUATE THE UNIT. NEITHER HE NOR THE BIO-MED TECH COULD DUPLICATE THE REPORTED PROBLEM. IT HAS BEEN SUGGESTED BY HOSP PERSONNEL THAT THE ALTHOUGH THIS CLAIM COULD NOT BE SUBSTANTIATED, THE UNIT IS NOT BELIEVED TO HAVE MALFUNCTIONED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
PT DISLODGED THE HEMOSTASIS VALVE WHEN HE TUGGED ON THE SHEATH. THERE WAS A LOSS OF BLOOD AND THE PT CODED. PRESSURE WAS  APPLIED TO THE BLEEDING SITE AND THE PT WAS INTUBATED. HE RECOVERED WITH NO FURTHER COMPLICATIONS. THE HOSP INFORMED CO THAT THERE WAS NOTHING WRONG WITH THE PT AND THAT THE CAUSE OF THIS INCIDENT WAS DUE TO THE PT PULLING ON THE SHEATH.
PLAINTIFF REPORTS THAT INITIAL BILATERAL IMPLANTATION OCCURRED ON 12/6/79. PLAINTIFF ALLEGES"...INJURIES AS A RESULT OF ...IMPLANTS CONTAINING OR CONSISTING OF SILICONE, SILICONE GEL, AND/OR AN ELASTOMER MADE OF SILICONE."
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. CO NEVER DESIGNED,MFG,OR SOLD BREAST IMPLANTS. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF A ACQUISITION OF A CO WHICH CEASED MFG AND SELLING OF IMPLANTS IN 1984. F10: LABELING-RECEIVED PER LITIGATION.
THE INDIVIDUAL WAS PARTICIPATING IN A LICENSED PLASMA DONATION PROGRAM. THE INDIVIDUAL HAD PARTICIPATED, WITHOUT INCIDENT, IN A PLASMA COLLECTION PROGRAM ON THREE PRIOR OCCASIONS. ON 8/7/96, DONOR COMPLETED HIS ROUTINE SCREENING TO DETERMINE SUITABILITY FOR PLASMA DONATION. THE ROUTINE SCREENING INCLUDES A MEDICAL HISTORY, LAB TESTING (INCLUDING HEMATOCRIT AND PLASMA TOTAL PROTEIN), AND VITAL SIGN MEASUREMENT (INCLUDING WEIGHT, TEMP, BLOOD PRESSURE AND PULSE). THE ROUTINE SCREEING FOUND THE DONOR ACCEPTABLE FOR PARTICIPATION IN THE PLASMAPHERESIS PROGRAM. A PHLEBOTOMY WAS PERFORMED ON THE DONOR AND THE PLASMA COLLECTION PROCEDURE WAS INITIATED UTILIZING THE UNIT SERIAL NUMBER 96H075. DURING THE FIRST RETURN CYCLE, A TECH OBSERVED ABNORMALLY DARK COLORED BLOOD IN THE DONOR LINE, INDICATING POSSIBLE RED CELL HEMOLYSIS. THE PROCEDURE WAS IMMEDIATELY DISCONTINUED. A URINE SAMPLE WAS REQUESTED FROM THE DONOR. THE DONOR WAS UNABLE TO VOID. AFTER A SHORT PERIOD OF TIME THE DONOR PRODUCED A FEW DROPS OF URINE WHICH APPEARED ABNORMALLY DARK. THE DONOR DENIED ANY PHYSICAL COMPLAINTS. THE DONOR WAS TRANSPORTED TO THE HOSP FOR FURTHER EVALUATION AND TREATMENT. THE DONOR WAS ADMITTED FOR OBSERVATION AND ADD'L TESTING. THE DONOR WAS DISCHARGED FROM THE HOSP ON 8/8/96. NO HOSP DISCHARGE SUMMARY COULD BE OBTAINED. THE INSTRUMENT USED (SERIAL #96H075) WAS INSTALLED, AS NEW, ON THE MORNING OF 8/7/96 BY CO'S ENGINEER. THE INSTRUMENT MET ALL OPERATIONAL SPECS PRIOR TO UTILIZATION. THE INSTRUMENT WAS USED BY A NUMBER OF DONORS PRIOR TO DONOR. CO'S REP VERIFIED THE POSSIBLE HEMOLYSIS AND OBSERVED THE DONOR VALVE OCCLUDING THE BLOOD LINE. THE INSTRUMENT WAS REMOVED FROM SVC. AN ATTEMPT TO RECOVER THE PROCEDURE DATA FROM THE INSTRUMENT MEMORY WAS UNSUCCESSFUL. THE REP PERFORMED A DIAGNOSTICS CHECK ON THE INSTRUMENT WHICH CONFIRMED A DONOR VALVE FAILURE. WHEN THE ORIGINAL DONOR VALVE WAS PLACED ON THE INSTRUMENT, THE PROBLEM COULD NOT BE DUPLICATED. THE INSTRUMENT WAS RETURNED TO CO FOR FURTHER EVALUATION ON 8/9/96.
ON 9/14 AT 8:30/A, THE PT, A IDDM, OBTAINED A FASTED READING ON HER METER USING TEST STRIPS EXP 7/97 OF 33 MG/DL. SHE ATE 1/2 BANANA AND DRANK ORANGE JUICE, FOLLOWED BY ANOTHER METER READING OF 33 MG/DL, BECAUSE SHE WAS "FEELING BAD" SHE WENT TO THE HOSPITAL WHERE A LAB RESULT OF 430 MG/DL WAS OBTAINED. THE PT WAS TREATED WITH AN INJECTION OF INSULIN AND RELEASED WHEN HER BLOOD GLUCOSE RETURNED TO NORMAL. THE METER IS CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, HOWEVER, IT IS CLEANED ONLY ONCE A MONTH, NOT THE RECOMMEDED ONCE A WEEK. QUALITY CONTROL TESTS WERE PERFORMED BY A NURSE ON 9/23. THE METER WAS IN CALIBRATION READING "OK" WHILE A CONTROL RESULT PERFORMED ON THE TEST STRIPS READ "O" OUTSIDE OF THE LABELED RANGE OF 113-169.
CO HAS COMPLETED THE INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, USE OF OFF-BRAND TEST STRIPS, OR SOME UNK ANOMALY. AT THIS POINT CO'S INVESTIGATION OF THIS MATTER IS CLOSED.
DURING AN ATTEMPT TO ADVANCE AN UNSHEATHED CORONARY STENT DISTALLY THROUGH AN EXISTING STENT, THE STENT DISLODGED AND EMBOLIZED WITHIN THE CORONARY CIRCULATION. SEVERAL ATTEMPTS TO RETRIEVE THE STENT WITH A SNARE WIRE WERE UNSUCCESSFUL. THE PT WAS SENT FOR EMERGENT CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
CO RECOMMENDS THAT THE SDS SHEATH BE MAINTAINTED OVER THE BALLOON AND STENT ASSEMBLY UNTIL POSITIONED FOR STENT DEPLOYMENT.
PRODUCT WAS IMPLANTED AS A VENTRICULAR SEPTAL PATCH ON 8/21/96. POSITIVE BLOOD CULTURE FOR CANDIDA ALBICONS 8/25/96. ECHOGENIC OPACITIES SEEN NEAR PATCH, BUT WERE NOT DEMONSTRATED TO BE CANDIDA ALBICONS. ROUTINE MEDICAL TREATMENT RESULTED IN NEGATIVE BLOOD CULTURES AFTER 8/28/96. PT RELEASED WITH NO CLINICAL EVIDENCE OF ONGOING SEPSIS. CO CONSIDERS THE ECHOGENIC IMAGING TO BE "INTERVENTION".
SEE H3, CODE 81 AND H6, CODE 68. DEVICE LOT/SN INFO NOT AVAILABLE AND DEVICE NOT RETURNED (NOT EXPLAINED). NO DEVICE EVAL POSSIBLE. AVAILABLE INFO IS INCONCLUSIVE AS TO WHETHER OR NOT AN INFECTION HAD BEEN PRESENT AT THE PATCH SITE. IF AN INFECTION HAD BEEN PRESENT, IT IS UNKNOWN WHETHER OR NOT THE PATCH PLAYED ANY ROLE. DUE TO STERILITY TESTING ON 100% OF PRODUCT UNITS, CO DOES NOT BELIEVE IT IS POSSIBLE THAT THE UNIT WAS NONSTERILE. CO CONSIDERS THIS A FINAL REPORT.
THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER ALLEGED THAT WHILE PREPARING THE UNIT FOR PT USE, THE THERAPIST NOTED THE AUDIBLE ALARM WAS NOT OPERATING. A HOSPITAL'S BIO-MEDICAL TECHNICIAN INSPECTED THE DEVICE AND NOTICED THAT THE SUPPORT ARM WAS PINCHING THE ALARM WIRES. AFTER REMOVING THE ARM, THE ALARM FUNCTIONED NORMALLY. AS A PRECAUTION THE TECHNICIAN HAS REMOVED AND REPLACED THE AUDIBLE ALARM ASSEMBLY. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE. CO WAS NOT AUTHORIZED TO REPAIR THE UNIT. THE CUSTOMER USES IN-HOUSE BIOMEDICAL TECHNICIANS TO REPAIR ANY MALFUNCTIONING DEVICES. CONCLUSIONS OF ANY MALFUNCTIONS WERE BASED ON REPORTS GIVEN BY THE CUSTOMER.
AFTER ROD IMPLANTATION LOCKING BOLT BROKE AND WAS NOT ABLE TO BE REMOVED FROM THE ROD. THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY TO EXTENSION OF ANESTHESIA TIME.
SUMMARY  OF EVALUATION: METALLURGICAL ANALYSIS RESULTS SHOW THE BOLT BROKE DUE TO EXCESSIVE NON-AXIAL AND TORSIONAL FORCES. THIS EVENT WOULD NOT BE DEVICE RELATED, BUT RATHER USER RELATED. THIS IS THE FIRST EVENT OF THIS TYPE REPORTED FOR THIS PRODUCT. QUALITY SURVIELLANCE TO MONITOR THE SYSTEM FOR FUTURE TRENDS.
THE ADAPTOR DEVICE USED BETWEEN VENT TUBING AND ET TUBE OR TRACH TUBE HAS CHANGED FROM 1/2" TO 1/4" AND POPS OPEN FREQUENTLY CAUSING LOSS IN VOLUME AND BODY FLUID EXPOSURE TO EMPLOYEES.
SURGEON IDENTIFIED WOUND BURN FOLLOWING CATARACT REMOVAL WITH LENS IMPLANT. REPAIRED WITH NYLON STITCH.
THE PT, A IDDM, BEGAN OBTAINING READINGS ON HIS METER THAT READ AS "CONTROL" FOR THREE WEEKS PRIOR TO 9/7 AND TWO WEEKS BEFORE THE ALLEGED EVENT, CEASED TAKING HIS INSULIN BASED UPON THE RESULTS. DURING THIS TIME, HE EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA. ON 9/7, A 3/P METER READING WAS 67 MG/DL. BECAUSE THE PT FELT WORSE, HE WAS TRANSPORTED PRIVATELY TO THE HOSPITAL WHERE A LAB RESULT AT 4/P OF 1184 MG/DL WAS OBTAINED. THE PT WAS ADMITTED FOR HYPERGLYCEMIA, TREATED WITH INSULIN AND IV FLUIDS AND RELEASED ON 9/16. THE METER IS NOT CLEANED CORRECTLY, ALCOHOL IS USED TO CLEAN THE METER OPTICS. THE METER WAS IN CALIBRATION ON 9/16, READING 76 VERSUS A RANGE OF 73-98.
H6 RESULT:  NO NON-CONFORMANCES.  CO IS UNABLE TO COMPLETE THEIR INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE DUE TO THE FACT THAT THE METER WAS NOT RETURNED TO LIFESCAN.  THEREFORE, CO HAS NOT BEEN ABLE TO EVALUATE THE METER TO DETERMINE WHETHER OR NOT A DEVICE MALFUNCTION MAY HAVE CONTRIBUTED TO THIS EVENT.  BATCH RECORD REVIEW INDICATES NO NON-CONFORMANCES IN THE MANUFACTURING PROCESS.  AT THIS POINT, CO CONSIDERS THIS MATTER CLOSED.  H6-BATCH RECORD REVIEW.
PRIOR TO A CO REP CHECKING THE ANESTHESIA MACHINE, A 3RD PARTY BIOMEDICAL TECHNICIAN DISASSEMBLED AND EXAMINED THE EXPIRATORY VALVE AND REPORTEDLY OBSERVED A RED STICKY RESIDUE ON THE VALVE SEAT AND OTHER INTERNAL SURFACES. STICKING OF THE VALVE DISC TO THE VALVE SEAT WAS REPORTEDLY OBSERVED. THE VALVE DISC WAS RELEASED BY APPLYING MINIMAL FORCE WITH A FINGER. THE ANESTHESIA MACHINE WAS CHECKED BY A CO REP AND WAS FOUND TO FUNCTION ACCORDING TO SPECS EXCEPT THAT THE BREATHING PRESSURE GAUGE READINGS WERE HIGH BY 5 CMH2O. THE EXPIRATORY VALVE WAS RETURNED FOR EVAL. THE VALVE WAS FUNCTIONALLY TESTED, CRITICAL DIMENSIONS WERE CHECKED AND THE VALVE WAS FOUND TO BE RELATIVELY CLEAN WITH NO DEPOSITS OR ANOMALIES THAT MAY HAVE CAUSED IT TO STICK. THE VALVE FUNCTIONED PER SPECS DURING ALL FUNCTIONAL TESTING. BECAUSE OF THE EVENT DESCRIPTION OF POSSIBLE CONSECUTIVE OCCURRENCES OF A STICKING EXPIRATORY VALVE AND THE REPORTED OBSERVATION OF A STICKY RESIDUE, CO HAS ADVISED THE UF ABOUT THE NEED FOR CLEANING OF THE DIRECTIONAL VALVES, AND PERFORMING THE PREUSE CHECKOUT PROCEDURE, BOTH ARE DESCRIBED IN THE OPERATOR'S MANUAL. CO ALSO SENT A COPY OF FDA'S 1993 ANESTHESIA APPARATUS CHECKOUT RECOMMENDATIONS TO THE HOSP ADMINISTRATOR.
THE PT DIED OF A PNEUMOTHORAX AND MI, ON THE OPERATING TABLE, PRIOR TO A HEMICOLECTOMY. AT THE BEGINNING OF THE CASE THE PT DEVELOPED RESPIRATORY COMPLICATIONS. BECAUSE MONITOR READINGS INDICATED NO FLOW OR END TIDAL CO2, THE CRNA DIAGNOSED THE PROBLEM AS A BRONCHOSPASM. STEPS WERE TAKEN TO BREAK THE SUSPECTED BRONCHOSPASM. DURING THE NEXT USE OF THE ANESTHESIA MACHINE, THE FOLLOWING DAY, A PT AGAIN DEVELOPED SYMPTOMS OF RESPIRATORY COMPLICATIONS, HOWEVER, THIS TIME THE CRNA OBSERVED THAT THE EXPIRATORY VALVE WAS STUCK CLOSED. HE REPORTEDLY FREED THE VALVE AND WAS ABLE TO COMPLETE THE CASE WITHOUT INJURY OR COMPLICATIONS.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 7/27/73 WITH EXPLANT 2/22/90.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MFG, OR SOLD BREAST IMPLANTS. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF A ACQUISITION OF A CO WHICH CEASED MFG AND SELLING OF IMPLANTS IN 1984. F10: LABELING-RECEIVED PER LITIGATION.
INTERNAL JUGULAR CATHETER INSERTED FOR DIALYSIS RESULTED IN PERFORATION INTO PERICARDIUM RESULTING IN CARDIAC TAMPONADE AND DEATH.
CLINIC RESET/OUTPT WHILE RESETTING UNIT AT THE CLINIC. MACHINE WENT BEYOND EXTENSION PARAMETERS. PSR STOPPED DEVICE, TOOK PT OUT, AND ICE WAS APPLIED. PT COMPLAINED OF PAIN. PT CALLED DR WHO ADVISED STOP CPM USE FOR 1 WEEK. IF PAIN PERSISTS, DR WOULD LIKE TO SEE PT. AT THIS TIME, NO MEDICAL INTERVENTION NEEDED.
USER FACILITY REPORTS A DIFFICULTY WITH SECUREMENT OF THE DEVICE. TO BETTER SECURE THE DEVICE, THE USER DRESSED THE SITE TO THE EXTENT THAT THE SITE WAS NOT VISIBLE FOR SITE EVALUATION. THE SITE WAS REPORTED TO BE LOCATED ON THE PT'S FOOT. AN INFUSION OF PARENTAL NUTRITION, CONTAINING CALCIUM WAS ADMINISTERED THROUGH THE DEVICE. THE FACILITY CONTACT DID NOT EXPLAIN WHY THE DRESSING WAS FINALLY REMOVED TO ASSESS THE SITE, BUT WHEN IT WAS REMOVED, ONE OF THE TOES PROXIMAL TO THE INSERTION SITE WAS NOTED TO BE BLANCHED AND THE INFUSION WAS FOUND TO HAVE EXTRAVASATED. A SURGICAL CONSULT WAS OBTAINED WITH NO TREATMENT ORDERED AT THAT TIME. THE COSMETIC SURGEON STATED THAT THE SITE APPEARED AS IF IT WOULD "HEAL ON ITS OWN". SUBSEQUENT TO THIS OCCURRENCE THE PT DEVELOPED SEPSIS, WHICH THE FACILITY BELIEVES ORIGINATED AT THE FORMER INSERTION SITE. THE SEPSIS WAS CHARACTERIZED AS A STAPHYLOCOCCUS INFECTION. THE PT WAS TREATED WITH IV ANTIMICROBIAL INFUSION AND VENTILATORY ASSISTANCE. THE PT IS REPORTED TO BE "DOING MUCH BETTER" AT THE TIME OF THIS REPORT. THE FACILITY CONTACT STATED THAT THE EXTRAVASATION WAS NOT CONSIDERED A DIRECT RESULT OF THE DEVICE, BUT WAS RELATED TO LACK OF ASSESSMENT WHICH OCCURRED BECAUSE THE DEVICE WAS SO HEAVILY DRESSED.
DATE SENT TO FDA: 10/22/96. A3-UNKNOWN. D-9: ACTUAL DEVICE NOT AVAILABLE, BUT OTHER SAMPLES FROM THE FACILITY WERE RETURNED. D10: IV CALCIUM IS CONSIDERED TO BE POTENTIALY DAMAGING TO SURROUNDING TISSUE IF EXTRACVASATION OCCURS. EXTRAVASATION CAN ALSO OCCUR WHEN INFUSING IRRITATING MEDICATIONS AS A RESULT OF VESSEL CONSTRICTION WHICH OCCURS WHEN IN RESPONSE TO INTIMAL IRRITATION. STANDARDS OF PRACTICE FOR THE INFUSION OF IV CALCIUM INCLUDE SELECTING A LARGE VESSEL WHICH WILL PROVIDE ADEQUATE HEMODILUTION TO HELP AMELIORATE INTIMAL IRRITATION AND REGULAR SITE ASSESSMENT TO DETECT POSSIBLE EXTRAVASATION. INTRAVENOUS MEDICATIONS (1996) CAUTIONS THAT THE VEIN SHOULD BE ASSESSED FOR PATENCY AND THAT A LARGE VEIN SHOULD BE SELECTED. THE REPORT INDICATES THAT THE SITE WAS DRESSED IN SUCH A WAY THAT PRECLUDED ADEQUATE SITE ASSESSMENT AND THAT THE VESSEL CHOSEN MAY HAVE BEEN SMALL ENOUGH TO BE PREDISPOSED TO INTIMAL IRRITATION. F-11 NOT KNOWN IF REPORT SENT. INVESTIGATION SUMMARY: THE REPORTING FACILITY RETURNED THREE UNUSED SAMPLES AND FOUR USED SAMPLES, WHICH THE CLINICIANS REPORTED HAVING SIMILAR DIFFICULTIES WITH. THE UNOPENED SAMPLES REPRESENT PRODUCT MANUFACTURED DURING DIFFERENT TIME PERIODS. ALL OF THE SAMPLES WERE VISUALLY INSPECTED AND FOUND TO BE WITHIN SPEC. CO CHECKED FOR THE POSSIBLE PRESENCE OF LUBRICATION ON THE HUB OF THE SAMPLES AND FOUND THE HUBS OF ALL RETURNED SAMPLES TO BE FREE OF ANY LUBRICATION ON THE HUB. MANUFACTURING RETAIN SAMPLES FROM BOTH 1995 AND 1996 WERE EXAMINED VISUALLY AS WELL. THE RETURNED SAMPLES AND THE RETAIN SAMPLES WERE ALL CONSIDERED REPRESENTATIVE OF NORMAL PRODUCTION IN SPECIFICATION AND APPEARANCE. CO WAS UNABLE TO CONFIRM ANY MANUFACTURING RELATED CAUSE FOR THE REPORTED DIFFICULTIES. IT WAS DETERMINED THAT THE DIFFICULTIES MAY HAVE BEEN RELATED TO A LEARNING CURVE EXPERIENCED BY THIS FACILITY. CO'S CLINICAL NURSE SUPPORT ASSOCIATES HAVE BEEN MADE AVAILABLE TO THIS FACILITY TO ASSIST THEM IN RESOLVING THEIR DIFFICULTIES.
THE INFUSION PUMP WAS INVOLVED IN AN OVERDELIVERY OF A MORPHINE SULFATE SOLUTION. REPORTEDLY THE PT WAS TRANSFERRED TO RADIOLOGY FOR A UGI WITH A MS DRIP AT 1 ML/HR. THERE WAS APPROX. 93 MG OF DRUG IN THE IV BAG AT THE TIME (1MG/1ML). 1.5 HRS LATER THE PT WAS UNRESPONSIVE HAVING SOME JERKING MOVEMENTS. THE IV CONTAINER WAS FOUND EMPTY. IT IS NOT KNOWN WHAT THE PUMP WAS DISPLAYING AT THE TIME. THE PT WAS GIVEN NARCAN 0.4MG IVP AND OXYGEN AT 4 LITERS. THE PT RETURNED TO PRE-INCIDENT STATUS. THE HOSPITAL WAS NOT ABLE TO DETERMINE THE CAUSE OF THE OCCURRENCE.
SECTION F COMPLETED BY THE MFR. EVALUATON SUMMARY: FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML.HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATIONS.
PT MAY AS REPORTED THROUGH A FOREIGN NEWS REPORT HAVE RECEIVED EXCESSIVE RADIATION EXPOSURE WHEN UNDERGOING RADIATION THERAPY TREATMENT ON A THERAPY DEVICE. ONE HUNDRED AND NINE PTS WERE INVOLED FROM 8/26-8/27/96. THIS HAS BEEN ATTRIBUTED TO AN ERROR IN DOSIMETERY B THE USER OF THE EQUIPMENT. THERE HAS BEEN NO REPORTED MALFUNCTION O THE DEVICE. SEVERAL OF THE PTS REPORTEDLY HAVE EXHIBITED SYMPTOMS OF CHRONIC RADIATION OVEREXPOSURE AND 3 PTS DESCRIBED AS BEING TERMINAL CANCER PTS HAVE DIED.
CO HAS NOT BEEN ABLE TO SUBSTANITATED THE INFO PROVIDED NOR OBTAINED ADD'L INFO CONCERNING THIS REPORT.
A RECALLED, FOUR YR OLD, ATRIAL, J-WIRE, BIPOLAR, RETRACTABLE SCREW PACEMAKER ELECTRODE (LEAD) OF A DIFFERENT MFR WAS EXTRACTED. ON THE CASE REPORT UTILIZED FOR THE MFR'S LEAD EXTRACTION DATA BASE, THE PHYSICIAN REPORTED A TAMPONADE/HEMOPERICARDIUM COMPLICATION. IN ADDITION, TO THE MFR'S INSTRUMENTS, AN INVESTIGATIONAL LASER DEVICE WAS UTILIZED. THE COMMENT SECTION OF THE FORM CONTAINED THE FOLLOWING: DESPITE VERY SIMPLE AND EASY ADVANCEMENT OF SHEATH TO RIGHT ATRIAL MYOCARDIUM PT DEVELOPED ATRIAL TEAR WITH CARDIAC TAMPONADE REQUIRING STERNOTOMY.
H6 CONCLUSION; CODE 68-CARDIAC TAMPONADE IS CALLED OUT AS A POSSIBLE COMPLICATION OF PROCEDURE IN LABELING.
CUSTOMER REPORTED ON FORM 3500A; SURGEON INDENTIFIED WOUND BURN FOLLOWING CATARACT REMOVAL WITH LENS IMPLANT. REPAIRED WITH NYLON STITCH.
A CO SVC REP TESTED THE SYSTEM AND FOUND IT TO MEET ITS PERFORMANCE SPECIFICATIONS, BUT NOTED ONE INTERMITTENT VENTING PROBLEM THAT COULD NOT BE REPRODUCED. THIS CONDITION WOULD NOT BE THE CAUSE OF THE REPORTED EVENT. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
A USER OF A MANUAL WHEELCHAIR CUT HER LEG AS A RESULT OF RUBBING AGAINST THE CHAIR'S HINGE PLATE. NO MALFUNCTION HAS BEEN REPORTED AND THE CHAIR IS CONTINUING TO BE USED.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFORMATION DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OF INFORMATION CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR IT'S EMPLYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. EVAL OF THE RETURNED DEVICE NOTED IT TO BE INTACT AND FUNCTIONAL. THE ALLEGED EVENT OF INFECTION IS NOT INDICATIVE OF DEVICE FAILURE. THE POTENTIAL FOR INFECTION TO OCCUR IS ADDRESSED IN THE LABELING AND IS THEREFORE NOT AN UNANTICIPATED EVENT. THE CAUSE OF THIS PHYSIOLOGICAL RESPONSE OR SURGICAL COMPLICATION IS NOT KNOWN AND CANNOT BE DETERMINED.
THE DERMATOME BLADE GOUGED THE PT, REQURING STITCHES.
THE SVC REPORT SHOWS THAT AFTER THE CUSTOMER SUPPORT ENGINEER INSTALLED A 10000 HOUR PREVENTIVE MAINTENENCE (PM) KIT, THE VENT WOULD NOT PASS THE EXTENDED SELF TEST. THE CO VERIFIED PROPER INSTALLATION OF THE PM KIT AND INSPECTED THE DEVICE. THE CO REPLACED AUTOZERO SOLENOID AND THE PRESSURE TRANSDUCER PCB. THE UNIT PASSED EXTENDED SELF TESTING AND PERFORMANCE VERIFICATION. THIS REPORT IS NOT AN ADMISSION BY CO THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
EMT'S RESPONDED TO A PERSON DESCRIBED AS CYANOTIC, WITH NOTICEABLE GASTRIC DISTENTION AND IN FULL CARDIAC ARREST. THE DEVICE WAS CONNECTED TO THE PT WITH DISPOSABLE DEFIBRILLATION/ECG ELECTRODES AND POWERED UP. THE DEVICE ALARMED "CONNECT ELECTRODES" AND WOULD NOT ANALYZE THE PT'S RHYTHM. A BACKUP DEFIBRILLATOR WAS CALLED FOR AND THE PT WAS TRANSPORTED TO THE HOSP. THE PT WAS NOT RESUSCITATED.
IN AN EVAL OF THE DEVICE, THE LOCAL CO SVC REP OBSERVED THE COVER TO THE PT CONNECTOR WAS BROKEN AND WOULD NOT CLOSE PROPERLY. THE ENCLOSURE ASSEMBLY WAS REPLACED, A COMPLETE FUNCTIONAL TEST WAS PERFORMED AND PROPER OPERATION OBSERVED. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
DURING A PORT PLACEMENT, IT WAS REPORTED THAT THE CATHETER WOULD NOT FIT THROUGH THE INTRODUCER SHEATH. THE PHYSICIAN COILED UP THE CATHETER IN THE PT'S NECK TISSUE. ANOTHER INTRODUCER WAS OBTAINED AND THE IMPLANT WAS COMPLETED A FEW DAYS LATER.
THE PT DEVELOPED AN INFECTION OF THE NECK AFTER THE IMPLANTATION WAS COMPLETED, WHICH THE PHYSICIAN BELIEVED WAS DUE TO REPEATED HANDLING OF THE TISSUE. THE INTRODUCER HAS NOT BEEN RETURNED FOR EVAL TO THE MFR. THE LOT NUMBER OF THE DEVICE HAS NOT BEEN PROVIDED TO THE MFR.
FACILITY REPORTED A RUPTURE OF A DIALYZER ON ITS 38TH USE. EBL>100CC. TREATMENT WAS RESUMED USING A NEW DIALYZER WITHOUT FURTHER INCIDENT. THE SAMPLE WAS DISCARDED BY THE CLINIC.
THE RPTR STATED THAT HIS WIFE, A TYPE II DIABETIC FOR 20 YRS, WAS HOSPITALIZED AND TREATED WITH IV GLUCOSE FOR LOW BLOOD SUGAR AND CONVULSIONS. THE PT HAS CALLED PARAMEDICS FOR LOW BLOOD GLUCOSE 2 OTHER TIMES THIS MONTH. THE RPTR WAS TOLD BY HIS WIFE'S PHYSICIAN THAT THE SUSPECT DEVICE READ 50 MG/DL TOO HIGH.
FACILITY REPORTED A GROSS RUPTURE OF A DIALYZER ON ITS 42ND USE. EBL>100CC. THERE WAS NO PT INJURY REPORTED. TREATMENT WAS RESUMED USING A NEW DIALYZER WITHOUT INCIDENT. THE SAMPLE WAS DISCARDED BY THE CLINIC.
THE CUSTOMER SUPPORT ENGINEER OBSERVED THE AUDIBLE ALARM TO BE FUNCTIONING INTERMITTENTLY. THE CO REPLACED THE ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO IS POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
THE DEVICE WAS IMPLANTED ON 5/19/94. ON 10/4/96, THE FACILITY NURSE CONTACTED THE MFR AND REPORTED THAT THE PT CAME IN FOR THERAPY AND COMPLAINED OF PAIN DURING INFUSION OF SALINE AND HEPARIN. THE FACILITY NURSE SUGGESTED A CHEST X-RAY WHICH CONFIRMED A BROKEN DEVICE CATHETER. THE CATHETER SEGMENT, APPROX 3-1/2" LONG, WAS LODGED IN THE PT'S HEART. THE DEVICE WAS THEN SCHEDULED FOR EXPLANT ON 10/4/96, AND ANOTHER PROCEDURE WAS REQUIRED TO REMOVE THE DEVICE CATHETER SEGMENT LODGED IN THE PT'S PULOMONARY ARTERY.
ON 10/11/96, THE PT CONTACTED THE MFR CONCERNING THIS EVENT. THE PT REPORTED THAT SINCE IMPLANT, EVERY TIME THEY WENT TO ACCESS THE DEVICE, THEY HAD TO MOVE HER INTO ALL KINDS OF DIFFERENT POSITIONS. THE EXPLANTED DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED WITH THE FOLLOWING RESULTS: INTERNAL DAMAGE WAS NOT SEEN ON THE DEVICE SILICONE SEPTUM MATERIAL. A 2-3/4" SEGMENT OF SILICONE DEVICE CATHETER AND DEVICE SNAP-LOCK WERE ALSO RECEIVED. ONE END OF THE SEGMENT OF DEVICE CATHETER REVEALED COMPRESSION AND ERRATICALLY CUT MATERIAL. THIS IS CHARACTERISTIC OF "PINCH-OFF" SYNDROME. THE OTHER END OF DEVICE CATHETER SEGMENT APPEARED CLEAN CUT AND ROUND IN SHAPE. THE DEVICE BODY AND DEVICE CATHETER SEGMENT WERE PATENT AND DID NOT LEAK. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED ON THIS CATALOG/LOT NUMBER AND NO MANUFACTURING VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CATALOG/LOT NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. THE FACILITY'S REPORT THAT THE DEVICE CATHETER HAD BROKEN WAS CONFIRMED BY THE MFR'S ANALYSIS OF THE RETURNED DEVICE AND CATHETER SEGMENT. BASED ON THE RESULTS OF ANALYSIS, THIS EVENT APPEARS TO BE ATTRIBUTABLE TO "PINCH-OFF" SYNDROME. THE FACILITY WILL BE ISSUED AN ARTICLE EXCLUSIVE TO "PINCH-OFF" SYNDROME DIAGNOSIS IN AN ATTEMPT TO PREVENT RECURRENCE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
THE SVC REPORT SHOWS THAT THE VENTILATOR WOULD FAIL THE COMPLIANCE TEST DURING EXTENDED SELF TESTING. THE CUSTOMER SUPPORT ENGINEER VERIFIED THE REPORTED CONDITION. THE CO INSPECTED THE DEVICE AND REPLACED THE AUTOZERO, AND THE EXHALATION PILOT CONTROL SOLENOIDS. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE IPP DEVICE WAS REMOVED FROM THE PT, DUE TO A LEAK-PUMP WOULD NOT INFLATE, AND REPLACED.
THE PORT WAS PLACED 11/28/95 FOR IV THERAPY, WHEN THE PORT WOULD NOT INFUSE, UROKINASE WAS UNSUCCESSFULLY USED. A DYE STUDY WAS THEN DONE, WHICH REPORTEDLY SHOWED THAT THE CATHETER HAD BROKEN OFF AT THE PORT STEM BUT THE CATHETER HAD NOT EMBOLIZED.
THE END OF THE CATHETER WAS REPORTED TO BE COVERED WITH A FIBRIN SHEATH. THE CATHETER LOCK WAS NOT ON THE PORT STEM BUT HAD APPARENTLY SLID DOWN THE CATHETER. THE HOSP IS RETAINING THE DEVICE, SO NO EVAL OF THE DEVICE WAS POSSIBLE. A DEVICE HISTORY REVIEW SHOWED NO RELATED MFG ISSUES AND NO OTHER COMPLAINTS OF A SIMILAR NATURE FOR THIS LOT.
THE FILTER LEGS DID NOT OPEN. THEY APPEARED TWISTED. THE DOME FORMED PROPERLY IN THE 20-21 MM CAVA. ATTEMPTS WERE MADE WITH A SNARE TO OPEN LEGS. THESE ATTEMPTS WERE UNSUCCESSFUL. ANOTHER FILTER WAS USED TO COMPLETE THE PROCEDURE.
THE FILTER LEGS DID NOT OPEN; THEY APPEARED TWISTED. THE DOME FORMED PROPERLY IN A 20-21MM CAVA. ATTEMPTS WERE MADE WITH A SNARE TO OPEN THE LEGS. THE ATTEMPTS WERE UNSECCESSFUL. A FILTER WAS PLACED ABOVE THE CO'S FILTER. NO FURTHER COMPLICATIONS WERE REPORTED. SAMPLE RECEIVED WAS A SET OF ANGIOGRAPHY FILMS. FILTER DOME DEPLOYED CORRECTLY. TWO FILTER LEGS CROSSED AGAINST THE VENA CAVAL WALL. IT IS POSSIBLE THAT THE LEGS CAN BECOME CROSSED WHILE LOADING THE FILTER INTO THE STORAGE TUB. THIS CAN CAUSE THE LEGS TO CROSS UPON DEPLOYMENT. FILTER DOME DEPLOYED CORRECTLY. TWO FILTER LEGS CROSSED AGAINST THE VENA CAVAL WALL.
THIS EVENT WAS REPORTED AS ENDOCARDITIS AND VEGETATION. THE PT IS REPORTED AS CLINCALLY FINE. THE PT WAS TREATED WITH ANTIBIOTICS. NO FURTHER INFO PROVIDED.
WHILE PERFORMING A SVC ON AN UNRELATED MATTER, THE CO CUSTOMER SVC ENGINEER OBSERVED THE LOSS-OF-POWER ALARM TO BE NON-FUNCTIONAL. THE CSE REMOVED AND REPLACED THE ALARM ASSEMBLY AND THE UNIT PASSED ITS FUNCTIONAL TESTS. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL.
THIS EVENT WAS REPORTED AS REGURGITATION AND PULMONARY EDEMA. NO FURTHER INFO PROVIDED.
THE PORT WAS IMPLANTED 7/25/96 VIA THE LEFT SUBCLAVIAN. IT WAS REMOVED 9/3/96 AS IT WAS REPORTED THAT THE CATHETER HAD BECOME DISCONNECTED FROM THE PORT.
THE PORT AND A FRAGMENT OF CATHETER UNDERNEATH THE CATH-LOCK WERE RETURNED FOR EVAL. THE CATH-LOCK WAS REMOVED EASILY FROM THE PORT STEM. UNDER MAGNIFICATION, THE CATHETER FRAGMENT HAS GRIP MARKS FROM A SERRATED JAWED CLAMPING DEVICE SUCH AS HEMOSTATS ON THE OUTER DIAMETER OF THE TUBING. THE PROXIMAL END OF THE FRAGMENT IS COMPRESSED AGAINST THE STEM SHOULDER AND FLARES OUTWARD. THIS INDICATES THE TUBING WAS BUNCHED UNDER THE CATH-LOCK AND WAS PINCHED BY AN IMPROPER CATH-LOCK CONNECTION.
ON 9/25/96, THE FACILITY INFECTION CONTROL NURSE CONTACTED A MFR NURSE AND REPORTED THAT SOMETIME AFTER SURGERY, ON 9/18/96, THE SURGEON ACCESSED THE DEVICE WITH A STANDARD NEEDLE AND THE DEVICE NOW APPEARS TO BE LEAKING. A DECISION HAS NOT YET BEEN MADE AS TO WHETHER OR NOT THE DEVICE WILL BE EXPLANTED. THE MFR NURSE RECOMMENDED THAT A DYE STUDY BE PERFORMED TO VERIFY THE LEAK.
FACILITY RISK MGR, RETURNED A CALL TO MFR WITH FOLLOW-UP ON THIS PT, ON 12/17/96, AND STATED THAT SURGERY WAS SCHEDULED FOR THIS PT ON 12/2/96; HOWEVER, PT CANCELED SURGERY AND STILL HAS DEVICE IMPLANTED. FACILITY RISK MGR WAS REPORTEDLY INFORMED BY THEIR INFECTION CONTROL PERSON THAT ALLOWING DEVICE TO REMAIN IMPLANTED DID NOT POSE AS A RISK TO PT; HOWEVER, FACILITY RISK MGR REQUESTED THAT A MFR REP CONTACT HER AND CONFIRM THAT THERE IS NO RISK INVOLVED WITH ALLOWING DEVICE TO REMAIN IMPLANTED. FACILITY NURSE WAS INFORMED THAT MFR NURSE WOULD CONTACT HER REGARDING THIS ISSUE. AFTER SEVERAL ATTEMPTS, A MFR NURSE WAS ABLE TO MAKE CONTACT WITH FACILITY RISK MGR ON 12/30/96. MFR NURSE ALSO STATED THAT SINCE IT WAS MFR'S UNDERSTANDING THAT DEVICE WAS NOT FUNCTIONAL AND COULD NOT BE FLUSHED THAT MFR HAS NO INFO RELATED TO RISK OF A NON-FUNCTIONAL DEVICE REMAINING IMPLANTED. FACILITY RISK MGR PLANS TO FOLLOW-UP WITH FACILITY STAFF. A REVIEW OF DEVICE HISTORY RECORD WAS PERFORMED AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON INFO AVAILABEL AND DUE TO UNAVAILABILITY OF DEVICE FOR ANALYSIS, NO CONCLUSIN CAN BE DRAWN AS TO CAUSE OF THIS EVENT. FACILITY WILL BE NOTIFIED OR OUR REVIEW OF THIS INCIDENT. NO FURTHER INFO IS AVAILABLE. MFR IS NOW CLOSING ITS FILE ON THIS EVENT. 11. CORRECTED DATA UNDER SECTION A1, PT IDENTIFIER WAS INCORRECTLY REPORTED AS IW. CORRECT PT IDENTIFIER IS RW. UNDER SECTION B4, DATE OF THIS REPORT WAS INCORRCTLY REPORTED AS 10/24/96. CORRECT DATE OF THIS REPORT IS 9/25/96. UNDER SECTION F6, DATE USER FACILITY BECAME AWARE OF EVEN WAS INCORRERCTLY REPORTED AS 9/25/96. CORRECTED DATE USER FACILITY BECAME AWARE OF EVENT IS 9/96.
DEVICE WAS REMOVED FROM THE PT, DUE TO A NONFUNCTIONING LEFT CYLINDER, AND REPLACED.
PT REPORTED TO FDA THAT HE HAD AN UNAPPROVED SCREW IMPLANTED APPROXIMATELY 2 YEARS AGO AND BECAME DISABLED BY THE IMPLANT. HE DID SIGN AN INFORMED CONSENT AND WAS AWARE THAT THE PRODUCT WAS NOT APPROVED AT THE TIME OF IMPLANT; ALTHOUGH THE DOCTOR SAID THE PRODUCT WOULD BE APPROVED IN A FEW MONTHS. THE PT WAS RELUCTANT TO PROVIDE MORE SPECIFIC INFO AT THE TIME OF HIS CALL TO FDA.
IS FREQUENCY OR OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? NO. IS SEVERITY OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IS SEVERITY OF THIS EVENT GREATER THAN LABELED? NO.  NO INFO AVAILABLE REGARDING UF. A REPORT OR OTHER INFO SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT NECESSARILY REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT OR BY FDA THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, OR THE REPORTING ENTITY OR ITS EMPLOYEES OR AGENTS, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE REPORTING ENTITY NEED NOT ADMIT AND MAY DENY (AND EXPRESSLY RESERVE THE RIGHTS TO DENY) THAT THE DEVICE, THE PARTY SUBMITTING THE REPORT, OR EMPLOYEES THEREOF, CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
USER WAS CLEANING EAR WITH SWAB WHEN COTTON TIP BROKE OFF AND ENTERED EAR CANAL, HAD TIP REMOVED AT DR'S OFFICE.
THE CUSTOMER REPORTED THERE WAS A PROBLEM WITH THE AUDIO ALARM. THE CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND COULD NOT VERIFY ANY ALARM MALFUNCTION. HOWEVER, CSE REPLACED THE AUDIO ALARM ASSEMBLY AND POWER SWITCH AS A PRECAUTIONARY MEASURE. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE AUDIO ALARM WAS OUT OF SPEC, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO CO'S POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK ON A FIRST USE DIALYZER. EBL 250CC. THERE WAS NO PT INJURY AND THE SAMPLE WAS DISCARDED BY THE FACILITY.
THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION AND EROSION. ADD'L LOT/SER NO: BY757 008.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CONNECTOR WAS FUNCTIONAL.
NEEDLE BREAKAGE DURING REDUCTION MAMMOPLASTY SURGERY IN WHICH NEEDLE TIP REMAINED IN PT UNTIL RE-OP TO REMOVE.
H3- NO PRODUCT AND NO LOT IDENTIFICATION PROVIDED. TESTING AND RECORDS REVIEW COULD NOT BE CONDUCTED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE JAWS SCISSORED AND DAMAGED THE CYSTIC DUCT. THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY. THE HOSP HAS STATED THAT THE PT'S CONDITION IS SATISFACTORY.
10/23/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
RECEIVED SUMMONS FROM PT'S ATTORNEYS. THE PT CLAIMS "SEVERE AND PERMANENT INJURIES, INCLUDING AN ABRASION TO THE CORNEA OF THE LEFT EYE". NO ADD'L INFO IS AVAILABLE TO ENABLE FURTHER INVESTIGATION AT THIS TIME.
ALL OF SECTION F - INFORMATION PROVIDED BY MFR. D10 - MISSING (THERAPY DATES UNK) INSTRUCTIONS UNCLEAR, CORRECT INFORMATION PROVIDED. CODE #1689 - LABELING.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. BONE LOSS WAS NOTED. THE DR REPORTED DIFFICULTY IN PLACING THE IMPLANT DUE TO A LIMITED OPENING OF THE MOUTH AND THAT THE OSTEOTOMY MAY HAVE BEEN TOO LARGE.
86=DIMENSIONAL ANALYSIS. 100=THE RETURNED COMPONENT MET CO VISUAL AND DIMENSIONAL SPECS IN ALL RESPECTS.
FACILITY REPORTED A GROSS RUPTURE OF A DIALYZER ON ITS 4TH USE. NO BLOOD WAS RETURNED, EBL>100CC. TREATMENT WAS RESUMED WITH A NEW DIALYZER WITHOUT FURTHER INCIDENT. THE SAMPLE WAS DISCARDED BY THE CLINIC.
ON 10/17/91 DEVICE WAS IMPLANTED. ON 4/12/96 THE RESERVOIR WAS REVISED. ON 8/26/96 THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER NO: BK134 005.
A NURSE INJECTED A GROWTH HORMONE INTO A PT USING A PEN AND CO'S PEN NEEDLE. THE PEN NEEDLE BROKE OFF AND HAD TO BE SURGICALLY REMOVED FROM THE PT. THE SURGERY WAS PERFORMED AT THE HOSPITAL THE PT WAS RECEIVING HIS INJECTION.
THE PEN NEEDLE WAS EVALUATED AND FOUND TO HAVE THE NEEDLE BROKE AT THE BASE OF THE UNIT. MICROSCOPIC ANALYSIS WAS PERFORMED AND REVEALED THAT THE NEEDLE WAS EXPOSED TO EXCESSIVE BENDING AND RESTRAIGHTENING BY THE USER., WHICH THEN CAUSED THE NEEDLE TO BREAK OFF. SECTION F FOR DISTRIBUTOR DOES NOT NEED TO BE FILLED OUT. THE EVENT WAS REPORTED DIRECTLY.
CUSTOMER REPORTS A SECOND INSTANCE WHERE AN INTUBATED PT ON A VENTILATOR, DEVELOPED A PNEUMOTHORAX DURING PLACEMENT OF THE FEEDING TUBE. NO OTHER DETAILS GIVEN.
NO ADD'L INFO WAS FORTHCOMING FROM THE COMPLAINT. LOT HISTORY CHECK REVEALED NO RELATED DEFECTS AND NO OTHER REPORTS WERE FOUND NAMING THESE TWO LOTS. LITERATURE REVIEW REVEALS PTS WITH TRACHEOSTOMY AND ENDOTRACHEAL TUBES PRESENT A RISK FACTOR FOR PULMONARY INTUBATION WHILE PLACING A NASOGASTRIC FEEDING TUBE. CUSTOMER PLACEMENT TECHNIQUE MOST PROBABLY CONTRIBUTED TO THE REPORTED PROBLEM. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETED AND ACCURATE.
FACILITY REPORTED THAT A DIALYZER DEVELOPED A BLOOD LEAK ON ITS FIRST USE. TREATMENT WAS ABOUT HALFWAY THROUGH WHEN THE LEAK WAS NOTICED. EBL 150CC. THERE WAS NO PT INJURY AND THE DIALYZER WAS DISCHARGED.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE DR REPORTED TAHT THE NATURAL TOOTH IN POSITION #5 ABCESSED DURING THE HEALING PHASE, POSSIBLY DUE TO THE PLACEMENT OF THE IMPLANT IN POSITION #4, AND THAT THIS CAUSED THE LOSS OF THE IMPLANT.
86=DIMENSIONAL ANALYSIS. 100=THE RETURNED COMPONENT MET CO'S VISUAL AND DIMENSIONAL SPEC IN ALL RESPECTS.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO LEFT SIDE CYLINDER FAILURE.
DURING A PHACOEMULSIFICATION PROCEDURE, THIS HANDPIECE WOULD NOT ALLOW FOR ASPIRATION. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
THE LOCATION OF THE DEVICE IS UNKNOWN. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED BY THE FACILITY TO THE MFR.
PEN NEEDLE BROKE OFF IN PT'S ARM. THE NEEDLE WAS REMOVED UNDER A LOCAL ANESTHETIC AT A HOSPITAL.
THIS MEDICAL DEVICE REPORT IS SUBMITTED BY BECTON DICKINSON AND COMPANY IN COMPLIANCE WITH 21 CFR PART 803. THE SUBMISSION OF INFO PURSUANT TO THIS RULE, OR PUBLIC RELEASE OF SUCH INFO BY FDA OR ANY OTHER PARTY DOES NOT CONSTITUTE AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND A DEATH OR INJURY.
ON 10/3/96, THE MFR SALES REP WHO WAS PRESENT DURING SURGERY REPORTED THAT THE INTRODUCER/DILATOR STARTED TO FRAY.
THE DEVICE WAS RETURNED TO THE MFR ON 10/15/96, AND HAS BEEN ANALYZED AS FOLLOWS: VISUAL EXAM OF THE DEVICE REVEALED THAT THE DILATOR WAS "BENT AND CURVED" ALONG ITS ENTIRE LENGTH. MICROSCOPIC EXAM OF THE DISTAL TIP REVEALED THAT IT APPEARED "BLUNTED, FRAYED AND CURVED INWARD". NO OTHER ANOMALIES WERE FOUND WITH THE DEVICE. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. A LOT NUMBER WAS NOT PROVIDED FOR THIS UNIT; THEREFORE A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE. IN CONCLUSION, BASED ON THE INFO AVAILABLE AND THE RESULTS OF THE MFR'S ANALYSIS APPEARS TO CONFIRM THE COMPLAINT THAT "DURING SURGERY THE DEVICE INTRODUCER/DILATOR STARTED TO FRAY". HOWEVER, THE MFR'S ANALYSIS OF THE DEVICE COULD NOT DETERMINE THE EXACT CAUSE OF THE DAMAGE SEEN ON THIS DEVICE; THEREFORE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE MFR'S INVESTIGATION OF THIS INCIDENT IS INCONCLUSIVE. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
SENSE PACE LEAD HAD AN INSULATION BREAK AND WAS EXPLANTED ON 2/21/92.
FOUR BURNS TO LEFT THIGH AREA. POOR CONTACT OF GROUNDING PAD.
MD SAW PARTICULATE IN THE EYE OF HIS PT DURING A CATARACT EXTRACTION PROCEDURE USING THIS PHACOEMULSIFICATION HANDPIECE.
THE DATE  OF MANUFACTURE HAS BEEN ENTERED IN SECTION H.4.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDER LEAK. ONE CYLINDER FOUND DISCOLORED, PROBABLE CAUSE OF FLUID LOSS. SUSPECT NEEDLE SCRATCH OR PUNCTURE. PUNCTURE SITE IS NOTED MIDLINE CONSISTENT WITH NEEDLE STICK DURING ORIGINAL IMPLANT PROCEDURE. ADD'L LOT /SER NO: BM445 001.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED EITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE.
THE PT HAD A FEMORAL NAIL IMPLANTED ON 7/21/96. THE DISTAL END OF THE NAIL BROKE OFF WHILE THE PT WAS PLAYING SOCCER. IT WAS SURGICALLY REMOVED, AND A DIFFERENT NAIL WAS PUT IN. THE DR FEELS THE FAILURE WAS DUE TO PT OVERLOAD, NOT IMPLANT DESIGN.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-RIGHT CYLINDER.
DEVICE LABEL CODES: 1701, 1738, 1043. EVALUATION SUMMARY: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
ON 10/18/96, DATASCOPE WAS NOTIFIED THAT THERE WERE NO FURTHER COMPLICATIONS FROM THE EVENT AND THE PATIENT IS RECOVERING SLOWLY. EVENT COMPLICATIONS: <PATIENT'S BLOOD PRESSURE DROP'D -RPT'D 9/25; NONE RPT'D 10/18/96> PATIENT'S CURRENT STATUS: <RECOVERING - RPT'D 10/18/96>
A PHOTOCOPY OF THE SUSPECT DEVICE WAS PROVIDED TO CO BY THE UF. THE COPY SHOWS LONG BLACK HAIR STUCK TO WHERE THE BURNS OCCURRED. THE DIRECTIONS TO SHAVE AND PREP THE PT WERE NOT FOLLOWED. PLEASE SEE CO'S PACKAGING, NUMBER TWO SPECIFICALLY.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVALUATION: THE TIBIAL INSERT CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS IT HAS NOT BEEN RETURNED TO CO BUT RATHER HAS BEEN DISCARDED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURING.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-TUBING DISCONNECTED AT THE PUMP.
PUMP HAD A FATIGUE LEAK. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
THE FACILITY DID NOT PROVIDE A LOT NUMBER FOR THE DEVICE. THE LOCATION OF THE DEVICE IS UNKNOWN.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-LEFT SIDE WOULD NOT DEFLATE.
PHYSICIAN REPORTED THAT HE SAW PARTICULATE IN THE EYE OF HIS PT DURING A CATARACT EXTRACTION PROCEDURE USING THIS PHACOEMULSIFICATION HANDPIECE.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE OF NOT BEING ABLE TO FULLY DEFLATE.
THE WIRE WOULD NOT ADVANCE THE FILTER THROUGH THE CATHETER. THE FILTER BECAME LODGED AT THE HUB. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH  ANOTHER FILTER. NO ADD'L COMPLICATIONS WERE REPORTED.
CORRECT SERIAL NUMBER FOR THIS UNIT IS P10140. THE DATE OF MANUFACTURE HAS BEEN ENTERED IN SECTION H.4.
ON 1/28/91 DEVICE WAS IMPLANTED. ON 8/19/91 AND 7/2/92 THE RESERVOIR WAS REVISED. ON 1/20/94 THE CYLINDERS WERE REVISED. ON 9/18/96 THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT DUE TO FLUID LOSS-ANEURYSMAL DILATATION OF THE LEFT CYLINDER.
TUBING HAD OR DAMAGE. TUBING WAS FUNCTIONAL. PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD TORN FABRIC AND BULGING.
REVISION SURGERY REVEALED SUBSIDENCE OF THE TIBIAL BASEPLATE. THE FEMORAL COMPONENT WAS ALSO REVISED AT THIS TIME TO A COMPATIBLE REVISION COMPONENT.
THE TIBIAL COMPONENT CAN NOT BE EVALUATED FOR THE REPORTED SUBSIDENCE AS IT HAS NOT BEEN RETURNED TO CO BUT RATHER HAS BEEN DISCARDED BY THE HOSPITAL. THE LOT CODE HAS NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE. ATTEMPTS TO OBTAIN CATALOG NUMBER AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL. THE INFO PROVIDED SUGGESTS THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH LOSS OF FIXATION.
CUSTOMER REPORTS A THIRD INSTANCE WHERE AN INTUBATED PT, ON A VENTILATOR, DEVELOPED A PNEUMOTHORAX DURING PLACEMENT OF THE FEEDING TUBE. NO OTHER DETAILS GIVEN.
ACTUAL LOT NUMBER IS UNK. NO ADD'L INFO WAS FORTHCOMING FROM THE COMPLAINANT. LOT HISTORY CHECK REVEALED NO RELATED DEFECTS AND NO OTHER REPORTS WERE FOUND NAMING THESE TWO LOTS. LITERATURE REVIEW REVEALS PTS WITH TRACHEOSTOMY AND ENDOTRACHEAL TUBES PRESENT A RISK FACTOR FOR PULMONARY INTUBATION WHILE PLACING A NASOGASTRIC FEEDING TUBE. CUSTOMER PLACEMENT TECHNIQUE MOST PROBABLY CONTRIBUTED TO THE REPORTED PROBLEM. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE ACCURATE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO DIFFICULT DEFLATION AND INFECTION AROUND THE PUMP.
A BALLOON WAS USED TO SUCCESSFULLY DILATE A LESION IN THE RIGHT COMMON ILIAC. THE BALLOON WAS THEN ADVANCED CONTRLATERAL THROUGH HEAVY CALCIFICATION FOR DILATION OF THE LEFT ILIAC. UPON INFLATION THE BALLOON BURST. RESISTANCE WAS ENCOUNTERED UPON REMOVAL AND THE BALLOON DETACHED IN THE PT. RETRIEVAL OF THE BALLOON SEGMENT UTILIZING A SNARE WAS UNEVENTFUL. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THIS DEVICE WAS RECEIVED AND EVALUATED BY THIS MFR. ONLY A VISUAL EXAM WAS PERFORMED AS THE DEVICE WAS RETURNED TO THE USER FACILITY. THE ENGINEERING EVALUATION REVEALED AN OCCLUDED AND ELONGATED SHAFT. THE BALLOON WAS DETACHED 3.8 CENTIMETERS FROM THE DISTAL TIP AND THE DISTAL RADIOPAQUE MARKER WAS NOT RETURNED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. CO'S FOLLOW UP INDICATED THAT RESISTANCE WAS MET UPON WITHDRAWAL OF THE BALLOON CATHETER AND THIS DEVICE DISPLAYED AN ELONGATED SHAFT WHICH IS CHARACTERISTIC CONSISTENT WITH EXERTION AGAINST RESISTANCE. IT WAS ALSO INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION. CO BELIEVES THESE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY. BALLOON RUPTURE AT LOWER PRESSURE MAY OCCUR IN STRICTURES EXHIBITING SHARP POINTS DUE TO CALCIFIED MATERIAL OR STAPLES. IF RESISTANCE IS FELT WHEN REMOVING A GUIDEWIRE THROUGH AN INTRODUCER SHEATH, STOP AND REMOVE THEM AS A COMPLETE UNIT TO PREVENT DAMAGE TO THE GUIDEWIRE, CATHETER OR VESSEL".
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
COMPATIBLE IV PRIMARY SET WAS ATTACHED TO PUMP. A SECONDARY LINE WITH SECONDARY SET AND FILTER SET BELONGING TO A DIFFERENT MFR WAS CONNECTED TO THE SECONDARY PORT OF THE PRIMARY SET. THE PUMP WAS SET TO HOLD/RESET AND THE BACK PRIME BUTTON WAS PUSHED. THE FILTER, INSIDE WHITE FILTER, MEDIUM, CRACKED FROM BOTTOM TO TOP.
A BIPOLAR ELECTROSURGICAL GENERATOR WAS IN USE DURING A LAPAROSCOPIC FIBROID REMOVAL PROCEDURE. THERE WAS A STOPPAGE OF CURRENT FROM THE DEVICE. ANOTHER GENERATOR WAS SUBSTITUTED TO COMPLETE THE CASE. NO PT COMPLICATIONS WERE REPORTED.
DATA STATED IN SECTION F WAS FILLED IN BY THIS MFR. UNIT WAS FOUND TO HAVE 2 TRANSISTORS (T1 AND T2) SHORTED OUT. THIS OCCURRENCE CAUSED AN OPEN FUSE SITUATION. RESULTING IN THE LOSS OF OUTPUT CURRENT. TECHNICAL PERSONNEL WERE UNABLE TO DETERMINE A CAUSE FOR THE TRANSISTORS TO SHORT. REPLACEMENT OF THE TRANSISTORS AND FUSE REACTIVATED THE SYSTEM SATISFACTORILY.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE IT WAS NOT FUNCTIONING.
REVISION SURGERY REVEALED LOOSENING OF THE TIBIAL INSERT SCREW.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE STABILIZER INSERT AND SCREW WERE VISUALLY INSPECTED AS RECEIVED. THE INSERT AND SCREW WERE ASSEMBLED ONTO TWO BASEPLATES WITH THE RESULTS OF GOOD, SECURE ASSEMBLY WITH NO PROBLEMS BEING ENCOUNTERED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INSERT WITH THE SCREW FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE LOT CODE FOR THE TIBIAL BASEPLATE HAS NOT BEEN PROVIDED SO THAT A REVIEW OF ITS DEVICE HISTORY RECORD IS NOT POSSIBLE. THE INFO PROVIDED AND THE EXAMINATION RESULTS SUGGEST THAT THE DIFFICULTY ENCOUNTERED WAS ASSOCIATED WITH THE SCREW HOLE OF THE BASEPLATE WHICH REMAINS IMPLANTED AND THEREFORE CANNOT BE EVALUATED.
THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO EROSION THROUGH URETHRAL MEATUS.
DURING TESTING, PT HAD TO INHALE AND EXHALE INTO A MOUTH PIECE WHICH GAVE INCORRECT RESULTS. FIRST, THE MACHINE ADDED THE VALVES TO THE LEFT AND TO THE RIGHT. SECOND, THE VOLUME WENT IN THE WRONG WAY AND THIRD, THE BASELINE WAS NOT CORRECT, THEREFORE, DR DID NOT KNOW IF THE CURVE WOULD BE CORRECT. THE CONCLUSION WAS THAT THIS MACHINE CALCULATED THE NUMBERS INCORRECTLY AND THE DR WAS VERY UPSET ABOUT IT. ADDITIONALLY, THE MDR REPORTS THAT THE MACHINE PRODUCES BIZARRE CURVES WHICH ARE USELESS. THE PROBLEM IS INTERMITTENT AND THE RPTR CAN NEVER TELL WHEN IT WILL WORK PROPERLY. THE DEVICE HAS EFFECTED THE CARE OF RPTR'S PTS. IT THE MALFUNCTION IS NOT RECOGNIZED OR IS IGNORED BY THE USER, IT MIGHT LEAD TO AN ERRONEOUS DIAGNOSIS.
NURSE PICKED UP A CLOSED SHARPS CONTAINER AND WAS STUCK BY AN INSULIN NEEDLE.
ON 8/3/88 DEVICE WAS IMPLANTED. ON 3/6/96 THE LEFT CYLINDER WAS REMOVED FROM THE PT. ON 9/23/96 THE RIGHT CYLINDER, PUMP AND RESERVOIR WERE REMOVED FROM THE PT AND AN ENTIRE DEVICE IMPLANTED DUE TO FLUID LOSS.
REVISION SURGERY REVEALED LOSSENING OF THE BASEPLATE. DURING THE SURGERY, THE TIBIAL INSERTS WOULD NOT SEAT PROPERLY IN THE REVISION BASEPLATE. A NEW BASEPLATE AND INSERT WERE CHOSEN AND IMPLANTED WITHOUT INCIDENT.
SUMMARY OF EVAL: THE TIBIAL BASEPLATE AND TIBIAL INSERTS WERE VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE BASEPLATE IS IN NEW CONDITION. THE ANTERIOR LOCKING TAB OF EACH OF THE INSERTS EXHIBITS INSIGNIFICANT DISTORTION AS A RESULT OF THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. A DIMENSIONAL INSPECTION OF THE BASEPLATE FOUND THAT ALL DIMENSIONS RELATING TO INSERT MATING MET DESIGN REQUIREMENTS. THE INSERTS WERE ASSEMBLED IN THE AS-RECEIVED CONDITION TO THE RETURNED BASEPLATE USING TWO-THUMBS PRESSURE. RESULTS FOR ALL THREE INSERTS WERE A CRISP SNAP ACTION WITH FULL, TIGHT SEATING. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS BASEPLATE AND INSERTS FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MANUFACTURE. THE EVAL RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACTION TOO FLEXIBLE.
THIS EVENT WAS REPORTED AS "FAILURE" AND REGURGITATION. NO FURTHER INFO PROVIDED.
F10: 2203 = CODE TISSUE OVERGROWTH. H3: EVALUATION OF THE VALVE IN CO'S LABORATORY REVEALED EXTENSIVE HOST TISSUE OVERGROWTH WHICH FUSED EACH COMMISSURE AND BOTH ATTACHMENT SITES OF THE RIGHT-CORONARY CUSP, AS WELL AS COMPLETELY COVERED THE NON-CORONARY CUSP AS NOTED FROM THE INFLOW ASPECT, WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS AND INCOMPLETE COAPTATION. CALCIFICATION WAS ALSO NOTED WITHIN EACH CUSP AND CONTRIBUTED TO STENOSIS OF THE VALVE. X-RAY  ANALYSIS REVEALED CALCIFICATION WITHIN THE AORTIC WALL, BELLY AND FREE MARGIN OF EACH CUSP. STENT DISTORTION WAS ALSO NOTED WHICH APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THE VALVE WAS DETERMINED TO BE DUE TO HOST TISSUE OVERGROWTH. THESE FINDINGS WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY. H6: 86 = X-RAY ANALYSIS.
THE POLYETHYLENE BUSHING, WHICH MAKES UP THE JOINT, MALFUNCTIONED AND ATE AT THE ANTERIOR FEMUR CAUSING PT TO DEVELOP FEMORAL OSTEOLYSIS. X-RAY REVEALED THE TITANIUM PAD ATTACHED TO THE BONE HAD SEPARATED. PT IS CRIPPLED FOR LIFE. IMPLANTED R 4/85, EXPLANTED R 8/94.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TI PT DISSATISFACTION.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDER LEAKED.
NURSE DEVELOPED SEVERE ASTHMA AFTER USING AND COMING INTO CONTACT WITH OTHERS WEARING LATEX GLOVES. SHE IS CURRENTLY TAKING PO STEROIDS AND IS ON MEDICAL LEAVE.
THE PT EXPERIENCED PAIN. REVISION SURGERY REVEALED DISLOCATION OF THE KNEE PROSTHESIS. THE TIBIAL INSERT WAS REVISED AT THIS TIME.
SUMMARY OF EVALUATION: THE TIBIAL INSERT CAN NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED TO CO BUT RATHER HAS BEEN RETAINED BY THE SURGEON. ATTEMPTS TO OBTAIN THE DEVICE AND LOT CODE INFORMATION HAVE BEEN UNSUCCESSFUL.
DURING A VITRECTOMY PROCEDURE, THE VITRECTOMY FUNCTION OF THIS UNIT WOULD NOT WORK. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE.
TO DATE, NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. IF AND WHEN PRODUCT  HAS BEEN EVALUATED, RESULTS WILL BE FORWARDED.
A DIFFERENT MFR'S IV PUMP SET WAS ATTACHED TO A COMPATIBLE PUMP. A SECONDARY LINE WITH SECONDARY SET AND FILTER SET WAS CONNECTED TO THE SECONDARY PORT OF THE PRIMARY SET. THE PUMP WAS SET TO HOLD/RESET AND THE BACK PRIME BUTTON WAS PUSHED. THE FILTER, INSIDE WHITE FILTER MEDIUM CRACKED FROM BOTTOM TO TOP.
THE SENSING LEAD OF THE DEFIBRILLATOR APPEARED TO HAVE A FRACTURE. THE PT WAS ADMITTED AND TAKEN TO THE OPERATING ROOM ON 9/12/96 FOR A GENERATOR CHANGE AND A LEAD IMPLANTATION.
THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED DURING A CATARACT PROCEDURE. ANOTHER HANDPIECE WAS USED.
THE PT EXPERIENCED PAIN. REVISION SURGERY REVEALED LOOSENING OF THE TIBIAL BASEPLATE. THE TIBIAL INSERT WAS ALSO REMOVED WITH THE BASEPLATE AT THIS TIME.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
A TOTAL OF 5 CORNEAL BURNS OCCURRED. NOTED 3 MINOR CORNEAL BURNS 2 WEEKS AGO. 1 MINOR CORNEAL BURN AND 1 SEVERE BURN OCCURRED 9/26. DOCTOR IS ONLY REPORTING THE MOST SEVERE BURN WHICH REQUIRED SUTURES.
A CO SERVICE REP CHECKED THE SYSTEM AND FOUND IT TO MEET ITS PERFORMANCE SPECS. TWO PEA HANDPIECES, 54383 AND 54385, HAD BENT NOSECONE. NO CONSUMABLES WERE SAVED. NO ADD'L PT INFO HAS BEEN RECEIVED TO DATE. THIS REPORT WAS MAILED IN TO FDA ON: 10/23/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21 CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
H6 METHOD DEVICE NOT EVALUATED. DEVICE NOT RETURNED. EVENT CONCLUSION: CO RECEIVED INFO THAT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REMOVED FROM SERVICE BECAUSE "NOISE ON THE EGRAM RESULTED IN INAPPROPRIATE SHOCKS". CO ALSO RECEIVED A MEDWATCH FORM WHICH STATES: "THE SENSING LEAD OF THE DEFIBRILLATOR APPEARED TO HAVE A FRACTURE. THE PT WAS ADMITTED AND TAKEN TO THE OPERATING ROOM ON 9/12/96 FOR A GENERATOR CHANGE AND A LEAD IMPLANTATION." A SUBCUTANEOUS PATCH LEAD AND A LEAD ADAPTER WERE REMOVED FROM SERVICE AT THE SAME TIME. NEITHER THE LEADS NOR THE ICD HAVE BEEN RETURNED FOR ANALYSIS. CO WILL ANALYZE THE ICD AND LEADS IF THEY ARE RETURNED. CO WILL SUBMIT ADD'L INFO IF IT BECOMES AVAILABLE.
THIS BIPOLAR CORD COULD NOT FUNCTION WHEN THE ATTEMPT WAS MADE TO USE IT DURING AN OPHTHALMIC PROCEDURE. ANOTHER CORD WAS USED.
DEVICE HAD SCRATCHES ON IT, AS THOUGH SOMEONE USED A TOOL ON IT TO OPEN IT UP. THERE IS SOME CORROSION ON THE CONNECTOR BUT NO DAMAGE TO THE CABLE.
DURING A CATARACT EXTRACTION PROCEDURE, THERE WAS ASPIRATION LOCK UP AFTER USING THE SCISSORS MODE ON THIS OPHTHALMIC MICROSURGICAL UNIT. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE.
THE INFORMATION CONTAINED IN THIS MDR IS OF THE TYPE CUSTOMARILY HELD IN STRICT CONFIDENCE AND REGARDED AS PRIVILEDGED BY 3M UNDER 21 CFR 20.61. THEREFORE, 3M REQUESTS THAT THE FOOD AND DRUG ADMINISTRATION TREAT THAT PORTION OF THE MDR AND BASELINE REPORT RELATING SPECIFICALLY TO THE 3M PRODUCT AS CONFIDENTIAL COMMERCIAL INFORMATION UNDER 21 CFR 803.9(B). THIS MEDWATCH INCLUDES 2 REPORTED PTS AS FROM USER FACILITY. HOWEVER, SECOND PT WAS A SEPARATE EVENT. THE INJURY FOR SECOND PT WAS NOT CONSIDERED SERIOUS PER TELEPHONE CONVERSATION WITH RPTR ON 10/14/96. THEREFORE, THIS REPORT IS FOR FIRST PT ONLY.
DURING 4-5 CATARACT EXTRACTION PROCEDURES, THIS PHACOEMULSIFICATION HANDPIECE HAS TO BE RECALIBRATED. IT WILL FUNCTION FOR APPROX 3-4 MINS AFTER THE INITIAL CALIBRATION. IT WILL FUNCTION BETWEEN 5-10 MINS AFTER THE SECOND CALIBRATION.
A RETURN GOODS AUTHORIZATION NUMBER (RGA) WAS GIVEN TO THE CUSTOMER; HOWEVER, TO DATE NO PRODUCT HAS BEEN RECEIVED.
NIBP UNIT SEEMS TO FUNCTION PROPERLY, ALTHOUGH NO PRESSURE VALVES ARE DISPLAYED. DISPLAY INDICATES "BLANK MODE." DISPLAY SWITCH ON REAR OF UNIT TURNED TO "OFF" POSITION.
TWO BALLOON CATHETERS EXPERIENCED DIFFICULT DEFLATION DURING A RENAL EMBOLIZATION PROCEDURE OF A VERY TIGHT RENAL ARTERY. BOTH CATHETERS WERE CUT AT THE PROXIMAL END OF THE SHAFT, DEFLATED AND REMOVED SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO PT COMPLICATIONS. THESE DEVICES HAVE BEEN DESTROYED BY THE USER FACILITY. THEREFORE NO FAILURE ANALYSIS WILL BE PERFORMED. CO'S FOLLOW UP REVEALED THAT BOTH BALLOON CATHETERS WERE BEING USED IN A VERY TIGHT LESION AND THAT THE POSITION OF THE CATHETER MAY HAVE BEEN A CONTRIBUTING FACTOR TO THIS EVENT. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
DURING A PHACOEMULSIFICATION PROCEDURE, THE PHACO MODE OF THIS UNIT STOPPED AND THE BIPOLAR FUNCTION WOULD NOT ACTIVATE. THE PHYSICIAN PERFORMED AN EXTRACAP (MANUAL) PROCEDURE ON THE PT.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. THIS UNIT WAS TESTED EXTENSIVELY BEFORE AND AFTER RUNNING THE UNIT FOR 100 HOURS. NO PROBLEMS WERE FOUND. AS A PRECAUTIONARY MEASURE, THE PHACO CONTROL PCB, PHACO P/S PCB POWER AMPS AND BIPOLAR P/S WERE REPLACED.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT, DUE TO AN ANEURYSM AND EROSION, AND REPLACED.
DEVICE WAS REMOVED FROM THE PT DUE TO PAIN AND PT DISSATISFACTION. ANOTHER DEVICE WAS IMPLANTED. ADD'L LOT/SER NO: AB826 002.
NIBP WOULD NOT GIVE PRESSURE. DISPLAYS READ "00". AUTO/CAL POSITION.
DURING A PHACOEMULSIFICATION PROCEDURE, THE PHACO MODE OF THIS UNIT STOPPED AND THE BIPOLAR FUNCTION WOULD NOT ACTIVATE. THE PHYSICIAN PERFORMED AN EXTRACAP MANUAL PROCEDURE ON THE PT.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. THIS UNIT WAS TESTED EXTENSIVELY BEFORE AND AFTER RUNNING THE UNIT FOR 100 HOURS. NO PROBLEMS WERE FOUND. AS A PRECAUTIONARY MEASURE, THE PHACO CONTROL PCB, PHACO P/S PCB, PHACO POWER AMPS AND BIPOLAR P/S WERE REPLACED.
MFR BECAME AWARE OF FOUR SEPARATE EVENTS AT THE SAME USER FACILITY INVOLVING 20FR INITIAL PLACEMENT GASTROSTOMY (PEG) FEEDING TUBES. THE INITIAL PROCEDURES WERE PERFORMED WITHOUT INCIDENT. THE PTS DEVELOPED INFECTIOUS SIDE EFFECTS AFTER THE PROCEDURE WAS PERFORMED. SEVERAL ATTEMPTS BY THE DISTRIBUTOR AND THE MFR TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESFUL. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT.
WHILE PERFORMING TEST ON THE UNIT, PHYSICIST WAS SWITCHING FROM SMALL FILM TRAY TO LARGE FILM TRAY BY MANUALLY ROTATING BUCKY MECHANISM. MECHANISM STRUCK PHYSICIST IN ELBOW, RESULTING IN A RADIUS HEAD FRACTURE.
REGARDING MDR REPORT INVOLVING A PHYSICIST WHO RECEIVED A FRACTURED ELBOW WHILE PERFORMING TESTS ON A MAMMOMAT 3000, THE FACTORY HAS CONCLUDED IT'S INVESTIGATION OF THE EVENT AND DETERMINED THAT THE CAUSE WAS MOST LIKELY DUE TO INATTENTION BY THE OPERATOR. ALTHOUGH SUBSEQUENT FIELD SERVICE OF THE UNIT DISCOVERED A WORN DETENT BLOCK. (PART #62 48 244), A FUNCTIONAL CHECK OF THE UNIT'S MECHANICAL STOP INDICATED THAT THE ROTATING BUCKY COULD NOT SWING PAST THE O DEGREE POSITION, EVENT WITH THE WORN DETENT BLOCK, I.E. THE STOP FUNCTIONED PROPERLY. THIS FUNCTION WAS ALSO TESTED ON A FACTORY UNIT, AFTER INSTALLING THE WORN BLOCK REMOVED FROM THE SYSTEM INVOLVED IN THE EVENT, WITH SIMILAR RESULTS. THE TECHNICAL SUPPORT ENGINEER SERVICING THE SYSTEM AFTER THE EVENT MEASURED THE FORCE REQUIRED TO SPIN THE BUCKY FROM ONE POSITION TO THE NEXT, AND FOUND IT TO BE WELL WITHIN SPECIFICATION. ADDITIONALLY, ROTATIONAL TESTS WERE PERFORMED ON A FACTORY UNIT WITH LOWER FRICTIONAL VALUES THAN THE SYSTEM INVOLVED IN THE EVENT, (ALSO WELL WITHIN SPECIFICATION), AND IT WAS FOUND THAT BUCKY ROTATION WAS IMMEDIATELY REDUCED. EVEN WITH THE APPLICATION OF EXCESSIVE FORCE IN AN ATTEMPT TO GET IT TO ROTATE RAPIDLY, THE MOTION WAS QUICKLY ARRESTED. BASED ON THESE TESTS AND MEASUREMENTS, PERFORMED ON BOTH THE ACTUAL DEVICE AND ON TWO FACTORY UNITS, ONE WITH PARTS REMOVED FROM THE ACTUAL DEVICE AND ONE WITH A LOWER FRICTIONAL VALUE FOR BUCKY ROTATION THAN THE ACTUAL DEVICE, WE ARE CONVINCED THAT THE WORN BLOCK DID NOT CONTRIBUTE TO THE OCCURRENCE OF THIS INCIDENT, AND THAT THE INJURY WAS MOST LIKELY SUSTAINED AS A RESULT OF OPERATOR ERROR.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 3/85. PT ALSO ALLEGES A RECENT MAMMOGRAM AND MRI (I.E. 1996) SHOW HER IMPLANTS ARE RUPTURED.
SUPPLEMENTAL INFORMATION RECEIVED ON DECEMBER 11, 1996 SHOWS THAT THE DEVICES WERE NOT MFR BY THIS CO.
THIS EVENT WAS REPORTED AS BACTERIAL ENDO CARDITIS WITH MULTIPLE EMBOLI.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS-LEFT CYLINDER. ANOTHER DEVICE WAS IMPLANTED.
CYLINDER HAD A WEAR LEAK. CYLINDER WAS FUNCTIONAL.
SHERWOOD DAVIS & GECK, 1915 OLIVE ST, ST LOUIS, MO 63103-1642. WE'VE COMPLETED OUR INVESTIGATION OF THE REFERENCED MEDWATCH REPORT YOU FILED ON BEHALF OF AN ANONYMOUS RPTR WHO STATED THAT THE "KANGAROO (MODEL 324) ENTERAL PUMP WOULD NOT DELIVER OVER 50ML AT A TIME; MUST RESET VOLUME DELIVERED TO DELIVER ANOTHER 50ML. THE NURSE FAILED TO REALIZE THAT THE DOSE VOLUME WAS SET TO 50ML, AND THE PUMP WAS FUNCTIONING PROPERLY." THE LAST SENTENCE CAPTURES THE ESSENCE OF OUR REPLY. THE PUMP WAS DOING WHAT IT WAS DESIGNED TO DO. THE USER TYPICALLY PRE-SETS THE DOSE FOR THE TOTAL AMOUNT OF FORMULA DESIRED. NO MATTER THE FLOW-RATE SETTING, WHEN THAT DOSE IS ACHIEVED, THE PUMP WILL ALARM AND CEASE DELIVERING FORMULA. YOU CAN CANCEL THE DOSE FEATURE BY SETTING DOSE EQUAL TO ZERO. THIS IS CLEARLY SPELLED OUT IN THE OPERATING MANUAL (SEE ATTACHMENT).
THIS EVENT WAS REPORTED AS ISCHEMIC HEART DISEASE, VALVULAR HEART DISEASE AND CARDIAC ARREST. NO FURTHER INFO PROVIDED.
F1: USER FACILITY. 2200=VALVULAR HEART DISEASE.
ON 4/13/95 AN AUS DEVICE WAS IMPLANTED. ON 10/17/95 THE PUMP WAS REVISED. ON 11/22/95 THE PUMP WAS REMOVED FROM THE PT. ON 3/27/96 THE CUFF AND RESERVOIR WERE REMOVED FROM THE PT DUE TO INFECTION.
CUFF HAD OR DAMAGE. BALLOON PERFORMED WITHIN SPECIFICATIONS.
DURING A PHACOEMULSIFICATION PROCEDURE, THIS OPHTHALMIC MICROSURGICAL UNIT HAD TO BE POWERED ON THEN OFF IN ORDER TO GET THE COLLECTION CASSETTE OUT. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH THIS UNIT.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. BALANCED SALT SOLUTION CORRODED AND SHORTED CIRCUITS ON THE CONTROL PANEL.
DISTAL END OF NAIL FRACTURED WHILE PT WAS PLAYING SOCCER.
EVAL CODES FOR SECTION H6: 86-100; 86 - A COMPLAINT HISTORY REVIEW FOR ADVERSE TRENDS WAS CONDUCTED. 100 - LAB REPORT ON BAR STOCK INDICATES THE LOT CONFORMED TO STANDARDS. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OF GREATER SEVERITY THAN IS USUAL FOR PRODUCT? UNK.  DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNK OR IS NA. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
DX: RSD RIGHT HAND. PT HAD IMPLANT OF EPIDURAL CATHETER ON 5/6/96-LEVEL C2. PT WAS PLACED ON A CONTINUOUS INFUSION ON 6/10/96. PT HAD INFUSION WITH 1/8% MARCAINE FOR APPROX. 4 WKS. PT EXPERIENCED SOME INFLAMMATION ABOVE PORT, TENDERNESS AT PORT SITE. INCREASED PAIN WITH ACTIVITY. PORT WAS REMOVED 8/26/96 DUE TO POSSIBLE INFECTION AT PORT SITE. SMALL AMOUNT OF PUS SUBCUTANEOUSLY JUST SUPERFICIAL TO THE RESERVOIR. PT WAS AFEBRILE. PT HAS BEEN ON AUGMENTIN 500MG. TID FOR 10 DAYS. THE INFECTION WAS NOT RELATED TO PORT OR POCKET. (NOT CAUSED)
THE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION OF THE CUFF.
H3: EVALUATION OF THE RING IN CO'S LABORATORY REVEALED 9 INTACT SUTURES WHICH WERE INDICATIVE OFTHE DEHISCENCE NOTED CLINICALLY ("DEHISCENCE OF THE RING FROM THE ENTIRE MURAL LEAFLET ANNUALS AND FROM ALL BUT TWO SUTURES ON THE SUBAORTIC CURTAIN AREA"). H6: 86 X-RAY ANALYSIS.
H3. THE PORTAL WAS RECEIVED WITH A 9.25 INCH LENGTH OF CATHETER ATTACHED. THE PORTAL AND CATHETER WERE MICROSCOPICALLY EXAMINED AT 10X TO 30X, NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE PORTAL AND CATHETER WERE PRESSURIZED TO 20 PSIG VIA SALINE FOR ONE MINUTE, THE SYSTEM WAS FOUND TO BE PATENT.
STAFF MEMBERS HAVE OBSERVED MASK MISSING FROM POLYBAGGED RESUSCITATOR. NO REPORTED HARM TO PT.
CURRENT INVENTORY OF CO'S RESUSCITATORS AT HOSP WERE CHECKED TO VERIFY MASK PRESENT. ALL RESUSCITATORS INSPECTED WERE FOUND TO HAVE MASK PRESENT. CO AND THE HOSP HAVE NOT BEEN ABLE TO DETERMINE IF THE REPORTED MISSING MASK WAS FOUND AS THE RESUSCITATOR WAS INITIALLY REMOVED FROM THE POLYBAG OR IF REMOVED BY HOSP STAFF MEMBERS.
ON 4/8/96 AN AUS DEVICE WAS IMPLANTED. ON 6/12/96 THE PUMP AND BALLOON WERE REMOVED FROM THE PT. ON 7/12/96 THE CUFF REMOVED FROM THE PT DUE TO INFECTION.
RESIDENT FOUND AT 9:30 PM BETWEEN SIDE RAIL AND MATTRESS. RESIDENT LIFTED BACK INTO BED UPON DISCOVERY. THE BED AND SIDE RAIL WERE OBSERVED AFTER THE RESIDENT WAS REMOVED AND A SPACE OF 2 1/4 INCHES WAS NOTED BETWEEN THE MATTRESS AND SIDE RAIL.
REMOVAL AND REPLACEMENT OF THORAIC-LUMBAR BROKEN INSTRUMENTATION.
THE PT'S PHYSICIAN CALLED CO TO REPORT THAT THE PT'S HEART VALVE WAS REPLACED DUE TO THROMBUS.
SECTION F WAS COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FORM THE USER FACILITY.
ON 7/13/95 AN AUS DEVICE WAS IMPLANTED. ON 6/5/96 THE CUFF WAS REMOVED FROM THE PT. ON 9/23/96 THE PUMP AND BALLOON WERE REMOVED FROM THE PT AND AN ENTIRE AUS DEVICE IMPLANTED DUE TO EROSION-URETHRA.
PUMP PERFORMED WITHIN SPECIFICATIONS. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS.
FIXTURE FAILED TO INTEGRATE, ABCESS FORMATION, BONE DESTRUCTION.
DIRECTOR, ANESTHESIA REPORTED A LEAK WAS OBSERVED DURING A CASE. IT APPEARED THAT FILTER LEAKED. THE FILTER WAS CHANGED. NO REPORTED HARM TO PT.
S/P BILAT ORCHIECTOMY. TUBING CURLED POSSIBLE KINK-TUBING SHORTENED-DEVICE ACTIVATED AND DEACTIVATED CYSTO DONE AFTER CLOSURE.
ARTHROSCOPIC PUMP SET UP FOR PROCEDURE (RIGHT LATERAL MENISCUS TEAR REPAIR). ALARM SOUNDED AND PUMP STOPPED DURING PROCEDURE (3X TIMES). AT COMPLETION OF PROCEDURE PT'S LEG WAS SWOLLEN AND REQUIRED FURTHER TREATMENT.
THE LEAD WAS CUT AND CAPPED DUE TO A REPORT OF LOSS OF SENSING/CAPTURE.
STAFF MEMBERS HAVE OBSERVED KINKED TUBES ON ANESTHESIA CIRCUIT. NO REPORTED HARM TO PTS.
PUMP WAS NOT FUNCTIONALLY TESTED. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON HAD A FATIGUE LEAK.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCOTINENCE.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED AT WELD SITE AND ~8MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES ~80MM AND HAS MIGRATED DOWN LEAD BODY ~20MM PROXIMAL OF WELD SITE. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES ~2.5MM OF THE PROXIMAL END OF THE J STIFFENER WIRE WHICH FRACTURED ~8MM PROXIMAL OF WELD SITE IS PROTRUDING OUT OF THE OUTER POLYURETHANE INSULATION ~10MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO ~88MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURES.
OBTAINED RESUSCITATOR FOR USE AND OBSERVED DUCKBILL VALVE LOOSE IN RESUSCITATOR BAG. ANOTHER RESUSCITATOR WAS OBTAINED AND PT RESUSCITATED. NO REPORTED HARM TO PT.
H3: SUMMARY - THE TUBE SET AND PUMP WERE RETURNED TO CO. THE TUBE SET WAS FOUND TO BE WITHIN SPEC. THE PUMP WAS FIRST INSPECTED BY THE HOSP AND WAS FOUND TO BE WITHIN SPEC. IT WAS REPORTED BY THE HOSP THAT THE PUMP PERFORMED NORMALLY DURING TESTING AND THAT THE ALARM AND PUMP INTERRUPT FUNCTIONED WITHOUT FAIL. THE CO CUSTOMER SERVICE CENTER ALSO INSPECTED THE PUMP AND FOUND THE FLOW CALIBRATION TO BE SLIGHTLY OFF THE CENTER OF THE RANGE, BUT NOT OUT OF SPEC. THE PUMP ALSO HAD THE OLD STYLE LEUR CONNECTOR, TRANSISTOR, AND SOLENOID. THE LUER CONNECTOR, TRANSISTOR, AND SOLENOID WERE REPLACED WHICH IS STANDARD PROCEDURE. THE UNIT WAS CLEANED, CALIBRATED AND TESTED TO ALL SPECS. THE ALARM WAS CHECKED AT HIGH AND LOW FLOW RATES AND PERFORMED PROPERLY. H5: TUBE SET LABELED FOR SINGLE USE; PUMP LABELED FOR MULTIPLE USE.
THE CUFF WAS REMOVED FROM THE PT, DUE TO RECURRING INCONTINENCE, AND REPLACED.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 4/14/79. PT ALSO ALLEGES HAVING REMOVAL IN 7/92 BECAUSE HER IMPLANTS RUPTURED.
CONCLUSION: NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN.
THE BALLOON WAS REMOVED FROM THE PT, DUE TO RECURRING INCONTINENCE-WRONG SIZE BALLOON, AND REPLACED.
FOUR INCHES OF THE DEVICE WAS PLACED USING A FLUSH OF NORMAL SALINE INTERMITTENTLY. IT WAS INSERTED SLOWLY AND WITHOUT DIFFICULTY WHEN THE PT COMPLAINED, "I CAN'T BREATHE GOOD AND I DON'T FEEL WELL". INSERTER ATTEMPTED TO REPOSITION PT WITH PILLOW BUT THE BREATHING DIFFICULTY CONTINUED, "THE PT APPEARED TO BE IN A LOT OF DISTRESS". THE PT THEN COMPLAINED OF A "HOT PRICKLY SENSATION ON HER BACK". THE CATHETER WAS REMOVED AND THE SYMPTOMS SUBSIDED WITHOUT FURTHER INTERVENTION.
DATE SENT TO FDA: 11/15/96. F10- CORRECTED INFO: PT CODE# 2036- INCLUDED ON LABEL.
STAFF MEMBER OBSERVED TUBING TO BE KINKED INSIDE SEALED POLYBAG. NO PT INVOLVEMENT.
UPON COMPLETION OF FAILURE INVESTIGATION. A FOLLOW UP REPORT UP REPORT WILL BE SUBMITTED.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF NON-SPECIFIC LEAD MALFUNCTION. FAILURE ANALYSIS INDICATED THAT LEAD IS FRACTURED WITHOUT PROTRUSION.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED APPROX 6MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX 68 MM AND IS LOCATED IN THE 3RD SECTION OF LEAD RECEIVED APPROX 37 MM PROXIMAL OF THE DISTAL END OF THE OUTER POLYURETHANE INSULATION WHICH SEPARATED FROM THE PROXIMAL SIDE OF THE ANODE BAND. IT APPEARS THAT APPROX 14 MM OF THE J STIFFENER WIRE WAS NOT RECEIVED WITH ALL RECORDED MEAUSREMENTS ADDING UP TO APPROX 74 MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS NIPPED OR CUT INTO 3 SECTIONS WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURES.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1984 OF AN UNKNOWN MFR. PT ALSO ALLEGES TWO YRS AFTER HER SURGERY (I.E. 1986) SHE STARTED TO EXPERIENCE DISCOMFORT, PAIN AND HARDENING OF THE BREASTS.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RUPTURE OF CYLINDER. ADD'L LOT/SER #: 9651OL 020.
THE PT REQUIRED ENDOTRACHEAL INTUBATION IN TRAUMA, RESUSCITATION UNIT FOR SEVERE HYPOTENSION, HYPOXEMIA, AND COMBATIVENESS. INTUBATION WAS ACHIEVED BUT AFTER 5-6 RESPIRATIONS WITH BAG, VENTILATION BECAME DIFFICULT. PT REINTUBATED, ONCE AGAIN AFTER SEVERAL RESPIRATIONS, VENTILATION BECAME DIFFICULT AND SUBCUTANEOUS EMPHYSEMA DEVELOPED. AIRWAY TRAUMA WAS SUSPECTED, CRICOTHYROIDOTOMY ATTEMPTED, BILATERAL CHEST TUBES PLACED. PT BECAME PULSELESS. THORACOTOMY PERFORMED. LUNGS WERE HYPERINFLAALTED. BAG REMOVED FROM TRACHEAL TUBE WITH RESOLUTION OF HYPERINFLATION. A NEW BAG WAS USED AND VENTILATION WAS NORMAL. THE FIRST BAG WAS FOUND TO HAVE A DEFECTIVE PEEP VALVE WHICH PROHIBITED EXHALATION.
ON 7/31/96 AN AUS DEVICE WAS IMPLANTED. INFO RECEIVED ON 9/27/96 INDICATES DIFFICULT ACTIVATION.
SUTURE BROKE RESULTING IN A LARGE MEDIASTINAL HEMATOMA. BLEEDING POINT DETERMINED TO BE AT THE BASE OF AORTIC CLOSURE.
ON 6/4/86 DEVICE WAS IMPLANTED. ON 10/1/96 THE PUMP WAS REVISED. ON 7/20/96 THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACTION-RECURRING INCONTINENCE, DELAYED REFILLING OF THE CUFF WITH INCONTINENCE.
PT HAD HX OF NAUSEA/VOMITTING INTERMITTENTLY WITH INCREASE SEVERITY THIS DATE. ADMITTED TO HOSP ER FOR EVAL AND NAUSEA, VOMITTING WAS TREATED WITH BENADRYL. WITHIN 5 MIN ER STAFF REPORTED SEVERE ELEVATION OF BP & HR TREATED WITH PROPRANOLOL WITH IMPROVEMENT. AFTER 1-2 HOURS PT DEVELOPED PULMONARY EDEMA. ADMITTED TO THE HOSP AFTER TREATMENT WITH IV LASIX FAILED TO RESOLVE PROBLEM. PULMONOLOGIST CONSULTED AND THEN TREATED CONSERVATIVELY 2-3 DAYS PRIOR TO VENTILATION SUPPORT. PT HAD MULTIPLE INFECTION PROBLEMS (INCLUDING PERSISTANT SUSTAINED HIGH WBC COUNT AND COUGH SEVERAL WEEKS PRIOR TO THIS EVENT). WBC WAS ELEVATED ON ADMISSION TO ER PRIOR TO PULMONARY EDEMA. PT WAS EXTUBATED ONCE FOR APPROX 2 WEEKS THEN ASPIRATED, REINTUBATED AND GRADUAL DEMISE.
PRIMARY FINDING OF DEVICE ANALYSIS REVEALED A MOTOR STALL OF THE PUMP OF UNDETERMINED ORIGIN. MFR IS UNABLE TO DETERMINE THE CAUSE OF THE MOTOR STALL DUE TO REQUEST BY THE FAMILY'S COUNSEL TO NOT PERFORM DESTRUCTIVE ANALYSIS ON THE DEVICE. NO FURTHER CONCLUSION OF THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT CAN BE DRAWN WITHOUT DESTRUCTIVE ANALYSIS OF THE DEVICE.  4/9/1998: MANUFACTURER REOPRT NUMBER HAS BEEN CORRECTED HERE AND IN HEADER.  MANUFACTURER ADDRESS LISTED.
MFR RECEIVED A REPORT OF A SEVEN YR OLD BED BEING INVOLVED IN A FIRE WHICH RESULTED IN A PT DEATH. THE FIRE INVESTIGATORS FINDINGS HAVE NOT BEEN CONFIRMED AND ARE BEING FORWARDED TO A SECOND LAB FOR EVAL.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 3/75. PT ALSO ALLEGES FOR THREE YRS (I.E. 1993) SHE HAS HAD HEALTH PROBLEMS FROM HER PROSTHESES; HOWEVER, NO SPECIFICS WERE GIVEN. ACCORDING TO HER DRS, SHE NEEDS TO BE OPERATED ON AS SOON AS POSSIBLE BECAUSE HER HEALTH IS WORSE AND WORSE DAY AFTER DAY.
INFO RECEIVED ON 1/9/97 INDICATES THIS WAS A TANDEM CUFF IMPLANT. NO COMPONENTS WERE REMOVED OR REPLACED.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1984. SHE SUSPECTS THEY MAY BE LEAKING.
A FEMALE PT WAS PRESENTED FOR A BREAST BIOPSY. THE NEEDLE WAS INSERTED INTO THE PT. THE PHYSICIAN THEN TRIED TO PLACE THE WIRE, COULD NOT PASS IT THROUGH THE HUB. SHE STATED THAT IT SEEMED AS THOUGH THE STIFFENING CANNULA WOULD NOT FIT. ANOTHER DEVICE WAS OPENED AND ONLY THE WIRE WAS USED. THE PROCEDURE WAS COMPLETED.
REVIEW OF LOT HISTORY: INVESTIGATION OF BATCH RECORDS INDICATE THE FOLLOWING: 200 PIECES WERE CHECKED AT FINAL QC FOR FIT WITH CANNULA, NO REJECTS WERE FOUND. 200 PIECES WERE CHECKED IN PROCESS TO CONFIRM THE WIRE WOULD PASS THROUGH AN .023 DIAMETER HOLE, NO FAILURES WERE FOUND. REVIEW OF RETURN SAMPLE: SAMPLE OF ACTUAL FAILED PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. CONCLUSION/FOLLOW-UP #2: NO DEFINITIVE CONCLUSIONS CAN BE REACHED BASED ON THE LIMITED EVIDENCE AVAILABLE.
IMPLANT WAS LOOSE AT THE BONE/IMPLANT INTERFACE. KNEE COMPONENT WAS ROTATED 90 DEGREES. WASHERS WERE EXCHANGED AND IMPLANT WAS REPOSITIONED ON 9/19/96.
THERE WAS WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. A FAX WAS SENT TO THE USER FACILITY ON 10/3/96. CO DID NOT RECEIVE A MEDWATCH REPORT FORM FROM THE USER FACILITY.
DURING VASCULAR SURGERY, AN AORTIC BIFEMORAL BYPASS GRAFT, THE TUNNELER TIP OF THE INSTRUMENT USED BY THE SURGEON CAME OFF WHILE STILL IN THE PT. IT TOOK 4 HRS TO LOCATE THE TIP USING X-RAY AND EXPLORATION. THE SURGERY TIME WAS EXTENDED. THE PT REQUIRED REOPERATION TWO DAYS LATER AND EXPIRED ON 10/14/96.
HOSP HAS STATED IT WILL NOT RETURN DEVICE TO THE MFR FOR EVAL. WITHOUT EVALUATING THE ACTUAL DEVICE INVOLVED IN THE REPORT, CO PERSONNEL CANNOT CONFIRM REPORT OR ASSESS DEVICE.
A CUFF WAS IMPLANTED DUE TO RECURRING INCONTINENCE. NO COMPONENTS WERE REMOVED OR REPLACED.
DEVICE INSERTED INTO LEFT BASILIC VEIN OF AN APPREHENSIVE PT WHO THEN DEVELOPED A RAISED RASH IN THE UPPER ARMS, HEAD AND LOWER LEGS WITH FACIAL FLUSHING AND HANDS TURNED PURPLE. THERE WAS NO SHORTNESS OF BREATH. PT'S HEARTRATE WENT FROM 64 TO 98, B/P 154/78, REPIRATIONS-28. BENADRYL 50MG PO GIVEN TO THE PT. APPROX ONE HOUR AFTER DEVICE WAS INSERTED, PT'S SYMPTOMS BEGAN TO SUBSIDE. PT WAS DISCHARGED TO HOME THE NEXT DAY WITH THE DEVICE IN PLACE.
DATE SENT TO FDA: 12/06/96. CODE 2200 - ON LABEL.
PT ALLEGES RECEIVING BREAST IMPLANTS ON AN UNKNOWN DATE. PT ALSO ALLEGES SHE HAS HAD AT LEAST SIX PAIRS OF CO IMPLANTS INSERTED AND NOW SHE IS SURE ONE HAS RUPTURED. SHE IS NOW DISABLED AND IN A WHEELCHAIR, BECAUSE SHE HAS TROUBLE WALKING AND IS IN CONSTANT PAIN. PT WOULD LIKE HER IMPLANTS REMOVED AND NEW ONES INSERTED.
PT HAD A LEFT TOTAL KNEE REPLACEMENT ON 2/22/91 AND DEVELOPED A FAIRLY SUDDEN VALGUS ANGULATION OF THE KNEE AND A SCRAPING TYPE FEELING. IT WAS DETERMINED THAT THE TIBIAL POLY COMPONENT FAILED AND THE DEVICE WAS EXPLANTED ON 9/13/96. ITS FAILURE TO MEET EXPECTATIONS RESULTED IN A SECOND SURGICAL PROCEDURE AND PROLONGED HOSPITALIZATION FOR THE PT.
COLD KNIFE BLADE BROKE DURING PROCEDURE; PART OF BROKEN BLADE NOT FOUND; X-RAY AND CYSTOSCOPY PROCEDURES FAILED TO FIND MISSING PIECE.
EXCESSIVE FORCE WAS APPLIED LATERALLY TO THE LEFT SIDE OF THE DISTAL TIP OF THE BLADE, CAUSING THE FRACTURE AND THE SEPARATION.
ABUTMENT SCREWS HAVE FRACTURED INSIDE OF IMPLANTS. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREWS FROM THE IMPLANTS. THE IMPLANTS ARE STILL IN THE PT'S MOUNTH. PT INJURY IS NOT REPORTED.
BIOMECHANICAL FAILURE DUE TO REMOVAL OF LOOSE BRIDGEWORK.
HOSP EXPERIENCED DIFFICULTY IN PASSING TELESCOPES THROUGH TIGHT CHANNELS.
PHYSICIAN SENT PHOTOGRAPHS OF PT'S EXPLANTS TO CO FOR IDENTIFICATION PURPOSES. A PHOTOGRAPHIC EVAL APPEARS TO INDICATE LOSS OF SHELL INTEGRITY.
PT HAD A LEFT TOTAL KNEE REPLACEMENT ON 2/22/91 AND DEVELOPED A FAIRLY SUDDEN VALGUS ANGULATION OF THE KNEE AND A SCRAPING TYPE FEELING. IT WAS DETERMINED THAT ALLEGEDLY THE TIBIAL POLY COMPONENT FAILED AND THE DEVICE WAS EXPLANTED ON 9/13/96. IT'S FAILURE TO MEET EXPECTATIONS RESULTS IN A SECOND SURGICAL PROCEDURE AND PROLONGED HOSPITALIZATION FOR THE PT.
THE DEVICE WAS USED DURING A RIGHT LOBECTOMY. ON THE FIRST FIRING THERE WAS STAPLE LINE BLEEDING. THE STAPLE LINE WAS OVERSEWN TO CONTROL THE BLEEDING. THERE WAS NO BUTTRESSING USED. A NEW RELOAD WAS PUT IN THE INSTRUMENT AND IT WORKED FINE. THE PT RECEIVED ONE UNIT OF BLOOD DURING THE PROCEDURE. 10/18/96 DR WAS PERFORMING A LOBECTOMY AND HE WAS USING THE DEVICE ON THE INFERIOR PULMONARY VEIN. THE INITIAL FIRING WAS NEXT TO THE ATRIUM AND A SECOND FIRING WAS PLACED TOWARD THE LUNG TISSUE BEING RESECTED. INITIAL INSPECTION PRIOR TO DIVIDING THE VESSEL REVEALED NO PROBLEM WITH THE STAPLE LINE. HOWEVER, WHEN THE VESSEL WAS DIVIDED THE STAPLE LINE DID NOT HOLD. CONTROL WAS OBTAINED AND SUTURES WERE USED TO REPAIR THE FAILED STAPLE LINE. THE INSTRUMENT IS BEING RETURNED FOR CO'S EVALUATION. THERE ARE NO PHOTOS OR STAPLES TO BE RETURNED. THE PT REQUIRED 1 UNIT OF BLOOD AND HAS RECOVERED WITH NO SEQUELAE ANTICIPATED.
BASED ON THE INFO REC'D AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS FIRED AND FORMED STAPLES AS DESIGNED ACROSS THE ENTIRE STAPLE LINE. THE STAPLE HEIGHTS AND STAPLE FORMATION WERE CONFORMING WITH RESPECT TO MFG REQUIREMENTS. THEREFORE, IT COULD NOT BE ASCERTAINED AS TO WHY THE STAPLE LINE REPORTEDLY BLED. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
REVISION SURGERY PERFORMED DUE TO CUP ECCENTRICITY DUE TO POLY WEAR AND ALLEGED OSTEOLYSIS AROUND THE ACETABULUM. WEAR WAS FOUND AT THE REVISION SURGERY.
CONCLUSION STATEMENT. NO DEVICE FAILURE.
H3- THE RIGHT IMPLANT WAS SENT TO CO FOR IDENTIFICATION PURPOSES ONLY AND THEN RETURNED ON 9/27/96 WITHOUT FURTHER EVAL.
PHYSICIAN'S NOTE STATES CONCERN REGARDING LEAKAGE, BREAST PAIN AND CAPSULAR CONTRACTION.
PT FOUND EXTUBATED. ONE LIMB RESTRAINT (WRIST) OFF PT.
REPORTER ALLEGES PT RECEIVED IMPLANT 10 YRS AGO (I.E. 1986) FROM AN UNKNOWN MFR. REPORTER ALSO ALLEGES "PT HAS BEEN SUFFERING FROM MANY SEQUELA SINCE SHE WAS OPERATED FOR AUGMENTATION 10 YRS AGO", NO OTHER SPECIFICS WERE STATED.
H3-AVAILABILITY OF DEVICE IS UNKNOWN AT THIS TIME.
DURING THE INSERTION OF A MIDLINE IV CATHETER A PT COMPLAINED OF BEING "SICK TO MY STOMACH", HE THEN BECAME ASHEN AND DIAPHORETIC. THE CLINICIAN REPORTED THAT THE PT THEN "FAINTED". SHE HAD DIFFICULTY PALPATING A PULSE HIS BLOOD PRESSURE WAS NOT AUDIBLE BUT COULD BE PALPATED (THERE IS NO NUMBER AVAILABLE). THE CLINICIAN COMPLETED THE INSERTION OF THE CATHETER USING THE "FLOAT IN" TECHNIQUE. IT WAS CONSIDERED AN "EASY INSERTION". THE CLINCIAN THEN USED AN AMMONIA CAPSULE TO "REVIVE" THE PT. SHE NOTIFIED THE PHYSICIAN OF THE INCIDENT. NO MEDICAL TREATMENT WAS ORDERED. THE CATHETER WAS LEFT IN PLACE. THE CLINICIAN STATED THAT THIS WAS DIAGNOSED AS A "VASOVAGAL" RESPONSE.
DATE SENT TO FDA: 10/25/96. B4- DATE RECEIVED BY THE MFR. F8- DATE RECEIVED BY THE MFR. CO HAS DECIDED TO DISCONTINUE MANUFACTURE AND SALE OF THE CATHETER AND OTHER BRANDS OF IV CATHETER AS OF 9/18/96. EVALUATION CONCLUSION: IN SPITE OF RESEARCH DONE TO DATE, CO HAS NOT BEEN ABLE TO ESTABLISH CAUSALITY FOR THE TYPE OF EVENT REPORTED. CO WILL CONTINUE TO TRACK THIS TYPE OF INFO AS IT IS IMPORTANT TO CO'S PRODUCT IMPROVEMENT AND DEVELOPEMENT PROCESS.
PLATE WAS IMPLANTED 5/1/96, AT THIS FACILITY. NONUNION/MALUNION. LT DISTAL MID FEMUR FRACTURE JUST AT LEVEL OF TOTAL HIP ATHROPLASTY. DELAYED HEALING MID SHAFT FEMUR FRACTURES, POST OPEN REDUCTION INTERNAL FIXATION. 9/19/96, COMPLEX OPEN REDUCTION INTERNAL FIXATION WITH TRACK CUSTOM FRACTURE PLATE WITH MULTIPLE WIRES AND SCREWS. ANOTHER CO'S BONEGRAFT ADDED WITH BONE GRAFTING AS WELL AS ONE FEMORAL ALLOGRAFT HEAD REMOVAL DEEP HARDWARE, MULTIPLE WIRES AND PLATES. THE OLD PLATE WAS BROKEN.
PT HAD CARDIO-PULMONARY ARREST. DURING ATTEMPTS TO RESUSCITATE, DEFIBRILLATOR WOULD NOT CHARGE OR DELIVER SHOCK TO PT. CODE WAS NOT SUCCESSFUL.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL.
INFORMATION RECEIVED ON 11/06/96 INDICATES THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 11/1/96.
DURING ENDOSCOPIC CARPAL TUNNEL RELEASE LACERATION OF MAJOR NERVES OCCURRED.
CO WAS NOTIFIED OF A LAW SUIT PENDING WHICH SUGGESTS THAT CO'S PRODUCT WAS INVOLVED IN AN INCIDENT WHERE MAJOR NERVES WERE LACERATED DURING CARPAL TUNNEL SURGERY. NO MALFUNCTION OF THE DEVICE INVOLVED WAS REPORTED. NONE OF THE DETAILS PERTAINING TO THE PRODUCT INVOLVED WERE LISTED. A SEARCH OF THE PURCHASE ORDER RECORDS FROM THIS FACILITY SHOWS THAT THE HOSP IN QUESTION HAS ONLY EVER PURCHASED THESE DEVICES FROM CO . THESE DEVICES WERE PURCHASED IN EARLY 1992. A REVIEW OF CO'S COMPLAINT FILES INDICATES NO REPORTS PERTAINING TO THIS INCIDENT WERE FILED AT THE TIME. SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW ENDOSCOPY WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT AS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW ENDOSCOPY, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BYT FDA, SMITH & NEPHEW ENDOSCOPY, OR IT'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS EVENT.
REPORTER ALLEGES PT RECEIVED IMPLANTS ON AN UNKNOWN DATE. REPORTER ALSO ALLEGES PT HAD BAKER GRADE II-III CAPSULAR CONTRACTURE BILATERALLY; THEREFORE, SHE HAD REMOVAL ON AN UNKNOWN DATE. PHYSICIAN'S NOTE STATES LEFT IMPLANT WAS RUPTURED BY CAUTERY.
METHODS: 86B MEASUREMENT. RESULTS: 100B - CREASE LINE. 100H - LOSS OF SHELL INTEGRITY, EVELOPE TEAR. 100I - WEIGHT LESS THAN SPECIFIED. 100P - WEIGHT MEASUREMENT. 100R - INTACT WITH FULL SHELL INTEGRITY. CONCLUSIONS: 68D - CREASES AND WEAR RESULT OF FOLDING ACTION IN-VIVO. 68H - GEL NOT ALL RETURNED. 68J - WEIGHT WITHIN SPECIFICATION LIMITS.
ATTORNEY ALLEGATION RECEIVED OF J RETENTION WIRE RELATED TO PT'S DEATH. NO CONFIRMATION WAS OBTAINED FROM MEDICAL PROFESSIONAL.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS FROM THE CUFF.
PUMP PERFORMED WITHIN SPECIFICATIONS. CUFF HAD A WEAR LEAK. BALLOON PERFORMED WITHIN SPECIFICATIONS.
THE PHYSICIAN WAS ATTEMPTING TO EMBOLIZE A CYSTIC FIBROSIS IN THE RIGHT LOBE OF THE LUNG VIA THE PULMONARY CIRCULATION, THE DEVICE WAS UTILIZED AS THE DELIVERY DEVICE. TWO OCCLUDING SPRING EMBOLIC COILS WERE SUCCESSFULLY DELIVERED USING AN UNIDENTIFIED GUIDEWIRE/PUSHER DEVICE TO ADVANCE THE COILS THROUGH THE MICROCATHETER. FOLLOWING THE PROCEDURE THE DEVICE RADIOPAQUE TIP MARKER WAS NOTED UNDER FLUOROSCOPY AS DETACHED FROM THE MICROCATHETER AND MIGRATED DOWN THE VESSEL DISTAL TO THE COILS. THE PHYSICIAN CONTINUED TO USE THE DAMAGED DEVICE TO DELIVER POLYMERIC EMBOLICS TO COMPLETE THE CASE. HE THEN MOVED THE DEVICE INTO THE LEFT LOBE TO CONTINUE TREATMENT. WHILE ATTEMPTING TO ADVANCE ANOTHER COIL THROUGH THE DEVICE THE PHYSICIAN DISCOVERED THAT THE EMBOLIC PARTICLES HAD CLOGGED THE DISTAL TIP OF THE DEVICE WITHIN THE DAMAGED REGION WHERE THE MARKER HAD DETACHED. THE MARKER REMAINS IMPLANTED WITHIN THE PT'S PULMONARY VESSEL AND HAS CONTRIBUTED AN UNEXPECTED THERAPEUTIC EFFECT TO THE CYSTIC FIBROSIS. THERE WAS NO EVIDENCE OF PT INJURY OR ADVERSE EFFECT.
THE CONNECTOR WAS REMOVED FROM THE PT AND REPLACED DUE TO AIR BUBBLES IN PUMP.
PT WAS SKIN TESTED IN 9/96 (EXACT DATE UNKNOWN) AND WAS TREATED ON 10/1/96 IN THE NASOLABIAL FOLDS AND UPPER LIP. ON 10/3/96, REDNESS AND SWELLING WERE NOTED AT THE NASOLABIAL TRETAMENT SITES AND SKIN TEST SITE. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY; INTRAMUSCULAR HYDROCORTISONE WAS PRESCRIBED.
FOLLOW UP INFO RECEIVED ON 10/16/97 WAS THAT THE SYMPOMS RESOLVED AT THE END OF 1996.
DEVICE WAS IMPLANTED IN 4/96. REVISION SURGERY WAS PERFORMED ON 9/19/96, DUE TO FRACTURE OF CABLE PLATE.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT HIS TYPE OF EVENT CAN OCCUR. THIS TYPE OF EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. A FAX WAS SENT ON 10/3/96, TO THE USER FACILITY.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS AND AIR IN THE PUMP.
A 90 Y O TAKEN TO OR FOR REPAIR OF FX L HIP (FEMORAL NECK FX). PT GIVEN SPINAL ANESTHESIA. WHEN CEMENT IN CENTRIFUGE PT EXPERIENCED SUDDEN HYPOTENSION AND RESUSCITATED (INTUBATED, ETC). OPERATIVE PROCEDURE CONTINUED. PT'S BP WENT UP AFTER 15 MIN AND TAKEN TO PACU WHERE BP AGAIN DROPPED (PALPABLE 50). VASOPRESSORS/TRANSFUSIONS/INTUBATION/ETC CONTINUED AND PT TRANSFERRED TO ICU AFTER APPROX 3 1/2 HRS (9A - 12:30 PM). AFTER A COUPLE HRS IN ICU FAMILY INFORMED OF POOR PROGNOSIS AND ELECTED TO REMOVE LIFE SUPPORT AND PT EXPIRED 3:30 P 8/27.
THE CUFF WAS IMPLANTED SOMETIME PRIOR TO 10/5/84. ON 10/5/84 THE PUMP AND BALLOON WERE IMPLANTED  (2ND STAGE). ON 9/17/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
PUMP WAS FUNCTIONAL. CUFF HAD A WEAR LEAK. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS.
DURING A PT TREATMENT, THE BLOOD PUMP STOPPED, THE TOUCH SCREEN WOULD NOT RESPOND, AND THE VIDEO DISPLAY WAS NOT UPDATING. STAFF ALLEGED THAT NO ALARM OCCURRED ON THE MACHINE. WHEN STAFF DISCOVERED THAT THE BLOOD PUMP HAD STOPPED, THE DIALYZER WAS CLOTTED. STAFF WAS UNABLE TO RETURN THE EXTRACORPOREAL BLOOD TO THE PT BECAUSE OF THE CLOTTING. STEFF ESTIMATED THE BLOOD LOSS AT 300 ML. THE PT SUFFERED NO ILL EFFECTS AND REQUIRED NO MEDICAL INTERVENTION.
EVAL SUMMARY: THE DEVICE WAS EVALUATED AT THE FACILITY BY A SERVICE REP FROM THE MFR. THE SERVICE REP WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM AND THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATIONS AND OPERATING AS INTENDED. THE MAIN PROCESSOR PC BOARD ON THE DEVICE WAS REPLACED AND RETURNED TO THE MFR FOR EVAL. DURING IN HOUSE TESTING OF THE MAIN PROCESSOR PC BOARD, THE EVALUATOR WAS UNABLE TO DUPLICATE THE REPORTED FAILURE, AND THIS COMPONENT WAS FOUND TO BE WITHIN SPECIFICATIONS AND OPERATING AS INTENDED.
ON 2/13/89 AN AUS DEVICE WAS IMPLANTED. ON 4/4/90, THE BALLOON WAS REVISED. ON 9/17/96, THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE-IMCOMPLETE CLOSURE OF CUFF.
ON 7/2/92 DEVICE WAS IMPLANTED. ON 5/5/94 THE CYLINDERS WERE REVISED. ON 9/17/96 THE DEVICE WAS REMOVED FROM THE PT DUE TO A FRACTURED PENILE IMPLANT CYLINDER.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE THE PT WAS UNABLE TO OPERATE THE PUMP.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-BALLOON.
PUMP PERFORMED WITHIN SPECS. TUBING HAD OR DAMAGE. CYLINDER WAS FUNCTIONAL.RESERVOIR HAD A WEAR LEAK.
ORIGINAL SURGERY WAS PERFORMED ON 9/6/90. REVISION SURGERY WAS PERFORMED ON 8/6/96, DUE TO POLYETHYLENE WEAR.
THERE ARE WARNING IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT. A FAX WAS SENT TO THE USER FACILITY ON 9/27/96. CO DID NOT RECEIVE A MEDWATCH REPORT FROM THE USER FACILITY
ON 7/17/96 DEVICE WAS IMPLANTED. ON 7/21/96 THE CUFF WAS REVISED. ON 8/29/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION AND EROSION.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECS. BALLOON PRESSURE NOT WITHIN SPECS.
CYLINDER HAD A WEAR LEAK.  CYLINDER HAD OR DAMAGE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION - PT DID NOT UNDERSTAND HOW TO WORK THE DEVICE. THE PT KEPT THE DEVICE HALF INFLATED, WHICH CAUSED HIM PAIN. PT WANTED THE DEVICE REMOVED.
PUMP PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. TUBING HAD OR DAMAGE.
ON 9/24/96, THE MFR RECEIVED INFO FROM ITS DISTRIBUTOR THAT A FACILITY IN THEIR TERRITORY EXPERIENCED DIFFICULTIES WITH THE DEVICE. THE REPORT STATES THAT THE NEEDLE DID NOT PUNCTURE SMOOTHLY. IN ADDITION, THE PT EXPERIENCED PAIN AND FELT A HOOK AT THE TIP OF THE NEEDLE. AN UNUSED SAMPLE IS EXPECTED TO BE RETURNED TO THE MFR FOR EVALUATION.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: THE DEVICE WAS RECEIVED IN THE ORIGINAL OPENED PACKAGE. MICROSCOPIC EVALUATION OF THE NEEDLE INCLUDING THE NEEDLE TIP SHOWED NO ANOMALIES. BURRS OR BENDS WERE NOT SEEN ON THE NEEDLE TIP. THE FLOW PATH OF THE NEEDLE APPEARED CLEAN AND OPEN AND THE NEEDLE WAS PATENT. A TEST SEPTA WAS USED TO PUNCTURE TEST THIS NEEDLE. THE NEEDLE PUNCTURED THE SEPTA SMOOTHLY AND DID NOT INTRODUCE DAMAGE TO THE SEPTA AFTER SEVERAL PUNCTURES. ANOMALIES NOT FOUND. AS PART OF INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORDS AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MANUFACTURING VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. BASED ON THE INFO AVAILABLE, AND THE DEVICE ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT. UNDER B4 DATE OF REPORT WAS INCORRECTLY REPORTED AS 10/23/96. CORRECT DATE OF THIS REPORT IS 9/24/96. UNDER F8, DATE OF THIS REPORT WAS INCORRECTLY REPORTED AS 10/23/96. CORRECT DATE OF THIS REPORT IS 9/24/96. MFR IS NOW CLOSING FILE ON THIS EVENT.
AN AUS DEVICE WAS IMPLANTED ON 7/10/89. THE PUMP WAS REVISED ON 8/7/89. THE ENTIRE DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS, ON 9/17/96 AND REPLACED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS - RESERVOIR.
DEVICE WAS REMOVED FROM THE PT, DUE TO INFECTION, AND REPLACED.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO CYLINDER FAILURE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-ENTIRE SYSTEM.
ON 6/8/83, DEVICE WAS IMPLANTED. ON 2/19/86, THE CYLINDERS AND PUMP WERE REVISED. ON 9/17/96, THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-LEAK, LT PENILE TUBE, TWO PINHOLES.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO PERI-URETHRAL TISSUE ATROPHY.
THE IPP DEVICE WAS REMOVED FROM THE PT DUE TO A "FAILED PROSTHESIS." ANOTHER WAS IMPLANTED. ADD'L INFO RECEIVED ON 11/4/96 INDICATES REASON AS "BLOWN OUTER LINING."
SURGEON QUESTIONED IF PRODUCT COULD HAVE CONTRIBUTED TO DEATH.
ON 9/27/96, A FACILITY NURSE CONTACTED THE MFR'S CLINICAL REP. THE FACILITY NURSE STATED THAT THE PT WAS AT THE HOME HEALTH AGENCY FOR A URINALYSIS AND WAS COMPLAINING OF PAIN IN THE LEFT FLANK. THE FACILITY NURSE STATED THAT THE PT'S INCISION WAS NOTED TO BE RED, HOT AND SWOLLEN. ADDITIONALLY, THE FACILITY NURSE STATED THAT THE AREA ON THE RIGHT, WHICH IS ALSO THE SIDE WHERE THE DEVICE IS LOCATED, WAS NOTED TO BE SWOLLEN DOWN TO THE PT'S RIGHT GROIN AREA. THE PT HAD NO ELEVATION IN TEMPERATURE. THE PHYSICIAN WAS TO ADMIT THE PT TO THE HOSP WHERE HE WOULD BE EVALUATED.
ON 10/08/96, THE FACILITY'S OFFICE MGR INFORMED THE MFR'S REP THAT THE PT WAS HOSPITALIZED FOR A 24 HR PERIOD, AND WAS PRESENTLY AT HOME. THE PT HAS BEEN SEEN EVERY DAY SINCE BY ONE OF THE PHYSICIANS. THE FACILITY'S OFFICE MGR UNDERSTANDING IS, THAT IT WAS FELT THAT THERE WAS NICKING OF THE HEPATIC ARTERY, EITHER DURING THE IMPLANT OF THE DEVICE OR DURING ONE OF THE DEVICE INFUSIONS( PT IS REFILLED BY ANOTHER FACILITY). TO THE FACILITY'S OFFICE MANAGER'S KNOWLEDGE, THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. SINCE THE DEVICE REMAINS IMPLANTED AND A SERIAL NUMBER WAS NOT PROVIDED FOR THE DEVICE, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. BASED ON THE INFO AVAILABLE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT; HOWEVER, THE FACILITY'S OFFICE MANAGER'S UNDERSTANDING IS, THAT IT WAS FELT THAT THERE WAS NICKING OF THE HEPATIC ARTERY, EITHER DURING IMPLANT OR DURING ONE OF THE DEVICE INFUSIONS/REFILLS. THE DEVICE REMAINS IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. THE CUSTOMER WILL BE NOTIFIED OF CO'S FINDINGS. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
FOUR HRS POST-OP AND X-RAY OF "R" KNEE OBTAINED WITH OBVIOUS PIECE OF SCREW FROM INSTRUMENTATION, THAT IS THE FEMORAL JIG, HAD FALLEN INTO HER KNEE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SERNO: CD995 003.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO URETHRAL EROSION.
ON 11/27/90 AN AUS DEVICE WAS IMPLANTED. ON 5/11/93 THE CUFF WAS REVISED. ON 9/18/96, THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO MALFUNCTION.
THE RT CYLINDER WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE, FLUID LOSS, AND PT DISSATISFACTION-AND REPLACED.
THE CYLINDERS WERE REMOVED FROM THE PT, DUE TO AN ANEURYSMAL DILATION OF THE LEFT PROXIMAL CORPORA, AND REPLACED.
INFORMATION RECEIVED ON 10/25/96 INDICATES REASON AS FLUID LOSS AT LEFT CYLINDER.
SURGERY WAS PERFORMED ON 8/13/96. POST OPERATIVE X-RAY INDICATED THAT A SET SCREW WAS LEFT IN PT. THE SET SCREW WAS RETRIEVED FORMT HE PT ON THE SAME DAY.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. A FAX WAS SENT TO THE USER FACILITY ON 10/3/96. CO RECEIVED A MEDWATCH REPORT FORM FROM THE USER FACILITY ON 10/10/96.
DEVICE WAS REMOVED FROM THE PT, DUE TO BUCKLING OF RIGHT CYLINDER, AND REPLACED. UNABLE TO OBTAIN ADD'L INFO.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CUFF AND PUMP.
DURING LAPORASCOPIC PROCEDURE A TROCAR BROKE WHILE INSIDE THE ABDOMINAL CAVITY. REMOVAL OF THE PIECES REQUIRED ADD'L SURGERY. THE PT WAS THEN PLACED IN ICU. DURING INSPECTION OF THE BROKEN INSTRUMENT IT WAS DISCOVERED THAT THERE WERE STILL PIECES MISSING.
DEVICE WAS IMPLANTED, DATE NOT INDICATED. THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO MECHANICAL FAILURE.
DEVICE WAS RREMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO INFECTION AND MALFUNCTION OF CYLINDER.
ON 9/1/92 DEVICE WAS IMPLANTED. 7/2/95 THE CYLINDERS WERE REVISED. ON 10/27/95 THE TUBING WAS REPOSITIONED DUE TO MALPOSITION.
THE DEVICE WAS IMPLANTED ON 4/20/95, FOR THE INTRATHECAL INFUSION OF MORPHINE FOR TREATMENT OF PAIN (NOTE: INTRATHECAL INFUSION OF MORPHINE WAS NOT A MFR'S INDICATION FOR THE DEVICE'S INTENDED USE). ON 9/30/96, THE FACILITY NURSE CONTACTED A MFR CLINICAL REP AND STATED THAT IN EARLY SEPTEMBER 1996, THE PT HAD FEVER, CHILLS WAS DIAGNOSED WITH PNEUMONIA AND TREATED WITH ANTIBIOTICS. ON 9/26/96, THE PT STARTED TO EXPERIENCE "SEVERE ITCHING". THE PT WAS HOSPITALIZED FOR ITCHING AND INTRATHECAL PAIN CONTROL. ON 9/30/96, PT WAS SCHEDULED FOR A CHECK OF CATHETER PLACEMENT VIA THE DEVICE SIDEPORT WITH FLUORO. THE MFR CLINICAL REP ALSO INFORMED THE FACILITY NURSE THAT IF CATHETER PLACEMENT WAS "OK", THEY WOULD WANT TO RULE OUT MENINGITIS, EMPTY THE DEVICE, RINSE THE DEVICE WITH NORMAL SALINE TWO TIMES (2X), REFILL THE DEVICE WITH 50CC'S NORMAL SALINE AND MEDICATE FOR PAIN VIA ANOTHER ROUTE. THE FACILITY NURSE STATED THAT DURING THE DEVICE REFILL, THE RETURN VOLUME = 16CC, THE CALCULATED FLOW RATE (FR) OF THE DEVICE = 0.829ML/DAY AND THE REFILL PERIOD = 41 DAYS AND THE DEVICE WAS REFILLED WITH 50CC. THE DEVICE PREDICTED FR IS 0.97 ML/DAY. THE FACILTY NURSE STATED THAT THEY ARE JUST CHECKING TO SEE IF THEY WERE CALCULATING THE DEVICE FR PROPERLY AND IF THE MFR KNEW WHAT MIGHT CAUSE THE ITCHING THE PT WAS EXPERIENCING SINCE THERE WAS NO PREVIOUS REPORT OF ITCHING. ON  10/4/96, THE FACILITY NURSE INFORMED A MFR REP THAT A DYE STUDY WAS PERFORMED WHICH DID NOT REVEAL ANY ANOMALIES AND THE DEVICE IS FUNCTIONING WELL. PT HAS MULTIPLE ALLERGIES; HOWEVER, THE FACILITY NURSE WAS NOT SPECIFIC AS TO WHAT THE PT WAS ALLERGIC TO.
ON 10/4/96, THE FACILTITY NURSE INFORMED A MFR REP THAT THE DYE STUDY DID NOT REVEAL ANY ANOMALIES AND THE DEVICE IS FUCNTIONING WELL. ADDITIONALLY SHE STATED THAT THE PT WAS GIVEN A LOT OF VARIOUS MEDICATIONS (MEDICATIONS GIVEN WERE NOT SPECIFIED) OVER A 30 DAY PERIOD AND THE PT HAS MULTIPLE ALLERGIES. ALSO SHE STATED THAT THE PT'S ITCHING WAS TREATED WITH STERIODS AND BENADRYL, THE PT HAS IMPROVED AND THE INTCHING HAS SUBSIDED. THE PT WAS GIVEN A CHOICE OF ORAL NARCOTICS; HOWEVER, SHE REFUSED. THERE WAS NO MALFUNCTION OF THE DEVICE, THE DEVICE IS FUNCTIONING WELL AND WILL REMAIN IMPLANTED FOR CONTIMUED USE IN THE PT'S THERAPY REGIMEN. THE PROBLEM HAS BEEN RESOLVED AND SHE SEES NO REASON TO KEEP THIS FILE OPEN ANY LONGER. SINCE THE DEVICE REMAINS IMPLANTED, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDNETS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING AVRIANCES RELATED TO THIS EVENT FOR THIS DEVICE. IN CONCLUSION, BASED ON THE INFO AVAILABLE, THIS EVENT APPEARS TO BE ATTRIBUTABLE TO THE PT RECEIVING A LOT OF DIFFERENT MEDICATIONS OVER A 30 DAY PERIOD AND TO THE PT HAVING MULTIPLE ALLERGIES, NOT DUE TO THE DEVICE OR A DEVICE MALFUNCTION. ALTHOUGH NOT PART OF THE MFR'S ORIGINAL OCTOBER 1992 DEVICE SAFETY ALERT, INSTRUCTIONS PROVIDED IN THE ALERT GUIDELINES APPLY TO THIS DEVICE. NO FURTHER DETAILS ARE AVAILABLE. THE CUSTOMER WILL BE NOTIFIED OF CO'S FINDINGS. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
STEAM ESCAPED WHEN DOOR OF STERILIZER WAS OPENED FOLLOWING A STERILIZATION CYCLE CONSISTING OF 3 MINS GRAVITY. STAFF MEMBER'S FACE BURNED. INDIVIDUAL WAS TREATED IN EMERGENCY DEPT FOR FIRST DEGREE BURNS OF FACE AND RELEASED THE SAME DAY. A CORNEAL BURN WAS FOUND ON SUBSEQUENT EXAMINATION.
INFORMATION ACQUIRED ON 10/31/96 INDICATES THE DEVICE WAS REMOVED DUE TO INFECTION, DATE NOT INDICATED. NO DEVICE WAS IMPLANTED AT THAT TIME.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION AND INFECTION.
PUMP PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS. CUFF HAD OR DAMAGE.
A MALLEABLE DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. AN IPP DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO. INFO ACQUIRED ON 11/4/96 INDICATES REASON AS PT DISCOMFORT-HURTS WIFE.
DEVICE WAS REMOVED FROM THE PT, WOULD NOT INFLATE, AND REPLACED. ADD'L LOT/SER NO: 3727J 009.
ON 9/21/84 DEVICE WAS IMPLANTED. A CONNECTOR WAS REVISED ON 8/18/96, DUE TO FLUID LOSS, AND REPLACED.
ON 10/2/06, THE FACILITY'S PURCHASING AGENT INFORMED THE MFR'S CUSTOMER SERVICE REP THAT THE DEVICE DID NOT ASPIRATE WHEN IT WAS CONNECTED TO THE CATHETER. ANOTHER DEVICE OF THE SAME CATALOG/LOT NUMBER WAS OPENED AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. IT WAS FELT THAT THE DEVICE WAS DEFECTIVE.
THE DEVICE WAS RETURNED TO THE MFR ON 10/7/96, AND HAS BEEN ANALYZED AS FOOLLOWS: THE DEVICE CATHETER WAS NOT RETURNED WITH THE DEVICE. THE DEVICE BODY INCLUDING THE SEPTUM MATERIAL APPEARED ANOMALY FREE. THE EXPOSED METAL CONNECTOR WAS FREE METALLURGIC DEFECTS, BENDS OR OBSTRUCTION. THIS UNIT WAS PATENT AS RECEIVED WITH NO RESISTANCE FELT WHEN FLUSHING. PRESSURE TESTING OF THE UNIT WAS LEAK TIGHT WHEN APPLYING 60PSI OF AIR AND FLUID. THE DEVICE PERFORMED AS INTENDED DURING THE MFR'S ANALYSIS. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG/LOT NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING VARIANCES RELATED TO THIS EVENT. IN CONCLUSION, BASED ON THE INFO AVAILABLE AND THE RESULTS OF THE MFR'S ANALYSIS, THE COMPLAINT THAT "THE DEVICE DID NOT ASPIRATE" COULD NOT BE CONFIRMED; THEREFORE, NO CONLCUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE CUSTOMER WILL NE NOTIFIED OF THE MFR'S FINDINGS. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
DEVICE WAS REMOVED ROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO PT DISSATISFACITON.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT , DUE TO FLUID LOSS AT PUMP TUBING, AND REPLACED.
PUMP HAD A FATIGUE LEAK. CYLINDER PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS.
PT REPORTS "PIMPLES" THAT ARE APPEARING ON THE SHAFT ON HIS PENIS--DEVICE NO LONGER INFLATES, OR HOLDS ERECTION LIKE IT USED TO.
PT REPORTS "PIMPLES" THAT ARE APPEARING ON THE SHAFT OF HIS PENIS-DEVICE NO LONGER INFLATES, OR HOLDS, ERECTION LIKE IT USED TO.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO MALFUNCTION OF CYLINDER.
DEVICE WAS REMOVED FROM THE PT, DUE TO INADEQUATE RIGIDITY, AND REPLACED. ADD'L LOT SER #: 6657L 012.
THE DEVICE WAS IMPLANTED ON 12/20/90, FOR INFUSION OF MORPHINE FOR TREATMENT OF PAIN. ON 9/27/96, THE FACILITY'S ANESTHESIOLOGIST INFORMED THE MANUFACTURE'S SALES REP THAT THE DEVICE WAS REFILLED ON 9/19/96. AFTER THE DEVICE WAS REFILLED THE PT STARTED TO "ACT CRAZY". THE PHYSICIAN SUSPECTED A DEVICE MALFUNCTION. ON 9/20/96, THE DEVICE WAS EMPTIED WITH A RETURN VOLUME OF ONLY 30CC. A DYE STUDY WAS PERFORMED AND REVEALED CONTRAST COMING OUT OF THE DEVICE CENTER SEPTUM. THE DEVICE WAS EXPLANTED AND REPLACED ON 9/27/96.
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND HAS BEEN ANALYZED AS FOLLOWS: NORMAL USAGE WAS SEEN ON THE DEVICE CENTER AND DEVICE SEPTA. NO INTERNAL FRACTURE PLANE DAMAGE WAS SEEN. THE DEVICE DID NOT LEAK WHEN PRESSURIZING THE DEVICE OR FILLING THE RESERVOIR. THE DEVICE WAS PATENT UPON FLUSHING AND APPROX 5 MLS OF CLEAR, COLORLESS, PARTICLE FREE FLUID, WHICH TESTED POSITIVE FOR BLOOD WAS COLLECTED. THE DEVICE FLOWED WITHIN ORIGINAL MANUFACTURER FLOW RATE SPECIFICATIONS AS RECEIVED. THE DEVICE  FLOWED 89% OF THE EXPECTED FLOW RATE AFTER REMOVING THE DEVICE CAPILLARY TUBING FROM THE DEVICE INLET TUBE, AND FLOWED 95% OF THE EXPECTED FLOW RATE AFTER REMOVING APPROX 1" OF THE CAPILLARY TUBING. MICROSCOPIC EXAMINATION REVEALED THAT THE CAPILLARY TUBE FLOW PATH WAS CLEAR AND OPEN. LEAK TESTING AT 30 PSI CONFIRMED THAT THE DEVICE LEAKED FROM THE DEVICE CENTER SEPTUM ON THE PERIPHERY AT THE 10 O'CLOCOK POSITION AT A RATE OF 30 BREAKAWAY AIR BUBBLES PER MINUTE. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING VARIANCES RELATED TO THIS EVENT FOR THIS DEVICE. HOWEVER, THE REVIEW OF THE DHR DID REVEAL THAT THIS DEVICE WAS PART OF THE MANUFACTURER'S DECEMBER 13, 1991, DEVICE RECALL DUE TO THE POTENTIAL FOR LEAKAGE FROM THE DEVICE SEPTUM. BASED ON THE INFORMATION AVAILABLE AND THE RESULTS OF THE MANUFACTURER'S ANALYSIS, THE COMPLAINT THAT "THE DEVICE LEAKED FROM THE DEVICE CENTER SEPTUM. BASED ON THE INFORMATION AVAILABLE AND THE RESULTS OF THE MANUFACTURER'S ANALYSIS, THE COMPLAINT THAT "THE DEVICE LEAKED FROM THE DEVICE CENTER SEPTUM" HAS BEEN CONFIRMED. CORRECTIVE ACTION CONCERNING THIS EVENT WAS TAKEN THROUGH THE MANUFACTURER'S DECEMBER 13, 1991 DEVICE RECALL FOR THE POTENTIAL OF LEAKAGE FROM THE DEVICE SEPTUM. NO FURTHERE DETAILS ARE AVAILABLE. THE MANUFACTURER IS NOW CLOSING THE FILE ON THIS EVENT.
ON 10/15/96, A MFR REP WAS PRESENT FOR A ROUTINE POST-OP NUCLEAR PERFUSION STUDY. DURING THE PROVISION STUDY, WHEN THE NURSE ACCESSED THE DEVICE, IT APPEARED AS THOUGH THE FLUID WAS ONLY POOLING AROUND THE DEVICE SIDEPORT. THE PT WAS TAKEN TO INTERVENTIONAL RADIOLOGY WHERE AGAIN IT WAS CONFIRMED THAT THE SOLUTION WAS ONLY POOLING AROUND THE DEVICE SIDEPORT. AT THAT TIME, A MFR NURSE WAS CONTACTED WHO SUGGESTED THAT DYE BE INJECTED THROUGH THE DEVICE SIDEPORT, FOLLOWING ALL CAUTIONS, IN AN EFFORT TO DETECT THE PROBLEM. THE DYE STUDY WAS PERFORMED AND THE DEVICE SIDEPORT FILLED BUT THE DEVICE CATHETER DID NOT. THE INTERVENTIONAL RADIOLOGIST STATED THAT THERE DID NOT SEEM TO BE ANY ARTERIAL PRESSURE. THE MFR FELT THAT THIS EVENT WAS DUE TO AN OCCLUSION OF A VESSEL OR HAPTIC ARTERY THROMBOSIS.
ON 10/16/96, PRIOR TO PERFORMING THE DECLOTTING PROCEDURE WITH A MFR NURSE PRESENT, THE FACILITY NURSE ASPIRATED QUITE A BIT OF FLUID OFF THE TOP OF THE DEVICE. THE PRODUCT ALSO HAD QUITE OF SWELLING. ONCE THE SOLUTION WAS REMOVED FROM THE TOP OF THE DEVICE, IT WAS DISCOVERED THROUGH PALPATION THAT THE DEVICE HAD FLIPPED. THE PT WAS TAKEN TO RADIOLOGY WHERE IT WAS CONFIRMED THAT THE DEVICE HAD FLIPPED OVER. AT THAT TIME, IT WAS DECIDED THAT THE PT WOULD HAVE REVISION SURGERY TO FLIP THE DEVICE BACK OVER AND CHECK THAT THE INTEGRITY OF THE DEVICE HAD NOT BEEN COMPROMISED. FURTHER COMMUNICATION VIA A MANUFACTURER REP, ON 10/22/96, REVEALED THAT ANOTHER NUCLEAR PROVISION PERFUSION STUDY WAS PERFORMED ON 10/21/96 TO CHECK PERFUSION OF THE DEVICE AND TO GUARANTEE DEVICE INTEGRITY. THE PERFUSION STUDY WENT FINE, THE DEVICE WAS REFILLED WITH CHEMO, AND THE DEVICE IS FUNCTIONING AS INTENDED. AS PART OF CO'S INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MANUFACTURING VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. BASED ON THE INFO AVAILABLE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF DEVICE ROTATION. SINCE THE DEVICE REMAINS IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY AND IS FUNCTIONING AS INTENDED, CO WILL BE CLOSING THIS FILE ON THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO INADEQUATE PRESSURE.
ON 10/10/96, THE FACILITY CONTACTED A MFR NURSE AND REPORTED THAT ON THE 29TH DAY OF REFILL CYCLE THE PT COMPLAINED OF PAIN. THE DEVICE WAS IMPLANTED ON 11/19/92 FOR MORPHINE INFUSION FOR TREATMENT OF PAIN. THE DEVICE FLOWRATE DATA IS AS FOLLOWS: 04/1996=1.14; 5/1996=1.14; 6/1996=1.1; 8/1996=1.06; 9/1996=1.06. INITIAL ATTEMPTS TO FIND THE CALIBRATED FLOWRATE FOR THIS DEVICE AND SEND PDS WERE UNSUCCESSFUL WITH THE PT'S INITIALS. THE MFR NURSE SUGGESTED THAT THE FACILITY PERFORM AN AIRLOCK PROCEDURE AND IF NO AIR IS RETURNED, PERFORM A CATHETER PATENCY STUDY. IF AIR IS RETURNED, THIS MAY RE-ESTABLISH FLOWRATE.
FURTHER COMMUNICATION, VIA A MFR REPRESENTATIVE, ON 10/17/96 REVEALED THAT THE EXPECTED FLOWRATE FOR THE DEVICE PRESENTLY IMNPLANTED IS 1.54ML/DAY. IT WAS ADDITIONALLY STATED THAT THE ACTUAL FLOW RATE OF 1.06 TO 1.14 IS CLOSE TO THE CALIBRATED FLOW RATE OF 1.54 AND THAT THE FACILITY DOES NOT FEEL THAT THERE OIS A PROBLEM WITH THE DEVICE. THE FACILITY HAS DECIDED THAT THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY. AS PART OF CO'S INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THIS DEVICE WAS PART OF THE MFR'S 12/13/91 DEVICE RECALL DUE TO THE POTENTIAL FOR DEVICE LEAKAGE FROM THE DEVICE SEPTUM; HOWEVER, THE DEVICE WAS RETURNED AND REWORKED PRIOR TO SHIPMENT AND IMPLANTATION INTO THIS PT. THIS DEVICE IS ALSO PART OF THE MFR'S OCTOBER 1992 DEVICE SAFETY ALERT CONCERNING THE POTENTIAL FOR DEVICE SEPTUM DISLODGEMENT. NO MANUFACTURING VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE FACILITY'S REPORT OF A SLOW FLOWRATE IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE, AND DUE TO UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
AN AUS DEVICE WAS IMPLANTED, DATE NOT INDICATED. ON 6/19/91, A CONNECTOR WAS REVISIED. ON 9/17/96, THE CUFF WAS REMOVED FROM THE PT DUE TO EROSION-CUFF.
THE DEVICE WAS IMPLANTED ON 3/13/96 FOR SUBCLAVIAN INFUSION OF CHEMOTHERAPY. ON 9/23/96, THE PT CONTACTED THE MFR AND REPORTED THAT THE DEVICE CATHETER HAD "CRACKED" AS A RESULT, THE DEVICE WAS EXPLANTED ON 9/20/96. ON 10/08/96, THE MFR CONTACTED THE IMPLANT/EXPLANT PHYSICIAN TO OBTAIN ADD'L DETAILS CONCERNING THIS EVENT. THE PHYSICIAN'S MEDICAL ASSISTANT REPORTED THAT THE DEVICE WAS IMPLANTED AND "WORKED WELL" FOR FIVE MONTHS; HOWEVER, AFTER FIVE MONTHS A LEAK WAS NOTED COMING OUT OF THE DEVICE.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED WITH THE FOLLOWING RESULTS: CORING WAS SEEN ON THE DEVICE SEPTUM IN TWO PIECES. INTERNAL FRACTURE PLANE DAMAGE WAS NOT FOUND. INITIAL VISUAL EXAMINATION REVEALED TWO "LONGITUDINAL SLITS" PARALLEL TO ONE ANOTHER ON THE DEVICE CATHETER APPROXIMATELY THREE INCHES FROM THE DISTAL END. EVIDENCE OF COMPRESSION WITH YELLOW DISCOLORATION WAS SEEN. THE UNIT WAS PATENT UPON FLUSHING. PRESSURE AND LEAK TESTING CONFIRMED THAT THE DEVICE DID NOT LEAK, EXCEPT AT THE DAMAGED AREA OF DEVICE CATHETER. NO OTHER ANOMALIES OR DEFECTS WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CATALOG/LOT NUMBER AND NO MANUFACTURING VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORT INVOLVING THIS CATALOG/LOT NUMBER AND NO TRENDS WERE IDENTIFIED. THE PT'S REPORT THAT THE DEVICE CATHETER HAD "CRACKED" WAS CONFIRMED BY THE RESULTS OF THE MFR ANALYSIS. THIS EVENT APPEARS TO BE ATTRIBUTABLE TO "PINCH-OFF" SYNDROME. THE PHYSICIAN WILL BE ISSUED AN ARTICLE EXCLUSIVE TO "PINCH-OFF" SYNDROME DIAGNOSIS FOR HIS REVIEW IN AN ATTEMPT TO PREVENT RECURRENCE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCINTINENCE.
THE PUMP WAS REPOSITIONED DUE TO DIFFICULT ACTIVATION.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. ADD'L LOT/SER #: 1341P 005.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER WAS FUNCITONAL. CYLINDER HAD A WEAR LEAK.
THE DEVICE WAS REMOVED FROM THE PT DUE TO SEMI ERECT PENIS SECONDARY TO FAILED PENILE PROSTHESIS. ADDITIONALLY, PROSTHESIS WITH INABILITY TO REMAIN FULL AFTER THE CYLINDERS WERE FILLED CONSISTENT WITH MECHANICAL FAILURE. ADD'L LOT/SER #: AC521 005.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-RESERVOIR. ADD'L LOT/SER #: A0116 009.
PUMP PERFORMED WITHIN SPECS. RESERVOIR HAD A WEAR LEAK. CYLINDER PERFORMED WITHIN SPECS.
INFORMATION RECEIVED ON 11/11/96 INDICATES REASON AS WOULD NOT INFLATE. HOSPITAL REFUSED TO DISCLOSE PATIENT NAME, IMPLANTING PHYSICIAN, AND SERIAL NUMBERS.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD OR DAMAGE. CYLINDERS HAD OR DAMAGE. TUBING HAD OR DAMAGE.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO PUMP-WOULD NOT PUMP UP THE DEVICE.
PUMP PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION, UNHAPPY WITH RESULTS. ADD'L LOT/SER NO: BV008 009.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER HAD OR DAMAGE. CYLINDER PERFORMED WITHIN SPECS. TUBING HAD OR DAMAGE.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO PAIN AND PT DISSATISFACTION. ADD'L LOT/SER NO: CD995 017.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER PERFORMED WITHIN SPECS. TUBING HAD OR DAMAGE.
ENTIRE DEVICE WAS REMOVED FROM PT DUE TO EROSION AND INFECTION. ADD'L LOT/SER NO: BQ949 003.
A QUESTIONAIRE WAS RETURNED INDICATING THAT IF THIS FOLDING PROBLEM WERE TO RECUR, IT COULD CAUSE SERIOUS INJURY.
NO ADD'L INFO HAS BEEN RECEIVED DESPITE REQUEST TO REPORTER. THE COMPLAINT OF FOLDING PROBLEMS WAS NOT VERIFIED DURING EVAL OF THE RETURNED LENS. THE LENS WAS FOLDABLE. IT WAS NOTED THAT ONE HAPTIC OF THE LENS WAS BROKEN. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED=1.
PT WAS ADMITTED ON 8/25/96 WITH A SUBARACHNOID HEMORRHAGE SECONDARY TO A RUPTURED ANEURYSM. ANGIOGRAM ALSO SHOWED AN UNRUPTURED RIGHT MIDDLE COMMUNICATING ARTERY ANEURYSM. PT UNDERWENT A CRANIOTOMY AND CLIPPING OF BOTH ANEURYSMS. ON 8/26/96 VENTRICULOSTOMY WAS PERFORMED. ON 8/27/96, AN EMERGENCY CRANIOTOMY WAS DONE WITH DECOMPRESSION AND RIGHT TEMPORAL LOBECTOMY. ON 9/1/96, CEREBRAL SPINAL FLUID CULTURE WAS POSITIVE FOR NUMEROUS STAPHYLOCOCCUS AUREUS AND MODERATE STAPHYLOCOCCUS EPIDERMIS. PT'S MENINGITIS WAS TREATED WITH CEFTIZOXIME, NAFCILLIN AND RIFAMPIN. ON 9/2/96 LEAKAGE WAS NOTED AT THE VENTRICULOSTOMY CATHETER SITE. ON 9/7/96, A TRACHEOSTOMY AND J-TUBE WERE PLACD. ON 9/8/96, VENTRICULOSTOMY WAS REMOVED. ON 9/11/96, THE CEREBROSPINAL FLUID CULTURE SHOWED NO GROWTH X4 DAYS.
THE IAB WAS INSERTED INTO THE PATIENT ON 9/19/96. ON 9/20/96 AFTER IABP FOR 23 HOURS THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER AND THE IAB WAS REMOVED BY A CARDIAC SURGEON. EVENT COMPLICATIONS: UNK - REPORTED 9/27/96; NONE - REPORTED 10/18/96. PATIENT'S CURRENT STATUS: IN STEPDOWN - RPT'D 10/18.
CUT AND COAG MODES ACTIVATE AUTOMATICALLY AND WOULD ONLY CEASE ACTIVATING WHEN ESU WAS TURNED "OFF".
ON 9/30/96, THE DEVICE WAS TESTED. THE DEVICE WAS FOUND TO PERFORM AS INTENDED. THERE WAS NO EVIDENCE OF PRODUCT DEFECT.
THE NL 950-V CATHETER WITH ID TAG 0684, WAS RECEIVED WITHOUT THE KIT PARTS. VISUAL EXAM REVEALED THE CATHETER WAS GROSSLY CONTAMINATED WITH WHAT APPEARED TO BE COAGULATED BLOOD. APPROX 2 CM OF THE TENSILE MEMBER AT THE DISTAL END WAS TORN FREE WITHIN THE DRAINAGE LUMEN. A DIAGONAL CUT THROUGH THE DRAINAGE LUMEN AT 12 CM FROM THE DISTAL END WAS DISCOVERED. THE CUT EXTENDED HALF WAY INTO THE CATHETER DIAMETER AND STOPPED AT THE TENSILE MEMBER. SUTURES STILL REMAINED ON THE CATHETER AT APPROX 13 AND 14 CM FROM THE DISTAL END. THE CATHETER WAS CONNECTED TO THE ICP MONITOR AND FOUND TO BE FUNCTIONING. THE DRAINAGE LUMEN OF THE CATHETER WAS CUT AT APPROX 12 CM FROM THE DISTAL END. CO'S MFG PROCESS FOR THE NL 950-V INCLUDES 100% LEAK TEST OF THE CATHETER BODY PRIOR TO MFG. ALSO, 100% VISUAL INSPECTION IS PERFORMED ON THE COMPLETED ASSEMBLY PRIOR TO PACKAGING. CONSEQUENTLY, THE MOST  LIKELY CAUSE OF THE CUT TO THE CATHETER AND SUBSEQUENT LEAKAGE WOULD APPEAR TO BE A CUT INTO THE DRAINAGE LUMEN DURING EITHER PLACEMENT OR SUTURING OF THE CATHETER.
PATIENT ADMITTED ON 8-25-96 WITH A SUB-ARACHNOID HEMORRHAGE SECONDARY TO A RUPTURED ANEURYSM. ANGIOGRAM ALSO SHOWED AN UNRUPTURED RIGHT MIDDLE COMMUNICATING ARTERY ANEURYSM. PATIENT UNDERWENT A CRANIOTOMY AND CLIPPING OF BOTH ANEURYSMS. ON 8-26-96 VENTRICULOSTOMY WAS PERFORMED. ON 8-27-96, AN EMERGENCY CRANIOTOMY WAS DONE WITH DECOMPRESSION AND RIGHT TEMPORAL LOBECTOMY. ON 9-1-96, CEREBRAL SPINAL FLUID CULTURE WAS POSITIVE FOR NUMEROUS STAPHYLOCOCCUS AUREUS AND MODERATE STAPHYLOCOCCUS EPIDERMIS. PATIENT'S MENINGITIS WAS TREATED WITH CEFTIZOXIME, NAFCILLIN AND RIFAMPIN. ON 9-2-96 LEAKAGE WAS NOTED AT THE VENTRICULOSTOMY CATHETER SITE. ON 9-7-96, A TRACHEOSTOMY AND J-TUBE WERE PLACED. ON 9-8-96, VENTRICULOSTOMY WAS REMOVED. ON 9-11-96, THE CEREBROSPINAL FLUID CULTURE SHOWED NO GROWTH X4 DAYS.
UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECTED TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY.
THE IAB WAS INSERTED INTO THE PATIENT ON 8/1/96. ON 9/24/96 AFTER IAB FOR 55 DAYS, THE "HIGH LEAK" ALARM SOUNDED FROM THE PUMP AND DRY BLOOD WAS NOTED IN THE TUBING. THE PUMP WAS PUT ON STANDBY AND THE PATIENT WAS TAKEN TO SURGERY WHERE A SECOND IAB WAS INSERTED. DATASCOPE WAS INFORMED THERE WERE NO COMPLICATIONS FROM THE EVENT. THE PATIENT RECEIVED A HEART TRANSPLANT ON 9/25/96 AND IS DOING WELL WITHOUT ANY PROBLEMS.
IT WAS REPORTED THAT ON 2 SEPARATE OCCASIONS THE ACCUSLIDE ALLOWED FLOW WHEN IN THE CLOSED POSITION. THE SETS WERE NOT CONNECTED TO PTS.
TWO SETS WERE RECEIVED AND EVALUATED. ONE SAMPLE WAS VISUALLY EXAMINED AND FOUND TO BE MISSING THE SILVER BALL INSIDE THE ACCUSLIDE WHICH PREVENTS FLOW WHEN THE ACCUSLIDE IS IN THE CLOSED POSITION OR THE SET IS REMOVED FROM PUMP. THE 2ND SET WAS VISUALLY AND FUNCTIONALLY TESTED AND THE REPORT COULD NOT BE DUPLICATED. THE ACCUSLIDE DID HAVE THE SILVER BALL PROPERLY ASSEMBLED INSIDE AND DID NOT ALLOW FLOW WHEN IN THE CLOSED POSITION. CHANGES TO THE MFG PROCESS HAVE BEEN MADE TO PREVENT ASSEMBLING THE ACCUSLIDE WITHOUT THE BALL. ALL OF THIS REPORT WAS FILLED OUT BY THE MFR. THERE IS NO PT INFO BECAUSE THE SETS WERE NOT USED ON PT'S MFR'S REPORT DATE 10/23/96.
IN THE COURSE OF A LAPAROSCOPY PROCEDURE, THE ELECTROSURGICAL CABLE CONNECTED TO A FORCEP SPARKED. THIS OCCURRED AT THE SECTION OF THE CABLE NEAREST THE FORCEPS. THERE WERE NO INJURIES TO THE PHYSICIAN OR THE PT.
DATA STATED IN SECTION F WAS FILLED IN BY THIS MFR. USER FACILITY ORIGINALLY STATED THAT DEVICE WOULD BE RETURNED TO THIS MFR FOR EVAL. TO DATE, SEVERAL RECONTACTS HAVE BEEN MADE WITH THE USER FACILITY, BUT IT IS NOT KNOWN IF THE DEVICE IS AVAILABLE OR NOT AT THIS TIME.
EVENT COMPLICATIONS: NONE FROM THE EVENT - RPT'D 9/27/96. PT CURRENT STATUS: UNK - RPT'D 9/27/96.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE JAW SECTION OF A GRASPING FORCEPS BROKE AND IT BECAME INOPERABLE. ANOTHER GRASPER WAS USED TO COMPLETE THE CASE. NO PT INJURY OCCURRED.
DATA SHOWN IN SECTION F WAS FILLED IN BY THIS MFR. THE METAL BRACKET WALL OF THE JAW MECHANISM IS FRACTURED, ALLOWING PIN TO SLIP OUT OF THE CONNECTION. THIS SECTION WAS ALSO FOUND TO BE BENT. THE CAUSE OF THE BREAKAGE IS ATTRIBUTED TO EXCESSIVE PRESSURE EXERTED ON THE JAWS BY THE USER.
A PT WAS ADMITTED TO THE EMERGENCY ROOM ON 9/2/96. THE PT WAS PUT ON TPA ON PUMP WHILE STILL IN THE EMERGENCY ROOM. THE PT WAS THEN TRANSPORTED TO MICU. WHEN THE PT ARRIVED AT MICU, THE TPA WAS GONE AND THE PT WAS IN CARDOGENIC SHOCK AND WAS BLEEDING. THE PT WAS TRANSFERED TO HOSP WHERE THE PT EXPIRED. THE INFUSION PUMP WAS EVALUATED BY THE BIO TECH DEPT AND WAS FOUND TO HAVE BEEN DROPPED OR BANGED, BENDING A HINGE. THE DOOR WAS FOUND NOT TO CLOSE CORRECTLY AND WOULD WORK ITS WAY OPEN AFTER BEING CLOSED. THE FREE FLOW PINCHER DIDN'T STOP FLOW WHEN THE DOOR WAS OPENED. AN INFUSION COULD NOT BE STARTED WITH THE INFUSION PUMP IN THIS DAMAGED CONDITION. THE INCIDENT WAS EVALUATED BY DR AND FOUND THAT THE INFUSION PUMP DID NOT CAUSE OR CONTRIBUTE IN ANY WAY TO THE DEATH.
PUMP, SERIAL NUMBER 61815, WAS EVALUATED. DUE TO OPERATIONAL DAMAGE THE INFUSION PUMP'S FRONT PANEL WAS BENT OUT OF SPECIFICATION. OTHER DAMAGE INCLUDED A BENT CASE, CRACKED TOP DOOR HINGE AND PUMP BODY BEARING POPPED UP. FLUID RESIDUE WAS FOUND INSIDE CASE, DOOR CAVITY AND UNDER THE MEMBRANE KEYPAD. AUDIO ALARMS WERE NOT WORKING DUE TO IMPROPER CUSTOMER MAINTENANCE OF AUDIO WIRES. VISUAL ALARMS WERE WORKING AS DESIGNED. THE DOOR LATCH CONSTANTLY POPPED OPEN DUE TO IMPROPER INSTALLATION OF THE LATCH. WHEN THE DOOR OPENED, THE INFUSION PUMP FREE FLOWED BECAUSE OF A BENT FLOW STOP LEVER. THE LEVER RUBBED ON THE FRONT PANEL, NOT ALLOWING IT TO FULLY PINCH OFF THE TUBING. THE FLOW STOP LEVER WAS PROBABLY DAMAGED AT THE TIME THE  INFUSION PUMP FRONT PANEL AND CASE WERE DAMAGED.
PHYSICIAN REPORTED THAT PT COMPLAINED OF SEVERE SUDDEN PAIN AND WITHDRAWAL (DRUG USED-MORPHINE). PHYSICIAN CHECKED PUMP UNDER FLUOROSCOPE AND DETERMINED ROTOR WAS NOT RUNNING.
THE METAL PLUG COMPONENT OF THE ACETABULUM PROSTHESIS DID NOT FIT TIGHTLY. THE SURGERY WAS NOT DELAYED, NOR WAS ANY INJURY TO THE PT REPORTED. NO OTHER INFO WAS PROVIDED TO CO.
THE INFORMATION CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES.
THE ONE WAY VALVE DID NOT HOLD A VACUUM ON THE BALLOON.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVAL. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. THIS FORM WAS COMPLETED BY THE MFR.
PT UNDERWENT CATARACT SURGERY ON 10/8/96, AND IMPLANTATION OF A MODEL AQ-2003V INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON STATED THAT THE LENS EJECTED IN AN UNCONTROLLED MANNER AND TORE THE POSTERIOR CAPSULE. AN ANTERIOR VITRECTOMY WAS NECESSARY. NO OTHER SURGICAL PROCEDURES WERE PERFORMED. NO COMPLICATIONS NOTED.
H6-RESULTS: NO DEFECTS WERE PRESENT ON THE DEVICE. THE PT'S VISUAL ACUITY AT ONE WEEK POSTOP WAS 20/25 CORRECTED (IMPROVED FROM PREOP VA WHICH WAS 20/70 CORRECTED). THE INTRAOCULAR PRESSURE WAS 12MM HG. THE IMPLANT IS CLEAR AND CENTERED. THE CAPSULE IS CLEAR. THE PT'S PROGNOSIS IS GOOD. THE ABOVE REFERENCED LENS BOX WAS RECEIVED. THE BOX CONTAINED 9 CHART LABELS, THE PT ID CARD, PT REGISTRATION CARD, AND LENS TRAY. THE LENS TRAY CONTAINED THE BASE AND TOP INSERTS, WITH THE LENS LOCATED IN BETWEEN THE INSERTS. TAPE WAS HOLDING THE LENS AND INSERTS WITHIN THE TRAY. THE LENS WAS REMOVED FROM BETWEEN THE INSERTS AND INSPECTED FOR DEFECTS THAT MAY HAVE CAUSED THE LENS TO EJECT IN AN UNCONTROLLED MANNER AND A POSTERIOR CAPSULE TEAR. THE LENS HAS DRIED BLOOD AND BSS/VISCOELASTIC RESIDUE PRESENT. THE LENS WAS INSPECTED ACCORDING TO COSMETIC SPECIFICATIONS. NO DEFECTS ARE PRESENT THAT WOULD INDICATE THIS LENS EJECTED IN AN UNCONTROLLED MANNER.
THE LIGHT FELL AFTER THE COMPLETION OF THE PROCEDURE.
THERE WAS NO INJURY SO PT CODES ARE NOT APPLICABLE.
MD APPLIED FIXATOR TO TREAT A FRACTURE OF THE DISTAL RADIUS. APPROX. TWO WEEKS AFTER APPLICATION, PT RETURNED TO MD'S OFFICE WITH THE PROXIMAL CLAMP COVER LOOSE WHICH RESULTED IN A LOSS OF FRACTURE REDUCTION. THE FIXATOR WAS REPLACED.
THE MD APPLIED THE FIXATOR TO TREAT A DISTAL RADIUS FRACUTRE. THE PT SUBSEQUENTLY RETURNED TO THE MD'S OFFICE BECAUSE THE BALL JOINT HAD LOOSENED. THE MD WAS ABLE TO RETIGHTEN THE BALL JOINT IN HIS OFFICE. THERE WAS NO INJURY TO THE PT.
DEVICE LABEL CODES: 1738, 1738. UNDERWATER LEAK TESTING DISCLOSED MULTIPLE LEAKS IN THE IAB MEMBRANE. UNDER MICROSCOPY, A SMOOTH-EDGED PENETRATION WAS SEEN AT EACH LEAK SITE. PROBABLE CAUSE OF DIFFICULTY: THE PHYSICAL EVIDENCE INDICATES THAT THE SOURCE OF THE BALLOON LEAKS WERE PENETRATIONS OF THE MEMBRANE PROBABLY CAUSED BY CONTACT WITH A SHARP EDGED OBJECT. THE MEMBRANE DAMAGE MAY HAVE OCCURRED PRIOR TO OR DURING BALLOON INSERTION.
WHEN INSERTING THE CATHETER, THE DR. NOTICIED A "HOLE" IN THE DISTAL END OF THE BALLOON CATHETER. HE REMOVED THE "BAD" CATHETER AND INSERTED A GOOD ONE. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 9/26/96 AND 10/18/96. PATIENT'S CURRENT STATUS: GOOD - RPT'D 10/18/96.
THE LOCKING MECHANISM THAT SECURES THE BONE SCREW TO THE SPINE INSTRUMENTATION CONSTRUCT WOULD NOT ENGAGE. A SECOND LOCKING MECHANISM WAS NECESSITATED. NO INJURY TO THE PT WAS REPORTED. NO OTHER INFO WAS PROVIDED TO CO.
PHYSICIAN REPORTED THAT PUMP "MALFUNCTION" MAY HAVE BEEN CAUSED BY THE PUMP RECEIVING "TOO MUCH RADIATION". PUMP EXPLANTED AND NO REPLACEMENT REGISTERED TO DATE.
4/13/1998: MANUFACTURER REPORT NUMBER HAS BEEN CORRECTED HERE AND IN HEADER.  MANUFACTURER ADDRESS LISTED.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 9/26/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 9/26/96.
THE CATHETER WAS BEING ADVANCED CONTRALATERALLY WHEN THE TIP SEPARATED. THE SEPARATED SEGMENT WENT DOWN TO THE PROFUNDA WHERE IT WAS SNARED AND WITHDRAWN TO THE SHEATH. HOWEVER, THE PHYSICIAN WAS UNABLE TO REMOVE THE SEGMENT AS IT SEPARATED AGAIN. AN ARTERIOGRAM CUTDOWN WAS PERFORMED TO RETRIEVE THE TIP.
A. 1) INFO WAS NOT AVAILABLE, D. 6) LOT#-INFO WAS NOT AVAILABLE, 5) WITHOUT LOT# INFO, UNABLE TO DETERMINE. F. 9) WITHOUT LOT# INFO, UNABLE TO DETERMINE. H. 4) WITHOUT LOT# INFO, UNABLE TO DETERMINE. 6) METHOD-DEVICE NOT RETURNED FOR EVALUATION. NO PRODUCT WAS RETURNED FOR EVAL. CO CAN ADVISE THAT ON 9/24/96, A VOLUNTARY RECALL OF THIS PRODUCT LINE WAS INITIATED. THE APPROPRIATE PERSONNEL ARE CURRENTLY INVESTIGATING THIS MATTER.
DEVICE LABEL CODES: 1738. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY UNFOLDED. BLOOD WAS NOTED ON THE EXTERIOR OF THE IAB AND WITHIN THE INNER LUMEN. THE SHEATH USED WITH THE IAB WAS ALSO RETURNED. SHEATH WAS NOT IN PLACE OVER THE CATHETER TUBING. THE SHEATH WAS NOTED TO BE KINKED AT THE SHEATH/SHEATH HUB JUNCTION. THE SHEATH AND CATHETER WERE MEASURED AND FOUND TO BE WITHIN CO'S MFG SPECIFICATIONS. THE UNFOLDED MEMBRANE APPEARED NORMAL UNDER ROOM LIGHT AND POLARIZED LIGHT. IT WAS NOT POSSIBLE TO PASS THE UNFOLDED MEMBRANE THROUGH A LABORATORY 6" SHEATH DUE TO THE CONDITION OF THE RETURNED MEMBRANE BUT IS WAS POSSIBLE TO PASS A LABORATORY FOLDED MEMBRANE THROUGH THE RETURNED SHEATH/HEMOSTASIS SHEATH ASSEMBLY. PROBABLE CAUSE OF DIFFICULTY: EVEN THOUGH NO MFG DEFECTS WERE FOUND IN THE UNFOLDED MEMBRANE OR IN THE RETURN SHEATH BASED ON THE EXAMINATION, IT WAS NOT POSSIBLE TO VERIFY THE ENCOUNTERED DIFFICULTY DUE TO THE CONDITION OF THE RETURNED ITEM. IN GENERAL, DIFFICULTY ADVANCING THE IAB INTO THE SHEATH MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: THE USER MAY HABE NOT DRAWN A SUFFICIENT VACUUM ON THE BALLOON DURING ITS REMOVAL FROM THE BLISTER TRAY. IF DRAWN, A VACUUM MAY HAVE NOT BEEN MAINTAINED THROUGHOUT THE INSERTION PROCEDURE. DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK (THIS IS SUPPORTED BY THE CONDITION OF THE RETURNED SHEATH). THE PATIENT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO THE SHEATH (AS EVIDENCED BY THE CONDITION OF THE RETURNED SHEATH AND BALLOON'S INNER LUMEN AT THE PROXIMAL TAPER). DURING IAB INSERTION, THE BALLOON TIP MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY AS IT EXITED THE END OF THE SHEATH.
EVENT COMPLICATIONS: UNK - REPORTED 9/25/96; NONE - REPORTED 10/31/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 9/25, 10/31/96.
DONOR EXPERIENCED RED URINE FOLLOWING PLASMA DONATION. BRIEF PERIOD OF FAINTNESS BUT NO FURTHER ADVERSE REACTIONS REPORTED.
DURING A PLASMA PROCEDURE THE DEVICE RETURN HAD A VALVE CLOSED WHICH CAUSED BLOOD PUMP TO TURN AGAINST CLOSED TUBING RESULTING IN RED CELL HEMOLYSIS IN THAT PORTION OF THE TUBING. THE OPERATOR PUSHED RETURN WHICH ALLOWED THOSE HEMOLYZED RED CELLS TO RETURN TO DONOR WHO EXPERIENCED BRIEF FAINTNESS AND SOME RED URINE. THE DONOR EXPERIENCED NO FURTHER REACTIONS AND WAS TREATED WITH IV FLUID VOLUME AT HOSP. THE VALVE THAT REMAINED CLOSED DURING RETURN  WAS EVALUATED BY MFR AND NO FAILURES OR FAULTS WERE FOUND. NO CAUSE FOR THIS EVENT WAS DETERMINED.
AS THE WIRE GUIDE AND CATHETER WERE BEING ADVANCED UP TO CAROTID, THE PHYSICIAN NOTED THE TIP OF CATHETER MOVING WITH THE WIRE GUIDE. THE TIP WAS DETERMINED TO HAVE SEPARATED FROM THE CATHETER. THE WIRE WAS RETRACTED AND THE TIP PULLED BACK DOWN TO THE AORTA. THE SEPARATED SEGMENT WAS SUBSEQUENTLY RETRIEVED.
A. 1) INFO WAS NOT AVAILABLE. H. 6) METHOD-DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT WAS RETURNED FOR EVAL. HOWEVER, CO CAN ADVISE IT HAS SEEN TIP SEPARATION ON THIS PRODUCT IN THE PAST. ON 9/24/96, CO INITIATED A VOLUNTARY PRODUCT RECALL OF THE PRODUCT LINE. THE APPROPIATE PERSONNEL ARE CURRENTLY INVESTIGATING THIS MATTER.
PHYSICIAN REPORTED THAT THE PUMP WAS NOT INFUSING AND WAS REPLACED. PT RECOVERING WITH NO RESIDUAL EFFECTS. VERY LIMITED INFO IS AVAILABLE FROM FOREIGN SOURCE. A-3 SEX OF PT IS UNKNOWN. H-3 DEVICE IS PRESENTLY UNDERGOING ANALYSIS.
DURING A CAROTID STUDY, AS THE PHYSICIAN PULLED THE CATHETER BACK INTO THE AORTIC ARCH, THE TIP SEPARATED. THE TIP WAS RETRIEVED FROM THE RENAL ARTERY. THE PT HAS NOT SUSTAINED ANY ADVERSE EFFECT FROM THIS EVENT.
NO PRODUCT WAS RETURNED FOR EVALUATION. HOWEVER, CO CAN ADVISE IT HAS SEEN THIS TYPE OF DAMAGE OCCUR IN THE PAST. THEREFORE, A VOLUNTARY RECALL OF THIS PRODUCT LINE HAS BEEN INITIATED. THE APPROPRIATE PERSONNEL ARE CURRENTLY INVESTIGATING THIS MATTER.
INCIDENTS REPORTED IN WHICH AFTER TWO DAYS IN USE, THE CUFF BEGINS TO LEAK AIR. PTS VOLUMES BEGIN TO BECOME ERRATIC, AND UPON EXAM, THE CUFF IS LEAKING. DOES NOT OCCUR IN THE OPERATING ROOM. THIS IS DUE TO THE PT'S HAVING THE ET TUBE IN SHORT TERM. EXTUBATION AND RE-INTUBATION OF PT REQUIRED. NO PT COMPROMISE. THIS IS OCCURRING MORE FREQUENTLY. 7 1/2 AND 8 TUBES UTILIZED.
EVALUATION RESULTS: ONE USED I.D.: 7.0MM, STANDARD LOW PRESSURE CUFF WAS RECEIVED. PRODUCT WAS RECEIVED WITHOUT THE PILOT BALLOON. THE RETURNED PRODUCT WAS DECONTAMINATED AND EXAMINED. THE MACHINE END OF THE TUBE WAS FOUND TO BE MISSING FROM 23RD TO 28TH GRADUATION MARKS WITH IRREGULAR EDGES INDICATING THE AFFECTED AREA HAD BEEN CUT OFF AND CONNECTOR REASSEMBLED. A FRESH FUNCTIONAL PILOT BALLOON WITH VALVE WAS TAKEN FROM PRODUCTION AND REASSEMBLED TO THE PILOT TUBE. PRODUCT WAS SUBJECTED TO A LEAK TEST AND NO LEAK WAS OBSERVED. SINCE THE PILOT BALLOON WAS NOT RETURNED, FURTHER INVESTIGATION COULD NOT BE CARRIED OUT.
DEVICE LABEL CODES: 1701, 1738. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
THE IAB WAS INSERTED INTO THE PATIENT ON 9/23/96. ON 9/24/96 AFTER IAB FOR 24 HOURS, THE "RAPID GAS LOSS" ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED INTO THE PATIENT. MULTIPLE EVENT TO INITIAL COMPLAINT NUMBER 96-00156. EVENT COMPLICATIONS: UNK - REPORTED 9/26/96 AND 10/18/96. PATIENT'S CURRENT STATUS: STABLE RPT'D 10/18/96.
THE DEVICE WAS BEING UTILIZED ON A PT FOLLOWING A LIVER TRANSPLANT. UPON REMOVAL OF THE DEVICE AIR WAS INTRODUCED THROUGH THE CONNECTING TUBE VIA THE INTRODUCER INTO THE PT'S PULMONARY ARTERY. THIS EVENT LED TO MONITORING PROBLEMS WITH THE PT OVERNIGHT. THE PT DID EVENTUALLY STABILIZE AND HAS NOT SISTAINED ANY ADVERSE EFFECT AS A RESULT.
A. 1,2,3,4) INFO WAS NOT AVAILABLE. H. 6) CONCLUSIONS-SEE ATTACHED EVAL SUMMARY. D. 6)LOT#-NO LOT NUMBER INFO AVAILABLE. H. 4)WITHOUT LOT# INFO, UNABLET TO OBTAIN MFG DATE. D. 5) WITHOUT LOT# INFO, UNABLE TO DETERMINE EXPIRATION DATE. NO PRODUCT WAS RETURNED FOR EVAL. BASED ON THE AVAILABLE INFO, CO WAS ABLE TO DUPLICATE THE DIFFICULTY DURING IN VITRO TESTING. CO CAN ADVISE CO HAS INITIATED A CHANGE REQUEST, #96-2110, WHICH ELIMINATE THE POSSIBILTY OF THIS RECURRING.
WHEN PT WAS FOUND BY HOSP STAFF SHE WAS UNCONSCIOUS. "CODE BLUE" WAS IMPLEMENTED. SHE WAS PLACED ON A VENTILATOR AND SHOWED LOW BRAIN ACTIVITY. ON 10/1/96 THERE WAS STILL NO BRAIN ACTIVITY, THE VENTILATOR WAS REMOVED AND THE PT WAS PRONOUNCED DEAD AT 10:27 AM.
WHILE THIS DEVICE WAS BEING USED TO EXPAND ANOTHER MFR'S CORONARY STENT IN A HIGHLY STENOTIC CALCIFIED LESION, THE BALLOON OF THIS DEVICE BURST.
ALL MEASUREMENTS TAKEN MEET SPECIFICATIONS. REVIEW OF DHR REVEALED NO RELATED COMMENTARY.
PUMP WOULD NOT FUNCTION. ROTOR WOULD NOT TURN. PRIOR TO REMOVAL A NURSE FROM THE CO. CHECKED THE INFUSION PUMP OUT.
4/13/1998: G9 - MFR REPORT NUMBER HAS BEEN CORRECTED HERE AND IN HEADER ON PAGE 1.
A 3.4X8MM IMPLANT WAS PLACED ON 5/9/96. MOBILITY WAS NOTED AT TIME OF EXPOSURE ON 7/31/96. IMPLANT DID NOT INTEGRATE AND WAS REMOVED 9/12/96. ONE PERSON AFFECTED.
THE IMPLANT WAS SENT BY THE DOCTOR TO ONE OF THE COMPANY REPRESENTATIVES, WHO UNFORTUNATELY LOST IT. A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. TECHNIQUE MAY HAVE BEEN A FACTOR IN THIS CASE. THE DOCTOR INDICATED THAT AN X-RAY REVEALED PENETRATION OF THE IMPLANT THROUGH SOFT TISSUE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
PT WAS POST-OP TRACHEOTOMY, WHO WAS TRANSPORTED TO RECOVERY ROOM ON A VENT. WITHIN 30 MINUTES, PT STARTED LOSING HEART RATE AND BLOOD PRESSURE PERMETER - EMERGENCY MEDICATIONS WERE GIVEN, BUT PT LOST PULSE. PT WAS TAKEN OFF VENTILATOR AND AMBU BAGGED BY HAND. VENT WOULD NOT CYCLE. PT RECOVERED, WAS PLACED ON ANOTHER VENTILATOR, AND BECAME STABLE.
THE BALLOON OF THIS DEVICE BURST WHILE DILATING A HIGHLY STENOTIC CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY.
ALL MEASUREMENTS TAKEN MEET SPECIFICATIONS.
HOSP CCU PERSONNEL RESPONDED TO A PT DESCRIBED AS IN CARDIAC ARREST. THE DEVICE WOULD NOT DELIVER ENERGY TO THE PT IN TWO CONSECUTIVE ATTEMPTS. POWER TO THE DEVICE WAS CYCLED AND THE DEVICE SUBSEQUENTLY OPERATED PROPERLY. THE PT WAS RESUSCITATED.
IN AN EVAL OF THE DEVICE, CO OBSERVED AN INTERMITTENT FAILURE OF THE DEVICE TO DELIVER ENERGY WHEN THE PADDLE DISCHARGE SWITCHES WERE PRESSED. FURTHER EVAL OBSERVED THE STERNUM PADDLE DISCHARGE SWITCHCOVER WOULD BIND WHEN PRESSED ON THE EDGE OF THE SWITCH, NOT ACTIVATING THE SWITCH. THE PADDLES ASSEMBLY WAS REPLACED AND DEVICE RETURNED TO THE CUSTOMER FOR USE.
THE BALLOON OF THIS DEVICE BURST WHILE DILATING A HIGHLY STENOTIC CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY.
THE DEVICE FELL OUT OF THE INNER BLISTER AS THE PRODUCT WAS BEING OPENED. THE DEVICE WAS RESTERILIZED AND IMPLANTED INTO THE PT WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: VISUAL INSPECTION OF THE RETURNED INNER PACKAGE REVEALED A COMPLETE AND UNIFORM ADHESIVE TRANSFER ON ALL SURFACES INTENDED FOR SEALING, INDICATING THAT A SEAL WAS ORIGINALLY PRESENT ON THE POUCH.
EMERGENCY ROOM PERSONNEL WERE ATTENDING TO A PT IN FULL CARDIAC ARREST, REPORTED TO BE DOWN FOR TWENTY MINUTES PRIOR TO EMS ARRIVAL. AN ATTEMPT WAS MADE TO EXTERNALLY PACE THE PT, HOWEVER ALLEGEDLY THERE WAS NO OUTPUT FROM THE PACER. THE BASIS FOR THIS OPINION OF A MALFUNCTION WAS THE LACK OF EXPECTED MUSCULAR REACTION TO PACING CURRENT. A BACK UP UNIT WAS OBTAINED AND USED WITH THE SAME RESULT. THE PT WAS NOT RESUSCITATED. THE REPORTER STATED THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THIS OPINION WAS BASED ON THE REPORTER'S ASSESSMENT OF THE PT'S VIABILITY AND THE AVAILABILITY OF A BACK UP UNIT.
THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. EXCEPT AS PROVIDED BY 21 CFR PART 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA. SECTION A. ALL PT RELATED INFO MADE AVAILABLE BY REPORTER HAS BEEN INCLUDED IN THIS REPORT. F10. CODE #2199-LABELING NA.
WHILE THIS DEVICE WAS BEING USED TO EXPAND ANOTHER MFR'S CORONARY STENT IN A HIGHLY STENOTIC, CALCIFIED LESION, THE BALLOON OF THIS DEVICE BURST.
PT WAS POST-OP TRACHEOSTOMY, WHO WAS TRANSPORTED TO THE RECOVERY ROOM ON A VENTILATOR. WITHIN 30 MINUTES, PT STARTED LOSING HEART RATE AND BLOOD PRESSURE PARAMETERS. EMERGENCY MEDICATIONS WERE GIVEN, BUT PT LOST PULSE. THE PT WAS TAKEN OFF THE VENTILATOR AND AMBU BAGGED BY HAND, THE VENTILATOR WOULD NOT CYCLE. THE PT RECOVERED AND WAS PLACED ON ANOTHER VENTILATOR AND BECAME STABLE.
THE RESPIRATORY THERAPY DEPT AN THE BIOMEDICAL DEPT DID NOT HAVE ANY RECORDS OF THIS VENTILATOR FAILURE, NOR WAS THERE ANY INVESTIGATION PERFORMED ON THIS VENTILATOR. THE RESPIRATORY DEPT SUGGESTED THAT THE EVENT MAY HAVE BEEN OPERATOR ERROR, CORRECTED AT THE TIME OF THE EVENT. THE NURSING STAFF FILED AN INCIDENT REPORT, BUT NIETHER RESPIRATORY THERAPY DEPT NOR BIOMED WERE NOTIFIED OR INVOLVED. THERE HAS NOT BEEN ANY SUBSEQUENT REPORTS ON A VENTILATOR SINCE 7/18/96, AT THIS HOSP.
THE SCREW ASSEMBLY COULD NOT BE FASTENED TO THE CHANNEL PLATE DURING SURGERY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: OPTICAL MICROSCOPY INSPECTION OF THE RETURNED SCREW NUT SCREW ASSEMBLY REVEALS THE SCREW THREADS ARE DEFORMED AND DAMAGED. THIS CONDITION WOULD SUGGEST A MISALIGNMENT DURING THE INSERTION OF THE SCREW INTO THE SCREW NUT. THE SCREW WAS NOT PERPENDICULAR TO THE SCREW NUT DURING ASSEMBLY STRIPPING THE SCREW THREADS AND RESTRICTING THE SCREW TO SEAT PROPERLY IN THE SCREW NUT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE EVAL RESULTS SUGGEST THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH HE DEVICE BUT RATHER WOULD BE RELATED TO ALIGNMENT DURING ASSEMBLY.
THE BATTERIES WERE REPORTEDLY OBSERVED TO NOT ALLOW DEFIBRILLATOR CHARGE TO 360 JOULES ON THREE ATTEMPTS DURING PT USE.
AT CONCLUSION OF THE EVENT THE FACILITY TESTED THE BATTERIES INSTALLED INTO THE DEFIBRILLATOR AND DETERMINED THEY WERE DISCREPANT. THE LOCAL CO SERVICE REP SUBSEQUENTLY OBSERVED PROPER DEFIBRILLATOR OPERATION, THROUGH FULL FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE. CODE #1085-LABLELD. EXCEPT AS PROVIDED BY 21 CFR 803.56, DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA.
THE SCREW WOULD NOT THREAD PROPERLY THROUGH THE HOLE OF THE NAIL. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
SUMMARY OF EVALUATION: EVALUATION RESULTS SUGGESTS THIS EVENT WOULD NOT BE DEVICE RELATED. THE DAMAGE PRESENT ON THE SCREW PROXIMAL AND DISTAL THREADED SECTIONS AS WELL AS THE SCREW TIP AND CUTTING FLUTES WAS MOST LIKELY THE CONTRIBUTING FACTORS FOR THE SCREW NOT ENGAGING THE CORTEX OF THE BONE.
THIS EVENT WAS REPORTED DURING THE INVESTIGATION OF ANOTHER REPORTED EVENT. DURING A PT USE, THE DEVICE DISPLAYED AN INAPPROPRIATE LEADS OFF MESSAGE AND A FLATLINE. NO OTHER INFO HAS BEEN PROVIDED BY REPORTER.
THE DEVICE WAS REPLACED TO ENHANCE CUSTOMER CONFIDENCE AND WILL NOT BE RETURNED TO THE CUSTOMER.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. THE INSTRUMENT DID NOT FIRE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/24/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
IT WAS REPORTED THAT WHILE TRYING TO LOAD A BALLOON CATHETER ONTO THIS GUIDE WIRE, RESISTANCE WAS MET. FURTHER INSPECTION REVEALED THAT THERE WAS WHAT APPEARS TO BE FOREIGN MATERIAL ON THE GUIDE WIRE. THE SYSTEM WAS REMOVED AND WAS NOT USED.
IT WAS DETERMINED THAT WHAT APPEARED TO BE FOREIGN MATERIAL ON THIS GUIDE WIRE WAS ACTUALLY HDPE FROM THE PTCA CATHETER.
THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY UNFOLDED. THE SHEATH WAS OBSERVED TO BE KINKED. LABORATORY EXAMINATION REVEALED NO DEFECTS IN THE RETURNED IAB. THE IAB FULLY INFLATED AFTER 2 CYCLES WHEN ATTACHED TO THE SYSTEM 90 IABP IN THE LAB. THE BALLOON SUBSEQUENTLY PUMPED SATISFACTORILY AT 80 & 160 BPM. NO ALARMS WERE TRIGGERED. PROBABLE CAUSE OF DIFFICULTY: THE EXACT CAUSE OF THE DIFFICULTY COULD NOT BE DETERMINED BASED ON THE EXAMINATION AND THE EVENT DESCRIPTION. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTY IN THE LAB. IN GENERAL, INFLATION DIFFICULTIES MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: THE PROXIMAL PORTION OF THE MEMBRANE REMAINED WITHIN THE SHEATH. THE BALLOON WAS PLACED TOO HIGH IN THE AORTIC ARCH OR IN THE SUBCLAVIAN ARTERY. THE BALLOON WAS PLACED SUBINTIMALLY. THE IAB FAILED TO COMPLETELY UNFOLD BECAUSE THE USER DID NOT INJECT AT LEAST 30 CC. OF AIR AS ADVISED IN THE INSTRUCTIONS FOR USE. THE CATHETER KINKED WITHIN THE PATIENT, POSSIBLY DUE TO A SEVERE VESSEL TORTUOSITY AND/OR PATIENT MOVEMENT. THE CATHETER KINKED OUTSIDE THE PATIENT. THE USER MAY HAVE NOT PROPERLY SECURED THE CATHETER AND Y-FITTING TO THE PATIENT. MANIPULATION OF THE KINKED PORTION OF THE CATHETER COULD HAVE MINIMIZED THE RESTRICTION AND ALLEVIATED THE PROBLEM. THERE WAS A LOOSE CONNECTION BETWEEN THE IAB AND THE PUMP OR BETWEEN THE PUMP AND THE SAFETY CHAMBER. CHECKING THESE CONNECTIONS MAY HAVE ALLEVIATED THE PROBLEM. HAVING THE OPPORTUNITY TO EXAMINE THE FOLDED BALLOON MEMBRANE MAY HAVE PROVIDED SOME ADDITIONAL INSIGHT INTO THE ENCOUNTERED DIFFICULTY.
AFTER THE IAB WAS INSERTED, THE BALLOON WAS FILLED AND PUMPING COMMENCED. FROM VIEW OF ARTERIAL WAVE FORM, AND THEN VIA FLUOROSCOPY, IT WAS NOTED THAT THE PROXIMAL END OF THE BALLOON HAD NOT UNWRAPPED. SEVERAL ATTEMPTS WERE MADE TO RE-FILL THE BALLOON, AND THEN MANUAL FILLING WAS PERFORMED WITHOUT SUCCESS. THE BALLOON WAS REMOVED AND A SECOND WAS NOT INSERTED. EVENT COMPLICATIONS: UNK - REPORTED 9/25/96; NONE - REPORTED 10/18/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 9/25, 10/18/96.
THE DISPOSABLE LOADING UNIT WAS USED WITH A STAINLESS STEEL INSTRUMENT DURING A HYSTERECTOMY PROCEDURE. THE STAPLES DID NOT LOCK PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE UNIT WAS BEING USED TO ROUTINELY MONITOR A PT DURING TRANSPORT. THE UNIT ALLEGEDLY DISPLAYED AN INAPPROPRIATE LEADS OFF MESSAGE AND A FLATLINE INSTEAD OF THE PT'S ECG.
THE DEVICE WAS APPLIED DURING AN OPEN HEART PROCEDURE. THE CLIPS  DID NOT ADVANCE PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE IAB WAS INSERTED WITH DIFFICULTY INTO THE PATIENT ON 9/22/96. ON 9/23/96 AFTER IABP FOR 22 HOURS, THE "RAPID GAS LOSS" ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED AND A SECOND WAS INSERTED INTO THE PATIENT. MULTIPLE EVENT TO COMPLAINT NUMBER 96-00157. EVENT COMPLICATIONS: UNK - REPORTED 10/18/96. PATIENT'S CURRENT STATUS: STABLE-RPT'D 10/18/96.
PT NEEDED TO BE DEFIBRILLATED. DEFIBRILLATOR DID NOT FIRE WHEN DISCHARGE BUTTONS WERE PUSHED. PT HAD TO BE DEFIBRILLATED WITH THE AMBULANCE SERVICE MODEL 10 DEFIBRILLATOR.
DEVICE LABEL CODES: 1738. A CLEAR, 10 FRENCH, 6 INCH HEMOSTASIS VALVE ASSEMBLY WAS RETURNED FOR EVALUATION WITH BLOOD NOTED ON THE EXTERIOR OF THE DEVICE. A KINK WAS NOTED IN THE SHEATH NEAR THE SHEATH/SHEATH HUB JUNCTION. THE I.D. OF THE SHEATH WAS MEASURED AND FOUND TO BE WITHIN DATASCOPE'S MFG SPECIFICATIONS. A SHEATH/SHEATH HUB LEAK TEST WAS PERFORMED ON THE ASSEMBLY ACCORDING TO DATASCOPE'S MFG SPECIFICATIONS. THE ASSEMBLY WAS VERIFIED TO BE WITHIN SPECIFICATION. USING A LABORATORY IAB, THE SHEATH/HEMOSTASIS VALVE ASSEMBLY WAS LEAK TESTED IN ORDER TO DETERMINE IF THE VALVE ASSEMBLY PROHIBITED THE BACK FLOW OF WATER THROUGH THE VALVE GASKET INTO THE STAT-GARD. AGAIN, THE ASSEMBLY PASSED THIS LEAK TEST. A 60CC. VACUUM WAS PULLED ON THE FOLDED MEMBRANE USING A LABORATORY SYRINGE AND A ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH THE RETURNED SHEATH/HEMOSTASIS VALVE ASSEMBLY WITHOUT DIFFICULTY. PROBABLE CAUSE OF DIFFICULTY: LABORATORY EXAMINATION OF THE RETURNED SHEATH/CLEAR HEMOSTASIS VALVE ASSEMBLY FOUND NO DEFECTS. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTY DURING LABORATORY EXAMINATION. IT WAS REPORTED THAT THE HEMOSTASIS VALVE LEAK OCCURRED WHEN THE GUIDEWIRE AND DILATOR WERE PULLED FROM THE SHEATH. THIS IS NOT A DEFECT AND SHOULD BE EXPECTED WHEN NO GUIDEWIRE OR IAB IS PRESENT. PRIOR TO THE BALLOON'S INSERTION THROUGH THE SHEATH/HEMOSTASIS VALVE ASSEMBLY, DILATOR - WHICH IS IN PLACE THROUGH THE HEMOSTASIS VALVE OR THROUGH THE SMALL HOLE IN THE HEMOSTASIS VALVE GASKET - WHEN THE DILATOR IS REMOVED (EVEN WITH THE GUIDE WIRE IN PLACE) DUE TO ARTERIAL PRESSURE. AGAIN, THIS SEEPAGE OF BLOOD SHOULD BE EXPECTED AND SHOULD NOT BE CONSIDERED A PRODUCT DEFECT. IT IS A NORMAL OCCURRENCE. THE VALVE GASKET IS PRESENT TO ONLY MINIMIZE THE FLOW OF BLOOD - NOT PREVENT IT. ONCE THE BALLOON IS INSERTED OVER THE GUIDE WIRE AND THE CATHETER TUBING IS PASSED THROUGH THE HEMOSTASIS VALVE ASSEMBLY, THE VALVE GASKET CREATES A TIGHT SEAL AGAINST THE CATHETER WALL TO PREVENT BLOOD FROM PASSING INTO THE STAT-GARD VIA THE SHEATH SEAL. ONLY THE BLUE DILATOR AND NOT THE GUIDEWIRE SHOULD NOT HAVE BEEN REMOVED FROM THE HEMOSTASIS VALVE. FINALLY, IT IS WORTH NOTING THAT THE NATURE OF EACH LEAK, AS PERCEIVED BY THE USER, WOULD NOT HAVE JEOPARDIZED BALLOON FUNCTION. INSERTION OF THE BALLOON PASSING THROUGH THE HEMOSTASIS VALVE (WHEN THE CATHETER IS IN PLACE) CAN BE PREVENTED FROM ENTERING INTO THE STAT-GARD VIA THE SHEATH SEAL IF A LIGATURE IS TIED AROUND THE GROOVE IN THE STAT-GARD WING.
EVENT COMPLICATIONS: UNK - REPORTED 9/26/96 AND 10/31/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 9/26, 10/31/96.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
REPORTEDLY, THE DEFIBRILLATOR WOULD NOT DISCHARGE ENERGY TO A PT WHEN THE PADDLES DISCHARGE BUTTONS WERE PRESSED. THE REPORTER STATED THE REPORTED EVENT DID NOT ADVERSELY AFFECT PT TREATMENT, DUE TO THE IMMEDIATE USE OF A BACKUP DEFIBRILLATOR.
THE FACILITY BIOMEDICAL DEPT EVALUATED THE REPORTED DEVICE AND OBSERVED PROPER OPERATION. AN OFFER OF DEVICE EVALUATION MADE TO THE FACILITY BY CO WAS DECLINED. THE DEVICE WAS RETURNED TO USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA.
WHEN AN ATTEMPT WAS MADE TO ANALYZE THE PT ECG, THE DEVICE REPEATEDLY PROMPTED CHECK PT AND ANALYSIS COULD NOT BE COMPLETED AS A RESULT.
CO IS CURRENTLY INVESTIGATING THE REPORTED MALFUNCTION. ADD'L INFO WILL BESUBMITTED TO THE FDA BY 12/16/96.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. LABORATORY EXAMINATION OF THE RETURNED ITEM REVEALED NO DEFECT. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. TESTING FOR OCCULT BLOOD WITHIN THE BALLOON WAS NEGATIVE. PROBABLE CAUSE OF DIFFICULTY: BASED ON THE EVENT DESCRIPTION AND PHYSICAL EVIDENCE, THERE WAS NO LEAK IN THE IAB. IT IS PROBABLE THAT DURING INSERTION BLOOD FLOWED BETWEEN THE FOLDS OF THE MEMBRANE AND EXITED NEAR THE CATHETER-MEMBRANE JUNCTION, LEADING TO THE PERCEPTION THAT THE BALLOON HAD LEAKED. DATASCOPE HAS INCORPORATED THIS CHANNELING PHENONOMEN IN ITS INSTRUCTIONS FOR USE FOR ALL STAT IABS.
UPON STARTING TO INSERT THE BALLOON, IT WAS NOTED THAT THE BALLOON HAD A HOLE. A SECOND IAB WAS INSERTED WITHOUT DIFFICULTY.
IT WAS REPORTED THAT AFTER SEVERAL SUCCESSFUL DILATIONS, THIS CORONARY GUIDE WIRE BECAME STUCK INSIDE THE PTCA CATHETER WITH WHICH IT WAS USED. UPON ATTEMPTING TO DISLODGE THE GUIDE WIRE, AFTER REMOVING THE SYSTEM FROM THE PT, BY PULLING ON THE PROXIMAL END OF THE GUIDEWIRE, IT STARTED TO UNRAVEL. THERE WERE NO RPEORTS OF COMPLICATIONS OR INJURIES RELATED TO THIS EVENT.
THIS DEVICE WAS LOST AND PRESUMED DISCARDED AFTER IT WAS RECEIVED BY CO. AN ANALYSIS OF THIS DEVICE WAS UNABLE TO BE PERFORMED. THE L/N WAS NOT INDICATED, DHR COULD NOT BE REVIEWED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SAFETY SHIELD DID NOT RETRACT WHEN APPLIED TO TISSUE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/24/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. THE PRODUCT WAS NOT RECEIVED FOR EVALUATION.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECTED TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY.
THE IAB WAS INSERTED INTO THE PATIENT ON 9/26/96. ON 9/28/96 AFTER IAB FOR TWO DAYS, BLOOD BACKED UP INTO THE IABP CATHETER TUBING. THE CONTACT REPORTED THAT THERE WERE NO COMPLICATIONS FROM THE EVENT. THE PATIENT WENT ON TO EXPIRE ON 10/4/96. EVENT COMPLICATIONS: UNK - REPORTED 9/30/96; NONE - REPORTED 10/18/96. PATIENT'S CURRENT STATUS: EXPIRED ON 10/4/96.
THE DEVICE WAS CONNECTED TO THE PT AND AN ATTEMPT TO PERFORM ECG RHYTHM ANALYSIS WAS MADE. THE DEVICE REPORTEDLY PROMPTED CHECK PT REPEATEDLY, AND ANALYSIS COULD NOT BE COMPLETED AS A RESULT.
THE LOCAL FACTORY SERVICE REP OBSERVED NO DEVICE DISCREPANCY RELATED TO THE REPORT. A FACTORY EVALUATION OF A CRITICAL EVENT RECORD MADE WITH THE DEVICE AT THE TIME OF THE REPORTED EVENT GAVE INDICATION THE DEVICE WAS FUNCTIONING WITHIN ITS PERFORMANCE CRITERIA DURING THE USE.
IT WAS REPORTED THAT WHILE DELATING A LESION IN THE MID RCA THE BALLOON OF THIS DEVICE BURST ON ITS 2ND INFLATION. THERE HAS BEEN NO CLAIM OF INJURY RELATED TO THIS EVENT.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. THE DEVICE COULD NOT BE CLOSED. THE SURGEON USED ANOTHER INSTRUMENT.
THE UNIT BURNED. CO'S INSPECTION REVEALED A 1/2" DIAMETER BURN HOLE CAUSED BY THERMOSTAT CONNECTIONS ARCING. NO DEATHS OR INJURIES WERE REPORTED. IT WAS REPORTED THE PT LAYED ON THE UNIT WHICH IS CONTRARY TO THE HOW-TO-USE BOOKLET OF INSTRUCTIONS.
THE IAB WAS INSERTED INTO THE PATIENT ON 9/17/96. ON 9/26/96 AFTER IABP FOR 10 DAYS, THE ALARM "IAB CATHETER" SOUNDED FROM THE PUMP. THE BALLOON WOULD NOT AUTOFILL AND BLOOD WAS NOTED IN THE TUBING. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. DATASCOPE WAS ALSO NOTIFIED THAT THE PATIENT WAS TAKEN TO SURGERY AND THE BALLOON WAS EXCHANGED WITH A THOMBECTOMY OF THE LEG. AFTER THE EVENT, THE PATIENT HAD GOOD PULSES AND COLOR. HOWEVER, THE PATIENT WENT ON TO EXPIRE ON 9/29/96. THE CONTACT REPORTED THAT THE EVENT WAS NOT RELATED TO THE PATIENT'S DEATH. EVENT COMPLICATIONS: UNK - REPORTED 9/27/96; THROMBECTOMY OF LEG - RPT'D 10/18/96. PATIENT'S CURRENT STATUS: EXPIRED - RPT'D 10/18/96.
HOSPITAL CARDIAC CATH LAB PERSONNEL WERE TREATING A PT FOR VENTRICULAR TACHYCARDIA WITH SYNCHRONIZED CARDIOVERSION. THE DEVICE WAS CONNECTED TO THE PT AND THREE COUNTERSHOCKS ADMINISTERED. THE PT'S ECG DETERIORATED TO VENTRICULAR FIBRILLATION. ACCORDING TO THE REPORTER, WHEN THE DEVICE'S CHARGE BUTTON WAS PUSHED FOR A FOURTH COUNTERSHOCK, THE DEVICE WOULD NOT CHARGE. A BACKUP DEFIBRILLATOR/MONITOR WAS CALLED FOR AND IMMEDIATEDLY USED. THE PT WAS RESUSCIATATED.
IN AN EVALUATION OF THE DEVICE BY THE LOCAL CO SERVICE REP, A COMPLETE FUNCTIONAL TEST WAS PERFORMED AND PROPER OPERATION WAS OBSERVED. THE HOSPITAL BIOMEDICAL DEPT REPLACED THE DEVICE'S BATTERY PAK AND RETURNED THE UNIT TO USE.
A STAPLER WAS APPLIED DURING A PNEUMONECTOMY PROCEDURE. THE INSTRUMENT WAS PLACED ACROSS THE SUPERIOR PULMONARY ARTERY AND THE HANDLE WAS COMPRESSED TWICE. BLEEDING WAS OBSERVED AS ONLY A PORTION OF THE STAPLES FORMED. THE SURGEON MANUALLY SUTURED TO CORRECT THE CONDITION. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
10/24/96-SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
IT WAS REPORTED THAT THIS CATHETER WAS USED TO DILATE A LESION IN THE LAD ARTERY USING THE KISSING BALLOON TECHNIQUE. THE OTHER BALLOON USED WAS ANOTHER MODEL, 3.00 MM PTCA CATHETER. THE BALLOON OF THIS DEVICE IS REPORTED TO HAVE BURST DURING THIS PROCEDURE. THIS DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS.
DUE TO THE PRESENCE OF BLOOD IN LUMEN, ONLY VISUAL INSPECTION WAS PERFORMED. THE DEVICE WAS USED OUT OF INDICATION. REVIEW OF THE DHR REVEALED NO RELATED COMMENTARY. THERE HAVE BEEN NO OTHER REPORTS OF THIS TYPE FOR THIS LOT.
THE SWITCH REMAINED IN THE "ON" POSITION. THE UNIT HAS NOT BEEN RETURNED TO CO TO BE INSPECTED AND MAY NOT BE. NO DEATHS OR INJURIES WERE REPORTED.
THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CFR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTEDTO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
THE PRODUCT WAS APPLIED DURING A VAGINAL HYSTERECTOMY. THE SUTURE BROKE AS KNOTS WERE BEING TIED. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
HOSPITAL PERSONNEL WERE PERFORMING A DAILY TEST OF THE DEVICE AND, ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS POWERED UP, A CRACKLING NOISE WAS HEARD AND SMOKE WAS SEEN EMITTING FROM THE DEVICE. THE REPORTER STATED THAT THE DEVICE WAS POWERED DOWN AND WOULD NOT POWER UP AGAIN.
IN AN EVALUATION OF THE DEVICE, THE HOSPITAL BIOMEDICAL DEPT OBSERVED BURNED ELECTRICAL COMPONENTS AND A LOOSE SPEAKER ASSEMBLY. FURTHER EVALUATION DETERMINED THE SCREW RETAINER FOR THE SPEAKER BRACKET HAD PULLED OUT OF THE CASE PLASTIC. THE DEVICE WAS REPAIRED BY THE FACILITY AND RETURNED TO USE. REPORTED EVENT IS NOT RELATED TO ANY FIELD ACTION FOR THE MODEL 10 DEFIBRILLATOR/MONITOR/PACEMAKER PERFORMED BY CO.
IT WAS REPORTED THAT AFTER THIS DEVICE WAS INITIALLY USED TO DILATE AN OM LESION AND WAS BEING INTRODUCED BACK INTO THE GUIDE CATHETER, THE DISTAL PORTION OF THE STIFFENING STYLET BENT AND RESULTED IN A FRACTURE OF THE CATHETER'S BODYSTOCK AT THAT POINT. THE DEVICE WAS NOT USED FURTHER. THERE HAS BEEN NO CLAIM OF INJURY RELATED TO THIS EVENT.
DEVICE DID NOT PUMP MEDICATION THROUGH THE LITTLE PUMP AND ON THROUGH TO THE PT. MEDICATION GOES INTO THE PUMP, BUT NOT THROUGH TO THE PT.
IT WAS DISCOVERED DURING SVC ACTIVITIES THAT A POTENTIAL DEVICE COMPATIBILITY CONCERN MAY RESULT WHEN DEVICES WITH THE NEWER POLE SAVER DESIGN ARE MOUNTED ON AN IV POLE WITH A DIAMETER OF 7/8" OR LARGER. IF A DEVICE WITH THE EARLY POLE SAVER DESIGN WAS MOUNTED ON THE LEFT SIDE, THE DEVICE MAY NOT ATTACH PROPERLY AND DROP UNEXPECTEDLY. THERE HAVE BEEN NO REPORTED PT INJURIES DUE TO THIS SITUATION.
FUNCTIONAL EVAL OF MODULAR CONNECTION SYSTEM INDICATED THAT THE ACTIVATOR ARM DID NOT FULLY RETRACT WHEN THE DEVICE WAS MOUNTED ON SOME IV POLES. THIS CONDITION MAY CAUSE THE ADD'L DEVICE, WHEN MOUNTED TO THE POLE MOUNTED DEVICE, TO NOT FULLY ENGAGE AND LOCK INTO PLACE. THIS MAY CAUSE THE DEVICE TO DISCONNECT AND DROP UNEXPECTEDLY. CORRECTION OF PROBLEM REQUIRES THE INSTALLATION OF A FIXTURE ONTO THE ACTIVATOR ARM WHICH WILL FULLY RETRACT THE ARM. THIS ALLOWS THE ADD'L PUMP TO BE ATTACHED AND LOCK SECURELY IN PLACE. THE INSTALLATION OF THE ACTIVATOR ARM FIXTURE WILL BE NOTIFIED TO FIELD VIA SAFETY ALERT AND CO WILL WORK WITH CUSTOMERS TO FACILITATE INSTALLATION.
SUBSEQUENT TO A LASER LITHOTRIPSY PROCEDURE A 3 CM PIECE OF FIBER WAS REPORTED TO HAVE BROKEN. THE SEGMENT WAS NOTED UNDER X-RAY TO BE OUTSIDE THE URETER, MEDIALLY IN THE RETROPERITONEUM. CO NOT AWARE OF ANY COMPLICATONS.
H3 BREAKAGE OF A SEGMENT OF FIBER DURING A PROCEDURE IS AN ADVERSE RISK, ASSOCIATED WITH THE PROCEDURE AS DESCRIBED IN PRODUCT LITERATURE. THE DRS CALL WAS RELATED TO CLINICAL SUPPORT INFO. D1,D6,A4,H1,H4-INFO HAS NOT BEEN MADE AVAILABLE, BUT IS EXPECTED.
IT WAS REPORTED THAT WHILE THIS CATHETER WAS BEING USED TO DEPLOY ANOTHER MFR'S CORONARY STENT, THE BALLOON OF THIS DEVICE BURST AT A PRESSURE ABOVE ITS RATED BURST PRESSURE. THERE WERE NO COMPLICATONS ASSOCIATED WITH THIS EVENT ANOTHER PTCA CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE CASE.
SEVERE RESPIRATORY DISTRESS AND FACIAL EDEMA AFTER EXPOSURE TO POWDERED LATEX SURGICAL GLOVES. PT REQUIRED TREATMENT WITH EPINEPHRINE AND OXYGEN.
WHEN THE GUIDE WIRE AND DILATOR WERE REMOVED A SMALL STEADY STREAM OF BLOOD LEAKED FROM THE HEMOSTASIS VALVE.
FOLLOW-UP MDR WAS MAILED TO THE FDA ON 4/25/97. DEVICE LABEL CODE FOR F10. POSITION 1: 1738 AND POSITION 2: 1738. EVALUATION SUMMARY: A CLEAR, 10 FRENCH, 6 INCH SHEATH/HEMOSTASIS VALVE ASSEMBLY WAS RETURNED FOR EVALUATION WITH BLOOD NOTED ON THE EXTERIOR OF THE DEVICE. THE ASSEMBLY WAS RETURNED WITH THE BLUE DILATOR IN PLACE THROUGH THE VALVE AND SHEATH. AFTER THE DILATOR WAS REMOVED, THE I.D. OF THE SHEATH WAS MEASURED AND FOUND TO BE WITHIN DATASCOPE'S MFG SPECIFICATIONS. A SHEATH/SHEATH HUB LEAK TEST WAS PERFORMED ON THE ASSEMBLY ACCORDING TO DATASCOPE'S MFG SPECIFICATIONS. THE ASSEMBLY WAS VERIFIED TO BE WITHIN SPECIFICATION. USING A LABORATORY IAB, THE SHEATH/HEMOSTASIS VALVE ASSEMBLY WAS LEAK TESTED IN ORDER TO DETERMINE IF THE VALVE ASSEMBLY PROHIBITED THE BACK FLOW OF WATER THROUGH THE VALVE GASKET INTO THE STAT-GARD. AGAIN, THE ASSEMBLY PASSED THIS LEAK TEST. A 60CC. VACUUM WAS PULLED ON THE FOLDED MEMBRANE USING A LABORATORY SYRINGE AND A ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH THE RETURNED SHEATH/HEMOSTASIS VALVE ASSEMBLY WITHOUT DIFFICULTY. PROBABLE CAUSE OF DIFFICULTY: LABORATORY EXAMINATION OF THE RETURNED SHEATH/CLEAR HEMOSTASIS VALVE ASSEMBLY FOUND NO DEFECTS. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTY DURING LABORATORY EXAMINATION. IT WAS REPORTED THAT THE HEMOSTASIS VALVE LEAK OCCURRED PRIOR TO THE INSERTION OF THE IAB CATHETER WHEN THE BLUE DILATOR AND GUIDEWIRE WERE REMOVED FROM THE VALVE AND SHEATH. PRIOR TO THE BALLOON'S INSERTION THROUGH THE SHEATH/HEMOSTASIS VALVE ASSEMBLY, IT IS QUITE NORMAL FOR BLOOD TO SEEP EITHER THROUGH THE SMALL HOLLOW BARREL OF THE BLUE DILATOR - WHICH IS IN PLACE THROUGH THE HEMOSTASIS VALVE OR THROUGH THE SMALL HOLE IN THE HEMOSTASIS VALVE GASKET - WHEN THE DILATOR IS REMOVED (EVEN WITH THE GUIDEWIRE IN PLACE) DUE TO ARTERIAL PRESSURE. AGAIN, THIS SEEPAGE OF BLOOD SHOULD BE EXPECTED AND SHOULD NOT BE CONSIDERED A PRODUCT DEFECT. IT IS A NORMAL OCCURRENCE. THE VALVE GASKET IS PRESENT TO ONLY MINIMIZE THE FLOW OF BLOOD - NOT PREVENT IT. ONCE THE BALLOON IS INSERTED OVER THE GUIDE WIRE AND THE CATHETER TUBING IS PASSED THROUGH THE HEMOSTASIS VALVE ASSEMBLY, THE VALVE GASKET CREATES A TIGHT SEAL AGAINST THE CATHETER WALL TO PREVENT BLOOD FROM PASSING INTO THE STAT-GARD VIA THE SHEATH SEAL. ONLY THE BLUE DILATOR AND NOT THE GUIDEWIRE SHOULD BE REMOVED FROM THE HEMOSTASIS VALVE. FINALLY, IT IS WORTH NOTHING THAT THE NATURE OF EACH LEAK, AS PERCEIVED BY THE USER, WOULD NOT HAVE JEOPARDIZED BALLOON FUNCTION. INSERTION OF THE BALLOON CATHETER OR GUIDEWIRE WOULD HAVE ALLEVIATED THIS FLOW OF BLOOD. IN ADDITION, ANY BLOOD PASSING THROUGH THE HEMOSTASIS VALVE (WHEN THE CATHETER IS IN PLACE) CAN BE PREVENTED FROM ENTERING INTO THE STAT-GARD VIA THE SHEATH SEAL IF A LIGATURE IS TIED AROUND THE GROOVE IN THE STAT-GARD WING.
PT WAS IMPLANTED APPROXIMATELY ONE YEAR AGO. SINCE THAT TIME, HE REPORTED THAT THE "FLUID LEAKED OUT" OF THE DEVICE. HE WAS A RESIDENT OF ONE STATE  AT THE TIME OF IMPLANT, HOWEVER HAS RELOCATED TO ANOTHER STATE AND IS IN  SEARCH OF A PHYSICIAN/SURGEON.
NO ADD'L INFO HAS BEEN RECEIVED AND NO APPARENT MEDICAL OR SURGICAL INTERVENTION HAS BEEN REPORTED WITH REGARDS TO THIS EVENT. SHOULD THE STATUS OF THIS PT CHANGE AND BE REPORTED TO THE MFR, AN ADDENDUM REPORT WILL BE FILED.
PUMP INTERMITTENTLY QUIT PUMPING. NURSE STARTED AND STOPPED THE PUMP REPEATEDLY UNTIL DOSE WAS ADMINISTERED.
WHILE INVESTIGATING A QUESTIONABLE VALUE FOR HEAD CIRCUMFERENCE ON AN OBSTETRICAL CALCULATIONS REPORT, THE INITIAL REPORTER FOUND THAT TWO DIGITS HAD BEEN OMITTED WHEN COMPARED TO THE DATA SAVED IN THE ULTRASOUND SYSTEM. THE DIGIT WAS OMITTED DURING TRANSMISSION OF THE ULTRASOUND DATA TO AN IMAGE AND DATA ACQUISITION SYSTEM. ENGINEERING TESTING HAS CONFIRMED THAT THE PROBLEM OCCURS INTERMITTENTLY AND INFREQUENTLY. THIS MEASUREMENT CAN BE USED IN DETERMINING FETAL WEIGHT AND GESTATIONAL AGE. BASED ON CONSULTATION WITH A PERINATOLOGIST, CO BELIEVES THE CHANCE OF SERIOUS INJURY IS REMOTE.
CO ENGINEERING DEPT CONTINUES TO INVESTIGATE THIS PROBLEM TO DETERMINE ITS ROOT CAUSE AND IDENTIFY CORRECTIVE ACTION. THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY OR DEATHS TO DATE. CO DOES NOT BELIEVE THAT IT IS LIKELY THAT A DEATH OR SERIOUS INJURY WILL OCCUR AS DEFINED IN THE FDA REGULATIONS. HOWEVER, TO BE CONSERVATIVE, CO DECIDED IN THE SPIRIT OF THE MDR REGULATIONS TO REPORT THIS MALFUNCTION. CUSTOMERS WILL BE NOTIFIED BY LETTER PENDING AVAILABILITY OF A SYSTEM UPGRADE THAT CORRECTS THE PROBLEM.
A CORONARY STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PT'S LEFT MAIN CORONARY ARTERY AND WAS SUBSEQUENTLY POST-DILATED. INTRAVASCULAR ULTRASOUND CONFIRMED OPTIMAL STENT EXPANSION AND VESSEL PATENCY. DURING WITHDRAWAL OF THE GUIDEWIRE, THE STENT DISLODGED FROM THE TARGET LESION SITE AND EMBOLIZED TO AN UNKNOWN LOCATION. NO FURTHER ACTIONS WERE TAKEN. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE SAFETY AND EFFICACY OF THE STENT WITH DELIVERY SYSTEM HAS NOT BEEN ESTABLISHED FOR PATIENTS WITH LESIONS LOCATED IN THE LEFT MAIN CORONARY ARTERY.
DURING ROUTINE CYSTO/BIOPSY METAL FRAGMENTS NOTED IN THE BLADDER VISEO DOCUMENTATION MADE. INSTRUMENTS TAKEN FROM SERVICE. BLADDER IRRIGATED WITH COPEOUS AMOUNT OF IRRIGATION. NO ADVERSE EFFECTS TO PT AT THIS TIME. THIS PROBLEM WITH MFR'S INSTRUMENTS IS ON GOING. SEVERAL MED WATCH FILED IN THE LAST 18 MONTHS.
THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 4/25/97. DEVICE LABEL CODE FOR F10. POSITION 1: 1738 AND POSITION 2: 1738. A CLEAR, 10 FRENCH, 6 INCH SHEATH/HEMOSTASIS VALVE ASSEMBLY WAS RETURNED FOR EVALUATION WITH BLOOD NOTED ON THE EXTERIOR OF THE DEVICE. THE ASSEMBLY WAS RETURNED WITH THE BLUE DILATOR IN PLACE THROUGH THE VALVE AND SHEATH. AFTER THE DILATOR WAS REMOVED, THE I.D. OF THE SHEATH WAS MEASURED AND FOUND TO BE WITHIN DATASCOPE'S MFG SPECIFICATIONS. A SHEATH/SHEATH HUB LEAK TEST WAS PERFORMED ON THE ASSEMBLY ACCORDING TO DATASCOPE'S MFG SPECIFICATIONS. THE ASSEMBLY WAS VERIFIED TO BE WITHIN SPECIFICATION. USING A LABORATORY IAB, THE SHEATH/HEMOSTASIS VALVE ASSEMBLY WAS LEAK TESTED IN ORDER TO DETERMINE IF THE VALVE ASSEMBLY PROHIBITED THE BACK FLOW OF WATER THROUGH THE VALVE GASKET INTO THE STAT-GARD. AGAIN, THE ASSEMBLY PASSED THIS LEAK TEST. A 60CC. VACUUM WAS PULLED ON THE FOLDED MEMBRANE USING A LABORATORY SYRINGE AND A ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH THE RETURNED SHEATH/HEMOSTASIS VALVE ASSEMBLY WITHOUT DIFFICULTY. PROBABLE CAUSE OF DIFFICULTY: LABORATORY EXAMINATION OF THE RETURNED SHEATH/CLEAR HEMOSTASIS VALVE ASSEMBLY FOUND NO DEFECTS. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTY DURING LABORATORY EXAMINATION. IT WAS REPORTED THAT THE HEMOSTASIS VALVE LEAK OCCURRED PRIOR TO THE INSERTION OF THE IAB CATHETER WHEN THE BLUE DILATOR AND GUIDEWIRE WERE REMOVED FORM THE VALVE AND SHEATH. PRIOR TO THE BALLOON'S INSERTION THROUGH THE SHEATH/HEMOSTASIS VALVE ASSEMBLY, IT IS QUITE NORMAL FOR BLOOD TO SEEP EITHER THROUGH THE SMALL HOLLOW BARREL OF THE BLUE DILATOR - WHICH IS IN PLACE THROUGH THE HEMOSTASIS VALVE OR THROUGH THE SMALL HOLE IN THE HEMOSTASIS VALVE GASKET - WHEN THE DILATOR IS REMOVED (EVEN WITH THE GUIDE WIRE IN PLACE) DUE TO ARTERIAL PRESSURE. AGAIN, THIS SEEPAGE OF BLOOD SHOULD BE EXPECTED AND SHOULD NOT BE CONSIDERED A PRODUCT DEFECT. IT IS A NORMAL OCCURRENCE. THE VALVE GASKET IS PRESENT TO ONLY MINIMIZE THE FLOW OF BLOOD - NOT PREVENT IT. ONCE THE BALLOON IS INSERTED OVER THE GUIDE WIRE AND THE CATHETER TUBING IS PASSED THROUGH THE HEMOSTASIS VALVE ASSEMBLY, THE VALVE GASKET CREATES A TIGHT SEAL AGAINST THE CATHETER WALL TO PREVENT BLOOD FROM PASSING INTO THE STAT-GARD VIA THE SHEATH SEAL. ONLY THE BLUE DILATOR AND NOT THE GUIDEWIRE SHOULD BE REMOVED FROM THE HEMOSTASIS VALVE. FINALLY, IT IS WORTH NOTING THAT THE NATURE OF EACH LEAK, AS PERCEIVED BY THE USER, WOULD NOT HAVE JEOPARDIZED BALLOON FUNCTION. INSERTION OF THE BALLOON CATHETER OR GUIDEWIRE WOULD HAVE ALLEVIATED THIS FLOW OF BLOOD. IN ADDITION, ANY BLOOD PASSING THROUGH THE HEMOSTASIS VALVE (WHEN THE CATHETER IS IN PLACE) CAN BE PREVENTED FROM ENTERING INTO THE STAT-GARD VIA THE SHEATH SEAL IF A LIGATURE IS TIED AROUND THE GROOVE IN THE STAT-GARD WING.
WHILE USING INSTRUMENT DURING LAPAROSCOPIC BURCH PROCEDURE JAWS OF INSTRUMENT SEPARATED FROM INSTRUMENT AND FELL INTO PT. BOTH JAWS WERE TRACED AND REMOVED FROM PT. NO APPARENT INJURY TO PT, BUT INCIDENT PROLONGED THE PROCEDURE.
CATH PLACED 7/12/96 VIA RT SUBCLAVIAN VEIN IN PT UNDERGOING COMBINED PREOP CHEMOTHERAPY/RADIATION FOR RECTAL CANCER. THERE WAS NO PROBLEM DURING HIS 6 WEEK COURSE OF TREATMENT. HE CAME IN ON 9/12/96 AND CATHETER WAS NOT FUNCTIONAL. CHEST X-RAY SHOWED DISTAL 2/3 OF CATHETER IN BRANCH OF PULMONARY ARTERY IN BASE OF RT LUNG. DR REMOVED THE PART LAST WEEK WHEN HE RESECTED HIS RECTAL TUMOR. THE TRANSECTED END OF CATHETER HAD A FLATTENED APPEARANCE.
WHILE INVESTIGATING A QUESTIONABLE VALUE FOR HEAD CIRCUMFERENCE ON A OBSTETRICAL CALCULATIONS REPORT, THE INITIAL REPORTER FOUND THAT A DIGIT HAD BEEN OMITTED WHEN COMPARED TO THE DATA SAVED IN THE ULTRASOUND SYSREM. THE DIGIT WAS OMITTED DURING TRANSMISSION OF THE ULTRASOUND DATA TO AN IMAGE AND DATA ACQUISITION SYSTEM. ENGINEERING TESTING HAS CONFIRMED THAT THE PROBLEM OCCURS INTERMITTENTLY AND INFREQUENTLY. THIS MEASUREMENT CAN BE USED IN DETERMINING FETAL WEIGHT AND GESTATIONAL AGE. BASED ON CONSULTATION WITH A PERINATOLOGIST, CO BELIEVES THE  CHANCE OF SERIOUS INJURY IS REMOTE.
CO ENGINEERING DEPT CONTINUES TO INVESTIGATE THIS PROBLEM TO DETERMINE ITS ROOT CAUSE AND IDENTIFY CORRECTIVE ACTION. THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY OR DEATHS TO DATE., CO DOES NOT BELIEVE THAT IS IS LIKELY THAT A DEATH OR SERIOUS INJURY WILL OCCUR AS DEFINED IN THE FDA REGULATIONS. HOWEVER, TO BE CONSERVATIVE, CO DECIDED IN THE SPIRIT OF THE MDR REGULATIONS TO REPORT THIS MALFUNCTION. CUSTOMERS WILL BE NOTIFIED BY LETTER PENDING AVAILABILITY OF A SYSTEM UPGRADE THAT CORRECTS THE  PROBLEM.
EVALUATION: A DATASCOPE STAGED GUIDEWIRE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION REVEALED SEVERE KINKS IN THE WIRE AT LOCATIONS OF 25" AND 26" DISTAL TO THE J-TIP END. UNDER MICROSCOPY, "FLAKING OFF" OF THE WIRE COATING WAS NOTED IN THESE KINKED AREAS. LABORATORY EXAMINATION DID VERIFY THE RPT'D DIFFICULTY. PROBABLE CAUSE OF DIFFICULTY: FLAKING OF THE WIRE COATING RESULTED WHEN THE WIRE WAS SEVERELY KINKED DURING IAB INSERTION INTO THE PT (WHEN THE BALLOON WAS INSERTED OVER THE GUIDEWIRE). IT WAS RPT'D THAT THE BALLOON USER DID NOT FOLLOW THE INSERTION GUIDELINES AS DESCRIBED IN DATASCOPE'S "INSTRUCTIONS FOR USE". FOLLOWING DATASCOPE'S INSERTION INSTRUCTIONS COULD HAVE MINIMIZED THE KINKING OF THE GUIDEWIRE AND CATHETER TUBING.
EVENT COMPLICATIONS: UNK - RPT'D 9/24/96. PT CURRENT STATUS: UNK - RPT'D 9/24/96.
AIR FLOW METER WOULD NOT WORK CORRECTLY.
THE PORTAL WAS RETURNED WITH A 3 INCH LENGTH OF CATHETER ATTACHED. VISUAL EXAMINATION OF THE CATHETER COMPONENT, USING MICROSCOPY. SHOWED THE DISTAL END OF THE CATHETER TO BE OVAL IN CROSS SECTION WITH A ROUGH SURFACE. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED COMPRESSION OF THE CATHETER, USUALLY BETWEEN THE CLAVICLE AND FIRST RIB. THIS PHENOMENA IS WELL DOCUMENTED IN MEDICAL LITERATURE.
MFR RECEIVED A FIRE INVESTIGATION REPORT INDICATING THAT A BED MOTOR CAUSED A FIRE. REPORTED INJURY IS NOT SERIOUS AS DEFINED IN THE REGULATION. THE MOTOR WAS NOT AVAILABLE FOR EVALUATION BY THE MFR AND SUBSEQUENT REPORTS INDICATE THE MOTOR HAS BEEN DISCARDED.
DEVICE LABEL CODE: 1701, 1738, 1701. EVALUATION: THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE BALLOON COMPLETELY UNFOLDED. LABORATORY EXAMINATION ON THE RETURNED ITEM REVEALED NO DEFECTS. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. AS A TEST, THE IAB WAS PLACED IN A TEST CHAMBER HAVING A 75 MMHG BACK PRESSURE TO SIMULATE THE PRESSURE WITHIN THE AORTA. THE IAB FULLY INFLATED AND FUNCTIONED NORMALLY WHEN ATTACHED TO THE SYSTEM 90 IABP IN THE LABORATORY. NO ALARMS WERE TRIGGERED ON THE PUMP. AFTER 2 MINUTES OF PUMPING, PRESSURE STRIPS WERE RECORDED. THE STRIPS CONFIRMED THAT THE BALLOON FULLY INFLATED AND DEFLATED SATISFACTORILY AT 80 AND 160 BPM DURING LABORATORY IABP TESTING. THUS, LABORATORY EXAMINATION REVEALED NO DEFECTS IN THE RETURNED IAB. PROBABLE CAUSE OF DIFFICULTY: IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED DIFFICULTY BASED ON THE EVENT DESCRIPTION AND EXAMINATION. IS IT POSSIBLE THAT THE USER PERCEIVED BLOOD WITHIN THE INNER LUMEN AS BLOOD WITHIN THE MEMBRANE? BLOOD NOTED ENTERING THE INNER LUMEN DURING IAB INSERTION IS A NORMAL OCCURRENCE AND NOT A PRODUCT DEFECT. THE INNER LUMEN CAN BE USED TO OBTAIN AN ARTERIAL WAVEFORM DURING IABP.
THE IAB WAS INSERTED INTO THE PATIENT ON 9/18/96. ON 9/19/96 AFTER IABP FOR OVER 61 HOURS, THE IABP WAS READING "LOW HELIUM TANK" (AUTOFILL FAILURE). THE TANK WAS CHANGED. THEN, THE ALARM "CHECK IABP CATHER" SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE CATHETER TUBING AND THE IAB WAS REMOVED. EVENT COMPLICATIONS: UNK - REPORTED 9/24/96; NONE - REPORTED 11/20/96. PATIENT'S CURRENT STATUS: DISCH'D 10/4 - RPT'D 11/20.
24 GAUGE CATHETER INSERTED INTO RIGHT MEDIAN CUBITAL VEIN WITH BLOOD FLASH BACK. 5CC NSS ATTACHED TO MIDLINE WITH STYLET REMOVAL CATHETER SECURED. PT WITHOUT COMPLICATIONS. 2ND 5CC NSS SYRINGE ATTACHED AND FLUSHED. UPON FLUSHING, 30 SEC LATER, PT COMPLAINED OF NAUSEA, TIGHTNESS IN CHEST, FACE RED, DIAPHORETIC VS TAKEN-HR 102, BP 100/110, RESP 22, HR PALPITATIONS/IRREGULAR. ALL CALLED. PARAMEDICS ARRIVED, VS TAKEN AGAIN; 108/60,92,18 AND HRR IRREGULAR WITH PVCS EVERY 7TH AND 8TH BEAT. TAKEN TO ER FOR FURTHER FOLLOW UP.
THE STYLET COULD NOT BE ADVANCED TO THE TIP OF THE LEAD. THE LEAD WILL BE RETURNED. THE DEVICE WAS NOT IMPLANTED.
BOTH SIZES OF STYLETS COULD BE ADVANCED TO THE TIP WITHOUT DIFFICULTIES. THE OUTER COIL IS SLIGHTLY KINKED, BUT THE INNER COIL IS NOT. CANNOT VERIFY COMPLAINT.
ALL BUTTONS ON PUMP NON-FUNCTIONAL. PUMP IS PROGRAMMED; HOWEVER, NURSE CANNOT START PUMP. REQUIRED IMMEDIATE PUMP REPLACEMENT.
DOSE BUTTON ON PUMP MALFUNCTIONING. WILL NOT ACTIVATE WHEN PUSHED. RQUIRED PUMP REPLACEMENT.
DURING A FOLLOW-UP ON 8/8/96, THE PROGRAMMER COULD NOT COMMUNICATE WITH THE PACER. ON 8/15/96, WHEN USING A DIFFERENT PROGRAMMER, COMMUNICATION WAS ESTABLISHED WITHOUT ANY PROBLEM. THEN WHEN TRYING TO USE ANOTHER 522-12, NO COMMUNICATION WAS ESTABLISHED. THE DEVICE WILL BE MONITORED IN THE PT'S BODY.
THE PT HAD CABG SURGERY ON 7/10/96. HER CONDIDTION DETERORATED WITH LOW BLOOD PRESSURE AND RESPIRATORY DISTRESS. A IAB WAS INSERTED AT THE PT'S BEDSIDE ON 7/12/96 AROUND 3:00 AM. A LEAK WAS NOTED IN THE BALLOON AROUND 10:30 TO 11:00 AM AND THE IAB WAS REOVED. A SECOND IAB WAS INSERTED AROUND 6:00 PM ON 7/12/96. EVENT COMPLICATIONS: UNKNOWN-REPORTED 9/23/96. PT'S STATUS-UNKNOWN-RPT'D 9/23/96.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738 AND POSITION 2: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION INSPITE OF NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR THE RETURN OF THE PRODUCT.
RESIDENT WEARING CALL PENDANT. FELL IN BATHROOM. PENDANT DID NOT WORK. BUTTON ON PENDANT HAS PUSHED IN SO RESIDENT UNABLE TO PUSH. THIS RESULTED IN RESIDENT LYING ON FLOOR FOR 1-2 HRS BEFORE SOMEONE FOUND HER.
THE DEVICE WAS REMOVED AS IT "WOULDN'T DEFLATE", SECONDARY TO "SEVERE SCARRING CAUSED BY A PERITONEAL ABCESS". AS REPORTED TO CO THE RESERVOIR ONLY WAS REMOVED AND REPLACED.
EVAL IS PENDING DECONTAMINATION, EXAMINATION AND TESTING OF THE RETURNED DEVICE COMPONENTS. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUA FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION.
IT WAS REPORTED THAT THE "BALLOON NOT FULLY UNWRAPPED" AND "HI BASELINE" ALARMS ON THE PUMP ACTIVATED. THE PT WAS TRANSFERRED TO ANOTHER PUMP AND THERE WERE NO PT COMPLICATIONS.
THE FIELD SERVICE REP INVESTIGATED THIS INCIDENT. HE REPLACED THE IMS DRIVER AND RAN A FUNCTIONAL CHECK ON THE PUMP. ALL FUNCTIONS WERE NORMAL.
DURING SERVICE OF PRODUCT A MOTOR STALL WITH CONTINUOUS AUDIBLE LOW PRESSURE ALARM, WAS FOUND DUE TO A LIQUID SPILL. UNAUTHORIZED REPAIRS TO MANIFOLD WERE ALSO PERFORMED BY FIELD SERVICE PERSONNEL. DEVICE RETURNED UN REPAIRED AT CUSTOMER'S REQUEST. MFR INFORMED CUSTOMER THAT IT DOES NOT RECOMMEND DEVICE FOR PT USE UNITL PROPER REPAIRS HAVE BEEN PERFORMED BY AUTHORIZED PERSONNEL. MFR DISABLED DEVICE PRIOR TO RETURNING IT TO CUSTOMER.
H6. 100-FAILURE MODE CAUSED BY LIQUID SPILL. H.6 68-DEVICE RETURNED UNREPAIRED AT CUSTOMERS REQUEST. LABELING-#1738.
SUBGALEAL HEMATOMA IN TERM NEONATE FOLLOWING VACUUM EXTRACTION. REQUIRED VIGOROUS FLUID RESUSCITATION AND A 12 DAY HOSPITALIZATION, HAD SEIZURES AS WELL, BUT IS NOW OFF OF ANTICONVULSANT MEDICATIONS.
TERM NEONATE WITH SHOULDER DYSTOCIA AND SUBGALEAL HEMATOMA FOLLOWING VACUUM EXTRACTION AT A BIRTH CENTER FIXED PUPILS AND NO REFLEXES FROM TIME OF BIRTH. DEATH OCCURRED ON 2ND DAY OF LIFE.
REPORT OF ALLEGED "NO LOW PRESSURE ALARM WHEN EXHALATION VALVE TUBING IS DISCONNECTED. FOUND DURING INITIAL CHECK OUT".
LABELING #1738. TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL.
DEVICE LABEL CODE FOR F10. POSITION 1: 1701 AND POSITION 2: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION INSPITE OF NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR THE RETURN OF THE PRODUCT.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 9/23/96. PATIENT'S CURRENT STATUS: O.K. - RPT'D 9/23/96.
SUBGALEAL HEMATOMA IN A TERM FEMALE INFANT FOLLOWING USE OF METAL VACUUM DEVICE TO DELIVER INFANT. RESULTANT DIC AND HYPOVOLEMIC SHOCK, REQUIRED MASSIVE TRANSFUSIONS. PROGRESSED WITH NEUROLOGIC DETERIORATION TO BRAIN DEATH ON DAY OF LIFE #3.
UPON DEPLOYMENT, THE FILTER LEGS BECAME CROSSED. THE DOME FORMED, HOWEVER ONLY TWO LEGS BECAME ATTACHED TO THE WALL. A CT SCAN WAS PERFORMED ON 9/20/96, THE FILTER IS STILL IN TARGET LOCATION AND IS IN THE SAME CONDITION.
UPON DEPLOYMENT, THE FILTER LEGS BECAME CROSSED. THE DOME FORMED, BUT ONLY TWO LEGS BECAME ATTACHED TO THE WALL. THE DIMENSIONS OF THE TARGET LOCATION WERE 2MM CAVA WALL AND 27-28MM IN DIAMETER. SAMPLE RECEIVED WAS A SET OF ANGIOGRAPHY FILMS. FILTER DOME DEPLOYED CORRECTLY. TWO FILTER LEGS CROSSED AGAINST THE VENA CAVAL WALL. IT IS POSSIBLE THAT THE LEGS CAN BECOME CROSSED WHILE LOADING THE FILTER INTO THE STORAGE TUB. THIS CAN CAUSE THE LEGS TO CROSS UPON DEPLOYMENT. FILTER DOME DEPLOYED CORRECTLY. FILTER LEGS CROSSED AND DIVIDED INTO TWO 3-LEG SETS AGAINST THE VENA CAVAL WALL.
TERM NEWBORN INFANT WITHOUT OTHER ANOMALIES DEVELOPED SUBGALEAL HEMATOMA AFTER VACUUM DEVICE. NEUROLOGIC STATUS DETERIORATED TO FIXED DILATED PUPILS,APNEA, AND NO CEREBRAL BLOOD FLOW TO HALF OF HIS BRAIN. HE DIED ON DAY 5 OF LIFE.
THE DILATOR SHEATH WAS OBSERVED TO BE KINKED UPON REMOVAL FROM THE PACKAGE. THE DEVICE WAS NOT USED ON THE PT.
SUBAGALEAL HEMATOMA FOLLOWING VACUUM EXTRACTION LEADING TO HYPOVOLEMIC SHOCK REQUIRING MULTIPLE BLOOD PRODUCT TRANSFUSION. DIED ON HER 11TH DAY OF LIFE DUE TO MULTI ORGAN SYSTEM FAILURE.
SUBGALEAL HEMATOMA FOLLOWING VACUUM EXTRACTION ATTEMPT AT DELIVERY. RESULTING HYPOVOLEMIC SHOCK, DIC, RENAL FAILURE. INFANT REQUIRED ALMOST CONTINOUS BLOOD, FFP, AND PLATELET TRANSFUSIONS FOR SEVERAL DAYS. AT 3 WEEKS  AT AGE HE STILL REQUIRES DIALYSIS DUE TO RENAL FAILURE.
IT WAS REPORTED A BALLOON RUPTURED ON THE FIRST INFLATION DURING AN ILIAC ANGIOPLASTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. SINCE CO FOLLOW UP INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION, CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO DIRECTIONS FOR USE STATE: "DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON, BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY".
IT WAS REPORTED TO CO THAT THE CINE CAMERA FAILED DURING A CARDIAC CATHETERIZATION PROCEDURE. APPARENTLY THIS PREVENTED THE PROCEDURE FROM BEING COMPLETED AND THE PT WAS RETURNED TO HER ROOM. NO INJURY WAS REPORTED.
ON 10/18/96 DATASCOPE RECEIVED THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT NUMBER: 33-0119-1996-0001. EVENT COMPLICATIONS: <NONE FROM THE EVENT - REPORTED 9/23/96, 10/18/96.> PATIENT'S CURRENT STATUS: <EXPIRED - RPT'D 9/23/96.>
IT WAS REPORTED THAT A BALLOON LEAKED DURING TESTING. ANOTHER UNIT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PT COMPLICATIONS. THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE EVAL INDICATED THE SHAFT OF THE BALLOON WAS BOWED. MICROSCOPIC EXAMINATION REVEALED A PIN HOLE LOCATED IN THE DISTAL TRANSITION ZONE THREE MILLIMETERS DISTAL TO THE DISTAL RADIOPAQUE MARKER. THE BALLOON SURFACE WAS SCRATCHED. BALLOON RUPTURE OR BALLOON LEAK IS AN ANTICIPATED EVENT OF ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVER-PRESSURIZATION OR USE IN A HIGHLY CALCIFIED LESION. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTANT WITH OVERPRESSURIZATION, A BOWED SHAFT UNDER THE BALLOON AS WELL AS CONTACT WITH A SHARP EXTERNAL SOUCE, SCRATCHES ON THE BALLOON SURFACE. THEREFORE, CO DOES ATTRIBUTE THIS EVENT TO THE DEVICE. CO DIRECTIONS FOR USE STATE: "IF LOWS OF PRESSURE WITHIN THE BALLOON CATHETER OCCURS DURING INFLATION OR IF THE BALLOON RUPTURES DURING DILATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY. INFLATION IN EXCESS OF THE RATED BURST PRESSURE MAY CAUSE BALLOON TO TUPTURE".
IT WAS REPORTED AN INTRA-AORTIC BALLOON DEVELOPED A LEAK AND ANOTHER INTRA-AORTIC BALLOON CATHETER WAS PLACED. THERE WERE NO PT COMPLICATIONS INVOLVED. NO FURTHER DETAILS COULD BE OBTAINED REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. THE DEVICE WAS REC'D EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE CENTRAL LUMEN WAS DAMAGED IN SEVERAL LOCATIONS. INFLATION OF THE BALLOON WAS NOT POSSIBLE. MICROSCOPIC EXAMINATION DID NOT REVEAL ANY BALLOON ANOMALIES. ALL CATHETERS ARE 100% LEAK TESTED DURING PRODUCTION. CO BELIEVES THE LEAK OCCURRED EXTERNAL TO THE MFG PROCESS. MISHANDLING OF THE DEVICE MAY RESULT IN THIS TYPE OF CATHETER DAMAGE. THEREFORE, CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE.
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MANUFACTURER BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
THE CIN WAS CONTACTED DIRECTLY BY THE CONTACT PERSON AT THE HOSPITAL. IT WAS REPORTED "THE MCA20 WOULD NOT CLIP APPROPRIATELY" DURING A RIGHT MASTECTOMY. THERE WAS NO ADVERSE PT OUTCOME.
A1,2,3,4; B6,7; D10 INFO AVAILABLE AFTER FOLLOW UP. D5,6; H4,6 INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THAT A BALLOON DETACHED FROM THE CATHETER SHAFT DURING PREPARATION BEFORE THE PROCEDURE. THERE WAS NO PT CONTACT. THE PROCEDURE WAS RESCHEDULED. THE DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE BALLOON WAS DETACHED FROM THE SHAFT AT THE PROXIMAL END OF THE PROXIMAL SLEEVE. THE AREA OF SEPARATION APPEARS TO BE SMOOTH AND THERE IS NO EVIDENCE OF SHAFT ELONGATION. THE SHAFT WAS SUPPLE AND FLEXIBLE. NO CAUSE COULD BE DETERMINED FOR THIS BALLOON/CATHETER SEPARATION BASED ON CO'S AEVAL OR FOLLOW UP INFO OBTAINED. NO OTHER COMPLAINTS ON THIS LOT NUMBER HAVE REC'D TO DATE. CO THIS TO BE AN ISOLATED INCIDENT. ALL CATHETERS ARE FLEX TESTED TO ENSURE BOND INTEGRITY DURING CO MFG PROCESS.
IT WAS REPORTED TO CO THAT FLUOROSCOPY FAILED ON THE SYSTEM DURING A PTCA PROCEDURE. APPARENTLY IMAGE LOSS HAPPENED AFTER A VESSEL DISSECTION OCCURRED. THE PT UNDERWENT EMERGENCY OPEN HEART SURGERY TO REPAIR THE VESSEL DISSECTION.
CUSTOMER ELECTED NOT TO HAVE EQUIPMENT EVALUATED. THE INFO CONTAINED IN THE MDR IS OF A TYPE CUSTOMARILY HELD IN STRICT CONFIDENCE AND REGARDED AS PRIVILEDGED BY GE UNDER 21 CFR 20.61. THEREFORE, GE REQUESTS THAT THE FOOD AND DRUG ADMINISTRATION TREAT THAT PORTION OF THE MDR RELATING SPECIFICALLY TO THE PRODUCT AS CONFIDENTIAL COMMERCIAL INFO UNDER 21 CFR 803.9(B). THE INFO CONTAINED IN THE SUBJECT REPORT(S) HAS NOT BEEN SUBSTANTIATED BY THE GENERAL ELECTRIC COMPANY. THE CONTENT OF THE REPORT(S) DOES NOT CONSTITUTE AN ADMISSION BY THE GENERAL ELECTRIC COMPANY THAT A DEVICE HAS MALFUNCTIONED NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A DEVICE AND A DEATH OR INJURY.
PHYSICIAN REPORTEDLY FOUND TELESCOPE TOO SHORT FOR HIS PROCEDURE AND ATTEMPTED TO PUSH IT IN; STOPCOCK HANDLE CONTACTED PATIENT; PATIENT SUSTAINED TINY BURN ON GLANS.
OPERATING & MAINTENANCE MANUAL STATES: "KEEP METAL PARTS OF THE ENDOSCOPE FROM SAMLL AREA (LESS THAN 1/2 SQ. IN.) CONTACT WITH THE PT".
THE PRODUCT WAS APPLIED DURING A VAGINAL HYSTERECTOMY. THE SUTURE BROKE AS KNOTS WERE BEING TIED. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP AHS REPORTED THAT NO PT INJURY OCCURRED.
10/24/96- MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
(THIS FOLLOW-UP MDR WAS MAILED TO FDA ON 5/27/97). DEVICE LABEL CODE FOR F10. POSTION 1: 1738. EVAL SUMMARY. EVAL: IAB WAS RECEIVED INTACT FOR EVAL WITH BALLOON MEMBRANE NOTED TO BE LOOSELY FOLDED. AS A TEST, IAB WAS PLACED IN A TEST CHAMBER HAVING A 75 MMHG BACK PRESSUEE TO SIMULATE PRESSURE WITHIN AORTA. BALLOON PUMPED SATISFACTORILY AT 80 AND 160 BPM. NO ALARMS WERE TRIGGERED ON PUMP. AFTER 2 MINUTES OF PUMPING, PRESSURE STRIPS WERE RECORDED. STRIPS CONFIRMED THAT BALLOON FULLY INFLATED AND DEFLATED SATISFACTORILY AT 80 AND 160 BPM DURING LAB IABP TESTING. THUS, LAB EXAMINATION REVEALED NO DEFECTS IN RETURNED IAB. PROBABLE CAUSE OF DIFFICULTY: SINCE NO DEFECT WAS FOUND DURING LAB TESTING, IT IS NOT POSSIBLE TO DETERMINE EXACT CAUSE OF REPORTED DIFFICULTY BASEN ON EVENT DESCRIPTION AND EXAMINATION OF ITEM. IT WAS NOT POSSIBLE TO VERIFY REPORTED PROBLEM. THIS TYPE OF COMPLAINT IS ONE OF MOST DIFFICULT TO EVALUTATE AND MUST RELY ON CONJECTURE SINCE ONE CANNOT OBSERVE WHAT BALLOON IS BEING SUBJECTED TO WITHIN AORTA. THUS, IN GENERAL, INFLATION DIFICULTIES MAY ATTRIBUTED TO ONE OR MORE OF FOLLOWING: 1. BALLOON ENTERED A SUBINTIMAL SPACE. 2. BALLOON WAS PLACED TOO HIGH IN AORTIC ARCH OR IN SUBCLAVIAN ARTERY. 3. IAB FAILED TO COMPLETELY UNFOLD BECAUSE USER FAILED TO INJECT 30 CC. OF AIR AS ADVISED IN INSTRUCTIONS FOR USE. 4. CATHETER KINKED WITHIN PT PROBABLY BECAUSE OF SEVERE VESSEL TORTUOSITY AND/OR PT MOVEMENT. 5. CATHETER KINKED OUTSIDE PT. USER MAY HAVE FAILED TO SECURE CATHETER AND Y-FITTING TO PT. MANIPULATION OF KINKDED PORTION OF CATHETER COULD HAVE MINIMIZED RESTRICTION AND IMPROVE BALLOON PERFORMANCE. 6. A KINK IN CATHETER MAY HAVE RESTRICTED FLOW OF HELIUM INTO AND OUT OF BALLON CAUSING IT TO NOT FULLY INFLATE DURING INITIATION OF IABP. 7. THERE WAS A LOOSE CONNECTION BETWEEN IAB AND PUMP OR BETWEEN PUMP AND SAFETY CHAMBER. CHECKING THESE CONNECTIONS MAY ALLEVIATE PROBLEM. 8. BALLOON PUMP NEEDED SERVICING.
THE FOLLOWING WAS REPORTED TO DATASCOPE ON 1/3/97: CATHETER WAS BROKEN WHEN BOX WAS OPENED. THERE WAS NO PT INVOLVEMENT. IAB DID NOT INFLATE. A REPLACEMENT CATHETER WAS PULLED AND USED WITHOUT INCIDENT. EVENT COMPLICATIONS: UNK - RPT' 9/24/96; NONE FROM EVENT - RPT'D 1/3/97. PT'S CURRENT STATUS: UNK - RPT'D 9/24/96.
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
9/25/96 DR. R. CONFIRMED THE INFO AS REPORTED BY THE REP. THE CLIPS WERE RETRIEVED FROM THE PT AND THERE WAS NO CONSEQUENCE TO THE PT. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. TSB
IT WAS REPORTED TO CO THAT AN ERROR IN THE SOFTWARE PACKAGE WHICH IS A PART OF THE DEVICE 3D SOFTWARE PACKAGE, MAY PRODUCE IMAGE ORIENTATION AND ANNOTATION ERRORS THAT CAUSE THE IMAGE TO BE REVERSED UNDER CURVED REFORMAT APPLICATIONS.
PURCHASING AGENT REPORTED, ANESTHESIOLOGIST OBSERVED TUBING ON ANESTHESIA BREATHING CIRCUIT TO BE KINKED, PRIOR TO USE WITH PT.
UPON COMPLETION OF FAILURE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.
DEVICE LABEL CODES: 1738, 1701. UNDERWATER LEAK TESTING DICLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGE PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 9/24/96 AND 10/18/96. PATIENT'S CURRENT STATUS: GOOD - RPT'D 10/18/96.
IT WAS REPORTED THE DEVICE WAS USED DURING A PARAESOPHAGEAL HERNIA PROCEDURE. IT WAS REPORTED THE MCL20 FIRED SUCCESSFULLY, THEN CLIPS BEGAN TO SCISSOR ON SUBSEQUENT FIRINGS. AN MCM20 WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
A1,2,3,4; B6,7: D10 INFO UNAVAILABLE. D5,6; H4,6 INFO UNAVAILABLE AT THIS TIME.
THE IAB WAS INSERTED INTO THE PT ON 9/20/96. ON 9/21/96, BLOOD WAS NOTED N THE SHUTTLE TUBING AND THE IABP WAS NOT FUNCTIONING. THE BALLOON WAS PLACED IN STAND-BY MODE. THE IAB WAS REMOVED AND ANOTHER IAB WAS INSERTED. EVENT COMPLICATIONS: NONE FROM THE EVENT - RPT'D 9/23/96 AND 10/11/96. PT CURRENT STATUS: O.H.S ON 9/25; ON IABP.
THE ANESTHESIA BREATHING CIRCUIT WAS SUSPECTED OF CONTAINING PIN HOLES IN ITS CORRUGATED HOSE WHICH WOULD CAUSE IT TO LEAK.
USER SUSPECTED PIN HOLES IN CIRCUIT DURING PRE-ANESTHESIA SETUP TESTING (AS INSTRUCTED BY PRODUCT'S POLYBAG LABELING). THERE WAS NO PT INVOLVEMENT. LEAK TESTS WERE PERFORMED ON TWO RETURNED BREATHING CIRCUITS. ONE CIRCUIT WAS FOUND TO LEAK IN EXCESS OF CO'S ESTABLISHED CRITERIA. VISUAL EXAMINATION OF THE LEAKING CIRCUIT FOUND UNUSUAL EXTERNAL PHYSICAL DAMAGE TO THE CORRUGATED HOSE AND HOSE CUFF. CO HAS BEEN UNABLE TO DETERMINE THE EXACT CAUSE OF THIS DAMAGE. THE DEFECT IS NOT CONSIDERED TO REPRESENT A SIGNIFICANT HEALTH HAZARD BUT COULD CAUSE A MINOR DELAY IN INITIATING AN ANESTHESIC PROCEDURE.
THE PRODUCT WAS APPLIED DURING A VAGINAL  HYSTERECTOMY. THE SUTURE BROKE AS KNOTS WERE BEING TIED. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A TOTAL ESOPHAGECTOMY PROCEDURE. THE INSTRUMENT JAMMED AND CLIPS DID NOT FORM PROPERLY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
REPORTED THAT PENCILS ARE "PERIODICALLY MALFUCTIONING. THEY WILL WORK FOR AWHILE AND THEN STOP WORKING.
THE ACTUAL DEVICE WAS RETURNED TO CO AND TESTED ON 10/4/96, AND AGAIN ON 10/7/96. CO WAS UNABLE TO CONFIRM OR DUPLICATE THE REPORTED EVENT. THE PENCIL WAS DISASSEMBLED ON 10/7/96, AND NO EVIDENCE OF DEFECT WAS FOUND.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
IT WAS REPORTED THE EZ45 WAS USED DURING A THORACTOMY WITH A WEDGE RESECTION. THE FIRST EZ45 WOULD NOT FIRE PROPERLY AND BROKE. THE SECOND EZ45 CARTRIDGE FELL OUT OF THE JAWS AND INTO THE PT. ANOTHER EZ45 WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
D6: CORRECTION TO THE CATALOG # AND DEVICE RETURNED WITH NO LOT ID. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. INSTRUMENT A WAS RETURNED IN GOOD PHYSICAL CONDITION. INSTRUMENT A WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. INSTRUMENT A WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. INSTRUMENT B WAS RETURNED WITH A BROKEN PINION GEAR AND A BENT KNIFE. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. NO TESTING COULD BE PERFORMED ON B DUE TO THE CONDITION OF THE INSTRUMENT RETURNED. THE CARTRIDGE RETENTION FEATURE OF BOTH INSTRUMENTS WERE MEASURED AND WAS FOUND TO BE WITHIN DESIGN SPECIFICATION. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. A COMPONENT FROM THE TROCAR DISENGAGED INTO THE PT'S CAVITY. THE SURGEON RETRIEVED THE PIECE WITHOUT PT INJURY. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.
10/24/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
A PT HAD BEEN RECEIVING UNIVENTRICULAR SUPPORT WITH A VENTRICULAR ASSIST DEVICE (VAD) SINCE 8/5/96 (64 DAYS). WHILE CROSSING A DOOR THRESHOLD DURING PT AMBULATION, LOUD COMPRESSOR NOISE AND THE SOUND OF AN AIR LEAK WAS HEARD. THE DRIVE CONSOLE WAS RECONNECTED TO HOSPITAL COMPRESSED AIR AND VACUUM WITHOUT ANY PT COMPROMISE. UPON INVESTIGATION, A DISCONNECTED PRESSURE TUBING FITTING WAS FOUND AT THE COMPRESSOR PROVIDING PRESSURE TO THE BACK-UP DRIVE MODULE FOR THE VAD.
WHEN THE BACK-UP VAD DRIVE MODULE WAS NOTED TO HAVE NO DRIVE PRESSURE AVAILABLE FROM THE COMPRESSOR THE HOSPITAL IMMEDIATELY CONTACTED CO FIELD SERVICE. FIELD SERVICE PERSONNEL INSTRUCTED THE HOSPITAL BIOMEDICAL ENGINEER TO CHECK SEVERAL SOURCES FOR THE PROBLEM, INCLUDING THE PRESSURE TUBING BETWEEN THE COMPRESSORS AND THE DRIVE MODULES. THE HOSPITAL BIOMEDICAL ENGINEER NOTED THAT THE PRESSURE TUBING TO ONE DRIVE MODULE WAS TOTALLY DISCONNECTED FROM ITS FITTING AND THE PRESSURE TUBING TO THE OTHER MODULE WAS STILL CONNECTED TO ITS FITTING, BUT LOOSE. THE PRESSURE TUBING WAS RECONNECTED AND THE FITTINGS TIGHTENED, WHEREUPON THE DRIVE CONSOLE RESUMED PROPER OPERATION. A CO FAILURE INVESTIGATION WAS INITIATED AND DETERMINED THAT THE REPORTED FAILURE WAS DUE TO AN ASSEMBLY ERROR DURING MANUFACTURE OF THE COMPRESSOR TRAY SUB-ASSEMBLY OF THE VAD DRIVE CONSOLE. THE FITTINGS CONNECTING THE PRESSURE TUBING FROM THE COMPRESSORS TO THE DRIVE MODULES HAD NEVER BEEN TIGHTENED, ALLOWING THE TUBING TO DISCONNECT FROM THE COMPRESSOR WHEN UNDER PRESSURE. A REVIEW OF THE DEVICE HISTORY RECORDS AND FINISHED ASSEMBLIES REVEALED THAT THE ASSEMBLY ERROR WAS ASSOCIATED WITH TWO NEW OPERATORS. PREVIOUSLY, THIS ASSEMBLY HAD BEEN PERFORMED BY ONLY TWO OTHER PEOPLE OVER THE LAST TWELVE YEARS WITH NO REPORTED FAILURES OF THIS TYPE. NINETEEN VAD DRIVE CONSOLES WERE IDENTIFIED AS HAVING COMPRESSOR TRAYS ASSEMBLED BY THE TWO NEW OPERATORS. THE VAD SYSTEM IS A LIFE SUPPORTING DEVICE AND A SUDDEN COMPLETE LOSS OF VAD DRIVE PRESSURE COULD RESULT IN SERIOUS INJURY OR DEATH. HOWEVER, SEVERAL BACK-UP SYSTEMS ARE AVAILABLE TO MITIGATE THE EFFECTS OF SUCH AN EVENT. THE DIRECTIONS FOR USE MANDATES THAT ADEQUATE BACK-UP BE AVAILABLE DURING USE OF THE DEVICE, I.E. THE SECOND DRIVER MODULE FOR UNIVENTRICULAR SUPPORT, OR A COMPLETE DRIVE CONSOLE FOR BIVENTRICULAR SUPPORT. DRIVE PRESSURE FOR THE CONSOLE MAY BE OBTAINED WITH EITHER THE ON-BOARD COMPRESSORS OR HOSPITAL SOURCES OF COMPRESSED AIR AND VACUUM. IN ADDITION, BULBS ARE PROVIDED THAT ENABLE ONE TO HAND-PUMP THE VAD. THE TWO NEW ASSEMBLY OPERATORS HAVE BEEN MADE AWARE OF THE ASSEMBLY ERROR AND ITS CONSEQUENCES IN RELATION TO DEVICE FUNCTION AND THE POTENTIAL EFFECTS ON A PT. A TRAINING SESSION WAS HELD FOR ALL ASSEMBLY OPERATORS, REVIEWING THE PROPER PROCEDURES FOR TIGHTENING FITTINGS AND CHECKING ONE ANOTHER'S WORK. AN ADDITIONAL TRAINING SESSION, CONDUCTED BY THE MFR OR THE TUBING FITTINGS, IS SCHEDULED FOR 10/30/96. QUALITY ASSURANCE PERSONNEL HAVE BEEN INSTRUCTED TO CHECK THE SECURITY OF PRESSURE TUBING IN ITS FITTINGS. THE INCIDENCE OF FAILURES OF THIS TYPE WILL BE MONITORED TO DETERMINE IF ANY FURTHER CORRECTIVE ACTION IS NECESSARY.
THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON MANUALLY MANIPULATED THE DEVICE OF THE TISSUE WITHOUT INCIDENT.
X-TUBE ASSM 18" X 16". X-TUBE BROKEN AT CTR BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION PROCEDURE. THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/22/96- SUPPLEMENT REPORT #1 SUBMIITED TO FDA. ADD'L DATA ENTERED IN D9. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6.
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION PROCEDURE. THE INSTRUMENT WOULD NOT OPEN AFTER FIRING. THE SURGEON MANIPULATED THE JAWS OPEN WITH A KELLEY CLAMP. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/24/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT TO FDA.
NO PT WAS INVOLVED WITH THE REPORTED MALFUNCTION. DURING A TRAINING SESSION IN THE ANIMAL LAB THE VENTRICULAR ASSIST DEVICE (VAD) DUAL DRIVE CONSOLE WAS DISCONNECTED FROM AC POWER WHILE OPERATING AND MOVED TO A DIFFERENT ROOM. THE DRIVE CONSOLE CONTINUED TO OPERATE WITHOUT ANY PROBLEMS UNTIL IT WAS RECONNECTED TO AC POWER, AT WHICH TIME POWER WAS LOST TO THE AIR COMPRESSORS. THE MAIN CIRCUIT BREAKER WAS NOTED TO HAVE TRIPPED, AND AFTER RESETTING IT POWER COULD BE RESTORED TO THE COMPRESSORS. LATER IN THE SAME TRAINING SESSION, WHEN THE DRIVE CONSOLE WAS DISCONNECTED FROM AC POWER THE UNINTERRUPTIBLE POWER SUPPLY (UPS) SYSTEM FAILED TO PROVIDE POWER TO THE AIR COMPRESSORS. HOWEVER, AT THE END OF THE SESSION THE DRIVE CONSOLE OPERATED AS INTENDED WHEN DISCONNECTED FROM AC POWER. IT SHOULD BE NOTED THAT THE ANIMAL LAB FACILITY WAS BRAND NEW, AND THE BLDG SYSTEMS MAY NOT HAVE BEEN COMPLETELY VALIDATED YET.
THE VAD DRIVE CONSOLE WAS EVALUATED BY FIELD SERVICE PERSONNEL ON-SITE. THE AMPERAGE RATING OF THE MAIN DRIVE CONSOLE CIRCUIT BREAKER WAS CONFIRMED TO BE CORRECT. THE "PREVENTIVE MAINTENANCE, CALIBRATION, AND SERVICE REPORT TEST PROCEDURE" WAS PERFORMED, AND THE DRIVE CONSOLE WAS FOUND TO MEET ALL PHYSICAL, MECHANICAL, AND OPERATIONAL SPECIFICATIONS. THE DRIVE CONSOLE WAS CONNECTED AND DISCONNECTED MULTIPLE TIMES FROM SEVERAL DIFFERENT AC ELECTRICAL OUTLETS WITHOUT REPRODUCING THE REPORTED MALFUNCTION. AT THE CONCLUSION OF THE ON-SITE TESTING, THE UNINTERRUPTIBLE POWER SUPPLY (UPS) SYSTEM WAS REPLACED AND BROUGHT BACK TO CO'S FACILITIES FOR FURTHER TESTING AND ANALYSIS. THE UPS SYSTEM WAS TESTED AT CO, REPEATEDLY CONNECTING AND DISCONNECTING THE SYSTEM FROM AC POWER, BUT THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE UPS SYSTEM HAS BEEN SENT TO THE MFR FOR FURTHER EVALUATION. THIS REPORT WILL BE UPDATED, AND ANY CORRECTIVE ACTIONS NOTED, WHEN THE MFR'S EVALUATION HAS BEEN COMPLETED.
THE DISPOSABLE LOADING UNIT WAS USED WITH DISPOSABLE STAPLER DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. THE JAWS WOULD NOT OPEN AFTER THE DEVICE WAS RELOADED. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS STATED NO PT INJURY OCCURRED.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, IT EMPLOYEES, UITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A DIALYSIS TREATMENT A FOUR POSITION LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE RETURNED FOUR-POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT THE CLAMP HOLDER WAS BROKEN. THE TABS ON THE WHITE CLAMP INSERT HOLDER WAS BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. SAFETY ANALYSIS: IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
IT WAS REPORTED THE DEVICE WAS USED DURING A THORACOSCOPY. IT WAS REPORTED THE EZ35B DID NOT FIRE PROPERLY AND WOULD NOT RELEASE FROM TISSUE. THERE WAS NO PT CONSEQUENCE.
H6; CODE 400: FIRING MECHANISM DAMAGED. BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INCIDENT MAY HAVE BEEN CAUSED BY DAMAGE TO THE INTERNAL COMPONENTS. THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND WAS FOUND TO HAVE A DAMAGED CLAMP FIRST LOCKOUT AND WITH BROKEN FIRING TRIGGER TEETH. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE INSTRUMENT IS FIRED BEFORE THE JAWS ARE COMPLETELY CLAMPED, THE INSTRUMENT CAN FIRE THROUGH THE CLAMP FIRST LOCKOUT. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
THE DISPOSABLE LOADING UNIT WAS USED WITH A DISPOSABLE STAPLER DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. THE JAWS WOULD NOT OPEN AFTER THE DEVICE WAS RELOADED. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PRCOEDURE. THE HOSP HAS STATED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING A RIGHT HEMI-COLECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
D5, H4-INFO UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION.
10/02/96 THE SURGEON RESPONDED TO THE NNCL. HE STATED THE INSTRUMENT WOULD NOT FIRE. HE GRABBED THE LUNG TISSUE, PLACED THE INSTRUMENT, AND FIRED. IT DID NOT CUT. HE COULD NOT REMEMBER IF THE DEVICES STAPLED OR NOT. ANOTHER INSTRUMENT WAS OPENED TO COMPLETE THE CASE. KJB
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE TIP OF THE INSTRUMENT BROKE DUE TO EXTREME HEAT FROM DIATHERMY. THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
IT WAS REPORTED THAT WHEN ATTEMPTING A DILATATION PROCEDURE, THE CATHETER BALLOON WOULD NOT INFLATE. THE CATHETER WAS REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT TO COMPLETE THE PROCEDURE. NO PT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.
IT WAS REPORTED A BALLOON RUPTURED ON THE FOURTH INFLATION BEYOND ITS RATED BURST PRESSURE DURING A DILATATION OF AN ARTERIOVENOUS HEMODIALYSIS FISTULA GRAFT AT THE ANASTOMOSIS SITE. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE BALLOON WAS TORN CIRCUMFERTIALLY 4.9CM PROXIMAL TO THE DISTAL TIP. THE DISTAL PORTION OF THE BALLOON MATERIAL WAS BUNCHED UP AT THE DISTAL RO MARKER. THE SHAFT UNDER THE BALLOON WAS FLATTENED AND 9MM OF THE BALLOON MATERIAL WAS MISSING. NUMEROUS CLAMP MARKS WERE NOTED ON THE SHAFT. UPON NOTING A PORTION OF THE BALLOON MATERIAL WAS MISSING, THIS MFR INFORMED THE USER FACILITY OF CO'S FINDINGS. THE USER FACILITY INDICATED THEY WERE NOT AWARE THE MATERIAL HAD DETACHED AND FELT THE BALLOON MATERIAL DID NOT DETACH IN THE PT. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MICH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. IT WAS ALSO INDICATED THIS DEVICE WAS INFLATED BEYOND ITS RECOMMENDED INFLATION PRESSURE AND THAT THE ANASTOMOSIS SITE WAS THE AREA OF STENOSIS AND DILATATION. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. CO DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY. INFLATION IN EXCESS OF RATED BURST PRESSURE MAY CAUSE THE BALLOON TO RUPTURE".
INFO SUPPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION WAS NA AT THE TIME OF SUBMISSION OF THE MEDWATCH REPORT TO THE FDA.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. THE INSTRUMENT DID NOT FIRE PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/22/96- SUPPLEMENT REPORT #1 SUBMITTED TO FDA. ADD'L DATA ENTERED D9. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6.
THE PRODUCT WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, BOTH THE NEEDLE AND SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO INJURY TO THE PT.
10/19/96-MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE CUSTOMER RETURNED TWO SAMPLES TO CO FOR EVALUATION. EXAMINATION OF THE RETURNED UNITS SHOWED THAT ONE HAD A HOLE IN THE SIDE OF THE STOPCOCK PLUG. THIS IS A MOLDING DEFECT. THE MOLDING DEPT HAS BEEN NOTIFIED. THE OTHER UNIT WAS NOT DEFECTIVE. THE LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. CO WAS ABLE TO CONFIRM THIS ISSUE AND TO DETERMINE THE CAUSE. BASED ON THIS INFO, CO BELIEVES THAT THIS ISSUE IS BEING ADDRESSED AND THAT NO ADD'L ACTION IS NECESSARY.
MD APPLIED THE FIXATOR TO TREAT A FRACTURE OF THE DISTAL RADIUS. IT WAS SUBSEQUENTLY NOTED THAT THE DISTAL BALL JOINT WOULD NOT STAY LOCKED. THE FIXATOR WAS REMOVED. THERE WAS NO INJURY TO THE PT.
INVESTIGATION CONDUCTED. DR IS UNSURE OF CAUSE FOR FAILURE. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL, PRE-EXPOSURE, LOADING OF IMPLANT AS POSSIBLE CAUSE FOR FAILURE. THIS FILE IS CLOSED.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED ER320 CLIPS WOULD NOT FORM. A SECOND DEVICE WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. ON 10/03/96 DR CALLED BACK AND CONFIRMED THE INFO AS REPORTED BY THE REP. HE ADDED THE INSTRUMENT SEEMED TO WORK OK, BUT THEN THE NEXT CLIP FIRED WAS LOOSE ON THE STRUCTURE. HE ALSO REPORTED PROBLEMS WITH SPITTING WITH THIS INSTRUMENT. THE SPIT CLIPS WERE RETRIEVED. ANOTHER INSTRUMENT WAS OPENED TO COMPLETE THE CASE.
H6; CODE 400: YIELDED JAWS. RESULTS OF EVAL: CONCLUSION-BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS-IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. DR CITED POST SURGICAL (PRE-EXPOSURE) LOADING OF THE IMPLANT AND MICROMOVEMENT OF THE IMPLANT FROM THE TEMPORARY PROSTHESIS AS CAUSES FOR FAILURE.
PT STATED WHEN TANK WAS TURNED ON THAT A PIECE FROM THE REGULATOR FLEW ACROSS THE ROOM. PT'S WIFE STATED THAT A NEW WASHER WAS GIVEN TO THEM BY THE DEALER, BUT HER HUSBAND ALSO APPLIED A SECOND WASHER (PLASTIC WASHER). REGULATOR HAD TWO WASHERS. PT DID NOT FOLLOW THE DIRECTIONS FOR USE LABELS".
INITIAL INSPECTION: YOKE ASSEMBLY DISCONNECTED. 1. THREAD 9/16 - 24 UNF STRIPPED ON BOTH NIPPLE EXTENSION AND ON NUT. 2. ANODIZE FINISH STRIPPED FROM BOTH YOKE PINS, ONE MORE THAN THE OTHER AND SOME METAL WAS STRIPPED OFF ONE PIN. 3. CUSTOMER REPORTED USING TWO WASHER/GASKETS, ONE STANDARD CPI STYLE AND THE SECOND A "PLASTIC" WASHER (MISSING). EVALUATION: 1. BECAUSE CUSTOMER USED TWO WASHER/GASKETS THE REGULATOR COULD NOT BE INSTALLED ON THE VALVE IN THE CORRECT POSITION, MATCHING PINS OF REGULATORS TO HOLES IN VALVE. 2. IN ORDER TO STOP LEAKING, IT IS DETERMINED THAT CUSTOMER TIGHTENED THE YOKE HARDER AND HARDER, CAUSING THE PINS TO NOT SIT PROPERLY. NOTE, PINS ARE IN THEIR CORRECT ORIENTATION , NOT BENT OR OTHERWISE DEFLECTED. 3. REGULATOR WAS NOT IN PERPENDICULAR POSITION TO VALVE, BUT DID HAVE AN INADEQUATE SEAL DUE TO DOUBLE WASHER INSTALLATION. THE STRAIGHT LINE ORIENTATION OF PRESSURE AND THREAD CENTER-LINE WAS BROKEN. RESULTANT FORCE OF THE PRESSURE AND OVER-TIGHTENING CAUSED THE THREADS ON THE EXTENSION TO STRIP AND THE RETAINING NUT TO BEND. IT IS ESTIMATED THE FORCE ON THE THREADS WAS IN EXCESS OF 10,000 PSI. 4. THE REGULATOR WAS REASSEMBLED AND FOUND TO BE IN WORKING ORDER AND TO MATCH ORIGINAL SPECIFICATIONS AS TO FLOW RATE AND PRESSURE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. DR CITES CAUSE FOR FAILURE DUE TO INSUFFICIENT BONE QUALITY. THIS FILE IS CLOSED.
IT WAS REPORTED THE DEVICE WAS USED DURING A DIAGNOSTIC LAP PROCEDURE. IT WAS REPORTED THE 355S WOULD NOT ARM. THE ARMING MECHANISM WOULD NOT LOCK. A SECOND 355S WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
A1,2,3,4; B6,7; D10 INFO UNAVAILABLE. BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS OBSERVED THAT THE INSTRUMENT ARMED INTERMITTENTLY. THE ENDCAP WAS OBSERVED TO HAVE BEEN WELDED EXCESSIVELY TO THE OBTURATOR HANDLE WHICH MAY HAVE CAUSED THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN A EFFORT TO CONTINOUSLY IMPROVE ITS PRODUCTS. APPROPRIATE ENGINEERING AND MANUFACTURING PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.
THE PART THAT HAS THE CLAMP ON IT, NEXT TO THE CAP USED FOR REINFUSION, COMES APART WHEN TIPPED UPSIDE DOWN FOR REINFUSION AND THE BLOOD LEAKS OUT.
INVESTIGATION CONDUCTED. DR CITES  INSUFFICIENT BONE QUALITY AND QUANTITY AS CAUSE FOR FAILURE DUE TO "IMPROPER" BONE GRAFT MATERIAL AND NOT USING ANOTHER CO'S GRAFT. PT IS ONLY I5 YRS OLD. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. PT USES TOBACCO. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL (HEALING ABUTMENT) LOADING OF THE IMPLANT. THIS FILE IS CLOSED.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TRUE BROKE AT THE CROSS BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE POSSIBLY DUE TO DIMINISHED ORAL HYGIENE. IMPLANT WAS SOLID PRIOR TO CROWN PLACEMENT THEN DEVELOPED AN INFECTION. THIS FILE IS CLOSED.
10/19/96- MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
51 DAYS S/P INSERTION OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) THE PT (PT) WAS SITTING UP IN A CHAIR & MADE A REACHING MOTION TO HER RIGHT AND DEVELOPED A SUDDEN AND BRIEF EPISODE OF HYPERTENSION, CYANOSIS & LOSS OF CONSCIOUSNESS DUE TO SPONTANEOUS FAILURE OR THE TOP MODULE OF THE LVAD. NO ALARM SOUNDED. THE PT WAS THEN PLACED SUPINE IN BED AND THE PUMP DID NOT RESUME FUNCTIONING. FOUR ATTEMPTS WERE MADE TO ACTIVATE THE BOTTOM MODULE BEFORE THE PUMP RESUMED FUNCTIONING. PT WAS GIVEN SUPPLEMENTAL OXYGEN AND RECEIVED A FEW SMALL VOLUME CHEST COMPRESSIONS UNTIL THE PUMP RESUMED FUNCTONING. PT RETURNED TO BASELINE WITHIN A FEW MINUTES WITHOUT ANY PERMANENT SEQUELAE. PT WAS SWITCHED TO A DIFFERENT CONSOLE.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY IS THE CAUSE FOR FAILURE. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES THAT POST SURGICAL (HEALING ABUTMENT) LOADING OF THE IMPLANT AS POSSIBLE CAUSE FOR FAILURE. THIS FILE CLOSED.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CTR HOLE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. DR DOES NOT CITE CAUSE FOR FAILURE. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES THE CAUSE FOR FAILURE IS DUE TO INSUFFICIENT BONE QUALITY. THIS FILE IS CLOSED.
THE PRODUCT WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, BOTH THE NEEDLE AND SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO INJUURY TO THE PT.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT OF THE IMPLANT FROM THE PROSTHESIS AND INSUFFICIENT BONE QUANTITY AS CAUSES FOR FAILURE. THIS FILE IS CLOSED.
THE PT WAS INITIALLY SWITCHED TO THE BACK-UP DRIVE MODULE AND THE VENTRICULAR ASSIST DEVICE (VAD) RESUMED PUMPING. ALTHOUGH THE INITIAL REPORTER CLAIMS THAT NO ALARMS SOUNDED FROM THE DRIVER AT THE TIME OF THE INCIDENT, THE HOSPITAL CIRCULATORY SUPPORT NURSE SPECIALIST WHO WAS TROUBLE-SHOOTING THE SITUATION HAD TO INSTRUCT THE ON-DUTY NURSE TO SILENCE THE DRIVER ALARMS IN ORDER TO HEAR EACH OTHER ON THE TELEPHONE. THE PT WAS SWITCHED OVER TO A BACK-UP DRIVE CONSOLE AND A FAILURE INVESTIGATION OF THE ORIGINAL DRIVE CONSOLE WAS BEGUN BY THE HOSPITAL CIRCULATORY SUPPORT TEAM, BUT THEY WERE UNABLE TO REPRODUCE THE FAILURE. DRIVE MODULE PUMPING AND ALARM FUNCTIONS APPEARED NORMAL. CO FIELD SERVICE PERSONNEL ARRIVED ON-SITE FOUR DAYS LATER TO EVALUATE THE DRIVE CONSOLE. ALL CIRCUIT BOARDS WERE INSPECTED FOR EVIDENCE OF IMPROPER SEATING, BURNS, LOOSE INTEGRATED CIRCUITS, OR BENT PINS ON INTEGRATED CIRCUITS. THE "PREVENTIVE MAINTENANCE, CALIBRATION, AND SERVICE REPORT TEST PROCEDURE" WAS PERFORMED, AND THE DRIVE CONSOLE WAS FOUND TO CONFORM WITH ALL PHYSICAL, MECHANICAL, AND OPERATIONAL SPECIFICATIONS. THE DRIVE CONSOLE WITH THE REPORTED MALFUNCTION WAS THEN USED FOR THREE DAYS FOR A PREVIOUSLY SCHEDULED IN-SERVICE TRAINING SESSION. NURSING AND PERFUSION STAFF WERE TRAINED IN THE OPERATION OF THE DRIVE CONSOLE. THE BIOMEDICAL ENGINEERING STAFF WAS TRAINED ON HOW TO PERFORM THE "PREVENTIVE MAINTENANCE, CALIBRATION, AND SERVICE REPORT TEST PROCEDURE," PERFORMING THE COMPLETE TEST PROCEDURE AT LEAST TWO TIMES WITHOUT NOTING ANY MALFUNCTIONS OR FAILURES TO MEET SPECIFICATIONS. IN SPITE OF TESTING AND USE OVER A PERIOD OF THREE DAYS, THE REPORTED FAILURE COULD NOT BE REPRODUCED, NOR WAS ANY ASPECT OF THE DRIVE CONSOLE FOUND TO BE OUT OF SPECIFICATIONS. THEREFORE, THE CAUSE OF THE REPORTED INCIDENT REMAINS UNKNOWN. CORRECTIVE ACTION: SINCE THE CAUSE OF THE REPORTED INCIDENT REMAINS UNKNOWN AT THIS TIME, NO CORRECTIVE ACTION IS WARRANTED. INCIDENTS OF THIS TYPE WILL BE MONITORED AND TRACKED IN ORDER TO ASCERTAIN ANY COMMON FACTORS WHICH MIGHT IDENTIFY A CAUSE.
INVESTIGATION CONDUCTED. DR STATES THAT CAUSE FOR FAILURE IS UNKNOWN. THIS FILE IS CLOSED.
12/16/96-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INVESTIGATION CONDUCTED. DR CITES THAT HE DOES NOT KNOW CAUSE FOR FAILURE. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR DOES NOT KNOW REASON FOR FAILURE. THIS FILE IS CLOSED.
PT UNDERWENT CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT OF RIGHT EYE. DURING PROCEDURE PHACO HANDPIECE MALFUNCTIONED AND A BACK UP HANDPIECE WAS OPENED FROM STERILE PACKAGING. DURING THE PROCEDURE, THE PHYSICIAN NOTED RED AND GREEN SPECKS ADHERING TO THE PT'S IRIS. THE SPECKS COULD NOT BE COMPLETELEY IRRIGATED FROM THE EYE. PHACO HANDPIECE IMPOUNDED AND RETURNED TO MFR FOR EVALUATION.
THIS DEVICE FAILED THE EXCURSION TEST WHEN OPERATED AT 100% POWER. A FILTER TEST WAS PERFORMED AND THE HANDPIECE PASSED. THE CUSTOMER COMPLAINT COULD NOT BE DUPLICATED.
12/17/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. RETURNED FOR EVALUATION WAS A PARTIAL STRAND OF SUTURE. AS ONLY A PARTIAL STRAND WAS RETURNED, AN ADEQUATE EVALUATION OF THE REPORTED CONDITION COULD NOT BE PERFORMED, AND A RELIABLE CONCLUSION AS TO THE CAUSE OF THE CONDITION REPORTED COULD NOT BE MADE.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE WHILE RIDING ALONG BROKE AT BOLT HOLE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABEL EVENT.
INVESTIGATION CONDUCTED. DR CITES SURGICAL TRAUMA, IMPINGENCE ON TRIGEMINAL NERVE, AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS SCISSORED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/19/96- SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
A1,2,3,4;B6,7;D10: INFO AVAILABLE. D5,6;H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR EVAL. H6: INFO UNAVAILABLE AT THIS TIME.
ON 9/27/96 SURGEON DIRECTLY REPORTED THE EVENT TO EES. HE STATED SOURCE THE OR MAY BE ABLE TO PROVIDE ADDITIONAL INFORMATION AND/OR CONFIRM AVAILABILITY OF THE INTRUMENT. TSB
X-TUBE ASSEM 19" X 18". DEALER CLAIMS X-TUBE BROKE AT THE BOLT HOLE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBURTED TO THE REPORTABLE EVENT.
IT WAS REPORTED THAT WHEN ATTEMPTING TO DILATE INSIDE A PREVIOUSLY PLACED STENT, THE DISTAL TIP AND BALLOON OF THE CATHETER BROKE OFF INDWELLING THE PATIENT. THE CATHETER & SHEATH WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITH IMPROVED FLOW RATE NOTED. THE LOCATION AND REMOVAL OF THE INDWELLING PIECE HAS NOT BEEN REPORTED. NO FURTHER COMPLICATIONS REPORTED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE'S FIRING BUTTON WOULD NOT ENGAGE. THE DEVICE WAS FROM LAP CHOLE KIT FTCO6. THE DEVICE WAS NOT USED IN THE PROCEDURE. 9/27/96-THE REP REPORTED THE SURGEON USED A 5MM TROCAR TO COMPLETE THE CASE.
INVESTIGATION CONDUCTED. DR CITES INFECTION AND INSUFFICENT BONE QUALITY AS CAUSE FOR FAILURE POSSIBLY DUE TO DIMINISHED ORAL HYGIENE. THIS FILE IS CLOSED.
A SURGICAL PT WAS PREPPED, THE SHEET WAS PLACED ON THE OPERATIVE SITE AND UNFOLDED, WHEN THE SHEET WAS UNFOLDED A SILVERFISH RAN OUT OF THE FOLD. THE PT WAS REPREPPED AND REDRAPED. SURGERY WAS DELAYED 30 MINUTES.
DATE SENT TO FDA: 10/25/96. B2-SURGERY DELAYED 30 MINUTES. B4,F8,G4-MFR'S ALERT DATE.
X-TUBE ASSEMBLY 18" X 16. DEALER CLAIMS X-TUBE BROKE AT WELD LOCATION.
HIGH STRESS FACTOR AT HEAT AFFECTED ZONE.
X-TUBE ASSEMBLY 18" X 17". DEALER CLAIMS X-TUBE BROKE AT LEFT SEAT RAIL.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
X-TUBE ASSEMBLY 17" X 18". DEALER CLIMS X-TUBE BROKE AT THE CTR BOLT.
X-TUBE ASSM 18" X 16" DEALER CLAIMS: BROKEN AT THE CTR BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THIS FDA THAT THE DEVICE CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CUASED OR CONTRIBUTED TO THE REPORTABLE EVENT.
UNABLE TO SUCTION PT, TUBE WAS KINKED. UNKINKED TUBE AND WAS ABLE TO SUCTION PT. ONE HOUR 15 MINUTES LATER, THE TUBE WAS KINKED AGAIN. EXTUBATED PT. PT STABLE. AFTER A PERIOD OF TIME, THE ENDOTRACHEAL TUBE STRAIGHTENED ITSELF.
THE DEVICE WAS APPLIED DURING A RIGHT LOWER LOBECTOMY PROCEDURE. REPORTEDLY, THE JAWS WERE DIFFICULT TO OPEN. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
10/25/96-MEDWATCH REPORT NOT RECEIVED BY MFR,. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
IT WAS NOT POSSIBLE TO PREP THE DILATATION CATHETER BECAUSE THE HUB WAS DETACHED. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. DURING PROCESSING OF THS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSP OR DISTRIBUTER. THE RESULTS OF ANALYSIS CONCLUDED THAT TWO COMPONENTS (THE HYPOTUBE JACKET AND ADPATION CUP) WERE NOT SUFFICIENTLY BONDED TOGETHER. THE INCOMPLETE BOND WAS RELATED TO THE HEAT INDUCTION PROCESS USED TO COMPLETE THE BOND IN THIS LOCATION. PREVIOUS TO THIS INCIDENT A FILING WAS SUBMITTED TO THE FDA AND APPROVED (12/28/95) WHICH ADDRESSES THIS ISSUE. THESE CHANGES HAVE BEEN IMPLEMENTED BY MFG,. NO OTHER REMEDIAL ACTION HAS BEEN TAKEN. SINCE THE BEGINNING OF 1996 UNITS HAVE BEEN SHIPPED WITH THIS PROCESS IMPROVEMENT. THE DEVICE IN QUESTION WAS MADE PREVIOUS TO THESE CHANGES. A REVIEW OF THE COMPLAINT TREND DATA FOR THIS TYPE OF COMPLAINT SHOWED THAT ITS SEVERITY IS EXTREMELY LOW. IT IS VERY UNLIKELY THAT A HUB SEPARATION COULD CAUSE OR CONTRIBUTE TO A SERIOUS PT OUTCOME, ESPECIALLY IN ATRIAL (RX) DEVICE. QUALITY ASSURANCE CONTINUES TO MONITOR THE DEVICE FOR THIS TYPE OF COMPLAINT. THE COMPLAINT RATE HAS SIGNIFICANTLY DECREASED SINCE THE PROCESS MODIFICATION WAS IMPLEMENTED. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPT.
THE DISPOSABLE LOADING UNIT WAS USED WITH DISPOSABLE STAPLER DURING AN OOPHERECTOMY PROCEDURE. REPORTEDLY, BLEEDING WAS OBSERVED FROM THE STAPLE LINE. THE SURGEON CAUTERIZED THE SITE AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
12/17/96 - SUPPLEMENT REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
DURING HYSTERECTOMY PROCEDURE THE 30 DEGREE RESECTOSCOPE CAME APART IN THE PT. THIS REQUIRED USE OF ANOTHER SCOPE TO RETRIEVE THE PARTS FROM THE PT.
DURING ORBITED ROTATION OF THE GAMMA CAMERA, THE COLLIMATOR FELL OFF THE DETECTOR. NONE OF THE FOUR COLLIMATOR HOLD-DOWN SCREWS HAD BEEN PROPERLY ENGAGED BY THE OPERATOR, AND THE SENSOR TO ALERT THE USER THAT THE COLLIMATOR WASN'T SECURE MALFUNCTIONED. THE COLLIMATOR FELL TO THE FLOOR. NO ONE WAS INJURED.
AFTER BEING INFORMED OF THIS INCIDENT ON 9/20/96, CO SVC EXAMINED THE SYSTEM AND DISCOVERED THE DEVICE MALFUNCTION. THE SENSOR WAS DETERMINED TO BE FUNCTIONING PROPERLY, BUT A WIRE TO THE ALARM BUZZER WAS LOOSE. THEREFORE, THE OPERATOR ALARM DID NOT SOUND. THIS SYSTEM HAS BEEN IN OPERATION FOR 12 YEARS AND THIS TYPE OF FAILURE HAS NOT OCCURRED PREVIOUSLY.
NO APPARENT PRODUCT ANOMALIES CONTRIBUTING TO REPORTED PROBLEM. OBJECTIVE CELL BOND LINE INTACT. INSUFFICIENT INFO TO DETERMINE PRECISE CAUSE OF PROBLEM. EVIDENCE OF INCIPIENT FAILURE (FOGGING, DEGRADED OPTICS) EITHER NOT DETECTED BY USER OR NOT CORRECTED BY RETURNING INSTRUMENT FOR EVALUATION.
DURING 7/96, A PT SERUM SAMPLE GAVE A POSITIVE RESULT USING THE HCG KIT. A QUANTITATIVE TEST WAS PERFORMED FOR A NEGATIVE RESULT EQUAL TO 7.0. THE PT'S HUSBAND HAS HAD A VASECTOMY. THE SAMPLE WAS REPEAT TESTED THE SAME DAY AND IT WAS AGAIN POSITIVE. THE PT CAME BACK FOR TESTING AND A SERUM SAMPLE ON A NEW LOT GAVE A NEGATIVE RESULT. THE ACCOUNT DID NOT HAVE ANY SAMPLES AVAILABLE AND DID NOT HAVE ANY FURTHER INFO. THE PT HAD COME IN FOR A PHYSICIAL AS PART OF RESEARCH PROTOCOL TESTING FOR A STUDY SHE WAS GOIND TO BE PARTICIPATING IN THROUGH THE ARMY.
EVAL COMPLETE-FINAL REPORT. FEMALE PT HAD BEEN ON DURG "BIPHALIC." NO INFO AVAILABLE ON DURG "BIPHALIC". ACCOUNT STATED THAT "THERE WAS RESIDUAL HCG IN HER SYSTEM". NO MALFUNCTION HAD OCCURRED.
ON 9/4/96, THE ACCOUNT OBTAINED AN ABERRANT BHCG RESULT OF 1.0 MIU/ML ON A PT SAMPLE, WHICH WAS REPORTED TO THE DR. A SECOND SPECIMEN WAS COLLECTED TWO WEEKS LATER ON 9/18/96, AND A RESULT OF 8000 MIU/ML WAS OBTAINED. THE ACCOUNT THEN DEFROSTED THE INITIAL SAMPLE, MIXED, SPUN AND RERAN IT. A RESULT OF 126.35 MIU/ML WAS OBTAINED. NO MEDICAL INTERVENTION OCCURRED AS THE PHYSICIAN BELIEVED TO PT WAS PREGNANT AND THEREFORE TOOK A SECOND SAMPLE TWO WEEKS LATER.
INVESTIGATION SYMMARY: THE EVENT REP. IS NOT ADDRESSED IN THE DEVICE LABELING. A MALFUNCTION DID OCCUR. THIS REPORTABLE MDR EVENT WAS INVESTIGATED AS PART OF AN ONGOING STUDY OF THE AXSYM SYSTEM BY CO INTO THE CAUSATIVE REASON FOR MALFUNCTIONS. RESULTS OF THE INVESTIGATION YIELDED A NUMBER OF SYSTEM ENHANCEMENTS IMPLEMENTED ON CUSTOMER UNITS. IMPROVEMENTS INCLUDED AXSYM SYSTEM SOFTWARE VERSION 3.0 WITH ENHANCED ALGORITHM FOR FLUID DETECTION, NEW BUFFER TUBING AND SEAL FITTINGS WHICH REDUCED BUBBLES FORMING IN TUBING LINES, MODIFICATIONS TO THE LIQUID LEVEL SENSE BOARD TO DECREASE SENSITIVITY OF THE INSTRUMENT TO ELECTROSTATIC DISHCARGE, AND PACKAGING MODIFICATIONS FOR ADDED PROTECTION TO PROBES. IN ADDITION, CO HAS EMPHASIZED TO CO'S CUSTOMERS THAT CORRECT OPERATING PROCEDURES MUST BE FOLLOWED TO ENSURE OPTIMAL PERFORMANCE OF THE AXSYM SYSTEM. AREAS THAT WERE EMPHASIZED INCLUDED PROBE CRASH RECOVERY PROCEDURE, RECOMMENDED TUBE SIZES AND TYPES, OPENING REAGENT BOTTLE 4, PROPER LOADING/UNLOADING OF REAGENT PACKS, AND ENSURING PROPER SAMPLE AND REAGENT HANDLING. THIS IS THE FINAL REPORT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT LOAD PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/4/1996-SUBMISSION OF SUPPLEMENTAL REPORT TO FDA. ADDITONAL INFO SUBMITTED FOR D7, D8 AND D9. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA SUBMITTED FOR D10 AND E1 (ADDRESS AND PHONE NUMBER).
UNABLE TO SUCTION PT, TUBE WAS KINKED. UNKINKED TUBE AND WAS ABLE TO SUCTION PT. ONE HOUR 15 MINUTES LATER, THE TUBE WAS KINKED AGAIN. EXUBATED PT. PT STABLE. AFTER A PERIOD OF TIME, THE ENDOTRACHEAL TUBE STRAIGHTENED ITSELF.
EVALUATION: DEVICE WAS EVALUATED. CONFIRMED "KINK" IN TUBE FROM PHOTOGRAPHIC IMAGES FROM FACILITY. HOWEVER, TUBE WAS STRAIGHTENED WHEN RECEIVED. FROM PHOTOGRAPHS THE KINK APPEARS TO BE VERY CLOSE TO THE INLET OF THE PILOT VALVE (INFLATION LUMEN). UNABLE TO DETERMINE EXACT CAUSE OF KINK AS SEEN BY THE USER FACILITY. IN ADDITION, THE KINK INDICATED BY THE USER FACILITY SUGGESTS THAT THE MALFUNCTION OCCURRED AS A RESULT OF USER/DEVICE TECHNIQUE OR OTHER ENVIROMENTAL CONTRIBUTING FACTORS. COULD NOT DUPLICATE THIS MALFUNCTION UNDER "NORMAL" SITUATION OF FIELD PERFORMANCE. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? N. IS THE EVENT SEVERITY ADDRESS IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? N. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT CO DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT CO DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
THE PT WAS BEING SEEN FOR INITIAL EVALUATION. TWO ELECTRODES (CHANEL 1) WERE PLACED ON HAMSTRING, AND TWO ELECTRODES (CHANNEL 2) WERE PLACED ON QUADS. STIMULATOR WAS TURNED ON AND INTENSITY WAS INCREASED TO 32MA ON CHANNEL 1, AND TO 60MA ON CHANNEL 2. SUDDENLY, THE STIMULATOR BEGAN TO OPERATE; CHANNEL 1 CAME ON AND THEN AS CHANNEL 2 CAME ON, PT YELLED "OUCH" AND EXPERIENCED A STRONG QUAD CONTRACTION WHICH WAS ALSO OBSERVED. (PREVIOUSLY, THE PT COULD NOT PERCEIVE ANY SENSATION ON CHANNEL 2). THE STIMULATOR WAS THEN SHUT OFF AND REMOVED FROM SVC, AND RETURNED TO THE MFR.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE AND COMPONENTS DISENGAGED INSIDE THE PT'S CAVITY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
10/25/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. THE EVALUATION OF THE DEVICE REVEALED CARTRIDGE WHICH INDICATES THE JAWS WERE CLOSED WITH THE CARTRIDGE NOT FULLY SEATED. THIS CONDITION HAS BEEN ATTRIBUTED TO THE USER OVERRIDING THE SAFETY INTERLOCK FEATURE.
BALLOON WAS DISLODGED FROM SHAFT DURING ANGIOPLASTY OF STENT PLACEMENT WITHIN AN A-V GRAFT. ATTEMPTS TO RETRIEVE BALLOON WERE UNSUCCESSFUL THEREFORE SURGEON WAS CALLED IN ON THE CASE.
PT HAD BURNS ON HER CHEST THAT CORRESPOND TO THE THREE SCREW HEADS ON THE END OF THE MAMMOGRAPHY BUCKY. PT WAS HAVING A NEEDLE PLACEMENT MAMMOGRAPHY. FOUND 15VDC WIRE PINCHED AND SHORTED TO FRAME OF BUCKY.
ON 8/15/96 A DONOR EXPERIENCED AN ACD REACTION DURING A PLATELETPHERESIS BECAUSE THE PUMP HANDLE HAD BEEN LEFT OPEN. ON 10/23/96 UPON REVIEW OF INFO RECEIVED AS OF 10/23 IT WAS DEEMED THAT THIS TYPE OF EVENT IS REPORTABLE EVENT AND AT THIS POINT ADD'L INFO WAS REQUESTED  FROM THE CUSTOMER. THE CUSTOMER WAS UNABLE TO REMEMBER SPECIFIC EVENT INFO SUCH AS THE EVENT DATE. THE NURSE THINKS THAT IT OCCURRED APPROX ON 10/1/96 BUT IS NOT SURE. THE NURSES HAVE ALWAYS REGULATED PT'S ACD DELIVERY CAREFULY BECAUSE OF PT'S ACD SENSITIVITY. AT THE TIME WHEN THE INCIDENT OCCURRED THE DONOR RECEIVED APPROX 200-300 ML OF ACD IN 15 MINUTES. SYMPTOMS WERE TINGLING AND NUMBNESS. THE DONOR RECUPERATED OKAY AND WAS RELEASED IN GOOD CONDITION.
EACH EVENT PROBLEM CODES (PT/DEVICE CODE) ADDRESSED IN LABELING? YES. MFR DESCRIBED IN THE DIRECTION FOR USE OF THE DISPOSABLE KIT, THE PROPER TECHNIQUE FOR PLACING THE ACD PUMP TUBING IN THE ACD PUMP AND CLOSNG THE ACD PUMP HANDLE OF THE ACCESS MANAGEMENT SYSTEM. UNDER THE ADVERSE EFFECTS: A STATEMENT APPEARS ADDRESSING THE EFFECTS THAT A VERY RAPID RATE OR INFUSION OF ANTICOAGULANT HAS ON THE DONOR. USER FACILITY. CO'S EDUCATONS DEPT RETRAINED THE CUSTOMER ON THE PROPER PLACEMENT OF ACD TUBING AND CLOSING THE AMS PUMP HANDLE. CONTINUATION FROM SECTION H DEVICE MFRS ONLY: EVALUATION CODE CONCLUSION : 70 (DEVICE DISCARDED, UNABLE TO FOLLOW UP).
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN AN AV GRAFT, THE CATHETER BALLOON RUPTURED AT 20 ATM AND UPON CATHETER REMOVAL, THE BALLOON WAS MISSING. UNSUCCESSFUL ATTEMPT WAS MADE USING A SNARE TO RETRIEVE THE INDWELLING PIECE. THE PT WAS SENT TO SURGERY FOR REMOVAL OF THE CATHETER BALLOON FROM THE PT. NO FURTHER COMPLICATIONS WERE REPORTED.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR. DISCREPANCY IN B2 IN USER REPORT FOR THE ABOVE REASON. H6, METHOD CODE 86, USED AS SAMPLE WAS DISCARDED BY THE USER WHICH PREVENTED AN EVAL. CODE 68 USED AS THE PRODUCT WAS BEING USED OUTSIDE ITS LABELED INDICATIONS.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON ADJUSTED THE INSTRUMENT AND IT THEN FIRED FINE.
DURING AN EXTRACAPSULAR CATARACT EXTRACTION OF THE LEFT EYE WITH AN INTRAOCULAR LENS IMPLANTATION, A BURN OCCURRED TO THE LEFT EYE WHILE USING A PHACOEMULSIFIER HANDPIECE, EVENTUALLY CAUSING A TEMPORARY ASTIGMATISM.
THE DEFIBRILLATOR WAS USED DURING A CARDIAC ARREST AND DID NOT DISCHARGE UPON DEPRESSING THE CHARGE RELEASE BUTTONS IN THE PADDLES. THE MACHINE WAS DISCONNECTED IMMEDIATELY AND ANOTHER ONE REPLACED IT. IT IS UNKNOWN WHAT CAUSED THE MALFUNCTION TO OCCUR. THE PT WAS SUCCESSFULLY DEFIBRILATED AND TRANSFERRED TO THE CORONARY CRITICAL CARE UNIT AND EXPIRED FOUR YRS LATER.
IN AN EVALUTION OF THE DEVICE BY THE LOCAL CO SERVICE REP, A COMPLETE FUNCTIONAL TEST WAS PERFORMED AND PROPER OPERATION WAS OBSERVED. THE UNIT WAS RETURNED TO THE FACILITY FOR USE. F10: CODE #1762-LABELED. CODE #1211-LABELED.
EXPLANTED RUPTURED RIGHT BREAST IMPLANT.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR. THE FOLLOWING DISCREPANCIES EXIST IN THE USER'S REPORT AND HAVE BEEN CORRECTED ON THIS REPORT: B1,B2,D1,D2,D3, D9 & F14. THE USE OF "86" IN H6 WAS DUE TO THE SAMPLE BEING RETAINED AT THE FACILITY AND O METHOD FOR EVALUATING THE PRODUCT WAS POSSIBLE.
CERVICAL DISC DISPLACEMENT WITH REMOVAL OF IMPLANTED DEVICES.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO "INFLAMMATION WITH INFECTION AROUND PUMP". AS REPORTED TO CO, "THERE WAS NO PROBLEM WITH DEVICE FUNCTION, PT HAS EXTENSIVE PREVIOUS IMPLANT HISTORY".
ON 10/19/96 DURING A PLATELETPHERESIS PROCEDURE AT THE ONSET OF THE PROCEDURE THE DONOR COMPLAINED OF TINGLING AND NUMBNESS OF THE LIPS AND MOUTH. THE WHOLE BLOOD FLOW RATE WAS SAID TO HAVE BEEN SLOWED DOWN AND THE PROCEDURE WAS CONTINUED. 7-8 MINUTES AFTER THE FIRST COMPLAINT THE DONOR COMPLAINED OF DIFFICULTY BREATHING, TIGHTNESS OF CHEST AND THROAT AND THAT SHE COULD NOT FEEL HER FEET. AT THIS POINT THE NURSE NOTICED THAT THE ACD PUMP HANDLE HAD BEEN LEFT OPEN AND THE DONOR HAD RECEIVED 275 ML OF ACD IN 22 MINUTES. THE ACCESS MGMT SYSTEM READ OUT SHOWED THAT 108 ML OF ACD HAD BEEN USED. THE MACHINE WAS PUT ON HALT/IRRIGATE. PROCEDURE DISCONTINUED. TUMS WERE ADMINISTERED TO THE DONOR. THE DONOR RECUPERATED FULLY AND RELEASED IN GOOD CONDITION. THE BASELINE BLOOD PRESSURE WAS 110/70 THE PULSE WAS 84. IMMEDIATELY AFTER THE INCIDENT THE BLOOD PRESSURE WAS 110/80 (PULSE NOT INDICATED). THIS IS A FEMALE, 45 YEARS OLD 125 POUNDS 5 FEET 6 INCHES TALL. DONOR HAS DONATED BEFORE AND IT WAS SAID TO HAVE SHOWN TO BE SUSCEPTIBLE TO ACD IN PREVIOUS DONATIONS.
EACH EVENT PROBLEM CODES (PT/DEVICE CODE) ADDRESSED IN LABELING? YES. MFR DESCRIBED IN THE DIRECTION FOR USE OF THE DISPOSABLE KIT, THE PROPER TECHNIQUE FOR PLACING THE ACD PUMP TUBING IN THE ACD PUMP AND CLOSING THE ACD PUMP HANDLE OF THE ACCESS MGMT SYSTEM. UNDER THE ADVERSE EFFECTS: A STATEMENT APPEARS ADDRESSING THE EFFECTS THAT A VERY RAPID RATE OR INFUSION OF ANTICOAGULANT HAS ON THE DONOR. USER FACILITY. CONTINUATION FROM SECTION H: DEVICE MFRS ONLY: EVALUATION CODE CONCLUSION: 70 (DEVICE DISCARDED, UNABLE TO FOLLOW UP).
OPEN CAPSULECTOMY BILATERALLY EXCHANGE LEFT IMPLANT WITH SALINE. ADD'L EXPLANT DATE 1990.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CTR HOLE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE PERCUTANEOUS TRACHEOSTOMY TUBE WAS IN USE FOR 3 DAYS WHEN THE PT'S PEEK INSPIRATORY PRESSURE AND PCO2 LEVELS WERE NOTED AS BEING TOO HIGH. THE PT ALSO HAD MARKEDLY DECREASED BREATH SOUNDS. VIEWING THROUGH A BRONCHOSCOPE, THE CLINICIAN NOTED AN OBSTRUCTION AT THE TIP OF THE TRACHEOSTOMY TUBE WHICH WAS THOUGHT TO BE THE LEFT LATERAL TRACHEAL MUCOSA. THE TUBE WAS REMOVED AND REPLACED WITH A DIFFERENT STYLE TUBE AND THE PT'S PRESSURE AND PCO2 LEVELS RETURNED TO NORMAL.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FOOD AND DRUG ADMINISTRATION BY CO, INC. PURSUANT TO 21 CFR PART 803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AND ADMISSION BY THE CO THAT A CO DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF AN CAUSAL CONNECTION BETWEEN A CO DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. NO ENTRY THROUGHOUT THE FORM CO HAS CONTACTED THE USER FACILITY ON SEVERAL OCCASIONS AND THEY ARE STILL GATHERING INFO ON THIS EVENT. H.6 (METHOD) CODE 86 OTHER: VISIT TO USER FACILITY BY CO PERSONNEL ON 10/30/96. H.6. (CONCLUSION) CODE 62: CO HAS CONCLUDED THAT CLINICIAN CHOICE OF TUBE SIZE MAY BE A CONTRIBUTING FACTOR TO THIS EVENT.
PT ADMITTED FOR COSMETIC SURGERY (FACELIFT, LASER ABLATION). NURSE WAS CALLED INTO PT'S ROOM POST-OP, AND WAS NOTIFIED OF BLUE DISCOLORATION ON R SIDE OF MOUTH, R SIDE OF CHIN. THE ICEPACK APPARENTLY SLID DOWN AROUND THE PT'S MOUTH, AND BACITRACIN OINTMENT DISSOLVED THE INK ON THE ICEPACK LABEL. THE INK SOAKED INTO PT'S SKIN, CAUSING BLUE DISCOLORATION. AREA OF DISCOLORATION WAS SCRUBBED W/STERILE GAUZE AND STERILE 3% NACL UNTIL DISCOLORATION FADED OUT. SLIGHT BLUE STREAK STILL NOTED AT (R) CORNER OF MOUTH. PT D/C HOME SAME DAY.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR'S OFFICE.
DILATATION BALLOON BROKE BEFORE WHILE PHYSICIAN WAS PERFORMING ANGIOPLASTY ON AN ART/VIN. SHUNT BROKEN FRAGMENT OF BALLOON HAD TO BE RETRIEVED BY SNARE. DEVICE USED BY RADIOLOGIST.
ATTORNEY REPORTS CLIENT HAD CATARACT SURGERY IN WHICH PRODUCT WAS USED, ATTY CONVEYS THE OPERATIVE REPORT STATED THAT "THE CANNULA WAS NOT ATTACHED TO THE SYRINGE" AND THS LED TO THE PRODUCT BEING "SHOT INTO THE EYE." ATTY STATES CLIENT IS "PRACTICALLY BLIND IN THE LEFT EYE." TWO FOLLOW UP SURGERIES WERE PERFORMED TO ALLEVIATE PAIN AND TO ATTEMPT TO RESTORE VISION WITH NO SUCCESS. ADD'L INFO FROM SURGEON: SURGEON REPORTS HE BELIEVES PRODUCT ESCAPED FROM THE SYRINGE TIP PRIOR TO CANNULA PLACEMENT AND THIS CAUSED INADEQUATE FASTENING OF THE CANNULA TO THE SYRINGE. THE SYRINGE TIP WENT THROUGH THE LENS CAPSULE AND INTO THE VITREOUS. HE REPORTS PT'S CURRENT VA AS 20/80. ADD'L INFO FROM OPHTHALMOLOGIST. PT WAS REFERRED TO APPROX 1 MONTH POST-OPERATIVE: OPHTHALMOLOGIST REPORTS HE IS UNAWARE OF ANY ADVERSE EVENT RELATED TO PRODUCT USE. HE UNDERSTOOD SURGERY WAS COMPLICATED AND THE POSTERIOR CAPSULE WAS RUPTURED. HE REPORTS PT IS SEVERELY DIABETIC WITH MANY COMPLICATIONS INCLUDING SEVERE MACULAR EDEMA.
NO PRODUCT WAS RETURNED TO THE MFR FOR EVALUATION. THIS REPORT WAS MAILED IN TO FDA ON 10/29/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21 CR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATIORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
X-TUBE ASSM 17" X 17". DEALER CLAIMS: X-TUBE IS BROKEN AT THE BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA  THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ON 10/24/96, AT APPROX. 12:30 AM RN, RECEIVED A CALL FROM NURSING HOME INFORMING HER THAT THE PUMP WAS ALARMING UP-OCCLUSION, DOWN OCCLUSION, AND LOW BAG. THE NURSE STATED THAT IT WAS "FINE NOW". ABOUT 3:30 AM, A NEW BAG WAS APPLIED. THE PUMP DISPLAYED A REPROGRAMMED RATE TO DELIVER AT 11.6 ML/HR IN THE PCA PROFILE AT 4:00 AM THE PT EXPIRED FROM AN APPARENT OVERDOSE. THE PUMP WAS PROGRAMMED FOR PCA PROFILE, WITH A CONCENTRATION OF 10ML/HR, BASAL RATE WAS 8 MG/HR.
THE PUMP WAS EXAMINED BY CO ENGINEERING DEPT AND REPORTED THE FOLLOWING: PHYSICAL EXAMINATION - NO ABNORMALITIES WERE OBSERVED. FUNCTION TESTING - ALL TESTED FUNCTIONS PERFORMED NORMALLY. DATA EXAMINIATION - DATA WAS DOWNLOADED FROM THE PUMP AND EXAMINED. THE PUMP WAS FOUND TO BE PROGRAMMED IN A PCA PROFILE WITH A BASAL RATE OF 6 MG/HR. A CONCENTRATE OF 0.6 MG/ML, AND NO BOLUS. THE RATE WAS LATER TITRATED TO 7 MG/HR. CONCLUSION - THE PUMP WAS FOUND TO  BE ACCURATE AND FULLY FUNCTIONAL. THERE IS NOTHING REMARKABLE IN THE DATA AND THE PUMP PERFORMED EXACTLY AS IT WAS PROGRAMMED. AS A RESULT OF PROGRAMMING THE PUMP WITH A CONCENTRATION OF 0.6 MG/ML INSTEAD OF 10 MG/ML (THE ACTUAL CONCENTRATION AS REPORTED), THE DELIVERED DOSE RATE WAS 16.7 TIMES FASTER THAN THE INTENDED DOSE RATE.
CONCLUSION CODE #68 WAS ASSIGNED TO BLOCK H6 AS THE PRODUCT WAS USED AGAINST LABELED RECOMMENDATIONS.
X-TUBE ASSM 18" X 16". DEALER CLAIMS: THE X-TUBE ASSEM IS BROKEN IN THE CTR.
PART OF FORCEPS JAW SEPARATED IN PT AND WAS RETRIEVED.
PROBLEM MOST LIKELY OCCURRED DUE TO EXCESSIVE FORCE BEING APPLIED TO THE FINGER RING; MAY HAVE BEEN EXACERBATED BY CONDITION OF TISSUE OR OTHER OBJECT GRASPED.
THE CATHETER WAS PLACED VIA THE JUGULAR VEIN FOR CHEMOTHERAPY ON 12/20/95. IT WAS REPORTED THAT THE CATHETER BROKE AND EMBOLIZED. THE CATHETER FRAGMENT WAS REMOVED BY CATHETERIZATION ON 4/24/96.
AN ANNULAR DEPRESSION WAS NOTED .75" FROM THE DISTAL END, INDICATING A SUTURE SITE. WHEN THE CATHETER WAS FLUSHED AND PRESSURIZED, THE TUBING BALLOONED AT THE SUTURE SITE. UNDER MAGNIFICATION, THE SURFACE TEXTURE AT THE BREAK SITE WAS FINELY GRANULAR, SEMI-GLOSSY AND SMOOTH ON ONE SIDE, AND DULL AND ROUGH ON THE OTHER SIDE. IT APPEARED THE TUBING HAD BEEN TORN AWAY FROM THE BREAK ON THE ROUGHER SIDE. THIS TYPE OF DAMAGE INDICATES A BREAK THAT BEGAN WITH A TEAR. THIS DAMAGE MAY HAVE OCCURRED UNNOTICED AT PLACEMENT, AND BROKE COMPLETELY THROUGH USE AND/OR THE NATURAL MOVEMENT INSIDE THE BODY.
DEVICE USED FOR VENIPUNCTURE, THE TECH ASPIRATED IV AND BLOOD APPEARED ON THE OUTSIDE OF THE TUBING. A SMALL AMOUNT OF IV CONTRAST WAS INJECTED AND THE CONTRAST SPURTED OUT THROUGH TWO HOLES IN THE TUBING. THE IV WAS IMMEDIATELY DISCONTINUED AND THE NURSE WAS NOTIFIED. THE PT HAD TO ENDURE ANOTHER VENIPUNCTURE TO COMPLETE THE TEST.
REAR S/F DAB PNTD R Q2. DEALER CLAIMS: BROKEN WHERE THE BACK CANES ATTACH.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA  THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
IT WAS REPORTED THAT DURING A DILATATION PROCEDURE, A HOLE DEVELOPED IN THE CATHETER BALLOON ON THE 1ST INFLATION. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE TO COMPLETE THE PROCEDURE. NO PT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.
THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR. H6, METHOD CODE 86, USED AS THE SAMPLE WAS DISCARDE BY THE FACILITY AND NO METHOD IS POSSIBLE FOR EVAL.
IT WAS REPORTED TO CO THAT THE TABLE END CAP SLID OFF THE END OF THE NUCLEAR MEDICINE TABLE AND THAT THE OPERATOR MAY LOSE THEIR GRIP OR BALANCE AND COULD FALL. NO INJURY WAS REPORTED.
MODIFICATION OF THE DESIGN IS BEING INVESTIGATED.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X BAR FRAME BROKE AT LEFT SIDE GOING UP.
THE DEVICE WAS USED DURING A DIAGNOSTIC LAPARSCOPIC PROCEDURE. UPON ENTRY, A SMALL HEMATOMA WAS OBSERVED ON THE SMALL BOWEL MESENTERY. THE HEMATOMA WAS CAUTERIZED. THE CASE WAS COMPLETED AND THE PT RELEASED.
THE SURGEON PERFORMING THE SURGERY ACKNOWLEDGED THAT HIS SURGICAL TECHNIQUE CAUSED THE HEMATOMA. THE DEVICE INVOLVED IS NOT EXPECTED TO BE RETURNED. THE PROCEDURE WAS PERFORMED BY DR AND WAS CONDUCTED WITHOUT INSUFFLATION, CONTRARY TO STANDARD PRACTICE AND PRODUCT LABELING. PRODUCT LABELING AND STANDARD PRACTICE FOR LAPAROSCOPIC SURGERY REQUIRES THE USE OF INSUFFLATION TO AVOID INJURY TO INTERNAL ORGANS AND VASCULATURE. DR HAS ACKNOWLEDGED THAT HIS TECHNIQUE CAUSED THE HEMATOMA AND NOT THE DEVICE. THE CO ANTICIPATES NO FURTHER SUBMISSIONS. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING? NO. IS FREQUENCY GREATER FOR THIS EVENT THAN USUAL? NO. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING? YES. IS SEVERITY GREATER FOR THIS EVENT THAN USUAL? NO.
HOSP REPORTS LENS WAS EXPLANTED DUE TO INJURY TO THE EYE. AN ANTERIOR CHANMBER LENS WAS IMPLANTED.
NO ADD'L INFO HAS BEEN RECEIVED, DESPITE REQUEST TO USER FACILITY IN THE FORM OF AIRBORNE LETTER, REGARDING RELATIONSHIP OF LENS TO REPORTED EYE INJURY. THE LENS WAS RETURNED WITH BLOOD AND SOLUTION ON THE SURFACE. NO DEFECTS WERE NOTED. THIS REPORT WAS MAILED IN TO FDA ON: 10/39/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
SURGEON WAS FILLING A DEFECT LEFT FROM A TRANS LAB PROCEDURE. HE USED A 25 GRAM VIAL OF BONESOURCE. THE MATERIAL SEEMED SOMEWHAT TACKY AFTER ABOUT 20 MINS. HOWEVER, IT DID HARDEN WITH SOME ADD'L TIME. POST OPERATIVELY, THE DRAIN WAS REMOVED AND THE PT DEVELOPED A CSF LEAK WHICH WAS CURED WITH A PRESSURE DRESSING. DISTRIBUTOR IS NOT CERTAIN IF THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
IT WAS REPORTED TO CO THAT THE ADHESIVE THAT HOLDS THE MOUNTING BRACKETS TO THE NUCLEAR MEDICINE CRADLE EXTENDER MAY FAIL UNDER EXCESS FORCE (SUCH AS FROM SITTING OR LEANING ON THE EXTENDER). THIS WOULD CAUSE THE EXTENDER TO NOT FIT AS TIGHTLY TO THE TABLE, AND MAY CAUSE IT TO SLIP OFF THE TABLE OR NOT SUPPORT THE WEIGHT APPLIED TO IT. NO INJURY WAS REPORTED. WARNINGS ARE PROVIDED IN THE OPERATOR MANUAL AND ON THE EXTENDER.
DURING A VISIT TO A FACILITY, THE REP. NOTED THAT AN IV INFUSION WAS BEING ADMINISTERED WITHOUT THE TUBING BEING IN AN INSTRUMENT (VIA GRAVITY), AND THE PT RECEIVED AN OVERINFUSION OF MEDICATION. THE RATE WAS 10CC/HR AND 1 LITER EMPTIED IN 1.5 HRS. THE PT EXPERIENCED SOME CONSEQUENCE AND WAS TRANSFERRED TO ICU.
THIS ENTIRE MEDWATCH REPORT WAS COMPLETED BY THE DEVICE MFR. NO REPORT OR INFO WAS FURNISHED OR OBTAINED FROM THE USER FACILITY. THE DEVICE WAS DISCARDED BY THE USER FACILITY AND IS NO LONGER AVAILABLE FOR INVESTIGATION, THEREFORE, NO FAILURE CONCLUSION CAN BE MADE.
AFTER ACQUISITION OF GATED STRESS TOMO, GANTRY HEADS WERE MOVING APART. TECH STARTED TO PULL BED AWAY FROM CAMERA. MOTION INTERRUPT MESSAGE CAME ON SCREEN. TECH PRESSED STOP ON THE SCRREN AND SELECTED PREPARE GANTRY OPTION. TECH THEN HIT BOTH SAFETY PADS ON GANTRY HEADS, AND PRESSED START. THE GANTRY ROTATED COUNTER CLOCKWISE AND THE GANTRY HEAD ANGULATION ARM OF HEAD 2 HIT THE PT'S FOREHEAD.
CUSTOMER ELECTED NOT TO HAVE CO EVALUATE THE FAILURE.
IT WAS REPORTED A FILTER DID NOT OPEN FOLLOWING DEPLOYMENT VIA A FEMORAL APPROACH. A SECOND FILTER WAS SUCCESSFULLY PLACED WITH NO PT COMPLICATIONS. THIS DEVICE REMAINS IMPLANTED, THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. IT WAS INDICATED A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO FILTER PLACEMENT AND CONTINUAL FLUSHING OF THE CARRIER SYSTEM DURING THE IMPLANT PROCEDURE WAS NOT PERFORMED WHICH CO BELIEVES MAY HAVE CONTRIBUTED TO THIS EVENT. CO DIRECTIONS FOR USE STATE: "AN INFERIOR VENA CAVOGRAM MUST BE PERFORMED PRIOR TO VENA CAVA FILTER INSERTION. THIS PROCEDURE DETERMINES CAVAL PATENCY AND DIAMETER AND IS USED TO EVALUATE THE INFERIOR VENA CAVA FOR THE PRESENCE OF THROMBUS AND CONGENITAL ANOMALIES. DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER. IN MOST CASES A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE. THE INTRODUCER CATHETER MUST BE FLUSHED THROUGH THE FLUSH PORT BY FREQUENT INJECTION OR CONTINUOUS INFUSION OF STERILE HEPARINIZED SALINE DURING THE IMPLANT PROCEDURE. INSUFFICIENT FLUSHING CAN ALLOW THROMBUS FORMATION INSIDE THE VENA CAVA FILTER WHICH CAN BIND THE LEGS AND PREVENT COMPLETE OPENING UPON RELEASE".
X-TUBE ASSEMBLY 20" X  16". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
DURING ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY, THE STENT MIGRATED OFF THE BALLOON CATHETER AND EMBOLIZED WITHIN THE CORONARY CIRCULATION. AN INTIMAL TEAR AND TEMPORARY OCCLUSION OF THE RIGHT CORONARY ARTERY OCCURRED. THE EMBOLIZED STENT WAS SUCCESSFULLY RETRIEVED USING A MICROSNARE. THREE ADDITIONAL CORONARY STENTS WERE SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
PT HAS TOTAL FACIAL NERVE PARALYSIS ON THE IMPLANTED SIDE FOLLOWING IMPLANT SURGERY. THE SURGEON HAS BEEN CONTACTED FOR FURTHER INFO.
X-TUBE ASSEMBLY 18" X 14". DEALER CLAIMS X-TUBE BROKE AT THE TOP LEFT HAND SIDE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA  THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REORTABLE EVENT.
ON DIAL USED TO SELECT AMOUNT OF INSULIN TO INJECT IF PT OVER DIALS AND TURNS DIAL BACK TO CORRECT AMOUNT, THE AMOUNT OF OVERDIAL IS INJECTED OR WASTED OUT TIP OF NEEDLE. RPTR FEELS THERE SHOULD BE A SAFETY TO AVOID THIS.
RECEIVED MEDWATCH DATED 9/6/96, STATING "CLIP APPLIER USED DURING PROSTATE SURGERY. TIP WAS BROKEN DURING THE OPERATIVE PROCEDURE AND NOTED BY THE SCRUB ASSISTANT. THERE IS NO INJURY TO THE PT. PIECE WAS NEVER RETRIEVED. ONCE PROCEDURE WAS OVER, THE APPLIER WAS ACCIDENTALLY DROPPED ON THE FLOOR AND THE ORIGINAL AREA WITH PIECE BROKEN INCREASED IN SIZE. DUE TO THE MINUTE SIZE, THIS PIECE COULD NOT BE FOUND."
DURING ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY, A DISSECTION WAS NOTED. THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT. THE STENT AND DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION. A SECOND CORONARY STENT WITH DELIVERY SYSTEM WAS SUBSEQUENTLY SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE. DURING ATTEMPTS TO ADVANCE A THIRD CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE, THE STENT DISLODGED FROM THE BALLOON CATHETER AND EMBOLIZED WITHIN THE CORONARY CIRCULATION. THE PT WAS SENT FOR EMERGENCY CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
A1,4; B6,7; D10; F5,12: INFO NOT PROVIDED ON UF'S MEDWATCH FORM. D5,6; F9; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
THE RESULTS AND CONCLUSIONS: THE ACTUAL DEVICE FUNCTIONED TO AND MEETS ORIGINAL SPECIFICATIONS. THE DEFECT DESCRIBED COULD NOT BE DUPLICATED IN TEST.
X-TUBE ASSEMBLY 19" X 18". DEALER CLAIMS TUBE BROKE AT THE CTR BOLT.
CUSTOMER COMPLAINED VARIOUS SIZE CITRATE TUBES GIVE VARYING APTT RESULTS. IT WAS REPORTED THE MAJORITY OF THE DISCREPANT RESULTS OCCURRED IN SAMPLES FROM HEPARINIZED PTS TESTED WITH THE REDUCED DRAW TUBES; AND THAT THE RESULTS WERE SPURIOUSLY LOW.
PRELIMINARY CLINICAL EVAL OF THESE LOTS ON AN MLA 700 INSTRUMENT, USING ANOTHER CO'S REAGENT HAVE CONCLUDED NO SIGNIFICANT DIFFERENCES BETWEEN TUBES. DATA SUBMITTED BY CUSTOMER ON A SECOND CO'S INSTRUMENT, USING THIRD CO'S FSL REAGENTS PROVIDE SIGNIFICANT CLINICAL DIFFERENCES ON APTT COAGULATION RESULTS FOR HEPARINIZED PTS. FURTHER TESTING HAS BEEN ORDERED TO RULE OUT ANY INSTRUMENT/REAGENT INTERFERENCES. CO STANDARD PRODUCT INSERT STATES "THE CLINICAL LABORATORY SHOULD ESTABLISH/VERIFY ITS REFERENCE RANGES IF CHANGING SPECIMEN COLLECTION TUBE TYPES AND SIZES, AS THIS COULD POTENTIALLY AFFECT ANALYTIC RESULTS FROM PT SAMPLES". ROOT CAUSE IS UNDERTERMINED AT THIS TIME, AND FURTHER INVESTIGATION HAS BEEN INITIATED. COMMENTS: BOX H1 ON MEDWATCH FORM 3500A WAS MARKED AS OTHER, AS THE INCIDENT REPORTED REC'D APPROPRIATE CLINICAL REVIEW OF COAGULATION TEST RESULTS, AND DID NOT INVOLVE ALTERATION OF PT TREATMENT OF ANY KIND. BOXES F11 AND F13 WERE MARKED "YES" AS REPORT WAS REC'D THROUGH A LETTER FROM THE USER FACILITY, AND NOT BY A MEDWATCH USER FACILITY REPORT.
OCCLUDING CLAMP BROKEN AT THE TOP, REQUIRING ALTERNATE MEANS OF OCCLUDING CATHETER TO PREVENT POSSIBLE AIR EMBOLUS. PT REHOSPITALIZED TO CORRECT PICC OR DC WHILE HOSPITALIZED.
PT UNDERGOING ANTERIOR CORPECTOMY AT C6 WITH STRUT GRAFTING AND PLATING. WHEN SURGICAL DRAPES WERE REMOVED FROM PT, AND THE ELECTRODE CONNECTONS WERE REMOVED BURNS WERE NOTED AT THE MOTOR RECORDING SITES AS WELL AS THE PT GROUNDING SITES FOR THE MOTOR EVOKED POTENTIAL. FOUR BURNS TOTAL AT THE LEFT & RIGHT HIP (3RD DEGREE) AND ALSO AT THE LEFT & RIGHT CALF.
PT CALLED HOME CARE TO REPORT A CLAMP BROKEN ON PICC LINE INSERTED BY INTERVENTIONAL RADIOLOGY WHICH HE WOULD LIKE TO HAVE REPLACED. NO REPLACEMENT AVAILABLE. REPORTED TO MD AND PICC REMOVED UPON CLINIC VISIT.
THE PRESSURE TRANSDUCER LEAKED BLOOD INTO THE DEVICE DURING USE. THE CONSOLE WAS CHANGED OUT WITH NO AFFECT TO THE PT.
HOSP DID NOT FILE A REPORT FOR THIS MALFUNCTION. THE INFO IN SECTIONS A,B, C,D, E AND F WAS OBTAINED FROM THE INITIAL COMPLAINT. NO OTHER INFO AVAILABLE AT THIS TIME. REASON FOR RETURN WAS DUPLICATED. ALCOHOL WARNING LABEL NEEDS TO BE ADDED TO FRONT PANEL PER UPDATE. THERE IS SIGNIFICANT BLOOD CONTAMINATION INSIDE THE CONSOLE. THE PRESSURE BOARD AND THE DIGITAL OUTPUT BOARDS ARE COMPLETELY COVERED WITH BLOOD. SVC PERFORMED: INTERNAL BLOOD WAS CLEANED OUT. PRESSURE TRANSDUCER WAS REPLACED TO RESOLVE REASON FOR RETURN. REPLACED PRESSURE BOARD AND DIGITAL OUTPUT BOARDS DUE TO BLOOD CONTAMINATION. ADDED MOTOR DRIVE CABLE AND LONG AND SHORT ANALOG CABLES DUE TO NEW PRESSURE BOARD. ADDED ALCOHOL WARNING LABEL PER UPDATE. CONSOLE WAS CLEANED, CALIBRATED AND FINAL TESTED. CONSOLE MEETS FINAL TEST SPECS. BAUD RATE=9600. HANDSHAKING IS HARDWARE. DATA LINK IS FORMAT, DATA RATE IS 1 SECOND. TIME IS 1:53:35. SVC LOANER SERIAL NUMBER 6292 WAS PROVIDED.
POST HOSPITALIZATION LT ARM HAD A BROKEN OCCLUDING CLAMP REQUIRING ALTERNATE MEANS OF OCCLUDING CATHETER TO PREVENT POSSIBLE AIR EMBOLI. DR STATES CATHETER WOULD NOT BE USED UNLESS CLAMP DEFECT CORRECTED.
A PIECE OF METAL FILING WAS LEFT ON THE AORTA AFTER USE OF AN AORTIC PUNCH. THE SURGEON WAS ABLE TO REMOVE THE FILING FROM THE AORTA. NO ADVERSE AFFECTS TO THE PT WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVAL HOWEVER PRODUCTS FROM THE SAME LOT NUMBER WERE RETURNED FOR ANALYSIS ON 10/7/96.
H3 ANALYSIS: THE DEVICE REPORTED WAS NOT RETURNED FOR ANALYSIS. HOWEVER 27 PUNCHES FROM THE SAME LOT WERE RETURNED AND EVALUATED. RESULTS OF THE ANALYSIS SHOW THAT NO METAL FILINGS WERE VISIBLE AT ANY TIME DURING THE EVALUATION. AS THE REPORTED EVENT WAS NOT ABLE TO BE REPRODUCED, NO CONCLUSION CAN BE DRAWN.
X-TUBE ASSM 19" X 17". DEALER CLAIMS: BROKEN X-TUBE CTR HOLE.
A PT UNDERWENT ANTERIOR CORPECTOMY AT C6 WITH STRUT GRAFTING & PLATING. WHEN SURGICAL DRAPES WERE REMOVED FROM PT, AND THE ELECTRODE CONNECTIONS WERE REMOVED, BURNS WERE NOTED AT THE MOTOR RECORDING SITES AS WELL AS THE PT GROUNDING SITE FOR THE MOTOR EVOKED POTENTIAL. FOUR BURNS TOTAL AT THE LEFT & RIGHT HIP (3RD DEGREE) AND ALSO AT THE LEFT & RIGHT CALF." THE CUSTOMER WAS CONTACTED AND INDICATED THAT SURGICAL INTERVENTION WAS NECESSARY.
THE CUSTOEMR WAS CONTACTED AND THE MONITORING ELECTRODES IN USE WERE NEEDLE TYPE. CO CAUTIONS THE USER AGAINST THIS TYPE OF MONITORING ELECTRODE. ADD'L INFO OBTAINED INDICATED THAT THE INDEPENDENT TEST RESULTS OF THE GENERATOR HAD BEEN COMPLETED. THE GENERATOR WAS FOUND TO FUNCTION PROPERLY, WITHIN ALL SPECIFICATIONS AND RETURNED TO USE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF  OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PROVILEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
CUSTOMER REPORTED ERRATIC READINGS. HE OPENED THE BOTTLE OF TEST STRIPS 2 WEEKS AGO. HE STATED THAT SOME OF THE TEST STRIPS SEEMED TO PERFORM ACCURATELY, BUT OTHERS GAVE RESULTS IN THE 10-30 MG/DL RANGE. HE PERFORMED THREE BACK TO BACK READINGS AND THE RESULTS WERE 10 MG/DL, 133 MG/DL, AND 27 MG/DL. ALL TESTS WERE PERFORMED WITHIN TEN MINUTES. THE CODE WAS SET CORRECTLY IN THE CUSTOMER'S METER. THE DESICCANT IS IN THE BOTTLE. THE CUSTOMER DOES NOT HAVE ANY NORMAL CONTROL SOLUTION, SO A CONTROL SOLUTION TEST WAS NOT PERFORMED. A CHECK STRIP TEST YIELDED A RESULT OF 78 VERSUS A CHECK STRIP RANGE OF 69-93. THE CUSTOMER WAS NOT WILLING TO PERFORM ANY TESTS WITH THE REP. HE STORES THE TEST STRIPS IN THE KITCHEN.
THE CUSTOMER'S RETURNED TEST STRIPS WERE EVALUATED ON 10/9/96. ONE OPENED BOTTLE CONTAINING 7 STRIPS WITH DESICCANT WAS RETURNED TO CO FOR EVAL. TEST RESULTS OF THE RETURNED BOTTLE FELL BELOW THE SPEC FOR BLOOD GLUCOSE ACCURACY, HOWEVER, THE RESULTS ARE NOT ERRATIC IN NATURE. EVAL OF THE DESICCANT INSIDE THE RETURNED BOTTLE INDICATES THAT FAILURE MAY BE DUE TO EXPOSURE TO MOISTURE. THE SOURCE OF MOISTURE EXPOSURE IS UNK. THE RETENTION SAMPLE TEST RESULTS FOR LOT MEET THE SPECS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. THE RETENTION TEST RESULTS ARE ALSO ERRATIC IN NATURE. BASSED ON THE EVAL OF RETENTION SAMPLES, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
THE CATHETER WAS PLACED VIA THE JUGULAR VEIN FOR CHEMOTHERAPY ON 4/24/96. IT WAS REPORTED THAT THE CATHETER BROKE AND EMBOLIZED. THE CATHETER FRAGMENT WAS REMOVED BY CATHETERIZATION ON 9/7/96.
A CATHETER FRAGMENT APPROX. 1.95" LONG WAS RETURNED FOR EVALUATION. UNDER MAGNIFICATION, THE BROKEN END OF THE TUBING WAS SEEN TO BE GLOSSARY WITH SEMI-CIRCULAR STRIATIONS ON THE PEAKED SIDE, AND DULL AND ROUGH ON THE OPPOSITE SIDE. THE PEAKED SIDE APPEARED CONCAVE AND THERE WERE DISTINCT ANGULAR CUT LINES AT THE BASE OF THE PEAK. THIS TYPE OF DAMAGE INDICATES A CUT WITH A SHARP INSTRUMENT. THE DAMAGE MAY HAVE OCCURRED UNNOTICED AT PLACEMENT AND BROKE COMPLETELY THROUGH NATURAL MOVEMENT INSIDE THE BODY.
DOCTOR WAS USING DRILL WITH DRILL BIT TO DRILL HOLES IN THE BONE OF THE KNEE WHEN THE TIP OF THE DRILL BROKE OFF IN THE PT'S BONE. ATTEMPTS WERE MADE TO REMOVE, WITHOUT SUCCESS. PT AND FAMILY WERE NOTIFIED BY THE DR.
DEVICE HISTORY REVIEW COULD NOT BE PERFORMED; NO LOT NUMBER PROVIDED.
THE MD APPLIED THE FIXATOR TO TREAT A FRACTURE OF THE DISTAL RADIUS. APPROX 3 WEEKS LATER THE PT RETURNED TO THE MD'S OFFICE BECAUSE THE BALL JOINT WAS LOOSE. MD RETIGHTENED THE FIXATOR IN HIS OFFICE. THERE WAS NO INJURY TO THE PT. THE FIXATOR HAS SINCE BEEN REMOVED AS PART OF THE PLANNED PROCEDURE.
QR AXLE MAG W/NUT. DEALER CLAIMS BALL BEARING FELL OUT OF AXLE, PER CONSUMER'S MOTHER. AS SHE WAS PUTTING WHEEL ONTO CHAIR SHE NOTICED BALL BEARINGS WERE MISSING.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA  THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ON 10/17/96, A FACILITY NURSE INFORMED THE MFR'S CLINICAL REPRESENTATIVE THAT THE PT WAS PRESENTED TO THE FACILITY OFFICE AND STATED THAT SHE WAS TOLD BY THE PEOPLE AT THE IMPLANTING/ATTENDING FACILITY THAT HER DEVICE "WASN'T WORKING" AND THAT IT WOULD NOT BE UTILIZED ANYMORE. THE PT REQUESTED THIS FACILITY NURSE HELP HER. THE FACILITY NURSE CONTACTED A NURSE AT THE IMPLANTING/ATTENDING FACILITY WHO INFORMED HER THAT THE RESIDUAL VOLUME WAS USUALLY 10CC'S; HOWEVER, OVER THE PAST WEEKS THE RESIDUAL VOLUME =25CC'S. NO DYE STUDY OR DECLOTTING PROCEDURE HAD BEEN PERFORMED. THE IMPLANTING/ATTENDING FACILITY'S NURSE ALSO STATED THAT THE PT'S DISEASE HAD SPREAD AND AS A RESULT, A DECISION WAS MADE NOT TO UTILIZE THE DEVICE IN THE PT'S THERAPY ANY LONGER. TO MFR'S KNOWLEDGE, THE DEVICE REMAINS IMPLANTED ALTHOUGH NOT BEING UTILIZED IN THE PT'S THERAPY.
SINCE THE DEVICE REMAINS IMPLANTED AND A SERIAL NUMBER WAS NOT PROVIDED FOR THE DEVICE, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER  AND A TREND WAS NOT INDENTIFIED. BASED IN THE INFO AVAILABLE, THE CAUSE OF THE DEVICE SLOW FLOW COULD NOT BE DETERMINED. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE IN THIS EVENT.
THE PT, A TYPE II DIABETIC WHO ADMINISTERS INSULIN INJECTIONS, REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH DEVICE. APPROX ONE MONTH AGO, THE PT OPENED THE FIRST BOTTLE FROM THE BOX AND OBTAINED BLOOD GLUCOSE READINGS IN THE 50 MG/DL RANGE WHICH WAS LOWER THAN IS TYPICAL BLOOD GLUCOSE READINGS WITH ANOTHER STRIP. ALTHOUGH HE FELT THESE READINGS WERE LOW, HE CONTINUED TO USE TEST STRIPS FROM THE BOTTLE. SOME TIME THIS WEEK, THE PT WENT TO HIS PHARMACY TO HAVE HIS METER AND TEST STRIPS "CHECKED" BECAUSE OF THE LOW READINGS, THE PHARMACIST PERFORMED BOTH A NORMAL CONTROL SOLUTION TEST AND A CHECK STRIP TEST. THE NORMAL CONTROL SOLUTION TEST RESULT WAS OUT OF RANGE (LOW END), BUT THE CONTACT CANNOT REMEMBER THE SPECIFIC RESULT. THE CHECK STRIP TEST RESULT WAS IN RANGE (SPECIFIC RESULT UNAVAILABLE). THE CONTACT DOES NOT KNOW IF THE PHARMACIST SHOOK THE CONTROL SOLUTION. THE CONTROL SOLUTION WAS OPENED THE DAY THE NORMAL CONTROL SOLUTION TEST WAS PERFORMED. THE DESICCANT IS IN THE BOTTLE. THE PT'S METER WAS SET TO THE APPROPRIATE CODE. THE PT STORES THE TEST STRIPS IN HIS KITCHEN.
CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 10/22/96. ONE OPENED BOTTLE CONTAINING 12 STRIPS WITH DESICCANT WAS RETURNED TO CO FOR EVAL. THE TEST RESULT OF THE RETURNED BOTTLE FELL BELOW THE SPECS FOR BLOOD GLUCOSE ACCURACY AND NORMAL CONTROL RANGE, AND CONFIRMED THE COMPLAINT OF LOW BLOOD GLUCOSE AND NORMAL CONTROL READINGS. EVAL OF THE DESICCANT INSIDE THE RETURNED BOTTLE INDICATES THAT FAILURE MAY BE DUE TO EXPOSURE TO MOISTURE. THE SOURCE OF MOISTURE EXPOSURE IS UNK. THE RETENTION SAMPLE TEST RESULTS FOR LOT MEET THE SPECS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE EVAL OF RETENTION SAMPLES, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW.
PT PLACED ON PASSIVE RESISTANCE MOTION DEVICE FOR LEFT LEG FOLLOWING TOTAL KNEE REPLACEMENT. DEGREE OF RANGE AND SPEED SET BY ATTACHED HAND CONTROL. HAND CONTROL ATTACHED TO UNIT BY CORD BUT NOT MOUNTED OR CLIPPED. HAND CONTROL FELL OFF PT'S BED DURING EVENING SHIFT AND HIT THE FLOOR. UNIT MALFUNCTIONED, GOING TO FULL RANGE, BEYOND PRESCRIBED RANGE AND LOCKED UP. PT UNABLE TO RESET IN GREAT PAIN AND STAFF HAD TO INTERVENE.
THE UNIT WAS SENT IN TO BE REPAIRED. THE SYMPTOM WAS THAT THE MONITOR WOULD INTERMITTENTLY TURN OFF. THERE HAS BEEN NO PT DEATH OR INJURY. IF THIS MALFUNCTION WERE TO REOCCUR, IT COULD NOT DIRECTLY INJURE A PT, BUT COULD REDUCE THE ABILITY OF THE USER TO KNOW IF DEFIBRILLATION OR PACING WAS REQUIRED.
A BENT LOCKING TAB ON PIN 1 OF CONNECTOR CO HAS ALLOWED THE PIN TO PARTIALLY WITHDRAW FROM THE CONNECTOR. THAT RESULTED IN AN INTERMITTENT CONTACT. THE EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THIS MALFUNCTION HAS NOT BEEN OBSERVED BEFORE, AND NO ADD'L ACTION IS ANTICIPATED.
DURING IAB INSERTION THE SURGEON WAS UNABLE TO ADVANCE THE BALLOON PAST THE SHEATH. THE IAB WAS REPLACED WITHOUT INCIDENT. THE PT REMAINS IN CRITICAL CONDITION IN THE ICU WITH IAB SUPPORT.
QR AXLE W/NUT. DEALER CLAIMS BALL BEARINGS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT OT RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS IMPLANTED ON 9/2/96. ON 9/30/96, THE MFR RECEIVED A LETTER FROM THE FACILITY'S DIRECTOR OF RISK MGMT WHICH STATED THAT "APPARENTLY, THE CATHETER HAS A WEAKENING IN THE LUMEN WALL WHICH CAUSES IT TO BLOW UP WHEN PLACED NECESSITATING IMMEDIATE REMOVAL." THE FACILITY'S DIRECTOR OF RISK MGMT REQUESTED THAT A MFR REPRESENTATIVE COME BY AND PICK UP THE DEVICE AT HER OFFICE SO THAT AN ANALYSIS COULD BE PERFORMED.
THE 5-1/2" SEGMENT OF DEVICE CATHETER WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED WITH THE FOLLOWING RESULTS: THE DEVICE CATHETER APPEARED CUT AT AN ANGLE ON ONE END AND AT THE STRAIN RELIEF ON THE OPPOSITE END. WHEN APPLYING APPROX 30 PSI WITH AIR AND FLUID, BALLOONING WAS SEEN APPROS 1-3/4" FROM THE STRAIN RELIEF. THIS AREA APPEARED NECKED-DOWN WHEN STRETCHING THE DEVICE CATHETER INDICATING WEAKENING OF THE MATERIAL IN THIS AREA. THE UNIT WAS PATENT AND DID NOT LEAK WHEN PRESSURIZED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CATALOG/LOT NUMBER AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CATALOG/LOT NUMBER AND NO TRENDS OR OTHER REPORTS OF THIS NATURE WERE IDENTIFIED. THE FACILITY'S REPORT THAT THE DEVICE "CATHETER HAS A WEAKENING IN THE LUMEN WALL" APPEARS TO BE CONFIRMED BY THE MFR'S ANALYSIS OF THE RETURNED DEVICE CATHETER; HOWEVER, BASED ON THE AVAIALBLE INFO, THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE IN THIS EVENT.
DURING A PTCA PROCEDURE, THE BALLOON INITIALLY WOULD NOT HOLD PRESSURE. IT WAS ALSO REPORTED THAT THE BALLOON WOULD NOT DEFLATE. A SYRINGE WAS USED TO DEFLATE THE BALLOON. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED SIGNIFICANT TWISTS AND KINKS ALONG THE ENTIRE SHAFT LENGTH. DUE TO THE DAMAGED CONDITION OF THE CATHETER, TESTING RELATIVE TO THE REPORTED DEFLATION DIFFICULTIES COULD NOT BE PERFORMED.
QR AXLE MAG W/NUT. DEALER CLAIMS RELEASE BEARINGS HAVE FALLEN OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING INSERTION, THE SURGEON WAS UNABLE TO ADVANCE THE IAB PAST THE SHEATH. THE IAB WAS REMOVED AND A SECOND WAS INSERTED WITHOUT INCIDENT. THE PT REMAINS IN CRITICAL CONDITION IN THE ICU WITH IAB SUPPORT. ON 8/15/96, ALSO RECEIVED THE MANDATORY MEDWATCH FORM FROM THE DISTRIBUTOR UF/DIST REPORT #2026191-1996-0037).
ALLERGIC REACTION TO LATEX GLOVES. RPTR'S HANDS BECOME RED WITH SWELLING, SEVERE ITCHING, BLEEDING, CRACKED SKIN AND BLISTERS ON THE TOP AND BOTTOM OF BOTH HANDS. SOME OF REACTIONS WERE CAUSED BY THE GLOVES LEAKING.
THE INSTRUMENT WAS USED DURING A HARTMANS II. IT WAS REPORTED DR. WAS TAKING DOWN A COLOSTOMY BAG. SHE FIRED THE INSTRUMENT. THERE WAS NO SIGN OF ANY STAPLES THAT SHOULD HAVE CLOSED THE ANASTOMOSIS. SHE HEARD AN AUDIBLE CLICK AND GOT PERFECT "DONUTS" BUT NO SIGN OF STAPLES IN THE BODY OR STAPLER. BOWEL CONTENTS SPILLED INTO THE ABDOMEN. MEDICATION WAS REQUIRED. PT REPORTEDLY DOING WELL NOW. 10/17/96 SURGEON WAS PERFORMING A ANTERIOR RESECTION FOR DIVERTICULAR DISEASE CAUSING MASSIVE COLONIC BLEEDING. THE PT HAD SIGNIFICANT INFLAMMATORY DISEASE WITHIN THE PELVIS. A RELATIVELY LOW ANTERIOR ANASTOMOSIS WAS PERFORMED. THE CDH APPEARED TO FUNCTION NORMALLY. TWO GOOD DONUTS WERE OBTAINED, HOWEVER, THERE WERE NO STAPLES FIRED. THERE WAS NO ANASTOMOSIS. THE INSTRUMENT IS BEING RETURNED FOR EVALUATION. THE SURGEON PROCEEDED TO DO A HAND SEWN, LOW ANTERIOR ANASTOMOSIS USING A SINGLE LAYER OF SUTURES. THERE WAS NO LEAK. THE PT HEALED AND LEFT THE HOSPITAL IN A NORMAL LENGTH OF TIME. IN THE POST OPERATIVE PERIOD THE PT DEVELOPED A COLOVAGINAL FISTULA. THE DR HOPES TO REPAIR IT THROUGH A VAGINAL APPROACH IF POSSIBLE. THE INSTRUMENT IS BEING RETURNED TO CO.
D6; DEVICE RETURNED WITH NO LOT ID. 10/17/1996 SURGEON WAS PERFORMING A ANTERIOR RESECTION FOR DIVERTICULAR DISEASE CAUSING MASSIVE COLONIC BLEEDING. THE PT HAD SIGNIFICANT INFLAMMATORY DISEASE WITHIN THE PELVIS. A RELATIVELY LOW ANTERIOR ANASTOMOSIS WAS PERFORMED. THE CDH APPEARED TO FUNCTION NORMALLY. TWO GOOD DONUTS WERE OBTAINED, HOWEVER, THERE WERE NO STAPLES FIRED. THERE WAS NO ANASTOMOSIS. THE INSTRUMENT IS BEING RETURNED FOR OUR EVAL. THE SURGEON PROCEEDED TO DO A HAND SEWN, LOW ANTERIOR ANASTOMOSIS USING A SINGLE LAYER OF SUTURES. THERE WAS NO LEAK. THE PT HEALED AND LEFT THE HOSP IN A NORMAL LENGTH OF TIME. IN THE POST OPERATIVE PERIOD THE PT DEVELOPED A COLOVAGINAL FISTULA. THE DR HOPES TO REPAIR IT THROUGH A VAGINAL APPROACH IF POSSIBLE. THE INSTRUMENT IS BEING RETURNED TO US.
DURING A POST STENT DILATATION PROCEDURE, THE BALLON WOULD NOT DEFLATE PROPERLY. A SYRINGE WAS USED TO DEFLATE THE BALLOON ENOUGH TO REMOVE. IT WAS OBSERVED THAT THE BALLOON WAS WINGED. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED THE BALLOON DEFLATION MET SPECS. WINGING OF THE BALLOON WAS OBSERVED. WINGING AFTER INFLATION/DEFLATION IS EXPECTED WITH THIS TYPE OF BALLOON MATERIAL. NO MATERIAL OR MANUFACTURING DEFICIENCIES WERE NOTED.
UPON REMOVAL OF AN IAB CATHETER, BLOOD WAS NOTICED IN THE HELIUM LINE INDICATING THE BALLOON HAD RUPTURED.
CUSTOMER REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS. HE PURCHASED 2 BOXES OF TEST STRIPS APPROX TWO WEEKS AGO. HE IMMEDIATELY NOTICED THAT HIS READINGS WERE SIGNIFICANTLY LOWER THAN HIS USUAL READINGS. HE CALLED CO TO REPORT THE LOW READINGS. THE REP SAID THAT, MOST LIKELY, THE DEVICE WAS CAUSING THE PROBLEM. THE REP REQUESTED THAT THE CUSTOMER SEND THE TEST STRIPS FOR EVAL, WHICH HE DID. THE CUSTOMER OPENED THE SECOND BOX OF TEST STRIPS WITH THE CO REP AND PERFORMED A SIDE BY SIDE COMPARISON. THE RESULT WAS 147 MG/DL FROM BOX 1 VERSUS A RESULT OF 87 MG/DL FROM BOX 2. THE CODE WAS SET CORRECTLY FOR ALL TESTS. THE DESICCANT IS IN THE BOTTLE. THE CUSTOMER DOES NOT HAVE ANY NORMAL CONTROL SOLUTION TO TEST EITHER BRAND OF TEST STRIPS FOR ACCURACY. A CHECK STRIP TEST YIELDED A RESULT OF 97 VERSUS A CHECK STRIP RANGE OF 75-104. THE CUSTOMER STORES HIS TEST STRIPS IN HIS KITCHEN.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 10/14/96. TWO BOTTLES, ONE OPENED CONTAINING 24 STRIPS WITH DESICCANT AND ONE UNOPENED CONTAINING 25 STRIPS WITH DESICCANT, WERE RETURNED TO CO FOR EVAL. THE TEST RESULT OF BOTH RETURNED BOTTLES FELL OUTSIDE THE SPEC FOR BLOOD GLUCOSE ACCURACY AND CONFIRMED THE COMPLAINT OF LOW BLOOD GLUCOSE READINGS. ERROR GRID ANALYSIS INDICATES THAT THE TEST RESULTS OF RETURNED TEST STRIPS FALL IN ZONE A AND B, AND DO NOT REPRESENT A REASONABLE RISK OF SERIOUS INJURY. EVAL OF THE DESICCANT INSIDE THE RETURNED BOTTLES INDICATES THAT THE LOW READINGS FROM THE BOTTLES OBTAINED BY CO ARE NOT LIKELY DUE TO EXPOSURE TO MOISTURE. ERROR GRID ANALYSIS BASED ON CUSTOMER REPORTED RESULTS INDICATES THAT CUSTOMER'S TEST STRIPS MAY PRODUCE RESULTS WHICH FALL IN ZONE B, AND DO NOT REPRESENT A RESONABLE RISK OF SERIOUS INJURY. THE RETENTION SAMPLE TEST RESULTS FOR LOT MEET THE SPECS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. TREND ANALYSIS SHOWS THIS IS THE FIRST COMPLAINT OF LOW GLUCOSE READINGS FOR LOT. BASED ON THE EVAL OF RETENTION SAMPLES AND THAT THERE IS ONLY ONE COMPLAINT OF LOW BLOOD GLUCOSE READINGS FOR THIS LOT OVER 12 MONTHS IN DISTRIBUTION, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW.
QR AXLE MAG W/NUT. DEALER CLAIMS: THEIR AXLE WON'T LOCK.
A HOSPITAL LAB TECH WAS USING 5% SULFOSALICYLIC ACID IN PROTEIN TESTING. THE SULFOSALICYLIC ACID HAD BEEN TRANSFERED FROM THE ORIGINAL CONTAINER TO A PLASTIC SQUEEZE BOTTLE. WHEN THE BOTTLE WAS SET DOWN SHARPLY ON THE LAB BENCH IT SPURTED INTO THE LAB TECH'S EYE. THE LAB TECH DID NOT INITIALLY EXPERIENCE ANY PAIN, AND DELAYED WASHING OF THE EYE. LATER LAB TECH EXPERIENCED PAIN, WENT TO EMERGENCY ROOM AND WAS GIVEN FIRST AID TREATMENT AND FOLLOW-UP CARE. THE HOSPITAL LAB MANAGER INDICATED THAT THE LAB HAS TAKEN CORRECTIVE ACTION TO PROHIBIT USE OF THIS SOLUTION IN A PLASTIC SQUEEZE BOTTLE IN THE FUTURE.
INJURY TO LAB TECH CAUSED BY ACCIDENTAL EXPOSURE TO ACID. FURTHER EVALUATION OF THE ACID REAGENT WAS NOT REQUIRED.
ON 10/4/96, THE MFR RECEIVED A RESPONSE TO A DEVICE TRACKING POLLING LETTER FROM THE PHYSICIAN WHICH STATES THAT THE DEVICE WAS EXPLANTED ON 8/14/96 DUE TO DISEASE PROGRESSION AND DEVICE OCCLUSION.
FURTHER CORRESPONDENCE FROM THE PHYSICIAN, RECEIVED ON 10/24/936, STATES THAT "THE DEVICE MALFUNCTION WAS DETECTED AROUND MAY/JUNE 1966, WHILE THE PT WAS UNDER THE CARE OF PHYSICIANS AT ANOTHER FACILITY. THE CENTRAL RESERVOIR WAS NOTED TO BE DULL AFTER TWO WEEKS, INDICATING OCCLUSION OF CATHETER. THE PT CAME TO THIS FACILITY FOR FOLLOW UP CARE. EFFORTS AT MAKING THE CENTRAL RESERVOIR WORK WERE UNSUCCESSFUL (ATTEMPTS AT THROMBOLYSIS AND ANTICOAGULATION). A TECHNETIUM STUDY PERFORMED THROUGH DEVICE SIDEPORT INJECTION WAS DONE, DEMONSTRATING SLOW FLOW INTO LIVER, WITHOUT EXTRAVASATION. HOWEVER, DURING THE SUBSEQUENT WEEKS, SIDE PORT INJECTIONS EVEN UNDER MODERATE PRESSURE WERE UNSUCCESSFUL, INDICATING PROGRESSIVE THROMBOSIS AT/NEAR CATHETER TIP. DID NOT PERFORM ANGIOGRAM; THE PT IN THE MEANWHILE REQUESTED EXPLANTATION, EXPERIENCING UNDUE HARDSHIP MAINTAINING THE DEVICE. HE HAD DISEASE PROGRESSION IN LIVER." AS PART OF INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISTORY RECORD AND A TREAND ANALYSIS WERE PERFORMED, A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INDICENTS INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE PHYSICIAN'S REPORT OF DEVICE OCCLUSION IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED A KINK IN THE INFLATION LUMEN OF THE CATHETER SHAFT. THE KINK MAY HAVE RESTRICTED THE FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A SMOOTH-EDGED PENETRATION WAS SEEN AT THE LEAK SITE WITH NO ACCOMPANYING MARKS. THIS TYPE OF PENETRATION IS TYPICAL OF THAT CAUSED BY CONTACT WITH A SHARP OBJECT. DEVICE LABEL CODE: 1738.
THE FOLLOWING WAS REPORTED TO DATASCOPE ON 9/18/96: THE IAB WAS INSERTED WITH A SHEATH WITH NO DIFFICULTY. BLOOD STARTED TO FLOW BACK. THE IAB LEAKED. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED AND THIS ONE WORKED FINE.
ALLERGIC REACTION TO LATEX AND BITRILE GLOVES. WHEN RPTR COMES IN CONTACT WITH EITHER OF THESE TYPES OF GLOVES HIS HANDS BECOME RED WITH SWELLING, ITCHING, BLEEDING AND BLISTERS.
QR AXLE W/NUT. DEALER CLAIMS BEARING FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENTS BALL. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
EIGHT HOURS WORTH OF FEEDING SOLUTION WAS DELIVERED TO THE PT IN 6 HOURS. NO FURTHER INFO WAS GIVEN.
CO'S STANDARD PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE REPORTER FOR COMPLETION AND RETURN. IN THIS CASE, THE REPORTER DID NOT RETURN A MEDWATCH FORM, THUS THE REQUIRED INFO FOR THE FOLLOWING SECTIONS IS NOT AVAILABLE: A1-A4 , D10; E4; AND F1,F14.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE SEAL RAIL.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA  THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EENT.
THIS EVENT WAS REPORTED AS REGURGITATION, PERIVALVULAR LEAK, PULMONARY HYPERTENSION AND CARDIAC CACHEXIA. NO FURTHER INFO PROVIDED.
H3: EXAMINATION OF THE VALVE IN CO'S LABORATORY REVEALED EIGHT INTACT SUTURES ON THE SEWING RING WHICH IS CONSISTENT WITH THE REPORT OF A TWO CENTIMETER DEHISCENCE NOTED CLINICALLY. NO FURTHER INCONSISTENCIES WERE NOTED. THIS FINDING WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY EXCEPT FOR THE TRICUSPID REGURGITATION. AS AN ADDED NOTE, THIS VALVE DID NOT EXHIBIT ANY OF THE NORMAL WEAR ASSOCIATED WITH THIS TYPE OF DEVICE IMPLANTED FOR THIS DURATION AND WAS, IN FACT, IN EXCELLENT CONDITION. H6: 86=X-RAY ANALYSIS.
VENTRICULAR FIBRILLATION REPORTED TO HAVE OCCURRED DURING AN ABLATION FOR VENTRICULAR TACHYCARDIA. INTERVENTION INCLUDED AN EXTERNAL DEFIBRILLATION. THE PT HAD NO ADVERSE EFFECTS.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CASUAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO DISCLOSED TO THE PUBLIC UNDER THE FOIA. RF ENERGY WAS BEING DELIVERED WHILE THE GENERATOR WAS STILL CONNECTED TO A  STIMULATOR. FREQUENCY AND SEVERITY STATEMENT: CO HAS CONCLUDED THAT THE FREQUENCY OF THE REPORTED EVENT IS NOT GREATER THAN USUAL FOR THE DEVICE.
THIS EVENT WAS REPORTED AS AN INFECTED ABSCESS. NO FURTHER INFO PROVIDED.
ET TUBE KINKED BACK OF PT'S MOUTH. VENTILATOR APPROPRIATELY ALARMED. RT TECH RESPONDED IMMEDIATELY. PT WAS NOT GETTING APPROPRIATE VOLUMES BECAUSE VENT WAS PEAK PRESSURING. COULD NOT ADVANCE SUCTION CATHETER. PT HR STABLE BUT RR INCREASED TO 42 FROM 12 AND TIDAL VOLUMES DECREASED FROM AROUND 800 TO 120 ML. PT'S'SATS STAYED AT 99. IMMEDIATELY NOTED KINKED TUBE IN PT MOUTH. TRIED TO UNKINK THE TUBE. WHEN UNABLE TO ACHIEVE ADEQUATE AIRWAY, PT EXTUBATED WITH NO ADVERSE AFFECTS. PT IS FINE. THE ET TUBE WAS KINKED, WITH A TWIST IN IT. AT THE TIME OF REMOVAL, COULD NOT STRAIGHTEN TUBE. AFTER A PERIOD OF TIME THE ET TUBE STRAIGHTENED ITSELF. PICTURES ARE INCLOSED OF WHAT TUBE LOOKED LIKE AT TIME OF REMOVAL. RGA#96001154. UNIT WILL BE SENT AS SOON AS PICTURES ARE DEVELOPED.
X-TUBE ASSM 18" X 16". DEALER CLAIMS: BROKEN AT THE X BALL.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA  THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CUASED OR CONTRIBUTEDD TO THE REPORTABLE EVENT.
THIS REPORT REFLECTS THE NEW INTO RECEIVED FROM THE USER FACILITY WHO WAS NOT THE ORIGINAL REPORTER. THIS REPORTER DID NOT PROVIDE THE REQUIRED INFO FOR THE FOLLOWING SECTIONS: A (INAPPROPRIATE IDENTIFIER WAS USED); B6, B7; D5-D8, D10;, E4; F2, F9, F10, F11, AND F13.
REPORTER STATED ON MEDWATCH FROM RECEIVED 11/26/1996: "THE FEEDING TUBE WAS NOT COUNTING CORRECTLY. PLACED ON 60 ML/HR. WAS DELIVERING 120 ML/HR THUS OVERFEEDING THE RESIDENT." ADDITIONAL INFO OBTAINED REVEALED 200 ML OF AN ENTERAL FEEDING SOLUTION WERE HUNG, AND THE PUMP WAS SET TO DELIVER 100 ML/HR. 200 ML WERE DELIVERED IN 1 HOUR.
THIS EVENT WAS REPORTED AS MITRAL REGURGITATION, TRANSIENT ISCHEMIC ATTACK AND SHORTNESS OF BREATH. NO FURTHER INFO PROVIDED.
PT HAD A BARRIER PLACED ON 8/9/96 FOR A FURCATION ON TOOTH #3 BUCCAL. ERYTHROMYCIN WAS PRESCRIBED AS THE POST-OPERATIVE ANTIBIOTIC. ORAL HYGIENE INCLUDED PERIDEX APPLIED TO THE SURGICAL SITE WITH A Q-TIP FOR THE FIRST 3 WEEKS, AND THEN BRUSHING WITH AN EXTRA SOFT TOOTHBRUSH AT THE SURGICAL SITE. THE TISSUE SURROUNDING THE BARRIER BECAME RED AND PUFFY, AND CONCERN WAS EXPERESSED BY THE PT'S REGULAR DENTIST THAT AN ABSCESS MAY HAVE BEEN FORMING. AT APPROX 5 WEEKS AFTER PLACEMENT, THE BARRIER WAS REMOVED. NO ABSCESS WAS NOTED, NO SUPPURATION WAS PRESENT, AND THE PT EXPERIENCED ALMOST IMMEDIATE RELIEF OF SYMPTOMS. THE PERIODONTIST SUSPECTS AN ALLERGIC REACTION TO EITHER ANOTHER PRODUCT, CO'S PRODUCT, OR THE COMBINATION OF THE TWO, BUT HAS NO WAY TO VERIFY WHICH ONE IT COULD BE.
SALES REP REPORTS THAT HE OBTAINED THIS INFO FROM THE NURSE COORDINATOR. APPARENTLY THIS INCIDENT OCCURRED ON 9/22/96. THE NEEDLE WAS INSERTED IN THE THIGH (THE NURSE WAS NOT AWARE THAT THE PACKAGE INSERT RECOMMENDS FOR INSERTION IN THE ABDOMEN). IT WAS IN PLACE FOR AT LEAST 7 DAYS, POSSIBLY MORE. THE NURSE HAS A STRONG FEELING THAT REMOVAL OF THE NEEDLE WAS NOT PERFORMED AS PER THE LABEL INSTRUCTIONS. SHE IS REVIEWING THIS WITH THE NURSE INVOLVED. X-RAY REPORT OF THE SITE CONFIRMED A MASS CONSISTENT WITH A NEEDLE. THERE WAS NO ATTEMPT TO RETRIEVE THE NEEDLE DUE TO THE FRAGILE MEDICAL CONDITION OF THIS TERMINALLY ILL PT.
SECTIONF COMPLETED BY BAXTER. NO OTHER INFO IS AVAILABLE. NO SAMPLE OR LOT NUMBER HAS BEEN MADE AVAILABLE FOR EVAL PURPOSES.
THE ENDOTRACHEAL TUBE KINKED IN THE BACK OF THE PT'S MOUTH. VENTILATOR APPROPRIATELY ALARMED. RT TECH RESPONDED IMMEDIATELY. PT WAS NOT GETTING APPROPRIATE VOLUMES BECAUSE VENT WAS PEAK PRESSURING. COULD NOT ADVANCE SUCTION CATHETER. PT HEARTRATE WAS STABLE BUT RESPIRATORY RATE INCREASED TO 42 FROM 12 AND TIDAL VOLUMES DECREASED FROM AROUND 800 TO 120 ML. PT'S SATS STAYED AT 99. IMMEDIATELY NOTED KINKED TUBE IN PT MOUTH. TRIED TO UNKINK TUBE. WHEN UNABLE TO ACHIEVE ADEQUATE AIRWAY, PT WAS EXTUBATED WITH NO ADVERSE EFFECTS. PT IS FINE. THE ENDOTRACHEAL TUBE IS KINKED, WITH A TWIST IN IT. AT THE TIME OF REMOVAL, COULD NOT STRAIGHTEN. AFTER A PERIOD OF TIME, THE ENDOTRACHEAL TUBE STRAIGHTENED ITSELF.
EVALUATION: DEVICE WAS EVALUATED. CONFIRMED "KINK" IN TUBE FROM PHOTOGRAPHIC IMAGES FROM FACILITY. HOWEVER, TUBE WAS STRAIGHTENED WHEN RECEIVED. FROM PHOTOGRAPHS THE KINK APPEARS TO BE VERY CLOSE TO THE INLET OF THE PILOT VALVE (INFLATION LUMEN). UNDER NORMAL CIRCUMSTANCES, THIS PART OF THE DEVICE WOULD NOT BE IN THE "BACK OF THE PT'S MOUTH" AS INDICATED BY THE USER FACILITY. UNABLE TO DETERMINE EXACT CAUSE OF KINK AS SEEN BY THE USER FACILITY. IN ADDITION, THE TWIST AND KINK INDICATED BY THE USER FACILITY SUGGESTS THAT THE MALFUNCTION OCCURRED AS A RESULT OF USER-DEVICE TECHNIQUE OR OTHER ENVIROMENTAL CONTRIBUTING FACTORS. COULD NOT DUPLICATE THESE MALFUNCTIONS UNDER "NORMAL" SIMULATION OF FIELD PERFORMANCE. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? N. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? N. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT CO   DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT CO DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
A 61-YR-OLD MALE PT'S SERUM SAMPLE WAS TESTED THROUGHOUT THE YEAR USING THE CEA ASSAY. THE RESULTS ARE NOTED IN SECTION B6. AN ONCOSCINT SCAN WAS PERFORMED ON 8/23/96 WITH RESULTS OF ABNORMAL ACCUMULATION OF ONCOSCINT WITHIN LOWER MID AND MID LEFT ABDOMINAL REGIONS. THIS WOULD REPRESENT AN ACCUMULATION WITHIN LYMPH NODES AND POSSIBLY IN A LEFT ABDOMINAL MASS CONSISTENT WITH TUMOR METASTASIS. BASED ON THE ONCOSCINT SCAN RESULTS AN EXPLORATORY LAPAROTOMY WAS PERFORMED ON 9/5/96 WITH NEGATIVE NODE RESULTS. ADD'L CEA TESTS WERE PERFORMED AS FOLLOWS: 9/6/96 - ANOTHER CEA - 1.0NG/ML, 9/13/96 - CO CEA - 5.46NG/ML (SAMPLE RETURNED TO CO FOR TESTING), 9/19/96 - CO CEA (SAME SPECIMEN AS TESTED ON ANOTHER CO'S ANALYZER) 6.01 NG/ML, THE 9/13 SERUM SAMPLE WAS RETURNED TO CO FOR EVALUATION. SEE SECTION H-10. THE RETURNED SERUM SAMPLE WAS TESTED NEAT AND AFTER BEING SPIKED WITH A HETEROPHILE BLOCKING REAGENT USING AN IN-HOUSE CEA KIT LOT NUMBER 690971. RESULTS WERE AS FOLLOWS: NEAT=5.81 NG/ML, NEAT+HBR=<MDC (MINIMUM DETECTABLE CONCENTRATION). BASED ON THE ABOVE RESULTS, THE DATA INDICATE THAT THERE IS AN INTERFERING SUBSTANCE IN THE PT'S SERUM SAMPLE WHICH CAUSED A FALSELY ELEVATED RESULT WHEN USING THE CEA ASSAY KIT LOT NUMBER 690971.
THE SUBMISSION OF THIS MEDICAL DEVICE REPORT IS REQUIRED OF DEVICE MFRS BY 21 CFR PART 803. NEITHER THE SUBMISSION OF INFO BY CO PURSUANT TO THIS RULE, NOR THE PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CONNECTION BETWEEN THE PRODUCT AND ANY DEATH OR INJURY.
WHEN SURGEON DEPRESSED COAG, PENCIL REMAINED ON. NO PT INJURY.
EVALUATION SUMMARY: THE ACTUAL DEVICE WAS RETURNED AND EXAMINED. TESTING DUPLICATED THE PROBLEM. THE CAUSE OF THIS PROBLEM IS NOT KNOWN. THIS CORRECTION IS BEING SUBMITTED DUE TO A CLERICAL ERROR.
THE PT, A IDDM, AWOKE ON 9/24 FEELING DIZZY AND NAUSEATED. A BLOOD GLUCOSE RESULT ON HER METER WAS 57 MG/DL. SHE TOOK HER NORMAL DOSE OF INSULIN AND, BASED UPON THE METER READING, CONSUMED A COOKIE AND A COLA. SHE WENT FOR A REGULARLY SCHEDULED DR'S APPOINTMENT AT 10:15/A AND WAS LATER ADMITTED TO THE HOSPITAL WITH A LABORATORY BLOOD GLUCOSE RESULT OF >800 MG/DL. SHE WAS ADMITTED, TREATED WITH INSULIN AND RELEASED AT 8/P THE SAME DAY. THE METER IS NOT CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, ALCOHOL IS USED TO CLEAN THE METER OPTICS. ON 9/25, THE METER WAS IN CALIBRATION, READING 74 VERSUS A RANGE OF 64-85. A CONTROL SOLUTION RESULT ON THE TEST STRIPS WAS "21" (NO RANGE PROVIDED).
CO HAS COMPLETED ITS INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNK ANOMALY. AT THIS POINT CO'S INVESTIGATION OF THIS MATTER IS CLOSED.
CONTROL BOX MAIN PG8/70 P200. DEALER CLAIMS: THE CHAIR IS RUNNING BY ITSELF.
JOYSTICK DISPLACED DUE TO OUTSIDE CAUSE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA  THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CASTER HINGE R & L RV. DEALER CLAIMS CASTER HINGE BROKE OFF.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA  THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CUT AND COAG MODES DO NOT FUNCTION. OCCURS MOSTLY IN THE CUT MODE.
A QC RETAINED SAMPLE OF THE SAME LOT WAS TESTED. THE DEVICE WAS FOUND TO PERFORM AS INTENDED. THERE WAS NO EVIDENCE OF PRODUCT DEFECT.
THE PT, A IDDM, HAD THE FLU FOR SEVERAL DAYS PRIOR TO 9/24 AND WAS NOT FEELING WELL, HE AWOKE ON 9/24 FEELING "OUT OF IT." A FASTING RESULT (4:30/A) ON THE PT'S METER WAS 166 MG/DL. HIS WIFE TRANSPORTED HIM TO THE HOSPITAL WHERE A LAB BLOOD GLUCOSE RESULT (5:00/A) OF 1,022 MG/DL WAS OBTAINED. THE PT WAS ADMITTED FOR DIABETIC KETOACIDOSIS AND TREATED WITH SALINE AND INSULIN IV. THE PT REPORTS THAT HE REMOVES HIS TEST STRIPS FROM THEIR ORIGINAL VIAL AND PLACES THEM IN ANOTHER CONTAINER FOR CONVENIENCE. THE PRODUCT'S PACKAGE INSERT STATES TO KEEP THE TEST STRIPS IN THEIR ORIGINAL CONTAINER WITH THE VIAL TIGHTLY CAPPED. CALIBRATION STATUS IS UNK.
CO HAS COMPLETED THE INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER STORAGE OF TEST STRIP PRODUCT, OR SOME UNK ANOMALY. AT THIS POINT THE INVESTIGATION OF THIS MATTER IS CLOSED.
THE ACTUAL DEVICE WAS RETURNED TO CO AND TESTED. CO WAS UNABLE TO DUPLICATE THE REPORTED EVENT.
A SAMPLE WAS NOT SENT TO CO BY THE HOSPITAL. A WRITTEN REQUEST WAS SENT TO THE HOSPITAL DATED 11/08/96.
THE UNIT HAD A FREE FLOW ON ONE STATION. ACCORDING TO REPORTER, THE SET HAD BEEN INSTALLED PROPERLY. THE FINAL CONTAINER INVOLVED WAS NOT THE FIRST ONE COMPOUNDED. THE SET WAS CHANGED, BUT FREE FLOW CONTINUED FROM THE STATION, ALTHOUGH THE CALLER REPORTED THAT THE ROTORS WERE NOT LOOSE AND THE ROLLERS APPEARED TO BE IN PLACE. THE USER WAS ADVISED NOT TO USE THE UNIT, WHICH WAS SWAPPED OUT. NO PT INVOLVEMENT.
SECTION F WAS COMPLETED BY BAXTER, BASED ON INFO OBTAINED FROM REPORTER. EVAL: THE UNIT WAS REC'D DIRTY AND WAS TESTED AS REC'D IT PASSED IT ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
OPHTHALMOLOGIST REPORTS LENS WAS REPLACED DUE TO GLARE. HE REPORTS PT EXPERIENCED MARKED GLARE DAY AND NIGHT WHICH IMPROVED WITH THE USE OF PILOCARPINE. THE LENS WAS REPLACED WITH A 6MM PMMA LENS AND THE EVENT HAS RESOLVED.
THE LENS HAS NOT YET BEEN RETURNED TO THE MFR FOR EVALUATION. THIS REPORT WAS MAILED IN TO FDA ON: 10/30/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
PT ON INTRA-AORTIC BALLOON PUMP. 40CC INTRA-AORTIC BALLOON CATHETER HAS BEEN REPLACED AT APPROX 1335 ON 8/19/96 AFTER ORIGINAL BALLOON HAD RUPTURED. AT 0010 ON 8/20/96 SUDDEN BACKFLOW OF BLOOD NOTED WITH APPARENT RUPTURE OF BALLOON. PT HAD BEEN IN BED WITHOUT ANY SIGNIFICANT MOVEMENT. SURGEONS REPLACED BALLOON AT APPROX 0100.
PT WAS TESTED ON 5/2/96 AND 5/15/96 WITH NEGATIVE RESULTS. SHE WAS TREATED FOR THE FIRST TIME ON 6/26/96 TO THE FINE LINES ABOVE THE LIP, GLABELLA AND LEFT NASOLABIAL FOLD. ON 10/22/96, THE PT WAS SEEN IN FOLLOW UP. EDEMA AND ERYTHEMA WERE NOTED AT ALL SITES OF FACIAL TREATMENT AS WELL AS BOTH TEST SITES (ONSET UNK). THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY AND PRESCRIBED INTRAMUSCULAR KENALOG.
IN FOLLOW UP REPORTS FROM THE PHYSICIAN IT IS REPORTED THAT THE ETIOLOGY OF ALL SYSTEMIC SYMPTOMS WAS NEVER DETERMINED AND WOULD NOT BE DETERMINED. THE PT'S LOCAL SYMPTOMS CONTINUE. BECAUSE OF THE DURATION OF THE LOCAL SYMPTOMS THIS IS BEING REPORTED AS A PERMANENT INJURY.
DR REPORTS ORIGINAL IMPLANT SUBLUXATED CAUSING PIGMENT DISPERSION AND ELEVATED IOP. SHE REPORTS THAT THE ORIGINAL IMPLANT CHOSEN WAS THE WRONG POWER. THIS LENS WAS REMOVED ON 11/3/94 AND THE CORRECT POWER IMPOLANTED AND ALL PROBLEMS RESOLVED.
THE ORIGINAL COMPLAINT WAS RECEIVED ON 8/11/95 AND AT THAT TIME THE REPORTER INDICATED THE EVENT WAS NOT LENS RELATED. FOLLOW-UP INFO WAS REQUESTED AND FINALLY RECEIVED ON 9/30/96. AT THAT TIME THE DR REPORTED THAT ALTHOUGH THE WRONG LENS POWER WAS CHOSEN THE AE EXPEREIENCED WERE RELATED TO THE LENS AND ITS SUBLUXATION. A PKG WAS RETURNED TO THE MFR ON 8/24/95, HOWEVER THERE WAS NO INFO WITH THE BLOODIED LENS INSIDE THE PACKAGE TO INDICATE THIS WAS THE COMPLAINT LENS. THIS REPORT WAS MAILED IN  TO FDA ON: 10/29/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
ACCOUNT REPORTS SPORADIC INCIDENTS IN WHICH DEVICE NOTED TO BE "POPPING OUT OF IV CATHETERS WHEN USED IN NICU OR NURSERY UNIT. INCIDENTS OCCURRING WITH ANOTHER CO'S 24G CATHETERS AND DEVICE USED WITH PERIPHERAL, CENTRAL AND ARTERIAL LINES. NO KNOWN PT INJURIES REPORTED.
SECTION F COMPLETED BY BAXTER. NO OTHER INFO IS AVAILABLE. EVAL: CHARACTERISTIC SAMPLE NOT AVAILABLE AND SPEC LOT NUMBER NOT IDENTIFIED THEREFORE UNABLE TO FURTHER EVALUATE REPORT. THE SAFE AND EFFICACIOUS USE OF LUER SLIP ADAPTERS IS DEPENDENT ON A COMBINATION OF SPECIFIC MECHANICAL FORCES EMPLOYED DURING CLINICAL CONNECTION. ADEQUATE INSERTION FORCE APPROACHING AN OPTIMAL FIVE AXIAL POUNDS IN SIMULTANEOUS COMBINATION WITH A SLIGHT ROTATIONAL TWIST, 30 TO 45 DEGREES, OF THE ADAPTER IS RECOMMENDED IN ORDER TO ACHIEVE A STABLE AND LEAK FREE CONNECTION. IN ADDITION, THE USE OF A LUER LOCK DEVICE CONTINUES TO BE RECOMMENDED FOR CONNECTIONS TO CENTRAL AND ARTERIAL LINES OR IN CLINICAL APPLICATIONS REQUIRING A LOCKING MECHANISM DUE TO INTERNAL FORCES OR SIDE LOADS.
DURING A LAPAROSCOPIC OOPHERECTOMY. REPORTEDLY, THE BAG DISENGAGED FORM THE DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. THE SURGEON RETRIEVED THE BAG LAPAROSCOPICALLY AND COMPLETED THE PROCEDURE WITH ANOTHER DEVICE.
THE DISENGAGED COMPONENT WAS RETURNED FOR EVALUATION; HOWEVER, NO ABNORMALITIES WERE NOTED THAT WOULD HAVE CAUSED THIS CONDITION. FOR THIS REASON, WE COULD NOT RELIABLY DETERMINE THE EXACT CAUSE OF THE CONDITION REPORTED.
THE IAB WAS INSERTED ON 8/19/96 AT 1335. AT 0010 ON 8/20/96, THERE WAS A SUDDEN BACK-FLOW OF BLOOD INTO THE CATHETER. THE BALLOON HAD LEAKED. THE PT HAD BEEN IN BED WITHOUT ANY SIGNIFICANT MOVEMENT. THE IAB WAS REMOVED BY THE SURGEON AND ANOTHER WAS INSERTED AT 0100. CO WAS INFORMED OF THIS COMPLAINT VIA THE MANDATORY MEDWATCH FORM RECEIVED FROM THE USER FACILITY ON 8/23/96; UF/REPORT #: 1964000-1996-0007).
SINCE THE PRODUCT INVOLVED IN THIS EVENT WAS NOT RETURNED OR RELEASED TO CO FOR EVALUATION, NO ADD'L INFO CAN BE PROVIDED AND THE FILE WILL BE CLOSED. THIS FORM WAS COMPLETED BY THE MFR.
PT WAS TREATED INTO THE UPPER VERMILION BORDER ON 10/15/96. THE PHYSICIAN NOTICED UNUSUAL BRUISING AT THE RIGHT UPPER VERMILION BORDER IMMEDIATELY AFTER THE TREATMENT. THE PT WAS SEEN ON 10/16/96 WITH PERSISTENT BRUISING. ON 10/17/96, AN ULCERATION HAD DEVELOPED FROM THE BRUISED AREA APPROX. 0.75 INCH TOWARD THE RIGHT NOSTRIL. THE PHYSICIAN WAS UNSURE IF THE ULCERATION WAS RELATED TO HERPES AND PRESCRIBED ORAL DURICEF AND WARM COMPRESSES. ON 10/21/96, THE ULCERATION REMAINED; TOPICAL BACTROBAN WAS PRESCRIBED. ON 10/22/96, WARM COMPRESSES, LIGHT DEBRIDING OF THE AREA WAS PERFORMED AND THE PT WAS INSTRUCTED TO CONTINUE THE BACTROBAN.
NO INFO WAS RECEIVED FROM THE SIX MONTH FOLLOW UP. THE LAST INFO FROM THE PHYSICIAN RECEIVED 20 DECEMBER 1996 WAS THAT THE PT HAD A RESIDUAL SCAR AT THE LEFT UPPER LIP.
DR DECIDED TO PLACE A STENT. HE WENT DOWN WITH ANOTHER CO'S STENT TO LESION IN LAD. THE DEVICE WOULD NOT HOLD PRESSURE. DR. DECIDED TO TRY AND DEPLOY THE STENT BY CRANKING UP THE BALLOON AS FAST AS POSSIBLE. THE VESSEL BECAME DISSECTED AND BALLOON ON STENT BURST. DR TRIED TO USE THE CATHETER ON DISSECTION. PT WAS SENT TO SURGERY. AT THE END OF THE CASE THE DR PUT A STOPCOCK ON DEVICE AND IT HELD PRESSURE AT 8 AND 10 ATM.
THE DEVICE WAS RETURNED AND DECONTAMINATED PRIOR TO THE EVALUATION. A LEAK TEST WAS PERFORMED USING A CALIBRATED LEAK TESTER WHICH USES NITROGEN GAS. THE DEVICE WAS TESTED AT LOW, MEDIUM AND HIGH PRESSURES AND NO LEAKS WERE OBSERVED. THE DEVICE WAS ALSO CHECKED FOR PRESSURE LOSS AND LEAKING BY LEAK TESTING THE DEVICE AT THREE DIFFERENT LUER ROTATOR LOCATIONS USING A 50/50 CONTRAST MEDIA SOLUTION. AGAIN, NO LEAKS WERE OBSERVED AND PRESSURE LOSS WAS WITHIN SPECIFICATIONS.
PT UNDERGOING OPERATIVE PROCEDURE OF HAND (TENOLYSIS, TRANSPOSITION OF TENDONS AND RELEASE OF CONTRACTURES). DURING DISSECTION A 2-3 MM FRAGMENT OF THE SCISSORS TIPS ALLEGEDLY BROKE OFF IN THE WOUND. IT WAS ALLEGEDLY VISIBLE ON X-RAY TAKEN AT THE TIME. WOUND EXPLORATION WAS UNDERTAKEN IN AN EFFORT TO RETRIEVE THE ALLEGED FRAGMENT. HOWEVER, AFTER EXTENSIVE EFFORT, INCLUDING THE USE OF A MAGNET, THIS WAS NOT SUCCESSFUL. THEREFORE, PT HAS ALLEGEDLY RETAINED FOREIGN BODY IN THE WOUND. THE INSTRUMENT INVOLVED WAS REPORTEDLY APPROX 6 MONTHS OLD AT THE TIME.
CONTACT WITH THE UF HAS NOT YET BEEN POSSIBLE, TO GET THE DEVICE RETURNED AND OBTAIN FURTHER INFO.
THE INFUSION PUMP WAS REC'D AT CO'S SVC FACILITY WITH A VAGUE REPORT THAT THE PUMP "DELIVERS MORE THAN WHAT IT IS SET FOR". NO ADD'L INFO WAS REC'D. NO PT INJURY WAS REPORTED.
PT POSITIONED IN BED WITH DEVICE IN PLACE AND SET. DURING ROUTINE ASSESSMENT, PT FOUND INJURED ON THE FLOOR AT THE FOOT OF THE BED. THE ALARM HAD NOT SOUNDED. THE DEVICE WAS EVALUATED BY BIOMEDICAL DEPT WHO DISCOVERED A LOOSE WIRE FROM THE SONALERT TO THE PEGBOARD. SURGERY WAS REQUIRED TO SUTURE THE PT'S RIGHT LIP AND TO STRAIGHTEN AND WIRE TOOTH.
ONE OF THE BAGS COMPOUNDED WAS WEIGHED AND IT WAS DETERMINED TO BE 60 GMS HEAVIER THAN IT SHOULD HAVE BEEN. THERE WAS NO PT INVOLVEMENT. THE UNIT WILL BE RETURNED FOR EVAL.
SECTION F COMPLETED BY CO BASED ON INFO PROVIDED BY THE REPORTER. EVAL: THE UNIT WAS REC'D DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
THE DR REPORTED DETECTING PARTICLES COMING FROM THE PHACO TIP AND FLOWING INTO THE PT'S DURING A ROUTINE PHACOEMULSIFICATION PROCEDURE. THE PARTICLES WERE REMOVED AND THERE WAS NO HARM TO THE PT.
USER HAD 6 SOURCE CONTAINERS HUNG AND ONLY 3 OF THOSE SOLUTIONS WERE PROGRAMMED, HOWEVER THE HALF NORMAL SALINE SOLUTION WHICH WAS HUNG ON STATION #3 AND NOT PROGRAMMED, ENDED UP IN THE FINAL BAG. THIS WAS DETERMINED BY THE BAG VISUALLY APPEARING TO HAVE LESS SOLUTION IN IT THAN IT SHOULD HAVE. THERE WAS NO PT INVOLVEMENT AND THE UNIT WILL BE RETURNED FOR EVAL.
SECTION F COMPLETED BY BAXTER BASED ON INFO PROVIDED BY THE REPORTER. EVAL: THE UNIT WAS REC'D DIRTY AND WAS TESTED AS REC'D. UNIT PASSED ALL ACCURACY TESTS, HOWEVER FAILED ALARM CHECK STEP. THE COMPLAINT COULD NOT BE DUPLICATED.
THE DR REPORTEDLY DETECTED A METALLIC FOREIGN BODY IN THE PT'S EYE APPROX ONE WEEK FOLLOWING AN UNEVENTFUL PHACOEMULSIFICATION PROCEDURE. THE PT IS DOING FINE AND HAS NOT EXPERIENCED ANY COMPLICATIONS FROM THE PARTICLE. THE PRODUCT IS NOT BEING RETURNED FOR EVALUATION.
THE BALLOON MATERIAL DETACHED FROM THE CATHETER SHAFT DURING AN ARTERIOVENOUS HEMODIALYSIS FISTULA GRAFT DILATATION. FOLLOW UP INDICATED THE BALLOON WAS USED TO SUCCESSFULLY DILATE THE VENOUS SIDE AND WAS BEING ADVANCED FOR DILATATION OF THE ARTERIAL SITE WHEN THE BALLOON WOULD NOT INFLATE. DURING WITHDRAWAL OF THE BALLOON CATHETER, IT WAS NOTED APPROX 3/4 OF THE BALLOON MATERIAL HAD DETACHED IN THE PT. THE PT WAS SENT FOR GRAFT REVISION. THE BALLOON MATERIAL WAS RETRIEVED AT THE TIME OF SURGICAL GRAFT REVISION. NO PT SEQUELAE RESULTED FROM THIS EVENT AND THE PT'S CONDITION IS GOOD. CO'S FOLLOW UP INDICATED THE SHEATH USED DURING THIS PROCEDURE WAS DAMAGED. IT WAS ALSO INDICATED THE PT UNDERWENT GRAFT REVISION DUE TO THE NATURE OF THE BLOCKAGE AND NOT AS A RESULT OF THE DETACHED BALLOON MATERIAL. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE DISTAL PORTION OF THE BALLOON WAS MISSING AND WAS NOT RETURNED FOR EVALUATION. THE DISTAL BALLOON BOND WAS PRESENT AS WELL AS 2CM OF THE PROXIMAL BALLOON MATERIAL. THE INTRODUCER SHEATH USED DURING THIS PROCEDURE WAS ALSO RETURNED AND EVALUATED. THE DISTAL END OF THE SHEATH WAS FRAYED AND SLIGHTLY CRUSHED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LSION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VASSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. BASED ON CO'S FOLLOW UP INFO AND THE CONDITION OF THE DEVICES UPON RECEIPT AND EVALUATION, CO BELIEVES THE PT'S CONDITION CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE.
VENTRICULO PERITONEAL SHUNT PLACED ON 10/3/95 FOR HYDROCEPHALUS DUE TO ACQUEDUCTAL STENOSIS. REVISION OF THE SHUNT, CEPHALIC END, WAS FIRST PERFORMED ON 3/25/96 DUE TO PERSISTENT DILATION OF LATERAL AND THIRD VENTRICLES CAUSING HEADACHE AND BLURRED VISION CONFIRMED BY CT OF HEAD. A SECOND REVISION OF THE SHUNT, CEPHALIC END, WAS PERFORMED ON 9/14/96 DUE TO INEFFICIENT FLOW THROUGH THE VALVE, CONFIRMED BY SHUNT TAP. AGAIN, THE PT COMPLAINED OF HEADACHE AND BLURRED VISION. ADD'L CATALOG #: NL850 1431L.
CONSTANT COAGULATION ACTIVATION WHILE NOT DEPRESSING HAND OR FOOTSWITCH. NURSE CHANGED HAND SWITCHABLE ESU PENCIL AND EVERYTHING WAS FINE. X-RAYED SUSPECT PENCIL AND DISCOVERED METAL SHARD NEAR TWO OF THE SOLDERED LEADS INSIDE THE BODY OF THE PENCIL. PENCIL WAS PART OF ANOTHER CO'S CUSTOM STERILE PACK. PLUG STATES ANOTHER BRAND BUT BODY OF PENCIL HAS CO IMPRINTED ON IT.
THE USER CALLED REPORTING THAT SIX BAGS THEY RAN OVERDELIVERED BY 10%. THIS WAS DETERMINED BY WEIGHING THE FINAL CONTAINER OF SOLUTION. THERE WERE NO ALARM CONDITIONS AND NO PT INVOLVEMENT. THE UNIT WILL BE RETURNED FOR EVAL.
SECTION F COMPLETED BY BAXTER BASED ON INFO SUPPLIED BY THE REPORTER. EVAL: THE UNIT WAS REC'D DIRTY AND WAS TESTED AS REC'D. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
H3 END USER DID NOT RELEASE PRODUCT FOR MFR'S TESTING PURPOSES. H6 METHOD CODE 86, DEVICE HISTORY RECORDS REVIEWED. H6 CONCLUSION CODE 67, DEVICES WERE NOT RETURNED. NO CONCLUSION CAN BE DRAWN.
ANCHOR FOUND LOOSE AFTER STAMEY PROCEUDRE. THE ANCHOR WAS REMOVED IN A SECOND PROCEDURE. THE PT HAD DEVELOPED AND WAS TREATED FOR A BACTERIODED FRAGILIS INFECTION AT THE IMPLANT SITE.
LOT HISTORY SHOWS NBO VARIANCE IN STERILIZATION PROCESS.
INTRA-AORTIC BALLOON PUMP INITIATED ON 8/18/96 AT APPROX 1700. AT 1320 ON 8/19/96, BALLOON RUPTURED. SURGEON CALLED AND BALLOON REPLACED AT 1335. PT WAS IN BED. HAD BEEN REPOSITIONED WITHIN APPROX 30 MIN OF EVENT.
AN INFUSOR OVERINFUSED ITS CONTENTS OVER 18 OR 20 HOURS INSTEAD OF AN ANTICIPATED 24 HOURS. THE INFUSOR WAS FILLED TO A TOTAL VOLUME OF 48ML AND CONTAINED MORPHINE AND NORMAL SALINE. NO CLINICAL IMPLICATIONS REPORTED.
SECTION F WAS COMPLETED BY CO BASED ON INFO OBTAINED FROM THE CUSTOMER. EVAL SUMMARY. THE INFUSOR SAMPLE WAS REC'D AND TESTED BY RA/QA. THE SAMPLE FLOWED WITHIN PRODUCT FLOW RATE SPECS.
ANCHOR WAS SURGICALLY REMOVED AFTER THE PT DEVELOPED A SKIN RASH THE DR BELIEVED RELATED TO THE IMPLANT.
LABEL CONTAINS THE FOLLOWING WARNING: TITANIUM ALLOYS CONTAIN METALS WHICH MAY STIMULATE ALLERGIC HYPERSENSITIVE RESPONSE BY THE IMMUNE SYSTEM.
DURING A BOWEL RESECTION PROCEDURE, THE NEEDLE TIP BORKE. THE SURGEON RETRIEVED THE COMPONENT AND USED A NEW SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/25/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
PT WAS TREATED ON 3/8/96 WITH TWO FORMULATIONS OF COLLAGEN IN THE GLABELLA, NASOLABIAL FOLDS AND PERIORAL LINES. ON 4/19/96, THE PT REPORTED "LUMPINESS" AND "TENDERNESS" AT THE TREATMENT SITES (DATE OF ONSET UNK). ON 4/24/96, THE PT PRESENTED WITH FLESH-COLORED LUMPS AT THE PERIORAL TREATMENT SITES. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITIY; NO MEDICAL OR SURGICAL INTERVENTION WAS PRESCRIBED. ON 8/2/96, THE PT PRESENTED WITH CONTINUING SYMPTOMS; A LASER TREATMENT WAS PRESCRIBED.
CONSTANT COAGULATION ACTIVATION WHILE NOT DEPRESSING HAND OR FOOTSWITCH. NURSE CHANGED HAND SWITCHABLE PENCIL AND EVERYTHING WAS FINE.
MFG INFORMED AND CORRECTIVE ACTION HAS BEEN TAKEN. THE ACTUAL DEVICE WAS RETURNED TO CO AND TESTED. CO WAS UNABLE TO DUPLICATE THE REPORTED EVENT. HOWEVER, WHEN THE SUSPECT DEVICE WAS DISASSEMBLED A SMALL PIECE OF SOLDER DROSS WAS ON THE PRINTED CIRCUIT BOARD.
PT WAS TREATED ON 12/12/94 TO THE GLABELLA. A FEW HRS AFTER THE TREATMENT, THE PT DEVELOPED SWELLING, TENDERNESS AND BRUISING AT THE GLABELLA INJECTION SITE. OVER THE COURSE OF THE NEXT TWO TO THREE DAYS, SHE DEVELOPED CRUSTING AT THE SITE. THE PHYSICIAN PRESCRIBED CIPRO, IBUPROFEN AND TOPICAL NEOSPORIN (DATE UNAVAILABLE). HE BELIEVED THE SYMPTOMS REPRESENTED A VASOSPASM OR POSSIBLE NECROSIS. ON 3/30/95, THE PT WAS SEEN WITH SLIGHT ERYTHEMA AND NO CONTOUR IRREGUARITY OR SCARRING AT THE GLABELLA. HE HAD NOT SEEN THE PT SINCE 3/30/95.
COMMENT ON RETURNED CLINICAL REPORT FORM: LOST FOLLOW-UP IN 3/95. PT DID NOT COME IN FOR EVALUATION. HAS NOT BEEN SEEN SINCE INJECTION DATE. DATA UPDATED: PT FIRST SKIN TESTED 8/90. INDICATION FOR TREATMENT FROWN LINES. CAUSALITY: PROBABLY. NECROSIS AT INJECTION SITE.
THE IAB WAS INSERTED ON 8/19/96 AT 1700. AT 1320 ON 8/19/96, THE BALLOON LEAKED. THE SURGEON WAS CALLED AND THE IAB WAS REMOVED AND REPLACED. THE PT WAS IN BED AND HAD BEEN REPOSITIONED APPROX 30 MINUTES BEFORE THE EVENT OCCURRED. CO WAS INFORMED OF THIS COMPLAINT VIA THE MANDATORY MEDWATCH FORM RECEIVED FROM THE USER FACILITY ON 8/23/96; UF/REPORT #: 196400-1996-0006).
CUT MODE ALWAYS ACTIVATED WITHOUT BEING KEYED BY EITHER HANDPIECE OR FOOTSWITCH. PUSHING SWITCH ON HANDPIECE WOULD DEACTIVATE THE DEVICE BUT WOULD REACTIVATE WHEN SWITCH WAS RELEASED.
SECTION F WAS COMPLETED BY CO BASED ON INFO OBTAINED FROM THE CUSTOMER. EVAL SUMMARY: THE INFUSOR SAMPLE WAS REC'D AND TESTED BY CO RA/QA. THE SAMPLE FLOWED WITHIN PRODUCT FLOW RATE SPECS.
DURING AN UNSPECIFIED PROCEDURE, REPORTEDLY, THE SUTURE BROKE AS KNOTS WERE BEING TIED. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PT WAS TREATED ON 3/8/96 IN THE GLABELLA AND NASOLABIAL FOLDS. ON 3/15/96, THE PT NOTED AND PRESENTED WITH ERYTHEMA, SWELLING, INDURATION, AND PRURITIS AT THE GLABELLAR TREATMENT SITE. THE PHYSICIAN DIAGNOSED A POSSIBLE HYPERSENSITIVITY; NO MEDICAL OR SURGICAL INTERVENTION WAS PRESCRIBED OR PLANNED. A FOLLOW UP CALL ON 10/23/96 REVEALED THAT THE PT WAS SEEN WITH "LUMPINESS" AT THE GLABELLA TREATMENT SITE; THE PHYSICIAN PRESCRIBED INTRALESIONAL KENALOG (DATE UNK). ON 10/23/96, THE "LUMPINESS" PERSISITED.
PHYSICIAN INSERTED CATHETER INTO BODY, HOWEVER HE COULDN'T CONFIRM THE PLATINUM MARKER UNDER THE FLUOROSCOPY. HE ADVANCED THE CATHETER A LITTLE, THEN THE DISTAL TIP DAMAGED THE WALL OF VESSEL AND SPASM OCCURRED." HE SUBSEQUENTLY PULLED THE CATHETER OUT OF THE BODY AND HE FOUND THE DISTAL CLEAR SHAFT MISSING. HE DID NOT NOTICE THE SHAFT HAD RIPPED WHEN HE REMOVED THE PROTECTIVE SHEATH.
CATHETER WAS RETURNED AND ANALYZED FOR FAILURE MODE. THE PACKAGING SHEATH WITH THE DETACHED SEGMENT WAS NOT RETURNED. DURING THE ANALYSIS, IT WAS CONFIRMED THAT THE DISTAL SHAFT WAS MISSING, HAVING DETACHED WITH A CLEAN CIRCUMFERENTIAL FRACTURE AT THE JUNCTION TO THE MID SHAFT. IT HAS BEEN OBSERVED THAT THE PROTECTIVE PACKAGING SHEATH HAS A STICKY CHARACTERTISTIC WHICH, WHEN COMBINED WITH COATING, AND ETO STERILIZATION, MAY ADHERE TO THE CATHETER. THIS CAN CAUSE FRACTURE OF THE CATHETER WHEN THE SHEATH IS REMOVED. HOWEVER, THE PACKAGE INSERT STATES: THE CATHETER WITH PRE-INSERTED GUIDEWIRE IS PACKAGFED INSIDE A PROTECTIVE TRAY. ONCE OPENED, CAREFULLY REMOVE PROTECTIVE SHEATH (30 CM) FROM DISTAL END; INSPECT. THE SHEATH IS NOT INTENDED FOR USE INSIDE THE BODY. WARNING: DO NOT USE A CATHETER OR GUIDEWIRE THAT HAS BEEN DAMAGED IN ANY WAY. DAMAGED CATHETERS MAY RUPTURE CAUSING VESSEL TRAUMA. A NEW PACKAGING CONFIGURATION THAT WILL NOT USE THE PINK SHEATH TO PROTECT THE GUIDEWIRE IS BEING VALIDATED. THE MOST PROBABLE CAUSE FOR THE FAILURE OF THE DEVICE COULD BE RELATED TO THE STICKESS OF THE PINK SHEATH WHICH REQUIRED THE USE OF EXCESSIVE TENSILE FORCES IN ORDER TO REMOVE THE CATHETER FROM ITS PROTECTIVE SHEATH. THIS INFO IS BASED ON INFO SUPPLIED TO CO WITHOUT ITS INDEPENDENT VERIFICATIONS AS TO ITS ACCURACY, COMPETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT.
CUT MODE ALWAYS ACTIVATED WITHOUT BEING KEYED BY EITHER HANDPIECE OR FOOTSWITCH. PUSHING SWITCH ON HANDPIECE WOULD DEACTIVATE THE ESU BUT WOULD REACTIVATE WHEN SWITCH WAS RELEASED.
USER FACILITY EVALUATED THE SUSPECT DEVICE (DESTRUCTIVE TEST). CO BELIEVES THAT THE ABOVE EVALUATION CODES APPLY TO THEIR EXAMINATION. MFG HAS BEEN INFORMED AND CORRECTIVE ACTION TAKEN.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, PNEUMOPERITONEUM LEAKED FORM THE INSTRUMENT.
THE INFUSION PUMP REC'D AT SVC FACILITY WITH A VAGUE REPORT OF THE PUMP BEING INACCURATE. NO ADD'L INFO WAS ABLE TO BE REC'D. NO PT INJURY WAS REPORTED.
SECTION F10 COMPLETED BY THE MFR. EVAL SUMMARY. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPEC.
CO RECEIVED INFO THAT THIS LEAD WAS REPAIRED. DURING A ROUTINE REPLACEMENT PROCEDURE THE PHYSICIAN NOTED THIS LEAD HAD AN INSULATION BREAK AT THE PROXIMAL END. THE LEAD WAS REPAIRED WITH MEDICAL ADHESIVE AND A SLEEVE. CO IS UNABLE TO CONFIRM THE SERIAL NUMBER OF THE REPAIRED LEAD, BOTH LEADS ARE REPORTED ON THIS REPORT. IMPLANTED 12/08/92. REMAINS IMPLANTED.
THE LEAD REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVAILABLE INFO ON THE ALLEGED LOW IMPEDANCE. NO FURTHER INFO IS AVAILABLE.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. IT WAS REPORTED BY THE REP THE SURGEON COULD NEITHER STAPLE OR CUT. SAME RESULT OCCURRED AFTER HE HAD CHANGED THE CARTRIDGE. THE SURGEON FINISHED THE PROCEDURE BY USING A NEW INSTRUMENT. DR. HAD TO EXTEND INCISON. RELOAD CARTRIDGE ALSO BEING RETURNED.
D5;H4: INFORMATION NOT PROVIDED BY AFFILIATE. H6; EVALUATION CODE #400(OTHER): DAMAGED FIRING MECHANISM.
DURING A LAPAROSCOPIC FALAOPY PROCEDURE, PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PT ADMITTED FOR GUNSHOT WOUND TO CHEST - DURING POST-OP COURSE IN INTESIVE CARE UNIT - HIS VENTILATOR MALFUNCTIONED AND COMPLETELY SHUT DOWN - PT WAS MANUALLY VENTILATED WITH AMBU BAG UNTIL NEW VENTILATOR WAS OBTAINED - OXYGEN SATS REMAINED AT 99% - NO COMPLICATIONS TO PT FROM THIS EVENT.
ALLEGED SYMPTOMS OF AUTOIMMUNE DISEASE AND RUPTURE. FOLLOW-UP FINDINGS: REPORT IS NOT SUBSTANTIATED BY A HEALTH PROFESSIONAL. OUTCOME UNDETERMINED. REPORT SENT '93 USP - SECTION OF TISSUE EXPOSED (SILICONE) REMOVED 8/86. REPLACEMENT SILICONE FILLED IMPLANTS SET OF PROBLEMS/SYMPTOMS IN '91. CHEST WALL PAIN ESP. ON CHEST. EARLY EVIDENCE OF SIDE DEFORMITY OF CHEST WALL. RUPTURE MUSCLE AND JOINT PAINS - ALL EXTREMITIES CHRONIC FATIGUE. PANIC DISORDERS - HOSP ADMISSION 9/92 FOR PSYCHIATRIC CARE & ELECTRIC SHOCK THERAPY. SYMPTOMS (ABOVE) CONTINUED TO WORSEN INCLUDING DEPRESSION. IMPLANTS REMOVED 3/17/95 - RUPTURED. REMOVAL OF GRANULOMAS FROM INCISION, MUSCLE ACHES & PAINS WORSEN AREA 8/16/95. RHEUMATOLOGY CONSULT - FIBROMYALGIA - SILICONE RELATED DISORDER.
THE POTENTIAL FOR THE ABOVE-NOTED EVENTS TO OCCUR IS ADDRESSED AND /OR ANTICIPATED IN THE LABELING. AS PER 21CFR803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. MCGHAN MEDICAL DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVAL CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF MMC'S EVAL OF THE DEVICE. MCGHAN MEDICAL'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. FILING A MDR DOES NOT CONSTITUTE AN ADMISSION BY MMC THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. REPORTS ARE BASED ON INFO SUPPLIED TO MCGHAN MEDICAL AND THE SUBSEQUENT INVESTIGATION. CO CONSIDER THIS INFO TO BE HIGHLY CONFIDENTIAL AND, THEREFORE, REQUEST THAT YOU PROTECT IT FROM ANY REQUEST, PURSUANT TO 21CFR PART 803.9(B).
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC HERNIA PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
INFANT RADIANT WARMER IN SERVO (SKIN TEMPERATURE) CONTROL CONTINUED TO HEATER A HIGH SET TEMPERATURE ALARM ACTIVATED. A WARMER DISPLAY TEMPERTURE OF 44 DEGREES CENTIGRADE WAS OBSERVED. IT HAS BEEN INDICATED THAT THE INFANT HAS BEEN RELEASED FROM THE HOSP, WITHOUT THE NEED FOR MEDICAL INTERVENTION, OR SUSTAINING A SERIOUS INJURY RELATING TO THIS EVENT REPORT.
THE HIGH SET TEMPERATURE ALARM THAT WAS REPORTED TO HAVE ACTIVATED OCCURS WHEN THE SENSED SKIN TEMPERATURE EXCEEDS THE SELECTED CONTROL TEMPERATURE BY 0.5 DEGREES CENTIGRADE. DURING THIS ALARM CONDITION THE HEATER WOULD BE TURNED OFF. A SOLID STATE RELAY WHICH CONTROLS HEATER POWER DURING OPERATION WOULD OPEN TO CAUSE HEATER POWER TO BE DISCONTINUED. ADDITIONALLY, AT THE SAME TIME A REDUNDANT MECHANICAL SAFETY RELAY CIRCUIT WILL OPEN TO DISCONNECT HEATER POWER FROM ITS SUPPLY VOLTAGE. SVC ENGINEER VISITED THE HOSP AND PERFORMED A CALIBRATION AND PERFORMANCE CHECK OUT OF THE WARMER. SOME MINOR OUT OF CALIBRATION CONDITIONS WERE IDENTIFIED BUT THEY WOULD NOT ACCOUNT FOR THE REPORTED CIRCUMSTANCES OF THIS EVENT. BOTH THE SOLID STATE HEATER CONTROL AND SAFETY BACK UP RELAYS WERE FOUND TO BE PERFORMING NORMALLY. THIS SECTION PROVIDES THE EVAL SUMMARY REQUESTED IN BLOCK H.3.
DURING A LAPAROSCOPIC FALAOPY PROCEDURE, PNEUMOPERITONEUM LEAKED FORM THE INSTRUMENT. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PT ADMITTED FOR GSW TO CHEST, DURING POST-OP COURSE IN THE INTENSIVE CARE UNIT, HIS VENTILATOR MALFUNCTIONED AND COMPLETELY SHUT DOWN. THE PT WAS MANUALLY VENTILATED WITH A AMBU-BAG UNTIL A NEW VENTILATOR WAS OBTAINED. THE OXYGEN SATURATION REMAINED AT 99%, NO COMPLICATIONS TO PT FROM THIS EVENT.
THE VENTILATOR WAS INSPECTED ON 2/8/96 BY THE USERS FACILITY. THE EVENT AS DESCRIBED IN THE USER REPORT COULD NOT BE DUPLICATED. THE VENTILATOR WAS PLACED BACK INTO SVC, WITHOUT ANY FURTHER REPORTS SINCE 2/8/96.
PER THE INFO PROVIDED TO CO THROUGH MEANS OF THE PHYSICIAN/SURGEON'S OPERATIVE REPORT, THE DEVICE WAS REMOVED DUE TO "LEAKAGE." AS STATED BY THE PHYSICIAN, "THE CYLINDERS WERE FOUND TO BE INTACT AND WHEN THE TUBING FROM THE PUMP TO THE RESERVOIR WAS IRRIGATED FOUND TO HAVE A LEAK AT THE JUNCTION OF THE TUBING WITH THE RESERVIOR." THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH CO'S 3-PIECE INFLATABLE PENILE PROSTHESIS."
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 5/5/1994 AND REMOVED ON 9/17/1996 DUE TO "LEAKAGE." IN THE RECEIVED INFO THE PHYSICIAN STATED "AND WHEN THE TUBING FROM THE PUMP TO THE RESERVOIR WAS IRRIGATED WAS FOUND TO HAVE A LEAK AT THE JUNCTION OF THE TUBING WITH THE RESERVOIR." QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PRECLUDED FROM COMMENTING ON THE CONDITION OF THE PROSTHESIS. SHOULD THE EXPLANTED DEVICE BECOME AVAILABLE, OR ADDITIONAL INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES.
CUSTOMER CLAIMS UNIT FOLDED. NO INJURIES WERE REPORTED.
RE H-3 (81, OTHER) UNIT TO BE EVALUATED BY AN INDEPENDENT SVC AGENT.
THE DEVICE WAS APPLIED DURING A RIGHT HEMI-COLECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
10/25/96-MEDWATCH REPORT NOT RECEIVED BY MFR, SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
DURING A LAPAROSOCPIC REMOVAL OF AN OVARIAN CYST. THE SAFETY SHIELD DID NOT RETRACT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/23/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
A BALLOON RUPTURED AND DETACHED UPON WITHDRAWAL FOLLOWING THE FOURTH INFLATION DURING AN ILIAC ANGIOPLASTY OF A HIGHLY CALCIFIED LESION VIA AN IPSILATERAL APPROACH. THE AREA WHERE THE BALLOON DETACHED WAS STENTED HOWEVER, THE BALLOON MATERIAL COULD NOT BE LOCATED. THE PT WAS SENT TO SURGERY THE FOLLOWING DAY FOR SEVERAL VASCULAR RELATED ISSUES UNRELATED TO THIS PROCEDURE. THIS DEVICE WAS NOT RETURNED FOR EVAL. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. CO FOLLOW UP INDICATED THE LESION WAS HIGIHLY CALCIFIED AND REQUIRED STENTING. CO BELIEVES THE PT'S CONDITION CONTRIBUTED TO THIS EVENT AND DID NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE PRODUCT, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
THE INFO SUPPLIED IN SECTION F ON THIS MEDWATCH REPORT HAS BEEN PROVIDED BY THE MFR. SEE ATTACHED UFR.
THE DEVICE WAS APPLIED DURING A RIGHT HEMI-COLECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING REWARMING, WHEN THE CROSS CLAMP WAS REMOVED, THERE WAS NO FORWARD FLOW FROM THE PUMP DESPITE NORMAL RPM'S. THE PUMP DESPITE NORMAL RPM'S. THE VENOUS RESERVOIR WAS FULL. FLOW WOULD MOMENTARILY RETURN WHEN THE ARTERIAL LINE WAS MANIPULATED, BUT COULD NOT BE SUSTAINED. THE ARTERIAL LINE WAS SWITCHED TO A ROLLER HEAD FOR THE REMINDER OF THE CASE, WHICH WAS UNEVENTFUL. PT IS DOING WELL.
PER THE INFO PROVIDED TO CO BY PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO "EROSION." IT WAS ALSO STATED THAT A CONTRIBUTING FACTOR TO THIS EVENT MAY HAVE BEEN OCCURRED AS THE "PT KEPT THE DEVICE INFLATED CONTINUALLY." AS REPORTED TO CO THE ENTIRE DEVICE WAS REMOVED AND IT IS NOT KNOWN IF IT WAS REPLACED.
REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. HOWEVER, BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF EROSION, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION, AND CONCLUDES THAT THE DEVICE BEING CONTINUALLY INFLATED MAY HAVE CONTRIBUTED TO THIS OCCURRENCE. IN ADDITION, BECAUSE THERE IS NO APPARENT IMPLANT HISTORY FOR THIS PT RECORDED BY THE MFR, AND THE DEVICE WAS NOT RECEIVED, QA IS PRECLUDED FROM CONFIRMING THE DEVICE REFERENCED AS MFG BY THIS CORP.
IT WAS REPORTED A BALLOON DEVELOPED A LEAK ON THE FIRST INFLATION AT EIGHT ATM DURING A LEFT RENAL ANGIOPLASTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. SINCE CO FOLLOW UP INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION, CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO DIRECTIONS FOR USE STATE: "DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON, BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
THE DEVICE WAS APPLIED DURING A PROSTATECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
CO RECEIVED INFO THAT THIS LEAD WAS REPAIRED. DURING THE ROUTINE REPLACEMENT PROCEDURE THE PHYSICIAN NOTED THIS LEAD HAD AN INSULATION BREAK AT THE PROXIMAL END. THE LEAD WAS REPLACED WITH MEDICAL ADHESIVE AND A SLEEVE. CO IS UNABLE TO CONFIRM THE SERIAL NUMBER OF THE REPAIRED LEAD, BOTH LEADS ARE REPORTED ON THIS REPORT. IMPLANTED 12/08/92. REMAINS IMPLANTED.
DURING AN AORTIC GRAFT TO ILIAC ARTERY. THE SUTURE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
D5,6; H4: INFO UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION.
9/25/96 DR CONFIRMED THE INFO AS REPORTED BY THE REP. ONCE INSERTED, THE BALLOON WOULD NOT INFLATE DESPITE ATTEMPTS AT PUMPING IT. DR STATED THERE WERE NO ADHESIONS IN THE PLANE OF DISSECTION. SALINE WAS USED TO LUBRICATE THE INSTRUMENT AND THE SCOPE. THE SCOPE WAS USED DURING TUNNELING. WHEN THE INSTRUMENT WAS REMOVED, A SMALL HOLE WAS SEEN IN THE BALLOON. NO FRAGMENTS BROKE OFF AND NO PIECES WERE LEFT IN THE PT. TSB
THE DEVICE WAS USED DURING A PROSTATECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
PER THE INFO PROVIDED TO CO BY THE HOSP, THE DEVICE WAS REMOVED DUE TO AN "INFECTED PROSTHESIS." AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED.
EXAMINATION AND TESTING OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION. THEREFORE QA ACCEPTS THE PHYSICIAN'S DIAGNOSIS OF THIS AS THE CAUSE FOR REVISION. ALL DEVICES RELEASED AS STERILE MUST PASS MFG AND QC CRITERIA FOR STERILIZATION PRIOR TO RELEASE. BASED ON THIS INFO QA CONCLUDES THE INFECTION INITIATED FROM A SOURCE OF SOURCES OTHER THAN THE DEVICE.
THE CUSTOMER RETURNED THE 550 VENTILATOR FOR EVALUATION. DURING CO FUNCTIONAL TEST, ENOUGH LIQUID OXYGEN LEAKED FROM THE BLOWN DIAPHRAGM IN THE RELIEF ECONOMIZER VALVE DURING AND AFTER FILL TO POTENTIALLY CAUSE A SERIOUS INJURY SHOULD THIS MALFUNCTION RECUR. CO SVC TECH ALSO REPORTED THAT THE QUICK CONNECT AND SECONDARY RELIEF VALVE LEAKED, THE FEMALE ADAPTOR WAS CRACKED, AND THE VENT VALVE WAS CORRODED. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MFG PROCESS PER THE APPROVED DMR. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED ON UNITS MFG AFTER 11/22/94 WHICH REPLACED THE RELIEF ECONOMIZER VALVE DIAPHRAGM WITH A MORE DURABLE MATERIAL.
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
THE DISPOSABLE LOADING UNIT WAS USED WITH AN STAINLESS STEEL INSTRUMENT DURING A SUB-TOTAL GASTRECTOMY. REPORTEDLY, THE STAPLES DID NOT RELEASE FROM THE CARTRIDGE. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
PER THE INFO PROVIDED TO CO BY PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO A "TUBING BREAK." IT WAS REPORTED THAT THE PT WAS INITIALLY IMPLANTED ON 12/16/91; A REVISION WAS PERFORMED ON 4/1/94, MDR REPORT ACCESS #491229 WHEREBY THE PUMP, CYLINDER(S) AND CONNECTOR(S) ONLY WERE REMOVED AND REPLACED. THIS LEFT THE RESERVOIR COMPONENT REMAINING IN PLACE SINCE INITIAL IMPLANT ON 12/16/91.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 4/1/94 AND REVISED ON 10/1/96 DUE TO A "TUBING BREAK." REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES.
IT WAS NOTED IMMEDIATELY POST-LAPROSCOPIC CHOLECYSTECTOMY THAT THE TIP OF THE LAPROSCOPIC GRASPER HAD BROKEN OFF. PT X-RAYED, AND X-RAY SHOWED FAINTLY DECERNABLE SIMILARLY SHAPED SHADOW. AT THE TIME A DECISION WAS REACHED NOT TO RETRIEVE THIS TIP OF THE LAPROSCOPIC GRASPER.
REPORTER STATED, REVISION SURGERY REVEALED LOOSENING OF THE BASEPLATE. DURING THE SURGERY, THE TIBIAL INSERTS WOULD NOT SEAT PROPERLY IN THE REVISION BASEPLATE. A NEW BASEPLATE AND INSERT WERE CHOSEN AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
SUMMARY OF EVAL: THE TIBIAL BASEPLATE AND TIBIAL INSERTS WERE VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE BASEPLATE IS IN NEW CONDITION. THE ANTERIOR LOCKING TAB OF EACH OF THE INSERTS EXHIBITS INSIGNIFICANT DISTORTION AS A RESULT OF THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. A DIMENSIONALY INSPECTION OF THE BASEPLATE FOUND THAT ALL DIMENSIONS RELATING TO INSERT MATING MET DESIGN REQUIREMENTS. THE INSERTS WERE ASSEMBLED IN THE AS-RECEIVED CONDITION TO THE RETURNED BASEPLATE USING TWO-THUMBS PRESSURE. RESULTS FOR ALL THREE INSERTS WERE A CRISP SNAP ACTION WITH FULL, TIGHT SEATING. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS BASEPLATE AND INSERTS FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MANUFACTURE. THE EVAL RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES.
THE DEVICE WAS APPLIED DURING A SUB-TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
ALLEGED SYMPTOMS OF AUTOIMMUNE DISEASE AND RUPTURE. FOLLOW-UP FINDINGS: REPORT IS NOT SUBSTANTIATED BY A HEALTH PROFESSIONAL. OUTCOME: UNDETERMINED.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21CFR803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. MCGHAN MEDICAL DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVAL CODES ARE NECESSARILY, AN ACCURATE REFLECTION OF MMC'S EVAL OF THE DEVICE. MCGHAN MEDICAL'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. FILING A MDR DOES NOT CONSTITUTE AN ADMISSION BY MMC THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. REPORTS ARE BASED ON INFO SUPPLIED TO MCGHAN MEDICAL AND THE SUBSEQUENT INVESTIGATION. CO CONSIDERS THIS INFO TO BE HIGHLY CONFIDENTIAL AND, THEREFORE, REQUESTS THAT YOU PROTECT IT FROM ANY REQUEST PURSUANT TO 21CFR803.9 (B).
DR REPORTED THAT AN IMPLANT FAILED DUE TO INFECTION AND LONG TERM OVERLOADING. PT IS REPORTEDLY FINE. PT IS SAME PT AS MDR REPORT #M494297 AND M763859.
THE DEVICE WAS USED WITH DISPOSABLE STAPLER DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTRECTOMY PROCEDURE. REPORTEDLY, THE CARTRIDGE DID NOT FIRE COMPLETELY. THE SURGEON RELOADED THE INSTRUMENT AND COMPLETED THE PROCEDURE WITHOUT INCIDENT.
REPORTER STATED, THE TIBIAL INSERT WOULD NOT FIT PROPERLY IN THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE EVENT WAS CAUSED BY A 45 DEGREE CHAMFER MISSING FROM THE SNAP TAB. THE MFG AND INSPECTION CRITERIA HAVE BEEN CHANGED THEREBY PREVENTING ACCEPTANCE OF PRODUCT WITHOUT THE 45 DEGREE CHAMFER.
THE DEVICE WAS USED DURING A LAPAROSCOPIC COLON PROCEDURE. IT WAS REPORTED THE DEVICE WOULD NOT ENGAGE. THERE WAS NO CONSEQUENCE TO THE PT. 9/25/96, REP REPORTS A SECOND OBTURATOR WAS INTRODUCED AND USED SUCCESSFULLY WITH THE ORIGINAL DEVICE SLEEVE.
D6-INFORMATION UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS DETERMINED THAT THE INSTRUMENT ARMED INTERMITTENTLY. THE INSTRUMENT'S ENDCAP WAS DISASSEMBLED AND THE KNIFE COLLAR FOUND TO BE BENT WHICH MAY HAVE CAUSED THE REPORTED INCIDENT. NO CONCLUSION COULD BE REACHED AS TO HOW THE KNIFE COLLAR HAD BECOME BENT. COMMENTS: CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE PRODUCTS. THE ASSEMBLY LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
IT WAS NOTED IMMEDIATELY POST-LAPAROSCOPIC CHOLECYSTECTOMY THAT THE TIP OF THE LAPAROSCOPIC GRASPER HAD BROKEN OFF. PT X-RAYED AND X-RAY SHOWED FAINTLY DECERNABLE SIMILARLY SHAPED SHADOW. AT THE TIME A DECISION WAS REACHED NOT TO RETRIEVE THIS TIP OF THE LAPAROSCOPIC GRASPER.
THE LABELING FOR THIS INSTRUMENT STATES THAT AFTER ONE YEAR. THE INSTRUMENT IS DEEMED NON-SERVICEABLE AND REPLACEMENT IS RECOMMENDED. THE INSTRUMENT INVOLVED IN THIS INCIDENT WAS SHIPPED TO THE CUSTOMER IN 2/95 AND IS MORE THAN ONE AND ONE HALF YEARS OLD. A COPY OF THE PACKAGE INCLUDED. THE CUSTOMER REFUSES TO RETURN THE INSTRUMENT TO CO FOR EVAL.
THE DEVICE WAS APPLIED DURING A COLECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
PT CAME IN WITH CROWN IN HAND, UPON REMOVAL DR FOUND THAT THE SCREW WAS BROKEN. PT IS REPORTEDLY FINE.
DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, THE INSTRUMENT EJECTED CLIPS PREMATURELY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
BONE CEMENT ALLEGEDLY SET UP FASTER THAN EXPECTED REQUIRING FURTHER SURGICAL INTERVENTION.
EVAL CODES FOR SECTION H6: 86-100. 86 -DEVICE WAS NOT RETURNED FOR EVAL. 100 - THE LAB RESULTS AT THE TIME OF MFG FOR THIS LOT MET REQUIREMENTS. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OF GREATER SEVERITY THAN IS USUAL FOR PRODUCT? UNK.
LOCATED IN SITE #19 AREA SINGLE FREE STANDING. PT SAID SHE FELT LOOSENESS AND CAME TO SEE THE DR. THE DR SAW THAT THE RETAINING SCREW WAS BROKEN.
DURING AN OPEN HEART PROCEDURE, THE CLIPS DID NOT ADVANCE PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DEVICE WAS BEING USED IN SHOULDER SURGERY AND DEVICE SPLIT IN HALF DURING INSERTION.
CONTACT REPORTED THAT DEVICE WAS RETRIEVED WITH A SHORT SURGICAL DELAY. NO PT INJURY WAS REPORTED. CO DISCLAIMER: CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT."
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. THE STAPLER FIRED 3 TIMES BEFORE JAMMING. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAM AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "ONLY FIIRED 3 TIMES BEFORE JAMMING" DURING SURGERY MAY HAVE BEEN DUE TO A TWISTED STAPLE IN THE CARTRIDGE NOSE WHICH CAUSED THE INSTRUMENT TO JAM. THE INSTRUMENT WAS RECEIVED WITH A TWISTED STAPLE JAMMED IN THE CARTRIDGE NOSE, WHICH WAS REMOVED AND THE INSTRUMENT WAS CYCLED AND FIRED THE REMAINING 20 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO HOW THE STAPPLE HAD BECOME TWISTED AND JAMMED IN THE CARTRIDGE NOSE. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. THE INSTRUMENT'S STAPLES MAY BECOME TWISTED WITHIN THE CARTRIDGE TRACK AND NOSE IF THE INSTRUMENT SUSTAINS A BLUNT TRAUMA.
X-RAYS REVEALED PIVOT PIN WAS BACKING OUT. DURING REVISION THE POLY BUSHINGS WERE FOUND DAMAGED AND BROKEN. THE BUSHINGS AND PIVOT PIN WERE REMOVED AND REPLACED.
OTHER DEVICES USED: CATALOG #32-8105-012-00 ULNAR ASSEMBLY LOT #34427500. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK.
SEEMS THAT ONE OF THE SCREWS WAS LOOSE OR BROKE AND THE PT CONTINUED TO HAVE NORMAL MASTICATION TO THE POINT WHERE THE DISTAL SCREW BROKE. LOCATED IN THE LOWER RIGHT AREA. THE BRIDGE WAS BROKEN BUT STILL LOADED ON THE IMPLANT.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT EJECTED UNFORMED CLIPS PREMATURELY. THE HOSP HAS REPORTED NO FURTHER INFO.
10/25/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA BY MFG. ADDITIONAL DATA SUBMITTED FOR D9. DEVICE EVALUATION INDICATED AND CODE ENTERRED IN H3 AND H6.
THE REPORTER INDICATED THAT THE DEVICE HAD NO OUTPUT.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. A.4 WEIGHT IS UNK PER PT'S PHYSICIAN
REPORTED STATED, THE TIBIAL INSERT WOULD NOT FIT PEROPERLY IN THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
H4: MFR. DATE = 11/00/95. THE INSERT COULD NOT BE SNAPPED INTO POSITION BECAUSE OF THE DEFORMED SNAP TAB. THIS DAMAGE IS CONSISTENT WITH DOWNWARDS FORCE BEING APPLIED TO THE INSERT BEFORE IT IS SUFFICIENTLY FAR BACK TO ENGAGE CORRECTLY WITH THE POSTERIOR RETAINING FLANGES OF THE BASEPLATE.
DEVICE WAS RETURNED FOR REPAIR WITH INNER TIP MISSING.
EVALUATION REVEALED DULL EDGES ON THE DEVICE. NO PT INJURY OR SURGICAL DELAY WAS REPORTED. CO DISCLAIMER: "CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT."
SUMMONS & COMPAINT RECEIVED ALLEGING TSS.
510K #912002 1 PERSON SERIOUS INJURY. TYPE G.
THE REPORTER INDICATED THAT INTERMITTENT VENTRICULAR OVERSENSING WAS OBSERVED.
DEVICE WAS USED DURING AN LAVH. THE DEVICE BROKE ON THE 5TH FIRING. THE DEVICE CLOSED NORMALLY. THE SURGEON MET RESISTANCE WHEN ATTEMPTING TO FIRE AND A "SNAP" WAS HEARD. THE INSTRUMENT DID NOT CUT OR STAPLE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND WORKED FINE. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAT INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE INSTRUMENT EJECTED CLIPS PREMATURELY INTO THE PT'S CAVITY AND CLIPS DID NOT FORM PROPERLY. THE SURGEON RETRIEVED THE CLIPS LAPAROSCOPICALLY WITHOUT INCIDENT.
THE REPORTER INDICATED A LOSS VENTRICULAR CAPTURE DURING MAGNET MODE. THE CAPTURE WAS NORMAL IN THE DEMAND MODE.
REPORT RECEIVED ALLEGING MEDICAL ATTENTION WAS REQUIRED AFTER EXPERIENCING AN INSERTER INJURY.
510K #912002. 1 PERSON SERIOUS INJURY. TYPE G.
H4: MFG DATE = 9/93. SUMMARY OF EVALUATION: THE INSERT SNAPPED ONTO A BASEPLATE, LOCKING CORRECTLY WITH A GOOD SNUG FIT AND COULD NOT BE REMOVED BY HAND.
THE PUMP OVERINFUSED AND THE PT RECEIVED AN OVERDOSE OF MEDICATION. A 60CC SYRINGE WAS FILLED, AND AFTER 40 MINUTES THE NURSE RESPONDED TO A PUMP ALARM AND THE SYRINGE WAS EMPTY. THE PT'S STATUS WAS NOT REPORTED, HOWEVER, THE PT WAS GIVEN NARCAN.
MFR'S REPORT DATE 10/25/96. THE UNIT WAS RETURNED AND COMPLETE VISUAL AND FUNCTIONAL TESTING WAS PERFORMED WITH NO FAULT FOUND. THE PUMP WAS FOUND TO MEET ALL MFG SPECS. IT WAS NOTED THAT THE PUMP WAS TESTED AT THE USER FACILITY AND THEY WERE UNABLE TO DUPLICATE THE REPORTED FAILURE. THIS ENTIRE MEDWATCH REPORT WAS COMPLETED BY THE MFR.
THE REPORTER INDICATED THAT A MALFUNCTION WAS SUSPECTED.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE HIGH LEAD IMPEDANCE AND HIGH AMPLITUDE READINGS WERE THE RESULT OF A MALFUNCTIONING ANALOG SWITCH. A3 ON THE PRINTED CIRCUIT BOARD "C".
FIVE DEVICES WERE BEING USED IN MENISCAL REPAIR SURGERY WHEN SUTURE BROKE FREE FROM DEVICE. EXPIRATION DATE 6/1/2001.
CONTACT REPORTED A SURGICAL DELAY OCCURRED. NO PT INJURY WAS REPORTED. REVIEW OF LOT HISTORY REVEALED NO MFG ISSUES WITH THIS LOT AND NO OTHER COMPLAINTS FOR THIS LOT. AN EVALUATION OF A SAMPLE OF PRODUCT IN INVENTORY REVEALED NO PRODUCT DEFECTS. CO DISCLAIMER: "CO IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY CO WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, CO OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT."
THE TIBIAL INSERT WOULD NOT FIT PROPERLY IN THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: A FUNCTIONAL CHECK OF THE INSERT REVEALED THE SNAP TAB LOCKED CORRECTLY WITH A GOOD SNUG FIT. SINCE THE EVENT COULD NOT BE DUPLICATED, THE REASON IT WAS NOT POSSIBLE TO SNAP THE INSERT INTO THE BASEPLATE IS NOT KNOWN.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE INSTRUMENT EJECTED UNFORMED CLIPS PREMATURELY. THE SURGEON RETRIEVED THE CLIPS WITHOUT PT INJURY.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIPS DID NOT HOLD THE VESSEL. THE LOOSE CLIPS WERE REMOVED. A SECOND DEVICE WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY.
THE REPORTER INDICATED A KEYBOARD RESPONSE DEFECT.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE "KEYPAD RESPONSE ANOMALY" WAS DUE TO AN INTERMITTENT SHORT OF THE VOLTAGE BUTTON ON THE KEYPAD.
NOTIFICATION RECEIVED FROM A MEDICAL MALPRACTICE CASE. IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, THERE WAS AN INJURY TO THE PT'S LEFT COMMON ILIAC ARTERY, ANTERIOR AND POSTERIOR WALLS. THERE WAS ALSO A SMALL BOWEL INJURY AND PNEUMOTHORAX. THE PT RECEIVED 2 UNITS OF FRESH FROZEN PLASMA, 9 UNITS OF PACKED RED BLOOD CELLS, AND 10 UNITS OF PLATELETS.
THE REPORTER INDICATED A CABLE RELEASE DEFECT.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE INABILITY OF THE PT CABLE TO BE INSERTED WAS THE RESULT OF A MISALIGNED PT CABLE CONNECTOR.
REPORTER STATED, THE TIBIAL INSERT WOULD NOT FIT PROPERLY IN THE BASEPLATE. THERE WAS NO ADVERSE CONSQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
IT WAS REPORTED THAT THE PT HAD AN IAB PLACED USING A RIGHT LEG INSERTION. THIRTY HRS LATER THE PT WAS BACK IN THE CATH LAB FOR ANOTHER PROCEDURE ON THE LEFT LEG. DURING REMOVAL OF THE SHEATH FROM THE LEFT SIDE, THE PT BECAME VERY AGITATED AND BENT BOTH HIS RIGHT AND LEFT LEGS. THE PUMP'S HIGH PRESSURE ALARMS WENT OFF AND BLOOD WAS NOTED IN THE CATHETER. THE IAB WAS REMOVED, AND SINCE THE PT WAS BEING WEANED FROM THE IAB, IT WAS DECIDED NOT TO REPLACE IT. THERE WERE NO PT COMPLICATIONS.
THE SAMPLE WAS RETURNED FOR EVALUATION. THE CATHETER WAS BENT BY THE USER AT A POINT 16.4 CM FROM THE BUSHING. NO LEAKS WERE OBSERVED IN THE CATHETER OR BALLOON WHEN TESTED WITH AIR INTRODUCED THROUGH THE PLUG. HOWEVER, WHEN THE CENTRAL LUMEN WAS AIR TESTED, AIR WAS NOTED EXITING THE DISTAL TIP OF THE BALLOON. IT WAS THEN CONFIRMED THAT THE CENTRAL LUMEN WAS FRACTURED WHERE IT WAS KINKED.
ON 8/9/96 DURING A PLATELETPHERESIS THE DONOR EXPERIENCED AN ACD REACTION DUE TO THE NURSE FORGETTING TO CLOSE THE ACD PUMP HANDLE ON THE ACCESS MANAGEMENT SYSTEM. THE DONOR EXPERIENCED THE FOLLOWING SYMPTOMS: TIGHTNESS OF THE CHEST, DIFFICULTY BREATHING, AND VOMITING. 50 LITERS OF OXYGEN WAS GIVEN AT THE CENTER TO IMPROVE THE BREATHING. TUMS TABLETS WERE ADMINISTERED ORALLY (CALCIUM SOURCE). THE DONOR WAS KEPT IN THE CENTER FOR APPROXIMATELLY 40 MINUTES AND RELEASED IN GOOD CONDITION. ONE OF THE NURSES SAW THE DONOR LATER ON THAT DAY AND MENTIONED THAT THE DONOR LOOKED FULLY RECUPERATED.
EACH EVENT PROBLEM CODE PT/DEVICE CODE) ADDRESSED IN LABELING? YES. MFR DESCRIBES IN THE DIRECTIONS FOR USE OF THE DISPOSABLE KIT, THE PROPER TECHNIQUE FOR PLACING THE ACD PUMP TUBING IN THE ACD PUMP AND CLOSING THE ACD PUMP HANDLE OF THE ACCESS MGMT SYSTEM. UNDER THE ADVERSE EFFECTS: A STATEMENT APPEARS ADDRESNG THE EFFECTS THAT A VERY RAPID RATE OR INFUSION OF ANTICOAGULANT HAS ON THE DONOR. USER FACILITY. CONTINUATION FROM SECTION H:DEVICE MFRS ONLY: EVALUATION CODE CONCLUSION: 70 (DEVICE DISCARDED, UNABLE TO FOLLOW UP).
THE REPORTER INDICATED THAT THE DEVICE WAS PROGRAMMED TO A RATE OF 50, BUT FOR LAST TWO TELEPHONIC FOLLOW-UP CHECKS, THE RATE WAS AT 72 BPM. THE PT WAS BROUGHT INTO THE OFFICE AND SUCCESSFULLY REPROGRAMMED TO 50. THE MAGNET RATE=83.4. THE DEVICE IS INCLUDED IN THE SAFETY ALERT.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
ON 10/17/96 APPROX 1 HOUR INTO PLATELETPHERESIS PROCEDURE , THE DONOR EXPERIENCED THE FOLLOWING SYMPTOMS: TINGLING VIBRATING, LIGHT HEADED AND PALE. THE NURSE NOTICED THAT THE ACD PUMP HANDLE HAD BEEN LEFT OPEN. THE NURSE NOTICED ON THE ACD BAG THAT 975 ML HAD BEEN USED. 3742 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE DONOR WAS GIVEN TUMS AND JUICE. HE RECUPERATED OKAY AND RELEASED IN GOOD CONDITION. THIS IS A MALE DONOR WEIGHING 150 POUNDS, APPROX 38 YRS OLD. POST MARKET QUALITY ASSURANCE REQUESTED THAT CO CLINICAL EDUCATIONAL DEPT OFFER THE CUSTOMER DD'L TRAINING.
EACH EVENT PROBLEM CODES (PT DEVICE CODE) ADDRESSED IN LABELING? YES. MFR DESCRIBES IN THE DIRECTIONS FOR USE OF THE ACCESS MANAGEMENT SYSTEM. UNDER THE ADVERSE EFFECTS: A STATEMENT APPEARS ADDRESSING THE EFFECTS THAT A VERY RAPID RATE OR INFUSION OF ANTICOAGULANT HAS ON THE DONOR. USER FACILITY. CONTINUATION FROM SECTION H: DEVICE MANUFACTURERS ONLY: EVAL CODE CONCLUDION: 70 (DEVICE DISCARDED, UNABLE TO FOLLOW UP).
THE BROACH HANDLE SHEARED OFF WITH THE PIN INBEDDED IN THE BROACH. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT DUE TO THIS EVENT.
THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO FATIGUE OF THE LOCATING PIN DUE TO REPEATED IMPACTING. THE RELIABILITY IS DECREASED IF THE BROACH HANDLE IS NOT FULLY TIGHTENED TO THE BROACH DURING IMPACTING. CORRECTIVE ACTION WAS IMPLEMENTED TO IMPROVE THE RELIABILITY OF THE LOCATING PIN.
THE INSTRUMENT WAS RETURNED FOR EVALUATION. UPON PERFORMANCE TESTING THE MISSING SEGMENT COMPLAINT WAS NOT CONFIRMED. THE CAUSE OF THIS OBSERVATION WAS NOT MISSING SEGMENTS BUT FADING OF THE SEGMENTS. INVESTIGATION INTO THIS CAUSE OF A FADING DISPLAY WAS IDENTIFIED AS A PCB CONTAMINATION/CORROSION. THE MOST PROBABLE CAUSE OF THE FADING DISPLAY CAME FROM AGGRESSIVE CLEANING OF THE UNIT BY THE CUSTOMER.
THE DEVICE WAS USED DURING A LAP PRE-PERITONEAL HERNIA REPAIR PROCEDURE. IT WAS REPORTED THE BALLOON BURST AT 32 PUMPS, BUT WAS INTACT AND THERE WERE NO FRAGMENTS WITHIN THE PT. THE SURGEON WAS ABLE TO COMPLETE PROCEDURE, BUT PROCEEDED WITH A TRANSADOMINAL APPROACH. THE SURGEON DID NOT USE ANOTHER DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: INSTRUMENT RECEIVED WITH AN EXTERNAL RING PROTRUDING THROUGH TIP OF BALLOON.
DURING A SUB-TOTAL GASTRECTOMY PROCEDURE, THE INSTURMENT DID NOT STAPLE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
ON 10/3/96 A DONOR HAD EXPERIENCED AN ACD REACTION DURING A DONATION DUE TO THE ACD PUMP TUBING ROLLING OFF FROM THE ACD PUMP. THE APHERESIS SUPERVISOR STATED THAT THERE WAS AN INLET LINE ALARM DURING THE PROCEDURE AND THE NURSE HAD ADJUSTED THE WHOLE BLOOD RATE TO 50. THE NURSE DID NOT ADJUST THE ACD RATIO WHICH WAS RUNNING AT 11:1. THE DONOR COMPLAINED OF VISUAL DISTURBANCES, NUMBNESS AND TINGLING OF THE LIPS AND CHEST TIGHTNESS. THE PROCEDURE WAS IMMEDIATELY DISCONTINUED, SALINE WAS ADMINISTERED, TUMS WAS GIVEN ORALLY WITH MILK. THE NURSE NOTICED THAT THE ACD TUBING HAD ROLLED OFF THE ACD PUMP AND THE ACD FREE-FLOWED FOR APPROX 32 MINUTES. THE DONOR RECEIVED 400-500 MLS OF ACD IN THIS TIME PERIOD. THE DONOR WAS KEPT FOR OBSERVATION FOR ONE HOUR AND RELEASED IN GOOD CONDITION.
EACH EVENT PROBLEM CODES (PT/DEVICE CODE) ADDRESSED IN LABELING? YES. MFR DESCRIBES IN THE DIRECTIONS FOR USE OF THE DISPOSABLE KIT, THE PROPER TECHNIQUE FOR PLACING THE ACD PUMP TUBING IN THE ACD PUMP ROLLELR AND CLOSING THE ACD PUMP COVER. UNDER THE ADVERSE EFFECTS: A STATEMENT APPEARS ADDRESSING THE EFFECTS THAT A VERY RAPID RATE OR INFUSION OF ANTICOAGULANT HAS ON THE DONOR. USER FACILITY. CONTINUATION FROM SECTION H: DEVICE MFRS ONLY: EVALUATON CODE CONCLUSION: 70 (DEVICE DISCARDED, UNABLE TO FOLLOW UP).
REPORT RECEIVED OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION WITH MIGRATION AWAY FROM THE LEAD BODY.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAD FRACTURED AT WELD SITE, ~7MM AND ~27MM PROXIMAL OF WELD WITH NO OTHER PORTION OF THE J STIFFENER WIRE RECEIVED. THE OUTER POLYURETHANE INSULATION WAS RECEIVED WITH AND ABRADED HOLE ~34MM PROXIMAL OF WELD SITE. IT APPEARS THAT ~61MM OF THE J STIFFENER WIRE WAS NOT RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO ~27MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS, X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURES AND CONFIRMS THAT ONLY ~27MM OF THE J STIFFENER WIRE WAS RECEIVED.
THE REPORTER INDICATED THAT THE TELEMETRY DATA FROM APRIL OF THIS YR WAS NORMAL, BUT UNFORTUNATELY NO PRINTOUTS ARE AVAILABLE AT THIS TIME. TELEMETRY FROM JULY AND SEPT. '96, WAS NORMAL FOR THE VVI MODE, BUT IN THE DDD AND DDI MODES, THE VALUES ARE ABNORMAL AND INCONSISTENT. NO PACING AND SENSING ANOMALIES HAVE BEEN REPORTED.
THE CANAL WAS BROACHED AND FEMORAL STEM WAS ATTEMPTED TO BE IMPLANTED. THE FEMORAL STEM DID NOT FIT PROPERLY IN THE CANAL. THE SURGEON REMOVED THE IMPLANT AND IMPLANTED A ALTERNATE STEM. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT DUE TO THIS EVENT.
SUMMARY OF EVALUATION: THE COMPLAINT COULD NOT BE DUPLICATED. NO ANOMALIES WERE OBSERVED. F1-14: HAS BEEN FILLED OUT BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY AND IS UNOBTAINABLE.
THE CUSTOMER REPORTS THAT SEVERAL INCIDENTS OCCURRED IN WHICH THE PEEP (POSITIVE END EXPIRATORY PRESSURE) INCREASED. THERE IS NO OTHER INFO AVAILABLE.
THIS MEDWATCH REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION. THE CO RECEIVED THE ATTACHED LIST DURING A CO SALES REP'S VISIT TO HOSP FOR ANOTHER ISSUE, WHICH PUT THE CO IN A COMPROMISING POSITON. DETAILS CONCERNING EACH INCIDENT ARE SIMPLY NOT AVAILABLE FROM THE HOSP. ACCORDINGLY, CO HAS FILED THEM UNDER ONE REPORT. CO ALSO RECOGNIZES THAT THIS REPORT IS BEING FILED AFTER THE 30 DAY REQUIREMENT. THE INITIAL INFO RECEIVED FAILED TO SUPPORT WHETHER AN MDR WAS REQUIRED, FOLLOW-UPS TO OBTAIN ADD'L INFO PROVED TO BE UNSUCCESSFUL. IN AN ABUNDANCE OF CAUTION, CO HAS DECIDED TO FILE THIS MEDWATCH REPORT. 100 - THE DEVICE WAS NOT EVALUATED BY CO. HOWEVER, CO HAS REQUESTED THAT THE VENTILATORS BE RETURNED FOR EVALUATION/REPAIR.
ON 10/17/96 APPROX 1 HOUR AND 10 MINS DURING A PLATEPHERESIS PROCEDURE WHEN 4250 ML OF WHOLE BLOOD HAD BEEN PROCESSED, THE DONOR COMPLAINED OF TINGLING OF THE LEGS ARMS CHEST AND FACE AND TIGHTNESS OF THE FACE. THE DONOR FELT HOT AND STARTED PERSPIRING. THE NURSE NOTICED AT THIS TIME THAT THE ACD PUMP HANDLE HAD BEEN LEFT OPEN. 100 ML OF ACD WERE LEFT IN THE BAG (900 ML ADMINISTERED). THE NURSE GAVE THE DONOR TUMS AND PLACED THE MACHINE ON HALT/IRRIGATE. THE SYMPTOMS QUICKLY SUBSIDED. THE DONOR WAS RELEASED IN GOOD CONDITION. THIS IS A MALE DONOR 185 POUNDS 33 YEARS OLD. THE CUSTOMER STATED THAT AS PART OF THE CORRECTIVE ACTION TO MINIMIZE THIS FROM OCCURRING, THEY ARE REQURING THAT THE NURSES VERIFY THAT THE ACD PUMP HANDLE IS DOWN (CLOSED) AND THAT THEY PUT BACK INTO THEIR PROCEDURE TO LOOK AT THE ACD BAG TO ESTIMATE THE ACD DELIVERY (ROUGHLY 100ML OF ACD USED PER 1000 ML OF WHOLE BLOOD PROCESSED). PMQA REQUESTED THAT CLINICAL EDUCATION DEPT OFFER ADD'L TRAINING TO THE CUSTOMER.
EACH EVENT PROBLEM CODES (PT/DEVICE CODE) ADDRESSED IN LABELING? YES. MFR DESCRIBES IN THE DIRECTIONS FOR USE OF THE DISPOSABLE KIT, THE PROPER TECHNIQUE FOR PLACING THE ACD PUMP TUBING IN THE ACD PUMP AND CLOSING THE ACD PUMP HANDLE OF THE ACCESS MANAGEMENT SYSTEM. UNDER THE ADVERSE EFFECTS: A STATEMENT APPEARS ADDRESSING THE EFFECTS THAT A VERY RAPID RATE OR INFUSION OF ANTICOAGULANT HAS ON THE DONOR. USER FACILITY. CONTINUED FORM SECTION H DEVICE MFR ONLY. EVAL CODE CONCLUSION: 70 (DEVICE DISCARDED, UNABLE TO FOLLOW UP).
ON 8/12/96 AT THE ONSET OF A PLATELETPHERESIS PROCEDURE, THE DONOR COMPLAINED OF NAUSEA, TINGLING OF THE FACE, HANDS AND BODY. IT WAS NOTICED BY THE NURSE THAT THE DONOR HAD RECEIVED 700 ML OF ACD IN APPROX 70 MINUTES (3,500 ML OF WHOLE BLOOD HAD BEEN PROCESSED) BECAUSE THE ACD PUMP HANDLE HAD BEEN LEFT OPEN ON THE ACCESS MGMT SYSTEM. THE DONOR WAS GIVEN TUMS AND JUICE AND WAS PLACED ON HALT/IRRIGATE FOR 10 MINUTES. THE PLATELETPHERESIS DONATION WAS CONTINUED AND COMPLETED. NO VITAL SIGNS WERE TAKEN AT THE TIME OF THE INCIDENT WAS NOTED. THE DONOR RECUPERATED OKAY AND RELEASED IN GOOD CONDITION. THE DONOR WAS FEMALE, WEIGHING 245 POUNDS, 5 FEET 5 INCHES TALL APPROX 30 YEARS OLD. THE NURSE STATED THAT AS PART OF THE CORRECTIVE ACTION THE ENTIRE STAFF WAS ALERTED OF THE INCIDENT AND INTERNALLY RETRAINED. THE INCIDENT HAD OCCURRED AT THE ONSET OF THE CONVERSATION TO THE ACCESS MGMT SYSTEM AND SHE CONSIDERED THE ISSUE PART OF THE LEARNING CURVE. THE CUSTOMER STATED THAT SINCE THE RETRAINING NO OTHER INCIDENTS OF THIS NATURE HAVE OCCURRED.
EACH EVENT PROBLEM CODE (PT/DEVICE CODE) ADDRESSED IN LABELING? YES. MFR DESCRIBES IN THE DIRECTIONS FOR USE OF THE DISPOSABLE KIT, THE PROPER TECHNIQUE FOR PLACING THE ACD PUMP TUBING IN THE ACD PUMP AND CLOSING THE ACD PUMP HANDLE OF THE ACCESS MANAGEMENT SYSTEM. UNDER THE ADVERSE EFFECTS: A STATEMENT APPEARS ADDRESSING THE EFFECTS THAT A VERY RAPID RATE OR INFUSION OF ANTICOAGULANT HAS ON THE DONOR. USER FACILITY. SECTION H DEVICE MFRS ONLY: EVALUATION CODE CONCLUSION: 70 (DEVICE DISCARDED, UNABLE TO FOLLOW UP).
DURING A THORACOSCOPIC LUNG RESECTION PROCEDURE, THE STAPLES AT THE DISTAL END DID NOT FORM PROPERLY AND BLEEDING WAS OBSERVED. THE SURGEON RELOADED THE INSTRUMENT AND COMPLETED THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEPTH GAUGE WAS DAMAGED, THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
THE DEVICE FAILED DUE TO MISUSE. DESGIN AND ENGRAVING INDICATE AN OLDER VERSION OF THE INSTRUMENT.
THE REPORTER INDICATED THAT IT WAS IMPOSSIBLE TO RECEIVE TELEMETRY OF THE PACER.
THE PHYSICIAN REPORTED THAT ON THE DEVICE THE CW DOPPLER SPECTRAL VELOCITY MARKERS DID NOT MATCH THE VELOCITY SCALE ON THE RIGHT SIDE OF THE SPECTRUM. THE DOCTOR WAS ATTEMPTING TO INTERPRET THE ECHO STUDY WHEN HE NOTICED THE DOTS DID NOT MATCH THE SCALE.
A CO CUSTOMER ENGINEER WENT TO THE MEDICAL CTR AND INSPECTED THE SYSTEM. CO WAS ABLE TO DUPLICATE THE PROBLEM. A SOFTWARE BUG WILL CAUSE THE DISPLAY OF THE CW DOPPLER SPECTRAL VELOCITY TO BE AMBIGUOUS IN A LIMITED SET OF CIRCUMSTANCES WHEN THE SYSTEM IS USED WITH CERTAIN DUAL FREQUENCY TRANSDUCERS. THE VELOCITY IS INDICATED BY A NUMERICAL SCALE ALONG THE RIGHT AXIS OF THE DISPLAY. IN ADDITION, THERE ARE HORIZONTAL DOTTED GRID LINES ACROSS THE ENTIRE SPECTRAL VELOCITY PILOT. IN THE AFFECTED SCREENS, THE GRID LINES ARE NOT ALIGNED WITH THE NUMERICAL SCALE. THE PROBLEM IS CLEARED BY ANY CHANGE OF SYSTEM CONTROL EG, OPERATING MODE OR SCALE OR BY AN IMAGE FREEZE/UNFREEZE COMMAND. IN THE EVENT THAT THE BUG IS ACTIVATED AND THE USER RELIES ON THE GRID LINES RATHER THAN THE NUMERICAL SCALE TO DETERMINE THE VELOCITY, AN INACCURATE DIAGNOSIS MAY RESULT.
DURING A TOTAL GASTRECTOMY PROCEDURE, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/17/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN E1 ADDRESS AND PHONE #), D9 AND F5. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
THE REPORTER INDICATED THAT AN INTERMITTENT LOSS OF ATRIAL CAPTURE WAS OBSERVED. THE SALES REP WAS FAXED THE INFO. NO FURTHER INFO WAS AVAILABLE REGARDING THE COMPLAINT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIP WERE FALLING OUT OF THE DEVICE. A SECOND DEVICE WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. 10/1/96, REP REPORTS CLIPS WERE RETRIEVED FROM THE PT AND IT IS BELIEVED NO CLIPS WERE LEFT IN THE PT.
D5;H4: INFORMATION NOT PROVIDED BY AFFILIATE. 10/2/96 1515 MESSAGE AND 800# FOR MD CALL BACK. KJB. 10/3/96 NNCL SENT. KJB.
ON 9/26/96, THE MFR RECEIVED INFO FROM ITS DISTRIBUTOR THAT A FACILITY IN THEIR TERRITORY EXPERIENCED DIFFICULTIES WITH THIS DEVICE. THE REPORT STATES THAT FOREIGN MATERIAL IS CONTAINED IN THE DEVICE SEPTUM. EXPIPRATION DATE: 7/14/2001.
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND HAS BEEN ANALYZED AS FOLLOWS: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. A VISUAL EXAMINATION CONFIRMED FOREIGN MATERIAL IN OR UNDER THE DEVICE SEPTUM.THIS EVENT IS BELIEVED TO HAVE OCCURRED DURING THE MANUFACTURE AND PACKAGING OF THE DEVICE. THE REPORT OF FOREIGN MATERIAL IN THE DEVICE SEPTUM HAS BEEN CONFIRMED AND CORRECTIVE ACTION HAS BEEN TAKEN. THE FACILITY WILL BE NOTIFIED OF THE REVIEW OF THIS INCIDENT. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS NOW CLOSING THE FILE ON THIS EVENT.
THE REPORTER INDICATED THAT AN INTERMITTENT LOSS OF ATRIAL SENSING OCCURED.
REPORTER STATES, UPON INSPECTION OF THE DEVICE PRIOR TO BEING SENT TO THE HOSP. IT WAS NOTICED THE POSTERIOR ASPECT OF THE TRIAL WAS BROKEN OFF AND FOUND TO BE UNSTABLE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVALUTION: EVENT ASSOCIATED WITH USER MISUSE OR CARELESS HANDLING OF THIS DEVICE. F1-14: HAS BEEN COMPLETED BY THE MFR. THSI EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
ON 9/24/96, THE CUSTOMER REPORTED FIVE POSITIVE BHCG RESULTS WHICH WERE CONFIRMED AS NEGATIVE BY ANOTHER TEST AND BY THE ASSAY INSTRUMENT TROUBLESHOOTING THE NEXT DAY. SERVICE WAS IN THE ACCOUNT PRIOR TO THE EVENT. THE CUSTOMER RAN AS USUAL AND DID NOT RUN CONTROLS AFTER SERVICE LEFT. THE CUSTOMER BECAME SUSPICIOUS BECAUSE ALL FIVE OF THE PTS, WHICH WERE FROM ER, WERE POSITIVE, THE CUSTOMER TRIED TO CALIBRATE THE ASSAY AND IT FAILED. WHILE TROUBLESHOOTING THE INSTRUMENT, THE CUSTOMER NOTICED THERE WAS A LEAK IN BULK SOLUTION 3. TIGHTENING THE CONNECTIONS AND FLUSHING LINES 1 AND 3 RESOLVED THE ISSUE, THE PTS' SAMPLES WERE RETESTED THE FOLLOWING DAY AND THEY WERE ALL NEGATIVE. CORRECT RESULTS WERE ISSUED. NO REPORT OF INJURY.
ON 9/24/96, THE CUSTOMER REPORTED FIVE POSITIVE BHCG RESULTS WHICH WERE CONFIRMED AS NEGATIVE BY ANOTHER TEST AND BY THE ASSAY INSTRUMENT, AFTER TROUBLESHOOTING THE NEXT DAY. SERVICE WAS IN THE ACCOUNT PRIOR TO THE EVENT. THE CUSTOMER RAN AS USUAL AND DID NOT RUN CONTROLS AFTER SERVICE LEFT. THE CUSTOMER BECAME SUSPICIOUS BECAUSE ALL FIVE OF THE PTS, WHICH WERE FROM ER, WERE POSITIVE. THE CUSTOMER TRIED TO CALIBRATE THE ASSAY AND IT FAILED. WHILE TROUBLESHOOTING THE INSTRUMENT, THE CUSTOMER NOTICED THERE WAS A LEAK IN BULK SOLUTION 3. TIGHTENING THE CONNECTIONS AND FLUSHING LINES 1 AND 3 RESOLVED THE ISSUE. THE PTS' SAMPLES WERE RETESTED THE FOLLOWING DAY AND THEY WERE ALL NEGATIVE. CORRECT RESULTS WERE ISSUED. NO REPORT OF INJURY.
ON 9/24/96, THE CUSTOMER REPORTED FIVE POSITIVE BHCG RESULTS WHICH WERE CONFIRMED AS NEGATIVE BY ANOTHER TEST AND BY THE ASSAY INSTRUMENT AFTER TROUBLESHOOTING THE NEXT DAY. SERVICE WAS IN THE ACCOUNT PRIOR TO THE EVENT. THE CUSTOMER RAN AS USUAL AND DID NOT RUN CONTROLS AFTER SERVICE LEFT. THE CUSTOMER BECAME SUSPICIOUS BECAUSE ALL FIVE OF THE PTS, WHICH WERE FROM ER, WERE POSITIVE. THE CUSTOMER TRIED TO CALIBRATE THE ASSAY AND IT FAILED. WHILE TROBLESHOOTING THE INSTRUMENT, THE CUSTOMER NOTICED THERE WAS A LEAK IN BULK SOLUTION 3. TIGHTENING THE CONNECTIONS AND FLUSHING  LINES 1 AND 3 RESOLVED THE ISSUE. THE PTS' SAMPLES WERE RETESTED THE FOLLOWING DAY AND THEY WERE ALL NEGATIVE. CORRECT RESULTS WERE ISSUED. NO REPORT OF INJURY.
ON 9/24/96, THE CUSTOMER REPORTED FIVE POSITIVE BHCG RESULTS WHICH WERE CONFIRMED AS NEGATIVE BY ANOTHER TEST AND BY THE ASSAY INSTRUMENT AFTER TROUBLESHOOTRING THE NEXT DAY. SERVIDE WAS IN THE ACCOUNT PRIOR TO THE EVENT. THE CUSTOMER RAN AS USUAL AND DID NOT RUN CONTROLS AFTER SERVICE LEFT. THE CUSTOMER BECAME SUSPICIOUS BECAUSE ALL FIVE OF THE PTS, WHICH WERE FROM ER, WERE POSITIVE. THE CUSTOMER TRIED TO CALIBRATE THE ASSAY AND IT FAILED. WHILE TROUBLESHOOTING THE INSTRUMENT, THE CUSTOMER NOTICED THERE WAS A LEAK IN BULK SOLUTION 3. TIGHTENING THE CONNECTIONS AND FLUSHING LINES 1 AND 3 RESOLVED THE ISSUE. THE PTS' SAMPLES WERE RETESTED THE FOLLOWING DAY AND THEY WERE ALL NEGATIVE. CORRECT RESULTS WERE ISSUED. NO REPORT OF INJURY.
ON 9/24/96, THE CUSTOMER REPORTED FIVE POSITIVE BHCG RESULTS WHICH WERE CONFIRMED AS NEGATIVE BY ANOTHER TEST AND BY THE ASSAY INSTRUMENT, AFTER TROUBLESHOOTING THE NEXT DAY. SERVICE WAS IN THE ACCOUNT PRIOR TO THE EVENT. THE CUSTOMER RAN AS USUAL AND DID NOT RUN CONTROLS AFTER SERVICE LEFT. THE CUSTOMER BECAME SUSPICIOUS BECAUSE ALL FIVE OF THE PTS, WHICH WERE FROM ER, WERE POSITIVE. THE CUSTOMER TRIED TO CALIBRATE THE ASSAY AND IT FAILED. WHILE TROUBLESHOOTIN THE INSTRUMENT, THE CUSTOMER NOTICED THERE WAS A LEAK IN BULK SOLUTION 3. TIGHTENING THE CONNECTIONS AND FLUSHING LINES 1 AND 3 RESOLVED THE ISSUE. THE PTS' SAMPLES WERE RETESTED THE FOLLOWING DAY AND THEY WERE ALL NEGATIVE. CORRECT RESULTS WERE ISSUED.L NO REPORT OF INJURY.
INVESTIGATION REPORT: THE ANALYZER GENERATED FIVE FALSE POSITIVE RESULTS FOR THE BHCG. THE CUSTOMER HAD OBSERVED A LOOSE CONNECTION IN THE MATRIX CELL WASH LINE, WHICH ALLOWED AIR TO BE INTRODUCED INTO THE SYSTEM. ONCE AIR ENTERED THE TUBING, WASH DISPENSE VOLUME DECREASED, AND PRODUCED THE EVELATED BHCG RESULTS. THE CUSTOMER TIGHTENED THE CONNECTIONS AND FLUSHED THE LINES TO RESOLVE THIS ISSUE. CORRECTIVE ACTIONS, FOR TROUBLESHOOTING THIS OBSERVED COMPLAINT, CAN BE FOUND IN THE OPERATIONS MANUAL: SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS; OBSERVED PROBLEMS FOR MEA TEST RESULTS TOO HIGH, AIR BUBBLES IN FLUIDICS COMPONENTS, AND MEIA TEST RESULTS ERRATIC. AN UPWARD TREND, PERTAINING TO THIS TYPE OF MALFUNCTION, HAS NOT BEEN FOUND. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS THE FINAL REPORT.
THE INFUSION PUMP WAS INVOLVED IN AN OVERDELIVERY OF A HEPARIN SOLUTION. WHEN THE PUMP DISPLAYED A VOLUME TO BE INFUSED OF 342 ML, THE 500 ML IV BAG HAD ONLY 50 ML REMAINING. HOWEVER, AFTER CALCULATING FROM THE PT'S MEDICAL RECORDS, APPROX 164 ML OF SOLUTION SHOULD HAVE BEEN THE AMOUNT REMAINING TO BE INFUSED. THE PT'S PTT LEVEL WAS ELEVATED AFTERWARDS AND THE HEPARIN DRIP WAS HELD FOR A FEW HOURS. THE PUMP WAS REMOVED FROM THE PT. NO ADD'L PT INTERVENTION WAS REQUIRED. THE PT RETURNED TO PRE-INCIDENT STATUS.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY FLOW ACCURACY TESTING WAS PERFORMED ON BOTH PUMP CHANNELS. THE RESULTS WERE WITHIN SPEC.
THE REPORTER INDICATED THAT AN INTERMITTENT LOSS OF ATRIAL SENSING AND A TOTAL LOSS OF ATRIAL CAPTURE WAS OBSERVED.
DURING A PNEUMONECTOMY PROCEDURE, THE INSTRUMENT LOCKED ON THE PULMONARY ARTERY. THE SURGEON MANUALLY MANIPULATED THE DEVICE FREE WITHOUT INCIDENT. THIS STATED THE STAPLE LINE WAS COMPLETED.
ON 9/26/96, THE MFR RECEIVED INFO FROM ITS DISTRIBUTOR THAT A FACILITY IN THEIR TERRITORY EXPERIENCED DIFFICULTIES WITH THIS DEVICE. THE REPORT STATES THAT FOREIGN MATERIAL IS CONTAINED IN THE DEVICE SEPTUM.
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND HAS BEEN ANALYZED AS FOLLOWS: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. A VISUAL EXAMINATION CONFIRMED FOREIGN MATERIAL IN OR UNDER THE DEVICE SEPTUM. THIS EVENT IS BELIEVED TO HAVE OCCURRED DURING THE MANUFACTURE AND PACKAGING OF THE DEVICE. THE REPORT OF FOREIGN MATERIAL IN THE DEVICE SEPTUM HAS BEEN CONFIRMED AND CORRECTIVE ACTION HAS BEEN TAKEN. THE FACILITY WILL BE NOTIFIED OF THE REVIEW OF THIS INCIDENT. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS NOW CLOSING THE FILE ON THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS NOW CLOSING THE FILE ON THIS EVENT.
DOCTOR WAS LOOKING THROUGH RESECTOSCOPE AND RECEIVED A VERY SLIGHT SHOCK TO THE EYE AREA. DOCTOR AND PT WERE NOT INJURED.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF NON-SPECIFIC LEAD MALFUNCTION.
THE LEAD WAS RECEIVED IN A PARTIAL DISTAL APPROX 37CM PORTION WITH NO J STIFFENER WIRE DISCREPANCIES. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES LEAD WAS CUT OR SNIPPED APPROX 37CM PROXIMAL OF ELECTRODE TIP, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS NO J STIFFENER WIRE DISCREPANCIES.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIPS WERE "SPITTING" AND NOT FORMING CORRECTLY. A SECOND DEVICE WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. 10/1/96 REP REPORTS CLIPS WERE RETRIEVED FROM THE PT AND IT IS BELIEVED NO CLIPS WERE LEFT IN THE PT.
D5;H4: INFORMATION NOT AVAILABLE. 10/01/96 1050 MESSAGE AND 800# FOR MD CALL BACK. KJB. 10/2/96 NNCL SENT. KJB.
THE LEAD WAS PARTIALLY EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
OTHER DEVICE MANUFACTURE DATE: 5/94. THE INCIDENT BEING REPORTED, WHICH OCCURRED ON 6/3/96, IS THE SECOND OF THE SAME NATURE AT THIS FACILITY. THE HOSP DID NOT FILE A MEDWATCH REPORT FOR THE FIRST INCIDENT, WHICH OCCURRED ON 5/21/96. IN BOTH INCIDENTS, THE REPORTED PROBLEMS WERE CAUSED BY REPAIR/ALTERATION OF THE TELESCOPES AT AN UNAUTHORIZED THIRD-PARTY REPAIR FACILITY. ON BOTH INSTRUMENTS THE DEVICE'S NON-CONDUCTIVE EYEPIECE HAD BEEN REPLACED BY A METALLIC, ELECTRICALLY CONDUCTIVE EYEPIECE. THE OPTICAL SYSTEMS HAD ALSO BEEN MODIFIED, AND UPON EVALUATION WERE DETERMINED TO MEET DEVICE'S STANDARDS OR SPECS.
REF. 1640319-1996-00464. THE REPORTER INDICATED THAT DURING A FOLLOW-UP CHECK ON 9/3/96, THE VENTRICULAR PULSE COULD NOT BE OBSERVED AFTER THE ATRIAL PACING ON ECG, AND THE INTRINSIC BEAT APPEARED AT 400 MSEC AFTER P-Q INTERVAL. WHEN TRYING TO INCREASE VENTRICULAR OUTPUT, NO CHANGE TO THE SITUATION WAS OBSERVED. A FRACTURE WAS SUSPECTED UNDER THE CLAVICLE WITH VENTRICULAR LEAD 430-10-04966 UNDER X-RAY, AND THE DR DECIDED TO REPLACE THE LEAD. FURTHER EVENT DESCRIPTION IS ON PAGE 3 OF THIS FORM.
THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING ENVIROMENTAL STRESS TESTING, AND CONNECTOR DIMENSIONAL ANALYSIS. NORMAL PACER OPERATION WAS OBSERVED. THE BATTERY IS PARTIALLY DEPLETED-NORMAL.
REPORT RECEIVED OF INNER ELECTRODE REGION KINKED WITH WIRE FRACTURE SUSPECTED BUT NOT VISUALIZED BY FLUOROSCOPY.
PT IN V-FIB VS ASYSTOLE. CPR STARTED. DEVICE AT BEDSIDE. WHEN ATTEMPTING TO INSERT THE DEFIBRILLATOR ASSEMBLY AND PADDLES INTO UNIT, WERE UNABLE TO REMOVE THE TESTING CABLE/ASSEMBLY. THREE NURSES ATTEMPTED TO REMOVE THE ASSEMBLY UNTIL ASSEMBLY WAS REMOVED. PACKAGE MARKED. DEFIB/PACER PADS CORRECTLY PLACED ON PT. MD WAS DEBATING DEFIB VS PACER MODE. WHEN DEFIB MODE CHOSEN, PADS WOULD NOT DISCHARGE, MONITOR READ PADDLE DEFAULT. PADS NOT USED, PT DEFIB USING PADDLES. THEN PACER MODE CHOSEN BY MD. THIS DEVICE NOT USED, ANOTHER CO'S PRODUCT USED WITH PACER RHYTHM OBTAINED.
UPON AUTOFILLING THE IAB BALLOON DID NOT HOLD VOLUME. THE IAB WAS REMOVED AND REPLACED WITH A NEW IAB, WITHOUT PT COMPLICATIONS.
ON 9/24/96, THE MFR'S MARKETING DIR IN FRANCE CONTACTED THE MFR AND REPORTED THAT AFTER REVIEWING THE FRENCH VERSION OF THE DEVICE CLINICIAN'S MANUAL, THEY HAD NOTED SEVERAL LINGUISTIC AND "RETYPING" MISTAKES ON THE FINAL TEXT. THE MARKETING DIR REPORTED THAT ON PAGE 44 OF THE CLINICIAN'S MANUAL, BACLOFEN DRUG APPENDIX, ALL OF THE DRUG DOSAGE UNITS ARE INCORRECT. THE DOSAGES SHOULD HAVE BEEN IN MICROGRAMS AND NOT IN MILLIGRAMS (MG) AS PRINTED. THE MARKETING DIRECTOR PLACED ALL OF THE CLINICIAN'S MANUALS ON HOLD UPON DISCOVERY OF THIS ERROR.
THE FOLLOWING CORRECTIVE ACTION HAS ALSO BEEN IMPLEMENTED AS A RESULT OF THIS EVENT: 1) THE DRAWING FOR THIS MANUAL HAS BEEN QUARANTINED AND AN ENGINEERING CHANGE ORDER WILL BE IMPLEMENTED TO MAKE THE NECESSARY CORRECTIONS TO THIS DRAWING, 2) THE MFR'S OFFICE HAS RETURNED THE REMAINDER OF THEIR INVENTORY OF THIS MANUAL (51) TO THE MFR AND THESE MANUALS WILL BE PLACED IN QUARANTINE. IN ADDITION, IT HAS ALSO BEEN DETERMINED THAT FIFTY (50) OF THESE MANUALS HAD BEEN DISTRIBUTED AT TRADE SHOWS; HOWEVER, NONE OF THESE MANUALS WERE ACCOMPANIED BY DEVICES. SHOULD ANY OF THE RECIPIENTS OF THESE CLINICIAN'S MANUALS PLACE AN ORDER FOR AN IMPLANTABLE INFUSION DEVICE, A CORRECTED VERSION OF THIS MANUAL WILL BE FORWARDED WITH THE DEVICE. ONE CLINICIAN'S MANUAL WAS SENT OUT WITH A MORPHINE IMPLANTABLE INFUSION DEVICE; HOWEVER, THE DEVICE AND MANUAL WERE INTERCEPTED IN CUSTOMS BY THE FOREIGN OFFICE AND THE MANUAL WAS REPLACED WITH A CORRECT VERSION PRIOR TO SHIPMENT TO THE CUSTOMER. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT. IN THE INITIAL REPORT, THIS EVENT WAS FILED AS A MALFUNCTION (UNDER H1); HOWEVER, THE REPORT SHOULD HAVE BEEN FILED AS OTHER: MISLABELED.
REF. 1640319-1996-00463. THE REPORTER INDICATED THAT DURING A FOLLOW-UP CHECK ON 9/3/96, THE VENTRICULAR PULSE COULD NOT BE OBSERVED AFTER THE ATRIAL PACING ON ECG, AND THE INTRINSIC BEAT APPEARED AT 400 MSEC AFTER P-Q INTERVAL. WHEN TRYING TO INCREASE VENTRICULAR OUTPUT, NO CHANGE TO THE SITUATION WAS OBSERVED. A FRACTURE WAS SUSPECTED UNDER THE CLAVICLE WITH VENTRICULAR LEAD 430-10-04966 UNDER X-RAY, AND THE DR DECIDED TO REPLACE THE LEAD. FURTHER EVENT DESCRIPTION IS ON PAGE 3 OF THIS FORM.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. DURING THE REPLACEMENT ON 9/9/96, BECAUSE BOTH THE VENTILATOR AND ATRIAL PACING THRESHOLDS WITH THOSE LEADS THAT HAD BEEN IMPLANTED WERE UNSTABLE, NEW ATRIAL AND VENTRICULAR LEADS WERE IMPLANTED FROM ANOTHER AIDE OF THE PT'S BODY. AFTER INSERTING THE NEW LEADS, THE ORIGINAL PACER WAS CONNECTED, BUT NO VENTRICULAR PULSE WAS OBSERVED. THE PHYSICIAN DECIDED THAT THE CAUSE WAS DUE TO THE ORIGINALY IMPLANTED PACER, AND IT WAS REPLACED. NO FURTHER INFO CAN BE OBTAINED FROM THE HOSPITAL. THE EXPLANTED DEVICE WILL BE SENT TO THE MFR FOR ANALYSIS.
UPON AUTOFILLING, THE BALLOON DID NOT HOLD VOLUME. THE IAB WAS REMOVED AND A SECOND WAS INSERTED WITHOUT ANY PROBLEM. CO ALSO RECEIVED THE MANDATORY MEDWATCH FORM FROM THE DISTRIBUTOR; UF/DIST REPORT #2026191-1996-0043).
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. A MEDWATCH FORM WAS REC'D FROM THE INITIAL RPTR OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCURRED.
5/2/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
THE REPORTER INDICATED THAT IT WAS IMPOSSIBLE TO COMMUNICATE WITH THE PACER USING A RX5000 OR A RX2000 PROGRAMMER. WHEN TRYING TO INQUIRE, A SCREEN MESSAGE APPEARED STATING "WAND TO FAR FROM DEVICE, TELEMETRY MAY BE ON-APPLY A MAGNET, ETC." THE WAND WAS MOVED AND THE MAGNET WAS APPLIED, BUT IT DID NOT HELP. TRANSMIT AND RECEIVE GAIN PARAMETERS WERE INCREASED; STATUS REMAINED AT NO SIGNAL. FURTHER EVENT DESCRIPTION OF THIS EVENT IS ON PAGE 3 OF THIS FORM.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. FURTHER DESCRIPTION: MAGNET RESPONSE GAVE THRESHOLD MARGIN TEST THEN PACING AT THE PROGRAMED RATE. THE PACER CAN BE PHYSICALLY FELT IN THE POCKET, SO THEY ARE CERTAIN THE WAND IS OVER THE PACER. THE DEVICE HAS APPROPRIATE PACING AND SENSING.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE DOPAMINE 800 MG/250 ML AT 5.6 ML/HR VIA LINE D. A NEW CONTAINER WAS HUNG AT APPROX 9 PM ON 9/24/96. AT 2:15 AM ON 9/25/96, THE PUMP GAVE AN AIR-IN-LINE ALARM ON LINE D AND THE NURSE NOTED THE IV CONTAINER WAS EMPTY. THE EXPECTED DELIVERY AMOUNT WAS APPROX 30 ML. THE INFUSION RATE WAS REPORTEDLY VERIFIED TO BE DISPLAYED AT 5.6 ML/HR. THE PT HAD BEEN UNRESPONSIVE WITH LABILE BLOOD PRESSURE PRIOR TO AND THROUGH THE EVENT. NO OVERT DIFFERENCE IN PT STATUS WAS NOTED, HOWEVER, THE NURSE STATED THE INCREASED DOPAMINE DELIVERY MAY HAVE CONTRIBUTED TO THE PT'S LABILITY. THE SOLUTIONS INFUSING ON THE OTHER PUMP LINES WERE NOT RECALLED, BUT "THEY INFUSED AS PROGRAMMED."
THE REPORTED PROBLEM COULD NOT BE DUPLICATED. FREQUENCY OF OCCURRENCE OF DEATH OR SERIOUS INJURY CODE 102 (OVERDELIVERY) COMPLAINTS FOR THIS DEVICE'S FAMILY IS APPROX. 0.85/MILLION SETS. FREQUENCY OF OCCURRENCE OF DEATH OR SERIOUS INJURY CODE 104 (FREEFLOW) COMPLAINTS FOR THIS DEVICE'S FAMILY IS LESS THAN 0.28/MILLION SETS. THE UNIT FAILED THE OCCLUSION PRESSURE TEST, BUT THIS FAILURE IS NOT RELATED TO THE REPORTED COMPLAINT.
THE DISPOSABLE LOADING UNIT WAS USED WITH INSTRUMENT DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE KNIFE BLADE DISENGAGED WHILE UNLOADING THE FULLY FIRED CARTRIDGE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT OPEN AND WAS DIFFICULT TO REMOVE. THE SURGEON MANUALLY MANIPULATED THE JAWS, OPENED AND REMOVED THE DEVICE WITHOUT INCIDENT.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT CUT. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE EXACT MFG SITE COULD NOT BE DETERMINED AS THE PRODUCTION LOT IS UNK.
DURING TESTING BY CLINICAL ENGINEERING IT WAS NOTED THAT THE PUMP "CONSISTENTLY OVERDELIVERS ON LINE B." IT WAS REPORTED THAT WITH SPEC LIMITS OF 20.0 +/-0.8 ML, THE PUMP KEPT INFUSING 21.2 ML INDICATING DELIVERY 2% OVER SPEC LIMITS. THE PUMP HAD BEEN SENT TO CLINICAL ENGINEERING WITH A COMPLAINT OF "DEAD BATTERY AND BLOWN FUSE." THERE WERE NO REPORTS OF ANY ADVERSE PT EFFECTS.
UNIT INVESTIGATION REVEALED THAT UNIT WAS SLIGHTLY OUT OF ADJUSTMENT (ABOUT 0.5% DELIVERY OVER SPECIFICATION LIMIT). UNIT WAS REPROCESSED AS NORMAL FOR RETURNED UNITS TO INCLUDE RECALIBRATION OF DELIVERY ACCURACY.
DURING A RESECTION OF THE UTERUS, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON APPLIED A NEW DEVICE AND SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING A SUB-TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY, ONE STAPLE REMAINED IN THE INSTRUMENT. THE HOSPITAL HAS REPORTED NO FURTHER INFO.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/23/96- MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
DURING AN UNSPECIFIED PROCEDURE, THE STAPLES DID NOT CLOSE PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
1/15/96- SUPPLEMENTAL REPORT #1 SENT TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE JAWS WERE DIFFICULT TO OPEN. THE SURGEON OPENED THE JAWS. SUBSEQUENTLY, THE JAWS DID NOT CLOSE IN ALIGNMENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER INSTRUMENT. THE HOSPITAL HAS REPORTED NO PT INJURY.
6/26/97-SUPPLEMENTAL REPORT #2 SUBMITTED TO FDA.
REPORT RECEIVED OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE SAFETY SHIELD WOULD NOT ADVANCE. THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME INSTRUMENT WITHOUT FURTHER COMPLICATIONS. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/22/96- SUPPLEMENT REPORT #1 SUBMITTED TO FDA. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6.
DURING A HERNIA PROCEDURE, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THIS PT HAS HAD A CHRONIC PLANTAR ULCER OF THE RIGHT FOOT FOR TWO YEARS. SHE RECENTLY DEVELOPED AN ELEVATED TEMPERATURE. ON 9/21/96 A CATHETER WAS INSERTED FOR IV ACCESS FOR LONG TERM IV ANTIBITIOTICS. THAT AFTERNOON A NURSE WAS UNABLE TO FLUSH THE CATHETER. THE SURGEON WAS ALSO UNABLE TO FLUSH IT. ON 9/23/96 THE CATHETER WAS EXPLANTED AND A NEW ONE WAS INSERTED.
THE CATHETER WAS RETURNED IN THREE SEGMENTS. THESE SEGMENTS APEAR TO BE CUT TO PRECLUDE REUSE. THE SEGMENTS WERE MATED AND THE EACH SEGMENT WAS FLUSHED. A LEAK WAS FOUND IN THE CENTER SEGMENT. UNDER MAGNIFICATION, THE LEAK SITE HAD A SUBTLE 'S' SHAPE AND WAS ABOUT .35" LONG. ALONG THE CURVE THE SURFACE TEXTURE WAS SMOOTH AND FINELY GRANULAR, WHILE THE SURFACE TEXTURE IN THE CENTER OF THE SPLIT WAS MORE ROUGH AND COARSE. THESE SIGNS INDICATED A BURST FAILURE POSSIBLY DUE TO OVERPRESSURIZATION OF AN OCCLUDED LUMEN.
NON-DELIVERY REPORTED. THE PUMP WAS INITIALLY SET TO INFUSE NITROGLYCERIN AT 20 MCG/MIN (6ML/HR). THE INFUSION DID NOT LOWER THE PT'S BLOOD PRESSURE AS EXPECTED, SO THE NURSE TITRATED THE INFUSION UP OVER AN UNSPECIFIED TIME PERIOD. WHEN THE RATE WAS AT 200 MCG/MIN (60 ML/HR), THE NURSE DISCONNECTED THE IV TO FLUSH THE PT LINE. AT THAT TIME SHE NOTED THERE WAS NO VISIBLE IV FLOW FROM THE TUBING. NURSE REPORTS, "THE PUMP INDICATED IT WAS FUNCTIONING PROPERLY AND WAS VERIFIED WITH WITNESSES. PUMP HAD ALL INDICATIONS OF PROPER FUNCTIONING BUT, WAS NOT INFUSING." THE PUMP WAS SWITCHED OUT AND THE PT'S BLOOD PRESSURE WAS THEN ADEQUATELY CONTROLLED. THERE WERE NO ADVERSE SEQUELAE REPORTED FROM THE INCREASED BLOOD PRESSURE. PRELIMINARY TESTING BY THE HOSP BIOMED ENGINEERING PERSONNEL CANNOT DUPLICATE THE EVENT.
TESTING AND INVESTIGATION DID NOT CONFIRM THE COMPLAINT OF "NON DELIVERY", HOWEVER TESTING DID INDICATE INITIAL SHORT TERM UNDERDELIVERY OF APPROXIMATELY 16%. THIS WAS CAUSED BY IMPROPERLY SET I/O VALVES. LONG TERM DELIVERY WAS FOUND TO BE WITHIN DEVICE SPECIFICATION. THE FREQUENCY OF DEATH OR SERIOUS INJURY REPORTS OF CODE 103 (UNDERDELIVERY) FOR LIFECARE 5000 IS APPROX. .05/MILLION SETS.
DURING A LOBECTOMY PROCEDURE, THE STAPLE LINE DID NOT FORM. THE HOSP HAS REPORTED NO PT INJURY.
DURING A BRECTOMY PROCEDURE, THE APPROXIMATING LEVER BROKE CAUSING DIFFICULTIES IN REMOVING THE DEVICE. THE SURGEON MANUALLY MANIPULATED THE DEVICE OFF THE TISSUE WITHOUT INCIDENT. A NEW INSTRUMENT WAS USED TO COMPLETE PROCEDURE.
DURING PLACMENT, THE NURSE ATTEMPTED TO REMOVE THE GUIDE WIRE BUT MET RESISTANCE. THE NURSE THEN TRIED TO REMOVE THE CATHETER AND GUIDE WIRE TOGETHER BUT WS UNSUCCESSFUL. AN X-RAY SHOWED A KNOT 4 CM FROM THE DISTAL TIP. A PHYSICIAN REMOVED THE CATHETER FROM THE PT WITH GREAT FORCE.
THE CATHETER HAD MULTIPLE BENDS IN IT ALONG WITH A KNOT APPROX 2.5 CM FROM THE DISTAL END. KNOTS CAN OCCUR WHEN THE CATHETER TIP ENCOUNTERS AN OBSTACLE, SUCH AS A VALVE OR SHARP BEND, AND THE CATHETER AND GUIDE WIRE FOLDS BACK ON ITSELF. THE INSTRUCTIONS FOR USE ENCLOSED WITH THE CATHETER DESCRIBE HOW TO PLACE A CATHETER IN A PT WITH A TORTUROUS VEIN PATH SO AS TO AVOID PROBLEMS WITH KINKED OR BENT CATHETERS.
DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT LOCK PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
IT WAS REPORTED DURING AN UNK PROCECURE, A LINEAR STAPLER WAS FIRED. THE PRODUCT CODE IS NOT KNOWN AT THIS TIME. WHEN THE STAPLER WAS OPENED TO REMOVE FROM TISSUE, THE STAPLE LINE BURST OPEN AND FECES ENTERED THE ABDOMINAL CAVITY. ANOTHER UNK STAPLER WAS USED TO COMPLETE THE CASE. THE REP IS GOING TO THE HOSP TOMORROW TO GATHER FURTHER INFO. 9/27/96 THE REP GAINED ADD'L INFO. IT WAS REPORTED THE TLC55 WAS USED DURING A PERFORATED BOWEL PROCEDURE. THE TLC WAS FIRED ACROSS THE SIGMOID AND THE PROXIMAL SEGMENT OF THE STAPLE LINE DEHISCED AND FECES ENTERED THE CAVITY. THS STAPLELINE WAS OVERSEWN. THERE WAS NO CONSEQUENCE TO THE PT.
D6-INFORMATION UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION. RESULTS OF EVALUATION: CONCLUSION: BASED ON THE INFORMATION RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RECEIVED WITH THREE FORMED STAPLES PRESENT IN THE DISTAL PORTION OF THE CARTRIDGE. THE RETURNED STAPLE HEIGHTS AND STAPLES FORMATION WERE MEASURED AND FOUND TO BE CONFORMING WITH RESPECT TO MFG REQUIREMENTS. ADDITIONALLY, THE INSTRUMENT WAS FIRED WITH A RELOAD CARTRIDGE AND STAPLE HEIGHTS AND STAPLE FORMATION WERE MEASURED. THESE WERE ALSO FOUND TO BE CONFORMING TO MFG REQUIREMENTS. THEREFORE, IT COULD NOT BE ASCERTAINED AS TO WHY THE STAPLE LINE REPORTEDLY DEHISCED. BATCH HISTORY RECORDS WERE REVIEWED AND THERE WERE NO ANOMALIES NOTED DURING MFG. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
USED TWO CONDOMS OF A BOX OF 6. BOTH RIPPED IN SAME SPOT. NEITHER WERE ANY GOOD.
THIS IS AN 81-YR-OLD FEMALE WITH A PMH OF CEREBRAL ATROPHY WITH DEMENTIA WHO WAS A PT AT A NURSING HOME. SHE WAS DISCOVERED BY THE NURSING HOME STAFF WEDGED BETWEEN THE SIDERAIL AND MATTRESS/BOXSPRING OF THE BED. WHEN FOUND SHE WAS IN FULL ARREST AND WAS POSITIONED WITH HER KNEES ON THE FLOOR, HER CHEST AND UPPER ABDOMEN COMPRESSED AND HER HEAD FREE WITH NO OCCLUSON OF THE MOUTH, NOSE, OR UPPER AIRWAY. SHE WAS PRONOUNCED DEAD SHORTLY AFTER DISCOVERY. AN AUTOPSY WAS CONDUCTED AT THE OFFICE OF THE MEDICAL EXAMINER ON 10/16/96. THE RESULT OF THAT AUTOPSY WAS THAT THE CAUSE OF DEATH WAS ASPHYXIA DUE TO TRAPPING BETWEEN SIDERAIL AND BED. A CONTRIBUTING FACTOR TO THIS DEATH WAS CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
IT WAS REPORTED THE DEVICE WAS USED DURING A BOWEL RESECTION. IT WAS REPORTED THE DEVICE WAS PLACED OVER BOWEL AND FIRED, THE FIRING KNOB ADVANCED ONLY HALFWAY AND JAMMED. THE SURGEON DISENGAGED THE DEVICE AND IT WAS OBSERVED NOT ALL THE STAPLES FIRED. THE ANASTOMOSIS WAS SHORTENED AND THE SURGEON HAND SEWED  TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE. ON 9/26/96 1554 SURGEON CONFIRMED THE INFO AS REPORTED BY THE SALES REP. SURGEON STATED ON THE THIRD FIRING THE INSTRUMENT "LOCKED UP." ONLY HALF OF THE STAPLELINE WAS FIRED WITH ONLY HALF OF THE CUT. THE INSTRUMENT WOULD NOT OPEN, AND TOOK "BRUTE STRENGTH" TO SEPARATE. THE REST OF THE TISSUE WAS HAND SEWED. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT APPEARS AS IF AN ATTEMPT WAS MADE TO FIRE THE INSTRUMENT ACROSS A HARD OBJECT. THIS IS EVIDENCED BY THE VISIBLE DAMAGE TO THE KNIFE AND CARTRIDGE. THE LOCK-OUT WAS RESET ON THE RETURNED CARTRIDGE AND THE INSTRUMENT WAS FIRED WITH THE RETURNED CARTRIDGE. DESPITE THE DAMAGE TO THE CARTRIDGE AND KNIFE, THE INSTRUMENT FIRED AND FORMED THE REMAINING STAPLES AS DESIGNED. ADDITIONALLY, THE INSTRUMENT WAS FIRED WITH A RELOAD CARTRIDGE AND FIRED AND FORMED STAPLES AS DESIGNED ACROSS THE ENTIRE STAPLE LINE WITH NO DIFFICULTIES NOTED. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
ON 2/1/96 THE COMPLAINANT OPENED A NEW PACKAGE OF CONTACT LENSES AND SHE NOTICED NOTHING UNUSUAL ABOUT THE FULLY SEALED CONTAINER. LENS WAS REMOVED FROM THE CONTAINER, RINSED OFF AND INSERTED INTO THE COMPLAINANT'S EYE. COMPLAINANT EXPERIENCED IMMEDIATE PAIN, REMOVED AND REINSERTED THE LENS. THE LENS WAS WORN FOR SEVERAL HRS, WHILE THE COMPLAINANT WAS AT THE OPERA, BEFORE IT WAS REMOVED AND PLACED INTO A STORAGE CASE. SEVERAL DAYS LATER THE COMPLAINANT EXPERIENCED THE SAME PROBLEMS WHEN SHE TRIED TO WEAR THE LENS AGAIN. ANOTHER LENS WAS OPENED UP AND THE SAME PROBLEM OCCURRED AGAIN. VISUAL EXAMINATION OF THE LENSES BY THE COMPLAINANT DID NOT REVEAL ANY PROBLEMS. ON 2/6/96 THE COMPLAINANT TELEPHONED THE CUSTOMER RELATIONS DEPT AND WAS INSTRUCTED TO RETURN THE LENSES TO THE PLACE OF PURCHASE AND HAVE THE RETAILER RETURN THE PRODUCT TO THE CO. THE COMPLAINANT RETURNED THE LENSES. APPARENTLY CO EXAMINED THE LENSES AND FOUND THAT ONE LENS WAS DAMAGED, TEARS AT THE EDGE AND CENTER OF THE LENS. THE MFR ATTRIBUTED THIS DAMAGE TO IMPROPER HANDLING OF THE LENS BY THE CONSUMER. COMPLAINANT STATED THAT SHE DID NOT MISHANDLE THE LENSES AND THAT THIS WAS NOT THE FIRST TIME SHE EXPERIENCED PROBLEMS WITH THIS CO'S LENSES.
RESIDENT WAS BEING TRANSFERRED WITH THE MECHANICAL LIFT. AS RESIDENT WAS LIFTED FROM CHAIR TO BED, THE BAR THAT HOLDS THE STRAPS BROKE APART FROM THE LIFT AND THE RESIDENT FELL TO THE FLOOR, SUPINE, HITTING THE BACK OF HER HEAD. 4 CM LACERATION WAS SUSTAINED TO THE RIGHT PARIETO-OCCIPITAL SCALP. 10/13/96 C-SPINE X-RAY APPEAR NEGATIVE FOR FRACTURES.
IT WAS REPORTED DURING A LAPAROSCOPIC CHOLELCYSTECTOMY, THE EPIGASTRIC PORT LEAKED CO2. AT THE END OF THE CASE WHILE THE SURGEON WAS CHECKING THE ABDOMEN WITH THE SCOPE, HE FOUND THE WHITE SEAL FROM THE FLAPPER VALVE IN THE PT. HE REMOVED THE SEAL AND CLOSED THE PORTS. THERE WAS NO CONSEQUENCE TO THE PT.
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
FRAGMENT "BROKE OFF" DURING CATARACT PROCEDURE. FRAGMENT ASPIRATED FROM THE EYE BY SURGEON. NO INJURY TO PT. THE DEVICE IS CONTAMINATED.
ON 6/6 PT WAS NOTIFIED THAT A CANNULA SLIPPED OFF INTO THE ABDOMEN DURING A LAPROSCOPIC  SPLENECTOMY. THE SURGEON IMMEDIATELY NOTICED IT, RETRIEVED IT AND CHANGED THE DEVICE. THE PT SUFFERED NO ADVERSE EFFECTS.
THE DISPOSABLE WAS USED WITH STAINLESS STEEL INSTRUMENT DURING AN ESOPHAGO GASTRECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT PARTIALLY FIRED. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVALUATION.
WHEN A SIZE 4 TRACHEOSTOMY TUBE WAS REMOVED FROM THE PT, THE FENESTRATED BODY OF THE OUTER CANNULA WAS FOUND TO BE "HANGING BY A THREAD." THE DEVICE WAS IN PLACE APPROX 3 1/2 MONTHS WHEN THE PT COMPLAINED THAT SHE FELT SHE HAS "NEEDLES IN HER THROAT." HER PEDIATRICIAN TREATED HER FOR AN INFECTION BY PRESCRIBING ANTIBIOTICS. AFTER 3 WEEKS WITHOUT RELIEF, THE PT'S ENT (WHO HAD SEEN THE PT STRICTLY TO REPLACE THE TRACH TUBES) REMOVED THE TUBE AND FOUND THE PROBLEM. NO PT INJURY WAS REPORTED AND THE PT CONTINUES AT BASELINE. THE PT IS DIAGNOSED WITH SEVERE SCOLIOSIS AND WEARS A HARRINGTON ROD. THE DEFECT WAS DISCOVERED WHEN THE DEVICE WAS REMOVED ON 7/26/96. HOWEVER, THE PROBLEM WAS NOT REPORTED TO CO BY HEALTHCARE PROVIDER    (WHICH PROVIDES THE PT WITH HER TRACH TUBES) UNTIL 9/25/96, APPARENTLY DUE TO SEVERAL CHANGES IN STAFFING AT HEALTHCARE PROVIDER. THE CURRENT HEALTHCARE ACCESSORIES CUSTOMER SERVICE/MARKETING PERSON CONTACTED THE CO'S SALES REPRESENTATIVE ABOUT THE COMPLAINT. ADD'L INFO WAS SUBSEQUENTLY OBTAINED BY DIRECTLY CONTACTING THE PT'S FATHER AND HER ENT.
IS EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? N. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IF "NO", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? N.
AFTER AN INTRAOPERATIVE CHOLEANGIOGRAM HAD BEEN COMPLETED, THE SLEEVE OF THE SURGICAL TROCAR HEAD BECAME DETATCHED AS THE GRASPERS WERE BEING INTRODUCED INTO THE SLEEVE. THE SLEEVE WAS EASILY RECOVERED. NO ADD'L PROCEDURE NECESSARY. NO ADVERSE OUTCOME TO THE PT.
THE DEVICE WAS USED DURING A COLON RESECTION. AFTER COMPLETING AN END TO END ANASTOMOSIS, THE SURGEON CHECKED THE PROXIMAL AND DISTAL TISSUE RINGS FROM THE SHAFT OF THE DEVICE. BOTH TISSUE RINGS WERE INCOMPLETE AND HE QUESTIONED THE PERFORMANCE OF THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
EVALUATION SUMMARY INADVERTENTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED ON THE INFORMATION RECIEVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RECEIVED WITH THE KNIFE STUCK IN THE UP POSITION AND WITH EXCESS DRIED FECAL MATTER PRESENT IN THE INSTRUMENT. DUE TO THE CONDITION OF THE INSTRUMENT, FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED. THEREFORE, IT COUDL NOT BE ASCERTAINED AS TO WHY THE DONUTS WERE REPORTEDLY INCOMPLETE. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH TEST STRIPS. ON 10/1/96 SHE OPENED THE SECOND BOTTLE IN A BOX OF FIFTY AND OBTAINED A CONTROL SOLUTION RESULT OF 16 MG/DL. THE CUSTOMER CALLED THE CO'S CUSTOMER SUPPORT LINE AND, WITH THE REPRESENTATIVE, PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 12 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 116-174 MG/DL. THE CONTROL SOLUTION DEVICE NORMAL CONTROL SOLUTION. LOT #VS155, EXPIRATION 6/97, WAS OPENED ONE WEEK AGO AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. ALSO WITH THE REPRESENTATIVE, THE CUSTOMER PERFORMED A CHECK STRIP TEST. THE RESULT WAS 78 VERSUS A RANGE OF 62-98. THE CUSTOMER STATED THAT THE FIRST BOTTLE PERFORMED ACCURATELY. THE DESICCANT IS IN THE OPEN BOTTLE.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 10/28/96. ONE OPENED BOTTLE CONTAINING 17 STRIPS WAS RETURNED TO CO FOR EVALUATION. THE TEST RESULTS OF THE RETURNED BOTTLE FELL BELOW THE SPECIFICATIONS FOR NORMAL CONTROL RANGE. EVALUATION OF THE DESSICANT INSIDE THE RETURNED BOTTLE INDICATES FAILURE MAY BE DUE TO EXPOSURE TO MOISTURE. THE SOURCE OF MOISTURE EXPOSURE IS UNK. CUSTOMER STATED THAT SHE OPENED THE SECOND BOTTLE IN A DISPLAY BOX OF FIFTY STRIPS AND OBTAINED A CONTROL SOLUTION RESULT OF 16 MG/DL. THIS INDICATES THAT MOISTURE EXPOSURE MAY NOT BE DUE TO CUSTOMER HANDLING THE PRODUCT. CO IS CONTINUING TO EVALUATE THE PACKAGING OF THE CUSTOMER'S RETURNED PRODUCT TO DETERMINE IF THIS RELATES TO THE CAUSE OF FAILURE. UPON COMPLETION OF THIS EVALUATION, A FOLLOW-UP REPORT WILL BE FORWARDED TO FDA. THE TIME FRAME TO COMPLETE THE EVALUATION IS APPROX 6 WEEKS. THE RETENTION SAMPLE TEST RESULTS FOR LOT 1L514A CONTINUE TO PROVIDE ACCEPTABLE PERFORMANCE. TREND ANALYSIS OF COMPLAINTS SHOWS THIS IS THE FIRST COMPLAINT FOR LOT 1L514A. BASED ON THE PRESENT EVALUATION AND THERE IS ONLY ONE COMPLAINT FOR THIS LOT OVER 10 MONTHS IN DISTRIBUTION, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELIN? NOT STATED. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURRING WITH FREATER SEVERITY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUSAL FOR DEVICE? N. D6 510K: K924398/B. INTERNAL REF NO: JM1029.
THE SENSE PACE LEAD ADAPTER WAS BROKEN AND CAUSING NOISE WHICH CHARGED THE ICD REPEATEDLY AND RESULTED IN LOW BATTERY VOLTAGE. THE ADAPTER WAS EXPLANTED ON 12/7/93. THERE IS NO INDICATION THAT THE ICD DID NOT FUNCTION PROPERLY.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT SPIT CLIPS WITHOUT FORMING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS OF BOTH INSTRUMENTS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENTS NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THIS INQUIRY WAS ORGINALLY REPORTED AS AN RPO "RECORD PURPOSE ONLY." IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
INFO ON AN EXPLANT REPORT STATED THAT THE SENSE PACE LEADS WERE CAPPED DUE TO NOISE.
EES #964985. A1,2,3,4; B3,6,7, D10: INFO NOT PROVIDED. D5,6; H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR EVAL. H6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
10/10/96 1000 SURGEON SAID IT IS VERY DIFFICULT TO FIRE ACROSS AN OLD STAPLE LINE WITH THE DEVICE. WHEN STAPLING THE ROUND LIGAMENT THE ENTIRE CUT LINE WAS NOT STAPLED. CLIPS WERE USED FOR HEMOSTASIS. THERE WAS NO CONSEQUENCE TO THE PT. TKB
A PHYSICIAN REPORTED A PT WHO WAS TREATED FOR THE FIRST TIME ON 4/3/96 TO THE UPPER AND LOWER VERMILION BORDERS. ON 5/13/96, THE PT PRESENTED WITH INTERMITTENT SWELLING AT ALL SITES OF TREATMENT (DATE OF ONSERT UNK). THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY AND PRESCRIBED A MEDROL DISEPAK. THE PT WAS RECENTLY SEEN (DATE UNK) WITH CONTINUING SYMPTOMS.
INFO WAS RECEIVED FROM FDA'S MEDWATCH PROGRAM, FDA #1013469. AN INITIAL MEDWATCH AND 3 SUPPLEMENTAL REPORTS HAVE BEEN FILED FOR THIS PT AND THIS EVENT. THIS REPORT IS FOLLOWUP #4. TWO E-MAILS FROM THE PT TO THE MEDWATCH PROGRAM DATED 09/04/1999 AND 09/05/1999, WERE FORWARDED BY FDA TO MCGHAN MEDICAL (FORMERLY COLLAGEN AESTHETICS CORP) AND RECEIVED AT FREMONT, CA FACILITY ON 02/16/1999. IN THE E-MAIL MESSAGES THE PT RECOUNTS SYMPTOMS AND MENTIONS SEVERAL NEW SYMPTOMS WHICH WERE NOT PREVIOUSLY REPORTED TO THE MFR. MCGHAN MEDICAL IS UNABLE TO SUBSTANTIATE ANY OF THE NEWLY REPORTED SYMPTOMS WITH A HEALTH CARE PROFESSIONAL DUE TO LITIGATION BY THE PT AND ADVICE FROM THE PT'S LEGAL COUNSEL THAT PT NOT PROVIDE ANY INFO TO MCGHAN MEDICAL. THE NEWLY REPORTED SYMPTOMS ARE: INTERSTITIAL CYSTITIS, HYPOTHYROIDISM, CHILLS, CHRONIC ELEVATED TEMPERATURE, AND HARD NODULES ON THIGHS AND CHEST. THE PT ALSO ALLEGES, "... PT ALSO HAS FIBROMYALGIA AS A RESULT OF THE COLLAGEN INJECTIONS." HOWEVER, WHEN INITIALLY REPORTING THIS INCIDENT PT LISTED FIBROMYALGIA AS A PRE-EXISTING CONDITION, ALTHOUGH THIS WAS NEVER SUBSTANTIATED BY A MEDICAL PROFESSIONAL.
IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM HAS SEVERAL PROBLEMS. THE ATRIAL LEAD WAS NOT SENSING AND THE VENTRICULAR LEAD EXHIBITED A LEAD FRACTURE ON X-RAY. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM. THERE WERE NO DIRECT ALLEGATIONS ON THE IPG. THE IPG WAS REPLACED AND THE LEADS WERE CAPPED.
A PHYSICIAN REPORTED A PT WHO WAS TREATED ON 10/11/96 TO THE GLABELLA, LOWER CHIN AND LINES BELOW THE LOWER LIP. APPROX FOUR HOURS AFTER THE TREATMENT, THE PT DEVELOPED SWELLING, TENDERNESS AND BRUISING AT THE GLABELLAR INJECTION SITE. OVER THE COURSE OF THE NEXT 2 DAYS, HE THEN DEVELOPED ERYTHEMA AND WHITE BUMPS DESCRIBED AS "PUSTULES" AT THE SITE. ON 10/14/96, THE PT'S WIFE CALLED TO REPORT THE SYMPTOMS. NO CRUSTING WAS REPORTED AND THE OTHER SITES OF TREATMENT WERE ASYMPTOMATIC. THE PHYSICIAN BELIEVED THE SYMPTOMS REPRESENTED A VASOSPASM OR POSSIBLE NECROSIS AND PRESCRIBED CIPRO, IBUPROFEN AND TOPICAL NEOSPORIN. HE HAD NOT SEEN THE PT SINCE THE DATE OF TREATMENT.
PT DID NOT COME IN FOR EVALUATION. HAS NOT BEEN SEEN SINCE INJECTION DATE. DATA UPDATED: PT FIRST SKIN TESTED 8/90. INDICATION FOR TREATMENT FROWN LINES. CAUSALITY: PROBABLY. NECROSIS AT INJECTION SITE.
IT WAS REPORTED THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. IT WAS REPORTED BY THE REP WHEN CLOSING INSTRUMENT OVER BOWEL, GAP SETTING MARKER SUDDENLY DISAPPEARED/JUMPED OUT. INSTRUMENT WAS OPENED, REMOVED FROM BOWEL AND CLOSED. INDICATOR WORKED PROPERLY. INSTRUMENT WAS THEN REAPPLIED TO BOWEL AND WAS NOT DAMAGED. A NEW INSTRUMENT WAS THEN REAPPLIED TO BOWEL AND WAS NOT DAMAGED. A NEW INSTRUMENT WAS APPLIED AND FIRED SUCCESSFULLY TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6;H3,4,6;G4: ADDED ADDITIONAL INFO. CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS CYCLED SEVERAL TIMES WITH NO DIFFICULTIES NOTED WITH THE INDICATOR DISAPPEARING OR LUMPING. ADDITIONALLY, THE INSTRUMENT WAS FIRED AND IT FORMED STAPLES AS DESIGNED ACROSS THE ENTIRE STAPLE LINE. THE INCIDENT THAT OCCURRED DURING SURGERY COULD NOT BE RECREATED. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
DURING THE REPLACEMENT PROCEDURE OF AN IMPLANTABLE PULSE GENERATOR (IPG) LEAD WAS CAPPED FOR POOR THRESHOLDS.
REPORTED STATED AFTER REDUCTION WITH THE TRIAL INSERT, THE IMPLANT INSERT WAS ASSEMBLED TO THE BASEPLATE. DURING REDUCTION WITH THE INSERT, THE JOINT WAS NOT STABLE.  ANOTHER INSERT WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT.
SUMMARY OF EVALUATION: AS RECEIVED, THE TIBIAL INSERT AND TRIAL INSERT WERE BOTH FUNCTIONALLY AND DIMENSIONALLY INSPECTED.  BOTH COMPONENTS WERE FOUND TO BE ACCEPTABLE TO DESIGN REQUIREMENTS DIMENSIONALLY AND FOR FUNCTIONAL FIT. THESE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS LIKELY ASSOCIATED WITH INTRA-OPERATIVE TECHNIQUE.
REPORTED STATED AFTER REDUCTION WITH THE TRIAL INSERT, THE IMPLANT INSERT WAS ASSEMBLED TO THE BASEPLATE. DURING REDUCTION WITH THE INSERT, THE JOINT WAS NOT STABLE. ANOTHER INSERT WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/17/96- MEDWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
THE INFUSION PUMP WAS REC'D AT THE SVC FACILITY WITH A VAGUE REPORT THAT IT WAS BEING USED ON A PT AND THE PUMP WAS INACCURATE. NO ADD'L INFO WAS REC'D. NO PT INJURY AS REPORTED.
UNSUBSTANTIATED LEGAL COMPLAINT WAS RECEIVED WHICH ALLEGES THAT THE PT RECEIVED BREAST IMPLANTS AND HAS SYMPTOMS WHICH INCLUDE ABNORMAL BRAIN MRI, SEIZURES, MEMORY LOSS, SERIOUS RASHES, ARTHRALGIAS, MYALGIAS, CHRONIC FATIGUE, DISPHAGIA, DRY EYES, AND BREAST DYSFUNCTION.
AS THE DEVICES WERE NOT RETURNED TO CO, NO PHYSICAL EVALUATION WAS POSSIBLE, AND NO CONCLUSION COULD BE DRAWN. THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFFR, PART 803.16 THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CUI CORPORATION THAT THE REPORT OF INFO THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. REPORTS ARE BASED ON INFO SUPPLIED TO CUI CORPORATION WITHOUT CO INDEPENDENT VERIFICATON AS TO ITS ACCURACY OR COMPLETENESS. IT IS UNDERSTOOD THAT THE INFO MAY NOT REPRESENT FACT AFTER INVESTIGATION. CUI CORPORATION'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. FILING AN MDR PURSUANT TO 21 CFR, PART 803.16 DOES NOT CONSTITUTE AN ADMISSION BY CUI CORPORATION THAT THE DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF A CAUSAL RELATIONSHIP BETWEEN THE EVENT REPORTED AND THE DEVICE. CUI CORPORATION DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE NECESSARILY AN ACCURATE REFLECTION OF THE RESULTS AND CONCLUSION OF THE DEVICE EVALUATION. CUI CORPORATION CONSIDERS THE INFO PROVIDED IN THIS REPORT TO BE HIGHLY CONFIDENTIAL, THEREFORE CO REQUEST THAT YOU PROTECT IT FROM ANY FOIA REQUEST.
PIECES OF THE TRIAL HEADS HAVE BROKEN OFF. THIS WAS DISCOVERED AT THE SALES OFFICE WHILE PREPARING THE INSTRUMENT CASE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THEREFORE, DID NOT CAUSE ANY ADVERSE CONSEQUENCE FOR ANY PT.
SUMMARY OF EVALUATION: THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO USER ABUSE OF THE TRIAL. IT APPEARS THAT THE USER IS TRYING TO DISASSEMBLE AN INNER CERAMIC SEAL TO BETTER CLEAN THE INSTRUMENT. THIS IS NOT RECOMMENDED. THE AGENT WAS REQUESTED TO INSTRUCT THE USER NOT TO DISASSEMBLE THE SEAL FROM THE TRIAL HEADS.
THE BLOOD PUMP LEAKED DURNG PRIMING. IT WAS NOT USED ON A PT. THE BLOOD PUMP HAS BEEN RETURNED TO CO FOR EVALUATION.
DURING SURGERY, THE TAPERS OF THE ONCOLOGY STEM AND DISTAL FEMORAL ONCOLOGY STEM COMPONENT DID NOT MATE TOGETHER PROPERLY. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVAL: THE PROXIMAL TIBIAL STEM SECTION WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THIS COMPONENT APPEARS TO BE IN NEW CONDITION, AND DIMENSIONALLY WAS FOUND TO MEET DESIGN REQUIREMENTS WHICH APPLIED AT THE TIME OF MFR. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS STEM SECTION FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. THIS EVENT IS ASSOCIATED WITH THE SURGEON'S OR AGENT'S EXPECTATION THAT THIS TIBIAL COMPONENT WILL MATE WITH A DISTAL FEMORAL ONCOLOGY COMPONENT CONTRARY TO THE ORIGINAL DESIGN INTENTIONS. CORRECTIVE ACTION WAS TAKEN BY CHANGING THE DESIGN TO ALLOW THE PROXIMAL TIBIAL STEM SECTION TO MATE SUCCESSFULLY WITH A FEMORAL BODY.
THE FEMORAL HEAD WOULD NOT ARTICULATE PROPERLY IN THE BIPOLAR CUP. ANOTHER CUP AND HEAD WERE READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
SECTION F: SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUMMARY OF EVALUATION: AS RECEIVED THE RETURNED BIPOLAR ASSEMBLY AND FEMORAL HEAD COMPONENT ARE OBSERVED TO BE IN GOOD CONDITION. A FUNCTIONAL TEST PERFORMED WITH THE RETURNED FEMORAL HEAD SHOWS THE HEAD DOES NOT ROTATE FREELY WHEN IT IS ASSEMBLED IN THE RETURNED BIPOLAR ASSEMBLY WITH THE LOCKING RING COMPLETED SEATED IN THE ASSEMBLY. INSPECTION REVEALED THE INSERT SPHERICAL DIAMETER TO BE IN COMPLIANCE WITH ENGINEERING SPECS AND THE LOCKING RING BUMP DIAMETER TO BE UNDERSIZE. DIMENSIONAL INSPECTION OF THE RETURNED FEMORAL HEAD COMPONENT FOUND IT TO BE COMPLIANCE WITH ENGINEERING SPECS. THE UNDERSIZE CONDITION OF THE LOCKING RING BUMP DIAMETER WAS MOST LIKELY THE CONTRIBUTING FACTOR FOR THE MATING FEMORAL HEAD NOT ROTATING FREELY WHEN ASSEMBLED IN THE ASSEMBLY. THE QRS HAS BEEN REVISED TO REQUIRE DIMENSIONAL INSPECTION OF THE LOCKING RING BUMP DIAMETER.
PT WAS SEATED IN A CHAIR MOUNTED SHOULDER CPM UNIT. HE PASSED OUT WHILE IN THE CHAIR. REP BRACED PT SO PT WOULDN'T HURT HIMSELF. PT'S TONGUE WENT TO THE BACK OF HIS HEAD. WIFE CALLED 911. AMBULANCE TOOK PT TO ER. PT WAS FOUND TO BE DEHYDRATED AND GIVEN FLUIDS. NO OTHER MEDICAL TREATMENT WAS PRESCRIBED.
RECEIVED COMPLAINT ON 9/16/96. THE COMPLAINT REPORTED THAT ON 8/27/96, AN EPIDURAL INTRODUCER WAS BEING WITHDRAWN AND BECAME HUNG UP. AS MORE FORCE WAS APPLIED TO REMOVE TO INTRODUCER, IT BEGAN TO STRETCH. A SMALL INCISION WAS MADE AT THE INSERTION SITE AND WITH THE AID OF STERILE FORCEPS THE DEVICE WAS REMOVED WITHOUT FURTHER COMPLICATIONS.
THE TIBIAL INSERT WAS NOT PROPERLY LOCKED INTO THE BASEPLATE. THIS INSERT WAS IMPLANTED INTO THE PT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME REPORTED AT THIS TIME.
SUMMARY OF EVAL: THE TIBIAL INSERT CAN NOT BE EVALUATED FOR THE REPORTED LOCKING DIFFICULTY WITH A BASEPLATE AS IT HAS NOT BEEN RETURNED TO CO BUT RATHER HAS BEEN IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS COMPONENT FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MANUFACTURE. IN THIS SITUATION, THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE TECHNIQUE.
THE CUSTOMER REPORTED THAT WHILE RUNNING AN HIV-1 P24 ANTIGEN ASSAY, THE SAMPLE HANDLER MISREAD A SAMPLE BARCODE. THE BARCODE WAS READ AS "053FY12379" INSTEAD OF "013FY12474." NO ERROR MESSAGE WAS GIVEN. AN ENGINEER HAS BEEN DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
WHILE OPENING THE PACKAGE OF BONE CEMENT, THE CIRCULATOR NURSE TOUCHED THE INNER STERILE POUCH. ANOTHER UNIT WAS READILY AVAILABLE AND USED TO COMPLETE THE SURGERY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT, DELAY IN SURGERY OR ANESTHESIA TIME.
THE CUSTOMER REPORTED THAT WHILE RUNNING AN HCV ASSAY, THE SAMPLE HANDLER FAILED TO PIPETTE THE CORRECT AMOUNT OF SAMPLE IN SEVERAL WELLS. NO ERROR AMOUNT OF SAMPLE IN SEVERAL WELLS. NO ERROR MESSAGE WAS GIVEN. AN ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP THAT THE INSTRUMENT JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
EVALUATION SUMMARY INADVERTENTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED INCIDENT OF THE INSTRUMENT "JAMMED" DURING SURGERY MAY HAVE BEEN DUE TO A DRY FIRE, CAUSING THE STAPLE TO RETRACT, UNATTACHED TO TISSUE, AND JAM IN THE NOSE. THE INSTRUMENT WAS RECEIVED WITH A FORMED STAPLE JAMMED IN THE CARTRIDGE NOSE AND WITH EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY. THE TUBE WAS OBSERVED TO BE BENT SLIGHTLY IN THE DISTAL PORTION. THE FORMED STAPLE WAS REMOVED FROM THE CARTRIDGE NOSE AND THE INSTRUMENT WAS CYCLED AND FIRED THE REMAINING 10 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO HOW THE TUBE HAD BECOME BENT. THE INSTRUMENT IS NOT DESIGNED TO BE FIRED WHILE NOT IN TISSUE OR A GAUZE SIMULATION OF TISSUE.
THE TIBIAL INSERT WOULD NOT LOCK PROPERLY IN THE BASEPLATE.  THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
TSUMMARY OF EVALUATION: THIS TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE ANTERIOR LOCKING TAB EXHIBITS DISTORTION DUE TO HAVING BEEN CRUSHED DURING THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. A QUERY OF THE PRODUCT EXPERIENCE REPORT DATABASE FOUND THAT NO OTHER SIMILAR EVENT HAD BEEN REPORTED FOR THIS LOT OF INSERTS. THE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES. IMPACTION OF A MISALIGNED INSERT DAMAGES THE ANTERIOR LOCKING TAB WHICH THEN PRECLUDES PROPER ASSEMBLY ONTO THE BASEPLATE.
THE ICD WAS BEING EVALUATED IN THE PHYSICIAN'S OFFICE FOR A LEAD IMPEDANCE OF <100 OHMS. ON X-RAY THERE WAS SOME QUESTION AS TO WHETHER ONE OF THE PINS FOR THE BIFURCATED SENSING LEAD WAS COMPLETELY IN THE HEADER. ON 10/11/96 SURGERY WAS PERFORMED. AFTER THE POCKET WAS OPENED, THE LEAD CONNECTION WAS EXAMINED AND BOTH PINS WERE SECURELY IN THE HEADER OF THE ICD. THE LEAD WAS TESTED AND THE BIPOLAR MEASUREMENTS INDICATED A LEAD FRACTURE. THE LEAD WAS CAPPED.
THE INSTRUMENTS ARE WORN AND THE GRIPS ARE CRACKED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT.
SUMMARY OF EVALUATION: THE ROOT CAUSE OF THE CRACKING IS ATTRIBUTED TO SUBJECTING THE DEVICE TO AN ACIDIC CLEANING SOLUTION. THE SALES REP IS INSTRUCTED TO REMIND THE USERS THAT DEVICES SHOULD NOT BE CLEANED WITH CLEANING SOLUTIONS HAVIND A PH > 7.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE WAS UNABLE TO BE INSERTED. THE REP STATED THAT ONE TIE DOWN POST APPEARS TO BE BROKEN OFF. THERE WAS NO CONSEQUENCE TO THE PT.
9/11/96 1035, THE SURGEON STATED HE DID NOT HAVE DIFFICULTY INSERTING THE TROCAR. THE TIE POST POPPED OFF ONTO THE STERILE FIELD WHEN HE PUT A TIE AROUND IT. ANOTHER 512B WAS OPENED TO COMPLETE THE CASE AND WORKED FINE. DEVICE NOT RETURNED FOR ANALYSIS.
WHILE INTRODUCING NOVOCAINE INTO THE PT'S GUM AREA FOR PURPOSES OF ANESTHESIA, THE NEEDLE BROKE IN A SOFT TISSUE AREA. AS A RESULT OF THIS INCIDENT THE PT UNDERWENT REMOVAL OF THE REMAINING PIECE OF NEEDLE AND ALLEGEDLY SUFFERED GENERAL AND SPECIAL DAMAGES.
REFERENCE MFR. COMPLAINT # D96-10-8-66. INFO IN THIS REPORT WAS SUPPLIED BY PLAINTIFF'S LAWYER. THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. NO ORDER NUMBER OR LOT NUMBER INFO WAS AVAILABLE. METALLURGICAL EVALUATION REVEALED THE NEEDLE WAS FRACTURED IN A MANNER CONSISTENT WITH EXCESSIVE OVERLOADING OF THE CANNULA CAUSED BY SEVERE BENDING AND SUBSEQUENT RESTRAIGHTENING. PRODUCT LABELING INSTRUCTS USER NOT TO BEND THE NEEDLE BEFORE USE. OTHER EVALUATION OR INVESTIGATION NOT POSSIBLE DUE TO LACK OF PRODUCT IDENTIFICATION. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO  A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR "BATTERY DEPLETION, TELEMETRY PROBLEM AND LOW OUTPUT." THE IPG HAS BEEN IMPLANTED FOR APPROX 36 MOS.
H4: MFG. DATE = 2/96. THE INSERT COULD NOT BE SNAPPED INTO POSITION BECAUSE OF THE DEFORMED SNAP TAB. THIS DAMAGE IS CONSISTENT WITH DOWNWARDS FORCE BEING APPLIED TO THE INSERT BEFORE IT IS SUFFICIENTLY FAR BACK TO ENGAGE CORRECTLY WITH THE POSTERIOR RETAINING FLANGES OF THE BASEPLATE.
DURING AN INVESTIGATION INTO A SUBSEQUENT EVENT, AN UNREPORTED EVENT WAS DISCOVERED. PER THE INFO PROVIDED TO CO THROUGH MEANS OF OPERATIVE NOTES REFERENCING A REVISION WHICH OCCURRED ON 4/15/96; REPORTED TO THE FDA ON 5/5/96, REPORT #1996-2125050-0292, ACCESS #M758980), THE DEVICE WAS REMOVED DUE TO A MALFUNCTION AND EROSION. AS STATED IN THE OPERATIVE NOTE (APPROX TWELVE YEARS AGO HE HAD THE INSERTION OF AN INFLATABLE PENILE PROSTHESIS THAT WORKED FOR OVER TEN YEARS, WHO WAS FOUND ON THE EASTERN SHORE TO HAVE MALFUNCTIONED, INCLUDING PRESUMABLY EROSION TO THE BLADDER. THE RESERVOIR WAS REMOVED AND THEN HE HAD A SEPARATE SETTING IN CO GFS TWO-PIECE INFLATABLE).
REQUEST FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURRONDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OR ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE DECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURE.
CERAMIC HEAD BROKE INTO MULTIPLE PIECES. DEVICE WAS REMOVED AND REPLACED.
THE SCREWDRIVER WILL NOT ROTATE BLADE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE EVALUATION RESULTS INDICATE THE SCREWDRIVER DID NOT OPERATE PROPERLY DUE TO IMPROPER CLEANING OF THE INSTRUMENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY, THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/17/96 - MEDWATCH NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
AT APPROX 10 AM NURSING ATTEMPTED TO INSERT FEEDING TUBE. SEVERAL ATTEMPTS WERE MADE. RESISTANCE MET. CHECKED END TUBE IN WATER; WHEN BUBBLED, REMOVED IMMEDIATELY. ATTEMPTS TERMINATED AT 10:20 AM. PHYSICIANS NOTIFIED. AT 11:00 AM PT EXPERIENCED RESPIRATORY DISTRESS. CODE CALLED, PT INTUBATED. CHEST TUBE PLACED. TRANSFERRED TO CRITICAL CARE. PT DIED OF TENSION PNEUMOTHORAX, RESPIRATORY ARREST.
THE HANDLE CRACKED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, THEREFORE, THIS EVENT DID NOT CAUSE ANY ADVERSE CONSEQUENCE FOR ANY PT.
SUMMARY OF EVALUATION: EVENT ATTRIBUTED TO REPEATED EXPOSURE TO MECHANICAL AND THERMAL STRESSES. HANDLE DESIGN MATERIAL HAS BEEN MODIFIED TO PRECLUDE FAILURE. F1-14: HAS BEEN COMPLETED BY THE MFR. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
WHILE SETTING UP INSTRUMENTS FOR SURGERY, IT WAS NOTICED THE GUIDE WIRE WAS OPENED. IT WAS DISCOVERED THE INNER PACKAGE HAD NOT BEEN SEALED. THIS EVENT DID NOT OCCUR DURING THE SURGICAL PROCEDURE. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR SURGICAL DELAY.
SUMMARY OF EVALUATION: THE DAMAGE TO THE PEEL POUCH MOST LIKELY RESULTED FROM THE PRODUCT BEING SUBJECTED TO EXCESSIVE EXTERNAL FORCES DURING SHIPPING AND HANDLING.
THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION REVEALED THE UNIT WAS PROPERLY ASSEMBLED. NO ANOMALIES TO THE NEEDLE/SHEATH ASSEMBLY WERE NOTED. FUNCTIONAL TESTS WERE PERFORMED. THE STYLET WOULDN'T RETRACT BECAUSE THE NEEDLE WAS CLOGGED WITH DRIED BLOOD. AFTER REMOVAL OF BLOOD AIR PASSED THROUGH THE NEEDLE. BIOPSY MATERIAL WAS FOUND TRAPPED IN THE DUCK-BILL VALVE, AND PREVENTED THE VALVE FROM CLOSING. BIOPSY RESIDUE COULD NOT BE REMOVED. REMAINING FUNCTIONAL TESTS WERE SUCCESSFUL. THE SAMPLE COMPLIED WITH ALL REQUIREMENTS. THE NEEDLE MOST LIKELY DID NOT CONTRIBUTE TO THE REPORTED INCIDENT. THE DOCTOR STATES, "HE WAS NOT SURE WHETHER THE PNEUMOTHORAX WAS DUE TO ANY LEAKAGE OR DEFECT IN THE DEVICE, OR DUE TO THE PT'S OWN CONDITION. PLASE NOTE THAT THIS REPORT MAY BE BASED UPON INFORMATION NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE.
CUSTOMER REPORTS, AFTER PLACEMENT (LARGE RT. PLEURAL INFUSION PROCEDURE) A 30% RIGHT PNEUMOTHORAX DEVELOPED. THE DR. STATED, THE LUNG WAS NOT PUNCTURED. THE DEVICE WAS USED FOR BOTH DIAGNOSTIC AND THERAPEUTIC TREATMENT OF PLEURAL INFUSION IN THE RIGHT PLEURAL SPACE. PNEUMOTHORAX WAS NOTED SHORTLY AFTER THE PROCEDURE. HE WAS NOT SURE WHETHER THIS WAS DUE TO ANY LEAKAGE OR DEFECT IN THE DEVICE, OR DUE TO THE PT'S OWN CONDITION. THERE WAS NO FURTHER PT COMPLICATION AS A RESULT OF THIS. THE PT SLOWLY RECOVERED WITHOUT ANY MEDICAL INTERVENTION PERFORMED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE "CLIPS WERE SPITTED FROM JAW WHEN SURGEON TRIED TO LOAD THEM." THERE WAS NO CONSEQUENCE TO THE PT. ON 9/9/96, THE CLIPS DID NOT FALL INTO THE PT.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY.
HEALTHCARE PROF REPORTED THAT WHILE TRANSPORTING THE PT TO ICU PRESSURE DROPS WERE OBSERVED. TEE REVEALED INTERMITTENT IMPINGEMENT. THE VALVE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. SURGEON NOTED THAT DURING THE PROCEDURE LONG CHORDEA HAD BEEN TRIMMED AND THAT IT WAS POSSIBLE THAT TISSUE ENTRAPMENT WAS THE CAUSE OF THE INTERMITTENT PROBLEM; ALTHOUGH ON REOP THE DISC WAS OBSERVED TO BE FREELY MOBILE.
THE HANDLES ARE BROKEN. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, THEREFORE, THIS EVENT DID NOT CAUSE ANY ADVERSE CONSEQUENCE FOR ANY PT.
SUMMARY OF EVALUATION: THIS EVENT IS THE RESULT OF REPEATED MECHANICAL AND THERMAL STRESSES. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO PRECLUDE EVENTS OF POLYMER CRACKING. F1-14: HAS BEEN COMPLETED BY THE MFR. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
DURING A DIALYSIS TREATMENT, THE FACILITY REPORTED THAT AIR/FOAM PASSED THE UABD (ULTRASONIC AIR BUBBLE DETECTOR) WITHOUT AN ALARM CONDITION. PT WAS PLACED ON LEFT SIDE. THERE WAS NO FURTHER INTERVENTION REQUIRED.
THE MEDICAL EQUIPMENT SERVICE TECH (MES) DID NOT FIND A PROBLEM WITH THE MACHINE BUT REPLACED THE UABD TRANSDUCER AS A PRECAUTION. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE RETURNED UABD ASSEMBLY WAS PLACED INTO A CALIBRATED MACHINE AND OPERATED NORMALLY. THE CHECKOUT TEST PROCEDURE 860520-003, SECTION 7 WAS IMPLEMENTED TO TEST THE UABD. A 7 UL AIR BUBBLE WAS INJECTED INTO THE TUBING TO PASS BY THE UABD. THIS TEST WAS DONE 10 TIMES AND THE UABD PASSED EVERY TEST. THE MACHINE WAS LEFT ON FOR FOUR HRS WITH THE UABD ENERGIZED AND THE TEST WAS PERFORMED AGAIN TEN MORE TIMES WITH NO DEFECTS. THEREFORE, THE REPORTED CONDITION WAS NOT DUPLICATED. SAFETY ANALYSIS: AN AIR IN BLOOD ALARM, AS DESCRIBED IN SECTION 5-11 OF THE OPERATOR'S MANUAL, VERSION 1995/10, PRODUCES A VISUAL AND A STEADY AUDIBLE ALARM. THE VENOUS CLAMP OCCLUDES THE RETURN LINE AND THE BLOOD PUMP IS STOPPED, ISOLATING THE PT FROM THE MACHINE. THE DETECTION OF FOAM OR MICROBUBBLES WITH THE AIR DETECTOR IS DISCUSSED IN FAR #960033, WHICH IS APPLICABLE TO THIS COMPLAINT. THE ABOVE TESTING INDICATES THAT THIS UABD ASSEMBLY MET MFG SPECIFICATIONS. SEE FAR #950033. CUSTOMER CONTACTED? N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N. REPORT ATTACHED? N.
THE CATHETER WAS PLACED FOR CHEMOTHERAPY. IT WAS REPORTED THAT THE CATHETER EXTENSION TUBING BURST JUST BELOW THE DISTAL END OF THE BLUE HUB. THE CATHETER WAS REMOVED AND REPLACED.
THE CATHETER WAS EXAMINED AND WAS FOUND TO BE LEAKING FROM A SMALL HOLE IN THE VENOUS EXTENSION. THE HOLE WAS JUST PROXIMAL TO THE BLUE CONNECTOR. THE CATHETER DID NOT APPEAR CLOTTED AND IT WAS SLIGHTLY DISCOLORED FROM USE. THE HOLE WAS ABOUT 1MM IN DIAMETER AND THE EDGES AROUND THE HOLE PROTRUDED OUTWARD ABOUT 1MM. THIS INDICATED THAT THE CATHETER WAS OVERPRESSURIZED, CAUSING THE HOLE.
AT THE END OF A CASE THE PT WAS PLACED ON TO AN AMBU-BAG FOR TRANSPORT. AFTER 2-3 BREATHS HE COULD NOT BE VENTILATED AND HIS BLOOD PRESSURE DROPPED. HE WAS PLACED BACK ON THE VENTILATOR, GIVEN VOLUME AND RECOVERED. IT WAS DISCOVERED THAT THE PEEP VALVE ON THE AMBU-BAG WAS SEALED SHUT.
PERFORATED COLON. PT WAS KEPT IN HOSP FOR EVALUATION FOR SURGERY.
THE PLASTIC HANDLE IS BROKEN. THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE EVENT IS ATTRIBUTED TO EXPOSURE TO REPEATED THERMAL AND MECHANICAL STRESS RESULTING FROM AUTOCLAVING AND MISUSE. HANDLE MATERIAL HAS BEEN CHANGED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THAT "BOTH CAUSED SCISSORING IN A ROW." THERE WAS NO CONSEQUENCE TO THE PT. ON 9/9/96, THE CASE WAS COMPLETED BY USING A NEW DEVICE.
RECORD PURPOSE ONLY: AS THE PACKAGE WAS NOT RETURNED FOR ANALYSIS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUALLY IMPROVE CO'S PRODUCT.
CAUTERY TIP BROKE WHILE SURGEON GETTING READY TO CLOSE CHEST. BOTH PIECES FOUND.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY AND THE JAWS SCISSORED. THE SURGEON COMPLETED WITH ANOTHER INSTRUMENT. THE HOSPITAL HAS REPORTED THAT NOO PT INJURY OCCURRED.
9/17/96 - MEDWATCH REPORT WAS NOT RRECEIVED BY MANURACTURER. SUBMITTED INITIAL REPORT.
DURING A NAILING R HIP FRACTURE, A 1" NAIL WAS DRIVEN INTO PLACE AND ON DRIVING THE INSERTION DEVICE, THE SCREWS ON THE END OF THE NAIL BROKE OFF IN THE CANNULA.
THE IMPLANT DID NOT INTEGRATE. THE DR WAS PUTTING ON THE HEALING CAP WHEN THE IMPLANT "POPPED OUT." ONE PERSON AFFECTED.
AS THE IMPLANT WAS NOT RETURNED, IT COULD NOT BE EVALUATED. CO CANNOT BE CERTAIN IT IS A CO'S PRODUCT. THE REPORTED GRANULOMA IS THE PROBABLE CAUSE OF FAILURE.
THE PEEP KEEP PLUG OF THE SWIVAL ADAPTER BECAME DISLODGED AND THE PT BECAME CYANOTIC.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FDA BY SIMS, INC. PURSUANT TO 21CFR803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AN ADMISSION BY THE CO THAT A SIMS DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE AND A REPORTABLE DEATH OR SERIOUS INJURY. NI ENTRY THROUGHOUT THE FORM - CO HAS CONTACTED THE UF ON SEVERAL OCCASIONS AND HAS NOT YET RECEIVED THIS INFO. NO REMEDIAL ACTION WAS TAKEN AS A RESULT OF THIS EVENT. CO TESTING HAS FAILED TO DUPLICATE DISLODGE CAUSED BY ANY PLAUSIBLE RANGE OF VENTILATOR PRESSURES. IT IS LIKELY THAT AN EXTERNAL FORCE EXERTED ON THE PEEP KEEP PLUG IS CAUSING OR CONTRIBUTING TO THIS EVENT. THE MAJORITY OF USERS HAVE NOT EXPERIENCED DISLODGE WHILE USING THIS DEVICE. CO DID INITIATE AN INCREASE IN THE DIAMETER OF ITS PEEP KEEP PLUG IN MAY 1996 IN RESPONSE TO PREVIOUS EVENTS. THIS CHANGE IS INCORPORATED IN CO'S CURRENT MANUFACTURING OF THIS DEVICE.
IT WAS REPORTED A BALLOON DEVELOPED A LEAK ON THE FIRST INFLATION AT APPROX FOUR-SIX ATMOSPHERES DURING A PERIPHERAL ANGIOPLASTY. NO FURTHER DETAILS REGARDING THE NATURE OF THE LESION WERE AVAILABLE. ANOTHER BALLOON CATHETER WAS USED TO AUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS NOT BEEN RETURNED FOR EVAL. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. HOWEVER, WITHOUT FURTHER DETAILS AND WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
THE CATHETER HAD SEPARATED AT THE HUB. THE CATHETER WAS REMOVED.
THE HARD LUER LOCKING HUB WAS REPLACED INTO THE SOFT MOLDED HUB FOR EVALUATION. USING A 6CC SYRINGE WITH WATER, THE CATHETER WAS PRESSURIZED UP TO 80 PSI BY OCCLUDING THE DISTAL TIP WITH A PADDED CLAMP. THE HARD HUB STAYED SECURELY IN PLACE. THIS WAS REPEATED FOR VERIFICATION, AND THE HARD HUB STILL STAYED IN PLACE. THE INSTRUCTIONS FOR USE WARN AGAINST EXERTING PRESSURES IN EXCESS OF 25 PSI. OVERPRESSURIZATION CAN CAUSE THE HARD LUER LOCKING HUB TO SEPARATE FROM THE CATHETER.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED THE DEVICES JAMMED. THE DEVICES WERE NOT SAVED. THE CASE WAS COMPLETED WITH A THIRD DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D10: CONTACTED FACILITY, INFORMATION NOT PROVIDED. D5,6; H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
PEEP VALVE PLACED ON INSPIRATORY SIDE OF VENTILATOR PREVENTING OXYGENATION OF PT FOR APPROX 10 MINS.
IMPLANT DID NOT INTEGRATE. IT WAS PLACED 5/10/96. ONE PERSON AFFECTED.
THE IMPLANT WAS RETURNED FOR EVALUATION AND FOUND TO BE CLEAN AND TO MEET SPECIFICTIONS, CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
DURING CIRCUMCISION, TIP OF PENIS WAS CUT OFF. TIP WAS REATTACHED WITH SURGICAL INTERVENTION. THE CLAMP USED HAS A OPENING OF 7-8 MM AND NEWER MODELS HAVE AN OPENING OF ABOUT 3 MM, THUS REDUCING THE RISKS OF INJURY. ALL OF THESE MFR'S CLAMPS HAVE BEEN PERMANENTLY REMOVED FROM SVC.
DURING A DIALYSIS TREATMENT, THERE WAS AN EXTERNAL BLOOD LEAK FROM THE SEALING PLUG ABOVE THE LABEL. BLOOD LOSS WAS ESTIMATED AT 15CC. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A REVIEW AND INVESTIGATION OF THE PROCESS EQUIPMENT USED TO MANUFACTURE THE PLUG AS WELL AS THE PLUGGING STATION IN THE DIALYZER ASSEMBLY LINE WERE DONE TO FIND POSSIBLE REASONS FOR DEFECTS OR SMALL DAMAGES TO THE SEALING PLUG WHICH OCCASIONALLY MAY CAUSE LEAKAGE. THE PLUGGING STATION DESIGN WAS REVIEWED AND A SMALL CHANGE WAS DONE TO THE PLUG ENTRANCE CHANNEL TO FACILITATE THE MOVEMENT OF THE PLUG AND AVOID RANDOM DAMAGES. THE ACTIVITIES ON THE PLUGGING STATION WERE DONE ON 10-3-96. THE ADJUSTMENTS OF THE COMPLETE PLUGGING STATION HAVE EARLIER BEEN RECHECKED ON 8-9-96. AS PART OF CONTINUING IMPROVEMENT PROGRAM THE MOULDING TOOL FOR THE PLUG WAS POLISHED TO AVOID ANY OCCURRENCE OF SURFACE ROUGHNESS. THIS ACTION IMPLEMENTED 9-2-96 WILL FACILITATE THE MOVEMENT OF THE PLUG IN THE PLUG STATION AND REDUCE ANY POSSIBILITIES FOR RANDOM DAMAGES TO THE PLUG. CUSTOMER CONTACTED:N. SALES/ SERVICE ONTACTED BY INVESTIGATOR:N. TRAINING REQUIRED:N.
GAS ALARM ON H8000, PUMP RESTARTED, BLOOD INTRAINED BACK INTO PUMPIABP THERAPY CEASED. IAB REMOVED, PT STABLE NOT REQUIRING FURTHER IABP THERAPY. IAB WAS DISCARDED AT HOSP.
H-10 SECTION H3 NO SAMPLE AVAILABLE H-11-ALL UNK AND BLANKS INFO REQUESTED BUT NOT REC'D H-11 SECTION F10 DEVICE CODE 1746 LABELED. H-11 SECTION F PROVIDED BY MANUFACT.
THE PRODUCT WAS APPLIED DURING A MIDLINE CLOSURE. REPORTEDLY, THE SUTURE BROKE, THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SUTURE. THE HOSPITAL HAS REPORTED THAT NO PT UNJURY OCCURRED.
9/17/96 - MEDWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
DR REPORTED FAILED IMPLANT. IT WAS PLACED 6/29/96 AND REMOVED 6/6/96. ONE PERSON AFFECTED.
THE RETURNED IMPOLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. THE PT'S SMOKING IS THE PROBABLE CAUSE OF FAILURE.
THE PHYSICIAN REPORTED "SPASTIC VIBRATION" OF THE DRILL MOTOR, WHICH IN TURN CAUSED THREE DURA TEARS TO THE PT. THE TEARS IN THE DURA WERE REPAIRED DURING THE COURSE OF THE SURGERY. THE PT WAS DOING FINE; NO FURTHER INFO WAS AVAILABLE.
THE EXPECTED FREQUENCY OF THIS TYPE OF INCIDENT IS VERY LOW. THIS IS AN ISOLATED INCIDENT FOR THE NUMBER OF CO PNEUMATIC DRILL MOTORS IN USE ON A DAILY BASIS WORLD WIDE. THE PNEUMATIC DRILL MOTOR IS SUCCESSFULLY BEING USED IN THE HEALTH CARE INDUSTRY FOR A VARIETY OF APPROVED APPLICATIONS, WITH A RECORD OF SUCCESS. THIS TYPE OF OCCURRENCE CAN BE AND IS USUALLY ATTRIBUTED TO THE AGE OF THE DEVICE AND THE MAINTENANCE CARE PROGRAM FOLLOWED BY THE USER FACILITY. THE MOTOR AND ATTACHMENT IN THIS CASE HAVE NOT BEEN RETURNED FOR EXAM. ONCE THE EQUIPMENT HAS BEEN REPAIRED, A FULL MAINTENANCE REPAIR REPORT IS SENT TO THE USER FACILITY. THE SEVERITY OF THIS TYPE OF INCIDENT IS UNPREDICTABLE. HOWEVER, THE PT IN THIS CASE WAS REPORTED TO BE DOING FINE AFTER SURGERY, AND NO ADD'L INFO WAS AVAILABLE AT THE TIME OF THIS REPORT. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE USER FACILITY, MANUFACTURER, OR PRODUCT CAUSED THE EVENT. THIS REPORT CONTAINS INFORMATION REPORTED TO CO AND MAY NOT CONTAIN CO REPRESENTATION OF THE FACTS AFTER FURTHER INVESTIGATION. NEITHER THE SUBMISSION OF THIS NOR OTHER INFORMATION TO THE FDA, NOR PUBLIC RELEASES OF SUCH INFORMATION, CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED, OR ESTABLISHES THE EXISTENCE OF ANY CASUAL CONNECTION BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY. ADD'L INFO WILL BE SUBMITTED IF IT BECOMES AVAILABLE.
BALLOON INSERTED ON 9/15/96 AT 18:10 PM. AN LVAT WAS INSERTED ON 9/17/96 PT'S CHEST WAS OPENED ON 9/19. BLOOD WAS OBSERVED IN TUBING. BALLOON WAS REMOVED AND REPLACED. LVAT AND 2ND BALLOON WERE DISCONTINUED 9/20. PT CREATINE 2.5. HOSP HAS NOT RELEASED PRODUCT.
H-11-ALL UNK INFO REQUESTED BUT NOT REC H-11 SECTION F PROVIDED BY MFG H-11 SECTION F-10 DEVICE CODE 1746 LABELED. H-11 SECTION H3 CODE 81 HOSP NOT RELEASING THE IAB.
IMPLANT FAILED. DATE OF OCCURRENCE IS UNK. ONE PERSON AFFECTED.
THE CAUSE OF FAILURE IS LIKELY THE PT'S SMOKING, COMPOUNDED BY HER HYPERTENSIVE CONDITION.
THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED THE SURGEON FIRED THE DEVICE AND THEN SWITCHED TO BLUE CARTRIDGE FOR SECOND FIRING. THE INSTRUMENT DID NOT FULLY FIRE AND DID NOT CUT. A SECOND DEVICE WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,4,B6,7,D5,10-INFORMATION WAS NOT PROVIDED. H6-CODE 400: DAMAGED FIRING MECHANISM. BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. THE RETURNED CARTRIDGE WAS MISSING THE LOCKOUT TAB AND MIDDLE ALIGNMENT FINGER. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
AFTER DILATATION IN A VERY TORTUOUS AND HIGHLY CALCIFIED MARGINAL, THE PHYSICIAN DID NOT SUCCEED IN WITHDRAWING THE STEERABLE (GUIDEWIRE) THAT BLOCKED IN AN ATHEROMA PLAQUE AND FINALLY BROKE. THE PHYSICIAN TRIED TO RETRIEVE THE LOST PART WITH A TRAVERSE GW FROM ANOTHER CO WITHOUT SUCCESS.
FOLLOWING SUCCESSFUL BALLOON DILATATION OF A VERY TORTUOUS MARGINAL ARTERY, THE GUIDEWIRE BECAME STUCK IN THE ARTERY. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE GUIDEWIRE WITH A COMPETITOR'S WIRE, BUT WAS UNSUCCESSFUL, AS IT WAS NOT POSSIBLE TO REACH THE DISTAL TIP BECAUSE OF THE TORTUOSITY OF THE ARTERY. THE PHYSICIAN THEN PULLED BACK WITH A GREAT FORCE AND THE GUIDEWIRE FRACTURED. THE FRACTURED DISTAL PORTION REMAINED WITHIN THE MARGINAL ARTERY. THE PT'S CONDITION WAS REPORTED AS STABLE ON MEDICATION. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT. VISUAL EXAMINATION: THE GUIDEWIRE'S DISTAL END WAS NOTED TO BE FRACTURED. THE DISTAL GUIDEWIRE FRACTURE SEGMENT WAS NOT RETURNED. MICROSCOPIC EXAM: LIGHT OPTICAL EXAM OF BOTH THE COREWIRE AND COILWIRE REVEALED THE UNIT TO BE FRACTURED. THE FRACTURED COREWIRE END WAS FOUND TO BE EXTENDING DISTALLY PAST THE BLACK PTFE SLEEVE 3MM, AND THE COILWIRE SLIGHTLY MORE DISTAL THAN THE COREWIRE. TOTAL LENGTH OF GUIDEWIRE MEASURED 177.5 CM. FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) ON BOTH THE FRACTURED GUIDEWIRE AND COILWIRE ENDS REVEALED EVIDENCE OF A CIRCULAR ARRAY ON THE FRACTURE SURFACE WITH A TRANSVERSE FRACTURE PLANE ON BOTH FRACTURED ENDS. IT IS BELIEVED THAT BOTH THE COREWIRE AND COILWIRE FRACTURED DUE TO TORSIONAL OVERLOADING. THERE WERE NO INDICATIONS OF ANY MATERIAL DEFECTS.
THE PRODUCT WAS APPLIED DURING A MIDLINE CLOSURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SUTURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/17/96 - METWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITED INITIAL REPORT.
DR STATES PERIODIC "SPASTIC VIBRATION" OF DEVICE CAUSED DURAL TEARS X 3.
PT MEDICAL HISTORY HAS BEEN REVIEWED. CONCLUSION REMAINS THE SAME AS PREVIOUSLY REPORTED.
IMPLANT FAILED-MOBILITY. DATE OF OCCURRENCE IS UNK.
BLOOD WAS SEEN IN TUBING ON 9/18/96. BALLOON WAS EXPLANTED. ANOTHER IAB INSERTED BUT COULD NOT PUT IN, HAD PROBLEMS. WAITED TWO DAYS AND SUCCESSFULLY INSERTED THE IAB. THIS IAB WAS DISCONTINUED AFTER AN UNDERTERMINED AMOUNT OF TIME. PT EXPIRED DUE TO ILLNESS.
H-11 ALL UNK INFO REQUESTED BUT NOT REC H-11 SECTION F PROVIDED BY MANUFACT. H11 SECTION F10 DEVICE CODE 1746 LABLED.
THE PRODUCT WAS APPLIED DURING A MIDLINE CLOSURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SUTURE. THE HOSPITAL HAS RREPORTED THAT NO PT INJURY OCCURRED.
IMPLANTED CATHETER PLACED ON 7/18/96 FOR IVAB THERAPY. DURING IVAB TX, THE PT C/O PAIN, SWELLING AND EXTRAVASATION AT PORT SITE. THE CATHETER WAS REPLACED ON 9/30/96 DUE TO PINHOLE LEAK IN THE CATHETER UNDER THE CONNECTION SLEEVE.
THE VALVE WAS IMPLANTED THREE WEEKS AGO. THE PT RETURNED TO SEE THE PHYSICIAN, COMPLAINING OF HEADACHES AND IT WAS DISCOVERED THAT HE HAD BILATERAL SUBDURAL HEMATOMA. THE VALVE HAS NOT BEEN REMOVED YET, DOCTOR HAS NOT MADE THIS DETERMINATION YET.
REPORT RECEIVED FROM THE FILED INDICATED THAT THE VALVE WAS EXPLANTED ON OR ABOUT 1/24/97, AND REPLACED UNEVENTFULLY WITH A DELTA II VALVE. THE PATIENT'S CONDITION WAS REPORTED AS SATISFACTORY POST-OP. THE PRODUCT IS TO BE RETURNED TO CORDIS FOR EVALUATION AND TESTING, BUT HAS NOT YET BEEN RECEIVED. PLEASE NOTE DATE OF 3/26/97 FOR SUBMISSION OF SUCH INFO PENDING THE PRODUCT RETURN AND COMPLETION OF THE ANALYSIS.
HEMOSTATIC VALVE ON INTRODUCER CATHETER IS DEFECTIVE. NOT ONLY DID IV FLUIDS AND BLOOD LEAK OUT, BUT IT ALMOST ALLOWED AN AIR EMBOLUS.
TWO IMPLANTS FAILED TO INTEGRATE. NO FURTHER INFO HAS BEEN RECEIVED. ONE PERSON AFFECTED.
NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANTS ARE NOT BELIEVED TO BE THE CAUSE OF FAILURE.
THE DEVICE WAS NOT CLINICALLY APPLIED. REPORTEDLY, THE NEEDLE BROKE OUTSIDE THE PT'S CAVITY.
9/17/96 - METWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT TO FDA.
DURING A THORACOTOMY, A STAPLER WAS USED TO RESECT A PULMONARY ARTERY. AFTER THE STAPLER WAS FIRED, THE HANDLE COULD NOT BE OPENED TO RELEASE THE JAWS OF THE STAPLER. THE STAPLER'S JAWS WERE STUCK IN THE PERICARDIUM AND COULD NOT BE REMOVED. THE CO WAS CONTACTED BY PHONE FROM THE OR. MD CONFERRED WITH THEM AND TROUBLESHOT THE STAPLER. THE STAPLER WAS REMOVED.
AFTER PLACEMENT OF THE CATHETER IN RIGHT SUBCLAVIAN THE PHYSICIAN ATTEMPTED TO FLUSH THE CATHETER WITH SALINE AND NOTICED THERE WAS A HOLE IN THE CATHETER NEXT TO THE VITA CUFF WHERE A PLASTIC CLAMP WAS PLACED DURING PACKAGING. THE CATHETER HAD TO BE REMOVED AND REPLACED. ORIGINAL DIAGNOSIS AND PROCEDURE WAS LYME DISEASE AND INSERTION R SUBCLAVIAN CATHETER. THIS WAS AN OUTPT PROCEDURE.
THE DEVICE WILL NOT ENHANCE UNDER PRESSURE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, THEREFORE, THIS EVENT DID NOT CAUSE ANY ADVERSE CONSEQUENCE FOR ANY PT.
SUMMARY OF EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED NO DISCREPANCIES. A FUNCTIONAL CHECK OF THE CEMENT GUN INDICATED THAT THE DEVICE WAS FULLY FUNCTIONAL. THE COMPLAINT COULD NOT BE VERIFIED. F1-14: HAS BEEN COMPLETED BY THE MFR. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
PT UNDERGOING ENDOSCOPY. AFTER PROCEDURE COMPLAINED OF ABDOMINAL PAIN AND DISTENTION. X-RAYS AND CT SCAN DID NOT DEMONSTRATE ANY DEFINITIVE PERFORATION. PT CONTINUED TO BE SYMPTOMATIC. TO SURGERY FOR EXPLORATORY LAPAROTOMY. PERFORATION NOTED AND SURGICALLY REPAIRED.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL, PRE-EXPOSURE, LOADING OF THE IMPLANT, MICROMOVEMENT OF THE IMPLANT FROM THE TEMPORARY PROSTHESIS AND INSUFFICIENT BONE QUANTITY AS CAUSES FOR FAILURE. THIS FILE IS CLOSED.
RIGHT INTERNAL JUGULAR LINE PLACED. CATHETER APPEARED TO BE IN THE RIGHT CAROTID. CATHETER DISCONTINUED. PT AWAKENED FROM ANESTHESIA. NEGATIVE NEUROLOGICAL EXAMINATION. RIGHT ARTERIOGRAM PERFORMED WITH NEGATIVE RESULTS. ANESTHESIA BEGUN AND OPERATIVE PROCEDURE PERFORMED WITHOUT COMPLICATIONS.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUANTITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
PT WAS STATUS-POST RESECTION OF ABDOMINAL MASS AND ADRENALECTOMY; EPIDURAL CATHETER PLACED AT TIME OF SURGERY 10/17/96. EPIDURAL MEDS DISCONTINUED. CATHETER WAS REMOVED PER PROTOCOL. ON INSPECTION, A PORTION OF THE DISTAL CATHETER WAS NOTICED TO BE MISSING. X-RAY REVEALED A PORTION OF THE CATHETER RETAINED IN THE SOFT TISSUE AT L1-2. THE PT WAS RETURNED TO THE OR FOR EXPLORATION AND REMOVAL OF FOREIGN BODY. RECOVERED CATHETER SECTION WAS ABOUT 7 CM IN LENGTH.
THE BALLOON BURST ON THE 4TH INFLATION USING A 10CC SYRINGE.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED A LEAK SOURCE, APPROXIMATELY 3.4 CM AT THE DISTAL END. MICROSCOPIC EXAMINATION: FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE. ABRASIONS ADJACENT AND INTERSECTING THE LEAK SOURCE. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION. FURTHER, A FULL LENGTH AXIAL TEAR IS INDICATIVE OF INFLATION IN EXCESS OF THE RATED BURST PRESSURE.
INVESTIGATION CONDUCTED. DR CITES SURGICAL TRAUMA AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED THE DEVICE MISFIRED. THE INSTRUMENT WAS GIVEN TO THE BUYER WITH NO ADD'L INFO. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "MISFIRED" DURING SURGERY. THE INSTRUMENT WAS RETURNED WITH A BENT KNIFE, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. NO CONCLUSION COULD BE REACHED AS TO HOW THE KNIFE HAD BECOME BENT. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSSEMBLY PROCESS TO ENSURE IF FUNCTIONS PROPERLY.
A 60-YR-OLD MALE PT WITH A TEXAS CATHETER WAS FOUND TO HAVE PENILE SWELLING. THE CATHETER WAS REMOVED AND THE SWELLING ADVANCED. A UROLOGIST EXAMINED THE PENIS AND NOTED THERE APPEARED TO BE SUPERFICIAL SKIN LOSS POSSIBLY SECONDARY TO ISCHEMIC CHANGES IN THE LOWER PORTION OF THE PT'S PENIS. IN THAT THE SKIN SLOUGHING WAS SIMILAR TO A SECOND DEGREE BURN IT IS BEING TREATED AS A SECOND DEGREE BURN. THE TEXAS CATHETER HAD BEEN WORN MOST OF THE TIME BY THE PT FROM 9/28/96 THROUGH 10/17/96. THE DAILY PERINEAL CARE INCLUDED WASHING THE PT'S PENIS WITH SOAP AND WATER RINSING THEN USING A PERINEAL CLEANING SOLUTION, THEN RINSING WITH WATER AND ALLOWING TO DRY. THE TEXAS CATHETER WAS WASHED WITH SOAP AND WATER THEN RINSED WITH WATER. AFTER THIS THE CATHETER WAS REAPPLIED. THE LAST TIME PERINEAL CARE WAS DONE WAS ON 10/16/96, SEVERAL HRS BEFORE THE SWELLING WAS IDENTIFIED.
CERAMIC TIP OF RESECTOSCOPE INNER SHEATH REPORTEDLY DISLODGED DURING A PROCEDURE.
NO APPARENT PRODUCT ANOMALIES. INSUFFICIENT INFO TO DETERMINE PRECISE CAUSE OF THE PROBLEM. A POSSIBLE CAUSE IS THAT THE TUBE WAS DEFLECTED WHILE THE CERAMIC TIP WAS RESTRICTED MULTIPLE TIMES, ULTIMATELY CAUSING A SHEARING OF THE BOND AND REDUNDANT FASTENING INDENTS; RESULTING IN TIP SEPARATION.
FLUOROSCOPY TABLE MALFUNCTIONED CAUSING PT TO SLIDE OFF FOOT END OF TABLE STRIKING HIS HEAD. PT ALSO SUSTAINED LACERATIONS. TREATED IN ER AND RELEASED.
A1,2,3,4;B6,7;D10: INFORMATION NOT PROVIDED BY AFFILIATE. D5,6;H4,6: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
9/9/96 DR. COULD STAPLE BY USING A NEW PRODUCT, NO INTERVENTIONS WERE REQUIRED.
X-TUBE ASSM 18X16. DEALER CLAIMS X-TUBE BROKEN AT CENTER PIVOT HOLE ON LEFT SIDE.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN THROUGH MEANS OF A LETTER, HE REPORTED THAT THE PT IS EXPERIENCING "DIFFICULTY IN DEFLATING THE PROSTHESIS WITH A DEFORMITY IN THE PENIS. ON PHYSICAL EXAMINATION, THE PENIS WAS NOTED TO BE ERECT WITH BALLOONING OF THE PROXIMAL SHAFT. THE PUMP WAS IN THE RIGHT BASE SCROTUM AND WAS UNABLE TO DEFLATE THE CYLINDERS EVEN WITH MODERATE PRESSURE ON THE CYLINDERS WITH THE RELEASE VALVE OPENED. CO'S IMPRESSION IS A MALFUNCTION OF THIS DEVICE WITH PROBABLE CONTRACTION OF THE CAPSULE AROUND THE RESERVOIR WITH SUBSEQUENT BALLOONING OF ANEURYSMAL DILATION OF THE PENILE CYLINDER.
CAPSULAR FORMATION AND CONTRACTURE IS A KNOWN INHERENT RISK ASSOCIATED WITH ANY FOREIGN OBJECT IMPLANTED IN THE BODY. TO DATE, NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN REPORTED. THEREFORE, QA IS PRECLUDED FORM DETERMINING THE EXACT CAUSE AND WILL ACCEPT THE PHYSICIAN'S DIAGNOSIS. SHOULD THE STATUS OF THIS PT CHANGE WITH REGARD TO THIS EVENT, AN ADDENDUM TO THIS REPORT WILL BE FILED.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. REPROTEDLY, THE STAPLE LINE WAS INCOMPLETE AND BLEEDING WAS OBSERVED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRRED.
X-TUBE ASSEMBLY 18"X18". DEALER CLAIMS X-TUBE BROKEN AT CENTER BOLT.
HIGH STESS FACTOR AT CENTER AND ENDS OF X-TUBE.THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT ARRIVED IN THE OR FOR SURGEON TO REMOVE BILATERAL RUPTURED BREAST IMPLANTS. SURGEON THEN REPLACED THESE WITH NEW BILATERAL IMPLANTS.
THE FACILITY DOES NOT KNOW THE LOCATION OF THE DEVICE, SO AN EVAL OF THE DEVICE IS NOT POSSIBLE . A REVIEW OF THE DEVICE HISTORY AND THE COMPLAINT HISTORY INDICATED NO RELATED MFG ISSUES AND NO OTHER COMPLAINTS FOR THIS LOT.
INVESTIGATION CONDUCTED. DR CITES CAUSE  FOR FAILURE AS UNKNOWN. THIS FILE IS CLOSED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE SAFETY SHIELD DID NOT FUNCTION PROPERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
10/09/96- SUPPLEMENTAL REPORT SUBMITTED TO FDA BY MFG. ADDITIONAL INFORMATION DATA SUBMITTED FOR A-3, D-7, D-8, D-9 AND E-1. EVALUATION INDICATED AND CODES ENTERED ON H-3 AND H-6. SUMMARY OF RESULTS: THE DEVICE DISPLAYED DAMAGE INCURRED DUE TO EXPOSURE TO EXCESSIVE HEAT. THE SAFETY SHIELD CANNOT BE ACTIVATED DUE TO THE DISTORTION CAUSED BY THE HEAT, HOWEVER, THE SAFETY SHIELD DOES FUNCTION PROPERLY WHEN ACTIVATED MANUALLY. THE HEAT DAMAGE HAS BEEN ATTRIBUTED TO THE USER EXPOSING THE DEVICE TO ELEVATED TEMPERATURE.
PT HAD REMOVAL OF BILATERAL BREAST IMPLANT IN SURGERY. BOTH IMPLANTS HAD RUPTURED.
BLOOD WAS NOTICED IN THE IAB CATHETER, AND A BALLOON CHECK CATHETER WAS REMOVED AND A HOLE WAS VISIBLE IN THE PROXIMAL END OF THE BALLOON. PT IS STABLE WITHOUT IAB SUPPORT, NO APPARENT COMPLICATIONS.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY & QUANTITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
9/3/96 PT UNDERWENT TURP AND REMOVAL OF A CATHETER. 9/4/96 - EQUIPMENT DETERMINED TIP BROKEN. RETURNED TO MFR. 10/12/96 - PT RETURNED TO OR FOR REMOVAL OF A FOREIGN BODY (PLASTIC TIP OF THE RESECTOSCOPE).
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN, THE DEVICE WAS REMOVED DUE TO "INFECTION." AS REPORTED TO CO BY MEANS OF OPERATIVE NOTES "HE DEVELOPED A LOCALIZED INFECTION AROUND THE PUMP IN THE SCROTUM. DR TRIED TO MANAGE THIS WITH ANTIBIOTICS, HOWEVER IT DID NOT IMPROVE. DR THEN REMOVED THE SCROTAL PUMP TWO WEEKS AGO. DR DID NOT SEE ANY PURULENCE COMING FROM THE CYLINDER AND THEREFORE ELECTED TO TRY TO SALVAGE THEM. THE PT HAS HAD CONTINUED DRAINAGE FROM HIS WOUND INDICATING OBVIOUS CONTINUED INFECTION." DR ELECTED TO BRING HIM BACK TO THE OPERATING ROOM FOR REMOVAL OF THE CYLINDER(S) AND RESERVOIR."
IN THE RECEIVED INFO THE PHYSICIAN STATED THAT THE PT "INITIALLY DEVELOPED A LOCALIZED INFECTION AROUND THE PUMP IN THE SCROTUM. DR TRIED TO MANAGE THIS WITH ANTIBIOTICS, HOWEVER, IT DID NOT IMPROVE. DR THEN REMOVED THE SCROTAL PUMP TWO WEEKS AGO. HE DID NOT SEE ANY PURULENCE COMING FROM THE CYLINDERS AND THEREFORE ELECTED TO TRY TO SALVAGE THEM. THE PT HAS CONTINUED TO HAVE DRAINAGE FROM HIS WOUND INDICATING OBVIOUS CONTINUED INFECTION. DR ELECTED TO BRING HIM BACK TO OPERATING ROOM FOR REMOVAL OF THE CYLINDERS." THE RESERVOIR WAS ALSO REMOVED. CULTURES TAKEN DURING SURGERY REVEALED THE PRESENCE OF PSEUDOMONAS AERUGINOSA. QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PRECLUDED FROM COMMENTING ON THE CONDITION OF THE PROSTHESIS. SHOULD THE EXPLANTED DEVICE BECOME AVAILABLE, OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. HOWEVER, BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION. QA ACCEPTS THE REPORT OF INFECTION BASED ON THE PHYSICIAN'S OBSERVATIONS. THE REVIEW OF THE DEVICE  LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE.
THE INSTRUMENT WAS USED DURING A LOW ANTERIOR RESECTION. IT WAS REPORTED AS SURGEON WAS FORMING DISTAL TRANSECTION LINE HE NOTICED THE STAPLER MALFORMED THE LATERAL 1/3 RD OF STAPLE LINE. THAT COMPROMISED AREA WAS THE END CLOSEST TO RETAINING PIN. SURGEON HAD TO PULL RECTUM OUT OF ANUS AND HAND SEW THE AREA. SURGEON REPORTED THE RECTUM WAS CLEANED OFF VERY WELL AND THERE WAS NOT TOO MUCH TISSUE IN THE INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION; BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING WITH REGARD TO STAPLES FIRING AND FORMING. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION AND WAS EXAMINED AND WAS FOUND TO MEET DESIGN SPECIFICATIONS. THE INSTRUMENT WAS RELOADED, CYCLED, FIRED, AND FORMED ALL STAPLES WITHOUT INCIDENT. THE STAPLES WERE MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT "MALFORMED THE LATERAL 1/3RD OF STAPLE LINE" DURING SURGERY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FIRE AND FORM CORRECTLY. THE STAPLES MAY NOT FORM PROPERLY AND LEAKAGE OF THE STAPLE LINE MAY OCCUR IF THE INSTRUMENT IS CLOSED ONTO TISSUE WHICH IS THICKER THAN THE RECOMMENDATION FOR PROPER OPERATION.
INFECTION AT SITE OF IMPLANTED CATHETER PROMPTED EXPLANTATION.
INVESTIGATION CONDUCTED. DR CITES POOR ORAL HYGIENE WHICH CAUSED AN INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
NURSE NOTICED BLOOD IN CATHETER AND A BALLOON CHECK CATHETER ALARM CONDITION FOLLOWED PERFUSIONIST WAS CALLED IN TO CONFIRM THE RUPTURE. BALLOON WAS REMOVED AND A HOLE WAS VISIBLE AT PROXIMAL END. PT IS STABLE W/O AN IAB SUPPORT, NO APPARENT COMPLICATION.
H-11 ALL UNK INFO REQUESTED BUT NOT REC H-11 SECTION F10 DEVICE CODE LABEL.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE SAFETY SHIELD DID NOT FUNCTION PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE.
10/9/96- SUPPLEMENTAL REPORT SUBMITTED TO FDA BY MFG. ADDITIONAL INFORMATION DATA SUBMITTED FOR D-7, D-8, D-9, D-10 AND E-1. EVALUATION INDICATED AND CODES ENTERED ON H-3 AND H-6.
RUPTURED SILICONE BREAST IMPLANT. REMOVED FROM LEFT BREAST.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE PT IS EXPERIENCING "FAILURE OF HIS DEVICE." A MORE SPECIFIC DEFINITION OF THE REPORTED "FAILURE" WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
NO SERIOUS INJURY, MEDICAL OR SURGICAL INTERVENTION HAS OCCURRED AS OF THE DATE OF THIS REPORT. A REQUEST HAS BEEN MADE TO THE PHYSICIAN'S OFFICE FOR ADD'L INFO AND ANY CHANGE IN THE STATUS OF THE PT OR DEVICE WITH REGARS TO THIS OCCURRENCE. SHOULD ADD'L INFO BE RECEIVED, QA WILL FILE AN ADDENDUM TO THIS REPORT.
WHEN TRANSFERRING TO WHEELCHAIR FROM VAN, X-TUBE BROKE AT CENTER PIVOT LOCATION. END USER FELL TO GROUND AND HIT HIS SHOULDER. MEDICAL ATTENTION WAS NOT SOUGHT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, IN. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
APPROX 13 HOURS AFTER IAB INSERTION, THE IAB PUMP ALARMED. INSPECTION FOUND BLOOD IN THE HELIUM LINE. THE BALLOON CATHETER WAS REMOVED. NO REPLACEMENT WAS PERFORMED. PT IS OK.
DURING AN ATTEMPT TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY, THE STENT DISLODGED FROM THE BALLOON CATHETER. THE STENT EMBOLIZED TO AN UNKNOWN LOCATION. NO REMEDIAL ACTION WAS PERFORMED. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
VISITING NURSE VISITED HOME BECAUSE PT'S WIFE CALLED AND REPORTED CATHETER HAD FALLEN OUT. WIFE REPORTED SHE WENT TO FLUSH LINE AND FLUID SQUIRTED OUT OF END. NURSE NOTED THE IV DRESSING WAS LOOSE AND DRIED BLOOD WAS AT THE INSERTION SITE. NURSE NOTED EXTERNAL HEPLOCK CAP AND TUBING WITH THE BLUE RECTANGULAR BOX LAYING ON THE SKIN. NO EVIDENCE OF INTERNAL CATHETER COULD BE SEEN. INSERTION SITE WAS SLIGHTLY FIRM. PT WAS SENT TO NEAREST HOSP ER WITH INSTRUCTION TO KEEP ARM STRAIGHT AND STILL. PT WAS REFERRED TO SEE A SURGEON THE FOLLOWING DAY FOR REMOVAL OF THE CATHETER. HOWEVER, THE CATHETER HAD MIGRATED AND PT REQUIRED RETRIEVAL OF CATHETER THROUGH THE FEMORAL ARTERY.
PER THE INFO PROVIDED TO CO BY THE HOSP, THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION." AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED.
EVALUATION IS PENDING DECONTAMINATION, EXAMINATION AND TESTING OF THE RETURNED DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVALUATION WILL BE FORWARDED UPON COMPLETION.
THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. THE "CARTRIDGE FELL INTO PT." THE SURGEON DELT WITH THE SITUATION BY CHANGING CARTRIDGE OR INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
CONCLUSION: BASED UPON THE INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE CARTRIDGE REPORTEDLY "FELL INTO THE PATIENT" DURING SURGERY. THE INSTR. WAS RETURNED IN GOOD PHYSICAL CONDITION. INSTR. A WAS RETURNED WITH DRIED TISSUE AROUND THE KNIFE BLADE. INSTR. B WAS RETURNED IN GOOD PHYSICAL CONDITION. INSTR. A WAS CYCLED, FIRED AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION, BUT HAD A ROUGH CUT DUE TO THE DRIED TISSUE ON THE KNIFE BLADE. INSTR. B WAS CYCLED, FIRED, CUT AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE CARTRIDGE RETENTION FEATURE WAS MEASURED FOR BOTH INSTRS. AND WAS FOUND TO BE WITHIN SPECIFICATION. THE INSTRS. WERE DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRS. WERE FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. COMMENTS: EACH INSTRUMENTS IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
PT HAD AN IAB PLACED AFTER SURGERY ON 9/10/96. ON 9/11/96 THE PUMP ALARMED. THE PERF WAS CALLED AND AFTER INSP. OF THE SYSTEM BLOOD WAS FOUND IN THE HELIUM LINE OF THE CATH. THE BALLOON WAS REMOVED BY THE PHYSICIAN ON HAND NO OTHER BALLOON WAS INSERTED. PT IS FINE.
H-10 SECTION F PROVIDED BY DISTRIBUTOR H-11-ALL UNK INFO REQUESTED NOT REC H-11 SECTION F10 DEVICE CODE 1746 LABELED.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL PRE-EXPOSURE LOADING OF IMPLANT AND INSUFFICIENT BONE QUALITY/QUANTITY AS CAUSES FOR FAILURE. THIS FILE IS CLOSED.
VISIT MADE TO PT RESIDENCE. PT STATED IV SITE LEAKED THE DAY BEFORE SITE ASSESSED, DRESSING REMOVED, HUB INTACT BUT CATHETER MISSING. PT SENT TO ER, X-RAY REVEALED CATHETER IN PULMONARY ARTERY. PLAN TO HAVE REMOVED VIA CATHETERIZATION.
AN ENDOVASCULAR STENT WAS SUCCCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PT'S RENAL ARTERY. UPON WITHDRAWAL OF THE DELIVERY SYSTEM IT WAS NOTED THAT THE PROXIMAL HALF OF THE BALLOON WAS NOT ATTACHED. NO FURTHER ACTIONS WERE PERFORMED. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN BILIARY PROCEDURES, ONLY.
QR AXLE W/NUT. DEALER STATES THERE IS A BROKEN AXLE CAME APART.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS APPLIED DURING A VATS LOBECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NOT PT INJURY OCCURRED.
9/17/96 - METWATCH WAS NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
PER THE INFO PROVIDED TO CO THROUGH INTERNATIONAL REP, THE DEVICE WAS REMOVED DUE TO A "RUPTURE". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED.
TWO CYLINDERS, THE RESERVOIR, AND THE PUMP WITH AN ATTACHED CONNECTOR WERE RECEIVED. A PORTION OF TUBING BETWEEN THE SERIALIZED OUTLET AND CYLINDER #1 WAS NOT RECEIVED. THE RECEIVED COMPONENTS WERE EVALUATED BY THE MFR. DURING FUNCTIONAL TESTING A LEAK WAS OBSERVED IN THE RESERVOIR TUBING, NEAR THE DISTAL END. FUNCTIONAL TESTING OF THE PUMP AND CYLINDER #1 WAS PERFORMED WITH THE PUMP ATTACHED TO CYLINDER #1. THE PUMP FAILED THE LEAKAGE PRESS, AND THE INLET VALVE TESTS.  NO LEAKAGE WAS OBSERVED IN EITHER TEST, HOWEVER, THE SPECIFIED PRESSURE WAS NOT REACHED. ADDITIONALLY, NO LEAKS WERE OBSERVED IN THE PUMP WHEN THE PUMP WAS SUBJECTED TO AIR PRESSURE. THE PUMP ALSO FAILED THE BACK PRESSURE TEST, INDICATING A VALVE MALFUNCTION. MICROSCOPIC EXAMINATION OF THE COMPONENTS WAS PERFORMED. THE PUMP'S SERIALIZED OUTLET SHOWED CROSS SECTIONAL SURFACES THAT WERE ROUGH AND IRREGULAR, INDICATING TUBING TEAR. THE RESERVOIR TUBING AHD FOUR SEPARATION/LEAKAGE SITES. TWO OF THE SEPARATIONS WERE "V" SHAPED. THE OTHER TWO WERE MORE RECTANGULAR SHAPED. THE "V" SAHPED SEPARATION SITES WERE APPROXIMATELY THE SAME SIZE AND DISTANCE APART AS THE MORE RECTANGULAR SHAPED SEPARATIONS. THE CROSS SECTIONAL SURFACES OF THESE SEPARATION SITES PROVIDED NO INDICATIONS TO THE CAUSE OF THESE SEPARATION SITES. BASED ON THE RECEIVED INFO AND QUALITY ASSURANCE'S (QA) EVALUATION, QA CONCLUDES THE FOLLOWING. A TUBING TEAR OCCURRED AT THE PUMP'S SERIALIZED STRAIN RELIEF. THIS TEAR WHILE IN-VIVO WOULD CAUSE A FLUID LEAK FROM THE DEVICE AND THE PT WOULD HAVE DIFFICULTY INFLATING THE DEVICE. ADDITIONALLY, FOUR SEPARATION/LEAKAGE SITES, IF EXISTING WHILE IN-VIVO, ALSO WOULD CAUSE DIFFICULTY INFLATING THE DEVICE. THE PUMP DOES NO HAVE AN APPARENT LEAKAGE SITE. DUE TO THE FUNCTION OF THE PUMP'S OUTLET VALVES, THE PT MAY HAVE EXPERIENCED AUTOINFLATION OF THE DEVICE. HOWEVER, SINCE THE RECEIVED INFO APPARENTLY DOES NOT INDICATE A VALVE MALFUNCTION OR AUTOINFLATION, QA CONCLUDES THAT AUTOINFLATION IS MOST LIKELY NOT THE CAUSE FOR THE EXPLANT SURGERY.
BLOOD WAS NOTICED IN TUBING, BALLOON WAS REMOVED AND REPLACED, PT IS DOING WELL.
INVESTIGATION CONDUCTED. DR CITES PRE-EXPOSURE LOADING OF THE IMPLANT, INSUFFICIENT BONE QUANTITY & QUALITY AS WELL AS THE PT'S SYSTEMIC SMOKING AS CAUSES FOR FAILURE. THIS FILE IS CLOSED.
MAMMOGRAM INDICATED POSSIBLE IMPLANT RUPTURE. REMOVED IMPLANT 10/9/96 WHICH WAS FOUND TO BE RUPTURED. BREAST CAPSULE AND IMPLANT SENT TO PATHOLOGY. FIBROUS CAPSULAR SEGMENTS WITH ENTRAPPED FOREIGN BODY MATERIAL CONSISTENT WITH ORIGIN FROM MAMMARY PROSTHESIS AND ASSOCIATED FOREIGN BODY GRANULOMATOUS INFLAMMATORY REACTION (RIGHT MAMMARY CAPSULE) PER PATHOLOGY REPORT.
ON THE 7TH INFLATION, THE BALLOON BURST AT 14-15 ATMOSPHERES.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. REPORT RECEIVED FROM THE FIELD INDICATED THAT, DURING CLINICAL USE, THE BALLOON BURST ON THE 7TH INFLATION AT AN INFLATION PRESSURE OF 14-15 ATMOSPHERES. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: THE BALLOON EXHIBITED A 0.9 CM LONG, AXIALLY-DIRECTED TEAR, 1.1 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAMINATION: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING THE TEAR EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON TEAR COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/17/96 - METWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
I/A TUBING LEAKING AT THE LUER-LOCK. SURGERY WAS NOT DELAYED AS ANOTHER PACK WAS USED TO COMPLETE. NO EFFECT ON PT.
EVAL SUMMARY FROM H3 ABOVE: THE LEAK IN THE TUBING IS ATTRIBUTED TO A CONNECTOR. DEVICE WILL BE RETURNED TO VENDOR FOR EVAL.
DR INHERITED PT, THIS IS THE SECOND TIME ABUTMENT FAILED IN THREE YEARS. ABUTMENT BROKE BEFORE (NO OTHER INFO KNOWN). THIS TIME ABUTMENT WAS LOOSE AND DR ELECTED TO CUT IT OFF. PT IS REPORTEDLY FINE.
WHILE TRANSFERRING THIS RESIDENT FROM HIS CHAIR TO THE SHOWER STRETCHER BY PT LIFT HE WAS EXPERIENCING SEVERE TREMORS. HE TURNED UNEXPECTEDLY AND THE S HOOK ON THE LIFT PUNCTURED HIS R AXILLA. RESIDENT WAS ADMITTED TO HOSP 10/16/96 - DX PUNCTURE WOUND R AXILLA - TREATMENT 5 SUTURES.
BALLOON LEAK NOTED AFTER 12 HOURS OF USE . THE IAB WAS REMOVED AND REPLACED.
H-11-ALL UNK INFO REQUESTED BUT NOT REC . H-11 SECTION F PROVIDED BY MANUFACT H-11 DEVICE CODE 1746 LABEL H-10 SECTION F INFO REPORTED BY USER FACILITY AND DISTRIBUTOR.
DR REPORTED THAT TWO ABUTMENTS BROKE IN FUNCTION.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS COMPLETED AND FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
WHEN PREPARING FOR SURGERY, CUSTOMER NOTICED THAT THERE WAS NO "TUBING" (CASSETTE INSERT) BETWEEN THE CHAMBERS. SURGERY WAS NOT DELAYED AS ANOTHER PACK WAS USED TO COMPLETE. NO EFFECT ON PT.
EVAL SUMMARY FROM H3 ABOVE. THE CASSETTE INSERT WAS MISSING ON THE RETURNED CASSETTE.
GUIDING CATHETER CAME APART IN THE MIDDLE OF SHAFT.
DURING CLINICAL USE, WITHIN A NON TORTUOUS AND SLIGHTLY DILATED AORTIC ROOT, THE CATHETER WAS UTILIZED TO OBTAIN PRESSURES. FOLLOWING PRESSURE MEASUREMENTS, THE CATHETER DID NOT APPEAR TO BE TORQUING CORRECTLY AND, ON FLUORO, WAS FOUND TO BE FRACTURED 32 CM FROM THE HUB; A THREAD OF CATHETER MATERIAL HELD THE PIECES TOGETHER. A GUIDE WIRE WAS INSERTED AND USED TO WITHDRAW THE ENTIRE CATHETER. UPON WITHDRAWAL, THE CATHETER WAS CUT TO FACILITATE REMOVAL. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAM: THE CATHETER WAS RECEIVED IN TWO PARTS; THE HUB PORTION WAS 31 CM LONG; AND THE DISTAL PORTION 68 CM LONG. THE DISTAL END OF THE HUB PORTION EXHIBITED A TWISTED FRACTURE SURFACE AND THE EXTERNAL MATERIAL EXHIBITED SEVERAL TEARS. ALSO, THE DISTAL PORTION DEMONSTRATED EVIDENCE OF HAVING BEEN CUT WITH A SHARP EDGE TOOL. DIMENSIONAL EXAM: THE INNER AND OUTER DIAMETERS OF THE CATHETER WERE FOUND TO BE WITHIN DIMENSIONAL SPECIFICATIONS. MICROSCOPIC EXAM: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) OF THE BRAID WIRE FRACTURE SURFACES REVEALED EVIDENCE OF DUCTILE AND TORSIONAL FRACTURE MODES. ALSO, THE TORN AND ELONGATED BODY MATERIAL EXHIBITED A CIRCULAR MOTION. THERE WAS NO EVIDENCE OF MATERIAL DEGRADATION OF THE EXTERNAL SURFACE OF THE CATHETER. IT IS POSSIBLE THAT THE CATHETER MAY HAVE BEEN SUBJECTED TO TORSIONAL OVERLOADING BEYOND ITS DESIGN CAPABILITIES.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED, SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR'S OFFICE.
THE BALLOON RUPTURED FOLLOWING 2ND DILATATION OF THE STENT.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. REPORT RECEIVED FROM THE FIELD INDICATED THAT, THE BALLOON RUPTURED FOLLOWING 2ND DILATATION OF THE STENT. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. REPORTEDLY, THE PRODUCT WILL NOT BE RETURNED FOR EVAL AND TESTING. THIS FILE IS CONSIDERED CLOSED. SHOULD THE PRODUCT BE RETURNED AT A LATER DATE, A FOLLOW UP WILL BE SUBMITTED FOR REVIEW.
THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. ON THE SECOND FIRING, THE CARTRIDGE DID NOT FIT THE INSTRUMENT AND FELL INTO THE PT (COULD RECOVER FROM THE PT.) AFTER THAT THE DR. FIRED TWICE WITH THE SAME INSTRUMENT AND FELT HARD FEEDBACK TO FIRE. THE INSTRUMENT COULD NOT ROTATE. THERE WAS NO CONSEQUENCE TO THE PT.
EVALUATION SUMMARY INADVERTENTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "DROPPED THE CARTRIDGE" DURING SURGERY. THE INSTRUMENT WAS RETURNED WITH A NICKED KNIFE, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. NO CONCLUSION COULD BE REACHED AS TO HOW THE KNIFE HAD BECOME DAMAGED. THE CARTRIDGE RETENTION FEATURE WAS MEASURED AND WAS FOUND TO BE CONFORMING. THE INSTRUMENT WAS CYCLED, FIRED, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION BUT HAD A ROUGH CUT DUE TO THE NICKED KNIFE. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE ID. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
PER THE INFO PROVIDED TO CO THROUGH INTERNATIONAL REP, THE DEVICE WAS REMOVED DUE TO "INFECTION AND SEVERE PENILE PAIN IN THE GLANS PENIS". THE PHYSICIAN ALSO NOTED, ...WERE THERE ANY APPARENT CIRCUMSTANCES NOTED THAT MAY HAVE CONTRIBUTED TO THIS OCCURRENCE? "SEVERE FIBROSIS, SO HE NEED MORE MANIPULATION", WAS ANY DIFFICULTY EXPERIENCED DURING IMPLANTATION? ..."YES, SEVERE CORPORAL FIBROSIS"; DID THE PT REPORT DIFFICULTY WITH DEVICE USE? ..."YES, ONLY AFTER APPEARANCE OF MANIFESTATION OF INFECTION".
EVAL OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF PAIN, INFECTION AND FIBROSIS AS REPORTED. THEREFORE, QA WILL ACCEPT THE PHYSICIAN'S DIAGNOSIS OF THESE AS CONTRIBUTING FACTORS TO THIS EVENT. BASED ON THE PROCEDURES BY WHICH THIS DEVICE IS STERILIZED AND RELEASED, QA CONCLUDED THE DEVICE WAS STERILE AND THAT THE INFECTION FROM A SOURCE OR SOURCES OTHER THAN THIS DEVICE. IN ADDITION, BASED ON THE INFO RECEIVED, DEVICE FUNCTION WAS NOT AN ISSUE WITH THIS EVENT.
9/17/96 - METWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL. REPORT. THE CLIP APPLIER WAS RECEIVED FULLY FIRED. THEREFORE, A FULL FUNCTIONAL EVALUATION COULD NOT BE PERFORMED.
FINAL ANALYSIS REVEALED THE DRIVE NUT BINDS DUE TO RUST AND CORROSION BUILD-UP PREVENTING PROPER FUNCTION. THIS ANOMALY COULD RESULT IN INACCURATE DELIVERY. S/N PRE-DATES DRIVE NUT MATERIAL CHANGE.
USER SUSPECTED PIN HOLES IN CIRCUIT DURING PRE-ANESTHESIA SETUP TESTING (AS INSTRUCTED BY PRODUCT'S POLYBAG LABELING). THERE WAS NO PT INVOLVEMENT. EVAL SUMMARY: LEAK TESTS WERE PERFORMED ON THREE RETURNED BREATHING CIRCUITS. CIRCUITS, IDENTIFIED AS LOT #234G, WERE FOUND TO LEAK IN EXCESS OF CO'S ESTABLISHED CRITERIA. VISUAL EXAMINATION OF THESE CIRCUITS FOUND DEFECT CHARACTERISTICS SIMILAR TO ONE ANOTHER BUT NOT TO THE THIRD RETURNED CIRCUIT'S HOSES. CO HAS BEEN UNABLE TO DETERMINE THE EXACT CAUSE OF THIS DAMAGE AND CONSIDER THIS TO BE AN UNUSAL OCCURRENCE. ALTHOUGH THE THIRD CIRCUIT DID NOT LEAK, CO DETERMINED THAT IT WAS FROM THE SAME VINTAGE OF CORRUGATED HOSE THAT COULD POSSIBLY CAUSE A CIRCUIT TO LEAK IN EXCESS OF ITS CRITERIA. CO IS THEREFORE, ALSO INCLUDING ITS LOT CONTROL NUMBER INFO (229G) ON THIS SUBMITTED REPORT. THE ABOVE MENTIONED DEFECT IS NOT CONSIDERED TO REPRESENT A SIGNIFICANT HEALTH HAZARD BUT COULD CAUSE A MINOR DELAY IN INITIATING AN ANESTHETIC PROCEDURE. CO HAS ALSO INITIATED A RECALL AFFECTING A LIMITED VINTAGE OF ADULT BREATHING CIRCUITS IDENTIFIED AS CONTAINING THE SAME LOT CONTROL NUMBER OF THE SUSPECT CORRUGATED HOSE IN QUESTION (229G). CO ALSO DETERMINED THAT LOT #234G IS NOT PART OF THIS PRODUCT RECALL.
THE TIBIAL INSERT WOULD NOT SEAT IN THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: DOWNWARD PRESSURE WAS APPLIED TO THE INSERT BEFORE IT WAS CORRECTLY ENGAGED WITH THE POSTERIOR FLANGES OF THE BASEPLATE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. "WHEN DR. OPENED THE NEW PACKAGE, HE FOUND THE CLIPS WERE MALFORMED, THEN THEY DROPPED FROM JAW." THERE WAS NO CONSEQUENCE TO THE PT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. "WHEN DR. OPENED THE NEW PACKAGE THE CLIPS WERE MALFORMED, THEN THEY DROPPED FROM JAW." THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: YIELDED JAWS. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
PARAMEDICS WERE ATTENDING TO A PT IN FULL CARDIAC ARREST, EXHIBITING A SLOW IDIOVENTRICULAR RHYTHM. ALLEGEDLY THE UNIT LOCKED UP AND WOULD NOT RECORD, PACE OR CHARGE HOWEVER THE OPERATOR WAS ABLE TO MONITOR THE PT SUCCESSFULLY. A BACK UP DEVICE WAS OBTAINED AND USED TO TREAT THE PT. THE PT WAS NOT RESUSCITATED. THE REPORTER STATED ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PT. THIS OPINION WAS BASED ON THE OPERATOR'S ASSESSMENT OF THE PT'S VIABILITY AND THE AVAILABILITY OF A BACK UP UNIT.
PHYSIO-CONTROL EXAMINED THE DEVICE AND OBSERVED THE CHART RECORDER GEARS TO SLIP SLIGHTLY, ALTHOUGH CONTINUING TO FUNCTION. NO OTHER MALFUNCTIONS WERE OBSERVED. THE UNIT WILL BE REPLACED TO ENHANCE CUSTOMER CONFIDENCE AND WILL NOT BE RETURNED TO THE CUSTOMER FOR USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
ON 9/26/96, PT NOTICED PERITONEAL DIALYSIS FLUID LEAKING THROUGH CATHETER TRACK AND AT THE SAME TIME THE CATHETER APPEARED TO BE ABOUT 6 INCHES OUTSIDE ITS NORMAL LOCATION. PT PUSHED CATHETER BACK IN ABDOMEN AND WITH IN HOURS, SYMPTOMS OF PERITONITIS DEVELOPED. PT WENT TO THE ER AND CATHETER WAS REMOVED BY SIMPLY PULLING IT OUT. THE DEVICE APPEARED TO HAVE THE DACRON CUFFS DETACHED FROM THE CATHETER. DESPITE ANTIBIOTIC THERAPY, PT DEVELOPED PERITONITIS. PT WAS PLACED ON HEMODIALYSIS AND DID NOT TOLERATE IT WELL RESULTING IN SHOCK SYMPTOMS, RESPIRATORY FAILURE, AND CARDIAC FAILURE. ON 9/29/96, A NEW PERITONEAL DIALYSIS CATHETER WAS IMPLANTED. PT WAS IN ICU FOR THREE WEEKS, AND IS NOW SLOWLY RECOVERING.
IS THE FREQUENCY OF THE OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. THEN IS THE FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? UNK. IS THE SEVERITY OF THE OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING" NO. THEN IS THE SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? UNK.
WHEELCHAIR BOUND RESIDENT WITH CONTRACTURES OF FEET 2ND DEGREE RHEUMATOID ARTHRITIS WAS NOT A CANDIDATE FOR WHEELCHAIR RESTS, FEET DID NOT REACH FOOTRESTS. THIS RESIDENT WAS TURNING AWAY FROM DINING ROOM TABLE WHEN HER (L) GREAT TOE GOT CAUGHT IN THE (L) FRONT (SMALL) WHEEL RESULTING IN A (1CM X 3CM) LACERATION TO THE TOE THAT REQUIRED STITCHES.
THE END PIECE OF THE SLIDE HAMMER SHAFT BROKE OFF. THERE WAS NO ADVERSE CONSEQUENCE OR SURGICAL DELAY.
SUMMARY OF EVALUATION: EVALUATION REVEALED THE DESIGN COUPLED WITH USER ERROR, SPECIFICALLY APPLICATION OF BENDING MOVEMENT ON SHAFT/COLLAR CONTRIBUTED TO FAILURE.
THE PERSON REPORTED MOUTH AND TRACHEAL IRRITATION AFTER BEING RELEASED FROM THE HOSP.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PTODUCT? N. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IF "NO", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? N. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
ON PIECE OF PARTICULATE ENTERED THE PT'S EYE WHILE USING THIS HANDPIECE.
SECTIONS A-F WERE COMPLETED BY MFR. CUSTOMER COMPLAINT COULD NOT BE DUPLICATED.
DURING SVC OF PRODUCT A MOTOR STALL, WITH AUDIBLE LOW PRESSURE ALARM, WAS FOUND DUE TO TRANSISTOR Q10 OR THE MOTOR BOARD BEING OUT OF SPEC. REPLACED Q10.
DR REPORTED THAT A SCREW BECAME LOOSE. DR TOOK ABUTMENT AND CROWN OFF-IT WAS DAMAGED. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO WAS ABLE TO REVIEW THE PRODUCT'S LOT HISTORY AND IT WAS FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
PARTICULATE WAS SEEN COMING FROM THIS PHACOEMUSLIFICATION HANDPIECE DURING A CATARACT EXTRACTION PROCEDURE ON 9/25/96. THERE HAVE BEEN MANY OTHER CASES OF PARTICULATE DURING PHACO SURGERIES, TOO MANY TO REMEMBER. NO HANDPIECES WILL BE RETURNED FOR EVAL.
THESE FOUR HANDPIECES WERE RETURNED FOR EVALUATION AGAINST THIS COMPLAINT. ONE OF THE HANDPIECES MAY HAVE BEEN INVOLVED IN THE REPORTED INCIDENT OF PARTICULATE. ALL HANDPIECES WERE MFG IN MAY OF 1996. ALL HANDPIECES PASSED THE ELECTRICAL, MECHANICAL AND PERFORMANCE TESTS. A TOTAL OF THREE FILTER TESTS WERE PERFORMED ON EACH OF THE HANDPIECES. TWO TESTS WERE RUN ON 3/6/97 AND ONE TEST WAS RUN ON 3/10/97. A HIGH PERCENTAGE OF THE PARTICLES RANGED IN COLOR FROM ORANGE TO BLACK. ALL PARTICLES APPEARED TO BE NON-METALLIC.
THE ENDOBRONCHIAL TUBE WAS NOT IN THE BOX WHEN THE BOX WAS FIRST OPENED.
NO EVAL CODE 81: THE ORIGINAL BOX WAS RETURNED TO THE REPORTING SITE. IT CONTAINED THE USUAL COMPONENTS THAT WOULD BE PRESENT WITH AN ENDOBRONCHIAL TUBE. SINCE THIS REPORT IS NOT RELATED TO THE DEVICE, BUT RATHER TO THE REPORT THAT THE DEVICE WAS MISSING, NO DEVICE EVAL WAS PERFORMED. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? N. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IF "NO", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? N. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
DURING SVC OF PRODUCT DEVICE WAS FOUND TO NOT CYCLE, WITH ALL LEDS AND A CONSTANT SINGLE TONE AUDIBLE ALARM, DUE TO CAPACITOR C6 MISSING FROM MOTOR BOARD. DEVICE RETURNED TO COMPAIRED AT CUSTOMERS REQUEST MANUFACTURER INFORMED CUSTOMER THAT IT DOES NOT RECOMMEND DEVICE FOR PT USE UNTIL PROPER REPAIRS HAVE BEEN PERFORMED BY AUTHORIZED PERSONNEL. MFR DISABLED DEVICE PRIOR TO RETURNING IT TO CUSTOMER.
H6 100-FAILURE MODECAUSED BY MISSING COMPONENT. H6. 68-DEVICE RETURNED UNREPAIRED AT CUSTOMERS' REQUEST. LABELING 1738.
BED WAS NOTED TO BE DEFLATED WITH PT SUNK (DEPRESSED) INTO THE MATTRESS. THERE HAD BEEN A SMELL OF SOMETHING BURNING BY A THERAPIST. MFR STATED IT MUST BE AN ELECTRICAL MALFUNCTION. THE PT HAD A PINK AREA NOTED ON HER LEFT NECK OF ABOUT 3 CM BY 1 CM WHICH HAS CHANGED TO A MUCH DARKER AREA. PLASTIC SURGEON WAS CALLED FOR CONSULT; HE DIAGNOSED AS A CONTACT BURN. THE BED HAD BEEN IN USE ABOUT 24 HRS. THERE IS A QUESTION IF THERE MAY BE SOME DAMAGE AFTER AN X-RAY WAS TAKEN. ? CAUSE OF DEFLATION AT THIS TIME. THERE WAS OTHER EQUIPMENT IN USE AT THE TIME OF THE EVENT. ALL THE EQUIPMENT HAD SAFETY CHECKS VERY RECENTLY. MFR IS VERY CONFUSED AS TO WHAT EXACTLY MAY HAVE CAUSED THIS EVENT. THE FACT IS THE BURN AREA ON THE LEFT LATERAL NECK INDICATES THAT THE PT WOULD HAVE HAD A BURN PERHAPS ON HER BACK AS THAT WAS THE MOST DEPENDENT AREA IN THE BED. RPTR HAS ATTEMPTED TO DETERMINE IF SOME OTHER FACTOR WOULD HAVE CONTRIBUTED. THERE HAS BEEN A SUGGESTION THAT A BLANKET UNDER THE PT MAY HAVE HAD A WET AREA ABOUT THE NECK WHICH WOULD THEN HAVE CONTRIBUTED. AT PRESENT, THE FACILITY CAN'T CONFIRM THIS SUGGESTION.
THIS PHACOEMULSIFICATION HANDPIECE WOULD NOT IRRIGATE DURING A CATARACT EXTRACTION PROCEDURE, ANOTHER HANDPIECE WAS USED.
THE CUSTOMERS COMPLAINT COULD NOT BE DUPLICATED. RESULTS OF VISUAL EVAL FOUND THE IRRIGATION TUBE BENT AND TWISTED, THE ASPIRATION TUBE CLOGGED.
LAB TECH REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
NURSE WAS CLEANING A STERILIZER. SHE MOVED THE CONTAINER THAT THE SOLUTION WAS IN AND SOME OF THE PRODUCT SPLASHED INTO HER EYE. NURSE RINSED THE EYE WITH SOLUTION AT THE EYEWASH STATION FOR ABOUT 15 MINUTES.
NURSE RECEIVED MEDICAL INTERVENTION FROM THE DR. THE DR TOOK A LOOK AT NURSE'S EYE AND SAID IT APPEARED TO BE FINE. HE ALSO PUT A FEW DROPS OF SOME TYPE OF EYEDROPS. SHE WAS NOT ABLE TO INDICATE WHAT KIND.
DURING SVC OF PRODUCT A NO APEA ALARM CONDITION WAS FOUND DUE TO TRANSFORMER T1 ON THE ANALOG BOARD BEING OUT OF SPEC. REPLACED T1.
THE TRACHEAL CUFF DOES NOT STAY INFLATED.
CODE 200: LEAK IN CUFF COULD HAVE BEEN CAUSED BY SCORING THE SURFACE OF THE CUFF THROUGH CONTACT WITH THE PT'S TEETH OR OTHER SHARP OBJECT, DURING OR PRIOR TO INTUBATION. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO", IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? N. IS EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IF "NO", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? N. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
PARTICULATE WAS SEEN FROM THIS PHACOEMULSIFICATION NEEDLE DURING A CATARACT EXTRACTION PROCEDURE.
DR REPORTED THAT TWO SINGLE CROWNS IN SAME PT CAME LOOSE. THEY WERE BROKEN AT THE WELD. PT IS REPORTEDLY FINE.
EVALUATION: PART WAS LOST IN TRANSIT. ENVELOPE WAS RECEIVED WITH A LARGE HOLE IN IT.
9/26/96 1600 HR DR CONFIRMED THE INFO AS REPORTED BY THE SALES REP. THE CLIPS WERE SCISSORING ON EACH FIRING FROM THE BEGINNING OF THE CASE. APPROX 4-6 ATTEMPTS WERE MADE TO USE THE INSTRUMENT, BUT EACH TIME THE CLIPS WERE SCISSORING TO SOME DEGREE. THERE WAS SOME CONTUSION TO THE STRUCTURE, BUT NO SIGNIFICANT DAMAGE OCCURRED. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. TSB
REPORT OF ALLEGED "ALARM WONT ADJUST, TOO LOW. NOT IN PT USE".
H6. 100 LOW VOLUME AUDIBLE ALARM DUE TO FOREIGN SUBSTANCE OR ALARM COMPONENT. 68 LOW VOLUME AUDIBLE ALARM DUE TO FOREIGN SUBSTANCE OR ALARM COMPONENT. REMOVED FOREIGN SUBSTANCE OR ALARM COMPONENT. TESTING BY MFR FOUND ALOW VOLUME AUDIBLE ALARM DUE FOREIGN SUBSTANCE ON ALARM COMPONENT. REMOVED FOREIGN SUBSTANCE.
DR'S OFFICE REPORTS "DULL/ROUGH EDGES ON SEVERAL KNIVES; INCISIONS ARE REQUIRING SUTURES".
NO ADD'L INFO HAS BEEN RECEIVED FROM REPORTER DESPITE REQUEST. DECISION TO FILE THIS REPORT WAS BASED ON INFO RECEIVED FROM SUBSEQUENT REPORTS, WHICH HAVE BEEN FILED, WHERE THE REPORTER STATED THE POSSIBILITY EXISTS FOR SERIOUS INJURY WITH THIS INCIDENT. NO VISUAL DEFECTS WERE FOUND IN A RETURNED UNOPENED SAMPLE FROM THE SAME LOT. THE BLADE ALSO PASSED PENETRATION FORCE SPECS. A VIDEO OF SURGICAL PROC. SHOWED THAT THE DR INSERTED THE BLADE BEYOND ITS WIDEST POINT ("EARS") AND TRIED TO CUT AS HE WITHDREW. THIS BLADE DOES NOT HAVE A CUTTING EDGE BEYOND THE EAR. INFO FOR SECTION F 1. NA, 2. NA, 3. AS IN E.1, 4. AS IN E. 1, 5. AS IN E.1,6. UNK, 7. UNK, 8. 9/4/96, 9. 3 MOS, 10. UNK, 11. UNK, 12. UNK, 13. YES, 9/4/96, 14. AS IN G.1. THIS REPORT WAS MAILED IN TO FDA ON: 10/29/96. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
DURING SVC OF DEVICE PRODUCT WAS FOUND TO NOT CYCLE WITH ALL LEDS AND CONSTANT SINGLE TONE ALARM, DUE TO INTEGRATED CIRCUIT V10 ON LOGIC   BOARD BEING OUT OF SPEC.
DURING TRANSFER FROM SHOWER STALL TO DRESSING AREA, SHOWER CHAIR HAD TO BE LIFTED UP OVER BOARD ON FLOOR IN FRONT OF SHOWER STALL. IN THE PROCESS, THE FRONT 3 POSITION T AT SIDE (SITTING IN CHAIR) BROKE IN MULTIPLE SECTIONS AND SIDE OUTER RAIL BOTTOM CAME APART FROM 3 POSITION T. RESIDENT FELL OUT ON FLOOR IN SHOWER ROOM, RECEIVING 4-5 CM KNOT ON LT SIDE FOREHEAD WITH RAISED AREA INSIDE KNOT; SMALL CUT, ABRASION ON OUTSIDE AT ELBOW, SHOULDER, AND LT SIDE BACK. ALL WITH MULT ABRASION AND ALL RED.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED THE STAPLES WOULD NOT FORM PROPERLY OR WOULD JAM. THERE WAS NO CONSEQUENCE TO THE PT. 9/25/96 REP REPORTS AN EMS WAS USED TO COMPLETE THE PROCEDURE.
RESULTS OF EVALUATION: CONCLUSION: ABC)BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATIONS AND THE FUNCTIONAL TESTS, IT WAS CONCLUDED THAT THE INSTRUMENTS WERE CONFORMING WITH REGARD TO STAPLES FEEDING, FIRING AND FORMING. ABC)THE INSTRUMENTS WERE RECEIVED IN GOOD PHYSICAL CONDITION AND WERE EXAMINED AND FOUND TO BE FUNCTIONAL. A)THE INSTRUMENT WAS CYCLED AND FIRED THE REMAINING STAPLE WITHOUT INCIDENT. B)THE INSTRUMENT WAS CYCLED AND FIRED THE REMAINING 12 STAPLES WITHOUT INCIDENT. C)THE INSTRUMENT WAS CYCLED AND FIRED THE REMAINING 2 STAPLES WITHOUT INCIDENT. ABC)NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT'S "WOULD NOT FORM PROPERLY OR WOULD JAM" DURING SURGERY. COMMENTS: ABC)EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. THE INSTRUMENT'S STAPLES MAY MALFORM OR REFECT IF FIRED INTO A HARD OBJECT, SUCH AS BONE. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
PARTICULATE WAS SEEN FROM THIE PHACOEMULSIFICATION NEEDLE DURING A CATARACT EXTRACTION PROCEDURE.
DURING SVC OF PRODUCT A CONTINUOUS CYCLE NO VOLUME DELIVERED WITH AUDIBLE AND VISUAL ALARMS, WAS FOUND DUE TO MAGNETIC SENSOR BEING OUT OF SPEC. REPLACED MAGNETIC SENSOR.
THE PUMP WAS IN USE ON A PT WHEN IT STOPPED. THE PT WAS SWITCHED TO ANOTHER PUMP WITH NO COMPLICATIONS. THE HOSP'S BIOMEDICAL DEPT TRIED TO FIX THE PUMP, BUT WAS NOT SUCCESSFUL. THE HOSP DOESN'T HAVE A SERVICE CONTRACT WITH CO. HOWEVER, THEY DID CALL CO AND SERVICE WAS PROVIDED.
INCIDENT WAS EVALUATED BY THE CO FIELD SERVICE REP. HE REPLACED THE 5V/36V AND PS BOARD. ALSO, HE FOUND THE CONDENSATE BOTTLE FULL OF WATER, AND BACTERIA AND MOLD GROWTH IN THE CONDENSATE TUBING AND SOLENOID. THE SOLENOID WAS CLEANED AND A LOOSE GROUND NUT TIGHTENED. THE PUMP WAS CHECKED FOR FUNCTION AND RAN NORMALLY.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE EXHIBITED REDUCED ASPIRATION. ANOTHER HANDPIECED WAS USED TO COMPLETED THE PROCEDURE.
NO REPORT OF MALFUNCTION OR SERIOUS INJURY OR REASON FOR EXPLANT PROVIDED. LEAD HAS BEEN RETURNED. FAILURE ANALYSIS IS PROVIDED.
DURING SVC OF PRODUCTS POTENTIAL NO LOW PRESSURE ALARM CONDITION WAS FOUND DUE TO TRANSDUCER BEING OUT OF CALIBRATION. RECALIBRATED TRANSDUCER.
THE PUMP WAS SET TO DELIVER 1200 UNITS OF HEPARIN AND 12,000 WAS NOTED TO HAVE INFUSED IN 1 HR. THERE WAS NO PT COMPLICATION.
THE PUMP WAS RETURNED FOR EVAL. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND THE PUMP WAS FOUND TO MEET ALL MFR'S SPECIFICATIONS. THERE WAS NO VISUAL DAMAGE NOTED. THE ACCURACY WAS TESTED AT SEVERAL RATES AND PASSED ALL TESTS. IT IS SUSPECTED THAT A POSSIBLE MISLOAD OF THE IV SET MAY HAVE CAUSED THE REPORTED OVERINFUSION. ADD'L INSERVICING WILL BE RECOMMENDED ON PROPER LOADING OF THE IV SET PER THE DIRECTIONS FOR USE, PAGE 9, WHICH STATES, "CLOSE THE MECHANISM BY PUSHING THE ORANGE LATCH TO THE LEFT. VERIFY THE TUBING IS FULLY WITHIN THE MECHANISM AND THE AIR-IN-LINE DETECTOR...DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH.". THIS REPORT WAS FILLED OUT BY THE MFR. PT INFO WAS NOT AVAILABLE FROM THE USER FACILITY FOR INFO IN SECTIONS A-1,2,4 AND B-6,7 AND F-10 WAS NOT AVAILABLE FROM THE USER FACILITY. MFR'S REPORT DATE 10/25/96.
THE GUIDE WIRE BRAKE WOULD NOT HOLD ONTO THE GUIDE WIRE. THE ADVANCER BURR AND GUIDE WIRE TRAVELLED DISTALLY IN THE RCA. THE VESSEL WAS DISSECTED AND TREATED WITH TWO STENTS.
THE BRAKE INTERMITTENTLY STICKS DUE TO DRIED SALINE IN THE BRAKE ASSEMBLY. SALINE IS USED IN THE NORMAL OPERATION OF THE DEVICE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
PT HAS PENILE PROSTHETIC DEVICE DUE TO VASCULOGENIC IMPOTENCE. HE UNDERWENT REVISION OF DEVICE 4-6 MONTHS AGO. THIS DEVICE BECAME INFECTED AS MANIFESTED WITH PAIN REQUIRING SURGICAL REMOVAL. PT IS DIABETIC SO ANOTHER DEVICE NOT IMPLANTED.
DURING A CATARACT EXTRACTION PROCEDURE, WHEN THIS PHACOEMULSIFICATION HANDPIECE WAS USED, IT WOULD SHORT OUT THE PHACOEMULSIFICATION UNIT BEING USED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A-F WERE COMPLETED BY MFR. THE HANDPIECE DID NOT SHORT OUT THE UNIT; THE CONDITION OF THE HANDPIECE ALLOWS THE POSSIBILITY OF CAUSING THE UNIT TO RESET.
CLAMP HOLDING TRAPEZE ON FRAME ON THE BED BROKE AND THE TRAPEZE FELL AND HIT PT ON THE HEAD. NO WITNESSES OTHER THAN THE PT.
THE DEVICE WAS USED IN A LAPAROSCOPIC APPENDENTOMY. THE EZ35B BROKE ON TISSUE AND WOULD NOT READILY RELEASE. THE SURGEON MANAGED TO REMOVE THE DEVICE EVENTUALLY. THERE WAS NO CONSEQUENCE TO THE PT.
EVALUATION SUMMARY INADVERTANTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
AN OVER INFUSION OCCURRED. PUMP WAS SET TO DELIVER 500 MLS AT A RATE OF 20 ML/HR. THE BAG WAS EMPTY IN APPROX ONE AND A HALF HRS.
MFR RPT DATE 8/22/97. ONLY THE LATCH MECHANISM OF THE PUMP WAS RETURNED. IT WAS DETERMINED THAT THE LATCH WAS BROKEN. THE FACILITY STATED THAT THE PUMP HAD BEEN DROPPED AND NOT CHECKED BY BIOMED. THE UNDERSIDE OF THE COMPONENT SHOWED RESIDUE FROM CHEMICAL ATTACH RESULTING IN A BRITTLE FRACTURE OF THE GLASS FILL POLYCARBONATE AND/OR IMPACT FROM THE PUMP BEING DROPPED. IT WAS ALSO RPT'D THAT THE LATCH HAD NOT BEEN MANUALLY CLOSED-THE DOOR WAS USED TO CLOSE THE LATCH. THE CORRECT SET LOADING PROCEDURE SHOULD BE FOLLOWED PER THE DIRECTIONS FOR USE (PAGE 9) WHICH STATES "CLOSE THE MECHANISM BY PUSHING THE ORANGE LATCH TO THE LEFT. VERIFY THAT THE TUBING IS FULLY WITHIN THE MECHANISM AND THE AIR IN LINE DETECTOR. DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH." THE MFR HAS IMPLEMENTED A LABEL INSTRUCTING THE USER ON THE PROPER LOADING OF THE IV SET WITH A WARNING THAT MISLOADING THE SET MAY RESULT IN A FREEFLOW CONDITION. AS A RESULT OF INSTRUMENT WEAR OR IMPROPER MAINTENANCE, THE MECHANISM GAP MAY NARROW. IF THIS SHOULD OCCUR, IT MAY BE DIFFICULT TO CORRECTLY INSTALL THE IV TUBING, WHICH MAY RESULT IN AN OVERINFUSION. A SAFETY ALERT, DATED APRIL 11, 1997, WAS MAILED INSTRUCTING THE USER TO: A) MEASURE THE MECHANISM GAP. B) REPLACE THE FOLLOWER HOUSING ASSEMBLY IF NECESSARY. C) ENSURE THAT THE SET IS CORRECTLY LOADED INTO THE PUMP MECHANISM. THE MFR REQUESTED PT INFO FROM THE USER. NO PT INFO WAS AVAILABLE.
AS REPORTED IN UF/DIST REPORT #453061-1996-002, HOSP REPORTED IN SECTION D7 THAT THE DEVICE WAS IMPLANTED ON 3/17/96. THIS INFO CONFLICTS WITH THE MFRS RECORDS WHICH REVEALED; INITIAL DATE OF IMPLANT 6/27/89. THE CYLINDER(S) AND PUMP COMPONENT(S) WERE REMOVED AND REPLACED ON 6/27/94. (SEE MENTOR FILE #94-0396, FDA ACCESS #M525284). AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, EVALUATION OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION OR PAIN. THEREFORE, QA ACCEPTS THE PHYSICIAN'S DIAGNOSIS OF THIS AS THE CAUSE FOR REMOVAL. ALL DEVICES SOLD AND LABELLED AS STERILE BY THIS MFR MUST MEET QA AND MFG STERILITY REQUIREMENTS PRIOR TO RELEASE. THEREFORE, QA CONCLUDED THAT THIS DEVICE WAS STERILE UPON RELEASE AND THAT THE INFECTION INITIATED FROM A SOURCE OR SOURCES OTHER THAN THIS DEVICE.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION UNIT WOULD NOT ALLOW APSPIRATION WHEN IN THE PHACO MODE. THE PHACO HANDPIECES WERE EXCHANGED, THE TUBING WAS RECONNECTED, NITROGEN WAS RECONNECTED AND THE SYSTEM WAS REBOOTED. THE UNIT THEN WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE.
SECTIONS: A-F WERE COMPLETED BY THE MFR.
HOSP SUBMITS THIS REPORT PURSUANT TO 21CFR PART 803. THIS REPORT IS BASED ON INFO REVIEWED BY HOSP WHICH HOSP MAY NOT HAVE HAD AN OPPORTUNITY TO INVESTIGATE FULLY OR VERIFY PRIOR TO TH EREPORTING DATE. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY HOSP THAT IT OR ANY OF ITS EMPLOYEES OR AFFILIATES CAUSED OR CONTRIBUTED TO THE INCIDENT DESCRIBED HEREIN. WHILE PERFORMING PHACOEMULSIFICATION ON LEFT EYE THERE SEEMED TO BE POOR ASPIRATION AND FORMATION OF ANTERIOR CHAMBER. A WHITE OPACIFICATION OF THE CORNEA FORMED AND WHITE MATERIAL SEEMED TO EMANATE. PHACOEMULSIFICATION WAS STOPPED, EQUIPMENT CHECKED AND FOUND TO BE SATISFACTORY. ALTHOUGH VISIBILITY WAS LIMITED PROCEDURE WAS COMPLETED. BECAUSE OF CORNEAL BURN IT WAS ELECTED NOT TO DO AN IMPLANT AT THIS TIME AND PT WAS REFERRED TO A CORNEA SPECIALIST FOR FURTHER TREATMENT.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION UNIT EXHIBITED INTERMITTENT AND LOW PHACO POWER.
ASPIRATION FUNCTION OF THIS UNIT WAS FOUND TO BE SLIGHTLY OVER SPEC AND WAS RECALIBRATED.
PT UNDERWENT ENDOMYOCARDIAL BIOPSY. A DISPOSABLE BIOPTOME WAS USED TO OBTAIN MYOCARDIAL BIOPSY SPECIMENS. THE BIOPTOME WAS UNABLE TO RETRACTED. IT PERFORATED THE SUPERIOR VENA CAVA. ATRIAL PACING WIRE EXTRACTION SHEATHS WERE USED TO EXTRACT THE BIOPTOME. THE PT REMAINED HEMODYNAMICALLY STABLE BUT WAS KEPT OVERNIGHT FOR OBSERVATION.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CYSTIC ARTERY WAS BEING LIGATED USING THE ER320. THE SURGEON NOTED THE CLIP GAPPING. THE CLIP WAS REMOVED FROM THE VESSEL AND FROM THE ABDOMEN. THE SURGEON DRY FIRED THE DEVICE ON THE MAYO STAND AND THE CLIP FORMED PROPERLY. THE CASE WAS COMPLETED USING THE SAME APPLIER. THE GAPPING OCCURRED WITH THE FIFTH CLIP. THE DEVICE AND FIFTH CLIP ARE BEING RETURNED FOR ANALYSIS. THERE WAS NO CONSEQUENCE TO THE PT.
EVALUATION SUMMARY INADVERTANTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THERE WERE TWO CLIPS RETURNED IN A SEPARATE BAG. ONE OF THE CLIPS WAS CONFORMING TO DESIGN SPECIFICATIONS. THE SECOND SLIP HAD NON-CONFORMING CLIP GAP. NO CONCLUSION COULD BE REACHED AS TO HOW THE CLIP HAD BECOME DAMAGED. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION UNIT FAILED TO CALIBRATE ONE HANDPIECE AND THERE WAS LOW POWER FROM THE HANDPIECE THAT WAS USED. THE CASE WAS ABLE TO BE FINISHED WITH THE LOWER POER HANDPIEC.
THIS MEDWATCH WAS INITIALLY FILED AGAINST THE UNIT; HOWEVER, THE HANDPIECES WERE THE CAUSE FOR THE REPORTED PROBLEMS. TWO HANDPIECES WERE INVOLVED AND FOLLOWING ARE THE EVALUATIONS FOR EACH HANDPIECE. S/N: METHOD: 23,26,31,38. RESULTS: 120,180. CONCLUSIONS:43. S/N: METHOD: 23. RESULTS: 120. CONCLUSIONS: 43. COMPLAINT WAS ABLE TO BE DUPLICATED.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE DID NOT FIRE CORRECTLY, THE CLIPS SCISSORED. USED ANOTHER INSTRUMENT TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
8/22/96 1350 MESSAGE AND 800 NUMBER LEFT FOR MD TO CALL BACK. 8/22/96 1355 MESSAGE AND 800 NUMBER LEFT ON PHONE MAIL FOR CONTACT PERSON TO CALL BACK. 8/22/96 1405 CONTACT PERSON HAD NO FURTHER INFO SINCE A PROCEDURE DATE WAS NOT KNOWN. 8/22/96 1410 SPOKE WITH RISK MANAGER WHO SAID SHE HAD NO INFO AT THIS TIME, BUT WILL TRY TO INVESTIGATE FOR FURTHER DETAILS. 8/22/96 1420 SURGEON CALLED BACK STATING ON THE FIRST THREE FIRINGS OF THE INSTRUMENT ACROSS THE CYSTIC DUCT THE CLIPS SCISSORED. THE SURGEON REPORTED HE REMOVED THE CLIPS WITHOUT DIFFICULTY AND COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE SURGEON SAID THERE WAS NO CONSEQUENCE TO THE PT. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAM, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECS WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
TEN FR DRAIN TUBE INSERTED DURING SURGERY ON 6/5/96. DURING BEDSIDE REMOVAL OF SAME ON 6/7/96, THE DRAIN TUBE BROKE OFF LEAVING APPROX 6 INCHES IN THE PT'S SUBCUTANEOUS TISSUE (AS CONFIRMED BY X-RAY). PT WAS RETURNED TO SURGERY FOR EXPLORATION AND REMOVAL OF THE RETAINED PORTION OF THE DRAIN TUBE.
THE DISTAL END OF THE SLIDING HAMMER WAS NOT FUNCTIONING PROPERLY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME DUE TO THIS EVENT.
DEVICE NOT MANUFACTURED IN THE US. DEVICE RETURNED DIRECTLY TO MFR. EVAL TO BE PERFORMED AT MFG FACILITY. F 14: HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REC'D FROM A FOREIGN AFFILIATE. AFF'L INFO IS UNOBTAINABLE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC SPLENECTOMY. IT WAS REPORTED BY THE REP. THAT WHEN THE DR. FIRED THE INSTRUMENT, IT BROKE. THERE WAS NO CONSEQUENCE TO THE PT.
D6: DEVICE RETURNED WITH NO LOT IDENTIFICATION.
THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. IT WAS REPORTED BY THE REP. THAT THE CLIP APPLIER DID NOT "FIRE" DURING THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10;H4: INFO NOT PROVIDED. H6: RESULT CODE #400: "YIELDED JAWS". RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION UNIT WOULD NOT ALLOW FOR PHACO CALIBRATION. THE PROCEDURE WAS DELAYED FOR APPROX 1 HR. A MICROVIT CUTTER WAS USED TO REMOVE THE CATARACT SINCE THE CATARACT WAS VERY SOFT.
PT STATED THAT BURNS ON PENIS WAS DUE TO MRI SCAN.
THE DEVICE WAS USED DURING A LAPAROSCOPIC BOWEL RESECTION. IT WAS REPORTED BY THE REP. THE PRODUCT FOUND TO BE FAULTY UPON INITIAL LOADING OF CLIP AND PRIOR TO THE ENTRY INTO THE ABDOMEN. A NEW UNIT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
H6;CODE 400: YIELDED JAWS. A1,2,3,4: B6,7; D10: INFO NOT PROVIDED BY AFFILIATE. D5,6; H4:INFO UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION.
THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. IT WAS REPORTED BY THE REP THAT THE CARTRIDGE DID NOT FIT THE INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D10: INFORMATION NOT PROVIDED BY AFFILIATE. D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
AFTER THE IV WAS SET UP, FLUID WAS DELIVERING FASTER THAN THE SET RATE. NO PT CONSEQUENCE WAS ASSOCIATED WITH THIS EVENT.
THE PUMP WAS VISUALLY AND FUNCTIONALLY TESTED. THE REAR CASE WAS NOTED TO BE DENTED AT THE UPPER LEFT CORNER. THE TOP PLATE WAS MISALIGNED WITH RESPECT TO THE MECHANISM CARRIER. THE TORQUE SEAL ON THE CARRIER SCREWS WAS ALSO BROKEN. THE MECHANISM MOVED BACK FROM THE PRESSURE PLATE WHICH PREVENTED THE TUBING FROM BEING PINCHED OFF COMPLETELY, RESULTING IN FREEFLOW (OVERINFUSION). IT IS SUSPECTED THAT THE PHYSICAL DAMAGE TO THE INSTRUMENT RESULTED FROM IMPACT OF EITHER BEING DROPPED OR HIT. IMPACT DAMAGE CAN CAUSE MISALIGNMENT OF THE MECHANISM. THE UNIT WAS ROUTED THROUGH CO SERVICE DEPT FOR REPAIR AND RETURNED TO THE CUSTOMER. THE CUSTOMER WILL BE INFORMED TO REFER TO SERVICE BULLETIN #298 (JULY 1992) FOR MECHANISM LEAK TEST AND REALIGNMENT PROCEDURE WHEN THE UNIT HAS BEEN DAMAGED. THIS ENTIRE MEDWATCH REPORT WAS COMPLETED BY THE MFR. BLOCK A, B6-7, D10 WERE UNKNOWN BY THE FACILITY.
PT STOOD UP FROM CHAIR AND LEANED ON FOOTBOARD AT WHICH POINT THE FOOTBOARD CAME OFF BOTTOM OF BED CAUSING PT TO FALL TO FLOOR.
LEAD RECEIVED WITH SERIAL ID UNKNOWN. ANALYSIS INDICATES LEAD IS FRACTURED WITHOUT PROTRUSION.
THIS ENTIRE FORM COMPLETED BY MFR. S/N FOR THIS IS UNKNOWN. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE FRACTURED AT WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURS APPROX 87 MM AND HAS MIGRATED DOWN LEAD BODY APPROX 3 MM PROXIMAL OF WELD SITE. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE LEAD WAS SNIPPED OR CUT 36 CMS PROXIMAL OF FIXATION HELIX HOUSING ELECTRODE TIP, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP. THE INSTRUMENT JAMMED IN THE NOSE. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: EXCESSIVE DRIED BODY FLUIDS IN CARTRIDGE AREA. TWISTED STAPLE JAMMED IN THE NOSE OF THE INSTRUMENT. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE AND THE CARTRIDGE NOSE MAY HAVE CAUSED THE REPORTED INCIDENT, IN WHICH THE "STAPLES JAMMED IN THE NOSE" DURING SURGERY. THE INSTRUMENT WAS RECEIVED WITH EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY AND WITH A TWISTED STAPLE JAMMED IN THE NOSE. THE TWISTED STAPLE WAS REMOVED FROM THE CARTRIDGE NOSE AND THE INSTRUMENT WAS CYCLED AND FIRED THE REMAINING 14 STAPLES INTERMITTENTLY. DURING THE CYCLING OF THE INSTRUMENT, 2 OTHER STAPLES WHICH HAD TWISTED DUE TO THE EXCESSIVE DRIED BODY FLUIDS, HAD TO BE REMOVED BEFORE TEST FIRING COULD CONTINUE. IT WAS CONCLUDED THAT THE INTERMITTENT FEEDING OF THE STAPLES DURING TESTING WAS ALSO DUE TO THE EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
SMOKE AND FIRE IN LOWER COMPARTMENT OF WARMING CABINET. CUSTOMER CLAIMS A DESIGN PROBLEM SINCE THEY FOUND ALL OF THE SCREWS FOR THE HEATER ELEMENT WERE LOOSE.
ON-SITE EXAM BY TECH REVEALED HEAT DAMAGE IN CABINET. TECH DISCOVERED THAT THE THERMOFUSE HAD A JUMPER WIRE IN PLACE, DEFEATING THE OVERTEMP PROTECTION. IT WAS ALSO REVEALED TO THE TECH BY AN ELECTRICIAN AT THE ACCOUNT, THAT WHEN HE FIRST EXAMINED THE UNIT THE HEATER ELEMENT WAS NOT ATTACHED TO THE CERAMIC STAND OFF. WHEN TECH INSPECTED UNIT THE ELEMENT HAD BEEN REATTACHED TO THE CERAMIC STAND-OFFS, HOWEVER IT WAS REPORTED THAT THE STAND-OFFS WERE CRACKED. THE CABINET IS MAINTAINED BY A THIRD PARTY SERVICE GROUP, PREVENTIVE MAINTENANCE SERVICES. BASED ON A REVIEW OF THE CABINET (VIDEOTAPE, STILL PHOTOS, AND ON-SITE EVAL BY THE TECH), IT APPEARS THE UNIT WAS MODIFIED BY THE ACCOUNT. APPARENTLY THE THERMOFUSE HAD BEEN REMOVED FROM THE HEATER ASSEMBLY AND "JUMPERED" WITH A SHORT PIECE OF WIRE. THIS COMBINED WITH THE OVERSTUFFING OF THE LOWER COMPARTMENT, ALLOWED HEAT TO BUILD UP IN THE CONTROL AREA, ULTIMATELY RESULTING IN THE SMOLDERING BLANKETS THAT WERE ORIGINALLY REPORTED. THE EVENT OCCURRED DUE TO AN UNAUTHORIZED MODIFICATION BY THE CUSTOMER. CUSTOMER HAS BEEN ADVISED TO NOT CIRCUMVENT SAFETY FEATURES, AND CORRECTIVE ACTION IN THE FORM OF REPAIRING THE CABINET HAS BEEN INITIATED. UNLESS ADD'L INFO ARISES CO PLANS TO TAKE NO FURTHER ACTION AND CONSIDERS THIS CLOSED.
THE PENCIL WAS INVOLVED IN A VERY MINOR BURN OF AN OR NURSE ON 10/09/96. THE CORD WAS DRAPED ACROSS THE MAYO AND WHEN THE NURSE LEANED ON THE MAYO AND WHEN THE NURSE LEANED ON THE MAYO STAND THE CURRENT TOOK AN ALTERNATE PATCH THROUGH HER ARM AND RESULTED IN THE BURN. THERE APPEARS TO BE  PIN HOLE ON THE CORD.
EVAL OF THE DEVICE RETURNED INDICATED THAT THE CABLE AREA MARKED BY TAPE WHERE THE LEAKAGE WAS POSSIBLY LOCATED DID NOT SHOW EVIDENCE OF A CABLE BURN OR INSULATION DAMAGE WITH VISUAL INSP OF UNDER 4X MAGNIFICATION. THERE WAS NO EXTERNAL DAMAGE OBSERVED ON ANY PORTION OF THE CABLE. THE CABLE WAS SUBJECTED TO ASPEN LABS ENGINEERING QUALIFICATION TESTS FOR HIGH FREQUENCY LEAKAGE CURRENT TEST PER AAMI HF18 AND ADDITIONALLY A HIGH VOLTAGE/HIGH FREQUENCY TEST AND DIELECTRIC WITHSTAND TEST FOR CABLES PER ECRI. THE DEVICE WAS VISUALLY EXAMINED PRIOR TO AND FOLLOWING THE TESTING FOR ANY INDICATION OF INSULATION DEFECTS. THE DEVICE PASSED THE THREE TESTS WITH NO INDICATIONS OF ANY INSULATION BREAKDOWN AND THE HF LEAKAGE VALUES PER AAMI WERE CONSISTENT WITH EXPECTED VALUES FOR PREVIOUS PRODUCTS RESULTS. THERE WERE NO BURN MARKS ON THE INCIDENT DEVICE WHEN REC'D NONE AFTER TESTING. THE AREA IN QUESTION WAS INCLUDED AS PORTION OF THE CABLE TESTED IN ALL CASES. THESE TESTS USE A SALINE SOAK OF THE CABLE TO CONDITION THE MATERIAL FOR ANY POTENTIAL INSULATION DEFECTS, BUT NO PROBLEMS WERE FOUND. THE CONCLUSION REACHED BY CO WAS THE INCIDENT DEVICE WAS OPERATING PROPERLY AND HAD NO DISCERNABLE DEFECTS IN THE INSULATION. APPARENTLY THE INCIDENT CONDITIONS ALLOWED A SUFFICIENT LEVEL OF LEAKAGE THROUGH THE INSULATION IN THE AREA TOUCHING THE METAL MAYO STAND TO CREATE THE RF PATH RESULTING IN THE INJURY TO THE NURSE. WITH NO INSULATION DAMAGE OBSERVED AND THE CABLE PASSING ALL RELEVANT REQUIREMENTS, THE ABSOLUTE CAUSE OF THE INCIDENT WAS NOT DETERMINED. THESE DEVICES ARE VISUALLY EXAMINED FOR SEVERAL DETAINS DURING PRODUCTION AND ANY INSULATION DAMAGE DETECTED WOULD HAVE BEEN CAUSE FOR REJECTION. NO FURTHER ACTION IS ANTICIPATED AS THIS INCIDENT IS AN ISOLATED CASE OF LEAKAGE.
THE LEAD WAS EXPLANTED ELECTIVELY. FAILURE ANALYSIS INDICATES THE LEAD IS FRACTURED WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAD FRACTURED AT WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX 87 MM AND WAS APPROX 11MM OF THE DISTAL END PROTRUDING OUT OF THE OUTER POLYURETHANE INSULATION APPROX 1MM PROXIMAL OF SELD SITE. IT APPEARS THAT THE ENTIRE J   STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASURMENTS ADDING UP TO 87 MM. VISUAL INSPECTON UNDER 30X MAGNIFICATION ALSO INDIDCATES THE LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURE.
A CRITICALLY ILL PT WITH A BALLOON PUMP WAS TRANSFERRED FROM SURGERY TO THE ICU POST OPEN HEART. AN INFUSION OF DOPAMINE WAS STARTED IN THE OR. AFTER THE TRANSFER, THE INFUSION RATE FOR THE DOPAMINE DRIP WAS REPEATEDLY INCREASED FOR LOW B/P WITHOUT RESPONSE. OTHER IV SOLUTIONS WERE JOINED WITH A SEQUENCE OF STOPCOCKS TO A COMMON CENTRAL LINE PORT. IT WAS THEN OBSERVED THAT THE DOPAMINE SOLUTION CONTAINER WAS VERY DISTENDED AND IT WAS NOTED THAT THE IV TUBING WAS LOADED BACKWARDS THROUGH THE INFUSION PUMP. WHEN A NEW CONTAINER OF DOPAMINE WAS HUNG AND THE IV TUBING WAS LOADED CORRECTLY THE PT'S B/P RESPONDED APPROPRIATELY. NO ADD'L PT INTERVENTION RELATING TO THE OCCURRENCE WAS REQUIRED. THE SPECIFIC S/N FOR THE INFUSION PUMP WAS NOT REPORTED.
SECTION F COMPLETED BY THE MFR. THE SPECIFIC INFUSION PUMP INVOLVED WAS NOT INDENTIFIED. A DIAGRAM ON THE INFUSION PUMP DISPLAYS THE PROPER ORIENTATION FOR LOADING THE IV TUBING THROUGH THE INFUSION PUMP.
RPTR STATED, REVISION SURGERY REVEALED LOOSENING OF THE BASEPLATE. DURING THE SURGERY, THE TIBIAL INSERTS WOULD NOT SEAT PROPERLY IN THE REVISION BASEPLATE. A NEW BASEPLATE AND INSERT WEE CHOSEN AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
SUMMARY OF EVAL: THE TIBIAL BASEPLATE AND TIBIAL INSERTS WERE VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE BASEPLATE IS IN NEW CONDITION. THE ANTERIOR LOCKING TAB OF EACH OF THE INSERTS EXHIBITS INSIGNIFICANT DISTORTION AS A RESULT OF THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. A DIMENSIONAL INSPECTION OF THE BASEPLATE FOUND THAT ALL DIMENSIONS RELATING TO INSERT MATING MET DESIGN REQUIREMENTS. THE INSERTS WERE ASSEMBLED IN THE AS-RECEIVED CONDITION TO THE RETURNED BASEPLATE USING TWO-THUMBS PRESSURE. RESULTS FOR ALL THREE INSERTS WERE A CRISP SNAP ACTION WITH FULL, TIGHT SEATING. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS BASEPLATE AND INSERTS FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MANUFACTURE. THE EVAL RESULS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES.
THE ANTERIOR LOCKING MECHANISM ON THE TIBIAL INSERT WOULD NOT ENGAGE THE BASEPLATE. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SECTION F1-14 HAS BEEN COMPLETED BY MFR.
ON 9/9/96, CO RECEIVED INFO ALLEGING THAT ANOTHER PULSE OXIMETRY MODULE BEING USED WITH CO'S DISPOSABLE OXYGEN TRANSDUCER DISPLAYED AN OXYGEN SATURATON READING OF 80-90% ON AN 8-10 KG 1 YEAR OLD FEMALE WITH DOWN'S SYNDROME WHO WAS IN RECOVERY FROM CARDIAC SURGERY FOR A CONGENITAL HEART DEFECT. ACCORDING TO THE HOSP, AN ABG TEST WAS PERFORMED PRIOR TO MAKING ANY CHANGES IN THE PT'S VENTILATOR SETTINGS. THE HOSP CALCULATED THE ABG TEST RESULTS TO AN OXYGEN SATURATION SAID TO BE "IN THE 50'S." THE HOSP STAFF THEN CHANGED THE SENSOR SITE TO A DIFFERENT FINGER ON THE SAME HAND. THE OXYGEN SATURATION READING DISPLAYED ON THE OTHER CO'S OXIMETRY MODULE THEN CORRELATED TO THE ABG TEST RESULTS, DISPLAYING AN OXYGEN SATURATION READING OF 56%. THE PT EXPIRED TWO DAYS AFTER THIS EVENT. THE HOSP STAFF HAS EXPRESSED THEIR BELIEF THAT "THE SENSOR REPORT WAS IN NO WAY RELATED (TO THE PT'S OUTCOME)." THE DEVICE IS NOT INTENDED FOR USE ON PTS WEIGHING 8-10 KGS. ADDITIONALLY, THE PREFERRED SITE OF APPLICATIONS AS STATED IN THE DIRECTIONS FOR USE OF THE CORRECT SENSOR FOR THIS PT IS THE GREAT TOE OF THE FOOT. THE DEVICE'S DIRECTIONS FOR USE STATE: "FOR NEONATES WEIGHING LESS THAN 3 KG OR ADULTS WEIGHING MORE THAN 40 KGS." THE DEVICE'S DIRECTIONS FOR USE ALSO WARNS: "FAILURE TO APPLY THE DEVICE PROPERLY MAY CAUSE INCORRECT MEASUREMENTS."
CO'S CLINICAL LABORATORY CONDUCTED A SATURATION ACCURACY VERIFICATION TEST OF THE DEVICE RETURNED BY THE HOSP. THIS TEST USES ACTUAL BLOOD SAMPLES AT CONTROLLED OXYGEN SATURATION LEVELS THAT ARE PULSED THROUGH AN ARTIFICIAL "FINGER." THE RESULTS OF THIS TEST CONCLUDE THAT THE DEVICE RETURNED BY THE HOSP MEETS CO'S ACCEPTANCE CRITERIA FOR SATURATION ACCURACY. CO WILL OFFER EDUCATIONAL ASSISTANCE TO THIS CUSTOMER REGARDING THE CORRECT USE OF CO'S PRODUCTS. OTHER CO HAS BEEN NOTIFIED OF THIS EVENT.
PT POST BILATERAL PELVIC LYMPH NODE DISSECTION WITH FROZEN SECTION, RADICAL RETROPUBIC PROSTATECTOMY. FOLEY WITH CONTINUOUS BLADDER IRRIGATION INSERTED IN OR WITHOUT DIFFICULTY. IN PACU, FOLEY WAS FOUND OUT OF PT AND LYING ON STRETCHER. BALLOON OF FOLEY EXAMINED BY PHYSICIAN AND FOUND TO HAVE A LEAK. PT UNDERWENT A FLEXIBLE CYSTOSCOPY WITH INSERTION OF ANOTHER FOLEY OVER A GUIDE WIRE.
STAFF MEMBERS ATTEMPT TO DEFIBRILLATE A PT (AGE AND GENDER UNK) DURING AN OPEN HEART PROCEDURE. WHEN THE STAFF PRESSED THE DISCHARGE BUTTONS ON THE PADDLES, A "PADDLE FAULT" MESSAGE APPEARED ON THE UNIT'S MONITOR SCREEN. THE STAFF CHARGED THE UNIT A SECOND TIME, BUT THE UNIT WOULD NOT DISCHARGE. THE STAFF OBTAINED ANOTHER SET OF PADDLES AND CONVERTED THE PT'S RHYTHM. THERE WAS NO ADVERSE EFFECT ON THE PT.
DRILL BITS BROKEN DURING OPERATIVE (DENTAL) PROCEDURE. RETRIEVED BY ORAL SURGEON.
PT SUSTAINED A THIRD DEGREE BURN AT THE SITE OF A CAUTERY GROUND PAD ON THE THIGH. BURN APPROX 3" REQUIRING SURGICAL INTERVENTION/GRAFT. THIS WAS A USER ERROR. PAD WAS PLACED OVER SUPPORT HOSE. IN HOUSE EVAL FOUND PRODUCT TO BE OPERATING PROPERLY.
THE PT TABLE STARTED TILTING INTO THE TRENDELENBURG POSITION WHEN THE "PT LIFT UP" BUTTON WAS PRESSED. THE OPERATOR USED THE E-STOP BUTTON TO STOP FURTHER TABLE MOTION.
AFTER 20 MINS OF HAVING PAD APPLIED TO HER BACK, THE PT WAS NOTED TO HAVE BLISTERS. IT IS UNCERTAIN WHETHER THE BLISTERS WERE THERE PRIOR TO APPLICATION. THE EQUIPMENT CHECKED OUT AS FUNCTIONING PROPERLY. THE PAD WAS ON THE PT WITH THE PLASTIC SIDE TOUCHING THE SKIN.
A RADIOPAQUE MARKER DETACHED IN A VISCERAL ABCESS DURING A DRAINAGE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS UNIT. NO RETRIEVAL ATTEMPTS WERE NECESSITATED. THE PHYSICIAN FEELS THE MARKER IS SECURE. THE PT'S CONDITION IS FINE. THIS DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. THE PT'S ANATOMY AND/OR CONDITION MAY HAVE BEEN A CONTRIBUTING FACTOR TO THIS EVENT. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE CAUSE FOR THIS EVENT.
A BALLOON BURST DURING AN AORTIC VALVULOPLASTY PROCEDURE AND BEGAN TO SEPARATE FROM THE CATHETER SHAFT. THE BALLOON CATHETER AND INTRODUCER SHEATH WERE REMOVED AS A UNIT WITHOUT INCIDENT. A SECOND BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PT COMPLICATIONS. THIS DEVICE IS CURRENTLY BEING INVESTIGATED BY CO'S ENGINEERS. UPON COMPLETION OF THE ENGINEERING EVALUATION, A SUPPLEMENTAL MEDWATCH FORM WILL BE FORWARDED UNDER THE ABOVE NOTED SEQUENCE NUMBER. CO'S DIRECTIONS FOR USE STATE: "IF A BALLOON RUPTURES WHILE IN USE AND RESISTANCE IS FELT WHEN WITHDRAWING IT THROUGH A SHEATH, THEN THE SHEATH AND BALLOON SHOULD BE REMOVED TOGETHER."
F11. DATE MFR INITIALLY FORWARDED REPORT TO FDA. H3. EVALUATION SUMMARY: THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE SHAFT WAS CUT 13.7 CENTIMETERS FROM THE DISTAL TIP. THE REMAINDER OF THE SHAFT WAS NOT RETURNED. THE BALLOON EXHIBITED A LONGITUDINAL BURST STARTING AT ONE CENTIMETER FROM THE DISTAL END OF THE PROXIMAL RADIOPAQUE MARKER TO 1.4 CENTIMETERS PROXIMAL TO THE DISTAL RADIOPAQUE MARKER. AT THE PROXIMAL AND DISTAL ENDS OF THE MATERIAL THERE WERE 5 MILLIMETER CIRCUMFERENTIAL TEARS ALL BALLOON MATERIAL APPEARED TO BE PRESENT. FOLLOW UP INDICATED THE CATHETER SHAFT WAS CUT AFTER TEH PROCEDURE WAS COMPLETE. WITHOUT BEING ABLE TO EXAMINE THE ENTIRE DEVICE, A THORUOUGH EVALUATION COULD NOT BE PERFORMED. THEREFORE CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. H6. 86/OTHER - MICROSCOPIC EVALUATION.
ANGIOPLASTY BALLOON RUPTURED NECESSITATING SURGICAL INTERVENTION TO REMOVE FRAGMENTS. PT SEEMS TO HAVE TOLERATED PROCEDURE WELL.
STAFF MEMBERS WERE TREATING A PT (AGE AND GENDER UNK) WHO REQUIRED DEFIBRILLATION DURING A SURGICAL PROCEDURE. WHEN THEY PRESSED THE CHARGE BUTTON, THE UNIT DID NOT CHARGE. THE STAFF OBTAINED A SECOND SET OF INTERNAL PADDLES AND CONVERTED THE PT'S RHYTHM. THERE WAS NO ADVERSE EFFECT ON THE PT.
UPON OPENING A BOTTLE OF TEST STRIPS. USER NOTICED THAT THE TEST PAD AREAON ALL OF THE TEST STRIPS WAS A DARK BROWN COLOR. HE DID NOT ATTEMPT TO PERFORM ANY BLOOD GLUCOSE TESTS OR CONTROL TESTS. HE IS NOT COMFORTABLE USING DISCOLORED PRODUCT. CO'S INVESTIGATION OF THIS COMPLAINT HAS NOT BEEN COMPLETED. ESTIMATED TIME TO COMPLETION IS 4 WEEKS. FURTHER INFO WILL BE PROVIDED AT THAT TIME.
IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? U. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? U. IS EVENT OCCURING WITH GREATER SEVERITT THAN IS USUAL FOR DEVICE? N.
THE PT UNDERWENT A THORACOTOMY AND DECORTICATION FOR BILATERAL PERSISTANT PLEURAL EFFUSIONS ON 3/15/96, AND REQUIRED INTUBATION POSTOPERATIVELY. THE PT HAS SINCE BECOME VENTILATOR DEPENDENT. ON 3/29/96, THE EXTERNAL ATTACHMENT USED TO INFLATE THE CUFF OF THE ENDOTRACHEAL TUBE DETACHED THUS DEFLATING THE ENDOTRACHEAL CUFF. THE PT HAD AN EMESIS AND ASPIRATED. THE PT REQUIRED IMMEDIATE REINTUBATION. FURTHER ATTEMPTS TO WEAN THE PT FROM THE VENTILATOR WERE DELAYED.
LEAKAGE DURING TRIAL INFLATION (BALLOON).
REPORT RECEIVED INDICATING THAT DURING TRIAL INFLATION, BALLOON LEAKAGE WAS NOTED. THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAM: UPON RECEIPT, THE CATHETER WAS COILED WITHIN A PLASTIC BAG WITH A 3 CC SYRINGE. FUNCTIONAL TESTING: THE BALLOON WAS INFLATED WITH WATER USING THE RETURNED 3 CC SYRINGE; LEAKAGE WAS NOTED EMANATING FROM A SMALL CRACK IN THE LATEX BALLOON MATERIAL. MICROSCOPIC EXAM: LIGHT OPTICAL EXAM OF THE BALLOON REVEALED EVIDENCE OF SOME MATERIAL DEGRADATION. THE BALLOON MATERIAL APPEARED TO BE DEGRADED BY ATMOSPHERIC AGENTS OVER TIME. THE DEGRADATION OF THE MATERIAL APPEARS TO BE RELATED TO STORAGE CONDITIONS. THE MEDICAL GRADE LATEX BALLOON DETERIORATES WHEN EXPOSED TO HEAT OR LIGHT. PER CO INSTRUCTIONS FOR USE, THE BALLOON SHOULD BE STORED IN A COOL AND DRY PLACE. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON LEAKAGE COULD NOT BE DETERMINED, IT IS SUSPECTED TO BE RELATED TO STORAGE CONDITIONS.
MELTED PLASTIC FROM THE CAP SLEEVE FOUND BLOCKING THE PORT. RESULTING IN OVERHEATING AND A CORNEAL BURN TO THE PT.
A PT WAS ADMITTED TO THE EMERGENCY ROOM WITH SEVERE ESOPHAGEAL BLEEDING. THE PHYSICIAN INTUBATED THE PT AND THEN LOADED A MULTI-BAND LIGATOR ON TO A LUBRICATED ENDOSCOPE. DURING THE POSITIONING OF THE ENDOSCOPE, THE MULTI-BAND LIGATOR SLIPPED OFF THE ENDOSCOPE. AN UNSUCCESSFUL ATTEMPT WAS MADE TO REPOSITION THE MULTI-BAND LIGATOR BACK ON THE ENDOSCOPE. FACED WITH THE URGENCY OF THE SITUATION, THE PHYSICIAN CUT THE TRIGGER CORD AND PUSHED THE MULTI-BAND LIGATOR AND THE REMAINING PORTION OF THE TRIGGER CORD INTO THE PT'S STOMACH. THE PROCECURE WAS COMPLETED AND THE SCLEROTHERAPY WAS ADMINISTERED TO STOP THE BLEEDING. THE PT PASSED THE BARREL AND THE TRIGGER CORD THE NEXT DAY WITH NO COMPLICATIONS. THE PT IS IN SATISFACTORY CONDITION.
THIS REPORT IS BASED ENTIRELY ON UNCONFIRMED INFO SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENDED TO BE AN ADMISSION THAT ANY WILSON-COOK DEVICE (I) IS DEFECTIVE OR MALFUNCTIONS OR (II) CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. CO DOES NOT BELIEVE THAT THIS REPORTED INCIDENT IS LIKELY TO REOCCUR.
A CORNEAL BURN OCCURRED DURING PROCEDURE. THERE WAS NO INTERVENTION AND THE REPORTER INDICATED THAT IT SHOULD RESOLVE WITHOUT PERMANENT INJURY. THE DOCTOR WANTS THE UNIT AND THE HANDPIECE EVALUATED.
A CO SERVICE REP. CHECKED THE SYSTEM AND THE HANDPIECE AND FOUND THEM BOTH TO MEET THEIR PERFORMANCE SPECIFICATIONS. PT IN HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED TO DATE. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
DURING PROCEDURE MD REPORTED LOW/NO VACCUM IN PHACO AND THEN SLIGHT CORNEAL BURN.
A CO SERVICE REP. CHECKED THE SYSTEM AND FOUND IT TO MEET ITS PERFORMANCE SPECIFICATIONS. NO CONSUMABLES WERE SAVED FOR EVAL. PT INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
CATHETER INSERTED 5/23/94. SHEARING OF CATHETER NECESSITATED RETRIEVAL OF DISTAL PORTION ON 2/21/96 FROM RIGHT PULMONARY ARTERY AND RETRIEVAL OF PROXIMAL PORTION ON 3/1/96 FROM RIGHT SHOULDER.
PT WAS GIVEN TREATMENT FOR FIELDS 1 AND 2, AFTER THE SECOND FIELD TREATMENT THE FIRST FIELD WAS SHOWN AS OPEN FOR TREATMENT AND WOULD ALLOW ADD'L TREATMENT. ON AUGUST 20, 1996, A PT FILE WAS CREATED AT THE CO STATION (NEXT TO THE LINEAR ACCELERATOR) WITH FIELD 1. THIS FIELD WAS THEN TREATED. A SECOND FIELD (FIELD 2) WAS CREATED AND TREATED. THE SECOND FIELD WAS CREATED WITHOUT THE USE OF CONTROL C (COPY FIELD FUNCTION). IT WAS THEN NOTICED THAT THE FIRST FIELD INDICATED IT WAS AVAILABLE FOR TREATMENT WITHOUT THE FIELD BEING CALLED UP FOR TREATMENT AGAIN. THE PT FILE SHOWS FIELD 1 DID ACCUMULATE ITS DAILY DOSE BUT THIS FIELD DOES NOT SHOW ON THE TREATMENT HISTORY. THE LOG LIST SHOWS THAT BOTH FIELDS HAD BEEN TREATED NORMALLY. THERE WERE NO EDIT DOSES PERFORMED ON THIS PT.
THE CUSTOMER'S DATABASES WERE DOWNLOADED TO THE CO OFFICE THE DAY OF REPORTED INCIDENT. THE NEXT DAY, CO STATION WAS SETUP USING THE CUSTOMER'S PARAMETER FILES. BY SETTING THE CLOCK BACK ON THE CO STATION CO WAS ABLE TO SEE WHAT THE CUSTOMER SAW ON THE PREVIOUS DAY. UPON REVIEW OF THE CUSTOMER'S DATABASES, FIELD NUMBER ONE WAS SHOWN TO HAVE AN ARROW NEXT TO IT INDICATING IT WAS AVAILABLE FOR TREATMENT. AT THIS POINT, THE CUSTOMER'S PARAMETER FILES WERE MODIFIED TO ALLOW THE USE OF AN ACCELERATOR SIMULATOR FOR FURTHER INVESTIGATIONS. WITH THE USE OF THE ACCUMULATED TWICE ITS DAILY DOSE (800CGY). FIELD ONE WAS THEN CLOSED OUT AND THE TREATMENT FIELD NUMBER 0 IN THE TREATMENT FIELD (THIS IS AN ERROR BECAUSE, TREATMENT FIELD NUMBER 0 IS INVALID). THERE WAS NO INTEGRATOR ERRORS ASSOCIATED WITH THIS RECORD BUT THERE WAS ONE DATABASE ERROR. THE TIME ON THIS DATABASE ERROR INDICATES THAT IT OCCURRED AFTER THE FIRST FIELD WAS TREATED. FURTHER ATTEMPTS TO REPRODUCE THIS PROBLEM WERE UNSUCCESSFUL. THE PROBLEM HAS NOW BEEN TURNED OVER TO THE CO'S RESEARCH & DEVELOPMENT DEPT FOR FURTHER EVALUATION. NO DEFINITE CONCLUSION CAN BE DRAWN AT THIS TIME BECAUSE NOTHING HAS BEEN FOUND THAT CAUSES THIS PROBLEM. CO'S RESEARCH AND DEVELOPMENT DEPT IS CONDUCTING AN ONGOING INVESTIGATION INTO THIS PROBLEM  TO ASCERTAIN THE CAUSE AND A SOLUTION.
THE PERCUTANEOUS TRACHEOSTOMY TUBE WAS IN USE FOR AN UNKNOWN PERIOD OF TIME WHEN THE PT BECAME HYPERCARBIC. VIEWING THROUGH A BRONCHOSCOPE, THE CLINICIAN NOTED A PARTIAL OBSTRUCTION AT THE TIP OF THE TRACHEOSTOMY TUBE WHICH WAS THOUGHT TO BE THE LEFT LATERAL TRACHEAL MUCOSA. THE TUBE WAS REMOVED AND REPLACED WITH A DIFFERENT STYLE TUBE AND THERE WAS NO PT INJURY.
THE SUBMISSION OF THIS OR ANY OTHER INFORMATION TO THE FOOD AND DRUG ADMINISTRATION BY SIMS, INC. PURSUANT TO 21 C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFORMATION, DOES NOT CONSTITUTE AN ADMISSION BY THE COMPANY THAT A SIMS DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. NI ENTRY THROUGHOUT THE FORM-CO HAS CONTACTED THE USER FACILITY ON SEVERAL OCCASIONS AND THEY ARE STILL GATHERING INFO ON THIS EVENT. H.6 (METHOD) CODE 86 OTHER: VISIT TO USER FACILITY BY CO'S PERSONNEL ON 10/30/96. H.6 (CONCLUSION) CODE 62: CO HAS CONCLUDED THAT CLINICIAN CHOICE OF TUBE SIZE MAY BE A CONTRIBUTING FACTOR TO THIS EVENT.
THE PHYSICIAN WAS PERFORMING A BAND LIGATION IN THE LOWER ESOPHAGUS, USING A MULTI-BAND LIGATOR. THE VARICIES WERE SUCTIONED INTO THE BARREL AND SUCCESSFULLY BANDED. THE PHYSICIAN PREPARED TO DO A SECOND BANDING AND WAS UNABLE TO ADVANCE THE ENDOSCOPE BEYOND THE BANDED AREA. A BARIUM SWALLOW WAS ADMINISTERED AND IT WAS NOTED THE LOWER ESOPHAGUS WAS BANDED SHUT. THE PT WAS MONITORED AND THREE DAYS LATER THE BAND AND VARICIES HAD SLOUGHED OF AND THE ESOPHAGUS WAS OPEN. THE PT IS IN SATISFACTORY CONDITION.
THIS REPORT IS BASED ENTIRELY ON UNCONFIRMED INFO SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENDED TO BE AN ADMISSION THAT ANY WILSON-COOK DEVICE (I) IS DEFECTIVE OR MALFUNCTONED OR (II) CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. CO DOES NOT BELIEVE THAT THIS REPORTED INCIDENT IS LIKELY TO REOCCUR.
A 55-YR-OLD FEMALE UNDERGOING LAPAROSCOPICALLY ASSISTED HYSTERECTOMY. AFTER PLACEMENT OF CANNULA AND DILATOR WITH RADIALLY EXPANDABLE SLEEVE, BLEEDING WAS NOTED IN THE RIGHT LOWER QUADRANT OF THE PELVIS NECESSITATING CONVERSION OF PROCEDURE TO LAPAROTOMY. A SMALL INJURY TO THE MESENTERY OF THE COLON WAS REPAIRED. THE PT WAS DISCHARGED ON 3/8/96 IN STABLE CONDITION.
REPORT OF ALLEGED "ALL LEDS ON CONSTANT SINGLE TONE ALARM, NO VOLUME DELIVERED. OCCURRED DURING NIGHT. CONSTANT HIGH PRESSURE ALARMS SOUNDING. NO PT HARM.
TESTING BY MFR DID NOT CONFIRM THE REPORTED NO VOLUME DELIVERY CONDITION.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE AND WAS REMOVED FULL INFLATED. NO PT INJURIES OR COMPLICATIONS.
RETURNED PRODUCT ANALYSIS REVEALED A KINK IN THE INFLATION LUMEN OF THE CATHETER SHAFT. THE KINK MAY HAVE RESTRICTED FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE KINK OR WHEN IT OCCURRED COULD NOT BE DETERMINED.
A UNIT SUPPORT AID WAS CARRYING A BAG OF TRASH WITH IV SETS. A CONVERTIBLE PIERCING PIN POKED THROUGH THE PLASTIC BAG AND POKED THE AID IN THE LEG AND DREW BLOOD. THE AID WAS SEEN IN THE ER AND IS GOING THROUGH AIDS COUNSELING. AN INCIDENT REPORT WAS WRITTEN CLAIMING THAT THE SPIKE ON THE CONV. PP WAS SHARP AND POKED THE AID'S LEG. THE HOSPITAL HAS REVIEWED ITS POLICY FOR DISPOSAL OF WASTES. THIS BAG WAS UNLABELED AND, THEY ARE NOT CERTAIN IF THE PIERCING PIN HAD EVEN BEEN USED ON A PT.
THE PERCUTANEOUS TRACHEOSTOMY TUBE WAS IN USE FOR 8 DAYS WHEN THE PT BECAME HYPERCARBIC. VIEWING THROUGH A BRONCHOSCOPE, THE CLINICIAN NOTED A PARTIAL OBSTRUCTION AT THE TIP OF THE TRACHEOSTOMY TUBE WHICH WAS THOUGHT TO BE THE LEFT LATERAL TRACHEAL MUCOSA. THE TUBE WAS REMOVED AND REPLACED WITH A DIFFERENT STYLE TUBE AND THERE WAS NO PT INJURY.
THE SUBMISSION OF THIS OR ANY OTHER INFORMATION TO THE FOOD AND DRUG ADMINISTRATION BY SIMS, INC. PURSUANT TO 21 C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFORMATION, DOES NOT CONSTITUTE AN ADMISSION BY THE COMPANY THAT A SIMS DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. NI ENTRY THROUGHOUT THE FORM-CO HAS CONTACTED THE USER FACILITY ON SEVERAL OCCASIONS AND THEY ARE STILL GATHERING INFO ON THIS EVENT. H.6 (METHOD) CODE 86: OTHER: VISIT TO USER FACILITY BY CO PERSONNEL ON 10/30/96. H/6 (CONCLUSION) CODE 62: CO HAS CONCLUDED THAT CLINICIAN CHOICE OF TUBE SIZE MAY BE A CONTRIBUTING FACTOR TO THIS EVENT.
AT IMPLANT, THE PT'S NATIVE VALVE WAS SEVERELY CALCIFIC AND BICUSPID. PT HAD UNEVENTFUL POSTOPERATIVE COURSE AND WAS DISCHARGED ON ORAL ANTICOAGULANTS. THE PT WAS ADMITTED THREE WEEKS LATER WITH EVIDENCE OF STROKE. ECHO DID NOT REVEAL CLOTS. THE PT'S CONDITION DETERIORATED AND HE EXPIRED. POSTMORTEM REVEALED THROMBUS OCCLUDING ONE LEAFLET.
DEVICE NOT RETURNED. THE VALVE'S DEVICE HISTORY RECORD WAS EXAMINED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE, INDICATING THAT THE PROCESS WAS PERFORMED IN ACCORDANCE WITH CO'S SPECIFICATIONS. EACH OPERATION FOR THE MANUFACTURING AND INSPECTION OF THIS VALVE WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE. RESULTS OF THIS INVESTIGATION REMAIN INCONCLUSIVE DUE TO THE FACT CO HAS NOT RECEIVED THE VALVE FOR TESTING OR ADD'L INFO WHICH MAY HAVE AIDED IN THE EVALUATION OF THIS CASE. SHOULD THE VALVE BE RETURNED FOR TESTING, THIS FILE SHALL BE RE-OPENED FOR FURTHER INVESTIGATION.
CATHETER BECAME DETACHED FROM PORT AND MIGRATED TOWARD HEART. DEVICE REMOVED UNDER FLUOROSCOPY.
RETURNED PRODUCT ANALYSIS VERIFIED SLOW DEFLATION OF THE BALLOON. ANALYSIS ALSO REVEALED THE CATHETER SHAFT WAS KINKED AND TWISTED. THE CONDITION OF THE SHAFT MAY HAVE CONTRIBUTED TO THE DEFLATION DIFFICULTY. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED.
PT HAD HISTORY OF LEFT ATRIAL CLOTS AT TIME OF THE VALVE IMPLANT. POSTOPERATIVE COURSE WAS UNEVENTFUL. DUE TO A SUSPICION OF THROMBUS ON THE VALVE IN AUGUST, STREPTOKINASE WAS ADMINISTERED. THE PT'S CONDITION RAPIDLY DETERIORATED, AND THE PT EXPIRED. POSTMORTEM REVEALED THROMBUS ON THE ATRIAL ASPECT OF THE PROSTHETIC VALVE.
DEVICE NOT RETURNED. THE VALVE'S DEVICE HISTORY RECORD WAS EXAMINED TO ENSURE THAT EACH MANFUACTURING AND INSPECTION OPERATION WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE, INDICATING THAT THE PROCESS WAS PERFORMED IN ACCORDANCE WITH CO'S SPECIFICATIONS. EACH OPERATION FOR THE MANUFACTURING AND INPSECTION OF THIS VALVE WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE. RESULTS OF THIS INVESTIGATION REMAIN INCONCLUSIVE DUE TO THE FACT CO HAS NOT RECEIVED THE VALVE FOR TESTING OR ADDITIONAL INFO WHICH MAY HAVE AIDED IN THE EVALUATION OF THIS CASE. SHOULD THE VALVE BE RETURNED FOR TESTING, THIS FILE SHALL BE RE-OPENED FOR FURTHER INVESTIGATION.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED. ANALYSIS SHOWS THAT THIS CALIBRATION CODE, IF USED TO PERFORM AN ASSAY WITH TEST STRIPS FROM ANY LOT COULD RESULT IN HIGHER THAN EXPECTED VALUES. NO INJURIES REPORTED IN THE FIELD.
ALL AVAILABLE TESTING OF THE RETURNED SENSOR WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPECIFICATION.
THE BALLOON WOULD NOT INFLATE. THE BALLOON WAS THEN INFLATED TO 20 ATM (RBP=18 ATM), BUT THE DEFLATION WAS SLOW. NEGATIVE PRESSURE WAS APPLIED UNTIL THE BALLOON DEFLATED ENOUGH TO REMOVE. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS CONFIRMED THE REPORTED DEFLATION DIFFICULTIES.  THE CATHETER REVEALED A KINK IN THE INFLATION LUMEN CLOSE TO THE DISTAL END. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED.
RETURNED PRODUCT ANALYSIS REVEALED A KINK IN THE INFLATION LUMEN LOCATED NEAR THE DISTAL TIP. THE BALLOON AND SHAFT WERE FILLED WITH RESIDUAL DRIED CONTRAST MEDIA SO TESTING RELATIVE TO THE REPORTED DEFLATION DIFFICULTIES COULD NOT BE PERFORMED. THE KINK IN THE SHAFT MAY HAVE RESTRICTED FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED.
INTUBATION WITH THE PERCUTANEOUS TRACHEOSTOMY TUBE WAS DIFFICULT REQUIRING THREE ATTEMPTS. SOMETIME AFTER PLACEMENT, THE PT'S INSPIRATORY PRESSURE WAS NOTED AS BEING TOO HIGH. VIEWING THROUGH A BRONCHOSCOPE, THE TRACHEOSTOMY TUBE WAS REPOSTIONED AND THERE WERE NO FURTHER DIFFICULTIES.
THE SUBMISSION OF THIS OR ANY OTHER INFORMATION TO THE FOOD AND DRUG ADMINISTRATION BY SIMS, INC. PURSUANT TO 21 C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFORMATION, DOES NOT CONSTITUTE AN ADMISSION BY THE COMPANY THAT A SIMS DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. NI ENTRY THROUGHOUT THE FORM-CO HAS CONTACTED THE USER FACILITY ON SEVERAL OCCASIONS AND THEY ARE STILL GATHERING INFORMATION ON THIS EVENT. H.6 (METHOD) CODE 86 OTHER: VISIT TO USER FACILITY BY CO'S PERSONNEL ON 10/30/96. H.6 (CONCLUSION) CODE 62: CO HAS CONCLUDED THAT CLINICIAN CHOICE OF TUBE SIZE MAY BE A CONTRIBUTING FACTOR TO THIS EVENT.
PT HAD HISTORY OF SEVERE AORTIC REGURGITATION. POSTOPERATIVE COURSE WAS UNEVENTFUL. PT WAS ON ANTICOAGULATION. REOPERATION PERFORMED REVEALED AORTIC PROSTHESIS COMPLETELY BLOCKED WITH FRESH, ORGANIZED THROMBUS. PT EXPIRED POSTOPERATIVELY THE SAME DAY DUE TO PROGRESSIVE LEFT VENTRICULAR FAILURE.
DURING SERVICE OF PRODUCT, A CONTINUOUS CYCLE, NO VOLUME DELIVERED, WITH AUDIBLE AND VISUAL ALARMS WAS FOUND, DUE TO 1ST STAGE GEAR BEING OUT OF SPECIFICATION. REPLACED 1ST STAGE GEAR.
PT WAS WEARING A POSEY VEST. SHE SLID DOWN INTO THE SEAT OF A WHEELCHAIR AND THE SEATBELT WAS AROUND HER CHEST; WHEN THE NURSE FOUND HER SHE WASS CYANOTIC; SEATBELT WAS RELEASED TO FREE THE PT. PT WAS CHECKED BY PHYSICIAN WHO NOTED A RED SPOT ON HER POSTERIOR. PT WAS RELEASED.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT FULLY DEFLATE. THE BALLOON DEFLATED ENOUGH TO REMOVE. NO PT INJURIES OR COMPLICATION OCCURRRED. SAME CASE AS MFR. REPORT NO. 2183819-1996-00016.
RETURNED PRODUCT ANALYSIS REVEALED A CRACK IN THE MANIFOLD'S LUER PORT. THE CRACK ALLOWED FLUID TO LEAK FROM THE CATHETER AND MAY HAVE CONTRIBUTED TO THE DEFLATION DIFFICULTY STATED IN THE COMPLAINT. THE CAUSE OF THE LUER PORT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED. SAME CASE AS MFR. REPORT NO. 2183819-1996-00016.
T-CONNECTOR DISENGAGED FROM PT'S CATHETER. THE PT LOST AN UNDETERMINED AMOUNT OF BLOOD. THE BLOOD LOSS SATURATED A CLOTH DIAPER (THE AREA UNDER THE PT'S HEAD) AS WELL AS A COTTON BALL AND TAPE. THE T-CONNECTOR WAS RECONNECTED AND FLUSHED. NO FURTHER PROBLEMS WITH T-CONNECTOR WERE NOTED. THE PT RECEIVED 15CC/KG OF PACKED RED BLOOD CELLS TIMES TWO. BEFORE THE INDICENT, HCT WAS 39.3. IMMEDIATELY ATER IT WAS 24.9 AND AFTER THE TRANSFUSION IT WAS 40.6. THE PT IS NOW OKAY.
PLAINTIFF ALLEGES SEVERE SENSITIVITY TO LATEX CAUSED BY EXPOSURE TO EXCESSIVE LEVELS OF ALLERGENIC PROTEINS IN LATEX EXAM GLOVES.
THE INVESTIGATION COULD BE PERFORMED AS THE REPORTER DID NOT PROVIDE ANY PRODUCT CODE OR LOT NUMBER INFO. LITIGATION PENDING NO CUSTOMER ALLOWED.
DURING SERVICE OF PRODUCT DEVICE WAS FOUND TO NOT CYCLE WITH ALL LEDS ON AND A CONSTANT SINGLE TONE ALARM, DUE TO TRANSISTOR Q7 ON THE MOTOR BOARD BEING OUT OF SPECIFICATION. REPLACED Q7.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT FULLY DEFLATE. THE BALLOON DEFLATED ENOUGH TO REMOVE. NO PT INJURIES OR COMPLICATIONS OCCURRED. SAME CASE AS MFR REPORT NO.00015.
RETURNED PRODUCT ANALYSIS REVEALED A LEAK ASSOCIATED WITH THE PLUNGER. THE LEAK MAY HAVE CONTRIBUTED TO THE REPORTED DEFLATION DIFFICULTIES. SAME CASE AS MFR. REPORT NO. 24005.
DURING A POST STENT DILATATION PROCEDURE, THE BALLOON CATHETER BECAME CAUGHT. AFTER APPROXIMATELY FIVE MINUTES, THE BALLOON CATHETER WAS REMOVED. UPON REMOVAL IT WAS NOTICED THAT THE BALLOON WAS WINGED. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED THE BALLOON OF THE RETURNED CATHETER DID EXHIBIT WINGING. THE BALLOON MATERIAL DID NO REWRAP ITSELF WHEN NEGATIVE PRESSURE WAS APPLIED TO THE SYSTEM. THE ABILITY OF THE MATERIAL TO REWRAP IS DIRECTLY DEPENDENT ON SEVERAL FACTORS SUCH AS TEMPERATURE, THE LENGTH OF TIME THE CATHETER IS INFLATED, AND INFLATION PRESSURE. IT IS POSSIBLE THAT A COMBINATION OF THESE FACTORS WAS ENOUGH TO CAUSE THE BALLOON TO WING. NO MATERIAL OR MANUFACTURING DEFICIENCIES WERE NOTED.
RETURNED PRODUCT ANALYSIS CONFIRMED SLOW DEFLATION OF THE BALLOON, IN APPROXIMATELY 30 SECONDS. A KINK IN THE INFLATION LUMEN MAY HAVE PARTIALLY RESTRICTED THE FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED.
A PENCIL-TIP SIZE BURN WAS SUSTAINED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED.
DEVICE DISCARDED BY HOSPITAL. NO FURTHER INFORMATION WILL BE PROVIDED BY THE HOSPITAL. NO LOT NUMBER COULD BE LOCATED BY THE HOSPITAL. UNABLE TO INVESTIGATE FURTHER AT THIS TIME.
HAND CONTROLLED ELECTROSURGICAL PENCIL USED DURING L AXILLARY DISSECTION. PENCIL WOULD NOT WORK IN CUTTING MODE. BIOMED DOES NOT THINK THE PENCIL WAS TRIED PRIOR TO THE PROCEDURE. THE BIOMED DOES NOT THINK THIS EVENT COMPROMISED THE PROCEDURE. THERE WAS A SMALL DELAY. NO PT INJURY- NO PROBLEM.
INVESTIGATION OF THE ABOVE REFERENCED COMPLAINT HAS BEEN COMPLETED. THE ORIGINAL COMPLAINT STATING THAT "DURING L-AXILLARY DISSECTION, PENCIL WOULD NOT WORK IN CUTTING MODE." WAS RECEIVED 8/19/96 AND THE DEVICE WAS RECEIVED AT CO FOR EVAL ON 8/29/96. CO FILED A MALFUNCTION MDR ON THIS EVENT BASED ON THE INFO PROVIDED, NO INJURY OCCURRED AND THE HOSPITAL SUBMITTED A VOLUNTARY USER REPORT ON THIS INCIDENT. EVAL OF THE DEVICE WAS CONDUCTED AND THE PENCIL WAS TESTED FOR ACTIVATION FORCE PER AN IN HOUSE METHODOLOGY. THIS PENCIL WAS CONFIRMED AS FUNCTIONING PROPERLY IN BOTH MODES, AND HAVING THE LOW FORCE TO ACTIVATE THAT IS EXHIBITED IN CURRENT PRODUCTION DEVICES. THE DEVICE IN QUESTION MEASURED A CUT FORCE OF .66 LBS AND A COAG APPROX. 1.0 LBS FOR CURRENT PRODUCT. AS YOU REMEMBER FROM PREVIOUS CORRESPONDENCE, ON UNACCEPTABLE PRODUCT MANUFACTURED PRIOR TO THE 96E LOTS, THE AVERAGE FORCE TO ACTIVATE WAS AS HIGH AS 2.31 LBS IN CUT AND 2.36 LBS IN COAG, WITH A LOW OF 1.40 LBS FORCE. THE INCIDENT PENCIL HAD THE IDENTIFIED CHANGES TO THE PRODUCT PROCESS AND SWITCH CORE TOOLING WHICH HAVE BEEN IN PRODUCTION SINCE LOT CODE 96E AS PREVIOUSLY STATED. THESE DEVICES ARE CONSISTENT IN ACTIVATION FORCE AND SWITCH CONFIGURATION WITH PRODUCT MANUFACTURED AND ACCEPTED BY THE USER FOR THE PAST SEVERAL YEARS. MANUFACTURING AND ENGINEERING ARE CLOSELY MONITORING THE FORCES DURING PRODUCTION, REJECTING THE HIGHER FORCE DEVICES. ALTHOUGH WORK CONTINUES TO ESTABLISH A QUANTITATIVE VALUE FOR THE ACCEPTABLE CUSTOMER LEVELS, ALL INDICATIONS ARE DEVICE WAS ON THE LOWER END OF THIS ACCEPTANCE RANGE.
CLINICAL STUDY. DURING A LASER RESECTION OF THE PROSTATE, THE LASER LOST POWER, RESULTING IN THE PROCEDURE BEING PROLONGED AND EVENTUALLY TERMINATED PRIOR TO COMPLETION. PT THEN HAD A DISTENDED, PAINFUL ABDOMEN WHICH REQUIRED ADMINISTRATION OF MORPHINE AND DITROPAN FOR DISCOMFORT -- ALSO IV FLUIDS WERE ADMINISTERED.
H.3 MANUFACTURER HAS NOT YET RECEIVED ENOUGH INFORMATION FROM USER FACILITY TO MAKE AN EVALUATION. EVENT FREQUENCY. IS THE FREQUENCY OF OCCURRENCE OF EVENT ADDRESSED IN DEVICE LABELING? N. IF NO, THEN IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? U. EVENT SEVERITY. IS THE SEVERITY OF OCCURRENCE OF EVENT ADDRESSED IN DEVICE LABELING? N. IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL.
THE INSTRUMENT WAS USED DURING AN UNKNOWN PROCEDURE. THE RUBBER SEAL DISLODGED FROM THE TROCAR. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT'S INNER GASKET "DISLODGED" FROM THE TROCAR DURING SURGERY. THE INNER GASKET WAS DETACHED AND RECEIVED WITH THE INSTRUMENT. NO CONCLUSION COULD BE REACHED AS TO HOW THE GASKET HAD BECOME DETACHED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS. APPROPRIATE ENGINEERING AND MFG PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.
PLEDGET ADHERED TO SWAB PRIOR TO USE. WHILE COLLECTING A THROAT CULTURE, THE PLEDGET BECAME DETACHED FROM THE SWAB AND LODGED IN THE PT'S THROAT. THE MD REMOVED THE PLEDGET WITH HIS FINGER.
PLEDGET PULL-OUT WAS FOUND DURING ASSEMBLY OF PRODUCT. MATERIAL WAS RE-WORKED. 10 PIECES FROM RETENTION SAMPLES WERE EVALUATED FOR PLEDGET PULL-OUT. NONE WAS OBSERVED.
THE UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED, THE CAUSE OF WHICH WAS THE ROTARY VALVE. CO HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE TEC 6 VAPORIZER. AS A RESULT, THE FREQUENCY OF OCCURRENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED U.S. BASE IN FISCAL YEAR 1996 FROM 0.4% IN 1994. CO WILL CONTINUE TO MONITOR THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER MATERIAL AND/OR PROCESS MODIFICATIONS.
PRECISION TESTS PERFORMED BY DEVICE USER WERE CONFIRMED TO BE OUTSIDE OF MANUFACTURER'S RECOMMENDATION (PLUS OR MINUS 10%).  IMPRECISE READINGS UNDER CERTAIN CONDITIONS COULD HAVE ADVERSE CLINICAL EFFECTS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. PRIOR TO USING THE DEVICE ON THE PT, THE OBTURATOR WAS INSERTED INTO THE TROCAR SLEEVE JUST BEFORE INTENDED USE, THE SURGEON ASSISTANT REMOVED THE OBTURATOR AND NOTICED FTHE SEAL WAS NOT INTACT. THE SEAL WAS NOT INSPECTED PRIOR TO INITIAL OBTURATOR INSERTION, AND IT IS NOT CLEAR IF THE SEAL WAS TORN OR IMPROPERLY FORMED. ANOTHER DEVICE WAS OPENED FOR THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT'S OUTER GASKET HAD BECOME "TORN". THE INSTRUMENT WAS RECEIVED WITH A TORN OUTER GASKET. THE PIECE WHICH HAD TORN FREE, APPROXIMATELY 20% OF THE GASKET, WAS NOT RECEIVED WITH THE INSTRUMENT. INSTRUMENT DID NOT APPEAR TO HAVE BEEN USED SURGICALLY.THE ASSEMBLY LOCATION HAS BEEN INFORMED ABOUT THIS INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE ITS PRODUCTS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLESYSTECTOMY. THE CLIPS FROM THE DEVICE CAME OUT OF THE INSTRUMENT UNFORMED. THE FIRST CLIP REPORTEDLY WAS FINE, BUT THE SUBSEQUENT CLIPS WERE SPITTING OUT OF THE INSTRUMENT AND WOULD NOT FORM WHEN THE JAWS OF THE INSTRUMENT CLOSED. THE DEVICE WAS ONLY PLACED ACROSS THE CYSTIC DUCT. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. 08/21/96 1400 TWO CLIPS FELL INTO THE PT AND WERE RETRIEVED LAPAROSCOPICALLY.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
THE T-CONNECTOR DISCONNECTED FROM THE CATHETER RESULTING IN THE LOSS OF BLOOD. THE PT REQUIRED BLOOD TRANSFURSION.
CUSTOMER INDICATED SAMPLES WOULD NOT BE RETURNED TO CO FOR EVALUATION. LOT HISTORY REVIEW WAS NOT AVAILABLE AS THE LOT NUMBER WAS UNK TO THE CUSTOMER. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVALUATION. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THS MDR CLOSED WITH THIS REPORT.
THE THERAPIST NOTICED THE DISPLAYED EXHALED TIDAL VOLUME WAS HIGHER THEN THE SET TIDAL VOLUME BY 800CC.
THE UNIT WAS INSPECTED AND EVALUATED FOR 10 DAY CHECKING ALL LEVELS OF DELIVERED AND EXHALED VOLUMES, UNIT PLACED IN THE ENVIRONMENTAL CHAMBER AT 101 F. TO STRESS THE COMPONENTS, IT OPERATED TO ALL MFRS SPECS. THE PROXIMAL PRESSURE GUAGE WAS FOUND BROKEN. THE MOSTLY CAUSE OF THE EVENTS AS DESCRIBED BY THE HOSPITAL IS BELIEVED TO HAVE BEEN RELATED TO THE FINDINGS BY THE MFR'S FIELD SERVICE REP. ON 10/16/96 HAVING FOUND A BAD FLOW TRANDUCER, PT OUTLET PORT LEAKING, AND A HOLE IN THE EXHALATION VALVE BALLOON.
PRECISION TESTS PERFORMED BY DEVICE USER WERE CONFIRMED TO BE OUTSIDE OF MANUFACTURER'S RECOMMENDATIONS (PLUS OR MINUS 10%).  IMPRECISE READINGS UNDER CERTAIN CONDITIONS, COULD HAVE ADVERSE CLINICAL EFFECTS.
ALLEGES FIBROMYALGIA, CHRONIC FATIGUE SYNDROME, RHEUMATOID ARTHRITIS SYNDROME, MS SYNDROME, CHRONIC PROGRESSIVE PERIPHERAL NEUROPATHY.
RT RESPONDED TO A CALL FOR AN EMERGENCY TO A PT'S ROOM. UPON ENTERING, THE RT STATED HEARING A "WHOOSHING" SOUND FROM THE VENTILATOR SYSTEM. THE RT IMMEDIATELY REMOVED THE PT FROM THE SYSTEM AND MANUALLY VENTILATED. THE PT WAS LATER MOVED TO THE ICU AND WAS SAID TO HAVE EXPIRED. THE REPORTER STATED THE RT RETURNED TO THE ROOM TO TROUBLE SHOOT THE CIRCUIT BUT IT WAS GONE. THE EVENT REPORTER INDICATED THEY DID NOT ATTRIBUTE THE PT'S DEATH TO THE CIRCUIT. THERE WAS NO INTERNAL REPORT NOR MEDWATCH GENERATED FROM THIS FACILITY. THE REPORTER INDICATED THAT DURING A ROUTINE CIRCUIT CHANGE ONE OF HER STAFF FOUND AN EXHALATION VALVE " APART" AND IMMEDIATELY CHANGED TO ANOTHER CIRCUIT WITHOUT INCIDENT. FOR THIS REASON SHE FELT SHE SHOULD REPORT THE ABOVE EVENT TO THE MFR.
INVESTIGATION COULD NOT BE PERFORMED ON THE ACTUAL EVENT CIRCUITS AS NOT RETAINED BY REPORTER. ADD'L SAMPLES OF THE SAME LOT WILL BE EVALUATED AND A FOLLOW UP REPORT SUBMITTED.
THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. THE DR COULD NOT CUT THROUGH THE TISSUE COMPLETELY BY USING DEVICE. STAPLES BECAME MALFORMED.DR FINISHED THE CASE WITH ANOTHER DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT CUT" DURING SURGERY. THE INSTRUMENTS WERE RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENTS WERE CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENTS WERE DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENTS WERE FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP SINCE THE SILICON RING OF FLAPPER BULB DETACHED, GAS LEAKED. THERE WAS NO CONSEQUENCE TO THE PT.
DEVICE RETURNED WITH NO LOT IDENTIFICATION. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT'S INNER GASKET HAD BECOME "DETACHED" AND WAS NOT RECEIVED WITH THE INSTRUMENT. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS. THE ASSEMBLY LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
MORBIDLY OBESE PT UNDERWENT COLONOSCOPY DURING WHICH SHE BEGAN TO MAKE "BRISK" MOVEMENTS DESPITE INSTRUCTION TO THE CONTRARY. UPON WITHDRAWING THE SCOPE THE PHYSICIAN BELIEVED HE NOTED A PERFORATION. AN EXPLORATORY LAPAROTOMY REVEALED A PERFORATED SIGMOID COLON.
NO AUDIBLE ALARM. F BLOCK: NOT USER FACILITY REPORTED.
FINAL ANALYSIS CONFIRMED NO AUDIBLE ON ERROR OR ALARMS. DISCLAIMER: THIS REPORT MAY BE REQUIRED BY MEDICAL DEVICE REPORTING REGULATIONS CONTAINED IN 21 CFR SECTION 803. THESE REGULATION ARE VAGUE IN A NUMBER OF RESPECTS AND SUBJECT TO DIFFERENT INTERPRETATIONS. MOREOVER, THE REGULATIONS REQUIRE CO TO MAKE A DECISION ON REPORTING BEFORE HAVING COMPLETE INFO, INCLUDING ITS OWN ANALYSIS OF RETURNED PRODUCT. THUS, CO'S DECISION TO FILE THIS REPORT SHOULD NOT BE LOOKED UPON AS ANYTHING OTHER THAN CO'S TRANSMITTAL OF UNCONFIRMED FIELD INFO WHICH THE FOOD AND DRUG ADMINISTRATION HAS REQUIRED MANUFACTURERS TO SUBMIT. CO BELIEVES THAT DISCLOSURE OF THE INFO REGARDING DEVICE EVALUATION COULD SUBSTANTIALLY HARM CO'S COMPETITIVE POSTION. CO SUBMITS THE INFO IN CONFIDENCE EXPECTING THAT THE FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF THE FREEDOM OF INFORMATION ACT. CO BELIEVES THAT ANY DISCLOSURE OF THE INFO BY A FEDERAL EMPLOYEE COULD CONSTITUTE A VIOLATION OF THE CRIMINAL LAW (18 U.S.C. SECTION 1905.
DUE TO THE SEALED ENDS OF THE ABDOMINAL DRESSING THERE IS NO VISIBILITY OF HEMORRHAGING FROM THE INCISION SITE. PT WAS HEMORRHAGING, WHICH WENT UN-NOTICED AS THERE WAS NO BLOOD LEAKAGE AROUND THE BANDAGE. PT WAS ADMITTED TO ICU. STAFF FEELS THE DRESSING CONTRIBUTED TO LATE DETECTION OF THE BLEEDING. REPORTER HAS ALSO REPORTED RED RASH ON REMOVAL OF DRESSING.
THE ABDOMINAL DRESSING IS A COMPONENT OF THE SMA30CSMHE KIT. ABDOMINAL DRESSING NUMBER: 7195. LOT NUMBER: UNK. MFR BY: ANOTHER CO. THE MFR HAS BEEN NOTIFIED OF THIS ISSUE AND CO IS AWAITING ITS INVESTIGATION.
ALLEGATIONS OF SYMPTOMS INCLUDING BUT NOT LIMITED TO RASH, FEVER, CHILLS, NIGHT SWEATS, JOINT PAIN, DRY EYES, DRY THROAT, DRY SKIN, PAINFUL ARMPITS, CHRONIC FATIGUE, MEMORY LOSES, HAIR LOSS, CARPAL TUNNEL SYNDROME, CHEST PAIN, FREQUENT COLDS, FLU LIKE SYMPTOMS, FREQUENT SORE THROATS, DIZZINESS, LOW WHITE BLOOD CELL COUNT, PAIN OR HARDENING IN THE BREAST, SHORTNESS OF BREATH, KIDNEY PROBLEMS, ARTHRITIS LIKE PAINS, SPASTIC COLON, LOSS OF SENSATION OF BREAST TISSUE, RUNNY NOSE, MUSCLE ACHES AND PAINS, NIPPLE LEAKAGE, PIMPLES OVER BODY FILLED WITH CLEAR FLUID AND HEADACHES.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THE CLIPS WERE MALFORMED. THE SURGEON USED NEW INSTRUMENT IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
EVALUATION SUMMARY INADVERTANTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED EMPTY AND LOCKED OUT. NO TESTING COULD BE PERFORMED AS THE INSTRUMENT WAS RETURNED EMPTY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
CIRCUMCISION CLAMP WAS PLACED ON FORESKIN, THE FORESKIN SLIPPED OUT OF THE CLAMP BEFORE HEMOSTASIS HAD OCCURRED IN THE FORESKIN. ALL CLAMPED AREAS WERE IN PROPER POSITION. MULTIPLE 4.0 CHROMIC SUTURES WERE PLACED IN THE FORESKIN AND FORESKIN WAS RE-INSPECTED. GAUZE RE-WRAPPED NO BLEEDING (AS DESCRIBED BY THE PHYSICIAN).
THE REPORTER STATES A 3.5X8 CM HEMATOMA ON LEFT UPPER AREA APPEARED IMMEDIATELY ON REMOVING DRAPE. REPORTER CONSIDERS THIS TO BE A SERIOUS INJURY CAUSED BY POOR TECHNIQUE IN REMOVING THE DRAPE. NO MEDICAL TREATMENT WAS GIVEN FOR THIS CONDITION.
CAPSULAR CONTRACTURE AFTER BILATERAL SUBMUSCULAR BREAST REPLACEMENT FOR DEFLATION OF L SALINE FILLED IMPLANT. S/P BILAT BREAST AUGMENTATION WITH SALINE FILLED IMPLANTS 1985.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS A TEST RESULT OUT-OF-RANGE OF THE QUALITY CONTROL SOLUTION LOW RANGE (QUALITY CONTROL SOLUTIONS ARE SPECIFICALLY INTENDED TO VERIFY DEVICE PERFORMANCE).  ANALYSIS INDICATES THAT THIS RESULT, HAD IT BEEN OBTAINED FROM A PATIENT SAMPLE, COULD POTENTIALLY HAVE HAD AN ADVERSE CLINICAL EFFECT.
THE DEVICE WAS USED DURING A HERNIA REPAIR. IT WAS REPORTED BY THE REP IT WAS JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
H6; INSTRUMENT REC'D WITH A FORMED STAPLE JAMMED IN THE NOSE AND 2 UNFORMED STAPLES FIRED OVER IT. NOSE WELD BROKEN, CRIMP HAD YIELDED.
OUTSIDE PACAKGE LABELED AS A RIGHT COMPONENT; INSIDE PACKAGE AND COMPONENT LABELED AS A LEFT COMPONENT. SURGICAL TIME INCREASED BY GREATER THAN 1 HR. WHILE LOCATING APPROPRIATE COMPONENT FOR IMPLANTATION. PT TOLERATED ADD'L ANESTHESIA TIME WITHOUT ANY REPORTED INJURY.
PACKAGING MATERIALS AND DEVICE SENT TO MFR FOR REVIEW AND ANALYSIS. IT IS LIKELY THAT BASED ON THE LOT NUMBERS AND REVIEW OF MANUFACTURING RECORDS THAT THE PRODUCT WAS INCORRECTLY RE-BOXED AFTER LEAVING CO THEREBY CAUSING THE PROBLEM ALTHOUGH THIS COULD NOT BE CONFIRMED. NOTE: THE INFO IN SECTION F IS BEING SUPPLIED BY THE MFR, NOT THE USER FACILITY. NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY.
AFTER IABP FOR FOR ABOUT 12 HOURS, THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PTACH, WHEN STAINED, EXHIBITED THE TUPICAL APPEARANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURINF IABP. DEVICE LEBELLING CODE: 1738.
PT RECEIVED 16 CC BOLUS OF PROPOFOL DRIP ON INFUSION PUMP WHEN STAFF SET MG/HR RATHER THAN CC/HR. REQUIRED INTERVENTION. RECOVERED TO BASELINE.
A HYSTERESIS RATE OF 50 WAS PROGRAMMED ON WITH THREE SEARCH CYCLES. FOLLOWING PROGRAMMING OF NEW PARAMETERS, AN ITP WAS PERFORMED, WHICH INDICATED SEARCH CYCLES WERE OFF. THE RATE/TIMING SCREEN FOLLOWING ANOTHER INQUIRE INDICATED SEARCH CYCLES OF THREE WERE STILL ON. MODE WAS DDD+ HYSTERESIS.
THE PROGRAMMER DOES NOT UPDATE THE DISPLAYED HYSTERESIS VALUE. IF THE USER ATTEMPTS TO PROGRAM THE DEVICE AGAIN DURING THE TWO FAST BEATS (THIS WOULD ONLY OCCUR BY MISTAKE), THE DURATION OF THE FAST BEATS WILL BE EXTENDED UNTIL THE END OF THE NEW PROGRAMMING OPERATION.
MONITORING PT WITH A BLOOD GLUCOSE METER REFLECTED A READING OF LOW BLOOD SUGAR AFTER SEVERAL CHECKS WITH CONTINUED LOW READINGS REQUIRING MEDICAL INTERVENTION WITH IV SOLUTION, WITH NO SIGNIFICANT CHANGE IN GLUCOSE METER READING, PT REPORTED AS "CONTINUED HYPOGLYCEMIA FOLLOWED BY SEIZURE." BLOOD WAS DRAWN FOR TESTING AND RESULTS READ "78" WHEREAS GLUCOSE METER READ "34". PT GIVEN ONE AMP OF D50W AND FOOD WITH FURTHER MONITORING.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT REMOVAL. THE PT WAS RELEASED AND LATER RETURNED TO THE EMERGENCY ROOM AND WAS DIALYZED.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT LOSS REPORTED. THE PT WAS RELEASED FROM THE FACILITY, BUT WAS LATER ADMITTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH REPORTED. THE PT WAS DIALYZED IN THE EMERGENCY ROOM AND IS CURRENTLY REPORTED TO BE OKAY. A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. THE PT HAS HAD A HISTORY OF RESPIRATORY PROBLEMS AND WAS UNDER OBSERVATION AND TREATMENT FOR THOSE PROBLEMS PRIOR TO THE FAILURE IN THIS INVESTIGATION. THE PT IS CURRENTLY REPORTED TO BE DOING FINE. CO NUMBER OF RETURNED COMPONENT/ASSEMBLY (WHEN APPLICABLE): NA. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT THERE WAS ONE OTHER INCIDENT (CPF 1096159C3) CAUSED BY FAILURE INVESTIGATED IN THIS REPORT. THIS SECOND COMPLAINT WAS FOR A SECOND PT WHICH WAS AFFECTED BY THE SAME FUSE FAILURE. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/21/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED 00.1 OHMS, INDICATING THAT THE FUSE COULD STILL BE GOOD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS. WHEN THE PUMP COOLS DOWN, THE FUSE BECOMES OPERATIONAL AGAIN. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. FOLLOWUP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. FAILURES CODES: F CODE UFPMP004WR. CUSTOMER CONTACTED: YES. SALES/SERVICE CONTACTED BY INVESTIGATOR: NO. TRAINING REQUIRED? NO.
UNDERWENT DIAGNOSTIC CARDIAC CATH. ALL FINDINGS WITHIN NORMAL LIMITS. LAST INJECTION WAS OF AORTIC ROOT USING AN ANGIO INJECTION SYSTEM POWER INJECTOR. 40 CC'S OF AIR WERE INJECTED INTO THE PT. THE PT WAS TREATED IN A HYPERBARIC CHAMBER AND RECOVERED. AT THE TIME OF THE INITIAL INVESTIGATION, THE CAUSE WAS ATTRIBUTED TO HUMAN ERROR RATHER THAN DEVICE MALFUNCTION. THE DEVICE WAS EXAMINED BY IN HOUSE BIO MED STAFF AND FOUND TO BE FUNCTIONING PROPERLY. DURING SUBSEQUENT STAFF INTERVIEWS, THE INJECTOR WAS INTENTIONALLY FILLED WITH AIR AND THE DIGITAL READOUT DISPLAYED "NO AIR", WHICH WAS AN EVENT THAT WAS NOT PREVIOUSLY NOTED BY THE OPERATORS OF THE DEVICE.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS A TEST RESULT OUT-OF-RANGE OF THE QUALITY SOLUTION LOW RANGE (QUALITY CONTROL SOLUTIONS ARE SPECIALLY INTENDED TO VERIFY DEVICE PERFORMANCE).  ANALYSIS INDICATES THAT THIS RESLULT, HAD IT BEEN OBTAINED FROM A PATIENT SAMPLE, COULD POTENTIALLY HAVE HAD AN ADVERSE CLINICAL EFFECT.
PHYSICIAN REMOVED DRAIN AND RIGHT DRAIN BROKE OFF IN PT. PT REQUIRED ARTHROTOMY ON 1/31/96 TO REMOVE RETAINED FOREIGN BODY. 6" OF PLASTIC DRAIN REMOVED.
THE PT PRESENTED TO THE ER WITH VAGINAL BLEEDING S/P MISCARRIAGE. A PELVIC ULTRASOUND WAS ORDERED. IN PREPARATION FOR THE PROCEDURE A FOLEY CATHETER WAS PLACED. DURING THE PROCEDURE THE PT FELT SOMETHING "POP" IN HER BLADDER. THE FOLEY CATHETER FELL OUT AND IT WAS NOTED THAT THE BALLOON HAD COMPLETELY RUPTURED WITH PIECES OF THE BALLOON RETAINED IN THE PT'S BLADDER. THE PT WAS TAKEN TO SURGERY FOR REMOVAL OF THE BROKEN BALLOON.
GUIDE WIRE WAS ADVANCED ACROSS THE STENOSIS IN THE LAD ARTERY AND WENT INTO THE SEPTAL. THE WIRE THEN SEEMED TO GET STUCK IN THE SEPTAL, AND AS IT WAS PULLED BACK TO ADVANCE INTO THE MAIN LAD ARTERY, THE DISTAL TIP (APPROX 5MM) BROKE OFF AND REMAINED IN THE SEPTAL.
NEEDLE BROKE IN THE BONE. SURGICAL EXTRACTION ATTEMPTED FAILED.
LOT HISTORY WAS REVIEWED, THERE ARE NO ABNORMALITIES NOTED IN EITHER PRODUCTION OR QUALITY ASSURANCE RECORDS. IN SIMILAR INSTANCES IN WHICH SAMPLES WERE AVAILABLE FOR EVALUATION THE FOLLOWING INFO HAS BEEN OBTAINED. IT IS EXTREMELY IMPORTANT THAT THE TROCAR REMAINS IN PLACE WHILE ENTERING THE BONE AS IT SUPPORTS THE CANNULA AND PREVENTS COLLAPSE. WHEN EXCESSIVE LATERAL FORCES ARE PLACED ON A CANNULA WITHOUT THE PRESENCE OF THE TROCAR, THE CANNULA CAN BEND. THE CANNULA WILL EXHIBIT A "WALL ABERRATION" DUE TO THE HOLLOW INTERNAL PORTION OF THE CANNULA. THIS ABERRATION IS SIMILAR TO A GLASS THAT HAS BEEN "SCORED". IF THE CANNULA IS RE-STRAIGHTENED THE CANNULA CAN BREAK.
THE IAB WAS INSERTED INTO THE PT AT 12:00 NOON. IN THE EVENING, THE "HELIUM GAS LEAK" ALARM SOUNDED FROM THE SYSTEM 97 PUMP AND THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH F WAS ASLO THE MFR. NO MEDWACH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. NO DEFECT WAS FOUND IN THE RETURNED IAB. INSPECTION OF THE BALLOON DISCLOSED NO DEFECTS. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE DEVICE. DEVICE LABELLING CODE IS 1738.
ALLEGATIONS OF SYMPTOMS INCLUDING BUT NOT LIMITED TO RASH, FEVER, CHILLS, NIGHT SWEATS, JOINT PAIN, DRY EYES, DRY THROAT, DRY SKIN, PAINFUL ARMPITS, CHRONIC FATIGUE, MEMORY LOSS, HAIR LOSS, CARPAL TUNNEL SYNDROME, CHEST PAIN, FREQUENT COLDS, FLU LIKE SYMPTOMS, FREQUENT SORE THROATS, DIZZINESS, LOW WHITE BLOOD CELL COUNT, PAIN OR HARDENING ON THE BREAST, SHORTNESS OF BREATH, KIDNEY PROBLEMS, ARTHRITIS LIKE PAINS, SPASTIC COLON, LOSS OF SENSATION OF BREAST TISSUE, RUNNY NOSE, MUSCLE ACHES AND PAINS, NIPPLE LEAKAGE, PIMPLES OVER BODY FILLED WITH CLEAR FLUID AND HEADACHES.
DEVICE LABEL CODE FOR F10. POSITION 1: 1701 AND POSITION 2: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 8/26/96. PATIENT'S CURRENT STATUS: WELL - RPT'D 8/26/96.
CRACK IN THE JAW OF THE CLAMP OCCURRED WHILE THE CLAMP WAS CROSS-CLAMPED ON THE PT'S AORTA.
OBSERVED INSTRUMENT TO BE CRACKED AT THE BOXLOCK. LOT CODE INDICATES THAT THE CLAMP WAS MANUFACTURED IN 1988. SINCE THAT TIME AN ENGINEERING CHANGE WAS APPROVED AND IMPLEMENTED TO MAKE IMPROVEMENTS TO THE FUNCTIONALLY AND DURABILITY OF THE CLAMP WHICH HAS MINIMIZED THIS TYPE OF COMPLAINT.
DURING THE DIALYSIS PROCEDURE THE TUBING ON THE ARTERIAL SIDE BECAME DISCONNECTED AT THE LUER LOCK. AIR WAS OBSERVED IN THE TUBING. BOTH THE ARTERIAL AND VENOUS LINE WERE CLAMPED IMMEDIATELY. THE "AIR DETECTOR" HAD NOT ALARMED PRIOR TO CLAMPING. THE PT EXPERIENCED A CARDIOPULMONARY ARREST. CHEST X-RAY REVEALED AIR EMBOLUS. THE PT EXPIRED FOLLOWING UNSUCCESSFUL RESUSCITATION. UPON EXAMINATION, THE APPARENT CAUSE OF DISCONNECT WAS THAT THE LUER-LOC FITTING WAS NOT TIGHTLY SECURED. THIS WAS DISCUSSED WITH THE DIALYSIS PERSONNEL AND IT WAS CONCLUDED THAT IN THE FUTURE THESE WOULD BE CAREFULLY CHECKED. WHENEVER THE PTS ARE TURNED, THE DIALYSIS PERSONNEL WILL HOLD THE CONNECTIONS TO INSURE THAT THERE IS NO POSSIBILITY OF A DISCONNECT. THE POLICY WAS ALSO CHANGED IN THAT THE AREA WILL BE SECURED WITH TAPE AS WELL.
ALLEGATIONS OF SYMPTOMS INCLUDING BUT NOT LIMITED TO RASH, FEVER, CHILLS, NIGHT SWEATS, JOINT PAIN, DRY EYES, DRY THROAT, DRY SKIN, PAINFUL ARMPITS, CHRONIC FATIGUE, MEMORY LOSS, HAIR LOSS, CARPAL TUNNEL SYNDROME, CHEST PAIN, FREQUENT COLDS, FLU LIKE SUMPTOMS, FREQUENT SORE THROATS, DIZZINESS, LOW WHITE BLOOD CELL COUNT, PAIN OR HARDENING IN THE BREAST, SHORTNESS OF BREATH, KIDNEY PROBLEMS, ARTHRITIS LIKE PAINS, SPASTIC COLON, LOSS OF SENSATION OF BREAST TISSUE, RUNNY NOSE, MUSCLE ACHES AND PAINS, NIPPLE LEAKAGE, PIMPLES OVER BODY FILLED WITH CLEAR FLUID AND HEADACHES.
FRAGMENT OF ANGIO CANNULA BROKE OFF IN PT'S LEFT ARM AT IV SITE.
PT UNDERWENT CATARACT SURGERY ON 8/6/96, AND IMPLANTATION OF INTRAOCULR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, DURING INSERTION THE PT MOVED AND THE POSTERIOR CAPSULE TORE. A VITRECTOMY WAS NECESSARY. THE LENS EJECTED IN A CONTROLLLED MANNER AND NO OTHER SURGICAL PROCEDURE WAS DONE.
H6 -RESULTS: THE PT MOVED DURING SURGERY CAUSED THE TEAR IN THE POSTERIOR CAPSULE. THERE WERE NO DEFECTS PRESENT ON THE RETURNED LENS. THE PT'S VISUAL ACUITY WAS 10/70 UNCORRECTED AND INTRAOCULAR PRESSURE WAS 18MM HG AT THE LAST POSTOP EXAM DATE OF 9/30/96. THE SURGEON STATED THAT THE PROGNOSIS OF THIS PT IS GOOD AND IMPROVING. LENS BOX WAS RECEIVED. THE BOX CONTAINED 7 CHART LABELS, THE PT ID CARD, PT REGISTRATION CARD, CARTRIDGE TRAY AND LENS TRAY TAPED TOGETHER. THE LENS WAS CONTAINED IN BETWEEN THE TRAYS. THE LENS WAS REMOVED FROM THE TRAY AND INSPECTED FOR GENERAL DEFECTS. THE LENS HAS DRIED BSS/VISCOELASTIC-TYPE RESIDUE. THE HAPTICS POSSESS THE PROPER CURVATURE AND ANGULATION. THE LENS WAS INSPECTED ACCORDING TO COSMETIC SPECIFICATIONS, AFTER WHICH NO DEFECTS WERE NOTICED. THE LENS WAS REPLACED DUE TO A TORN CAPSULE AND VITRECTOMY.
PT HAVING EXCISION OF RIGHT BREAST MASS. PT HAD PRIOR INSERTION OF SILICONE IMPLANT IN 1982. PT HAD COMPLAINED RIGHT ARM PAIN AND PHYSICIAN NOTICED LUMP IN RIGHT LATERAL BREAST. EXCISION OF MASS PERFORMED AND SPECIMEN SENT FOR FROZEN SECTION. RESULT: REPORT OF COLLAGEN AND FAT WITH FOREIGN BODY MATERIAL AND FOREIGN BODY GIANT CELL REACTION; BENIGN. RIGHT BREAST IMPLANT WAS FOUND RUPTURED. BILATERAL IMPLANTS REMOVED AND SALINE BREAST IMPLANTS RE-IMPLANTED.
DURING AN ATTEMPTED IMPLANT, THE PT WAS INDUCED INTO VF. THE ICD DETECTED THE ARRHYTHMIA, DISCHAGED AND CONVERTED THE PT. AFTER THE DISCHARGE, NO COMM WITH THE ICD COULD BE ESTABLISHED.
H.3 EVALUATION SUMMARYTHE DEVICE DID HAVE COMMUNICATIONS DIFFICULTIES WHEN IT WAS RECEIVED.  IT IS THOUGHT THAT THE COMMUNICATION DIFFICULTIES WERE CAUSED BY LOW BATTERY VOLTAGE.  ONCE THE DEVICE SUBASSEMBLY (SFA) WAS POWERED UP USING A POWER SOURCE OF VOLTAGE IN THE NORMAL OPERATING RANGE OF A BATTERY, THE DEVICE FUNCTIONED PROPERLY.  IT IS BELIEVED THAT THE DEVICE LATCHED-UP ELECTRICALLY CAUSING COMMUNICATION DIFFICULTIES AND A HIGHER THAN NORMAL LDD CURRENT, WHICH DEPLETED THE BATTERY.  THE CAUSE OF THE LATCH-UP WAS NOT DETERMINED.  ONCE THE DEVICE WAS RE-POWERED IT HAD NORMAL FUNCTIONALITY.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP IMPOSSIBLE TO OPEN THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B3,6,7: D10: INFO NOT PROVIDED BY AFFILIATE. D5,6; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP MOST OF THE STAPLES WERE MALFORMED. (ONLY 20 STAPLES OUT OF 2XOMS20 AND 2XOMR20). THE CASE WAS FINISHED WITHOUT DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: AB)BASED ON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, NO CONCLUSION COULD BE REACHED AS TO WHY THE INST'S. "STAPLES WERE MALFORMED". THE INSTS. WERE RECEIVED WITH EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLIES. A)THE INST. WAS CYLCED AND FIRED THE FIRST STAPLE WITHOUT INCIDENT. THE SECOND STAPLE FIED, TWISTED AND JAMMED IN THE NOSE. THE STAPLE WAS REMOVED AND THE REMAINING 12 STAPLES FIRED WITHOUT INCIDENT. THE SECOND STAPLE FIED, TWISTED AND JAMMED IN THE NOSE. THE STAPLE WAS REMOVED AND THE REMAINING 12 STAPLES FIRED WITHOUT INCIDENT. B)THE INST. WAS CYLCED AND FIRED 1 STAPLE WITHOUT INCIDENT AND ON THE SECOND FIRING A DOUBLE FEED OCCURRED CAUSING A JAM. THE DOUBLE FED STAPLES WERE REMOVED AND THE INST. FIRED THE REMAINING 6 STAPLES WIHTOUT INCIDENT. AB)THE STAPLES WERE PROPERLY FORMED AND WERE WITHIN DESIGN SPECIFICATIONS. IT WAS CONCLUDED THAT THE TWISTING OF THE STAPLES (INST. "A") AND THE DOUBLE FEEDING OF THE STAPLES (INST. "B") WAS DUE TO THE EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLIES. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT THE STAPLES FEED, FIRE AND FORM CORRECTLY.
CUSTOMER REPORTS, 8-10 INSTANCES OF THE DEVICE JAMMING AND NOT UNSEATING THE NEEDLE. ON 8/1/96 AN EMPLOYEE SUSTAINED A NEEDLESTICK. THE NEEDLE DISENGAGED AND WHEN THE HOLDER WAS PULLED BACK, THE NEEDLE CAME BACK OUT AND STUCK THE EMPLOYEE IN THE BACK OF THE FINGER. THE EMPLOYEE RECEIVED NEEDLESTICK TREATMENT AND IS IN FINE CONDITION.
ACTUAL USED UNIT WAS NOT RETURNED. UNUSED SAMPLES WERE RETURNED AND EVALUATED. UNITS ALL FUNCTIONED APPROPRIATELY WHEN USED PER LABELING INSTRUCTIONS. CONTACTED ONE PHLEBOTOMIST AT SITE, WHO REPORTED SHE USED THE PRODUCT INCORRECTLY (TWISTED CLOCKWISE). ADDITIONAL PRODUCT USE FOLLOW-UP REVEALED OTHER PHLEBOTOMISTS WERE USING PRODUCT INCORRECTLY ALSO. CUSTOMER HAS BEEN ADVISED OF CORRECT METHOD OF USE FOR THE DEVICE AND HAS STATED PHLEBOTOMISTS WILL BE RETRAINED IN THE PROPER USE OF THE DEVICE. EVAL REVEALED USER ERROR RESULTED IN DEVICE MALFUNCTION. THAT THIS REPORT MAY BE BASED UPON INO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE LENS WAS REPLACED DUE TO ACUTE CORNEAL DECOMPENSATION AND CORNEAL TOUCH. A VITRECTOMY WAS PERFORMED AND A PC IOL WAS SUTURED IN THE EYE. THE PHYSICIAN FELT THIS TO BE PRODUCT RELATED.
A4; ACCOUUNT UNABLE TO PROVIDE INFO. 2203 = VITRECTOMY. H6: METHOD 86 = PRODUCT NOT RETURNED FOR EVALUATION.
THE INSTRUMENT WAS USED DURING A BOWEL RESECTION. IT WAS REPORTED WHEN USING THE STAPLER, A BLUE PLASTIC PIECE ON THE RELOAD POPPED OFF AND FELL INTO PT 3 TIMES WITH 3 DIFFERENT INSTRUMENTS. THE PIECES WERE RECOVERED WITHOUT PT COMPROMISE. THESE EVENTS OCCURRED BOTH ON INITIAL FIRING AND RELOADS. THERE WAS NO CONSEQUENCE TO THE PT. THE USED INSTRUMENTS WERE ALL DISCARDED. REP RETURNING 1 STERILE INSTRUMENT AND 1 STERILE RELOAD WITH SAME LOT NUMBERS OF THOSE USED.
EVALUATION SUMMARY INADVERTANTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENTS "BLUE PLASTIC PIECE ON THE RELOAD POPPED OFF AND FELL INTO PATIENT 3 TIMES WITH 3 DIFFERENT INSTRUMENT" DURING SURGERY. THE CARTRIDGE WAS RECEIVED IN A STERILE TYVEK POUCH AND NO DEFORMATIONS OR ANOMALIES WERE OBSERVED ON OR ABOUT THE CARTRIDGE, WHICH WOULD INDICATE THAT THE CARTRIDGE MAY HAVE BEEN MISPOSITIONED WHEN INSERTED. THE CARTRIDGE WAS INSERTED ONTO AN INSTRUMENT AND WAS CYCLED AND FIRED WITHOUT INCIDENT. THE STAPLES WERE FOUND TO BE WITHIN SPECIFICATIONS. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY.
OBSERVED INSTRUMENT TO BE CRACKED AT THE BOXLOCK. LOT CODE INDICATES THAT THE CLAMP WAS MANUFACTURED IN 1990. SINCE THAT TIME AN ENGINEERING CHANGE WAS APPROVED AND IMPLEMENTED TO MAKE IMPROVEMENTS TO THE FUNCTIONALLY AND DURABILITY OF THE CLAMP WHICH HAS MINIMIZED THIS TYPE OF COMPLAINT.
LENS REPLACEMENT DUE TO DISLOCATED IOL. A VITRECTOMY WAS PERFORMED. THE PHYSICIAN FELT THIS TO BE PRODUCT RELATED.
ACCOUNT UNABLE TO PROVIDE INFO. 2203 = VITRECTOMY. H6; METHOD 86 = PRODUCT NOT RETURNED FOR EVALUATION. PAT CODE: 2200=DISLOCATED INTRAOCULAR LENS, LABELED. 2203=VITRECTOMY, LABELED.
THE PT HAD HER DENTURES LINED WITH PRODUCT FOR THE FIRST TIME ON AUGUST 4,1991. THE DAY AFTER SHE DEVELOPED A BLISTER AND WAS TOLD BY HER DR THAT THERE WAS NOTHING WRONG. SHE HAD THE SECOND LINING DONE ON AUGUST 31 BECAUSE SHE WANTED A NEW TOP PLATE AND A PARTIAL BOTTOM PLATE AND HER DENTIST SAID HE NEEDED TO HAVE A GOOD FIT. SHE HAD IT DONE, LEFT TOWN AND THE NEXT DAY EXPERIENCED PAIN AND A SWOLLEN MOUTH. SHE SAW HER DENTIST ON AN EMERGENCY BASIS ON 9/3 WHO TOLD HER SHE HAD PAGENT'S DISEASE AND RECOMMENDED SHE SEE HER DR. HER DR SENT HER TO A NEUROLOGIST WHO WROTE IN A LETTER TO HER ORIGINAL DR AND I QUOTE:" IT SOUNDS TO ME LIKE THIS LADY HAD SOME FORM OF CHEMICAL REACTION TO THE ACRYLIC USED IN FITTING HER DENTURES AND AS A RESULT SUSTAINED SIGNIFICANT TISSUE INJURY. THERE IS NO QUESTION SHE MAY HAVE INJURY TO THE NERVE ENDINGS." SHE WENT TO A DENTIST IN THE U.S. ON HER OWN BECAUSE SHE STILL HAD A LOT OF PAIN AND WAS TOLD SHE HAD A REACTION TO THE CHEMICALS IN THE PRODUCT. HER GUMS ARE SEVERELY DAMAGED.
NO MANDATORY REPORT-INVOLVED. VOLUNTARY REPORT.
THE GENERATOR PLACED IN THE PATIENT WAS FOUND TO BE DEFECTIVE. THE REP TOOK THE GENERATOR WITH HIM.
A REPORT WAS RECEIVED FROM CO'S DIST. PHYSICIAN INSERTED THE CATHETER INTO A GUIDE CATHETER AND EXPERIENCED SOME RESISTANCE BUT WAS ABLE TO PASS THE CATHETER. HE ADVANCED THE CATHETER WITH A GUIDEWIRE AND WHEN HE EXCHANGED THE GUIDEWIRE WITH ANOTHER IT JAMMED. HE RETRIEVED THE SYSTEM AND FOUND THE DISTAL MARKER WAS MISSING. THE PT DID NOT SUFFER ANY ADVERSE EFFECT FROM THE REMAINING TIP. THE DEVICE WAS RETURNED BUT HAS BEEN HELD UP IN CUSTOMS AND REPORTEDLY THE FDA HAS DETAINED THE DEVICE.
ACCORDING TO THE DEVICE INFO SHEET, CATHETER WAS USED WITH A GUIDEWIRE, AND CONTINUOUS FLUSH WAS NOT USED INSIDE THE MICROCATHETER. DURING THE ANAYSIS, IT WAS CONFIRMED THAT THE DISTAL SHAFT WAS COMPLETE, HOWEVER THERE WAS A VISIBLE NECKING AND A HOLE ON THE SEGMENT OF THE MARKER COVERING, AND THE PLATINUM MARKER COIL WAS MISSING. IT SHOULD BE NOTED THAT DUE TO THE WAY THE CATHETER IS ASSEMBLED, THE IMPRESSION OF THE COIL IS STILL VISIBLE ON THE SHAFT. FROM THE CONDITION OF THE CATHETER, IT WOULD APPEAR THAT THE CATHETER'S DISTAL END WAS PINCHED AND THE PLATINUM COIL LOOSENED, MOST LIKELY WHILE BEING PUSHED THROUGH THE ONE WAY STOPCOCK OF THE GUIDING CATHETER WHEN REPORTEDLY, 'A LITTLE FRICTION WAS FELT'. WHILE EXCHANGING THE GUIDEWIRE THE WIRE GOT STUCK, AND THE RECOMMENDATIONS STATED IN THE PACKAGE INSERT WERE NOT FOLLOWED. THE INSERT STATES: WARNING: NEVER ADVANCE OR WITHDRAW AN INTRALUMINAL DEVICE AGAINST RESISTANCE. MOVEMENT OF CATHETER OR GUIDEWIRE AGAINST RESISTANCE COULD DISLODGE A CLOT, PERFORATE A VESSEL WALL, OR DAMAGE CATHETER AND GUIDEWIRE. IN SEVERE CASES, TIP SEPARATION OF  CATHETER OR GUIDEWIRE MAY OCCUR. FROM THE CONDITION OF THE RETURNED PRODUCT, THE MOST PROBABLE CAUSE FOR THE FAILURE OF THE DEVICE COULD BE A COMBINATION OF THE LACK OF FLUSHING, PUSHING THE CATHETER THROUGH THE STOPCOCK AND THE USE OF A GUIDEWIRE WHICH GOT STUCK. THIS INFO IS BASED ON INFO SUPPLIED TO CO WITHOUT CO'S INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT.
(IAB S/N UNK).  THE "RAPID GAS LOSS" ALARMS SOUNDED FROM THE PUMP.  THE IAB WAS REMOVED AND A SECOND WAS INSERTED.  THE IAB WAS NOT RETURNED TO CO FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY.  "MULTIPLE EVENT TO INITIAL COMPLAINT NUMER."
THIS FORM WAS COMPLETED BY THE MANUFACTURER.
A NURSE WENT TO USE A SEALED, STERILE 3CC SYRINGE. THE LID SNAPPED AS IT NORMALLY DOES WHEN THE SEAL IS BROKEN ON THE SYRINGE CONTAINER. SHE WENT TO ATTACH A NEEDLE AND NOTICED WHAT APPEARED TO BE DRIED OLD BLOOD NEAR THE TIP OF THE SYRINGE. THE SYRINGE WAS NOT USED.
ACTUAL SAMPLE WAS RECEIVED IN AN OPEN HARDPACK AND A DRIED BROWN SUBSTANCE WAS NOTED AT THE TIP OF THE SYRINGE. ANALYSIS REVEALED THE SUBSTANCE WAS BLOOD. THE LOT HISTORY WAS REVIEWED; NO REF. TO BLOOD OR FOREIGN MATTER FOUND IN SYRINGE BARRELS WAS NOTED. NO INJURY INCIDENTS WERE REPORTED BY EMPLOYEES USING THE ASSEMBLY MACHINE IN QUESTION. IT WOULD BE VERY DIFFICULT FOR BLOOD TO GET INTO THE SYRINGE BARREL AS THE ONLY TIME IT IS IN AN UPRIGHT POSITION IS WHEN IT IS IN AN ASSEMBLY AREA COMPLETELY CLOSED AND PROTECTED. BECAUSE THE SYRINGE WAS OPEN UPON RECEIPT, IT IS IMPOSSIBLE TO DETERMINE AT WHAT POINT THE BLOOD CONTAMINATION OCCURRED. NO OTHER REPORTS HAVE BEEN REPORTED AGAINST THIS LOT.
PT UNDERGOING CORONARY ARTERY BYPASS ON HEART/LUNG BYPASS. RESERVOIR BAG DEVELOPED A LEAK OR SEPARATION. DR HAD TO RUSH THRU PROCEDURE, FEARING OPENING MIGHT INCREASE, LARGER QUANTITIES OF BLOOD BE LOST, AND INCREASED POTENTIAL FOR INFECTION.
AN ALARM SOUNDED FROM THE PUMP AND THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING.
THIS FORM WAS COMPLETED BY THE MFR. SECION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. THE PENETRATION HAS THE CHARACTERISTICS TYPICALLY PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLING IS PRODUCED PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY. DEVICE LABEL CODE: 1738.
THE PVC TUBING THAT CONNECTS ONTO THE BIFURCATION DISCONNECTED ON THE BRONCHIAL LUMEN.
NOTE: EVALUATION PERFORMED ON RETAIN SAMPLE.
ANESTHESIA WAS INJECTING DRUGS AND NOTED THEY WERE BACKING UP.
A PT WAS TREATED ON 10/29/96 TO THE UPPER AND LOWER VERMILLION BORDERS. DURING TREATMENT TO THE UPPER VERMILION BORDER, THE PHYSICIAN OBSERVED THAT THE NEEDLE HAD "DISENGAGED" FROM THE SYRINGE; COLLAGEN MATERIAL EXTRUDED OUT OF THE SYRINGE AND THE NEEDLE FELL TO THE FLOOR. TREATMENT WAS DISCONTINUED, AND RESUMED WITH ANOTHER SYRINGE. NO INJURY OCCURRED TO THE PT. THIS EVENT IS BEING REPORTED AS AN MDR BECAUSE IT COULD RESULT IN A SERIOUS INJURY IF IT WERE TO RECUR.
DEV. #1 PROBE CODE: 1591 - NOT LABELED. DEV. #2 PROB CODE: 1415 - NOT LABELED.
ALL AVAILABLE INFO REGARDING THIS COMPLAINT WAS INVESTIGATED AND REVIEWED. ELECTRONIC TESTING OF THE RETURNED SENSOR WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING THE IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPECIFICATION.
WHEN DOING A PACER CHECK BEFORE IMPLANT, THE DEVICE COULD NOT BE INQUIRED.THE DEVICE WAS NOT IMPLANTED. NO PATIENT INFORMATION IS AVAILABLE.
THE OBSERVED "NO COMMUNICATION" WAS THE RESULT OF AN INTERMITTENT "OPEN" COMMUNICATION COIL, U-1. THE OPEN WAS AT THE WELD TAP STRAP FOR THE VDD SIDE OF THE COIL DUE TO AN OPERATOR ERROR DURING THE WELDING OPERATION.
PT WAS PLACED ON A HEPARIN DRIP AT 20CC'S AN HR. THE PUMP WAS SET CORRECTLY, USING 100 FT TUBING, AT 3. THE PT RECEIVED 400CC'S OF HEPARIN IN 9 HRS.
MANUFACTURER'S REPORT DATE 11/6/1996. FILE# 09/96-158 THE PUMP WAS RETURNED AND VISUALLY AND FUNCTIONALLY TESTED. THE PUMP WAS FOUND TO HAVE AN INCONSISTANCY (OVERINFUSING) IN RATE ACCURACY. INSPECTION OF THE PRESSURE PLATE REVEALED SIGNS OF WEAR. IT WAS DETERMINED THAT THE RUBBER PAD ON THE PRESSURE PLATE ASSEMBLY WAS WORN AND PREVENTED COMPLETE PINCHOFF OF THE DISPOSABLE RESULTING IN FREEFLOW. THE UNIT WAS ROUTED THROUGH OUR SERVICE DEPARTMENT FOR REPAIR AND RETURNED TO THE CUSTOMER. CO WILL RECOMMEND TO THE USER FACILITY TO REFER TO SERVICE BULLETIN #131(9/21/83) FOR MECHANSIM LEAK TEST DURING PERIODICAL INSPECTION OF THE DEVICE.
CONTROLLER SHUT OFF AND WOULD NOT COME BACK ON. MACHINE ALARM WENT OFF CONTINUOUSLY. SCREEN READ MALFUNCTION. CHECKED ON PT AND THEN SHUT OFF CONTROLLER. PT WAS BEING INFUSED WITH HEPARIN.
DEVICE LABEL CODE FOR F10 POSITION 1: 1701. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL.
EVENT COMPLICATIONS: UNK - REPORTED 8/26/96; NONE FROM THE EVENT - RPT'D 10/17/96. PATIENT'S CURRENT STATUS: ALIVE-RPT'D 10/17/96.
THE EARLY REPLACEMENT INDICATOR (ERI) ACTIVATED.
THE OBSERVED LONG CHARGE TIME WAS THE RESULT OF "HIGH LEAKAGE CURRENT" DUE TO INADEQUATE "REFORM RETENTION" OF THE HIGH VOLTAGE CAPACITORS, C6 AND C7. DURING THE CLINICAL TRIALS OF THIS DEVICE, THE ABOVE ANTICIPATED ADVERSE AFFECT WAS DISCOVERED, AND THE INVESTIGATORS WERE NOTIFIED. THE VENDOR OF THE CAPACITORS WAS CHANGED AS WELL AS THE TESTING PROCEDURE.  THE DATE ON G4 IS THE DATE THAT THE DEVICE WAS ANALYZED. WHEN IT WAS ORIGINALLY RETURNED, THERE WAS NO INDICATION OF A MALFUNCTION.
DURING AN AXILLARY CLEARANCE PROCEDURE. REPORTEDLY, THE CLIPS JAMMED IN THE JAWS. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/28/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. DUE TO A CLERICAL ERROR, THE STATUTORY MDR FILING DATE WAS MISSED.
COMPLAINANT ALLEGED THAT MEDICS WERE TRANSPORTING A 19 YEAR OLD FEMALE PATIENT WHO HAD ASTHMA. APPROXIMATELY FIVE MINUTES INTO THE TRANSPORT. TH UNIT WENT BLANK. THE MEDICS CHANGED THE UNITS BATTERY, BUT THE UNIT DID NOT REGAIN POWER. THE MEDICS OBTAINED ANOTHER UNIT (MFR UNK) AND COMPLETED THE TRANSPORT. THERE WAS NO ADVERSE EFFECT ON THE PATIENT. THE COMPLAINANT INDICATED THAT A FEW WEEKS PRIOR TO THE ALLEGED MALFUNCTION, THE UNIT'S MONITOR SCREEN DISPLAYED A "LOW BATTERY" MESSAGE DURING A MORNING SHIFT CHECK AND THEN LOST POWER. THE MEDICS CHANGED THE BATTERY SEVERAL TIMES, BUT THE UNIT DID NOT REGAIN POWER. AFTER APPROXIMATELY TWO HOURS, THE UNIT DID REGAIN POWER AND IT WAS RETURNED TO SERVICE.
ROUTINE COMPLAINT INVESTIGATION CONIRMS A FALSELY HIGH TEST RESULT COMPARED TO A LABORATORY RESULT. ANALYSIS INDICATES THERE IS A POSSIBILITY THAT THIS MALFUNCTION WERE IT TO RECUR FOR CERTAIN PTS UNDER CERTAIN CONDITIONS, COULD RESULT IN ADVERSE EFFECTS TO THE USER OF THE SYSTEM.
ALL AVAILABLE INFO REGARDING THIS COMPLAINT WAS INVESTGATED AND REVIEWED. ELECTRONIC TESTING OF THE RETURNED SENSOR WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. NO FURTHER SENSOR INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPECIFICATION.
ON 8/18/96 AT 19:00 HOURS, THE BALLOON WAS INSERTED INTO THE PT. ON 8/20 AT 8/20 AT 20:00HOURS, BLOOD FLOWED INTO THE TUBING. NO ALARM SOUNDED.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ASLO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPERANCE OF AN ABRASION MARK. THE PENETRARTION WITHIN AN ABRAISON MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. DEVICE LABEL CODE: 1738.
ON 7/31/96, LOSS OF OUTPUT WAS OBSERVED, THE PACER COULD NOT BE INQUIRED AND NO MAGNET RESPONSE WAS OBTAINED.  DURING THE REPLACEMENT OPERATION, PACING WAS SUDDENLY OBSERVED AT A RATE OF 76 PPM WHILE USING ELECTROCAUTERY. AFTER EXPLANTATION, THE SERIAL NUMBER OF THE DEVICE WAS NOT RECOGNIZED AS VALID. THE DOCTOR REQUESTS AN ANALYSIS.
OBSERVED NO OUTPUT, NO COMMS, NO MAGNET RATES WERE THE RESULT OF LOW MODULE VOLTAGE DUE TO BATTERY DISCHARGE. THE BATTERY IS EXPIRED-NORMAL.
RESIDENT PLACED IN CHAIR FOR CO TUB. CHAIR SEPARATED CAUSING RESIDENT TO FALL BACKWARD.
IT WAS APPARENT THAT THE STAFF PERSON DID NOT HAVE THE CHAIR LOCKED INTO PLACE NOR DID THEY HAVE THE SAFETY STRAP HOOKED UP. THE STAFF WERE AGAIN INSERVICED ON THE PROPER OPERATION OF THE CHAIR.
THE HUB OF THE CATHETER EXTENSION SET CRACKED & LEAKED.
SHUNT REPLACED ON 5/30/96. ON 5/31/96 PT HAD SYMPTOMS OF DECREASED AROUSABILITY, GROANS, INAPPROPRIATE VERBALIZATIONS, RUDIMENTARY WITHDRAWAL TO DEEP PAIN. PLACED ON VENTILATOR, CT DONE, PUPILS AT 3MM AND FIXED. EMERGENCY SURGERY PERFORMED TO REMOVE DEFECTIVE SHUNT AND IMPLANT NEW SHUNT. POSSIBLE LEAK. PROGNOSIS - AT RISK FOR COGNITIVE MOTOR SEQUELAE. IMPROVING NEUROLOGICALLY BUT NOT AT PRE-EPISODE BASELINE. POSSIBLE RIGHT FACIAL WEAKNESS. DECREASED UPWARD GAZE.
THE DEVICE HAD AN INTERMITTENT LOSS OF VENTRICULAR CAPTURE.
PRODUCT WIIL BE EVALUATED WHEN RECEIVED FROM USER FACILITY. FOLLOW-UP REPORT WILL THEN BE INITIATED.
ELECTIVE ENDOSCOPY; REMOVAL OF FEEDING TUBE. UNABLE TO REMOVE VIA ESOPHAGUS. BUMPER PIECE BECAME LODGED MID-ESOPHAGUS. PT TAKEN TO SURGERY FOR FEEDING TUBE BUMPER REMOVED.
(IAB S/N J1419024).  THE "GAS LOSS" ALARM SOUNDED FROM THE PUMP.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED  A LEAK IN THE MEMBRANE. THE PENETRATION HAS THE CHARACTERISTICS TYPICALLY PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECT TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY. DEVICE LABEL CODE: 1738.
PLEASE NOTE: THIS IS A FOLLOW-UP REPORT TO PROVIDE EVALUATION RESULTS (SECTION H6). THE DEVICES WERE RETURNED ON 10/14/96. LOT NUMBERS, EXPIRATION DATES, AND MFG DATES, FOR SECTIONS D6, D5, AND H4, RESPECTIVELY, ARE PROVIDED AS FOLLOWS: LOT#  9399011600, 9499146500, M60536000, 9399164800, 9499237500, 9499146400, M51194000. QTY 1, 1, 1, 1, 2, 1, 1. EXP DATE 02/1998, 05/1999, 02/2001, 08/1998, 07/1999, 05/1999, 03/1995. MFG DATE 02/1993, 05/1994, 02/1996, 08/1993, 07/1994, 05/1994, 03/2000. IT SHOULD BE NOTED THAT THE PATIENT HAD COLLECTED THE DEVICES AT HOME BEFORE INFORMING HIS HOME CARE THERAPIST OF THIS DEVICE PROBLEM. THE EVALUATION VERIFIED THE CRACKED TRACH HEADS. A NEW THICKER TRACH HEAD DESIGN HAS SINCE BEEN IMPLEMENTED. REPLACEMENT DEVICES WITH THE NEW DESIGN WERE SENT.
THE PATIENT HAD COLLECTED 6 TO 8 SIZE 6 CFS TRACHEOSTOMY TUBES THAT HAD CRACKED AT THE THREE O'CLOCK POSITION OF THE TRACH HEAD. NO PATIENT INJURY WAS REPORTED. THE CRACKS OCCURRED AFTER LESS THAN 2 MONTHS OF USE.
THE OBSERVED LONG CHARGE TIME WAS THE RESULT OF "HIGH LEAKAGE CURRENT" DUE TO INADEQUATE "REFORM RETENTION" OF THE HIGH VOLTAGE CAPACITORS, C6 AND C7. DURING THE CLINICAL TRIALS OF THIS DEVICE, THE ABOVE ANTICIPATED ADVERSE DEVICE AFFECT WAS DISCOVERED, AND THE INVESTIGATORS WERE NOTIFIED. THE VENDOR OF THE CAPACITORS WAS CHANGED AS WELL AS THE TESTING PROCEDURE. DATE IN G4 IS THE DATE THAT THE DEVICE WAS ANALYZED. WHEN IT WAS ORIGINALLY RETURNED, THERE WAS NO INDICATION OF A MALFUNCTION.
ALL AVAILABLE INFO REGARDING THIS COMPLAINT WAS INVESTIGATED AND REVIEWED. ELECTRONIC TESTING OF THE RETURNED SENSOR WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIAL. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPECIFICATION.
THE DEVICE HAD AN INTERMITTENT LOSS OF ATRIAL CAPTURE.
THERE WAS A LEAK IN THE INNER LUMEN. THE IAB WAS NOT RETURNED TO CO FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVAL. THIS ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. THIS FORM WAS COMPLETED BY THE MFR.
X-TUBE ASSEMBLY 17" X 15". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT LOAD PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/28/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
PT HAD AN EXTRAVASATION OF ADRIAMYCIN FROM THE IMPLANTED PORT CATHETER SITE WHICH RESULTED IN CHEMICAL MASTITIS. THE PT IS A 43-YR-OLD FEMALE WITH RIGHT BREAST CANCER AND IS STATUS POST RIGHT BREAST LUMPECTOMY. DURING THE USE OF THE CATHETER, THE PT COMPLAINED OF SYMPTOMS. THE CATHETER WAS REMOVED AND SENT TO THE CO FOR EVALUATION. NOTHING WAS FOUND WRONG WITH THE CATHETER. FOLLOWING MEDICAL TREATMENT OF THE CHEMICAL MASTITIS, THE PT ELECTED TO HAVE BILATERAL MASTECTOMIES. IT IS THE OPINION OF THE PHYSICIAN THAT THE PT NEEDED THE MASTECTOMY ON THE LEFT SIDE DUE TO THE ESTRAVASATION.
INSUFFICIENT INFO TO DETERMINE CAUSE OF REPORTED PROBLEM.
PT HAD ARTERIAL LINE IN ARM. ARTERIAL LINE SHEATH BROKE OFF IN PT ARTERY. BROKEN SHEATH WAS REMOVED BY SURGICAL INTERVENTION.
DURING A LAPAROSCOPIC LUNG REDUCTION PROCEDURE, THE INSTRUMENT WAS DIFFICULT TO CLOSE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS STATED THAT NO PT INJURY OCCURRED.
10/28/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
DEVICE LABEL CODE FOR F10. POSITION 1: 1701 AND POSITION 2: 1701. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL.
EVENT COMPLICATIONS: UNK - REPORTED 8/22/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 8/22/96.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS X-TUBE BROKE AT THE TOP JOINT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIE REPORT OR OTHER INFORMATION BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE ER STAFF WAS PREPARING FOR A CARDIAC PT TO ARRIVE AT THE FACILITY. A NURSE POWERED UP THE UNIT AND IT FUNCTIONED PROPERLY. "A FEW MINUTES LATER", THE NURSE NOTICED THAT THE UNIT'S MONITOR SCREEEN WAS BLANK. THEY RETURNED THE UNIT OFF AND ON AGAIN, CHANGED THE UNIT'S BATTERY, AND PLUGGED AND UNPLUGGED THE POWERCHARGER, BUT THE UNIT ONLY FUNCTIONED PROPERLY FOR A FEW MINITES. THE COMPLAINANT INDICATED THAT THE POWER AND READY LED'S WERE LIT ON THE POWERCHARGER. THE STAFF OBTAINED ANOTHER UNIT. THE UNIT WAS NOT IN USE ON A PT WHEN THE MALFUNCTION OCCURRED. THERE WAS NO ADVERSE EFFECT ON ANY PT.
TIP OF RESECTOSCOPE INNER SHEATH SEPARATED IN PT ON 5/14/96, SMALL CHIP NOT FOUND; SECOND INCIDENT ON 7/15/96.
INSUFFICIENT INFO TO DETERMINE PRECISE CAUSE OF PROBLEM. SOME POSSIBLE CAUSES ARE: A) UNDETECTED INCIPIENT SEPARATION CAUSED BY FREQUENT TORQUING OF TIP DURING INNER SHEATH AND REMOVAL; B) PREVIOUSLY DAMAGED (BURNED) TIP SUBJECTED TO ADD'L STRESSES; C) PREVIOUSLY DAMAGED (MECHANICALLY) TIP SUBJECTED TO ADDITIONAL STRESSES. THE UNUSUAL BURN MARKS INDICATE THERE MAY BE A SYSTEM PROBLEM AT THE HOSP.
DURING A LAPAROSCOPIC LUNG REDUCTION PRCEDURE, THE INSTRUMENT WAS DIFFICULT TO CLOSE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS STATED THAT NO PT INJURY OCCURRED.
10/28/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSISON OF INITIAL REPORT TO FDA BY MFG.
X-TUBE ASSEMBLY 18" X 17". DEALER CLAIMS X-TUBE BROKE AT THE BOLT HOLE WHEN MAKING A TURN.
ON THE TWO SEPARATE OCCASIONS, THE UNIT DISPLAYED A "CHECK ELECTRODES" MESSAGE. THE FIRST MALFUNCTION OCCURRED WHEN MEDICS ATTEMPTED TO ANALYZE A PT (AGE AND GENDER UNK). THE UNIT WAS IN AED MODE AND THE MULTI-FUNCTION ELECTRODES WERE BEING USED. THE UNIT'S MONITOR SCREEEN DISPLAYED THE ERROR MESSAGE AND THE MEDICS TRANSFERRED THE PT TO ANOTHER UNIT (MFR UNK). THERE WAS NO ADVERSE EFFECT ON THE PT. THE MEDICS WERE UNABLE TO DUPLICATE THE MALFUNCTION AND THE UNIT WAS RETURNED TO SERVICE. SOME TIME LATER, MEDICS WERE MONITORING A PT (AGE AND GENDER UNK) USING A THREE LEAD CABLE AND THE UNIT WAS IN AED MODE. WHEN THE ERROR MESSAGE APPEARED, THE MEDICS SWITCHED THE UNIT TO MANUAL MODE AND THEY WERE ABLE TO OBTAIN AN ECG TRACE. THERE WAS NO ADVERSE EFFECT ON THE PT. THE MEDIC EVALUATED THE UNIT A SECOND TIME AND THEY WERE STILL UNABLE TO DUPLICATE THE MALFUNCTION.
AT THE COMPLETION OF TRIGGER POINT INJECTION PROCEDURE, THE NEEDLE WAS REMOVED FROM THE INJECTION SITE AND WAS NOTED TO BE BROKEN FROM NEEDLE HUB. PT ADMITTED AND HAD SURGERY FOR "INCISION AND REMOVAL OF METALLIC FOREIGN BODY IN THE RIGHT HIP AREA."
PROBLEM MOST LIKELY OCCURRED DURING IMPROPER ASSEMBLY OR DIASSEMBLY OF THE CFR INNER AND OUTER SHEATHS.
THE OBSERVED LONG CHARGE TIME WAS THE RESULT OF "HIGH LEAKAGE CURRENT" DUE TO INADEQUATE "REFORM RETENTION" OF THE HIGH VOLTAGE CAPACITORS, C6 AND C7. DURING THE CLINICAL TRIALS OF THIS DEVICE, THE ABOVE ANTICIPATED ADVERSE DEVICE AFFECT WAS DISCOVERED, AND THE INVESTIGATORS WERE NOTFIED. THE VENDOR OF THE CAPACITORS WAS CHANGED AS WELL AS THE TESTING PROCEDURE. THE DATE IN G4 IS THE DATE THAT THE DEVICE WAS ANALYZED. WHEN IT WAS ORIGINALLY RETURNED, THERE WAS NO INDICATION OF A MALFUNCTION.
STAFF MEMBERS WERE ATTEMPTING TO DEFIBRILLATE A PT (AGE AND GENDER UNK) DURING A SURGICAL PROCEDURE. WHEN THEY ATTEMPTED TO CHARGE THE UNIT, "STATUS 51", "STATUS 104" AND "STATUS 66" MESSAGES APPEARED ON THE UNIT'S MONITOR SCREEN. THE STAFF OBTAINED ANOTHER UNIT (MFR UNK) AND DEFIBRILLATED THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT.
REMOTE BOX W/ARM R. DEALER ALLEGES CHAIR HAS TENDENCY TO TAKE OFF ALL BY ITSELF.
DISTRIBUTOR FAILED TO RETURN PARTS FOR EVALUATION.
MEDICS WERE TREATING A MALE PT (AGE UNK) WHO WAS IN A CODE SITUATION. THE MEDICS DEFIBRILLATED THE PT FOUR TIMES. AFTER THE FOURTH DEFIBRILLATION ATTEMPT WAS DELIVERED, THE UNIT'S MONITOR SCREEN DISPLAYED "STATUS 104", STATUS "105", "STATUS 60" AND "CAN NOT DUMP" MESSAGES. THE UNIT WAS ABLE TO MONITOR THE PT'S RHYTHM PROPERLY AND THE MEDICS DETERMINED THAT THE PT DID NOT REQUIRE ADD'L DEFIBRILLATION. THERE WAS NO ADVERSE EFFECT ON THE PT.
EVALUATION OF THE UNIT INDICATES THAT THE UNIT HAD BEEN DROPPED.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY HAS OCCURRED.
9/18/96: MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
MEDICS ATTEMPTED TO MONITOR A PT (AGE AND GENDER UNK) AND THE UNIT'S MONITOR SCREEN ONLY DISPLAYED A DOTTED LINE. THE MEDICS CHANGED THE UNIT'S BATTERY AND TRIED TO MONITOR IN ALL THREE LEADS, BUT THE UNIT CONTINUED TO DISPLAY A DOTTED LINE FOR AN ECG TRACE. THE UNIT'S MONITOR SCREEN DID NOT DISPLAY ANY ERROR MESSAGES. THERE WAS NO ADVERSE EFFECT ON THE PT.
DURING A DIALYSIS TREATMENT, THE FOUR POSITION LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE RETURNED FOUR-POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT THE CLAMP HOLDER WAS BROKEN. THE TABS ON THE WHITE CLAMP INSERT HOLDER WAS BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. SAFETY ANALYSIS: IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR # 960027. CUSTOMER CONTACTED? N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
A BALLOON RUPTURED ON THE FIRST INFLATION AT EIGHT ATMOSPHERES DURING A BILATERAL ILIAC AND POPLITEAL ANGIOPLASTY VIA A CONTRALATERAL APPROACH. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS NOT BEEN RECEIVED. THEREFORE, NO FAILURE ANALYSIS WAS AVAILABLE. BALLOON OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
DURING THE PROCEDURE THE SHEATH OF THE DEVICE KINKED. REPORTEDLY, TWO HOLES WERE ALSO DETECTED IN THE SHEATH. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
ALL AVAILABLE INFO REGARDING THIS COMPLAINT WAS INVESTIGATED AND REVIEWED. ELECTRONIC TESTING OF THE RETURNED SENSOR WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THIS TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPECIFICATION.
REMOVAL AND REPLACEMENT OF THORACIC-LUMBAR BROKEN INSTRUMENTATION.
CONCLUSION STATEMENT: UF HAS BEEN CONTACTED ON THREE DIFFERENT OCCASIONS. NO ADD'L INFO HAS BEEN RECEIVED. THEREFORE, CO CAN NOT IDENTIFY CATALOG OR LOT NUMBER OF PRODUCT INVOLVED. CO IS UNABLE TO REACH ANY CONCLUSIONS ON THIS INCIDENT BECAUSE ACCOUNT REFUSES TO PROVIDE ANY INFO.
DURING A LAPAROSCOPIC LUNG REDUCTION PROCEDURE, THE INSTRUMENT WAS DIFFICULT TO CLOSE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE  PROCEDURE, THE HOSP HAS STATED THAT NO PT INJURY OCCURRED.
10/28/96-WEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INTITIAL REPORT TO FDA BY MFG.
WHEN THE IAB WAS INSWETED INTO THE SHEATH, THE SHEATH "SCRINCHED UP" AND THERE WAS RESISTANCE WHEN TRYING TO INSERT THE IAB INTO THE HEMOSTASIS VALVE.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE CODE LABEL:1738. A 10 FRENCH, 6 INCH SHEATH ASSEMBLY (CONSISTING OF THE SHEATH AND ATTACHED WHITE HEMOSTASIS VALVE) WAS RETURNED FOR EVALUATION. ON VISUAL EXAMINATION THE SHEATH ASSEMBLY WAS FOUND TO BE COMPLETELY IN PLACE OVER THE FOLDED BALLOON MEMBRANE. THE SHEATH TUBING WAS NOTED TO BE SEVERELY RIBBED. THE INNER LUMEN WITHIN THE CATHETER TUBING NEAR THE METAL SLEEVE WAS NOTED TO BE ELONGATED AND KINKED. THE MEMBRANE AT FTHE PROXIMAL TAPER WAS OVBSERVED TO BE SEVERELY STRETCHED. THE SHEATH I.D. AND CATHETER O.D. WERE MEASURED AND FOUND TO BE IWTHIN CO'S MANUFACTURING SPECEIFICATION. AFTER THE SHEATH WAS REMOVED FORM THE FOLDED MEMBRANE, IT WAS POSSIBLE TO PASS A FOLDED LABORATORY STAT DL 9.5 FR. 34CC IAB (WITH A VACUUM DRAWN AND MAINTAINED ON THE DEVICE) THROUGH THE ENTIRE SHEATH/HEMOSTASIS ASSEMBLY. OTHER THEN BIENG SEVERELY KINKED, NO MANUFACTURING DEFECT WAS FOUND IN THE RETURNED SHEATH. THE SHEATH IS MADE OF A SOFT MATERIAL SO AS TO NOT INJUR THE PT'S ARTERY DURING THE INSERTION PROCEDURE. THE GENERAL, DIFFICULTY  ADVANCING THE SHEATH INTO THE PT OR THE IAB INTO THE SHEATH BE ATTRIBUTED TO ONE OR MORE OT THE FOLLOWING: 1. DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. 2. THE PT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR SHEATH INSERTION.
A FILTER DID NOT FULLY OPEN AFTER DEPLOYMENT VIA THE JUGULAR APPROACH. MANIPULATION WITH A SNARE RESULTED IN REPOSITIONING THE FILTER APPROX ONE TO TWO CENTIMETERS CEPHALED. THE PHYSICIAN FELT THE PT WAS ADEQUATELY PROTECTED AND NO FURTHER ACTION WAS NECESSARY. THE PT CONDITION IS FINE. THIS DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO FILTER PLACEMENT WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "AN INFERIOR VENA CAVOGRAM MUST BE PERFORMED PRIOR TO VENA CAVA FILTER INSERTION. THIS PROCEDURE DETERMINES CAVAL PATENCY AND DIAMETER AND IS USED TO EVALUATE THE INFERIOR VENA CAVA FOR THE PRESENCE OF THROMBUS AND CONGENITA ANOMALIES. DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER. IN MOST CASES, A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE."
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTIONS WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
THE RETURNED FOUR-POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT THE CLAMP HOLDER WAS BROKEN. THE TABS ON THE WHITE CLAMP INSERT HOLDER WAS BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSTION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027. CUSTOMER CONTACTED? N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
DURING THE PROCEDURE THE SHEATH OF THE DEVICE KINKED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR ANALYSIS.
DURING A LAPAROSCOPIC SIGMOID RESECTION CLIPS SHOT OUT OF THE DEVICE.  THIS OCCURRED WITH THE FIRST TWO FIRINGS OF THE DEVICE. THE CLIPS WERE REMOVED FROM THE ABDOMEN.  A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE.  THERE  WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION; BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED.
CUSTOMER REPORTED THEY FELT THE OUTPUT OF THE VAPORIZER WAS LOWER THAN EXPECTED. THERE WAS NO REPORTED PT INJURY. CO'S INVESTIGATION INTO THE REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
INVESTIGATION/CONCLUSION: THE UNIT WAS RETURNED TO THE MFG SITE FOR INVESTIGATION. THE UNIT WAS TESTED AND THE OUTPUT WAS FOUND TO BE HIGH TO SPEC. THE INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THE REPORTED COMPLAINT WAS DUE TO SCRATCHING AND/OR FLATNESS ISSUES RELATED TO THE SEALING FACE OF THE ROTARY VALVE. CHANGES IN MFG PROCESSES HAVE GREATLY REDUCED THESE ISSUES. CHANGES WERE IMPLEMENTED INTO THE MFG, REFURBISHING AND SVC PROCESSES IN 6/97.
PT WAS RECEIVING A SINGLE CORONARY STENT TO HIS PROXIMAL LAD; WHEN A BALLOON PTCA CATHETER USED FOR PRE AND PEST DILATION RUPTURED CAUSING A DISSECTION OF PT'S CORONARY ARTERY. THIS REQUIRED IMMEDIATE SURGICAL INTERVENTION (BYPASS/CABG). APPEARS THE PT WILL RECOVER FROM THIS EVENT.
THE PERIPHERAL DILATATION CATHETER RUPTURED DURING A PTA PROCEDURE. THE BALLOON FRAGMENTED AND A "SNARE" DEVICE HAD TO BE USED TO REMOVE THE FRAGMENTS. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSPITAL OR DISTRIBUTOR. EVALUATION SUMMARY: THE RESULTS OF THE ANALYSIS REVEALED THAT THE PERIPHERAL DILATATION CATHETER HAD A LONGITUDINAL RUPTURE PRESENT. ENGINEERING CONCLUDED THAT THE CAUSE OF THE RUPTURE WAS MOST LIKELY ATTRIBUTED TO THE BALLOON BEING INFLATED HIGHER THAN THE PRESSURE RECOMMENDED IN THE INSTRUCTIONS FOR USE. QUALITY ENGINEERING HAS REVIEWED THE COMPLAINT DATA FOR THIS TYPE OF COMPLAINT AND FOUND THAT THE OCCURRENCE IS EXTREMELY LOW. QUALITY ASSURANCE CONTINUES TO MONITOR THE DEVICE FOR THIS TYPE OF COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPARTMENT.
AN INTRA-AORTIC BALLOON PUMP WOULD NOT AUGMENT. THE PT WAS TRANSFERRED TO ANOTHER INTRA-AORTIC BALLOON PUMP WITHOUT FURTHER INCIDENT. THERE WERE NO PT COMPLICATIONS INVOLVED. THE BALLOON PUMP WAS EVALUATED AT THE USER FACILITY BY A SERVICE TECHNICIAN. IT WAS INDICATED THE DOME ASSEMBLY CONTAINED TOO MUCH AIR AND WAS NOT ADEQUATELY CHARGED PRIOR TO USE. CO'S ROUTINE MAINTENANCE SCHEDULE ADDRESSES THIS ISSUE AND STATES TO RECHARGE THE SAFETY DOME BEFORE CONNECTING THE CONSOLE TO THE PT'S CATHETER TUBING. CO BELIEVES APPROPRIATE MAINTENANCE OF THIS DEVICE COULD HAVE PREVENTED THS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE.
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT CONCLUDED IN THIS SECTION OR ANY OTHER SECTIONS WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECIEVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWENT LEAK TESTING DISCLOSED NO LEAKS IN THE IAB. THE IAB INFLATED AND FUNCTIONED NORMALLY WHEN ATTACHED TO THE SYSTEM 90 IN THE LAB. THE DESCRIPTION OF THE EVENT AND PHYSICAL EVIDENCE INDICATE THAT 'CHANNELING', BLOOD TRAVELING BETWEEN THE FOLDS OF THE BALLOON MEMBRANE, WAS PERCEIVED AS A LEAK. THIS CHANNELING PHENONOMEN IS INCORPORATED IN DATASCOPE'S INSTRUCTIONS FOR USE FOR ALL STAT IABS. DEVICE LABEL CODE: 1738.
THE FOLLOWING WAS ALSO REPORTED ON 9/18/96: THE BALLOON WAS INSERTED INTO THE PATIENT AT BEDSIDE. AT FIRST, DIFFICULTY WAS ENCOUNTERED LOCATING THE PATIENT'S FEMORAL PULSE. THE NEEDLE AND SHEATH WERE INSERTED WITHOUT A PROBLEM. THE BALLOON COULD ONLY BE ADVANCED SO FAR. THERE WAS NO ARTERIAL WAVEFORM.
DURING THE PROCEDURE THE SHEATH OF THIS DEVICE KINKED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
AN ELDERLY MALE PT HAS BEEN TESTED MANY TIMES OVER THE PAST YEAR (EXACT DATES UNAVAILABLE) USING THE ASSAY. IN THE SPRING, THE PT'S PSA RESULT WAS 35 NG/ML AND IN AUGUST, THE PT'S PSA RESULT WAS 65 NG/ML. THE PHYSICIAN DID NOT BELIEVE THE 65 NG/ML RESULT AND SENT A SAMPLE TO ANOTHER CLINIC FOR TESTING. THE PSA RESULT WAS 1.8 NG/ML. THE PT HAD A BIOPSY PERFORMED SOME TIME AGO BUT THE REPORTING INDIVIDUAL DID NOT BELIEVE IT WAS AS A RESULT OF THE PSA RESULTS. THE PT WAS SUBSEQUENTLY DIAGNOSED WITH CHRONIC PROSTATITIS. NO TESTING WAS PERFORMED AS THE KIT LOT NUMBER WAS NOT KNOWN, AND NO SAMPLE WAS RETURNED FOR EVAL.
THE SUBMISSION OF THIS MDR IS REQUIRED OF DEVICE MFRS BY 21CFR803. NEITHER THE SUBMISSION OF INFO BY CO PURSUANT TO THIS RULE, NOR THE PUBLIC RELEASE OF SUCH INFO, CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CONNECTION BETWEEN THE PRODUCT AND ANY DEATH OR INJURY. NOTE: THAT THERE WAS NO METHOD OR RESULTS CODES NOTED AS THE DEVICE LOT NUMBER WAS UNK BY THE REPORTING INDIVIDUAL AND NO SAMPLE WAS RETURNED FOR EVAL.
THERE WAS A CRACK OBSERVED IN THE BOTTOM OF THE BLOOD PUMP. IT WAS NOT USED ON A PT. THE BLOOD PUMP HAS BEEN RETURNED FOR EVAL.
CUSTOMER REPORTED THEY FELT THE OUTPUT OF THEIR VAPORIZER WAS HIGHER THAN EXPECTED. THERE WAS NO REPORTED PT INJURY. CO'S INVESTIGATION INTO THE REPORTED EVENT IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
INVESTIGATION/CONCLUSION: THE UNIT WAS RETURNED TO THE MFG SITE FOR INVESTGATION. THE UNIT WAS TESTED AND THE REPORTED COMPLAINT WAS CONFIRMED. THE INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THE REPORTED COMPLAINT WAS DUE TO SCRATCHING AND/OR FLATNESS ISSUES RELATED TO THE SEALING FACE OF THE ROTARY VALVE. CHANGES IN MFG PROCESSES HAVE GREATLY REDUCED THESE ISSUES. CHANGES WERE IMPLEMENTED INTO THE MFG, REFURBISHING AND SVC PROCESSES IN 6/97.
HUNDRED % O2 SUCTION MODE ACTIVATED BY NURSE. VENTILATOR "SHUT DOWN" - NO LIGHTS, NO ALARMS NO FUNCTION AT ALL. NURSE IMMEDIATELY REMOVED PT FROM VENTILATOR AND MANUALLY VENTILATED WHILE RESPIRATORY THERAPIST "CHANGED  OUT" RESPIRATOR. VENTILATOR TAKEN OUT OF SVC. PT DID NOT SUFFER ANY ADVERSE EFFECT AS A RESULT OF SPONTANEOUS VENTILATOR "SHUT DOWN."
THE FOUR-POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT THE CLAMP HOLDER WAS BROKEN. THE TABS ON THE WHITE CLAMP INSERT HOLDER WAS BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. SAFETY ANALYSIS: IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THE COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027. CUSTOMER CONTACTED? N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
DURING THE PROCEDURE THE GASKET OF THIS DEVICE DISLODGED. REPORTEDLY, THE PT EXPERIENCED SOME BLOOD LOSS, BUT REQUIRING NO MEDICAL OR SURGICAL INTERVENTION. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED.
A BALLOON BURST AT SIX ATMOSPHERES DURING AN ILIAC ANGIOPLASTY OF A HIGHLY CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THIS DEVICE WAS DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. CO'S FOLLOW UP REVEALED THE LESION WAS HIGHLY CALCIFIED, THEREFORE CO BELIEVES THIS FACTOR CONTRIBUTED TO THE EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING HE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "DUE TO THE THIN WALL THICKNESS OF THE BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
INFO SUPPLIED IN SECTION FF WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO HE FDA.
8/30/96-INFILTRATION OF CHEMOTHERAPY AGENT INTO LT UPPER ARM. 9/24/96-LEAKING OF CONTRAST MATERIAL SEEN AT PROXIMAL END OF CATHETER. 9/26/96-INSPECTION AFTER REMOVAL SHOWING FRACTURE OF THE  CATHETER AT THE INFERIOR SIDE OF THE HUB CONNECTOR.
THE NEW CLEAR HEMOSTASIS VALVE LEAKED. IABP CONTINUED WITHOUT ANY FURTHER PROBLEMS.
DUE TO MALFUNCTION OF FEEDING PUMP, VENTILATOR-DEPENDENT PT RECEIVED 240 ML OF PULMOCARE VIA GASTROSTOMY TUBE (GT) OVER 90 MINS, INSTEAD OF 90 ML AS ORDERED, RESULTING IN EPISODE OF VOMITING. PT REMAINED STABLE, WITHOUT ADVERSE EFFECT. GT FEED HELD FOR SIX HRS.
THE GASKET OF THIS DEVICE DISLODGED DURING THE PROCEDURE. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR ANALYSIS.
THE PORTAL WAS RETURNED WITH AN 15 1/2 INCH LENGTH OF CATHETER ATTACHED. MICROSCOPY EXAMINATION OF THE PORTAL OUTLET TUBE AND CATHETER REVEALED THAT THERE WAS A 1/8TH INCH SLIT ALONG THE LENGTH OF THE CATHETER OVER THE PORTAL OUTLET TUBE. DELTEC PERSONNEL WERE UNABLE TO DETERMINE THE CAUSE OF THE OBSERVED DAMAGE.
PRODUCT SPECIALIST REPORTS SHE WAS DEMONSTRATING A SAFETY SYRINGE BY ATTACHING THE NEEDLE TO THE SYRINGE, SHE DEMONSTRATED THE TRANSPORT AND LOCKING OF SAFETY SHIELD BY BANGING THE SYRINGE ON TABLE. THE LOCKING MECHANISM DID NOT FUNCTION PROPERLY.
PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
WHILE PACING PT, THE PACER STOPPED PACING AND LATER STARTED PACING AGAIN. THE OBSERVATIONS UPON WHICH THESE ALLEGATIONS WERE BASED WAS NOT REPORTED.
THE LOCAL CO SVC REP OBSERVED PROPER OPERATION OF DEVICE AND ATTACHED PACING CABLE, THE RPTR EXPRESSED THAT THE EVENT MAY HAVE BEEN THE RESULT OF  OPERATOR ERROR. THE REP PROVIDED THE FACILITY WITH ADD'L PRODUCT TRAINING AND RETURNED THE DEVICE TO USE. EXCEPT AS PROVIDED BY 21 CFR 803.56 CO DOES NOT INTEND TO SUBMIT ADD'L INFO ON THE EVENT TO FDA.
PUMP INFUSED TPN AT A FASTER RATE THAN THE RATE THAT WAS SET. 1000CC OF TPN INFUSED FROM 5 PM TO 11 AM. PUMP WAS THEN CHANGED AND D10W WAS HUNG AFTER MALFUNCTION WAS IDENTIFIED.
ONE PERSON INVOLVED IN THIS EVENT. CO HAS BEEN NOTIFIED BY AN ATTORNEY OF AN ALLEGED MALFUNCTION OF CO'S ATRIAL LEAD, WHICH REQUIRED EXPLANTATION. THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. CO DOES NOT HAVE POSSESSION OF THE LEAD. WITHOUT SUBSEQUENT ANALYSIS OF THE SUBJECT LEAD, CO IS UNABLE TO FULLY EVALUATE A REPORTED EVENT. HOWEVER, CO IS TRYING TO LOCATE THE LEAD AND IF FOUND CO WILL PERFORM AN ANALYSIS. UPON RECEIPT OF ANY FURTHER INFO CO WILL RESPOND ACCORDINGLY. ALL RECORDS SHOW THE LEAD FUNCTIONED PROPERLY AT FINAL INSPECTION ON 4/28/88. THE LENGTH OF LEAD IMPLANT IS APPROX 7 YEARS, 6 MONTHS. THE FILING OF THIS REPORT IS REQUIRED BY LAW. CO DOES NOT CONSIDER THIS REPORT OR ITS CONTENTS TO BE AN ADMISSION THAT A PRODUCT DISTRIBUTED BY CO IS DEFECTIVE, OR THAT A PRODUCT DISTRIBUTED BY CO HAS CAUSED A DEATH OR SERIOUS INJURY. THIS REPORT MAY BE BASED UPON INCOMPLETE AND/OR UNCONFIRMED INFO.
FREQUENCY OF OCCURRENCE IN THE LABELING? UNK. SEVERITY OF OCCURRENCE IN THE LABELING? UNK.
PT WITH INVASIVE BLADDER CANCER ADMITTED WITH GROSS HEMATURIA REQUIRING CONTINUOUS BLADDER IRRIGATIONS. UNDERWENT TURBT AND FULGURATION, PERINEAL URETHROSTOMY AND EVACUATION OF BLADDER CLOTS. ON REMOVAL OF RESECTOSCOPE, THE DISTAL END AND INSULATING PORTION BROKE OFF AND WAS SEEN IN THE BLADDER. THIS PIECE WAS REMOVED WITH A CATHETER. NO ACTIVE BLEEDING WAS NOTED ON FINAL INSPECTION. THE PT REMAINS IN THE HOSP FOR HIS UNDERLYING CONDITION (CONTINUED HEMATURIA).
THE IAB LEAKED. BLOOD WAS NOTED IN THE BALLOON.
INSUFFICIENT INFO TO DTERMINE CAUSE OF REPORTED PROBLEM.
ACCELERATED HEART RATE OCCURRED ANYTIME SINCE 12/94. FINALLY IPG REMOVED 8/96. ON 10/21/96 DR'S OFFICE NOTIFIED PT OF BATTERY WARNING LETTER FOR IPG. PT CALLED FDA TO INQUIRE ABOUT WARNING LETTER AND PREVIOUS RECALL Z8542.
PUMP WAS NOT RETURNED TO THE MFR FOR EVAL. THE HOSPITAL'S BIOMED TESTED THE PUMP AND NO FAULT WAS FOUND. THE HOSPITAL SUSPECTS POSSIBLE MATERIAL MISLOAD OF THE SET. ADD'L INSERVICING WILL BE RECOMMENDED TO THE HOSPITAL ON THE PROPER PROCEDURE FOR LOADING OF THE IV SET PER THE DIRECTION FOR USE, PAGE 9, WHICH STATES, "CLOSE THE MECHANISM BY PUSHING THE ORANGE LATCH TO THE LEFT. VERIFY THE TUBING IS FULLY WITHIN THE MECHANISM AND THE AIR-IN-LINE DETECTOR. DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH."
THE DEVICE LEAKS. THE LIQUID COMES OUT OF THE THREAD. THIS EVENT DID NOT CAUSE ANY ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
DEVICE NOT MANUFACTURED IN THE U.S. DEVICE RETURNED DIRECTLY TO MFR. EVAL TO BE PERFORMED AT MANUFACTURING FACILITY. F1-F14: HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN RECEIVED FROM A FOREIGN AFFILIATE. UF INFO IS UNOBTAINABLE.
WHEN SWITCHING FROM MANUAL MODE TO PRESSURE CONTROL, THE MANUAL BAG "RECEIVES" A COUPLE OF PRESSURE CONTROL BREATHS, WHEN SWITCHING BACK TO MANUAL THE POTENTIAL EXISTS TO DELIVER "HIGH" PRESSURE TO THE PT VIA THE RESIDUAL PRESSURE IN THE MANUAL BAG.
81 -THE DEVICE(S) WILL NOT BE EVAUATED. 200 -THE ISSUE DESCRIBED, IS THE USER'S PERCEPTION THAT THE MANUAL BAG IS OVER INFLATING.
INFUSION OF VERSED VIA PUMP-40CC/4MG INFUSED OVER 15 MINUTES.
AMBULANCE PERSONNEL WERE ATTENDING TO AN ASYSTOLIC PT. AN ATTEMPT TO EXTERNALLY PACE THE PT WAS MADE AND IT WAS REPORTED THAT SEVERAL MINUTES AFTER CAPTURE WAS ACCOMPLISHED, THE DEVICE SPONTANEOUSLY DROPPED TO 0MA. NO ALARMS WERE NOTED. THE OPERATOR WAS ABLE TO RESTART AND CONTINUE PACING WITHOUT FURTHER EVENT. THE PT WAS NOT RESUSCITATED. THE REPORTER STATED THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THIS OPINION WAS BASED ON THE REPORTER'S ASSESSMENT OF THE PT'S VIABILITY AND THE ABILITY TO RESTART AND CONTINUE PACING.
THE DEVICE HAS BEEN RETURNED TO THE CUSTOMER FOR USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA. SECTION A-ALL PT RELATED INFO MADE AVAILABLE BY THE REPORTER IS PROVIDED IN THIS REPORT. SECTION F-F10. CODE #2199-LABELING NA.
ON 4/25/96 PT UNDERWENT REMOVAL OF SILICONE BREAST IMPLANTS AND EXCHANGE FOR SALINE FILLED IMPLANTS BILATERALLY. ON 6/6/96 SHE HAD DEVELOPED INFECTION OF THE IMPLANTS, BILATERALLY, WITH LEFT EXPOSURE. BOTH IMPLANTS WERE REMOVED.
THE DEFIBRILLATOR CHARGED TO 200 JOULES BUT WOULD NOT DISCHARGE ENERGY TO THE PT. THE OBSERVATION OR OBSERVATIONS UPON WHICH THIS ALLEGATION WAS BASED WAS NOT REPORTED.
THE LOCAL FACTORY SVC REP OBSERVED PROPER DEVICE OPERATION THROUGH FULL PREFORMANCE AND FUNCTIONAL TESTING AND RETURNED THE DEVICE TO THE FACILITY FOR USE. THE RTPR STATED THAT THE EVENT WAS POSSIBLY THE RESULT OF OPERATOR ERROR. THE RPTR EXPRESSED THAT A CO OFFER OF ADD'L TRAINING FOR THE STAFF WAS NOT NECESSARY. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA.
PUMP WAS NOT RETURNED TO THE MFR FOR EVAL. THE HOSPITAL'S BIOMED TESTED THE PUMP AND NO FAULT WAS FOUND. THE HOSPITAL SUSPECTS POSSIBLE MISLOAD OF THE SET. ADD'L INSERVICING WILL BE RECOMMENDED ON THE PROPER PROCEDURE FOR LOADING OF THE IV SET PER THE DIRECTIONS FOR USE, PAGE 9, WHICH STATES, "DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH." MEDWATCH REPORT INDICATES PUMP IS AVAILABLE FOR EVALUATION, HOWEVER THE HOSPITAL IS NOT RETURNING THE PUMP AND HAS PUT IT BACK INTO USE. SECTION F-H WAS COMPLETED BY THE MFR.
THE IAB WAS INSERTED INTO THE PT ON 8/15/96. ON 8/21/96 AFTER IABP FOR ABOUT SIX DAYS, AN ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE BALLOON. THE IAB WAS INSERTED. THE TIMING WAS 1:1 AND AUGMENTATION WAS NOT MAXIMUM.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FROM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPERANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE IABP. DEVICE LABEL CODE: 1738.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECSTECTOMY. IT WAS REPORTED THE DEVICE MISFIRED. THERE WAS NO CONSEQUENCE TO THE PT.
DURING CLINICAL INSERVICING AT THE HOSPITAL, THE DEVICE WAS REPORTED TO HAVE THE FOLLOWING PROBLEMS: INTTERMITTENT SWITCHING BETWEEN BATTERY AND AC POWER, SYSTEM FAILED ON POWER-UP. EVAL FOUND A POOR SOLDER CONNECTION ON THE POWER SUPPLY BOARD.
A LARGE ANIMAL DR (VET) REPORTED SHE FOUND A NEEDLE IN A BOX WITH BLOOD ON IT. SHE DOESN'T KNOW IF THE NEEDLE WAS PREVIOUSLY USED. SHE STATED THE BLOOD WAS DRY AND SEEN ON BOTH THE BUSINESS END AND BUTT ENDS OF THE NEEDLE. SHE RETRACTED THE RUBBER VALVE AND SAW THE BLOOD. THE DR STATED, SHE'S "SURE IT'S HORSE BLOOD". SHE THINKS IT'S POSSIBLE SOMEONE AT HER CLINIC USED THE NEEDLE, RECAPPED IT, AND PUT IT BACK IN THE BOX. SHE REPORTED THE BOX IT WAS TAKEN FROM WAS "OVERFILLED".
INVESTIGATION IS IN PROGRESS. SAMPLE WAS RECEIVED FOR EVAL. VISUAL EXAM CONFIRMED BROWNISH SUBSTANCE ON NEEDLE END. FURTHER EVAL (TO IDENTIFY SUBSTANCE) IS BEING PERFORMED. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED NO LEAKS IN THE IAB. THE IAB INFLATED AND FUNCTIONED NORMALLY WHEN ATTACHED TO THE SYSTEM 90 IN THE LAB. THE DESCRIPTION OF THE EVENT AND PHYSICAL EVIDENCE INDICATE THAT 'CHANNELING'. BLOOD TRAVELING BETWEEN THE FOLDS OF THE BALLOON MEMBRANE, WAS PERCEIVED AS A LEAK. THIS CHANNELING PHENONOMEN IS INCORPORATED IN DATASCOPE'S INSTRUCTIONS FOR USE FOR ALL STAT IABS. DEVICE LABEL CODE: 1738.
REPORTED TO DATASCOPE ON 9/20/96: DURING INSERTION, BLOOD WAS NOTED COMING FROM THE CATHETER. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE MISFIRED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B3,6,7; D10: CONTACTED HOSPITAL, NO FURTHER INFO WAS AVAILABLE. D5,6: H4: INFO COULD NOT BE DETERMINED. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
THE DEVICE WAS USED DURING AN ECTOPIC PREGNANCY. THE INITIAL BLIE LOAD DISLODGED FROM THE DEVICE AFTER DEPRESSING THE BACK UNLOCK BUTTON. THE CARTRIDGE FELL INTO THE PT. THE RELOAD WAS RETRIEVED. THE DEVICE FIRED AND STAPLED ADEQUATELY. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B3,6,7; D10: ATTEMPTED TO CONATCT SURGEON, INFO UNAVAILABLE. D5,6; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
DURING THE PROCEDURE THE HUB OF THE DEVICE BROKE OFF AND REMAINED LODGED IN THE INCISION, SITE OF THE PT. HOWEVER, THE PIECE WAS SUCCESSFULLY REMOVED WITH THE USE OF FORCEPS. THE DEVICE WAS REPLACED AND THE PROCEDURE          COMPLETED WITHOUT FILTER COMPLICATIONS.
THE INSTRUMENT WAS USEDDURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED IMMEDIATELY AFTER PERFORMING THE CHOLANGIOGRAM, WHILE INSERTING A 5MM LAPAROSCOPIC GRASPER INTO THE ANTERIOR AXILLARY 5MM TROCAR, THE TOP PORTION OF THE TROCAR SHEARED OFF FROM THE TROCAR SHAFT AT THE POINT WHERE THE BODY OF THE TROCAR AND THE SHAFT MEET. SINCE PART OF THE REMAINING SHAFT REMAINED IN THE ABDOMINAL WALL THE SURGEON WAS ABLE TO REMOVE IT, INSERTED A NEW 5MM TROCAR AND FINISH THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. THE OR STAFF REPORTS NO UNUSUAL TORQUING OF THE TROCAR PRIOR TO THE EVENT. THE TROCAR WAS FROM AN FTR22 KIT, LOT NUMBER J43W06.
NEGATIVE TROPONIN I RESULT WAS ERRONEOUSLY REPORTED AS POSITIVE. CARDIOLOGY PHYSICIAN REPORTED TO THE LAB THAT NO SIGNIFICANT CARDIAC EVENT HAD OCCURRED. TROPONIN I ANALYSIS REPEATED ON THESE SAMPLES AND CORRECTED VALUES WERE COMMUNICATED TO CLINICIANS.
THE DEVICE WAS USED DURING A LAP APPENDECTOMY. IT WAS REPORTED THE DEVICE WAS FIRED ACROSS THE APPENDIX. WHEN THE DEVICE WAS OPENED, IT WAS DISCOVERED THE DEVICE CUT, BUT DID NOT STAPLE. IT WAS REPORTED GANGRENOUS FLUID SPILLED OUT FROM THIS SITE. ANOTHER DEVICE WAS OPENED, FIRED, AND IT WORKED FINE. THE DEVICE WAS RELOADED WITH ANOTHER CARTRIDGE AND WAS FIRED. THE DEVICE STAPLED, BUT DID NOT CUT. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: NO ANALYSIS COULD BE PERFORMED SINCE NO INSTRUMENT WAS RECEIVED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THIS INCIDENT TO OCCUR.
DRIVE FAILURE WITH NO ALARM. F BLOCK: NOT USER FACILITY REPORTED.
FINAL ANALYSIS REVEALED DRIVE NUT WITH RUST AND CORROSION ON THE THREADED SEGMENT. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. SERIAL NUMBER PRE-DATES DRIVENUT MATERIAL CHANGE. DISCLAIMER: THIS REPORT MAY BE REQUIRED BY MEDICAL DEVICE REPORTING REGULATIONS CONTAINED IN 21 CFR SECTION 803. THESE REGULATIONS ARE VAGUE IN A NUMBER OF RESPECTS AND SUBJECT TO DIFFERENT INTERPRETATIONS. MOREOVER, THE REGULATIONS REQUIRE CO TO MAKE A DECISION ON REPORTING BEFORE HAVING COMPLETE INFORMATION, INCLUDING CO'S OWN ANALYSIS OF RETURNED PRODUCT. THUS CO'S DECISION TO FILE THIS REPORT SHOULD NOT BE LOOKED UPON AS ANYTHING OTHER THAN ITS TRANSMITTAL OF UNCONFIRMED FIELD INFORMATION WHICH THE FOOD AND DRUG ADMINISTRATION HAS REQUIRED MANUFACTURERS TO SUBMIT. CO BELIEVES THAT DISCLOSURE OF THE INFO REGARDING DEVICE EVAL COULD SUBSTANTIALLY HARM CO'S COMPETITIVE POSITION. CO SUBMITS THE INFO IN CONFIDENCE EXPECTING THAT THE FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF THE FREEDOM OF INFORMATION ACT. CO BELIEVES THAT ANY DISCLOSURE OF THE INFO BY A FEDERAL EMPLOYEE COULD CONSTITUTE A VIOLATION OF THE CRIMINAL LAW (18 U.S.C. SECTION 1905).
MD APPIED FIXATOR TO TREAT A DISTAL RADIUS FRACTURED. IT WAS SUBSEQUENTLY NOTED THAT THE PROXIMAL BALL JOINT AND DISTAL SCREW CLAMP HAD LOOSENED. THESE WERE RETIGHTENED IN THE MD'S OFFICE. THERE WAS NO INJURY TO THE PT.
THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH STRIPS. ON 8/6/96, SHE OPENED THE SECOND BOTTLE FROM A BOX OF FIFTY AND PERFORMED A NORMAL CONTROL TEST. THE RESULT WAS 9MG/DL. SHE IMMEDIATELY CALLED THE CUSTOMER SUPPORT LINE AND, WITH THE REP, PERFORMED TWO CONTROL TESTS. THE RESULTS WERE 11, AND 7MG/DL VERSUS A CONTROL RANGE OF 110-164 MG/DL. THE SOLUTION, ANOTHER BRAND, EXPIRATION 5/98, WAS OPENED ONE MONTH AGO AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. ALSO WITH THE REP, A CHECK STRIP TEST WAS PERFORMED AND THE RESULT WAS 82 VERSUS A RANGE OF 76-98. THE DESICCANT IS IN THE OPEN BOTTLE.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 8/22/96. ONE OPENED BOTTLE, CONTAINING 18 STRIPS WITH DESICCANT WAS RETURNED TO CO FOR EVAL. THE TEST RESULT OF THE NORMAL CONTROL SOLUTION READINGS OF THE CUSTOMER RETURNED BOTTLE CONFIRMED THE COMPLAINT OF LOW READINGS. FURTHER EVAL OF THE DESICCANT INSIDE THE RETURNED BOTTLE INDICATED THE FAILURE OF TEST STRIPS MAY HAVE BEEN DUE TO EXPOSURE TO MOISTURE. SOURCE OF THE EXPOSURE IS UNK. RETENTION SAMPLE TEST RESULTS MEET ALL SPECS FOR BLOOD GLUCOSE ACCURACY, PRECISION, AND NORMAL CONTROL SOLUTION RANGE. TREND ANALYSIS SHOWS THIS IS THE FIRST INACCURACY COMPLAINT FOR LOT. SINCE THE RETENTION SAMPLE TEST RESULTS DO NOT CONFIRM THE COMPLAINT OF LOW READINGS AND TREND ANALYSIS SHOWS THERE IS NO OTHER INACCURACY COMPLAINT, THIS PRODUCT FAILURE IS NOT LIKELY TO RECUR. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NO. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO.
EVALUATION SUMMARY: FINALY ANALYSIS REVEALED THAT THE DRIVE FAILED DUE TO RUSTED (STUCK) DRIVER ARM CAUSED BY EXPOSURE TO MOISTURE AND FUNCTIONAL TEST UNABLE TO BE PERFORMED. SERIAL NUMBER PRE-DATES DRIVENUT MATERIAL CHANGE.
MOTHER CALLED WITH COMPLAINT THAT DRIVER ARMS WERE ALMOST IMPOSSIBLE TO MOVE AND PUMP HAD NOT BEEN DROPPED, BUMPED OR EXPOSED TO MOISTURE.
THE PT REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH DEVICE, LOT 16149B. THE PT OPENED THE TEST STRIPS TODAY AND OBTAINED A NORMAL CONTROL SOLUTION TEST RESULT OF 160 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 105-157 MG/DL. WITH THE REPRESENTATIVE, THE PT OBTAINED THREE NORMAL CONTROL SOLUTION RESULTS OF 163, 155 AND 148 MG/DL. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE DESSICANT IS IN THE BOTTLE. THE PT SHOOK THE CONTROL SOLUTION BEFORE SHE APPLIED THE SAMPLE TO THE TEST PAD. THE PT COULD NOT READ THE LOT NUMBER AND EXPIRATION DATE OF THE CONTROL SOLUTION BECAUSE THE TYPESET WAS "TOO SMALL." HOWEVER, THE PT PURCHASED THE CONTROL SOLUTION THIS WEEK AND OPENED IT TODAY SO IT IS UNLIKELY THAT IT IS EXPIRED. SHE DID NOT HAVE A CHECK STRIP AVAILABLE TO TEST THE METER. THE PT STORES HER TEST STRIPS IN HER BEDROOM.
THE RETENTION SAMPLE TEST RESULT FOR LOT MET THE SPECIFICATIONS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. CO REQUESTED THAT THE PRODUCT BE RETURNED FOR EVALUATION ON 10/1/96. AS OF 10/30/96, RETURNED PRODUCT HAS NOT BEEN RECEIVED. NO FURTHER INVESTIGATION IS POSSIBLE. BASED ON THE EVALUATION OF RETENTION SAMPLES, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW . IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? U. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
THE DEVICES WERE USED DURING A LAPAROSCOPIC CHOLECYSTETOMY. THE CLIPS WERE SPITTING OUT OF THE DEVICE. A SECOND DEVICE WAS OPENED AND THE SAME THING HAPPENED. A THIRD DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. 10/3/96 IT WAS REPORTED THE CLIPS DID FALL INTO THE ABDOMEN, BUT WERE RETRIEVED WITHOUT DIFFICULTY.
CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS OF INSTRUMENT A HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. INSTRUMENT B WAS RETURNED WITH A DAMAGED FLOOR, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. NO CONCLUSION COULD BE REACHED AS TO HOW THE FLOOR HAD BECOME DAMAGED. INSTRUMENT B WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION. THE EXPERIENCE THE CUSTOMER REPORTED COULD NOT BE REPEATED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
WHILE CUTTING SOFT TISSUE, THE TIP ALLEGEDLY BROKE OFF DURING HAND SURGERY. THE TIP WAS ALLEGEDLY RETREIVED DURING THE HAND SURGERY.
CONTACT WITH THE USER FACILITY HAS NOT BEEN POSSIBLE, TO GET THE DEVICE RETURNED AND OBTAIN FURTHER INFO.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. IT WAS REPORTED BY THE REP INTRALUMINAL BLEEDING OCCURRED WHERE THE STAPLE LINE CROSSED WITH THE TLH30 STAPLE LINE (DISTAL RECTAL STUMP). THE ANASTOMOSIS WAS 2-3CM FROM THE ANAL VERGE. THERE WAS NO CONSEQUENCE TO THE PT. 10/21/96, BLEEDING WAS CONTROLLED BY APPLYING PRESSURE ON STAPLE LINE AT THE TRANSANAL FOR ABOUT FIVE MINUTES, AT WHICH TIME THE BLEEDING STOPPED.
D5,6;H3,4,6;G4: ADDED ADDITIONAL INFO. D6; DEVICE RETURNED WITH NO LOT ID. CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RELOADED AND FIRED. IT FIRED AND FORMED STAPLES AS DESIGNED AROUND THE ENTIRE STAPLE RING. THE STAPLE HEIGHTS WERE MEASURED AND FOUND TO BE CONFORMING WITH RESPECT TO MFG REQUIREMENTS. WITH THE INFO PROVIDED, IT COUL NOT BE ASCERTAINED AS TO HOW OR WHY THE BLEEDING REPORTEDLY OCCURRED. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
WITH A PT SUPINE ON THE TABLE, TABLE IN NORMAL ORIENTATION, THE LEG SECTION ROSE AND CONTINUED TO RISE UNTIL THE LEG SECTION WAS 90 DEGREES TO THE TABLE.
TECH EXAMINED THE TABLE ON 10/7/96. TABLE CHECKED OUT FINE AND WAS OPERATING WITHIN SPECS. FURTHER INVESTIGATION REVEALED THAT BOVIE CORD GOT CAUGHT UNDER LEG SECTION OVERRIDE SWITCH, CAUSING THE LEG SECTION TO INADVERTENTLY ARTICULATE UPWARD. OVERRIDE SWITCH COVER WAS IN PLACE, BUT ONE OF THE ATTACHING NUTS IS MISSING. RUBBER COATING ON SWITCH IS CRACKED, INDICATING IT WAS EITHER PINCHED BY THE COVER OR DAMAGED BY THE BOVIE CORD. THE PURPOSE OF THE COVER IS TO PREVENT ACCIDENTAL ACTIVATION OF OVERRIDE SWITCHES AND BROKEN COVERS SHOULD BE REPLACED. ACCORDING TO PERSONNEL AT HOSP, BOVIE CORD WAS VERY TIGHT UNDERNEATH TABLE. AFTER THE EVENT AND ONCE THE SITUATION HAD STABILIZED, OR PERSONNEL WENT TO USE THE BOVIE AND IT HAD UNPLUGGED ITSELF FROM THE WALL, INDICATING THAT THE CORD HAD BEEN PULLED. THE TABLE WAS REMOVED FROM SVC. THE TABLE IS MAINTAINED BY A 3RD PARTY SVC CO. PT SUSTAINED WHAT WAS DESCRIBED AS AN INJURY IN THE LATERAL COMPARTMENT OF THE LEFT (NON-SURGICAL) LEG. DR ICED LEG FOR 24 HRS. NEXT EXAM OF PT ON 10/6/96 REVEALED THAT AFTER TREATMENT PT COULD WALK WITHOUT PAIN. PT WAS DISCHARGED. OR NURSE SUSTAINED A PULLED CALF MUSCLE WHILE RUNNING TO PULL POWER CORD FROM WALL SOCKET. SHE IS ON CRUTCHES AND UNDERGOING THERAPY. THE DISTRICT SVC MGR HAS COMMUNICATED TO THE CUSTOMER THE CORRECT ACTION TO REPAIR THE TABLE. THE HOSP WAS INFORMED TO REMOVE TABLE FROM SVC UNTIL FOLLOWING REPAIRS TO TABLE WERE MADE. (1) THE HAND CONTROL BRACKET WAS VERY LOOSE, MUST BE REPAIRED, (2) POWER CORD EXTERIOER INSULATION WAS CUT, NO METAL WIRING WAS EXPOSED BUT ACORN NUT MISSING, MUST BE REPLACED, (4) CAP SHROUD HAD 3 SCREWS LOOSE OR MISSING, SHROUD CRACKED, MUST BE REPLACED. HOSP THIRD PARTY SVC GROUP TO PERFORM REPAIRS, THEY WERE GIVEN LIST OF REPLACEMENT PARTS TO ORDER, HOSP HAS BEEN INSTRUCTED NOT TO PUT TABLE BACK INTO SVC UNTIL REPAIRS ARE MADE.
THE DEVICE WAS USED DURING A COLON RESECTION. THE SURGEON CLAMPED/CLOSED ON LARGE COLON WITH WHITE HANDLE, FIRED WITH BLACK HANDLE. DURING THE FIRING THE JAWS OF THE DEVICE CAME OPEN AND ONLY A PARTIAL STAPLE LINE FORMED. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. 10/2/96 THE DISTAL (SUPERIOR) PART OF THE STAPLE LINE DID NOT FORM.
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
THE EXPIRATORY TUBE HAS POPPED OUT OF THE SEATING PORT. ACCORDING TO THE HOSP HAS OCCURRED EITHER WHEN THE VENTILATOR WAS ROLLED ACROSS THE ELEVATOR THRESHOLD, OR WHEN THE PT COUGHED WHILE CONNECTED TO THE VENTILATOR.
THE EXPIRATORY VALVE TUBE IS INCORRECTLY MOUNTED, WHICH IS DESCRIBED IN THE OPERATING MANUAL CHAPTER 7-10.
THE TIP OF THIS IRRIGATION/ASPIRATION HANDPIECE BROKE DURING A EYE PROCEDURE, ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE,
THE ANGLED TIP OF THIS DEVICE WAS BROKEN OFF. THE TIP COULD HAVE BEEN BUMPED OR HIT.
THE GASKET OF THIS DEVICE DISLODGED DURING PROCEDURE. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE. THE DEVICE IS NOT BEING RETURNED FOR CO'S ANALYSIS.
DEVICE HISTORY RECORDED REVIEW PERFORMED.
DURING A DIALYSIS TREATMENT, THERE WAS A DROP IN TMP (TRANS MEMBRANE PRESSURE). PT COMPLAINED OF NOT FEELING WELL. FOUND THAT PT HAD GAINED WEIGHT. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. CO TRACE NUMBER OF RETURNED COMPONENT/ASSEMBLY (WHEN APPLICABLE): NA. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS SPECIFIC SERIAL NUMBER MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/18/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED OL, INDICATING THAT THE FUSE WAS OPEN. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSED THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSED THE WAX TO MELT. FOLLOWUP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. FAILURE CODES: F CODE P004WR.CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
NURSE STARTED IV BUT NO PT BLOOD RETURN EVEN THOUGH NURSE FELT IT WAS IN THE VEIN. NURSE WITHREW NEEDLE AND BLOOD FLOWED BACK THROUGH HUB WHICH HAD 1/8 INCH LONG PIECE OF PLASTIC, LIKE THE CATHETER IN IT. IV DCED AND NURSE CHECKED THE REMAINDER OF THE DEVICE FOR DEFECTS AND LENGTH. NO OTHER DEFECTS NOTED AND LENGTH SAME AS NEW ONE.
AT THE BEGINNING OF EXAM, THE TABLE WAS IN THE UPRIGHT POSITION. DURING THE EXAM, THE TABLE WAS ANGLED DOWN THE HORIZONTAL POSITION. THE PT WAS THEN INSTRUCTED TO TURN ONTO HER RIGHT SIDE. AS THE PT WAS ATTEMPTING TO TURN UP ONTO HER RIGHT SIDE, THE TABLE ALLEGEDLY CRADLED TO THE LEFT AND THE TECHNOLOGIST RPORTEDLY HAD TO GRAB ONTO THE PT TO REPORTEDLY PREVENT HER FROM FALLING OFF THE TABLE ONTO THE FLOOR.
DURING A DIALYSIS TREATMENT, THERE WAS WEIGHT GAIN. THE PT UNDERWENT AN UNSCHEDULED TREATMENT.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND THE UF PUMP AND REPLACED. CO TRACE NUMBER OF RETURNED COMPONENT/ASSEMBLY (WHEN APPLICABLE): 860005000 AXJ1047. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THE SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS MACHINE WAS RELEASED TO THE FIELD. A SECONDARY RESEARCH OF THE DTF HISTORY FOR THIS PRODUCT REVEALS NO ADD'L DEFECTS. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE TECHNICIAN AT THE FACILITY FOUND THE UF (ULTRAFILTRATION) PUMP TO BE FAULTY. THE RETURNED UF PUMP WAS RECEIVED FOR ANALYSIS BY THE MFR ON 10/21/96. THE THERMAL FUSE WAS REMOVED FROM THE RETURNED UF PUMP. THE THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE OHM METER SHOWED 78.4 OHMS, INDICATING THE THERMAL FUSE IS BAD. THE THERMAL FUSE WAS DISASSEMBLED. IT WAS OBSERVED THAT THE WAX INSIDE THE FUSE HAD MELTED. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSED THE WAX TO MELT. FOLLOWUP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. FAILURE CODES: F CODE UFPMP004WR. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
PT RECEIVED, WHAT APPEARED TO BE 2 SETS OF 3 SKIN BURNS DUE TO DIRECT CONTACT WITH 3 SCREWS LOCATED ON A BUCKY.
SERVICE ENGINEER DISPATCHED TO REVIEW PROBLEM, DETERMINED THAT A WIRE WAS SHORTED TO THE FRAME. HOWEVER, THIS WAS ONLY 15 VOLTS D.C. CO IS UNSURE AT THIS TIME IF EQUIPMENT NOT MFG BY CO COULD HAVE BEEN IN USE ATTRIBUTING TO A HIGH POTENTIAL. CO IS CONTINUING TO INVESTIGATE.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. CO TRACE NUMBER OF RETURNED COMPONENT/ASSEMBLY (WHEN APPLICABLE): NA. A REVIEW OF DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS CIMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/23/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED 45.2 OHMS, INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSED THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSED THE WAX TO MELT. FOLLOWUP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #690016. FAILURE CODES: F CODE UPFMP004WR. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
DURING A ROUTINE CABG PROCEDURE THE T-CONNECTOR CRACKED ON A HEPARIN COATED AORTIC PERFUSION CANNULA. THE PT REQUIRED A BLOOD TRANSFUSION.
PT STATED TUBING WAS LEAKING AT THE FILTER. TUBING CHECKED BY RN ON 10/25/96 AND LEAK WAS NOTED AT TOP OF FILTER. PT INSTRUCTED TO NOTIFY NURSE IF FURTHER PROBLEMS WITH TUBING BUT IN THE FUTURE IF SUCH PROBLEMS OCCUR PT SHOULD CHANGE TUBING AND RESUME INFUSION RATHER THAN MISS A TREATMENT. EVENT OCCURRED 10/24 BUT SHE DID NOT NOTIFY HOME HEALTH UNTIL 10/25/96.
UPON OPENING THE STERILE TRAY THE STOPCOCK SEPARATED FROM THE INFLATION LINE. THE PT WAS NOT INVOLVED.
A GRADUATE NURSE SUSTAINED A NEEDLESTICK WHILE INSERTING THE IV CATHETER DEVICE INTO A COMBATIVE PT. THE NURSE STATED THAT HE THOUGHT HE HAD HEARD THE DEVICE LOCK, BUT WAS IN A HURRY. WHEN HE LATER PICKED UP THE DEVICE WITH HIS RIGHT HAND, HE SUSTAINED A NEEDLESTICK TO HIS LEFT THUMB. TREATMENT INCLUDED PRIMARY FIRST AIDE AND BLOOD DRAWS FOR TITERS. THE DEVICE WAS DISCARDED BY THE NURSE. THE FACILITY CONTACT BELIEVES THAT THE FACT THAT THE DEVICE WAS NOT LOCKED WAS POSSIBLY RELATED TO USER ERROR.
DATE SENT TO FDA: 10/25/96. CLARIFICATION FOR SECTION H6 METHODS CODE, METHOD: 86 FORCE TO ADVANCE AND FORCE TO LOCK TESTING; RESULTS CODE, RESULTS: 300 THE RETAIN PRODUCT TESTED MET THE SPECIFICATIONS FOR FORCE TO ADVANCE AND FORCE TO LOCK. THE FACILITY WAS OFFERED ADD'L TRAINING FOR THE NURSE, BUT THIS WAS REFUSED IN FAVOR OF INTERNAL TRAINING.
DURING COMPOUNDING OF TPN, THE PLASTIC PVC TUBING PULLED OUT OF ITS ATTACHMENT INTO THE RED PLASTIC PART WHICH CONNECTS THE TUBING TO THE PUMP SEGMENT.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP. FAILED TO FIRE. THERE WAS NO CONSEQUENCE TO THE PT. THE BLACK INSULATION SLEEVE SLIPPED APPROXIMATELY 1 CM DOWN THE SHAFT.
A1,2,3,4;B3,6,7;D10: CONTACTED FACILITY, INFORMATION NOT PROVIDED. D5,6;H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. H6; EVALUATION CODE #400(OTHER): DAMAGED FIRING MECHANISM.
DURING A DIALYSIS TREATMENT, THERE WAS WEIGHT GAIN. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. CO TRACE NUMBER OF RETURNED COMPONENT/ASSEMBLY (WHEN APPLICABLE): NA. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT THERE WAS ONE OTHER INCIDENT (CPF 1096220C3) CAUSED BY THE SAME FAILURE INVESTIGATED IN THIS REPORT. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDS: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/28/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED 410 OHMS, INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSED THE FUSE TO OPEN. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS. WHEN THE PUMP COOLS DOWN, THE FUSE BECOMES OPERATIONAL AGAIN. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT  TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. FOLLOWUP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. FAILURE CODES: F CODE UFPMP004WR. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
A LARGE COMPRESSION PADDLE WAS IN PLACE ON UNIT WITH A LARGE BUCKY CASSETTE. IN POSITIONING THE PT ON THE UNIT, THE COMPRESSION PADDLE ALLEGEDLY FREE FELL FROM ITS UPPERMOST POSITION ON TO THE PT'S BREAST, ALLEGEDLY PINCHING THE PT'S BREAST NIPPLE BETWEEN THE BUCKY DEVICE AND THE COMPRESSION PADDLE REPORTEDLY CAUSING A BLOOD BLISTER AND BLEEDING AT NIPPLE.
ON 10/30/96 PT WAS BEING TREATED BY HER SISTER IN APPLYING A RX LOTION TO OPEN WOUNDS ON HER SCALP. WHEN HER SISTER WENT TO REACH INTO THE GLOVE BOX, SHE PULLED OUT A GLOVE THAT APPEARED TO HAVE CAKED BLOOD ON IT. THIS UPSET BOTH LADIES VERY MUCH. THEY RETURNED THE OPEN BOX OF GLOVES TO RPTR WERE THEY PURCHASED IT. RPTR LOOKED AT THE GLOVE AND THE MATERIAL ON IT. IT LOOKED LIKE CAKED BLOOD.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO TUBING BREAK.
AFTER INJECTING A PT WITH A HEP B VACCINE, THE NURSE DISPOSED OF THE NEEDLE ATTACHED TO THE SYRINGE IN A WALL-MOUNTED BIOHAZARD CONTAINER. WHEN THE NURSE PLACED THE EMPTY VACCINE VIAL IN THE CONTAINER, THE NEEDLE PIERCED THE NURSE'S R+ INDEX FINGER. THE SYRINGE HAD LANDED STRAIGHT UP IN THE CONTAINER AND WAS STICKING THROUGH A SMALL HOLE IN THE CONTAINER. THE CONTAINER'S DESIGN SHOULD BE MODIFIED TO NOT ALLOW NEEDLES TO POKE THROUGH HOLE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS, PAIN-SCROTUM, AND CLOUDY YELLOW FLUID FOUND NEAR RESERVOIR. ADD'L LOT/SER NO: 1057L 006.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD A WEAR LEAK. CYLINDER HAD OR DAMAGE. TUBING WAS FUNCTIONAL.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE A 3.75 X 15 SELF-TAPPING IMPLANT, RATHER THAN THE REPORTED MODEL SELF-TAPPING IMPLANT. IT IS POSSIBLE THAT THE PT'S ALLERGY TO PENICILLIN WAS A CONTRIBUTING FACTOR, ALTHOUGH CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
FOUR REAMERS WERE RETURNED BROKEN AT THE WELD.
WELD SPEC HAS BEEN CHANGED TO IMPROVE WELD QUALITY.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A FAILED PROSTHESIS.
MFR'S RESPONSE RECEIVED ON 2/13/97: THE FUNCTIONALITY OF SYRINGES WITH THIS CONDITION HAVE NOT BEEN FOUND TO BE COMPROMISED. BASED UPON AN INITIAL EVALUATION AND SUBSEQUENT INCIDENT SPECIFIC EVALUATIONS THIS CONDITION DOES NOT COMPROMISE VOLUMETRIC ACCURACY WHICH IS REQUIRED BY INTL STANDARDS (ISO) TO BE WITHIN +/- 5%. IT APPEARS THAT THE CAUSE OF THIS UNACCEPTABLE AESTHETIC CONDITION WAS ATTRIBUTED TO AN UNFORESEEABLE COMBINATION OF CONDITIONS, INCLUDING: SLIGHT MISALIGNMENT DURING THE ASSEMBLY OF THE PLUNGER ROD/STOPPER INTO THE SYRINGE BARREL, DISTRIBUTION (AS OPPOSED TO QUANTITY) OF MEDICAL GRADE LUBRICATION (A COMPONENT IN ALL DISPOSABLE SYRINGES) WITHIN THE BARREL, AND THE SENSITIVITY OF THE NEW STOPPER DESIGN TO THESE CONDITIONS. CO'S MFG FACILITY IS IN THE PROCESS OF CLARIFYING THE SPECIFICS OF THESE ROOT CAUSES AND DEVELOPING CORRECTIVE ACTIONS FOR THIS CONDITION.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE ONE CYLINDER WOULD NOT INFLATE.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD TORN FABRIC AND BULGING. TUBING HAD OR DAMAGE.
THE REPORTER FROM RISK MANAGEMENT CONFIRMED THAT THIS EVENT WAS RELATED TO USER ERROR AND THAT IN HOUSE TESTING DID NOT FIND A PUMP PROBLEM. FOR THESE REASONS THE PUMP IS BACK IN SERVICE AND WILL NOT BE RETURNED TO THE MFR FOR EVAL. SECTION F COMPLETED BY CO PER INFO PROVIDED IN MEDWATCH REPORT ATTACHED.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION -SCROTUM.
DURING A ROUTINE CABG PROCEDURE, THE T-CONNECTOR CRACKED ON A HEPARIN COATED AORTIC PERFUSION CANNULA. THE PT REQUIRED A BLOOD TRANSFUSION.
A PENILE PROSTHESIS WAS IMPLANTED, DATE AND PRODUCT TYPE NOT INDICATED. ON 7/1/96 THE ENTIRE DEVICE WAS REMOVED AND REPLACED, REASON NOT INDICATED. SURGERY INFO HAS NOT BEEN PROVIDED AT THIS TIME.
TUBING BROKE AT POINT OF CONNECTION TO FILTER PRIOR TO HOOKUP.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD A FATIGUE LEAK. CYLINDER WAS FUNCTIONAL. CYLINDER HAD OR DAMAGE. TUBING HAD OR DAMAGE.
PRIOR TO USE THE MD INSERTED A HOSP DESIGNED OBTURATOR INTO THE CANNULA. THE CONNECTOR CRACKED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS -RESERVOIR.
TUBING WAS FUNCTIONAL. PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. CYLINDER HAD TORN FABRIC AND BULGING.
DEVICE WAS REMOVED FROM THE PT, DUE TO A "DEFECT" MAL ROTATION TO ONE SIDE, AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK. CYLINDER HAD TORN FABRIC AND BULGING.
ADDITIONAL INFORMATION RECEIVED ON 2/14/97 INDICATES FLUID LOSS.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS LEAK AT RESERVOIR TUBE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER NO: BI926 008.
DURING A CATARACT EXTRACTION PROCEDURE, PARTICULATE CAME FROM THIS HANDPIECE AND ENTERED THE PATIENT'S EYE.  ALL PARTICULATE WAS ABLE TO BE ASPIRATED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MANUFACTURER. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. A FILTER TEST WAS PERFORMED ON THIS HANDPIECE. NO PARTICLES WERE FOUND.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -RIGHT CYLINDER.
ON 9/19/90 DEVICE WAS IMPLANTED. ON 11/20/92 THE RIGHT CYLINDER WAS REVISED. ON 11/24/92 THE CYLINDERS WERE REVISED. ON 10/01/96 THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PAIN AND INFECTION POSSIBLE SCROTUM.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. TUBING HAD OR DAMAGE.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATIONS DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." METHOD CODE #86 OTHER= DEVICE HISTORY REVIEWED. RESULTS CODE # 100 OTHER=DEVICE HISTORY REVIEW FOUND THAT THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR CLINICAL USE. INITIAL REPORT WAS RECEIVED BY PHONE ON 10/1/96. A MEDWATCH FORM WAS REQUESTED FROM THE USER FACILITY AT THAT TIME AND RECEIVED FROM THE USER FACILITY ON 10/25/96. SOME INFO REQUIRED FROM THE USER FACILITY WAS OMITTED THEREFORE, THE MISSING INFO ON THIS MEDWATCH FORM 3500A WAS COMPLETED BY CO WITH INFO RECEIVED FROM THE HEALTHCARE PROFESSIONAL. " ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, MEDTRONIC IS UNABLE TO COMPLETE FORM 3500A." H3 ANALYSIS: TO DATE NO PRODUCT HAS BEEN RETURNED FOR ANALYSIS, THEREFORE, NO CONCLUSION CAN BE DRAWN. HOWEVER, THE DEVICE HISTORY SHOWS THAT THE PRODUCT MET SPECIFICATION PRIOR TO RELEASE FOR CLINICAL USE, AND THE HEALTHCARE PROFESSIONAL REPORTED THAT THE LIKELY CAUSE OF THE INTERMITTENT IMPINGEMENT WAS TISSUE ENTRAPMENT AS A RESULT OF THE SURGICAL PROCEDURE.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION AND URETHRAL EROSION.
CORD CLAMP APPLIED AND CUT BY DR. TEN MINS LATER, IT WAS NOTICED THAT CORD CLAMP WAS OFF AND BLOOD WAS SLOWLY OOZING FROM CORD. NEW CLAMP APPLIED. CLAMP WAS FOUND CLOSED. IT APPARENTLY SLIPPED OFF. WEIGHT 7LB 8 OZ.
ON 1/7/93 AN AS DEVICE WAS IMPLANTED. ON 11/19/93 THE CUFF WAS REVISED. ON 10/1/96 THE CUFF WAS REMOVED FROM THE PT DUE TO EROSION.
A REVISION SURGERY WAS PERFORMED DUE TO EROSION AT LEFT CYLINDER. NO COMPONENTS WERE REMOVED OR REPLACED.
PT EXPERIENCED PAIN. X-RAYS REVEALED DEVICE HAD FRACTURED.
CATALOG #00-1131-002-32 LAG SCREW LOT #59638400. CATALOG #00-0318-002-00 PARHAM BANDS LOT #75553500. COMPRESSION SCREW & 9 BONE SCREWS, PART # & LOT #UNK EVALUATION CODES FOR SECTION H6:100-68, 100- THE DEVICE WAS EXAMINED IN THE RESEARCH LABORATORY, SEM INDICATES FATIGUE STRIATIONS AND THE EDS IS CONSISTANT WITH 316LSST AS REQUIRED. 68- FATIGUE STRIATIONS WERE OBSERVED ON THE FRACTURE SURFACE INDICATING THIS FRACTURE OCCURRED DUE TO METAL FATIGUE. SECTION F WAS COMPLETED BY THE MFR. INFO WAS REC'D THROUGH A CONSUMER. THE USER FACILITY HAS BEEN CONTACTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME.
ON 6/29/95,AN AUS DEVICE WAS IMPLANTED. ON 9/16/96 AN TANDEM CUFF WAS IMPLANTED. ON 9/23/96 A SINGLE CUFF WAS REMOVED FROM THE PT AND REPLACED WITH A LARGER CUFF DUE TO URINARY RETENTION.
DEVICE WAS REMOVED FROM THE PT DUE TO A FLUID LOSS FROM THE RIGHT CYLINDER. ANOTHER DEVICE WAS IMPLANTED.
THE CORD CLAMP FROM THE L&D PACK WAS PLACED ON THE UMBILICAL CORD. THE CORD WAS CUT APPROPRIATELY. THE CLAMP CAME OFF THE CORD AND CAUSED THE BABY TO BLEED FROM THE UMBILICAL CORD. INCIDENT WAS IMMEDIATELY A NEW CLAMP WAS PLACED AND CLAMPED ON THE CORD.
A MES (MEDICAL EQUIPMENT SERVICE) TECH EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT THERE WAS ONE OTHER INCIDENT (CPF 1096221C3) CAUSED BY THE SAME FAILURE INVESTIGATED IN THIS REPORT. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/28/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED 410 OHMS, INDICATING THAT THE FUSE WAS BAD. THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS. WHEN THE PUMP COOLS DOWN, THE FUSE BECOMES OPERATIONAL AGAIN. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. FOLLOW-UP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016.FAILURE CODES: F.CODE UFPMP004WR. CUSTOMER CONTACTED? N. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
X-RAYS REVEALED THE DEVICE HAD FRACTURED AND THE PROXIMAL END WAS LOOSE. DEVICE WAS REMOVED AND REPLACED.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "N", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "N", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNK OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO RUPTURE.
CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A FATIGUE LEAK.
ON 10/20/87 AN AUS DEVICE WAS IMPLANTED. ON 11/29/88 THE BALLOON WAS REVISED. ON 3/1/89 THE CUFF WAS REVISED. ON 9/25/96 THE CUFF WAS REMOVED DUE TO URETHRAL EROSION.
AN AUS DEVICE WAS IMPLANTED, DATE NOT INDICATED. THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. SURGERY INFO HAS NOT BEEN PROVIDED AT THIS TIME.
DEVICE FRACTURED REQUIRING REVISION SURGERY.
SECTION F WAS COMPLETED BY THE MFR. THE USER FACILITY HAS BEEN CONTACTED. NO INFO AVAILABLE AT THIS TIME.
ON 9/23/85 AN AUS DEVICE WAS IMPLANTED. ON 8/9/85 A CONNECTOR WAS REVISED. ON 12/8/96 THE BALLOON AND PUMP WERE REVISED AND A TANDEM CUFF WAS ADDED. THE EXISTING CUFF WAS PLUGGED OFF AT THIS TIME. ON 9/17/96 THE EXISTING 7.0 CUFF WAS PLUGGED EARLIER IS UNPLUGGED AND RECONNECTING AT THIS TIME.
NO COMPONENTS WERE REMOVED OR REPLACED AT THIS TIME.
DURING A CATARACT EXTRACTION PROCEDURE, PARTICULATE CAME FROM THIS HANDPIECE AND ENTERED THE PATIENT'S EYE. ALL PARTICULATE WAS ABLE TO BE ASPIRATED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION DIFFICULTY PUMPING.
CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. PUMP PERFORMED WITHIN SPECS.
PLASTIC LINER SEPARATED FROM METAL SHELL REQUIRING SURGERY TO REMOVE AND REPLACE.
SECTION F WAS COMPLETED BY THE MFR. INFO RECEIVED WAS THROUGH A FOREIGN SOURCE WHICH ARE NOT OBLIGATED TO COMPLETE FORM 3500A. NO ADDITIONAL INFO ON THE USER FACILITY OR THE HEALTH PROFESSIONAL IS AVAILABLE AT THIS TIME.
INFO RECEIVED ON 1/13/97 INDICATES THE AUS DEVICE WAS REMOVED FROM THE PT IN MARCH, 1996, REASON AND DAY NOT INDICATED. UNABLE TO OBTAIN ADD'L INFO.
ON WHEELCHAIRS THAT HAVE A "BREAKAWAY" FOOTREST FEATURE THERE IS A METAL SUPPORT THAT PROTRUDES OUT TOWARDS THE PT'S LEG AS THEY ARE SEATED. THIS EVENT WHERE THE PT WAS BRUISED AND/OR LACERATED IS NOT AN ISOLATED ICIDENT. LONG-TERM CARE FACILITIES USE WHEELCHAIRS FOR A LARGE PERCENTAGE OF THEIR POPULATION.
A PENILE PROSTHESIS WAS IMPLANTED, DATE AND TYPE OF DEVICE NOT INDICATED. ON 8/15/96 THE ENTIRE DEVICE WAS REMOVED AND REPLACED DUE TO EROSION.
A REVISION SURGERY DUE TO RECURRING INCONTINENCE WAS ATTEMPTED BUT CANCELLED.
RESPONSE TO REQUEST: IN REGARD TO THE DEVICE INVOLVED IN THIS INCIDENT, NO DEFECT HAS BEEN IDENTIFIED. THE BASIS OF THIS REPORT IS THE BIOMEDICAL MGRS' OPINION THAT THIS DESIGN NEEDS TO FULLY PROTECT THE PT IN ALL POSSIBLE SITUATIONS. THEREFORE, ANALYSIS IS NOT BASED ON THE ACTUAL WHEELCHAIR INVOLVED, BUT RATHER THIS DESIGN FEATURE. APART FROM THE SAFETY STANDARDS USED WHEN THIS DEVICE WAS FIRST DESIGNED, CO'S RECORDS SHOW THIS TO BE THE FIRST NOTIFICATION OF AN INCIDENT SUCH AS THIS AND THE OUTCOME HAS NOT RESULTED IN A SERIOUS INJURY. IT SHOULD BE CONSIDERED THAT THIS DESIGN HAS BEEN MARKETED SINCE 1980 AND CO CURRENTLY PRODUCE OVER 5,000 PER YEAR. THIS DESIGN FEATURE IS USED THROUGHOUT THE INDUSTRY. SPECIFIC TO INVACARE, THIS DESIGN HAS BEEN IN USE FOR OVER 16 YEARS WITHOUT REPORT OF SERIOUS INJURY AND NO DEFECT HAS BEEN IDENTIFIED IN THIS CASE. CONCLUSION IS THAT THIS DESIGN DOES NOT REPRESENT A SIGNIFICANT RISK TO PUBLIC HEALTH OR SAFETY. THEREFORE, CO BELIEVES NO FURTHER ACTION IS NECESSARY AND CONSIDER THIS ISSUE RESOLVED.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT, DUE TO FLUID LOSS-RIGHT CYLINDER, AND REPLACED.
ON 9/7/94 AN AUS DEVICE WAS IMPLANTED. ON 7/20/96 THE CUFF WAS REVISED. ON 8/28/96 THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
ON 10/16/85 AN AUS DEVICE WAS IMPLANTED. ON 3/5/86 THE BALLOON AND CUFF WERE REVISED. ON  9/25/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION -BLADDER NECK.
THE SWITCH EMITTED SPARKS. INSPECTION REVEALED A BREAK IN THE CORD LINE AT THE STRAIN RELIEF. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. COMPANY HAS ADDED A CAUTION TO THE LABELLING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
THE DEVICE WAS REMOVED FROM THE PT DUE TO PERFORATION THROUGH THE GLANS. ADD'L LOT/SER# BU797 005.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDERS PERFORMED WITHIN SPECIFICATIONS.
ON 5/10/85 PENILE IMPLANT DEVICE WAS IMPLANTED. ON 11/15/89 THE CYLINDERS WERE REVISED. ON 9/10/96 THE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION.
PT BEING TREATED FOR VENUS ULCERS LT LEG. WOUNDS PROGRESSING BUT HAD SLOWED. ON 10/1/96, NURSE APPLIED NEW PRIMARY DRESSING. ON RETURN VISIT ON 10/4 WOUND FOUND WITH COPIOUS AMOUNTS OF PURULENT DRAINAGE, INCREASED WOUND SIZE AND PAIN AT SITE. WOUND C & S DONE. PT'S WOUND CARE CHANGED TO BID, NORMAL SALINE WET TO DRY. MD NOTIFIED. PT STARTED ON PER ANTIBIOTICS. MFR NOTIFIED OF PROBLEM. MD SAW PT ON 10/8/96 FOR WOUND DEBRIDEMENT. THE END RESULT WAS A DIAGNOSIS OF POSSIBLE CHEMICAL REACTION. LOWER LEG WITH PEELING, SLOUGHING SKIN, IN ADDITION TO THE INFECTION.
ON 4/18/88 AN IPP DEVICE WAS IMPLANTED. ON 8/21/96, THE PUMP WAS REVISED. ON 10/16/96, THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FAILURE--DISLODGED CONNECTOR.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CONNECTOR WAS NOT FUNCTIONALLY TESTED.
THE BALLOON AND CUFF WERE REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
ON 12/16/94 AN AUS DEVICE WAS IMPLANTED. ON 5/3/95 THE BALLOON WAS REVISED. ON 3/15/96 THE CUFF AND BALLOON WERE REVISED. ON 9/25/96 A TANDEM CUFF WAS IMPLANTED DUE TO RECURRING INCONTINENCE. NO COMPONENTS WERE REMOVED OR REPLACED.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO A BREAK IN THE TUBING AND AGE OF THE CYLINDERS.
THE SWITCH EMITTED FIRE. THE UNIT HAS NOT BEEN RETURNED TO CO. FOR INSPECTION. THE USER DISCARDED THE UNIT. NO DEATH OR SERIOUS INJURIES WERE REPORTED. THE USER INDICATED THE UNIT WAS OVER TWENTY YEARS OLD. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE--PUMP WOULD NOT RE-EXPAND.
LTH IMPLANTED 9/3/92. REVISED 8/8/96, DUE TO FAILURE AND FRAGMENTATION OF POLY LINER.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS RESERVOIR TUBING. ADD'L LOT/SER NO: 0637T 009.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -CCLUSIVE CUFF, SMALL CUFF LEAK OCCURRING AT ONE OF THE CREASES WITHIN THE CUFDF AND SMALL RESERVOIR CAPACITY SECONDARY TO FIBROTIC CAPSULE.
REPLACEMENT OF KINKED TRACHEOSTOMY TUBE WAS UNSUCCESSFUL. SEMI-ELECTIVE INTUBATION PERFORMED. IMMEDIATE HYPERINFLATION OF LUNGS WITH PROBABLE BILATERAL PNEUMOTHORACES SECONDARY TO FAILED EXHALATION VALVE ON VENTILATION BAG. EXHAUSTIVE DIFFERENTIAL DIAGNOSIS PURSUED. BILATERAL CHEST TUBE PLACED. CPR INITIALLY UNSUCCESSFUL. RT REPORTS IMPROVED VENTILATION SPONTANEOUSLY. HEMODYNAMICAL RECOVERY BUT BRAIN DEATH PRESENT. SUPPORT WITHDRAWN 10/10/96. EXTREMELY SUSPICIOUS OF FAULTY EXHALATION VALVE ON VENTILATION BAG. AUTOPSY CONFIRMS NO ANATOMICAL EXPLANATION. CABG X 3 ON 9/11/96 COMPLICATED BY LATE NON-OCCLUSIVE MESENTERIC ISCHEMIA. COMPLETE RECOVERY FROM THIS CONDITION WAS EXPECTED.
THE BALLOON AND CUFF WERE REMOVED FROM THE PT AND REPLACED BECAUSE THE SPHINCTER WAS LEAKING.
DEVICE WAS IMPLANTED, DATE WAS NOT INDICATED. ON 9/24/96, THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. CO HAS REQUESTED ADD'L INFO.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLIDER WAS FUNCTIONAL. CYLINDER HAD A WEAR LEAK. TUBING WAS FUNCTIONAL.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACTION AUTO INFLATION.
ON 2/27/89 AN AUS DEVICE WAS IMPLANTED. ON 11/8/89 THE PUMP WAS REVISED. ON 9/26/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE-FLUID LOSS.
A PT RECEIVED HER FIRST TREATMENT ON 9/19/96 IN THE NASOLABIAL FOLDS AND VERMILION BORDERS. ON 10/29/96, THE PT NOTED REDNESS, SWELLING, AND INDURATION AT THE TREATMENT SITES. ON 10/30/96, SHE PRESENTED WITH PERSISTENT SYMPTOMS AT THE TREATMENT SITES. THE PHYSICIAN WAS UNSURE IF THE SYMPTOMS REPRESENTED A HYPERSENSITIVITY; ORAL CEFTIN WAS PRESCRIBED.
ON 13 NOVEMBER 1997, FOLLOW UP WAS REC'D FROM THE PHYSICIAN. THE PT WAS LAST SEEN ON 03 NOVEMBER 1997. THE SYMPTOMS RESOLVED '6 WEEKS POST'. THERE WERE NO RESIDUAL PROBLEMS WITH HYPERSENSITIVITY.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO NON-DEFLATING PROSTHESIS. ADD'L LOT/SER# 5946J 008.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO PENILE CURVATURE AND AUTO INFLATION. ADD'L LOT/SER NO AT565 008.
THE CUFF AND BALLOON WERE REMOVED FROM THE PT, DUE TO RECURRING INCONTINENCE, AND REPLACED.
THE COIL BROKE IN THE CATHETER BEFORE IT WAS CONNECTED TO THE POWER SUPPLY. PART OF THE COIL WAS IN THE PT, BUT ALL PIECES WERE REMOVED AND THE PROCEDURE COMPLETED WITH OTHER DEVICES. THE PT WAS OK. THERE HAD BEEN NO TROUBLE ADVANCING THE COIL DURING DEPLOYMENT.
THE DEVICE WAS RETURNED TO CO AND ANALYZED FOR FAILURE MODE. EXAM OF THE DEVICE FOUND THE PUSHER SECTION OF THE DEVICE WAS RETURNED WRAPPED AROUND ITSELF INSIDE AN OPENED POUCH, THE COIL WAS RETURNED WRAPPED IN A PIECE OF GAUZE. THE PROXIMAL END OF THE COIL IS BADLY STRETCHED. THE COIL ON THE DISTAL END OF THE MAIN SOLDER JOINT. FROM THE CONDITION OF THE DEVICE, IT WOULD APPEAR THE MAIN COIL BECAME STUCK SOMEWHERE IN THE MIDDLE SECTION, AND WHILE ATTEMPTING TO REMOVE THE COIL IT STRETCHED AND BROKE. THE DR REPORTED THAT PART OF THE COIL WAS IN THE CATHETER AND THAT THE COIL WAS ABLE TO BE RETRIEVED. IT WOULD APPEAR THAT OVER MANIPULATION OF THE DEVICE CAUSED IT TO BREAK. FREQUENCY AND SEVERITY OF OCCURRENCE OF THIS EVENT ARE NOT ADDRESSED IN THE LABELING. THE REPORTED EVENT IS NOT OCCURRING WITH GREATER THAN EXPECTED FREQUENCY. THE REPORTED EVENT IS NOT OCCURRING WITH GREATER THAN EXPECTED SEVERITY. THIS INFO IS BASED ON INFO SUPPLIED TO CO WITHOUT CO'S INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED BECAUSE IT WOULD NOT INFLATE.
INFO FOUND IN SECTION F WAS TRANSFERRED DIRECTLY FROM A MEDWATCH REPORT RECEIVED FROM THE USER FACILITY. THE REPORTED EVENT COULD NOT BE DUPLICATED. FREQUENCY OF OCCURRENCE OF CODE 102 (OVERDELIVERY) DEATH OR SERIOUS INJURY IS APPROX 0.21/MILLION SETS.
FLOW RATE OF CARDIOPLEGIA SOLUTION FROM GLASS BOTTLE WAS IMPEDED BY SPIKE ADAPTER DURING CARDIAC SURGERY. MULTIPLE ADAPTERS WERE USED. THE PT WAS IN VENTRICULAR TACHYCARDIA, WHICH WAS MANAGED ONCE AN ADAPTER ALLOWED ADEQUATE RATE OF FLOW. THE PT RECOVERED FROM SURGERY WITHOUT APPARENT SEQUELAE.
SECTION F COMPLETED BY CO BASED ON INFO RECEIVED FROM THE REPORTER. EVALUATION: THE CUSTOMER RETURNED ONE USED VENTED SPIKE ADAPTER WHICH MAY OR MAY NOT HAVE BEEN THE ACTUAL UNIT INVOLVED IN THIS INCIDENT (SINCE REPORTER SAID THIS WAS TAKEN OUT OF THE TRASH BAG). SPIKE WAS INSPECTED AND NOTED THE STELL BALL IN THE AIRWAY WAS FREELY MOVING. THE SPIKE WAS ATTACHED TO A BAG OF STERILE WATER AND THE FLOW FOR ONE MINUTE WAS 214 ML. THE ADAPTER WAS SPIKED TO A GLASS BOTTLE OF INTRALIPID 10% FAT EMULSION AND THE FLOW APPEARED TO BE SATISFACTORY.
INFO RECEIVED ON 1/13/97 INDICATES THE RESERVOIR WAS NOT REMOVED FROM THE PT.
RPTR C/O ILLNESS, HAIR LOSS, VERTIGO, FIBROMYALGIA, FATIGUE, SHAKINESS, WEAKNESS, SHORT-TERM MEMORY LOSS, CANKER SORES, RASHES, PTOSIS OF LEFT EYE, DRY EYE SYNDROME, "DIPLOPIA OF RIGHT EYE", SWOLLEN LEGS, HANDS, FINGERS AND LYMPH NODES, JOINT PAIN, LUMP IN THROAT, ROUGH MOUTH, EYE AND TEMPLE PAIN, NUMBNESS AND TINGLING IN ARMS, LEGS, HANDS, FEET, AND AROUND MOUTH, AND DISABLILITY SINCE 1988 AFTER HAVING SILICONE IMPLANTS REPLACED ON 2/11/87. LEFT BREAST IMPLANT DIAGNOSED WITH INTRACAPSULAR RUPTURE BY MRI ON 12/5/95. MULTIPLE LYMPHNODES CONTAIN SILICONE. CBC SHOWED POIKILOCYTOSIS AND ANISOCYTOSIS. IMPLANTS REMOVED 11/27/96.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -BALLOON.
THE IPP DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER NO: BZ363 009.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE  WENT DEAD.  ANOTHER HANDPIECE WAS USED TO SUCCESSFULLY COMPLETE THEPROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.  THIS HANDPIECE APPEARS TO HAVE BEEN REWORKED BY AN OUTSIDE VENDOR. IT HAS A LARGER GAUGE CABLE, DIFFERENT STRAIN RELIEF, DIFFERENT FINISH ON THE HANDPIECE AND A DIFFERENT JOINT ON THE NOSE.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE BALLOON COMPLETELY UNFOLDED. THE SHEATH TUBING WAS NOTED TO BE KINKED IN SEVERAL LOCATIONS. BLOOD WAS OBSERVED ON THE BALLOON'S EXTERIOR AND WITHIN THE INNER LUMEN. IN ADDITION, THE EXTRACORPOREAL TUBING WAS NOTED TO BE ABSENT FROM THE Y-FITTING. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE RETURNED PORTION OF THE IAB. AFTER A LABORATORY EXTRACORPOREAL TUBING WAS ATTACHED TO THE Y-FITTING, THE IAB PUMPED SATISFACTORILY ON THE LABORATORY SYSTEM 90 IABP AT 80 AND 160 BPM. NO ALARMS SOUNDED DURING THE TEST. PROBABLE CAUSE OF DIFFICULTY: NO LEAK WAS FOUND IN THE RETURNED PORTION OF THE IAB TO HAVE CAUSED THE REPORTED LEAK ALARMS. IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED DIFFICULTY BASED ON THE EVENT DESCRIPTION AND EXAMINATION. IN GENERAL, EXCESSIVE ALARMS MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: A TEMPORARY KINK IN THE CATHETER TUBING MAY HAVE PREVENTED THE FLOW OF HELIUM INTO AND OUT OF THE BALLOON MEMBRANE CAUSING THE PUMP TO SENSE A "LOSS" OF GAS OR TO DISPLAY "CATHETER FAULT". MANIPULATION OF THE BALLOON CATHETER MAY HAVE ALLEVIATED THE PROBLEM. THE BALLOON MEMBRANE DID NOT FULLY EXIT THE SHEATH, THUS NOT ALLOWING THE MEMBRANE TO FULLY INFLATE. THE CATHETER TUBING MAY HAVE BECOME KINKED IF THE IAB WAS NOT REMOVED FROM THE TRAY RETAINERS ACCORDING TO DATASCOPE'S INSTRUCTIONS FOR USE. THERE WAS A LOOSE CONNECTION BETWEEN THE IAB AND THE PUMP OR BETWEEN THE PUMP AND THE SAFETY CHAMBER. CHECKING THESE CONNECTIONS MAY HAVE ALLEVIATED THE PROBLEM. THERE MAY HAVE BEEN A LEAK IN THE UNRETURNED EXTRACORPOREAL TUBING. THE PUMP NEEDED SERVICING.
THE PATIENT HAD SEVERE HYPOTENSION AND LOW CARDIAC OUTPUT AND REQUIRED RE-EXPLORATION AT THE PATIENT'S BEDSIDE. THE PATIENT'S CHEST WAS CLOSED ON 10/8/96 AND THE SECOND IAB WAS ALSO REMOVED ON 10/8/96. THE PATIENT'S PRESENT STATUS IS CRITICAL. EVENT COMPLICATIONS: PATIENT'S BLOOD PRESSURE DROPPED - REPORTED 10/4/96, 10/18/96. PATIENT'S CURRENT STATUS: CRITICAL - RPT'D 10/18/96.
THE SWITCH EMITTED SMOKE. CO'S INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROXIMATELY 1967 TO JUNE 21, 1990, COMPANY USED A SWITCH MANUFACTURED BY A REPUTABLE FIRM. THE SWITCH WAS A MOMENTARY TYPE SWITCH WITH A SPRING LOADED LEVER WHICH REQUIRED BEING HELD IN THE "ON" POSITION TO MAKE CONTACT. SOMETIMES A USER WOULD NOT FULLY ENGAGE THE LEVER, ALLOWING THE CONTACTS TO REMAIN SLIGHTLY OPEN WHICH COULD INDUCE ARCING. WHEN CONSISTENTLY HELD IN THIS WAY, CARBON BUILDING FROM THE ARCING COULD REACH OPPOSITE POLES CAUSING THE SWITCH TO EMIT A SMALL AMOUNT OF SMOKE. CO'S FIRST SOLUTION WAS TO CHANGE THE CONTACT MATERIAL AND THE BODY OF THE SWITCH. THIS REDUCED THE ARCING OF THE CONTACTS AND THE CARBON TRACKING OF THE SWITCH BODY. ALTHOUGH THE SITUATION WAS IMPROVED, THE OCCASIONAL RELEASE OF A PUFF OF SMOKE WAS POSSIBLE. ON JUNE 21, 1990 THE CO BEGAN USING A SNAP ACTION SWITCH WHICH DOES NOT ALLOW THE CONTACTS TO BE HELD IN A SLIGHTLY OPEN POSITION. THIS EVENT IS NOT REPORTABLE UNDER 21CFR803 BECAUSE SIMILAR EVENTS WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO BE COMPLIANT WITH REGULATORY LETTER 90-DT-12. REMEDIAL ACTION HAS BEEN ACCOMPLISHED.
IT WAS REPORTED THAT DURING A POST STENT DILATATION PROCEDURE, THE BALLOON RUPTURED. AS THE BALLOON CATHETER WAS REMOVED, IT BECAME CAUGHT ON THE GUIDE WIRE AND THE WIRE FRACTURED. ALL PIECES OF THE GUIDWIRE WERE REMOVED. PT STATUS IS LISTED AS "OK".
RETURNED PRODUCT ANALYSIS WAS PERFORMED ON THE BALLOON CATHETER WHICH WAS RETURNED WITH A GUIDE WIRE LOADED THROUGH THE EXCHANGE PORT. THE BALLOON MATERIAL WAS TORN CIRCUMFERENTIALLY. THE GUIDE WIRE HAD BEEN FRACTURED. FURTHER EXAM FOUND THAT A KINK OR BALLOON DAMAGE COULD NOT BE DETERMINED. SAME CASE AS MFR REPORT # 2155152-1996-00003. PIR # 24370.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED ~23MM, ~40MM, ~54MM, ~64MM, AND ~77MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES ~10MM AND HAS MIGRATED DOWN LEAD BODY ~190MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED ADD UP TO ~87MM.
DEVICE WAS IMPLANTED ON 3/24/87. THE LEFT CYLINDER WAS REMOVED, DATE NOT INDICATED. ON 6/12/96 THE RIGHT CYLINDER WAS REMOVED FROM THE PT BECAUSE IT WAS LOOSE AND FLOPPY. AN ENTIRE MALLEABLE DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO.
DURING THE PROCEDURE, THE COIL OF THIS DEVICE SEPARATED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
ON 4/23/91, DEVICE WAS IMPLANTED. ON 4/5/96, THE CYLINDERS AND PUMP WERE REVISED. ON 5/29/96, THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO INFECTION. ADD'L LOT/SER# BQ323 009.
THE IAB WAS INSERTED INTO THE PT ON 9/30/96. ON 10/2/96 AFTER IABP FOR ABOUT TWO DAYS, BLOOD WAS NOTED IN THE TUBING. AS A RESULT OF THE EVENT, THE PT WENT TO THE O.R. FOR A THROMBECTOMY.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSP.
THE LEFT CYLINDER WAS REMOVED FROM THE PT BECAUSE IT EXTRUDED FROM LEFT CORPUS CAVERNOSUM, DATE NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
THE BALLOON AND CUFF WERE REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
A 22G CATHETER INSERTED EASILY WITH GOOD BLOOD RETURN AND STYLET REMOVED. WHEN ATTEMPTING TO ADVANCE CATHETER, IT BOWED UP ABOVE THE SKIN BECOMING CONTAMINATED, AND BENT RENDERING IT UNSERVICABLE SO THE CATHETER WAS REMOVED AND ANOTHER INSERTED.
DURING A DIAGNOSTIC PROCEDURE, THE SHAFT OF THIS DEVICE RUPTURED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED OFR CO'S ANALYSIS.
DEVICE HISTORY RECOVERY REVIEW PERFORMED.
DEVICE WAS REMOVED FROM THE PT, DUE TO PUMP INFECTION, AND REPLACED. ADD LOT/SER #: BY569 007.
RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION--FLUID LOSS AND MALFUNCTION. ADD'L LOT/SER# 1678P 018.
PT HAD A PORT IMPLANTED IN 2/96. PORT NOT FUNCTIONING AND PT BROUGHT INTO HOSP FOR EXPLANT. PREOPERATIVE X-RAY SHOWED THAT PORT CATHETER HAD BROKEN INTO 2 PIECES. THE PORT WAS REMOVED AND A SECTION OF CATHETER WAS LEFT IN THE PT. THE SURGEON FEELS THE SECTION LEFT IS IMBEDDED AND THERE SHOULD NOT BE AN ADVERSE REACTION.
IMPLANTED IN 5/96. REVISION SURGERY OCCURRED ON 9/27/96, DUE TO FRACTURE OF CABLE.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSON AS TO THE CAUSE OF THE EVENT. A FAX WAS SENT TO THE USER FACILITY ON 10/10/96. CO DID NOT RECEIVE A MEDWATCH REPORT FORM FROM THE USER FACILITY.
IT WAS REPORTED THAT DURING A POST STENT DILATATION PROCEDURE, THE BALLOON RUPTURED. AS THE BALLOON CATHETER WAS REMOVED, IT BECAME CAUGHT ON THE GUIDE WIRE AND THE WIRE FRACTURED. ALL PIECES OF THE WIRE WERE REMOVED. PT STATUS IS LISTED AS "OK".
RETURNED PRODUCT ANALYSIS WAS PERFORMED ON THE GUIDE WIRE WHICH WAS RETURNED LOADED ON THE BALLOON CATHETER. THE WIRE HAD BEEN FRACTURED. FURTHER EXAM FOUND THAT A KINK OCCURRED IN THE WIRE AT THE FRACTURE SITE. THE BALLOON MATERIAL REVEALED A CIRCUMFERENTIAL TEAR. THE CAUSE OF THE WIRE KINK OR BALLOON DAMAGE COULD NOT BE DETERMINED. PIR # 24371.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS RIGHT CYLINDER.
DURING A PTCA PROCEDURE THE BALLOON OF THIS DEVICE FAILED TO INFLATE. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
DEVICE WAS REMOVED FROM THE PT DUE TO A BUCKLING OF CYLINDERS. ANOTHER DEVICE WAS IMPLANTED.
3/28/95 PT CAME TO EMERGENCY DEPT WITH C/O RESPIRATORY PROBLEMS. CHEST X-RAY REVEALED 9.0 CM CATHETER RT MID-LUNG. WEEK OF 4/10/95 RPTR WAS INFORMED THAT THE PT WAS TO HAVE CATHETER REMOVED AT ANOTHER FACILITY. PORT IMPLANTED 5/18/95 FOR MEDICATION ADMINISTRATION FOR LYMES DISEASE. PORT EXPLANTED 3/11/94.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT DUE TO FLUID LOSS LEFT INPUT TUBE. FAILED IPP POST AUTO ACCIDENT. AN ENTIRE IPP DEVICE WAS IMPLANTED.
DURING PREP THE SHAFT OF THIS DEVICE RUPTURED SPRAYING THE DR WITH CONTRAST. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR ANALYSIS.
THE BALLOON AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO URETHRAL ATROPHY.
IT WAS REPORTED THAT DURING A POST STENT DILATATION PROCEDURE, THE BALLOON RUPTURED AND A DISSECTION OCCURRED. THE DISSEACTION WAS REPAIRED WITH AN ADD'L STENT. PT STATUS IS LISTED AS "OK".
RETURNED PRODUCT ANALYSIS REVEALED A TEAR IN THE BALLOON MATERIAL. THE CAUSE OF THE BALLOON DAMAGE COULD NOT BE DETERMINED.
THE DEVICE WAS REMOVED FROM THE PT REPLACED DUE TO FLUID LOSS WHERE TUBE COMES INTO CYLINDERS.
PORT IMPLANTED FOR CHEMOTHERAPY ON 8/19/94. PT SCHEDULED FOR EXPLANT 9/18/96. PRE OPERATIVE X-RAY REVEALED A PORTION OF THE PORT CATHETER LOCATED WITH TIP PROJECTED OVER RT VENTRICLE AND LEFT MAIN PULMONARY ARTERY. 9/18/96 PORT AND ATTACHED PORTION OF CATHETER EXPLANTED. BROKEN OFF SECTION REMAINS IN PT WITH NO APPARENT ADVERSE EFFECT TO DATE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO AN INFECTION, WHICH INVOLVED THE PT PENILE PROSTHESIS.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. ONE OF THE TUBES FROM THE PUMP WAS AVULSED ADJACENT TO THE PUMP.
IT WAS REPORTED THAT DURING A POST STENT DILATAION PROCEDURE, THE BALLOON RUPTURED AND A DISSECTION OCCURRED. THE DISSECTION WAS RAPIRED WITH LOW PRESSURE INFLATIONS DISTAL TO THE STENT. PT STATUS IS LISTED AS "OK".
RETURNED PRODUCT ANALYSIS REVEALED A SMALL HOLE IN THE BALLOON MATERIAL. THE CAUSE OF THE BALLOON DAMAGE COULD NOT BE DETERMINED.
HOOK TIP HAND CONTROLLED COAGULATOR MALFUNCTIONED DURING USE.  THE "CUT" STAYED ON EVEN WHEN THE BUTTON WAS NOT BEING DEPRESSED. A FLAME WAS SEEN AT THE TIP.
A COMPLETE EVALUATION HAS BEEN DONE ON THE RETURNED HOOK TIP HAND CONTROLLED COAGULATOR. UPON DISASSEMBLY AND INSPECTION OF THIS ITEM, A SMALL AMOUNT OF CORROSION WAS DISCOVERED ON THE CUT BUTTON CONTACT SURFACE AREA.  THE CO. BELIEVES THAT THE CORROSION AND MALFUNCTION EXPERIENCED WAS CAUSED BY A CONDUCTIVE MATERIAL ENTERING INTO THE CONTACT SURFACE AREA. THE SOLUTION MAY HAVE ENTERED THE SWITCH PEN IN A NUMBER OF WAYS, BUT THE CO IS EVALUATING ADDITIONAL PREVENTATIVE MEASURES THAT CAN BE TAKEN. THE FREQUENCY AND/OR OCCURRENCE OF THIS EVENT IS NOT GREATER THAN NORMAL.
ON 5/3/94 AN AUS DEVICE WAS IMPLANTED. ON 6/20/96 A TANDEM CUFF WAS ADDED. ON 9/24/96 THE ENTIRE DEVICE, INCLUDING THE TANDEM CUFF, WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. ADD'L LOT SER NO: CB049 007.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO INFECTION RIGHT CYLINDER ANEURYSM AT TIME OF ORIGINAL IMPLANT.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDERS PERFORMED WITHIN SPECIFICATIONS. TUBING HAD OR DAMAGE.
DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS AND ANEURYSM OF RIGHT CYLINDER, AND REPLACED. UNABLE TO OBTAIN ADD'L INFO.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A BULGE LEAK.
IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE BALLOON WAS INFLATED AND THE PHYSICIAN WAS UNABLE TO SEE THE BALLOON. NEGATIVE PRESSURE WAS APPLIED AND A DISSECTION OCCURRED. THE DISSECTION WAS REPAIRED WITH A STENT. PT STATUS IS LISTED AS "OK".
RETURNED PRODUCT ANALYSIS REVEALED THE CATHETER PERFORMED ACCORDING TO SPECIFICATIONS. NO LEAKS WERE NOTED AND MARKER BANDS WERE IN THE CORRECT POSITION. NO MATERIAL OR MFG DEFICIENCIES WERE NOTED.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO PT DISSATISFACTION.
THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION -AND EROSION THROUGH THE END OF THE PENIS. ADD'L LOT SER NO: 1099P 008.
DEVICE WAS REMOVED FROM THE PT, BECAUSE IT WOULD NOT INFLATE WHEN PUMPED, AND REPLACED. ADD'L LOT/SER# X3954 025.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE.
THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO FAILURE.
FACILITY EXPERIENCED A PROBLEM WITH THE INFANT VENTILATOR. VENTILATOR RATE 52, BASE FLOW 15, INSPIRATORY FLOW 19, INSPIRATORY TIME 0.72 SECONDS. THE SETTING APPEARED AUTOMATICALLY ON THE VENTILATOR AND COULD NOT BE RE-ADJUSTED TO LOWER LEVELS. THE VENTILATOR ALARMED PROLONGED INSPIRATORY TIME. THE EVENT WAS REPEATABLE BY THE DEALER, THE PT'S CONDITION DETERIORATED CONSIDERABLY DURING THIS TIME AND WAS DISCONNECTED FROM THIS SUSPECTED FAULTY VENITLATOR AND CONNECTED TO THE DIFFERENT VENTILATOR AFTER WHICH THE PT'S CONDITION IMPROVED.
THE UNIT WAS RETURNED TO ENGINEERING, THEN RE-TESTED BY ENGINEERING UNDER HIGH TEMPERATURES IN THE RELLABILITY LAB. THE UNIT WAS FOUND TO FAIL AFTER APPROX 2 HOURS OF HIGH-TEMPERATURE TESTING. INVESTIGATION OF THE POWER SUPPLY PCB SHOWED THAT THERE WAS A BREAK IN THE SLEEVED JUMPER WIRE WHICH CONNECTS THE POWER SUPPLY'S OUTPUT TRANSISTOR TO PIN 9 OF THE CONNECTOR, DISCONNECTING THE SUPPLY. UNDER NORMAL AMBLENT TEMPERATURES, THE TWO ENDS OF THE WIRE WOULD MAKE CONTACT, BUT IN RESPONSE TO PROLONGED HIGH TEMPERATURES, THE TWO ENDS OF THE WIRE WOULD SEPARATE ENOUGH TO BREAK THE CONNECTION. SINCE THE BREAK WAS UNDERNEATH THE SLEEVE IT COULD NOT INITIALLY BE SEEN. THIS CONDITION IS NOW BELIEVED TO HAVE MIMICKED A BAD COMPONENT AT (U19) ON THE CONTROL PCB.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION DID NOT LIKE OPERATION OF THE DEVICE.
DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS-CYLINDER INPUT TUBE, AND REPLACED. ADD'L LOT/SER# 0214M 006.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A FATIGUE LEAK. TUBING HAD OR DAMAGE.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS RIGHT MID CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A FATIGUE LEAK.
ON 9/14/89 DEVICE WAS IMPLANTED. ON 1/29/90 THE CYLINDERS WERE REVISED. ON 9/23/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. ADD'L LOT/SER NO: 1203J 020.
SURGEON WAS ATTEMPTING TO TORQUE DOWN A SCREW DURING AN ORIF OF PT'S LEFT HIP WHEN THE HEAD OF THE 36 MM SCREW BROKE OFF. DURING THE SAME PROCEDURE, A PORTION OF THE THREADS OF A 38 MM SCREW CAME OFF IN THE WOUND. THE SHAFT OF THE 36 MM SCREW WAS LEFT IN THE LEFT HIP OF THE PT, BUT THE THREADS OFF THE 38 MM SCREW WERE RECOVERED.
THE PUMP WAS REMOVED FROM THE PT, DUE TO INFECTION AND A "DEFECTIVE PUMP," AND REPLACED.
STAINLESS STEEL DRILL USED IN TOTAL HIP REPLACEMENT BROKE. 1 CM FRAGMENT ASSUMED IMBEDDED IN INTERTROCANTERIC REGION. X-RAYS TAKEN AND UNABLE TO LOCATE. NO ADVERSE OUTCOME TO PT.
ADDITIONAL RECEIVED ON 1/20/97 INDICATES THE DEVICE WAS REMOVED FROM THE PATIENT ON 1/16/97 DUE TO PATIENT DISSATISFACTION--DEVICE NON-FUNCTIONING/PEYRONIES DISEASE AT SITE OF INFLATION. ANOTHER DEVICE WAS IMPLANTED.
DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS-SPLIT RESERVOIR, AND REPLACED.
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT AND REPLACED. REAR TIP EXTENDERS WERE ADDED TO THE DEVICE. REASON FOR THE REVISION HAS NOT BEEN PROVIDED.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-CYLINDER.
CYLINDER HAD A WEAR LEAK. CYLINDER PERFORMED WITHIN SPECIFICATIONS. PUMP CYCLES TO INFLATE NOT WITHIN SPECS.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS CYLINDER.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO ANEURYSM -LEFT CYLINDER. OUTER SILICONE LAYER SPLIT-FABRIC LAYER SPLIT-TISSUE INGROWTH. INNER CYLINDER INTACT-HOWEVER INNER CYLINDER HAD ANEURYSM.
THE CYLINDERS AND PUMP WERE REMOVED FROM THIS PT AND REPLACED DUE TO PAIN ON RIGHT SIDE OF PENIS AND ANEURYSM OF RIGHT CYLINDER (COULD NOT BE EMPTIED OF FLUID).
DEVICE WAS REMOVED FROM PT DUE TO INADEQUATE GIRTH AND RIGIDITY. ANOTHER DEVICE WAS IMPLANTED.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT, DUE TO INADEQUATE RIGIDITY AND FLUID LOSS-RIGHT CYLINDER, AND REPLACED.
PUMP PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A FATIGUE LEAK.
VACUUM TUBE ASSEMBLY IS VERY EASILY PULLED OUT OF ITS CONNECTION.
ON 6/5/86 DEVICE WAS IMPLANTED. ON 8/4/92 THE CYLINDERS AND PUMP WERE REVISED. ON 9/26/96 THE CYLINDERS AND RESERVOIR WERE REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACTION -NOT ENOUGH FLUID IN 65ML RESERVOIR.
RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER WAS FUNCTIONAL.
IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE BALLOON CATHETER WAS PLACED THROUGH THE SIDE OF A PREVIOUSLY IMPALNTED STENT TO REACH THE OSTIUM OF A SIDE BRANCH BLOCKED BY THE STENT. UPON REMOVAL THE CATHETER SHAFT FRACTURED. THE DISTAL TIP OF THE SHAFT AND A PORTION OF THE BALLOON MATERIAL REMAINED IN THE ARTERY. THE PT WAS TRANSFERRED TO ANOTHER HOSP FOR RETRIEVAL OF THE CATHETER TIP. RETRIEVAL ATTEMPTS WERE UNSUCCESSFUL AND THE PT SUBSEQUENTLY WENT TO SURGERY ON 10/8/96 WHERE THE CATHETER TIP AND BALLOON PORTION WERE REMOVED. PT STATUS IS LISTED AS "DOING WELL".
INITIALLY, CORONARY STENT INSERTED INTO PROXIMAL AND MID-CIRCUMFLEX ARTERIES IN 8/96. ON 10/7/96, ANGIOPLASTY OF OBTWUSE MARGINAL ARTERY PERFORMED, PTCA BALLOON RUPTURED INTO TWO PIECES WITH PROXIMAL PORTION REMAINING IN THE VESSEL. PHYSICIAN PASSED PTCA BALLOON THROUGH THE STENT TO DILATE STENOSIS. PT EVENTUALLY UNDERWENT OPEN CHEST PROCEDURE TO RETRIEVE BALLOON FRAGMENT.
RETURNED PRODUCT ANALYSIS A CIRCUMFERENTIAL AND A LONGITUDINAL TEAR IN THE BALLOON MATERIAL. ANALYSIS ALSO REVEALED THE INNER LUMEN WAS STRETCHED AND SEPARATED FROM THE REMAINDER OF THE SHAFT BEYOND THE MARKER BAND. THE CAUSE OF THE BALLOON BURST COULD NOT BE DETERMINED. THE DAMAGED BALLOON MAY HAVE BECOME CAUGHT IN THE STENT. THE SHAFT APPEARS TO BE STRETCHED AND SEPARATED DUE TO TENSILE FORCES THAT WERE APPLIED.
ON 4/15/94 DEVICE WAS IMPLANTED. ON 12/13/95 THE RESERVOIR WAS RELOCATED. ON 10/02/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION INTO THE URETHRA.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDERS HAD OR DAMAGE.
ON 6/6/95 AN AUS DEVICE WAS IMPLANTED. ON 9/25/96 THE CUFF AND BALLOON WERE REVISED. ON 9/27/96 THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-BOTH CYLINDERS RUPTURED, OUTER SILICONE LAYER FRAGMENTED.
TUBING WAS FUNCTIONAL. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD A WEAR LEAK.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE FLUID LOSS.
THE BALLOON AND PUMP WERE REMOVED FROM THE PT DUE TO FLUID LOSS-PUMP.
PUMP/TUBING JUNCTION HAD A FATIGUE LEAK. BALLOON PERFORMED WITHIN SPECIFICATIONS.
THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER# 0943T 003.
USER REPORTS SUTURE BREAKAGE OCCURRING TWICE FOLLOWING EPIGASTRIC HERNIA REPAIR ON OBESE PT WITH CHRONIC COUGH.
TWELVE SAMPLES (TEN OF BATCH JJE286 AND ONE EACH OF BATCHES JHE622 AND JDE375) OF THE RETURNED PRODUCT WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND THE RESULTS OBTAINED WERE ABOVE THE ETHICONE REQUIREMENTS, WHICH ALWAYS EQUAL OR EXCEED THE MINIMUM USP REQUIREMENTS. A PRODUCT INQUIRY RECORDS REVIEW WAS ALSO CONDUCTED AND THERE HAVE BEEN NO OTHER INQUIRIES OF ANY TYPE RECEIVED INVOLVING ANY OF THESE BATCH NUMBERS.
ON 1/30/95 AN AUS DEVICE WAS IMPLANTED. ON 3/1/95 THE PUMP WAS REVISED. ON 10/1/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO CRYO-THERAPY RESULTING IN CUFF EROSION OF THE URETHRA.
PRINTER PRINTS WITH MISSING CHARACTERS AND SOMETIMES WILL NOT PRINT AT ALL. PRINTER WILL PASS SELF TEST, PRINT DIAGNOSTIC, MISLEADING OPERATOR TO BELIEVE THERE IS NO PROBLEM WITH THE EQUIPMENT. THIS PROBLEM IS CAUSED DUE TO THE PRINTED CIRCUIT CPU BOARD BEING LOCATED IN CLOSE PROXIMITY TO THE STERILE WATER FILTER HOUSING. THE CPU BOARD CONTROLS ALL THE FUNCTIONS OF THIS STERILIZER. THE POTENTIAL EXISTS THAT OTHER MALFUNCTIONS MAY ARISE IF THE CPU BOARD IS COMPROMISED. IT IS POSSIBLE THAT THE UNIT MAY APPEAR TO FUNCTION NORMALLY, HOWEVER THE STERILIZATION PROCESS MAY BE COMPROMISED. WHEN THE USER CHANGES THE STERILE WATER FILTER, THE POTENTIAL TO LEAK WATER INTO THE CPU SECTION IS GREAT. RPTR BELIEVES THIS TO BE THE CAUSE OF THEIR PROBLEMS. RPTR HAS HAD TO REPLACE TWO CPU CONTROLLER BOARDS THUS FAR. RPTR HAS MADE THEIR USERS AWARE TO THE CAUSE OF THESE PROBLEMS. THE MFR DOES NOT BELIEVE THE PROBLEM IS WITH THE CONTROLLER BOARD AS COMPLAINANT BELIEVES. THEY RECOMMEND FOLLOWING OPERATOR MANUAL PAGE 7-7 CONCERNING FILTER REPLACEMENT AND SVC MANUAL PAGE 5.43 CONCERNING TRACING PROBLEM BY ATTACHING COMPONENTS SEPARATELY AND TRYING PRINTER, AND THIRD SUGGESTION IS TO CALL FOR SVC. PLEASE NOTE THE PRINTER BOARD AND CONTROLLER BOARD ARE LOCATED SEPARATELY. THE PRINTER BOARD IS SIMPLY COVERED WITH A PLASTIC LID AND IS DESIGNED SO THAT THE SLIGHTEST INTERFERENCE (WATER)  WILL RENDER IT UNUSABLE. THE PRINTER BOARD IS MERELY AN INFO EXCHANGE LOCATION BETWEEN THE CONTROLLER BOARD AND THE PRINTER MECHANISM. THIS BOARD IN NO WAY MONITORS OR AFFECTS ANY STERILIZATION PARAMETERS OR FUNCTIONS. THE SELF TEST RUN ON THE PRINTER MERELY ENSURES THAT THE PRINTER IS ABLE TO PRINT. DURING THIS TEST, THE SYSTEM IS NOT MONITORED FOR PERFORMANCE. THUS, IF THE PRINTER IS FUNCTIONING PROPERLY, IT WILL PASS THE SELF PRINT DIAGNOSTIC. THE CONTROLLER BOARDS CONTROLLING ALL MONITORING FUNCTIONS FOR THE SYSTEM ARE LOCATED IN AN ELECTRONICS ENCLOSURE. THE LID TO THIS ENCLOSURE IS LIPPED AND CONTAINS A GASKET SEAL TO PREVENT MOISTURE FROM ENTERING THE ENCLOSURE. ADDITIONALLY, THE PROCESSOR CONSTANTLY MONITORS SEVERAL KEY FACTORS DURING THE STERILIZATION PROCESS: EXPOSURE TIME, CONCENTRATION LEVEL, FLUID LEVEL, AND TEMP. ALL MECHANICAL, ELECTRICAL AND ELECTRONIC FUNCTIONS ARE TESTED DURING THE SELF DIAGNOSTIC TEST THAT IS COMPLETED DAILY. IF, PER CHANCE, THE CONTROLLER BOARDS WERE DAMAGED (BY WATER OR OTHER), THE SYSTEM WOULD IMMEDIATELY CEASE TO FUNCTION, OR IF THE BOARDS WERE DAMAGED MID-CYCLE, THE SYSTEM WOULD DETECT A FAULT AND CANCEL THE CYCLE. THE SYSTEM IS APPROVED BY THE UNDERWRITER'S LAB IN ITS CURRENT DESIGN. UL EVALUATED THE SAFETY HAZARDS ASSOCIATED WITH USE OF THE SYSTEM SPECIFICALLY, THE PROCEDURE FOR REPLACING THE STERILE WATER FILTER. UPON CONCLUSION OF THE ASSESSMENT, UL MADE THE FOLLOWING COMMENT: "NO PARTS WHICH CONSTITUTE A SHOCK HAZARD ARE RENDERED ACCESSIBLE" DURING THIS PROCEDURE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO A HEMATOMA, SCAR TISSUE, AND INFECTION. A MALLEABLE DEVICE WAS IMPLANTED ON LEFT SIDE ONLY.
IT WAS REPORTED THAT DURING A POST STENT DILATATION PROCEDURE, THE BALLOON RUPTURED. IT WAS ALSO REPORTED THAT THE PT WENT TO BY PASS SURGERY BUT NOT AS RESULT OF THIS INCIDENT. IT WAS SUBSEQUENTLY REPORTED ON 10/28/96 THAT THE PT WENT TO BY PASS SURGERY ON 10/11/96 BECAUSE THE STENT MOVED INTO THE MIDDLE OF THE ARTERY AND THEY WERE UNABLE TO PROPERLY DEPLOY IT OR PASS ANYTHING THROUGH IT. THE PT EXPIRED ON 10/13/96. THE CAUSE OF DEATH WAS NOT AVAILABLE.
USER FACILITY REPORTED NEEDLE PULLED OFF THE SUTURE, REQUIRING A SECOND INCISION, WHICH EXTENDED DENTAL SURGERY BY 30 MINS.
H6- TWO SAMPLES FROM UNOPENED PACKETS RETURNED WERE TESTED FOR NEEDLE PULL OFF AND THE RESULTS WERE ABOVE THE USP AND CO REQUIREMENTS.
INFO RECEIVED ON 8/21/96 INDICATES THAT ONE OF THE DR'S PTS HAS A BROKEN STIFFENER ROD. PT, DR, AND SURGERY INFO HAS NOT BEEN PROVIDED AT THIS TIME.
INFORMATION RECEIVED ON 12/2/96 INDICATES REASON AS ATROPHY AT CUFF.
IT WAS REPORTED THAT DURING A POST STENT DILATATION PROCEDURE, THE BALLOON ACTED COMPLIANT (GREW AND BULGED) AND A DISSECTION OCCURRED. THE DISSECTION WAS REPAIRED WITH ANOTHER BALLOON. THE PT SUBSEQUENTLY EXPIRED ON 10/9/96. CAUSE OF DEATH WAS NOT AVAILABLE. THE PT WAS A DIABETIC WHO WAS IN RENAL FAILURE.
RETURNED PRODUCT ANALYSIS REVEALED THE BALLOON CATHETER PERFORMED PER PRODUCT SPECIFICATIONS. BALLOON DIAMTERES WERE MEASURED AT MULTIPLE ATM'S AND MET SPECIFICATIONS. NO DAMAGE TO THE BALLOON WAS OBSERVED. THE CAUSE OF THE REPORTED BALLOON COMPLIANCE DIFFICULTY COULD NOT BE DETERMINED. NO MATERIAL OF MFG DEFICIENCIES WERE NOTED.
INFO RECEIVED INDICATES PT HAD BROKEN STIFFENER. NO FURTHER INFO HAS BEEN PROVIDED AT THIS TIME.
SENSITIZATION AND ALLERGIC REACTION TO LATEX GLOVES.
AN EVALUATION WAS NOT PERFORMED SINCE NO SAMPLE, LOT NUMBER, OR PRODUCT NUMBER WAS RETURNED OR IDENTIFIED. IT IS NOT KNOWN NOR CAN IT BE DETERMINED IF CO WAS RESPONSIBLE FOR THE EVENT. THE LAW SUIT NAMES TWELVE (12) DIFFERENT GLOVE MFRS.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-RESERVOIR.
CO RECEIVED INFO ON A DEATH CERTIFICATE THAT THE PT HAD EXPIRED DUE TO AN ACUTE CARDIAC ARREST AS A CONSEQUENCE OF A CORONARY ARTERY DISEASE.
THIS REPORT IS ITS ENTIRETY WAS COMPLETED SOLELY BY CO. EXPLANT TO DATE CO HAS NEITHER RECEIVED THE ICD NOR BEEN INFORMED THAT THE DEVICE HAS BEEN EXPLANTED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED, DATE NOT INDICATED DUE TO CAVERNOUS CORPUS EROSION.
COMPLAINANT STATES THAT THE PT'S LEFT HIP PROSTHESIS FAILED PREMATURELY. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT  CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR  CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF LEAVING CO OR ITS AFFILIATES. D.6.-THE EXACT SIZE OF THE IMPLANT IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO. H.4-THE DEVICE MFG DATE IS UNKNOWN BECAUSE THE MFG LOT NUMBER WAS NOT PROVIDED TO CO.
ON 8/31/92 AN AUS DEVICE WAS IMPLANTED. ON 6/28/96 A TANDEM CUFF WAS IMPLANTED DUE TO RECURRING INCONTINENCE. NO COMPONENTS REMOVED OR REPLACED.
THE EZ35B WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE SURGEON FIRED THE DEVICE AND IT DID NOT CUT. A SURGEON MADE A SMALL OPEN INCISION TO COMPLETE PROCEDURE. DEVICE SERIAL # 0204.
10/4/96 1405 MESSAGE AND 800# LEFT ON RISK MGR'S ANSWERING MACHINE. DAMAGED FIRING MECHANISM A1,2,3,4; B3,6,7, D5,6,10; H4; INFO UNAVAILABLE. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. THE RETURNED CARTRIDGE HAD TWO MALFORMED STAPLES IN THE DISTAL POCKETS. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED DURING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
ALLERGIC REACTION-RN PUT ON GLOVES AND WITHIN MINS BEGIN TO BREAK OUT OF THE HANDS IN HIVES-SEVERE REACTION.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
DIST REPORTED, CUSTOMER WAS SETTING UP PRODUCT FOR USE AND OBSERVED FLEX TUBE AND MOUTHPIECE IMPROPERLY ASSEMBLED TO VALVE HOUSING. NO PT INVOLVEMENT.
ALTHOUGH CO CONFIRMED THE PRODUCT WAS INCORRECTLY ASSEMBLED, THE FAILURE INVESTIGATION IS UNDERWAY. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF FAILURE INVESTIGATION.
THE USER COULD NOT ADVANCE THE WIRE OR LOOSEN THE ADAPTER. WHEN THE INCIDENT OCCURRED, NO ADD'L FILTERS WERE AVAILABLE IN INVENTORY. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH ANOTHER SYSTEM.
FULL EVALUATION WAS NOT POSSIBLE SINCE DELIVERY SYSTEM WAS RETURNED WITHOUT FILTER.
COMPLAINANT STATES THAT THE PT'S RIGHT HIP PROSTHESIS FAILED PREMATURELY. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITWUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF LEAVING OR ITS AFFILIATES. D.6-THE EXACT SIZE OF THEIMPLANTS IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO. H.4-THE DEVICE MFG DATE IS UNKNOWN BECAUSE THE MFG LOT NUMBER WAS NOT PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS A ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF LEAVING OOR ITS AFFILIATES. D.6- THE EXACT SIZE OF THE IMPLANT IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED TO CO. H-4. THE DEVICE MFG DATE IS UNKNOWN BECAUSE THE MFG LOT NUMBER WAS NOT PROVIDED TO CO.
THE CUFF WAS REMOVED FROM THE PT, DUE TO EROSION, AND REPLACED.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. ADD'L LOT/SER NO: 6387M 001.
TUBING WAS FUNCTIONAL. PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD OR DAMAGE. RESERVOIR HAD A FATIGUE LEAK.
THIS EVENT WAS REPORTED AS SHORTNESS OF BREATH AND SEVERE MITRAL REGURGITAION. NO FURTHER INFO PROVIDED.
UROLOGIST REPORTS: "INITIALLY THE OPERATION WAS GOOD REGARDING THE SIZE AND THE LENGTH. NOW THE SIZE AND LENGTH IS LESS".
THE DEVICE WAS REMOVED FORM THE PT AND REPLACED DUE TO FLUID LOSS-ANEURYSMAL DILATATION OF CYLINDERS.
WHILE THE PHYSICIAN WAS PLACING THE GUIDING CATHETER, IN THE PT, THE GUIDING CATHETER BECAME KINKED. THE PT WAS TAKEN TO SURGERY FOR REMOVAL OF THE GUIDING CATHETER. PT IS REPORTEDLY DOING WELL POST OPERATIVELY. THIS WAS THE PHYSICIAN'S FIRST ENCOUNTER WITH THIS GUIDING CATHETER.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. TYPE OF EVENT ADDRESSED IN LABELING (SECTION F10) 1701 FOR CODE 2365 & 1528. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSP OR DISTRIBUTOR.
THIS EVENT WAS REPORTED AS MITRAL REGURGITATION FROM A "DYSFUNCTIONING" PIG VALVE. NO FURTHER INFO PROVIDED.
ON 8/31/81 DEVICE WAS IMPLANTED. ON 9/5/91 THE RESERVOIR WAS REVISED. ON 2/6/92 THE CYLINDERS AND PUMP WERE REVISED. ON 12/13/94 A REVISION SURGERY OCCURRED DUE TO EROSION. ON 5/28/96 THE LEFT CYLINDER WAS REMOVED FROM THE PT. ON 9/24/96 THE RIGHT CYLINDER WAS REMOVED FROM THE PT DUE TO PAIN-RIGHT SIDE OF PENIS.
THE DEVICE WAS REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE ATROPHY.
PUMP PERFORMED WITHIN SPECS. CUFF PERFORMED WITHIN SPECS. BALLOON PERFORMED WITHIN SPECS. CUFF HAD OR DAMAGE.
THE DEVICE WAS USED DURING A WHIPPLE PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT OPEN. THE SURGEON RESECTED THE TISSUE TO REMOVE THE DEVICE. THE HOSP HAS NOT PROVIDED ANY FURTHER INFO.
11/1/96 -MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 11/3/88. PT ALSO ALLEGES HAVING LEAKAGE AND RUPTURE ON 6/5/96; THEREFORE, PT HAD REMOVAL AND REPLACEMENT OF ONE IMPLANT ON 9/17/96. CO IS UNABLE TO DETERMINE WHICH IMPLANT WAS REMOVED. PHYSICIAN'S NOTE STATES "POSSIBLE RUPTURE AND PAIN CONFIRMED ON MAMMOGRAM AND ULTRASOUND."  PT ALSO ALLEGES HAVING OTHER PROCEDURES PERFORMED ON HER BREASTS, INCLUDING DEBRIDING OF RIGHT AND LEFT BREAST WOUND, SSG (SUBCUTANEOUS SKIN GRAFT) TO DEFECT LEFT BREAST, LEFT AUGMENTATION, SCAR REVISION RIGHT AND LEFT BREAST, LEFT NIPPLE RECONSTRUCTION USING NIPPLE SHARING AND FTG (FEMORAL TISSUE GRAFT) FROM GROIN, SCAR REVISION RIGHT BREAST, EXCISION MOLE ABDOMEN, CORRECTION CONTOUR DEFORMITY LEFT BREAST, LOCALIZED LIPECTOMY RIGHT LATERAL CHEST, SCAR REVISION AND FLAT LEFT BREAST, LEFT NIPPLE RECONSTRUCTION, EXCISION BREAST LUMP RIGHT BREAST, LEFT NIPPLE RECONSTRUCTION, LEFT BREAST LUMP REMOVED.
CONCLUSION: 68A NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN.
A LETTTER WAS RECEIVED WHICH INDICATED THAT AN UNSUBSTANTIATED LEGAL PETITION ALLEGES THAT AS A RESULT OF FALLING OFF A GURNEY, PLAINTIFF SUFFERED SERIOUS INJURIES RESULTING IN A "BURST OR DISLODGED BREAST IMPLANT".
AS THE DEVICE WAS NOT RETURNED, NO PHYSICAL EVAL WAS POSSIBLE, AND NO CONCLUSION CAN BE DRAWN. AS PER CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CUI CORPORATION THAT THE REPORT OR INFORMATION THEREIN CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. REPORTS ARE BASED ON INFORMATION SUPPLIED TO CUI CORPORATION WITHOUT ITS INDEPENDENT VERIFICATION AS TO ITS ACCURACY OR COMPLETENESS. IT IS UNDERSTOOD THAT THE INFO MAY NOT REPRESENT FACT AFTER INVESTIGATION.
IT WAS REPORTED DIFFICULT DEFLATION WAS ENCOUNTERED DURING A DILATATION OF AN ARTERIOVENOUS HEMODIALYSIS FISTULA GRAFT. FULL DEFLATION WAS EVENTUALLY ACHIEVED. UPON WITHDRAWAL OF THE BALLOON CATHETER, IT WAS NOTED THE BALLOON MATERIAL HAD DETACHED FROM THE CATHETER SHAFT. RETRIEVAL OF THE BALLOON MATERIAL UTILIZING A SNARE WAS UNEVENTFUL. THE DILATATION WAS SUCCESSFUL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AT THE TIME WITHOUT PT COMPLICATIONS. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE DETACHED BALLOON MATERIAL MEASURED APPROX 5CM. BOTH BALLOON BONDS WERE PRESENT. THE SHAFT WAS FLATTENED FOR 8CM BEGINNING 12CM FROM THE DISTAL TIP. THE BALLOON MATERIAL WAS VERY WRINKLED. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. THE PT'S CONDITION AND/OR THE PROCEDURE MAY HAVE CAUSED THE CATHETER SHAFT TO FLATTEN WHICH IN TURN RESULTED IN BALLOON DEFLATION DIFFICULTIES.
THE DEVICE WAS USED DURING A HIATAL HERNIA PROCEDURE. REPORTEDLY, THE TROCAR PUNCTURED THE LOWER AORTA, THE PT LOST THREE LITERS OF BLOOD AND REQUIRED A TRANSFUSION. THE SURGEON PERFORMED A LAPAROTOMY. THE AORTA WAS REPAIRED WITH SUTURE. THE HOSP HAS REPORTED THAT THE PT'S CONDITION IS SATISFACTORY.
11/1/96 MEDWATCH REPORT NOT REC'D BY MFG.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 9/8/89. PT ALSO ALLEGES EXPERIENCING PROBLEMS, INCLUDING TENDERNESS AND A LUMP IN HER LEFT BREAST IN 7/95. PT PLANS TO HAVE REMOVAL.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE DR WAS UNABLE TO ACTIVATE THE DEVICE.
CATHETER SHEARED/PINCHED-OFF AND MIGRATED. PT HAD TO UNDER GO SURGERY TO REMOVE CATHETER FROM FEMORAL VEIN. PT IN ICU.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO MALFUNCTION.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 8/15/83. PT ALSO ALLEGES BETWEEN 1990 AND 1995 SHE HAD ANEMIA AND INJECTIONS, ALLERGIES AND HYPERSENSITIVITY TO MERCURY AND AMALGAM. IN 1/1994 SHE DEVELOPED CLINICAL DEPRESSION AND INSOMNIA. PT ALSO ALLEGES HER LEFT PROSTHESIS RUPTURED AND HER LEFT BREAST DIMINISHED IN 12/1994; THEREFORE, SHE HAD REMOVAL AND REPLACEMENT OF BOTH IMPLANTS ON 1/26/95 WITH SALINE DEVICES OF ANOTHER MFR.
CONCLUSION: 68A NO DEVICE RETURNED. NO CONLCUSION CAN BE DRAWN.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO COMPRESSION OF CUFF.
PLAINTIFF REPORTS BILATERAL IMPLANTATION 3/3/83 WITH REPLACEMENT 5/22/84. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO SCLERODERMA, RHEUMATOID ARTHRITIS, AND CHRONIC FATIGUE.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CORPORATION CEASED MFR AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF A CORPORATION IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE TROCAR WAS INSERTED INTRA-UMBILICAS WITHOUT DIFFICULTY. A LAPAROSCOPE WAS INSERTED AND BLOOD WAS OBSERVED IN THE ABDOMEN. THE SURGEON CONVERTED TO AN OPEN PROCEDURE TO REPAIR THE RIGHT ILIAC ARTERY AND VEIN. THE HOSP HAS REPORTED THAT THE PT'S CONDITION IS SATISFACTORY.
12/17/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN B7.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 10/10/84. PT ALSO ALLEGES EXPERIENCING PROBLEMS, INCLUDING PAIN AND DISCOMFORT, BEGINNING IN 2/1996. PHYSICIAN'S NOTE STATES "BILATERAL IMPLANT RUPTURE AND CAPSULE FORMATION." PT PLANS TO HAVE REMOVAL.
THE DEVICE WAS USED DURING A TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE MALFORMED STAPLE LINE AND APPLIED ANOTHER DEVICE.
11/1/96 MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
CONCLUSION STATEMENT: NO CONCLUSION CAN BE DRAWN. THE USER REFUSED TO PROVIDE SUFFICIENT INFO FOR EVAL. PRODUCT WAS MFR AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 6/8/82 WITH REPLACEMENT 3/3/83. PLAINTIFF ALLEGES VARIOUS ILNESSES INCLUDING, BUT NOT LIMITED TO, SCLERODERMA, RHEUMATOID ARTHRITIS, AND CHRONIC FATIGUE.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CORPORATION CEASED MFR AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANT IS A RESULT OF ITS ACQUISITION OF CORPORATION IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
WHEN THE PHYSICIAN INSERTED THE IAB, THE PUMP ALARMED. HE CHANGED THE INFLATION VOLUME TO 30-35CC, BUT THE BALLOON WOULD NOT INFLATE TO FULL CAPACITY. THE IAB WAS REMOVED AND REPLACED AND THERE WERE NO PT COMPLICATIONS.
SAMPLE WAS RETURNED FOR EVALUATION. THE BLADDER WAS CONFIRMED TO BE LEAKING. THE AREA THAT LEAKS DOES NOT APPEAR TO BE ABRADED, BUT APPEARS TO HAVE BEEN PUNCTURED. THE IAB MAY HAVE COME INTO CONTACT WITH A SHARP INSTRUMENT OR PLAQUE DURING INSERTION. THE PRODUCT LABELING CAUTIONS THAT "DURING AND FOLLOWING INSERTION, THE PRESENCE OF SHARP ATHEROSCLEROTIC PLAQUES MAY ABRADE AND WEAKEN THE IAB MEMBRANE, RESULTING OF POSSIBLE PUNCTURE OF THE MEMBRANE.
PT RECEIVED BREAST IMPLANTS IN 1980 OF AN UNK MFR. PT ALLEGES DISCOMFORT IN 10/1982, BLEEDING IN 8/1984 AND HARDENING IN 11/1984. PT ALSO ALLEGES HAVING ABOUT EIGHT SEPARATE OPERATIONS TO CORRECT PROBLEMS, ALL PROCEDURES INVOLVED REMOVAL AND REPLACEMENTS; HOWEVER, NO SPECIFIC DATES WERE GIVEN. REF. MW072674A, MW072674B.
CONCLUSION: 68A NO DEVICE RETURNED. NO CONCLUSION CAN BE DRAWN.
THE DEVICE WAS IMPLANTED ON 10/7/96 FOR INFUSION OF CHEMOTHERAPY FOR TREATMENT OF CANCER. ON 10/18/96, THE FACILITY'S CLINICAL COORDINATOR INFORMED THE MFR THAT ON 10/16/96 DURING A DEVICE REFILL THERE WAS NO RETURN VOLUME, THUS THE RESERVOIR VOLUME WAS BELIEVED TO BE 0 ML AND THE DEVICE WAS THOUGHT TO BE DRY DUE TO A FAST FLOW CONDITION (PREDICTED FLOW RATE -1.7 ML/DAY: CALCULATED FLOW RATE > 3.6 ML/DAY). THE DEVICE WAS REFILLED WITH 32 ML OF CHEMOTHERAPY DRUG. ON 10/18/96 THE DEVICE PORT WAS ACCESSED TO DETERMINE PATENCY DUE TO THE BELIEF ON 10/16/96 THAT THE DEVICE WAS EMPTY. THE DEVICE PORT FLUSHES EASILY AND WAS DETERMINED TO BE PATENT. DURING THIS PROCEDURE IT WAS NOTED THAT THE PT'S SKIN SURROUNDING THE DEVICE AND DEVICE SEPTUM WAS BRUISED AND DISCOLORED. ON 10/19/96 THE DEVICE WAS ACCESSED TO ASSESS THE DEVICE FLOW RATE. THE RETURN VOLUME WAS 7 ML AND THE CALCULATED FLOW RATE SINCE THE LAST REFILL ON 10/16/96 WAS 8.3 ML/DAY. THE RETURNED FLUID WAS DESCRIBED AS CLEAR. CHEMOTHERAPY WAS DISCONTINUED AND THE DEVICE WAS REFILLED WITH HEPARINIZED SALINE. IT WAS FURTHER REPORTED  THAT THE PT'S SKIN CONDITION APPEARED VERY ECCHYMOTIC WITH SOME BLISTERING OVER AND AROUND THE DEVICE.
THIS REPORT CONCERNS A DEVICE THAT IS SUBJECT OF A CLINICAL STUDY UNDER AN APPROVED INVESTIGATIONAL DEVICE EXEMPTION (IDE). THE DEVICE WAS ACCESSED ON 10/24/96 AND THE RETURN VOLUME WAS 23 ML. THE CALCULATED FLOW RATE SINCE THE LAST REFILL ON 10/19/96 WAS 1.8 ML/DAY WHICH IS WITHIN THE MFR'S SPECIFICATIONS FOR THIS DEVICE. IT IS BELIEVED THAT DURING THE INITIAL REFILL ON 10/16/96 THAT THE NURSE DID NOT HAVE THE REFILL NEEDLE SITUATED PROPERLY IN THE REFILL SEPTUM. THIS CAUSED THE NURSE TO GET NO RETURN VOLUME AND LED HER TO THE MISBELIEF THAT THE DEVICE WAS EMPTY AND FLOWING FAST. THE ATTEMPTED REFILL CAUSED THE CHEMOTHERAPY DRUG TO BE EXTRAVASATED INTO THE DEVICE POCKET. THIS BELIEF IS SUPPORTED BY THE FOLLOWING INFO. 1) ALTHOUGH A NURSE WHO HAD BEEN PREVIOUSLY IN-SERVICED ON THE REFILL PROCEDURES FOR THIS DEVICE OBSERVED THE REFILL PROCEDURE, THE ACTUAL REFILL PROCEDURE WAS PERFORMED BY A SECOND NURSE WHO WAS NOT IN-SERVICED; 2) ON 10/18/96 AND 10/19/96 DURING DEVICE ACCESS THE PT'S SKIN AROUND THE DEVICE POCKET WAS DESCRIBED AS BRUISED, DISCOLORED, ECCHYMOTIC, AND BLISTERED; 3) WHEN THE DEVICE FLOW RATE IS CALCULATED FOR THE 10/19/96 REFILL BASED ON THE BELIEF THAT THE PUMP WAS NOT REFILLED ON 10/16/96 THE CALCULATED FLOW RATE IS 1.9 ML/DAY: PREDICTED FLOW RATE -1.7 ML/DAY; 4: THE CALCULATED FLOW RATE ON 10/19/96 OF 8.3 ML/DAY IS AN INCREASE OF 488% OVER THE PREDICTED FLOW RATE FOR THE DEVICE, HOWEVER, FIVE DAYS LATER AT THE 10/24/96 REFILL THE DEVICE WAS FOUND TO BE FLOWING WITHIN THE MFR'S SPECIFICATION; AND 5) THE RETURN FLUID ON 10/19/96 WAS DESCRIBED AS CLEAR WHICH IS CONSISTENT WITH THE DEVICE CONTAINING ONLY HEPARINIZED SALINE. FURTHER, IT IS THE OPINION OF THE PRINCIPAL INVESTIGATOR THAT AN EXTRAVASATION HAD OCCURRED DUE TO THE PT'S CONDITION. THE SITUATION HAS BEEN CLASSIFIED AS RESOLVED AS OF 10/28/96. AS A CORRECTIVE ACTION, THE NURSE WHO ACCESSED THE DEVICE ON 10/16/96 HAS BEEN IN-SERVICED. FURTHER, THE NURSING STAFF HAS BEEN PROVIDED WITH ADD'L TRAINING IN THE REFILL AND PORT PROCEDURES FOR THE DEVICE. THE DEVICE REMAINS IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN; THEREFORE, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES FOR THIS DEVICE RELATED TO THIS EVENT. BASED ON THE INFO AVAILABLE. THIS EVENT APPEARS TO BE DUE TO THE NURSE THAT PERFORMED THE INITIAL REFILL ON 10/16/96, WHO DID NOT HAVE THE REFILL NEEDLE SITUATED PROPERLY IN THE DEVICE REFILL SEPTUM. THIS CAUSED THE CHEMOTHERAPY DRUG TO BE EXTRAVASATED INTO THE DEVICE POCKET WHICH LED TO THE MISBELIEF THAT THE DEVICE WAS EMPTY AND FLOWING FAST. THE SITUATION HAS BEEN CLASSIFIED AS RESOLVED. AS A CORRECTIVE ACTION, THE NURSE WHO INITIALLY ACCESSED THE DEVICE ON 10/16/96 HAS BEEN IN-SERVICED.
THE DEVICE WAS USED TO CREATE AN ANASTOMOSIS DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE STAPLE LINES WERE NOT HEMOSTATIC REQUIRING A REOPERATION TO REAPPLY ANOTHER DEVICE. THE FAILED STAPLE LINE WAS RESECTED. THE SURGEON DESCRIBED THE PT AS A "BLEEDER" AND NOTED SEVERAL "SMALL BLEEDING" AREA IN ADDITION TO THE APPLICATION SITE OF THE SUBJECT DEVICE.
THE SUBJECT DEVICE WAS DISCARDED POST-OPERATIVELY. HOWEVER, A TISSUE SPECIMEN REMOVED FROM THE PATIENT WAS EVALUATED. THE SPECIMEN WAS IN SEVERAL SMALL IRREGULARLY SHAPED PIECES WITH MULTIPLE STAPLE LINES. FUNCTIONAL CLOSURE WAS OBSERVED IN MOST STAPLES. THREE STAPLES WERE OBSERVED TO BE MALFORMED. WE COULD NOT DETERMINE IF THESE THREE STAPLES WERE MALFORMED AS A RESULT OF BEING FIRED OR AS A RESULT OF THE MANIPULATION BY THE SURGEON COULD NOT BE DETERMINED WITHOUT THE A THOROUGH EVALUATION OF THE SUBJECT DEVICE.
THIS EVENT WSA REPORTED AS INSUFFICIENCY. NO FURTHER INFO PROVIDED.
FOUR BURNS TO LEFT THIGH AREA, POOR CONTACT OF GROUNDING PAD.
THIS EVENT WAS REPORTED AS "DEGENERATION" AND INSUFFICIENCY. NO FURTHER INFO PROVIDED.
PT RECEIVED 16 CC BOLUS OF PROPOFOL DRIP ON CO PUMP WHEN STAFF SET MG/HR RATHER THAN CC/HR. REQUIRED INTERVENTION. RECOVERED TO BASELINE.
BLADE BROKE WHILE PHYSICIAN WAS INTUBATING PT. TEETH MARKS ON BLADE AND PT'S TEETH BROKE. INITIAL REPORTER STATED PHYSICIAN'S TECHNIQUE WAS QUESTIONABLE.
THE HIP IMPLANT WAS REVISED DUE TO LOOSENING OF THE BONE CEMENT.
SUMMARY OF EVALUATION: EVALUATION RESULTS SUGGEST THAT THE CAUSE OF THE COMPLAINT IS NOT PRODUCT RELATED. A REVIEW OF THE DEVICE MFG RECORDS AND RESULTS OF PRODUCT TESTING INDICATED NO EVIDENCE OF ANY ABNORMALITIES THAT WOULD RESULT IN THE CONDITION OBSERVED.
PT RECEIVED A LEFT BREAST IMPLANT ON 6/25/85 AS A REPLACEMENT FOR ONE OF AN UNK MFR. PT ALSO ALLEGES HAVING PAIN BEGINNING IN 1/1996. PHYSICIAN STATES PT HAD DISCOMFORT AND TENDERNESS. PT'S IMPLANT WAS SCHEDULED FOR REMOVAL ON 9/18/96; HOWEVER, CO IS UNCERTAIN IF REMOVAL TOOK PLACE.
THIS MDR IS BEING FILED IN ORDER TO COMPLY WITH 21 CFR PART 803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT THE DEVICE ACTUALLY MALFUNCTIONED OR CAUSED ANY INJURY.
THIS EVENT WAS REPORTED AS A PARABASILAR LEAK. NO FURTHER INFO PROVIDED. THIS DEVICE REMAINS IMPLANTED.
THE CUSTOMER SENT A MEDWATCH REPORT THAT INDICATED "THE PT WAS PUT TO SLEEP UNDER GENERAL ANESTHESIA FOR EMERGENCY C-SECTION FOR FETAL DISTRESS; AFTER SURGERY, THE DRAPE WAS PULLED OFF AND A CAUTERY BURN WAS NOTED ON THE UPPER LEFT QUADRANT. WHILE STILL UNDER GENERAL ANESTHESIA, THE BURNED AREA WAS EXCISED AND SUTURED. THE BOVIE WAS SENT TO BIOMED FOR TESTING; RESULTS BACK ON 9/23/96; DEVICE HEATING O.K.
THE CUSTOMER  WAS CONTATCED AND INDICATED THAT THE GENERATOR HAD BEEN TESTED BY THEIR BIOMEDICAL DEPARTMENT AND FOUND TO OPERATE PROPERLY AND RETURNED TO USE. THEY DO NOT WISH TO RETURN IT TO CO. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AS ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
LABELLING FOR THE BAND, WHICH IS USED WITH THE APPLICATOR, IDENTIFIES INSTANCES WHEN ADDITIONAL SURGERY MAY BE REQUIRED.
ON 10/4/96. THE FACILITY SURGICAL SERVICES MANAGER CONTACTED THE MFR AND REPORTED THAT THE DEVICE HAD BEEN REMOVED ON 10/3/96 AND THE SURGEON BELIEVES THE DEVICE CATHETER MAY BE DEFECTIVE. IT WAS ADDITTIONALLY STATED THAT THE DEVICE AND ATTACHED PIECE OF CATHETER ARE AVAILABLE FOR EVALUATION; HOWEVER, A SEGMENT OF CATHETER IS BELIEVED TO REMAIN INSIDE THE PT.
ON 10/11/96, THE DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS ALONG WITH AN EXPLANT FORM WHICH STATES THAT THE DEVICE WAS NOT FUNCTIONING CORRECTLY AND ALL PORTIONS WERE REMOVED FROM THE PT. THE DEVICE HAS BEEN ANALYZED AS FOLLOWS: THE DEVICE RECEIVED WAS CONSISTENT IN DESIGN WITH THE CATALOG NUMBER REPORTED, HOWEVER, THE CATHETER SEGMENT WAS NOT RECEIVED. THE DEVICE CATHETER WAS CUT CLOSE TO THE DEVICE BODY. THE DEVICE SEPTUM WAS PARTIALLY DISLODGED. SEVERAL NEEDLE PENETRATION MARKS WITH NO INTERNAL DAMAGE WERE SEEN ON THE SEPTUM. THE DEVICE WAS NOT PATENT AND READILY LEAKED FROM THE DISLODGED AREA OF THE DEVICE SEPTUM. MATERIAL WHICH TESTED POSITIVE FOR BLOOD WAS SEEN THROUGHOUT THE INTERNAL SURFACES OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMNILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE FACILITY'S REPORT OF A DEFECTIVE CATHETER IS INCONCLUSIVE SINCE THE DEVICE CATHETER WAS NOT RECEIVED. BASED ON THE INFO AVAILABLE, AND THE DEVICE ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT OR HOW THE DEVICE SEPTUM WAS DISLODGED. NO FURTHER INFO IS AVAILABLE. THE CUSTOMER WILL BE NOTIFIED OF THE MFR'S FINDINGS. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THIS EVENT WAS REPORTED AS LEAFLET DISRUPTION WITH REGURGITATION. NO FURTHER INFO PROVIDED.
THE GUIDEWIRE WAS USED THROUGH AN ENTRY NEEDLE. A PIECE OF THE WIRE DETACHED IN THE PT AND REMAINED IN THE LEFT PROFUNDA ARTERY. RETRIEVAL UTILIZING A SNARE WAS UNEVENTFUL.
CO RECEIVED THE ALLEGED DETACHED PIECE THAT HAD BEEN RETRIEVED FROM THE PT, AND VISUALLY EXAMINED IT. THE PIECE IS APPROX. 9.4 CM IN LENGTH. THE PIECE APPEARS TO BE A SEGMENT OF COATING THAT SHEARED FROM THE GUIDEWIRE. AS A CAUTION, IT IS INDICATED ON CO'S PACKAGE LABELING "TO AVOID DAMAGE AND POSSIBLE SHEARING OF THE PLASTIC, DO NOT WITHDRAW OR MANIPULATE THROUGH A METAL CANNULA/METAL DILATOR NOR ADVANCE THE METAL CANNULA/METAL DILATOR. EXTREME CAUTION SHOULD BE OBSERVED WHEN USED WITH A ONEWALL PUNCTURE STYLE NEEDLE." THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS OCCURRENCE.
A FEMALE PT REPORTED EXPERIENCING AN OCULAR BURNING SENSATION ABOUT 1 1/2 HOURS AFTER APPLICATIONS OF HER LENSES. SHE HAD PREVIOUSLY DISINFECTED HER LENSES USING THE 3% HYDROGEN PEROXIDE DISINFECTING SOLUTION (THE PT IS UNSURE IF SHE USED A NEUTRALIZING TABLET.). THE PT REMOVED HER LENSES AND RINSED HER EYES, HOWEVER, HER OCULAR IRRITATION PERSISTED SO SHE SOUGHT MEDICAL TREATMENT. SHE WAS EXAMINED AND THE PHYSICIAN REPORTEDLY DIAGNOSED A CORNEAL BURN AND PRESCRIBED BACITRACIN STERILE OPHTHALMIC OINTMENT FOR 3 DAYS, TO BE APPLIED ONCE DAILY AT NIGHT. THE MFR HAS BEEN UNABLE TO VERIFY MEDICAL TREATMENT WITH THE TREATING PHYSICIAN.
THIS EVENT WAS REPORTED AS LEAFLET ESCAPE AND DYSPNEA. NO FURTHER INFO PROVIDED.
THIS EVENT WAS REPORTED AS UNKNOWN. NO FURTHER INFO PROVIDED.
AN OPTOMETRIST REPORTED THAT A MALE PT HAD INCURRED AN ACANTHAMOEBA INFECTION. CO IS AWAITING ADD'L INFO FROM THE REPORTER.
ON 10/15/96, THE FACILITY CONTACTED A MFR REP WITH THE FOLLOWING INFO: THE PT REPORTED FOR HER REGULAR CHEMO REFILL ON 10/15/96. THE LAST REFILL TOOK PLACE ON 10/03/96, 12 DAYS PIROR. UPON ACCESSING THE DEVICE, THE RETURN VOLUME WAS FOUND TO BE 46CC. THE FACILITY NURSE THEN ACCESSED THE DEVICE SIDEPORT AND INITIATED THE DUAL SYRINGE UROKINASE FLUSHING TECHNIQUE AS DESCRIBED IN THE DEVICE CLINICIAN'S MANUAL WITH NO SUCCESS. THE OCCLUSION REMAINED INTACT AND THE PT WAS SENT HOME WITH PLANS TO RETURN THE NEXT MORNING. THE MFR REP ADVISED THE FACILITY NURSE TO TRY THE FLUSHING TECHNIQUE AGAIN AND TO REFILL THE DEVICE WITH 1000 U/ML HEPARINIZED SALINE. THE DEVICE WAS STATED TO HAVE BEEN IMPLANTED APPROX 9/13/96.
FURTHER COMMUNICATION, VIA A MFR. REP ON 10/22/96, REVEALED THAT THE PT HAD RETURNED THE FOLLOWING DAY, ON 10/16/96, THE DEVICE WAS REFILLED AND THE DUAL SYRINGE UROKINASE FLUSHING TECHNIQUE WAS ONCE AGAIN EMPLOYED TO NO AVAIL, THE DEVICE CATHETER APPEARED TO REMAIN OCCLUDED. THE DEVICE WAS REFILLED WITH 50ML HEPARINIZED SALINE AT 1000 UNITS PER ML AND THE PT WAS SENT HOME. IT WAS ADDITIONALLY STATED THAT ANOTHER FORM OF CHEMOTHERAPY HAD ALREADY BEEN STARTED AND IS NOT BEING USED WITH THE DEVICE. THE PT ALSO HAS NOTICEABLE EXTRA HEPATIC DISEASE NOW AND IS PROBABLY NOT A GOOD CANDIDATE FOR THE DEVICE. FURTHER COMMUNICATION VIA THE MFR. REP, ON 10/29/96, REVEALED THAT AS FAR AS HE KNOWS NOTHING HAS CHANGED SINCE 10/22/96 AND THE DEVICE IS STILL NOT BEING USED. IT WAS ADDITIONALLY STATED THAT THE PT HAS WHAT IS CONSIDERED A LOT OF EXTRA HEPATIC DISEASE AT THIS POINT AND THE FACILITY DECIDED TO DO SOMETHING SYSTEMIC RATHER THAN UTILIZE THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE FACILITY'S REPORT OF AN OCCLUSION OF THE DEVICE CATHETER IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING TH EFILE ON THIS EVENT.
PT RECEIVED BREAST IMPLANTS OF AN UNKNOWN MFR ON AN UNKNWON DATE. RPTR ALSO ALLEGES "ONE HAS STARTED TO HAVE A PROBLEM."
10/30/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
PT ALLEGES RECEIVING IMPLANTS IN 1991 OF AN UNKNOWN MFR. PT ALSO ALLEGES ONE OF HER IMPLANTS IS DEFLATED AND NEEDS TO HAVE REMOVED.
PLAINTIFF REPORTS BILATERAL IMPLANTATION 5/22/84 WITH EXPLANT 9/2/88. PLAINTIFF ALLEGES VARIOUS ILLNESSES, INCLUDING BUT NOT LIMITED TO, SCLERODERMA, RHEUMATOID ARTHRITIS, AND CHRONIC FATIGUE.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CORPORATION CEASED MFR AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACSUISITION OF CO IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
THE CATHETER SHAFT WAS SEVERED DURING A CONTRALATERAL SFA. THE DISTAL SEGMENT OF THE CATHETER DETACHED IN THE PT AND WAS SURGICALLY REMOVED WITHOUT PT COMPLICATIONS. THIS DEVICE WAS DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. FOLLOW-UP REVEALED THE PT'S DISEASED ARTERIES WERE SO CALCIFIED THE CATHETER TORE AND WAS SEVERED BY THE CALCIFICATION DURING WITHDRAWAL OF THE CATHETER POST PROCEDURE. THEREFORE, CO BELIEVES PT CONDITION CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE.
THIS EVENT WAS RUPTURED AS REGURGITATION. NO FURTHER INFO PROVIDED.
PT RECEIVED BREAST IMPLANTS ON AN UNKNOWN DATE AND IS SCHEDULED FOR REMOVAL AND REPLACEMENTS ON 11/26/96 DUE TO RUPTURED IMPLANTS.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 1/5/77. PT ALSO ALLEGES HAVING LEAKING IMPLANTS IN 7/90. PHYSICIAN'S NOTE STATES LEAKING LEFT SILICONE GEL BREAST IMPLANT AND POSSIBLE LEAKING RIGHT SILICONE GEL BREAST IMPLANT.
A LACERATION OF THE SMALL BOWEL MESENTERY OCCURRED ALLEGEDLY DURING INSERTION OF TROCAR FOR LAPAROSCOPIC PROCEDURE. EXPLORATORY LAPAROTOMY WITH REPAIR OF MESENTERIC ARTERY AND MULTIPLE BLOOD TRANSFUSIONS REQUIRED TO TREAT VESSEL INJURY. PT DISCHARGED ON THE SIXTH POST OPERATIVE DAY WITHOUT FURTHER COMPLICATIONS. THE DEVICE WAS DISCARDED.
A FILTER PLACED IN 1990 MIGRATED AND TWO FILTER LEGS PENETRATED THE DUODENUM. THE TWO LEGS WERE SURGICALLY REMOVED AND THE FILTER REMAINS IMPLANTED. THE PHYSICIAN FEELS THE PT IS PROTECTED AND IS NOT PLANNING ANY FURTHER ACTION. ATTEMPTS TO DETERMINE THE CATALOG NUMBER OR FILTER TYPE HAVE BEEN UNSUCCESSFUL. THIS DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE.
PT ALLEGES RECEIVING IMPLANTS ON 2/9/77. DOCTOR STATES "I HAVE NOT PERSONALLY SEEN THIS PT, BUT MY COLLEAGUE HAS ON THE 26TH OF JULY 1994, WHO STATED AT THE TIME, POSSIBILITY OF RUPTURE EXISTED WITH THE ADVANCING AGE OF THE PROSTHESES AND THAT HE WOULD OFFER HER REMOVAL."
CALLER STATES THAT THREE DRESSINGS WERE USED ON THIS PT THAT HAD VENOUS ULCERS APPROX 95% HEALED. THESE WERE ON THE LEFT LOWER LEG, MEDIAL AND LATERAL. DRESSING CHANGES WERE BEING PERFORMED TWICE A WEEK WITH ANOTHER DRESSING AND A BOOT BEFORE SWITCHING TO DEVICE. CALLER STATES THAT THE WOUND HAD NO INFECTION PRIOR TO USING DEVICE. THE WOUNDS WERE CLEANED WITH NS AND DEVICE WAS APPLIED. A BOOT WAS APPLIED, THIS WAS ON TUESDAY. ON FRIDAY THEY REMOVED THE DRESSINGS TO FIND THAT THE WOUNDS WERE "DRAINING LARGE AMOUNTS OF PURULENT DRAINAGE WITH BLOOD IN THE DRAINAGE. THE WOUND EDGES WERE DARK. CULTURES WERE TAKEN OF THE WOUNDS WITH THE RESULTS DUE TUESDAY. THE PT HAS BEEN PUT ON PO CIPRO 500 MG BID."
NO SAMPLE WAS RETURNED FROM THE COMPLAINT. NO SIMILAR COMPLAINTS HAVE BEEN NOTED FOR THIS LOT NUMBER. QUALITY RECORDS WERE REVIEWED AND NO NONCONFORMANCES OF THIS TYPE WERE NOTED. NO CORRECTIVE ACTION IS CONSIDERED NECESSARY AND NONE WILL BE TAKEN. TRENDS OF COMPLAINTS SHALL CONTINUE TO BE MONITORED.
PT ALLEGES RECEIVING A BREAST IMPLANT OF AN UNKNOWN DATE. PT ALLEGES SHE HAS, "SUFFERED SERIOUS MEDICAL COMPLICATIONS RESULTING FROM A BREAST IMPLANT OPERATION PERFORMED USING CO'S SUPPLIES WHICH WAS A SUBSEQUENTLY REMOVED" ON AN UNKNOWN DATE.
NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1974. PT ALSO ALLEGES HAVING LEAKAGE SYMPTOMS BEGINNING IN 1994. PHYSICIAN'S NOTE STATES BILATERAL ENCAPSULATION. PT PLANS TO HAVE REMOVAL.
DURING A ROUTINE INTERROGATION OF THE ICD ON 10/1/96, AN ERROR MESSAGE APPEARED ON THE PROGRAMMER SCREEN INDICATING THAT THE ICD CRYSTAL HAD STOPPED RUNNING AND THAT THE DATE AND TIMES REPORTED BY THE ICD COULD BE INACCURATE. SURGERY WAS PERFORMED ON 10/2/96 TO EXPLANT THE ICD.
THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY CO. H3 EVAL SUMMARY THE ERROR MESSAGE WAS CAUSED BY A RANDOM FAILURE OF THE CLOCK CRYSTAL AND THE RESULTING WEAK CRYSTAL SIGNAL. BASIC DEVICE FUNCTIONALITY WAS NOT AFFECTED BY THE FAILURE DURING TESTING.
THE CATHETER PORTION OF THE DEVICE DISCONNECTED FROM THE PORT OUTLET TUBE AND MIGRATED INTO THE PT'S HEART. AN INTERVENTIONAL RADIOLOGIST REMOVED THE CATHETER FROM THE PT'S HEART WITH NO COMPLICATIONS. THE HOSPITAL DISCARDED THE PRODUCT. IT IS CO'S OPINION, BASED ON ITS INVESTIGATION OF THIS INCIDENT, THAT THE PHYSICIAN PROBABLY FAILED TO ENGAGE THE LOCKING COLLAR COMPLETELY, THUS NOT SECURING THE CATHETER TO THE PORT.
PLAINTIFF RECEIVED IMPLANTS ON AN UNKNOWN DATE, AND OF AN UNKNOWN MFR. ATTORNEY ALLEGES PLAINTIFF HAS HAD IMPLANT PROBLEMS, HOWEVER, NO SPECIFICS WERE GIVEN.
68A NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN.
A BALLOON RUPTURED AT APPROX SIX ATM DURING DILATION OF A THROMBOSED PREVIOUSLY PLACED STENT IN THE SUBCLAVIAN VEIN. UPON WITHDRAWAL OF THE BALLOON CATHETER, RESISTANCE WAS MET. IT WAS BELIEVED THE BALLOON WAS HUNG UP IN THE STENT. AN INTRODUCER SHEATH WAS ADVANCED INTO THE STENT IN AN EFFORT TO REMOVE THE BALLOON CATHETER. CONTINUAL RESISTANCE WAS ENCOUNTERED AGAINST EXERTION AND RESULTED IN FRACTURING THE CATHETER SHAFT. THE DETACHED SEGMENT WAS REMOVED UTILIZING A SNARE BY WITHDRAWING THE SNARE, CATHETER SEGMENT, SHEATH, AND GUIDEWIRE AS A UNIT. HOWEVER, DAMAGE TO THE CEPHALIC VEIN WAS NOTED UPON RETRIEVAL. REPAIR OF THE DAMAGED VEIN WAS COMPLETED WITH A STENT. THE PT'S CONDITION IS GOOD. THE DEVICE WAS DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. IT WAS INDICATED THIS DEVICE WAS USED TO DILATE AN EXISTING STENT. IT WAS ALSO INDICATED CONTINUAL EXERTION WAS APPLIED AGAINST RESISTANCE. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: BALLOON DILATION CATHETERS ARE RECOMMENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF NARROWED SEGMENTS IN THE ILIAC AND FEMORAL ARTERIES IN THE PERIPHERAL VASCULATURE. ANY USE FOR PROCEDURES OTHER THAN THOSE INDICATED IN THESE INSTRUCTIONS IS NOT RECOMMENDED. IF RESISTANCE IS FELT WHEN REMOVING A GUIDE WIRE THROUGH AN INTRODUCER SHEATH, STOP AND REMOVE THEM AS A COMPLETE UNIT TO PREVENT DAMAGE TO THE GUIDEWIRE, CATHETER OR VESSEL."
PT ALLEGES RECEIVING BREAST IMPLANTS ON 7/3/70. PT ALSO ALLEGES SHE EXPERIENCED NO PROBLEMS; HOWEVER, SHE HAD A CYST REMOVED ON 8/20/87. PHYSICIAN'S NOTE STATES SOFT CONSISTENCY OF BREASTS AND CT SCAN SUGGESTS POSSIBLE RUPTURE OF IMPLANTS. PT PLAN TO HAVE REMOVAL.
D6 - LOT NUMBER PROVIDED (HH0600) HAS A DIFFERENT CATALOG NUMBER THAN WHAT WAS PROVIDED AND THE MFR DATE FOR THIS DEVICE LOT IS FOUR YEARS PAST THE PT'S IMPLANT DATE. LOT NUMBER H0600 HAS THE CATALOG NUMBER WHICH WAS PROVIDED AND THE MFR DATE IS CONSISTENT WITH THE PT'S IMPLANT DATE.
PT ALLEGED RECEIVING IMPLANTS IN 1978. PT ALSO ALLEGES HAVING NOTHING BUT TROUBLE WITH THEM SINCE TWELVE MONTHS (I.E. 1979) AFTER THEY WERE PUT IN; HOWEVER, NO SPECIFICS WERE GIVEN.
2203 OTHER NO HEALTH CARE PROFESSIONAL HAS ALLEGED ANY PROBLEM WITH THE DEVICE.
THE PT WAS ADMITTED TO A LONG TERM CARE FACILITY ON 9/16/96, IN A TERMINAL CONDITION. PT WAS RECEIVING MORPHINE IV THE PUMP AT A RATE OF 0.2 ML/HR, CONCENTRATION WAS 1 MG/ML. INFUSION WAS INITIATED AT 2300 HRS ON 9/16/96. EXACT TIME NOT PROVIDED, AND PT'S SON IS CLAIMING THE DEATH WAS DUE TO AN OVERINFUSION VIA THE PUMP. THE PHARMACIST FROM THE FACILITY SUPPLYING THE PUMP AND MEDICATION, FELT THAT THE PUMP WAS INFUSION AT THE PROGRAMMED RATE AS SHE RECALLS NURSING PERSONNEL CALLING THE PHARMACY SEVERAL TIMES STATING THE RESIDUAL VOLUME SCREEN WAS NOT SHOWING THE VOLUME GOING DOWN. AT THE RATE PROGRAMMED IT WOULD TAKE 5 HRS FOR THE SCREEN TO REGISTER A LML DECREASE. THE PT'S BODY WAS RELEASED TO A FUNERAL HOME AFTER HER DEATH AND ACCORDING TO THE ADMINISTRATOR OF THE CARE FACILITY THERE WERE NO ARRANGEMENTS TO PERFORM AN AUTOPSY. THE ADMINISTOR STATED THE PT'S SON CLAIMED THERE WAS AN AUTOPSY, AND THE SON HAD IT ARRANGED TO DO AN INDEPENDENT AUTOPSY BUT NO REPORT OF THE FINDINGS WERE GIVEN BY THE SON. IT WAS REPORTED THAT THE DEATH CERTIFICATE, WHICH HAD ORIGINALLY BEEN LEFT BLANK, NOW READ DEATH DUE TO ARTERIOSCLEROTIC AND VALVULAR HEART DISEASE. ALTHOUGH NO HEALTH CARE PROFESSIONAL HAS ALLEGED THE DEATH WAS DUE TO AN OVERINFUSION, IT WAS DECIDED BY ALL MEDICAL PARTIES INVOLVED THAT THE PUMP BE TESTED AT AN INDEPENDENT FACILITY.
WHEN 300 JOULES OF DEFIBRILLATOR WHEN SUBSEQUENTLY DELIVERED TO THE PT IT WAS REPORTED THAT A LOUD POP WAS HEARD TOGETHER WITH A BRIGHT FLASH AND A BURNING SMELL.
THE LOCAL SERVICE REP OBSERVED PROPER DEVICE OPERATION BUT DURING AN INTERNAL INSPECTION OBSERVED EXCESSIVE INTERNAL ARCING AND FAILURE OF RELAY, K2, ON THE DEFIB MAIN PCB ASSEMBLY, WHEN THE DEFIBRILLATOR WAS DISCHARGED. THE ASSEMBLY WAS REPLACED AND PROPER OPERATION OF THE DEVICE WAS THEN OBSERVED, THROUGH FULL FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA.
THIS EVENT WAS REPORTED AS REGURGITATION, HEMODYNAMICS, PERFUSION AND MYOCARDIAL INFARCTION. NO FURTHER INFO PROVIDED.
F1: USER FACILITY. PT CODE: 2259, 2203=HEMODYNAMICS, PERFUSION. 1783,1908 PULMONARY.
COMPLAINANT STATES THAT THE BEARING INSERT COMPONENT OF THE KNEE TIBIAL PROSTHESIS BROKE. THERE WAS NO EVIDENCE OR SYMPTOMS PRIOR TO THIS EVENT. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO COMTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISISON OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES.
PT ALLEGES RECEIVING IMPLANTS IN 1990. PT ALSO ALLEGES SHE HAS SHARP PAIN IN HER BREASTS AND ARMPIT AREA.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED A PORTION OF THE COLON TO POSITION THE DEVICE. THE HOSPITAL HAS REPORTED THAT THE PT'S CONDITION IS STABLE.
11/21/96-SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6. ADDITIONAL DATA ENTERED IN D9. CORRECTED DAA ENTERED IN G4.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 10/28/81. PT ALSO ALLEGES EXPERIENCING PROBLEMS BEGINNING IN APPROX 1992, INCLUDING CHRONIC FATIGUE, TINGLING "PINS AND NEEDLES", NUMBNESS AND RHEUMATIC SYNDROME. PT ALSO ALLEGES A LUMP, LOW PLATELETS AND A RUPTURED IMPLANT IN 1993. PT HAD REMOVAL OF HER RIGHT IMPLANT ON 3/2/93 AND REMOVAL OF HER LEFT IMPLANT ON 2/2/94. PHYSICIAN'S NOTE CONFIRMS PT'S RIGHT PROSTHESIS WAS RUPTURED WITH AN ASSOCIATED SILICONE GRANULOMA AND THAT PT'S LEFT IMPLANT WAS REMOVED FOR SYMMETRY.
THE INITIAL REPORT INDICATED THAT THE PRODUCT WAS RETURNED. HOWEVER, THE PRODUCT THAT WAS RETURNED WAS ANOTHER VALVE, NOT THIS VALVE. PLEASE REFER TO REPORT NUMBER 2021898-1996-00075.
PT RECEIVED IMPLANTS IN 7/81. RPTR ALSO ALLEGES THAT PT HAD A "BURST" IMPLANT IN 4/94. PT HAD REMOVAL OF IMPLANTS ON 4/23/96 AND RECEIVED REPLACEMENTS OF ANOTHER MFR. PHYSICIAN STATES "LEAKAGE OF GEL IMPLANT ON THE RIGHT."
DEVICE WAS RETURNED FOR ID PURPOSE ONLY, NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN.
A FEMALE PT WHO IS A RN REPORTED EXPERIENCING AN OCULAR BURNING SENSATION, REDNESS AND IRRITATION AFTER USING DISINFECTING SOLUTION AND FAILING TO USE NEUTRALIZER. SHE REMOVED HER LENSES AND FLUSHED HER EYES WITH WATER AND THEN APPLIED A COLD COMPRESS. THE PT DID NOT WEAR HER LENSES THAT DAY. IT WAS RECOMMENDED THAT SHE CONTACT HER DR FOR EVALUATION. IN FOLLOW-UP WITH PT, SHE REPORTEDLY SOUGHT MEDICAL TREATMENT FROM AN EYE CLINIC. PT WAS DIAGNOSED WITH KARETITIS AND PRESCRIBED TOBRAMYCIN FOR 2 DAYS. IN FOLLOW-UP WITH THE DR, IT WAS INDICATED THAT MEDICATION WAS NOT GIVEN AS ROUTINE TREATMENT.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1980. PT ALSO ALLEGES IN 1986 SHE DEVELOPED CHEST PAIN AND IN 1990 SHE HAD HARDENING OF HER IMPLANTS; THEREFORE, SHE HAD REMOVAL IN JUNE, 1994. PHYSICIAN STATES PT HAD CAPSULE BILATERALLY.
THE DEVICE WAS IMPLANTED ON 4/19/95, FOR ARTERIAL INFUSION OF FUDR FOR TREATMENT OF CANCER. ON 10/4/96, THE MFR RECEIVED THE FOLLOWING RESPONSE TO A DEVICE TRACKING POLLING LETTER WHICH STATED THE FOLLOWING: "CHEMO DISCONTINUED, PT NO LONGER NEEDED IT. ADDITIONALLY, THE PT WAS DEVELOPING CELLULITIS IN THE ABDOMINAL WALL SECONDARY TO THE DEVICE." THE DEVICE WAS EXPLANTED IN 2/96 AND THE PT PASSED AWAY IN 3/96.
ON 10/29/96, A MFR REP WAS INFORMED BY THE EXPLANTING PHYSICIAN'S OFFICE MGR THAT TO HER KNOWLEDGE, THIS EVENT WAS NOT RELATED TO THE DEVICE OR A DEVICE MALFUNCTION. THE DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS; THEREFORE, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CAT NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT FOR THIS DEVICE. BASED ON THE INFO AVAILABLE, THIS EVENT DOES NOT APPEAR TO BE DUE TO THE DEVICE OR A DEVICE MALFUNCTON; HOWEVER, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. NO FURTHER DETAILS ARE AVAILABLE. THE CUSTOMER WILL BE NOTIFIED OF THE MFR'S FINDINGS. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
NO ADD'L INFO HAS BEEN RECEIVED FROM THE USER FACILITY DESPITE REQUEST. THE RETURNED LENS WAS VERIFIED TO HAVE ONE BROKEN HAPTIC IN THE GUSSET AREA. EVIDENCE OF BLOOD AND CLINICAL SOLUTION WAS NOTED ON THE LENS SURFACE INDICATING CUSTOMER HANDLING. INFO SUPPLIED IN SECTION F WAS PROVIDED BY THE MFR, NOT THE USER FACILITY. THIS REPORT WAS MAILED IN TO FDA ON: 11/1/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED-1.
ADDITIONAL INFORMATION FROM SURGEON REPORTS THAT EVENT WAS UNRELATED TO THE LENS. THE POSTERIOR CAPSULAR INTEGRITY WAS LOST DURING THE PHACOEMUSLIFICATION PROCEDURE. THE LENS WAS PLACED IN THE CILIARY SULCUS BUT IT BEGAN TO SINK SO IT WAS WITHDRAWN. AT THIS TIME THE HAPTIC WAS BENT AND SUBSEQUENTLY BROKE OFF BUT SURGEON REPORTS IT WAS STRESSED BEYOND REASON UNDER AN UNPHYSIOLOGIC SITUATION. AN ANTERIOR CHAMBER LENS WAS PLACED IN THE EYE.
HOSP IS LOOKING FOR PRODUCT. CODES IN SECTION F ARE COVERED IN PRODUCT LABELING.
PHYSICIAN'S NOTE SHOWS PT RECEIVED BREAST IMPLANTS ON 5/16/79. IN 8/95, PT HAD DEFLATION OF LEFT IMPLANT; THERFORE, ON 9/4/96 PT HAD EXCISION OF THE DEFLATED LEFT AND INTACT RIGHT IMPLANTS.
METHOD: 86C DIMENSIONAL MEASUREMENT; 86D MICROSCOPIC EXAMINATION. RESULTS: 100A LOSS OF SHELL INTEGRITY, ENVELOPE SLIT; 100B CREASE LINES; 100C SLIGHT AMBER COLOR; 100E FOREIGN MATERIAL; 100H LOSS OF SHELL INTEGRITY, EVELOPE TEAR. DEVICE 1 OF 2 CONCLUSIONS: 68 FOREIGN MATERIAL LIKELY RESIDUAL SALINE; SLIT CAUSED BY SHARP OBJECT CONTACT; COLOR WITHIN SPECIFICATIONS; CREASES AND WEAR RESULT OF FOLDING ACTION IN-VIVO. DEVICE 2 OF 2 CONCLUSIONS: 68 FOREIGN MATERIAL LIKELY RESIDUAL SALINE; CAUSE OF TEAR UNDETERMINED; COLOR WITHIN SPECIFICATIONS.
METHOD: 86C DIMENSIONAL MEASUREMENT; 86D MICROSCOPIC EXAMINATION. RESULTS: 100A LOSS OF SHELL INTEGRITY, ENVELOPE SLIT; 100B CREASE LINES; 100C SLIGHT AMBER COLOR; 100E FOREIGN MATERIAL; 100H LOSS OF SHELL INTEGRITY, ENVELOP TEAR. DEVICE 1 OF 2 CONCLUSIONS: 68 FOREIGN MATERIAL LIKELY RESIDUAL SALINE; SLIT CAUSED BY SHARP OBJECT CONTACT; COLOR WITHIN SPECIFICATIONS; CREASES AND WEAR RESULT OF FOLDING ACTION IN-VIVO. DEVICE 2 OF 2 CONCLUSIONS: 68 FOREIGN MATERIAL LIKELY RESIDUAL SALINE; CAUSE OF TEAR UNDETERMINED; COLOR WITHIN SPECIFICATIONS.
PT ALLEGES RECEIVING IMPLANTS ON 7/8/86. PT ALSO ALLEGES SHE EXPERIENCED PROBLEMS IN MARCH 1996, INCLUDING HARDENING AND PAIN IN THE RIGHT BREAST.
PHYSCIAN'S NOTE SHOWS PT RECEIVED BREAST IMPLANTS ON 8/20/80. PT HAD BILATERAL REMOVAL OF IMPLANTS ON 7/26/95 DUE TO DEFLATION OF RIGHT IMPLANT.
A MALE PT EXPERIENCED A RECURRING EYE INFECTION AFTER USING CLEANING AND SOAKING SOLUTION. THE PT SOUGHT MEDICAL TREATMENT AND SULFACETAMIDE SODIUM WAS PRESCRIBED ON 2 SEPARATE OCCASIONS. ADDITIONAL ANTIBIOTIC THERAPY (GENTAMICIN) WAS ALSO GIVEN. IT WAS NOTED THAT THE PT HAD NO HISTORY OF ALLERGIES. IN FOLLOW-UP WITH THE EYE CARE PRACTITIONER, THE DR NOTED THAT THE PT REPORTED SYMPTOMS OF AN OCULAR BURNING SENSATION AND ITCHINESS; AN EYE INFECTION WAS NOT DIAGNOSED. IN THE ABSENCE OF ANY CLEAR STATEMENT FROM THE DR, THE SPONSOR IS REPORTING THIS EVENT BECAUSE OF THE POSSIBILITY THAT TREATMENT WAS REQUIRED TO PRECLUDE A PERMANENT INJURY.
THE PRODUCT WAS RETURNED AND EVALUATED BY CO. THE EVAL INCLUDED A VISUAL EXAMINATION AND TESTING FOR PATENCY, PRESSURE/FLOW CHARACTERISTICS, PREIMPLANTATION PRESSURE AND SIPHONING. A BLOOD-LIKE MATERIAL WAS PRESENT IN THE INLET OCCLUDER AREA, MAIN DOME AREA, MEMBRANE CASING/SEAT AREAS IN-BETWEEN THE REIN-FORCED SHEETING AND THE BASE. THERE WAS A CLEAR RESIDUE ON BOHT UPPER AND LOWER MEMBRANE SEAT AREAS OF THE DELTA SIPHON CONTROL. THE PRODUCT MET CO MEDICAL SPECIFICATIONS FOR PRESSURE/FLOW. THE PRESENCE OF THE BLOOD-LIKE MATERIAL UNDER THE MEMBRANE SEAT AREA IS LIKELY TO HAVE CAUSED THE LOW PRESSURE/FLOW VALUES.
THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. DEVICE WAS FIRED ACROSS THE MESOAPPENDIX. STAPLES WERE DELIVERED WITH STRAIGHT LEGS AND THE DEVICE CUT. UPON FURTHER DISCUSSION, IT APPEARS THAT THE CARTRIDGE MAY NOT HAVE BEEN SEALED PROPERLY IN THE DEVICE. THE CARTRIDGE FELL ONTO THE FLOOR WHEN THE DEVICE WAS REMOVED FROM THE TROCAR.
PT ALLEGES RECEIVING THE LEFT IMPLANT ON 11/15/89. PT ALSO ALLEGES WITHIN THE FIRST 18 MONTHS (I.E. 1991), SHE EXPIERENCED PAINFUL NIPPLE, UNCOMFORTABLE TIGHTNESS OF THE BREAST, AND IN THE PAST TWO YEARS THE BREAST HAS BECOME MISSHAPED AND VERY LUMPY. DOCTOR ALLEGES CAPSULE CONTRACTURE OF THE LEFT BREAST AND CONCERN WITH SILICONE ISSUE.
PT ALLEGES RECEIVING IMPLANTS ON 8/11/87. PT ALSO ALLEGES SHE EXPERIENCED PROBLEMS WITH HER BREAST IMPLANTS BEGINNING ON 9/1/93 ON DIFFERENT OCCASIONS, INCLUDING HARDNESS, PAIN AND WORRY. DOCTOR ALLEGES RIGHT BREAST CAPSULE FORMATION.
A PT EXPERIENCED A CORNEAL ABSCESS AFTER USING SOLUTION. APPARENTLY THE PT HAD LOST HER CONTACT LENS CASE AND HAD RE-USED AN OLD CASE. IT WAS FELT THAT THIS WAS THE BASIS OF THE INCIDENT. A CULTURE OF THE LENS CASE ISOLATED STAPHYLOCOCCUS HAEMOLYTICUS. THE PT WAS REPORTEDLY HOSPITALIZED FOR 7 DAYS AND TREATED WITH GENTALLINE AND FIRTUM (CEFTAZIDIME). THE SPONSOR CONSIDERS THAT ANY RELATIONSHIP OF THE EVENT TO THE ACTUAL PRODUCT TO BE UNLIKELY.
DURING A TURP PROCEDURE, THE IRRIGATION PUMP TUBING WAS PUT ON IMPROPERLY. THE SITUATION WAS NOT NOTED FOR 15 MINUTES. PT DIED OF HYPONATREMIA 7 HR LATER.
HOSP'S BIO-MED HAS EVALUATED THE SUBJECT PUMP AND FOUND IT TO BE FUNCTIONING PROPERLY.
CONFIRMED RUPTURE OF RIGHT BREAST IMPLANT AFTER REMOVAL OF SILICONOMAS. LEFT BREAST IMPLANT NOT RUPTURED BUT REMOVED WITH RELEASE OF CONTRACTURE.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. POST EXPLANT THE PHYSICIAN NOTED THE LEAD TO BE FRACTURED WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 4/30/90. PT ALSO ALLEGES EXPERIENCING HARDENING BEGINNING IN LATE 1990 AND HAVING A PROCEDURE PERFORMED ON 9/30/92 FOR CAPSULAR CONTRACTURE. PHYSICIAN'S NOTE STATES "CAPSULE CONTRACTION WITH EXCESSIVE FIRMNESS; PAIN, ESPECIALLY ON LEFT SIDE; CONCERN ABOUT POTENTIAL DELETRIOUS EFFECTS OF GEL BLEED OR GEL LEAK; LOCAL DISCOMFORT IN CHEST, SHOULDERS AND ARMS." PT PLANS TO HAVE REMOVAL.
PT HAD TOTAL KNEE 5/6/95. PT COMPLAINED OF PAIN. COMPONENTS LOOSE.
THE DISPOSABLE LOADING UNIT WAS USED WITH CO'S STAINLESS STEEL INSTRUMENT DURING A LOW ANTERIOR RESECTION. REPORTEDLY, DIFFICULTY WAS EXPERIENCED IN SEATING THE RETAINING PIN WHICH SUBSEQUENTLY RESULTED IN MALFORMED STAPLES. THE SURGEON PERFORMED A COLOSTOMY TO CORRECT THE CONDITION.
THIS 12.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE RIGHT EYE OF A FEMALE PT ON 9/17/96. THE DR NOTED SIGNIFICANT REFRACTIVE ERROR, REMOVED THE FIRST LENS AND IMPLANTED A 22.5 DIOPTER REPLACEMENT LENS ON 9/27/96. THE PT CURRENTLY ENJOYS 20/20 VISUAL ACUITY, AND THE DR REPORTS THE PROGNOSIS FOR HER VISION IS "GOOD." EXPIRATION DATE 12/2000.
EVALUATION: THE LENS WAS RECEIVED IN AN INJECTION MOLDED LENSTRAY (1 I) AND (#2) CAP. THE ENTIRE LENSTRAY ASSEMBLY WAS SOAKING IN AN UNKNOWN SOLUTION INSIDE A SPECIMEN CUP. THE CUP WAS SEALED INSIDE TWO ZIPLOCK PLASTIC BAGS. EDGE: ACCEPTABLE. OPTIC: HEAVY TRACES OF AN UNKNOWN SUBSTANCE WERE NOTED ON THE LARGE AND SMALL CONVEX. STAKING: NA. LOOPS: BOTH LOOPS WERE SLIGHTLY PULLED INWARDS CAUSING THEM TO BE SHORT. DIAMETRAL LENGTH: THE OPTIC WAS ACCEPTABLE, HOWEVER, BOTH LOOPS WERE SHORT. VAULT: ACCEPTABLE. DIOPTER: 12.35=12.5 ACCEPTABLE 10/28/96 AFTERNOON.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 10/7/82. PT ALSO ALLEGES ON 9/15/93 SHE DEVELOPED HARDENING. PHYSICIAN STATES THE PT HAS TENDERNESS, HARDNESS AND POSSIBLE RUPTURE OF SILICONE PROSTHESIS.
A DAUGHTER REPORTED THAT HER MOTHER EXPERIENCED AN OCULAR CHEMICAL BURN, IRRITATION, TEARING, AND OCULAR PAIN AFTER USING CLEANING AND SOAKING SOLUTION OF HARD LENSES ON HER GAS PERMEABLE LENSES. THEY FELT THAT THE LABELING WAS NOT CLEAR REGARDING ITS USE WITH HARD LENSES ONLY. IN FOLLOWUP WITH THE OPHTHALMOLOGIST'S OFFICE, THE DIAGNOSIS OF CHEMICAL BURNS WAS CONFIRMED, WITH CORNEAL EDEMA AND STAINING NOTED. PT WAS TREATED WITH TOBRADEX AND OCUFEN AND HAS RECOVERED. THE ATTENDING PHYSICIAN'S OFFICE STATED THAT THE EVENT WAS PROBABLY RELATED TO THE USE OF THE PRODUCT, AND MEDICAL TREATMENT GIVEN WAS TO PRECLUDE PERMANENT INJURY.
COMPLAINT SAMPLE USED IN REPORTED ADVERSE EVENT WAS FOUND TO MEET PRODUCT SPECIFICATIONS.
THE DEVICE WAS USED DURING A HEMICOLECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED ADDITIONAL TISSUE TO COMPLETE THE PROCEDURE. THE HOSP HAS STATED THAT THE PT'S STATUS IS SATISFACTORY.
PT ALLEGES RECEIVING A RIGHT BREAST IMPLANT ON 2/8/91 AS A REPLACEMENT. PT ALSO ALLEGES HAVING AN INTRACAPSULAR RUPTURE OF RIGHT BREAST IN 1994-1995. SHE ALSO ALLEGES HAVING A SCAN OF RIGHT BREAST ON 6/29/95 WHICH SHOWED INTRACAPSULAR PROSTHESIS AND THE DOCTOR SAID THE IMPLANT HAD SHRIVELED UP FROM THE INSIDE OUT AND NOW THE RIGHT BREAST IS BADLY MISSHAPED AND PAINFUL. PHYSICIAN'S NOTE STATES CAPSULE FORMATION AND RUPTURED IMPLANTS. PT PLANS TO HAVE REMOVAL. REFERENCE MW072615.
THE CATHETER BROKE OFF IN THE PT AT THE TIME OF INSERTION. THE PHYSICIAN WAS USING A 16 GAUGE BREAKAWAY NEEDLE TO INSERT THE CATHETER. THE CATHETER FRAGMENT WAS RETRIEVED FROM THE PT IN THE OR.
THE CATHETER WAS RETURNED IN TWO FRAGMENTS. THE PROXIMAL END OF THE CATHETER WAS INSERTED INTO A WINGED PEEL-APART INTRODUCER NEEDLE MADE BY ANOTHER MFR. THE CATHETER BODY WAS SHEARED BY A LONGCUT RUNNING THE LENGTH OF THE CATHETER BODY, WHICH ENDED IN A BREAK AT THE 2 DOT DEPTH MARKER. UNDER MAGNIFICATION, THE LENGTH OF THE PARED SURFACE WAS NICKED AND SLICED. THIS INDICATES THAT THE DAMAGE WAS PROBABLY CAUSED BY THE SHARP NEEDLE EDGE. THE USE OF SUCH AN INTRODUCER IS NOT RECOMMENDED DUE TO THE DELICATE NATURE OF SILICONE TUBING.
THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE. REPORTEDLY, THE STAPLE LINE WAS INCOMPLETE WHEN THE APPENDIX WAS RESECTED. THE SURGEON HAD TO RESECT ADD'L TISSUE TO COMPLETE THE PROCEDURE.
PT RECEIVED IMPLANTS ON 11/6/69. REPORT ALSO ALLEGES SHE RECEIVED BREAST IMPLANTS AT AGE 21 AND BECAME ILL FOR MANY YEARS. SHE WAS ABLE TO WORK UNTIL RECENTLY WHEN SHE BECAME ILL THAT SHE WAS HOSPITALIZED TWICE AND DIAGNOSED WITH DERMATOMYOSITIS AND POLYMYOSITIS. THIS WAS ASSESSED BY MUSCLE BIOPSY REPORTS OF MYOSITIS AND BY SERUM LEVELS THAT WERE TOO HIGH. PT STATES SHE DEVELOPED EXTREME FATIGUE, RASHES, MUSCLE WEAKNESS AND REPORT SHOWED RUPTURE OF AN IMPLANT. PT HAD REMOVAL IN 3/86 AND SHE IS UNCERTAIN IF SILICONE CAUSED HER CURRENT AND PAST ILLNESS, BUT SHE BELIEVES IT DID. PHYSICIAN'S LETTER STATES THE PT DEVELOPED AN UNUSUALLY HIGH FEVER TO 103 DEGREES, SEVERE MYALGIA AND WAS HOSPITALIZED FOR ABOUT TEN DAYS AND THE ONLY DIAGNOSIS DETERMINED WAS A COLLAGEN VASCULAR DISEASE AND FEBRILE ILLNESS POSSIBLY RELATED SINCE NO DEFINITE CAUSATIVE ORGANISM WAS FOUND.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1986. PT ALSO ALLEGES IN 1986 SHE DEVELOPED LOSS OF NIPPLE SENSATION AND IN 1987 SHE STARTED TO EXPERIENCE HARDENING IN BOTH BREASTS AND CONSTANT SHARP PAIN, SEVERE HARDNESS AND FIRMNESS IN HER RIGHT BREAST. PHYSICIAN ALLEGES PT DEVELOPED SEVERE CONTRACTURE ON BOTH SIDES, DISTORTION OF BREAST SHAPE AND PAIN IN HER RIGHT BREAST, ESPECIALLY DURING MENSES.
A REPORT WAS FORWARDED TO CO FROM A RETAIL CHAIN STATING THAT A FEMALE PT EXPRESSED A "COMPLAINT" ON MULTI-PURPOSE SOLUTION. IN FOLLOW-UP, THE PT'S OPTOMETRIST REPORTED THAT THE PT WAS DIAGNOSED WITH SEVERE CHEMOSIS AND CORNEAL EDEMA WITH 80% OF THE CORNEAL EPITHELIUM ERODED. THE ATTENDING OPTOMETRIST STATED THAT TREATMENT WAS GIVEN TO PRECLUDE PERMANENT INJURY. PT WAS PARCHED OU AND TREATED WITH VASOCIDIN OINMENT, TYLENOL 3, MUROL 128, AND POLYMYXIN B.
DEVICE EVALUATED MET STABILITY SPECIFICATIONS FOR THIS PRODUCT.
PAINFUL RIGHT KNEE, EXCESSIVE WEARING AND TEARING OF THE POLYETHYLENE TIBIAL INSERT RIGHT KNEE.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 10/26/87 OF AN UNK MFR. PT ALSO ALLEGES HAVING CAPSULAR CONTRACTURE OF RIGHT BREAST IN NOV. AND DEC. 1978, LUMPS IN RIGHT BREAST AND RUPTURE OF RIGHT IMPLANT IN 1990; THEREFORE, PT HAD REMOVAL AND REPLACEMENT OF RIGHT IMPLANT ON 2/8/91. REFERENCE MW072615A.
PURSUANT TO INFO REC'D FROM THE PHYSICIAN, THE PT WAS IMPLANTED WITH DEVICE 2/28/96. ON 3/18/96 THE PHYSICIAN NOTED EXTRUSION IN THE PT'S BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
ADD'L INFO IS TO BE SUBMITTED. Y/N? YES. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTEACHED HERETO.
HOSPITAL REPORTS HAPTIC BROKE DURING INSERTION AND WOUND WAS WIDENED TO FACILITATE REMOVAL.
THIS REPORT WAS MAILED IN TO FDA ON: 2/6/97.
THE DEVICE USED A SMALL BOWEL RESECTION WITHOUT INCIDENT. THE PT WAS REOPERATED ON 9/19/96, FOR A COLECTOMY, SMALL BOWEL RESECTION, AND A LIVER BIOPSY. IT IS UNKNOWN WHAT CO'S DEVICE WAS USED DURING THIS CASE AT THIS TIME. THE PT WAS REOPERATED ON 9/24/96, FOR A COLOSTOMY/JEJUNOSTOMY. THERE WAS NECROSIS ALONG THE ANASTOMOSIS. IT IS UNKOWN AT THIS TIME WHICH CO'S PRODUCT WAS USED DURING THIS CASE. THE PT WAS TRANSFERRED TO ICU AND THEN TO THE FLOOR. LATER ON 9/24/96, PT WAS TRANSFERRED BACK TO ICU IN SEPTIC SHOCK. "PT HAD COLECOTMY WITH STAPLE DEVICE USED."
THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION. ADD'L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT WAS REQUESTED FROM THE USER FACILITY. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1978. PT ALSO ALLEGES EXPERIENCING PROBLEMS, INCLUDING VISION BLURRING, HEADACHES AND PAIN FROM 1983 TO 1993 AND NUMBNESS FROM 7/1/94 TO 1995. PHYSICIAN'S NOTE STATES ENCAPSULATION. PT HAD REMOVAL ON 11/7/95.
PHERESIS PLATELET DOWN, BECAME UNRESPONSIVE AFTER 4,599 CC OF BLOOD HAD BEEN PROCESSED. RESPONDED TO AMMONIA STIMULUS, COMPLAINED OF BILATERAL ARM AND LEG PARESTHESIS. 875 CC OF ACD HAD BEEN USED THROUGH AMS INDICATED 455 CC OF ACD INFUSED. STAT CALCIUM LEVEL EQUALED 2.3. CALIUM GLUCONATE ADMINSTERED. MONITORED IN E.R. AND DISCHARGED WITHOUT FURTHER CHANGES.
ORIGINAL MED-WATCH REPORT STATES PT HAD TOTAL KNEE 5/6/95. PT COMPLAINED OF PAIN. COMPONENTS LOOSE. FOLLOW-UP INVESTIGATION WITH THE USER FACILITY (MED-WATCH ORIGINATOR) CONFIRMED THE PT HAD A UNI-COMPARTMENTAL KNEE IMPLANTED ON 5/6/95. PT HAD FUNCTIONED WELL, BUT HAD FLEXED AND FELT A SHARP PAIN IN THE KNEE THEN, PAIN EVER SINCE.
OSTEONICS DISCLAIMER: SUBMISSION OF INFORMATION BY OSTEONICS UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFORMATION IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CASUAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFORMATION IS NOT AN ADMISSION OF THE ACCURACY OF THE INFORMATION CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. THE DEVICE WAS REPORTED AS SURGICALLY REVISED AFTER AN IMPLANTATION PERIOD OF SIXTEEN MONTHS. AS REPORTED ON THE ORIGINAL MED-WATCH REPORT THE DEVICE WAS NOT AVAILABLE FOR EVAL. FOLLOW-UP INVESTIGATION WITH THE USER FACILITY, CONFIRMED IN THE PT'S HISTORY AND PHYSICAL (H&P) FILE THAT THE PT "HAD FUNCTIONED WELL, BUT HAD FLEXED AND FELT A SHARP PAIN IN THE KNEE THEN PAIN EVER SINCE". ACCORDING TO THE USER FACILITY THIS APPARENTLY OCCURRED SEVERAL MONTHS BEFORE THE REVISION SURGERY. FURTHER INVESTIGATIONS, WHICH INCLUDED REVIEWING THE SURGEON'S OPERATIVE REPORT, REVEALED THE TIBIAL COMPONENT WAS REMOVED WITHOUT DIFFICULTY, POLYTHYLENE WEAR WAS OBSERVED POSTERIORLY AND METAL-ON-METAL CONTACT WAS ALSO OBSERVED POSTERIORLY WITH THE FEMORAL COMPONENT. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE CURRENT PACKAGE INSERT STATES, IN PERTINENT PART "LOOSENING OF UNICOMPARTMENTAL KNEE COMPONENTS CAN OCCUR. EARLY MECHANICAL LOOSENING MAY RESULT FROM INADEQUATE INITIAL FIXATION, LATENT INFECTION, PREMATURE LOADING OF THE PROSTHESIS, COMPONENT MALALIGNMENT OR TRAUMA. LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATIONS OR MECHANICAL PROBLEMS, WITH SUBSEQUENT POSSIBILITY OF BONE EROSION AND/OR PAIN." CO'S PACKAGE INSERT CONTINUES BY STATING, "WEAR OF POLYETHYLENE COMPONENTS HAS OCCURRED AND LITERATURE REPORTS HAVE ASSOCIATED ITS OCCURRENCE WITH BONE RESORPTION, LOOSENING AND INFECTION." FINALLY, "ADVERSE EFFECTS MAY NECESSITATE REOPERATION, REVISION, ARTHODESIS OF THE INVOLVED JOINT AND/OR AMPUTATION OF THE LIMB." EVAL CODES: 86 "OTHER"-(OPERATIVE REPORT REVIEWED) 86 "OTHER"-(DEVICE MFG HISTORY RECORDS REVIEWED) 86 "OTHER"-(USER FACILITY REVIEWED PT'S HISTORY AND PHYSICAL REPORT WITH MFG) 100 "OTHER"-(DEVICE MFG HISTORY RECORDS CONFIRMED DEVICE MFG AS PER SPECIFICATIONS) 68 "OTHER"-(PHYSIOLOGICAL LOOSENING). CORRECTED DATA-B5,6; D1,2,3,5,6; F6,7,8,14.
A1,4; B6,7; D10: INFO UNAVAILABLE. SEE THE FOLLOWING CORRESPONDENCE LOG: PT IS 67 YR OLD MALE. 10/22/96, 1430 LEFT MESSAGE AND 800# FOR MD CALL BACK. D5,6; H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR EVAL. F6, 8, 9, 10, 11 AND 13: INFO UNAVAILABLE AT THIS TIME. PT RETURNED TO SURGERY FOR EXPLORATORY LAPAROTOMY DUE TO ABDOMINAL PAIN WITH POSTOPERATIVE INFECTION IDENTIFIED AS WELL AS FAILED CLOSURE. SURGEON ALLEGES STAPLER FAILURE AS REASON FOR SEPSIS." REPORT LISTS TLC75, TRC75, AND 5X60B IN DEVICE LIST.
ON 10/10/96 CO , CLINICAL EDUCATION DEPT., CONTACTED THE ACCOUNT AND OFFERED TO RETRAIN PERSONNEL. THE USER FACILITY INDICATED ON THEIR REPORT IN SECTION F THAT THE REPORT WAS A FOLLOW UP. CO HAS ONLY RECEIVED ONE INITIAL REPORT FROM THE FACILITY AS OF 10/25/96. THE DISPOSABLE KIT WAS NOT AVAILABLE FOR EVALUATION. THEREFORE THE EVALUATION CODE IN SECTION H6 IS 70. THE CS-3000 BLOOD CELL SEPARATOR WAS CHECKED BY CO FIELD SERVICE ON 10/3/96 AND FOUND TO BE IN GOOD WORKING CONDITION. THE D2-D3 PUMP TEST AND THE VOLUME TEST ON ACD WAS CONDUCTED, BOTH TEST WERE PASSED. EVALUATION CODE CONCLUSION: 70 (DEVICE DISCARDED, UNABLE TO FOLLOW UP).
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1977. PT ALSO ALLEGES EXPERIENCING PROBLEMS BEGINNING IN 1985, INCLUDING ACHING INSIDE AND DOWN RIGHT ARM, HARDENING BEHIND RIGHT BREAST, WHICH GRADUALLY WORSENED AND WAS ALSO IN CHEST AND LEFT ARM. PHYSICIAN'S NOTE STATES "POSSIBLE RUPTURE LEFT BREAST IMPLANT, GENERAL SYMPTOMS AND HIGH ANXIETY ABOUT IMPLANTS." PT HAD REMOVAL ON 8/6/96.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES. D1,2,6. NO DEVICE IDENTIFIER, EG. BRAND NAME, CATALOGUE NUMBER, MFG LOT NUMBER ETC. WAS PROVIDED TO CO.
DURING A PTCA PROCEDURE WHILE THE PHYSICIAN WAS PLACING A STENT DEVICE THE GUIDEWIRE PLACEMENT WAS LOST. WHEN THE PHYSICIAN READVANCED THE WIRE ACROSS THE LESION, IT PERFORATED THE CORONARY ARTERY. A PERICARDIAL EFFUSION RESULTED AND THE PT BECAME HEMODYNAMICALY UNSTABLE. THE PT THEN CARDIAC ARRESTED AND WAS NOT RESUSCITATED.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. H6 METHOD: NO INVESTIGATION DUE TO PRODUCT NOT BEING RETURNED. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSP OR DISTRIBUTER.
DURING TOTAL KNEE ARTHROPLASTY, THE FEMUR WAS CUT AND TRIALED WITH PERFECT RESULTS. UPON IMPLANTATION OF THE PROSTHESIS, IT WAS NOTICED THAT THE IMPLANT DID NOT ALIGN AS THE TRIAL. ANOTHER IMPLANT WAS AVAILABLE, AND THE SAME RESULTS WERE EXPERIENCED. THE FEMUR WAS RE-CUT, AND THE SECOND IMPLANT WAS USED FOR SUCCESSFUL IMPLANTATION. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT, ONLY A DELAY ANESTHESIA TIME.
SUMMARY OF EVAL: EVAL RESULTS INDICATE THAT THE COMPONENTS MEET SPECIFICATION GENERALLY AND THAT A SMALL DEVIATION AT THE TOP OF THE PATELLA FLAGE SHOULD NOT CAUSE CONCERN.
THE PT FRACTURED THE ANTEROLATERAL PORTION OF THE FEMUR. THE FEMORAL COMPONENT, TIBIAL COMPONENT, AND PATELLA WERE REMOVED AT THIS TIME AND REVISED TO COMPATIBLE REVISION COMPONENTS.
PT ALLEGES SHE RECEIVED A LEFT BREAST IMPLANT ON 9/12/75. SHE ALSO ALLEGES CAPSULAR CONTRACTURE ON HER LEFT SIDE AS OF SEPT. 1983. PT HAD REMOVAL AND REPLACEMENT ON 4/21/84. PHYSICIAN STATES, "JOINT STIFFNESS AND SORENESS RECENTLY. CONCERN WITH POSSIBILITY OF RUPTURE OF PROSTHESIS (FULLNESS UNDER BOTH AXILLAE)." REFERENCE MW072264, MW072264A.
H3: AVAILABILITY OF DEVICE UNK AT THIS TIME. CONCLUSION: 68A NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN.
PURSUANT TO INFO REC'D FROM THE PHYSICIAN, THE PT WAS IMPLANTED WITH DEVICE ON 6/4/96. SUBSEQUENTLY THE PHYSICIAN NOTED THAT THE PT HAD DEVELOPED AN INFECTION IN HER LEFT BREAST. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
ADD'L INFO IS TO BE SUBMITTED. Y/N ? YES. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. POST EXPLANT THE PHYSICIAN NOTED THE LEAD TO BE FRACTURED WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. FINAL ANALYSIS IS PROVIDED.
WHILE UNDERGOING SURGERY, PT DEVELOPED HIGH CO LEVEL OF 49. THE MACHINE HAD NOT BEEN USED FOR ABOUT 48 HRS. PT WAS NOT INJURED. ANESTHESIA MACHINE WAS TAKEN OUT OF SERVICE. IT IS INTERACTION HIGH CO LEVEL WAS THE RESULT OF AN INTERACTION BETWEEN BARALYME AND DESFLURANE.
THE FILING OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ALLIED HEALTHCARE PRODUCTS, INC. (AHPI) ONE OF ITS DEVICES HAS CAUSED OR CONTRIBUTED TO THE DEATH OR SERIOUS INJURY OR THAT ONE OF ITS DEVICES HAS MALFUNCTIONED. FURTHERMORE, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE REPORT CONCERNS AN AHPI PRODUCT UNLESS AND UNTIL AHPI HAS VERIFIED THAT FACT BY PHYSICAL EXAM OF THE PRODUCT INVOLVED.
DURING LAPAROSCOPIC PROCEDURE, FOR VAGINAL HYSTERECTOMY, EZ35B MISFIRED, WHILE PHYSICIAN WAS USING THE UNIT. PT WAS OPENED AND CARTRIDGE RETRIEVED FROM FIELD AND HYSTERECTOMY WAS COMPLETED. PROCEDURE GIVEN TO CO REPRESENTATIVE FOR EVALUATION." "THIS IS THE SECOND EZ35B THAT MISFIRED WITHIN 3 DAYS.
USER ERROR FAILURE BY RN TO PROGRAM ALL SETTINGS ON PCA PUMP. WHEN BOLUSED, PT REC'D 15 ML VS 15 MG OF DEMEROL IVP. PUMP CASSETTE LOADED WITH DEVISED 10MG/ML . PT REC'D 150 MG WITH BOLUS DOSE. WITHIN MINUTES PT REVERSED WITH NARCAN AND STABILIZED.
THE LEAD WAS EXPLANTED ELECTIVELY. POST EXPLANT THE PHYSICIAN NOTED THE LED TO BE FRACTURED WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
EVEN THOUGH REPORTER STATED THE OVER INFUSION WAS DUE TO USER ERROR IT WAS REQUESTED THAT THE PUMP BE EVALUATED. ADDED D5, 6 AND 7. PORTIONS OF D6. F10. A4. BASELINE REPORT FOR THIS DEVICE FAMILY SUBMITTED WITH 2183502-1996-00010 DATED 9/12/96.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1986. PT ALSO ALLEGES SHE "HAD AN MRI AND POSSIBLE LEAKAGE SHOWED UP."
PRODUCT WAS USED IN THE LCFA FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE WITH NO APPARENT COMPLICATIONS. LATER THAT DAY A FEMORAL BRUIT WAS NOTED. AN ULTRASOUND OF THE LEFT GROIN SHOWED TURBULENCE IN THE DISTAL CFV AND VENOUS FLOW AT THE LEVEL OF THE SFA, SUGGESTING AN AV FISTULA. OCCLUSIVE PRESSURE AND SAND BAG (OVERNIGHT) WERE NOT SUCCESSFUL IN CONTROLLING FISTULA. SURGICAL REPAIR WAS DONE.
CODE 86: EVAL OF EVENT BASED ON MFG AND QC PROCEDURES, AND HISTORICAL USE OF DEVICE AS RELATED TO THIS EVENT. THIS INFO WAS PROVIDED TO A CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. THE PLACEMENT OF COLLAGEN MAY HAVE BEEN A FACTOR IN THIS EVENT. HOWEVER, THIS COMPLICATION IS NOT UNUSUAL FOLLOWING CARDIAC CATHETERIZATION PROCEDURES. THEREFORE, CO CANNOT ATTRIBUTE THIS EVENT TO THE USE OF PRODUCT.
PT HAD PORTACATH IN SINCE 6/17/96, FOR ADMINSTRATION OF IV CHEMO. THE CATHETER WAS IMPLANTED PERCUTANEOUS WITH THE RESERVOIR INSERTED UNDER THE SUBCUTANEOUS TISSUE. ONE WK PRIOR TO 9/27/96, THE PORTACATH COULD NOT BE IRRIGATED. AN X-RAY REVEALED A LEAK OF DYE AROUND THE PORTACATH. ON 9/26/96 A SONOGRAM CONFIRMED BLOCKAGE OF THE PORTA CATH DISTAL TO THE RESERVOIR. THE DR RECOMMENDED REMOVAL. ON 9/27/906 AT 1310, PORTACATH WAS REMOVED. HOWEVER, THE CATHETER WAS NOT PRESENT ON THE PORTACATH RESERVOIR. THE ATTENDING MD CALLED IN THE RADIOLOGIST AT 1400 TO EXTRACT THE CATHETER UNDER FLUOROSCOPY. THE CATHETER WAS SUCCESSFULLY REMOVED. AT 1640 PT DISCHARGED. NO ADVERSE EFFECTS OR OUTCOMES. THESE DEVICES ARE NO LONGER USED. FACILITY NOW USED A NEW BRAND.
THE EZ35W WAS USED DURING A LAVH. THE SURGEIN FIRED THE EZ35W ONCE. IT PARTIALLY FIRED AND JAMMED. THE STAPLES WERE MALFORMED AND HERE WAS STAPLE LINE BLEEDING. THE SURGEON WAS ABLE TO REMOVE THE INSTRUMENT FROM THE TISSUE. THE SURGEON CONVERTED TO OPEN TO THE STAPLE LINE BLEEDING. MEDWATCH RECEIVED 0/17/96 (210040000-1996-0006). STATED "DURING LAPAROSCOPIC PROCEDURE, FOR A VAGINAL HYSTERECTOMY, EZ35B MISFIRED, WHILE PHYSICIAN WAS USING THE UNIT. PT WAS OPENED AND CARTRIDGE RETRIEVED FROM FIELD AND HYSTERECTOMY WAS COMPLETED. PROCEDURE GIEN TO CO REPRESENTATIVE FOR EVALUATION." "THIS IS THE SECOND EZ35B THAT MISFIRED WITHIN 3 DAYS."
A4; B6; D10: INFO NOT PROVIDED BY USER FACILITY. SEE THE FOLLOWING CORRESPONDENCE LOG: 10/9/96 1322 MESSAGE AND 800# ON THE RISK MGMT PM FOR SECREATY, TO FORWARD TO THE APPROPRIATE RISK MGR. 10/9/96 1345 SPOKE TO RM, WHO REFERRED TO BIOMED. 10/9/96 1500 MESSAGE AND 800# LEFT ON PM REQUESTING FOLLOW UP AND ADD'L INFO. 10/10/96 1530 MEDWATCH WILL BE FAXED TOMORROW. D5,6; H4: INFO COULD NOT BE DETERMINED. DAMAGED FIRNNG MECHANISM. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLKUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
PT RECEIVED A RIGHT BREAST IMPLANT ON 6/25/85 AS A REPLACEMENT FOR ONE OF A UNK MFR. PT ALSO ALLEGES HAVING PROBLEMS IMMEDIATELY, INCLUDING HARDENING AND MISPLACEMENT. PT HAD REMOVAL AND REPLACEMENT ON 3/8/95, WITH A DEVICE OF ANOTHER MFR.
THE PT UNDERWENT SURGERY ON 10/3/94 DUE TO OBSERVED NOISE ON THE SENSING LEAD. ALL LEADS WERE DISCONNECTED AND THE ICD WAS TEMPORARILY REMOVED. AT THAT TIME, THE ICD DISPLAYED A BATTERY VOLTAGE OF 6.0 VOLTS. LATER WHEN THE LEADS WERE RECONNECTED, THE ICD SHOWED A BATTERY VOLTAGE BETWEEN 4.0 AND 4.5 VOLTS. THE PHYSICIAN DECIDED TO EXPLANT THE ICD. TWO HRS LATER THE ICD BATTERY VOLTAGE READ 6.3 VOLTS.
H.3 EVAL SUMMARY: CO'S DEVICE TESTING VERIFIED PROPER BRADYCARDIA PACING, ANTITACHYCARDIA PACING, AND SENSING FUNCTIONS. ACCURATE HIGH VOLTAGE CHARGING AND DEFIBRILLATION OUTPUT WAS CONFIRMED, AS WELL AS APPROPRIATE ELECTROGRAM STORAGE. VARIOUS GENERAL PARAMETERS INCLUDING THE BATTERY VOLTAGE AND TELEMETRY RESPONSES OF THE DEVICE WERE ALSO TESTED AND FUNCTIONED WITHIN SPEC. THOROUGH DEVICE ANALYSIS REVEALS NORMAL DEVICE CHARACTERISTICS. ADDITIONAL INVESTIGATIVE STEPS PROVIDE NO SUPPORTIVE EVIDENCE OF A MALFUNCTION. IN CONCLUSION, CO'S ANALYSIS FOUND THAT THE REPORTED EVENT COULD NOT BE DUPLICATED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC RIGHT INGUINAL HERNIOGRAPHY. UPON INSERTION AND RETRACTION OF THE TROCAR THE SURGEON NOTED EXCESS BLOOD ON THE TIP OF THE INSTRUMENT. FURTHER EXAMINATION REVEALED EXCESSIVE BLEEDING. THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY. LACERATIONS TO THE RIGHT ILIAC ARTERY, VEIN AND A PERFORATION OF THE SMALL BOWEL WERE OBSERVED. THE SURGEON TRANSFUSED SIX UNITS OF BLOOD AND PERFORMED A SEGMENTED RESECTION AND GRAFT TO REPAIR THE DAMAGE. THE PT WAS DISCHARGED ON 9/30/96 WITHOUT FURTHER COMPLICATIONS.
COMPLETED SECTIONS: B7, D5, PORTIONS OF D6, D9, D10, F2, F9, F10, F 11. H6: 100 - CATHETER OCCLUSED 68 - DISCONNECTION SUBSEQUENT TO OCCLUSION.  BASELINE REPORT FOR THIS DEVICE FAMILY SUBMITTED WITH 2183502-1996-00001, DATE 7/17/96. A 9" PORTION OF CATHETER WAS RETURNED FOR EVAL, THE PORTAL. COMPONENT WAS NOT RETURNED. VISUAL EXAMINATION BY MICROSCOPY REVEALED NO DEFECTS OF ANOMALIES. IT WAS NOT POSSIBLE TO DETERMINE WHICH END OF THE CATHETER HAD BEEN ATTACHED TO THE PORTAL. ALL DR DIMENSIONS WERE WITHIN SPEC. UPON PRESSURIZATION OF THE CATHETER, VIA SALINE SOLUTION, IT WAS FOUND TO BE OCCLUDED WITH A REDDISH/BROWN SUBSTANCE WHICH WAS VISUALLY CONSISTENT TO THAT OF DRIED BLOOD. APPROX 5.5" FROM 1 END OF THE CATHETER AN ELONGATION WAS NOTED. THIS IS CONSISTENT WITH A CLAVICLE FIRST RIB COMPRESSION. THE CATHETER WAS ATTACHED TO A STANDARD PORTAL WITH NO DIFFICULTY.
10/30/96 -SUBMISSION OF INITIAL REPORT TO FDA.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTUSION. POST EXPLANT THE PHYSICIAN NOTED THE LEAD TO BE FRACTURED WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
THE PT WAS UNDERGOING CORONARY BYPASS SURGERY VIA A MINIMALLY INVASIVE APPROACH. DURING FEMORAL CANNULATION FOR CARDIOPULMONARY BYPASS (CPB), RESISTANCE WAS MET WHILE ADVANCING THE ENDOAORTIC CLAMP GUIDEWIRE. LOW PT BLOOD PRESSURE AND HIGH CPB LINE PRESSURES PROMPTED CONVERSION TO A STANDARD OPEN-CHEST APPROACH. AN AORTIC DISSECTION WAS CONFIRMED, AND WAS REPAIRED. THE PT DIED DUE TO CARDIAC ARREST IN THE INTENSIVE CARE UNIT ON THE DAY OF SURGERY.
CO SENT A NOTIFICATION LETTER TO PHYSICIANS RE-EMPHASIZING THE POTENTIAL RISK OF VASCULAR DAMAGE ASSOCIATED WITH FEMORAL CANNULATION AND THE NEED TO SCREEN PTS FOR PERIPHERAL VASCULAR DISEASE.
THE TIP OF THE CARBIDE PUNCH INSTRUMENT BROKE DURING SURGERY. THE SURGEON ELECTED TO ATTEMPT RETRIEVAL OF THE BROKEN PIECE AND IT REMAINS IN THE PT'S DISTAL FEMUR. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUCNTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO. OR ITS AFFILIATES. D.6 - MFG L/N NOT PROVIDED TO CO. H.4 - DEVICE MFR DATE UNKNOWN BECAUSE THE MFG LOT NUMBER WAS PROVIDED TO CO.
EVALUATION CODES FOR SECTION H6: 100-68 100-THE PRODUCT DOES CONFORM TO TEH AFFECTED SPECIFICATIONS. THE MFG RECORDS AND ORIGINAL LAB RECORDS FOR RAW MATERIAL CONFORM TO STANDARDS. 68-THE FRACTURE SURFACES EXHIBITED FATIQUE STRIATIONS INDICATING THAT THIS DEVICE WAS FRACTURED DUE TO METAL FATIQUE. OTHER DEVICE USED: CATALOG #32-9026-034-35 FEMORAL HEAD LOT #33285800
DEVICE WAS IMPLANTED ON 2/22/96. ON 10/8/96, THE MFR RECEIVED AN EXPLANT RECORD FROM THE FACILITY WHICH STATES THAT THE DEVICE HAD BEEN EXPLANTED PER THE PT'S REQUEST ON 10/8/96 BECAUSE THE PT FELT THAT "IT WAS HEAVY AND GIVES HER GAS".
ON 10/21/96, THE MFR ATTEMPTED TO CONTACT THE EXPLANT PHYSICIAN TO OBTAIN ADD'L DETAILS CONCERNING THIS EVENT; HOWEVER, HE WAS NOT AVAILABLE. THE PHYSICIAN'S OFFICE MANAGER REPORTED THAT AS FAR AS SHE KNEW, THERE HAD NOT BEEN ANY PROBLEMS WITH THE FUNCTION OF THE DEVICE AND THE PT JUST FELT THAT IT WAS UNCOMFORTABLE AND WANTED IT REMOVED. THE MFR INFORMED THE OFFICE MANAGER THAT SINCE THIS EVENT WAS NOT RELATED TO A DEVICE MALFUNCTION OR FAILURE, THEN THE MFR WOULD CLOSE ITS FILE ON THIS REPORT AND SEND THE PHYSICIAN A BRIEF FOLLOW-UP LETTER RESTATING CONVERSATION. NO FURTHER DETAILS AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
PT HAD EXPERIENCED GRADUAL ONSET OF DISCOMFORT IN RIGHT HIP. PT HAS WALKED THREE (3) MILES PER DAY UNTIL THREE MONTHS PRIOR TO REVISION SURGERY. RADIOGRAPHS TAKEN PRIOR TO THE REVISION SURGERY REVEALED EVIDENCE OF POLYETHYLENE WEAR ON THE IDENTIFIED ACETABULAR BEARING INSERT. REVISION SURGERY WAS PERFORMED 12/19/95, AT WHICH TIME THE POLYETHYLENE INSERT AND MATING FEMORAL BEARING HEAD WERE REPLACED.
OSTEONICS DISCLAIMER: SUBMISSION OF INFO BY OSTEONICS UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CASUAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFO ACT. THE ORIGIN OF THIS REPORT WAS FROM CO'S CLINICIAN OFFICE. BASED ON THIS, NO MED-WATCH REPORT WAS RECEIVED FROM A USER FACILITY OR A DISTRIBUTOR. THE IDENTIFIED DEVICE WAS ORIGINALLY IMPLANTED IN CONJUNCTION WITH AN INVESTIGATIONAL DEVICE UNDER IDE STUDY #G870013. THE DEVICE WAS REPORTED AS SURGICALLY REVISED AFTER AN IMPLANTATION PERIOD OF NINETY (90) MONTHS. RADIOGRAPHIC EVALUATION REVEALED EVIDENCE OF POLYETHYLENE WEAR OF THE IDENTIFIED BEARING INSERT. IT IS FURTHER REPORTED THAT AT THE REVISION SURGERY, POLYETHYLENE WEAR WAS CONFIRMED AND THE SUBJECT INSERT WAS REPLACED ON 12/19/95. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE CURRENT PACKAGE INSERT STATES, IN PERTINENT PART "LOOSENING OF TOTAL HIP COMPONENTS CAN OCCUR. LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATIONS OR MECHANICAL PROBLEMS WITH THE SUBSEQUENT POSSIBILITY OF BONE EROSION AND OR PAIN." CO'S CURRENT PACKAGE INSERT STATES. "WEAR OF POLYETHYLENE COMPONENTS HAS OCCURRED AND LITERATURE REPORTS HAVE ASSOCIATED ITS OCCURRENCE WITH BONE RESORPTION, LOOSENING AND INFECTION." FINALLY, "ADVERSE EFFECTS MAY NECESSITATE REOPERATION, REVISION, ARTHODESIS OF THE INVOLVED JOINT, GIRDLESTONE OR AMPUTATION OF THE LIMB/". EVALUATION CODES: METHOD, CODE 86 "OTHER": (DEVICE MFG HISTORY RECORDS REVIEWED) CODE 86 "OTHER": (OPERATIVE REPORT REVIEWED). RESULTS CODE 100, "OTHER": (DEVICE MFG HISTORY RECORDS CONFIRMED DEVICE MFG AS PER SPECIFICATIONS).
FURTHER COMM VIA MFR. RN ON 10/8/96, REVEALED THAT 9/25/96, DR ACCESSED CTR RESERVOIR & EMPTIED DEVICE PERFORMED A BOLUS INJECTION OF 5 FU VIA THE DEVICE PORT (APPROX 27 ML). FIVE MINS AFTER THE PORT BOLUS INJECTION, SEROMA & PUFFINESS WAS NOTED AT SUBCUTANEOUS POCKET SITE. DR THEN ASPIRATED 37 ML OF CLEAR FLUID FROM UNDERNEATH THE SKIN. THE CTR RESERVOIR WAS THEN DRAINED OF THE 50 ML OF FUDR AND REFILLED WITH HEPARINIZED SALINE. ON 10/2/96, DEVICE RESERVOIR WAS EMPTIED (36ML). FLOW RATE WAS WITHIN NORMAL RANGE. DEVICE PORT WAS ACCESSED AND A SLOW PUSH OR NORMAL SALINE WAS GIVEN. AGAIN, FLUID UNDER THE SKIN APPEARED 5 MINS LATER. AT THIS POINT DR SUSPECTED A LEAK AT DEVICE PORT OR CATHETER AND SCHEDULED THE PT FOR A DYE STUDY. THE RESERVOIR WAS FILLED WITH FUDR AND NO PORT BOLUS WAS GIVEN. ON 10/3/96, A DYE STUDY WAS PERFORMED THROUGH THE DEVICE PORT. NO LEAKS OR ABNORMALITIES WERE NOTED. THE DEVICE RESERVOIR WAS EMPTIED AND THE FLOW RATE WAS CALCULATED TO BE WITHIN NORMAL RANGE. THE CTR RESERVOIR WAS FILLED WITH 40 ML OF CONTRAST MEDIA WHICH STAYED IN THE DEVICE 20-30 MINS. NO LEAKS WERE NOTED. THE DEVICE WAS RINSED AND REFILLED WITH HEPARINIZED SALINE. AT THIS TIME THE REASON FOR FLUID UNDER THE SKIN OCCURRING ON 9/25/96, AND 10/2/96 IS UNKNOWN, BUT IT IS SUSPECTED THAT THE NEEDLE WAS IMPROPERLY PLACED DURING PORT BOLUS INJECTION WHICH CAUSED EXTRAVASATION TO OCCUR. FURTHER COMM WITH THE FACILITY RN, ON 10/31/96, REVEALED THAT THE PT'S LAST REFILL WAS UNEVENTFUL. THE RETURN VOLUME WAS NORMAL AND THE DEVICE IS FUNCTIONING AS EXPECTED. THE REVIEW REMAINS IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT.A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS C/N AND HAS NOT IDENTIFIED ANY TRENDS. THE FACILITY'S REPORT OF AND OCCULDED DEVICE CATHETER IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE DEVICE WAS IMPLANTED ON 9/1/96 FOR HEPATIC ARTERIAL INFUSION OF FUDR. ON 10/3/96, A MFR NURSE REC'D A CALL FROM FACILITY NURSE WITH REPORT OF SUSPECTED LEAK FROM CENTER SEPTUM BECAUSE AT THE LAST DEVICE REFILL, THE POCKET SWELLED. A DYE STUDY WAS PERFORMED VIA THE SIDEPORT AND DID NOT REVEAL LEAKS IN SIDEPORT OR CATHETER. THE MD WANTED TO PUT CONTRAST INTO CENTER SEPTUM TO INVESTIGATE ANY POSSIBLE LEAKS THERE; HOWEVER THE MFR NURSE INFORMED FACILITY NURSE THAT IF THEY DID PUT CONTRAST INTO THE CTR DRUG CHAMBER, IT SHOULD BE IMMEDIATELY RINSED OUT WITH SALINE. THE FACILITY NURSE WAS ADDITIONALLY INFORMED THAT THE MFR DOES NOT RECOMMEND THIS PROCEDURE AND REVIEWED SOME OTHER POSSIBLE CAUSES OF THE SWELLING SUCH AS SEROMA, LEAK IN THE CATHETER OR THE CONNECTION. THE FACILITY NURSE STATED THAT THESE POSSIBILITIES HAD BEEN CONSIDERED AND RULED OUT.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE. THE REPORTED PROBLEM COULD NOT BE DUPLICATED, BUT THE THERMAL FUSE WAS REPLACED AS A PRECAUTION. CO TRACE NUMBER OF RETURNED COMPONENT/ASSEMBLY (WHEN APPLICABLE): NA. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT THERE WAS ONE OTHER INCIDENT (CPF 1096165C3) CAUSED BY THE FAILURE INVESTIGATED IN THIS REPORT. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/23/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED 1.5 OHMS, INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHCIH CAUSES THE FUSE TO OPEN. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS, CAUSING THE FUSE TO OPEN. WHEN THE PUMP COOLS DOWN, THE FUSE BECOMES OPERATIONAL AGAIN. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSED THE WAX TO MELT. FOLLOWUP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. FAILURE CODES: F CODE UFPMP004WR. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
RPTR BOUGHT PRODUCT FOR COMFORT AND DURABILITY AS WELL AS FOR EFFECTIVENESS WITH AS MUCH SENSITIVITY AS POSSIBLE. RPTR'S HUSBAND HAS HAD THE PROTECTIVE SKIN SINCE BIRTH AND WHEN HE TRIED THE PRODUCT IT WAS VERY DIFFICULT TO KEEP IN PLACE AT FIRST, BUT WHEN HE MANAGED TO SOMEWHAT, IT WAS VERY UNCOMFORTABLE TO THE POINT WHERE HE COULD NO LONGER WITHSTAND IT.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE. THE REPORTED PROBLEM COULD NOT BE DUPLICATED, BUT THE THERMAL FUSE WAS REPLACED AS A PRECAUTION. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT THERE WAS ONE OTHER INCIDENT (CPF 1096166C3) CAUSED BY THE FAILURE INVESTIGATED IN THIS REPORT. A SECONDARY RESEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/23/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED 1.5 OHMS, INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS, CAUSING THE FUSE TO OPEN. WHEN THE PUMP COOLS DOWN, THE FUSE BECOMES OPERATIONAL AGAIN. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSED THE WAX TO MELT. FOLLOWUP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. FAILURE CODES: F CODE UFPMP004WR. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
A PER FACILITY LETTER DATED 10/25/96, A 79 YR OLD MALE HAD JUST FINISHED HIS BATH & WAS BEING DRESSED. HE WAS SITTING IN THE TUB CHAIR WHICH HAD BEEN TRANSFERRED TO THE CARRIER. THE AIDE DID NOT NOTICE THAT THE LOCKS HAD NOT ENGAGED. AS SHE PULLED THE CARRIER AWAY FROM THE TUB, THE CHAIR ROLLED OFF THE CARRIER. THE CLIENT SUSTAINED 2 1/16" LACERATIONS ON LEFT BUTTOCK AND HAD A SLIGHT REDNESS ON THE BACK OF HIS HEAD.
CO RECEIVED A CALL FROM THE FACILITIES MAINTENANCE MAN. HE SAID THAT A PERSON HAD FALLEN FROM THE CARRIER AND THAT HE FOUND ONE OF THE LOCKS TO BE NOT FUNCTIONING. CO SENT HIM ALL NEW LOCKS NEXT DAY AIR. THE LOCKS ONCE INSTALLED WORKED AND SHOULD PREVENT ANY FURTHER PROBLEMS.
THE NOTCHES ON THE TEST STRIPS OF TWO PACKAGES OF 25 INSIDE THE BOX OF 100 WERE OFF-CENTER. THE NOTCHES WERE SO OFF-CENTER ON ONE BATCH THAT THEY WERE COMPLETELY UNUSABLE. THE NOTCHES ON THE OTHER AFFECTED BATCH WERE SLIGHTLY OFF-CENTER BUT THE PT WAS ABLE TO USE THEM.
THE CORD EMITTED FIRE AND SMOKE. THE UNIT HAS NOT BEEN RETURNED TO CO FOR INSPECTION AND MAY NOT BE. NO DEATHS OR INJURIES WERE REPORTED. THE UNIT WAS REPORTED TO BE AN OLD-STYLE CORD AND SWITCH. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING? Y. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS SEVERITY OF THIE EVENT GREATER THAN LABELED? N.
A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. CO NUMBER OF RETURNED COMPONENT/ASSEMBLY (WHEN APPLICABLE) NA. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT THERE WAS ONE OTHER INCIDENT (CPF 1096157C3) CAUSED BY THE FAILURE INVESTIGATED IN THIS REPORT. THIS SECOND COMPLAINT WAS FOR A SECOND PT WHICH WAS AFFECTED BY THE SAME FUSE FAILURE. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/21/96.THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED 00.1 OHMS, INDICATING THAT THE FUSE WAS STILL POTENTIALLY GOOD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSED THE FUSE TO OPEN. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS. WHEN THE PUMP COOLS DOWN, THE FUSE BECOMES OPERATIONAL AGAIN. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE, IT IS NOT KNOWN AT THIS TIME WHAT CAUSED THE WAX TO MELT. FOLLOWUP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. FAILURE CODES: F CODE UFPMP004WR. CUSTOMER CONTACTED: YES. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS THEY HAVE NOT BEEN RETURNED TO CO BUT RATHER HAVE BEEN DISCARDED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE TIBIAL COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. THE LOT CODE FOR THE PATELLAR COMPONENT HAS NOT BEEN SUPPLIED SO THAT A REVIEW OF ITS DEVICE HISTORY RECORD IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THIS LOT CODE INFORMATION HAVE BEEN UNSUCCESSFUL.
IMPLANTS DID NOT INTEGRATE. EXACT DATE OF OCCURRENCE IS UNKNOWN.
INFO RECEIVED FROM THE DOCTOR INDICATES THAT THE IMPLANTS WERE REMOVED BECAUSE OF THEIR LOCATION, NOT BECAUSE OF A FAILURE TO INTEGRATE.
PT HAD INTRAAORTIC BALLOON PUMP IN PLACE. HAD GONE TO NUCLEAR MEDICINE FOR CARDIAC SCAN. LOW BATTERY ALARM CAME ON WHILE PT WAS IN TRANSIT BETWEEN UNITS. (PUMP HAD BEEN PLUGGED TO HOUSE POWER WHILE IN NUCLEAR MEDICINE SUITE) WITHIN 2 MINS OF ALARM, BATTERY FAILED. NO ADVERSE EVENT SINCE PT WAS NEAR INTENSIVE CARE UNIT AND PUMP WAS QUICKLY PLUGGED INTO HOUSE POWER.
ARTERIAL SHEATH #6 FRENCH BROKE OFF AS PHYSICIAN WAS REMOVING SHEATH FROM RIGHT FEMORAL ARTERY DURING CARDIAC CATHETERIZATION.
A BLADDER NECK SUSPENSION PROCEDURE WAS PERFORMED ON A DIABETIC PT. SOME TIME POST PROCEDURE, THE PT REPORTEDLY DEVELOPED A BONE INFECTION. THE PT UNDERWENT SURGICAL REMOVAL OF THE BONE ANCHORS AND A SMALL PIECE OF HER PELVIC BONE. TO DATE NO FURTHER DETAILS ARE AVAILABLE. "RISK FACTORS SUCH AS OBESITY, DIABETES, AND IMMUNOCOMPROMISED PTS CAN FURTHER PREDISPOSE THE PUBIS TO INFECTION." "OSTEOMYELITIS OF THE PUBIS: COMPLICATION OF A STAMEY URETHROPEXY." THE JOURNAL OF UROLOGY, VOL 151 (JUNE 1994). PP1638-1640.
INFO SUPPLIED IN SECTION F WAS COMPLLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTON WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
IMPLANT DID NOT INTEGRATE. IT WAS PLACED 4/9/96 AND REMOVED 8/29/96.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS, WITH SOME TISSUES IN THE APICAL HOLES. A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. IT IS POSSIBLE THAT THE PT'S ALLERGIES AND CARDIAC PROBLEMS INHIBITED THE BODY'S HEALING CAPABILITIES. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS THEY HAVE NOT BEEN RETURNED TO CO BUT RATHER HAVE BEEN DISCARDED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE TIBIAL COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. THE LOT CODE FOR THE PATELLAR COMPONENT HAS NOT BEEN SUPPLIED SO THAT A REVIEW OF ITS DEVICE HISTORY RECORD IS POSSIBLE. ATTEMPTS TO OBTAIN THIS LOT CODE INFORMATION HAVE BEEN UNSUCCESSFUL.
USER FACILITY PERSONNEL DID NOT FOLLOW THE OPERATOR MANUAL INSTRUCTIONS AND; THEREFORE, INCORRECTLY INSTALLED A CO-OBSERVATION TUBE. THE CO-OBSERVATION TUBE WAS INSTALLED ON THE PT SIDE OF THE EYE SAFETY FILTER WHICH PERMITTED UNFILTERED LASER LIGHT THROUGH THE CO-OBSERVATION TUBE INTO PERSONNEL'S EYES. THIS RESULTED IN TWO USER FACILITY PERSONNEL WHO WERE OBSERVING THE PROCEDURE THROUGH THE CO OBSERVATION TUBE, RECEIVING PERMANENT, ALTHOUGH MINOR, DAMAGE TO THEIR VISION. NO MEDICAL INTERVENTION WAS TAKEN. THE PERSONNEL ARE STILL UNDER OBSERVATION.
H3 USER FACILITY DISCOVERED INCORRECTLY INSTALLED CO-OBSERVATION TUBE AFTER PERSONNEL COMPLAINED OF "BRIGHTNESS" OF THE LIGHT THRU THE TUBE. USER FACILITY CORRECTLY INSTALLED THE CO-OBSERVATION TUBE AND NOTIFIED COHERENT OF INCIDENT. DEVICE WAS NOT EVALUATED BY COHERENT. IS THE FREQUENCY OF OCCURRENCE OF EVENT ADDRESSED IN DEVICE LABELING? NO. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? UNK. IS THE SEVERITY OF OCCURRENCE OF EVENT ADDRESSED IN DEVICE LABELING? NO. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? UNK. PREPARATION OR SUBMISSION TO FDA OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MEDICAL DEVICE CAUSED OR CONTRIBUTED TO DEATH OR SERIOUS INJURY.
WHEN IMPLANTING LENS, AFTER CATARACT REMOVAL, THE LENS LOOP PULLED OFF THE LENS. PT REFERRED TO RETINAL SPECIALIST TO RETRIEVE LENS AND REIMPLANT AN IOL.
IMPLANT DID NOT INTEGRATE AND WAS REMOVED 10/7/96.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. THE PT'S SMOKING AND ALCOHOL USE ARE PROBABLE CAUSES OF FAILURE.
IMPLANT NEVER INTEGRATED, IT WAS PLACED 4/3/96 AND REMOVED 10/2/96.
THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. THE PROBABLE CAUSE OF FAILURE IS THE REPORTED INFECTION, COMPOUNDED BY THE PT'S SMOKING.
IMPLANT PLACED 11/30/95. WHEN IMPLANT WAS UNCOVERED ON 9/24/96, DR DISCOVERED MOBILITY. WHEN DR TESTED IT, THE IMPLANT CAME OUT.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. THE PT'S SMOKING IS THE PROBABLE CAUSE OF FAILURE.
IT WAS REPORTED THE SURGEON WAS SUTURING AND THE NEEDLE SNAPPED. HALF OF THE NEEDLE WAS LEFT STICKING IN TISSUE.
LOT HISTORY CHECK INDICATES THERE WAS NO PROBLEM WITH THE MFR OF THIS LOT. TEST RESULTS OF RETURNED AND RETENTION SAMPLES ARE SATISFACTORY AND AGREE WITH LOT RELEASE TEST RESULTS. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECCESSARILY REFLECT A CONCLUSION OR ADMISSION BY THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
FACILITY ALLEGES A POSSIBLE ADVERSE REACTION OCCURRED WITH THE CO DIALYZER WITHIN THE FIRST TEN MINUTES OF TREATMENT. PT COMPLAINED OF SEVERE LOWER BACK PAIN, AND WAS GIVEN BENADRYL INTRA-MUSCULAR, AND TYLENOL BY MOUTH FOR SYMPTOMS. BLOOD WAS RETURNED AND TREATMENT DISCONTINUED. NO BLOOD LOSS OR PT INJURY REPORTED.
F10-PT CODE 2200-BACK PAIN. F3-MFR/DISTR IS THE SAME. F13-THIS IS BEING REPORTED AS A MFR NOT AS A DISTRIBUTOR.
IS THE EVENT LISTED IN INSERT? NO. IS THE EVENT OCCURRING MORE FREQUENTLY? NO. IS THE EVENT'S SEVERITY LISTED IN INSERT? NO. IS THE EVENT'S SEVERITY LISTED IN INSERT? NO. IS THE SEVERITY OCCURRING MORE FREQUENTLY? NO. DISCLAIMER: INJURY A MEDICAL DOCTOR FROM THE UNITED KINGDOM REPORTED THAT A MAN HAD A NOVOFINE. NEEDLE BREAK AND REMAIN IN HIS ABDOMINAL WALL IN THE PRESENCE OF A DIABETES NURSE SPECIALIST. THE EVENT REQUIRED ADMISSION FOR SURGICAL REMOVAL WHICH WAS SUCCESSFUL. NO FURTHER INFO IS AVAILABLE.
INJURY: FOLLOW-UP INFO RECEIVED INDICATES THAT THE NEEDLE IN QUESTION WAS A NOVOFINE 28 DISPOSABLE. NEEDLE, NOT A NOVOFINE 30. IT WAS REPORTED THAT THE NEEDLE HAD BEEN USED MORE THAN ONCE, BUT WAS NOT BENT BEFORE USE.
IMPLANT WAS EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. COMPLETE LATERAL AND APICAL BONE LOSS WAS NOTED.
86=DIMENSIONAL ANAYLSIS 100 = VISUAL EXAMINATION SHOWED BONE TISSUE MATTER PRESENT ON THE COATING AND THE BASKET OF THE IMPLANT. THE RETURNED COMPONENT MET THE REMAINING CO DIMENSIONAL SPECIFICATIONS.
PT EXPERIENCED CARDIAC ARREST. APPROX 2 1/2 HOURS AFTER CT OF CHEST.
DURING DIALYSIS, PT PULLED OUT VENOUS NEEDLE. VENOUS LOW ALARM DID NOT SOUND NOR DID REVERSE TRANSVERSE MEMBRANE PRESSURE ALARM. NURSE SAW APPROX 300CC BLOOD ON FLOOR AND DISCONTINUED DIALYSIS. MACHINE TAKEN OUT OF SERVICE AND CHECKED BY BIOMED AND MFR. MALFUNCTION COULD NOT BE DUPLICATED. MACHINE RECALIBRATED AND RETURNED TO SERVICE. PT DID NOT EXPERIENCE ANY LONG TERM EFFECTS.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION.
H.3 = DEVICE EVALUATED BY THE DISTRIBUTOR. THE RESULTS OF THE EVALUATION WILL BE FORWARDED TO THE MFR. 86 = DIMENSIONAL ANALYSIS. 100 = VISUAL EXAMINATION SHOWED TISSUE ON THE THREADS OF THE IMPLANT. TOOL MARKS WERE NOTED ON THE HEALING SCREW, WHICH MAY BE ATTRIBUTED TO THE REMOVAL PROCEDURE. THE RETURNED COMPONENT MET CO DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
LOCATED IN THE #12 AREA FOR A THREE UNIT BRIDGE ATTACHED TO A NATURAL CROWN WITH A STRESS BREAKER. THE PT STATED THAT THE BRIDGE SNAPPED. NOT SURE IF THIS HAPPENED WHILE EATING OR NOT. THE PT CAME IN THE OFFICE WITH THE BRIDGE IN HAND.
THE FEMALE LUER SEPARATED FROM THE TUBING AND LEAKED.
THE SUB ASSEMBLY PART IN QUESTION IS A TUBING SET THIS COMPONENT IS INCORPORATED INTO THE FINISHED PRODUCT OF CO'S DEVICE WHICH WAS INVOLVED IN THIS EVENT. THE COMPONENT IS ASSEMBLED BY CO AND SUPPLIED TO, A SUBSIDIARY OF CO. THE FINISHED PRODUCT IS PACKAGED AND STERILIZED BY CO. THE CUSTOMER RETURNED ONE SAMPLE TO CO FOR EVAL. EXAM OF THE RETURNED UNIT SHOWED THAT THE FEMALE LUER WAS BROKEN OFF THE TUBING. THE BREAKAGE IS POSSIBLY DUE TO BRITTLE TUBING OR STORAGE CONDITIONS. THE LOT HISTORIES WERE REVIEWED AND WERE FOUND TO BE ACCEPTABLE. CO WAS ABLE TO CONFIRM THIS ISSUE AND TO DETERMINE A POSSIBLE CAUSE. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
THE IMPLANT WAS EASILY REMOVED FROM THE SITE. PT IS REPORTEDLY FINE.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE DR REPORTED THAT THE REASON FOR REMOVAL OF THE IMPLANT WAS THAT THE IMPLANT "MIGRATED SUPERIORLY."
86 = DIMENSIONAL ANALYSIS 100 = THE RETURNED COMPONENT MET CO VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
THE REPORTED MACHINE IS NOT CURRENTLY UNDER A SERVICE AGREEMENT WITH CO. THEREFORE, ALL OF THE MACHINE'S CALIBRATION AND MAINTENANCE IS THE FACILITY'S RESPONSIBILITY. THE FACILITY STATED THAT THE MACHINE'S A/V PRESSURES AND ALARM WINDOWS WERE CALIBRATED INCORRECTLY DUE TO A NEW BIOMED TECH. THE FACILITY STATED THAT AFTER THE REPORTED INCIDENT THEIR NEW TECHNICIAN AND ONE OF THEIR MORE EXPREIENCED TECHNICIANS RE-CALIBRATED THE MACHINE PROPERLY. A MES REPRESENTATIVE WAS ASKED "TO LOOK AT THE MACHINE" WHILE ON ANOTHER SERVICE CALL IN THE UNIT, BUT WAS GIVEN NO SPECIFICS. HE SAW THE MACHINE WAS APPARENTLY RUNNING OK, AND DID NOT WORK ON IT. FOLLOW-UP ACTION: THE MACHINE FAILURE DESCRIBED IN THIS C0MPLAINT WAS GENERATED DUE TO A MISCALIBRATED MACHINE DONE BY THE FACILITY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATION, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED: YES. SALES/SERVICE CONTACTED BY INVESTIGATOR? YES. TRAINING REQUIRED? NO.
THE NURSE OBSERVED BLOOD IN THE PUMP AND THE PUMP WAS ALARMING. THE SITUATION WAS IGNORED BY THE ICU NURSES. THIS RESULTED IN DAMAGE TO THE PUMP. THE PT EXPERIENCED NO COMPLICATIONS. THE IAB HAD BEEN IN USE FOR TWENTY HRS BEFORE THE FIRST PUMP ALARM. IT IS SUSPECTED THAT THE BALLOON LEAKED.
MALE PT HAD A BILATERAL HERNIA REPAIR. THE SURGERY PROCEEDED NORMALLY WITH NO COMPLICATIONS DURING SURGERY. PT WAS DISCHARGED FROM THE HOSP. A FOLLOW UP TELEPHONE CALL TO THE PT REVEALED THE PT HAD NOT VOIDED SINCE LEAVING THE HOSP. ACCORDING TO THE PT, HE DID VOID AT THE HOSP PRIOR TO LEAVING. THE PT RETURNED TO THE HOSP AND WAS CATHETERIZED. APPROX 700CC OF URINE WAS COLLECTED AND BLOOD WAS PRESENT IN THE URINE. THE PT REMAINED CATHETERIZED AND RETURNED TO A UROLOGIST APPROXIMATELY 5 DAYS LATER TO HAVE THE CATHETER REMOVED. A CYSTOGRAM INDICATED A HOLE IN THE BLADDER IN THE MIDLINE REGION AND BELOW THE SYMPHYSIS PUBIS. THE HERNIA REPAIRS WERE HEALING AS ANTICIPATED AND THE PT REPORTED NO PAIN. SURGERY WAS PERFORMED TWO WEEKS AFTER THE INITIAL HERNIA SURGERY TO REPAIR THE HOLE IN THE BLADDER AND THE PT HAS REPORTED NO ADD'L COMPLICATIONS.
THE SURGEON REPORTED THAT THE BILATERAL HERNIA REPAIR PROCEEDED NORMALLY. THIS PARTICULAR SURGERY SITE HAS PERFORMED APPROX 120 CASES USING THE SURGICAL BALLOON DISSECTOR. THE SURGEON NOTED THAT NO SUCTION WAS USED DURING SURGERY, NO BLEEDING WAS OBSERVED, AND NO URINE WAS DETECTED DURING SURGERY. THE SURGEON SURMISED THAT URINE WOULD HAVE BEEN PRESENT IF THE BLADDER WAS PERFORATED DURING SURGERY. THE SURGEON ALSO NOTES THAT THE AREA OF THE BLADDER PERFORATION IS NOT IN THE AREA WHERE BALLOON DISSECTION OCCURS; DISSECTION FOR A HERNIA REPAIR OCCURS ABOVE AND LATERAL TO THE MIDLINE. THE SURGEON IS UNABLE TO POSITIVELY STATE THAT THE BALLOON DISSECTOR CAUSED OR CONTRIBUTED TO THIS EVENT. THIS PARTICULAR DEVICE WAS SOLD BY A DISTRIBUTOR OF THE MFR. THE DISTRIBUTOR BECAME AWARE OF THIS EVENT ON 9/17/96. BY AGREEMENT BETWEEN THE MFR AND DISTRIBUTOR, THE DISTRIBUTOR ACTS UPON ANY REPORTABLE EVENT FOR PRODUCT SOLD BY THE DISTRIBUTOR. HISTORICALLY, THE DISTRIBUTOR HAS PERFORMED THIS REQUIREMENT. THE MFR BECAME AWARE ON 10/25/96 THAT THE DISTRIBUTOR DID NOT FILE THIS EVENT.
THE RPTR RETURNED PRODUCT FOR A DIFFERENT ISSUE. IT WAS DISCOVERED DURING THE RETURNED PRODUCT EVAL THAT THE BLUE BALL FAILED TO SEAT WHEN THE BURETTE WAS EMPTY.
THE CUSTOMER RETURNED ONE SAMPLE TO CO FOR EVAL. EXAM OF THE RETURNED UNIT SHOWED THAT BLUE BALL WAS UNABLE TO SEAT PROPERLY DUE TO THE TULIP BEING WARPED. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED VACUUM TESTING DURING ASSEMBLY TO DETECT THIS TISSUE. RETAINED PRODUCT SAMPLES WERE EVALUATED AND WERE FOUND TO BE ACCEPTABLE. THE LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. CO WAS ABLE TO CONFIRM THIS ISSUE AND TO DETERMINE THE CAUSE. BASED ON THIS INFO, CO BELIEVES THAT THIS ISSUE HAS BEEN ADDRESSED AND THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME.
DURING REMOVAL OF THE CATHETER, A PIECE SEPARATED AND REMAINED IN THE PT. THE CATHETER WAS PLACED ON 10/17/96 IN A 72 YR OLD FEMALE UNDERGOING SURGERY. REMOVAL WAS ATTEMPTED ON 10/20/96. A NEUROSURGEON REMOVED THE SEPARATED PORTION WITH A MINOR SURGICAL PROCEDURE. THERE WERE NO PT COMPLICATIONS. THE HOSPITAL IS UNWILLING TO RETURN THE CATHETER TO CO.
DURING AN ATTEMPT TO DEPLOY AN ENDOVASCULAR STENT AT THE TARGET LESION SITE IN THE PT'S RIGHT COMMON ILIAC ARTERY, THE STENT DISLOGED FROM THE BALLOON CATHETER IN THE LEFT COMMON ILIAC ARTERY. AN EXPLORATORY LAPAROTOMY WAS PERFORMED TO RETRIEVE THE STENT AND REPAIR THE POPLITEAL ARTERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THIS STENT IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 9/29/89 AND REVISED ON 9/24/96 DUE TO A "TUBING FRACTURE." REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT  AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES.
PER THE INFO PROVIDED TO CO BY HOSPITAL, THE DEVICE WAS REMOVED DUE TO A "TUBING FRACTURE". AS REPORTED TO US, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A 3-PIECE INFLATABLE PENILE PROSTHESIS.
THE CATHETER WAS INSERTED, AFTER SOME DIFFICULTY, IN A 51 YR OLD OBESE FEMALE PT. DURING THE SUTURING OF THE CATHETER, THE PT'S HEART RATE SUDDENLY DROPPED FROM 80 TO 50. THE CATHETER WAS REMOVED AND THE PT WAS SUCCESSFULLY RESUSCITATED. THE PT WAS TRANSFERRED TO ICU, WHERE SHE DIED SUDDENLY. AN AUTOPSY REVEALED A NICK IN THE AORTA AND THE CAUSE OF DEATH WAS LISTED AS INTERNAL BLEEDING LEADING TO TAMPONADE. THE PHSICIAN STATED THAT THE PRODUCT WAS NOT DEFECTIVE AND THE INCIDENT WAS PROCEDURE RELATED.
THE MALE LUER ON THE SYRINGE CRACKED AND LEAKED.
THE SUB ASSEMBLY PART IN QUESTION IS A CONTROL SYRINGE. THIS COMPONENT IS INCORPORATED INTO THE FINISHED PRODUCT OF DEVICE WHICH WAS INVOLVED IN THIS EVENT. THE COMPONENT IS ASSEMBLED BY CO AND SUPPLIED TO CO. A SUBSIDIARY OF CO. THE FINISHED PRODUCT IS MFG, PACKAGED AND STERILIZED BY CO. INVESTIGATION FROM A PREVIOUS SIMILAR COMPLAINT INDICATES THAT HIS ISSUE IS RELATED TO A MOLDING AND CORE PINS HAVE BEEN REPAIRED. THIS PARTICULAR LOT WAS MOLED PRIOR TO THESE CHANGES.
PLAINTIFF REPORTS INITIAL IMPLANTATION OF THE RIGHT IMPLANT 9/29/83. PLAINTIFF ALLEGES" A DISABLING DISEASE AND RUPTURE".
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: REC'D PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MFNUFACTURED, OR SOLD BREAST IMPLANTS. COS INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF A CORP IN 1986. F10: LABELING REC'D PER LITIGATION.
THE PUMP WAS BEING USED TO DELIVER A FIBER-CONTAINING ENTERAL FEEDING SOLUTION IN A PREFILLED CONTAINER AT 100 ML/HR. THE 8 FRENCH FEEDING TUBE BEING USED (PLACED AS A JEJUNOSTOMY ON 9/9) BECAME MINIMALLY OCCLUDED ON 9/25, AND PUMP DELIVERED LESS THAN ORDERED WITH NO OCCLUSION ALARM. THE PT'S BLOOD SUGAR DROPPED TO 50 MG/DL ON 9/25/96 SINCE INSULIN WAS BEING DELIVERED BY IV PUMP. AT LEAST THREE ENTERAL PUMPS WERE TRIED, BUT THE FEEDING SOLUTION COULD ONLY BE DELIVERED AT 100 ML/HR EVEN IF THE PUMP WAS SET AT 200 ML/HR. THE FEEDING TUBE HAD BEEN FLUSHED WITH WATER EVERY 4 HOURS THROUGHOUT FEEDING. WHEN FLUSHED EVERY 8 HOURS WITH COLA, THE PUMP FED AS DESIRED. THE PUMPS WERE PLUGGED IN FOR AT LEAST 23 HOURS/DAY. NO OCCLUSION ALARMS WERE HEARD ON THESE PUMPS.
2343 -LABELED (LABELED IN CORRESPONDING ADMINISTRATION SET LABELING). CO'S STANDARD PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE REPORTER FOR COMLETION AND RETURN. IN THIS CASE, THE REPORTER DID NOT PROVIDE THE REQUIRED INFO FOR SECTION F2 AND F10.
ADD'L INFO WAS OBTAINED THROUGH MEANS OF PHYSICIAN/SURGEONS OPERATIVE REPORT (SEE SECTIONS B-5, B-6, B7, G-7). IN RECEIVED INFO, PHYSICIAN STATED THAT THIS SURGERY OCCURRED BECAUSE PT HAD AN "INFECTED PENILE PROSTHESIS PUMP." MFR RECEIVED PUMP, TWO CYLINDERS, RESERVOIR, A PORTION OF RESERVOIR TUBING, AND TWO REAR TIP EXTENDERS. BECAUSE QUALITY ASSURANCE'S EXAMINATION OF RETURNED COMPONENTS CAN NOT CONCLUSIVELY CONFIRM NOR DISPROVE REPORT OF INFECTION, QA ACCEPTS PHYSICIAN'S OBSERVATION OF INFECTION AS REASON FOR SURGICAL INTERVENTION. REVIEW OF DEVICE LOT HISTORY RECORDS BY QA INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON KNOWLEDGE, QA CONCLUDES THAT DEVICE WAS STERILE PRIOR TO DEVICE PACKAGING BEING OPENED AND THAT INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN DEVICE.
THE SWITCH EMITTED SMOKE. NO DEATHS OR INJURIES WERE REPORTED. THE UNIT HAS NOT BEEN RETURNED FOR INSPECTION AND MAY NOT BE. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CFR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVIVE LABELING?Y. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IN SEVERITY OF OCCURRENCE OF THE ADDRESSED IN DEVICE LABELING? Y. A SEVERITY OF THIS EVENT GREATER THAN LABELED?N.
IT WAS REPORTED THAT THE PUMP APPEARED TO BE OPERATING BUT NOT DELIVERING ANY FLUID. DURING I&O CALCULATIONS AFTER 8 HRS IT WAS NOTED THAT 300ML OF HEPARIN SHOULD HAVE BEEN DELIVERED HOWEVER THE 500 ML CONTAINER WAS STILL FULL. THE PUMP WAS REMOVED FROM PT USE. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.
SECTION F COMPLETED BY MFR. THE INFUSION PUMP WAS NOT RETURNED TO CO FOR EVALUATION. THE BIOMED. DEPT. AT THE HOSPITAL EVALUATED THE PUMP AND FOUND NO ABNORMALITIES IN ITS OPERATION. THE PUMP HAS BEEN RETURNED TO USE. THE MOST LIKELY CAUSE OF THE OCCURRENCE WAS IMPROPER LOADING OF THE IV TUBING IN THE INFUSION PUMP.
THE BLUE BALL FAILED TO SEAT WHEN THE BURETTE WAS EMPTY ALLOWING AIR TO ENTER THE TUBE.
CUSTOMER INDICATED SAMPLES WOULD BE RETURNED TO CO FOR EVALUATION. SAMPLES WERE NOT RECEIVED. THIS MDR IS BEING CLOSED WITHOUT BENEFIT OF RETURNED PRODUCT. BASED ON INFO FROM PREVIOUS SIMILAR COMPLAINTS, MEDEX BELIEVES THAT THIS IS RELATED TO THE BLUE BALL NOT SEATING DUE TO THE SEAT BEING DERFORMED. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED VACUUM TESTING DURING ASSEMBLY TO DETECT THIS ISSUE. THIS LOT WAS MANUFACTURED PRIOR TO THIS CHANGE. CO IS UNABLE TO CONFIRM THIS ISSUE BUT IS ABLE TO DETERMINE THE PROBABLE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVALUATION. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
PLAINTIFF REPORTS INITIAL IMPLANTATION OF THE LEFT IMPLANT 9/29/83 WITH EXPLANT 4/29/91. PLAINTIFF ALLEGES DISABLING DISEASE AND RUPTURE.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: REC'D PER LITIGATION. MULTILE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MANUFACTURED, OR SOLD BREAST IMPLANTS. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF A CORP IN 1986. F10. LABELING REC'D PER LITIGATION.
THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT WAS DISCARDED. THE REPORTER OBTAINED A COMPANION SAMPLE, TUGGED ON THE PILOT LINE WHICH LED TO SEPARATION. THE EVALUATION RESULTS FOR THAT SEPARATION ARE AS FOLLOWS: VISUAL EXAMINATION OF THE PRODUCT UPON RECEIPT REVEALED THE ENTIRE PILOT ASSEMBLY LINE WAS DETACHED FROM THE MAIN TUBE. EVIDENCE OF GLUE WAS FOUND AT THE TIP OF THE PILOT ASSEMBLY LINE APPROX. 8MM AWAY FROM THE INFLATION TUBE APERTURE AND IN THE NOTCH OF THE MAIN TUBE WHERE THE PILOT INFLATION LINE WAS ATTACHED. THESE OBSERVATIONS INDICATE THE PRODUCT DID UNDERGO THE PILOT ASSEMBLY PROCESS. IT IS POSSIBLE THAT SUCH DETACHMENT COULD HAVE BEEN DUE TO UNLIMITED FORCE EXERTED ON THE TUBE DURING REMOVAL FROM THE PACKAGE/USAGE.
THE PUMP WAS BEING USED TO DELIVER A FIBER-CONTAINING ENTERAL FEEDING SOLUTION IN A PREFILLED CONTAINER AT 100 ML/HR.THE 8 FRENCH FEEDING TUBE BEING USED (PLACED SURGICALLY AS A JEJUNOSTOMY ON 9/9) BECAME MINIMALLY OCCLUDED ON 9/25, AND THE PUMP DELIVERED LESS THAN ORDERED WITH NO OCCLUSION ALARM. THE PT'S BLOOD SUGAR DROPPED TO 50 MG/DL ON 9/25/96 SINCE INSULIN WAS BEING DELIVERED BY IV PUMP. AT LEAST THREE ENTERAL PUMPS WERE TRIED, BUT THE FEEDING SOLUTION COULD ONLY BE DELIVERED AT 100 ML/HR EVEN IF THE PUMP WAS SET AT 200 ML/HR. THE FEEDING TUBE HAD BEEN FLUSHED WITH WATER EVERY 4 HRS THROUGHOUT FEEDING. WHEN FLUSHED EVERY 8 HOURS WITH COLA, THE PUMP FED AS DESIRED. THE PUMPS WERE PLUGGED IN FOR AT LEAST 23 HOURS/DAY. NO OCCLUSION ALARMS WERE HEARD ON THESE PUMPS.
2343 -LABELED (LABELED IN CORRESPONDING ADMINISTRATION SET LABELING). CO STANDARD PROCEDURE INCLUDES SENDING THE REPORTER A MEDWATCH FORM FOR COMPLETION AND RETURN. IN THIS CASE, THE REPORTER DID NOT PROVIDE THE REQUIRED INFO FOR SECTON F2 AND F10.
THE DEVICE EXPERIENCED A "RESERVOIR CAPSULE CONTRACTURE". THE "CAPSULE WAS BROKEN, AND THE CONNECTORS ONLY WERE REMOVED AND REPLACED". THE PHYSICIAN'S OFFICE STATED THAT THERE IS NO DEVICE, NOR DEVICE COMPONENT(S) TO BE RETURNED TO THE MFR.
AS REPORTED TO CO'S OFFICE BY THE PHYSICIAN'S OFFICE, THE CONNECTOR(S) ONLY WERE REMOVED: THE HOSP DISPOSED OF THEM AT THE TIME OF SURGERY. ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 8/10/93 AND REVISED ON 7/30/96 DUE TO "RESERVOIR CAPSULE CONTRACTURE." IN THE RECEIVED INFO THE PHYSICIAN STATED THAT THE PT "HAD DEVELOPED EXCESSIVE PERIPROSTHETIC CAPSULE FORMATION AROUND THE RESERVOIR. HE IS ADMITTED FOR REVISION OF HIS PROSTHESIS WITH CORRECTION OF HIS HYDRAULIC ABNORMALITY." THE PHYSICIAN FURTHER STATED THAT DURING SURGERY THE "RESERVOIR WAS DISTENDED TO 150 CC WITH PALAPABLE AND AUDIBLE RUPTURING AT THE CAPSULE." THE CONNECTORS ONLY WERE REMOVED AND REPLACED. QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED CONNECTORS FOR EVAL. HOWEVER, BECAUSE QA'S EXAM OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF "CAPSULE FORMATION," QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF "EXCESSIVE PERIPROSTHETIC CAPSULE FORMATION" AS THE REASON FOR SURGICAL INTERVENTION. BECAUSE THE PROSTHESIS REMAINS IMPLANTED  AND IS FUNCTIONING AS INTENDED. QA CONCLUDES THAT NO FUNCTIONAL ABNORMALITIES CONTRIBUTED TO THIS OCCURRENCE AND THAT THE NOTED "HYDRAULIC ABNORMALITY," BASED ON THE PROVIDED INFO, WAS MOST LIKELY REPERCUSSIVE OF THE CAPSULE FORMATION AROUND THE RESERVOIR.
INITIAL CONTACT WAS RECEIVED VIA A LENS ACCOUNTABILITY FORM IN WHICH A LENS WAS DENCENTERED AND REPLACED. ON 10/15/96 THE PHYSICIAN INDICATED THAT A PT HAD AN INITIAL LENS IMPLANT INTO THE LEFT EYE WITH A ONE PIECE PMMA 10L, MODEL 811A + 18.0 (D) FOLLOWING A TRAUMATIC CATARACT EXTRACTION. ONE DAY POST OPERATIVE, THE LENS WAS FOUND TO BE DECENTERED. WHEN THE PT WAS LYING FLAT, THE IOL WAS IN CORRECT POSITION. WHEN THE PT SAT UPRIGHT, THE CAPSULAR BAG AND THE LENS DESCENDED DOWN WARD. THE PT WAS AGAIN TAKEN TO SURGERY TO REMOVE THE LENS TWO DAYS AFTER THE INITIAL IMPLANT. A MODEL UV65B/+14.5 (D) WAS IMPLANTED WITH NO PROBLEM AND THE PT HAS SINCE RECOVERED. SHE DID NOT BELIEVE THE EVENT WAS DUE TO THE LENS, BUT TO WEAK ZONULES. NO FURTHER INFO IS EXPECTED.
CODE 81. NO LENS EVAL OR INVESTIGATION DONE AS EVENT WAS NOT LENS RELATED.
THE BALLOON ON THE CATHETER WOULD NOT INFLATE IN SITU. THERE WERE NO REPORTED COMPLICATIONS.
THE PUMP WAS BEING USED TO DELIVER A FIBER-CONTAINING ENTERAL FEEDING SOLUTION IN A PRE-FILLED CONTAINER AT 100 ML/HR. THE 8 FRENCH FEEDING TUBE BEING USED (PLACED SURGICALLY AS A JEJUNOSTOMY ON 9/9/) BECAME MINIMALLY OCCLUDED ON 9/25, AND PUMP DELIVERED LESS THAN ORDERED WITH NO OCCLUSION ALARM. THE PT'S BLOOD SUGAR DROPPED TO 50 MG/DL ON 9/25/96 SINCE INSULIN WAS BEING DELIVERED BY IV PUMP. AT LEAST THREE ENTERAL PUMPS WERE TRIED, BUT THE FEEDING SOLUTION COULD ONLY BE DELIVERED AT 100 ML/HR EVEN IF THE PUMP WAS SET AT 200 ML/HR. THE FEEDING TUBE HAD BEEN FLUSHED WITH WATER EVERY 4 HRS THROUGHOUT FEEDING. WHEN FLUSHED EVERY 8 HRS WITH COLA, THE PUMP FED AS DESIRED. THE PUMPS WERE PLUGGED IN FOR AT LEAST 23 HOURS/DAY. NO OCCLUSION ALARMS WERE HEARD ON THESE PUMPS.
2343 -LABELED (LABELED IN CORRESPONDING ADMINISTRATION SET LABELING). CO STANDARD PROCEDURE INCLUDES SENDING THE REPORTER A MEDWATCH FORM FOR COMPLETION AND RETURN. IN THIS CASE, THE REPORTER DID NOT PROVIDE THE REQUIRED INFO FOR SECTION F2 AND F10.
DURING A PROCEDURE, THE LID OF THE FOOTPEDAL BECAME LOOSE THUS ACTIVATING THE FOOTPEDAL AT A MOST INAPPROPRIATE TIME(MOMENTARILY UNABLE TO COAGULATE VESSEL.)
THE DOUBLE FOOTPEDAL RETURNED TO US WAS IN EXCESS OF THIRTEEN YEARS OLD. ONE OF THE FOOTPEDALS IN THE ASSEMBLY (NOW DISCONTINUED) HAD BEEN REPLACED WITH ANOTHER ONE OF THE CO'S FOOTPEDALS AND WAS SLIGHTLY MODIFIED TO PERFORM IN THE DOUBLE UNIT. THE REPLACEMENT FOOTPEDAL USED IS CONSIDERED ACCEPTABLE. THE INSTALLATION AND MODIFICATION OF THIS SUBSTITUTE FOOTPEDAL IS NOT BELIEVED TO HAVE HAD ANY AFFECT ON THE REPORTED FAILURE. THE RETAINING CLIPS USED TO HOLD THE FOOTPEDAL COVER IN PLACE BROKE. IT APPEARS THAT ALTHOUGH THE FOOTPEDAL WITH THE BROKEN RETAINING CLIPS WAS A REPLACEMENT, THE UNIT HAD UNDERGONE FREQUENT USAGE AMD MAY POSSIBLY HAVE ENCOUNTERED ROUGH TREATMENT WHICH CAUSED THE CLIPS TO BREAK. THE UNIT WAS THOROUGHLY CLEANED, NEW RETAINING CLIPS INSTALLED, SOME WORN PARTS REPLACED, AND IT HAS BEEN RETURNED TO THE CUSTOMER.
THE SWITCH REMAINED IN THE "ON POSITION AND EMITTED SPARKS. THE USER INDICATED THE ELECTRIC CORD WAS BROKEN. NO DEATHS OR INJURIES WERE REPORTED. THE USER HAS NOT RETURNED THE UNIT FOR INSPECTION AND MAY NOT RETURN IT. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BEACUSE OF SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT GREATER THEN LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS SEVERITY  OF THIS EVENT GREATER THAN LABELED? N.
DURING SCENE; PADS WOULD NOT PEEL APART, AND CUSTOMER HAD A PROBLEM ATTACHING THESE PADS TO THE PT. MALE AGE 73 WAS FOUND TO BE IN CARDIAC ARREST, UNIT WAS HOOKED UP AND PADS FAILED. FINALLY PADS WERE PLACED ON PT, UNIT DELIVERED 1 SHOCK. PT PRONOUNCED AT HOSP OR IN FIELD, CUSTOMER WAS NOT SURE. THE CAPTAIN INVOLVED AT THE SCENE, SAID THAT THE PADS DID NOT AFFECT PT OUTCOME.
AFTER 8 HRS OF USE LEAKAGE WAS OBSERVED BY THE CLINICAL STAFF. THE DEVICE WAS CHANGED OUT AND NO PT INJURY WAS OBSERVED. DEVICE WAS DISPOSED OF BY HOSPITAL PERSONNEL AND WAS UNAVAILABLE FOR COMPLAINT EVALUATION.
THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFORMATION OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AND ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIVISION, ITS OFFICERS, EMPLOYEES, OR AGENTS.
IT WAS REPORTED THAT THE INFUSION PUMP WAS OPERATING BUT NOT DELIVERING FLUID. REPORTEDLY A TPA DRIP WAS STARTED ON THE PUMP IN THE ER. THE PT WAS TRANSFERRED TO THE ICU AND IT WAS NOTED THAT THERE WAS NO DRIPPING AND NO FLUID HAD BEEN DELIVERED. APPROX. 65 ML SHOULD HAVE INFUSED OVER THE LAST 30 TO 60 MIN. THE PUMP WAS REMOVED FROM THE PT AND THE TPA WAS INFUSED WITH A DIFFERENT PUMP. NO ADD'L INTERVENTION WAS REQUIRED.
SECTION F COMPLETED BY THE MFR. EVALUATION SUMMARY: FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION. NO ABNORMALITIES WERE FOUND WITH THE OPERATION OF THE PUMP. THE MOST LIKELY CAUSE OF THE REPORTED OCCURRENCE WAS IMPROPER LOADING OF THE IV TUBING INTO THE INFUSION PUMP.
CODE 86: EVALUATION OF EVENT BASED ON MFG AND QC PROCEDURE, AND HISTORY OF DEVICE RELATED TO CONTENT OF THIS EVENT DESCRIPTION. THIS INFO WAS REPORTED TO CO CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. PRODUCT WAS USED IN THE RCFA FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE. THE PROCEDURE WAS NOT SUCCESSFUL AND MANUAL COMPRESSION AND A FEMORAL COMPRESSION WERE REQUIRED TO ACHIEVE HEMOSTASIS. A WEEK LATER THE GROIN WAS STILL BRUISED. IN APPROX ANOTHER TWO WEEKS, THE PT COMPLAINED OF SEVERE BURNING PAIN IN THE RIGHT LEG. ULTRASOUND SHOWED A PSEUDOANEURYSM IN THE GROIN WHERE PRODUCT HAS BEEN USED WHICH REQUIRED SURGICAL REPAIR. CODE 68: SINCE PRODUCT WAS NOT SUCCESSFULLY DEPLOYED AND THIS PSEUDOANEURYSM OCCURRED ALMOST THREE WEEKS FOLLOWING THE CARDIAC CATHETERIZATION PROCEDURE, CO CAN NOT ATTRIBUTE THIS EVENT TO THE USE OF THE PRODUCT.
A PRESSURE IRRIGATOR DOOR/COVER CRACKED UNDER PRESSURE OF APPROX. 550MLHG. A PIECE OF THE DOOR FULLY SEPARATED FROM THE COVER ALONG THE BOTTOM HALF OF THE LATCH SIDE OF THE DOOR & "FLEW ACROSS THE FLOOR".
AS A RESULT OF IN-HOUSE TESTING & FILED REPORTS, ADM/MMI INITIATED RIGOROUS R & D TESTING FOR PREMATURE FAILURE OF THESE COVERS(DOORS), IN NOV.95. TEST DATA TO DATE SHOWS THAT THIS TYPE OF FAILURE CAN BE REPLICATED BY EXPOSURE TO AGGRESSIVE CLEANING/DISINFECTANT AGENTS. ADD'L TESTING FOR ROOT CAUSES, ROBUST DESIGN CHANGES, CONTINUES. MOLD TOOLING WAS EVALUATED & MODIFIED & A FORMAL VALIDATION IS IN-PROCESS. IN COORDINATION WITH LOCAL/DISTRICT OFFICES OF FDA, A SAFETY ALERT LETTER HAS BEEN SENT TO HOSPITALS; NEW PRODUCT SHIPMENTS CEASED (7/16/96)UNTIL AN ACCEPTABLE COVER IS VALIDATED. REPAIRS TO THE EXISTING CUSTOMER BASE CONTINUE, USING QUALIFIED REPLACEMENT COVERS ON AN INTERIM BASIS, & MODIFIED LABELING IS BEING DEVELOPED. FREQUENCY: HIGHER THAN EXPECTED. SEVERITY: AS EXPECTED FOR TYPE OF BREAK.
ACCOUNT REPORTS ONE INCIDENT IN WHICH THE PILOT LINE SEPARATED FROM THE ENDOTRACHEAL TUBE, BEFORE PT USAGE. LINE WAS NOT TUGGED ON.
SAMPLE WAS INADVERTENTLY DISCARDED BY CUSTOMER. NO FURTHER FOLLOW-UP TO BE CONDUCTED.
EVAL OF THE RETURNED ELECTRODES PADS WAS DONE BY A QUALITY ASSURANCE ENGINEER AT DISTRIBUTOR. THE RELEASE LINERS WERE VERIFIED TO REMAIN STUCK TO THE ELECTRODES WHEN THE RELEASE TAB WAS INITIALLY PULLED ON THE EIGHT PAIRS OF ELECTRODES. HOWEVER ALL OF THE RELEASE LINERS COULD BE REMOVED IF THE WHITE ADHESIVE RING WAS FIRST PARTIALLY ROLLED AWAY FROM THE RELEASE LINER WITH A ROLLING THUMB MOTION BEFORE THE PULL TAB WAS USED TO REMOVE THE RELEASE LINER. NO OTHER FOLLOWING THIS EVAL. THE ABOVE ELVAL CODES WERE DETERMINED BY DISTRIBUTOR.
AFTER STENT PLACEMENT, DR ATTEMPTED TO IRRIGATE PT. DR WAS UNABLE TO IRRIGATE AND ELECTED TO REOPEN THE PT AND PLACE ANOTHER STENT.
ATTEMPTS WERE MADE BY TELEPHONE TO OBTAIN INFO REGARDING THIS INCIDENT. SIX TELEPHONE CALLS WERE MADE FROM 9/26/96 TO 10/29/96. ONE CALL RESULTED IN BEING DIRECTED TO SOMEONE ELSE. IN THE OTHER FIVE CALLS MESSAGES WERE LEFT BUT NO RETURN CALLS WERE RECEIVED. THE STENT WAS MFG IN 7/95. NO OTHER SAMPLES FROM THIS LOT REMAIN IN INVENTORY. AT THE TIME THIS STENT WAS MFG QUALITY CONTROL INSPECTION WAS PERFORMED ON AN AUDIT BASIS. SINCE 1/96 ALL LOTS ARE INSPECTED BY QUALITY CONTROL USING A SAMPLING PLAN.
SWITCH EMITTED SMOKE. INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROX 1967 TO 6/21/90, CO USED A SWITCH MFG BY A REPUTABLE FIRM. THE SWITCH WAS A MOMENTARY TYPE SWITCH WITH A SPRING LOADED LEVER WHICH REQUIRED BEING HELD IN THE "ON" POSITION TO MAKE CONTACT. SOMETIMES A USER WOULD NOT FULLY ENGAGE THE LEVER, ALLOWING THE CONTACTS TO REMAIN SLIGHTLY OPEN WHICH COULD INDUCE ARCING. THEN CONSISTENTLY HELD IN THIS WAY, CARBON BUILD-UP FROM THE ARCING COULD REACH OPPOSITE POLES CAUSING THE SWITCH TO EMIT A SMALL AMOUNT OF SMOKE. CO'S FIRST SOLUTION WAS TO CHANGE THE CONTACT MATERIAL AND THE BODY OF THE SWITCH. THIS REDUCED THE ARCING OF THE CONTACTS AND THE CARBON TRACKING OF THE SWITCH BODY. ALTHOUGH THE SITUATION WAS IMPROVED, THE OCCASIONAL RELEASE OF A PUFF OF SMOKE WAS POSSIBLE. ON 6/21/90, CO BEGAN USING A SNAP ACTION SWITCH WHICH IS DOES NOT ALLOW THE CONTACTS TO BE HELD IN A SLIGHTLY OPEN POSITION. THIS EVENT IS NOT REPORTABLE UNDER 21CFR803 BECAUSE SIMILAR EVENTS WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO BE COMPLIANT WITH REGULATORY LETTER 90-DT-12. REMEDIAL ACTION HAS BEEN COMPLISHED.
IS FREQUENCY OF THIS EVENT ADDRESSED IN THE DEVICE LABELING?Y. IS FREQUENCY OF THIS EVENT GREATER THAN LABELED?N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELED?Y. IS SEVERITY OF THIS EVENT GREATER THAN LABELED?N.
THE FEMALE LUER CRACKED DURING USE. THE REPORTER IS A DISTRIBUTOR. EVENT OCCURRED AT TEACHING HOSPITAL.
ONE UNIT WAS RETURNED TO CO. FOR EVALUATION. THEIR EVALUATION SHOWED THAT THE FEMALE LUER WAS CRACKED. THE RETURNED UNIT WAS NOT FORWARDED TO CO. FOR EVALUATION. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED. THE SUB ASSEMBLY COMPONENT PART IN QUESTION IS A FEMALE LUER. THIS COMPONENT BECOMES INCORPORATED INTO THE FINISHED PRODUCT WHICH WAS INVOLVED IN THIS EVENT. THE COMPONENT IS MOLDED BY CO. AND SUPPLIED TO A SUBSIDIARY OF THE CO. THE FINISHED PRODUCT IS MANUFACTURED, PACKAGED AND STERIZED BY THE CO.
REPORTER STATED THAT USER AT ACCOUNT REPORTED THAT WHEN SHE PUSHED THE AUTO ID BUTTON, THE SOLUTION ID THAT WAS SET FOR STATION 2 DID NOT SHOW UP IN THE DISPLAY. THE SOLUTION WAS MOVED TO STATION 3 AND THEN ALL THREE SOURCE SOLUTIONS WERE PUMPED AS PROGRAMMED. SINCE THE SITUATION ON STATION 2 WAS NOT RESOLVED, THE USER WAS ADVISED NOT TO USE THE UNIT WHICH WAS SWAPPED OUT. THE BAG THAT WAS COMPOUNDED WAS FOR TRAINING PURPOSES ONLY, SO THERE WAS NO PT INVOLVEMENT.
SECTION F COMPLETED BY CO, BASED ON INFO RECEIVED FROM REPORTER. EVALUATION: THE UNIT WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
STAFF RESPONDED TO IV ALARM. MACHINE FLASHED "AIR". ON ASSESSING IV FLUIDS, FOUND ENTIRE BAG OF HEPARIN INFUSED SINCE PREVIOUS CHECK (APPROX. 30 MIN.). ORANGE CLAMP FOUND IN PROPER POSITION, BUT VERY LOOSE. HEPARIN TO BE INFUSED AT 14CC/HR, RATE PROPERLY SET.
RESULT CODES NOT ASSIGNED BECAUSE PUMP WAS NOT RETURNED FOR EVAL. HOSPITAL'S BIOMED TESTED THE PUMP AND NO FAULT WAS FOUND. THE HOSPITAL SUSPECTS POSSIBLE MISLOAD OF THE IV SET. ADD'L INSERVICING HAS BEEN SCHEDULED ON PROPER LOADING OF THE IV SET PER THE DIRECTION FOR USE. SECTIONS A-E ARE PER THE ATTACHED VOLUNTARY MEDWATCH REPORT RECEIVED FROM THE HOSPITAL WITH CORRECTIONS MADE TO SECTIONS D-2, AND 6 TO REFLECT THE CORRECT BRAND NAME, TYPE OF DEVICE AND SERIAL NUMBER. SECTION D-9 ON VOLUNTARY MEDWATCH REPORT INDICATES PUMP IS AVAILABLE FOR EVAL, HOWEVER THE HOSPITAL IS NOT RETURNING TO THE MFR. SECTION F WAS COMPLETED BY THE MFR. MFR REPORT DATE 9/18/96.
THE PRODUCT WAS BEING USED IN AN ANESTHESIA MACHINE AND THE ABSORBENT WAS NOT ABSORBING THE CO2 FULLY.
CO DID NOT RECEIVE THE PRODUCT, BUT DID RECEIVE THE PART NUMBER AND LOT NUMBER OF THE PRODUCT THAT WAS INVOLVED. A REVIEW OF DOCUMENTATION INDICATES THAT THE CUSTOMER HAD USED THE INCORRECT CANISTER SIZE. ALLIED MFRS TWO DIFFERENT SIZES OF CANISTERS OF ABSORBENT THAT ARE USED FOR DIFFERENT SIZES OF ANESTHESIA MACHINES, THE END-USER HAD USED THE INCORRECT SIZE. THE FILING OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ALLIED HEALTHCARE PRODUCTS, INC. (AHP) ONE OF ITS DEVICES HAS CAUSED OR CONTRIBUTED TO THE DEATH OR SERIOUS INJURY OR THAT ONE OF ITS DEVICES HAS MALFUNCTIONED. FURTHERMORE, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE REPORT CONCERNS AN AHPI PRODUCT UNLESS AND UNTIL AHPI HAS VERIFIED THAT FACT BY PHYSICAL EXAM OF THE PRODUCT INVOLVED.
RN ATTEMPTED TO INSERT NG TUBE AND PLACEMENT WAS WRONG. NG TUBE PUNCTURED THE RIGHT LUNG. THE PT REQUIRED ADD'L HOSP.
THE CUSTOMER HAS  INFORMED CO THAT THE INCIDENT THAT OCCURRED WAS NOT IN ANY WAY RELATED TO THE DEVICE. RATHER IT WAS USER ERROR IN PLACING THE TUBE. ACCORDINGLY THEY REQUESTED THAT CO CLOSE THIS FILE. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
A 75 Y/O PT WAS ADMITTED THROUGH ER HAVING SUSTAINED A VASCULAR COLLAPSE AND SUBSEQUENT V-TACH. IN STABILIZING THE PT, A PACER WAS UTILIZED. IT WAS UNPLUGGED AND PLACED ON BATTERY FOR TRANSPORTING THE PT TO CCU. DURING TRANSPORT, THE PACER WOULD NOT CAPTURE. THE PT EXPIRED. WITH THIS PACER, "LOW BATTERY" DISPLAY WOULD ONLY BE EVIDENT FOR THE MONITOR AND NOT THE PACER. "LOW BATTERY" WAS NOT OBSERVED FOR THE MONITOR'S BATTERY. IT IS NOT KNOWN WHETHER THE ABOVE AFFECTED PT OUTCOME.
REPORTER STATED THAT USER REPORTED THAT UNIT HAD AN OBSERVED FREE FLOW OF APPROX. 2ML. DURING THIS SAME TIME THE UNIT ALSO DISPLAYED P-22 AND P-17 ALARMS. THE USER WAS ADVISED NOT TO USE THE UNIT WHICH WAS SWAPPED OUT. NO PT INVOLVEMENT.
SECTION F COMPLETED BY CO, BASED ON INFO OBTAINED FROM REPORTER. EVALUATION: THE UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
DURING PRIMING OF THE EXTRACORPOREAL CIRCUIT, IT WAS NOTED THAT A PORTION OF THE COATING ON THE TUBING HAD PARTIALLY PEELED AWAY FROM THE SURFACE. BASED UPON THIS FINDING, THE PRODUCT WAS NOT USED. THERE WERE NO REPORTED PT INJURIES OR ISSUES REGARDING THIS SITUATION.
PRELIMINARY EVALUATION HAS BEEN PERFORMED. FOURIER TRANSFORM-INFRARED SPECTROMETRY (FTIR) ANALYSIS WAS PERFORMED ON THE PVC TUBING BOTH INSIDE AND OUTSIDE AND ON THE DELAMINATED PART. SCANNING ELECTRON MICROSCOPY (SEM) SHOWED FAIRLY LARGE SECTIONS OF "COATING" THAT WERE PEELING AWAY FROM THE TUBING. A TOLUIDINE BLUE STAINING TECHNIQUE WAS ALSO PERFORMED TO CONFIRM BARE SPOTS AND AREAS WHERE THE COATING WAS REMOVED OR DELAMINATED.
THE VENTILATOR WAS SET TO DELIVER 75% FIO2. THE VENTILATOR SPONTANEOUSLY DROPPED THE CONCENTRATION TO 60-62%. THE PT BEGAN TO DESATURATE AND THE FIO2 WAS INCREASED TO 100%. THE CONCENTRATION ROSE TO 85% AND STOPPED.
THE VENTILATOR WAS EVALUATED BY THE HOSPITAL. THE RESULTS FOUND THE FACILITY'S OXYGEN SYSTEM WAS THE CAUSE OF THE FAILURE.
CODE 86: EVALUATION OF EVENT BASED ON MFG AND QC PROCEDURES, AND HISTORICAL USE OF DEVICE RELATED TO THIS EVENT. THIS INFO WAS PROVIDED TO A CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. CO WAS USED IN THE RCFA FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE WITH NO COMPLICATIONS. APPROXIMATELY 2 WEEKS LATER THE PT PRESENTED TO HOSP COMPLAINING OF A BURNING PAIN IN THE PRODUCT AREA OF THE GROIN. PSEUDOANEURYSM REQUIRING SURGICAL REPAIR WAS DIAGNOSED. PSEUDOANEURYSMS CAN RESULT IF THE COLLAGEN IS NOT PLACED ACCURATELY OVER THE ARTERIAL PUNCTURE SITE. HOWEVER, THIS COMPLICATION IS NOT UNUSUAL FOLLOWING CARDIAC CATHETERIZATION PROCEDURES. THEREFORE, CO CAN NOT ATTRIBUTE THIS EVENT TO THE USE OF PRODUCT.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP A FEW STAPLES COME OUT BUT THE STAPLER DID NOT CUT THEREFORE IT GOT JAMMED IN THE TISSUE. THERE WAS NO PT CONSEQUENCE.
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
H6:68 OTHER (USE OF EXCESSIVE BONE CEMENT CONTRIBUTED TO THE EVENT.
THE SWITCH REMAINED IN THE "ON" POSITION. THE UNIT HAS NOT RETURNED TO CO TO BE INSPECTED AND MAY NOT BE. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? N.
WHILE INTRA-AORTIC BALLOON CATHETER IN USE IN PT, THE BALLOON RUPTURED. THE CATHETER WAS REMOVED TO PREVENT FURTHER INDUCTION OF HELIUM INTO PT. THE CATHETER WAS NOT RE-INSERTED INTO PT.
THE STEM EXTENSION COMPONENT OF THE KNEE TIBIAL PROSTHESIS APPEARS TO BE POSSIBLY DISASSOCIATED ON THE PT'S RADIOGRAPHS. NO INJURY TO THE PT HAS OCCURRED BECAUSE OF THIS EVENT.
THE TUBING SEPARATED FROM THE MALE LUER LOCK.
ONE UNIT RETURNED FOR EVALUATION. EXAMINATION SHOWED THAT THE TUBING HAD NOT BEEN SOLVENT BONDED TO THE LUER LOCK. THIS COMPONENT IS ASSEMBLED BY AUTOMATED MACHINARY. MAINTENANCE HAS BEEN NOTIFIED AND IS TAKING CORRECTIVE ACTION. LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. THE SUB ASSEMBLY COMPONENT PART IN QUESTION IS A MONITORING LINE. THIS COMPONENT BECOMES INCORPORATED INTO THE FINISHED PRODUCT WHICH WAS INVOLVED IN THIS EVENT. THE COMPONENT IS ASSEMBLED BY THE CO. AND SUPPLIED TO A SUBSIDIARY OF THE CO. THE FINISHED PRODUCT IS MANUFACTURED, PACKAGED AND STERILIZED BY THE CO.
THE PENCIL SELF ACTIVATED IN THE COAG MODE. THE PENCIL HAS BEEN RETURNED TO CO; HOWEVER, THE EVALUATION IS NOT COMPLETE.
FOUR PENCILS WERE RETURNED FOR EVAL AND THREE OF THE FOUR WERE FOUND TO BE NON-FUNCTIONAL DUE TO DEPOSITS UNDER THE SWITCHING DOME. THE FOURTH PENCIL WAS CONFIRMED TO SELF-ACTIVATE BECAUSE OF A CRUSHED DOME IN THE INTERNAL SWITCHING MECHANISM. THE VALLEYLAB ENGINEERING DEPARTMENT TRIED TO REPLICATE THIS FAILURE MODE. THE ONLY WAY TO REPLICATE THIS FAILURE IS THROUGH A MISUE CONDITION. THE CAUSE OF THIS FAILURE MODE WAS UNDETERMINED.
JANUARY OF 1996, THE INDIVIDUAL WAS DIAGNOSED WITH LATEX ALLERGY, RESULTING IN ITCHING, RESPIRATORY PROBLEMS, SWELLING, BLISTERS, RASHES, ETC.
MEDWATCH FORM ISSUED TO COMPLY WITH FDA MEDICAL DEVICE REPORTING REQUIREMENTS. INVESTIGATION OF THE LATEX ALLERGY CLAIM COULD NOT BE CONDUCTED AS NEITHER LOT NUMBERS, PRODUCT NUMBERS, OR SAMPLES WERE AVAILABLE. THE USER WAS ALSO KNOWN TO USE LATEX PRODUCTS PROVIDED BY OTHER MFRS AS WELL.
APPROX. 1 MINUTE AFTER STARTING THE TREATMENT, BLOOD WAS NOTICED DRIPPING AT THE JUNCTION SITE OF THE HEPARIN ADMINSTRATION TUBING AND THE MAIN ARTERIAL LINE. THE PT'S BLOOD WAS RINSED BACK AND THE BLOOD LINES WERE DISCARDED. THE PT'S TREATMENT WAS RESTARTED WITHOUT FURTHER PROBLEM. THE DIRECTOR OF NURSING AND THE CHARGE NURSE WERE NOTIFIED. THE PT LOST ABOUT 30-50 CC'S OF BLOOD.
A BLADDER NECK SUSPENSION PROCEDURE WAS PERFORMED ON 9/23. SOME TIME POST PROCEDURE, THE PT RETURNED IN PAIN. A CT SCAN REVEALED BOTH ANCHORS HAD DISLODGED AND WERE FREE FLOATING, THE ANCHORS WERE SURGICALLY REMOVED ON 10/11. TO DATE, NO FURTHER TREATMENT HAS OCCURRED,. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. NO FURTHER DETAILS ARE AVAILABLE. THEREFORE, CO IS UNABLE TO DETERMINE THE CAUSE FOR THIS EVENT.
THE BONE SCREW COMPONENT OF THE SPINE INSTRUMENTATION CONSTRUCT BROKE. NO OTHER INFO PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO  A DEATH OR INJURY. THIS DOCUMENT IS IN NO WY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY ORTHOPAEDICS, INC. OR ITS AFFILIATES.
PT WAS SEEN FOR SEVERE PAIN AND DIFFICULTY WALKING. X-RAYS REVEALED A FRACTURE OF PROSTHESIS AND THE PROXIMAL PART OF THE FEMORAL PROSTHESIS WAS LOOSE. PT WAS ADMITTED FOR REVISION TOTAL HIP. BROKEN FEMORAL STEM WAS REMOVED AND REPLACED WITH NEW PROSTHESIS.
PT UNDERWENT CATARACT SURGERY ON 10/9/96, AND IMPLANTATION OF INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON NOTICED THAT DURING INSERTION THE HAPTIC WAS FOUND TO BE BENT. AS THE SURGEON REMOVED THE LENS, THE POSTERIOR CAPSULE TORE. A VITRECTOMY WAS NECESSARY. NO OTHER SURGICAL PROCEDURES WERE DONE AND NO COMPLICATIONS WERE NOTED. OTHER THAN THE DIAGNOSED CATARACT, THERE WERE NO PRE-EXISTING CONDITIONS. THE SURGEON SAID THAT THE PT IS DOING EXCELLENT.
RESULTS: THE LENS HAPTICS POSSESS THE PROPER CURVATURE AND ANGULATION. ONE HAPTIC WAS TORQUED BEYOND SPECS. HOWEVER, THIS MAY HAVE OCCURRED DURING EXPLANTATION. THE PT'S PREOPERATIVE VISUAL ACUITY WAS 20/60 WITH BEST CORRECTED LENSES. POSTOPERATIVE VISUAL ACUITY TO DATE ON LAST EXAMINATION ON 10/24/96 IS 20/60 AND HER IOP IS 16MM HG. THE SURGEON SAID THAT THE PT IS DOING EXCELLENT. LENS BOX WAS RECEIVED. THE BOX CONTAINED 6 CHART LABELS, THE PT ID CARD, PT REGISTRATION CARD, AND LENS POUCH. THE LENS POUCH CONTAINED THE LENS TRAY. THE LENS TRAY CONTAINED THE BASE AND TOP INSERTS, WITH THE LENS LOCATED IN BETWEEN THE INSERTS. THE LENS WAS REMOVED FROM THE TRAY AND INSPECTED FOR GENERAL DEFECTS. THE LENS HAS DRIED BSS/VISCOELASTIC-TYPE RESIDUE. THE HAPTICS POSSESS THE PROPER CURVATURE AND ANGULATION. ONE HAPTIC IS TORQUED BEYOND SPECS. HOWEVER, THIS MAY HAVE OCCURRED DURING EXPLANTATION. THE LENS WAS REPLACED DUE TO A TORN CAPSULE AND VITRECTOMY.
WHILE UNDERGOING SURGERY, PT DEVELOPED HIGH CO LEVEL-CARBOXHYGB OF 58. THE INVOLVED ANESTHESIA MACHINE HAD NOT BEEN USED FOR A PERIOD OF 36 TO 48 HOURS. THE PT SUFFERED NO UNTOWARD EFFECTS. REPORTS WERE MADE IMMEDIATELY TO THE DEPT OF HEALTH. THE ANESTHESIA MACHINE WAS TAKEN OUT OF SERVICE. A MEDWATCH REPORT WAS IMMEDIATELY MADE TO THE MFR OF THE MACHINE. THEY HAVE SINCE CALLED AND HAVE STATED THAT THEY FELT THE CAUSE OF THE PROBLEM WAS CARBON MONOXIDE. ONGOING INVESTIGATION HAS RESULTED IN THE CONCLUSION THAT THE EVENT WAS A RESULT OF THE REACTION BETWEEN DRY CARBON MONOXIDE AND DESFLURANE. THE CANISTER OF CARBON MONOXIDE INVOLVED HAVE BEEN SENT TO DR FOR FURTHER TESTING.
CO COULD NOT PERFORM A PRODUCT ANALYSIS, SINCE THE PRODUCT WAS NOT RETURNED TO CO. CO DOES NOT INTEND TO SUBMIT ADD'L INFO. CO DOES NOT BELIEVE THE FREQUENCY OR SEVERITY OF THIS EVENT IS GREATER THAN USUAL FOR THIS DEVICE. THE FILING OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ALLIED HEALTHCARE PRODUCTS, INC. (AHPI) ONE OF ITS DEVICES HAS CAUSED OR CONTRIBUTED TO THE DEATH OR SERIOUS INJURY OR THAT ONE OF ITS DEVICES HAS MALFUNCTIONED. FURTHERMORE, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE REPORT CONCERNS AN AHPI PRODUCT UNLESS AND UNTIL AHPI HAS VERIFIED THAT FACT BY PHYSICIAL EXAM OF THE PRODUCT INVOLVED.
USER REPORTED AN ALARM DURING SELF TEST PROCEDURE DURING SET-UP FOR A PT. ALARM (VENT FAULT 03) INDICATED A DEVICE MALFUNCTION PREVENTING DEVICE USE. THERE WAS NO PT INJURY.
FREQUENCY AND SEVERITY OF THIS EVENT ARE NOT ADDRESSED IN THE DEVICE LABELING AND ARE NOT GREATER THAN USUAL. THE FILING OF THIS REPORT DOES NOT REFLECT A CONCLUSION BY BUNNEL INCORPORATED THAT THE REPORT SHOWS THE DEVICE IS DEFECTIVE, NOR DOES IT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
WHEN THE PHLEBOTOMIST OPENED NEEDLE, NEEDLE CAME OUT OF THE CASING STICKING PT IN THE ARM, THEN STICKING PHLEBOTOMIST IN THE SNEAKER.
SECTIONS A THROUGH F COMPLETED BY MFR'S REPORTING SITE. BASELINE TESTING GIVEN TO PHLEBOTOMIST AND PT. BLOOD WAS NOT INFECTIONS.
THERE WAS WHITE PARTICULATE IN THE SET WHICH WAS FOUND UPON PRIMING.
ONE UNIT RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED UNIT SHOWED A PIECE OF PLASTIC INSIDE THE DEVICE. THE PLASTIC IS LOOSE PARTICULATE FROM THE MOLDING PROCESS. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED PROCEDURES TO REDUCE PARTICULATE MATTER.
THE STEM EXTENSION COMPONENT OF THE KNEE TIBIA PROSTHESIS APPEARS TO POSSIBLY BE DISASSOCIATED ON THE PT'S X-RAYS. THERE IS NO INJURY TO THE PT REPORTED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES. D.6. -  MANUFACTURING LOT NUMBER WAS NOT PROVIDED TO CO. H.4. - MANUFACTURING DATE IS UNK BECAUSE THE MANUFACTURING LOT NUMBER WAS NOT PROVIDED TO CO.
LEFT HIP REPLACEMENT DONE 1992 UNCOMPLICATED PROCEDURE AND POST-OPERATIVE COURSE. FAILURE OF POLY LINER - WITH FRAGMENTATION WITHOUT HISTORY OF TRAUMA.
FACILITY ALLEGES VENOUS LINE PT CONNECTOR DISCONNECTED FROM SUBCLAVIAN CATHETER CONNECTION DURING DIALYSIS. RN REPORTS THAT DURING ROUTINE VS CHECK, PT COMPLAINED OF PAIN AT WHICH TIME BLOOD WAS NOTED ON FLOOR. STAFF NOTED THAT PT HAD BEEN MANIPULATING CATHETER AND BLOODINESS AND HAD BEEN WARNED NOT TO DO THIS. EBL > 100CC. PT TRANSFUSED WITH 2 UNITS PACKED CELLS. TREATMENT COMPLETED WITH NEW DIALYZER AND LINES. NO FURTHER MEDICAL INTERVENTION REPORTED.
EVALUATION RESULTS: TO EVALUATE THIS EVENT, DYNAMIC TESTS WERE CONDUCTED WHICH SIMULATED ACTIONS OR MOTIONS THAT MIGHT OCCUR DURING AN ACTUAL DIALYSIS TREATMENT. THE TESTING WAS PERFORMED WITH VARIOUS CATHETERS AND BLOODLINES AS WELL. THE RESULTS OF THE TESTING SHOWED THAT THE NMC PATIENT CONNECTOR HAD HIGHER HOLDING FORCES THAN MOST COMPETITORS AND WAS EQUIVALENT TO THE LEADING COMPETITOR IN THESE AREAS. THE RESULTS OF THE INVESTIGATION DETERMINED THAT USER ERROR CONTRIBUTED TO THE EVENT.
A PHYSICIAN WAS IN THE PROCESS OF APPLYING A FALLOPIAN TUBE CLIP TO A TUBE. WHEN THE APPLICATOR WAS MANIPULATED, THE CLIP WOULD NOT RE-OPEN TO ALLOW ATTACHMENT TO THE TUBE. THE APPLICATOR AND CLIP WERE WITHDRAWN FROM THE PT'S ABDOMEN. ANOTHER APPLICATOR WAS UTILIZED AND THE CLIP WAS SUCCESSFULLY APPLIED. NO PT PROBLEMS WERE REPORTED.
DATA IN SECTION F WAS FILLED IN BY THIS U.S. AGENT FOR THE FOREIGN MFR. THE INNER SHAFT SECTION OF THE DEVICE WAS FOUND TO HAVE A DOWNWARD BEND AT THE TIP. THIS DEVIATION COULD INTERMITTENTLY CAUSE A CLIP TO NOT RE-OPEN IN THE APPLICATOR AS IT SHOULD. THE CAUSE OF THE PROBLEM IS ATTRIBUTED TO USER INATTENTION TO MAINTENANCE OF THE PRODUCT.
ATTEMPTED TO PERFORM A CIRCUMCISION WITH CLAMP. STARTED PROCEDURE APPEARED TO BE PROBLEM REMOVED CLAMP LACERATION AT THE BASE OF THE SHAFT COMPLETELY ENCIRCLING THE PENIS THROUGH THE SKIN TISSUE ONLY.
CO COULD NOT PERFORM A PRODUCT ANALYSIS, SINCE THE PRODUCT WAS NOT RETURNED TO CO. CO DOES NOT INTEND TO SUBMIT ADD'L INFO. CO DOES NOT BELIEVE THE FREQUENCY OR SEVERITY OF THIS EVENT IS GREATER THAN USUAL FOR THIS DEVICE. THE FILING OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ALLIED HEALTHCARE PRODUCTS, INC.(AHPI) ONE OF ITS DEVICES HAS CAUSED OR CONTRBIUTED TO THE DEATH OR SERIOUS INJURY OR THAT ONE OF ITS DEVICES HAS MALFUNCTIONED. FURTHERMORE, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE REPORT CONCERNS AN AHPI PRODUCT UNLESS AND UNTIL AHPI HAS VERIFIED THAT FACT BY PHYSICAL EXAM OF THE PRODUCT INVOLVED.
THIS DISTRIBUTOR BECAME AWARE ON 10/22/96 OF AN INCIDENT THAT OCCURRED DURING PLACEMENT OF A SUBCLAVIAN PORT. THE PORT WAS SUCCESSFULLY PLACED. UPON REMOVAL OF THE GUIDE WIRE RESISTANCE WAS ENCOUNTERED AND A PORTION OF THE WIRE COATING SHEARED AND DETACHED IN THE PT'S SUBCLAVIAN VEIN. THE PT WAS BROUGHT TO THE CATH LAB WHERE RETRIEVAL OF THE DETACHED COATING WAS SUCCESSFUL UTILIZING A SNARE. THERE WERE NO PT COMPLICATIONS INVOLVED. NO FURTHER DETAILS COULD BE OBTAINED REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT.
DURING A DIALYSIS TREATMENT, THERE WAS AN EXTERNAL BLOOD LEAK AT THE SEALING PLUG ON THE ARTERIAL END OF THE DIALYZER. RINSEBACK WAS COMPLETED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE AFFECTED PRODUCT WAS DISCARDED BY THE FACILITY AND THEREFORE, IS UNAVAILABLE FOR ANALYSIS. WITHOUT THE AFFECTED PRODUCT, IT IS DIFFICULT TO DETERMINE THE EXACT CAUSE OF THE REPORTED PROBLEM. THE HAZARD TO PT SAFETY OF AN EXTERNAL BLOOD LEAK IS DIRECTLY RELATED TO ATHE VOLUME OF THE BLOOD LOSS AND THE PT'S CURRENT OR PAST CLINICAL HISTORY. BASED ON RETROSPECTIVE REVIEW OF EXTERNAL BLOOD LEAK COMPLAINTS, THERE IS A LOW LIKELIHOOD THAT LOSS OF THE EXTRACORPOREAL BLOOD CIRCUIT WILL RESULT IN AN INJURY. IN ADDITION, THE BLOOD LOSS, AS IN THIS CASE, IS MINIMAL. WITHOUT THE AFFECTED PRODUCT FOR INVESTIGATION, IT IS DIFFICULT FOR THE MFR TO DETERMINE THE EXACT NATURE OFTHE REPORTED PROBLEM. HOWEVER, THE MFR WILL CONTINUE TO MONITOR AND TREND. NO FURTHER REPORTING IS ANTICIPATED. A REVIEWW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT INDICATES THAT THE LOT WAS MFG ACCORDING TO MFR'S SPECIFICATIONS. CUSTOMER CONTACTED: N. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
THE MALE LUER LOCK WAS CRACKING AND BREAKING OFF. THE REPORTER INDICATED THAT THIS HAD OCCURRED ON TWENTY OCCASIONS BUT DID NOT PROVIDE SPECIFIC DETAILS.
THIS ISSUE IS A MOLDING DEFECT ASSOCIATED WITH THE IMPROPER PLACEMENT OF THE CORE PIN. THIS ISSUE HAS BEEN RESOLVED AND A QUALITY CONTROL TEST HAS BEEN IMPLEMENTED TO DETECT THIS ISSUE. THE ONE CASE OF PRODUCT BEING RETURNED TO THE CO. IS BEING REWORKED. THE LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE.
CIRCUMCISION PERFORMED WITH 1.3 CM CLAMP. IN THE PROCESS OF CIRCUMCISING, THE FORESKIN WAS BROUGHT UP THROUGH WHAT WAS BELIEVED TO BE A LOOSE/DETECTIVE CLAMP AND EXCESS TISSUE WAS REMOVED FROM THE VENTRAL SIDE OF THE PENIS. AFTER NOTICING THAT THE SKIN CONTINUED TO COME UP THROUGH THE CLAMP, THE CLAMP WAS ATTEMPTED TO BE REMOVED, BUT IT FELL OFF THE GLANS WITHOUT REMOVAL OF THE BOLT. ADEQUATE HEMOSTASIS WAS NOT PRODUCED BY THE CLAMP. PRESSURE APPLIED WITHOUT HEMOSTASIS. SILVER NITRATE ACHIEVED HEMOSTASIS.
FACILITY ALLEGES ARTERIAL LINE PT CONNECTOR DISCONNECTED FROM SUBCLAVIAN CATHETER ARTERIAL PORT DURING DIALYSIS. RN REPORTS AIR NOTED IN ARTERIAL LINE 1 1/2 HOURS INTO TREATMENT AND THEN DISCONNECTION DISCOVERED. BLOOD ASPIRATED FROM BOTH PORTS OF CATHETER; NO AIR SEEN IN VENOUS LINE. PT TRANSPORTED TO HOSP FOR OBSERVATION. DISCHARGED FROM HOSP SAME DAY. NO FURTHER MEDICAL INTERVENTION REPORTED. CATHETER REPORTED TO BE INTACT FOLLOWING INCIDENT.
INVESTIGATION IN PROGRESS. RESULT WILL FOLLOW.
CUSTOM HIP FEMORAL BROACH PROXIMAL SECTION SEPARATED FROM DISTAL CYLINDER WHILE SURGEON WAS USING IT IN A REVISION TOTAL HIP REPLACEMENT SURGERY. THIS RESULTED IN A DELAY OF APPROXIMATELY 15 MINUTES REQUIRED FOR SURGERY WHILE THE SURGEON REMOVED THE DISTAL END FROM THE FEMORAL CANAL.
INVESTIGATION REVEALED THAT USING A FULLY WELDED OR A FULLY WELDED AND THREADED JOINT RATHER THAN A POST AND TACK WELD WILL PREVENT REPEAT OCCURENCES. ON MONDAY, AUGUST 19, DR. PERFORMED A REVISION THR ON HIS PT WHILE DR WAS BROACHING THE FEMORAL BONE, THE BROACH SEPARATED FROM THE DISTAL CYLINDER OF THE BROACH. SINCE THE BROACH SEPARATED INTO TWO PIECES, DR. WAS NOT ABLE TO CONTINUE THE PROCEDURE WITH CO IMPLANT. HE COMPLETED THE PROCEDURE SUCCESSFULLY USING ANOTHER CO'S IMPLANT SYSTEM. THE BROACH SEPARATED IN SURGERY BECAUSE THE DISTAL CYLINDER WAS TACK WELDED TO THE BROACH. AS CORRECTIVE ACTION, A MEETING WAS CALLED BETWEEN THE DESIGN ENGINEERS AND THE MANUFACTURING VENDOR TO DISCUSS BETTER ALTERNATIVES FOR ATTACHING THE DISTAL CYLINDER TO THE BROACH. IT WAS DECIDED THAT THE DISTAL CYLINDER WILL BE THREADED INTO THE BRAOCH AND BOTH COMPONENTS WELDED AROUND THE JUNCTION. THIS ATTACHMENT WILL ASSURE THAT THE PARTS DO NOT SEPARATE DURING SURGERY.
THE AFFECTED PRODUCT WAS DISCARDED BY THE FACILITY AND THEREFORE, IS UNAVAILABLE FOR ANALYSIS. WITHOUT THE EFFECTED PRODUCT, IT IS DIFFICULT TO DETERMINE THE EXACT CAUSE OF THE REPORTED PROBLEM. THE HAZARD TO PT SAFETY OF AN EXTERNAL BLOOD LEAK IS DIRECTLY RELATED TO THE VOLUME OF THE BLOOD LOSS AND THE PT'S CURRENT OR PAST CLINICAL HISTORY. BASED ON RETROSPECTIVE REVIEW OF EXTERNAL BLOOD LEAK COMPLAINTS, THERE IS A LOW LIKELIHOOD THAT LOSS OF THE EXTRACORPOREAL BLOOD CIRCUIT WILL RESULT IN AN INJURY. IN ADDITION, THE BLOOD LOSS, AS IN THIS CASE, IS MINIMAL. WITHOUT THE AFFECTED PRODUCT FOR INVESTIGATION, IT IS DIFFICULT FOR THE MFR TO DETERMINE THE EXACT NATURE OF THE REPORTED PROBLEM. HOWEVER, THE MFR WILL CINTINUE TO MONITOR AND TREND. NO FURTHER REPORTING IS ANTICIPATED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT INDICATES THAT THE LOT WAS MFG ACCORDING TO MFR'S SPECIFICATIONS. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
CIRCUMCISION PERFORMED WITH 1.3 CM CLAMP. IN THE PROCESS OF CIRCUMCISION, THE FORESKIN WAS BROUGHT UP THROUGH WHAT WAS BELIEVED TO BE A LOOSE/DEFECTIVE CLAMP AND EXCESS TISSUE WAS REMOVED FROM THE VENTRAL SIDE OF THE PENIS. AFTER NOTICING THAT THE SKIN CONTINUED TO COME UP THROUGH THE CLAMP, THE CLAMP WAS ATTEMPTED TO BE REMOVED, BUT IT FELL OFF THE GLANS WITHOUT REMOVAL OF THE BOLT. ADEQUATE HEMOSTASIS WAS NOT PRODUCED BY THE CLAMP. PRESSURE APPLIED WITHOUT HEMOSTASIS, SILVER NITRATE ACHIEVED HEMOSTASIS.
CO COULD NOT PERFORM A PRODUCT ANALYSIS, SINCE THE PRODUCT WAS NOT RETURNED TO CO. CO DOES NOT INTEND TO SUBMIT ADD'L INFO. CO DOES NOT BELIEVE THE FREQUENCY OR SEVERITY OF THIS EVENT IS GREATER THAN USUAL FOR THIS DEVICE. THE FILING OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ALLIED HEALTHCARE PRODUCTS, INC.(AHPI) ONE OF ITS DEVICES HAS CAUSED OR CONTRIBUTED TO THE DEATH OR SERIOUS INJURY OR THAT ONE OF ITS DEVICES HAS MALFUNCTIONED. FURTHERMORE, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE REPORT CONCERNS AN AHPI PRODUCT UNLESS AND UNTIL AHPI HAS VERIFIED THAT FACT BY PHYSICAL EXAM OF THE PRODUCT INVOLVED.
EXPLANT REPORT STATED THAT PACE LEADS WERE CAPPED DUE TO A LEAD FRACTURE.
THE MALE LUER BROKE OFF DURING A PROCEDURE.
ONE UNIT RETURNED TO THE CO. FOR EVALUATION SHOWED THAT THE MALE LUER BROKE OFF. THIS ISSUE IS A MOLDING DEFECT ASSOCIATED WITH THE IMPROPER PLACEMENT OF THE CORE PIN. THIS ISSUE HAS BEEN RESOLVED AND A QUALITY CONTROL TEST HAS BEEN IMPLEMENTED TO DETECT THIS ISSUE. THE LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE.
THE SURGEON NICKED AN ARTERY IN THE PT'S LEG WITH A BLADE, CAUSING THE PT TO BLEED PROFUSELY.
DESCRIBE EVENT OR PROBLEM: PT INFECTION.
THE METAL TIP OF A LAPAROSCOPIC COAGULATION-SUCTION TUBE CAME OFF IN A PT'S ABDOMEN AS A LAPAROSCOPY WAS BEING DONE. THE METAL PIECE WAS RETRIEVED. NO PT INJURY OR OTHER PROBLEMS WERE REPORTED.
DATA IN SECTION F WAS FILLED IN BY THIS MFR. THE METAL TIP ON THE DISTAL END OF THE DEVICE WAS DETACHED. PROCESS USED TO ATTACH THE TIP TO THE SHAFT IS SILVER SOLDERING. INSPECTION OF THE SOLDER JOINT REVEALED THE SOLDER WAS NOT ADEQUATELY APPLIED DURING MANUFACTURE. PRODUCT WAS MADE IN 1992. LASER WELDING IS NOW EMPLOYED FOR THE ASSEMBLY PROCEDURE.
A BALLOON RUPTURED AT 8 ATMS DURING A SUPERFICIAL FEMORAL ANGIOPLASTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVIE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. MICROSCOPIC EXAM REVEALED A PIN-HOLE LEAK 2MM DISTAL TO THE PROXIMAL RO MARKER. SCRATCHES AND CHATTER MARKS WERE NOTED ON THE BALLOON SURFACE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES AND CHATTER MARKS ON THE BALLOON SURFACE. CO'S FOLLOW UP ALSO INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: "DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE CATHETERS THESE CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATION, IMMEDIATELY DISCONTINUE THE PRESSURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
H6- 86 (OTHER) MICROSCOPIC EXAM. INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
ERRATIC DIGOXIN II RESULTS WERE OBTAINED ON THE ANALYZER. ON AUGUST 7, 1996, THE CUSTOMER RECEIVED AN INITIAL RESULT OF 0.0 MG/ML AND A REPEAT RESULT OF 1.44 MG/ML. THE CUSTOMER CONFIRMED THE RESULT AND REPORTED OUT THE 1.44 MG/ML. NO REPORT OF INJURY.
INVESTIGATION SUMMARY: THE EVENT REPRESENTED IS NOT ADDRESSED IN THE DEVICE LABELING. A MALFUNCTION DID OCCUR. THIS REPORTABLE MDR EVENT WAS INVESTIGATED AS PART OF AN ONGOING STUDY OF THE AXSYM SYSTEM BY ABBOTT INTO THE CAUSATIVE REASON FOR MALFUNCTIONS. RESULTS OF THE INVESTIGATION YIELDED A NUMBER OF SYSTEM ENHANCEMENTS IMPLEMENTED ON CUSTOMER UNITS. IMPROVEMENTS INCLUDED AXSYM SYSTEM SOFTWARE VERSION 3.0 WITH ENHANCED ALGORITHM FOR FLUID DETECTION, NEW BUFFER TUBING AND SEAL FITTINGS WHICH REDUCED BUBBLES FORMING IN TUBING LINES, MODIFICATIONS TO THE LIQUID LEVEL SENSE BOARD TO DECREASE SENSITIVITY OF THE INSTRUMENT TO ELECTROSTATIC DISCHARGE, AND PACKAGING MODIFICATIONS FOR ADDED PROTECTION TO PROBES. IN ADDITION, ABBOTT HAS EMPHASIZED TO OUR CUSTOMERS THAT CORRECT OPERATING PROCEDURES MUST BE FOLLOWED TO ENSURE OPTIMAL PERFORMANCE OF THE AXSYM SYSTEM. AREAS THAT WERE EMPHASIZED INCLUDED PROBE CRASH RECOVERY PROCEDURE, RECOMMENDED TUBE SIZED AND TYPES, OPENING REAGENT BOTTLE 4, PROPER LOADING/UNLOADING OF REAGENT PACKS, AND ENSURING PROPER SAMPLE AND REAGENT HANDLING. THIS IS THE FINAL REPORT.
REAR S/F DAB PNTD R Q2. DEALER CLAIMS FRAME BROKE AT THE UPRIGHTS.
WHILE AMBULATING, PT EXPERIENCED A SUDDEN CRACK IN HIS HIP. X-RAY REVEALED BREAK IN CERAMIC HEAD OF HIP PROSTHESIS IMPLANTED IN 1995. PT REQUIRED SURGICAL REMOVAL AND REPLACEMENT WITH A NEW PROSTHESIS.
DURING BACK SURGERY THE CAUTERY PENCIL WOULD NOT ACTIVATE. THE STAFF TRIED 4 MACHINES BEFORE REALIZING THE PENCIL WOULD NOT WORK. THE HOSPITAL THEN REMOVED THE PENCIL AND REPLACED IT WITH ANOTHER ONE FROM HOSPITAL STOCK. THIS PENCIL DID WORK. THERE WAS NO PT INJURY, BUT THE ACCOUNT DID FEEL THAT THERE WAS A DELAY IN THE PROCEDURE.
MFR HAD MADE UNSUCCESSFUL ATTEMPTS TO OBTAIN PT INFORMATION. INVESTIGATION OF THE ABOVE REFERENCED COMPLAINT HAS BEEN COMPLETED. THE ORIGINAL COMPLAINT STATING THAT "DURING BACK SURGERY THE CAUTERY PENCIL WOULD NOT ACTIVATE. THE STAFF TRIED 4 ESU'S BEFORE REALIZING THE PENCIL WOULD NOT WORK. THE PENCIL WAS REMOVED AND REPLACED WITH ONE FROM STOCK. THERE WERE NO INJURIES BUT THE PROCEDURE WAS DELAYED."  WAS RECEIVED 08/09/96. THE INCIDENT PENCIL WAS RELEASED TO AN AFFILIATED CO SALES REPRESENTATIVE, BUT WAS NOT RETURNED TO CO IN TIME FOR THIS REPORT. CO DID FILE A MALFUNCTION MDR ON THIS EVENT BASED ON THE INFORMATION PROVIDED THAT THE DELAY IN SURGERY WAS A RESULT OF THE POSSIBLE NON-FUNCTIONING DISPOSABLE DEVICE AND REOCCURRENCE COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY. PREVIOUS LIKE PRODUCT TESTING HAS BEEN CONDUCTED AND THOSE PENCILS WERE DETERMINED TO HAVE BOTH MODES FUNCTIONING PROPERLY AND WITHIN EXPECTED MANUFACTURING RANGES FOR ACTIVATION FORCE. THE UPPER PORTION OF THIS RANGE HAS BEEN DETERMINED TO BE EXCESSIVE FOR THE END USER. IT WAS STATED BY THE STAFF AT THE INCIDENT HOSPITAL THAT 4 ESU'S FROM ANOTHER MANUFACTURER WERE TRIED PRIOR TO DETERMINING THAT THE PENCIL WAS THE PROBLEM. THE DELAY IN SURGERY WAS THE RESULT OF THIS PROBLEM IDENTIFICATION PROCESS. IT IS UNK WHETHER THE PENCIL IN QUESTION WAS DIFFICULT TO OPERATE OR WAS COMPLETELY NON-FUNCTIONAL. PREVIOUS TESTING HAS INDICATED THAT THE LIKELIHOOD IS THE PENCIL WAS HARD TO ACTIVATE BUT WOULD FUNCTION WITH A HIGHER ACTIVATION FORCE. WHILE THIS IS A SERIOUS PROBLEM TO THE USER, A HARD TO ACTIVATE PENCIL COULD HAVE BEEN USED TO COMPLETE ANY CRITICAL PORTION OF A PROCEDURE AND SWAPPED OUT BY THE STAFF AT A LATER TIME. THE USER IS REMINDED THAT GOOD ELECTROSURGERY PRACTICE INCLUDES AN EQUIPMENT CHECK OUT PRIOR TO SURGERY. IT WAS UNK IF THIS TEST WAS DONE, OR IF THE PENCIL FUNCTIONED PROPERLY DURING THIS CHECK OUT.
QR AXLE. DEALER CLAIMS BOTH AXLES HAVE BROKEN.
STAKING AT THE HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PARTE 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
A PT WAS UNDERGOING A LAPARSCOPIC TUBAL OCCLUSION PROCEDURE WITH FALLOPIAN TUBE CLIPS. ONE OF THE CLIPS CAME APART IN THREE PIECES IN THE ABDOMEN. ALL OF THE COMPONENT PARTS WERE RETRIEVED WITHOUT ANY OTHER PROBLEMS BEING REPEATED. ANOTHER FALLOPIAN TUBE CLIP WAS USED TO COMPLETE THE CASE.
DATA SHOWN IN SECTION F WAS FILLED IN BY THIS MFR. THE DEVICE EXHIBITED SIGNS OF UNUSUAL PRESSURE BEING APPLIED TO IT. THE METAL SPRING WAS BENT AND DEFORMED. THE UPPER AND LOWER JAWS WERE COMPLETELY SEPARATED WITH THE UPPER JAW BROKEN AWAY FROM THE LOWER JAW AND PIN. LENGTH AND WIDTH PARAMETERS WERE MEASURED AND FOUND TO BE IN TOLERANCE. DUE TO THE BREAKAGE, THE USUAL FUNCTION TESTS COULD NOT BE DONE. THE USER FACILITY WAS ASKED TO SEND THEIR CLIP APPLICATOR FOR INSPECTION., BUT TO DATE THEY HAVE NOT RESPONDED.
WHEN STAFF BEGAN TO RAISE THE ENTIRE BED TO PERFORM A PROCEDURE, THE HOSP BED RAISED AT THE FOOT BUT NOT AT THE HEAD OF THE BED. THE PT WAS NOT INJURED. THE BED WAS LOWERED AND LEFT IN LOW POSITION. THE DISTRIBUTOR WAS NOTIFIED AND A NEW BED WILL BE DELIVERED.
PT HAD BEEN PLACED ON INTERMITTENT SUCTION. AT SHIFT CHANGE BLOOD WAS FOUND IN THE SUCTION TUBING. THE NURSE WHO SET THE REGULATOR THOUGHT SHE HAD SET IT AT 40-60 MMHG, BUT THE SECOND SHIFT NURSE OBSERVED SETTING AT 140MMHG. THE PT WAS LAVAGED UNTIL THERE WAS NO BLOOD PRESENT. THE HOSP'S BIOMEDICAL ENGINEER CHECKED THE UNIT AND FOUND NO PROBLEMS WITH IT.
TWO FILTERS DID NOT OPEN COMPLETELY AFTER PLACEMENT. ONE FILTER WAS PLACED VIA JUGULAR AND ONE FEMORAL. THE PHYSICIAN FEELS THE PT IS PRESENTLY PROTECTED. THE DEVICES REMAIN IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO FILTER PLACEMENT WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT. HOWEVER, WITHOUT EVALUATING THE DEVICES, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTION FOR USE STATE: "AN INFERIOR VENA CAVOGRAM MUST BE PERFORMED PRIOR TO VENA CAVA FILTER INSERTION. THIS PROCEDURE DETERMINES CAVAL PATENCY AND DIAMETER AND IS USED TO EVALUATE THE INFERIOR VENA CAVA FOR THE PRESENCE OF THROMBUS AND CONGENITAL ANOMALIES. DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER. IN MOST CASES, A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE."
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH RPORT TO THE FDA.
THE UNIT RECEIVED FROM THE FIELD WAS ANALYZED IN THE LAB. THE ISU REGUALTOR SETTING PERFORMANCE WAS EVALAUTED AND THE UNIT SETTING OPERATED WITHIN SPECIFICATION. THE REPORTED PROBLEM COULD NOT BE CONFIRMED. IF THE UNIT HAD BEEN AFFECTED BY THE REPORTED PROBLEM, THE CONDITION WOULD HAVE BEEN IDENTIFIED DURING THE PRE-USE CHECKOUT. THE REPORTS FROM THE BIOMED AND THE NURSE COMBINED WTIH THE FAILURE ANALYSIS INDICATE THIS IS A CASE OF CUSTOMER EDUCATION. THE O & M MANUAL THOROUGHLY DESCRIBES THE STEPS NECESSARY TO PROPERLY CHECK THE OEPRATION AND SETTING OF THE UNIT AND THE FREQUENCY AT WHICH CHECKOUTS AND MAINTENANCE SHOULD BE CONDUCTED. THERE WAS NO REPORT OF INJURY AND A SEARCH OF THE PCRF DATABASE INDICATES THAT THIS IS AN ISOLATED INCIDENT. THIS FILE WILL BE CLOSED AND NO FURTHER ACTION WILL BE TAKEN.
WHEELCHAIR AND NEW X-TUBE. DEALER CLAIMS: BROKEN X-TUBE.
A NASAL SURGERY PROCEDURE WAS IN PROGRESS TO REMOVE POLYPS. THE METAL BOTTOM JAW OF THE ETHMOID FORCEPS BROKE OFF AND FELL INTO THE PT'S NASO-PHARYNX. IT WAS RETRIEVED WITHOUT DIFFICULTY BY THE SURGEON. NO PT INJURY OCCURRED.
DATA SHOWN IN SECTION F WAS FILLED IN BY THIS U.S. AGENT OF A FOREIGN MFR. THE LOWER JAW OF THE DEVICE WAS BROKEN OFF AT THE PIVOT PIN. THE METAL SURFACES THAT WERE EXPOSED AS A RESULT OF THE FRACTURE HAVE A CLEAN, BRIGHT AND SHINY APPEARANCE. NO EVIDENCE OF PRIOR CORROSION OR CRACKS. ON THIS BASIS, THE BREAKAGE OF THE DEVICE IS ATTRIBUTED TO EXCESSIVE PRESSURE APPLIED TO THE INSTRUMENT BY THE USER.
THE ASPIRATION LINES WERE STUCK TOGETHER.
BASED ON DAMAGE PATTERN ON THE CONNECTORS, AND A STATEMENT MADE BY THE USER FACILITY, IT APPEARS THAT THE CONNECTORS WERE SEVERELY OVER-TIGHTENED AT THE USER FACILITY. THIS MAY HAVE CONTRIBUTED TO THE DEFECT (CONNECTORS COULD NOT BE SEPARATED). THE RETURNED DEVICE WAS VISUALLY INSPECTED. THERE IS EVIDENCE OF POSSIBLE OVERHANDLING BY THE USER AS THE CONNECTORS ARE GOUGED AND CRACKED AT CONNECTOR-CONNECTOR INTERFACE. BASED ON THE ORIENTATION OF THE GOUGE MARKS IT APPEARS THAT THE ACCOUNT MAY HAVE OVER TIGHTENED THE CONNECTION RATHER THAN LOOSENING IT. THERE WAS NO EFFECT ON THE PATIENT; A SECOND BACKUP PACK WAS USED TO COMPLETE THE SURGERY.
A BALLOON RUPTURED FOLLOWING MULTIPLE INFLATIONS ABOVE ITS RATED BURST PRESSURE DURING AN ILIAC ANGIOPLASTY OF AN EXTREMELY CALCIFIED LESION VIA AN IPSILATERAL APPROACH. OTHER BALLOON CATHETERS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS REC'D, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE SHAFT UNDER THE BALLOON WAS BOWED. MICROSCOPIC EXAMINATION REVEALED AN 11MM TEAR BEGINNING 6MM FROM THE DISTAL TIP. SCRATCHES WERE NOTED ON THE BALLOON SURFACE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESURIZATION OR USE IN A CALCIFIED LESION. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH OVERPRESSURIZATION, A CORKSCREWED SHAFT UNDER THE BALLOON, AND CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES ON THE BALLOON SURFACE. CO'S FOLLOW UP ALSO INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION AS WELL AS INFLATED BEYOND ITS RATED BURST PRESSURE. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON, THESE CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY. THE RATED BURST PRESSURE SHOULD NOT BE EXCEEDED. INFLATION IN EXCESS OF RATED BURST PRESSURE MAY CAUSE THE BALLOON TO RUPTURE".
H6-86 (OTHER) MICROSCOPIC EXAMINATION. INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
INCREASING NUMBER OF INCIDENTS OF UNEXPECTED MOVEMENT OF WHEELCHAIR REQUIRING TURNING OFF POWER. POSSIBLE EMI FROM SHIP TO HARBOR RADIOS, RADIO CONTROLLED TARGETS AT NAVY BASE AND CB RADIOS FROM COMMERCIAL TRUCKS OPERATING AT THE HARBOR. HAVE HAD TO TURN OFF WHEELCHAIR MIDDLE OF CROSSWALKS AND RPTR'S AFRIAD OF CAREENING OFF SIDEWALK.
REAR S/F DAB PAINTED L QW. REAR S/F DAB PAINTED R 12. DEALER CLAIMS FRAMES BROKE.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO,DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
BACK FRAME W/BSHNG 16". DEALER CLAIMS: BROKEN OF THE RIGHT SIDE.
DEALER FAILED TO RETURN PARTS FOR EVALUATION.
FOLLOWING ANTERIOR/POSTERIOR COLPORRHAPHY, PT DEVELOPED INFECTION - TREATMENT NOT SPECIFIED. OUTCOME TO PT DOES NOT DENOTE ADVERSE EVENT. MDR REGULATIONS 7/31/96 REQUIRE REPORTING OF INCIDENT ONCE MEDICAL DEVICE FAMILY INITIALLY REPORTED ASSUMING INCIDENT COULD RECUR.
HOSPIRAL REPORTED THAT TIP OF DEVICE SHEARED OFF AT HEX DURING SURGERY. BROKEN PIECE WAS RETRIEVED.
DEVICE BROKE DURING ACL RECONSTRUCTION RESULTING IN A SURGICAL DELAY TO REMOVE BROKEN PIECE. REVIEW OF DEVICE INDICATES THAT SHAFT OF DEVICE WAS BENT INDICATING EXCESSIVE FORCE APPLIED TO DEVICE. NO PT INJURY WAS REPORTED. CO DISCLAIMER: "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW OR ITS EMPLOYEES, THAT THE  REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTTRIBUTED TO THE EVENT DESCRIVBED IN THIS REPORT."
ATTEMPTED TO PRIME TUBING WITH MEDICATION BUT UNABLE. HAD TWO FAILED TUBINGS.
PENCILS TURNS ON WHEN BUTTONS NOT PUSHED.
THE ACTUAL DEVICE WAS RETURNED AND EXAMINED. PERFORMANCE TESTING DID NOT DUPLICATE NOR VERIFY THE EVENT. HOWEVER, ONCE THE PENCIL WAS DISASSEMBLED, A CUT WIRE WAS FOUND INSIDE THE SILICONE SLEEVE. CORRECTIVE ACTION HAS BEEN TAKEN.
THE CUSTOMER REPORTED THAT THE 3100A HAS A FLUCTUATING MEAN AIRWAY PRESSURE (MAP). THE PT WAS BAGGED UNTIL PT WAS PLACED ON ANOTHER 3100A VENTILATOR. THE PT WAS NOT COMPROMISED AT ALL.
IS FREQUENCY ADDRESSED IN LABELING? NO. IF "YES" FREQUENCY GREATER THAN LABELING? IF "NO" FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "YES" SEVERITY GREATER THAN LABELED? IF "NO" SEVERITY GREATER THAN USUAL? UNK. THE CO'S SERVICE MANAGER HAS ATTEMPTED TO WORK WITH THE CUSTOMER TO DETERMINE THE SPECIFIC CAUSE OF THE MALFUNCTION AND/OR HAVE THE PT CIRCUIT RETURNED TO THE FACTORY FOR ANALYSIS, BUT HIS CALLS HAVE NOT BEEN RETURNED. THIS HAS BEEN ASSIGNED COMPLAINT # 1611A.
CLIPS LOOSE IN CLIP APPLIER; WOULD NOT HOLD ON APPLICATION. EXPIRATION DATE 8/01.
PENCIL BECAME ACTIVATED WHEN NO ONE WAS TOUCHING THE PENCIL. PENCIL WAS IMMEDIATELY UNPLUGGED FROM THE ESU.
MFG INFORMED AND CORRECTIVE ACTION HAS BEEN TAKEN. THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 10/11/96. CO WAS UNABLE TO CONFIRM OR DUPLICATE THE REPORTED EVENT. WHEN THE PENCIL WAS DISASSEMBLED A SMALL PIECE OF CUT WIRE WAS FOUND. CORRECTIVE ACTION HAS BEEN TAKEN.
THE CUSTOMER REPORTED THAT THE 3100A WAS BEING PREPARED FOR PT USE WHEN IT WOULD NOT PASS THE PT CIRCUIT CALIBRATION. THE MEAN AIRWAY PRESSURE (MAP) SHOULD BE ADJUSTED BETWEEN 39 AND 43 CMH20 BUT THIS PT CIRCUIT READ 115 CMH20. ANOTHER PT CIRCUIT WAS USED AND THE PT WAS NOT COMPROMISED AT ALL.
IS FREQUENCY ADDRESSED IN LABELING? NO. IF "YES" FREQUENCY GREATER THAN LABELING? IF "NO" FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "YES" SEVERITY GREATER THAN LABELED? IF "NO" SEVERITY GREATER THAN USUAL? UNK. THE PT CIRCUIT HAS BEEN RETURNED TO FACTORY BUT THE ANALYSIS HAS NOT BEEN COMPLETED YET. THIS HAS BEEN ASSIGNED COMPLAINT # 1613A.
REAR A/F DAB PAINTED R Q2. DEALER CLAIMS FRAME BROKE AT FRONT OF WELD WHERE BACK POST GOES INTO FRAME.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRUBUTED TO THE REPORTABLE EVENT.
REAR S/F DAB PNTD L Q2. DEALER CLAIMS FRAME BROKE AT WELD.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED THE REPORTABLE EVENT.
CO'S STANDARD PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE USER FACILITY FOR COMPLETION. IN THIS CASE, CO COULD NOT IDENTIFY THE USER FACILITY OR THE DEVICE IN QUESTION, THEREFORE, NO FURTHER INFO ABOUT THE EVENT OR DEVICE ANALYSIS IS AVAILABLE.
PUMP DELIVERED THE ENTERAL FEEDING TOO FAST. ONE PT.
STAFF MEMBERS WERE TREATING AN ELDERLY MALE PT. THE STAFF DEFIBRILLATED THE PT SEVERAL TIMES. WHILE THEY WERE MONITORING THE PT, A DOTTED LINE APPEARED ON THE UNIT'S MONITOR SCREEN. THE STAFF CHANGED THE UNIT'S CABLES, BUT THE DOTTED LINE REMAINED ON THE SCREEN. THE STAFF OBTAINED ANOTHER UNIT AND CONTINUED TO TREAT THE PT. THERE WAS NOT ADVERSE EFFECT ON PT.
OVERDOSAGE REPORTED. THE PT WAS TO RECEIVE MORPHINE ANALGESIA VIA SUBCUTANEOUS DELIVERY AT 40 MG/HR. PHARMACY WAS NOT AWARE THAT THE PUMP'S UPPER LIMIT FOR DRUG CONCENTRATION IS 10.0 MG/ML. THE 30 ML MEDICATION VIAL WAS MADE WITH A MORPHINE CONCENTRATION OF 15 MG/ML AND WAS LABELED AS SUCH. THE PHYSICIAN ORDERS WERE FOR A 40 MG/HR CONTINUOUS SQ INFUSION. THE NURSE ATTEMPTED TO SET THE DEVICE TO DELIVER AT 40 MG/HR WITH A 15.0 MG/ML CONCENTRATION. THE ACTUAL SETTINGS USED (SINCE A CONCENTRATION OF 15.0 MG/ML CANNOT BE SET) WERE NOT KNOWN TO THE RPTR. THE INFUSION REPORTEDLY CONTINUED FOR APPROX 2.5 HRS UNTIL AN EMPTY SYRINGE ALARM SOUNDED. THE INFUSION WAS DISCONTINUED AT THAT TIME. THE PT REPORTEDLY DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THE EVENT. NO MEDICAL INTERVENTION WAS REQUIRED.
EVENT OCCURRED DUE TO USER ERROR. THE DEVICE HISTORY INDICATES A CONCENTRATION OF 2.6 MG/ML WAS ENTERED ON 10/2/96 AT 11:47 PM. THE DRUG CONCENTRATION IN USE WAS ACTUALLY 15 MG/ML. FREQUENCY OF DEATH OR SERIOUS INJURY CODE 102 (OVERDELIVERY) FOR PCA IS APPROX 3.04/MILLION SETS.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED. ANALYSIS SHOWS THAT THIS CALIBRATION CODE, IF USED TO PERFORM AN ASSAY WITH TESTS STRIPS FROM ANY LOT, COULD RESULT IN HIGHER THAN EXPECTED VALUES. NO INJURIES REPORTED IN THE FIELD.
ELECTRONIC TESTING OF THE RETURNED SENSOR WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPECIFICATION.
THE TRANSFORMER IN THE REAR ARM CASTING BEGAN TO SMOKE, AFTER A PERIOD OF TIME THE TRANSFORMER DID NOT STOP SMOKING SO HE USED A FIRE EXTINGUISHER TO STOP THE SMOKING. THE MD STATED THAT THE WIRE IN THE FRIN ARM SHORTED OUT. THE LOCAL FIRE DEPT. WAS CALLED TO THE OFFICE BUT THE DR HAD ALREADY PUT THE BURNING/SMOKING TRANSFORMER OUT. THERE IS NO MENTION OF OPEN FLAMES IN THE COMPLAINT LOG.
THIS UNIT IS 8 YEARS OLD AND THE MD IS CONSIDERING REPLACING IT WITH ANOTHER UNIT. HE DOES NOT INTEND TO HAVE IT REPAIRED. THE DEALER TECHNICIAN VERIFIED THE MODE OF FAILURE. THE TRANSFORMER IN THIS UNIT FAILED DUE TO A SHORT IN THE WIRING ON THE SECONDARY SIDE OF THE DEVICE. THIS FAILURE OF THE TRANSFORMER WOULD BE EXPECTED FROM THE SHORT. THERE IS NO MENTION IN THIS REPORT OF THE REQUIRED WALL SWITCH TO QUICKLY DISCONNECT POWER. THE FAILED COMPONENT IS TOTALLY ENCLOSED IN AN ALUMINUM CASTING AND THERE WAS NO MENTION OF FLAMES.
OVERDELIVERY REPORTED BY AFFILIATE. REPORT STATES: "THE PUMP HAS DELIVERED IN FIVE HRS THE VOLUME EXPECTED FOR 24 HRS WITHOUT ANY CONSEQUENCE FOR THE PT. THE SYRINGE UTILIZED DID NOT CONFORM TO THE SUPPLIER ACCOMMODATIONS." FURTHER INFO INDICATES USE OF A BRAUN 30 ML LUER LOCK SYRINGE. THIS IS NOT THE CORRECT TYPE OF SYRINGE FOR THIS DEVICE, AND USE OF THIS SYRINGE IS NOT APPROVED. THE DEVICE SETTINGS WERE NOT AVAILABLE.
IT WAS INITIALLY RPT'D BY THE ABBOTT FRANCE AFFILIATE THAT THIS DEVICE WOULD BE AVAILABLE FOR TESTING. THEY HAVE SINCE INFORMED CO THAT THE DEVICE IS NOT BEING RETURNED FOR MFR TESTING. THE FREQUENCY OF DEATH OR SERIOUS INJURY RPT'S FOR CODE 102 (OVERDELIVERY) FOR THE LIFECARE PCA PRODUCT LINE IS 2.46/MILLION SETS.
ER STAFF MEMBERS WERE ATTEMPTING TO CARDIOVERT A PT (AGE AND GENDER UNK) AND THE UNIT DID NOT SYNCH ON THE R-WAVE. THE STAFF TURNED THE UNIT OFF AND THEN ON AGAIN, AND RESET THE UNIT TO 50J. WHEN THE STAFF ATTEMPTED TO CARDIOVERT THE PT A SECOND TIME, AN "ERROR 46" MESSAGE APPEARED ON THE UNIT'S MONITOR SCREEN. THE STAFF OBTAINED ANOTHER UNIT (MFR UNK) AND CARDIOVERTED THE PT. THERE WAS NOT ADVERSE EFFECT ON THE PT.
CANISTER SUPPORT BRACKET FELL OFF WHEN THE NURSE REACHED FOR THE PRESSURE INFUSION CUFF. THE BRACKET FELL ON THE PT AND PT RECEIVED LACERATION ON THE HEAD (THIS HAPPENED A FEW WEEKS AGO) PARTICULAR DATE UNKNOWN. DESPITE REPEATED ATTEMPTS TO OBTAIN MORE INFO, NONE WAS AVAILABLE.
ACCOUTN RECENTLY CONVERTED FROM ANOTHER CO'S PRODUCTS. USER HAS INSPECTED BRACKETS AND WILL MOVE THEM SO THERE IS MORE ROOM TO MANEUVER.
WHILE ON BYPASS PERFUSIONIST NOTICED A BLOOD TO WATER LEAK. PERFUSIONIST STOPPED THE PROCEDURE AND CHANGED OUT THE UNIT. THE CASE PROCEEDED WITH NO INCIDENT. PT IS FINE.
H-10 ALL UNK INFO REQUESTED BUT NOT REC. H-10 SECTION F PROVIDED BY MFG. H-11 DEVICE CODE 1066 NOT LABELED.
ELECTRONIC TESTING OF THE RETURNED SENSOR ((LOT# T121) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED.
WHILE IN PT USE, THE PUMP REPORTEDLY GAVE AN AUDIBLE ALARM AND STOPPED PUMPING. NO MALFUNCTION MESSAGE APPEARED ON THE DISPLAY READOUT. THE PUMP WAS INFUSING NORMAL SALINE ON LINE A AT 50 ML/HR, NEOSYNEPHRINE AT "LESS THAN 20 ML/HR" ON ONE LINE AND NITROGLYCERINE AT "LESS THAN 20 ML/HR" VIA ANOTHER LINE. THE NURSE DID NOT RECALL THE SET RATE, OR THE SPECIFIC PUMP LINES THE LATTER TWO SOLUTIONS WERE RUNNING ON. WHEN THE DEVICE WENT INTO THE ALARM CONDITION, THE PT EXPERIENCED A "TRANSITORY DROP IN BLOOD PRESSURE" FOR AN UNSPECIFIED PERIOD OF TIME. THE PUMP WAS REPLACED AND THE PT RETURNED TO HIS BASELINE STATUS WITHOUT ADVERSE SEQUELAE.
THE DEVICE WAS RECEIVED FOR TESTING AND ANALYSIS ON 10/14/96. TESTING IS NOT COMPLETE.
QR CASTER STEM W/HDWR O/S. DEALER CLAIMS: QR CASTER IS BROKEN AT THE BOTTOM OF THE CASTER HOUSING.
WAITING FOR RETURN OF DEVICE TO PERFORM EVALUATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OFTHE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED. ANALYSIS SHOWS THAT THIS CALIBRATION CODE IF USED TO PERFORM AN ASSAY WITH TEST STRIPS FROM ANY LOT, COULD RESULT IN HIGHER THAN EXPECTED VALUES. NO INJURIES REPORTED IN THE FIELD.
ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT# T371) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED.
A FACILITY REPORTED THAT A PT HAD AN EXCESS OF 4.5 KG DURING A DIALYSIS TREATMENT. THE FACILITY STATES THE RECOMMENDED PRETREATMENT TESTING WAS PERFORMED THE EVENING BEFORE. THE PT EXPERIENCED CRAMPING AND HYPOTENSION APPROX HALF WAY THROUGH THE 4 HOUR TREATMENT. THE ULTRAFILTRATION WAS TURNED OFF AND THE PT WAS TREATED WITH NORMAL SALINE, HYPERTONIC SALINE (23.4%) AND QUININE. THERE WERE NO UNUSUAL ALALRMS REPORTED DURING THE TREATMENT, BUT THE OPERATOR NOTICED THAT THE PT'S VENOUS BLOOD APPEARED DARK AND MADE THE DECISION TO DISCONTINUE THE TREATMENT. THE PT'S BLOOD WAS RETURNED. THE PT'S SYMPTOMS SUBSIDED AND THE TREATMENT WAS RESTARTED WITH A NEW DIALYZER AND BLOODLINES. THE PT'S WEIGHT AFTER THE FIRST TREATMENT INDICATED A WEIGHT LOSS OF 6.6 KG. THERE IS A DISCREPANCY OF 2.5 KG. IN THIS WEIGHT AND THE WEIGHT DOCUMENTED PRIOR TO THE SECOND TREATMENT. THE CAUSE OF THIS DISCREPANCY IS UNK. THE MACHINE WAS REMOVED FROM THE TREATMENT AREA FOR REPAIR. THE FACILITY'S TECHNICIAN DISASSEMBLED THE MACHINE BEFORE THE MANUFACTURER'S REPRESENTATIVE ARRIVED. SOME PARTS WERE MISSING THESE PARTS WERE REPLACED, THEN THE MACHINE WAS REASSEMBLED AND PROPER OPERATION WAS VEFIRIED. NO PARTS WERE AVAILABLE FOR EVALUATION. THE ACTUAL CAUSE OF THE PROBLEM CANNOT BE DETERMINED DUE TO THE CONDITION OF THE MACHINE.
QR AXLE MAG W/NUT. DEALER CLAIMS AXLE BROKE. WHEEL FELL OFF OF CHAIR.
STAKING AT HOLE NOT SUFFIENCT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNCER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OFTHAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICXE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT # S771) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED.
ACCOUNT REPORTS "5-6" INCIDENTS IN NICU IN WHICH CASSETTE ON DEVICE NOTED TO BE LEAKING. DEVICE USED FOR D10 AND TPN DELIVERY. NO PT INJURIES REPORTED FOR DEVICE ON PUMP AND PUMP ALARMED "LOW FILL". DEVICE CHANGE ONLY INTERVENTION.
SECTION F COMPLETED BY CO. NO OTHER INFO IS AVAILABLE. CUSTOMER RETURNED ONE USED SAMPLE. THE SAMPLE WAS TESTED UNDERWATER AND AIR PRESSURE WAS GRADUALLY INCREASED TO ASSESS FOR LEAKAGE. THE TOP CAP ON THE CASSETTE LEAKED AT 3 PSI OF AIR UNDERWATER DUE TO AN INSUFFICIENT SONIC SEAL.
BACK FRAME ASSM 20" RV PNTD. DEALER CLAIMS BACK BROKEN JUST BELOW BACKREST PIN.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OFTHAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OT THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT COMPLETELY DEFLATE. A SYRINGE WAS USED TO DEFLATE THE BALLOON ENOUGH FOR REMOVAL. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED RESIDUAL DRIED CONTRAST AND BLOOD PRESENT REPORTED DEFLATION DIFFICULTIES COULD NOT BE PERFORMED. THE CAUSE OF THE DEFLATION DIFFICULTY STATED IN THE COMPLAINT COULD NOT BE DETERMINED. NO MATERIAL OR MANUFACTURING DEFICIENCIES WERE NOTED.
THE DEVICE REPORTED WAS USED DURING AN UNKNOWN PROCEDURE. THE SAFETY SHIELD MALFUNCTIONED. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6;H4: INFORMATION UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION. RESULTS OF EVALUATION: CONCLUSION: BASED ON THE INFORMATION RECEIVED AND THE EXAMINATION, THE INSTRUMENT WAS RE-ARMED AND CYCLED REPEATEDLY WITHOUT INCIDENT. THE REPORTED INCIDENT OF "SAFETY SHIELD WILL NOT ARMED" COULD NOT BE REPEATED. COMMENTS: CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE PRODUCTS.
REAR S/F DAB PNTD R Q2. DEALER CLAIMS FRAME BROKEN AT WELD.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND MAY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CORRECTED DATA:D1 BIO-CONSOLE. D2 - CARDIOPULMONARY BYPASS PUMP.SPEED CONTROL. D6 - MODEL#: 540. CATALOG#: 95116. H3 - BIO-CONSOLE WAS IN ETERNAL MODE. GAIN (618) ZERO (442) PRESSURE (-030_ BATTERY FULLY CHARGED, LOW ALARM (1.62), HIGH FLOW ALARM (4.25), DISPLAY TEST FUNCTIONAL, ALL CIRCUIT BREAKERS ON, FLOW RANGE (0-51/M), AUDIBLE AC POWER ALARM (OFF), TIMER 1 AND TIMER 2 FUNCTIONAL, TOUCH PANEL DAMAGED NEAR TIMER #2, ALL MODES TESTED AND ARE FUNCTIONAL. NO ABNORMALITIES NOTED IN INTERNAL INSPECTION. BIO-CONSOLE WILL BE RETURNED TO CO FOR ADDITIONAL TESTING.
PRODUCT WAS EVALUATED ACCORDING TO CO'S SPECIFICATIONS. BALLOONS WERE INFLATED WITH AIR, NO LEAKS WERE OBSERVED. CO IS UNABLE TO CONFIRM THE REPORTED COMPLAINT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE SAFETY SHIELD RESET BUTTON DID NOT ACTIVATE. THE SURGEON COMPLETED THE OPERATION WITH ANOTHER TROCAR. THERE WAS NO CONSEQUENCE TO THE PT.
THE SET WAS BEING CHANGED FOR A CANCER PT WITH CHRONIC PAIN, WHEN THE NEEDLE WAS NOTED TO BE MISSING AFTER REMOVAL FROM THE PT. THE NEEDLE WAS NOT FOUND. THE LIGHT CONDITIONS ARE REPORTED TO BE POOR FOR THIS HOME PT. THE REPORTING PHARMACIST STATED THAT THE PT'S PAIN LEVEL DROPPED FROM 8 ON THE PAIN SCALE TO 1 DURING THERAPY. FOR THIS REASON IT IS BELIEVED THAT THE NEEDLE DID NOT BREAK WHILE IN USE WITH THIS PT. BUT MORE LIKELY BROKE SOME TIME DURING REMOVAL.
SECTION F COMPLETED BY CO PER INFO PROVIDED IN VOL MEDWATCH. SAMPLES WILL NOT BE PROVIDED FOR EVAL. COMPLAINT NUMBER 96101502.
CATHETER PLACED IN PT AFTER T.U.R.P.S. PROCEDURE. IN APPROX. 15 MINUTES, THE BALLOON BURST AND CATHETER CAME OUT. ANOTHER CATHETER HAD BEEN IN A PT FOR 24 HRS WHEN THE BALLOON BURST. BOTH WERE REPLACED.
100-WEAK POINT IN BALLOON MATERIAL FOUND IN ONE CATHETER.
DURING POWER-UP, THE CONSOLE FAILED SELF-TEST. A FOLLOWUP EVAL FOUND THAT THE FAILURE WAS DUE TO AN INSTABILITY PROBLEM WITH THE TRANSDUCER. IT WAS DETERMINED THAT MOISTURE IN THE COMPONENT CAUSED THE PROBLEM.
DURING A LAPAROSCOPIC ASSITED VAGINAL HYSTERECTOMY THE TR35W MISFIRED ON THE SECOND FIRING. STAPLES WERE PARTIALLY FIRED ON THE ONE SIDE AND NOT FIRED AT ALL ON THE OTHER SIDE OF THE CUT LINE ON THE RIGHT SIDE OF THE UTERUS. THE TISSUE WAS TRANSECTED. AN ENDOCOAGULATOR AND ER320 CLIP APPLIER WERE USED TO STOP BLEEDING. DEVICE WAS OPENED AND USED ONE TIME TO COMPLETE THE TRANSECTION ON THE RIGHT SIDE OF THE UTERUS. THE TR35W WAS RELOADED AND USED ON THE LEFT SIDE OF THE UTERUS FOR THE THIRD AND FOURTH FIRNGS WITHOUT INCIDENT. THERE WAS NO CONSEQUENCE TO THE PT.
UNAVAILABLE DEVICE WAS NOT RETURNED FOR EVALUATION.
REPORTER STATED THAT ACCOUNT REPORTED THE UNIT DID NOT MEET AN INSTITUTIONAL VERIFICATION OF DELIVERY STANDARD. A SWAP OUT WAS REQUESTED, WHICH WAS DONE. NO PT INVOLVEMENT.
SECTION F COMPLETED BY CO BASED ON INFO REC'D FROM THE REPORTER. EVAL THE UNIT WAS REC'D VERY DIRTY AND WAS TESTED AS REC'D. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
X-TUBE ASSEMBLY 20" X 18". DEALER CLAIMS X-TUBE WHILE RIDING ALONG BROKE AT CTR BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABEL EVENT.
MEDICS WERE MONITORING A 48 YEAR OLD MALE PT. AFTER APPROXIMATELY "A FEW "MINUTES THE UNIT'S MONITOR SCREEN WENT BLANK. THEY PRINTED A STRIP AND IT SHOWED THE PT TO BE IN NORMAL SINUS RHYTHM. THE MEDICS TRUNED THE UNIT OFF AND THEN ON AGAIN, BUT THE UNIT'S MONITOR SCREEN DISPLAY DID NOT REAPPEAR. THE MEDICS CONTINUED TO MONITOR THE PT'S RHYTHM BY PRINTING STRIPS. THERE WAS NO ADVERSE EFFECT ON THE PT.
THE BLUE BALL FAILED TO SEAT WHEN THE BURETTE WAS EMPTY ALLOWING AIR TO ENTER THE LINE.
CUSTOMER INDICATED SAMPLES WOULD BE RETURNED TO CO FOR EVALUATION. SAMPLES WERE NOT RECEIVED. THIS MDR IS BEING CLOSED WITHOUT THE BENEFIT OF RETURNED PRODUCT. BASED ON INFO FROM PREVIOUS SIMILAR COMPLAINTS, CO BELIEVES THAT THIS IS RELATED TO THE BLUE BALL NOT SEATING DUE TO THE SEAT BEING DEFORMED. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED VACUUM TESTING DURING ASSEMBLY TO DETECT THIS ISSUE. THIS LOT WAS MANUFACTURED PRIOR TO THIS CHANGE. CO IS UNABLE TO CONFIRM THIS ISSUE BUT IS ABLE TO DETERMINE THE PROBABLE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVALUATION. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE OPERATOR LEFT THE UNIT UNATTENDED IN THE "STERILIZE" POSITION FOR APPROX. 4 HRS AFTER THE CYCLE WAS FINISHED. UPON RETURN TO THE UNIT AND OPENING THE DOOR, THE OPERATOR STATED THAT SHE SAW A FLAME IN THE CHAMBER AND THAT THE PAPER WRAP AROUND THE LOAD HAD BEGUN TO BURN AND CHARR. THERE WERE NO INJURIES AS A RESULT OF THIS INCIDENT AND THE LIKELIHOOD OF AN INJURY IS VERY REMOTE IN THAT THE SMALL FLAME WOULD BE CONTAINED INSIDE THE UNIT. THERE WERE NO EQUIPMENT MALFUNCTIONS THAT LED TO THIS INCIDENT. AS STATED BY THE CLINIC SUPERVISOR THE CAUSE OF THIS INCIDENT WAS GROSS OPERATOR ERROR. THE UNIT WAS EVALUATED FOR PROPER OPERATION BY THE CLINIC SERVICE PERSONNEL OF THE HOSPITAL IMMEDIATELY AFTER THE INCIDENT AND WAS DECLARED TO BE FUNCTIONING PROPERLY.
H-1 THIS EVENT IS CONSIDERED REPORTABLE FROM A PERPONERANCE OF CAUTION BY CO BECAUSE THE OPERATOR SAYS THAT THEY SAW FLAME. FROM CO'S REVIEW OF THIS INCIDENT AND RELATED INVESTIGATIONS OF CO'S COMPLAINT DATABASE, IT IS VERY UNLIKELY THAT THIS TYPE OF OPERATOR ERROR WOULD CAUSE A SERIOUS INJURY. 81-THIS UNIT WAS EVALUATED AND TESTED BY THE CLINIC'S SERVICE TECHNICIAN IN THE OFFICE WHO DECLARED THAT THE DEVICE WAS OPERATING PROPERLY, THEN RESTARTED, AND PLACED THE UNIT BACK INTO SERVICE. 68-THE REPORTED INCIDENT IS DIRECTLY RELATED TO A GROSS OPERATOR ERROR WHICH ALLOWED THE STERILIZER TO REMAIN IN THE STERILIZE MODE 4 HRS AFTER THE CYCLE WAS FINISHED THUS CAUSING THE PACKS TO DEGRADE, CHARR AND THEN BURN BRIEFLY AFTER THE DOOR WAS OPENED. THE REPORTED FLAME WAS SMALL AND TOTALLY CONTAINED INSIDE THE METAL CHAMBER OF THE UNIT.
REPORTEDLY THIS SET WAS USED WITH AN INFUSOR FOR A TERMINAL PT. WHEN THE NURSE REMOVED THE BANDAGE, WETNESS WAS FOUND ALONG WITH THE REMAINING NEEDLE WHICH WAS FOUND BROKEN AT AN ANGLE. THE NEEDLE FRAGMENT WAS NOT FOUND. THE PT DID NOT REPORT ANY PAIN. THE DOCTOR WAS CONTACTED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PT WAS REPORTED TO BE IN "POOR CONDITION" AT THE TIME OF THIS EVENT AND HAS SINCE DIED. THE DEATH WAS NOT RELATED TO THIS EVENT.
EVALUATION OF RETURNED USED PRODUCT CONFIRMED A BROKEN NEEDLE AT 10X MAGNIFICATION. THE NEEDLE BROKE OFF AT THE BEND AREA. PER ENGINEER COMMENT, THIS MAY OCCUR IF THE NEEDLE IS PLACED IN AREAS OF THE BODY OUTSIDE OF LABEL COPY REFERENCE.
THE INSTRUMENT WAS USED DURING AN UNK PROCEDURE, IT WAS REPORTED THE SAFETY SHIELD DID NOT ACTIVATE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: INFO UNAVAILABLE. CORRESPONDENCE LOG: 10/9/96 1054 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/9/96 1603 DR CALLED BACK AND STATED HE IS NOT AWARE OF THE REPORTED EVENT. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT COULD NOT BE DETERMINED WHY THE INSTRUMENT'S SAFETY SHIELD REPORTEDLY "DID NOT ACTIVATE" DURING SURGERY. THE INSTRUMENT WAS RE-ARMED AND CYCLED REPEATEDLY WITHOUT INCIDENT. THE INSTRUMENT'S SAFETY SHIELD WAS EXAMINED AND TESTED AND FOUND TO FUNCTION AS DESIGNED. APPROPRIATE MFG AND ENGINEERING PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE HEPARIN 25,000 UNITS/250 ML AT 7 ML/HR. THE RN REPORTED THAT A NEW CONTAINER WAS STARTED AT APPROX 3:35PM, AND IT WAS EMPTY AT 5:45PM. THE PT RECEIVED PROTAMINE 10 MG IV AT 5:45PM AND AGAIN AT 7:40 PM. THE PT'S SERUM PTT VALUE WAS DRAWN AT 5:50 PM, APPROX 5 MINS AFTER THE PROTAMINE WAS GIVEN. THUS, PTT RESULTS ARE NOT INDICATIVE OF HEPARIN OVERDELIVERY. THE PT CHART DOES NOT INDICATE WHY THE PROTAMINE WAS REPEATED. THERE WAS NO CHANGE IN PT ASSESSMENT AND NO INDICATION OF ANY ADVERSE EFFECTS. THE PT WAS DISCHARGED HOME THE NEXT DAY.
THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE FREQUENCY OF DEATH OR SERIOUS INJURY FOR CODE 102 (OVERDELIVERY) FOR LIFECARE 5000 IS APPROXIMATELY .21/MILLION SETS.
MEDICS WERE MONITORING A PT (AGE AND GENDER UNK) DURING AN IN-HOUSE TRANSPORT AND THE UNIT LOST POWER. THE UNIT'S MONITOR SCREEN ONLY DISPLAYED A "BRIGHT GREEN DOT" IN THE LOWER LEFT HAND CORNER OF THE SCREEN. THE STAFF DISPLAY DID NOT REAPPEAR. THERE WAS NOT ADVERSE EFFECT ON THE PT.
X-TUBE ASSEMBLY 20" X 18". DEALER CLAIMS X-TUBE BROKE.
CUSTOMER INDICATED SAMPLES WOULD BE RETURNED TO CO FOR EVALUATION. SAMPLES WERE NOT RECEIVED. THIS MDR IS BEING CLOSED WITHOUT BENEFIT OF RETURNED PRODUCT. BASED ON INFO FROM PREVIOUS SIMILAR COMPLAINTS, CO BELIEVES THAT THIS IS RELATED TO THE BLUE BALL NOT SEATING DUE TO THE SEAT BEING DEFORMED. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED VACUUM TESTING DURING ASSEMBLY TO DETECT THIS ISSUE. THIS LOT WAS MANUFACTURED PRIOR TO THIS CHANGE. CO IS UNABLE TO CONFIRM TH IS ISSUE BUT IS ABLE TO DETERMINE THE PROBABLE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVALUATION. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
ACCOUNT REPORTS "AT LEAST THREE INCIDENTS" IN WHICH THE DISTAL PORTION OF THE HAND PUMP TUBING SEPARATED DURING BLOOD INFUSION. THE HAND PUMP WAS BEING SQUEEZED AT THE TIME OF THE SEPARATION. NO PT OR HCP COMPROMISE, THOUGH THERE WAS LOSS OF BLOOD DUE TO THE SEPARATION.
SECTION F COMPLETED BY CO. NO OTHER INFO IS AVAILABLE. EVAL: ONE USED Y-TYPE BLOOD SOLUTION SET WAS RETURNED FOR EVAL. IT WAS VISUALLY NOTED THAT THE TUBING WAS SEPARATED FROM THE DISTAL END OF THE PRESSURE PUMP. THE PRODUCING PLANT HAS INCORPORATED A MONITORING PROGRAM FOR SOLVENT BOND STRENGTH AFTER STERILIZATION. THE PRODUCING PLANT ALSO PERFORMS A 100% LEAK TEST ON SETS PRODUCED WITH THE HAND PUMP. AN INCREASE IN THE SOLVENT DEPTH WAS IMPLEMENTED IN JULY 1996. LASTLY, TUBING DIMENSION TOLERANCES HAVE BEEN EVALUATED TO INCREASE THE ROBUSTNESS OF THE SOLVENT BOND.
X-TUBE ASSEMBLY 19" X 16". DEALER CLAIMS TUBE BROKE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABEL EVNET.
USER REPORTS LEAKAGE OR HOLES IN TUBING. NO BLOOD EXPOSURE REPORTED.
SECTIONS A THROUGH F COMPLETED BY REPORTING SITE FOR MFR. ON 8/26/96 THE REPORTING SITE RECEIVED CONFIRMATION FROM THE MFG SITE THAT THEIR INVESTIGATION REVEALED PROBLEMS WITH LOT 6B081 AND 6B091 WHICH CONFIRMED A MFG DEFECT RESULTING IN HOLES IN THE TUBING OF THE SETS NEAR THE LUER CONNECTOR. SEVERAL CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN TO CORRECT THIS DEFECT. THE MFR'S INVESTIGATON HAS LIMITED THE DEFECT TO LOTS 6B081 AND 6B091. BOX H1 ON MEDWATCH FORM 3500A WAS MARKED AS OTHER, AS THE INCIDENTS REPORTED DID NOT INVOLVE ANY BLOOD EXPOSURE AS DEFINED BY OSHA REGULATIONS, AND MEDICAL OPINION ASCERTAINED THIS WAS NOT AN UNREASONABLE RISK TO PUBLIC HEALTH AND NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.
THE DEVICE LEAKED FROM A PORT AS MEDICATIONS WERE ADMINISTERED THROUGH ANOTHER PORT.
CUSTOMER INDICATED THAT SAMPLES WOULD BE RETURNED TO CO FOR EVAL. SAMPLES HAVE NOT YET BEEN RECEIVED. RETAINED PRODUCT SAMPLES WERE EVALUATED AND WERE FOUND TO BE ACCEPTABLE. THE LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT SAMPLES. ADD'L REPORT WILL BE PROVIDED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF CO'S EVAL.
OVERDELIVERY REPORTED BY CO AFFILIATE. REPORT INDICATES: "OVERDELIVERY - 3 TO 6 ML LESS IN SYRINGE COMPARED WITH READINGS." THE PUMP WAS USED TO INFUSE MORPHINE, THE SETTINGS WERE NOT AVAILABLE. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PT.
THE PUMP WAS TESTED AT AN INTERNATIONAL TESTING CENTER. REPORTED RESULTS INDICATE THE PROBLEM COULD NOT BE DUPLICATED AND THE PUMP TESTED WITHIN PRODUCT SPEC. THE FREQUENCY OF DEATH OR SERIOUS INJURY COMPLAINTS FOR CODE 102 (OVERDELIVERY) FOR LIFECARE PCA IS APPROXIMATELY 2.84/MILLION SETS.
X-TUBE ASSEMBLY 17" X 15". DEALER CLAIMS X-TUBE BROKE.
THE INFUSION PUMP WAS REC'D AT SVC FACILITY WITH A NOTE STATING "PUMP SAYS IT HAS INFUSED FLUID BUT HAS NOT". NO ADD'L INFO WAS REC'D. NO PT INJURY WAS REPORTED.
EVAL SUMMARY: FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPEC. THE UPSTREAM AND DOWNSTREAM OCCLUSION SENSORS WERE TESTED AND NO ABNORMALITIES WERE FOUND. THE INFUSION PUMP WAS RETURNED TO THE HOSP.
X-TUBE ASSEMBLY 17" X 17". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE INJECTION SITE FELL OF THE Y SITE DURING USE.
CUSTOMER INDICATED SAMPLES WOULD BE RETURNED TO CO FOR EVAL. SAMPLES HAVE NOT YET BEEN RECEIVED. LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVAL. ADD'L REPORT WILL BE PROVIDED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF CO'S EVAL.
STAFF MEMBERS SMELLED "SOMETHING BURNING" DURING THE NIGHT SHIFT. THE STAFF TOUCHED THE UNIT AND IT WAS  HOT AND THE UNIT'S CASE APPEARED TO BE WARPED. THE UNIT WAS NOT IN USE ON A PT AND THERE  WAS NOT ADVERSE EFFECT ON ANY PT. THE COMPLAINANT INDICATED THAT THE ALLEGED MALFUNCTION OCCURRED ON A PRIOR OCCASION. APPROX A WEEK PRIOR TO THE ALLEGED MALFUNCTION, THE FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT WAS PERFORMING PREVENTIVE MAINTENANCE ON THE UNIT. THE BIOMED STAFF SMELLED "SOMETHING BURNING" AND THE UNIT'S CASE WAS HOT TO TOUCH. THEY CHANGED THE UNIT'S BATTERY AND RETURNED THE UNIT TO SERVICE.
THE DEVICE WAS USED AN UNKNOWN PROCEDURE. THERE WAS A LEAKAGE/GASKET. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFORMATION NOT PROVIDED BY AFFILIATE. D5,6; H4,6: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THERE WAS A SAFETY SHIELD MALFUNCTION. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: BASED ON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS DETERMINED THAT THE OBTURATOR ARMED INTERMITTENTLY. THE ENDCAP WAS DISSEMBLED AND THE KNIFE COLLAR FOUND TO BE BENT WHICH MAY HAVE CAUSED THE REPORTED INCIDENT. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. COMMENTS: CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE PRODUCT.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
A NURSE WAS PERFORMING A ROUTINE SHIFT CHECK AND RECEIVED AN UNINTENDED DELIVERY OF ENERGY. THE UNIT'S JOULE SETTING WAS AT 360J BECAUSE THE STAFF HAD NOT RETURNED THE UNIT TO 0J AFTER TREATING A PT. THE NURSE INDICATED THAT SHE USED HER THUMBS TO DISCHARGE THE UNIT AND THAT SHE FELT THE ENERGY MOVE THROUGH HER LEFT HAND TO HER ARM AND UP HER LEFT SIDE. THE NURSE WAS EVALUATED AT THE FACILITY'S ER. HER HEART RATE AND BLOOD PRESSURE WERE ELEVATED FOR "AWHILE". ALL HER OTHER VITAL SIGNS WERE NORMAL. HER LEFT HAND WAS SWOLLEN AND SORE FOR TWO DAYS AND THEN THE SWELLING SUBSIDED.
THE HOSP HAS HAD REPEATED PROBLEMS WITH THE MAGNET VALVES CAUSING AGENT DELIVERY PROBLEMS AND WORKING PRESSURE FLUCTUATIONS.
68 - THE FAILURE OF THE MAGNET VALVE WAS FOUND TO BE RELATED TO THE USE OF AN INADEQUATE SPIDER PATTERN INSIDE THE MAGNET VALVE. THE SUPPLIER HAS RETURNED TO THE USE OF THE ORIGINAL STANDARD PATTERN. WE HAVE DETERMINED THAT NO FIELD UPGRADE WILL BE NECESSARY.
DURING A PTCA PROCEDURE, THE BALLOON WAS SLOW TO DEFLATE. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS CONFIRMED THE REPORTED DEFLATION DIFFICULTIES. A KINK WAS OBSERVED IN THE POLYIMIDE LUMEN OF THE SHAFT. THE KINK MAY HAVE RESTRICTED FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE SHAFT DAMAGE OR WHEN IT OCCURRED COULD NOT BE DETERMINED.
DURING A RADIAL KERATOTOMY ENHANCEMENT PROCEDURE, THE RING CAME OFF THE HANDLE OF THIS INSTRUMENT.
INSTRUMENT COULD NOT BE EVALUATED AS THE CUSTOMER DID NOT RETURN THE ENTIRE INSTRUMENT.
MEDICS WERE MONITORING A PT (AGE AND GENDER UNK) DURING AN IN-HOUSE TRANSPORT, THE UNIT LOST POWER. THE UNIT'S MONITOR SCREEN ONLY DISPLAYED A "BRIGHT GREEN DOT" IN THE LOWER LEFT HAND CORNER OF THE SCREEN. THE STAFF CHANGED THE UNIT'S BATTERY, BUT THE SCREEN DISPLAY DID NOT REAPPERAR. THERE WAS NOT ADVERSE EFFECT ON THE PT.
THE FAILURE OF THE MAGNET VALVE WAS FOUND TO BE RELATED TO THE USE OF AN INADEQUATE SPIDER PATTERN INSIDE THE MAGNET VALVE. THE SUPPLIER HAS RETURNED TO THE USE OF THE ORIGINAL STANDARD PATTERN. CO HAS DETERMINED THAT NO FIELD UPGRADE WILL BE NECESSARY.
ON 9/26/96 A PT COMPLAINED OF ABDOMINAL PAIN AND URINE GAVE A WEAK POSITIVE RESULT. THE PT'S LAST MENSTRUAL PERIOD WAS 8/25/96 AND MENSTRUATION BEGAN ON 9/25/96. THE DR DID A SCAN WHICH SHOWED AN OVARIAN CYST AND THE PT WAS OPERATED ON. SHE WAS NOT PREGNANT. THE DR THOUGHT THE PT'S PERIOD WAS NORMAL AND NOT THE RESULT OF A SPONTANEOUS ABORTION.
A60 YR OLD MALE PT EXPERIENCED A CARDIAC ARREST WHILE AT WORK. A NURSE BEGAN PERFORMING CPR ON THE PT UNTIL BLS RESPONDERS ARRIVED. THEY ATTACHD THE UNIT TO THE PT. THE UNIT'S MONITOR SCREEN BRIEFLY FUNCTIONED PROPERLY AND THEN WENT BLANK. THE BLS RESPONDERS INDICATED THAT THEY COULD HEAR BEEPS COMING FROM THE UNIT. THE MEDICS ARRIVED WITHIN MINUTES AND ATTACHED THE PT TO THEIR UNIT (MFR UNK). THE BLS RESPONDERS LATER EVALUATED THE UNIT'S PD4420(SERIAL NUMBER 2248C) CHARGER AND DETERMINED THAT THE ALLEGED MALFUNCTION WAS ATTRIBUTABLE TO THE CHARGER.
WORKING PRESSURE ON VENTILATOR WENT HIGH.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. CAUSE FOR BREAKAGE IS NOT KNOWN; HOWEVER THE DEVICE COULD HAVE BEEN CLEANED IN TOO STRONG OF A SOLUTION THAT DETERIORATED THE BRAZING.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
MEDICS PICKED UP A MALE PT (AGE UNK) WHO WAS INEBRIATED. THEY ATTACHED THE UNIT TO THE PT IN ORDER TO DOCUMENT THE PT'S ECG TRACE. THEN THE MEDICS TURNED THE UNIT ON, THE ALPHA-NUMERIC CHARACTERS WERE OUT OF FOCUS. THE UNIT'S MONITOR SCREEN WAS NOT READABLE. THE MEDICS TRANSPORTED THE PT. THE PT DID NOT REQUIRE MONITORING OR ALS INTERVENTION DURING THE TRANSPORT. THERE WAS NO ADVERSE EFFECT ON THE PT.
SECTIONS A THROUGH F COMPLETED BY REPORTING SITE FOR MFR. ON 8/26/96 THE REPORTING SITE RECEIVED CONFIRMATION FROM THE MFG SITE THAT THEIR INVESTIGATON REVEALED PROBLEMS WITH LOT 6B081 AND 6B091 WHICH CONFIRMED A MFG DEFECT RESULTING IN HOLES IN THE TUBING OF THE SETS NEAR THE LUER CONNECTOR. SEVERAL CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN TO CORRECT THIS DEFECT. THE MFR'S INVESTIGATION HAS LIMITED THE DEFECT TO LOTS 6B081 AND 6B091, BOX H1 ON MEDWATCH FORM 3500A WAS MARKED AS OTHER, AS THE INCIDENTS REPORTED DID NOT INVOLVE ANY BLOOD EXPOSURE AS DEFINED BY OSHA REGULATIONS, AND MEDICAL OPINION ASCERTAINED THIS WAS NOT AN UNREASONABLE RISK TO PUBLIC HEALTH AND NOT LIKELY TO CAUSE OR CONTRIBURTE TO A SERIOUS INJURY.
DURING A CATARACT EXTRACTION PROCEDURE, THIS BIPOLAR CORD HAD NO POWER. A BACK UP CORD WAS USED FOR THE PROCEDURE.
A PRESURGICAL PT WITH A DIAGNOSIS OF KNEE SURGERY HAD A SERUM DRAWN ON 9/24/96 AND RUN ON THE KIT FOR A POSITIVE RESULT. THE SURGERY WAS DELAYED. THE DR STATED THAT PER THE PT HISTORY, THE PT IS NOT PREGNANT. THE PT THEN HAD A PREGNANCY TEST PERFORMED ON HER OWN FOR A NEGATIVE RESULT. ON 9/30/96 THE PT HAD SERUM DRAWN. THE SERUM FROM 9/24 AND THE SERUM FROM 9/30/96 WERE BOTH TESTED WITH THE SAME LOT AND BOTH WERE WEAK POSITIVE. THE SAME SERUM SAMPLE FROM 9/30/96 WAS SENT TO ANOTHER CLINIC WHERE THE ANALYZER GAVE A NEGATIVE RESULT. THE SAMPLE WAS THEN SENT TO THE REF LAB FOR QUALITATIVE AND QUANTITATIVE TESTING. THE RESULT WAS EQUAL TO <2MLU/ML ON ANOTHER DEVICE AND NEGATIVE ON ANOTHER CO'S DEVICE.
INFO IS SOURCED FROM THE MFR. A FOLLOW-UP REPORT WILL CONTAIN ADD'L INFO WITH A FINAL EVALUATION.
OR AXLE Q/NUT. DEALER CLAIMS BEARINGS HAVE FALLEN OUT OF AXLES.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SCV FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
SECTIONS A THROUGH F COMPLETED BY REPORTING SITE FOR MFR. ON 8/26/96 THE REPORTING SITE RECEIVED CONFIRMATION FROM THE MFG SITE THAT THEIR INVESTIGATION REVEALED PROBLEMS WITH LOT 6B081 AND 6B091 WHICH CONFIRMED A MFG DEFECT RESULTING IN HOLES IN THE TUBING OF THE BLOOD COLLECTION SETS NEAR THE LUER CONNECTOR. SEVERAL CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN TO CORRECT THIS DEFECT. THE MFR'S INVESTIGATION HAS LIMITED THE DEFECT TO LOTS 6B081 AND 6B091. BOX H1 ON MEDWATCH FORM 3500A WAS MARKED AS OTHER, AS THE INCIDENTS REPORTED DID NOT INVOLVE ANY BLOOD EXPOSURE AS DEFINED BY OSHA REGULATIONS, AND MEDICAL OPINION ASCERTAINED THIS WAS NOT AN UNREASONABLE RISK TO PUBLIC HEALTH AND NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.
DURING A CATARACT EXTRACTION PROCEDURE, THE PT EXPERIENCED A SEVERE CORNEAL BURN. THIS PHACOEMULSIFICATION HANDPIECE WAS BEING USED WITH A MICROFLOW (DP8230) NEEDLE. THIS HANDPIECE AND NEEDLE HAD BEEN USED FOR THREE CASES PRIOR TO AND TWO CASES AFTER THIS EVENT. THE BURN WAS NOT NOTICED UNTIL THE HANDPIECE AND NEEDLE WERE REMOVED FROM THE EYE. THE PHYSICIAN PUT IN ONE "X" SUTURE AND ONE SINGLE SUTURE AND THERE WAS STILL SLIGHT WOUND LEAKAGE AND CORNEAL STRIATIONS (WRINKLES IN THE CORNEA CAUSED BY THE BURN). A FOLDABLE INTRAOCULAR LENS WAS IMPLANTED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTCT THE PHYSICIAN FOR ADD'L INFO CONCERNING THIS EVENT. NO ADD'L INFO HAS BEEN ABLE TO BE OBTAINED.
THIS HANDPIECE WAS RETURNED MISMARKED AND WAS DISCARDED UPON RECEIPT. NO EVAL WAS MADE.
SECTIONS A THROUGH F COMPLETED BY REPORTING SITE FOR MFR. ON 8/26/96 THE REPORTING SITE RECEIVED CONFIRMATION FROM THE MFG SITE THAT THEIR INVESTIGATION REVEALED PROBLEMS WITH LOT 6B801 AND 6B901 WHICH CONFIRMED A MFG DEFECT RESULTING IN HOLES IN THE TUBING OF THE SETS NEAR THE LUER CONNECTOR. SEVERAL CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN TO CORRECT THIS DEFECT. THE MFR'S INVESTIGATION HAS LIMITED THE DEFECT TO LOTS 6B801AND 6B901. BOX H1 ON MEDWATCH FORM 3500A WAS MARKED AS OTHER, AS THE INCIDENTS REPORTED DID NOT INVOLVE ANY BLOOD EXPOSURE AS DEFINED BY OSHA REGULATIONS, AND MEDICAL OPINION ASCERTAINED THIS WAS NOT AN UNREASONABLE RISK TO PUBLIC HEALTH AND NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.
THE 512S WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. THE 512S WAS BEING USED TO ACCESS THE ABDOMINAL CAVITY. WHEN THE SURGEON ATTEMPTED TO DEPRESS THE RED ARMING BUTTON, THE BUTTON WOULD POP BACK UP. AN OBTURATOR FROM ANOTHER 512S WAS USED TO CONTINUE THE PROCEDURE. REP REPORTS STAFF COULD NOT REMEMBER WHICH OBTURATOR WOULD NOT ARM, SO HE IS SENDING IN ALL FIVE DEVICES. THERE WAS NO PT CONSEQUENCE.
RESULTS OF EVALUATION: CONCLUSION: A,C,E) BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT COULD NOT BE DETERMINED WHY THE INSTRUMENTS REPORTEDLY "WOULD NOT ARM". THE INSTRUMENTS WERE RE-ARMED AND CYCLED REPEATEDLY WITHOUT INCIDENT. B,D) TEH INSTRUMENTS ARMED INTERMITTENTLY. B) THE ENDCAP WAS EXCESSIVELY WELDED TO THE HANDLE WHICH MAY HAVE CAUSED THE REPORTED INCIDENT. D) THE ENDCAP WAS DISASSEMBLED AND NO ANOMALIES OR DEFORMATIONS WERE OBSERVED.
MEDICS WERE MONITORING A MALE PT WHO WAS EXPERIENCING SHORTNESS OF BREATH. THE COMPLAINANT ALSO INDICATED THAT THE PT HAD C.O.P.D. AND A "BARRELING CHEST". THE MEDICS WERE USING A 3 LEAD ECG CABLE TO MONITOR THE PT. THE MONITOR FUNCTIONED PROPERLY FOR A FEW MINUTES AND THEN A "CHECK ELECTRODES" MESSAGE APPEARED ON THE UNIT'S MONITOR SCREEN AND THE ECG TRACE APPEARED AS A DOTTED LINE. THE MEDICS WERE TWO BLOCKS FROM THE HOSPITAL. THEY COMPLETED THE TRANSPORT WITH NO ADVERSE EFFECT ON THE PT.
SECTINS A THROUGH F COMPLETED BY REPORTING SITE FOR MFR. ON 8/26/96 THE REPORTING SITE RECEIVED CONFIRMATION FROM THE MFG SITE THAT THEIR INVESTIGATON REVEALED PROBLEMS WITH LOT 6B801 AND 6B091 WHICH CONFIRMED A MFG DEFECT RESULTING IN HOLES IN THE TUBING OF THE SETS NEAR THE LUER CONNECTOR. SEVERAL CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN TO CORRECT THIS DEFECT. THE MFR'S INVESTIGATION HAS LIMITED THE DEFECT TO LOTS 6B081 ZND 6B091. BOX H1 ON MEDWATCH FORM 3500A WAS MARKED AS OTHER, AS THE INCIDENTS REPORTED DID NOT INVOLVE ANY BLOOD EXPOSURE AS DEFINED BY OSHA REGULATIONS, AND MEDICAL OPINION ASCERTAINED THIS WAS NOT AN UNREASONABLE RISK TO PUBLIC HEALTH AND NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE FAILED TO CALIBRATE. ANOTHER HANDPIECE WAS USED.
BACK FRAME W/BSHNG 19" RVPNTD. DEALER CLAMIS; BROKE AT BUSHING, DEALER SAYS IT IS A STRESS POINT.
SECTIONS A THROUGH F COMPLETED BY REPORTING SITE FOR MFR. ON 8/26/96 THE REPORTING SITE RECEIVED CONFIRMATION FROM THE MFG SITE THAT THEIR INVESTIGATION REVEALED PROBLEMS WITH LOT 6N081 AND 6B091 WHICH CONFIRMED A MFG DEFECT RESULTING IN HOLES IN THE TUBING OF THE SETS NEAR THE LUER CONNECTOR. SEVERAL CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN TO CORECT THIS FEFECT. THE MFR'S INVESTIGATION HAS LIMITED THE DEFECT TO LOTS 6B081 AND 6B091. BOX H1 ON MEDWATCH FORM 3500A WAS MARKED AS OTHER, AS THE INCIDENTS REPORTED DID NOT INVOLVE ANY BLOOD EXPOSURE AS DEFINED BY OSHA REGULATIONS, AND MEDICAL OPINION ASCERTAINED THIS WAS NOT AN UNREASONABLE RISK TO PUBLIC HEALTH AND NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.
COMPLAINANT ALLEGED THAT A 48 YR OLD FEMALE PT WAS EXPERIENCING A CARDIAC ARREST. THE PT WAS DIABETIC AND HAD OTHER MEDICAL PROBLEMS. THE MEDICS ATTACHED A UNIT TO THE PT USING A MULTI-FUNCTION CABLE AND MULTI-FUNCTION ELECTRODES. THE MEDICS DETERMINED THAT THE PT'S RHYTHM WAS IN ASYSTOLE. THE UNIT'S MONITOR SCREEN DISPLAY BECAME DISTORTED. THE ALPHA-NUMERIC CHARACTERS ON THE SCREEN GREW LARGER UNTIL ONLY A WHITE DOT WAS ON THE SCREEN. THE MEDICS TURNED THE UNIT OFF AND THEN ON AGAIN. THE ALLEGED MALFUNCTION OCCURRED A SECOND TIME. THE MEDICS OBTAINED A BACK-UP AED UNIT AND TREATED THE PT. THEY ALSO ADMINISTERED MEDICATIONS AND CONVERTED THE PT'S RHYTHM. THERE WAS NO ADVERSE EFFECT ON THE PT.
STAFF MEMBERS WERE ATTEMPTING TO DEFIBRILLATE A PT (AGE AND GENDER UNK) DURING AN OPEN HEART PROCEDURE. THE STAFF INDICATED THAT THE PADDLES WOULD NOT DISCHARGE THE UNIT. THE STAFF OBTAINED ANOTHER SET OF PADDLES AND DEFIBRILLATED THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT.
USER REPORTED AN ALARM DURING USE ON A PT. ALARM (VENT FAULT) INDICATED A DEVICE MALFUNCTION PREVENTING DEVICE USE. A BACK-UP DEVICE WAS AVAILABLE, BUT THEY CHOSE TREATMENT WITH A CONVENTIONAL VENTILATOR. THERE WAS NO INJURY.
FREQUENCY AND SEVERITY OF THIS EVENT ARE NOT ADDRESSED IN THE DEVICE LABELING AND ARE NOT GREATER THAN USUAL. THE FILING OF THIS REPORT DOES NOT REFELECT A CONCLUSION BY CO THAT THE REPORT SHOWS THE DEVICE IS DEFECTIVE, NOR DOES IT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
SECTIONS A THROUGH F COMPLETED BY REPORTING SITE FOR MFR. ON 8/26/96 THE REPORTING SITE RECEIVED CONFIRMATION FROM THE MFG SITE THAT THEIR INVESTIGATION REVEALED PROBLEMS WITH LOT 6B081 AND 6B 091 WHICH CONFIRMED A MFG DEFECT RESULTING IN HOLES IN THE TUBING OF THE SETS NEAR THE LUER CONNECTOR. SEVERAL CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN TO CORRECT THIS DEFECT. THE MFR'S INVESTIGATION HAS LIMITED THE DEFECT TO LOTS 6B081 AND 6B091. BOX H1 ON MEDWATCH FORM 3500A WAS MARKED AS OTHER, AS THE INCIDENTS REPORTED DID NOT INVOLVE ANY BLOOD EXPOSURE AS DEFINED BY OSHA REGULATIONS, AND MEDICAL OPINION ASCERTAINED THIS WAS NOT AN UNREASONABLE RISK TO PUBLIC HEALTH AND NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.
MEDICS WERE TREATING A MALE PT (AGE UNK) WHO WAS EXPERIENCING A CARDIAC ARREST. THE MEDICS DEFIBRILLATED THE PT THREE TIMES (JOULE SETTING UNK). ON THE FOURTH DEFIBRILLATION ATTEMPT, THE UNIT'S MONTIOR SCREED DISPLAYED A "LOW BATTERY" MESSAGE AND THE UNIT DID NOT CHARGE. THE MEDICS CHANGED THE UNIT'S BATTERY AND DEFIBRILLATED THE PT THREE MORE TIMES. ON THE FOURTH ATTEMPT, THE UNIT'S MONITOR SCREEN WENT BLANK. THE MEDICS CHECKED THE CABLES AND WIRES AND THEY APPEARED TO BE PROPERLY CONNECTED. THEY INSERTED THE ORIGINAL BATTERY AND THE UNIT DID NOT POWER UP BUT THERE WAS A "PADDLE FAULT" MESSAGE ON THE UNIT'S SCREEN. THE PT WAS DISCONNECTED FROM THE UNIT AND CONNTECTED TO THE FACILITY'S UNIT (MFR UNK). THE CODE WAS CONTINUED AND THERE WAS NO ADVERSE EFFECT ON THE PT. AFTER THE PT WAS DISCONNECTED FROM THE UNIT, THE MEDICS TURNED THE UNIT TO MONITOR MODE. THE UNIT'S MONITOR SCREEN FUNCTIONED PROPERLY WHEN EITHER OF THE TWO BATTERIES WERE INSERTED. AN OUTSIDE BIOMEDICAL ENGINEERING FIRM EVALUATED THE UNIT AND FOUND IT TO BE FUNCTIONING PROPERLY.
DEVICE (DEFIBRILLATOR) WAS NOT RETURNED FOR EVAL. ONLY THE BATTERIES INVOLVED IN THE REPORTED EVENT WERE RETURNED FOR ANALYSIS.
THE INSTRUMENT WAS USED DURING A CORONARY ARTERY BYPASS GRAFT. THE CLIPS WERE "DEFECTIVE." UPON INVESTIGATION BY THE REP, THE ONLY THING THAT WAS DESCRIBED WAS THAT THE CLIPS WOULD NOT CLOSE COMPLETELY AROUND VESSEL. NO SURGEON NAME WAS AVAILABLE. THERE WAS NO CONSEQUENCE TO THE PT.
RECEIVED WITH A CLIP STALLED IN THE TRANSITION AREA OF THE CARTRIDGE COVER. AB)IT WAS CONCLUDED THAT REPORTED INCIDENT DURING SURGERY MAY HAVE BBEN DUE TO: A)A STALLED CLIP IN THE TRANSITION AREA OF THE CARTRIDGE COVER. THE APPLIER WAS NOTED TO HAVE COPIOUS AMOUNTS OF DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY. APPLIER WAS CYCLED AND STALLED CLIP FED INTO JAW AND THEN PARTIALLY FORMED WHEN FIRED. REMAINING 8 CLIPS FED AND FORMED PROPERLY WITHOUT INCIDENT. IT WAS CONCLUDED THAT EXCESSIVE DRIED BODY FLUIDS IN CARTRIDGE ASSEMBLY MAY HAVE CAUSED CLIP TO STALL IN TRANSITION AREA OF CARTRIDGE COVER. B)A STALLED PUSHER. APPLIER WAS RECEIVED AND IT WAS OBSERVED THAT THERE WAS NO CLIP STACK PRESSURE AND CLIPS WERE SCATTERED ALONG CLIP TRACK. APPLIER WAS CYCLED BUT CLIPS WOULD NOT FEED DUE TO A STALLED PUSHER. APPLIER WAS DISASSEMBLED AND PUSHER SPRING WAS OBSERVED TO BE ORIENTED CORRECTLY AND MOVED FREELY ALONG CLIP TRACK. NO CONCLUSION COULD BE REACHED AS TO WHAT HAD CAUSED PUSHER TO STALL. A)BRIEFLY SWISHING APPLIER WITH SALINE BETWEEN USES WILL REDUCE OCCURRENCE OF THIS INCIDENT. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO PRODUCT. B)EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
DURING A CATARACT EXTRACTION PROCEDURE, THE CORD ON THE PROXIMAL END OF THIS PHACOEMULSIFICATION HANDPIECE MELTED. ANOTHER HANDPIECE WAS USED.
ON 9/5/96, THE ACCOUNT RECEIVED A FALSE POSITIVE BHCG RESULT ON THE ANALYZER. A RESULT OF 816 MLU/ML WAS OBTAINED WHEN THE PT SAMPLE WAS FIRST RUN. A NEGATIVE RESULT WAS OBTAINED WHEN THE SAMPLE WAS RERUN FROM THE SAME LOCATION. THE PT WAS NOT KNOWN TO BE PREGNANT. THE CUSTOMER HAS STATED THAT THE FALSE POSITIVE RESULT MAY BE CARRYOVER FROM THE TECH POURING OVER SAMPLES. A SALES REP FROM THE ACCOUNT NOTED THAT THE CUSTOMER USED THE SAME PIPETTE TO PREPARE THE SAMPLE CUPS OF DIFFERENT PTS. NO REPORT OF INJURY.
INVESTIGATION SUMMARY: THE EVENT REP. IS NOT ADDRESSED IN THE DEVICE LABELING. A MALFUNCTION DID OCCUR. THIS REPORTABLE MDR EVENT WAS INVESTIGATED AS PART OF AN ONGOING STUDY OF THE AXSYM SYSTEM BY CO INTO THE CAUSATIVE REASON FOR MALFUNCTIONS. RESULTS OF THE INVESTIGATION YIELDED A NUMBER OF SYSTEM ENHANCEMENTS IMPLEMENTED ON CUSTOMER UNITS. IMPROVEMENTS INCLUDED AXSYM SYSTEM SOFTWARE VERSION 3.0 WITH ENHANCED ALGORITHM FOR FLUID DETECTION, NEW BUFFER TUBING AND SEAL FITTINGS WHICH REDUCED BUBBLES FORMING IN TUBING LINES, MODIFICATIONS TO THE LIQUID LEVEL SENSE BOARD TO DECREASE SENSITIVITY OF THE INSTRUMENT TO ELECTROSTATIC DISCHARGE, AND PACKAGING MODIFICATIONS FOR ADDED PROTECTION TO PROBES. IN ADDITION, CO HAS EMPHASIZED TO CO'S CUSTOMERS THAT CORRECT OPERATING PROCEDURES MUST BE FOLLOWED TO ENSURE OPTIMAL PERFORMANCE OF THE AXSYM SYSTEM. AREAS THAT WERE EMPHASIZED INCLUDED PROBE CRASH RECOVERY PROCEDURE, RECOMMENDED TUBE SIZES AND TYPES, OPENING REAGENT BOTTLE 4, PROPER LOADING/UNLOADING OF REAGENT PACKS, AND ENSURING PROPER SAMPLE AND REAGENT HANDLING. THIS IS THE FINAL REPORT.
BACK FRAME ASSEMBLY 18" RV PNTD. DEALER CLAIMS FRAME BROKE WHERE THE SEAT CONNECTS TO THE BACK FRAME.
THE INSTRUMENT WAS USED DURING A RIGHT BRONCHOSCOPY WITH POSSIBLE LUNG RESECTION. THE SURGEON FIRED THE APPLIER ON LUNG TISSUE. THERE WERE MULTIPLE MISFIRES WITH A COUPLE HAVING GROSS FORMATIONS. THE SURGEON STATED HE HAD IT APPROX. ON A SMALL AMOUNT OF TISSUE. SOME OF THE CLIPS FELL OUT OF THE JAWS. A MEDIUM CLIP APPLIER WAS THEN USED WITH SATISFACTORY RESULTS. THERE WAS NO CONSEQUENCE TO THE PT.
10/14/96 1025 LEFT MESSAGE AND 800# FOR MD TO CALL BACK. 10/15/96 NNCL SENT. A1,2,3,4; B6,7; D10; INFO UNAVAILABLE. D5,6;H4,6; INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
ON 9/30/96, THE ACCOUNT RECEIVED AN INCORRECT RESULT FOR THE TOXO LGG ASSAY, WHILE OPERATING THE ANALYZER. THE INITIAL RESULT OF 3.5 IU/ML WAS REPORTED TO THE DR. THIS RESULT WAS QUESTIONED AND THE SAMPLE WAS RETESTED FROM THE SAME PRIMARY TUBE. A RESULT OF 60 IU/ML WAS THEN OBTAINED AND CONFIRMED WITH REPEAT TESTING. THE PT WAS NOT KNOWN TO BE PREGNANT. HOWEVER, THE PT HAD RECENTLY GIVEN BIRTH IN 7/96 TO A CONGENITALLY DEFORMED RUBELLA BABY, WHICH SUBSEQUENTLY DIED.
X-TUBE ASSEMBLY 18" X 17". DEALER CLAIMS X TUBE BROKE.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED.
SECTIONS ATHROUGH F COMPLETED BY REPORTING SITE FOR MFR. ON 8/26/96 THE REPORTING SITE RECEIVED CONFIRMATION FROM THE MFG SITE THAT THEIR INVESTIGATION REVEALED PROBLEMS WITH LOT 6B0781 AND 6B091 WHICH CONFIRMED A MFG DEFECT RESULTING IN HOLES IN THE TUBING OFTHE SETS NEAR THE LUER CONNECTOR. SEVERAL CORRECTIVE AND PREVENTIVE ACTINS HAVE BEEN TAKEN TO CORRECT THIS DEFECT. THE MFR'S INVESTIGATION HAS LIMITED THE DEFECT TO LOTS 6B081 AND 6B091. BOX H1 ON MEDWATCH FORM 3500A WAS MARKED AS OTHER, AS THE INCIDENTS REPORTED DID NOT INVOLVE ANY BLOOD EXPOSURE AS DEFINED BY OSHA REGULATIONS, AND MEDICAL OPINION ASCERTANED THIS WAS NOT AN UNREASONABLE RISK TO PUBLIC HEALTH AND NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.
THE CUSTOMER REPORTED THAT THE 3100A DRIVER DISPLACEMENT INDICATOR BOARD WAS HARD TO ADJUST AND THE DELTA P WOULD DRIFT OUT OF SEPCIFICATION WITHIN 24 HOURS. THERE WAS NO PT INVOLVEMENT AT ALL.
IS FREQUENCY ADDRESSED IN LABELING? NO IF "YES"-FREQUENCY GREATER THAN LABELING? IF "NO"-FREQUENCY GREATER  THAN USUAL? UNK IS SEVERITY ADDRESSED IN LABELING? NO. IF "YES"-SEVERITY GREATER THAN LABELED? IF "NO"-SEVERITY GREATER THAN USUAL? UNK. THE CO'S SERVICE MGR SENT THE CUSTOMER A REPLACEMENT CIRCUIT BOARD ASSEMBLY AND A DDI PROBE ASSEMBLY WAS DEFECTIVE. IT WILL BE ANALYZED WHEN IT IS RETURNED TO THE FACTORY. THIS HAS BEEN ASSIGNED COMPLAINT 1589A.
A BLS CREW WAS MONITORING AN 84 YEAR OLD FEMALE PT WHO HAD A BRADYCARDIC RHYTHM. THE UNIT'S MONITOR SCREEN WENT BLANK WHILE IN USE ON THE PT. THE CREW CHANGED THE UNIT'S BATTERY AND THE UNIT'S SCREEN DISPLAY REAPPEARED BRIEFLY BEFORE GOING BLANK AGAIN. THEY COULD HEAR SOUNDS COMING FROM THE UNIT, BUT THE SCREEN DISPLAY REMAINED BLANK. A PARAMEDIC TEAM ARRIED AND TRANSFERRED THE PT TO THEIR UNIT. THERE WAS NO ADVERSE EFFECT ON THE PT.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS X-TUBE BROKE AT THE WELD ON RIGHT SIDE WHERE SEAL RAIL IS. GETTING OUT OF CHAIR WHEN IT SNAPPED.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THE REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABEL EVENT.
SECTIONS A THROUGH F COMPLETED BY REPORTING SITE FOR MFR. ON 8/26/96 THE REPORTING SITE RECEIVED CONFIRMATION FROM THE MFG SITE THAT THEIR INVESTIGATION REVEALED PROBLEMS WITH LOT 6B081 AND 6B091 WHICH CONFIRMED A MFG DEFECT RESULTING IN HOLES IN THE TUBING OF THE SETS NEAR THE LUER CONNECTOR. SEVERAL CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN TO CORRECT THIS DEFECT. THE MFR'S INVESTIGATON HAS LIMITED THE DEFECT TO LOTS 6B081 AND 6B091, BOX H1 ON MEDWATCH FORM 3500A WAS MARKED AS OTHER, AS THE INCIDENTS REPORTED DID NOT INVOLVE ANY BLOOD EXPOSURE AS DEFINED BY OSHA REGULATIONS, AND MEDICAL OPINION ASCERTANED THIS WAS NOT AN UNREASONABLE RISK TO PUBLIC HEALTH AND NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.
BALLOON WITH BLUE STOPCOCK (COMMON CAROTID) DEFLATES WITH DIFFICULTY.
CO CANNOT ASCERTAIN AN EXACT CAUSE FOR THE REPORTED EVENT. CO SUSPECTS USER TECHNIQUE (USE OF SYRINGE) MAY HAVE BEEN A CONTRIBUTING FACTOR.
DURING A PHACOEMULSIFICATION PROCEDURE, THIS HANDPIECE WAS LEAKING AT THE TIP. ANOTHER HANDPIECE WAS USED FOR THE PROCEDURE.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED THE INSTRUMENT WOULD NOT RELEASE THE STAPLES FOR THE GUN FROM START OF THE PROCEDURE. A NEW INSTRUMENT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: EXCESSIVE DRIED BODY FLUID AND FORMED STAPLE JAMMED IN THE CARTRIDGE NOSE. CARTRIDGE CLEARED AND FIRED REMAINING STAPLES WITHOUT INCIDENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE SCRUB NURSE ASSEMBLED THE DEVICE ON A HP051 WITH THE WRENCH. THE DH085 REPORTEDLY CONTINUED TO BE LOOSENED ON THE HP051 AND THE INSULATION WAS LOOSE. IT WAS REPORTED THE INSULATION APPEARED TO HAVE MELTED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: INFO UNAVAILABLE. DR IS OUT UNTIL 10/22/96. WILL SEND NNCL. D5,6; H4,6: INFO ANTICIPATED,,BUT UNAVAILABLE AT THIS TIME.
ON 9/30/96, THE ACCOUNT RECEIVED A FALSE NEGATIVE RESULT FOR THE RUBELLA IGG ASSAY, WHILE OPERATING THE ANALYZER. THE INITIAL RESULT OF 2.8 IU/ML WAS REPORTED TO THE DR. THIS RESULT WAS QUESTIONED AND THE SAMPLE WAS RETESTED FROM THE SAME TUBE. A RESULT OF >500 IU/ML WAS OBTAINED AND CONFIRMED WITH REPEAT RESTING. A RUBELLA IGG TEST PERFORMED IN 8/96 WAS ALSO >500 IU/ML. THE PT WAS NOT KNOWN TO BE PREGNANT. HOWEVER, THE PT HAD GIVEN BIRTH IN 7/96 TO A CONGENITALLY DEFORMED RUBELLA BABY, WHICH SUBSEQUENTLY DIED.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. WHEN THE BLADES ARE OPENED, THE BLACK SLEEVE HAS BEEN SLITTED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFO NOT SUPPLIED BY AFFILIATE. D5;6;H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY A DEVICE WAS USED AS THE OPERATIVE PORT. THE CYSTIC ARTERY AND DUCT WAS DISSECTED WITH A REUSABLE CAUTERY DEVICE. THE CYSTIC DUCT AND ARTERY WERE DIVIDED WITH A REUSABLE MONOPOLAR SCISSORS. THE GALLBLADDER WAS EXCISED OFF THE LIVER USING A DEVICE. IT WAS REPORTED THE DEVICE CAME OUT OF THE PT WHILE THE SURGEON WAS USING THE DEVICE. THE GALLBLADDER WAS REMOVED WITHOUT DIFFICULTY. AT THE END OF THE PROCEDURE WHEN THE DEVICE WAS REMOVED FROM THE PT A SMALL BURN WAS DISCOVERED ON THE SKIN. IT WAS REPORTED IT WAS IN THE SHAPE OF A "HALF MOON" AT THE TROCAR SITE.
10/4/96 1510 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/6/96 NNCL SENT, A1,2,3,4;B6,7;D5,6,10;H4; INFO UNAVAILABLE.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE, THE WHITE PLASTIC INNER SEAL HAD BECOME DISLOGED FROM THE TROCAR DURING THE CASE AND FELL INTO PT'S ABDOMEN. THE GASKET WAS RETRIEVED LAPAROSCOPICALLY AND IS BEING RETURNED WITH THE TROCAR. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6; 7; D10: ATTEMPTING TO CONTRACT SURGEON, INFO UNAVAILABLE. D6: BATCH NUMBER UNABE TO DETERMINED. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONFIRMED THAT THE INSTRUMENT'S INNER BASKET HAD "DISLODGED" DURING SURGERY MAKING THE INSTRUMENT NON-CONFORMING. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. THE ASSEMPLY LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
RN REPORTED THAT CLAMPS ON PERITONEAL DIALYSIS TUBING SETS LEAKED ON TWO OF HER PTS, NECESSITATING TREATMENT FOR PERITONITIS.
MFR FILLED OUT SECTION F. PERITONITIS IS A KNOWN COMPLICATION OF PERITONEAL DIALYSIS, REFERENCED IN LABELING. TWO CLAMPS ATTACHED TO TUBING SETS WERE RETURNED FOR INVESTIGATION. BOTH FAILED LEAK TESTS. ONE HAD BEEN DAMAGED BY USE OF PLIERS, WHICH HAD ALSO BROKEN THE CONNECTOR AND SPLIT THE TUBING. ON THE SECOND, THE CLAMP HAD BEEN INCORRECTLY PLACED ON THE TUBING, PINCHING THE TUBING AND PREVENTING COMPLETE OCCLUSION BY THE CLAMP.
CUSTOMER REPORTED THEY FELT THE OUTPUT OF THE VAPORIZER WAS HIGHER THAN EXPECTED. THERE WAS NO REPORTED PT INJURY. OHMEDA'S INVESTIGATION INTO THE REPORTED EVENT IS STILL ONGOING. A FOLLOW UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
MALFUNCTIONING PCA INFUSER RESULTING IN PT RECEIVING APPROX 600 MG OF PETHIDINE IN 7 HRS. ACTION TAKEN - CEASE PCA. PT EXPERIENCED NAUSEA AND VOMITING, TACHYCARDIA AND BODY TREMORS." HOWEVER, THE ORDER SHEET RECEIVED FROM THE USER FACILITY INDICATES: "PETHIDINE 300 MG, NORMAL SALINE DILUENT TO 30 ML, 10 MG/ML CONCENTRATION, PCA MODE, 20 MG BOLUS WITH 5 MIN LOCKOUT." THERE WAS NO LIMIT INDICATED OTHER THAN THE 5 MIN LOCKOUT. PCA DELIVERY DOCUMENTATION DOES NOT INDICATE THE NUMBER OF DELIVERIES MADE PER HR. ALL NOTATIONS FOR "MGS DELIVERED LAST HR" ARE WITHIN THE ALLOWED PARAMETERS OF THE ORDERED SETTINGS. ALSO, DOCUMENTATION INDICATES DRUG WAS IN ANOTHER CO'S SYRINGE, WHICH IS NOT APPROVED FOR USE IN THIS DEVICE. THE DEVICE REQUIRES A SPECIFIC GLASS SYRINGE DESIGNED TO FIT THE INJECTOR ASSEMBLY. NURSING DOCUMENTATION INDICATES THE PT DID FINE AFTER THE PCA WAS DISCONTINUED.
DOCUMENTATION RECEIVED FROM USER FACILITY THROUGH INTL AFFILIATE DOES NOT SUPPORT OVERDELIVERY. DOCUMENTATION INDICATES USE OF UNAPPROVED SYRINGE. DISPOSITION OF DEVICE UNKNOWN AT THIS TIME.
CUSTOMER CLAIMS THERMOMETER IS GIVING INACCURATE READINGS. THE READINGS ARE 16 DEGREE OFF.
RE H-6 (68) DEVICE HAS BEEN RETURNED TO ITS MFR FOR EVAL CORRECTIVE ACTION, AND CONCLUSION.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE D5.45NS WITH 20 MEQ OF POTASSIUM CHLORIDE AT 20 ML/HR VIA LINE A. AN IV CONTAINER WAS STARTED AT APPROX 10:30 AM. AT 7 PM, APPROX 650 ML WAS GONE FROM THE 1000 ML CONTAINER. THE EXPECTED DELIVERY WAS 170 ML. THE PT TOLERATED THE IV FLUID WELL AND NO ADVERSE EFFECTS WERE NOTED.
REPORTER STATED THAT METAL PARTICLES (FLAKES ON IRIS) WERE NOTED ONE WEEK POST OP. USES 2 INSTRUMENT TECHNIQUE BUT DOES NOT THINK THAT IS A FACTOR. NO INJURY AND NO INTERVENTION REPORTED.
H-10 NO PARTICLES WERE AVAILABLE FOR EVAL. NO PRODUCT HAD BEEN ISOLATED FOR EVAL. ORN WAS NOT AWARE OF ANY PROBLEM. PT INFO REQUESTED BUT NOT AVAILBLE. H11. SECTION F INFORMATION WAS SUPPLIED BY USER FACILITY. F10: 2203-NA ; 2204 NA.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE HEPARIN 20,000 UNITS/500CC SOLUTION AT 22 ML/HR. APPROX 1.5 HRS AFTER THE INFUSION WAS STARTED, THE PT'S HUSBAND TOLD THE NURSE THAT THE IV CONTAINER WAS EMPTLY. TWO NURSES DOUBLE-CHECKED THE SETTINGS AND VERIFIED THAT THE PUMP WAS SET AT 22 ML/HR. THE PUMP REPORTEDLY INDICATED TOTAL VOLUME DELIVERED OF 500 ML. THE HEPARIN INFISON WAS DISCONTINUED AT THAT TIME. THE FOLLOWING MORNING, WHEN THE PT PTT HAD RETURNED TO NORMAL, THE HEPARIN INFUSION WAS RESTARTED WITH A NEW PUMP. NO PT ADVERSE EFFECTS WERE REPORTED.
INFO INCLUDED IN SECTION F WAS TRANSFERRED DIRECTLY FROM A MEDWATCH FORM RECEIVED FROM THE USER FACILITY. THE DEVICE WAS RECEIVED FOR TESTING AND ANALYSIS ON 10/24/96. TESTING IS NOT COMPLETE.
THE CUSTOMER REPORTED THAT THEY REC'D A THREE STAR ALARM AND A RECORDING, BUT NO AUDIBLE ALARM.
A CO CUSTOMER ENGINEER WENT TO THE CUSTOMER'S SITE AND TESTED THE SYSTEM WITH A SIMULATOR. HE WAS NOT ABLE TO DUPLICATE THE PROBLEM. THE PRODUCT OPERATED NORMALLY. IT'S POSSIBLE THAT THE ALARM WAS MANUALLY SILENCED, BUT NOT VALIDATED. AS A PREVENTIVE MEASURE CO WILL PROVIDE ADD'L TRAINING ON ALARM VALIDATION. CO CLINICAL SPECIALIST WILL DO THE TRAINING.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE INSTRUMENTS WOULD NOT HOLD CLIPS. THERE WERE NO GOOD FINGERS. THEY WERE ALSO SPLITTING UNFORMED CLIPS. ALL CLIPS WERE RETRIEVE FROM PT. THERE WAS NO CONSEQUENCE  TO THE PT.
H6; CODE 400: YIELDED JAWS. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS OF INSTRUMENTS A & B HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENTS NON-FUNCTIONAL. INSTRUMENT A WAS ALSO FOUND TO BE EMPTY AND LOCKED OUT AND WAS FOUND TO HAVE A CRACKED LOWER SHROUD. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IT WAS CONCLUSED THAT THE INSTRUMENT C WAS RETURNED WITH NO PRELOAD OF THE JAW AGAINST THE TOP SHROUD. IT WAS CONCLUDED THAT THE TOP SHROUD TOOLING WAS WORN. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESGIN SPECIFICATION. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAM BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. A MODIFIED TOP SHROUD FROM REVISED TOOLING AND A LOWER SHROUD FROM A NEW TOOL WERE IMPLEMENTED TO MAINTAIN JAW PRELOAD AGAINST THE TOP SHROUD. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
OVERDELIVERY DUE TO PT TAMPERING REPORTED. THE PUMP WAS SET TO INFUSE MEPERIDINE 10 MG/ML, PCA DOSE OF 15 MG WITH A 15 MIN LOCKOUT. A NURSE NOTED THAT APPROX 20 TO 25 ML (200 TO 250 MG) WAS GONE FROM THE VIAL. THE MAX EXPECTED DELIVERY WAS 120 MG. THE DEVICE HISTORY REGISTERED 6 DELIVERIES FROM 11 AM TO 1:15 PM WITH MANY INJECTOR AND OCCLUSION ALARMS INDICATED. THIS SAME PT HAS A HISTORY OF SIMILAR PCA PUMP TAMPERING IN 3/96. THE PT REPORTEDLY HAS A HIGH TOLERANCE TO NARCOTICS AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THE TAMPERING/OVERDELIVERY.
RISK MGR REPORTS THAT BIOMEDICAL ENGINEERING ANALYSIS INDICATES PT TAMPERING. DAMAGE/ABUSE TO KEYPAD TOUCHSWITCH WAS NOTED. CUSTOMER CONCLUDES PT TAMPERING, DEVICE DELIVERS APPROPRIATELY.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. IT WAS REPORTED THE TROCAR SEAL FOR THE CAMERA PORT WAS LEAKING. THE TROCAR WAS REPLACED TO COMPLETE THE CASE. REP REPORTED THE OUTER SEAL HAS TWO CIRCLES CUT INTO IT. THIS OCCURRED 1 HR INTO CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,3,4; B6,7; D10: CONTACTED SURGEON INFO UNAVAILABLE. D6: L/N COULD NOT BE DETERMINED. D5; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONFIRMED THAT THE INSTRUMENT'S TORN OUTER GASKET CAUSED IT TO "LEAK" DURING SURGERY. THE PIECE WHICH HAD TORN FREE (5%) WAS NOT RECEIVED WITH THE INSTURMENT. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. THE ASSEMBLY LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE FROM KIT FTR72, FIRED THREE CLIPS SUCCESSFULLY AND THE CLIPS SPI OUT OF THE APPLIER. CLISP WERE BEING FIRED OVER OTHER CLIPS IN AN ATTEMTP TO ACHIEVE HEMOSTASIS AND MAY HAVE DAMAGED THE JAW APPERATURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4: B6,7,; D10: ATTEMPTED CONTACT WITH SURGEON, INFO UNAVAILABLE. D6: L/N COULD NOT BE DETERMINED. D5; H4 5: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. BASED UPON THE INQUIRE INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERY, MAKING THE INSTRUMENT NON-FUNCTION. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE THE TISSUE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/30/96-MEDWATCH REORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
11/22/96-SUPPLEMENT REPORT #1 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
A BALLOON RUPTURED AT EIGHT ATMOSPHERES DURNG A TIBIAL ANGIOPLASTY DILATATION OF A CALCIFIED LESION. A SECOND UNIT WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE WITH NO PT COMPLICATIONS. CO'S FOLLOW-UP INDICATED THE EXPIRATION DATE OF THIS DEVICE TO BE 11/28/95. THIS DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO ENGINEERING EVALUATION WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. CO'S FOLLOW-UP INDICATED THAT THIS DEVICE WAS USED IN A CALCIFIED LESION AND THE DEVICE WAS WELL BEYOND ITS EXPIRATION DATE. CO BELIEVES THESE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY. BALLOON RUPTURE AT LOWER PRESSURE MAY OCCUR IN STRICTURES EXHIBITING SHARP POINTS DUE TO CALCIFIED MATERIAL OR STAPLES. IF RESISTANCE IS FELT WHEN REMOVING A GUIDEWIRE THROUGH AN INTRODUCER SHEATH, STOP AND REMOVE THEM AS A COMPLETE UNIT TO PREVENT DAMAGE TO THE GUIDEWIRE, CATHETER OR VESSEL."
DENTAL ASSISTANT REPORTED THAT THREE IMPLANTS WERE OVER STRESSED AND THEN FAILED. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE MD'S OFFICE.
A BALLOON RUPTURED ON THE SECOND INFLATION AT ITS RATED BURST PRESSURE DUEING A DILATATION OF THE AORTA IN A PEDIATRIC PT. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE SHAFT UNDER THE BALLOON WAS FLATTENED. MICROSCOPIC EXAMINATION REVEALED A 2MM TEAR 4MM PROXIMAL TO THE PROXIMAL RO MARKER. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES ON THE BALLOON SURFACE. IT WAS ALSO INDICATED THIS BALLOON CATHETER WAS USED FOR AORTIC DILATATION WHICH IS NOT A RECOMMENDED USE OF THIS DEVICE. THE BALLOON ALSO RUPTURED AT ITS RATED BURST PRESSURE. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATRRIBUTE IT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: BALLOON DILATATION CATHETERS ARE RECOMMENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE ILIAC, FEMORAL AND RENAL ARTERIES AND FOR THE TREATMENT OF OBSTRUCTIVE LESIONS OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE. ANY USE FOR PROCEDURES OTHER THAN THOSE RECOMMENDED IN THESE INSTRUCTIONS IS NOT RECOMMENDED. IF LOSS OF PRESSURE WITHIN THE BALOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
H6 -86 (OTHER -MICROSCOPIC EXAMINATION). INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
THE DEVICE WAS USED DURING A LAPARAOSCPIC CHOLECYSTECTOMY. IT WAS REPORTED THE SURGEON INSERTED THE 512X WITHOUT DIFFICULTY AS A LATERAL PORT ON A MALE PT WEIGHING GREATER THAN 400 LBS. THE 512X CANNULA SHATTERED WHILE THE SURGEON WAS DISSECTING THE GALLBLADDER FROM THE LIVER. IT WAS REPORTED APPROX 3/4 OF THE CANNULA SHATTERED. THE SURGEON REPLACED THE TROCAR WITH ANOTHER 512X AND COMPLETED THE PROCEDURE. THE SURGEON THEN PERFORMED A MINI LAPAROTOMY ON THE PT IN AN ATTEMPT TO RETRIEVE THE CANNULA PIECES. IT WAS UNKNOWN WHETHER  ALL OF THE PIECES WERE RETRIEVED. THE PT REPORTEDLY WAS DOING WELL POSTOPERATIVELY. THE LOT HUMBER FOR PRODUCT WAS EITHER HD5284 OR H411E. THE 512X WAS RETAINED BY RISK MGMT. PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY. UPON REPOSITIONING CAMERA TO MEDIAL LATERAL TROCAR SITE, COULD NOT ADVANCE CAMERA. MD REMOVED THE 12MM LONG TROCAR SLEEVE TO REINSERT AND DISCOVERED THE END OF THE SLEEVE HAD BROKEN OFF. FLAT PLATE X-RAY DONE-NO FRAGENTS NOTED. AFTER GALLBLADDER REMOVED, EXPLORATORY LAPAROTOMY PERFORED. FRAGMENTS FOUND AND REMOVED. NO FURTHER FRAGMENTS PALPATED. ATTEMPTS TO RECONSTRUCT SLEEVE WITH RETRIEVED FRAGMENTS WAS UNSUCCESSFUL. 4 TROCARS USED DURING PROCEDURE, UNSURE OF WHICH SLEEVE USED." PRODUCT AVAILABLE TO REP NOW. HOSP RETURNING ALL 4 TROCARS.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED DUE TO INFECTION.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. THE DR INDICATED THAT THE PT MAY HAVE OSTEOPOROSIS. THIS IS THE SAME PT AS REPORTED IN MFR REPORT #2029012199600034.
86 = DIMENSIONAL ANALYSIS. 100 =THE RETURNED COMPONENT MET CO'S VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
WHILE ON DIALYSIS PT BECAME UNRESPONSIVE. BLOOD WAS NOTED BY CATHETER SITE (GRAFT EXTENDING FROM AXILLARY ARTERY TO AXILLARY VEIN). CATHETER WAS DISLODGED AND HEMODIALYSIS UNIT DID NOT ALARM FOR PRESSURE CHANGE. PT LOST A LARGE VOLUME OF BLOOD. MACHINE WAS EVALUATED AND IS FUNCTIONING PROPERLY. IT APPEARS THAT DUE TO SURROUNDING TISSUE AND BLANKETS AROUND CATHETER SITE, THE MACHINE CONTINUED TO SENSE SUFFICIENT BACK PRESSURE.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED DUE TO BONE LOSS. PT IS REPORTEDLY FINE.
IMPLANT WAS EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. THE DR REPORTED THAT PERIODIC CHECK-UPS REVEALED PROGRESSIVE BONE LOSS. INFECTION WAS SUSPECTED DUE TO PLAQUE ACCUMULATION AND LACK OF A PASSIVE FIT OF THE PROSTHESIS. THE IMPLANT SITE HAD BEEN GRAFTED. THIS IS THE SAME PT AS REPORTED IN MFR REPORT #2029012199600037.
PT IDENTIFIERS-31YRS, BIRTHDATE 7/24/65, MALE, PER MED WATCH RECEIVED FROM, RISK MGMT. 10/17/96 DR WAS PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY ON A VERY OBESE GENTLEMAN. SHE WAS USING THE 5/12X TROCAR. IN THE PROCESS OF USING THE TROCAR, THE INSTRUMENT THE INSTRUMENT SHATTERED. THE CASE WAS CONVERTED TO A MINI LAPAROTOMY IN AN ATTEMPT TO REMOVE ALL THE PIECES SHE FEELS THAT THERE WERE SOME LEFT BEHIND. DR INDICATED THE MATERIALS WERE COMPOSED OF POLY CARBONATE. B7;D5,6,10;F9;H4; INFO AVAILABLE. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONFIRMED THAT THE SLEEVE HAD "SHATTERED" DURING SURGERY. SOME SMALL PIECES WERE RECEIVED IN A SMALL CONTAINER, BUT NOT ALL PIECES WERE ACCOUNTED FOR. B) THE SLEEVE HAD A SLIGHTLY DAMAGED TIP-NO SHATTERING/BREAKAGE. C-D)THE INSTRUMENTS WERE RECEIVED IN GOOD CONDITION. A-D)THE OBTURATORS WERE NOT RECEIVED FOR ANALYSIS. A-C)INSTRUMENTS HAD MS512 REDUCERS ATTACHED. THE REDUCER FOR INSTRUMENT "B" WAS TORN-ALL PIECES WERE RECEIVED.
THE REPORTED MACHINE WAS THOROUGHLY CHECKED OUT BY A MEDICAL EQUIPMENT SERVICE TECH. (MES) AND NO DEFECTS WERE FOUND. THE MES CHECKED ALL OF THE PRESSURE ALARM LIMITS AND CALIBRATIONS AND THE MACHINE WAS IWTHIN MANUFACTURING SPECIFICATIONS. THE FACILITY STATED THAT THE PRESSURE DROP WAS NOT SIGNIFICAN ENOUGH TO DROP BELOW THE ALARM LIMIT TO GENERATE AN ALARM. THE FACILITY STATED THAT THE PRESSURE DID NOT DROP MORE THAN 40 MMHG AND THE ALARM LIMIT WAS SET AT +_52 MMHG. THEREFORE, NO ALARM IS EXPECTED TO OCCUR. THE FACILITY ALSO STATED THAT THE CATHETER DID NOT COMPLETERLY FALL OUT. THE CATHETER BECAME PARTIALLY DISLODGED FROM THE ARTERY BUT IT STILL HAD ENOGUH BACK PRESSURE TO MAINTAIN WITHIN THE ALARM LIMITS. THE FACILTITY STATED THAT THEY NEGLECTED THE BLOOD LEAK BECAUSE THE SURROUNDING BLANKETS SOAKED UP THE BLOOD AND IT WAS NOT NOTICEABLE FROM A DISTANCE. THIS ISSUE IS ADDRESSED BY FAR #960007. THE INFORMATION INDICATES THAT THE REPORTED MACHINE MET MANUFACTURING SPECIFICATIONS. CUSTOMER CONTACTED: YES 11/04/96, SALES/SEVICE CONTACTED BY INVESTIGATOR YES DATE 11/04/96, TRAINING REQUIRED YES.
DENTAL ASSISTANT REPORTED THAT THE RETURNED ABUTMENT LOOKS LIKE IT HAS FRACTURED.
IMPLANT WAS EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. THE DR REPORTED THAT PERIODIC CHECK-UPS REVEALED PROGRESSIVE BONE LOSS. INFECTON WAS SUSPECTED DUE TO PLAQUE ACCUMULATION AND LACK OF A PASSIVE FIT OF THE PROSTHESIS. THE IMPLANT SITE HAD BEEN GRAFTED. THIS IS THE SAME PT AS REPORTED IN MFR REPORT #20290121999600036.
IMPLANT WAS EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. THE DR INDICATED THAT THE PT MAY HAVE OSTEOPOROSIS. THIS IS THE SAME PT AS REPORTED IN MFR REPORT #2029012199600035.
86 = DIMENSIONAL ANALYSIS 100 =  VISUAL EXAMINATION SHOWED TOOL MARKS ABOUT THE COLLAR OF THE IMPLANT, POSSIBLY DUE TO THE REMOVAL PROCEDURE. THE RETURNED COMPONENT MET CO DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
THE TSW35 WAS USED. IT WORKED WELL ON THE FIRST FIRING. THE NURSE RELOADED THE INSTRUMENT WITH AN EVU35 RELOAD, NOT THE RELOAD TO BE USED WITH TSW35. THE SURGEON TRIED TO FIRE THE INSTRUMENT. WHEN IT WAS OPENED BLEEDING WAS SEEN AND THE CASE CONVERTED TO OPEN. THE PT WAS KEPT IN THE HOSP FOR AN ADD'L DAY TO MONITOR BLODD COUNT. HEMOCRIT 24. NO BLOOD PRODUCTS WERE GIVEN.
D5;H4: INFORMATION UNAVAILABLE. 11/7/96 DR. WAS PERFORMING A LAPAROSCOPIC OOPHORECTOMY AS AN OUTPATIENT PROCEDURE. HE WAS USING THE TSW35. THE FIRST FIRING WAS UNEVENTFUL, BUT ON A SUBSEQUENT FIRING THE INSTRUMENT FAILED AND IT WAS DISCOVERED THAT THE IMPROPER RELOAD HAD BEEN USED. DR. ATTRIBUTES THIS TO A FACT THE EXPERIENCED OPERATING ROOM PEOPLE WERE NOT PRESENT AT THE TIME THIS OCCURRED AND THEY WERE LESS FAMILAR WITH EQUIPMENT. HE DID NOT PERSONALLY CHECK ON THE CARTRIDGE PRIOR TO FINDING IT. THE PATIENT LOST APPROXIMATELY 1500CC OF BLOOD. TRANSFUSIONS WERE NOT REQUIRED. THE PATIENT HAS RECOVERED SATISFACTORILY. THE INSTRUMENT HAS BEEN RETURNED.
THE SURGEON STRUCK THE BROACH HANDLE LATCH TO REMOVE THE BROAAOCH FROM THE FEMUR WHEN IT "SNAPPED". HE THEN STRUCK THE PROPER IMPACTION AREA AND REMOVED THE BRAOCH. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME DUE TO THIS EVENT.
SUMMARY OF EVALUTION. THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO INSUFFICIENT STRENGTH OF THE MECHANISM TO WITHSTAND DIRECT IMPACT. ALTHOUGH NOT DESIGNED TO BE IMPACTED, THE LOCKING SHAFT MECHANISM WAS MODIFIED TO IMPROVE ITS STRENGTH AND RELIABILITY DUE TO POTENTIAL IMPACT. F1-14: HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED DUE TO INFECTION AND BONE LOSS.
THE ABOVE DESCRIBED DEVICE WAS PLACED INTO A PT FOR GASTROJEJUNOSTOMY READINGS. SOME TIME AFTER PLACEMENT, EXACT DATE UNK, THE CATHETER MIGRATED OUT OF THE PT'S STOMACH. THE PT DEVELOPED PERITONITIS AND SUBSEQUENTLY EXPIRED. ATTEMPTS TO OBTAIN ADD'L INFO HAS NOT BEEN SUCCESSFUL.
H6. - OTHER - PRODUCT WAS NOT AVAILABLE FOR EVALUATION.
DENTAL ASSISTANT REPORTED THAT TWO IMPLANTS PLACED IN BONE GRAFT (MANDIBLE RECONSTRUCTION 15 HRS AGO) FAILED.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF  THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE MD'S OFFICE.
THE DEVICE WAS USED DURING AN INGUINAL HERNIA REPAIR. IT WAS REPORTED BY THE REP. IT JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7,D10; INFO NOT PROVIDED BY AFFILIATE D5,6;H4,6 INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
THE ITEM IS BROKEN. THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR DELAY IN SURGICAL ANESTHESIA TIME DUE TO THIS EVENT.
THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO IMPROPER ASSEMBLY AND/OR IMPROPER USE OF THE DEVICE BY THE USER. THE SALES REP TO INSTRUCT THE USER TO MAKE SURE THE INNER ROD AND KNOB ASSEMBLY IS FULLY SEATED WITHIN THE END CAP PRIOR TO IMPACTING THE KNOB.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED DUE TO BONE RESORPTION.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE MD'S OFFICE.
A PT WAS TREATED ON 9/12/96 TO THE LATERAL ORBITAL CREASES, A SCAR ON THE RIGHT CHEEK AND A VERTICAL LINE ON THE RIGHT FOREHEAD. IN EARLY 10/96, EXACT DATE UNK, THE PT DEVELOPED ERYTHEMA AT ALL SITES OF TREATMENT FOLLOWED OVER THE COURSE OF THE NEXT FEW DAYS WITH CORD-LIKE SWELLING AND INDURATION. THE PT ALSO COMPLAINED OF INTERMITTENT STOMACH UPSET (ONSET UNK) WHICH THE PHYSICIAN DID NOT BELIEVE WAS RELATED TO COLLAGEN BUT WAS ATTRIBUTED TO STRESS. THE PHYSICIAN DIAGNOSED THE ERYTHEMA, SWELLING AND INDURATION AT THE TREATMENT SITES AS A HYPERSENSITIVITY AND PRESCRIBED ELOCON CREAM AND AN ORAL ANTIHISTAMINE AND ASKED THE PT TO DISCONTINUE ASPIRIN.
ON 2 DECEMBER 1997, FOLLOW UP WAS REC'D FROM THE PHYSICIAN. THE PT WAS LAST SEEN ON 06 NOVEMBER 1997. THE SYMPTOMS RESOLVED IN APPROX AUGUST OR SEPTEMBER 1997.
THE PT HAD A FILTER PLACED APPROX. ONE YR AGO. THE PT WAS PRESENTED TO THE HOSPITAL WITH THE FILTER HAVING MIGRATED INTO THE RIGHT VENTRICLE. CO HAS BEEN UNABLE TO OBTAIN ANY FURTHER INFO REGARDING THIS EVENT.
A. 1,2,3,4) INFO WAS NOT AVAILABLE. B. OTHER-INFO WAS NOT SUPPLIED AS TO THE OUTCOME OF THIS ADVERSE EVENT. D. 5)UNABLE TO OBTAIN WITHOUT LOT# INFO. 6) LOT#-INFO WAS NOT AVAILABLE.8) INFO WAS NOT AVAILABLE. E. NO INFO AVAILABLE CONCERNING INDIVIDUAL OR HOSPITAL REPORTING EVENT. F.3,4,5) NO INFO AVAILABLE CONCERNING INDIVIDUAL OR HOSPITAL REPORTING EVENT. 9) UNABLE TO DETERMINE WITHOUT LOT # INFO. H. 4) UNABLE TO DETERMINE WITHOUT LOT # INFO. 6) METHOD DEVICE WAS NOT RETURNED FOR EVALUATION.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. LABORATORY EXAMINATION OF THE RETURNED ITEM REVEALED NO DEFECT. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. TESTING FOR OCCULT BLOOD WITHIN THE BALLOON WAS NEGATIVE. PROBABLE CAUSE OF DIFFICULTY: BASED ON THE EVENT DESCRIPTION AND PHYSICIAL EVIDENCE, THERE WAS NO LEAK IN THE IAB. IT IS PROBABLE THAT DURING INSERTION BLOOD FLOWED BETWEEN THE FOLDS OF THE MEMBRANE AND EXITED NEAR THE CATHETER-MEMBRANE JUNCTION, LEADING TO THE PERCEPTION THAT THE BALLOON HAD LEAKED. DATASCOPE HAS INCORPORATED THIS CHANNELING PHENONOMEN IN ITS INSTRUCTIONS FOR USE FOR ALL STAT IABS.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 10/11/96 AND 10/31/96. PATIENT'S CURRENT STATUS: UNK-RPT'D 10/11, 10/31/96.
THE DEVICE WAS USED DURING A LAVH EZ35W. BLACK HANDLE MAY HAVE BEEN SQUEEZED FIRST, RESULTING IN A LOCKOUT. THE DEVICE WAS OPENED AND REMOVED FROM THE STERILE FIELD. A SECOND EZ35W WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
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
DENTAL ASSISTANT REPORTED TAHT AN IMPLANT FAILED DUE TO BONE RESORPTION. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-00214.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH TEH COMPONENT ITSELF. CO FOUND THE IMPLANT TO ACTUALLY BE A (0801) 8MM IMPLANT INSTEAD OF THE (0802) 10MM IMPLANT ORIGINALLY REPORTED. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE MD'S OFFICE.
THE HANDLE IS CRACKED ON THE GRIP IMPACTOR. THIS DID EVENT NOT OCCUR DURING A SURGICAL PROCEDURE. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE ROOT CAUSE OF THE HANDLE BREAKAGE IS ATTRIBUTED TO THE LONG TERM EFFECTS OF AUTOCLAVING AND IMPACTING. CORRECTIVE ACTION WAS IMPLEMENTED TO IMPROVE THE RELIABILITY OF THE PLASTIC HANDLE.
ON 10/17/96, THE PT CONTACTED A MFR NURSE AND REPORTED THAT THE DEVICE WAS REFILLED FOR THE FIRST TIME IN THIS STATE. IT WAS ADDITIONALLY STATED THAT THE FACILITY NURSE TURNED THE EMPTY BARREL SYRINGE UPSIDE DOWN AND LOST THE RESIDUAL, AS A RESULT THE FLOW RATE COULD NOT BE CALCULATED. THE PT DID NOT THINK THAT A SAFETY CHECK FOR RETURN VOLUME WAS PERFORMED AT 5 CC'S. THE PT REPORTED THAT IT SEEMED LIKE THE FLUID WAS JUST PUSHED IN. THE DEVICE SIDEPORT WAS REPORTEDLY ACCESSED WITH A NEEDLE ONLY," A LOT OF BLOOD FROM THE ARTERY CAME OUT". TUBING WAS PUT ON THE NEEDLE TO DRAW THE BLOOD, THEN MITOMYCIN WOULDN'T FLOW SO IT WAS GIVEN WITH A LARGER SYRINGE, THEN HEPARINIZED. THE PT INQUIRED WHETHER THIS IS THE CORRECT PROCEDURE AND WHETHER HE SHOULD RETURN TO HIS PREVIOUS ONCOLOGIST IN ANOTHER STATE FOR DEVICE REFILLS. THE MFR NURSE RELAYED THE IMPORTANCE OF POSITIVE PRESSURE WHEN ACCESSING THE DEVICE SIDEPORT. IN ADDITION, THE MFR NURSE OFFERED  TO CONTACT THE FACILITY AND OFFER AN IN-SERVICE FOR THE NURSES. THE PT'S PHARMACIST WAS CONTACTED PER THE PT'S REQUEST AND THE ABOVE INFO WAS RELAYED. THE PHARMACIST STATED THAT HE WOULD LOOK INTO SCHEDULING AN IN-SERVICE.
A DEVICE IN-SERVICE TRAINING WAS PROVIDED ON 10/30/96. THE DEVICE WAS ACCESSED ON 10/30/96 AND THE RETURN VOLUME=23ML, FLOWRATE=1.93ML/DAY. THE DEVICE WA REFILLED WITH HEPARINIZED SALINE (50,000 U/50ML) AND THE DEVICE SIDEPORT FLUSHED EASILY WITH 5ML HEPARINIZED SALINE (1000/ML). THE DEVICE SIDEPORT WAS PATENT AND NO PROBLEMS WERE NOTED. THE DEVICE IS FUNCTIONING AS INTENDED. BASED ON THE INFO AVAILABLE THIS EVENT APPEARS TO BE PROCEDURAL RELATED AND NOT DUE TO THE DEVICE OR A DEVICE MALFUNCTION. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
PT RECEIVED HER FIRST TREATMENT IN APPROX 7/96 (EXACT DATE REFUSED) TO RHYTIDS ABOVE THE UPPER LIP AND THE LEFT CHEEK. ON APPROX 10/24/96, THE PT DEVELOPED HYPOPIGMENTED AREAS ON HER BODY (LOCATIONS NOT RECALLED) AND SWELLING OF THE ENTIRE UPPER LIP WHICH THE PHYSICIAN DESCRIBED AS BEING "FIVE TIMES THE NORMA SIZE." THE PHYSICIAN BELIEVED THE SWELLING WAS RELATED TO THE COLLAGEN TREATMENT BUT WAS NOT SURE IF IT WAS RELATED TO THE INJECTION PROCEDURE OR TO A HYPERSENSITIVITY. THE PHYSICIAN DIAGNOSED THE HYPOPIGMENTED AREAS AS VITILIGO AND BELIEVED THAT THE VITILIGO WAS RELATED TO THE COLLAGEN TREATMENT. INTRAMUSCULAR KENALOG WAS PRESCRIBED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC SPLENECTOMY. EZ35W BLACK TRIGGER WAS PARTIALLY SQUEEZED RESULTING IN A PARTIAL FIRING OF THE CARTRIDGE. WHEN THE SURGEON CLOSED THE WHITE HANDLE OF THE DEVICE. THE DEVICE LOCKED OUT. CONSIDERABLE EFFORT WAS NEEDED TO REMOVE THE DEVICE FROM THE SPLENIC HILUM. THE DEVICE WAS RELOADED AND FIRED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
10/10/96 1147 MESSAGE AND 800# LEFT ON PHYSICIAN'S PM FOR FOLLOW UP. 10/11/96 1020 NNCL SENT, A1,2,3,4; B6,7; D5,6,10;H4 INFO UNAVAILABLE.
METHOD (86): PART WILL NOT BE RETURNED, IT WAS LOST BY DR'S OFFICE. LOT NUMBER NOT AVAILABLE FROM DR'S OFFICE.
SURGEON IMPLANTED ABSORBABLE BONE PINS DURING FINGER ARTHROPLASTY AND ALSO IMPLANTED APPLICATOR TUBES WHICH ARE NOT INTENDED FOR IMPLANTATION.
USER FACILITY CONTACTED CO BY TELEPHONE ON 10/18/96 TO REQUEST INFO ON EFFECTS/CONSEQUENCES RESULTING FROM IMPLANTING BONE PIN APPLICATOR TUBES WHICH ARE NOT INTENDED FOR IMPLANTATION. THE SURGEON REPORTED BEING ADVISED BY OPERATING ROOM STAFF THAT THE DEVICES WERE ABSORBABLE AND HE ASSUMED THE PIN CASINGS TO BE ABSORBABLE/IMPLANTABLE. INSTRUCTIONS PROVIDED WITHIN PACKAGE INSERT ACCOMPANYING THE BONE PINS WERE NOT FOLLOWED. USER FACILITY WAS ADVISED OF CONCERNS INVOLVING SHORT AND LONG TERM STRUCTURAL EFFECTS AND POSSIBLE CORROSIVE ACTION FROM LONG TERM IMPLANTATION. CO HAS RECOMMENDED REMOVAL OF THE APPLICATOR TUBES. THE USER FACILITY HAS NOT INDICATED WHEN OR IF REMOVAL WILL TAKE PLACE. NOTE: THE INFO IN SECTION F IS BEING SUPPLIED BY THE MFR AND THE USER FACILITY. NO MEDWATCH FORM HAS BEEN RECEIVED FROM THE USER FACILITY.
THE TIBIAL INSERT WOULD SNAP INTO THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
CORRECTED DATA: H4: MANUFACTURE DATE: 9/13/96. SUMMARY OF EVALUATION: THE TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE INSERT IN THE AS-RECEIVED CONDITION WAS THEN ASSEMBLED TO THREE BASEPLATES WITH THE RESULTS OF CRISP SNAP ACTION AND FULL, TIGHT SEATING USING ONLY TWO THUMBS PRESSURE IN ALL TESTS. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT, AS WELL AS FOR THE REPORTED BASEPLATE, FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE EXAMINATION RESULTS, ALTHOUGH NOT CONCLUSIVE IN THE ABSENCE OF THE EVENT BASEPLATE, SUGGESTS THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE TECHNIQUE.
IMPLANT PLACED IN SITE #11 (CLASS II BONE) IN CONJUNCTION WITH RESORBABLE MEMBRANE. CLINICIAN NOTED THAT THIS WAS THE SECOND IMPLANT IN THIS SITE. CLINICIAN ATTRIBUTES FAILURE TO PT SMOKING (VERY HEAVY SMOKER), POOR HYGIENE, AND LOTS OF STRESS IN HER LIFE.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED.
THE AL326 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. WHEN SURGEON PULLED HANDLE OF THE DEVICE FOR THE FIRST TIME, THE CLIP FORMED OVER THE CYSTIC DUCT HALF WAY AND WOULD NOT RELEASE FROM THE APPLIER. THE SECOND FIRING WAS SIMILAR, BUT TWO CLIPS WERE ENGAGED. ER320 WAS THEN OPENED TO COMPLETE THE CASE.
10/04/96 1430 MESSAGE AND 800 LEFT FOR MD CALL BACK. 10/06/96 NNCL SENT. 10/11/96 1540 DR. CALLED BACK AND STATED THE FIRST CLIP FIRED WITHOUT DIFFICULTY. THE NEXT TWO FIRED OUT OF THE INSTRUMENT BUT DID NOT ATTACH AT ALL TO THE STRUCTURE AND FELL INTO THE PT. THEY WERE RETRIEVED. CASE COMPLETED WITH ANOTHER INSTRUMENT. DR. DENIED ANY TACTILE OR AUDIBLE FEEDBACK. A1,2,3,4; B6,7,D5,6,10;H4; INFO AVAILABLE. BASED UPON THE INQUIRY INFO REC'D. THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICIAL CONDITION. THE INSTRUMENT WAS CYCLED AND FED THE CLIPS AS DESIGNED. THE CLIP FORM WAS WITHIN DESIGN SPEC. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED PROPERLY AND THAT THE CLIP FORM IS WITHIN DESIGN SPEC.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY UNFOLDED. NO SHEATH WAS NOTED TO BE PRESENT ON THE CATHETER TUBIGN. IN ADDITION, THE ORIGINAL SHEATH USED DURING THE BALLOON INSERTION WAS NOT RETURNED FOR EVALUATION WITH THE BALLOON. THE CATHETER O.D. WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. IT WAS NOT POSSIBLE TO INSERT THE RETURNED IAB THROUGH A LABORATORY 10 FRENCH, 11 INCH SHEATH DUE TO THE CONDITION OF THE RETURNED IAB MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: BASED ON THE EXAMINATION OF THE RETURNED PRODUCT, IT WAS NOT POSSIBLE TO VERIFY THE ENCOUNTERED DIFFICULTY IN THE LAB DUE TO THE CONDITION OF THE RETURNED IAB MEMBRANE. HAVING THE OPPORTUNITY TO EXAMINE THE FOLDED MEMBRANE AND ORIGINAL SHEATH MAY HAVE PROVIDED SOME ADDITIONAL INFO INTO THE ENCOUNTERED PROBLEM. IN ADDITION, IT WAS NOT REPORTED IF A SECOND IAB WAS INSERTED INTO THE PATIENT VIA THE SHEATH FROM THE FIRST BALLOON. THIS INFO COULD HAVE BEEN HELPFUL IN DETERMINING WHETHER OR NOT THE PROBLEM WAS IAB OR SHEATH RELATED. IN GENERAL, DIFFICULTY ADVANCING THE IAB INTO THE SHEATH OR INTO THE PATIENT MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: THE USER MAY AHVE NOT DRAWN A SUFFICIENT VACUUM ON THE BALLOON DURING ITS REMOVAL FROM THE BLISTER TRAY. IF DRAWN, A VACUUM MAY HAVE NOT BEEN MAINTAINED THROUGHOUT THE INSERTION PROCEDURE. DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH OR IAB MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. THE PATIENT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO THE SHEATH. DURING IAB INSERTION, THE BALLOON TIP MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY AS IT EXITED THE END OF THE SHEATH.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 9/30/96. PATIENT'S CURRENT STATUS: UNK - REPORTED 9/30/96.
LOSS OF INTEGRATION OF ENDOSSEOUS DENTAL IMPLANT. REMOVED IMPLANT WAS AN IMMEDIATE IMPLANT (FRACTURED BICUSPID) ON PALATAL ROOT. EARLY IMPLANT FAILURE; IMPLANT NOT YET LOADED.
THE OPERATING TEAM HAD TO MANUALLY EMPTY THE CASSETTE AND WHEN THEY TRIED TO CONTINUE WITH THE PROCEDURE, THE CASSETTE WOULD NOT WORK. THEY SWITCHED TO A CANNULA (A MANUAL TECHNIQUE). FOLLOW-UP REPORT ON 10/4/96 STATED: HOSP ADVISED THAT BECAUSE OF THE INCIDENT, THE PT HAS A CLOUDY CORNEA AND IS BEING CONSIDERED FOR A TRANSPLANT.
H-10: A CO SERVICE REP CHECKED THE SYSTEM FOLLOWING THE INITIAL REPORT AND FOUND IT TO MEET ITS PERFORMANCE SPECIFICATIONS. THERE WERE NO CONSUMABLES SAVED. THE INTERMITTENT CASSETTE PROBLEM HAD BEEN IDENTIFIED AT ALCON PREVIOUSLY BUT IT DID NOT CONSTITUTE A PRODUCT MFG PRIOR TO THE PRODUCT CHANGE. STOCK PRODUCTION, AND ALL FUTURE SHIPMENTS WILL BE OF THE MODIFIED CASSETTE. AS REPORTED, THE CHANGE-OUT OF THE CASSETTE ALONE WOULD NOT CAUSE CORNEAL EDEMA. SEVERAL OTHER FACTORS COULD INFLUENCE OUTCOME. H-11: ALL MISSING INFO HAS BEEN REQUESTED FROM USER FACILITY, BUT HAS NOT BEEN RECEIVED TO DATE. THIS REPORT WAS MAILED IN TO FDA ON: 11/4/96 DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIRMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
REAMER UNWOUND WHEN REVISING AND BROKE OFF IN FEMORAL CANAL. ADD'L BONE CUTS WERE REQUIRED TO DISENGAGE BROKEN PORTION OF REAMER FROM THE CANAL AND SURGICAL TIME WAS EXTENDED.
VISUAL EXAMINATION OF THE RETURNED REAMER AND INFO PROVIDED BY THE SALES AGENT PRESENT DURING SURGERY DETERMINED REAMER WAS NOT USED IN CONJUNCTION WITH GUIDEWIRE AS REQUIRED AND DESCRIBED IN THE SURGICAL TECHNIQUE. AS A RESULT, THE REAMER UNWOUND WHEN PUT IN REVERSE AND BROKE OFF IN FEMORAL CANAL. NOTE: THE INFO IN SECTION F IS BEING SUPPLIED BY THE MFR AND NOT THE USER FACILITY. NO MEDWATCH FORM HAS BEEN RECEIVED BY THE USER FACILITY.
THE TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE ANTERIOR LOCKING TAB EXHIBITS SIGNIFICANT DISTORTION DUE TO HAVING BEEN CRUSHED BY THE LOCKING POST OF THE BASEPLATE DURING THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. THIS CONDITION SUGGESTS THAT THE INSERT WAS NOT POSITIONED FULLY POSTERIOR WHEN IT WAS IMPACTED. THE INSERT AS RECEIVED WAS THEN ASSEMBLED TO A BASEPLATE WITH THE RESULTS OF POOR SNAP ACTION AND INSECURE LOCKING. THE LOCKING TAB WAS THEN BENT TO NEAR ITS ORIGINAL DESIGN POSITION AND THE TEST REPEATED. RESULTS WERE THEN FULL, TIGHT SEATING USING ONLY TWO-THUMBS PRESSURE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE.
DURING A LAPAROSCOPIC BANDING PROCEDURE, THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE THE TISSUE. THE SURGEON USED APPLIED ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DENTAL ASSISTANT REPORTED TAHT AN IMPLANT FAILED AFTER YEARS DUE TO INFECTION AND BONE LOSS.
AFTER A DIRECTIONAL CORONARY ARTHRECTOMY PROCEDURE IT WAS NOTED THAT A DISSECTION HAD OCCURRED IN THE CORONARY ARTERY. A STENT WAS REQUIRED TO TREAT THE DISSECTION. NO PT SEQUELA REPORTEDLY OCCURRED.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. TYPE OF EVENT ADDRESSED IN LABELING?(SEC F10) 1701 FOR CODE 1333. CODE 2203: NO REPORT OF DEVICE FAILURE. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSP OR DISTRIBUTOR.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. ON THE SECOND FIRE THE INSTRUMENT BROKE. NEW INSTRUMENT WAS OPENED TO FINISH THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
THE ACETABULAR INSERT WOULD NOT LOCK INTO THE SHELL. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT REPORTED AT THIS TIME.
CORRECTED DATA: H4: MFG. DATE = 1/24/95.SUMMARY OF EVALUATION: AS RECEIVED, THE RETURNED PCA ACETABULAR INSERT IS OBSERVED TO BE IN GOOD CONDITION EXCEPT FOR IMPACTION MARKS/INDENTS NEXT TO THE INSERT HOLE THAT MATES WITH THE PIN ON THE IMPACTOR ALIGNMENT DISC AND THE RIM ON THE INFERIOR SIDE OF THE INSER IS BENT. DUE TO SUBSEQUENT MANUFACTURING OPERATIONS, THE RELEVANT INSERT DIMENTIONS CANNOT BE ASCERTAINED. THE RETURNED INSERT WAS FUNCTIONALLY TESTED WITH ACCEPTABLE PCA ACETABULAR OUTER SHELLS. THIS TEST REVEALED THE RETURNED INSERT SEATED AND LOCKED TIGHTLY IN BOTH SHELLS. THE RETURNED INSERT FUNCTIONS BY DESIGN. THE DEVICE HISTORY RECORD FOR THE LOT CODE OF THE RETURNED INSERT WAS REVIEWED AND NOT DISCREPANCIES WERE OBSERVED. THE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS NOT ASSOCIATED WITH THE DEVICE.
DURING A LAPAROSCOPIC BANDING PROCEDURE, THE SAFETY SHIELD WOUND NOT RETRACT TO PENETRATE THE TISSUE. THE SURGEON USED APPLIED ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/30/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
DURING A LAPAROSCOPIC BANDING PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE THE TISSUE. THE SURGEON USED APPLIED ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PT MAILED IMPLANT TO DR, PT INITIALLY SEEN ON 5/20/92, IMPLANTS PLACED 5/25/92, RESTORED 9/9/92, 6/14/95 INFLAMMATION RX FLAGYL, 9/14/95 BONE LOSS NOTED, 9/23/90 IMPLANT FAILED.
DEVICE WAS IMPLANTED ON 9/11/96. REVISION SURGERY WAS PERFORMED ON 9/26/96, DUE TO DISLOCATION.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS TYPE OF EVENT IS NOT OCCURRING  AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION  WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO DRAW A CONCLUSION AS TO THE CAUSE OF THE EVENT. A FAX WAS SENT TO THE USER FACILITY ON 10/21/96. CO, DID NOT RECEIVE A MEDWATCH REPORT FORM THE USER FACILITY.
DURING A LAPAROSCOPIC BANDING PROCEDURE, THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE THE TISSUE. THE SURGEON USED APPLIED ANOTHER  INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A THORACOSCOPY. FIRING, IMPOSSIBLE TO OPEN THE JAW. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: INFO NOT SUPPLIED BY AFFILIATE. D5,6; H4,6: INFO ANTICIPATED, BUT AVAILABLE AT THIS TIME.
THERE WAS MOTION OF THE TIBIAL INSERT IN THE BASEPLATE. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE ANTERIOR LOCKING TAB EXHIBITS NO DISTORTION AS A RESULT OF THE INTRA-OPERATIVE ASSEMBLY, CONTRARY TO EXPECTATIONS. THE INSERT IN THE AS-RECEIVED CONDITION WAS THEN ASSEMBLED TO FOUR BASEPLATES WITH THE RESULTS OF CRIPS SNAP ACTION AND FULL, TIGHT SEATING USING ONLY TWO-THUMBS PRESSURE IN ALL TESTS. THE REPORTED "GROSS MOTION" WAS NOT DUPLICATED AS NO MOVEMENT WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MFR. THE EXAMINATION RESULTS, ALTHOUGH NOT CONCLUSIVE IN THE ABSENCE OF THE EVENT BASEPLATE, SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE TECHNIQUE.
PER THE INFO PROVIDED TO CO THROUGH MEANS OF THE PHYSICIAN/SURGEON'S OPERATIVE REPORT, IT STATED "PREOPERATIVE DIAGNOSIS: HYDROCELE. POSTOPERATIVE DIAGNOSIS: INFECTED PENILE IMPLANT". IT WAS THEREFORE REMOVED AS IT WAS "INFECTED", ADD'L, THE OPERATIVE REPORTED STATED "THE PT HAS PROGRESSIVE ENLARGEMENT AND TENDERNESS IN THE SCROTUM AND THE PUMP IS FIXED, THIS IS SUSPICIOUS FOR INFECTION. EXPLORATION WAS REQUIRED. FINDING OF PURULENT EXUDATE AROUND THE PUMP NECESSISTATED REMOVAL OF ALL THE COMPONENTS".
IN THE RECEIVED INFO THE PHYSICIAN STATED THAT THE PT PRESENTED WITH "PROGRESSIVE ENLARGEMENT AND TENDERNESS IN THE SCROTUM" AND THAT THE "PUMP IS FIXED" IN POSITION. THE PHYSICIAN STATED THAT UPON OPENING THE POCKET AROUND THE PUMP "THICK INFLAMMATORY ESCHAR" WAS OBSERVED, AND THAT "PURUIENT EXUDATE" WAS NOTED WITHIN. THE ENTIRE IMPLANT WAS REMOVED. CULTURES OF THE EXUDATE SHOWED THE PRESENCE OF STAPH EPI ORGANISMS. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION. QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE INFECTION REPORT. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE.
DR REPORTED TAHT AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON USED A NEW INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. ATW35 WAS FIRED ON THE IP LIGAMENT. THE PT SIDE OF THE STAPLE LINE WAS HALF FORMED. THE OTHER HALF OF THE STAPLES WERE ELONGATED AND NON-FORMED. BLEEDING WAS CONTROLLED WITH HARMONIC SCALPEL AND EVENTUALLY CLIPS WERE APPLIED. THERE WAS NO PT CONSEQUENCE.
THE "GAS LOSS" ALARM SOUNDED FROM THE PUMP ABOUT 30 MINUTES AFTER THE IAB WAS INSERTED. NO BLOOD WAS VISUALIZED IN THE TUBING AND THE GAS ALARM WAS OVERRIDDEN. BLOOD WAS NOTED IN THE TUBING 26 HOURS AFTER THE IAB WAS INSERTED.
ACCORDING TO MEDWATCH FROM HOSP, "STAFF INVOLVED BELIEVES 25 LBS OF PRESSURE WAS NOT MAINTAINED ON PADDLES, CAUSING "ARCING" AND FIRE. AT TIME OF INCIDENT PT HAD "VASELINE DRESSINGS" ON CHEST FROM CABG PROCEDURE. INCIDENT OCCURRED DURING A CODE AND THINGS WERE PRETTY TENSE AT THE BEDSIDE. PT SURVIVED, GRAFTS WERE SUCCESSFUL AND THE PT IS STILL DOING WELL. AGAIN EMPHASIZED THAT THE PERSON HOLDING THE PADDLES WAS "SMALL" AND PROBABLY WAS NOT MAINTAINING THE REQUIRED PRESSURE ON THE PADDLES. THE DEFIB WAS CHECKED BY BIO-MEDS WITH NO TROUBLE FOUND. HAS BEEN EXAMINED IN ROUTINE MAINTENANCE SINCE EVENT, AGAIN WITH NO TROUBLE FOUND. DEFIB REMAINS IN SERVICE IN THE ICU. CONCLUSION: USER'S FAILURE TO MAINTAIN ADEQUATE PRESSURE ON PADDLES DURING DEFIBRILLATION LED TO THE ARCING WHICH CAUSED THE BURNS ON THE PT'S LEFT FOREARM. NO DEVICE FAILURE.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE.  REPORTEDLY, THE STAPLE LINE DID NOT FORM WELL.
9/20/96-MEDWATCH NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
LOSS OF INTEGRATION OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS 1 OF 6 PLACED; WAS PLACED IN SITE #28. RESORBABLE MEMBRANE WAS USED. CLINICIAN ATTRIBUTES LOSS TO PT BEING A SMOKER.
DR. REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE.
THE DEVICE WAS PLACED ON 5/24/96, AND WAS REMOVED ON 5/30/96 DUE TO REDNESS, DRAINAGE AND HARDNESS AT THE STOMA SITE. FACILITY REPORTED INTERMITTENT OCCURRENCES OF ENTERAL FEEDING SOLUTION NOT INFUSING AND OF PT GRIMACING AS IF IN PAIN WHEN ATTACHING TUBING. THE PT TYPICALLY DID EXTREMELY WELL WITH THE DEVICE. PT RECEIVED ANTIBIOTICS SECONDARY TO THIS PROBLEM. ONE PT INVOLVED.
CO'S STANDARD PROCEDURE INCLUDES SENDING THE REPORTER A MEDWATCH FORM FOR COMPLETION AND RETURN. IN THIS CASE, THE RPTR DID NOT PROVIDE THE REQUIRED INFO FOR THE FOLLOWING SECTIONS: A1;F2,F6,F9,F10 OR F11. SAMPLE WAS RECEIVED WITH NO VISUAL DEFECTS. THE FUNCTIONAL TESTING WAS PERFORMED, UNABLE TO DUPLICATE COMPLAINT. NO DEFECTS WERE FOUND. 10/25/96 SAMPLE WAS FUNCTIONALLY TESTED ON A COMPANION PUMP WITH SET AND OSMOLITE. PUMP WAS SET AT 300ML/HR AND RAN FOR ONE HR W/NO LEAKING OR DEFECTS OF ANY KIND WERE FOUND. SAMPLE WORKED AS IT SHOULD.
UPON OPENING, IT WAS NOTICED THAT THE INNER PACKAGING OF THE NAIL HAD BEEN COMPROMISED. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
THE DEVICE WAS NOT MANUFACTURED IN THE U.S. EVALUATION OF THIS DEVICE IS TO BE PERFOMRED AT THE MANUFACTURING FACILITY. INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THREE IMPLANTS WERE PLACED IN 5/96 IN SITES 18, 19, 20. IMPLANTS IN SITES 18 AND 20 WERE REMOVED ONE MONTH LATER. CLINICIAN BELIEVES FAILURE MAY HAVE BEEN DUE TO PT HAVING OSTEOPOROSIS.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. DRAINAGE WAS INITIALLY REPORTED AND THE PT WAS PLACED ON AN ANTIBIOTIC. A NODULE WAS PRESENT AND GRANULATION TISSUE REMOVED. THE DR. REPORTED THAT THE PT WORE A TEMPORARY FLIPPER AND IS A SMOKER, BOTH OF WHICH MAY HAVE BEEN CONTRIBUTING DACTORS. THIS IS THE SAME PT REPORTED IN MFR #20290121996-00032.
86 = DIMENSIONAL ANALYSIS. 100 = VISUAL EXAMINATION SHOWED TOOL MARKS ON THE BASKET ON THE IMPLANT, POSSIBLE DUE TO THE REMOVAL PROCEDURE. THE DIMENSIONAL SPECS IN ALL RESPECTS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED THE DEVICE DID NOT SOUND NORMAL AFTER THE SECOND FIRING. AFTER RELOADING FOR THE THIRD FIRING, THE DEVICE MADE A LOUD CRACKING SOUND. A SECOND DEVICE WAS INTRODUCED TO COMPLETE THE PROCEDURE. AT THE END OF THE PROCEDURE, STAFF WAS UNABLE TO IDENTIFY WHICH DEVICE WAS THE PROBLEM, SO BOTH ARE BEING RETURNED. THERE WAS NO PT CONSEQUENCE.
10/07/96 1200 MESSAGE AND 800 LEFT ON OFFICE ANSWERING MACHINE. SECTIOND: ALL INFO IN D1 THROUGH D10, WITH THE EXCEPTION OF BATCH NUMBER IS THE SAME FOR PRODUCT #2. BATCH NUMBER FOR PRODUCT #2 IS H0035M. SECTION H: ALL INFO IN H1 THROUGH H10, WITH THE EXCEPTION OF H6, IS THE SAME FOR PRODUCT #2. EVAL CODES FOR PRODUCT #2 ARE AS FOLLOWS: A1,2,4, B6,7;D5, 10: H4 INFO AVAILABLE. BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE CARTRIDGE RETURNED WITH INSTRUMENT A HAD AN ALIGNMENT FINGER FROM ANOTHER CARTRIDGE JAMMED IN THE LEFT WEDGE SLOT. INSTR. A WAS RETURNED WITH A BENT LEFT FIRING WEDGE AND BROKEN SHORT RACK TEETH. IT WAS CONCLUDED THAT THE INSTR. HAD BECOME DAMAGED DUE TO THE ALIGNMENT FINGER FROM A PREVIOUS CARTRIDGE BEING JAMMED IN THE LEFT WEDGE SLOT OF THE RETURNED CARTRIDGE. NO TESTING COULD BE PERFORMED DUE TO THE CONDITION OF INSTR. A: NO CONCLUSION COULD BE REACHED AS TO HOW THE PREVIOUS CARTRIDGE HAD BECOME DAMAGED. INSTR. B WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE INSTR WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS WERE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTR  WAS FULLY FUNCTIONAL AND CONFORMING TO SPECS. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PRODEDURE, THE CLIPS DID NOT FORM PROPERLY AND BLEEDING WAS OBSERVED. THE SURGEON APPLIED ANOTHER DEVICE TO CONTROL THE BLEEDING. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DENTAL ASSISTANT REPORTED THAT AN ABUTMENT BROKE IN FUCTION. PT IS REPORTEDLY FINE.
THE TIBIAL INSERT WOULD SEAT PROPERLY IN THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE RESULTS FO THE MFR'S EVALUATION SUGGESTS THIS EVENT IS NOT DEVICE RELATED BUT IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES.
A PHYSICIAN REPORTED A PT WAS TREATED ON 9/4/96 INTO THE LEFT NASOLABIAL FOLD, FROWN LINE, AND VERTICAL LIPSTICK LINES. ON 9/11/96, THE PT DEVELOPED PRURITUS, TENDERNESS, AND A DARK RED BRUISED APPEARANCE AT THE LEFT NASOLABIAL FOLDS AND FROWN LINE. ON 9/11/96, ORAL AND TOPICAL ANTIHISTAMINES WERE PRESCRIBED. THE PT ALSO DEVELOPED A MIGRAINE TYPE HEADACHE AND VOMITING, WHICH LASTED FOR TWO TO THREE WEEKS. THE PHYSICIAN BELIEVED THE SYMPTOMS AT THE LEFT NASOLABIAL FOLD AND FROWN LINE WERE RELATED TO THE COLLAGEN; HE WAS UNSURE IF THE MIGRAINE AND VOMITING WERE RELATED TO THE COLLAGEN.
THE PT ALLEGED THAT FOR TWO YRS SINCE THE TREATMENT SHE HAD PAIN TO HER FACE, HEADACHES, AND CREVICE TYPE SCARRING TO ONE SIDE OF HER FACE.
DR. REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PATIENT IS REPORTEDLY FINE.
DURNG AN UNSPECIFIED PROCEDURE, THE SUTURE BROKE WHILE LIGATING. NO PT INJURY REPORTED.
WE RECEIVED ONE CLINICAL AND SEVERAL REP PACKAGES OF THE SUBJECT SUTURE. FRAYING WAS OBSERVED ON THE CLINICAL SAMPLE WHICH COULD HAVE BEEN THE RESULT OF POOR HANDLING BY THE USER BUT THE EXACT CAUSE OF THIS CONDITION COULD NOT BE RELIABLE DETERMINED. THE REP SUTURE WAS TESTED AND MET THE APPROPRIATE STRENGTH SPECIFICATIONS WITH NO ABNORMALITIES OBSERVED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC RIGHT OOPHERECTOMY. IT WAS REPORTED THE DEVICE STAPLED AND DID NOT CUT. THE DEVICE WAS DIFFICULT TO OPEN AND REMOVE FROM TISSUE. A SECOND DEVICE WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
DAMAGED FIRING MECHANISM. 10/04/96 1450 MESSAGE AND 800 LEFT FOR MD CALL . 10/06/96 NNCL SENT. A1,2,3,4; B6,7; D5,6,10; H4: INFO UNAVAILABLE. BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
THE PRODUCT WAS NOT CLINICALLY APPLIED. REPORTEDLY, THE SUTURE BROKE WHILE REMOVING FROM PACKAGE.
9/20/96- MEDWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
DURING AN UNSPECIFIED PROCEDURE. THE SUTURE KNOTS UNTIED. THE SURGEON TIED ADD'L KNOTS WITH ANOTHER SUTURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
UNERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
THE IAB WAS INSERTED INTO THE PATIENT ON 9/28/96. ON 9/30/96 AFTER IABP FOR 63 HOURS, BLOOD WAS NOTED IN THE TUBING AND THE PUMP WAS SHUT OFF. THE IAB WAS REMOVED WITHOUT ANY PROBLEMS. EVENT COMPLICATIONS: UNK - REPORTED 10/1/96; NONE - REPORTED 10/18/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 10/1, 10/18/96.
DURING AN UNSPECIFIED PROCEDURE, THE SUTURE KNOTS UNTIED. THE SURGEON TIED ADD'L KNOTS WITH ANOTHER SUTURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
FIVE PTS EXPERIENCED SYMPTOMS OF NAUSEA/VOMITING AND ABDOMINAL PAIN DURING DIALYSIS. UPON INVESTIGATION BY THE MFR, IT WAS DETERMINED THAT 3 OF THE PTS COULD NOT BE CONFIRMED TO HAVE BEEN DIALYZING ON ANY OF THE 4 SUSPECT MACHINES. THIS IS DUE TO THE MACHINE SERIAL NUMBER (OR DESIGNATED FACILITY MACHINE NUMBER) NOT BEING DOCUMENTED ON THOSE PTS' TREATMENT RECORDS. THE LAST 2 INCIDENTS WHICH OCCURRED, WERE DETERMINED TO HAVE OCCURRED ON THE SAME MACHINE (SN 4EOS-H974). THIS MACHINE WAS REMOVED FROM THE TREATMENT AREA, AS WERE THE OTHER 3 MACHINES SUSPECTED OF MALFUNCTIONING. ALL THE PTS INVOLVED RECOVERED. THE LAST PT INVOLVED, DIALYZED ON MACHINE SN 4EOS-H974, AND EXPERIENCED AN ASTHMA ATTACK PRECIPATED BY THE PT VOMITING. THE PT WAS SENT TO THE EMERGENCY ROOM, RECEIVED A BREATHING TREATMENT, LAB WORK WAS DRAWN AND THE PT RETURNED TO THE FACILITY TO COMPLETE THE DIALYSIS TREATMENT. THE FACILITY STATES THE LAB WORK DRAWN IN THE ER DID NOT INDICATE ACIDOSIS, BUT THEY COULD NOT PROVIDE THE LAB RESULTS. ALL 4 SUSPECT MACHINES WERE INVESTIGATED BY THE MFR. THREE OF THESE MACHINES WERE FOUND TO BE WITHIN SPECIFICATIONS AND OPERATING PROPERLY. THE INVESTIGATION OF ONE MACHINE (SN 4EOS-H974) SHOWED AN UNSTABLE CONDUCTIVITY OF 13.1 AND PH OF 6. ACCORDING TO THE FACILITY THIS MACHINE HAD AN APPROPRIATE CONDUCTIVITY AND PH PRIOR TO THE TREATMENT AND NO ALARMS OCCURRED DURING THE TREATMENT. THE INVESTIGATION FOUND THAT THE BICARBONATE PUMP INLET LINE WAS OCCLUDING INTERMITTENTLY AND THE ACID PUMP WAS CALIBRATED 3ML HIGH. IN THIS CONDITION, THE MACHINE COULD NOT HAVE OBTAINED A CONDUCTIVITY OF 13.8 AND PH OF 7.4, UNLESS THE ACID PUMP HAD BEEN MANUALLY ADJUSTED. THE FACILITY STATES THAT NO ADJUSTMENTS WERE MADE TO THE MACHINE. THE MACHINE WAS RECALIBRATED AND THE BICARB PUMP INLET LINE ADJUSTED, PROPER MACHINE OPERATION VERIFIED.
THE ANTERIOR SNAP FIT MECHANISM BROKE UPON INSERTION. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
H4: MFG DATE = 7/90. SUMMARY OF EVALUATION: EVALUATION RESULTS INDICATE THAT THIS EVENT MAY HAVE BEEN DUE TO THE ITEM BEING 5 YEARS AND 5 MONTHS AFTER STERILIZATION AT THE TIME OF SURGERY.
A PT REPORTED THAT SHE WAS TESTED ON 4/12/96 AND TREATED ON 5/16/96 IN THE NASOLABIAL FOLDS AND ORAL COMMISURES. ON 5/30/96, THE PT PRESENTED WITH LACK OF CORRECTION AT THE TREATMENT SITES. THE PHYSICIAN BELIEVED THAT ADD'L MATERIAL WAS NEEDED. IN APPROX 7/96 (EXACT DATE NOT RECALLED), THE PT NOTED REDNESS AND SWELLING AT THE SKIN TEST SITE; SHE ALSO RECEIVED FAT INJECTIONS INTO THE COLLAGEN TREATMENT SITES BY ANOTHER PHYSICIAN. IN 10/96 (EXACT DATE NOT RECALLED), THE PT NOTED A SORE THROAT, EAR PAIN AND PRESSURE, AND SINUS CONGESTION WHICH SHE BELIEVED WERE RELATED TO A "COLD". SHE TOOK SELF-PRESCRIBED SUDAFED. ON APPROX 10/21/96, THE PT NOTED A "RAISED, PURPLE LUMP" AT A LEFT NASOLABIAL FOLD WHICH DRAINED SPONTANEOUSLY. SHE APPLIED SELF-PRESCRIBED NEOSPORIN. ON 10/21/96, SHE PRESENTED TO A CONSULTING PHYSICIAN (NAME REFUSED) WHO PRESCRIBED ORAL KEFLEX. ON 10/30/96, THE PT PHONED THE OFFICE AND ALLEGED "RED LUMPS" AT THE TREATMENT SITES. ON 11/4/96 SHE PRESENTED WITH ERYTHEMA AND INDURATION AT BOTH NASOLABIAL FOLDS. THE PHYSICIAN DIAGNOSED ABSCESS FORMATION; ORAL KEFLEX AND WARM COMPRESSES WERE PRESCRIBED. HE WAS UNSURE IF THE ABSCESSES ARE RELATED TO COLLAGEN HYPERSENSITIVITY OR TO A COMPLICATION FROM THE FAT TRANSPLANTS. THE PHYSICIAN DID NOT BELIEVE THAT THE ALLEGED SORE THROAT, EAR PAIN AND PRESSURE, AND SINUS CONGESTION WERE RELATED TO COLLAGEN.
THE PHYSICIAN REPORTED THAT NO DIAGNOSIS OR ETIOLOGY HAD BEEN DETERMINED, OR WOULD BE DETERMINED, FOR THE EAR PAIN, SINUS CONGESTION, OR SORE THROAT. THE MULTIPLE COMPLAINTS HAD RESOLVED AS OF 10/19/98.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. THE STAPLES WOULD NOT FORM. THERE WAS NO CONSEQUENCE TO THE PT.
10/04/96 1425 MESSAGE AND 800. FOR MD CALL BACK. 10/06/96 NNCL SENT. 10/09/96 THE SURGEON STATED THE DEVICE MISFIRED EITHER DID NOT FORM ALL THE STAPLES OR DID NOT LAY DOWN AN ENTIRE STAPLE LINE. HE STATED THE FIRING CYCLE FELT NORMAL AND WHEN HE WENT TO PUT THE DEVICE THROUGH, THE RECTUM WAS OPEN. HE USED A PURSE STRING AND ANOTHER TO COMPLETE THE PROCEDURE. THE PT IS AN 80 YEAR OLD FEMALE AND DOING FINE. A1,4;B3,6,7,D5,6,10; H4; INFO UNAVAILABLE.
THE DEVICE HAD COMPLETE LOSS OF ATRIAL CAPTURE. THERE WAS ALSO LOSS OF VENTRICULAR CAPTURE ONLY IN THE LAST CYCLE OF THRESHOLD TESTING.
THE DEVICE WAS USED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO REMOVE FROM THE TISSUE. THE SURGEON MANUALLY REMOVED THE INSTRUMENT AND MANUALLY SUTURED. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
9/19/96- MEDWATCH REPORT NOT RECEIVED BY MFG. INITIAL REPORT SENT TO FDA BY MFG.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. CLINICIAN ADVISED THAT PT REFUSED TO TAKE ANTIBIOTICS, WAS A SMOKER AND DID NOT RETURN FOR REGULARLY SCHEDULED POST-OP VISITS.
DURING A LOW ANTERIOR RESECTION PROCEDURE, THE INSTRUMENT DID NOT STAPLE OR CUT COMPLETELY. THE SURGEON USED A NEW INSTRUMENT TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT THE PT'S CONDITION IS SATISFACTORY.
INTERMITTENT LOSS OF ATRIAL SENSING AND INTERMITTENT LOSS OF ATRIAL CAPTURE WAS OBSERVED.
THE DEVICE WAS APPLIED DURING A COLECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON COMPLETED THE PROCEDURE BY MANUAL SUTURE.
9/19/96 - MEDWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
THE DEVICE WAS USED DURING A SUB-TOTAL GASTRECTOMY PROCEDURE. THE STAPLES DID NOT FORM PROPERLY AT THE DISTAL END. THE SURGEON RESECTED THE TISSUE AT THE APPLICATION SITE AND COMPLETED THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
10/31/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITAL REPORT TO FDA BY MFG.
THE DEVICE WAS USED DURING A LEFT HEMICOLECTOMY WITH ILEUM RESECTION. IT WAS REPORTED THE SURGEON USED IT TO TOP OFF A SIDE TO SIDE ILEO-PROCTOSTOMY. THE STAPLES REPORTEDLY WERE FORMED CORRECTLY, BUT THE STAPLE LINE BLED AND REQUIRED A COMPLETE OVERSEWING WITH SUTURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: INFO UNAVAILABLE. FOR MD CALL BACK. 10/08/96 NNCI SENT KJB. D5,6; H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR EVAL.
THE DEVICE WAS APPLIED DURING A VATS WEDGE RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE. NO PT INJURY REPORTED.
11/4/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE CEMENT DID NOT MIX TO THE PROPER CONSISTENCY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE EVALUATION RESULTS INDICATED NO ABNORMALITIES IN THE CEMENT. ALL TEST RESULTS WERE SATISFACTORILY AND IN ACCORDANCE WITH THE REGISTERED SPEC FOR THE PRODUCT.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT . CLINICIAN NOTES THAT PT WAS A SMOKER AND DID NOT COMPLY WITH THE ANTIBIOTIC REGIMEN. HE ALSO NOTES THAT ONE WEEK PRIOR TO PLACEMENT, 3 IMPLANTS WERE PLACED ON CONTRALATERAL SIDE AND THAT PT MAY HAVE OCCLUDED WITH THIS IMPLANT (#31).
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMS  THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT WAS FIRED TWICE AND WOULD NOT FIRE ON THE 3RD ATTEMPT. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCUDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE IDENTIFIED SCREW BROKE OFF IN THE L5 PEDICLE DURING THE ATTEMPTED INSERTION PROCESS. THE L5 PEDICLE BONE WAS VERY HARD AND DENSE WHICH LED THE ATTENDING PHYSICIAN TO PREDRILL A PILOT HOLE. UPON PARTIAL INSERTION, OF THE SCREW INTO THE PREDRILLED HOLE, GREAT RESISTANCE WAS ENCOUNTERED. SUBSEQUENTLY, THE SURGEON ELECTED TO HIT THE SCREW WITH A MALLET AT WHICH TIME THE SCREW TIP BROKE OFF.
OSTEONICS DISCLAIMER: SUBMISSION OF INFORMATION BY OSTEONICS UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CASUAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFO ACT. THE ORIGIN OF THIS REPORT WAS FROM CO EMPLOYEE. BASED ON THIS, NO MED-WATCH REPORT WAS RECEIVED FROM A USER FACILITY OR A DISTRIBUTOR. THE IDENTIFIED SCREW TIP BROKE-OFF INTRAOPERATIVELY AFTER THE SURGEON PREDRILLED A PILOT HOLE IN THE L5 PEDICLE'S ABNORMALLY DENSE/HARD BONE. THEN, UPON ENCOUNTERING GREAT RESISTANCE DURING THE INSERTION PROGRESS, THE SURGEON ELECTED TO HIT THE SCREW WITH A MALLET TO FURTHER ADVANCE THE SCREW. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE CURRENT PACKAGE INSERT STATES, IN PERTINENT PART "POTENTIAL RISKS ASSOCIATED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADD'L SURGERY, INCLUDE: DEVICE COMPONENT FAILURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY." THE PACKAGE INSERT CONTINUES BY STATING A POSSIBLE ADVERSE EFFECT OF, "BENDING, DISASSEMBLY OR FRACTURE OF ANY OR ALL IMPLANT COMPONENTS." FINALLY, THE SURGICAL PROTOCOL STATES IN PERTIENT PART, "THE SCREW IS STARTED BY TURNING THE SCREWDRIVER LIGHTLY, USING ONLY FINGERTIP PRESSURE. AS THE SCREW IS DRIVEN INTO THE PEDICLE A GRADUAL INCREASE IN RESISTANCE WILL BE FELT." EVALUATION CODES: METHODS: CODE 86 "OTHER"-(EYEWITNESSED ACCOUNT), RESULTS CODE 200 "OTHER"- (ABUSE/MISUSE OF DEVICE DURING ATTEMPTED USE.) CODE 100 "OTHER"0(DEVICE MFG. HISTOR RECORDS CONFIRMED DEVICE WAS MANUFACTURED AS PER SPECIFICATIONS).
THE CHAIR AND PT FELL FROM JIB OF THE LIFT AS CARE STAFF WERE LOWERING THE HOIST TO CONNECT THE SUB-CHASSIS. THE MALE PT WAS TAKEN TO HOSP ON 7/10/96 FOR A SUSPECTED FRACTURED ARM.
FOREIGN REPORTER HAS ASSIGNED INVESTIGATOR AND IS TO FORWARD CLOSING OUT REPORT TO THIS OFFICE.
THE MONOMER AND POLYMER WERE LUMPY AFTER MIXING. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: EVALUATION RESULTS SUGGESTS THAT THIS EVENT IS ATTRIBUTED TO EXTERNAL FACTORS. ALL TEST RESULTS FOR TWO SAMPLE UNITS FROM THE SAME LOT ARE SATISFACTORY AND IN ACCORDANCE WITH THE REGISTERED SPEC FOR THE PRODUCT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT CUT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
9/20/1996 - MEDWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT WAS FIRED TWICE AND WOULD NOT FIRE ON THE 3RD ATTEMPT. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
CUSTOMER INDICATED SAMPLES WOULD BE RETURNED TO CO FOR EVALUATION. SAMPLES WERE NOT RECEIVED. THIS MDR IS BEING CLOSED WITHOUT BENEFIT OF RETURNED PRODUCT. BASED ON INFO FROM PREVIOUS SIMILAR COMPLAINTS, CO BELIEVES THAT THIS IS RELATED TO THE BLUE BALL NOT SEATING DUE TO THE SEAT BEING DEFORMED. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED VACUUM TESTING DURING ASSEMBLY TO DETECT THIS ISSUE. THIS LOT WAS MANUFACTURED PRIOR TO THIS CHANGE. CO IS UNABLE TO CONFIRM THIS ISSUE BUT IT ABLE TO DETERMINE THE PROBABLE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVALUATION. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
ACCORDING TO THE MEDWATCH FORM SENT TO CO "PT CONNECTED TO CHEST DRAINAGE SYSTEMS THAT FAILED TO CREATE SUCTION POST-OP CAB. PT EXPERIENCED CARDIAC ARREST ON TRANSFER FROM OR TABLE TO STRETCHER. HE WAS PLACED BACK ON O.R. TABLE AND REOPENED. HE WAS DEFIBRILLATED AND NORMAL SINUS RHYTHM RESUMED. AT THIS TIME CO IS STILL UNCERTAIN AS TO THE CAUSE OF THE EVENT. THE PHYSICIAN DOCUMENTED IN THE RECORD THAT THE SYSTEM APPEARED TO HAVE FAILED. HOWEVER, THE O.R. DIRECTOR FEELS THAT THERE IS A POSSIBILITY OF USER ERROR. UNFORTUNATELY THE EQUIPMENT WAS RELEASED TO CO REP AND CO IS UNABLE TO TEST THE SYSTEM. CO WILL CONTINUE TO FOLLOW UP & INVESTIGATE WITH THE STAFF."
CO IN-HOUSE EVAL OF THE RETURNED UNIT REVEALED NORMAL FUNCTIONING OF THE CHEST DRAIN.
THE PREMATURE END-OF-LIFE INDICATOR WAS OBSERVED.
THE DEVICE WAS SUBJECTED TO BATTERY DISCHARGE ANALYSIS AND FOUND TO BE PARTIALLY DEPLETED-NORMAL. THE OBSERVED NON RESPONSE TO MOTION WAS THE RESULT OF A MALFUNCTION IN THE ACCELEROMETER DUE TO AN "OPEN BETWEEN THE "PADDLE" AND HYBRID CIRCUIT CONNECTION.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE INNER LUMEN. UNDER MICROSCOPY, A SEPARATION OF THE INNER LUMEN WAS SEEN. THE ROUGH EDGED POINTS OF SEPARATION OF THE INNER LUMEN WAS SEEN. THE ROUGH EDGED POINTS OF SEPARATION WERE IRREGULAR IN CONTOUR SUGGESTING THAT THE INNER LUME BROKE. THE BROKEN PORTION OF THE INNER LUMEN HAD A WHITISH APPEARANCE, INDICATING A POINT OF STRESS. PROBABLE CAUSE OF DIFFICULTY: THE IAB LEAK WAS THE RESULT OF A BREAK OF THE INNER LUMEN. IT IS POSSIBLE THAT THE IAB WAS RESTRAINED WITHIN THE AORTA DURING IABP. THIS WOULD HAVE RESULTED IN  A CYCLICAL STRESS TO THE INNER LUMEN AND, ULTIMATELY, A SEPARATION AT THE POINT OF STRESS. THE IAB MAY HAVE BEEN RESTRAINED AS A RESULT OF PLACEMENT WITHIN A SUBINTIMAL SPACE OR UNDERNEATH PLAQUE. IT IS ALSO POSSIBLE THAT THE INITIAL KINK IN THE INNER LUMEN WAS MADE DURING IAB INSERTION AND THAT IABP CONTINUED TO CYCLICALLY STRESS THE INNER LUMEN AT THAT POINT.
PATIENT'S CURRENT STATUS: UNK - RPT'D 10/1/96.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
THE PRODUCT WAS APPLIED DURING A TOTAL LARYNGECTOMY PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.
9/20/96- MEDWATCH REPORT NOT RECEIVED BY MANUFACTURE. SUBMITTED INITIAL REPORT.
UPON OPENING THE PACKAGE A PIECE OF WHITE PLASTIC MATERIAL, APPROX 1MM THICK BY 3MM LONG, WAS FOUND IN THE TUBING ABOVE THE POINT WHERE THE TUBING HOOKS INTO THE PUMP. THIS PROBLEM WAS DISCOVERED PRIOR TO USE AND WAS THEREFORE NEVER USED.
LOSS OF INTEGRATION OF ENDOSSEOUS DENTAL IMPLANT. CLINICIAN HAD PLACED 4 IMPLANTS IN THE EDENTULOUS MAXILLA. AFTER 2 WEEKS, PT WAS PERMITTED TO WEAR A TEMPORARY MAXILLARY FULL UPPER DENTURE WITH THE ACRYLIC COMPLETELY RELIEVED OVER THE IMPLANTS. WITHIN 4-5 WEEKS, THE PT HAD PIVOTED THE DENTURE INTO THE IMPLANTS AND OVERLOADED THIS IMPLANT WITH HEAVY CHEWING FORCES. CLINICIAN BELIEVES OVERLOAD CAUSED LOSS OF INTEGRATION.
INVESTIGATION OF THE REFERENCED COMPLAINT HAS BEEN COMPLETED. THE COMPLAINT ON THE DEVICE STATING THAT "THE PENCILS ARE STICKING IN THE ON POSITION." WAS RECEIVED 10/3/96 AND A MALFUNCTION MDR WAS FILED BASED ON THE INFO PROVIDED THAT NO INJURY OCCURRED HOWEVER REOCCURRENCE MAY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THE DEVICE WAS NOT RETURNED FOR EVALUATION BY CO LABS. DEVICES TESTED FROM SIMILAR LOTS OPERATED NORMALLY WITH NO STICKING OF THE SWITCHES OBSERVED. THE PENCIL CONFIGURATION WAS EXAMINED THROUGHOUT THE SWITCHCORE AREA AND THERE WAS NO EVIDENCE THAT INDICATED HOW THE SWITCHES COULD BECOME STUCK ON OR REMAIN ACTIVE FROM ANY OTHER IDENTIFIED MALFUNCTION TYPE. THE PENCIL WAS FROM A LOT MANUFACTURED IN 5/96 AND THIS CONFIGURATION DEVICE HAS HAD NO OTHER REPORTS OF STICKING. CO REGRETS THAT THE INCIDENT OCCURRED, ALTHOUGH SINCE NO DEVICE WAS AVAILABLE FOR EVALUATION, NO CAUSE FOR THE STICKING ON COULD BE IDENTIFIED WITH THIS CONFIGURATION. THE USER IS REMINDED THAT TO PREVENT INJURY FROM ACCIDENTAL ACTIVATIONS, GOOD ELECTROSURGERY PRACTICE REQUIRES THAT ACTIVE ACCESSORIES BE STORED IN THE SAFETY HOLSTER PROVIDED WHEN THEY ARE NOT IN USE.
THE PUMP WAS SET AT 16 ML/HR TO DELIVER A 250ML BAG THE PT'S BLOOD PRESSURE DROPPED AND IT WAS NOTED THAT THE BAG WAS EMPTY. IT IS UNKNOWN WHAT PERIOS OF TIME HAD PASSED. THE INFUSION WAS CEASED, AND A RESUSCITATIVE DRUG WAS GIVEN. THERE WAS NO PT CONSEQUENCE.
MFR'S REPORT DATE 11/1/96. THE PUMP WAS RETURNED FOR EVAL. VISUAL INSPECTION REVEALED THE INSTRUMENT'S OVERLAY (TOUCH PANEL) WAS DELAMINATED AND DAMAGED. THE LEFT BOTTOM CORNER WAS ALSO DAMAGED. THE INSPECTION SEAL AND THE START-UP PROCEDURE LABEL WERE MISSING. FUNCTIONALLY, THE INSTRUMENT WAS TESTED AND FOUND TO MEET ALL MFR'S SPECIFICATIONS. THE ACCURACY WAS TESTED AT SEVERAL RATES AND PASSED ALL TESTS. IT IS SUSPECTED THAT A POSSIBLE MISLOAD OF THE IV SET MAY HAVE CAUSED THE REPORTED OVERINFUSION. ADDITIONAL INSERVICING WILL BE RECOMMENDEDON PROPER LOADING OF THE IV SET PER THE DIRECTIONS FOR USE, PAGE 9, WHICH STATES, "CLOSE THE MECHANISM BY PUSHING THE ORANGEE LATCH TO THE LEFT. VERIFY THE TUBING IS FULLY WITHIN THE MECHANISM AND THE AIR-IN-LINE DETECTOR... DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH." THIS ENTIRE MEDWATCH REPORT WAS COMPLETED BY THE MFR. INFO SHOWN AS "UNK" WAS NOT AVAILABLE FROM THE USER FACILITY WHEN THIS REPORT WAS COMPLIED.
PT S/P CVA AND HIGHLY AGITATED WAS BANGING SIDE RAILS AND BENDING THEM UNTIL THEY WERE HORIZONTAL TO PT'S BED. AFTER DOING THIS TWICE, THE RAIL MATERIAL (PIPING) SPLIT LEAVING A JAGGED EDGE.
THE DEVICE WAS USED DURING A VATS. IT WAS REPORTED BY THE REP THAT ON THE SECOND FIRE THE INSTRUMENT BROKE. THE NEW INSTRUMENT WAS OPENED TO FINISH THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: INFO NOT SUPPLIED BY AFFILIATE. D5; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
LOSS OF INTEGRATION OF 2 ENDOSSEOUS DENTAL IMPLANTS. IMPLANTS WERE PLACED, IN SITES #17 AND #19 IN CONJUCTION WITH RESORBABLE MEMBRANES. CLINICIAN REPORTS PT WAS A SMOKER, WITH A POOR LIFE STYLE.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS ENDOSSEOUS DENTAL IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE IS PUBLISHED IN THE SCIENTIFIC LITERATURE.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT WOULD NOT FIRE. THE SURGOEN APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
ON THREE SEPARATE OCCASIONS A DOTTED LINE APPEARED ON THE UNIT'S MONITOR SCREEN. ON TWO OCCASIONS, THE UNIT WAS IN USE ON A PT. BOTH TIMES MEDICS WERE MONITORING PTS (AGES AND GENDERS UNK) AND WHEN THE MEDICS SWITCHED THE UNIT FROM AED TO MANUAL MODE, THE DOTTED LINE APPEARED. THE MEDICS TRIED TO SWITCH LEADS, BUT THE DOTTED LINE REMAINED. THEY WERE EVENTUALLY ABLE TO OBTAIN A RHYTHM. THERE WAS NO ADVESE EFFECT ON EITHER OF THE PTS. ON THE THIRD OCCASION, MEDICS WERE TESTING THE UNIT AND THE DOTTED LINE APPEARED ON THE UNIT'S MONITOR SCREEN. THE MEDIC ADJUSTED THE CABLE PORT, CHANGED LEADS, AND THE ECG TRACE REAPPEARED ON THE SCREEN.
THE DEVICE WAS USED DURING A HERNIA REPAIR. IT WAS REPORTED BY THE REP. JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
H6; EXCESSIVE BODY FLUIDS IN CARTYRIDGE AREA, BROKEN NOSE WELD. CONCLUSION: IT WAS CONCLUDED THAT EXCESSIVE DRIED BODY FLUIDS AND TISSUE IN THE CARTRIDGE ASSEMBLY MAY HAVE CAUSED THE RPT'D INCIDENT. THE INST. WAS RECEIVED WITH EXCESSIVE DRIED BODY FLUIDS AND TISSUE IN THE CARTRIDGE ASSEMBLY AND THE NOSE WELD WAS BROKEN. THE DRIVER AND LIFTER WOULD NOT MOVE DUE TO THE ADHERENCE WITH DRIED FLUIDS AND TISSUE. THE DRIVER AND LIFTER WERE EXTRICATED AND TEH INST. WAS CYCLED FIRING 8 STAPLES FORMING PROPERLY, BUT DURING THE FIRING, 4 STAPLES WERE REMOVED FROM THE NOSE DUE TO INVERTING. THE STAPLES INVERTED DUE TO THE BROKEN NOSE WELD. THE INST'S. CARTRIDGE WAS DISASSEMBLED AND THERE WERE 2 STAPLES REMAINING IN THE CARTRIDGE WHICH WOULD NOT FEED DUE TO THE EXCESSIVE DRIED BODY FLUIDS AND TISSUE IN THE CARTRIDGE ASSEMBLY. IT WAS CONCLUDED THAT THE EXCESSIVE DRIED FLUIDS AND TISSUE MAY HAVE CAUSED THE STAPLES TO TWIST AND JAM IN THE NOSE WHICH MAY HAVE CAUSED THE NOSE WELD TO YIELD. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
THE BONE CEMENT SET PREMATURELY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
THE SURGEON DISCARDED ONE MIX OF CEMENT. AS A RESULT, SAMPLES OF THE CEMENT LOT IN QUESTION WERE NOT RETURNED FOR EVALUATION. SAMPLES OF THE COMPONENTS WITH THE SAME LOT REFERENCED IN THIS REPORT WERE RETRIEVED FROM RETAINED SAMPLE STORAGE. THE POWDER AND LIQUID COMPONENTS WERE MIXED TOGETHER BY LABORATORY PERSONNEL USING MANUAL PROCEDURES. ALL TESTING WAS PERFORMED AT STANDARD LABORATORY CONDITIONS OF 20 DEGREES + 1C DEGREES AND 60H + _20% RH, FOLLOWING EQUILIBRATION OF THE TEST SAMPLES AND MIXING EQUIPMENT TO THESE CONDITIONS FOR 24 HOURS MINIMUM. ALL TEST RESULTS ARE SATISFACTORY AND IN ACCORDANCE WITH THE REGISTERED SPECIFICATION FOR THE PRODUCT.
INVESTIGATION OF THE REFERENCED COMPLAINT HAS BEEN COMPLETED. THE COMPLAINT ON THE DEVICE STATING THAT "THE PENCILS ARE STICKING IN THE ON POSITION." WAS RECEIVED 10/3/96 AND A MALFUNCTION MDR WAS FILED BASED ON THE INFO PROVIDED THAT NO INJURY OCCURRED HOWEVER REOCCURRENCE MAY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THE DEVICE WAS NOT RETURNED FOR EVAL BY CO LABS. DEVICES TESTED FROM SIMILAR LOTS OPERATED NORMALLY WITH NO STICKING OF THE SWITCHES OBSERVED. THE PENCIL CONFIGURATION WAS EXAMINED THROUGHOUT THE SWITCHCORE AREA AND THERE WAS NO EVIDENCE THAT INDICATED HOW THE SWITCHES COULD BECOME STUCK ON OR REMAIN ACTIVE FROM ANY OTHER IDENTIFIED MALFUNCTION TYPE. THE PENCIL WAS FROM A LOT MANUFACTURED IN 5/96 AND THIS CONFIGURATION DEVICE HAS HAD NO OTHER REPORTS OF STICKING. CO REGRETS THAT THE INCIDENT OCCURRED, ALTHOUGH SINCE NO DEVICE WAS AVAILABLE FOR EVALUATION, NO CAUSE FOR THE STICKING ON COULD BE IDENTIFIED WITH THIS CONFIGURATION. THE USER IS REMINDED THAT TO PREVENT INJURY FROM ACCIDENTAL ACTIVATIONS, GOOD ELECTROSURGERY PRACTICE REQUIRES THAT ACTIVE ACCESSORIES BE STORED IN THE SAFETY HOLSTER PROVIDED WHEN THEY ARE NOT IN USE.
THE DEVICE WAS THIN-WALLED AT THE TIP. THIS WAS OBSERVED WHEN ATTEMPTING TO USE THE OBTURATOR FOR PLACEMENT. THE DEVICE WAS NOT USED FOR FEAR OF PERFORATION OF OBTURATOR THROUGH THE TIP. ONE PT INVOLVED.
CO'S STANDARD PROCEDURE INCLUDES SENDING THE RPTR A MEDWATCH FORM FOR COMPLETION AND RETURN. IN THIS CASE, THE RPTR DID NOT PROVIDE THE REQUIRED INFO FOR THE FOLLOWING SECTIONS: A1;F2,F9,F10,AND F11. LAB REPORT STATES THE TUBE TIP WAS SPLIT VERTICALLY. THIS WAS DONE BY A MFR'S REP AT THE RPTR'S SITE; IT WAS NOT A DEFECT SEEN BY THE RPTR. SAMPLE WAS RECEIVED WITH THE TIP IN HALF, UNABLE TO DETERMINE CAUSE. NO OTHER DEFECTS WERE FOUND.
GRASEBY MEDICAL DOES NOT BELIEVE THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT IS ATTRIBUTABLE TO THE DEVICE OR THAT REMEDIAL ACTION IS REQUIRED. CO BELIEVES THE DIFFICULTY WITH THE 8C4220 ADMINISTRATION SET EXPERIENCED BY THE HOSP IS DUE TO EXCESSIVE AIR-IN-LINE CAUSED BY THE INCOMPATIBILITY OF THE ABBOTT LIFESHIELD NEEDLE WITH THE GRASEBY Y-SITE.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
REMOVAL OF 2 ENDOSSEOUS DENTAL IMPLANTS. IMPLANTS WERE 2 OF 4 PLACED (SITES 2,6,11,15). RESORBABLE MEMBRANE WAS USED AT SITES 2 & 15, SINUS LIFT WAS PERFORMED, IMPLANTS AT SITES 2 AND 15 FAILED AND WERE REMOVED.
AN ABUTMENT SCREW FRACTURED INSIDE IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN AFTER FIRING. THE DEVICE WAS REMOVED FROM TISSUE. THE STAPLE LINE WAS INTACT. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/19/96- MEDWATCH RECEIVED 9/9/96 FROM FDA WITH ACCESS NUMBER 1009804. INITIAL REPORT SUBMITTED TO FDA BY MFG.
DURING IMPLANTATION, THERE WAS A SLIGHT MOTION OF THE LINER IN THE ACETABULAR SHELL. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: EVALUATION OF THIS EVENT CANNOT BE PERFORMED BECAUSE THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE DEVICE WAS DISCARDED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THERE IS INSUFFICIENT INFO PROVIDED TO DETERMINE WHETHER THIS EVENT WOULD BE DEVICE RELATED.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE SURGEON TRIED TO APPLY CLIPS AND THE CLIPS WOULD NOT FORM COMPLETELY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1, 2,3,4: B6,7; D10: INFO UNAVAILABLE. IS OUT OF TOWN. WILL SEND NNCL. D5,6; H4: INFO COULD NOT BE DETERMINED. BASED UPON THE INQUIRY INFO REC'D THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPEC WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. THE INSTRUMENT MUST BE FIRED UNTIL THE TRIGGER MEETS THE HANDLE TO ENSURE THE CLIP BEING APPLIED IS FULLY FORMED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
9/20/96-MEDWATCH REPORT NOT RECEIVED BY MANUFACTURE. SUBMITTED INITIAL REPORT.
FEEDING PUMP MALFUNCTIONED CAUSING RAPID INFUSION OF FEEDING INTO STOMACH (600 CC) IN 1 HR 15 MINUTES. PUMP VOLUME INFUSED READ 75 CC. THE PT VOMITTED FOLLOWING THE EVENT. STAFF ATTEMPTED TO ASPIRATE STOMACH CONTENTS. THERE WAS NO ILLNESS, INJURY OR MEDICAL INTERVENTION RESULTING FROM THE EVENT. ONE PT INVOLVED. NOTE: THIS EVENT OCCURRED IN 1995, THUS THE REPORTER WAS NOT ABLE TO PROVIDE ANY FURTHER DETAILS.
CO STANDARD PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE REPORTER FOR COMPLETION AND RETURN. IN THIS CASE, THE EVENT OCCURED ABOUT 20 MONTHS AGO, THUS THE REPORTER WAS UNABLE TO GIVE FURTHER DETAILS. NO DEVICE SERIAL NUMBER WAS IDENTIFIED, MAKING IT IMPOSSIBLE TO ESTABLISH WHICH DEVICE WAS INVOLVED OR PROVIDE THE RESULTS OF A LAB INVESTIGATION. THE REPORTER USED FORM 3500 (FOR VOLUNTARY REPORTS), THUS NO INFO WAS PROVIDED FOR SECTION F1-F14. ALSO NO INFO WAS PROVIDED FOR SECTION A1, A4; B2,B6,B7; D10; OR E2.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT FORM PROOPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE USER FACILITY DID NOT RETURN THE PRODUCT FOR EVALUATION.
AN ABUTMENT SCREW FRACTURED INSIDE OF AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
THE STAGED GUIDEWIRE UNRAVELED. THE STAGED GUIDEWIRE WAS NOT RETURNED TO CO FOR EVAL. THE GUIDEWIRE WAS DISCARDED BY THE FACILITY.
THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL.
LOSS OF OSSEOINTEGRATON IN 3 DENTAL IMPLANTS. IMPLANTS WERE 3 OF 13 PLACED. CLINICAN BELIEVES THAT FAILURE MAY HAVE BEEN DUE TO PT WEARING DENTURE PRESSED ON IMPLANTS.
THE DEVICE WAS APPLIED DURING A GASTRIC BANDING PROCEDURE. REPORTEDLY, THE SEAL DISENGAGED. THE SURGEON APPLIES ANOTHER INSTRUMENT TO COMPLETE THE   PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
A RIGHT NAIL WAS LABELED AS A LEFT NAIL. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
A VISUAL INSPECTION REVEALED ENGRAVING AND POSITION OF THE PROXIMAL SCREW HOLE CORRESPOND TO CO SPECIFICATIONS. A REVIEW OF THE MFG DOCUMENTS SHOWS NO DEVIATIONS DURING THE MFG PERIOD. NO OTHER EVENTS OF THIS TYPE WERE REPORTED FOR THIS CODE. EVALUATION RESULTS SUGGEST THAT THE NAIL MUST HAVE BEEN RE-BENT OUTSIDE THE MFG AREA.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, THE STPALES DID NOT FORM PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
9/19/96- MEDWATCH REPORT NOT RECEIVED BY MFG. INITIAL REPORT SET TO FDA BY MFG.
THE DEVICE WAS USED DURING AN LAVH. THE SURGEON FIRED THE DEVICE (4) TIMES. ON THE FIFTH FIRING THE DEVICE JAMMED. THE SURGEON COMMENTED ON THE LACK OF HEMOSTASIS THROUGHOUT THE CASE. DEVICE WAS OPENED TO COMPLETE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
THE BLUE BALL FAILED TO SEAT WHEN THE BURETTE WAS EMPTY ALLOWING AIR TO ENTER TRE LINE.
THE DEVICE WAS APPLIED DURING A GASTRIC BANDING PROCEDURE. REPORTEDLY, THE SEAL DISENGAGED. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/19/96 - MEDWATCH RREPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
TWO ABUTMENT SCREWS FRACTURED INSIDE OF IMPLANTS. THE SURGEON HAD TO PERFORM AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREWS FROM THE IMPLANTS. THE IMPLANTS ARE STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
FURTHER EVALUATION OF DIFFICULTY REPORTED BY HOSP WAS CONDUCTED. IT WAS OBSERVED, WHILE CONDUCTING AN ON-SITE INVESTIGATION OF PROBLEM, THAT AIR-IN-LINE WAS NOTED IN GRASEBY ADMIN SETS ORIGINATING AT UPPER Y-SITE. IT WAS NOTED THAT HOSP USES THE ABBOTT LIFESHIELD NEEDLE TO ACCESS ADMIN LINE UPPER Y-SITE FOR ADMIN OF SECONDARY BAG MEDICATION. CLOSE EXAMINATION OF THESE SETS WITH ABBOTT LIFESHIELD NEEDLES INSERTED INDICATED THAT AIR WAS PASSING THROUGH SEPTUM OF Y-SITE DUE TO LIFESHIELD NEEDLE CANTING IN Y-SITE SEPTUM AND CAUSING SEPARATION IN SEPTUM MATERIAL. DESIGN OF LIFESHIELD NEEDLE IS SUCH THAT WHEN NEEDLE IS INSERTED INTO Y-SITE SEPTUM FULLY, AND NEEDLE SET INTO PLACE BY CAPTURE MECHANISM (AS DESIGNED), NEEDLE IS PUSHED TO ONE SIDE AT AN ANGLE TO SEPTUM RATHER THAN AT 90 DEGREES (PERPENDICULAR) TO THE SEPTUM. THIS NEEDLE ANGLE CAUSES TORQUE ON SEPTUM MATERIAL/NEEDLE CANNULA INTERFACE AND IF TORQUE IS EXCESSIVE, CAN SEPARATE SEPTUM MATERIAL ENOUGH TO CAUSE AIR TO PENETRATE SEPTUM. 8C4220 ADMIN SET UPPER Y-SITE WAS NOT DESIGNED TO BE COMPATIBLE WITH ABBOTT LIFESHIELD NEEDLE.1 GRASEBY Y-SITE IS DESIGNED TO ALLOW A STRAIGHT NEEDLE TO BE INSERTED INTO THE SEPTUM WITHOUT EXCESSIVE LATERAL FORCE APPLIED TO NEEDLE CAUSING CANTING OF NEEDLE AFTER INSERTION. AIR DOES NOT PASS TO PT DUE TO PUMP'S AIR CAPTURING/ELIMINATING FEATURES. IT WAS ALSO NOTED, DURING ON-SITE INVESTIGATION, A NUMBER OF 3M MODEL 3000 INFUSION PUMP HISTORIES LOGGED A NUMBER OF AIR ALARMS. CO BELIEVES THAT DUE TO AIR-IN-LINE CAUSED BY COMBINATION OF ABBOTT LIFESHIELD NEEDLE AND GRASEBY Y-SITE, CLINICIANS WERE REMOVING AIR-IN-LINE BY OPENING AND CLOSING PUMP'S DOOR EXCESSIVELY. CO BELIVES THAT THIS ACTION CAUSED THE DIFFICULTY REPORTED BY HOSP. CO BELIEVES DIFFICULTY WITH 8C4220 ADMIN SET EXPERIENCED BY HOSP IS DUE TO EXCESSIVE AIR-IN-LINE CAUSED BY INCOMPATIBILITY OF ABBOTT LIFESHIELD NEEDLE WITH GRASEBY Y-SITE.
THE MFR OF A CONTACT LENS CARE CUP FOR USE WITH 3 PERCENT HYDROGEN PEROXIDE SYSTEMS RECEIVED A REPORT THAT A CUP BURST DURING USE. NO INJURY OCCURRED. THE MFR IS IMPLEMENTING CORRECTIVE ACTIONS TO PREVENT REOCCURRENCE OF THIS EVENT.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. THE STAPLES WERE NOT ADVANCING. THERE WAS NO CONSEQUENCE TO THE PT.
THE PHYSICIAN WAS REMOVING THE TUBE WHEN IT FRACTURED. A PIECE, APPROX 3-4 CM LONG, WAS LEFT IN THE PT'S SMALL BOWEL. A PEG TUBE WAS PLACED. PT HAD GOOD BOWEL SOUNDS AND WAS BEING OBSERVED. A SUBSEQUENT REPORT REVEALED THE TUBE WAS PLACED USING PERMANENT SUTURES INSTEAD OF DISSOLVABLE SUTURES, THUS THE TUBE HAD TO BE REMOVED SURGICALLY AND THAT IS HOW THE TUBE FRACTURED. THE REMAINING FRAGMENT WAS REMOVED SURGICALLY AS WELL. THE RPTR STATED THERE WAS NO FAULT WITH THE DEVICE. ONE PT INVOLVED.
CO'S STANDARD PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE RPTR FOR COMPLETION AND RETURN. IN THIS CASE, THE RPTR HAS NOT YET RETURNED THE FORM, THUS THE REQUIRED INFO FOR THE FOLLOWING SECTIONS IS NOT AVAILABLE AT THIS TIME: A1-A4; AND F1,F2,F6,F7,F10-F13.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PATIENT INJURY OCCURRED.
9/20/96-MEDWATC REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
INVESTIGATION CONDUCTED. DR CITES POSSIBLE EPITHELIAL CELL INVASION DUE TO PREVIOUS EXTRACTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE MFR OF A CONTACT LENS CARE CUP FOR USE WITH 3% HYDROGEN PEROXIDE SYSTEMS RECEIVED A REPORT THAT A CUP BURST DURING USE. THE MFR IS IMPLEMENTING CORRECTIVE ACTIONS TO PREVENT REOCCURENCE OF THIS EVENT.
THE LENS CUP WAS RETURNED WITHOUT A CAP AND HAD NO APPARAENT DAMAGE. THE CONCOMMITANT LENS CARE SYSTEM WAS TESTED AND PASSED NEUTRALIZATION TESTING.
THE DEVICE WAS NOT CLINICALLY APPLIED. REPORTEDLY, THE SCOPE'S VISIBILITY WAS NOT CLEAR AFTER APPROX FIFTEEN RESTERILIZATIONS.
11/5/96 - SUPPLEMENTAL REPORT SENT TO FDA. ADDITIONAL INFORMATION ENTERED IN D7, D8 AND D9. DEVICE INDICATED AND CODES ENTERED IN H3 AND H6.
DATE SENT TO FDA: 11/1/96. D1-CORRECTED INFO, D2-CORRECTED INFO, D3-CORRECTED INFO, D5-CORRECTED INFO. E1-INITIAL REPORTED WAS AN RN, WHO WAS PRESENT AT THE OCCURRENCE. CO HAS BEEN INFORMED THAT SHE IS NO LONGER WITH THIS FACILITY. F2-UF/DIST REPORT NUMBER HAS BEEN MADE ANONYMOUS HOSP RM    NOTIFIED THE MFR OF THIS OCCURRENCE ON 9/17/96, WHEN THEY WERE NOTIFIED OF THIS OCCURRENCE. F14-CORRECTED INFO. THE DATE THE MFR RECEIVED THE USER FACILITY MEDWATCH REPORT. THIS REPORT WAS FORWARDED TO THE MFR FROM THE FDA, AS AN ANONYMOUS REPORT. CO CANNOT POSITIVELY IDENTIFY THAT THE MEDWATCH AND THIS REPORT ARE THE SAME OCCURRENCE, HOWEVER, THE PRODUCT CODE, LOT # AND DATE OF THE EVENT ARE THE SAME. DATE OF THE INITIAL PHONE CONTACT BY THE USER FACILITY. AT THE TIME OF INITIAL PHONE REPORT OF THIS OCCURRENCE CO WAS INFORMED THAT THERE WAS A SAMPLE TO EVALUATE AND ARRANGEMENTS WERE MADE FOR RETRIEVAL. ON 9/17/96, WHEN RISK MANAGEMENT NOTIFIED CO BY PHONE OF THE OCCURRENCE, CO WAS INFORMED THAT THE SAMPLE WAS AVAILABLE FOR EVALUATION AND ARRANGEMENTS WERE MADE FOR RETRIEVAL. ON 10/28/96, A FOLLOW-UP PHONE CALL WAS MADE AND THE MFR WAS NOTIFIED THAT AN INDEMITY AGREEMENT WOULD NEED TO BE SIGNED IN ORDER TO RELEASE THE SAMPLE. THE MFR'S LEGAL DEPT DOES NOT AGREE TO THE STIPULATIONS MADE IN THIS AGREEMENT, THEREFORE NO SAMPLE WILL BE RELEASED. CO IS ATTACHING THIS INDEMNITY AGREEMENT, TO ILLUSTRATE THE ROADBLOCKS CO IS ENCOUNTERING WITH USER FACILITIES.
LOSS OF INTEGRATION OF 3 DENTAL IMPLANTS IN ONE PT. DR HAS BEEN ASKED FOR ADD'L INFO ON THIS EVENT.
INVESTIGATION CONDUCTED. DR CITES EARLY EXPOSURE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
A PHYSICIAN REPORTED A PT WITH A MULTIPLE TREATMENT HISTORY WHO WAS TREATED IN THE VERTICAL LINES ABOVE AND BELOW THE UPPER AND LOWER LIPS ON 10/18/96. APPROX. 6 HRS AFTER TREATMENT, THE PT DEVELOPED SWELLING OF THE TONGUE AND LOWER LIP. ON 10/19/96 THE PT CALLED THE PHYSICIAN TO REPORT THE SYMPTOMS; BENADRYL WAS PRESCRIBED. ON 10/21/96 THE PT WAS SEEN WITHOUT SYMPTOMS AT THE TREATMENT SITES AND NO SWELLING OF THE TONGUE OR LOWER LIP. THE PHYSICIAN BELIEVED THE SYMPTOMS WERE PROBABLY RELATED TO A HYPERSENSITIVITY.
FOLLOW UP WAS RECEIVED ON 5/12/97. THE PATIENT WAS LAST SEEN ON 4/28/97. NO ETIOLOGY HAD BEEN DETERMINED AND NO TREATMENT WAS REQUIRED FOR THE SYMPTOMS. SHE WAS RETESTED FOR COLLAGEN ELSEWHERE AND HAD NO REACTION; SHE WAS CLEARED. SHE RECEIVED ADDITIONAL COLLAGEN 4/28/97 WITH NO ADVERSE EFFECTS.
DURING A PTCA PROCEDURE, THE BALLOON DID NOT APPEAR TO DEFLATE. THE BALLOON WAS REMOVED PARTIALLY INFLATED. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS REVEALED A PARTIAL BLOCKAGE IN THE PROXIMAL REGION OF THE HYPOTUBE. THE REPORTED DEFLATION DIFFICULTIES WERE CONFIRMED. THE SHAFT CONDITION MAY HAVE RESTRICTED FLOW OF FLUID TO AND FROM THE BALLOON DURING THE PROCEDURE. THE BALLOON MATERIAL WAS EXAMINED AND FOUND TO BE FREE OF ANY DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE THE TISSUE. THE SURGEON USED ANTOHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/22/96- SUPPLEMENT REPORT 3 1 SUBMITTED TO FDA. ADD'L DATA ENTERED D9. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN D1 AND F.9.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
LOSS OF INTEGRATION OF TWO ENDOSSEOUS DENTAL IMPLANTS. IMPLANTS WERE 2 OF 3 PLACED. REMOVED IMPLANTS WERE PLACED IN SITES 10 AND 11 WITH RESORBABLE MEMBRANES. IMPLANTS WERE NOT RESTORED.
THE MFR WAS TELEPHONED ON 10/2/96 BY A USER FACILITY AND INFORMED THAT ONE PT HAD BEEN MIS-MEDICATED AS THE RESULT OF A USER ERROR OF ONE OF THE DEVICES MADE BY MFR. USER FACILITY REPORTED THAT NO PT INJURY RESULTED FROM THE MIS-MEDICATION. ACCORDING TO THE USAER FACILITY, A STAFF MEMBER APPLIED A TELEMETRY TRANSMITTER TO A PT AND FAILED TO FOLLOW PROCEDURE TO VERIFY THE CORRECT FREQUENCY AND ID NUMBER ACCORDING TO DEVICE LABELING. THIS ERROR RESULTED IN ONE PT'S ECG DATA BECOMING TEMPORARILY CONFUSED WITH THAT OF ANOTHER NEARBY PT. THE ERROR WAS CORRECTED BY THE USER FACILITY STAFF. FREQUENCY OF EVENT STATEMENT: THIS IS THE FIRST INSTANCE OF A CUSTOMER COMPLAINT OF THIS KIND REPORTED TO MFR. SEVERITY OF EVENT STATEMENT: MFR IS UNAWARE OF ANY RATING OR CLASSIFICATION SCALE IN WHICH TO RANK OR QUANTIFY THE SEVERITY OF A USER ERROR EVENT OF THIS KIND.
DEVICE NOT EVALUATED BY MFR SINCE PROBLEM WAS USER ERROR, AND THERE WAS NO DEFECT OR MALFUNCTION WITH THE DEVICE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.
9/19/96- A MEDWATCH REPORT WAS NOT RECEIVED BY THE MFG. INITIAL REPORT SENT TO FDA BY MFG.
AN ATTEMPT WAS MADE TO EXTERNALLY PACE A BRADYCARDIAC PT CONVERTED FROM VENTRICULAR FIBRILLATION BY DEFIBRILLATION THERAPY. ALLEGEDLY THE PACER WOULD NOT START AND INDICATED A "LEADS OFF" MESSAGE. THE PT WAS NOT RESUCITATED. THE REPORTER STATED THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THIS OPINION WAS RENDERED ON THE BASIS OF THE REPORTER'S ASSESSMENT OF THE PT'S VIABILITY.
THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. SECTION A. ALL PT RELATED INFO MADE AVAILABLE BY THE REPORTER IS INCLUDED IN THIS REPORT.
LOSS OF INTEGRATION OF 2 ENDOSSEOUS DENTAL IMPLANTS. IMPLANTS WERE 2 OF A TOTAL OF 7 PLACED. THE TWO REMOVED IMPLANTS WERE PLACED IN SITES #29 AND #30 (CLASS III BONE).
THE PUMP WAS SET TO DELIVER INSULIN AT A RATE OF 1 ML/HR. THE PUMP ALARMED "ERR N" AND 50 MLS WAS DELIVERED IN 15 MINUTES. THE PT WAS GIVEN DEXTROSE SOLUTION TO RAISE THE PTS SUGAR LEVELS BACK TO NORMAL. PT HAD STABILIZED. THE HOSP REPORTED THAT THE OVERINFUSION WAS UNRELATED TO THE PT'S DEATH.
THE PUMP WAS NOT RETURNED TO THE MFR FOR EVAL. THE PUMP WAS TESTED BY AN OUTSIDE SERVICE CENTER AND THE OVERINFUSION COULD NOT BE DUPLICATED. THE PUMP WAS REPORTED TO HAVE ALARMED "ERR N" WHICH CAN INDICATE A GUMMED-UP MECHANISM DUE TO A SOLUTION SPILL. SPILLED FLUID LEFT TO DRY MAY LEAD TO "FLO", "OCCL", OR "ERR N" ALARMS. MFR RECOMMENDS IN BOTH THE TECHNICAL SERVICE MANUAL AND THE DIRECTIONS FOR USE TO ENSURE PROPER OPERATION OF THE INSTRUMENT. THE PUMPING MECHANISM REQUIRES CLEANING AFTER FLUID SPILLS AND DURING PERIODIC INSPECTIONS. MFR'S FINAL REPORT DATE 11/22/96.
RETURNED PRODUCT ANALYSIS REVEALED THE CATHETER MET DEFLATION REQUIREMENTS. EXAMINATION ALSO REVEALED SMALL SHAFT KINKS. THE KINKS DID NOT APPEAR TO BE SEVERE ENOUGH TO BLOCK THE LUMEN DURING INFLATION AND DEFLATION. THE CAUSE OF THE SHAFT DAMAGE OR REPORTED DEFLATION DIFFICULTIES COULD NOT BE DETERMINED. NO MATERIAL OR MANUFACTURING DEFICIENCIES WERE NOTED.
THE SURGEON TESTED THE VALVE ACCORDING TO INSTRUCTIONS, AND FOUND THAT THERE WAS NO FLOW. THE RESERVOIR APPEARED TO BE OCCLUDED.
THE RETURNED PRODUCT WAS VISUALLY EXAMINED AND TESTED BY CO FOR PATENCY, REFLUX, PRESSURE/FLOW CHARACTERISTICS AND PREIMPLANTATION PRESSURE. MULTIPLE PARTICLES WERE SEEN IN THE MEMBRANE SEAT AREA OF THE VALVE. THE PRODUCT MET CO SPECIFICATIONS FOR PATENCY, REIMPLANTATION PRESSURE AND PRESSURE/FLOW AT 50.0 ML/HR (O CM HP). THE PRODUCT TESTED 0.5 CM LOW FOR PRESSURE/FLOW AT 5.0 ML/HR (O CM HP) AND DID NOT PASS THE REFLUX TEST DUE TO THE PRESENCE OF THE FOREIGN PARTICLES IN THE MEMBRANE SEAT AREA. THE ORIGIN AND COMPOSITION OF THE PARTICLES WAS UNK.
A 200 LB CONFUSED MAN WITH ALZHEIMERS DISEASE GOT HIS HEAD STUCK BETWEEN VERTICAL SLATS OF HIS BED AND GOT STRANGLED. RAIL IS SIMILAR IN STYLE TO AN INFANT CRIB, IN THAT THE RAILS ARE VERTICAL. THE VERTICAL BARS IN THIS RAIL ARE APPROX SEVEN AND ONE HALF INCHES APART. ONCE PT GOT HIS HEAD BETWEEN THE BARS, HE DID NOT HAVE THE COGNITIVE ABILITY TO FIGURE OUT HOW TO EXTRICATE HIMSELF. MUCH LIKE THE SITUATIONS THAT OCCURRED WITH INFANTS, PRIOR TO LAWS DECREASING THE SPACE BETWEENS THE BARS ON CRIBS. THE MFR STATED THAT THIS SIDERAIL HAD BEEN MFG IN THE US FOR OVER 20 YRS. HOWEVER, THE ORIGINAL PATENT HAD RUN OUT. (*)
HOSP PERSONNEL ATTENDED TO A PT DURING A CARDIOVERSION PROCEDURE. THE PT WAS ADMINISTERED 20 JOULES WHILE IN THE SYNCHRONIZED MODE. THE PT WAS NOT CONVERTED. THE DEFIBRILLATOR WAS THEN CHARGED TO 30 JOULES AND THE PT WAS ADMINISTERED THE 2ND COUNTERSHOCK IN THE NON SYNCHRONIZED MODE. REPORTEDLY THE PT WENT INTO VENTRICULAR FIBRILLATION. THE PT WAS THEN ADMINISTERED TWO MORE COUNTERSHOCKS AT 200 JOULES THEN 300 JOULES RESPECTFULLY. THE PT WAS CONVERTED. THE REPORTER INDICATED THE OPERATOR WAS NOT FAMILIAR WITH THE EQUIPMENT AND ASSUMED THE UNIT WOULD STAY IN THE SYNCHRONIZED MODE UNITL MANUALLY SWITCHED.
CO EVALUATED THE UNIT AND OBSERVED PROPER OPERATION DURING PERFORMANCE AND FUNCTIONAL TESTING. THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. SUPPLEMENTAL OPERATIONAL TRAINING WAS PROVIDED TO THE FACILITY SPECIFICALLY PERTAINING TO THE SYNCHRONIZE FUNCTION OF THE UNIT.
DURING A BOWEL PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
IMPLANT WAS EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. THE DR REPORTED THAT THE PT'S USE OF A TEMPORARY FLIPPER AND HER SMOKING HABIT MAY HAVE CONTRIBUTED TO THE LOSS OF IMPLANT. THIS IS THE SAME PT AS REPORTED IN MFR REPORT #2029012199600033.
86=DIMENSIONAL ANALYSIS, 100=THE RETURNED COMPONENT MET CO VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
CUSTOMER THEY HAVE DONE EXTENSIVE TESTING AND WRE UNABLE TO DUPLICATE INCIDENT. CUSTOMER HAS CONCLUDED EVENT CAUSED BY OPERATOR ERROR, THEREFORE, THEY HAVE ALSO COMPLETED INSERVICE TRAINING FOR ALL PERSONNEL. CUSTOMER DOES NOT WANT TO RETURN UNIT TO MFR.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. THIS CASE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS-(FROM BOX D6). MODEL/CATALOG# 3912HL/3912HL. LOT NUMBER 951072.
THE STAGED GUIDEWIRE WAS RECEIVED IN AN EXTREMELY POOR CONDITION FOR EVALUATION. VISUAL EXAMINATION REVEALED THE WIRE TO HAVE BEEN PULLED APART PRIOR TO ITS RETURN TO DATASCOPE FOR EVALUATION. THE J-TIP AREA WAS NOTED TO BE UNCOILED AND SEVERELY DAMAGED. A TRACE AMOUNT OF BLOOD WAS NOTED ON THE GUIDEWIRE TIP. PROBABLE CAUSE OF DIFFICULTY: BASED ON THE CONDITION OF THE RETURNED GUIDEWIRE, IT WAS NOT POSSIBLE TO DETERMINE THE EXACT REASON FOR THE ENCOUNTERED DIFFICULTY. ALTHOUGH CONJECTURAL, IT IS POSSIBLE THAT THE WIRE KINKED DURING INSERTION INTO THE PATIENT. THE SUBSEQUENT DAMAGE TO THE WIRE MAY HAVE OCCURRED WHEN THE WIRE WAS REMOVED. IT IS POSSIBLE THAT THE KINKED PORTION OF THE WIRE GOT "HUNG-UP" ON THE END OF THE ANGIOGRAPHIC NEEDLE DURING REMOVAL. REMOVING THE WIRE FROM THE NEEDLE MAY HAVE CAUSED IT TO BECOME SEVERELY UNCOILED.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO "MIGRATION OF THE RESERVOIR." AS REPORTED TO CO THE RESERVOIR AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
AT THIS TIME THE DEVICE HAS NOT BEEN RECEIVED AND NO ADD'L INFO HAS BEEN PROVIDED. HOWECVER, BECAUSE QA EVALUATION OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF MIGRATION, QA WILL ACCEPT THE PHYSICIAN'S DIAGNOSIS OF THIS AS THE CAUSE FOR SURGICAL INTERVENTION. IN ADDITION, BECAUSE DEVICE FUNCTION WAS NOT CITED AS A FACTOR IN THIS COMPLAINT, QA CONCLUDES THAT FUNCTION WAS NOT ASSOCIATED WITH THE CAUSE FOR REMOVAL.
THE DEVICE WAS NOT CLINICALLY APPLIED. REPORTEDLY, THE CLIPS WOULD NOT ADVANCE.
9/19/96-MEDWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
DURING A BOWEL RESECTION PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
AFTER MONITORING A PT FOR APPROX 5 MINUTES, POWER TO THE MONITOR SHUT OFF. THE OPERATOR REPLACED DEVICE BATTERIES, IN AN UNSUCCESSFUL ATTEMPT TO RESTORE MONITOR FUNCTION.
THE LOCAL FACTORY SVC REP OBSERVED THE MONITOR WOULD NOT POWER ON, DUE TO A FAILURE OF THE DEVICE POWER SUPPLY PCB ASSEMBLY. THE ASSEMBLY WAS REPLACED AND PROPER DEVICE OPERATION THEN OBSERVED, THROUGH FULL FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE. THE FACTORY OBSERVED A FAILURE OF COMPONENTS, T1 AND Q3, ON THE POWER SUPPLY PCB ASSEMBLY. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO CONTROL DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA.
DURING A PTCA PROCEDURE, THE BALLOON BURST AND A DISSECTION OCCURRED. A PERFUSION BALLOON WAS USED TO TREAT THE DISSECTION. PT WAS STABLE FOR A WHILE, BUT WAS BROUGHT BACK TO THE CATH LAB LATER WITH CHEST PAINS. A STENT WAS SUCCESSFULLY DEPLOYED TO REPAIR THE DISSECTION. PT STATUS IS LISTED AS "OK"
RETURNED PRODUCT ANALYSIS REVEALED A LONGITUDINAL BURST IN THE BALLOON WALL. THE CAUSE OF THE BALLOON BURST COULD NOT BE DETERMINED. NO MATERIAL OR MANUFACTURING DEFICIENCIES WERE NOTED.
THE MFR OF A CONTACT LENS CARE CUP FOR USE WITH 3% HYDROGEN PEROXIDE SYSTEMS RECEIVED REPORT FROM A FEMALE PT THAT A CUP BURST DURING USE. NO INJURY OCCURRED. THE MFR IS IMPLEMENTING CORRECTIVE ACTIONS TO PREVENT REOCCURRENCE OF THIS EVENT.
DECISION MADE TO REMOVE PT FROM VENTLATOR. PLACED ON 100% BLOW-BY VIA HUMIDIFIED BLOW-BY SET UP WITHOUT "T-PIECE" OR EXHALE PORT. PT IMMEDIATELY SHOWED SINUS BRADYCARDIA TO ASYSTOLE. PT WITH INCREASED FACIAL AND BODY SWELLING (1G AMNT SUB-Q) AIR. THE BLOWBY WAS SETUP AND INTERFACED WITH THE PT SO THE PT COULD NOT EXHALE THROUGH THE CIRCUITRY.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. PT IS A "HEAVY" SMOKER. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE SAFETY SHIELD WOULD NOT RETRACT WHEN APPLIED TO TISSUE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/19/96- METWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
PORT CLOTTED DURING IMPLANTATION. ANOTHER PORT HAD TO BE IMPLANTED.
1. NO FURTHER INFO IS AVAILABLE AS OF 10/22/96. 2. HOSPITAL HAS STATED THAT DURING IS BEING RETURNED (UPN DECONTAMINATION) FOR EVALUATION.
THE CUSTOMER SENT A MEDWATCH THAT INDICATED "THE BOVIE SOUND DID NOT ALERT THE TREATING PHYSICIAN THAT HE HAD ACTIVATED THE MACHINE BY PRESSING ON THE FOOT PEDAL. CONSEQUENTLY, THE POSTERIOR VAGINAL WALL WAS BURNED. A SURGEON RESECTED THE BURN AREA TO SPEED HEALING AND TO AVOID THE DEVELOPMENT OF A VAGINAL-RECTAL FISTULA.
THE CUSTOMER WAS CONTACTED AND DID NOT WISH TO RETURN THE GENERATOR. THE GENERATOR IS BELIEVED TO BE WORKING CORRECTLY BECAUSE OTHER O.R. PERSONNEL WERE ABLE TO HEAR THE ACTIVATION TONE WHEN THE SURGEON INDICATED HE COULD NOT. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PRIVELEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
A BALLOON RUPTURED ON THE FIRST INFLATION AT SEVEN ATMOSPHERES DURING A PRE-DILATATION OF THE ILIAC ARTERY PRIOR TO STENT PLACEMENT. ANOTHER BALLOON CATHETER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY., THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. IT WAS INDICATED THIS DEVICE WAS USED TO DILATE A LESION PRIOR TO STENT PLACEMENT. STENT PLACEMENT MAY BE INDICATED WHEN IT IS BELIEVED ANGIOPLASTY ALONE WILL NOT ACHIEVE A GOOD RESULT. CO BELIEVES THE NATURE OF THE LESION CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE PRODUCT, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
INFO SUPLLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
PARAMEDICS WERE ATTENDING TO A PT IN A CODE SITUATION, CONDITION UNK. AN ATTEMPT TO SHOCK THE PT WAS MADE AND ALLEGEDLY THE OPERATOR COULD NOT SELECT ENERGY OVER 200 JOULES. THE PT WAS TRANSPORTED TO THE HOSP.
CO IS CURRENTLY INVESTIGATING THE ALLEGED EVENT. CO WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. SECTION A. ALL PT RELATED INFO MADE AVAILABLE BY THE REPORTER IS INCLUDED IN THIS REPORT. F10. CODE #2202 LABELING NA.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PATIENT INJURY OCCURRED.
THE MFR OF A CONTACT LENS CARE CUP FOR USE WITH 3% HYDROGEN PEROXIDE SYSTEMS RECEIVED A REPORT THAT A CUP BURST DURING USE. NO INJURY OCCURRED. THE MFR IS IMPLEMENTING CORRECTIVE ACTIONS TO PREVENT REOCCURRENCE OF THIS EVENT.
PT WITH SEVERE BILATERAL PNEUMONIA ATTEMPTING STABILIZATION FOR AIR TRANSPORT TO ANOTHER FACILITY. PT INTUBATED ON VENT. TRANSPORT TEAM REQUESTED CHANGES IN VENT SETTINGS FROM ASSIST CONTROL MODE TO PRESSURE CONTROLLED VENTILATION. DUE TO SLOW VENTILATOR PROGRAMMING TIME, THE PT WAS REMOVED FROM VENTILATOR AND MANUAL BAGGING WAS BEGUN. DURING MANUAL BAG VENTILATIONS, PT DEVELOPED CARDIO-PULMONARY ARREST AND SUBSEQUENTLY EXPIRED. VENTILATOR SCREEN INDICATES "PENDING". ACTUAL PROBLEM WAS OPERATION OF VENT NOT SCROLLING TO "START" TO ACTIVATE PC MODE. AGE OF DEVICE 5,981.3 HRS.
THE PT'S ARTERY WAS CUT DOWN, AND THE DR TRIED TO INSERT AN IAB SHEATHLESS THROUGH THE PT'S OPEN FEMORAL ARTERY. HE WAS NOT ABLE TO SO A SHEATH WAS USED WITHOUT ANY FURTHER PROBLEMS.
PT ON HUNTING TRIP DIED. TAKEN TO ER AND WAS DEAD ON ARRIVAL. BODY SENT FOR AUTOPSY. SUSPECT NON-FUNCTIONING OR MALFUNCTIONING PACEMAKER CONTRIBUTED OR CAUSED DEATH. PACEMAKER IMPLANT 8/6/96. ON 9/23/96 VENTRICULAR LEAD EXPLANTED AND REPLACED WITH ANOTHER.
CO EVALUATED THE DEVICE WITH ATTACHED MODULE FOR USE WITH THE DEFIB/PACEMAKER AND OBSERVED PROPER OPERATION, THROUGH FULL PERFORMANCE AND FUNCTIONAL TESTING. THE FACILITY WAS PROVIDED WITH A NEW DEVICE OF THE SAME MODEL BY CO. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
REPORTEDLY, THE DEVICE DID NOT DISCHARGE ENERGY TO A PT WHEN THE DEFIBRILLATOR DISCHARGE BUTTONS WERE PRESSED, AND ON THE NEXT ATTEMPT THE DEVICE AUTO-DISCHARGED ENERGY TO THE PT.
A 44-YR-OLD PT UNDERWENT CRANIOTOMY TO REMOVE 4CM TUMOR. VENTRICULAR CATH PLACED AND ATTACHED TO DRAINAGE SYSTEM. STOP COCK AND CLAMPS OPENED IN RECOVERY ROOM, TO DEPENDANT DRAINAGE WITH 100CC OUTPUT. TRANSFER TO ICU - NEUROLOGICALLY RESPONSIVE, ALERT, COOPERATIVE X 7.5 HRS. ABRUPTLY BECAME OBTUNDED. WHILE IN THE RADIOLOGY DEPT THE CLAMP ON THE DRIP CHAMBER VENT WAS DISCOVERED TO BE CLOSED. PT IS NOT EXPECTED TO RECOVER - BRAIN DEATH TO BE DOCUMENTED. RISK MGR UNABLE TO DETERMINE WHO/HOW CLAMP WAS CLOSED. NURSES REQUEST PRODUCT CHANGE TO MAKE VENT CLAMP A DIFFERENT COLOR.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. WHEN THE BLADES ARE OPENED, THE BLOCK SLEEVE HAS BEEN SLITTED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFO NOT SUPPLIED BY AFFILIATE. D5,6;H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
PT HAVING A TOTAL HIP PROSTHESIS. 5 MINS AFTER CEMENT APPLICATION, (METHYL METHACRYLATE) PT WENT INTO ASYSTOLE, WAS INTUBATED AND CODED UNSUCCESSFULLY.
AFTER IABP FOR 1 HOUR, THE IAB LEAKED. WHEN THE IAB WAS REMOVED, THE INNER LUMEN WAS BROKEN THE IAB WAS NOT RETURNED TO CO FOR EVAL. THE IAB WAS DISCARDED BY THE FACILITY.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738 EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY HOSP.
THE REFLECTOR LIGHT FELL ON TO THE EXAM TABLE.
THE INVESTIGATION DETERMINED THAT THE SINGLE SCREW AND NOT HOLDING THE HEAD ASSEMBLY TOGETHER SEPARATED. A PRIOR INVESTIGATION YIELDED THAT THE SCREW CAN LOOSEN DURING USE ON RARE OCCASIONS. A CHANGE OF MFG COMPONENTS AND TECHNIQUES WERE IMPLEMENTED TO ELIMINATE ANY FUTURE OCCURRENCES OF THIS EVENT. THERE ARE NO PT CODES APPLICABLE TO THIS EVENT SINCE THERE WERE NO INJURIES.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLESCYSTECTOMY. IT WAS REPORTED BY THE REP. THERE WAS GAS LEAKAGE BECAUSE OF DROPPING SILICON RING OF FLAPPER BULB. THE RING WAS RETRIEVED FROM THE ABDOMEN AND A NEW TROCAR WAS USED WITHOUT DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B6,7,D10-INFORMATION NOT PROVIDED BY AFFILIATE.H4,D5,6-INFORMATION NOT AVAILABLE.BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THA THE INSTRUMENT HAD BECOME "CRACKED" DURING SURGERY. THE SLEEVE WAS RECEIVED WITH THE SHATTERED PIECES OF THE DISTAL TIP TAPED TOGETHER. A 1/4" X 1/2" PIECE OF THE TIP WAS NOT RECEIVED WITH THE INSTRUMENT. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. WE STRIVE TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS. APPROPRIATE ENGINEERING AND MFG PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.
REPORT OF ALLEGED "SINGLE TONE ALARM, ALL LEDS ON, UNIT STOPPED CYCLE. NO PT HARM".
H6) 100-REPORTED FAILURE DUE TO LIQUID SPILL. 68-REPORTED FAILURE DUE TO LIQUID SPILL. TESTING BY MFR FOUND DEVICE WOULD NOT CYCLE, WITH ALL LEDS AND A CONSTANT SINGLE TONE ALARM, DUE TO LIQUID SPILL ON LOGIC AND MOTOR BOARDS.
THE DEVICE WAS APPLIED DURING A HERNIA PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY.
10/3/96-SUBMISSION OF SUPPLEMENTAL REPORT WITH ADD'L INFO ENTERED IN THE FOLLOWING AREAS: D-7,D-8,D-9,G-4,H-3 AND H-6.
DURING A BOWEL RESECTION PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCDDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
ON 9/30 A FACILITY REPORTED THAT A PT HAD LOST AN EXCESS OF 3.6 KG. OF FLUID DURING A DIALYSIS TREATMENT ON 9/10. THE PT HAD BECOME HYPOTENSIVE, RECEIVED NORMAL SALINE AND THE ULTRAFILTRATION TURNED OFF. THE TREATMENT WAS COMPLETED. THE MACHINE WAS REMOVED FROM THE TREATMENT AREA FOR SERVICE BY THE FACILITY MACHINE TECHNICIAN. UPON INSPECTION OF THE MACHINE, HE FOUND A VALVE NOT FUNCTIONING PROPERLY. TWO DIFFERENT VALVES WERE REPLACED AND HE VERIFIED THE MACHINE WAS OPERATING PROPERLY. THE VALVES WERE DISCARDED. THE MACHINE WAS RETURNED TO THE TREATMENT AREA AND HAS BEEN OPERATING WITHOUT PROBLEMS SINCE REPAIR.
THE MFR OF A CONTACT LENS CARE CUP FOR USE WITH 3% HYDROGEN PEROXIDE DISINFECTION SYSTEMS RECEIVED NOTIFICATION THAT A CUP BURST DURING USE. NO INJURY OCCURRED. THE MFR HAS REQUESTED THE COMPLAINT CUP AND IS IMPLEMENTING CORRECTIVE ACTIONS TO PREVENT REOCCURRENCE OF THIS EVENT.
REPORT OF ALLEGED "SINGLE TONE ALARM, ALL LEDS ON STOP CYCLE. NO PT HARM".
TESTING BY MFR WAS DEVICE FULLY FUNCTIONAL.
PARAMEDICS WERE ATTENDING TO A PT IN FULL CARDIAC ARREST, EXHIBITING VENTRICULAR FIBRILLATION. THE PT WAS COUNTERSHOCKED ONCE AT 200 JOULES. ALLEGEDLY AS A SECOND ATTEMPT WAS MADE TO COUNTERSHOCK, THE OPERATOR REPORTEDLY COULD NOT ADVANCE THE ENERGY SELECTION TO 300 JOULES. THE BATTERY WAS CHANGED WITH SAME RESULT. THE THERAPY MODULE WAS REMOVED AND REATTACHED AND THE DEVICE FUNCTIONED PROPERLY FOR THE REMAINDER OF THE CODE. THE PT WAS RESUSCITATED. THE FOLLOWING EVENING THE DEVICE WAS TESTED AND ALLEGEDLY DISPLAYED ARTIFACT RESEMBLING VENTRICULAR FIBRILLATION.
CO EXAMINED THE DEVICE AND OBSERVED PROPER OPERATION. THE PATIENT MONITORING CABLE WAS EXAMINED AND IT WAS OBSERVED THE RL LEAD WIRE WOULD SHORT TO THE SHIELDING WHEN FLEXED AT THE CONNECTOR. THE MONITOR AND THE MONITORING CABLE WERE NOT RETURNED TO THE CUSTOMER BUT WERE REPLACED WITH A NEW UNIT TO ENHANCE THE CUSTOMER'S CONFIDENCE.
A BALLOON RUPRUTED ON THE FIRST INFLATION AT SIX ATMOSPHERES DURING AN ILIAC ANGIOPLASTY OF A CALCIFIED LESION VIA AN IPSILATERAL APPROATHC, ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATONS. TGHE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH AS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. SINCE FOLLOW UP INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION, CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON, THESE BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURED DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEUDRE. DEFLATE THE BALLOON. DI NOT REINFLATE AND REMOVE CAREFULLY."
INFO SUPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISASION OF THIS MEDWATCH REPORT TO THE FDA.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT WOULD NOT OPEN. THE SURGEON MANUALLY MANIPULATED THE DEVICE FREE FROM TISSUE WITHOUT INJURY TO THE PT.
THE MFR OF A CONTACT LENS CUP FOR USE WITH 3% HYDROGEN PEROXIDE DISINFECTION SYSTEMS RECEIVED A REPORT THAT A CUP BURST DURING USE. NO INJURY OCCURRED. THE MFR IS IMPLEMENTING CORRECTIVE ACTIONS TO PREVENT REOCCURRENCE OF THIS EVENT.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
THE "GAS LOSS" ALARM SOUNDED FROM THE PUMP. BLOOD WAS NOTED IN THE TUBING APPROX. THREE HOURS AFTER THE "GAS LEAK" ALARM SOUNDED. THE IAB WAS REMOVED AND A SECOND WAS INSERTED INTO THE PATIENT WITHOUT A PROBLEM. ON 10/31/96, DATASCOPE WAS NOTIFIED THAT THE PATIENT EXPIRED ON 9/28/96 AT 12:20 AFTER DNR AND WITHDRAWAL OF SUPPORTS (VENT, IABP, MEDS). EVENT COMPLICATIONS: UNK - REPORTED 10/2/96; NONE - REPORTED 10/31/96. PATIENT'S CURRENT STATUS: EXPIRED - RPT'D 10/31/96.
THE DEVICE WAS APPLIED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT HOLD. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/20/96 - MEDWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT DID NOT FIRE PROPERLY. THE HOSP DID NOT PROVIDE ANY FURTHER INFO.
THE GENERATOR WAS RETURNED TO CO'S SERVICE DEPARTMENT FOR SERVICING AND FOUND TO HAVE DUAL ACTIVATION FROM THE HANDSWITCH AND FOOTSWITCH. THE CUSTOMER WAS CONTACTED AND NO PT OR PERSONAL INJURY OCCURRED.
THE GENERATOR WAS CONFIRMED TO HAVE OUTPUT POWER FROM THE ACCESSORY JACK WHEN THE UNIT WAS KEYED FROM THE HANDSWITCHING JACK. THIS CONDITION WAS CAUSED BY A COMPONENT FAILURE OF RELAY, K01 ON THE STRIPLINE BOARD. THIS IS CONSIDERED AN ISOLATED COMPONENT FAILURE. THE INFORMATION CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFORMATION SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
PHYSICIAN OBSERVED SHIELD DID NOT DISSOLVE AFTER 24 HRS AND IT FOLDED OVER ITSELF, BECAME HARD AND ABRAIDED THE CORNEAL. THIS EVENT RESOLVED AFTER 3 DAYS AND WAS TREATED WITH PRESSURES PATCHING. HE REPORTS HE ROUTINELY SOAKS THE SHIELD IN ANCEF AND SOLUMEDROL.
THIS REPORT WAS ORIGINALLY RECEIVED BY THE MFR ON 8/15/96. ADD'L INFO WAS RECEIVED ON 10/3/96 FROM THE PHYSICIAN WHO REPORTED A MALFUNCTION WITH THE POTENTIAL FOR SERIOUS INJURY. THE RETURNED UNOPENED PRODUCTS WERE SUBJECTED TO IN-VITRO DISSOLUTION TESTING. DISSOLUTION TIMES WERE LONGER THAN PREVIOUSLY SEEN FOR THIS PRODUCT AGE. THE LONGER DISSOLUTION TIME IS BELIEVED TO BE RELATED TO MANUFACTURING PROCESS CHANGES EARLY IN 1996. AS A RESULT OF THESE COMPLAINTS, WE HAVE CHANGED BACK TO THE PREVIOUS PROCESS. INFO SUPPLIED IN SECTION F HAS BEEN PROVIDED BY THE MFR, NOT THE USER FACILITY. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING RQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE DEVICE WAS APPLIED DURING A THORACIC WEDGE RESECTION. REPORTEDLY, THE INSTRUMENT DID NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
THE DEFIBRILLATOR WOULD NOT CHARGE FOR A PT DIAGNOSED IN VENTRICULAR FIBRILLATION.
THE CO SVC REP OBSERVED PROPER DEVICE OPERATION AND RETURNED THE DEVICE TO USE. THE REPORTER STATED THAT AN INVESTIGATION INTO THE EVENT INDICATED THE REPORT WAS LIKELY THE RESULT OF OPERATOR ERROR. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA.
ON 9/13/96 CO RECEIVED A COMPLAINT CONCERNING ONE OF THESE DEVICES, MODEL NUMBER 2608-03 PORT. COMPLAINT ALLEGEDLY REPORTS THAT THE DEVICE IS LEAKING.
PRODUCT WAS RETURNED 9/17/96 FOR EVALUATION.
DURING AN UNSPECIFIED THORACOSSCOPIC PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/1/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE MFR OF A CONTACT LENS CARE CUP FOR USE WITH 3% HYDROGEN PEROXIDE SYSTEMS RECEIVED A REPORT THAT A CUP BURST DURING USE. NO INJURY OCCURRED. THE MFR IS IMPLEMENTING ACTIONS TO PREVENT REOCCURRENCE OF THIS EVENT.
THE CUSTOMER REPORTED THAT THEY WOULD NOT USE THIS PENCIL BECAUSE "PART OF THE BLUE CORD IS SEALED UP IN THE BLUE".
THE RETURNED PENCIL WAS FOUND TO HAVE THE CORD INSULATION SMASHED IN THE BODY WELD DUE TO A MISALIGNMENT OF THE PENCIL BODY DURING THE MFG PROCESS. THE PENCIL FAILED HIGH VOLTAGE WITHSTAND TESTING. THIS IS AN ISOLATED OCCURRENCE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATION RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFORMATION SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
A BALLOON DEVELOPED A PIN-HOLE LEAK ON SECOND INFLATION DURING AN ARTERIOVENOUS HEMODIALYSIS FISTULA GRAFT DILATATON. NO ADD'L DILATATIONS WERE NECESSARY AND PROCEDURE WAS COMPLETED SUCCESSFULLY AT THAT TIME. DEVICE HAS BEEN DESTROYED BY USER FACILITY. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. BALLOON RUPTURE OF BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSSURIZATION OR USE IN A CALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. IT WAS ALSO INDICATE THIS DEVICE WAS INFLATED WITHOUT THE BENEFIT OF A PRESSURE GAUGE. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTION FOR USE STATE: "IT IS ESSENTIAL THAT AN INFLATION DEVICE WITH A PRESSURE GAUGE BE USED TO MONITOR PRESSURE WITHIN THE BALLOON TO DETERMINE THE ADEQUATE DILATING FORCE IS APPLIED WHILE NOT EXCEEDING THE MAXIMUM LIMITS OF THE PRODUCT. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
THE DEVICE WAS APPLIED DURING A RADICAL PROSTECTOMY PROCEDURE. REPORTEDLY, THE NEEDLE BROKE. THE BROKEN COMPONENT WAS NOT RETRIEVED. THE HOSPITAL HAS REPORTED THAT THE PT STATUS IS SATISFACTORY.
DURING A GASTRO-PLASTIC SURGERY. THE CARTRIDGE BROKE AND SEVERAL COMPONENTS DISENGAGED INTO THE PT'S CAVITY. THE SURGEON RETRIEVED ALL OF THE COMPONENTS WITHOUT INCIDENT.
FIRE DEPT PERSONNEL WERE ATTENDING TO A PT, CONDITION UNK. AS THE DEFIBRILLATOR BEGAN TO CHARGE, THE DISPLAY FLASHED AN UNSPECIFIED "SVC  MANDATORY" MESSAGE WOULD NOT COMPLETE THE CHARGE CYCLE. A BACK UP DEVICE WAS PRESENT SO THE PT WAS IMMEDIATELY SWITCHED OVER AND TREATMENT CONTINUED. THE PT WAS SUCCESSFULLY RESUSCITATED.
THE DEVICE HAS BEEN RETURNED TO THE CUSTOMER FOR USE. SECTION A. ALL PT RELATED INFO MADE AVAILABLE BY THE REPORTER HAS BEEN INCLUDED IN THIS REPORT. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO CONTROL DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA.
ON 9/17/96 CO RECEIVED A COMPLAINT CONCERNING ONE OF THEIR DEVICES, MODEL #3608-03 PORT. COMPLAINT ALLEGDLY REPORTS THE DEVICE TO BE LEAKING.
PRODUCT WAS RETURNED 9/25/96 FOR EVAL. EVALUATION VERIFIED PORT DID HAVE A LEAKING MALFUNCTION. HISTORY OF OCCURRENCE: FREQUENCY OF OCCURRENCE = .010 INCINDENCE REPORTS UNITS DISTRIBUTED LOW. SEVERITY OF OCCURRENCE = 5 PTS INVOLVED, 7 TOTAL INCIDENCE REPORTS=71% HIGH.
EITHER THE DEVICE STOPPED PACING OR PACING COULD NOT BE INITIATED DURING PT USE.
THE CO'S SVC REP OBSERVED PROPER DEVICE OPERATION. THE REPORTER EXPRESSED THE OPINION THAT THE REPORT WAS POSSIBLY THE RESULT OF OPERATOR ERROR. THE REPORTER WILL REVIEW DEVICE PACER OPERATION WITH THE FACILITY STAFF. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA.
NEEDLE BREAKAGE SURGEON UPON FINISHING C-SECTION, DROPPED SUTURE AND NEEDLE ON FLOOR AT WHICH TIME IT WAS OBSERVED THAT NEEDLE TIP HAD BROKEN. X-RAYS SHOWED NO NEEDLE TIP LEFT IN PT. OUTCOME TO PT DOES NOT DENOTE ADVERSE EVENT. MDR REGULATIONS 7/31/96 REQUIRE REPORTING OF INCIDENTS ONCE MEDICAL DEVICE FAMILY INITIALLY REPORTED ASSUMING INCIDENT COULD RECUR.
H6- THE FIVE NEEDLES FROM THE UNOPENED PACKETS RETURNED WERE VISUALLY EXAMINED AND THEN TESTED WERE VISUALLY EXAMINED AND THEN TESTED FOR STRENGTH AND DUCTILITY. ZERO VISUAL NONCONFORMANCE WERE OBSERVED AND EACH NEEDLE MET THE ETHICON REQUIREMENTS FOR STRENGTH AND DUCTILITY. A PRODUCT INQUIRY RECORDS REVIEW WAS ALSO CONDUCTED AND THERE HAVE BEEN NO OTHER INQUIRIES OF ANY TYPE RECEIVED INVOLVING THIS BATCH NUMBER.
DURING PT TRANSPORT TO THE ICU WHILE THE PT WAS BEING MANUALLY VENTILATED USING AN AMBU BAG, THE REAR ASSEMBLY THAT CONNECTS TO O2 RESERVOIR SEPARATED FROM THE BAG. THE EVENT WAS NOT REPORTED TO HAVE ANY INFLUENCE ON THE SITUATION OF PT.
THIS REPORT IS SUBMITTED IN ACCORDANCE WITH PART 803 OF FDA REGULATIONS AND SHOULD NOT BE CONSTRUED AS AN ADMISSION BY CO OF THE ACCURACY OF THE STATEMENTS INCLUDED IN IT OR OF THE CAUSAL RELATIONSHIP BETWEEN THE USE OF THE PRODUCT AND THE INJURY DESCRIBED. EVAL SUMMARY: RETURNED DEVICES FROM THE SAME LOT WERE EVALUATED. THEY ALL WERE ASSEMBLED CORRECTLY AND PERFORMED ACCORDING TO SPECIFICATION. THERE WERE NO DEFECTS ON THE PRODUCTS. THE REPORTED SITUATION COULD OCCUR ONLY IF THE BAG HAS BEEN MISASSEMBLED. SHOULD THIS HAPPEN THE SITUATION WOULD BE IMMEDIATELY RECOGNIZABLE TO THE USER, THUS PREVENTING ANY ADVERSE EFFECT ON THE PT. REVIEW OF CO PRODUCTION RECORDS FROM THE LOT INVOLVED CONFIRMED ALL QUALITY INSPECTIONS INCLUDING CHECK OF PROPER ASSEMBLY HAVE TAKEN PLACE ACCORDING TO DEFINED PROCEDURES PRIOR TO RELEASE OF THE ACTUAL LOT.
THE AUS DEVICE WAS REMOVED FROM THE PT BECAUSE OF RECRUURING INCONTINENCE DUE TO CUFF EROSION.
THE DEVICE ANALYZED THE PT ECG AND RENDERED A DECISION TO SHOCK. REPORTEDLY, THE DEVICE POWER SHUT OFF DURING THE DEFIBRILLATOR CHARGE.
THE LOCAL FACTORY SVC REP INSTALLED THE BATTERY WHICH WAS IN USE INTO THE REPORTED DEVICE. A "NEEDS SVC/BATTERY LOW" MESSAGE WAS OBSERVED DURING THE DEFIBRILLATOR CHARGE. ANOTHER BATTERY WAS INSTALLED INTO THE DEVICE AND PROPER OPERATION THEN OBSERVED, THROUGH FULL FUNCTIONAL AND PERFORMANCE TESTING. THE DATE CODE LABEL FOR THE DISCREPANT BATTERY WAS MISSING AND LOST, BUT IT WAS DETERMINED TO HAVE BEEN IN USE FOR APPROX TWO YEARS. THE REP PROVIDED THE FACILITY WITH ADD'L BATTERY MAINTENANCE TRAINING AND TRAINING MATERIALS. THE FACILITY HAS ELECTED TO RETAIN THE BATTERY. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUBMIT ADD'L INFO ON THIS EVENT TO FDA.
THE INSTRUMENT WAS USED DURING A BOWEL RESECTION. WHEN FIRING THE INSTRUMENT, STAPLES DID NOT FORM. HEMOSTASIS WAS NOT ACHIEVED. SURGEON HAD TO USE A SECOND STAPLER TO ACHIEVE HEMOSTASIS. THERE WAS NO CONSEQUENCE TO THE PT.
10/10/96 1105 MADE NUMEROUS ATTEMPTS TO REACH SURGEON BUT PHONE BUSY. WILL TRY LATER. 10/10/96 1115 NO ANSWER AT GIVEN NUMBER AFTER MORE THAN 15 RINGS. 10/10/96 1215 MADE SEVERAL MORE ATTEMPTS AND NUMBER GIVEN PHONE BUSY AT BOTH LOCATIONS. 10/11/96 0905 DR IS OUT UNTIL 10/21/96. WILL SEND NNCL. 10/13/96 NNCL SENT. A1,2,3,4; B6,7; D10; E3; INFO UNAVAILABLE. BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS FIRED WITH A RELOAD CARTRIDGE AND FIRED AND FORMED STAPLES AS DESIGNED ACROSS THE ENTIRE STAPLE LINE. ADDITIONALLY, THE STAPLE HEIGHTS WERE MEASURED AND FOUND TO BE CONFORMING WITH RESPECT TO MANUFACTURING REQUIREMENTS. THEREFORE, IT COULD NOT BE ASCERTAINED AS TO WHY THE STAPLES REPORTEDLY MALFORMED. MANUFACTURING AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
ON 6/8/96 PT SLIPPED AND INJURED HER LEFT HIP. ADMITTED TO HOSP ON 6/18/96 FOR SUBTROCHANTERIC FRACTURE OF LEFT HIP. IMPLANTED WITH HIP SCREW AND SIDE PLATE, 8 HOLE. ON 8/20/96 X-RAYS TAKEN SHOWED SIDE PLATE TO BE BROKEN. ON 8/21/96 SIDE PLATE REMOVED AND REPLACED WITH A IM ROD.
INVESTIGATION OF THE REFERENCED COMPLAINT HAS BEEN COMPLETED. THE COMPLAINT ON THE DEVICE STATING THAT "THE PENCILS ARE STICKING IN THE ON POSITION." WAS RECEIVED 106 AND A MALFUNCTION MDR WAS FILED BASED ON THE INFO PROVIDED THAT NO INJURY OCCURRED HOWEVER REOCCURRENCE MAY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THE DEVICE WAS NOT RETURNED FOR EVALUATION BY CO. DEVICES TESTED FROM SIMILAR LOTS OPERATED NORMALLY WITH NO STICKING OF THE SWITCHES OBSERVED. THE PENCIL CONFIGURATION WAS EXAMINED THROUGHOUT THE SWITCHCORE AREA AND THERE WAS NO EVIDENCE THAT INDICATED HOW THE SWITCHES COULD BECOME STUCK ON OR REMAIN ACTIVE FROM ANY OTHER IDENTIFIED MALFUNCTION TYPE. THE PENCIL WAS FROM A LOT MANUFACTURED IN 5/96 AND THIS CONFIGURATION DEVICE HAS HAD NO OTHER REPORTS OF STICKING. CO REGRETS THAT THE INCIDENT OCCURRED, ALTHOUGH SINCE NO DEVICE WAS AVAILABLE FOR EVAL, NO CAUSE FOR THE STICKING ON COULD BE IDENTIFIED WITH THIS CONFIGURATION. THE USER IS REMINDED THAT TO PREVENT INJURY FROM ACCIDENTAL ACTIVATIONS, GOOD ELECTROSURGERY  PRACTICE REQUIRES THAT ACTIVE ACCESSORIES BE STORED IN THE SAFETY HOLSTER PROVIDED WHEN THEY ARE NOT IN USE.
THE DR WAS UNABLE TO INSERT THE IAB INTO THE HEMOSTASIS VALVE. THE IAB WAS NOT RETURNED TO CO FOR EVAL. THE IAB WAS DISCARDED BY THE FACILITY.
EMT'S RESPONDED TO A PERSON DESCRIBED AS IN CARDIAC ARREST. CPR AND AN UNK NUMBER OF COUNTERSHOCKS FROM THE DEVICE WERE ADMINISTERED. THE DEVICE ADVISED A SHOCK ON WHAT WAS REPORTED TO BE AN ORGANIZED, NON-SHOCKABLE CARDIAC RHYTHM AND NO SHOCK WAS DELIVERED BY THE OPERATOR. THE PT WAS RESUSCITATED.
IN AN EVALUATION OF THE DEVICE'S CASSETTE TAPE EVENT RECORDED, GIVEN THE INFORMATION PRESENTED TO THE DEVICE, IT OPERATED AS DESIGNED.
THE TLC75 WAS USED DURING A COLON RESECTION. WHILE TRANSECTING THE BOWEL WITH THE DEVICE, THE STAPLE LINES APPEARED INCOMPLETE WITH STAPLES MISSING INTERMITTENTLY ON BOTH SIDES OF THE CUT LINE. THIS RESULTED IN THE LEAKAGE OF FECAL MATTER FROM BOTH ENDS OF THE BOWEL INTO THE PT'S PERITONEAL CAVITY. THE DIRECTOR OF SAFETY FIRED THE DEVICE WITH A FRESH CARTRIDGE AND IT WORKED FINE. THE INSTRUMENT IS BEING RETURNED WITH THE ORIGINAL RELOAD. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6; H3,4,6;G4: ADDED ADDITIONAL INFO. D6: DEVICE RETURNED WITH NO ID. CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT COULD NOT BE DETERMINED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH HISTORY RECORDS FOR THE INSTRUMENT AND CARTRIDGE WERE INVESTIGATED AND THERE WERE NO ANOMOLIES NOTED FOR MISSING STAPLES. IT SHOULD BE NOTED THAT DURING MFG, ALL THE CARTRIDGES ARE 100% INSPECTED TO ENSURE THAT ALL STAPLES ARE PRESENT PRIOR TO SHIPMENT. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
REPORT FROM DISTRIBUTOR INDICATED THAT USER ENCOUNTERED DIFFICULTY IN REMOVING PROTECTIVE LINER. PADS PEELED APART WHEN USER WAS UNABLE TO REMOVE LINER.
THE CRACKING OF THE OUTER INSULATION WAS THE RESULT OF ENVIRONMENTAL STRESS CRACKING. THE STRESS WAS PROVIDED BY THE BENDING OF THE LEAD NEAR THE CONNECTOR AS A RESULT OF THE LEAD DRESSING IN THE POCKET.
A FILTER DID NOT OPEN AFTER DEPLOYNMENT VIA A FEMORAL APPROACH. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO MANIPULATE THE FILTER WITH A GUIDEWIRE. A SECOND FILTER WAS PLACED WITH NO PT COMPLICATIONS. THIS DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. IT WAS INDICATED A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO FILTER PLACEMENT AND CONTINUAL FLUSHING OF THE CARRIER SYSTEM DURING THE IMPLANT PROCEDURE WAS NOT PERFORMED WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "AN INFERIOR VENA CAVOGRAM MUST BE PERFORMED PRIOR TO VENA CAVA FILTER INSERTION. THIS PROCEDURE DETERMINES CAVAL  PATENCY AND DIAMETER AND IS USED TO EVALUATE THE INFERIOR VENA CAVA FOR THE PRESENCE OF THROMBUS AND CONGENITAL ANOMALIES. DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER. IN MOST CASES. A SECOND FILTER, PROERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE. THE INTRODUCER CATHETER MUST BE FLUSHED THROUGH THE FLUSH PORT BY FREQUENT INJECTION OR CONTINUOUS INFUSION OF STERILE HEPARINIZED SALINE DURING THE IMPLANT PROCEDURE. INSUFFICIENT FLUSHING CAN ALLOW THROMBUS FORMATION INSIDE THE VENA CAVA FILTER WHICH CAN BIND THE LEGS AND PREVENT COMPLETE OPENING UPON RELEASE."
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SIUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
A LEAD INSULATION FRACTURE WAS OBSERVED.
THE BREACH OF THE OUTER INSULATION NEAR THE CONNECTOR BOOT WAS THE RESULT OF ENVIRONMENTAL STRESS CRACKING. THE STRESS WAS PROVIDED BY BENDING OF THE LEAD IMPOSED BY THE GEOMETRY OF THE POCKET DRESSING.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WOULD NOT ADVANCE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. THE CARTRIDGE DISENGAGED PRIOR TO FIRING. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
H6; EVALUATION CODE #400(OTHER): YEILDED JAWS. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
DEVICE WAS RETURNED. IS NOT ON FILE FOR TEXT COPY.  ENTER TEXT.
PT WAS USING THE DEVICE WHEN THE SYRINGE PIPE BROKE OFF AND BECAME LODGED IN THE RECTUM. THE PT WAS TRANSPORTED TO THE HOSP FOR REMOVAL. THE PT WAS X-RAYED TO LOCATE THE PIPE. IT WAS REMOVED NONSURGICALLY, AND THE PT WAS SENT HOME THAT DAY. PT IS DOING FINE. THERE WAS NO ILLNESS, INJURY OR MEDICAL INTERVENTION RESULTING FROM THE EVENT. ONE PT INVOLVED.
CO'S STANDARD PROCEDURES INCLUDE SENDING A MEDWATCH FORM TO REPORTING FACILITIES FOR COMPLETION AND RETURN. SINCE THIS RPTR WAS A CONSUMER, NO MEDWATCH WAS SENT, AND NO INFO IS AVAILABLE FOR SECTION F1-F14. THE PT'S WEIGHT (A4) WAS NOT REPORTED.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. EVALUATION: A WHITE DATASCOPE 10 FRENCH, 6 INCH SHEATH/HEMOSTASIS VALVE ASSEMBLY WAS RETURNED FOR EVALUATION. THE ASSEMBLY WAS IN PLACE OVER THE CATHETER TUBING. VISUAL EXAMINATION REVEALED THE SHEATH TO BE KINKED AT THE SHEATH/SHEATH HUB JUNCTION AND AT ONE OTHER LOCATIONS. BLOOD WAS NOTED ON THE EXTERIOR OF THE SHEATH. AFTER THE ASSEMBLY REMOVED FROM THE CATHETER TUBING, THE SHEATH I.D. WAS WITHIN DATASCOPE'S MFG SPECIFICATIONS. A SHEATH/SHEATH HUB LEAK TEST WAS PERFORMED ON THE ASSEMBLY ACCORDING TO THE SHEATH/SHEATH HUB JUNCTION BUT NO LEAK WAS OBSERVED AT THE HEMOSTASIS VALVE/SHEATH HUB JUNCTION. THE LEAK RATE AT THE SHEATH/SHEATH HUB JUNCTION WAS WITHIN DATASCOPE'S MFG SPECIFICATIONS. PROBABLE CAUSE OF DIFFICULTY: LABORATORY EXAMINATION DID CONFIRM THE REPORTED LEAK AT THE SHEATH/SHEATH HUB JUNCTION. A SHEATH IS COMPRISED OF A HUB MOLDED AROUND THE END OF THE SHEATH TUBE. IN ADDITION, THE SHEATH IS MADE OF A SOFT MATERIAL SO AS NOT TO INJURY THE PATIENT'S ARTERY DURING THE INSERTION PROCEDURE. IT IS POSSIBLE THAT THE SHEATH WAS SUBJECTED TO TORQUE AND/OR TENSION AT THE SHEATH/SHEATH HUB JUNCTION DURING THE INSERTION PROCEDURE CREATING A LEAK CONDITION, AS EVIDENCE BY THE KINK IN THE RETURNED ITEM AT THIS LOCATION. FINALLY, IT IS WORTH NOTING THE LEAK AT THE SHEATH/SHEATH HUB JUNCTION DID NOT JEOPARDIZE BALLOON FUNCTION.
(CC# 96-00192) THE IAB LEAKED AROUND THE SHEATH. ON 10/31/96, THE FOLLOWING WAS REPORTED TO DATASCOPE: BLOOD LEAKED FROM THE SHEATH NEAR THE YELLOW HUB. THE BALLOON WAS IN PLACE FOR AT LEAST 8-16 HOURS. EVENT COMPLICATIONS: UNK - REPORTED 10/2/96 AND 10/31/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 10/3, 10/31/96.
DURING AN UNSPECIFIED PROCEDURE, THE INSTUMENT EJECTED CLIPS PREMATURELY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS NOT SENSING. THERE WAS NO PT INVOLVEMENT RELATED TO THIS EVENT.
THE "NOT SENSING" CONDITION COULD NOT BE DUPLICATED. THE PT CABLE COULD NOT BE INSERTED DUE TO A MISALIGNED PT CABLE CONNECTOR. THE SCREWS THAT KEEP THE CONNECTOR IN PROPER ALIGNMENT HAD BECOME LOOSE AFTER REPEATED INSERTIONS/REMOVAL.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE INSTRUMENT EJECTED UNFORMED CLIPS INTO THE PT'S CAVITY. THE SURGEON RETRIEVED THE CLIPS WITHOUT INCIDENT AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
DURING AN ELECTROPHYSIOLOGY PROCEDURE THIS DEVICE EXPERIENCED INTERMITTENT CONTINUITY. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE. THE DEVICE IS NOT BEING RETURNED FOR ANALYSIS.
WHILE PULLING THE NEEDLE BACK OVER THE GUIDEWIRE, THE TIP OF THE GUIDEWIRE BROKE OFF. THE PHYSICIAN USED THREE DIFFERENT SNARES TO RETRIEVE THE TIP. THE TIP OF THE GUIDEWIRE WAS RETRIEVED IN THE RIGHT VENTRICLE. PT IS FINE.
THE FREQUENCY AND SEVERITY OF OCCURRENCE ARE NOT GREATER THAN EXPECTED. SUBMISSION OR PUBLIC RELEASE OF INFO BY CO UNDER THE MDR REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THE MFR, USER FACILITY, MEDICAL PERSONNEL, DISTRIBUTOR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. GUIDEWIRE, CATALOG NUMBER US 1806, LOT NUMBER 1483503793, WAS RECEIVED IN QC FOR ANALYSIS. THE SALES REP HAD STATED THAT WHILE THE PHYSICIAN WAS PULLING THE NEEDLE BACK OVER THE GUIDEWIRE, THE TIP OF THE GUIDEWIRE BROKE OFF. THREE SNARES WERE USED TO RETRIEVE THE TIP, WHICH WAS IN RIGHT VENTRICLE. THE PT IS DOING FINE. THE SNARES WERE NOT RETURNED, ONLY TWO OF THE LABELS. THE LABELS WERE GN500, LOT NUMBER 1034, STERILIZATION DATE SEPTEMBER 1993 AND GN1000, LOT NUMBER 1363502854, STERILIZATION DATE OCTOBER 1995. VISUAL EXAM REVEALED THAT THE DISTAL BALL WELD, OR TIP OF THE GUIDEWIRE, IS STILL ATTACHED TO THE CORE WIRE. THE COIL WAS DETACHED FROM THE GUIDEWIRE AND IS INCLUDED WITH THE RETURNED PRODUCT. THE COIL IS STRETCHED AND PULLED OUT OF SHAPE. A LOT TRACE AND REVIEW OF THE DHR REVEALED NO PROBLEMS OF THIS TYPE. A PRECAUTION IN THE INSTRUCTIONS USES STATES: "GUIDEWIRES ARE DELICATE PRODUCTS. HANDLE WIRE CARE TO PREVENT THE POSSIBILITY OF COIL SEPARATION, UNCOILING AND BREAKAGE."
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. THE SURGEON INSERTED A NEW DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A LAPAROSCOPIC CHOLECYSTECTOM PROCEDURE. THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THERE WAS GAS LEAKAGE BECAUSE OF DROPPING SILICON RING OF FLAPPER BULB. THE RING WAS RETRIEVED FROM THE ABDOMEN AND A NEW TROCAR WAS USED WITHOUT DIFFICULITY.
BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT'S INNER GASKET HAD BECOME DETACHED DURING SURGERY. THE INNER GASKET WAS DETACHED AND RECEIVED IN A SEPARATE BAG. A SMALL PIECE OF THE OUTER GASKET IS TORN (2%) AND WAS NOT REC'D WITH THE INSTRUMENT. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS. APPROPRIATE ENGINEERING AND MFG PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.
THE RPTR INDICATED A SUSPECTED MALFUNCTION. THERE WAS NOT A PT INVOLVED IN THIS EVENT.
THE INABILITY OF THE PT CABLE TO BE INSERTED WAS THE RESULT OF A MISALIGNED PT CABLE CONNECTOR. THE SCREWS THAT KEEP THE CONNECTOR IN PROPER ALIGNMENT HAD BECOME LOOSE AFTER REPEATED INSERTIONS/REMOVALS.
THE INSTRUMENT WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THE CLIP APPLIER WOULD NOT FORM CLIPS CORRECTLY. ANOTHER APPLIER WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE RPT'D INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON RPT'D COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
DEVICE LABEL CODE FOR F10. POSITION 1 & 2: 1738.
WHEN THE DR. INSERTED THE IAB INTO THE PATIENT, THE IAB DID NOT INFLATE. "CHECK BALLOON" ALARM SOUNDED FROM THE SYSTEM 97 PUMP. AFTER THE IAB WAS REMOVED, THE DR. NOTICED THAT THE IAB HAD A LEAK. THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVALUATION. EVENT COMPLICATIONS: UNK - REPORTED 10/4/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 10/4/96.
THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING AND BATTERY DISCHARGE ANALYSIS. THE BATTERY IS EXPIRED - NORMAL. THE OBSERVED LOSS OF CAN ISOLATION WAS DUE TO A SHORTED CAPACITOR, C-18 IN THE OUTPUT CIRCUIT.
DURING A CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT CLOSE PROPERLY. THE SURGEON APPPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED APPROX. 73MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX. 14MM AND HAS MIGRATED DOWN LEAD BODY APPROX. 78MM PROXIMAL OF WELD SITE. IT APPEARS THAT ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO APPROX. 87MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURE.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. FAILURE ANALYSIS IS PROVIDED.
THE ELECTIVE REPLACEMENT INDICATOR AND THE INTENSIFIED FOLLOW-UP INDICATED ARE ACTIVE. A CURRENT MEASUREMENT DEFECT WAS OBSERVED.
THE OBSERVED HIGH CURRENT/ERI WAS THE RESULT OF A MALFUNCTION IN THE ANALOG TO DIGITAL SECTION OF THE ACCELEROMETER CIRCUIT ON THE "COMPANION" IC.
VACUUM PUMP PRESSURE RELIEF BOX WAS RATTLING. WHEN TOUCH BY AN OPERATOR, A SPARK WAS EMITTED AND THE CIRCUIT BREAKER TRIPPED. THERE WERE NO INJURIES AND NO PTS WERE REPORTED TO BE INVOLVED.
DEVICE 510K OR PMA# K923988. FREQUENCY ADDRESSED IN LABELING? NO. NO - FREQUENCY GREATER THAN USUAL? YES. SEVERITY ADDRESSED IN LABELING? NO. NO - SEVERITY GREATER THAN USUAL? YES. BIOMEDICAL PERSONNEL AT THE UF FOUND A LOOSENED NUT WHICH HAD SHORTED TO THE 115 VAC LINE. THE NUT WAS REATTACHED TO THE CLIP IT SUPPORTED, BOTH FUSES IN THE RELIEF BOX WERE REPLACED, AND THE PROBLEM WAS CORRECTED. THE RATTLING REFERRED IN PART B5 WAS DUE TO THE RELIEF BOX BEING MOUNTED ON TOP OF THE VACUUM PUMP AND RECEIVING VIBRATION FROM TEH RUNNING PUMP. VIBRATION IS NORMAL, BUT THE LOOSE NUT CAUSED THE RATTLE.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE DEVICE WAS DROPPING CLIPS. THERE WAS NO CONSEQUENCE TO THE PT.
10/9/96 1515 CIN SPOKE TO PURCHASING WHO REFERRED TO OR. CO STATED THE INSTRUMENT WAS DROPPING CLIPS INTERMITTENTLY THROUGHOUT THE CASE. ANOTHER WAS PULLED TO COMPLETE THE CASE. THE SURGEON WAS ABLE TO RETRIEVE THE CLIPS WHICH FELL INTO THE PT. SOME CLIPS WERE LOOSE WHEN PLACED ON THE ARTERY AND ANOTHER CLIP NEEDED TO BE APPLIED TO THAT STRUCTURE. 10/10/96 1044 DR. IS OUT OF THE OFFICE FOR TWO WEEKS, TO RETURN 10/21. WILL SEND NNCL. NNCL SENT. A1,2,3,4; B3,6,7;D10: INFO UNAVAILABLE. D5,6;H4: INFO UNAVAILABLE, PRODUCT NOT RETURNED FOR EVAL. SECTION D: ALL INFO IN D1-D10 IS THE SAME FOR PRODUCT #2 AND #3. SECTION H: ALL INFO IN H1-H10 IS THE SAME FOR PRODUCT #2 AND #3. "MEDICAL DEVICE REPORTING REGULATION (21 CFR PART 803) REQUIRES THAT CERTAIN DEVICE RELATED INFO BE REPORTED TO THE FDA. THE SUBMISSION OF THIS INFO IS WITHOUT PREJUDICE AND DOES NOT CONSTITUTE AN ACKNOWLEDGMENT OR AN ADMISSION THAT THE SUBJECT PRODUCT MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEN THE PRODUCT AND THE REPORTED DEATH OR INJURY."
THE PACER HAD INTERMITTENT LOSS OF VENTRICULAR CAPTURE.
PATIENT'S CURRENT STATUS: UNK-RPT'D 10/3, 10/31/96.
THE PACER HAD INTERMITTENT ATRIAL OVERSENSING.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED AT WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX 88MM AND HAS MIGRATED DOWN LEAD BODY APPROX 10MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO APPROX 88MM.
THE PACER HAD INTERMITTENT LOSS OF VENTRICULAR SENSING.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A SMOOTH-EDGED PENETRATION WAS SEEN AT THE LEAK SITE. PROBABLE CAUSE OF DIFFICULTY: THE PHYSICAL EVIDENCE INDICATES THAT THE SOURCE OF THE REPORTED DIFFICULTY WAS A PENETRATION OF THE MEMBRANE PROBABLY CAUSED BY CONTACT WITH A SHARP EDGED OBJECT. THE MEMBRANE DAMAGE MAY HAVE OCCURRED PRIOR TO OR DURING BALLOON INSERTION. THIS TYPE OF PENETRATION CAN PREVENT THE MEMBRANE FROM INFLATING DURING THE INITATION OF IABP.
PATIENT'S CURRENT STATUS: STABLE - RPT'D 10/18/96.
NO REPORT OF MALFUNCTION, SERIOUS INJURY OR REASON FOR EXPLANT WAS PROVIDED. FAILURE ANALYSIS INDICATES THE LEAD IS FRACTURED WITHOUT PROTRUSION.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE IS FRACTURED 37MM PROXIMAL OF WELD SITE. THE PROXIMAL PORTION OF J STIFFENER WIRE MEASURES 50MM AND HAS MIGRATED DOWN LEAD BODY 55MM PROXIMAL OF WELD SITE. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE LEAD WAS SNIPPED OR CUT 31CMS PROXIMAL OF FIXATION HELIX HOUSING ELECTRODE TIP, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURES.
THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN PROCEDURE. THE JAWS SCISSORED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL LOADING AND MOVEMENT FROM PROSTHESIS AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING AN ORTHOPEDIC PROCDURE, AN UNUSUAL TISSUE REACTION OCCURRED POST-OPERATIVELY WHICH APPEARED TO BE AN INFECTION. THE SUTURE WAS REMOVED.
11/1/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DUE TO CLINICAL ERROR, THE STATUTORY REPORTING REQUIREMENT OF 30 CALENDAR DAYS WAS EXCEEDED.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP SPITTING CLIPS. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B3,6,7: INFO NOT SUPPLIED BY AFFILIATE. D5,6; H4,6: INFO ANTICIPATED, BUT UNAVAILABALE AT THIS TIME.
THE DISPOSABLE LOADING UNIT WAS USED WITH AN INSTRUMENT DURING A LOBECTOMY. STAPLES WERE NOT PRESENT AFTER THE DEVICE WAS FIRED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING AN ORTHOPEDIC PROCEDURE, AN UNUSUAL TISSUE REACION OCCURRED POST-OPERATIVELY WHICH APPEARED TO BE AN INFECTION. THE SUTURE WAS REMOVED.
10/30/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DUE TO CLINICAL ERROR, THE STATUTORY REPORTING REQUIRMENT OF 30 CALENDAR DAYS TO REPORT WAS EXCEEDED.
THIS 27 YR OLD MALE UNDERWENT ACL RECONSTRUCTION 10/1/96. THE SCREW BROKE OF WHILE INSERTING INTO ACL GRAFT. A 7MM GUIDE WAS PLACED OVER THE TOP AND A HOLE WAS MADE WHERE THE PIN GUIDE WOULD GO. THE GUIDE PIN WS PLACED NEXT: THIS WAS THEN DRILLED WITH A 10MM ENDOSCOPIC DRILL. ECCENTRIC GUIDE WAS PLACED FROM DISTAL TO PROXIMAL, AND A NOTCH WAS MADE OVER THE ANTERIOR ASPECT OF THE FEMORAL TUNNEL. TWO-PIN PASSER WAS THEN USED AND THE GRAFT WAS THEN PASSED FROM DISTAL TO PROXIMAL. A 7X2 5 MM 6 KEY SCREW WAS PLACED UP INTO THE FEMORAL TUNNEL. AFTER 10MM OF THE SCREW WAS IN AND HAD PURCHASE, THE SCREW BROKE AND COULD NOT ADVANCE AN FURTHER NOR COULD IT BE REMOVED.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP SPITTING CLIP. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6.7; D10: INFO NOT SUPPLIED BY AFFILIATE. D5,6; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
DEVICE LABEL CODES: 1701, 1738. UNDERWATER LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
EVENT COMPLICATIONS: UNK - REPORTED 10/4/96; NONE - REPORTED 11/7/96. PATIENT'S CURRENT STATUS: STABLE - RPT'D 11/7/96.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE SURGEON FIRED THE CLIPS APPLIER REPEATEDLY WITH CLIPS NOT FORMING COMPLETELY. PROCEDURE WAS COMPLETED WITH A COMPETITOR INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
THE DISPOSABLE LOADING UNIT WAS USED WITH AN INSTRUMENT DURING A LOBECTOMY. STAPLES WERE NOT PRESENT AFTER THE DEVICE WAS FIRED. THE SURGON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE PACER HAD INTERMITTENT LOSS OF ATRIAL SENSING.
DUYRING AN ELECTROPHYSIOLOGY PROCEDURE THIS DEVICE EXPERIENCED INTERMITTENT CONTINUITY. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE. THE DEVICE IS NOT BEING RETURNED FOR ANALYSIS.
DURING AN ORTHOPEDIC PROCEDURE, AN UNUSUAL TISSUE REACTION OCCURRED POST-OPERATIVELY WHICH APPEARED TO BE AN INFECTION. THE SUTURE WAS REMOVED.
11/01/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFR. DUE TO CLERICAL ERROR, THE STATUTORY REPORTING REQUIREMENT OF 30 CALENDAR DAYS TO REPORT WAS EXCEEDED.
NO REPORT OF MALFUNCTION, SERIOUS INJURY OR REASON FOR REMOVAL WAS PROVIDED. FAILURE ANALYSIS INDICATES THE LEAD IS FRACTURED WITHOUT PROTRUSION.
THIS ENTIRE REPORT COMPLETED BY MFR. X-RAY OF LEAD INDICATES THE J STIFFENER WIRE HAS FRACTURED 10MM PROXIMAL OF ELECTRODE TIP. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS.
SECTION B 5-THE DR FELT HE WOULD CAUSE MORE DAMAGE BY REMOVING THE BROKEN PIECE. HE MADE AN INCISION IN THE FEMUR AND USED A PLASTIC BUTTON TO COMPLETE THE PROCEDURE. ADD'L INFO.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE. THE CLIPS DID NOT FORM PROPERLY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE CHARGE TIME EXCEEDED 30 SECS FOR THE SECOND BATTERY. CHARGE TIME TEST FOLLOWING CAPACITOR REFORM WITH POST-CHARGE BATTERY VOLTAGE WAS 2.6V.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECSTECTOMY. THE ER320 WAS SPITTING CLIPS AND THE CLIPS WOULD NOT COMPLETELY CLOSE. INSTRUMENT WAS FROM A PROCEDURE TRAY, LOT NUMBER J43D56. THERE WAS NO CONSEQUENCE TO THE PT.
10/2/96 1610 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/3/96 NNCL SENT. A1,2,3,4; B3,6,7; D10; H4; INFO UNAVAILABLE. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGED OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE DEVICE WAS GIVEN TO THE REP AND TOLD "WOULD NOT CUT." NO OTHER INFO WAS AVAILABLE. THE CONTACT PERSON STATED IT WAS SO LONG AGO SHE COULD NOT REMEMBER. THERE WAS NO CONSEQUENCE TO THE PT.
THE RPTR INDICATED THAT AT THE PREVIOUS FOLLOW-UP ON 9/1, THE MAGNET RATE WAS 86.1 PPM. AT THE NEXT FOLLOW-UP ON 10/1, THE DEVICE HAD NO OUTPUT. THE DEVICE IS ON SAFETY ALERTY.
SUMMARY ANALYSIS: THE OBSERVED NO OUPUT WAS THE RESULT OF LOW MODULE VOLTAGE DUE TO MALFUNCTION IN THE PACER POWER SOURCE, BT 1.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
11/4/1996- SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. MEDWATCH REPORT RECEIVED BY MFG. ON 10/4/1996. ADDTIONAL PT CODES AND DEVICE CODES SUBMITTED BY THE HOSP ARE ENTERED IN F10. DEVICE EVAL NARRATIVE: THE CATHETER WAS RETURNED FOR EVAL. THE CATHETER DISPLAYED DAMAGE, CONSISTENT WITH LOCATION OF THE COMPONENT IN THE ANATOMICAL PINCH POINT BETWEEN THE CLAVILCE AND THE FIRST RIB. APPLICATION OF THE CATHETER IN THIS MANNER IS CAUTIONED AGAINST IN THE PRODUCT INFO LITERATURE WHICH ACCAMPANIES EACH DEVICE SHIPMENT.
THE CATHETER WAS REMOVED BY THE RADIOLOGIST THROUGH THE FEMORAL ARTERY. TWO DAYS LATER, THE PORT WAS SURGICALLY EXPLANTED.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATTCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULT: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
ON 10/18/96, DATASCOPE WAS NOTIFIED THAT THERE WERE NO FURTHER COMPLICATIONS FROM THE EVENT AND THE PATIENT'S CURRENT STATUS IS STABLE. EVENT COMPLICATIONS: LOST PULSES/FEM-FEM CROSSOVER-RPT'D 10/4; NONE-RPT'D 10/18/96. PATIENT'S CURRENT STATUS: STABLE-RPT'D 10/18/96.
THE RPTR INDICATED THAT THE PT WAS UNDERGOING REPLACEMENT OF A 284-02V. BOTH LEADS VS1, FIT IN THE HEADER OF THE NEW 284-05, BUT WHEN THE SIDELOCK CONNECTOR IS PUSHED IN, IT POPS OUT. THE SIDELOCK WILL NOT STAY CLOSED. ANOTHER 284-05 WAS TRIED AND THE OUTCOME WAS SUCCESSFUL.
THE REPORTED "SIDELOCK WONT' CLOSE" WAS VERIFIED DURING BENCH TESTING. THE ANALYSIS REVEALED INSUFFICIENT FRICTION EXISTS IN THE SIDELOCK ASSEMBLY TO ENSURE THAT THE SIDELOCK WILL REMAIN CLOSED ON A CHRONIC LEAD.
DURING AN ELECTROPHYSIOLOGY PROCEDURE, THIS DEVICE EXPERIENCED INTERMITTENT CONTINUITY. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR ANALYSIS.
INVESTIGATION CONDUCTED. DR CITES EPITHELIZATION OF THE POT EXTRACTION SITE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THERE WAS AN OPENING BETWEN CLIPS AND JAW, CLIPS WERE DROPPED FROM JAW TWICE. IT ALSO CAUSED SCISSORING. THE SURGEON USED  NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D10: INFO NOT SUPPLIED BY AFFILATE. D5,6;H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHLOLECSTECTOMY. THE ER320 CLIP WOULD NOT FORM AND FEED PROPERLY. TWO CLIPS WOULD SPIT OUT OF THE DEVICE WHEN THE TRIGGER WAS INITIALLY SQUEEZED. OF THE TWO, ONE CLIP WOULD BE PARTIALLY FORMED, THE SECOND CLIP WOULD BE UNFORMED. THERE WAS NO PT CONSEQUENCE. 10/2/96 REP REPORTS THE PROCEDURE WAS COMPLETED WITH ANOTHER CO'S CLIP APPLIER.
10/03/96 1510 LEFT MESSAGE AND 800# FOR THE M.D. TO CALL BACK. 10/04/96 NNCL SENT. A1,2,3,4; B6,7; D5,6; 10; H4; INFO UNAVAILABLE.
DURING AN UNSPECIFIED PROCEDURE, REPORTEDLY, THE VISBILITY THROUGH THE SCOPE WAS NOT CLEAR. NO PT INJURY.
10/30/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DUE TO A CLERICAL ERROR, THE STATUTORY REPORTING REQUIRMENT OF 30 CALENDAR DAYS TO REPORT WAS EXCEEDED.
THE RPTR INDICATED THAT THE PT CAME IN FOR FOLLOW-UP. DURING INQUIRY, THE SERIAL NUMBER SCREEN WAS LOST. NO KNOWN EXPOSURE TO CAUTERY, DEFIBRILLATION, ETC. DEVICE PACING AND CAPTURING (RATES UNKNOWN). DEVICE HAS BEEN IN IFI (INTENSIFIED FOLLOW-UP INDICATOR) SINCE JUNE. THE CODE WAS GIVEN TO RESTORE THE SERIAL NUMBER, NOT UNSURE AS TO RATE OF SUCCESS. THE PT WAS TOTALLY PACER DEPENDENT AND THE DR POSSIBLY DID NOT WANT TO RESTORE DUE TO THE POSSIBILITY OF PAUSES DURING THE PROCESS.
REF F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECSTECTOMY. THE CLIP MALFORMED FROM THE SECOND FIRING. AFTER THAT CLIP JAMMED THE SURGEON USED NEW CLIP APPLIER TO FINISH THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
EVALUATION SUMMARY INADVERTENTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED WITH THE CLIP JAMMED UNDER THE FLOOR. NO CONCLUSION COULD BE REACHED AS TO HOW THE CLIP HAD BECOME JAMMED. THE JAMMED CLIP WAS REMOVED AND THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION. IF THERE IS TOO MUCH TISSUE INTO THE JAWS, THE CLIP MAY BECOME JAMMED UNDER THE FLOOR. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
H6: METHOD CODE 00: CO TESTED FRESH SETS OF PADS THAT WE BELIEVE CAME FROM THE SAME OR A VERY SIMILAR LOT AS THE PADS USED DURING THE EVENT. H6: CONCLUSION CODE 00: CO'S INVESTIGATION INDICATES THAT ANOTHER CO'S PACING/DEFIBRILLATING/MONITORING ELECTRODES ARE NOT COMPATIBLE WITH CO'S DEFIBRILLATORS, ESPECIALLY IN EXTERNAL PACING APPLICATIONS. H7: OTHER: CO HAS CONTACTED OTHER CO REGARDING THIS MATTER WITH THE INTENT TO WORK COOPERATIVELY TO INFORM CUSTOMERS WHO ARE USING THESE OTHER CO'S PADS WITH CO DEFIBRILLATORS OF THIS INCOMPATIBILITY. INVESTIGATION RESULTS: CO'S INVESTIGATION OF THE PADS SUPPLIED BY THE HOSP REVEALED THAT THEY QUICKLY DEVELOP HIGH DC OFFSET VOLTAGES WHEN USED TO DELIVER SHOCKS OR WHEN USED TO PACE. DEFIBRILLATORS ARE DESIGNED TO TOLERATE MORE THAN TWICE THE DC OFFSET SPECIFIED BY AAMI. THE OFFSET VOLTAGES WHICH ARE DEVELOPED IN THE PADS EXCEED THE DC OFFSET TOLERANCE, WHICH CAUSED THE DEFIB TO CONCLUDE THAT THE PADS WERE "OFF" FOR SAFETY REASONS, WHEN THE DEFIB DETERMINES THAT THE PADS ARE "OFF", IT INHIBITS THE DELIEVRY OF ENERGY THROUGH TO THE PADS. IN THIS INCIDENT THE LARGE DC OFFSET DEVELOPED ACROSS THE PADS BY THE SERIES OF DEFIB SHOCKS AND THE SEVERAL MINUTES OF PACING CAUSED THE DEFIB TO DETERMINE THAT THE PADS WERE OFF, THUS INHIBITING THE DELIVERY OF ENERGY TO THE PADS.
AFTER 18 HOURS OF USE BLOOD WAS NOTED THE IAB WAS REMOVED AND NOT REPLACED. PT REPORTED AS DOING FINE.
H-11 -ALL UNK INFO REQUESTE BUT NOT RECEIVED. H-11 SECTION F PROVIDED BY MFR.
INVESTIGATION CONDUCTED. DR DOES NOT CITE ANY CAUSE FOR FAILURE, THEREFORE, IT'S UNKNOWN. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A  FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
THE DEVICE WAS USED DURING A LOBECTOMY. THE SURGEON STATED THE DEVICE "IS DEFECTIVE-IMPROPER FORMING OF STAPLE." THE SURGEON HAD TO OVERSEW THE STAPLE LINE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THE REP HAS BEEN UNSUCCESSFUL AT OBTAINING ANY OTHER INFO. THERE WAS NO CONSEQUENCE TO THE PT. 10/7/96 NO BUTTRESSING MATERIAL WAS USED.
A1,2,3,4:B6,7;D10: INFO NOT PROVIDED. 10/7/96 1210 MESSAGE AND 800# LEDT FOR MD CALL BACK. 10/8/96 NNCL SENT. 10/8/96 1550 DR CALLED BACK (NNCL REMOVED FROM MAIL PILE.) DR STATED ON THE FIRST FIRING OF THE INSTRUMENT ON THE PULMONARY VEIN THE INSTRUMENT FIRED WITHOUT DIFFICULTY. UPON REMOVAL OF THE INSTRUMENT, BLOOD FILLED THE PT'S THORACIC CAVITY AND THERE WERE NO STAPLES VISIBLE IN THE TISSUE OR IN THE CARTRIDGE. ANOTHER INTRUMENT WAS USED TO COMPLETE THE CASE. NO BUTTRESSING MATERIAL WAS USED. D5;H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SAFETY SHIELD WOULD NOT RETRACT WHEN APPLIED TO TISSUE. THE SURGEON USED A NEW INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A GALL BLADDER PROCEDURE. THE CLIP AS DELIVERED ACROSS THE TRACK. IT DOESN'T HOLD IN THE JAW AND FELL. IT HAS BEEN REMOVED. THERE WAS NO CONSEQUENCE TO THE PT.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT OF THE IMPLANT, INFECTION & SURGICAL TRAUMA AS CAUSES FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
WHILE A PT WAS BREATHING ON THE DEVICE, SOME SMALL, RUBBER PIECES OF MATERIAL ENDED UP IN THE PT'S MOUTH. NO HARM OCCURRED TO THE PT AS SHE SIMPLY SPIT OUT ALL OF THE RUBBER PIECES. NO MEDICAL INTERVENTION WAS REQUIRED.
FREQUENCY ADDRESSED IN LABELING? NO. FREQUENCY GREATER THAN USUAL? UNK. SEVERITY ADDRESSED IN LABELING? NO. (NO)-SEVERITY GREATER THAN USUAL? UNK. USER PERSONNEL REMOVED, INSPECTED AND CLEANED THE BREATHING VALVE ASSEMBLY BUT DID NOT FIND ANY SOURCE  OF EITHER RUBBER OR PLASTIC PIECES OF MATERIAL. PRODUCTION OF THE DEVICE WAS DISCONTINUED IN 1990.
THE DEVICE WAS USED DURING OPEN HEART SURGERY. THE CLIPS DID NOT FIRE OR FORM PROPERLY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE SAFETY SHIELD DID NOT RETRACT TO FACILITATE PENETRATION. THE SURGEON USED ANOTHER DEVICE. NO PT INJURY REPORTED.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. THE INSTRUMENT DID NOT CUT THE TISSUE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/30/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. STAPLES APPEAR TO HAVE PREFIRED WHILE IN TRANSIT. NOTICED BY SCRUB PERSON ON REMOVAL FROM PACK INSTRUMENT WAS NOT USED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFO NOT SUPPLIED BY AFFILATE. D5,6;H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
BLOOD LEAK FROM THE OXYGENATOR. THE MEMBRANE WAS CHANGED OUT WITH NO COMPLICATION TO THE PT.
H-11-ALL UNK INFO REQUESTED BUT NOT REC'D.
INVEWTIGATION CONDUCTED. DR. DOES NOT CITES ANY CAUSE FOR FAILURE, THEREFORE, IT'S UNK. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCURRING AT A FREQUENCY AND SEVIERTY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DVICE.
PT WENT INTO EMD. WHEN HE BEGAN TO SHOW PATTERN OF FIBRILLATION, 2 SUCCESSFUL COUNTERSHOCKS WERE DELIVERED THEN. DEFIBRILLATOR FAILED TO FIRE THREE ATTEMPTS, THEN STAFF GOT ANOTHER UNIT. ON LAST ATTEMPT, UNIT FIRED, BUT STAFF SAW SMOKE AND SPARKS. DO NOT KNOW IF DEFIBRILLATOR WAS PLUGGED INTO WALL SOCKET. UNABLE TO FIND CAUSE OF PROBLEM.
DURING A DIAGNOSTIC LAPAROSCOPY PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT DURING PENETRATION. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A RIGHT HEMICOLECTOMY. SURGEON REPORTS THAT HE FIRED THE TLC75 THEN INSTRUMENT WAS RELOADED. ON THIS SECOND FIRING THERE WERE STAPLES MISSING FROM THE PROXIMAL END OF THE ANASTOMOSIS. THERE WERE STAPLES AT THE DISTAL END. SURGEON NOTICED DEFECT AND CORRECTED WITH SUTURES. SURGEON CONCERNED THAT IF HE DIDN'T NOTICE, ANASTOMOSIS WOULD HAVE FAILED. THERE WAS NO CONSEQUENCE TO THE PT.
CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS FIRED WITH A RELOAD CARTRIDGE AND FIRED AND FORMED STAPLES AS DESIGNED ACROSS THE ENTIRE STAPLE LINE. IT SHOULD BE NOTED THAT DURING MFG, ALL THE CARTRIDGES ARE 100% INSPECTED TO ENSURE THAT ALL STAPLES ARE PRESENT PRIOR TO SHIPMENT. THE BATCH HISTORY RECORDS WERE REVIEWED FOR THIS BATCH AND THE WERE NO ANOMOLIES NOTED FOR MISSING STAPLES. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
THROMBUS FORMATION WAS NOTED ON THE RESERVOIR WALL AFTER AN UNDETERMINED AMOUNT OF TIME. THE OXYGENATOR WAS CHANGED OUT, THE PT IS REPORTED AS DOING FINE.
H-10 NO DIRECT CODE FOR THROMBOSIS FORMATION. H-11 ALL UNK INFO REQUESTED BUT NOT RECEIVED. H-11 SECTION F PROVIDED BY MFR.
IT WAS NOT POSSIBLE TO ADVANCE THE CATHETER ANY FURTHER INTO THE PT BECAUSE THERE WAS NO MORE USABLE LENGTH. THERE WAS NO PT INJURY OR COMPLICATIONS AS A RESULT OF THE EVENT. EVENT COMPLICATIONS: UNKNOWN - REPORTED 10/2/96. PT'S CURRENT STATUS: UNK - RPT'D 10/2/96.)
HIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVAL. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. ANY ADD'L INFO RECEIVED BY CO WILL BE REPORTED.
THE DEVICE WAS APPLIED DURING AN AORTIC CLOSURE. THE INSTRUMENT WAS DIFFICULT TO REMOVE FROM THE APPLICATION SITE. THE SURGEON MANUALLY MANIPULATED THE DEVICE FREE FROM TISSUE AND OBSERVED UNFORMED STAPLES. ANOTHER DEVICE WAS APPLIED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE. THE SUTURE BROKE AS KNOTS WERE BEING TIED. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/17/1996-SUPPLEMENT REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. RETURNED FOR EVAL WERE CLINICAL STRANDS OF SUTURE AND UNUSED REP SAMPLES OF SUTURE. BROKEN FOR EVAL WERE OBSERVED AS REPORTED. OUR EVAL DETERMINED THAT THIS TYPE OF BREAK OBSERVED COULD HAVE BEEN THE RESULT OF HANDLING TECHNIQUE BUT OUR OBSERVATIONS ARE NOT CONCLUSIVE AS TO CAUSE. THE SEALED UNITS WERE TESTED FOR TENSILE STRENGTH AND MET BOTH INTERNAL AND USP SPECIFICATIONS FOR THESE VALUES.
DURING A PROCEDURE THE VALVE LEAKED LOOSING 10CC OF BLOOD. THE VALVE WAS CHANGED OUT WITH NO COMPLICATIONS TO THE PT.
ALL UNKINFO REQUESTED BUT NOT REC. SECTION F PROVIDED BY MANUFACT.
DURING A DIAGNOSTIC LAPAROSCOPY PROCEDURE, THE SAFETY SHIELD WOULD NOT RETRACT DURING PENETRATION. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/7/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
SUMMARY OF EVAL: THE COMPLAINT WAS NOT VERIFIED. EVAL RESULTS INDICATE THE DEVICE FUNCTIONED AS INTENDED. THE NOZZLE FRACTURED WELL AFTER THE CEMENT WAS INJECTED INTO THE CANAL AFTER HARDENING WITH CEMENT.
PT WENT INTO EMD. WHEN HE BEGAN TO SHOW PATTERN OF FIBRILLATION, 2 SUCCESSFUL COUNTERSHOCKS WERE DELIVERED, THEN: DEFIBRILLATOR FAILED TO FIRE (THREE ATTEMPTS), THEN STAFF GOT ANOTHER UNIT. ON LAST ATTEMPT, UNIT FIRED, BUT STAFF SAW SMOKE AND SPARKS. DO NOT KNOW IF DEFIBRILLATOR WAS PLUGGED INTO WALL SOCKET. UNABLE TO FIND CAUSE OF PROBLEM.
HOSP BIO-MED REPORTS THAT NO STRIPS ARE AVAILABLE FROM THE EVENT; THE RECORDER HAD BEEN TURNED OFF INADVERTENTLY BY THE NURSES. THE DEFIB WAS TESTED FOR FOUR DAYS BY THE HOSP BIO-MED WITH NO FAILURES NOTED. THE UNIT HAS BEEN RETURNED TO SERVICE WITH NO SUBSEQUENT PROBLEMS.
DR EXPERIENCED OOZING OF GRAFT DURING THE PROCEDURE. THIS OCCURRED AT CERTAIN AREAS ESPECIALLY AT THE TIP END OF THE ANASTOMOSIS. SURGICAL GEL WAS USED TO STOP THE BLEEDING. NO INTERVENTION TO THE PT WAS NEEDED. PT IS FINE.
H-11 ALL UNK INFO REQUESTED BUT NOT RECEIVED. H-11 SECTION PROVIDED BY MFR. H-10 SECTION D8 GRAFT STIL IN PT. SECTION H6 CODE 44 REFERES TO THE DEVICE WAS RETURNED AS A BIOHAZARD. IT WAS VISUALLY EXAMINED.
THE DEVICE WAS USED DURING A ROUTINE PROCEDURE. REPORTEDLY, THE SURGEON STATED THE STAPLE LINE LEAKED SO HE MANUALLY OVERSEWED. NO PT INJURY REPORTED. THE CLINCALLY APPLIED DEVICE WAS DISCARDED.
11/1/96 - SUBMISSION OF INITIAL REPORT TO FDA. MEDWATCH REPORT NOT RECEIVED BY MFR.
THE DEVICE WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. THE INSTRUMENT WAS INSERTED INTO THE CAVITY AND WOULD NOT OPEN. AFTER MANIPULATION THE DEVICE FIRED AND OPENED WITHOUT INCIDENT.
THE DEVICE WAS USED DURING A THORACOSCOPIC VOLUME REDUCTION PROCEDURE. THE ANVIL DISENGAGED AS THE SURGEON WIPED THE SURFACE CLEAN. NO PT INJURY REPORTED. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.
EVAL OF THE DEVICE FOUND THE ENGAGEMENT ANGLE OF THE ANVIL COMPONENT WAS INACCURATE.
RESULTS OF EVAL: CONCLUSION-BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTING, NO CONLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE CLIPS WITHIN DESIGN SPEC WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS-EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
DURING A LAPAROSCOPIC SALPINGECTOMY PROCEDURE, REPORTEDLY, THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE TISSUE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING AN UNSPECIFIED VASCULAR PROCEDURE, THE SUTURE BROKE AS THE KNOT WAS BEING TIED. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. THE INSTRUMENT DID NOT FIRE PROPERLY AND THE CARTRIDGE DISENGAGED INTO THE PT'S CAVITY. THE SURGEON RETRIEVED THE CARTRIDGE AND COMPLETED THE PROCEDURE WITHOUT INCIDENT.
11/22/96- SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADD'L DATA ENTERED IN D9. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN F9.
THE DEVICE WAS USED DURING A ROUX EN Y PROCEDURE. REPORTEDLY, THE SURGEON STATED THE STAPLE LINE LEAKED SO HE MANUALLY OVERSEWED. NO PT INJURY REPORTED. THE CLINCALLY APPLIED DEVICE WAS DISCARDED.
AFTER 48 HOURS OF USE THE IABP ALARMED AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED AND NOT REPLACED. PT STATUS WAS REPORTED AS STABLE.
H-11 ALL UNK INFO REQUESTED BUT NOT RECEIVED. H-11 SECTION F PROVIDED BY MFR.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING AN OOPHERECTOMY PROCEDURE. REPORTEDLY, THE CARTRIDGE DISENGAGED INTO THE PT'S CAVITY. THE COMPONENT WAS RETRIEVED LAPAROSCOPICALLY WITHOUT INCIDENT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.
5/8/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL RESULTS CODE ENTERED IN H6(200). THE DISPOSABLE LOADING UNIT (CARTRIDGE) LOADED AND REMAINED SECURE BUT THE APPROXIMATING LEVER BROKE DUE TO USER MISHANDLING.
THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE. THE INSTRUMENT WOULD NOT CLOSE OR FIRE PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/1/96-MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE SAFETY SHIELD DID NOT RETRACT DURING PENETRATION. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC SPLENECTOMY PROCEDURE. REPORTEDLY, THE PNEUMOPERITONEUM LEAKED FROM THE PORT. NO PT INJURY REPORTED.
THE DEVICE WAS USED DURING A TOTAL HYSTERECTOMY PROCEDURE. THE ISNTRUMENT WAS DIFFICULT TO REMOVE FROM THE APPLICATION SITE. THE SURGEON REMOVED THE DEVICE. NO PT INJURY REPORTED.
11/1/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE ER230 FIRED 3 TIMES SUCCESSFULLY. THE NEXT 2 CLIPS FIRED BUT DID NOT CLOSE COMPLETELY. THE INSTRUMENT WAS HANDED OFF AND FIRED AT THE BACK TABLE SEVERAL TIMES AND APPEARED TO THEN FIRE APPROPRIATELY. THE INSTRUMENT WAS UASED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. INSTRUMENT WAS FROM AN FTR72 KIT, LOT NUMBER J4415N.
10/2/96 1615 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/3/96 NNCL SENT. A1,2,3,4; B6,7; D10: INFO UNAVAILABLE. D5; H4,6; INFO UNAVAILABLE AT THIS TIME. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAM, AND THE FUNCTIONAL TESTING, NO CONLCUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICIAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPEC WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.
THE SUTURE WAS USED FOR FASIA CLOSURE. THE SUTURE BROKE WHEN PARTIALLY ABSORBED. NO PT INJURY REPORTED.
11/01/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
DURING AN UNSPECIFIED PROCEDURE, THE SUTURE DISENGAGED FORM THE JAWS. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
HEALTHCARE PROFESSIONAL STATED THE PT IS EXPERIENCING CHF. THE CARDIOLOGIST INTERPRETED AN X-RAY OF THE RING AS THE RING LOSING SHAPE AND APPEARANCE TO BE SEPARATED. THE SURGEON DOES NOT FEEL THAT THE PT'S CONDITION IS RELATED TO THE RING, NOR THAT THE RING IS MALFUNCTIONING. THE SURGEON DOES NOT WANT TO REOPERATE DUE TO THE PT'S AGE.
H10. "SUBMISSION OF INFO BY CO UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." EVAL METHOD CODE #86 OTHER=DEVICE HISTORY REVIEWED. RESULTS CODE# 100 OTHER=DEVICE HISTORY REVIEW FOUND THAT THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR CLINICAL USE. H1 OTHER: THE SURGEON INDICATES THAT THERE IS NOT A PROBLEM WITH THE RING AND THAT THE PT'S CONDITION IS NOT RELATED TO THE PRODUCT. HOWEVER, IN A REPORT TO PT'S FAMILY, CARDIOLOGIST REFERS TO A SEPARATION OF THE RING. BECAUSE THE INVESTIGATION HAS NOT BEEN ABLE TO DETERMINE WHAT HE IS REFERING TO, THIS REPORT WILL BE FILED AS A PRODUCT RELATED EVENT-CLASSIFICATION=OTHER. NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY THEREFORE, INFO ON THIS MEDWATCH FORM 3500A WAS COMPLETED BY CO WITH INFO RECEIVED FROM THE HEALTHCARE PROFESSIONAL. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A." H3 ANALYSIS: THE PRODUCT REMAINS IMPLANTED AND THEREFORE COULD NOT BE EVALUATED. HOWEVER, THE DEVICE HISTORY INDICATED THAT THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR CLINICAL USE. IN ADDITION, DR, THE SURGEON, INDICATED THAT THE PT'S CONDITION WAS NOT A RESULT OF A DEFECTIVE RING. A REQUEST WAS MADE TO OBTAIN PERMISSION FOR CO TO REVIEW THE CINE. NO RESPONSE HAS BEEN RECEIVED. INVESTIGATION CONTINUES TO TRY TO CLARIFY WHAT THE CARDIOLOGIST SEES ON THE CINE AS THE RING DOES HAVE A RADIOPAQUE RING THAT IS SEPARATED AND IS FLEXIBLE; THEREFORE ON CINE DURING SYSTOLE WILL APPEAR DISTORTED COMPARED TO A SOLID RING. ANY ADD'L INFO WILL BE FORWARDED IN A FOLLOW-UP REPORT WHEN RECEIVED.
THE PRODUCT WAS USED DURING A WEDGE RESECTION PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO REMOVE FROM THE APPLICATION SITE. THE SURGEON MANUALLY MANIPULATED THE DEVICE OFF THE TISSUE WITHOUT INJURY TO THE PT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC SALPINGECTOMY PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE TISSUE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
11/1/96 - SUBMISSION OF INITIAL REPORT TO FDA. MEDWATCH NOT RECEIVED BY MFR.
THE DEVICE WAS USED DURING A GASTRO-PLASTIC SURGERY. REPORTEDLY, THE INSTRUMENT DID NOT CUT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED. EXPIRATION DATE 5/31/01.
11/1/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
11/1/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSIN OF INITIAL REPORT TO FDA BY MFG.
DURING A COLECTOMY PROCEDURE, THE SUTURE BROKE WHEN TYING A KNOT. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A ROUTINE PROCEDURE. REPORTEDLY, THE SURGEON STATED THE STAPLE LINE LEAKED SO HE MANUALLY OVERSEWED. NO PT INJURY REPORTED. THE CLINICALLY APPLIED DEVICE WAS DISCARDED.
DEVICE WAS REMOVED FROM THE PT AND A DEVICE WAS IMPLANTED DUE TO A LEAK BETWEEN CONNECTOR (PUMP TO CYLINDER).
THE DEVICE WAS USED DURING A LAPAROSCOPIC SPLENECTOMY PROCEDURE. THE PNEUMOPERITONEUM LEAKED FROM THE PORT. NO PT INJURY REPORTED.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO SST DEFORMITY.
CYLINDER HAD OR DAMAGE. CYLINDER HAD OR DAMAGE.
DURING A MASTECTOMY PROCEDURE, THE SUTURE BROKE WHEN TYING A KNOT. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURED.
DURING A ROUTINE PROCEDURE, THE SURGEON STATED THE STAPLE LINE LEAKED SO HE MANUALLY  OVERSEWED. NO PT INJURY REPORTED. THE CLINCALLY APPLIED DEVICE WAS DISCARDED.
THE DEVICE WAS APPLIED DURING A RIGHT HEMI-COLECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
11/5/96. ADDITIONAL INFORMATION ENTERED IN D9, E1 ADDRESS & PHONE #), F5. CORRECTED DATA IN E1 (INITIAL REPORTER NAME). DEVICE EVALUATION INDICATED AND CODES ENTRED IN D3 & D6.
AN OPHTHALMOLOGIST REPORTED THAT A FEMALE PT, WHO WAS REFERRED TO HIM BY AN OPTOMETRIST, EXPERIENCED A CHEMICAL BURN TO THE CORNEA AFTER USING DISINFECTING SOLUTION AND NEUTRALIZING TABLETS WITH B12. THE DR. NOTED THAT THE SOLUTION IN THE CUP HAD AN "ACETONE-LIKE SMELL." HE ALSO NOTED THAT THE CUP HAD TURNED WHITE AND LOOKED "ETCHED", RATHER THAN CLEAR. OCUFLOX AND VOLTAREN WERE PRESCRIBED AS TREATMENT TO PRECLUDE A PERMANENT INJURY. THE DR. FEELS THAT THE SOLUTION MAY NOT BE DISINFECTING SOLUTION AND THAT THE PT MOST LIKELY POURED OR MIXED AN ACETONE-LIKE SUBSTANCE IN THE CUP IN ERROR. THE DR. STATED THAT HE DID NOT FEEL THAT THE SOLUTION IN THE CUP CAME OUT OF THE BOTTLE. THE DR. OBTAINED A SAMPLE FROM THE PT AND HAS  SUBMITTED IT TO CO FOR CHEMICAL AND ANALYTICAL TESTING. OCUFLOX AND VOLTAREN WERE PRESCRIBED.
LOT NUMBER AND EXPIRATION DATE ARE UNK. SAMPLE OF COMPLAINT UNIT WAS NOT IN ORIGINAL CONTAINER.
POWDER CHAMBER LID EXPLODED ON TWO SEPARATE UNITS ON SEPARATE OCCASIONS. FORTUNATELY NEITHER THE PT NOR THE HYGIENIST WERE INJURED BY THE MISSILE. REPAIRMAN CONTACTED MFR AND THE ONLY EXPLANATION GIVEN WAS FATIGUE OF THE THREADS. THE THREADS WERE TORN OFF THE CAP DURING THE INCIDENT. IT WAS RECOMMENDED THAT A NEW LID AND CHAMBER HOUSING BE USED TO SOLVE THE PROBLEM. RPTR BELIEVES THE UNIT SHOULD NOT HAVE FAILED AT SUCH AN EARLY AGE. RPTR IS CONCERNED THAT UNIT MAY DO THE SAME THING WHEN RETURNED TO SVC. ALSO WORRIED TOO THAT TWO OTHER UNITS WILL DO THE SAME THING AND THAT SOMEONE WILL BE SERIOUSLY INJURED IN THE PROCESS.
DR WAS SENT INVESTIGATION FORM. IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY CO ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH MFR'S SPECIFICATIONS. THE PERIAPICAL RADIOGRAPH DATED 10-2-96 SHOWES A 10MML 3.7MMD IMPLANT IN THE #30 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
PLAINTIFF ALLEGED THAT SHE DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS CAUSED BY EXTENDED EXPOSURE TO LATEX GLOVES MADE BY CO, AS WELL AS MANY OTHER GLOVE MFRS.
DATE SENT TO FDA> 11/7/96. B4 AND F8 DATE IS THE DATE THAT THIS INFO WAS RECEIVED BY CO. G4 DATE IS THE DATE THAT CO RECEIVED THIS INFO. H6 NA WAS USED DUE TO NO SAMPLE AND NO LOT NUMBER AVAILABLE FOR INVESTIGATION.
IN RPTR'S DENTAL OFFICE RPTR NOTICED A PECULIAR BURNING SMELL COMING FROM ONE OF THE ROOMS. SOME OF THE LATEX GLOVES WERE STUCK TOGETHER AND LOWER PART OF THE BOX HAD BURNED HOLE WHICH ALSO DAMAGED THE DRAWER. RPTR CALLED SUPPLIER TO REPORT THE EVENT. DIST WAS CONFUSED AND UNAWARE OF SUCH POSSIBILITY.
CUSTOMER REPORTED THEY FELT THE OUTPUT OF THE VAPORIZER WAS LOWER THAN EXPECTED. THERE WAS NO REPORTED PT INJURY.
THERE ARE MANY REPORTS IN THE MEDICAL LITERATURE WHICH SUGGEST THAT THE PERFORMANCE OF DIFFERENT TYPES OF HALOTHANE VAPORIZERS HAVE BEEN ADVERSELY AFFECTED BY CORROSION. THE REPORTS REFER TO A REACTION AMONG HALOTHANE, MOISTURE AND OTHER SUBSTANCES, SUCH AS CLEANING AGENTS, WHICH CONTRIBUTE TO THE DECOMPOSTION OF HALOTHANE. CO HAS RECEIVED A NUMBER OF REPORTS THAT CERTAIN CO'S VAPORIZERS FOR HALOTHANE HAVE HAD THE PERCENTAGE CONTROL DIAL STICK IN THE "OFF" POSITION OR HAVE DELIVERED CONCENTRATIONS OF ANESTHETIC AGENT DIFFERENT FROM THAT INDICATED BY THE PERCENTAGE CONTROL DIAL SETTING. NO REPORTS RECIEVED BY CO HAVE INVOLVED PT INJURY. CO HAS THOROUGHLY INVESTIGATED THESE REPORTS AND HAS FOUND THAT THE REPORTED VAPORIZER OPERATION IS CAUSED BY THE CORROSION OF THE METAL INTERNAL CONTROL VALVE. CO HAS DETERMINED THAT SUCH CORROSION RESULTS FROM THE DECOMPOSITION OF HALOTHANE. IN MOST OF THE REPORTS RECEIVED BY CO, THE CORROSION OF THE INTERNAL CONTROL VALVE CAUSED THE VAPORIZER'S PERCENTAGE CONTROL DIAL TO STICK IN THE "OFF" POSITION, RENDERING THE VAPORIZER INOPERATIVE. HOWEVER,IN A NUMBER OF THE REPORTS WHERE THE VAPORIZER COULD BE OPERATED, THE DELIVERED CONCENTRATION OF ANESTHETIC AGENT WAS DIFFERENT THAN THE CONCENTRATION INDICATED ON THE VAPORIZER PERCENTAGE CONTROL DIAL. AS A RESULT OF THE INVESTIGATION, CO HAS DETERMINED THAT THE DECOMPOSITION OF HALOTHANE CAUSES THE RELEASE OF HALIDES WHICH MAY CORRODE METAL COMPONENTS, SUCH AS THE INTERNAL CONTROL VALVE, PARTICULARLY IN THE PRESENCE OF MOISTURE. CO FURTHER BELIEVES THAT A PRSERVATIVE ADDED TO THE HALOTHANE BY ITS MANUFACTURERS TO IMPEDE DECOMPOSITION CAN LEAVE A RESIDUE WHICH MAY CAUSE VAPORIZER COMPONENTS, SUCH AS THE PERCENTAGE CONTROL DIAL, TO STICK. CO'S INVESTIGATION ALSO REVEALED THAT HALOTHANE IS USED INFREQUENTLY IN MANY HOSPITALS. AS A RESULT, VAPORIZERS FILLED WITH HALOTHANE MAY BE INACTIVE FOR LONG PERIODS OF TIME, THEREBY INCREASING THE LIKELIHOOD THAT CORROSION OF THE VAPORIZER'S METAL COMPONENTS WILL OCCUR.
ONE POINT OF SCISSORS BROKE OFF AND MIGRATED TO PT'S METACARPAL JOINT; THE OTHER POINT FRACTURED BUT REMAINED ATTACHED TO THE SCISSORS. ATTEMPTS TO RETRIEVE THE POINT WERE UNSUCCESSFUL; PER THE SURGEON, REMOVAL MAY BE NECESSARY IN THE FUTURE.
PLAINTIFF ALLEGES THAT SHE DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS CAUSED BY EXTENDED EXPOSURE TO LATEX GLOVES MADE BY CO, AS WELL AS, MANY OTHER GLOVE MFRS.
DATE SENT TO FDA: 11/7/96. B4 AND F8 DATE IS THE DATE THAT THIS INFO WAS RECEIVED BY CO. G4 DATE IS THE DATE THAT CO RECEIVED THIS INFO. H6 NA WAS USED DUE TO NO SAMPLE AND NO LOT NUMBER AVAILABLE FOR INVESTIGATION.
DURING THE IMPLANT OPERATION, A PROSTHETIC IMPLANT OPERATION, A PROSTHETIC MITRAL VALVE WAS EXPLANTED AND REPLACED BECAUSE OF A SUSPECTED LEAFLET DYSFUNCTION.
SECTION H6. METHOD CODE 86: DEVICE HISTORY REVIEW CONDUCTED AND MICROSCOPY PERFORMED. RESULTS CODE 100: LEAFLETS WERE FOUND TO MOVE FREELY. RESULTS CODE 300: MFG RECORDS REVIEW CONFIRMED DEVICE MET ALL MATERIAL, DIMENSIONAL AND PERFORMANCE REQUIREMENTS AT THE TIME OF THE MFR AND RELEASE.
PT HAD A FEEDING TUBE INSERTED IN 6/96. PT DEVELOPED HEMORRHAGIC ANEMIA DUE TO A BLEEDING ULCER IN OCT. THE ULCER WAS DIRECTLY ACROSS FROM THE TIP OF THE FEEDING TUBE.
WON'T ACTIVATE ALL THE TIME. PARTIALLY SEPARATED MOLDED PLUG.
CORRECTIVE ACTION WAS TAKEN TO PREVENT RECURRENCE OF MOLDED PLUG SEPARATION. MANUFACTURING INFORMED. THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 10/14/96. CO WAS UNABLE CONFIRM OR DUPLICATE THE REPORTED EVENT. IT WAS NOTED THAT THE MOLDED PLUG WAS PARTIALLY SEPARATED BUT WHEN PLACED TOGETHER PERFORMED AS INTENDED.
PLAINTIFF ALLEGES THAT HE DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS CAUSED BY EXTENDED EXPOSURE TO LATEX GLOVES MADE BY CO, AS WELL AS, MANY OTHER GLOVE MFRS.
ACCORDING TO THE PT, AFTER INFUSION DIFFICULTY ABOUT 12 MONTHS POST IMPLANT, CATHETER FRACTURE WITH EMBOLIZATION OF THE DISTAL SEGMENT TO THE PULMONARY ARTERY WAS DIAGNOSED AND THE SEGMENT SUCCESSFULLY RETRIEVED.
DESCRIBE EVENT OR PROBLEM. IMPLANT FRACTURED.
DR WAS SENT INVESTIGATION FORM. THE PERIAPICAL RADIOGRAPH DATED 11-14-94 SHOWED A 13MML 3.5MMD IMPLANT IN #13 AREA OF THE MAXILLA, SUPPORTING A ABUTMENT. THE PERIAPICAL RADIOGRAPH DATED 1-14-95 SHOWED THE 13MML IMPLANT IN THE #13 AREA, SUPPORTING A SINGLE CROWN, WITH WHAT APPEARED TO BE A FRACTURE AT THE COLLAR. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND THE PT COULD HAVE PLACED MORE FUNCTIONAL LOAD ON THE IMPLANT THAN WAS ANTICIPATED. THEREFORE, WHEN RESTORING THIS PT AGAIN, IT IS RECOMMENDED TO  REPLACE THE BROKEN IMPLANT WITH A WIDER ONE AND JOIN IT TO THE ADJACENT IMPLANTS FOR ADD'L SUPPORT.
PROBLEM FOUND ON 10/17 CXR SEVERED SEGMENT CATHETER REMOVED VIA RT FEMORAL VEIN FROM SVC/RT ATRIUM.
DATE SENT TO FDA: 11/7/96. B4 AND F8 IS THE DATE THAT THIS INFO WAS RECEIVED BY CO. G4 IS THE DATE THAT THIS INFO WAS RECEIVED BY CO. H6 NA WAS USED DUE TO NO SAMPLE AND NO LOT NUMBER AVAILABLE FOR INVESTIGATION.
THE DEVICE FAILED TO FIT ON THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME DUE TO THIS EVENT.
SUMMARY OF EVALUATION: THE EXAMINATION RESULTS INDICATE THAT WHEN DOWNWARDS PRESSURE ON THE INSERT WAS APPLIED, IT CURLED UP ON ITSELF AND JAMMED AGAINST THE SLOPED SURFACE OF THE METAL RETAINING FLANGE. IN THIS POSITION IT WOULD NOT ENGAGE CORRECTLY WITH THE BASEPLATE. AN UNDERSIZE CONDITION CONTRIBUTED TO THE ASSEMBLY PROBLEM.
DR WAS SENT INVESTIGATION FORM. IMPLANT THAT WAS INCLUDED WITH THIS REPORT WAS EXAMINED BY COS ENGINEERS. IT WAS DETERMINED THAT THE IMPLANT WAS FREE FROM ANY DEFECT AND IT MET ALL THE TOLERANCES NECESSARY TO COMPLY WITH MFR'S SPECIFICATIONS. THE PANORMAIC RADIOGRAPH DATED 7/24/96 SHOWED THE 16MML 3.7MMD IMPLANT IN THE #27 AREA OF THE MANDIBLE. AFTER STUDYING THE X-RAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
INITIAL SCOUT FILM FOR RADIOLOGY PROCEDURE SHOWS SEGMENT OF CATHETER LOCATED IN PT'S RUQ, PROBABLY RT KIDNEY.
IT WAS REPORTED THE EZ45B WAS USED DURING A THORACOTOMY WITH WEDGE RESECTION. THE DEVICE MISFIRED. ANOTHER WAS OPENED AND THE DEVICE WOULD NOT CLAMP DOWN ON TISSUE. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE.
A1,2,3,4;B3;D5;6,7;D5;6;H4; INFO UNAVAILABLE. SEE CORRESPONDENCE LOT: 10/10/1996 1550 ANOTHER RISK MGMT CALLED AND WILL TRY TO GATHER INFO AND CALL BACK.
PLAINTIFF ALLEGES THAT SHE DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPORATORY AND/OR OTHER RELATED DISEASES. DISORDERS AND REACTIONS CAUSED BY EXTENDED EXPOSURE TO LATEX GLOVES MADE BY CO, AS WELL AS, MANY OTHER GLOVE MFRS.
DR WAS SENT INVESTIGATION. THE PANORAMIC RADIOGRAPH DATED 4/21/96 SHOWED A 13MML 3.3MMD SCREW-VENT IMPLANT WAS PLACED IN THE #30 AREA OF THE MANDIBLE ON 3/14/96. THE IMPLANT FAILED TO OSSEOINTEGRATE AND WAS REMOVED ON 4/2/96. THE PANORAMIC RADIOGRAPH DATED 4/21/96 SHOWED A 13MML 3.3MMD IMPLANT IN THE # AREA OF THE MANDIBLE. AFTER STUDYING THE XRAYS AND REVIEWING REPORT, CO FOUND NO APPARENT FACTORS THAT WOULD HAVE PREVENTED THIS DENTAL IMPLANT FROM OSSEOINTEGRATING. EXTERNAL AND SYSTEMIC CAUSES LEADING TO IMPLANT FAILURE ARE REPORTED IN THE DENTAL LITERATURE, BUT THEY GO BEYOND THE FOCUS OF THIS INVESTIGATION.
HEALTHCARE PROFESSIONAL STATED VALVE WAS ABANDONED DURING IMPLANT DUE TO THE CLOTH COVERING DETACHING FROM THE ANNULUS OF THE BIOPROSTHESES AFTER PUTTING THE FIRST STITCHES IN THE PROSTHESES CLOSE TO THE RIGHT CORONARY CUSP.THE PT DID NOT EXPERIENCE ANY ADVERSE AFFECTS AND ANOTHER DEVICE WAS IMPLANTED.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED". DEVICE HISTORY REVIEW FOUND THAT THE PRODUCT MET SPEC WHEN RELEASED FOR CLINICAL USE. NO MEDWATCH FORM WAS REC'D FROM THE USER FACILITY THEREFORE, INFO ON THIS MEDWATCH FORM 3500A WAS COMPLETED BY CO WITH INFO REC'D FROM THE HEALTHCARE PROFESSIONAL. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY RPTR. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER. CO IS UNABLE TO COMPLETE FORM 3500A."  H3 ANALYSIS: THE DEVICE HISTORY INDICATE THAT THE VALVE MET ALL SPECS AT THE TIME IT WAS RELEASED FOR CLINICAL USE. ANALYSIS OF THE PRODUCT AS RETURNED SHOW A TEAR IN THE MYOCARDIAL TISSUE ALONG THE SUTURE LINE. THE TEAR WAS LIKELY CAUSED BY HANDLING PROCEDURES DURING IMPLANT. NEEDLE HOLES WHERE OBSERVED IN THE CLOTH COVER.
DURING TESTING, SCREEN AND RECORDER DISPLAY SQUARE WAVE SIGNAL AND HEARTRATE OF 108BPM AT POWER-UP. NO PT INVOLVEMENT. CURRENTLY AWAITING RETURN OF DEVICE FOR ANALYSIS.
VERIFIED COMPLAINT IN PADDLE MODE ONLY. PROBLEM IS INTERMITTENT. FOUND CAPACITOR C 57 ON ANALOG BOARD TO BE PHYSICALLY DAMAGED; UNIT HAD BEEN DROPPED. RECORDER DOOR LATCH BROKEN. REPLACED C 57 AND LATCH. UNIT FUNCTIONS CORRECTLY.
DURING TESTING, UNIT WILL NOT CHARGE AND DISPLAYS ERROR CODE 001. MONITORING/PACING FUNCTIONS ARE OPERATIONAL. NO PT INVOLVEMENT. AWAITING RETURN OF DEVICE FOR ANALYSIS.
EVALUATION SUMMARY: VERIFIED. FOUND DIODE D3 ON HIGH VOLTAGE BOARD SHORTED AND LOWER CASE BROKEN. REPLACED DIODE D3 AND LOWER CASE. UNIT FUNCTIONS CORRECTLY. CO DOES NOT CONSIDER THIS DOCUMENT OR ITS CONTENTS TO BE AN ADMISSION THAT A DEVICE IS DEFECTIVE OR THAT A DEVICE HAS CAUSED A DEATH OR SERIOUS INJURY. THIS DOCUMENT CONTAINS CONFIDENTIAL OR PROPRIETARY INFORMATION. NEITHER THIS DOCUMENT NOR THE INFORMATION THEREIN IS TO BE REPRODUCED, DISTRIBUTED, USED OR DISCLOSED, EITHER IN WHOLE OR IN PART, EXCEPT AS SPECIFICALLY AUTHORIZED BY CO.
PLAINTIFF ALLEGED THAT SHE DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS CAUSED BY EXTENDED EXPOSURE TO LATEX GLOVES MADE BY CO, AS WELL AS, MANY OTHER GLOVE MFRS.
DATE SENT TO FDA: 11/7/96. B4 AND F8 IS THE DATE THAT THIS INFO WAS RECEIVED BY CO. G4 IS THE DATE THAT HIS INFO WAS RECEIVED BY CO. H6 NA WAS USED DUE TO NO SAMPLE AND NO LOT NUMBER AVAILABLE FOR INVESTIGATION.
AFTER MINIMAL CONTACT WITH THE TEETH THE TRACHEAL CUFF WAS TORN. THIS OCCURRED ON TWO ENDOBRONCHIAL TUBES DURING INTUBATION. NO PT INJURY.
CODE 68: SINCE THE REPORT SAMPLE WAS NOT RETURNED AND NO LOT NUMBER PROVIDED, NO TESTING OF THE LOT COULD BE PERFORMED. THIS SITUATION MAY HAVE BEEN CAUSED BY THE TRACHEAL CUFF BEING SCUFFED AGAINST THE TEETH DURIN INTUBATION. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "NO", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? NO. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "NO", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A CO DEVICE IS DEFECTIVE OR HAD MALFUNCTIONED OR THAT A CO DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. WHEN STAPLING THE MESH DURING THE CASE THE DEVICE JAMMED AND WAS RENDERED USELESS. ANOTHER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "JAMMED AND WAS RENDERED USELESS" DURING SURGERY MAY HAVE BEEN DUE TO A MISPOSITIONED STAPLE IN THE CARTRIDGE STAPLE TRACK WHICH CAUSED THE INSTRUMENT TO JAM. THE INSTRUMENT WAS REC'D WITH A YIELDED CRIMP AND THERE WERE 2 STAPLES JAMMED IN THE FRONT OF THE STAPLE TRACK. THE FRONT STAPLE HAD BECOME MISPOSITIONED UNDER THE DRIVER CAUSING THE INSTRUMENT TO JAM AND THE SUBSEQUENT YIELDING OF THE CRIMP UPON THE REFIRING OF THE INSTRUMENT. THE INSTRUMENT WAS DISASSEMBLED AND THE TUBE WAS OBSERVED TO HAVE BEEN SUFFICIENTLY CRIMPED. THE CARTRIDGE CONTAINED 14 STAPLES. IT WAS CONCLUDED THAT THE MISPOSITIONED STAPLE IN THE CARTRIDGE TRACK HAD CAUSED THE TUBE CRIMP TO YIELD. NO CONCLUSION COULD BE REACHED AS TO HOW THE STAPLE HAD BECOME MISPOSITIONED IN THE CARTRIDGE TRACK. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. THE INSTRUMENT'S STAPLES MAY BECOME TWISTED AND MISPOSITIONED WITHIN THE CARTRIDGE TRACK AND NOSE IF THE INSTRUMENT SUSTAINS A BLUNT TRAUMA. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
ON APPROX 8/6/96, THE PT GREW OUT BACILIUS SPECIES FROM A CENTRAL VENOUS CATHETER. PT PLACED ON A 7 DAY COURSE OF ANTIBIOTICS. PT READMITTED ON 8/16/96 AND HAD THE CATHETER REMOVED DUE TO POSITIVE BLOOD CULTURES WHILE ON ANTIBIOTICS. PT HAD ANOTHER CENTRAL VENOUS CATHETER PLACED ON 8/20/96. IT APPEARS THE HOSP AND THE SUBSEQUENT HOME HEALTH CARE AGENCY USED ANOTHER MFR'S IV TUBING WITH THE CATHETER. WHEN THE PT WAS ADMITTED TO THE HOSP ON 7/25/96 ANOTHER MFR'S VALVE WAS USED. THESE TWO PRODUCTS WERE UNDERSTOOD TO BE INTERCHANGEABLE WHEN USED WITH THIS CO'S CATHETER. HOWEVER, IT APPEARS THE OTHER MFR'S TUBING STRETCHED THE CATHETER CAUSING THE LEAKAGE TO OCCUR AT THE LOCK CAP WHEN THE OTHER MFR'S VALVE WAS USED.
DURING TESTING, SCREEN AND RECORDER DISPLAY SQUARE WAVE FORM AND HEARTRATE OF 108 BPM AT POWER-UP. NO PT INVOLEMENT.
EVAL SUMMARY: FOUND PROBLEM TO BE INTERMITTENT AND VIBRATION SENSITIVE, OCCURRING ONLY IN PADDLE MODE. FOUND CHIP CAPACITOR ON ANALOG BOARD TO BE CHANGING VALVE. REPLACED C57. UNIT FUNCTIONS CORRECTLY. CO DOES NOT CONSIDER THIS DOCUMENT OR ITS CONTENTS TO BE AN ADMISSION THAT A CO PRODUCT IS DEFECTIVE OR THAT A CO HAS CAUSED OR DEATH OR SERIOUS INJURY. THIS DOCUMENT CONTAINS CONFIDENTIAL OR PROPRIETARY INFO OF CO. NEITHER THIS DOCUMENT NOR THE INFO THEREIN IS TO BE REPRODUCED, DISTRIBUTED, USED OR DISCLOSED, EITHER IN WHOLE OR IN PART, EXCEPT AS SPECIFICALLY AUTHORIZED BY CO.
PLAINTIFF ALLEGES THAT SHE DEVELOPED SEVERE ILNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS CAUSED BY EXTENDED EXPOSURE TO LATEX GLOVES MADE BY CO, AS WELL AS, MANY OTHER GLOVE MFRS.
DEVICE RETURNED BY PHYSICIAN FOR ANALYSIS WITH REPORT OF "NO INFUSION SUSPECTED." DEVICE IS UNDERGOING ANALYSIS.
TRIED TO DEFIB THE PT WITH EXTERNAL PADDLES, DID DISCHARGE, BUT STAFF SAID THAT THE DELIVERED ENERGY COULD NOT HAVE BEEN WHAT THE UNIT WAS SET AT. OPENED PT UP FURTHER AND USED INTERNAL PADDLES WHICH DID NOT DISCHARGE. TRIED NEW CABLE WITH SAME RESULTS. USED ANOTHER DEFIB WHICH WORKED FINE.
UNIT WAS LAST SERVICED BY HOSPITAL'S BIO-MED ON 9/18/96, THE DAY BEFORE THE INCIDENT. AFTER THE INCIDENT THE UNIT WAS INSPECTED BY CO. PIN 3 ON EXTERNAL PADDLE SET WAS PUSHED IN: CORRESPONDING CONNECTOR ON DEFIB IS DAMAGED. THE UNIT WAS TESTED BY CO'S AND HOSP BIO-MED. BIO-MED INDICATES THAT ONE TIME THE DEFIB DID NOT DISCHARGE AT THE 2 JOULES SETTING, BUT WORKED AFTERWARD. FOUND NOTHING ABNORMAL WITH THE FUNCTIONALITY OF THE UNIT. CONNECTOR WAS OBVIOUSLY DAMAGED; IN SWAPPING THE PADDLESETS. THE FEMALE CONNECTOR ON THE DEFIB WAS DAMAGED WORSE AND CONTACT WAS NOT MADE TO ENABLE THE DISCHARGE BUTTONS TO OPERATE. PT CARE WAS NOT ADVERSELY AFFECTED BECAUSE ANOTHER DEFIB WAS USED SUCCESSFULLY WITHOUT A SIGNIFICANT DELAY. THE PT SURVIVED. UNIT IS IN THE BIO-MED SHOP AND HAS NOT BEEN USED SINCE THE INCIDENT. THE DEFIB WILL NOT BE REPAIRED. IT IS BEING RETIRED AND REPLACED WITH A NEW UNIT THAT ARRIVED AROUND THE TIME OF THE INCIDENT.
THE END USER HOSP REPORTED THAT DURING AN INJECTION INTO A PT'S LEFT CORONARY ARTERY, AIR WAS SEEN TO GO DOWN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. ON INSPECTION OF THE MANIFOLD USED IN THE INJECTION, A CRACK WAS NOTED. THE MANIFOLD WAS CHANGED AND THE CASE COMPLETED. NO COMPLICATIONS WERE INCURRED AS A RESULT OF THIS INCIDENT.
VISUAL EXAM REVEALED A CRACKED HANDLE IN THE MANIFOLD. THIS HAS BEEN DETERMINED TO HAVE BEEN CAUSED BY THE HANDLE NOT BEING SEATED PROPERLY DURING ASSEMBLY. THE FIXTURE AT THE WORK STATION WHERE THE HANDLE IS SEATED DURING THE ASSEMBLY PROCESS HAS BEEN RE-DESIGNED TO CREATE AN IMPROVED ALIGNMENT OF THE COMPONENTS.
DEVICE IMPLANTED IN PT IN ANOTHER COUNTRY. LIMITED INFO RECEIVED. PHYSICIAN REPORTED "UNDER INFUSION AND STOPPED WORKING" REQUESTED THAT DEVICE BE ANALYZED.
USER ENCOUNTERED DIFFICULTY IN REMOVING PROTECTIVE LINER. PADS PEELED APART WHEN USER WAS UNABLE TO REMOVE LINER.
ELECTRODES RETURNED TO MFG FOR EVAL. EVAL CONFIRMED THAT INITIAL LINER RELEASE WAS DIFFICULT. CORRECTIVE ACTION IN PLACE.
PLAINTIFF ALLEGES THAT SHE DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS CAUSED BY EXTENDED EXPOSURE TO LATEX GLOVES MADE BY CO, AS WELL AS, MAY OTHER GLOVE MFGS.
DATE SENT TO FDA: 11/7/96. B4 AND F8 DATE IS THE DATE THAT THIS INFO WAS RECEIVED BY CO. G4 IS THE DATHE THAT THIS INFO WAS RECEIVED BY CO. H6 NA WAS USED DUE TO NO SAMPLE AND NO LOT NUMBER AVAILABLE FOR INVESTIGATION.
PT INFO NOT AVAILABLE FROM EUROPEAN SOURCE. DR REPORTED THAT "ROTOR STALLED 20 DEGREE TURN TEST TRIED NO MOVEMENT". REPLACED DEVICE WITH NEW PUMP.
PT INFO NOT AVAILABLE FROM EUROPEAN SOURCE. DR REPORTED THAT "ROTOR STALLED 20 DEGREE TURN TEST TRIED NO MOVEMENT" REPLACED DEVICE WITH NEW PUMP.
A 46-YR-OLD WHITE MALE HAD PREVIOUSLY HAD CHEMOTHERAPY THROUGH A RIGHT SUBCLAVIAN CATHETER. DURING HIS VISIT TO THE OUTPATIENT CENTER THE DAY PRIOR TO SURGERY, HE HAD HEPARIN FLUSHED INTO THE CATHETER AND A POP WAS HEARD. THE PT WENT TO THE X-RAY DEPT WHERE IT WAS FOUND THAT HE HAD A FRAGMENT APPROX 6-8 CM LONG. THE CATHETER HAD BROKEN AND HAD GONE INTO THE RIGHT SIDE OF THE HEART UNDER THE PULMONARY VASCULATURE. THE CARDIOTHORACIC PERSONNEL WERE CONSULTED AND IT WAS NOTED THAT THERE WAS NO EMERGENCY BUT RADIOLOGY FELT THAT AN EXTRACTION WAS REASONABLY SAFE AND POSSIBLE TO BE PERFORMED. THROUGH A RIGHT FEMORAL APPROACH, THEY ATTEMPTED TO PULL THE CATHETER DOWN AND WERE SUCCESSFUL IN GETTING IT INTO THE RIGHT ILIAC VEIN BUT THE GRASPER SLIPPED OFF THE CATHETER AND THE CATHETER WAS NOW IN THE RIGHT ILIAC VEIN. THE PT WAS TAKEN TO THE OR AND A RIGHT FEMORAL EXPLORATION WAS THEN PERFORMED. AFTER HAVING CONTROL OF ALL AREAS, THE INTRODUCER CATHETER WAS PULLED OUT AND NO FRAGMENT AND CATHETER WAS NOTED. VIA X-RAY THE CATHETER WAS FOUND IN THE RIGHT ILIAC VEIN. WITH THE FINGER ON THE CATHETER, A STONE FORCEPS WAS PASSED UP THROUGH THE FEMORAL VEIN. THE CATHETER WAS THEN GRABBED WITH THE STONE FORCEPS AND PULLED OUT THROUGH THE FEMORAL VEIN APPROACH. A CATHETER WAS PASSED AND A LARGE THROMBUS WAS REMOVED FROM THE RIGHT ILIAC VEIN. PREPARATION WAS PERFORMED TO PLACE A RIGHT IJ SUPERIOR VENA CAVA FILTER TO PREVENT ANY CLOT FROM REACHING THE PULMONARY VASCULATURE SYSTEM. WHILE PREPARING FOR THIS, THE CATHETER IN THE RIGHT SUBCLAVIAN WAS REMOVED. THE FILTER WAS PLACED IN THE INTRODUCER, FLUSHED WITH HEPARINIZED SALINE AND THEN WAS FIRED UNDER FLUOROSCOPIC GUIDANCE WITH GOOD NORMAL DEPLOYMENT. PT WAS EXTUBATED AND TAKEN TO THE ICU IN STABLE CONDITION WHERE HE DID WELL.
IT HAS BEEN REPORTED THAT AN ABUTMENT SCREW FRACTURED INSIDE AN IMPLANT. THE SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT. THE IMPLANT IS STILL IN THE PT'S MOUTH. PT INJURY HAS NOT BEEN REPORTED.
UNATTACHED FIXTURE THAT FRACTURED CAUSED BIOMECHANICAL OVERLOAD OF THIS COMPONENT.
DURING SHOULDER SURGERY HEAD OF BUR BROKE OFF SHARK AND FELL INTO THE PT. DOCTOR REPORTED HE HAD RETRIEVED ALL PRICES. NO COMPLICATION OR INJURY REPORTED.
DEVICE RETURNED BY PHYSICIAN FOR ANALYSIS WITH REPORT OF "ROTOR STALL". REGISTRATION INDICATED MORPHINE BEING ADMINSTERED. DEVICE UNDERGOING ANALYSIS.
4/9/1998: G9 - MFR REPORT NUMBER HAS BEEN CORRECTED HERE AND IN HEADER ON PAGE 1. PRIMARY FINDING OF DEVICE ANALYSIS REVEALED MOTOR COIL ANOMALY. CORRECTION NUMBER INCLUDED FOR THIS DEVICE.
THE PHYSICIAN WAS DRILLING FOR PLACEMENT OF SCREW IN THE MEDIAL TIBIA OF A FRACTURED RIGHT ANKLE WHEN THE DRILL BIT BROKE, AND BECAME EMBEDDED IN THE TIBIA WHERE IT REMAINED.
SEE ATTACHED DISCLAIMER". "SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFO WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT".
PRODUCT CODE UNK, LOT NUMBER UNK, PLAINTIFF REPORTS AS OF 1977 WHEN SHE BECAME A MEDICAL TECHNOLOGIST SHE BEGAN EXPERIENCING HAND SORES, HIVES, WHEEZING, HAND DERMATITIS, RUNNY NOSE, OCCUPATIONAL ASTHMA, UNEXPLAINED RASHES ON HER BODY AND RAPID HEARTBEAT. SHE WAS DIAGNOSED WITH TYPE 1 LATEX ALLERGY ON 10/20/95.
DATE SENT TO FDA: 11/7/96. B4 AND F8 DATE IS THE DATE THAT CO BECAME AWARE OF THIS LAWSUIT. G4 IS THE DATE THAT CO BECAME AWARE OF THIS LAWSUIT. H6 NA WAS USED DUE TO NO SAMPLE AND NO LOT NUMBER AVAILABLE FOR INVESTIGATION.
FACILITY ALLEGES A BLOOD LEAK OCCURRED AT THE END OF TREATMENT. DIALYSIS WAS DISCONTINUED AND THE BLOOD WAS NOT RETURNED TO THE PT. ESTIMATED BLOOD LOSS 200CC'S. BLOOD LOSS WAS DUE TO THE BLOOD LEFT IN THE DIALYZER AND BLOOD LINES WHEN DISCARDED. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS INCIDENT. THIS EVENT INVOLVED ONE PT.
F3-MFR/DISTRIBUTOR IS THE SAME. F13-THIS IS BEING REPORTED AS A MFR NOT AS A DISTRIBUTOR. F10-PT CODE 2200-BLOOD LOSS.
THE PENCIL, AFTER STERILIZATION , ACTS LIKE A "POWER PENCIL" CAUSING SPONTANEOUS POWER INCREASE AT THE MOMENT OF CONNECTION.
THE INCIDENT SAMPLE WAS TESTED AND TO BE NON-FUNCTIONAL IN BOTH THE CUT AND COAG MODES; THE CUSTOMERS REPORT OF "SPONTANEOUS POWER INCREASE" WAS NOT DUPLICATED. THE INTERNAL SWITCHING MECHANISM WAS EXAMINED AND DISCOLORATION AND CORROSION WAS FOUND. CLARIFICATION OF THE REPROCESSING INSTRUCTIONS HAS TAKEN PLACE TO IMPROVE THE RELIABILITY OF THE PENCIL.
DEVICE SPONTANEOUSLY TURNS OFF DURING OPERATION. NO ALARMS PRIOR TO SHUTDOWN. NO PT IMPACT.
EVENT CODE-2199-NA. 1475 NOT LABELED. ALL SECTIONS ON THIS FORM COMPLETED BY THE MFR. THE MONITOR WAS RETURNED TO THE CO'S SERVICE CENTER FOR EVALUATION. A VISUAL INSPECTION DID NOT REVEAL ANY POSSIBLE CAUSES FOR THE REPORTED INCIDENT. THE MONITOR WAS CONNECTED TO THE CUSTOMER'S PRINTER MODULE AND ALLOWED TO RUN FOR OVER 90 HOURS ON AC POWER USING THE CUSTOMER'S POWER CORD. REPEATED POWER CYCLING (OFF/ON) OF THE MONITOR WAS ALSO PERFORMED. THE UNIT OPERATED PROPERLY AND NO INCIDENT OF TURNING OFF, LOCKING UP, OR RESETTING WAS NOTED. THE MONITOR WAS THEN DISASSEMBLED AND EXAMINED FOR ANY INDICATIONS OF A POSSIBLE CAUSE. NONE WERE NOTED. THE CUSTOMER'S REPORT COULD NOT BE VERIFIED OR DUPLICATED, THOUGH FUNCTIONAL TESTING WAS PERFORMED AND THE MONITOR OPERATED TO SPEC FOR THIS MODEL. AN ELECTRICAL TEST FAILURE FOR THE PT TEMPERATURE CIRCUITRY WAS SEEN, HOWEVER IT WAS NOT RELATED TO THE CUSTOMER'S REPORTED SYMPTOMS. NO SPECIFIC CORRECTIVE ACTION IS PLANNED AS NO PRODUCT ISSUES WERE FOUND RELATED TO THE REPORT. STATISTICAL PROCESS CONTROL (SPC) DATA WILL BE REVIEWED REGULARLY TO DETERMINE IF SIGNIFICANT TRENDS ARE IDENTIFIED RELATED TO THIS REPORT. IF SIGNIFICANT TRENDS ARE IDENTIFIED, A SEPARATE INVESTIGATION WILL BE INITIATED.
PRODUCT CODE UNK, LOT NUMBER UNK, "PLAINTIFF SUFERED PHYSICAL INJURY AND DAMAGE AND HAS CONTRACTED SEVERE AND IRREVERSIBLE TYPE 1 LATEX ALLERGY, WHICH IS BELIEVED TO BE PERMANENT AND LIFE-THREATENING."
DATE SENT TO FDA: 11/7/96. B4 AND F8 DATE IS THE DATE THAT THIS INFO WAS RECEIVED BY A CO'S EMPLOYEE. G4 DATE IS THE DATE THAT THE CO RECEIVED THIS INFO. H6 NA WAS USED DUE TO NO SAMPLE AND NO LOT NUMBER AVAILABLE FOR INVESTIGATION.
PLAINTIFF ALLEGES THAT HE DEVELOPED SEVERE ILLNESSES AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS CAUSED BY EXTENDED EXPOSURE TO LATEX GLOVES MADE BY CO, AS WELL AS, MANY OTHER GLOVE MFRS.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVALUATION. THE ITEM WAS USED. THE FILE IS CONSIDERED CLOSED. ANY ADD'L INFO RECIEVED BY CO WILL BE REPORTED.
ON 11/7/96 CO WAS INFORMED THAT THE USER DID NOT UNSCREW THE HEMOSTASIS VALVE FROM THE DILATOR. IT WAS OBSERVED THAT THE VALVE WAS NOT TIGHTLY SCREWED TO THE SHEATH HUB WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. ONCE THE VALVE WAS TIGHTENED, THERE WAS NO FURTHER PROBLEM AND THE DEVICE WAS USED.
F3-MFR/DISTRIBUTOR IS THE SAME. F13-THIS IS BEING REPORTED AS A MFR MOT AS A DISTRIBUTOR. F10-PT CODE 2200-BLOOD LOSS.
PHYSICIAN REPORTED PT WAS OVERMEDICATED DUE TO A PROGRAMMING ERROR. DOSE WAS PROGRAMMED TO MCG/KG DAY INSTEAD OF MCG/DAY. PT SEDATED BUT EASILY AROUSABLE. RECOVERED WITHOUT INCIDENT. VOMITING OCCURRED DURING THE EVENT BUT WAS THOUGHT TO BE DUE TO CONCOMITANT USE OF MORPHINE.
ADD'L INFO REQUESTED-PT IS A STUDY PARTICIPANT.
PT HAD IMPLANTATION OF INFLATABLE PENILE PROSTHESIS IN 1993. HAD MALFUNCTION REQUIRING 2 REVISIONS AT THAT TIME. NOW PRESENTS WITH EROSION OF CYLINDER THROUGH CORPUS CAVERNOSA, THROUGH BUCKS FASCIA AND INTO THE URETHRA. PROSTHESIS WAS REMOVED UNDER GENERAL ANESTHESIA. REPORTED BY PHONE TO MFR AT TIME OF PROCEDURE.
FACILITY ALLEGES A BLOOD LEAK OCCURRED DURING TREATMENT. DIALYSIS WAS DISCONTINUED AND THE BLOOD WAS NOT RETURNED TO THE PT. ESTIMATED BLOOD LOSS WAS DUE TO BLOOD LEFT IN THE DIALYZER AND BLOOD LINES WHEN DISCARDED. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS EVENT. THIS EVENT INVOLVED ONE PT.
WHEN REMOVING GROUND PAD A 3CM-5CM AREA ON POSTERIOR THIGH WAS OBSERVED TO HAVE BEEN BURNED.
BUTTON WAS IMPLANTED IN 7/95 AND SEPARATED ON 9/19/96. THE DEVICE WAS SEPARATED INTO TWO PIECES, WHICH HAD TO BE REMOVED BY THE PHYSICIAN. CO WAS INFORMED OF THIS EVENT ON 10/9/96.
THE CUSTOMER REPORTED TO CO THAT THEY HAD PENCILS TO RETURN BECAUSE THEY WERE "NOT WORKING PROPERLY". DURING TESTING, ONE OF THE RETURNED PENCILS WAS FOUND TO SELF-ACTIVATE.
THE PENCIL WAS FOUND TO SELF-ACTIVATE DURING TESTING FOR 2 SECONDS DURING TESTING. A MATERIAL CHANGE TO THE CLIPS IN THE INTERNAL SWITCHING MECHANISM HAS TAKEN PLACE TO PREVENT FLUID INGRESS IN THE SWITCHING AREA. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18 USC-1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONDIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
SINCE ITS FIRST USE, EVERY TIME THE UNIT WAS UNPLUGGED FROM THE POWER SUPPLY AND THEN PLUGGED BACK IN, IT WOULD START BEEPING AND DISPLAY THE WRONG DATE. AFTER THE DATE WAS RESET IT WOULD STOP BEEPING BUT THE DISPLAY WOULD READ RTC-CLOCK AND DISPLAY A WRENCH SYMBOL. THE MANUAL INDICATES THAT BOTH ARE WARNING INDICATORS. TO EVALUATE THE UNIT, THE LEADS WERE ATTACHED TO THE DEVICE TESTING UNIT SET TO THE DEFIB SETTING. THE UNIT POWERED UP TO SHOCK BUT THE SHOCK COULD NOT BE DELIVERED BY PRESSING THE BUTTON. AFTER A SHORT PERIOD OF TIME (LESS THAN 1 MINUTE:), A CLICK WAS HEARD AND THEN THE UNIT BECAME UNRESPONSIVE (COULD NOT BE POWERED OFF). SINCE THAT TIME, THE DISPLAY SHOWS A SOLID SET OF BARS AND IS STILL COMPLETELY UNRESPONSIVE".
SUMMARY OF DEVICE EVALUATION: THE RETURNED DEVICE WAS EVALUATED BY A SERVICE TECHNICIAN WHO COULD NOT DUPLICATE THE REPORTED COMPLAINT. THE DEVICE WAS THOROUGHLY TESTED TO ALL DEVICE SPECIFICATIONS AND WAS FOUND TO BE FULLY COMPLIANT, OPERATING NORMALLY THROUGH ALL TESTS COMPLETED.
FACILITY ALLEGES AN ADVERSE REACTION OCCURRED TWENTY MINUTES AFTER THE START OF DIALYSIS WITH DIALYZER. PT DISCOMFORT AND TACHYPNEA REPORTED. PT WAS GIVEN URBASON 20 MG. DIALYSIS WAS DISCONTINUED AND THE BLOOD IN THE DIALYZER AND BLOODLINES WAS NOT RETURNED TO THE PT. ESTIMATED BLOOD LOSS UNKNOWN. NO SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT. THIS EVENT INVOLVED ONE PT.
THE DR THREADED THE GUIDE WIRE THROUGH THE GUIDE CATHETER BUT WAS UNABLE TO SEE THE PLATINUM TIP. WHEN THE GUIDE WIRE WAS REMOVED, IT BECAME APPARENT THAT THE SPRING TIP WAS MISSING. THE GUIDING CATHETER WAS BACK FLUSHED, HOWEVER, AND THE PHYSICIAN WAS UNABLE TO LOCATE THE SPRING TIP. THE DR INDICATED THE SPRING TIP MAY HAVE LODGED IN THE GUIDE WIRE INSERTION TOOL.
THE DISTAL END OF THE GUIDE WIRE APPEARS TO HAVE BEEN RESTRAINED WHILE ATTEMPTING TO PASS THROUGH THE GUIDING CATHETER CAUSING THE WIRE TO BEND AND THEN FRACTURE.
THE DEVICE WAS USED DURING A PELVISCOPY. THE DEVICE MELTED THE TROCAR AND THE REDUCER CAP OF ANOTHER CO'S 5MM TROCAR. A BURN ABOUT 6 1/2" X 1" RECTANGULAR IN SHAPE AND AN OVAL BLISTER ABOUT 1/8" X 1/4" INFERIOR TO THE TROCAR WERE NOTICED AT THE END OF THE CASE. IT IS UNK IF OTHER ELECTROSURGERY DEVICES WERE USED THROUGH THE TROCAR. IT IS UNK IF ANY INTERVENTION WAS PERFORMED. THE REP IS RETURNING THE TROCAR WITH THE DEVICE. 10/23/96 IT WAS REPORTED THE REP SPOKE TO THE SURGEON AND HE WAS CONCERNED BURN MIGHT HAVE BURNED THE CANNULA ALSO. A PLASTIC SURGEON IS LOOKING AT THE PT'S BURNS.
THE CUSTOMER REPORTED TO CO THAT THEY HAD PENCILS TO RETURN BECAUSE THEY WERE "NOT WORKING PROPERLY". DURING TESTING, TWO AT THE RETURNED PENCILS WERE FOUND TO SELF-ACTIVATE.
TWO OF THE PENCILS THAT WERE RETURNED WERE FOUND TO SELFACTIVATE DURING TESTING FOR 2 TO 3 SECONDS. A MATERIAL CHANGE TO THE CLIPS IN THE INTERNAL SWITCHING MECHANISM HAS TAKEN PLACE TO PREVENT FLUID INGRESS IN THE SWITCHING AREA. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AND ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
THE PENCIL, AFTER STERILIZATION, ACTS LIKE A "POWER PENCIL" CAUSING SPONTANEOUS POWER INCREASE AT THE MOMENT OF CONNECTION.
THE INCIDENT SAMPLE WAS INSPECTED AND THE PROTECTIVE OVERMOLDING COVERING THE INTERNAL SWITCHING MECHANISM WAS TORN A WAY. THE TAPE COVERING THE SEITCHING MECHANISM HAD BEEN REMOVED. ALTHOUGH IT APPEARED THE SWITCHING MECHANSIM HAD BEEN TAMPERED WITH, THE PENCIL PASSED ALL FUNCTIONAL AND ELECTRICAL TESTS.
REVISION SURGERY REVESLED LOOSENING OF THE TIBIAL BASEPLATE.
SUMMARY OF EVALUATION: THE TIBIAL BASEPLATE CAN NOT BE EVALUATED FOR THE REPORTED LOSS OF FIXATION AS IT HAS NOT BEEN RETURNED TO CO BUT RATHER HAS BEEN RETAINED BY THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS BASEPLATE FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. USER FACILITY INFORMATION WAS REQUESTED FOR SECTION F AND IS UNOBTAINABLE.
FACILITY ALLEGES AN ADVERSE REACTION OCCURRED TWENTY-FIVE MINUTES AFTER THE START OF DIALYSIS WITH DIALYZER. PT DISCOMFORT AND TACHYPNEA REPORTED. PT WAS GIVEN URBASON 20MG. DIALYSIS WAS DISCONTINUED AND THE BLOOD IN THE DIALYZER AND BLOODLINES WAS NOT RETURNED TO THE PT. ESTIMATED BLOOD LOSS UNKNOWN. NO SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT. THIS EVENT INVOLVED ONE PT.
A REPORT WAS RECEIVED OF AN ENDOSSEOUS DENTAL IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION.
86=DIMENSIONAL ANALYSIS, 100=VISUAL EXAM SHOWED TOOL MARKS ON THE COLLAR OF THE IMPLANT, MOST LIKELY DUE TO THE REMOVAL PROCEDURE. THE RETURNED COMPONENT MET CO DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
FACILITY ALLEGES AN ADVERSE REACTION OCCURRED FIFTEEN MINUTES AFTER THE START OF DIALYSIS WITH DIALYZER. PT SYMPTOMS WERE A NON-PRODUCTIVE COUGH AND INTERNAL DYSPNEA. PT WAS GIVEN OXYGEN AND URBASON 40MG. DIALYSIS WAS DISCONTINUED AND THE BLOOD IN THE DIALYZER AND BLOODLINE WAS NOT RETURNED TO THE PT. ESTIMATED BLOOD LOSS UNKNOWN. NO SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT. THIS EVENT INVOLVED ONE PT.
EVAL CODES FOR SECTION H6: 100 THERE IS CONSIDERABLE DAMAGE PRESENT IN THE WEIGHT BEARING AREA. THERE IS UNUSUAL WEAR OR COLD FLOW PATTERN.
THE PT UNDERWENT A LAPAROSCOPIC APPENDECTOMY. WHEN THE TROCAR WAS INSERTED, BOTH ILIAC ARTERIES WERE LACERATED. IT IS SUSPECTED THAT THE SAFETY SHIELD DID NOT DEPLOY PROPERLY. THE PROCEDURE WAS CONVERTED TO OPEN, AND THE PT REQUIRED TRANSFER TO ANOTHER FACILITY AND REQUIRED ANOTHER SURGICAL PROCEDURE TO CORRECT VASCULAR DEFECTS.
11/6/96 SUBMISSION OF INITIAL REPORT TO FDA BY MFR.
CUSTOMER STATES THAT THE MONITOR DID NOT REGISTER RESPIRATION SIGNALS WHEN HOOKED TO A PT. CUSTOMER STATES THAT THE MONITOR DID NOT ALARM OR SHOW AN ALARM CONDITION AT ANY TIME DURING "A COUPLE OF MINUTES" OF THIS CONDITION. CUSTOMER ALSO STATES THAT SHE FAILED TO GET THE UNIT TO ALARM FOR SLOW HEART RATE.
THE MFR PERFORMED A COMPLETE FUNCTIONAL TEST ON THE SUSPECTED MONITOR. THERE WERE NO DEFICIENCIES IN PERFORMANCE FOUND.
THE PHYSICIAN PLACED A FEEDING TUBE SUCCESSFULLY. IT WAS NOTED APPROX. SIX WEEKS LATER THAT THE G-TUBE ADAPTER HAD DETACHED FROM THE SIDE BODY ADAPTER. THE FEEDING TUBE WAS REMOVED AND REPLACED. NO OTHER INFO IS AVAILABLE.
THIS REPORT IS BASED ENTIRELY ON UNCONFIRMED INFO SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENDED TO BE AN ADMISSION THAT ANY WILSON-COOK DEVICE (I) IS DEFECTIVE OR MALFUNCTIONED OR (II) CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. CO DOES NOT BELIEVE THAT THIS REPORTED INCIDENT IS LIKELY TO RECUR. THE RED G-TUBE ADAPTER DETACHED FROM THE SIDE PORT BODY. THE GLUE JOINT AT THE G-TUBE AND SIDE PORT BODY FAILED. A NEW MECHANICAL FIT DESIGN HAS REPLACED THE GLUED STYLE.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT CAME LOOSE AND PT LOST IMPLANT AND CROWN. LOOKED LIKE IT WAS INFECTED.
METHOD (86): PART WAS NOT RETURNED. LOT NUMBER NOT AVAILABLE FROM MD'S OFFICE.
FACILITY ALLEGES AN ADVERSE REACTION OCCURRED AT THE START OF DIALYSIS ON DIALYZER. PT DISCOMFORT AND HYPOTENSION REPORTED. DIALYSIS WAS DISCONTINUED AND THE BLOOD IN THE DIALYZER AND BLOODLINES WAS NOT RETURNED TO THE PT. ESTIMATED BLOOD LOSS 190CC'S. DIALYSIS WAS RESTARTED WITH ANOTHER DIALYZER WITH NO FURTHER PROBLEMS REPORTED. NO SERIOUS INJURY REPORTED AS A RESULT OF THIS EVENT. THIS EVENT INVOLVED ONE PT.
RISK MGR REPORTED, PT WAS FOUND WITHOUT RESPIRATIONS-FULL CARDIOPULMONARY ARREST, AND CPR WAS INITIATED, RESUSCITATOR WAS OBTAINED FROM CODE CART AND OBSERVED TO BE MISSING MASK. THE COMPLAINANT STATED, THE STAFF MEMBER CALLED TO THE CODE REPORTED THE BLUE TAPE ON POLYBAGGED RESUSCITATOR WAS PRESENT, PRIOR TO REMOVING UNIT FOR USE.
CO HAS NOT BEEN ABLE TO OBTAIN ANY ADD'L INFO FROM THE COMPLAINANT REGARDING INCIDENT. ALL COMMUNICATIONS TO DATE HAS BEEN FROM THEIR LEGAL STAFF. CO CAN NOT DETERMINE HOW LONG PT MAY HAVE BEEN WITHOUT A PULSE AND THE TRUE IMPACT OF THE DELAYED ATTEMPT TO RESUSCITATE THE PT. A FOLLOW-UP REPORT WILL BE SUBMITTED BY 11/15/96 WITH CO'S AACTION PLAN TO ASSURE MASKS ARE PRESENT IN ALL BAGS.
A MES TECH EXAMINED THE MACHINE AND REPLACED THE UF PUMP THERMAL FUSE. NO PART WAS RECEIVED BY THE MFR FOR INVESTIGATION. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC S/N MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART HAS NOT BEEN RECEIVED FOR INVESTIGATION AS OF THE TIME OF THIS REPORT. IT HAS BEEN SEEN ON PREVIOUS INVESTIGATIONS THAT A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES FUSE TO OPEN. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. A REVIEW OF THE COMPLAINT HISTORY FOR THIS SPECIFIC S/N MACHINE ON 11/5/96 SHOWS THAT THERE HAVE BEEN NO FURTHER OCCURRENCES OF THIS NATURE, INDICATING THAT THE CONDITION WAS CORRECTED BY THE ACTION TAKEN. TO HELP DETECT UF PUMP THERMAL FUSE FAILURES AND TO VERIFY THE UF SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A HUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE UF RATE IS AS EXPECTED, HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE UF RATE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. CUSTOMER CONTACTED: N. SALES/SVC CONTACTED BY INVESTIGATOR N. TRAINING REQUIRED N. REPORT ATTACHED. N.
THE DEVICE WAS USED DURING A LUNG RESECTION PROCEDURE. THE INSTRUMENT CUT BUT DID NOT STAPLE. THE HOSP HAS REPORTED BLOOD LOSS OCCURRED. HOWEVER, A TRANSFUSION WAS NOT REQUIRED. THE SURGEON APPLIED CLAMPS AND SUTURED TO CONTROL THE BLEEDING.
DENTAL IASSISTANT REPORTED THAT AN IMPLANT FAILED DUE TO TRAUMATIC AVULSION.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. CO FOUND THE IMPLANT TO ACTUALLY BE A (0801) 8MM IMPLANT INSTEAD OF THE (0611) 15MM IMPLANT ORIGINALLY REPORTED. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE MD'S OFFICE.
FACILITY ALLEGES AN ADVERSE REACTION OCCURRED DURING DIALYSIS WITH DIALYZER. PT SYMPTOMS WERE BRONCHOSPASMS, DYSPNEA, AND TACHYPNEA. PT WAS GIVEN OXYGEN AND URBASON 40MG. DIALYSIS WAS DISCONTINUED AND THE BLOOD IN THE DIALYZER AND BLOODLINES WAS NOT RETURNED TO THE PT. ESTIMATED BLOOD LOSS-150CC'S. NO SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT. THIS EVENT INVOLVED ONE PT.
ONE IMPLANT PLACED 3/28/96. REMOVED 10/10/96. PT PREVIOUSLY HAD CHEMOTHERAPY FOR CANCER, BUT NO RECENT PROBLEMS HEALTHWISE. ONE PERSON AFFECTED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. THE PT'S HEALING CAPABILITIES HAVE LIKELY BEEN COMPROMISED BY THE CANCER, WHICH IS THE LIKELY CAUSE OF FAILURE.
THE PT WAS BEING FED USING AN ENTERAL PUMP. 640 ML OF AN ENTERAL FEEDING SOLUTION WERE HUNG, AND THE PUMP WAS SET TO DELIVER 68 ML/HR. THE PT RECEIVED 640 ML IN LESS THAN 60 MINUTES. THE PT HAD A FEVER AND VOMITTED. THE PT WAS SUCTIONED. THE PHYSICIAN WAS CALLED, BUT DID NOT SEE THE PT. ONE PT INVOLVED.
1499-UNABLE TO IDENTIFY THIS CODE. 1635-NOT LABELED-THIS DEVICE HAS NO TIMER. CO'S STANDARD PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE RPTR FOR COMPLETION AND RETURN. IN THIS CASE, THE RPTR DID NOT PROVIDE THE REQUIRED INFO FOR THE FOLLOWING SECTIONS: D10 AND F2. D9 & H3-THE DEVICE WAS GIVEN TO THE MFR'S REPRESENTATIVE ON 10/08. IT IS NOW IN THE HANDS OF THE DME, AND HAS NOT YET BEEN RETURNED TO THE MFR FOR EVALUATION.
THE DEVICE WAS USED DURING A BULLECTOMY PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED DUE TO PERIO INVOLVEMENT AND BONE LOSS.
PT COMPLAINED OF PAIN. ARTHROSCOPY WAS PERFORMED AND A DIVOT WAS NOTICED IN THE ARTICULATING SURFACE. DEVICE WAS REMOVED AND REPLACED.
EVALUATION CODES FOR SECTION H6: 100 THE SURFACE HAS CONSIDERABLE DAMAGE AND WEAR OR COLD FLOW PRESENT. IS THE FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "N", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO IF "N", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
DURING A BONE BIOPSY OF THE RIGHT TIBIA, THE BIOPSY CANNULA TIP BROKE APART. THE SURGEON RETRIEVED THREE PIECES OF THE CANNULA. HOWEVER, THE CANNULA STILL APPEARED INCOMPLETE. AN X-RAY WAS OBTAINED BUT REVEALED NO APPARENT REMAINING PIECES IN THE PT.
10/14/96 THE CANNULA HAD BEEN THROWN AWAY. EVAL SUMMARY: THE SAMPLE WAS NOT RECEIVED AT THE FACILITY FOR AN EVAL. A DEVICE HISTORY REVIEW FROM 8/95 THROUGH 10/31/96, REVEALED NO SIMILAR DISCREPANCIES. A COMPLAINT HISTORY REVIEW WAS ALSO PERFORMED FROM 11/92 - 10/31/96, AND NO SIMILAR COMPLAINTS HAVE BEEN REPORTED. THE OS500-005, CANNULA IS PART OF THE VERTEBRAL BIOPSY SET. THE COMPLAINT TEXT RECEIVED INDICATES THAT THE CANNULA WAS USED DURING A RIGHT TIBIA BONE BIOPSY. THE PRODUCT WAS NOT USED FOR ITS INTENDED USE.
THE DEVICE WAS APPLIED DURING A RIGHT LOWER LOBECTOMY. REPORTEDLY, THE SEVERAL STAPLES DID NOT FORM. THE SURGEON APPLIED SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP. THAT THE SAFETY DID NOT ACTIVATE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,; B6,7; D10; INFO NOT PROVIDED BY AFFILIATE. D5,6; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
LETTER FROM ATTY STATES THAT NEEDLE BREAKAGE OCCURRED WHILE CLOSING FASCIA FOLLOWING LAPAROSCOPIC CHOLECYSTECTOMY. FRAGMENT FELL INTO OPEN INCISION, X-RAYS WERE TAKEN, BUT FRAGMENT WAS NOT ABLE TO BE LOCATED OR RETRIEVED AND PT IS ALLEGING "EMOTIONAL TURMOIL" AS A RESULT.
MFR'S REPORT DATE 4/24/97. THE DEVICE WAS RETURNED TO THE MFR. VISUAL EXAMINATION REVEALED THE LATEX Y-SITE INJECTION PORT HAD DETACHED FROM THE Y-SITE. NUMEROUS SCRAPES AND GOUGES WERE FOUND INSIDE THE FLUID PATH WALL OF THE Y-SITE INDICATING THAT THE NEEDLE DEVICE USED TO INSERT INTO THE Y-SITE PAD HAD BEEN INSERTED AT AN ANGLE INSTEAD OF THE PAD'S CENTER RING. THE LATEX PAD WAS NOT RETURNED WITH THE DEVICE. NUMEROUS OFF-CENTERED INSERTIONS INTO THE LATEX PAD CAN CAUSE THIS TYPE OF DETACHMENT. INSERVICING HAS BEEN PERFORMED ON THE PROPER TECHNIQUE FOR INSERTING A NEEDLE DEVICE INTO THE LATEX INJECTION PORT. THIS REPORT WAS FILLED OUT BY THE MFR.
IT WAS REPORTED THAT DURING AN INFUSION OF DOPAMINE, ON A DOPAMINE DEPENDANT PATIENT, THE SET CAME APART AT THE INJECTION PORT. THE DOPAMINE LEAKED OUT OF THE PORT AND ONTO THE FLOOR INSTEAD OF INFUSION INTO PATIENT. THE PATIENT'S BLOOD PRESSURE DROPPED TO 38 OVER 0 AND WITHIN A FEW MINUTES, ALMOST CODED. NURSE ADMINISTERED AN INJECTION OF DOPAMINE TO STABILIZE BLOOD PRESSURE THEN CHANGED IV TUBING AND RESTARTED A NEW INFUSION. PATIENT REMAINED STABILIZED WITH NO FURTHER COMPLICATIONS.
DR REPORTED THAT A PT PRESENTED WITH LOOSE IMPLANT, NO EVIDENCE OF SUPPORTING BONE, CHRONICALLY INFECTED, PT HAS SEEN HER GP ON REGULAR VISITS, IMPLANT WAS LOADED WITH TWO UNIT BRIDGE. #29-30. DR ELECTED TO REMOVE THE IMPLANT. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORT #M385914 AND MEDWATCH REPORT 2023141-1996-00225.
A FISTULAGRAM WAS IN PROGRESS; ANGIOPLASTY BEING PERFORMED; ADVANCED BALLOON THROUGH SHEATH; BROKE OFF AT HUB; SHEATH AND BALLOON ENTERED FISTULA BUT WERE PULLED OUT.
WHILE ATTEMPTING TO REMOVE A BLOOD CULTURE BOTTLE FROM INSTRUMENT, THE BOTTLE BROKE. THIS RESULTED IN A CUT TO THE OPERATOR'S LEFT INDEX FINGER, REQUIRING MEDICAL INTERVENTION (6 STITCHES). PT WAS PUT ON ORAL DYSOXICILLIN (OXICILLIN) DUE TO THE STAPH THAT WAS GROWING. DUE TO THE BOTTLE BREAK THERE IS NO BLOOD AVAILABLE TO DO A FINAL ID OF THE STAPH. THIS TREATMENT WAS BASED ON THE GRAM STAIN RESULTS. THE CUSTOMER IS EMPLOYED AS A FULL TIME MEDICAL TECHNOLOGIST IN THE LAB. THE INCIDENT HAPPENED AT 6:25 AM. THE PT WHOSE BOTTLE BROKE IS AN END STAGE CARCINOMA PT. THERE IS BLOOD DRAWN TO DO AN INFECTIOUS DISEASE WORK UP, HBSZAB, HIV, HTLV. NO RESULTS.
FREQUENCY OF OCCURRENCE STATEMENT (21 CFR 803.24(C)(7)). THE PACKAGE INSERT AND INSTRUMENT OPERATOR'S MANUAL CONTAIN PRECAUTIONS CONCERNING POTENTIAL FOR GLASS BREAKAGE AND PRECAUTIONS FOR HANDLING POTENTIALLY INFECTIOUS BODY FLUIDS. EXPECTED FREQUENCY OF CUTS RESULTING FROM BREAKAGE OF THE GLASS BOTTLE ARE NOT SPECIFICALLY ADDRESSED IN THE PRODUCT LABELING. CO BELIEVES THAT THE FREQUENCY AT THE TIME OF THIS REPORT IS NOT GREATER THAN IS USUAL FOR THE DEVICE. SEVERITY OF OCCURRENCE STATEMENT (21 CFR 803.24(C)(7)). THE PACKAGE INSERT AND INSTRUMENT OPERATOR'S MANUAL CONTAIN PRECAUTIONS CONCERNING POTENTIAL FOR GLASS BREAKAGE AND PRECAUTIONS FOR HANDLING POTENTIALLY INFECTIOUS BODY FLUIDS. THE DEGREE OF SEVERITY OF CUTS RESULTING FROM GLASS BOTTLE BREAKAGE IS NOT SPECIFICALLY ADDRESSED IN THE PRODUCT LABELING. CO BELIEVES THE DEGREE OF SEVERITY OF THIS INCIDENT IS NOT GREATER THAN WOULD BE EXPECTED FOR THE DEVICE.
SQUEEZE BOTTLE RUPTURED ALLOWING HEATED GEL TO SQUIRT OUT ON PT. POTENTIAL FOR BURN INJURY.
THE SQUEEZE BOTTLE IS MADE OF LOW DENSITY POLYETHYLENE, PROVIDING A FLEXIBLE, SQUEEZABLE CONTAINER. THE SPILITY AT THE BOTTOM OF THIS DISPENSER INDICATES THAT IT MAY HAVE BEEN DROPPED ONTO A HARD SURFACE, CAUSING IT TO CRACK AND THEN TO SPLIT OPEN WHEN SQUEEZED. IT IS UNSUAL TO OBSERVE THIS TYPE OF SPLITTING OR CRACKING WITH THIS MATERIAL. IT IS VERY UNLIKELY THAT THE ULTRASOUND GEL WOULD BE SO HOT AS TO POTENTIALLY BURN A PT WITHOUT THE HEALTH PROFESSIONAL WHO IS APPLYING THE GEL BEING AWARE OF IT; THE OUTSIDE OF THE DISPENSER BOTTLE WOULD BE HOT TO THE TOUCH. THEREFORE, ANY RECURRENCE OF THIS INCIDENT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY.
REPORTER HAS "DECLINED" TO PROVIDE ANY ADD'L INFO NOT PREVIOUSLY LISTED ON FORM 3500. REPORTER WAS INFORMED THAT IF THE PRODUCT WAS RETURNED FOR EVALUATION CO WOULD GUARANTEE NOT TO PERFORM ANY DESTRUCTIVE TESTING. REPORTER "DECLINED" TO RETURN PRODUCT. MFR COMPLETED THE FOLLOWING SECTIONS: A1, A4, B2, D6, D7, ALL SECTION F,E4. H6-REPORTER DECLINED TO EXPLAIN PROBLEM ENCOUNTERED WITH SYSTEM.
IMPLANT PLACED 5/9/96. DR HAD A HEALING ABUTMENT IN PLACE. DISCOVERED THAT THE IMPLANT DID NOT INTEGRATE. IT WAS REMOVED 10/10/96.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES WERE INVOLVED, HAS BEEN RECEIVED. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
FIVE DAYS FOLLOWING HYSTERECTOMY PROCEDURE, SUTURE BREAKGE OCCURRED CAUSING EVISCERATION WHICH REQUIRED RE-OP TO REPAIR.
DR REPORTED THAT A PT PRESENTED WITH LOOSE IMPLANTS, NO EVIDENCE OF SUPPORTING BONE, CHRONICALLY INFECTED. PT HAS SEEN HER GP ON REGULAR VISITS, IMPLANT WAS LOADED WITH TWO UNIT BRIDGE, #29-3-. DR ELECTED TO REMOVE THE IMPLANT. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORT #M385914 AND MEDWATCH REPORT 2023141-1996-00224.
THE HANDPIECE WAS INVOLVED IN A CORNEAL BURN HOWEVER IT IS NOT KNOWN WHETHER THE EVENT WAS RELATED TO THE DR'S TECHNIQUE OR THE HANDPIECE. THE DR WAS USING HIGH MACHINE SETTINGS. PT STATUS IS NOT KNOWN.
H3: EVALUATION SUMMARY: MECHANICAL AND FUNCTIONAL TESTS WERE PERFORMED ON THE HANDPIECE AND IT WAS FOUND TO BE FUNCTIONING WITHIN ITS SPECIFICATION. NO ANOMALIES WERE NOTED IN THE HANDPIECE THAT WOULD HAVE CONTRIBUTED TO THE CORNEAL BURN.
86=DIMENSIONAL ANALYSIS. 100=VISUAL EXAMINATION SHOWED BONE TISSUE MATTER IN THE BASKET OF THE IMPLANT, THEREFORE, A COMPLETE DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED. THE RETURNED COMPONENT MET THE REMAINING INTERPORE VISUAL AND DIMENSIONAL SPECIFICATIONS.
PT BROUGHT TO O.R. FOR REMOVAL OF PORTION OF CATHETER FROM BLADDER. PT WAS AT HOME WHEN CATHETER BROKE. WENT TO UROLOGIST OFFICE FOR FOLLOW-UP. INSERTED ON 8/7/96. UROLOGIST FELT CATHETER BROKE BECAUSE OF CONSTANT WEIGHT OF PTS PANNICULUS ON CATHETER IN SAME PLACE - FINALLY BROKE.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED. PT IS REPORTEDLY FINE.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738.
THE IAB WOULD NOT INFLATE. NO OTHER INFO WAS AVAILABLE FROM THE CONTACT. ON 11/5/96, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED BY THE FACILITY AND WOULD NOT BE RETURNED FOR EVALUATION. EVENT COMPLICATIONS: UNK - REPORTED 10/4/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 10/4/96.
DURING A DIALYSIS TREATMENT, THE FACILITY NOTICED THAT THE VENOUS PRESSURE WOULD NOT MOVE FROM ZERO. A BROKEN BLOOD PUMP ROTOR SPRING WAS FOUND. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD. THE MES FOUND A BROKEN BLOOD PUMP ROTOR SPRING AND REPLACED IT WITH A NEW ROTOR. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE BLOOD PUMP ROTOR WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE THE MES DISCARDED THE DEFECTIVE ASSEMBLY. HOWEVER, COMPLAINTS (0896290C3, 0996032C3, 0996181C3, 0996199C3, 1096026CE) SHOW THAT ROTOR SPRINGS DO BREAK. INDICATIONS ARE THE SAME AS THIS REPORTED CONDITION. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW. THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND/OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET. IF UNDETECTED, A BROKEN ROTOR SPRING CAN RESULT IN A LESS EFFICIENT DIALYSIS FOR THE PT. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATM PRESSURE. A PUNCTURE ON THE VENOUS SIDE COULD RESULT IN BLOOD LOSS AND POSSIBLE BLOOD CONTAMINATION. THIS ALARM GENERATES A VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE ABOVE INFO INDICATES THAT THE DIFFICULTIES THE FACILITY HAD WITH THE VENOUS PRESSURE AS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM, ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED: N. SALE/SVC CONTACTED BY INVESTIGATOR: N. TRAINING REQIRED: N. REPORT ATTACHED: N.
AFTER IABP FOR FIVE DAYS, CHECK "IAB CATH" AND GAS LOSS" ALARMS SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE CATHETER. THE IAB WAS REMOVED SURGICALLY WITHIN ONE HR.
UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WEHN THE BALLOON IS SUBJECTED TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY. THE PHYSICAL EVIDENCE AND REPORTED PROBLEM ARE CONSISTANT WITH THAT OF AN IAB WHICH BECAME ENTRAPPED AND WAS SURGICALLY REMOVED FROM THE PATIENT. THE SMOOTH-EDGED PENETRATION(S) MOST LIKELY RESULTED WHEN THE BALLOON MEMBRANE CAME IN CONTACT WITH A SHARP-EDGED INSTRUMENT DURING THE REMOVAL PROCESS. ALTHOUGH THE PATIENT CONSEQUENCES OF BALLOON PENETRATION REMAIN OVERWHELMINGLY BENIGN, GENERALLY NECESSITATING ONLY THE REMOVAL OF THE BALLOON AND ITS POSSIBLE REPLACEMENT, THE MEDICAL COMMUNITY IS BECOMING INCREASINGLY AWARE OF THE "ENTRAPPED BALLOON" PHENOMENON. SINCE IT IS POSSIBLE FOR A SMALL LEAK TO BE SELF LIMITING, THE BLOOD WITHIN THE BALLOON MAY DEHYDRATE UNDER THE CONTINUED ACTION OF HELIUM TO FORM A HARD CLOT DURING INTRA-AORTIC BALLOON PUMPING, BEFORE ENOUGH BLOOD ENTERS TO BECOME VISIBLE IN THE CATHETER. THIS CLOT MAY PREVENT PERCUTANEOUS REMOVAL OF THE BALLOON CAUSING IT TO BECOME "ENTRAPPED" IN THE ARTERY. BALLOON ENTRAPMENT NECESSITATING SURGICAL REMOVAL HAS BEEN REPORTED IN LITERATURE AND HAS BEEN EXPERIENCED BY USERS OF INTRA-AORTIC BALLOONS. CO THEREFORE URGE THE USER, AS CO HAS DONE IN CO'S INSTRUCTIONS, TO DISCONTINUE PUMPING AND CONSIDER THE REMOVAL OF THE BALLOON FROM THE PATIENT AT ONCE IF A BALLOON LEAK IS SUSPECTED. IF FOR ANY REASON, UNDUE RESISTANCE IS MET DURING REMOVAL OF THE BALLOON, THE USER WOULD BE WELL ADVISED TO CALL FOR A VASCULAR CONSULTATION, AS WAS DONE IN THIS CASE.
DURING LAPAROSCOPIC BURCH PROCEDURE, NEEDLE BREAKAGE OCCURRED. NO X-RAYS WERE TAKEN AND SURGERY WAS NOT EXTENDED BEYOND 5-10 MINUTES IN EFFORT TO LOCATE AND RETRIEVE NEEDLE WHICH EFFORT WAS NOT SUCCESSFUL. PT IS NOW ALLEGING BACK PAIN.
ONE LARGE BODY PIECE, INCLUDING THE BARREL, OF THE ACTUAL NEEDLE WAS EXAMMINED USING SCANNING ELECTRON MICROSCOPE. SEM PHOTOGRAPHS OF NEEDLE WIRE SURFACE, FRACTURE SURFACE, AND HIGH MAGNIFICATION VIEW DEPICTING THE MODE OF FRACTURE. IT WAS CONCLUDED THAT THE NEEDLE FRACTURED IN A DUCTILE MANNER DUE TO TENSILE OVERLOAD IN THE PRESENCE OF A SHARP NOTCH. THE NEEDLE WAS BENT BACK AS MUCH AS 60 DEGREES BEFORE FRACTURE. THERE WERE NO SIGNS OF MATERIAL OR MANUFACTURING DEFECTS.
THE IAB LEAKED. AS A RESULT OF THE EVENT, THE PATIENT NEEDED TO GO TO THE O.R. TO HAVE THE IAB SURGICALLY REMOVED. THERE WAS TRAUMA TO THE PATIENT'S ARTERY. ON 11/1/96, DATASCOPE WAS NOTIFIED BY THE CONTACT IN THE RISK MANAGEMENT DEPT. AT THE FACILITY THAT THEY WERE UNABLE TO LOCATE THE IAB. THEY REPORTED THAT THE IAB WAS PROBABLY DISCARDED. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 11/26/96; THE PROCEDURE WAS PTCA AND LCX WITH STENT AND IABP PLACEMENT. THE PATIENT DEVELOPED LEFT GROIN HEMATOMA AT IABP SITE ON 10/7/96 AND WENT TO THE O.R. FOR IABP REMOVAL AND EXPLORATION OF LEFT FEMORAL ARTERY WITH REPAIR OF THE LEFT FEMORAL ARTERY. THE PATIENT NEEDED A TRANSFUSION. THE PATIENT WAS POST OP LEFT AND RIGHT HEART CARDIAC CATHETER ON 10/3/96. THE PATIENT DID WELL POST OP WITH NO REOCCURENCE OF CHEST PAIN. THE PATIENT WAS DISCHARGED ON 10/13/96 AFTER A VASCULAR CONSULT WITH MEDICAL THERAPY. EVENT COMPLICATIONS: THE IAB WAS SURGICALLY REMOVED - REPORTED 10/9/96 AND 11/26/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 10/9/96.
SIX IMPLANTS WERE PLACED ON 5/28/96 FOR AN OVERDENTURE. ONE IMPLANT FELL OUT 9/22/96. THE RESTORING DENTIST PLACED A DENTURE TOO SOON ON TISSUE IMPLANTS AND HE USED A HARD ACRYLIC REBASE. (THE IMPLANT HAD BEEN UNCOVERED ON 8/29/95 AND IT WAS FINE.) THE OTHER 5 IMPLANTS ARE FINE. ONE PERSON AFFECTED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECS. THE REPORTED EARLY LOADING IS THE PROBABLE CAUSE OF FAILURE-INTEGRATION COULD NOT TAKE PLACE DUE TO ALL OF THE FORCES BEING PLACED UPON THE IMPLANT.
LAB OWNER REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. HE THINKS IT WAS OVERLOADED AND PROBABLY CAME LOOSE WITHOUT PT BEING AWARE OF IT.
METHOD (86): PART NOT RETURNED. LOT NUJMBER NOT AVAILABLE FROM LAB.
PT WAS ONE-MONTH POST-OP CORONARY ARTERY BYPASS GRAFT. WAS ADMITTED FOR SUDDEN ONSET OF RIGHT-SIDED HEMIPARESIS & GLOBAL ESTHESIA. PT HAD FLUCTUATING MENTAL STATUS. HEAD CT SHOWED OLD INFARCT, FRONTAL LOBE TRAUMA, AND EARLY CVA. THE PT WAS IN THE ICU - A LOUD CRASH WAS HEARD AND THE PT WAS FOUND ON THE FLOOR - RAIL FELL OFF. (WHEN PT WAS CHECKED 15 MINUTES EARLIER BED RAILS WERE UP.) THE PIN THAT HOLDS THE BED RAIL LOCK IN PLACE WAS FOUND ON THE FLOOR BY THE DOORWAY. PT HAD HIT SUPRA-ORBITAL RIDGE, BUT THERE WERE NO MENTAL STATE CHANGES AFTER THE FALL WITH NO OBVIOUS INJURIES SUBSEQUENT FROM THE FALL. PT DIED 3 DAYS LATER FROM UNRELATED HEART CONDITION.
THE PT WAS IMPLANTED WITH ADJUSTABLE PROSTHESIS ON 12/3/93. SUBSEQUENTLY DURING A POST-OP FILLING SCHEDULE THE TUBING BROKE OFF DEVICE AT THE WRONG POINT. NO ADD'L INFO REGARDING THIS OCCURRENCE THE PHYSICIAN NOTED IS AVAILABLE AT THIS TIME. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (CO EFFECTIVE DATE, 2/10/92). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21 CFR 803.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY; MENTOR H/S EXPRESSLY DENIES THAT ANY INFORMATION CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION."
DURING A ROUTINE PM (PRE-MAINTENANCE), A BROKEN BLOOD PUMP ROTOR SPRING WAS FOUND. THERE WAS NO PT INVOLVEMENT.
THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD. THE MES FOUND A BROKEN BLOOD PUMP ROTOR SPRING DURING A PM AND REPLACED IT WITH A NEW ROTOR. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED.  THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE BLOOD PUMP ROTOR WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE THE MES DISCARDED THE DEFECTIVE ASSEMBLY. HOWEVER, NO COMPLAINTS (0896290C3, 0996032C3, 0996181C3, 1096026C3) SHOW THAT THE ROTOR SPRINGS DO BREAK. THE INDICATIONS ARE THE SAME AS THIS REPORTED CONDITION. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW. THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND/OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET. IF UNDETECTED, A BROKEN ROTOR SPRING CAN RESULT IN A LESS EFFICIENT DIALYSIS  FOR THE PT. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATMOSPHERIC PRESSURE. A PUNCTURE ON THE VENOUS SIDE COULD RESULT IN BLOOD LOSS CONTAMINATION. THIS ALARM GENERATES A VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE ABOVE INFO INDICATES THAT THE PM FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. CUSTOMER CONTACTED: N. SALES/SVC CONTACTED BY INVESTIGATOR: N. TRAINING REQUIRED: N. REPORT ATTACHED: N.
ON 7/27/96, THE PT'S FEEDING TUBE WAS FOUND CONNECTED TO THE OXYGEN TUBING FOR HIS NASAL CANNULA. THE PT'S ABDOMEN WAS DISTENDED AND HE COMPLAINED OF PAIN. A SHORT TIME LATER, THE PT BECAME UNRESPONSIVE, WAS CODED AND TRANSFERRED TO ICU. X-RAYS CONFIRMED FREE AIR IN THE ABDOMEN AND A PERFORATION OF THE COLON, SUBSEQUENTLY, A COLOSTOMY AND A GASTROSTOMY TUBE WERE PLACED. THE PT DEVELOPED SEPSIS AND HIS CONDITION DETERIORATED. THE PT EXPIRED ON 8/20/96. THE REPORTER WAS UNSURE HOW THE CONNECTION BETWEEN THE NG TUBE  AND THE OXYGEN TUBING WAS MADE, ALTHOUGH THEY SUSPECT THE PT (WHO WAS DISORIENTED) MAY HAVE PULLED THE NG TUBE OUT, TRIED TO RECONNECT IT, AND CONNECTED IT INCORRECTLY. THE PHYSICIANS ARE UNSURE IF THE AMOUNT OF AIR THAT WAS PUT INTO THE PT COULD HAVE CAUSED THE COLON TO PERFORATE. ONE PT INVOLVED.
MFG EVENT ID: RPIC 60324. EVENT CODES: 2001-NOT LABELED. 2067-NOT LABELED. 1802 -NOT LABELED. 1399-NOT LABELED.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. EVALUATION SUMMARY: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
WHEN THE IAB WAS RETURNED TO DATASCOPE FOR EVALUATION, IT WAS REPORTED THAT THE PATIENT WAS IN CRITICAL CONDITION (MULTIPLE IV DRIPS, DIALYSIS, COAGULPATHIES) CONTRARY TO WHAT WAS INITIALLY REPORTED (PATIENT DEATH ON 10/3/96). EVENT COMPLICATIONS: UNK - REPORTED 10/9/96 AND 10/31/96. PATIENT CURRENT STATUS: CRITICAL - RPT'D 10/31/96.
LAWSUIT ALLEGES THAT INFECTION DEVELOPED FOLLOWING BREAST AUGMENTATION PROCEDURE REQUIRING RE-OP RO REMOVE BREAST IMPLANTS.
H7 - THIS PRODUCT ALLEGED TO HAVE BEEN PART OF A PRODUCT RECALL IN 1994 WHICH HAS BEEN REPORTED IN A PORDUCT LIABILITY LITIGATION RECEIVED ON 10/21/96.
EVAL CODE 81 HAS BEEN USED BECAUSE THE INCIDENT OCCURRED IN FEB 1996 BUT CO WAS NOT NOTIFIED UNTIL SEPT 1996, AND THE SERIAL NUMBER OF THE UNIT IS UNK. SUBMISSION OF INFO BY STRYKER UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN  PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FOIA.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738
THE IAB LEAKED. THAT WAS THE ONLY INFO AVAILABLE FROM THE CONTACT. ON 1/17/97, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. EVENT COMPLICATIONS: UNK - REPORTED 10/10/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 10/10/96.
INFECTION; RE-OP TO REMOVE BREAST IMPLANTS.
H7-THIS PRODUCT ALLEGED TO HAVE BEEN PART OF A PRODUCT RECALL IN 1994 WHICH HAS BEEN REPORTED IN PRODUCT LIABILITY LITIGATION RECEIVED ON 10/21/96.
LAB OWNER REPORTED THAT AN ABUTM4ENT BROKE IN FUNCITON. PT IS REPORTEDLY FINE.
DR REPORTED THAT 3 IMPLANTS, PLACED 9/6/96, HAD FAILED AND WERE REMOVED 10/5/96. THE PT COMPLAINED OF PAIN AND SWELLING. THE DR PUT THE IMPLANTS UNDER FUNCTION.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE 3 RETURNED IMPLANTS WERE EVALUATED. THEY HAD YELLOWISH RESIDUE ON THE EXTERNAL SURFACES AND MET SPECS. THE PROBABLE CAUSE OF FAILURE IS THE REPORTED INFECTION.
THE DR CLAIMS THAT THE GRAFT LEAKED APPROX 300CC OF BLOOD. THE DR APPLIED SUCTION AND THE BLEEDING EVENTUALLY STOPPED. THE PT IS FINE AND UNHARMED.
SINCE THE GRAFT APPEARS TO HAVE BEEN LEFT IN THE PT AND WAS NOT AVAILABLE FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. A RETURNED, UNUSED SECTION OF THE ABOVE REFERENCED GRAFT WAS EVALUATED BY CO'S CONSULTING PATHOLOGIST. A COPY OF THAT REPORT IS ATTACHED. GROSS DESCRIPTION: RECEIVED FRESH IS A SEGMENT OF VASCULAR GRAFT MEASURING 5.0 CM IN LENGTH BY 2.0 CM IN DIAMETER. NO TISSUE IS IDENTIFIED. NO BLOOD COMPONENTS OR THROMBOSIS ARE IDENTIFIED. MICROSCOPIC DESCRIPTION: A SEGMENT OF VASCULAR GRAFT WITH COATING IS IDENTIFIED. NO LOSS OF INTEGRITY OF THE COATING IS NOTED ON THE LUMINAL SURFACE, WITHIN THE INTERSTICES, OR ON THE PERADVENTITIAL (OUTER) SURFACE OF THE VASCULAR GRAFT. NO BLOOD COMPONENTS, TISSUE COMPONENTS OR THROMBOSIS ARE IDENTIFIED. SUMMARY: A SEGMENT OF VASCULAR GRAFT WITH INTACT COATING IS IDENTIFIED.
ON 10/16/96, THE FACILITY OR INVENTORY MGR CONTACTED A MFR REPRESENTATIVE AND REPORTED THAT THE PT HAD BEEN SCHEDULED FOR SURGERY AND UPON OPENING THE DEVICE PACKAGE IN THE OR, THE DEVICE J-WIRE WAS DISCOVERED TO BE CRACKED. ANOTHER DEVICE WAS NOT AVAILABLE TO COMPLETE THE SURGERY. AS A RESULT, THE SURGERY WAS CANCELED AND A NEW DEVICE ORDERED FOR SURGERY AT A LATER DATE.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: INITIAL VISUAL EXAM REVEALED THAT THE GUIDEWIRE WAS KINKED AT THE DISTAL END, AT THE BEGINNING OF THE J-TIP CURVE. MICROSCOPIC EXAM CONFIRMED THAT THE GUIDEWIRE WAS KINKED AT THE DAMAGED AREA, AT THE BASE OF THE J-TIP CURVE, AT THE DISTAL END. VISUAL INSPECTION OF THE 76CM GUIDEWIRE, AFTER IT WAS REMOVED FROM ITS PLASTIC SHEATH AND J-TIP STRAIGHTENER, ALSO REVEALED A BEND IN THE GUIDEWIRE APPROX. THREE INCHES FROM THE DISTAL END. THE GUIDEWIRE WAS NOT "KINKED" IN THIS AREA. NO OTHER DEFECTS OR ANOMALIES WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY AND MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. A KINK IN THE DEVICE HAS BEEN CONFIRMED; HOWEVER, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
SINCE ONLY THE SCREW WAS RETURNED TO CO A COMPLETE EVALUATION OF THE DIFFICULTIES WAS NOT POSSIBLE. CO FOUND NO OBSERVABLE DEFECTS WITH THE SCREW PORTION OF THE ABUTMENT. A REVIEW OF THE PRODUCT'S HISTORY WAS COMPLETED AND WAS FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
ON 10/2, THE PT. A IDDM, BEGAIN OBTAINING READINGS OF 32 MG/DL ON HER METER. BASED UPON THESE READINGS, SHE DID NOT TAKE HER INSULIN AND ATE "SUGAR" AS ADVISED BY HER PHYSICIAN. SHE CONTINUED A PATTERN OF TESTING AND EATING THROUGHOUT THE DAY, CONINUALLY OBTAINING A READING OF 32 MG/DL ON HER METER. WHEN SHE BECAME WEAK AND FAINT, SHE WENT TO THE "CARE CLINIC" WHERE A BLOOD GLUCOSE RESUT OF 410 ON A CLINIC METER (BRAND UNK) WAS OBTAINED. SAMPLE SENT TO THE LAB AT THE SAME TIME WAS 550 MG/DL. SHE REFUSED TO BE HOSPITALIZED AS SUGGESTED AND WAS GIVEN AN INJECTION OF INSULIN AND SENT HOME AT 7/P WITH INSTRUCTIONS TO TAKE AN ADDITIONAL 10 UNITS NPH. THE METER IS NOT CLEANED CORRECTLY. CONTROL SOLUTION IS USED TO CLEAN THE METER OPTICS ONCE EVERY TWO WEEKS. NO QUALITY CONTROL TESTS HAVE BEEN PERFORMED. CALIBRATION STATUS IS UNK AT THIS TIME. THE PT STORES THE TEST STRIPS OUTSIDE OF THE VIAL IN THE METER CASE, A PRACTICE WHICH IS WARNED AGAINST IN THE PRODUCT'S PACKAGE INSERT.  CARE
CO IS UNABLE TO COMPLETE ITS INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE DUE TO THE FACT THAT THE METER WAS NOT RETURNED TO LIFESCAN. THEREFORE, CO HAS NOT BEEN ABLE TO EVALUATE THE METER TO DETERMINE WHETHER OR NOT A DEVICE MALFUNCTION MAY HAVE CONTRIBUTED TO THIS EVENT. BATCH RECORD REVIEW WAS ATTEMPTED, HOWEVER, THE REPORTED SERIAL NUMBER DOES NOT APPEAR TO BE VALID. AT THIS POINT CO CONSIDERS THIS MATTER CLOSED.
SUMMONS & COMPLAINT STATES THAT FOLLOWING BREAST SURGERY TO REMOVE SILICONE IMPLANTS, PT'S INCISIONS BECAME INFECTED RESULTING IN SCARRING AND DISFIGUREMENT. ADD'L MEDICAL INTERVENTION OR TREATMENT WAS NOT IDENTIFIED.
H7-THIS PRODUCT ALLEGED TO HAVE BEEN PART OF A PRODUCT RECALL IN 1994 WHICH HAS BEEN REPORTED IN PRODUCT LIABILITY LITIGATION RECEIVED ON 10/09/96.
REPORTER STATED, REVISION SURGERY REVEALED LOOSENING OF THE ACETABULAR SHELL. THE SUPERIOR PORTION OF THE ACETABULAR INSERT ROTATED INFERIORLY INSIDE THE SHELL ALLOWING DISLOCATION. BOTH COMPONENTS WERE REMOVED.
SUMMARY OF EVALUATION: THE COMPONENT CAN NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED TO CO. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN UNSUCCESSFUL. THE DEVICE HISTORY RECORDS FOR THE COMPONENTS WERE REVIEWED AND NO DISCREPANCIES WERE OBSERVED.
THE ORIGINAL MALFUNCTION REPORT WAS RECEIVED ON 10/1/96. INFO RELATING A SERIOUS INJURY WAS RECEIVED ON 11/1/96. ONE SYRINGE WAS RETURNED FOR EVALUATION. THE COMPONENTS MET SPECS AND PASSED ANSI GAGE TESTING. THERE HAVE BEEN NO SIMILAR REPORTS FROM OTHER FACILITIES CONCERNING THIS LOT.
PREVIOUSLY SURGERY CLINIC HAD REPORTED THIS EVENT (AND 2 OTHERS) AS A MALFUNCTION WITH NO PT INJURY. NOW SURGEON REPORTS THAT WHILE THE VISCOELASTIC WAS BEING INSTILLED IN THE EYE THROUGH THE PARACENTESIS, THE CANNULA BECAME DISLODGED FROM THE SYRINGE AND WAS FORCED ACROSS THE ANTERIOR CHAMBER, BOUNCING OFF THE ANTERIOR CAPSULE AND RESTING IN THE CILIARY SULCUS. NO OBSERVABLE RENT WAS NOTED IN THE ANTERIOR CAPSULE OR ZONULAR BREAKAGE NOTED AT THE TIME OF THE INCIDENT. AT 1 DAY POST-OPERATIVE RETINAL/CHOROIDAL DETACHMENT WAS DIAGNOSED AND THE PT WAS REFERRED TO A RETINAL SPECIALIST. A RETINAL LASER PROCEDURE WAS PERFORMED. PT IS REPORTED TO BE IMPROVING.
REVISION SURGERY REVEALED LOOSENING OF THE TIBIAL BASEPLATE.
CORRECTED DATA: H4: MANUFACTURE DATE: 3/23/94. SUMMARY OF EVALUATION: THE TIBIAL BASEPLATE CAN NOT BE EVALUATED FOR THE REPORTED LOSS OF FIXATION AS IT HAS BEEN RETURNED TO CO BUT RATHER HAS BEEN RETAINED BY THE PT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS BASEPLACE FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. SUMMARY OF EVALUATION: A VISUAL INSPECTION OF THE RETURNED TRIAL HEAD VERIFIED THE COMPLAINT. A DIMENSIONAL INSPECTION OF THE TRIAL HEAD VERIFIED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE EVALUATION INDICATES THAT THE POTENTIAL FOR CHIPPING OR FRACTURING OF THE PLASTIC EXISTS WHEN EXCESSIVE FORCE IS USED TO SEAT OR REMOVE THE TRIAL HEAD FROM THE STEM.
PT HAD EXCHANGE OF IMPLANT OF RIGHT SIDE. PT REQUIRED OPEN CAPSULECTOMY DUE TO RIGHT CAPSULAR CONTRACTURE. HER COMPLAINTS WERE PROGRESSIVE TIGHTNESS, PAIN, AND ABNORMAL SHAPE. THE CONTRACTURE WAS A GRADE 2 1/2 TO 3 PER MD NOTE. THE EXPLANT APPEARED INTACT PER MD NOTE.
REPORT RECEIVED OF LEAD EXTRACTION AND REPLACEMENT. PT DIED POST OPERATIVE.
THE PT, A IDDM, WAS REPORTEDLY VERY TIRED, "SHE WAS COMATOSE" ON 10/3, WITH SYMPTOMS OF NAUSEA, VOMITING AND HEADACHE. SHE HAD BEEN OBTAINING BLOOD GLUCOSE RESULTS ON HER METER IN THE 60'S FOR SEVERAL DAYS PRIOR TO 10/3. BASED UPON THESE LOW RESULTS, HER INSULIN WAS WITHHELD. THE PT WAS TRANSPORTED TO THE HOSP WHERE A BLOOD GLUCOSE RESULT OF "OVER 600" WAS OBTAINED (METHOD UNKNOWN). SHE WAS TREATED WITH INSULIN AND IV'S IN THE ER ADMITTED FOR HYPERGLYCEMIA AND RELEASED ON 10/6. CALIBRATION STATUS IS UNKNOWN AT THIS TIME, QUALITY CONTROL TESTS ARE NOT PERFORMED ON THE METER.
CO HAS COMPLETED ITS INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNK ANOMALY. AT THIS POINT INVESTIGATION OF THIS MATTER IS CLOSED.
A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PT'S CICRUMFLEX ARTERY. A DISSECTION OF THE CIRCUMFLEX ARTERY OCCURRED FOLLOWING POST-DILATION. ATTEMPTS TO ADVANCE A SECOND CORONARY STENT TO THE SITE OF DISSECTION WERE UNSUCCESSFUL. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION. THREE ADD'L STENTS (ANOTHER MANUFACTURER'S) WERE DEPLOYED IN AN ATTEMPT TO REESTABLISH CORONARY PERFUSION. THE CIRCUMFLEX ARTERY COLLAPSED. A DECISION WAS MADE TO OBSERVE THE PT RATHER THAN TO PERFORM A SURGICAL PROCEDURE. THERE WAS NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
PT'S DAUGHTER-IN-LAW REPORTED THAT THE PT , A TYPE II DIABETIC ON ORAL MEDICATION, OBTAINED LOWER BLOOD GLUCOSE READINGS WITH THE DEVICE. SOME TIME WITHIN THE LAST MONTH, THE PT OPENED THE FIRST BOTTLE OF TEST STRIPS WHICH PERFORMED ACCURATELY (150MG/DL RANGE). ON 10/7/96, PT WENT TO HER PHYSICIAN FOR A ROUTINE CHECK-UP AND PERFORMED A SIDE BY SIDE BLOOD GLUCOSE COMPARISON WITH TEST STRIPS AND HER PHYSICIAN'S TEST STRIPS (LOT UNK). BOTH TESTS WERE PERFORMED USING THE PT'S METER. BECAUSE SHE HAD JUST USED THE LAST TEST STRIP FROM THE BOTTLE OF 25, SHE OPENED THE SECOND BOTTLE OF TEST STRIPS FROM THE SAME BOX. SHE OBTAINED A BLOOD GLUCOSE RESULT OF 146 MG/DL WITH TEST STRIPS AND A RESULT OF 126 MG/DL WITH ANOTHER TEST STRIP. THE CONTACT STATED THAT DESICCANT WAS PRESENT IN THE FIRST BOTTLE OF TEST STRIPS. HOWEVER, WHEN THE PT OPENED THE SECOND BOTTLE AT HER PHYSICIAN'S OFFICE, THERE WAS NO DESICCANT PRESENT. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. WITH THE REP, THE PT OBTAINED A CHECK STRIP TEST RESULT OF 88 VERSUS A CHECK STRIP RANGE OF 75-101. PT DID NOT HAVE NORMAL CONTROL SOLUTION. PT STORES THE TEST STRIPS IN HER BEDROOM.
THE RETENTION SAMPLE TEST RESULTS FOR LOT 16057A MEET THE SPECS FOR THE BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. ERROR GRID ANALYSIS WAS PERFORMED USING CUSTOMER REPORTED SIDE BY SIDE COMPARISION RESULT WITH TEST STRIPS. ERROR GRID ANALYSIS INDICATES THAT CUSTOMER'S TEST STRIPS MAY PRODUCE RESULTS WHICH FALL IN ZONE A, AND DO NOT REPRESENT A REASONABLE RISK OF SERIOUS INJURY. CUSTOMER DID NOT RUN COMPARISON WITH AN ACCEPTABLE REFERENCE METHOD. PRODUCT SHOULD NOT BE COMPARED TO OTHER TEST STRIPS WHICH THEMSELVES MAY BE INACCURATE. CUSTOMER DID NOT PERFORM NORMAL CONTROL SOLUTION TEST TO CHECK THE STRIPS FOR ACCURACY. IN REVIEW OF THE DEVICE HSITORY RECORD FOR LOT 16057A, IT WAS CONCLUDED THAT THE REPORT OF MISSING DESICCANT IS AN ANOMALY AND IT IS UNLIKELY TO RECUR.  IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
ELEVEN IMPLANTS WERE PLACED, 4 OF WHICH WERE INVOLVED IN A SINUS LIFT. ONE IMPLANT IN THE SINUS LIFT AREA FAILED. THE DR THINKS THAT THIS FAILURE MAY HAVE BEEN CAUSED BY HAVING IT IN FUNCTION BY THE PT WEARING A FULL DENTURE (THE DENTURE HAVING PUT PRESSURE ON THE HEALING ABUTMENT FOR 5 MONTHS). ONE PERSON AFFECTED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. INFO RECEIVED FROM THE DR INDICATED THAT A FULL DENTURE WAS PUTTING PRESSURE ON THE HEALING ABUTMENT. THIS EARLY LOADING IS THE PROBABLE CAUSE OF FAILURE.
DISTRIBUTOR RECEIVED INFO THAT A PT WITH AN IMPLANTABLE CARDIOVERTER (ICD) AND LEAD SYSTEM EXPERIENCED OVERSENSING AND INAPPROPRIATE THERAPY. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO REMOVE FROM SERVICE (CAPPED) THE TWO UNIPOLAR RATE SENSING LEADS. A NEW BIPOLAR RATE SENSING LEAD WAS IMPLANTED. THIS PROCEDURE WAS PERFORMED ON 8/9/94. A RECENT CO DISTRIBUTOR INTERNAL DEPARTMENT REVIEW IDENTIFIED PAPERWORK FROM THE 8/9/94 PROCEDURE. ON 10/25/96 DISTRIBUTOR LEARNED THAT THIS PT'S COMPLETE (ICD) SYSTEM WAS REMOVED 8/26/96 DUE TO INFECTION.
THE LEAD HAS BEEN CAPPED AND REMAIN IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVAL. CO IS UNABLE TO DRAW CONCLUSIONS FROM THE AVIAILABLE INFO ON INAPPROPIATE SHOCKS. NO FURTHER INFO IS AVAILABLE.
IT WAS REPORTED IN THE JOURNAL OF ANESTHESIA AND INTENSIVE CARE MEDICINE, VOL. 24, NO. 3, JUNE 1996, THAT A 31 Y/O MALE SUFFERING BURNS RECEIVED 10 LITRES OF FLUID WITH A MALPOSITIONED SHEATH INTRODUCER PLACED IN THE FEMORAL VEIN. THE CAUSE OF THIS INCIDENT IS PHYSICIAN ERROR. REFER TO THE ATTACHED ARTICLE FOR ADD'L INFO.
DISTRIBUTOR RECEIVED INFO THAT A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD SYSTEM EXPEREINCED OVERSENSING AND INAPPROPRIATE THERAPY. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO REMOVE FROM SERVICE (CAPPED) THE TWO UNIPOLAR RATE SENSING LEADS. A NEW BIPOLAR SENSING LEAD WAS IMPLANTED. THIS PROCEDURE WAS PERFORMED 8/9/94. A RECENT DISTRIBUTOR INTERNAL DEPT REVIEW IDENTIFIED PAPERWORK FROM THE 8/9/94 PROCEDURE. ON 10/25/96 DISTRIBUTOR LEARNED THAT THIS PT'S COMPLETE (ICD) SYSTEM WAS REMOVED 8/26/96 DUE TO INFECTION.
THE PORT WAS PLACED IN THE PT ON 7/31/96 FOR CONTINUOUS INFUSIONS OF HEPARIN. NO PROBLEMS WERE ENCOUNTERED WITH THE PORT WHILE IT WAS IN USE. DURING REMOVAL OF THE PORT ON 6/17/96, IT WAS DISCOVERED THAT PART OF THE CATHETER HAD BROKEN OFF.
A X-RAY AND FLUOROSCOPY WERE DONE WHICH SHOWED A 3-5 CM CATHETER FRAGMENT IN THE PT'S PULMONARY ARTERY. THE CATHETER FRAGMENT WAS REMOVED AT THAT TIME. THE DEVICE WAS UNABLE TO BE EVAL AS ITS LOCATION IS PRESENTLY UNKNOWN.
QR AXLE W/NUT. DEALER CLAIMS THE AXLE IS MISSING THE BALL BEARINGS, AND THE WHOLE CTR SECTION CAME OUT.
THIS IS THE FIRST OF 9 REPORTS CONCERNING PTS TREATED IN THE OUTPATIENT RENAL DIALYSIS CTR, WHO HAVE BEEN IDENTIFIED AS HAVING ELEVATED LEAD LEVELS IN THEIR BLOOD. ALL SUBSEQUENT PT REPORTS WILL BE REFERENCED TO THIS PT IDENTIFIER OR AS NUMBER 1. THIS PT WAS HOSPITALIZED 10/11/96 WITH GENERALIZED SYSTEMIC CONDITIONS. DURING HOSPITALIZATION HE DEVELOPED PROGRESSIVE MUSCLE WEAKNESS NECESSITATING TRANSFER TO ICU. HE DID NOT REQUIRE VENTILATORY ASSISTANCE. BLOOD SAMPLING REVEALED ELEVATED SERUM LEAD LEVELS. HE CURRENTLY REMAINS HOSPITALIZED, BUT IS GRADUALLY IMPROVING. INVESTIGATION: AS SOON AS THE ELEVATED SERUM LEAD LEVELS WERE IDENTIFIED. THE DIALYSIS CTR SAMPLED THE H2O SUPPLY WHICH RATED AT <0.001MG/DL; WELL WITHIN THE ACCEPTABLE LIMIT. FURTHER INVESTIGATIVE EFFORTS IDENTIFIED ONE PARTICULAR ACID BATH AS THE MOST LIKELY SOURCE OF CONTAMINATION, AND IT WAS IMMEDIATELY TAKEN OUT OF SVC. ALL REMAINING DIALYSATE BATHS HAVE BEEN SAMPLED ON SEVERAL OCCASIONS AND TESTED CONSISTENTLY WITHIN ACCEPTABLE LIMITS. NUMEROUS INTERNAL AND EXTERNAL EXPERTS HAVE BEEN CONSULTED, AND EFFORTS ARE ONGOING TO CONCLUSIVELY PINPOINT THE SOURCE OF THE LEAD CONTAMINATION. A SIGNIFICANT NUMBER OF PTS OF THE REMAINING PTS ON THE REMAINING BATHS WERE ALSO RANDOMLY SAMPLED. ONE OF THEM HAD BEEN ON THE BATH IN QUESTION FOR A TWO WEEK PERIOD, AND HAD AN ELEVATED LEVEL. THE REMAINING PTS TESTED WITHIN ACCEPTABLE LEVELS. ONE PT WHO HAD BEEN ON THE BATH IN QUESTION EXPIRED BEFORE THE ELEVATED SERUM LEVELS HAD BEEN DETECTED, SO HIS SERUM LEVELS ARE UNKNOWN. IN REVIEWING HIS RECORDS, HOWEVER, HIS PHYSICIANS DO NOT BELIEVE HIS EXPIRATION WAS IN ANYWAY RELATED TO LEAD CONTAMINATION. ONE ADD'L PT WHO HAD BEEN ON THE BATH IN QUESTION HAD RECEIVED INPATIENT DIALYSIS DURING HOSPITALIZATION FOR TREATMENT OF A PERFORATED ULCER, AND WHEN SAMPLED FOR SERUM LEAD, TESTED L5 MG/DL.
RENAL DIALYSIS PT HOSPITALIZED 9/27 - 10/2/96 WITH NEW SEIZURE DISORDER; LOW BACK AND ABDOMINAL PAINS. 10/18/96 SEVERE ABDOMINAL PAIN WITH TENDERNESS. DIALYSATE WITH IMPROVEMENT OF SYMPTOMS. HOSPITALIZATION FOR FURTHER POTASSIUM CHLORIDE SUPPLEMENTATION. DEVELOPED PROGRESSIVE FATIGUE, WEAKNESS, AND DYSPNEA. TRANSFERRED TO INTENSIVE CARE. LEAD LEVEL ELEVATED. REMAINS HOSPITALIZED AS OF 10/30/96. PT ON BATH DIALYSATE. WATER AT FACILITY CHECKED <0.001 LEAD LEVEL. THIS IS THE SECOND OF 9 REPORTS. ALL REMAINING DIALYSATE BATHS HAVE BEEN SAMPLED ON SEVERAL OCCASIONS AND TESTED CONSISTENTLY WITHIN ACCEPTABLE LIMITS. NUMEROUS INTERNAL AND EXTERNAL EXPERTS HAVE BEEN CONSULTED, AND EFFORTS ARE ONGOING TO CONCLUSIVELY PINPOINT THE SOURCE OF THE LEAD CONTAMINATION. A SIGNIFICANT NUMBER OF PTS ON THE REMAINING BATHS WERE ALSO RANDOMLY SAMPLED. ONE OF THEM HAD BEEN ON THE BATH IN QUESTION FOR A TWO WEEK PERIOD, AND HAD AN ELEVATED LEVEL. THE REMAINING PTS TESTED WITHIN ACCEPTABLE LEVELS. ONE PT WHO HAD BEEN ON THE BATH IN QUESTION EXPIRED BEFORE THE ELEVATED SERUM LEVELS HAD BEEN DETECTED, SO HIS SERUM LEVELS ARE UNKNOWN. IN REVIEWING HIS RECORDS, HOWEVER, HIS PHYSICIANS DO NOT BELIEVE HIS EXPIRATION WAS IN ANY WAY RELATED TO LEAD CONTAMINATION. ONE ADD'L PT WHO HAD BEEN ON THE BATH IN QUESTION HAD RECEIVED INPATIENT DIALYSIS DURING HOSPITALIZATION FOR TREATMENT OF A PERFORATED ULCER, AND WHEN SAMPLED FOR SERUM LEAD, TESTED L5 MG/DL.
#3 OF 9. RENAL DIALYSIS PT WAS HOSPITALIZED 2-3 DAYS IN 5/95 FOR ABDOMINAL PAIN WITH HISTORY DIAGNOSIS OF DIVERTICULOSIS AND MILD DIVERTICULITIS. COMPLAINTS CONTINUED AT INTERMITTENT INTERVALS. PT ALSO HAS HYPERPARATHYROIDISM. (PT H> 1000). HOSP 10/9/96 ABD PAIN AND OTHER GI SYMPTOMS AND HYPOKALEMIA, DIALYSATE CHANGED. WAS ON BATH FOR DIALYSIS. FACILITY <0.001 10/16/96 CHECKED FOR LEAD LEVELS ELEVATED IN BLOOD. DISCHARGED FROM HOSP. ALL REMAINING DIALYSATE BATHS HAVE BEEN SAMPLED ON SEVERAL OCCASIONS AND TESTED CONSISTENTLY WITHIN ACCEPTABLE LIMITS. NUMEROUS INTERNAL AND EXTERNAL EXPERTS HAVE BEEN CONSULTED, AND EFFORTS ARE ONGOING TO CONCLUSIVELY PINPOINT THE SOURCE OF THE LEAD CONTAMINATION. A SIGNIFICANT NUMBER OF PTS OF THE REMAINING PTS ON THE REMAINING BATHS WERE ALSO RANDOMLY SAMPLED. ONE OF THEM HAD BEEN ON THE BATH IN QUESTION FOR A TWO WEEK PERIOD, AND HAD AN ELEVATED LEVEL. THE REMAINING PTS TESTED WITHIN ACCEPTABLE LEVELS. ONE PT WHO HAD BEEN ON THE BATH IN QUESTION EXPIRED BEFORE THE ELEVATED SERUM LEVELS HAD BEEN DETECTED, SO HIS SERUM LEVELS ARE UNKNOWN. IN REVIEWING HIS RECORDS, HOWEVER, HIS PHYSICIANS DO NOT BELIEVE HIS EXPIRATION WAS IN ANY WAY RELATED TO LEAD CONTAMINATION. ONE ADD'L PT WHO HAD BEEN ON THE BATH IN QUESTION HAD RECEIVED INPATIENT DIALYSIS DURING HOSPITALIZATION FOR TREATMENT OF A PERFORATED ULCER, AND WHEN SAMPLED FOR SERUM LEAD, TESTED L5 MG/DL.
THIS IS THE FOURTH RENAL DIALYSIS PT. INTERMITTENTLY COMPLAINED OF OR WAS HOSPITALIZED FOR ABDOMINAL PAIN BEGINNING 8/96. (ER VISITS AND HOSPITALIZED 9/4/96; 9/7/96; 9/9/96) 10/3/96. CHECKED FOR GI & GU PROBLEMS AND BOTH OF WHICH WERE NEGATIVE, ALSO HAD PSYCHIATRIC EVAL AND TREATMENT BEGAN. LOW BACK PAIN AND WEAKNESS IN LOWER BACK AND THIGHS BEGAN MID OCT 1996. HOSPITALIZED 10/18/96 DUE TO PROGRESSIVE WEAKNESS; INABILITY TO AMBULATE, NAUSEA/VOMITING AND VOLUME DEPLETION. ON 10/16/96 CHECKED FOR LEAD LEVEL (ELEVATED). REMAINS HOSPITALIZED AS OF 10/30/96. PT ON BATH. WATER CHECKED AT FACILITY <10001. ALL REMAINING DIALYSATE BATHS HAVE BEEN SAMPLED ON SEVERAL OCCASIONS AND TESTED CONSISTENTLY WITHIN ACCEPTABLE LIMITS. NUMEROUS INTERNAL AND EXTERNAL EXPERTS HAVE BEEN CONSULTED, AND EFFORTS ARE ONGOING TO CONCLUSIVELY PINPOINT THE SOURCE OF THE LEAD CONTAMINATION. A SIGNIFICANT NUMBER OF PTS OF THE REMAINING PTS ON THE REMAINING BATHS WERE ALSO RANDOMLY SAMPLED. ONE OF THEM HAD BEEN ON THE BATH IN QUESTION FOR A TWO WEEK PERIOD, AND HAD AN ELEVATED LEVEL. THE REMAINING PTS TESTED WITHIN ACCEPTABLE LEVELS. ONE PT WHO HAD BEEN ON THE BATH IN QUESTION EXPIRED BEFORE THE ELEVATED SERUM LEVELS HAD BEEN DETECTED, SO HIS SERUM LEVELS ARE UNKNOWN. IN REVIEWING HIS RECORDS, HOWEVER, HIS PHYSICIANS DO NOT BELIEVE HIS EXPIRATION WAS IN ANY WAY RELATED TO LEAD CONTAMINATION. ONE ADD'L PT WHO HAD BEEN ON THE BATH IN QUESTION HAD RECEIVED INPATIENT DIALYSIS DURING HOSPITALIZATION FOR TREATMENT OF A PERFORATED ULCER, AND WHEN SAMPLED FOR SERUM LEAD, TESTED L5 MG/DL.
THIS IS THE FIFTH RENAL DIALYSIS PT BEGAN DEVELOPING MUSCLE WEAKNESS, FATIGUE, APTHRALGIA, N/V, ANOREXIA AND ABDOMINAL PAIN IN SEPT OF 1996. PROGRESSIVE WEAKNESS AND ABDOMINAL PAIN. PLACED ON HIGH DOSES OF PREDNISONE AND AGAIN BEGAN HAVING PROGRESSIVE IMPROVEMENT IN SYMPTOMS. DISCHARGED FROM HOSP. THERE ARE A TOTAL OF 9 PTS ON BATH WITH ELEVATED LEAD LEVELS. NOTED MID OCT 1996. PT PLACED ON DIALYSATE BATH 9/11/96. OCCUPATION PRECLUDES EXPOSURE TO HEAVY CHEMICALS. TESTED FOR LEAD LEVELS IN 10/96. ETIOLOGY OF LEAD EXPOSURE AT THIS TIME UNKNOWN. WATER TESTED AT DIALYSIS CENTER <O.001. ALL REMAINING DIALYSATE BATHS HAVE BEEN SAMPLED ON SEVERAL OCCASIONS AND TESTED CONSISTENTLY WITHIN ACCEPTABLE LIMITS. NUMEROUS INTERNAL AND EXTERNAL EXPERTS HAVE BEEN CONSULTED, AND EFFORTS ARE ONGOING TO CONCLUSIVELY PINPOINT THE SOURCE OF THE LEAD CONTAMINATION. A SIGNIFICANT NUMBER OF PTS OF THE REMAINING PTS ON THE REMAINING BATHS WERE ALSO RANDOMLY SAMPLED. ONE OF THEM HAD BEEN ON THE BATH IN QUESTION FOR A TWO WEEK PERIOD, AND HAD AN ELEVATED LEVEL. THE REMAINING PTS TESTED WITHIN ACCEPTABLE LEVELS. ONE PT WHO HAD BEEN ON THE BATH IN QUESTION EXPIRED BEFORE THE ELEVATED SERUM LEVELS HAD BEEN DETECTED, SO HIS SERUM LEVELS ARE UNKNOWN. IN REVIEWING HIS RECORDS, HOWEVER, HIS PHYSICIANS DO NOT BELIEVE HIS EXPIRATION WAS IN ANY WAY RELATED TO LEAD CONTAMINATION. ONE ADD'L PT WHO HAD BEEN ON THE BATH IN QUESTION HAD RECEIVED INPATIENT DIALYSIS DURING HOSPITALIZATION FOR TREATMENT OF A PERFORATED ULCER, AND WHEN SAMPLED FOR SERUM LEAD, TESTED L5 MG/DL.
RENAL DIALYSIS PT ON BATH. CHECKED FOR LEAD LEVELS. WATER AT DIALYSIS CENTER LEAD LEVEL <0.001. ALL REMAINING DIALYSATE BATHS HAVE BEEN SAMPLED ON SEVERAL OCCASIONS AND TESTED CONSISTENTLY WITHIN ACCEPTABLE LIMITS. NUMEROUS INTERNAL AND EXTERNAL EXPERTS HAVE BEEN CONSULTED, AND EFFORTS ARE ONGOING TO CONCLUSIVELY PINPOINT THE SOURCE OF THE LEAD CONTAMINATION. A SIGNIFICANT NUMBER OF PTS ON THE REMAINING BATHS WERE ALSO RANDOMLY SAMPLED. ONE OF THEM HAD BEEN ON THE BATH IN QUESTION FOR A TWO WEEK PERIOD. AND HAD AN ELEVATED LEVEL. THE REMAINING PTS TESTED WITHIN ACCEPTABLE LEVELS. ONE PT WHO HAD BEEN ON THE BATH IN QUESTION EXPIRED BEFORE THE ELEVATED SERUM LEVELS HAD BEEN DETECTED, SO HIS SERUM LEVELS ARE UNKNOWN. IN REVIEWING HIS RECORDS, HOWEVER, HIS PHYSICIANS DO NOT BELIEVE HIS EXPIRATION WAS IN ANY WAY RELATED TO LEAD CONTAMINATION. ONE ADD'L PT WHO HAD BEEN ON THE BATH IN QUESTION HAD RECEIVED INPATIENT DIALYSIS DURING HOSPITALIZATION FOR TREATMENT OF A PERFORATED ULCER, AND WHEN SAMPLED FOR SERUM LEAD, TESTED L5 MG/DL.
RENAL DIALYSIS PT ON BATH. PT IS ASYMPTOMATIC BUT LEAD LEVELS CHECKED ON ALL PTS ON THIS DIALYSATE MIXTURE. WATER AT DIALYSIS CTR <0.001. ALL REMAINING DIALYSATE BATHS HAVE BEEN SAMPLED ON SEVERAL OCCASIONS AND TESTED CONSISTENTLY WITHIN ACCEPTABLE LIMITS. NUMEROUS INTERNAL AND EXTERNAL EXPERTS HAVE BEEN CONSULTED, AND EFFORTS ARE ONGOING TO CONCLUSIVELY PINPOINT THE SOURCE OF THE LEAD CONTAMINATION. A SIGNIFICANT NUMBER OF PTS OF THE REMAINING PTS ON THE REMAINING BATHS WERE ALSO RANDOMLY SAMPLED. ONE OF THEM HAD BEEN ON THE BATH IN QUESTION FOR A TWO WEEK PERIOD, AND HAD AN ELEVATED LEVEL. THE REMAINING PTS TESTED WITHIN ACCEPTABLE LEVELS. ONE PT WHO HAD BEEN ON THE BATH IN QUESTION EXPIRED BEFORE THE ELEVATED SERUM LEVELS HAD BEEN DETECTED, SO HIS SERUM LEVELS ARE UNKNOWN. IN REVIEWING HIS RECORDS, HOWEVER, HIS PHYSICIANS DO NOT BELIEVE HIS EXPIRATION WAS IN ANY WAY RELATED TO LEAD CONTAMINATION. ONE ADD'L PT WHO HAD BEEN ON THE BATH IN QUESTION HAD RECEIVED INPATIENT DIALYSIS DURING HOSPITALIZATION FOR TREATMENT OF A PERFORATED ULCER, AND WHEN SAMPLED FOR SERUM LEAD, TESTED L5 MG/DL.
PT IS ASYMPTOMATIC BUT LEAD LEVELS CHECKED ON ALL PTS ON THIS DIALYSATE MIXTURE. WATER AT FACILITY <0.001. ALL REMAINING DIALYSATE BATHS HAVE BEEN SAMPLED ON SEVERAL OCCASIONS AND TESTED CONSISTENTLY WITHIN ACCEPTABLE LIMITS. NUMEROUS INTERNAL AND EXTERNAL EXPERTS HAVE BEEN CONSULTED, AND EFFORTS ARE ONGOING TO CONCLUSIVELY PINPOINT THE SOURCE OF THE LEAD CONTAMINATION. A SIGNIFICANT NUMBER OF PTS OF THE REMAINING PTS ON THE REMAINING BATHS WERE ALSO RANDOMLY SAMPLED. ONE OF THEM HAD BEEN ON THE BATH IN QUESTION FOR A TWO WEEK PERIOD, AND HAD AN ELEVATED LEVEL. THE REMAINING PTS TESTED WITHIN ACCEPTABLE LEVELS. ONE PT WHO HAD BEEN ON THE BATH IN QUESTION EXPIRED BEFORE THE ELEVATED SERUM LEVELS HAD BEEN DETECTED, SO HIS SERUM LEVELS ARE UNKNOWN. IN REVIEWING HIS RECORDS, HOWEVER, HIS PHYSICIANS DO NOT BELIEVE HIS EXPIRATION WAS IN ANY WAY RELATED TO LEAD CONTAMINATION. ONE ADD'L PT WHO HAD BEEN ON THE BATH IN QUESTION HAD RECEIVED INPATIENT DIALYSIS DURING HOSPITALIZATION FOR TREATMENT OF A PERFORATED ULCER, AND WHEN SAMPLED FOR SERUM LEAD, TESTED L5 MG/DL.
THIS IS THE LAST PT #9. PT IS ASYMPTOMATIC, TESTS FOR LEAD LEVELS PERFORMED ON ALL PTS RECEIVING BATH DIALYSATE. WATER AT FACILITY CENTER <0.001. ALL REMAINING DIALYSATE BATHS HAVE BEEN SAMPLED ON SEVERAL OCCASIONS AND TESTED CONSISTENTLY WITHIN ACCEPTABLE LIMITS. NUMEROUS INTERNAL AND EXTERNAL EXPERTS HAVE BEEN CONSULTED, AND EFFORTS ARE ONGOING TO CONCLUSIVELY PINPOINT THE SOURCE OF THE LEAD CONTAMINATION. A SIGNIFICANT NUMBER OF PTS OF THE REMAINING PTS ON THE REMAINING BATHS WERE ALSO RANDOMLY SAMPLED. ONE OF THEM HAD BEEN ON THE BATH IN QUESTION FOR A TWO WEEK PERIOD, AND HAD AN ELEVATED LEVEL. THE REMAINING PTS TESTED WITHIN ACCEPTABLE LEVELS. ONE PT WHO HAD BEEN ON THE BATH IN QUESTION EXPIRED BEFORE THE ELEVATED SERUM LEVELS HAD BEEN DETECTED, SO HIS SERUM LEVELS ARE UNKNOWN. IN REVIEWING HIS RECORDS, HOWEVER, HIS PHYSICIANS DO NOT BELIEVE HIS EXPIRATION WAS IN ANY WAS RELATED TO LEAD CONTAMINATION. ONE ADD'L PT WHO HAD BEEN ON THE BATH IN QUESTION HAD RECEIVED INPATIENT DIALYSIS DURING HOSPITALIZATION FOR TREATMENT OF A PERFORATED ULCER, AND WHEN SAMPLED FOR SERUM LEAD, TESTED L5 MG/DL.
THE DEVICE WAS IMPLANTED ON 7/26/95 FOR INFUSION OF MORPHINE FOR TREATMENT OF PAIN. ON 10/9/96, THE FACILITY NURSE CONTACTED A MFR NURSE AND STATED THAT SHE HAS NOTED A SLOWLY DECREASING DEVICE FLOW RATE. THE FACILITY NURSE PERFORMED THE DEVICE AIR LOCK PROCEDURE ON 10/8/96 AND GOT BACK SOME AIR. THE PT WAS SCHEDULED TO RETURN TO THE OFFICE ON 10/14/96 FOR REEVALUATION. IN 1995 THE DEVICE FLOW RATES WERE 1.5 ML/DAY, 1.4 ML/DAY, AND 1.3MDL/DAY. IN MARCH, 1996 THE DEVICE FLOW RATE WAS 1.2ML/DAY. THE PT THEN WENT TO OTHER STATE FOR SEVERAL MONTHS AND A DECREASED FLOW RATE WAS NOTED UPON HER RETURN. THE FACILITY NURSE THEN REPORTED THE FOLLOWING DEVICE REFILL DATA: 6/18/96-FLOW RATE(FR)-.96ML/DAY; 7/15/96-FR=.83ML/DAY-8/12/96-.82ML/DAY; 9/9/96-FR=.75ML/DAY; 10/8/96-FR=.76ML/DAY. THE FACILITY NURSE STATED THAT IF THE DEVICE FLOW RATE IS NOT INCREASED BY 10/14/96, THEN A DEVICE SIDEPORT STUDY WILL BE PERFORMED TO DETERMINE IF THE DEVICE CATHETER MAY BE KINKED. THE FACILITY USES THE MFR'S DEVICE REFILL KITS.
ON 12/3/96, THE MFR CONTACTED THE FACILITY NURSE TO OBTAIN FOLLOW UP INFORMATION CONCERNING THIS PATIENT/DEVICE. THE FACILITY NURSE STATED THAT THE PHYSICIAN HAD AGAIN INCREASED THE DRUG DOSAGE (DOSAGE AMOUNT WAS NOT AVAILABLE); HOWEVER, THE PATIENT IS STILL NOT EXPERIENCING ADEQUATE PAIN RELIEF. IN ADDITION, THE FACILITY NURSE STATED THAT THE DEVICE IS STILL FLOWING LESS THEN THE PREDICATED RATE. THE PHYSICIAN IS CONTINUING TO WORK WITH THE DEVICE AT THE CURRENT FLOW RATE AND DOES NOT PLAN TO EXPLANT THE DEVICE AT THIS TIME. THE FACILITY NURSE WAS INFORMED THAT THE MFR WOULD FOLLOW UP WITH HER AGAIN IN SEVERAL WEEKS AND IF AT THAT TIME, THE PHYSICIAN STILL DID NOT HAVE ANY PLANS TO EXPLANT THE DEVICE, THEN THE FILE WOULD BE CLOSED; HOWEVER, IF AT A LATER DATE THE DECISION WAS MADE TO EXPLANT THE DEVICE, THEN THE MFR WOULD REOPEN ITS INVESTIGATION AT THAT TIME. ON 12/30/96, THE FACILITY NURSE REPORTED THAT THE PATIENT'S PAIN IS MUCH BETTER AND THE PATIENT HAS BEEN RESTARTED ON CHEMOTHERAPY (THE DEVICE WAS IMPLANTED FOR INFUSION OF MORPHINE; HOWEVER, CHEMOTHERAPY HAD BEEN TEMPORARILY SUSPENDED.) THE FACILITY NURSE ALSO STATED THAT SHE BELIEVES THAT THE DEVICE FLOW RATE HAS STABILIZED; HOWEVER, SHE DID NOT HAVE THE EXACT REFILL DATA AVAILABLE. THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN. SINCE THE DEVICE WILL REMAIN IMPLANTED, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PART/SERIAL NUMBER. A TREND ANALYSIS WAS PERFORMED ON THIS PART/SERIAL NUMBER AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. BASED ON THE AVAILABLE INFORMATION AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. ALTHOUGH NO PART OF THE MFR'S ORIGINAL OCTOBER, 1992 DEVICE SAFETY ALERT, INSTRUCTIONS PROVIDED IN THE ALERT GUIDELINES APPLY TO THIS DEVICE. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
CUSTOMER IS A FIRST TIME USER OF TEST STRIPS WHO REPORTED LOW READINGS. CUSTOMER IS PREGNANT AND IS IN DAILY CONTACT WITH HER PHYSICIAN (OBGYN). WHEN SHE REPORTED OBTAINING (AT DIFFERENT TIME) READINGS OF 82, 75, AND 63 MG/DL TO HER DR., SHE ADVISED HER TO DISCONTINUE USING TEST STRIPS AND TO USE ANOTHER BRAND OF TEST STRIPS. THE CUSTOMER DID NOT HAVE NORMAL CONTROL SOLUTION SO A CONTROL SOLUTION TEST COULD NOT BE PERFORMED WITH THE REP. WITH THE REP THE CUSTOMER PERFORMED A CHECK STRIP TEST. THE RESULT WAS 87 VERSUS A CHECK STRIP RANGE OF 72-98. THE DESICCANT IS IN THE OPEN BOTTLE. THE CUSTOMERR STORES HER TEST STRIPS IN HER BEDROOM.
CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 10/30/96. TWO BOTTLES WITH DESICCANT, ONE OPENED CONTAINING 16 STRIPS AND ONE UNOPENED CONTAINING 25 STRIPS, WERE RETURNED TO CO FOR EVAL. THE TEST RESULT OF BOTH RETURNED BOTTLES FELL BELOW THE SPEC FOR BLOOD GLUCOSE ACCURACY. ERROR GRID ANALYSIS BASED ON THE TEST RESULTS OBTAINED BY CO INDICATES THAT : 1) THE RETURNED TEST STRIPS FROM THE CUSTOMER OPENED BOTTLE MAY HAVE PRODUCED RESULTS WHICH FALL IN ZONE A, B, AND D, AND REPRESENT A REASONABLE RISK OF SERIOUS INJURY; 2) THE RETURNED TEST STRIPS FROM THE UNOPENED BOTTLE MAY PRODUCE RESULTS WHICH FALL IN ZONE A AND B, AND DO NOT REPRESENT A REASONABLE RISK OF SERIOUS INJURY. EVAL OF THE DESICCANT INSIDE THE RETURNED BOTTLES INDICATES THAT FAILURE MAY NOT BE DUE TO EXPOSURE TO MOISTURE. THE RETENTION SAMPLE TEST RESULTS FOR LOT 1J515B MEET THE SPECS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE STRIPS PERFORMANCE FROM THE RETENTION MATERIAL, PRODUCT FAILURE IN THE FIELD IS UNLIKELY TO BE OBSERVED. THERE ARE FACTORS OTHER THAN MOISTURE EXPOSURE MAY CAUSE PRODUCT FAILURE IN THE FIELD SUCH AS HEAT. THE CAUSE OF CUSTOMER REPORTED PRODUCT FAILURE IS UNK. BASED ON THE EVAL OF RETENTION SAMPLES, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MDR DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
ATTORNEY FOR A PT CLAIMS THAT SHE WAS BURNED AS A RESULT OF HOT WATER BEING POURED ON HER DURING A SURGICAL PROCEDURE. IT IS ALLEGED THE FLUID/SOLUTION HAS BEEN HEATED IN A WARMING CABINET.
A LETTER WAS RECEIVED ON 10/7/96 BY CUSTOMER SERVICE FROM ATTORNEY REQUESTING A "PROCEDURE MANUAL AND INSTRUCTION MANUAL FOR AN OPERATING ROOM WARMING CABINET". ATTY ALLEGES HE MADE AN EARLIER REQUEST FOR THIS MATERIAL ON 9/23/96. A SEARCH OF CO'S RECORDS REVEALED NO RECORD OF THIS EARLIER NOTIFICATION, AND AS FAR AS COULD BE DETERMINED HIS LETTER DATED 10/4/96 WAS ITS FIRST INDICATION OF HIS REQUEST OR THAT AN EVENT HAD OCCURRED. FURTHER IN THIS LETTER, IT IS ALLEGED THAT HIS CLIENT SUSTAINED BURNS "AS A RESULT OF HOT WATER BEING POURED ON HER DURING A SURGICAL PROCEDURE. THE WATER HAD BEEN HEATED IN YOUR CABINET." PURSUANT TO THIS REQUEST, FIELD SERVICE RESPONDED IN WRITING, THAT CO WOULD ATTEMPT TO COMPLY WITH THIS REQUEST, BUT ADD'L INFO WAS NEEDED. IT WAS REQUESTED THAT CO BE PROVIDED WITH INFO REGARDING THE TYPE OF WARMING CABINET INVOLVED, AND THE DATE OF MANUFACTURE, IN ORDER TO PROVIDE THE CORRECT LITERATURE. TO DATE (11/6/96), THERE HAS BEEN NO RESPONSE TO CO'S REQUEST FOR THIS INFO. WITHOUT THIS CO CANNOT PROPERLY EVALUATE THE EVENT. CO AT PRESENT DOES NOT KNOWN WHAT TYPE OF WARMING CABINET IN QUESTION WAS MANUFACTURED BY CO. IN ADDITION, CO HAS NO REASON TO BELIEVE THIS WARMING CABINET MALFUNCTIONED. THE PURPOSE OF WARMING CABINET IS TO WARM SOLUTIONS, AND IT IS THE RESPONSIBILITY OF HOSP PERSONNEL TO MEASURE THE TEMPERATURE OF SOLUTIONS BEFORE USING A HEATED SOLUTION ON LIVING TISSUE TO REDUCE/ELIMINATE A BURN HAZARD. WARMING CABINETS ARE LABELED TO THIS EFFECT, PRIOR TO SHIPMENT. THIS REPORT IS BEING SUBMITTED BECAUSE CO DOES NOT KNOW AT THIS TIME IF THE ALLEGATION THAT AN WARMING CABINET WAS INVOLVED IN THE EVENT IS FACTUAL. IF ADD'L INFO IS MADE AVAILABLE TO CO AT A LATER DATE, IT WILL BE FORWARDED TO FDA. UNLESS ADD'L PERTINENT INFO ARISES CO PLANS TO TAKE NO FURTHER ACTION AND CONSIDERS THIS CLOSED.
THE DEVICE WAS IMPLANTED ON 3/27/96, FOR INTRATHECAL INFUSION OF MORPHINE FOR TREATMENT OF PAIN. ON 10/10/96, THE FACILITY NURSE INFORMED A MFR CLINICAL REPRESENTATIVE THAT THIS PT HAS HAD GOOD PAIN CONTROL UNTIL TWO (2) MONTHS AGO (APPROX 8/96) WHEN THE PT STARTED TO COMPLAIN OF NO PAIN RELIEF. A DYE STUDY THROUGH THE DEVICE PORT (DATE NOT SPECIFIED) REVEALED THAT THE INTRATHECAL CATHETER WAS IN PLACE. THE CALIBRATED FLOW RATE OF THE DEVICE IS 1.1ML/DAY; HOWEVER, DURING THE LAST DEVICE REFILL THE RETURN VOLUME (RV)=27CC, THE REFILL PERIOD (RP)=DAYS AND THE FLOW RATE (FR)=0.56ML/DAY. THE MFR'S CLINICAL REPRESENTATIVE SUGGESTED THAT THE DEVICE AIR LOCK PROCEDURE BE PERFORMED.
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND HAS BEEN ANALYZED AS FOLLOWS: NORMAL USAGE WAS SEEN ON THE CENTER AND SEPTA WITH NO INTERNAL FRACTURE PLANE DAMAGE FOUND. THE DEVICE DID NOT LEAK WHILE PRESSURIZING THE DEVICE OR FILLING THE DEVICE RESERVOIR. THE DEVICE WAS PATENT UPON FLUSING AND NO RESISTANCE WAS FELT. APPROXIMATELY 5 MLS OF CLEAR, COLORLESS, PARTICLE FREE FLUID, WHICH TESTED NEGATIVE FOR BLOOD WAS COLLECTED. THE DEVICE FLOWED WITHIN ORIGINAL MANUFACTURER FLOW RATE SPECIFICATIONS AS RECEIVED. LEAK TESTING OF THE DEVICE CONFIRMED THAT THE DEVICE DID NOT LEAK. THE DEVICE PERFORMED AS INTENDED DURING THE MANUFACTURER'S ANALYSIS. VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE CATHETER CONFIRMED NO DEFECTS OR ANOMALIES. (NOTE: AN INTRATHECAL CATHETER WAS NOT RETURNED WITH THIS DEVICE. A TREND ANALYSIS WAS PERFOMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING VARIANCES RELATED TO THIS EVENT FOR THIS DEVICE. BASED ON THE INFORMATION AVAILABLE ANDN THE RESULTS OF THE MANUFACTURER'S ANALYSIS WHICH REVEALES THAT THE DEVICE PERFORMED AS INTENDED, THE COMPLAINT THAT "THE DEVICE WAS FLOWING SLOW/PT WAS NOT RECEIVING PAIN RELIEF" COULD NOT BE CORFIRMED;  THEREFORE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MANUFACTURER IS NOW CLOSING THE FILE ON THIS EVENT.THE DEVICE HAS BEEN RETURNED TO THE MFR AND IS PRESENTLY UNDERGOING ANALYSIS. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.
THE PORT WAS PLACED 5/29/96 FOR CHEMOTHERAPY. ON 9/20/96, IT WAS REPORTED THAT THERE WAS SOME RESISTANCE DURING FLUSHING AND THE INFUSION ONLY FLOWED IF THE PT'S ARM WAS RAISED. SWELLING WAS REPORTED DIRECTLY ABOVE THE PORT. THE PORT WAS DEACCESSED AND A FLUOROSCOPY WAS DONE.
A PORT WITH CATHETER WAS RETURNED FOR EVALUATION. THE CATHETER HAD BEEN SEVERED INTO TWO SEGMENTS. TACTUAL EXAMINATION OF THE CATHETER SEGMENTS FOUND THE TUBING AHD BEEN STRETCHED AND ELASTICALLY WEAKENED JUST DISTAL TO THE PORT CONNECTION. THERE WERE SEVERAL PERMANENT BENDS ALONG THE LENGTH OF BOTH SEGMENTS, BUT THESE BENDS DID NOT APPEAR TO AFFECT THE ELASTIC INTEGRITY OF THE TUBING. THE BROKEN ENDS OF THE TUBING HAD BEEN COMPRESSED AND PERMANENTLY FLATTENED. THE BREAK LINE WAS PERPENDICULAR WITH THE AXIS OF THE TUBING, AND APPEARED JAGGED AND BROKEN. THE BROKEN HALVES MATCHED WHEN THE ENDS WERE MATED. UNDER MAGNIFICATION, THE SEVERED SURFACE TEXTURE APPEARED ROUGH AND GRANULAR WITH RANDOM STRIATIONS ACROSS THE BROKEN PLANE. THE CROSS SECTIONS OF THE BROKEN TUBING HAD BEEN PERMANENTLY DEFORMED INTO OVAL SHAPES. THE OVAL CROSS SECTIONS WERE MEASURED USING A CALIBRATED MICROSCOPIC MICROMETER. THE LONGEST PART OF THE PROXIMAL SEGMENT'S BROKEN END OUTER DIAMETER MEASURED O.136", WITH AN OVAL WIDTH OF 0.106". THE LONGEST PART OF THE DISTAL SEGMENT'S BROKEN END OUTER DIAMETER CROSS SECTION MEASURED 0.132", WITH AN OVAL WIDTH OF 0.113". THESE SIGNS, ALONG WITH THE CIRCUMSTANCES OF THE MALFUNCTION, ARE TYPICAL OF A CLAVICLE/FIRST RIB COMPRESSION FRACTURE, A COMPLICATION ASSOCIATED WITH THE MEDIAL PLACEMENT OF THE CATHETER IN THE SUBCLAVIAN VEIN. THIS IS A RISK AGAINST WHICH THE MFR WARNS AGAINST IN ITS INSTRUCTIONS FOR USE.
THE CATHETER WAS INSERTED UNEVENTFULLY IN AN OB PT. ABOUT 1HR. AFTER DELIVERY, DIFFICULTY WAS ENCOUNTERED IN TRYING TO REMOVE THE CATHETER. AN X-RAY WAS TAKEN AND THE CATHETER WAS NOTED TO HAVE KNOTTED. IT WAS NECESSARY TO PERFORM A LAMINECTOMY TO SUCCESSFULLY REMOVE THE CATHETER. THERE WERE NO ADD'L PT COMPLICATIONS.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILURE TO INTEGRATE, DR WENT TO UNCOVER THE IMPLANT AND NOTICED IT DIDN'T INTEGRATE. PT IS REPORTEDLY FINE.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF SUSPECTED WIRE FRACTURE WITHOUT PROTRUSION. FAILURE ANALYSIS IS PROVIDED.
THIS ENTIRE FORM COMPLETED BY MFR. UNABLE TO PERFORM ANALYSIS. LEAD DAMAGED. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES NO "J" STIFFENER WIRE FRACTURES ALONG WITH NO COIL WIRE FRACTURES THROUGHOUT LEAD BODY. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS NO COIL WIRE OR "J" STIFFENER WIRE FRACTURES.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. ACCURATE MEASUREMENTS COULD NOT BE TAKEN SINCE ONLY A PORTION OF THE COMPONENT WAS RETURNED. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT AVAILABLE FROM THE DR.'S OFFICE.
THE DENTIST BURNED THE INSIDE OF A PT'S CHEEK WHILE DOING A ROUTINE CROWN. NO MEDICAL TREATMENT REQUIRED.
UNAUTHORIZED REPAIR USING NON CO DENTAL PARTS ON THE AUTOCHECK CARTRIDGE. BALL RETAINER VERY DRY. DR MAY NOT HAVE KNOWN TO LUBE HANDPIECE SINCE IT HAD A LF END CAP. BOTH THE FREQUENCY AND THE SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. IS FREQUENCY OF OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS FREQUENCY GREATER OF THIS EVENT THAN IS USUAL? NO. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. VISUAL: END CAP REJECTED: CORROSION ON END CAP. END CAP STAMPED LF. HANDPIECE CONDITION: DIRTY AND CORROSION INSIDE OF HOUSING. CORROSION ON HANDPIECE.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND LOOSENING OF THE COMPONENTS. THE FEMORAL COMPONENT AND PATELLA WERE ALSO REMOVED AT THIS TIME. NO REPLACEMENT COMPONENTS WERE USED.
AS RECEIVED, THE POROUS COATING OF THE TIBIAL BASEPLATE EXHIBITS VERY GOOD AND COMPLETE CEMENT AND BONE INTERDIGITATION WHICH IS CONTRATY TO EXPECTATIONS FOR THE REPORTED DEVICE LOOSENING. THE WEAR PATTERN INDICATES AN INTERNAL MAL-ROTATION MEASURED AT APPROXIMATELY 10 DEGREES, AND SUGGESTS A SLIGHT VARUS MALALIGNMENT. THE ALL PLASTIC PATELLAR COMPONENT SHOWS NEGLIGIBLE WEAR ON THE ARTICULATION SURFACE AND GOOD BONE CEMENT ADHESION. THE FEMORAL COMPONENT EXHIBITS SOME BURNISHING ON BOTH CONDYLAR SURFACES AND HAS GOOD AND COMPLETE BONE CEMENT INTERDIGITATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE AS THE LOT CODES HAVE NOT BEEN PROVIDED AND ARE NOT VISIBLE OR HAVE BEEN OBLITERATED ON THE PARTS. THE INFORMATION PROVIDED AND THE EXAMINATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH LOSS OF FIXATION AND MALALIGNMENT.
PNEUMATIC DRIVE LINE SEPARATION OF THE VENTRICULAR ASSIST DEVICE WITH PUMP THROMBOSIS DURING REIMPLANTATION. PRIOR IMPLANTATION OCCURRED ON 9/5/96.
IT IS REPORTED TO CO THAT WHILE BEING SUPPORTED BY CO'S LVAD, THE PT DEVELOPED SYMPTOMS OF AN AIR LEAK IN THE SYSTEM. THE PT WAS TAKEN TO THE OR AND REIMPLANTED WITH ANOTHER DEVICE. H6 DEVICE IS CURRENTLY BEING RECALLED. USER FACILITY MEDWATCH FORM RECEIVED 11/4/96.
THE DR REPORTEDLY EXPERIENCED A CORNEAL BURN WHILE USING THIS EQUIPMENT. IT WAS REPORTED THAT THE BURN MAY BE RELEASED TO TOO TIGHT WOUND. THEP T IS FINE AND THERE IS NO APPRECIABLE ASTYMATISM.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. F4 INFO NOT AVAILABLE. H4 PRODUCT WAS REFURBUSHED ON 11/29/95.
OR AXLE MAG W/NUT. DEALER ALLEGES QUICK RELEASE AXLE BROKE WHILE USER WAS RIDING THROUGH WOODS.
SURGERY CLINIC REPORTS CANNULAS CAME OFF IN 3 CASES AND THE VITREOUS WAS ALMOST LOST IN 1 CASE. ALL 3 PTS ARE DOING FINE. WHEN THE SURGEON DEPRESSED THE PLUNGER THERE WOULD BE SOME RESISTANCE SO HE WOULD KEEP PUSHING AND THEN THE CANNULA APPEARED TO TWIST AND THEN COME OFF.
ONE SYRINGE WAS RETURNED FOR EVALUATION. THE COMPONENTS MET SPECIFICATIONS AND PASSED ANSI GAGE TESTING. THERE HAVE BEEN NO REPORT FROM OTHER FACILITIES CONCERNING THIS LOT.
INTERNAL SCALP ELECTRODE WAS APPLIED BY DR IN INTERUS. REPORT FROM ANOTHER FACILITY THAT THE DURA WAS PENETRATED WITH LEAKAGE AND SUTURES PLACED.
DURING A CORONARY PROCEDURE, AN ARTERIAL PERFORATION OCCURRED. THE PERFORATION WAS SEALED WITH AN ANGIOPLASTY BALLOON.
THE PRODUCT WAS NOT RETURNED TO THE MFR. THEREFORE, NO PRODUCT EVAL COULD BE PERFORMED.
WHILE PT WAS UNDER MAC ANESTHESIA FOR A SUPRACLAVICULAR LYMPH NODE BIOPSY, PT SUSTAINED A FLASH BURN TO HER LEFT EAR CARTILAGE AND HAIRLINE. DRAPES WERE VENTED AND ONLY IN CONTACT AT HAIR LINE ON LEFT SIDE. PT'S HAIR WAS CONTAINED IN OR CAP. PT WAS BREATHING SPONTANEOUSLY WITH O2 FACE MASK AND IOL CRNA NOTED 5-6" FLAMES AND THE PT'S HAIR LINE AFTER A BOVIE "POP" WAS HEARD FROM INSIDE THE WOUND. INTERFIOR OF WOUND WAS CHARRED. BOVIE GROUND PAD WAS INTACT.
METAL SHAVINGS FOUND IN GLOVE. USER HAS CUT FINGERTIPS.
DEALER CLAIMS CHAIR HAS A BROKEN X-TUBE.
THE USER FACILITY REPORTED THAT THE INFANT WAS UNDER FOUR LBS AND THE AREA OF APPLICATION WAS SWOLLEN. THE PRODUCT LABELING CONTRAINDICATES APPLICATION TO THE FONTANELS OR IF ITS NOT POSSIBLE TO IDENTIFY CONTEMPLATED APPLICATION SITE.
REPORTER STATED, REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA.
SUMMARY OF EVALUATION: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS THEY HAVE NOT BEEN RETURNED TO CO BUT RATHER HAVE BEEN RETAINED BY THE PT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS WAS NOT POSSIBLE AS THE LOT CODES HAVE NOT BEEN PROVIDED. ATTEMPTS OT OBTAIN CATALOG NUMBERS AND LOT CODE INFORMATION HAVE BEEN UNSUCCESSFUL. THE MEDICAL OPINION STATES THAT THE WEAR APPEARED TO BE NORMAL FOR ITS 14 YRS OF USE.
REPORTER STATED, AFTER APPLICATION OF THE BONE CEMENT, THE PT BECAME BRADYCARDIC. CARDIAC ARREST FOLLOWED AND RESUSCITATION MEASURES WERE UNSUCCESSFUL.
SUMMARY OF EVALUATION: EVALUATION RESULTS SUGGEST THAT THIS EVENT IS PT RELATED. THE PT SUFFERED AN ADVERSE REACTION TO THE PRODUCT. THIS ADVERSE REACTION IS WELL KNOWN AND DOCUMENTED WITHIN THE PRODUCT LITERATURE.
ONE SYRINGE WAS RETURNED FOR EVALUATION. THE COMPONENTS MET SPECS AND PASSED ANSI GAGE TESTING. THERE HAVE BEEN NO SIMILAR REPORTS FROM OTHER FACILITIES CONCERNING THIS LOT.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. THE CLIPS DID NOT FORM PROPERLY. NO PT INJURY REPORTED.
11/4/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. CO'S FOREIGN SUBSIDIARY WAS INFORMED OF THIS EVENT ON 9/2/96. HOWEVER, CORPORATE WAS NOT INFORMED UNTIL 10/24/96. CO'S FOREIGN SUBSIDIARY WILL BE REINSTRUCTED REGARDING THE REPORTING REQUIRMENTS OF MDR REPORTING.
X-TUBE ASSM 17" X 16". DEALER ALLEGES X-TUBE BROKE AT THE BOLT HOLE.
WHILE PT WAS UNDER MAC ANESTHESIA FOR A SUPRACLAVICULAR LUMPH NODE BIOPSY, PT SUSTAINED A FLASH BURN TO HER LEFT EAR CARTILAGE AND HAIRLINE ON LEFT SIDE. PT'S HAIR WAS CONTAINED IN OR CAP. PT WAS BREATHING SPONTANEOUSLY WITH O2 FACE MASK AT IOL. CRNA NOTED 5-6" FLAMES AT THE PT'S HAIRLINE AFTER A BOVIE "POP" WAS HEAR FROM INSIDE THE WOUND. INTERIOR OF WOUND WAS CHARRED. BOVIE GROUND PAD WAS INTACT.
CO FAILS TO SEE ANY CONNECTON BETWEEN "A BOVIE POP FROM INSIDE THE WOUND" AND THE SUSPECT DEVICE. ALSO NOTE THAT THE GROUND PAD WAS INTACT. CO CAN NOT SEE HOW THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.
11/4/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. CO'S FOREIGN SUBSIDIARY WAS INFORMED OF THIS EVENT ON 9/2/96. HOWEVER, CO WAS NOT INFORMED UNTIL 10/24/96. CO'S FOREIGN SUBSIDIARY WILL BE REINSTRUCTED REGARDING THE REPORTING REQUIREMENTS OF MDR REPORTING.
PER THE INFO PROVIDED TO CO BY MEANS OF THE PT'S REP, THE DEVICE WAS REMOVED DUE TO AN "INFECTION".
ACCORDING TO THE RECEIVED INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 2/19/1993. ON 9/5/1996 A RECEIVED COMPLAINT FROM A PT REP STATED, "[THE PT] EXPERIENCED AN INFECTION AND THE IMPLANT WAS REMOVED IN 3/1993." THE PT REP HAS NOT PROVIDED A MEANS OR RELEASE TO CONTINUE WITH THIS INVESTIGATION. TO DATE, THIS COMPLAINT HAS NOT BEEN REPORTED BY A MEDICAL PROFESSIONAL OR CONFIRMED BY THE MFR. WITHOUT INFO FROM A MEDICAL PROFESSIONAL OR AN EXPLANTED DEVICE, QUALITY ASSURANCE IS PRECLUDED FROM COMMENTING ON THIS OCCURRENCE. SHOULD ADDITIONAL INFO AND/OR THE EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND RE-EVALUATED, ACCORDING TO PROCEDURES.
REPORTER STATED, THE CEMENT HARDENED PREMATURELY. THE PARTIALLY IMPLANTED FEMORAL COMPONENT AND EXCESS CEMENT WERE REMOVED AND RE-IMPLANTED. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
TPA BOLUS 15MG IV GIVEN. TPA INFUSION (85CC) INCREASED WITH TUBING MODEL 59093, H5115909316, LOT #605908 AND PLACED ON PUMP SET AT 100CC/HR WITH VTBI AT 50MG (50CC). APPROX. 1/2 HOUR AFTER INFUSION STARTED BOTTLE WAS EMPTY PUMP STILL INFUSING WITH VTBI NOTED TO HAVE 36 MG.
THE PUMP WAS RETURNED AND WAS VISUALLY AND FUNCTIONALLY TESTED AND FOUND TO MEET ALL MFR'S SPECIFICATIONS. THERE WAS NO VISUAL DAMAGE NOTED. THE ACCURACY AT THE REPORTED RATE OF 100 ML/HR WAS -3.7% AND WAS TESTED AT SEVERAL OTHER RATES AND PASSED ALL TESTS. IT IS SUSPECTED THAT A POSSIBLE MISLOAD OF THE IV SET MAY HAVE CAUSED THE REPORTED OVERINFUSION. ADD'L INSERVICING HAS BEEN SCHEDULED ON PROPER LOADING OF THE IV SET PER THE DIRECTIONS FOR USE.SECTIONS A-E ARE PER THE ATTACHED VOLUNTARY MEDWATCH REPORT RECEIVED FROM THE HOSPITAL WITH CORRECTIONS MADE TO SECTIONS D-1,2 TO REFLECT THE CORRECT BRAND NAME AND TYPE OF DEVICE. SECTION F WAS COMPLETED BY THE MFR. MFR'S REPORT DATE 9/19/96.
PLAINTIFF ALLEGES THAT SHE DEVELOPED SEVERE ILLNESS AND INJURIES TO THE SKIN, INCLUDING BUT NOT LIMITED TO SKIN DISCOLORATION, SORENESS, RASHES, RESPIRATORY AND/OR OTHER RELATED DISEASES, DISORDERS AND REACTIONS CAUSED BY EXTENDED EXPOSURE TO LATEX GLOVES MADE BY CO AS WELL AS, MANY OTHER GLOVE MFRS.
DATE SENT TO FDA: 11/7/96. B4 AND F8 IS THE DATE THAT THIS INFO WAS RECEIVED BY CO. G4 IS THE DATE THAT THIS INFO WAS RECEIVED BY CO. H6 "NA" WAS USED DUE TO NO SAMPLE, NO LOT NUMBER AVAILABLE FOR INVESTIGATION.
SUMMARY OF EVALUATION: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS THEY HAVE NOT BEEN RETURNED TO CO BY RATHER HAVE BEEN RETAINED BY THE PT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS WAS NOT POSSIBLE AS THE LOT CODES HAVE NOT BEEN PROVIDED. ATTEMPTS TO OBTAIN CATALOG NUMBERS AND LOT CODE INFORMATION HAVE BEEN UNSUCCESSFUL. THE MEDICAL OPINION STATES THAT THE WEAR APPEARED TO BE NORMAL FOR ITS 14 YRS OF USE.
11/4/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. CO'S FOREIGN SUBSIDIARY WAS INFORMED OF THIS EVENT ON 9/2/96. HOWEVER, CO WAS NOT INFORMED UNTIL 10/24/96. CO'S FOREIGN SUBSIDIARY WILL BE INSTRUCTED REGARDING THE REPORTING REQUIREMENTS OF MDR REPORTING.
THE PT, A IDDM, WAS NOT FEELING WELL ON 9/30. A 9:30/P READING ON HER METER WAS 84 MG/DL. SHE DID NOT TAKE HER EVENING DOSE OF 12U NPH INSULIN NOR DID SHE EAT DINNER BECAUSE SHE WAS FEELING ILL. A 3/A METER READING WAS 153 MG/DL. ON 10/1, THE PT WAS TRANSPORTED TO THE HOSP BY HER HUSBAND WHERE    LAB GLUCOSE RESULT OF 551 MG/DL WAS OBTAINED. HER METER READ 89 MG/DL 2 HOURS PRIOR TO THE LAB RESULT. NO INSULIN WAS TAKEN THAT MORNING. THE PT WAS ADMITTED AND TREATED WITH AN INSULIN DRIP AND POTASSIUM CHLORIDE. A METER TO LAB COMPARISON WAS PERFORMED WHILE IN THE HOSP: METER 54MG/DL, LAB 197 MG/DL. THE METER IS NOT CLEANED ACCORDING TO MFR'S FREQUENCY OR RECOMMENDATIONS. IT IS CLEANED ONLY WHEN IT DISPLAYS "CTA" AND IS CLEANED WITH A DRY CLOTH ONLY, NO WATER IS USED. CALIBRATION STATUS ON 10/3 WAS 81 VERSUS A RANGE OF 73/98.
IT WAS REPORTED THAT A BALLOON BURST ON THE FIRST INFLATION AT THREE ATMOSPHERES DURING A RENAL ANGIOPLASTY. A SECOND BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THIS DEVICE HAS NOT BEEN RETURNED FOR EVAL. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAK IS AN ANTICIPATED EVENT OF ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVER-PRESSURIZATION OR USE IN A CALCIFIED LESION. HOWEVER, WITHOUT EVALUATING THIS DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON CATHETER OCCURS DURING INFLATION OR IF THE BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY. INFLATION IN EXCESS FO THE RATED BURST PRESSURE MAY CAUSE BALLOON TO RUPTURE".
H6. 86 (OTHER) - MICROSCOPIC EXAMINATIONTHE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. DRIED FOREIGN MATTER WAS NOTED IN THE LUMEN. A PIN HOLE LEAK WAS NOTED IN THE BALLOON OVER THE PROXIMAL RO MARKER. SCRATCHES AND CATHETER MARKS WERE NOTED ON THE BALLOON SURFACE. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES AND CHATTER MARKS ON THE BALLOON SURFACE. THEREFORE, WE BELIEVE THIS FACTOR CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE.
CATHETER COULD NOT BE REMOVED BECAUSE BALLOON WOULD NOT DEFLATE. PHYSICAL PULLED CATHETER OUT TO REMOVED IT.
PT INITIALLY HAD KNEE ARTHROSCOPY WITH MENISCAL REPAIR ON 07/12/96. PT RE-ADMITTED TO HOSPITAL ON 07/12/96 WITH INFECTION AND JOINT FLUID IN LEFT KNEE. DEBRIDEMENT PERFORMED ON 07/29/96 AND DISCHARGED ON 08/10/96 AFTER IV ANTIBIOTIC THERAPY.
SAMPLE OF MATERIAL IN QUESATION CURRETNLY UNDERGOING STERILITY TESTING. UPON COMPLETION OF TESTING, SUPPLEMENT WILL PROVIEDED WITH APPLICABLE EVALUATION CODES.
H6- FINISHED GOODS STERILITY TESTING ON THE SAMPLES OF THE ABOVE STATED PRODUCT CODE AND BATCH NUMBER RETURNED WAS COMPLETED WITH ALL STERILE RESULTS.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. THE INSTRUMENT BROKE AND WOULD NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/17/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN E1.
THE STAFF HAD A PROBLEM CLEARING THE CATHETER LINE AND A PORT-A-CATHOGRAM WAS DONE. THIS SHOWED A CATHETER FRAGMENT. THE PT WAS ADMITTED TO THE OUTPATIENT SPECIAL PROCEDURES DEPT. FOR RETRIEVAL OF THE CATHETER FROM THE RIGHT VENTRICLE. THIS WAS UNEVENTFUL.
THE DEVICE WAS USED DURING A LAPARAOSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SCOPE'S VISIBILITY WAS POOR. THE SURGEON USED ANOTHER SCOPE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/4/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
ON 10/9/96, A FACILITY NURSE INFORMED A MFR CUSTOMER SERVICE REP THAT THE PT'S DEVICE REFILL CYCLE WAS ON TARGET; HOWEVER, RECENTLY THE FACILITY NURSE HAS NOT BEEN RECEIVING ANY RESIDUAL VOLUME DURING THE DEVICE REFILL PROCEDURE. ADDITIONALLY, THE FACILITY NURSE STATED THAT THE PT HAS COMPLAINED THAT HE WAS FALLING ASLEEP IN HIS CHAIR. THE DEVICE WAS EXPLANTED AND REPLACED ON 10/7/96.
THIS DEVICE WAS IMPLANTED FOR INTRATHECAL INFUSION OF MORPHINE FOR TREATMENT OF PAIN (NOTE: INTRATHECAL INFUSION OF MORPHINE WAS NOT AN INDICATION OF THE MFR'S INTENDED USE). THE DEVICE WAS RETURNED TO THE MFR ON 11/1/96, AND HAS BEEN ANALYZED AS FOLLOWS: NORMAL USAGE WAS SEEN ON THE CENTER AND SIDEPORT SEPTA WITH NO INTERNAL FRACTURE PLANE DAMAGE NOTED. THE DEVICE CENTER SPETUM DID NOT LEAK WHILE FILLING THE DEVICE RESERVOIR OR WHILE PRESSURIZING THE DEVICE SIDEPORT. NO RESISTANCE WAS ENCOUNTERED UPON FLUSHING THE DEVICE SIDEPORT WITH APPROXIMATELY 5MLS OF PRESERVATIVE FREE SALINE AND APPROXIMATELY 5MLS OF CLEAR COLORLESS "PARTICLE FREE FLUID" WHICH TESTED NEGATIVE FOR BLOOD WAS COLLECTED. LEAK TESTING OF THE DEVICE CONFIRMED THAT THE DEVICE/DEVICE CATHETER DID NOT LEAK. THE DEVICE FLOWED WITH THE MFR'S FLOW RATE SPECIFICATIONS AS RECEIVED. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT INDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT FOR THIS DEVICE. BASED ON THE INFORMATION AVAILABLE AND THE RESULTS OF THE MFR'S ANALYSIS, THE CUSTOMER'S COMPLAINT THAT "THE DEVICE APPEARS TO BE LEAKING" COULD NOT BE CONFIRMED, THE DEVICE PERFORMED AS INTENDED DURING THE MFR'S INVESTIGATION. THE CUSTOMER WILL BE NOTIFIED OF CO'S FINDINGS. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SCOPE'S VISIBILTY WAS POOR. THE SURGEON USED ANOTHER SCOPE TO COMPLETE THE RPOCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/4/96- MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
THE INNER CANNULA WOULD NOT SNAP INTO POSITION. A SECOND DEVICE WAS USED WITHOUT FURTHER PROBLEMS. NO PT INJURY WAS REPORTED. THIS COMPLAINT WAS REPORTED TO CO'S FACILITY BY A DISTRIBUTOR ALTHOUGH THE INCIDENT OCCURRED ON 19 SEPT, THE SAMPLES WERE NOT REC'D BY FACILITY UNTIL 7 10/96. ATTEMPTS TO OBTAIN ADD'L INFO THROUGH THE DISTRIBUTOR HAVE BEEN UNSUCCESSFUL.
THE REPORT THAT THE INNER CANNULA WOULD NOT SNAP INTO POSITION COULD NOT BE VERIFIED. MEASUREMENTS OF THE TORQUE REQUIRED TO LOCK AND UNLOCK THE INNER AND OUTER CANNULAE WERE WITHIN CO'S SPECIFICATIONS. A LOT NUMBER REVIEW OF THE MANUFACTURING RECORDS, PRODUCT COMPLAINTS, AND DEVICE HISTORY RECORDS WAS CONDUCTED AND NO RELATED DISCREPANCIES OR NONCONFORMANCES WERE FOUND ASSOCIATED WITH THE SAME LOT.
X-TUBE ASSEMBLY 16" X 18". DEALER ALLEGES X-TUBE BRACE IS BROKEN AT CTR BOLT.
HIGH STRESS FACTOR AT CTR & ENDS OF X-TUBE. SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SCOPE'S VISIBILITY WAS POOR. THE SURGEON USED ANOTHER SCOPE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
90 Y.O. TAKEN TO O.R. FOR REPAIR OF FX LEFT HIP (FEMORAL NECK FX). PT GIVEN SPINAL ANESTHESIA. WHEN CEMENT IN CENTRIFUGE PT EXPERIENCED SUDDEN HYPOTENSION AND RESUSCITATED (INTUBATED, ETC.) OPERATIVE PROCEDURE CONTINUED. PT'S BP INCREASED AFTER 15 MIN AND TAKEN TO PACU WHERE BP AGAIN DECREASED (PALPABLE 50). VASOPRESSORS/TRANSFUSIONS/INTUBATION/ETC CONTINUED AND PT TRANSFERRED TO ICU AFTER APPROX 3 1/2 HRS (9A-12:30P PACU). AFTER A COUPLE HRS. IN ICU FAMILY INFORMED OF POOR PROGNOSIS ELECTED TO REMOVE LIFE SUPPORT & PT. EXPIRED 3:30P 8/27.
THE IAB WAS INSERTED INTO THE PT ON 10/98/96. ON 10/10/96, THE "RAPID GAS LOSS" ALARM SOUNDED FROM THE PUMP THREE TIMES. THEN, BLOOD WAS NOTED IN THE TUBING. THE DR TRIED TO REMOVE THE IAB BUT WAS UNABLE TO. AS A RESULT OF THE EVENT, THE PT WENT TO THE O.R. TO HAVE THE IAB SURGICALLY REMOVED. THE CONTACT REMARKED THAT THE IAB WAS STUCK ON SOME PLAQUE. ON 10/18/96, CO WAS NOTIFIED THAT THE IAB WAS PROBABLY DISCARDED.
SECTION F: INFO HAS BEEN REQUESTED FROM THE USER FACILITY AND IS UNOBTAINABLE. THE TIBIAL COMPONENT AND PATELLAR COMPONENT CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS THEY HAVE NOT BEEN RETURNED TO HOWMEDICA BUT RATHER HAVE BEEN RETAINED BY THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE TIBIAL COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. THE LOT CODE FOR THE PATELLAR COMPONENT IS APPARENTLY INCORRECT SO THAT A REVIEW OF ITS DEVICE HISTORY RECORD IS NOT POSSIBLE.
PER THE INFO PROVIDED TO CO BY MEANS OF THE PT'S REP, THE DEVICE WAS REMOVED AS THE "DEVICE FAILED TO INFLATE. A LEAK WAS DISCOVERED AT THE TIME OF REMOVAL". ADD'L SER NO: 012169.
ACCORDING TO THE RECEIVED INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 8/12/1987. ON 9/5/1996 A RECEIVED COMPLAINT FROM A PT REP STATED, "THE DEVICE EVENTUALLY FAILED TO INFLATE. A LEAK WAS DISCOVERED IN THE RESERVOIR AT THE TIME OF ITS REMOVAL IN 1989." THE PT REP HAS NOT PROVIDED A MEANS OR RELEASE TO CONTINUE WITH THIS INVESTIGATION. TO DATE, THIS COMPLAINT HAS NOT BEEN REPORTED BY A MEDICAL PROFESSIONAL OR CONFIRMED BY THE MFR. WITHOUT INFO FROM A MEDICAL PROFESSIONAL OR THE EXPLANTED DEVICE, QUALITY ASSURANCE IS PRECLUDED FROM COMMENTING ON THE STATUS OF THIS DEVICE. SHOULD ADDITIONAL INFO AND/OR THE EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND RE-EVALUATED, ACCORDING TO PROCEDURES.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT HOLD. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP REPORTED THAT NO PT INJURY OCCURRED.
X-TUBE ASSEMBLY 20" X 18". DEALER CLAIMS X-TUBE BROKE AT LEFT TOP RAIL AND THE RIGHT BOTTOM.
HIGH STRESS FACTOR AT CTR & ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
EVALUATIN RESULTS SUGGEST THAT THIS EVENT IS PATIENT RELATED. THE PATIENT SUFFERED AN ADVERSE REACTION TO THE PRODUCT. THIS ADVERSE REACTION IS WELL KNOWN AND DOCUMENTED WITHIN THE PRODUCT LITERATURE.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED DUE TO THE RIGHT CYLINDER LEAKING. ADD'L LOT/SER# 0314Q 015.
DURING A DIALYSIS TREATMENT, THERE WAS AN EXTERNAL BLOOD LEAK AT THE SEALING PLUG ABOVE THE LABEL. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
INVESTIGATION/DETERMINATION OF CAUSE: SAMPLES RECEIVED FROM SAME LOT NUMBER WERE TESTED IN SIMULATED DIALYSIS WITH BOVINE BLOOD OR A COLORED WATER SOLUTION IN THE BLOOD COMPARTMENT OF DIALYZER. THIS TEST WAS TO DETECT ANY LEAKS IN SEALING PLUG AREA. TESTS ARE DONE ACCORDING TO REQUIREMENTS ANSI/AAMI STANDARD FOR FIRST USE HEMODIALYZERS USING A PRESSURE IN BLOOD COMPARTMENT WHICH IS 1.5 TIMES STATED MAXIMUM ALLOWABLE PRESSURE FOR ACTUAL DEVICE. RESULT FROM TEST INDICATED A SMALL LEAK (FEW DROPLETS) AT SEALING PLUG ON ONE DIALYZER WHEN DIALYZER WAS TESTED WITH COLORED WATER SOLUTION. NO LEAKS OCCURRED DURING TEST WITH BOVINE BLOOD. INVESTIGATION OF LEAKING DIALYZER CONFIRMED A SMALL DAMAGE ON SURFACE OF SEALING PLUG. A REVIEW AND INVESTIGATION OF PROCESS EQUIPMENT USED TO MANUFACTURE PLUG AS WELL AS PLUGGING STATION IN DIALYZER ASSEMBLY LINE WERE DONE TO FIND POSSIBLE REASONS FOR DEFECTS OR SMALL DAMAGES TO SEALING PLUG WHICH OCCASIONALLY MAY CAUSE LEAKAGE. PLUGGING STATION DESIGN WAS REVIEWED AND A SMALL CHANGE WAS DONE TO PLUG ENTRANCE CHANNEL TO FACILITATE MOVEMENT OF PLUG AND AVOID RANDOM DAMAGES. ACIVITIES ON PLUGGING STATION WERE DONE ON 10/3/96. ADJUSTMENTS OF COMPLETE PLUGGING STATION HAVE EARLIER BEEN RECHECKED ON 8/9/96. FOLOW-UP ACTION: AS PART OF A CONTINUING IMPROVEMENT PROGRAM, MOULDING TOOL FOR PLUG WAS POLISHED TO AVOID ANY OCCURRENCE OF SURFACE ROUGHNESS. THIS ACTION IMPLEMENTED 9/2/96 WILL FAICLITATE MOVEMENT OF PLUG IN PLUG STATION AND REDUCE ANY POSSIBILITES FOR RANDOM DAMAGES TO PLUG. MFR WILL CONTINUE OT MONITOR AND TREND.
EVAL: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVAL INSPITE OF NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR THE RETURN OF THE PRODUCT. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 5/12/98).
THE PUMP ALARM SOUNDED. THE IAB LEAKED. THE BALLOON HAD TO BE SURGICALLY REMOVED FROM THE PT. INSPITE OF NUMEROUS CALLS TO THE FACILITY, THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVAL. [EVENT COMPLICATIONS]: IAB BECAME ENTRAPPED/SURGICAL REMOVAL REQUIRED-RPT'D 10/11/96. [PT'S CURRENT STATUS]: UNK-RPT'D 10/11/96.
THE DEVICE WAS USED DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE. THE STAPLES DID NOT FOLD. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REQUESTED THAT NO PT INJURY OCCURRED.
ON 7/23/85 DEVICE WAS IMPLANTED. ON 12/20/85 THE CYLINDERS WERE REVISED. ON 10/1/96 THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS IMPLANTED DUE TO INFECTION.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL.
THE PRODUCT WAS USED DURING A HERNIA REPAIR PROCEDURE. THE SUTURE BROKE AS KNOTS WERE BEING TIED. NO PT INJURY REPORTED. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE.
INFECTION-ABSCESS LEADING TO DEHISCENCE REQUIRING REMOVAL OF UNABSORBED SUTURE.
H3 INSUFFICIENT SAMPLE PROVIDED FOR TESTING REQUIREMENTS. BATCH HISTORY RECORD REVIEW IS BEING CONDUCTED. REGULATIONS REQUIRE REPORTING WHEN THE SAME DEVICE FAMILY AND NATURE OF EVENT WAS PREVIOUSLY REPORTED AS A REPORTABLE EVENT.
THIS CATHETER WAS BEING UTILIZED FOR A DIAGNOSTIC CARDIOLOGY PROCEDURE WHEN THE CATHETER PROLAPSED ONTO ITSELF AT THE TIP/SHAFT JUNCTION. THE CATHETER WAS SUCCESSFULLY UNTANGLED WITH A GUIDEWIRE AND REMOVED FROM THE PT WITHOUT FURTHER INCIDENT. THERE WAS NO REPORTED INJURY TO THE PT.
TEST RESULTS: NO PRODUCT WAS RETURNED FOR EVALUATION. A RESERVE SAMPLE FROM LOT M288820 WAS EVALUATED FOR INNER AND OUTER DIAMETER MEASUREMENTS AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. THERE WERE NO STIFFNESS SPECIFICATIONS FOR THIS LOT OF CATHETERS AT THE TIME OF MFR. THE LOT HISTORY RECORDS WERE REVIEWED WITH NO REJECTS NOTED WHICH HAVE CONTRIBUTED TO THE EVENT. THE ADDITIONAL INFO PROVIDED IN SECTION F WAS SUPPLIED BY MALLINCKRODT INC.
X-TUBE ASSEMBLY 20" X 16". DEALER CLAIMS X-TUBE BROKE AT CENTER BOLT.
HIGH STRESS FACTOR AT CTR & ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE IAB WAS INSERTED INTO THE PT WITHOUT A SHEATH. AFTER IABP FOR 10 MINUTES, AN ALARM SOUNDED FROM THE SYSTEM 90T PUMP. PUMPING WAS INITIATED AGAIN BUT THE PUMP WOULD NOT START. THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER. A GUIDE WAS NOT INSERTED, SO THE IAB WAS REMOVED SURGICALLY. THERE WERE NO OTHER COMPLICATIONS FROM THE EVENT. (EVENT COMPLICATIONS: THE IAB WAS SURGICALLY REMOVED - REPORTED 10/11/96. PT'S CURRENT STATUS: UNK-RPT'D 10/11/96).
THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE BALLOON COMPLETELY UNFOLDED. LABORATORY EXAMINATION ON THE RETURNED ITEM REVEALED NO DEFECTS. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. AS A TEST, THE IAB WAS PLACED IN A TEST CHAMBER HAVING A 75 MMHG BACK PRESSURE TO SIMULATE THE PRESSURE WITHIN THE AORTA. THE IAB FULLY INFLATED AND FUNCTIONED NORMALLY WHEN ATTACHED TO THE SYSTEM 90 IABP IN THE LABORATORY. NO ALARMS WERE TRIGGERED ON THE PUMP. AFTER 2 MINUTES OF PUMPING, PRESSURE STRIPS WERE RECORDED. THE STRIPS CONFIRMES THAT THE BALLOON FULLY INFLATED AND DEFLATED SATISFACTORILY AT 80 AND 160 BPM DURING LABORATORY IABP TESTING. THUS, LABORATORY EXAMINATION REVEALED NO DEFECTS IN THE RETURNED IAB. PROBABLE CAUSE OF DIFFICULTY: NO LEAK WAS FOUND IN THE RETURNED IAB. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED DIFFICULTY BASED ON THE EVENT DESCRIPTION AND EXAMINATION. ALTHOUGH CONJECTURAL, THE PUMP ALARMS MAY HAVE BEEN PUMP RELATED.
ADMINISTRATOR MENTIONED THAT A PT WAS CLAIMING THAT HER BREAST IMPLANT WAS RUPTURED DURING A MAMMOGRAPHIC EXAM, USING SYSTEM.
THE DEVICE WAS TESTED/EVALUATED BY THE DEALER. THE DEVICE HAD NO DEFECT.
INVESTIGATION/DETERMINATION OF CAUSE: SAMPLES RECEIVED FROM SAME LOT NUMBER WERE TESTED IN SIMULATED DIALYSIS WITH BOVINE BLOOD OR A COLORED WATER SOLUTION IN BLOOD COMPARTMENT OF DIALYZER. THIS TEST WAS TO DETECT ANY LEAKS IN SEALING PLUG AREA. TESTS ARE DONE ACCORDING TO REQUIREMENTS IN ANSI/AAMI STANDARD FOR FIRST USE HEMODIALYZERS USING A PRESSURE IN BLOOD COMPARTMENT WHICH IS 1.5 TIMES STATED MAXIMUM ALLOWABLE PRESSURE FOR ACTUAL DEVICE. THE RESULT FROM TEST INDICATED A SMALL LEAK (FEW DROPLETS) AT SEALING PLUG ON ONE DIALYZER WHEN DIALYZER WAS TESTED WITH COLORED WATER SOLUTION. NO LEAKS OCCURRED DURING TEST WITH BOVINE BLOOD. INVESTIGATION OF LEAKING DIALYZER CONFIRMED A SMALL DAMAGE ON SURFACE OF SEALING PLUG. A REVIEW AND INVESTIGATION OF PROCESS EQUIPMENT USED TO MANUFACTURE PLUG AS WELL AS PLUGGING STATION IN DIALYZER ASSEMBLY LINE WERE DONE TO FIND POSSIBLE REASONS FOR DEFECTS OR SMALL DAMAGES TO SEALING PLUG WHICH OCCASIONALLY MAY CAUSE LEAKAGE. PLUGGING STATION DESIGN WAS REVIEWED AND A SMALL CHAGE WAS DONE TO PLUG ENTRANCE CHANNEL TO FACILITATE MOVEMENT OF PLUG AND AVOID DAMAGES. ACTIVITIES ON PLUGGING STATION WERE DONE ON 10/3/96. ADJUSTMENTS OF COMPLETE PLUGGING STATION HAVE EARLIER BEEN RECHECKED ON 8/9/96. FOLLOW-UP ACTION: AS PART OF A CONTINING IMPROVEMENT PROGRAM, MOULDING TOOL FOR PLUG WAS POLISHED TO AVOID ANY OCCURRENCE OF SURFACE ROUGHNESS. THIS ACTION IMPLEMENTED 9/2/96 WILL FACILITATE MOVEMENT  OF PLUG IN PLUG STATION AND REDUCE ANY POSSIBILITIES FOR RANDOM DAMAGES TO PLUG. THE MFR WILL CONTINUE TO MONITOR AND TREND.
THE PRODUCT WAS USED DURING A HERNIA REPAIR PROCEDURE. THE SUTURE BROKE AS KNOTS WERE BEING TIED. NO PT INJURY REPORTED. THE SURGEON APPLIED ANOTHER  SUTURE TO COMPLETE THE PROCEDURE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS IN THE RIGHT CYLINDER. ADD'L LOT/SER# 2826T 005.
THE SUTURE WAS USED FOR AN UNSPECIFIED UROLOGICAL PROCEDURE. THE SURGEON COMPLAINED THE SUTURE WAS PARTIALLY ABSORBED. NO PT INJURY REPORTED.
PER THE INFO PROVIDED TO CO BY MEANS OF THE PT'S REP, THE DEVICE WAS REMOVED DUE TO "INFECTION".
ACCORDING TO THE RECEIVED INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 1/14/1988. ON 9/5/1996 A RECEIVED COMPLAINT FROM A PT REP STATED, "THE DEVICE WAS REMOVED IN 5/1988 DUE TO AN INFECTION." THE PT REP HAS NOT PROVIDED A MEANS OR RELEASE TO CONTINUE WITH THIS INVESTIGATION. TO DATE, THIS COMPLAINT HAS NOT BEEN REPORTED BY A MEDICAL PROFESSIONAL OR CONFIRMED BY THE MFR. WITHOUT INFO FROM A MEDICAL PROFESSIONAL OR AN EXPLANTED DEVICE, QUALITY ASSURANCE IS PRECLUDED FROM COMMENTING ON THIS OCCURRENCE. SHOULD ADDITIONAL INFO AND/OR THE EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND RE-EVALUATED, ACCORDING TO PROCEDURES.
X-TUBE ASSEMBLY 18" X 17". DEALER CLAIMS X-TUBE BROKE AT THE WELD.
ON 4/15/85 DEVICE WAS IMPLANTED. ON 2/5/90 THE RESERVOIR WAS REVISED. ON 10/1/96 ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
REPORTER STATED, THE PT WAS CHRONICALLY DISLOCATING. REVISION SURGERY REVEALED ANTEVERSION OF THE ACETABULAR CUP. THE ACETABULAR INSERT, FEMORAL HEAD COMPONENT, AND FEMORAL STEM WERE ALSO REMOVED AT THIS TIME.
SUMMARY OF EVALUATION: EVALUATION OF THIS EVENT CAN NOT BE PERFORMED AS THE PROSTHESIS HAS NOT BEEN RETURNED TO CO. THE DEVICE HAS BEEN RETAINED BY THE PATIENT. THE DEVICE HISTORY RECORDS FOR THE ACETABULAR INSERT, SHELL, AND FEMORAL HEAD COMPONENT WERE REVIEWED AND NO DISCREPANCIES WERE OBSERVED. TEH LOT CODE PROVIDED FOR THE FEMORAL COMPONENT WAS NOT VALID; THEREFORE, A REVIEW OF ITS DEVICE HISTORY RECORD WAS NOT POSSIBLE. THE INFORMATION PROVIDED SUGGESTS THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE BUT RATHER WOULD BE RELATED TO THE POSITION OF THE IMPLANTED PROSTHESIS. THE POSITION OF THE IMPLANTED FEMORAL STEM AND ACETABULAR SHELL WERE THE REASON THE PROSTHESIS DISLOCATED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC COLPO SUSPENSION PROCEDURE. THE SUTURE IN THE DISPOSABLE LOADING UNIT BROKE DURING USE. NO PT INJURY REPORTED.
THE LEAD IS OVERSENSING AND WILL BE REPLACED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TOP FLUID LOSS - CYLINDERS. ADD'L LOT/SER# 4205J 013.
THE IAB WAS INSERTED INTO THE PT ON 10/5/96. ON 10/6/96, THE "LEAK IN IAB" ALARM SOUNDED FROM THE PUMP AND 10 MINUTES LATER BLOOD WAS NOTED IN THE TUBING. ON 10/23/96, CO WAS NOTIFIED AS A RESULT OF THE EVENT, THE PT'S BLOOD PRESSURE DROPPED AND THE PT WENT INTO CARDIOGENIC SHOCK. THE PT WENT ON TO EXPIRE  ON 10/6/96. THE IAB WAS NOT RETURNED TO CO FOR EVAL. THE IAB WAS DISCARDED BY THE FACILITY. (EVENT COMPLICATIONS: UNK RPT'D 10/11; DROP IN BLOOD PRESSURE/EXPIRED RPT'D 10/23/96). PT'S CURRENT STATUS: EXPIRED RPT'D 10/23/96.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVAL. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. ANY ADD'L INFO REVIEVED BY CO WILL BE SUBMITTED. LABEL CODE: 1738.
INVESTIGATION CONDUCTED. DR DOES NOT CITE A CAUSE FOR FAILURE, THEREFORE, IT'S UNKNOWN. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING SUCTIONING THE RESPIRATORY THERAPIST COULD NOT INSERT THE CATHETER INTO THE TRACHEOSTOMY TUBE. THE INNER CANNULA WAS REMOVED AND FOUND TO BE KINKED. NO PT INJURY OCCURRED. IT WAS NOT REPORTED HOW LONG THE DEVICE HAD BEEN IN USE. NB. ALTHOUGH THE COMPLAINT WAS REC'D ON 9/17/96, IT WAS NOT UNTIL THE PRODUCT WAS REC'D AND CONTENTS (INCLUDING THE LETTER DESCRIBING THE COMPLAINT) WERE DECONTAMINATED THAT THE NATURE OF THE REPORTED DEVICE "DEFECT" COULD BE IDENTIFIED. THE DEVICE AND LETTER WERE NOT REC'D UNTIL 10/7/96; THE LETTER WAS AVAILABLE ON 10/15/96.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "NO", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "NO", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
REPORTER STATED, REVISION SURGERY REVEALED SHEARING OF THE PATELLA FIXATION PEGS.
THE PATELLAR COMPONENT CAN NOT BE EVALUATED FOR THE REPORTED PEG SHEARING AS IT HAS NOT BEEN RETURNED TO CO BUT RATHER HAS BEEN DISCARDED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PATELLAR COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. THE INFO PROVIDED IN THE MEDICAL OPINION STATED THAT THE PATIENT DOES A LOT F SQUATTING AND SOMETIMES KNEELING. THESE FACTORS COULD CONTRIBUTE TO THE REPORTED PEG BREAKAGE.
PT HAVING EGD WHEN LASER SMOKE EVACUATOR FAILED. PROCEDURE TERMINATED.
PUMP PERFORMED WITHIN SPECS. CYLINDER HAD TORN FABRIC AND BULGING. CYLINDER HAD TORN FABRIC AND BULGING.
DEVICE IMPLANTED APPROX 6 YEARS AGO. REVISION SURGERY WAS PERFORMED ON 9/16/96, DUE TO WEAR, POSSIBLE MALALIGMENT.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. NO REMEDIAL ACTION WILL BE TAKEN. THE DEVICE WAS NOT RETURNED TO CO FOR EVALUATION. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
THE DEVICE WAS USED DURING A ROUX-EN-Y PROCEDURE. THE STAPLE LINE LEAKED POST OPERATIVELY. A RE-OPERATION WAS PERFORMED AND SUTURE WAS APPLIED TO COREECT THIS CONDITION. THE HOSP HAS REPORTED THE PT'S STATUS IS SATISFACTORY.
11/6/96 - MEDWATCH REPORT NOT RECEIVED BBY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
REPORTER STATED, THE PT EXPERIENCED DECREASING RANGE OF MOTION AND PAIN. REVISION SURGERY REVEALED POLYEHYLENE WEAR OF THE TIBIAL INSERT.
EVALUATION OF THIS DEVICE CANNOT BE PERFORMED FOR THE REPORTED WEAR AS IT HAS NOT BEEN RETURNED TO CO BUT RATHER HAS BEEN DISCARDED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS THE LOT CODE SUPPLIED IS APPARENTLY INCORRECT. THE MEDICAL OPINION PROVIDED STATES THAT THE POLY LOOKED REMARKABLY GOOD FOR THE 14 YEAR IMPLANTATION PERIOD EXCEPT FOR SOME DELAMINATION.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE FATIGUE FRACTURE OF THE OUTER COIL WAS THE RESULT OF SUBCLAVIAN STRESS. A COMPETITOR SENT THIS DEVICE BACK TO CO AS IT WAS MISTAKENLY SENT TO THEM. DATA FOR FIELD G.4. G. 4 IS BLANK. IT SHOULD READ 08/29/96. THIS IS THE DATE THAT THE DEVICE WAS ANALYZED WHEN IT WAS ORIGINALLY RETURNED, THERE WAS NO INDICATION OF A MALFUNCTION.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE MIDDLE BOLT.
HIGH STRESS FACTOR AT CTR & ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ON 5/28/93 DEVICE WAS IMPLANTED. ON 7/29/94 THE CYLINDERS WERE REVISED. ON 11/7/94 THE CONNECTORS WERE REVISED. ON 9/27/96 THE DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO INFECTION.
THE DEVICE WAS USED DURING A LOBECTOMY PROCEDURE. A COMPONENT DISENGAGED FROM THE INSTRUMENT AND WAS RETRIEVED. NO PT INJURY REPORTED.
11/4/96-MEDWATCH REPORT NOT RECEIVD BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS TUBE BROKE AT THE CTR BOLT.
ON 10/1/96, AFTER AN AVR OPERATION, THE DR INSERTED AN IAB WITH DIFFICULTY. IT WAS REPORTED THAT THE PT HAD CALCIFICATION. ON 10/4/96, THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER. THE DR HAD DIFFICULTY REMOVING THE IAB SO THE IAB WAS SURGICALLY REMOVED. THERE WAS NO ALARM FROM THE PUMP. (EVENT COMPLICATIONS: IAB ENTRAPPED/THE IAB WAS SURGICALLY REMOVED RPT'D 10/14/96. PT'S CURRENT STATUS: UNK RPT'D 10/14/96.
THIS FORM WAS COMPLETED BY THE MFR. SECTION  F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. EVALUATION SUMMARY: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. THE PHYSICAL EVIDENCE AND REPORTED PROBLEM ARE CONSISTANT WITH THAT OF AN IAB WHICH BECAME ENTRAPPED AND NEEDED TO BE SURGICALLY REMOVED FROM THE PATIENT. THE SMOOTH-EDGED MEMBRANE PENETRATION(S) MOST LIKELY RESULTED DURING BALLOON REMOVAL FROM THE PATIENT WHEN THE IAB CAME IN CONTACT WITH A SHARP-EDGED INSTRUMENT. ALTHOUGH THE PATIENT CONSEQUENCES OF BALLOON PENETRATION REMAIN OVERWHELMINGLY BENIGN, GENERALLY NECESSITATING ONLY THE REMOVAL OF THE BALLOON AND ITS POSSIBLE REPLACEMENT, THE MEDICAL COMMUNITY IS BECOMING INCREASINGLY AWARE OF THE "ENTRAPPED BALLOON" PHENOMENON. SINCE IT IS POSSIBLE FOR A SMALL LEAK TO BE SELF LIMITING, THE BLOOD WITHIN THE BALLOON MAY DEYHDRATE UNDER THE CONTINUED ACTION OF HELIUM TO FORM A HARD CLOT DURING INTRA-AORTIC BALLOON PUMPING, BEFORE ENOUGH BLOOD ENTERS TO BECOME VISIBLE IN THE CATHETER. THIS CLOT MAY CAUSE THE BALLOON TO BECOME TOO LARGE FOR PERCUTANEOUS REMOVAL OR TO BECOME "ENTRAPPED" IN THE ARTERY. BALLOON ENTRAPMENT NECESSITATING SURGICAL REMOVAL HAS BEEN REPORTED IN LITERATURE AND HAS BEEN EXPERIENCED BY USERS OF INTRA-AORTIC BALLOONS. CO THEREFORE URGE THE USER, AS CO HAS IN CO'S INSTRUCTIONS, TO DISCONTINUE PUMPING AND CONSIDER THE REMOVAL OF THE BALLOON FROM THE PATIENT AT ONCE IF A BALLOON LEAK IS SUSPECTED. IF FOR ANY REASON, UNDUE RESISTANCE IS MET DURING REMOVAL OF THE BALLOON, YOU WOULD BE WELL ADVISED TO CALL FOR A VASCULAR CONSULTATION, AS WAS DONE IN THIS CASE.
SOMETIME IN 1978 DEVICE WAS IMPLANTED. ON 10/1/96 THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
THE DEVICE WAS USED DURING A ROUX-EN-Y PROCEDURE. THE STAPLE LINE LEAKED POST-OPERATIVELY. A RE-OPERATION WAS PERFORMED AND SUTURE WAS APPLIED TO CORRECT THIS CONDITION. THE HOSP HAS REPORTED THE PTS STATUS IS SATISFACTORY.
11/6/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
REPORTER STATED, REVISION SURGERY REVEALED BREAKAGE OF THE TIBIAL BEARING COMPONENT.
SUMMARY OF EVALUATION: THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ABNORMAL LOADING OF THE DEVICE AND FATIGUE.
IMPLANTED IN 12/89. REVISION SURGERY WAS PERFORMED ON 9/23/96, DUE TO DISLOCATION.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATES THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THE DEVICE WAS NOT RETURNED TO CO FOR EVALUATION. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
THE DEVICE WAS USED DURING A VATS PROCEDURE. THE CLIPS DID NOT FORM PROPERLY. NO PT INJURY REPORTED.
11/4/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITAL REPORT TO FDA.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO A NON-FUNCTIONING DEVICE. ADD'L LOT/SER# 0466J 001.
PUMP PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. RESERVOIR HAD A WEAR LEAK.
THE DEVICE WAS USED DURING A LUNG REDUCTION PROCEDURE. THE STAPLES DID NOT RELEASE FROM THE INSTRUMENT WHEN FIRED. THE SURGEON RELOADED THE INSTRUMENT AND COMPLETED THE PROCEDURE WITHOUT INCIDENT.
NEEDLE WAS MISSING FROM THE PACK. DEFECT WAS DISCOVERED DURING SETUP PRIOR TO SURGERY; NO EFFECT ON PT.
WHILE PTA OF RIGHT RENAL ARTERY WAS BEING PERFORMED THE STENT WAS PLACED AND CO'S BALLOON WAS DEPLOYED. THE BALLOON GOT STUCK IN THE STENT, DID NOT UNWRAP CORRECTLY AND SUBSEQUENTLY BROKE. MULTIPLE ATTEMPTS WERE MADE WITH THE SNARE TO RETRIEVE THE BALLOON HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. PT WAS TAKEN TO OR FOR RIGHT RENAL ARTERY EXPLORATION THROUGH THE RIGHT SUBCOSTAL INCISION WITH REMOVAL OF RETAINED PIECE OF BALLOON, RIGHT RENAL THROMBECTOMY AND HEPATORENAL BYPASS WITH REVERSE SAPHENOUS VEIN GRAFT.
DEVICE WAS REMOVED FROM THE PT DUE TO A COLLAPSED PUMP. A MALLEABLE DEVICE WAS IMPLANTED.
REPORTER STATED, REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE 7MM TIBIAL INSERT. DURING THIS SURGERY, THE REPLACEMENT INSERT WOULD NOT SEAT PROPERLY IN THE BASEPLATE. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
EVAL OF THIS TIBIAL INSERT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT CODE WAS NOT PROVIDED. ATTEMPTS TO OBTAIN THE DEVICE AND/OR DEVICE INFO HAVE BEEN UNSUCCESSFUL.
DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE. THE STAPLES DID NOT LOCK PROPERLY. THE SURGEON APPLIED SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/22/96-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
ON 10/8/96, THE MFR RECEIVED MEDWATCH REPORT VIA THE FDA FOR THE FACILITY. THE REPORT STATES THAT ON 9/12/96, THE DEVICE WAS DISCOVERED TO HAVE ERODED. IT ADDITONALLY STATES THAT THE DEVICE IS UNVAILABALE FOR EVAL.
FURTHER COMMUNICATION WITH THE FACILITY RISK MANAGER, ON 10/29/96, REVEALED THAT SINCE THE DEVICE WAS NOT IMPLANTED AT THIS FACILITY, VERY LITTLE INFO IS AVAILABLE ON THIS EVENT. THE DEVICE WAS BELIEVED TO HAVE BEEN REMOVED AS A RESULT OF AN INFECTION. IT WAS ADDITIONALLY STATED THAT THE DEVICE WAS BELIEVED TO HAVE ERODED THROUGH THE PT'S SKIN. THE FACILITY RISK MANAGER WAS EXPECTED TO CONTACT THE MFR WITH ADDITIONAL INFO, HOWEVER, CO'S ATTEMPTS HAVE BEEN UNSUCCESSFUL. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOT CLOSING THE FILE ON THIS EVENT.
PER THE INFO PROVIDED TO CO BY MEANS OF THE PT'S REP, THE DEVICE WAS REMOVED DUE TO AN "PAIN AND OPERATIONAL PROBLEMS WITH THE DEVICE".
ACCORDING TO THE RECEIVED INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 6/10/1994. ON 9/5/1996 A RECEIVED COMPLAINT FROM A PT REP STATED, "THE PT HAS SUFFERED FROM PAIN AND OPERATIONAL PROBLEMS WITH THE DEVICE. IT WAS REMOVED IN 2/1996." THE PT REP HAS NOT PROVIDED A MEANS OR RELEASE TO CONTINUE WITH THIS INVESTIGATION. TO DATE, THIS COMPLAINT HAS NOT BEEN REPORTED BY A MEDICAL PROFESSIONAL OR CONFIRMED BY THE MFR. WITHOUT INFO FROM A MEDICAL PROFESSIONAL OR AN EXPLANTED DEVICE, QUALITY ASSURANCE IS PRECLUDED FROM COMMENTING ON THIS OCCURRENCE. SHOULD ADDITIONAL INFO AND/OR THE EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND RE-EVALUATED, ACCORDING TO PROCEDURES.
CASSETTE WOULD NOT STAY IN SYSTEM. DEFECT WAS DISCOVERED DURING SETUP PRIOR TO SURGERY.
EVALUATION SUMMARY FROM H.3. CASSETTE WAS TESTED IN A SYSTEM AND DEFECT COULD NOT BE CONFIRMED.
X-TUBE ASSEMBLY 19" X  16". DEALER CLAIMS X-TUBE BROKE AT THE CTR BOLT.
THE DEVICE WAS USED DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE. THE STAPLES DID NOT LOCK PROPERLY. THE SURGEON APPLIED SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/22/96-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. THE PRODUCT WAS NOT RETURNED TO THE MFR FOR EVALUATION.
DEVICE WAS REMOVED FROM THE PT, REASON AND DR. NOT INDICATED. ANOTHER DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO. LOT/SER# 4656P 005.
REPORTER STATED, THE DEVICE BROKE IN SITU AND WAS REVISED.
SUMMARY OF EVALUATION: THE PROXIMAL TIBIAL COMPONENT CANNOT BE EVALUATED FOR THE REPORTED BREAKAGE AS IT HAS NOT BEEN RETURNED TO HOWMEDICA. THE LOT CODE HAS NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE AND LOT CODE INFO HAVE NOT BEEN MADE AS THE USER FACILITY INFO IS NOT AVAILABLE.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE BELOW WELD ON RIGHT SEAT RAIL BAR.
CASSETE WOULD STAY IN SYSTEM. DEFECT WAS DISCOVERED DURING PREPARATION FOR SURGERY.
EVALUATION SUMMARY FROM H.3. CASSETE WAS TESTED IN A SYSTEM AND DEFECT COULD NOT BE CONFIRMED.
WHILE PTA OF RIGHT RENAL ARTERY WAS BEING PERFORMED THE STENT WAS PLACED AND A SYMMETRY BALLOON WAS DEPLOYED. THE BALLOON GOT STUCK IN THE STENT, DID NOT UNWRAP CORRECTLY AND SUBSEQUENTLY BROKE. MULTIPLE ATTEMPTS WERE MADE WITH THE SNARE TO RETRIEVE THE BALLOON HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. PT WAS TAKEN TO OR FOR RIGHT RENAL ARTERY EXPLORATION THROUGH THE RIGHT SUBCOSTAL INCISION WITH REMOVAL OF RETAINED PIECE OF BALLOON, RIGHT RENAL THROMBECTOMY AND HEPATORENAL BYPASS WITH REVERSE SAPHENOUS VEIN GRAFT.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO ANEURYSM OF ONE CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIMS X-TUBE BROKE AT TOP WHERE SEAT RAIL FITS INTO.
THE TUBE ARM DROPPED TO THE FLOOR AND CONTACTED THE OPERATOR ON THE ARM. THE OPERATOR INDICATED SHE HAD SORENESS IN THE ARM FOLLOWING THE EVENT. EVIDENTLY THE SUPPORT CABLES FAILED AND THE EMERGENCY CATCH DID NOT ENGAGE.
REPORTER STATED, THE PT EXPERIENCED PAIN. RADIOGRAPHS REVEALED LOOSENING OF THE TIBIAL BASEPLATE. THE ENTIRE TIBIAL COMPONENT WAS REVISED.
SUMMARY OF EVALUATION: AS RECEIVED, THE TIBIAL INSERT EXHIBITS WERE-THROUGH OF THE MEDIAL-ANTERIOR QUADRANT AND MODERATE WEAR CENTRALLY LOCATED ON THE LATERAL CONDYLE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR. THE INFORMATION PROVIDED AND THE EXAMINATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALIGNMENT AND DEVICE LOOSENING.
CHOLANGIOGRAM HOLDER WAS BEING INSERTED INTO ABDOMEN WITH CATHETER ENTERING CYSTIC DUCT. WHEN HOLDER WAS WITHDRAWN, IT WAS NOTED TIP HAD BROKEN OFF.
PER THE INFO PROVIDED TO CO BY MEANS OF THE PT'S REP, THE DEVICE WAS REMOVED DUE TO AN "INFECTION AND EROSION".
TO DATE, THIS COMPLAINT HAS NOT BEEN REPORTED BY A MED PROFESSIONAL OR CONFIRMED BY THE MFR. WITHOUT INFO FROM A MED PROFESSIONAL OR AN EXPLANTED DEVICE, QA IS PRECLUDED FROM COMMENTING ON THIS OCCURRENCE. THE MFR IS ALSO UNABLE TO SHOW THAT THE DEVICE IN QUESTION WAS MFR BY THIS CORP. SHOULD ADD'L INFO AND/OR THE EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE REOPENED AND RE-EVALUATED, ACCORDING TO PROCEDURES.
CASSETTE WOULD NOT STAY IN MICROSURGICAL SYSTEM. DEFECT WAS DISCOVERED DURING PREPARATION FOR SURGERY.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION." ACC'L LOT/SER# 1333Q 012.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. TUBING HAD OR DAMAGE. TUBING WAS FUNCTIONAL.
THE GEAR BOX DRIVE SHAFT FAILED ALLOWING THE C-ARM TO ROTATE FREELY. THE UNIT HAS BEEN REPAIRED AND PLACED BACK INTO SVC. NO INJURY WAS REPORTED.
TIP OF SUTURE NEEDLE BROKE OFF DURING WOUND SUTURING. ABLE TO RETRIEVE TIP WITHOUT COMPLICATION OR HARM TO PT. EXPIRATION DATE 5/2001.
REPORTER STATED, REVISION SURGERY REVEALED THE PATELLAR COMPONENT WAS NOT PROPERLY TRACKING. THE PATELLA WAS REMOVED.
SUMMARY OF EVALUATION: THE PATELLAR COMPONENT CAN NOT BE EVALUATED FOR THE REPORTED TRACKING PROBLEM AS IT HAS NOT BEEN RETURNED TO CO. THE LOT CODE HAS NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORD FOR THE COMPONENT IS NOT POSSIBLE. ATTEMPTS TO OBTAIN LOT CODE INFORMATION HAVE BEEN UNSUCCESSFUL.
THIS BALLOON CATHETER WAS USED TO DEPLOY A STENT. RESISTANCE UPON BALLOON CATHETER WITHDRAWAL POST STENT DEPLOYMENT WAS ENCOUNTERED. CONTINUAL EXERTION AND MANIPULATION AGAINST THIS RESISTANCE RESULTED IN REMOVAL OF THE CATHETER SHAFT, HOWEVER, THE BALLOON MATERIAL AND ONE RADIOPAQUE MARKER REMAINED IN THE PT AND WERE BELIEVED TO BE HUNG UP ON THE STENT. A RENAL ARTERY BYPASS PROCEDURE FOLLOWED. IT WAS BELIEVED THE BALLOON MATERIAL AND MARKER WERE REMOVED AT THAT TIME. THE PT EXPIRED ONE DAY POST SURGERY. THE CAUSE OF DEATH WAS UNK, HOWEVER, A MYOCARDIAL INFARCTION WAS SUSPECTED. AS PER USER FACILITY MEDWATCH REPORT, THE PT HAS A HISTORY OF THREE MI'S, DM, ASHD AND RENAL HYPERTENSION. THE PT'S RISK FACTORS AS WELL AS USE OF THIS DEVICE IN A NON-INDICATED PROCEDURE MAY HAVE BEEN CONTRIBUTING. THIS DEVICE WAS DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. CO'S DIRECTIONS FOR USE STATE: CO'S BALLOON DILATATION CATHETERS ARE RECOMMENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF SMALL, NARROWED OR OBSTRUCTED ILIAC, FEMORAL OR RENAL VESSELS IN THE PERIPHERAL VASCULATURE."
THE INFO SUPPLIED IN SECTION F ON THIS MEDWATCH REPORT HAS BEEN PROVIDED BY THE MFR. SEE USER FACILITY REPORT.
REPORTER STATED, REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA. THE TIBIAL BASEPLATE ALSO SETTLED INTO VARUS AND WAS REMOVED. THE FEMORAL COMPONENT WAS ALSO REVISED AT THIS TIME TO A COMPATIBLE REVISION COMPONENT.
THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AND LOSS OF FIXATION OF THE TIBIAL COMPONENT AS THEY HAVE NOT BEEN RETURNED TO CO BUT RATHER HAVE BEEN DISCARDED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH COMPONENTS FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MFR.
REMOVAL OF BREAST IMPLANTS DUE TO CHANGES IN SURROUNDING TISSUE.
CAME APART AND LEAKING WHERE REINFUSING.
INVESTIGATION CONDUCTED. DR CITES POOR ORAL HYGIENE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED INPLANTS - (FROM BOX D6). MODEL/CATALOG # 2212/2212. LOT NUMBER UNKNOWN.
CUSTOMER REPORTED THEY FELT THE OUTPUT OF THE VAPORIZER WAS HIGHER THAN EXPECTED. THERE WAS NO REPORTED PT INJURY. CO'S INVESTIGATION INTO THE REPORTED EVENT IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
INVESTIGATION/CONCLUSION: THE UNIT WAS RETURNED TO THE MFG SITE FOR INVESTIGATION. THE UNIT WAS TESTED AND THE REPORTED COMPLAINT WAS CONFIRMED. THE INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THE REPORTED COMPLAINT WAS DUE TO SCRATCHING AND/OR FLATNESS ISSUES RELATED TO THE SEALING FACE OF THE ROTARY VALVE. CHANGES IN MFG PROCESSES HAVE GREATLY REDUCED THESE ISSUES. CHANGES WERE IMPLEMENTED INTO THE MFG, REFURBISHING AND SVC PROCESSES IN 6/97.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE THE PROSTHESIS WOULD NOT DEFLATE. ADD'L LOT/SER# 1313L 014.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. TUBING HAD OR DAMAGE.
REVISION SURGERY REVEALED LOOSENING OF THE TOTAL KNEE COMPONENTS.
THE TOTAL KNEE COMPONENTS CAN BE EVALUATED FOR THE REPORTED LOOSENING AS THEY HAVE NOT BEEN RETURNED TO CO. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS THE CATALOG NUMBERS AND LOT CODES HAVE NOT BEEN SUPPLIED. ATTEMPTS TO OBTAIN THE DEVICE, CATALOG NUMBER, AND LOT CODE HAVE BEEN UNSUCCESSFUL.
THE DEVICE HAS AN INTERMITTENT LOSS OF ATRIAL SENSING.
X-TUBE 16" X 17". DEALER ALLEGES X-TUBE BROKE WHILE IN USE. BROKE NEAR CENTER OF TUBE.
DURING A GASTRECTOMY PROCEDURE, THE CLIPS WERE NOT LOADING PROPERLY. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
CUSTOMER REPORTED THEY FELT THE OUTPUT OF THE VAPORIZER WAS HIGHER THAN EXPECTED. THERE WAS NO REPORTED PT INJURY. CO'S INVESTIGATION INTO THE REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
IT WAS ALSO FOUND DURING THE INVESTIGATION THAT THE VAPORIZER'S SUMP THERMAL FUSE HAD FAILED. THE TEMPERATURE RATING OF THE SUMP THERMAL FUS IS TOO LOW, CAUSING PREMATURE AGING AND FAILURE FROM EXPECTED STORAGE AND WORKING TEMPERATURES. THE FUSE HAS SINCE BEEN REVISED TO A HIGHER TEMPERATURE RATING, HELPING TO PREVENT PREMATURE AGING AND SUBSEQUENT FAILURE. FAILURE OF THE FUSE CAUSES A 'NO OUTPUT' ALARM. INVESTIGATION/CONCLUSION: THE UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED, THE CAUSE OF WHICH WAS THE ROTARY VALVE. OHMEDA HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE TEC 6 VAPORIZER. AS A RESULT, THE FREQUENCY OF OCCURRENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED U.S. BASE IN FISCAL YEAR 1996 FROM 0.4% IN 1994. OHMEDA WILL CONTINUE TO MONITOR THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER MATERIAL AND/OR PROCESS MODIFICATIONS. IT WAS ALSO FOUND DURING THE INVESTIGATION THAT THE VAPORIZER'S SUMP THERMAL FUSE HAD FAILED. THE TEMPERATURE RATING OF THE SUMP THERMAL FUSE IS TOO LOW, CAUSING PREMATURE AGING AND FAILURE FROM EXPECTED STORAGE AND WORKING TEMPERATURES. THE FUSE HAS SINCE BEEN REVISED TO A HIGHER TEMPERATURE RATING, HELPING TO PREVENT PREMATURE AGING AND SUBSEQUENT FAILURE. FAILURE OF THE FUSE CAUSES A 'NO OUTPUT' ALARM.
DURING EVALUATION AND FUNCTION OF A NEW WHEELCHAIR, STAFF PERSON RECEIVED LACERATIONS TO FOUR FINGERS. ON THE LEFT SIDE OF THE W/C, THE HAND GRIPS WERE COVERED WITH CHROME. AS THE W/C WAS BEING TESTED, THE CHROME CUT THE PERSON'S FINGERS ON THE LEFT HAND.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECSYTECTOMY PROCEDURE. THE CLIPS SLIPPED OFF THE VESSEL. THE SURGEON RELOADED THE INSTRUMENT WITH ANOTHER CARTRIDGE TO COMPLETE THE PROCEDURE. THE HOSP REPORTED THAT NO PT INJURY OCCURRED.
UPON EVALUATION OF THE DEVICE, IT WAS FOUND THAT THE DISPOSABLE LOADING UNIT WAS FULLY FIRED PREVENTING A FUNCTIONAL EVALUATION. THE APPLIER WAS EVALUATED AND FOUND TO HAVE BEEN IMPROPERLY HANDLED AND CLEANED BY THE USER PREVENTING PROPER FUNCTION OF THE UNIT. THIS CONDITION MAY OR MAY NOT BE RELATED TO THE CONDITION REPORTED BY THE USER FACILITY.
TIP OF RESECTOSCOPE INNER SHEATH SEPARATED IN PT AND HAD TO BE RETRIEVED.
DATE OF MANUFACTURE ERROR DETECTED 03/26/1998 DURING EXAMINATION OF FILES.
X-TUBE ASSEMBLY 18" X 16". DEALER ALLEGES X-TUBE BROKE WHILE USER WAS SITTING IN IT. BROKE AT CTR BOLT.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS - CONNECTOR. LOT/SER# 3761M002.
DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AND LOSS OF FIXATION OF THE TIBIAL COMPONENT AS THEY HAVE NOT BEEN RETURNED TO CO BUT RATHER HAVE BEEN DISCARDED BY THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH COMPONENTS FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MFG.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. THE INSTRUMENT MISFIRED. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
PT UNDERWENT AN ANTERIOR CERVICAL FUSION ON 1/16/96. THERE WAS A BREAKAGE OF THE CERVICAL PLATE THROUGH THE INFERIOR CENTER HOLE REQUIRING SURGICAL REPLACEMENT.
THE DR WAS PERFORMING A CEREBRAL ANGIOGRAM. HE ACTIVATED THE SID CONTROL TO MOVE THE IMAGE INTENSIFIER AWAY FROM THE PT. IT RESPONDED BY MOVING IN THE OPPOSITE DIRECTION THAN INTENDED. THE ASSEMBLY CAME INTO CONTACT WITH THE PT'S HEAD. THE PT WAS NOT INJURED.
DEVICE WAS REMOVED FROM THE PT DUE TO SCROTAL EROSION. LOT/SER# 0385K018.
5/13/97-SUPPLEMENTAL REPORT #2 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED IN H3 AND CORRECTED CODES ENTERED IN H6.
TIP SEPARATED FROM RESECTOSCOPE INNER SHEATH AND HAD TO BE RETRIEVED FROM PT'S BLADDER.
INSUFFICIENT INFO TO DETERMINE PRECISE CAUSE OF THE PROBLEM. SOME POSSIBLE CAUSES ARE: A) PRIOR TO LAST PROCEDURE, EXCESSIVE TORQUE APPLIED TO DISTAL TIP SUFFICIENT TO FRACTURE BOND AND SMOOTH SWAGES, AND PERMITTING TIP TO SEPARATE FROM SHEATH TUBE; B) ROUGH HANDLING DURING CLEANING, DISINFECTION, AND/OR STERILIZATION OVER TIME CAUSED TIP TO BE LOOSENED.
THE PRODUCT WAS USED DURING A HERNIA PROCEDURE. THE SUTURE BROKE AS KNOTS WERE BEING TIED. NO PT INJURY REPORTED. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE.
THE SAMPLE WAS RECEIVED AND EVALUATED AND THE BACKFLOW WAS DUPLICATED. THE CHECKVALVE WAS EXAMINED AND PARTICULATE WAS NOTED INSIDE THE VALVE ON THE SEALING SURFACE. IT IS SUSPECTED THAT THE PARTICULATE CAUSED THE REPORTED BACKFLOW. THE MFR OF THE CHECK VALVE HAS BEEN NOTIFIED OF THE ISSUE OF PARTICULATE. CHANGES HAVE BEEN MADE TO THE MANUFACTURING AND ASSEMBLY PROCESS TO REDUCE THE LIKELIHOOD OF PARTICULATE BEING INTRODUCED INTO THE CHECK VALVE DURING MANUFACTURING. THIS REPORT WAS FILLED OUT BY THE MFR. THERE WAS NO PT INFO DOCUMENTED BY THE USER FACILITY. MANUFACTURER'S REPORT DATE 10/30/96.
DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION -PUMP/SCROTUM, AND PT DISSATISFACTION - NEVER WORKED RIGHT. LOT/SER# 1161Q005.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED BY THE REP THAT THE INSTRUMENT DID NOT FIRE OR CUT. THERE WAS NO CONSEQUENCE TO THE PT.
D6: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
DURING A LAPAROSCOPIC SALPINGECTOMY PROCEDURE, THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE TISSUE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
PULSE GENERATION INFECTION/EROSION. REMOVAL OF OLD PACEMAKER GENERATOR AND ATRIAL WIRE. DEVICE REPLACED.
DURING 3RD MOLAR EXTRACTION IT WAS REPORTED THAT THE #16 AND #17 REMOVED. DURING REMOVAL OF #32 THE INSTRUMENT OVERHEATED AND BURNED RIGHT LIP, 1ST DEGREE BURN. CANALOG PRESCRIBED.
INSTRUMENT RECEIVED ON 5/9/97, TESTED PER THE ACCEPTANE CRITERIA. NO PROBLEM WAS FOUND. INSTRUMENT DID NOT OVERHEAT. TEAR DOWN OF THE INSTRUMENT FOUND NOTHING TO CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. POSSIBLE CAUSE FOR OVERHEAT BY USER MAY BE EXCESS RUN TIME WITHOUT COOLING OR NOT HAVING THE BUR FULLY LOCKED IN PLACE. LETTER IS BEING SENT TO THE CUSTOMER FOR REVIEW OF CAUTIONS AND INSTRUCTIONS IN THE USERS MANUAL. THE USER MANUAL OUTLINES MONITORING OF INSTRUMENT FOR OVERHEAT DURING USE AND COOLING INSTRUCTIONS.
THE PRODUCT WAS USED DURING A HERNIA REPAIR PROCEDURE. THE NEEDLE BROKE WHILE PASING THROUGH TISSUE. NO PT INJURY REPORTED. THE SURGEON ANOTHER SUTURE TO COMPLETE THE PROCEDURE.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS - CYLINDERS.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAS OR DAMAGE. CYLINDER WAS NOT FUNCTIONALLY TESTED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC BILATERAL HERNIA REPAIR. IT WAS REPORTED BY THE REP THAT AFTER THE 3RD STAPLE THE INSTRUMENT DID NOT WORK ANYMORE. THE STAPLE GOT STUCK. THE INSTRUMENT ONLY HAD TWO STAPLES. THERE WAS NO CONSEQUENCE TO THE PT.
H6; (2) UNFOMRED STAPLES JAMMED IN THE CARTRIDGE NOSE AND WITH YIELDED CARTRIDGE NOSE WELD. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT'S "STAPLE GOT STUCK" DURING SURGERY MAY HAVE BEEN DUE TO A YIELDED CARTRIDGE NOSE WELD AND 2 UNFORMED STAPLES IN THE CARTRIDGE NOSE WHICH CAUSED THE INSTRUMENT TO JAM. THE INSTRUMENT WAS RECEIVED WITH 2 UNFORMED STAPLES JAMMED IN THE CARTRIDGE NOSE AND WITH A YIELDED CARTRIDGE NOSE WELD. THE 2 UNFORMED STAPLES WERE REMOVED FROM THE CARTRIDGE NOSE AND THE INSTRUMENT THEN CYLCED AND FIRED THE REMAINING 8 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO IF THE YIELDED CARTRIDGE NOSE WELD HAD CAUSED THE STAPLES TO JAM IN THE NOSE OR IF THE JAMMED STAPLES HAD CAUSED THE CARTRIDGE NOSE WELD TO YIELD. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. THE FEEDING OF MULTIPLE STAPLES INTO THE NOSE MAY OCCUR IF THE FIRING CYLCE STROKE IS NOT COMPLETED AND THE INSTRUMENT IS REFIRED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
AIR WAS NOTED IN THE LINE BELOW THE PUMP. THERE WAS NO PT COMPLICATION.
THE SAMPLE SET WAS DISCARDED AT THE USER FACILITY THEREFORE NO EVALUATION COULD BE PERFORMED. THIS REPORT WAS FILLED OUT BY THE MFR. PT INFO WAS NOT AVAILABLE FROM THE USER FACILITY. MFR'S REPORT DATE 10/30/96.
DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED BY REP BROKEN TRIGGER. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION BASED UPON IFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT WAS RETURNED NON-FUNCTIONAL. INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
JAW SEPARATED FROM FORCEPS IN PT'S BLADDER; WAS RETRIEVED.
THE DEVICE WAS USED DURING AN UNSPECIFIED RESECTION PROCEDURE. THE12199301996INSTRUMENT MISFIRED. NO PT INJURY OCCURRED. THE HOSP DID NOT PROVIDE ANY FURTHER INFO.
11/4/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
REPORTER STATED, REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA AND LOOSENING OF THE TIBIAL BASEPALTE.
SUMMARY OF EVALUATION: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AND LOSS OF FIXATION AS THEY HAVE NOT BEEN RETURNED TO CO BUT RATHER HAVE BEEN DISCARDED BY THE HOSPITAL. ATTEMPTS TO OBTAIN LOT CODE INFORMATION HAVE BEEN UNSUCCESSFUL.
DEVICE WAS REMOVED FROM THE PT DUE TO PAIN AND BLEEDING.
DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED BY THE REP THAT THE STAPLES WOULD NOT ADVANCE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFO NOT SUPPLIED BY AFFILIATE. D5,6;H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR EVAL.
REPORT OF ALLEGED "STOP CYCLE WHILE ON PT, UNSURE IF UNIT ALARMED. NO PT HARM. WHEN BENCH TESTED, UNIT MAKES A LOUD GRINDING NOISE AND AFTER 5 MINUTES UNIT SHUTS DOWN AND ALARMS SETTING ERROR".
100-REPORTED FAILURE DUE TO ROTOR BEING OUT OF SPECIFICATION. REPLACED ROTOR. TESTING BY MFR FOUND A SETTING ERROR, MOTOR STALLED, WITH AUDIBLE LOW PRESSURE ALARM, DUE TO ROTOR BEING OUT OF SPECIFICATION. REPLACED ROTOR.
VISITOR IN PT ROOM LEANED AGAINST BIO HAZARD NEEDLE RECEPTACLE. RT HAND RECEIVED PUNCTURE FROM NEEDLE PROTRUDING FROM NEEDLE BOX.
THE INSTRUMENT WAS USED AN UNSPECIFIED PROCEDURE. THE DEVICE WAS DIFFICULT TO OPEN. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PUMP EROSION AND INFECTION.
CYLINDER HAD OR DAMAGE. CYLINDER HAD OR DAMAGE. PUMP PERFORMED WITHIN SPECS.
TWO DAYS AFTER SURGERY, PT NOTIFIED DOCTOR. THAT BURR HAD OCCURRED DURING 3RD MOLAR EXTRACTION ON 9/23/96. NO ADD'L MEDICATION OR TREATMENT WAS PRESCRIBED.
INSTRUMENT RECEIVED ON 5/9/97, TESTED PER THE ACCEPTANCE CRITERIA. NO PROBLEM WAS FOUND. INSTRUMENT DID NOT OVERHEAT. TEAR DOWN OF THE INSTRUMENT FOUND NOTHING TO CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. POSSIBLE CAUSE FOR OVERHEAT BY USER MAY BE EXCESS RUN TIME WITHOUT COOLING OR NOT HAVING THE BUR FULLY LOCKED IN PLACE. LETTER IS BEING SENT TO THE CUSTOMER FOR REVIEW OF CAUTIONS AND INSTRUCTIONS IN THE USER MANUAL. THE USER MANUAL OUTLINES MONITORING OF INSTRUMENT FOR OVERHEAT DURING USE AND COOLIG INSTRUCTIONS.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED UPON INFLATION OF THE BALLOON IN THE PT, THE BALLOON BURST. APPROX 25 PUMPS WERE MADE TO INFLATE THE BALLOON AND IT WAS TESTED PRIOR TO INSERTION. THE OTOMY CREATED WAS APPROX 19MM AND METAL S-RETRACTORS WERE USED. A SECOND INSTRUMENT WAS USED WITHOUT DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT.
10/10/96 1201 MESSAGE AND 800# LEFT FOR MD CALL BACK. HE WILL BE BACK IN THE OFFICE FRIDAY AFTERNOON. 10/11/96 1500 NNCL SENT. A1,2,3,4; B6,7; D5, 10; H4: INFO UNAVAILABLE. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE BVALLOON HAD BURST NEAR THE DISTAL TIP. MAKING THE INSTRUMENT NON FUNCTIONAL. THE INSTRUMENT WAS RECEIVED WITH A BALLOON WHICH HAD BURST. THE BALLOON WAS OBSERVED TO BE IN ONE PIECE. THE POINT OF PROPAGATION WAS APPROX 150 DEGREES FROM THE STOPCOCK POSITION JUST BELOW THE DISTAL EXTENSION RING. THERE WERE NO ABRASION MARKS OBSERVED AT THE POINT OF DAMAGE AND THERE WERE NO DEFORMATIONS TO THE DISTAL EXTENSION RING OR THE EXTENSION LEGS. NO CONCLUSION COULD BE REACHED AS TO WHY THE BALLOON HAD BURST DURING SURGERY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY.
THE DEVICE WAS USED DURING A FEMORAL POP PROCEDURE. THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE.
2/14/97-SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE IT DOES NOT INFLATE.
APPROX. 5-10 MINUTES INTO A DIALYSIS TREATMENT, THERE WAS A BLOOD LEAK WITH NO ALARM CONDITION. BLOOD LOSS WAS ESTIMATED AT 150-200CC. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
A REVIEW OF THE DTF HISTORY DOES NOT INDICATE THAT THIS OR A RELATED CONDITION WAS PRESENT AT THE TIME OF MANUFACTURING. A REVIEW OF THE CPF HISTORY DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THE LOT WAS RELEASED TO THE FIELD. A SECONDARY DTF SEARCH OF THE RAW MATERIAL PRODUCTION LOT OF THE BLD DID NOT REVEAL ANY REPORTED DEFECTS. A SECONDARY DTF SEARCH OF THE RAW MATERIAL PRODUCTION LOT OF THE UF CCA DID NOT REVEAL ANY DEFECTS RELATED TO THIS CCA. THE RETURNED BLOOD LEAK DETECTOR AND UF CCA WAS VISUALLY INSPECTED AND NO VISUAL DEFECTS WERE FOUND. THE BLD AND UF CCA WAS PLACED INTO CALIBRATED CS3 MACHINE AND TESTED PER THE PROCEDURE 341555000 AND PASSED. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. IT IS POSSIBLE THAT THE BLD DID NOT ALARM BECAUSE THE MACHINE MAY HAVE BEEN IN BY-PASS DUE TO THE PH ALARM; THEREFORE, DIALYSATE MAY NOT HAVE BEEN FLOWING PAST THE BLD. THE UF CCA WAS ONLY TESTED PER THE BLD TEST BECAUSE THE CCA WAS REPLACED WITH THE BLOOD LEAK DETECTOR AND NO OTHER DEFECTS WERE REPORTED ON THE CCA. THE ABOVE TESTING INDICATES THAT THIS BLOOD LEAK DETECTOR MET MANUFACTURING SPECIFICATIONS. THE MFR IS CONTINUING TO MONITOR AND TRENT. NO FURTHER REPORTING IS ANTICIPATED AT THIS TIME. SEE FAR # 960012. CUSTOMER CONTACTED:Y. SALES/SERVICE CONTACTED BY INVESTIGATOR:N TRAINING REQUIRED:N.
DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED BY THE REP THE INSTRUMENT WAS SHORT COUNT/EMPTY AND JAMMED/DIFFICULT TO USE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; D3,6,7; D10: INFO NOT PROVIDED BY AFFILIATE. D5,6; H4: INFO UNAVAILABLE, DEVICE NOT RETURNE FOR EVAL.
PROBLEMS LIKELY CAUSED BY ARC BETWEEN CUTTING LOOP PROXIMAL END AND DAMAGED CONTACT SPRING. RF CURRENT PARTIALLY RECTIFIED BY ARC INTO A LOWER FREQUENCY CURRENT AND CONDUCTED THROUGH CUTTING LOOP TO PT. CONTACT PROBABLY DAMAGED BY CUTTING LOOP NOT FULLY INSERTED. DAMAGE MAY HAVE BEEN EXACEBATED BY REUSING CUTTING LOOPS.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO "MALFUNCTION".
DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED BY THE REP THAT THE STAPLES WERE NOT ADVANCING. THERE WAS NO CONSEQUENCE TO THE PT.
A2,3,4; B3,6,7; D5,6,10;H4; INFO NOT PROVIDED BY AFFILIATE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO A NON-FUNCTIONING DEVICE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE JAWS SCISSORED AND DAMAGED THE CYSTIC DUCT. THE SURGEON USED ANOTHER CLIP TO COMPLETE THE PROCEDURE.
A USER MEDWATCH REPORT WAS REC'D BY CO ON 10/21/96. THE REPORT INDICATED WHEN ATTEMPTING TO GO ON BYPASS, THE VENOUS LINE WAS CONNECTED AND RETURN FLOW WAS OBTAINED. ARTERIAL LINE WAS CONNECTED AND DID NOT FLOW. THE FILTER WAS CLAMPED OFF AND THE BYPASS LINE WAS OPENED AND FLOW TO THE PT WAS STARTED. THE CASE PROCEEDED AND COMPLETED WITH NO PT PROBLEMS REPORTED. THE CO ARTERIAL (20 MICRON) FILTER WAS A COMPONENT OF ANOTHER CO'S TUBING PACK MODEL NO. 8139-D, LOT NO. 145609.
THE BLOOD FILTER WAS A COMPINENT OF ANOTHER CO'S BIOMEDICAL TUBING PACK MODEL NO. 8139-D, LOT NO. 145609. THE CO'S ARTERIAL BLOOD FILTER WAS REC'D BY THE OTHER CO FOR COMPLAINT EVAL ON 10/24/96. THE FILTER WAS PRIMED WITH WATER AND TESTED WITH A CONTINUOUS FLOW RATE UNDER THE OBSERVATION OF CO'S TECHNICAL STAFF. THE WATER FLOWED FREELY THROUGH THE FILTER IN QUESTION WITH NO ANOMALIES NOTED. VISUAL EXAMINATION NOTED NO PHYSICAL DAMAGE TO THE FILTER. THE FILTER WAS THEN FORWARDED TO CO'S RESEARCH AND DEVELOPMENT LABORATORY FOR FURTHER TESTING WITH BOVINE BLOOD. THE FILTER WAS PRIMED AND TESTED FOR PRESSURE DROP AT 1,2, AND 3 LPM. FLOW THROUGH THE FILTER APPEARED NORMAL AT EACH FLOW RATE. IN SUMMARY, THE BLOOD FILTER APPEARED TO BE NORMAL WITH NO ANOMALIES NOTED DURING THE EVAL. THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIV BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIV. ITS OFFICERS, EMPLOYEES, OR AGENTS.
SIXTY THREE (63) YEAR OLD PT CAME TO ED DUE TO ABDOMINAL PAIN, PLACED ON STRETCHER AND SIDE RAIL PLACED UP. PT HAD TO VOMIT AND LEANED OVER RAIL, WHICH COLLAPSED. PT FELL ON FLOOR AND FRACTURED HER WRIST. SPLINT APPLIED. EVENT HAPPENED DUE TO FALSE LATCH CONDITION BENT FRAME. ADDED WASHER BETWEEN HEAD LATCH SHIP AND CROSS-FRAME BAR CAUSED SOONER LATCH OCCURRENCE BEFORE GASSPRING EXTENSION LIMIT REACHED. RAIL NOT CHECKED TO MAKE SURE IT WAS SECURE.
DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED BY THE REP THE INSTRUMENT DID NOT FIRE. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT FIRE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. THIS INQUIRY WAS ORIGINALLY REPORTED AS AN RPO "RECORD PURPOSE ONLY." COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
THE INSTRUMENT WAS USED DURING A LAPAROSOCPIC VAGINAL HYSTERECTOMY. THE DEVICE WAS PLACED THROUGH THE SEAL CAP ON BOTH SIDES OF THE PT AND BOTH 1 SEALS MADE A POPPING SOUND. UPON REMOVAL OF THE DEVICE, THE SEALS WERE NOTED TO BE TORN AND LEAKING. THE DEVICE LOCKED OUT AFTER THE THIRD FIRNG. THE CARTRIDGE WAS REPLACED AND INSTRUMENT REMAINED LOCKED OUT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSQEUENCE TO THE PT.
10/10/96 1203 MESSAGE AND 800# LEFT FOR MD CALL BACK. HE WILL BE IN THE OFFICE FRIDAY. 10/11/96 1055 DR CONFIRMED THE INFO EXACTLY AS REPORTED BY THE SALES REP. HE STATED THE 1SEALS LIKELY TORE AT THE BEGINNING OF THE CASE WHILE USING THE DEVICE'S, BUT IT DID NOT BECOME A HUGE DIFFICULTY UNTIL HE WENT TO USE THE 5MM HANDHELD INSTRUMENTS AND THE LEAKING WAS EXTENSIVE. THE DEVICE FIRED WITHOUT DIFFICULTY FOR THREE FIRINGS, THEN DID NOT FIRE ON THE NEXT 2 RELOADS. A NEW INSTRUMENT WAS OPENED TO COMPLETE THE CASE. A1,2,4; B6,7; D10; H4; INFO UNAVAILABLE. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "LOCKED OUT" DURING SURGERY. THE INSTRUMENT WAS RETURNED WITH A BENT KNIFE, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. THE RETURNED CARTRIDGE WAS MISSING THE MIDDLE ALIGNMENT FINGER AN THE LOCKOUT TAB. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
THE PRODUCT WAS USED DURING AN INFUSION PORT INSERTION. REPORTEDLY, THE CATHETER WAS BLOCKED. THE SURGEON REMOVED THE CATHETER AND IMPLANTED ANOTHER ONE DURING THE ORIGINAL PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/31/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
AN AUS DEVICE WAS IMPLANTED ON 7/26/93. THE BALLOON AND PUMP WERE REMOVED ON 9/13/93. ON 10/2/96 THE CUFF WAS REMOVED FROM THE PT DUE TO INFECTION. AN ENTIRE AUS DEVICE WAS IMPLANTED.
DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED BY THE REP THAT THE INSTRUMENT WAS DIFFICULT TO USE AND WOULD NOT FIRE OR CUT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B3,6,7; D5,6,10; H4; INFO NOT PROVIDED BY AFFILIATE.
FORTY (40) YEAR OLD PT WITH INTERNAL DERANGEMENT WAS HAVING AN ARTHROSCOPY DONE WHEN THE HAND PIECE OF THE LASER AT THE CONNECTION MELTED. IT WAS REPLACED BY THE 60 DEGREE PROBE AND CASE CONTINUED. PHYSICIAN PREFERRED THE SIDE FIRE PROBE. IT IS NOT KNOWN AT THIS TIME WHAT ADVERSE OUTCOME PT MAY HAVE. THE PHYSICIAN STATES IT WILL BE APPROXIMATELY SIX (6) MONTHS BEFORE THIS IS KNOWN.
DURING A CATARACT EXTRACTION PROCEDURE, THIS OPHTHALMIC MICROSURGICAL UNIT EXHIBITED INTERMITTENT PHACO POWER. ANOTHER UNIT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
SECTION A THROUGH F WERE COMPLETED BY THE MANURACTURER. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
INFO RECEIVED ON 1/9/97 INDICATES THE AUS DEVICE WAS REMOVED FROM THE PT ON 2/7/96 DUE TO ATROPHY.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE JAWS WERE DIFFICULT TO OPEN. THE SURGEON MANIPULATED THE INSTRUMENT OF THE TISSUE WITHOUT INCIDENT.
10/31/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. CO FOREIGN SUBSIDIARY WAS INFORMED OF THIS EVENT ON 9/24/96. HOWEVER, CORPORATE WAS NOT INFORMED UNTIL 10/29/96. CO FOREIGN SUBSIDIARY WILL BE RE-INSTRUCTED REGARDING THE STATUTORY REPORTING REQUIREMENTS OF THE MDR REGULATION.
REPORT OF ALLEGED "SINGLE TONE ALARM, ALL LEDS ON, UNIT DOESN'T CYCLE. NOT IN PT USE".
TESTING BY MFR FOUND DEVICE WOULD NOT CYCLE, WITH ALL LEDS AND CONSTANT SINGLE TONE ALARM, DUE TO INTEGRATED CIRCUIT U28 ON THE LOGIC BOARD BEING OUT OF SPECIFICATION. REPLACED U28.
AFTER 86.5 HRS OF USE THE PUMP ALARM WITH HIGH PRESSURE 2X AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED AND REPLACED. PT IS FINE.
H-11-ALL UNKNOWN INFO REQUESTED BUT NOT RECEIVED. H-11 SECTION F PROVIDED BY MFR. H-11-SECTION F10 DEVICE CODE 1746 LABELED.
THE TRACHESOTOMY TUBE CUFF LEAKED AIR AND COULD NOT MAINTAIN INFLATION. THE DEVICE WAS PLACED FOLLOWING A TRACHEOTOMY PROCEDURE. TWO DAYS POST-OP, SECRETIONS WERE OBSERVED ENTERING THE TRACHEA. THE CUFF WAS REINFLATED AND A LEAK IN THE INFLATION SYSTEM WAS DISCOVERED. THE HOSP STAFF RESOLVED THE PROBLEM BY PUTTING A GATE CLAMP ON THE INFLATION LINE. THE PT HAD A CHEST INFECTION WHICH WAS TREATED WITH ANTIBIOTICS. THE HOSP STAFF FELT THE DEVICE MALFUNCTION CONTRIBUTED TO THE PT'S CONDITION.
EVALUATION OF THE RETURNED PRODUCT CONFIRMED A MINUTE AIR LEAK FROM THE PROXIMAL END OF THE CUFF. REVIEW OF THE DEVICE HISTORY RECORDS INDICATED ALL PRODUCT WAS 100% INSPECTED FOR INFLATION SYSTEM INTEGRITY AND CONFIRMED TO BE ACCEPTABLE PRIOR TO RELEASE. IT SHOULD BE NOTED THAT THE COMPLAINT REPORT INDICATED THE DEVICE WAS NOT TESTED PRIOR TO USE. THE DEVICE WAS PLACED DURING A TRACHEOSTOMY PROCEDURE.
ON 5/10/96 AN AUS DEVICE WAS IMPLANTED. IN AUG. OF 1996, DAY NOT INDICATED, THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION.
DURING AN UNKNOWN PROCEDURE, THE INSTRUMENT WOULD NOT FIRE OR CUT. THERE WAS NO CONSEQUENCE TO THE PT.
AS PT WAS TRANSFERRED TO THE WHEELCHAIR, THE PT'S LEG WAS CUT ON THE PART OF THE WHEELCHAIR THAT IS USED TO ATTACH THE FOOTREST. THE CUT REQUIRED STITCHES.
THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER HANDPICE WAS USED.
SECTION A THROUGH F WERE COMPLETED BY THE MANUFACTURER. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED.
THE SUTURE WAS USED DURING A GASTRECTOMY PROCEDURE. REPORTEDLY, THE KNOTS WERE LOOSE. THE SURGEON RE-SUTURED.
10/31/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DUE TO CLERICAL ERROR, THE STATUTORY REPORTING REQUIRMENT OF 30 CALENDAR DAYS TO REPORT WAS EXCEEDED.
AS PT WAS TRANSFERRED FROM THE BED TO THE WHEELCHAIR THE PT'S LEG WAS CUT ON THE PART OF THE WHEELCHAIR THAT IS USED FOR FOOTREST. THE CUT REQUIRED STITCHES.
PRODUCT IS A RECHARGEABLE ELECTRIC SONIC TOOTHBRUSH. THE PRODUCT PROBLEM IS THE ABSENCE OF EPOXY POTTING COMPOUND IN THE CHARGER BASE. THE COMPOUND PROVIDES ELECTRICAL INSULATION AND HOLDS THE CHARGER PARTS TOGETHER. IN ITS ABSENCE, THERE IS A POTENTIAL FOR TH EPRODUCT USER TO RECEIVE AN ELECTRIC SHOCK OR EVEN ELECTROCUTION FROM CONTACT WITH UNINSULATED HOUSEHOLD CURRENT.
THE AFFECTED UNIT WAS MANUFACTURED IN THE PERIOD FROM 9/3/96 TO 10/30/96. CO HAS VOLUNTARILY INITIATED AN IMMEDIATE RECALL TO REPLACE THE CHARGER BASES ON UNITS MANUFACTURED DURING THIS TIME PERIOD. THIS RECALL IS BEING DIRECTED AT HEALTH CARE PROFESSIONAL, WHOLESALERS, RETAILERS AND CONSUMERS. CO HAS INITIATED MFG AND PACKAGING PROCESS CHANGES AND INSPECTIONS TO PREVENT RECURRENCE OF THIS PROBLEM.
THIS DIAMOND KNIFE WAS SELDOM USED BECAUSE THE ADJUSTMENT OF 0.3 WAS INCORRECT. THE PROBLEM WAS FOUND DURING AN OPHTHALMIC PROCEDURE.
DIAMOND BLADE FOUND TO BE BROKEN. CUSTOMER CHARGED FOR REPAIR.
REPORT OF ALLEGED "UNIT WILL NOT RUN ON AC OR DC POWER, NO ALARMS, NOT CYCLING. THIS OCCURRED AFTER CUSTOMER EXPERIENCED A POWER SURGE. NO PT HARM".
H6.100) DEVICE WILL NOT RUN ON AC OR DC POWER, NO AUDIBLE ALARM, AC POWER, NO AUDIBLE ALARM, AC POWER LED ONLY, DUE TO POWER SURGE. 66) DEVICE WILL NOT RUN ON AC OR DC POWER, NO AUDIBLE ALARM, AC POWER LED ONLY, DUE TO POWER SURGE. TESTING BY MFR FOUND UNIT WOULD NOT RUN ON AC OR DC POWER, NO AUDIBLE ALARM, AC POWER LED ONLY, DUE TO POWER SURGE TO DEVICE.
ON 6/22/920AN AUS DEVICE WAS IMPLANTED. ON 6/4/96 THE CUFF WAS REVISED. ON 10/1/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS AT JUNCTION OF PUMP AND TUBING.
THE DEVICE WAS USED FOR AN UNKNOWN PROCEDURE, IT WAS REPORTED BY THE REP THAT THE INSTRUMENT DOES NOT CUT OR FIRE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D5,6,10;H4 INFO NOT PROVIDED BY AFFILIATE. INSTRUMENT #2: ALL INFO IS THE SAME.
DURING AN UNKNOWN PROCEDURE, THE INSTURMENT DOES NOT FIRE OR CUT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D5,6,10;HR: INFO NOT PROVIDED BY AFFILIATE.
ON 8/1/83 AN AUS DEVICE WAS IMPLANTED. ON 12/21/83 THE CUFF AND PUMP WERE REVISED. ON 8/31/87 THE CUFF WAS REVISED. ON 10/1/96 DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO SUBSEQUENT INFECTION.
THE CONSUMER CALLED ON 9/23/96 ADVISING THAT SHE WAS SLEEPING WITH AUTO SHIFT OFF PAD ON TOP OF HER. EVEN THOUGH PAD STATES SHOULD NOT USE PRODUCT ON A SLEEPING PERSON. WHEN CONSUMER AWOKE, THE ARM HAD A BURN 2 1/2 INCHES LONG BY 1 IN WIDE. THEY IMMEDIATELY WENT TO THE DR. THEY CONFIRMED SHE HAD A THIRD DEGREE BURN ON HER ARM. CONSUMER GAVE THE HEAT PAD BACK TO DRUG STORE FOR THEM TO RETURN. THIS PRODUCT CANNOT BE LOCATED.
MAIN FRAME OF UNIT BROKE IN HALF WHILE CARRYING A 300 LB PT. PT AND TWO RESCUERS INJURED, UNK IF INJURIES ARE SERIOUS.
RE: H-6 (100) DEVICE EVALUATION IS IMCOMPLETE AS OF REQUIRED REPORTING DATE. RE: H-6 (68) NO CONCLUSION CAN BE DRAWN AS OF REQUIRED REPORTING DATE.
ON 9/23/93 AN AUS DEVICE WAS IMPLANTED. ON 12/27/95 THE CUFF WAS REVISED. ON 9/12/96 THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACTION - NEEDED HIGHER PRESSURE REGULATING BALLOON.
DURING AN UNKNOWN PRODUEDURE, THE INSTRUMENT DID NOT FIRE. THERE WAS NO CONSEQUENCE TO THE PT.
DURING SERVICE OF PRODUCT MOTOR CYCLED, NO VOLUME DELIVERED, WITH AUDIBLE AND VISUAL ALARMS, DUE TO 1ST STAGE GEAR BEING OUT OF SPECIFICATION. REPLACED 1ST STAGE GEAR.
DURING SERVICE OF PRODUCT A POTENTIAL NO LOW PRESSURE ALARM CONDITION WAS FOUND, DUE TO TRANSDUCER BEING OUT OF SPECIFICATION. REPLACED TRANSDUCER.
DDRING SERVICE OF PRODUCT DEVICE WAS FOUND TO NOT CYCLE, WITH ALL LEDS AND NO ALARM, DUE TO ACID SPILL ON LOGIC AND MOTOR BOARDS. REPLACED LOGIC AND MOTOR BOARDS. DEVICE RETURNED TO EVALUATE POSSIBLE INTERNAL DAMAGE DUE TO EXTERNAL BATTERY ACID SPILL.
H.6) 100-FAILURE DUE TO ACID SPILL ON LOGIC AND MOTOR BOARDS. LABELING-#1738.
DURING A CATARACT EXTRACITON PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
ON 9/20/96 CO RECEIVED A COMPLAINT CONCERNING ONE OF THE THEIR DEVICES. CUSTOMER REPORT THAT THE DEVICE WAS ALLEGEDLY BULGING.
PRODUCT IS SUBJECT OF COMPLAINT# P96-055. PRODUCT WAS RETURNED 9/20/96 FOR EVAL. EVAL DID NOT CONFIRM CUSTOMERS ALLEGATIONS THAT PRODUCT WAS BULGING. THE DEVICE PERFORMED ACCORDING TO INDICATED USAGE. ISOLATED REPORT.
DURING A CATARAXT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION UNIT INDICATED A PHACO CALIBRATION FAILURE MESSAGE. ANOTHER UNIT WAS USED FOR THE PROCEDURE.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICAITON HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
11/14/96 - THIS DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF IT IS RETURNED, RESULTS OF THE EVALUATION WILL BE FORWARDED AS FOLLOW-UP TO THIS REPORT.
THIS PHACOEMULSIFICATION HANPIECE COULD NOT BE CALIBRATED DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER HANDPIECE WAS USED.
THIS PHACOEMULSIFICATION UNIT EXHIBITS LOW PHACO POWER AND INTERMITTENT ASPIRATION DURING CATARACT EXTRACTION PROCEDURES.
DURING A VITRECTOMY PROCEDURE, THIS PHACOEMULSIFICATION UNIT WOULD NOT FUNCTION IN THE VITRECTOMY MODE. THE PHYSICIAN COMPLETED THE PROCEDURE, MANUALLY. THE PROCEDURE WAS EXTENDED 10-15 MINS.
DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA PROCEDURE. THE STAPLES WERE HANGING UP ON THE INSTRUMENT. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/4/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
PARTICULATE WAS SEEN IN THE EYES OF SEVERAL PTS FOLLOWING PHACOEMULSIFICATION USING THIS PHACOEMULSIFICATION HANDPIECE.
SECTIONS A-F WERE COMPLETED BY THE MFR. A FILTER TEST WAS PERFORMED ON THIS HANDPIECE AND EH HADPOECE PASSED. THE OCMPLAINT OF PARTICULATE COULD NOT BE DUPLICATED.
DEVICE WAS USED DURING A THORACTOMY. REPORTEDLY, THE STAPLES SIS NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/21/96-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVAL INDICATED AND CODES ENTERED IN H3 AND H6.
THE DEVICE WAS USED DURING A THORACTOMY. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/22/96-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
DEVICE WAS NOT CLINICALLY APPLIED. REPORTEDLY, THE VISIBILITY WAS NOT CLEAR PRIOR TO USE.
11/4/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. CO FOREIGN SUBSIDARY WAS INFORMED OF THIS EVENT ON AUG. 21 1996. HOWEVER, CORP. WAS NOT INFORMED UNTIL 10/10/96. CO FOREIGN SUBSIDARY WILL BE RE-INSTRUCTED REGARDING THE STATUTORY REPORTING REQUIREMENTS OF THE MDR REG.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
10/31/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/31/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
THE SUTURE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, CLIPS DID NOT LOAD PROPERLY INTO THE INSTRUMENT JAWS. NO PT INJURY REPORTED.
10/31/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. DUE TO A CLERICAL ERROR, THE STATUTORY REPORTING REQUIREMENT OF 30 CALENDAR DAYS TO REPORT WAS EXCEEDED.
10/31/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DUE TO CLERICAL ERROR, THE STATUTORY REPORTING REQUIREMENT OF 30 CALENDAR DAYS TO REPORT WAS EXCEEDED.
11/31/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DUE TO A CLERICAL ERROR, THE STATUTORY REPORTING REQUIREMENT OF 30 CALENDAR DAYS TO REPORT WAS EXCEEDED.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT PREMATURELY EJECTED UNFORMED CLIPS. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE SUTURE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. NO PT INJURY REPORTED.
10/31/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DUE TO A CLERICAL ERROR, THE STATUTORY REPORTING REQUIREMENT OF 30 CALENDAR DAYS TO REPORT WAS EXCEEDED.
THE DEVICE WAS USED DURING A HEPATECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. NO PT INJURY REPORTED.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE PNEUMOPERITONEUM LEAKED FROM THE TROCAR. NO PT INJURY REPORTED.
12/29/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. PRODUCT NOT AVAILABLE FOR EVAL.
THE DEVICE WAS BEING UTILIZED FOR PLACEMENT OF A PERFUSION CATHETER IN THE AREA OF THE BIFURCATION OF THE CIRCUMFLEX ARTERY AND UPWARD. FOLLOWING THE PROCEDURE, ATTEMPTED MANIPULATION OF THE WIRE GUIDE WAS NOT SUCCESSFUL. THE WIRE GUIDE WAS THEN WITHDRAWN AT WHICH TIME TIP SEPARATION WAS NOTED ON THE MONITOR. THE PHYSICIAN WAS UNABLE TO SNARE THE SEGMENT WITH A RETRIEVAL LOOP. THE PT WAS TRANSFERRED TO SURGERY FOR REMOVAL OF THE SEGMENT AND CABG OF THE RCA.
THE RETURNED WIRE GUIDE APPEARS TO HAVE BEEN MFG ACCORDING TO SPECIFICATIONS. HOWEVER, CO DOES CONFIRM THAT THE DISTAL TIP HAS SEPARATED. THE APPEARANCE OF THE DAMAGE AND THE PRESENCE OF SEVERAL KINKS SUGGESTS THAT THE WIRE GUIDE MAY HAVE BEEN WITHDRAWN THROUGH A NEEDLE. CO CAN ADVISE CO CAUTIONS IN THE LABELING THAT, "WITHDRAWAL OR MANIPULATION OF DISTAL SPRING COIL PORTION OF WIRE GUIDE THROUGH NEEDLE TIP MAY RESULT IN BREAKAGE." THIS DEVICE INS INSPECTED 100% IN QUALITY CONTROL PRIOR TO SHIPMENT.
DR REPORTED THAT AN ABUTMENT BROKE IN FUNCITON. PT IS REPORTEDLY FINE.
H6. RESULTS-CODE 200 & CODE 400(NOT ENOUGH INFO RECEIVED TO DETERMINE CAUSE.
PT WAS HAVING AN ANGIOGRAPHIC EVALUATION FOR STENOSIS OF AN AV DIALYSIS SHUNT. AT THE END OF THE PROCEDURE, AFTER THE ANGIOPLASTY OF THE SHUNT, WITH A PTCA CATHETER, THE CATHETER WAS BEING REMOVED WITH NO EXCESSIVE FORCE. THE REPEAT ANGIOGRAM AT THIS TIME REVEALED A SMALL FILLING DEFECT WITH ASSOCIATED RADIO-OPAQUE MARKERS WITHIN THE PROXIMAL PORTION OF THE GRAFT LIMB. THE DISTAL AND BALLOON TIP OF THE CATHETER HAD BROKEN OFF. IMMEDIATE INTERVENTION WITH A BASKET RETRIEVAL CATHETER WAS PERFORMED AND REMOVED THE DISTAL END OF THE CATHETER. HOWEVER, THE BALLOON TIP WAS NOT PRESENT. A SURGICAL CONSULT WAS OBTAINED, PT TAKEN TO OR AND THE BALLOON TIP REMOVED.
DR REPORTED THAT TWO IMPLANTS FAILED TO INTEGRATE. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENTS THEMSELVES. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCTS COULD NOT BE COMPLETED SINCE THE LOT NUMBERS WERE NOT AVAILABLE FROM THE DOCTOR'S OFFICE.
IDE REVISION SURGERY (G870035 #0201-256/LT) PT HAD A PAST HISTORY OF SUSTAINING A FALL, LANDING ON HER BILATERAL KNEES WITH KNEE PAIN. ON PRESENTATION, REPORTED PAIN HAD BEEN PRESENT SINCE LAST JANUARY AND HAD BEEN UNABLE TO AMBULATE OVER THE PAST MONTH. SHE REQUIRED A WHEELCHAIR FOR AMBULATION. SHE IS STATUS POST A RIGHT TOTAL KNEE ARTHROPLASTY DURING 1989, A LEFT TOTAL KNEE ARTHROPLASTY DURING 1990, AND A LEFT PATELLA REALIGNMENT AFTER THE SUSTAINED FALL IN 1996. PT WAS TAKEN TO SURGERY FOR REVISION OF THE RIGHT TOTAL KNEE PROSTHESIS. QUADRICEP TENDON WAS FOUND TO BE EITHER AVULSED OR RUPTURED FROM THE PATELLA. UPON OPENING KNEE, SHE WAS NOTED TO HAVE SOME FRAGMENTS OF POLY, WHICH WERE DEBRIDED. MINIMAL EROSION AROUND THE ANTERIOR ASPECT OF THE TIBIAL BASEPLATE. SYNOVIUM OF THE KNEE WAS DISCOLORED. A SYNOVECTOMY WAS PERFORMED AND FLAKES OF POLYETHYLENE, AS WELL AS SOME DEBRIS WAS FOUND WITHIN THE SYNOVIUM. POLYETHELYNE HAD DETAMINATED OFF THE PATELLA.
H6. METHOD; 88 OTHER-DEVICE HISTORY REVIEWED IN CONJUNCTION WITH INFO CONTAINED IN USER FACILITY MEDWATCH 3500A. H6.RESULTS, 100 OTHER-DEVICE NOT RETURNED. 200 OTHER-UNK. H6. CONCLUSIONS: PT'S FALL CONTRIBUTED TO THE FAILURE OF DEVICE.
AT 11AM INFUSION PUMP WAS ALARMING. SCREEN AND LOWED MALFUNCTION #9. ATTEMPTS TO SHUT OFF MACHINE BY NURSE WITHOUT SUCCESS. ATTEMPTED TO CHARGE BATTERY, PUMP WENT INTO MALFUNCTION #8. PUMP STILL DID NOT TURN OFF. CALLED MFR TO FIND OUT WHAT #8 AND #9 MALFUNCTION MEANT, CO HAD NO ANSWER. PROCEDURE BOOK BY CO HAD NO ANSWER. PUMP ASSESSED BY NURSE TO DETERMINE AMOUNT REMAINING IN CARTRIDGE. ALL FLUIDS GONE THRU (SHOULD HAVE BEEN 280 MG LEFT). RESIDENT'S VITAL SIGNS VISIBLY STABLE. RESIDENT WAS LETHARGIC BUT AROUSABLE. 1:1 WITH 15 NEC VITALS FOR 2 HRS. TWO HRS AFTER THE INCIDENT RESPIRATIONS AT 8. NARCAN 0.4 NG WAS ADMINISTERED 4 TIMES DURING THE COURSE OF 8 HRS. RESIDENT RETURNED TO BASELINE 10/15/96 AT 9AM.
VALVE EXPLANTED FOR THROMBUS. PANNUS FORMATION ON VALVE FOLLOWING EXPLANT. NO OTHER INFO AVAILABLE AT THIS TIME.
INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH CO SPECIFICATIONS AT THE TIME OF MFR. RESULTS OF THIS INVESTIGATION INDICATED THIS VALVE WAS EXPLANTED DUE TO THROMBOSIS, WHICH ESSENTIALLY IMMOBILIZED BOTH LEAFLETS. THE CAUSE OF THE THROMBOSIS REMAINS UNK. THE PANNUS FORMATION OBSERVED BY DR. ALSO RESTRICTED LEAFLET MOTION. PAGES = 2.
PER THE INFO PROVIDED TO CO THROUGH THE INTERNATIONAL REPRESENTATIVE, THE DEVICE WAS REMOVED DUE TO "INABILITY TO INFLATE/DEFLATE." 10/8/96-UPON RECEIPT OF THE PHYSICIAN/SURGEON RESPONSE SENT WITH THE EXPLANTED PROSTHESIS, IT STARTED "TUBING CRACKED WIDE-OPEN AT THE JUNCTION OF PUMP TUBING TO THE CYLINDER, THIS WAS THE LEAKAGE SITE."
IN RECEIVED QUESTIONNAIRE, PHYSICIAN INDICATED FOLLOWING: A SPECIFIC, EASILY IDENTIFIABLE LEAKAGE SITE WAS OBSERVED AT JUNCTION OF PUMP TUBING TO A CYLINDER, NO NOTICEABLE TWISTING OF TUBING WAS OBSERVED WHEN DR OPENED POCKET, NO EXCESSIVE NOR INADEQUATE TUBING LEGHTS WERE OBSERVED AT IMPLANT, NOTHING WAS NOTED IN POSITIONING THAT MAY HAVE CAUSED STRESS(ES) TO DEVICE, THERE WAS NO INFO APPARENT IN PT'S HISTORY WHICH MAY HAVE CONTRIBUTED TO THIS OCCURRECE, ANC CRACK IN TUBING IS EASILY INDENTIFIABLE AND WAS NOT A RESULT FROM REMOVAL. PUMP, TWO CYLINDERS, AND RESERVOIR WERE RECEIVED AND EVALUATED BY MFR. DURING FUNCIONAL TESTING, A LEAKAGE SITE WAS OBSERVED FROM A SEPARATION OF PUMP'S SERIALIZED OUTLET STRAIN RELIEF. A MICROSCOPIC EXAMINATION OF LEAKAGE SITE REVEALED NO INDICATIONS OF CONTACT WITH SHARP INSTRUMENTATION ON CROSS SECTIONAL SURFACES, INDICATING A TUBING TEAR. TUBING WAS ENTIRELY SEPARATED FROM STRAIN RELIEF. TUBING AND STRAIN RELIEF WERE HELD TOGETHER BY TWO PORTIONS OF NOMOFILAMENT. BASED ON RECEIVED INFO AND QUALITY ASSURANCE'S EVAL, QA CONCLUDES THAT A LEAKAGE SITE EXISTED AT SERIALIZED STRAIN RELIEF JUNCTION. THIS LEAKAGE SITE, WHILE IN VIVO, WOULD HAVE CAUSED A FLUID LOSS FROM DEVICE AND WOULD HINDER INFLATING OF DEVICE. BASED ON LIMITED INFO RECEIVED, QA IS PRECLUDED FROM DETERMINING NATURE OF THESE STRESSES.
DENTAL ASSISTANT WAS WIPING DOWN ROOM WITH SOLUTION AND A SMALL AMOUNT OF SOLUTION SPLASHED IN HER EYE. ASSISTANT WAS WEARING CONTACTS. EYE WAS RINSED WITH WATER. EYE BURNED FOR ABOUT ONE HR. OPTOMETRIST TOLD HER TO CLEAN CONTACT. ONE WEEK LATER EYE STIU REPORTED TO BE INITIATED AND ASSISTANT STILL HAS NOT GONE TO SEE A DR.
WEEK AFTR INCIDENT THE ASSISTANT STILL HAS NOT SEEN A DR. (EYE IS STILL IRRITATED)
IMPLANT DID NOT INTEGRATE AND WAS REMOVED. ONE PERSON AFFECTED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
ADMIT DX: CATARACT EXTRACTION. WHILE TESTING THE PHACO HANDPIECE AND FOOT PEDAL PRIOR TO STARTING THE MAIN PHACOEMULSIFICATION PART OF THE CATARACT SURGERY, IT WAS NOTED THAT THE MACHINE WAS NOT WORKING IN THE PHACO OR ASPIRATION MODE. A DIFFERENT PHACO FOOT PEDAL, HANDPIECE AND TUBING WAS USED. STILL NO PHACO OR ASPIRATION MODE. THE MACHINE WAS THEN CHANGED OUT. PER THE PHYSICIAN, THE ANESTHESIA WAS STARTING TO WEAR OFF AND THE CORNEA STARTED TO BECOME MODERATELY HAZY. THE PHYSICIAN DETERMINED IT WAS NOT PRUDENT TO CONTINUE AS THE EDGES OF THE CORTEX COULD NOT BE SEEN WELL ENOUGH. PT WILL HAVE TO HAVE AN ADD'L PROCEDURE DONE AFTER THE EYE HEALS TO HAVE THE CORTEX REMOVED AND TO PLACE AN INTRAOCULAR LENS.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO A "TUBING SPLIT." AS REPORTED TO CO THE ENTIRE DEVICE WAS REMOVED AND REPLACED.
ACCORDING TO AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS REMOVED ON 9/10/96 DUE TO A "TUBING SPLIT." NO IMPLANT INFO WAS PROVIDED. REQUESTS FOR EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER DEVICE NOR INFO HAVE BEEN RECEIVED. WITHOUT BENEFIT OF ANALYZING EXPLANT WITHOUT REQUESTED INFO, QA IS PRECULDED FROM COMMENTING ON CONDITION OF DEVICE OR EVENTS SURROUNDING THIS INCIDENT. SHOULD EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN LABELING OR USUAL FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION.
WHILE RESETTING UNIT AT THE CLINIC, MACHINE WENT BEYOND EXTENSION PARAMETERS. HEALTH PROVIDER STOPPED DEVICE, TOOK PT OUT, AND ICE WAS APPLIED. PT COMPLAINED OF PAIN. PT CALLED DR WHO ADVISED PT TO STOP DEVICE USE FOR 1 WEEK. IF PAIN PERSISTS, PT TO DR. AT THIS TIME NO MEDICAL INTERVENTION NEEDED.
EXPLANTED FOR PANNUS OVERGROWTH. NO OTHER INFO IS AVAILABLE AT THIS TIME.
INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH CO SPECIFICAITONS AT THE TIME OF MFR. RESULTS OF THIS INVESTIGATION REMAIN INCONCLUSIVE DUE TO THE FACT CO HAS NOT RECEIVED ADDITIONAL INFORMATION WHICH MAY HAVE AIDED IN THE EVALUATION OF THE VALVE. TESTING PERFORMED AT CO INDICATED THIS VALVE WAS NOT EXPLANTED DUE TO AN INTRINSIC DEFECT. THE REPORTED PANNUS OVERGROWTH DID NOT APPEAR TO IMPEDE THE LEAFLETS, AS SUPPORTED BY DR.. THE LARGE AMOUNT OF PANNUS GROWTH MAY HAVE DECREASED THE AMOUNT OF BLOOD FLOW ACROSS THE INSIDE DIAMETER OF THE ORIFICE, RESULTING IN THE SURGEON'S DECISION TO EXPLANT THE VALVE.
AS THE LOT NUMBER WAS UNK, A REVIEW OF THE DEVICE HISTORY COULD NOT BE CONDUCTED. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN, THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION." AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A CO'S 3-PIECE INFLATABLE PENILE PROSTHESIS.
ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 11/10/87 AND REMOVED ON 9/18/96 DUE TO A "MALFUNCTION" A PUMP, TWO CYLINDERS, A RESERVOIR, AND ASSOCIATED CONNECTORS AND REAR TIP EXTENDERS WERE RETURNED FOR EVALUATION. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFO SURROUNDING THE INCIDENT, HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUND THE INCIDENT. SHOULD ADDITIONAL INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED TWO AREAS OF LEAKAGE. THE FIRST IS LOCATED NEAR THE DISTAL TUBE END OF OUTLET #1. SEVERAL SMALL SEPARATIONS ARE NOTED AT THIS SITE. THE SEPARATIONS ARE NOTED TO BE IN A LINEAR PATTERN AND EXMAINATION OF THE SURFACES OF THE SEPARATIONS REVEALED MARKINGS INDICATING CONTACT WITH SHARP, UNSHOD INSTRUMENTATION. THE SECOND AREA OF LEAKAGE IS NOTED NEAR THE DISTAL TUBE END OF THE INLET TUBING ON THE RESERVOIR. NUMEROUS SMALL SEPRATIONS ARE OBSERVED AT THIS SITE. THESE SEPARATIONS ARE ALSO IN A LINEAR PATTERN AND DISPLAY MARKINGS INDICATING CONTACT WITH SHARP, UNSHOD INSTRUMENTATION. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MFG AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT THE OBSERVED DAMAGE OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. HOWEVER BECAUSE IMPLANT INFO WAS NOT PROVIDED, QA IS PRECLUDED FROM DETERMINING THE SEQUENCE OF EVENTS LEADING TO THE OBSERVED DAMAGE. NO OTHER FUNCTIONAL ABNORMALITIES WERE OBSERVED, HOWEVER ALL OF THE CONNECTOR/CLAMP ASSEMBLIES WERE RETURNED DISASSEMBLED, AND QA IS THEREFORE PRECLUDED FROM DETERMINING IF THEY CONTRIBUTED TO THE REPORTED "MALFUNCTION." BECAUSE THE AVAILABLE INFO DI DNOT PROVIDE ANY INDICATIONS AS TO WHAT FACTOR(S) MAY HAVE CONTRIBUTED TO THE REPORT OF A DEVICE "MALFUNCTION", QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED EVENT. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
PT COMPLAINED OF PAIN TO MD, SO HE REMOVED THE PLATE AND SCREWS. UPON REMOVAL, CORROSION WAS NOTED.
AS THE LOT NUMBER WAS UNK, A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED. THE RETURNED IMPLANT WAS EVALUATED. IT WAS FOUND TO BE A 3.75 X 10 SELF-TAPPING IMPLANT, NOT THE REPORTED 3.75 X 10 SELF-TAPPING IMPLANT. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
ORTHOPEDIC SURGEON CONTACTED CO TO REPORT THAT ABSORBABLE TAPERED PINS HAD NOT ABSORBED IN PT AFTER 6 MONTHS FOLLOWING RADIAL HEAD FRACTURE REPAIR. HE REPORTED THAT THE RADIOLUSCENT PINS COULD BE SEEN ON X-RAY.
B2 & H6 METHOD CODE 81. A CO SALES AGENT VISITED WITH THE SURGEON. EXAMINED X-RAYS, AND DETERMINED THAT THE NONABSORBABLE METAL K-WIRE PORTIONS OF TAPERED PINS HAD BEEN IMPLANTED. K-WIRES ARE NOT INTENDED FOR IMPLANTATION. INSTRUCTIONS PROVIDED ON PACKAGE INSERTS ACCOMPANYING THE TAPERED PINS WERE NOT FOLLOWED. X-RAY EXAMINATION FOUND ONE K-WIRE APPEARS TO HAVE MIGRATED INTO THE JOINT REDUCING RANGE OF MOTION. THE SECOND K-WIRE APPEARS TO BE BENT AND TO HAVE MIGRATED DEEPER INTO THE BONE. A REVIEW OF PT RECORDS ALSO FOUND ONE PIN TO HAVE BEEN IMPLANTED BEYOND ITS EXPIRATION DATE WITH THE DATE UNDERLINED IN THOSE RECORDS. THE DATE WAS NOT PROVIDED TO CO BY THE SALES AGENT. IT IS UNK IF OR WHEN THE K-WIRES WILL BE REMOVED. NOTE: THE INFO IN SECTION F IS BEING SUPPLIED BY THE MFR AND NOT THE USER FACILITY. NO MEDWATCH FORM HAS BEEN REC'D FROM THE USER FACILITY.
PER THE INFO PROVIDED TO CO THROUGH MEANS OF THE PHYSICIAN/SURGEONS OPERATIVE REPORT "INDICATIONS: THE PT HAS A PENILE PROSTHESIS PLACED A LITTLE MORE THAN 2 1/2 YRS AGO. IT HAS BEEN NONFUNCTIONING SINCE THAT TIME. FINDINGS: IT WAS NOTED WHEN WE REMOVED THE PENILE PROSTHESIS THAT THERE WAS A SMALL HOLE IN THE END OF THE ONE CYLINDER. WE ATTEMPTED TO USE THE RESERVOIR THAT WAS IN PLACE, BUT WE WERE NOT TOO COMFORTABLE WITH THIS, THEREFORE, WE PUT IN A NEW RESERVOIR AND LEFT THE RESERVOIR JUST TO THE RIGHT OF THE MIDLINE. THE DEVICE THAT WAS PLACED WAS A PENILE PROSTHESIS.
EVAL AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE. EVAL IS PENDING DECONTAMINATION, EXAM AND TESTING OF THE RETURNED DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION.
PT HAD BEEN STARTED ON PUMP ON 10/9/96, 1000MG CASSETTE. PT'S DAUGHTER WAS INSTRUCTED AS TO PROPER SETUP AND OPERATION OF DEVICE, INCLUDING LOCKOUT KEY OPERATION. PT'S WIFE WAS UNABLE TO AROUSE PT AT 1655 AND CALLED 911. RESPIRATIONS DIMINISHED TO 6 RPM. PT TRANSFERRED TO ER. PUMP WAS FOUND TO BE SEPARATED FROM CASSETTE, AND CASSETTE EMPTY. UPON INSPECTION, IT WAS FOUND THAT THE KEY LOCK MECHANISM WOULD REMAIN DEPRESSED WITHOUT ROTATING THE LOCKING MECHANISM WITH THE USE OF THE LOCKING KEY. THIS WAS CAUSED BY A SMALL FLAT PIECE OF THE TUBING BINDING AGAINST THE LOCKING MECHANISM. THIS GAVE THE IMPRESSION THAT THE CASSETTE WAS SECURELY LOCKED IN PLACE.
PER THE INFO PROVIDED TO CO BY PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO A "FLUID LOSS." AS REPORTED TO CO THE ENTIRE DEVICE WAS REMOVED.
WHILE PERFORMING CRANIOTOMY FOR TUMOR, THE PERFORATOR TORE THE DURA AND PLUNGED TO SUPERFICIAL CORTEX WHITE MATTTER OF TEMPORAL LOBE.
THERE WERE NO DISCREPANCIES NOTED IN THE MFG HISTORY RECORDS FOR THIS LOT. DEVICE WAS VISUALLY INSPECTED. HARDENED CASE DEBRIS AND SOME RUST WAS NOTED ON THE UNIT. THE DEBRIS AND RUST WAS REMOVED AND THE UNIT WAS TESTED FOR PROPER FUNCTION AND PERFORMANCE PROPERLY FOR TEN TEST HOLES. THE REPORTED FAILURE COULD NOT BE REPEATED. THE INTERNAL COMPONENTS APPEARED NORMAL.
PER THE INFO PROVIDED TO CO BY THE HOSP, THE DEVICE WAS REMOVED AS IT WAS "DEFLATED" SECONDARY TO "NO FLUID IN THE SYSTEM". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH CO'S 3-PIECE INFLATABLE PENILE PROSTHESIS.
DURING FUNCTIONAL TESTING, LEAKS WERE OBSERVED IN THREE DIFFERENT AREAS OF THE DEVICE. ONE WAS LOCATED IN THE PUMP'S SERIALIZED OUTLET TUBING, NEAR THE DISTAL CONNECTOR. ANOTHER WAS LOCATED IN THE RESERVOIR BLADDER. THE THIRD WAS LOCATED IN ONE OF THE CYLINDER BLADDERS. GENERAL OBSERVATION AND MICROSCOPIC EXAMINATION OF THE DEVICE WAS PERFORMED. 1) THE CROSS SECTIONAL SURFACES OF THE PUMP TUBING LEAKAGE SITE WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. THE TUBING WAS RECEIVED BENT IN AN ATYPICAL POSITION, INDICATING THAT WHILE IN-VIVO THIS TUBING WAS RESTING IN A STRESSFUL POSITION. ABRASION WAS LOCATED ON ALL THREE PUMP TUBES. BASED ON THE PATTERN OF ABRASION, THE INLET TUBE HAD WRAPPED AROUND OUTLET #1. 2) THE CROSS SECTIONAL SURFACES OF THE CYLINDER BLADDER LEAKAGE SITE WERE UNIFORMLY STRIATED, INDICATING CONTACT WITH SHARP INSTRUMENTATION, SUCH AS A SCALPEL OR SCISSORS. 3) THE RESERVOIR BLADDER LEAKAGE SITE WAS CONTAINED IN AN AREA OF SURFACE CRAZING. MULTIPLE SEPARATIONS WERE LOCATED WITHIN THE AREA OF SURFACE CRAZING. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCE'S EVALUATION, QA CONCLUDES THE FOLLOWING: 1) THE DEVICE'S IN-VIVO POSITIONING CONTRIBUTED TO THE PUMP'S TUBING TEAR. THE RESULTING LEAK WOULD CAUSE THE REPORTED FLUID LOSS AND CAUSE THE DEVICE TO DEFLATE. 2) LEAKAGE OBSERVED FROM THE SURFACE CRAZING IS CONSISTENT WITH ENVIRONMENTAL STRESS FRACTURES OBSERVED WITH MEDICAL IMPLANTABLE DEVICES. VARIOUS EXTERNAL FACTORS CAN CONTRIBUTE TO THE PRESENCE AND EXTENT OF SURFACE CRAZING, HOWEVER, QA IS UNABLE TO IDENTIFY THESE FACTORS. THIS LEAKAGE WOULD ALSO CAUSE A FLUID LOSS FROM THE DEVICE AND CAUSE IT TO DEFLATE. 3) THE CYLINDER LEAKAGE SITE WAS CAUSED BY CONTACT WITH SHARP  INSTRUMENTATION DURING OR SUBSEQUENT TO EXPLANT SURGERY, AND THEREFORE IS NOT RELATED TO THE REASON FOR REMOVING THE DEVICE.
PER THE INFORMANTION PROVIDED TO CO BY THE HOSPITAL, THE DEVICE WAS REMOVED DUE TO A "TUBING FRACTURE NEAR THE RESERVOIR", SECONDARY TO A "FLUID LOSS". 10/28/96-UPON RECEIPT OF INFORMATION PROVIDED TO CO BY THE PHYSICIAN'S OFFICE IT WAS STATED, "THERE WAS A SPECIFIC LEAKAGE SITE OBSERVED IN THE RESERVOIR TUBING BETWEEN THE CONNECTION AND RESERVOIR". AS REPORTED TO CO THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CO'S 3 PIECE INFLATABLE PENILE PROSTHESIS.
IN A RETURNED QUESTIONNAIRE, THE PHYSICIAN INDICATED THE FOLLOWING: A SPECIFIC LEAKAGE SITE WAS OBSERVED IN THE RESERVOIR TUBING BETWEEN THE CONNECTOR AND THE RESERVOIR, THE DOCTOR DID NOT NOTICE WHETHER THE TUBING WAS KINKED OR TWISTED AROUND EACH OTHER WHEN HE OPENED THE POCKET, WHEN THE DEVICE WAS IMPLANTED THERE WAS NOT EXCESSIVE TUBING LENGTH OBSERVED, WHEN IMPLANTED INADEQUATE TUBING LENGTH WAS OBSERVED, NOTHING WAS NOTED IN THE POSITIONING THAT MAY HAVE CAUSED STRESS(ES) TO THE DEVICE, THERE WAS NO INFO APPARENT IN THE PT'S HISTORY WHICH MAY HAVE CONTRIBUTED TO THIS OCCURRENCE, THE DEVICE WAS NOT IN CONTACT WITH ANY UNSHOD, SHARP INSTRUMENTATION DURING OR SUBSEQUENT TO REMOVAL. TWO CYLINDERS, THE RESERVOIR, AND THE PUMP WERE RECEIVED AND EVALUATED BY THE MFR. AN OBVIOUS LEAKAGE SITE EXISTED IN THE RESERVOIR TUBING. MICROSCOPIC EXAMINATION OF THE LEAKAGE SITE SHOWED THAT THE CROSS SECTIONAL SURFACES WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. BASED ON THE RESEIVED INFO AND QUALITY ASSURANCE TESTING AND EXAMINATION, QA CONCLUDES THAT THE LEAKAGE SITE IN THE RESERVOIR TUBING CAUSED THE PT'S FLUID LOSS. THE TUBING TEAR THAT CAUSED THIS LEAK RESULTED FROM DEVICE USAGE OVER TIME. INADEQUATE TUBING AT IMPLANT, AS THE PHYSICIAN NOTED, MAY HAVE CONTRIBUTED TO THIS OCCURRENCE.
ON THE THIRD HOLE, THE PERFORATOR TORE THE DURA AND SCRAPED/IMPOSED ON BRAIN TISSUE. DRILL BECAME LODGED IN SKULL AND HAD TO BE REMOVED USING PLIERS.
IT IS UNK AT THIS TIME IF THE DEVICE WILL BE RETURNED TO CO FOR EVAL. CO HAS REQUESTED THE RETURN OF THE DEVICE. NOTE: THE INFO IN SECTION F IS BEING SUPPLIED BY THE MFR AND NOT THE USER FACILITY. NO MEDWATCH FORM HAS BEN REC'D FROM THE USER FACILITY.
MESH USED DURING COLPOSACROPEXY AND PELVIC FLOOR REPAIR. 10 DAYS POST-OP, PT REOPERATED FOR BOWEL ADHESION IN THE AREA.
PT HAD A PTCA PROCEDURE. DURING THAT PROCEDURE A STENT WAS PLACED AND IT BENT. A BALLOON CATHETER WAS BEING USED TO MANIPULATE THE STENT AND IT RUPTURED. PT WAS SENT TO OR TO REMOVE THE STENT AND HAVE 3 VESSEL CABG.
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 4/27/92 AND REMOVED ON 10/3/96 DUE TO A "MALFUNCTION." A PUMP, TWO CYLINDERS, A RESERVOIR, AND ASSOCIATED CONNECTORS AND REAR TIP EXTENDERS WERE RETURNED FOR EVALUATION. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFORMATION HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFORMATION, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED DEVICE REVEALED A COMPLETE SEPARATION OF OUTLET #1'S STRAIN RELIEF. EXAMINATION OF THE SURFACES OF THE SEPARATION, BOTH ON THE PUMP AND CYLINDER SIDE, REVEALED MARKINGS CHARACTERISTIC RELIEF/TUBE JUNCTION, ON THE DETACHED PORTION OF THE EXITING TUBING., AN AREA OF ABRASION AND A CREASE MARK ADJACENT TO THE AREA OF ABRASION. EXAMINATION AND TESTING ALSO REVEALED A LEAKAGE SITE NEAR THE DISTAL TUBE END OF THE INLET TUBING. THIS SITE CONSISTS OF SEVERAL SMALL SEPARATIONS IN A LINEAR PATTERN. EXAMINATION OF THE SURFACES OF THESE SEPARATION REVEALED MARKINGS INDICATING CONTACT WITH SHARP UNSHOD INSTRUMENTATION. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MFG AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT THE OBSERVED DAMAGE OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. IN ADDITION, BECAUSE THE EXPECTED USE OF THIS DEVICES COMBINED WITH THE OBSERVED DAMAGE WOULD HAVE RESULTED IN AN EARLIER DETECTED FLUID LOSS, QA CONCLUDED THAT THE DAMAGE MOST LIKELY OCCURRED AT OR SUBSEQUENT TO EXPLANT. BASED ON QA'S EXAMINATION AND THE LIMITED INFORMATION PROVIDED, QA CONCLUDED THAT OUTLET #1'S EXITING TUBE WAS PARTIALLY KINKED AND ABRADING AGAINST ITSELF. QA FURTHER CONCLUDED THAT THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE STRAIN RELIEF AT THE OBSERVED SITE. THIS RENT WOULD HAVE ALLOWED THE LOSS OF FLUID AND RENDERED THE DEVICE INOPERABLE.
PER THE INFORMATION PROVIDED TO CO BY HOSPITAL, THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED.
A 65 YR OLD WOMAN WAS INPATIENT FOR CORONARY ARTERY SURGERY. SECONDARY DIAGNOSIS ARE HYPOTENSION, HYPERLIPIDEMIA AND DIABETES. THE PT RECEIVED ON A CHRONIC BASIS SEVERAL MEDICATIONS, AND AT THE TIME OF THE TRANSFUSION DOPAMINE, HEPARIN ET AL. ONE MINUTE INTO THE POST-SURGICAL TRANSFUSION, THE PT'S BLOOD PRESSURE FELL FROM 110 MMHG TO 65 MMHG. THE TRANSFUSION WAS STOPPED. NO REPORTS OF ADVERSE SEQUELAE WERE REPORTED.
APPROX 3 MINUTES AFTER BEGINNING OF TRANSFUSION, THE PT'S BLOOD PRESSURE DECREASED AND A SLIGHT PULSE DECREASE. PT WAS GIVEN NEOSYNEPHRINE IN ORDER TO STABILIZE, WHICH WAS UNSUCCESSFUL AND THE TRANSFUSION WAS STOPPED. THE TRANSFUSION WAS STARTED AGAIN, DECREASE IN BLOOD PRESSURE WAS OBSERVED AND TRANSFUSION WAS STOPPED AGAIN.
AFTER PRIMING THE SET WAS NOTED TO BE LEAKING AND AIR WAS NOTED BELOW THE PUMP TO THE LUER. THE SET WAS NOT CONNECTED TO A PT.
THERE IS NO PT INFO IN SECTION A 1-4 OR SECTION B 6 7 AND SECTION F-2,6 BECAUSE THE SET WAS NOT CONNECTED TO A PT AND NO REPORT WAS FILED BY THE USER FACILITY. THE SET WAS VISUALLY EXAMINED. IT WAS NOTED THAT THE SENSING DISC FILM HAD BEEN CUT IN A SEMI CIRCULAR FASHION AT THE TOP OF THE SENSING DISC. THE TOP REAR CHANNEL HAD BEEN DAMAGED AND SHOWED MARKS FROM THE INSTRUMENT'S DOOR PIN. THIS DAMAGE IS CONSISTANT WITH MISLOADING THE SENSING DISC INTO THE INSTRUMENT. ADD'L INSERVICE OF PROPER SET LOADING HAS BEEN RECOMMEMDED. IN ADDITION, THE HOSPITAL HAS BEEN INFORMED THAT A SET LOADING GUIDE FOR THE MODEL 560 SERIES INSTRUMENT IS AVAILABLE THAT ASSISTS THE USER IN PROPERLY LOADING THE SENSING DISC INTO THE INSTRUMENT. MFR'S REPORT DATE 9/19/96.
ORTHOPAEDIC SURGEON FOUND "LEFT/RIGHT" ORIENTATION MARKINGS ON WRONG/OPPOSITE SIDES OF BUSHING DURING KNEE REPLACEMENT SURGERY ON 10/22/92 AND DID NOT USE THE BUSHING. SURGEON NOTED THAT THE SAME BUSHING HAD BEEN USED IN SURGERY ON 10/17/96 AND BELIEVES BONE CUTS MAY HAVE BEEN INCORRECT DUE TO INCORRECT MARKINGS.
H3 EVAL SUMMARY: VISULAL EXAMINATION OF RETURNED BUSHING FOUND "LEFT/RIGHT" ORIENTATION MARKINGS TO BE ON OPPOSITE/INCORRECT SIDES OF THE BUSHING. CO INVENTORY WAS AUDITED AND ALL BUSHINGS FOUND TO HAVE CORRECT MARKINGS. NO FURTHER ACTION IS PLANNED. B2-NO INFO HAS BEEN MADE AVAILABLE CONCERNING PT'S CONDITION. THERE ARE NO PLANS FOR ADD'L SURGERY AT THIS TIME. NOTE: THE INFO IN SECTION F IS BEING SUPPLIED BY THE MFR AND NOT THE USER FACILITY. NO MEDWATCH FORM HAS BEEN REC'D FROM THE USER FACILITY.
REFERENCE F.10 OF THIS FORM FOR THE EVENT ROBLEM CODES.
RECEIVED SUMMONS FROM PT'S ATTORNEY. PT ALLEGED HE EXPERIENCED A SEVERE CORNEAL INFECTON AND ULCERATION WHICH DAMAGED HIS CORNEA CAUSING A PERMANENT LOSS OFE VISION.
ALL OF  SECTION F -INFO PROVIDED BY MFR.
THE DEVICE WAS APPLIED DURING A LOBECTOMY PROCEDURE. THE INSTRUMENT MISFIRED. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
9/20/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
SUMMONS AND COMPLAINT REC'D ALLEGING TSS.
1 PERSON SERIOUS INJURY TYPE G. 510K # 912002.
THE DEVICE WAS USED DURING A HYSTERECTOMY PROCEDURE. STAPLES DID NOT FORM PROPERLY. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
1 PERSON SERIOUS INJURY TYPE G. 510K #912002.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED AS IT WAS "NOT LONG ENOUGH AND DID NOT WORK". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH CO'S 3-PIECE INFLATABLE PENILE PROSTHESIS.
EVAL IS PENDING DECONTAMINATION, EXAM AND TESTING OF THE RETURNED SERVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OF SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION.
IT WAS REPORTED THAT A 73 YEAR OLD WOMAN WAS AN INPATIENT CANDIDATE FOR A MITRAL VALVE REPLACEMENT AND CORONARY ARTERY GRAFTING. PRE-OP, SHE WAS TAKING DIGOXIN, FUROSEMIDE, ISOSORB ET AL. POST-OP THE TRANSFUSION SHE WAS TAKING NEOSYNEPHRINE AND DOPAMINE AND OTHER. A TRANSFUSION OF PACKED RED CELLS WAS ADMINISTERED THROUGH THE CENTRAL LINE IN PLACE. A DECREASE IN SYSTOLIC PRESSURE FROM 120 MMHG TO 45 MMHG WAS REPORTED. THE PATIENT WAS NOT REPORTED TO HAVE SUFFERED ANY LASTING EFFECTS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. THE SURGEON WAS PERFORMING HIS FIRST PROCEDURE OF THIS TYPE. THE SURGEON REMOVED THE DEVICE THROUGH THE PORT REPEATEDLY WITH THE INSTRUMENT IN THE ARTICULATED POSITION. THE SURGEON RELOADED THE DISPOSABLE LOADING UNIT. DIFFICULTY WAS EXPERIENCED INSERTING THE INSTRUMENT THROUGH THE PORT AND EXCESSIVE FORCE WAS USED TO GET THE INSTRUMENT THROUGH THE DISTAL END OF THE PORT. SUBSEQUENTLY, UPON FIRING, THE CARTRIDGE BECAME DISLODGED AND THE STAPLES FELL OUT OF THE CARTRIDGE. THE PIECES WERE RETRIEVED LAPAROSCOPICALLY. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
9/20/96-INITIAL REPORT SENT TO FDA BY MFG.
PER THE INFO PROVIDED TO CO THE HOSP, THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION". THE MFR'S RECORDS REVEAL THAT THE PT WAS INITIALLY IMPLANTED ON 3/4/91. A REVISION OCCURRED ON 12/2/92 (CO FILE #92-0672, REPORTED TO THE FDA THROUGH MEANS OF MEDICAL DEVICE REPORT ACCESS#: M359134), WHEREBY THE PUMP AND CYLINDER SET ONLY WERE REMOVED AND REPLACED. UPON RECEIPT OF THE EXPLANTED PROSTHESIS FROM THE HOSP, THE PUMP AND CYLINDER(S) ONLY WERE RETURNED. THIS WOULD INDICATE TO THE MFR THAT THE RESERVOIR COMPONENT, IMPLANTED ON 3/4/91; REMAINS INPLACE.
IN A RETURNED QUESTIONNAIRE, THE MD INDICATED THE FOLLOWING: THE MALFUNCTION IS REPORTED AS "TUBE BROKEN AT PUMP," AT IMPLANT THE MD OBSERVED BROKEN TUBING, THERE WERE NOT ANY APPARENT CIRCUMSTANCES NOTED THAT MAY HAVE CONTRIBUTED TO THIS OCCURRENCE, THERE WAS NO ANY INFO APPARENT IN THE PT'S HISTORY WHICH MAY HAVE CONTRIBUTED TO THIS OCCURRENCE, THIS MD DID NOT PERFORM THE ORIGINAL IMPLANT, THE DEVICE WORKED UNTIL THE MD SAW THE PT, AS FAR AS THE MD KNEW THE PT USED THE DEVICE AS INSTRUCTED, THIS DEVICE WAS NOT DAMAGED DURING THE EXPLANT SURGERY. ADDITIONALLY THE MD WROTE,"NOTE THAT TUBING HAD BROKEN FROM THE PUMP. I DID NOT DO THE ORIGINAL IMPLANT AND NOT SEEN THE PT TILL IT MALFUNCTIONED." TWO CYLINDERS AND THE PUMP WERE RECEIVED AND EVALUATED BY THE MFR. THE RESERVOIR AND CONNECTOR WAS NOT RECEIVED. AN OBVIOUS ANOMALY/LEAKAGE SITE EXISTED AT THE SERIALIZED STRAIN RELIEF OF THE PUMP. LEAKAGE SITES WERE ALSO OBSERVED IN EACH OF THE CYLINDER BLADDERS. MICROSCOPIC EXAMINATION OF THE LEAKAGE SITES WAS PERFORMED. THE CROSS SECTIONAL SURFACES OF THE PUMP'S SERIALIZED OUTLET WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. THE CYLINDER LEAKGE SITES SHOWED BLADDER MATERIAL THAT WAS DISCOLORED BROWN, HAD MISSING OR MOVED MATERIAL, AND APPEARED MELTED, SUGGESTING THE CYLINDERS CONTACTED A HOT INSTRUMENTS, SUCH AS A ELECTROCAUTERY UNIT. BASED ON THE RECEIVED INFO AND QA'S EVAL, QA CONCLUDES THAT THREE AREAS OF LEAKAGE EXISTED WITH THIS DEVICE. BASED ON THE DURATION OF IMPLANT, THE APPARENT HOT INSTRUMENT DAMAGE OCCURRED DURING OR SUBSEQUENT TO EXPLANT SURGERY, AND THEREFORE ARE NOT RELATED TO THE PT'S COMPLAINT. THE TUBING TEAR AT THE PUMP'S SERIALIZED OUTLET WAS CAUSED BY STRESS(ES) EXPERIENCED BY THE DEVICE WHILE INVIVO, AND WAS THE CAUSE OF THE REPORTED MALFUNCTION.
DURING SURGERY FOR SMALL BOWEL OBSTRUCTION, STAPLES FROM THE PREVIOUS VENTRAL HERNIORRHAPHY WERE REMOVED. UPON REMOVING THE STAPLES, SOME SEROUS-LIKE FLUID CAME OUT, APPROX 10 CC. FURTHER OPENING OF THE WOUND IDENTIFIED A LOOP OR KNUCKLE OF SMALL BOWEL THAT WAS INCARCERATED AND NEAR STRANGULATED IN THE OPENING FROM THE VENTRAL HERNIA REPAIR. THE MESH THAT WAS THERE WAS INTACT, AS WERE ALL OF THE SUTURES EXCEPT FOR THE CEPHALAD TWO SUTURES WHICH HAD BROKEN. THE TIES WERE IN PLACE BUT THE TWO SUTURES HAD BROKEN, AND THROUGH THIS APPROXIMATELY 2 CM OPENING, A LOOP OF SMALL BOWEL HERNIATED THROUGH AND APPROXIMATELY 8 TO 10 CM OF KNUCKLE OF BOWEL WERE HERNIATED THROUGH THIS OPENING. IN RECOVERY, AS THE PT WAS WAKING UP FROM ANESTHESIA, THE SCRUB NURSE COULD FEEL A SUTURE POP UNDERNEATH THE INCISION. FOR THAT REASON, THE PT WAS CONTINUED ON ANESTHESIA. HE WAS ALREADY EXTUBATED, SO THE ANESTHETIST CONTINUED WITH MASK ANESTHESIA. AT THIS POINT THE PT WAS RE-PREPPED AND DRAPED IN A STERILE MANNER AND THEN THE SUTURES WERE REMOVED. AFTER THE INCISION WAS OPENED AND RETRACTED, THE MESH WAS RELEASED ON ONE SIDE AND FOLDED OVER. IT WAS IDENTIFIED IN THE MIDDLE OF THE REPAIR, ONE OF THE SUTURES HAD BROKEN. A FIGURE-EIGHT MESH WAS THEN REATTACHED ON ITS ONE SIDE USING INTERRUPTED SUTURES. THE SKIN WAS REAPPROXIMATED USING STAPLES. THE PT TOLERATED THAT PORTION OF THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO "LACK OF FLUID IN DEVICE", SECONDARY TO "FAILURE". AS REPORTED TO CO THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MFR'S DEVICE. 10/18/96 UPON RECEIPT OF THE PHYSICIAN/SURGEONS OPERATIVE REPORT IT WAS STATED, "THE CYLINDERS WERE REMOVED THROUGH INCISIONS IN THE TUNICA. A LEAKING POINT COULD NOT BE DEFINITELY IDENTIFIED, BUT THE CYLINDERS WERE FULL OF AIR. THE PUMP WAS ALSO REMOVED THROUGH THE SAME INCISION". THE MFR IS IN RECEIPT OF THE CYLINDERS AND PUMP COMPONENTS FROM THE INITIAL IMPLANT ON 5/4/90 HOWEVER, THE RESERVOIR COMPONENT WAS NOT RETURNED. IT IS NOT KNOWN IF THE RESERVOIR WAS LEFT IMPLACE; THE OPERATIVE REPORT DID NOT REFER TO ITS REMOVAL. FURTHER INQUIRES ARE BEING MADE TO THE PHYSICIAN/SURGEON'S OFFICE REGARDING THE DISPOSITION OF THIS DEVICE COMPONENT. ADD'L SERIAL #: 012487. ADD'L LOT #: 012499.
THE RECIEVED OPERATIVE REPORTS STATES THAT, " A LEAKING POINT COULD NOT BE DEFINITELY IDENTIFIED, BUT THE CYLINDERS WERE FULL OF AIR." ADDITIONALLY, THE REPORT NOTES THAT TWO CYLINDERS AND THE PUMP WERE REMOVED, BUT THE RESERVOIR WAS NOT EXPLANTED. THE TWO CYLINDERS AND THE PUMP WERE RECEIVED AND EVALUATED BY THE MFR. NO CONNECTORS WERE RECEIVED. DURING FUNCTIONAL TESTING NO LEAKAGE SITE WAS OBSERVED. MICROSCOPIC EXAMINATION WAS PERFORMED. MONOFILAMENT WAS OBSERVED TO BE PROTRUDING THROUGH THE OUTER TUBING LAYER OF THE SERIALIZED OUTLET. A PORTION OF MONOFILAMENT WAS ALSO PROTRUDING THROUGH THE OUTER TUBING LAYER OF ONE OF THE CYLINDERS. IT WAS UNDETERMINED IF THE INNER LAYERS OF TUBING LAYER OF ONE OF THE CYLINDERS. IT WAS UNDETERMINED IF THE INNER LAYERS OF TUBING WERE ALSO COMPROMISED. THE CYLINDER TUBING ENDS DID NOT MATCH-UP WITH THE PUMP TUBING ENDS. THUS, A PORTION OF TUBING BETWEEN THE PUMP AND EACH CYLINDER WAS NOT RECEIVED. BASED ON DEVICE HISTORY RECORDS, THESE PORTIONS OF TUBING CONTAINED TRUE-LOCK CONNECTORS. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCE'S EVALUATION, QA CONCLUDES THAT THE TWO ABOVE AREAS OF DAMAGE MAY HAVE CAUSED A LEAK WHILE THE DEVICE WAS IN-VIVO. HOWEVER, QA CAN NOT CONCLUSIVELY SHOW THAT THESE TWO AREAS ARE LEAKAGE SITES. FURTHER, SINCE THE PORTIONS OF TUBING WITH CONNECTORS NOR THE RESERVOIR WERE RECEIVED BY THE MFR, QA IS PRECLUDED FROM COMMENTING ON THE STATUS OF THOSE COMPONENTS.
THE NOTCH ON A TIBIAL STEM WAS NOT MANUFACTURED IN THE CORRECT POSITION.
CONCLUSION STATEMENT: ISOLATED MANUFACTURING ERROR. SYSTEM CHANGES IMPLEMENTED TO PREVENT RECURRENCE. INCIDENT OCCURRED AT FOREIGN USER FACILITY. THEREFORE, NO MEDWATCH 3500 A INFO RECEIVED.
THE DEVICE WAS USED DURING A COLECTOMY PROCEDURE. DIFFICULTY WAS EXPERIENCED REMOVING THE DEVICE FROM TISSUE AFTER FIRING. THE DEVICE WAS MANIPULATED FROM TISSUE WITHOUT PT INJURY. THE STAPLE LINE WAS COMPLETE.
9/20/96-MEDWATCH REPORT NOT RECEIVED FROM USER FACILITY. MFG. SUBMITTED INITIAL REPORT TO FDA.
ABOUT 10PM PT BECAME INCREASINGLY DIAPHORETIC, CLAMMY, BP 70/50, VERY PALE, UNRESPONSIVE. RECEIVED A BOLUS OF IV FLUIDS, RECEIVED 7 UNITS OF BLOOD AND PLASMA. PT RETURNED TO OR. FOUND ARTERIAL CLIPS FREE IN ABDOMINAL CAVITY.
SURGEON APPLIED STAPLER TO BOWEL IN A LOW ANTERIOR RESECTION. ACCORDING TO SURGEON, THE STAPLER DID NOT HAVE STAPLES. THE SURGEON THEN USED ANOTHER INSTRUMENT WITHOUT ANY PROBLEM.
THE REPORTED CONDITION COULD NOT BE CONFIRMED AS EVIDENCE WAS FOUND THAT INDICATED STAPLES WERE PRESENT. HOWEVER, DURING INVESTIGATION THE INSTRUMENT LOCKED. ANALYSIS OF THIS CONDITION REVEALED THAT THE DISTAL END OF THE "#2 LATCHING ROD" LIFTED AND BECAME DISENGAGED FROM THE SUPPORT BLOCK. INTERMITTENTLY, DURING APPROXIMATION OF THE INSTRUMENT, THE LATCH CAM ADVANCED THE ROD SLIGHTLY FORWARD WHICH RESULTED IN BINDING OF THE ROD BETWEEN THE CAM BRIDGE AND THE SUPPORT BLOCK. THIS INTERMITTENT BINDING PREVENTED THE INSTRUMENT FROM OPENING UPON ACTIVATION OF THE APPROXIMATING BUTTON. AS CORRECTIVE ACTION, PROCESS MODIFICATIONS WERE IMPLEMENTED TO MECHANICALLY PREVENT THE ROD FROM LIFTING AND ELIMINATE FURTHER OCCURRENCE OF THIS CONDITION.
THE REPORT INDICATED THAT DEVICE WAS STARTED ON 9/28/96 ON A 44-YEAR OLD MALE RESCUED FROM DROWNING. SERIAL NOS 1550472 AND 1550473 WERE CHANGED OUT AFTER 21 HOURS OF USE FOR PLASMA BREAKTHROUGH. A THIRD OXYGENATOR WAS CHANGED OUT AFTER 21 HOURS OF USE FOR PLASMA BREAKTHROUGH. A THIRD OXYGENATOR WAS CHANGED OUT AFTER 24 HOURS OF USE (S/N 1550471) WHEN PLASMA BREAKTHROUGH WAS OBSERVED. ECMO IS AN OFF LABELED USE OF THE DEVICE. THE DEVICE IS DESIGNED AND LABELED TO OPERATE FOR A MAXIMUM PERIOD OF 6 HOURS. INFO WAS RECEIVED THAT THE PT EXPIRED; HOWEVER, THIS WAS NOT RELATED TO THE OXYGENATOR CHANGE-OUTS. ONLY S/N 1550471 WAS RECEIVED FOR COMPLAINT EVALUATION.
DISCLAIMER STATEMENT: THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSION OF MEDTRONIC CARDIOPULMONARY DIVISION, ITS OFFICERS, EMPLOYEES, OR AGENTS. ONE OXYGENATOR (SERIAL NUMBER 1550471) WAS RECEIVED FOR COMPLAINT ANALYSIS ON 11/4/96. THE RETURNED DEVICE WAS SET-UP IN A SIMULATED CIRCUIT FOR TESTING UNDER THE OBSERVATION OF A TECHNICIAN. THE UNIT WAS OBSERVED IN THE PERFUSION CIRCUIT FOR A PERIOD OF 6 HOURS WHICH SUPORTS CO'S LABELED DURATION OF USE. NO PLASMA BREAKTHROUGH WAS OBSERVED DURING THIS TIME PERIOD. IN SUMMARY, THE REPORTED COMPLAINT COULD NOT BE DUPLICATED IN CO'S LABORATORY SETTING.
PT DISLOCATED TOTAL KNEE AND WAS HAVING KNEE PAIN. DR REPLACED TIBIAL INSERT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, A COMPONENT DISENGAGED INTO THE PT'S CAVITY. THE PIECE WAS RETRIEVED LAPAROSCOPICALLY WITHOUT INCIDENT. THE SURGEON COMPLETED THE  PROCEDURE WITH THE SAME INSTRUMENT.
HYPOGLYCEMIC REACTION: BREATHING DIFFICULT: A WOMAN REPORTED THAT FOUR WEEKS AFTER HER MOTHER STARTED USING A DEVICE WITH NOVOLIN N (RDNA) PENFILL INSULIN, SHE EXPERIENCED DIFFICULTY IN BREATHING AND WAS HOSPITALIZED. SHE STATED THAT HER MOTHER'S BLOOD GLUCOSE LEVEL WAS 34 MG/DL ON ADMISSION TO THE HOSP. SHE WAS TREATED AND DISCHARGED FOUR DAYS LATER AND HER INSULIN DOSE WAS DECREASED BY 10 UNITS DAILY. ALTHOUGH THE DEVICE PASSED THE FUNCTION CHECK, THE DAUGHTER FEELS THAT THE DEVICE MAY HAVE DELIVERED MORE INSULIN THAN THE REQUIRED DOSE. NO INFO CONCERNING THE PT OR THE EVENT HAS BEEN RECEIVED FROM THE PT'S PHYSICIAN. ANALYSIS OF THE SUSPECT DEVICE DID NOT REVEAL ANY FAULTS. THE DEVICE PASSED A WEIGHT ACCURACY TEST.
IS THE EVENT LISTED IN INSERT? NO. IS THE EVENT OCCURRING MORE FREQUENTLY? NO. IS THE EVENT'S SEVERITY LISTED IN INSERT? NO. IS THE SEVERITY OCCURRING MORE FREQUENTLY? NO.
IT WAS REPORTED A BALLOON DEVELOPED A PIN-HOLE LEAK DURING PREPARATION VIA HAND INFLATION FOR A PERIPHERAL ANGIOPLASTY. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. WITHOUT EVALUATING THE PRODUCT, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO DIRECTIONS FOR USE STATE: "AS SUPPLIED THE BALLOON LUMEN OF THE BALLOON DILATATION CATHETER CONTAINS AIR. THIS AIR MUST BE DISPLACED TO MAKE CERTAIN THAT ONLY LIQUID FILLS THE BALLOON WHILE THE CATHETER IS IN THE BLOODSTREAM. TO DISPLACE AIR INJECT JUST ENOUGH CONTRAST MIXTURE TO PARTIALLY INFLATE THE BALLOON. TO MAKE CERTAIN THAT ALL AIR IS REMOVED FROM THE BALLOON, REPEAT".
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON THE INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
REPORT OF ALLEGED "CONTINOUS CYCLE, NO VOLUME DELIVERED, WITH AUDIABLE AND VISUAL ALARMS. FOUND DURING TESTING.
UNABLE TO OBTAIN ALL INFORMATION REQUIRED IN SECTION F. TESTING BY MFR FOUND A CONTINOUS CYCLE, NO VOLUME DELIVERED, WITH AUDIABLE AND VISUAL ALARMS, DUE TO MAGNETIC SENSOR BEING OUT OF SPECIFICATION. REPLACED MAGNETIC SENSOR. LABELING-#1738
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT. THE HOSPITAL DID NOT PROVIDE ANY FURTHER INFO.
12/17/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D7, D8 AND D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
PT BROUGHT TO ER VIA AMBULANCE, IN ASYSTOLE. NURSE'S ASSESSMENT SHOWED NO PACEMAKER RHYTHM NOTED, BUT MD NOTED PACEMAKER WAS NOT CAPTURING ON ARRIVAL TO ER. CPR UNSUCCESSFUL.
WHEN SETTING UP THE PUMP FOR THE NEXT PT, FREEFLOW WAS OBSERVED. THE PUMP WAS NOT CONNECTED TO A PT.
THE PUMP WAS SENT IN FOR ROUTINE SERVICE. WHEN THE PUMP WAS EVALUATED IT WAS FOUND TO HAVE A BROKEN ACTUATOR. THIS TYPE OF FAILURE CAN RESULT IN A FREEFLOW SITUATION. FOLLOW-UP WITH THE HOSP INDICATED THAT THE PUMP HAD BEEN REPORTED TO HAVE FREEFLOW PRIOR TO CONNECTING TO A PT. THE ACTUATOR WAS EVALUATED AND FOUND TO HAVE A CHEMICALLY INDUCED FRACTURE. THE HOSP HAS BEEN INFORMED OF PROPER CLEANING PROCEDURES THAT CERTAIN CHEMICAL CAN ATTACK THE POLYCARBON MATERIAL THAT THE ACTUATOR IS MADE OF. THE HOSP HAS ALSO BEEN INFORMED THAT A MATERIAL CHANGE HAS BEEN MADE TO THE ACTUATOR THAT IS LESS SUSCEPTIBLE TO CHEMICAL DAMAGE AND IS NOW AVAILABLE. THIS REPORT WAS FILLED OUT BY THE MFR. NO PT WAS INVOLVED THEREFORE THERE IS NO PT INFO. MFR'S REPORT DATE: 11/1/96.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED ORTHOPEDIC PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
IT WAS REPORTED ONE BALLOON RUPTURED AT OR JUST BELOW ITS RATED BURST PRESSURE DURING AN ARTERIOVENOUS HEMODIALYSIS FISTULA GRAFT DILATATION AND ANOTHER BALLOON RUPTURED BELOW ITS RATED BURST PRESSURE DURING A SUBCLAVIAN VEIN DILATATION. OTHER BALLOON CATHETERS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICES WERE DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WAS AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. ALSO, GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TEND TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRE MUCH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. HOWEVER, WITHOUT EVALUATING THE DEVICES, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO DIRECTIONS FOR USE SAFETY: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DIALATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLON. DO NOT REINFLATE AND REMOVE CAREFULLY.
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSIONS OF THIS MEDWATCH REPORT TO THE FDA.
PT WAS ADMITTED FOR SEPTOPLASTY. A SINGLE CONDUCTIVE PAD WAS PLACED ON HIS LEFT THIGH. A WARMED IV SOLUTION BAG WAS PLACED UNDER HIS SHOULDERS FOR POSITIONING. AT THE CONCLUSION OF THE CASE, A BURNED AREA MEASURING APPROX 30 CM LENGTH X 7 CM ACROSS WAS NOTED ON THE UPPER BACK. ALL OF THE EQUIPMENT INCLUDING THE CONDUCTIVE PAD WERE REMOVED FROM THE ROOM AND CHECKED BY BIOMEDICAL ENGINEERING. ALL OF THE ELECTRICAL EQUIPMENT WAS FOUND TO BE WORKING ACCORDING TO THE MFR'S SPECS. A LARGE AMOUNT OF HAIR WAS NOTED ON THE CONDUCTIVE PAD. CONCLUSION, THE BURN WAS PROBABLY CAUSED BY A COMBINATION OF REASONS: 1) THE IV SOLUTION BAG CAUSED THE OUTER BURN CIRCLE; 2) A POSSIBLE BOVIE CONDUCTION RETURN PATH CAUSED THE INNER BURNS; AND 3) THE EQUIPMENT DID NOT ALARM BECAUSE A SINGLE CONDUCTION PAD WAS USED WHICH WILL ONLY ALARM IF THE PAD IS PULLED OUT OF THE MACHINE.
THE LEAD WAS PLACED IN THE PT IN THE CARDIAC CATH. LAB UNDER FLUOROSCOPY. APPROX. 5 HOURS AFTER INITIAL PLACEMENT THE LEAD STOPPED FUNCTIONING AND WAS REMOVED. A SECOND PACING LEAD WAS PLACED IN THE PT. THIS LEAD ALSO STOPPED FUNCTIONING AND WAS REMOVED ALONG WITH THE ANOTHER CO'S CATHETER THROUGH WHICH THE LEAD WAS PLACED AS THE PT'S CONDITION HAD IMPROVED.
THE RETURNED LEAD WAS RECEIVED ON SEPT 11TH. IT WAS PACKAGED IN A STANDARD SHIPPING ENVELOPE AND DOUBLE PLASTIC BAG. ENCLOSED WAS A NOTE FROM  AN RN DATED AUGUST 20TH WITH A SUMMARY OF THE INCIDENT. INITIAL VISUAL INSPECTION OF THE RETURNED ITEM SHOWED IT TO BE BASICALLY INTACT. THE PROXIMAL CONNECTOR WAS COVERED WITH A SYRINGE NEEDLE GUARD THAT WAS TAPED IN PLACE. THERE WAS NO EXPLANATION FOR THE USE OF THIS GUARD. THERE WAS ALSO AN OFFSET KINK APPROX. 3MM FROM THE END OF THE WIRE. THE TEMPORARY GUARD WAS REMOVED FROM THE PROXIMAL CONDUCTOR TO EVALUATE THE ELECTRICAL CHARACTERISTICS OF THE LEAD. BOTH DISTAL AND PROXIMAL CONNECTORS HAD MARKS CHARACTERISTIC OF SET SCREW CONNECTIONS APPROX. 6MM FROM THE TIPS AND 1 MM IN DIAMETER. INITIAL MEASUREMENTS OF THE LEAD INDICATE >1MOHM RESISTANCE BETWEEN THE DISTAL AND PROXIMAL LEADS. THE PROXIMAL CONDUCTOR, FROM CONNECTOR TO COIL IS CONTINUOUS READING LESS THAN 200 OHMS. THE DISTAL CONDUCTOR, CONNECTOR TO COIL (EITHER SIDE OF KINK) IS OPEN WITH A RESISTANCE OF >1MOHM. THE RESISTANCE ACROSS THE KINK IS ESSENTIALLY ZERO. WHEN THE TIP IS GENTLY FLEXED, THE FULCRUM TENDS TO BE IMMEDIATELY BELOW WHERE THE DISTAL CONDUCTOR STOPS. THESE SYMPTOMS ARE CONSISTENT WITH    FRACTURE OF THE DISTAL CONDUCTOR. THE COMPLAINT, "LOSS OF CAPTURE", MAY HAVE BEEN A RESULT OF THE LOSS OF CONTINUITY OF THE DISTAL CONDUCTOR AND FURTHER ANALYSIS IS WARRANTED.
A PT'S URINE SAMPLE WAS TESTED USING THE HCG URINE ASSAY. THE RESULT WAS NEGATIVE. A SERUM SAMPLE FROM THE PT WAS QUANTITATED AT 455 MIU/ML B-HCG(METHOD OF TESTING UNK). THE PT HAD ALSO HAD AN ULTRASOUND PRIOR TO THE ASSAY WHICH HAD CONFIRMED SHE WAS PREGNANT. AN OPENED KIT NUMBER 690604 WAS RETURNED FROM THE CUSTOMER FOR IN-HOUSE TESTING. NO SAMPLE WAS RETURNED. NEGATIVE CONTROL, POSITIVE CONTROL AND POSITIVE CONTROL DILUTIONS WERE TESTED USING BOTH THE RETURNED KIT AND AN INHOUSE KIT OF THE SAME LOT NUMBER. TESTING RESULTS WERE ACCEPTABLE. SAMPLE HCG CONCENTRATION RETURNED KIT RESULT IN-HOUSE KIT RESULT: NEGATIVE CONTROL; O MIU/ML, VISUALLY NEGATIVE, VISUALLY NEGATIVE, POSITIVE CONTROL (PC), 50 MIU/ML VISUALLY POSITIVE, VISUALLY POSITIVE, 1:2 DILUTION OF PC, 25 MIU/ML, VISUALLY POSITIVE, VISUALLY POSITIVE, 1:5 DILUTION OF PC, 10 MIU/ML, VISUALLY POSITIVE, VISUALLY POSITIVE, 1:10 DILUTION OF PC, 5 MIU/ML, VISUALLY NEGATIVE AND VISUALLY POSITIVE. THE HCG DIRECTIONAL INSERT INDICATES THAT THE ASSAY WILL DETECT A SAMPLE WITH A CONCENTRATION OF 20 MIU/ML 100% OF THE TIME, AND WILL DETECT A SAMPLE WITH A CONCENTRATION OF 10MIU/ML 70% OF THE TIME. THERE IS NO INFO PROVIDED FOR SAMPLE BELOW 10MIU/ML. BASED ON THIS INFO AND THE ABOVE RESULTS, THE KIT PERFORMANCE IS ACCEPTABLE.
THE SUBMISSIONS OF THIS MEDICAL DEVICE REPORT IS REQUIRED OF DEVICE MFRS BY 21 CFR PART 803. NEITHER THE SUBMISSIONS OF INFO BY CO PURSUANT TO THIS RULE, NOR THE PUBLIC RELEASE OF SUCH INFO, CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CONNECTION BETWEEN THE PRODUCT AND ANY DEATH OR INJURY.
0/20/96 - MEDWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
BLOOD STRIKETHROUGH WAS FOUND ON BOTH SLEEVES OF THE GOWN. THE BLOOD HAD SOAKED THROUGH TO THE SCRUBS AND SKIN ON BOTH OF THE SLEEVES. THE PT WAS KNOWN HEPATITIS C POSITIVE, BUT THERE WAS NO ADD'L MEDICATION OR BLOOD TESTING DONE TO THE EXPOSED SURGEON.
ALTHOUGH NO LOT NUMBER AND SAMPLE WERE AVAILABLE, A POLAROID PHOTOGRAPH ILLUSTRATING THE STRIKE-THROUGH WAS INCLUDED. THE PHOTOGRAPH SHOWED WHAT APPEARED TO BE FLUID STRIKE-THROUGH ON BOTH SLEEVES OF THE GOWN. IN BOTH SLEEVES THE CUFF MATERIAL WAS ALSO WET, PARTICULARLY IN THE RIGHT SLEEVE. WETTING OF THE INNER NONWOVEN LAYER WAS CONCENTRATED IN THE LOWER FOREARM AREAS OF THE SLEEVES. THE BREATHABLE IMPERVIOUS SLEEVE CONSISTS OF A NONWOVEN FABRIC LAMINATED TO A POLYEMIC FILM. THE FILM IS BREATHABLE, BUT IS IMPERVIOUS TO BULK FLUID CHALLENGES. EXTENSIVE TESTING HAS BEEN PERFORMED TO VALIDATE THE IMPERVIOUS NATURE OF THE COMPOSITE. THE SLEEVE WILL WITHSTAND FLUID CHALLENGES UNLESS IT HAS BEEN PHYSICALLY DAMAGED. IN CONSIDERATION OF THE VALIDATION WORK PERFORMED ON THE BREATHABLE IMPERVIOUS SLEEVE, CO IS UNABLE TO EXPLAIN THE PERFORMANCE OF THE GOWN IN THIS PARTICULAR SITUATION. IN THE EVENT THAT THE SURGICAL GLOVE DID NOT FULLY COVER THE GOWN CUFF, IT IS POSSIBLE THAT THE FLUID WET THE ABSORBENT CUFF AND WAS PULLED, BY CAPILLARY ACTION, INTO THE NONWOVEN MATERIAL.
LEFT BREAST IMPLANT REMOVED AND EXCHANGED. PT NOTED LEFT IMPLANT SITE WITH ASYMMETRY. LEFT NOTED TO BE LEAKING. THE DOUBLE LUMEN IMPLANT WAS RUPTURED WITH A POCKET FILLED WITH FREE GEL. THE CAPSULE WAS THIN. NO ABNORMALITIES WERE NOTED.
PRODUCT EVALUATION SUMMARY: PRODUCT WITHIN SPECIFICATION. CANNOT CONFIRM "CALIBRATION" CHANGE.
PT WITH TRAUMATIC FRACTURE WAS PLACED IN LEFT LATERAL POSITION ON FRACTURE TABLE WITH TRACTION. AT END OF PROCEDURE WHEN SURGICAL DRAPES WERE REMOVED, COUNTER TRACTION SUPPORT WAS FOUND TO BE BROKEN.
THE PHYSICIAN HAD PLACED THE GUIDEWIRE DOWN THE CORONARY ARTERY WHEN HE NOTICED THAT THE TIP WAS NOT RESPONDING TO TORQUING. THE WIRE WAS REMOVED AND FOUND TO BE "STRETCHED OUT." NO PT INJURY WAS REPORTED ASSOCIATED WITH THIS EVENT.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. DURING PROCESSING OF THS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSP OR DISTRIBUTER. THE RESULTS OF THE GUIDEWIRE ANALYSIS DETERMINED THAT THERE WAS LOSS OF INTEGRITY IN THE AREA OF THE SHAPING RIBBON. THE SCANNING ELECTRON MICROSOPY ANALYSIS DETERMINED THAT THIS WAS DUE TO TORSIONAL OVERLOADING FROM THE STRENGTH OF THE DEVICE BEING EXCEEDED. QUALITY ENGINEERING WILL CONTINUE TO MONITOR THE DEVICE FOR THIS TYUPE OF FAILURE. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPT.
ROUTINE COMPLAINT INVESTIGATION REVEALED INCORRECT CALIBRATION CODE BEING OBTAINED.  COMPLAINT ANALYSIS SHOWS THAT THIS INCORRECT CALIBRATION CODE, IF USED TO PERFORM ASSAY WITH TEST STRIPS FORM ANY REPORTED LOT, COULD RESULT IN HIGHER THAN EXPECTED RESULTS.
CANNOT CONFIRM "CAL CODE" CHANGE TESTED WITH ACTUAL TEST STRIP COULD NTO GET CODE TO CHANGE.
THE CUSTOMER REPORTED THAT THE INSTRUMENT FAILED TO ASPIRATE SAMPLES, AND NO ERROR MESSAGE WAS GENERATED. LIQUID LEVEL DETECTION WAS TURNED OFF BY THE USER VIA THE PIPETTING PROTOCOL, THEREBY DISABLING THE INSTRUMENT'S ERROR DETECTION.
A CO FIELD SERVICE ENGINEER WAS DISPATCHED TO THE USER FACILITY. THE CAUSE OF THE ERROR IS NOT DETERMINED, AS THE INSTRUMENT WAS OPERATING UNDER A PIPETTING PROTOCOL WITH LIQUID LEVEL DETECTION DISABLED. BROKEN AND DAMAGED TIP CLAMPS WERE FOUND DURING THE INVESTIGATION, BUT MAY NOT HAVE DIRECTLY CONTRIBUTED TO THE FAILURE. LABELING IS UNDER EVAL TO ASSURE THE USER HAS A CLEAR UNDERSTANDING OF THE EFFECT OF DISABLING LIQUID LEVEL DETECTION (THEREBY DISABLING ERROR DETECTION AND REPORTING CAPABILITY).
ON 8/20/96 PT ADMITTED TO HOSP FOR MEDICAL EPICONDYLE FRACTURE OF HUMERUS. ON 8/20/96 SMALL FRAGMENT PROCEDURE PERFORMED. WHILE DRILLING THE 3.5MM CANNULATED SCREW WITH THE 2.6MM CANNULATED DRILL, DRILL CONTACTED A K-WIRE AND TIP OF DRILL BROKE IN PIECES. DRILL REMOVED, BUT FRAGMENTS REMAIN IN PT.
H6 REVIEW OF PRODUCTION RECORDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE DATA INDICATES THAT ALL PRODUCTS WITHIN THIS LOT WERE MFG IN CONFORMANCE WITH ALL DESIGN REQUIREMENTS. THE DEVICES WERE RETURNED AND THE TIPS WERE BROKE. THE DEVICES WERE EVALUATED AND THEY MET SPECS. THESE DEVICES WERE MFG IN 1994.
DURING DAILY TESTING OF DEVICE, CUSTOMER REPORTED DEVICE WOULD NOT POWER UP. SERVICE REPRESENTATIVE DUPLICATED CONDITION. DEVICE WAS REPAIRED AND PROPER OPERATION CONFIRMED.
REPORTED CONDITION WAS DUPLICATED DURING INVESTIGATION OF THE DEVICE. SERVICE REPRESENTATIVE RESEATED CONNECTOR AND CONFIRMED PROPER OPERATION. CURRENT FREQUENCY AND SEVERITY DATA DO NOT INDICATE FURTHER INVESTIGATION IS REQUIRED AT THIS TIME, HOWEVER, CO WILL CONTINUE TO MONITOR.
REPORT OF ALLEGED "AFTER UNIT WAS CONNECTED TO AUTO CIGARETTE LIGHTER UNIT WOULD NOT CYCLE; AC BATTERY CHARGE LED ONLY, CONSTANT SINGLE TONE ALARM. NO PT HARM".
UNABLE TO OBTAIN ALL INFORMATION REQUIRED IN SECTION F. TESTING BY THE MFR FOUND UNIT WOULD NOT CYCLE, WITH AC LED ONLY AND CONSTANT SINGLE TONE ALARM, DUE TO INTEGRATED CIRCUIT U4 ON THE MOTOR BOARD BEING OUT OF SPECIFICATION REPLACED U4. LABELING-#1738
A CANISTER IN A CENTRIFUGE BUCKET BROKE, DAMAGING THE ROTOR, LID GASKET AND DENTING THE CENTRIFUGE LID. SPECIMENS AND BROKEN TUBE PIECES WERE EXPELLED FROM THE SPACE BETWEEN THE LID AND THE CENTRIFUGE BODY. NO INJURIES WERE ATTRIBUTED TO THIS EVENT.
EVENT FREQUENCY: IS FREQUENCY OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IF YES, IS FREQUENCY GREATER THAN LABELED? IF NO, IS FREQUENCY GREATER THAN IS USUAL? UNK. EVENT SEVERITY: IS SEVERITY OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO. IF YES, IS SEVERITY OF THIS EVENT GREATER THAN LABELED? IF NO, IS SEVERITY OF THIS EVENT GREATER THAN IS USUAL? UNK.
IMPLANTS BECAME LOOSE AFTER SEVERAL MONTHS IN THE PT. REVISION SURGERY PERFORMED 8/96 AND PT WAS REINSTRUMENTED.
TWO STENTS WERE ADVANCED SIMULTANEOUSLY USING A "KISSING TECHNIQUE" TO THE TARGET LESION SITE IN THE PTS CALCIFIED ILIAC ARTERIES.  UPON ATTEMPTED INFLATION, ONE BALLOON BURST AT APPROX. 7ATM LEAVING THE STENT PARTIALLY EXPANDED IN THE VESSEL.  THE OTHER STENT FULLY EXPANDED WITH NO DIFFICULTIES NOTED. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION AND AN ADDITIONAL BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT AT THE TARGET LESION SITE.  THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE STENT IS INDICATED FOR BILIARY PROCEDURES ONLY. THE PRODUCT EVALUATION IDENTIFIED AN AXIAL TEAR ON THE DELIVERY BALLOON. THE COMPLAINANT REPORTED THAT A "KISSING TECHNIQUE" WAS USED IN THE DELIVERY AND DEPLOYMENT OF THE TWO STENTS.  THE INFORMATION AVAILABLE TO DATE ON SIMILAR EVENTS REASONABLY SUGGESTS THAT A LOSS OF BALLOON INTEGRITY IS A POSSIBILITY WHEN PERFORMING THIS PARTICULAR PROCEDURAL TECHNIQUE ESPECIALLY IN COMBINATION WITH VESSEL CALCIFICATION.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSITED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE KNIFE BLADE DID NOT RETRACT AFTER FIRING. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
BLOOD PRESSURE AND HEART RATE DECREASED WHEN PLACED ON VENTILATOR. PT BAGGED WITH 100% OXYGEN AND MEDICINE PUSHED TO REVERSE HEART RATE. WHEN SUCCESSFUL, PT PLACED BACK ON VENTILATOR. PROBLEM REOCCURRED IN APPROX 2 MINS. PEEP REGULATION PROBLEM REPORTED TO MFR. PT HAD POSTOPERATIVE HYPOXIENCEPHALOPATHY, DIC AND RENAL FAILURE PRIOR TO DEATH.
PUMP READ "INTERNAL ERROR." NURSE LEFT THE ROOM TO GET ASSISTANCE FROM ANOTHER RN. WHEN THEY RETURNED, THE PUMP HAD EXPLODED LEAVING THE REAR SECTION STILL MOUNTED ON THE POLE. INTERNAL PARTS OF THE PUMP WERE ON THE FLOOR AND THE BATTERY WAS LEAKING. NURSE STATED THERE WAS A "BAD BURNING" SMELL WHEN THEY RETURNED TO ROOM.
EVIDENCE WAS FOUND TO SUGGEST THAT AN EXPLOSION OCCURRRED INSIDE THE INSTRUMENT. THE CAUSE OF THE EXPLOSION APPEARED TO BE A COMBINATION OF HYDROGEN GASES, CAUSED BY BATTERY OUTGASSING AND A SHORTED TRANSISTOR ON THE POWER SUPPLY BOARD. THE BATTERY EXPLODED WAS NOT VERIFIED. THE BATTERY WAS STILL INTACT, ALTHOUGH EVIDENCE OF A SEVERE LEAKAGE WAS OBSERVED. VISUAL EXAMINATION OF THE INSTRUMENT DID SUGGEST THAT AN OUTBURST OF CONSIDERABLE FORCE HAD OCCURRED. THE Q1 TRANSISTOR FROM THE POWER SUPPLY BOARD WAS FOUND LOOSE INSIDE THE INSTRUMENT AND APPEARED TO HAVE COME UNSOLDERED FROM THE BOARD. THIS EVIDENCE SUGGESTED THAT AN OUTBURST OCCURRED INSIDE THE INSTRUMENT WHICH SEPARATED THE FRONT CASE FROM THE REAR CASE. THE CAUSE OF THE OUTBURST APPEARS TO HAVE BEEN A COMBINATION OF HYDROGEN GASES, CAUSED BY BATTERY OUT GASSING, AND A SHORTED TRANSISTOR ON THE POWER SUPPLY BOARD.
AN ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S EXTERNAL ILIAC ARTERY. UPON INITIAL INFLATION ATTEMPT, THE BALLOON BURST AT 3 ATM OF PRESSURE. DURING WITHDRAWAL OF THE DELIVERY SYSTEM, THE STENT DISLODGED FROM THE BALLOON CATHETER. A CORONARY WIRE AND BALLOON WERE USED TO RELOCATE THE STENT TO THE TARGET LESION SITE. ANOTHER PERIPHERAL BALLOON CATHETER WAS USED TO SUCCESSFULLY DEPLOY THE STENT AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE P2908 BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS A TEST RESULT OUT-OF-RANGE OF THE QUALITY CONTROL SOLUTION RANGES (QUALITY CONTROL SOLUTIONS ARE SPECIFICALLY INTENDED TO VERIFY DEVICE PERFORMANCES).  ANALYSIS INDICATES THAT THIS RESULT, HAD IT BEEN OBTAINED FROM A PATIENT SAMPLE, COULD POTENTIALLY HAVE HAD AN ADVERSE CLINICAL EFFECT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC COLON RESECTION PROCEDURE. REPORTEDLY, THE APPROXIMATING LEVER WOULD NOT CLOSE THE JAWS OF THE INSTRUMENT AFTER RELOADING. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL (PRE-EXPOSURE) LOADING OF IMPLANT. THE IMPLANT WAS INADVERTANTLY EXPOSED IMPLANT AFTER 6 WKS OF INTEGRATION. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
REPORTED ALL ALLEGED "ALL LEDS ON SINGLE TONE ALARM, STOP CYCLE. NO PT HARM."
UNABLE TO OBTAIN INFORMATION REQUIRED IN SECTION F. TESTING BY MFR FOUND A MOTOR STALL WITH AUDIABLE LOW PRESSURE ALARM, DUE TO FRACTURED ROTOR. REPLACED ROTOR. LABELING-#1738.
RPTR STATED THAT CALLER FROM ACCOUNT REPORTED A CONCERN ABOUT THE ACCURACY OF THE UNIT, BASED ON A FINAL BAG WEIGHT OF 2269 GRS WHEN PROGRAMMED WEIGHT WAS 2205. THIS IS A DIFFERENCE OF 2.9% AND THE MFR'S SPEC ALLOW +/-5%. ALSO THE USER STATED THAT THE PROGRAMMED VOLUME DISPLAYS AND THE DELIVERED VOLUME DISPLAYS WERE IN AGREEMENT, BUT HE COULD NOT PROVIDE ANY DETAILS AS TO WHAT WAS PROGRAMMED AND DELIVERED FROM EACH STATION. WHEN HE WAS ADVISED NOT TO USE THE UNIT, THE USER REPLIED THEY WOULD CONTINUE TO USE THE UNIT UNTIL THE NEW UNIT ARRIVED AND WEIGH ANY BAGS ABOUT WHICH THERE WAS A QUESTION. NO PT INVOLVEMENT 10/21/96.
SECTION F COMPLETED BY THE CO. BASED ON INFO RECEIVED FROM THE RTPR. EVAL: UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
IT WAS REPORTED THE BALLOON MATERIAL DETACHED FROM THE CATHETER SHAFT UPON WITHDRAWAL OF THE BALLOON THROUGH THE SHEATH DURING A TIBIAL ANGIOPLASTY PROCEDURE. THE BALLOON MATERIAL REMAINED IN THE SHEATH AND THE SHEATH AND BALLOON MATERIAL WERE REMOVED AS A UNIT WITHOUT PT COMPLICATIONS. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL. THEREFORE, NO FAILURE ANALYSIS WAS AVAILABLE. SHOULD THE BALLOON CATHETER BE RETURNED FOR EVAL, A SUPPLEMENTAL REPORT WILL BE FORWARDED UNDER #1219544-1996-00133. CO FOLLOW UP INDICATED NO BALLOON RUPTURE OCCURRED DURING THIS PROCEDURE, HOWEVER, DURING CATHETER WITHDRAWAL, THE BALLOON MATERIAL WAS SHEARED OFF THE CATHETER SHAFT UPON WITHDRAWAL THROUGH THE INTRODUCER SHEATH. WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "IF RESISTANCE IS FELT WHEN REMOVING A GUIDWIRE THROUGH A CATHETER OR IF RESISTANCE IS FELT WHEN REMOVING A CATHETER THROUGH AN INTRODUCER SHEATH, STOP AND REMOVE THEM AS A COMPLETE UNIT TO PREVENT DAMAGE TO THE GUIDEWIRE, CATHETER OR VESSEL."
THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE INITIAL DEVICE WAS IDENTIFIED AS CATALOG NUMBER 14-707. THE ENGINEERING EVALUATION IDENTIFIED THE DEVICE AS CATALOG NUMBER 14-376, LOT NUMBER 132225 WHICH HAS BEEN CHANGED ON THE MEDWATCH. THE ENTIRE DETACHED BALLOON SEGMENT WAS RETURNED FOR EVALUATION. BOTH BONDS WERE PRESENT ON THE CATHETER SHAFT. THE BALLOON MATERIAL DISPLAYED VERY DEFINED CHATTER MARKS. CLAMP LIKE MARKS, AS WELL AS KINKS, WERE NOTED ON THE SHAFT. ONE END OF THE DETACHED BALLOON MATERIAL WAS INVERTED OVER ITSELF FOR APPROX 5MM. THE DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP EXTERNAL SOURCE, CHATTER MARKS ON THE BALLOON SURFACE WHICH CO BELIEVES MAY HAVE CONTRIBUTED TO THIS EVENT.
FRIEND STOPPED BY TO CHECK ON PT DURING THE NIGHT ON 10/23/96. FOUND PT SOUND ASLEEP WITH HEATING PAD TO FEET AND FEET IN A BOX. HEATING PAD SETTING ON HIGH TEMP. REMOVED HEATING PAD AND FOUND FEET TO BE HOT TO TOUCH, RED, SWOLLEN WITH LARGE BLISTERING TO TOES. FRIEND APPLIED SILVADENE CREAM AND COVERED WITH DRESSING. PT SEEN BY PODIATRIST NEXT AM. ORDERS TO CONTINUE WITH SILVADENE TREATMENT AND DRESSING DAILY. PT BEGAN USING HEATING PAD ON 10/21/96 AND HAS RECEIVED INSTRUCTIONS ON SAFE USE OF HEATING PADS LEFT IN THE HOME. PT HAD NEW HEATING PAD ONLY THREE DAYS.
A PHYSICIAN REPORTED A PT WITH A MULTIPLE TREATMENT HISTORY WHO WAS TREATED ON 11/4/96 INTO THE MARIONETTE LINES. DURING TREATMENT, THE NEEDLE BECAME DISLODGED FROM THE SYRINGE. THE NEEDLE REMAINED IN THE TREATMENT SITE; COLLAGEN MATERIAL LEAKED FROM THE SYRINGE ONTO THE PT'S FACE. TREATMENT WAS DISCONTINUED. NO INJURY OCCURRED TO THE PT.
THE DEVICE WAS USED DURING A HERNIA REPAIR PROCEDURE. REPORTEDLY, THE CLIPS DID NOT HOLD PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
9/20/96 - MEDWACTH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
A BALLOON RUPTURED FOLLOWING MULTIPLE INFLATIONS ABOVE ITS RATED BURST PRESSURE DURING AN ILIAC ANGIOPLASTY OF AN EXTREMELY CALCIFIED LESION VIA AN IPSILATERAL APPROACH. OTHER BALLOON CATHETERS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE WAS REC'D. EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE SHAFT UNDER THE BALLOON WAS CORKSCREWED. MICROSCOPIC EXAMINATION REVEALED A 4MM TEAR BEGINNING 10MM PROXIMAL TO THE PROXIMAL RO MARKER. SCRATCHES WERE NOTED ON THE BALLOON SURFACE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH OVERPRESSURIZATION, A CORKSCREWED SHAFT UNDER THE BALLOON, AND CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES ON THE BALLOON SURFACE. FOLLOW UP ALSO INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION AS WELL AS INFLATED BEYOND ITS RATED BURST PRESSURE. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY. THE RATED BURST PRESSURE SHOULD NOT BE EXCEEDED. INFLATION IN EXCESS OF RATED BURST PRESSURE MAY CAUSE THE BALLOON TO RUPTURE".
THE DEVICE UNDERDELIVERED. NO FURTHER INFORMATION IS AVAILABLE.
THIS MDR IS BEING FILED IN ORDER TO COMPLY WITH 21 CFR PART 803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT THE DEVICE ACTUALLY MALFUNCTIONED OR CAUSED ANY INJURY.  H 81: CO.'S INVESTIGATION IS NOT YET COMPLETE. CO. PLANS TO SUBMIT ADDITIONAL INFORMATION AT THE CONCLUSION OF ITS ANALYSIS.
ROUTINE COMPLAINT INVESTIGATION CONFIRMS A FALSELY HIGH TEST RESULT.  ANALYSIS INDICATES THAT THERE IS A POSSIBILITY THAT THIS MALFUNCTION WERE IT TO RECUR FOR CERTAIN PATIENTS UNDER CERTAIN CONDITION, COULD RESULT IN SERIOUS ADVERSE CLINICAL EFFECTS TO THE USER OF THE SYSTEM.
INVESTIGATION CONDUCTED. DR CITES SURGICAL TRAUMA AS CAUSE FOR FAILURE. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
PT HAD IMPLANT REMOVED BASED ON ASYMMETRY. PT HAD CAPSULAR CONTRACTURE OF THE RIGHT WITH OPEN CAPSULOTOMY. INFO OF THE IMPLANT WAS EXTREMELY LIMITED. PT WITH PREVIOUS MASTECTOMY OF THE RIGHT IN 1994. ALL PREVIOUS PROCEDURES WERE NOT DONE AT THIS FACILITY.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSITED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT CLOSE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.  ADDITIONAL DATA ENTERED IN D9.  DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
PT UNDERWENT AN INTRAMEDULLARY ROD INSERTION LEFT FEMUR. DURING THE INSERTION APPROX 2-3 INCHES BROKE OFF THE TIP. THIS DEVICE WAS REMOVED AND A NEW ONE WAS INSERTED. ROD IS 12MMX 38 CM. TWO FEMORAL LOCKING SCREWS WERE ALSO USED.
ON 10/4/96, THE ACCOUNT RECEIVED AN ERRATIC BHCG RESULT WHILE OPERATING THE ANALYZER. THEY RUN THE BHCG ASSAY IN SAMPLE CUPS ONLY AND PROCESS EACH SAMPLE UNDILUTED, WITH A 1:10 DILUTION, AND A 1:200 DILUTION. THE FOLLOWING RESULTS WERE RECEIVED ON A PT SAMPLE: UNDILUTED=0.0 MLU/ML (NO ERROR CODE RECEIVED); 1:10 DILUTION=<40MLU/ML (NO ERROR CODE RECEIVED); AND 1:200=12390.89ML/ML. TO CONFIRM THE 1:200 RESULT, A URINE QUALITATIVE BHCG WAS PERFORMED AND IT WAS POSITIVE. CUSTOMER STATED THE ORIGINAL RESULTS WERE NOT REPORTED. THE ACCOUNT HAS NOT PROVIDED FURTHER PT INFO. NO REPORT OF INJURY.
THE FOLLOWING INFO HAS CHANGED FROM THI INITIAL REPORT AND APPLIES TO THE DEVICE EVALUATION: SECTIONS D1, D2, D3, D5, D6 AND H4.
REPORTED OF ALLEGED "NO ALARM PRESSURE ALARM WHEN PT DISCONNECTED FROM VENTILATOR. NO PT HARM."
UNABLE TO OBTAIN ALL INFORMATION REQUIRED IN SECTION F. TESTING BY THE MFR DID NOT CONFIRM NO AUDIBLE ALARM AT DISCONNECT. ADDITIONAL TESTING FOUND A CONTINOUS CYCLE, NO VOLUME DELIVERED, WITH SETTING ERROR ALARM, DUE TO TRANSISTOR Q6 ON THE MOTOR BOARD BEING OUT OF SPECIFICATION. REPLACED Q6. THIS DID NOT RELATE TO REPORTED EVENT. LABELING-#1738
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE RED ACTIVATION BUTTON COULD NOT BE ENGAGED AND WOULD NOT STAY IN THE DOWN POSITION. A NEW DEVICE WAS PULLED FOR THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7;D6,10: INFO UNAVAILABLE. 10/11/96 1205 MESSAGE AND 800# LEFT FOR MD CALL BACK. SURGEON WILL BE BACK IN OFFICE ON MONDAY. 10/11/96 THE SURGEON'S OFFICE CALLED AND STATED THE SURGEON DID NOT WANT TO SPEAK TO THE CIN. HE STATED HE WILL CONTINUE TO USE THE PRODUCT AND THANKED US FOR THE FOLLOW-UP. NO ADD'L INFO WAS ABLE TO BE OBTAINED. BASED UPON THE INFO RECEIVED AND THE VISAUL EXAMINATION, IT WAS DETERMINED THAT THE INSTRUMENT ARMED INTERMETTENTLY. THE ENDCAP WAS DISASSEMBLED AND THE KNIFE COLLAR FOUND TO BE BENT WHICH MAY HAVE CAUSED THE REPORTED INCIDENT. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. THE ASSEMBLY LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
SUMMARY OF EVALUATION: METALLURGICAL EVALUATION REVEALED THE RETURNED ALTA ROD BROKE FROM AN OVERLOAD CONDITION. VISUAL INSPECTION SHOWS A BEND IN THE PROXIMAL SECTION OF THE ROD AT THE PROXIMAL CROSS LOCKING SCREW HOLE, SUGGESTS THAT EXCESSIVE NON-AXIAL FORCES APPLIED TO THE ROD DURING INSERTION WAS MOST LIKELY THE CONTRIBUTING FACTOR FOR THE ROD FROM AN OVERLOAD CONDITION.
A MOBILE UNIT HAD A PT IN CARDIAC ARREST, TRYING TO 'BAG' PT AND OBSERVED THEY WERE NOT GIVING THE AMOUNT OF OXYGEN NEEDED WHEN UNIT DEPRESSED. ANOTHER RESUSCITATOR WAS OBTAINED. THE SECOND RESUSCITATOR WAS OBSERVED TO HAVE THE SAME ISSUE. ANOTHER RESUSCITATOR WAS OBTAINED. PT RESUSCITATED. NO REPORTED HARM TO PT.
DURING SERVICE OF PRODUCT A MODE SWITCH ERROR WAS FOUND WITH LED ON, NO AUDIBLE ALARM SOUNDING, DUE TO FUSE F2 ON THE MOTOR BOARD BEING OUT OF SPECIFICATION. REPLACED F2.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUANTITY AS CAUSE FOR FAILURE. DR ALSO NOTES PT HAS BEEN RECENTLY DIAGNOSED WITH OSTEOMACIA. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS-(FROM BOX D6) MODEL/CATALOG # 2214/2214, LOT NUMBER 942000
THERE WAS MOTION OF THE POLYETHYLENE INSERT INSIDE THE CUP. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: EVALUATION OF THIS EVENT CANNOT BE PERFORMED BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO CO. THE DEVICE HAS BEEN IMPLANTED. DUE TO TOLERANCES REQUIRED TO MFR TO THE SHELL AND THE POLYETHYLENE INSERT, SOME TOGGLE MAY BE PRESENT BETWEEN THE COMPONENTS OF THIS DEVICE. THIS SLIGHT TOGGLE IS WITHIN FINAL INSPECTION ACCEPTABLE STANDARDS FOR THIS PRODUCT. THE DEVICE HISTORY RECORD FOR THE LOT CODE OF THE CUP THAT WAS IMPLANTED WAS REVIEWED AND NO DISCREPANCIES WERE OBSERVED.
DIFFICULT DEFLATION WAS ENCOUNTERED DURING A CORONARY ANGIOPLASTY OF A SAPHENOUS VEIN GRAFT. DILATATION WAS SUCCESSFULLY ACHIEVED AND THE BALLOON WAS REMOVED THROUGH THE INTRODUCER SHEATH WITHOUT FURTHER INCIDENT. THE PROCEDURE WAS COMPLETED SUCCESFULLY WITH THIS BALLOON WITHOUT PT COMPLICATIONS. THIS DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE NO FAILURE ANALYSIS WILL BE AVAILABLE. THIS DEVICE WAS BEING USED IN A NON-INDICATED PROCEDURE. THEREFORE, CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, WE CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "THESE CATHETERS ARE NOT DESIGNED FOR USE IN THE CORONARY ARTERIES. ANY USE FOR PROCEDURES OTHER THAN THOSE INDICATED IN THE INSTRUCTIONS IS NOT RECOMMENDED... WHEN DILATATION HAS BEEN COMPLETED, DEFLATE THE BALLOON BY APPLYING SUCTION TO THE BALLOON LUMEN... THE LARGER THE SYRINGE DIAMETER, THE GREATER THE SUCTION THAT IS APPLIED. FOR MAXIMUM DEFLATION A 20CC SYRINGE IS RECOMMENDED... IF RESISTANCE IS FELT WHEN REMOVING A GUIDEWIRE THROUGH A CATHETER OR IF RESISTANCE IS FELT WHEN REMOVING A CATHETER THROUGH AN INTRODUCER SHEATH, STOP AND REMOVE THEM AS A COMPLETE UNIT TO PREVENT DAMAGE TO THE GUIDEWIRE, CATHETER OR VESSEL."
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NO TINCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
THE PT IS "UNABLE TO INFLATE THE DEVICE WITHOUT CAUSING SEVERE PAIN AND THEREFORE, NO LONGER ABLE TO USE IT".
A CORRECTION WAS MADE TO THE SERIAL NUMBER DATA IN SECTION D-6. ACCORDING TO THE RECEIVED INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 10/20/83. ON 9/5/96 A RECEIVED COMPLAINT FROM A PATIENT REP. STATED, "[THE PATIENT] IS UNABLE TO INFLATE THE DEVICE WITHOUT CAUSING SEVERE PAIN. THEREFORE, NO LONGER ABLE TO USE IT." AT THIS TIME, THERE HAVE BEEN NO REPORTS THAT A SERIOUS INJURY, MEDICAL INTERVENTION, OR SURGICAL INTERVENTION HAS OCCURRED OR IS PENDING. THE PATIENT REP. HAS NOT PROVIDED A MEANS OF CONTINUING OUR INVESTIGATION AT THIS TIME. TO DATE, THIS COMPLAINT HAS NOT BEEN CONFIRMED TO THE MFR BY A MEDICAL PROFESSIONAL. WITHOUT INFO FROM A MEDICAL PROFESSIONAL OR AN EXPLANTED DEVICE, QUALITY ASSURANCE IS PRECLUDED FROM COMMENTING ON THIS OCCURRENCE. SHOULD ADDITIONAL INFO AND/OR THE EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND RE-EVALUATED, ACCORDING TO PROCEDURES.
DURING SERVICE OF DEVICE A MODE SWITCH ERROR WAS FOUND WITH LED ON, NO AUDIBLE ALARM SOUNDING, DUE TO FUSE F2 ON THE MOTOR BOARD BEING OUT OF SPECIFICATION. REPLACED F2.
DURING REMOVAL OF THE CATHETER FROM THE DISPENSER, THE TIP DETACHED. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT.
THE CATHETER WAS RECEIVED FOR EVAL ON 8/13/96. ANALYSIS INDICATED THAT THE TIP OF CATHETER WAS DETACHED AT MID-SHAFT. THE CATHETER WAS BROKEN APPROX 30.3CM PROXIMAL TO THE DISTAL TIP. THE REMAINING PORTION OF THE CATHETER WAS STILL INSIDE THE DISPENSER. A LONG TERM CORRECTIVE ACTION HAS BEEN INITIATED TO OBTAIN ADD'L INFO ON THE REPORTED COMPLAINT.
THE PT IS EXPERIENCING "MIGRATION, RESULTING IN CONSIDERABLE PAIN AND DISCOMFORT.
ACCORDING TO THE REC'D INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 7/20/89. ON 9/5/96 A REC'D COMPLAINT FROM A PT REP STATED, "[THE PROSTHESIS] HAS MIGRATED, RESULTING IN CONSIDERABLE PAIN AND DISCOMFORT FOR [THE PT]". AT THIS TIME, THERE HAVE BEEN NO REPORTS THAT A SERIOUS INJURY, MED INTERVENTION, OR SURGICAL INTERVENTION HAS OCCURRED OR IS PENDING. THE PT REP HAS NOT PROVIDED A MEANS OF CONTINUING OUR INVESTIGATION AT THIS TIME. IN ADDITION, TO DATE, THIS COMPLAINT HAS NOT BEEN CONFIRMED TO THE MFR BY A MED PROFESSIONAL. WITHOUT INFO FROM A MED PROFESSIONAL OR AN EXPLANTED DEVICE, QA IS PRECLUDED FROM COMMENTING ON THIS OCCURRENCE. SHOULD ADD'L INFO AND/OR THE EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND RE-EVALUATED, ACCORDING TO PROCEDURES.
PT IN SURGERY FOR EXCISION OF GRANULOMA OF THE RIGHT LACRIMAL CARNUCLE UNDER LOCAL WITH ANESTHESIA STANDBY. PHYSICIAN USING A HANDHELD CAUTERY TO ONE LAST AREA, AS HE DID THAT, A SUDDEN FLASH EMANATED UNDERNEATH THE DRAPE AND IMMEDIATELY REMOVED THE CAUTERY FROM THE AREA AND PT AT THE SAME TIME SAT UP. FIRE OCCURRED AND PT RECEIVED SECOND, AND POSSIBLY THIRD DEGREE BURNS TO THE FACE AND LEFT POSTERIOR SHOULDER, LINEAR STREAK ON CHEST, MINOR AREAS ON CHEST WHERE THE ELECTRODE (EKG) WOULD HAVE BEEN, BLISTERS ON THE HAND. PT WAS TRANSFERRED TO ANOTHER HOSP THAT HAD A BURN UNIT. TWO OTHER PHYSICIANS EXAMINED HIM PRIOR TO THE TRANSFER, ONE DID A FIBEROPTIC NASAL PHARYNGOSCOPE PRIOR TO THE TRANSFER.
THE HANDLE OF THE DEVICE BROKE DURING STONE REMOVAL AND THE PT WAS TAKEN TO SURGERY FOR REMOVAL OF THE STONE AND BASKET. THE 79 YEAR OLD MALE PT WAS TAKEN TO ICU AND WAS CONNECTED TO A VENTILATOR. THE RN STATED THAT THE DEVICE WILL NOT BE SENT FOR EVALUATION.
CO CANNOT EVALUATE POSSIBLE CAUSES OF BREAKAGE SINCE THE DEVICE WILL NOT BE RETURNED. HOWEVER, THE INSTRUCTION MANUAL FOR THE DEVICE CAUTIONS USER NOT TO USE EXCESSIVE FORCE DURING THE PROCEDURE. THE MANUAL ALSO DESCRIBES INSTRUCTIONS FOR MEDICAL PERSONNEL SHIFTING TO SURGICAL MEASURES, IF NECESSARY.
THE PT IS EXPERIENCING "FREQUENT INFECTION".
AT THIS TIME, THERE HAVE BEEN NO REC'D REPORT THAT A SERIOUS INJURY, MED INTERVENTION, OR SURGICAL INTERVENTION HAS OCCURRED OR IS PENDING. THE PT REP HAS NOT PROVIDED A MEANS OF CONTINUING OUR INVESTIGATION AT THIS TIME, TO DATE, THIS COMPLAINT HAS NOT BEEN CONFIRMED TO THE MFR BY A MED PROFESSIONAL. WITHOUT INFO FROM A MED PROFESSIONAL OR AN EXPLANTED DEVICE, QA IS PRECLUDED FROM COMMENTING ON THIS OCCURRENCE. THE MFR IS ALSO UNABLE  TO SHOW THAT THE DEVICE IN QUESTION WAS MFG BY THIS CORP. SHOULD ADD'L INFO AND/OR AN EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND RE-EVALUATED, ACCORDING TO PROCEDURES.
DURING A DIALYSIS TREATMENT, A BROKEN BLOOD PUMP ROTOR SPRING WAS FOUND. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE FACILITY HAS NOTICED BROKEN BLOOD PUMP ROTOR SPRINGS ON MACHINES DURING DIALYSIS DUE TO PRESSURE FLUCTUATIONS AND/OR DURING P M PROCEDURES. THRE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. A REVIEW OF THE CPF/DTF HISTORIES WERE NOT POSSIBLE DUE TO AN UNK SERIAL NUMBER. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT THE SPRING WAS BROKEN INTO SEVERAL PIECES. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW. THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND/OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET. IF UNDETECTED, A BROKEN ROTOR SPRING CAN RESULT IN A LESS EFFICIENT DIALYSIS FOR THE PT. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATMOSPHERIC PRESSURE. A PUNCTURE ON THE VENOUS SIDE COULD RESUILT IN BLOOD LOSS AND POSSIBLE BLOOD CONTAMINATION. THIS ALARM GENERATES A VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE ABOVE INFO INDICATES THAT THE PM FAILURES AND PRESSURE FLUCTUATIONS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATION, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS SEE FAR #960018. FAILURE CODES: F CODE SLNCL 902WR. CUSTOMER CONTACTED: YES. SALES/SVC CONTACTED BY INVESTIGATOR? TRAINING REQUIRED?. NO.
DURING RETROGRADE CYSTOSCOPY FOR STENT PLACEMENT, THE LIGHT CORD FOR THE CYSTOSCOPE BURNED THE PT. THE CORD HAD BECOME UNSHIELDED SECONDARY TO USER ERROR. 1 CM BURN WITH BLISTER.
OUT OF A BOX OF 100 INSULIN SYRINGES RPTR FOUND (1) ONE DEFECTIVE SYRINGE: NEEDLE WAS PROTRUDING THROUGH THE SIDE OF THE NEEDLE COVER.
THE PT IS EXPERIENCING "FAILURE TO INFLATE THE DEVICE".
ACCORDING TO THE REC'D INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 10/23/96. ON 9/5/96 A REC'D COMPLAINT STATED, "[THE PT] WAS IMPLANTED WITH A [PENILE PROSTHESIS] IN OCTOBER 1990. UNFORTUNATELY, THE DEVICE NOW FAILS TO INFLATE. [THE PT] HAS BEEN ADVISED TO HAVE IT REMOVED". AT THIS TIME THERE HAVE BEEN NO REC'D REPORTS THAT A SERIOUS INJURY, MED INTERVENTION OR SURGICAL INTERVENTION HAS OCCURRED. THE PT REP HAS NOT PROVIDED A MEANS OF CONTINUING OUR INVESTIGATION AT THIS TIME. TO DATE, THIS COMPLAINT HAS NOT BEEN CONFIRMED TO THE MFR BY A MED PROFESSIONAL. WITHOUT INFO FROM A MED PROFESSIONAL OR AN EXPLANTED DEVICE, QA IS PRECLUDED FROM COMMENTING ON THE STATUS OF THIS DEVICE. SHOULD ADD'L INFO AND/OR THE EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND RE-EVALUATED.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. JUST BEFORE ASSEMBLING ANVIL TO THE INSTRUMENT IN PT, THE DR NOTICED STAPLES PROTRUDING AND THOUGHT THE INSTRUMENT WAS PARTIALLY FIRED. REMOVE INSTRUMENT AND USED A NEW ONE TO COMPLETE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10 INFO NOT PROVIDED BY AFFILIATE. D5,6; H4,6; INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
WHILE PERFORMING DAILY CHECK OF DEVICE, THE DEVICE WOULD NOT SHOCK. NO REPORTED PT INVOLVEMENT. SERVICE REPRESENTATIVE REPAIRED DEVICE AND CONFIRMED PROPER OPERATION.
SERVICE REPRESENTATIVE WAS ABLE TO DUPLICATE REPORTED CONDITION. SHOCK SWITCH WAS REPLACED AND PROPER OPERATION WAS CONFIRMED. AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME, BUT WILL BE MONITORED PERIODICALLY.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY . IT WAS REPORTED THE CLIPS WERE CROSSING UPON RELEASE FROM JAW. THERE WAS NO CONSEQUENCE TO THE PT.
H6; EVALUATION CODE #400(OTHER): YEILDED JAWS. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED ANF FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
DURING ROUTINE EQUIPMENT CHECK, DEVICE WOULD NOT POWER UP. SERVICE REPRESENTATIVE REPAIRED DEVICE AND CONFIRMED PROPER OPERATION.
INVESTIGATION BY MFR WAS ABLE TO DUPLICATE REPORTED CONDITION. FUSE WAS REPLACED AND PROPER OPERATION CONFIRMED BY SERVICE REPRESENTATIVE. AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. WILL CONTINUE TO MONITOR PERIODICALLY.
THE FACILITY HAS NOTICED BROKEN BLOOD PUMP ROTOR SPRINGS ON MACHINES DURING DIALYSIS DUE TO PRESSURE FLUCTUATIONS AND/OR DURING PM PROCEDURES. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. A REVIEW OF THE CPF/DTF HISTORIES WERE NOT POSSIBLE DUE TO AN UNK SERIAL NUMBER. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THR ROTOR IT WAS NOTICED THAT THE SPRING WAS BROKEN INTO SEVERAL PIECES. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW, THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND/OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET. IF UNDETECTED, A BROKEN ROTOR SPRING CAN RESULT IN A LESS EFFICIENT DIALYSIS FOR THE PT. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATMOSPHERIC PRESSURE. A PUNCTURE ON THE VENOUS SIDE COULD RESULT IN BLOOD LOSS AND POSSIBLE BLOOD CONTAMINATION. THIS ALARM GENERATES A VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE ABOVE INFO INDICATES THAT THE PM FAILURES AND PRESSURE FLUCTUATIONS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS SEE FAR #960018. FAILURE CODES: F CODE SLNCL902WR. CUSTOMER CONTACTED: YES. SALES/SVC CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
AFTER THE GUIDEWIRE WAS WITHDRAWN FROM THE PT DURING AN ANGIOPLASTY PROCEDURE, THE PHYSICIAN OBSERVED RESIDUE ON HIS GLOVES FROM THE GUIDEWIRE. THERE WAS NO CLAIM OF INJURY RELATED TO THIS EVENT.
THE DEVICE WAS USED DURING AN APPENDECTOMY. THE STAPLE MALFORMED. SPECIMEN FOR EVALUATION WAS SENT VIA FED EX ON 10/23/96. THE SURGEON PUT SOME STITCHES TO REPAIR THE LESION AND FINISHED THE CASE WITHOUT DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,; B6,7; D10: INFO PROVIDED BY AFFILIATE. D5; H4,6,: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
DEVICE DISPLAYED PADS NOT ATTACHED DURING DAILY CHECK OF DEVICE, NO PT INVOLVEMENT. CONDITION WAS DUPLICATED. SERVICE REPRESENTATIVE REPAIRED DEVICE AND CONFIRMED PROPER OPERATION.
INVESTIGATION OF DEVICE BY MFR WAS ABLE TO REPRODUCE REPORTED CONDITION. SERVICE REPRESENTATIVE REPLACED CABLE AND CONFIRMED PROPER OPERATION. AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME, BUT WILL BE MONITORED PERIODICALLY.
THIS 13-YR-OLD OUTPATIENT RECEIVED BURNS, SECOND AND THIRD DEGREE, DURING AN MRI PROCEDURE, WHILE UNDER GENERAL ANESTHESIA. THE BURNS WERE LOCATED AT THE SITES OF THE EKG LEADS. SILVADENE CREAM WAS APPLIED AND THE PT WAS DISCHARGED. THIS PT WAS SEEN IN THE EMERGENCY DEPT ON 10/4/96, TO BE EVALUATED FOR POSSIBLE INFECTION. THERE WERE NO OBVIOUS SIGNS OF INFECTION FOUND.
HOLE IN RESERVOIR. REPLACED BY A SECOND RESERVOIR.
THE CEMENT SET PREMATURELY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME REPORTED AT THIS TIME. THE PT REFERENCED IN THIS EVENT IS CANINE.
SUMMARY OF EVALUATION: THE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS ATTRIBUTED TO FACTORS EXTERNAL TO THE PRODUCT. NO ABNORMALITIES IN THE CEMENT WERE OBSERVED. ALL TEST RESULTS WERE SATISFACTORY AND IN ACCORDANCE WITH THE REGISTERED SPEC FOR THE PRODUCT.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE IS FRACTURE-41MM PROXIMAL OF WELD SITE. THE PROXIMAL PORTION OF J STIFFENER WIRE MEASURES-46MM AND HAS MIGRATED DOWN LEAD BODY-51MM PROXIMAL OF WELD SITE. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE LEAD WAS SNIPPED OR CUT -39.5CMS PROXIMAL OF FIXATION HELIX ELECTRODE TIP, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURE.
THE IAB WAS INSERTED ON 8/7/96. THE PT HAD DIFFICULTY COMING OFF BY-PASS. ON 8/9/96, BLOOD WAS DETECTED IN THE LINE AND QUICKLY REMOVED. THE PT FAILED TO RESPOND TO INDUSTRIAL STRENGTH ADRENALINE. IT WAS REPORTED ON 8/23/96 THAT PT WAS EXTREMELY CRITICAL PRIOR TO IABP AND WOULD HAVE EXPIRED EVENTUALLY. THE BALLOON EVENT DID NOT CAUSE THE PT'S DEATH. THE PT WAS TOO CRITICAL TO HAVE ANOTHER BALLOON INSERTED. THE PT EXPIRED ON 8/12/96.
THE PRODUCT HAS BEEN PROMISED TO CO FOR EVALUATION. THIS FORM WAS COMPLETED BY MFR. THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPERANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRAION MARK IS TYPICAL OF THW PRODUCED BY CALCIFIED PLAQUE DURING IABP. DEVICE LABELLING CODE: 1738.
CAPSULECTOMY W/REMOVAL AND EXCHANGE OF IMPLANTS. SALINE IMPLANTS, BILATERALLY.
PRODUCT IS A RECHARGEABLE ELECTRIC SONIC TOOTHBRUSH. THE PRODUCT PROBLEM IS THE ABSENCE OF EPOXY POTTING COMPOUND IN THE CHARGER BASE. THE COMPOUND PROVIDES ELECTRICAL INSULATION AND HOLDS THE CHARGER PARTS TOGETHER. IN ITS ABSENCE, THERE IS A POTENTIAL FOR THE PRODUCT USER TO RECEIVE AN ELECTRIC SHOCK OR EVEN ELECTROCUTION FROM CONTACT WITH UNINSULTAED HOUSEHOLD CURRENT.
THE AFFECTED UNIT WAS MANUFACTURED IN THE PERIOD FROM 9/3/96 TO 10/30/96. CO HAS VOLUNTARILY INITIATED AN IMMEDIATE RECALL TO REPLACE THE CHARGER BASES ON UNITS MANUFACTURED DURING THIS TIME PERIOD. THIS RECALL IS BEING DIRECTED AT HEALTH CARE PROFESSIONALS, WHOLESALERS, RETAILERS AND CONSUMERS. CO HAS INITIATED MANUFACTURING AND PACKAGING PROCESS CHANGES AND INSPECTION TO PREVENT RECURRENCE OF THIS PROBLEM.
THE COIL BECAME DISCONNECTED FROM THE INTRODUCING WIRE. THERE WAS NO ELECTROLYTIC CHARGE BEING GIVEN FOR DISENGAGEMENT. COIL WAS RETRIEVED FROM LEFT INTERNAL CAROTID ARTERY AND WAS KEPT FOR FURTHER STUDY. THE VENDOR WAS NOTIFIED OF PROBLEM. NO INJURY TO PT.
REPORTER ENCOUNTERED FREQUENT POWER FAILURE MESSAGES. NO PATIENT INJURY WAS REPORTED.
PATIENT INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE.  THIS REPORT WAS MAILED IN TO FDA ON 9/20/96.  DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIRMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
AFTER IABP FOR A LONG TIME, THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING. THE IAB WAS NOT RETURNED TO CO FOR EVAL. THE IAB WAS DISCARDED BY THE FACILITY.
THE PRODUCT IN THIS EVENT EAS NOT RETURNED TO CO FOR EVAL. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED.
RUPTURED RT SILICONE BREAST IMPLANT REMOVED AND NEW IMPLANT INSERTED. PT HAD IT INSERTED 13 YRS AGO.
PT HAD TOTAL ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR SYMPTOMATIC LEIOMYOMATA UTERI DONE ON 10/10/96. ON 10/12/96 THE PHYSICIAN ATTEMPTED TO REMOVE THE #10 FLAT DRAIN AND IT FRACTURED, DISTAL END REMAINING. LAPAROTOMY FOR THE REMOVAL OF THE #10 FLAT DRAIN. THE DRAIN WAS REMOVED WITHOUT COMPLICATIONS.
PT WITH PAINFUL CAPSULAR CONTRACTURE UNDERWENT BILATERAL CAPSULECTOMIES WITH REMOVAL OF SILICONE BREAST IMPLANTS.
REPORTER ENCOUNTERED REQUENT POWER FAILURE MESSAGES.  THERE WAS NO PATIENT INJURY REPORTED.
PATIENT INFORMATION HAS BEEN REQUESTED, BUT NOT RECIEVED TO DATE.  THIS REPORT WAS MAILED IN TO FDA ON 9/20/96.  DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE PNEUMATICS ASSEMBLY SUBASSEMBLY COULD NOT BE ADJUSTED TO SPECIFICATIONS WHILE PERFORMING ROUTINE MAINTENANCE. THE PR3 PRESSURE REGULATOR WAS NOT FUNCTIONING. THERE WAS NO PT INVOLVEMENT AT ALL.
THE CUSTOMER IS A FACTORY TRAINED BIOMEDICAL TECHNICIAN. THE CO'S SERVICE MGR SENT A REPLACEMENT PRESSURE REGULATOR TO THE CUSTOMER WHO INSTALLED IT WITHOUT ANY PROBLEMS. THE COMPLAINT ANALYSIS WAS COMPLETED OVER THE PHONE WITH THE CUSTOMER. THE STOP WAS BROKEN IN AN ATTEMPT TO COMPENSATE FOR AN UNKNOWN PATIENT CIRCUIT LEAK. A STURDIER VERSION OF THIS REGULATOR IS BEING TESTED BY CO.'S ENGINEERING DEPARTMENT.  DEVICE PMA # P890057.IS FREQUENCY ADDRESSED IN LABELING? NO.IF "NO"- FREQUENCY GREATER THAN USUAL? UNK.IS SEVERITY ADDRESSED IN LABELING? NO.IF "NO" - SEVERITY GREATER THAN USUAL? UNK.
THE INSTRUMENTS WERE SHOOTING CLIPS. A THIRD INSTRUMENT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
10/10/96 1131 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/10/96 1229 SURGEON STATED THE CLIPS JUST SHOT OUT. THIS HAPPENED AFTER SOME GOOD FIRINGS WERE OBTAINED. THE CLIPS WERE RETRIEVED WITHOUT DIFFICULTY. A1,2,3,4; B6,7; D5, 10; H4: INFO UNAVAILABLE. INFO FOR D1 THOUGH D10 AND H1 THROUGH H10 IS THE SAME FOR DEVICE #2. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS OF BOTH INSTRUMENTS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENTS NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
IV NORMAL SALINE KCL INFUSED 100ML/HR. SET AT 100ML/HR RATE. 900CC'S INFUSED OVER 4 HOURS. INCREASED DRIP RATE NOTED IN FLOW CHAMBER. NO PT COMPLICATION.
THE PUMP WAS RETURNED AND VISUALLY AND FUCTIONALLY TESTED. THE PUMP WAS NOTED TO HAVE DENTS ON THE OUTSIDE CASE INDICATING THE PUMP MAY HAVE BEEN DROPPED OR RECEIVED A SEVERE IMPACT. RATE ACCURACY WAS PERFORMED AND THE PUMP FAILED MFR'S SPECIFICATIONS. FURTHER EVAL FOUND THAT THE PUMP'S MECHANISM HAD SHIFTED PREVENTING THE MECHANISM FORM COMPLETELY PINCHING OFF THE TUBING. IT IS SUSPECTED THAT THE SHIFTED MECHANISM  WAS DUE TO A SEVERE IMPACT  SUCH AS THE PUMP BEING DROPPED. THE HOSPITAL WILL BE NOTIFIED OF CO'S FINDINGS AND INFORMED THAT THEY SHOULD INSERVICE THEIR USERS TO SEND THE PUMP TO BE CHECKED BY A QUALIFIED SERVICE TECHNICIAN IF A PUMP IS DROPPED, AS REQUIRED PER CO'S DIRECTIONS FOR USE. ASLO SERVICE BULLETIN #298 ON HOW TO PERFORM THE 10PSI MECHANISM WAS MAILED TO THE BIOMEDICAL DEPARTMENT. THE PUMP WILL BE REPAIRED AND RETURNED TO THE CUSTOMER. MFR'S REPORT DATE 9/19/96.
THE INSTRUMENT WAS USED DURING A LOW ANTERIOR RESECTION. IT WAS REPORTED THE DEVICE ONLY CUT 50% OF INTERNAL LUMEN AFTER FIRING THE INSTRUMENT. IT WOULD NOT REMOVE TRANSANALLY. ANASTOMOSIS HAD TO BE COMPLETELY HAND SEWED. HOSP IS KEEPING THE PRODUCT AND WILL NOT BE RETURNING IT TO THE REP. THERE WAS NO CONSEQUENCE TO THE PT.
BASED ON THE INFORMATION RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT APPEARS AS IF THE INSTRUMENT WAS NOT FIRED THROUGH A COMPLETE FIRING STROKE. THIS IS EVIDENCED BY THE BREAKAWAY WASHER BEING RETURNED UNCUT BUT WITH A SLIGHT INDENTATION AROUND THE ENTIRE CIRCUMFERENCE. IT SHOULD BE NOTED THAT TO ENSURE THE INSTRUMENT HAS BEEN FIRED THROUGH THE COMPLETE FIRING STROKE, THE TRIGGER MUST BE FULLY ACTUATED. A TACTILE FEEDBACK WILL BE FELT WHEN THE BREAKAWAY WASHER HAS BEEN FULLY CUT. THIS WILL ENSURE PROPER FORMATION OF THE STAPLES AND A COMPLETE CUT OF THE DONUTS. THE INSTRUMENT WAS RELOADING AND FIRED. IT FIRED AND FORMED THE STAPLES AS DESIGNED AROUND THE ENTIRE STAPLE RING WITH AN ACCEPTABLE CUT ON THE TEST MEDIA AND THE BREAKAWAY WASHER. THIS INQUIRY WAS ORIGINALLY REPORTED AS AN RPO (RECORD PURPOSE ONLY). MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
SUMMARY OF EVALUATION: THE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS ATTRIBUTED TO FACTORS EXTERNAL TO THE PRODUCT. NO ABNORMALITIES IN THE CEMENT WERE OBSERVED. ALL TEST RESULTS WERE SATISFACTORILY AND IN ACCORDANCE WITH THE REGISTERED SPEC FOR THE PRODUCT.
REPORT OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
DURING A DIALYSIS TREATMENT , A BROKEN BLOOD PUMP ROTOR SPRING WAS FOUND. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE FACILITY HAS NOTICED BROKEN BLOOD PUMP ROTOR SPRINGS ON MACHINES DURING DIALYSIS DUE TO PRESSURE FLUCTATIONS AND/OR DURING PM PROCEDURES. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. A REVIEW OF THE CPF/DTF HISTORIES WERE NOT POSSIBLE DUE TO AN UNK SERIAL NUMBER. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT THE SPRING WAS BROKEN INTO SEVERAL PIECES. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW. THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET.IF UNDETECTED, A BROKEN ROTOR SPRING CAN RESULT IN A LESS EFFICIENT DIALYSIS FOR THE PT. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATMOSPHERIC PRESSURE. A PUNCTURE ON THE VENOUS SIDE COULD RESULT IN BLOOD LOSS AND POSSIBLE BLOOD CONTAMINATION. THIS ALARM GENERATES AND VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE ABOVE INFO INDICATES THAT THE PM FAILURES & PRESSURE FLUCTUATIONS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS SEE FAR #960018. CUSTOMER CONTACTED: NO. SALES SVC CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO. REPORT ATTACHED? NO. REPORT ATTACHED? NO.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLELCYSTECTOMY. THE CLIPS WERE DROPPING OUT OF THE JAWS. THE SURGEON WAS ABLE TO RETRIEVE THE 2 CLIPS FROM THE ABDOMEN. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE.
A1,2,3,4; B6,7; D10; H4: INFO UNAVAILABLE. SEE THE FOLLOWING CORRESPONDENCE LOG: 10/10/96 1110 LEFT MESSAGE AND 800# FOR MD TO CALL BACK. 10/11/96 1030 NNCL SENT. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
REPORT RECEIVED OF WIRE FRACTURE WITHOUT PROTRUSION. THE LEAD HAS NOT BEEN EXPLANTED AT THIS TIME.
THE CEMENT SET PREMATURELY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THE CLIP DROPPED. THE CASE WAS FINISHED BY USING A NEW DEVICE WITHOUT ANY DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT.
D5;H4: D5,6; H4,6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. H6; EVALUATION CODE #400(OTHER): YEILDED JAWS. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE WOULD NOT WORK. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY CO.
LEAD WAS EXPLANTED ELECTIVELY.  FAILURE ANALYSIS INDICATES THE LEAD IS FRACTURED WITHOUT PROTRUSION.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED 9MM, 36MM, 41MM PROXIMAL OF WELD SITE.  THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 47MM AND HAS MIGRATED DOWN LEAD BODY 53MM PROXIMAL OF WELD SITE.  IT APPEARS THAT THE ENTIRE LENGTH OF THE J STIFFENER WIRE WAS RECEIVED WTIH RECORDED MEASUREMENT ADDING UP TO 88MM.  VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO THE SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURES.
WHEN RUNNING A SAMPLE ON THE DEVICE, IN THE MANUAL ORDAC (OUT OF RANGE DETECTION AND CORRECTION) MODE, A GLUCOSE RESULT WAS OBTAINED THAT WAS 1/2 OF THE ACTUAL VALUE. THE CUSTOMER REPORT WAS CONFIRMED AND IT WAS NOTED THAT A BUN RESULT COULD ALSO BE AFFECTED, HOWEVER A SPECIFIC SEQUENCE OF SYSTEM EVENTS AND TEST REQUESTS WERE REQUIRED TO SEE THIS RESULT ANOMALY IN THE GLUCOSE AND/OR BUN RESULT. NO INJURIES HAVE BEEN ATTRIBUTED TO THIS EVENT.
EVENT FREQUENCY: US FREQUENCY IOF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO IF NO, IS FREQUENCY GREATER THAN IS USUAL? UNK EVENT SEVERITY: IS SEVERITY OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? NO IF NO, IS SEVERITY OF THIS EVENT GREATER THAN IS USUAL? UNK. H3 REPORTED EVENT HAS BEEN DUPLICATED IN-HOUSE USING AN INSTRUMENT OF THE SAME MODEL AND S/W.
THE VIALS OF MONOMETER BROKE WHILE BEING OPENED FOR MIXING. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
SUMMARY OF EVALUATION: EVAL RESULTS INDICATED THAT THE COMPLAINT COULD NOT BE DUPLICATED. IT IS BELIEVED THAT THIS EVENT IS NOT DEVICE RELATED BUT IS ATTRIBUTED TO TECHNIQUE.
X-TUBE ASSM 17" X 16" DEALER CLAIMS X-TUBE BROKE WHILE SITTING IN CHAIR.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE SURGEON TRIED TO FORM CLIPS AROUND DUCT OR ARTERY AND THE CLIPS EITHER MALFORMED OR SPIT OUT. 10/16/96 IT WAS REPORTED ALL THE CLIPS WERE RETREIEVED FROM THE ABDOMEN. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE.
H6: CODE 200: DEVICE RETURNED EMPTY. CODE 400: YIELDED JAWS. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS OF BOTH INTRUMENTS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENTS NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INTRUMENT IS EVALUATED DURING THE ASSEBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUUOUSLY IMPROVE THE PRODUCTS.
DURING A DIALYSIS TREATMENT A FOUR POSITION LINE CLAMP BROKE. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. A REVIEW OF THE CPF/DTF HISTORIES WAS NOT POSSIBLE DUE TO AN UNK SERIAL NUMBER. THE RETURNED FOUR POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT THE CLAMP HOLDER WAS BROKEN. THE TABS ON THE WHITE CLAMP INSERT HOLDER WAS BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND /OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS SEE FAR #960027. CUSTOMER CONTACTED NO. SALES SVC CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO. REPORT ATTACHED? NO.
THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE SURGEON USED TOWEL CLIPS AT THE UMBILICUS TO ELEVATE THE ABDOMINAL WALL AS HE TRIED TO INSERT THE DEVICE. THE SAFETY SHIELD WOULD NOT RETRACT AND THE TOWEL CLIPS TORE THE SKIN AS HE TRIED TO INSERT THE TROCAR. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND WORKED FINE. THE SURGEON SUTURED THE SKIN TEARS AND STATED POST-OPERATIVELY THE INCISIONS HEALED WELL.
10/14/96 1034 WAS ASKED TO CALL BACK TOMORROW. THE SURGEON IS OUT OF THE OFFICE TODAY. 10/17/96 1034 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/17/96 THE SURGEON RETURNED CALL AND CONFIRMED THE INFO AS REPORTED BY THE SALES REP. HE DID STATE HE INSUFFLATED WITH A VERRES NEEDLE FIRST BEFORE ATTEMPTING TO INSERT THE TROCAR. HE WAS NOT ABLE TO TELL IF THE SAFETY SHIELD DID NOT RETRACT OR IF THE TROCAR DID NOT ARM. HE STATED IT REQUIRED A LOT FORCE TO PENETRATE. THE SURGEON HAS BEEN USING CO'S TROCARS FOR THE PAST FOUR YRS AND HAS NOT ENCOUNTERED THIS HIGH FORCE TO PENETRATE. A1,2,3,4;B6,7;D10; INFO UNAVAILABLE. D5,6;H4,8: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
QR AXLE W/NUT. DEALER CLAIMS AXLE BROKE ON INSIDE AND THE BALLS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OF INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT  SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT WAS WALKING WITH WALKER AND FELL. FRACTURED HIP RESULTED. UNSURE OF REASON FOR FALL. DID FIND WALKER BENT AND SINCE POST FALL IT DOES NOT SET LEVEL ON THE FLOOR.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLELCYSTECTOMY. IT WAS REPORTED THE CLIPS FROM A DEVICE WERE FALLING OUT OF THE JAWS. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
10/14/96 1444 WAS ASKED TO CALL BACK AT 1630 (WA TIME) TO SPEAK TO SURGEON. 10/14/96 1945 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/15/96 NNCL SENT. A1,2,3,4; B6,7; D10; H4: INFO UNAVAILABLE. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
PT PRESENTED TO ER ON 10/20/96 STATING ARM WAS BRUISED ON 10/15/96 WHEN SHE HAD BLOOD PRESSURE TAKEN. PHYSICIAN EXAMINED AND DETERMINED THAT A SOFT TISSUE INJURY HAD OCCURRED.
QR AXLE MAG W.NUT. DEALER CLAIMS BALL BEARINGS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETURN DETENT BALL. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC., OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEED, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THIS ENTIRE FORM COMPLETED BY THE MFR. THIS EXAM IS AGAIN COMPRISED OF FRONTAL VIEW OF THE CHEST AND FOUR SPOT VIEWS DURING FLUOROSCOPY. THERE IS AN ABNORMAL CONTOUR TO THE POLYURETHANE SHEATH 2 TO 3 CM PROXIMAL TO CATHODE METAL TIP OF THE ATRIAL PACEMAKER LEAD. THEREFORE, A FRACTURE IS SUSPECTED BUT THERE IS NO PROTRUSION OF THE WIRE SEGMENT THROUGH THE OUTER POLYURETHETHANE SHEATH. THERE IS ALSO ABNORMAL PIVOTING DURING FLUOROSCOPY AT THIS LEVEL. FRONTAL VIEW OF THE CHEST WHEN COMPARED TO 15 FEB 1996 HAS NOT CHANGED. THE LUNGS REMAIN CLEAR. IMPRESSION: FRACTURE SUSPECTED DUE TO CONTOUR ABNORMALITY OF THE POLYURETHANE SHEATH BUT NO PROTRUSION OF THE WIRE SEGMENT THROUGH THAT SHEATH.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE GASKET FROM THE DEVICE WAS FOUND IN THE PT'S ABDOMEN AND WAS RETRIEVED LAPAROSCOPICALLY. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D6,10: INFO UNAVAILABLE. 10/11/96 1202 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/11/96 1515 NNCL SENT. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT'S INNER GASKET HAD BECOME DETACHED DURING SURGERY. THE GASKET WAS RECEIVED IN A SEPARATE BAG. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. THE ASSEMBLY LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CLIPS FROM THE DEVICE WERE SCISSORING. A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
D5;H4: INFORMATION UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION. H6; EVALUATION CODE #400(OTHER): YEILDED JAWS. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES LEAD WAS CUT OR SNIPPED APPROX. 18CM DISTAL OF PROXIMAL TERMINAL PIN, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF THE LEAD CONFIRMS NO PORTION OF THE J STIFFENER WIRE WAS RECEIVED AND CONFIRMS NO COIL WIRE FRACTURE. PARTIAL CONDITION IS THE RESULT OF SNIPPING OR CUTTING.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. DEVICE ANALYSIS IS PROVIDED.
THE DEVICE ALARMED BUT NO VISUAL ALARM WAS INDICATED. THE VENTILATORWAS ON A PT WHO WAS SWITCHED TO ANOTHER VENTILATOR. THE PT WAS NOT COMPROMISED.
THE CUSTOMER IS A FACTORY TRAINED BIOMEDICAL TECHNICIAN. THE CO.'S SERVICE MGR DETERMINED THAT THE "OSC STOPPED" LED HAD BURNED OUT OR HAD A BROKEN CONNECTION. THE CUSTOMER REPLACED THE LED AND THE VENTILATOR WORKED FINE.   THIS COMPLAINT ANALYSIS WAS COMPLETED OVER THE PHONE WITH THE CUSTOMER.     DEVICE PMA# P890057IS FREQUENCY ADDRESSED IN LABELING? NO.IF "NO"- FREQUENCY GREATER THAN USUAL? UNK.IS SEVERITY ADDRESSED IN LABELING? NOIF "NO"- SEVERITY GREATER THAN USUAL? UNK.
QR AXLE MAG W/NUT. DEALERS CLAIMS AXLE BALLS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE FACILITY HAS NOTICED BROKEN BLOOD PUMP ROTOR SPRINGS ON MACHINES DURING DIALYSIS DUE TO PRESSURE FLUCTUATIONS AND/OR DURING PM PROCEDURES. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. A REVIEW OF THE CPF/DTF HISTORIES WERE NOT POSSIBLE DUE TO AN UNK SERIAL NUMBER. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT THE SPRING WAS BROKEN INTO SEVERAL PIECES. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW. THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND/OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET. IF UNDETECTED, A BROKEN ROTOR SPRING CAN RESULT IN A LESS EFFICENT DIALYSIS FOR THE PT. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATMOSPHERIC PRESSURE. A PUNCTURE ON THE VENOUS SIDE COULD RESULT IN BLOOD LOSS AND POSSIBLE BLOOD CONTAMINATION. THIS ALARM GENERATES A VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE ABOVE INFO INDICATES THAT THE PM FAILURES AND PRESSURE FLUCTUATIONS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS SEE FAR #960018. FAILURE CODES: F CODE SLNCC902UR. CUSTOMER CONTACTED: YES. SALES SVC CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
QR AXLE W/NUT. DEALER CLAIMS THAT THE AXLE WILL NOT LOCK INTO PLACE. THE CONSUMER FELL OUT HER CHAIR ON A GRASSY AREA. NO INJURY OCCURRED.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC UNDER 21CFR OART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WHILE RADIOLOGIST WAS TILTING TABLE, NEAR 45 DEGREES MAIN DRIVE CHAIN FROM GEAR REDUCER SNAPPED AND TABLE FELL GOING PAST HORIZONTAL THEN RETURNING TO REST AT HORIZONTAL. PT ON TABLE FELL OFF. NO APPARENT INJURY BUT SENT TO HOSP FOR CONFIRMATION.
ON TUESDAY 10/23RD, A TABLE IN MEDICAL CTE MALFUNCITONED. THE MAIN DRIVE CHAIN WAS BROKEN WHILE TABLE WAS AT 45 DEGREES, AND TABLE RAPIDLY RETURNED BACK TO 0 DEGREES. CO WAS NOTIFIED, THAT A PT POSITIONED ON THE TABLE HAD NO APPARENT INJURIES, BUT WAS SENT TO HOSP FOR CONFIRMATION AND WAS RELEASED. THIS TABLE HAS A MODEL NO 6806.101 AND SERIAL NO 904505, AND WAS MFG IN 6/90. NEXT DAY, 10/24TH, CO SENT A MECHANICAL ENGINEER TO REVIEW THE TABLE. EQUIPMENT WAS SERVICED BY THE INDEPENDENT SERVICE GROUP, AND AT THE TIME OF VISIT THE SERVICE RECORD OF THE EQUIPMENT WAS NOT AVAILABLE. THE MECHANICAL ENGINEER BROUGHT THE BROKEN CHAIN, WHICH WAS SENT TO THE LAB FOR ANALYSIS. THE RESULT OF ANALYSIS WILL BE AVAILABLE IN 1-2 WEEKS. CO CONDUCTED ENGINEERING MEETING ON 10/30/96. THE PRELIMINARY REVIEW CONDUCTED BY THE ENGINEERING TEAM, SHOWED THAT CO STARTED TO PRODUCE THIS TABLE IN 1985, AND SHIPPED 74 TABLES OF THIS CONFIGURATION. APPROX HALF OF PRODUCED TABLES ARE OLDER THAN THE TABLE IN MED CTR, AND SOME OF THEM IN OPERATION FOR 11 YEARS. CO HAS REVIEWED THE CO'S SERVICE RECORD OF THIS PRODUCT AND DETERMINED, THAT IT IS THE FIRST REPORTED OCCURRENCE OF THIS TYPE OF MALFUNCTION. THE PRELIMINARY DESIGN REVIEW SHOWS THAT THE CHAIN IS RATED 4.5 TIMED OF LOAD CAPACITY. THE MAINTENANCE SCHEDULE FOR THIS PRODUCT CALLS FOR 6-MONTHS INSPECTION OF ALL CHAINS FOR SIGN OF WEAR OR DAMAGE. CO WILL CONTINUE THE INVESTIGATION OF THIS INCIDENT AND WILL KEEP FDA INFORMED OF ITS RESULTS.
WAREHOUSE MANAGER STATED THAT HE HAS A BREEZY WITH A BROKEN X-TUBE.
DEFLATED RIGHT SILICONE BREAST IMPLANT REMOVED. THE IMPLANT IS 30 YEARS OLD SO NO KNOWN INFO WAS AVAILABLE. PT HAD RIGHT CAPSULECTOMY. THERE WAS ONE SMALL INTERRUPTION AS THE CAPSULE WAS BEING REMOVED AND THE INCISION IN THE CAPSULE MADE WITH ELECTROCAUTERY PRODUCED FREE SILICONE GEL. THE CAPSULE AND GEL WERE REMOVED. PT HAS HAD RECENT COMPLAINTS OF PAROXYSMAL ATRIAL FIBRILLATION WHICH WAS THOUGHT TO BE STRESS RELATED. SHE SMOKED UNTIL THE 1970'S. SHE WAS SEEN IN 1/95 FOR VISUAL DISTURBANCES AND POSSIBLE TIA. SHE HAS 3 GROWN CHILDREN.
DURING A CATARACT PROCEDURE, IT WAS NOTED BY THE SURGEON THAT THE PT SUSTAINED A SCLERAL DISTORTION AT THE WOUND SITE FOLLOWING PHACOEMULSIFICATION CONSISTENT WITH OVERHEATING. PHACO UNIT REMOVED FROM SVC AND MFR NOTIFIED. SURGEON NOTED A VERY SMALL AREA ON THE PREVIOUS PT BUT FELT IT NOT SIGNIFICANT ENOUGH TO WARRANT REPORTING UNTIL THE SITUATION REPEATED WITH AN INCREASE IN DISTORTION.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THE PT HAD A MEGACOLON CHAGASTCO AND WENT THROUGH A COLORECTAL ANASTOMOSIS WITH A DEVICE. HOWEVER, THE STAPLER DID NOT OPEN AFTER ITS FIRING . AFTER A RESSECTION OF THE ANASTOMOSIS, ANOTHER ANASTOMOSIS WAS PERFORMED WITH ANOTHER DEVICE AND HAD AN EXCELLENT RESULT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D10: INFO NOT SUPPLIED BY AFFILIATE. D5,6;H4: INFO UNAVAILABLE DEVICE NOT RETURNED FOR EVAL.
THE LEAD WAS EXPLANTED ELECTIVELY. FAILURE ANALYSIS INDICATED THE LEAD IS FRACTURED WITHOUT PROTRUSION.
THIS ENITRE FORM COMPLETED BY THE MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THAT J STIFFENER WIRE HAS FRACTURED 11MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE LEAD BODY AND THE J STIFFENER WIRE WERE CUT APPROX 13MM PROXIMAL OF WELD SITE, WITH EVIDENCE OF FLARED COIL WIRE ENDS. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX 74MM AND IS LOCATED APPROX 2MM PROXIMAL OF THE DISTAL END OF THE 44.5MM PROXIMAL SECTION OF LEAD. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE PROXIMAL END OF THE 11MM DISTAL SECTION OF J STIFFENER WIRE HAS ABRADED A HOLE IN THE OUTER POLYURETHANE INSULATION APPROX 11MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE LENGTH OF THE STIFFENER WIRE  WAS RECEIVED WITH RECORDED MEASUREMENTS ADDING UP TO 87MM. X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURE.
CUSTOMER REPORTS THAT PUMP WAS INFUSING AT A RATE FASTER THAN WAS PROGRAMMED ON THE PUMP. A RATE OF 90 ML/HR WAS PROGRAMMED AND AFTER 4 HRS, THE PUMP READING FOR FEED TOTAL WAS OVER 600 MLS. THE PUMP WAS THEN REMOVED FROM THE PT.
THE CAUSE WAS TRACED TO A ROTOR SENSOR SIGNAL OUTSIDE THE DETECTION LIMITS SET BY THE PUMP SOFTWARE. SPECIFICALLY, THE ROTOR-SENSE PULSE WIDTH GENERATED WA LESS THAN THE REQUIRED VALUE OF 80 MSEC. ALTHOUGH CO HAS HAD ONLY ONE REPORTED INCIDENT, A DECISION WAS MADE TO ISSUE A PRODUCT CORRECTION NOTICE TO DISTRIBUTORS AND PUMP USERS. THE NOTICE WAS ISSUED ON 12/4/96. TWO TESTS WERE INCLUDED AS ATTACHMENTS FOR DETECTING THE PROBLEM; THERE WAS A THIRD OPTION OF RETURNING THE PUMP TO THE PLANT FOR TESTING. ALSO, UPDATE CLEANING INSTRUCTIONS WERE PROVIDED TO HELP PREVENT THE PROBLEM FROM ARISING IF THE PUMP ROTOR IS NOT PROPERLY REATTACHED WERE PROVIDED TO HELP PREVENT THE PROBLEM FROM ARISING IF THE PUMP ROTOR IS NOT PROPERLY REATTACHED AFTER CLEANING. MEANWHILE, RAND D HAS DEVELOPED A SOFTWARE FIX. AS SOON AS AUTHORIZED, CUSTOMERS WILL BE NOTIFIED TO RETURN PUMPS FOR UPGRADING.
PT UNDERWENT X-RAY DIRECTED PROCEDURE TO REMOVE FRACTURED CATHETER PIECE LODGED IN RIGHT PULMONARY ARTERY. PT TOLERATED PROCEDURE WELL. DISCHARGED HOME SAME DAY.
THE DEVICE WAS USED DURING AN ESOPHAGOGASTRECTOMY. IT WAS REPORTED BY THE REP. THAT THE ESOPHAGOGASTRECTOMY WAS NOT COMPLETED BECAUSE THE DEVICE COMPLETED THE CUTTING BUT NOT THE STAPLING. ANOTHER INSTRUMENT DEVICE HAS TO BE USED TO COMPLETE THE PROCEDURE PROPERLY. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION BASED ON INFO RECEIVED AND VISUAL AND FUNCTIONAL RESULTS, IT APPEARS INSTRUMENT WAS NOT FIRED THROUGH A COMPLETE FIRING STROKE. THIS IS EVIDENCED BY BREAKAWAY WASHER BEING RETURNED UNCUT BUT WITH AN INDENTATION AROUND ENTIRE CIRCUMFERENCE. IT SHOULD BE NOTED THA TO ENSURE INSTRUMENT HAS ACHEIVIED A COMPLETE FIRING STROKE, FIRING TRIGGER MUST BE FULLY ACTUATED. A TACTILE FEEDBACK WILL BE FELT WHEN BREAKAWAY WASHER HAS BEEN FULLY CUT. INSTRUEMNT WAS RELOADED AND FIRED. IT CUT THROUGH BREAKAWAY WASHER AND FIRED AND FORMED STAPLES AS DESIGNED AROUND ENTIRE STAPLE RING WITH NO DIFFICULTIES NOTED. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF REPORTED INCIDENT.
THE SIDELOCK BROKE WHEN OPENING IT. OPENING WAS DONE WITH CO TOOLS. REASON FOR RE-OPERATION AFTER TWO WEEKS WAS NOT GIVEN, NOR WOULD THE PHYSICIAN TELL WHICH LEAD WAS IMPLANTED (PROBABLY NOT CO'S). PACEMAKER IS EXPLANTED AND WILL BE RETURNED TO OTHER CO, WHO WILL SEND IT TO CO. THE SERIAL NUMBER OF THE PACEMAKER IS NOT YET KNOWN. THIS IS THE SECOND TIME IN A SHORT TIME THAT A SIDELOCK WAS DAMAGED AT THIS CENTER.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP. THE STAPLES MALFORMED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D5,6,10;H4;INFO NOT PROVIDED BY AFFILIATE.
THE PUMP WAS USED WITH THE FOLLOWING SETTINGS: A RATE OF 85 ML/HR, A DOSE OF 450 ML, AND AN INTERVAL OF 12 HRS. SHE INDICATED THAT THE PUMP DID NOT STOP AFTER DELIVERING 450 MLS, BUT RATHER INFUSED THE ENTIRE CONTENTS OF THE FEEDING SET IN THE INITIAL 12 HR INTERVAL. SHE INDICATED THAT THIS OCCURRED SEVERAL TIMES, WITH THE LARGEST TOTAL INFUSION BEING APPROX 525 ML, WHICH IS AN OVER-INFUSION BY APPROX 174%. SHE INDICATED THAT THERE WERE NO INJURIES OR MEDICAL COMPLICATIONS INVOLVED.
PRELIMINARY TESTING FOUND THE PUMP TO BE FUNCTIONING PROPERLY. ADDITIONAL TESTING WAS PERFORMED BASED UPON THE CUSTOMERS REPORTED METHOD OF USAGE. THE PUMP WAS TESTED WITH THE SETTINGS REPORTED BY THE CUSTOMER. IT WAS ALSO TESTED AT FOUR OTHER SETTING CONFIGURATIONS. IN EACH INSTANCE THE PUMP FUNCTIONED PROPERLY. COMPLAINT COULD NOT BE DUPLICATED. THIS REPORT MAY BE BASED UPON INFORMATION NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURHTERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE FACILITY HAS NOTICED BROKEN BLOOD PUMP ROTOR SPRINGS ON MACHINES DURING DIALYSIS DUE TO PRESSURE FLUCTUATIONS AND/OR DURING P.M. PROCEDURES. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. A REVIEW OF CPF/DTF HISTORIES WERE NOT POSSIBLE DUE TO AN UNK SERIAL NUMBER. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT THE SPRING WAS BROKEN INTO SEVERAL PIECES. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW. THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND/OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET. IF UNDETECTED, A BROKEN ROTOR SPRING CAN RESULT IN A LESS EFFICIENT DIALYSIS FOR THE PT. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATMOSPHERIC PRESSURE. A PUNCTURE ON THE VENOUS SIDE COULD RESULT IN BLOOD LOSS AND POSSIBLE CONTAMINATION. THIS ALARM GENERATES A VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE ABOVE INFO INDICATES THAT THE PM FAILURES AND PRESSURE FLUCTUATIONS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS SEE FAR #960018. FAILURE CODES: F CODE SLNCL902WR. CUSTOMER CONTACTED: YES. SALES SVC CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
PT CAME IN FOR A ROUTINE FOLLOW-UP. THE NURSE COULD NOT INTERROGATE THE PACEMAKER WITH EITHER PROGRAMMER. MAGNET RATE SHOWED 5 BEATS AT 90, A PAUSE OF ABOUT 1500MSEC, AND THEN MORE PACING AT 90. NURSE COULD NOT TELL IF THERE WAS A NONCAPTURING STIMULUS DURING THE PAUSE. USE OF THE "SF3" SET GAIN FUNCTION RETURNED "NO SIGNAL" REPEATEDLY WITH BOTH PROGRAMMERS.
THE OBSERVED NO COMMUNICATION CONDITION WAS THE RESULT OF A "SHORTED" DIODE IN THE TELEMETRY OUTPUT CIRCUITRY. THE DEVICE WAS SUBJECT TO BATTERY ANALYSIS AND FOUND TO BE EXPIRED-NORMAL.
AFTER IABP FOR 40 MINUTES, BLOOD LEAKED INTO THE EXTENSION TUBING. THE PT WENT ON TO EXPIRE. THE DR COMMENTED THAT "THE DEATH WAS NOT CAUSED BY THE IAB." EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 10/21/96. PT'S CURRENT STATUS: EXPIRED-RPT'D 10/21/96.
DEVICE LABEL CODES: 1738, 1738. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
CUSTOMER REPORTS TWO SYRINGES IN BOX HAD FOREIGN MATERIAL IE, DIRT, DRIED BLOOD, ETC. THE SYRINGES WERE NOT USED.
REFERENCE MFR COMPLAINT # N96-10-14-116. NO SAMPLES WERE RETURNED BY THE CUSTOMER. UNITS FROM THIS LOT WERE EVALUATED AND NO CONTAMINATION WAS OBSERVED. A REVIEW OF THE LOT HISTORY FOUND 1/3000 UNITS INSPECTED DURING PRODUCTION WAS FOUND TO HAVE BROWN PLASTIC FOREIGN MATERIAL (NOT BLOOD). FIRST AID LOGS REVEALED NO CUTS OCCURRED DURING THE PRODUCTION OF THIS LOT. THESE SYRINGES ARE NOT TOUCHED BY HUMANS AFTER THE PRODUCT PIECES ARE LOADED INTO THE ASSEMBLY MACHINERY. MANUFACTURING REPORTS HANDLING OF PARTS IS UNACCEPTABLE. CO IS UNABLE TO DETERMINE THE ACTUAL CONTAMINATE WITHOUT THE SAMPLE. IT IS POSSIBLE THE CUSTOMER SAW A PIECE OF BROWN PLASTIC, AS REPORTED FINDING IN ONE SAMPLE DURING MANUFACTURE.
RECEIVED MEDWATCH FORM FROM RN, STATING "WHILE USING THE DISPOSABLE CLIP APPLIER THE APPLIER FIRED CLIPS INTO THE ABDOMEN WITHOUT ATTACHING TO THE TISSUE APPROPRIATELY. MD REMOVED CLIPS." THE PROCEDURE WAS DELAYED.
A4;B6,7; D6,10; F2,9,10; H4: INFO NOT PROVIDED ON USER FACILITY MEDWATCH FORM. 10/9/96 1050 MESSAGE AND 800# FOR CONTACT PERSON. 1345 RN CALLED BACK AND PROVIDED THE PROCEDURE AND SURGEON'S NAME. SHE STATED THE INSTRUMENT WAS PROBLEMATIC FROM THE START AND THE CASE WAS COMPLETED WITH A NEW INSTRUMENT. ALL UNFORMED CLIPS WERE RETRIEVED FROM THE PT. 10/10/96 1150 STATED THE DR IS ON VACATION UNTIL MONDAY. 10/10/96 1155 NNCL SENT.
REPORTER INDICATED THAT TEN MONTHS AFTER IMPLANTATION WITH VENTRICULAR LEAD, NO VENTRICULAR OUTPUT IN THE DDD OR VVI MODE WAS SEEN; INCLUDING WHEN THE MAGNET WAS APPLIED. THE VENTRICULAR LEAD IMPEDANCE MEASURED "HIGH OHMS." AN X-RAY DID NOT SHOW ANY APPARENT FRACTURE OR DISCONNECTION AND THE LEAD TESTED OK - WHEN TESTED INVASIVELY. THE DEVICE WAS EXPLANTED. DATE OF EVENT UNK.
CLOSED ON 10/21/96- TEST O.K. THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING, ENVIRONMENTAL STRESS TESTING, AND CONNECTOR DIMENSIONAL ANALYSIS. NORMAL PACER OPERATION WAS OBSERVED. THE PACER IS OPERATING WITHIN NEW PACER SPECIFICATIONS.
THE SHEATH WAS DEFECTIVE. NO OTHER INFO WAS PROVIDED BY THE CONTACT AT THIS TIME. EVENT COMPLICATIONS: UNKNOWN-REPORTED 10/15/96. PT'S CURRENT STATUS: UNK-RPT'D 10/15/96.
DEVICE LABEL CODES: 1701. A DATASCOPE 10 FRENCH, 6 INCH SHEATH/HEMOSTASIS VALVE ASSEMBLY WAS RETURNED FOR EVALUATION. BLOOD WAS NOTED ON THE EXTERIOR AND INTERIOR OF THE DEVICE. SEVERAL KINKS WERE NOTED IN THE SHEATH TUBING. THE SHEATH I.D. WAS MEASURED AND FOUND TO BE WITHIN DATASCOPE'S MFG SPECIFICATIONS. IN ADDITION, WHEN THE VACUUM WAS DRAWN AND MAINTAINED ON A FOLDED LABORATORY IAB, IT WAS POSSIBLE TO PASS THE MEMBRANE THROUGH THE RETURNED SHEATH/HEMOSTASIS VALVE ASSEMBLY WITHOUT DIFFICULTY. PROBABLE CAUSE OF DIFFICULTY: NO DEFECT WAS FOUND IN THE SHEATH DURING LABORATORY EXAMINATION. KINKING OF THE SHEATH MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: 1. DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. 2. THE PATIENT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR SHEATH INSERTION.
THE REPORTER INDICATED THAT THE DEVICE IS AT VVI PACING AT 75 PPM (BACKUP MODE).
IT WAS REPORTED A BALLOON DEVELOPED A PIN-HOLE LEAK DURING PREPARATION VIA HAND INFLATION FOR A PERIPHERAL ANGIOPLASTY. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. WITHOUT EVALUATING THE PRODUCT, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "AS SUPPLIED THE BALLOON LUMEN OF THE BALLOON DILATATION CATHETER CONTAINS AIR. THIS AIR MUST BE DISPLACED TO MAKE CERTAIN THAT ONLY LIQUID FILLS THE BALLOON WHILE THE CATHETER IS IN THE BLOODSTREAM. TO DISPLACE AIR... INJECT JUST ENOUGH CONTRAST MIXTURE TO PARTIALLY INFLATE THE BALLOON... TO MAKE CERTAIN THAT ALL AIR IS REMOVED FROM THE BALLOON, REPEAT..."
THE ENDUSER REPORTED THAT DURING A PTCA PROCEDURE CO'S LARGE BORE Y-ADAPTOR COULD NOT BE TIGHTENED SUFFICIENTLY AROUND A BALLOON CATHETER TO PREVENT BLOOD LEAKAGE. NO INJURY TO THE PT RESULTED.
THE RETURNED PRODUCT WAS EXAMINED AND FONUND TO BE WITHIN SPECIFICATIONS. IT IS THIS CONCLUSION THAT THE BALLOON CATHETER WAS POSITIONED IN THE Y-ADAPTOR IN A MANNER WHICH DID NOT ALLOW FOR THE DESIRED LEVEL OF HEMOSTASIS TO BE ACHIEVED. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF NAMIC USA CORP. THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
THE FACILITY HAS NOTICED BROKEN BLOOD PUMP ROTOR SPRINGS ON MACHINES DURING DIALYSIS DUE TO PRESSURE FLUCTUATIONS AND/OR DURING P.M. PROCEDURES. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. A REVIEW OF THE CPF/DTF HISTORIES WERE NOT POSSIBLE DUE TO AN UNK SERIAL NUMBER. THE RETURNED BLOOD PUMP ROTOR WAS VISUALLY INSPECTED AND CONFIRMED THAT ONE OF THE SPRINGS ON THE ROTOR WAS BROKEN. UPON DISASSEMBLY OF THE ROTOR IT WAS NOTICED THAT THE SPRING WAS BROKEN INTO SEVERAL PIECES. IF A ROTOR SPRING BREAKS, ONE OF THE TWO ROLLERS ON THE BLOOD PUMP WILL NOT MAKE COMPLETE CONTACT WITH THE HEADER TUBING, AND BLOOD FLOW AND PRESSURES WITHIN THE BLOOD SET WILL BE ERRATIC AND LOW. THE FACILITY TYPICALLY IDENTIFIES THE BROKEN SPRING BY NOTING LOW PRESSURES AND/OR ERRATIC DRIP CHAMBER FLOWS AND LEVELS IN THE BLOOD TUBING SET. IF UNDETECTED, A BROKEN ROTOR SPRING CAN RESULT IN A LESS EFFICIENT DIALYSIS FOR THE PT. IF THE SPRING BREAKS DURING DIALYSIS AND THE BLOOD TUBING SET IS PUNCTURED ON THE ARTERIAL SIDE, THE NEGATIVE PRESSURE SIDE OF THE BLOOD TUBING SET, THIS WOULD CAUSE AN "ARTERIAL PRESSURE HIGH" ALARM SINCE THE MACHINE WOULD INCREASE THE PRESSURE TOWARDS ATMOSPHERIC PRESSURE. A PUNCTURE ON THE VENOUS SIDE COULD RESULT IN BLOOD LOSS AND POSSIBLE BLOOD CONTAMINATION. THIS ALARM GENERATES A VISUAL RED FLASHING LIGHT, A STEADY AUDIBLE ALARM, STOPS THE BLOOD PUMP, AND CLAMPS THE VENOUS BLOOD LINE. THE ABOVE INFO INDICATES THAT THE PM FAILURES AND PRESSURE FLUCTUATIONS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960018. FAILURE CODES: F CODE SLNCL902WR. CUSTOMER CONTACTED: YES. SALES/SVC CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
THE LEAD FRACTURED. VENTRICULAR LEAD IMPEDENCE WITH THE ANALYZER WAS >2000 OHMS. NO VENTRICULAR OUTPUT SPIKES AT 10 VOLTS. WERE OBSERVED. A LEAD FRACTURE WAS NOTED ON FLUOROSCOPE. THE LEAD WAS CAPPED AND A NEW LEAD WAS INSERTED.
REFERENCE SECTION F10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE DEVICE WILL NOT BE RETURNED.
THE SOURCE REPORTED THAT DURING PT USE, THE DEVICE FAILED TO ALARM AT THE END OF INFUSION. THERE WAS NO PT INJURY.
THIS M.D.R.IS BEING FILED IN ORDER TO COMPLY WITH 21 CFR PART 803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT THE DEVICE ACTUALLY MALFUNCTIONED OR CAUSED ANY INJURY. H3: THE EVAL OF THIS DEVICE IS NOW COMPLETE.
THE DR NOTED A LITTLE RESISTANCE WHEN THE IAB WAS INSERTED INTO THE PT. AFTER FOUR HRS OF IABP, THE "HELIUM GAS LEAK" ALARM SOUNDED FROM THE PUMP. BLOOD LEAKED INTO THE CATHETER. EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 10/18/96. PT'S CURRENT STATUS:UNK-RPT'D 10/18/96.
DEVICE LABEL CODES: 1701, 1738, 1738. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
DEVICE WAS SHOWING A TRANSTELEPHONIC MAGNET RATE OF 96 PPM. WITHOUT MAGNET, THE RATE IS 72 PPM WITH APPROPRIATE CAPTURE AND SENSING. AT THE PREVIOUS FOLLOW-UP, THE UNIT WAS PROGRAMMED TO 72, BUT WAS PACING AT 80 PPM, WHICH IS BACKUP MODE.
ANALYSIS SUMMARY: THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING AND BATTERY DISCHARGE ANALYSIS. NORMAL PACER OPERATION WAS OBSERVED. THE BATTERY EXPIRED NORMAL.
AN ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE. UPON INITIAL INFLATION ATTEMPT, THE BALLOON RUPTURED LEAVING THE STENT PARTIALLY EXPANDED. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PATIENT WITHOUT COMPLICATION AND ANOTHER BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
DEVICE LABEL CODES: 1738, 1738. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECTED TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY.
THE IAB WAS INSERTED INTO THE PATIENT ON 10/7/96. ON 10/11/96 AFTER THE IABP FOR ABOUT FOUR DAYS, THE IAB WAS BEING REMOVED AND A "CLOT" WAS NOTED INSIDE THE IAB WHICH CAUSED THE REMOVAL TO BE DIFFICULT. ON 11/7/96, THE FOLLOWING WAS REPORTED TO DATASCOPE: INFLATION CONTINUED WITHOUT AN INDICATION THAT THERE WAS A LEAK. NO ALARMS SOUNDED. PATIENT'S CURRENT STATUS: DISCHARGED - RPT'D 11/7/96.
BLOOD IN TUBING WAS NOTED AFTER AN UNDETERMINED AMOUNT OF TIME.
H-11 ALL UNK INFO REQUESTED BUT NOT REC'D H-11 SECTION F PROVIDED BY MANUFACTURER.
A VAGUE REPORT WAS RECEIVED THAT THE INFUSION PUMP OVER INFUSED AND "DELIVERED TWICE THE AMOUNT SET TO BE DELIVERED." NO ADD'L INFO WAS ABLE TO BE RECEIVED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WITHIN SPECIFICATION.
SUMMARY OF EVAL: EVAL OF THIS EVENT CANNOT BE PERFORMED BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO CO. THE DEVICE WAS IMPLANTED. DUE TO TOLERANCES REQUIRED TO MANUFACTURE THE METAL SHELL AND THE POLYETHYLENE INSERT OF THIS PRODUCT, SOME TOGGLE MAY BE PRESENT BETWEEN THE COMPONENTS OF THIS DEVICE. THIS SLIGHT TOGGLE IS WITHIN FINAL INSPECTION ACCEPTABLE STANDARD FOR THIS PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED, AS THE LOT CODE PROVIDED WAS NOT VALID.
UPON OPENING, IT WAS NOTICED THAT THE INNER BLISTER CONTAINED A SMALL HOLE. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
THE CONDITION OF THE RETURNED ASNIS II GUIDED SCREW PACKAGE WOULD SUGGEST THAT THIS DAMAGE WAS DUE TO MISHANDLING DURING THE DISTRIBUTION NETWORK OF THIS DEVICE.
OVERDELIVERY NOTED BY EQUIPMENT TECH DURING ROUTINE PUMP TESTING BETWEEN PT USE. THE PT THAT HAD JUST RETURNED THE DEVICE DID NOT REPORT ANY PROBLEMS WITH THE PUMP. DURING TESTING, THE PUMP CONSISTENTLY DELIVERED 8 ML WHEN THE EXPECTED DELIVERY AMOUNT WAS 2 ML.
THE CUSTOMER SET WAS NOT RETURNED FOR TESTING. AN INFUSION TEST WAS RUN WITH THE PUMP PROGRAMMED TO INFUSE AT 400ML/HR. THE PUMP ALARMED "SYSTEM" AFTER THE SCREEN DISPLAYED 2ML INFUSED. HOWEVER, 7.28G WAS MEASURED. THE MOTOR TACH PULSE WAS CHECKED AND WAS FOUND TO BE OUT OF SPEC. AFTER INSTALLING A TEST MOTOR, THE INFUSION TEST WAS COMPLETED WITHIN SYSTEM SPECS.
THE BALLOON WOULD NOT DEFLATE. NO FURTHER DETAILS WERE PROVIDED. NO PT INJURY REPORTEDLY ASSOCIATED WITH THIS EVENT.
SECTION H6: RESULTS (C0DE 300: OTHER) DEVICE WAS NOT TESTABLE. RECREATION OF THE REPORTED COMPLAINT WAS NOT POSSIBLE DUE TO HARDENED CRYSTALLIZED CONTRAST PRESENT IN THE INFLATION PORT. ATTEMPTS TO INFLATE THE BALLOON WERE UNSUCCESSFUL. A REVIEW OF THE MANUFACTURING DATA FOR THIS DEVICE FOUND NO ABERRACIES. ENGINEERING WAS NOT ABLE TO ESTABLISH A ROOT CAUSE OR CORRECTIVE ACTION DUE TO THE CONDITION OF THE RETURNED DEVICE. QA WILL MONITOR THE DEVICE FOR THIS TYPE OF COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPARTMENT.
THE TIBIAL INSERT WOULD NOT LOCK IN TO THE BASEPLATE. ANOTHER DEVICE WAS READILY AVAILABLE AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
SUMMARY OF EVALUATION: THE DEVICE WAS VISUALLY AND DIMENSTIONALLY INSPECTED AS RECEIVED. THIS INSERT HAS BEEN AUTOCLAVED CAUSING SURFACE DISTORTION WHICH MAY AFFECT THE EVALUATION. THE INSERT AS RECEIVED WAS SNAPPED ONTO FOUR BASEPLATES USING TWO-THUMS PRESSURE WITH THE RESULTS OF CRISP SNAP ACTION AND FULL, TIGHT SEATING ON ALL OF THE BASEPLATES. IMPACTION WAS NOT REQUIRED IN ANY TEST. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT OF INSERTS FOUND THAT ALL ATTRIBUTES WHICH COULD HAVE AFFECTED THIS EVENT MET DESIGN REQUIREMENTS DURING MANUFACTURE. THE EVALUATION RESULTS, ALTHOUGH NOT CONCLUSIVE IN THE ABSENCE OF THE EVENT BASEPLATE, SUGGESTS THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES.
PHYSICIAN ATTEMPTED TO REMOVE CATHETER FROM PT'S CHEST WALL AND TUBING SNAPPED OFF INSIDE PT. SURGEON NOTIFIED FOR LOCAL SEDATION AND REMOVAL OF REMAINING CATHETER.
PT HAD ROUTINE REMOVAL OF SUPRA PUBIC TUBE IN OFFICE. CLEARLY BROKEN UPON REMOVAL. NO DIFFICULTY WITH REMOVAL. KUB SHOWED RESIDUAL TUBE IN BLADDER. CYSTO 48-72 - REMOVAL OF REMAINING SUPRA PUBIC TUBE REMNANT.
THE THREADED TIP OF THE INNER ROD DRIVER BROKE, LEAVING A PORTION FIXED INSIDE THE THREADED PROXIMAL HOLE OF THE FRACTURE STEM. THE SURGEON WAS ABLE TO SEAT THE IMPLANT USING AN ALTERNATIVE METHOD. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT DUE TO THIS EVENT.
SUMMARY OF EVAL: THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO USER TECHNIQUE. THE INNER ROD WAS NOT FULLY SECURED TO THE STEM DURING IMPACTING. THE AGENT TO INSTRUCT THE USER ON PROPER ASSEMBLY AND USE OF THE EXTRACTOR INSTRUMENT. F1-14: HAS BEEN COMPLETED BY THE MFR. ATTACHED IS USER FACILITY REPORT.
A FACILITY REPORTED THAT 8 PTS HAD EXCESSIVE ULTRAFILTRATION WHILE DIALYZING ON ONE PARTICULAR MACHINE. SEVEN PTS HAD EXCESS ULTRAFILTRATION BETWEEN .5 AND 1 KILOGRAM. THE EIGHTH PT TO DIALYZE ON THIS MACHINE HAD LOST AN EXCESS OF 1.3 KG OF FLUID MORE THAN THE MACHINE WAS SET TO REMOVE. THE PT BECAME HYPOTENSIVE, REC'D NORMAL SALINE AND COMPLETED THE TREATMENT. NO PT INJURY. THE MACHINE WAS REMOVED FROM THE TREATMENT AREA FOR SVC BY THE MFR. THE UF PUMP WAS REBUILT AND UF CHECK VALVE REPLACED, PROPER MACHINE OPERATION WAS VERIFIED.
BLOCK F COMPLETED BY MFR. F10 SYMPTOMS ADDRESSED IN DEVICE LABELING.
DURING A TURP, THE RESECTOSCOPE TIP BROKE. THE TIP BECAME LODGED IN THE RESECTOSCOPE. THE PROCEDURE WAS COMPLETED USING A LARGER PIECE OF EQUIPMENT.
THIS TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE INFO PROVIDED AND THE EXAMINATION RESULTS, ALTHOUGH NOT CONCLUSIVE IN THE ABSENCE OF THE EVENT BASEPLATE, SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES.
THE MIXER LID DID NOT FIT ONTO THE BASE, RESULTING IN THE CEMENT NOT MIXING TO A PROPER CONSISTENCY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
THE ROOT CAUSE OF THIS FIELD EVENT IS ATTRIBUTED TO IMPROPER POSITIONING OF THE SYRINGE PISTON PRIOR TO THE INTRODUCTION OF THE POWDER AND LIQUID COMPONENTS. THE SYRINGE PISTON MUST BE POSITIONED AT THE BOTTOM OF THE SYRINGE BODY IN ORDER FOR PROPER MIXING UNIT OPERATION. THE SALES REPRESENTATIVE HAS BEEN INSTRUCTED TO INFORM THE USER OF THE PROPER MIXING TECHNIQUE.
CORRECTED DATA: H4: MANUFACTURE DATE: 05/01/95. SUMMARY OF EVALUATION: THIS DEVICE HAS NOT BEEN RETURNED; THEREFORE, EVALUATION OF THIS EVENT CANNOT BE PERFORMED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN UNSUCCESSFUL. THE DEVICE HISTORY RECORD FOR THE LOT CODE OF THE DEVICE WAS REVIEWED AND NO DISCREPANCIES WERE OBSERVED. THE INFO PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THIS EVENT IS ASSOCIATED WITH THE DEVICE.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICUTLY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
PATIENT'S CURRENT STATUS: CRITICAL - RPT'D 10/8/96.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE PT'S PENIS HAS GROWN.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT AND AN IPP DEVICE IMPLANTED DUE TO PT DISSATISFACTION-PAIN, TOO LONG.
THE LABELING ON THE BOX IS CONFUSING AND CAN BE MISLEADING. THERE ARE TWO DIFFERENT TYPES OF TEST STRIPS, ONE FOR WHOLE BLOOD AND ONE FOR CAPILLARY BLOOD. THE BOXES ARE DIFFERENT COLORS BUT THE LABELING IS SO SMALL THEY COULD EASILY BE MIXED UP.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT AND AN IPP DEVICE IMPLANTED DUE TO PT DISSATISFACTION-PT WANTED AN INFLATABLE DEVICE.
THE TIP OF THE PENCIL BECAME HOT WITH NO APPARENT DEPRESSING OF THE ACTIVATION BUTTON.
MFG WAS INFORMED. CORRECTIVE ACTION HAS BEEN TAKEN. (EVAL SUMMARY) THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 10/15/96 AND 10/16/96. DURING THE FIRST TESTING SESSION, THE PENCIL PERFORMED AS INTENDED. HOWEVER,THE MFG SITE (OFF PREMISES) INITIALLY COULD NOT GET THE PENCIL TO ACTIVATE. THE PENCIL WAS DISASSEMBLED AND A SMALL, LOOSE CUT WIRE WAS DISCOVERED ON THE PCB. MFG INFORMED. CORRECTIVE ACTION HAS BEEN TAKEN.
RESIDENT WAS FOUND ON FLOOR WITH BLOOD ON HEAD, R ARM AND BOTH HANDS AND BACK. RESIDENT STATES HE WAS GETTING UP TO GET DRESSED AND FELL AND HIT HIS HEAD ON THE FLOOR. A 4 CM X 2 CM KNOT WAS NOTED ON L BACK OF PT'S HEAD. CUT REQUIRED STITCHING AND STAPLES. THE BED ALARM SYSTEM DID NOT FUNCTION PROPERLY. THE PT WAS SENT TO THE ER AND RECEIVED 7 STAPLES.
SURGERY WILL BE SCHEDULED FOR LATER IN THE MONTH.
INFO RECEIVED ON 2/14/97 INDICATES THE PUMP WAS REMOVED FROM THE PT AND REPLACED ON 11/26/96 DUE TO AUTO INFLATION AND DIFFICULTY IN DEFLATING.
THE INTRA-AORTIC BALLOON WAS INSERTED WITHOUT INCIDENT. 94 HRS LATER, BLOOD WAS NOTED IN THE EXTRACORPORAL TUBING INDICATIVE OF A LEAK. THE BALLOON WAS REMOVED WITH SOME DIFFICULTY. VISUAL INSPECTION OF THE BALLOON REVEALED A HARDENED BLOOD CLOT INSIDE THE BALLOON PORTION OF THE CATHETER.
CONNECTOR ENDS SNAPPED IN HALF WHEN INSERTED INTO THE MACHINE.
THE SPONGE CONTAINER WAS EMPTY WITH BLISTERS NOTED ON PACKAGE.
SHEATH OF EACH NEEDLE RETRACTED DURING SINGLE USE.
THE GRAFT LEAKED BLOOD (QUANTITY UNKNOWN, BUT REPORTED AS INSIGNIFICANT) THROUGH A HOLE IN THE CROTCH. THE DR OVERSEWED THE HOLE AND THE BLEEDING STOPPED. THE GRAFT WAS LEFT IN. THE PT'S CONDITION IS FINE.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL. THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" HAVE NO INFO AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE BATCH NUMBER OF THE DEVICE IS NOT ATTAINABLE, THEREFORE A REVIEW OF THE MFG BATCH RECORDS IS NOT POSSIBLE.
AFTER REPLACING A G-TUBE, THE BALLOON WOULD NOT INFLATE. REMOVED TUBE AND CHECKED BALLOON, WHICH APPEARED TO HAVE A PIN HOLE IN IT.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS -HOLE IN RESERVOIR AND LACERATION IN ONE CYLINDER.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR HAD OR DAMAGE. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK.
VENTILATOR CIRCUIT WOULD NOT PASS LEAK TEST. UNABLE TO USE CIRCUIT.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 2/5/82. PLAINTIFF ALLEGES "INJURIES AS A RESULT OF IMPLANTS CONTAINING OR CONSISTING OF SILICONE, SILICONE GEL, AND/OR AN ELASTOMER MADE OF SILICONE".
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: REC'D PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MANUFACTURED, OR SOLD BREAST IMPLANTS. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF A CORP IN 1986. F10: LABELING REC'D PER LITIGATION.
THE NEEDLE BROKE IN THE ADMINISTRATION PORT. THE CARTRIDGE DID NOT LOCK PROPERLY IN THE HOLDER.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO MECHANICAL FAILURE.
SUTURE NEEDLE TIP BROKE OFF WHILE CLOSING INCISION.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 6/24/72. PLAINTIFF ALLEGES "DISFIGUREMENT AND PHYSICIAL IMPAIRMENT".
SECTION F COMPLETED BY CO AS DESCRIBED IN, INFO PROVIDED BY INITIAL REPORTER. H6: REC'D PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MANUFACTURED, OR SOLD BREAST IMPLANTS. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF A CORP IN 1986. F10: LABELING RECEIVED PER LITIGATION.
ON 2/25/94 DEVICE WAS IMPLANTED. ON 5/26/94 A CONNECTOR WAS REVISED. ON 10/10/96 THE DEVICE WAS REMOVED FROM THE PT BECAUSE IT WOULD NOT DEFLATE ENTIRELY.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS AND PAIN.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" HAVE NO INFO AVAILABLE AT THIS TIME. IF SUCH INFO SHOULD BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-NO SIMILAR COMPLAINTS AGAINST THIS BATCH. ALTHOUGH THERE ARE NO SIMILAR COMPLAINTS AGAINST THIS BATCH, THE MFR HAS IMPLEMENTED A VOLUNTARY RECALL BASED UPON A REASSESSMENT OF THE POROSITY DATA FOR THIS BATCH.
A FACILITY REPORTED THAT 7 PTS WHO HAD DIALYZED ON THE SAME MACHINE HAD EXCESSIVE FLUID LOSSES. THE NURSE HAD NOTIFIED THEIR TECHNICAL DEPT FOR MACHINE REPAIR. THE MACHINE WAS SUPPOSEDLY REPAIRED BY THE MACHINE TECH. THE LAST INCIDENT WHICH OCCURRED ON 10/10/96. THE PT HAD BEEN DIALYZING ON A REUSED DIALYZER FOR 2 HRS WHEN THE PT BEGAN CRAMPING AND HYPOTENSIVE. THE NURSE STATED THERE WERE NO UNUSUAL ALARMS DURING THE TREATMENT, BUT THAT THE TMP READING DID DROP FROM AN INITIAL READING OF 250MMHG TO 150MMHG PRIOR TO THE PT SYMPTOMS. THE TMP ALARM LIMITS WERE NOT SET FOLLOWING THE DEVICE LABELING RECOMMENDATIONS FOR HIGH PERMEABLE DIALYZERS. THE PT RECEIVED NORMAL SALINE AND THE TREATMENT WAS DISCONTINUED. THE MACHINE WAS REMOVED FROM THE TREATMENT AREA FOR SERVICE BY THE FACILITY MACHINE TECH.
THE FACILITY MACHINE TECH FOUND A VALVE LEAKING, REPLACED THE VALVE AND VERIFIED PROPER MACHINE OPERATION. BLOCK F COMPLETED BY THE MFR. F10-SYMPTOMS ADDRESSED IN DEVICE LABELING. H6.-THE FACILITY DID NOT FOLLOW THE DEVICE LABELING INSTRUCTIONS FOR SETTING THE TMP ALARM LIMITS WHEN USING A HIGHLY PERMEABLE DIALYZER.
THE PT DEVELOPED AN ABCESS IN THE AREA OF THE RESERVOIR. THE ABCESS WAS REMOVED FROM THE PT.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDERS WAS FUNCTIONAL. TUBING WAS FUNCTIONAL.
ON 4/29/96 AN AUS WAS IMPLANTED. ON 6/11/96 THE CUFF WAS REMOVED. ON 9/30/96 THE PUMP WAS REMOVED FROM THE PT. A PUMP AND CUFF WAS IMPLANTED DUE TO PREVIOUS EROSION.
THE CYLINDER AND RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -CYLINDERS.
ON 1/10/92 DEVICE WAS IMPLANTED. ON 1/7/94 THE RESERVOIR WAS REVISED. ON 10/1/96 THE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION AND INFECTION. ADD'L LOT/SER NO: 9501T 003.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PT DISSATISFACTION-WANTED A MORE SOPHISTICATED PROSTHESIS.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED, A TANDEM CUFF WAS ALSO IMPLANTED AT THIS TIME DUE TO RECURRING INCONTINENCE.
RETURNED AFTER 1 1/2 WK VACATION. DURING RPTR'S ABSENCE, CO-WORKERS STARTED TO WEAR POWDERED LATEX GLOVES AGAIN. THE HOSP WAS BACK-ORDERED FOR NON-POWDERED. BY MID-DAY RPTR STARTED HAVING SYMPTOMS OF SNEEZING, COUGHING, SCRATCHY THROAT, AND CHEST TIGHTNESS. RPTR HAD ALREADY TAKEN AN ANTIHISTAMINE FOR GENERAL ALLERGY PROBLEMS. THE RPTR WAS SENT HOME BY THE OCCUPATIONAL HEALTH NURSE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO NON-FUNCTIONING DEVICE. ADD'L LOT/SER NO: 6184M 016.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SEPCIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD A FATIGUE LEAK.
WHEN THE PROXIMAL CLAMP WAS RELEASED, THE GRAFT OOZED BLOOD (QUANTITY UNKNOWN) FROM ITS WALLS. THE BLEEDING STOPPED BY ITSELF AFTER A SHORT TIME AND THE GRAFT WAS LEFT IN. THE PT'S CONDITION IS OK.
THE PORTION OF THE GRAFT ACTUALLY INVOLVED IN THE INCIDENT WAS LEFT IN THE PT, AND SO COULD NOT BE RETURNED FOR EVAL. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. A RETURNED, UNUSED SEGMENT OF THIS GRAFT WAS EVALUATED BO CO'S CONSULTING PATHOLOGIST. A COPY OF THAT REPORT IS ATTACHED. CODE 86: THE MANUFACTURING BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-NO SIMILAR COMPLAINTS AGAINST THIS BATCH.
ON 8/6/96, CO RECEIVED A COMPLAINT CONCERNING ONE OF THERE PRODUCTS, MODEL# 3608-03 PORT. NO COMPLAINT WAS FILED UNTIL 9/24/96 WHEN THE PRODUCT WAS RETURNED. INITIAL REPORT STATES THE PORT IS SUSPECTED TO HAVE BEEN LEAKING.
PRODUCT WAS TO HAVE BEEN REPORTED ON 8/6/96, BUT PRODUCT WAS NOT RETURNED UNTIL 9/24/96. COMPLAINT WAS NOT FILED WHEN FIRST NOTIFIED OF INCIDENT. COMPLAINT WAS FILED WHEN RETURNED PRODUCT WAS RECEIVED. EVAL VERIFIED PORT DID HAVE A LEAK MALFUNCTION. HISTORY OF OCCURRENCE: FREQUENCY OF OCCURRENCE=N. SEVERITY OF OCCURRENCE=N. PORT MOLDS HAVE BEEN REWORKED TO ENSURE SUFFICIENT MATERIAL IS AT SEAMS. CYCLIC FATIGUE TESTING SHOWS IMPROVEMENT WITH FATIGUE CHARACTERISTICS OCCURRING AFTER 10X MORE CYCLES.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS--RIGHT CYLINDER.
ON 2/3/93 AN AUS DEVICE WAS IMPLANTED. ON 8/23/93 THE CUFF WAS REVISED. ON 4/24/96 THE CUFF AND BALLOON WERE REVISED. ON 10/08/96 THE PT REPORTED "UNABLE TO ACTIVATE PUMP".
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO MALFUNCTION.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK.
THE BALLOON WAS REMOVED FROM THE PT, DUE TO RECURRING INCONTINENCE, AND REPLACED. CO HAS REQUESTED ADD'L INFO.
SURGEON HAD DIFFICULTY IN INSERTING THE SCREWS. THE RPTR STATES, AS A RESULT, THE SCREWS BECAME DAMAGED. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
DIMENSIONAL INSPECTION OF SCREWS AT THE UNDAMAGED THREAD SHOWS THE THREAD DIAMETERS TO BE IN COMPLIANCE WITH ENGINEERING SPECIFICATIONS. THE AVAILABLE INFO IS NOT SUFFICIENT TO DETERMINE THE CAUSE OF THE THREAD DAMAGE.
THE MECHANICAL VENTILATOR IS A MICROPROCESSOR BASED LIFE SUPPORT DEVICE THAT HAS ENGINEERING DEFECTS THAT CAUSE IT TO ROUTINELY DISPLAY MISINFORMATION TO THE USER UNDER CERTAIN CONDITIONS. IN THE PCV MODE THE TIDAL VOLUME LED DISPLAYS A SET TIDAL VOLUME WHEN NO TIDAL VOLUME IS SET, THE FLOW RATE LED DISPLAYS A SET FLOWRATE WHEN FLOWRATE IS VARIABLE OVER A WIDE RANGE OF FLOW DURING EACH BREATH AND THE LED OVER A WAVEFORM IS ILLUMINATED WHEN THAT WAVEFORM IS NOT BEING USED. A SIMILAR PROBLEM IS TRUE FOR SET TIDAL AND FLOWRATE IN THE "CPAP" MODE. IN ADDITION CPAP IS NOT A MODE OF VENTILATION. THIS ERRONEOUS INFO PRODUCED BY THE VENTILATOR IS SOMETIMES MANUALLY CHARTED INTO THE PT RECORD AND MAY BE CONSIDERED IN CLINICAL DECISION MAKING. IDEALLY USERS SHOULD KNOW THIS IS MISINFORMATION; HOWEVER, IT WOULD BE MORE APPROPRIATE FOR THESE LED DISPLAYS TO BE OFF WHEN NOT "GENERATING" APPROPRIATE INFO. THIS MISLABELING OF A MEDICAL DEVICE SEEMS INAPPROPRIATE AT BEST AND HAZARDOUS IF NOT LIFE THREATENING TO THE VENTILATOR PT AT THE WORST.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE LABEL CODES: 1738. A USER CARTON, LABELED AS CONTAINING IAB S/N J1425626, WAS RETURNED FOR EVALUATION. EXAMINATION OF THE CARTON'S CONTENTS REVEALED THE FOLLOWING ITEMS: A STERILE IAB, S/N J1425626, WITHIN ITS BLISTER TRAY. THE TRAY POUCHES WERE SEALED AND INTACT. A COMPLETE INSERTION KIT BLISTER TRAY, LOT SS. THE TRAY TABS WERE TABS WERE INTERLOCKED. THE TRAY POUCH WAS OPENED. A LOOSE ONE-WAY VALVE AND 3-WAY STOP COCK. A BLUE USER EVALUATION FORM AND AN ABBREVIATED GUIDE. PROBABLE CAUSE OF DIFFICULTY: IT WAS REPORTED THAT THE PLASTIC OVER THE INSERTION KIT WAS OPENED. THIS WAS VERIFIED DURING LABORATORY EXAMINATION BUT VISUAL EXAMINATION REVEALED THAT THE POUCH HAD BEEN PREVIOUSLY SEALED AS EVIDENCED BY THE RESIDUAL SEAL MARKINGS ON THE CLEAR POUCH. A REVIEW OF THE MFG RECORD CARD INDICATED THAT THIS INSERTION KIT PASSED INSPECTION. UNFORTUNATELY, IT IS NOT POSSIBLE TO DETERMINE WHEN THE KIT PACKAGING WAS OPENED.
EVENT COMPLICATIONS: UNK - REPORTED 10/9/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 10/9/96.
THE DEVICE WAS REMOVED FROM THE PT DUE TO SCROTAL EROSION AND PUMP EROSION. ADD'L LOT/SER NO: BH696 009.
PUMP WAS FUNCTIONAL. BALLOON PERFORMED WITHIN SPECIFICATIONS. CUFF HAD OR DAMAGE.
ADDITIONAL INFORMATION RECEIVED ON 11/25/96 INDICATES EROSION OF CUFF.
END CAP WAS NOT ON SYRINGE IN THE PACKAGE, AND MEDICATION LEAKED OUT OF SYRINGE.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE PT WAS UNABLE TO DEFLATE PUMP. ADD'L LOT/SER NO: 5707M 023.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO SST DEFORMITY.
DIMENSIONAL INSPECTION OF SCREWS AT THE UNDAMAGED THREAD SHOWS THE TRHEAD DIAMETERS TO BE IN COMPLIANCE WITH ENGINEERING SPECIFICATIONS. THE AVAILABLE INFO IS NOT SUFFICIENT TO DETERMINE THE CAUSE OF THE THREAD DAMAGE.
INITIALLY, THE DR HAD DIFFICULTY INSERTING THE INTRODUCER DILATOR INTO THE HEMOSTASIS VALVE. IABP CONTINUED WITHOUT ANY FURTHER PROBLEMS.
CYKINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK.
DEVICE WAS REMOVED FORM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE IT WOULD NOT INFLATE.
ON 8/31/88 AN AUS DEVICE WAS IMPLANTED. ON 12/15/92 AND 7/11/94 THE BALLOON WAS REVISED. ON 11/22/94 FLUID WAS ADDED TO THE DEVICE. ON 6/20/96 THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO MALFUNCTION LOSS OF PRESSURE.
A BALLOON RUPTURED ON THE FIRST INFLATION AT EIGHT ATMOSPHERES DURING A FEMORAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATION. THIS DEVICE HAS NOT BEEN RETURNED FOR EVAL. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. FOLLOW-UP REVEALED THE LESION WAS CALCIFIED. CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE. HOWEVER, WITHOUT EVAL THE PRODUCT, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "DO NOT EXCEED THE NORMAL PRESSURE PRINTED ON THE PRODUCT LABEL. NEVER MANIPULATE THE CATHETER WITH THE BALLOON INFLATED. THE INTEGRITY OF ALL BALLOON CATHETERS MAY BE COMPROMISED BY SHARP OBJECTS OR SURFACES. NOT RECOMMENDED FOR USE IN CALCIFIED LESIONS."
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO FDA.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE S-SHAPE DEFORMITY, BULGING OF TUNICA ALBUGINEA.
BALLOON PUMP ALARMED GAS LOSS, PUMP SHUT OFF, BLOOD NOTICED IN TUBING, BALLOON REMOVED AND REPLACED WITHOUT DETRIMENT TO THE PT.
CYLINDERS AND PUMP WERE REMOVED FROM THE PT, RESERVOIR LEFT IN PLACE, AND ANOTHER DEVICE IMPLANTED BECAUSE IT WOULD NOT INFLATE.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO PERFORATION OF THE CORPUS CAVERNOSUM.
A 29-YR-OLD FEMALE HAD A LEFT MYRINGOTOMY TUBE INSERTED. WHEN SHE PRESENTED FOR THE SURGERY SHE HAD SOFT CONTACT LENSES IN HER EYES. A NURSE GAVE THE PT A SOLUTION TO SOAK THE LENSES DURING SURGERY. AFTER SURGERY THE PT PUT THE LENSES BACK IN HER EYES AND HER EYES BECAME RED AND TEARY. THE NURSE THOUGHT THE PT HAD AN ALLERGIC REACTION. WHEN THE PT WENT HOME SHE CONTINUED TO HAVE PROBLEMS AND WENT TO AN OPTOMETRIST. HE SUGGESTED THAT THE SOLUTION SHOULD NOT HAVE BEEN USED TO SOAK THE LENSES. PT SUSTAINED A CHEMICAL BURN REQUIRING FOLLOW-UP CARE. THE BOTTLE DOES NOT STATE THAT THIS SOLUTION IS NOT TO BE USED AS A SOAK FOR SOFT LENSES. THE BOX HOWEVER DOES STATE THE FOLLOWING "NOT TO BE USED AS A SALINE SOLUTION FOR RINSING AND SOAKING SOFT CONTACT LENSES."
THERE WAS A LOT OF EXCESS TUBING, THE PUMP WAS INVERTED, THE PT COULD NOT EFFECTIVELY PUMP THE DEVICE. THE EXCESS TUBING WAS REMOVED.
DEVICE BROKE 2 YRS POST-OP. THE DEVICE WAS EXTRACTED. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: HARDNESS TEST SUGGEST THE NAIL MEETS MATERIAL SPECS. NO MATERIAL FLAWS COULD BE DETECTED. THE CORRECT STRENGTH OF MATERIAL AND FEATURES OF THE FRACTURE SUGGESTS THE NAIL BROKE DUE TO MATERIAL FATIGUE.
ADDITIONAL INFORMATION RECEIVED ON 4/24/97 INDICATES THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT ON 4/19/96 DUE TO EROSION ALONG WITH THE INFECTION.
THE AUS DEVICE WAS REMOVED FROM THE PT, BECAUSE IT STOPPED FUNCTIONING-FILLED WITH BLACK FLUID, AND REPLACED.
BALLOON PERFORMED WITHIN SPECS. PUMP RESISTOR FLOW RATE NOT WITHIN SPECS.
THE "GAS LOSS" ALARM SOUNDED AND THE PUMP WAS IMMEDIATELY SHUT OFF. BLOOD WAS NOTED IN THE TUBING AND THE BALLOON WAS REMOVED AND REPLACED. THERE WERE NO COMPLICATIONS TO THE PT. ON 10/16/96, CO ALSO RECEIVED THE MANDATORY MEDWATCH FORM FROM THE DISTRIBUTOR. EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 10/16/96. PT'S CURRENT STATUS: UNK RPT'D 10/16/96.
DEVICE LABEL CODES: 1738, 1701, 1738. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
REAR TIP EXTENDERS WERE IMPLANTED IN THE PT TO LENGTHEN THE EXISTING CYLINDERS DUE TO KINKING OF THE LEFT CYLINDER. THE PT ALSO COMPLAINED OF TENDERNESS AT THE TIP OF THE PENIS. HE STATED THE DEVICE WAS AUTOINFLATING AT LEAST SIX TIMES EACH DAY. THE RESERVOIR WAS REPOSITIONED INTRAPERITONEALLY.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO BROKEN CYLINDERS.
INFO RECEIVED ON 12/6/96 INDICATES ADD'L REASON AS LEAK.
THE DEVICE WAS USED DURING A LAPAROSCOPIC COLON. IT WAS REPORTED BY THE REP THE FIRING TRIGGER BROKE UPON FIRING. A NEW INSTRUMENT WAS BROUGHT IN TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D5,6,10;H4: INFO PROVIDED BY AFFILIATE. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITION WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO "NON-FUNCTIONING."
AFTER 12 HRS OF IABP, BLOOD WAS NOTED IN THE BALLOON CATHETER. THE "CHECK IAB" ALARM SOUNDED FROM THE PUMP. EVENT COMPLICATIONS: NONE FROM THE EVENT- REPORTED 10/11/96. PT'S CURRENT STATUS: UNK-RPT'D 10/11/96.
UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE INNER LUMEN. UNDER MICROSCOPY, A SEPARATION OF THE INNER LUMEN WAS SEEN. THE ROUGH EDGED POINTS OF SEPARATION WERE IRREGULAR IN CONTOUR SUGGESTING THAT THE INNER LUMEN BROKE. THE BROKEN PORTION OF THE INNER LUMEN HAD A WHITISH APPEARANCE, INDICATING A POINT OF STRESS. PROBABLE CAUSE OF DIFFICULTY: THE IAB WAS THE RESULT OF A BREAK OF THE INNER LUMEN. IT IS POSSIBLE THAT THE IAB WAS RESTRAINED WITHIN THE AORTA DURING IABP. THIS WOULD HAVE RESULTED IN A CYCLICAL STRESS TO THE INNER LUMEN AND, ULTIMATELY, A SEPARATION AT THE POINT OF STRESS. THE IAB MAY HAVE BEEN RESTRAINED AS A RESULT OF PLACEMENT WITHIN A SUBINTIMAL SPACE, WITHIN THE SUBCLAVIAN ARTERY, OR UNDERNEATH PLAQUE. IT IS ALSO POSSIBLE THAT THE INITIAL KINK IN THE INNER LUMEN WAS MADE DURING IAB INSERTION AND THAT IABP CONTINUED TO CYCLICALLY STRESS THE TIP/INNER LUMEN JUNCTION.
DEVICE WAS REMOVED FROM THE PT, DUE TO A RUPTURED CYLINDER, AND REPLACED. ADD'L LOT/SER NO: 4520L 009.
THE AUS DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS AND RECURRING INCONTINENCE, AND REPLACED.
THE ENTIRE WAS REMOVED FROM THE PT AND REPLACED DUE TO "MALFUNCTION-IT WAS BROKEN." ADD'L LOT/SER NO: 4922P 002.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK. RESERVOIR HAD OR DAMAGE.
RN REPORTED THAT UPON START UP, IV CONTROLLER WENT INTO FREE FLOW DESPITE CONTROLLER BEING ON HOLD. LINE NOT YET CONNECTED TO PT. NO ADVERSE OUTCOME. SET WAS NOT SAVED BY RN.
PUMP PERFORMED WITHIN SPECS. BALLOON PRESSURE NOT WITHIN SPECS. CUFF HAD OR DAMAGE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO A PAINFUL PROSTATE.
TOPICAL WOUND DRESSING WAS APPLIED TO R LOWER LEG ON 10/28/95. IT WAS REMOVED 5 DAYS LATER. SKIN HAD THE APPEARANCE OF 2ND DEGREE BURN.
DURING A LUNG PROCEDURE, IT WAS REPORTED THE DEVICE LOCKED ON THE LUNG TISSUE AND WOULD NOT RELEASE. A SECOND STAPLER WAS USED TO CUT THE DEVICE OUT OF THE LUNG TISSUE AND REMOVED THE DEVICE AND TISSUE.
10/11/96 1030 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/14/96 NNCL SENT. A1,2,3,4;B6,7;D5,10;HR; INFO UNAVAILABLE. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
DEVICE WAS REMOVED FROM THE PT DUE TO MALFUNCTION. ANOTHER DEVICE WAS IMPLANTED.
THE IAB LEAKED. BLOOD WAS OBSERVED IN THE TUBING. EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 10/11/96. PT'S CURRENT STATUS: UNK RPT'D 10/11/96.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT, RESERVOIR LEFT IN PLACE, DUE TO FLUID LOSS. AN ENTIRE IPP DEVICE WAS IMPLANTED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK. CYLINDER WAS FUNCTIONAL.
FINAL ANALYSIS REVEALED RUSTED AND CORRODED DRIVENUT ASSEMBLY AND THREADED SEGMENT. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. SERIAL # PRE-DATES DRIVENUT MATERIAL CHANGE. THIS REPORT MAY BE REQUIRED BY MEDICAL DEVICE REPORTING REGULATIONS CONTAINED IN 21 CFR SECTION 803. THESE REGULATIONS ARE VAGUE IN A NUMBER OF RESPECTS SUBJECT TO DIFFERENT INTERPRETATIONS. MOREOVER, THE REGULATIONS REQUIRE CO TO MAKE A DECISION ON REPORTING BEFORE HAVING COMPLETE INFO, INCLUDING CO'S OWN ANALYSIS OF RETURNED PRODUCT. THUS, CO'S DECISION TO FILE THIS REPORT SHOULD NOT BE LOOKED UPON AS ANYTHING OTHER THAN CO TRANSMITTAL OF UNCONFIRMED FIELD INFO WHICH THE FOOD AND DRUG ADMINISTRATION HAS REQUIRED MFRS TO SUBMIT. CO BELIEVES THAT DISCLOSURE OF THE INFO REGARDING DEVICE EVAL COULD SUSTANTIALLY HARM THE COMPETITIVE POSITION. CO SUBMITS THE INFO IN CONFIDENCE EXPECTING THAT THE FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF THE FREEDOM OF INFO ACT. CO BELIEVES THAT ANY DISCLOSURE OF THE INFO BY A FEDERAL EMPLOYEE COULD CONSTITUTE A VIOLATION OF THE CRIMINAL LAW (18 U.S.C. SECTION 1905).
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO INFECTION. ADD'L LOT/SER NO: AL425 009.
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT, DUE TO FLUID LOSS--RESERVOIR TUBING, AND REPLACED.
DURING A LAPAROSCOPIC HERNIA REPAIR, IT WAS REPORTED THE BALLOON BURST AFTER 23 PUMPS. THERE WAS NO CONSEQUENCE TO THE PT.
EVALUATION SUMMARY INADVERTANTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE BALLOON HAD BURST, MAKING THE INSTRUMENT NON FUNCTIONAL. THE INSTRUMENT WAS RECEIVED WITH A BURST BALLOON AND THE BALLOON WAS OBSERVED TO BE IN ONE PIECE. THERE WERE 2 SPIRALLING TEARS, WHICH RAN THE LENGTH OF THE BALLOON. THE POINT OF PROPAGATION COULD NOT BE DETERMINED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE BALLOON TO BURST "AFTER 23 PUMPS" DURING SURGERY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY.
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT DUE TO INFECTION-SCROTUM. THE CYLINDERS WERE LEFT IN PLACE AND THE TUBING WAS PLUGGED.
AFTER IABP FOR TWO DAYS, BLOOD WAS NOTED BACK INTO THE SYSTEM PUMP. EVENT COMPLICATIONS: UNKNOWN-REPORTED 10/11/96. PT'S CURRENT STATUS: CRITICAL-RPT'D 10/11/96.
DEVICE LABEL CODE FOR F10. POSITION 1 AND 2: 1738. THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION INSPITE OF NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR THE RETURN OF THE PRODUCT.
DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS, AND REPLACED. ADD'L LOT/SER NO: AC752 005.
A CYLINDER WAS REMOVED FROM THE PT DUE TO MALFUNCTION-EROSION OF RIGHT CYLINDER.
INFO RECEIVED INDICATED AN IPP DEVICE WAS REMOVED FORM THE PT, REASON NOT INDICATED, AND REPLACED. CO HAS REQUESTED ADD'L INFO.
DURING A LAPAROSCOPIC HERNIA REPAIR, IT WAS REPORTED BY THE REP THE INSTRUMENT JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6;H4: INFORMATION UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION. H6; EVALUATION CODE #100(OTHER):"THE INSTRUMENT WAS RECEIVED WITH EXCESSIVE DRIED BODY TISSUE IN THE CARTRIDGE NOSE, WHICH WOULD NOT ALLOW THE STAPLES TO FEED. THE DRIED BODY TISSUE WAS CLEARED FROM THE NOSE AND THE INSTRUMENT THEN FUNCTIONED AS DESIGNED AND FIRED THE REMAINING STAPLES WITHOUT INCIDENT." RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "JAMMED" DURING SURGERY MAY HAVE BEEN DUE TO EXCESSIVE DRIED BODY TISSUE IN THE CARTRIDGE NOSE. THE INSTRUMENT WAS RECEIVED WITH EXCESSIVE DRIED BODY TISSUE IN THE CARTRIDGE NOSE. THE INSTRUMENT WAS CYCLED, BUT THE STAPLE WOULD NOT FEED DUE TO THE EXCESSIVE TISSUE WEDGED IN THE NOSE. THE EXCESSIVE DRIED BODY TISSUE WAS CLEARED FROM THE CARTRIDGE NOSE AND THE INSTRUMENT THEN CYCLED AND FIRED THE REMAINING 7 STAPLES WITHOUT INCIDENT. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS-TUBING, AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDERS PERFORMED WITHIN SPECIFICATIONS. TUBING HAD A FATIGUE LEAK.
EVAL SUMMARY: FINAL ANALYSIS REVEALED RUSTED AND CORRODED DRIVENUT ASSEMBLY AND THREADED SEGMENT. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. SERIAL # PRE-DATES DRIVENUT MATERIAL CHANGE. DISCLAIMER: THIS REPORT MAY BE REQUIRED BY MEDICAL DEVICE REPORTING REGULATIONS CONTAINED IN 21 CFR SECTION 803. THESE REGULATIONS ARE VAGUE IN A NUMBER OF RESPECTS AND SUBJECT TO DIFFERENT INTERPRETATIONS. MOREOVER, THE REGULATIONS REQUIRE US TO MAKE A DECISION ON REPORTING BEFORE HAVING COMPLETE INFO, INCLUDING ITS OWN ANALYSIS OF RETURNED PRODUCT.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO AUTO INFLATION.
PUMP PERFORMED WITHIN SPECIFICATIONS. TUBING WAS FUNCTIONAL.
UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITIED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
THE IAB WAS INSERTED INTO THE PATIENT ON 9/30/96. ON 10/7/96 AFTER IABP FOR 8 DAYS, THE "BLOOD DETECT" ALARM SOUNDED FROM THE SYSTEM 97 PUMP.
DEVICE WAS REMOVED FROM THE PT BECAUSE BOTH CYLINDERS WERE "NON-FUNCTIONING." ANOTHER DEVICE WAS IMPLANTED.
ADD'L INFO REC'D FROM MFR 9/28/01: THE RESULTS OF PHYSICAL AND CHEMICAL TESTS CONDUCTED ON THE BATCH BEFORE PACKAGING SHOWED FULL COMPLIANCE WITH SPECS.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS-INPUT TUBE.
THE IAB WAS INSERTED INTO THE PT ON 10/11/96. ON 10/12/96 AFTER IABP FOR 12 HRS, THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING. EVENT COMPLICATIONS: NONE REPORTED-REPORTED 10/14/96. PT'S CURRENT STATUS: UNK-RPT'D 10/14/96.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO A "DYSFUNCTIONAL PROSTHESIS".
PUMP PERFORMED WITHIN SPECIFICATIONS. TUBING WAS FUNCTIONAL. CYLINDER HAD OR DAMAGE. CYLINDER HAD A SEPERATION LEAK.
DURING AN LAVH, IT WAS REPORTED THE FIRST STAPLER BROKE WHEN THE SURGEON CLOSED THE INSTRUNMENT. THIS INSTRUMENT WAS PART OF THE FT050 TRAY, LOT NUMBER J43JOV. ANOTHER DEVICE WAS PULLED AND THIS INSTRUMENT ALSO MALFUNCTIONED. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
H4: INFORMATION UNAVAILABLE. NOTE: DEVICE #1;H6; EVALUATION CODE #400(OTHER): FIRING MECHANISM BROKEN.
IT WAS REPORTED THAT AN OVERINFUSION OCCURRED. THE PUMP WAS SET AT A RATE OF 4CC/HR. AFTER 1 HOUR THE SOLUTION BAG WAS EMPTY AND THE PUMP READ 'ERR'. THERE WAS NO PT COMPLICATION.
MFR'S REPORT DATE 10/31/96. THE PUMP WAS RETURNED FOR EVAL. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND THE PUMP WAS FOUND TO MEET ALL MFR'S SPECS. THERE WAS NO VISUAL DAMAGE NOTED. THE ACCURACY WAS TESTED AT SEVERAL RATES AND PASSED ALL TESTS. IT IS SUSPECTED THAT A POSSIBLE MISLOAD OF THE IV SET MAY HAVE CAUSED THE REPORTED OVERINFUSION. ADD'L INSERVICING WILL BE RECOMMENDED ON PROPER LOADING OF THE IV SET PER THE DIRECTIONS FOR USE, PAGE 9, WHICH STATES, "CLOSE THE MECHANISM BY PUSHING THE ORANGE LATCH TO THE LEFT. VERIFY THE TUBING IS FULLY WITHIN THE MECHANISM AND THE AIR IN LINE DETECTOR DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH". THIS REPORT WAS FILLED OUT BY THE MFR.
DEVICE WAS IMPLANTED ON 4/3/91. THE RESERVOIR WAS REVISED ON 7/23/91. ON  6/27/96 THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO INFECTION.
PT HAVING OPEN HEART SURGERY ON CPB. LARGE PLASMA LEAK OCCURRED INTO GAS CHAMBER.
PATIENT'S CURRENT STATUS: <GOOD - RPT'D 11/7/96.>
CAUTERY UNIT BECAME HOT AND SMOKED DURING OPERATION. REMOVED FROM SVC.
DEVICE WAS IMPLANTED ON 4/3/91. THE RESERVOIR WAS REVISED ON 7/23/91. THE LEFT CYLINDER WAS REMOVED ON 6/27/96. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 9/25/96 AS A FOLLOW-UP TO THE 6/27/96 SURGERY. ANOTHER DEVICE WAS IMPLANTED.
A PHYSICIAN REPORTED A PREGNANCY OCCURRED SUBSEQUENT TO A LAPAROSCOPIC TUBAL CLIP STERILIZATION. NO EQUIPMENT OR OTHER PROBLEMS WERE NOTED WHEN THE PROCEDURE TOOK PLACE. THE PT HAS HAD A NORMAL PREGNANCY. FALLOPIAN CLIP APPLICATOR WAS FOUND TO BE DAMAGED.
DATA IN SECTION F WAS FILLED IN BY THIS US AGEMT OF THE MFR. THE TIP OF THE INNER SHAFT WAS BENT DOWNWARD. AN INTERNAL METAL WASHER WAS MISSING FROM THE PROXIMAL END OF THE APPLICATOR. A BEND WAS ALSO NOTED ALONG THE LENGTH OF THE INNER SHAFT. THE DEVICE RECEIVED POOR CARE AND MAINTENANCE FROM THE USER. ALTHOUGH MECHANICAL DAMAGE WAS FOUND, THE CAUSE OF THE OCCLUSION FAILURE CANNOT BE DEFINITELY ATTRIBUTED TO THE CONDITION OF THE DEVICE.
DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS-CYLINDER, AND REPLACED. ADD'L LOT/SER NO: 0457M 008.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A BULGE LEAK.
INTRAVENOUS CATHETER BEING INSERTED. "SPRING BUTTON" PUSHED AND CATH DISCONNECTED FROM THE CANNULA TIP. CATHETER FELL OUT.
IT WAS REPORTED THAT THE NURSE SET UP A 100CC BAG, AND 3 1/2 HOURS AFTER THE INFUSION WAS STARTED, THE PT WAS FOUND WITH REDUCED RESPIRATION. THE NURSE THOUGHT THE VOLUME IN THE BAG APPEARED TO BE ABOUT 1/3 FULL AND THAT IT SHOULD HAVE BEEN 2/3 FULL.
MFR'S REPORT DATE 11/5/96. SECTION F2, F11, G4 G7, H2 UPDATED BY MFR.
ADDITIONAL INFORMATION RECEIVED ON 11/8/96 INDICATES REASON AS ANEURYSM AND AUTO-INFLATION.
THE RN WAS UNABLE TO MANUALLY FILL THE BALLOON USING A 60 CC SYRINGE FILLED WITH HELIUM. THE IAB WAS CHECKED FOR LEAKS AND KINKS, HOWEVER, NONE WERE DETECTED. EVENT COMPLICATIONS: UNKNOWN-REPORTED 10/15/96. PT'S CURRENT STATUS: UNK-RPT'D 10/15/96.
EVAL TO BE PERFORMED AT MFG FACILITY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVAL. THIS EVENT DID NOT OCCURR IN THE US. THERE ARE NO DEVICES UNDER THIS C/N IN USE OR MARKETED IN THE US. F1-14 HAS BEEN COMPLETED BY THE MFR. INFO RECEIVED FROM FOREIGN AFFILIATE. USER FACILITY INFO IS UNOBTAINABLE.
THE PORT CATHETER BROKE INSIDE THE PT. IT IS NOT KNOWN IF THE CATHETER EMBOLIZED. THE PORT WAS REMOVED. NO OTHER INFO IS KNOWN AT THIS TIME.
THE DEVICE IS CURRENTLY BEING RETAINED BY THE FACILITY AND WAS NOT RETURNED FOR EVAL.
A PHYSICIAN REPORTED A PREGNANCY OCCURRED SUBSEQUENT TO A LAPAROSCOPIC TUBAL CLIP STERILIZATION. NO EQUIPMENT OR OTHER PROBLEMS WERE NOTED WHEN THE PROCEDURE TOOK PLACE. THE PT HAS HAD A NORMAL PREGNANCY AND REPORTEDLY WILL CONTINUE IT TO FULL TERM. THE FALLOPIAN CLIP APPLICATOR WAS FOUND TO BE OUT OF CALIBRATION AND DAMAGED.
DATA IN SECTION F WAS FILLED IN BY THIS US AGENT OF THE MFR. THE DEVICE HAD A BENT INNER SHAFT AND THE PUSHER ROD WAS LOOSE. ALSO, THE INSTRUMENT WAS OUT OF CALIBRATION. THE APPLICATOR RECEIVED ROUGH USAGE AND HANDLING FROM THE USER. ALTHOUGH THE DEVICE WAS FOUND TO BE DAMAGED, THE CAUSE OF THE PROBLEM CANNOT BE DEFINITELY ATTRIBUTED TO THE DEVICE.
PT IN PRESSURE BED WITH RAILS UP. RAIL FOUND DOWN AND PT FOUND ON FLOOR. APPARENT MALFUNCTION OF RAIL LATCH. SMALL OPENING IN BUTTOCK'S AREA, SKIN GRAFT NOTED FROM FALL.
AFTER IABP FOR LESS THAN 24 HOURS, THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING AND THE IAB WAS REMOVED. NO SECOND WAS INSERTED. ON 3/10/97, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 10/17/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 10/17/96.
CODE 86: EVALUATION OF EVENT BASED ON MANUFACTURING AND QC PROCEDURES, AND HISTORICAL USE OF DEVICE RELATED TO THIS EVENT. THIS INFO WAS PROVIDED TO A CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. PRODUCT WAS USED UNEVENTFULLY IN LCFA FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE. FOUR DAYS POST PRODUCT THE PT PRESENTED COMPLAINING OF PAIN AND SWELLING AT PRODUCT SITE. TWO DAYS LATER PT ADMITTED THROUGH ER WITH PULSATILE MASS AND BRUIT. AT THAT TIME A PSEUDOANEURYSM WAS DIAGNOSED WHICH WAS SUCCESSFULLY TREATED WITH ULTRASOUND GUIDED COMPRESSION. CODE 200: PSEUDOANEURYSMS CAN RESULT IF THE COLLAGEN IS NOT PLACED ACCURATELY OVER THE ARTERIAL PUNCTURE SITE. HOWEVER, THIS COMPLICATION IS NOT UNUSUAL FOLLOWING CARDIAC CATHERIZATION PROCEDURES. THEREFORE, CO CAN NOT ATTRIBUTE THIS EVENT TO THE USE OF PRODUCT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE FLAPPER SEAL BUTTON PORTION OF THE SEAL BECAME DISLODGED WHILE INSERTING THE SPECIMEN RETRIEVAL BAG. THE BUTTON FELL INTO THE PT AND WAS IMMEDIATELY REMOVED BY THE SURGEON THROUGH AN ALTERNATE TROCAR. A NEW SEAL WAS PLACED ON THE CANNULA AND THE CASE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS OR DELAYS.
SIMULATION TESTING WITH AN EQUIVALENT SEAL AND ANOTHER CO'S SPECIMEN RETRIEVAL BAG REVEALED THAT UPON INSERTION THE LEADING EDGE OF THE SPECIMEN RETRIEVAL BAG DELIVERY TUBE CAN GET CAUGHT UNDER THE LEADING EDGE OF THE FLAPPER SEAL BUTTON. HOWEVER, CO WAS UNABLE TO EXACTLY DUPLICATE THE EVENT THROUGH THIS TESTING BECAUSE CO WAS UNABLE TO DISLODGE THE FLAPPER SEAL BUTTON. ADD'L TESTING REVEALED THAT BY SLIGHTLY EXTENDING THE SPECIMEN RETRIEVAL BAG BEYOND THE TIP OF THE DELIVERY TUBE PRIOR TO INSERTION, THE DELIVERY TUBE DOES NOT GET CAUGHT ON THE FLAPPER SEAL BUTTON AND THE SPECIMEN RETRIEVAL BAG IS EASILY DELIVERED TO THE OPERATIVE SITE. THIS TECHNIQUE HAS BEEN RELAYED TO CO'S SALES FORCE AND IS NOW A STANDARD PART OF CO'S INSERVICING PRODUCT PRESENTATION. THE CO ANTICIPATES NO FURTHER SUBMISSION. FREQUENCY DATA: IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING? NO. IS FREQUENCY GREATER FOR THIS EVENT THAN USUAL? NO. THE EVENT IS NOT USUAL. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING? NO. IS SEVERITY GREATER FOR THIS EVENT THAN USUAL. NO.
PERFUSIONIST ENCOUNTERED A PROBLEM WITH LEAKING CONNECTOR DURING A PROCEDURE. HE MANUPULATED THE CONNECTOR TO ALLEVIATE THE LEAKING.
H-11-ALL UNK INFO REQUESTED BUT NOT REC H-11 SECTION F PROVIDED BY MANUFACT. H-11 SECTION H6 CONCLUSION CODE 00 LABELING CAUTION USER TO CHECK FOR LEAK DURING PRIMING OF CIRCUIT.
DURING AN ECTOPIC PREGNANCY PROCEDURE, IT WAS REPORTED THE DEVICE WAS APPLIED TO A SEGMENT OF THE TUBE AND WOULD NOT RELEASE FROM THE STRUCTURE ON THE FIRST FIRING. THE DEVICE WAS FIRED AGAIN, BUT WOULD NOT RELEASE. A PROBE WAS USED TO PULL APART THE DEVICE TO RELEASE FROM TISSUE. IT WAS REPORTED THE TUBE MAY POSSIBLY BE DAMAGED. IT IS UNKNOWN IF THERE WAS A CONSEQUENCE TO THE PT.
D5;H4: INFORMATION UNAVAILABLE. NOTE: H6; EVALUATION CODE #400(OTHER): DAMAGED FIRING MECHANISM.
THE IAB WAS INSERTED INTO THE PATIENT ON 9/25/96. ON 9/26/96 AFTER IABP FOR ABOUT FOUR DAYS, BLOOD WAS NOTED IN THE CATHETER TUBING AND THE IAB WAS REMOVED BY THE DR. NO SECOND WAS INSERTED BECAUSE THE PATIENT VITAL SIGNS REMAINED STABLE. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE IAB WAS NOT RELEASED BY THE FACILITY. ON 10/31/96, DATASCOPE WAS NOTIFIED BY THE CONTACT IN THE RISK MANAGEMENT DEPARTMENT AT THE FACILITY THAT THE IAB WAS AVAILABLE TO BE RELEASED FOR EVALUATION. ON 10/21/96, DATASCOPE RECEIVED THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT NUMBER: 342303000-1996-26). ON 1/27/97 DATASCOPE WAS NOTIFIED THAT THE IAB WOULD NOT BE RELEASED BY THE FACILITY. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 10/16/96. PATIENT'S CURRENT STATUS: STABLE - RPT'D 10/16/96.
AFTER AN UNDERTERMINED AMOUNT OF TIME USED BLOOD WAS NOTED IN THE TUBING.
H-10-H3 NO CODE 81 HOSP DISCARDED THE SAMPLE. H-11 ALL UNK INFO REQUESTED BUT NOT REC H-11 SECTION F PROVIDED BY MANUFACT.
DURING PHACO-CATARACT SURGERY AND INTRAOCULAR LENS REPLACEMENT, THE SUTURE WAS USED IN INTERRUPTED FASHION FOR CLOSURE OF THE CONJUNCTIVAL FORNIX. ONE DAY POST-OPERATIVELY, SUTURE BREAKAGE REPORTEDLY OCCURRED. NO RESUTURING WAS PERFORMED. SUBSEQUENTLY AT ONE WEEK POSTOPERATIVELY, THE PT COMPLAINED OF IRRITATION TO THE EYE. THE SUTURE WAS THEN REMOVED. NO FURTHER COMPLICATION HAS BEEN REPORTED AND THE PT IS DOING WELL.
INVESTIGATION IS IN PROGRESS. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTION.
THE PT WAS IMPLANTED WITH A SMOOTH SALINE ON 3/22/96. ON 7/26/96 THE PHYSICIAN NOTED THAT THE PT VALVE PROSTHESIS ALONG WITH THE SEAM OF THE DEVICE WAS PALPABLE. NO ADD'L INFO REGARDING THIS OCCURRENCE THE PHYSICIAN NOTED IS AVAILABLE AT THIS TIME.
ADD'L INFO IS TO BE SUBMITTED Y.N? Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "YES" IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN THE LABELING> IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (MENTOR EFFECTIVE DATE, FEBRUARY 10, 1992). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILLING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21 CFR 803. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY; MENTOR H/S EXPERESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS RFEPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO. CO HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. CO DEFERS TO THE PT'S PHYSICIAN AND TO ANY CHARACTERISTICS, REFERENCED IN THE PRODUCT EVALUATION ATTACHED HERETO."
THE IAB WAS INSERTED INTO THE PATIENT ON 10/16/96. AFTER IABP FOR NINE HOURS, THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING AND THE IAB WAS REMOVED.
BASED ON 7/16/96 POST-OP XRAYS, IT WAS DETERMINED THAT PEDICLE SCREW AT L5-S1 LEVEL BROKE. BREAKAGE OCCURRED AT LESS THAN 4 MOS. POST-OP. X-RAYS AT 5/21/96 SHOWED NO BREAKAGE. PT IS DOING WELL. HARDWARE HAS NOT BEEN EXPLANTED.
ADD'L INFO TO BE SUBMITTED? N. IS FREQUENCY OR OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IF YES, THEN IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? NO. IS SEVERITY OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? YES. IF YES, THEN IS THE SEVERITY OF THIS EVENT GREATER THAN LABELED? NO. NO INFO AVAILABLE REGARDING USER FACILITY. A REPORT OR OTHER INFO SUBMITTED BY A REPORTING ENTITY UNDER THIS PART AND ANY RELEASE BY FDA OF THAT REPORT OR INFO, DOES NOT NECESSARILY REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT OR BY FDA THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, OR THE REPORTING ENTITY OR ITS EMPLOYEES OR AGENTS, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE REPORTING ENTITY NEED NOT ADMIT AND MAY DENY (AND EXPRESSLY RESERVES THE RIGHT TO DENY) THAT THE DEVICE, THE PARTY SUBMITTING THE REPORT, OR EMPLOYEES THEREOF, CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
IT WAS REPORTED THAT THE GUIDEWIRE PUNCTURED THE CATHETER APPROX 1 INCH FROM THE TIP. THE CATHETER HAD NOT BEEN PLACED IN A PT.
THE CATHETER ONLY WAS RETURNED FOR EVALUATION. THE STIFFENER STYLET WIRE WAS INSERTED IN THE LUMEN. A TACTILE EXAMINATION OF THE CATHETER TUBING SHOWED NO ELASTIC WEAKENING OR DEFORMATION. THE CATHETER FLUSHED NORMALLY DURING THE INITIAL EVALUATION AND DECONTAMINATION. THE CATHETER LUMEN WAS PRESSURIZED BY ATTACHING A 12CC SYRINGE FILLED WITH WATER TO THE FLUSHING HUB OF THE STIFFENER STYLET. WHEN THE DISTAL TIP WAS OCCLUDED, THE CATHETER LEAKED FROM A TINY PIN HOLE APPROXIMATELY 1" FROM THE DISTAL TIP. THE STYLET WIRE TIP WAS LOCATED 0.35" PROXIMAL TO THE HOLE IN THE CATHETER, AS RECEIVED. UNDER MAGNIFICATION, THE HOLE IN THE TUBING WAS SEMICIRCULAR AND WITHOUT LOOSE FLASH. THE HOLE EDGES WERE GRANULAR, AND THERE WERE NO CROWS FEET TO INDICATE A CUT. IT WAS VERY DIFFICULT TO COMPRESS THE CATHETER TUBING ENOUGH TO CAUSE THE FIRE TIP TO REACH THE LOCATION OF THE HOLE. IT DID APPEAR THAT THE WIRE TIP WOULD FIT THROUGH THE HOLE. THE STIFFENER STYLET WAS REMVOED FROM THE LUMEN AND EXAMINED. THE WIRE TIP WELD APPEARED SMOOTH AND BLUNT. THERE WAS A POINTED BURR ON THE SIDE OF THE TIP WELD. ALTHOUGH THIS BURR MAY HAVE AGGRAVATED THE PUNCTURE, IT WAS NOT THE LIKELY ROOT CAUSE OF THE PUNCTURE. THE TIP OF THE STYLET WIRE APPEARED TO HAVE PUNCTURED THROUGH THE LUMEN WALL, PROBABLY DUE TO AGGRESSIVE ADVANCEMENT OF THE STYLET INTO THE PT. WHEN RESISTANCE IS MET, THE CATHETER SHOULD NOT BE  ADVANCED. THE INSTRUCTIONS FOR USE FOR THIS DEVICE SUGGEST SEVERAL METHODS FOR ASSISTING THE ADVANCEMENT OF THE CATHETER.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE BATCH NUMBER OF THE DEVICE IS NOT ATTAINABLE, THEEFORE A REVIEW OF THE MFG BATCH RECORDS IS NOT POSSIBLE.
THE PORT WAS PLACED 7/18/96 FOR ANTIBIOTICS. ON 9/11/96, THE PT EXPERIENCED PAIN AND DISCOMFORT DURING THE INFUSION. ON 9/30/96, THE PT WENT BACK INTO SURGERY, WHERE THE CATHETER LOCK WAS REMOVED FROM THE PORT STEM. A PINHOLE LEAK ON THE CATHETER WAS NOTED AT THE (SEE H10).
POINT THAT WAS UNDERNEATH THE CATHETER LOCK. THE SURGEON THEN TRIMMED THE CATHETER, AND ATTACHED A NEW PORT AND CATHETER LOCK TO THE CATHETER. THE PORT HAS BEEN RETURNED TO THE MFR AND IS CURRENTLY BEING EVALUATED.
THE CHILD EXPERIENCED AN UNWITNESSED CARDIOPULMONARY ARREST PRIOR TO ARRIVAL AT THE MEDICAL CTR. ON ARRIVAL, THE CHILD WAS PULSELESS AND REMAINED THAT WAY DESPITE RESUSCITATION EFFORTS. ELECTRODES WERE USED FOR CARDIAC MONITORING. AFTER INITIAL PLACEMENT OF THE ELECTRODES, NO RHYTHM WAS SEEN. FURTHER ASSESSMENT DETERMINED THAT THE GEL ON THE BACK OF THE ELECTRODES WAS DRY AND HARDENED. THE ELECTRODES WERE TAKEN FROM AN UNOPENED PACKAGE WITH A CURRENT EXPIRATION DATE. A NEW PACKAGE OF ELECTRODES WAS THEN USED. ALTHOUGH THIS PT DID EXPIRE, THERE WAS NO APPARENT EFFECT TO THE PT AS A RESULT OF THE DEFECTIVE ELECTRODES. INFANT'S WEIGHT 2085 G.
PT WAS HOSPITALIZED WITH A REPORTED BLOOD SUGAR OR 522. PT CLAIMED HER INSULIN PUMP WAS LEAKING AND SHE WAS NOT RECEIVING INSULIN. PROBLEM WAS EVENTUALLY TRACED TO A CRACK IN THE LUER LOCK CONNECTION OF THE ADMINISTRATION SET.
THE PT'S H-TRON INSULIN INFUSION PUMP AND INFUSION SET WERE RETURNED. THE PUMP WAS TESTED, MET ALL SPECIFICATIONS AND WAS RETURNED TO THE PT. VISUAL INSPECTION OF THE INFUSION SET REVEALED THE PLASTIC FEMALE LUER LOCK CONNECTOR THAT ATTACHES TO THE INSULIN CARTRIDGE WAS CRACKED. IT WAS CONCLUDED THAT THE CRACK WAS THE CAUSE OF THE REPORTED LEAK. THE SET HAS BEEN SENT TO THE MFR FOR FURTHER EVALUATION TO DETERMINE THE CAUSE OF THE FAILURE. AS THIS IS THE ONLY REPORT RECEIVED OF THIS TYPE OF FAILURE, NO OTHER ACTION IS PLANNED. A COPY OF THE MFR'S ANALYSIS WILL BE SUBMITTED WHEN RECEIVED. THE CONCLUSION IS THAT THE CRACK IN THE LUER CAUSED THE LEAK OF INSULIN BETWEEN THE PT AND THE PUMP. IT IS FURTHER CONCLUDED THAT THE PT BECAME AWARE THAT THE "PUMP" WAS LEAKING AND DID NOT ATTEMPT TO SECURE AN ALTERNATE SOURCE OF INSULIN (E.G INJECTION). THEREFORE, IT WAS CONCLUDED THAT PT ERROR WAS THE MAJOR CONTRIBUTING FACTOR IN CAUSING THE ADVERSE EVENT (HOSPITALIZATION FOR HIGH BLOOD SUGAR) AFTER THE DEVICE FAILURE. THIS WAS A RETURNED SET THAT CAUSED A LEAK AND PUT THE PT. INTO THE HOSP. WITH A BLOOD SUGAR OF 522.
SPECKS OF BLOOD NOTED IN TUBING OF INTRA-ARTERIAL BALLOON PUMP. SURGEONS NOTIFIED OF POSSIBLE RUPTURED INTRA-ARTERIAL BALLOON. SURGEONS IN TO REMOVE BALLOON VIA EMERGENCY STERNOTOMY IN PT ROOM. BALLOON NOTED TO HAVE A RUPTURE.
EVALUATION CODES FOR SECITON H6: 100 THERE IS DAMAGE PRESENT IN THE WEIGHT BEARING AREAS. THE AFFECTED DIMENSIONS MEET REQUIREMENTS. THE LAB RECORDS INDICATE THE BAR STOCK MEETS REQUIREMENTS. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "N" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADRESSED IN PRODUCT LABELING? NO. IF "N", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNK OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOJT WRITTEN REQUEST.
EVAL OF PUMP SHOWED IT TO BE OPERATING ACCORDING TO PRODUCT SPEC. THE OPERATOR'S MANUAL SUPPLIED WITH THE PRODUCT HAS INSTRUCTIONS ON THE CORRECT WAY TO ATTACH THE RESERVOIR TO THE PUMP AND TO ENSURE THE PUMP AND RESERVOIR ARE SECURELY ATTACHED. THE RESERVOIR INVOLVED IN THE INCIDENT WAS ALSO EXAMINED AND NO PROBLEMS WERE FOUND. MFR COMPLETED PORTIONS OF D6. D7. D8. ALL OF SECTION F. BASELINE REPORT FOR THIS DEVICE FAMILY SUBMITTED 9/12/96.
BOVIE DOES NOT WORK AT TIMES CAUTERIZES INTERMITTENTLY".
THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 10/17/96. BOTH CUT AND COAG MODES CAN BE DE-ACTIVATED WHEN BUTTON IS RELEASED ONLY SLIGHTLY AND DOME HAS NOT BEEN FELT TO "SNAP OPEN." CORRECTIVE ACTION HAS BEEN TAKEN WITH THE SUPPLIER.
SPECKS OF BLOOD WERE NOTED IN THE TUBING OF THE IAB. THE SURGEONS WERE NOTIFIED OF A POSSIBLE LEAK. THE IAB WAS REMOVED VIA AN EMERGENCY STERNOTOMY IN THE PT'S ROOM. CO RECEIVED THIS COMPLAINT ON 10/7/96 VIA THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY; (UF/DIST REPORT #0000050231-1996-0002). THE IAB WAS NOT RETURNED TO CO FOR EVAL. THE IAB WAS NOT RELEASED BY THE FACILITY.
SINCE THE PRODUCT INVOLVED IN THIS EVENT WAS NOT RETURNED OR RELEASED TO CO FOR EVAL, NO ADD'L INFO CAN BE PROVIDED AND THE FILE WILL BE CLOSED. THIS FORM WAS COMPLETED BY THE MFR.
COMPLAINANT STATES THAT THE POLYETHYLENE BEARING INSERT COMPONENT OF THE ACETABULUM PROSTHESIS FAILED NECESSITATING ITS REMOVAL. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES. THE MANUFACTURE DATE COULD NOT BE DETERMINED BECAUSE THE MANUFACTURING LOT NUMBER WAS NOT PROVIDED.
THE FABRIC WAS IMPLANTED IN A PT THAT HAD TESTED NEGATIVE FOR COAGULOPATHY. THE FABRIC HAD BEEN TREATED WITH THROMBIN AS A PRECLOT, RATHER THAN USING THE PT'S UNHEPARINIZED BLOOD TO PRECLOT THE FABRIC. APPROX 700CC OF BLOOD LEAKED THROUGH THE FABRIC BEFORE IT BECAME BLOOD-TIGHT. THE FABRIC WAS LEFT IN. THE PT'S CONDITION IS OK. SINCE THE DR DID NOT PRECLOT THE FABRIC, CONTRARY TO THE INSTRUCTIONS FOR USE, THIS INCIDENT APPEARS TO BE A USER ERROR COMPLAINT.
EXAM AND TESTING OF THE RETURNED FABRICS DID NOT CONFIRM ANY PROBLEM WITH THE POROSITY. THE FABRICS TESTED CORRECTLY, THEIR POROSITY RESULTS BEING WITHIN LABELLED SPEC. NO PRODUCT ERROR IS FOUND. BASED UPON THE DR'S STATEMENT, THE FABRIC WAS NOT PRECLOTTED, CONTRARY TO THE INSTRUCTIONS FOR USE. THEREFORE, THIS EVENT WAS CAUSED BY USER AND IS NOT DEVICE-RELATED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL - NO SIMILAR COMPLAINTS AGAINST THIS BATCH.
RPTR WAS IMPLANTED WITH SALINE BREAST IMPLANTS IN 1/79. ON OCT OF THE SAME YEAR, RPTR HAD TO HAVE SURGERY FOR CAPSULAR CONTRACTURE. RPTR BECAME EXTREMELY ILL IN 1981, AND HAS BEEN DISABLED SINCE 1984, AND ON DISABILITY SINCE AGE 30. RPTR NOW HAS CAPSULAR CONTRACTURE OF THE LEFT BREAST, AND PAINFUL DEFLATED (50%) RIGHT BREAST. RPTR IS NON-FUNCTIONAL MOST OF THE TIME, AND ALSO LOST JOB IN 1985. FAMILY HAS SUFFERED VERY MUCH, ALSO. POST IMPLANTATION: (ALL DIAGNOSED BY MD'S) ARE AS FOLLOWS: HYDRONEPHROSIS OF RIGHT KIDNEY - IMPORTANT FACTORS; SYSTEMIC INFECTIONS THROUGH 1985, AND CHRONIC INFLAMMATORY CHANGES IN PATHOLOGY REPORT OF REMOVED KIDNEY. EXPLORATORY SURGERY FOR EXPLOSIVE ABDOMINAL PAIN IN 1981, AND THEN AGAIN IN 1984, ALSO FOR URINARY INCONTINENCE IN 1984, AND AGAIN IN 1985. INFECTED LYMPH NODE REMOVED IN SUBMENTAL AREA, IN 1987, 2ND REMOVED IN SAME AREA, IN 1989, AND 3RD IS STILL PRESENT IN SAME AREA. IRRITABLE BOWEL, GASTROENTERITIS, INSOMNIA, DEPRESSION, ANXIETY, CHRONIC FATIGUE SYNDROME, EPSTEIN-BARR VIRUS, ESOPHAGITIS, URINARY INCONTINENCE, BOWEL INCONTINENCE, FIBROMYALGIAS, AUTOIMMUNE DISEASE, CONN TISSUE DISEASE, BRONCHITIS, ASTHMA, CHRONIC SINUSITIS, SYSTEMIC INFECTIONS, LYMPHADENITIS, VERTIGO, PHOTOSENSITIVITY, HYPOTHYROIDISM, URTICARIA, HIGH BLOOD PRESSURE, HYPOCHOLESTEROLEMIA, HYPERLIPIDEMIA, MUSKULOSKELETAL PAIN, KELOIDS, CHEMICAL SENSITIVITY, VASCULAR HEADACHES, NEUROPATHY, MYOCLONIC JERKING, DISCOID LUPUS, PSORIATIC ARTHRITIS, HYDRONEPHROSIS, AND BLADDER SPASMS.
THE IAB LEAKED. THAT WAS THE ONLY INFO FROM THE CONTACT AT THE TIME OF THE INITIAL REPORT. THE IAB WAS NOT RETURNED TO CO FOR EVAL. THE IAB WAS NOT RELEASED BY THE RISK MGMT DEPT. EVENT COMPLICATIONS: UNKNOWN-REPORTED 10/17/96. PT'S CURRENT STATUS: UNK-RPT'D 10/17/96.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. SINCE THE PRODUCT INVOLVED IN THIS EVENT WAS NOT RETURNED OR RELEASED TO CO FOR EVAL, NO ADD'L INFO CAN BE PROVIDED AND THE FILE WILL BE CLOSED. ANY ADD'L INFO RECEIVED BY CO WILL BE SUBMITTED. (LABEL CODE: 1738)
WHEN THE IAB WAS INSERTED, THERE WAS BLEEDING FROM THE CLEAR HEMOSTASIS VALVE. IABP CONTINUED WITHOUT ANY FURTHER PROBLEMS. THE HEMOSTASIS VALVE WAS NOT UNSCREWED FROM THE DILATOR.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVAL. THE ITEM WAS DISCARDED. THIS FILE IS CONSIDERED CLOSED. THIS FORM WAS COMPLETED BY MFR.
ON 10/21/96, THE PT CONTACTED A MFR NURSE AND REPORTED THAT THE DEVICE HAD "FLIPPED" SHORTLY AFTER IMPLANT. IT WAS ADDITIONALLY STATED THAT THE DEVICE WAS REPOSITIONED AND RESUTURED BY THE PHYSICIAN ON 7/18/96. THE PT STATED THAT THE PHYSICIAN INFORMED HER THAT THE DEVICE WAS ONLY SECURED BY ONE SUTURE ORIGINALLY, BUT THAT THE DEVICE WAS SECURED WITH ADD'L SUTURES WHEN IT WAS REPOSITIONED. THERE WAS NO PROBLEM UNTIL 10/3/96 AND 10/7/96 WHEN THE PT EXPERIENCED BURNING AND SWELLING AT THE DEVICE SITE SHORTLY AFTER CHEMO INFUSION. THE PT STATES THAT HER ONCOLOGIST HAS SUGGESTED HAVING A VENOGRAM PERFORMED AND INQUIRED WHETHER THIS WAS APPROPRIATE. THE MFR NURSE INFORMED THE PT THAT A VENOGRAM IS AN APPROPRIATE STUDY TO EVALUATE HER REPORT. THE PT STATED THAT SHE DID NOT WANT HER PHYSICIANS CONTACTED AND THAT SHE WOULD CONTACT THE MFR NURSE WITH THE FOLLOW-UP INFO.
FURTHER COMMUNICATION WITH THE PT, ON 11/7/96, REVEALED THAT A DYE INJECTION OF THE DEVICE UNDER FLUOROSCOPY SHOWED "NOTHING WAS WRONG WITH THE CATHETER". THE PT CONTINUES TO HAVE DISCOMFORT IN THE AREA OF THE DEVICE, INCLUDING A "BURNING" SENSATION WHEN THE DEVICE IS INJECTED. THE PT IS BEING EVALUATED TO R/O METASTASIS OF HER CANCER AS THE CAUSE OF THE DISCOMFORT. THE LOCATION OF THE SUTURES SECURING THE DEVICE WERE VISUALIZED DURING A CT SCAN, AND THE PHYSICIAN IS CONSIDERING IF THE POSITION OF THE SUTURES IS RELATED TO HER DISCOMFORT. THE PT IS NOW BEING EVALUATED BY HER PHYSICIANS AND REQUESTS THAT THEY NOT BE CONTACTED. THE PT WILL HAVE HER PHYSICIANS CONTACT CO IF THEY HAVE ANY QUESTIONS CONCERNING THE EVENT. THE MFR NURSE HAS RECOMMENDED THAT THIS FILE BE CLOSED SINCE THE CAUSE OF THIS EVENT DOES NOT APPEAR TO BE DUE TO THE DEVICE OR A DEVICE MALFUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
OVEN STERILIZER IN USE WITH 15 DIALYZERS INSIDE WHEN THE UNIT OVERHEATED. OVEN RUINED BEYOND REPAIR, ALL DIALYZERS RUINED AS WELL AS GRAPH RECORDER. COST TO FACILITY WILL BE IN EXCESS OF $ 3,500. DUE TO HEAVY SMOKE IN THE BUILDING FIRE DEPT ARRIVED. NO FIRE BUT HEAVY SMOKE. WILL OFFER TO RETURN UNIT TO CO. IT IS AVAILABLE.
THE CLEAR HEMOSTASIS VALVE LEAKED PRIOR TO IAB INSERTION. THE USER DID NOT UNSCREW THE HEMOSTASIS VALVE FROM THE SHEATH.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738. DEVICE LABEL CODE FOR F10. POSITION 2: 1738.
THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER. THE DR HAD DIFFICULTY REMOVING THE IAB FROM THE PT. EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 10/17/96. PT'S CURRENT STATUS: UNK-RPT'D 10/17/96.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAIALBE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE BATCH NUMBER OF THE DEVICE IS NOT ATTAINABLE, THEREFORE, A REVIEW OF THE MFG BATCH RECORDS IS NOT POSSIBLE.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVAL. THE ITEM WAS DISCARDED. THIS FILE IS CONSIDERED CLOSED. THIS FORM WAS COMPLETED BY THE MFR.
DEVICE WAS PACING PT'S HEART. STAFF MEMBER STOPPED THE DEVICE, BUT DEVICE KEPT PACING AT A FASTER RATE THAN THE SET RATE.
IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE MAGNET DEVICE DID NOT HOLD THE GUIDE WIRE IN PLACE. WIRE POSITION WAS LOST AND ANOTHER WIRE COULD NOT BE POSITIONED. THE PT WENT INTO BYPASS SURGERY. PT STATUS IS LISTED AS "OK".
THE DEVICE WAS DISCARDED BY THE HOSP, SO NO RETURNED PRODUCT ANALYSIIS WILL BE AVAILABLE.
COMPLAINANT STATES THAT THE POLYETHYLENE BEARING INSERT COMPONENT OF THE ACETABULUM PROSTHESIS FAILED. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. THE EXACT SIZE IS UNK BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED. THE MANUFACTURING LOT NUMBER WAS NOT PROVIDED TO CO. THE MANUFACTURE DATE IS NOT KNOWN BECAUSE THE MANUFACTURING LOT NUMBER WAS NOT PROVIDED TO CO.
PT APPARENTLY RECEIVED A BURN ON THE CHIN, APPROX SIZE OF A DIME. PHYSICIAN AND STAFF NOTICED A SPARK. CLINICAL ENGINEER INSPECTED AND FOUND EXPOSED METAL ON FORCEP.
CHECK "IAB CATH" ALARM SOUNDED FROM THE SYSTEM PUMP. THE PUMP WAS CHANGED TO ANOTHER SYSTEM, THEN THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING. EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 10/17/96. PT'S CURRENT STATUS: UNK-RPT'D 10/17/96.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECIEVED FROM THE INITIAL REPORTER OR PRODUCT USER. EVALUATION SUMMARY: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
CODE 86: EVAL OF EVENT BASED ON MFG AND QC PROCEDURES AND HISTORICAL USE OF DEVICE RELATED TO THIS EVENT. THIS INFO WAS PROVIDED TO A CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. SEVERAL ATTEMPTS TO GAIN FURTHER INFO HAVE BEEN UNSUCCESSFUL. HOWEVER, IF WAS REPORTED THAT DEVICE WAS USED UNEVENTFULLY FOLLOWING A CARDIAC CATHETERIZATION PROCEDURE. THREE DAYS FOLLOWING THE PROCEDURE, THE PT PRESENTED WITH AN INFECTION IN THE    GROIN SITE. THE PT WAS HOSPITALIZED FOR DEBRIDEMENT AND ANTIBIOTICS. CULTURE WAS POSITIVE FOR S AUREUS. CODE 68: PRODUCT IS ASSUMED TO BE STERILE BASED ON MFG AND QC PROCEDURES. ATTRIBUTE INFECTION TO INADVERTENT CONTAMINATION DURING OR AFTER PROCEDURE.
IMPLANTED CATHETER BECAME DISCONNECTED FROM RESERVOIR AND MIGRATED IN VESSELS. TIP IN HEART (RT VENTRICLE) REQUIRED REMOVAL. NO COMPLICATIONS.
PATIENT'S CURRENT STATUS: UNK - RPT'D 10/8/96.
THE IAB LEAKED. THAT WAS THE ONLY INFO FROM THE CONTACT AT THE TIME OF THE INITIAL REPORT. EVENT COMPLICATIONS: UNKNOWN-REPORTED 10/18/96. PT'S CURRENT STATUS: UNK RPT'D 10/18/96.
(THIS MDR WAS MAILED TO THE FDA ON 7/8/97). DEVICE LABEL CODE FOR F10. POSITION 1: 1738. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBALBE CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECTED TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILATES. D.1-CORRECT BRAND NAME IS HYLAMER LINER, 28MM, 10 DEGREE, 48 OD. D.9. DEVICE WAS NOT RETURNED TO THE MANUFACTURER.
REPORTED THAT THE "BOVIE CUT IN AND OUT".
THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 10/17/96. BOTH CUT AND COAG MODES CAN BE DE-ACTIVATED WHEN BUTTON IS RELEASED ONLY SLIGHTLY AND DOME HAS NOT BEEN FELT TO "SNAP" BACK OPEN. CORRECTIVE ACTION HAS BEEN TAKEN WITH THE SUPPLIER.
HOSP CHIEF CT TECH REPORTED APPROX. 20CC OF AIR WAS INJECTED INTO PT VIA A LF INJECTOR USING A 125ML PREFILLED SYRINGE. PT WAS OBSERVED FOR 2 HRS AND CT SCAN WAS REDONE. CHIEF CT TECH FELT CERTAIN THAT THE AIR INJECTION WAS A RESULT OF OPERATOR ERROR DUE TO NURSE NOT REPLACING THE USED PREFILLED SYRINGE FROM PREVIOUS PROCEDURE WITH A NEW PREFILLED SYRINGE. PT WAS REPORTED IN GOOD PHYSICAL SHAPE. LF SERVICE REP. EVALUATED INJECTOR ON 10/9/96 AND FOUND IT TO BE FUNCTIONING PROPERLY. LF SALES REP PERFORMED IN SERVICE FOR 15 HOSP STAFF ON 10/16/96.
NEITHER THE SUBMISSION OF THIS OR OTHER INFO TO THE FDA PURSUANT TO 21 CFR 803 NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT THIS DEVICE IS DEFECTIVE OR ESTABLISHES THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN THIS DEVICE AND A DEATH OR SERIOUS INJURY. MFR RECEIVED NO MEDWATCH FORM FROM HOSP; THEREFORE, SECTIONS A,C,AND F ARE NOT KNOWN AND LEFT BLANK.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY FOLDED. BLOOD WAS NOTED ON THE EXTERIOR OF THE IAB AND WITHIN THE INNER LUMEN. THE SHEATH USED WITH THE IAB WAS ALSO RETURNED. THE SHEATH WAS NOT IN PLACE OVER THE CATHETER TUBING. THE SHEATH I.D. AND CATHETER O.D. WERE MEASURED AND FOUND TO BE WITHIN DATASCOPE'S MFG SPECIFICATIONS. THE FOLDED MEMBRANE APPEARED NORMAL UNDER ROOM LIGHT AND POLARIZED LIGHT. AS A TEST, A VACUUM WAS DRAWN ON THE FOLDED MEMBRANE USING A LABORATORY 60CC SYRINGE AND THE RETURNED ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH THE RETURNED 10 FRENCH, 6 INCH SHEATH WITHOUT ANY DIFFICULTIES. PROBABLE CAUSE OF DIFFICULTY: NO DEFECTS WERE FOUND IN THE FOLDED MEMBRANE OR IN THE RETURNED SHEATH BASED ON THE EXAMINATION. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTY IN THE LAB. IN GENERAL, DIFFICULTY ADVANCING THE IAB INTO THE SHEATH MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: THE USER MAY HAVE NOT DRAWN A SUFFICIENT VACUUM ON THE BALLOON DURING ITS REMOVAL FROM THE BLISTER TRAY. IF DRAWN, A VACUUM MAY HAVE NOT BEEN MAINTAINED THROUGHOUT THE INSERTION PROCEDURE. DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. THE PATIENT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO THE SHEATH. DURING IAB INSERTION, THE BALLOON TIP MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY AS IT EXITED THE END OF THE SHEATH.
EVENT COMPLICATIONS: UNK - REPORTED 10/8/96; NONE - REPORTED 10/31/96. PATIENT'S CURRENT STATUS: TRANSFERRED - RPT'D 10/31.
CHECK "IAB CATH" ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED AND A SECOND WAS INSERTED. EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 10/21/96. PT'S CURRENT STATUS: STABLE-RPT'D 10/21/96.
DEVICE LABEL CODES: 1701, 1738. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE IAB MEMBRANE. UNDER MICROSCOPY, A SMOOTH AND SQUARE EDGED PENETRATION WAS SEEN AT THE LEAK SITE. PROBABLE CAUSE OF DIFFICULTY: THE PHYSICAL EVIDENCE INDICATES THAT THE SOURCE OF THE BALLOON LEAK WAS A PENETRATION OF THE MEMBRANE PROBABLY CAUSED BY CONTACT WITH A SHARP EDGED OBJECT. THE MEMBRANE DAMAGE MAY HAVE OCCURRED PRIOR TO OR DURING BALLOON INSERTION.
A 6.5 MM CANCELLOUS SCREW WITH WASHER WAS IMPLANTED ON 12/2/95. IT WAS REMOVED BECAUSE IT WAS BROKEN INSIDE THE BONE. THE DISTAL END OF THE SCREW WAS LEFT IN THE BONE. IT COULD NOT BE RETRIEVED. ON 4/96 PT HAD SOMETHING FALL ON HIS LEFT SHOULDER AT WORK. LEFT SHOULDER - OPERATIVE SIDE.
DURING AN ATTEMPTED IMPLANT, THE PT WAS INDUCED INTO VF. THE ICD DETECTED THE ARRHYTHMIA, DISCHARGED AND WAS FOLLOWED BY A POPPING NOISE. THE DEVICE DID NOT RECHARGE. THE PT WAS RESCUED BY EXTERNAL DEFIBRILLATION. NO FURTHER COMMUNICATIONS WITH THE ICD COULD BE ESTABLISHED.
H.3 EVALUATION SUMMARY: THE REPORTED EVENT HAS BEEN CONFIRMED. ANALYSIS REVEALED DAMAGE OT THE OUTPUT MODULE. IT IS BELIEVED THAT A BREAKADOWN IN THE OUTPUT MODULE OCCURRED DURING THE DELIVERY OF HIGH VOLTAGE THERAPY, RESULTING IN A LOW IMPEDANCE PATH. THE DELIVERY INTO THIS LOW IMPEDANCE PATH RESULTED IN DAMGE TO THE PROTECT CIRCUIT AND SEVERAL SURROUNDING COMPONENTS. THE METHOD OF BREAKDOWN COULD NOT BE CONCLUSIVELY DETERMINED.
PT HAD A RIGHT SUBCLAVIAN CATHETER PLACED ON 9/24/96 WHICH FUNCTIONED WITHOUT DIFFICULTY UNTIL REMOVE WAS REQUIRED ON 10/2/96 DUE TO AN IV INFILTRATION TO HIS RIGHT CHEST/SHOULDER AREA. (AMPHETER. B AND PRBC WERE INFUSING AT THE TIME). FLUOROSCOPY WAS PERFORMED PRIOR TO REMOVAL. EXTRAVASATION AROUND THE MEDIALLY LOCATED PORT WAS NOTED WHEN THE MEDIAL CATHETER NEEDLE WAS INJECTED WITH CONTRAST. IT APPEARED THAT THE PORT MEMBRANE HAD DISLODGED FROM THE PORT ON THE MEDIAL SITE. THE MORE LATERALLY POSITIONED PORT WAS NOTED TO BE INTACT WITH FREE FLOW OF CONTRAST THROUGH THE CATHETER AND INTO THE RIGHT ATRIUM. THIS CATHETER WAS REMOVED. IT WAS REPLACED WITH A DIFFERENT CATHETER INTO THE LEFT SUBCLAVIAN VEIN.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY FOLDED. BLOOD WAS NOTED ON THE EXTERIOR OF THE IAB AND WITHIN THE INNER LUMEN. THE SHEATH USED WITH THE IAB WAS ALSO RETURNED. THE SHEATH WAS NOT IN PLACE OVER THE CATHETER TUBING. THE SHEATH I.D. AND CATHETER O.D. WERE MEASURED AND FOUND TO BE WITHIN DATASCOPE'S MFG SPECIFICATIONS. THE FOLDED MEMBRANE APPEARED NORMAL UNDER ROOM LIGHT AND POLARIZED LIGHT. AS A TEST, A VACUUM WAS DRAWN ON THE FOLDED MEMBRANE USING A LABORATORY 60 CC. SYRINGE AND THE RETURNED ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH THE RETURNED 10 FRENCH, 6 INCH SHEATH WITHOUT ANY DIFFICULTIES. PROBABLE CAUSE OF DIFFICULTY: NO DEFECTS WERE FOUND IN THE FOLDED MEMBRANE OR IN THE RETURNED SHEATH BASED ON THE EXAMINATION. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTY IN THE LAB. IN GENERAL, DIFFICULTY ADVANCING THE IAB INTO THE SHEATH MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: THE USER MAY HAVE NOT DRAWN A SUFFICIENT VACUUM ON THE BALLOON DURING ITS REMOVAL FROM THE BLISTER TRAY. IF DRAWN, A VACUUM MAY HAVE NOT BEEN MAINTAINED THROUGHOUT THE INSERTION PROCEDURE. DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. THE PATIENT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO THE SHEATH. DURING IAB INSERTION, THE BALLOON TIP MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY AS IT EXISTED THE END OF THE SHEATH.
WHEN THE IAB WAS INSERTED INTO THE PT WITH A SHEATH AND GUIDEWIRE IN PLACE, BLOOD CAME OUT OF THE WHITE HEMOSTASIS VALVE. IABP CONTINUED WITHOUT FURTHER PROBLEMS. NO ADD'L INFO WAS AVAILABLE FROM THE CONTACT. EVENT COMPLICATIONS: UNK-REPORTED 10/14/96. PT'S CURRENT STATUS: UNK-RPT'D 10/14/96.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. SINCE THE PRODUCT INVOLVED IN THIS EVENT WAS NOT RETURNED TO CO FOR EVAL, THE FILE WILL BE CLOSED. THE DEVICE WAS SUCCESSFULLY USED ON THE PT AND WILL NOT BE RETURNED. (LABEL CODE: 1701)
REPORTED THAT THE "BOVIE CUTS IN AND OUT WORKS HALF THE TIME".
THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 10/17/96. THE CUT MODE TESTED FINE. THE COAG MODE CAN BE DE-ACTIVATED WHEN BUTTON IS RELEASED ONLY SLIGHTLY AND DOME HAS NOT BEEN FELT TO "SNAP" BACK OPEN. CORRECTIVE ACTION HAS BEEN TAKEN WITH THE SUPPLIER.
SYRINGE WAS USED TO FLUSH A VENOUS CENTRAL LINE. WHEN THE RN ATTEMPTED TO PULL THE SHEATH UP OVER THE NEEDLE, THE NEEDLE STUCK, RESULTING IN AN ACCIDENTAL NEEDLE STUCK TO THE NURSE. THE NURSE REPORTED THE INCIDENT. MEDICAL ATTENTION WAS PROVIDED TO THE NURSE. ALSO, AN APPROPRIATE IAB TEST WAS DRAWN FROM THE PT.
A PLASTIC DUAL LUMEN PORT WITH ATTACHABLE OPEN-ENDED CATHETER WAS RETURNED FOR EVAL. THE LEFT-SIDE PORT SEPTUM WAS MISSING. THE USER FACILITY INDICATED THAT DURING THE DECONTAMINATION PROCESS PRIOR TO RETURN TO THE MFR THAT THE PARTIALLY DISLODGED PORT SEPTUM HAD COME COMPLETELY OUT OF THE PORT AND WAS MISSING. VISUALLY, THE LEFT SIDE SEPTUM SEAT SHOWED NO ABNORMALITIES OR IMPERFECTIONS. THE LUMEN WAS VERIFIED TO BE PATENT WHEN IT WAS FLUSHED USING A BLUNT CONNECTOR ATTACHED TO A 12CC SYRINGE FILLED WITH WATER INSERTED IN THE DISTAL TIP OF THE CATHETER. THE FLOW WAS DIRECTED BACK TOWARD THE PORT RESERVOIR WITH THE MISSING SEPTUM. THE RIGHT SIDE LUME WAS ALSO VERIFIED TO BE PATENT WHEN THE SEPTUM WAS ACCESSED WITH A NON-CORING NEEDLE ATTACHED TO A 12CC SYRINGE. SOME BLOOD CLOTS WERE FLUSHED FROM THE RIGHT SIDE LUMEN. NO LEAKS WERE NOTICED WHEN THE LUMEN WAS PRESSURIZED BY OCCLUDING THE DISTAL TIP WITH FINGER PRESSURE. IT APPEARED THAT THE LEFT SIDE LUMEN WAS OVERPRESSURIZED WHICH CAUSED THE SEPTUM TO BE LIFTED FROM ITS SEAT. TYPICALLY, INTERNAL PRESSURES IN EXCESS OF 150 PSI ARE REQUIRED TO DISLODGED THE SEPTUM FROM ITS SEAT. A SYRINGE SMALLER THAN 10CC CAN EASILY GENERATE THIS LEVEL OF PRESSURE IN AN OCCLUDED LUMEN. A LOT REVIEW INDICATED THAT THIS LOT PASSED 100% PRESSURE TESTING DURING MANUFACTURE. THE USER FACILITY INDICATED THAT "PACKED BLOOD CELLS" WERE BEING INFUSED BEFORE THE SEPTUM RUPTURED, AND BLOOD RESIDUE WAS NOTICED INSIDE THE DISTAL END OF THE LUMEN AFTER FLUSHING AND DECONTAMINATION. IT IS POSSIBLE THAT THE LUMEN MAY HAVE BEEN RESTRICTED BY BLOOD CLOTTING, WHICH COULD HAVE LED TO THE OVERPRESSURIZED CONDITION. ADDITIONALLY, A LUMEN CAN BECOME CLOGGED IF IT IS NON PROPERLY MAINTAINED THROUGHOUT THE DURATION OF USE. CHEMICALS ARE AVAILABLE TO CLEAR BLOCKED LUMENS.
DEVICE LABEL CODE FOR F10. POSITION 1: 1701.
WHEN THE IAB WAS REMOVED FROM THE BLISTER TRAY, ONE OF THE RETAINERS REMAINED ON THEIAB. INSPITE OF SEVERAL CALLS TO THE FACILITY, THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVALUATION. EVENT COMPLICATIONS: UNK - REPORTED 10/8/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 10/8/96.
THIS WAS PT'S SECOND REACTION. THE PT'S SECOND REACTION WAS THE SAME AS THE PT'S FIRST REACTION AS DESCRIBED IN MFR'S REPORT #9681834-1996-00022. DIFFERENT DIALYZER, SAME LOT AS FIRST. WAS REPROCESSED, RINSED WITH 2000 ML SALINE PLUS 10 ML OF PT'S OWN BLOOD INJECTED INTO SALINE. 10-15 MINUTES INTO DIALYSIS, PT EXPERIENCED CHEST TIGHTNESS, SHORTNESS OF BREATH, ANXIETY, AND BACK PAIN. DIALYSIS STOPPED AND BLOOD NOT RETURNED. EBL-325 ML. OVER THE TWO DAYS, THE PT'S HEMATOCRIT DROPPED FROM 34% TO 31%. PT IS OKAY. PT DID NOT REQUIRE TRANSFUSION. PT RETURNED TO A COMPETITOR'S BRAND OF DIALYZERS. 'S
SAMPLES FROM THE SAME LOT WERE RETURNED AND TESTED FOR PRYOGEN, ACUTE SYSTEMIC TOXICITY, INTRACUTANEOUS TOXICITY, AND HEMOLYSIS; ALL RESULTS WERE NORMAL. THE ROUTINE MFG QUALITY TEST RESULTS WERE REVIEWED FOR BIOLOGICAL TESTS AND STERILITY TESTS; ALL RESULTS WERE NORMAL. NO CAUSE FOR THIS INCIDENT COULD BE IDENTIFIED.
THE ONE-WAY VALVE WAS ATTACHED TO AN END OF THE EXTENSION TUBING, AND BECAUSE OF THAT, THE DR COULD NOT CONNECT THE TUBING TO THE PUMP.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. A SYSTEM 90 EXTENDER TUBING WAS RECEIVED FOR EVALUATION (FOR USE WITH A 25 CC IAB). VISUAL EXAMINATION REVEALED A ONE-WAY VALVE ON THE END OF THE EXTENDER TUBING IN PLACE OF THE MALE LUER. THE ONE-WAY VALVE WAS TIGHTLY SEATED IN THE TUBING END. PROBABLE CAUSE OF DIFFICULTY: LABORATORY EXAMINATION VERIFIED THE REPORTED DIFFICULTY. ALTHOUGH IT IS NOT POSSIBLE TO DETERMINE EXACTLY WHEN THIS OCCURRED, THE APPOPRIATE INDIVIDUALS AT DATASCOPE HAVE BEN MADE AWARE OF THIS COMPLAINT. THE LINE OPERATORS RESPONSIBLE FOR ASSEMBLING THIS EXTENDER TUBING WILL BE SHOWN THE TUBING AND THE REPORTED COMPLAINT. IT IS WORTH NOTING THAT A ONE-WAY VALVE IS PACKAGED WITH AN IAB IN ITS BLISTER TRAY. THIS PACKAGING IS DONE IN A SEPARATE AREA FROM WHERE EXTENDER TUBINGS ARE ASSEMBLED AND PACKAGED INTO INSERTION KITS. THERE ARE NO ONE-WAY VALVES IN THE COMPONENT ASSEMBLY AREA. THE INSERTION KIT LINES DO NOT USE ONE-WAY VALVES IN ANY KITS.
PT HAS DEVELOPED CONTACT DERMATITIS, RASH, RUNNY NOSE AND EYES AFTER USING LATEX GLOVES. BUT AFTER EXPERIENCING BREATHING DIFFICULTIES ON THE JOB, SHE WENT TO SEE AN ALLERGIST. PT WENT INTO ANAPHYLACTIC SHOCK DURING TESTING. SHE WAS PRESCRIBED MEDICATION AND TOLD THAT SHE HAD SEVERE ASTHMA. PT CAN NO LONGER WORK AS A NURSE AND IS CURRENTLY ON WORKMAN'S COMP.
THE "HELIUM GAS LEAK" ALARM SOUNDED FROM THE SYSTEM PUMP AND THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER. THE IAB WAS NOT RETURNED TO CO FOR EVAL. THE IAB WAS DISCARDED BY THE FACILITY. EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 10/21/96. PT'S CURRENT STATUS: UNK-RPT'D 10/21/96.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVAL. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. ANY ADD'L INFO RECEIVED BY CO WILL BE REPORTED. (LABEL CODE: 1738)
REPORTED THAT "YELLOW BOVIE HANDLE MALFUNCTIONED. WAS ON IN COAG WHEN NOT BEING DEPRESSED".
THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 10/17/96. CUT AND COAG MODES TESTED FINE. NO EVIDENCE OF PRODUCT DEFECT WAS NOTED.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHCOEMULSIFICATIOIN HANDPIECE WOULD NOT PHACO. THE HANDPIECE WAS DISCONNECTED AND RECONNECTED AND IT THEN WAS ABLE TO BE USED. THE PROCEDURE WAS DELAYED APPROX 15 MINUTES.
PATIENT'S CURRENT STATUS: STABLE - RPT'D 10/31/96.
THERE WAS A REPORTED PULMONARY ARTERY RUPTURE 48 HRS AFTER SURGERY ON 10/19/96. THE PT STARTED THROWING UP BLOOD. IT WAS REPORTED THAT THE PT WAS STABILIZED. THE PHYSICIAN STATED IT IS UNK IF THE PULMONARY ARTERY RUPTURE WAS ATTRIBUTED TO THE CATHETER.
DIALYZER FIRST USE, PREPROCESSED WITH REPROCESSING SOLUTION. DIALYZER WAS FLUSHED WITH 2000ML SALINE PLUS 10 ML OF PT'S OWN BLOOD INJECTED INTO SALINE. IT WAS FIRST TIME PT HAD USED DIALYZER WITH CELLULOSE FIBERS. DIALYSIS STOPPED; THE BLOOD WAS NOT RETURNED. EBL-350 ML. PT IS OKAY; DID NOT REQUIRE TRANSFUSION. PT RETURNED TO A COMPETITOR'S BRAND OF DIALYZERS.
SAMPLES FROM THE SME LOT WERE RETURNED AND TESTED FOR PYROGEN, ACUTE SYSTEMIC TOXICITY, INTRACUTANEOUS TOXICITY, AND HEMOLYSIS; ALL RESULTS WERE NORMAL. THE ROUTINE MFG QUALITY TEST RESULTS WER REVIEWED FOR BIOLOGICAL TESTS AND STERILITY TESTS; ALL RESULTS WERE NORMAL. NO CAUSE FOR THIS INCIDENT COULD BE IDENTIFIED.
THE IAB WAS INSERTED INTO THE PATIENT ON 9/28/96. ON 10/4/96, A SMALL LEAK WAS NOTED AND THE IAB WAS REMOVED. NO SECOND WAS INSERTED. ON 1/17/97, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 10/7/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 10/7/96.
NONE REPORTED. THE HOSP WAS CONTACTED AND NO FURTHER INFO ABOUT THIS DEVICE WAS AVAILABLE.
PRODUCT WAS BEING USED ON A PT WHO GOT OUT OF BED, FELL AND FRACTURED HER RIGHT HIP AND RIGHT WRIST. THE STAFF NEVER HEARD THE PRODUCT SOUND.
THIS REPORT IS BASED ON INFO SUPPLIED TO CO WITHOUT CO'S INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS OR RELATIONSHIP TO THE PRODUCT. CO IS JUST RESPONDING TO THIS EVENT AS REQUIRED BY LAW. CO IS ATTEMPTING TO HAVE THE DEVICE RETURNED TO CO SO THAT WE MAY EVALUATE IT.
THE SURGEON  USED MEMBRANE FOLLOWING A LUMBAR LAMINECTOMY. THREE MONTHS POSTOPERATIVELUY THE SURGEON REOPERATED BECAUSE OF ONGOING SYMPTOMS. HE FOUND MEMBRANE HAD HARDENED AND HAD A CENTRAL FOLD WHICH CAUSES DISCRETE COMPRESSION ONTO THE POSTERIOR ASPECT OF THE THECAL SAC. THE SURGEON EXPLANTED THE MEMBRANE.
THE DEVICE WAS NOT RETURNED TO CO FOR EVALUATION; THEREFORE, NO CODES WERE COMPLETED FOR METHOS AND RESULTS.
HEALTHCARE PROFESSIONAL STATED VALVE WAS REMOVED DUE TO CALCIFICATION AND CUSPAL TEARS. DEVICE HAD BEEN IMPLANTED 139 MONTHS. PT AGE AT IMPLANT 63. THE VALVE WAS RETURNED FOR ANALYSIS.
THIS REPORT IS A FOLLOW-UP TO THE INITIAL REPORT TO NOW INCLUDE THE 3500A REPORT RECEIVED FROM THE USER FACILITY ON 11/26/96. H11. CODES: DEVICE CODE #2379 - LABELED.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION INSPITE OF NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR THE RETURN OF THE PRODUCT.
THE DR HAD DIFFICULTY REMOVING THE IAB FROM THE PT. NO LEAK WAS RPT'D. INSPITE OF SEVERAL CALLS TO THE FACILITY, THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVALUATION. EVENT COMPLICATIONS: UNK - RPT'D 10/9/96. PT CURRENT STATUS: UNK - RPT'D 10/9/96.
EVAL SUMMARY FROM H.3. ASPIRATION LINE WAS TESTED IN A MICROSURGICAL SYSTEM AND DEFECT WAS CONFIRMED.
THE DEVICE WAS BEING UTILIZED TO DILATE A DIALYSIS GRAFT. THE BALLOON HAD BEEN INFLATED AND DEFLATED SIX TO SEVEN TIMES WHEN ATTEMPTED DEFLATION WAS NOT SUCCESSFUL. THE PHYSICIAN PUNCTURED THE BALLOON BY INSERTING A NEEDLE INTO THE ARM AND THROUGH THE VEIN GRAFT. THE BALLOON CATHETER WAS THEN REMOVED. THE PT DID NOT SUSTAIN ANY ADVERSE EFFECT FROM THIS EVENT.
A. 1,2,3,4) INFO WAS NOT AVAILABLE. B. 3) INFO WAS NOT AVAILABLE. D. 5) UNABLE TO DETERMINE WITHOUT LOT #. 6) LOT#-INFO WAS NOT AVAILABLE. F. 9) UNABLE TO DETERMINE WITHOUT LOT# 6) INFO WAS NOT AVAILABLE. H. 4) UNABLE TO DETERMINE WITHOUT LOT#. THE RETURNED, USED DEVICE WAS EXAMINED AND THE BALLOON LUMEN WAS FOUND TO BE PUNCTURED AND ENCRUSTED WITH BLOOD. THE INFLATION/DEFLATION LUMEN OPENING WAS EXAMINED AND NO PROBLEMS WERE NOTED. UNFORTUNATELY, DUE TO THE CONDITION OF THE RETURNED DEVICE A MORE THOROUGH EVAL WAS NOT POSSIBLE. UNFORTUNATELY, FROM THE AVAILABLE INFO, CO IS UNABLE TO DETERMINE WHY DIFFICULTY WAS ENCOUNTERED.
THE DILATATION CATHETER WAS USED TO POST DILATE A STENT. THE PHYSICIAN MET RESISTANCE BUT PROCEEDED TO PLACE THE DILATATYION CATHETER INTO THE STENT. THE PHYSICIAN FOUND IT DIFFICULT TO INFLATE THE BALLOON. THE INFLATION ISSUE WAS DUE TO THE PROTECTIVE SHEATH BEING LEFT ON  THE BALLOON. HE REMOVED THE SYSTEM BUT THE SHEATH REMAINED IN THE ARTERY AND THE PT WENT TO SURGERY TO HAVE IT REMOVED. PT IS REPORTEDLY DOING WELL POST OPERATIVELY.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSP OR DISTRIBUTER. THE BALLOON WOULD NOT INFLATE DUE TO THE SHEATH BEING LEFT ON THE BALLOON. THE SHEATH THEN REMAINED IN THE BODY WHEN THE SYSTEM WAS REMOVED. IT IS STATED IN THE INSTRUCTIONS FOR USE TO REMOVE THE PROTECTIVE SHEATH DURING PREPARATION OF THE BALLOON. TO ENSURE REMOVAL OF THE SHEATH A COLOR CHANGE OF THE SHEATH IS BEING EVALUATED. QUALITY ASSURANCE CONTINUES TO MONITOR THE DEVICE FOR THIS TYPE OF COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPT.
PLUGGED IN PENCIL AND IT WAS ALREADY 'ON' IN THE COAG MODE.
MFG INFORMED. CORRECTIVE ACTION WAS TAKEN. THE LOT # THAT WAS PROVIDED BY THE DISTRIBUTOR DOES NOT MATCH THE PRODUCT THAT WAS REC'D. CO KNOWS THAT IT WAS MANUFACTURED PRIOR TO THE 7/96, DUE TO THE CORDSET ON THE PENCIL. THE CORRECT LOT # IS NOT KNOWN. THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 10/22/96. CO WAS UNABLE TO CONFIRM OR DUPLICATE THE PERFORMANCE PROBLEM. IT WAS NOTED THAT WHEN THE PENCIL WAS DISASSEMBLED, SMALL CUT WIRES WERE FOUND UNDERNEATH THE SILICONE SLEEVE ON THE PRINTED CIRCUIT BOARD. CORRECTIVE ACTION HAS BEEN TAKEN.
A LENS REPLACEMENT AND A MILD ANTERIOR VITRECTOMY WERE PERFORMED DUE TO RECURRENT HYPHEMA. THE PHYSICIAN FELT THIS TO BE PRODUCT RELATED.
A4: ACCOUNT UNABLE TO PROVIDE INFO. F10: PAT CODE: 1911, LABELED. DEVICE CODE: 2184, LABELED; 2203=VITRECTOMY, LABELED. H6: METHOD: 86=PRODUCT NOT RETURNED FOR EVAL.
THE PT WAS PRESENTED WITH VESSEL DISEASE OF THE MID LAD AND THE PROXIMAL DIAGONAL. THE DIAGONAL WAS PREDILATED AND A 12MM STENT SUCCESSFULLY DEPLOYED. A SECOND STENT WAS THEN DEPLOYED IN THE LAD. HOWEVER, IT WAS NOTED UPON ADVANCEMENT OF A POST DILATATION BALLOON, THE STENT WAS NOTED TO BE ACCORDIONED AND IN THE LEFT MAIN. THE PT WAS SENT TO SURGERY FOR CABG. IT SHOULD BE NOTED THAT THE LAD WAS NOT PREDILATED.
A. 1,4) INFO WAS NOT AVAILABLE. H. 6) METHOD-REVIEW OF FILM.
THE IAB WAS INSERTED INTO THE PATIENT ON 10/3/96. ON 10/4/96 AFTER IABP FOR 31 HOURS, BLOOD BACKED IN THE IABP TUBING AND THE IAB WAS REMOVED. NO SECOND WAS INSERTED. EVENT COMPLICATIONS: UNK REPORTED 10/7/96; NONE - REPORTED 10/31/96. PATIENT'S CURRENT STATUS: RECOVERING FROM SURGERY.
MANUFACTURING INFORMED. CORRECTIVE ACTION WAS TAKEN. THE LOT THAT WAS PROVIDED BY THE DISTRIBUTOR DOES NOT MATCH THE PRODUCT THAT WAS REC'D. CO KNOWS THAT IT WAS MANUFACTURED PRIOR TO THE 7/1996 DATE, DUE TO THE CORDSET ON THE PENCIL. THE CORRECT LOT # IS NOT KNOWN. THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 10/22/96. CO WAS UNABLE TO CONFIRM OR DUPLICATE THE PERFORMANCE PROBLEM. IT WAS NOTED THAT WHEN THE PENCIL WAS DISASSEMBLED, SMALL CUT WIRES WERE FOUND UNDERNEATH THE SILICONE SLEEVE ON THE PRINTED CIRCUIT BOARD. CORRECTIVE ACTION HAS BEEN TAKEN.
PT DEATH -NO ALARM AT CENTRAL MONITORING STATION.
THE FAILURE TO ALARM ON PT ASYSTOLE WAS DETERMINED TO BE THE RESULT OF BEDSIDE ALARMS AND CENTRAL STATION ARRHYTHMIA PROCESSING BEING TURNED OFF BY THE USER. THE CENTRAL STATION WAS DETERMINED BY HOSP BIOMEDICAL ENGINEERING PERSONNEL AND BY ANALYSIS VIA TELEPHONE COMMUNICATIONS BETWEEN CO TECHNICAL SERVICES PERSONNEL AND NURSING AND BIOMEDICAL ENGINNERING PERSONNEL AT THE HOSP. TO BE FUNCTIONAL AND PERFORMING WITHIN SPECIFICATIONS WITH RESPECT TO ALARMS REPORTING. PRODUCT LABELING (OPERATOR'S MANUAL) CLEARLY STATES THAT ARRHYTHMIA PROCESSING IS DISCONTINUED WHEN TURNED "OFF" AND THE USER MUST RESPOND "YES" TO AN "ARE YOU SURE" PROMPT BEFORE ARRHYTHMIA PROCESSING IS DISCONTINUED. ADDITIONALLY, BOTH THE OPERATOR'S MANUAL AND THE CENTRAL STATION DISPLAY ADVISE THE USER TO CHECK THE BEDSIDE ALARM STATUS TO CONFIRM APPROPRIATE PT ALARMS ARE ENABLED WHEN ARRHYTHMNIA PROCESSING IS TURNED OFF. ARRANGEMENTS ARE BEING MADE FOR A CO CLINICAL APPLICATIONS SPECILIST TO CONDUCT ADD'L INSERVICE TRAINING ON THE CO MONITORING SYSTEM AT THE FACILITY.
DEVICE LABEL CODES: 1738, 1077. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 10/7/96. PATIENT'S CURRENT STATUS: EXPIRED 10/4 - RPT'D 10/7.
DURING A BREAST AUGMENTATION PROCEDURE, THIS PAIR OF SCISSORS BROKE AT THE SEAM WHERE THE SCREW GOES IN. ANOTHER PAIR OF SCISSORS WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MDR CONTACT. THIS PAIR OF SCISSORS APPEARS TO HAVE BEEN USED A LOT. THE BLADES HAVE NICKS. THIS SCISSORS IS INTENDED TO BE USED FOR OPHTHALMIC PROCEDUES. IT WAS NOT INTENDED TO BE USED FOR A BREAST AUGMENTATION PROCEDURE.
DURING AN MRI PROCEDURE, AN ANESTHETIZED PT WAS BEING MONITORED WITH AN ECG MONITOR. AFTER APPROX. 35 MINUTES OF SCANNING, THE PT MOVED AND UPON EXAMINATION, THE SKIN APPEARED REDDENED AROUND THE ECG ELECTRODES. NO CHANGES WERE AT THIS TIME. AFTER ANOTHER 25 MINUTES OF SCANNING, THE PT WAS MOVING AGAIN, AND UPON THE SECOND EXAMINATION, THE SKIN AROUND THE ELECTRODES APPEARED VERY RED, AND THE ELECTRODES WERE REMOVED AND THE SCAN WAS COMPLETED. EXAMINATION OF THE PT'S SKIN IN THE RECOVERY AREA REVEALED 4 SKIN BLISTERS. THE NEXT DAY THE PT WAS RETURNED TO THE HOSPITAL AND THE 4 BLISTERS WERE DESCRIBED AS 2 SECOND DEGREE, AND 2 THIRD DEGREE BURNS.
AT THE CONCLUSION OF THE TESTING, FURTHER OPERATOR IN-SERVICING WAS PERFORMED IN REGARD TO THE ECG ELECTRODE SELECTION AND SKIN/ELECTRODE PREPARATION. A PT USE WAS OBSERVED USING THE APPROPRIATE TECHNIQUES, AND NO FURTHER ELECTRODE HEATING WAS OBSERVED. THE OPERATORS HAVE SINCE BEEN FOLLOWING THE MFR'S RECOMMENDED PRACTICES AND NO FURTHER INSTANCES OF ELECTRODE HEATING MAY HAVE BEEN REPORTED. THE MOST PROBABLE CAUSE OF THIS EVENT WAS POSSIBLE USE OF ECG ELECTRODES WITH SMALLER SKIN/ELECTRODE CONTRAST SURFACE AREA, OR ELECTRODES WHICH DID NOT INCLUDE A "WET" GEL ELECTROLYTE. A SUFFICIENT INCREASE IN CURRENT DENSITY AT THE SKIN CAN LEAD TO SKIN HEATING AND SUBSEQUENT SKIN BURNS. IF ANY PORTION OF THE PT'S BODY WAS IN CONTACT WITH THE MRI MAGNET BORE WALL DURING ANY OF THE SCANS, THIS BODY PART (E.G.ARM, LEG, ELBOW,ETC.) COULD PARTIALLY FORM A LOOP WHICH COULD INDUCE RF CURRENT TO FLOW AND POSSIBLY COUPLE WITH THE CURRENT FLOWING IN THE PT ECG CABLE. ALTHOUGH IT COULD NOT BE DETERMINED IF THIS CONDITION OCCURRED, FOR ANY PT UNDERGOING AN MRI SCAN, PARTICULARLY ONE WHO IS ANESTHETIZED AND CANNOT ACKNOWLEDGE OR PREVENT ACCIDENTAL CONTACT WITH THE MRI BORE AFTER BEING INSERTED INTO THE MRI BORE, IT IS CONSIDERED POSSIBLE THAT A BODY PART COULD HAVE CONTACTED THE MRI BORE, AND MAY HAVE CONTRIBUTED TO THE ELECTRODE HEATING. CONTACT OF THE PT'S SKIN OR BODY PARTS IS CONTRAINDICATED IN THE MRI MFR'S PRODUCT LABELING. ANY LOOP INVOLVING THE PT ECG CABLE, SUCH AS WITH A PORTION OF THE BODY, CAN INDUCE MORE RADIOFREQUENCY (RF) CURRENT TO FLOW IN THE CABLE DURING A SCAN, AND ALLOW ELECTRODE HEATING TO OCCUR.
AN AORTIC DEVICE WAS EXPLANTED AND REPLACED DUE TO A SUSPECTED LEAFLET IMMOBILITY. PROPER VALVE FUNCTION WAS NOT VERIFIED AT THE TIME OF IMPLANT. IT WAS REPLACED WITH ANOTHER DEVICE.
SECTION H6: METHOD CODES: (86) OTHER - A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED. RESULT CODES: (100) OTHER - DEVICE HISTORY RECORDS REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS FOR A SIZE AORTIC CPHV AT THE TIME OF MFR AND RELEASE.
SEEN ON 9/27/96 IN CLINIC FOR LABWORK AND DESFERAL INFUSION. PT COMPLAINED SITE PAIN PRIOR TO MED INFUSION. DIFFICULTY DRAWING BLOOD VIA PORT. UROKINASE FLUSH ATTEMPTED; PAINFUL. RADIOLOGICAL STUDY COMPLETED. USER FACILITY BELIEVES SILASTIC FAILED AT POINT OF INSERTION INTO THE OUTER CANNULA THAT ATTACHES TO THE PORT. RETRIEVAL OF CATHETER ATTEMPTED BY SURGEON AND CARDIOLOGIST; UNSUCCESSFUL.
CASSETTE WOULD NOT FIT IN MICROSURGICAL SYSTEM. DEFECT WAS DISCOVERED DURING SETUP FOR SURGERY.
EVAL SUMMARY FROM H.3. CASSETTE WAS TESTED IN A MICROSURGICAL SYSTEM AND DEFECT COULD NOT BE CONFIRMED.
DURING A CATARACT EXTRACTION PROCEDURE, THE VITRECTOMY MODE OF THIS OPHTHALMIC MICROSURGICAL UNIT FAILED. THERE WAS NO PULSE OR ASPIRATION. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE.
PT CAME IN FOR HEMODIALYSIS TREATMENT. UPON HOOK-UP TO BLOOD LINE SHE COMPLAINED OF IMMEDIATE PAIN SENSATION IN HER ACCESS ARM AND SHE PROCEEDED INTO FULL CARDIAC ARREST. CPR WAS INITIATED AND PT WAS RESUSCITATED AND TRANSPORTED VIA AMBULANCE TO HOSP.
THE METHOD OF EVAL INCLUDED INTERVIEWING REPORTER FROM USER FACILITY AND REVIEW OF PRODUCTION RECORDS. THE PRODUCTION RECORDS INDICATE THE PRODUCT MET ALL SPECIFICATIONS UPON RELEASE. THE REPORTER STATED IN A PHONE CALL ON 10/4/96 THEY BELIEVE A DEVIATION FROM FACILITY SOP'S CAUSED THE EVENT. THE CORRECT EXPIRATION DATE FOR THE PRODUCT IS 7/97, 10/7/96 AS REPORTED BY THE USER FACILITY IN D5.
THE DEVICE RESERVOIR WAS RECEIVED. THE CATHETER WAS NOT INCLUDED, THEREFORE, A LETTER HAS BEEN SENT TO THE IMPLANTING DR REQUESTING POST-IMPLANT AND PRE-EXPLANT X-RAYS. THE ANALYSIS CAN ONLY PROCEED WITH THE X-RAYS REQUENSTED.
SCREWS WOULD NOT FRICTION LOCK INTO CENTER SLOT OF A PLATE. SCREWS WERE ORIGINALLY IMPLANTED 8/96. BOTH WERE PLACED INTO VERTEBRAL BODIES TO ADD STABILITY TO A THREE LEVEL DISC FUSION. THEY WERE BOTH BACKING OUT AS SEEN ON PLAIN LATERAL POST-OP FILMS, ONE FAR ENOUGH TO CAUSE ESOPHAGEAL IRRITATION AND DYSPHAGIA. THE TWO SCREWS WERE REMOVED.
SCREWS WERE WORN TO THE POINT THAT DIMENSIONAL EVALUATION WAS INCONCLUSIVE. PER TOLERANCES ON PRINT SCREWS SHOULD LOCK INTO PLACE. SINCE INSPECTION PROCEDURES ARE IN PLACE TO MAKE SURE PRODUCTS MEET SPECIFICATIONS WHEN THEY ARE SHIPPED THE WEAR PROBABLY WAS A RESULT OF THE MANNER IN WHICH THE SCREWS WERE REMOVED. DESIGN HAS SINCE BEEN MODIFIED TO INCREASE INTERFERENCE.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE WOULD NOT PHACO. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. ALTHOUGH THE HANDPIECE FAILED CONCENTRICITY, THE REPORTED PROBLEM COULD NOT BE DUPLICATED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT REPORTED THE CLIP SCISSORED AND TRANSECTED THE CYSTIC VESSEL. A SECOND CLIP APPLIER WAS USED TO FINISH THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B3,6,7,D10-INFORMATION NOT PROVIDED BY USER FACILITYH4,D5,6-INFORMATION NOT AVAILABLEH6:CODE 400(OTHER): YIELDED JAWS
TOTAL KNEE REVISION (OF LEFT KNEE) DUE TO POSTOPERATIVE INFECTION.
DEVICE WAS USED AT HOME TO RELIEVE PAIN AND MANAGE LONGTERM PAIN. IT WAS ALSO USED AS TREATMENT IN THE MGMT OF POST SURGICAL ACUTE PAIN. DEVICE WAS APPLIED TO PT'S BACK MUSCLE. THE WIRES IN THE DEVICE WERE FAULTY DUE TO A BAD CONNECTION AND THE DEVICE GAVE OFF MORE SHOCKS THAN EXPECTED WHICH RESULTED IN PT'S EXPERIENCING PAIN, ACUTE DISCOMFORT AND RASH. DEVICE CAME WITH A HANDBOOK THAT STATED IT WAS NOT TO BE USED ON PTS WITH HEART DISEASE. PT STATES HE DOES NOT HAVE HEART DISEASE. PT NEVER REPORTED INCIDENT TO HIS MD, BUT HE SENT THE DEVICE FOR THE SIXTH TIME TO THE MFR.
PT HAD UNDERGONE SHUNT REVISION THREE WEEKS PRIOR TO INSERTION OF NEW VP SHUNT ON 8/13/96. AT INSERTION THE ICP WAS NOTED TO BE HIGH. CONSIDERABLE FLOW WAS OBSERVED. APPROX. EIGHT HRS LATER A RESPIRATORY ARREST OCCURRED. THE CT SCAN SHOWED DIFFUSE CEREBRAL EDEMA WITH COLLAPSED VENTRICLES. THE PT DIED TWO DAYS LATER DESPITE HYPERVENTILATION AND STEROIDS.
ADDITIONAL PT CODES: 2078, 2200 - HIGH INTRACRANIAL PRESSURE DOES NOT SPEIFICALLY MENTION CEREBRAL EDEMA OR RESPIRATORY ARREST, BUT DOES SPECIFY "VARIABLE ABNORMAL NEUROLOGICAL FINDINGS". H6 CODE 300 - SEE BELOW, DEVICE EVALUATION. PRODUCT WAS VISUALLY EXAMINED AND TESTED FOR PATENCY, PRESSURE/FLOW CHARACTERISTICS AND PREIMPLANTATION PRESSURE. FLOW HOLES OF VENTRICULAR CATHETER FILLED WITH DRIED BLOOD-LIKE SUBSTANCE. VALVE HAS DRIED BLOOD-LIKE SUBSTANCE IN THE INLET OCCLUDER AREA, DOME AREA AND MEMBRANE CASING AREAS; ALSO INTERMITTENTLY THROUGHOUT THE LENGTH OF THE PERITONEAL CATHETER. NO APPARENT EXTERNAL DAMAGE TO THE VALVE. PRODUCT COULD NOT BE PROPERLY TESTED DUE TO THE EXCESS AMOUNT OF BLOOD-LIKE MATTER IN THE VALVE. WHEN ATTEMPTING TO PERFORM THE PATENCY AND PRESSURE/FLOW TESTS, SOME OF THE DRIED BLOOD SOLUBILIZED AND FLOWED INTO THE MEMBRANE CASING/SEAT AREAS, IMPEDING FUNCTIONING OF VALVE.
APPROX 6-8 HRS AFTER IMMOBILIZER WAS APPLIED, PT ALLEGEDLY HAD THE EXTENSION AND ANKLE DORSIFLEXION.
VALVE WAS IMPLANTED ON 10/23/95 AND REVISED ON 6/26/96 DUE TO DISTAL CATHETER FRACTURE.
ALTHOUGH CO HAS ATTEMPTED TO OBTAIN THE QUESTIONED PRODUCT FOR ANALYSIS, IT IS CURRENTLY NOT BEING RELEASED BY THE HOSPITAL DUE TO  POTENTIAL LEGAL ISSUES. IF IT IS POSSIBLE FOR TO OBTAIN THE QUESTIONED PRODUCT AND PROCEED WITH THE PRODUCT EVALUATION.
DURING AN OPHTHALMIC PROCEDURE, THIS PAIR OF SCISSORS BROKE. ANOTHER PAIR OF SCISSORS WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MDR CONTACT. THIS PAIR OF SCISSORS IS VERY OLD. THE SOLDER IS WORN OFF ON THE SPRING AND PITTING AND CORROSION IS PRESENT. CAUSE FOR CORROSION IS MOST PROBABLE DUE TO IMPROPER CLEANING TECHNIQUES OR THE USE OF HARSH CLEANING SOLUTIONS.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE WOULD NOT PHACO. THE HANDPIECE WAS DISCONNECTED AND RECONNECTED AND IT THEN WAS ABLE TO BE USED. THE PROCEDURE WAS DELAYED APPROX 15 MINS.
THIS FORM WAS COMPLETED BY MFR. SECTION F WAS ALSO COMPLETED BY MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE LABEL CODE: 1738. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY UNFOLDED. BLOOD WAS NOTED ONLY ON THE EXTERIOR OF THE IAB. KINKS WERE NOTED IN THE INNER LUMEN. VISUAL EXAMINATION REVEALED THE INNER LUMEN WITHIN THE MEMBRANE TO BE SEVERELY KINKED AND ELONGATED. THE MEMBRANE AT THE PROXIMAL TAPER WAS OBSERVED TO BE STRETCHED. WHEN THIS AREA WAS VIEWED UNDER POLARIZED LIGHT, THE AREA APPEARED STRESSED. UNDERWATER LEAK TESTING FOUND NO LEAKS IN THE ENTIRE DEVICE. IT WAS NOT POSSIBLE TO SATISFACTORILY PUMP THE IAB ON THE SYSTEM 90 IABP IN THE LABORATORY DUE TO THE CONDITION OF THE MEMBRANE TAPER. PROBABLE CAUSE OF DIFFICULTY: NO LEAK WAS FOUND IN THE DEVICE (WHICH IS NORMALLY ASSOCIATED WITH THIS TYPE OF COMPLAINT). THE PHYSICAL CONDITION OF THE RETURNED IAB DOES SUPPORT THE REPORTED DIFFICULTY. IT IS NOT POSSIBLE TO DETERMINE THE EXACT REASON FOR THE ENCOUNTERED PROBLEM. DIFFICULTY REMOVING THE IAB FROM THE PATIENT MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: A KINK IN THE CATHETER TUBING TRAPPED HELIUM IN THE MEMBRANE PREVENTING IT FROM FULLY COLLAPSING UNDER NORMAL ARTERIAL PRESSURE ALLOWING FOR EASY REMOVAL OF THE BALLOON FROM THE PATIENT. THE PATIENT'S ANATOMY.
REPORTED TO DATASCOPE ON 9/20/96: WHEN THE ATTEMPT WAS MADE TO REMOVE THE IAB IN THE USUAL MANNER, SIGNIFICANT RESISTANCE WAS MET WITH 3/4 OF THE BALLOON REMAINING IN THE PATIENT'S ARTERY. THE SURGEON WAS NOTIFIED. THE SURGEON REMOVED THE IAB WITH A LOT OF DIFFICULTY.
CO HAS DETERMINED THAT 314 (THREE HUNDRED FOURTEEN) PIECES OF LENSES HAVE BEEN MISLABELED. TWO (2) WERE ACTUALLY -3.50 LABELLED AT -5.50 DIOPTERS AND THREE HUNDRED TWELVE (312) WERE ACTUALLY -3.75 LABELLED AT -5.75 DIOPTERS. CO BECAME AWARE OF THIS SITUATION ON 10/21/96 WHEN SIX PIECES WERE RECEIVED AS RETURNS/COMPLAINTS FROM TWO DIFFERENT CUSTOMERS. SINCE BEING NOTIFIED CO HAS ASSEMBLED A DISTRIBUTION REPORT AND HAVE DETERMINED THAT ALL OF THE PRODUCT HAS BEEN DISTRIBUTED. CO IMMEDIATELY BEGAN THE PROCESS OF CALLING ALL OF THE ACCOUNTS WHO PURCHASED THE PRODUCT TO REQUEST A RETURN. AS SOON AS ALL OF THE ACCOUNTS HAVE BEEN CONTACTED CO WILL BEGIN TO RECONCILE THE QUANTITY MFG AND DISTRIBUTED TO THE RETURN QUANTITY. A REPORT WILL BE INITIATED WHICH DETAILS THE INCIDENT, THE ACTIONS TAKEN, THE INVESTIGATION OF CAUSE AND DELINEATION OF CORRECTIVE ACTION.
THE DEVICE FROM THE KIT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE FIRST TWO CLIPS WERE PLACED SUCCESSFULLY. ON THE THIRD FIRING, THE CLIPS STARTED TO FALL OUT OF THE JAWS, UNFORMED, INTO THE ABDOMEN BEFORE THE CLIPS COULD BE PLACED. THE CLIPS WERE REMOVED LAPAROSCOPICALLY. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND WORKED FINE. THERE WAS NO CONSEQUENCE TO THE PT. 9/3/96 REC'D INSTRUMENT FOR ANALYSIS.
BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
WHEN IAB WAS INSERTED INTO THE SHEATH "BLOOD GUSHED OUT." THE CONTACT STATED THAT "IT APPEARED AS IF THERE WAS NO WHITE HEMOSTASIS VALVE" WHICH WOULD HAVE PREVENTED THE BACKFLOW OF BLOOD. THERE WAS MORE BLOOD THAN USUAL.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FROM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER.A 10 FRENCH, 6 INCH SEHATH/HEMOSTASIS VALVE ASSEMBLY WAS RETURNEDF TOR EVALUATION ON THE BALLOON CATHETER. VISUAO EXAMINATION REVEALED THE SHEATH TO BE KINIKED AT THE SHEATH/HUB JUNCTION. THE HEMOSTASIS VALVE GASKET WAS IN PLACE WITHIN THE VALVE. BASED ON THE CONDITION OF THE RETURNED DEVICE, IT WAS NOT POSSIBLE TO SATISTACTORILY TEST THE SHEATH/HEMOSTASIS VALVE ASSEMBLY IN THE LABORATORY. LEAKING IN THE VICINITY OF THE HEMOVALVE MAY HAVE BEEN RELATEDF TO THE KINKING OF THE SHEATH. IT WAS NOT POSSIBLE TO DRAW ANY DEFINITE CONCLUSIONS.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE WOULD NOT FUNCTION. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
THE DEVICE WAS USED DURING A THORACOSCOPY WITH A BLEB RESECTION. THE SURGEON IDENTIFIED THE BLEB AND ASKED THE FIRST ASSISTANT TO FIRE THE DEVICE BECAUSE HE WAS AT A BETTER ANGLE. THE DEVICE WAS FIRED AND THEN BROKE ON THE FIRST FIRING. IT DID NOT STAPLE OR CUT. ANOTHER STAPLER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
INSTRUMENT WAS RETURNED WITH BROKEN FIRING TRIGGER TEETH AND BROKEN SHORT RACK. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
DURING A CATARACT PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE QUIT WORKING. ANOTHER HANDPIECE WAS USED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MDR CONTACT.
THERE WERE TWO SMALL DILATORS IN THE INSERTION KIT AND NO LARGE DILATOR. A NEW USER CARTON WITH A NEW IAB WAS OPENED AND USED.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE LABEL CODE: 1738. THE FOLLOWING LOOSE ITEMS WERE RETURNED TO DATASCOPE: ONE PLASTIC GUIDEWIRE CASING, ONE 10 FR., 11" SHEATH/HEMOSTASIS VALVE ASSEMBLY, ONE LUER LOCK CAP, AND 2 VESSEL DILATORS. THE SERIAL NUMBER OF THE BALLOON ASSOCIATED WITH THESE INSERTION KIT ITEMS WAS NOT REPORTED. NO OTHER PACKAGING MATERIALS OR NUMBERS ASSOCIATED WITH THE DEVICE WERE AVAILABLE. BLOOD WAS NOTED ON THE EXTERIOR OF THE PLASTIC GUIDEWIRE CASING. PROBABLE CAUSE OF DIFFICULTY: EXAMINATION OF THE RETURNED ITEMS DID VERIFY THE PRESENCE OF 2 VESSEL DILATORS. UNFORTUNATELY, IT IS NOT POSSIBLE TO DETERMINE WHEN THE BLUE INTRODUCER DILATOR BECAME MISSING FROM THE INSERTION KIT. IT IS NOT POSSIBLE TO TRACE THE PACKAGING OF THE INSERTION KIT DUE TO A LACK OF INFO. SINCE DATASCOPE TAKES THE POSITION THAT THE CUSTOMER IS CORRECT, A FREE INSERTION KIT HAS BEEN AUTHORIZED FOR THE FACILITY.
DURING A VITRECTOMY PROCEDURE, THE PHYSICIAN WAS EXPERIENCING A BACKFLOW INTO THE PT'S EYE. THE FOOT PEDAL WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH THIS UNIT.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. THERE WAS A FAILURE ON THE RIGHT SIDE OF THE FOOT PEDAL. IT IS POSSIBLE THAT THIS FAILURE COULD HAVE CAUSED THE REPORTED PROBLEM, BUT NOT LIKELY. NO OTHER PROBLEMS WERE FOUND.
THE DEVICE WAS USED DURING A LAPAROSCOPY. IT WAS REPORTED THE DEVICE WOULD NOT STAY ARMED WHEN PUSHED INTO THE INCISION. A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT COULD NOT BE DETERMINED WHY THE INSTRUMENT REPORTEDLY "UNLOCKS TOO EASILY". THE INSTRUMENT WAS RE-ARMED AND CYCLED REPEATEDLY WITHOUT INCIDENT. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS. THE ASSEMBLY LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
PRODUCT WAS USED FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE. DURING THE PRODUCT PROCEDURE, THE WIRE SUPPLIED WITH THE KIT KINKED AND UNRAVELED. THE PRODUCT WAS ABORTED AND HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WAS NO PT INJURY. THE PRODUCT HAS BEEN RETURNED AND WILL BE EVALUATED FOLLOWING STERILIZATION.
CODE 86: EVAL OF EVENT BASED ON MFG AND QC PROCEDURES, AND HISTORICAL USE OF DEVICE RELATED TO THIS EVENT. THIS INFO WAS PROVIDED TO A CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. DEVICE WAS USED UNEVENTFULLY IN RCFA FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE. THE PT WAS DISCHARGED THE FOLLOWING DAY ALTHOUGH A SMALL HEMATOMA WAS PRESENT AND THE PT WAS EXPERIENCING PAIN IN THE LOWER BACK AND RT LEG AND BUTTOCK. FIVE DAYS POST DEVICE AN ELECTIVE ANGIOPLASTY VIA LFA WAS SCHEDULED. AT THAT TIME A PSEUDOANEURYSM WAS DIAGNOSED WHICH WAS SUCCESSFULLY TRETAED WITH ULTRASOUND GUIDED COMPRESSION. CODE 200: PSEUDOANEURYSMS CAN RESULT IF THE COLLAGEN IS NOT PLACED ACCURATELY OVER THE ARTERIAL PUNCTURE SITE. HOWEVER, THIS COMPLICATION IS NOT UNUSUAL FOLLOWING CARDIAC CATHETERIZATION PROCEDURES. THEREFORE, CO CAN NOT ATTRIBUTE THIS EVENT TO THE USE OF DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF CO THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. THE RETURNED GUIDEWIRE HAS BEEN EVALUATED. IT HAD UNRAVELED. THIS COMPONENT OF PRODUCT IS PURCHASED. CO IS COMMUNICATING WITH THE MFR TO OBTAIN FURTHER INFO. ADD'L INFO WILL BE PROVIDED WHEN AVAILABLE. THE MFR OF THE GUIDEWIRE  EXAMINED THE GUIDEWIRE AND FOUND NO MATERIAL DEFECTS OR FLAWS. DURING THE PROCEDURE, THE GUIDEWIRE IS IN THE ARTERY WHILE OCCLUSIVE PRESSURE IS BEING HELD. IT IS POSSIBLE THAT OCCLUSIVE PRESSURE WAS EXCESSIVE CAUSING SUFFICIENT STRESS ON THE GUIDEWIRE TO CAUSE IT TO UNRAVEL. IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE LABELING? N. IF NO, IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? Y. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? Y.
PT UNDERGOING C-SECTION RECEIVED A SADDLE BLOCK AND SUBSEQUENTLY DEVELOPED A GENERALIZED RASH. SEEMED TO WORSEN AFTER RECEIVING MEPERIDINE. RASH RESOLVED WITH DISCONTINUATION OF DRUG.
WORK ORDER WAS REVIEWED. ALL IN-PROCESS AND FINAL PRODUCT TESTING SPECIFICATIONS WERE ACCEPTABLE. FINAL PRODUCT RESULTS ARE AS FOLLOWS: LIDOCAINE 100% PH: 6.7 TOT NA.: 101.1% ENDOTOXIN" LT 0.6 EU/ML STERILITY: PASSES
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP. THE DEVICE MISFIRED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFO NOT PROVIDED BY AFFILIATE. D5,6;H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
DURING NASAL SURGERY, THIS PAIR OF SCISSORS BROKE AT THE HANDLE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MDR CONTACT. HANDLE MAY HAVE CRACKED WHEN THE MFR'S LOGO WAS STAMPED ON THE SCISSORS.
INTERMITTENTLY UNIT STOPS CYICLING AND ALARMS LOW PRESSURE/APNEA AND SETTING ERROR. NO PT HARM.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP, THE INSTRUMENT JAMMED AND BROKE. THERE WAS NO CONSEQUENCE TO THE PT.
DURING A CATARACT EXTRACTION PROCEDURE USING THIS PHACOEMULSIFICATION HANDPIECE, ONE PIECE OF PARTICULATE WAS RETRIEVED FROM THE PT'S EYE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MDR CONTACT. THIS HANDPIECE FAILED TO CALIBRATE WHEN TESTED. A FILTER TEST WAS PERFORMED AND NO PARTICULATE WAS FLUSHED FROM THE HANDPIECE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP. THE NOSE OF THE DEVICE MISFUNCTIONED. THERE WAS NO CONSEQUENCE TO THE PT.
H6: CODE 400: EXCESSIVE BODY FLUID IN CARTRIDGE ASSEMBLY.
THE CLEAR HEMOSTASES VALVE LEAKED MORE THAN USUAL. THE HEMOSTASIS VALVE WAS NOT RETURNED TO CO FOR EVAL. THE HEMOSTASIS VALVE WAS DISCARDED.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THE DEVICE DID NOT CUT. THERE WAS NO CONSEQUENCE TO THE PT.
ALTHOUGH THE INVESTIGATION OF THE EVENT IS NOT YET COMPLETED, THE ABRUPT ONSET OF SYMPTOMS, AND RAPID DETERIORATION OF PT CONDITION BEGAN A DIAGNOSTIC WORK-UP AND TREATMENT FOR AIR EMBOLISM, POSSIBLY DUE TO THE CATHETER. THE PT HAD BEEN MEDICALLY STABLE, PREPARING FOR DISCHARGE WHEN A NURSE ENTERED THE ROOM AND NOTED THE INFUSING TPN HAD DISCONNECTED FROM THE DEVICE. THERE WAS A SMALL SPOT OF BLOOD NOTED AT THE CATHETER END HUB. IMMEDIATE WITH THIS FINDING THE PT'S HEART RATE DROPPED AND SUBSEQUENTLY THE PT ARRESTED, WAS INTUBATED AND THEN STABILIZED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP. THE CLIPS WOULD NOT DELIVER. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D5,10;H4: INFO NOT PROVIDED. H10: ADDITIONAL MFR NARRATIVE EVALUATION CODE RESULTS #100: "THE INSTRUMENT WAS RECEIVED WITH A TWISTED STAPLE JAMMED IN THE CARTRIDGE NOSE, WHICH WERE RMEOVED, AND THE INSTRUMENT THEN FUNCTIONED AS DESIGNED. NO CONCLUSION COULD BE DRAWN AS TO HOW THE STAPLE HAD BECOME TWISTED AND JAMMED IN THE CARTRIDGE NOSE". RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT'S "CLIPS WOULD NOT DELIVER" DURING SURGERY MAY HAVE BEEN DUE TO A TWISTED STAPLE IN THE CARTRIDGE NOSE WHICH CAUSED THE INSTRUMENT TO JAM. THE INSTRUMENT WAS RECEIVED WITH A TWISTED STAPLE IN THE NOSE AND WAS NOTED TO BE VERY CLEAN. THE TWISTED STAPLE WAS REMOVED FROM THE CARTRIDGE NOSE AND THE INSTRUMENT WAS CYCLED AND FIRED THE REMAINING 22 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO HOW THE STAPLE HAD BECOME TWISTED AND JAMMED IN THE CARTRIDGE NOSE.
DURING A FRAGMENTATION PROCEDURE, FLUID BACKED UP INTO THE IOP PORT OF THIS MICROSURGICAL UNIT. THE PROCEDURE WAS ABLE TO BE COMPLETED USING THIS UNIT.
SECTIONS A THROUGH F WERE COMPLETED BYT HE MFR. BALANCED SALT SOLUTION (BSS) CONTAMINATION IN THE IOP CIRCUIT RESULTED IN THE NEED TO REPLACE THE PNEUMATIC DRAWER OF THIS UNIT.
THE SHEATH OF THIS DEVICE BROKE OFF DURING THE PROCEDURE. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE. THE DEVICE IS NOT BEING RETURNED FOR CO'S ANALYSIS.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THERE WAS LEAKAGE FROM THE BALLOON. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4,B3,6,7,D10,E1,2,3-INFO NOT PROVIDED BY AFFILIATE. H4,D5,6-INFO NOT AVAILABLE, DEVICE NOT AVAILABLE FOR EVALUATION. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE BALLOON HAD RUPTURED DURING SURGERY, MAKING THE INSTRUMENT NON FUNCTIONAL. THE INSTRUMENT WAS RECEIVED WITH A BALLOON WHICH HAD RUPTURED. THE POINT OF ORIGIN WAS DETERMINED TO HAVE PROPAGATED 110 DEGREES FROM THE STOPCOCK POSITION IN THE PROXIMAL PORTION OF THE BALLOON, JUST DISTAL OF THE ATTACHMENT RING. IT APPEARED AS THOUGH SOMETHING CAUGHT OR TRAPPED THE BALLOON AGAINST THE EXTENSION. THERE WAS A 1/4 INCH ABRASION MARK AT THE RUPTURE POINT OF ORIGIN. THIS INQUIRY WAS ORIGINALLY REPORTED AS AN RPO (RECORD PURPOSES ONLY). EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY.
EVENT INCLUDED IN LABELING. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER."
DURING A CATARACT EXTRACTION PROCEDURE, THIS PAIR OF FORCEPS SPRUNG OPEN. ANOTHER INSTRUMENT WAS USED FOR THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MDR CONTACT. THIS INSTRUMENT IS NON-MAGNETIC AND THE MATERIAL IS VERY SOFT. IT IS NOT INTENDED TO BE USED ON HEAVY MATERIAL OR IT WILL BEND. IT WAS SUGGESTED THAT THE CUSTOMER USE AN ALTERNATIVE INSTRUMENT WHICH IS HARDENED AND WILL NOT BEND.
PT FOR ROTATIONAL ATHRECTOMY FOR HISTORY OF RECURRENT ANGINA, SEVERE DISEASE OF OSTIAL PDA. AFTER TWO BURRS WERE UTILIZED, POST TEST INJECTION REVEALED THAT THE PT HAD A SIGNIFICANT PERFORATION OF THE PDA. COMPLICATIONS FROM THE PERFORATION WERE CARDIAC TAMPONADE AND CARDIAC ARREST. EMERGENCY SURGERY WAS DONE IN CATH LAB FOR CLOSURE OF THE PERFORATED RT CORONARY ARTERY. AFTER SURGERY, PT SENT TO ICU. PT'S CONDITION FAIRLY STABLE. BP IN THE RANGE OF 80-90. A CATHETER WAS PLACED. AFTER THE PT ARRIVED IN ICU, A LOW HEMOGLOBIN WAS NOTED AND ARRANGEMENTS WERE MADE TO GET BLOOD. BLOOD PRESSURE WAS FALLING AND THE DOSE OF VASOPRESSOR AND FLUID WAS INCREASED. HOWEVER, THE PT GRADUALLY SHOWED FURTHER DETERIORATION. THE PT'S RHYTHM BECAME UNSTABLE WITH EPISODES OF BRADYCARDIA, ASYSTOLE, VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION FOR WHICH THEY WERE CARDIOVERTED BUT DID NOT IMPROVE AND FINALLY EXPIRED.
DURING THE PROCEDURE, THIS DEVICE FAILED TO REMAIN TIGHTENED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BIENG RETURNED FOR ANALYSIS.
PT HAD DISCOMFORT AROUND KNEE AFTER FALLING. REVISION SURGERY REVEALED WEAR AT ANTERIOR MEDIAL AND POSTERIOR PORTION.
EVALUATION RESULTS SUGGEST THAT THIS EVENT IS ASSOCIATED WITH ABNORMAL TRACKING OF THE FEMORAL COMPONENT ON THE INSERT.
FAILED LEFT TOTAL KNEE PATELLA COMPONENT. REQUIRED LEFT TOTAL KNEE REVISION AND TIBIA INSERTION.
SURGICAL CENTER REPORTS WOUND HAD TO BE WIDENED TO REMOVE LENS WITH A BENT HAPTIC. SURGEON CONFIRMS THAT AFTER IOL INSERTION THE TRAILING HAPTIC WAS NOTED TO BE BENT AFTER PLACEMENT IN THE EYE. THE HAPTIC WAS NORMAL PRIOR TO FOLDING AND INSERTION. THE WOUND WAS WIDENED IN ORDER TO REMOVE THE LENS AND A REPLACEMENT LENS OF THE SAME STYLE WAS INSERTED. NO OTHER PATIENT IMPACT WAS REPORTED.
THE LENS EVALUATION CONFIRMED THAT ONE HAPTIC WAS BENT AS REPORTED BY THE CUSTOMER. THIS REPORT WAS MAILED IN TO FDA ON: 2/21/97.
A PT WAS TREATED ON 10/30/96 INTO THE NASOLABIAL FOLDS. ON 10/30/96, SWELLING OF THE LIP WAS NOTED; DECONGESTANT TABLETS WERE PRESCRIBED. THE PHYSICIAN BELIEVED THAT THE SWELLING WAS RELATED TO COLLAGEN.
ON 5/6/97, FOLLOW UP INFO WAS RECEIVED: SYMPTOMS OF THE PATIENT RESOLVED WITHIN ONLY A FEW DAYS COMPLETELY. THE PHYSICIAN BELIEVED THIS WAS DUE TO THE APPLICATION OF ANTIHISTAMINES.
DIALYZER DEVELOPED A BLOOD LEAK ON ITS FIRST USE. TREAMTENT WAS ABOUT HALFWAY THROUGH WHEN THE LEAD WAS NOTICED. EBL 150CC. THERE WAS NO PT INJURY. DIALYZER WAS DISCARDED.
NO INVESTIGATION WAS PERFORMED BECAUSE THE UNIT WAS NOT RETURNED. CO HAS INFORMED THE MFG FACTORY OF THIS OCCURRENCE, AND THE CATALOG NUMBER AND THE LOT NUMBER HAVE BEEN DOCUMENTED. NO ABNORMALITY OF THE QUESTIONED CATALOG NUMBER/LOT NUMBER. CO CAN ONLY PRESUME THAT SOME FACTOR OF PREPROCESSING  MAY HAVE INFLUENCED THE STRENGTH OF THE FIBER.
WHILE PT WAS AT SCHOOL PRESSURE LIMIT VALVE WAS STICKING AND VENTILATOR WAS HIGH AND LOW PRESSURING. THEREFORE, NOT DELIVERING PRESCRIBED VT.
USER PICKED UP CUP OF STERILANT CONCENTRATE AND FLICKED BOTTOM OF CUP, AT WHICH TIME LIQUID SPRAYED OUT FROM SIDE OF OUTER CUP SEAL. USER WAS SPLASHED ON NECK, CHEST, AND ARM. SECOND DEGREE BURNS RESULTED.
COMPLAINANT ALLEGED THAT DURING HANDLING OF STERILANT CONTAINER, USER BURNED WHEN LIQUID SPRAYED FROM THE SIDE OF THE OUTER CUP SEAL. LOT NUMBER WAS UNAVAILABLE. INVESTIGTION REVEALED THAT CONTAINER HAD BEEN SITTING ON A TABLE IN DIRECT SUNLIGHT FOR APPROX 4 DAYS, AT A TEMPERATURE ESTIMATED BY THE COMPLAINANT TO BE 90 DEGREE F. CO TESTING HAS BEEN UNABLE TO DUPLICATE A SEAL FAILURE WHICH COULD CAUSE A RELEASE OF THE LIQUID CONTENTS, EVEN UNDER EXTREME TEMPERATURE CONDITIONS. AT THIS TIME, CO IS NOT CERTAIN HOW THE ALLEGED SITUATION COULD OCCUR, BUT WILL REVIEW FUTURE COMPLAINTS OR SIMILARITIES. AS THIS IS VIEWED AS AN ISOLATED INCIDENT, NO CORRECTIVE ACTION IS BEING TAKEN AT THIS TIME.
THE MD HAD DIFFICULTY TRYING TO INSERT THE CATHETER THROUGH THE SHEATH SO HE CUT THE STAT-GUARD. THE IAB AND SHEATH WERE USED AND WERE NOT RETURNED TO CO FOR EVALUATION.
HOSPITAL REPORTS CAPSULE TORE WHILE LENS WAS UNFOLDING.
THE EVALUATED LENS WAS NOTED TO HAVE ONE BROKEN HAPTIC. HOWEVER, HAPTIC DAMAGE MAY HAVE BEEN CAUSED DURING REMOVAL OF THE LENS FROM THE EYE DUE TO THE TORN CAPSULAR BAG. THE MFR'S INTERNAL REF. #96L5727.
A1,2,3,4;B3,6,7;D10:INFORMATION NOT PROVIDED BY AFFILIATE. D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. BONE LOSS WAS NOTED. THE PT HAS EMPHYSEMA.
86=DIMENSIONAL ANALYSIS, 100=THE RETURNED COMPONENT MET INTERPORE VISUAL AND DIMENSIONAL ANALYSIS IN ALL RESPECTS.
INFANT VENTILATOR FAILED TO CYCLE, NO PRESSURE DELIVERED TO INFANT. MACHINE FAILED X2. RESPIRATORY THERAPIST AND RN PRESENT. NO ADVERSE EFFECTS TO THE PT DUE TO THIS MALFUNCTION. THIS UNIT ALSO FAILED DURING TRAINING ON A TEST LUNG AFTER THE PREVIOUSLY MENTIONED INCIDENT.
THE SUBJECT DEVICE WAS SET TO DELIVER HEPARIN AT 20 ML/HR. ONE HOUR TO AN HOUR AND A HALF LATER, THE RATE HAD SPONTANEOUSLY CHANGED TO 77 ML/HR. THE DEVICE'S OPERATION LOG SHOWED THE RATE TO BE SET AT 20 ML/HR, THEN 160 ML/HR, THEN BACK TO 20 ML/HR. THE PT WAS MONITORED AND THE HEPARIN WAS RESTARTED 12 HOURS LATER.
THE SUBJECT DEVICE WAS TESTED BY THE MFR AND WAS FOUND TO DELIVER WITHIN SPECIFICATION. A. PATIENT INFORMATION IS NOT ABLE TO BE PROVIDED BY THE HOSPITAL.
THE REPORTER STATED THE DEVICE WAS REVISED DUE TO PAIN.
THE INFORMATION PROVIDED AND THE EXAMINATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH PATIENT PAIN.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THE DEVICE MISFIRED. THERE WAS NO CONSEQUENCE TO THE PT.
HOMECARE PT WAS BEING FED USING A PUMP. 200-250 ML OF AN ENTERAL FEEDING SOLUTION WITH FIBER WERE HUNG, AND THE PUMP WAS SET TO DELIVER 185 ML/HR. 200-250 ML WERE DELIVERED IN 1 HR. ONE PT INVOLVED.
SECOND TEST ISQ SET LOT #091662401 STOCK CODE #71 STOP WATCH K-92, SUN TIME: 60 MINUTES. PRODUCT USED: REPLATE. SET DATE: 185 ML/HR. AMOUNT DELIVERED: 188 ML. CALCULATED DELIVERY: 185 ML. VOLUME FED READING: 185 ML. PUMP DELIVERED WITHIN SPECIFICATIONS DURING BOTH TEST. COMPLAINT OF 31 UPS NOT CONFIRMED.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH A PORTION OF THE MEMBRANE NOTED TO BE LOOSELY FOLDED. A 3-WAY STOP COCK WAS NOTED TO BE ATTACHED TO THE EXTRACORPOREAL TUBING. NO KINKS WERE NOTED IN THE DEVICE. A PORTION OF THE 10 FRENCH, 1 INCH SHEATH WAS NOTED TO BE COVERING A PORTION OF THE FOLDED MEMBRANE. LABORATORY EXAMINATION REVEALED NO DEFECTS IN THE  RETURNED IAB. AFTER THE SHEATH WAS PULLED BACK OFF THE MEMBRANE AND THE IAB WAS MANUALLY INFLATED WITH A SYRINGE, IT FUNCTIONED NORMALLY WHEN ATTACHED TO THE SYSTEM 90 IABP IN THE LAB AT 80 AND 160 BPM. NO PUMP ALARMS WERE TRIGGERED. DEVICE LABEL CODE: 1738.
THE FOLLOWING WAS REPORTED TO DATASCOPE ON 9/18/96: THE BALLOON WOULD NOT INFLATE EVEN AFTER MANUAL INFLATION. THE PUMP ALARMED. THE IAB WAS REMOVED AND REPLACED. THIS LAB WORKED PROPERLY.
VENTILATOR FAILED TO CYCLE NO PRESSURE DELIVERED TO INFANT. MACHINE FAILED X2. THE RESPIRATORY THERAPIST AND RN AT THE BEDSIDE. NO ADVERSE EFFECTS TO THE PT DUE TO THIS MALFUNCTION.
THE FIELD SVC REP STATED THAT HE INSPECTED THE VENTILATOR AND COULD NOT REPRODUCE THE EVENT AS DESCRIBED IN THE HOSP REPORT. AS A PRECAUTION HE REPLACED THE EXHALATION VALVE ASSEMBLY.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THE CLIPS WOULD NOT HOLD. THERE WAS NO CONSEQUENCE TO THE PT.
CUSTOMER EXPERIENCED LEAKAGE WITH NO KNOWN PUNCTURES. CO'S EVAL CONFIRMED LEAKAGE AT THE FREE-FLOW PROTECTOR CLIP. NO PT INJURY OR ADD'L INFO AVAILABLE.
SECTION 10A AND B. AS A RESULT OF REGULATION CHANGES EFFECTIVE 7/31/96, THIS SECTION NO LONGER APPLIES. A,B,6 AND 7,E4,H4. AND 8 UNK ATTEMPTED TO GET MORE DETAILS 10/10/96. H3. LABORATORY EVAL CONFIRMED THE SET TO LEAK FROM A SLICE CUT TO THE TUBING LOCATED AT THE FREE FLOW CLIP. CO'S RESULTS HAVE FOUND THIS TO MOST PROBABLY A RESULT OF MULTIPLE REMOVALS OF THE CASSETTE FROM THE PUMP.
REVISION SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND BREAKAGE OF THE BASEPLATE.
EVALUATION RESULTS INDICATE THE EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH MALALIGNMENT AND INSUFFICIENT CORTICAL SUPPORT.
HOMECARE PT WAS BEING FED WITH AN ENTERAL PUMP. 500 ML OF AN ENTERAL FEEDING SOLUTION WITH FIBER WERE HUNG, AND THE PUMP WAS SET TO DELIVER 100 ML/HR. 500 ML WERE DELIVERED OVER 3.75 HRS. FOLLOWING THE EVENT, THE PT STARTED GAGGING AND REQUIRED PROLONGED SUCTIONING. THE PT CONTRACTED PNEUMONIA AND WAS HOSPITALIZED. ONE PT INVOLVED.
PUMP WAS TESTED TWICE FOR DELIVERY ACCURACY AND IT DELIVERED WITHIN SPECIFICATION TWICE.
DURING A CATHETER EVAL, THE PHYSICIAN OBSERVED A KINK NEAR THE TIP. WHEN THE PHYSICIAN ATTEMPTED TO STRAIGHTEN THE KINK WITH A GUIDEWIRE, THE CATHETER REPORTEDLY "FRACTURED" BY THE SIDEHOLE.
VISUAL EXAM OF THE CATHETER REVEALED THAT ALTHOUGH THE SIDEHOLE WAS DISTORTED DUE TO MANIPULATION BY THE GUIDEWIRE, THERE WAS NO FRACTURE IN THE CATHETER BODY. MEAUSREMENTS OF THE SIDEHOLE AND ENDHOLE DIAMETERS AND THE DISTANCE OF THE SIDEHOLE FROM THE CATHETER TIP WERE WITHIN SPEC. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MDR. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AND ADMISSION ON BEHALF OF CO THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
REVISION SURGERY REVEALED A LATERALLY SUBLUXED HIP WITH POLYETHYLENE WEAR OF THE CUP.
SUMMARY OF EVALUATION: THE INFO PROVIDED AND THE EVALUATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER ASSOCIATED WITH SUBLUXATION DUE TO ACETABULAR COMPONENT POSITIONING.
THE IAB WAS INSERTED INTO THE PT ON 8/28/96 AT 8:00 P.M. ON 8/29/96 AT 6:00 A.M., THE " GAS LOSS" ALARM SOUNDED FROM THE PUMP. THEN, BLOOD WAS NOTED IN THE CATHETER TUBING AND THE IAB WAS REMOVED. NO SECOND DEVICE WAS INSERTED INTO THE PT.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE INNER LUMEN. UNDER MICROSCOPY, THE ROUGH EDGED POINTS OF SEPARATION WERE IRREGULAR IN CONTOUR SUGGESTING THE INNER LUMEN BROKE. THE BROKEN PORTION OF THE INNER LUMEN HAD A WHITISH APPEARANCE, INDICATING A POINT OF STRESS. IT IS POSSIBLE THE IAB WAS RESTRAINED WITHIN THE AORTA DURING IABP. THIS WOULD HAVE RESULTED IN A CYCLICAL STRESS TO THE INNER LUMEN AND, ULTIMATELY, A BREAK. THE IAB MAY HAVE BEEN RESTRAINED AS A RESULT OF PLACEMENT WITHIN A SUBINTIMAL SPACE OR UNDERNEATH PLAQUE. IT IS ALSO POSSIBLE THAT THE INITIAL KINK IN THE INNER LUMEN WAS MADE DURING IAB INSERTION AND THAT IABP CONTINUED TO CYCLICALLY STRESS THE INNER LUMEN AT THAT POINT. DEVICE LABEL CODE: 1738.
IT WAS REPORTED WHILE THE GUIDING CATHETER WAS BEING ADVANCED INTO THE ARTERY THE GUIDE CATHETER KINKED. ACCORDING TO THE PHYSICIAN, A DISSECTION OCCURED IN THE MID AORTA AND THE ILIAC ARTERY WHICH MAY OR MAY NOT HAVE RELATED TO THE KINKED GUIDING CATHETER. PT WAS REPORTEDLY IN STABLE CONDITION, THE DISSECTION WAS TACKED UP WITH STENTS.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSPITAL OR DISTRIBUTOR. ANALYSIS OF THE GUIDING CATHETER REVEALS BEND AND TORSIONAL KINKS. TYPICAL ROOT CAUSES FOR THIS FAILURE MODE ARE DUE TO ONE OR A COMBINATION OF FACTORS. THOSE FACTORS RELATE TO A USER TECHNIQUE, THE DEVICE AND TORTUOUS PT ANATOMY. AFTER REVIEWING THE MANUFACTURING RECORDS AND THE COMPLAINT HISTORY DATA QUALITY ENGINEER HAS COME TO THE CONCLUSION THAT THE DEVICE MET CO PRODUCT SPECIFICATION. NO OTHER COMPLAINTS HAVE BEEN LOGGED AGAINST THIS PARTICULAR LOT NUMBER/PART NUMBER YEAR TO DATE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR THE DEVICE FOR THIS TYPE OF PRODUCT ISSUE. QUALITY ASSURANCE CONSIDERS THIS MDR CLOSED.
THE POLYETHYLENE BEARING INSERT COMPONENT OF THE ACETABULUM PROSTHESIS FAILED NECESSITATING ITS REMOVAL. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. H.4-THE EXACT SIZE IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED. THE MFG LOT NUMBER WAS NOT PROVIDED. D.4-THE MFG DATE IS UNKNOWN BECAUSE THE MFG LOT NUMBER WAS NOT PROVIDED.
A BALLOON DEVELOPED A LEAK ON THE SECOND INFLATION ABOVE ITS RATED BURST PRESSURE DURING DILATATION OF A PREVIOUSLY DEPLOYED STENT. DURING WITHDRAWAL OF THE BALLOON CATHETER, THE BALLOON MATERIAL PULLED BACK FROM THE CATHETER SHAFT. THE BALLOON WAS REMOVED INTACT WITHOUT INCIDENT. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESURIZATION OR USE IN A CALCIFIED LESSION. IT WAS INDICATED THIS DEVICE WAS INFLATED BEYOND ITS RATED BURST PRESSURE AS WELL AS USED TO DILATE A PREVIOUSLY DEPLOYED STENT. CO BELIEVES THESE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "THE RATED BURST PRESSURE SHOULD NOT BE EXCEEDED. INFLATION IN EXCESS OF RATED BURST PRESSURE MAY CAUSE THE BALLOON TO RUPTURE. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY.
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER  SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
CUSTOMER REPORTED EXPERIENCING LEAKAGE AT THE CSSETTE DURING USAGE. NO PT INJURY WAS REPORTED. NO FURTHER INFO IS AVAILABLE.
SECTION 10 A AND B AS A RESULT OF REGULATION CHANGES EFFECTIVE 7/31/96, THIS SECTION NO LONGER APPLIES. A,B,6, B7, H4, AND H.8 UNK. ATTEMPTED TO GET MORE DETAILS 10/8. H3. LABORATORY EVAL CONFIRMED THE SET TO LEAK FROM A SPLIT IN THE CASSETTE FILM AT THE INLET VALVE. THE LEAKAGE OCCURS AFTER CONTINUOUS USE IN THE PUMP; HOWEVER, THE PORBLEM IS NOT WITH THE PUMP, BUT WITH THE SET. THE CASSETTE'S SILICONE RUBBER INLET TUBING HAS BEEN OBSERVED TO MOVE WHILE IN USE. THIS HAS BEEN FOUND TO OCCUR ONLY ON THE CASSETTE AUTOMATED ASSEMBLY PROCESS. IMMEDIATE ACTION HAS BEEN TAKEN TO RESTRICT THE MFG PROCESS TO THE MANUAL PROCESS ONLY. IN ADDITION, IMPROVEMENTS TO THE MATERIAL AND AUTOMATED PROCESS HAVE BEEN DEVELOPED. A PRODUCT ADVISORY IS BEING FORWARDED TO CUSTOMERS 10/96.
DURING A HYSTEROSCOPIC RESECTION PROCEDURE, A LOOP WAS ALLEGEDLY USED. THE WIRE ON THE LOOP BROKE OFF AND WAS LOST INSIDE THE PT'S ABDOMEN. THE DR CONSIDERED IT TO BE THE SIZE OF THE CLIP AND DECIDED NOT TO SEARCH FURTHER. POST-OP FOUND THE PT DOING WELL.
THIS IS A SINGLE USE DISPOSABLE PRODUCT. AFTER THE HOSP TOOK A POLAROID PICTURE OF THE LOOP, THEY DISCARDED IT. HOSP COULD NOT TRACK DOWN ANY PART#, LOT#, OR MFG CODE OF THIS SUBJECT LOOP.
AN ACETABULAR CUP WAS REVISED FOR UNK REASONS.
SUMMARY OF EVALUATION. THE DEVICE IN THIS EVENT WAS RETURNED TO HOWMEDICA R&D BIOLOGICAL AFFAIRS DEPT FOR A HISTOLOGICAL EXAMINATION AT THE REQUEST OF DR OF EPWORTH MEDICAL CENTRE, VICTORIA, AUSTRALIA. THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE.
THE PT, A TYPE II DIABETIC ON ORAL MEDICATION, REPORTED LOWER BLOOD GLUCOSE READINGS WITH THE TEST STRIP. ON 10/7/96, THE PT WENT TO A LAB TO CHECK HER METER AND TEST STRIPS FOR ACCURACY. SHE PERFORMED A SIDE BY SIDE BLOOD GLUCOSE COMPARISON WITH THE TEST STRIP, AND HER METER VERSUS THE LAB WHOLE BLOOD GLUCOSE METER AND TEST STRIPS (TYPE UNKNOWN). THE LAB OFFERS THIS SERVICE ONCE MONTHLY. THE PT DID NOT HAVE A VENOUS BLOOD GLUCOSE LEVEL TAKEN AT THIS TIME. AT THE LAB, THE PT OBTAINED A BLOOD GLUCOSE TEST RESULT OF 159 MG/DL WITH TEST STRIPS AND HER METER AND A RESULT OF 334 MG/DL WITH THE LAB METER AND TEST STRIPS. THE PT IMMEDIATELY DISCONTINUED USE OF THE TEST STRIP AND PURCHASED ANOTHER TEST STRIPS (LOT 609664A, CODE 10, EXP 7/98). WITH THE REP, THE PT PERFORMED A SIDE BY SIDE BLOOD GLUCOSE COMPARISON WITH THE TEST STRIPS AND THE SECOND TEST STRIPS (LOT 609664A, CODE 10, EXP 7/98). SHE OBTAINED RESULTS OF 151 AND 214 MG/DL RESPECTIVELY. THE PT THEN INFORMED THE REP THAT SHE HAD REMOVED THE DESICCANT FROM THE FIRST TEST STRIPS BOTTLE ON 10/7/96 AFTER SHE PERFORMED THE COMPARISON AT THE LAB. FOR THIS REASON, THE REP REQUESTED THAT THE PT OPEN THE SECOND BOTTLE OF TEST STRIPS FROM THE SAME BOX (IN WHICH DESICCANT WAS PRESENT) AND PERFORM A BLOOD GLUCOSE TEST. THE PT OBTAINED A RESULT OF 211 MG/DL. THE SECOND  TEST STRIPS WERE OPENED 10/10/96. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE PT'S NORMAL CONTROL SOLUTION WAS EXPIRED. WITH THE REP, THE PT OBTAINED A CHECK STRIP TEST RESULT OF 85 VERSUS A CHECK STRIP RANGE OF 70-96. THE PT STORES HER TEST STRIPS IN HER LIVING ROOM. BECAUSE THE PT REMOVED THE DESICCANT FROM THE FIRST BOTTLE OF TEST STRIPS AND BECAUSE THE READINGS WITH THE SECOND BOTTLE WERE AN ACCEPTABLE DIFFERENCE FROM THE RESULT OBTAINED WITH THE SECOND TEST STRIPS, THE REP DID NOT REQUEST THE PT'S TEST STRIPS FOR EVAL.
CUSTOMER DID NOT RUN COMPARISONS WIH ACCEPTABLE REFERENCE METHODS. PRODUCT SHOULD NOT BE COMPARED TO OTHER TEST STRIPS WHICH THEMSELVES MAY BE INACCURATE. CUSTOMER DID NOT PERFORM NORMAL CONTROL SOLUTION TEST TO CHECK THE STRIPS FOR ACCURACY. BECAUSE CUSTOMER REMOVED THE DESICCANT FROM THE FIRST BOTTLE AFTER SHE PERFORMED THE COMPARISON AT THE LAB, THE REP DID NOT REQUEST CUSTOMER'S TEST STRIPS FOR EVAL. BASED ON CUSTOMER REPORTED RESULT, THE SECOND BOTTLE OF TEST STRIPS PROVIDE ACCEPTABLE PERFORMANCE. CO HAS NOT COMPLETED THIS INVESTIGATION. UPON COMPLETION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA. TIME FRAME APPROX 6 WEEKS. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO.
UNABLE TO OBTAIN AN INTRACRANIAL PRESSURE READING DURING EMERGENCY CRANIOTOMY. ICP MONITOR CABLE FOUND TO BE DEFECTIVE BY EVALUATION OF BIOMEDICAL ELECTRONICS.
HIP DISLOCATES WITH EXTENSION AND EXTERNAL ROTATION.
PT ADMITTED 9/23/96: HAD MITRAL VALVE REPLACEMENT WITH A MECHANICAL BIOPROSTHESIS IN SUMMER OF 1966. A RE-DO REPLACEMENT WAS CARRIED OUT WITH A PORCINE PROSTHESIS IN 1979. PT SUBSEQUENTLY HAS HAD INTERMITTENT/CHRONIC ATRIAL FLUTTER AND ATRIAL FIBRILLATION. RECENTLY, SHE HAS DETERIORATED SUCH THAT SHE HAS NEW YORK HEART ASSOCIATION (CLASS IV) DEPPNEA. TRANSESOPHAGEAL ECHOCARDIOGRAM TO EVALUATE THIS DECLINE SHOWED MARKED LEFT ATRIAL ENLARGEMENT WITH NORMAL LEFT VENTRICULAR SIZE AND MODERATELY SEVERE MITRAL REGURGITATION DUE TO PROSTHESIS ABNORMALITY. THE MITRAL VALVE AREA WAS 1.1 TO 1.4 CM SQUARED. THERE WAS MODERATELY SEVERE TRICUSPID REGURGITATION WITH MODERATE PULMONARY HYPERTENSION. FOR THAT REASON PT ADMITTED FOR CARDIAC CATHETERIZATION AND POSSIBLE MITRAL VALVE REPLACEMENT. NO DIRECT COMPLICATIONS OF SURGERY AND PT DISMISSED. IT WAS FELT THAT MITRAL VALVE REPLACEMENT SURGERY SHOULD BE CARRIED OUT. PT HAS CONTINUED TO SMOKE.
IMPLANT HAS FRACTURED. PT INJURY HAS NOT BEEN REPORTED.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES.
THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE DEVICE DID NOT FIT PROPERLY DOWN 512S 12MM TROCAR. THE SURGEON HAD TO "JAM IT IN" AND "YANK IT OUT." IT WAS TOO TIGHT AND WOULD PULL THE TROCAR OUT. THE DEVICE BROKE ON THE SECOND FIRING. SURGEON MAY HAVE CROSSED PREVIOUS STAPLE LINE. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. A LOUD CRACK WAS HEARD WHEN THE INSTRUMENT WAS FIRED. NO BUTTRESSING MATERIAL WAS USED. THERE WAS NO CONSEQUENCE TO THE PT.
DURING PUMPING AUGMENTATION PRESSURE DECREASED. THE CONTACT REPORTED  THAT THE MD REMOVED  THE IAB AND TRIED TO SYRINGE AIR INTO THE BALLOON BUT COULD NOT DUE TO RESISTANCE.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FROM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. THE IAB WAS RECEIVED INTACT FRO EVALUATION WITH THE BALLOON MEMBRANE NOTED TO BE ALMOST COMPLETELY WITHIN THE SHEATH TUBING. THE MEMBRANE AND INNER LUMEN WITHIN THE DEVICE WAS NOTED TO BE SEVERELY STRETCHED. IT WAS NOT POSSIBLE TO PUMP THIS IAB ON THE LABORATORY SYSTEM 90 DUE TO THE CONDITION OF THE RETURNED DEVICE. THE CONDITION OF THE DEVICE SUFFESTSF THAT THE SHEATH DID NOT FULLY EXIT THE SHEATH WHICH LED TO THR RPORTED AUGMENTATION DIFFICULTIES. DEVICE CODE LABEL:1738.
NOTE: THE INFO IN SECTION F IS SUPPLIED BY THE USER FACILITY ON MEDWATCH FORM 0000230038-1996-0010. TESTING IDENTIFIED SEVERAL FAILURES: INTERMITTENT OPEN CONDITIONS IN THE RED, WHITE, AND GREEN WIRES. CAUSE OF FAILURES WAS A BREAK IN THE WIRE INSIDE OF THE INSULATION. THE LOCATION OF THE BREAK IS AT THE POINT AT WHICH THE CABLE EXITS THE CONNECTOR HOUSING. THE BREAK PERMITTED THE ENDS OF THE WIRE TO MAKE CONTACT INTERMITTENTLY, RESULTING IN THE OPEN/INTERMITTENT CONDITION. THE POINT OF FAILURE IS A POINT WHICH MAY BE SUBJECTED TO THE MAXIMUM FLEXING FORCE OF THE ENTIRE ASSEMBLY AS IT IS THE FIRST FLEXIBLE POINT OF THE CABLE WHEN CONNECTED TO THE CONTROL UNIT. IT IS ESTIMATED BY MFR THAT DEVICE HAS BEEN IN USE FOR APPROX. 40 MONTHS. THE BREAK IS, THEREFORE, UNLIKELY TO HAVE BEEN PRESENT AT TIME OF PURCHASE. IT IS BELIEVED THAT THE CABLE WAS DAMAGED THROUGH ACCIDENT OR MISUSE, OR SIMPLY WORE OUT THROUGH NORMAL USE.
PT HAD SURGICAL ORIF OF FRACTURE L FEMUR 6/96. NOW WITH PAIN, CLICKING, AND SWELLING. 9/19/96, TO OR FOR REMOVAL BROKEN PLATE.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK ON A 3RD USE DIALYZER. EBL 140CC. THERE WAS NO PT INJURY AND THE SAMPLE WAS DISCARDED.
REVISION SURGERY REVEALED MACROMOTION AND 90 DEGREES INFERIOR ROTATION OF THE ACETABULAR CUP. THE ACETABULAR INSERT AND CANCELLOUS SCREW WERE ALSO REMOVED AT THIS TIME.
SUMMARY OF EVALUATION: THE DEVICE HAS BEEN RETAINED BY THE HOSPITAL; THEREFORE, EVALUATION OF THE DEVICE IS NOT POSSIBLE. A REVIEW OF THE DEVICE HISTORY RECORDS CAN NOT BE PERFORMED AS THE LOT CODE HAS NOT BEEN PROVIDED. ATTEMPTS TO OBTAIN THE DEVICE AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL. THE INFO PROVIDED SUGGESTS THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE BUT RATHER WOULD BE PATIENT RELATED.
EVAL OF THIS EVENT CANNOT BE PERFORMED BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO CO. THE DEVICE HAD BEEN RETAINED BY THE PT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO DISCREPANCIES. THE INFO PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THIS EVENT WOULD BE ASSOCIATED WITH THE DEVICE.
EVAL SUMMARY: FINAL ANALYSIS REVEALED DRIVE NUT WITH RUST AND CORROSION ON THE THREADED SEGMENT. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. SERIAL NUMBER PRE-DATES DRIVENUT MATERIAL CHANGE. DISCLAIMER: THIS REPORT MAY BE REQUIRED BY MEDICAL DEVICE REPORTING REGULATIONS CONTAINED IN 21 CFR SECTION 803. THESE REGULATIONS ARE VAGUE IN A NUMBER OF RESPECTS AND SUBJECT TO DIFFERENT INTERPRETATIONS. MOREOVER, THE REGULATION REQUIRE CO TO MAKE A DECISION ON REPORTING BEFORE HAVING COMPLETE INFO INCLUDING ITS OWN ANALYSIS OF RETURNED PRODUCT.
INFORMANT STATED THAT DR EXPLANTED THE VALVE AS THE PT'S VENTRICLE SIZE DID NOT COME DOWN.
EVALUATION: THE VALVE WAS RETURNED BY THE CUSTOMER REPORTING:  "VALVE TEST TO 80 MM H20". DURING INVESTIGATION SOME BIOSUBSTANCE RESIDUES WERE OBSERVED AROUND THE FLAT SPRING AND SPRING SUPPORT OF THE VALVE. HOWEVER, THE PRESSURE TESTING CONFIRMED THE PRESSURE RANGE OF THE VALVE WAS CORRECTED. THIS MEASURED PRESSURE CORRESPONDED TO THE SPEC FOR A 40 MM H20 VALVE. CO WAS UNABLE TO CONFIRM THE CUSTOMER'S COMPLAINT AND CONSIDER IT NOT VALID. TEST RESULTS INDICATE NO FAILURE.
A BLOOD LEAK WAS NOTED 3.5HRS AFTER INSERTION. THE IAB WAS REMOVED AND REPLACED. AFTER 11 HRS OF USE THIS IAB WAS ALSO REMOVED DUE TO BLOOD LEAKAGE. THE THIRD IAB WAS IN USE FOR A FEW HRS WHEN THE PT EXPIRED. THE 2ND IAB IS THE ONLY SAMPLE BEING RETURNED. PT EXPIRED DUE TO MULTIPLE PROBLEMS.
H-11-ALL UNK INFO REQUESTED BUT NOT RECEIVED. H-11-SECTION F PROVIDED BY MFR.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP. THE INSTRUMENT WOULD NOT DELIVER AND COMPRESS CLIPS TO FORM LIGATURE. A SECOND DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
EVALUATION SUMMARY INADVERTANTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NTO HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
CUSTOMER REPORTED EXPERIENCING LEAKAGE AT THE CASSETTE DURING USAGE. NO PT INJURY WAS REPORTED. NO FURTHER INFO IS AVAILABLE.
SECTION 10 A AND B. AS A RESULT OF REGULATION CHANGES EFFECTIVE 7/31/96, THIS SECTION NO LONGER APPLIES. A,B.6,B.7, H.4, AND H8. UNK-ATTEMPTED TO GET MORE DETAILS 9/11/96. H3. LABORATORY EVAL CONFIRMED THE SET TO LEAK FROM A SPLIT IN THE CASSETTE FILM AT THE INLET VALVE. THE LEAKAGE OCCURS AFTER CONTINUOUS USE INT HE PUMP; HOWEVER, THE PROBLEM IS NOT WITH THE PUMP, BUT WITH THE SET. THE CASSETTE'S SILICONE RUBBER INLET TUBING HAS BEEN OBSERVED TO MOVE WHILE IN USE. THIS HAS BEEN FOUND TO OCCUR ONLY ON THE CASSETTE AUTOMATED ASSEMBLY PROCESS. IMMEDIATE ACTION HAS BEEN TAKEN TO RESTRICT THE MFG PROCESS TO THE MANUAL PROCESS ONLY. IN ADDITION, IMPROVEMENTS TO THE MATERIAL AND AUTOMATED PROCESS HAVE BEEN DEVELOPED. A PRODUCT ADVISORY IS BEING FORWARDED TO CUSTOMERS 10/96.
THE DEVICE WAS USED DURING A THORACOSCOPIC BLEB RESECTION. IT WAS REPORTED THE SURGEON PULLED THE WHITE HANDLE AND THEN THE BLACK HANDLE OF THE DEVICE AND IT JAMMED. THE SURGEON OPENED THE DEVICE AND DISCOVERED IT HAD FIRED A FEW FORMED STAPLES AND THE CUT LINE WAS NOT COMPLETE. ANOTHER DEVICE WAS OPENED AND THE SAME DIFIICULTY TO COMPLETE THE PROCEDURE. IT WAS REPORTED NO BUTTRESSING MATERIAL WAS USED DURING THIS PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 400: DAMAGED FIRING MECHANISM. CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WERE RETURNED NON-FUNCTIONAL. THE INSTRUMENTS WERE DISASSEMBLED AND WERE FOUND TO HAVE DAMAGED FIRING MECHANISMS. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
THE PT SUSTAINED WEAKNESS IN THE MEDIAL COLLATERAL LIGAMENT. REVISION SURGERY WAS PERFORMED TO CORRECT DISLOCATION DUE TO INSUFFICIENT INSERT THICKNESS. THE THICKER INSERT PROVIDED SUFFICIENT STABILITY.
SUMMARY OF EVALUATION: THE TIBIAL INSERT WAS RECEIVED 3/10/97. EVALUATION RESULTS INDICATE THE EVENT WAS ASSOCIATED WITH THE SELECTION OF INSERT THICKNESS.
FACILITY REPORTED A BLOOD LEAK ON A 11TH USE DIALYZER. EBL 140CC. THERE WAS NO PT INJURY AND THE SAMPLE WAS DISCARDED.
GROSS RUPTURE OF DIALYZER ON ITS 4TH USE. NO BLOOD WAS RETURNED. EBL>100CC. TREATMENT WAS RESUMED WITH A NEW DIALYZER WITHOUT INCIDENT. THE SAMPLE WAS DISCARDED BY THE CLINIC. THE DIALYZER WAS REPROCESSED WITH FORMALDEHYDE AND BLEACH.
SINCE THE DIALYZER IS UNAVAILABLE FOR RETURN, IT IS DIFFICULT FOR CO TO CONDUCT A CONCLUSIVE FAILURE ANALYSIS. CO HAS INFORMED THE MFG FACTORY OF THE OCCURRENCES, AND THE PRODUCT CATALOG NUMBER HAS BEEN DOCUMENTED. CO CAN ONLY PRESUME THAT SOME FACTOR OF REPROCESSING MAY HAVE INFLUENCED THE STRENGTH OF THE FIBER.
FACILITY REPORTED A BLOOD LEAK ON A 7TH USE DIALYZER. EBL 140CC. THERE WAS NO PT INJURY AND THE SAMPLE WAS DISCARDED.
CHEST X-RAY INDICATED THAT CATHETER WAS BROKEN; CARDIAC CATHETERIZATION WAS PERFORMED ON 8/5/96 TO REMOVE CATHETER FROM RIGHT ATRIUM. 8/7/96 CATHETER LINE WAS REMOVED FROM LEFT SUBCLAVIAN AREA.
THE DEVICE WAS ANALYZED AND CO BELIEVES THAT THE CATHETER WAS BEING PINCHED BETWEEN THE CLAVICLE AND THE FIRST RIB, CAUSING THE CATHETER TO BREAK. THIS IS A KNOWN LONG-TERM COMPLICATION OF VASCULAR ACCESS PORTS. CO DOES INCLUDE A DESCRIPTION OF THIS SITUATION IN THE USER'S MANUAL OF THIS PRODUCT. CO BELIEVES THAT THE DEVICE WAS FUNCTIONING PROPERLY AS SUPPLIED TO THE HOSP. THE EVENT FREQUENCY IS NOT ADDRESSED IN THE PRODUCT LABELING AND THE EVENT IS NOT OCCURRING MORE FREQUENTLY THAN USUAL. THE EVENT SEVERITY IS ADDRESSED IN THE PRODUCT LABELING AND THE EVENT IS NOT OF GREATER SEVERITY THAN USUAL.
THE REPORTER STATES THE DEVICE WAS REVISED DUE TO PAIN.
SECTION 10 A AND B. AS A RESULT OF REGULATION CHANGES EFFECTIVE 7/31/96, THIS SECTION NO LONGER APPLIES. A,B.6,B7, H.4 AND H8. UNK-ATTEMPTED TO GET MORE DETAILS 9/10. H3. LABORATORY EVAL CONFIRMED THE SET TO LEAK FROM A SPLIT IN THE CASSETTE FILM AT THE INLET VALVE. THE LEAKAGE OCCURS AFTER CONTINUOUS USE IN THE PUMP; HOWEVER, THE PROBLEM IS NOT WITH THE PUMP, BUT WITH THE SET. THE CASSETTE'S SILICONE RUBBER INLET TUBING HAS BEEN OBSERVED TO MOVE WHILE IN USE. THIS HAS BEEN FOUND TO OCCUR ONLY ON THE CASSETTE AUTOMATED ASSEMBLY PROCESS. IMMEDIATE ACTION HAS BEEN TAKEN TO RESTRICT THE MFG PROCESS TO THE MANUAL PROCESS ONLY. IN ADDITION, IMPROVEMENTS TO THE MATERIAL AND AUTOMATED PROCESS HAVE BEEN DEVELOPED. A PRODUCT ADVISORY IS BEING FORWARDED TO CUSTOMERS 10/96.
EVENT INCLUDED IN LABELING. "AND MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED BY THE RPTR."
FACILITY REPORTED THAT 2 MINS INTO TREATMENT PT COMPLAINED OF FEELING DIZZY AND THEN IMMEDIATELY STOPPED BREATHING. THE PT BECAME CYANOTIC AND WAS PLACED IN TRENDELENBURG. THE PT WAS GIVEN NORMAL SALINE. BP 60/PALP- TO 100/PALP. 911 CALLED AND WHILE GETTING AN AIRWAY READY FOR THE PT HE BEGAN BREATHING ON HIS OWN. THE ENTIRE EPISODE LASTED APPROX 30-45 SECS. THE MD WAS NOTIFIED THE PT'S VITAL SIGNS WERE STABLE AND TREATMENT WAS RESUMED USING A DIFFERENT DIALYZER WITHOUT FURTHER INCIDENT. THE SAMPLE WAS DISCARDED BY THE CLINIC.
THE HEMOSTASIS VALVE LEAKED MORE THAN USUAL.
SECTION F WAS ALSO COMPLETED BY THE MANUFACTURER IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE LABEL CODES: 1738. THE IAB WITH SERIAL NUMBER J1419652 WAS RETURNED FOR EVALUATION WITH THE 10 FRECH, 11 INCH SHEATH/ WHITE HEMOSTASIS VALVE ASSEMBLY NOTED TO BE IN PLACE OVER THE CATHETER TUBING. VISUAL EXAMINATION REVEALED KINKS IN THE SHEATH AT THE SHEATH/SHEATH HUB JUNCTION. BLOOD WAS NOTED ON THE EXTERIOR OF THE ASSEMBLY. PROBABLY CAUSE OF DIFFICULTY: DUE TO THE CONDITION OF THE RETURNED DEVICE, IT WAS NOT POSSIBLE TO SATISFACTORILY EXAMINE THE SHEATH/HEMOSTASIS VALVE. SINCE NO ADDITIONAL INFORMATION WAS PROVIDED WITH THE DEVICE WAS RETURNED FOR EVALUATION, IT IS POSSIBLE THAT THE LEAK ORIGINATED FROM THE SHEATH/SHEATH HUB JUNCTION. ALTHOUGH CONJECTURAL, IT IS POSSIBLE THAT THE USER PERCEIVED THIS LEAK TO BE A FAULTY WHITE HEMOSTASIS VALVE. THE SHEATH TUBING IS MADE OF A SOFT MATERIAL SO AS TO NOT INJURY THE PT'S ARTERY DURING THE INSERTION PROCEDURE. THE SHEATH/SHEATH HUB JUNCTION IS MOLDED JUNCTION. IT IS POSSIBLE THAT THIS JUNCTION WAS KINKED (AS EVIDENCED BY THE CONDITION OF THE RETURNED SHEATH) DURING INSERTION LEADING TO A LEAK IN THAT AREA.
FACILITY REPORTED THAT THERE WAS A LARGE BLOOD LEAK ON A FIRST USE DIALYZER. EBL >100CC. THERE WAS NO PT INJURY REPORTED BY THE NURSE. THE SAMPLE WAS DISCARDED BY THE CLINIC.
RUPTURE OF A DIALYZER ON ITS 14TH USE. EBL 100 CC. TREATMENT WAS RESUMED WITH A NEW DIALYZER WITHOUT FURTHER INCIDENT. SAMPLE WAS DISCARDED BY THE FACILITY. THE DIALYZER WAS REPROCESSED WITH FORMALDEHYDE AND BLEACH.
SINCE THE DEVICE WAS UNAVAILABLE FOR RETURN, IT IS DIFFICULT FOR CO TO CONDUCT A CONCLUSIVE FAILURE ANALYSIS. CO HAS INFORMED THE MFG FACTORY OF THE OCCURRENCES AND THE PRODUCT CATALOG NUMBER HAS BEEN DOCUMENTED. CO CAN ONLY PRESUME THAT SOME FACTOR OF REPROCESSING MAY HAVE INFLUENCED THE STRENGTH OF THE FIBER.
REPORTEDLY, A NURSE WAS SETTING-UP TO DELIVER A 25000 UNIT OF CO'S PREMIXED CONTAINER OF HEPARIN CONNECTED TO CO'S PRIMARY SET, VIA A PUMP. THE FLOW RATE OF THE PRIMARY WAS SET AT BETWEEN 250-300ML/HR. AT SOME POINT DURING THE INFUSION THE DOCTOR REQUESTED A BOLUS OF 500ML NORMAL SALINE SOLUTION BE DELIVERED TO THE PT VIA A SECONDARY CONTAINER AND SET. THE NURSE REDUCED THE HEAD HEIGHT OF THE PRIMARY CONTAINER, DID NOT CLOSE THE ROLLER CLAMP, AND INTERRUPTED THE HEPARIN MODE SETTING THE PUMP FLOW RATE TO 999 ML/HR FOR THE NORMAL SALINE DELIVERY. THE HEPARIN WAS REPORTED TO DELIVER TO THE PT IN 1 HOUR.
SECTION 10A AND B. AS A RESULT OF REGULATION CHANGES EFFECTIVE 7/31/96, THIS SECTION NO LONGER APPLIES. A,B.6, B7,D6,H4,H.8. UNK-ATTEMPTED TO GET MORE DETAILS 9/12/96 AND 9/25/96. H3. QA LABORATORY EVAL IDENTIFIED USER ERROR AS CAUSE OF INCIDENT. THE INSTRUCTIONS IN THE MANUAL STATE NOT BE EXCEED 125 ML/HR WHEN USING AUTOMATIC PIGGYBACKING BECAUSE SIMILTANEOUS FLOW FROM PRIMARY AND SECONDARY CONTAINERS MAY OCCUR AT HIGHER RATES. H6. DEVICE UNAVAILABLE FOR FOLLOW-UP INVESTIGATION.
PT DESATURATED," WHILE USING OXYGEN CONSERVER. FURTHER INVESTIGATION BY CO REVEALED THE PT WAS NOT QUALIFIED FOR THIS DEVICE. HOWEVER, CO HAS NO CONTROL OF THE PRESCRIPTION NOR THE DEALER(S) PT SET UP. CO LABELS (DFU) REFERENCES THE DEVICE QUALIFICATIONS.
THE UNIT UNDER INVESTIGATION WAS SOLD TO CUSTOMER NO. 5049 ON 9/5/95. UNIT WAS TESTED, AS RECEIVED WITHOUT OPENING. NORMAL PULSING WAS OBSERVED WHICH INDICATED THAT THE UNIT WAS DELIVERING OXYGEN. THE CLICKING SOUND WAS NORMAL WHEN THE VALVE OPENS DURING EACH PULSE. UNIT WAS OPERATING WITHIN SPECIFICATIONS. THERE WERE NO LEAKS OBSERVED FROM THE UNIT. IT WAS NOT POSSIBLE TO CHECK FOR LEAKS FROM THE REGULATOR OR THE OXYGEN LINE SINCE THE UNIT WAS RETURNED WITHOUT THE REGULATOR AND OXYGEN LINE. THERE WAS NO EVIDENCE THAT THE CLICKING SOUND HEARD DURING PULSING COULD CONTRIBUTE TO THE PT BEING DESATURATED. PT COULD BECOME DESATURATED WHEN THE UNIT DOES NOT PULSE OR UNIT IS LEAKING. SINCE UNIT WAS PULSING AND DID NOT HAVE LEAKS, CAUSE OF FAILURE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE PT NEEDED MORE OXYGEN FLOW OR THERE WAS LEAK IN THE REGULATOR OR OXYGEN LINE.
THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE INNER LUMEN. UNDER MICROSCOPY, THE ROUGH EDGED POINT OF SEPARATION WERE IRREGULAR IN CONTOUR SUGGESTING THE INNER LUMEN BROKE. THE BROKEN PORTION OF THE INNER LUMEN HAD A WHITISH APPEARANCE, INDICATING A POINT OF STRESS. IT IS POSSIBLE THE IAB WAS RESTRAINED WITHIN THE AORTA DURING IABP. THIS WOULD HAVE RESULTED IN A CYCLICAL STRESS TO THE INNER LUMEN AND, ULTIMATELY, A BREAK. THE IAB MAY HAVE BEEN RESTRAINED AS A RESULT OF PLACEMENT WITHIN A SUBINTIMAL SPACE OR UNDERNEATH PLAQUE. IT IS ALSO POSSIBLE THAT THE INITIAL KINK IN THE INNER LUMEN WAS MADE DURING IAB INSERTION AND THAT IABP CONTINUED TO CYCLICALLY STRESS THE INNER LUMEN AT THAT POINT. DEVICE LABEL CODE: 1738.
A PT OR PTS AT THE FACILITY DIED, ALLEGEDLY DUE TO AN INFECTION. THE REPORT SUGGESTED THAT THE INFECTIOUS STRAIN P. AERUGINOSA, WAS FOUND TO BE PRESENT IN DRAIN OF THE WHIRLPOOL USED BY EACH OF THE DECEASED. THE WHIRLPOOL IS MANUFACTURED BY THIS CO AND IS THE REASON FOR THIS REPORT. A COPY OF THE FINDINGS OF THE REP OF THE FACILITY IS INCLUDED FOR INSPECTION. IT IS THE OPINION OF THE CO THAT, IF THE HOSP WAS PROPERLY DISINFECTING THE WHIRLPOOL/BATH AND USING THE RECOMMENDED DISINFECTANT AS SPELLED OUT BY THE MFR OF THE WHIRLPOOL, THE INFECTIOUS STRAIN WOULD NOT HAVE BEEN PRESENT.
FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF "NO", THEN IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUAL? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, THEN IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? N. THE INFECTIONS OCCURRED OVER A 14 MONTH PERIOD, EACH PREVIOUSLY HAD APPEARED TO BE SPORADIC. ALL PTS WERE MALES WHO HAD ACUTE LEUKEMIA. SIX PTS HAD BLOODSTREAM INFECTIONS, 2 OF WHOM ALSO HAD PNEUMONIA. ONE PT HAD BOTH URINARY TRACT AND CENTRAL CATHETER INFECTIONS. THREE PTS DIED, IN PART, DUE TO THEIR INFECTIONS. CO POSTULATE THAT THE FLAWED DESIGN OF THE DRAIN ALLOWED THE RESISTANT P. AERUGINOSA STRAIN TO BE TRANSMITTED TO PTS WHO USED THE TUB.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK ON A 9TH USE DIALYZER. EBL >100CC. THERE WAS NO PT INJURY REPORTED BY THE NURSE. THE SAMPLE WAS DISCARDED BY THE CLINIC.
ON 10/10/96, A 19 YR OLD PT UNDERGOING POST TRAUMATIC REPAIR OF THE AORTIC ARCH WAS PLACED ON CPB. PRE CPB PCO2 WAS 50 MM HG. APPROX 12 MINUTES AFTER COOLING COMMENCED, PERFUSIONIST RAN ROUTINE BLOOD GAS ANALYSIS AND DISCOVERED THAT PCO2 WAS 58 MM HG. PERFUSIONIST INCREASED SWEEP RATE. FIVE MINUTES LATER, PERFUSIONIST RAN BLOOD GAS ANALYSIS AND FOUND PCO2 TO BE 60 MM HG. SWEEP RATE WAS AGAIN INCREASED. UNDER DEEP HYPOTHERMIA, CPB WAS DISCONTINUED TO FACILITATE BLOODLESS OPERATIVE FIELD. DURING THIS TIME, PERFUSIONIST RECIRCULATED BLOOD IN CIRCUIT. A BLOOD GAS ANALYSIS OF RECIRCULATING BLOOD AFTER 48 MINUTES OF RECIRCULATION SHOWED THAT PCO2 HAD DECREASED FROM 53 MM HG TO 32 MM HG. CPB WAS RESUMED AFTER A TOTAL CROSS CLAMP TIME OF 58 MINUTES AND REWARMING COMMENCED. AS PT'S TEMPERATURE INCREASED, PCO2 CONTINUED TO INCREASE. INCREMENTAL INCREASES IN THE GAS SWEEP RATE WERE INEFFECTIVE IN REDUCING PCO2 WHICH WAS NEAR 58 MM HG AT THE TIME CPB WAS TERMINATED. THE PT'S PCO2 REMAINED IN THE 50'S FOR SEVERAL MINUTES FOLLOWING TERMINATION OF CPB BUT LATER FELL TO NORMAL LEVELS. THE PT SURVIVED THE SURGERY BUT SUCCUMBED TO MULTIPLE SYSTEM DAMAGE CAUSED BY SEVERE PHYSICAL TRAUMA AND DIED 2 DAYS LATER. PERFUSIONIST INDICATED THE DEATH WAS NOT DEVICE RELATED.
DEVICE WAS RETURNED 10/21/96 AND DECONTAMINATED 10/22/96 TO 10/24/96. PERFORMANCE TESTING WAS CONDUCTED 10/28/96. COLLECTED DATA INCLUDES O2 AND CO2 TRANSFER VOLUMES, AND MEASUREMENT OF BLOOD PATH PRESSURE DROP AND GAS INLET PRESSURE. TESTING CONFIRMED THAT THE DEVICE DID NOT ADEQUATELY REMOVE CO2 FROM THE CIRCULATING BLOOD. DURING EVAL OF THE RETURNED DEVICE, THE UNIT EXHIBITED PLASMA BREAKTGHROUGH, ALSO KNOWN AS "WETTING OUT". THIS IS THE SAME CONDITION EXPERIENCED BY THE PERFUSIONIST DURING THE CASE. PLASMA BREAKTHROUGH WILL LEAVE DEPOSITS ON THE INSIDE OF THE FIBER. EVEN AFTER DOCONTAMINATION THESE DEPOSITS WILL IMPACT GAS TRANSFER PERFORMANCE. AS A RESULT, CO2 REMOVAL WAS NEGATIVELY IMPACTED. PLASMA BREAKTHROUGH CAN OFTEN OCCUR DURING LONG AND DIFFICULT CASES. IT IS THOUGHT TO BE AFFECTED BY THE ADDITION OF DRUGS TO THE ECC AND INFLUENCED BY OTHER BIOLOGICAL FACTORS RELATED TO TRAUMA. DEVICE PERFORMANCE, ESPECIALLY WITH RESPECT TO CO2 REMOVAL, WOULD BE NEGATIVELY AFFECTED BY THE OCCURRENCE OF PLASMA BREAKTHROUGH. AN INCREASE IN SWEEP RATE WHICH RESULTED IN SOME IMPROVEMENT IN CO2 REMOVAL. VISUAL INSPECTION OF THE ENDS OF THE FIBER BUNDLE REVEALED THAT SEVERAL FIBERS WERE OCCLUDED WHICH MIGHT CAUSE INCREASED RESISTANCE TO GAS FLOW. WITH RESPECT TO PLASMA BREAKTHROUGH, THIS CONDITION COULD AFFECT THE ABILITY OF THE DEVICE TO EXCHANGE GAS AS CO2 REMOVAL IS DIRECTLY RELATED TO GAS FLOW. A REVIEW OF MFG RECORDS INDICATED THAT THIS DEVICE PASSED ALL IN-PROCESS INSPECTIONS. NO FURTHER DATA IS AVAILABLE, THIS FILE IS CLOSED
LAPAROSCOPIC NISSEN FUNDOPLICATION PERFORMED WITH A 50 F ESOPHAGEAL DILATOR, LAPRAOSCOPIC. NO PROBLEM USING DEVICE. NO MALFUNCTION. PT RETURNED TO SURGERY TWO DAYS POST OP. PERFORATION OF ESOPHAGUS. PT CONDITION IS NOW FINE.
DISCUSSION WITH NURSE AND OR MGR REVEALED THE DEVICE PERFORMED AS EXPECTED. IT IS UNKNOWN WHY THE ESOPHAGEAL PERFORATION OCCURRED. THIS IS AN INHERENT RISK OF THIS PROCEDURE. THIS IS UNKNOWN FOR INCIDENCE OF OCCURRENCE.
DEVICE LABEL CODE FOR F10. POSITION 1: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL.
ON 11/12/96, DATASCOPE WAS NOTIFIED THAT THE IAB WAS PROBABLY DISCARDED BY THE FACILITY AND WOULD NOT BE RETURNED TO DATASCOPE FOR EVALUATION. ON 2/11/97, THE FOLLOWING WAS REPORTED TO DATASCOPE. THE IAB PUMPED FOR THREE DAYS. EVENT COMPLICATIONS: UNK - REPORTED 8/29/96; NONE - REPORTED 2/11/97. PATIENT'S CURRENT STATUS: DISCHARGED - RPT'D 2/11/97.
WHEN THE DR ATTEMPTED TO REMOVE THE CATHETER ADVANCER AT THE END OF THE PROCEDURE, THE ADVANCER BURR WAS DIFFICULT TO MOVE. THE DR REMOVED THE ENTIRE SYSTEM FROM THE PT AS ONE UNIT. A DISSECTION OF THE LAD BECAME APPARENT UPON REMOVAL OF THE SYSTEM, AND THE PT WENT TO SURGERY.
DEVICE MFR EVALUATED ACTUAL DEVICE INVOLVED IN THE INCIDENT. ALTHOUGH ANNULUS OF THE BURR WAS DAMAGED, RETURNED GUIDE WIRE WAS EASILY REMOVED FROM ADVANCER. FURTHER INVESTIGATION CONFIRMED THE PRESENCE OF BLUE FIBERS TIGHTLY WOUND AROUND DRIVE SHAFT WOULD LIKELY INTERFERE WITH PROPER ROTATION OF ADVANCER. NO MATERIAL USED IN MFG PROCESS MATCH FIBERS FOUND. THEREFORE, IT WAS NOT POSSIBLE TO DETERMINE WITH CERTAINTY WHEN THE FIBERS BECAME WRAPPED AROUND DRIVE SHAFT.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK ON A 1ST USE DIALYZER. EBL >100CC. THERE WAS NO PT INJURY REPORTED BY THE NURSE. THE SAMPLE WAS DISCARDED BY THE CLINIC.
PT DESATURATED," WHILE USING OXYGEN CONSERVER. FURTHER INVESTIGATION BY CO REVEALED THE PT WAS NOT QUALIFIED FOR THIS DEVICE. HOWEVER, CO HAS NO CONTROL OF THE PRESCRIPTION NOR THE DEALER PT SET UP. CO LABELS (DFU) REFERENCES THE DEVICE QUALIFICATIONS.
THE UNIT UNDER INVESTIGATION WAS SOLD TO CUSTOMER NO. 5049 ON 11/11/95. UNIT WAS TESTED, AS RECEIVED WITHOUT OPENING. THE CLICKING SOUND WAS NORMAL WHEN THE VALVE OPENS TO DELIVER A SHOT. ALL OPERATING PARAMETERS WERE FOUND WITHIN RANGE. NO LEAKS OF ANY FORM FROM THE UNIT WERE OBSERVED. SINCE THE UNIT WAS RETURNED WITHOUT THE REGULATOR AND THE OXYGEN LINE, IT WAS NOT POSSIBLE TO CHECK FOR LEAKS FROM THE REGULATOR OR THE OXYGEN LINE. THERE WAS NO EVIDENCE THAT THE CLICKING SOUND HEARD DURING PULSING COULD CONTRIBUTE TO THE PT BEING DESATURATED. PT COULD BECOME DESATURATED WHEN THE UNIT DOES NOT PULSE OR UNIT IS LEAKING. SINCE UNIT WAS PULSING PROPERLY AND DID NOT HAVE LEAKS, CAUSE OF FAILURE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE PT NEEDED MORE OXYGEN FLOW OR THERE MAY BE LEAKS IN THE REGULATOR OR OXYGEN LINE.
MOTHER WAS ADMITTED WITH CONTRACTIONS AND PUT ON THE FETAL MONITOR. A HEART RATE OF APPROX 145 WAS BEING RECEIVED VIA THE US TRANSDUCER. THE PT AT SOME POINT WENT TO THE BATHROOM AND WHEN SHE RETURNED AND WAS PUT BACK ON THE MONITOR, NO HEART RATE COULD BE FOUND. UNKNOWN MEASURES WERE THEN TAKEN BY THE NURSING STAFF. THE BABY WAS DELIVERED STILLBORN.
THE PT, THEN 15 YRS OLD, MALE, WAS ADMITTED DUE TO TERATOMA ON 6/29/92, AND DEVELOPED HYDROCEPHALUS. VP SHUNT WAS IMPLANTED. PT RETURNED TO HOSP IN 10/96 DUE TO HEADACHES. X-RAY REVEALED A BROKEN CATHETER AT AROUND THE SIXTH RIB IN THE THORAX. THE CATHETER ONLY WAS REPLACED WITH ANOTHER DEVICE.
CO VISUALLY EXAMINED THE RETURNED PRODUCT AND TESTED FOR TENSILE STRENGTH, ULTIMATE ELONGATION AND TUBING DIMENSIONS. THE CATHETER WAS FRACTURED 6.3 INCHES FROM THE PROXIMAL END. THE FRACTURED ENDS OF THE TUBING APPEARED TO HAVE BEEN PARTIALLY WORN AWAY MOST LIKELY DUE TO ABRASION. THIS PROBABLY LED TO THE REMAINDER OF THE CATHETER WALL TEARING, RESULTING IN THE BREAK. THE TUBING MET CO'S SPECS FOR DIMENSIONS, TENSILE STRENGTH AND ULTIMATE ELONGATION.
SECTION 10 A AND B. AS A RESULT OF REGULATION CHANGES EFFECTIVE 7/31/96, THIS SECTION NO LONGER APPLIES. A,B.6, B7, H4, AND H8. UNK. ATTEMPTED TO GET MORE DETAILS 10/8. H3. LABORATORY EVAL CONFIRMED THE SET TO LEAK FROM A SPLIT IN THE CASSETTE FILM AT THE INLET VALVE. THE LEAKAGE OCCURS AFTER CONTINUOUS USE IN THE PUMP; HOWEVER, THE PROBLEM IS NOT WITH THE PUMP, BUT WITH THE SET. THE CASSETTE'S SILICONE RUBBER INLET TUBING HAS BEEN OBSERVED TO MOVE WHILE IN USE. THIS HAS BEEN FOUND TO OCCUR ONLY ON THE CASSETTE AUTOMATED ASSEMBLY PROCESS. IMMEDIATE ACTION HAS BEEN TAKEN TO RESTRICT THE MFG PROCESS TO THE MANUAL PROCESS ONLY. IN ADDITION, IMPROVEMENTS TO THE MATERIAL AND AUTOMATED PROCESS HAVE BEEN DEVELOPED. A PRODUCT ADVISORY IS BEING FORWARD TO CUSTOMERS 10/96.
THE MD HAD DIFFICULTY INSERTING THE IAB INTO THE HEMOSTASIS VALVE. THE HEMOSTASIS VALVE LEAKED MORE THAN USUAL. "MULTIPLE EVENT TO INITIAL COMPLAINT NUMBER 96-00082."
SECTION F WAS ALSO COMPLETED BY THE MANUFACTURER IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER.THE IAB WITH SERIAL NUMBER R1514816 WAS RETURNED FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY FOLDED. A CLEAR, 10 FRENCH, 6 INCH HEMOSTASIS VALVE ASSEMBLY WAS ALSO RETURNED, BUT IT WAS SEPARATE FROM THE IAB CATHETER. KINKS WERE NOTED IN THE SHEATH. VISUAL EXAMINATION REVEALED THAT THE RETURNED BLUE DILATOR WAS PRESENT THROUGH THE HEMOSTASIS VALVE. BLOOD WAS NOTED ON THE EXTERIOR OF THE SHEATH/CLEAR HEMOSTASIS VALVE ASSEMBLY. THE I.D. OF THE SHEATH AND THE O.D. OF THE CATHETER WERE MEASURED AND FOUND TO BE WITHIN CO'S MANUFACTURING SPECIFICATIONS. A SHEATH/SHEATH HUB LEAK TEST WAS PERFORMED ON THE ASSEMBLY ACCORDING TO CO'S MANUFACTURING SPECIFICATIONS. THE ASSEMBLY WAS VERIFIED TO BE WITHIN SPECIFICATION. USING A LABORATORY IAB, THE  SHEATH/HEMOSTASIS VALVE ASSEMBLY WAS LEAK TESTED IN ORDER TO DETERMINE IF THE VALVE ASSEMBLY PROHIBITED THE BACK FLOW OF WATER THROUGH THE VALVE GASKET INTO ANOTHER DEVICE. AGAIN THE ASSEMBLY PASSED THIS LEAK TEST. WHEN THE HEMOSTASIS VALVE ASSSEMBLY WAS TESTED WITH JUST A LABORATORY GUIDE IN PLACE THROUGH THE VALVE ASSEMBLY, LEAKAGE DID OCCUR. A 60 CC VACUUM WAS PULLED ON THE FOLDED MEMBRANE USING A LABORATORY SYRINGE AND A ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH THE RETURNED SHEATH/HEMOSTASIS VALVE ASSEMBLY WITHOUT DIFFICULTY. PROBABLE CAUSE OF DIFFICULTY: LABORATORY EXAMINATION OF THE RETURNED IAB AND SHEATH/CLEAR HEMOSTASIS VALVE ASSEMBLY FOUND NO DEFECTS. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTIES DURING LABORATORY EXAMINATION. IN GENERAL, DIFFICULTY ADVANCING THE IAB INTO THE SHEATH/HEMOSTASIS VALVE ASSEMBLY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: THE USER MAY HAVE NOT DRAWN A SUFFICIENT VACUUM ON THE BALLOON DURING ITS REMOVAL FROM THE BLISTER TRAY. IF DRAWN, A VACUUM MAY HAVE NOT BEEN MAINTINED THROUGHOUT THE INSERTION PROCEDURE. DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. THE PT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO THE SHEATH. DURING IAB INSERTION, THE BALLOON TIP MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY AS IT EXITED THE END OF THE SHEAT. THE CATHETER AND /OR INNER LUMEN KINKED DURING INSERTION IF THE BALLOON WAS NOT SUPPORTER BY A GUIDE WIRE. THE CATHETER WAS HELD TOO FAR BACK FROM THE SITE OF INSERTION. SINCE NO ADDITIONAL INFORMATION WAS PROVIDED WHEN THE DEVICE WAS RETURNED TO CO FOR EXAMINATION, IT IS NOT POSSIBLE TO DETERMINE THE EXACT REASON FOR THE REPORTED VALVE LEAK. LABORATORY EXAMINATION OF THE VALVE REVEALED NO LEAKS WHEN THE CATHETER WAS PRESENT, BUT EXAMINATION OF THE VALVE WITH JUST THE GUIDEWIRE PRESENT DID REVEAL A LEAK. THIS LEAK WAS DUE TO THE FACT THE VALVE GASKET BECAME OVER-STRETCHED BECAUSE OF THE PRESENCE OF THE BLUE DILATOR AND TUBING.
PT FELT AN INTENSE UNCOMFORTABLE SENSATION, IMMEDIATELY AFTER LENS WAS INSERTED AND REPORTED THAT THE LEFT EYE SWOLLEN SHUT. PT WENT TO THE WALK-IN EMERGENCY ROOM FOR TREATMENT. EMERGENCY ROOM OPHTHALMOLOGIST OBSERVED LEFT EYE TO HAVE DIFFUSE PUNCTATE KERATITIS AND CONJUNCTIVE KEMOSIS. PT ALSO WAS SEEN BY PRESCRIBING DR AND WAS FOUND TO HAVE CORRECTED VISION OF 20/20. FOLLOW-UP OF PT WITH DR SHOWED CORNEA TO BE CLEAR, VISION STILL 20/20 CORRECTED AND RESIDUAL PUNCTATE KERATITIS REMAINS AT LEVEL OBSERVED PRIOR TO OCCURRENCE OF THIS EVENT.
USER FACILITY/DISTRIBUTOR INFORMATION PROVIDED BY MANUFACTURER. INADVERTANTLY LEFT OFF ORIGINAL REPORT.
DR REPORTED THAT 2 IMPLANTS WERE MOBILE IN SITE. DR ELECTED TO REMOVE THE IMPLANTS. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENT TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE L/N WAS UNAVAILABLE FROM THE DR.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK ON A 10TH USE DIALYZER. EBL >100CC. THERE WAS NO PT INJURY REPORTED BY THE NURSE. THE SAMPLE WAS DISCARDED BY THE CLINIC.
SECTION 10 A AND B. AS A RESULT OF REGULATION CHANGES EFFECTIVE 7/31/96, THIS SECTION NO LONGER APPLIES. A,B.6, B7,H.4 AND H.8 UNK-ATTEMPTED TO GET MORE DETAILS 9/9/96. H3. LABORATORY EVAL CONFIRMED THE SET TO LEAK FROM A SPLIT IN THE CASSETTE FILM AT THE INLET VALVE. THE LEAKAGE OCCURS AFTER CONTINUOUS USE IN THE PUMP; HOWEVER, THE PROBLEM IS NOT WITH THE PUMP, BUT WITH THE SET. THE CASSETTE'S SILICONE RUBBER INLET TUBING HAS BEEN OBSERVED TO MOVE WHILE IN USE. THIS HAS BEEN FOUND TO OCCUR ONLY ON THE CASSETTE AUTOMATED ASSEMBLY PROCESS. IMMEDIATE ACTION HAS BEEN TAKEN TO RESTRICT THE MFG PROCESS TO THE MANUAL PROCESS ONLY. IN ADDITION, IMPROVEMENTS TO THE MATERIAL AND AUTOMATED PROCESS HAVE BEEN DEVELOPED. A PRODUCT ADVISORY IS BEING FORWARDED TO CUSTOMERS 10/96.
A STANDARD BROACH WAS FIRST INSERTED, BUT DURING TORQUE TEST WAS FOUND TO BE UNSTABLE AND A 13 LM BROACH WAS INSERTED AND FULLY SEATED. A 14 LM BROACH WAS THEN INSERTED, BUT COULD NOT BE FULLY SEATED. THE 13 LM BROACH WAS AGAIN INSERTED ADN FULLY SEATED. DURING INSERTION OF A 13 LM STEM THE ANTERIOR LATERAL GREATER TROCHANTERIC AREA WAS FRACTURED. THE 13 LM STEM WAS EXTRACTED AND A 2MM SMALLER STEM WAS CEMENTED IN PLACE. THIS WAS THE IMPLANTING SURGEON'S FIRST CASE USING THE DEVICE STEM.
EVAL CODES FOR SECTION H6: 100 BOTH RASP AND IMPLANT MEET SIDE AND TOP PROFILE OVERLAY REQUIREMENTS. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "N", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "N", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE PT WAS IMPLANTED WITH A PROSTHESIS ON 8/14/96. SUBSEQUENTLY THE PHYSICIAN NOTED THE DEVICE HAD MIGRATED. NO ADDITIONAL INFO REGARDING THIS OCCURRENCE THE PHYSICIAN NOTED IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
ADDITIONAL INFO IS TO BE SUBMITTED. Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IS "N" IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "Y" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. IF "N" IS EVENT GREATER SEVERITY THAN USUAL FOR PRODUCT? "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY; MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B), (3), THIS REPORT SHALL NOT BE ADMISSABLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO. MENTOR H/S HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. CO DEFERS TO THE PT'S PHYSICIAN AND TO ANY CHARACTERISTICS REFERENCED IN THE PRODUCT EVALUATION ATTACHED HERETO."
DR REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORT# M747514.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.'S OFFICE.
THE DOCTOR HAD DIFFICULTY INSERTING THE IAB INTO THE HEMOSTASIS VALVE. THE HEMOSTASIS VALVE LEAKED MORE THAN USUAL. "MULTIPLE EVENTO INITIAL COMPLAINT NUMBER 96-00082".
SECTION F WAS ALSO COMPLETED BY THE MANUFACTURER IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE LABEL CODES: 1738, 1701. THE IAB WITH SERIAL NUMBER R1514340 WAS RETURNED FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY FOLDED. IN ADDITIONO, A CLEAR, 10 FRENCH, 6 INCH HEMOSTASIS VALVE ASSEMBLY WAS ALSO RETURNED, BUT IT WAS SEPARATED FROM THE IAB CATHETER (SAME AS THE ONE USED IN 2242850 -1996-00082). KINKS WERE NOTED IN THE SHEATH. VISUAL EXAMINATION REVEALED THAT THE RETURNED BLUE DIALATOR WAS PRESENT THROUGH THE HEMOSTASIS VALVE. BLOOD WAS NOTED ON THE EXTERIOR OF THE SHEATH/ CLEAR HEMOSTASIS VALVE ASSEMBLY.THE I.D. OF THE SHEATH AND THE O.D. OF THE CATHETER WERE MEASURED AND FOUND TO BE WITHIN CO'S MANUFACTURING SPECIFICATIONS. A SHEATH/SHEATH HUB LEAK TEST WAS PERFORMED ON THE ASSEMBLY ACCORDING TO CO'S MANUFACTURING SPECIFICATIONS. THE ASSEMBLY WAS VERIFIED TO BE WITHIN SPECIFICATION. USING LABORATORY IAB, THE SHEATH/ HEMOSTASIS VALVE ASSEMBLY WAS LEAK TESTED IN ORDER TO DETERMINE IF THE VALVE ASSEMBLY PROHIBITED THE BACK FLOW OF WATER THROUGH THE VALVE GASKET INTO THE STA-GARD. AGAIN, THE ASSEMBLY PASSED THIS LEAK TEST. WHEN THE HEMOSTASIS VALVE ASSEMBLY WAS TESTED WITH JUST A LABORATORY GUIDEWIRE IN PLACE THROUGH THE VALVE ASSEMBLY, LEAKAGE DID OCCUR. A 60CC. VACUUM WAS PULLED ON THE FOLDED MEMBRANE USING A LABORATORY SYRINGE AND A ONE-WAY VALVE. WITH THE VACUUM MAINTAINED, THE FOLDED MEMBRANE EASILY PASSED THROUGH THE RETURNED SHEATH/HEMOSTASIS VALVE ASSEMBLY WITHOUT DIFFICULTY.PROBABLE CAUSE OF DIFFICULTY: LABORATORY EXAMINATION OF THE RETURNED IAB AND SHEATH/CLEAR HEMOSTASIS VALVE ASSEMBLY FOUND NO DEFECTS. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTIES DURING LABORATORY EXAMINATION. IN GENERAL, DIFFICULTY ADVANCING THE IAB INTO THE SHEATH/HEMOSTASIS VALVE ASSEMBLY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: -THE USER MAY HAVE NOT DRAWN A SUFFICIENT VACUUM ON THE BALLOON DURING ITS REMOVAL FROM THE BLISTER TRAY. -IF DRAWN, A VACUUM MAY HAVE NOT BEEN MAINTAINED THROUGHOUT THE INSERTION PROCEDURE. -DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. -THE PT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO THE SHEATH. -DURING IAB INSERTION, THE BALLOON TIP MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY AS IT EXITED THE END OF THE SHEATH. -THE CATHETER AND/OR INNER LUMEN KINKED SURING INSERTION IF THE BALLOON WAS NOT SUPPORTED BY A GUIDE WIRE. -THE CATHETER WASHELD TOO FAR BACK FROM THE SITE OF INSERTION.SINCE NO ADDITIONAL INFORMATION WAS PROVIDED WITH THE DEIVCE WAS RETURNED TO CO FOR EXAMINATION, IT IS NOT POSSIBLE TO DETERMINE THE EXACT REASON FOR THE REPORTED VALVE LEAK. AGAIN, LABORATORY EXAMINATION OF THE VALVE REVEALED NO LEAKS WHEN THE CATHETER WAS PRESENT, BUT EXAMINATION OF THE VALVE WITH JUST THE GUIDEWIRE PRESENT DID REVEAL A LEAK.
DR REPORTED THAT 2 IMPLANTS FAILED DUE TO INFECTION. PT IS REPORTEDLY FINE.
(DEVICE LABEL CODES: 1701 1738 1746). UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
RESISTANCE WAS MET WHEN ATTEMPTS WERE MADE TO MANUALLY INFLATE THE CATHETER. EVENT COMPLICATIONS: <UNK - RPT'D 8/30/96; NONE FROM THE EVENT - RPT'D 10/11/96.> PT'S CURRENT STATUS: <DISCHARGED HOME ON 9/7.>
CO AS THE MFR OF THIS DEVICE, BECAME AWARE OF TWO SEPARATE EVENTS AT THE SAME FACILITY INVOLVING 20FR INITIAL PLACEMENT GASTROSTOMY (PEG) FEEDING TUBES. THE INITIAL PROCEDURES WERE PERFORMED WITHOUT INCIDENT. SOMETIME POST PLACEMENT, THE DEVICES MIGRATED INTO THE PERITONEAL WALL REQUIRING SURGICAL REMOVAL. NEW FEEDING DEVICES WERE PLACED IN BOTH INSTANCES AND THERE WERE NO PT COMPLICATIONS. ATTEMPTS BY THE MFR TO CONTACT THE USER FACILITY HAVE BEEN UNSUCCESSFUL. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE CIRCUMSTANCES. SURROUNDING THIS EVENT. THE INSTRUCTIONS FOR USE FOR THIS DEVICE STATE: "AVOID EXCESSIVE PULLING ON THE FEEDING TUBE AS THIS MAY CAUSE THE INTERNAL BOLSTER TO EMBED AGAINST THE GASTRIC MUCOSA. THE RESULT CAN BE TISSUE NECROSIS, TUBE MIGRATION, INFECTION AND ASSOCIATED SEQUELAE. TUBING SHOULD BE MONITORED FOR POSSIBLE MIGRATION IN ACCORDANCE WITH INSTRUCTIONS. TUBE MIGRATION COULD RESULT IN THE FOLLOWING: INABILITY TO FEED, PERITONITIS, INFECTION AND ASSOCIATED SEQUELAE."
THIS INFO SHALL NOT BE CONSTRUED AS AN ADMISSION BY CO THAT THE PRODUCT(S) DESCRIBED HEREIN ARE OR WERE DANGEROUS IN ANY RESPECT, OR THAT ANY CAUSAL RELATIONSHIP EXISTS BETWEEN THESE PRODUCTS AND ANY ACTUAL OR POTENTIAL INJURY. IN ADDITION, THE SUBMISSION OF A REPORT BY CO SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED.
IT WAS REPORTED THE SWITCH EMITTED SPARKS. THE USER HAS NOT RETURNED THE UNIT TO CO FOR INSPECTION. ALL ATTEMPTS HAVE BEEN MADE TO GET MORE INFO ABOUT THE EVENT. NO DEATHS OR INJURIES HAVE BEEN REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CFR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IF YES IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED IN LABELING? Y. IF YES, IS SEVERITY OF EVENT GREATER THAN LABELED? N.
WHILE DEBONDING A CERAMIC BRACKET FROM TOOTH #10, THE CORONAL 2/3 OF THE TOOTH FRACTURED OFF. FOLLOW-UP THERAPY INCLUDED ENDODONTIC TREATMENT AND A PORCELAIN CROWN.
DENTAL ASST REPORTED THAT AN IMPLANT FAILED DUE TO INFECTION AND BONE LOSS. PT IS SAME PT AS PRIOR MDR REPORT #M753905 AND MEDWATCH REPORT #2020141-1996-230. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY WAS COMPLETED AND IT WAS FOUND ACCEPTABLE PER RELEASE CRITERIA.
THE PT WAS IMPLANTED WITH A DEVICE IN HER LEFT BREAST THAT THE PHYSICIAN LATER REMOVED DUE TO WOULD DEHISCENCE. THE PT WAS IMPLANTED WITH AN IMPLANT WITH REMOTE INJECTION SITE IN HER RIGHT BREAST ON 6/17/96. SUBSEQUENTLY THE PHYSICIAN NOTED THAT THE DEVICE HAD DEFLATED. NO ADD'L INFO REGARDING THIS OCCURRENCE THE PHYSICIAN NOTED IS AVAILABLE AT THIS TIME.
ADDITIONAL INFO IS TO BE SUBMITTED. Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "N" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y IF "Y" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. IF "N" IS EVENT GREATER SEVERITY THAN USUAL FOR PRODUCT? "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRES THEREBY; MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B), (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO. " MENTOR H/S HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. CO DEFERS TO THE PT'S PHYSICIAN AND TO ANY CHARACTERISTICS REFERENCED IN THE PRODUCT EVALUATION ATTACHED HERETO.
CO RECEIVED INFO ON AN EXPLANT REPORT THAT THE TRANSVENOUS SENSE PACE LEAD HAD A LEAD FRACTURE WHICH CAUSED INAPPROPRIATE SHOCKS TO BE DELIVERED TO THE PT.
F.4.5 THE INITIAL REPORT DID NOT INCLUDE THE RISK MANAGEMENT PHONE NUMBER. CO IS STILL UNABLE TO OBTAIN THE NAME OF THE CONTACT PERSON. CO HAS LEFT MESSAGES WITH THE USER FACILITY ON APRIL 8, 10, AND 14 BUT WITH NO REPLY FROM THE RISK MANAGEMENT DEPT. H.3 EVALUATION SUMMARY: THE LEAD WAS RETURNED SEVERED AT THE BIFURCATED JOINT. THE OUTER COIL WAS BROKEN APPROXIMATELY 12 INCHES FROM THE PACING TIP. THE LEAD BODY SHOWS SIGNS OF ABRASION AT THE LEAKAGE SITE. THIS KIND OF DAMAGE IS INDICATIVE OF A CONDITION KNOWN AS "CLAVICULAR CRUSH" WHICH RESULTS FROM AN IMPLANTATION TECHNIQUE THAT OUR USER MANUAL ADVISES AGAINST. H.6 CODE 86 = X-RAY INSPECTION.
IT WAS REPORTED THE CORD EMITTED SPARKS AND SMOKE. INSPECTION REVEALED A BREAK IN THE LINE CORD AT THE STRAIN RELIEF. THE USE OF THE FLEXIBLE STRAIN RELIEF HAS REDUCED THE BREAKAGE OF THE CORD. CO HAS ADDED A CAUTION TO THE LABELING TO NOT FLEX THE POWER SUPPLY CORD NEEDLESSLY. REMEDIAL ACTION HAS BEEN ACCOMPLISHED. NO DEATHS OR INJURIES WERE REPORTED. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CFR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IF YES, IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE OF EVENT ADDRESSED IN LABELING? Y. IF YES, IS SEVERITY GREATER THAN USUAL? N.
THE REPORT STATED THAT THE DR WAS DOING A SELECTIVE CATHERIZATION OF A DISTAL SMA FOR EMBOLIZATION OF BLEEDING. THE CATHETER BECAME FROZEN IN THE DISTAL SMA DUE TO SPASM IN THE VESSEL. THE CATHETER TIP SEPARATED FROM THE CATHETER SHAFT. THE TIP REMAINED IN THE PT AND ACTED AS AN EMBOLIC AGENT. PT WAS DOING WELL AFTER THE PROCEDURE AND SEEMED TO SUFFER NO ILL EFFECTS.
DURING THE ANALYSIS, IT WAS CONFIRMED THAT THE SHAFT HAD DETACHED WITH A JAGGED FRACTURE PROXIMAL TO THE JUNCTION WITH THE OUTER LAYER. DUE TO THE NATURE OF THE FRACTURE IT APPEARED THAT THE DEVICE FAILED WHILE IN TENSION WHEN BECAME 'FROZEN' DUE TO SPASM. ACCORDING TO THE DEVICE INFO SHEET, NOT CONTINUOUS, BUT INTERMITTENT FLUSH WAS USED. FRICTION OR RESISTANCE WAS ENCOUNTERED WITH THE CATHETER FROM THE VASCULATURE. THERE WAS A YELLOW CRYSTALLIZED SUBSTANCE (WHEN ANALYZED THIS SUBSTANCE WAS DETERMINED TO BE CONTRAST) AROUND THE FRACTURE SITE AND IN SEVERAL SPOTS OVER THE CATHETER. THE MOST PROBABLE CAUSE FOR THIS FAILURE COULD BE A RESULT OF MANEUVERING THE CATHETER AGAINST RESISTANCE AFTER IT BECAME FROZEN DUE TO THE VESSEL SPASM. FREQUENCY AND SEVERITY OF OCCURRENCE OF THIS EVENT ARE NOT ADDRESSED IN THE DEVICE LABELING. THE REPORTED EVENT IS NOT OCCURRING WITH GREATER THAN EXPECTED FREQUENCY. THE REPORTED EVENT IS NOT OCCURRING WITH GREATER THAN EXPECTED SEVERITY. THIS INFO IS BASED ON INFO SUPPLIED TO CO WITHOUT THE INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT.
DR REPORTED THAT 2 IMPLANT SITES UNDERWENT SURGICAL INTERVENTION TO PRECLUDE PROGRESSIVE BONE LOSS. SOFT TISSUE INFECTION WAS PRESENT. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORT AND MEDWATCH REPORT #2023141-1996-00235.
METHOD (86) PARTS ARE STILL IN FUNCTION AND WILL NOT BE RETURNED.
IT WAS REPORTED THE SWITCH EMITTED SMOKE. NO DEATHS OR INJURIES WERE REPORTED. THE UNIT HAS NOT BEEN RETURNED TO CO FOR INSPECTION AND MAY NOT BE. THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER 21CFR803 BECAUSE A SIMILAR EVENT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO COMPLY WITH REGULATORY LETTER 90-DT-12.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? Y. IF YES, IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE ADDRESSED IN LABELING? Y IF YES, IS SEVERITY GREATER THAN IS USUAL? N.
DURING A PROCEDURE TO DEPLOY A STENT, A BALLOON CATHETER RUPTURED AND THE PT SUFFERED A STROKE. THE INFLATION DEVICE WAS USED DURING THE PROCEDURE.
VISUAL EXAMINATION OF THE RETURNED PRODUCT REVEALED SEVERAL PISTON THREADS WITH A DISTORTED APPEARANCE. THIS WAS ATTRIBUTED TO A DROP OF SOLVENT INADVERTENTLY GETTING ON THESE THREADS DURING THE MFG PROCESS. THIS DISTORTION CREATED SOME FRICTION, BUT DID NOT LIMIT THE MOVEMENT OF THE PISTON OR THE EFFECTIVENESS OF THE DEVICE. THE PRESSURE GAUGE WAS TESTED AND FOUND TO BE ACCURATE AND FUNCTIONING PROPERLY. IT IS CO'S DETERMINATION THAT USE OF THIS DEVICE WAS UNRELATED TO THE INCIDENCE OF BALLOON RUPTURE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF CO THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
WHEN THE DR WAS REPOSITIONING THE COIL, HE HAD TROUBLE PULLING THE DEVICE. IT BROKE AND HE HAD JUST THE DELIVERY WIRE WHEN HE PULLED IT OUT OF THE CATHETER. HE WAS ABLE TO PULL OUT THE COIL WITH THE CATHETER. THERE WAS NO HARM TO THE PT.
DEVICE WAS RETURNED 11/6/96. NOT SUFFICIENT TIME TO DO ANALYSIS OF FAILURE. FOLLOW UP REPORT WILL BE SENT.
IT WAS REPORTED THE UNIT BURNED. THE UNIT HAS NOT BEEN RETURNED TO CO FOR INSPECTION AND MAY NOT BE. NO DEATHS OR INJURIES WERE REPORTED.
IS FREQUENCY OF OCCURRENCE ADDRESSED IN DEVICE LABELING? Y. IF YES, IS FREQUENCY GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE ADDRESSED IN LABELING? Y. IF YES, IS SEVERITY GREATER THAN USUAL? N.
ATTORNEY ALLEGES PLAINTIFF RECEIVED BREAST IMPLANTS ON 9/20/91 AS REPLACEMENTS. ATTORNEY ALLEGES PLAINTIFF HAS SUFFERED GRIEVOUS PERMANENT INJURIES TO HER BODY, HAS SUFFERED PHYSICAL PAIN, MENTAL ANGUISH AND PERMANENT DISFIGUREMENT.
IT WAS REPORTED THE ELECTRIC POWER SUPPLY CORD BURNED. THE UNIT HAS NOT BEEN RETURNED TO CO FOR INSPECTION AND MAY NOT BE. NO DEATHS OR INJURIES WERE REPORTED.
IS FREQUENCY OF OCCURRENCE ADDRESSED IN DEVICE LABELING? Y. IF YES, IS FREQUENCY GREATER THAN LABELED? N. IS SEVERITY OF THIS EVENT ADDRESSED IN LABELING? Y. IF YES, IS SEVERITY GREATER THAN IS USUAL? N.
THE PT WAS IMPLANTED WITH IMPLANTS ON 7/8/96. ON 7/31/96 THE PHYSICIAN NOTED THAT THE PT'S RIGHT BREAST HAD DEVELOPED AN INFECTION. NO ADD'L INFO REGARDING THIS OCCURRENCE THE PHYSICIAN NOTED IS AVAILABLE AT THIS TIME. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (EFFECTIVE DATE, 2/10/92). ANY PERCEIVED INCREASE IN FREQUENCY OF OF EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21CFR803.
ADD'L INFO IS TO BE SUBMITTED. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING: N. IF "YES", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. IF "NO", IS EVENT GREATER SEVERITY THAN USUAL FOR PRODUCT? "SUBMISSION OF THIS REPORT BY MENTOR YH/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO.
DR REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS SAME PT AS PRIOR MEDWATCH REPORT #2023141-1996-97. PT IS REPORTEDLY FINE.
METHOD (86): PART NOT RETURNED. L/N NOT AVAILABLE FROM DR.
ON 10/7/96, CO WAS INFORMED ON A DEATH CERTIFICATE THAT THE PT HAD EXPIRED DUE TO VENTRICULAR FIBRILLATION AS A CONSEQUENCE OF CARDIOMYOPATHY.
THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLEY BY CO. D8. TO DATE CO HAS NEITHER RECEIVED THE ICD NOR BEEN INFORMED THAT THE DEVICE HAS BEEN EXPLANTED. F4, 5, 2. TO DATE THE USER FACILITY HAS NOT PROVIDED CO WITH THIS INFO.
DENTAL ASST REORTED THAT THREE ABUTMENTS BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORTER M725700 AND M726701 AND MEDWATCH REPORT 2023141-1990-239.
PT HAD UNDERGONE CATARACT SURGERY ON 10/8/96, AND IMPLANTATION OF INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON NOTICED THAT THE CARTRIDGE HE USED HAD A "JUTTING OUT OF PLASTIC" AT THE END THAT HE FELT TORE THE ANTERIOR CAPSULE AND A VITRECTOMY WAS NECESSARY. THE SURGEON DISCARDED THE CARTRIDGE. THEREFORE, AN EVALUATION WAS NOT DONE.
H6, METHOD: THE LENS AND THE CARTRIDGE WERE NOT RETURNED TO CO FOR EVALUATION, SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE PRODUCTS FROM THE FACILITY WITH NO AVAIL. H6, RESULTS: PRODUCTS WERE NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. THE PT'S POSTOP VISUALLY ACUITY IS 20/70 CORRECTED AND HIS IOP IS 14MM HG. THE LENS EJECTED IN A CONTROLLED MANNER. THE CARTRIDGE WAS NOT RETURNED FOR EVALUATION, EVEN THOUGH THIS COMPLAINT WAS REPORTED TO HAVE BEEN CAUSED BY A POSSIBLE BURR ON THE CARTRIDGE. THE DR THREW THE CARTRIDGE AWAY. THE PT HAD BEEN SEEN BY A RETINAL SPECIALIST LAST YR THAT DETERMINED SHE HAD PRE-EXISTING MACULAR DEGENERATION. THE SURGEON STATED THAT THE PT'S PROGNOSIS IS GOOD.
IT WAS REPORTED THE SWITCH EMITTED SMOKE. INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROX 1967 TO 6/21/90, CO USED A SWITCH MFG BY A REPUTABLE FIRM. THE SWITCH WAS A MOMENTARY TYPE SWITCH WITH A SPRING LOADED LEVER WHICH REQUIRED BEING HELD IN THE "ON" POSITION TO MAKE CONTACT. SOMETIMES A USER WOULD NOT FULLY ENGAGE THE LEVER, ALLOWING THE CONTACTS TO REMAIN SLIGHTLY OPEN WHICH COULD INDUCE ARCING. WHEN CONSISTENTLY HELD IN THIS WAY, CARBON BUILD-UP FROM THE ARCING COULD REACH OPPOSITE POLES CAUSING THE SWITCH TO EMIT A SMALL AMOUNT OF SMOKE. THE FIRST SOLUTION WAS TO CHANGE THE CONTACT MATERIAL AND THE BODY OF THE SWITCH. THIS REDUCED THE ARCING OF THE CONTACTS AND THE CARBON TRACKING OF THE SWITCH BODY. ALTHOUGH THE SITUATION WAS IMPROVED, THE OCCASIONAL RELEASE OF A PUFF OF SMOKE WAS POSSIBLE. ON 6/21/90, CO BEGAN USING A SNAP ACTION SWITCH. THE SNAP ACTION SWITCH DOES NOT ALLOW THE CONTACTS TO BE HELD IN A SLIGHTLY OPEN POSITION. THIS EVENT IS NOT REPORTABLE UNDER 21CFR803 BECAUSE SIMILAR EVENTS WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO BE COMPLIANT WITH REGULATORY LETTER 90-DT-12. REMEDIAL ACTION HAS BEEN ACCOMPLISHED.
IS FREQUENCY OD OCCURRENCE ADDRESSED IN DEVICE LABELING? Y. IF YES, IS FREQUENCY OF THIS EVENT GREATER THAN LABELED? N. IS SEVERITY OF THIS EVENT ADDRESSED IN LABELING? Y. IF YES, IS SEVERITY GREATER THAN IS USUAL? N.
DENTAL ASST REPORTED THAT 2 ABUTMENTS BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR REPORTS #M725700 AND M275701 AND MEDWATCH REPORT #2023141-1996-238.
PT RECEIVED BREAST IMPLANTS ON 5/22/72. PT ALSO ALLEGES FROM 1973-1974 SHE EXPERIENCED PAIN RADIATING DOWN BOTH ARMS, PREDOMINENTLY THE RIGHT ARM. SHE FREQUENTLY COULD NOT CARRY OUT NORMAL DUTIES, AND OVER THE YEARS SHE GOT PROGRESSIVELY WORSE UNTIL FINALLY IN 1994 SHE WAS IN AGONY. RHEUMATOLOGIST'S LETTER STATES PT HAS AN INFLAMMATORY JOINT DISORDER. THE MAIN AFFECTED JOINTS HAVE BEEN THE LEFT KNEE AND THE RIGHT WRIST. BLOOD TESTING IS NEEDED ON A REGULAR BASIS, SHE HAS OSTEOARTHRITIS WHICH IS EVIDENT CLINICALLY AND RADIOLOGICALLY IN THE KNEES AND IN THE WRISTS. A PRELIMINARY RESULT SUGGESTS THAT RHEUMATOID FACTOR IS PRESENT AND THE PROVISIONAL WORKING DIAGNOSIS IS RHEUMATOID DISEASE. PT IS EXPERIENCING SEVERE PAINS IN HER ARMS, LEGS, HANDS AND FEET.
IT WAS REPORTED THE USER RECEIVED AN ELECTRICAL SHOCK. INSPECTION REVEALED THE BAT HANDLE BROKEN AND THE SPRING WAS MISSING. NO DEATHS OR INJURIES WERE REPORTED.
IS FREQUENCY OF OCCURENCE ADDRESSED IN DEVICE LABELING? Y. IF YES, IS FREQUENCY GREATER THAN LABELED? N. IS SEVERITY OF OCCURRENCE ADDRESSED IN LABELING? Y. IF YES, IS SEVERITY GREATER THAN LABELED? N.
PT ALLEGES RECEIVING A BREAST IMPLANT IN 1976. PT ALSO ALLEGES IT BECAME HARD BECAUSE OF RADIATION; THEREFORE SHE HAD IT REPLACED IN APPROXIMATELY 1979.
THE PT TWISTED HIS LEG WHILE AT HOME, THOUGHT HE HAD DISLOCATED BUT, SUBSEQUENT RADIOGRAPHS REVEALED THE IDENTIFIED HIP STEM'S NECK HAD BROKEN.
OSTEONICS DISCLAIMER: SUBMISSION OF INFO BY OSTEONICS UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CASUAL CONNECTION BETWEEN THE PEFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFO ACT. THE ORIGIN OF THE REPORTED EVENT INFO WAS FROM THE SUBJECT DEVICE RECIPIENT'S ATTY. BASED ON THIS, NO MED-WATCH REPORT WAS RECEIVED FROM A USER FACILITY OR A DISTRIBUTOR. IDENTIFIED DEVICE WAS NOT RETURNED TO CO FOR EVALUATION. THE IDENTIFIED DEVICE BROKE AT THE NECK AND WAS SURGICALLY REPLACED AFTER AN IMPLANTATION PERIOD OF ONE HUNDRED AND FOURTEEN (114) MONTHS. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE CURRENT PACKAGE INSERT STATES, IN PERTINENT PART "FATIGUE FRACTURE OF THE FEMORAL STEM HAS OCCURRED IN AN EXTREMELY SMALL PERCENTAGE OF CASES. STEM FRACTURE IS MORE LIKELY TO OCCUR IN THE HEAVY, PHYSICALLY ACTIVE INDIVIDUAL." THE PACKAGE CONTINUES BY STATING, "REVISION SURGERY IS SOMETIMES NECESSARY TO CORRECT ADVERSE EFFECTS." CODE 86 "OTHER" - (DEVICE MFG HISTORY RECORDS REVIEWED)
REPORTER ALLEGES PT RECEIVED BREAST IMPLANTS IN 1987. REPORTER ALSO ALLEGES PT HAD REMOVAL ON 4/11/96 DUE TO CAPSULAR CONTRACTURE.
THE UF PROVIDED THE INFO IN A DEVICE TRACKING FORM.
ON 10/9/96 CO'S EMPLOYEE WAS INFORMED OF AN EVENT THAT HAD OCCURRED IN THE PEDIATRIC ICU. CO INVESTIGATED THIS REPORT DIRECTLY WITH THE HOSPITAL AND ALSO OBTAINED INFO FROM THE FACILITY'S MEDWATCH REPORT. ACCORDING TO THE HOSPITAL, A NURSE HAD RESPONDED TO THE AUDIO ALARM OF CO'S PULSE OXIMETER THAT WAS BEING USED TO MONITOR A 9 MONTH OLD FEMALE. THE NURSE REPORTEDLY "SILENCED" THE ALARM, "CORRECTED THE SITUATION WITH THE INFANT" AND LEFT THE ROOM. (THE MEDWATCH REPORT STATES THAT THE ALARM WAS "TEMPORARILY SILENCED" BUT AN EMPLOYEE OF THE FACILITY HAS EXPRESSED BELIEF THAT THE NURSE MAY HAVE "PERMANENTLY" SILENCED THE ALARM.) ACCORDING TO THE HOSPITAL, THE PT WAS CHECKED AGAIN 5 MINUTES LATER AND THE PT READINGS WERE APPROPRIATE, AND THEN THE NURSE RETURNED "20 TO 30 MINUTES LATER" AND FOUND THE PT HAD EXPIRED. AT THE TIME OF THE LAST CHECK, THE MONITOR WAS ALLEGED TO BE "IN  PULSE SEARCH AND NOT ALARMING" AND THE FACILITY REPORTED THAT THE MONITOR'S "RED LIGHT" WAS ON.
THE PULSE OXIMETER PROVIDES BOTH AUDIO AND VISUAL ALARMS WHEN ANY OF THE USER DEFINED MONITORING PARAMETERS ARE VIOLATED. THE PULSE OXIMETER ALLOWS FOR A TEMPORARY AUDIO ALARM SILENCE OF UP TO 120 SECONDS DURATION BY MEANS OF A SINGLE PUSH OF A BUTTON. ALTERNATIVELY, THE UNIT'S AUDIO ALARM MAY BE DISABLED THROUGH A SEQUENCE OF USER ACTIONS REQUIRING DELIBERATE AND SIMULTANEOUS CONTROL PANEL MANIPULATION. THE UNIT'S AUDIO ALARM MAY BE RE-ENABLED BY A SIMILAR SERIES OF USER ACTIONS, AND THE AUDIO ALARM IS ALWAYS RESET AND RE-ENABLED UPON POWER UP OF THE PULSE OXIMETER. THE UNIT'S VISUAL ALARMS ARE ALWAYS ENABLED REGARDLESS OF THE USER DEFINED AUDIO ALARM CONDITION. THE VISUAL ALARM CONSISTS OF RED FLASHING DISPLAY INFO. FURTHERMORE, IF THE AUDIO ALARM HAS BEEN SET TO A DISABLED STATE, THIS STATE IS INDICATED TO THE USER BY A CONTINUOUSLY LIT ICON ON THE MONITOR'S FRONT PANEL CONSISTING OF THE INTERNATIONAL SYMBOL FOR ALARM WITH A SLASH THROUGH IT. THE PULSE OXIMETER OPERATORS MANUAL WARNS; "DO NOT SILENCE THE AUDIBLE ALARM OR DECREASES ITS VOLUME IF PT SAFETY COULD BE COMPROMISED." AND; "WHEN THE AUDIBLE ALARM OFF BUTTON HAS BEEN PRESSED AND THE AUDIBLE ALARM OFF INDICATOR IS FLASHING, NO AUDIO ALARM SOUNDS IN THE EVENT OF AN ADVERSE PT CONDITION. THE AUDIBLE ALARM OFF BUTTON MUST NOT BE USED IN SITUATIONS IN WHICH PT SAFETY COULD BE COMPROMISED." AND; "IN NORMAL OPERATION, THE AUDIBLE AUDIO OFF BUTTON SILENCES THE AUDIO ALARM TEMPORARILY. WHILE IT IS POSSIBLE TO DISABLE THE AUDIO ALARM BY FOLLOWING THE INSTRUCTIONS IN THIS SECTION, THIS MUST NOT BE DONE IF PT SAFETY COULD BE COMPROMISED. CO HAS BEEN INFORMED THAT THE MONITOR IN QUESTION WAS SENT TO A "THIRD PARTY TESTER". AT THE TIME THE THIRD PARTY HAD COMPLETED "90% OF THE TESTING", THEY REPORTED THAT NOTHING HAD BEEN FOUND WRONG WITH THE UNIT. CO IS CURRENTLY WORKING WITH THE REGIONAL BIOMEDICAL SERVICE FOR THE HOSPITAL TO ARRANGE RETURN OF THE UNIT FOR EVALUATION. CO WILL UPDATE THE AGENCY IF IT RECEIVES ADDITIONAL INFO OR IF THE DEVICE IS RETURNED FOR EVALUATION.
THE POLYETHYLENE BEARING INSERT COMPONENT OF THE ACETABULUM PROSTHESIS FAILED. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF CO OR ITS AFFILIATES. D6. THE EXACT SIZE IS UNKNOWN BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED. THE MFG LOT NUMBER WAS NOT PROVIDED TO CO. H4. THE MFG DATE IS UNKNOWN BECAUSE THE MFG LOT NUMBER WAS NOT PROVIDED TO CO.
REPORTER ALLEGES PT RECEIVED BREAST IMPLANTS ON 8/31/70. REPORTER ALSO ALLEGES PT EXPERIENCED PROBLEMS BEGINNING IN 1973, INCLUDING LOSS OF SENSITIVITY OF NIPPLES, HARDNESS OF BREASTS, INTERMITTENT PAIN OVER MANY YEARS, ANXIETY AND DISCOMFORT SLEEPING. PT HAD REMOVAL OF HER IMPLANTS ON 10/8/93. PHYSICIAN STATES THE PROSTHESIS WERE REMOVED BECAUSE OF REDNESS IN THE LEFT BREAST, SHOWN TO HAVE INVASIVE CARCINOMA OF THE LEFT BREAST WHICH LED TO HER DEATH.
D6 - LOT NUMBER PROVIDED (HH0544) IS INCONSISTENT WITH CATALOG NUMBER GIVEN. CONCLUSION: 68A NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN.
PT ALLEGES RECEIVING A BREAST IMPLANT ON AN UNK DATE. PT ALSO ALLEGES HER IMPLANT HAS CAUSED HER MANY PHYSICAL TROUBLES, DUE TO THE SILICONE HARDENING.
PT ALLEGES RECEIVING BREAST IMPLANTS ON AN UNK DATE AND OF AN UNK MFR. PT ALSO ALLEGES SHE IS "VERY SICK, ON SEDATIVES FOR DEPRESSION AND OTHER MEDICATION AND CERTAIN CONDITION TO LIVE WITH LUPUS." SHE ALSO ALLEGES HAVING SEIZURES ALL THE TIME, PART OF HER CHEST IS NUMB, THE TOP OF THE POCKETS WHERE THE IMPLANTS WERE PLACED HURTS AND EACH DAY SHE GETS SICKER.
SUPPLEMENTAL INFORMATION PROVIDED SHOWS DOW CORNING IS NOT THE MANUFACTURER OF THE DEVICES.
DIALYZER FIRST USE AND PREPROCESSED WITH REPROCESSOR SOLUTION. FIRST TIME PT USED DIALYZER WITH CELLULOSE FIBERS. 10-15 MINS INTO DIALYSIS, PT EXPERIENCED CHEST TIGHTNESS, SHORTNESS OF BREATH, ANXIETY, AND BACK PAIN. DIALYSIS STOPPED AND BLOOD NOT RETURNED. EBL APPROX 325 ML. PT IS OKAY.
SAMPLES FROM THE SAME LOT WERE TESTED FOR PYROGENS, ACUTE SYSTEMIC TOXICITY, INTRACUTANEOUS TOXICITY, AND HEMOLYSIS; ALL RESULTS WERE NORMAL. THE ROUTINE MFG QUALITY ASSURANCE RECORDS WERE REVIEWED FOR STERILITY AND PYROGENS; ALL RESULTS WERE NORMAL. NO CAUSE FOR THIS INCIDENT COULD BE IDENTIFIED.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 7/10/86. PT ALSO ALLEGES HAVING PAIN, HARDNESS, MISSHAPEN BREAST AND NIGHT FEVERS BETWEEN FEB. 1993 UNTIL REMOVED AND REPLACED ON 7/27/93 WITH DEVICES OF ANOTHER MFR. PHYSICIAN'S NOTE STATES ONE OF THE IMPLANTS HAD A SUSPECTED DEFECT. A CAT SCAN INDICATED BOTH IMPLANTS WERE RUPTURED; HOWEVER, UPON REMOVAL THEY WERE FOUND TO BE INTACT WITHOUT ANY EVIDENCE OF RUPTURE OR GEL BLEED.
THIS EVENT WAS REPORTED AS SEVERE MITRAL STENOSIS. NO FURTHER INFO PROVIDED.
PT HAS BILATERAL CAPSULAR CONTRACTURES. LEFT SIDE: GRADE IV AND RIGHT SIDE GRADE III. PT HAD A BILATERAL OPEN CAPSULOTOMY WITH PARTIAL CAPSULECTOMY AND REMOVAL OF SILICONE IMPLANTS, REPLACED WITH SALINE IMPLANTS.
THIS EVENT WAS REPORTED AS ENDOCARDITIS. NO FURTHER INFO PROVIDED. EXPIRATION DATE 3/1/2000.
PT UNDERWENT CATARACT SURGERY ON 10/2/96, AND IMPLANTATION OF INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON NOTICED THAT THE TIP OF THE CARTRIDGE MAY HAVE HAD A BURR ON IT CAUSING IT TO TEAR THE LENS DURING INSERTION. THE TORN LENS THEN TORE THE POSTERIOR CAPSULAR AND THE SURGEON SAID A VITRECTOMY WAS NECESSARY. NO OTHER SURGICAL PROCEDURES WERE DONE AND THERE WERE NO COMPLICATIONS NOTED.
H6. RESULTS: THE LENS WAS REPORTED TO HAVE BEEN TORN BY THE CARTRIDGE DURING INSERTION AND SUBSEQUENTLY TEARING THE POSTERIOR CAPSULE. HOWEVER, THE RETURNED LENS WAS INSPECTED AND FOUND TO HAVE NO DEFECTS OR TEARS PRESENT. THE PT'S PREOP VISUAL ACUITY WAS 20/400 AND IOP WAS 14MM. THE POSTOP VISUAL ACUITY WAS 20/100 UNCORRECTED AND IOP WAS 16MM. THE PT'S PROGNOSIS IS EXCELLENT AND SURGERY WAS A SUCCESS. THE LENS WAS RETURNED FOR EVALUATION, HOWEVER THE INJECTOR AND CARTRIDGE WERE NOT RETURNED AND COULD NOT BE EVALUATED TO DETERMINE IF THEY WERE THE CAUSE OF THIS REPORT. THE REFERENCED LENS BOX WAS RECEIVED. THE BOX CONTAINED 4 CHART LABELS, THE PT ID CARD, PT REGISTRATION CARD, AND LENS TRAY. THE LENS TRAY CONTAINED THE BASE AND TOP INSERTS, WITH THE LENS LOCATED IN BETWEEN THE INSERTS. TAPE WAS HOLDING THE LENS AND INSERTS WITHIN THE TRAY. THE INJECTOR CARTRIDGE WAS NOT RECEIVING IN THE PACKAGING. THE LENS WAS REMOVED FROM THE TRAY AND INSPECTED TO DETERMINE IF THE CARTRIDGE COULD TEAR THE LENS WHICH MAY HAVE CAUSED A POSTERIOR CAPSULE TEAR. THE LENS HAS DRIED BSS/VISCOELASTIC-TYPE RESIDUE. THE LENS WAS INSPECTED ACCORDING TO COSMETIC SPECIFICATIONS, AFTER WHICH NO DEFECTS WERE PRESENT.
THIS EVENT WAS REPORTED AS STENOSIS AND REGURGITATION. NO FURTHER INFO PROVIDED.
A COIL WAS RETURNED TO CO WITH A REPORT THAT THIS FAILURE WAS SIMILAR TO ONE REPORTED PREVIOUSLY. THE PREVIOUS REPORT WAS THAT THE COIL BROKE DURING THE PROCEDURE. NO OTHER INFO WAS AVAILABLE FROM THE DR. OR DIST.
THREE DEVICES WERE RETURNED AS A SYSTEM BUT NO INFO ABOUT THE PROCEDURE OR THE PT WAS RECEIVED. CATHETER CONTAINED A MICROCATHETER WITH A BROKEN DEVICE INSIDE THE MICROCATHETER. THE PROXIMAL END OF THE DEVICE WAS FOUND TO BE STRETCHED. AN UNK SUBSTANCE WAS FOUND AROUND THE DISTAL END OF THE GUIDING CATHETER, AS WELL AS THE DISTAL END OF THE MICRO CATHETER THAT CONTAINED THE DEVICE. THE COREWIRE OF THE DEVICE BROKE PROXIMAL TO THE MAIN COIL WELD. THE SECTION OF PLATINUM COIL OVER THE WELD HAD UNRAVELED. THE PHYSICIAN IS UNAVAILABLE FOR SEVERAL MONTHS, MAKING A REQUEST FOR MORE INFO IMPOSSIBLE AT THIS TIME. NO INDICATION OF PT INJURY WAS REPORTED, THE MALFUNCTION WAS REPORTED AS JUST THAT, A MALFUNCTION OF THE DEVICE WITH NO CONSEQUENCE TO THE PROCEDURE. BECAUSE OF THE CONDITION OF THE COIL, IT WOULD APPEAR THAT THE MAIN COIL JAMMED AT A DISTAL REGION, AND THE WIRE BROKE DUE TO EXCESSIVE MANIPULATION. FREQUENCY AND SEVERITY OF OCCURRENCE OF THIS EVENT ARE NOT ADDRESSED IN THE DEVICE LABELING. THE REPORTED EVENT IS NOT OCCURRING WITH GREATER THAN EXPECTED FREQUENCY. THE REPORTED EVENT IS NOT OCCURRING  WITH GREATER SEVERITY THAN EXPECTED.
DR REPORTED THAT AN IMPLANT FAILED TO INTEGRATE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY WAS COMPLETED AND WAS FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
PT UNDERWENT CATARACT SURGERY ON 6/24/96, AND IMPLANTATION OF INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON NOTICED THAT DURING INSERTION THE LENS EJECTED TOO QUICKLY CAUSING A POSTERIOR CAPSULE TEAR AND THE SURGEON SAID A VITRECTOMY WAS NECESSARY. THE SURGEON THEN IMPLANTED A THREE PIECE LENS AND THE PT IS DOING WELL, HER VISUAL ACUITY IS 20/25.
H6 RESULTS: THE LENS THAT WAS RETURNED TO CO HAD NO DEFECTS PRESENT. THE CARTRIDGE WAS NOT RETURNED, THEREFORE CO CANNOT DETERMINE THE CAUSE OF THIS EVENT. THE PT'S PREOP VISUAL ACUITY WAS 20/200 AND IOP WAS 14MM HG. POSTOP VISUAL ACUITY WAS 20/25 CORRECTED AND THE PRESSURE WAS NOT TAKEN. THE PT IS DOING WELL AND NO OTHER SURGICAL PROCEDURES WERE NECESSARY. THE LENS WAS RETURNED FOR EVALUATION, HOWEVER THE INJECTOR AND CARTRIDGE WERE NOT RETURNED AND THEREFORE, NOT EVALUATED. THE REFERENCED LENS BOX WAS RECEIVED. THE BOX CONTAINED 7 CHART LABELS, THE PT ID CARD, REGISTRATION CARD, ELASTIC LENS DFR, AND THE LENS TRAY. THE LENS TRAY CONTAINED THE BASE AND TOP INSERT, WITH THE LENS LOCATED IN BETWEEN THE INSERTS. TAPE WAS HOLDING THE LENS AND INSERTS WITHIN THE TRAY. NO INJECTOR CARTRIDGE WAS RECEIVED IN THE PACKAGING. THE LENS WAS REMOVED FROM BETWEEN THE INSERTS AND INSPECTED FOR ANY DEFECTS THAT MAY HAVE CAUSED THE LENS TO EJECT FROM THE CARTRIDGE IN AN UNCONTROLLED MANNER AND TEAR THE POSTERIOR CAPSULE. THE LENS HAS DRIED BSS/VISCOELASTIC RESIDUE. THE LENS WAS INSPECTED ACCORDING TO COSMETIC SPECIFICATIONS. NO DEFECTS ARE PRESENT ON THIS LENS. WITHOUT THE INJECTOR CARTRIDGE, CO IS UNABLE TO COMMENT ON ITS CONTRIBUTION TO THIS REPORT (IE. DEFECTIVE CARTRIDGE, MISALIGNED LENS, ETC.). REF. # 96-1089.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 2/4/76. PT ALSO ALLEGES HAVING REMOVAL ON AN UNK DATE, DUE TO LEAKING AND CAUSING HER ALL KINDS OF HEALTH PROBLEMS.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1977. PT ALSO ALLEGES SHE HAS SUFFERED FOR ALMOST 20 YEARS, SHE IS EXTREMELY LIMITED, HER HEALTH WORSENS DAY BY DAY AND SHE IS INFLICTED WITH EMOTIONAL DISTRESS.
PT ALLEGES SHE RECEIVED IMPLANTS ON 8/2/91. PT ALSO ALLEGES SHE HAS PAIN UP AROUND HER SHOULDER; NO OTHER SPECIFICS WERE GIVEN.
PT ALLEGES RECEIVING A BREAST IMPLANT APPROX 17 YEARS AGO(I.E. 1979) AS A REPLACEMENT. PT ALSO ALLEGES IT ENLARGED AND MOVED UP IN APRIL 1996. PT HAD REMOVAL OF DEVICE ON 10/7/96 BECAUSE IT HAD GOTTEN SO LARGE THE SKIN WAS ABOUT TO SPLIT, SHE WAS IN PAIN AND HAD DISCOMFORT.
PT ALLEGES SHE HAS PAIN AND INJURY DUE TO HER IMPLANTS; HOWEVER, NO OTHER SPECIFICS WERE GIVEN.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1988. PT ALSO ALLEGES SHE HAS SERIOUS HEALTH PROBLEMS; HOWEVER, NO SPECIFICS WERE GIVEN.
REPORTER ALLEGES PLAINTIFF RECEIVED BREAST IMPLANTS ON AN UNK DATE AND OF AN UNK MFR. REPORTED ALSO ALLEGES PLAINTIFF SUFFERED A BREAST IMPLANT RUPTURE.
PT ALLEGES RECEIVING BREAST IMPLANTS ON MARCH 6, 1978. PT ALSO ALLEGES HAVING A LUMP IN HER RIGHT BREAST AND A MAMMOGRAM THREE WEEKS AGO (I.E. AUG. 1996) THAT SHOWED HER PROSTHESIS IS LEAKING BADLY AND NEEDS TO BE REMOVED.
PT ALLEGES RECEIVING BREAST IMPLANTS IN 1973 OF AN UNK MFR. PT ALSO ALLEGES SHE BELIEVS ONE MAY BE GETTING SMALLER AND SHE THINKS IT MAY BE LEAKING. HER DR. RECOMMENDS REMOVAL AND REPLACEMENT.
DR REPORTED THAT AN ABUTMENT BROKE IN FUNCTION.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. ACCURATE MEASUREMENTS COULD NOT BE DUE TO THE MODIFICATIONS, MADE BY THE DR., TO THE COMPONENT. A REVIEW OF THE LOT  HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DR.'S OFFICE.
DENTAL ASISTANT REPORTED THAT AN IMPLANT WAS IMPINGING ON INFERIOR ALVEOLAR NERVE.
DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED DUE PT DEVELOPING PERIO DISEASE.
PT PRESENTED AT 0410 WITH DECREASED LEVEL OF CONSCIOUSNESS, BP 70/40, HEART RATE LESS THAN 30 AND SHALLOW RESPIRATIONS. CODE BLUE CALLED AND EMERGENCY TEAM RESPONDED. PT CONNECTED TO HEART MONITOR/DEFIBRILLATOR; HOWEVER, UNABLE TO DETECT HEART RHYTHM. MONITOR REFLECTED FLAT LINE EVEN THOUGH PULSES WERE PRESENT. NEW MONITOR/DEFIBRILLATOR OBTAINED, PT PLACED ON MONITOR. PT SUBSEQUENTLY BECAME PULSELESS, UNABLE TO RESUSCITATE AND EXPIRED. BIOMED TECH NOTIFIED THAT THE UNIT SHOWED NO TRACE ON MONITOR. REPLACED CABLES AND LEAD WIRES. TESTED SUSPECT CABLE ON SIMULATOR, SHOOK, WIGGLED AND JIGGLED CABLE. COULD NOT DUPLICATE PROBLEM.
WHILE PRIMING THE SET, THE ACCUSLIDE WOULD NOT STOP FLOW. THE SET WAS NOT CONNECTED TO A PT.
EVAL OF THE SET REVEALED THE FLOW STOP BALL WAS MISSING. THIS WOULD RESULT IN AN UNCONTROLLED FLOW. CHANGES TO THE INSPECTION AND TESTING PROCESS WILL BE IMPLEMENTED TO PREVENT RECURRENCE OF THE MISSING BALL. THIS REPORT WAS COMPLETED BY THE MFR. THERE IS NO PT INFO BECAUSE THE SET WAS NOT CONNECTED TO A PT. MFR'S REPORT DATE 11/8/96.
DR REPORTED THAT ONE IMPLANT FAILED OUT OF FIVE ON THE SAME ARCH, OVERDENTURE CASE, OTHER IMPLANTS SEEM OKAY. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO IS UNABLE TO REVIEW THE PRODUCT'S LOT HISOTRY SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR'S OFFICE.
PT'S TRACHEOSTOMY TUBE LEAKING AIR. CUFF FELT TO BE RUPTURED DUE TO LACK OF ABILITY TO REINFLATE. TRACH REMOVED. TRACHEA RE-INTUBATED THROUGH THE TRACHEOSTOMY STOMA WITH GREAT DIFFICULTY. PT EXPIRED.
DURING INTUBATION THE LARYNGOSCOPE BLADE BROKE OFF IN PT'S MOUTH INTERFERING WITH ABILITY TO INTUBATE AND VENTILATE THE PT. PT'S TOOTH BROKE. DURING INABILITY TO VENTILATE, PT BECAME HYPOXIC AND SUBSEQUENT CARDIAC ARREST. MICU STAFF PRESENT DURING EVENT. PT CONTINUES TO BE IN ICU POST ARREST.
BIL SEVERE CAPSULAR CONTRACTURE WITH PAIN.
SIDE RAIL CYLINDER MOUNT BROKE. RESIDENT FELL OUT OF BED. CUT TO HEAD AND FX OF FEMUR ABOVE KNEE.
REC'D LETTER UNEXPECTANTLY IN MAIL FROM PHYSICIAN WHICH INDICATES DR. WENT TO REMOVE PEG WHEN THE HUB WITHIN THE STOMACH SHEARED OFF FROM THE MAIN SHAFT, WHICH PHYSICIAN THEN ENDOSCOPIALLY REMOVED THE HUB USING AN  OVERTUBE.
#10 COULD NOT EVALUATE AS PRODUCT NOT RETURNED CONTRARY TO D9. TO DATE, USER FACILITY HAS NOT RETURNED DEVICE AFTER REPEATED PHONE REQUESTS. #11 NO MEDWATCH FORM RECEIVED. ALL INFO IN SEC A-F HAS BEEN FILLED IN BY BIPD BECAUSE THE USER FACILITY WAS UNABLE TO PROVIDE.
USER DID NOT HAVE CAP SECURE ON CONTAINER OF DEVICE PRIOR TO SHAKING. DEVICE SPLASHED OUT AND INTO EYES. NO EYE PROTECTION IN USE AT TIME OF INJURY. USER DID HAVE SOFT CONTACTS ON. USER WAS ON HER WAY TO SEE EYE DR FOR TREATMENT IF NECESSARY. EYES WERE FLUSHED WITH WATER FOR 15 MINUTES BEFORE GOING TO SEE EYE DR.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO FLUID LOSS-INPUT TUBING AND CYLINDER. ADD'L LOT/SER NO: 9143T 010.
THE SUTURE WAS APPLIED DURING AN UNSPECIFIED GYNECOLOGICAL PROCEDURE. REPORTEDLY, THE PT WAS CLOSED WITHOUT COMPLICATIONS. THE PT REQUIRED FOUR UNITS OF BLOOD IN RECOVERY. THE PT WAS MONITORED AND IT WAS DETERMINED THE BLEEDING HAD STOPPED. THE SURGEON HAS ASSOCIATED THIS COMPLICATION TO THE SUBJECT SUTURE AS HE HAS EXPERIENCED KNOTS UNTYING.
9/19/96- MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
PT SCHEDULED FOR G-TUBE REPLACEMENT. AFTER REMOVING G-TUBE FROM PT'S ABDOMEN VIA TRACTION METHOD PER DR. WITH MODERATE AMOUNT OF TENSION-THE INTERNAL BUMPER OF THE PEG TUBE NOT PRESENT.
BROKEN POLYETHYLENE ACETABULAR INSERT, LEFT THA PERFORMED IN DEC 1989. PROBLEM DISCOVERED WHEN PT WAS UNABLE TO WALK. EXAM REVEALED DISLOCATED LEFT THA. CLOSED REDUCTION UNSUCCESSFUL. UNDERWENT SURGERY 9/23/96 FOR ACETABULUM REVISION LEFT THA WITH CEMENTED CUP AND POLYETHYLENE INSERT.
DEVICE WAS RECEIVED BY CO ON 8/14/96 FOR COMPLAINT EVALUATION. UNIT WAS PRESSURIZED TO 12 PSI OF PRESSURE WHEREBY LEAKAGE WAS CONFIRMED FROM A SMALL HOLE IN THE COIL. ADDITIONALLY, RAW MATERIAL RECEIPTS SPECIFIC TO THIS DEVICE WERE REVIEWED AND NO ANOMALIES WERE NOTED. THE DEVICE HAS BEEN FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. A REVIEW OF CO'S REMAINING INVENTORY SHOWED NO STOCK WAS AVAILABLE OF THE SUSPECT LOT NUMBER.THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFORMATION OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIVISION, ITS OFFICERS, EMPLOYEES, OR AGENTS.
X-TUBE ASSM 16" X 16" DEALER CLAIMS X-TUBE BROKE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
AN OVERINFUSION OF HEPARIN OCCURRED. THE PUMP WAS SET TO DELIVER AT A RATE OF 9ML/HR AND 250MLS WAS REPORTED TO HAVE DELIVERED 5 TIMES FASTER THAN THE SET RATE. THERE WAS NO PT COMPLICATION.
THE PUMP WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND THE PUMP WAS FOUND TO MEET ALL MFR'S SPECIFICATIONS. THERE WAS NO VISUAL DAMAGED NOTED. THE ACCURACY WAS TESTED AT SEVERAL RATES AND PASSED ALL TESTS. IT IS SUSPECTED THAT THE POSSIBLE MISLOAD OF THE IV SET MAY HAVE CAUSED THE REPORTED OVERINFUSION. ADDITIONAL INSERVICING WILL BE RECOMMENDED ON PROPER LOADING OF THE IV SET PER THE DIRECTIONS FOR USE, PAGE 9, WHICH STATES, "CLOSE THE MECHANISM BY PUSHING THE ORANGE LATCH TO THE LEFT. VERIFY THE TUBING IS FULLY WITHIN THE MECHANISM AND THE AIR-IN-LINE DETECTOR...DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH". THIS REPORT WAS FILLED OUT BY MFR.
THE DEVICE WAS REMOVED FROM THE PT BEACUSE IT WOULD NOT INFLATE.
THE SUTURE WAS APPLIED DURING AN UNSPECIFIED GYNECOLOGICAL PROCEDURE. REPORTEDLY, THE PT WAS BROUGHT BACK INTO SURGERY AFTER RECEIVED FOUR UNITS OF BLOOD IN RECOVERY. A UTERINE VESSEL APPEARED TO HAVE COME UNTIED WITH 1200-1400CC OF BLOOD LOSS. THE SURGEON HAS STATED THAT THE SUBJECT SUTURE WAS USED DURING THIS PROCEDURE.
THE CYLINDERS WERE REMOVED FROM THE PT DUE TO MALFUNCTION-RUPTURED LEFT CYLINDER.
CYLINDER WAS FUNCTIONAL. CYLINDER HAD TORN FABRIC AND BULGING. TUBING WAS FUNCTIONAL.
PER THE INFO PROVIDED THROUGH MEANS OF THE PHYSICIAN/SURGEONS OPERATIVE REPORT IT STATED "MALFUNCTIONING PENILE PROSTHESIS. A PENOSCROTAL INCISION WAS MADE AND COMPONENTS OF THE OLD PROSTHESIS WERE IDENTIFIED. THERE APPEARED TO BE A LEAK IN THE RESERVOIR/PUMP CONPONENT AS THERE WAS A FAIR AMOUNT OF PERIPROSTHETIC FLUID IN THE SCROTAL POCKET. THE OLD PROSTHESIS WAS REMOVED INCLUDING ALL OF THE TIP EXTENDERS." IT WAS ALSO STATED THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MFR'S DEVICE.
ACCORDING TO THE AVAILABLE INFORMATION, THIS PENILE PROSTHESIS WAS EXPLANTED ON 9/27/96, REPORTEDLY DUE TO A MALFUNCTION. THE DATE THE DEVICE WAS IMPLANTED WAS NOT RECEIVED. IN THE RECEIVED OPERATIVE REPORT, THE PHYSICIAN STATED, "THERE APPEARED TO BE A LEAK IN THE RESERVOIR/PUMP COMPONENT AS THERE WAS FAIR AMOUNT OF PERIPROSTHETIC  FLUID IN THE SCROTAL POCKET." TWO CYLINDERS AND THE RESIPUMP WERE RECEIVED AND EVALUATED BY THE MFR. DURING FUNCTIONAL TESTING A LEAK WAS OBSERVED IN CYLINDER #2'S BLADDER, AND THE PUMP'S SERIALIZED OUTLET TUBING WAS BLOCKED. NO AIR OR LIQUID WAS ABLE TO PASS THROUGH THE SERIALIZED OUTLET. A MICROSCOPIC EXAMINATION OF THE COMPONENTS WAS PERFORMED. PATCHES OF SURFACE CRAZING WERE LOCATED ON CYLINDER #2. THE LEAKAGE SITE WAS LOCATED WITHIN ON OF THE PATCHES OF SURFACE CRAZING. THE CROSS SECTIONAL SURFACES OF THE LEAKAGE SITE WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. EXAMINATION OF THE PUMP'S SERIALIZED OUTLET SHOWED THAT CRYSTALLINE MATTER HAD FORMED ON THE SPRING AND BALL. AN UNIDENTIFIABLE SUBSTANCE WAS BLOCKING THE SERIALIZED OUTLET'S TUBING. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCE'S EVALUATION, QA CONCLUDES THE FOLLOWING: 1) LEAKAGE FROM THE SEPARATION SITE, WHILE IN-VIVO, WOULD CAUSE A DEVICE MALFUNCTION. 2) LEAKAGE OBSERVED FROM THE SURFACE CRAZING IS CONSISTENT WITH ENVIRONMENTAL STRESS FRACTURES OBSERVED WITH MEDICAL IMPLANTABLE DEVICES. VARIOUS EXTERNAL FACTORS CAN CONTRIBUTE TO THE PRESENCE AND EXTENT OF SURFACE CRAZING, HOWEVER, QA IS UNABLE TO IDENTIFY THESE FACTORS. 3) QA WAS UNABLE TO DETERMINE IF THE BLOCKED PUMP OUTLET WAS BLOCKED DURING IN-VIVO. THEREFORE, QA IS PRECLUDED FROM DETERMINING IF THE BLOCKED PUMP OUTLET WAS RELATED TO THE REASON FOR REMOVING THE DEVICE.
X-TUBE 16" X 16" DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THE FDA THAT THE DEVICE. QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REC'D MEDWATCH UNEXPECTANTLY VIA FAX FROM ANOTHER DIV. FORM INDICATES PT. SCHEDULE FOR G-TUBE REPLACEMENT. AFTER REMOVING G-TUBE FROM PT. ABDOMEN VIA TRACTION METHOD PER DR. WITH MODERATE AMOUNT OF TENSION THE EXTERNAL BUMPER OF THE PEG TUBE NOT PRESENT. EGD PROCEDURE DONE.
#10 COULD NOT EVALUATE AS PRODUCT NOT RETURNED CONTRARY TO D9. TO DATE, USER FACILITY HAS NOT RETURNED DEVICE AFTER REPEATED PHONE REQUESTS. #11 INFO IN SEC D1 AND D6 HAS BEEN FILLED IN BY CO BECAUSE THE USER FACILITY WAS UNABLE TO PROVIDE. SEC A-E IS BASED UPON ATTACHED USER FACILITY MEDWATCH FORM.
PT WAS BEING ASSISTED TO STAND FROM THE TOILET TO PIVOT INTO HER WHEELCHAIR. PT'S RIGHT CALF PRESSED AGAINST METAL WHEELCHAIR LEG HINGE, RESULTING IN A 4 CM SKIN TEAR, TRIANGULAR IN SHAPE. LEFT EXTREMITY WITH 2+ PITTING EDEMA. PT WAS SENT TO HOSP, REQUIRED SEVEN STICHES.
DURING AN ELECTROPHYSIOLOGY PROCEDURE THIS DEVICE EXPERIENCED INTERMITTENT CONTINUITY. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR ANALYSIS.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE SEAL DISENGAGED. THE SURGEON APLLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED DUE TO LOSS OF FLUID-LEFT CYLINDER. ADD'L LOT/SER NO: 0499Q 008.
THE PUMP WAS SET TO DELIVER DIPRIVAN AT A RATE OF 30M/HR. FIFTY MLS WERE INFUSED IN ONE HOUR. WHEN THE DOOR OF THE PUMP WAS OPENED IT WAS NOTED THAT THE TUBING WAS NOT COMPLETELY LOADED INTO THE MECHANISM. THERE WAS NOT PT COMPLICATION.
PUMP WAS NOT RETURNED TO THE MFR FOR EVAL. THE HOSP REPORTED THAT THEY HAD VISUALLY OBSERVED THAT THE IV SET HAD BEEN MISLOADED INTO THE PUMP MECHANISM. ADD'L INSERVICE WILL BE PROVIDED ON THE PROPER PROCEDURE FOR LOADING THE IV SET PER THE DIRECTIONS FOR USE, PAGE 9, WHICH STATES, CLOSE THE MECHANISM BY PUSHING THE ORANGE LATCH TO THE LEFT. VERIFY THE TUBING IS FULLY WITHIN THE MECHANISM AND THE AIR-IN-LINE DETECTOR "DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH". THIS REPORT WAS COMPLETED BY THE MFR. NO PT INFO WAS AVAILABLE FROM THE USER FACILITY. MFR'S REPORT DATE 11/8/96.
FAILED LEFT TKA PERFORMED APPROX 5 YRS AGO. ROUTINE FOLLOW-UP X-RAYS REVEALED SIGNIFICANT EROSION OF POSTEROMEDIAL ASPECT OF LEFT TIBIAL PLATEAU WITH EVIDENCE OF METAL EROSION AS WELL AS POLYETHYLENE EROSION. ON 9/19/96 UNDERWENT REVISION LEFT TKA EXCHANGING FEMORAL AND TIBIAL COMPONENTS.
THE PHYSICIAN INADVERTENTLY PLACED THE DILATATION CATHETER INTO THE CORONARY ARTERY WITH THE PROTECTIVE PACKAGING SHEATH INTACT. THE SHEATH THEN BECAME DISLODGED INTO THE ARTERY AND HAD TO BE REMOVED SURGICALLY.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. TYPE OF EVENT ADDRESSED IN LABELING? (SECTION F10) 1701 FOR CODE 2365, 1738 FOR CODE 1488. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSPITAL OR DISTRIBUTOR.
X-TUBE ASSM 16" X 16" DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, A PLASTIC PIECE AT THE END OF THE CANNULA BROKE OFF AND FELL INTO THE PT'S CAVITY. THE PIECE WAS REMOVED WITHOUT PT INJURY.
9/19/96 - MEDWATCH REPORT NOT RECEIVED BY MFG.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE APPROXIMATING LEVER BROKE DURING CLOSURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
ON 2/28/90 DEVICE WAS IMPLANTED. ON 3/28/91 AND 1/26/95 THE CYLINDERS WERE REVISED. ON 9/5/96 THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING.
THE PT REPORTS HE HAS EXPERIENCED MECHANICAL DIFFICULTIES WITH THE DEVICE.
LEFT TOTAL KNEE DONE 8/27/96. TIBIAL PART HAD DISPLACED; FAILED COMPONENT. PT STABILIZED.
QO AXIE W/NUT. DEALER CLAIMS THE AXLE IS MISSING THE BALL BEARINGS AND THE WHOLE CENTER SECTION CAME OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
AN OVERINFUSION OF LIPIDS OCCURRED. THE PUMP WAS SET TO DELIVER AT A RATE OF 10ML/HR AND 250MLS WAS REPORTED TO HAVE DELIVERED IN ONE AND A HALF HOURS. THERE WAS NO PT COMPLICATIONS.
THE PUMP WAS RETURNED FOR EVAL. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND THE PUMP WAS FOUND TO MEET ALL OF THE MFR'S SPECIFICATIONS. THERE WAS NO VISUAL DAMAGE NOTED. THE ACCURACY WAS TESTED AT SEVERAL RATES AND PASSED ALL TESTS. IT IS SUSPECTED THAT A POSSIBLE MISLOAD OF THE IV SET MAY HAVE CAUSED THE REPORTED OVERINFUSION. ADD'L INSERVICING WILL BE PERFORMED ON PROPER LOADING OF THE IV SET PER THE DIRECTIONS FOR USE, PAGE 9, WHICH STATES, "CLOSE THE MECHANISM BY PUSHING THE ORANGE LATCH TO THE LEFT. VERIFY THE TUBING IS FULLY WITHIN THE MECHANISM AND THE AIR-IN-LINE DETECTOR...DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH". THIS REPORT WAS FILLED OUT BY THE MFR. MFR'S REPORT DATE 11/22/96.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLLECYSTECTOMY PROCEDURE. REPORTEDLY, THE PNEUMOPERITENEUM LEAKED FROM THE INSTRUMENT. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
6/12/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE APPROXIMATING LEVER BROKE DURING CLOSURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED
PER INFO PROVIDED TO CO BY PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO "BROKEN TUBING." AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH MODEL 3-PIECE INFLATABLE PENILE PROSTHESIS. 11/4/96 -RECEIVED OPERATIVE REPORT FROM THE SURGEON/PHYSICIANS OFFICE WHICH STATED "OPERATIVE PROCEDURE: REMOVAL OF PENILE PROSTHESIS AND INSERTION OF ANOTHER PENILE PROSTHESIS; OPERATIVE FINDINGS: THE PT HAS A MALFUNCTIONING PROSTHESIS IN PLACE WITH NO FLUID IN THE SYSTEM."
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 9/17/90 AND REMOVED ON 10/28/96 DUE TO "BROKEN TUBING." IN THE RECEIVED INFORMATION THE PHYSICIAN STATED THAT THERE WAS "NO FLUID IN THE SYSTEM." THE PHYSICIAN FURTHER STATED THAT THERE WERE NO APPARENT CIRCUMSTANCES IN THE PATIENT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE. IN ADDITION THE PHYSICIAN STATED THAT THE DEVICE WAS DAMAGED DURING REMOVAL. QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PRECLUDED FROM COMMENTING ON THE CONDITION OF THE PROSTHESIS. SHOULD THE EXPLANTED DEVICE BECOME AVAILABLE, OR ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
THE VENTILATOR STOPPED WORKING WHILE ON A PT. IT SHOWED FAILLED TO CYCLE. SWITCHING THE UNIT OFF AND RESTARTING IT AGAIN, BUT IT FAILED TWICE MORE BEFORE THEY REMOVED IT FROM THE PT. THE INFANT WAS BAGGED AND THEREAFTER COMMENCED ON ANOTHER VENITLATOR WHERE HE CONTINUED TO DO WELL.
THE VENTILATOR TESTED IN THE LAB, WHERE IT WAS TURNED ON AND OFF NUMEROUS TIMES WITHOUT FAILURE, THEN RUN AT ELEVATED TEMPERATURES (104 F) FOR SEVERAL DAYS, ALSO WITHOUT ANY FAILURE. IN THE ENGINEERING LAB, THE UNIT WAS CONNECTED TO A FIXTURE WHICH POWERS THE VENTILATOR ON, CHECKS FOR AN EXHALATION SOLENOID ACTIVATION, AND THEN POWERS IF OFF AGAIN. IF AN ACTIVATION IS NOT SEEN WITHIN 10 SECONDS OF POWER-UP, THEN POWER IS KEPT ON. EACH CYCLE LASTS APPROXIMATELY 15 SECONDS. THIS ALLOWS UNATTENDED VERIFICATION THAT FALL TO CYCLE ALARMS ARE NOT GENERATED. SINCE IN THAT CASE THE EXHALATION SOLENOID IS PREVENTED FROM ACTIVATING. THIS TEST ELAPSED TIME OF 312 HOURS AND APPROXIMATELY 74.880 POWER-ON CYCLES. NO FALL TO CYCLE ALARM WAS GENERATED.
PT REPORTS PAIN, BURNING SENSATION AT TIP OF PENIS. PENIS IS ERECT ALL OF THE TIME AND THE DEVICE REINFLATES ITSELF. ADD'L LOT/SER NO: CG231 011.
THE DEVICE WAS APPLIED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT MISFIRED. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, PNEUMOPERITEUM LEAKED FROM THE TROCAR. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
TUBING LEAKED AROUND FILTER (IN-LINE) AND ALLOWED MEDICATION TO LEAK OUT OF DEVICE.
ON IPP DEVICE WAS IMPLANTED ON 11/3/82. THE CYLINDERS WERE REVISED ON 3/10/88. THE ENTIRE DEVICE WAS REMOVED AND REPLACED ON 12/7/95. INFO RECEIVED ON 10/8/96 INDICATES PT ALLEGES THAT HE EXPERIENCED MECHANICAL DIFFICULTIES. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME. ADD'L LOT/SER NO: BI342 007.
A REVISION SURRGERY HAS NOT BEEN DETERMINED AT THIS TIME.
DEALER CLAIMS MULTIPLE SYMPTOM OF CHAIR. WILL NOT GO STRAIGHT, SOMETIMES WILL NOT MOVE, SOMETIMES WILL MOVE ON ITS OWN, AND SOMETIMES WILL ONLY MOVE IN REVERSE.
LACK OF PROPER USE AND MAINTENANCE CAUSED MALFUNCTION. OWNERS MANUAL COVERS ISSUES INVOLVED. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CPP PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE. QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE EVENT OCCURRED WHEN THE THERAPIST HAD CHECKED THE PARAMETERS, WAS WALKING OUT OF THE PT'S ROOM WHEN HE NOTICED THAT THE VENTILATOR STOPPED, AND ALL THE DISPLAYS FROZE INCLUDING THE GRAPHIC DISPLAY. HE TURNED THE VENTILATOR OFF THEN ON AGAIN AND IT OPERATED CORRECTLY. THE RN WORKING IN THE ROOM APPARENTLY BUMPED THE VENTILATOR AND IT AGAIN FROZE, ALL DISPLAYS STOPPED CYCLING AND THERE WAS NO ALARM. THE VENTILATOR INOPERATIVE ALARM LED WAS ILUMLNATED. THE PT WAS NOT INJURED AS THE RT AND THE RN WERE AT THE BEDSIDE AND WERE ABLE TO VENTILATE THE PT MANUALLY.
UNIT TESTED AND RAN FOR 3 DAYS WITHOUT ANY FAILURE NOTED. PLACED IN ENVIROMENTAL CHAMBER AT 104 F WITHOUT ANY FAILURE. OPENED UNIT AND CHECKED ALL CABLES AND PCBS WITH NO PROBLEMS FOUND. THE UNIT MEETS MANUFACTURES SPECS.
PT ALLEGES THAT HE HAS EXPERIENCED MECHANICAL DIFFICULTIES. ADD'L LOT/SER NO: AQ369 010.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT CLOSE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN, THE DEVICE WAS REMOVED AS "THE DEVICE WOULDN'T PUMP UP." 1/12/96 UPON RECEPT OF THE PHYSICIAN/SURGEONS OPERATIVE NOTES IT STATED "MALFUNCTION OF PENILE PROSTHESIS, REMOVAL OF THREE PIECE PENILE PROSTHESIS, REPLACEMENT OF THREE-PIECE PENILE PROSTHESIS." "THE PT RECEIVED AMPICILLIN AND GENTAMYCIN   PRIOR TO THE START OF THE PROCEDURE."
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 9/7/93 AND REMOVED ON 9/17/96 DUE TO A "MALFUNCTION." IN THE RECEIVED INFORMATION THE PHYSICIAN STATED THAT THE PUMP WAS "NONFUNCTIONING" AND THAT THE "RESERVOIR AND CYLINDERS (WERE) EMPTY." THE PHYSICIAN ALSO STATED THAT THERE WERE NO APPARENT CIRCUMSTANCES IN THE PATIENT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE. IN ADDITION THE PHYSICIAN STATED THAT THE DEVICE WAS DAMAGED DURING THE EXPLANT PROCEDURE. QA WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PRECLUDED FROM COMMENTING ON THE CONDITION OF THE PROSTHESIS. SHOULD THE EXPLANTED DEVICE BECOME AVAILABLE, OR ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES.
FLUID INTAKE VALVE TO FILL ELASTOMERIC PUMP LEAKED AROUND ELASTIC BALLOON AND INTO THE PLASTIC ENCLOSURE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY, THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
9/19/96 - A MEDWATCH REPORT WAS NOT RECEIVED BY THE MFG. INITIAL REPORT SENT FOR FDA BY MFG.
INFO RECEIVED ON 10/8/96 INDICATES PT ALLEGES THAT HE HAS EXPERIENCED MECHANICAL DIFFICULTIES. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME. ADD'L LOT/SER NO: AB999 004.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS. ANOTHER DEVICE WAS IMPLANTED. UNABLE TO OBTAIN ADD'L INFO.
AFTER A DIRECTIONAL CORONARY ARTHRECTOMY PROCEDURE THE BALLOON RUPTURED AND A DISSECTION OF THE LEFT ANTERIOR DESCENDING ARTERY OCCURRED. THE PHYSICIAN STATED HE MAY HAVE EXCEEDED THE RATED BURST PRESSURE. THE DISSECTION WAS TREATED SUCCESSFULLY WITH A PERFUSION DILATION CATHETER. THE PT ALSO REQUIRED A PERICARDIOCENTESIS TO ALLEVIATE A CARDIAC TAMPONADE. THE PT WAS DISCHARGED HOME FOUR DAYS POST PROCEDURE. HOSPITAL HAS DISCARDED DEVICE.
THE INFO IN SECTION F WAS COMPLETED BY THE MFR. TYPE OF EVENT ADDRESSED IN LABELING?(SECTION F10). 1701 FOR CODE 1333 & 1051DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSPITAL OR DISTRIBUTOR.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS WERE SCISSORING. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
AT THE TIME OF IMPLANT AND AFTER THE PACEMAKER POCKET WAS CLOSED IT WAS NOTED THAT MAGNET APPLICATION DID NOT ELICIT VENTRICULAR PACING (DEVICE WAS  PROGRAMMED DDD). THROUGH THE USE OF THE EPR 1000 PROGRAMMER IT WAS DETERMINED THAT THE VENTRICULAR THRESHOLD AND RESISTANCE HAD CHANGED. THE POCKET WAS OPENED AND THE LEADS DISCONNECTED FROM THE PACEMAKER. THE LEADS WERE TESTED AND FOUND TO HAVE ACCEPTABLE VALUES. THE LEADS WERE RECONNECTED TO THE PACEMAKER AND THE SYSTEM APPEARED TO FUNCTION APPROPRIATELY. THE SURGEON'S CONCERN WITH LIABLITY PROMPTED HIM TO EXPLANT THIS PACEMAKER AND REPLACE IT WITH A SIMILAR DEVICE.
CO HAS ANALYZED THIS PACEMAKER AND SUBJECTED IT TO A COMPLETE FINAL ACCEPTANCE TEST AND IT PROVED TO BE WITHIN ALL ELECTRICAL SPECIFICATIONS. ALSO THE HEADER AND SET SCREW DIMENSIONS ARE AS EXPECTED. THE PACEMAKER IS NOT DEFECTIVE.
DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED. SALVAGE PROCEDURE PERFORMED.
THE PT WAS BEING FED USING A PUMP. AN UNKNOWN AMOUNT OF ENTERAL FEEDING SOLUTION WAS HUNG, AND THE PUMP WAS SET TO DELIVER 20 ML/HR. 800 ML WERE DELIVERED IN 2.5 HOURS. THERE WAS NO ILLNESS INJURY OR MEDICAL INTERVENTION. THE PT'S STOMACH WAS ASPIRATED USING AN NG TUBE. 800 CC WERE RETRIEVED.
MFG EVENT ID: RPIC 258087. CO STANDARD PROCEDURE INCLUDES SENDING THE REPORTER A MEDWATCH FORM FOR COMPLETION AND RETURN. IN THIS CASE, THE REPORTER DID NOT PROVIDE THE REQUIRED INFO FOR THE FOLLOWING SECTION: D10.
DURING AN ELECTROPHYSIOLOGY PROCEDURE THIS DEVICE EXPERIENCED INTERMITTENT CONTINUITY. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT CLOSE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
9/19/96- MEDWATCH NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
SURGERY INFO HAS NOT BEEN PROVIDED AT THIS TIME.
INFO REC'D ON 11/22/96 INDICATES SURGERY OCCURED ON 10/11/96.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLELCYSTECTOMY PROCEDURE. REPORTEDLY, THE JAWS OF THE INSTRUMENT SCISSORED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
6/26/97-SUPPLEMENTALL REPORT #2 SUBMITTED TO FDA.
THE INCIDENT OCCURRED 10/8/96, WHEN THEY WERE EXPERIENCING PROBLEMS WITH SYNCHRONIZATION WITH THE INFANT, THE INFANT WAS HAVING PERIODIC BREATHING. THE VENTILATOR DISPLAYED 200 BREATHS PER MIN FOLLOWED BY A CLICKING NOISE, LOW PRESSURE ALARM, AND DECREASED CYCLING. THE HOSP STATED THAT IT WOULD GIVE THE MANDATORY BREATHS BUT NOT THE SYNCHRONIZED BREATHS. THE INFANT WAS MALE, 26 WK GESTATIONAL AGE POST INTRACRANIAL BLEED. THE INFANT HAD BEEN ON THE VENTILATOR LESS THEN 24 HRS PLACED ON AT 4:30 PM TO THEY CHANGED VENTILATOR AT 7:00 AM. THERE WERE NO LASTING EFECTS TO THE INFANT AS A RESULT OF THIS EVENT AND THE INFANT WAS LATER EXTUBATED AND OFF OF VENTILATORY SUPPORT.
AT POWER UP THE UNIT WOULD RESET AFTER INITALIZING THE FRONT PANEL. VOLTAGES WERE TAKEN AT THE CONTROL PCB TEST POINTS AND THE 5 VOLTS SUPPLY WAS FOUND TO BE LOW AT 4.65 VOLTS WITH THE DISPLAYS ON CAUSING A RESET TO THE PROCESSOR AND TURNING OFF THE DISPLAYS WHERE THE 5 VOLT SUPPLY WOULD TURN TO 4.9+ VOLTS CAUSING THE CYCLE TO RESTART. WHILE TAKING VOLTAGE READINGS IT WAS NOTICED THAT THE 5 VOLT PIN AT THE CONTROL PCB POWER SUPPLY CONNECTOR WAS NOT PROPERLY SEALED IN THE CONNECTOR HOUSING. PUSHING THIS PIN BACK IN CAUSED THE 5 VOLT SUPPLY TO BE STEADY AT 4.9+ VOLTS AND RETURNED THE UNIT TO NORMAL OPERATION. AT POWER UP THE UNIT WOULD RESET AFTER INITALIZING THE FRONT PANEL. VOLTAGES WERE TAKEN AT THE CONTROL PCB TEST POINTS AND THE 5 VOLT SUPPLY WAS FOUND TO BE LOW AT 4.65 VOLTS WITH THE DISPLAYS ON CAUSING A RESET TO THE PROCESSOR AND TURNING OFF THE DISPLAYS WHERE THE 5 VOLT SUPPLY WOULD RETURN TO 4.9 + VOLTS CAUSING THE CYCLE TO RESTART. WHILE TAKING VOLTAGE READINGS IT WAS NOTICED THAT THE 5 VOLT PIN AT THE CONTROL PCB POWER SUPPLY CONNECTOR WAS NOT PROPERLY SEATED IN THE CONNECTOR HOUSING. PUSHING THIS PIN BACK IN CAUSED THE 5 VOLT SUPPLY TO BE STEADY AT 4.9+ VOLTS AND RETURNED THE UNIT TO NORMAL OPERATION.
THE CUFF WAS REMOVED FROM THE PT AND REPLACED BECAUSE IT WAS TOO SMALL.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. REPORTELDY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
9/19/96- MEDWATCH NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT. THE CLINICAL PRODUCT WAS NOT RETURNED FOR CO'S EVAL.
PARAMEDICS ATTENDED TO A PULSELESS NONE BREATHING PT SAID TO HAVE EXPERIENCED A SEIZURE. FINE VENTRICULAR FIBRILLATION WAS DIAGNOSED AND TWO COUNTERSHOCKS WERE ADMINISTERED. THE PT DID NOT RESPOND. THE PT WAS LOADED AND TRANSPORTED TO THE HOSPITAL. ENROUTE TO THE HOSPITAL, A THIRD COUNTERSHOCK WAS ATTEMPTED. THE DEVICE LOW BATTERY ALARM CAME ON BRIEFLY, THE UNIT LOST POWER AND COULD NOT BE CHARGED. THE AMBULANCE DID NOT HAVE A BACK UP BATTERY ON HAND BUT PARAMEDICS WERE ABLE TO MONITOR THE PT WITH THE REMAINING ENERGY LEFT IN THE BATTERY. CPR AND RESUSCITATION EFFORTS WERE CONTINUED HOWEVER THE PT WAS NOT RESUSCITATED.
CO EVALUATED THE DEVICE AND OBSERVED NORMAL OPERATION DURING PERFORMANCE AND FUNCTIONAL TESTING. THE FACILITY'S BATTERIES WERE TESTED AND OBSERVED TO HAVE LOW BATTERY CAPACITY. THE FACILITY CLAIMS TO HAVE A BATTERY MAINTENANCE PROGRAM IN PLACE, HOWEVER, NO DOCUMENTATION WAS PRODUCED TO VERIFY THEIR PROCEDURES. THE FACILITY'S BATTERY INVENTORY WAS REPLACED AND MAINTENANCE PROCEDURES WERE REVIEWED WITH THE CUSTOMER.
THE PRODUCT WAS APPLIED DURING A CABG PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SUTURE. THE  HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/19/96 - MEDWATCH NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT CLOSE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITALHAS REPORTED THAT NO PT INJURY OCCURRED.
INFO RECEIVED ON 11/6/96 INDICATES A CUFF WAS REMOVED FROM THE PT ON 9/20/96, DUE TO RECURRING INCONTINENCE, AND REPLACED. CO HAS REQUESTED ADD'L INFO.
PT EXPERIENCED ASTHMA EVENT. DEVICE WAS REPORTED AS NOT DELIVERING MEDICATION TO PT.
DEVICE HAS NOT BEEN RETURNED FOR EVAL. AN EXAMINATION IS EXPECTED TO OCCUR IN THE FUTURE.
THE PT UNDERWENT THE CVS PROCEDURE AND ONE TRANSCERVICAL PASS WAS MADE. THE PT SPONTANEOUSLY ABORTED AT 14 WEEKS GESTATION.
CO HAS RECEIVED ADDITIONAL INFORMATION FROM CHIEF STENOGRAPHER, AT THE USER FACILITY. FURTHER INVESTIGATION AT THE USER FACILITY FOUND THAT THE SPONTANEOUS PREGNANCY LESS REPORTED WAS NOT DUE TO THE USE OF A CO'S PRODUCT DURING THE CVS PROCEDURE AND WAS FILED IN ERROR.
THE DEVICE OVERDELIVERED. THE PT HAD DARK MUCOSA AND A GI BLEED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
CO STANDARD PROCEDURE INCLUDES SENDING THE REPORTER A MEDWATCH FORM FOR COMPLETION AND RETURN. IN THIS CASE, THE REPORTER HAS NOT YET RETURNED THE COMPLETED FORM. THUS THE REQUIRED INFO FOR THE FOLLOWING SECTIONS IS NOT AVAILABLE: A2, A4; B2, B3, B6, B7; D4, D9, D10; AND F2, F6-F13.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE--PUMP MALFUNCTION.
DURING A PTCA PROCEDURE THE BALLOON OF THIS DEVICE LEAKED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
THE DEVICE WAS APPLIED DURING A CYSTECTOMY WITH ILEOCONDUIT PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM. THE SURGEON COMPLETED THE PROCEDURE BY MANUAL SUTURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
ON 5/18/88 AN AUS DEVICE WAS IMPLANTED. ON 3/15/93 THE BALLOON WAS REVISED. ON 11/15/95 AND 3/1/96 THE CUFF WAS REVISED. ON 9/12/96 THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE--PUMP NOT WORKING.
PREVIOUS MITRAL RING IMPLANTED 4/12/91 WITH QUINTUPLE CORONARY BYPASS GRAFT. LATE SUMMER 1996, PT EXPERIENCED RATHER SUDDEN ONSET OF SHORTNESS OF BREATH, ABRUPTLY WITH PALPATATIONS. SEEN IN OFFICE, CONGESTIVE HEART FAILURE WITH ATRIAL FIBRILLATION. CORONARY ANGIOGRAM REVEALS 3 PLUS CORONARY ARTERY DISEASE, MITRAL REGURGITATION AND AORTIC VALVE STENOSIS. PLANNED SURGERY, REPLACE BOTH MITRAL (PROSTHETIC) AND AORTIC VALVES AND RE-DO QUAD CORONARY ARTERY BYPASS GRAFT. PT EXPERIENCED MULTIPLE SEVERE COMPLICATIONS AND EXPIRED ON THE TENTH POST-OP DAY. HE WAS A VERY POOR CARDIAC RISK FOR THIS SURGERY, BUT HE AND HIS FAMILY REQUESTED THE PROCEDURES TO BE PERFORMED.
EVAL RESULTS INDICATE THE EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH MALIGNMENT AND INSUFFICIENT CORTICAL SUPPORT.
NO PT INJURY. DEVICE WAS REPORTED TO OVERHEAT AND THE TOP OF THE ENCLOSURE WAS MELTED.
ON 7/23/92 AN AUS DEVICE WAS IMPLANTED. ON 10/13/95 THE CUFF WAS REVISED. ON 9/27/96 THE CUFF AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO CONTROL PUMP FAILURE-FRACTURED AT CONNECTOR.
DURING THE PROCEDURE THE PROXIMAL TIP OF THE DEVICE LEAKED. THE DEVICE WAS REMOVED AND REPLACED. THERE IS NO REPORT OF PT INJURY. THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
THE BALLOON WAS REMOVED FROM THE PT AND REPLACED DUE TO HOLE IN BALLOON.
CENTRAL VENOUS ACCESS ESTABLISHED PREOP BY ANESTHESIOLOGIST USING PERCUTANEOUS SHEATH (10/29). SIDE PORT TUBING WAS CONNECTED AT LUER LOCK PER MFR DIRECTION. ON 10/30, THE SIDE PORT WAS REMOVED AND A TRIPLE LUMEN CATHETER INSERTED THROUGH THE SHEATH. THERE WAS NO LUER-LOCK AT THIS ATTACHMENT. THE TRIPLE LUMEN WAS IMMOBILIZED WITH SKIN SUTURES. WHEN THE NURSE WENT TO REMOVE THE CATHETER, SUTURES WERE REMOVED FROM THE HUB OF TRIPLE LUMEN AND THE CATHETER REMOVED. THE SHEATH REMAINED IN PLACE. THE SUTURE HOLDING THE SHEATH REMOVED AND SHEATH PULLED. THE PT CODED AND DID NOT RESPOND TO RESUSCITATION ATTEMPTS.
EVAL SUMMARY: FINAL ANALYSIS REVEALED DRIVE NUT WITH RUST AND CORROSION ON THE THREADED SEGMENT. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. S/N PRE-DATES DRIVENUT MATERIAL CHANGE. THIS REPORT MAY BE REQUIRED BY MEDICAL DEVICE REPORTING REGULATIONS CONTAINED IN 21 CFR SECTION 803. THESE REGULATIONS ARE VAGUE IN A NUMBER OF RESPECTS AND SUBJECT TO DIFFERENT INTERPRETATIONS. MOREOVER, THE REGULATIONS REQUIRE UP TO MAKE A DECISION ON REPORTING BEFORE HAVING COMPLETE INFO, INCLUDING CO'S OWN ANALYSIS OF RETURNED PRODUCT.
A CCPD (CONTINUOUS CYCLING PERITONEAL DIALYSIS) TUBING SET LEAKED AT THE CONNECTOR. THERE WAS NOT PT INJURY, BUT THE PT WAS TREATED PROPHYLACTICALLY WITH ANTIBIOTICS.
NO SAMPLE WAS RETURNED TO MFR FOR EVALUTION.
THE DEVICE INFO ORIGINALLY PROVIDED WAS FOR THE REVISION COMPONENTS THAT WERE IMPLANTED. IT DID NOT REFLECT THE DEVICES THAT WERE REVISED. SUMMARY OF EVALUATION: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS THEY HAVE NOT BEEN RETURNED TO HOWMEDICA. THE CATALOG NUMBERS AND LOT CODES HAVE NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE, CATALOG NUMBERS AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL.
IT WAS REPORTED THAT DURING USE, THE PUMP'S PURGE FAILURE ALARMS ACTIVATED. THEY CHANGED TRIGGER MODES, BUT THE ALARMS PERSISTED. THE PT WAS TRANSFERRED TO ANOTHER PUMP, AND THERE WERE NO PT COMPLICATIONS.
THE SVC REP INVESTIGATED THIS INCIDENT ON 10/29/96. THE PUMP ASSEMBLY WAS REPLACED AND THE PUMP WAS LEAK TESTED. A BROKEN CASTER WAS FOUND AND WAS REPAIRED. A FUNCTIONAL TEST WAS PERFORMED ON THE UNIT AND ALL VOLTAGES WERE CHECKED. THE PUMP FUNCTIONED NORMALLY.
AN AUS DEVICE WAS IMPLANTED ON 10/17/94. THE PUMP WAS REVISED ON 12/19/94. ON 10/2/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT, DUE INFECTION, AND REPLACED.
AT APPROX 5:45 AM ON 11/2/96 THE RESIDENT WAS FOUND UNRESPONSIVE AND CYANOTIC. UPON INVESTIGATION IT WAS DETERMINED THAT THE VENTILATOR HAD DISCONNECTED FROM THE TRACH. NO ALARMS SOUNDED. THE PT WAS TRANSPORTED TO A HOSP WHILE BEING MANUALLY VENTILATED.
AN AUS DEVICE WAS IMPLANTED ON 6/22/95. THE CUFF WAS REMOVED ON 2/29/96. A CUFF WAS REIMPLANTED ON 5/9/96. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 10/7/96, DUE TO URETHRAL DIVERTICULITIS PROXIMAL TO CUFF, AND REPLACED.
NOTE: EVALUATION OF THIS OCCURRENCE IS THE RESPONSIBILITY OF THE PRODUCT MFR. ACCORDING TO THIS MFR'S PROCEDURES, ALL INFO CONCERNING THIS EVENT AND/OR THE DEVICE COMPONENTS REC'D HAVE BEEN RETURNED TO THE SENDER. (SEE SECTION B-5)
NOTE: EVALUATION OF THIS OCCURRENCE IS THE RESPONSIBILITY OF THE PRODUCT MFR. ACCORDING TO THIS MFR'S PROCEDURES, ALL INFO CONCERNING THIS EVENT AND/OR THE DEVICE COMPONENTS REC'D HAVE BEEN RETURNED TO THE SENDER. (SEE SECTION B-5).
4/4/97 - UPON RECEIPT OF ADDITIONAL INFO PROVIDED BY THE PHYSICIAN/SURGEON, THE DEVICE REMOVED WAS A NON-MENTOR MFG DEVICE. NOTE: DETERMINATION OF REPORTABILITY AND CATEGORIZATION OF THIS EVENT WAS MADE ACCORDING TO THIS MFRS POLICIES AND PROCEDURES AND THE INFO REC'D IN COMPLIANCE WITH MEDICAL DEVICE REPORTING REGULATIONS. THESE DETERMINATIONS ARE NOT INTENDED TO EVALUATE THIS OCCURRENCE OR SUGGEST A CAUSE (REF. SECTIONS B1, B2, H1).
4/4/97 - UPON RECEIPE OF ADDITIONAL INFO PROVIDED BY THE PHYSICIAN/SURGEON, THE DEVICE REMOVED WAS A NON-MENTOR MFG DEVICE. NOTE: DETERMINATION OF REPORTABILITY AND CATEGORIZATION OF THIS EVENT WAS MADE ACCORDING TO THIS MFRS POLICIES AND PROCEDURES AND THE INFO REC'D IN COMPLIANCE WITH MEDICAL DEVICE REPORTING REGULATIONS. THESE DETERMINATIONS ARE NOT INTENDED TO EVALUATE THIS OCCURRENCE OR SUUGEST A CAUSE (RE. SECTIONS B1, B2, H1).
A BALLOON RUPTURED ON THE FIRST INFLATION DURING AN ANGIOPLASTY OF A CALCIFIED VENOUS LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATION. THIS DEVICE HAS NOT BEEN RETURNED FOR EVAL. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PARCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. FOLLOW UP REVEALED THIS BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE. IN EVALUATING THE PRODUCT, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "DO NOT EXCEED THE NORMAL PRESSURE PRINTED ON THE PRODUCT LABEL. NEVER MANIPULATE THE CATHETER WITH THE BALLOON INFLATED THE INTEGRITY OF ALL BALLOON CATHETERS MAY BE COMPROMISED BY SHARP OBJECTS OR SURFACES. NOT RECOMMENDED FOR USE IN CALCIFIED LESIONS".
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROMT HE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
PER THE INFO TO CO BY MEANS OF THE PT'S REP, THE DEVICE WAS REMOVED DUE TO AN "INFECTION". ADDITIONALY IT WAS REPORTED THAT "DUE TO SCAR TISSUE CREATED BY THE PT'S EXPERIENCE WITH THE FIRST DEVICE, HE HAS BEEN TOLD HE IS A CANDIDATE TO HAVE A REPLACEMENT DEVICE".
ADD'L INFO WAS PROVIDED IN SECTION D-6. ACCORDING TO THE REC'D INFO, THIS PENILE PROSTHESIS WAS IMPLANTED IN OCTOBER OF 1985. ON 9/5/96 A REC'D COMPLAINT FROM A PT REP STATED, "THE DEVICE HAD TO BE REMOVED IN JANUARY 1987 BECAUSE OF INFECTION. DUE TO SCAR TISSUE CREATED BY [THE PT'S] EXPERIENCE WITH THE FIRST DEVICE, HE HAS BEEN TOLD HE IS NOT A CANDIDATE TO HAVE A REPLACEMENT DEVICE PUT IN." THE PT REP HAS NOT PROVIDED A MEANS OR RELEASE TO CONTINUE WITH THIS INVESTIGATION. TO DATE, THIS COMPLAINT HAS NOT BEEN REPORTED BY A MED PROFESSIONAL OR CONFIRMED BY THE MFR. WITHOUT INFO FROM A MED PROFESSIONAL OR AN EXPLANTED DEVICE, QA IS PRECLUDED FROM COMMENTING ON THIS OCCURRENCE. SHOULD ADD'L INFO AND/OR THE EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE RE-OIPEND AND RE-EVALUATED, ACCORDING TO PROCEDURES.
REVISON SURGERY REVEALED POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA.
D6: CATALOG NUMBER: 6638-X-XXX. LOT CODE: UNK. THE DEVICE INFO ORIGINALLY PROVIDED WAS FOR THE REVISION COMPONENTS THAT WERE IMPLANTED. IT DID NOT REFLECT THE DEVICES THAT WERE REVISED. SUMMARY OF EVALUATION: THE TIBIAL AND PATELLAR COMPONENTS CAN NOT BE EVALUATED FOR THE REPORTED WEAR AS THEY HAVE NOT BEEN RETURNED TO HOWMEDICA. THE CATALOG NUMBERS AND LOT CODES HAVE NOT BEEN SUPPLIED SO THAT A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE COMPONENTS IS NOT POSSIBLE. ATTEMPTS TO OBTAIN THE DEVICE, CATALOG NUMBERS AND LOT CODE INFO HAVE BEEN UNSUCCESSFUL.
THE AUS DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS-BALLOON WOULD NOT INFLATE, AND REPLACED.
OXYGEN HOSE DISCONNECTED ON OXYGENATOR DURING CORONARY BYPASS SURGERY. HOSE RECONNECTED AND SURGERY PROCEEDED. IT WAS ESTIMATED THAT THE PT WAS WITHOUT OXYGEN FOR SEVERAL MINS.
IT WAS REPORTED THAT DURING USE ON A PT THE PUMP'S HELIUM LOSS AND HI PRESSURE ALARMS ACTIVATED. IT WAS DECIDED TO TRANSFER THE PT TO ANOTHER PUMP. THERE WERE NO PT COMPLICATIONS.
THE REP INVESTIGATED THIS INCIDENT. SHE CHECKED THE BALLOON CONNECTOR INTERFACE. A NEW INTERFACE BLOCK WAS ORDERED BY THE HOSP'S BIOMED DEPT. THE ARROW FIELD SVC REP RAN THE PUMP FOR 1 HOUR AND COULD NOT REPRODUCE THE ALARMS. THE PUMP PERFORMED NORMALLY.
THE DEVICE WAS REMOVED AS IT WAS "DEFECTIVE". IT WAS STATED THAT THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MFR'S PROSTHESIS.
EVALUATION AND DECONTAMINATION IS PENDING RECEIPTS OF THE DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVALUATION WILL BE FORWARDED UPON COMPLETION.
THIS TRANSFORMER DOES NOT HAVE A GROUND WIRE. THIS PROBLEM WAS FOUND UPON INCOMING INSPECTION.
SECTIONS A THROUGH F WERE COMPLETED BY THE MDR CONTACT. THE TRANSFORMER HAD A LOOSE WIRE INSIDE THE PLUG.
THE TOP BEARING BLOCK OF THE DEVICE HAS BECOME DETACHED FORM THE MAST ASSEMBLY DURING LIFTING OF THE PT FROM THE TOILET. THE PT WAS NOT HURT BUT RECEIVED A BLOW TO THE HEAD FROM THE FALLING YOKE ASSEMBLY.
FOREIGN REPORTER HAS ASSIGNED AN INVESTIGATOR TO THE INCIDENT, AND WILL FORWARD CLOSING OUT REPORT.
PT ALLEGES HER IMPLANTS ARE LEAKING. PT'S RADIOLOGY REPORT STATED "IMAGES OF RIGHT BREAST IMPLANT DEMONSTRATE A SMALL LOBULATION OF IMPLANT MEDIALLY AND SUPERIORLY. THERE APPEARES TO BE A FINE RADIOLUCENT LINE AT BASE OF THIS LOBULATION SUGGESTIVE OF SILICONE MATERIAL OUTSIDE OF CAPUSLE OF IMPLANT. ON LEFT SIDE, THERE IS A LARGER LOBULATION OF SILICONE. STATUS POST BILATERAL MAMMOPLASTIES WITH EVIDENCE OF HERNIATION OR MORE LIKELY, INTRACAPSULAR IMPLANT LEAK."
PT ALLEGES HER IMPLANTS ARE LEAKING. PT'S RADIOLOGY REPORT STATED "IMAGES OF RIGHT BREAST IMPLANT DEMONSTRATE A SMALL LOBULATION OF IMPLANT MEDIALLY AND SUPERIORLY. THERE APPEARS TO BE A FINE RADIOLUCENT LINE AT BASE OF THIS LOBULATION SUGGESTIVE OF SILICONE MATERIAL OUTSIDE OF CAPSULE OF IMPLANT. ON LEFT SIDE, THERE IS A LARGER LOBULATION OF SILICONE. STATUS POST BILATERAL MAMMOPLASTIES WITH EVIDENCE OF HERNIATION OR MORE LIEKELY, INTRACAPSULAR IMPLANT LEAK."
THE DEVICE WAS REMOVED DUE TO "LEAKAGE FROM THE PUMP". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 2-PIECE INFLATABLE PENILE PROSTHESIS.
ACCORDING TO AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS REMOVED ON 10/4/96 DUE TO "LEAKAGE OF PUMP." ADD'L INFO STATED THAT LEAKAGE WAS NOTED IN RESERVOIR. A RESIPUMP AND TWO CYLINDERS WERE RETURNED FOR EVAL. NO IMPLANT INFO WAS PROVIDED. REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING INCIDENT; HOWEVER, TO DATE REQUESTED INFO HAD NOT BEEN RECEIVED. WITHOUT REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON EVENTS SURROUNDING INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF RETURNED COMPONENTS REVEALED A SEPARATION/LEAKAGE SITE IN RESIPUMP BLADDER. THIS IS ONLY SITE OF LEAKAGE. EXAMINATION OF SURFACES OF SEPARATION REVEALED MARKINGS INDICATING CONTACT WITH SHARP INSTRUMENTATION. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MFG AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT OBSERVED DAMAGE OCCURRED SUBSEQUENT TO DEVICE PACKAGING BEING OPENED. BASED QA'S EXAMINATION AND LIMITED INFO PROVIDED, QA CONCLUDED THAT OBSERVED BLADDER SEPARATION WAS ONLY SITE THAT WOULD HAVE ALLOWED "LEAKAGE OF PUMP." HOWEVER, BECAUSE NO IMPLANT INFO WAS PROVIDED, QA IS PRECLUDED FROM DETERMINING SEQUENCE OF EVENT RESULTING IN OBSERVED SEPARATION.
POSTOPERATIVELY THE PT WAS PRESCRIBED A SUBCUTANEOUS MORPHINE INFUSION VIA A PCA PUMP. PT WAS INSTRUCTED AND INFUSION BEGAN AT 3:45 PM 10/29/96. PT'S WIFE REPORTED THAT THE PT WAS UNRESPONSIVE AT 8 AM ON 10/30/96. HE WAS TAKEN TO THE HOSP WHERE HE WAS SUBSEQUENTLY PRONOUNCED DEAD. WHEN THE PUMP WAS EXAMINED IN THE PT'S HOME SUBSEQUENT TO DEATH, IT WAS NOT PROGRAMMED IN ACCORDANCE WITH PRESCRIPTION. PRELIMINARY INDICATION OF CAUSE OF DEATH IS CARDIAC ARREST.
A PT WHO WAS 3 DAYS LATE FOR HER PERIOD HAD HER URINE TESTED USING THE HGC URINE ASSAY. THE RESULT WAS NEGATIVE. THE PT WAS TO HAVE A ENDOMETRIAL BIOPSY PERFORMED. THE LAB SUPV DECIDED TO DRAW A BLOOD SAMPLE FOR QUANTITIVE HCG TESTING (METHOD UNKNOWN). THE RESULT OF THE QUANTITATIVE TEST WAS 34MLU/ML. AN ULTRASOUND WAS THEN PERFORMED AND CONFIRMED THAT THE PT WAS PREGNANT. THE INITIAL URINE SAMPLE TESTED ON THE ASSAY WAS A FIRST MORNING VOID. AN OPENED KIT LOT/NUMBER 690604 WAS RETURNED FROM THE CUSTOMER FOR IN-HOUSE TESITNG. NO SAMPLE WAS RETURNED. NEGATIVE CONTROL, POSITIVE CONTROL AND POSITIVE CONTROL DILUTIONS WERE TESTED USING BOTH THE RETURNED KIT AND AN IN-HOUSE KIT OF THE SAME L/N. TESTING RESULTS WERE ACCEPTABLE.
THE SUBMISSION OF THIS MDR IS REQURIED OF DEVICE MFRS BY 21 CFR PART 803. NEITHER THE SUBMISSION OF INFO BY CO PURSUANT TO THIS RULE, NOR THE PUBLIC RELEASE OF SUCH INFO, CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CONNECTION BETWEEN THE PRODUCT AND ANY DEATH OR INJURY.
AUTOLIFT WOUND DOWN BY ITSELF, AS NURSE TRIED TO STOP HANDLE ROTATING SHE CUT HER THUMB.
FOREIGN REPORTER HAS ASSIGNED INVESTIGATOR AND WILL FORWARD CLOSING OUT REPORT ON INCIDENT TO THIS OFFICE.
PT ALLEGES SHE RECEIVED AN IMPLANT ON AN UNKNOWN DATE AND FROM AN UNKNOWN MFR. PT ALSO ALLEGES HER IMPLANT IS LEAKING AND THE DR RECOMMENDED REMOVAL.
RN ATTEMPTED TO INSERT NG TUBE AND PLACEMENT WS WRONG. NG TUBE PUNCTURED THE RIGHT LUNG. THE PT REQUIRED ADD'L HOSPITALIZATION.
THE DEVICE WAS REMOVED AS "THE PUMP EXTRUDED THROUGH THE SCROTUM". AS REPORTED TO CO, "NOTHING WAS WRONG WITH THE DEVICE, THE SURGEON PERFORMED A 1 1/2 HR SALVAGE PROCEDURE AND REMOVED AND REPLACED THE ENTIRE DEVICE.
THE DEVICE WAS RECEIVED FOR EVALUATION, HOWEVER, BECAUSE DEVICE EVALUATION WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE CONDITION NOTED IN VIVO THE RESULTS OF THE INITIAL REPORT REMAIN UNCHANGED.
REPORTER ALLEGES PT RECEIVED DEVICE ON 2/29/88. REPORTER ALSO ALLEGES PT HAD REMOVAL ON 7/5/96; HOWEVER, NO SPECIFICS WERE STATED EXCEPT REASON FOR EXPLANATION WAS STATED AS "LEAKING".
METHOD: 86B WEIGHT MEASUREMENTS. RESULTS: 100C SLIGHT AMBER COLOR; 100H LOSS OF SHELL INTEGRITY, ENVELOPE TEAR; 100I WEIGHT LESS THAN SPECIFIED; 100J FOREIGN MATERIAL IN GEL. CONCLUSION: 68 GEL NOT ALL RETURNED, FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED, CAUSE OF TEARS UNDETERMINED, COLOR WITHIN SPECIFICATIONS.
WHILE LOWERING A RESIDENT INTO THE BATH THE HOIST DROPPED. THE CARE ASSISTANT TRIED TO STOP THE CHAIR DROPING AND IN DOING SO HURT HER BACK. THE CARE ASSISTANT HAS SINCE BEEN OFF WORK. THE RESIDENT WAS UNINJURED.
THIS IS THE FOREIGN REPORTERS CLOSE OUT REPORT. INVESTIGATION: THE MACHINE OPERATED THROUGHOUT RANGE OF TRAVEL, NO FAULT WAS FOUND. OBSERVATIONS: THE INSIDES OF THE TUBE WERE MARKED, BUT WAS NOT MARKED ON THE OUTSIDE EDGES. CONCLUSIONS: ONLY POSSIBLE EXPLANTATION IS THA THE CHAIN JAMMED. CAUSE OF THIS INCIDENT IS USER ERROR AS THE HOIST SHOULD NOT HAVE BEEN FULLY UNWOUND. CORRECTIVE ACTIONS: A CO ENGINEER HAS CHECKED THE HOIST AND NO FAULTS WERE FOUND, THE CHAIN HAS BEEN REPLACED AS A PRECAUTION.
SHUNT IMPLANTED ON 10/17/96 FOR HYDROCEPHALUS. THE SHUNT WAS REMOVED ON 10/19/96 FOR MALFUNCTIONING.
PATIENT ALLEGES IN JUNE 1994 SHE NOTICED LUMPS IN HER LEFT BREAST AND A BIOPSY SHOWED SILICONE LUMPS; THEREFORE, THEY WERE REMOVED DURING THE BIOPSY. PATIENT THEN HAD MORE SILICONE LUMPS IN MAY 1996 AND ANOTHER BIOPSY WAS PERFORMED TO REMOVE LUMPS AGAIN. PATIENT ALSO ALLEGES HER SURGEON CONFIRMS A LEAKAGE DUE TO A HOLE.
A FACILITY REPORTED THAT 30 MINUTES INTO A TREATMENT, AIR INADVERTENTLY ENTERED THE EXTRA-CORPOREAL CIRCUIT THROUGH AN OPEN ARTERIAL MONITOR LINE OR SIDE LINE. THE FACILITY DOES NOT MONITOR ARTERIAL PRESSURE. AIR ENTERED THE DIALYZER AND EMPTIED THE VENOUS DRIP CHAMBER. NO ALARMS OCCURRED, THEREFORE THE BLOOD PUMP CONTINUED AT 600ML/MINUTE AND AIR TRAVELED PAST THE VENOUS LINE OCCLUDING CLAMP. THE NURSE NOTICED THE AIR, STOPPED THE BLOOD PUMP AND CLAMPED THE BLOODLINES. NO PT INJURY RESULTED. THE NURSE STATES THE MACHINE HAD PASSED THE PRETREATMENT TESTING PRIOR TO THE INITIATION OF THE TREATMENT. THE MACHINE WAS REMOVED FROM THE TREATMENT AREA FOR INVESTIGATION BY THE FACILITY MACHINE TECH. THE MACHINE TECH RETESTED THE MACHINE AND FOUND THE MACHINE TO BE OPERATING PROPERLY. HE REPLACED THE LEVEL DETECTOR EVEN THOUGH HE HAD FOUND NOTHING WRONG WITH IT. HE AGAIN VERIFIED THE MACHINE WAS OPERATING PROPERLY AND RETURNED THE MACHINE TO THE TREATMENT AREA. THE MACHNE HAS BEEN USED FOR TREATMENT SINCE, WITHOUT ANY PROBLEMS.
H3. MACHINE INSPECTED BY THE FACILITY TECH. BLOCK F. COMPLETED BY THE MFR.
EVAL SUMMARY: FINAL ANALYSIS REVEALED NO ROTATION OF THE LEAD SCREW DUE TO LOOSE PUSH PAWL SPRING. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. THIS REPORT MAY BE REQUIRED BY MEDICAL DEVICE REPORTING REGULATIONS CONTAINED IN 21 CFR SECTION 803. THESE REGULATIONS ARE VAGUE IN A NUMBER OF RESPECTS AND SUBJECT TO DIFFERENT INTERPRETATIONS, MOREOVER, THE REGULATIONS REQUIRE CO TO MAKE A DECISION ON REPORTING BEFORE HAVING COMPLETE INFO, INCLUDING OUR OWN ANALYSIS OF RETURNED PRODUCT.
CAPS NOTED TO BE OFF OF ELASTOMERIC PUMP (2) WHEN PLASTIC PACKAGE REMOVED. POSSIBLE CONTAMINATION OF STERILE PRODUCTS.
IT WAS REPORTED A FILTER DID NOT FULLY OPEN AFTER DEPLOYMENT VIA THE JUGULAR APPROACH. A SECOND FILTER WAS SUCCESSFULLY PLACED WITH NO PT COMPLICATIONS. THIS DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. FOLLOW UP INDICATED FREQUENT AND/OR CONTINUOUS FLUSHING WAS NOT PERFORMED PRIOR TO DEPLOYMENT AND MAY HAVE CONTRIBUTED TO THIS EVENT. THE DR STATED THE SYSTEM WAS FLUSHED ONCE DURING THE PROCEDURE. CO DIRECTIONS FOR USE STATE: "THE INTRODUCER CATHETER MUST BE FLUSHED THROUGH THE FLUSH PORT BY FREQUENT INJECTION OR CONTINUOUS INFUSION OF STERILE HEPARINIZED SALINE DURING THE IMPLANT PROCEURE. INSUFFICIENT FLUSHING CAN ALLOW THROMBUS FORMATION INSIDE THE VENA CAVA FILTER WHICH CAN BIND THE LEGS AND PREVENT COMPLETE OPENING UPON RELEASE. DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER. IN MOST CASES, A 2ND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE."
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REORT TO THE FDA.
SENSOR QUIT WORKING AND WAS TO BE EXPLANTED ON 10/04/96.
EXAMINATION CONFIRMED DEVICE TO BE NON-FUNCTIONAL UPON CO RECEIPT. ELECTRICAL ANALYSIS CONFIRMED THAT ONE OR MORE WIRES WERE BROKEN. MICROSCOPIC ANALYSIS REVEALED A BROKEN SEGMENT WHICH WAS MOST LIKELY THE RESULT OF AN EXCESSIVE TWIST OR PULL FORCE EXERTED ON THE CONNECTOR BODY AND/OR NYLON TUBING BY THE HANDLER OR BY THE PT. NOTE 1: PT CODE NOT SPECIFIED AND EVENT CAUSE USE OF ANOTHER THERAPEUTIC DEVICE. NOTE 2: THE INFO IN SECTION F IS BEING SUPPLIED BY THE MFR AND NOT THE USER FACILITY. NO MEDWATCH FORM HAS BEEN REC'D FROM THE USER FACILITY.
THE CHAIR UNIT IS DIFFICULT TO SLIDE OFF TCS. THIS HAS CAUSED A CARER TO DAMAGE HER BACK TRYING TO REMOVE CHAIR AND SHE IS OFF WORK AS A RESULT OF HER INJURIES.
FOREIGN REPORTER HAS ASSIGNED AN INVESTIGATOR TO THE INCIDENT AND WILL FORWARD CLOSING OUT REPORT.
THE PUMP WON'T DELIVER THE PROPER AMOUNT AND WON'T ACCEPT A 20CC SYRINGE. THERE WAS NO PT INJURY
THIS M.D.R. IS BEING FILED IN ORDER TO COMPLY WITH 21 CFR PART 803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT THE DEVICE ACTUALLY MALFUNCTIONED OR CAUSED ANY INJURY. H6. THE UNIT COULD NOT BE FLOW TESTED DUE TO AN INVALID SIZE ALERT. THE SIZE WAS FOUND TO BE OUT OF CALIBRATION DUE TO IMPROPER FIELD SERVICE. THE HISTORY WAS DOWNLOADED AND NO RECORDS WITH THE PARAMETERS STATED BY THE SOURCE COULD BE FOUND.
INVESTIGATION CONDUCTED AND DR. CITES INFECTION AS CAUSE FOR FAILURE.  PATIENT SMOKES AND CONSUMES ALCOHOL. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. THIS FILE IS CLOSED.
AS THE RESIDENT WAS BEING RAISED OUT OF THE BATH THE HOIST STARTED TO WIND DOWN, THE HANDLE HIT THE RESIDENT ON THE BACK OF THE HEAD CAUSING SOME BRUISING.
FOREIGN REPORTER HAS ASSIGNED AN INVESTIGATOR TO INCIDENT AND WILL FORWARD A CLOSING OUT REPORT.
HEAD OF DEVICE SEPARATED FROM SHAFT. SECOND WAND DID'T WORK OUT OF BOX.
VISUAL: PIN CONNECTION HAS BLACK CARBON IN CENTER (RETURN PIN AREA). ALSO CAP NOT ATTACHED TO RETURN. BLACK CHARRING ON POLYMIDE EXPOSED AT CAP/RETURN INTERFACE. REMOVED HANDLE TO SEE IF THERE WERE ANY SHORTS IN THE RETURN AREA-NONE FOUND. REQUESTED CABLE AND CONTROLLER TO BE RETURNED FOR ADDITIONAL ANALYSIS. 10/18/96:PER A/CHENG, THIS FAILURE COULD BE DUPLICATED BY PUTTING SALINE INSIDE THE HANDLE AND POWERING THE WAND. THE CAP DETACHED ON DEVICE #2 PROBABLY BECAUSE THE DEVICE WAS FOR SOME REASON SUSCEPTABLE AT THAT JOINT (POSSIBLE EPOXY BREACH).
EXPLANATION FOR CODE 68 (OTHER) USED IN SECTION H6: SLIGHT DAMAGED/WEAR (CAUSED BY USAGE) WAS OBSERVED, LOCATED AT THE PROXIMAL INNER DIAMETER EDGE OF THE OUTER CANNULA. THERE WERE SEVERAL COMPONENTS THAT ARE USED WITH THE TRACH TUBE. IT IS UNKNOWN AS TO THE EXACT CAUSE OF THE WEAR, OR WHICH COMPONENT THAT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL PRODUCT WAS ACCEPTABLE UPON RELEASE.
INCREASED DIFFICULTY AMBULATING. PAIN. LINER OF ACETABULAR CUP WORN. ACETABULAR CUP LOOSE. REPLACED.
THE LEAD WAS EXPLANTED DUE TO A REPORT SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. POST EXPLANT THE PHYSICIAN NOTED THE LEAD NOT FRACTURED.
A BALLOON RUPTURED ON THE FIRST INFLATION DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATION. THIS DEVICE HAS NOT BEEN RETURNED FOR EVAL. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKEAGE IS AN ANTICIPATE EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZAITON OR USE IN A CALCIFIED LESION. FOLLOW UP REVEALED THIS BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE. IT WAS ALSO INDICATED THE LESION WAS CALCIFIED. THEREFORE, CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE PRODUCT, CO CANNOT DETERMINE THE EXACT CAUSE OF THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "DO NOT EXCEED THE NORMAL PRESSURE PRINTED ON THE PRODUCT LABEL. NEVER MANIPULATE THE CATHETER WITH THE BALLOON INFLATED. THE INTEGRITY OF ALL BALLOON CATHETERS MAY BE COMPROMISED BY SHAPE OBJECTS OR SURFACES. NOT RECOMMENDED FOR USE IN CALCIFIED LESIONS."
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON IFNO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
OTHER DEVICES USED: CATALOG #00-9026-033-00 HARRIS FEMORAL HEAD LOT #63664500. EVALUATION CODES FOR SECTION H6: 100 THE SHELL HAS 3 TABS MISSING. THE LINER HAS EXTENSIVE DAMAGE MAKING ACCURATE DIMENSIONS IMPOSSIBLE. THIS DAMAGE INCLUDES WHAT APPEARS TO BE IMPINGEMENT. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "N" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "N" IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNK OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
DEVICES REMOVED AND REPLACED DUE TO LOOSE ACETABULAR CUP AND WORN LINER.
DEVICES REMOVED AND REPLACED DUE TO LOOSE ACETABUALR CUP AND WORN LINER.
THE ALTERNATING PRESSURE MATTRESS WENT FLAT. RN CALLED THE MFR TO REPORT THE MATTRESS BEING FLAT AND THE PT'S DECUBITUS ULCER WORSENING. INSTRUCTED TO FAX TO THEM A REQUEST FOR ANOTHER MATTRESS AND THAT ANOTHER MATTRESS WOULD BE MAILED TO THE PT'S HOME. PT'S SPOUSE TOLD THE NURSE THAT IT TAKES (11) ELEVEN DAYS TO RECEIVE ANYTHING AND THAT THE CO SENDS NO ONE OUT TO SVC EQUIPMENT.
REPORT RECEIVED FROM EUROPEAN OPERATIONS INDICATED THAT, DURING CLINICAL USE, BALLOON LEAKAGE WAS NOTED. THERE WAS NO REPORT OF PT INJURY OR COMPLICATIONS. THE PRODUCT IS TO BE RETURNED TO THE EUROPEAN FIRM SITE FOR EVALUATION AND TESTING, BUT HAS NOT YET BEEN RECEIVED. PLEASE NOTE DATE OF 11/08/96 FOR SUBMISSION OF SUCH INFORMATION PENDING THE PRODUCT RETURN AND COMPLETION OF THE ANALYSIS.
ON 8/28/96 PT WAS ADMITTED TO HOSPITAL WITH THROMBOCYTOPENIA AND JAUNDICE. CARDIO ECHO REVEALED A LARGE VEGETATION ON THE AORTIC VALVE. ALLOGRAFT #6010024 (IMPLANTED 1/2/96) WAS EXPLANTED WITH A NEW ALLOGRAFT. PT IS IN SATISFACTORY CONDITION.
MFR DID NOT RECEIVE THE MANDATORY 3500A FORM. MFR COMPLETED SECTIONS A-F. THIS REPORT IS CONSIDERED CLOSED, UNLESS DIRECTED OTHERWISE.
INFO SUPPLIED IN SEC F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT OF THE FDA.
FILTER DID NOT OPEN COMPLETELY FOLLOWING DEPLOYMENT VIA FEMORAL APPROACH. MANIPULATION OF THE FILTER WITH THE INTRODUCER SHEATH RESULTED IN A COMPLETE OPENING. THIS DEVICE REMAINS IMPLANTED THEREFORE NO FAILURE ANALYSIS WILL BE AVAILABLE. FOLLOW UP INDICATED FREQUENT AND/OR CONTINUOUS FLUSHING WAS NOT PERFORMED PRIOR TO DEPLOYMENT AND MAY NOT HAVE CONTRIBUTED TO THIS EVENT. CO'S DIRECTIONS FOR USE STATE: " THE INTRODUCER CATHETER MUST BE FLUSHED THROUGH THE FLUSH PORT BY FREQUENT INJECTION OR CONTINUOUS INFUSION OF STERILE HEPARINIZED SALINE DURING THE IMPLANT PROCEDURE...INSUFFICIENT FLUSHING CAN ALLOW THROMBUS FORMATION INSIDE THE FILTER WHICH CAN BIND THE LEGS AND PREVENT COMPLETE OPENING UPON RELEASE...CONFIRM LOCATION OF THE CARRIER CAPSULE BY INJECTING CONTRAST THROUGH THE HANDLE OF THE INTRODUCER CATHETER... DO NO ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER... IN MOST CASES, A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE."
ON 8/12/96 RN WAS WORKING A 12 HR SHIFT USING LATEX GLOVES. AT 7:00 PM SHE HAD A NECTARINE AND WITHIN 20 MINS HAD DIFFICULTY BREATHING. 911 WAS CALLED AND SHE WAS FOUND BLUE AND UNRESPONSIVE. SHE WAS INTUBATED AND PLACED ON A VENTILATOR AT THE HOSP AND STAYED FOR 4 DAYS. SHE WAS DIAGNOSED WITH ANAPHYLACTIC REACTION AND RESPIRATORY FAILURE. PT WAS REQUIRED TO CARRY AN "EPI-PEN" AND TO TAKE BENADRYL. PT IS NO LONGER WORKING AS AN RN AND IS HAVING TROUBLE FINDING APPROPRIATE WORK DUE TO LATEX ALLERGY.
PT REQUIRED EXPLANT OF PULMONARY VALVE AND CONDUIT HOMOGRAFT DUE TO PULMONARY VALVE STENOSIS AND INSUFFICIENCY.
A FACILITY REPORTED THAT A PT HAD DEVELOPED HEMOLYSIS DURING DIALYSIS. AFTER AN HOUR AND A HALF THE PT BEGAN COMPLAINING OF ACHING IN THE CHEST AND CHILLS. BLOOD CULTURES WERE DRAWN AND THE PT GIVEN ANTIBIOTICS. THE FACILITY STATES THERE WAS NO CHANGE IN THE BLOOD COLOR, NO EVIDENCE OF EXCESSIVE NEGATIVE PRESSUE , NO KINKS FOUND IN THE ARTERIAL BLOOD LINE. NO HEMATOCRIT WAS DRAWN. THE TREATMENT WAS COMPLETED AND LAB WAS DRAWN FOR LDH. THE RESULTS WERE HIGH, INDICATING HEMOLYSIS. THE PT WAS ADMITTED TO THE HOSP FOR OBSERVATION OVER THE WEEKEND. THE PT DID NOT RECEIVE ANY MEDICAL INTERVENTION IN THE HOSP. THE PT RETURNED TO THE FACILITY 10/21 AND RECEIVED DIALYSIS WITHOUT COMPLICATIONS. THE MACHINE HAD BEEN REMOVED FROM THE TREATMENT AREA FOR INSPECTION BY THE MFR. THE MACHINE WAS FOUND TO BE OPERATING PROPERLY. A QUESTION WAS RAISED ABOUT THE TECHNIQUE BEING USED TO PLACE THE BLOOD PUMP SEGMENT INTO THE BLOOD PUMP HOUSING. THE TECHNIQUE DEMONSTRATED BY THE FACILITY  MACHINE TECH WAS NOT THE DEVICE LABELING RECOMMENDED TECHNIQUE. INCORRECT INSERTION OF THE BLOOD PUMP SEGMENT INTO THE BLOOD PUMP HOUSING COULD CONTRIBUTE TO THE BLOOD PUMP SEGMENT KINKING UNDER CERTAIN CONDITIONS, WHICH COULD RESULT IN HEMOLYSIS.
BLOCK F. COMPLETED BY THE MFR. F10. INITIALLY THE PHYSICIAN SUSPECTED A PYROGENIC REACTION, WHICH IS ADDRESSED IN THE DEVICE LABELING.
RECIVED REPORT OF A FAILURE. NO FURTHER INFO AT THIS TIME.
PT REQUIRED EXPLANT OF AORTIC VALVE ALLOGRAFT DUE TO STENOSIS AND CALCIFICATIONS.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUANTITY AND QUALITY, AND POSSIBLE POST-SURGICAL LOADING OF THE IMPLANT AS CAUSES FOR FAILURE. NOT USING AN HA COATED IMPLANT MAY ALSO BE AN ISSUE. THIS FILE IS CLOSED.
PT REQUIRED EXPLANT OF PULMONARY ALLOGRAFT VALVE DUE TO PULMONARY STENOSIS.
MFRS DID NOT RECEIVE THE MANDATORY 3500S FORM. MFR COMPLETED SECTIONS A-F. THIS REPORT IS CONSIDERED CLOSED, UNLESS DIRECTED OTHERWISE.
SECTION 10 A AND B. AS A RESULT OF REGULATION CHANGES EFFECTIVE 7/31/96, THIS SECTION NO LONGER APPLIES. *A, B.6, B.7, H.4, AND H.8 UNKNOWN-ATTEMPTED TO GET MORE DETAILS 8/1/96. H3. LAB EVAL CONFIRMED THE SET TO LEAK FROM A SPLIT IN THE CASSETTE FILM AT THE INLET VALVE. THE LEAKAGE OCCURS AFTER CONTINUOUS USE IN THE PUMP; HOWEVER, THE PROBLEM IS NOT WITH THE PUNP, BUT THE SET. THE CASSETTE'S SILICONE RUBBER INLET TUBING HAS BEEN OBSERVED TO MOVE WHILE IN USE. THIS HAS BEEN FOUND TO OCCUR ONLY ON THE CASSETTE AUTOMATED ASSEMBLY PROCESS. IMMEDIATE ACTION HAS BEEN TAKEN TO RESTRICT THE MFG PROCESS TO THE MANUAL PROCESS ONLY. IN ADDITION, IMPROVEMENTS TO THE MATEIRAL AND AUTOMATED PROCESS HAVE BEEN DEVELOPED. A PRODUCT ADVISORY IS BEING FORWARDED TO CUSTOMERS 10/96.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUANTITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. OTHER FAILED IMPLANTS-(FROM BOX D6) MODEL/CATALOG#, LOT NUMBER.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY CO. VISUAL EXAMINATION: BALLOON EXHIBITED A 1.8 CM LONG, AXIALLY DIRECTED TEAR, O.4 CM PROXIMAL TO THE DISTAL TIP. FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING THE TEAR EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
PT REQUIRED EXPLANT OF AORTIC VALVE DUE TO CALCIFICATION AND CUSP DEGENERATION (WITH NOTED CALCIFICATION OF HOMOGRAFT VALVE LEAFLETS.
NO MEDWATCH REPORT WAS PROVIDED BY THE USER FACILITY, ALL INFO, WAS OBTAINED BY CO. VISUAL EXAMINATION: THE BALLOON EXHIBITED A 0.8CM LONG, AXIALLY DIRECTED TEAR, 1.6CM PROXIMAL TO THE DISTAL TIP. FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING THE TEAR EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUANTITY AS WELL AS POOR ORAL HYGIENE AS THE CAUSES FOR FAILURE. DR ALSO STATES PT IS A HEAVY SMOKER, CONSUMES ALCOHOL AND HAS EXPERIENCED EXCESSIVE TRAUMA. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES THE CAUSE FOR FAILURE DUE TO INFECTION. PT SMOKES. THIS FILE IS CLOSED. OTHER FAILED IMPLANTS-(FROM BOX D6) MODEL/CATALOG#, LOT NUMBER 2910TPS/2910TPS 951437.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF THRESHOLD INCREASE. FAILURE ANALYSIS IS PROVIDED.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES APPROX 35MM OF THE PROXIMAL END OF THE J STIFFENER WIRE IS PROTRUDING OUT OF THE INNER CONDUCTOR AND INNER POLYURETHANE INSULATION APPROX 84MM PROXIMAL OF ELECTRODE TIP. THE DISTAL END OF THE OUTER POLYURETHANE INSULATION WHICH SEPARATED FROM THE PROXIMAL OF ELECTRODE TIP UP AGAINST THE PROTRUDING J STIFFENER WIRE. THE J STIFFENER WIRE NEVER PROTRUDED THROUGH THE OUTER POLYURETHANE INSULATION. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE PROXIMAL END OF THE STIFFENER WIRE CONFIRMS TO THE DESIGN SPECIFICATION. X-RAY OF LEAD INDICATES NO J STIFFENER WIRE FRACTURES BUT DOES CONFIRM THE STRETCHED CONDITION OF THE INNER AND OUTER CONDUCTORS.
INVESTIGATION CONDUCTED. DR CITES NOT KNOWN CAUSE FOR FAILURE. PT IS 15 YEARS OLD. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES THAT THERE THE CAUSE FOR THE FAILURE IS UNEXPLAINABLE. THIS FILE IS CLOSED.
PREMILINARY EXAMINATION OF THE RETURNED SHEATH INTRODUCER HAS REVEALED THAT THE SHEATH IS OCCLUDED BY THE SOFT WASHER FROM THE VALVE ASSEMBLY.
H7:ERROR.NO REMEDIAL ACTION WAS INITIATED. INITIAL REPORT INCORRECTLY INDICATED THAT "NOTIFICATION" WAS GIVEN.
IT WAS REPORTED THAT AN OVERINFUSION OCCURRED WHILE UTILIZING THE INSTRUMENT. NO DETAILS OR INFO REGARDING THE INCIDENT WAS AVAILABLE OR PROVIDED BY THE USER/FACILITY.
THE PUMP WAS RETURNED FOR EVAL. VISUAL INSPECTION REVEALED THAT THE DISPLAY WAS "SCATTERED". THE PUMP WAS FOUND TO HAVE AN INCONSISTANCY IN RATE ACCURACY, AND THE INSTRUMENT'S JAW HEIGHT WAS OUT OF SPECIFICATION ON CHANNEL B AND C. IT IS SUSPECTED THAT THE DAMAGE TO THE INSTRUMENT RESULTED FROM IMPACT OF EITHER BEING DROPPED OR HIT. IMPACT DAMAGE CAN CAUSE MISALIGNMENT OF COMPONENT PARTS. IT SHOULD BE NOTED THAT THE ACCOUNT CONFIRMED THAT THE PUMP HAD EXPERIENCED IMPACT DAMAGE PRIOR TO BEING RETURNED. THE DISPLAY WAS REPLACED AND THE JAW HEIGHT WAS ADJUSTED. ALL POST-TESTING RESULTS WERE WITHIN MANUFACTURING SPECIFICATION. THE UNIT WAS ROUTED THROUGH CO'S SERVICE DEPARTMENT AND RETURNED TO THE CUSTOMER.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY & SITE QUESTIONABLE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
INVESTIGATON CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY & SITE QUESTIONABLE AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES THE CAUSE FOR FAILURE AS UNK. THIS FILE IS CLOSED.
THE SHEATH WAS PLACED IN RIGHT FEMORAL VEIN FOR A CADIAC CATHETERIZATION PROCEDURE. A CATHETER FROM ANOTHER MFR WAS PLACED THROUGH THE SHEATH, AND REPOSITIONING REQUIRED PULLING THE CATHETER BACK THROUGH THE SHEATH. DURING MANIPULATION THE SHEATH SHEARED AND A PORTION OF THE SHEATH REMAINED IN THE FEMORAL VEIN. THE DETACHED SEGMENT OF SHEATH LODGED IN THE LEFT PULMONARY ARTERY AND WAS RETRIEVED UNDER FLUOROSCOPY. PT WAS ADMITTED FOR OBSERVATION.
THE DEVICE WAS NOT RETURNED. RETENTION SAMPLES WERE VISUALLY OBSERVED AND NO ABNORMALITY WAS NOTED. THE DESCRIBED OCCURRENCE MAY BE CAUSED IF THE BALLOON CATHETER IS NOT FULLY DEFLATED PRIOR TO WITHDRAWAL THROUGH THE INTRODUCER SHEATH.
THE PT, A TYPE II DIABETIC WHO ADMINISTERS INSULIN, REPORTED HIGHER BLOOD GLUCOSE READINGS WITH CO'S DEVICE LOT 16143A. ON 9/14/96 THE PT OPENED THE FIRST BOTTLE FROM THE FIRST BOX AND OBTAINED BLOOD GLUCOSE READINGS IN THE 200 MG/DL RANGE FOR APPROX TWO WEEKS. HE THOUGHT THESE READINGS WERE HIGH BECAUSE HIS TYPICAL BLOOD GLUCOSE READINGS WITH TEST STRIPS (THE PREVIOUS WEEK) WERE IN THE 120 MG/DL RANGE. BECAUSE OF THE HIGHER READINGS, THE PT SET THE FIRST BOTTLE ASIDE AND OPENED THE SECOND BOTTLE FROM THE SAME BOX. HE AGAIN OBTAINED BLOOD GLUCOSE READINGS IN THE 200 MG/DL RANGE SO HE OPENED THE FIRST BOTTLE OF TEST STRIPS FROM A SECOND BOX OF CO TEST STRIP  (SAME LOT NUMBER). HE OBTAINED BLOOD GLUCOSE READINGS IN THE 200 MG/DL RANGE WITH THIS BOX AS WELL SO HE OPENED THE SECOND BOTTLE OF TEST STRIPS FROM THE SAME BOX AND, AGAIN, OBTAINED BLOOD GLUCOSE READINGS IN THE 200 MG/DL RANGE. YESTERDAY, THE PT PURCHASED A NEW BOX OF ANOTHER CO'S TEST STRIPS (LOT UNK) AND PERFORMED A SIDE BY SIDE BLOOD GLUCOSE COMPARISON WITH A TEST STRIP FROM THE FIRST BOTTLE FROM THE FIRST BOX OF CO'S DEVICE VERSUS THE OTHER STRIPS. HE OBTAINED RESULTS OF 181 AND 87 MG/DL RESPECTIVELY. HE THEN PERFORMED A NORMAL CONTROL SOLUTION TEST WITH ANOTHER TEST STRIP AND OBTAINED A RESULT OF 110 WHICH WAS WITHIN THE NORMAL CONTROL SOLUTION RANGE. WHEN THE CONTACT SPOKE WITH THE REP, HIS TEST STRIPS WERE NOT AVAILABLE SO HE COULD NOT PROVIDE A NORMAL CONTROL SOLUTION RANGE OR LOT NUMBER. WITH THE REP, THE PT PERFORMED NORMAL CONTROL SOLUTION TESTS WITH THREE BOTTLES OF CO'S TEST STRIPS. THE PT DID NOT PERFORM A NORMAL CONTROL SOLUTION TEST WITH THE FIRST BOTTLE FROM THE FIRST BOX OF CO'S TEST STRIPS BECAUSE HE HAD USED ALL THE TEST STRIPS. WITH THE 2ND BOTTLE FROM THE 1ST BOX, THE PT OBTAINED A NORMAL CONTROL SOLUTION TEST RESULT OF 164 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 110-164 MG/DL (SOLUTION LOT VJ 135, EXP 10/97). WITH THE FIRST BOTTLE FROMT HE SECOND BOX, THE PT OBTAINED A CONTROL SOLUTION RESULT OF 166 MG/DL SAME NORMAL CONTROL SOLUTION RANGE. WITH THE 2ND BOTTLE FROMT HE 2ND BOX, THE PT OBTAINED A CONTROL SOLUTION RESULT OF 171 MG/DL (SAME NORMAL CONTROL SOLUTION RANGE). ALSO WITH THE REP, THE PT PERFORMED A CHECK STRIP TEST AND OBTAINED A RESULT OF 78 VERSUS A CHECK STRIP RANGE OF 73-98. THE PT COULD NOT PERFORM SIDE BY SIDE BLOOD GLUCOSE COMPARISONS WITH CO'S TEST STRIP. BECAUSE AS MENTIONED PREVIOUSLY, THE OTHER TEST STRIPS WERE NOT AVAILABLE. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN CO'S TESTS WERE PERFORMED. THE DESICCANT IS IN THE THREE BOTTLES OF THE CO'S TEST STRIP ON WHICH THE PT PERFORMED A NORMAL CONTROL SOLUTION TEST WITH THE REP. THE PT STATED HE HAD REMOVED THE DESICCANT FROMT EH FIRST BOTTLE FROMT HE FIRST BOX WHEN HE HAD ONLY THREE TEST STRIPS REMAINING. THE PT SHOOK THE CONTROL SOLUTION BEFORE HE APPLIED THE SAMPLE TO THE TEST PAD. THE CONTROL SOLUTION WAS OPENED TWO WEEKS AGO. THE PT STORES HIS TEST STRIPS IN HIS BEDROOM.
ERROR GRID ANALYSIS BASED ON CUSTOMER REPORTED RESULT INDICATES THAT CUSTOMER'S TEST STRIPS MAY PRODUCE RESULTS WHICH FALL IN ZONE B, AND DO NOT REPRESENT A REASONABLE RISK OF SERIOUS INJURY. THE RETENTION SAMPLE TEST RESULTS FOR CO'S DEVICE MEET THE SPECS FOR BLOOD GLUCOSE ACCURACY AND PRECISION AND THE NORMAL CONTROL READINGS WERE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE EVAL OF RETENTION SAMPLES, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. CO REQUESTED THAT THE PRODUCT BE RETURNED FOR EVAL ON 10/09/96. AS OF 11/7/96, RETURNED PRODUCT HAS NOT BEEN REC'D. CO WILL FORWARD A FOLLOW-UP TO THIS REPORT UPON RECEIPT OF RETURNED TEST STRIPS AND THEIR EVAL. TIME FRAME IS UNK. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? YES. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? YES. IS EVENT OCCURING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
THE HOSP MADE A CALL TO THE MFR REP TO ASK WHAT THE RECOMMENDED FLOW RATES WERE FOR CT. THEY BELIEVED THAT THE INCREASED FLOW RATES THAT THEY WERE USING MAY BE CAUSE FOR THE FOUR EXRAVASATIONS THAT OCCURRED OVER A 2 MONTH PERIOD.
HOSP PERSONNEL CALLED FOR GUIDANCE DOCUMENTS REGARDING RECOMMENDED FLOW RATES DURING CT SCANS. AT THIS TIME, THE MFR'S REP LEARNED THAT 4 EXTRVASATIONS OCCURRED OVER A 2 MONTH PERIOD. SINCE THE INJECTOR DID NOT MALFUNCTION AND HOSP BIO-MED HAD COMPLETED SEVERAL UNIT CHECK-OUTS, MFR ANALYSIS IS NOT NEEDED. CAUSE FOR EXTRAVASATION IS SUSPECTED TO BE CAUSED BY HIGHER INJECTION FLOW RATES AS SELECTED BY THE RADIOLOGISTS. GUIDANCE DOCUMENTS WERE SUPPLIED TO THE HOSP TO MINIMIZE EXTRAVASATION.
INVESTIGATON CONDUCTED. DR CITES THE CAUSE FOR THE FAILURE AS UNK. THIS FILE IS CLOSED.
DURING THE PROCEDURE THE SHAFT OF THIS DEVICE REPORTEDLY BROKE INTO TWO PIECES. THE INCIDENT OCCCURRED AT THE END OF THE PROCEDURE. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
INVESTIGATION CONDUCTED. DR CITES PORT SURGICAL, PRE-EXPOSURE, LOADING OF THE IMPLANT. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES AGE (82YRS) AS POSSIBLE CAUSE FOR FAILURE. AT THE TIME OF SURGERY THERE WAS LIMITED VERTICAL SPACE ABOVE THE CANAL AND LIMITED ACCESS DUE TO LIMITED OPENING AND IMPLANT WAS LOOSE AT TIME OF SURGERY. THIS FILED IS CLOSED.
INVESTIGATION CONDUCTED. DR DOES NOT CITE A CAUSE FOR FAILURE OTHER THAN THE IMPLANT WAS LOOASE IN THE OSTEOTOMY. THIS FILE IS CLOSED.
IT HAS BEEN REPORTED TO CO THAT DURING THE PROCEDURE THE GASKET OF THIS DEVICE DISLODGED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
ON 6/15/96 PT UNDERWENT REPAIR FOR TETROLOGY OF FALLOT WITH ABSENT PULMONARY HEART SYNDROME WITH A CRYOPRESERVED PULMONARY HEART VALVE IN A RVOT PROCEDURE. AT 3 MONTHS POST-OPERATIVE PT PRESENTED PULMONARY INSUFFICIENCY AND MARKED DILATION OF THE PROXIMAL PA BRANCHES. ALLOGRAFT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHESIS. PT IS IN SATISFACTORY CONDITION.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUANTITIY AS THE CAUSE FOR FAILURE. THIS FILE IS CLOSED.
THE BALLOON BURST AT 15 ATM WITHIN THE STENT. THE PT HAS HEPATITIS AND THE PRODUCT WILL NOT BE RETURNED.
NO MEDWATCH REPORT PROVIDED BY THE USER FACILITY, ALL INFO OBTAINED BY THE CO. THE PT HAS HEPATITIS AND THE PRODUCT WILL NOT BE RETURNED. THIS FILE IS CONSIDERED CLOSED.
DURING AN SFA PROCEDURE, THE CATHETER BALLOON RUPTURED ON THE SECOND INFLATION. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS BEING REPORTED.
PT DEATH DUE TO A RUPTURED THORACIC AORTIC ANEURYSM. NO AUTOPSY RESULTS AVAILABLE AT THIS TIME.
ADDITIONAL INFO: AUTOPSY REPORT REVEALED THAT INCIDENT WAS NOT RELATED (DIRECTLY OR INDIRECTLY) TO DEVICE. EVALUATION CODES CHANGED TO REFLECT NEW INFO. THIS REPORT IS CONSIDERED CLOSED, UNLESS DIRECTED OTHERWISE.
CAP CAME OFF ARTERIAL LINE CATHETER RESULTING IN A LARGE LOSS OF BLOOD. PRESSURE ALARMS ALERTED STAFF OF PROBLEM. IT IS SUSPECTED THE PT UNKNOWINGLY REMOVED THE CAP. A CODE WAS CALLED, PT SURVIVED. ARTERIAL LINE NOT AVAILABLE FOR INVESTIGATION.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT OF THE IMPLANT AS THE CAUSE FOR FAILURE. THIS FILE IS CLOSED.
THE SHAFT OF THIS DEVICE KINKED DURING THE PROCEDURE. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
FACILITY IS FINDING INCREASING NUMBER OF INCOMPLETE, SPOTTY OR PATCHY ANESTHETICS. THIS HAS OCCURRED WITH DIFFERENT PRACTIONERS IN HOSP. RPTR IS ATTEMPTING TO CALL CO'S PRODUCT ASSURANCE TO SEE IF THERE HAVE BEEN ANY OTHER PROBLEMS FROM OTHER INSTITUTIONS.
DIFFICULTIES DURING INITIAL ADVANCEMENT OF THE FILTER SYSTEM FOR A FEMORAL FILTER PLACEMENT WERE ENCOUNTERED. MANIPULATION RESULTED IN INADVERTANT PREMATURE DEPLOYMENT OF THIS FILTER. INCOMPLETE FILTER OPENING WAS REPORTED. ANOTHER FILTER WAS NOT PLACED AT THAT TIME. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAIILABLE FOR EVAL. IT WAS INDICATED A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO FILTER PLACEMENT AND DIFFICULTIES DURING INITIAL ADVANCEMENT OF THE INTRODUCER SHEATH AND CARRIER SYSTEM WERE ENCOUNTERED. CONTINUAL MANIPULATION MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "AN INFERIOR VENA CAVOGRAM MUST BE PERFORMED PRIOR TO VENA CAVA FILTER INSERTION. THIS PROCEDURE DETERMINES CAVAL PATENCY AND DIAMETER AND IS USED TO EVALUATE THE INFERIOR VENA CAVA FOR THE PRESENCE OF THROMBUS AND CONGENITAL ANOMALIES. IF DIFFICULTY IS ENCOUNTEED DURING INTRODUCER CATHETER ADVANCEMENT THROUGH THE SHEATH, STOP. DO NOT FORCE THE INTRODUCER CATHETER FORWARD. SLIGHTLY WITHDRAW THE SHEATH AND INTRODUCER CATHETER AS A UNIT (ABOUT 2-3CM). THEN ROTATE THE SHEATH AS YOU ADVANCE THE INTRODUCER CATHETER. IF THIS FAILS, REMOVE THE INTRODUCER CATHETER. DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER. IN MOST CASES, A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE."
FURTHER FOLLOW UP RECEIVED AFTER THE INITIAL MEDWATCH REPORT WAS FILED INDICATED A SECOND FILTER WAS SUCCESSFULLY PLACED VIA THE JUGULAR APPROACH BETWEEN 24 TO 48 HOURS AFTER INITIAL FILTER PLACEMENT WITHOUT PATIENT COMPLICATIONS.
CATH INSERTED 3/4/94. ON 10/4/96, ATTEMPT TO ACCESS CATH. PT COMPLAINED OF DISCOMFORT WITH SWELLING AT SITE. CHEST X-RAY CONFIRMED A FRACTURE THROUGH THE CATHETER WITH DISTAL END MIGRATION.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE INNER BODY. THE BALLOON EXHIBITED A 0.9 CM LONG, AXIALLY-DIRECTED TEAR, 1.2CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAMINATION: FURTHER EVAL USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING AND ADJACENT TO THE TEAR EDGES. ALTHOUGH THE EXACT CAUSE FRO THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
INVESTIGATION CONDUCTED. DR CITES THE CAUSE FOR FAILURE AS UNDETERMINED. PT CONSUMES ALCOHOL OCCASIONALLY. THIS FILE IS CLOSED. OTHER FAILED IMPLANTS-(FROM BOX D6) MODEL/CATALOG# LOT NUMBER 3912HL/3912HL, 954866.
INVESTIGATION CONDUCTED. DR CITES POSSIBLE INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
SPIKING PORTR IS WEAK. WHEN RN INSERTED THE IV TUBING SPIKE, THE PORT WEAKENED AND SPIKE WENT THROUGH THE SIDE OF PORT.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR THE FAILURE. THIS FILE IS CLOSED.
THE ER320 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE DID NOT FIRE CORRECTLY, MISFIRED. 10/16/96, ANOTHER ER320 WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: INFO UNAVAILABLE. D5; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 10/17/96, 1055 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/18/96 NNCL SENT. 10/23/96 1600, SURGICAL ASST RESPONDED TO THE NNCL. SHE STATED DR USUALLY PRECOCKS THE CLIP APPLIER WHEN PLACING THE CLIP AROUND THE VESSEL. THE CLIPS FELL OUT OF THE APPLIER BEFORE HE COULD APPLY THEM TO THE VESSEL.
INVESTIGATION CONDUCTED. DR CITES THE CAUSE FOR FALURE AS UNEXPLAINABLE. THIS FILE IS CLOSED.
THE DISTAL TIP OF THE .018 GUIDEWIRE DETACHED IN THE KIDNEY DURING A NEPHROSTOMY TUBE PLACEMENT. RETRIEVAL ATTEMPTS WITH A SNARE WERE UNSUCCESSFUL. NO FURTHER RETRIEVAL ATTEMPT WERE MADE AND THE PT HAS SINCE PASSED THE GUIDEWIRE SEGMENT WITHOUT INCIDENT. THE PT WAS UNAWARE OF THIS EVENT AND SUFFERED NO SEQUELAE. THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL REVEALED THAT ALTHOUGH NO IDICATIONS OF USE WERE DETECTED, THE WIRE WAS MISSING ITS PLATINUM COATED FLOPPY TIP. THE TIP WAS NOT RETURNED FOR EVAL. IT APPEARS THAT THE BALL WELD THAT CONNECTS THE COILED PLATINUM WIRE TO THE CORE WIRE HAD BROKEN. AS FOLLOW UP COULD NOT DETERMINE IF ANY RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE, CO BELIEVES THAT USER TECHNIQUE AND/OR PT ANATOMY MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, WITHOUT FURTHER DETAILS OR EVALUATING THE ENTIRE DEVICE, CO CANNOT DETERMINE THE CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "WITHDRAWAL OF THE .018/.038 WIRE SHOULD BE SMOOTH AND WITHOUT RESISTANCE. IF RESISTANCE IS FELT, CAREFULLY REMOVE WIRES AND SYSTEM AS UNIT".
INVESTIGATION CONDUCTED. DR CITES THAT THE CAUSE FOR FAILURE IS UNKNOWN. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES INFECTION AND POSSIBLE SURGICAL TRAUMA AS CAUSE FOR FAILURE. THIS FILE IS CLOSED. OTHER FAILED IMPLANTS-(FROM BOX D6) MODEL/CATALOG #, LOT NUMBER 2912HL/2912HL, UNK, 2912HL/2912HL, UNK.
THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION; TRACES OF DRIED BLOOD RESIDUE WERE NOTED WITHIN THE BALLOON. THE BALLOON EXHIBITED A 1.2 CM AXIALLY-DIRECTED TEAR, .6 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC EXAMINATION: FURTHER EVALUATION USING SCANNING ELECTRON MICROSCOPY (SEM) REVEALED EVIDENCE OF EXTERNAL SURFACE ABRASIONS INTERSECTING AND ADJACENT TO THE TEAR EDGES. ALTHOUGH THE EXACT CAUSE FOR THE BALLOON DAMAGE COULD NOT BE DETERMINED, IT APPEARS THAT THE BALLOON WAS EXPOSED TO AN UNIDENTIFIED SOURCE OF ABRASION.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON AN UNKNOWN DATE THE ER320 CLIPS BEGAN TO SCISSOR AND/OR DID NOT CLOSE COMPLETELY WITH THE 2ND CLIP AND THE CLIPS FOLLOWING. A 2ND CLIP APPLIER WAS PULLED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
D5;H4: INFORMATION UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION. H6; EVALUATION CODE #400(OTHER): YEILDED JAWS. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
DURING AN ILIAC DILATATION PROCEDURE, THE CATHETER BALLOON RUPTURED ON THE SECOND INFLATION AT 10ATM. THE CATHETER WAS REMOVED AND REPLACED WITH SAME MAKE TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT OF THE IMPLANT FROM THE TEMPORARY PROSTHESIS AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
LEAD SHIELD BROKE FROM ITS SUPPORT MOUNTED FROM THE CEILING AND FELL TOWARDS THE FLOOR. THE OPERATOR OF THE SHIELD WAS HOLDING IT WHEN IT BROKE AWAY FROM THE SUPPORT. THE PT WAS NOT INJURED. PER MFR PROTECTIVE SHIELD FELL-WELD BROKE. UPON INSPECTION OF THE RETURNED WINDOW FRAME, IT WAS DISCOVERED THAT THERE WAS DAMAGE TO THE WELDED PIVOT FROM SOME PREVIOUS IMPACT. A SAFETY CABLE WAS INSTALLED INSIDE THE PIVOT AND THE PIVOT WAS RE-WELDED AND RE-ENFORCED.
THE CUSTOMER ALLEGED THE VENTILATOR'S AUDIBLE ALARM FAILED TO ACTIVATE. THE TECHNICAL SUPPORT SPECIALIST ADVISED THE CUSTOMER TO RESEAT THE CONVERSION PRINTED CIRCUIT BOARD. THE CUSTOMER DID AS HE WAS INSTRUCTED AND THE MALFUNCTION CEASED. THE CUSTOMER WILL REPLACE THE CONVERSION PRINTED CIRCUIT BOARD AS A PRECAUTION. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCURED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR THE FAILURE. PT SMOKES. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES THE CAUSE FOR FAILURE AS POST SURGICAL, PRE-EXPOSURE, LOADING OF THE IMPLANT WITH THE DENTURE. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES RESIDUAL INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
DRIVE FAILURE NO ALARM. FINAL ANALYSIS REVEALED RUSTED AND CORRODED DRIVENUT ASSEMBLY AND THREADED SEGMENT. THIS ANOMALY COULD CAUSE INACCURATE DELIVERY. SERIAL # PRE-DATES DRIVENUT MATERIAL CHANGE. THIS REPORT MAY BE REQUIRED BY MEDICAL DEVICE REPORTING REGULATIONS CONTAINED IN 21 CFR SECTION 803. THESE REGULATIONS ARE VAGUE IN A NUMBER OF RESPECTS AND SUBJECT TO DIFFERENT INTERPRETATIONS. MOREOVER, THE REGULATION REQUIRE CO TO MAKE A DECISION ON REPORTING BEFORE HAVING COMPLETE INFO, INCLUDING CO ANALYSIS OF RETURNED PRODUCT. THUS, CO DECISION TO FILE THIS REPORT SHOULD NOT BE LOOKED UPON AS ANYTHING OTHER THAN THE TRANSMITTAL OF UNCONFIRMED FIELD INFO WHICH THE FOOD AND DRUG ADMINISTRATION HAS REQUIRED MANUFACTURERS TO SUBMIT. CO BELIEVES THAT DISCLOSURE OF THE INFO REGARDING DEVICE EVAL COULD SUBSTANTIALLY HARM THE COMPETITIVE POSITION. CO SUBMITS THE INFO IN CONDIFENCE EXPECTING THAT THE FDA WILL WITHHOLD IT UNDER EXCEMPTION 4 OF THE FREEDOM OF INFO ACT. CO BELIEVES THAT ANY DISCLOSURE OF THE INFO BY A FEDERAL EMPLOYEE COULD CONSTITUTE A VIOLATION OF THE CRIMINAL LAW (18 USC SECTION 1905).
THE SERVICE REPORT SHOWS THAT THE CO'S CUSTOMER SUPPORT ENGINEER (CSE) WAS NOTIFIED OF DAMAGE CONCERNING THE VENTILATOR. THE CSE VERIFIED THE UNIT'S FILTER HEATER ASSEMBLY WAS DAMAGED AND HE REPLACED THE ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. IT WAS NOT DETERMINED HOW THE FILTER ASSEMBLY BECAME DAMAGED BUT CUSTOMER ABUSE OR MISHANDLING IS SUSPECTED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUANLITY/QUANTITY AS WELL AS PT'S SMOKING, DRINKING ALCOHOL AND DIMINISHED HYGIENE AS CAUSES FOR FAILURE. THIS FILE IS CLOSED.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT REMOVAL DUE TO FAILURE OF THE ULTRAFILTRATION PUMP THERMAL FUSE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THE TECHNICIAN AT THE FACILITY FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE FAULTY. THE THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE OHM METER SHOWED .1 OHMS, INDICATING THE THERMAL FUSE IS GOOD. THE THERMAL FUSE WAS DISASSEMBLED. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD WAS DISASSEMBLED. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME, UNTIL THE WAX INSIDE HEATS UP AND MELTS. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. SAFETY ANALYSIS: TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE CENTRYSYSTEM 3 OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PATIENT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FALLS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. FOLLOW-UP ACTION: IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT.
INVESTIGATION CONDUCTED. DR CITES MICROMOVEMENT OF THE IMPLANT FROM THE TEMPORARY PROSTHESIS ANS INSUFFICIENT BONE QUALITY WITH A QUESTIONABLE SITE. THIS FILE IS CLOSED.
WHILE THE DEVICE WAS IN USE AS AN ARTERIAL LINE, IT WAS DISCOVERED TO HAVE BEEN SEVERED. THE IV CATHETER IS REPORTED TO HAVE BEEN IN PLACE IN THE PT'S HAND. THE LOCATION OF THE SEVERED PORTION WAS VISUALIZED UNDER FLUOROSCOPY, AND THE DECISION WAS MADE NOT TO REMOVE THE SEVERED PORTION. THE SEVERED TUBING IS REPORTED TO BE IN NO DANGER OF EMBOLIZING ("NOT MOVING"), AND THE PT IS SAID TO HAVE ADEQUATE COLLATERAL CIRCULATION AT THE SITE. THE SAMPLE WAS NOT FORWARDED TO THE MFR BY THE REPORTING FACILITY.
DATE SET TO FDA: 11/8/96. A3: UNK. D-6. THE REPORTED LOT NUMBER DOES NOT CORRESPOND TO CO'S FORMAT FOR LOT NUMBERS OR TO ANY LOT ASSOCIATED WITH THE REPORTED PRODUCT. F-9: SINCE THE REPORTED LOT NUMBER IS INCORRECT, THE AGE OF THE DEVICE IS UNKNOWN, F-10. NO PT CODE ENTERED: FACILITY REPORTS THAT THE PORTION OF THE DEVICE REMAINING IN THE PT DID NOT EMBOLIZE OR OTHERWISE CAUSE ANY PT CONSEQUENCE. THEREFORE, NO CODE IS ENTERED. F-11: UNK. SEVERAL ATTEMPTS WERE MADE TO SECURE THE PRODUCT SAMPLE. THE FACILITY COULD NOT FIND THE SAMPLE. THE PT IS MOST RECENTLY REPORTED (10/22/96) TO NOT HAVE EXPERIENCED ANY NEGATIVE CONSEQUENCES OR OUTCOME. SUMMARY OF COMPLAINT INVESTIGATION: THE REPORTING FACILITY DID NOT PROVIDE A SAMPLE FOR ANALYSIS. WITHOUT THE ACTUAL SAMPLE, CO IS UNABLE TO DETERMNE THE ROOT CAUSE FOR THE REPORTED OCCURRENCE. THE FACILITY ALSO FAILED TO PROVIDE A CORRECT LOT NUMBER, WHICH WOULD HAVE ALLOWED FOR TESTING OF SISTER SAMPLES. THE FACILITY WAS ABLE TO REPORT, HOWEVER, THAT A SMALL PORTION OF TUBING REMAINS ATTACHED TO THE HUB, THE TUBING WAS MOST LIKELY DAMAGED BY AN EXTERNAL CUTTING FORCE, SUCH AS A PUNCTURE FROM A NEEDLE OR A CUT FROM SCISSORS. THE TUBING WOULD THEN MOST LIKELY BE SEVERED BY THE APPLICATION OF TENSION OR EXPOSURE TO A COMPRESSIVE FORCE. ANY IV CATHETER DEVICE CAN BE SUBJECT TO USER INDUCED SEVERANCE IF IMPROPER PROCEDURES ARE EMPLOYED. CO'S INSTRUCTIONS, WHICH ACCOMPANY THE PRODUCT, WARN AGAINST THE REINSERTION OF THE INTRODUCER NEEDLE, USE OF SCISSORS NEAR THE SITE OR THE USE OF INJECTION NEEDLES WHICH ARE LONGER THAN ONE INCH. THE USER IS ADVISED IN THE INSTRUCTIONS THAT SUCH PRACTICES CAN INDUCE A CATHETER SEVERANCE. THE FACILITY WILL BE ADVISED OF CO'S FINDINGS AND THE USUAL CAUSES OF A CATHETER SEVERANCE.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE DUE TO AN UNKNOWN CAUSE. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL, PRE-EXPOSUR LOADING OF THE IMPLANT. THIS FILE IS CLOSED.
BILATERAL BREAST CAPSULECTOMY WITH IMPLANT EXCHANGE.
THE CUSTOMER ALLEGED AN INTERMITTENT PROBLEM WITH FLUCTATING PEEP. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND WAS UNABLE TO DUPLICATE THE ALLEGED EVENT. THE CSE REPLACED THE AUTOZERO SOLENOIDS AND PRESSURE TRANSDUCER BOARD AS A PRECAUTION. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT PARTS REPLACED MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
EVAL LAB FOUND PARTS FUNCTIONED AS DESIGNED.
INVESTIGATION CONDUCTED. DR DOES NOT SUBMIT A CAUSE FOR THE FAILURE. THIS FILE IS CLOSED.
LEFT BREAST CAPSULECTOMY WITH EXCHANGE OF IMPLANT.
INVESTIGATION CONDUCTED. DR DID NO SUBMIT A POSSIBLE CAUSE FOR FAILURE BUT PT SMOKES. THIS FILE IS CLOSED. OTHER FAILED IMPLANTS-(FROM BOX D6) MODEL/CATALOG #, LOT NUMBER, 3912HL/3912HL.
USER REPORTED INSTANCES WHERE UPON INITIAL POWER UP TO MONITOR PT, DEVICE DISPLAYED "ANALYSIS SYSTEM FAULT". USER POWER CYCLED THE DEVICE AND THE CONDITION CLEARED. THERE WAS NO ADVERSE EFFECT TO THE PT REPORTED. INVESTIGATION BY MFR WAS UNABLE TO DUPLICATE REPORTED EVENT.
SECTION A.1, A.2, A.4 UNK. CUSTOMER WAS CONTACTED AND UNABLE TO PROVIDE THIS INFO. DEVICE WAS RETURNED TO MFR FOR EVAL. MFR PERFORMED NUMEROUS POWER CYCLES AND WAS UNABLE TO DUPLICATE REPORTED CONDITION. AS A PRECAUTION DEVICE WAS EXCHANGED. WILL MONITOR FOR FREQUENCY AND SEVERITY.
NEEDLE DETACHED DURING HEART SURGERY ON INFANT. NO OTHER DETAILS GIVEN.
RETURNED SAMPLES WERE EVALUATED FOR HOLDING STRENGTH AND FOUND TO MEET ALL MFG AND USP SPECIFICATIONS. NO DEFECTS WERE DETECTED THAT COULD CAUSE DETACHMENT. ACTUAL SAMPLE WAS NOT RETURNED.
THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER ALLEGED THAT THE AUDIBLE ALARM WAS INTERMITTENT. CO'S TECHNICAL SUPPORT SPECIALIST SUGGESTED THAT THE CUSTOMER REMOVE AND REPLACE THE POWER SWITCH AND VERIFY THE INTEGRITY OF THE ALARM ASSEMBLY. THE CUSTOMER REPLACED THE POWER SWITCH AND REPORTED THAT THE UNIT WAS RETURNED TO SERVICE AFTER PASSING ITS PERFORMANCE VERIFICATION TESTS. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNK WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE. THE DEVICE WAS EVALUATED BY THE CUSTOMER'S IN-HOUSE BIO-MEDICAL TECHNICIANS. THE RESULT OF THEIR EVALUATION WERE COLLECTED BY THE MFR. CO WAS NOT AUTHORIZED TO EVALUATE OR REPAIR THE DEVICE.
THE ER320 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS OF THE DEVICE WERE SPITTING OUT OF APPLIER. THERE WAS NO CONSEQUENCE TO THE PT.
H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. 11/11/96- THE REP REPORTED THE HOSPITAL COULD NOT FIND THE PRODUCTS SO IT WILL NOT BE RETURNED. RPO.
THE CUSTOMER ALLEGED THAT THE VENTILATOR WOULD NOT PASS THE EXTENDED SELF TEST (EST). THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND WAS UNABLE TO DUPLICATE THE EST FAILURE. THE CSE REPLACED THE PRESSURE TRANSDUCER BOARD AND THE AUTOZERO SOLENOID WHICH MATCHED THE REPAIR FOR THE DIAGNOSTIC CODES LOGGED IN MEMORY FROM THE CUSTOMER'S LAST EST AS A PRECAUTION. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE VENTILATOR MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
ELAB TESTING SHOWS PART FUNCTIONS AS DESIGNED WITH NO FAULTS.
INVESTIGATION CONDUCTED. DR CITES POST SURGICAL, PRE-EXPOSUR LOADING OF THE IMPLANT AS THE CAUSE FOR FAILURE. THIS FILE IS CLOSED.
TEN MINUTES INTO BYPASS, AN INCREASE OF PRESSURE WAS NOTED. THE ACT'S WERE 700; BODY TEMPERATURE WAS 26 C; AND DELTA PRESSURE WAS 300 MMHG. THE OXYGENATOR WAS CHANGED OUT AND NO PT COMPROMISE WAS REPORTED.
THE OXYGENATOR WAS REC'D FOR COMPLAINT EVAL ON 11/5/96. THE RETURNED DEVICE WAS SET-UP IN A SIMULATED PERFUSION CIRCUIT FOR PERFORMANCE TESTING UNDER THE OBSERVATION OF A TECHNICIAN. PRIOR TO TESTING, THE UNIT WAS RINSED WITH A PEROXIDE/WATER SOLUTION. AT THAT TIME, THE TECHNICIAN NOTED FIBRIN DEPOSITS IN THE FIBER BUNDLE. IN ADDITION, A GAS FLUX TEST WAS PERFORMED AT SEVERAL FLOW RATE (5,10,15,20,25 LPM) PRIOR TO THE PERFORMANCE TESTING (DRY FIBER) AND FOLLOWING THE PERFORMANCE TESTING (WET FIBER). THE RESULTS INDICATE THAT THE FIBER PORES WERE PARTIALLY BLOCKED. THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIV BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOULMONARY DIV, ITS OFFICERS, EMPLOYEES, OR AGENTS.
INVESTIGATION CONDUCTED. DR CITES CAUSE FOR FAILURE AS INSUFFICIENT BONE QUALITY/QUANTITY. THIS FILE IS CLOSED.
INVESTIGATION CONDUCTED. DR DOES NOT KNOW CAUSE FOR FAILURE. THIS FILE IS CLOSED. OTHER FAILED IMPLANTS- (FROM BOX D6) MODEL/CATALOG # LOT NUMBER 2912HL/2912HL 967680.
DURING ANGIOPLASTY, BALLOON STENT WAS LOST, POSSIBLY IN PT, AFTER DETACHING FROM BALLOON (STAFF UNAWARE IF LOST IN OR OUT OF PT). NO STENT VISIBLE ON X-RAY, OR ON EXTENSIVE SEARCH OF PT ROOM AND AREA. PT'S LEFT ANTERIOR DESCENDING ARTERY THEN CLOSED AND PT TAKEN FOR EMERGENCY CABG. IT IS UNKNOWN IF THIS WAS RELATED TO STENT OR NOT AS THE PT HAD SIGNIFICANT LEFT ANTERIOR DESCENDING ARTERY DISEASE AND STENT WAS NEVER LOCATED.
PURSUANT TO INFO RECEIVED FROM THE PHYSICIAN, SHE RECEIVED THE SALINE DEVICE WITH THE INNER PACKAGING ALREADY BREACHED BEFORE SURGERY. NO ADD'L INFO REGARDING THIS OCCURRENCE THE PHYSICIAN NOTED IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
CO DEFERS TO THE PT'S PHYSICIAN AND TO ANY CHARACTERISTICS REFERENCED IN THE PRODUCT EVAL ATTACHED HERETO." ADD'L INFO IS TO BE SUBMITTED. Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "YES", IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN THE LABELING.? IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? IF "NO", IS EVENT GREATER SEVERITY THAN USUAL FOR PRODUCT? U. "SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN REPORT CONSTITUTES AN ADMISSION THAT DEVICE CAUSED TO CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUCNTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO. CO HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY TO THE EVENT REPORTED. CO DEFERS TO THE PT'S PHYSICIAN AND TO ANY CHARACTERISTICS REFERENCED IN THE PRODUCT EVAL ATTACHED HERETO."
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR THE FAILURE, POSSIBLY DUE TO DEMINISHED ORAL HYGIENE SINCE IMPLANT WAS PLACED. THIS FILE IS CLOSED. OTHER FAILED IMPLANTS - MODEL/CTALOG # 4614HL/4614HL. LOT NUMBER 966245. MODEL/CATALOG # 2912HL/2912HL. LOT NUMBER 953979.
THE SERVICE REPORT INDICATED A LOSS OF PEEP PRESSURE ON THE ANALOG AND DIGITAL READ OUT, WHEN THERE STILL WAS PRESSURE IN THE TEST LUNG. THE CO'S CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE REPORTED CONDITION. THE CSE INSPECTED THE DEVICE AND REPLACED THE AUTOZERO SOLENOID. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY  CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
INVESTIGATION CONDUCTED. DR CITES CAUSE FOR FAILURE AS MICROMOVEMENT OF THE IMPLANT FORM THE TEMPORARY PROSTHESIS AND INFECTION. THIS FILE IS CLOSED. OTHER FAILED IMPLANTS MODEL/CATALOG # 3916HL/3916HL. LOT NUMBER 954791.
INVESTIGATION CONDUCTED. DR DOES NOT CITE A CAUSE FOR THE FAILURE. THIS FILE IS CLOSED.
DURING AN RF ABLATION PROCEDURE, THE ELECTROPHYSIOLOGY SPECIALIST REPORTED HAVING TO PRESS THE RF POWER SWITCH TWICE TO SHUT OFF THE RF POWER. NO PT INJURY OCCURRED.
SUBMISSION OF INFORMATION BY CO UNDER THE MDR REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFORMATION IS REQUIRED TO BE REPORTED UNDER REGULATION, OR THAT THE DEVICE HAS MALFUNCTIONED, OR THAT THERE IS ANY CASUAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY DEATH THAT MAY HAVE OCCURRED. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. FREQUENCY AND SEVERITY STATEMENT: HAVE CONCLUDED THAT THE FREQUENCY OF THE REPORTED EVENTS IS NOT GREATER THEN IS USUAL FOR THE DEVICE. THIS FOLLOW-UP REPORT CONTAINS THE RESULTS AND CONCLUSION CODES FOR THE INITIAL REPORT, WHICH WAS SENT TO THE FDA ON 11/6/96.
MOTHER WAS IN LABOR DURING WHICH SHE INADVERTENTLY KICKED APART THE BOTTOM PORTION OF THE BIRTHING BED MATTRESS. APPROX AT THE SAME TIME THE BABY PROPULSED OUT, AND FELL THROUGH A GAP CREATED AFTER THE BOTTOM PORTION OF THE MATTRESS WAS GONE, ONTO THE FLOOR. THE UMBILICAL CORD WAS SEVERED. NURSES WERE IN ATTENDANCE. NURSE IMMEDIATELY APPLIED PRESSURE TO THE UMBILICAL CORD. NEWBORN CARE WAS PROVIDED. THE BABY WAS DISCHARGED AFTER A 4 DAY STAY.
THE SERVICE REPORT SHOWS THAT THE CUSTOMER ALLEGED THAT THE AUDIBLE ALARM WAS NON-FUNCTIONAL. THE CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE REPORTED EVENT. THE CSE REPORTEDLY REMOVED AND REPLACED THE ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. PT IS A SMOKER. THIS FILE IS CLOSED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE ER320 CLIPS WOULD NOT STAY ON THE VESSEL. CLIPS WOULD NOT CLOSE COMPLETELY, EVEN WHEN HANDLE WAS CLOSED WITH MUCH PRESSURE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D5,10; H4; INFO UNAVAILABLE. 10/14/96 1453 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/15/96 1733 DR CALLED BACK AND STATED THE CLIPS DID NOT OPPOSE. HE STATED THE TIPS WERE OFFSET BY APPROX 1 MM AND DESCRIBED THEM AS SCISSORING. THIS OCCURRED ON THE FIRST FIRING OF THE INSTRUMENT. HE ALSO STATED THE INSTRUMENT DID NOT FEEL THE SAME WHEN IT WAS FIRED. SOME CLIPS WERE ALSO DROPPED INTO THE PT AND WERE RETRIEVED. USED ANOTHER INSTRUMENT TO COMPLETE THE CASE. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
AIR COMES INTO THE CLEAR LINE, LOCATED AT THE WHITE PIECE. DEFECT WAS DISCOVERED DURING SURGERY WITH A 15 MINUTE DELAY RESULTING IN NO EFFECT ON PT. ANOTHER PACK WAS USED TO COMPLETE SURGERY.
EVAL SUMMARY FROM H23. ASPIRATION LINE WAS TESTED IN A PREMIERE MICROSURGICAL SYSTEM AND DEFECT COULD NOT BE CONFIRMED.
ADD'L INFO AND ANY CHANGE IN THE STATUS OF THIS PT WITH REGARDS TO THIS EVENT HAS BEEN REQUESTED FROM THE PHYSICIAN. AT THIS TIME, NO ADD'L INFO OR REPORTS OF MEDICAL OR SURGICAL INTERVENTION HAVE BEEN RECEIVED. IN ADDITION, NO RECORD OF IMPLANT HISTORY FOR THIS DEVICE HAS BEEN OBTAINED AT THIS TIME AND QA IS UNABLE TO VERIFY THE DEVICE REFERENCED WAS MFG BY THIS CORPORATION. BASED ON THE LIMITED INFO RECEIVED, QA CONCLUDES DEVICE FUNCTION WAS NOT ASSOCIATED WITH THIS EVENT. HOWEVER, BECAUSE EVAL OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF MIGRATION INVIVO. QA WILL ACCEPT THE PHYSICIAN'S OBSERVATIONS OF THIS AS THE CAUSE FOR THIS OCCURRENCE. SHOULD ADD'L INO BE RECEIVED, QA WILL FILE AN ADDENDUM TO THIS REPORT AS REQUIRED.
THE PT IS EXPERIENCING "CYLINDER MIGRATION INTO HIS SCROTUM". IT WAS ALSO REPORTED;..."PT DID NOT HEAL WELL AND MAY NOT ABLE HAVE THE DEVICE REPLACED."
THE VENTILATOR FAILED TO DELIVER A BREATH AND GAVE NO AUDIBLE ALARM WHILE IN APNEA VENTILATION. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND WAS UNABLE TO DUPLICATE THE ALLEGED EVENT. THE CSE DID NOTICE A ERROR CODE IN MEMORY AND REPLACED THE OXYGEN FLOW SENSOR, DURING PERFORMANCE TESTING THE INTERNAL EXHALATION VALVE WAS ALSO REPLACED DUE TO A LEAK. THE UNIT PASSED EXTENDED SELF TESTING AND ALARM FUNCTION TESTS. IT IS NOT VERIFIED THAT THE ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
COMPLAINT STATED: OPEN CIRCUIT. ANALYSIS DETERMINED: UNIT MALFUNCTIONED DUE TO BROKEN WIRE WITHIN ELECTRICAL CONNECTOR CAP. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED. REMEDIAL ACTION TAKEN: MFG AND QUALITY ASSURANCE PERSONNEL HAVE BEEN NOTIFIED.
ANALYSIS: UNIT MALFUNCTIONED DUE TO BROKEN WIRE WITHIN ELECTRICAL CONNECTOR CAP. REMEDICAL ACTION: MFG AND QUALITY ASSURANCE PERSONNEL HAVE BEEN NOTIFIED.
THE END WAS BROKEN OFF THE COLLECTION CASSETTE. DEFECT WAS DISCOVERED DURING SETUP PRIOR TO SURGERY.
EVAL SUMMARY FROM H.3. POINT CONNECTING ASPIRATION LINE WAS VISIBLY CHIPPED. CASSETTE WAS TESTED IN CO'S MICROSURGICAL SYSTEM AND NO DEFECT WAS CONFIRMED. CASSETTE FUNCTIONED NORMALLY.
THE SERVICE REPORT SHOWS THAT WHILE THE CUSTOMER SUPPORT ENGINEER (CSE) WAS PERFORMING A ROUTINE PREVENTATIVE MAINTENANCE SERVICE, HE NOTED THAT THE ALARM WIRE HAD BEEN CUT. THE CSE REPLACED THE UTILITY HARNESS CONTAINING THE ALARM WIRES. IT REMAINS UNK HOW THE WIRES HAD BECOME SEVERED. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
INVESTIGATION CONDUCTED. DR CITES INSUFFIENT BONE QUALITY AND QUANTITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
COMPLAINT STATED: LOOSE CONNECTION. ANALYSIS DETERMINED: THERMISTOR WIRE BECAME DETACHED FROM WIRE LEADS WITHIN THERMISTOR CASING CAUSING AN UNSTABLE READING. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED. REMEDIAL ACTION TAKEN: PRODUCTION SPECIFICATIONS FOR THERMISTOR PLACEMENT WITHIN THE PORT HAS BEEN REVISED TO ALLEVIATE THIS TYPE OF FAILURE. BOTH THE FREQUENCY AND SEVERITY OF THIS TYPE OF INCIDENT WILL BE CLOSELY MONITORED TO DETERMINE IF FURTHER REMEDIAL ACTION IS NECESSARY.
ANALYSIS: THERMISTOR WIRE BECAME DETACHED FROM WIRE LEADS WITHIN THERMISTOR CASING CAUSING AN UNSTABLE READING. REMEDIAL ACTION: PRODUCTION SPECIFICATIONS FOR THERMISTOR PALCEMENT WITHIN THE PORT HAS BEEN REVISED TO ALLEVIATE THIS TYPE OF FAILURE. BOTH THE FREQUENCY AND SEVERITY OF THIS TYPE OF INCIDENT WILL BE CLOSELY MONITORED TO DETERMINED IF FURTHER REMEDIAL ACTION IS NECESSARY.
INVESTIFATION CONDUCTED. DR IS UNSURE OF CAUSE FOR FAILURE BUT QUESTIONS THE IMMEDIATE EXTRACTION PLACEMENT. THIS FILE IS CLOSED. OTHER FAILED IMPLANTS MODEL/CATALOG # 4618HL/4618HL. LOT NUMBER 9303921.
QA REQUESTED RETURN OF THE EXPLANTED COMPONENTS FOR EVALUATION, HOWEVER, AT THIS TIME THEY HAVE NOT BEEN RECEIVED. SHOULD THIS STATUS CHANGE, QA WILL AMMEND THIS REPORT AS REQUIRED.
A REVISION OCCURRED ON 1/7/88 TO REPLACE THE CYLINDERS.  THIS REPORT ADDRESSES A COMPLAINT RECEIVED ON 10/15/96 THAT CLAIMED, "ONE CYLINDER SEEMS TO BE FLAT." ADD'L INFO: EXPLANT SURGERY OCCURRED ON 1/14/97 DURING WHICH THE SURGEON NOTED THERE APPEARED TO BE A COMPLETE "TRANSECTION OF THE INPUT TUBING TO THE LEFT CYLINDER." THE PUMP AND CYLINDERS WERE REMOVED AND REPLACED.
INVESTIGATON CONDUCTED. DR CITES MICROMOVEMENT OF THE IMPLANT FROM THE TEMPORATY PROSTHESIS AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
MFR COMPLETED FOLLOWING SECTIONS: A4,B6,B7, PORTIONS OF D6, D10. CORRECTIONS TO: D1 PORT-A-CATH VENOUS IMPLANTABLE ACCESS SYSTEM. D2 IMPLANTABLE ACCESS SYSTEM. D5 NA. BASELINE REPORT FOR THIS DEVICE FAMILY SUBMITTED DATED 8/27/96.
COMPLAINT STATED: CUT CENTER OF BALLOON. ANALYSIS DETERMINED: LATEX HAS A 0.75MM TEAR IN MID-BALLOON. BALLOON LATEX SHOWS SIGNS OF NORMAL AGING. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED.
ANALYSIS: LATEX HAS 0.75MM TEAR IN MID-BALLOON. BALLOON LATEX SHOWS SIGNS OF NORMAL AGING.
INVESTIGATION CONDUCTED. DR CITES INSUFFIEINCT BONE QUALITY AND SITE QUESTIONALBE AS CAUSE FOR FAIOURE. THIS FILE IS CLOSED.
COMPLAINT STATED: CUT AT ADHESIVE BAND OF BALLOON. ANALYSIS DETERMINED: SMALL TEAR DIRECTLY BELOW DISTAL ADHESIVE BAND OF BALLOON; ORIGIN UNKNOWN. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETE.
ANALYSIS: SMALL TEAR DIRECTLY BELOW DISTAL ADHESIVE BAND; ORIGIN UNKNOWN.
PT TO HOSP FOR SURGERY ON 9/5/96 FOR 1ST STAGE R BREAST RECONSTRUCTION. TISSUE EXPANDER INSERTED AND FILLED WITH 200CC STERILE SALINE. PT DISCHARGED 9/6/96. FURTHER FILLING ATTEMPTED AT DR'S OFFICE, AND DOCUMENTED AS UNSUCCESSFUL. PT RETURNED TO HOSP ON 10/15/96 FOR SURGERY. PREOPERATIVE ASSESSMENT NOTES RIGHT CHEST WITHOUT SUSPICIOUS MASS, TENDERNESS, OR SKIN CHANGES. OPERATIVE REPORT NOTES "THE CAPSULE WAS OPENED AND FREE. STRAW COLORED, ODORLESS, SEROUS FLUID WAS SUCTIONED, AMOUNTING TO APPROX 40CC. THE IMPLANT ITSELF APPEARED INTACT AND NO OBVIOUS RUPTURE OR LEAK WAS IDENTIFIED." THE IMPLANT WAS REMOVED AND A NEW IMPLANT WAS INSERTED.
REPORT RECEVIED OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
REPORT RECEIVED OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSTION.
ONE HR INTO A PROCEDURE, A MALFUNCTION ERROR CODE APPEARED ON THE UNIT'S DISPLAY. THE DEVICE WAS REPLACED WITH A SECOND UNIT AND THE CASE WAS CONTINUED. PT WAS NOT AFFECTED BY THE INCIDENT. UNIT WAS USED FOR CARDIOPLEGIA.
HOSP DID NOT FILE A REPORT FOR THIS MALFUNCTION. THE INFO IN SECTIONS A,B,C,D,E, AND F WAS OBTAINED FROM THE INITIAL COMPLAINT AND A FOLLOW UP CONVERSATION.
DURING TURP RESECTOSCOPE TIP BROKE. TIP BECAME LODGED IN THE RESECTOSCOPE. PROCEDURE COMPLETED USING A LARGER PRICE OF EQUIPMENT.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WASB USED TO COMPLETE THE PROCEDURE.
THIRD INCIDENT AT THIS FACILITY. CO'S PERSONNEL VISITED HOSP ON 10/30/96 TO RESOLVE PROBLEM.
ON 8/9/96 IT WAS REPORTED THAT THE PT HAD A SKIN FLAP INFECTION AND HAD IV ANTIBIOTIC TREATMENT AND A FLAP REVISION SURGERY. NONE OF THIS INFO WAS REPORTED TO MFR AT THE TIME. THE PT WAS AGAIN TREATED WITH ANTIBIOTICS. ON 8/28/96 THE IMPLANT SURGEON REPORTED THAT THE PT'S SKIN FLAP WAS HEALING BUT THERE WAS A SMALL HOLE AT THE SUTURE LINE. THE SURGEON STATED THAT HE ANTICIPATED COMPLETE HEALING. ON 10/3/96 THE IMPLANT AUDIOLOGIST REPORTED THAT THE SKIN FLAP HAD NOT HEALED AND EXPLANT SURGERY WAS PLANNED.
THERE WAS NO AUDIO ALARM. THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF TESTING. THE CSE REPLACED THE ALARM ASSEMBLY AS A PRECAUTION. IT IS NOT VERIFIED THAT THE ALARM MALFUNCTIONED, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
MCL20 AND MCM20 WERE USED DURING A SPLEENECTOMY. THE CLIPS WERE CROSSING AT THE LEGS. AT TIMES A CLIP WILL NOT ADVANCE AND ON THE NEXT FIRING 2 CLIPS SHOOT OUT INTO THE PT AND THE SURGEON REMOVED THE CLIPS. THE SURGEON STATED THIS HAS HAPPENED TO HIM OVER THE PAST 3 WEEKS ON OTHER CASES. BUT HE COULD NOT RECALL HOW MANY OR DATES. THERE WAS NO CONSEQUENCE TO THE PT.
THERE WAS NO AUDIO ALARM. THE CO'S CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE NO ALARM CONDITION. THE CSE INSPECTED THE DEVICE AND REPLACED THE ALARM ASSEMBLY AFTER FINDING A LOOSE CONNECTION BETWEEN THE ALARM ASSEMBLY AND THE FRONT PANEL BOARD. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
DURING A CATARACT PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
WHILE TREATING A SEMI-CONSCIOUS PT, THE PT PLACED HER HAND ON TOP OF THE 14 MM COLLIMATOR AS THE COLLIMATOR ENTERED THE UNIT. THE TREATMENT WAS IMMEDIATELY ABORTED, BUT THE PT SUFFERED LACERATIONS TO TWO OF HER FINGERTIPS. THE PT REQUIRED SEVERAL STITCHES, SUFFERED NO FRACTURES, AND IS RECOVERING.
MCL20 AND MCM20 WERE USED DURING A SPLEENECTOMY. THE CLIPS WERE CROSSING AT THE LEGS. AT TIMES A CLIP WILL NOT ADVANCE AND ON THE NEXT FIRING 2 CLIPS SHOOT OUT INTO THE PT AND THE SURGEON REMOVED THE CLIPS. THE SURGEON STATED THIS HAS HAPPENED TO HIM OVER THE PAST 3 WEEKS ON OTHER CASES, BUT HE COULD NOT RECALL HOW MANY OR DATES. THERE WAS NO CONSEQUENCE TO THE PT.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES LEAD WAS CUT OR SNIPPED APPROX. 34CMS PROXIMAL OF ELECTRODE TIP, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS NO J STIFFENER WIRE DISCREPANCIES.
PREVIOUSLY REPORTED AS SUSPECTED J RETENTION WIRE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. THE DEVICE HAS BEEN EXPLANTED. THE PHYSICIAN STATED PRE AND POST OPERATIVE INSPECTION SHOWED NO FRACTURES.
THERE WAS NO CONNECTOR IN THE IAB USER CARTON.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. THE MISSING COMPONENT WAS SUPPLIED TO THE USER. THE DEVICE CAN BE USED. NOTHING WILL BE RETURNED TO CO FOR EVAL.
THE BIOMED MGR STATED THAT IF THE AUDIO ALARM WAS PHYSICALLY TAPPED ON THAT IT WOULD WORK. THE CO CUSTOMER SUPPORT ENGINEER (CSE) WAS UNABLE TO DUPLICATE THE CONDITION. THE CSE INSPECTED THE DEVICE AND REPLACED THE ALARM ASSEMBLY AS A PRECAUTION. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE DEVICE WAS USED DURING AN APPENDECTOMY. STAPLES WOULD NOT DELIVER. THERE WAS NO CONSEQUENCE TO THE PT.
D5;H4: INFORMATION UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION. H6; EVALUATION CODE #400(OTHER): FIRING MECHANISM DAMAGED. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. DUE TO THE DAMAGED FIRING MECHANISM THE INSTRUMENT MAY BECOME DIFFICULT TO RELEASE FROM TISSUE. COMMENTS: SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
THE SVC REPORT SHOWS THAT THE AUDIO ALARM VOLUME IS TOO LOW. THE CO'S CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THAT THE VOLUME WAS TOO LOW AND THAT IT COULD NOT BE ADJUSTED. THE CSE INSPECTED THE DEVICE AND REPLACED THE AUDIO ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE SVC REPORT SHOWS THAT WHILE PERFORMING AN INCOMING EVALUATION OF THE DEVICE, THE VOLUMES WERE FOUND TO BE OUT OF SPEC. THE CO'S SVC TECH INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE DEVICE WAS USED DURING LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. INSTRUMENT MISFIRED AND JAMMING IN THE TROCAR.
A1,2,3,4; B3,7; D5, 6,10; H4: INFO NOT PROVIDED BY AFFILIATE. BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
THE SVC REPORT SHOWS THAT WHILE PERFORMING AN INCOMING EVALUATION OF THE DEVICE, THE HIGH PRESSURE LIMIT WAS FOUND TO BE OUT OF SPEC. THE CO SVC TECH INSPECTED THE DEVICE AND CLEANED THE PLUNGER SEAT AND O-RING. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
IT WAS REPROTED THAT THE BALLOON OF THIS DEVICE BURST DURING AN ANGIOPLASTY PROCEDURE OF A LESION IN THE MID CIRCUMFLEX ARTERY. ADD'L DEVICES WERE USED AFTERWARD TO SUCCESSFULLY COMPLETE THE CASE.
THIS DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. THIS EVENT IS DESCRIBED IN THE LABLING OF THE DEVICE.
COMPLAINT STATED: CUT AT DISTAL ADHESIVE BAND OF BALLOON. ANALYSIS DETERMINED: SMALL TEAR DIRECTLY BELOW DISTAL ADHESIVE BAND OF BALLOON; ORIGIN UNKNOWN. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED.
COMPLAINT STATED: CUT AT PROXIMAL ADHESIVE BAND OF BALLOON. ANALYSIS DETERMINED: LATEX RUPTURED 0.75MM ABOVE TOP OF PROXIMAL ADHESIVE BAND. BALLOON LATEX SHOWS SIGNS OF NORMAL AGING. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED.
ANALYSIS: LATEX RUPTURED 0.75MM ABOVE TOP OF PROXIMAL ADHESIVE BAND. BALLOON LATEX SHOW SIGNS OF NORMAL AGING.
IT WAS REPORTED THAT THE BALLOON OF THIS DEVICE BURST DURING AN ANGIOPLASTY PROCEDURE OF A LESION IN THE MID CIRCUMFLEX ARTERY. THE CASE WAS STOPPED AFTER THIS AND CONSIDERED SUCCESSFUL.
THIS DEVICE WAS NOT RETURNED FOR ANALYSIS. THIS EVNET IS DESCRIBED IN THE LABELING FOR THE DEVICE.
IT WAS REORTED THAT WHILE THIS DEVICE WAS BEING USED IN AN ANGIOPLASTY PROCEDURE, CONTRAST MEDIA WAS LEAKING NEAR THE HUB. THERE HAS BEEN NO CLAIM OF INJURY RELATED TO THIS EVENT. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.
REVIEW OF DHR REVEALED NO RELATED COMMENTARY. DEVICE ANALYSIS CONFIRMED THAT THERE IS A BRITTLE FRACTURE OF THE CATHETER BODYSTOCK AT THE HUB.
WHILE TAKING RESIDENT OUT OF BATH THE CHAIR BECAME DETACHED, TIPPING THE RESIDENT ONTO THE FLOOR. NO INJURY WAS SUSTAINED TO RESIDENT OR CARER.
THIS IS A CLOSE OUT REPORT BY THE FOREIGN REPORTER. INVESTIGATION: THE DEVICE WAS A BSQ WITH A LOCKING BASE. OBSERVATIONS: AFTER THE PT WAS RAISED FROM THE WATER, THE CHAIR WAS TURNED AND RESTED ON THE EDGED OF THE BATH, THE HOIST WAS THEN RAISED AND DUE TO THE BENT PICK UP HOOK THE CHAIR AND PT FELL ON THE FLOOR. CONCLUSIONS: USER ERROR. THE ONLY WAY A PICK UP HOOK WILL BEND IS IF FORCE HAS BEEN APPLIED TO THE JIB ONCE IT HAS REACHED ITS LOCKING POSIITION. CORRECTIVE ACTIONS: A NEW JIB HAS BEEN FITTED.
THE PT WAS BEING REMOVED FROM THE BATH WHEN THE SEAT TITLED AND THE PT FELL INTO THE BATH.
THE FOLLOWING IS CLOSING REPORT BY THE FOREIGN REPORTER. THE HOIST WAS CHECKED AND FOUND TO BE FUNCTIONING SATISFACTORILY. USER ERROR. THE CHAIR HAD NOT BEEN CONNECTED CORRECTLY TO THE HOIST. USER WAS INSTRUCTED ON THE PROPER OPERATION OF THE HOIST.
INJURY TO NECK OF URINARY BLADDER WHICH OCCURRED AFTER USE OF THE KIDNEY-SHAPED EXTRAPERITONEAL BALLOON DISSECTOR DURING LAPAROSOCPIC EXTRAPERITONEAL HERNIORRHAPHY.
TOWARDS THE UPPER NECK OF THE GLASS EVACUATED CONTAINER THERE IS A DARK COLORED SPOT, ALMOST BLACK, THAT LOOKS LIKE A SPOT OF MOLD OR MILDEW. THE SPOT IS NOT ON THE EXTERIOR OF THE GLASS CONTAINER. HOWEVER, RPTR CAN NOT DETERMINE IF THE SPOT IS WITHIN THE GLASS ITSELF OR ON THE SURFACE OF THE GLASS INSIDE THE CONTAINER.
ACCORDING TO THE PT'S PRIMARY SURGEON, THE ENDOARTERIAL RETURN CANNULA (EARC) & ENDOCLAMP (EAC) USED TO ESTABLISH CARDIOPULMONARY BYPASS (CPB) & CARDIOPLEGIC ARREST WERE PLACED IN THE STANDARD FASHION WITHOUT DIFFICULTY, CPB WAS STARTED. INITIALLY HIGH LINE PRESSURES WERE ENTIRELY CORRECTED WHEN THE EARC WAS PULLED BACK 2CM. SOON THEREAFTER, A 2ND LUMEN WAS SEEN IN THE AORTA BY ECHOCARDIOGRAPHY, INDICATING AN AROTIC DISECTION. A MEDIAN STEMOTOMY WAS PERFORMED. UPON INSPECTION OF THE AORTA, IN ADDITION TO CALCIFICATION, SEVERAL ULCERATIONS WERE NOTED, INDICATING AN UNDERLYING INFLAMMATORY DISEASE OF THE VESSEL WALL. THE AORTIC ARCH WAS REPAIRED & THE INTENDED LIMA-TO LAD ANASTOMOSIS WAS PERFORMED. THE OPERATION WAS FURTHER PROLONGED DUE TO "DIFFUSE BLEEDING". THE BLEEDING INCLUDED THE ANASTOMOSIS, WHICH WAS TAKEN DOWN & REDONE. THERE WAS NO REPORT OR COMPLAINT OF DEVICE MALFUNCTION. THE DEVICE WAS BEING USED IN AN APPROVED STUDY. CO SENT A NOTIFICATION LETTER TO ALL PRINCIPLE INVESTIGATORS RE-EMPHASIZING THE POTENTIAL RISK OF VASCULAR DAMAGE ASSOCIATED WITH FEMORAL CANNULATION AND THE NEED TO SCREEEN PTS FOR PERIPHERAL VASCULAR DISEASE.
THERE WAS NO REPORT OR COMPLAINT OF DEVICE MALFUNCTION. THE DEVICE WAS BEING USED IN AN APPROVED STUDY. CO SENT A NOTIFICATION LETTER TO ALL PRINCIPLE INVESTIGATORS RE-EMPHAZING THE POTENTIAL RISKS OF VASCULAR DAMAGE ASSOCIATED WITH FEMORAL CANNULATION AND THE NEED TO SCREEN PTS FOR PERIPHERAL VASCULAR DISEASE.
PICC LINE WAS NOT FUNCTIONING; UNABLE TO FLUSH. DOUBLE LUMEN CVP WAS PLACED INSTEAD. WHEN RN WENT TO PULL PICC LINE, MET WITH RESISTANCE. APPLIED CONSTANT PRESSURE, PICC LINE SNAPPED LEAVING THE REMAINDER OF THE CATHETER IN THE PT.
MD APPLIED FIXATOR TO TREAT A FRACTURED FEMUR. SUBSEQUENTLY IT WAS NOTED THAT HTE FIXATOR LOST REDUCTION. A SECOND SURGERY WAS PERFORMED TO REPLACE THE FIXATOR.
TWO DAYS POST-OP FROM A CRANIOPLASTY PROCEDURE A LUMP WAS NOTED ABOVE THE PT'S EAR ABOUT FIVE INCHES FROM THE CRANIOPLASTY SITE IN WHICH THE BONE CEMENT WAS USED. THE LUMP WAS SURGICALLY REMOVED AND FOUND TO BE MIGRATED BONE CEMENT. THERE HAVE BEEN NO OTHER CONSEQUENCES TO THE PT.
AS TECHNOLOGIST WAS REPORTEDLY MOVING THE LEAD SHIELD ASSEMBLY, WHICH WAS SUSPENDED FROM A CEILING POST, THE ASSEMBLY ALLEGEDLY FELL FROM THE CEILING POST SUPPOSEDLY STRIKING THE TECHNOLOGIST'S LEFT FOREARM AND RIGHT FINGER REPORTEDLY RESULTING IN ABRASIONS ON THE LEFT FOREARM AND RIGHT FINGER.
THIS EVENT WAS REPORTED AS FATIGUE, DYPSNEA, AND PROSTHESTIC VALAVE "DYSFUNCTION", WITH TRICUSPID REGURGITATION. NO FURTHER INFO PROVIDED.
THE PT UNDERWENT THE CVS PROCEDURE AT 11.2 WEEKS GESTATION. ONE TRANSCERVCAL PASS WAS MADE. THE PT BEGAN CRAMPING AND SPONTANEOUSLY ABORTED 2 DAYS POST CVS PROCEDURE. A D&C WAS PERFORMED.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FOOD AND DRUG ADMINISTRATION BY SIMS, INC. PURSUANT TO 21 C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFORMATION, DOES NOT CONSTITUTE AN ADMISSION BY THE COMPANY THAT A SIMS DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. UNK ENTRY THROUGHOUT THIS FORM - THIS INFO IS UNKNOWN BECAUSE IT WAS NOT RECORDED ON THE PT'S CHART. B.3. DATE LISTED IS THE DATE OF THE CVS PROCEDURE.
THE IAB WAS IN USE FOR 48 HRS WHEN IT APPEARED THAT THE BALLOON WAS LEAKING. THE PUMP ALARMED AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED AND THERE WERE NO PT COMPLICATIONS.
THE SAMPLE WAS RETURNED FOR EVAL. NO LEAK WAS FOUND IN THE BLADDER, HOWEVER THERE WAS A SEPARATION IN THE CATHETER'S CENTRAL LUMEN. BLOOD WAS NOTED ON THE INTERIOR SURFACE OF THE IAB. BLOOD MAY HAVE BEEN SUCKED INTO THE BLADDER THROUGH THE SEPARATION IN THE CENTRAL LUMEN. IT CANNOT BE DETERMINED WHEN OR HOW THE CATHETER WAS DAMAGED.
CUT AT DISTAL ADHESIVE BAND OF BALLOON. ANALYSIS DETERMINED: SMALL TEAR DIRECTLY BELOW DISTAL ADHESIVE BAND OF BALLOON; ORIGION UNK. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNITL ANALYSIS WAS COMPLETED.
REPORT ALLEGES PT RECEIVED BREAST IMPLANTS IN JULY 1972 OF AN UNK MFR. REPORT ALSO ALLEGES PT HAD REMOVAL ON AN UNK DATE AND DID NOT GIVE ANY ALLEGATIONS FOR REMOVAL; HOWEVER, PHYSICIAN STATED MEDICAL NEED FOR REMOVAL WAS DUE TO IMPLANTS BEING VERY HARD AND ENCAPSULATED.
DUE TO POTENTIAL LITIGATION, A NONDESTRUCTIVE FUNCTIONAL EVAL WAS PERFORMED ON THE C1000T. TEST INDICATED THAT THE PRIMARY RELIEF VALVE MEASURED AT 22.0 PSIG AND WAS WITHIN THE SPECIFICATION 20.5 PSIG / 24 PSIG. THE INCIDENT REPEATABILITY TEST DID RESULT WITH THE DISPERSION OF LIQUID OXYGEN FROM THE UNIT WHEN THE UNIT LAID ON ITS SIDE. (AS WARNED IN PRODUCT LABELING.) THE UNIT HAS BEEN QUARANTINED AND A REPLACEMENT SENT TO THE CUSTOMER.
THE CUSTOMER REPORTED THAT WHILE RUNNING AN HIV P24 ASSAY, THE SAMPLE HANDLER, S/N 1254, READ THE SAME SAMPLE NUMBER FOR 5 DIFFERENT POSITIONS. THE SAMPLE IN POSITION 4G HAD THE CORRECT SAMPLE NUMBER S37941. POISTIONS 4A, 4C, 4D, 4E ALSO HAD THE SAME SAMPLE NUMBER. NO ERROR MESSAGE WAS GENERATED. CO FIELD SVC ENG WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
PT WAS BEING MOVED VIA LIFT WITH 4 STAFF TO ASSIST. LIFT COLLAPSED (THE LIFTING LEVER COLLAPSED). PT FELL TO FLOOR LANDING ON SACRAL AREA. COMPLAINED OF SEVERE BACK PAIN AND DIFFICULTY BREATHING. SPINAL X-RAY NEG. PT EXPIRED 4 1/2 HRS LATER. POST-MORTEM IDENTIFIED CAUSE OF DEATH AS PULMONARY EDEMA, NOT DIRECTLY RELATED TO FALL; LIKELY DUE TO ARRHYTHMIA.
CUT AT DISTAL ADHESIVE BAND OF BALLOON. ANALYSIS DETERMINED : SMALL TEAR DIRECTLY BELOW DISTAL ADHESIVE BAND OF BALLOON; ORIGIN UNK. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED.
THIS EVENT WAS REPORTED AS FUNGAL BACTERIAL ENDOCARDITIS, VEGETATIONS ON VALVE WITH DEHISCENCE OF RING. SECONDARY WAS CONGESTIVE HEART FAILURE, TRICUSPID INSUFFICIENCY, PULMONARY EFFUSION AND PULMONARY HYPOTENSION.
MD APPLIED FIXATOR TO TREAT A FRACTURED TIBIA. SUBSDEQUENTLY IT WAS NOTED THAT THE FIXATOR LOST REDUCTION. A SECOND SURGERY WAS PERFORMED TO REPLACE THE FIXATOR.
THE CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS ASSAY, THE SAMPLE HANDLER, S/N 2279TFM DELIVERED INSUFFICIENT SAMPLE TO A CONTROL WELL. NO ERROR MESSAGE WAS GIVEN. CO FIELD SVC ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
PT ALLEGES RECEIVING 2 PENILE IMPLANTS ON AN UNK DATE AND FROM AN UNK MFR. PT ALSO ALLEGES THE IMPLANTS NEVER FUNCTIONED.
THIS EVENT WAS REPORTED AS "FUNGUS" ON THE VALVE: NO FURTHER INFO PROVIDED.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED APPROX 5MM. APPROX 11MM AND APPROX 37MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF THE J STIFFENER WIRE MEASURES APPROX 51MM AND MIGRATED DOWN LEAD BODY APPROX 41MM PROXIMAL OF WELD SITE. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE OUTER ANODE COIL WIRE IS FRACTURED APPROX 20CM PROXIMAL OF THE FIXATION HELIX HOUSING ELECTRODE TIP. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS REC'D WITH ALL RECORDED MEASUREMENTS ADDING UP TO APPROX 88MM.
DEVICE ANALYSIS IS PROVIDED. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR, FEMORAL. TECHNIQUE/TOOLS: DOTTER BASKET/SNARE, INTRAVASCULAR COUNTER TRACTION. NO COMPLICATIONS.
THE CUSTOMER REPORTED THAT THE SAMPLE HANDLER, S/N 2196, FAILED TO ASPIRATE SAMPLE OR DILUENT IN POSITION 3 ACROSS ASSAYS. NO ERROR MESSAGE WAS GENERATED. CO FIELD SVC ENGINEER IS ON -SITE TO EVALUATE INSTRUMENT PERFORMANCE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
REMOVAL ACETABULAR SHELL DUE TO LACK OF FIXATION: BONE INGROWTH AND/OR SCREW FIXATION. ADD'L CAT #: 6290-5-045.
THE CUSTOMER REPORTED THAT WHILE RUNNING AN HCV ASSAY, THE SAMPLE HANDLER, S/N 2356, MISREAD A SAMPLE BARCODE. THE LABEL WAS READ AS "080FG04387" INSTEAD OF "020GS04387". NO ERROR MESSAGE WAS GENERATED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
CUT AT DISTAL ADHESIVE BAND OF BALLOON. ANALYSIS DETERMINED: SMALL TEAR DIRECTLY BELOW DISTAL ADHESIVE BAND OF BALLOON; ORIGIN UNK. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 1/16/87. SHE ALSO ALLEGES REMOVAL AND REPLACEMENT OF DEVICES ON 2/23/95 BECAUSE OF CAPSULAR CONTRACTURE.
THIS EVENT WAS REPORTED AS: PERIVALVULAR LEAK AND REGURGITATION. NO FURTHER INFO PROVIDED.
RUPTURED BALLOON. ANALYSIS DETERMINED: SMALL TEAR DIRECTLY BELOW DISTAL ADHESIVE BAND OF BALLOON: ORIGIN UNK. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED.
THE CATHETER WAS PLACED WITHOUT INCIDENT.  FOUR DAYS LATER, THE CATHETER WAS REMOVED AND FOUND TO BE 3 CM SHORTER THAN WHEN PLACED. A DYE STUDY AND AN X-RAY WERE DONE, BUT THE FRAGMENT WAS NOT LOCATED.
THE REPORTER DESCRIBED THE DISTAL END OF THE CATHETER AS BEING "JAGGED AND HAD A SNAKE TONGUE LOOK." THE LOCATION OF THE CATHETER IS UNKNOWN.
THIS EVENT WAS REPORTED AS FATIGUE, DYPSNEA AND PROSTHETIC VALVE "DYSFUNCTION" WITH TRICUSPID REGURGITATION. NO FURTHER INFO PROVIDED.
DURING PREP IT WAS NOTICED THAT THE CONNECT OR ON THIS DEVICE WAS DEFECTIVE. THE CONNECTOR WAS "STRIPPED". THERE WAS NO PT INVOLVEMENT. THE DEVICE IS NOT BEING RETURNED FOR CO'S ANALYSIS.
PT ALLEGES RECEIVING BREAST IMPLANTS IN JULY 1986. PT ALSO ALLEGES HAVING CONTRACTURE; THEREFORE, HAD REMOVAL AND REPLACEMENTS ON 9/1/86.
THE INITITAL SOURCE OF THE INFO WAS THE PT. THE DEVICE IMPLANT WAS NOT REGISTERED WITH THE MFR. THE PT STATED THAT SHE WOULD CALL BACK WITH ADD'L INFO SINCE SHE WAS NOT IN HER OWN RESIDENCE AT THE TIME OF THE CALL TO THE MFR. THE PT DID NOT DO SO. TWO DIFFERENT PT TELEPHONE NUJMBERS WERE TRIED. ONE LISTING WAS DISCONNECTED AND THE OTHER HAD BEEN CHANGED TO AN UNLISTED NUMBER. THREE INSTITUTIONS WERE CONTACTED IN AN ATTEMPT TO GAIN ADD'L INFO SUCH AS IMPLANT AND EXPLANT DATES, DEVICE MODEL AND SERIEAL NUMBER AND THE WHEREABOUTS OF THE EXPLANTED DEVIC43E. TWO OF THOSE INSTITUTIONS RESPONDED BY SUBMISSION OF THE ATTACHED MEDWATCH FORM.
PINHOLE RUPTURE. ANALYSIS DETERMINED: LATEX RUPTURED IN MID BALLOON. BALLOON LATEX SHOWS SIGNS OF NORMAL AGING. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED.
9/9/96 ADMITTED WITH DIAGNOSIS ACUTE INTRACRANIAL/HEMORRHAGE RULE OUT ANEURYSM. 9/9 (1 PM)-RIGHT EVD INSERTED PER "TWIST DRILL VENTRICULOSTOMY" TO MONITOR ICP. 9/14 (11 PM) PULLED OUT ICP CATH. 9/15 (11 PM) 9/16 (2:45 PM)-PATIENT BEHAVIORAL CHANGES. 9/17 (6:30 AM)-REPEAT CT. PROXIMAL ICP CATH RIGHT VENTRICLE. 9/17 (6:30 PM)-IMPRESSION NO GROSS INTERNAL NEURO CHANGES. NEURO DYNAMICALLY IMPROVED. PLAN: CONTINUE PRESENT MGMT. 9/17/ (7 PM)-ICP CATHETER REMOVED FROM SCALP WOUND. PT MORE RESTFUL. 9/23-CONTINUES OT IMPROVE.
PT ALLEGES RECEIVING BREAST IMPLANTS ON OCT. 1974. PT ALSO ALLEGES HER BREASTS, "WENT AS HARD AS A CRICKET BALL"' ONE HARDER THAN THE OTHER. REPORT STATES IN NOV. 1991 CLINICAL DIAGNOSIS INDICATED BILATERAL CAPSULAR CONTRACTURE; THEREFORE, ON 11/4/91 SHE HAD REMOVAL AND REPLACEMENT.
THIS EVENT WAS REPORTED AS THRROMBOSIS. THIS DEVICE REMAINS IMPLANTED. NO FURTHER INFO PROVIDED.
THE CATHETER WAS REPORTED TO HAVE TWO HOLES THAT WERE LEAKING.
THE CATHETER WAS FLUSHED AND A LEAK WAS SEEN JUST DISTAL TO THE CUFF. UNDER MAGNIFICATION, THE BURST SITE WAS 3/10" LONG. THE BURST SITE'S VENEER WAS SMOOTH AND DULL. TACTILE EXAMINATION OF THE CATHETER DISCLOSED HARDENED LUMPS INSIDE THE TUBING JUST DISTAL TO THE BURST SITE. THIS MATERIAL APPEARS TO BE DRIED BLOOD OR CRYSTALLIZED MEDICATION THAT HAD OCCLUDED THE CATHETER. THE CATHETER IS BELIEVED TO HAVE BURST DUE TO OVER PRESSURIZATION OF THE CATHETER DUE TO OCCLUSION OF THIS MATERIAL.
PT ALLEGES RECEIVING BREAST IMPLANTS ON 9/1/86 AS REPLACEMENTS. PT ALSO ALLEGES IN 1994 SHE DEVELOPED SWELLING, TENDERNESS, SHRINKING AND DROPPING. PHYSICIAN'S NOTE STATES, "RADIOLOGICAL EVIDENCE OF IMPLANT LEAKAGE."
DURING PREP IT WAS NOTICED THAT THE CONNECTOR ON THIS DEVICE WAS DEFECTIVE. THE CONNECTOR WAS "STRIPPED". THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
PER PHONE CONVERSATION WITH UF: PT BECAME AGITATED AND PULLED CATHETER OUT OF CRANIUM. PROXIMAL TIP OF CATHETER BROKE OFF AND REQUIRED REMOVAL THROUGH SCALP WOUND.
NOTE: THE INFO IN SECTION F-10 WAS SUPPLIED BY THE MFR BASED ON VERBAL INFO RECEIVED. THE INFO REPORTED IN THE REMAINDER OF SECTION F WAS SUPPLIED BY THE UF REPORT #140288-1996-0002 (COPY FOLLOWS). BASED UPON INFO RECEIVED FROM THE UF, IT DOES NOT APPEAR THAT A PROBLEM WITH THE PRODUCT CAUSED THE EVENT.
OPEN CIRCUIT. ANALYSIS DETERMINED: THERMISTOR WIRE BECAME DETACHED FROM WIRE LEADS WITHIN THERMISTOR CASING CAUSING AN UNSTABLE READING. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED. REMEDIAL ACTION TAKEN: PRODUCTION SPECS FOR THERMISTOR PLACEMENT WITHIN THE PORT HAS BEEN REVISED TO ALLEVIATE THIS TYPE OF FAILURE. BOTH THE FREQUENCY AND SEVERITY OF THIS TYPE OF INCIDENT WILL BE CLOSELY MONITORED TO DETERMINE IF FURTHER REMEDIAL ACTION IS NECESSARY.
PT ALLEGES RECEIVING IMPLANTS IN 1986 FROM AN UNK MFR. PT ALSO ALLEGES ONE IMPLANT "SEEMS" LIKE IT IS GETTING SMALLER, HOWEVER; NO OTHER SPECIFICS WERE GIVEN.
THIS EVENT WAS REPORTED AS "FAILURE" AND "DYSFUNCTION". NO FURTHER INFO PROVIDED.
THE CATHETER WAS REPORTED TO BE NONFUNCTIONAL, SO IT WAS REMOVED FROM THE PATIENT. AFTER REMOVAL, THE CATHETER WAS FOUND TO BE SHORTER THAN WHEN IT HAD BEEN PLACED. THE REPORTER THOUGHT THAT ONE PIECE OF THE MISSING CATHETER HAD BEEN FOUND IN THE CATHETER HUB.
THE CATHETER BREAK SITE APPEARED GRANULAR AND DULL WITH SPOTS OF JAGGEDNESS. THE TUBING HAS BEEN ELONGATED AND NECKS DOWN LENGTH WISE AT THE BREAK SITE. THE BROKEN ENDS DO MATCH SO IT IS UNLIKELY THAT A PORTION OF THE CATHETER IS MISSING. NO LEAKS OR ABNORMALITIES WERE NOTED. THE BREAK APPEARED TO HAVE BEEN CAUSED BY A TENSILE FORCE PLACED UPON THE CATHETER DURING REMOVAL.
THIS EVENT WAS REPORTED AS: LEAFLET DISRUPTION, INSUFFICIENCY AND "DEGENERATION:. NO FURTHER INFO PROVIDED.
H3: EXAMINATION OF THE VALVE IN LABORATORY REVEALED VEGETATIVE MATERIAL WITHIN EACH CUSP WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA AND MULTIPLE DISRUPTIONS. CALCIFICATION WAS ALSO NOTED THROUGHOUT EACH CUSP WHICH CONTRIBUTED TO STENOSIS OF THE VALVE AND FURTHER DISRUPTIONS. INCOMPLETE COAPTATION RESULTED FROM THE MULTIPLE LEAFLET DISRUPTIONS. X-RAY ANALYSIS REVEALED EXTENSIVE CALCIFICATION WITHIN THE AORTIC WALL, BELLY AND FREE MARGIN OF EACH CUSP. STENT DISTORTION WAS ALSO NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. HISTOLOGICAL ANALYSIS WAS COMPLETED BY CO'S CONSULTANT PATHOLOGIST. SECTIONS STAINED BY A VARIETY OF TECHNIQUES WERE AVAILABLE FOR EXAMINATION. GROSS EXAMINATION REVEALED A PORCINE BIOPROSTHETIC VALVE WITH SEVERAL ABNORMALITIES. THERE WAS A PERFORATION IN THE BELLY REGION OF ONE LEAFLET AND DETACHMENT OF THE LEAFLETS FROM TWO COMMISURES. THERE WERE GRANULARITIES AT THE COMMISSURES AND EVEN MORE PROMINANTLY ON THE INFLOW SURFACES OF THE LEAFLETS. MICROSCOPIC EXAMINATION REVEALED MARKED DIFUSE DEGENERATIVE CHANGES OF THE COLLAGEN WITH SEPARATION OF BUNDLES AND INSUDATION OF PLASMA PROTEINS AND LIPIDS. THERE WAS DIFFUSE SEVERE CALCIFICATION. THERE WAS EXTENSIVE MURAL THROMBOSIS WITH ACUTE AND CHRONIC INFLAMMATORY CELLS, AND MULTINUCLEATED GIANT CELLS ON AND UNDER THE SURFACES OF THE LEAFLETS. THERE WERE NUMEROUS COLONIES OF BACTERIA WHICH SHOW MARKED DEGENERATIVE CHANGES. GRAM STAIN REVEALED ONLY FEW INTACT GRAM POSITIVE COCCI. GIEMSA STAIN SHOWED MUCH MORE NUMEROUS BACTERIAL FORMS. THE EXTERNAL SURFACE OF THE AORTIC WALL ALSO HAD INFLAMMATORY INFILTRATES. IN SUMMARY, THIS VALVE SHOWED BIOPROSTHETIC ENDOCARDITIS ASSOCIATED WITH MARKED DEGENERATION AND EXTENSIVE CALCIFICATION OF THE LEAFLETS. THE LARGE NUMBER OF DEGENERATED BACTERIA AND RELATIVE PAUCITY OF ACUTE INFLAMMATORY CELLS SUGGEST THERAPEUTIC INTERVENTION. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO ENDOCARDITIS. THESE FINDINGS WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY. H6: 86 = X-RAY ANALYSIS.
PT RECEIVED A CHIN IMPLANT 10 YEARS AGO (I.E. 1986).  REPORTER ALSO ALLEGES PT HAD A FEW TWINGES INITIALLY AND THEN THE LAST MONTH (I.E. SEPT. 1996) HAS HAD PAIN. SHE ALSO STATES PT'S DR. WANTS TO DO EXPLORATORY SURGERY BECAUSE HE THINKS A PEICE HAS BROKEN OFF.
INTERNAL CAROTID BALLOON WOULD NOT DEFLATE. SMALL LUMEN WAS BLOCKED WITH UNIDENTIFIED MATERIAL 1 CM DISTAL OF ARM. ATTEMPTING TO CHARACTERIZE THE UNKNOWN MATERIAL.
INITIAL REPORT INDICATED THE INTERNAL CAROTID BALLOON WOULD NOT DEFLATE DUE TO BLOCKAGE OF AN UNIDNETIFIED MATERIAL. THE "DEBRIS" IN THE INFLATION LUMEN WAS IDENTIFIED BY EDX AS SODIUM CHLORINE. THIS MOST LIKELY PRECIPITATED FROM A COLD SALINE SALINE SOLUTION USED TO INFLATE THE BALLOONS DURING PRETEST. CO HAS RECOMMENDED TO THE FACILITY USING ROOM TEMPERATURE SALINE SOLUTIONS TO REDUCE THE LIKELIHOOD OF PRECIPITATES.
REPORTED INFO: FAULTY THERMOSTAT CAUSED SUMP WATER TO OVERHEAT AND SUSPORATE. THE STEAM ESCAPED THE CHAMBER WHEN THE ACCESS DOOR WAS OPENED AND THE OPERATOR WAS SLIGHTLY BURNED TO THE LEFT HAND KNUCKLES (NOT A SERIOUS INJURY). REPORTABLE MALFUNCTION: STEAM CAUSED BY THE SUMP WASTER EVAPORATION WILL ESCAPE FROM WASHER AND NIGHT CAUSE SEVERE BURNS IF ALL OF THE FOLLOWING CONIDTIONS ARE MET SIMULTANEOUSLY. THERMOSTAT FAILURE WITH CONTRACTOR CLOSED DUTING THE THERMAL RINSE PHASE; OPERATOR NOT FOLLOWING WARNING LABELS AND OPENS CHAMBER DOOR BEFORE CYCLE COMPLETION; OPERATOR NOT WEARING RECOMMENDED PROTECTIVE EQUIPMENT (GLOVES AND FACE SHIELD) AS PER LABELING OF WASHER.
THE EVALUATION SUMMARY REFERRED TO IN SECTION H.3 WAS INITIALLY ATTACHED WITH FIRST REPORT.
OPEN CIRCUIT. ANALYSIS DETERMINED: THERMISTOR WIRE BECAME DETACHED FROM WIRE LEADS WITHIN THERMISTOR CASING CAUSING AN UNSTABLE READING. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMIEND UNTIL ANALYSIS WAS COMPLETED. REMEDICAL ACTION TAKEN: PRODUCTION SPECS FOR THERMISTOR PLACEMENT WITHIN THE PORT HAS BEEN REVISED TO ALLEVIATE THIS TYPE OF FAILURE. BOTH THE FREQUENCY AND SEVERITY OF THIS TYPE OF INCIDENT WILL BE CLOSELY MONITORED TO DETERMINE IF FURTHER REMEDIAL ACTION IS NECESSARY.
PT ALLEGES RECEIVING AN IMPLANT IN 1978 FROM AN UNK MFR. PT ALSO ALLEGES SHE IS HAVING PROBLEMS WITH IT. NO OTHER SPECIFICS WERE GIVEN.
THIS EVENT WAS REPORTED AS LEAFLET DISRUPTION. NO FURTHER INFO PROVIDED.
REPORT ALLEGES PT RECEIVED BREAST IMPLANTS IN JULY 1972 OF AN UNK MFR. REPORT ALSO ALLEGES PT HAD REMOVAL ON AN UNK DATA AND DID NOT GIVE ANY ALLEGATIONS FOR REMOVAL; HOWEVER, PHYSICIAN STATED MEDICAL NEED FOR REMOVAL WAS DUE TO IMPLANTS BEING VERY HARD AND ENCAPSULATED.
DEVICES WERE RETURNED FOR ID PURPOSES ONLY. UPON VISUAL EXAMINATION, ONE DEVICE WAS FOUND TO BE INTACT WITH UNK SHELL INTEGRITY, AND THE OTHER DEVICE WAS INTACT WITHOUT FULL SHELL INTEGRITY. THE DEVICES WERE RETURNED TO AUSTRALIA ON NOV. 18, 1996 WITH FURTHER EVALUATION.
CALLER FROM THE ACCOUNT WAS CONCERNED ABOUT THE ACCURACY OF THE UNIT EVEN THOUGH IT DID DELIVER WITHIN THE MFR'S SPECIFICATIONS. FIVE STATIONS WERE IN USE TO FILL A FINAL BAG. FOUR STATIONS HAD PROGRAMMED AND ACTUAL DELIVERED VOLUMES IN AGREEMENT. THE FIFTH STATION (STATION #6) WAS PROGRAMMED TO DELIVER 250ML OF LIPID. IT DELIVERED 248ML THEN DISPLAY JUMPED TO 258ML AND WENT INTO A COMPLETE MODE. THIS WAS THE FIRST BAG OF THE DAY TO BE COMPOUNDED. THERE WERE NO ALARM CONDITIONS AND NO CALIBRATION PROBLEMS. USER ADVISED NOT TO USE THE UNIT, WHICH WAS SWAPPED OUT. THE TRANSFER SET (LOT# H96C26210) INCLUDED. THERE WAS NO PT INVOLVEMENT.
SECTION F COMPLETED BY CO BASED ON INFO RECEIVED FROM THE REPORTER. EVALUATION: THE UNIT WAS DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
THE VENTILATOR WAS CONNECTED TO A SEDATED PT WITH THE ATTACHED SETTINGS WHEN THE ET TUBE REPORTEDLY BECAME CLOGGED WITH BLOOD. WHEN THE STAFF CAME IN THE ROOM THEY FOUND THE VENTILATOR AUTOCYCLING AND NO ALARMS. THE VENTILATOR WAS USED IN CONJUNCTION WITH ABIOMED TESTED THE VENTILATOR AND WAS UNABLE TO PRODUCE THE LACK OF ALARM SITUATION, THEY REPORT ALL ALARMS FUNCTIONAL. A CO REP WILL EVALUATE THE VENTILATOR AT THE HOSP.
THE VENTILATOR WAS EVALUATED BY A CO FIELD REP, THE REPORTED ALARM PROBLEM COULD NOT BE DUPLICATED. THE MFR HAS CONCLUDED THAT THE LACK OF ALARM WAS DUE TO THE USER SETTING THE LOWER EXPIRED MINUTE VOLUME LIMIT TOO LOW (2L/MIN). THE OPERATING MAUNUAL DESCRIBES THE PROPER
DISCONNECTION ON THERMISTOR CABLE AT 817. THE CATHETER AND COC WERE PREPARED WITH ORDINARY MANNER, BUT UNREASONABLE VALUE WAS INDICATED. CO MEASUREMENT WAS PERFORMED SUCCESSFULLY WITH NEW CATHETER. ANALYSIS DETERMINED: DISTAL THERMISTOR WIRE BECAME DETACHED FROM WIRE LEADS WITHIN THERMISTOR CASING CAUSING AN UNSTABLE READING. WARRANTLY ON THIS PRODUCT EXPIRED ON 5/31/96. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED. REMEDIAL ACTION TAKEN: PRODUCTION SPECS FOR THERMISTOR PLACEMENT WITHIN THE PORT HAS BEEN REVISED TO ALLEVIATE THIS TYPE OF INCIDENT WILL BE CLOSELY MONITORED TO DETERMINE IF FURTHER REMEDIAL ACTION IS NECESSARY.
DURING PROCEDURES IT WAS NOTED THAT BOTH PRESSURE DOMES WERE LEAKING. UNITS WERE REPLACED WITH NO INCIDENT TO THE PATIENT. PATIENT IS FINE.
H-10 ALL UNK INFO REQUESTED BUT NOT RECEIVED H-10-SECTION F10 PROVIDED BY THE MANUFACTURERH-10-SECTION H CODE 81 NO SAMPLE AVAILABLEH-11-SECTION F10 DEVICE CODE LABEL
HIGH PRESSURE WAS NOTED SIX MINUTES INTO CARDIOPULMONARY BYPASS. THE ACT'S AT THE BEGINNING OF THE PROCEDURE WERE GREATER THAN 400 SEC. AND DROPPED TO LESS THAN 250 SEC. THE PT HAD BLEEDING PROBLEMS IN THE ICU POST OPERATIVELY.
THE OXYGENATOR WAS RECEIVED FOR COMPLAINT EVALUATION ON 11/6/96. THE RETURNED DEVICE WAS SET-UP IN A SIMULATED PERSUION CIRCUIT FOR PERFORMANCE TESTING UNDER THE OBSERVATION OF A TECH. PRIOR TO TESTING, THE UNIT WAS RINSED WITH A PEROXIDE/WATER SOLUTION. VISUAL EXAM NOTED NO PHYSICAL ANOMALIES ON THE RETURNED OXYGENATOR. TESTING WAS PERFORMED AND THE CO2 TRANSFER, O2 TRANSFER, AND BLOOD PRESSURE DROP WERE FOUND TO BE OUTSIDE OF THE SPECIFICATION PARAMETERS. IN ADDITION, A GAS FLUX TEST WAS PERFORMED AT SEVERAL DIFFERENT FLOW RATES (5, 10, AND 15 LPM) PRIOR TO THE PERFORMANCE TESTING (DRY FIBER) AND FOLLOWING THE PERFORMANCE TESTING (WET FIBER). THE RESULTS INDICATES THAT THE FIBER PORES WERE PARTIALLY BLOCKED. DISCLAIMER STATE: THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFORMATION OR CONLCUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEW OR CONCLUSIONS OF MEDTRONIC CARDIOPLUMONARY DIVISION, IT OFFICERS, EMPLOYEES, OR AGENTS.
DURING A PT TREATMENT ON THIS MACHINE, THE PT'S BLOOD PRESSURE DROPPED TO 80/P, AND THE PT WENT INTO RESPIRATORY AND CARDIAC ARREST. THE FACILITY ALLEGES THAT THE PT'S CIRCULATION WAS RESTORED BY ADMINISTERING CPR AND OXYGEN. THE PT WAS ALSO GIVEN 250 ML OF SALINE AND 1 MG OF ATROPINE. THE TREATMENT WAS TERMINATED AFTER THIS. THE FACILITY ALLEGES THAT THE PT'S POST-TREATMENT WEIGHT WAS 2.0KG BELOW HIS TARGET WEIGHT.
THE PT INVOLVED IN THIS EVENT HAS NOT SUSTAINED ANY PERMANENT DAMAGE OR IMPAIRMENT RELATED TO THIS EVENT. DEVICE EVAL SUMMARY: A FOREIGN AGENT OF THE MFR EXAMINED THE DEVICE AFTER THE EVENT. THIS SERVICE PERSON FOUND THE FLOW EQUALIZER ON THE DEVICE TO BE MALFUNCTIONING. DURING HIS EXAM OF THE DEVICE, HE FOUND A SMALL PARTICLE LODGED IN A VALVE IN THE FLOW EQUALIZER OF THE DEVICE. HE REMOVED THE PARTICLE FROM THE VALVE AND PERFORMED FUNCTIONAL TESTS ON THE DEVICE. HE FOUND THE DEVICE TO BE WITHIN SPECIFICATIONS AND OPERATING AS INTENDED. THE PARTICLE FROM THE DEVICE WAS RETURNED TO THE MFR FOR TESTING. THE PARTICLE WAS FOUND TO BE A PIECE OF NYLON, THE MFR HAS CONCLUDED THAT THE SOURCE OF THIS PARTICLE WAS EXTERIOR TO THE DEVICE. F1: NO REPORT SUBMITED BY THE USER FACILITY, THIS REPORT IS FROM THE MFR.
DEVICE NOT EVALUATED BY MFR. THE DEVICE IN QUESTION DID NOT MALFUNCTION. THE DEVICE IS DESIGNES SUCH THAT WHEN IN ALARM CONDITION, THREE INDICATIONS OF THE EVENT ARE GIVEN: 1.ALARM TONE, 2. RED WARNING MESSAGE ON SCREEN, 3. CHARTO STRIP RECORDING. THE ALARM TONE CAN BE TURNED DOWN, BUT NOT TOTALLY OFF. CO PROVIDES INSERVICES, OPERATOR AND SERVICE MANUALS INCLUDING ALL WARNINGS PROSCRIBED BY THE FDA. IT IS THE RESPONSIBILITY OF THE USER INSTITUTION TO ESTABLISH AND ENFORCE SAFE STANDARDS FOR ITEMS LIKE ALARM VOLUME AND ALARM LIMITS.
DR. REPORTED THAT AN ABUTMENT BROKE IN FUNCTION.
STAFF MEMBERS IN THE CCU INDICATED THAT THEY WERE TREATING A PT (AGE AND GENDER UNKNOWN) USING "HANDS FREE PADS". THEY INDICATED THAT THE UNIT DID NOT DISCHARGE. THE PT SUBSEQUENTLY EXPIRED.
THE CLINICAL ENGINEER INDICATED THE DEVICE WOULD NOT BE RETURNING TO THE MFR FOR EVALUATION, BECAUSE THERE WAS NOTHING WRONG WITH THE DEVICE, AND THE MALFUNCTION WAS A RESULT OF OPERATOR ERROR.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. ACCURATE MEASUREMENTS COULD BE TAKEN DUE TO MODIFICATIONS TO THE CUFF REGION. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE MD'S OFFICE.
THE UNIT HAD A FREE FLOW OF FLUID ABOUT 5-10 SECONDS AFTER THE POWER WAS TURNED ON BUT BEFORE IT WAS PROGRAMMED. THE WEIGHING CHAMBER WAS FILLED TO WITHIN 1/2" OF THE TOP AND THEN THE UNIT STOPPED PUMPING ON ITS OWN. THE CALLER DID NOT KNOW WHICH SOLUTION HAD BEEN PUMPED OR WHETHER ANY VALUES WERE REGISTERED ON THE DISPLAYS. ALL OCCLUDER DOORS WERE CLOSED AND THERE WERE NO ALARMS WHEN THIS OCCURRED. HE POWERED THE UNIT DOWN, RECYCLED THE POWER AND PURGED THE WEIGHING CHAMBER. AT THIS POINT THE USER WAS UNABLE TO CALIBRATE THE UNIT. THE USER WAS ADVISED NOT TO USE THE UNIT WHICH WAS SWAPPED OUT. THERE WAS NO PT INVOLVEMENT.
SECTION F WAS COMPLETED BY CO BASED ON INFO RECEIVED FROM THE REPORTER. EVAL: THE UNIT WAS RECEIVED DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL ACCURACY TESTS, HOWEVER FAILED LOWER STATION BOTTLE HOLDER CONTINUITY. THE COMPLAINT COULD NOT BE DUPLICATED.
WHILE PERFORMING UNRELATED SVC, THE SVC TECH (ST) FOUND THAT THE AUDIBLE ALARM WAS NONFUNCTIONAL. THE ST INSPECTED THE DEVICE AND RESOLDERED A BROKEN WIRE CONNECTION ON THE MODE SWITCH. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
ON 10/11/96 CO RECEIVED INFO ALLEGING THAT MODEL N-20 PULSE OXIMETER DISPLAYED AN OXYGEN SATURATION READING OF 100% OXYGEN SATURATION ON A HOSP EMPLOYEE THAT HAD FAINTED FOLLOWING AN "ASTHSMA ATTACK". THE HOSP SAID THEY "DOUBTED" THE READINGS, BUT DID NOT PROVIDE ANY BASIS FOR COMPARISON OF THE ACTUAL OXYGEN SATURATION OF THE PT AND THE OXYGEN SATURATION READING DISPLAYED ON THE N-20. THE HOSP HAS STATED THAT THERE WAS NO PT HARM OR CHANGE IN TREATMENT MADE AS A RESULT OF THE DISCREPANT READINGS.
THE N-20 PULSE OXIMETER WAS RETURNED TO CO'S FAILURE INVESTIGATION DEPARTMENT. THE HOSPITAL'S CLAIM OF THIS N-20 PROVIDING HIGH READINGS WERE VERIFIED. THE ROOT CAUSE OF THE FAILURE WAS ISOLATED TO AN OPEN CONNECTION BETWEEN THE CPU IC AND THE SOCKET IN WHICH THE CPU IS MOUNTED.
DISCONNECTION ON THERMISTOR CABLE AT 407-1HSK. CATHETER FAULT WAS INDICATED WHEN CATHETER CONNECTED TO COC. ANALYSIS DETERMINED: THERMISTOR WIRE BECAME DETACHED FROM WIRE LEADS WITHIN THERMISTOR CASING CAUSING AN UNSTABLE READING. THE UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED. REMEDIAL ACTION TAKEN: PRODUCTION SPECS FOR THERMISTOR PLACEMENT WITHIN THE PORT HAS BEEN REVISED TO ALLEVIATE THIS TYPE OF THIS TYPE OF INCIDENT WILL BE CLOSELY MONITORED TO DETERMINE IF FURTHER REMEDIAL ACTION IS NECESSARY.
X-TUBE ASSEM 17" X 16". DEALER CLAIMS X-TUBE BROKE AT CTR BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITEED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING INTUBATION ATTEMPT THE LARYNGOSCOPE BLADE BROKE OFF IN PT'S MOUTH INTERFERING WITH ABILITY TO INTUBATE AND VENTILATE THE PT. THIS CAUSED THE PT'S TOOTH TO BREAK. DURING INBILITY TO VENTILATE, PT BECAME HYPOXIC AND SUBSEQUENT CARDIAC ARREST. ICU STAFF PRESENT DURING EVENT. PT CONTINUE TO BE ICU POST ARREST.
PT EXPRIENCED VENTRICULAR FIBRILLATION REQUIRING DEFIB DURING A VENTRICULAR PROGRAMMED ELECTRICAL STIMULATION STUDY. THE PT WAS SUCCESSFULLY REVERTED. THE SITE SUSPECTED EQUIPMENT MALFUNCTION, EITHER WITH THE STIMULATOR OR ANOTHER MFR'S MONITORING EQUIPMENT. BOTH DEVICES WERE REMOVED FROM SERVICE. THE STIMULATOR WAS TESTED BY HOSP PERSONNEL. NO MALFUNCTION  WAS FOUND. THE DEVICE WAS THEN RETURNED TO CO FOR EVAL. COMPONENTS OF THE MONITORING EQUIPMENT WERE ALSO RETURNED TO THAT MFR FOR EVAL. THE EVENT OCCURRED 9/18/96. CO WAS NOT AWARE OF ANY POSSIBLE EQUIPMENT MALFUNCTION. UNTIL 10/10-11/96.
VISUAL INSPECTION REVEALED NO OBVIOUS PROBLEMS OTHER THAN NORMAL WEAR AND TEAR FOR A UNIT OVER TEN YEARS OLD. ELECTRICAL AND FUNCTIONAL TESTING FAILED TO REVEAL ANY MALFUNCTION. IT WAS ATTEMPTED TO INDUCE A FAILURE THROUGH DISRUPTION OF THE POWER SUPPLY. INTERMITTENT, SUSTAINED, AND "BROWN OUT" TYPES OF POWER DISRUPTIONS WERE SIMULATED AND NO MALFUNCTION OF THE STIMULATOR COULD BE INDUCED. IT WAS ATTEMPTED TO INDUCE A FAILURE THROUGH COUPLING OF ELECTROMAGNETIC INTERFERENCE INTO THE ISOLATORS. THIS WAS TRIED BECAUSE OF THE LONG CABLE RUNS FROM THE ISOLATORS TO THE PATIENT THAT ARE UNIQUE TO THIS SITE. NO MALFUNCTION COULD BE INDUCED. ANALYSIS: THE ONLY RECORD AVAILABLE OF THE INCIDENT IS THE ELECTROGRAM RECORDING FROM THE RECORDING SYSTEM THAT WAS IN USE AT THE TIME. ANALYSIS OF THIS RECORDING SHOWS NORMAL OPERATION OF THE STIMULATOR UP TO THE POINT WHERE SEVERAL OF THE TRACES RECORD FULL AMPLITUDE NOISE. PRIOR TO THIS NOISE THERE IS EVIDENCE OF ABNORMAL OPERATION OF THE MIDAS SYSTEM: THE ALPHANUMERIC DATA DISAPPEARS AND THERE ARE GAPS IN THE TRACES. ANOTHER CO ELECTRONICS WAS CONTACTED BUT COULD NOT EXPLAIN THE ABNORMAL OPERATION OF THE RECORDING SYSTEM. SINCE THE STIMULATOR WAS INTERFACED THROUGH THE MIDAS SYSTEM, INFORMATION ON LABELING AND COMPATIBILITY WAS REQUESTED FROM ANOTHER CO. NO INFORMATION HAS BEEN RECEIVED AS OF THIS DATE. ELECTRICAL TESTING REVEALED NO FAILURES OR FAILURE MODES THAT COULD BE INDUCED THROUGH APPLICATION OF ABNORMAL EXTERNAL CONDITIONS. CONCLUSION: THE PROBLEM DESCRIBED BY THE USER PROBABLY WAS NOT DUE TO FAILURE OR MALFUNCTION OF THE STIMULATOR. THERE IS A POSSIBILITY THAT THERE WAS A MALFUNCTION IN THE RECORDING SYSTEM OR IN THE INTERFACE BETWEEN THE STIMULATOR AND THE PATIENT (THROUGH THE RECORDING SYSTEM) BUT THERE IS NOT ENOUGH INFORMATION TO DETERMINE WHAT THIS MALFUNCTION MIGHT HAVE BEEN.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENTS THEMSELVES. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. CO WAS UNABLE TO REVIEW THE PRODUCT'S LOT HISTORIES SINCE THE LOT NUMBERS WERE UNAVAILABLE FROM THE DOCTOR'S OFFICE.
THE PHYSICIAN APPLIED A FALLOPIAN TUBE CLIP TO THE PT'S TUBE WITH NO PROBLEM, BUT THE APPLICATOR WOULD NOT RELEASE THE CLIP. SOME MANIPULATION OF THE APPLICATOR WAS NECESSARY TO FREE THE CLIP. NO PT COMPLICATIONS WERE REPORTED. ANOTHER APPLICATOR WAS USED TO COMPLETE THE CASE.
DATA FOR SECTION F WAS FILLED IN BY THIS U.S. AGENT OF A FOREIGN MFR. EVAL SUMMARY: THE TIP OF THE INNER SHAFT IS BENT DOWNWARD AND THE INNER SHAFT, ITSELF, IS BENT. THERE WAS LOOSENESS OF THE PROXIMAL CONTROL ASSEMBLY FOUND. THE DEVICE HAS RECEIVED POOR CARE AND MAINTENANCE ON THE PART OF THE USER.
HAPTIC BROKE WHILE INSERTION. PER INFORMATION FROM PHYSICIAN, THERE WAS NO TRAUMA TO PT.
DR. REPORTED THAT AN IMPLANT FAILED DUE TO LARGE BONY DEFECT AROUND THE IMPLANT.
DISCONNECTION ON ELECTRODE CABLE AT 6051. NO ELECTRICAL SIGNAL IS AVAILABLE FROM ELECTRODE. ANALYSIS DETERMINED: UNIT MALFUNCTIONED DUE TO BROKEN DISTAL WIRE. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED. REMEDIAL ACTION TAKEN: MANUFACTURING AND QUALITY ASSURANCE PERSONNEL HAVE BEEN NOTIFIED.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT ID NOT CONTAIN STAPLES. THE SURGEON APPLIED MANUAL SUTURE TO COMPLETE THE POCEDURE. THE HOSP HAS STATED THAT THE PT EXPIRED. THE SURGEON STATED THAT THE DEVICE MALFUNCTION IS NOT THE CAUSE OF DEATH.
ON OUR ORIGINAL SUBMISSION OF THIS EVENT ON 11/8/96 B-1 WAS CHECKED AS "ADVERSE EVENT" AND B-2 WAS CHECKED AS "DEATH". WE HAVE INFORMATION FROM THE HEALTHCARE PROFESSIONAL STATING THE PATIENT'S DEATH WAS UNRELATED TO THE DEVICE MALFUNCTION. THEREFORE, THE BOX IN B-1 SHOULD BE CHECKED AS "PRODUCT PROBLEM" AND NO BOXES SHOULD BE CHECKED IN B-2. IN ADDITION, THE EVENT SHOULD BE CHECKED AS A "MALFUNCTION" IN H-1.
X-TUBE ASSM 17" X 18". DEALER RECLAIMS X-TUBE BROKE.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITEED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WHILE PERFORMING AN INCOMING EVALUATION OF THE DEVICE, THE VOLUMES WERE FOUND TO BE OUT OF SPEC. CO'S SVC TECH INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
CODE OOO: CUP SEAL. BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
DR. REPORTED THAT DURING ROUTINE CHECK-UP HE NOTICED THAT THE IMPLANT WAS MOBILE. DR. ELECTED TO REMOVE THE IMPLANT. PT IS REPORTEDLY FINE.
REPORT OF ALLEGED "SINGLE TONE ALARM, ALL LEDS ON, STOP CYCLE. NOT IN PT USE. NO PT HARM."
LABELING- #1738. EVAL SUMMARY: TESTING BT MFR FOUND UNIT STOPPED CYCLING, WITH ALL LEDS AND CONSTANT SINGLE TONE AUDIBLE ALARM WHEN CONTROL DOOR SLAMMED SHUT, AS REPORTED BY CUSTOMER, DUE TO AN INTERMITTENT ELECTRICAL CONNECTION.
IT WAS REPORTED THE PROXIMAL RADIOPAQUE MARKER MOVED DOWN THE CATHETER SHAFT DURING A GRAFT LYSING PROCEDURE. THE CATHETER WAS REMOVED AND A SECOND UNIT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. CO'S FOLLOW UP INDICATED THAT RESISTANCE WAS ENCOUNTERED DURING THIS PROCEDURE AND THE UNIT MAY HAVE BECOME SNAGGED ON CALCIFICATION.THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THE MANUFACTURER. THE ENGINEERING EVALUATION INDICATED THE CATHETER WAS SCRATCHED AND THE SHAFT APPEARED SLIGHTLY STRETCHED. MICROSCOPIC EXAMINATION REVEALED SUFFICIENT ADHESIVE RESIDUE REMAINING AT THE PROXIMAL SWAGE LOCATION OF THE SHAFT.CO'S FOLLOW UP INDICATED THE CATHETER WAS USED TO LYSE A GRAFT. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF A GRAFT MAY CONTRIBUTE TO DIFFICULT ACCESS. ALSO, IT WAS INDICATED, RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE. SCRATCHES WERE NOTED ON THE CATHETER SURFACE WHICH IS INDICATIVE OF CONTACT WITH A SHARP EXTERNAL SOURCE. THEREFORE, THE CO. BELIEVES THE OCCLUDED GRAFT, AS WELL AS CONTINUAL EXERTION AGAINST RESISTANCE, CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE.CO'S DIRECTIONS FOR USE STATE: "DO NOT ADVANCE IF RESISTANCE IS MET WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKING THE NECESSARY REMEDIAL ACTION."
F 10. #2203-OTHER/RADIOPAQUE MARKER MOVED
X-TUBE ASSM 17" X 16". DEALER CLAIMS X-TUBE BROKE AT CTR BOLT.
A LARYNGOSCOPE HANDLE AND BLADE ARE UTILIZED DURING THE INTUBATION PROCESS IN ORDER TO VISUALUZE THE PT'S VOCAL CORDS AND TO ALLOW PROPER PLACEMENT OF AN ENDOTRACHEAL TUBE OT OTHER AIRWAY MANAGEMENT DEVICES. THIS REPORTED EVENT INVOLVES THE DISPOSABLE BLADE ALLEGEDLY BREAKING DURING AN INTUBATION ATTEMPT, ALLEGEDLY CAUSING THE PT'S TOOTH TO BREAK AND TO ALSO DELAY THE INTUBATION PROCESS. CO'S VISUAL EXAMINATION OF THE RETURNED SAMPLES SHOWED NO UNUSUAL INHERENT MOLDING FLAWS. FURTHER EXAMINATION OF THE FRACTURED BLADE SECTIONS, UNDER HIGH MAGNIFICATION, INDICATES THAT THE FAILURE IS TYPICAL OF CO'S INTERNAL DESTRUCTIVE STRENGTH TESTING RESULTS AND THE EXPECTED FAILURE MODE WHEN STRESSED BEYOND THE BLADES' PREDETERMINED LIMITS FUEING AN INTUBATION ATTEMPT. EACH MFG LOT NUMBER OF BLADES ARE DESTRUCTIVELY TESTED IN A STATISTICAL MANNER TO DETERMINE THEIR STRENGTH. ACTUAL RESULTS OF TESTING FOR THIS LOT TO BE ALMOST 57 POUNDS WITH A STANDARD DEVIATION OF 1.6 POUNDS, WHICH IS MORE THAN IS USUALLY REQUIRED FOR DIFFICULT INTUBATIONS (22 1/2 POUNDS AS REFERENCED IN ANESTHESIOLOGY -65:107, 1986). IT WAS ALSO NOTED THAT TEETH MARKS WERE EVIDENT ALONG A SIGNIFICANT LENGTH OF THE BLADES SURFACE. THIS LOCATION ACTED AS THE FULCRUM POINT FOR ALL FORCE APPLIED BY THE CAREGIVER. AN ADD'L UNBROKEN RETURNED BLADE ALSO HAD SOME TEETH MARKS, OF A LESSER DEGREE, IN THE SAME LOCATION. THIS BLADE WAS CONNECTED TO HE HANDLE IN USE DURING THE INCIDENT AND FOUND TO FIT WELL AND OPERATED AS INTENDED. CO HAS CONFIRMED THE BLADE BREAKAGE AND HAVE DETERMINED THE CAUSE TO BE FROM OVERSTRESSING THE BLADE DURING THE INTUBATION PROCESS, WHICH PROBABLY CAUSED THE PT'S TOOTH TO BREAK. THE BREAKING OF THE PT'S TOOTH IS A FURTHER INDICATION THAT THE BLADE WAS STRONG ENOUGH TO ALLOW THE TRANSMISSION OF FORCE REQUIRED TO BREAK A TOOTH. HAD THE STRENGTH OF THE BLADE IN QUESTION NOT BEEN UP TO SPECIFICATION, THE BLADE COULD HAVE FRACTURED BEFORE THE PT'S TOOTH BROKE.
REPORTER IMMEDIATELY NOTED CORNEAL SHRINKAGE (BURN) AT BEGINNING OF PHACOEMULSIFICATION. THE HANDPIECE WAS CHANGED TO COMPLETE THE CASE. SEVERAL SUTURES WERE REQUIRED TO CLOSE THE WOUND.
H-10: A COMPANY SVC REP CHECKED THE SYSTEM AND HANDPIECE IUHP053293 AND FOUND BOTH TO MEET THEIR PERFORMANCE SPECS. H-11: SECTION F INFO WAS SUPPLIED BY USER FACILITY. F-10: 1757 - LABELED. THIS REPORT WAS MAILED IN TO FDA ON: 11/8/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
DR. REPORTED THAT AN IMPLANT FAILED DUE TO INSUFFICIENT BONE. DR. GRAFTED THE SITE. PT IS REPORTEDLY FINE.
THE DEVICE WAS USED DURING AN UNSPECIFIED LAPAROSCOPIC PROCEDURE. REPORTEDLY, THE INSTRUMENT JAMMED. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/8/96-MEDWATCH REPORT NO TRECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
X-TUBE ASSM 20" X 16". DEALER ALLEGES X-TUBE BROKE AT THE CTR BOLT.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITEED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRM, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE SVC REPORT SHOWS THAT WHILE PERFORMING AN INCOMING EVALUATION, THE DEVICE FAILED TO CYCLE ON AC POWER AND SWITCH TO INTERNAL BATTERY WITHIN SPEC. THE CO'S SVC TECH INSPECTED THE DEVICE AND NOTED THAT THE INTERNAL BATTERY WAS MISSING. THE SVC TECH REPLACED THE INTERNAL BATTERY PACK. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
DR. REPORTED THAT AN IMPLANT FAILED TO INTEGRATE DUE TO INFECTION. PT IS REPORTEDLY FINE.
DURING SERVICE OF PRODUCT A POTENTIAL NO LOW PRESSURE ALARM CONDITION WAS FOUND DUE TO POWER SURGE TO UNIT. CUSTOMER RETURNED UNIT TO MFR DUE TO POWER SURGE REQUESTING UNIT BE CHECKED OUT.
H.6.) 100 POTENTIAL NO LOW PRESSURE ALARM DUE TO POWER SURGE TO UNIT. LABELING-#1738.
DISCONNECTION ON THERMISTOR CABLE AT 407-1HSK. COC ASHOWS BLOOD TEMPERATURE IMMEDIATELY AFTER CATHETER WAS CONNECTED, BUT IT SHOWED "CATHETER FAULT" A COUPLE OF MINUTES LATER. ANALYSIS DETERMINED: THERMISTOR WIRE BECAME DETACHED FROM LEADS WITHIN THERMISTOR CASING CAUSING AN UNSTABLE READING. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED. REMEDIAL ACTION IS NECESSARY.
UPON CANNULATION, THE CANNULA WENT PART WAY INTO THE HUB. THE TIP OF THE NEEDLE ENTERED GRAFT AND SHORTLY THEREAFTER FELL OUT.
PERFORMED VISUAL INSPECTION OF 50 RETNETION SAMPLES FOR GLUE SEPARATIONS AND CANNULA WING BOND TEST ON 25 RETENTIONS. ALL SAMPLES TESTED WERE WITHIN SPECIFICATION AND HAD FIVE VISIBLE RINGS OF EPOXY ON CANNULA.
METHOD (86): PART NOT RETURNED. LOT NUMBER NA.
DURING A CODE SITUATION THE CATHETER WAS BEING SUTURED IN PLACE WHEN IT SEPARATED AT THE HUB. THE CATHETER BODY EMBOLIZED, AND REMAINED IN THE PT. THE PT DIED OF CAUSES UNRELATED TO THIS INCIDENT.
THE SAMPLE WAS RETURNED FOR EVAL. EXAM SHOWED THAT THE CATHETER WAS CUT JUST DISTAL TO THE CATHETER JUNCTION HUB. THE CAUSE OF THE SEPARATION WAS DUE TO A SHARP OBJECT; POSSIBLY A SCALPEL CUT DURING THE SUTURING OPERATION.
X-TUBE ASSEMBLY 16" X 16". DEALER ALLEGES X-TUBE BROKE WHILE USER WAS TRANSFERRING INTO CHAIR.
HIGH STRESS FACTOR AT CTR AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITEED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OR THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CATHETER WAS BEING UTILIZED FOR A DIAGNOSTIC CARDIOLOGY PROCEDURE WHEN IT KINKED AT THE LEADING END DURING AN ATTEMPT TO SELECT THE RIGHT CORONARY ARTERY. THERE WAS NO REPORTED INJURY TO THE PT. 4.0 CATHETER FROM THIS PACK WAS IN USE.
TESTS RESULTS: THE RETURNED CATHETER WAS EVALUATED AND FOUND TO MEET BOTH THE VALIDATION AND SPECIFICATION REQUIREMENTS FOR CATHETERS OF THIS TYPE. THE PERFORMA LINE OF CATHETERS ARE ROBUST DEVICES BUT CAN BE KINKED UNDER CERTAIN CONDITIONS. HOWEVER, THE CAUSE FOR THE KINK IN THIS DEVICE COULD NOT BE DETERMINED. THE ADDITIONAL INFO PROVIDED IN SECTION F WAS SUPPLIED BY MALLINCKRODT INC.
DURING SERVICE OF PRODUCT A POTENTIAL NO LOW PRESSURE ALARM CONDITION WAS FOUND DUE TO TRANSDUCER BEING OUT OF CALIBRATION. REPLACED TRANSDUCER.
LAB TECH RETURNED A BROKE ABUTMENT. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS COULD NOT BE TAKEN DUE TO THE CONDITION OF THE COMPONENT. A REVIEW OF THE PRODUCT'S LOT HISTORY COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR'S OFFICE.
THE SVC REPORT SHOWS THE LEAK TEST WAS OUT OF SPEC DURING PERFORMANCE OF AN INCOMING EVALUATION. THE CO'S SVC TECH INSPECTED THE DEVICE AND REPLACED THE SAFETY VALVE SPRING. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
A DUAL LUMEN CATHETER WAS RETURNED FOR EVALUATION. THE CATHETER HAD BEEN SEVERED INTO TWO PIECES, BUT APPEARED TO BE COMPLETE. THIS WAS APPARENTLY DONE AFTER EXPLANTATION TO RENDER THE DEVICE NON-FUNCTIONAL. THE CATHETER WAS SEVERED JUST DISTAL TO THE 10CM DEPTH MARK (2 DOTS). THE DISTAL SEGMENT INCLUDED THE VALVES AND THE DISTAL TIP. THERE APPEARED TO BE GRIP MARKS FROM A SERRATED JAWED INSTRUMENT ON THE DISTAL SEGMENT'S OUTER DIAMETER NEAR THE CUT END. THERE WAS A BLOOD RESIDUE CLOT INSIDE THE LUMEN BEHIND THE DISTAL VALVE. THE DISTAL SEGMENT MEASURED 20.95" LONG. THE PROXIMAL SEGMENT INCLUDED TWO CUFFS, THE BIFFURCATION, THE PROXIMAL AND DISTAL LUMEN LEGS WITH BLUNT HUB CONNECTORS INSERTED INTO THEIR PROPER LUMENS. THE PROXIMAL SEGMENT MEASURED 3.8" LONG. BOTH LUMENS APPEARED TO BE CLEAR WITH SOME CLEAR CRYSTALLINE RESIDUE SEEN INTERMITTENTLY ALONG THE LUMENS. NOTES IN THE FILE INDICATED THAT EXTRAVASATION WAS NOTICED THROUGH A DYE STUDY. WHEN THE RED (DISTAL) LUMEN WAS FLUSHED, A SMALL AMOUNT OF THE CONTRAST LEAKED BEFORE ENTERING THE VEIN. WHEN THE CONTRAST WAS INFUSED INTO THE WHITE (PROXIMAL) LUMEN, A GREAT DEAL EXTRAVASATED AND DID NOT ENTER THE VEIN. THE CATHETER HAD BEEN IN THE PATIENT SIX DAYS. TACTUAL EXAMINATION OF THE CATHETER TUBING FOUND NO ELASTIC WEAKNESS OR DAMAGE. BOTH LUMENS OF THE PORXIMAL SEGMENT WERE FLUSHED INDEPENDENTLY USING A 12CC SYRINGE FILLED WITH WATER ATTACHED TO EITHER CONNECTOR HUB. BOTH LUMENS FLUSHED FREELY. WITH THE DISTAL END OF THE SEGMENT OCCLUDED WITH FINGER PRESSURE, BOTH LUMENS WERE PRESSURIZED AND TESTED INDIVIDUALLY FOR LEAKS. THE TUBING BULGED, BUT NO LEAKS WERE DETECTED. THIS WAS REPEATED SEVERAL TIMES WHILE MANIPULATING THE TUBING. THE DISTAL CATHETER SEGMENT WAS TESTED IN THE SAME MANNER BY INSERTING A BLUNT CONNECTOR INTO EACH LUMEN. AGAIN, THE LUMENS WERE FOUND TO BE PATIENT AND NO LEAKS WERE DETECTED. THE TUBING BULGED AS THE PRESSURE WAS HELD FOR SEVERAL SECONDS, BUT NO LEAKS WERE SEEN. UNDER MAGNIFICATION, THE SEVERAL ENDS OF THE SEGMENTS APPEARED TO MATCH WHEN MATED. THE SEVERAL PLANE ON BOTH ENDS WAS GLOSSING WITH OPPOSING, CURVED STRIATIONS ACROSS THE SURFACE. THIS IS THE COMMON FINGERPRINT OF A SCISSORS CUT. THE GRIP MARKS ON THE DISTAL SEGMENT WERE LIKELY MADE WITH TOOTHED HEMOSTATS. THE USER PROBABLY GRIPPED THE TUBING HERE TO CUT IT. THERE IS NO OTHER DAMAGE OR DEFORMATION ASSOCIATED WITH THE PARING OF THE CATHETER. NO OTHER DAMAGE THAT WOULD SUGGEST A LEAK IS EVIDENT ON THE BODY OF THE CATHETER. GIVEN THE RELATIVELY SHORT TIME THAT THE CATHETER WAS IN THE BODY, THE FORMATION OF A FIBRIN SHEATH IS NOT PROBABLE. THE EXTRAVASATION SEEN THROUGH THE DYE STUDY IS THEREFORE DIFFICULT TO EXPLAIN. IT MAY HAVE BEEN THE CATHETER WAS NOT LOCATED PROPERLY IN THE VEIN. LEKAGE OF THE CATHETER IS UNCONFIRMED. NO LEAKS WERE MANIFESTED WITH THE RETURNED DEVICE. ASSUMING THAT THE LEAK DID NOT OCCUR AT THE CUT, NO DEFECT WAS FOUND WITH THE DEVICE.
WHILE TUBE WAS IN USE THAT THE BRONCHIAL TUBE PULLED OUT FROM INSERTION POINT.
REAR S/F DAB PAINTED L & R Q2. EALER ALLEGES REAR SIDE FRAMES ARE BROKEN AT THE WELD.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITEED BY CO UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY CO OR THE FDA THAT THE DEVICE, CO, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DR. REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE..
METHOD (86): PART NOT RETURNED. LOT NUMBER NA FROM DR.
DURING SERVICE OF PRODUCT AN INTERMITTENT APNEA ALARM WAS FOUND DUE TO DIODES CR31 AND CR32 AN ANALOG BOARD BEING OUT OF SPECIFICATION. REPLACED CR31 AND CR32.
REPORT OF ALLEGED "VENTILATOR DOESN'T ACTIVATE NURSE CALL SYSTEM THROUGH ANNUNCIATION. NO AUDIBLE ALARM. NO PT HARM."
LABELING_ #1738. TESTING BY MFR FOUND UNIT DOES NOT ACTIVATE (NO AUDIBLE ALARM) NURSES CALL SYSTEM, DUE TO INTEGRATED CIRCUIT U12 ON THE LOGIC BOARD BEING OUT OF SPECIFICATION. REPLACED U12.
PEANUT SPONGE FELL OFF DURING SURGERY. THE PEAUNT WAS RETRIEVED EASILY WITH NO CONSEQUENCE TO THE PT.
THIS IS TO REPORT ADDITIONAL INFO REGARDING THE FINALIZATION OF THE MEDICAL DEVICE REPORT #1049753-1996-10. THE FAILURE MODE SUGGESTED ONE OF THE MOLDED COMPONENTS HAD A WEAK SPOT WHICH MAY HAVE MADE IT MORE VULNERABLE TO CERTAIN SHEER FORCES. OUR PROCESS PARAMETERS FOR MOLDING THIS COMPONENT HAVE BEEN OPTIMIZED TO REDUCE THE CHANCE OF THIS RECURRING. THIS IS THE FIRST REPORTED INCIDENT OF THIS NATURE ON THIS PRODUCT. WE WILL CONTINUE TO TREND.
DR. REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-996-00262.
METHOD (86): PART NOT RETURNED. LOT NUMBER NA FROM DRS.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, SPARKS WERE OBSERVED. THE HOSPITAL HAS REPORTED THAT NO PATIENT INJURY HAS OCCURRED.
9/20/96-MEDWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT.
HOSPITAL REPORTED THAT THIS UNIT DELIVERED 100% OXYGEN REGARDLESS OF THE SETTING OF THIS UNIT. THE BLENDER DID NOT ALARM WHEN THIS OCCURED.
THE REPORTED EVENT WAS CAUSED BY A STICKING BYPASS POPPET VALVE WHICH ALLOWED OXYGEN TO BYPASS DIRECTLY TO THE BLENDER OUTLET. THIS WAS CAUSED BY WATER CONTAMINATION FROM THE HOSP AIR SUPPLY. THE ALARM CAP OF THIS UNIT WAS FOUND TO BE ASSEMBLED BACKWARD. SERVICING OF THIS UNIT IS PERFORMED BY A 3RD PARTY AND NOT THE MFR.
THE CUSTOMER RETURNED THE SYSTEM WITH THE FOLLOWING REPORTED PROBLEMS; LOW FLOWS, LOW PRESSURE, AND LIQUID OXYGEN LEAKS OUT OF THE PRIMARY RELIEF VALVE. DURING FUNCTIONAL TEST, ENOUGH LIQUID OXYGEN LEAKED FROM THE FILL TUBE DUE TO AN IMPROPERLY SEATED FERRULE TO POTENTIALLY CAUSE A SERIOUS INJURY IF THIS EVENT WERE TO RECUR. THIS MALFUNCTION IS CONSISTENT WITH THE RESULT OF THIS MALFUNCTION. CO'S SERVICE TECH ALSO REPORTED THAT THE FLOWS AND SIDE COVER B IS CRACKED. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MANUFACTURING PROCESS PER THE APPROVED MDR. NONE OF THESE FINDING APPEAR TO BE RELATED TO MANUFACTURING PROCESSES, PROCEDURES, OR SPECIFICATION.
THERE WAS AN ANTERIOR CHAMBER COLLAPSE; FELT THAT IT WAS DUE TO UNIT. PT REQUIRED AN ANTERIOR VITRECTOMY.
H-10: A COMPANY SVC REP CHECKED THE SYSTEM AND FOUND IT TO MEET ITS PERFORMANCE SPECS. NO CONSUMABLES WERE SAVED. PT INFO WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE. H-11: SECTION F INFO WAS SUPPLIED BY USER FACILTY. THIS REPORT WAS MAILED IN TO FDA ON: 11/7/96. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
REPORTED THAT THE PENCIL ACTIVATED ITSELF, THE GENERATOR TONE WAS HEARD WHEN THE PENCIL WAS IN THE HOLSTER. NO PT INJURY.
9/19/96 THE HOSPITAL WAS CONTACTED AND NO FURTHER INFO IS AVAILABLE. THE DEVICE IN QUESTION WAS TESTED ON A SYSTEM 6000 ELECTROSURGICAL UNIT. THE PENCIL DID NOT ACTIVATE WHEN FIRST PLUGGED INTO THE UNIT. THE CUT AND COAG FUNCTIONS TESTED WITHIN SPECIFICATION. NO EVIDENCE OF PRODUCT DEFECT WAS FOUND.
THE SVC REPORT SHOWS THAT THE NO PRESSURE ALARM DID NOT ACTIVATE WITHIN SPEC. THE SVC TECH INSPECTED THE DEVICE AND ADJUSTED THE NO PRESSURE ALARM CIRCUIT TO SPEC. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BADED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FRQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE.
INSERT DID NOT SEAT PROPERLY INTO TIBIAL TRAY.
THE VOLUMES WERE FLUCTUATING WITH EACH BREATH. THE CO'S SVC TECH VERIFIED THAT THE VOLUMES AND PRESSURES WERE OUT OF SPEC. THE CSE INSPECTED THE DEVICE AND REPLACED THE CUP SEAL. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
STEM EXTENSION COMPONENT APPEARS TO BE DISASSOCIATED FROM THE TOTAL KNEE TIBIA PROSTHESIS ON THE PT'S POSTOPERATIVE X-RAY. SURGEON ALLEGEDLY DID NOT FOLLOW THE RECOMMENDED INSTRUCTIONS FOR ASSEMBLING THE DEVICE. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HERE OF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OR DEPUY INC OR ITS AFFILIATES.
UNIT FAILED DURING A WIDE INCISION MELANOMA OF THE BACK. THERE WAS NO HARM TO THE PT. THE PENCIL HAS BEEN DETERMINED TO BE THE PROBLEM.
INVESTIGATION OF THE COMPLAINT HAS BEEN COMPLETED. THE ORIGINAL COMPLAINT STATING THAT "UNIT FAILED DURING A PROCEDURE. NURSE HAD TO GO GET ANOTHER ONE." WAS RECEIVED 10/8/96. THE DEVICE WAS NOT RETURNED FOR EVAL HOWEVER ON 10/15/96 IN A FOLLOW-UP PHONE CALL THAT THE UNIT HAD BEEN OPERATING PROPERLY AND THAT THE PENCIL WAS THE PROBLEM ALL ALONG. THE PENCIL LOT LISTED WAS ORIGINALLY SHIPPED WITH THE ESU AND WAS PRODUCED 8/95. A MALFUNCTION MDR HAS BEEN FILED WITH THE FDA ON THIS INCIDENT. EVAL OF THE RETURNED DEVICE WAS NOT POSSIBLE HOWEVER THE PENCIL FAILURE DESCRIBED IS SUSPECTED TO BE AN OPEN IN THE RF LEAD PREVENTING OUTPUT. WHEN TESTING WITH A LIKE DEVICE, THE RF LEAD BREAKAGE WAS IDENTIFIED AS A POSSIBLE PROBLEM. THIS PROBLEM OF WIRE BREAKAGE HAS BEEN CORRECTED IN A REVISED VERSION OF THE CABLE. UPON RETURN OF THE DEVICE IN QUESTION, A REPLACEMENT PENCIL, WHICH IS CURRENTLY AVAILABLE WITH THE IMPROVED CABLE, WILL BE PROVIDED AND THE RETURNED DEVICE SCRAPPED. CO REGRETS THE DEFECTIVE CABLE MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT, HOWEVER SINCE THE DEVICE WAS NOT RETURNED NO ABSOLUTE CAUSE WAS DETERMINED. THESE DEVICES ARE 100% TESTED AND VISUALLY EXAMINED FOR SEVERAL DETAILS DURING PRODUCTION AND ANY FAILURES DETECTED WOULD BE CAUSE FOR REJECTION.
WHILE PERFORMING AN INCOMING EVALUATION OF THE DEVICE, THE LEAK TEST WAS FOUND TO BE OUT OF SPEC. CO'S SVC TECH INSPECTED THE DEVICE AND REPLACED THE VALVE CUP O-RINGS. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
REPORTER ENCOUNTERED LOW VACUUM DURING PROCEDURE AND POSSIBLE PT INJURY. FOLLOW-UP REPORT STATED THE DR INDICATED THAT PT INJURY WAS DUE TO DEVICE.
H-10: A CO SVC REP CHECKED THE SYSTEM AND FOUND IT TO MEET ITS PERFORMANCE SPECS. DETERMINED THAT PROBLEM WAS DUE TO IMPROPERLY SEATED CASSETTE. PROVIDED IN-SERVICE FOR STAFF & ATTENDED SURGERY WITH DR. DR REFUSED TO PROVIDE ANY INFO ABOUT THE PT, OR TYPE OF INJURY. H-11: SECTION F INFO WAS SUPPLIED BY USER FACILITY. THIS REPORT WAS MAILED IN TO FDA ON: 11/8/96. DISCLAIMER: THIS INFOIS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIED, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
LEAK IN AREA THAT CONNECTS TO BLOOD BAG.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT STAPLE AND WAS DIFFICULT TO REMOVE. THE SURGEON RESECTED THE APPLICATION SITE AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
11/8/96-MEDWATCH REPORT NOT RECEIVED  BY MFR. SUBMISSION OF INITAL TO FDA  BY MFG.
IMPLANT DID NOT INTEGRATE AND "POPPED OUT". ONE PERSON AFFECTED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER NO NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
THE DEVICE WAS USED DURING A MASTECTOMY PROCEDURE. REPORTEDLY, CLIPS FELL OUT OF THE INSTRUMENT UNFORMED AND THE INSTRUMENT DID NOT FIRE. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.
REPORTER STATED THAT CALLER FROM ACCOUNT REPORTED THAT THE UNIT HAD INACCURATELY FILLED A FINAL CONTAINER ON THE BASIS OF REFRACTIVE INDEX READINGS. THE ACCOUNT REJECTS SOLUTIONS IN WHICH THE REFRACTIVE INDEX DIFFERS BY MORE THAN 1 UNIT FROM THAT CALCULATED BY THE UNIT. THIS IS AN INSTITUTION SPECIFIC SPEC, NOT A MFR'S SPEC. THE PROGRAMMED VOLUMES AND VOLUMED DELIVERED DISPLAYS ON THE UNIT WERE IDENTICAL, SO THE UNIT WAS OPERATING WITHIN THE MFR'S SPECS. NO PT INVOLVEMENT. THE UNIT WAS SWAPPED OUT 10/9/96.
EVALUTION: THE UNIT WAS VERY DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
THE DIRECTOR OF SURGICAL SERVICES WAS PRESSING ON COAG AND REPORTED THAT HE SUSTAINED A BURN ON HIS FINGER. HE SAID THAT THE SWITCH BURNED A HOLE IN HIS GLOVE. NEOSPORIN WAS APPLIED. THE BURN WAS VERY MINOR. THE HOSPITAL WILL NOT FILE A MEDWATCH REPORT.
INVESTIGATION OF THE ABOVE REFERENCED COMPLAINT HAS BEEN COMPLETED. THE COMPAINT ON THE DEVICE STATING THAT "USER WAS PRESSING ON COAG AND SUSTAINED A BURN ON HIS FINGER. THE SWITCH BURNED A HOLE IN HIS GLOVE. NEOSPORIN WAS USED FOR TREATMENT." WAS RECEIVED 9/10/96 AND A MALFUNCTION MDR WAS FILED BASED ON THE INFO PROVIDED THAT THE INJURY THAT OCCURRED WAS NOT SERIOUS HOWEVER RECURRENCE COULD CAUSE A SERIOUS INJURY. THE DEVICE WAS RETURNED FOR EVAL AND RECEIVED BY CO ON 9/13/96. THE DEVICE WAS EXAMINED VISUALLY AND NO EVIDENCE OF BURN MARKS OR PROBLEMS OF ANY TYPE WAS OBSERVED, NONE ON OR NEAR THE COAG BURTTON WHERE THE OPERATOR'S FINGER WAS BURNED. THE PENCIL WHEN TESTED AT CO WAS OPERATING NORMALLY AND FROM THE DESCRIPTION GIVEN OPERATED NORMALLY AT THE TIME OF THE EVENT. WHEN THE PENCIL BUTTON IS DEPRESSED, THE COAG BUTTON PUSHES AGAINST A SILICONE TUBE COVERING THE COAG SWITCH WIRE, THIS WIRE MAKES CONTACT WITH THE RF LEAD, TO ACTIVATE THE ESU. UPON ACTIVATION THE RF POTENTIAL IS AVAILABLE ON THE SWITCH WIRE, AS WELL AS THE ACTIVE ELECTRODE. WHEN EXAMINED UNDER 2.5X MAGNIFICATION THE INSULATION SYSTEM PROTECTING THE OPERATOR CONSISTING OF THE PLASTIC BUTTON AND THE SILICONE TUBE WERE INTACT. NO EVIDENCE OF A CARBON TRAIL OR DETERIORATION OF THE PLASTIC WAS OBSERVED, THUS AN RF CURRENT PATH FROM THE SWITCH WIRE TO THE BUTTON WAS UNLIKELY. SINCE THE RF POTENTIAL EXISTS ALONG THE EXPOSED METAL PORTION OF THE ELECTRODE SHAFT, A CURRENT PATHWAY COULD BE ESTABLISHED THROUGH ANY CONDUCTIVE FLUIDS WHICH MAY EXIST ON THE EXTERNAL SURFACE OF THE PENCIL THROUGH THE OPERATOR AND BACK TO THE PT. ALTHOUGH IT CANNOT BE DETERMINED EXACTLY HOW THE RF PATH WAS ESTABLISHED IT IS REASONABLE TO CONCLUDE THAT THE PATH ORIGINATED FROM THE ACTIVE ELECTRODE. THE PENCIL WAS NOT FOUND TO HAVE ANY MANUFACTURING OR MATERIAL DEFECTS WHICH MIGHT SUGGEST HOW THE INCIDENT WOULD HAVE OCCURRED. CO REGRETS THAT THE INCIDENT OCCURRED, HOWEVER NO DEVICE FAILURE WAS INDICATED. THE USER IS REMINDED THAT GOOD ELECTROSURGERY PRACTICE INCLUDES THAT THE ACTIVE ELECTRODE SHOULD BE IN CONTACT WITH METAL HEMOSTAT CLAMPS WHEN ACTIVATED TO ELIMINATE ARCING AND REDUCE THE POTENTIAL FOR UNINTENDED RF PATHWAYS BEING ESTABLISHED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND THAT NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
THE DEVICE WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. THE SAFETY SHIELD DID NOT FUNCTION PROPERLY AFTER INSERTING INTO THE PELVIC CAVITY. SUBSEQUENTLY, A HEMATOMA FORMED ON THE POSTERIOR ABDOMINAL WALL. THE SURGEON CONVERTED TO AN OPEN PROCEDURE TO CORRECT THIS  CONDITION.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT JAMMED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL REPORTED NO PATIENT INJURY OCCURRED.
12/13/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D7 AND D8. CORRECTIVE DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
DISLOCATION OF HIP PROSTHESIS. SURGERY REQUIRED-OPEN REDUCTION OF THE LEFT HIP.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVLOVED, HAS BEEN RECEIVED. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
CUSTOMER CLAIMS INTERMITTENT CONDITION OF UNIT FOLDING. NO INJURIES REPORTED.
SURGEON WAS PLACING A SCREW ANOTHER CO ON RIGHT ACL WITH A SMALL FRAGMENT  SCREWDRIVER WHEN TIP (1MM) OF THE SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW. SURGEON WAS UNABLE TO RETRIEVE THE PIECE FROM THE HEAD OF THE SCREW.
SYNTHES IS SUBMITTING THIS REPORT PERSUANT TO THE PROVISION S OF 21 CFR, PART 803. THEIS REPORT MAY BE BASED UPON INFO WHICH SYNTHES HAS NOT BEEN ABEL TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR IT'S IMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. S
THIS IS THE SECOND OF SEVEN REPORTS OF ENDOPHTHALMITIS RECEIVED FROM AN OPHTHALMOLOGIST ASSOCIATED WITH POST OPERATIVE CATARACT EXTRACTION AND POSTERIOR INTRAOCULAR LENS IMPLANT. IN THIS CASE, SURGERY WAS DONE ON 9/25/95. A MODEL 809F/+22.5(D) WAS IMPLANTED INTO THE LEFT EYE POST CATARACT EXTRACTION. ON 11/9/95, FINDINGS OF ENDOPHTHALMITIS WERE NOTED ON EXAM AND THE PT WAS REFERRED TO A SPECIALIST. A VITRECTOMY WAS PERFORMED ON 11/10/95. THE CULTURE WAS POSITIVE FOR STAPH EPIDERMIDIS. A HOSP INVESTIGATION IS IN PROGRESS. THE BATCH RECORDS, INCLUDING RECORDS IN STERILIZATION PROCESS AND STERILIZATION TESTS WERE REVIEWED AND NO DEVIATIONS FOUND. ADD'L INFO FOR THIS REPORT IS BEING REQUESTED FROM THE PHYSICIAN AS WELL AS THE REPORT OF THE HOSP INVESTIGATION. THIS PHYSICIAN REPORTED SEVEN CASES TO CO AND ONE REPORT TO ANOTHER CO OF ENDOPHTHALMITIS ASSOCIATED WITH LENS IMPLANTS THAT OCCURRED FORM THE TIME PERIOD 11/17/94 TO 9/19/96.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH TH EBEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
CUSTOMER CLAIMS UNIT FOLDED WHILE TRANSPORTING A PT. NO INJURIES REPORTED.
RE H-6: CUSTOMER CALLED INDEPENDENT SERVICE AGENT. DEVICE NOT AVAILABLE FOR CO'S REVIEW.
THE DEVICE IN QUESTION WAS TESTED ON A SYSTEM 6000 ELECTROSURGICAL UNIT. THE CUT, COAG AND ABC INITIATED FUNCTIONS TESTED WITHIN SPEC. NO EVIDENCE OF PRODUCT DEFECT WAS FOUND.
PHYSICIAN REC'D DEVICE WITH OVERFILL SPECS MISLABELED. NO ADDITIONAL INFO, IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY; MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I(B)(3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVAL ATTACHED HERETO.
BASED ON THE LIMITED INFO RECEIVED THROUGH THE INTERNATIONAL DISTRIBUTOR, IMPLANTATION OF THIS DEVICE WAS ABANDONED DUE TO "RUPTURE" OF THE CORPUS CAVERNOSM.
ACCORIDNG TO THE AVAILABLE INFO THIS PENILE PROSTHESIS WAS TO BE IMPLANTED ON 4/7/96. DURING SURGERY IT WAS NOTED THAT THE 'CORPUS CAVERNOSUM (HAD) RUPTURED," THEREFORE THE DEVICE WAS REMOVED AND NOT IMPLANTED. REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. BECAUSE QA'S EXAM OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF A RUPTURE OF THE CORPORA, QA DID NOT PERFORM A MICROSCOPIC EXAM. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE REPORT OF SUCH AS THE REASON FOR REMOVAL.
THE UNIT WAS MAKING A WHISTLING NOISE. THE CO'S SVC TECH (ST) VERIFIED THE NOISE AND THAT THE VOLUME, LEAK AND OUTLET VALVE TESTS WERE OUT OF SPEC. THE ST INSPECTED THE DEVICE AND REPLACED THE MOTOR, GEARBOX AND INLET AND OUTLET CHECK VALVES. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
A REVIEW OF THE REPORTED DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANTS WERE EVALUATED AND FOUND TO BE TWO DIFFERENT SIZES; 3.75X13 AND 3.75X15, BOTH DEVICES. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
CUSTOMER CLAIMS THERMOMETER READING IS STUCK AT 10-DEGREES. NO INJURIES REPORTED.
RE H-6: COMPONENT HAS NOT BET BEEN RETURNED TO CO.
THE SVC REPORT SHOWS THAT WHILE PERFORMING AN UNRELATED SVC ON THE DEVICE, THE CO SVC TECH (ST) FOUND THE LEAK TEST TO BE OUT OF SPEC. THE ST INSPECTED THE DEVICE AND ADJUSTED THE PISTON GUIDES. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
CO WAS ADVISED ON 11/1/96, THAT PT HAD BEEN INVOLVED IN A CAR ACCIDENT, SOMTIME IN 6/96. SUBSEQUENT X-RAYS SHOW THE HIP IMPLANT TO HAVE A TRANSVERSE FRACTURE, WHICH WILL REQUIRE REVISIONL THIS IS A FLUKE OCCURRENCE BUT REPORTABLE NEVERTHELESS.
THE DEVICE WILL BE ANALYZED IF IT IS AVAILABLE FOLLOWING REVISION. IN VIEW OF THE CAUSE OF BREAKAGE NO CORRECTIVE ACTION IS ANTICIPATED.
THIS IS INE OF THE SEVEN REPORTS OF ENDOPHTHALMITIS RECEIVED FROM AN OPHTHALMOLOGIST ASSOCIATED WITH POST OPERATIVE CATARACT EXTRACTION WITH AN POSTERIOR INTRAOCULAR LENS IMPLANT. THIS WOMAN HAD SURGERY FOR CATARACT EXTRACTION WITH IMPLANTATION OF PC IOL MODEL 809F/+22.5(D) OF THE LEFT EYE ON 9/19/96. ON 9/24/96, HER EYE WAS MATTED SHUT AND TEARING. A DIAGNOSIS OF ENDOPHTHALMITIS WAS MADE AND SHE WAS REFERRED TO A RETINAL SPECIALIST. A CULTURE REVEALED STAPH LUGDENESIS AND SHE WAS TREATED WITH ANTIBIOTICS. AS OF 10/10/96, HER VISION WAS 20/40 AND A VITREOUS HEMORRHAGE WAS NOTED. THE OPHTHALMOLOGIST HAD EIGHT OCCURRENCES OF ENDOPHTHALMITIS, SEVEN ASSOCIATED WITH THE LENSES MFG BY CO AND ONE WITH ANOTHER BRAND LENS FROM 11/17/94 TO 9/19/96. CURRENTLY, A HOSP INVESTIGATION IS IN PROGRESS. A REVIEW OF BATCH RECORDS FOR THIS LENS WHICH INCLUDED STERILIZATION PROCESS AND STERILIZATION TESTS REVEALED NO DEVIATIONS. ADD'L INFO IS BEING  SOUGHT AS WELL AS A REPORT OF THE HOSP INVESTIGATION.
PT WITH DIAGNOSOS OF BLADDER CANCER HAD UTERO-ILIAL ANASTOMOTIC STRICTURE. DURING NEPROSTOMOGRAM, AN 8MM BALLOON WAS PLACED TO PERFORM DILATION AND INFLATED FOR 10 MINUTES. AFTER INFLATION, URETERAL RUPTURE WAS DOCUMENTED WHEN FOLLOW UP NEPHROSTOMOGRAM WAS DONE. A NEPHRO-URETERAL STENT WAS PLACED TO EXTERNAL DRAINAGE. PT WAS DISCHARGED FROM THE HOSP AND WAS TO BE FOLLOWED IN THE CLINIC.
THE SVC REPORT SHOWS THAT WHILE PERFORMING AN INCOMING EVALUATION OF THE DEVICE, THE HIGH PRESSURE ALARM WOULD NOT ACTIVATE. CO'S SVC TECH INSPECTED THE DEVICE AND ADJUSTED THE HIGH PRESSURE ALARM CIRCUIT. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT CUT BUT DID NOT STAPLE. THE SURGEON APPLIED ANOTHER DEVICE AND RESECTED THE ORIGINAL APPLICATION SITE.
11/8/96-MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF NITIAL REPORT TO FDA. CO FOREIGN SUBSIDIARY WAS INFORMED OF THIS IN 9/96; HOWEVER, CORPORATE WAS NOT INFORMED UNTIL OCT 14,1996. CO FOREIGN SUBSIDIARY WILL BE RE-INSTRUCTED REGARDING THE STATUORY REPORTING REQUIREMENTS OF THE MDR REGULATION.
THE SVC REPORT SHOWS THAT WHILE PERFORMING AN INCOMING EVALUATION OF THE DEVICE, THE VOLUMES WERE FOUND TO BE OUT OF SPEC. CO'S SVC TECH INSPECTED THE DEVICE AND REPLACED THE SAFETY VALVE SPRING. THE UNIT PASSED EXTENDED TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
CUSTOMER REPORTED EXPERIENCING LEAKAGE AT THE CASSETTE DURING USAGE. THE PT HAD 400MG OF CIPRO SOLUTION HUNG AT 1545 HOURS, ON 9/3 OR PRIOR. THEY DID NOT NOTICE LEAKAGE AT THAT TIME, BUT CAN NOT STATE EXACTLY WHEN THE LEAKAGE OCCURRED. NO PT INJURY WAS REPORTED. NO FURTHER INFO IS AVAILABLE.
SECTION 10A AND B. AS A RESULT OF REGULATION CHANGES EFFECTIVE 7/31/96, THIS SECTION NO LONGER APPLIES. A,B.6., B.7., H.4., AND H.8. UNKNOWN-ATTEMPTED TO GET MORE DETAILS 10/8. H.3 LAB EVALUATION CONFIRMED THE SET TO LEAK FROM A SPLIT IN THE CASSETTE FILM AT THE INLET VALVE. THE LEAKAGE OCCURS AFTER CONTINUOUS USE IN THE PUMP; HOWEVER, THE PROBLEM IS NOT WITH THE PUMP, BUT  WITH THE SET. THE CASSETTE'S SILICONE RUBBER INLET TUBING HAS BEEN ONBSERVED TO MOVE WHILE IN USE. THIS HAS BEEN FOUND TO OCCUR ONLY ON THE CASSETTE AUTOMATED ASSEMBLY PROCESS. IMMEDIATE ACTION HAS BEEN TAKEN TO RESTRICT THE MANUFACTURING PROCESS TO THE MANUAL PROCESS ONLY. IN ADDTIION, IMPROVEMENTS TO THE MATERIAL AND AUTOMATED PROCESS HAVE BEEN DEVELOPED. A PRODUCT ADVISORY IS BEING FORWARDED TO CUSTOMERS 10/96.
THE PENCIL ACTIVATED ON ITS OWN. INTERMITTENCY.
ACTUAL DEVICE DISCARDED AT HOSP. THEY WERE UNABLE TO PROVIDE CO WITH A C/N OR L/N OF THE SUSPECT DEVICE.
THIS IS THE FOURTH OF SEVEN REPORTS OF ENDOPHTHALMITIS RECEIVED FROM AN OPHTHALMOLOGIST ASSOCIATED WITH POST OPERATIVE CATARACT EXTRACTION WITH POSTERIOR INTRAOCULAR LENS IMPLANT. IN THIS CASE, SURGERY WAS DONE ON 8/5/96. A MODEL 809F/+22.5(D) WAS IMPLANTED INTO THE LEFT EYE POST CATARACT EXTRACTION. ON 8/13/96 FINDINGS, FINDINGS OF ENDOPHTHALMITIS WERE NOTED IN EXAM AND THE PT WAS REFERRED TO A SPECIALIST. HE WAS TREATED WITH ANTIOBIOTICS INITIALLY WITH NO IMPROVEMENT. A VITRECTOMY WAS PERFORMED ON 8/14/96. THE CULTURE WAS NEGATIVE. THE OPHTHALMOLOGIST HAS NOTED EIGHT OCCURRENCES OF ENDOPHTHALMITIS SEVEN ASSOCIATED WITH LENSES MFG BY CO AND ONE WITH ANOTHER BRAND LENS FROM 11/17/94 TO 9/16/96. CURRENTLY A HOSP INVESTIGATION IS IN PROGRESS. A REVIEW OF BATCH RECORDS FOR THIS LENS INCLUDED STERILIZATION PROCESS AND STERILIZATION TESTS REVEALED NO DEVIATIONS. ADD'L INFO IS BEING SOUGHT AS WELL AS A REPORT OF THE HOSP INVESTIGATION.
THE SVC REPORT SHOWS THAT CO'S CUSTOMER SUPPORT ENGINEER WAS NOTIFIED OF DAMAGE CONCERNING THE VENTILATOR. THE CSE VERIFIED THE UNIT'S FILTER HEATER ASSEMBLY WAS DAMAGED AND HE REPLACED THE ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. IT WAS NOT DETERMINED HOW THE FILTER ASSEMBLY BECAME DAMAGED BUT CUSTOMER ABUSE OR MISHANDLING IS SUSPECTED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
SURGERY CLAIMS THE FOLEY WOULD NOT DEFLATE.
INITIAL PERFORMANCE EVALUATION OF THE RETURNED UNIT FOUND THE BALLOON TO INFLATE AND DEFLATE AS EXPECTED. BALLOON PLACEMENT AND LENGTH WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. LOT HISTORY REVIEW WAS UNREMARKABLE. SYMMETRY WAS CHECKED AND WITHIN SPECIFICATION. 37C WATERBATH TESTING WAS SATISFACTORY. CO SUSPECTS, BASED UPON EXPERIENCE THAT THE SYRINGE NOZZLE WAS NOT FULLY INSERTED IN THE VALVE WHEN THE CUSTOMER TRIED TO DEFLATE THE BALLOON. THIS WOULD LEAD TO BALLOON NON-DEFLATION. THIS REPORT MAY BE BASED UPON INFORMATION NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE SVC REPORT SHOWS THAT CO'S CUSTOMER SUPPORT ENGINEER (CSE) WAS NOTIFIED OF DAMAGE CONCERNING THE VENTILATOR. THE CSE VERIFIED THE UNIT'S FILTER HEATER ASSEMBLY WAS DAMAGED AND HE REPLACED THE ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. IT WAS NOT DETERMINED HOW THE FILTER ASSEMBLY BECAME DAMAGED, BUT CUSTOMER ABUSE OR MISHANDLING IS SUSPECTED. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
PAIR OF SCISSORS BROKE WHILE THE PHYSICIAN WAS USING THEM DURING AN OPHTHALMIC PROCEDURE. ANOTHER PAIR OF SCISSORS WAS USED TO COMPLETED THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MDR CONTACT. SCISSORS IS VERY OLD AND THE SOLDER IS WORN OFF ON THE SPRING. PITTING IS ALSO PRESENT. CORROSION MOST PROBABLY DUE TO IMPROPER CLAENING OR HARSH CLEANING SOLUTIONS.
THIS IS THE FIFTH OF SEVEN REPORTS OF ENDOPHTHALMITIS RECEIVED FROM AN OPHTHALMOLOGIST ASSOCIATED WITH POST OPERATIVE CATARACT EXTRACTION WITH POSTERIOR INTRAOCULAR LENS IMPLANT. IN THIS CASE, SURGERY WAS DONE ON 12/5/94. A MODEL, 814A/+24.00(D) WAS IMPLANTED INTO THE LEFT EYE POST CATARACT EXTRACTION. ON 12/11/94 FINDINGS OF ENDOPHTHALMITIS WERE NOTED ON EXAM AND THE PT WAS REFERRED TO A SPECIALIST. VITRECTOMY WAS PERFORMED. NO CULTURE RESULTS WERE AVAILABLE. THE OPHTHALMOLOGIST HAS HAD EIGHT OCCURRENCES OF ENDOPHTHALMITIS, SEVEN ASSOCIATED WITH LENSES MFG BY CO AND ONE WITH ANOTHER BRAND LENS FROM 11/17/94 TO 9/16/96. CURRENTLY A HOSP INVESTIGATION IS IN PROGRESS. A REVIEW OF BATCH RECORDS FOR THIS LENS WHICH INCLUDED STERILIZATION TESTS REVEALED NO DEVIATIONS. ADD'L INFO IS BEING SOUGHT AS WELL AS A REPORT OF THE HOSP INVESTIGATION.
BURST AT 16 ATMOSPHERES WITHIN THE STENT - CAUSED DISSECTION. REPAIRED WITH ANOTHER CO'S STENT.
REPORT RECEIVED FROM THE FIELD INDICATED THAT A 70 Y/O FEMALE PT WAS UNDERGOING A STENT DEPLOYMENT WITHIN A PROXIMAL LESION IN THE LAD. THE BALLOON WAS USED TO PREDILATE THE LESION. THE BALLOON BURST AT AN INFLATION PRESSURE OF 16 ATMOSPHERES WITHIN THE STENT. A DISSECTION WAS NOTED, WHICH REPORTEDLY STOPPED THE BLOOD FLOW. THE PT EXHIBITED SYMPTOMS OF ISCHEMIA AND SHE WAS TREATED PHARMACOLOGICALLY (NTG) IN ADDITION TO DEPLOYMENT OF ANOTHER CO'S STENT. THE PT'S CONDITION IS REPORTED AS SATISFACTORY. THE BALLOON CATHETER LABLELS AND INSTRUCTIONS FOR USE STATE THAT THE RATED BURST PRESSUREE SPECIFIED FOR THIS CATHETER IS 16 ATMOSPHERES. THE CATHETER IS APPROVED BY THE FOOD AND DRUG ADMINISTRATION FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY FOR DILATATION OF STENOTIC LESIONS IN CORONARY ARTERIES AND BYPASS GRAFTS. THE INSTRUCTIONS FOR USE CONTAIN A WARNING WHICH STATES "THE PTCA DILATATION CATHETERS ARE NOT INTENDED FOR STENT EXPANSION." PLEASE NOTE THAT THE USE OF THE PTCA BALLOON CATHETER FOR POST DILATATION/STENT TACKING IS NOT AN FDA APPROVED INDICATION FOR USE FOR THIS CATHETER. THEREFORE CO ASSUMES NO RESPONSIBILITY OR MAKES NO CLAIMS RELATIVE TO ITS PERFORMANCE, SAFETY OR EFFICACY IF IT IS USED FOR THAT APPLICATION.
THE SVC REPORT SHOWS THE CUSTOMER ALLEGED THAT THE AUDIBLE ALARM WAS NOT ACTIVATING. CO'S CUSTOMER SUPPORT ENGINEER (CSE) COULD NOT VERIFY THE MALFUNCTION. THE CSE AS A PRECAUTION REPLACED THE UTILITY HARNESS, THE POWER SWITCH AND THE ALARM ASSEMBLY. THE UNIT PASSED EXTENDED SELF TESTING. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
A REPORT WAS FORWARDED TO CO THAT A SINGLE HEAD PUMP S/N 10H4405, IN THE ARTERIAL POSITION HAD STOPPED DURING A BYPASS PROCEDURE. THE DISPLAY SHOWED A(--) FLASHING DISPLAY. THERE WAS NO EXTERNAL LIGHT OR LOAD LIGHT. THE PERFUSIONIST TURNED OFF THE PUMP TO RESET IT AND IT STARTED UP AND RAN FOR A FEW MINS AND THEN STOPPED AGAIN. HE RESET IT AGAIN AT WHICH TIME IT STARTED UP AND CONTINUED TO RUN. THE PERFUSIONIST CHOSE TO CHANGE OUT THE PUMP AS A PRECAUTION AND THE CASE CONTINUED WITHOUT EVENT. THERE WAS NO PT IMPACT.
CORONARY HEART DISEASE (NO CODE). BYPASS, CORONARY (NO CODE).
TIBIAL INSERT DID NOT FIT THE TIBIAL TRAY.
THIS IS THE SIXTH OF SEVEN REPORTS OF ENDOPHTHALMITIS RECEIVED FROM AN OPHTHALMOLOGIST ASSOCIATED WITH POST OPERATIVE CATARACT EXTRACTION WITH POSTERIOR INTRAOCULAR LENS IMPLANT. IN THIS CASE, SURGERY WAS DONE ON 12/16/94. A MODEL 809F/+19.0(D) WAS IMPLANTED INTO THE RIGHT EYE POST CATARACT EXTRACTION. ON 12/29/94, FINDINGS OF ENDOPHTHALMITIS WERE NOTED ON EXAM AND THE PT WAS REFERRED TO A SPECIALIST. VITRECTOMY WAS PERFORMED AND A CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS COAGULASE NEGATIVE. THE OPHTHALMOLOGIST HAS HAD EIGHT OCCURRENCES OF ENDOPHTHALMITIS, SEVEN ASSOCIATED WOTH LENSES MFG CO AND ONE  WITH ANOTHER BRAND LENS FROM 10/17/94 TO 9/19/96. CURRENTLY A HOSP INVESTIGATION IS IN PROGRESS. A REVIEW OF BATCH RECORDS FOR THIS LENS WHICH INCLUDED STERILIZATION PROCESS AND STERILIZATION TESTS REVEALED NO DEVIATIONS. ADD'L INFO IS BEING SOUGHT AS WELL AS A REPORT OF THE HOSP INVESTIGATION.
THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER ALLEGED THAT THE VENTILATOR'S AUDIBLE ALARM FAILED TO ACTIVATE. THE CUSTOMER'S BIO-MEDICAL TECH COULD NOT DUPLICATE THE EVENT REPORTED BY THE CUSTOMER'S CLINICIAN. AFTER CONSULTING WITH A CO'S TECH SUPPORT SPECIALIST, THE BIO-MEDICAL TECH REMOVED AND REPLACED THE AUDIBLE ALARM ASSEMBLY. THE UNIT WAS RETURNED TO SVC. IT WAS FURTHER REPORTED THAT THERE WAS NO PT INVOLVEMENT. THIS REPORT IS NOT AN ADMISSION BY CO THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
BASED UPON INFO IN CO'S POSSESSION, IT IS UNKNOWN WHETHER THIS EVENT HAS OCCURRED AT A GREATER FREQUENCY OR SEVERITY THAN IS USUAL FOR THE DEVICE. CO WAS NOT AUTHORIZED TO EVALUATE OR REPAIR THE DEVICE. THE CUSTOMER UTILIZES ITS OWN BIO-MEDICAL TECHNICIANS TO EVALUATE OR REPAIR THE DEVICE. THIS REPORT IS BASED ON INFO SUPPLIED TO CO BY THE CUSTOMER.
THE DEVICE WAS SET TO A RATE OF 100ML/HR, BUT DELIVERED 1000 ML IN 2 HOURS. THE BIOMEDICAL ENGINEER FROM THE HOSPITAL ATTEMPTED TO DUPLICATE THE FAILURE AND COULD NOT DUPLICATE. THERE WAS NO PATIENT INJURY.
THIS EVENT HAS OCCURRED OR IS OCCURRING MORE FREQUENTLY THAN IS STATED IN ITS LABELING OR, IF NO PERTINENT STATEMENT IS CONTAINED IN THE LABELING, THAN IS USUAL FOR THIS DEVICE. THIS EVENT HAS OCCURRED OR IS OCCURRING WITH GREATER SEVERITY THAN IS STATED IN ITS LABELING OR, IF NO PERTINENT STATEMENT IS CONTAINED IN THE LABELING THAN IS USUAL FOR THIS DEVICE. NOH-3-PERFORMED VOLUMETRIC ACCURACY TESTING. TESTING WITHIN SPECIFICATIONS. PT INFO REQUESTED.
THE FIXATOR WAS PREVIOUSLY APPLIED AT A DIFFERENT HOSP APPROX 5 WEEKS AFTER APPLICATION IT WAS NOTED THAT THE SERRATED JOINT APPEARED TO HAVE LOOSENED. A SECOND SURGERY WAS PERFORMED TO RE-REDUCE THE FRACTURE AND TIGHTEN THE FIXATOR. APPROX ONE WEEK LATER THE PT FELL FROM HIS WHEELCHAIR WHICH RESULTED IN THE LOSS OF FRACTURE REDUCTION. SURGERY WAS PERFORMED TO RE-REDUCE THE FRACTURE AGAIN.
THIS IS THE SEVENTH OF SEVEN REPORTS OF ENDOPHTHALMITIS RECEIED FROM AN OPHTHALMOLOGIST ASSOCAITED WITH POST OPERATIVE CATARACT EXTRACTION WITH POSTERIOR INTRAOCULAR LENS IMPLANT. IN THIS CASE, SURGERY WAS DONE ON 11/17/94. A MODEL 814A/+23.5(D) WAS IMPLANTED INTO THE RIGHT EYE POST CATARACT EXTRACTION. ON 1/26/95, FINDINGS OF INFLAMMATION OR INFECTION WERE NOTED AND THE PT REFERRED TO A RETINAL SPECIALIST FOR FURTHER EVAL. A DIAGNOSIS ON ANTERIOR UVEITIS AND QUESTIONABLE ENDOPHTHALMITIS WERE MADE. THE PT WAS TREATED WITH ANTIBIOTICS. THE OPHTHALMOLOGIST HAS HAD EIGHT OCCURRENCES OF ENDOPHTHALMITIS, SEVEN ASSOCIATED WITH LENSES MFG BY CO AND ONE WITH ANOTHER BRAND. LENS FROM 11/17/94 TO 9/19/96. A REVIEW OF BATCH RECORDS FOR THIS LENS FROM 11/17/94 TO 9/19/96. A REVIEW OF BATCH RECORDS FOR STERILIZATION TESTS REVEALED NO DEVIATIONS. ADD'L  INFO IS BEING SOUGHT AS WELL AS A REPORT OF THE HOSP INVESTIGATION.
THE HANDLE OF THE DEVICE BROKE DURING STONE REMOVAL AND THE PT WAS TAKEN TO SURGERY FOR REMOVAL OF THE STONE AND BASKET. THE 79 YR OLD MALE PT WAS TAKEN TO ICU AND WAS CONNECTED TO A VENTILATOR. THE RN STATED THAT THE DEVICE WILL NOT BE SENT FOR EVALUATION.
CO CANNOT EVALUATE POSSIBLE CAUSE(S) OF BREAKAGE SINCE THE DEVICE WILL NOT BE RETURNED. HOWEVER, THE INSTRUCTION MANUAL FOR THE DEVICE CAUTIONS USER NOT TO USE EXCESSIVE FORCE DURING THE PROCEDURE. THE MANUAL ALSO DESCRIBES INSTRUCTIONS WFOR MEDICAL PERSONNEL SHIFTING TO SURGICAL MEASURES, IF NECESSARY.
PT UNDERGOING PTCA. A DESIGN DEFECT IN THE PROTECTIVE SHEATH COVERING PRECIPITATED THE SHEATH REMAINING OVER THE BALLOON AND SUBSEQUENTLY BECOMING LODGED IN THE PT'S LEFT MAIN CORONARY ARTERY. SURGERY REQUIRED FOR REMOVAL.
THIS CATHETER WAS USED TO DILATE AN ANASTOMOTIC STENOSIS OF AN ILEAL CONDUIT. THE URETER WAS OVERINFLATED RESULTING IN URETERAL RUPTURE. A STENT WAS PLACED FOR EXTERNAL DRAINAGE. THE PT WAS FINE AND DID NOT EXPERIENCE ANY CLINICAL CONSEQUENCE. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAULLURE ANALYSIS WIL BE AVAILABLE. THIS IS A NON-INDICATED USE FOR THIS BALLOON CATHETER. NO MALFUNCTION OF THIS DEVICE WAS REPORTED TO HAVE OCCURRED. THE PHYSICIAN STATED THE URETERAL RUPTURE WAS THE RESUOLT OF OVERINFLATING THE URETER. CO THEREFORE DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE. CO'S DIRECTIONS FOLR USE STATE: BALLOON DILATATION CATHETERS ARE RECOMMENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE ILIAC, FEMORAL AND RENAL ARTERIES AND FOR THE TREATMENT OF OBSTRUCTIVE LESION OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE. ANY USE FOR PROCEDURES OTHER THAN THOSE INDICATED IN THESE INSTRUCTION IS NOT RECOMMENDED. IF LOSS OR PRESSURE WITHIN THE BALLOON OCCURS DURING INFALTION OF IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
INFO SUPPLIED IN SECTION F WAS COMPETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THID MEDWATH REPORT TO THE FDA.
REPORT WAS RECEIVED FROM A PHYSICIAN VIA CUSTOMER SERVICE RETURNED OF ANTERIOR CHAMBER IOL MODEL UV65B/+18.5(D) WHICH WAS IMPLANTED INTO A WOMAN'S RIGHT EYE ON 1/15/96. ANISOMETROPIA WAS REPORTED AS THIS WOMAN CONTINUED TO HAVE VISION PROBLEMS WITH A POST OPERATIVE REFRACTION OF +3. THE PHYSICIAN QUESTIONED AS TO WHETHER THE POWER OF THE LENS WAS CORRECT. SUBSEQUENTLY, THE ANTERIOR IOL WAS EXPLANTED AND A POSTERIOR CHAMBER LENS WAS IMPLANTED AND SUTURED IN PLACE (9/96). THIS WOMAN HAD PREVIOUSLY HAD A CATARACT EXTRACTION OF HER LEFT EYE WITH NO PROBLEMS. AFTER SURGERY, HER VISION IS IMPROVED WIRH 20/40 VISION UNCORRECTED. ADD'L INFO IS BEING SOUGHT. THE LENS IS BEING RETURNED FOR EVAL.
PT WITH SEVERAL MONTH'S HISTORY OF DIZZINESS FELL TWICE AT HOME. PULSE RATE AFTER SECOND FALL NOTED TO BE 44. HEART RATE HAD BEEN WITHIN NORMAL LIMITS PRIOR TO THE FALL. FLUOROSCOPY EXAMINATION SHOWED A LEAD FRACTURE. RELATED TO SUBCLAVIAN CRUSH INJURY. LEAD REPLACED 9/13/96. THE NEW LEAD WAS REVISED 9/14/96 SECONDARY TO MICRODISLODGEMENT. NO OTHER PROBLEMS REPORTED WITH THE PACEMAKER SYSTEM PRIOR TO 9/19/96 DISCHARGE.
IT WAS REPORTED THAT THE CATHETER WAS IN PLACE ONLY 3 TO 4 DAYS BEFORE PHLEBITIS DEVELOPED. IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE EXIT SITE. THE CATHETER WAS REMOVED.
THREE UNOPENED SAMPLES FROM THE SAME LOT WERE RETURNED FOR EVALUATION. A LOT HISTORY REVIEW INDICATED NO RELATED COMPONENT OR MANUFACTURING ISSUES. ALL TRAY SEALS WERE EXAMINED AND FOUND TO BE COMPLETELY INTACT AND AT LEAST 1/4 INCH WIDE AROUND THE CIRCUMFERENCE OF EACH TRAY. THERE WERE NO CRACKS IN THE TRAY, NO VISIBLE BREACHES IN THE STERILE BARRIERS AND NO DEBRIS CONTAMINATION IN ANY TRAY. UNDER MAGNIFICATION, NO SURFACE IRREGULARITIES WERE NOTED ALONG THE LENGTHS OF THE CATHETERS. THE OUTER DIAMETER OF EACH CATHETER WAS MEASURED AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. EACH SAMPLE WAS PRESSURIZED WITH A 6CC SYRINGE AND COLORED WATER BY OCCLUDING THE DIATAL END OF THE TUBING WITH A PADDED CLAMP. NO LEAKS WERE DETECTED. THIS WAS REPEATED SEVERAL TIMES WHILE EXTERTING PRESSURES ABOVE 40PSI AND THE TUBING COULD NOT BE MADE TO LEAK. THE CATHETER FLUSHED AND ASPIRATED NORMALLY. NO DEFECTS WERE FOUND AND THE CATHETERS WERE FREE OF ABNORMALITIES AND FUNCTIONED NORMALLY.
THE RPTR STATED THAT THE FEMALE LUER ON THE BIFUSE CRACKED AND LEAKED ALLOWING BLOOD TO BACK UP IN THE CONNECTOR.
THE CUSTOMER RETURNED 2 SAMPLES TO CO FOR EVAL. EXAM OF THE RETURNED UNITS SHOWED THAT ON ONE UNIT. THE FEMALE LUER WAS SPLIT. THE DAMAGE IS INDICATIVE OF THE LUER BEING OVERSTRESSED. THE OTHER UNIT SHOWED NO SIGNS OF VISUAL OR FUNCTIONAL DEFECTS. LOT HISTORY REVIEW WAS NOT AVAILABLE AS THE L/N WAS UNKNOWN TO THE CUSTOMER. CO WAS ABLE TO CONFIRM-THIS ISSUE AND TO DETERMINE THE PROBABLE CAUSE. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
THIS REPORT WAS DETERMINED TO BE NECESSARY AS A RESULT OF A COMPLAINT RECEIVED BY CO ON ONE OF ITS PRODUCTS, AN APNEA MONITOR. CUSTOMER CONTACTED CO ON 10/8/96 AND STATED THAT DURING SIMULATOR TESTING, THE MONITOR WOULD NOT INDICATE ALARM CONDITIONS. THIS INFO WAS ENTERED INTO CO'S COMPLAINT-HANDLING SYSTEM. THE COMPLAINT FORM WAS RECEIVED BY QA ON 10/10/96, ACCORDING TO STANDARD PROCEDURE, AND IT WAS DETERMINED THAT THIS MAY BE AN MDR-REPORTABLE MALFUNCTION. QA CONSULTED WITH REGULATORY AFFAIRS OFFICE AND IT WAS DETERMINED THAT CUSTOMER SHOULD BE CONTACTED FOR FURTHER INFO. CO'S CUSTOMER SERVICE REP. WHO TOOK THE CALL FROM CUSTOMER ON 10/8/96 WAS GIVEN ADD'L INSTRUCTION ON DETECTING POTENTIALLY-REPORTABLE MALFUNCTIONS). CUSTOMER WAS CONTACTED 10/10/96 FOR ADD'L INFO. THE MONITOR HAD JUST BEEN SENT TO CO IN SEPT FOR ANNUAL PREVENTIVE MAINTENANCE AND UPON ITS RETURN TO CUSTOMER NO 10/8/96, CUSTOMER WAS CONDUCTING A ROUTINE CHECKOUT BEFORE PLACING IN INVENTORY. THEIR CHECKOUT INVOLVES THE USE OF AN ECG/RESPIRATION SIMULATOR. DURING THIS CHECKOUT PROCEDURE, CUSTOMER NOTED THAT THE MONITOR WOULD NOT INDICATE ALARM CONDITIONS. MONOTOR HAD NOT YET BEEN USED ON A PT AFTER ITS RETURN FROM ANNUAL MAINTENANCE. ASKED CUSTOMER IF THERE WAS ANY INDICATION OF SHIPPING DAMAGE. ASKED THEM TO LOOK CAREFULLY AT SHIPING CONTAINER. CUSTOMER REPORTED THAT THERE WERE NO SIGNS OF SHIPPING DAMAGE. (NOTE: PRIOR TO ITS RETURN TO CUSTOMER IN EARLY OCT., S/N 21914 PASSED ALL FACTORY TESTS AND INSPECTIONS.  UNIT WAS SHIPPED TO CO VIA UPS ON 10/8/96. UNIT ARRIVED 10/9/96. AFTER ALL INFO DESCRIBED ABOVE HAD BEEN GATHERED AND DOCUMENTED ON COMPLAINT FORM, THE UNIT WAS RELEASED FROM CO RECEIVING DEPT. FOR EVAL. UPON COMPLETION OF EVAL IT WAS DETERMINED THAT AN MDR WAS REQUIRED.
VERIFIED THE REPORT PROBLEM BY OPERATING MONITOR ON TEST BENCH WITH A SIMULATOR, 10/10/96. PROBLEM WAS NOTED IMMEDIATELY. OPENED MONITOR AND FOUND CAUSE. WHEN UNIT WAS RECENTLY IN FACTORY, DURING ROUTINE ANNUAL PREVENTIVE MAINTENANCE, A CRACKED TOP COVER WAS REPLACED. AT THAT TIME, THE TECH SELECTED A REPLACEMENT COVER THAT HAD NOT BEEN SENT THROUGH THE NORMAL MACHINE SHOP PROCESS TO PERFORM A TRIMMING OPERATION. THE TECH PERFORMED THE TRIMMING ON THIS REPLACEMENT COVER BY HAND. THE TRIMMING OPERATION IS A NORMAL REQUIRED STEP FOR THIS HOUSING BECAUSE THE HOUSING IS A STANDARD OFF-THE SHELF PRODUCT WHICH CAN HAVE MANY APPLICATIONS. CO'S APPLICATION FOR THIS APNEA MONITOR REQUIRES CERTAIN MOLDED PLASTIC FEATURES ON THE INTERIOR TO BE TRIMMED TO ACCOMMODATE CIRCUIT BOARD MOUNTING. STANDARD PROCEDURE IS THAT THIS IS PERFORMED IN A MACHINE SHOP. THE TECH OBTAINED AN UNTRIMMED COVER AND DID THE TRIMMING BY HAND, BUT HE DID NOT TRIM ENOUGH OF THE MATERIAL. AS A RESULT, THE CIRCUIT BOARD CARRYING PRINTED TRACES FOR THE MONITOR'S ALARM SECTION COULD NOT BE PROPERLY LOCATED TO CLEAR A STUD. STUDS ON THE TOP AND BOTTOM CASE CLOSE TIGHTLY TOGETHER WHEN THE CASE SCREWS ARE FASTENED. THE BOARD WAS SITUATED BETWEEN THESE STUDS. PRESSURE FROM BEING PINCHED IN THIS MANNER CAUSED INTERMITTENT BROKEN TRACES, THUS CAUSING EVENTUAL MALFUNCTION OF THE INDICATORS. THE MONITOR AS RECEIVED FROM CUSTOMER WAS FOUND TO MEET ALL OTHER SPECS. IT WAS DETERMINED THAT THIS IS AN ISOLATED INCIDENT: THIS WAS THE ONLY MONITOR REPAIRED WITH A HAND-TRIMMED HOUSING. CORRECTIVE ACTION: STUDS WERE TRIMMED TO PRINT; THE TECH RESPONSIBLE FOR SELETING THE UNTRIMMED CASE FOR HIS REPAIR ACTION WAS INSTRUCTED TO ONLY USE THE HOUSING PART NUMBER REQUIRED BY ENGINEERING DRAWING, WHICH IS THE TRIMMED HOUSING. THE CIRCUIT BOARD FOR THIS MONITOR WAS REPLACED SINCE THE TRACES HAD BEEN FRACTURED FROM HAVING BEEN PINCHED BETWEEN THE STUDS. S/N 21914 WAS RETURNED TO FULL SPEC COMPLIANCE AND SENT BACK TO CUSTOMER. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MED. PERSONNEL, UF, MFR, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THIS REPORT CONTAINS INFO REPORTED TO IBI AND MAY NOT CONTAIN OUR REPRESENTATION OF FACT AFTER FURTHER INVESTIGATION. NEITHER THE SUBMISSION OF THIS OR OTHER INFO TO THE FDA NOR PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHED THE EXISTENCE OF ANY CONNECTIONS BETWEEN A PRODUCT AND A DEATH OR SERIOUS INJURY.
IT WAS REPORTED THAT THE PT DEVELOPED PHLEBITIS. WARM COMPRESSES WERE APPLIED TO THE SITE, THE CATHETER WAS THEN REMOVED AND A PERIPHERAL LINE WAS STARTED.
THE MFR IS CURRENTLY EVAUATING SAME LOT SAMPLES RETURNED BY THE USER FACILITY. THREE UNOPENED SAMPLES FROM THE SAME LOT WERE RETURNED FOR EVALUATION. A LOT HISTORY REVIEW INDICATED NO RELATED COMPONENT OR MANUFACTURING ISSUES. ALL TRAY SEALS WERE EXAMINED AND FOUND TO BE COMPLETELY INTACT AND AT LEAST 1/4 INCH WIDE AROUND THE CIRCUMFERENCE OF EACH TRAY. THERE WERE NO CRACKS IN THE TRAY, NO VISIBLE BREACHES IN THE STERILE BARRIERS AND NO DEBRIS CONTAMINATION IN ANY TRAY. UNDER MAGNIFICATION, NO SURFACE IRREGULARITIES WERE NOTED ALONG THE LENGTHS OF THE CATHETERS. THE OUTER DIAMETER OF EACH CATHETER WAS MEASURED AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. EACH SAMPLE WAS PRESSURIZED WITH A 60CC SYRINGE AND COLORED WATER BY OCCLUDING THE DISTAL END OF THE TUBING WITH A PADDED CLAMP. NO LEAKS WERE DETECTED. THIS WAS REPEATED SEVERAL TIMES WHILE EXTERTING PRESSURES ABOVE 40PSI AND THE TUBING COULD NOT BE MADE TO LEAK. THE CATHETER FLUSHED AND ASPIRATED NORMALLY. NO DEFECTS WERE FOUND AND THE CATHETERS WERE FREE OF ABNORMALITIES AND FUNCTIONED NORMALLY.
PT IN SURGERY FOR EXCISION OF GRANULOMA OF RIGHT LACRIMAL CARNUCLAUNDER LOCAL WITH ANESTHESIA STANDBY. PHYSICIAN USING A HANDHELD CAUTERY TO LAST AREA. AS HE DID THAT A SUDDEN FLASH EMANATED UNDERNEATH THE DRAPE AND IMMEDIATELY REMOVED THE CAUTERY FROM THE AREA AND PT AT THE SAME TIME SAT UP. FIRE OCCURRED AND PT REC'D SECOND, POSSIBLY THIRD DEGREE BURNS TO THE FACE AND LEFT POSTERIOR SHOULDER, LINEAR STREAK ON CHEST, MINOR AREAS ON CHEST WHERE THE ELECTRODE(EKG)  WOULD HAVE BEEN, BLISTERS ON THE PT WAS TRANSFERRED TO ANOTHER HOSP THAT HAD A BURN UNIT. TWO OTHER PHYSICIANS EXAMINED HIM PRIOR TO THE TRANSFER, ONE DID A FIBEROPTICNASAL PHARYNGOSCOPE PRIOR TO THE TRANSFER.
THIS IS THE THIRD OF SEVEN REPORTS OF ENDOPHTHALMITIS RECEIVED FROM AN OPHTHALMOLOGIST ASSOCIATED WITH POST OPERATIVE CATARACT EXTRACTION WITH POSTERIOR INTRAOCULAR LENS IMPLANT. IN THIS CASE, SURGERY WAS DONE ON 12/5/94. A MODEL 814A/+22.5(D) WAS IMPLANTED INTO THE RIGHT EYE POST CATARACT EXTRACTION. ON 12/17/94, FINDINGS OF ENDOPHTHALMITIS WERE NOTED ON EXAM AND THE PT WAS REFERRED TO A SPECIALIST. VITREOUS TAP WITH INJECTION OF INTRAVITREOUS ANTIBIOTICS AS WELL AS SUBCONJUNCTIVAL ANTIOBIOTICS WAS PERFORMED ON 12/18/94. CULTURES WERE NEGATIVE. THE OPHTHALMOLOGIST HAS HAD EIGHT OCCURRENCES OF ENDOPHTHALMITIS, SEVEN ASSOCIATED WITH LENSES MFG BY CO AND ONE WITH ANOTHER MFR'S LENS FROM 11/17/94 TO 9/19/96. CURRENTLY A HOSP INVESTIGATION IS IN PROGRESS. A REVIEW OF BATCH RECORDS FOR THIS LENS WHICH INCLUDED STERILIZATION PROCESS AND STERILIZATION TESTS REVEALED NO DEVIATIONS. ADD'L INFO IS BEING SOUGHT AS WELL AS A REPORT OF THE HOSP INVESTIGATION.
A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY. DURING ATTEMPTS TO ADVANCE A SECOND CORONARY STENT PROXIMAL TO THE FIRST STENT, A DISSECTION WAS NOTED FOLLOWING LOSS OF GUIDEWIRE SUPPORT AND A CORONARY VESSEL SPASM WAS ALSO OBSERVED. NO FURTHER CORONARY STENT DEPLOYMENT WAS ATTEMPTED DUE TO THE OBSERVED DISSECTION AND SPASM, AND THE ANATOMY OF THE CORONARY VESSELS. THE PT WAS SENT FOR ELECTIVE CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE PORT WAS PLACED 7/14/95 FOR ANEMIA THERAPY. IN 9/96, THE PORT WAS BEING FLUSHED AFTER AN ENDOSCOPY IV AND THE PT REPORTED DISCOMFORT IN THE CHEST. AN X-RAY WAS DONE A FDEW DAYS AFTER THAT, WHICH SHOWED THAT THE CATHETER HAD BROKEN OFF AT THE PORT STEM.
A PORT AND CATHETER FRAGMENT WERE RETURNED FOR EVAL. CATHETER HAD BEEN SEVERED FROM PORT JUST DISTAL TO PORT CONNECTION, FLUSH WITH CATH-LOCK STRAIN RELIEF. A LARGE AMOUNT OF TISSUE WAS ADHERED TO CATH-LOCK. THERE WAS A BLACK SUTURE FILAMENT ENCASED IN TISSUE. SEVERED END OF CATHETER FRAGMENT APPEARED BROKEN AND COMPRESSED AND TUBING CURVED TOWARDS BREAK. EXTERIOR OF FRAGMENT WAS DULLED, ESPECIALLY ALONG BLUE STRIPE. ONE DOT MARK WAS MISSING. TWO DOT MARK APPEARED TO BE DEGRADED FROM WEAR. INITIAL EVAL SHOWED BOTH SEGMENTS TO BE PATENT. SEVERED FRAGMENT WAS INSPECTED TACTUALLY FOR ELASTIC WEAKNESS OR DEFORMATION AND NO TENSILE ELONGATION WAS NOTED. UNDER MANGIFICATION, BROKEN END OF SEVERED SEGMENT WAS COMPRESSED AND OVAL SHAPED. IT WAS SPLIT IN BOTH CORNERS OF OVAL. OUTER DIAMETER AT BREAK APPEARED DULL FROM ABRASION. ENDS OF CATHETER AT BREAK POINT MATCHES WHEN MATED. SURFACE TEXTURE OF BROKEN PLANE WAS VERY GLOSSY AND POLISHED AROUND HALF OF CIRCUMFERENCE. OTHER HALF APPEARED DULL AND GRANUALR WITH IRREGULAR STRIATION ACROSS PLAIN. THIS NORMALLY INDICATES A CUT THAT RESULTED IN A TENSILE BREAK. BLACK SUTURE FILMENT WAS VERIFIED TO BE ENCAPUSLATED IN TISSUE AND NOT UNDERNEATH STRAIN RELIEF AS TISSUE AND SUTURE CAN BE LIFTEF ROM SILICONE STRAIN RELIEF. THIS IS LIKELY MATERIAL USED TO SUTURE CATHETER AT THIS LOCATION. THESE SIGNS MAY INDICATE THAT TUBING WAS CUT AT SUTURE SITE. A TIGHTLY TIED SUTURE CAN COMPRESS AND CUT OR ABRADE INTO OUTER DIAMETER OF TUBING THROUGH NATURAL MOVEMENT INSIDE BODY. THIS WEAR CAN ALSO DULL SUFRACE OF TUBING. ONCE CUT, TUIBING CAN EASILY BREAK FROMTUGGING INSIDE BODY. THIS IS PROBABLE, GIVEN THAT PORT WAS IN PT OVER ONE YEAR. ONCE TUBING WAS CUT, FRAGMENT WAS THEN FREE TO EMBOLIZE.
ACIDOSIS DIABETIC: A WOMEN REPORTED THAT SHE WAS HOSPITALIZED IN JAN. OF 1995 FOR THREE DAYS FOR DKA WHEN USING NOVOLIN R (RDNA) PENFILL INSULIN IN A DEVICE, WHICH SHE FEELS MALFUNCTIONED. ON THE DAY OF THE EVENT HER FASTING BG LEVEL WAS ELEVATED, SO SHE TOOK HOURLY INJECTIONS OF NOVOLIN R USING THE DEVICE. AFTER 12 HOURS OF ELEVATED BG LEVELS, SHE WAS ADMITTED TO THE HOSP. SHE STATED THAT BECAUSE THE VIEWING WINDOW ON THE CARTRIDGE CASING FOR THE INSULIN CARTRIDGE WAS SMALL, SHE DID NOT DETECT A BUBBLE THAT FORMED IN THE CARTRIDGE AND FEELS THAT THE BUBBLE PREVENTED THE DELIVERY OF THE INSULIN. ANOTHER REASON SHE FEELS THAT THE INSULIN WAS NOT DELIVERED WAS BECAUSE THE PUSHBUTTON ON THE DEVICE FELT LIKE IT HAD MORE PRESSURE THAN USUAL. SHE DOES NOT REMEMBER DOING A FUNCTION CHECK ON THE DEVICE NOR DOES SHE REMEBER IF SHE DID AN AIR SHOT BEFORE EACH INJECTION, AND SHE STATED THAT SHE MAY HAVE REUSED HER DISPOSABLE NEEDLE THAT DAY. AFTER HER DISCHARGE SHE SWITCHED TO INSULIN SYRINGES AND NO FURTHER PROBLEMS WERE EXPERIENCED. THE WOMEN HAD USED THE DEVICE FOR TWO TO THREE YEARS PRIOR TO THIS EVENT AND STATED THAT THE DEVICE HAD MALFUNCTIONED TWICE BEFORE DURING THAT TIME, BUT SHE WAS ABLE TO CORRECT IT WITHIUT EXPERIENCE ANY PROBLEMS. THE DEVICE IN QUESTION HAS NOT BEEN RETURNED FOR TESTING AND IT HAS NOT BEEN POSSIBLE TO CONTACT THE ADMITTING PHYSICIAN.
IS THE EVENT LISTED IN INSERT? NO. IS THE EVENT OCCURRING MORE FREQUENT? NO. IS THE EVENT SEVERITY LISTED IN INSERT? NO. IS SEVERITY OCCURRING MORE FREQUENTLY? NO.
AN ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S POPLITEAL ARTERY. UPON THE INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON BURST AT 2-3 ATM OF PRESSURE, LEAVING THE STENT PARTIALLY EXPANDED AT THE TARGET LESION SITE. DURING WITHDRAWAL OF THE DELIVERY SYSTEM, A PORTION OF THE BALLOON REMAINED IN THE POPLITEAL ARTERY. AN ADD'L BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT AT THE TARGET LESION SITE. SUBSEQUENTLY, A THROMBUS OCCURRED AT THE LESION SITE WHICH REQUIRED NO REMEDIAL ACTION. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY.
VENT SUDDENLY WENT INOPERABLE; ALARM SOUNDED. PT VENTILATOR DEPENDENT. RN WAS AT BEDSIDE AND BEGAN MANUAL VENTILATION. MEDICATION NECESSARY TO MAINTAIN AND STABILIZE CV STATUS. FUSE BLOWN.
USER EXPERIENCED DIFFICULTY INSERTING CATHETER DUE TO PT'S ARTERIAL PATHOLOGY. REINSERTED CATHETER BY FEMORAL ACCESS. AFTER INSERTION OF CATHETER, THE BALLOON WOULD NOT INFLATE. DOCTOR OBSERVED THAT BALLOON FLEXIBILITY WAS NOT TO HIS EXPECTATION.
H10: ALL "UNK" INFORMATION REQUESTED BUT NOT RECEIVED. H10: SECTION F INFORMATION PROVIDED BY MANUFACTURER. H10: SECTION H6 METHOD CODE 86 IS LEAK TEST.
THE PUMP WAS "ADMINISTERING MEDICATION INDEPENDENT OF PT ACTIVATING THE PUMP". THE PUMP ,WAS SET TO INFUSE MORPHINE 1 MG/ML. PCA DOSE OF 1 MG WITH A 10 MINUTE LOCKOUT AND A 20 MG 4 HOUR LIMIT. INFO REGARDING THE TOAL NUMBER OF PCA DOES ADMINISTERED, THE NUMBER ACTUALLY REQUESTED AND THE NUMBER OF NON-REQUESTED DOES GIVEN WAS NOT AVAILABLE. THE PT EXPEREIENCED CONFUSION AND DROWSINESS. SHE REQUIRED TWO DOSES OF NARCAN 0.2 MG. ALL SYMPTOMS REPORTEDLY WERE RELEIVED AFTER THE PUMP WAS DISCONTINUED AND THE NARCAN WAS ADMINISTERED. THERE WAS NO REPORT OF ANY ADVERSE SEQUELAE.
THE REPORTED COMPLAINT WAS CONFIRMED. THE PT PENDANT CONNECTOR JACK HAD BEEN MANIPULATED OR STRESSED TO THE EXTENT THAT WIRING CONNECTIONS HAD BROKEN. EVEN DURING THIS SITUATION, THE PHYSICIAN PRESCRIBED PT LOCKOUT AND/OR 4 HOUR LIMIT PARAMETERS PROGRAMMED.
THIS UNIT WAS EVALUATED BY THIS HOSP, WHO FOUND THAT A FUSE HAD BLOWN ON THE POWER SUPPLY. THIS FUSE WAS REPLACED AND THIS HOSP RETURNED THIS UNIT TO USE. THIS HOSP ELECTED TO NOT SEND THIS UNIT TO THE MFR FOR FURTHER EVAL.
PREMATURE DEFLATION OF BALLOON DUE TO IMPROPER SNIPPING OF THE INFLATION. EYE WHICH WAS SNIPPED THROUGH TO THE DRAIN LUMEN & CAUSED INFLATION FLUID TO FLOW OUT DRAINAGE EYE OF CATHETER. NO OTHER REPORTS OF THIS TYPE FOR THIS DATE CODE. PROBLEM ATTRIBUTED TO OPERATOR ERROR. THE SAMPLE AND REPORT FINDINGS WERE REVIEWED WITH THE OPERATORS. NO FURTHER ACTION TAKEN. ISOLATED OCCURRENCE.
NEW CATHETER WAS INSERTED VIA A SUPRAPUBIC CYSTOTOMY.
THE TIBIAL INSERT WOULD NOT SEAT PROPERLY IN THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE EVENT WAS CAUSED BY A 45 DEGREE CHAMFER MISSING FROM THE SNAP LAB. THE MFG AND INSPECTION CRITERIA HAVE BEEN CHANGED THEREBY PREVENTING ACCEPTANCE OF PRODUCT WITHOUT THE 45 DEGREE CHAMFER.
DURING ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY, THE STENT MIGRATED TO THE DISTAL END OF THE BALLOON CATHETER. DURING AN ATTEMPT TO WITHDRAW THE DELIVERY SYSTEM AND STENT. THE STENT EMBOLIZED TO THE RIGHT FEMORAL ARTERY. THE DELIVERY SYSTEM WAS SUCCESSFULLY WITHDRAWN USING A SNARE WIRE. THE PT WAS SENT TO SURGERY FOR STENT REMOVAL FROM THE RIGHT FEMORAL ARTERY. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THIS EVENT.
THE HOSPITAL REPORTED CUTTING WIRES ON TWO SEPARATE CATHETERS TO HAVE BROKEN DURING A SINGLE PROCEDURE. NO PT INJURY WAS EXPERIENCED. NO ADD'L DETAILS ON THE CASE ARE AVAILABLE AT THIS TIME.
CATHETER CUTTING WIRES BROKE DURING TWO SEPARATE INCIDENCES, RATHER THAN ONE AS INITIALLY REPORTED. DR REPORTED THAT HE HAD TWO SEPARATE CASES IN WHICH CATHETER CUTTING WIRE BROKE DURING PROCEDURE. BOTH TIMES WERE BROKE AT PROXIMAL END, NEAR CATHETER ENTRY POINT. ON FIRST CASE, A VALLEY LAB GENERATOR WAS USED WITH A DIAL RATHER THAN AN DIGITAL READOUT AS RECOMMENDED IN DATA SHEET. ON SECONED CASE, CATHETER WAS ACTIVATED TWO TIMES AT 100 WATTS FOR 3 SECONDS. A VALLEY LAB GENERATOR WITH DIGITAL READOUT WAS USED. THE DR WAS NOT AWARE OF CALIBRATION STATUS OF GENERATORS. IN EACH CASE, CATHETER WAS REMOVED WITH BROKEN CUTTING WIRE BY PULLING THROUGH URETER WITH WIRE INVERTED. DR STATED HE HAD TO USE A LITTLE FORCE IN ORDER TO GET WIRE TO INVERT. THERE WAS NO INJURY OT EITHER PT AND BOTH CASES WERE SUCCESSFUL OUT TO SEVERAL MONTHS OF FOLLOW UP.
BLOOD WAS NOTED IN THE IAB CATHETER. IABP AND IAB CATHETER WERE DISCONTINUED. BALLOON NOTED TO HAVE RUPTURED. PT STABLE.
BILATERAL SEVERE CAPSULAR CONTRACTURE OF BREAST WITH OPEN CAPSULECTOMIES, IMPLANTS EXCHANGED WITH SALINE IMPLANTS. LEFT IMPLANT RUPTURED. RIGHT IMPLANT INTACT.
THE RPTR STATED THAT THE FEMALE LUER WAS CRACKED.
THE CUSTOMER SENT THREE SAMPLES TO CO FOR EVAL. EXAM OF THE RETURNED UNITS SHOWED THAT ONE UNIT HAD A CRACKED FEMALE LUER. THE DAMAGE IS INDICATIVE OF ABUSE AS THERE WERE HEMOSTAT MARKS ON THE LUER. ONE OF THE OTHER UNITS ALSO SHOWED EVIDENCE OF ABUSE AS TH SLIDE SWIVEL WAS SMASHED AND MISSING. LOT HISTORY REVIEW WAS NOT AVAILABLE AS THE LOT NUMBER WAS UNKNOWN TO THE CUSTOMER.
DURING PARACENTESIS, CATHETER WAS CUT BY NEEDLE WHILE IT WAS BEING WITHDRAWN. CATHETER WAS RETAINED IN ABDOMEN. TAKEN TO SURGERY FOR LAPAROSCOPY TO REMOVE CATHETER. APPROX 6" PIECE OF CATHETER WAS REMOVED.
PT UNDERGOING AORTOGRAM. DURING INJECTION, THE CATHETER RUPTURED. BLEEDING FROM ARTERY INTO TISSUE, AND INJECTION OF CONTRAST INTO TISSUE OCCURRED CAUSING HEMATOMA. PT WAS ADMITTED TO HOSP TO OBSERVE FOR BLEEDING. INJECTION SETTINGS WERE: PSI-1000 20 CC PER SECOND FOR 2 SECS.
THE RPTR STATED THAT THE MALE LUER ON THE SYRINGE CAME OFF.
THE CUSTOMER IS NOT RETURNING PRODUCT TO CO FOR EVAL. RETAINED PRODUCT SAMPLE WERE EVALUATED AND RESULTS CONFIRMED THIS ISSUE. THE LOT HISTORY WAS REVIEWED AND WAS FOUND TO BE ACCEPTABLE. THIS ISSUE IS RELATED TO A MOLDING DEFECT. THE MOLD WAS TAKEN OUT OF SVC AND REPAIRED. THIS PARTICULAR LOT WAS MFG PRIOR TO THIS CHANGE. CO WAS ABLE TO CONFIRM THIS ISSUE AND TO DETERMINE THE CAUSE BASED ON THIS INFO. CO BELIEVES THAT THIS ISSUE HAS BEEN ADDRESSED AND THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. CO CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
PT WAS SCHEDULED FOR A LAPAROSCOPIC HERNIA REPAIR. DURING THE PROCEDURE THE CAMERA WITH TELEVISION MECHANISM FAILED TO PROVIDE AN ADEQUATE PICTURE AS IT WAS TOO DARK AND ADEQUATE VISUALIZATION COULD NOT BE OBTAINED. PT SUBSEQUENTLY WAS OPENED THROUGH LOWER ABDOMINAL INCISION.
DENTAL ASST REPORTED THAT AN IMPLANT FAILED TO INTEGRATE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOG HISTORY OF THE SUBJECT PRODUCT WAS FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
ON 10/15/96, THE FACILITY NURSE CONTACTED A MFR NURSE AND REPORTED THAT SHE MANAGES TWENTY PTS WITH VASCULAR ACCESS DEVICES AND SELDOM GETS A BLOOD A RETURN. THE FACILITY NURSE REPORTED THAT ON 10/13/96, FLUID WAS NOTED AROUND THE INSERTION SITE ON THIS PT; HOWEVER, THE PT DID NOT COMPLAIN OF ANY DISCOMFORT. THE DEVICE WAS THEN HEPARIN LOCKED. ON 10/14/96, THE DEVICE WAS ACCESSED WITH A 1-1/2" NEEDLE AND A BLOOD RETURN OF 10CC WAS OBTAINED AND THEN STOPPED. AN INCREASE IN LEAKING WAS NOTED. A DYE STUDY WAS PERFORMED AND REVEALED THE TIP OF THE DEVICE CATHETER WAS TOTALLY OCCLUDED WTH DYE COMING OUT OF THE DEVICE CATHETER FURTHER UP FROM THE DEVICE CATHETER FURTHER UP FROM THE TIP WHEN EITHER OF THE TWO DEVICE SEPTA WERE ACCESSED. THE FACILITY NURSE REPORTED THAT THIS IS THE 2ND TIME THIS HAD OCCURRED IN LESS THEN TWO MONTHS. THE LAST PT HAD THE DEVICE REMOVED AND DISCARDED. THIS REPORT ADDRESSED THE FCILITY NURSES REPORT OF THIS PREVIOUS INCIDENT. THE FACILITY NURSE ALSO STATED THAT SHE SOMETIMES USES 5CC SYRINGES FOR THE HEPARIN LOCK PROCEDURE AND ALSO USES 30CC AND 50CC SYRINGES FOR ADRIAMCYIN ADMINISTRATION. THE MFR NURSE THEN DISCUSSED SYRINGE SIZE AND PSI, FLUSHING VS HEPARIN LOCK PROCEDURE, USEFULNESS OF DYE STUDIES TO DETERMINE DEVICE CATHETER PLACEMENT IN A ONE WAY OCCLUSION, AND THE USE OF UROKINASE FOR FIBRIN FOR FIBRIN SHEATHS.
THE FACILITY NURSE HAS NOT RESPONDED TO THE MFR REQUESTS FOR ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE CATALOG/LOT NUMBER FOR THIS DEVICE. AS A RESULT, THE MFR IS UNABLE TO PERFORM ANY FURTHER INVESTIGATION CONCERNING THIS EVENT. BASED ON THE LIMITED AMOUNT OF INFORMATION, AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE FACILITY WILL BE NOTIFIED OF THE MFR REVIEW OF THIS INCIDENT IN WRITING. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
DEVICE WAS IMPLANTED ON 5/6/95. REVISION SURGERY WAS PERFORMED ON 10/4/96, DUE TO DISLOCATION.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INFUFFICIENT TO PERMIOT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT. A FAX SENT TO THE USER FACILITY ON 10/22/96. CO DID NOT RECEIVED A MEDWATCH REPORT FORM FROM THE USER FACILITY.
AN ELECTROSURGICAL GENERATOR WAS RECEIVED NEW BY THE USER FACILITY. ON FIRST USE, THE UNIT DID NOT PUT OUT ANY POWER TO THE ELECTRODE, EITHER UNIPOLAR OR BIPOLAR. ANOTHER UNIT WAS SUBSTITUTED AND THE CASE WAS COMPLETED. NO PT PROBLEMS. WHEN THE UNIT WAS TESTED IN USER FACILITY'S BIOMEDICAL DEPARTMENT, IT BEGAN TO SMOKE.
DATA IN SECTION F WAS FILLED IN BY THIS MANUFACTURER. EVALUATION SUMMARY  THE DEVICE WAS FOUND TO HAVE A SHORTED TRANSISTOR (T2) WHICH MAY HAVE SMOKED DURING ACTIVATION AT THE USER FACILITY. WHEN THE TRANSISTOR SHORTED AND BURNED, IT DAMAGED RESISTOR R2. THE CAUSE OF THE TRANSISTOR T2 SHORTING OUT HAS NOT BEEN DETERMINED. THESE FACTORS RESULTED IN THE NON-TRANSMISSION OF POWER TO THE OUTPUT RECEPTABLE. TRANSISTORS T1 AND T2 AND RESISTOR R2 WERE REPLACED.
LAPAROSCOPIC CHOLECYSTECTOMY SCHEDULED. DUE TO THE INABILITY TO PROVIDE ADEQUATE TIGHTENING INTERNALLY TO VISUALIZE STRUCTURES PROCEDURE WAS UNABLE TO BE PERFORMED THROUGH THE LAPAROSCOPE. OPEN INCISION WAS MADE.
FACILITY ALLEGES CRACK IN THE BLOOD PUMP SEGMENT OF ARTERIAL LINE, RESULTING IN APPROX 80CC OF BLOOD LOSS. ARTERIAL BLOOD LINE REPLACED. WILL REQUEST A SAMPLE FROM FACILITY.
AWAITING FOR SAMPLE FOR INVESTIGATION. RESULT WILL FOLLOW.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY/QUANTITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.
FIRST DEGREE BURNS ON CHEST AND BACK UPON REMOVAL OF DEFIBRILLATOR PADS AFTER CARDIOVERSION.
ON 10/16/96, THE FACILITY'S SURGICAL MATERIALS SPECIALIST CONTACTED THE MFR'S MANAGER, PRODUCT COMPLAINTS AND LITIGATION TO REPORT THAT HAS HAD REMOVED DUE TO A FRACTURE OF THE DEVICE CATHETER. THE DEVICE CATHETER IS INTACT AND HAS A PARALLEL SLIT IN THE CATHETER. THE FACILITY'S SURGICAL MATERIALS SPECIALIST WILL RETURN THE DEVICE FOR ANALYSIS AND REQUESTS A COPY OF THE ANALYSIS RESULTS AND THAT THE PHYSICIAN ALSO RECEIVES A COPY OF THE RESULTS.
ON 1/6/97, FACILITY'S SURGICAL MATERIALS SPECIALIST INFORMED A MFR REP THAT DUE TO SOME INTERNAL ISSUES AT FACILITY, DEVICE HAS NOT BEEN RETURNED TO MFR FOR ANALYSIS. ADD'L, FACILITY'S SURGICAL MATERIALS SPECIALIST STATED THAT TO HER KNOWLEDGE, IT IS NOT KNOWN WHEN/IF DEVICE WOULD BE RETURNED. MFR'S REP INFORMED FACILITY'S SURGICAL MATERIALS SPECIALIST THAT IN VIEW OF CURRENT SITUATION, MFR HAD NO CHOICE BUT TO CLOSE FILE ON THIS EVENT; HOWEVER, SHOULD DEVICE AND/OR FURTHER INFO BECOME AVAILABEL IN FUTURE, MFR WOULD REOPEN MFR'S INVESTIGATION OF THIS INCIDENT. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG/LOT NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT. BASED ON INFO AVAILABLE AND DUE TO UNAVAILABILITY OF DEVICE. NO CONCLUSION CAN BE DRAWN AS TO CAUSE OF THIS EVENT. MFR'S INVESTIGATION OF THIS INCIDENT IS INCONCLUSIVE. NO FURTHER DETAILS ARE AVAILABLE. MFR IS NOW CLOSING FILE ON THIS EVENT. H.11. INITIAL MEDWATCH REPORT SUBMITTED ON 11/12/96, SECTION B.4. DAE OF THIS REPORT READ 11/112/96, IT SHOULD HAVE READ 10/16/96. 2) INITIAL MEDWATCH REPORT SUBMITTED ON 10/12/96, SECTION F.8. DATE OF THIS REPORT READ 11/12/96, IT SHOULD HAVE READ 10/16/96.
DURING THE PROCEDURE THE VALVE OF THIS DEVICE BECAME DISLODGED FROM THE SHEATH. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
DEVICE HISTORY RECEORD REVIEW PERFORMED.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. FAILURE ANALYHSIS IS PROVIDED.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURE APPROX 33 MM AND APPROX 39 MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFINER WIRE WAS RECEIVED WITH ALL RECORDED  MEASUREMENTS ADDING UP TO APPROX 87 MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD CONFIRMS J STIFFENER WIRE FRACTURES.
A LAPAROSCOPIC FALLOPIAN TUBE OCCLUSION PROCEDURE WAS IN PROGRESS, WHEN THE PHYSICIAN LOST A FALLOPIAN TUBE CLIP IN THE PT'S ABDOMEN. RETRIEVAL OF THE CLIP WAS NOT ACCOMPLISHED. ANOTHER CLIP WAS APPLIED WITH NO DIFFICULTIES TO COMPLETE THE SURGERY.
DATA IN SECTION F WAS FILLED IN BY THIS U.S. AGENT OF THE MANUFACTURER. H3 - DEVICE WAS EVALUATED BY THIS U.S. AGENT OF THE FOREIGN MANUFACTURER. EVALUATION SUMMARY: THE ROD THAT PERFORMS FINAL CLOSURE OF THE SPRING CLIP WAS FOUND TO BE LOOSE. THE TIP OF THE INNER SHAFT WAS LOOSE AND BENT DOWNWARD. INTERNAL ASSEMBLY PARTS WERE MISSING ENTIRELY. THESE INCLUDED THE O-RING, SPRING AND TWO METAL WASHERS. THIS DEVICE, AS RECEIVED FROM THE USER FACILITY, COULD NOT BE EXPECTED TO PERFORM AS INTENDED. CAUSE: POOR MAINTENANCE AND HANDLING OF THE DEVICE BY THE USER.
OVERDELIVERY DUE TO USER MISPROGRAMMING OF DRUG CONCENTRATION AND CONTAINER SIZE REPORTED. THE PUMP WAS SET TO DELIVER A 1 MG/ML CONCENTRATION OF MEPERIDINE, PCA DOSE OF 10 MG WITH A 10 MINUTE LOCKOUT, A BOLUS LIMT AND A 50 ML IV CONTAINER WITH MEPERIDINE 50 MG/ML. THE PHARMACIST STATES THE BAG WAS CLEARLY LABELED, AND SHE HAD DISCUSSED WITH A NURSE ON THE PHONE THAT THE CONTAINER HELD A CONCENTRATION OF 50 MG/ML. THE DEVICE WAS INCORRECTLY PROGRAMMED, AS NOTED ABOVE, WITH A CONCENTRATION OF 1 MG/ML AND A CONTAINER SIZE OF 50 MG. AFTER PROGRAMMING THE DEVICE, A BOLUS WAS REQUESTED WHILE THE NURSE WAS IN THE ROOM. WHEN THE PUMP KEPT INFUSING PAST WHAT SHE EXPECTED TO BE A 1 ML DELIVERY, THE NURSE STOPPED THE INFUSION. THE ACTUAL DELIVERED BOLUS WAS APPROX 80 MG. THE PT BECAME DROWSY AND RECEIVED ONE DOSE OF NARCAN TO PRECLUDE ANY ADVERSE EFFECTS. SHE DID WELL, AND THERE WAS NO REPORT OF ANY ADVERSE SEQUELAE.
THE PUMP'S HISTORY LOG REVEALED THE PROGRAM WAS 1 MG/ML, 10 MG BOLUS, 6 MINUTE LOCKOUT, AND THE CONTAINER WAS SET AT 50MG. A BOLUS DELIVERY WAS STOPPED AT 19:29 AFTER INFUSING 1.6MB. AN INFUSION TEST WITH ABOVE PROTOCOL INFUSED WITHIN SYSTEM ACCURACY, % ERROR WAS -1.46. THE PHARMACIST AT THE FACILITY REPORTED THE CONCENTRATION WAS SUPPOSED TO HAVE BEEN PROGRAMMED FOR 50MG/ML.
DURING AN ELECTROPHYSIOLOGY PROCEDURE THIS DEVICE EXPERIENCED INTERMITTENT CONTINUTIY. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
ON 10/16/96, THE FACILITY'S SURGICAL MATERIALS SPECIALIST CONTACTED THE MFR'S MANAGER, PRODUCT COMPLAINTS & LITIGATION TO REPORT THAT THE DEVICE CATHETER HAD FRACTURED AND AS A RESULT, THE DEVICE WAS EXPLANTED ON 8/2/96. THE DEVICE CATHETER WAS SURGICALLY CUT INTO TWO PIECES AND THE SEGMENT OF CATHETER HAS A PARALLEL SLIT IN IT. THE FACILITY'S SURGICAL MATERIALS SPECIALIST WILL RETURN THE DEVICE FOR ANALYSIS AND REQUESTED A COPY OF THE ANALYSIS RESULTS.
ON 1/6/97, FACILITY'S SURGICAL MATERIALS SPECIALIST INFORMED A MFR REP THAT DUE TO SOME INTERNAL ISSUES AT FACILITY, DEVICE HAS NOT BEEN RETURNED TO MFR FOR ANALYSIS. ADDITIONALLY, FACILITY'S SURGICAL MATERIALS SPECIALIST STATED THAT TO HER KNOWLEDGE, IT IS NOT KNOWN WHEN/IF DEVICE WOULD BE RETURNED. MFR REP INFORMED FACILITY'S SURGICAL MATERIALS SPECIALIST THAT IN VIEW OF CURRENT SITUATION, MFR HAD NO CHOICE BUT TO CLOS FILE ON THIS EVENT; HOWEVER, SHOULD DEVICE AND OR FURTHER INFO BECOME AVAILABLE IN FUTURE, MFR WOULD REOPEN MFR'S INVESTIGATION OF THIS INCIDENT. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG/LOT NUMBE AND A TREND WAS NOT INDENTIFIED. A REVIEW OF DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT. BASED ON INFO AVAILABEL ANDDUE TO UNAVAILABILITY OF DEVICE, NO CONCLUSION CAN BE DRAWN AS TO CAUSE OF THIS EVENT. MFR'S INVESTIGATION OF THIS INCIDENT IS INCONCLUSIVE. NO FURTHER DETAILS ARE AVAILABLE. MFR IS CLOSING FILE ON THIS EVENT. H.11/. CORRECTED DATA 1) INITIAL MEDWATCH REPORT SUBMITTED ON 11/12/96, SECTION B.2, DATE OF THIS REPORT READ 11/12/96, IT SHOULD HAVE READ 10/16/96. 2) INITIAL MEDWATCH REPORT SUBMITTED ON 11/12/96, SECTION F.8., DATE OF THIS REPORT READ 11/12/96, IT SHOULD HAVE READ 10/16/96.
AN 18 Y/O WITH DIAGNOSIS OF CONGENITAL COMPLETE AV BLOCK, STATUS POST REVISION OF VENTRICULAR LEAD PRESENTED FOR FOLLOW-UP CARE WITH GENERALIZED SWELLING OF FACE, FEET AND HANDS. EKG RESULTS SUGGESTED THAT HER PACEMAKER WAS NOT FUNCTIONING PROPERLY. IT IS SUSPECTED THAT DURING INTERROGATION OF THE DEVICE WITH THE PROGRAMMING HEAD THAT THE DEVICE FUNCTIONS PROPERLY. HOWEVER, FOLLOWING INTERROGATION WITHOUT THE PROGRAMMING HEAD THE DEVICE BEGAN PACING IN A DUAL CHAMBER.
DURING EP STUDY, PHYSICIAN ATTEMPTING TO CHANGE SHEATH NOTED SHEATH KINKED. SHEATH BROKE UPON REMOVAL. PT TAKEN TO SURGERY FOR REMOVAL OF RETAINED PIECE. PT STABLE.
WHILE PERFORMING THE DAILY TEST, THE OPERATOR NOTED THAT WHEN THE DEFIBRILLATOR OUTPUT WAS SET TO 50 JOULES, THE ACTUAL OUTPUT WAS APPROX 400 JOULES. THERE WAS NO PT INVOLVED.
INVESTIGATION DETERMINED THAT A SCREW SECURING A HEAT SINK IN THE PORER SUPPLY HAD COME LOOSE. THE LOOSE HEAT SINK CAUSED TRANSISTORS Q4 & Q5 TO MAKE INTERMITTENT CONTACT, WHICH IN TURN CAUSED INTERMITTENT OUTPUT FROM THE 12 VOLT SUPPLY. THE CAUSE OF THE SCREW LOOSENING COULD NOT BE DETERMINED. A REVIEW OF SVC RECORDS INDICATES THAT THIS IS AN UNUSUAL OCCURRENCE AND NO ADD'L ACTION IS ANTICIPATED. THE EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.
AMBULANCE PERSONNEL WERE ATTENDING TO A PT SUFFERING FROM TRAUMATIC CARDIAC ARREST. AN ATTEMPT WAS MADE TO DEFIBRILLATE THE PT. ALLEGEDLY THE  DEFIBRILLATOR WOULD START TO CHARGE BUT WOULD INTERMITTENTLY DUMP THE ENERGY BEFORE REACHING FULL CHARGE. THE OPERATOR WAS ABLE TO SUCCESSFULLY DELIVER 5 SHOCKS TO THE PT, HOWEVER THE PT WAS NOT RESUSCITATED. THE REPORTER STATED THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THIS OPINION WAS BASED ON THE CLINICIAN'S ASSESSMENT OF THE PT'S VIABILITY AND THE ABILITY OF THE OPERATOR TO COUNTERSHOCK THE PT AS NECESSARY.
SUBSEQUENT TO SUBMISSION OF MEDWATCH REPORT, THE CUSTOMER MADE A DECISION TO NOT REPAIR THE DEVICE. THE UNIT WAS RETURNED TO THE CUSTOMER AS RECEIVED.
OVERDELIVERY REPORTED BY CO'S AFFILIATE. REPORT STATES: "PUMP HAS DELIVERED 5FU IN 3 HOURS INSTEAD OF 12 HOURS. THE PT DID NOT EXPEREIENCE ANY SIDE EFFECT". NO FUTHER INFO WAS AVAILABLE.
TESTING AND INVESTIGATION RECEIVED FORM CO. AN INFUSION TEST RAN AT 250 ML/H FOR A TOTAL OF 10 ML WITHIN SPECIFICATIONS.
THE PT WITH CHEMOTHERAPY-INDUCED HUS, END-STAGE CANCER OF COLON, RECEIVED HIS FIRST COLUMN TREATMENT ON 10/8/96. PROCEDURE STARTED WITHOUT INCIDENT. BLOOD PRESSURE (B/P_208/110. AFTER DIVERSION OF HEPARINIZED SALINE TO WASTE, TREATED PLASMA RETURNED TO PT AT 5,L/MN. AFTER 15 MINUTES THE RETURN RATE OF PLASMA TO PT WAS INCREASED TO 10ML/MN. B/P STABLE AT 166/99. APPROX 3 MINUTES  AFTER INCREASE IN PLASMA FLOW RATE, THE PT COMPLAINED OF ABDOMINAL FULLNESS AND THEN VOMITED. PROCEDURE STOPPED. BOLUS OF SALINE ADMINISTERED. PT FELT BETTER AFTER APPROX 5 MINUTES AND THE PROCEDURE WAS RESTARTED. AGAIN, WITHIN 2-3 MINUTES THE PT EXPERIENCED VOMITING. THE PROCEDURE AGAIN WAS STOPPED AND THE PT WAS GIVEN SALINE. THE PROCEDURE WAS RESTARTED WITYH REINFUSION RATE OF TREATED PLASMA AT 5ML/MN BUT THE PT WAS UNABLE TO TOLERATE DUE TO ANOTHER EPIDOSE OF VOMITING. PROCEDURE DISCONTINUED. PT RECEIVED 202CC OF TREATED PLASMA. B/P 170/100. THE PT HAS NO RENAL FUNCIOTN AND ES DIALYZED IMMEDIATELY AFTGER COLUMN THERAPY. THE PT WAS ON DIALYSIS FOR APPROX 2/5 HOURS AND THEN COMPLAINED OF ABDOMINAL CRAMPING AN NAUSEA. HE WAS UNABLE TO TOLERATE DIALYSIS FURTHER AND THE PROCEDURE WAS DISCONTINUED. THE PT UNDERWENT HIS SECOND COLUMN TREATMENT THE NEXT DAY, 10/9/96, AND AFTER APPROX 100 CC OF TREATED PLASMA HAD BEEN RETURNED, THE PT EXPERIENCED TIGHTNESS IN HIS CHEST. SHORTNESS OF BREATH, AND COMPLAINED OF NAUSEA. OXYGEN WAS ADMINISTERED. THE PROCEDURE WAS HALTED FOR A SHORT TIME AND THEN RESTARTED, BUT SYMPTOMS CONTINUED AND THE PROCEDURE WAS DISCONTINUED. THE PT WAS TO CONTINUE ON DIALYSIS AND HAVE A THERAPEUTIC PLASMA EXCHANGE ON 10/11/96. THE PT'S CLINICIAN ELECTED TO DISCONTINUE PLASMA EXCHANGE THERAPY ON 10/14/96. NO ADD'L COLUMN TREATMENTS PLANNED AT THIS TIME.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN THE DEVICE LABELING? N. IF NO, IS FREQUENCY GREATER FOR THIS EVENT THAN IS USUSAL? UNK.  IS SEVERITY OF OCCURRENCE OF THIS EVENT ADDRESSED TIN THE DEVICE LABELING? N. IF NO, IS SEVERITY GREATER FOR THIS EVENT THAN IS USUAL? UNK. MFR DID NOT RECEIVED A USER FACILITY REPROT FOR THIS EVENT.
DURING A PTCA PROCEDURE THE BALLOON OF THIS DEVICE RUPTURED REPORTEDLY CAUSING A BLOOD VESSEL TO EXPAND AND CONTRAST MEDIUM TO LEAK. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
DURING SVC OF PRODUCT A NO POWER CONDITION WAS FOUND AT POWER UP DUE TO AN INTERMITTENT ELECTRICAL CONNECTION.
UNDERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE AN IV CONATAINER WITH 185 ML OF AN UNSPECIFIED CHEMOTHERAPEUTIC AT 1.1 ML/HR OVER 7 DAYS. THE PT REPORTED THAT AT THE EXPECTED COMPLETION TIME, THE DEVICE HAD INFUSED ONLY 140 ML. ACCOUNT REPORTS THAT NO ALARMS SOUNDED DURING THE INFUSION PERIOD. THERE WERE NO ADVERSE PT EFFECTS.
AN INFUSION TEST USING CUSTOMER PROTOCOL OF 1.1 ML/HR RAN WITHIN SYSTEM SPECIFICATIONS. CO EXPECTED 75.5 ML AND MEASURED 74.33G% ERROR -5.52.
DURING THE PROCEDURE THE WIRE BROKE WHILE BEING TORQUED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVUCE IS BEING RETURNED FOR CO'S ANALYSIS.
PARAMEDICS USED THE DEVICE TO DELIVER A COUNTERSHOCK TO THE PT DIAGNOSED WITH A SHOCKABLE ARRYTHMIA. VARIOUS MEDICATIONS WERE ADMINISTERED TO THE PT, WHO CONTINUED TO BE UNRESPONSIVE. PACING THERAPY WAS ATTEMPTED AS A FINAL EFFORT AT RESUSCITATION. REPORTEDLY, WHEN THE PACER CURRENT WAS ADJUSTED TO 60MA, THE PACER SHUT OFF. THIS ALLEGATION WAS BASED UPON THE OBSERVATION THAT PACER START/STOP SWITCH HAD TO BE PRESSED AGAIN TO ADJUST CURRENT. THE PACER REPORTEDLY SHUT OFF WITH THE NEXT ATTTEMPT.
THE LOCAL CO SERVICE REPRESENTATIVE OBSERVED PROPER OPERATION OF THE DEVICES AND ATTACHED PACER CABLES, THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE FACILITY WAS PROVIDED WITH A REVIEW OF DEVICE PACER OPERATION BY THE REPRESENTATIVE. THE DEVICE WERE RETURNED TO THE FACILITY FOR USE.
DURING THE PROCEDURE UPON INJECTION A HOLE WAS DETECTED IN THE SHAFT OF THE CATHETER. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
REORT OF ALLEGED "NO APNEA ALARM. FOUND DURING BENCH TEST".
LABELING #1738 TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL.
SET FELL APART AT SEAM WHILE UNDER PRESSURE. CUSTOMER WAS OPERATING HYPERBAIC CHAMBER AT 45FT BELOW SEAWATER AND WERE INFUSING DEXTRAN TO A MALE IN HIS 20'S WITH A SKINFLAP. WITHIN THE FIRST 30 MINUTES OF TREATMENT THE TUBING DETACHED FROM THE PASS THROUGH CONNECTION RESULTING IN THE INFUSION BEING DISCONTINUED. WERE THEN UNABLE TO INFUSE MEDICATION INTO CHAMBER. NURSE ASKED THE PT TO CLAMP THE TUBING FROM INSIDE BUT, HE DID NOT SPEAK ENGLISH AND THERE WAS NO INTERPRETER AVAILABLE. NURSE FELT THAT THE TREATMENT WAS TOO IMPORTANT TO INTERRUPT. PT SUFFERED NO ADVERSE SEQUELAE.
EXAMINATION OF THE EIGHT RETURNED SEALED SETS SUBMITTED FOR EVALUATION REVEALED SECURE TUBING ATTACHMENTS TO THE HYPERBARIC DOOR ADAPTER ON EACH PRESSURE TESTING OF EACH OF THE SETS TO 8 P.S.I.G. IN ACCORDANCE WITH SPECS REVEALED NO LEAKAGE. COULD NOT DUPLICATE THE REPORTED COMPLAINT CONDITION.
DURING THE PROCEDURE THE VALVE OF THIS DEVICE LEAKED. THE DEVICE WAS REMOVED AND REPLACED. THERE IS NO REPORT OF PT INJURY. THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
REVISION OF MALFUNCTIONING PENILE PROSTHESIS. R CYLINDER HAD SIGNIFICANT LEAK AT ITS BASE.
DURING SVC OF PRODUCT DEVICE WAS FOUND TO NOT CYCLE WITH ALL LEDS AND CONSTANT SINGLE TONE ALARM, DUE TO LIQUID SPILL ON LOGIC BOARD AND MOTOR BOARDS.
H-6 100-FAILURE CAUSED BY LIQUID SPILL ON LOGIC AND MOTOR BOARDS. LABELING-1738.
DURING THE PROCEDURE THE GASKET OF THIS DEVICE DISLODGED. THE DEVICE WAS REMOVED AND REPLACED. THERE IS NO REPORT OF PT INJURY. THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
PARAMEDICS USED THE DEVICE TO DIAGNOSE A PT AS ASYSTOLIC. PACING THERAPY WAS ATTEMPTED AS A FINAL EFFORT AT RESUSCITATION. REPORTEDLY, WHEN THE PACER CURRENT WAS ADJUSTED, THE PACER SHUT OFF. THE DEVICE OPERATOR DID OBSERVE THE DEVICE EMIT AN AUDIBLE BUT UNSPECIFIED TONE AT THIS TIME. THE PACER START/STOP SWITCH HAD TO BE PRESSED AGAIN TO ADJUST CURRENT. THE PACER REPORTEDLY SHUT OFF WITH THE NEXT ATTEMPT.
THE LOCAL CO'S SERVICE REPRESENTATIVE OBSERVED PROPER OPERATION OF THE DEVICES AND ATTACHED PACER CABLES, THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE FACILITY WAS PROVIDED WITH A REVIEW DEVICE PACER OPERATION BY THE REPRESENTATIVE. THE DEVICES WERE RETURNED TO THE FACILITY FOR USE.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE NORMAL SALINE WITH 20 MEQ POTASSIUM CHLORIDE/1000 ML AT 75 ML/HR VIA PRIMARY. THE IV CONTAINER WAS EMPTY AFTER 3.5 HOURS OF INFUSION TIME. THE EXPECTED DELIVERY AMOUNT AT THAT TIME WAS APPROX 262 ML. THE PT DID NOT EXPEREIENCE ANY ADVERSE EFFECTS. A SECOND SCHEDULED CONTAINER OF IV FLUIDS WAS WITHHELD PER PHYSICIAN ORDER. THE ACCOUNT BIOMEDICAL ENGINEERING DEPT REPORTS THAT WHEN THE DEVICE WAS RECEIVED BY THEM, IT WAS SET TO DELIVER AT 75 ML/HR VIA PRIMARY AND AT 200 ML/HR VIA SECONDARY. IT INDICATED DELIVERY OF 1238 ML, WITH A VOLUME TO BE INFUSED OF 994 ML ON THE PRIMARY SIDE AND 0 ML TO BE INFUSED ON THE SECONDARY SIDE. THE PUMP DELIVERED ACCURATELY DURING BIOMED TESTING.
THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE FREQUENCY OF DEATH OR SERIOUS INJURY FOR CODE 102 (OVERDELIVERY) FOR PRODUCTS IS APPROX 0.21/MILLION SETS.
DURING THE PROCEDURE THE VALVE OF THIS DEVICE LEAKED PROFUSELY. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE. THE DEVICE IS NOT BEING RETURNED FOR CO'S ANALYSIS.
THE DEVICE WAS IMPLANTED ON 10/05/96 FOR SUBCLAVIAN INFUSION OF CHEMOTHERAPY. ON 10/15/96, THE FACILITY NURSE REPORTED THAT ON 10/13/96, FLUID WAS NOTED AROUND THE INSERTION SITE ON THIS PT; HOWEVER, THE PT DID NOT COMPLAIN OF ANY DISCOMFORT. THE DEVICE WAS THEN HEPARIN LOCKED. ON 10/14/96, THE DEVICE WAS ACCESSED WITH A 1-1/2" NEEDLE AND A BLOOD RETURN OF 10CC WAS OBTAINED AND THEN STOPPED. AN INCREASE IN LEAKING WAS NOTED. A DYE STUDY WAS PERFORMED AND REVEALED THE TIP OF THE DEVICE CATHETER WAS TOTALLY OCCLUDED WITH DYE COMING OUT OF THE DEVICE CATHETER FURTHER UP FROM THE TIP WHEN EITHER OF THE TWO DEVICE SEPTA WERE ACCESSED. THE FACILITY NURSE REPORTED THAT THIS IS THE 2ND TIME THIS HAD OCCURRED IN LESS THAN TWO MONTHS. THE FACILITY NURSE ALSO STATED THAT SHE SOMETIMES USES 5CC SYRINGES FOR THE HEPARIN LOCK PROCEDURE AND ALSO USES 30CC AND 50CC SYRINGS FOR ADRIAMCYIN ADMIN. THE DEVICE HAD BEEN SCHEDULED FOR EXPLANT. THE MFR NURSE THEN DISCUSSED SYRINGE SIZE AND PSI, FLUSHING VS HEPARIN LOCK PROCEDURE, USEFULNESS OF DYE STUDIES TO DETERMINE DEVICE CATHETER PLACEMENT IN A ONE WAY OCCLUSION, AND THE USE OF UROKINASE FOR FIBRIN SHEATHS.
ON 10/17/96, THE FACILITY NURSE REPORTED THAT THIS PT'S CIRCUMSTANCES HAD "CHANGED DRASTICALLY" IN THE LAST TWO DAYS. THE PHYSICIAN HAS NOW DECIDED NOT TO EXPLANT THE DEVICE AT THIS TIME AND THEY ARE GOING TO BE DISCONTINUING CHEMOTHERAPY TREATMENTS. THE FACILITY NURSE STATED THAT THE PT IS ENTERING THE "FINAL PHASE" AND IS TERMINAL AND "HAD NOT REALLY BEEN A GOOD CANDIDATE FOR THIS THERAPY". IN ADDITION, TH EFACILITY NURSE STATED THAT SHE IS ABLE TO OBTAIN A BLOOD RETURN FROM THE MEDIAL LUMEN OF THE DEVICE AND WILL CONTINUE TO USE THE DEVICE AS A SINGLE LUMEN FOR IV PURPOSES. THE FACILITY NURSE ALSO STATED THAT THEY PLANNED TO UROKINASE BOTH LUMENS OF THE DEVICE; HOWEVER, IF THEY SHOULD EXPERIENCE DIFFICULTIES USING THE DEVICE IN THIS MANNER (AS AN IV), THEN THEY WILL JUST DISCONTINUE ITS USE ALL TOGETHER AND "MOST LIKELY WILL NOT EXPLANT THE DEVICE". SINCE THE DEVICE WILL REMAIN IMPLANTED AT THIS TIME, THE MFR'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS ON THIS CATALOG NUMBER. A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CATALOG NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. A LOT NUMBER WAS OT AVAILABLE FOR THIS DEVICE; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFO AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS. NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
IT HAS BEEN REPORTED TO CO THAT DURING THE PROCEDURE THE VALVE OF THIS DEVICE LEAKED PROFUSELY. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE. THE DEVICE IS NOT BEING RETURNED FOR CO'S ANALYSIS.
PT HAD PORT IMPLANTED ON 9/25/92. ON 8/19/96, THE PT WAS ADMITTED FOR NECK AND SUPRA CAVA SWELLING AND SHORTNESS OF BREATH. CT SCAN REVEALED EXTENSIVE THROMBOSIS IN THE SUPERIOR VENA CAVA AND LEFT BRACHIAL CEPHALIC VEIN AROUND THE CATHETER. PHYSICIAN NOTES STATE THAT PORT FLUSHED INTERMITTENTLY.
DURING A VITRECTOMY PROCEDURE, THE VITRECTOMY CUTTER WAS FUNCTIONING INTERMITTENTLY.
DURING A CATARACT EXTRACTION PROCEDURE, THIS BIPOLAR CORD STOPPED WORKING. ANOTHER CORD WAS USED TO COMPLETE THE PROCEDURE.
A 58-YR-OLD FEMALE WITH HISTORY OF VALVE IMPLANTATION FROM 1982. MITRAL WITH PREVIOUS HISTORY OF 2 MITRAL VALVE COMMISSUROTOMIES IN ANOTHER CITY. PT DID WELL UNTIL A FEW MONTHS AGO WHEN DEVELOPED SHORTNESS OF BREATH, MORE RECENTLY IN CONGESTIVE FAILURE AND BILATERAL EFFUSIONS. ECHOCARDIOGRAM AND CARDIAC CATH PERFORMED REVEALED SIGNIFICANT GRADIENT ACROSS MITRAL VALVE PROSTHESIS AS WELL AS SIGNIFICANT LESIONS IN THE LAD AND RIGHT CORONARY ARTERY. CONSIDERED IN A VERY FRAGILE CONDITION PRIOR TO THIS PROCEDURE ON 10/21/96. PT DID HAVE PROCEDURE. POST OPERATIVE COURSE NOT SMOOTH. AS OF 11/1/96, PT OUT OF INTENSIVE CARE, WITH A PERM PACEMAKER NOW IN PLACE. DEVICE BEING RETURNED TO CO. THIS REPORT WAS LATE DUE TO PROGAM TROUBLE.
DURING AN INFERIOR ALVEOLAR (RIGHT MANDIBULAR BLOCK) INJECTION IN THE PT'S LOWER JAW BEHIND THE SECOND MOLAR, DR FELT SOME PUSH ON THE BONE AND WHILE ATTEMPTING TO PULL OUT THE NEEDLE, IT SEPARATED FROM THE HUB. NEEDLE WAS SURGICALLY REMOVED WITHOUT COMPLICATION.
THE HUB OF THE NEEDLE USED WAS DISCARDED BY THE PRACTITIONER. THE DR'S INSURANCE CARRIER HAS THE NEEDLE FRAGMENT. DR STATED WHE DISCONTINUED THE USE OF A 30G NEEDLE FOR THIS TYPE OF PROCEDURE.
REPORT OF A ALLEGED AUDIBLE ALARM DOES NOT FUNCTION, CONTINUOUS SETTING ERROR. NO PT HARM. FOUND DURING BENCH TEST.
TESTING BY MFR FOUND A NO AUDIBLE ALARM CONDITION, WITH CONTINUOUS SETTING ERROR LED, DUE TO AN INTERMITTENT ELECTRICAL CONNECTION. [LABELING-#1738.]
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFIACTION HANDPIECE COULD NOT BE CALIBRATED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
REPORT OF ALLEGED "UNIT WON'T CYCLE, WITH ALL LEDS ON, CONSTANT SINGLE TONE ALARM. NO PT HARM".
TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL. LABELING-1738.
UNREQUESTED/SELF DELIVERY REPORTED. THE PUMP WAS IN USE INFUSING MEPERIDINE 10MG/ML WITH A PCA DOSE OF 10MG, A 10 MINUTE PT LOCKOUT AND 100MG 4 HOUR LIMIT. NURSE REPORTS THAT THE DEVICE DELIVERED WITHOUT REQUEST ON TWO OCCASIONS WHEN BRUSHED BY THE PT'S COVERS, AND ONCE WHEN THE CORD WAS BEING MOVED TO THE BEDSIDE RAIL. THE PUMP DELIVERED WITHIN PROGRAMMED LOCKOUT AND 4 HOUR LIMIT PARAMATERS. THE 3 UNREQUESTED BOLUS DOSES DID NOT CAUSE ANY ADVERSE PT EFFECTS, THE PT WAS COMFOTABLE WITHOUT ANY SIGNS OF SEDATION. THE PUMP WAS SWITCHED OUT AND THE MEPERIDINE INFUSION CONTINUED WITH A NEW PUMP.
ACCOUNT REPORTS THEIR TESTING REVEALED A BOLUS CORD PROBLEM. BIOMEDICAL ENDGINEERING STATES THEY CONFIRMED A SHORT CIRCUIT WHEN THE CURRENT OVER THE PENDANT CONNECTION WAS TESTED. A NEW PENDANT TESTED FINE, AND THE DEVICE PERFORMED CORRECTLY WITH THE NEW PENDANT. THE DEFECTIVE PENDANT WAS DISCARDED, AND THE PUMP WAS RETURNED TO PT USE.
AFTER THE PORT WAS IMPLANTED, THE NEEDLE PIERCED THE "MEMBRANE" AND THE PLASTIC BASE OF THE PORT. BLEEDING FOLLOWED, AND THE PORT WAS REMOVED.
RETURNED FOR EVALUATION IS A PLASTIC PORT WITH ATTACHABLE 6.6 FR OPEN-ENDED CATHETER. THE CATH-LOCK IS NOT PRESENT. THE CATHETER TUBING IS DAMAGED AT THE PORT STEM, EXPOSING THE STEM TIP, BUT IS STILL CONNECTED. THE TUBING IS NICKED AND TORN. THERE IS BLOOD RESIDUE ON THE TUBING EXTERIOR AT THE DAMAGED AREA. THE DISTAL TIP OF THE CATHETER HAS BEEN CUT DIAGONALLY, DISTAL TO THE 4CM DEPTH MARK. THIS IS COMMONLY DONE BY THE USER TO IDENTIFY THE DISTAL TIP. THE OVERALL LENGTH OF THE PORT/CATHETER ASSEMBLY IS 8.75". THE CATHETER IS CONNECTED AND GOUGES ON THE HARD PLASTIC EXTERIOR OF THE PORT, WITH GRIP MARKS FROM A SERRATED JAWED INSTRUMENT ON  THE BASE PERIMETER. THERE ARE SEVERAL NEEDLE STICK MARKS IN THE SILICONE SEPTUM. THERE ARE TINY PROTRUSIONS NEAR THE CENTER OF THE UNDERSIDE OF THE HARD PLASTIC BOTTOM, OUTLINED WITH BLOOD RESIDEUE. THE PORT RESERVOIR IS DARKENED WITH BLOOD RESIDUE. THE DAMAGED CATHETER TUBING IS VIEWED UNDER MAGNIFICATION. THE TUBING HAS BEEN NICKED AND TORN. THERE ARE IMPRESSIONS FROM THE CATH-LOCK AND FROM A SERRATED JAWED GRIPPING DEVICE, SUCH AS HEMOSTATS. SINCE NO SUBCUTANEOUS BREAKAGE OR LEAKAGE IS INDICATED BY THE USER, MOST OF THE DAMAGE PROBABLY OCCURRED AFTER EXPLANTATION WHEN THE CATH-LOCK WAS RETRACTED FROM THE PORT STEM. THIS IS INTENDED TO BE A SEMI-PERMANENT CONNECTION. THE PORT ASSEMBLY IS ACCESSED AND FLUSHED WITH A 22 GA NON-CORING NEEDLE ATTACHED TO A 12 CC SYRINGE FILLED WITH WATER. WATER LEAKS FROM THREE PROTRUSIONS IN THE PORT BASE. WITH FINGER PRESSURE APPLIED TO THESE HOLES, THE PORT LUMEN IS VERIFIED TO BE PATENT AS WATER EXITS TEH STEM OPENING. THE NEEDLE IS THEN INSERTED INTO THE OPENING OF THE DISTAL TIP OF THE CATHETER. WATER IS FLUSHED BACK THROUGH THE TEAR AT THE STEM, VERIFYING CATHETER LUMEN PATENCY. UNDER MAGNIFICATION, THE HOLES APPEAR TO BE TINY ERUPTIONS IN THE PLASTIC FROM THE INSIDE OF THE RESERVOIR. THE HOLES ARE SEMI-CIRCULAR IN SHAPE. THESE OUTWARD PROTRUSIONS ARE TYPICAL OF NEEDLE DAMAGE. WHEN EXCESSIVE FORCE IS USED, THE NEEDLE TIP CAN BE FORCED THROUGH THE HARD PLASTIC BASE. A FORCE OF 25 POUNDS OR GREATER IS REQUIRED TO PERFORATE THE RESERVOIR WALL. THIS IS MUCH GREATER THAN THE 1 TO 2 POUNDS FORCE REQUIRED TO PIERCE THE SILICONE SEPTUM.
THIS INFO IS BEING SUBMITTED AS A 30 DAY MFRS REPORT. THIS EVENT HAS BEEN PREVIOUSLY SUBMITTED AS A 10 DAY DISTRIBUTOR REPORT. THIS DEVICE WAS NOT EXPLANTED. THE SURGEON'S NURSE REPORTED THAT THE SURGEON'S NOTES STATED THAT THE ENOG TESTING SHOWED NO FACIAL NERVE FUNCTION ON THE IMPLANT SIDE. THE SURGEON DOES NOT PLAN ANY INTERVENTION AT THIS TIME. THE PT'S ETIOLOGY OF HEARING LOSS WAS EXTENSIVE HEAD TRAUMA AS A RESULT OF BEING HIT BY A TRAIN.
WHILE PTA OF RIGHT RENAL ARTERY WAS BEING PERFORMED THE STENT WAS PLACED AND A BALLOON WAS DEPLOYED. THE BALLOON GOT STUCK IN THE STENT, DID NOT UNWRAP CORRECTLY AND SUBSEQUENTLY BROKE. MULTIPLE ATTEMPTS WERE MADE WITH THE SNARE TO RETRIEVE THE BALLOON HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. PT WAS TAKEN TO OR FOR RIGHT RENAL ARTERY EXPLORATION THROUGH THE RIGHT SUBCOSTAL INCISION WITH REMOVAL OF RETAINED PIECE OF BALLOON, RIGHT RENAL THROMBECTOMY AND HEPATORENAL BYPASS WITH REVERSE SAPHENOUS VEIN GRAFT.
IT WAS REPORTED THAT ON 10/8/96, A PT INTUBATED WITH A TUBE EXPERIENCED SEVERE RESPIRATORY DISTRESS AND REQUIRED EMERGENCY MEDICAL INTERVENTION. THE DEVICE WAS EXTUBATED. MULTIPLE ATTEMPTS TO REINTUBATE THE PT WERE INITIALLY UNSUCCESSFUL. PT WAS EVENTUALLY INTUBATED WITH A ENDOTRACHEAL TUBE. AFTER ESTABLISHING PT'S VITAL SIGNS PT WAS DIAGNOSED AS NEUROLOGICALLY IMPAIRED. SUPPORT WAS WITHDRAWN AND DEATH DECLARED 10/10/96. IN FOLLOW-UP PHONE CONVERSATION IT WAS REPORTED THAT THE DEVICE WAS OBSERVED TO BE "KINKED" AND THAT PT EXPERIENCED SEVERE BRONCHOSPASMS WHICH PREVENTED MULTIPLE ATTEMPTS TO RE-INTUBATE. IT WAS ALSO REPORTED THAT ATTENDING MEDICAL STAFF WERE UNABLE TO MANUALLY VENTILATE THE PT WHEN THE BAG EXHALATION FUNCTIONALITY FAILED TO FUNCTION PROPERLY. THE DEVICE WAS IN USE FOR FOUR DAYS AND FUNCTIONED AS EXPECTED WITH NO REPORTED PROBLEMS. REPORTER DOES STATE THAT PT HAD HEAVY SECRETIONS AND REQUIRED SUCTIONING EVERY HOUR. THE ATTENDING DR'S INITIAL INVESTIGATION INDICATES THAT PT MAY HAVE DEVELOPED A MUCOUS PLUG WHICH OBSTRUCTED THE AIRWAY. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN TO THE MFR FOR ANALYSIS AND INVESTIGATION.
THERE WAS ONE PT INVOLVED. INFO FOUND IN SECTION F ON THIS REPORT IS COPIED FROM THE USER FACILITY REPORT. EVENT FREQUENCYI IS NOT ADDRESSED IN PRODUCT LABELLING. EVENT IS NOT OCCURRING MORE FREQUENTLIY THAN USUAL FOR PRODUCT. EVENT SEVERITY IS NOT ADDRESSED IN PRODUCT LABELLING. EVENT IS NOT OCCURRING WITH GREATER SEVERITY THAN USUAL FOR PRODUCT. THE MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTIETUTE AN AADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
DEVELOPED PSEUDOPHAKIC BULLOUS KERATOPATHY NECESSITATING PENETRATING KERATOPATHY.
REPORT OF ALLEGED "INTERMITTENT PROBLEMS, WILL NOT POWER UP OR CYCLE. NOT IN PT USE."
TESTING BY MFR FOUND A CONTINUOUS CYCLE IN ONE DIRECTION, NO VOLUME DELIVERED, WITH AUDIBLE LOW PRESSUE ALARM, DUE TO TRANSISTOR Q12 ON THE MOTOR BOARD BEING OUT OF SPEC. REPLACE Q12. LABELING-1738.
TWO MYOCARDIAL LEADS WERE REMOVED FROM SERVICE DUE TO NOISE IN THE SYSTEM. DURING A ROUTINE REPLACEMENT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THE PHYSICIAN ELECTED TO REPLACE THE LEADS, BECAUSE THE NOISE, AND IMPLANT A NEW SENSING LEAD.
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO UNABLE TO DRAW CONCLUSION FROM THE AVAILABLE INFO ON INAPPROPRIATE SHOCKS. NO FURHTER INFO IS AVAILABLE.
IRIS PLANE IOL WHICH CAME IN INTERMITTENT CONTACT WITH CORNEA. PT DEVELOPED PSEUDOPHAKIC BULLOUS KERATOPATHY (PBK) NECESSITATING PENETRATING KERATOPLASTY.
THE PORT WAS PLACED ON 2/29/96 FOR CHEMOTHERAPY. ON 05/15/96, IT WAS NOTED THAT 4/12" OF CATHETER HAD BROKEN OFF AND EMBOLIZED TO THE LEFT SIDE OF THE HEART. THE PORT/CATHETER UNIT AND THE FRAGMENT WERE REMOVED ON 5/21/96.
THE DEVICE IS CURRENTLY IN THE POSSESSION OF THE PT AND HAS NOT BEEN RETURNED TO THE MFR FOR EVAL.
CUSTOMER REPORTED EXPERIENCING SEVERAL INCIDENTS OF LEAKAGE AT THE CASSETTE DURING USAGE. NO PT INJURY WAS REPORTED. NO FURTHER INFO IS AVAILABLE.
SECTION 10A AND B. AS A RESULT OF REGULATION CHANGES EFFECTIVE 7/31/96, THIS SECTION NO LONGER APPLIES. *A, B6, B7, H4, AND H8 UNK. ATTEMPTED TO GET MORE DETAILS 10/8. H3, LAB EVAL CONFIRMED THE SETS TO LEAK FROM A SPLIT IN THE CASSETTE FILM AT THE INLET VALVE. THE LEAKAGE OCCURS AFTER CONTINUOUS USE IN THE PUMP; HOWEVER, THE PROBLEM IS NOT WITH THE PUMP, BUT WITH THE SET. THE CASSETTE'S SILICONE RUBBER INLET TUBING HAS BEEN OBSERVED TO MOVE WHILE IN USE. THIS HAS BEEN FOUND TO OCCUR ONLY ON THE CASSETTE AUTOMATED ASSEMBLY PROCESS. IMMEDIATE ACTION HAS BEEN TAKEN TO RESTRICT THE MANUFACTURING PROCESS TO THE MANUAL PROCESS ONLY. IN ADDITION, IMPROVEMENTS TO THE MATERIAL AND AUTOMATED PROCESS HAVE BEEN DEVELOPED. A PRODUCT ADVISORY IS BEING FORWARDED TO CUSTOMERS 10/96.
TWO MYOCARDIAL LEADS WERE REMOVED FROM SERVICE DUE TO NOISE IN THE SYSTEM DURING A ROUTINE REPLACEMENT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE PHYSICIAN ELECTED TO REPLACE THE LEADS, BECAUSE OF THE NOISE, AND IMPLANT A NEW SENSING LEAD.
POST-OPERATIVE CYSTOID MACULAR EDEMA POSSIBLY RELATED TO IOL. PENETRATING KERATOPLASTY REQUIRED.
TEE DURING IMPLANT PROCEDURE INDICATED CENTRAL INSUFFICIENCY. THE SURGEON NOTED THAT IT LOOKED LIKE THE SMALL LEAFLET WAS NOT ABLE TO CLOSE. THE VALVE WAS REMOVED AND AN SMALLER VALVE WAS IMPLANTED.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTIN REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMACE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." A MEDWATCH FORM ON THIS EVENT WAS NOT RECEIVED FROM THE USER FACILITY. THEREFORE CO COMPLETED THE FORM WITH INFO FROM THE MD. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FORM 3500A." ANALYSIS IS NOT YET COMPLETE AND WILL BE SENT ON FOLLOW-UP WHEN COMPLETED.
REPORT OF ALLEGED "SINGLE TONE ALARM, ALL LEDS ON, STOP CYCLE. NOT IN PT USE."
TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL. EVIDENCE OF LIQUID SPILL. [LABELING-#1738]
THE LEAD HAS BEEN CAPPED AND REMAINS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CO IS UNABLE TO DRAW CONCLUSION FOR THE AVAILABLE INFO ON SENSING INTERMITTENTLY.
REPORT OF ALLEGED "STOPPED GIVING BREATHS. NO PT HARM".
TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL. [LABELING #1738]
CUSTOMER NOTED FLUID AND BLOOD COMING FROM AIR VENT PORT AT THE BOTTOM OF THE FIBER BUNDLE DURING THE CASE.
THE RETURNED OXYGENATOR WAS TESTED FOR LEAKS; NO LEAKAGE WAS OBSERVED. SALINE WAS CIRCULATED THROUGH THE DEVICE FOR 1 HOUR AT MAXIMUM FLOW RATE; NO ABNORMALITY WAS OBSERVED. BOVINE BLOOD WAS THEN RECIRCULATED THROUGH THE DEVICE FOR 4 HOURS; NO ABNORMALITY WAS OBSERVED. NO CAUSE FOR THIS INCIDENT COULD BE IDENTIFIED.
ONE DEVICE WAS RETURNED BY THE DISTRIBUTOR. ACCORDING TO THE REPORTER, THE DEVICE WAS TESTED SEVERAL TIMES. THIS IS STANDARD PROCEDURE FOR THE AMBULANCE SERVICE. THEY DID NOT KNOW HOW MANY TIMES THE TUBE HAD BEEN TESTED BEFORE IT WAS FOUND TO HAVE A LEAK. THE TUBE IS STILL BEING EVALUATED AT CO'S MFG FACILITY. FURTHER INFO WILL BE FORWARDED AS SOON AS IT BECOMES AVAILABLE.
THREE TUBES RETURNED. RESULTS OF INVESTIGATION: DEVICE IN QUESTION WAS RETURNED IN ITS COMPLETE PACKAGING. DISTAL CUFF WAS FULLY FUNCTIONAL. LATEX CUFF, HOWEVER, RAPIDLY LEAKED UPON INFLATION. VISUAL EXAMINATION OF LATEX SHOWED SIGNS OF DEGRADATION AND AT PROXIMAL SHOULDER, LATEX WAS DELAMINATED IN SEVERAL AREAS, CULMINATING IN HOLES IN CUFF. THIS DAMAGE IS CHARACTERISTIC OF WHAT OCCURS AS A RESULT OF USING A COMMERCIAL GRADE SILICONE SPRAY ON LATEX; SOLVENT IN SPRAY ATTACKS LATEX CAUSING IT TO DEGRADE. NO OTHER ANOMALIES WERE DETECTED. PRODUCTION RECORDS WERE REVIEWED; NO DEVICES WITH HOLES IN LATEX CUFF WERE FOUND DURING 100% FOUR HOUR INFLATION SYSTEM TEST PERFORMED AT FINISHED DEVICE INSPECTION. ALSO, CUFF WALL THICKNESS WAS CHECKED AT INCOMING INSPECTION AND THICKNESS WAS WELL WITHIN SPECIFICATION. ONE RETAINED UNIT WAS FOUR HOUR LEAK TESTED AND FOUND FULLY FUNCTIONAL. A COMPLAINT FILE REVIEW SHOWED NO PRIOR COMPLAINTS INVOLVING THIS DEVICE LOT OR LATEX CUFF LOTS. COMMENTS AND CORRECTIVE ACTION: BASED ON INFO AVAILABEL AND EXAMINATION RESULTS, IT IS CONCLUDED THAT CUFF DAMAGE WAS CAUSED BY USER BY SPRAYING CUFF WITH A SILICONE LUBRICANT; NO MFG ERROR HAS OCCURRED. IT SHOULD BE NOTED THAT USE OF SILICONE SPRAY IS NOT WARNED ABOUT IN LABELING BECAUSE COMMERCIAL GRADE SILICONE SPRAY IS TOXIC TO PT AND HAS ONLY BEEN USED WITH MANNEQUINS. IT IS RECOMMENDED THAT VEGETABLE OIL SPRAY, INSTEAD OF SILICONE, BE USED TO AID IN PLACEMENT OF DEVICE MANNEQUIN. NO FURTHER INOF IS ANTICIPATED FOR THIS REPORT.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE. THE BALLOON WAS REMOVED WHILE INFLATED. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS CONFIRMED THE DEFLATION DIFFICULTIES. EXAM OF THE RETURNED CATHETER REVEALED A KINK IN THE INFLATION LUMEN. THE KINK MAY HAVE RESTRICTED FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE SHAFT DAMAGE COULD NO BE DETERMINED.
ADDITIONAL INFORMATION WAS RECEIVED ON 2/3/97.
CULTURE RESULTS WERE REPORTED TO BE STAPHYLOCOCCUS AUREUS (PREVIOUSLY REPORTED AS STAPHYLOCOCCUS EPIDERMIDIS). PATIENT OUTCOME IS REPORTED TO BE FAVORABLE.
IT WAS REPORTED TO CO THAT THE OPERATOR TRAPPED HER FINGER BETWEEN THE TUBE AND HORIZONTAL ARM DURING A PROCEDURE. APPARENTLY THIS RESULTED IN A FRACTURED FINGER. THE DEVICE WAS INSPECTED AND PLACED BACK IN SERVICE.
PT HAS A DACRON BYPASS FROM THE FRMORAL TO THE POLITAC. THE GRAFT WAS OCCLUDED CO THE SURGEON WANTED OT DO A THROMBECTOMY WITH A ADHERENT CLOT CATHETER. IN THE DISTAL PART OF THE GRAFT THE TIP BROKE OFF THE CATHETER AND STAYED TOGETHER WITH THE LATEX IN THE PT. UPON RE-OPERATION, THE TIP WAS EASILY REMOVED AND THE GRAFT THROMBECTOMY WAS SUCCESSFULLY PERFORMED.
SUBJECT DEVICE WAS APPLIED IN A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON 9/21/91. THE ORIGIANL PROCEDURE WAS COMPLETED WITHOUT INCIDENT. SOMETIME POST-OPERATIVELY THE PT COMPLAINED OF ABDOMINAL DISCOMFORT. A DIAGNOSTIC LAPAROSCOPY WAS PERFORMED ON 10/2/96. THE SURGEON OBSERVED THE KNIFE BLADE FROM THE ORIGINAL PROCEDURE INBEDDED IN THE PT'S PERITONEUM. THE COMPONENT WAS RETRIEVED WITHOUT INCIDENT.
11/8/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. THERE IS EVIDENCE ON THE KNIFE BLADE THAT INDICATES IT WAS WELDED TO BLUE PRINT SPECS. IT CAN BE SPECULATED THAT THE KNIFE BLADE DISENGAGEMENT WAS CAUSED BY THE SAME OBSTRUCTION THAT CAUSED THE KNIFE DAMAGE; HOWEVER, WITHOUT THE REMAINING KNIFE SHANK AND THE DISPOSABLE LOADING UNIT TO EVALUATED IT CANNOT BE RELIABLE DETERMINED.
RESIDENT HAD A PICC LINE INSERTED AT HOSP AND ADMITTED TO LTC FACILITY. THE RESIDENT WAS RECEIVING PT WHEN INCIDENT OCCURRED. IT WAS REPORTED BY PT THERAPIST THAT DURING UTILIZATION OF A LIFT THE PT'S PICC LINE WAS SNAPPED/FRACTURED.
UPON INSERTION THE SHEATH KINKED, THE LOT NO WAS NOT REPORTED. A SECOND INTRA-KIT WAS OPENED AND THE HEMOSTASIS VALVE WAS FOUND TO BE MISSING. NO LOT# WAS AVAILABLE A THIRD INTRO KIT WAS THEN OPENED AND UTILIZED SUCCESSFULLY.
H-11-ALL UNK INFO REQUESTED BUT NOT RECEIVED. H-11-SECTION F PROVIDED BY MFR. H-10 SECTION H3 CODE 81 HOSP NOT RETURNING SAMPLE DISCARDED.
THE CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS CORE ASSAY, THE SAMPLE HANDLER, SERIAL NUMBER 1908, MISREAD A SAMPLE BARCODE LABEL AS "000FC79073." NO ERROR MESSAGE WAS SGENERATED. THE BARCODE LABEL IN QUESTION IS EXPECTED FOR INVESTIGATION. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS APPLIED TO THE CYSTIC DUCT. AFTER FIRING THE INSTRUMENT COULD NOT BE REMOVED. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE TO REMOVE THE DEVICE.
11/8/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. CO FOREIGN SUBSIDARY WAS INFORMED OF THIS EVENT ON 9/25/96; HOWEVER, CORPORATE WAS NOT INFORMED UNTIL 10/29/96. CO FOREIGN SUBSIDARY WILL BE REINSTRUCTED REGARDING THE STATUTORY REPORTING REQUIREMENTS OF THE MDR REGULATION.
UNIT SENT IN FOR PREVENTIVE MAINTENANCE. DURING MAINTENANCE CHECK, UNIT DISPLAYED ERROR CODE 001.
EVAL SUMMARY: FOUND POWER MOS FET (Q1) ON HIGH VOLTAGE BOARD TO BE SHORTED GATE TO DRAIN. REPLACED Q1. UNIT FUNCITONS CORRECTLY. MATRX MEDICAL INC. DOES NOT CONSIDER THIS DOCUMENT OR ITS CONTENTS TO BE AN ADMISSION THAT A MATRX PRODUCT HAS CAUSED A DEATH OR SERIOUS INJURY. THIS DOCUMENT CONTAINS COFIDENTIAL OR PROPIETARY INFORMATION OF MATRX. NEITHER THIS DOCUMENT NOR THE INFORMATION THEREIN IS TO BE REPRODUCED, DISTRIBUTED, USED OR DISCLOSED, EITHER IN WHOLE OR IN PART EXCEPT AS SPECIFICALLY AUTHORIZED BY MATRX MEDICAL INC.
10/7/96 PERMANENT PACEMAKER IMPLANTED. 10/8/96 RETURNED TO CATH LAB DUE TO MICRO-DISLODGEMENT OF VENTRICULAR LEAD. LEAD WAS REPOSITIONED IN THE RIGHT VENTRICULAR OPENING AND CONFIRMED BY ELECTRO-PHYSIOLOGICAL TESTING. TOTAL BEDREST WITH ARM SLING. 10/10/96 RETURNED TO CATH LAB FOR REPLACEMENT OF VENTRICULAR LEAD WITH AN ACTIVE FIXATION SYSTEM.
CARDIOLOGIST WAS PERFORMING RIGHT HEART CATHETERIZATION: INSERTED CATHETER, INFLATED BALLOON TO MANUEVER CATHETER INTO VENA CAVA, NEEDED TO DEFLATE BALLOON, BALLOON WOULD NOT COMPLETELY DEFLATE, FINALLY USED A LARGE SYRINGE TO DEFLATE BALLOON. PROCEDURE WAS SUCCESSFULLY COMPLETED UTILIZING A DIFFERENT CATHETER.
EPIDURAL CATHETER USED FOR EPIDURAL ANESTHETIC WOULD NOT SLIP OUT WHEN PULLED ON. PT RETURNED TO SURGERY FOR REMOVAL.
DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. REPORTEDLY, THE BALLOON DID NOT UNFOLD PROPERLY. WHEN OPENED THE BALLOON INFLATED ONLY ON ONE SIDE AND TORE FASCIA. THE SURGEON CONVERTED TO AN OPEN PROCEDURE. THE HOSP REPORTED THE PT'S STATUS IS SATISFACTORY.
DURING A TRIAL REDUCTION THE TRIAL HEAD CHIPPED, LEAVING DEBRIS IN THE JOINT. THE WOUND WAS IRRIGATED TO CLEAN DEBRIS FROM THE JOINT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: A VISUAL INSPECTION OF THE RETURNED TRIAL HEAD VERIFIED THE COMPLAINT. A DIMENSIONAL INSPECTION OF THE TRIAL HEAD VERIFIED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPEC. THE EVALUATION INDICATES THAT THE POTENTIAL FOR CHIPPING OR FRACTURING OF THE PLASTIC EXISTS WHEN EXCESSIVE FORCE IS USED TO SEAT OR REMOVE THE TRIAL HEAD FROM THE STEM.
ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE PATIENT HAD AN ANTERIOR CHAMBER PUNCTURE ON 12/12/96 WITH INTRAVITREAL VANCOMYCIN. THE LENS WAS REMOVED ON 1/10/97.
EVAL OF THE DEVICE IN CO'S PRODUCT EVAL LAB REVEALED THAT THERE WAS AN INTERLUMEN LEAK IN THE Y ADAPTER. THE BALLOON WAS IN GOOD CONDITION. AS RECEIVED THE CATHETER HAD LIQUID IN THE INFLATION LUMEN. BALLOON DEFLATION WAS SLOWED DUE TO THE PRESENCE OF THE LIQUID. WHEN EVACUATED THE BALLOON DEFLATED NORMALLY. MFG ENGINEER HAS BEEN NOTIFIED OF THIS REPORT.
THE PHYSICIAN WAS ATTEMPTING TO REMOVE A POLYP FROM THE PT'S COLON USING A POLYPECTOMY SNARE. DURING THE PROCEDURE IT WAS NOTED THAT THE SNARE'S DRIVE WIRE DETACHED FORM ITS HANDLE, REND3ERING THE DEVICE INOPERABLE. THE PHYSICIAN REMOVED THE HANDLE AND SHEATH LEAFVING THE DRIVE WIRE AND SNARE IN THE PT. THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE DRIVE WIRE AND SNARE FROM THE PT, HOWEVER, WAS UNSUCCESSFUL DUE TO THE SNARE WAS ENTANGLED AROUND THE POLYP. THE PHYSICIAN UTILIZED FORCEPS TO REMOVE THE ENTANGLED SNARE AND DRIVE WIRE FORM THE PT WITHOUT FURTHER COMPLICATION. THE PT IS REPORTED TO BE IN SATISFACTORY CONDITION.
THIS REPORT IS BASED ENTIRELY ON UNCONFIRMED INFO SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENDED TO BE AN ADMISSION THAT ANY WILSON-COOK DEVICE (I) IS DEFECTIVE OR MALFUNCTIONED(II) CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBURTE TO A DEATH OR SERIOUS INJURY. WE DO NOT BELIEVE THAT THIS REPORTED INCIDENT IS LIKLELY OT REOCCUR. EVALUATON: THE DRIVE WIRE IS DETACHED FORM THE HYPOTUBE. THERE IS NO EVIDENCE OF THE HANDLE CANNULA BEING CRIMPED. CONCLUSIONS: THE HANDLE CANNULA IS NOT CRIMPED TO THE DRIVE CABLE WHICH CAUSED THE DETACHMENT. SUSPECT THE OPERATOR DID NOT FOLLOW SPECIFICATIONS TO CRIP THE DRIVE WIRE TO THE HANDLE CANNULA. CORRECTIVE ACTION: THIS WAS DETERINEDC TO HAVE BEEN AN ISOLATED INDICENT REFLECTING FROM OPERATOR ERROR. PRODUCTION HAS BEEN NOTIFIED AND CORRECTIVE MEASURES HAVE BEEN IMPLEMENTED.
DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE. AFTER PULLING NEGATIVE PRESSURE FOR SEVERAL MINUTES, THE BALLOON DEFLATED. NO PT INJURIES OR COMPLICATIONS OCCURRED.
RETURNED PRODUCT ANALYSIS CONFIRMED THE DEFLATION DIFFICULTIES. EXAM OF TE RETURNED CATHETER REVEALED A KINK IN THE INFLATION LUMEN. THE KINK MAY HAVE RESTRICTED THE FLOW OF FLUID TO AND FROM THE BALLOON. THE CAUSE OF THE SHAFT DAMAGE COULD NOTBE DETERMINED.
HX. BREAST CANCER; MASTECTOMY 5/96. HICKMAN CATHETER PLACED ON LEFT 6/7/96. DEVELOPED PAIN AND SWELLING LEFT ARM. DOPPLER STUDIES REVEALED VENOUS THROMBOSIS. ADMITTED FOR REMOVAL OF CATHETER.
THE LOCATION OF THE DEVICE IS UNK. SO IT WAS RETURNED TO THE MFR FOR EVAL.
DURING A TRIAL REDUCTION THE TRIAL HEAD CHIPPED, LEAVING DEBRIS IN THE JOINT. THE WOUND WAS IRRGATED TO CLEAN DEBRIS FROM THE JOINT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
RESIDENT TILTED OUT OF LIFTER. DURING TRANSFERING FROM CHAIR TO BED.
MFR OF THIS DEVICE BECAME AWARE OF AN EVENT INVOLVING A 20FR FEEDING TUBE ON 10/2/96. THE DEVICE WAS BEING PLACED IN AN OBESE PT. THE DEVICE BECAME STUCK IN THE PT'S ABDOMEN AND WOULD NOT ADVANCE THROUGH THE STOMA. A SURGEON WAS CALLED INTO THE ROOM TO ENLARGE THE INCISION SITE. FURTHER PULLING ON THE TUBE CAUSED IT TO SEPARATE. THE PEG WAS REMOVED AND ANOTHER MFR'S PEG WAS PLACED AND THE PT IS DOING WELL. NO POTENTIAL FOR SERIOUS INJURY APPEARS PROBABLE FROM THE INFO OBTAINED. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE CURCUMSTANCES SURROUNDING THIS EVENT.
THE INSTRUCTION FOR USE FOR THIS DEVICE STATE: "A SMALL INCISION CONTRIBUTE TO EXC4ESSIVE RESISTANCE ON THE GASTROSTOMY TUBE WHEN EXITING THE SKIN. "DO NOT STRETCH OR PULL THE FEEDING TUBE AWAY FROM THE DILATOR TIP. UNDUE FORCE MAY CAUSE THE FEEDING TUBE TO SEPARATE FROM THE DILATOR TIP." THIS INFO SHALL NOT BE CONSTRUED AS AN ADMISSION BY APPLIED MEDICAL. TECHNOLOGY THAT THE PRODUCT(S) DESCRIBED HEREIN ARE OR WERE DANGEROUS IN NAY RESPECT, OR THAT ANUY CASUAL RELATIONSHIP EXISTS BETWEEN THESE PRODUCTS AND ANUY ACTUAL OR PORTENTIAL INJURY. IN ADDITION, THE SUBMISSION OF A REPORT BY APPLIED MEDICAL TECHNOLOGY SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED.
HEALTHCARE PROFESSIONAL REPORTED THAT TWO AORTIC PUNCHES WOULD NOT FUNCTION AND ONE WAS TOO DULL TO CUT THE TISSUE. THERE WAS NO REPORT OF ADVERSE AFFECTS TO THE PT AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.
SUBMISSION OF INFO BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECITON BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." A MEDWATCH FORM ON THIS EVENT WAS NOT RECEIVED FROM THE USER FACILITY. THEREFORE, CO COMPLETED THE FORM WITH INFO FROM THE MD. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFO NOT BEING PROVIDED BY THE REPORTER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN SUCH INFO FROM THE REPORTER, CO IS UNABLE TO COMPLETE FROM 3500A." ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS THEREFORE NO CONCLUSION CAN BE DRAWN. HOWEVER, THE DEVICE HISTORY WAS REVIEWED ON THIS PRODUCT AND FOUND TO MEET ALL SPECIFICATIONS. IF CO WERE TO RECEIVED THE PRODUCT FOR EVAL, A FOLLOW-UP REPORT WILL BE SENT.
PORTION OR IMPACTOR BROKE IN PROSTHESIS DURING HEMI ARTHROPLASTY.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. WHEN STAPLING THE MESH DURING THE CASE THE DEVICE JAMMED AND WAS RENDERED USELESS. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
10/11/96, THE SURGEON WILL NOT BE IN UTIL MONDAY AND IT WOULD BE BEST TO SEND A LETTER. 10/11/96, 1135 NNCL SENT. A1,2,3,4;B6,7;D10;H4; INFO UNAVAILABLE. BASED UPON THE INQUIRE INFO RECEIVED, THE VISUAL EXAM AND THE FUNCITONSLTEST, WAS CONCLUDED THAT THE REPORTED INSTURMENT "JAMMED AND WS RENDERED USELESS" DURING SURGERY MAY HAVE BEEN DUE TO A MISPOSTIONED STAPLE IN THE CARTRIDGE STAPLE TRACK WHICH CAUSED THE INSTRUMENT TO JAM. THE INSTRUMENT WAS RECEIVED WITH A YIELDED CRIMP AND THERE WERE 2 STAPLERS JAMMED IN THE FRONT OF THE STAPLE TRACK. THE FRONT STAPLE HAD BECOME MISPOSITIONED UNDER THE DRIVER CAUSING THE INSTRUMENT TO JAM AND THE SUBSEQUENT YIELDING OF THE CRIMP UPON THE REFIREING OF THE INSTRUMENT. THE INSTURMENT WAS DISASSEMBLED AND THE TUBE WAS OBSERVED TO HAVE BEEN SUFFICIENTLY CRIMPED. THE CARTRIDGE CONTAINED 14 STAPLES. IT WAS CONCLUDED THAT THE MISPOSITIONED STAPLE IN THE CARTRIDGE TRACK AND CAUSED THE TUBE CRIMP TO YIELD. NO CONCLUSION COULD BE REACHED AS TO HOW THE STPALE HAD BECOME MISPOSITIONED IN THE CARTRIDGE TRACK. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. THE INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSUR THE STAPLES FEED, FIRE AND FORM CORRECTLY. THE INSTRUMENT'S STAPLES MAY BECOME TWISTED AND MISPOSITIONED WITHIN THE CARTRIDGE TRACK AND NOSE IF THE INSTRUMENT SUSTAINS A BLUNT TRAUMA. SS S
DEVICE WAS IMPLANTED ON 8/28/96, FOR INFUSION OF CHEMOTHERAPY. ON 10/14/96, A FACILITY NURSE CONTACTED THE MFR'S CLINICAL REP AND STATED SHE TALKED TO SOMEONE AT CO; HOWEVER, DID NOT RECALL THE PERSONS NAME CONCERNING A PT WHO HAD PUMP IMPLANT AND DID NOT COME IN FOR REFILL UNTIL 1 MONTH LATER. REFIL DONE TODAY (10/14/96), STILL SEE LIGHT YELLOW FLUORESCENT SOLUTION IN RETURN VOLUME. THE FACILITY NURSE WANTED TO KNOW WHAT SHE SHOULD DO? THE MFR'S CLINICAL REP ADVISED THE FACILITY NURSE TO RINSE PUMP WITH 50 CC VOLUMES OF NS UNTIL RETURN VOLUME IS CLEAR THEN REFILE PUMP AS USUAL.
ON 10/15/96, A MFR REP CONTACTED THE FACILITY NURSE FOR FURTHER INFO. ADDITIONALLY, FACILITY NURSE STATED THAT DURING THE PT'S FIRST DEVICE REFILL ON 9/16/96 (ALMOST A MONTH AFTER IMPLANT), A YELLOW FLUORESCENT SOLUTION WAS NOTED IN THE RETURN VOLUME. PT HAS RETURNED FOR DEVICE REFILLS ON 9/29/96 AND 10/14/96, AND YELLOW FLUORESCENT SOLUTION WAS STILL NOTED DURING BOTH DEVICE REFILLS. DURING 10/14/96 DEVICE REFILL, THE DEVICE WAS RINSED AS ADVISED BY THE MRF'S CLINICAL REP; HOWEVER THERE WAS STILL EVIDENCE OF YELLOW FLUORESCENT SOLUTION. FACILITY NURSE ALSO INFORMED THE MFR'S REP THAT THE PT IS DOING FINE AND THE DEVICE FLOW RATE IS FINE. NO OTHER PROBLEMS WERE NOTED. PT WAS SCEDULED TO RETURN ON 10/28/96, FOR DEVICE REFILL. THE MFR'S REP INFORMED FACILITY NURSE THAT SHE WOULD CONTACT HER AT THAT TIME FOR AN UNDATE ON PT/DEVICE STATUS. ON 11/11/96, THE MFR'S REP WAS INFORMED BY FACILITY NURSE THAT ON 10/28/96, THE DEVICE WAS REFILLED; HOWEVER, THE NURSE THAT PERFORMED THE DEVICE REFILL MAY NOT HAVE BEEN AWARE THAT THE DEVICE HAD TO BE FLUSHED 5 TIMES AND THERE STILL WAS EVIDENCE OF FAINT YELLOW FLUID IN THE RETURN VOLUME. THE PT WAS DUE IN TODAY (11/11/96) FOR A DEVICE REFILL AND THE FACILITY NURSE REQUESTED THAT THE MFR REP CONTACT HER TOMORROW (11/12/96) FOR AN UPDATE ON PT/DEVICE STATUS. FACILITY NURSE STATED SHE WAS NOT SURE IF SHE WOULD BE THE NURSE PERFORMING THE DEVICE REFIL AT THAT TIME. ON 11/11/96, MFR'S REP CONTACTED A MFR CLINICAL REP AND REQUESTED SHE CONTACTED THE FACILITY NURSE TO INQUIRE IF THEY REUSED THE SAME SOLUTION DURING THE DEVICE FLUSHES OR DID THEY USE FRESH SOLUTION FOR EACH DEVICE FLUSH AND APPROXIMATELY HOW LONG THE SOLUTION REMAINED IN THE DEVICE BETWEEN EACH FLUSH. ON 11/12/96, THE MFR'S CLINICAL REP INFORMED THE MFR'S REP THAT ON 11/11/96, THE FACILITY NURSE STATED THAT FRESH SOLUTION WAS USED FOR EACH OF THE FLUSHES AND THE SOLUTION REMAINED IN THE DEVICE FOR APPROXIMATELY A MINUTE. ADDITIONALLY, THE FACILITY NURSE STATED THAT THE PT WAS IN TODAY 11/11/96, FOR THE DEVICE REFILL. THE DEVICE WAS RINSED ONCE AND NO EVIDENCE OF YELLOW FLUID WAS NOTED.PT IS DOING WELL, DEVICE IS FUNCTIONING AS INTENDED AND WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. A DEVICE SERIAL NUMBER WAS NOT PROVIDED FOR THIS DEVICE; THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED.  THE DEVICE HAS BEEN FLUSHED AND NO FURTHER EVIDENCE OF YELLOW FLUID WAS NOTED. THE FACILITY NURSE STATED THAT THE PROBLEM HAS BEEN RESOLVED. PT IS DOING WELL, DEVICE IS PERFORMING AS INTENDED AND WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. BASED ON THE INFO AVAILABLE, THIS EVENT APPEARS TO HAVE BEEN THE RESULT OF PROCEDURAL/TECHNIQUE RELATED FACTORS AND WAS NOT DUE TO THE DEVICE OR A DEVICE MALFUNCTION. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
THE ROD BROKE THROUGH THE SCREW HOLE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME REPORTED AT THIS TIME.
SUMMARY OF EVALUATION: REQUESTS WERE MADE FOR RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO CO; THEREFORE, EVALUATION OF THIS EVENT CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS COMPONENT IS NOT POSSIBLE AS THE LOT CODE HAS NOT BEEN PROVIDED. THE INFO PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THIS EVENT WOULD BE ASSOCIATED WITH THE DEVICE.
THE PACKAGE DID NOT CONTAIN THE CABLE SLEEVES. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
SUMMARY OF EVALUATION: EVALUATION RESULTS SUGGEST THAT THIS EVENT WOULD BE RELATED TO A PACKAGING ERROR THAT WAS NOT DETECTED DURING INSPECTION.
CULTURE RESULTS WERE REPORTED TO BE STAPHYLOCOCCUS EPIDERMIDS. PATIENT OUTCOME IS REPORTED TO BE FAVORABLE.
IT IS SUSPECTED THAT LOT 96A25 WAS THE SAME LOT USED ON ALL PTS BUT NOT VERIFIED. RETURNED UNOPENED UNITS WERE CHECKED FOR PACKAGE INTEGRITY TO ASSURE THAT STERILITY HAD NOT BEEN COMPROMISED. NO DEFECTS WERE OBSRVED. THE LOT RECORD REVIEW FOUND ALL TESTING WAS SATISFACTORY WHEN THE LOT WAS RELEASED, INCLUDING STERILITY TESTING. THIS PRODUCT IS LABELED FOR SINGLE USE ONLY AND TEH COMPLAINT REPORT INDICATED THAT ONE SYRING IS USED ON TWO PTS. THERE HAVE BEEN NO OTHER ADVERSE REACTIONS REPORTED ON THIS LOT OF VISCOAT TO THE BEST OF THE MFR'S KNOWLEDGE. PRODUCT INFO SUPPLIED IN SEC F WAS PROVIDED BY THE MFR, NOT THE USER FACILITY. THIS REORT WAS MAILED IN TO FDA ON : 11/7/96. THIS INFO IS SUB MITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MDR REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LAB, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. ON THE 6TH FIRING THE ASSISTING SURGEON CLOSED BOTH HANDLES SIMULTANEOUSLY TO REMOVE INSTRUMENT FROM TROCAR. THE NEXT FIRING WAS OK. ON THE 8TH FIRING, THE BLACK FIRING HANDLE BROKE OFF THE INSTRUMETN. OPENED NEW INSTRUMENT TO COMPLETE CSE. FIRED 3X WITHOUT DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7;D5,10.H4: INFO UNAVAILABLE. 10/11/96, 1055 WAS GIVEN 10/11/96 1100 MESSAGE AND 800#800 LEFT FOR MD CALL BACK. 10/14/96 NNCL SENT. BASED ON THE INFO RECEIVED AND THE VISUAL EXAM, IT WAS CONCLUDED THAT HTE INSTURMENT WAS RETURNED NON-FUNCTINAL THE INSTRUMENT WAS DISSASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. THE RETURNED CARTRIDGE HAD THE MIDDLE ALIGNMENT FINGER BROKEN OFF. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT C ARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUMENTS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE DEVICE WAS RELOADED WITH AN EVU35 FOR THE INITIAL FIRING ACROSS THE MESO-APPENDIX. THE DEVICE WAS FIRED AND A SMALL VESSEL WAS BLEEDING MEDIAL TO THE STAPLE LINE. THE STAPLES DID NOT APPEAR COMPLETEDLY FORMED. THE DEVICE WAS RELOADED WITH THE ORIGINAL BLUE RELOAD AND FIRED ACROSS THE APPENDIX WITHOUT DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT. THE REPO IS ALSO SENDING BACK 2 DEVICE RELOADS.
10/11/96 1205 MESSAGE AND 800 # LEFT FOR MD FOLLOW UP. 10/11/96 1330 SURGEON CALLED BACKED STATING HE WAS USING THE DEVICE DURING A DEVICE DURING A LAPAROSOCPIC APPENDECOTMY. THE SURGOEN REPORTED HE REMOVED THE BLUE CARTRIDGE FOR THE DEVICE AND RELOADED WITH A WHITE CARTRIDGE. THE SURGEON SAIND HE FIRED THE DEVICE ACROSS THE BASE OF THE APPENDIX AND WHEN HE OPENED IT HE DISCOVERED A FEW OF THE STAPLES WERE MALFORMED. THE SURGEON RPORTED A VESSEL WAS BLEEDING AT THE STAPLE LINE WHICH HE HAD APPLIED CLIPS IN ORDER TO CONTROL THE BLEEDING. THE SURGEON STATED HE RELOADED THE DEVICE WITH ANOTHER WHITE CARTRIDGE AND FIRED IT WITHOUT DIFFICULTY. THE SURGEON SAID THE DEVICE WAS RELOADED WITH THE SURGEON REPORTED A VESSEL WAS BLEEDING AT THE STAPLE LINE WHICH HE RELOADED THE DEVICE WITH ANOTHER WHITE CARTRIDGE AND FIRED IT WITHOUT DIFFICULTY. THE SURGEON SAID THE DEVICE WAS RELOADED WITH THE BLUE OF CARTRIDGE WHICH HE FIRED ACROSS THE APPENDIX. THE SURGEON REPORTED A FEW OF THE STAPLES DID NOT COMPLETELY FORM,  BUT HE DID NOT TAKE ANY FURTHER MEASURES AND WAS ABLE TO COMPLETE THE PROCEDURE. 10/11/1996 , 1330, THE SURGEON REPORTED THERE WAS NO CONSEQUENCE TO THE PT AND THE PT DID FINE POSTOPERATIVELY. A1,2,3,4; B6,7; D5,10;H4: INFORMATION UNAVAILABLE: SEE CORRESPONDENCE, LOG. BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISION EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED WITH A NICKED KNIFE, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION.T HE INSTRUMENT WAS CYCLED, FIRED, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION, BUT HAD A ROUGH CUT DUE TO THE NICKED KNIFE. NO CONCLUSION COULD BE REACHED AS TO HOW THE KNIFE HAD BECOME DAMAGED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IF FUNCTIONS PROPERLY.
THE CATHETER WAS BEING UTILIZED FOR A DIAGNOSTIC CARDIOLOGY PROCEDURE WHEN IT KINKED IN THREE DIFFERENT PLACES DURING THE PROCEDURE. THE KINKS WERE LOCATED AT THE HUB, 1" FROM THE HUB, AND 2" FROM THE HUB. THERE WAS NO REPORTED INJURY TO THE PT. NOTE: THE EXACT LOT NUMBER OF THE CATHETER USED IN THE PROCEDURE WAS NOT KNOWN FOR CERTAIN. TWO POSSIBLE LOT MARKS WERE REPORTED.
THE DEVICE USED IN THE PROCEDURE WAS NOT RETURNED AND THE EXACT LOT NUMBER OF THE DEVICE COULD NOT BE DETERMINED. THEREFORE, NO EVALUATION COULD BE PERFORMED AND NO CONCLUSION DRAWN. THE ADDITIONAL INFO PROVIDED IN SECTION F WAS SUPPLIED BY MALLINCKRODT.
THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION RESULTS WITH TEST STRIPS. ON 10/13/96 SHE OPENED THE SECOND BOTTLE FROM A BOX OF FIFTY AND OBTAINED CONTROL SOLUTIOJN RESULTS OF 186 AND 181 MG/DL. ON 10/14/96 THE CUSTOMER CALLED THE CO'S CUSTOMER SUPPORT LINE AND, WITH THE REPRESENTATIVE, PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 178 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 108-162 MG/DL. THE CONTROL SOLUTION, NORMAL CONTROL SOLUTION, LOT #VJ095, EXPIRATION 10/97, WAS OPENED ONE WEEK AGO AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. ALSO WITH THE REPRESENTATIVE, THE CUSTOMER PERFORMED A CXHECK STRIP TEST. THE RESULT WAS 94 VERSUS A RANGE OF 88-106. THE CUSTOMER STATED THAT THE FIRST SBOTTLE PERFORMED ACCURATELY. THE DESICCANT IS IN THE OPEN BOTTLE. THE CUSTOMER STORES THE TEST STRIPS IN HER BEDROOM.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 10/30/96. ONE OPENED BOTTLE CONTAINING 5 STRIPS WITH DESICCANT WAS RETURNED TO CO FOR EVALUATION. THE NORMAL CONTROL READINGS OF THE RETURNED STRIPS WERE BELOW THE SPECIFIED CONTROL RANGE. THE LOW NORMAL CONTROL READINGS FROM THE RETURNED STRIPS DO NOT CONFIRM THE COMPLAINT OF OUT OF CONTROL RANGE ON THE HIGH END, AND BASED ON THE EVALUATION OF THE DESICCANT INSIDE THE RETURNED BOTTLE INDICATES THAT THE LOW READINGS OF THE RETURNED STRIPS MAY BE DUE TO EXPOSURE TO MOISTURE. THE MOISTURE EXPOSURE MAY OCCUR AFTER CUSTOMER OPENED THE BOTTLE. THE RETENTION SAMPLE TEST RESULTS FOR LOT 1M508A MEET THE SPECIFICATIONS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE EVALUATION OF RETENTION SAMPLES, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? U. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? U. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSSION THAT MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
HYDROTHERAPY EQUIPMENT PRIMARILY USED FOR WOUND CARE AND DEBRIDEMENT HAS BEEN NOTED TO HAVE DEBRIS IN TANK AFER EMPTYING AND COMPLETE DISINFECTION DONE. THIS PARTICULAR STYLE OF HYDROTHERAPY TANK IS SIMILAR TO COMMERCIAL WHIRLPOOL SYSTEMS WITH JETS. THEREFORE, A CERTAIN AMOUNT OF WATER REMAINS IN THE PUMPING MECHANISM AFTER COMPLETE DRAINING AND DISINFECTION. THERE IS A CONCERN RELATED TO STAGNANT WATER AND BACTERIAL GROWTH, AND ALSO A CONCERN WITH PARTICULATE/DEBRIS MATTER LEFT AFTER THE ENTIRE DISINFECTANT CYCLE IS COMPLETED. THIS MODEL HAS BEEN REPLACED WITH ONE THAT DRAINS COMPLETELY.
STOP COCK TO INTRODUCER PORT FOUND TO BE LEAKING IV FLUID. INSERTED 10/25/96. PT EXHIBITED SIGNS OF HYPOTENSION AND THIS WAS RELIEVED ONCE THE STOPCOCK WAS SWITCHED WITH A NEW ONE.
THE CONNECTOR ON THE INNER CANNULA BROKE WHILE THE HOSPITAL STAFF WAS TURNING THE PT TO BATHE HIM, THE DEVICE HAD BEEN IN USE FOR A MONTH. THE INNER CANNULA WAS RETRIEVED AND REPLACED WITH A TEMPORARY CANNULA UNTIL THE TRACH COULD BE CHANGED OUT. THE PT IS ON A VENTILATOR. NO PT INJURY WAS REPORTED.
ANALYSIS OF THE RETURNED PRODUCT CONFIRMED THE REPORT THAT THE 15 MM CONNECTOR HAD SEPARATED FROM THE INNER CANNULA. A DIMENSIONALY ANALYSIS OF THE TWO MATING PARTS FOUND THE PARTS TO BE WITHIN SPECIFICATIONS. EXCESSIVE FORCE GREATER THAN THAT ASSOCIATED WITH NORMAL USE APPEARS TO HAVE BEEN EXERTED ON THE 15 MM CONNECTOR. A LOT NUMBER REVIEW OF THE MANUFACTURING RECORDS, PRODUCT COMPLAINTS, AND DEVICE HISTORY RECORDS WAS CONDUCTED, AND NO RELATED DISCREPANCIES OR NONCONFORMANCES WERE FOUND ASSOCIATED WITH THE SAME LOT.
DURING A CODE, A TRIPLE LUMEN CATHETER WAS INSERTED INTO THE GROIN. THE CATHETER HAD BEEN INSERTED AND GUIDE WIRES REMOVED. IN THE PROCESS OF SUTURING, THE CATHETER SEPARATED FROM THE HUB OF THE CATHETER LEAVING 10-15" OF CATHETER IN THE GROIN. THE PT EXPIRED OF UNRELATED CAUSES PRIOR TO PLANNED REMOVAL.
THE PT, A TYPE II DIABETIC WHO ADMINISTERS INSULIN, REPORTED BOTH LOWER BLOOD GLUCOSE READINGS AND OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH TEST STRIP, LOT 1H504A. SINCE OPENING THE BOTTLE OF TEST STRIPS, THE PT HAS OBTAINED FOURTEEN OUT OF FOURTEEN BLOOD GLUCOSE READINGS IN THE 60 MG/DL RANGE. SHE IS TYPICALLY IN THE 100 MG/DL RANGE WITH ANOTHER CO'S TEST STRIPS (LOLT UNK). SHE DOES NOT KNOW THE LAST TIME SHE OBTAINED A READING IN THE 100 MG/DL RANGE WITH SECOND TEST STRIPS. WITH THE REPRESENTATIVE, THE PT OBTAINED A NORMAL CONTROL SOLUTION TEST RESULT OF 54 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 104-156 MG/DL (SOLUTION LOT VF125, EXP 6/97). THE PT SHOOK THE CONTROL SOLUTION BEFORE SHE APPLIED THE SAMPLE TO THE TEST PAD. THE CONTROL SOLUTION WAS OPENED ONE WEEK AGO. THE PT WAS UNWILLING TO PERFORM A BLOOD GLUCOSE TEST WITH THE REPRESENTATIVE. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE DESICCANT IS IN ALL BOTTLES. THE SEAL WAS PRESENT IN ALL BOTTLES. ALSO WITH THE REPRESENTATIVE, THE PT OBTAINED BACK TO BACK CHECK STRIP TEST RESULTS OF 89 AND 86 VERSUS A CHECK STRIP RANGE OF 77-103. THE TEST STRIP BOTTLES WERE NOT OPEN FOR A PROLONGED PERIOD OF TIME. THE PT STORES HER TEST STRIPS IN HER BEDROOM.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 10/30/96. ONE OPENED BOTTLE CONTAINING 19 STRIPS WITH DESICCANT WAS RETURNED TO CO FOR EVALUATION. THE TEST RESULT OF THE RETURNED BOTTLE WERE BELOW THE SPECIFICATION FOR BLOOD GLUCOSE ACCURACY. THE NORMAL CONTROL READINGS OF THE RETURNED STRIPS WERE WITHIN THE SPECIFIED RANGE. ERROR GRID ANALYSIS BASED ON CO'S EVALUATION INDICATES THAT THE RETURNED TEST STRIPS PRODUCE RESULTS WHICH FALL IN ZONE D, AND REPRESENT A REASONABLE RISK OF SERIOUS INJURY. EVALUATION OF THE DESICCANT INSIDE THE RETURNED BOTTLE INDICATES THAT FAILURE MAY BE DUE TO EXPOSURE TO MOISTURE. THE SOURCE OF MOISTURE EXPOSURE IS UNK. THE RETENTION SAMPLE TEST RESULTS FOR LOT 1H504A MEET THE SPECIFICATIONS FOR BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READING ARE ALSO WITHIN THE SPECIFIED RANGE. BASED OF THE EVALUATION OF RETENTION SAMPLES, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? U. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? U. IS EVENT OCCURRRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N. SUBMISSION OF THE MDR DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
TRACHEAL BLEEDING WAS REPORTED SHORTLY AFTER THE PT WAS CONVERTED FROM A 3PT TO A 5.0PED TRACHEOSTOMY TUBE DURING ROUTINE REPLACEMENT. BRONCHOSCOPY WAS PERFORMED BUT NO PROBLEMS WERE DETECTED. THE DEVICE WAS INSERTED APPROX. 10/18/96 AND REMOVED 10/30/96. THE DEVICE WAS REPLACED WITH A 3PT WITHOUT FURTHER INCIDENT. THE 5.0PED TRACH TUBE IS NOT AVAILABLE FOR EVALUATION.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "N", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? N. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? N. IF "N", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? N. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
NEEDLE WAS PLACED, PHYSICIAN TOOK ONE CUT AND HAD DIFFICULTY WITHDRAWING NEEDLE. MD REMOVED ENTIRE PROBE AND NEEDLE WAS BENT. NEW SET UP WAS USED. PT HAD MORE DISCOMFORT THAN NECESSARY AND THERE IS THE POTENTIAL FOR BLEEDING.
DURING A ROUTINE PRE-MAINTENANCE CHECK, A BROKEN FOUR POSITION LINE CLAMP WAS FOUND. THERE WAS NO PT INVOLVEMENT.
THIS MDR WAS INADVERTETLY NOT REPORTED WITHIN THE ALLOTTED TIME. DURING A PM PROCEDURE A FOUR POSITION LINE CLAMP WAS FOUND BROKEN, THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL. HOWEVER, ON COMPLAINTS (0896037C3, 0796207C3, 0796157C3, 0795160C3D, AND 0796180C3) IT INDICATES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THE FACILITY CLAIMED THAT THIS OCCURRED WITH NORMAL USE. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR 906627. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
BILATERAL AUGMENTATION DONE IN 1982 TO HELP WITH PTOSIS. SILICONE GEL IMPLANTS WERE USED. PT SUFFERS FROM BACK PAIN, BRA STRAPS GROOVING, SHOULDER PAIN AND INTERTRIGO FOR 5 YRS. IMPLANTS REPLACED 1984. PT HAS OSTEOARTHRITIS IN NECK AND SHOULDERS, GASTRITIS, AND BILATERAL CAPSULAR CONTRACTURES. BILATERAL CAPSULECTOMIES AND REMOVAL OF IMPLANTS WAS DONE ON 10/31/96.
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 2/10/94 AND REMOVED ON 10/14/96 DUE TO "EROSION THROUGH SCROTAL TISSUE," AND BECAUSE IT WAS "PAINFUL." REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFORMATION HAS NOT BEEN RECEIVED. WIHTOUT THE REQUESTED INFORMATION, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION OR PAIN, QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE REPORTS OF INFECTION AND PAIN AS THE REASONS FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THE KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE.
PER THE INFORMATION PROVIDED TO CO BY THE SURGERY CENTER, THE DEVICE WAS REMOVED DUE TO "EROSION THROUGH SCROTAL TISSUE AND PAIN". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED.
NURSE WAS FLUSHING A HEPLOCK AND A 3CC SYRINGE SPRAYED NURSE IN RIGHT EYE. SYRINGE WAS CRACKED. BLOODY FLUID WAS SPRAYED INTO RIGHT EYE. NURSE WENT TO ER AND WAS TREATED AND RELEASED.
DURING PHACOEMULSIFICATION THE SURGEON NOTICED EYE CHAMBER COLLAPSE. THE SURGEON OBSERVED THE ASPIRATION LEVEL BEYOND PRESENT LEVEL.
F6: PRODUCT EVALUATION RESULTS: 1. THE CONSOLE MET ALL SPECIFICATIONS.      2. LINEAR PULSE FOOTSWITCH OUT OF CALIBRATION.  3. I/A MODULE HAD WORN VENT AND VACUUM INSERTS, AND REQUIRED CALIBRATION.  4. CUTTING MODULE MET ALL SPECIFICATIONS. 5. CD PHACO MODULE MET ALL SPECIFICATIONS.
DURING A NEPHROSTOMY PROCEDURE ON A PT THE WIRE GUIDE SEPARATED AT THE SOLDER. THE SEPARATED SEGMENT WAS RETRIVED. ATTEMPTS TO GAIN ADDITIONAL INFO HAVE BEEN UNSUCCESFUL.
A. 1,2,3 4) INFO WAS NOT AVAILABLE H.6) METHOD-DEVICE WAS NOT RETURNED FOR EVALUATION.
A 5CC SYRINGE WAS CRACKED ON THE SIDE. THE NURSE USED THE SYRINGE AND WAS SPRAYED IN THE EYES WITH SOLUTION. EMPLOYEE WAS SEEN IN THE ER AND RELEASED. THE SAME EVENING TWO 3CC SYRINGES AND TWO 5CC SYRINGES WERE FOUND WITH CRACKS IN THEM BY ANOTHER NURSE. THESE SYRINGES DID NOT CAUSE AN EMPLOYEE EXPOSURE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE SILLICON RING OF THE FLAP BULB DROPPED. (COULD RETRIEVE FROM THE PT). THE CASE WAS FINISHED USING A NEW DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
A)BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT'S INNER GASKET BECAME DETACHED DURING SURGERY. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. B)THE INSTRUMENT WAS RECEIVED WITH A CUT OUTER GASKET - ALL PIECES WERE RECEIVED. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS. THE ASSEMBLY LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
PER THE INFO PROVIDED TO CO THROUGH THE MEANS OF A MEDWATCH REPORT, SUBMITTED TO THE OFFICE BY HOSP IS STATED, "REMOVAL OF PENILE PROSTHESIS DUE TO URETHRAL EROSION".
THE INFO PROVIDED IN SECTION F WAS COPIED FROM THE USER FACILITY REPORT RECEIVED FROM THE HOSP, AND MAY NOT BE CONFIRMED BY THIS EVAL OR THIS MFR. QA ATTEMPTED TO OBTAIN ADD'L INFO AND THE RETURN OF THE PROSTHESIS. AT THIS TIME NO ADD'L INFO AND/OR THE DEVICE HAVE BEEN RECEIVED. HOWEVER, EXAM AND TESTING OF THE RETURNED PRODUCT WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF URETHRAL EROSION. THEREFORE, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF THIS AS THE CAUSE FOR SURGICAL INTERVENTION. IN ADDITION, THE LIMITED INFO RECEIVED REFERENCED NO FUNCTIONAL ABNORMALITIES WITH THE DEVICE. BASED ON THIS, QA CONCLUDES DEVICE FUNCTION WAS NOT ASSOCIATED WITH THIS EVENT.
PT EXPERIENCED RASH ON HER HANDS. PT WENT TO DR AND WAS DIAGNOSED AS BEING ALLERGIC TO LATEX AFTER UNDERGOING A SKIN TEST. PT HAS DEVELOPED ASTHMA.
DURING REPLACEMENT OF A STENT IN THE OBTUSE MARGINAL VESSEL, THE DEPLOYMENT BALLOON WOULD NOT DEFLATE. AFTER SEVERAL ATTEMPTS TO DEFLATE THE BALLOON IT RUPTURED. THE VESSEL RUPTURED AND THE PT WAS TAKEN FOR EMERGENCY BYPASS SURGERY.
1 OUT OF 5 IMPLANTS DID NOT INTEGRATE. THE OTHERS SEEM TO BE ALRIGHT. THE DR REPOTS THAT THIS PT IS A SMOKER.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 305% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE PT'S SMOKING IS A PROBABLE CONTRIBUTING FACTOR. THE IMPLANT IS NOT BVELIEVED TO BE THE CAUSE OF FAILURE.
PT EXPERIENCED A RASH ON HER HANDS. SHE WENT TO THE DR AND WAS DIAGNOSED AS BEING ALLERGIC TO LATEX AFTER UNDERGOING A SKIN TEST. PT HAS DEVELOPED ASTHMA.
H/6) METHOD-DEVICE WAS NOT RETURNED FOR EVALUATION.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE TROCAR WAS IN THE UMBILICAL PORT. WELL INTO THE CASE AFTER HAVING TORQUED THE LAPAROSCOPE THE TIP OF THE CANNULA BROKE OFF. IT IS BELIEVED ALL PIECES WERE LOCATED. THE CASE WAS COMPLETED BY ANOTHER 512X TROCAR. THERE WAS NO CONSEQUENCE TO THE PT.
INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
PER THE INFO PROVIDED TO CO BY THE HOSP, THE DEVICE WAS REMOVED DUE TO A "MALFUNCTIONING PUNP". AS REPORTED TO CO,THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
ACCORDING TO AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 3/3/93 AND REVISED ON 9/24/96 DUE TO A "MALFUNCTION, PUMP," ADD'L, "TUBING (WAS) BROKEN AT (THE) PUMP," QA WAS UNSUCCESSFUL IN SECURING EXPLANTED PROSTHESIS FOR EVAL. WITHOUT BENEFIT OF ANALYZING EXPLANT, QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PRECLUDED FROM COMMENTING ON CONDITION OF PROSTHESIS. SHOULD EXPLANTED DEVICE BECOME AVAILABLE, OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN LABELING OR USUAL FOR SERVICE.
DEVICE WAS BEING UTILIZED ON A PT FOR GASTROJEJUNOSTOMY FEEDINGS. SOME TIME AFTER PLACEMENT, THE CATHETER MIGRATED OUT OF THE PT'S STOMACH. THE PT DEVELOPED PERITONITIS. THE PT DEVELOPED PERITONITIS. THE PT WAS TREATED AND RECOVERED FROM THIS EVENT. ATTEMPTS TO OBTAIN ADD'L INFO HAVE NOT BEEN SUCCESSFUL.
H6. OTHER-DEVICE WAS NOT AVAILABLE FOR EVALUATION.
RPTR HAD BILATERAL IMPLANTATION FOR COSMETIC REASONS ON 12/13/83. EXPLANTATION SCHEDULED FOR 12/19/96. RPTR C/O CALCIUM DEPOSITS RT BREAST, ANXIETY, DEPRESSION, S-T MEMORY LOSS, BALANCE DISTURBANCES, CHEST PAIN AND BURNING, THYROID PROBLEMS, DIARRHEA AND/OR CONSTIPATION, HAIR LOSS, JOINT STIFFNESS, RASHES, ITCHING, INSOMNIA, CHRONIC FATIGUE SYNDROME, CAPSULAR CONTRACTURE, AND GEL BLEEDING THROUGH THE ENVELOPE.
3 IMPLANTS PLACED 9/25/96 (1 RIGHT SIDE, 2 LEFT SIDE). PT EXPERIENCED GROSS SWELLING AND SOME PAIN ON LEFT SIDE. BOTH IMPLANTS WERE REMOVED 10/16/96. PT IS A FORMER SMOKER, HAD COLLAPSED LUNG IN THE PAST, ON NO MEDS NOW. ANTIBIOTIC PRESCRIBED ON REMOVAL DATE.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANTS WERE EVALUATED AND FOUND TO MEET SPECIFICATIONS. THE PROBABLE CAUSE OF FAILURE IS THE REPORTED INFECTION, AS EVIDENCE BY THE YELLOWISH RESIDUE ON THE EXTERNAL SURFACE OF THE IMPLANTS.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED AND IT WAS OBSERVED AT THE TIME OF THE EVENT "THERE WAS NO OBVIOUS REASON AS TO WHY THE DEVICE HAD FAILED. BOTH THE CYLINDER(S) AND RESERVOIR WAS PARTIALLY FILLED BUT IT HAD STOPPED FUNCTIONING". THE ONLY POSSIBILITY IS THERE SEEMED LIKE THERE WAS A KINK IN THE TUBING". ADD'L SER NO: 025711.
EVAL AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE/DEVICE COMPONENT. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVAL WILL BE FORWARDED UPON COMPLETION.
DURING AN OPEN SPLENECTOMY WHEN THE CLIP APPLIER WAS FIRED ON APPROX THE 10TH CLIP, THE CLIP DID NOT FORM COMPLETELY. IT APPEARED TO BE IN A TEARDROP SHAPE AT THE APEX OF THE CLIP. THE APPLIER JAMMED AND WOULD NOT FIRE ANY MORE CLIPS. ANOTHER CLIP APPLIER WAS OPENED TO FINISH THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
D6: 9 OTHER INSTRUMENTS RETURNED WITH SAME CATALOG # MCL20, LOT #04668C, BATCH # UNK. A1, 2,3,4; B6, 7; D10: INFO UNAVAILABLE: 10/14/96 THE SURGEON USED THE DEVICE IN THE BEGINING OF THE CASE AND IT WORKED FINE. AFTER SEVERAL FRINGS, THE CLIPS WOULD NOT FORM CORRECTLY AND WOULD NOT CLOSE AT THE PROXIMAL END. ONCE THE MALFORMED CLIPS WERE FIRED, THE DEVICE AND NO OTHER CLIPS WOULD COME OUT. HE REMOVED THE MALFORMED CLIPS AND OPENED ANOTHER TO COMPLETE THE CASE. D5,6; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
PT EXPERIENCED ANTERIOR KNEE PAIN. ARTHROSCOPE REPORTED TO HAVE FOUND POLYETHYLENE TO BE DETERIORATING. REVISION SURGERY PERFORMED 7/10/96.
H3, H6 EVALUATION - NON-DESTRUCTIVE VISUAL EVALUATION WAS PERFORMED ON THE 86-4608 PFC PLI TIBIAL INSERT. THE ULTRA-HIGH MOLECULAR WEIGHT POLYTHYLENE INSERT WAS REVISED DURING SURGERY TO INVESTIGATE THE SOURCE OF KNEE PAIN. THE ARTICULATING SURFACES OF BOTH CONDYLES OF THE TIBIAL INSERT SHOWED AREAS OF BURNISHING, DETAMINATION, PITTING, AND AMBER DISCOLORATION. THE INFERIOR SIDE OF THE INSERT HAD LIGHT BURNISHING OVER MOST OF THE SURFACE. IN SUMMARY, DURING KNEE REVISION SURGERY, A WORN PFC TIBIAL INSERT WAS OBSERVED AND REPLACED. THERE WERE NO APPARENT MATERIAL OR MFG DEFECTS NOTED ON THIS COMPONENT.
X-TUBE ASSEMBLY 20" X 17". DEALER CLAIMS X-TUBE BROKEN AT CENTER PIVOT HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT HAD LAP CHOLE WITH EXTENSIVE ADHESALYSIS. SURGEON SUTURING SUBCUTANEOUS TISSUE WITH 4/0 SUTURE ON NEEDLE WHEN NEEDLE BROKE IN TISSUE. APPROX 2/3 OF NEEDLE WAS LEFT IN TISSUE. MD EXPLORED SITE AND COULD NOT LOCATE NEEDLE. X-RAY WAS TAKEN WHICH DID REVEAL NEEDLE. MD CHOSE NOT TO DO ANYTHING FURTHER TO REMOVE THE NEEDLE. NEEDLE REMAINS IN SUBCUTANEOUS TISSUE AT THIS TIME.
DURING TREATMENT OF A SEMI-CONSCIOUS PT, THE PT PLACED HER HAND ON TOP OF THE 14 MM COLLIMATOR AS THE COLLIMATOR ENTERED THE UNIT. THE TREATMENT WAS IMMEDIATELY ABORTED, BUT THE PT SUFFERED LACERATIONS TO 2 OF HER FINGERTIPS. THE PT REQUIRED SEVERAL STITCHES, SUFFERED NO FRACTURES, AND IS RECOVERING.
THE INCIDENT IS THE 1ST REPORTED WORLD-WIDE AFTER APPROX 200,000 COUCH MOVEMENTS. ALL KNIFE USERS WILL BE INFORMED ABOUT THE INCIDENT, AND PREVENTATIVE MEASURES. ATTACHED IS THE TECHNICAL NOTE DISTRIBUTED TO USERS. DURING THE LAST PHASE OF THE COUCH'S MOVEMENT INTO THE RADIATION UNIT, A PT PLACED ONE HAND ON TOP OF THE COLLIMATOR HELMET. DUE TO THE PROMPT ACTION OF THE TREATING PHYSICIAN, THE COUCH MOVEMENT WAS STOPPED, THEREBY PREVENTING ANY FURTHER DAMAGE, BEYOND LACERATIONS, TO TWO OF THE PT'S FINGERS. CO WOULD LIKE TO EMPHASIZE THE NECESSITY OF INFORMING THE PT OF THE POTENTIAL HAZARD IN MOVING THE HANDS DURING THE TREATMENT. CO RECOMMENDS THAT THE PT BE COVERED WITH A BLANKET, THAT THE COUCH SIDE RAILS BE USED AT ALL TIMES, AND CLOSE OBSERVATION OF THE PT TO AVAOID INCIDENTS DURING THE TREATMENT.
A 58 YEAR OLD MAN WHO HAD UNDERGONE ABDOMINAL SURGERY, DEVELOPED A FALL IN BLOOD PRESSURE DURING A POST-OP RED CELL TRANSDFUSION IN THE ICU. NO PERMANENT ADVERSE EFFECTS WERE REPORTED.
IT WAS DETERMINED THAT NO TESTING WOULD BE DONE ON THE DEVICE BECAUSE IT WOULD NOT YIELD ANY INFO TOWARD EVALUATING THE REPORTED EVENT. ANALYSIS: THE PT WAS RECEIVING PRESSOR AGENTS TO SUPPORT UNSTABLE BLOOD PRESSURE AND WAS RECEIVING TRANSFUSIONS THROUGH A CENTRAL LINE. PT WAS ALSO REPORTED TO BE RECEIVING APPROXIMATELY 22 DIFFERENT MEDICATIONS/THERAPEUTIC AGENT. A LITERATURE SEARCH FOR EXISTING REPORT OF HYPOTENSION FOLLOWING TRANSFUSION VIA A CENTRAL LINE DID NOT REVEAL ANY SUCH PUBLICATIONS. THE EFFECT OF PERFUSING THE MYOCARDIUM WITH A RELATIVELY COLD SOLUTION (I.E. BELOW BODY TEMPERATURE) CONTAINING A CALCIUM CHELATOR IS PRESENTLY UNKNOWN, HOWEVER, IT IS RECOGNIZED THAT PERFUSION OF THE MYOCARDIUM WITH HYPOCALCEMIC FLUIDS DEPRESSES MYOCARDIAL FUNCTION. A MECHANISM FOR SUCH AN HYPOTHESIS IS NOT EVIDENT. THE FACT THAT THE RED CELLS BEING TRANSFUSED WERE BEING FILTERED THROUGH A LEUKOCYTE REDUCTION FILTER AT THE TIME OF THE REPORTE HYPOTENSION MAY BE COINCIDENTAL. MORE THAN 50,000 UNITS OF THIS DEVICE ARE SOLD IN EUROPE PER YEAR AND THESE ARE THE FIRST SUCH REPORTS FILED IN EUROPE (IN WHICH A CLINICIAN HAS IMPLICATED THE DEVICE AS BEING A CONTRIBUTORY AGENT IN THE OBSERVED HYPOTENSION). THE EXACT CAUSE(S) OF THE HYPOTENSIVE EPISODE REPORTED REMAINS INDETERMINATE.
IT WAS REPORTED THAT AFTER DEPLOYMENT OF A STENT INTO A ANTERIOR DESCENDING CORONARY ARTERY, THE GUIDE WIRE PROLAPSED AND 5MM TIP WAS LEFT IN THE DISTAL PORTION OF THE VESSEL. NO PT SEQUELAE WAS REPORTEDLY ASSOCIATED WITH THIS EVENT.
EVALUATION SUMMARY: THE RESULTS OF ANALYSIS CONFIRMED THAT A PORTION OF THE DISTAL WIRE WAS SEPARATED. ANALYSIS OF THIS GUIDE WIRE UNDER SCANNING ELECTRON MICROSCOPY CONCLUDED THAT THE DEVICE FRACTURED AS A RESULT OF TENSILE OVERLOAD. QUALITY ENGINEERING CONCLUDED THAT THE DEVICE HAD BEEN USED BEYOND ITS MATERIAL LIMIT. QUALITY ENGINEERING HAS CONCLUDED THAT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME AS THIS IS A LOW LEVEL FAILURE MODE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR FOR THIS TYPE OF PRODUCT ISSUE. QUALITY ASSURANCE CONSIDERS THIS MDR CLOSED.
THE PT WAS PLACED ON THE VENTILATOR 8-9-96 AND THE EVENT OCCURRED 8-12-96 AT AROUND 10:00 A.M. WHEN THE RT WAS AT THE BEDSIDE SUCTIONING THE PT WITH A CLOSED CATHETER SUCTION SYSTEM, THE THERAPIST NOTICED THAT THE PT AND VENTILATOR WERE BREATHING OUT OF SYNC. THEY SET THE SENSITIVITY AT 2 CMH20 TO 5 CM H20 AND THE VENTILATOR RATE STAYED THE SAME. THE SETTINGS ON THE VENTILATOR AT THE TIME OF THE EVENT WERE AC, SET RATE 13, TRIGGER RATE 18,50% OXYGEN, PEEP +10 CMH20, VT SET AT 850 CC, AND VT EXHALED 944 CC. THE PT'S DIAGNOSIS WAS RESPIRATORY FAILURE AND CARDIOMYOPATHY. THE PT HAD EXPIRED ON ANOTHER VENTILATOR FOUR OR FIVE DAYS AFTER THIS EVENT.
8/29/96: THE AOTOZERO SOLENOID WAS BENCH TESTED AND FOUND TO HAVE A PULLUP TIME OF 11.OMS AND A DROPOUT TIME OF 4.OHMS, SPECIFICATION IS BELOW 70.OHMS. CYCLED SOLENOID 104 CYCLES WITHOUT FAILURE. ATTACHED THE SUSPECT AUTO ZERO SOLENOID TO TO VENTILATOR, SET MODE TO CPAP, RATE 0, PEEP +10 CM H2O, PS 10 CM H2O, AND TRIGGER SET AT -1.5 CM H2O. SET DRIVER VENTILATOR TO PULL NEGATIVE 4 CM H2O. SET POWER ON FOR 15 MINUTES AND OFF FOR 15 MINUTES. STOP CHART RECORDER TO MEASURE PRESSURE SIGNAL OUT OF THE BACK OF THE UNIT. THE UNIT POWERED OFF AN ON FOR MORE THAN 2000 CYCLES WITHOUT DETECTING A FAILURE OF THE AUTO ZERO SOLENOID. THE EVENT AS DESCRIBED BY THE HOSP COULD NOT BE DUPLICATED.
PT HEARD A POP IN HIS SCROTUM. UNABLE TO INFLATE AND DEFLATE DEVICE.
X-TUBE ASSEM 18" X 18". DEALER CLAIMS X-TUBE BROKE AT THE TOP.
DEVICE WAS USED DURING AN APPENDECTOMY PROCEDURE. SUTURE BROKE AND WAS "PARTIALLY ABSORBED". NO PT INJURY REPORTED.
11/12/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
MEDWATCH REPORT RECEIVED BY CO OFFICE FROM THE HOSPITAL, INDICATED IN SECTION F-9, THAT THE APPROXIMATE AGE OF THE DEVICE WAS "4 YRS". THEIR RESPONSE IS BASED FROM THE DATE OF IMPLANT TO EXPLANTATION. CO RECORDS REVEAL THE DEVICE TO BE APPROXIMATELY 5 YRS OLD; BASED ON DATE OF MANUFACTURE TO DATE RELEASES TO FINISHED GOODS. ADDITIONALLY, THE MEDWATCH REPORT RECEIVED FROM THE HOSPITAL: SECTION D-8 REPORTS THAT CATALOG #9000K, SERIAL #198093 WAS REMOVED. THE RECORDS INDICATE THAT PUMP/CYLINDER SER  9918S WAS IMPLANTED AND REMOVED. THE MFR IS IN RECEIPT OF THE EXPLANTED COMPONENT, SERIAL #129965. EVALUATION IS PENDING DECONTAMINATION, EXAMINATION AND TESTING OF THE RETURNED DEVICE COMPONENT(S)> FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OF USUAL FOR SERVICE. AN EVALUATION WILL BE FORWARDED UPON COMPLETION.
A BALLOON RUPTURED AT AN UNK PRESSURE DURING THE FIRST INFLATION OF A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY VIA AN ANTIGRADE APPROACH. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THIS DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. CO'S FOLLOW UP INDICATED THIS BALLOON WAS INFLATED WITHOUT THE USE OF A PRESSURE GAUGE WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "IT IS ESSENTIAL THAT AN INFLATION DEVICE WITH PRESSURE GAUGE (ANOTHER CO'S CATALOG # 15-101 OR ITS EQUIVALENT) BE USED TO MONITOR PRESSURE WITHIN THE BALLOON TO DETERMINE THE ADEQUATE DILATING FORCE IS APPLIED WHILE NOT EXCEEDING THE MAXIMUM LIMITS OF THE PRODUCT. INFLATION IN EXCESS OF RATED BURST PRESSURE MAY CAUSE BALLOON TO RUPTURE. DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON THESE BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY".
DURING CTATRACT PROCEDURE-IT WAS NOTED BY THE SURGEON THAT THE PT SUSTAINED A SCLERAL DISTORTATION AT THE WOUND SITE FOLLOWING PHACOEMULSIFICATION CONSISTENT WITH OVERHEATING. PHACO UNIT REMOVED FROM SERVICE AND MFR NOTIFIED. THE SURGEON NOTED A VERY SMALL AREA ON THE PREVIOUS PT BUT FELT IT NOT SIGNIFICANT ENOUGH TO WARRANT REPORTING UNTIL THE SITUATION REPEATED WITH AN INCREASE IN DISTORTATION.
A 77 YEAR OLD MAN WHO HAD RECENTLY UNDERGONE ABDOMINAL SURGERY, DEVELOPED A FALL IN BLOOD PRESSURE DURING A POST-OP RED CELL TRANSFUSION IN ICU. THE DECREASE IN BLOOD PRESSURE DEVELOPED ONE MINUTE FROM START OF TRANSFUSION. NO PERMANENT ADVERSE EFFECTS WERE REPORTED.
IT WAS DETERMINED THAT NO TESTING WOULD BE DONE ON THE DEVICE BECAUSE IT WOULD NOT YIELD ANY INFO TOWARD EVALUATING THE REPORTED EVENT. ANALYSIS: THE PT WAS RECEIVING PRESSOR AGENTS TO SUPPORT UNSTABLE BLOOD PRESSURE. IT IS UNKNOWN WHETHER THE TRANSFUSION WAS THROUGH A CENTRAL LINE, HOWEVER ANOTHER REPORT RECEIVED FROM THE SAME HOSPITAL (9680602-19960-00004), WHERE A MALE PT WHO ALSO HAD ABDOMINAL SURGERY AND WAS IN ICU EXPERIENCED HYPOTENSION AND WAS RECEIVING THE TRANSFUSION THROUGH A CENTRAL LINE. A LITERATURE SEARCH FOR EXISTING REPORTS OF HYPOTENSION FOLLOWING TRANSFUSION VIA A CENTRAL LINE DID NOT REVEAL ANY SUCH PUBLICATIONS. THE EFFECT OF PERFUSING THE MYOCARDIUM WITH A RELATIVELY COLD SOLUTION (I.E. BELOW BODY TEMPERATURE) CONTAINING A CALCIUM CHELATOR PRESENTLY UNKNOWN, HOWEVER, IT IS RECOGNIZED THAT PERFUSION OF THE MYOCARDIUM WITH HYPOCALCEMIC FLUIDS DEPRESS MYOCARDIAL FUNCTION. A MECHANISM FOR SUCH AN HYPOTHESIS IS NOT EVIDENT. THE FACT THAT THE RED CELLS BEING TRANSFUED WERE BEING FILTERED THROUGH A LEUKOCYTE REDUCTION FILTER AT THE TIME OF THE REPORTED HYPOTENSION MAY BE COINCIDENTAL. MORE THAN 50,000 UNITS OF THIS DEVICE ARE SOLD IN EUROPE PER YEAR AND THESE ARE THE FIRST SUCH REPORTS FILED IN EUROPE (IN WHICH A CLINICIAN HAS IMPLICATED THE DEVICE AS BEING A CONTRIBUTORY AGENT IN THE OBSERVED HYPOTENSION). THE EXACT CAUSE(S) OF THE HYPOTENSION EPISODE REPORTED REMAINS INDETERMINATE.
CUSTOMER COMPLAINT COULD NOT BE DUPLICATED. CAUSE OF EVENT IS NOT KNOWN. THIS MEDWATCH WAS FILED AGAINST THE UNIT: HOWEVER, THE PHACO HANDPIECE USED WITH THIS UNIT WAS RETURNED FOR EVAL. THE COMPLAINT HAS BEEN REGISTERED AGAINST THE DP8020 PHACOEMULSIFICATION HANDPIECE.
PT WAS CARDIOVERTED USING THE PADS. PT WAS NOTED TO HAVE RED MARKS ON THE SKIN WHERE THERE WAS PAD CONTACT. SILVADENE WAS APPLIED.
X-TUBE ASSEMBLY 16" X 16". DEALER CLAIMS X-TUBE BROKEN AT SEAT RAIL.
VISUAL INSPECTIONS UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED APPROX. 9MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX. 79MM AND HAS MIGRATED DOWN LEAD BODY APPROX 16 PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO APPROX 88MM.
LEAD EXPLANTED ON 5/21/97. DEVICE ANALYSIS INDICATES J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
X-TUBE ASSEMBLY 18' X 18'. DEALER CLAIMS X-TUBE BROKE.
THE PT IS EXPERIENCING "PAIN". ADDITIONALLY, THE PHYSICIAN NOTED THAT "THE DEVICE HAS PERFORATED THE URETHRA".
IN THE RECEIVED INFORMATION THE PHYSICIAN STATED THAT THE SURGERY ADDRESSED A "DEVICE REPOSITION." THE PHYSICIAN FURTHER STATED THAT MIGRATION/EROSION HAD OCCURRED AT THE "POSTERIOR CRUS ON LEFT." THE PHYSICIAN ALSO NOTED THAT THERE WAS NO INFECTION PRESENT BECAUSE THE DEVICE REMAINS IMPLANTED AND IS FUNCTIONING AS INTENDED. QA CONCLUDED THAT NO FUNCTIONAL ABNORMALITIES CONTRIBUTED TO THIS EVENT. DUE TO THE NATURE OF THIS EVENT, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF "PAIN" AND "MIGRATION/EROSION" AS THE REASONS FOR SURGICAL INTERVENTION. REPORTS OF THIS NATURE ARE NOT MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.
THE "RAPID GAS LOSS" ALARM SOUNDED FROM THE PUMP. ALL CONNECTIONS WERE CHECKED BUT THE BALLOON WOULD NOT PUMP AND THE IAB WAS REMOVED. ANOTHER WAS NOT INSERTED. THE IAB WAS NOT RETURNED TO CO. FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO. FOR EVALUATION. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. THIS FORM WAS COMPLETED BY THE MANUFACTURER.
X-TUBE ASSEMBLY 16" X 17". DEALER ALLEGES X-TUBE BROKE AT THE CENTER BOLT.
THE PT IS EXPERIENCING "PAIN", AS WELL AS AN "INABILITY TO DEFLATE DEVICE". ADDITIONALLY IT WAS REPORTED THAT THE CAUSE COULD POSSIBLY BE A TUBING KINK. INFECTION WAS ALSO SUSPECTED.
AS REPORTED TO CO'S OFFICE ON 11/4/96, A SURGICAL REVISION DID OCCUR TO ADDRESS THE REPORTED EVENT, (SEE SECTIONS B-2, B-3, B-5, D-8, E-1, G-7, H-1, H-2, H-7, H-10). ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 5/23/96. ON 8/19/96 IT WAS REPORTED TO OUR OFFICE THAT THE PATIENT WAS EXPERIENCING "PAIN AND INABILITY TO DEFLATE" THE PROTHESIS, AND THAT THIS MAY BE CAUSED BY A "POSSIBLE TUBING KINK." AN INFECTION IS ALSO SUSPECTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. ON 11/4/96 SURGERY OCCURRED DURING SURGERY IT WAS NOTED THAT THERE WAS "QUITE A BIT OF SCARRING AROUND THE RELEASE BAR," AND THAT "ONCE IT WAS RELEASED, THE DEVICE WORKED FINE," INDICATING THE REPORTED INABILITY TO DEFLATE WAS MOST LIKELY DUE TO THE WORKED FINE," INDICATING THE REPORTED INABILITY TO DEFLATE WAS MOST LIKELY DUE TO THE OBSERVED SCARRING. NO COMPONENTS WERE REPLACED OR REMOVED. THE PUMP WAS REPOSITIONED. BECAUSE NO COMPONENTS WERE REMOVED/REPLACED, QA CAN NOT PERFORM A MICROSCOPIC EXAMINATION. HOWEVER, BECAUSE QA'S EXAMINATION CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF PAIN OR SCARRING, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT ANY INFECTION ORIGINATED FROM SOURCE OTHER THAN THE DEVICE.
THE IAB WAS INSERTED INTO THE PATIENT TRANSTHORACICALLY. AN ALARM SOUNDED IMMEDIATELY AFTER INITIATION OF THE IABP. THE IAB WAS REMOVED AND A SECOND WAS INSERTED. "MULTIPLE EVENT TO INITIAL COMPLAINT NUMBER 96-00086."
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. FURTHER LABORATORY EXAMINATION REVEALED NO DEFECTS IN THE RETURNED PRODUCT. DEVICE LABEL CODE: 1738.
REPORT RECEIVED SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
X-TUBE ASSEMBLY 18" X 18". DEALER CLAIMS X-TUBE BROKE AT PIVOT POINT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, IN. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION OBY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICIE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKEN ON THE LEFT SIDE BOTTOM.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESINGS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
X-TUBE ASSEMBLY 19" X 17'. DEALER CLAIMS X-TUBE BROKE AT STEM ON TOP.
CASTER HINGE RV. CONSUMER'S MOTHER STATES THAT WHILE HER SON WAS IN SCHOOL, THE BOLT CAME OUT OF THE CASTER HINGE.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, IN. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVIEW FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REPORTER RECEIVED OF SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION.
QR AXLE. DEALER CLAIMS QR AXLE BROKE, SPRING AND OTHER COMPONENTS CAME APART.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CRF PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
A 70 YEAR OLD MALE UNDERWENT OPEN HEART SURGERY. A PLEDGET FELL OFF THE SUTURE WHILE THE SUTURE WAS USED TO SECURE THE PLACEMENT OF THE ARTIFICIAL VALVE. THE PLEDGET WAS NOT RETRIVED; THE OPERATING ROOM STAFF WERE NOT SURE IF THE PLEDGET HAD BEEN IRRIGATED OUT DURING THE RETRIEVAL ATTEMPTS OR WAS STILL LEFT IN THE PT ATTEMPTS. EXAMINATION OF THE SUTURE LINE INDICATED NO BREAKAGE. POSTOPERATIVELY, NO SIGNS OF EMBOLISM WERE NOTED.
DURING CATARACT PROCEDURE -IT WAS NOTED BY THE SURGEON THAT THE PT SUSTAINED A SCLERAL DISTORTION AT THE WOUND SITE FOLLOWING PHACOEMULSIFICATION CONSISTENT WITH OVERHEATING. PHACO UNIT REMOVED FROM SERVICE AND MFR NOTIFIED. (THE SURGEON NOTED A VERY SMALL AREA ON THE PREVIOUS PT BUT FELT IT NOT SIGNIFICANT ENOUGH TO WARRANT REPORTING UNTIL THE SITUATION REPEATED WITH AN INCREASE IN DISTORTATION.
THE HOSP REPORTS THAT THE DELIVERED TIDAL VOLUME WAS APPROX 300ML HIGHER THAT THE PRESET VALUE. THE CLINICAL ENGINEERING DEPT WAS ABLE TO DUPLICATE THE PROBLEM. DURING THE INCIDENT THE VENTILATOR DID NOT ALARM.
THE PC BOARD WAS EVALUATED BY THE MFR. THE PROBLEM WAS ISOLATED TO A SINGLE COMPONENT FAILURE.
CUSTOMER COMPLAINT COULD NOT BE DUPLICATED. CAUSE OF EVENT IS NOT KNOWN. THIS MEDWATCH WAS FILED AGAINST THE UNIT: HOWEVER, THE PHACE HANDPIECE USED WITH THIS UNIT WAS RETURNED FOR EVALUATION. THE COMPALINT HAS BEEN REGISTERED AGAINST THE DP8020 PHACOEMULSIFICATION HANDPIECE.
DEVICE WAS USED DURING UNSPECIFIED PROCEDURE. THE JAWS AND CLIP MALFUNCTIONED. NO PT INJURY REPORTED.
MEDICS WERE MONITORING A PT (AGE AND GENDER UNK) AND THE UNIT'S MONITOR SCREEN INTERMITENTLY WENT BLANK. THERE WAS NO ADVERSE EFFECT ON THE PT. THE COMPLAINANT HAS BEEN UNABLE TO PROVIDE FURTHER INFO.
THE FABRIC WAS IMPLANTED FOR A CAROTID ENDARTERECTOMY PROCEDURE IN A HEPARINIZED PT WITH LOW CARDIAC OUTPUT. AFTERWARDS, THE HEPARIN WAS REVERESED WITH PROTAMINE. WITHIN 24 HRS, THE PT SUFFERED A STROKE DUE TO A THROMBOSIS AT THE OPERATIVE SITE. THE PT WAS THEN THROMBECTOMIZED, BUT NO EVIDENT MECHANICAL CAUSE FOR THE THROMBOSIS WAS FOUND. THE FABRIC WAS LEFT IN. AT THIS TIME, THE PT HAD NOT FULLY RECOVERED FROM THE STROKE. THE PT IS NOW BEING CHECKED FOR HEPARIN ALLERGIES. CO HAS NOW LEARNED THAT THE PT'S CONDITION IS IMPROVING. IN ADDITION, THE PT WAS NOT TESTED FOR HEPARIN ALLERGY.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. IF SUCH INFO BECOMES AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATHCH RECORDS WERE NOT ATYPICAL-NO SIMIAL COMPLAINTS AGAINST THIS BATCH.
DEVICE WAS USED DURING A LAPAROSCOPY PROCEDURE. THE SEAL LEAKED PNEUMOPERITONEUM. NO PT INJURY REPORTED.
THE STENT DELIVERY SYSTEM WAS PLACED IN THE GUIDE CATHETER AND ADVANCED ACROSS THE TARGET LESION. WHEN NEGATIVE PRESSURE WAS APPLIED TO PURGE THE UNIT, BLOOD WAS NOTED AT THE BALLOON PORT. THE STENT DELIVERY SYSTEM WAS RETRIEVED AND A 2ND DELIVERY SYSTEM WAS USED TO SUCCESSFULLY DEPLOY A STENT. NO PT COMPLICATIONS WERE REPORTED.
THE ROOT CAUSE ANALYSIS INDICATED THE LEAK RESULTED FROM A LACK OF ADHESIVE AT THE GUIDEWIRE HUB TO INNER LUMEN BOND AND INSUFFICIENT ADHESIVE AT THE Y CONNECTOR TO INNER LUMEN BOND. THIS TYPE OF LEAKAGE WAS PREVIOUSLY INVESTIGATED AND APPROPRIATE CORRECTIVE ACTION PLANS HAVE BEEN DEVELOPED TO PREVENT RECURRENCE. THE FOLLOWING IMPROVEMENTS WERE MADE TO THE MFG PROCESS: AN AUTOMATED LEAK TEST FOR 100% IN-PROCESS INSPECTION WAS PROVIDED; 100% IN-PROCESS TUBING OD INSPECTIONS WERE IMPLEMENTED; PROCESS WERE MODIFIED TO REDUCE HANDLING AND VARIATION IN TUBING SIZE; AND THE IMPROVED BONDING PROCESSES WERE QUALIFIED. THESE BONDING IMPROVEMENTS INCLUDED CLARIFICATION OF THE AMOUNT AND LOCATION OF ADHESIVE APPLICATION.
MEDICS WERE MONITORING A PT AGE (AGE AND GENDER UNK) AND THE UNIT'S MONITOR SCREEN INTERMITENTLY WENT BLANK. THERE WAS NO ADVERSE ON THE PT. THE COMPLAINANT HAS BEEN UNABLE TO PROVIDE FURTHER INFO.
THE FABRIC WAS IMPLANTED FOR A CAROTID ENDARTERECTOMUY PROCEDURE IN A HEPARINIZED PT WITH LOW CARDIAC OUTPUT. AFTERWARDS, THE HEPARIN WAS RECVERSED WITH PROTAMINE. WITHIN 24 HOURS, THE PT SUFFERED A STROKE DUE TO A THROMBOSIS AT THE OPERATIVE SITE. THE PT WAS THEN THROMBECTOMIZED, BUT NO EVIDENT MECHANICAL CAUSE FOR THE THROMBOSIS WAS FOUND. THE FABRIC WAS LEFT IN. AT THIS TIME, THE PT HAD NOT FULLY RECOVERED FROM THE STROKE. THE PT IS NOW BEING CHECKED FOR HEPARIN ALLERGIES. NOTE: CO HAS NOW LEARNED THAT THE PT'S CONDITION IS IMPROVING. IN ADDITION, THE PT HAS TESTED NEGATIVE FOR HEPARIN ALLERGY.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVALUATION, THE COMPLAINT CANOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECITON "F" COMPLETED BY MFR. CODE 86:  THE QUALITY ASSURANCE TEST RECORDS FOR THIS PRODUCT WERE REVIEWED. CODE 100: THE TEST RECORDS WERE NOT ATYPICAL - NO SIMILAR COMPLAINTS AGAINST THIS BATCH.
DEVICE WAS USED DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE. STAPLES DID NOT LOCK. SURGEON APPLIED SUTURE TO COMPLETE THE PROCEDURE. THE HOSP REPORTED THAT NO PT INJURY OCCURRED.
THE REPORT INDICATED THAT APPROXIMATELY 2-3 MINUTES INTO CARDIOPULMONARY BYPASS, "BLACK" BLOOD WAS NOTED EXITING THE ARTERIAL PORT. THE DEVICE WAS CHANGED OUT WITH NO PT INJURY. THE CLINICIAN REVIEWED THE CONNECTIONS TO THE HEART LUNG MACHINE AND BLENDER WITH NO ANOMALIES NOTED.
THE OXYGENATOR WAS RECEIVED FOR COMPLAINT EVALUATION ON 10-24-96. THE RETURNED DEVICE WAS SET-UP IN A SIMULATED PERFUSION CIRCUIT FOR PERFORMANCE TESTING UNDER THE OBSERVATION OF A TECHNICIAN. PRIOR TO TESTING, THE UNIT WAS RINSED WITH PEROXIDE/WATER SOLUTION. VISUAL EXAMINATION NOTED NO PHYSICAL ANOMALIES ON THE RETURNED OXYGENATOR. TESTING WAS PERFORMED AND THE CO2 TRANSFER, O2 TRANSFER, AND BLOOD PRESSURE DROP WERE RECORDED. ONLY THE BLOOD PRESSURE DROP WAS SLIGHTLY OUTSIDE THE SPECIFICATIONS. THE RESULTS OF THE TESTING ARE AS FOLLOWS: SERIAL NUMBER 1599659; MINIMUM SPEC. O2 TRANSFER, 389 ML/MIN, 360 ML/MIN, CO2 TRANSFER, 318 ML/MIN, 285 ML/MIN, PRESSURE DROP, 77 MMHG, 80-150 MMHG. DISLCLAIMER STATEMENT: THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIVISION, ITS OFFICERS, EMPLOYEES, OR AGENTS.
RIGHT IMPLANT HAS RUPTURED AND PT IS EXPERIENCING DISCOMFORT. SHE HAS GONE TO THE DR. EXPLANT SURGERY IS BEING SCHEDULED.
FIREFIGHTERS WIRE TREATING A 50 YR OLD MALE PT WHO WAS EXPERIENCING A CARDIAC ARREST AND HAD A LONG HISTORY OF CARDIAC PROBLEMS. THE UNIT ADVISED THE FIREFIGHTERS TO DEFIBRILLATE AND THEY DEFIBRILLATED THE PT. THEY WERE USING A UNIT THAT HAD A BLANK ECG DISPLAY SO THEY WERE UNABLE TO READ THE PT'S ECG TRACE. THE PT SUBSEQUENTLY EXPIRED. THE COMPLAINANT INDICATED THAT THE PT WAS NOT A "VIABLE" PT. THE FIREFIGHTERS LATER EXAMINED THE STRIPS FROM THE CODE AND INDICATED THAT THE PT WAS DEFIBRILLATED WHILE HIS RHYTHM WAS IN PEA AND THAT THE UNIT SHOULD NOT HAVE ADVISED A DEFIBRILLATION ATTEMPT. THE FACILITY'S TERRITORY MANAGER MET WITH THE FIREFIGHTERS AND REVIEWED THE OPERATION OF THE UNIT. AFTER THE IN-SERVICE, THE COMPLAINANT INDICATED THAT THE UNIT FUNCTIONED PROPERLY DURING THE CODE.
USER DID NOT UNDERSTAND OPERATION OF THE DEVICE. AFTER INSERVICING, THE USER INDICATED THAT THE DEVICE HAD FUNCTIONED PROPERLY DURING THE CODE.
DISTRIBUTOR RECEIVED A BAG OF SALIVA EJECTORS FROM A DR'S OFFICE WHICH THE TIPS WERE COMING OFF OF THEIR STEMS. A TIP CAME OFF IN A PT'S MOUTH HOWEVER, IT WAS PROMPTLY REMOVED AND NO HARM WAS CAUSED TO THE PT.
SEC. 6-RESULTS CODE 100-ADHESION FAILURE. VISUAL INSPECTION: TIPS ARE LOOSE IN THE BAG. BAG IS NOT IN GOOD CONDITION AND IT IS TAPED CLOSED ON THE BOTTOM. PHYSICAL INSPECTION: A PULL TEST WAS CONDUCTED ON THE EJECTORS. THREE SEPARATE SAMPLE GROUPS OF 10 WERE TAKEN. THE RESULTS ARE AS FOLLOWS: 1ST LOT-10 EJECTORS-ALL TIPS WERE EASILY REMOVED FROM THEIR STEMS. 2ND LOT-9 OF 10 TIPS WERE EASILY REMOVED FROM THEIR STEMS. 3RD LOT-8 OF 10 TIPS WERE EASILY REMOVED FROM THEIR STEMS.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT FORM PROPERLY. SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE ACCOUNT OBTAINED DISCREPANT RESULTS WHEN A RANDOM URINE SPECIMEN GAVE A NEGATIVE RESULT USING THE HCG KIT AND THE URINE SPECIMEN GAVE A RESULT = 114 MLU/ML WHEN RUN ON THE INSTRUMENT. THE PT'S BLOOD WAS DRAWN AND A SERUM RESULT = 312 MLU/ML ON THE INSTRUMENT. THE ACCOUNT REPEAT TESTED THE URINE SPECIMEN ON THE DEVICE FOR A POSITIVE RESULT. THE PT HAD COME TO THE ER FOR A SPRAINED WRIST AND COMPLAINTED OF RADIATING RIGHT FLANK PAIN WITH NAUSEA AND VOMITING. THE PT WAS UNSURE OF LMP. SHE WAS TREATED IN THE ER FOR A SPRAINED WRIST AND REFERRED TO HER DR FOR PREGNANCY FOLLOW-UP.
DURING A DIALYSIS TREATMENT A FOUR POSITION LINE CLAMP BROKE. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THERE WERE NO RELATED CPF/DTF DEFECTS REPORTED FOR THIS MACHINE. THE RETURNED FOUR-POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT THE CLAMP HOLDER WAS BROKEN. THE TABS ON THE WHITE CLAMP INSERT HOLDER WAS BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
PROBABLE LEAKING LEFT BREAST IMPLANT. RE-AUGMENTATION DONE ON 10/14/96.
DURING ECMO SUPPORT OF A 57 KILO PATIENT GAS TRANSFER PERFORMANCE WAS IMMEDIATELY COMPROMISED. THE OXYGENATOR WAS CHANGED OUT AND NO PT INJURY WAS OBSERVED. ECMO IS AN OFF LABELED USE OF THE DEVICE.
NOTE: TESTING ON RETURNED DEVICE NOTED PLASMA BREAKTHROUGH. REFERENCE SECTION H.3 DISCLAIMER STATEMENT: THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIVISION, ITS OFFICERS, EMPLOYESS, OR AGENTS. THE DEVICE WAS RECEIVED ON 10/29/96 FOR EVALUATION. THE RETURNED DEVICE WAS SET-UP IN A SIMULATED PERFUSION CIRCUIT FOR TESTING. AFTER APPROXIMATELY 15 MINUTES ON THE CIRCUIT, PLASMA BREAKTHROUGH WAS NOTED BY THE TECHNICIAN. THE EFFLUENT WAS COLLECTED AND A SPECIFIC GRAVITY ANALYSIS WAS CONDUCTED. THE RESULTS INDICATED THAT THE SPECIFIC GRAVITY WAS WITHIN THE KNOWN LIMITS OF PLASMA.
DEVICE WAS USED DURING A CHOLECYSTECTOMIA PROCEDURE. THE CLIPS DID NOT LOAD PROPERLY. SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE LINER STOPPED SUCKING BEFORE IT BECAME FULL, DUE TO DYSFUNCTIONAL SHUT-OFF VALVE.
AN EAM OF THE LOT HISTORY RECORD SHOWED THAT WHEN THE LIDS WERE PRODUCED FOR THE UNITS THERE WAS NO PROBLEM THAT WOULD CAUSE PREMATURE SHUT-OFF. THE PRODUCT THAT WAS RETURNED WAS TESTED IN CO'S LAB FOR THE FUNCTIONAL FILLING AND SHUT-OFF WHEN THE UNIT WAS FULL. THE PLANT WAS NOT ADVISED OF ANY SPECIAL CIRCUMSTANCES SURROUNDING THE OCCURRENCE, SO THEY USED THEIR STANDARD PROTOCOL FOR UNIT FILLING TO SHUT-OFF. BOTH UNITS WERE FOUND TO MEET THE PERFORMANCE CRITERIA. AT THIS TIME THERE IS NO CONCLUSION FOR THE FAILURE OF THE UNITS. TESTING WAS DONE USING THE STANDARD METHOD AND THERE WAS NO ADD'L INFO GENERATED DURING TESTING. THE UNIT IS DESIGNED TO PREVENT ACCIDENTAL SPILLS, SPLASHING, VACUUM SOURCE CONTAMINATION AND BACK FLOW THROUGH THE ACTIVATION OF THE SHUT-OFF MECHANISM. WHEN THE UNIT IS SUBJECTED TO A PUMP, INTERNAL SPLASH OR FOAM BUILD-UP THE FLOAT MECHANISM WILL INITIATE THE SHUT-OFF PROCESS. THE VACCUUM CAN BE RESTARTED BY DISCONNECTING THE VACUUM SUPPLY AT THE VACUUM PORT ON THE LID AND WILL ALLOW THE VALVE TO MOVE BACK INTO THE OPEN POSITION.
DURING A HYSTEROSCOPY PROCEDURE, CO2 REBREATHING WAS NOTED ON MONITOR AND ANOTHER MONITOR WAS TRIED. NO DIFFERENCE WAS NOTED. BREATHING CIRCUIT WAS CHANGED AND PROBLEM DISAPPEARED. AFTER SURGERY IT WAS DISCOVERED THAT A SMALL HOLE EXISTS IN THE SAMPLING LINE AT THE POINT THAT IT EXITS FROM THE INSIDE OF THE BREATHING LINE TUBING. THIS ALLOWS ERRONEOUS CO2 READINGS TO OCCUR ON THE MONITOR. THIS PROBLEM DELAYED SURGERY FOR ALMOST 1/2 HR AND RESULTED IN PT RECEIVING ANESTHESIA FOR 1/2 HR LONGER THAN NECESSARY. THIS BREATHING CIRCUIT AND OTHERS FRESH FROM THE PACKAGING WERE EXAMINED FOR LEAKS IN THE SAMPLING TUBING AT THIS POINT WITH THE USE OF WATER IN A SYRINGE INTRODUCED INTO THE SAMPLING LINE. SEVERAL MORE INSTANCES OF LEAKING WERE FOUND. SALES REP FOR DISTRIBUTOR, OF ANESTHESIA SVS OBSERVED ONE OF THESE TESTS WHICH INDICATED A LEAKING TUBE. HE SENT DEFECTIVE SAMPLE TO MFR.
REPORTER NOTED SMALL CORNEAL BURNS ON FIRST THREE CASES. NEW HANDPIECE HAD BEEN USED. CHANGED TO DEMO UNIT FOR LAST CASES WITHOUT PROBLEM. FEELS THAT SYSTEM IS A PROBLEM. NO PERMANENT INJURIES REPORTED.
H-10: A CO SVC REP CHECKED THE SYSTEM AND FOUND IT TO MET ITS PERFORMANCE SPECS. NO ADD'L PT INFO WILL BE AVAILABLE. H-11: SECTION F INFO WAS SUPPLIED BY USER FACILITY. F-10: 1757-LABELED. THIS REPORT WAS MAILED IN TO FDA ON : 11/08/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
45 MINUTES INTO CARDIOPULMONARY BYPASS, LOW PCO2 WAS NOTED. THE DEVICE WAS CHANGED OUT WITH NO PT INJURY.
THE UNIT WAS RECEIVED FOR COMPLAINT EVALUATION ON 11/5/96. THE RETURNED DEVICE WAS SET-UP IN A SIMULATED PERFUSION CIRCUIT FOR PERFORMANCE TESTING UNDER THE OBSERVATION OF A TECHNICIAN. PRIOR TO TESTING, THE UNIT WAS RINSED WITH PEROXIDE/WATER SOLUTION. VISUAL EXAMINATION NOTED NO PHYSICAL ANOMALIES ON THE RETURNED OXYGENATOR. TESTING WAS PERFORMED AND THE CO2 TRANSFER, O2 TRANSFER, AND BLOOD PRESSURE DROP WERE FOUND TO BE WITHIN THE SPECIFICATIONS, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE RESULTS OF THE TESTING ARE AS FOLLOWS: SERIAL NUMBER 1526361 MINIMUM SPEC. O2 TRANSFER, 392 ML/MIN, 360 ML/MIN, CO2 TRANSFER, 324 ML/MIN, 285 ML/MIN, PRESSURE DROP, 89 MMHG, 89-150 MMHG. DISCLAIMER STATEMENT: THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIVISION, ITS OFFICERS, EMPLOYEES, OR AGENTS.
DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. SURGEON APLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME. DURING A PM PROCEDURE A FOUR POSITION LINE CLAMP WAS FOUND TO BE BROKEN. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL. HOWEVER, ON COMPLAINTS (0896037C3, 0796207C3, 0796160C3, AND 0796180C3) IT INDICATES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THE FACILITY CLAIMED THAT THIS OCCURRED WITH NORMAL USE. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY A DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027. CUSTOMER CONTACTE: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRANING REQUIRED? NO.
AN ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE UNIDENTIFIED TARGET LESION SITE. UPON THE INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON BURST (ATMOSPHERE OF PRESSURE UNKNOWN) LEAVING THE STENT PARTIALLY EXPANDED AT THE TARGET LESION SITE. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION. AN ADD'L BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
SINCE 11/1/96, 3 CATHETERS FOUND NOT TO DRAIN WITH THREE DIFFERENT PEOPLE.
6. 68 ONE DEVICE FUNCTIONED PROPERLY. ONE DEVICE SHOWED SLIGHT INTERNAL BLISTER.
FACILITY HAS EXPERIENCED THREE PROBLEMS OF A REPETITIVE NATURE FOUND AMONG 44 BEDS PURCHASED FROM THIS MFR. ALTHOUGH MFR HAS BEEN CONTACTED CONCERNING THESE PROBLEMS, MEASURES TO CORRECT THEM HAVE BEEN INADEQUATE. HI/LO MOTOR SCREW ASSEMBLY HAS CURRENTLY FAILED IN 4 INSTANCES. THE SCREW ITSELF HAS BENT AT AN ANGLE TOO SEVERE FOR HI/LO MOTOR TO OPERATE, RESULTING IN THE TRANSPORT OF PT TO ANOTHER BED. TRENDELENBURG/REVERSE TRENDELENBURG BRACKET HAS IN TEN CASES PROVEN TO BE INSUFFICIENT IN STRENGTH TO SUSTAIN THE WEIGHT OF PT AND/OR MEDICAL PROFESSIONAL IN THE CASE OF TREATMENT, SUCH AS THE APPLICATION OF PRESSURE TO PT'S CHEST. SHOULDER BOLTS WHICH SUPPORT THE FOUR CORNERS OF THE BED HAVE BEEN FOUND LOOSE IN NUMEROUS OCCASIONS AND HAVE FALLEN OUT OF ONE CORNER OF THE BED ON TWO OCCASIONS CAUSING EXTREME UNEVENNESS. THESE PROBLEMS THOUGH NOT ALL INCLUSIVE, PRESENT OBVIOUS PT DISSATISFACTION, AND IF LEFT UNATTENDED PRESENT THE POSSIBILITY FOR A PT INJURY FROM SUDDEN CHANGES IN HEAD OR FOOT POSITION.
A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY. UPON THE INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON RUPTURED AT 2 ATM OF PRESSURE, LEAVING THE STENT PARTIALLY DEPLOYED AT THE TARGET LESION SITE. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION. AN ADD'L BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
DURING A ROUTINE PRE-MAINTENANCE CHECK, A BROKEN FOUR POSITION LINE CLAMP WAS FOUND. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD. DURING A PM PROCEDURE A FOUR POSITION LINE CLAMP WAS FOUND TO BE BROKEN. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THE FOUR-POSIOTION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL. HOWEVER, ON COMPLAINTS (0896207C3, 07962037C3, 0796157C3, 0796160C3, AND 0796180C3) IT INDICATES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THE FACILITY CLAIMED THAT THIS OCCURRED WITH NORMAL USE. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY, THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN  ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR 960027. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.
THE PHYSICIAN REPORTED ENCOUNTERING SIGNIFICANT PROBLEMS WITH THE MOVEMENT OF THE ANGIOPLASTY PRODUCTS THROUGH THE GUIDE. DURING THE PROCEDURE THREE BALLOONS, A BURR AND EVENTUALLY A STENT WERE USED. SUBSTANTIALLY MORE CONTRAST DYE WAS NEEDED BECAUSE OF THE LENGTH OF THE CASE AND THE PT REC'D SUBSTANTIALLY MORE FLUOROSCOPY TIME AND CINEANGIOGRAPHIC TIME. THE PHYSICIAN REPORTED THAT THIS WAS A SERIOUS RISK TO BOTH THE SUCCESS OF THE PROCEDURE AND THE HEALTH OF THE PT. THE CASE WAS COMPLETED UNEVENTFULLY.
THE DEVICE WAS NOT RETURNED FOR EVAL SINCE IT WAS DISCARDED BY THE HOSP CARDIAC CATH LAB. THE LOT NUMBER OF THE DEVICE WAS NOT KNOWN. HOWEVER, THE LOT NUMBER WAS DETERMINED TO BE ONE OF THE FOLLOWING: 43080, 45824, 42934. A REVIEW OF THESE LOT HISTORY RECORDS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
THE PILOT BALLOON OF THE TRACHEOSTOMY TUBE DETACHED FROM THE INFLATION LINE. AFTER APPROX 2 WEEKS USE. THE TRACHEOSTOMY TUBE WAS REMOVED AND REPLACED AND THERE WAS NO PT INJURY.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO CO, PURSUANT TO 21 C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AN ADMISSION BY THE CO THAT A DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A CO DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. H.6 RESULTS. CODE 100: ONLY PART OF THE DEVICE WAS RETURNED MAKING CO'S EVAL INCONCLUSIVE. ONLY THE PILOT BALLOON PORTION OF THE TRACHEOSTOMY TUBE WAS RETURNED FOR EVAL; THE REST OF THE INFLATION LINE AND THE TUBE AND CUFF WERE DISCARDED. CO'S VISUAL EXAM OF THE RETURNED PILOT BALLOON REVEALED THAT IT HAD BEEN HARDENED. IT IS DIFFICULT TO DETERMINE THE CAUSE OF THIS PHENOMENON, ESPECIALLY SINCE ONLY A PORTION OF THE DEVICE WAS RETURNED FOR EVAL. THE SQUARE END OF THE BREAK MAY INDICATE THAT THE BALLOON WAS BROKEN OR PULLED OFF OF THE INFLATION LINE. CO'S EXAM REVEALED NO EVIDENCE OF CHEMICAL DEGRADATION FROM CO'S MFG PROCESS. REVIEW OF THE DEVICE HOSTORY RECORD FOR THIS DEVICE REVEALS THAT NO PROBLEMS WERE NOTED DURING MFG. REVIEW OF CO'S COMPLAINT DATABASE REVEALED NO SIMILAR REPORTS FOR THIS MFG LOT OF TRACHEOSTOMY TUBES. CO IS UNABLE TO DETERMINE THE CAUSE OF THIS EVENT, HOWEVER, IT DOES NOT APPEAR TO BE MFG PROCESS RELATED.
ONE ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S ILIAC ARTERY. UPON THE INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON BURST LEAVING THE STENT PARTIALLY EXPANDED. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT. AN ADD'L BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT AT THE TARGET LESION SITE. THERE WERE NO CLINICLA SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE P908 BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY.
PRODUCT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. HOSP HAS REPROTED THAT NO PT INJURY OCCURRED.
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
THE PT WAS RECEIVED BY THE HOSPITAL IN CARDIOGENIC SHOCK. PERCUTANIOUS CARDIOPULMONARY BYPASS WAS INITIATED AS PT HAD NO CARDIAC OUTPUT ANE WAS IN VENTRICULAR FIBRILLATION. APPROX. 16 1/2 HRS LATER, LEAKAGE WAS NOTED FROM THE PUMP. THE DEVICE WAS CHANGED OUT. THE PT PASSED AWAY; HOWEVER, THE PHYSICIAN STATED THAT THE DEVICE CHANGE-OUT DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. CO'S LABELING FOR THE DEVICE INDICATES THAT THE PUMP SHOULD BE CHANGED AT LEAST EVERY 6 HRS.
THE PUMP WAS RECEIVED FOR COMPLAINT EVALUATION BY CO ON 10/25/96. VISUAL EXAMINATION NOTED SEVERAL CRACKS IN THE HOUSING JOINT OF THE DEVICE. THIS TYPE OF "CLEAN" CRACK IS CONSISTENT WITH DEVICE WHICH HAS BEEN SUBJECTED TO RE-STERILIZATION BY THE HOSPITAL, OR CONTACT WITH AN ALCOHOL BASED SUBSTANCE. THIS TYPE OF CRACK IS NOT CONSISTENT WITH THE DEVICE RECEIVING AN IMPACT OR PRESSURE, THE INSTRUCTION FOR USE WHICH ACCOMPANY EACH PUMP STATE UNDER THE WARNINGS/PRECAUTIONS SECTION: DO NOT USE ALCOHOL OR ALCOHOL BASED FLUIDS ON ANY SURFACE OF THE PUMP. EACH PUMP IS INTENDED FOR SINGLE USE. DO NOT RESTERILIZE. DISCARD AFTER USE. THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PART 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIOPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIVISION, ITS OFFICERS, EMPLOYEES, OR AGENTS.
COMPLAINANT HAD THE INTERNAL DEFIBRILLATOR INSTALLED ON 8/21/95. AFTER A YEAR AND TWO WEEKS THE DEVICE MALFUNCTIONED, THE BATTERY WENT DEAD. THE DEVICE HAD TO BE SURGICALLY REMOVED IN 9/96.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. VISIBILITY WAS POOR. SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED ON A MYOCARDIAL INFARCTION CASE. DURING THE PROCEDURE, A 2.5MM BALLOON HAD BEEN PASSED THROUGH THE DEVICE, WITHDRAWN, AND A 3.0MM BALLOON HAD BEEN PLACED ACROSS THE DEVICE. UPON ATTEMPT TO RE-ADVANCE THE 3.0MM BALLOON THERE WAS SERIOUS BINDING IN THE DEVICE. THE PHYSICIAN REPORTED THAT THIS WAS A SERIOUS AND POTENTIALLY LIFE THREATENING PT ISSUE. THE CASE WAS COMPLETED UNEVENTFULLY WITH ANOTHER DEVICE.
THE DEVICE WAS NOT RETURNED FOR EVAL SINCE IT WAS DISCARDED BY THE HOSP CARDIAC CATH LAB. THE LOT NUMBER OF THE DEVICE WAS NOT KNOWN. HOWEVER, THE LOT NUMBER WAS DETERMINED TO BE ONE OF THE FOLLOWING: 43080, 45824, 45818 OR 42934. A REVIEW OF THESE LOT HISTORY RECORDS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
ONE ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S ILIAC ARTERY. UPON THE INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON BURST LEAVING THE STENT PARTIALLY EXPANDED. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT. AN ADD'L BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD. DURING A PM PROCEDURE A FOUR POSTION LINE CLAMP WAS FOUND BROKEN. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THERE WAS NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL. HOWEVER, ON COMPLAINTS (0896037C3, 0796207C3, 0796157C3, 1796160C3, AND 0796180C3) IT INDICATES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER., IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THE FACILITY CLAIMED THAT THIS OCCURRED WITH NORMAL USE. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES. AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR 960027. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRANING REQUIRED? NO.
THE CUSTOMER IS A 78-YR-OLD MALE II DIABETIC ON INSULIN. HIS DAUGHTER, WHO PERFORMS HIS TESTING, REPORTED INACCURATELY LOW BLOOD GLUCOSE READING WITH TEST STRIPS, L/N UNK. SHE OPENED THE BOTTLE APPROX 4 WKS AGO AND OBTAINED NORMAL BLOOD GLUCOSE READINGS. APPROX A WK LATER, HER FATHER'S READINGS BEGAN TO DECREASE TO THE 20-50 MG/DL. SHE TOOK HIM TO THE DR AND REPORTED THE LOW READINGS. THE DR TOOK A VENOUS SAMPLE WHICH WAS SENT TO THE LAB, AND ADVISED HIS PT TO STOP TAKING HIS INSULIN FOR THE MEANTIME. THE CUSTOMER DID NOT ADMINISTER HIS INSULIN FOR APPROX 4 DAYS. HIS DAUGHTER NOTICED THAT HE WAS EXTREMELY CONFUSED AND "TALKING GIBBERISH". SHE TOOK HIM TO THE ER WHERE, UPON ADMITTANCE, HIS BLOOD GLUCOSE LEVEL WAS 390 MG/DL ON THE HOSP METER (TYPE UNKNOWN). AT THE SAME TIME WITH THE TEST STRIPS THE READING WAS 26 MG/DL. THE HOSP ADMINISTERED INSULIN, ADVISED HIM TO RESUME HIS REGULAR INSULIN REGIMEN AND SENT HIM HOME. THE CUSTOMER'S DAUGHTER CALLED ANOTHER CO TO REPORT THE INCIDENT. CO SENT HER A NEW METER AND REQUESTED THAT SHE SEND THE TEST STRIPS TO THEM FOR EVALUATION. THE CUSTOMER'S DAUGHTER STATED THAT THE CODE WAS SET CORRECTLY IN THE METER AND SHE "THINKS THE DESICCANT WAS IN THE BOTTLE". SHE DID NOT PERFORM A NORMAL CONTROL SOLUTION TEST ON THE TEST STRIP. SHE STATED THAT A CHECK STRIP TEST YIELDED A RESULT THAT WAS IN RANGE (NO SPECIFIC RESULT AVAILABLE). THE CUSTOMER STORES HIS TEST STRIPS IN A ZIPPERED CASE IN THE KITCHEN.
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
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. PNEUMOPERITONEUM LEAKED FROM INSTRUMENT. SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
A REVIEW OF THE CPF HISTORY INDICATED THAT THIS IS THE SECOND ROTOR ON THIS MACHINE. ON CPF #1195053C3 THE ORIGINAL ROTOR ASSEMBLY BROKE DUE TO A BREAKING SPRING. THIS CONDITION IS A KNOWN FAILURE MODE AND A FAR#960018 HAS BEEN GENERATED TO CORRECT THE PROBLEM. THE BLOOD PUMP ROTOR WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE THE MES DISCARDED THE DEFECTIVE ASSEMBLY. HOWEVER, ON COMPLAINTS (0896290C3, 0996032C3, 0996181C3, 099619C3, 1096026C3) IT SHOWS THAT THE ROTOR SPRINGS DO BREAK. THE INDICATIONS ARE THE SAME AS THIS REPORTED CONDITION. THE ABOVE INFO INDICATES THAT THE A/V PRESSURE FLUCTUATIONS DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN ROTOR SPRING. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTIONS SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR# 960018. CUSTOMER CONTACTED: NO, SALES/SERVICE CONTACTED BY INVESTIGATOR? Y. TRAINING REQUIRED? NO.
A 3 X 3 V SHAPED SKIN TEAR OCCURRED ON RESIDENT'S (R) CALF DURING A TRANSFER PROCEDURE FROM WHEELCHAIR TO BATH CHAIR. THE GATCH FOR THE WC FOOT PEDALS IS SUSPECTED TO BE THE CAUSATIVE AGENT. FOOT RESTS WERE NOT USED ON THE RESIDENT'S WHEELCHAIR TO ENCOURAGE INDEPENDENT MOBILITY. THE GATCH SHOULD BE DESIGNED TO SWING BACK OR PUSH IN WHEN FOOTRESTS ARE NOT USED TO PREVENT HITTING LOWER EXTREMITIES OF FRAGILE ELDERLY. PT SUBSEQUENTLY DEVELOPED CELLULITIS AND REQUIRED FOLLOW-UP PHYSICIAN AND MEDICAL TREATMENT. PROTECTIVE VINYL COVERING THAT WRAPS AROUND GATCH DESIGNED BY FACILITY.
DEVICE WAS USED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. INSTRUMENT WOULD NOT FIRE. SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/12/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE COMPRESSOR SHUT OFF DURING INTRA-AORTIC BALLOON PUMPING. THE PT WAS TRANSFERRED TO ANOTHER INTRAORTIC BALLOON PUMP WITHOUT FURTHER INCIDENT. THERE WERE NO PT COMPLICATIONS INVOLVED. THE BIO-MED DEPT AT THE USER FACILITY EVALUATED THE BALLOON PUMP. THE AC RELAY ON THE CONSOLE WAS LOOSE. A RELAY CLIP HOLDER WAS INSTALLED. THE UNIT WAS TESTED AND FUNCTIONED AS INTENDED. THE OPERATING MANUAL OUTLINES THE PROCEDURE FOR CHECKOUT & PREVENTATIVE MAINTENANCE PROCEDURE TO CHECK ELECTRICAL CONNECTIONS DURING PREVENTATIVE MAINTENANCE.
H6-86-DEVICE WAS EVALUATED BY THE BIO-MED DEPT AT THE USER FACILITY. INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. CLIPS SCISSORED AND ONE CLIP FELL FROM THE JAW INTO THE CAVITY. THE SURGEON RETRIEVED THE CLIP WITHOUT INCIDENT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.
11/5/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
THE CUSTOMER IS A FIRST TIME USER OF STRIPS WHO REPORTED LOW READINGS. THE CUSTOMER STATED THAT HIS USUAL READINGS WITH ANOTHER DEVICE ARE IN THE 130-160 MG/DL RANGE. SINCE HE HAS BEEN USING THE TWO TEST STRIPS, HIS READINGS HAVE BEEN VERY LOW, E.G. 65, 62, 93 AND 57 MG/DL. THE CONTACT WAS UNABLE TO PERFORM A NORMAL CONTROL SOLUTION TEST WITH THE REP BECAUSE SHE DID NOT HAVE CONTROL SOLUTION. SHE COULD NOT FIND THE CHECK STRIP FOR THE METER, SO A METER CHECK WAS NOT PERFORMED. THE DESICCANT IS IN THE OPEN BOTTLE. SHE STORES HIS TEST STRIPS IN THE BEDROOM.
CO'S INVESTIGATION OF THIS COMPLAINT HAS NOT BEEN COMPLETED. ESTIMATED TIME TO COMPLETION IS 4 WKS. FURTHER INFO WILL BE PROVIDED AT THAT TIME. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING?U. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE?N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING.U. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE. SUBMISSION OF THE MDR DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. SAFETY SHIELD DID NOT RETRACT. HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/23/96-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
PT HAD SURGERY FOR RUPTURED DOUBLE LUMEN IMPLANTS - OUTER SHELL ONLY WAS RUPTURED WITH SOME GEL BLEED BOTH IMPLANTS. IMPLANTS WERE EXCHANGED FOR SMOOTH SALINE PROSTHESIS.
DEVICE WAS USED DURING A SKIN CLOSURE PROCEDURE. NEEDLE BROKE WHILE PASSING THROUGH TISSUE. NO PT INJURY REPORTED. SURGEON CONTINUED THE PROCEDURE WITH THE SAME SUTURE.
WHEN OPENING A SEALED UNIT, A SYRINGE/NEEDLE CONTAINED DRIED BLOOD. THE SAMPLE WAS NOT USED.
INVESTIGATION IS PROGRESS. EVENT CODE 2200=THE SAMPLE WAS NOT USED; THEREFORE, THERE IS NO PT INVOLVEMENT. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE DISPOSABLE LOADING UNIT WAS USED WITH CO'S ILA 100 STAINLESS STEEL INSTRUMENT DURING A SUB-TOTAL GASTRECTOMY. BLEEDING WAS OBSERVED FROM THE STAPLE LINE. THE SURGEON APPLIED MANUAL SUTURE TO CORRECT THIS CONDITION. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
A REPRESENTATIVE SAMPLE OF THE PRODUCTION LOT IN QUESTION WAS RETURNED FOR EVALUATION. THE DEVICE DISPLAYED AN EXCESSIVE AMOUNT OF LUBRICANT ON THE CARTRIDGE SURFACE WHICH CO HAS DETERMINED DOES NOT HAVE AN EFFECT ON THE PERFORMANCE OF THE DEVICE.
BILATERAL SILICONE BREAST IMPLANT FOUND RUPTURED WHEN ENTERING CAPSULE
DR (VET) REPORTS, THAT A NEW SYRINGE (HEAT SEAL WAS INTACT) HAD BLOOD IN IT. THE SYRINGE WAS NOT USED.
SYRINGE WAS RETURNED AND CONTAMINATE WAS FOUND TO BE BLOOD (9/23/96). INVESTIGATION IS CONTINUING, EVENT CODE 2200- THE SAMPLE WAS NOT USED; THEREFORE, THERE IS NO PT INVOLVMENT. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETED AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE PENCIL ARCED THROUGH THE ELECTROSURGICAL ELECTRODE AND MILDLY BURNED THE PT. NO TREATMENT REQUIRED.
THE HOSPITAL HAS BEEN CONTACTED TO OBTAIN THE ACTUAL SUSPECT DEVICE. NO RESPONSE AT THIS TIME FROM THE HOSPITAL.
11/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITAL REPORT TO FDA.
DEVICE WAS USED DURING A TOTAL KNEE PROCEDURE. SUTURE BROKE AS KNOTS WERE BEING TIED. SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
REMOVAL OF SILICONE GEL IMPLANTS. (R) IMPLANT RUPTURED.
THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 11/5/96. PERFORMANCE TESTING OF THE PENCIL REVEALED THE CUT MODE TO OPERATE AS INTENDED. THE COAG MODEL DID EXHIBIT SOME INTERMITTENT ACTIVATION. THE PENCIL WAS DISASSEMBLED AND A DARK SUBSTANCE (SMOKE LIKE) WAS FOUND ADHERED ON THE INSIDE OF THE DOME  SWITCH WITH A MATCHING MARK OF THE PCB COAG TRACE. MANUFACTURING ENGINEER HAS BEEN INFORMED. THE ROOT CAUSE IS NOT KNOWN AT THIS TIME BUT MAY HAVE BEEN RELATED TO THE ELECTROSURGICAL UNIT.
THE DEVICE WAS USED DURING AN UNSPECIFIED LAPAROSCOPIC PROCEDURE. THE SCOPE'S VISIBILITY WAS NOT CLEAR. THE SURGEON USED A NEW SCOPE. NO PT INJURY WAS REPORTED.
PACEMAKER LEAD BROKE AND HAD TO BE REPLACED.
DEVICE WAS USED DURING AN SKIN CLOSURE PROCEDURE. SUTURE BROKE AND WAS "PARTIALLY ABSORBED". NO PT INJURY REPORTED.
THE DEVICE WAS USED DURNG A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. CLIPS SCISSORED AND ONE CLIP FELL FROM THE JAW INTO THE CAVITY. THE SURGEON RETRIEVED THE CLIP WITHOUT INCIDENT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.
DURING A DIALYSIS TREATMENT, A FOUR POSITION LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD. DURING A DIALYSIS TREATMENT A FOUR POSITION LINE CLAMP BROKE. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL. HOWEVER, ON COMPLAINTS (0896037C3, 0796207C3, 0796157C3, 0796160C3, AND 0796180C3) IT INDICATES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THE FACILITY CLAIMED THAT THIS OCCURRED WITH NORMAL USE. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TREND AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED. IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027. CUSTOMER CONTACTED: Y. DATE: 11/11/96. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? N.
INTERMITTENT PUMP ATTACHED TO GASTRIC TUBE FAILED TO VACUUM AND BILE DRAINED FROM PT'S ABDOMEN ONTO HER SKIN. NO PERMANENT DAMAGE. EQUIPMENT WAS ADJUSTED WITHOUT EFFECT. REPLACED 10/2/96.
THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 11/5/96. PERFORMANCE TESTING OF THE PENCIL REVEALED THE CUT MODE TO OPERATE AS INTENDED. THE COAG MODE DID EXHIBIT SOME INTERMITTENT ACTIVATION. THE PENCIL WAS DISASSEMBLED AND A DARK SUBSTANCE (SMOKE LIKE) WAS FOUND ADHERED ON THE INSIDE OF THE DOME SWITCH WITH A MATCHING MARK OF THE PCB COAG TRACE. MANUFACTURING ENGINEER HAS BEEN INFORMED. THE ROOT CAUSE IS NOT KNOWN AT THIS TIME BUT MAY HAVE BEEN RELATED TO THE ELECTROSURGICAL UNIT.
DEVICE WAS USED DURING AN ORHTOPEDIC PROCEDURE. SUTURE BROKE AND WAS "PARTIALLY ABSORBED". NO PT INJURY REPORTED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE TISSUE. NO PT INJURY REPORTED. THE SURGEON USED ANOTHER DEVICE.
THE IAB WAS INSERTED INTO THE PATIENT TRANSTHORACICALLY. AN ALARM SOUNDED IMMEDIATELY AFTER INITIATION OF IABP. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED INTO THE PATIENT. "MULTIPLE EVENT TO INITIAL COMPLAINT NUMBER 96-00086."
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. NO DEFECT WAS FOUND IN THE RETURNED IAB. INSPECTION OF THE BALLOON DISCLOSED NO DEFECTS. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE DEVICE. DEVICE LABEL CODE: 1738.
DEVICE WAS USED DURING AN ORTHOPEDIC PROCEDURE. SUTURE BROKE AND WAS "PARTIALLY ABSORBED". NO PT INJURY REPORTED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SAFETY SHIELD DID NOT RETRACT WHEN APPLIED TO TISSUE. NO PT INJURY REPORTED. THE SURGEON APPLIED USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
01/14/97- SUPPLEMENTAL REPORT #1 SENT TO FDA. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. DEVICE LABELLING CODE: 1738.
TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL. HOWEVER, ON COMPLAINTS (0896037C3, 1796207C3, 0796157C3, 0796160C3, AND 0796180C3) IT INDICATES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THE FACILITY CLAIMED THAT THIS OCCURRED WITH NORMAL USE. SAFETY ANALYSIS: IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE CS3 OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PATIENT CAN RESULT. FOLLOW-UP ACTION: THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSIS, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027.
DEVICE WAS USED DURING FASCIA CLOSURE. SUTURE BROKE AND WAS "PARTIALLY ABSORBED".  NO PT INJURY REPORTED.
THE BALLOON DEVELOPED A PIN-HOLE LEAK DURING A LEFT ILIAC ANGIOPLASTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATION. THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL REVEALED A PIN-HOLE LOCATED OVER THE PROXIMAL RADIOPAQUE MARKER. THE BALLOON SURFACE WAS SLIGHTLY INDENTED IN THE PROFILE LOCATED PROXIMAL THE DISTAL TIP AND THERE WERE CHATTER MARKS IN THE SAME AREA. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. CO FOLLOW UP INDICATED THIS BALLOON CATHETER WAS USED IN A CALCIFIED LESION AND MAY ALSO HAVE BEEN USED IN CONJUNCTION WITH A STENT. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTANT WITH CONTACT WITH A SHARP EXTERNAL SOURCE, THE BALLOON SURFACE WAS INDENTED AND DISPLAYED CHATTER MARKS, THEREFORE CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: "DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON, THESE BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY".
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA. H6. 86/OTHER-MICROSCOPIC EXAMINATION.
DEVICE WAS USED DURING A TONGUE LIGATION PROCEDURE. SUTURE BROKE WHEN THE PACKAGE WAS OPENED. NO PT INJURY REPORTED.
THE DISPOSABLE LOADING UNIT WAS USED WITH AN INSTRUMENT DURING A WEDGE RESECTION. REPORTEDLY, THE KNIFE AND PUSHER JAMMED DURING FIRING. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/22/96-SUPPLEMENT REPORT #1 SUBMITTED TO FDA.
DEVICE WAS USED DURING A HERNIORRAPHY/BASSINIPLASTY PROCEDURE. SUTURE BROKE WHEN THE PACKAGE WAS OPENED. NO PT INJURY REPORTED.
THE DEVICE WAS USED DURING A TOTAL ABDOMINAL HYSTERCTOMY PROCEDURE. THE STAPLES DID NOT HOLD PROPERLY AND THE STAPLELINE LINE OPENED. THE SURGEON REMOVED THE STAPLES AND MANUALLY SUTURED TO COMPLETE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A BOWEL RESECTION PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO REMOVE FROM THE APPLICATION SITE. THE SURGEON MANUALLY MANIPULATED THE DEVICE OPEN AND COMPLETED THE PROCEDURRE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.  ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
DURING A DIALYSIS TREATMENT, THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE FAILED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
DURING A DIALYSIS TREATMENT, THERE WAS UF (ULTRAFILTRATION) PUMP THERMAL FUSE FAILURE REPORTED. A TECHNICIAN AT THE FACILITY EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF AND CPF HISTORY IS NOT POSSIBLE SINCE THE SERIAL NUMBER IS NOT KNOWN. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. TEST RESULTS/ANALYSIS AND ANY DATE RECORDED: THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 10/28/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED IL. INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSED THE FUSE TO OPEN. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. DUE TO A DELAY IN REPORTING THE INCIDENT, THERE WAS NO FURTHER PT INFO AVAILABLE. THE SERIAL NUMBER OF THE MACHINE THAT WAS REPORTED WAS NOT CORRECT. THE CORRECT SERIAL NUMBER WAS UNK BY THE FACILITY. THEREFORE, NO SEARCHES OF THE HISTORIES OF THE MACHINE MAY BE PERFORMED. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. REFER TO FAR #960016. CUSTOMER CONTACTED: Y. DATE: 11/7/96. SALES/SERVICE CONTACTED BY INVESTIGATOR? N. TRAINING REQUIRED? N.
A BALLOON WOULD NOT INFLATE DURING AN ANGIOPLASTY OF A HIGHLY CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL REVEALED A PIN-HOLE LEAK ONE CENTIMETER PROXIMAL TO THE DISTAL RADIOPAQUE MARKER. THE DEVICE SURFACE DISPLAYED SCRATCHES. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. CO FOLLOW UP INDICATED THAT THE BALLOON SURFACE MAY HAVE BEEN CUT DURING INITIAL ADVANCEMENT BY THE SHARP CALCIFICATION. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES ON THE BALLOON'S SURFACE. IT WAS INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO DEVICE. CO'S DIRECTIONS FOR USE STATE: "BALLOON RUPTURE AT LOWER PRESSURE MAY OCCUR IN STRICTURES EXHIBITING SHARP POINTS DUE TO CALCIFIED MATERIAL OR STAPLES. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY".
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
IT WAS REPORTED THAT ON FIRST DEVICE THE FIBER AND METAL SHAFT BROKE APPROX 1/2 INCH FROM WHITE STICKER LOCATED AT PROXIMAL END. SECOND DEVICE BURNED THROUGH METAL SHAFT APPROX 1 INCH FROM DISTAL END. SOMETIME DURING A KNEE ARTHROSCOPY PROCEDURE, WHILE LASING THE POSTERIOR HORN SECTION OF THE KNEE, THE PHYSICIAN NOTED THAT THE FIBER BURNED THROUGH THE METAL AND THE METAL SHAFT BROKE APPROX 1/2 INCH FROM THE WHITE STICKER (LOT NUMBER/MODEL LABEL LOCATED ON THE PROXIMAL END OF THE EDEVICE) AND BURNED THE PHYSICIAN'S HAND. THE PROCEDURE WAS IMMEDIATELY PAUSED TO REPLACE THE BROKEN DEVICE WITH ANOTHER TIP OF THE SAME MODEL. THE PROCEDURE CONTINUED USING THE SECOND TIP WHEN THE PHYSICIAN NOTED A BURN MARK ON THE METAL SHAFT APPROX 1 INCH FROM THE DISTAL END OF THE DEVICE. AT THE SAME TIME, PHYSICIAN ALSO NOTED (ON VIDEO MONITOR) MINIMAL CHARRED TISSUE. THE PHYSICIAN PROCEEDED TO RESECT THE CHARRED TISSUE WITH A SHAVER. NO FURTHER INCIDENTS OCCURRED DURING PROCEDURE. FOLLOW-UP WITH PHYSICIAN'S ASSOCIATE REGARDING PHYSICIAN'S HAND INDICATED THAT A TOPICAL CREAM WAS USED TO TREAT THE BURN. NO SERIOUS INJURY ASSOCIATED WITH THIS EVENT. NOTE: REPORTER INFORMED MFR THAT EXCESSIVE STRESS MAY HAVE BEEN APPLIED ON THE DEVICE DURING THE LASING PROCEDURE.
NOTE: ALL OF THE INFO ON THIS FORM WAS COMPLETELY BY THE MFR. MULTIPLE ATTEMPTS TO RECEIVE PRODUCT BACK WERE UNSUCCESSFUL.
THE DEVICE WAS USED DURING A HYSTERECTOMY PROCEDURE. THE STAPLES CAME OUT. THE HOSP HAS NOT REPORTED ANY ADD'L INFO.
11/12/96-SUBMISSION OF INITAL REPORT TO FDA.
THE DEVICE WAS USED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. THE STAPLES DID NOT HOLD. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/12/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
PHYSICIAN ERROR: DR USED LASER SYSTEM 694.3 WAVE LENGTH WITH EYEWEAR NOT RECOMMENDED PER DEVICE LABELING BY CO. EYEWEAR (FOR CYNOSURE DYE LASER) CHECKED. NO EVIDENCE OF LASER DAMAGE PER TESTING. DOCTOR + PT EXAMINED TO OPTICAL EXAM; RETINA, AMSER GRID, BOTH OK, NO INJURY. 100CT. INITIAL CALL DID NOT ALLEGE DEATH OR SERIOUS INJURY, ASKED IF THIS WAS OK? CO ADVISED TO HAVE DR, PT, AND EYEWEAR CHECKED.
ON OCT 10, (INITIAL REPORTER) CONTACTED AND STATED DR. PT, AND EYEWEAR ALL CHECKED FINE, NO INJURIES. FROM 10 OCT THROUGH 29 OCT, CO ATTEMPTED (10) ADD'L CONTACT TO OBTAIN INFO IN WHICH TO ADDRESS EVENT WITH DUE DILIGENCE, SITE WAS UNCOOPERATIVE REFERRED TO FACILITY MANAGER; ALSO PROVED UNRESPONSIVE. ON 22 OCT, QUALITY MANAGER AT 1.45 PM LOGGED. HE ADVISED INITIAL CONTACT DID NOT ALLEGE MDR EVENT, NO INJURY OR ALLEGATIONS THERE OF, HE STATED NON MDR EVENT. COMPLAINT INITALLY CLOSED. NON MDR EVENT, HOWEVER, INFO DOES SUGGEST THAT USER ERROR COULD RESULT IN THAT USER ERROR COULD RESULT IN SERIOUS INJURY. DECISION  MADE TO FILE MDR REPORT OF USER ERROR ON 11/7/96.
DURING AN ILIAC DILATAION PROCEDURE THE CATHETER BALLOON RUPTURED AFTER THE SECOND INFLATION. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS BEING REPORTED.
PT ARRIVED FROM HOME FOR REPLACEMENT OF THE INDWELLING CATHETER. ORIGINAL CATHETER, UPON VIEWING VIA FLOUROSCOPY, WAS FOUND TO BE IN THREE (3) PIECES AND NOT IN THE CORRECT POSITION. VASCULAR SURGEON WAS UNABLE TO RETRIEVE ALL OF TEH CATHETER THAT WAS IN THE RIGHT ATRIUM. AN INTERVENTIONAL RADIOLOGIST RETRIEVED CATHETER VIA FEMORAL ARTERY.
A USER MEDWATCH REPORT WAS RECEIVED BY CO ON 10/17/96. THE REPORT WAS AS FOLLOWS: WHEN ATTEMPTING TO GO ON BYPASS, THE VENOUS LINE WAS CONNECTED AND RETURN FLOW WAS OBTAINED. ARTERIAL LINE WAS CONNECTED AND DID NOT FLOW, THE FILTER WAS CLAMPED OFF AND THE BYPASS LINE WAS OPENED AND FLOW TO THE PT WAS STARTED. THE CASE PROCEEDED AND COMPLETED.
PRODUCT WAS SENT TO VENDOR FOR EVAL. THE PEDIATRIC ARTERIAL BLOOD FILTER WAS SENT TO CO FOR AN EVAL. THE RESULTS ARE AS FOLLOWS: "THE FILTER WAS PRIMED WITH WATER AND TESTED WITH A CONTINUOUS FLOW RATE UNDER THE OBSERVATION OF TECHNICAL STAFF. THE WATER FLOWED FREELY THROUGH THE FILTER IN QUESTION WITH NO ANOMALIES NOTED. VISUAL EXAM NOTED NO PHYSICAL DAMAGE TO THE FILTER. THE FILTER WAS THEN FORWARDED TO CO RESEARCH AND DEVELOPMENT LAB FOR FURTHER TESTING WITH BOVINE BLOOD. THE FILTER WAS PRIMED AND TESTED FOR PRESSURE DROP AT 1,2, AND 3 LPM. FLOW THROUGH THE FILTER APPEARED NORMAL AT EACH FLOW RATE. IN SUMMARY, THE BLOOD FILTER APPEARED TO BE NORMAL WITH NO ANOMALIES NOTED DURING THE EVAL." GISH BIOMEDICAL, INC. HAS REPORTED THIS EVENT PURSUANT TO 21 CFR PART 803, BASED ON INFORMATION RECEIVED BY GISH BIOMEDICAL, INC. THE SUBMISSION OF THIS REPORT BY GISH BIOMEDICAL, INC., SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED, NOR SHALL THE SUBMISSION BE CONSTRUED AS AN ADMISSION BY GISH BIOMEDICAL, INC. THAT THE PRODUCT DESCRIBED HEREIN IS OR WAS DEFECTIVE IN ANY RESPECT OR THAT ANY CAUSAL RELATIONSHIP EXISTS BETWEEN THE PRODUCT AND ANY ACTUAL OR POTENTIAL INJURY.
PT ADMITTED TO SAME DAY SURGERY UNIT FOR REPLACEMENT OF PACEMAKER GENERATOR. IMPLANTED 3/25/93.
ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT # T041) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPEC. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPEC. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. PRODUCT WITHIN SPEC.
THE DEVICE WAS USED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCDURE. THE TAPLELINE DID NOT HOLD. THE SURGEON OVERSEWED THE APPLICATION SITE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A LEFT PROFONDA DILATATION PROCEDURE, THE CATHETER BALLOON RUPTURED. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE. THE PROCEDURE WAS COMPLETED USING A THIRD CATHETER OF THE SAME MAKE WITH NO PT INJURY REPORTED.
ON 10/2/96 DURING SURGICAL PROCEDURE, WHILE INSERTING FEMORAL NAIL, THE ASSEMBLY TWISTED CAUSING DAMAGE TO JIG.
H6-REVIEW OF PRODUCTION RECORDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE DATA INDICATES THAT ALL PRODUCTS WITHIN THESE LOTS WERE MFG IN     CONFORMANCE WITH ALL DESIGN REQUIREMENTS. THE RETURNED DEVICES WERE EVALUATED AND THEY MET SPECIFICATIONS P/N 1146, THE HOLE IS WORN, HOLE WHERE THE OFFSET IMPACTOR BLOCK SEATS AND THE KEY SLOT IS BROKE. P/N 1232, RECEIVED AND THE PIN IS WORN. P/N 1001, THE CUTTING FLUTES WERE DULL. BASED ON CO INVESTIGATION CO WAS UNABLE TO DETERMINE HOW THIS EVENT OCCURRED.
THE DEVICE WAS USED DURING A PROTOCOLECTOMY PROCDURE. THE INSTRUMENT WOULD NOT FIRE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/13/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9.  DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
THE IAB WAS INSERTED INTO THE PATIENT WITH A SHEATH UNDER FLUOROSCOPY. THE DOCTOR WAS NOT ABLE TO INFLATE THE IAB EVEN WITH A SYRINGE. THE IAB WAS REMOVED AND A SECOND WAS INSERTED. THE IAB WAS NOT RETURNED TO THE CO. FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO THE CO. FOR EVALUATION. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED.
ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT # S0076) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPEC. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROX WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPEC. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR IMPROPER TECHNIQUE AND/OR MATERIALS. PRODUCT WITHIN SPEC.
REFERENCE MFR COMPLAINT #Z96-309. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. MANUFACTURING EVALUATED RETAINED SAMPLE FROM THE SAME LOT NUMBER. NO DEFECT WAS OBSERVED, EVEN UNDER 20X MAGNIFICATION. NO LOOSE OR EASILY DETACHABLE PLEDGETS WERE DETECTED. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED ON THE COMPLAINT LOT. CO IS UNABLE TO DETERMINE EXACT CAUSE OF INCIDENT AS THE ACTUAL DEVICE WAS NOT AVAILABLE FOR EVALUATION.
THE DEVICE WAS USED DURING A TOTAL HYSTERECTOMY PROCEDURE. THE STAPLES DID NOT HOLD. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
NO APPARENT PRODUCT ANOMALIES CONTRIBUTING TO THE PROBLEM. INSUFFICIENT INFO AVAILABLE TO DETERMINE PRECISE CAUSE OF THE PROBLEM. A POSSIBLE CAUSE IS EXCESSIVE LATERAL FORCE APPLIED DURING STONE REMOVAL PROCEDURE.
THE PT'S EXPLANTED DEVICE WAS RETURNED TO MFR. THE DEVICE HAD REPORTEDLY EXTRUDED. NO OTHER INFO WAS MADE AVAILABLE. MFR HAS CONTACTED THE IMPLANT CENTER FOR ADD'L INFO. THE CHILD WAS NOT REIMPLANTED. THE HEALTHCARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEVICE SHOULD BE RETURNED TO MFR.
USER RESPONDED TO HOME OF 77 Y/O MALE WHO WAS REPORTED AS UNCONSCIOUS. UPON ARRIVAL, PT WAS CONCIOUS AND ALERT. DEVICE WAS CONNECTED TO MONITOR THE PT AND USER ALLEGES DEVICE DISPLAYED ERRONEOUS FLAT LINE DATA. NO ADVERSE AFFECT TO THE PT WAS REPORTED. CONDITION WAS DUPLICATED BY SERVICE REP. DEVICE WAS REPAIRED AND PROPER OPERATION CONFIRMED.
SECTION A.1 PT IDENTIFICATION NOT PROVIDED. A.4 PT WEIGHT NOT PROVIDED. SECTION B.7 RELEVANT PT HISTORY NOT PROVIDED. SECTION H.3 EVAL SUMMARY. SERVICE REP WAS ABLE TO DUPLICATE REPORTED CONDITION. CPU BOARD WAS REPLACED AND PROPER OPERATION WAS CONFIRMED. AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THE TIME, BUT WILL BE MONITORED PERIODICALLY.
EVENT COMPLICATIONS: UNK - REPORTED 9/3/96. PATIENT'S CURRENT STATUS: UNK - RPT'D 9/3/96.
DURING AN SFA DILATION PROCEDURE, THE CATHETER BALLOON RUPTURED AFTER THE THIRD INFLATION. THE CATHETER WAS REMOVED AND REPLACED WITH SAME MAKE TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS BEING REPORTED.
BLOCK B6 & B7 WERE CHANGED TO "UNK" AS SEVERAL ATTEMPTS WERE MADE TO NO AVAIL OF FAINING THE INFORMATION.
WHILE UNDERGOING A TURP, PT RECEIVED SEVERAL ELECTRICAL JOLTS WHILE A LITHOTRIPTER WAS IN USE FOR REMOVAL OF BLADDER STONES. PT LIFTED OFF THE TABLE WHEN EHL PROBE PLACED IN VICINITY OF THE STONE.
THIS DISTRIBUTOR BECAME AWARE ON 10/29/96 OF AN INCIDENT THAT OCCURRED DURING A RENAL ANGIOPLASTY PROCEDURE. RESISTANCE WAS ENCOUNTERED ADVANCING A BALLOON CATHETER OVER THE WIRE. CONTINUED MANIPULATION RESULTED IN THE GUIDE WIRE PERFORATING A BRANCH OF THE RENAL ARTERY. A HEMATOMA IN THE PERI-RENAL SPACE RESULTED. THE PT REQUIRED TWO UNITS OF BLOOD AND WAS HOSPITALIZED FOR TWO DAYS. THE PT'S CONDITION IS GOOD. USER TECHNIQUE AND/OR PT ANATOMY MAY HAVE BEEN CONTRIBUTING FACTORS IN THIS EVENT. HOWEVER, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
RISK MANAGER AT CENTER, WAS CALLED 4/11/96. INQUIRY ELICITED THE FACT THAT A DISPERSIVE ELECTRODE WAS LEFT ON THE PT AND THAT THE PT WAS THEREFORE GROUNDED. RISK MANAGER AGREED TO REMIND ALL PHYSICIANS OF THE CAUTION IN THE OPERATING MANUAL: "REMOVE ANY ELECTROSURGICAL UNIT DISPERSIVE ELECTRODE (GROUNDING PAD OR PT PLATE) WHICH HAS BEEN APPLIED."
#16 FR URINARY CATHETER INSERTED INTO THE URINARY BLADDER. PT WENT TO RADIOLOGY. PROCEDURE REQUIRED FILLING THE URINARY BLADDER WITH NORMAL SALINE. THE CATHETER CAME OUT OF THE URETHRA. THE RETENTION BALLOON ON THE CATHETER APPARENTLY FAILED.
THE DEVICE WAS REMOVED DUE TO THE "PUMP RUPTURED TUBING FROM RESERVOIR. THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
QA WAS UNSUCCESSFUL IN SECURING THE DEVICE FOR EVALUATION SINCE IT WAS DESTROYED BY THE HOSP. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANTED DEVICE, QA IS PRECLUDED FROM CONFIRMING THE PHYSICIAN'S OBSERVATIONS AND PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE.
THE NEW SHEATHLESS GUARD ON THE CATHETER TAKES UP TOO MUCH ROOM THAT MAKES IT VERY DIFFICULT TO ADVANCE THE CATHETER INTO THE CORRECT PLACE.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO THE CO. FOR EVALUATION. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED.THIS FORM WAS COMPLETED BY THE MANUFACTURER.
UPON START OF STUDY TECHNOLOLGIST STATED THAT NO COUNTS WERE OBSERVED AND WENT BACK TO MAIN CONSOLE, MAIN MENU AND PRESSED STATIC. TECH NOTICED THAT CAMERA STARTED ROTATING CLOCKWISE AND PRESSED EMERGENCY STOP WITH NO EFFECT. COLLIMATOR CONTACTED PT'S CHEST BUT TECH PULLED HER OFF TABLE.
ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT # S0261) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPEC. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPEC. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. PRODUCT WITHIN SPEC.
DURING COLONSCOPY, THE SCREW TIP OF THE COLONFIBERSCOPE FELL OFF INSIDE THE PT. THE PT WAS SUBSEQUENTLY ADMINISTERED GENERAL ANESTHESIA IN ORDER FOR THE SURGEON TO REMOVE THE PIECE. THERE WAS NO PT INJURY. HOSPITAL PERSONNEL CAN NOT CONFIRM IF THE TIP WAS LOOSENED WITH MANIPULATION OF THE SCOPE.
FIRST REPORTED 10/15/96 BY PURCHASING AS A BALLOON RUPTURE. MEDWATCH REC'D 10/22/96 W/INFO STATING ENTIRE BALLOON DETACHED FROM CATHETER. TO DATE, 3 UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. REPORT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT AS DEFINED BY THE REGULATIONS. MAXIMUM INFLATION CAPABILITIES FOR 5CC CATH IS 10CC OF STERILE WATER PER LABELING.
THE DOCTOR REMOVED THE CLEAR HEMOSTASIS VALVE FROM THE SHEATH BELIEVING IT TO BE JUST THE INTRODUCER DILATOR. THERE WAS EXCESS BLEEDING FROM THE SHEATH.
THE USER FACILITY SENT A COPY OF THE MEDWATCH FORM TO ONE SECTION OF CO TO REPORT THE EVENT DESCRIBED ABOVE. A DIFFERENT REPORT WAS SENT TO THE CO REPAIR CENTER AND THE INFO ON THE REPORT READS AS FOLLOWS: "PLEASE CHECK OUT FOR ANY NEEDS OF REPAIR AND/OR MAINTENANCE ESPECIALLY END SCREW TIP. CALL: QUOTES". DUE TO THE AGE OF THE SCOPE, 5 YRS PLUS, A COMPLAINT REPORT WAS NOT COMPLETED BY THE REPAIR CENTER BECAUSE THE PROBLEM WAS CONSIDERED TO BE DUE TO NORMAL WEAR AND TEAR. THEREFORE, THE SCOPE CANNOT BE EVALUATED BECAUSE IT HAD ALREADY BEEN REPAIRED AND RETURNED TO THE CUSTOMER PRIOR TO  RECEIVING THE MEDWATCH REPORT IN REGULATORY AFFAIRS.
DURING A LAP BURCH PROCEDURE, THE NEEDLE BROKE AS IT WAS BEING PASSED THROUGH TISSUE. NO PT INJURY REPORTED.
11/6/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT OF FDA.
ELECTRONIC TESTING OF ATHE RETURNED SENSOR (LOT # S132) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPEC. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPEC. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. PRODUCT WITHIN SPEC.
CUSTOMER FOUND A NEW NEEDLE WITH BROWN (POSSIBLY BLOOD) CONTAMINATED RESIDUE IN THE NEEDLE. A TECH FOUND THE NEEDLE, IT WAS NOT USED.
PRELIMINARY EVALUATION INDICATES THE SUBSTANCE IN THE NEEDLE IS BLOOD. THE INVESTIGATION IS STILL IN THE PROGRESS. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFORMATION NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE IAB WAS INSERTED INTO THE PATIENT ON 8/26/96. ON 9/1/96, BLOOD WAS NOTED IN THE TUBING AND THE IAB WAS REMOVED. A SECOND WAS INSERTED INTO THE PATIENT.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICRSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. (DEVICE LABELING CODE: 1738)
A DISTRIBUTOR REPORTED THAT ONE ANALYZER WAS FOUND TO HAVE ITS OPTICAL FILTERS INTERCHANGED. THIS WAS FOUND DURING THEIR INCOMING INSPECTION. INVESTIGATION OF THIS INCIDENT DETERMINED THAT THE ORDER OF THESE FILTERS, IF INTERCHANGED COULD AFFECT THE ACCURACY OF PT READINGS. A PROCESS HAS BEEN IMPLEMENTED IN MFG TO INSURE EACH PARAMETER IS PAIRED WITH ITS CORRESPONDING OPTICAL FILTER.
SECTION H.3 EVAL SUMMARY ATTACHMENT-INVESTIGATION OF THE DESCRIBED SITUATION, DETERMINED THE ACCURACY OF PT READINGS COULD BE AFFECTED IF THE OPTICAL FILTERS WERE INTERCHANGED. A PROCESS HAS BEEN IMPLEMENTED BY THE MFR TO INSURE EACH PARAMETER IS PAIRED WITH ITS CORRESPONDING OPTICAL FILTER. SEE DISCLAIMER.
DURING AN UNSPECIFIED PROCEDURE, THE SUTURE AND NEEDLE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE.
11/7/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. CO FOREIGN SUBSIDIARY WAS INFORMED OF THIS EVENT ON 9/19/96; HOWEVER, CORPORATE WAS NOT INFORMED UNTIL 10/29/96. SUBSEQUENTLY, THE 30 DAY REQUIREMENT FOR REPORTING WAS EXCEEDED. CO FOREIGN SUBISIDIARY WILL BE RE-INSTRUCTED.
THE ACCOUNT OBTAINED A WEAK POSITIVE RESULT ON SERUM WITH HCG DEVICE KIT AND SERUM QUANTITATION RESULT OF 2.9 ON THE DEVICE. THE EMERGENCY ROOM DOCTOR STATED THE PT WAS NOT PREGNANT PER PHYSICAL EXAM. A RANDOM URINE WAS RUN ON THE SAME KIT AND A NEGATIVE RESULT WAS OBTAINED. THE SERUM WAS REPEAT TESTED AND THE SAME WEAK POSITIVE RESULT OCCURRED. THE HCG RESULT WAS NOT REPORTED. A PELVIC ULTRASOUND WAS DONE BUT THE ACCOUNT DOES NOT HAVE ACCESS TO THOSE RESULTS.
MFR REPORT NUMBER HAS BEEN CORRECTED TO 14151914-1996-00004 FROM 14151914-1996-00003. EVALUATION COMPLETE-FINAL REPORT.
TECH WAS PARKING GANTRY W/PINHOLE, WAS LOWERING DETECTOR ON COLLIMATOR CART, A USUAL END OF THE DAY PROCEDURE, AS WEIGHT WAS ABSORBED BY CART, CUSTOMER HEARD LOUD BANG AND RATTLE, BUT NO MOVEMENT. FIELD SVC TECH FOUND A BROKEN SHAFT.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, THE STAPLELINE WAS IMCOMPLETE. SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/7/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
DURING AN UNSPECIFIED PROCEDURE, THE CLIPS DID NOT ADVANCE PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
09/10/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
THE DEVICE WAS USED DURING A PNEUMONECTOMY. THE STAPLES DID NOT FORM. THERE WAS NO CONSEQUENCE TO THE PT.
DURING AN UNSPECIFIED PROCEDURE, THE SUTURE BROKE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. THE STAPLES DID NOT LOCK. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
ELECTRICAL CORD CONNECTION SPARK". AS THE PUMP WAS PLUGGED IN IT BEGAN TO SPARK. THERE WAS NO PT INVOLVEMENT, THE NURSE WAS SETTING UP THE PUMP. THE NURSE WAS, AT MOST, THE LENGTH OF THE POWER CORD AWAY FROM THE PUMP. THE NURSE WAS NOT INJURED.
INVESTIGATION IS IN PROGRESS. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFORMATION NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
THE DEVICE WAS USED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. THE STAPLE DID NOT LOCK. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE ER320 WAS BEING USED TO LIGATE THE CYSTIC ARTERY, WHEN IT WAS OBSERVED THAT THE CLIPS WERE FALLING OFF THE VESSELS. BLEEDING WAS PRESENT. A SECOND ER320 WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6;H4: INFORMATION UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS SCISSORED. THE SURGEON REMOVED THE CLIPS AND APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION RESULTS WITH TEST STRIPS, LOT # 1K502A. SHE OPENED THE BOTTLE ON 10/15/96 AND PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 112 MG/DL. BECAUSE THIS RESULT WAS OUT OF THE NORMAL CONTROL SOLUTION RANGE, SHE IMMEDIATELY PERFORMED A SECOND NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 111 MG/DL. THE SOLUTION (LOT #VK284: EXP. 11/96) WAS OPENED FOR THE FIRST TIME ON 10/15/96 AND THE CUSTOMER SHOOK IT WELL BEFORE TESTING. THE METER WAS SET TO THE APPROPRIATE CODE FOR ALL TESTS. THE DESICCANT IS IN THE BOTTLE OF TEST STRIPS. WITH THE CO REP, THE CUSTOMER PERFORMED ANOTHER NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 120 MG/DL. A CHECK STRIP TEST WAS ALSO PERFORMED WITH THE REP AND THE RESULT WAS 78 VERSUS A CHECK STRIP RANGE OF 68-97. THE CUSTOMER STORES THE TEST STRIPS IN THE BEDROOM. THE CUSTOMER HAS A SECOND BOX OF TEST STRIPS, SAME LOT #, WHICH ARE READING OUT OF THE HIGH END OF THE NORMAL CONTROL SOLUTION RANGE (SPECIFIC RESULTS UNK). THE SECOND BOX WAS OPENED APPROXIMATELY 2 WEEKS AGO AND THE DESICCANT IS IN THE BOTTOM. THE CUSTOMER DID NOT HAVE THE SECOND BOX AVAILABLE TO PERFORM ANOTHER CONTROL SOLUTION TEST.
CO CONFIRMED CUSTOMER'S COMPLAINT OF OUT OF CONTROL RANGE ON 10/30/96. THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 10/30/96. SIX BOTTLES WITH DESICCANT, THREE OPENED AND THREE UNOPENED, WERE RETURNED TO CO FOR EVALUATION. THE NORMAL CONTROL READINGS FROM ONE OF THE OPENED BOTTLES AND TWO OF THE UNOPENED BOTTLES WERE BELOW THE SPECIFIED CONTROL RANGE. THE NORMAL CONTROL READINGS FOR THE REST OF THE THREE RETURNED BOTTLES WERE WITHIN THE CONTROL RANGE. EVALUATION OF THE DESICCANTS INSIDE THE RETURNED BOTTLES INDICATES THAT THE LOW NORMAL CONTROL READINGS FROM THE RETURNED STRIPS MAY NOT BE DUE TO EXPOSURE TO MOISTURE. THE RETENTION SAMPLE TEST RESULTS FOR LOT 1K502A CONTINUE TO PROVIDE ACCEPTABLE PERFORMANCE. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? U. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? N. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? Y. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? N. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
REPORT OF ALLEGED ALL LEDS CAME ON, NO VOLUME DELIVERED, UNK IF UNIT ALARMED. FOUND DURING BENCH TESTING. NOT IN PT USE".
TESTING BY MFR FOUND DEVICE FOLLY FUNCTIONAL. LABELING #1738.
THE DEVICE WAS USED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCDURE. THE STAPLES WOULD NOT HOLD. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. SOME CLIPS DON'T CLOSE IN THE SAME WAY. THERE WAS NO CONSEQUENCE TO THE PT.
THE DEVICE WAS USED DURING A COELIOSCOPIC INGUINAL HERNIA PROCEDURE. THE INSTRUMENT DID NOT FIRE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
ADD'L INFO WAS RECEIVED WITH REGARD TO THE OCCURRENCE OF SURGICAL INTERVENTION (SEE SECTIONS B2;B3;D6;D8;G4;H1;H2;H3;H7;H10.). EVALUATION IS PENDING DECONTAMINATION, EXAMINATION AND TESTING OF THE RETURNED DEVICE COMPONENT(S). ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 10/2/87 AND REVISED ON 9/18/96 DUE TO "FLUID LOSS." A PUMP AND TWO CYLINDERS WERE RETURNED FOR EVAL. IN THE RECEIVED INFO THE MD STATED THAT "SIX MONTHS AGO, THE PUMP REMAINED COLLAPSED, INDICATING THAT THERE WAS NO FLUID IN THE SYSTEM." THE MD ALSO STATED THAT "THE INPUT TUBING WAS THEN DIVIDED, THE CYLINDERS AND PUMP REMOVED,...THE RESERVOIR AND CONNECTORS IN THE INFRAPUBIC AREA REMAIN IN SITU." EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED NO FUNCTIONAL ABNORMALITIES, HOWEVER THE CONNECTORS AND ASSOCIATED TUBING FROM BETWEEN THE CYLINDERS AND PUMP WAS NOT RETURNED AND THEREFORE COULD NOT BE EXAMINED. BECAUSE THE AVAILABLE INFO DID NOT INDICATE WHAT FACTOR(S) MAY HAVE CONTRIBUTED TO THE REPORTED "FLUID LOSS," BECAUSE NO FUNCTIONAL ABNORMALITIES WERE OBSERVED, AND BECAUSE QA DID HAVE THE BENEFIT OF ANALYZING THE REMOVED CONNECTORS, QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED EVENT.
THE DEVICE WAS REMOVED DUE TO A "FLUID LOSS". THE CYLINDER(S) AND PUMP COMPONENTS ONLY WERE REMOVED AND REPLACED WITH CO'S DEVICE COMPONENT(S). THE RESERVOIR ORIGNALLY IMPLANTED ON 10/2/87 WAS LEFT IN PLACE.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. THE INSTRUMENT WAS FIRED FOR THE FIRST-TIME (NOT RELOADED) AT THE LOWER PART OF THE SIGMOID COLON. AFTER FIRING AND CUTTING ON THE PROXIMAL SIDE OF THE TL60 THE INSTRUMENT WAS OPENED JUST TO FIND THAT THERE WERE NO STAPLES. THE SURGEON NOW HAD TO HAND SEW THE OPENING. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION BASED ON INFO RECEIVED AND VISULA AND FUNCTIONAL RESULTS, IT COULD NOT BE DETERMINED AS TO WHAT MAY HAVE OCCURRED DURING SURGERY. INSTRUMENT WAS RETURNED WITH ORIGINAL CARTRIDGE AND WAS FULLY LOADED WITH STAPLES. INSTRUMENT WAS FIRED WITH RETURNED CARTRIDGE AND FIRED AND FORMED STAPLES AS DESIGNED WITH NO DIFFICULTIES NOTED. THEREFORE, IT COULD NOT BE ASCERTAINED AS TO WHY IT WAS REPORTED THAT THERE WERE NO STAPLES IN STAPLER. INSTRUMENT WAS ALSO DRY-FIRED SEVERAL TIMES AND DRIVERS PUSHED FORWARD THROUGH CARTRIDGE DURING EACH FIRING. THEREFORE, IT COULD NOT BE DETERMINED AS TO WHY STAPLES DID NOT DELIVER DURING FIRING AS IT WAS CONFIRMED THAT THEY WERE ALL PRESENT. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF REPORTED INCIDENT.
THE DEVICE WAS USED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE. THE STAPLES WOULD NOT HOLD. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A TONSILLECTOMY, THE THUMB LATCH SPRING WAS CRACKED. THE PROCEDURE WAS DELAYED LONG ENOUGH TO SWITCH TO A DIFFERENT INSTRUMENT.
THE DEVICE WAS USED DURING A PROTOCOLECTOMY PROCEDURE. THE INSTRUMENT WOULD NOT FIRE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS SCISSORED. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A LAPARSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS SCISSORED. THE SURGEON REMOVED THE CLIPS AND APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A LAPAROSCOPIC CHOLOECYSTECTOMY PROCEDURE, THE CLIPS SCISSORED. THE SURGEON REMOVED THE CLIPS AND APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE HOSPITAL REPORTED THAT THE TIP OF THE CLEANING BRUSH FELL OFF INTO THE BRONCHOSCOPE DURING CLEANING BUT WENT UNDETECTED BY HOSPITAL PERSONNEL. WHEN THE BRONCHOSCOPE WAS USED DURING A PROCEDURE, THE TIP OF THE BRUSH CAME OUT OF THE SCOPE AND FELL INTO THE PT'S LUNG. THE PIECE WAS RETRIEVED WITH A BIOPSY FORCEPS AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE SCOPE IS STILL IN USE SINCE IT WAS DETERMINED BY HOSPITAL PERSONNEL THAT THE SCOPE WAS NOT THE CAUSE OF THE PROBLEM.
SINCE THE CUSTOMER HAS NOT RETURNED THE CLEANING BRUSH FOR EVALUATION, CO IS UNABLE TO DETERMINE THE REASON FOR THE DETACHMENT. IF AT ANY POINT THE BRUSH IS RETURNED, THE COMPLAINT WILL BE REOPENED AND A COMPLETE INVESTIGATION WILL BE CONDUCTED.
THE INSTRUMENTS WERE USED DURING A LAPAROSCOPIC BURCH PROCEDURE. THE INSTRUMENTS WERE HANDED TO REP IN THE PACKAGING WITH "BROKEN" WRITTEN ON ONE OF THE BOXES. SURGEON MAY HAVE DRY-FIRED THE INSTRUMENTS. ANOTHER INSTRUMENT OBTAINED. THERE WAS NO CONSEQUENCE TO THE PT.
A1, 2,3,4; B,6,7; D 10: INFO UNAVAILABLE 10/17/96 1450 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/18/96 NNCL SENT. D5; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. INFO FOR DEVICE #2 IS THE SAME EXCEPT D6. LOT # J4B005. BATCH # H0058A. CONCLUSION: THE REPORTED INST WAS "BROKEN" DURING SURGERY MAY HAVE BEEN DUE TO AN INVERTED STAPLE IN THE CARTRIDGE NOSE WHICH CAUSED THE INST TO JAM. THE INST WAS RECEIVED WITH THE LAST STAPLE INVERTED AND JAMMED IN THE CARTRIDGE NOSE. THERE WAS EXCESSIVE DRIED BODY FLUIDS AND TISSUE IN THE CARTRIDGE ASSEMBLY. THE INVERTED STAPLE WAS REMOVED FROM THE CARTRIDGE NOSE AND NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE INSTRUMENT BEING EMPTY. NO CONCLUSION COULD BE REACHED AS TO HOW THE LAST STAPLE HAD BECOME INVERTED. THE INSTRUMENT WAS CONFORMING WITH REGARD TO STAPLES FEEDING, FIRING AND FORMING. THE INST, WAS REC'D IN GOOD PHYSICAL CONDITION AND WAS EXAMINED AND FOUND TO BE FUNCTIONAL. THE INST. WAS CYCLED AND FIRED THE REMAINING 20 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT WAS "BROKEN" DURING SURGERY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY.
DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION, PNEUMOPERITONEUM LEAKED FROM THE INSTRUMENT. THE SURGEON USED ANOTHER DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/13/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. CORRECTIVE DATA ENTERED IN D9.  DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
THE DEVICE WAS DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE ER420 CLIPS FELL OUT OF THE JAWS OF THE DEVICE. A SECOND DEVICE WAS INTRODUCED AND THE CLIPS FED INTO THE JAWS SIDEWAYS. THE DEVICES PERFORMED SUFFICIENTLY TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7;D5,10;H4: INFO UNAVAILABLE. 10/17/96 1103 WAS ASKED TO CALL SURGEON BACK AFTER 1:30PM. 10/17/96 1447 MESSAGE AND 800 # LEFT FOR MD CALL BACK. 10/18/96 NNCL SENT. INFO FOR D1 THROUGH D10 IS THE SAME FOR INSTRUMENT #2. INFO H1 THROUGH H10 IS THE SAME FOR INSTRUMENT #2, EXCEPT H6. H6: 10 36 38 708 1023 NA NA 67 71 78. CONCLUSION: BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT A WAS RETURNED WITH TOO MUCH LUBRICANT IN THE SHAFT ASSEMBLY. INSTRUMENT A WAS CYCLED AND FORMED THE CLIPS WITHIN DESIGN SPEC, BUT HAD A SLOW FEED DUE TO EXCESSIVE LUBRICANT. THE LUBRICANT WAS APPLIED IMPROPERLY DURING THE ASSEMBLY RPOCESS. INSTRUMENT B WAS RETURNED IN GOOD PHYSICAL CONDITION. INSTRUMENT B WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPEC.
DURING A MYOMECTOMY PROCEDURE, THE SUTURE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
THE EZ35W WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE SURGEON FIRED THE DEVICE OVER THE BASE OF THE APPENDIX AND HAD SIGNIFICANT BLEEDING ONCE HE RELEASED THE INSTRUMENT. 10/15/96 ELECTROCAUTERY WAS USED TO CONTROL THE STAPLE LINE BLEEDING. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7;D5,10;H4: INFO UNAVAILABLE. 10/17/96 1005 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/18/96 NNCL SENT. CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY PRODUCED "STAPLE LINE BLEEDING" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE RETURNED CARTRIDGE WAS MISSING THE LOCKOUT TAB AND WITH TWO BROKEN ALIGNMENT FINGERS. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
THE EZ35W WAS USED DURING AN LAVH. THE DEVICE JAMMED AFTER SECOND FIRING. THE SURGEON COULD NOT SQUEEZE THE BLACK FIRING TRIGGER. 10/15/96 THE CASE WAS COMPLETED WITH ANOTHER EZ35. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D5, 10; H4: INFO UNAVAILABLE. 10/17/96 1002 MESSAGE AND 800# LEFT ON SURGEON'S PM. HE WILL BE BACK IN THE OFFICE ON MONDAY AM. 10/23/96 NNCL SENT. CONCLUSION: BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, THE STAPLELINE WAS IMCOMPLETE. THE SURGEON MANUALLY SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A BURCH PROCEDURE, INSTRUMENT BROKE. NO PT INJURY REPORTED.
DEVICE NOT EVALUATED BY MFR INDICATED IN H3. APPROPRIATE CODES ENTERED IN H6.
DURING AN UNSPECIFIED GYNECOLOGICAL LAPAROSCOPIC PROCEDURE, THE SLEEVE DISENGAGED. THE SURGEON APPLIED ANTOHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/8/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
DURING A HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT CLOSE PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED TAHT NO PT INJURY OCCURRED.
DURING A DIAGNOSTIC LAPAROTOMY, THE SAFETY SHIELD DID NOT RETRACT DURING PENETRATION. THE SURGEON USED ANOTHER DEVICE. NO PT INJURY REPORTED.
DURING A LAPAROSCOPY, THE SAFETY SHIELD DID NOT RETRACT WHEN APPLIED TO TISSUE. THE SURGEON APPLIED ANOTHER DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A LAPAROSCOPY, THE SAFETY SHIELD DID NOT RETRACT WHEN APPLIED TO TISSUE. THE SURGEON APPLIED ANTHER DEVICE. THE HSOP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/05/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. CORRECTED DATA ENTERED IN D9. DEVICE EVALUATED AND CODES ENTERED IN H3 AND H6.
DURING AN UNSPECIFIED PROCEDURE. PNEUMOPERITONEUM LEAKED FORM THE DEVICE. NO PT INJURY REPORTED.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SAFETY SHIELD DID NOT ADVANCE AFTER PENETRATION. THE HOSP HAS RPEORTED TAHT NO PT INJURY OCCURRED.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SAFETY SHIELD DID NOT ADVANCE AFTER PENETRATION. THE HOSP HAS REPORTED THAT PT INJURY OCCURRED.
DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON USED AONTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE IMPLANT WOULD NOT ALIGN AS PER TRIAL. THERE WAS NO ADVERSE CONSEQUENCE  FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE RESULTS OF THE MANUFACTURER'S EVALUATION ARE INCONCLUSIVE DUE TO THE LACK OF INFO PROVIDED BY THE USER FACILITY.
THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER. THE IAB WAS NOT RETURNED TO CO. FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY.
THE NAIL BROKE THROUGH THE INNER PACKAGING. THIS EVENT WAS NOTICED PRIOR TO THE SURGICAL PROCEDURE AND DID NOT INVOLVE A PT.
SECTION F1-14 HAS BEEN COMPLETED BY THE MFR. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. SUMMARY OF EVALUATION: A VISUAL INSPECTION OF THE RETURNED PACKAGING VERIFIED THE REPORTED INCIDENT; THE BLISTER WAS CRACKED AS A RESULT OF THE DISTAL AND PROXIMAL ENDS OF THE IMPLANT BREAKING THROUGH THE BLISTER PACKAGE. THE DAMAGE TO THE BLISTER MOST LIKELY RESULTED FROM THE PRODUCT BEING SUBJECTED TO EXCESSIVE MOVEMENT DURING SHIPPING OR DROPPING THE PRODUCT ON ITS END. CORRECTIVE ACTION HAS BEEN IMPLEMENTED FOR THIS EVENT.
THE REPORTER RETURNED THE DEVICE AND INDICATED THAT THE SCREEN IS BLANKING. THERE WAS NO INDICATION THAT A PT WAS INVOLVED.
REFERESENCE SECTION F.10 OF THIS FORM OF THE EVENT PROBLEM CODES. THE MALFUNCTION WAS DUE TO A HARDWARE/SOFTWARE INTERFACE ANOMALY THAT OCCURS, WITH VERSION 1.02 SOFTWARE, WHEN THE UNIT IS TURNED OFF BY DISCONNECTING POWER AS OPPOSED TO USING THE POWER ON/OFF SWITCH.
AN IMPLANT FAILED DUE TO INFECTION AND BONE LOSS.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. HOWEVER IT WAS NOTED DURING INSPECTION THAT THE RETURNED PART IS PART NUMBER 0802, NOT 0801 AS ORIGINALLY REPORTED. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE MD.
THERE WAS MORE LEAKING THAN USUAL FROM THE CLEAR HEMOSTASIS VALVE. THE HEMOSTASIS VALVE WAS NOT TAKEN OFF THE INTRODUCER. THE HEMOSTASIS VALVE AND INTRODUCER WERE NOT RETURNED TO THE CO. FOR EVALUATION THEY WERE DISCARDED BY THE FACILITY.THE FOLLOWING WAS REPORTED TO CO. ON 9/17/96:UPON INSERTION OF THE SHEATH SUPPLIED WITH THE KIT AND REMOVAL OF THE DILATOR, A LARGE AMOUNT OF BLOOD WAS LEAKING FROM THE CLEAR HEMOSTASIS VALVE AT THE LUER-LOCK CONNECTION. THE CARDIOLOGIST NEEDED TO KEEP HIS FINGER OVER THE END OF THE SHEATH. BLEEDING IS COMMON BUT THIS WAS MORE THAN USUAL. THE PATIENT WAS EVENTUALLY WEANED FROM IABP AND THE IAB WAS REMOVED WITHOUT COMPLICATIONS.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO THE CO. FOR EVALUATION. THE ITEM WAS DISCARDED BY THE FACILITY.THIS FORM WAS PROPARED BY THE MANUFACTURER.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. INFECTION AND A HEAVY BITE WERE NOTED. THE PT WORE A FULL MAXILLARY DENTURE DURING THE HEALING PHASE. THIS IS THE SAME PT AS REPORTED IN MFR REPORT NUMBERS 202902199600043, 20290219960004, AND 2022902199600046.
THE DEVICE WAS USED DURING A GASTRO JEJUNOSTOMY PROCEDURE. THE TECHNICIAN CUT HIS THUMB WHEN HE WAS CHANGING THE DISPOSABLE LOADING UNIT. THE HOSP HAS NOT PROVIDED ANY FURTHER INFO.
11/8/1996 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
AT THE CONCLUSION OF A LAP CHOLY, IT WAS DISCOVERED THAT IN THE AREA BETWEEN THE TWO VERTICAL SLITS ON THE TIP OF THE CANNULA, 50% OF THE TIP WAS MISSING. THE PT WAS OPENED AND THE MISSING TIP PORTION WAS RETRIEVED. THEY DO NOT KNOW WHAT CAUSED THE BREAKAGE.
THE ACTUAL DEVICE WAS RETURNED TO CO AND VISUALLY EXAMINED ON 11/12/96. THERE WAS NO EVIDENCE OF A PRODUCT DEFECT.
THERE WAS MORE LEAKING THAN USUAL FROM THE CLEAR HEMOSTASIS VALVE. THE HEMOSTASIS VALVE WAS NOT TAKEN OFF THE INTRODUCER. THE HEMOSTASIS VALVE AND INTRODUCER WERE NOT RETURNED TO THE CO. FOR EVALUATION. THE ITEMS WERE DISCARDED BY THE FACILITY.
THE DEVICE WAS USED DURING A OPEN CHOLECYSTECTOMY PROCEDURE. THE CLIPS FELL FROM THE APPLICATION SITE INTRAOPERATIVELY. NO PT INJURY REPORTED.
11/15/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
A REPORT WAS RECEIVED OF A FIFTH ENDOSSEOUS DENTAL IMPLANT WHICH WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. INFECTION AND A HEAVY BITE WERE NOTED. THE PT WORE A FULL MAXILLARY DENTURE DURING THE HEALING PHASE. THIS IS THE SAME PT AS REPORTED IN MFR REPORT NUMBERS 2029012199600043, 2029012199600044, AND 2029012199600045.
A REVIEW OF DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE DOES NOT INDICATE THAT THIS HAS BEE A RECURRING CONDITION SINCE THIS MACHINE WAS RELEASED TO FIELD. A SECONDARY SEARCH OF DTF HISTORY FOR THIS PRODUCTION LOT IS NOT POSSIBLE WITHOUT RETURNED PART. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: AFFECTED COMPONENT, PRV-3, WAS REPLACED AND DISCARDED BY TECH, AFFTECTED COMPONENT WAS NOT RETURNED FOR EVAL AND WITHOUT AFFECTED COMPONENT, A THOROUGH EVAL CANNOT TAKE PLACE. ALTHOUGH COMPONENT WAS NOT RETURNED, SEVERAL CONCLUSIONS AS TO REPORTED INCIDENT CAN BE MADE FORM INFO FORWARDED FROM FACILITY. 1. AS REPORTED IN ATTACHED FAXES FROM FACILITY, DIAPHRAGM INSIDE OF PRV-3 WAS RED. CURRENT DIAPHRAGM IS OF A SANTOPRENE SUBSTANCE AND IS IVORY IN COLOR. THIS INDICATES THAT MACHINE HAS NOT RECIEVED AN ENTIRE OR CORRECT PREVENTIVE MAINTENANCE IN AT LEAST TWO YEARS, AS THAT IS TIME FRAME THAT NEW DIAPHRAGM HAS BEEN IN USE. NEW DIAPHRAGM WAS PUT INTO USE ON ECO#62860 IN 5/94. ALL SPARES KITS AND PM KITS SINCE THAT TIME PERIOD HAVE INCLUDED NEW DIAPHRAGMS FOR USE. IT HAD BEEN OBSERVED THAT RED DIAPHRAGMS WERE SUSCEPTIBLE TO DEGRADATION. USE OF SANTOPRENE DIAPHRAGM AND A REGULAR PM SCHEDULE TO CHANGE DIAPHRAGM IS DESIGNED TO PREVENT THIS TYPE OF PROBLEM. FACILITY COMMUNICATED THAT MACHINE WAS LEAKING. DUE TO DIFFICULTY IN COMMUNICATING WITH CUSTOMER, IT COULD NOT BE DETERMINED EXACTLY WHERE MACHINE WAS LEAKING FROM, BUT A LEAK FROM ULTRAFILTRATION SYSTEM IS CONSISTENT WITH EXCESS WEIGHT REMOVAL. IT HAS ALSO BEEN SEEN PREVIOUSLY THAT WHEN PRV-3 DIAPHRAGM DEGRADES, AN EXTERNAL LEAK DEVELOPS. SO IT CAN BE ASSUMED THAT LEAK WAS FROM ULTRAFILTRATION SYSTEM. TO HELP VERIFY ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED BEFORE FIRST TREATMENT DAY, IF MACHINE HAS BEEN TURNED OFF, IT A PT WEIGHT DISCREPANCY IS DISCOVERED, IF DIALYSATE TYPE IS CHANGED (BICARBONATE OR ACETATE), OR AFTER ANY  CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10)0 OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF CALCUALTED VALUE TO ACTUAL VALUE AFTER TREATMENT BEGINS. THIS VERIFIES THAT ULTRAFILTRATION RATE IS AS EXPECTED. FACILITY REPORTS THAT "OBLIGATORY TESTS WERE PERFORMED" PRIOR TO OPERATING MACHINE. THIS IS HIGHLY UNLIKELY, SINCE PT REPORTEDLY LOST 2 KG. OF FLUID, NOT PROGRAMMED 0.5 KG., IN A ONE HOUR TIME PERIOD. THIS REPRESENTS A SIGNIFICANT LEAK, WHICH WOULD BE DETECTED BY AUTOTEST FUNCTION. AGAIN, AS REPORTED BY FAX, FACILITY HAD NO MAINTENANCE CONTRACT FOR MACHINES WITH CO. THIS SUPPORTS ABOVE CONCLUSION THAT MACHINES HAD NOT RECIEVED PROPER PREVENTIVE MAINTENANCE SINCE INSTALLATION OF MANCINE, SINCE IT MOST LIKELY HAD ORIGINAL DIAPHRAGMS STILL IN IT AFTER TWO YEARS OF USE. SUGGESTED PREVENTIVE MAINTENANCE SCHEDULE IS 2000 HOURS OF OPERATION OR ONE YEAR. FOLLOW-UP ACTION: PART WAS NOT AVAILBLE FOR INVESTIGATION.
DURING A DIALYSIS TREATMENT, THERE WAS EXCESS WEIGHT REMOVAL REPORTED. THE MACHINE WAS PROGRAMMED TO REMOVE 2 KG. OF FLUID IN A FOUR HOUR TIME PERIOD. THE TREATMENT WAS STOPPED WHEN THE PT EXPERIENCED UNCONSCIOUSNESS AND AN ACUTE BLOOD PRESSURE DROP AFTER THE FIRST HOUR. PT WAS STABILIZED AND IS CURRENTLY REPORTED TO BE FINE. THE PT WAS WEIGHED AND IT WAS FOUND THAT 2 KG. OF FLUID HAD BEEN REMOVED DURING THE ONE HOUR OF TREATMENT. AN MES TECH SERVICED THE MACHINE AFTER THE INCIDENT AND REPLACED THE PRESSURE REGULATOR, PRV-3.
LEAD IMPEDANCE, VENTRICULAR MORE THAN 2,700 OHMS. ON X-RAY LEAD WIRES WERE TWISTED IN POCKET, POSSIBLE LEAD FRACTURES.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. PNEUMOPERITOMEMUM LEAKED FROM THE INSTRUMENT. THE SURGEON USED ANOTHER INSTRUMENT AND COMPLETED THE PROCEDURE WITHOUT INCIDENT.
11/08/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. INFECTION AND A HEAVY BITE WAS NOTED. THE PT WORE A FULL MAXILLARY DENTURE DURING THE HEALING PHASE. THIS IS THE SAME PT AS REPORTED IN MFR REPORT NUMBERS; 2029012199600043, 2029012199600045 AND 2029012199600046.
DORSAL COLUMN STIMULATOR IMPLANTED IN FEBRUARY QUIT WORKING. PT RETURNED TO OR FOR REMOVAL OF STIMULATOR AND IMPLANT OF NEW DEVICE. WIRES ON BOTH LEADS WERE BROKEN.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE ON THE SHOULDER. REPORTEDLY, THE NEEDLE TIP BROKE. THE SURGEON RETRIEVED THE BROKEN COMPONENT.
11/07/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. DUE TO A CLERICAL ERROR, THE STATUTORY REPORTING REQUIREMENT OF 30 CALENDAR DAYS WERE EXCEEDED.
DORSAL COLUMN STIMULATOR IMPLANTED IN FEBRUARY QUIT WORKING. PT RETURNED TO OR FOR REMOVAL OF STIMULATOR AND IMPLANT OF NEW DEVICE WIRES ON BOTH LEADS WERE CRACKED.
11/5/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE RESIDENT HAD A DIAGNOSIS OF ASPIRATION PNEUMONIA UPON ADMISSION TO THE FACILITY. ALL MEDS AND FEEDING WERE GIVEN THROUGH A J-TUBE. PT HAD BEEN RECEIVING AN ENTERAL FEEDING SOLUTION AT 60 CC/HR CONTINUOUSLY. AT 5:00 AM ON 10/12/96, THE NURSE STARTED THE FEEDING. AT 7:15AM, THE NURSE FOUND THE BAG EMPTY WITH THE PUMP ALARM SOUNDING. THE RESIDENT WAS LATER TRANSFERRED TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL FOR ASPIRATION. THE REPORTER STATED THE SOURCE OF THE EVENT WAS THE IMPROPER INSERTION OF THE ADMINISTRATION SET AROUND THE PUMP ROTOR. ONE PT INVOLVED.
CO'S STANDARD PROCEDURE INCLUDES SENDING A MEDWATCH FORM TO THE REPORTER FOR COMPLETION AND RETURN. IN THIS CASE, THE REPORTER DID NOT PROVIDE THE REQUIRED INFO FOR THE FOLLOWING SECTIONS: D10;F2,F9, AND F10.
PT RAN FROM ROOM TO NURSES STATION COMPLAINING OF CHEST PAIN. PT DIAPHORETIC, CRYING AND COUGHING. EVALUATED AND FOUND TO HAVE PULSE OXIMETRY READING OF 88% ON ROOM AIR. RESPIRATORY RATE 34(BASELINE 20'S). BLOWBY OXYGEN ADMINISTERED WITH IMPROVEMENT OF PULSE OXIMETRY TO 95-97%. PT WITH PERSISTING COMPLAINTS OF CHEST PAIN. PT EMPHATICALLY ASKING CARE PROVIDERS NOT TO USE LEFT HAND IV HEPLOCK AND STATING "SHE PUT SOMETHING IN IT." AIR NOTED IN T-CONNECTOR. BASED ON FURTHER QUESTIONING OF THE PT AND HER 5-YEAR OLD PLAYMATE, CUSTOMER BELIEVES THAT THE GIRLS ADMINISTERED A BOLUS (AMOUNT UNK, BUT ANOTHER CO'S SYRINGE WAS FOUND WITH PLAYMATE) OF AIR THROUGH THE DEVICE TO THE PT WHILE PLAYING. DEVICE WAS CONNECTED TO A SMALLBORE.
THIS REPORT IS BEING SUBMITTED ON THE BASIS THAT THE MFR, RECEIVED A MEDWATCH FORM FROM THE USER FACILITY.
THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT, DUE TO FLUID LOSS-RIGHT CYLINDER, AND REPLACED.
AN INDEPENDENT SERVICE AGENT HAS REPORTED THAT UNIT FOLDED WITH PT ON BOARD. PT SUSTAINED A BROKEN BONE.
RE H-3 (81, OTHER) UNIT EVALUATED BY AN INDEPENDENT SERVICE AGENT. THE PRELIMINARY INFO HE PROVIDED IS: "BASED ON THE FACT THAT THE AUXILIARY LOCK, SLIDES, AND LOCK PINS STILL FUNCTION PROPERLY, IT LOOKS AS IF IT MIGHT BE USER ERROR."
BALLOON PUMP HAD SYSTEM FAILURE. ALARM SOUNDED AND PUMP TURNED OFF. ROOM SMELLED OF SMOKE. PUMP DISCONTINUED PER PHYSICIAN ORDER.
THE DEVICE WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/07/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WAS A POOR FIT ON THE RIGHT SIDE. ANOTHER DEVICE WAS IMPLANTED. ADD'L LOT/SER NO: 6752P 002.
THE DEVICE WAS USED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY THE INSTRUMENT MISFIRED. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
HX AUGMENTATION 1980. DEVELOPED FIRM BREAST. IMPLANT WAS 180 CC. AUTO ACCIDENT 1984 WITH LOSS OF PROJECTION OF RIGHT BREAST. CLOSED CAPSULOTOMY ON LEFT FOR SYMMETRY. RUPTURE RIGHT IMPLANT.
THE RIGHT CYLINDER WAS REMOVED FROM THE PT, REASON NOT INDICATED, AND REPLACED. CO HAS REQUESTED ADD'L INFO.
DEVICE WAS IMPLANTED IN 6/91. REVISION SURGERY WAS PERFORMED ON 10/9/96, DUE TO INSTABILITY.
THERE ARE WARNINGS IN THE PACKAGING  INSERT THAT STATED THAT THIS TYPE OF EVENT CAN OCCUR. THIS TYPE OF EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICAITONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT. A FAX SENT TO THE USER FACILITY ON 10/29/96. CO RECEIVED A FAXED "VOLUNTARY" MEDWATCH REPORT FORM FROM THE USER FACILITY. THE USER FACILITY SENT ONLY THE SECOND PAGE OF THE MEDWATCYH REPORT.
THE DEVICE WAS USED DURING A LAPAROSCOPICALLY CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT LOAD PROPERLY AND THE JAWS SCISSORED. THE SURGEON REMOVED THE DEVICE WITHOUT INCIDENT.
7/16/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
DEVICE WAS IMPLANTED ON 7/2/86. THE CYLINDERS AND PUMP WERE REVISED ON 7/25/90. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 10/16/96, DUE TO FLUID LOSS, AND REPLACED. ADD'L LOT/SER NO: 8131K.
PT'S ATTORNEY REPORTED LEG LENGTH DISCREPANCY NECESSITATED REVISION OF IDENTIFIED ACETABULAR BEARING INSERT AND ANOTHER ORTHOPAEDIC MFR'S FEMORAL HIP STEM AND HEAD. REVISION SURGERY WAS REPORTED AS PERFORMED ON 11/10/94.
SUBMISSION OF INFO BY OSTEONICS UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CASUAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFO ACT. INFO CONCERNING THIS REPORT WAS ORIGINALLY RECEIVED FROM THE PT'S ATTORNEY. THE SUBJECT DEVICE WAS NOT MADE AVAILABLE FOR CO'S EVALUATION. BASED ON THIS, SEVERAL BLOCKS WITHIN SECTION F ARE NA-NOT AVAILABLE. IN THIS CASE, THE INSERT WHICH WAS REPORTEDLY REVISED WAS REPLACED WITH A SECOND INSERT. THE CENTER OF ARTICULATION OF BOTH INSERTS IS DESIGNED IN THE IDENTICAL LOCATION. THEREFORE, IT IS CONCLUDED THAT THE REVISED LINER DID NOT CAUSE OR CONTRIBUTE TO THE LEG LENGTH DISCREPANCY FOR WHICH THE PT UNDERWENT REVISION SURGERY. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE PACKAGE INSERT STATES, IN PERTINENT PART "BEFORE CLINICAL USE, THE SURGEON SHOULD THOROUGHLY UNDERSTAND ALL ASPECTS OF THE SURGICAL PROCEDURE AND LIMITATIONS OF THE DEVICE, APPROPRIATE SELECTION, PLACEMENT AND FIXATION OF THE FEMORAL STEM AND/OR ACETABULAR COMPONENTS ARE CRITICAL FACTORS WHICH AFFECT IMPLANT SERVICE LIFE. AS IN THE CASE OF ALL PROSTHETIC IMPLANTS, THE DURABILITY OF THESE COMPONENTS IS AFFECTED BY NUMEROUS BIOLOGICAL, BIOMECHANIC AND OTHER EXTRINSIC FACTORS, WHICH LIMIT THEIR SERVICE LIFE. ACCORDINGLY, STRICT ADHERENCE TO THE INDICATIONS, CONTRAINDICATES, PRECAUTIONS AND WARNINGS FOR THIS PRODUCT IS ESSENTIAL TO POTENTIALLY MAXIMIZE SERVICE LIFE." THE PACKAGE INSERT CONTINUES BY STATING, "CO STRONGLY ADVISES AGAINST THE USE OF ANOTHER MFR'S FEMORAL STEM COMPONENT WITH ANY OF CO'S ACETABULAR SYSTEM COMPONENT. ANY SUCH USE WILL NEGATE THE RESPONSIBILITY OF CO FOR THE PERFORMANCE OF THE RESULTING MIXED COMPONENT IMPLANT." FINALLY, "ADVERSE EFFECTS MAY NECESSITATE REOPERATION, REVISION, ARTHRODESIS OF THE INVOLVED JOINT, GIRDLESTONE AND/OR AMPUTATION OF THE LIMB."
THE DEVICE WAS REMOAVED FROM THE PT DUE TO INFECTION.
DURING A NEEDLE CORE BIOPSY, THE NEEDLE MOVED AND MISSED THE INTENDED TARGET. THIS MOVEMENT WAS CAUSED BY OPERATION OF A BIOPSY GUN WHICH CAUSED THE ASSEMBLY TO MOVE SLIGHTLY.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING? NO. IS SEVERITY OF OCCURRENCE OF EVENT ADDRESSED IN DEVICE LABELING? NO. IS SEVERITY GREATER FOR THIS EVENT THAN USUAL? UNK.
THE IPP DEVICE WAS REMOVED FROM THE PT DUE TO A FLUID LOSS AT TUBING OF LEFT CYLINDER.
CYLINDER WAS FUNCTIONAL. CYLINDER HAD A SEPARATION LEAK. TUBING HAD A WEAR LEAK. TUBING WAS FUNCITONAL.
THE DEVICE WAS USED DURING A BILLROTH II PROCEDURE. REPORTEDLY THE SURGEON REPORTED THE LOADING UNIT HAD NO STAPLES. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
ON 7/5/83 A DEVICE WAS IMPLANTED. ON 10/21/86 THE PUMP WAS REVISED. ON 12/13/88 THE DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED.
THE DISPOSABLE UNIT WAS USED WITH AN DISPOSABLE STAPLER DURING A LOBECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM. THE SURGEON RELOADED THE INSTRUMENT AND COMPLETED THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING ACQUISITION OF WB STUDY, THE CAMERA AFTER ADVANCING TO 2ND FRAME, RAISED HEAD 2 (BELOW TABLE), THE HEAD CONTACTED THE TABLE AND PROCEDED TO RAISE THE BED AND THE PT AROUND 4". AT THIS TIME THE TECH PRESSED THE EMERGENCY STOP WHICH DID STOP CAMERA MOTION. TECH INDICATES THAT THIS HAS OCCURRED TWICE OVER THE LAST FEW MONTHS AND THAT HE HAD DISABLED THE COLLIMATOR TOUCH PAD SENSORS BY PLACING "JUMPERS" IN THE CAMERA ARMS.
H3 81 SMV SVC TECH AND CO'S PROJECT MGR. TALKED WITH CHIEF TECHNOLOGIST ON SITE. H6 86. CO'S INVESTIGATED AND FOUND THAT SITE TECHNOLOGIST HAD BYPASSED A SAFETY SWITCH AND FAILED TO CALIBRATE TABLE PER CAMERA SET UP INSTRUCTIONS (P/N 98-090001).
PUMP PERFORRMED WITHIN SPECIFICATIONS. CYLINDER WAS FUNCTIONAL. CYLINDER HAD TORN FABRIC AND BULGING. TUBING WAS FUNCTIONAL.
ADDITIONAL INFORMATION RECEIVED ON 12/12/96 INDICATES THE REASON FOR REMOVAL WAS PENILE CURVATURE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS DID NOT FORM PROPERLY. NO PT INJURY REPORTED.
11/05/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
AN ABUTMENT SCREW FRACTURED INSIDE AN IMPLANT. SURGEON HAD TO PERFORM AN ADD'L SURGICAL PROCEDURE TO REMOVE THE ABUTMENT SCREW FROM THE IMPLANT.
THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION OF THE RIGID CORPORA. ADD'L LOT/SER NO: 4104P 005.
INFO RECEIVED ON 10/14/96 INDICATES POOR STABILITY AT THE BASE OF THE PENIS IN THE DEVICE. CO HAS REQUESTED ADD'L INFO.
ELECTRONIC TESTING OF THE RETURNED SENSOR WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPEC. NO PHYSICIAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPEC. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT WITHIN SPEC.
ON 3/12/96 DEVICE WAS IMPLANTED. ON 7/19/96 THE PUMP WAS REMOVED FROM THE PT. ON 10/15/96 THE CYLINDERS AND RESERVOIR WERE REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO INFECTION.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO AN INFECTED PUMP. ADD;L LOT/SER # CC012 012.
TUBING HAD OR DAMAGE. PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDERS PERFORMED WITHIN SPECIFICATIONS.
DEVICE WAS REMOVED FROM THE PT, DUE TO INFECTION AT BOTH CYLINDERS, AND REPLACED.
ON 4/3/89 DEVICE WAS IMPLANTED. ON 10/19/89 THE CYLINDERS WERE REVISED. ON 3/19/96 THE PUMP WAS REVISED. ON 7/24/96 THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO RUPTURE.
PT WAS PRESENTED TO SURGEON WITH HIP DISCOMFORT. RADIOGRAPHIC EVALUATION SUGGESTED LOOSENED ACETABULAR SHELL. A REVISION SURGERY WAS PERFORMED TO SURGICALLY REPLACE ACETABULAR SHELL, MODULAR BEARING INSERT AND FEMORAL HEAD.
SUBMISSION OF INFO BY OSTEONICS UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRES TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CASUAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFO ACT. THE ORIGIN OF THIS REPORT WAS FROM AN CO'S CLINICIAN NOT A USER FACILITY OR DISTRIBUTOR. BASED ON THIS, SEVERAL BLOCKS WITHIN SECTION F ARE NA-NOT AVAILABLE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS STATED IN THE PACKAGE INSERT. THE PACKAGE INSERT STATES, IN PERTINENT PART "LOOSENING OF TOTAL HIP COMPONENTS CAN OCCUR. EARLY MECHANICAL LOOSENING MAY RESULT FROM INADEQUATE INITIAL FIXATION, LATENT INFECTION, PREMATURE LOADING OF THE PROSTHESIS OR TRAUMA. LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATIONS OR MECHANINCAL PROBLEMS, WITH THE SUBSEQUENT POSSIBILITY OF BONE EROSION AND/OR PAIN." THE PACKAGE INSERT CONTINUES BY STATING, "ADVERSE EFFECTS MAY NECESSITATE REOPERATION, REVISION, ARTHRODESIS OF THE INVOLVED JOINT, GIRDLESTONE AND/OR AMPUTATION OF THE LIMB."
THE DEVICE WAS USED DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT OPEN INSIDE THE CAVITY. THE SURGEON REMOVED THE DEVICE AND APPLIED ANOTHER ONE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/7/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
ON 2/29/92 DEVICE WAS IMPLANTED. ON 3/1/94 THE LEFT CYLINDER WAS REVISED. ON 10/17/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS.  ANOTHER DEVICE WAS IMPLANTED.
EMT'S RESPONDED TO A PERSONDESCRIBED AS IN FULL CARDIAC ARREST. THE DEVICE WAS CONNECTED TO THE PT WITH DISPOSABLE DEFIBRILLATION/ECG ELECTRODES AND POWERED UP. ACCORDING TO THE REPORTER, THE DEVICE ALARMED "CONNECT ELECTRODES" AND WOULD NOT ANALYZE THE PT'S RHYTHM. USE OF THE DEVICE WAS DISCONTINUED AND STANDARD ACLS PROTOCOL FOLLOWED. THE PT WAS NOT RESUSCITATED. THE REPORTER INDICATED THE REPORTED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PT. THE REPORTER BASED THEIR OPINION ON THE ATTENDING PARAMEDIC'S ASSESSMENT OF THE PT'S VIABILITY.
IN AN EVAL OF DEVICE BY LOCAL CO SERVICE REP, A COMPLETE FUNCTIONAL TEST WAS PERFORMED AND PROPER OPERATION WAS OBSERVED.
DEVICE WAS REMOVED FROM THE PT DUE TO PAIN-UNABLE TO OPERATE PROSTHESIS.
IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. A HEAVY BITE, CLENCHING, BRUXISM, PURULENT DRAINAGE AND BONE LOSS WERE NOTED.
86=DIMENSIONAL ANALYSIS; 100=THE RETURNED COMPONENT MET CO VISUAL AND DIMENSIONAL SPECIFICATIONS IN ALL RESPECTS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
IMPLANT WAS EXPLANTED DUE TO A LOSS OF OSTEOINTEGRATION. A HEAVY BITE, CLENCHING, BRUXISM, PURULENT DRAINAGE AND BONE LOSS WERE NOTED.
86=DIMENSIONAL ANALYSIS; 100=VISUAL EXAMINATION SHOWED BONE TISSUE MATTER IN THE BASKET AREA OF THE IMPLANT, THEREFORE, A COMPLETE DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED. THE RETURNED COMPONENT MET THE REMAINING CO DIMENSIONAL SPECIFICATIONS.
ADITIONAL INFORMATION RECEIVED ON 11/18/96 INDICATES THE DEVICE WAS REMOVED DUE TO FLUID LOSS-CYLINDER.
THE CYLINDERS WERE REMOVED FROM THE PT, DUE TO PENILE ANGULATION, AND REPLACED.
INFO RECEIVED INDICATES A MALLEABLE DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED, AND REPLACED. CO HAS REQUESTED ADD'L INFO.
THE IPP DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS, AND REPLACED. ADD'L LOT/SER NO: AP930 007.
THE CUSTOMER COMPLAINS OF INTERMITTENT IMPEDANCE PROBLEMS WHEN USING THIS DEVICE. NO SPECIFIC INCIDENT DETAILS WERE PROVIDED BY THE REPORTER.
CO'S FIELD SVC HAS TESTED THE UNIT AND FOUND IT TO OPERATE NORMALLY DURING PERFORMANCE AND FUNCTIONAL TESTING. THE FACILITY REQUESTED A FACTORY ANALYSIS BE PERFORMED. CO ANALYZED THE UNIT AND FOUND IT TO OPERATE NORMALLY DURING PERFORMANCE AND FUNCTIONAL TESTING. DURING REPETITIVE TESTING, CONNECTOR J1 ON THE PRINTED FLEX CIRCUIT WAS OBSERVED LOOSE AND TO CAUSE AN INTERMITTENT LEADS OFF FAILURE WHEN MODERATE PHYSICAL STRESS WAS APPLIED. FAILURE ANALYSIS AND REPAIR ESTIMATE DETAILS WERE DISCUSSED WITH THE CUSTOMER. TO DATE IT IS UNCERTAIN IF THE CUSTOMER WILL AUTHORIZE REPAIRS OR RETIRE THE UNIT.
THE DISPOSABLE LOADING UNIT WAS USED WITH A STAPLER DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE KNIFE DID NOT CUT. WHILE UNLOADING THE DISPOSABLE LOADING UNIT, THE KNIFE BLADE DISENGAGED. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO EROSION AND FLUID LOSS.
86=DIMENSIONAL ANALYSIS. 100=VISUAL EXAMINATION SHOWED BONE TISSUE MATTER IN THE BASKET AREA OF THE IMPLANT, THEREFORE, A COMPLETE DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED. THE RETURNED COMPONENT MET THE REMAINING CO DIMENSIONAL SPECIFICATIONS.
AN IPP DEVICE WAS IMPLANTED IN 1991, DAY AND MONTH NOT INDICATED. INFO RECEIVED ON 10/14/96 INDICATES THE PT IS TO HAVE A REVISION SURGERY ON 10/16/96, REASON NOT INDICATED.
A REVISION SURGERY IS PLANNED FOR 10/16/96. NO FURTHER INFO RECEIVED.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT DUE TO EROSION.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED, REASON NOT INDICATED.
DEVICE WAS REMOVED FROM HE PT DUE TO INFECTION. A MALLEABLE DEVICE WAS IMPLANTED. ADD'L LOT/SER NO: 4171L 016.
A REPORT WAS RECEIVED OF AN ENDOSSEOUS DENTAL IMPLANT WHICH WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATION. INFECTION AND A HEAVY BITE WERE NOTED. THE PT WORE A FULL MAXILLARY DENTURE DURING THE HEALING PHASE. THIS IS THE SAME PT AS REPORTED IN MFR REPORT NUMBERS: 2029012199600044,2029012199600045 AND 2029012199600046.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED BECAUSE THE RIGHT CYLINDER BURST, POSSIBLY BUCKLED. ADDL LOT/SER NO: 9234P 015.
THE DEVICE WAS USED DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE KNIFE DID NOT CUT. WHILE UNLOADING THE DISPOSABLE LOADING UNIT, THE KNIFE BLADE DISENGAGED. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DEVICE WAS REMOVED FROM THE PT, DUE TO A FLUID LOSS-TUBING BETWEEN RT     CYLINDER AND PUMP, AND REPLACED.
PUMP PERFORMNED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A WEAR LEAK. TUBING HAD A FATIGUED ANDS WEAR LEAK.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. ADD'L LOT/SER NO: 4279P 007.
THE DEVICE WAS USED DURING AN UNSPECIFIED THORACIC PROCEDURE. THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED SUTURE TO COMPLETE THE PROCEDURE. THE HSOP HAS REPORTED THAT NO PT INJURY OCCURRED.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD A FATIGUE LEAK. CYLINDER HAD A FATIGUE LEAK.
DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED, AND REPLACED. CO HAS REQUESTED ADD'L INFO. ADD'L LOT/SER NO: 0462M 003.
THE DEVICE WAS REMOVED FROM THE PT DUE TO PUMP MALFUNCITON-WOULD NOT INFLATE. ADD'L LOT/SER NO: CF958 011.
THE DEVICE WAS USED DURING AN ESOPHAGECTOMY GASTRITUBE PROCEDURE. REPORTEDLY, THE INSTRUMENT EJECTED CLIPS PREMATURELY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. AN IPP DEVICE WAS IMPLANTED. CO HAS REQUESTED ADD'L INFO.
THE PT WAS UNDERGOING A TOTAL ABDOMINAL HYSTERECTOMY/BILATERAL SALPINGOOPHERECTOMY AND APPENDECTOMY. REPORTEDLY, THE TIP OF THE NEEDLE BROKE OFF. THE SURGEON WAS UNABLE TO RETRIEVE THE COMPONENT.
11/12/96 - SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER#: CD020 002.
THE CYLINDERSS AND PUMP WERE REMOVED FROM TNE PT AND REPLACED DUE TO INFECTION.
PUMP PERFORMED WITHIN SPECIFICATINS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CONNECTOR WAS FUNCTIONAL.
DEVICE WAS REMOVED FROM THE PT, DUE TO A PUMP MIGRATION, SCROTAL PAIN, AND PT DISSATISFACTION, AND REPLACED. ADD'L LOT/SER NO: BT247 005.
THE DEVICE WAS USED DURING A LAPAROSCOPIC PROCEDURE. REPORTEDLY, THE LENS WAS BROKEN. THE SURGEON USED ANOTHER INSTRUMENT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE RESERVOIR WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -RESERVOIR, HOLE IN TOP.
ON 8/13/96, AN IPP DEVICE WAS IMPLANTED. ON 10/14/96, THE DR REPORTED "POOR STABILITY AT THE BASE OF THE PENIS." ADD'L LOT/SER#: CC789 021.
ON 10/15/96 IT WAS REPORTED PT IS EXPERIENCING SPONTANEOUS INFLATION.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO ANEURYSM.
THE REPORTER INDIACTED THAT THE PROGRAMMER LOCKED AND INTERMITTENTLY BOOTS UP. THERE WAS NO INDIACTION THAT A PT WAS INVOLVED.
REFERENCE SECTION F.10 OF THIS FOR EVENT PROBLEM CODES. THE MALFUNCTION WAS DUE TO A SOFTWARE/HARDWARE INTERFACE ANOMALY THAT OCCURS, WITH VERSION 1/02 SOFTWARE, WHEN THE UNIT IS TURNED OFF BY DISCONNECTING POWER AS OPPOSED TO USING THE POWER ON/OFF SWITCH.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WAS "NON-FUNCTIONING". ANOTHER DEVICE WAS IMPLANTED.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS. A MALLEABLE DEVICE WAS IMPLANTED.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. THE SURGEON EXPERIENCED DIFFICULTY IN CLOSING AND FIRING THE INSTRUMENT. SUBSEQUENTL, THE STAPLES DID NOT FORM PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
TIP OF DEVICE WAS REPORTED BROKEN DURING SCREW INSERTION.
NO PT INJURY WAS REPORTED. CO DISCLAIMER: "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH AND NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW OR ITS EMPLOYEES, THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT".
VENTILATOR FOUND AUTO-CYCLING WITH INTUBATED PT'S OXYGEN SATURATION LEVEL DECREASING. RESPIRATORY ASSISTANCE VIA BAG MASK INITIATED WITH POOR RESULTS. ENDOTRACHEAL TUBE DISCOVERED OBSTRUCTED WITH MUCOUS PLUG. PT EXTUBATED AND RE-INTUBATED IN CONJUNCTION WITH OTHER, UNSUCCESSFUL RESUSCITATIVE EFFORTS.
THE PT WAS UNDERGOING RE-EXCISION OF A BASAL CELL CARCINOMA OF THE NOSE. WITH THE PT IN THE SUPINE POSITION UNDER INTRAVENOUS SEDATION AND LOCAL ANESTHESIA, THE PT'S FACE WAS PREPPED WITH PHISOHEX AND DRAPED IN A STERILE FASHION. THE OXYGEN CANNULA WAS PLACED IN THE MOUTH, SINCE THE TUMOR WAS NEAR THE NOSTRILS. XYLOCAINE, 1%, WITH EPINEPHRINE WAS INFILTRATED IN THE AREA AND THEN SURGICAL INCISIONS WERE MADE ALONG THE LATERAL MARGINS OF THE PREVIOUSLY RESECTED NOSE ON THE RIGHT, LEFT AND SUPERIOR THREE PIECES THAT WERE SENT FOR SAMPLING. THEREAFTER, A DISSECTION PLANE WAS CARRIED ALONG AT THE LEVEL OF THE NASAL CARTILAGES AND LOW LATERAL CARTILAGES WERE REMOVED PARTIALLY FROM THE SUPERIOR PART FROM WHERE THE BASAL CELL HAD BEEN PREVIOUSLY RESECTED. ONCE THIS WAS ACCOMPLISHED, THERE WAS A SIGNIFICANT AMOUNT OF BLEEDING DUE TO THE PREVIOUS INFLAMMATION. MOST OF THE BLEEDING HAD SUBSIDED; THE SURGEON WAS THEN STOPPING THE BLEEDING ON THE SUPERIOR PART OF THE NASAL SIDE, THEN THERE WAS A FLASH FIRE FROM THE OXYGEN CANNULA. AT THAT POINT, THE SURGEON RAPIDLY GRABBED THE O2 CANNULA IN HIS GLOVED HAND WITH THE DRAPES AND THREW THE FLAMING DRAPES ONTO THE FLOOR WHERE THEY CONTINUED TO BURN. THE SCRUB NURSE IN THE OPERATING ROOM IMMEDIATELY POURED WATER ONTO THE PT'S BURN. AT THAT POINT, THE SURGEON GRABBED THE PT, HELD HER IN HIS ARMS FOR A FEW MINUTES, AND TOLD HER THAT EVERYTHING WAS OKAY. ONCE THIS WAS ACCOMPLISHED, THE SURGEON DEBRIDED THE SECOND DEGREE BURN WHICH WAS LOCALIZED OVER THE SUPERIOR PART OF THE UPPER LIP, THE LOWER LIP AND RIGHT CHEEK. THE PT'S MEDIAL PART OF HER EYELASHES WERE BURNED ON THE RIGHT SIDE AS WELL. HER TONGUE HAD CHAR ON IT, WHICH WAS DEBRIDED WITH A RAYTEC SPONGE. THEREAFTER, ICE WAS APPLIED TO THE WOUNDS FOR APPROXIMATELY SEVEN MINUTES. NEXT, NEOSPORIN WAS APPLIED TO THE BURN SITE. SILVADENE ON XEROFORM WAS APPLIED TO THE NOSE AND THIS WAS COVERED WITH TAPE. THE PT WAS THEN DISCHARGED TO THE RECOVERY ROOM IN STABLE CONDITION.S
AN IPP DEVICE WAS IMPLANTED ON 9/25/91. THE PUMP WAS REMOVED ON 8/4/95. THE PUMP WAS REIMPLANTED ON 2/16/96. THE PUMP WAS REMOVED ON 6/24/96. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 9/25/96 DUE TO SCROTAL INFECTION.
CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. TUBING HAD OR DAMAGE.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS -LEFT CYLINDER.
DEVICE IMPLANTED ON 7/25/96 AND PREDISCHARGE WAS ON 7/29/96. DURING PREDISCHARGE, INAPPROPRIATE NOISE EVENTS WERE DETECTED DURING THE REDECTION OF THE ARRHYTHMIA. THE STORED ELECTROGRAM SHOWED 2 OF THE 4 NOISE INTERVALS FOUND IN THE INTERVAL TABLE. THIS IS A CUSTOM DEVICE.
REFERENCE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE BEHAVIOR OBSERVED WAS DUPLICATED. HIGH FREQUENCY FIBRILLATION COULD BE SENSED AS NOISE, CAUSING PROLONGED FILBRILLATION DETECTION. A CHANGE TO THE NOISE DETECTION ALGORITHM HAS IMPROVED THIS BEHAVIOR.
DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS-CYLINDER, AND REPLACED.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED BECAUSE IT HAD COLLAPSED.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER WAS FUNCTIONAL. CYLINDER WAS FUNCTIONAL. TUBING WAS FUNCTIONAL.
FLUID WAS ADDED TO THE DEVICE, NO MALFUNCTION WAS FOUND.
DEVICE WAS IMPLANTED ON 7/21/86. THE CYLINDERS WERE REVISED ON 11/26/90. THE LEFT CYLINDER WAS REMOVED FROM THE PT ON 9/27/96 DUE TO FLUID LOSS AND INFECTION.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED BECAUSE THE DEVICE QUIT WORKING, THE RIGHT CYLINDER STOPPED WORKING ABOUT FIVE YEARS AGO AND THE LEFT CYLINDER ABOUT TWO YRS AGO.
CYLINDER HAD A WEAR LEAK. CYLINDER HAD A FATIGUE LEAK.
A PENILE PROSTHESIS WAS IMPLANTED SOMETIME IN 1982, DAY, MONTH AND PRODUCT TYPE NOT INDICATED. ON 8/20/96 THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
THE CUSTOMER SENT A MEDWATCH REPORT THAT STATED "THE PT WAS UNDER GOING RE-EXCISION OF A BASAL CELL CARCINOMA OF THE NOSE. A FLASH FIRE OCCURRED FROM THE OXYGEN CANNULA. AT THAT POINT, THE SURGEON GRABBED THE O2 CANNULA IN HIS GLOVED HAND W/THE DRAPES & THREW THE FLAMING DRAPES ONTO THE FLOOR WHERE THEY ACONTINUED TO BURN. THE SCRUB NURSE IN THE O.R. IMMEDIATELY POURED WATER ONTO THE PT'S BURN. THE SURGEON DEBRIDED THE 2ND DEGREE BURN WHICH WAS LOCALIZED OVER TE SUPERIOR PART OF THE UPPER LIP, LOWER LIP AND RIGHT CHEEK. THE PT'S MEDIAL PART OF HER EYELASHES WERE BURNED ON THE RIGHT SIDE AS WELL. HER TONGUE HAD CHAR ON IT, WHICH WAS DEBRIDED WITH A RAYTECH SPONGE".
THE CUSTOMER WAS CONTACTED AND THE GENERATOR WAS TESTED AT THE HOSPITAL AND FOUND TO FUNCTION PROPERLY AND RETURNED TO USE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY. CONFIDENTIAL TRADE SECRET INFO SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PRIVILEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO MALFUNCTION -15 YEARS SINCE IMPLANT.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVIUR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CYLINDER HAD A FATIGUE LEAK. TUBING WAS FUNCTIONAL.
THE RESERVOIR WAS REMOVED FROM THE PT, DUE TO FLUID LOSS, AND REPLACED.
X-TUBE ASSM 17" X 16". DEALER CLAIMS X-TUBE BROKE AT CENTERBOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFOMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE PUMP AND RESERVOIR WERE REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACTION - PT HAVING DIFFICULTY INFLATING AND DEFLATING DEVICE DUE TO LOCATION OF PUMP.
THE IPP DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS. ANOTHER DEVICE WAS IMPLANTED. ADD'L LOT/SER#: 5566H 008.
DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER NO: CD921 007.
INFO RECEIVED ON 10/18/96 INDICATES A REVISION SURGERUY OCCURRED ON 4/4/96. IT IS UNCERTAIN WHICH, IF ANY, COMPONENTS WERE REVISED DUE TO EROSION. CO HAS REQUESTED ADD'L INFO. ADD'L LOT/SER NO: AH648 005.
THE CYLINDERS WERE REMOVED FROM THE PT AND REPLACED DUE TO PT DISSATISFACITON - PENILE CURVATURE AND PAIN AT GLANS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN PROCEDURE. THE SAFETY SHIELD DID NOT RETRACT PROPERLY. THE SURGEON USED ANOTHER DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/6/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
X-TUBE ASSM 16" X 15". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. IT EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION. AN IPP DEVICE WAS IMPLANTED.
THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT, DUE TO A CROSSOVER OF RIGHT CYLINDER TO LEFT AND INADEQUATE RIGIDITY-BUCKLING, AND REPLACED.
THE CYLINDERS WERE REMOVED FROM THE PT, DUE TO FLUID LOSS-TUBING TO LEFT CYLINDER, AND REPLACED.
ON 1/27/87 A MALLEABLE DEVICE WAS IMPLANTED. ON 8/13/90 THE LEFT CYLINDER WAS REMOVED FROM THE PT. ON 10/15/96 THE RIGHT MALLEABLE CYLINDER WAS REMOVED FROM THE PT AND AN IPP DEVICE IMPLANTED DUE TO HEMATOMA AND SWELLING.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
ON 2/26/96 AN IPP DEVICE WAS IMPLANTED. ON 5/2/96 THE CYLINDERS AND PUMP WERE REVISED. ON 10/8/96 THE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO LEAKING. ADD'L LOT/SER # BW733 002.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDERS HAD OR DAMAGE.
DEVICE WAS IMPLANTED ON 1/15/85. THE CYLINDERS WERE REVISED ON 8/23/85. THE PUMP AND RESERVOIR WERE REVISED ON 9/30/86. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 10/1/96, DUE TO "NON-FUNCTIONING" AND REPLACED.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT, DUE TO INFECTION, AND REPLACED.
X-TUBE ASSM 17" X 16". DEALER CLAIMS X-TUBE BROKE OFF AT LEFT TOP SIDE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC, UNDER CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
ONE DEVICE AND TWO SUTURES WERE REPORTED TO HAVE BROKEN IN A MENISCAL REPAIR SURGERY.
PRODUCT WAS RETURNED FOR EVAL BUT NO CONCLUSION AS TO CAUSE COULD BE MADE. NO OTHER COMPLAINTS ON THESE LOTS HAVE BEEN REPORTED. NO PT INJURY WAS REPORTED. NO PT INJURY WAS REPORTED. CO DISCLAIMER: "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH AND NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH AND NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH AND NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT".
THE DEVICE WAS REMOVED FROM THE PT DUE TO AN ABSCESS.
THE IPP DEVICE WAS REMOVED FROM THE PT AND A MALLEABLE DEVICE IMPLANTED BECAUSE IT HAD "FAILED." ADD'L LOT/SER # 6660K 005.
PUMP PERFORMED WITHIN SPECS. RESERVOIR PERFORMED WITHIN SPECS. CYLINDER HAD OR DAMAGE. CYLINDER HAD A WEAR LEAK. CONNECTOR WAS FUNCTIONAL.
AN IPP DEVICE WAS IMPLANTED ON 11/2/92. THE LEFT CYLINDER WAS REMOVED FROM THE PT ON 6/29/96. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 10/11/96, DUE TO INFECTION, AND REPLACED.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING.
THE DEVICE WAS USED DURING AN EXPLORATORY LAPAROSCOPIC PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT UPON INSERTION. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE MALLEABLE DEVICE WAS REMOVED FROM THE PT AND AN IPP DEVICE IMPLANTED DUE TO PT DISSATISFACTION--MALPOSITION.
THE IPP DEVICE WAS REMOVED FROM THE PT BECAUSE OF DIFFICULTY USING THE DEVICE. A MALLEABLE DEVICE WAS IMPLANTED. ADD'L LOT/SER # BX338 003.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO PT DISSATISFACTION-NO RIGIDITY OF THE GLANS PENIS. THE RIGHT CYLINDER NOT IMPLANTED AFTER INITIAL PERFORATION. ADD'L LOT/SER#: 9220T 009.
THE AUS DEVICE WAS REMOVED FROM THE PT DUE TO URETHRAL DISRUPTION-EROSION.
PUMP PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS.
DEVICE WAS REPORTED TO PULL OUT OF LABRUM 3 MONTHS POST OPERATIVELY.
INVESTIGATION REVEALED THAT PT VIOLATED THE REHABILITATION PROGRAM BY WEIGHT LIFTING 3 MONTHS POST OPERATIVELY, RESULTING IN DEVICE PULL OUT. NO OTHER INFO IS AVAILABLE. CO DISCLAIMER: "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, TH EMEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE SMITH AND NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES  THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH AND NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT".
THE DEVICE WAS USED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. STAPLES WERE NOT PRESENT IN THE DEVICE. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
12/17/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN F9.
THE AUS DEVICE WAS REMOVED FROM THE PT, DUE TO FLUID LOSS, AND REPLACED.
CUFF HAD A WEAR LEAK. PUMP RESISTOR WAS CONTAMINATED.
THE POLYETHYLENE BEARING INSERT COMPONENT OF THE TOTAL KNEE TIBIAL PROSTHESIS BROKE. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES OT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES. D.6. MANUFACTURING LOT NUMBER WAS NOT PROVIDED. H.4. MANUFACTURE DATE IS UNK BECAUSE THE LOT NUMBER WAS NOT PROVIDED TO CO.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO AUTO INFLATION.
X-TUBE ASSM 16" X 16". DEALER CLAIMS X-TUBE BROKE AT THE WELD.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE REPORT.
THE IPP DEVICE WAS REMOVED FROM THE PT, DUE TO A FLUID LOSS-RESERVOIR, AND REPLACED. ADD'L LOT/SER # 1615Q 002.
ADDITIONAL INFORMATION RECEIVED ON 10/25/96 INDICATES THE REASON FOR REMOVAL WAS PUMP FAILURE OR BLOCKAGE.
DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE IMPLANTED DUE TO PAIN, PT DISSATISFACTION AND MALFUNCTION.
DEVICE WAS RETURNED DISASSEMBLED FROM HANDLE.
INVESTIGATION REVEALED SHAFT HAD BROKEN AT SET SCREW. DEVICE IS 7 YEARS OLD AND SHOWED SIGMS OF CORROSION AT SET SCREW. BROKEN PIECE WAS RETRIEVED. NO PT INJURY WAS REPORTED. CO DISCLAIMER: "SMITH & NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH AND NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT".
THE BALLOON WAS REMOVED FROM THE PT, DUE TO INADEQUATE BALLOON PRESSURE, AND REPLACED.
AN AUS DEVICE WAS IMPLANTED ON 12/5/90. THE BALLOON WAS REVISED ON 6/11/92. THE CUFF WAS REVISED ON 10/7/92. THE BALLOON AND PUMP WERE REMOVED FROM THE PT ON 10/8/96, DUE TO RECURRING INCONTINENCE, AND REPLACED.
PUMP WAS NOT FUNCTIONALLY TESTED. BALLOON ORIGINAL PRESSURE UNDETERMINEABLE.
THE DEVICE WAS USED DURING AN UNSPECIFIED GYNECOLOGICAL PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT DURING PENETRATION. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/05/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. CORRECTED DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
THE DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. CO HAS REQUESTED ADD'L INFO.
PUMP PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFROMD WITHIN SPECIFICATIONS. CUFF HAD A WEAR LEAK.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS. ADD'L LOT/SER#: 1306J 002.
PUMP PERFORMED WITHIN SPECIFICATIONS. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. CYLINDER HAD OR DAMAGE. TUBING WAS FUNCTIONAL.
DEVICE WAS IMPLANTED IN 9/93. REVISION SURGERY WAS PERFORMED ON 10/9/96, DUE TO INSTABILITY AFTER PT FELL.
THERE ARE WARNINGS IN THE PACKAGING INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS TYPE OF EVENT IS NOT OCCURRING A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION AS TO THE CAUSE OF THE EVENT. A FAX WAS SENT TO THE USER-FACILITY ON 10/29/96. CO RECEIVED A FAXED MEDWATCH "VOLUNTARY" REPORT FORM FROM THE USER FACILITY ON 11/14/96. THE USER FACILITY PROVIDED ONLY THE SECOND PAGE OF THE MEDWATCH FORM. THE FOLLOWING ADDITIONAL USER FACILITY INFORMATION IS AVAILABLE. CORRECTION MADE BECAUSE THE WRONG LOT # WAS GIVEN ON THE FIRST MEDWATCH REPORT THAT WAS SENT TO YOU ON 11/15/96.
CO DISCLAIMER: "SMITH AND NEPHEW ENDOSCOPY IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFO OBTAINED BY SMITH & NEPHEW WHICH THE CO MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH AND NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH AND NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH AND NEPHEW, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT".
IN EVAL OF THE DEVICE BY THE LOCAL SERVICE REP, A COMPLETE FUNCTIONAL TEST WAS PERFORMED AND PROPER OPERATION WAS OBSERVED. THE UNIT WAS RETURNED TO FACILITY FOR USE.
THE PUMP WAS REMOVED FROM THE PT, DUE TO FLUID LOSS AT TUBING-SPLIT, AND REPLACED.
XUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PRESSURE NOT WITHIN SPECIFICATIONS.
QR AXLE W/NUT. DEALER CLAIMS AXLES BROKE.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC, UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. IT EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR  THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING A ROUTINE PHACOEMULSIFICATION PROCEDURES THE DR REPORTED OBSERVING A CORNEAL BURN. THE DR STATED THAT THE ASPIRATION STOPPED DURING THE CASE. THE TUBING AND THE HANDPIECE WERE USED ON PRIOR CASES WITHOUT INCIDENT.
INFO IN BLOCK F WAS COMPLETED BY THE MFR. H6. 137, 48 - HANDPIECE WAS TESTED IN CONJUNCTION WITH THE MACHINE AND FOUND TO HAVE A WEAK CABLE. THE CABLE ISSUE WOULD NOT CONTRIBUTE TO THE EVENT. MECHANICAL AND FUNCTIONAL TESTS WERE PERFORMED ON THE MACHINE AND HANDPIECE. THE MACHINE WAS FOUND TO BE FUNCTIONING PROPERLY. THE HANDPIECE EXHIBITED AN INTERMITTENT CONNECTION IN THE CABLE WHICH RESULTED IN AN ERROR MESSAGE ON THE MACHINE. AN INTERMITTENT CONNECTION DOES NOT RELATE TO THE EVENT.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO PT REQUEST. ADD'L LOT/SER#: 7513P 004.
PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE. RESERVOIR HAD OR DAMAGE. TUBING HAD OR DAMAGE.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/8/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
ON 8/31/88 AN AUS DEVICE WAS IMPLANTED. ON 12/15/92 AND 7/11/94 THE BALLOON WAS REVISED. ON 11/22/94 FLUID WAS ADDED TO THE DEVICE. ON 6/20/96 THE BALLOON WAS REVISED. ON 10/9/96 THE CUFF AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO EROSION-CUFF.
8 X 2 FORK/STEM ASSM PWR THICK. DEALER CLAIMS: END USER BRUSHED UP AGAINST THE CURB AND THE FORK STEM SHEARED RIGHT OFF.
EVALUTION STARTING. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC., ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE CUFF WAS REMOVED FROM THE PT DUE TO CUFF EROSION -URETHRA.
BUR WAS REC'D WITH HEAD SHEARED OFF. MICROSCOPIC EXAMINATION REVEALED NO SOLDER DEFECTS OR OTHER EVIDENCE OF DAMAGE TO BUR. THIS FAILURE IS MOST OFTEN THE RESULT OF THE BUR CONTACTING A METALLIC SURGICAL INSTRUMENT SUCH AS A SUCTION TIP OR RETRACTOR, HOWEVER, THE CONDITION CAN NOT BE DUPLICATED. A MORE DEFINITIVE CONCLUSION CANNOT BE DRAWN. NOTE: INFO IN SECTIONS A,B,D,E AND F WERE NOT PROVIDED INITIALLY BY THE USER FACILITY AND MFR IS PROVIDING IT BASED ON CASE INVESTIGATION. ANY INFO NOT PROVIDED IS UNK OR UNAVAILABLE TO THE USER FACILITY. DISCLAIMER: SUBMISSION OF INFO BY STRYKER UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFO IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED. SUBMISSION OF THIS INFO IS NOT AN ADMISSION OF THE ACCURACY OF THE INFO CONTAINED WITHIN THE REPORT, WHICH WAS PROVIDED ORIGINALLY TO THE SUBMITTER BY OUTSIDE SOURCES. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFO OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFO ACT.
THE PT, A 7 Y/O IDDM, FELT FINE ON 10/16. HE TOOK HIS NORMAL DOSE OF MORNING INSULIN DESPITE HAVING OBTAINED A FASTING READING ON HIS METER OF 32 MG/DL. THROUGHOUT THE DAY, METER READINGS CONTINUED TO BE "LOW" AND, UPON ADVICE OF HIS PHYSICIAN, HIS INSULIN WAS WITHHELD AND HE WAS GIVEN A SNACK. HE BEGAN TO FEEL "SHAKY" AT DINNER TIME WITH CONTINUED LOW METER READINGS. HE WAS TRANSPORTED TO THE ER AT 9:45/P WHERE A HOSPITAL METER READING (BRAND UNK) OF 369 MG/DL WAS OBTAINED. HIS METER READ 27 MG/DL AT 9/P. HE WAS TREATED WITH 3U REGULAR INSULIN AND RELEASED HOME. THE METER IS NOT CLEANED OR MAINTAINED ACCORDING TO MFR'S RECOMMENDATIONS. THE TEST STRIP HOLDER IS NOT REMOVED FOR CLEANING OF THE METER OPTICS. CALIBRATION TESTS ARE RARELY, IF EVER PERFORMED. PREVIOUS CHECKSTRIP RESULTS WERE 73, 78, 75 WITH A RANGE OF 75-99, INDICATING LOW METER CALIBRATION.
CO IS UNABLE TO COMPLETE OUR INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE DUE TO THE FACT THAT THE METER WAS NOT RETURNED TO LIFESCAN. THEREFORE, CO HAS NOT BEEN ABLE TO EVALUATE THE METER TO DETERMINE WHETHER OR NOT A DEVICE MALFUNCTION MAY HAVE CONTRIBUTED TO THIS EVENT. BATCH RECORD INDICATES NO NON-CONFORMANCES IN THE MFG PROCESS. AT THIS POINT CO CONSIDERS THIS MATTER CLOSED.
AN AUS DEVICE WAS IMPALNTED ON 1/17/92. THE BALLOON WAS REVISED ON 2/9/93. THE CUFF WAS REVISED ON 6/15/94. THE CUFF AND PUMP WERE REMOVED FROM THE PT ON 9/18/96 DUE TO INFECTION AND EROSION-BULBOUS URETHRA.
THE DEVICE WAS USED DURING LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. THE INSTRUMENT DID NOT CUT. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
OR AXLE MAG W/NUT. DEALER ALLEGES QUICK RELEASE AXLE BROKE-BALL BEARINGS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFORMATION SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC., OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PUMP PERFORMED WITHIN SPECIFICATIONS. CUFF PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFOMRED WITHIN SPECIFICATIONS.
INFORMATION RECEIVED ON 10/23/96 INDICATES INFECTIOM WAS AT THE TUBES.
REMOVAL OF ENDOSSEOUS, DENTAL IMPLANT. THE CLINICIAN REPORTED THAT ONE IMPLANT WAS PLACED IN LOCATION #27 DURING A COMPLEX PROCEDURE. THE BUCCAL LINGUAL RIDGE WIDTH WAS MINIMAL. DURING IMPLANT PLACEMENT, THE RIDGE WAS REDUCED TO GET A WIDER AREA. DENTURE WAS WORN OVER THE IMPLANT. ALTHOUGH AGGRESSIVELY RELIEVED, IT MAY HAVE PREMATURELY LOADED THE IMPLANT. THE IMPLANT WAS REMOVED 3 MONTHS POST-OPERATIVELY.
WHILE AMBULATING, PT EXPERIENCED SUDDEN CRACK IN HIS HIP. X-RAY REVEALED BREAK IN CERAMIC HEAD OF HIP PROSTHESIS IMPLANTED IN 1995. PT REQUIRED SURGICAL REMOVAL AND REPLACEMENT WITH A NEW PROSTHESIS.
GROSS RUPTURE OF A T220L DIALYZER ON ITS 42ND USE. EBL GREATER THAN 100CC. THERE WAS NO PT INJURY REPORTED. TREATMENT RESUMED USING A NEW DIALYZER WITHOUT INCIDENT. THE SAMPLE WAS DISCARDED BY THE CLINIC.
WITHOUT THE ACTUAL DIALYZERS FOR EXAMINATION, IT IS DIFFICULT FOR CO TO DETERMINE THE EXACT CAUSE OF THE LEAKAGE. SINCE THE DIALYZER LEAKED ONT HE 18TH USE, CO CAN PRESUME THAT REPEATED EXPOSURE TO PRESSURIZATION AND CHEMICALS MAY HAVE CONTRIBUTED TO THE OCCURRENCE. THE MFG FACTORY HAS BEEN INFORMED AND THE LOT NUMBER AND PRODUCT CATALOG HAVE BEEN DOCUMENTED.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. THE SURGEON REPORTED THAT NO STAPLES WERE PRESENT IN THE DEVICE WHEN IT WAS FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE PUMP WAS REMOVED FROM HE PT, WOULD NOT ACTIVATE, AND REPLACED.
THE IPP DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER # BZ359 002.
PUMP PERFORMED WITHIN SPECS. RESERVOIR HAD OR DAMAGE. CYLINDER PERFORMED WITHIN SPECS. CYLINDER HAD OR DAMAGE.
THE CUFF WAS REMOVED FROM THE PT, DUE TO EROSION AT THE BULBOUS URETHRA, AND REPLACED.
PARTICULATE WAS SEEN IN THE EYE OF A PT DURING A CATARACT EXTRACTION PROCEDURE USING THIS PHACOEMULSIFICATION HANDPIECE. THIS HANDPIECE WAS USED TO COMPLTE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. ADDITIONALLY, A FILTER TEST WAS PERFORMED AND THE HANDPIECE PASSED THIS TEST.
DELAYED IMPLANT OF THE LEFT CYLINDER DUE TO URETHRAL PERFORATION DURING PREVIOUS PROCEDURE.
THE DEVICE WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. THE INSTRUMENT DID NOT CUT. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE CUFF AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
RUPTURE OF A T220 DIALYZER ON ITS 18TH USE. EBL LESS 100 CC. THE PT'S BLOOD WAS RETURNED, A NEW DIALYZER WAS SET UP, AND TREATMENT WAS RESUMED WITHOUT INCIDENT. THE SAMPLE WAS DISCARDED BY THE CLINIC.
WITHOUT THE ACTUAL DIALYZERS FOR EXAMINATION, IT IS DIFFICULT FOR CO TO DETERMINE THE EXACT CAUSE OF THE LEAKAGE. SINCE THE DIALYZER LEAKED ON THE 18TH USE, CO CAN PRESUME THAT REPEATED EXPOSURE TO PRESSURIZATION AND CHEMICALS MAY HAVE CONTRIBUTED TO THE OCCURRENCE. THE MFG FACTORY HAS BEEN INFORMED AND THE LOT NUMBER AND PRODUCT CATALOG HAVE BEEN DOCUMENTED.
A 42 YR OLD PT REPORTS TAKING INSULIN BASED ON METER READING OF 190. PT THEN MEASURED HER BLOOD GLUCOSE EVERY 15 MINUTES FOR FEAR OF BOTTOMING OUT. NO DATA AVAILABLE ON THESE READINGS. PT CONCERNED WITH A READING AND CONTACTED HER DR, WHO ADVISED DRINKING SOMETHING TO RAISE HER BLOOD GLUCOSE. PT DRANK SUGAR WATER AND CONTINUED TO MONITOR. NO DATA AVAILABLE ON THESE READINGS. CLAIMS THAT IT KEPT DROPPNG. PT PASSED OUT, 911 WAS CALLED AND EMT READING IN THE 300'S WAS OBTAINED (UNK DEVICE). PT TRANSPORTED TO THE HOSPITAL AND STAYED FOR 8 HRS. NO TREATMENT FOR BLOOD GLUCOSE WAS ADMINISTERED AT HOSPITAL OR BY EMT'S. EMT'S DID TREAT WITH NITROGLYCERIN SINCE THOUGHT PT MAY HAVE HAD A HEART ATTACK.
X-RAY REVEALED DEVICE FRACTURED. DEVICE WAS REMOVED AND REPLACED.
EVALUATION CODES FOR SECTION H6:86-100, DEVICE WAS NOT RETURNED, THEREFORE, NO EVALUATION COULD BE MADE. EVENT FREQUENCY AND SEVERITY ARE NOT ADDRESSED IN LABELLING. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
A REVISION SURGERY WAS PERFORMED TO BREAK UP ENCAPSULATION AROUND THE RESERVOIR. NO COMPONENTS WERE REMOVED OR REPLACED. ADD'L LOT/SER#: NI.
THE AUS DEVICE WAS REMOVED FROM THE PT, DUE TO ATROPHY AROUND CUFF, AND REPLACED.
THIS EVENT WAS REPORTED AS A PARAVALVULAR LEAK DUE TO DEHISCENCE. NO FURTHER INFO PROVIDED.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY INC. OR ITS AFFILIATES. D.6. THE EXACT SIZE IS UNK BECAUSE THE COMPLETE CATALOGUE NUMBER WAS NOT PROVIDED. THE MANUFACTURING LOT NUMBER WAS NOT PROVIDED. H.4. THE MANUFACTURING DATE IS UNK BECAUSE THE MANUFACTURING LOT NUMBER WAS NOT PROVIDED.
DURING USE OF THE PUMP, THE INTRA-AORTIC BALLOON PRESSURE WAVEFORMS DID NOT APPEAR TO BE NORMAL. THE PT WAS TRANSFERRED TO ANOTHER PUMP WITH NO COMPLICATIONS.
MFR CONTROL NO. II96-187. THE HOSPITAL DOES NOT HAVE A SERVICE CONTRACT WITH ARROW FOR THIS DEVICE. HOWEVER, THE HOSPITAL'S BIOMEDICAL DEPT. CONTACTED THE ARROW FIELD SERVICE REP, AND DISCUSSED THE PROBLEM. AFTER FURTHER INVESTIGATION, THE PROBLEM WAS DIAGNOSED AS A DEFECTIVE TRANSDUCER. A REPLACEMENT TRANSDUCER WAS ORDERED BY THE HOSPITAL.
THE DISPOSABLE LOADING UNIT WAS USED WITH INSTRUMENT DURING UNSPECIFIED PROCEDURE. THE STAPLES DID NOT FORM PROPERLY. THE SURGEON MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DYNAFLEX DEVICE WAS REMOVED FROM THE PT, REASON NOT INDICATED. AN AMBICOR DEVICE WAS IMPLANTED. AMS HAS REQUESTED ADD'L INFO. INFO RECEIVED ON 6/12/97 INDICATES REASON AS "MALFUNCTION".
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOESMULSIFICATION HANDPIECE WAS BLOCKED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F OF THIS MEDWATCH WAS COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.6 IS THE DATE THE USER BECAME AWARE OF THE MALFUNCTION.
DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS AND "DIFFICULTY INFLATING." ANOTHER DEVICE WAS IMPLANTED.
THE LEFT CYLINDER WAS REMOVED FROM THE PT DUE TO AN ANEURYSM OF LEFT CYLINDER AND INFECTION.
THIS EVENT WAS REPORTED AS MITRAL REGURGITATION, WEAKNESS, SYNCOPE, DIZZINESS AND SHORTNESS OF BREATH. NO FURTHER INFORMATION PROVIDED.
THE BALL HEAD PORTION OF THE TOTAL HIP FEMORAL PROSTHESIS BROKE. NO OTHER INFO WAS PROVIDED TO CO.
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OR THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN MISSION OF LIABILITY OR AN ADMISSION AGAINST THE INTERESTS OF DEPUY ORTHOPAEDICS, INC. OR ITS AFFILIATES.
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FAILED CYLINDERS - WOULD NOT INFLATE.
THE DEVICE WAS REMOVED FROM THE PT DUE TO PAIN-LOW GRADE PROSTHESIS INFECTION. ADD'L LOT/SER NO: 2817T 006.
THIS EVENT WAS REPORTED AS AORTIC INSUFFICIENCY, ENDOCARDITIS AND CORONARY ARTERY DISEASE. NO FURTHER INFO PROVIDED.
THE DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPY PROCEDURE. THE INSTRUMENT DID NOT CUT. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
AN IPP DEVICE WAS IMPLANTED ON 4/26/94. THE CYLINDERS WERE REVISED ON 9/11/96. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 10/16/96 DUE TO INFECTION. ADD'L LOT/SER#: 3234L 003.
DEVICE WAS REMOVED FROM THE PT BECAUSE IT WAS TOO SHORT. ANOTHER DEVICE WAS IMPLANTED.
THE DEALER STATED THE C1000T LEAKED LIQUID OXYGEN OUT THE TOP OF THE CASE AND RETURNED THE UNIT FOR EVAL. SVC TECHNICIAN REPORTED THAT THE FILL TUBE WAS BROKEN OFF AT THE MAINFOLD CONNECTION CAUSING LIQUID OXYGEN TO LEAK. THIS MALFUNCTION COULD POTENTIALLY CAUSE A SERIOUS INJURY IF IT WERE TO RECUR. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MFG PROCESS PER THE APPROVED DMR.
THIS EVENT WAS REPORTED AS SEVERE CALCIFICATION WITH LEAFLET FENESTRATION AND LEAFLET TEAR. NO FURTHER INFO PROVIDED.
PT WAS FOUND TO HAVE CRACKED IMPLANT IN RT KNEE. HE UNDERWENT TOTAL REVISION OF KNEE BECAUSE OF THIS IMPLANT FRACTURE.
THE SOURCE REPORTED THAT THE DEVICE WAS SET-UP DURING PT USE TO DELIVER 5CC OF ACYCLOVIR FROM A BD 10CC SYRINGE, AT A RATE OF 5ML PER HOUR IN VOLUME OVER TIME MODE. AFTER 40 MINUTES, THE PUMP READ VOLUME LIMIT AND ALL 55CC'S HAD BEEN DELIVERED. THERE WAS NO PT INJURY.
H3: THE DOWNLOADED HISTORY WAS ANALYZED, AND INDICATED THAT THE DEVICE INFUSED AS WAS PROGRAMMED BY THE USER AND WITHIN SPECIFICATION. H1: MEDEX DOES NOT CONSIDER THIS EVENT TO BE A MALFUNCTION (OF THE DEVICE) EVENT.
THIS EVENT WAS REPORTED AS CALCIFICATIONS WITH RUPTURE OF COMMISSURE OF THE PROSTHETIC VALVE LEAFLET. NO FURTHER INFO PROVIDED.
H3: EVALUATION OF THE VALVE IN CO'S LABORATORY REVEALED CALCIFICATION WITHIN EACH, ESPECIALLY AT THE ATTACHMENT SITE BETWEEN THE RIGHT AND LEFT-CORONARY CUSP WHICH RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS INCLUDING DETACHED LEAFLETS, AS WELL AS INCOMPLETE COAPTATION. HOST TISSUE OVERGROWTH ENCROACHED ONTO THE LEFT-CORONARY CUSP, CONTRIBUTING TO STENOSIS OF THE VALVE. SECTIONS OF TISSUE WAS MISSING FROM EACH CUSP DUE TO HISTOLOGICAL SECTIONING, PRIOR TO OUR RECEIPT. X-RAY ANALYSIS REVEALED CALCIFICATION WITHIN THE AORTIC WALL, BELLY AND FREE MARGIN OF EACH CUSP. STENT DISTORTION WAS ALSO NOTED AND APPEARED ARTIFACTUAL OF EXPLAINT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO CALCIFICATION. THESE FINDINGS WOULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY. H6 = X-RAY ANALYSIS = 86.
PT FIBRILLATED. DEFIBRILLATION ATTEMPTED FIVE TIMES WITH DEVICE UNSUCCESSFULLY. DEFIBRILLATION SUCCESSFUL WITH ANOTHER DEVICE.
H3: EXAMINATION OF THE VALVE IN CO'S LABORATORY REVEALED NO APPARENT INCONSISTENCIES OTHER THAN MECHANICAL INJURIES WHICH APPEARED ARTIFACTUAL OF EXPLANT. X-RAY ANALYSIS REVEALED NO APPARENT INCONSISTENCIES. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO EMBOLI, AS REPORTED CLINICALLY. H6: 86=X-RAY ANALYSIS.
THE CUSTOMER EVALUATED THE DEVICE AND FOUND THE TRANSFER RELY TO HAVE A LOOSE CONNECTION AT PIN 9. THE TRANSFER RELY WAS REPLACED AND THE UNIT WAS RETURNED TO USE.
THIS EVENT WAS REPORTED AS: DEHISCENCE. THIS DEVICE REMAINS IMPLANTED. NO FURTHER INFO PROVIDED.
THE TUNNELER TIP WAS LOCATED DURING THE INITIAL SURGERY (10/12/96) AND REMOVED FROM THE PT. SUBSEQUENT TO THE INITIAL SURGERY ON 10/12/96, THE IMPLANTED GRAFT (NOT CO'S PRODUCT) CLOTTED, NECESSITATING SURGICAL INTERVENTION. SUBSEQUENTLY, THE PT WENT INTO ORGAN FAILURE AND ULTIMATELY DIED ON 10/14/96, 2 DAYS FOLLOWING THE INITIAL SURGERY.
ACCORDING TO THE OR NURSE PRESENT ON THE CASE: WHEN NOT IN USE, THE TUNNELER WAS KEPT IN A TRAY THAT WAS TOO SHORT TO ACCOMODATE THE LENGTH OF THE TUNNELER. THE TUNNELER HANDLE/ROD WAS BENT. THE OR PERSON, ASSEMBLING THE PRODUCT PRIOR TO SURGERY WAS PROBABLY UNABLE TO ADEQUATELY SCREW THE TIP ON THE HANDLE/ROD.
DEVICE DID NOT WELD. PT WHO IS DEAF AND BLIND COULD NOT HEAR ALARMS OR SEE IF THERE WAS PROBLEM. SUBSEQUENTLY, DEVELOPED PERITONITIS.
THE DEVICE WAS RETURNED WITH A DRAINED BATTERY. THE DEVICE BEEPED 3 TIMES INDICATING A LOW BATTERY, AS DESIGNED. THE DEVICE OPERATED AS INDICATED ACCORDING TO THE DEVICE LABELING AND DEVICE DESIGN. THE BEEP OR LOW BATTERY ALARM IS THERE AS A SAFETY FEATURE TO ASSURE ENOUGH BATTERY POWER TO PERFORM A PROPER WELD. THE BATTERY WAS REPLACED AND WELD INTEGRITY TESTING WAS PERFORMED. THE RESULTS WERE THAT ONE "WET WELD" WAS SLIGHTLY BELOW SPECS. HOWEVER, NO AIR PRESSURE LEAKS WERE FOUND AND ALL OTHER TESTING WERE WITHIN SPECS.
THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THIS TYPE OF EVENT CAN OCCUR. THIS TYPE OF EVENT IS NOT OCCURRING AT A RATE ABOVE EXPECTED FREQUENCY. NO REMEDIAL ACTION WILL BE TAKEN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. A FAX WAS SENT TO THE USER FACILITY ON 10/29/96. CO RECEIVED A MEDWATCH REPORT FORM FROM THE USER FACILITY ON 11/8/96.
THIS PHACOEMULSIFICATION HANDPIECE WOULD NOT WORK DURING A CATARACT EXTRACTION PROCEDURE. A NEW HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.
ORIGINAL SURGERY WAS ON 1/7/95. REVISION SURGERY PERFORMED ON 7/18/96 DUE TO AN ALLEGED BROKEN TIBIAL INSERT. ALTHOUGH FEMORAL COMPONENT, TIBIAL STEM, AND TIBIAL BASE WERE ALSO REVISION, NO COMPLAINT WAS STATED ON THESE.
CONCLUSION STATEMENT: ACCELLERATED WEAR DUE TO DEVICE MISALIGNMENT. PRODUCT WAS MFR AND SOLD BY ANOTHER CO. THE ASSETS OF WHICH WERE PURCHASED BY THIS CO.
THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE CALIBRATED DURING A CATARACT EXTRACTION PROCEDURE. THE PHYSICIAN ENLARGED THE INCISION AND REMOVED THE CATARACT BY EXTRACAPSULAR EXTRACTION (MANUALLY).
RUPTURE OF T220 DIALYZER ON ITS 38TH USE. EBL>100CC. TREATMENT WAS RESUMED USING A NEW DIALYZER WITHOUT FURTHER INCIDENT. SAMPLE WAS DISCARDED BY THE FACILITY.
SINCE THE DIALYZER INVOLVED IN THE EVENT ARE UNAVAILABLE FOR RETURN, IT IS DIFFICULT FOR CO TO CONDUCT A CONCLUSIVE FAILURE ANALYSIS. THE MFG FACTORY HAS BEEN INFORMED OF THE OCCURRENCE AND THE PRODUCT TYPE INVOLVED HAS BEEN DOCUMENTED. CO CAN ONLY PRESUME THAT SOME FACTOR OF REPROCESSING MAY HAVE INFLUENCED THE STRENGTH OF FIBER.
DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE HAD NO POWER. NO OTHER HANDPIECE WAS AVAILABLE AND THE PHYSICIAN REMOVED THE CATARACT MANUALLY. THE PROCEDURE TOOK APPROX 2.5 HOURS LONGER THAN USUAL.
CUSTOMER COMPLAINT COULD NOT BE DUPLICATED.
THE HEALTHCARE WORKER WAS STUCK ON THE PALM OF THE RIGHT HAND WITH THE NEEDLE OF THE ACCESS DEVICE. THIS OCCURRED WHEN THE TEST TUBE WAS BEING WITHDRAWN FROM THE ACCESS DEVICE AND THE NEEDLE DETACHED FROM THE DEVICE.
CO IS NOT MFR OF THIS PRODUCT. THIS INFO IS BEING FORWARDED TO CO WHO IS THE MFR OF THE PRODUCT. A USER FACILITY REPORT WAS NOT RECEIVED FROM THE CUSTOMER. THE INFO PROVIDED IN SECTION F TITLED: FOR USE BY USER FACILITY/DISTRIBUTOR-DEVICE ONLY, IS BEING PROVIDED BY CO. UNLESS SUBSTANTIALLY SIGNIFICANT INFO BECOME AVAILABLE, THIS CONSTITUTES A FINAL REPORT. 21 CFR 803 & 310 REQUIRES THAT THIS REPORT BE FILED WHENEVER THERE IS AN ALLEGATION THAT A REPORTABLE INCIDENT HAS OCCURRED. SOME INFORMATION CONTAINED HEREIN HAS BEEN SUPPLIED BY OTHERS, SIGNIFICANT ADDITIONAL FACTS MAY BE RELEVANT TO THE ALLEGED INCIDENT. IT IS NOT POSSIBLE TO CONCLUDE FROM THIS REPORT WHETHER OR NOT THE MEDICAL DEVICE OR DRUG CAUSED OR CONTRIBUTED TO AN ALLEGED INCIDENT. ***THEREFORE, THIS REPORT MUST NOT BE INTERPRETED AS AN ADMISSION OF FACT OR LIABILITY.***
DEVICE WAS USED DURING A GASTROPLASTY PROCEDURE. A COMPONENT FROM THE KNIFE ASSEMBLY DISENGAGED INTO THE PT'S CAVITY AND WAS RETRIEVED. ADDITIONALLY, THE INSTRUMENT DID NOT FIRE PROPERLY AND TISSUE WAS DAMAGED. SURGEON RESECTED THE DAMAGED TISSUE AND COMPLETED THE PROCEDURE. WITH AN INSTRUMENT.
11/14/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
DURING A CATARACT EXTRACTION PROCEDURE, THE ASPIRATION FUNCTION OF THIS UNIT COULD NOT BE ADJUSTED. IT WAS STUCK ON 70MMHG. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. REBUILT THE ASPIRATION CIRCUIT IN THE PNEUMATICS ASSEMBLY DUE TO BALANCED SALT SOLUTION CONTAMINATION.
DURING AN OPHTHALMIC PROCEDURE ON A DOG IN A VETERINARY CLINIC, THIS UNIT HAD NO POWER. THE PROCEDURE WAS DELAYED 30 MINUTES WHILE A SWITCH WAS MADE TO ANOTHER UNIT.
A FACILITY REPORTED THAT 3 PTS HAD LOST EXCESS FLUID DURING DIALYSIS ON THIS MACHINE. THE EXCESS FLUID LOSSES WERE APPROX 2.85KG; 1.3KG; AND 1KG. TWO PTS WERE HYPOTENSIVE, ONE REQUIRED NORMAL SALINE, THE OTHERS DID NOT. THE TREATMENTS WERE COMPLETED. AFTER THE THIRD TREATMENT THE MACHINE WAS REMOVED FROM THE TREATMENT AREA FOR INSPECTION BY THE FACILITY BIO-MED TECHNICIAN, WHO FOUND A BROKEN UF PUMP OUTLET SPRING. HE REPLACED THE SPRING AND VERIFIED PROPER MACHINE OPERATION. THE PART IS NOT AVAILABLE FOR INSPECTION BY THE MFR. THE FACILITY CONFIRMS THE MACHINE HAS BEEN USED FOR PT TREATMENT WITHOUT ANY PROBLEMS.
BLOCK F. COMPLETED BY THE MFR. F10. SYMPTOMS ADDRESSED IN DEVICE LABEL. BLOCK H3. THE DEVICE WAS EVALUATED BY THE FACILITY MACHINE TECHNICIAN.
THIS EVENT WAS REPORTED AS THROMBOSED GRAFT. THE VASCULAR GRAFT REMAINS IMPLANTED. NO FURTHER INFO PROVIDED.
DURING A VITRECTOMY PROCEDURE, THE VITRECTROMY FUNCTION OF THIS UNIT WOULD NOT CUT. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE.
CUSTOMER CLAIMS SCREWS HOLDING LOWER LIFT BAR AND BLOCK TO MAIN FRAME FELL OUT. ATTENDENT'S FINGERS WERE INJURED.
RE H-6 CODE 810 (FASTENER) FASTENER HAD B3EEN IMPROPERLY INSTALLED.
DEVICE WAS APPLIED DURING A SMALL BOWEL RESECTION PROCEDURE. THE ANVIL DISENGAGED UPON REMOVAL OF THE INSTRUMENT FROM THE CAVITY. AS A RESULT, THE PROXIMAL BOWEL WAS RUPTURED AND THE COLOSTOMY HAD TO BE RECONSTRUCTED. THE HOSP HAS REPORTED THE PT'S STATUS IS SATISFACTORY.
11/14/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THIS EVENT WAS REPORTED AS PULMONIC VALVE STENOSIS. NO FURTHER INFO PROVIDED.
H3: EVALUATION OF THE VALVE IN CO'S LABORATORY WHICH FUSED EACH COMMISSURE AND EACH ATTACHMENT SITE WHICH  RESULTED IN STENOSIS OF THE EFFECTIVE ORIFICE AREA, MULTIPLE DISRUPTIONS AND INCOMPLETE COAPTATION. CALCIFICATION WAS NOTED WITHIN EACH CUSP WHICH CONTRIBUTED TO STENOSIS OF THE VALVE. X-RAY ANALYSIS REVEALED CALCIFICATION WAS NOTED WITHIN THE AORTIC WALL, BELLY AND FREE MARGIN OF EACH CUSP. EXTENSIVE STENT DISTORTION WAS ALSO NOTED AND APPEARED ARTIFACTUAL OF EXPLANT. THE PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO HOST TISSUE OVERGROWTH. THESE FINDINGS COULD ACCOUNT FOR THE SYMPTOMS NOTED CLINICALLY. F10: DEVICE CODE: 2203 = HOST TISSUE OVERGROWTH. H6: 86 = X-RAY ANALYSIS.
ON 10/28/96 DURING A PLATELETPHERESIS THE DONOR RECEIVED 650MLS OF ACD IN APPROX ONE HR (3,000 MLS OF WHOLE BLOOD PROCESSED). THE SYSTEM INDICATED THAT 312 MLS HAD BEEN ADMINISTERED, THE ACD BAG INDICATED 650 MLS GIVEN. WHEN THE KIT WAS BEING REMOVED FROM THE MACHINE THE NURSE NOTICED THAT THE ACD PUMP TUBING HAD ROLLED OFF FROM THE PUMP ROLLER AND HAD BEEN BADLY CHEWED UP BY THE ROLLER. THE NURSE SAID THAT AT THE ONSET OF THE PROCEDURE SHE WAS LOOKING AT THE ACD DRIP CLOSELY AND NOTICED THAT IT WAS DRIPPING NORMALLY, SHE IS SURE THAT THE PUMP HANDLE WAS CLOSED. THE DONOR COMPLAINED THAT HIS LEGS WERE FEELING LIKE LEAD AND WAS NOT FEELING VERY WELL. THE DONOR WAS VERY PALE. NO MEDICATION WAS GIVEN. DONOR RELEASED IN GOOD CONDITION. THE KIT WAS DISCARDED AND NOT AVAILABLE FOR EVAL.
EACH EVENT PROBLEM CODES (PT/DEVICE CODE) ADDRESSED IN LABELING? YES. MFR DESCRIBES IN THE DIRECTIONS FOR USE OF THE DISPOSABLE KIT, THE PROPER TECHNIQUE FOR PLACING THE ACD PUMP TUBING IN THE ACD PUMP AND CLOSING THE ACD PUMP HANDLE OF THE ACCESS MANAGEMENT SYSTEM. UNDER THE ADVERSE EFFECT: A STATEMENT APPEARS ADDRESSING THE EFFECTS THAT A VERY RAPID RATE OR INFUSION OF ANTICOAGULANT HAS ON THE DONOR. INFO IN SECTION F IS PROVIDED BY THE MFR. NO USER FACILITY REPORT RECEIVED. ON 10/30/96, CO'S CLINICAL EDUCATION DEPT CONTACTED THE CUSTOMER AND INFORMED THEM OF THE CORRECT PLACEMENT OF THE ACD TUBING ON THE PUMP ROLLER. EVAL CODE CONCLUSION: 70 (DEVICE DISCARDED, UNABLE TO FOLLOW UP). UNLESS SUBSTANTIALLY SIGNIFICANT INFO BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT. 21 CFR 803 & 310 REQUIRES THAT THIS REPORT BE FILED WHENEVER THERE IS AN ALLEGATION THAT A REPORTABLE INCIDENT HAS OCCURRED. SOME INFORMATION CONTAINED HEREIN HAS BEEN SUPPLIED BY OTHERS. SIGINIFICANT ADDITIONAL FACTS MAY BE RELEVANT TO THE ALLEGED INCIDENT. IT IS NOT POSSIBLE TO CONCLUDE FROM THIS REPORT WHETHER OR NOT THE MEDICAL DEVICE OR DRUG CAUSED OR CONTRIBUTED TO AN ALLEGED INCIDENT. ***THEREFORE, THIS REPORT MUST NOT BE INTERPRETED AS AN ADMISSION OF FACT OR LIABILITY.***
DURING AN OPHTHALMIC PROCEDURE, THIS BIPOLAR CORD HAD NO POWER. ANOTHER CORD WAS USED.
AN IMPLANT FAILED TO INTEGRATE DUE TO INFECTION. PT IS REPORTEDLY FINE.
THIS EVENT WAS REPORTED AS DEHISCENCE POSTERIOR SECTION AND GROSSLY INCOMPETANT, LEAFLETS WERE NORMAL. NO FURTHER INFO PROVIDED.
THIS EVENT WAS REPORTED AS MYOCARDIAL INFARCTION AND INSUFFICIENCY. NO FURTHER INFO PROVIDED.
FOLLOWING OPEN HEART SURGERY, PT DEVELOPED SLOW INFECTION WHICH ULTIMATELY REQUIRED RE-OP TO DEBRIDE STERNUM AND FOLLOWUP ANTIBIOTIC TREATMENT APPROX THREE MONTHS POST-OP.
THIS EVENT WAS REPORTED AS LEAFLET DEHISCENCE AND SEVERE CALCIFICATION. NO FURTHER INFO PROVIDED.
THIS EVENT WAS REPORTED AS: ISCHEMIA AND REGURGITATION. NO FURTHER INFO PROVIDED.
ON 11/10/93 AN AUS DEVICE WAS IMPLANTED ON 5/13/94 THE CUFF WAS REVISED. ON 10/31/96 THE CUFF WAS REMOVED FROMT HE PT AND REPLACED DUE TO RECURRING INCONTINENCE.
FOLLOWING OPEN HEART SURGERY, PT DEVELOPED SLOW INFECTION WHICH ULTIMATELY REQUIRED RE-OP TO DEBRIDE STERNUM AND FOLLOW UP ANTIBIOTIC TREATMENT APPROX FOUR MONTHS POST-OP.
DEVICE WAS USED DURING A LOW ANTERIOR RESECTION/COLOSTOMY PROCEDURE. PT WAS SIZED FOR A 31MM STAPLER; HOWEVER, THE HOSP DID NOT HAVE ANY IN STOCK SO THE SURGEON APPLIED A 28MM STAPLER. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. PT WAS RE-ADMITTED 7 DAYS LATER AS 80% OF THE ANASTOMOSIS HAD FAILED. A COLOSTOMY WAS PERFORMED TO CORRECT THE CONDITION. PT EXPIRED 7 (10/3/96) DAYS POST-OP DUE TO THE BOWEL LEAKAGE THAT OCCURRED.
THIS EVENT WAS REPORTED AS CLOTTED. NO FURTHER INFO PROVIDED.
THIS EVENT WAS REPORTED AS CONGESTIVE HEART FAILURE, ANGINA, HISTORY OF ENDOCARDITIS, PULMONARY HYPERTENSION AND REGUGITATION.
INFO RECEIVED ON 12/27/96 INDICATES THE PUMP AND BALLOON WERE REMOVED FROM THE PT, DUE TO FLUID LOSS AT A CONNECTOR, AND REPLACED.
CO WAS CONTACTED DIRECTLY BY SURGEON WHO STATED THE PT HAD A SEVERE SKIN REACTION TO SKIN STAPLES USED AFTER A CORONAY ARTERY BYPASS GRAFT. THE REACTION OCCURRED APPROX 20 DAYS AFTER THE SURGERY.
UNAVAILABLE DEVICE WAS NOT RETURNED FOR EVAL.
PT EXPIRED FOLLOWING THE IMPLANT OF A CEMENTED PROSTHESIS.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "N", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? UNK. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "N", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? UNK. DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR IS NOT AVAILABLE. NO ADD'L INFO WILL BE SUBMITTED WITHOUT WRITTEN REQUEST.
THE ENTIRE DEVICE WAS REMOVED FORMT HE PT BECAUSE THE DEVICE ERODED INTO THE URETHRA.
CUFF HAD A FATIGUE LEAK. BALLOON PERFORMED WITHIN SPECIFICATIONS.
TEH DEVICE WAS IMPLANTED ON 2/27/96 FOR HEPATIC ARTERIAL INFUSION OF CHEMOTHERAPY. ON 10/18/96, THE PT CONTACTED A MFR NURSE AND REPORTED THAT THE DEVICE HAS BECOME DETACHED FOR THE SECOND TIME. THE FIRST TIME IT BECAME DETACHED WAS ON 7/9/96 WHEN IT WAS RESUTURED WITH NON-ABSORBABLE SUTURES USING ALL FOUR SUTURE LOOPS AFTER IT HAD FLIPPED IN THE DEVICE POCKET. THE PT STATED THAT SHE HAD "VERY LITTLE SPACE BETWEEN HER WAIST AND GROIN, AND THE DEVICE CURRENTLY DIGS INTO HER HIP AND INTERFERES WITH BENDING." THE PT STATED THAT IT DOES NOT HURT AND THAT IT "IS JUST ANNOYING." THE PT THEN INQUIRED IF WEARING A SUPPORT WOULD BE OKAY. THE PT ALSO STATED THAT SHE HAS LOST FORTY POUNDS; HOWEVER, SHE IS STILL OVERWEIGHT. THE MFR NURSE SUGGESTED THAT THE DEVICE SIDEPORT BE TURNED INWARD TO AVOID THE HIP. IN ADDITION, THE MFR NURSE STATED THAT SHE WOULD FORWARD AN ACRYLIC MODEL OF THE DEVICE TO THE PT'S SURGEON SO THAT HE AND THE PT CAN SELECT A MORE COMFORTABLE PLACEMENT. THE MFR ALSO SUGGESTED THAT THE DEVICE SUTURES BE SECURED TO THE FASCIA, NOT THE FATTY TISSUE, WITH A LARGER SECTION TO ANCHOR TO.
ON 12/12/96, THE MANUFACTURER NURSE CONTACTED THE PT TO OBTAIN FOLLOW UP INFORMATION. THE PT REPORTED THAT "TWO WEEKS AGO", THE DEVICE FLOW RATE HAD DECREASED AND A DYE STUDY SHOWED A BLOCKAGE SOMEWHERE IN THE DEVICE CATHETER. IN ADDITION THE PT REPORTED THAT SURGERY WAS PERFORMED WITH A MANUFACTURER REPRESENTATIVE PRESENT AND THE DEVICE CATHETER WAS FOUND TO BE "WOUND UP" AND WAS KINKED. THE PT THEN STATED THAT THE DEVICE WAS REATTACHED AND "ALL SEEMS FINE NOW." ON 12/12/96, THE MANUFACTURER SALES REPRESENTATIVE PROVIDED THE FOLLOWING DETAILS CONCERNING THE DEVICE POCKET REVISION SURGERY WHICH WAS PERFORMED ON 11/25/96: THE DEVICE POCKET WAS OPENED AND THE DEVICE APPEARED TO HAVE FLIPPED NUMEROUS TIMES BECAUSE THE CATHETER WAS EXTREMELY COILED TO THE EXTENT THAT THE DEVICE WAS NO LONGER FLOWING. THE CATHETER WAS UNCOILED AND THE CATHETER AND THE OTHER DEVICE WERE TESTED WITH RADIOPAQUE DYE WHICH DID NOT REVEAL ANY LEAKS OR OTHER PROBLEMS. THE POCKET WAS THEN MOVED SLIGHTLY, AS NOT TO INTERFERE WITH THE PT'S HIP BONE, AND THE DEVICE WAS RESUTURED AND THE POCKET WAS THEN CLOSED. THE DEVICE APPEARS TO BE FUNCTIONING AS INTENDED AND WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS PART/SERIAL NUMBER AND NO MANUFACTURING VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS PART NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THIS EVENT APPEARS TO HAVE BEEN RELATED TO PHYSIOLOGICAL/PROCEDURAL RELATED FACTORS AND WAS NOT DUE TO A DEVICE MALFUNCTION OR FAILURE. NO FURTHER DETAILS ARE AVAILABLE. THE MANUFACTURER IS NOW CLOSING ITS FILE ON THIS EVENT.
THIS EVENT WAS REPORTED AS THROMBOSIS. NO FURTHER INFO PROVIDED. THIS DEVICE REMAINS IMPLANTED.
DURING AN UNSPECIFIED PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO REMOVE FROM TISSUE. SURGEON MANUALLY MANIPULATED THE DEVICE FREE AND COMPLETED THE PROCEDURE WITHOUT INCIDENT.
RPTR NOTED A CORNEAL BURN (TISSUE SHRINKAGE) AFTER PHACOEMULSIFICATION. USED LOOSE SUTURES TO CLOSE WOUND. CUSTOMER WANTS SYSTEM AND HANDPIECE TO BE EVALUATED.
H-10: A CO SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND HANDPIECE S/N IUHP181336. THEY WERE EACH FOUND TO MEET THEIR PERFORMANCE SPECIFICATIONS. CONSUMABLES AND TIP WERE NOT SAVED FOR EVAL. MISSING INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. H-11: SECTION F INFO PROVIDED BY USER FACILITY. THIS REPORT WAS MAILED IN TO FDA ON: 11/15/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE DEVICE WAS IMPLANTED ON 3/7/96 FOR INTRATHECAL INFUJSION OF MORPHINE FOR TREATMENT OF PAIN. ON 10/17/96, A MFR CLINICAL REPRESENTATIVE WAS PRESENT AT THE FACILITY TO ASSIST THE PHYSICIAN IN REFILLING THE DEVICE AS SHE HAD RECENTLY "INHERITED" THIS PT AND THIS WAS ONLY HER SECOND TIME ACCESSING THE DEVICE. THE DEVICE EMPTIED QUICKY AND A RETURN VOLUME OF 24.5CC WAS OBTAINED. THE REFILL PERIOD =44 DAYS, FLOW RATE =0.579 ML/DAY. THE PREDICTED FLOW RATE FOR THIS DEVICE IS 0.96 ML.DAY. THE PHYSICIAN REPORTED THAT THIS PT IS NOT PAIN CONTROLLED AND PLANNED ON HAVING THE PT RETURN TO HER OFFICE ON 10/23/96. NO AIR WAS RETURNED WHEN THE DEVICE WAS FILLED WITH 50CC WHICH WAS ALLOWED TO RETURN AND THEN REFILLED AGAIN. THE PT STATED THAT HE WAS "NEVER PAIN CONTROLLED"; HOWEVER, HE REPORTED EXPERIENCING "SOME SLIGHT RELIEF LAST MONTH." THE PT ALSO REPORTED THAT THE DEVICE HAD BEEN EMPTY FOR SIX WEEKS DUE TO HIS SWITCHING PHYSICIANS. THE PHYSICIAN PERFORMED A FLUOROSCOPIC DYE STUDY LAST MONTH WHICH CONFIRMED INTRATHECAL CATHETER PLACEMENT.
ON 11/13/96, THE PHYSICIAN REPORTED THAT SHE WAS DISSATISFIED WITH THE RESPONSE SHE HAD GOTTEN FROM THE MFR AND WAS "VERY TEMPTED" TO EXPLANT THE DEVICE AND SEND A WRITTEN REPORT TO THE FDA DETAILING THE CIRCUMSTANCES OF THIS EVENT. THE PHYSICIAN WAS INFORMED THAT THE MFR HAS ALREADY REPORTED THE INCIDENT TO THE FDA, PER CURRENT FDA REGULATIONS. THE PHYSICIAN THEN REQUESTED TO BE GIVEN THE NAME OF ANOTHER PHYSICIAN WHO HAS HAD SIMILAR EXPERIENCES WITH THE DEVICE AND ALSO REQUESTED A LETTER FROM THE MFR STATING THE OPINION TO EXPLANT THE DEVICE OR TO WORK WITH THE DEVICE AT THE CURRENT FLOW RATE. ON 11/14/96, THE PHYSICIAN REPORTED THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL AND WAS "NOT DOING WELL". THE PHYSICIAN STATED THAT THE PATIENT WAS THROWING UP BLOOD AT ADMISSION, HAD SEVERE NAUSEA AND COULD NOT KEEP SOLIDS DOWN, DID NOT LOOK WELL, AND WAS ON IV MORPHINE DRIP FROM A PCA PUMP. THE NEXT DEVICE REFILL SCHEDULED ON 11/15/96 WAS CANCELED UNTIL THE PATIENT BECOMES MORE STABLE. ON 11/20/96, THE MFR'S VICE PRESIDENT, SALES & MARKETING SENT A WRITTEN RESPONSE TO THE PHYSICIAN WHICH PROVIDED THE INFO SHE HAD REQUESTED CONCERNING THE NAME OF ANOTHER PHYSICIAN WHO WAS WILLING TO SPEAK WITH HER ABOUT HER PRESENT CONCERNS WITH THE DEVICE. THE LETTER ALSO REQUESTED THAT THE PHYSICIAN CONTACT THE MFR'S CLINICAL SERVICES TO LET US KNOW HOW SHE WOULD LIKE TO PROCEED. ON 12/10/96, THE MFR SALES REP. REPORTED THAT THE DEVICE HAD BEEN EXPLANTED ON 12/6/96. THE FACILITY DID NOT WISH A MFR REP. TO BE PRESENT AT THE EXPLANT. AT THE TIME OF EXPLANT, 17.5CC WAS RETURNED FROM THE DEVICE RESERVOIR, REFILL PERIOD = 51 DAYS. A DYE STUDY WAS THEN DONE WHICH REVEALED THE DEVICE CATHETER TO BE PATENT AND WITHOUT KINKS. THE DEVICE CATHETER WAS THEN CUT AND REATTACHED TO ANOTHER MFR'S PROGRAMMABLE IMPLANTABLE INFUSION DEVICE. THE PATIENT IS REPORTED AS DOING WELL. THE PHYSICIAN DOES NOT WISH TO RETURN THE EXPLANTED DEVICE TO THE MFR FOR ANALYSIS. SINCE THE DEVICE WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS, CO'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PART/SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD PERFORMED ON THIS PART/SERIAL NUMBER DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS PART NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. BASED ON THE AVAILABLE INFO, AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE PHYSICIAN WILL BE NOTIFIED OF THE MFR'S INVESTIGATION FINDINGS. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
THE PUMP WAS REMOVED FROM THE PT AND REPLACED DUE TO "PUMP HAS BROKEN".
A YAG PROCEDURE WAS PERFORMED ON THE PT APPROX TWO WEEKS PRIOR TO THE DATE OF THE EVENT. THE LENS SUBSEQUENTLY ENDED UP IN THE VITREOUS. THE LENS WAS EXPLANTED ON 10/21/96 AND A VITRECTOMY WAS PERFORMED. THE LENS WAS NOT RETURNED FOR EVALUATION. EXPIRATION DATE: 10/24/00.
F10: DEVICE CODE - 1360 DECENTRATION OF LENS. F13: REPORT SENT TO MFR? REPORTED BY FAX, NOT ON 3500A FORM. H6: PRODUCT NOT RETURNED FOR EVALUATION, NO METHOD, RESULTS, OR CONCLUSIONS CAN BE DRAWN.
DURING I/A, THE SYSTEM SHUT DOWN AND RESTARTED, CAUSING A POSTERIOR CAPSULE TEAR AND VITREOUS LOSS. INFORMED THAT THE OVERHEAD LIGHTS HAD ALSO BEEN AFFECTED (FLICKERED), BUT ELECTRICAL ENGINEER PERFORMED CHECKS AND FOUND NO PROBLEMS.
H-10 A CO SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND FOUND IT TO MEET ITS PERFORMANCE SEPCIFICATIONS. NO CONSUMABLES WERE SAVED FOR EVAL. MISSING INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. H-11: SECTION F INFO PROVIDED BY USER FACILITY. THIS REPORT WAS MAILED IN TO FDA ON: 11/15/96. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
THE CATHETER WAS IN USE ON AN 87-YR-OLD ORTHOPEDIC PT. WHEN THE CATHETER WAS REMOVED A 6-7CM PIECE OF THE OUTER COATING SEPARATED AND REMAINS IN THE PT. NO INFO REGARDING THE REMOVAL OF THE SEPARATED PORTION OF THE CATHETER HAS BEEN RECEIVED TO DATE.
DEVICE WAS APPLIED DURING AN ESOPHAGO GASTRECTOMY PROCEDURE. NO LEAKAGE WAS OBSERVED AFTER THE DEVICE WAS FIRED. AN X-RAY TAKEN FIVE DAYS POST-OPERATIVELY REVEALED A LARGE LEAK. SURGEON RE-OPENED PT AND OBSERVED APPROX. 1CM SPACE IN THE MIDDLE OF THE STAPLE LINE. ORGINAL APPLICATION SITE WAS RESECTED AND THE SURGEON MANUALLY SUTURED A NEW ANASTOMOSIS. HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
11/13/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
A STONE RETRIEVAL PROCEDURE, UTILIZING A RETRIEVAL BASKET AND A LASER FIBER, AS WELL AS 529 3SWL PROCEDURES WERE PERFORMED IN MARCH 1995. SUBSEQUENTLY, THE PT DEVELOPED PAIN. IN MARCH 1996, A SECOND STONE REMOVAL PROCEDURE WAS PERFORMED. STONES AND DEBRIS, BELIEVED TO BE SEGMENTS OF A DEVICE USED DURING THE INITIAL PROCEDURE IN MARCH 1995, WERE REMOVED AT THAT TIME. THE PT'S CONDITION PRESENTLY IS GOOD. NO DEVICE SEGMENTS WERE RETURNED FOR EVALUATION, HOWEVER, A PHOTOGRAPH OF THE DEBRIS AND CALCULI REMOVED WAS FORWARDED TO THIS MFR. NO INDENTIFICATION OF THE DEBRIS COULD BE MADE FROM THE PHOTOGRAPH SUPPLIED BY THE USER FACILITY.
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE UF. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS "NA" AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
PUMP PERFORMED WITHIN SPECS. CUFF HAD A WEAR LEAK. BALLOON PRESSURE NOT WITHIN SPECS.
NEEDLE BREAKAGE DURING SURGERY. NEEDLE RETRIEVED CAUSING PT SLIGHT DISCOMFORT.
THE ACTUAL NEEDLE INVOLVED IN THIS INCIDENT WAS RETURNED ALONG WITH SEVERAL UNOPENED PACKETS OF THE SAME LOT. EVALUATION INCLUDED VISUAL AND SCANNING ELECTRONMICROSCOPY ALONG WITH MECHANICAL TESTING. NO VISUAL NONCONFORMANCES WERE OBSERVED AND EACH NEEDLE MET THE ETHICON REQUIREMENTS FOR STRENGTH AND DUCTILITY. IT WAS CONCLUDED THAT THE BROKEN NEEDLE FRACTURED IN A DUCTILE MANNER DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION. NUMEROUS GOUGES PRODUCED DURING HANDLING WITH NEEDLE HOLDERS WERE OBSERVED AND THE NEEDLE WAS SIGNIFICANTLY BENT BEFORE FRACTURED OCCURRED. A PRODUCT INQUIRY RECORDS REVIEW WAS CONDUCTED AND THERE HAVE BEEN NO OTHER INQUIRIES OF ANY TYPE INVOLVING THIS BATCH NUMBER.
DEVICE WAS APPLIED DURING AN ESOPHAGO GASTRECTOMY WITHOUT ANY DIFFICULTIES. POST OPERATIVELY, THE STOMACH WAS NOT EMPTYING PROPERLY. A RE-OPERATION WAS PERFORMED FIVE DAYS POST OPERATIVELY. (9/23/96) THE STAPLE LINES CAME APART. SURGEON STATED THE TISSUE WAS RADIATED EXTENSIVELY AND MAY NOT HAVE BEEN HEALTHY. STAPLE LINES WERE RESECTED AND HE MANUALLY SUTURED A NEW ANASTOMOSIS. HOSP HAS STATED THE PT'S STATUS IS SATISFACTORY.
A  CONNECTOR WAS REVISED DUE TO TUBING FRACTURE. NO COMPONENTS WERE REMOVED OR REPLACED.
SUTURE BREAKAGE POST OP; 9 DAYS AFTER AORTIC VALVE REPLACEMENT/CABG/ASCENDING AORTA PLICATION SURGERY, PT HEMORRHAGED LEADING TO DEATH.
SAMPLES RETURNED WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND THE RESULTS OBTAINED WERE ABOVE THE ETHICON REQUIREMENTS, WHICH ALWAYS EQUAL OR EXCEED THE MINIMUM USP REQUIREMENTS. RECORDS OF IN-PROCESS AND FINISHED GOODS DATA FOR LOT TESTED WAS ALSO REVIEWED AND FOUND TO MEET PRODUCT SPECIFICATIONS.
AFTER REVIEWING THE DATA IT APPEARS THAT THE DEVICE USED WAS MEASURING IMPEDANCES THAT WERE CONSISTENT WITH THE PSA MEASUREMENTS TAKEN. THERE WERE IMPEDANCE VARIATION OF ANOTHER CO'S LEAD (930 VS. 1300 OHMS) AND PERHAPS THE OTHER CO'S ANALYSIS WILL TURN UP SOMETHING. THE ONLY STRIDE IMPEDANCE THAT SEEMS STRANGE IS THE UNIPOLAR 3.5V WITH OTHER CO LEAD. COULD BE DUE TO BAD READING DUE TO A WAND POSITION WITH THE PACER POCKET.
THE PT WAS CONNECTED TO THE VENTILATOR. THE CUSTOMER REPORTS THAT THE VENTILATOR HELD A POSITIVE 20 CM H2O OF PEEP DURING AN OR PROCEDURE. THE VENTILATOR WAS REMOVED FROM THE PT.
200 - THE VENTILATOR WAS EVALUATED BY ECRI, ALONG WITH A CO'S FIELD REP PRESENT. THE RESULTS FOUND A CALIBRATION SETTING TO BE OUT OF SPEC. THIS INFO WILL BE FORWARDED TO THE MFR.
ON 6/27/96 AN AUS DEVICE WAS IMPLANTED. ON 8/6/96 THE CUFF WAS REVISED. ON 10/02/96 THE CUFF WAS REMOVED FROM THE PT DUE TO EROSION DISTAL CUFF.
HOIST WAS USED FOR FIRST TIME FOLLOWING COMMISSION, WITH A MALE PT. UPON RAISING THE HOIST TITLED OVER AND ONE CHASSIS LEG WAS FOUND TO BE NOT LOCKED IN POSITION. SINCE THIS THE STAFF HAVE NOT BEEN ABLE TO SAFELY LOCK THIS LEG. NO INJURY WAS REPORTED.
THE FOLLOWING IS A CLOSING OUT REPORT FROM THE FOREIGN REPORTER. INVESTIGATION: THE ENVIRONMENT WAS A NEW UNIT WHICH WAS CARPETED. OBSERVATIONS: UPON EXAMINATION OF THE HOIST, IT WAS FOUND THAT THE RIGHT HAND LEG LOCKING CATCH WAS NOT LOCATED. THE INVESTIGATOR PLACED FOOT ON LEG AND RAISED THE JIB BY HAND TO ALLOW CATCH TO ENGAGE. THERE WAS NO FAULT FOUND WITH THE CATCH. CONCLUSIONS: THE INCIDENT WAS A RESULT OF OPERATOR ERROR. CORRECTIVE ACTION: THE INVESTIGATOR SHOWED GENERAL MANAGER HOW TO LOCATE LEG BY RAISING JIB BY HAND KEEPING FOOT ON LEG UNTIL THE CATCH IS LOCATED.
DEVICE WAS USED DURING A COLON RESECTION PROCEDURE. INSTRUMENT WOULD NOT RELEASE FROM THE TISSUE. SURGEON RESECTED THE TISSUE AT THE APPLICATION SITE TO REMOVE THE DEVICE. ANOTHER INSTRUMENT WAS APPLIED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY.
PT HAD BEEN PLACED ON INTERMITTENT SUCTION. AT SHIFT CHANGE BLOOD WAS FOUND IN THE SUCTION TUBING. THE INTERMITTENT SUCTION REGULATOR WAS SET AT 140 MM/HG, NOT WHERE IT HAD BEEN SET. THE PT WAS LAVAGED UNTIL NO BLOOD PRESENT. A NEW GASTRIC TUBE WAS PLACED.
USER FACILITY CONTACTED CONCERNING EVENT. CONTACT PERSON STATED THAT GASTRIC TUBE WAS NOT AT FAULT, BUT THAT SUCTION DEVICE HAD FAILED.
THE PUMP AND CUFF WERE REMOVED FROM THE PT, DUE TO AIR IN THE SYSTEM, AND REPLACED.
PUMP WAS FUNCTIONAL. CUFF PERFORMED WITHIN SPECIFICATIONS.
PURSUANT TO INFO RECEIVED FROM THE PHYSICIAN, PT WAS BILATERALLY IMPLANTED WITH DEVICES ON 6/5/86. SUBSEQUENTLY THE PT DEVELOPED AUTO-IMMUNE TYPE SYMPTOMS AND THE PHYSICIAN REMOVED THE DEVICES. NO ADD'L INFO REGARDING THIS OCCURRENCE THE PHYSICIAN NOTED IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANUY INFO CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" SEE PRODUCT EVALUATION ATTACHED HERETO. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (MENTOR EFFECTIVE DATE, 2/10/92). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21 CFR 803. ADD'L INFO TO BE SUBMITTED Y/N? Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUSAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES" IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N.
IT WAS REPORTED THE BALLOON BROKE INSIDE THE PT DURING DILATATION OF AN ILIAC STENT. THE PT UNDERWENT SURGICAL RETRIEVAL OF THE BALLOON. TO DATE, ATTEMPTS TO OBTAIN FURTHER DETAILS REARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT, AS WELL AS PT CONDITION, HAVE BEEN SUCCESSFUL. SHOULD FURTHER DETAILS BECOME AVAILABLE, A SUPPLEMENT WILL BE FORWARDED UNDER 1219544-1996-00147. AT THIS TIME, THE USER FACILITY CANNOT LOCATE THE BALLOON CATHETER. THEREFORE, A FAILURE ANALYSIS WILL NOT BE AVAILABLE. IT WAS INDICATED THIS DEVICE WAS USED IN AN EXISTING STENT WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THIS PROCEDURE IS NONINDICATED FOR THIS DEVICE, THEREFORE CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE. CO DIRECTIONS FOR USE STATE: "THESE BALLOON DILATATION CATHETERS ARE RECOMMENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE ILIAC, FEMORAL AND RENAL ARTERIES AND FOR THE TREATMENT OF OBSTRUCTIVE LESIONS OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE... ANY USE FOR PROCEDURES OTHER THAN THOSE RECOMMENDED IN THESE INSTRUCTIONS IS NOT RECOMMENDED."
DEVICE WAS USED DURING THE REVERSAL OF HARTMANNS PROCEDURE. INSTRUMENT DID NOT FIRE PROPERLY. SURGEON REPORTED THAT HE TESTED THE ANASTOMOSIS AND DETECTED A PROBLEM. HE THEN RESECTED THE TISSUE AROUND THE STAPLE AND PERFORMED A TEMPORARY COLOSTOMY BY HAND. THE HOSP HAS REPORTED THAT THE PT'S CONDITION IS SATISFACTORY.
1/22/97 - SUPPLEMENTAL REPORT #1 SENT TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
THE RPORTER INDICATED THAT THERE WAS NO CONTACT WITH THE PROGRAMMER 522-06-08736 AND 531-49L-200184, SERIAL NUMBER RECEIVED FROM THE DEVICE IS NOT RECOGNIZED AS VALID. THERE WERE NO SPIKES RECOGNIZED WITH MAGNET.
THIS EVENT WAS REPORTED AS RHEUMATIC REGURGITATION. NO FURTHER INFO PROVIDED.
ON 11/12/96, TWO MFR REPS MET WITH 4 DRS AT THE FACILITY TO OBTAIN ADD'L INFO ON 3 SPINAL ABCESS EVENTS. AT THAT TIME, A 4TH INCIDENT WAS REPORTED. THIS REPORT INVESTIGATES THE 4 INCIDENT. THE INFO PROVIDED WAS NOT DISTINCT TO EACH PT INVOLVED, THEREFORE, ALL OF THE INFO PROVIDED HAS BEEN COPIED TO EACH REPORT. DURING THEIR DISCUSSION IT WAS REVEALED THAT ALL 4 PTS HAD EPIDURAL DEVICE CATHETER PLACEMENT AND ALL 4 HAD MRI TO CONFIRM GROWTHS. IT WAS ADDITIONALLY STATED THAT ALL 4 PTS HAVE DEVICE CATHETERS WHICH STOP BELOW THE GRANULOMA AND ALL 4 ARE CHRONIC PAIN PTS WHO EXPERIENCE GREAT PAIN RELIEF. THE 4 PTS ARE BEING TREATED AS FOLLOWS: ONE PT IS RSD; ONE PT IS BEING TREATED FOR A FAILED BACK; ONE PT IS BEING TREATED FOR ABDOMINAL ADHESIONS, AND ONE PT IS BEING TREATED FOR CHRONIC PANCREATITIS. OF THE 4 PTS, ONE WAS CULTURED FOR INFECTION WHICH WAS STAPH AUREUS. BETWEEN THE 4 PTS TWO DIFFERENT TYPES OF DRUGS WERE BEING UTILIZED: MORPHINE AND DELANDID.
REVIEW OF THE IMPLANT RECORD, ON 11/15/96, REVEALED THAT THIS DEVICE WAS IMPLANTED ON 4/9/96 FOR EPIDURAL INFUSION OF HYDROMORPHONE. IN ADDITION, ON 11/20/96, THE MFR WAS NOTIFIED THROUGH ITS DEVICE TRACKING SYSTEM THAT THIS DEVICE WAS EXPLANTED ON 6/27/96 BY THEY PHYSICIAN, DUE TO THE PATIENT "DEVELOPED SPINAL ABCESS AS THICK AS THE SPINE". A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THIS DEVICE AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THESE CATALOG NUMBERS AND HAS NOT IDENTIFIED ANY TRENDS. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS THE CAUSE OF THIS EVENT. THE FACILITY WILL BE NOTIFIED OF CO'S REVIEW OF THIS INCIDENT. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT. SECTION D5 THE EXPIRATION DATE WAS REPORTED AS 8/28/97. THE CORRECT EXPIRATION DATE FOR THIS DEVICE IS UNK.
APPROX 3-5 DAYS AFTER THE CATHETER HAD BEEN REMOVED, THE PT DEVELOPED A CLOT IN THE AORTA AND DIED OF RENAL FAILURE. THE PHYSICIAN COULD SEE NOTHING VISIBLY WRONG WITH THE CATHETER. THE CLOT CONTINUED TO GROW IN THE AORTA, EVEN AFTER REMOVAL OF THE CATHETER.
THE PHYSICIAN AT THE TREATING FACILITY STATED THAT THE CATHETER HAD BEEN REMOVED AND DISCARDED, SO IT WAS UNAVAILABLE FOR EVAL. A DEVICE HISTORY REVIEW WAS NOT POSSIBLE AS THE PHYSICIAN INDICATED THAT THE LOT NUMBER WAS UNAVAILABLE.
WHILE BEING PICKED UP PT HIT HEAD ON ARM THUS CAUSING A LACERATION. PT HIT HEAD ON END OF BAR.
UPON INSPECTION THE LIFT WAS FOUND IN GOOD CONDITION EXCEPT FOR THE END CAPS WHICH WERE BROKEN. THE ISSUE OF BROKEN END CAPS HAS BEEN ADDRESSED THRU MFG WORK ORDER 01123. CAUSE OF EVENT WAS IMPROPER MAINTENANCE OF THE LIFT. IF THE CUSTOMER DOES NOT HAVE THE MANUAL THEY ARE TO REQUEST ONE.
DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. INSTRUMENT COULD NOT BE REMOVED FROM THE TISSUE AFTER FIRING. SURGEON RESECTED TISSUE AND MANUALLY SUTURED TO COMPLETE THE PROCEDURE. HOSP HAS REPORTED THAT THE PT'S CONDITION IS SATISFACTORY.
PUMP HAD OR DAMAGE. CUFF PERFORMED WITHIN SPECS. BALLOON PERFORMED WITHIN SPECS.
THE REPORTER INDIACTED THAT THERE WAS A LEAD WIRE FRACTURED.
REFERNECE F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE COIL FRACTURED AT THE BASE OF THE CONNECTOR PIN AS A RESULT OF FATIQUE. THE SILICONE BOOT WAS ALSO TORN IN THIS AREA INDICATING A HIGH LEVEL OF STRESS WAS PRESENT.
AN AUS DEVICE WAS IMPLANTED ON 9/24/86. THE CUFF WAS REVISED ON 1/6/87 AND 6/10/96. THE BALLOON WAS REVISED ON 10/15/90. ON 10/7/96 THE CUFF AND PUMP WERE REMOVED FROM THE PT DUE TO RECURRING INCONTINENCE-BALLOON LEFT IN PLACE. AN ENTIRE AUS DEVICE WAS IMPLANTED.
PUMP WAS FUNCTIONAL. CUFF HAD OR DAMAGE.
THIS EVENT WAS REPORTED AS STENOSIS AND INSUFFICIENCY. NO FURTHER INFO PROVIDED.
CATHETER WAS IMPLANTED ON 7/11/96. CATHETER WAS SEVERED ALONG THE LINE. SURGEON RE-OPERATED ON 10/18/96 TO REMOVE THE DAMAGED CATHETER AND IMPLANT A NEW ONE. HOSP HAS REPORTER THAT THE PT'S CONDITION IS SATISFACTORY.
11/14/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. DEVICE WAS RECEIVED WITH THE CATHETER SPLIT IN TWO PIECES. THE SPLIT EDGES WERE JAGGED AND DISPLAYED DAMAGE CONSISTENT WITH THE CATHETER BEING TRAPPED IN THE ANATOMICAL PINCH POINT BETWEEN THE CLAVICLE AND THE FIRST RIB. THIS CONDITION IS CAUTIONED AGAINST IN THE INFO BOOKLET THAT ACCOMPANIES EACH PRODUCT SHIPMENT.
ACCORDING TO CLINICIAN, 3 IMPLANTS WERE PLACED IN CLASS III BONE DURING ROUTINE SURGERY. THE IMPLANT IN SITE #22 REPLACED A FAILED 31 FIXTURE IN AN IMMEDIATE EXTRACTION SITE. BONE QUALITY IN THE SITE WAS POOR. THE IMPLANT WAS REMOVED 2 MONTHS POST-OPERTIVELY.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS IMPLANTS IS BELOW THE EXPECTED RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
THE REPORTER INDICATED THAT THERE WAS A LEAD WIRE FRACTURED.
REFERENCE SECTION F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE COIL FRACTURED AT THE BASE OF THE CONNECTOR PIN AS A RESULT OF FATIQUE. THE SILICONE BOOT WAS ALSO TORN IN THIS AREA, INDICATING A RELATIVELY HIGH STRESS LEVEL WAS PRESENT.
AN AUS DEVICE WAS IMPLANTED ON 5/8/87. THE BALLOON WAS REVISED ON 8/30/87. THE CUFF AND BALLOON WERE REVISED ON 6/9/88. THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 10/10/96, DUE TO PUMP TUBING BROKEN OFF, AND REPLACED.
THE DEVICE WAS USED DURING AN ENDOSCOPIC VEIN HARVEST. IT WAS REPORTED THAT THE TRANSPARENT BLUNT TIP DISSECTOR ON THE SVSD1 BROKE AND A PIECE WAS IMBEDDED INTO THE PT'S LEG MUSCLE. AFTER ONE HR OF EXPLORING FOR THE BROKEN PIECE THE SURGEON DECIDED TO CONVERT TO AN OPEN PROCEDURE AND WAS ABLE TO RETRIEVE THE BROKEN PIECE.
H6; CODE 100: INSTRUMENT WAS RECEIVED WITH RIGHT SIDE OF SPOON BROKEN OFF. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE HAD OCCURRED. RESULTS OF EVAULATION: BASED UPON INQUIRY INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT REPORTED INSTRUMENTS DISSECTION SPOON HAD BROKEN DURING SURGERY, MAKING INSTRUMENT NON FUNCTIONAL. INSTRUMENT WAS RECEIVED WITH RIGHT SIDE OF SPOON BROKEN AND PIECE WHICH HAD BROKEN OFF WAS RETURNED IN A SEPARATE BAG. THERE WAS EVIDENCE THAT INSTRUMENT WAS TORQUED DUE TO BEND IN COVER BETWEEN HANDLE AND TIP, SHAFT HOWEVER WAS STRAIGHT. SPOON THICKNESS, DESIGN, AND MATERIAL HAVE BEEN MODIFIED TO REDUCE OCCURRENCE OF THIS INCIDENT.
THE HOLDING SCREW BROKE AT THE THREADS DURING INSERTION OF THE NAIL. THE NAIL WAS THEN EXTRACTED, AND THE BROKEN THREADED PORTION WAS REMOVED. THE NAIL WAS THEN PLACED AND IMPLANTED BY HAND. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT DUE TO THIS EVENT. HOWEVER, THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY DUE TO EXTENSION OF SURGICAL TIME>30 MINS.
SUMMARY OF EVALUATION: THE EVALUATION SUGGEST THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE. THE CONDITION OF THE RETURNED GAMMA NAIL HOLDING SCREW WOULD SUGGEST IT WAS SUBJECTED TO NON-AXIAL FORCES, WHILE NOT BEING FIRMLY SECURED IN THE PROXIMAL THREADS OF THE GAMMA NAIL, CAUSING THE SCREW TO FRACTURE AT THE THREADED SECTION. TO PREVENT DAMAGING THE GAMMA NAIL PROXIMAL THREADS, AND SECOND, THE HOLDING SCREW MUST NOT BE IMPACTED DURING USE. DURING INSERTION OF THE GAMMA NAIL, IMPACTING IS PERFORMED TO THE HANDLE OF THE GAMMA NAIL IMPACTOR INSTRUMENT ONLY.
A REVISION SURGERY WAS PERFORMED TO EXTRACT AIR FROM THE SYSTEM. NO COMPONENTS WERE REMOVED OR REPLACED.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. LOST IMPLANT WAS 1 OR 6 PLACES. THE CLINICIAN USED OSTEOTOMES IN POSTERIOR MAXILLARY REGIONS DUE TO CLOSE SINUS PROXIMITY. BONE VOLUME & QUALITY IN AREA WAS NOT GOOD. A SOFT-RELINED MAXILLARY RPD WAS INSERTED 2 WKS POST-OPERATIVELY. THE CLINICIAN REPORTS MOBILITY OF IMPLANT (SITE #14) POSSIBLY DUE TO TRAUMA DURING HEALING.
DEVICE WAS APPLIED DURING A LAPAROSCOPY, HYSTEROSCOPY, LOA, RIGHT OVARIAN CYSTECTOMY, LEFT OVARIAN ENDOMETRIOSIS AND D&C. THE PROCEDURE WAS COMPLETE WITHOUT INCIDENT AND THE PT WAS DISCHARGED. 10/10/96 PT RETURNED WITH THE COMPLAINT THAT SHE WAS UNABLE TO VOID AND PASSING OUT. SHE WAS RE-ADMITTED. A HEMATOMA WAS NOTED AT THE UMBILICAL. AT 5:00PM THE PT WAS BROUGHT INTO THE O.R. WITH BLEEDING AT THE TROCAR SITE.
FEMALE PT WAS IMPLANTED WITH SPINE SYSTEM PRODUCT AT L2-L4 LEVELS ON 7/5/96. RECENTLY COMPLAINED OF PAIN. RETURNED FOR FOLLOW-UP VISIT ON 11/6/96 DURING WHICH X-RAY WAS TAKEN AND SHOWED BROKEN SCREW AT L4 LEVEL. REOPERATION PERFORMED FOR REMOVAL AND REPLACEMENT OF BROKEN SCREW ON 11/8/96. NO COMPLICATIONS REPORTED. PHYSICIAN UNABLE TO DETERMINE CAUSE OF SCREW FRACTURE; BELIEVES PLACEMENT/IMPLANTATION OF DEVICES WAS SATISFACTORY. MALFUNCTION IS OCCURRING BELOW THE FREQUENCY AND SEVERITY THAT ARE USUAL FOR THIS DEVICE.
11/14/96 - SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE CUFF WAS REMOVED FROM THE PT DUE TO EROSION AT BLADDER NECK, DAY NOT PROVIDED.
THE REPORTER INDICATED THAT THEY FOUND THE FOLLOWING DURING A FOLLOW-UP. THE RESPONSIBLE DOCTOR WHO FOUND THIS SAID THAT THIS PHENOMENON OCCURS IN ALL DEVICES THAT HE HAS IMPLANTED (HE HAS IMPLANTED BETWEEN 30 AND 40 UNITS). THE LEAD CONFIGURATION IS PROGRAMMED BIPOLAR IN THE ATRIUM AND VENTRICLE. FURTHER EVENT DESCRIPTION IS ON PAGE 3 OF THIS FORM.
EXTENSIVE DETAILS ARE NEEDED REGARDING EVERY STEP PERFORMED; VIDEO TAPE PREFERRED.
REMOVAL OF ENDOSSEOUS IMPLANT. SIX IMPLANTS WERE PLACED IN CLASS III BONE DURING A COMPLEX PROCEDURE. IMPLANT IN SITE #8 WAS REMOVED 18 MONTHS POST-OP. THE CLINICIAN REPORTS THE PT WEARS A MAXILLARY DENTURE AND SMOKES AND DRINKS MORE THAN A SOCIAL AMOUNT.
THE INSERT WAS REVISED DUE TO POLYETHYLENE WEAR. THE PATELLA COMPONENT (CATALOG#6638-3-960) WAS ALSO REMOVED AT THIS TIME AND WAS NOT REPLACED.
EVAL SUMMARY: THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO DISCREPANCIES DURING MANUFACTURE. H4: DEVICE MANUFACTURED 10/23/86
ON 9/21/90 AN AUS DEVICE WAS IMPLANTED. IN NOV OF 1995 THE CUFF WAS REMOVED. ON 7/16/96 THE CUFF WAS REIMPLANTED AND A BALLOON IMPLANTED. CURRENT BALLOON LEFT IN PLACE DUE TO DIFFICULT REMOVAL.
THE BATTERY FELL OFF ITS MOUNTING AND HIT ONE OF THE SHORTER NURSES IN THE FACE. FORTUNATELY NO GREAT HARM WAS DONE.
THIS IS THE INITIAL REPORT OF THE FOREIGN REPORTER. THE FOREIGN REPORTER HAS ASSIGNED AN INVESTIGATOR AND WILL FORWARD A CLOSING OUT REPORT.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. TEN IMPLANTS WERE PLACED ON 3/8/96 AND SITE 14-15 WAS REMOVED DUE TO MOBILITY ON 7/31/96. BILATERAL URQ AND ULQ SINUS ELEVATIONS WERE COMPLETED USING HIP GRAFTS. THE CLINICIAN SUSPECTS THAT POSSIBLE BONE GRAFT FAILURE WAS THE CAUSE OF IMPLANT FAILURE ALTHOUGH THE GRAFT IN THE UPPER RIGHT QUADRANT (URQ) WAS FINE.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FALURE RATE ASSOCIATED WITH ITS IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
NON FUNCTIONING PORT IN AT LAST 1 YEAR. HAS ANOTHER CO'S CATHETER ON OTHER SIDE. NO OBVIOUS PROBLEM WITH PORT OF CATHETER AT REMOVAL.
IAB CATH ALARMED, BLOOD NOTICED IN HELIUM LINE, IAB PLACED IN STANDBY, IAB CATH REMOVED. A SECOND IAB CATH WAS INSERTED.
THE PT HAD URGENT SURGERY DUE TO MITRAL INSUFFICIENCY, CAUSED BY DETACHMENT OF THE PROSTHESIS FROM THE ENDOCARDIAC BASE. SURGERY CONFIRMED VALVULAR DEHISCENCE AND ENDOCARDITIS.
THIS SECTION WAS COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY.
THE ENTIRE DEVICE WAS REMOVED FORM THE PT AND REPLACED DUE TO URETHRAL EROSION.
PT HAD REPLACEMENT OF THE 1ST CARPAL METACARPAL JOINT IN THE RIGHT HAND WITH A SILICONE IMPLANT. BY DECEMBER OF 1983 THERE WAS SUSPICION OF REFLEX SYMPATHETIC DYSTROPHY AND BY JANUARY 1994 HAD FULL BLOWN RSD IN THE RIGHT HAND. PHYSICAL THERAPY FOLLOWED FOR MANY MONTHS AND TWO COURSES (JANUARY 9, 1984 AND MARCH 7, 1984) OF STELLATE GANGLION BLOCKS IN CONJUNCTION WITH RIGOROUS PHYSICIAL THERAPY. IN SPITE OF THERAPEUTIC INTERVENTIONS THE HAND SUFFERED END-STAGE RSD.
THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED PURSUANT TO 21 CFR, PART 803. THE REPORT TRANSMITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OR OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
DEVICES REMOVED DUE TO PAIN AND LOSSENING.
THIS REPORT IS BEING AMENDED TO INCLUDE THE EVALUATION. EVALUATION CODES FOR SECTION H6: 100-68 100-DEVICE MEETS OVERLAY SPECIFICATIONS. OTHER AFFECTED DIMENSIONS MEET SPECIFICATION. 68-NO EVIDENCE OF WEAR ON FEMORAL OR ARTICULATING SURFACE. CAUSE OF STANDING IS UNK.
DEVICE DISCARDED BY UF, NO EVAL POSSIBLE.
AFTER 40 HRS OF USE BLOOD WAS NOTICED IN THE TUBING. IAB WAS REMOVED AND ANOTHER WAS INSERTED. PT EXPIRED DUE TO REASONS UNRELATED TO THE IAB CATHETER.
H-11-ALL UNK INFO REQUESTED BUT NOT RECEIVED. H-11-SECTION F PROVIDED BY MFG.
THE PATELLA COMPONENT WAS REVISED FOR POLYETHYLENE WEAR. THE TIBIAL COMPONENT (C/N 6638-5-207) WAS ALSO REMOVED AT THIS TIME.
THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. THE INFO PROVIDED INDICATES THE WEAR WAS ON THE MEDIAL SIDE WHICH SUGGESTS THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH ALIGNMENT. THE MEDICAL OPINION SUGGESTS THAT THE WEAR IS NORMAL FOR THE IMPLANTATION TIME.
THE PUMP WAS REMOVED FROM THE PT, DUE TO RECURRING INCONTINENCE-PUMP VALVE STUCK AND UNABLE TO ACTIVATE, AND REPLACED.
THE PT HAD "URGENT SURGERY REQUIRED AFTER THROMBSIS OF VALVE, WHICH WAS REMOVED".
THIS SECTION WAS COMPLETED BY THE MFR. NO MEDWATCH REPORT WAS RECEIVED FROM THE USER FACILITY.
FOUR IMPLANTS WERE PLACED AS REPLACEMENTS FOR ANOTHER CO'S FAILED           IMPLANTS. THE IMPLANT IN SITE #7 WAS REMOVED.
THE HOSPITAL REPORTED THAT THE EQUIPMENT WAS INVOLVED WITH A CORNEAL BURN ABOUT A MONTH AGO. THE DR INDICATED THAT HE BELIEVES THE BURN WAS HIS ERROR AND NOT THE MACHINE BUT WOULD LIKE TO HAVE THE MACHINE EVALUATED ANYWAY. THE PT REQUIRED UNANTICIPATED ADDITIONAL SUTURES.
INFO IN BLOCK F WAS COMPLETED BY THE MFR. H6,140,207,53-COMPONENT WEAR WAS OBSERVED AND REQUIRED REPLACEMENT AS A PART OF THE PREVENTATIVE MAINTENANCE. MECHANICAL AND FUNCTIONAL TESTS WERE PERFORMED ON THE MACHINE AND THE MACHINE WAS FOUND TO BE FUNCTIONING WITHIN ITS SPECIFICATION. COMPONENT WEAR WAS DETECTED DURING A PREVENTATIVE MAINTENANCE CHECK ON THE MACHINE AND THE ITEMS WERE REPLACED. THIS COMPONENT WEAR WAS NOT RELATED TO THE EVENT.
CNA SAT IN LIFT AFTER MOVING PT BECAUSE IT HAD MADE A STRANGE NOISE, TO CHECK FOR SAFETY. WHEN THE CNA SAT IN THE LIFT AND ANOTHER CNA BEGAN TO OPERATE THE LIFT, THE LIFT CRASHED TO THE FLOOR. NO PT INVOLVED. THE CNA SUFFERED PAIN TO BACK BUT IT IS NOT RESTRICTING AT THIS TIME. ONE PERSON INVOLVED.
CAUSE OF EVENT WAS 4 SET SCREWS WHICH CAME UNDONE FROM OUTER SHAFT. ASSEMBLY PROCEDURES HAVE BEEN CHECKED. TECHNICAL BULLETIN KM004 FROM THE UK EXPLAINS ACTIONS TO CORRECT PROBLEM. USER ERROR, THE MAINTENANCE MANUAL STATES: "CHECK THAT ALL SCREWS AND NUTS ARE TIGHTENED AND THAT THERE ARE NO GAPS ANYWHERE." CUSTOMER HAS BEEN INSTRUCTED TO REFER TO THE MAINTENANCE MANUAL FOR PROPER MAINTENANCE. IF THE CUSTOMER DOES NOT HAVE THE MANUAL THEY ARE TO REQUEST ONE.
THE BALLOON WAS REMOVED FROM THE PT, DUE TO FLUID LOSS AND RECURRING INCONTINENCE, AND REPLACED.
PT IS STARTING TO HAVE PROBLEMS; HOWEVER, NO SPECIFICS WAS GIVEN.
24WK MALE, PRECIPITOUS DELIVERY, EXTREMELY PRETERM, PLACED IN WARMER WITH FEW SPONTANEOUS MOVEMENTS. APGAR SCORES 3 AND 6 AT ONE AND FIVE MINUTES. PT RECEIVED A PRIMARY WOUND DSG ON ABD AND BACK FOR SKIN BREAKDOWN. UPON REMOVAL OF ABDOMINAL DSG, DESPITE MOISTENING SALINE THE SKIN PEELED OFF WITH THE DSG. HAS RECEIVED SUBSEQUENT IMMEDIATE AND ONGOING TREATMENT FOR THIS AND HAS SHOWN IMPROVEMENT.
PURSUANT TO INFO RECEIVED FROM THE PHYSICIAN, THE PT WAS IMPLANTED WITH A DEVICE WITH REMOTE INJECTION SITE ON 12/1/95. SUBSEQUENTLY, THE PHYSICIAN NOTED EXTRUSION AND NECROSIS OF THE PROSTHESIS. NO ADD'L INFO REGARDING THIS OCCURRENCE THE PHYSICIAN NOTED IS AVAILABLE AT THIS TIME.
ADD'L INFO TO BE SUBMITTED Y/N? Y. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (MENTOR EFFECTIVE DATE, 2/10/92). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENT IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21CFR803. "SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY CO EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B), (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION".
THE PT DIED FOLLOWING "ACUTE INSUFFICIENCY OF THE MITRAL VALVE CAUSED BY DISPLACEMENT OF THE VALVULAR DISK WITH A PARTIAL DETACHMENT OF ONE OF THE METAL BRACKETS OF THE MECHANICAL VALVE."
THE INFO CONTAINED HEREIN DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR SYSTEM THAT IS THE SUBJECT HEREOF MALFUNCTIONED OT THAT IT CAUSED OR CONTRIBUTED TO A DEATH OR INJURY. THIS DOCUMENT IS IN NO WAY TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OR AN ADMISSION AGAINT THE INTEREST OF DEPUY INC. OR ITS AFFILIATES.
THE FIXATOR WAS ORIGINALLY APPLIED TO TREAT A DISTAL RADIUS FRACTURE. THE DISTAL CLAMP HAD LOOSENED. THE FIXATOR WAS REMOVED AND THE PT PLACED IN A PLASTER CAST.
MD-APPLIED FIXATOR TO TREAT A FEMORAL FRACTURE. APPROX THREE DAYS LATER MD NOTED THAT THE SERRATED JOINT APPEARED TO HAVE SLIPPED. IT WAS RETIGHTENED IN THE OFFICE. ONE WEEK LATER A SECOND SURGERY WAS PERFORMED TO REPLACE THE FIXATOR AND REALIGN THE FRACTURE DUE TO A SECOND INCIDENT OF SLIPPAGE.
PLAINTIFF RPORTS INITIAL BILATERAL IMPLANTATION 4/29/83. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL RPTR. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MFG, OR SOLD BREAST IMPLANTS. ANOTHER CO CEASED MFG AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CO IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
MD APPLIED FIXATOR TO TREAT A FEMORAL FRACTURE. SOME ANGULATION OF THE FRACTURE WAS SUBSEQUENTLY NOTED. THE MD READJUSTED THE FRACTURE AND RETIGHTENED THE LOCKING SET SCREW.
THE PT WAS USING THE INFANT FLOW SYSTEM AS PART OF THE RESPIRATORY SYSTEM, AND DEVELOPED A PRESSUE INJURY TO THE NASAL SEPTUM /NARES.
DEVICE HAS NOT BEEN RETURNED FOR EVAL. AN EXAM MAY OR MAY NOT OCCUR IN THE FUTURE.
RECEIVED NOTIFICATION 10/11/96, OF A PENDING LAWSUIT. ALLEGING THAT HE NEGLIGENTLY APPLIED A STAPLING DEVICE ACROSS THE RIGHT URETER. PT REQURIED REOPERATION AND TREATMENT FOR INFECTION. IT DOES NOT APPEAR THAT THE DEVICE CONTRIBUTED TO THE INJURY. NO INDICATION OF CO BEING ADDED AS A DEFENDANT IN THIS LAWSUIT.
D5,6; H3,4,6; G4:ADDED ADDITIONAL INFO, INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. TWO IMPLANTS WERE PLACED IN SITES #22 AND #27 DURING A COMPLEX PROCEDURE IN CLASS II BONE. THE IMPLANTS WERE TIPPED TO AVOID ADJACENT EXTRACTION SOCKETS. THE PT WORE A DENTURE WHICH WAS LINED AND RELIEVED SUFFICIENTLY. THE IMPLANTS WERE LOOSE AND WERE REMOVED 3 MONTHS POST-OPERATIVELY.
PRODUCT IS PRIMARY WOUND DRESSING PACKAGE 1EA PER POUCH. FOLLOW-UP WITH REPORTER VERIFIED PRODUCT REMAINED IN PT FOR 5 DAYS & OUTER PLASTIC FILM WAS NOT REMOVED PRIOR TO WETTING WITH SALINE FOR REMOVAL. THE DIRECTIONS FOR USE STATE TO REMOVE BOTH FILM COVERING FOR SEMI-PERMEABLE DRESSING; ENSURE DRESSING & WOUND BED REMAIN MOIST; AND DRESSING CHANGE DICTATED BY AMT OF EXUDATE & VARIES FROM 1 TO 3 DAYS.
THE FIXATOR WAS ORIGINALLY APPLIED 9/96. ON 10/15/96 A SUPPLEMENTAL SCREW CLAMP WAS ADDED DUE TO A RADIAL/ULNAR DEFICIT. ON 11/01/96, WHILE AT HOME, THE PT HEARD A "POP" AND NOTED THAT ONE OF THE BONE SCREWS HAD BROKEN AT THE SKIN LINE. ON 11/4/96 THE MD REMOVED THE SCREW FRAGMENT AND THE SUPPLEMENTAL CLAMP.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 4/10/74. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY MFR AS DESCRIBED IN INFO PROVIDED BY INITIAL RPTR. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. MFR NEVER DESIGNED, MFR, OR SOLD BREAST IMPLANTS. ANOTHER CO CEASED MFG AND SELLING OF BREAST IMPLANTS IN 1984. MFR'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CO IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
A PT INFUSED 5 FLUOROURACIL AT 5ML/HR INSTEAD OF 0.5ML/HR. THE CUSTOMER INADVERTENTLY USED A 5ML/HR INFUSOR INSTEAD OF THE INTENDED 0.5 ML/HR INFUSOR. THE REPORT STATED THE PT WAS "WARDED IN THE ICU AND THE CONDITIONS WERE STABILIZED." NO FURTHER PT INFO AVAILABLE.
SECTION F WAS COMPLETED BY CO BASED ON INFO OBTAINED FROM THE CUSTOMER. THE RETURNED SAMPOES CONFIRMED THE CUSTOMER USED A 5ML/HR INFUSOR INSTEAD OF THE INTENDED 0.5ML/HR.
NEEDLE BREAKAGE OCCURRED DURING SURGERY. MDR REGULATIONS 7/31/96, REQUIRED REPORTING WHEN THE SAME DEVICE FAMILY AND NATURE OF EVENT WAS PREVIOUSLY DETERMINED TO BE A REPORTABLE EVENT.
H-6: BOTH RETURNED BROKEN NEEDLES WERE EVALUATED BY SCANNING ELECTRON MICROSCOPE. IT WAS CONCLUDED THAT THE NEEDLE FRACTURED IN A DUCTILE MANNER DUE TO TENSILE OVERLOAD IN THE PRESENCE OF A SHARP NOTCH. THE NEEDLE  FRACTURED IN A REDUCED CROSS SECTION, WHEN CRIMPED BY THE SURGICAL NEEDLE  HOLDERS. NEITHER NEEDLE SHOWED SIGNS OF MATERIAL OR MANUFACTURING DEFECTS AND THERE WAS NOT PRODUCT MALFUNCTION.
PT PULLED ON FOLEY CATHETER AND THE CATHETER RIPPED IN HALF, LEAVING PART IN BLADDER.
THREE IMPLANTS WERE PLACED IN CLASS II BONE DURING ROUTINE SURGERY IN SITES #18, #19, AND #20. THE IMPLANTS WERE REMOVED WITHIN 3 MONTHS FOLLOWING A POST-OP INFECTION.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF THE ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS IMPLANT IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
IMPLANTATION OF THE LEFT IMPLANT WAS 9/26/82 WITH EXPLANT 7/21/95: ATTY'S OFFICE ALLEGES CAPSULAR CONTRACTURE.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL RPTR. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MFG, OR SOLD BREAST IMPLANTS. ANOTHER CO CEASED MFG AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CO IN 1986. F10: LABELING-RECEIVED POWER LITIGATION.
THE PT WAS USING THE INFANT FLOW NASAL CANNULA AS PART OF THE RESPIRATORY SYSTEM, AND DEVELOPED A PRESSURE INJURY TO THE NASAL SEPTUM/NARES.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES NO J STIFFENER WIRE DISCREPANCIES. X-RAY OF LEAD DISTALLY CONFIRMS NO J STIFFENER WIRE DISCREPANCIES.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 5/4/76 WITH REPLACEMENT 3/29/77. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY CO HEALTHCARE AS DESCRIBED IN INFO PROVIDED BY INITIAL RPTR. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MFG, OR SOLD BREAST IMPLANTS. ANOTHER CO CEASED MFG AND SELLING OF BREASTS IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CO IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
ON 10/16/96, THE PHYSICIAN CONTACTED A MFR REP AND STATED THAT HE HAS EXPERIENCED PERISPINOUS ABCESS WITH THREE OF HIS PTS. THE PHYSICIAN INQUIRED WHETHER THESE INCIDENTS ARE RELATED TO THE DEVICE CATHETER AND WHETHER THIS TYPE OF INCIDENT HAS BEEN SEEN BEFORE. THIS REPORT INVESTIGATES THE FIRST INCIDENT.
A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS DEVICE, AS WELL AS THE DEVICE CATHETER, AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THESE CATALOG NUMBERS AND HAS NOT IDENTIFIED ANY TRENDS. THE DEVICE REMAINS IMPLANTED OR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN AT THIS TIME. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFORMATION AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE FACILITY WILL BE NOTIFIED OF OUR REVIEW OF THIS INCIDENT. NO FURTHER INFORMATION IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT. THE CORRECT EXPIRATION DATE OF THIS DEVICE IS 1/3/99.
THIS EVENT WAS REPORTED AS TWO TORN LEAFLETS, CALCIFIED ANNULUS RESULTING IN AN INSUFFICIENT VALVE. NO FURTHER INFO PROVIDED.
EVENT DOES NOT MEET CRITERIA OF A REPORTABLE EVENT AS DEFINED IN REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF EVENT RECURS. THE CATH IS A ONE-PIEC DESIGN W/NO BONDED AREAS AND IS FORMED BY MULTIPLE LAYERS OF LATEX WHICH CREATES A STRONG, STURDY SHAFT CAPABLE OF WITHSTANDING A MINIM 60 LBS. PULL FORCE. CONTINUOUS STRETCHING, PULLING CAN RESULT IN BREAKAGE AND IS USUALLY AIDED BY A SHARP OBJECT. EVALUATION BASED ON PROD. KNOWLEDGE AND HISTORY.
THE INFO RECEIVED FROM THE DISTRIBUTOR STATED: "THY HAD TO REMOVE THE PORT, BECAUSE THE CATHETER WAS BROKEN 12 CM FAR FROM THE PROXIMAL PART. PLACE OF BREAKAGE UNDER THE COLLARBONE".
H6 CODE 68-A CAUTION CONCERNING CATHETER SHEARING AS A RESULT OF VERY MEDIAL INSERTION OF THE CATHETER INTO THE SUBCLAVIAN VEIN IS CALLED OUT IN THE INSTRUCTIONS FOR USE (PACKAGE INSERT). SUCH INSERTION CAN CONTRIBUTE TO ANATOMICAL PINCHING OF THE CATHETER IN THE COSTOCLAVICULAR AREA LEADING TO COMPRESSIVE FRACTURE OF THE CATHETER. THE MDR IS REQUIRED BY THE FDA UNDER 21CFR PARA 803. THIS REPORT IS BASED ENTIRELY ON INFO REPORTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK PACEMAKER CORP DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOSU INJURY OCCURRED, THAT ANY COOK PACEMAKER CORP DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ANY COOK PACEMAKER CORP DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
PLAINTIFF REPORT INITIAL BILATERAL IMPLANTATION 10/22/81. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICIAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL RPTR. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MFG, OR SOLD BREAST IMPLANTS. ANOTHER CEASED MFG AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CO IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
CLIENT DEVELOPED PHLEBITIS BELOW INSERTION SITE OF PICC LINE. ATTEMPT TO FLUSH PICC INCREASED PAIN. UPON REMOVAL OF PICC LINE A HOLE WAS DISCOVERED ALLOWING CEFAZOLIN TO LEAK INTO SUBCUTANEOUS TISSUE. DURING ORIGINAL INSERTION STYLET REMOVAL WAS VERY DIFFICULT WHICH MAY BE RELATED TO CATHETER DEFECT.
THIS EVENT WAS REPORTED AD DEBRIDEMENT OF SUB VALVULAR ABSCESS AND CLOSURE OF VSD. NO FURTHER INFO PROVIDED.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
PLAINTIFF REPORTS BILATERAL IMPLANTATION 6/2/80. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICAL PAIIN, INMPAIRMENT, AND SUFFERING.
IMPLANTATION OF THE RIGHT IMPLANT WAS 9/26/82 WITH EXPLANT 7/21/95. ATTORNEY'S OFFICES REPORTS THAT THE CONSUMER EXPERIENCED A RUPTURE.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MANUFACTURED, OR SOLD BREAST IMPLANTS. ANOTHER CO CEASED MANUFACTURE AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CORP. IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
PLAINTIFF REPORTS INITIAL BILATERAL 11/6/79 WITH REPLACEMENT 6/2/0. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICIAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL RPTR. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MFG, OR SOLD BREAST IMPLANTS. ANOTHER CO CEASED MFG AND SELLING OF BREAST IMPLANTS IN 1984. CO'S A RESULT OF ITS ACQUISITION OF ANOTHER CO IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. FAILURE ANALYSIS IS PROVIDED.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED-12MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 75MM AND HAS MIGRATED DOWN LEAD BODY 13MM PROXIMAL OF WELD SITE. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THAT THE PROXIMAL END OF THE 12MM SECTION OF J STIFFENER WIRE HAS ABRADED A HOLE IN THE OUTER POLYURETHANE INSULATION 12MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEARSUREMENTS ADDING UP TO 87MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURE.
ALLEGED INFECTION. FOLLOW-UP FINDINGS: AS PER PHYSICIAN, ETIOLOGY UNKNOWN.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY MCGHAN MEDICAL THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSCIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF CO'S EVALUATION OF THE DEVICE. CO'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. CO CONSIDERS THIS INFO TO BE HIGHLY CONFIDENTIAL AND, THEREFORE, REQUESTS PROTECTION FROM ANY REQUEST, PURSUANT TO 21 CFR PART 803.9 (B). DEVICE EVALUATION METHOD CODE 86 = DEVICE WAS NOT RETURNED FOR EVALUATION. F. FOR USE BY USER FACILITY/DISTRIBUTOR - "DEVICES ONLY" SECTION INFO IS TO BE PROVIDED BY A USER FACILITY OR DISTRIBUTOR. THE REPORT SOURCE FOR THIS EVENT WAS NOT A USER FACILITY OR DISTRIBUTOR. THE "F" SECTION INFO IS THEREFORE UNAVAILABLE.
MFR COMPLETED SECTION D6,D7,D8. THE REPORTER HAD STATED THAT PRIOR TO INSERTING THE PICC LINE IN THE PT, DIFFICULTY IN REMOVING THE STYLET HAD BEEN EXPERIENCED. AFTER FLUSHING THE CATHETER THE STYLET WAS REMOVED AND THE CATHETER TRIMMED. NO LEAKAGE WAS OBSERVED WHILE FLUSHING THE CATHETER. THE PICC LINE WAS THEN INSERTED INTO THE PT AND AGAIN DIFFICULTY REMOVING THE STYLET WAS EXPERIENCED. TWO DAYS LATER THE PT COMPLAINED OF DISCOMFORT BELOW THE INSERTION SITE. THE PICC LINE WAS PULLED BACK SEVERAL INCHES AND A HOLE WAS NOTED IN THE CATHETER. THERE WAS NO PUFFINESS AT THE SITE. NAFCILLIN WAS BEING INFUSED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED. THE CATHETER WAS RETURNED WITHOUT THE STYLET. THE CATHETER WAS TESTED AND FOUND TO BE PATENT. LEAKAGE WAS NOTED FROM A SMALL HOLE AT THE 45.5 CM MARKING ON THE CATHETER. MICROSCOPY EXAM SHOWED A BLACK STREAK IN THE VICINITY OF THE HOLE. THE BLACK LINE IS CONSISTENT WITH DAMAGE INCURRED DURING THE PRINTING PROCESS.
THE INFO RECEIVED FROM THE DISTRIBUTOR STATED: "THE PORT HAS BEEN REMOVED BECAUSE DURING THE THERAPY THEY FOUND OUT THAT THE CATHETER WAS BROKEN IN THE POINT WHERE THE CATHETER GO THROUGH THE COLLARBONE AND THE FIRST RIB."
H6 CODE 68-A CAUTION CONCERNING CATHETER SHEARING AS A RESULT OF VERY MEDIAL INSERTION OF THE CATHETER INTO THE SUBCLAVIAN VEIN IS CALLED OUT IN THE INSTRUCTIONS FOR USE (PACKAGE INSERT). SUCH INSERTION CAN CONTRIBUTE  TO ANATOMICAL PINCHING OF THE CATHETER IN THE COSTOCLAVICULAR AREA LEADING TO COMPRESSIVE FRACTURE OF THE CATHETER. THE MDR IS REQUIRED BY THE FDA UNDER 21 CFR PARA. 803. THIS REPORT IS BASED ENTIRELY ON INFO REPORTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATMENT IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK PACEMAKER THAT ANY COOK PACEMAKER CORP. DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, THAT ANY COOK PACEMAKER CORP DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ANY COOK PACEMAKER CORP DEVICE WOLUD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION IN 1977. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICAL PAIN, IMPAIRMENT, AND SUFFERING.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED 37MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 51MM AND HAS MIGRATED DOWN LEAD BODY 40MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO 88MM. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES EPOXY RESIDUE ON SEPARATED BOND SURFACE TO DISTAL SIDE OF ANODE BAND. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURE.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED ~28MM, ~31MM, AND ~37MM, PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES ~51MM AND HAS MIGRATED DOWN LEAD BODY ~41MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO ~87MM. X-RAY OF LEAS DISTALLY CONFIRMS J STIFFENER WIRE FRACTURES.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 11/6/75. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICAL PAIN, IMPAIRMENT, AND SUFFERING.
ON 10/16/96, THE PHYSICIAN CONTACTED A MFR REP AND STATED THAT HE HAS EXPEREINECED PERISPINOUS ABCESS WITH THREE OF HIS PTS. THE PHYSICIAN INQUIRED WHETHER THESE INCIDENTS ARE RELATED TO DEVICE CATHETER AND WHETHER THIS TYPE OF INCIDENT HAS BEEN SEEN BEFORE. THE REPORT INVESTIGATES THE SECOND INCIDENT.
A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THIS DEVICE, AS WELL AS THE DEVICE CATHETER, AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THESE CATALOG NUMBERS AND HAS NOT IDENTIFIED ANY TRENDS. THE DEVICE REMAINS IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN AT THIS TIME. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFORMATION AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. THE FACILITY WILL BE NOTIFIED OF CO'S REVIEW OF THIS INCIDENT. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT. CORRECTED DATA: THIS DEVICE WAS ORIGINALLY REPORTED AS A IMPLANTABLE INFUSION PUMP, HOWEVER, SINCE THE INCIDENT WAS RELATED TO THE INSERTION SITE OF THE CATHETER, THE CATHETER SHOULD BE LISTED AS THE SUSPECT MEDICAL DEVICE. UNDER SECTION D1, THE DEVICE WAS REPORTED AS BEING AN INFUSAID IMPLANTABLE INFUSION PUMP. THE CORRECT BRAND NAME FOR THIS DEVICE IS INFUSAID EPIDURAL CATHETER KIT. UNDER SECTION D2 THE TYPE OF DEVICE WAS REPORTED AS AN IMPLANTABLE INFUSION PUMP. THE CORRECT TYPE OF DEVICE IS EPIDURAL CATHETER KIT. UNDER SECTION D5 THE EXPIRATION DATE WAS REPORTED AS 3/29/97. THE CORRECT EXPIRATION DATE FOR THIS DEVICE IS 1/3/99. UNDER SECTION D6 THIS DEVICE WAS REPORTED AS A MODEL 400, CATALOG #36263, SERIAL #32123. THE CORRECT DEVICE IS CATALOG #36633, LOT #11673. UNDER SECTION D10, CONCOMITANT MEDICAL PRODUCTS WAS LISTED AS NA. THE CORRECT CONCOMITANT MEDICAL PRODUCT IS THE INFUSAID IMPLANTABLE INFUSION PUMP, MODE #400, CATALOG #36263, SERIAL #32123, EXPIRATION DATE 3/29/97, IMPLANT DATE 3/9/96. NO FURTHER INFORMATION IS AVAILABLE.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 9/12/83. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICIAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MANUFACTURED, OR SOLD BREAST IMPLANTS. CORP CEASED MANUFACTURE AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CORP. IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
DURING A CONTRAST INJECTION (SECOND OF 2 INJECTIONS), THE PT DEVELOPED STROKE-LIKE SYMPTOMS. THE PT WAS TRANSFERRED TO THE HOSP FOR TREATMENT. ALTHOUGH NOT SEEN ON FILM, AIR EMBOLISMS SUSPECTED.
AFTER EMBOLISM REMAINS UNCOMFIRMED. AIR WAS NOT VISIBLE ON THE FILM BUT WAS VISIBLE IN THE TUBING FOLLOWING  THE PT'S REACTION. THE CURRENT CONDITION OF THE PT IS UNKNOWN. CO SVC REP CHECKED THE UNIT AND FOUND IT TO OPERATE PROPERLY. INJECTOR FUNCTIONED AND IS NOT IN QUESTION. FOLLOWING EQUIPMENT INSPECTION, THE SVC REP RE-TRAINED EQUIPMENT OPERATORS ON PROPER LOADING TECHNIQUE.
THE POTENTIAL FOR THE ABOVE-NOTED EVENT(S) TO OCCUR IS ADDRESSED AND/OR ANTICIPATED IN THE LABELING. AS PER 21 CFR, PART 803.16, THIS REPORT AND INFO DOES NOT NECESSARILY REFLECT A CONCLUSION BY CO THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, THE REPORTING ENTITY, OR ITS' EMPLOYEES, OR THE PHYSICIAN/USER CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. CO DOES NOT CONSIDER THAT THE ASSIGNMENT OF THE MEDWATCH EVALUATION CODES ARE, NECESSARILY, AN ACCURATE REFLECTION OF EVALUATION OF THE DEVICE. CO'S APPROACH TO MDR COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. CO CONSIDERS THIS INFO TO BE HIGHLY CONFIDENTIAL AND, THEREFORE, REQUEST THAT YOU PROTECT IT FROM ANY REQUEST, PURSUANT TO 21 CFR PART 803.9 (B). DEVICE EVALUATION METHOD CODE 86 = DEVICE WAS NOT RETURNED FOR EVALUATION. F. FOR USE BY USER FACILITY/DISTRIBUTOR - "DEVICES ONLY" SECTION INFO IS TO BE PROVIDED BY A USER FACILITY OR DISTRIBUTOR. THE REPORT SOURCE FOR THIS EVENT WAS NOT A USER FACILITY OR DISTRIBUTOR. THE "F" SECTION INFO IS THEREFORE UNAVAILABLE.
PT ALLEGES HAVING MANY HEALTH PRBLEMS AND DOES NOT KNOW WHETHER THE IMPLANT IS THE CAUSE OR NOT.
THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED PURSUANT TO 21 CFR, PART 803. THE REPORT TRANSMITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATION SHEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF THE DEVICE MALFUNCTION OR OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 6/9/77. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICIAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MANUFACTURED, OR SOLD BREAST IMPLANTS. CORP CEASED MANUFACTURE AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CORP IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
FLUID LEAKING FROM RECIP. BLADE MOUNT DURING AN ILIAC CREST. SAW WAS REMOVED FROM FIELD AND PT GIVEN ANTIBITICS. WOUND IRRIGATED AND DEBRIDED. OSTEOTOMES AND CURETTE USED TO FINISH GRAFT.
PLEASE NOTE THAT ALL INFO IN SECTIONS A,B,D,E, AND F WERE NOT PROVIDED BY THE USER FACILITY AND MFR IS PROVIDING THIS INFO BASED ON CASE INVESTIGATION. ANY INFO NOT PROVIDED IS UNKNOWN OR UNAVAILABLE TO THE USER FACILITY. EVALUATION SUMMARY: INSPECTION OF THIS DEVICE REVEALED EXTENSIVE CORROSION. THERE WAS NO EVIDENCE OF OIL LEAKAGE. SUSPECT THAT THE FLUID WAS IRRIGATION SOLUTION THAT MADE CONTACT WITH THE CORRODED AREA OF THE SAW AND WAS EXPELLED OUT THE FRONT OF THE DRILL. PASSED THIS EVAL TO SALES REP 10/25/96.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE LEAD WAS SNIPPED OR CUT INTO THREE SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE EITHER WAS CUT OR HAS FRACTURED 83MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 5MM AND IS LOCATED AT THE DISTAL END OF THE MEDIAL SECTION OF LEAD RECEIVED. IT APPEARS THAT ENTIRE J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED MEASUREMENTS ADDING UP TO 88MM. X-RAY OF LEAD CONFIRMS NO OTHER J STIFFENER WIRE FRACTURES.
PREVIOUSLY REPORTED AS EXPLANTED DUE TO A J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. DEVICE ANALYSIS CONFIRMED COMPLAINT. JUNE 1997 FLUOROSCOPY SCREENING WAS RE-EVALUATED BY THE PHYSICIAN. THE J RETENTION WIRE WAS REPORTED TO BE FRACTURED WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
THIS EVENT WAS REPORTED AS DEVICE EXPLANTED REASON UNK. NO FURTHER INFO PROVIDED.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 9/13/82. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICIAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MANUFACTURED, OR SOLD BREAST IMPLANTS. ANOTHER CORP CEASED MANUFACTURE AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF THE OTHER CORP IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
STATES " THE INITIAL ASSESSMENT REGARDING THE CAUSE OF DEATH IS THAT THE BLEED INTO THE RIGHT PLEURAL CAVITY WAS CAUSED BY A TEAR CAUSED BY THE INTRODUCER DURING REIMPLANT OF NEW LEADS."
PT EXPERIENCED "REDMAN SYNDROME" WHILE INFUSING 1.7 GM VANCOMYCIN IN 200ML NS. THE INFUSION TIME WAS REPORTED TO BE 1.5 HRS INSTEAD OF AN ANTICIPATED 2 HRS. THE PT RN SUBSEQUENTLY ACTIVATED THE SLIDE CLAMP TO SLOW THE INFUSION TIME.
SECTION F WAS COMPLETED BY BAXTER BASED ON INFO OBTAINED FROM THE CUSTOMER.
THIS EVENT WAS REPORTED AS 3-4+ MITRAL INSUFFICIENCY. NO FURTHER INFO PROVIDED.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 1/27/74. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICIAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MANUFACTURED, OR SOLD BREAST IMPLANTS. ANOTHER CORP CEASED MANUFACTURE AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CORP IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 8/21/78. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICIAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MANUFACTURED, OR SOLD BREAST IMPLANTS. ANOTHER CORP CEASED MANUFACTURE AND SELLING OF BREAST IMPLANTS IN 1984. CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CORP IN 1986. F10: LABELING-RECEIVING PER LITIGATION.
THE PORT WAS PLACED 10/30/95, ON THE LEFT SIDE AT ANOTHER FACILITY. IN 4/96, THE CATHETER WAS FOUND TO HAVE BROKEN OFF "AT THE INTERSECTION SITE" AND MIGRATED TO THE PULMONARY ARTERY. THE PT HAD BEEN RECEIVING ANTIBIOTICS AND ASPIRATION DIFFICULTIES HAD BEEN NOTED.
THE DEVICE WAS REMOVED 4/96. THE LOCATION OF THE DEVICE IS PRESENTLY UNKNOWN.
DURING A LAPAROSCOPIC TUBAL LIGATION THE R0708 WAS BEING INSERTED AND THE SAFETY SHIELD WAS SLOW TO COVER THE BLADE OF THE TROCAR. BEFORE THE BLADE WAS COVERED, IT CUT INTO THE OMENTUM AND NICKED A PORTION OF THE SMALL BOWEL. A GENERAL SURGEON WAS CONSULTED AND DETERMINED THAT IT DID NOT WARRANT OPENING THE PT. TWO DAYS POST-OPERATIVE THE PT'S CONDITION REQUIRED REOPERATION FOR SMALL BOWEL PERFORATION. THE DAMAGED PORTION OF THE BOWEL WAS RESECTED AT THAT TIME. THE TROCAR IS BEING RETAINED BY THE HOSP AT THIS TIME.
A1,2,4; B6,7; D10: INFO UNAVAILABLE. D5,6; H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. THE RETENTION WIRE WAS REMOVED AND THE LEAD BODY REMAINS IMPLANTED.
THIS ENTIRE FORM COMPLETED BY MFR. THE RETENTION WIRE ONLY REMOVED FROM LEAD. 84MM PORTION OF THE J STIFFENER WIRE WAS RECEIVED. FAILURE ANALYSIS INDICATES FRACTURE.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 8/21/75 WITH REPLACEMENT 8/21/78. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICIAL PAIN, IMPAIRMENT, AND SUFFERING.
SECTION F COMPLETED BY CO AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: RECEIVED PER LITIGATION. MULTIPLE DEFENDANTS ARE NAMED IN THE SUIT. CO NEVER DESIGNED, MANUFACTURED, OR SOLD BREAST IMPLANTS. ANOTHER CORP CEASED MANUFACTURE AND SELLING OF BREAST IMPLANTS IN 1984, CO'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF ANOTHER CORP IN 1986. F10: LABELING-RECEIVED PER LITIGATION.
THE PORT WAS PLACED 8/9/96, FOR INFUSION OF PANHEMATIN. A ROUTINE FLUSH WAS DONE ON 9/14/96. ON 9/28/96 THE PT FELT SOMETHING WAS WRONG AND CALLED THE DR. AN X-RAY WAS DONE WHICH SHOWED THE CATHETER HAD BROKEN OFF AND EMBOLIZED TO THE PULMONARY ARTERY.
THE PORT WAS REMOVED AND REPLACED. THE LOCATION OF THE PORT IS CURRENTLY UNKNOWN.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 4/3/82. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICIAL PAIN, IMPAIRMENT, AND SUFFERING.
ON 10/16/96, THE PHYSICIAN CONTACTED A MFR REP AND STATED THAT HE HAS EXPERIENCED PERISPINOUS ABSCESS WITH THREE OF HIS PTS. THE PHYSICIAN INQUIRED WHETHER THESE INCIDENTS ARE RELATED TO THE DEVICE CATHETER AND WHETHER THIS TYPE OF INCIDENT HAS BEEN SEEN BEFORE. THIS REPORT INVESTIGATES THE THIRD INCIDENT.
A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THIS DEVICE, AS WELL AS THE DEVICE CATHETER, AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THESE CATALOG NUMBERS AND HAS NOT IDENTIFIED ANY TRENDS. THE DEVICE REMAINS IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN AT THIS TIME. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE FACILITY WILL BE NOTIFIED OF CO'S REVIEW OF THIS INCIDENT. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT. UNDER SECTION D5 THE EXPIRATION DATE WAS REPORTED AS 4/12/97. THE CORRECT EXPIRATION DATE FOR THIS DEVICE IS 1/3/99.
PLAINTIFF REPORTS INITIAL BILATERAL IMPLANTATION 3/29/77 EXPLANT ON 10/17/83. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PHYSICIAL PAIN, IMPAIRMENT, AND SUFFERING.
THIS ENTIRE FORM COMPLETED BY MFR. UNABLE TO PERFORM ANALYSIS ELECTRODE DAMAGED. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES NO J STIFFENER WIRE FRACTURES. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE OUTER POLYURETHANE INSULATION WAS LACERATED 3CM, 3.5CM AND 6CM PROXIMAL OF FIXATION HELIX HOUSING ELECTRODE TIP. VISUAL INSPECTION UNDER 30X MAGNIFICATION ALSO INDICATES THE LEAD WAS SNIPPED OR CUT INTO TWO SECTIONS, WITH EVIDENCE OF FLARED COIL WIRE ENDS. X-RAY OF LEAD DISTALLY CONFIRMS NO J STIFFENER WIRE FRACTURES.
APPROX 3-5 DAYS AFTER THE CATHETER WAS REMOVED, THE PT DEVELOPED A CLOT AND DIED OF A BOWEL OBSTRUCTION, THE DR COULD SEE NOTHING VISIBLY WRONG WITH THE CATHETER. THE CLOT CONTINUED TO GROW IN THE PT EVENT THOUGH THE CATHETER HAD BEEN REMOVED.
THE PHYSICIAN AT THE TREATING FACILITY STATED THAT THE CATHETER HAD BEEN REMOVED AND DISCARDED, SO IT WAS UNAVAILABLE FOR EVAL. A DEVICE HISTORY REVIEW WAS NOT POSSIBLE AS THE DR INDICATED THAT THE LOT NUMBER WAS UNKNOWN.
ON 10/1/96, DURING INFUSION, IT WAS REPORTED TAHT THE NEEDLE BECAME DISLODGED FORM THE PORT AND EXTRAVASTATION OF DACARBAZINE WAS REPORTED. THE PORT REMAINS IN THE PT AND NO INJURY WAS REPORTED.
NO EVAL OF THE DEVICE IS POSSIBLE AS IT REMAINS IMPLANTED IN THE PT. A REVIEW OF THE LOT HISTORY INDICATED NO RELATED MFR ISSUES, AND NO OTHER PRODUCT COMPLAINTS WERE REPORTED FOR THIS LOT.
THE DEVICE WAS IMPLANTED ON 8/20/96 FOR ARTERIAL INFUSION OF FUDR FOR TREATMENT OF CANCER. ON 10/25/96, THE FACILITY NURSE CONTACTED A MFR NURSE AND REPORTED THAT THE DEVICE REFILLS ARE BEING PERFORMED AT ANOTHER FACILITY. ON 10/24/96 THE DEVICE WAS REFILLED WITH HEPARINIZED SALINE. THE NURSE PERFORMING THE REFILL HAD SOME DIFFICULTY ACCESSING THE DEVICE CENTER SEPTUM. ONLY ONE ATTEMPT WAS PERFORMED. THE PT AWOKE THE FOLLOWING MORNING AND NOTICED A "FLUID COLLECTION" AROUND THE DEVICE WHICH WAS NOT THERE WHEN HE WENT TO BED. THE PT CONTACTED THE FACILITY NURSE AS WELL AS HIS IMPLANTING PHYSICIAN AND WAS SEEN BY THE IMPLANTING PHYSICIAN ON 10/25/96. THE MFR NURSE ASKED THE FACILITY NURSE IF THE PT HAD BUMPED THE DEVICE; HOWEVER, THE PT WAS NOT AWARE OF ANY TRAUMA TO THE DEVICE AREA. THE FACILITY NURSE STATED THAT THERE WAS NO EVIDENCE OF A HEMATOMA AROUND THE DEVICE POCKET ON 10/25/96. THE MFR NURSE THEN INQUIRED IF THE REFILL NURSE HAD FOLLOWED THE MFR'S REFILL PROCEDURE; HOWEVER, THE FACILITY NURSE WAS NOT SURE IF THE MFR'S REFILL PROCEDURE HAD BEEN FOLLOWED. THE MFR NURSE THEN RECOMMENDED THAT THE DEVICE BE EMPTIED TO DETERMINE VOLUMES INFUSED AND RESERVOIR VOLUME.
ON 10/30/96, THE IMPLANTING PHYSICIAN CONFIRMED THAT THERE IS NO EVIDENCE OF A DEVICE POCKET INFECTION FROM THE ASPIRATE WHICH HAD BEEN CULTURED FROM THE DEVICE POCKET. ON 10/31/96, THE MFR NURSE CONTACTED THE NURSE WHO HAD PERFORMED THE DEVICE REFILL TO OBTAIN ADD'L INFO CONCERNING THIS EVENT. THE REFILL NURSE STATED THAT SHE HAD ACCESSED THE DEVICE ON 10/28/96 AND THE VOLUME INFUSED VS THE VOLUME OF THE DEVICE RESERVOIR AT THE TIME OF THE LAST REFILL ON 10/24/96 WAS ACCURATE. THERE WERE NO VOLUME DISCREPANCIES. THE REFILL NURSE ALSO STATED THAT THERE WAS NO HEMATOMA ON THE DEVICE POCKET ON 10/24/96; HOWEVER, THERE WAS A SMALL AMOUNT OF OLD GREEN-YELLOW BRUISING ABOUT A "QUARTER SIZE" NOTED ON THE DEVICE POCKET ON 10/28/96. THE PT DID NOT COMMENT THAT THE DEVICE POCKET LOOKED OR FELT WORSE AT THAT TIME. THE REFILL NURSE THEN STATED THAT THE PT'S DEVICE IS USUALLY EASY TO ACCESS; HOWEVER, SHE MISSED ON HER FIRST TRY ON 10/24/96. INSTEAD OF WITHDRAWING THE NEEDLE COMPLETELY, THE REFILL NURSE STATED THAT SHE REPOSITIONED THE NEEDLE AND "WALKED IT OVER" TO THE DEVICE CENTER SEPTUM, IN ADDITION, THE REFILL NURSE STATED THAT IT TOOK ONLY ONE TRY TO ACCESS THE DEVICE AND THAT SHE FOLLOWED THE MFR'S REFILL PROCEDURE USING A MFR 22 GAUGE NEEDLE. THE DEVICE PORT WAS NOT ACCESSED. ON 11/7/96, THE MFR NURSE CONTACTED THE REFILL NURSE TO OBTAIN FOLLOW UP INFO. THE NURSE STATED THAT THE PT HAD BEEN IN THE OFFICE ON 11/4/96 AND THE DEVICE POCKET WAS EXAMINED AT THE TIME. THE NURSE STATED THAT THE SEROMA AND BRUISING HAD BEEN RESOLVED AND THERE WERE NO FURTHER COMPLAINTS ABOUT THE DEVICE POCKET FROM THE PT. THE DEVICE IS FUNCTIONING AS INTENDED AND WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PT'S THERAPY REGIMEN. BASED ON THE AVAILABLE INFO, THIS EVENT APPEARS TO HAVE BEEN THE RESULT OF PROCEDURAL/TECHNIQUE RELATED FACTORS AND WAS NOT DUE TO A DEVICE MALFUNCTION OR FAILURE. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
PT EXPERIENCED LEFT KNEE PAIN. REVISION SURGERY FOUND DELAMINATION OF U H M W P E ON TIBIAL INSERT'S ARTICULATING SURFACE.
H6. EVALUATON CODE METHOD -CO HAS BEEN NOTIFIED THAT THE REVISED TIBIAL INSERT IS NOT AVAILABLE FOR ANALYSIS.
REVISION SURGERY-HEAD DISASSOCIATED FROM LINER. UNDETERMINED WHAT HAPPENED.
SECTION F SALES AGENT PROVIDED HOSPITAL. LOOKED UP ADDRESS/PHONE NUMBER ON THE INTERNET. HOSPITAL PERSONEL PROVIDED RISK MANAGEMENT/MEDWATCH REPORTING DEPARTMENT. CALLLED AND NO ADDITIONAL INFORMATION COULD BE PROVIDED. H6, METHOD 86 OTHER - DEVICE HISTORY REVIEWED. H6, RESULTS 100 AND 300 OTHER - DEVICE WAS TO DAMAGED TO YIELD ANY RESULTS. H6, CONCLUSION 68 OTHER - INSUFFICIENT INFORMATION EXIST TO DETERMINE THE CAUSE OF THE DISLOCATION.
AFTER EVALUATING WALKER IT IS DETERMINED THAT USER WAS WALKING, LOST BALANCE AND FELL ON WALKER.
H6. METHOD 86-OTHER (DIMENSIONAL AND MICROSCOPIC EVAL PERFORMED) H6. CONCLUSIONS 68. OTHER. (DEVICE FAILURE APPEARS TO BE OVER STRESSED INSERT LOCKING TAB RELATED TO ALLGNMENT).
IMPLANT PLACED 11/15/95. IMPLANT DIDN'T ADAPT TO SURGICAL SITE. DATE OF OCCURRENCE UNK. ONE PERSON AFFECTED.
REVISION SURGERY-LINER DISASSOCIATED FROM SHELL. UNDETERMINED WHAT HAPPENED.
COULD NOT PIERCE ADAPTER WITH BLUNT CANNULA (PIECE OF THE ADAPTER FIRING INSIDE OF THE PREPIERCED RESEAL).
IMPLANT PLACED 6/12/96. SITE TURNED OUT TO BE TOO BIG FOR IMPLANT. DATE OF OCCURRENCE IS UNK. ONE PERSON AFFECTED.
AS THE LOT NUMBER WAS UNK, A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. INFO RECEIVED FROM THE DR. OFFICE INDICATES THAT THE SITE TURNED OUT TO BE TOO LARGE FOR THE IMPLANT. CO HAS BEEN UNABLE TO FIND OUT WHETHER THE IMPLANT WAS REMOVED IN FAVOR OF A WIDER ONE IMMEDIATELY, OR WHETHER THE IMPLANT WAS LEFT IN THE SITE FOR A TIME. AS SUCH, THIS EVENT IS BEING TREATED AS REPORTABLE.
WHEN PREPARING THE ROD FOR INSERTION INTO THE TIBIA, DR WAS TIGHTENING THE JIG INTO THE ROD. THE END OF THE JIG SNAPPED OFF INTO THE PROXIMAL END OF THE ROD. UNABLE TO RETRIEVE BROKEN END OF JIG OUT OF ROD. DR SELECTED ANOTHER SIZE ROD AND INSERTED IT WITHOUT THE JIG USING ANOTHER TOOL.
PT ALLEGES SHE HAS HAD NINE SURGERIES BECAUSE THE IMPLANTS WERE "INFECTED OR RUPTURED" AND STATES SHE HAS PAIN. PHYSICIAN ALLEGES PT SUFFERS FROM SILICONE-RELATED ATYPICAL CONNECTIVE TISSUE DISEASE, WITH THE FOLLOWING DIAGNOSTIC SYMPTOMS: JOINT PAIN, FATIGUE, SICCA SYMPTOMS, RAYNAUD'S, BURNING PAIN AND DISFIGUREMENT OF BOTH BREASTS, IRITABLE BOWEL AND OBJECTIVE NEUROPSYCHIATRIC.
CONCLUSION: 68A NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN. THIS STATEMENT IS ATTACHED TO THIS REPORT AND IS SUBMITTED PURSUANT TO 21 CFR, PART 803. THE REPORT TRANSMITS ALLEGATIONS AND THERE IS NO BASIS FOR ASSUMING THE VALIDITY OR INVALIDITY, SCIENTIFIC OR OTHERWISE, OF THE ALLEGATIONS HEREIN. NONE OF THE INFO IN THIS REPORT CAN BE CONSTRUED AS AN ADMISSION OF A DEVICE MALFUNCTION OR OF ANY CAUSAL CONNECTION BETWEEN A PRODUCT AND ANY ALLEGED INJURY.
DURING VITRECTOMY SURGERY OF LEFT EYE TWO (2) PIECES OF METAL SHAVINGS WERE VISIBLE WITHIN EYE. MAGNET UTILIZED TO REMOVE METAL. NO HARM TO PT EXPECTED.
IMPLANT WAS PLACED 3/19/96 AND REMOVED 10/23/96. ONE PERSON AFFECTED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. NO MEDICAL HISTORY, WHICH CAN INDICATED WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
PT PULLED OUT HIS INDWELLING FOLEY CATHETER. CATHETER BROKE, LEAVING APPROX 10-12" IN THE PT'S URETHRA. THE PHYSICIAN WAS ABLE TO MANIPULATE THE PENIS WITH REMOVED THE REMAINING PIECE.
IMPLANT PLACED IN MANDIBLE 8/13/96. IT WAS REMOVED 10/11/96. ONE PERSON AFFECTED.
AS THE LOT NUMBER WAS UNK, A REVIEW OF THE DEVICE HISTORY COULD NOT BE CONDUCTED. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE CAUSE OF FAILURE.
DR REPORTED THAT AN ABUTMENT BROKE IN FUNCTION.  PT IS REPORTEDLY FINE. PT IS SAME PT AS PRIOR MDR REPORT M751728.
PT ALLEGES IN 1992 HER IMPLANT BROKE/RUPTURED.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. ACCURATE MEASUREMENTS COULD NOT BE TAKEN DUE TO THE DAMAGED CONDITION OF THE COMPONENT. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS UNAVAILABLE FROM THE DOCTOR'S OFFICE.
PT ALLEGES SHE ACQUIRED SOME PHYSICAL CONDITIONS WHICH MAY HAVE BEEN CAUSED BY THE SILICONE.
IT WAS REPORTED THE BALLOON DETACHED FROM THE SHAFT AND REMAINED IN THE PT AFTER HAVING BEEN INFLATED TO FIVE ATMS. THE PT UNDERWENT SURGICAL RETRIEVAL OF THE BALLOON. TO DATE, ATTEMPTS TO OBTAIN FURTHER DETAILS REGARDING THE TYPE OF PROCEDURE AND PT CONDITION, AS WELL AS THE CIRCUMSTANCES SURROUNDING THIS EVENT, HAVE BEEN UNSUCCESSFUL. SHOULD FURTHER DETAILS BECOME AVAILABLE, A SUPPLEMENT WILL BE FORWARDED UNDER 1219544-1996-00154. THE INTERNATIONAL PRELIMINARY EVALUATION REVEALED THE BALLOON MATERIAL HAD DETACHED FROM THE CATHETER SHAFT AND WAS NOT RETURNED FOR EVAL. GLUE WAS NOTED ON THE TIP AND SHAFT. SHOULD FURTHER FINDINGS BECOME AVAILABLE, A SUPPLEMENT WILL BE FORWARDED UNDER 1219544-1996-00154. WITHOUT FURTHER DEATILS, CO IS UNABLE TO DETERMINE THE CAUSE FOR THIS EVENT.
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED IN INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
REMOVAL OF PENILE PROSTHESIS DUE TO URETHRAL EROSION.
LARGE SLIT IN TUBING NEAR MIDDLE OF THE SET.
SUPPLEMENTAL INFO PROVIDED STATES, "PROGRESSION OF ILLNESS LEADING TO DIAGNOSIS OF MULTIPLE SCLEROSIS; POSSIBLE FIBROMYALGIA AND RHUEMATOID ARTHRITIS AND OTHER UNDETERMINED DEGENERATIVE NEUROLOGICAL DISEASE; EYESIGHT WORSE, HEARING LOSS."
METHOD(86): PART NOT RETURNED. L/N NOT AVAILABLE FROM DR.
DURING A SURGICAL PROCEDURE THE ELECTROCAUTERY SHUT DOWN AND DISPLAYED MESSAGE "CORD FAULT." THE UNIT WAS CHECKED AND ALL CONNECTIONS WERE FINE. THE MFR CHANGED THE ELECTROCAUTERY PENCIL WITH ATTACHED CORD AND EVERYTHING WORKED FINE.
UNDERDELIVERY REPORTED. THE PUMP WAS PROGRAMMED TO DELIVER A TPN SOLUTION AT UNSPECIFIED SETTINGS. THE PT REPORTED THAT AN ALARM HAD SOUNDED, BUT HE DID NOT RECALL THE ALARM MESSAGE. HE WAS ABLE TO RE-PROGRAM THE PUMP, HOWEVER HE NOTED THAT ONLY 1/2 OF THE IV CONTAINER WAS EMPTY AT THE EXPECTED END DELIVERY TIME. HE ATTEMPTED TO USE THE PUMP AGAIN ON THE FOLLOWING DAY, BUT COULD NOT GET PAST AN UNSPECIFIED ERROR CODE. HE DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE EVENT. THE PUMP WAS SWITCHED OUT.
THE PUMP'S HISTORY LOG REVEALED "CHECK CARTRIDGE". "OCCLUSION", AND "ERROR 143" ALARMS. AN INFUSION TEST WITH TPN, TAPER UP & DOWN RAN WITHIN SPECIFICATIONS. WE EXPECTED 1479.8 ML AND MEASURED 1445.7G% ERROR -2.30. THE PUMP PASSED THE DIAGNOSTIC OPTIC BLOCK TEST. THE LATCH ASSEMBLY WORKED CORRECTLY.
PT ALLEGES HAVING SERIOUS PROBLEMS WITH THE IMPLANTS AND EACH PASSING DAY HER PROBLEMS GET WORSE; HOWEVER, NO SPECIFIC PROBLEMS WERE GIVEN.
THE IMPLANT DID NOT INTEGRATE. ONE PERSON AFFECTED.
PATIENT MEDICAL HISTORY WAS FINALLY RECEIVED. THE REPORTED INFECTION IS THE PROBABLE CAUSE OF FAILURE.
THE CAMERA OPERATOR NOTICED GAS LEAKAGE. A RUBBER SEAL ON THE TROCAR WAS FOUND TO BE SPLIT IN (3) SECTIONS OF (2) OF THE TROCARS.
DR REPORTED THAT THE TINE MAY HAVE BROKEN ON AN IMPLANT. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-00272.
UNDERDELIVERY REPORTED. THE PUMP WAS IN USE DELIVERING AN UNSPECIFIED EPIDURAL ANALGESIC AT A CONTINUOUS RATE OF 8 ML/HR. THE NURSE REPORTED THAT SEVERAL ALARMS INDICATING "LOW RESERVE VOLUME" HAD SOUNDED. WHEN THE NURSE WENT TO CHANGE THE IV CONTAINER, IT WAS STILL ALMOST FULL. THE PT EXPERIENCED SOME "STIFF MUSCLES" BUT WAS REPORTED TO BE WITHOUT PAIN ALL DAY. NO ADVERSE EFFECTS REPORTED. THE DEVICE WAS SWITCHED OUT AND PAIN THERAPY CONTINUED.
CUSTOMER BIOMEDICAL ENGINEERING TESTED THE PUMP AND REPORT THAT IT PASSED ALL TESTING. THE PUMP HAS BEEN PLACED BACK INTO PT USE AND IS FUNCTIONING APPROPRIATELY.
IMPLANT PLACED 10/22/96. PT HAD SEVERE ATROPHY IN THE MAXILLARY RIDGE. IMPLANT DIDN'T ADAPT TO THE SURGICAL SITE. DATE OF OCCURRENCE IS UNK. ONE PERSON AFFECTED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. NO MEDICAL HISTORY, WHICH CAN INDICATE WHETHER OR NOT ANY PT HEALTH ISSUES ARE INVOLVED, HAS BEEN RECEIVED. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
SUPPLEMENTAL INFO STATES PATIENT HAS ATYPICAL RHEUMATIC SYNDROME, LEAKING OF PROSTHESIS AND CONSTANT KIDNEY AND BONE INFECTION.
DISTRIBUTOR REPORTED THAT TWO OUT SEVEN IMPLANT FIALED TO INTEGRATE. PT IS REPORTEDLY FINE.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENTS THEMSELVES. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE LOT HISTORY WAS COMPLETED AND FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
(R) BASILIC PICC CATHETER LEAKING AT BASE OF JUNCTION WHEN EACH LUMEN FLUSHED. LINE DISCONTINUED AT THAT TIME.
PT ALLEGES THE IMPLANTS LEAKED AND MOVED OUT OF THE CORRECT POSITION. SURGERY WAS SCHEDULED FOR 1/29/85 BUT WAS DELAYED DUE TO AN AUTOMOBILE ACCIDENT. PT STATES AFTER REMOVAL, DR HAD TISSUE CHECKED AND IT WAS "OK."
OVERDELIVERY REPORTED BY CO'S AFFILIATE. REPORT STATES: "NOT DELIVERING DROP RATE PROPERLY. SOLUTION (CYTOSTATIC) WAS INFUSED IN 4 HOURS INSTEAD OF 24 HOURS PROGRAM". THE REPORT INDICATES NO SIDE EFFECT WAS EXPERIENCED BY THE PT. NO FURTHER INFO IS AVAILABLE.
REPORTED PROBLEM COULD NOT BE DUPLICATED. THE FREQUENCY OF DEATH OR SERIOUS INJURY FOR CODE 102 (OVERDELIVERY) FOR PUMP IS APPROX .21 MILLION SETS.
PT'S IMPLANTS ARE LEAKING INTO HER BLOOD STREAM.
DR REPORTED THAT TWO IMPLANTS FAILED. PT IS REPORTEDLY FINE.
WHILE SURGERY WAS IN PROGRESS, DOCTOR SAW SPARKS COMING FROM ELECTROSURGICAL PENCIL. PENCIL TIP WAS ACTIVE/HOT. MACHINE WAS TURNED OFF. PENCIL WAS PART OF A CUSTOM LAP PACK PROVIDED BY CO.
PATIENT ALLEGES HER RIGHT IMPLANT OUTER SHELL DEFLATED AND IT MAY BE RUPTURED. SHE ALSO HAS LOST SOME FLUID FROM THE IMPLANT.
THE HOSP INCORRECTLY REPORTED CATALOG NUMBER 130309. THE CORRECT CATALOG NUMBER IS 130318. EVAL SUMMARY: THE ACTUAL DEVICE WAS RETURNED TO CO AND  EVALUATED ON 10/23/96 AND 10/28/96. PERFORMANCE TESTING OF THE PENCIL REVEALED THAT IT PERFORMED ACCORDING TO SPECS. THE PENCIL WAS DISASSEMBLED, A SMALL WIRE WAS FOUND LOOSE INSIDE THE SILICONE SLEEVE. MANUFACTURING WAS INFORMED. CORRECTIVE ACTION HAS BEEN TAKEN.
RPTR HAD BEEN IN ACUTE PAIN.  HAD GOTTEN A CHEST X-RAY, AND A SILICONE SENSITIVITY TEST AND WHILE THERE, RPTR'S BREAST OPENED, DRAINED AND STARTED PUSHING THE RUPTURED IMPLANT AND NECROTIC TISSUE OUT. (*)
PT ALLEGES SHE QUIT TREATMENT IN 7/93, BECAUSE SHE COULDN'T STAND THE SURGERIES AND CLOSED CAPSULOTOMIES ANYMORE; HOWEVER, SHE CONTINUES WITH TREATMENT TODAY. SHE CLAIMS THE AREA UNDER HER BREAST BECOMES IRRITATED BECAUSE IT IS HOLLOW OR SUNKEN. THE TIP ALSO BECOMES IRRITATED BECAUSE OF THE RUBBING OF THE EXTERNAL PROSTHESIS SHE HAS TO WEAR. PT ALSO HAS PAIN, SUFFERING AND DISFIGUREMENT.
THE HOSP INCORRECTLY IDENTIFIED THE DEVICE AS CATALOG NUMBER 130309. IT WAS CATALOG #130318. THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 10/23/96 AND 10/28/96. PERFORMANCE TESTING OF THE PENCIL REVEALED THAT IT PERFORMED ACCORDING TO SPECS. THE PENCIL WAS DISASSEMBLED A SMALL WIRE WAS FOUND LOOSE INSIDE THE SILICONE SLEEVE. MANUFACTURING WAS INFORMED. CORRECTIVE ACTION HAS BEEN TAKEN.
PT WAS ON CARDIOPULMONARY BY-PASS FOR APPROX 21 MINS WHEN THE OUTFLOW TRAC OF THE VENOUS RESERVOIR COLLAPSED AND WOULD NOT ALLOW BLOOD OUT. BAG WAS REPLACE. NO HARM TO PT.
PT ALLEGES SHE HAS HAD NINE SURGERIES BECAUSE THE IMPLANTS OF VARIOUS MFRS WERE "INFECTED OR RUPTURED." SHE ALSO ALLEGES SHE WAS IN PAIN AND STATES, "THE IMPLANTS WERE THE CAUSE OF IT." PHYSICIAN STATES PT SUFFERS FROM SILICONE-RELATED ATYPICAL CONNECTIVE TISSUE DISEASE, WITH THE FOLLIWING DIAGNOSTIC SYMPTOMS: JOINT PAIN, FATIGUE, SICCA SYMPTOMS, RAYNAUDS, BURNING PAIN AND DISFIGUREMENT OF BOTH BREATS, IRRITABLE BOWEL, AND OBJECTIVE NEUROPSYCHIATRIC.
REAR S/F DAB PAINTED R & L DEALER CLAIMS FRAMES BROKE.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REUQIREMENTS. REVIEW OF THE LOT HISTORY OF THE SUBJECT PRODUCT WAS FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
NO OBSERVABLE DEFECTS COULD BE FOUND WITH THE COMPONENT ITSELF. MEASUREMENTS TAKEN MET DESIGN REQUIREMENTS. A REVIEW OF THE PRODUCT'S LOT HISTORY WAS COMPLETED AND FOUND TO BE ACCEPTABLE PER RELEASE CRITERIA.
METHOD(86): PART NOT RETURNED. L/N NOT AVAILABLE FROM DR'S OFFICE.
DR REPORTED THAT A TEMPORARY GINGIVAL CUFF BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT 2023141-1996-00273.
METHOD(860:) PART NOT RETURNED. L/N NOT AVAILABLE FROM DR.
QR AXLE MAG W/NUT. DEALER CLAIMS BALL BEARINGS FELL OUT OF THE AXIE.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE RPORTABLE EVENT.
NO INFO WAS GIVEN, IT IS ASSUMED TO BE A BROKEN ABUTMENT UNLESS INFO IS GIVEN OTHERWISE.
TUBING BROKE AT VENOUS TRANSDUCER MID-TREATMENT. NO PT INJURY.
X-TUBE ASSM 16" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC,. ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
BLOOD WAS NOTICED IN CATHETER TUBING. PUMP WAS PLACED ON 1:3 RATIO AND FLUTTERING FOR PHYSICIAN ARRIVAL. BALLOON WAS REMOVED, PT IS STABLE, AND NO NEW CATHETER WAS INSERTED.
EVENT COMPLICATIONS: <NONE FROM THE EVENT - REPORTED 10/8/96.> PATIENT'S CURRENT STATUS: <STABLE - RPT'D 10/8/96.>
THIS SET IS USED WITH AN AUTOMATIC IV COMPOUNDER TO PREPARE TPNS FROM BULK DOSE CONTAINERS. FOR TWO YEARS RPTR HAS USED THESE SETS EVEN THOUGH THEY CONSISTANTLY LEAK AND FORM PUDDLES IN THE LAMINAR-FLOW HOOD FROM SEVERAL DIFFERNT SOURCES. THESE SITES OF LEAKAGE DRIP CONSTANTLY WHETHER THE PUMP IS RUNNING TO COMPOUND A TPN OR AT TEST. RPTR HAD CONVINCED HIMSELF THAT THIS SET DRIPS OUTWARD AND NO AIR OR PARTICLES WERE GOING INTO BULK CONTAINERS. HOWEVER, RPTR REALLY FEELS THAT THIS SET IS A DANGER TO THE PTS RECEIVING THESE TPNS, SINCE IT'S NOT A CLOSED SYSTEM AND IS BEING VENTED BY BYPASSING THE VENTS WHICH DON'T ALLOW AIRFLOW. WHEN PUMPING FROM GLASS BULK CONTAINERS SUCH AS INTRALIPIDS, PUMP CAUSES A NEGATIVE PRESSURE TO BUILD INSIDE THE BOTTLE AND THE PUMP MOTOR SOON BURNS-UP FIGHTING THIS VACCUM. USERS PUMP HAS BEEN REPLACED 5 TIMES. TO PREVENT THIS, USER NOW HAS TO REMOVE THE VENT FROM THE SPIKE TO ALLOW AIR TO ENTER THE BOTTLE. THIS IS A SECOND DANGEROUS SOURCE OF CONTAMINATION. WHEN THE CO REP WAS INFORMED OF THE PROBLEMS, USER WAS TOLD THAT NO OTHER CLIENTS HAD COMPLAINTS.
MONITORING NURSE NOTICED BLOOD IN THE CATHETER TUBING. BLOOD PUMP WAS TURNED OFF, DISCONNECTED AND BALLOON CATHETER WAS REMOVED. PT IS STABLE, NO NEW CATHETER WAS INSERTED.
X-TUBE ASSM 17" X 16". DEALER CLAIMS X-TUBE BROKE ON LEFT SIDE AT LOWER WELD.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE QUICKIE DESIGNS, INC, ITS EMPLOYEES ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE NURSE NOTED BLOOD IN THE CATHETER TUBING. IABP WAS DISCONTINUED AND THE BALLOON WAS REMOVED. NO SECOND WAS INSERTED. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 10/8/96. PT CURRENT STATUS: DOING WELL - RPT'D 10/8/96.
THE FEMORAL COMPONENT WAS REVISED FOR WEAR.
SUMMARY OF EVALUATION: THE DEVICE AS RECEIVED EXHIBITS MINOR NORMAL WEAR ON THE CONDYLAR SURFACES AS SURFACE DEFORMATION IN A SYMMETRICAL PATTERN BUT WITH A SLIGHT ANTERIOR PREFERENCE. THE FEMORAL COMPONENT SHOWS SOME MINOR SCRATCHES ON BOTH CONDYLES AND A SMALL PATH OF BURNISHING AT THE MEDICAL EDGE OF THE MEDIAL CONDYLE AS WELL AS AT A MEDIAL ANTERIOR LOCATION ON THE LATERAL CONDYLE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH THE INSERT AND THE FEMORAL COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE INFO PROVIDED AND THE EXAMINATION RESULTS ARE INSUFFICIENT TO DETERMINE WHETHER THIS EVENT IS DEVICE RELATED.
STUDENT NURSE STARTED AN IV IN THE PREGNANT PT'S LEFT FOREARM. GOOD BLOOD RETURN NOTED. RN ADVANCED THE CATHETER FOR THE STUDENT. IV INFUSING, BUT FLUID NOTED BENEATH THE SKIN. IN ATTEMPTING TO REMOVE THE CATHETER, 1/2 OF CATHETER NOTED. PHYSICIAN HAD TO MAKE AN INCISION TO REMOVE THE REMAINING PORTION OF THE CATHETER. INITIAL VERBAL REPORT FROM NURSING SUPERVISORY PERSONNEL INDICATED CATHETER REMOVED INTACT AS IT WAS NOT COMPLETELY SEVERED. UPON REVIEW OF THE NURSES' NOTES AND CONVERSATION WITH STAFF, CATHETER HAD SHEARED AND INTERVENTION WAS REQUIRED AS NOTED ABOVE.
THE TIBIAL COMPONENT WAS REVISED FOR PAIN.
THE DEVICE IS NOT MFG IN THE US. EVALUATION WILL BE COMPLETED AT THE MFG FACILITY. UPON COMPLETION OF DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN RECEIVED FROM FOREIGN AFFILIATE. USER FACILITY INFO IS UNOBTAINABLE.
REPORT FROM DIST INDICATED THAT THE USER ENCOUNTERED DIFFICULTY IN REMOVING PROTECTIVE LINER. PADS PEELED APART WHEN USER WAS UNABLE TO REMOVE LINER.
THE TIBIAL COMPONENT WAS REVISED FOR WEAR.
SUMMARY OF EVALUATION: THE DEVICE AS RECEIVED EXHIBITS MINOR WEAR ON THE CONDYLAR SURFACES AS SURFACE DEFORMATION IN A SYMMETRICAL PATTERN BUT WITH A SLIGHT ANTERIOR PREFERENCES. THE FEMORAL COMPONENT SHOWS SOME MINOR SCRATCHES ON BOTH CONDYLES AND A SMALL PATH OF BURNISHING AT THE MEDIAL EDGE OF THE MEDIAL CONDYLE AS WELL AS AT A MEDIAL ANTERIOR LOCATION ON THE LATERAL CONDYLE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH THE INSERT AND THE FEMORAL COMPONENT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE INFO PROVIDED AND THE EXAMINATION RESULTS ARE INSUFFICIENT TO DETERMINE WHETHER THIS EVENT IS DEVICE RELATED.
DATE SENT TO FDA: 11/15/96, CLARIFICATION OF EVAL CODE, METHODS 86: MICROSCOPY 100X. EVAL SUMMARY: IT WAS REPORTED BY THIS FACILITY THAT THIS APPEARS TO HAVE BEEN THE RESULT OF INCCORRECT TECHNIQUE BY THE STUDENT NURSE. THE SAMPLE WAS RETURNED FOR ANALYSIS AND WAS SUBJECTED TO A VISUAL EXAM AND A MICROSCOPIC EXAM AT 100X MAGNIFICATION. A VISUAL EXAM OF THE EYELET ASSEMBLY (METAL INSERT THAT HOLDS THE CATHETER IN PLACE) INDICATED THAT IT WAS PROPER AND INTACT. UNDER MAGNIFICATION, THE ATTACHED SEGMENT OF TUBING SHOWS A V-SHAPED CUT AT THE POINT OF SEVERANCE WITH A LONG PROTRUDING PORTION OF TUBING WHICH INDICATES THAT TENSION CAUSED THE REMAINING ATTACHED TUBING TO SEVER. THE UNATTACHED SEGMENT ALSO SHOWS AN ANGULAR, SMOOTH CUT MOST LIKELY FROM TAPERED END OF THE INTRODUCER NEEDLE. BASED ON THE INFO PROVIDED AND THE RESULTS FROM THE ACTUAL SAMPLE EVAL, CO HAS CONCLUDED THAT THE SEVERED CATHETER WAS A RESULT OF A REINSERTION OR MANIPULATION OF THE INTRODUCER NEEDLE DURING THE INSERTION PROCESS. SEVERANCE CAN OCCUR WITH ANY INTRAVENOUS CATHETER WHEN IMPROPER PROCEDURES ARE EMPLOYED DURING USE. DEVICE INSTRUCTIONS, WHICH ACCOMPANY THE PRODUCT, CAUTION AGAINST THE PRACTICE OF REINSERTING THE INTRODUCER NEEDLE WHILE ATTEMPTING TO ENTER THE VEIN AS THIS MAY PUNCTURE THE TUBING. THE CORRECTIVE ACTION FOR THIS COMPLAINT WILL BE COMMUNICATING CO'S FINDINGS TO THE CUSTOMER AND ADVISING THE CUSTOMER TO REVIEW THE INSTRUCTIONS ON THE  PROPER USE OF THE DEVICE.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE BOLT HOLE.
HIGH STRESS FACTOR AT CENTER AND END OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
INTRACAPSULAR RUPTURE OF LEFT SILICONE-GEL FILLED BREAST IMPLANT.
THE ACETABULAR COMPONENT WAS REVISED FOR LOOSENING. THE INSERT WAS ALSO REVISED ALONG WITH THE ACETABULAR COMPONENT.
THE DEVICE IS NOT AVAILABLE FOR EVALUATION. DEVICE INFO HAS BEEN REQUESTED FROM THE USER FACILITY. IF INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. UPON RECEIPT OF COMPLETE CATALOG NUMBERS A BASELINE REPORT WILL BE SUBMITTED.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.THE REPORTED EVENT IS OCCURRING AT A FRQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
BALLOON ANGIOPLASTY WAS BEING PERFORMED ON STENOTIC LESION OF THE LEFT ARM. AFTER PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAD RUPTURED PART OF THE BALLOON REMAINED IN THE VESSEL. SMALL INCISION REQUIRED TO REMOVE BALLOON. THERE WAS NO SERIOUS INJURY TO THE PT. VITAL SIGNS REMAINED STABLE THROUGH PROCEDURE.
DEVICE WAS INSERTED INTO APPREHENSIVE PT WHO THEN DEVELOPED ITCHINESS AND FLUSHING OF HANDS, MOUTH, FEET, CHEST, AND BACK. PT ALSO EXHIBITED WELTS FROM THE SCRATCHING. CLINICIAN CALLED THE PT'S DR AND HE FELT THIS WAS A STRESS RESPONSE. CLINICIAN REPORTED USING THE RECOMMENDED INSERTION TECHNIQUE AND FLUSHED WITH APPROX 30CC OF NORMAL SALINE. PT'S B/P WENT FROM 110/80 TO 160/98. THERE WAS NO RESPIRATORY DISTRESS. BENARYL PO WAS GIVEN AND THE SYMPTOMS SUBSIDED APPROX 30 MINUTES AFTERWARDS. THE DEVICE WAS LEFT IN PLACE. A FOLLOW-UP CALL THE NEXT DAY INDICATED THE PT WAS DOING FINE.
DATE SENT TO FDA: 11/15/96 B4,F8,G4-MFR'S ALERT DATE. IN SPITE OF RESEARCH DONE TO DATE, CO HAS NOT BEEN ABLE TO ESTABLISH CAUSALITY FOR THE TYPE REPORTED. FOR BUSINESS REASONS, CO HAS DECIDED TO DISCONTINUE MFG AND SALE OF THE I.V. CATHETER. CO WILL CONTINUE TO TRACK THIS TYPE OF INFO AS IT IS IMPORTANT TO PRODUCT IMPROVEMENT AND DEVELOPMENT PROCESS.
X-TUBE. CONSUMER CLAIMS VIA E-MAIL HIS X-TUBE IS BROKEN.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING AN ILIAC DILATATION PROCEDURE, THE CATHETER BALLOON RUPTURED AFTER THE FOURTH INFLATION. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS REPORTED.
INVESTIGATION CONDUCTED. DR CITES INSUFFICIENT BONE QUALITY AS CAUSE FOR FAILURE. THIS CASE IS CLOSED.THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
QUICK RELEASE CASTER STEM O/S. DEALER CLAIMS THE QUICK RELEASE STEM BROKE AT BASE OF THREADS.
HARD IMPACT AGAINST NON-MOVEABLE OBJECT CAUSED FAILURE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSIONBY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
PT WAS REVISED BASED ON SYMPTOMS OF DECREASED HEARING SHORTLY AFTER SURGERY. SURGICAL INTERVENTION REVELAED THAT THE HEAD DISPLACED OFF THE SHAFT OF THE IMPLANT. REPLACEMENT WAS IMPLANTED.
THE DEVICE THAT WAS RETURNED AND EVALUATED AND IN TWO PIECES. THE HEAD SEPARATED FROM THE SHAFT. THE IMPLANT SHAFT APPEARS TO HAVE BEEN SIZED TO FIT THE PT BY TRIMMING. THE CUT ON THE SHAFT IS ANGLED AND RAGGED SUGGESTING THAT THE MATERIAL WAS TORN RATHER THAN SLICED. JUDGING THE APPEARANCE OF THE SHAFT WHERE IT WAS TRIMMED, THE DEVICE WAS SUBJECTED TO FORCES CAPABLE OF WEAKENING THE CONNECTION BETWEEN THE HEAD AND SHAFT. IT IS NOT POSSIBLE TO VALIDATE IF THE DEVICE SEPARATED BEFORE SURGERY OF IT IS SEPARATED UPON RETRIEVAL OF THE DEVICE.
FIFTY-NINE-YR-OLD MALE ADMITTED ON 10/12/96 FOR NAUSEA AND DEHYDRATION WAS TAKEN TO THE OR ON 10/15/96 FOR GASTROJEJUNOSTOMY, SECONDARY TO PERFORATED DUODENAL ULCER. ON 11/1/96 PT WAS FOUND UNRESPONSIVE IN ICU. ECG MONITOR LEADS WERE OFF PT, AND THERE WAS NO PULSE AND NO RESPIRATION. PT WAS RESUSCITATED PER ACLS PROTOCOL. PT EXPIRED 11/5/96.
PT WAS REVISED BASED ON SYMPTOMS DECREASED HEARING SHORTLY AFTER SURGERY. SURGICAL INTERVENTION REVEALED THAT THE HEAD DISPLACED OFF THE SHAFT OF THE IMPLANT. REPLACEMENT WAS IMPLANTED.
THE DEVICE EVALUATED WAS IN TWO PIECES. THE HEAD HAD SEPARATED FROM THE SHAFT. THE IMPLANT SHAFT APPEARS TO HAVE BEEN SIZED TO FIT THE PT. THE CUT ON THE SHAFT IS ANGLED AND RAGGED SUGGESTING THAT THE MATERIAL WAS TORN RATHER THAN SLICED. JUDGING THE APPEARANCE OF THE SHAFT WHERE IT WAS TRIMMED, THE DEVICE WAS SUBJECTED TO FORCES CAPABLE OF WEAKENING THE CONNECTION BETWEEN THE HEAD AND SHAFT. IT IS NOT POSSIBLE TO VALIDATE IF THE DEVICE SEPARATED BEFORE SURGERY OF IF IT SEPARATED UPON RETRIEVAL OF THE DEVICE.
A BALLOON RUPTURED AND DETACHED FROM THE CATHETER SHAFT AFTER THE SECOND INFLATION DURING AN ANGIOPLASTY OF A VENOUS STENOSIS. RETRIEVAL OF THE BALLOON UTILIZING A HEMOSTAT WAS UNEVENTFUL. THERE WERE NO PT COMPLICATIONS INVOLVED AND THE ANGIOPLASTY HAD BEEN SUCCESSFULLY COMPLETED WITH THIS UNIT. THIS DEVICE IS NOT AVAILABLE FOR EVAL. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKEAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. FOLLOW UP INDICATED THIS BALLOON WAS INFLATED WITHOUT THE USE OF A PRESSURE GAUGE WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "IT IS ESSENTIAL THAT AN INFLATION DEVICE WITH A PRESSURE GAUGE (ITS C/N 15-101 OR ITS EQUIVALENT) BE USED TO MONITOR PRESSURE WITHIN THE BALLOON TO DETEMINE THE ADEQUATE DILATION FORCE IS APPLIED WHILE NOT EXCEEDING THE MAXIMUM LIMITS OF THE PRODUCT. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
INFO SUPPLIED IN SECTION F ON THIS MEDWATCH REPORT HAS BEEN PROVIDED BY THE MFR.
A BALLOON RUPTURED ON ITS FIRST INFLATION DURING AN ANGIOPLASTY AND STENT DILATATION. UPON REMOVAL OF THIS BALLOON CATHETER THE CATHETER BECAME HUNG UP ON A VASCULAR CLIP. THE DISTAL PORTION OF THE SHAFT AND THE RADIOPAQUE MARKER DETACHED. RETRIEVAL OF SEMENT AND RADIOPAQUE MARKER UTILIZING A SNARE AND FORCEPS WAS UNEVENTFUL. THERE WERE NO PT COMPLICATIONS INVOLVED. THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION REVEALED THE BALLOON  REMAINED ATTACHED TO THE SHAFT. THE SHAFT WAS ELONGATED TWENTY SIX CENTIMETERS FROM THE PROXIMAL RADIOPAQUE MARKER TO THE DISTAL TIP. THE DISTAL TIP OF THE SHAFT AND THE DISTAL RADIOPAQUE MARKER WERE NOT RETURNED. THE BALLOON SURFACE WAS SCRATCHED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. DILATATION OF A STENT MAY RESULT IN CONTACT WITH A SURFACE THAT COULD DAMAGE THE BALLOON MATERIAL. CO'S FOLLOW UP ALSO INDICATED THE BALLOON MAY HAVE COME IN CONTACT WITH THE VASCULAR CLIP PRIOR TO INFLATION. ENGINEERING EVALUATION REVEALED AN ELONGATED SHAFT WHICH IS A CHARACTERISTIC CONSISTENT WITH EXCESSIVE EXERTION AGAINST RESISTANCE AND SCRATCHES ON THE BALLOON SURFACE, WHICH IS INDICATIVE OF CONTACT WITH A SHARP EXTERNAL SOURCE. SINCE FOLLOW UP INDICATED BOTH A VASCULAR CLIP AND A STENT WERE PRESENT, CO BELIEVES THESE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."
INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA. H6. 86(OTHER)-MICROSCOPIC EXAMINATION.
REPORTER FELT THAT UNIT MALFUNCTIONED CAUSING A TORN CAPSULE.
H-10: A COMPANY SERVICE REP CHECKED THE SYSTEM AND FOUND IT TO MEET ITS PERFORMANCE SPECIFICATIONS. NO CONSUMABLES WERE SAVED FOR EVAL. MISSING INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. H.11: SECTION F INFO PROVIDED BY USER FACILITY. THIS REPORT WAS MAILED IN TO FDA ON: 11/13/96.DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
PT WAS REVISED BASED ON SYMPTOMS OF DECREASED HEARING SHORTLY AFTER SURGERY. SURGICAL INTERVENTION REVEALED IMPLANT DISPLACED (TIPPED OVER). REPLACEMENT IMPLANT WAS PUT IN.
PT WITH IDENTIFIED TIGHT STENOSIS OF DISTAL "R" CORONARY GRAFT. DR PERFORMED TEC AND STENTING AT THAT LESION WITH GOOD RESULT. IN ATTEMPTING TO PLACE AN ADD'L STENT IN THE MID-PORTION OF THE "R" CORONARY GRAFT, DIFFICULTY WAS ENCOUNTERED IN POSITIONING STENT. DURING ATTEMPT TO REMOVE STENT ASSEMBLY, STENT WAS STRIPPED OFF BALLOON CATHETER. STENT WAS LODGED IN "R" FEMORAL ARTERY. A RETRIEVAL DEVICE WAS DEPLOYED TO TRY TO RETRIEVE THE STENT. GUIDE WIRE ALSO BECAME LOOPED AROUND IABP CATHETER. REPEATED ATTEMPTS MADE TO GET STENT OUT. PT BECAME HYPOTENSIVE - HAD TO BE INTUBATED. TRANSFUSIONS GIVEN. DUE TO LARGE BLOOD LOSS AND HEART FAILURE, HOSP WAS UNABLE TO SUSTAIN PRESSURE OR HEART RATE.
INVESTIGATION CONDUCTED. DR CITES PREVIOUSLY UNKNOWN DIABETES AS CAUSE FOR FAILURE. PATIENT ALSO IS A BRUXOR. THIS FILE IS CLOSED. THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS USUAL FOR THIS TYPE OF DEVICE.OTHER FAILED IMPLANTS FROM BOX D6: MODEL/CATALOG # 3912HL/3912HL  LOT #954355
DISCLAIMER: SAFESKIN CORP (SAFESKIN) SUBMITS THE FOLLOWING REPORT TO THE FDA IN COMPLIANCE WITH 21 CFR 803. THIS REPORT IS BASED UPON INFORMATION PROVIDED FROM A LAWSUIT IN WHICH SAFESKIN IS NAMED DEFENDANT. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY SAFESKIN THAT THE PRODUCT(S) DESCRIBED HEREIN ARE PRODUCTS OF ITS MANUFACTURE AND ARE OR WERE DEFECTIVE OR DANGEROUS IN ANY RESPECT, OR THAT ANY CASUAL RELATIONSHIP EXISTS BETWEEN THESE PRODUCTS AND ANY ACTUAL OR POTENTIAL INJURY. IN ADDITION, THE SUBMISSION OF A REPORT BY SAFESKIN SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED.
ON DECEMBER 1, 1998, SAFESKIN CORP WAS SERVED WITH THE FOLLOWING LAWSUIT: PLAINTIFF'S CLAIM ALLEGES THE FOLLOWING: PLAINTIFF WAS DIAGNOSED ON APRIL 10, 1995 AS SUFFERING FROM TYPE 1 LATEX ALLERGY AND REACTIVE AIRWAYS DISEASE. PLAINTIFF DEVELOPED A LIFE THREATENING IMMEDIATE HYPERSENSITIVITY TO LATEX. SHE LIVES WITH DIMINISHED PULMONARY FUNCTIONING AND THE CONTINUAL PROBABILITY THAT SHE WILL HAVE AN ANAPHYLACTIC REACTION UPON CONTACT WITH ANY TYPE OF LATEX PRODUCT. SHE WAS UNABLE TO RETURN TO WORK DUE TO HER SENSITIVITY TO LATEX.
THE CUSTOMER REQUESTED THAT THE SYSTEM BE CHECKED OUT. DURING FUNCTIONAL TEST, ENOUGH LIQUID OXYGEN LEAKED DURING AND AFTER FILL FROM THE BROKEN FLOW INDICATOR TO POTENTIALLY CAUSE A SERIOUS INJURY IF THIS EVENT WERE TO RECUR. THE CUSTOMER CONFIRMED THAT NO INJURY DID NOT OCCUR AS A RESULT OF THIS MALFUNCTION. CO'S SERVICE TECH ALSO REPORTED THAT THE BOTTLE HAS A LOSS OF VACUUM, THE QUICK CONNECT LEAKS, AND THE KNOB, BEZEL AND CASE BACK ARE CRACKED. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MANUFACTURING PROCESS PER THE APPROVED DMR. A CORRECTIVE ACTION WAS IMPLEMENTED WHICH REMOVED THE FLOW INDICATOR FROM UNITS MANUFACTURED AFTER APRIL 5, 1995.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT REMOVAL DUE TO FAILURE OF THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT LOSS REPORTED. THE PT REPORTEDLY UNDERWENT A SECOND, UNSCHEDULED TREATMENT. A MES (MEDICAL EQUIPMENT SVC) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 11/04/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED OL, INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE, IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. CUSTOMER CONTACTED: NO. TRAINING REQUIRED: NO.
CO RECEIVED INFO THAT A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A TRANSVENOUS DEFIBRILLATION LEAD (0125) HAD RECEIVED THERAPY IN THREE SEPARATE OCCASIONS, AND WAS BROUGHT IN FOR AN EVALUATION. AN INVASIVE PROCEDURE WAS PERFORMED AND ELECTRICAL ABNORMALITIES WERE IDENTIFIED WITH THE LEAD. THE LEAD WAS CAPPED, AND A NEW LEAD IMPLANTED.
INFORMATION PROVIDED FROM LAWSUIT. NO FURTHER INFORMATION AVAILABLE.
ALL INFORMATION PROVIDED IN THIS REPORT WAS ACQUIRED THROUGH A PENDING LAWSUIT. CO HAS NO PRIOR RECORD OF A PRODUCT PROBLEM OR ADVERSE EVENT RELATIVE TO THIS SITUATION.
EQUIPMENT FAILURE WAS NOT FELT TO HAVE CONTRIBUTED TO PT'S DEATH HOWEVER, INSTRUCTIONS WERE FELT TO BE CONFUSING AND RESULTED IN USER ERROR. INSTRUCTIONS ON MACHINE SAY "CHECK ECG AND DEFIB ELECTRODE POSITIONS." INSTRUCTIONS DO NOT CLEARLY EXPLAIN THAT YOU NEED TO APPLY BOTH ELECTRODES AND PACER PADS. DURING AN EMERGENCY YOU DO NOT HAVE TIME TO REFERENCE A MANUAL INSTRUCTIONS. NEED TO BE ON MACHINE. FACILITY HAS SINCE ADDED THEIR OWN INSTRUCTIONS FOR ASSURANCE OF CLEAR AND CONCISE INSTRUCTIONS.
THE CUSTOMER REQUESTED THAT THE SYSTEM BE CHECKED OUT. DURING FUNCTIONAL TEST, ENOUGH LIQUID OEXYGEN LEAKED FROM THE CRACKED FLOW INDICATOR TO POTENTIALLY CAUSE A SERIOUS INJURY IF THIS MALFUNCTION WERE TO RECUR. CO'S SERVICE TECH ALSO REPORTED THAT THE CONNECTING TUBES APPEARED TO HAVE BEEN MELTED AND WERE MIXED, THE VENT VALVE LEAKED, AND THE BEZEL WAS CRACKED. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MANUFACTURING PROCESS PER THE APPROVED DMR. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED WHICH REMOVED THE FLOW INDICATOR FROM UNITS MANUFACTURED AFTER APRIL 5, 1995.
DATE SENT TO FDA: 11/15/96. INVESTIGATION SUMMARY: WITH NO SAMPLE AND NO LOT NUMBER, CO WAS UNABLE TO COME TO ANY CONCLUSION WITH REGARD TO THIS EVENT, HOWEVER, A REVIEW OF PREVIOUS SAMPLE EVALUATIONS FOR SIMILAR EVENTS AS WELL AS REVIEW OF THE INSERT FOR THE PRODUCT INDENTIFIED WAS CONDUCTED. PREVIOUS SMAPLES RETURNED FROM CUSTOMER HAVE BEEN VISUALLY AND PHOTOGRAPHICALLY EXAMINED AND TESTED FOR TENSILE STRENGTH. EVAL OF THESE RETURNED SAMPLES SUGGEST THAT THE PRODUCT WAS BEING USED IN A MANNER OR SITUATION WHICH WAS INAPPROPRIATE GIVEN THE PT'S INTENDED FUNCTION OR PERFORMANCE LIMITATIONS. EXAM OF SAMPLES (AT THE BROKEN AREA) INDICATE THAT THE DRAINS SUBMITTED MAY HAVE BEEN NICKED BY A SHARP EDGED INSTRUMENT DURING SURGERY OR SURGERY PREPARATION. PRECAUTIONS INCLUDED IN THE PRODUCT INSERT STATE: ELASTOMER SUCTION DRAIN TUBING IS SOFT AND PLIABLE. IT SHOULD NOT BE HANDLED WITH POINTED, TOOTHED, SHARP-CONCERNED OR EVEN BLUNT INSTRUMENTS, AS SURFACE CUTS, NICKS, CRUSHING OR OTHER OVER STRESSING CAN LEAD TO TEARING OR WARPING OF THE TUBE AND TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN AND/OR FRAGMENT RETENTION WITHIN THE WOUND. DO NOT SUTURE THROUGH OR CUT INTO THE DRAIN AS THIS MAY RESULT IN DRAIN BREAKAGE AND/OR FRAGMENT RETENTION WITHIN THE WOUND."QUALITY RECORDS HAVE BEEN REVIEWED AS PART OF PRIOR INVESTIGATIONS AND NO NONCONFORMANCES HAVE BEEN NOTED. THE OCCURRENCE OF BROKEN DRAINS, INCLUDING THOSE SUTURED IN PLACE, CONTINUES TO BE INFREQUENT RELATIVE TO THE VOLUME OF DRAINS PRODUCED. THERE HAS BEEN NO SIGNIFICANT INCREASE IN THE NUMBER OF COMPLAINTS RECEIVED FOR DRAIN BREAKS WHEN LOOKING AT AVERAGES DURING 1995 AND 1996. CONSIDERING THE DATA ANALYSIS, THE LEVEL OF BROKEN DRAIN COMPLAINTS RECEIVED IN 1996 IS AT A LOW LEVEL RELATIVE TO THE VOLUME OF DRAINS SOLD. ALTHOUGH COMPLAINTS FOR BROKEN DRAINS CONTINUE AT A LOW LEVEL, TRENDS WILL BE MONITORED. NO FURTHER INVESTIGATION WILL BE CONDUCTED UNLESS WARRANTED BY AN UNEXPECTED AND SIGNIFICANT INCREASE IN COMPLAINTS FOR BROKEN DRAINS.
DURING AN SFA DILATION PROCEDURE, THE CATHETER BALLOON RUPTURED AFTER THE FIRST INFLATION. THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME MAKE TO COMPLETE THE PROCEDURE WITH NO PT INJURY OR FURTHER COMPLICATIONS BEING REPORTED.
BLOCK B6 & B7 WERE CHANGED TO "UNK" AS SEVERAL ATTEMPTS WERE MADE WITH NOT AVAIL TO OBTAIN THE INFORMATION.
NO DETAILS AVAILABLE. INFORMATION PROVIDED FROM LAWSUIT. NO PRIOR COMPLAINT DOCUMENTED.
ON 10/23/96, THE MFR'S TECHNICAL SALES REPRESENTATIVE WAS INFORMED OF A PROBLEM WITH THIS DEVICE; HOWEVER, SPECIFIC DETAILS CONCERNING THE PROBLEM WERE NOT AVAILABLE AT THAT TIME EXCEPT THAT THE DEVICE MAY BE EXPLANTED ON 10/28/96. ON 10/28/96, THE MFR'S TECHNICAL SALES REPRESENTATIVE WAS INFORMED THE DEVICE WAS EXPLANTED (10/28/96), AND WAS SBEING RETURNED TO THE MFR FOR ANALYSIS. ADDITINALLY, THE IMPLANTING PHYSICIAN NOTED THAT THE DEVICE WAS BLOCKED ON THE RIGHT SIDE OF THE DUAL LUMENT WITH CATHETER TIP ON TOP PRIOR TO INSERTION OF THE DEVICE. THE DEVICE WAS RETURNED TO THE MFR ON 10/29/96, FOR ANALYSIS.
THE DEVICE WAS RETURNED TO THE MFR ON 10/29/96, AND HAS BEEN ANALYZED AS FOLLOWS: BOTH DEVICE SEPTA SHOWED NO ANOMALIES INCLUDING INTERNAL DAMAGE. THE 6 1/4" DUAL LUMEN CATHETER SHOWED NO CUTS, TEARS OR HOLES. THE LEFT SEPTUM WAS PATENT AND FLOWED WITH NO RESISTANCE. THE RIGHT SEPTUM TOOK MUCH PRESSURE TO COLLLECT A FEW RED DROPLETS OF FLUID WHICH TESTED POSITIVE FOR BLOOD. BOTH SIDES OF THIS DEVICE DID NOT LEAK WHEN APPLYING 60 PSI OF AIR. MICROSCOPIC EVALUATION REVEALED THE STRAIN RELIEF MAY BE BLOCKING THE RIGHT SIDE FLOW PATH. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG/LOT NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW  OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT. BASED ON THE INFO AVAILABLE AND THE RESULTS OF S/I'S ANALYSIS, THE CUSTOMER'S COMPLAINT THAT "BLOCKED PRIOR TO INSERTION ON RIGHT SIDE OF DUAL LUMEN WITH CATHETER AT TOP", HAS BEEN CONFIRMED. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
TIP OF RESECTOSCOPE INNER SHEATH SEPARTED IN PT AND HAD TO BE RETRIEVED IN SUBSEQUENT SURGERY ON 10/12/96.
ON JANUARY 5, 1998, THE LAWSUIT FILED AGAINST SAFESKIN CORPORATION BY THE PLAINTIFF ALLEGING INJURIES RESULTING FROM EXPOSURE TO SAFESKIN PRODUCT(S) WAS DISMISSED. PRELIMINARY DISCOVERY & SALES TRACE REVEALED THAT SAFESKIN PRODUCTS COULD NOT HAVE POSSIBLY CAUSED THE PLAINTIFF'S INJURIES.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT LOSS REPORTED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. A MES (MEDICAL EQUIPMENT SVC) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT SHOWS THAT IN 3/95, THE PRV'S 1 & 2 WERE RECALIBRATED TO CORRECT EXCESSIVE PRESSURE DRIFT IN THE UF SYSTEM WHICH WAS CAUSING AN AUTOTEST FAILURE. THIS IS NOT RELATED TO THE ISSUE IN THIS COMPLAINT. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 11/08/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED 00.1 OHMS, INDICATING THAT THE FUSE WAS POTENTIALLY GOOD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. IT WAS SEEN THAT THE WAX HAD MELTED PREVIOUSLY, INDICATING THAT THE FUSE HAD BECOME INTERMITTENT. WHEN THE THERMAL FUSE IS IN THE FIRST STAGES OF FAILURE, IT CAN BECOME INTERMITTENT. WHEN THIS HAPPENS, THE UF PUMP WILL RUN FOR A SHORT PERIOD OF TIME. UNTIL THE WAX INSIDE HEATS UP AND MELTS. WHEN THE PUMP COOLS DOWN, THE FUSE BECOMES OPERATIONAL AGAIN. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE RPORTED INCIDENT. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR: NO. TRAINING REQUIRED: NO.
PT FOUND UNRESPONSIVE WITHOUT PULSE AND RESPIRATIONS. DEFIBRILLATION EQUIPMENT WAS PLACED ON PT UTILIZING THE DEFIBRILLATOR COMBO PATCHES. EMERGENCY MEDICAL TREATMENT WAS RENDERED BUT THE PT DID NOT REVIVE. REVIEW OF THE CODE FOUND THE LEAD SELECTION WAS SET ON LEAD II INSTEAD OF THE PATCHES WHICH DID NOT PROVIDE USER WITH AN ACCURATE RHYTHM. DEFIBRILLATOR DOES NOT HAVE THE CAPABILITY TO AUTOMATICALLY SENSE THE TYPE OF LEAD PLACED ON PT. EQUIPMENT REQUIRED THE USER TO MANUALLY SELECT THE LEAD THAT WAS BEING USED. IN THIS CASE, MANUAL SELECTION WAS NOT IMPLEMENTED.
MONITOR ALARM TURNED OFF FOR APPROX 2 AND ONE HALF HRS. PT FOUND AT 0730 UNRESPONSIVE.
ON MARCH 1, 1999, THE LAWSUIT FILED AGAINST SAFESKIN CORPORATION BY THE PLAINTIFF ALLEGING INJURIES RESULTING FROM EXPOSURE TO SAFESKIN PRODUCT(S) WAS DISMISSED. PRELIMINARY DISCOVERY & SALES TRACE REVEALED THAT SAFESKIN PRODUCTS COULD NOT HAVE POSSIBLY CAUSED THE PLAINTIFF'S INJURIES.
SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVAL. SECTION F1-14: HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FROM THE UF. IF INFO IS RECEIVED A SUPPLEMENT REPORT WILL BE SUBMITTED.
NO DETAIS AVAILABLE. INFORMATION PROVIDED FROM LAWSUIT. NO PRIOR COMPLAINT DOCUMENTED.
THE PHYSICIAN TRIED TO REPOSITION THE COIL BUT COULD NOT. HE TRIED TO PUSH IT AND COULD NOT RETRIEVE THE COIL. HE TRIED TO PUSH IT IN AND COULD NOT, HE PULLED IN THE WIRE AGAIN AND THE COIL STRETCHED AND DETACHED. HE WAS UNABLE TO MOVE THE STRETCHED PART WHICH REMAINED IN THE INFERIOR PETROSAL SINUS.
DATE OF PROCEDURE: 10/11/96 THE MAIN COIL WAS NOT RETURNED. THE PUSHER SECTION HAS A KINK 22 CM FROM THE DISTAL END. THE INTERLOCKING ARM SECTION OF THE PUSHER IS IN GOOD CONDITION. ON THE PUSHER, THE STAINLESS STEEL AND PROXIMAL COIL ARE WAVY. THIS WAVINESS COULD INDICATE EXCESSIVE MANIPULATION OF THE DEVICE. THE ANALYSIS OF THE PUSHER SECTION LEADS CO TO THE CONCLUSION THAT THE MAIN IDC COIL BECAME DETACHED DUE TO EXCESSIVE MANIPULATION OF THE DEVICE. FREQUENCY AND SEVERITY OF OCCURRENCE OF THIS EVENT ARE NOT ADDRESSED IN THE DEVICE LABELING. THE REPORTED EVENT IS NOT OCCURRING WITH GREATER THAN EXPECTED FREQUENCY. THE REPORTED EVENT IS NOT OCCURRING WITH GREATER THAN EXPECTED SEVERITY. THIS INFO IS BASED ON INFO SUPPLIED TO US WITHOUT OUR INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHIP TO THE PRODUCT.
NO DETAIS AVAILABLE. INFORMATION PROVIDED FROM LAWSUIT. NO PRIOR DOCUMENTATION OF COMPLAINT.
THIS PUMP WAS NOTED TO HAVE A DISPLAYED RATE WHICH CHANGED WHILE THE PUMP WAS RUNNING. THE ACTUAL OUTPUT OF THE PUMP WAS NOT KNOWN. THE PUMP WAS DISCONTINUED WITHOUT PT CONSEQUENCES. NO ADD'L SPECIFIC INFO WAS ABLE TO BE RECEIVED.
SECTION F COMPLETED BY THE MFR. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION. NO SPONTANEOUS CHANGE IN THE INFUSED RATE WAS OBSERVED WITH THE TESTING.
AFTER A DIFFICULT INSERTION OF THE IV CATHETER DEVICE, A PORTION OF THE DEVICE WAS NOTED TO HAVE BEEN SEVERED. THE REPORTING FACILITY STATES THAT THE DEVICE WAS REMOVED BECAUSE FLUID WOULD NOT INFUSE AT THE SITE. AFTER REMOVAL, A PORTION REPORTED TO MEASURE APPROXIMATELY 1/4 INCH WAS NOTED TO HAVE BEEN SEVERED. THE CLINICIAN NOTED THAT THE INSERTION WAS DIFFICULT AND THAT THE SEVERED PORTION WAS FOUND TO BE LOCATED SUBDERMALLY AND NOT IN A VEIN. ANOTHER SUBSEQUENT ATTEMPT AT ACCESS WAS SUCCESSFUL, AND NO DIFFICULTIES WERE REPORTED AT THE NEW SITE.
H-6: CLARIFICATION OF EVAL CODE; METHODS, 86: 100X MAGNIFICATION. THE REPORTING FACILITY RETURNED TWO OPENED DEVICE SAMPLES. ONE SAMPLE APPEARED INTACT, AND EXAMINATION REVEALED NO NONCONFORMANCES. THE REMAINING SAMPLE EXHIBITED A CATHETER SEVERANCE. THE SEVERED PORTION OF THE TUBING WAS NOT RETURNED. MAGNIFICATION OF THE SEVERED CATHETER SHOWED: 26/32" OF THE TUBING REMAINED ATTACHED TO THE HUB WITH THE EYELET (WHICH SECURES THE TUBING INTO THE HUB) FOUND TO BE NORMAL AND INTACT. *THE EDGE OF THE ATTACHED TUBING APPEARS V-SHAPED AND JAGGED PORTIONS, INDICATING NUMEROUS PERFORATIONS WITH A SHARP, TAPERED OBJECT, SUCH AS AN IV NEEDLE. *PROTRUDING SECTIONS OF THE EDGE INDICATES THAT TENSION HAD BEEN APPLIED, CAUSING THE ALREADY PERFORATED TUBE TO SEVER. THE FACILITY INDICATED THAT THE INSERTION WAS A DIFFICULT ONE AND THAT THE DEVICE HAD NOT BEEN CORRECTLY PLACED INTO A VESSEL. RATHER, THE DEVICE HAD BEEN PLACED INTO A SUBDERMAL SPACE. THIS INCORRECT PLACEMENT WILL HAVE ACCOUNTED FOR DIFFICULT INSERTION AND THE INABILITY OF THE IV FLUIDS TO INFUSE PROPERLY. FROM DATA OBTAINED FROM THE SAMPLE EVALUATION AND FROM INFO RECEIVED FROM THE REPORTING FACILITY, IT HAS BEEN CONCLUDED THAT THE SEVERANCE WAS INDUCED BY THE IMPLEMENTATION OF IMPROPER PROCEDURE. ANY CATHETER WILL SEVER IF SUCH IMPROPER PROCEDURES ARE EMPLOYED DURING USE. INSTRUCTIONS, WHICH ACCOMPANY THE PRODUCT, ADVISE THE CUSTOMER TO AVOID REINSERTION OF THE INTRODUCER NEEDLE AS THIS MAY PERFORATE THE CATHETER TUBE AND LEAD TO A SUBSEQUENT EMBOLUS. THE FACILITY WILL BE ADVISED OF CO'S FINDINGS AND INSTRUCTED TO REVIEW PROPER INSERTION AND MAINTENANCE PROCEDURES.
WHILE TRANSFERRING RESIDENT FROM BED TO WHEELCHAIR, USING LIFT, RESIDENT FELL TO THE FLOOR STRIKING BACK ON LEGS OF LIFT AND COCCYX ON FLOOR.
THRESHOLD INCREASE DURING THE LEAD REVISION PROCEDURE THERE WAS BLOOD NOTED IN THE PACMAKER HEADER.
CONNECTOR DIMENSIONS AND SEALING RINGS OK.
NO DETAILS AVAILABLE. INFORMATION FROM LAWSUIT. NO PRIOR COMPLAINT DOCUMENTED.
A TWO YR OLD BOY SUFFERED 1ST AND 2ND DEGREE BURNS TO 65% OF HIS BODY. "ONE OF THE HOSP'S RESIDENTS TOLD CO TO THE PT STAYED AROUND FOUR DAYS IN THE EMERGENCY AREA." THE BOY WAS TRANSFERRED "TO THE INTENSIVE CARE UNIT ON THURSDAY THE 17TH." HE WRITES THAT THE SALES REP WAS REQUESTED, BY A PLASTIC SURGEON, TO COME IN AND GO WITH "THE NURSE ON DUTY TO APPLY THE PRODUCT. ON FRIDAY, THE 18TH HE RECEIVED A CALL FROM THE DR "SAYING THAT PRODUCT WORSEN THE BOY'S CONDITION TO THE EXTEND THAT HE MAY DIE." THEY ALSO ARE ASKING FOR PAYMENT OF THE TREATMENT. THE CHILD DIED ON SATURDAY, 10/19/96.
DATE SENT TO FDA: 11/15/96. COMPLAINT INVESTIGATION FOR REPORT NO G0336. LOT 5003-5117 6"X 8" WOUND DRESSING WAS MFG FROM HYDROGEL SHEET BATCH HYB0711-5003 ON 2/3/95 AT FACILITY. THE HYDROGEL SHEET MATERIAL WAS CUT INTO 6" BY 8" DRESSINGS, PACKAGED INTO HEAT SEALED FOIL POUCHES, BOXED AND SHIPPED TO THE STERILIZER. MIXING: BATCH HYB0711-5003 WAS MIXED ON 2/3/95. A REVIEW OF THE BATCH RECORDS SHOWS THAT THE CORRECT PROPORTIONS WERE CALCULATED, EACH WEIGHING WAS INITIALED BY THE OPERATOR AND CHECKED AND INITIALED BY THE SUPERVISOR. ALL STEPS OF THE MIXING PROCEDURE WERE DATED AND INITIALED BY THE OPERATOR AND INITIALED AS CHECKED BY THE SUPERVISOR. REQUIRED TESTS (PH % SOLIDS< VISCOSITY) WERE PERFORMED AND INITIALED BY THE TESTER AND INITIALED AS CHCKED BY THE SUPERVISOR. TEST RESULTS WERE ALL ACCEPTABLE. COATING: BATCH HYB0711-5003 WAS COATED (MADE INTO HYDROGEL SHEET) ON 2/7/95-2/9/95. IN-PROCESS TESTING, FINAL PRODUCT TESTING, AND BIOBURDEN TESTING RESULTS ALL WERE ACCEPTABLE. DOCUMENTATION: THE BATCH RECORD FOR HYB0711-5003 WAS REVIEWED AND APPROVED. THE COMPLETE BATCH RECORD IS ON FILE. CONVERSION: BATCH HYB0711-5003 HYDROGEL SHEET WAS CUT AND PACKAGED INTO GEL 6" BY 8" WOUND DRESSINGS AND WAS CERTIFIED BY THEM ON 5/4/95 AS COMPLYING WITH CURRENT PRODUCTION STANDARDS AND THE REQUIREMENTS OF SPECIFICATIONS. STERILIZATION: LOT 5003-5117 WAS STERILIZED ON 5/15/96 USING THE DOSE REQUIREMENTS DETERMINED BY AAMI VALIDATION STUDIES (MINIMUM OF 2.0 MRADS, MAXIMUM OF 4.5 MRADS). THE PROCESSING REPORT SHOWS THE STERILIZATION MET ALL THE REQUIREMENTS. DOCUMENTATION: THE MSI PROCESSING REPORT IS ON FILE. RETAINS: RETENTION SAMPLES FROM LOT #5003-5117 WERE EXAMINED AND APPEARED TO BE NORMAL. CONCLUSION: THE REVIEW OF ALL DOCUMENTATION FOR LOT 5003-5117 SHOWS NO DEVIATIONS OR EVENTS THAT COULD AFFECT THE PRODUCT OR CAUSE IT TO PERFORM CONTRARY TO ITS INTENDED USE.
ON FEBRUARY 26, 1998, THE LAWSUIT FILED AGAINST SAFESKIN CORP BY THE PLAINTIFF ALLEGING INJURIES RESULTING FROM EXPOSURE TO SAFESKIN PRODUCT(S) WAS DISMISSED. PRELIMINARY DISCOVERY & SALES TRACE REVEALED THAT SAFESKIN PRODUCTS COULD NOT HAVE POSSIBLY CAUSED THE PLAINTIFF'S INJURIES.
FACILITY REPORTED TO SALES REP THAT ONE OF THEIR PTS CONTRACTED A KELBSIELLA INFECTION FROM A STERILE CONTAINER INSTRUMENT SET. FACILITY REPORTED HAD SEVERAL WET SET INCIDENTS PRIOR TO THIS PT INFECTION. UNABLE TO DETERMINE DEFINITIVE RELATIONSHIP BETWEEN PT INFECTION AND DEVICE SYSTEM. MALFUNCTION IS OCCURRING AT OR BELOW THE FREQUENCY AND SEVERITY THAT ARE USUAL FOR THIS DEVICE.
IMMEDIATELY AFTER PLACEMENT OF CATHETER PT WENT INTO ANAPHYLACTIC SHOCK, REQUIRING MEDICAL INTERVENTION AND TRANSFER TO INTENSIVE CARE UNIT. CATHETER REMOVED IMMEDIATELY AND PT RECOVERED WELL AFTER RECEIVING BENADRYL AND EPINEPHRINE.
DATE SENT TO FDA: 11/15/96. CO HAS DECIDED TO DISCONTINUE MFG AND SALE OF SEVERAL BRANDS OF I.V. CATHETERS AS OF 9/18/96. IN SPITE OF RESEARCH DONE TO DATE, CO HAS NOT BEEN ABLE TO ESTABLISH CAUSALITY FOR THE TYPE OF EVENT REPORTED. CO WILL HOWEVER CONTINUE TO TRACK THIS TYPE OF INFO, AS IT IS IMPORTANT TO PRODUCT IMPROVEMENT AND DEVELOPMENT PROCESS.
NO STIMULATION. X-RAY INDICATES THAT THE LEAD IS CLAMPED BETWEEN THE FIRST RIB AND CLAVICLE "SUBCLAVIAN CRUSH".
CO RECEIVED INFO THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR "PHANTOM SENSING AND INHIBITED INAPPROPRIATELY."
DEVICE LABEL CODE FOR F10. POSITION 1: 1738, POSITION 2: 1738 AND POSITION 3: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL.
EVENT: POOR AUGMENTATION WAS NOTED DURING IABP. AN X-RAY TAKEN SHOWING THTA THE IAB WAS NOT IN THE PROPER POSITION. THE DR. WAS UNABLE TO ADVANCE THE IAB ANY FURTHER. THE CATHETER WAS TOO SHORT. THE IAB WAS REMOVED AND A SECOND IAB, A 50 CC BALLOON WAS INSERTED INTO THE PATIENT AND THERE WAS BETTER AUGMENTATION. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 10/2/96. THE IAB WAS INSERTED AT THE TIME OF ANGIOPLASTY AND A SHORT TIME LATER, POOR AUGMENTATION WAS NOTED. UNDER FLUROSCOPY, THE IAB APPEARED TO SHORT. APPROX. 16 HOURS LATER, THE IAB WAS REMOVED AND A 50CC. IAB WAS INSERTED. AUGMENTATION IMPROVED. IT WAS UNK IF THERE WAS ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. IT WAS REPORTED THAT HE DID EXPIRE. EVENT COMPLICATIONS: UNK - REPORTED 9/5/96 AND 10/2/96.
DR USED CATHETER TO DO FLUSH STUDY. A 4F PEDIATRIC SHEATH BY ANOTHER CO WAS USED IN RIGHT FEMORAL ARTERY. CATHETER PERFORMED FINE. UPON REMOVAL OF CATHETER THE TIP BUCKLED ONTO ITSELF AND KNOTTED UP. IN TRYING TO MANIPULATE THE CATHETER TO REMOVE THE TIP SEPARATED FROM THE CATHETER SHAFT. WENT IN WITH A SNARE AND WAS UNSUCCESSFUL. PT WENT TO SURGERY.
THE LOT HISTORY RECORD WAS REVIEWED FOR ANY ABNORMALITIES WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. THE LOT WAS MANUFACTURED AND PACKAGED TO SPECIFICATION AND PASSED ALL INSPECTIONS PRIOR TO RELEASE. NOTHING KNOWN TO HAVE CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. THE MANUFACTURING RELEASE DATE FOR THIS LOT WAS 8/21/95. SAMPLES FROM THIS LOT WERE PULL TESTED IN-PROCESS AND THE RESULTS FOR THIS LOT WERE: 5.40.6.10,7.65,7.00,6.85.7.55,5.80,7.35,7.20,5.406.35,6.25,5.85,6.00,5.55,6.80 ALL READINGS EXCEED THE IN-PROCESS MINIMUM SPECIFICATION OF 4 LB. SAMPLES FROM THIS LOT WERE ALSO TESTED FOR ELONGATION AND THE RESULTS WERE: 8.5,10,11.25,11,10.25,11.5,9.75,10.5,12,8,11,10,9.5,9.75,9,11.5, ALL READINGS EXCEEDED THE IN-PROCESS MINIMUM SPECIFICATION OF 4". THE TUBING UTILIZED FOR LOT 507818 WAS AS FOLLOWS: PART NUMBER RECEIVING NUMBER DESCRIPTION 01300301, 942612, 4F NYLON TUBING, 01000702, 921089, 4F SOFT TIP, A THIRTEEN PIECES RANDOM SAMPLE WAS PULL TESTED AT INCOMING. ALL OF THE READINGS WERE ABOVE SPECIFICATION. THE ACTUAL DATA AS FOLLOWS: RECEIVING NUMBER 942612 (9.5 MIN. SPEC) 11.33, 11.33,11.62,11.58,10.12,12.46,11.62,12.62,12.86,11.46,11.66,11.82,11.43,11.78, RECEIVING NUMBER 921089 (7.0 MIN. SPEC.) 10.87,10.37,10.59,9.96,10.07,10.01,10.46,9.32,10.57,10.36,9.92,9.84,9.90. CURRENT OPERATING PROCEDURES REQUIRE THAT EACH CATHETER MANUFACTURED BE INSPECTED FOR EACH OF THE FOLLOWING PARAMETERS (NOT INCLUSIVE OF ALL INSPECTION PARAMETERS): SHAFT, SHAPE, THRU-LUMEN AND DISTAL TIP I.D. THE MOST LIKELY CAUSE OF THE COMPLAINT IS IMPROPER USER HANDLING. IT IS KNOWN THAT THE DR ATTEMPTED TO REMOVE THE CATHETER FROM THE PT WITHOUT STRAIGHTENING THE TIP, AS CAUTIONED IN THE LABELING. THIS RESULTED IN THE TIP TANGLING INTO WHAT APPEARED TO BE KNOT. A GUIDEWIRE WAS INSERTED INTO THE CATHETER AND MANIPULATED IN AN ATTEMPT TO THEN STRAIGHTEN THE TIP SECTION, THE RESULT OF THIS ACTION WAS THE TIP SEPARATING FROM THE CATHETER SHAFT. DR HAS BEEN CONTACTED ABOUT THIS COMPLAINT AND HE STATED HE NORMALLY DOES NOT STRAIGTEN CATHETERS DURING WITHDRAWAL WITH A GUIDE WIRE, AS INDICATED IN THE CO'S LABELING, BUT NOW HE REALIZES THE IMPLICATIONS AND WILL NOW ALWAYS REMOVE THE HALO CATHETERS OVER A WIRE. NO FURTHER CORRECTIVE ACTION AT THIS TIME. FREQUENCY HAS NOT INCREASED NOR IS THE SEVERITY OF THIS EVENT GREATER THAN USUAL. H6 EVAL CODES HAVE NOT BEEN ENTERED PENDING THE RETURN OF COMPLAINT SAMPLE.
ON THE THIRD ATTEMPT, IN AN UNSPECIFIED SITE, DEVICE WAS SUCCESSFULLY PLACED. AS THE SITE WAS BEING DRESSED, ABOUT 2 MINUTES AFTER INSERTION, THE PT BECAME FLUSHED AND HIS EARS AND NECK WERE RED. THEN PT HAD EMESIS, BROWN IN COLOR; SWOLLEN LIPS; BODY ITCHING AND SLURRED SPEECH. IT WAS ALSO EXPLAINED THAT HE ALSO BECAME AGITATED AND INCONTINENT OF URINE WHICH WERE NOT USUAL BEHAVIORS. THE PT REMAINED CONSCIOUS AND ALERT BUT COLOR ASHENED AND BP DROPPED TO 78/50. THE DEVICE WAS IMMEDIATELY REMOVED AND 50 MG IV BENADRYL WAS GIVEN VIA AN EXISTING PERIPHERAL LINE. THE EMS CALLED. HIS BLOOD SUGAR WAS CHECKED TO BE 176 BEFORE HE WAS TRANSFERRED TO THE HOSP FOR 24 HR OBSERVATION. HE WAS RELEASED HOME THE NEXT DAY. THE PT HAD A SIMILAR DEVICE IN FOR 10 WEEKS AND IT WAS REMOVED, PRIOR TO THIS INSERTION, AFTER IT BECAME SLUGGISH.
DATE SENT TO FDA: 11/15/96. B4, F8, G4: MFR ALERT DATE. CODE #1926-ON LABEL, CODE #2489- ON LABEL, CODE #2195-ON LABEL. H6-ADD'L INFO: IN SPITE PF EXTENSIVE RESEARCH DONE TO DATE, CO HAS NOT BEEN ABLE TO ESTABLISH CAUSALITY FOR THE TYPE OF EVENT REPORTED. CO WILL HOWEVER CONTINUE TO TRACK HIS TYPE OF INFO, AS IT IS IMPORTANT TO PRODUCT IMPROVEMENT AND DEVELOPMENT PROCESS. FOR BUSINESS REASONS, CO HAS DECIDED TO DISCONTINUE MFG AND SALE OF SEVERAL BRANDS OF I.V. CATHETERS AS OF 9/18/96.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT REMOVAL. PT UNDERWENT AN UNSCHEDULED TREATMENT THE NEXT DAY. THERE WAS NO PT INJURY REPORTED.
DURING A DIALYSIS TREATMENT, THERE WAS NO WEIGHT LOSS REPORTED. THE PT REPORTEDLY UNDERWENT A SECOND, UNSCHEDULED TREATMENT. A MES (MEDICAL EQUIPMENT SVC) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 11/06/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED OL, INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD NOT MELTED. THE CONNECTOR ON THE END OF THE FUSE WAS BROKEN, BUT HELD IN PLACE BY THE PLASTIC FITTING, ALLOWING INTERMITTENT CONTACT TO BE MADE. THE DAMAGE TO THE CONNECTOR MOST LIKELY OCCURRED WHEN THE FUSE WAS INSTALLED ON 10/24/96 AS A PART OF THE UF PUMP THERMAL FUSE REPLACEMENT PROGRAM. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995 (10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THE DAMAGED THERMAL FUSE CONNECTOR CAUSED THE REPORTED INCIDENT. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY TAN DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS.
THE DR UNSCREWED THE CLEAR HEMOSTASIS VALVE ASSEMBLY FROM THE SHEATH HUB INSTEAD OF UNSCREWING JUST THE BLUE DILATOR. A LARGE AMOUNT OF BLOOD CAME FROM THE SHEATH. IABP CONTINUED WITHOUT ANY FURTHER PROBLEMS.
THE PRODUCT IN THIS EVENT WAS NOT RETURNED TO CO FOR EVALUATION. THE ITEM WAS DISCARDED. THE FILE IS CONSIDERED CLOSED. THIS FORM WAS COMPLETED BY THE MANUFACTURER.
DURING CIRCUMCISION CLAMP FELL OFF AS FORESKIN WAS CUT. MORE THAN NORMAL BLEEDING OCCURRED REQUIRING TWO SUTURES. THE THREADING THAT ALLOWS THE CLAMP TO BE TIGHTENED WAS APPARENTLY WORN, THEREFORE ALLOWING THE NUT TO SLIP.
USER REPORT SUSPECTED DEVICE FOR STACKING BREATHS AND CAUSING PNEUMOTHORAX IN PT. SEVERAL DAYS LATER, PT EXPIRED.
DEVICE RETURNED FOR REPAIR, USER REPORTED MEMBRANE PANEL SWITCHES NOT OPERATIONAL AND PRESSURE LIMITS 8-10 CMH20 HIGHER THAN SETPOINTS. INVESTIGATION REVEALED DEFECTIVE MEMBRANE PANEL, SOLENOID MANIFOLD OFF-CENTER, TIDAL VOLUMES LOW (BEYOND SPECIFICAITONS), AND IN NEED OF PREVENTATIVE MAINTENANCE. DEVICE APPEARED TO HAVE BEEN TAKEN APART (PARTICALLY), KNOBS WERE INCORRECTLY POSITIONED; AND APPEARANCE SUGGESTED ROUGH HANDLING. BREATH STACKING COULD NOT BE VERIFIED OR DUPLICATED.
INVESTIGATION CONDUCTED. DR CITES SURGICAL TRAUMA AS CAUSE FOR FAILURE. PATIENT IS A BRUXOR. THIS FILE IS CLOSED.THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.OTHER FAILED IMPLANTS FROM BOX D6: MODEL/CATALOG # 3310HL/3310HL, LOT #943532.
CUSTOMER CLAIMS AFTER RUNNING THE UNIT FOR TEN MINS, THE UNIT WILL START JERKING, THEN STOP.
THE DEVICE WAS REMOVED FROM THE PT PRIOR TO TRANSPORTING HIM TO THE EMERGENCY ROOM.
DATE SENT TO FDA: 11/15/96. B5- ADD'L DATA RECEIVED FROM THE USER FACILITY D1,D2,D3 CORRECTED DATA. CO HAS DECIDED TO DISCONTINUE MFG AND SALE OF SEVERAL BRANDS OF I.V. CATHETERS AS OF 9/18/96. IN SPITE OF RESEARCH DONE TO DATE, CO HAS NOT BEEN ABLE TO ESTABLISH CAUSALITY FOR THE TYPE OF EVENT REPORTED. CO WILL HOWEVER CONTINUE TO TRACK THIS TYPE OF INFO, AS IT IS IMPORTANT TO PRODUCT IMPROVEMENT AND DEVELOPMENT PROCESS.
INDIVIDUAL SUFFERED TYPE-I LATEX ALLERGY DUE TO FREQUENT CONTACT WITH LATEX MEDICAL GLOVES.
MEDWATCH FORM ISSUED TO COMPLY WITH FDA MEDICAL DEVICE REPORTING REQUIREMENTS. INVESTIGATION OF THE LATEX ALLERGY CLAIM COULD NOT BE CONDUCTED AS NO LOT NUMBER, PRODUCT NUMBER, OR SAMPLES WERE AVAILABLE. IT IS NOT KNOWN NOT CAN IT BE DETERMINED IF CO WAS RESPONSIBLE FOR THE EVENT. SEVERAL MFR'S HAVE BEEN NAMED IN THE LAWSUIT DUE TO THE INDIVIDUALS EXPOSURE TO MULTIPLE PRODUCTS.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.OTHER FAILED IMPLANTS FROM BOX D6: MODEL/CATALOG #5512HL/5512HL, LOT#943085
THE CUSTOMER REQUESTED THAT THE SYSTEM BE CHECKED OUT. DURING VISUAL EXAMINATION, CO DETERMINED THAT ENOUGH LIQUID OXYGEN COULD LEAK FROM THE CRACKED CONNECTING TUBES TO POTENTIALLY CAUSE A SERIOUS INJURY. THE CUSTOMER CONFIRMED THAT NO INJURY OCCURRED AS A RESULT OF THIS MALFUNCTION. CO'S SERVICE TECH ALSO REPORTED THAT FLOW CONTROL KNOB, FLOW CONTROL VALVE, AND FLOW INDICATOR WERE CRACKED, THE DIAPHRAGM WAS RUPTURED IN THE RELIEF ECONOMIZER VALVE, AND THE PNEUMATIC DEMAND DEVICE WAS OUT OF ADJUSTMENT. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. A REVIEW OF THE PRODUCT HISTORY RECORD INDICATES NO DISCREPANCIES IN THE MANUFACTURING PROCESS PER THE APPROVED DMR. A CORRECTIVE ACTION WAS IMPLEMENTED WHICH REPLACED THE CONNECTING TUBES WITH A MORE DURABLE MATERIAL ON UNITS MANUFACTURED AFTER SEPTEMBER 13, 1995.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT LOSS REPORTED. THERE WAS NO PT INJURY OR INTERVENTION REPORTED. AN MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 11/04/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED OL OHMS, INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTEIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED: PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. CUSTOMER CONTACTED: NO. SALES/SVC CONTACTED BY INVESTIGATOR: NO. TRAINING REQUIRED: NO.
THREE INCIDENTS IN WHICH SEPARATION OF THE TUBING/HAND PUMP OCCURRED DURING USAGE. NO BLOOD HAD BEEN INTRODUCED INTO THE SET AT THE TIME OF SEPARATION. NO PT COMPROMISE.
SECTION F COMPLETED BY CO. NO OTHER INFO IS AVAILABLE. TWO USED Y-TYPE BLOOD SOLUTION SETS WERE RETURNED FOR EVALUATION. BOTH SETS REVEALED THE TUBING WAS SEPARATED FROM THE DISTAL END OF THE PRESSURE PUMPS. THE PRODUCING PLANT HAS INCORPORATED A MONITORING PROGRAM FOR SOLVENT BOND STRENGTH AFTER STERILIZATION. THE PRODUCING PLANT ALSO PERFORMS A 100% LEAK TEST ON SETS PRODUCED WITH THE HAND PUMP. AN INCREASE IN THE SOLVENT DEPTH WAS IMPLEMENTED IN 7/96, LASTLY, TUBING DIMENSION TOLERANCES HAVE BEEN EVALUATED TO INCREASE THE ROBUSTNESS OF THE SOLVENT BOND.
INVESTIGATION CONDUCTED. DR CITES CHRONIC INFECTION AS CAUSE FOR FAILURE. PATIENT HAS DIMINISHED ORAL HYGIENE. THIS FILE IS CLOSED.THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE. OTHER FAILED IMPLANTS FROM BOX D6: MODEL/CATALOG #        LOT NUMBER3212HL/3212HL              9434534514HL/4514HL              965583
ACCOUNT REPORTS ONE INCIDENT IN WHICH APPROX DURING THE "MIDDLE OF THE OR CASE", THE TUBING ON THE RIGHT HAND SIDE OF THE CUFF SEPARATED. NO  COMPROMISE TO THE PT OR TH4E HEATH CARE PROVIDER, HOWEVER, REPORTER STATED "THERE WAS BLOOD EVERYWHERE." DUE TO BLOOD CONTATMINATION, CUFF DISCARDED. LOT NUMBER NOT IDENTIFIED. REPORTER ALSO ADDED, "I DON'T THINK THIS IS A LOT PROBLEM SINCE IT WAS ONE INCIDENT, BUT I THOUGHT YOU MIGHT LIKE TO KNOW."
SECTION F COMPLETED BY BAXTER. NOI OTHER INFO IS AVAILABLE. SAMPLE NOT AVAILABLE FOR EVALUATION.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS CAUSE FOR FAILURE. THIS FILE IS CLOSED.THE REPORTED EVENT IS OCCURRING AT A FREQUENCY AND SEVERITY THAT IS CONSIDERED USUAL FOR THIS TYPE OF DEVICE.
DURING A DIALYSIS TREATMENT, THERE WAS INSUFFICIENT WEIGHT LOSS REPORTED. A MES (MEDICAL EQUIPMENT SERVICE) TECHNICIAN EXAMINED THE MACHINE AND REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE. A REVIEW OF THE DTF HISTORY DOES NOT APPLY. A REVIEW OF THE CPF HISTORY FOR THIS SPECIFIC SERIAL NUMBER MACHINE IN THIS COMPLAINT DOES NOT INDICATE THAT THIS HAS BEEN A RECURRING CONDITION SINCE THIS MACHINE WAS RELEASED TO THE FIELD. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE MES FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE PART WAS RETURNED FOR INVESTIGATION ON 11/06/96. THE RETURNED THERMAL FUSE WAS CONNECTED TO AN OHM METER. THE METER SHOWED OL, INDICATING THAT THE FUSE WAS BAD. THE THERMAL FUSE WAS DISASSEMBLED AND IT WAS SEEN THAT THE WAX HAD MELTED. A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. TO HELP DETECT ULTRAFILTRATION PUMP THERMAL FUSE FAILURES AND TO VERIFY THE ULTRAFILTRATION SYSTEM INTEGRITY, IT IS RECOMMENDED IN THE OPERATOR'S MANUAL THAT AUTOTEST BE PERFORMED; PRIOR TO THE FIRST TREATMENT OF THE DAY, IF THE MACHINE HAS BEEN TURNED OFF, IF A PT WEIGHT DISCREPANCY IS DISCOVERED, OR AFTER ANY CLEAN, DISINFECT, ACID RINSE, OR RINSE FUNCTION (P. 3-19, VERSION 1995/10). THE OPERATOR IS ALSO INSTRUCTED TO PERFORM A KUF COMPARISON OF THE CALCULATED VALUE TO THE ACTUAL VALUE AFTER THE TREATMENT BEGINS. THIS VERIFIES THAT THE ULTRAFILTRATION RATE IS AS EXPECTED. HOWEVER, IF THE THERMAL FUSE FAILS AFTER THE TREATMENT. BEGINS, THERE IS NO ALARM AND THE TREATMENT COULD BE COMPLETED WITH INSUFFICIENT WEIGHT REMOVAL. THE ONLY INDICATION OF FAILURE AFTER TREATMENT BEGAN WOULD BE A DROP IN THE ULTRAFILTRATION RATE. IT IS CONCLUDED THAT THE FAILED THERMAL FUSE CAUSED THE REPORTED INCIDENT. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED: NO.
BALLOON LEAK; ALARM OF THE IAB CONSOLE AND BLOOD SEEN IN THE LINE BEFORE ALARM. BALLOON WAS REMOVED THERE WAS MUCH DIFFICULTY TO INSERT THE BALLOON. BALLOON WAS IN FOR 32 HRS BEFORE LEAK WAS NOTED.
ALL UNK INFO REQUESTED BUT NOT REC. SECTION F INFO PROVIDED BY MFG. SECTION H6 EVAL IN PROCESS.
THE DR UNSCREWED THE CLEAR HEMOSTASIS VALVE ASSEMBLY FROM THE SHEATH HUB INSTEAD OF UNSCREWING JUST THE BLUE DILATOR.  A LARGE AMOUNT OF BLOOD CAME FROM THE SHEATH. IABP CONTINUED WITHOUT ANY FURTHER PROBLEMS.
AFTER PLACING THE BALLOON IN THE PT THE RN EXPERIENCED A BALLOON RUPTURE, THE BALLOON WAS REPLACED WITH NO INCIDENT.
ALL UNK INFO REQUESTED BUT NO REC. SECTION F INFO PROVIDED BY MFG.
THE IAB DID NOT INFLATE. NO OTHER INFORMATION WAS AVAILABLE FROM THE CONTACT AT THIS TIME.
SECTION F WAS ALSO COMPLETED BY THE MANUFACTURER IF NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. DEVICE LABEL CODES: 1738. THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE COMPLETELY UNFOLDED. THE SHEATH WAS OBSERVED TO BE KINKED. LABORATORY EXAMINATION REVEALED NO DEFECTS IN THE RETURNED IAB. THE IAB FULLY INFLATED AFTER 2 CYCLES WHEN ATTACHED TO THE SYSTEM 90 IABP IN THE LAB. THE BALLOON SUBSEQUENTLY PUMPED SATISFACTORILY AT 80 & 160 BPM. NO ALARMS WERE TRIGGERED. PROBABLE CAUSE OF DIFFICULTY: THE EXACT CAUSE OF THE DIFFICULTY COULD NO BE DETERMINED BASED ON THE EXAMINATION AND THE EVENT DESCRIPTION. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED DIFFICULTY IN THE LAB. IN GENERAL, INFLATION DIFFICULTIES MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: THE PROXIMAL PORTION OF THE MEMBRANE REMAINED WITHIN THE SHEATH. THE BALLOON WAS PLACED TOO HIGH IN THE AORTIC ARCH OR IN THE SUBCLAVIAN ARTERY. THE BALLOON WAS PLACED SUBINTIMALLY. THE IAB FAILED TO COMPLETELY UNFOLD BECAUSE THE USER DID NOT INJECT AT LEAST 30CC. OF AIR AS ADVISED IN THE INSTRUCTION FOR USE. THE CATHETER KINKED WITHIN THE PT, POSSIBLY DUE TO A SEVERE VESSEL TORTUOSITY AND/OR PT MOVEMENT. THE CATHETER KINKED OUTSIDE THE PT. THE USER MAY HAVE NOT PROPERLY SECURED THE CATHETER AND Y- FITTING TO THE PT. MANIPULATION OF THE KINKED PORTION OF THE CATHETER COULD HAVE MINIMIZED THE RESTRICTION AND ALLEVIATED THE PROBLEM. THERE WAS A LOOSE  CONNECTION BETWEEN THE IAB AND THE PUMP OR BETWEEN THE PUMP AND THE SAFETY CHAMBER. CHECKING THESE CONNECTIONS MAY HAVE ALLEVIATED THE PROBLEM. HAVING THE OPPORTUNITY TO EXAMINE THE FOLDED BALLOON MEMBRANE MAY HAVE PROVIDED SOME ADDITIONAL INSIGHT INTO THE ENCOUNTERED DIFFICULTY.
A FIELD COMMUNICATION REPORT WAS RECEIVED FROM A DEALER WHO WAS PERFORMING AN INITIAL INSTALLATION OF A CO'S ANALGESIA GAS MACNINE WHICH SAID THAT "HE HAD SEEN 100% N2O FLOW." THIS INSTRUMENT IS DESIGNED TO DELIVER MIXED O2 AND N2O TO A DENTAL PT. WHEN O2 FLOW OR PRESSURE IS NOT PRESENT, THE INSTRUMENT HAS A FEATURE WHICH STOPS THE FLOW OF N2O. THIS FEATURE, THEREFORE, HAD MALFUNCTIONED. THE REPORTING SOURCE INDICATED THAT THIS WAS A NEW INSTALLATION WHEN HE WAS PERFORMEING THE SAFETY CHECKS AND NO PT WAS CONNECTED TO THE SYSTEM. THE UNIT WAS RETURNED FOR REPAIR AND WAS RECEIVED ON 8/19/96. CO HAD PREVIOUSLY SUBMITTED MDRS WHEN THE FAILSAFE HAS MALFUNCTIONED, EVEN WHEN ONLY IN A CO TEST AS IN THE CASE OF THI UNDER CURRENT MDR REGULATIONS, CO HAS DETERMINED THAT THIS CATEGORY OF PRODUCT MALFUNCTION DOES NOT REQUIRE SUBMISSION OF AN MDR AND HAS FILED AN EXEMPTION WITH THE FDA ON 11/6/96.
THE QUALITY DEPT, AS A MATTER OF POLICY, REVIEWS UNITS RETURNED FOR REPAIR, AND ALSO INVESTIGATES COMPLAINTS. THE SUBJECT COMPLAINT CONCERNS A MALFUNCTION CATEGORY PREVIOUSLY DEFINED AS REQUIRING THE FILING OF AN MDR. CO'S REGULATORY AFFAIRS REVIEW GROUP HAS REVIEWED ALL THE INFO THAT IS REASONBLY AVAILABLE IN A TIMELY MANNER AND DETERMINED NOT TO SUBMIT AN MDR. CO HAS DECIDED TO SUBMIT THIS MDR DETERMINATION TO THE FDA FOR REVIEW. THE REGULATORY AFFAIRS REVIEW GROUP'S DETERMINATION IS BASED ON A REVIEW THAT A MALFUNCTION WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECCUR. AS PROVIDED IN 21 CFR 803.16, THIS REPORT OR OTHER INFO RECORDED BY PORTER INSTRUMENT COMPANY INC. UNDER 21 CFR PART 803, DOES NOT NECESSARILY REFLECT A CONCLUSION BY PORTER THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE OR PORTER INSTRUMENT COMPANY INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT. PORTER NEED NOT ADMIT AND MAY DENY THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, PORTER INSTRUMENT COMPANY INC., OR EMPLOYEES THEREOF, CAUSED OR CONTRIBUTED TO AN EVENT. THIS ANALGESIA GAS MACHINE (FLOWMETER) WAS ORIGINALLY SHIPPED ON 5/24/96. DEVICE HISTORY RECORD FOR THIS UNIT SHOWS THAT IT HAS NEVER BEEN RETURNED FOR SERVICE/REPAIR SINCE ITS ORIGINAL SHIPMENT IN 1996. UPON RETURN TO CO THE FLOWMETER WAS EVALUATED BY ENGINEERING. IN THIS EVAL THE ORIGINAL CUSTOMER COMPLAINT OF N2O FLOW WITHOUT O2 COULD BE PRODUCED DURING THE SPECIFIC FAILSAFE SAFETY CHECK THAT IS PART OF THE EVALUATION PROCESS. THE UNIT WAS EVALUATED BY ENGINEERING ON 8/19/96. TEST PROCEDURE TO-102 PRODUCED THE REPORTED COMPLAINT OF N2O WITHOUT O2 EVENT USING THE EXTENDED DYNAMIC TEST AT 60 PSIG O2 BE A SEVERE TEST OF POPPET PERFORMANCE. IT IS ONE OF THE TESTS PERFORMED ON 100% OF THE NEW PRODUCTION UNITS. A COMPLETE DISASSEMBLY OF THE UNIT WAS THEN DONE, FOLLOWING THE SAME PROCEDURE THAT HAS BEEN DEVELOPED OVER THE COURSE OF EVALUATIONS OF OTHER FAILSAFE MALFUNCTIONS THERE WAS NO INDICATION OF VISIBLE DAMAGE TO THE UNIT. BASED UPON THE OBSERVATIONS MADE DURING THIS EXAMINATION, THE CAUSE OF MALFUNCTION WAS DETERMINED TO FALL UNDER THE INSUFFICIENT LUBRICATION CATEGORY. THE UNIT'S FAILSAFE BLOCK WAS REPLACED, RP-102 WAS PERFORMED (THE PROCEDURE FOR RECONDITIONING MXR FLOWMETERS) AND THEN IT WAS TESTED IN THE USUAL MANNER. CUSTOMER SERVICE SENT A REPLACEMENT FLOWMETER TO THE OFFICE, NO FURTHER ACTIONS ARE REQUIRED. CO CONCLUDES THAT PREVIOUS ACTIONS TO MINIMIZE FAILSAFE MALFUNCTIONS ARE STILL VALID AND THIS MDR EVALUATION DOES NOT LEAD TO ANY DIFFERENT CONCLUSION OR NEW ACTIONS. CO BELIEVES THAT UNDER SECTION 803.20(C), THIS CATEGORY OF MALFUNCTION IS EXEMPT FROM FUTURE MDR REPORTING AND HAS SUBMITTED AN MDR EXEMPTION REPORT TO THE FDA ON 11/6/96. CO WILL SUBMIT SIMILAR MDRS UNTIL IT IS NOTIFIED OTHERWISE BY THE FDA.
THIS PT  HAD AN OVERTUBE THROUGH WHICH AN ENDOSCOPE WAS INSERTED: FOR BAND PLACEMENT IN AN ATTEMPT TO LIGATE VARICES. AT THE END OF THE PROCEDURE THE OVERTUBE WAS WITHDRAWN AND THE UPPER PHLANGE SECTION OF THE TUBE SEPARATED FROM THE DISTAL TUBE PORTION. THIS TUBE QUICKLY MIGRATED DOWN THE GASTRIC SYSTEM. IT WAS EVENTUALLY REMOVED VIA A GASTRIC SNARE.
UNDERDELIVERY REPORTED. THE PUMP WAS IN HOME USE FOR TPN INFUSION. IT WAS SET TO INFUSE 1000ML OVER 10 HOURS WITH A ONE HOUR TAPER UP AND A ONE HOUR TAPER DOWN. THE PT REPORTED THAT THE DISPLAY INDICATED COMPLETE DELIVERY AT THE EXPECTED END INFUSION TIME, HOWEVER THE IV CONTAINER WAS STILL APPROX 1/2 FULL. THERE WERE NO ADVERSE PT EFFECTS. THE PUMP WAS SWITCHED OUT AND TPN THERAPY RESUMED THE NEXT DAY.
DEVICE PASSED ALL TEST PROCEDURES WITHIN PRODUCT SPECIFICATION.
A COMPETITOR'S IAB WAS REMOVED ON FRIDAY DUE TO A LEAK AND REPLACED W/ANOTHER IAB, WHICH ALSO WAS REMOVED AFTER 24 HRS OF USE DUE TO A LEAK. NO REPLACEMENT NECESSARY PT DOING WELL.
ALL UNK INFO REQUESTED BUT NOT REC. SECTION F INFO PROVIDED BY MFG. SECTION 6 EVAL IN PROCESS.
DURING A FISTULA PROCEDURE, THE CATHETER BALLOON RUPTURED AT 10-15 ATM & UPON REMOVAL OF THE CATHETER THE DISTAL TIP & BALLOON CAME OFF. A VEINOTOMY WAS PERFORMED & THE INDWELLING PIECE WAS REMOVED FROM THE PT . A COMPETITOR'S PRODUCT WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS BEING REPORTED.
THIS EVENT DOES NOT MEET THE CRITTERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS IT LIKELY TO IF THE EVENT WERE TO RECUR.
MD WAS PERFORMING ESOPH. LIGATION WITH CO'S BITE BLOCK & WHILE REMOVING SCOPE FOR ANOTHER BANDING, OVERTUBE FLANGE DETACHED FROM SHEATH WITH SHEATH REMAINING IN PT'S ESOPHAGUS. PT SENT TO ENDO FOR REMOVAL USING A SNARE WITHOUT ANY PT COMPLICATIONS. RN INDICATES UNK TIMES OVERTUBE USED.
#10 COULD NOT EVALUATE PRODUCT AS PRODUCT NOT RETURNED CONTRARY TO D9, CONFIRMED NO PRODUCT RETURNED AFTER REPEATED PHONE REQUESTS.
ON 11/12/96, THE MFR RECEIVED AN EXPLANT DATA FROM THE FACILITY WHICH STATES THAT THE DEVICE WAS EXPLANTED ON 11/5/96 DUE TO INFECTION. IT ADDITIONALLY STATES THAT THE DEVICE WAS SENT TO THE LAB ON 11/5/96 PER ORDER OF THE PHYSCICIANS. THE DEVICE WAS STATED TO HAVE BEEN IMPLANTED WITHIN THE ABDOMEN FOR USE IN THE PT'S THERAPY.
FURTHER COMMUNICATION WITH THE PHYSICIAN'S OFFICE, ON 11/19/96, REVEALED THAT THE DEVICE WAS REMOVED DUE TO INFECTION WHICH WAS NOT RELATED TO THE DEVICE OR A DEVICE MALFUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS THIS CATALOG AND LOT NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
REPORTER STATED THAT CALLER FROM ACCOUNT REPORTED THE PROGRAMMED VOLUME DISPLAY ON STATION 6 (YELLOW LEAD) IS MISSING THE TOP SEGMENTS OF THE LCD AND THE TOTAL DELIVERED DISPLAY IS MISSING THE LOWER SEGMENTS OF THE LCD. ALSO SOME OTHER LCDS ARE MISSING SEGMENTS INTERMITTENTLY. REPORTER HAD CALLER RUB HIS THUMB ACROSS THE AFFECTED DISPLAY -THE PROBLEM PERSISTED. THE USER WAS, ADVISED NOT ATO USE THE UNIT, BUT HE SAID HE WOULD CONTINUE TO USE IT UNTIL SWAP-OUT BECAUSE HE DID NOT FEEL IT IS AN ACCURACY ISSUE. UNIT WAS SWAPPED OUT 10/22/96.
SECTION F WAS COMPLETED BY CO BASED ON INFO RECEIVED FROM THE REPORTER. EVALUATION: THE UNIT WAS DIRTY AND WAS TESTED AS RECEIVED. IT PASSED ALL ACCURACY TESTS, HOWEVER DURING THE FIRST HOUR OF OPERATION, THE TOTAL DELIVERED DISPLAY HAD SOME FADED AND/OR MISSING SEGMENTS. THE COMPLAINT WAS CONFIRMED. AFTER APPROX ONE HOUR, THE UNIT OPERATED WITHOUT INCIDENT. UNIT WAS RELEASED TO REPAIR. A DEFECTIVE TOTAL VOLUME DISPLAY LCD WAS REPLACED. THERE WERE NO FURTHER PROBLEMS FOUND. THE UNIT HAS PASSED FINAL QA FINAL INSPECTION.
THE SUPPORT PERSON WAS PICKING UP THE PT VIA A WHEEL CHAIR GOING STRAIGHT DOWN THE HALL WITH THE POLE BEING PUSHED BEHIND THE CHAIR. AS THEY PUSHED THE PT THE 5 LEG POLE BECAME OFF BALANCE DUE TO THE POSITIONING OF THE PUMP ON TO THE POLE WHICH WAS PLACED ABOVE THE KNOB ON THE POLE. AFTER THE PUMP HIT THE PT'S HEAD THEY IMMEDIATELY APPLIED ICE TO THE AREA (OCCIPITAL). SHE SAID THE PT DENIED ANY HEADACHE AND THERE WERE NO LACERATIONS. THE PT SEEMED TO BE ALRIGHT. NEURO SIGNS UNCHANGED. PT DENIED ANY VISUAL DISTURBANCES. PT WAS MEDICATED WITH DEMEROL.
SECTION F COPIED FROM THE REPORT FROM THE CUSTOMER. THE DEVICE WAS UNSTABLE BECAUSE OF THE WAY THE PUMP WAS MOUNTED. ALL DEPTS USING POLES WERE NOTIFIED ABOUT THE CORRECT MANNER IN WHICH TO MOUNT ALL DEVICES.
LENSES WERE DISPENSED TO THIS 13 YR OLD PT IN JULY, 1996 ON A DAILY WEAR SCHEDULE. ON 10/1/96, THE PT SAW AN OPHTHALMOLOGIST WHO DIAGNOSED SERRATIA MARCESCENS KERATITIS IN BOTH EYES. SHE WAS PUT ON FML DROPS AND OCUFLOX (AN ANTIBIOTIC) WITH NO LENS WEAR. THE PROGNOSIS WAS THAT THE PT WOULD RECOVER WITH "TINY SCARS" THAT WOULD NOT AFFECT VISUAL ACUITY. THE PT WAS SEEN AGAIN ON 10/3 AND 8. THE OPHTHAMOLOGIST HAD THE LENSES ANALYZED AND A CONTAMINANT WAS IDENTIFIED THAT IS COMMONLY FOUND IN AIR CONDITIONING DUCTS AND CONTACT LENS SOLUTIONS. ON 10/18/96, THE DROPS WERE DISCONTINUED AND THE PT WAS TOLD SHE COULD TRY CONTACT LENSES AGAIN.
THIS REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR THE DEVICE OR WITH GREATER SEVERITY THAN IS STATED IN THE LABELING FOR THE DEVICE. CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFO UNLESS REQUIRED TO DO SO BY FDA. TSFZLY: ALL LENS PARAMETERS WITHIN SPECIFICATION. THE LENS HAD PROTEIN DEPOSITS. TSG47Y: ALL LENS PARAMETERS WITHIN SPECIFICATION. THE LENS IS SLIGHTLY DICOLORED.
EXPLANTATION OF SURGICAL MEMBRANE ORIGINALLY USED TO CORRECT ABDOMINAL VENTRAL HERNIA. SURGICAL MEMBRANE NOT MFG FOR ABDOMINAL HERNIA REPAIR.
A CORNEAL/SCERAL BURN OCCURRED DURING PHACO. PT HAD MARKED CONTRACTION OF CORNEA SCLERAL SLOT AND SUTURES WERE NEEDED TO CLOSE. DR DID NOT TEST FOR ASTIGMATISM AT THIS TIME.
H-10: A CO SVC REP CHECKED THE SYSTEM AND HANDPIECE S/N IUHP026080, AND FOUND THEM BOTH TO MEET THEIR PERFORMANCE SPECS. THERE WERE NO CONSUMABLES SAVED FOR EVAL. MISSING INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. H-11: SECTION F INFO WAS SUPPLIED BY UF. F-10:1757- LABELED; 2204 SHOULD BE 1422. THIS REPORT WAS MAILED IN TO FDA 11/13/96. DISCLAIMER THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MDR REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN CO PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS UNJURY.
WHEN THE BUTTON WAS PRESSED TO REQUEST A BOLUS PCA DOSE, THE PT REPORTEDLY REC'D "SLIGHT SHOCK FROM THE PT PENDANT CORD". RISK MANAGER STATES "IT WAS A VERY SLIGHT SHOCK WITH NO RESIDUAL ADVERSE EFFECT TO THE PT". THE  CLINICAL ENGINEERING DEPT REPORTS THE PT PENDANT WAS FRAYED AT THE POINT WHERE THE CORD ENTERS THE PENDANT JACK. THE PENDANT CORD WAS REPLACED AND THE OLD, DAMAGED CORD WAS DISCARDED. THE DEVICE THEN PERFORMED ALL TEST PROCEDURES WITHIN SPEC AND HAS SUBSEQUENTLY BEEN PLACED BACK INTO PT USE.
USER FACILITY CLINICAL ENGINEERING DEPT REPORTS VISIBLY DAMAGED, FRAYED BOLUS CORD. THE CORD WAS DISCARDED.
PORTION OF CATHETER BALLOON BROKE OFF DURING PROCDURE. BALLOON DID NOT FUNCTION PROPERLY. CATHETER REMOVED FROM PT, BALLOON FRAGMENT REMAINS IN PT. INVESTIGATION INITIATED, ONGOING. FINDINGS PENDING.
REPORTER STATED THAT USER FROM ACCOUT REPORTED THAT THE UNIT OVERFILLED ON 2 OCCASIONS, BOTH INVOLVING STATION 3. IN THE FIRST CASE, PROGRAMMED VOLUME WAS 1.49ML AND DELIVERED VOLUME DISPLAY READ 1.61 (8.05% DIFFERENCE). THE BAG WAS DISCARDED. IN THE SECOND CASE, THE UNIT APPARENTLY DELIVERED 1.36 ML INSTEAD OF 1.27 (7.09% DIFFERENCE). THIS BAG WAS USED BECAUSE THE ACCOUNT FELT THAT IT WAS ACCEPTABLE FOR THE PT INVOLVED. THERE WERE NO ALARMS IN EITHER INSTANCE. THE USER WAS ADVISED NOT TO USE THE UNIT, BUT HE STATED HE WOULD USE IT SINCE THEY ARE VERY CAREFUL WITH EACH TPN THEY COMPOUND. USER WAS REQUESTED TO SEND THE TRANSFER SET (LOT H96F10233R) WITH THE UNIT WHICH WAS SWAPPED OUT.
DURING PERIODONTAL SCALING DONE BY HYGENIST, PT EXPERIENCED SWELLING OF THE LIPS AND FACE. SUBSEQUENT PROCEDURES PERFORMED WITH VINYL GLOVES WITH NO ADVERSE REACTIONS.
OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE HEPARIN 12000 UNITS/250 ML SOLUTION AT 13 ML/HR. A NURSE REPORTS THAT WITHIN APPROX ONE HOUR, THE IV CONTAINER WAS EMPTY. THE DISPLAY INDICATED DELIVERY OF 25 ML. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. THE INFUSION WAS HELD FOR ONE HOUR AND THEN RESTARTED WITH A NEW PUMP. NO ADVERSE SEQUELAE WERE REPORTED.
THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE FREQUENCY OF OCCURRENCE FOR CODE 102 (OVERDELIVERY) FOR THE PRODUCT FAMILY DEATH AND SERIOUS INJURY COMPLAINTS IS APPROX .23/MILLION SETS.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FDA BY SIMS, INC. PURSUANT TO 21 C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUE AN ADMISSION BY THE CO THAT A SIMS DEVICE HAS MALFUNCITONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. NO REMEDIAL ACTION WAS TAKEN AS A RESULT OF THIS EVENT. CO TESTING HAS FAILED TO DUPLICATE DISLODGE CAUSED BY ANY PLAUSIBLE RANGE OF VENTILATOR PRESSURES AND CO IS UNABLE TO DETERMINE THE CAUSE OF THE COMPLAINT. THE MAJORITY OF USERS  HAVE NOT EXPERIENCED DISLODGE WHILE USING THIS DEVICE. CO DID INITIATE AN INCREASE IN THE DIAMETER OF ITS PEEP KEEP PLUG IN MAY 1996 IN RESPONSE TO PREVIOUS EVENTS; THIS CHANGE HAS NOT YET BEEN RELEASED IN THE FIELD. ADD'L DISCUSSION WITH HOSPITAL PERSONNEL REVEALED THAT AT LEAST ONE INCIDENT OF THE SWIVEL ADAPTER PEEP KEEP PLUG DISLODGE (PT UNK) OCCURRED WHILE THE PT WAS BEING MOVED. CO HAS NOT DETERMINED THE CAUSE OF THIS EVENT. BASED ON THE ABOVE INFO, CO HAS DETERMINED THAT AN EXTERNAL FORCE ON THE PEEP KEEP PLUG IS ONE POSSIBLE FAILURE MODE.
THE PROCEDURE WAS CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT, TRABECULECTOMY RIGHT EYE. THE SURGEON NEEDED TO PERFORM A VITRECTOMY. THE MACHINE WAS NOT WORKING TO THE SURGEON'S EXPECTATIONS. THE SURGEON FELT THE MACHINE DID NOT HAVE ENOUGH SUCTION. AFTER SOME PERIOD OF TIME, A NURSE OBSERVED THE MACHINE WAS ON PANEL CONTROL AND WHEN PLACED ON SURGEON CONTROL, THE MACHINE WORKED PROPERLY. HOSP WAS INFORMED DURING POST-OP PHONE CALL THAT THE PT HAS NO VISION IN RIGHT EYE.
LEAKAGE FROM CATHETER PRESENT UPON FLUSHIN TO WHITE LUMEN. RED LUMEN RESOLVED LEAKAGE. APPEARS TO HAVE CRACKED GROSHONG CATHETER. BETWEEN INSERTION AND EXIT SITES. REFERRED TO SURGERY FOR REMOVAL OF CATHETER. SURGEON DID NOT REMOVE CATHETER. TOLD TO USE IT.
REPORT REC'D FROM INTERNATIONAL AFFILIATE (AUSTRIA) INDICATES: "MEASURED DELIVERY AMOUNTS DIFFER FROM SET DELIVERY RATES (100 ML/HR 500 ML/HR, 900 ML/HR). BY 16% 17.2% AND 17.1%." REPORT INDICATES "UNK IF PT WAS CONNECTED AT THE TIME OF INCIDENT". THE REPORT ORIGINATED FROM A MEDICAL TECHNICAL CENTER. NO REPORT OF ANY PT EVENT HAS BEEN REC'D.
DEVICE INFO RECEIVED FROM AFFILIATE AS FOLLOWS: REPORTED EVENT COULD NOT BE CONFIRMED.
PT DC'D FOM HOSP TO START AB THERAPY WITH CATHETER RT SINGLE LUMEN. CATHETER LEAKING SEROUS/SANGUINOUS DRAINAGE FROM EXIT SITE. UNABLE TO FLUSH CATHETER UPON INSPIRATION. ABLE TO FLUSH WITHOUT EXPIRATION. EXIT SITE HARD AND TENDER. PT DR WAS CALLED AND PT RETURNED TO HOSP AT ER.
HEATER WOULD NOT HEAT HIGHER THAN 30 DEGREES. RPTR TRIED EVERYTHING BUT NOTHING CHANGED. RPTR CALLED 1-800 HELP LINE AT 1500 BUT THERE WAS NO TECH THERE TO HELP. GAVE RPTR AN 800 # THAT WOULD TRANSFER TO A BEEPER. RPTR CALLED THAT NUMBER AT AROUND 1520. STILL NO RETURN CALL AT AROUND 1700. RPTR CALLED THE 800# HELP LINE AGAIN AND THEY TOLD HIM ALL THE PEOPLE WHO HANDLE THAT MODEL HAD LEFT FOR THE DAY.
ON 9/30/96, THE ACCOUNT RECEIVED ERRATIC BHCG RESULTS WHILE RUNNING THE ANALYZER. AN INITIAL RESULT OF 15.4 MIU/ML WAS OBTAINED FROM A BARCODED ALLOQUOT TUBE. THE CUSTOMER REPEATED THE PT SAMPLE WITH A MANUAL 1:2 DILUTION AND RECEIVED A RESULT OF 628 MIU/ML. THE CUSTOMER THEN REPEATED THE SAMPLE STRAIGHT AND RECEIVED A RESULT OF 643 MIU/ML. NO ERROR CODES WERE SEEN WITH ANY OF THE RESULTS. NO REPORT OF INJURY.
INVESTIGATION SUMMARY: THE EVENT REPRESENTED IS NOT ADDRESSED IN THE DEVICE LABELING. A MALFUNCTION DID OCCUR. THIS REPORTABLE MDR EVENT WAS INVESTIGATED AS PART OF AN ONGOING STUDY OF THE AXSYM SYSTEM BY ABBOTT INTO THE CAUSATIVE REASON FOR MALFUNCTIONS. RESULTS OF THE INVESTIGATION YIELDED A NUMBER OF SYSTEM ENHANCEMENTS IMPLEMENTED ON CUSTOMER UNITS. IMPROVEMENTS INCLUDED AXSYM SYSTEM SOFTWARE VERSION 3.0 WITH ENHANCED ALGORITH FOR FLUID DETECTION, NEW BUFFER TUBING AND SEAL FITTINGS WHICH REDUCED BUBBLES FORMING IN TUBING LINES, MODIFICATIONS TO THE LIQUID LEVEL SENSE BOARD TO DECREASE SENSITIVITY OF THE INSTRUMENT TO ELECTROSTATIC DISCHARGE, AND PACKAGING MODIFICATIONS FOR ADDED PROTECTION TO PROBES. IN ADDITION, ABBOTT HAS EMPHASIZED TO OUR CUSTOMERS THAT CORRECT OPERATING PROCEDURES MUST BE FOLLOWED TO ENSURE OPTIMAL PERFORMANCE OF THE AXSYM SYSTEM. AREAS THAT WERE EMPHASIZED INCLUDED PROBE CRASH RECOVERY PROCEDURE, RECOMMENDED TUBE SIZES AND TYPES, OPENING REAGENT BOTTLE 4, PROPER LOADING/UNLOADING OF REAGENT PACKS, AND ENSURING PROPER SAMPLE AND REAGENT HANDLING. THIS IS THE FINAL REPORT.
CATH IMPLANTED AT ANOTHER FACILITY DID NOT WORK. WAS IN WRONG POSITION.
APPROX 12 WKS AFTER CATHETER PLACEMENT, DURING AN INFUSION OF CHEMOTHERAPY, THE PT COMPLAINED OF PAIN. ON 10/2/96, THE CATHETER WAS REMOVED AND A SLIT WAS NOTED IN THE CATHETER. IT WAS REPORTED THAT THE SLIT WAS IN THE CLAVICLE-FIRST RIB "PINCH-OFF" AREA.
THE CATHETER WAS BROKEN IN 2 PIECES AT THE PROXIMAL END OF THE CUFF. THE PROXIMAL HALF OF THE CATHETER INCLUDED THE PROXIMAL AND DISTAL LUMEN LEGS. THE DISTAL HALF OF THE CATHETER INCLUDES THE PROXIMAL AND DISTAL LUMEN LEGS. THE DISTAL HALF OF THE CATHETER INCLUDES THE CUFF. THERE WAS A KINK IN THE CATHETER BODY APPROX 5" PROXIMAL TO THE DISTAL TIP, BETWEEN THE 2ND AND 3RD DEPTH MARKS. AT THE KINK, THE TUBING HAD BEEN COMPRESSED AND WAS PERMANENTLY FLATTENED. THERE WAS A SMALL SLIT IN THE TUBING WALL AT THE KINK. BLOOD RESIDUE WAS CONCENTRATED INSIDE THE LUMEN BEHIND THE SLIT. TACTILE EXAM OF THE CATHETER SHOWED TENSILE WEAKNESS AT THE KINKED SITE IN THE MIDDLE OF THE DISTAL SEGMENT. THE CATHETER WAS FLUSHED THROUGH BOTH LUMENS IN BOTH HALVES AND ALL LUMENS WERE PATENT. THE DISTAL LUMEN IN THE DISTAL SEGMENT LEAKED THROUGH THE DISTAL VALVE AND THE SLIT IN THE CATHETER BODY. THE OTHER LUMENS WERE PRESSURIZED BY OCCLUSION AND DID NOT LEAK. A HIGH-CONTRAST BLUE DYE WAS FLUSHED THROUGH THE LUMEN TO HIGHLIGHT THE SPLIT AREA AND THE CATHETER WAS EXAMINED UNDER MAGNIFICAITON. THE SPLIT WAS APPROX 2-3 CM LONG RUNNING WITH THE LENGTH OF THE TUBING. THE CTR OF ONE SIDE OF THE SPLIT WAS COLLAPSED, AND DIPPED DOWN TO EXPOSE THE CROSS SECTION OF THE TUBING WALL. THE SPLIT EDGE SURFACE TEXTURE WAS DULL AND GRANULAR, BUT EVEN. THE TUBING OUTER DIAMETER AROUND THE SPLIT WAS WORN AND DULL. THE TUBING HAD TAKEN A FLATTENED SHAPE AT THE KINK. IT HAD BEEN COMPRESSED ON EITHER SIDE OF THE SPLIT, GIVING IT A "BOTTLE-NECK" APPEARANCE. THE EXTERIOR HAD BEEN RUBBED OR SCUFFED AT THIS LOCATION. DIAGONAL STRIATIONS THAT ARE PARALLEL TO EACH OTHER COULD BE SEEN ALONG THE TUBING BODY AT THE SPLIT SITE. THERE WAS A DULL STRIP WORN ALMOST PARALLEL ABOVE THE SPLIT. THERE WAS A SIMILAR ROUGH LINE IN THE BLUE STRIP ON THE SIDE OPPOSITE THE SPLIT.  ALL OF THESE SIGNS INDICATED DAMAGE COMMON TO CLAVICLE/FIRST RIB COMPRESSION. A COMPLICATION ASSOCIATED WITH THE MEDIAL PLACEMENT OF THE CATHETER IN THE SUBCLAVIAN VEIN. SINCE DUAL LUMEN TUBING, IS MORE RESISTANT TO FRACTURE AND SPLITS AND TEARS ARE COMMON, THIS IS A RISK AGAINST WHICH THE MFR WARNS THE USER IN THE INSTRUCTIONS FOR USE OF THIS PRODUCT.
THE USER RECEIVED AN ELECTRICAL SHOCK WITH TINGLING IN LEFT THUMB, WHILE APPLYING THE ELECTROCAUTERY FORCEPS TO THE PT. NO MEDICAL INTERVENTION WAS NECESSARY.
THE PT EXPERIENCED AN ABRASION TO THE INNER ASPECT OF THE ELBOW DURING AN ATTEMPT TO START AN IV. ON EXAMINATION A LARGE "HOOK" ON THE END OF THE NEEDLE WAS NOTED. NO TREATMENT WAS REQUIRED FOR THIS ABRASION AND ANOTHER VENIPUNCTURE WITH ANOTHER CATHETER WAS SUCCESSFUL.
A REVIEW OF MANUFACTURING WORK ORDER/INSPECTION RECORDS WAS CONDUCTED. NO SUCH DEFECTS WERE FOUND ON ANY OF THE SAMPLES INSPECTED DURING MFR OR PRIOR TO FINAL RELEASE. VISUAL EXAMINATION OF THE RETAINED SAMPLES DID NOT HIGHLIGHT ANY PROBLEMS. A NUMBER OF CORRECTIVE ACTIONS HAVE BEEN PUT IN PUT IN PLACE TO IMPROVE THE QUALITY OF THE PRODUCT AND PREVENT NEEDLE DAMAGE DURING MFR.
RESIDENT WAS FOUND ON THE FLOOR, LYING PRONE, AT THE FOOT OF HER BED. HER BED CHECK ALARM WAS NOT SOUNDING AND IT WAS NOT "ON HOLD". RESIDENT WAS ADMITTED TO THE HOSP WITH A DIAGNOSIS OF A RIGHT FRACTURE.
DEVICE WAS USED TO STABILIZE A BONE. PT WAS SUFFERING FROM CONTINUOUS SWELLING. X-RAYS WERE TAKEN AND IT REVEALED EXTREME RESORPTION OF METATARSAL HEAD SECONDARY TO THE USE OF THE DEVICE.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FDA BY SIMS, INC. PURSUANT TO 21 C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AN ADMISSION BY THE CO THAT A SIMS DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. NO REMEDIAL ACTION WAS TAKEN AS A RESULT OF THIS EVENT CO TESTING HAS FAILED TO DUPLICATE DISLODGE CAUSED BY ANY PLAUSIBLE RANGE OF VENTILATOR PRESSURES AND CO IS UNABLE TO DETERMINE THE CAUSE OF THE COMPLAINT. THE MAJORITY OF USERS HAVE NOT EXPERIENCED DISLODGE WHILE USING THIS DEVICE. CO DID INITIATE AN INCREASE IN THE DIAMETER OF ITS PEEP KEEP PLUG IN MAY 1996 IN RESPONSE TO PREVIOUS EVENTS; THIS CHANGE HAS NOT YET BEEN RELEASED IN THE FIELD. ADD'L DISCUSSION WITH HOSPITAL PERSONNEL REVEALS THAT AT LEAST ONE INCIDENT OF THE SWIVEL ADAPTER PEEP KEEP PLUG DISLODGE (PT UNK) OCCURRED WHILE THE PT WAS BEING MOVED. CO HAS NOT DETERMINED THE CAUSE OF THIS EVENT. BASED ON THE ABOVE INFO, CO HAS DETERMINED THAT AN EXTERNAL FORCE ON THE PEEP KEEP PLUG IS ONE POSSIBLE FAILURE MODE.
SILICONE BREAST PROSTHESIS WERE RUPTURED AND HAD TO BE REMOVED AND CAPSULECTOMIES PERFORMED AND A MASTOPEXY PERFORMED. THE PT ALSO SUFFERED A PNEUMOTHORAX.
THE STRIP GAVE A READING OF 30 POINTS BELOW PT'S ACTUAL BLOOD GLUCOSE. THE PT HAD TO BE HOSPITALIZED. THE PHARMACIST COMPARED BLOOD GLUCOSE USING CO'S STRIP WITH ANOTHER CO'S STRIP. CO STRIP GAVE INACCURATE GLUCOSE READING.
AFTER PLACING TWO STENTS, THE GUIDE WIRE MOVED BACKWARD. AS THE WIRE WAS REPOSITIONED, A PERFORATION OCCURRED. THE PT WENT TO SURGERY. PT STATUS IS LISTED AS "OK".
THE GUIDEWIRE HAS BEEN DISCARDED BY THE HOSPITAL, SO NO RETURNED PRODUCT ANALYSIS WILL BE AVAILABLE.
DURING A POST STENT PROCEDURE, THE WIRE CROSSED THE THROMBUS IN THE STENT AND THE PT BEGAN EXPERIENCING COMPLICATIONS. THE PT WENT TO SURGERY. DURING SURGERY THE SURGEON DISCOVERED A VESSEL PERFORATION. PT STATUS IS LISTED AS "OK".
THE GUIDE WIRE HAS BEEN DISCARDED BY THE HOSPITAL, SO NO RETURNED PRODUCT ANALYSIS WILL BE AVAILABLE.
PUMP MALFUNCTION. CONTINUOUS BEEPING NOTED. ERROR DETECTED ON SCREEN. PUMP WILL NOT FUNCTION. PT MISSED DOSE OF ANTIBIOTIC AND WAS RESTARTED WITH NEW PUMP.
11/4/96-HEALTH AIDE TRANSFERRINGG PT FROM HOSP BED IN HOME TO W/C WITH PT'S HYDRAULIC LIFT. LIFT FALLS FORWARD WITH PT IN CRADLE DROPPING PT TO FLOOR, LIFT THEN TOPPLES ON ITS SIDE. AIDE MAKES REPEATED INQUIRIES INTO PT'S CONDITION TO WHICH PT REPLIES "I'M NOT HURT". PT'S SISTER COMES INTO BEDROOM FROM KITCHEN, BOTH PT AND SISTER DISCUSS "CHILDREN PLAYING WITH LIFT THIS WEEKEND" AND "NOT LETTING KIDS PLAY ON EQUIPMENT." AIDE REPORTS FALL TO SUPERVISOR AT OFFICE LETTING SUPERVISOR KNOW THERE ARE NO APPARENT INJURIES. NURSE MAKES HOME VISIT ON 11/6/96, PT COMPLAINS OF PAIN AND SWELLING LEFT KNEE. NURSE AND FAMILY AGREE TO TRANSPORTING PT TO ER. PT ADMITTED WITH FRACTURED LEFT FEMUR. 11/8/96-SUPERVISOR AND A NURSE INSPECT PT'S HYDRAULIC LIFT. NO APPARENT DEFECT NOTED WITH PT'S EQUIPMENT. IT WAS DETERMINED THAT A POTENTIAL EXISTS FOR PROBLEMS INVOLVING LIFT IF CHAINS TO SLING WERE NOT PLACED CORRECTLY.
DEVICE WAS USED DURING A LAPAROSCOPIC GASTRECTOMY BYPASS. IT WAS REPORTED BY THE REP AFTER FIRING THE STAPLER THERE WAS BLEEDING FROM THE STAPLE LINE 3 TIMES. IT WAS COMPLETED BY OPEN SURGERY WHERE STAPLE LINES WERE OVERSEWN.
D5;H4: INFORMATION UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION. H6; EVALUATION CODE #100(OTHER): NICK ON KNIFE BLADE. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY PRODUCED "STAPLE LINE BLEEDING" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND WAS FOUND TO HAVE A NICKED KNIFE. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
RUPTURED SILICONE IMPLANT, LEFT BREAST WITH DEFORMITY AND CONTRACTURES OF BOTH BREASTS. NO IDENTIFICATION INFO NOTED ON EXPLANTED IMPLANT.
CO WAS NOTIFIED BY AN OPHTHALMOLOGIST OF TWO WOMEN WHO DEVELOPED ENDOPHTHALMITIS AFTER IMPLANTATION OF UV-ABSORBING SILICONE LENS, MODEL 920. SPECIFIC INFO AS TO TREATMENT OR SURGICAL INTERVENTION WERE UNKNOWN AT OF THE INITIAL REPORT. ADD'L INFO AS TO EVAL OF THE ENDOPHTHALMITIS, TREATMENT AND OUTCOEM ARE BEING  SOUGHT FROM THE OPHTHALMOLOGIST. MFR INVESTIGATION OF THE BATCH RECORDS WAS PERFORMED, ALL ACCEPTANCE CRITERIA WAS MET. LAB REPORTS WERE REINSPECTED AND NO DISCREPANCIES NOTED, AND ALL RELEASE CRITERIA WAS MET IN CONCLUSION, THE PRODUCT IS NOT RESPONSIBLE FOR ENDOPHTHALMITIS.
PT RECEIVING DOBUTAMINE IN THE HOME. PUMP MALFUNCTIONED KEYPAD CHECK. THEN ERROR DETECTED, AND PUMP WOULD NOT FUNCTION. LUCKILY ANOTHER PUMP WAS ALREADY IN PT'S HOME SO PT DIDN'T MISS HER DOSE OF DOBUTAMINE.
OPEN CAPSULOTOMY WITH REMOVAL OF RUPTURED LEFT IMPLANT.
PT WAS HAVING AN ANGIOGRAPHIC EVALUATION FOR STENOSIS OF AN AV DIALYSIS SHUNT. AT THE END OF THE PROCEDURE, AFTER THE ANGIOPLASTY OF THE SHUNT, WITH A PTA CATHETER THE CATHETER WAS BEING REMOVED. THIS WAS DONE WITH NO EXCESSIVE FORCE. THE REPEAT ANGIOGRAM AT THIS TIME REVEALED A SMALL FILLING DEFECT WITH ASSOCIATED RADIO-OPAQUE MARKERS WITHIN THE PROXIMAL PORTION OF THE GRAFT LIMB. THE DISTAL AND BALLOON TIP OF THE CATHETER HAD BROKEN OFF. IMMEDIATE INTERVENTION WITH A BASKET RETRIEVAL CATHETER WAS PERFORMED AND REMOVED THE DISTAL END OF THE CATHETER. HOWEVER, THE BALLOON TIP WAS NOT PRESENT. A SURGICAL CONSULT WAS OBTAINED, PT. TAKEN TO OR AND THE BALLOON TIP REMOVED.
THIS EVENT DOES NOT MEET CRITERIA OF A REPORTABLE EVENT UNDER THE REGULATIONS AS DEATH OR SERIOUS INJURY DID NOT OCCUR NOR IS LIKELY TO IF THE EVENT WERE TO RECUR. BLOCK B2,D1,D2,D3,D9,E1, & E3 WILL BE DIFFERENT FROM THE USERS VOLUNTARY REPORT. NAME OF THE MFR ISN'T CORRECT & THE INCIDENT INFO WAS REPORTED BY A DIFFERENT INDIVIDUAL.
THE ACETABULAR INSERT WOULD NOT SEAT IN THE SHELL. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
SUMMARY OF EVAL: AS RECEIVED, THE RETURNED INSERT IS OBSERVED TO BE IN GOOD CONDITION EXCEPT FOR A GOUGE ON THE OUTER SURFACE OF THE INSERT. VISUAL INSPECTION OF THE RETURNED INSERT SHOWS THE GOUGE HAS DAMAGED FIFTY PERCENT OF THE DECAGON ON THE INSERT OUTER SURFACE. THIS CONDITION WOULD SUGGEST THAT THE INSERT WAS NOT ALIGNED PROPERLY DURING INSERTION INTO THE METAL SHELL. THE DAMAGED DECAGON ON THE INSERT OUTER SURFACE WOULD RESTRICT THE INSERT FROM SEATING PROPERLY IN THE MATING METAL SHELL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE. THE EVAL RESULTS SUGGEST THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE BUT RATHER WOULD BE RELATED TO ALIGNMENT DURING INSERTION OF THE INSERT INTO THE METAL SHELL.
REPORT OF AN UNDERDELIVERY. THE ACCOUNT IS CONDUCTING A STUDY WHICH REQUIRES THAT 200ML OF THE DRUG BE DELIVERED IN 30 MINUTES. THE PUMP WAS SET AT 400M PER HOUR. THE UNDERDELIVERY VARIED CC PER HOUR TO 130 CC PER HOUR. TWO PTS HAD TO BE DROPPED FROM THE STUDY DUE TO THIS INACCURACY. IT APPEARED TO BE A LOT SPECIFIC PROBLEM BECAUSE WHEN NEW SETS WERE USED FROM A DIFFERENT LOT, THEY DID NOT HAVE THIS DIFFICULTY. NO ADVERSE PT REACTION WAS REPORTED.
THERE HAVE BEEN NO MULTIPLE REPORTS ON THIS LIST AND LOT#.
DURING A RENAL ARTERY BALLOON PTA AND STENT PLACEMENT, USING A 15MM LONG STENT WITH A 6MM DIAMETER BALLOON, THE BALLOON RUPTURED IN SITU. THE BALLOON CATHETER WAS CAREFULLY WITHDRAWN INTO THE GUIDING CATHETER AND BOTH THE GUIDING CATHETER AND BALLOON CATHETER WERE THEN REMOVED. 50% OF BALLOON MATERIAL WAS MISSING UPON IMMEDIATE CATHETER INSPECTION. RESULTED IN EMBOLIC OCCLUSION OF AN INFRA RENAL BRANCH ARTERY AND SUBSEQUENT INFARCTION OF APPROX 15% OF THE RENAL PARENCHYMA.
CO WAS NOTIFIED BY AN OPHTHALMOLOGIST OF 2 WOMEN WHO DEVELOPED ENDOPHTHALMITIS AFTER IMPLANTATION OF THE UV-ABSORBING LEAVE IN LENS. ONE WOMAN HAD A CATARACT EXTRACTION (LEFT EYE) AND IMPLANT OF THE MODEL 920 IOL ON 9/30/96. ONE DAY POSTOPERATIVE EXAM BY SLIT LAMP REVEALED 2+ CELLS AND 1+ FLARE. A DIAGNOSIS OF ENDOPHTHALMITIS WAS MADE AND A VITRECTOMY PERFORMED ON 10/4/96. THE LEFT EYE WAS PATCHED, ANTIBIOTICS STARTED,     AND SHE WAS HOSPITALIZED FOR 24 HRS. THE DR'S CALL WAS PROMPTED BY A REQUEST FOR INFO AS TO THE OCCURRENCE OF ENDOPHTHALMITIS. BOTH EYE IMPLANTS WERE DONE WITHIN 2 WKS OF EACH OTHER AT DIFFERENT LOCATIONS, AND DIFFERENT INSTRUMENTS WERE USED IN EACH CASE. THE ONLY COMMON FACTOR WAS THE UV-ABSORBING LENS, MODEL 920. FOLLOW-UP INFO IS BEING SOUGHT AS WELL AS THE OUTCOME OF THE ENDOPHTHALMITIS. MFR INVESTIGATION OF THE BATCH RECORDS WAS PERFORMED. ALL ACCEPTANCE CRITERIA WAS MET; LABORATORY REPORTS WERE REINSPECTED AND NO DISCREPANCIES NOTED; ALL RELEASE CRITERIA WERE MET AND TOXICITY STUDIES FURTHER SUPPORT THAT THE PRODUCT IS NOT RESPONSIBLE FOR THE ENDOPHTHALMITIS.
IT WAS REPORTED THAT THE DISPLEYED VOLUME TO BE INFUSED (VTBI) AMOUNT WAS INCREASING INSTEAD OF DECREASING DURING THE INFUSION. REPORTEDLY THE VTBI WAS SET AT 30ML WITH A RATE OF 10 ML/HR, AND A FEW HOURS LATER THE VTBI DISPLAYED 297 ML. NO PT INJURY WAS REPORTED. THE AMOUNT OF SOLUTIONS DELIVERED TO THE PT WAS NOT REPORTED.
SECTION F COMPLETED BY THE MFR. EVALUATION SUMMARY: FLOW ACCURACY TESTINFG WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION. THE DISPLAYED VTBI AMOUNT DECREASED APPROPRIATELY DURING THE TESTING.
PT HAD CATARACT EXTRACTION WITH INSERTION OF INTRAOCULAR LENS IN 1978. PT PRESENTS WITH PSEUDOPHAKIC BULLOUS KERATOPATHY FOR EXCHANGE OF INTRAOCULAR LENS.
USER REPORTS PUMP TOTALIZER DOES NOT CORRESPONDING WITH AMOUNT DRAWN FROM SYRINGE-UNDERINFUSION.
MFR'S PRELIMINARY COMMENTS: INITIAL OBSERVATIONS CANNOT CONFIRM THE ABOVE. ALTHOUGH TESTS ARE CONTINUING. FREQUENCY OF OCCURRENCE STATEMENT. THESE ARE ON THE DEVICE. SEVERITY OF OCCURRENCE STATEMENT. THERE IS NO STATEMENT ON THE DEVICE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF REPRESENT A CONCLUSION BY GRASBY MEDICAL LTD THAT THE CONTENTS OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE DEVICE LISTED FAILED IN ANY MANNER AND/OR THE DEVICE CAUSED OR CONTRIBUTED TO THE ALLEGED DEATH OR DETERIORATION IN THE STATE OF HEALTH OF ANY PERSON.
PT HAD CATARACT EXTACTION WITH INSERTION OF INTRAOCULAR LENS RIGHT EYE IN 6/85. PRESENTS WITH PSEUDOPHAKIC BULLOUS KERATOPATHY. INTRAOCULAR LENS REMOVED.
THE BALLOON OF THIS DEVICE BURST WHILE DILATING A CALCIFIED LESION FOR STENTING. THE DEVICE WAS REMOVED WITH NO CONSEQUENCE TO THE PT. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.
PT HAD CATARACT EXTRACTION WITH INTRAOCULAR LENS INSERTION IN 8/96. PT PRESENTS WITH DISLOCATED INTRAOCULAR LENS FOR REMOVAL.
PT HAD CATARACT EXTRACTION WITH INTRAOCULAR LENS INSERTION DATE UNKNOWN. PRESENTS WITH PSEUDOPHAKIC BULLOUS KERATOPATHY WITH PAIN.
PUMP MALFUNCTION WITH CONTINUOUS BEEPING, ERROR DTECTED ON SCREEN. PUMP WILL NOT FUNCTION. PCA PT. REPLACED PUMP IN THE MIDDLE OF NIGHT FOR PT ON PAIN PUMP. PT MISSED APPROX 90 MINS OF THERAPY.
THE DR CLAIMS THAT THE GRAFT "OOZED" BLOOD (QUANTITY UNK) THROUGH ITS WALLS, THE BLEEDING WAS STOPPED WITH GELFOAM AND TOPICAL THROMBIN. THE GRAFT WAS LEFT IN. THE PT IS FINE.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVALUAITON, THE COMPLAINT CANNOT BE CONFIRMED, OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE QUALITY ASSURANCE TEST RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE TEST RECORDS WERE NOT ATYPICAL -NO SIMILAR COMPLAINTS AGAINST THIS BATCH.
TUBING NOT USED ON PT SINCE DEFECT IN TUBING WAS SO OBVIOUS UPON OPENING PACKAGE. END OF TUBING BELOW CONNECTION IS PINCHED AND TORN.
THE PT, A TYPE II DIABETIC, REPORTED LOWER BLOOD GLUCOSE READINGS WITH 2 BOXES OF TEST STRIPS ONE BOX LOT 1J515B AND ONE BOX LOT UNK. APPROX TWO MONTHS AGO, THE PT PURCHASED A BOX OF TEST STRIP LOT UNK, AND OBTAINED LOWER BLOOD GLUCOSE READINGS (APPROX 50 POINTS LOWER THAN HER USUAL READINGS WITH ANOTHER TEST STRIP. SHE COULD NOT REMEMBER SPECIFIC RESULTS. BECAUSE OF THE LOWER BLOOD GLUCOSE READINGS, SHE DISCARDED ONE BOTTLE FROM THIS BOX APPROX 3 WEEKS AGO. SHE EXCHANGED THE SECOND BOTTLE FROM THE SAME BOX OF TEST STRIPS AT THE PHARMACY FOR A NEW BOX OF TEST STRIPS LOT 1J515B. THE PHARMACIST DISCARDED THE SECOND BOTTLE OF TEST STRIPS FROM THE FIRST BOX. THE PT IMMEDIATELY OPENED THE FIRST BOTTLE FROM LOT 1J515B AND OBTAINED A BLOOD GLUCOSE RESULT OF 60 MG/DL. BECAUSE SHE FELT THIS WAS EXTREMELY LOW, SHE IMMEDIATELY OPENED THE SECOND BOTTLE FROM THE SAME BOX, LOT 1J515B, AND OBTAINED A BLOOD GLUCOSE READING OR 88 MG/DL. THE DESICCANT IS IN ALL BOTTLES. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE PT DID NOT HAVE NORMAL CONTROL SOLUTION. WITH THE REP, THE PT OBTAINED A CHECK STRIP TEST RESULT OF 84 VERSUS A CHECK STRIP RANGE OF 72-96. THE PT STORES HER TEST STRIPS IN HER BEDROOM.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 11/1/96. TWO OPENED BOTTLES, ONE CONTAINING 23 STRIPS AND ONE CONTAINING 12 STRIPS, WITH DESICCANT WERE RETURNED TO CO FOR EVAL. THE TEST RESULTS OF THE RETURNED BOTTLE CONTAINING 23 STRIPS MET THE SPEC FOR BLOOD GLUCOSE ACCURACY. THE TEST RESULTS OF THE RETURNED BOTTLE CONTAINING 12 STRIPS WERE BELOW THE SPEC FOR BLOOD GLUCOSE ACCURACY. EVAL OF THE DESICCANT INSIDE THE RETURNED BOTTLES INDICATES THAT FAILURE MAY BE DUE TO EXPOSURE TO MOISTURE. THE SOURCE OF MOISTURE EXPOSURE IS UNK. THE RETENTION SAMPLE TEST RESULTS FOR LOT 1J515B MEET THE SPECS FOR THE BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE EVAL OF RETENTION SAMPLES, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? YES. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? YES. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
PT HAD PREVIOUS CATARACT EXTRACTION IN 1981 OR 1982. PRESENTS WITH SUBLUXATED INTRAOCULAR LENS. THE LENS WAS REMOVED AND REPLACED.
BLADES WERE TOO DULL, THEY BARELY CUT TISSUE.
PT WAS UNDERGOING A CEREBRAL ANGIOGRAM WHEN PART OF THE GUIDEWIRE BROKE OFF AND LODGED IN PT'S BRAIN. AN ATTEMPT WAS MADE TO RETRIEVE GUIDEWIRE BUT WAS UNSUCCESSFUL. PT PLACED ON ANTICOAGULANTS.
PT HAD PREVIOUS CATRACT EXTRACTION WITH INSERTION OF INTRAOCULAR LENS, DATE OF SURGERY UNKNOWN. PRESENTS WITH PSEUDOPHAKIC BULLOUS KERATOPATHY. INTRAOCULAR LENS REMOVED AND REPLACED.
BALLOON PUMP ALARMED KINKED CATHETER. CONSOLE PURGED AND TURNED BACK ON. BALLOON AUGMENTATION NOTED, CONSOLE ALARMED AGAIN. VISUAL INSPECTION OF EXTRACORPOREAL TUBING OF BALLOON CATHETER REVEALED POWDERED BLOOD PARTICLES. PUMPING HALTED AND BALLOON WAS DISCONTINUED WITHOUT DIFFICULTY. VISUAL INSPECTION OF THE REMOVED CATHETER REVEALED POWDERED CLOTS INSIDE THE BALLOON. THE PT RECEIVED ANOTHER BALLOON CATHETER SHORTLY AFTERWARD.
PT HAD PREVIOUS CATARACT EXTRACTION AND SECONDARY INTRAOCULAR LENS IMPLANT. THE DATE OF THIS PROCEDURE IS UNKNOWN. THE PT PRESENTS WITH PSEUUDOPHAKIC BULLOUS KERATOPATHY. THE INTRAOCULAR LENS WAS REMOVED AND REPLACED.
THE PT DIED AFTER THE HEMOSTASIS VALVE WAS REMOVED FROM THE SHEATH BY THE NURSE, ALTHOUGH THE SHEATH WITH A CATHETER THROUGH IT REMAINED IN THE PT. WHEN THE CATHETER WAS REMOVED FROM THE SHEATH, THE PT SUFFERED AN AIR EMBOLISM AND DIED. THE REPORTER FROM THE HOSPITAL STATED THAT THERE WAS NO PRODUCT DEFECT OR MALFUNCTION, AND THAT THE INCIDENT WAS DUE TO USER ERROR.
CLOTTED GRAFT IN PT WITH END STAGE RENAL DISEASE.
TO ENSURE SAFETY, CHILDPROOF CAPS ARE SUPPOSED TO BE PUSHED DOWN AND TURNED IN ORDER TO BE OPENED. BUT IN THIS SITUATION, THE CAPS WERE OPENED JUST BY TURNING THEM.
PT WITH AORTIC STENOSIS REFERRED FOR BALLOON VALVULOPLASTY. FIVE INFLATIONS PERFORMED WITH 20MM BALLOON WITHOUT PROBLEM. BALLOON EXCHANGED FOR 23MM AND 13 MORE INFLATIONS WERE PERFORMED. BLOOD WAS NOTED IN INFLATION SYRINGE DURING INFLATIONS. WHEN ATTEMPTING TO REMOVE BALLOON, BALLOON SEPARATED FROM SHAFT OF DEVICE. RETRIEVAL DEVICES WERE USED TO PULL BALLOON INTO DESCENDING AORTA AND ILLIAC ARTERY. PT WENT TO SURGERY FOR REMOVAL OF PRODUCT.
PVC IMPLANTED PULSE GENERATOR WAS EXPLANTED DUE TO EXPIRATION OF BATTERY.
PT EXPERIENCED SEVERAL NEAR-SYNCOPAL EPISODE WITH SOME CHANGE IN LEAD IMPEDANCE. PT WAS HOLTER MONITORED, SHOWING OVER-SENSE AND FURTHER IMPEDANCE CHANGES. EPICARDIAL LEAD WAS NO LONGER FUNCTIONING AS IT HAD PREVIOUSLY. LEAD WAS ORIGINALLY PLACED IN 1984. PHYSICIAN CAPPED LEAD, EXPLANTED PACER. REPLACED IT WITH ANOTHER IN AN INFRACLAVICULAR SITE.
PUMP BECAME STUCK IN DOWN LINE OCCLUSION MODE AND COULD NOT BE CLEARED, EVEN AFTER PUMP WAS RETURNED TO PHARMACY.
THE CUSTOMER REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH TEST STRIPS. ON 10/17/96, THE CUSTOMER OPENED THE FIRST BOTTLE FROM A BOX OF FIFTY AND OBTAINED A READING OF 88 MG/DL. SHE DID NOT THINK THE RESULT WAS ACCURATE BECAUSE SHE DID NOT FEEL THAT LOW. SHE PERFORMED A SECOND BLOOD TEST WITH A RESULT OF 30 MG/DL. THE CUSTOMER IMMEDIATELY PERFORMED TWO BLOOD GLUCOSE TESTS USING ANOTHER BRAND STRIPS, LOT # 609868A, CODE 6, EXPIRATION 9/98. THE RESULTS WERE 149 AND 102 MG/DL. SHE IMMEDIATELY CALLED THE CO'S CUSTOMER SUPPORT LINE AND, WITH THE REP, PERFORMED A NORMAL CONTROL SOLUTION TEST ON BOTH BRANDS OF TEST STRIPS. THE RESULT TEST STRIP WAS 142 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 103-155 MG/DL. THE RESULT WITH ANOTHER TEST STRIPS WAS 99 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 77-109 MG/DL. THE SOLUTION, LOT # VA315, EXPIRATION 2/97, WAS OPENED TODAY AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. ALSO WITH THE REP A CHECK STRIP TEST WAS PERFORMED. THE RESULT WAS 89 VERSUS A RANGE OF 72-96. THE DESICCANT IS IN THE OPENED BOTTLE. THE CUSTOMER STORES HER STRIPS IN THE BEDROOM.
THE CUSTOMER RETURNED TEST STRIPS WERE ELVALUATED ON 10/30/96. TWO BOTTLES WITH DESICCANT, ONE OPENED CONTAINING 17 STRIPS AND ONE UNOPENED CONTAINING 25 STRIPS, WERE RETURNED TO CO FOR EVAL. THE TEST RESULTS OF BOTH RETURNED BOTTLES WERE BELOW THE SPEC FOR BLOOD GLUCOSE ACCURACY. ERROR GRID ANALYSIS INDICATES THAT THE TEST STRIPS FROM THE OPENED BOTTLE PRODUCE RESULTS WHICH FALL IN ZONE D, AND REPRESENT A REASONABLE RISK OF SERIOUS INJURY. ERROR GRID ANALYSIS INDICATES THAT THE TEST STRIPS FROM THE UNOPENED BOTTLE PRODUCE RESULTS WHICH FALL IN ZONE B, AND DO NOT REPRESENT A REASONABLE RISK OF SERIOUS INJURY. EVAL OF THE DESICCANT INSIDE THE RETURNED OPENED BOTTLE INDICATES THAT FAILURE MAY BE DUE TO EXPOSURE TO MOISTURE. THE SOURCE OF MOISTURE EXPOSURE IS UNK. IS EVENT OCCURING MORE FREQUENTLY THAN STATED IN LABELING? YES. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE ? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? YES. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
PURSUANT TO INFO RECEIVED FROM HOSPITAL, DR OPENED A SALINE DEVICE AND OBSERVED A HAIR WITHIN THE PACKAGING OF THE DEVICE. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE.
SUBMISSION OF THIS REPORT BY MENTOR H/S IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY. MENTOR H/S EXPRESSLY DENIES THAT ANY INFO CONTAINED IN THIS REPORT CONSTITUES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION. MENTOR H/S HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. CO DEFERS TO THE PT'S PHYSICIAN AND TO ANY CHARACTERISTICS REFERENCED IN THE PRODUCT EVAL ATTACHED HERETO." ADD'L INFO IS TO BE SUBMITTED. THE EVENT FREQUENCY IS NOT ADDRESSED IN PRODUCT LABELING. IT IS UNKNOWN IF EVENT IS OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT. THE EVENT SEVERITY IS NOT ADDRESSED IN PRODUCT LABELING. IT IS UNKNOWN IF EVENT SEVERITY IS GREATER THAN USUAL FOR PRODUCT.
THE BALLOON AND DISTAL BALLOON PORTION OF THE BALLOON CATHETER DETACHED AND REMAINED IN THE PT DURING AN AORTIC VALVULOPLASTY OF A CALCIFIED LESION IN VERY TORTUOUS ANATOMY THAT HAD BEEN DIFFICULT TO ACCESS. THE BALLOON HAD BEEN INFLATED A TOTAL OF THIRTEEN TIMES. ATTEMPTS TO SNARE THE CATHETER SEGMENT WERE UNSUCCESSFUL. THE SEGMENT WAS SURGICALLY RETRIEVED WITHOUT INCIDENT. THE PT'S CONDITION IS FINE. THIS DEVICE WAS NOT AVAILABLE FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. CO'S FOLLOW UP REVEALED THAT A HOLE IN THE SHAFT WAS NOTED DURING THE PROCEDURE, HOWEVER ANOTHER DILATATION WAS PERFORMED AS THE PT'S ANATOMY WAS VERY TORTUOUS AND DIFFICULT TO ACCESS. IT WAS ALSO INDICATED THE LESION WAS CALCIFIED. FURTHER, THIS BALLOON CATHETER IS RECOMMENDED FOR USE AS A PULMONIC VALVULOPLASTY DILATATION CATHETER. SINCE THIS CATHETER WAS USED IN A NON-INDICATED PROCEDURE AND THE ABOVE NOTED CONDITION WAS PRESENT, CO BELIEVES THAT USER TECHNIQUE AND/OR PT ANATOMY MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, WITHOUT EVALUATING THE DEVICE CO CANNOT ATTRIBUTE THE EXACT CAUSE FOR THIS EVENT.
MOTOR FLAG ERROR FAILED TO INFUSE DESIGNATED AMOUNT OF MEDICATION.
RPTR STATED, THE SCOOTER IS NOT WORKING ANY MORE. THE SCOOTER WAS BOUGHT ON 3/20/96.
48" TRANSFER SET TO CATHETER CHANGED AND LEAK WAS NOTED AT SAFE LOCK CONNECTION WHERE CONNECTOR JOINS TUBING. CLAMPED OFF AND NEW TUBING CHANGE DONE. PT PLACED ON ANTIBIOTICS.
ACCORDING TO HOSP'S RISK MGMT DIR: "PT WAS A 77-YR-OLD, MALE CORONARY ARTERY BY-PASS PT, WITH COPIOUS SECRETIONS. HE WAS A HEAVY SMOKER, WITH COPD HISTORY, INCLUDING ASTHMA AND ALLERGIES (I.G. PERFUME). PT WAS VENTILATOR DEPENDENT, WITH "TRACH" IN PLACE SINCE 10/4/96. ON 10/8/96, STAFF HAD DIFFICULTY SUCTIONING PT, THOUGHT "TRACH" BLOCKED, REMOVED "TRACH", COULDN'T REINTUBATE. REINTUBATED ORALLY. TRIED TO BAG PT, GAVE BAG 2-3 SQUEEZES. PT DID NOT EXHALE. REMOVED RESUSCITATOR. PT EXHALED. REPEATED THIS CYCLE 4 TIMES. PT WENT IN CARDIAC ARREST, GAVE CPR FOR SOMETIME. NO RESULTS. AFTER A WHILE, IT BECAME EASY TO BAG PT, CONSIDERED HIM REVIVED. LATER DETERMINED PT NEUROLOGICALLY DEAD. PULLED LIFE SUPPORT 10/10/96. A RESPIRATORY THERAPIST/REGISTERED NURSE WHO WAS NOT PRESENT DURING INCIDENT, "SPECULATED" FROM INFO PROVIDED BY UNDETERMINED STAFF MEMBER, THAT THE RESUSCITATOR EXHALATION (DUCKBILL) VALVE WAS STUCK. THE RESUSCITATOR BAG FUNCITONED NORMALLY PRIOR TO CODE AND LATER IN CODE IT FUNCTIONED OKAY. DIR RISK MGMT IS TRYING TO DETERMINE, IF THE SAME RESUSCITATOR WAS USED ON 10/7 AND 10/8/96. THE HOSP'S PROTOCOL IS TO CHANGE THE RESUSCITATOR EVERY TWO DAYS. NOT SURE IF RESUSCITATOR WAS USED LONGER. THE PT DID NOT HAVE PNEUMOTHORAX AS DETERMINED BY X-RAY DURING CODE.
NO PRODUCT RETURNED FOR EVAL. FROM CONVERSATIONS WITH THE HOSP, CO DOES NOT HAVE ANY SOUND EVIDENCE THAT THE CO'S RESUSCITATOR MALFUNCTIONED. THEREFORE, CO IS NOT TAKING ANY FURTHER ACTION AT THIS TIME. IF THE RESUSCITATOR IS RETURNED TO CO CO WILL CONDUCT A COMPLETE EVAL. NO OTHER COMPLAINTS OF THIS TYPE IS CO'S FILES.
MFR CONFIRMED A HOLE IN THE TUBING CONNECTOR DUE TO EXCESS SOLVENT.
THE CUSTOMER REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH TEST STRIPS LOT # UNK. SHE OPENED THE TEST STRIPS APPROX 2 OR 3 WEEKS AGO AND OBTAINED A READING OF 23 MG/DL. SHE DID NOT BELIEVE THIS READING TO BE ACCURATE BECAUSE HER BLOOD GLUCOSE LEVEL IS "NEVER" THAT LOW. SHE ALSO STATED THAT SHE HAD EXCESSIVE THIRST AND FATIGUE, SYMPTOMS OF HIGH BLOOD GLUCOSE. THE DESICCANT IS IN THE BOTTLE OF STRIP. HER HOME NURSE SET THE CODE CORRECTLY IN HER METER. THE CUSTOMER IS PARTIALLY VISUALLY IMPAIRED AND IS NOT COMFORTABLE PERFORMING A CHECK STRIP TEST OR A NORMAL CONTROL SOLUTION TEST. SHE WAS ALSO UNABLE TO READ THE LOT NUMBER ON THE BOTTLE.
THE CUSTOMER IS PARTIALLY VISUALLY IMPAIRED AND SHE WAS UNABLE TO READ THE LOT NUMBER ON THE BOTTLE. THEREFORE, BEFORE RECEIPT OF THE RETURNED PRODUCT, THE LOT NUMBER IS UNK. CO REQUESTED THAT THE PRODUCT BE RETURNED FOR EVAL ON 10/18/96. AS OF 11/15/96, RETURNED PRODUCT HAS NOT BEEN REC'D. CO WILL FORWARD A FOLLOW-UP TO THIS REPORT UPON RECEIPT OF RETURNED TEST STRIPS AND THEIR EVAL. TIME FRAME IS UNK. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NO. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
THE DERMATOME ALLEGEDLY TOOK A FULL THICKNESS SKINGRAFT, EVEN THOUGH IT WAS NOT SET TO TAKE A FULL THICKNESS.
DURING ROUTINE CXR IT WAS NOTED THAT CATHETER TIP HAD SEPARATED FROM CATHETER. CATHETER TIP REMOVED BY RADIOLOGY WITH NO COMPLICATIONS.
DURING ROUTINE CXR WAS NOTED THAT CATHETER TIP HAS SEPARATED FROM CATHETER. CATHETER TIP REMOVED BY RADIOLOGY WITH NO COMPLICATIONS.
DURING A PROCEDURE, THE PENDANT HEAD OF CEILING SERVICE UNIT SEPARATED FROM THE BEARING JOINT. TECHNICIAN AND HOSPITAL STAFF SECURED THE UNIT BY RESTING IT ON A CART SO THAT THERE WAS NO TENSION ON ANY OF THE LINES. THE PROCEDURE WAS COMPLETED WITH NO FURTHER DELAYS, COMPLICATIONS OR INTERRUPTION OF SERVICES. UPON INSPECTION, IT WAS FOUND THAT THE (4) M6X55MM BOLTS AND LOCK WASHERS WERE IN PLACE, BUT HAD BEEN UNSCREWED FROM PENDANT HEAD ROTATION BEARINGS. THE THREADED HOLES SHOW NO SIGN OF WEAR OR DAMAGE. THE LAST THREAD OF (1) BOLT WAS PULLED OFF IN THE SEPARATION. TOTAL SEPARATION WAS 4" AND OCCURRED AT LOCATION B. ALL NECESSARY REPAIRS WERE COMPLETED, AND INSPECTIONS WERE MADE OF ALL OTHER UNITS IN THE HOSPITAL. UPON INSPECTION, IT WAS FOUND THAT UNITS HAD HAD ADDITIONAL PORTS INSTALLED WITHOUT CO'S SUPERVISION OR SUPPORT.
A NURSE REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH TEST STRIPS. ON 10/16/96, THE NURSE OPENED THE FIRST BOTTLE FROM A BOX OF FIFTY AND OBTAINED CONTROL SOLUTION RESULTS OF 97,94 MG/DL. THE NURSE CALLED THE CO CUSTOMER SUPPORT LINE AND, WITH THE REP PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 88 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 103-155 MG/DL. THE SOLUTION, LOT # VJ209, EXPIRATION 3/97, WAS OPENED ONE MONTH AGO AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. ALSO WITH THE REP, THE NURSE PERFORMED A CHECK STRIP TEST. THE RESULT WAS 77 VERSUS A RANGE OF 68-92. THE DESICCANT IS IN THE OPEN BOTTLE. THE CONTACT STATED THAT THE TEST STRIPS ARE STORED IN A LOCKED CABINET.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 11/1/96. TWO OPENED BOTTLES WITH DESICCANT, ONE CONTAINING 14 STRIPS AND ONE CONTAINING 17 STRIPS, WERE RETURNED TO CO FOR EVAL. THE NORMAL CONTROL READINGS FOR BOTH RETURNED BOTTLES WERE BELOW THE SPECIFIED CONTROL RANGE. EVAL OF THE DESICCANT INSIDE THE RETURNED BOTTLES INDICATES THAT FAILURE MAY BE DUE TO EXPOSURE TO MOISTURE. THE SOURCE OF MOISTURE EXPOSURE IS UNK. THE RETENTION SAMPLE TEST RESULTS FOR LOT 1K520B MEET THE SPECS FOR THE BLOOD GLUCOSE ACCURACY AND PRECISION, AND THE NORMAL CONTROL READINGS ARE ALSO WITHIN THE SPECIFIED RANGE. BASED ON THE EVAL RETENTION SAMPLES, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
PT WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB AND AN 8 FRENCH SHEATH WAS PLACED IN HER RIGHT FEMORAL ARTERY. DURING INTUBATION OF HER RIGHT CORONARY ARTERY WITH THE GUIDING CATHETER, THE BODY OF GUIDING CATHETER BECAME TWISTED AND BROKE OFF. A PERCUTANEOUS ATTEMPT TO RECOVER THE CATHETER WAS UNSUCCESSFUL. SHE WAS TAKEN TO THE O.R. FOR SURGICAL EXTRACTION OF THE GUIDING CATHETER.
DURING ROUTINE CXR OR CT IT WAS NOTED THAT CATHETER TIP HAD SEPARATED FROM THE CATHETER. CATHETER TIP REMOVED BY RADIOLOGY WITH NO COMPLICATIONS.
PT HAD A 4CM INCISION TO (L) ANKLE & 7CM INCISION TO (L) UPPER LEG WITH STRIPS IN PLACE FOLLOWING AN AORTIC BYPASS ON 10/10/96. PT HAD REHEATED (BY BOILING) A PREVIOUSLY USED COMPRESS AND PLACED A CLOTH BETWEEN THE COMPRESS TO APPLY TO THE INCISION TO UPPER (L) LEG. HOWEVER, PT HAD FALLEN ASLEEP WITH LEGS TOGETHER AND THE COMPRESS PRESSED AGAINST THE (R) MID-THIGH WITHOUT A PROTECTIVE CLOTH TO THAT PORTION OF THE COMPRESS AND CONSEQUENTLY SUSTAINING A BURN. PHYSICIAN WAS CONTACTED; NO ORDERS RECEIVED FOR TREATMENT; LEAVE OPEN TO AIR. COMPRESS CONTAINED SODIUM ACETATE (FOOD GRADE) AND WATER. (NON-TOXIC). (
AS CAN BE SEEN FROM THE CALL LOG ABOVE, MEDI-JECT HAS ATTEMPTED TO WORK WITH THIS CUSTOMER TO ACHIEVE OPTIMAL PERFORMANCE OF THE PRODUCT. MEDI-JECT WILL UPGRADE THE UNIT WITH THE NEW NOZZLE DESIGN IF IT IS RETURNED. FURTHERMORE, IT IS IMPOSSIBLE TO DETERMINE IF THERE ARE ANY OTHER MECHANICAL PROBLEMS WITHOUT HAVING THE DEVICE TO TEST. FROM THE INFO PROVIDED TO MEDI-JECT, CO IS UNAWARE OF ANY MDR REPORTABLE EVENTS (I.E., SERIOUS INJURY OR DEATH RESULTING FROM USE OF THE DEVICE). THEREFORE, NO MDRS WERE FILED WITH FDA.
THE DR CLAIMS THAT THE GRAFT "OOZED" BLOOD (QUANTITY UNKNOWN) THROUGH ITS WALLS. THE BLEEDING WAS STOPPED WITH GELFOAM AND TOPICAL THROMBIN. THE GRAFT WAS LEFT IN. THE PT IS FINE.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION: "F" COMPLETED BY MFR.
ACCESS CATHETER HAD TEARS IN IT. CATHETER REMOVED 11/7/96.
PT HAD A DUAL CHAMBER PACEMAKER INSERTED 9/20/96 FOR SICK SINUS SYNDROME. ANOTHER PT WAS ADMITTED TO HOSP 10/9/96 WITH PERICARDIAL EFFUSION AND TRANSFERRED TO THIS HOSP DIAGNOSED WITH ACUTE TAMPONADE DUE TO LEAD PERFORATION OF RIGHT VENTRICLE. PERICARDIAL WINDOW DONE 10/9/96. EXPLANTATION WITH REPLACEMENT DONE 10/10/96 WHICH SHOWED AN UNEXPECTED FRACTURE OF THE TRIAL LEAD INSULATION.
USER TRANSFERRED 100 ML D5W FROM A PLASTIC BAG INTO A GLASS EMPTY EVACUATED CONTAINER. TO THIS SOLUTION USER ADDED 150 MG CORDARONE IV. AN IMMEDIATE CLOUDY HAZE DEVELOPED, NEVER DISAPPEARING. THE CORDARONE WAS ADDED TO A BOTTLE WITH A VACUUM AND WENT IN QUITE RAPIDY.
THREE SEPARATE IV TUBING BLEW APART DURING RESUSCITATION OF CODE BLUE PT WHILE PUSHING IVP EMERGENCY DRUGS.
PRESENTED FOR BREAST IMPLANT EXCHANGE. HAS HAD IMPLANTS SINCE 1976. DESIRES TO INCREASE SIZE OF IMPLANTS. COMPLAINS OF PAIN AND DISCOMFORT ON EXAM OF BREAST. THERE IS SOME IRREGULARITY IN THE SHELL OF THE IMPLANTS ON EXAM. BILATERAL BREAST IMPLANTS EXPLANTED ON 10/21/96, BOTH RIGHT AND LEFT IMPLANTS FOUND RUPTURED.
LEFT FRONT LEG OF WALKER PULLED OUT OF SOCKET BY RESIDENT. WALKER LEG LOWERED TO FLOOR PLACING RESIDENT OFF BALANCE RESULTING IN THE FALL. RESIDENT SUSTAINED A 3CM LACERATION ABOVE LEFT EYEBROW. WAS TRANSFERRED TO HOSP EMERGENCY ROOM AND RECEIVED 6 SUTURES TO THE LACERATION. WAS THEN RETURNED TO THIS FACILITY.
IMPLANTED PULSE GENERATOR WAS EXPLANTED DUE TO EXPIRATION OF BATTERY.
AT 12:15AM ROUNDS CNAS NOTED THAT RESIDENT WAS RESTING. AT 1:30AM CNAS FOUND RESIDENT WITH (L) ARM & HEAD BETWEEN MATTRESS & SIDERAIL. RESIDENT'S THROAT WAS PRESSING ON TOP END SECTION OF SIDE RAIL & THERE WAS NO SIGN OF LIFE. PHYSICIAN NOTIFIED DON & ADMINISTRATOR & FAMILY NOTIFIED.
DURING AN AORTO-MESENTERY ESCHEMIA PROCEDURE, WHILE IMPLANTING, THE DR NOTICED THAT THE GRAFT WAS LEAKING BLOOD THROUGH HOLES IN BOTH DISTAL ENDS OF THE GRAFT. THE ESTIMATED BLOOD LOSS WAS APPROX 200 CC. THE HOLES WERE REPAIRED, THE GRAFT WAS LEFT IN. THE PT'S CONDITION IS OK. NO PRODUCT IS TO BE RETURNED FOR EVALUATION.
NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR.
PT WAS POST OPERATIVE FROM KNEE SURGERY AND WAS BEING PREPARED FOR TRANSFER TO REHAB. IV CATHETER WAS REMOVED AND FOUND THAT APPROX 1/2" HAD BROKEN OFF THE DISTAL END.
AS PHYSICIAN WAS DRILLING OUT THE FIRST SCREW THE END OF DRILL BIT BROKE OFF IN THE PT. THE PIECE IS APPROX 3MM. PIECE WAS LEFT IN PT. (PT DIAGNOSIS-FRACTURED LEFT HIP).
WHILE TRANSPORTING A NURSING HOME RESIDENT INTO A SHOWER ON A PVC SHOWER CHAIR, THE LEGS OF THE SHOWER CHAIR BROKE, ABOVE THE WHEELS, CAUSING THE RESIDENT TO FALL TO THE FLOOR. IN AN ATTEMPT TO KEEP THE RESIDENT FROM HARM, ONE OF FACILITIES EMPLOYEED SUSTAINED INJURIES TO HER SHOULDER AND ARM.
UNATTENDED DEATH, RESIDENT WAS FOUND AT 8:45AM ON 11/05/96 IN HIS BED BETWEEN THE BED AND THE SIDERAIL HELD BY A VEST RESTRAINT THAT WAS STILL TIED TO BOTH SIDES OF THE BED. THE INVESTIGATION DETERMINED THAT THE RESIDENT APPEARED TO BE TRYING TO GET UP OUT OF THE BED, FELL BETWEEN THE RIGHT SIDE OF THE BED AND THE SIDE RAIL IN THE MID-SECTION OF THE BED. THE SIDE RAILS ARE SPLIT HALF RAIL, TWO PER SIDE. RECENT ADMISSION 10/29/96 FROM THE HOSP WITH DIAGNOSIS OF :LAKA-LEFT ABOVE THE KNEE AMPUTATION, ISCHEMIA, RHABDOMYOLYSIS, AGITATED DEMENTIA.
PT WAS DIAGNOSED WITH A FRONTAL TRAUMATIC DEFECT, 6CM LONG AND 3 CM WIDE. THE SURGEON HAD TO WAIT OVER 60 MINUTES FOR THE DEVICE TO GET HARD. THIS WAS AN EXTENDED AMOUNT OF SURGERY TIME.
PT WAS DIAGNOSED WITH A POST TRAUMATIC SKULL DEFECT. UPON PLACING THE DEVICE THE SURGEON HAD TO WAIT FOR OVER 60 MINUTES FOR THE PRODUCT TO HARDEN.
PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE PATELLA WAS REPLACED. THIS PATELLA WAS A WHITE POROUS IMPLANT.
12V, 100W LAMP LOCATED WITHIN THE COLLIMATOR BURST. THERE WERE NO INJURIES ON EITHER PT OR OPERATOR.
IS FREQUENCY OF OCCURRENCE OF THIS EVENT ADDRESSED IN DEVICE LABELING? N. IS SEVERITY OF OCCURRENCE OF EVENT ADDRESSED IN DEVICE LABELING? N. IS SEVERITY GREATER FOR THIS EVENT THAN USUAL? U.
OPENED 10 PACK OF STERILE 4 X 4'S DURING SURGICAL PROCEDURE. UPON INSPECTION DISCOVERED WHAT APPEARS TO BE AN INSECT IN THE GAUZE PRODUCT. PULLED OUT OF O.R. ROOM FOR RETURN TO VENDOR FOR INSPECTION.
CO RECEIVED INFO THAT THIS LEAD WAS REMOVED FROM SERVICE DUE TO A LEAD FRACTURE. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO REPLACE ALL THE LEADS WITH ANOTHER TRANSVENOUS DEFIBRILLATION LEAD.
THE CUSTOMER REPORTED THAT INSUFFICIENT VOLUME WAS DISPENSED INTO WELL POSITION A9 WHILE RUNNING A HEPATITIS CORE ASSAY USING SAMPLE HANDLER, SERIAL NUMBER 2330. NO ERROR MESSAGE WAS GENERATED. CO'S FIELD SVC ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.
CATHETER KINKED WHILE INSERTED, RESTRICTED FLOW AND REQUIRED REPLACEMENT.
AFTER THE FABRIC WAS IMPLANTED AS A CAROTID PATCH, IT LEAKED BLOOD (QUANTITY UNKNOWN). THE PATCH WAS TREATED WITH TOPICAL THROMBIN AND BECAME BLOOD-TIGHT. THE PATCH WAS LEFT IN. THE PT'S CONDITION IS STABLE.
THESE PRODUCTS ARE PACKAGE 5 UNITS TO A BOX. EXAM AND TESTING OF THE RETURNED FOUR UNUSED INTACT PRODUCTS FROM THIS SAME BOX REVEALED THAT ONE OF THE 4 TESTED HIGHER THAN THE LABELED SPECIFICATION FOR POROSITY, THE REMAINING 3 TESTED WITHIN LABELED SPECS. SINCE THE COMPLAINT PRODUCT, ITSELF, WAS LEFT IN THE PT AND THEREFORE NOT AVAILABLE FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED, OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. THE BATCH RECORDS WERE NOT ATYPICAL-NO SIMILAR COMPLAINTS AGAINST THIS BATCH. BASED UPON THE ABOVE, THE MFR BELIEVES THIS EVENT WAS PROBABLY CAUSED BY AN ANOMALY WITHIN THIS INDIVIDUAL PACKAGE AND IS NOT A BATCH-RELATED PROBLEM.
THE FOLLOWING IS AN EQUIPMENT FAILURE EVALUATION REGARDING EVENTS THAT TRANSPIRED THE EVENING OF 11/7/96 WITHIN THE INTENSIVE CARE UNIT. THIS EVALUATION AS PER REQUIREMENTS FOR THE SAFE MEDICAL DEVICES REPORTING ACT OF 1992. THERE WAS A FAILURE WITH THE PT-CIRCUIT HEATING SYSTEM OF A VENTILATOR RESULTING IN REMOVAL FROM SERVICE OF THE UNIT. IT WAS FURTHER REPORTED THAT THE BREATHING CIRCUIT HEATER ACTUALLY BURNED UP, MELTING A HOLE IN THE CIRCUIT HOSE AND CREATING MUCH SMOKE. FORTUNATELY, THE NURSING STAFF ON DUTY OBSERVED THE PROBLEM AND REMOVED THE UNIT FROM THE PT AND DISCONNECTED ALL POWER. AS PER THE DESCRIBED EVENTS, THE BREATHING CIRCUIT TUBING DID IN FACT SHOW SIGNS OF MELTING IN ONE AREA, IN ADDITION THE HEATING WIRES APPEARED TO HAVE SEVERAL TWISTS IN THEM ABOUT SIX INCHES FROM THE WIRING ENTRY PORT. EVIDENCE SUGGESTS THAT A SHORT CIRCUIT OCCURRED AT THE TWISTED AREA, THE RESULT OF WHICH CAUSED THE WIRING FROM THAT POINT BACK TO THE PLUG-IN CONNECTOR TO RAPIDLY OVERHEAT AND MELT THE INSULATION OFF OF THE WIRES, ALSO TO MELT THE HOLE IN TUBING. THERE WAS NO EVIDENCE TO SUGGEST ANY OBVIOUS PROBLEM WITH THE HEATER CONTROLLER UNIT WHEN VISUALLY INSPECTED. FURTHER TESTING REVEALED THE HEATER CONTROLLER TO BE FUNCTIONING NORMALLY, WITH ALL PARAPMETERS OPERATING WITHIN NORMAL SPECIFICATIONS. IT WAS NOTED, HOWEVER, THAT THE VOLTAGE OPERATING RANGE FOR THE PT BREATHING CIRCUIT WAS 21 VOLTS (AS PER THE TAGS ATTACHED TO THE HEATER WIRE CONNECTORS), WHILE THE OPERATING VOLTAGE FOR THE CONTROLLER AT MAXIMUM OUTPUT WAS ABOUT 30 VOLTS. THIS CLEARLY INDICATES AN INCOMPATIBILITY BETWEEN THE CONTROLLER AND BREATHING CIRCUIT, THE RESULT OF WHICH COULD FULLY ACCOUNT FOR THE EVENTS THAT TRANSPIRED. THIS CASE CLEARLY SUGGESTS THE NEED FOR CLOSE SCRUTINY WHEN INTERMIXING EQUIPMENT MANUFACTURED BY DIFFERENT VENDORS.
DURING PTCA PROCEDURE PT EXPERIENCED AN OPENING IN THE DISTAL RIGHT CORONARY ARTERY RESULTING IN A STAIN OF CONTRAST SHOWING ON THE CONE. EMERGENCY CORONARY BYPASS WAS PERFORMED TO CORRECT OPENING IN CORONARY ARTERY. (TRIPLE CAB). PT DISCHARGED 11/12/96 FROM HOSP IN GOOD CONDITION.
PT HAD A CATHETER PLACED FOR INFUSION (96 HR. CONT. INFUSION) OF CHEMOTHERAPY. CATHETER PLACED 10/02/96. ADMITTED ON 10/04/96 TO BEGIN CHEMOTHERAPY. DRUGS INCLUDED ADRIAMYCIN AND DECARBAZINE. ADRIA IS A KNOWN VESSICANT DRUG. THE CATHETER WAS FUNCTIONING WELL. ON 10/06/96 THE PT BROUGHT TO THE NURSE'S ATTENTION THAT THERE WAS A LEAKAGE AT THE EXIT SITE OF THE LINE. THE LEAKAGE WAS RED, WHICH IS THE COLOR OF ADRIAMYCIN. THE INFUSION WAS IMMEDIATELY DISCONTINUED. THE SITE WAS TREATED AS AN EXTRAVASATION PER PROTOCOL. THE LINE WAS PULLED THE FOLLOWING DAY BY PHYSICIAN. THERE WAS A DEFINITE CRACK IN THE LINE WHICH WAS MIDWAY BETWEEN THE CUFF AND THE SITE WHERE IT ENTERED THE SUBCLAVIAN VEIN. THIS CONINCIDED WITH THE AREA OF REDNESS AND SWELLING ON THE PT'S CHEST WALL.
DURING A STENT PROCEDURE WHILE CHANGING GUIDING CATHETER A DEVICE WAS USED. IN THE PROCESS OF CHANGING OUT THE SHEATH, THE CATHETER APPARENTLY BECAME SEPARATED WITHIN THE PT. THE SITUATION WAS REASSESSED AND IT WAS DECIDED THAT CORONARY ARTRY BYPSS SURGERY WITH RETRIEVAL OF THE LOST SEGMENT WAS NECESSARY. PT HAD BYPASS SURGERY AND IS DOING WELL.
DEFECTIVE CORD CLAMP SLIPPED OFF CORD WHILE STILL CLAMPED. INFANT SUSTAINED BLOOD LOSS.
A 29-YR-OLD FEMALE RECEIVING TREATMENT FOR STEM CELL TRANSPLANT. OBSERVED TO BE SEDATED WITH SLURRED SPEECH. FLUMAZENIL WAS ADMINISTERED TO REVERSE THE EFFECT OF THE LORAZEPAM. THE PT WAS SEEN NEXT DAY IN THE CLINIC, AND WAS REPORTED TO BE DOING WELL WITH NO SEQUELAE NOTED. DETAILS OF PT'S EXPIRATION AND HOW IT RELATES TO DEVICE OPERATION IS UNCLEAR. PT DEATH IS ALLEGEDLY ATTRIBUTED TO OVERINFUSION WHILE USING THE PUMP. TESTING PERFORMED AT MFR. COULD NOT REPRODUCE ANY MALFUNCTION WHICH COULD HAVE CAUSED OVERINFUSION RELATED TO PT INJURY. UNRELATED MALFUNCTION WAS FOUND BUT WOULD NOT HAVE CAUSED INJURY OR DEATH. THE PUMP'S KEYPAD WAS NOTED TO BE LOCKED AND THE AMOUNTS INFUSED ON THE DISPLAY WERE SIDE A: 45.2 CC AND SIDE B: 1.5 CC. THE MASTER CLOCK WAS SET AT 11:18 AM, AND THE CURRENT PST WAS 10:18 AM. A BOLUS WAS REQUESTED, BUT IT DID NOT DELIVER. THIS WAS AGAIN REQUESTED AFTER A FULL LOCKOUT PERIOD HAD EXPIRED, AND AGAIN THE BOLUS DID NOT DELIVER. THE PROGRAMS FOR BOTH SIDES WERE THEN RESET. THE BOLUS THEN DELIVERED CORRECTLY. AN INFUSION TEST WAS BEGUN USING THE CURRENT PROTOCOLS IN THE DEVICE. THE PROGRAM RAN FOR MORE THAN 8 HRS UNTIL THE AMOUNT DELIVERED ON THE DISPLAY TOTALED 991.0 ML. THE VOLUME DELIVERED MEASURED 949.91GM, AN ERROR OF 4.15%. THIS IS WITHIN SPEC FOR THE SYSTEM. DIAGNOSTIC TESTS OF BOTH MOTORS WERE PERFORMED AND WERE ALL WITHIN SPEC FOR THE DEVICE, ALTHOUGH CO DID FIND EVIDENCE OF A FLUID SPILL INSIDE OF THE PUMP ON BOTH MOTOR FRAMES. THOUGH THE PUMP DELIVERED ACCURATELY AND WITHIN SPEC FOR THE SYSTEM, CO DID NOTE THAT THE BOLUS WOULD NOT DELIVER UNTIL THE KEYPAD WAS UNLOCKED AND THE PROGRAMS ON BOTH SIDES RESET.
REPORTER STATED THAT CALLER FROM ACCOUNT REPORTED THAT UNIT OVERFILLED FINAL CONTAINER ON THE BASIS OF REFRACTIVE INDEX BEING OUTSIDE OF THE ACCOUNT'S ACCEPTABLE RANGE. THE DISPLAYS ON THE UNIT FOR PROGRAMMED AND DELIVERED VOLUMES WERE IDENTICAL AND THERE WERE NO ALARMS. NO PT INVOLVEMENT. THE UNIT WAS SWAPPED OUT.
SECTION F COMPLETED BY CO BASED ON INFO RECEIVED FROM THE REPORTER. THE UNIT WAS EXTREMELY DIRTY AND TESTED AS RECEIVED. IT PASSED ALL PERFORMANCE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED.
THE INFUSION PUMP APPEARED TO BE OPERATING BUT NO FLUID WAS BEING DELIVERED. NO ADD'L SPECIFIC CLINICAL INFO WAS ABLE TO BE RECEIVED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATIONS. NO ABNORMALITIES WERE FOUND WITH THE UPSTREAM AND DOWNSTREAM OCCLUSION SENSOR. THE MOST LIKELY CAUSE OF THE REPORTED OCCURRENCE WAS IMPROPER LOADING OF THE IV TUBING THROUGH THE INFUSION PUMP.
PUMP WAS RECEIVED AT SERVICE FACILITY WITH A NOTE INDICATING THE PUMP WAS "INACCURATE". REPORTEDLY THIS PUMP WAS BEING SET UP FOR USE WHEN THE SECONDARY RATE REPORTEDLY "COULD NOT BE ADJUSTED, RAN WIDE OPEN". NO OTHER INFO PROVIDED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION. NO ABNORMALITIES IN THE OPERATION OF THE PUMP WERE FOUND.
PRODUCT NOT RECEIVED YET, BY THE MDR FILING DATE. INITIAL INVESTIGATION ATTACHED BASED ON INFO RECEIVED FROM THE HOSPITAL. THE PRODUCT FOR MDR#162 WAS NOT RECEIVED FOR THE EVALUATION. THE EVALUATION IS LIMITED TO THE INFO AVAILABLE WHICH INDICATES THE CATHETER BROKE IN THE WHITE AREA. THE ONLY WHITE AREAS ON THE DEVICE ARE THE BOLT SPACER AND BOLT COMPRESSOR. THE FORCE REQUIRED TO BREAK EITHER COMPONENT WOULD MOST LIKELY ALSO BREAK THE OPTICAL FIBER TERMINATING OUTPUT AND ELIMINATING ANY READING ERROR. FIXTURE. THIS PROVIDES ADD'L ASSURANCE THAT ALL DRAINAGE BAGS ARE SHIPPED WITH CLAMPS OPEN. IN ADDITION, TRAINING RECORDS WERE REVIEWED, ALL OPERATORS WERE PROPERLY TRAINED. CO HAS REVIEWED THE INTERNAL SYSTEMS ASSOCIATED WITH THE INVOLVED PRODUCT AND HAVE INITITATED APPROPRIATE CORRECTIVE ACTIONS, IF APPLICABLE. IN ADDITION, CO CONTINUES TO MONITOR FEEDBACK FROM OTHER USERS OF THE PRODUCT ON ANY SIMILAR REPORTABLE COMPLAINTS.
PT NEW POST-OP. MD TRIED TO PLACE ICP. WHEN HE PLACED THE CATH IT BROKE AT INSERTION. THEN NURSE FOUND THE FIBEROPTIC INNER PIECE ON THE BED; IT HAD SLID OUT.
THE SALINE DEVICE THAT DR RECEIVED HAD THE OUTER PACKAGING "PEELING OFF" BEFORE SURGERY. NO ADD'L INFO REGARDING THIS OCCURRENCE THE PHYSICIAN NOTED IS AVAILABLE AT THIS TIME.
IS THE EVENT FREQUENCY ADDRRESSED IN PRODUCT LABELING? N. IF "NO" IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT? U. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? Y. IF "YES", IS EVENT OF GREATER SEVERITY THAN STATED IN LABELING? N. "SUBMISSION OF THIS REPORT BY CO IS PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, BUT NOT NECESSARILY REQUIRED THEREBY, CO EXPRESSLY DENIES THAT ANY INFORMATION CONTAINED IN THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE MALFUNCTIONED. PURSUANT TO PART 360I (B) (3), THIS REPORT SHALL NOT BE ADMISSIBLE INTO EVIDENCE OR OTHERWISE USED IN ANY CIVIL ACTION" THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANT", (MENTOR EFFECTIVE DATE, 2/10/92). ANY PERCEIVED INCREASE IN FREQUENCY EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21 CFR803.
THE DEVICE WAS USED DURING A VASCULAR PROCEDURE. IT WAS REPORTED THE DR COMPLAINED ABOUT THE MCL20 CLIPS NOT FORMING OR CLOSING PROPERLY. THE SURGEON COMPLETED THE PROCEDURE BY USING ANOTHER MCL20. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7;D10: INFO UNAVAILABLE. 10/17/96 1513 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/18/96 NNCL SENT. D5,6; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
A VAGUE REPORT WAS RECEIVED THAT THE INFUSION PUMP WAS OPERATING HOWEVER NO FLUID WAS BEING DELIVERED. NO SPECIFIC CLINICAL INFO WAS RECEIVED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION. THE CAUSE OF THE OCCURRENCE WAS MOST LIKELY RELATED TO IMPROPER LOADING OF THE INFUSION PUMP.
THE DEVICE WAS USED DURING A LAPAROSCOPC HERNIA REPAIR. THE TED12 BALLOON BROKE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D10: INFO UNAVAILABLE: SEE CORRESPONDENCE LOG 10/28/96 1105 MESSAGE AND 800# LEFT FOR MD CALL BACK 10/29/96 NNCL SENT. D5,6;H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
THE 3100A VENTILATOR DRIVER DISPLACEMENT INDICATOR (DDI) WAS BLANK WHEN THE VENTILATOR WAS FIRST TURNED ON, THEN THE LEDS COME ON SLOWLY FROM LEFT TO RIGHT AFTER A FEW MINUTES. THERE WAS NO PT INVOLVEMENT AT ALL.
IS FREQWENCY ADDRESSED IN LABELING? NO. IF "NO" - FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "NO" - SEVERITY GREATER THAN USUAL? UNK. THE DDI PROBE WAS RETURNED TO THE FACTORY FOR ANALYSIS. IT HAS BEEN ASSIGNED COMPLAINT #1592A.
THE SERVICE REP REPORTED THAT THE 3100A VENTILATOR COOLING FAN DID NOT OPERATE WHEN THE DRIVER WAS REPLACED DURING ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO PT INVOLVEMENT AT ALL.
IS FREQUENCY ADDRESSED IN LABELING? NO. IF "NO" - FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "NO" - SEVERITY GREATER THAN USUAL? UNK. THE FAN ASSEMBLY WAS REPLACED BY THE SERVICE REP.
DRILL BIT BROKE IN PT. PORTION REMAINS IN PT.
CO IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFO WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, CO, OR IT'S EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.
THE REPORT INDICATED THAT AT THE END OF CARDIOPULMONARY BYPASS, AIR BUBBLES WERE OBSERVED AT THE ARTERIAL OUTLET PORT AND INTO THE ARTERIAL LINE. THE BLOOD FLOW WAS 3.5 L/MIN AND O2 FLOW WAS 2L/MIN. NO PROBLEMS WERE NOTED DURING PRIMING OF THE CIRCUIT OR DURING THE ONE HOUR AND 40 MIN ON BYPASS. THE REPORT ALSO STATED THAT THE CLINICIAN WAS UNSURE HOW THE AIR WAS INTRODUCED INTO THE CIRCUIT. THE PT EXPIRED FROM SEVERE NEUROLOGICAL PROBLEMS.
THE OXYGENATOR WAS RECEIVED FOR COMPLAINT EVALUATION ON 11/12/96. THE RETURNED DEVICE WAS SET-UP IN A SIMULATED PERFUSION CIRCUIT FOR PERFORMANCE TESTING UNDER THE OBSERVATION OF A TECHNICIAN. PRIOR TO TESTING, THE UNIT WAS RINSED WITH PEROXIDE/WATER SOLUTION. VISUAL EXAMINATION NOTED NO PHYSICAL ANOMALIES ON THE RETURNED OXYGENATOR. TESTING WAS PERFORMED AND THE CO2 TRANSFER, O2 TRANSFER, AND BLOOD PRESSURE DROP WERE RECORDED AND FOUND TO BE WITHIN SPECIFICATIONS. THE RESULTS OF THE TESTING ARE AS FOLLOWS: O2 ATRANSFER (SERIAL NUMBER 1564200) 385 ML/MIN. (MINIMUM SPEC) 360 ML/MIN; CO2 TRANSFER (SERIAL NUMBER 1564200) 342 ML/MIN.(MINIMUM SPEC) 285 ML/MIN; PRESSURE DROP (SERIAL NUMBER 1564200) 98MMHG. (MINIMUM SPEC) 80-150 MMHG. CO'S LABORATORY ALSO PRIMED THE UNIT WHILE OBSERVING FOR MICRO/MACRO AIR EMBOLI. THE DEVICE PRIMED WITHOUT DIFFICULTY AND WAS SUBJECTED TO FLOWS OF 3 AND 7 LPM OF FLUID AND GAS FLOW FOR APPROX ONE HOUR UNDER THE OBSERVATION OF A TECHNICIAN. NO AIR EMBOLI WAS OBSERVED THROUGHOUT THE TEST. IN SUMMARY, CO WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THIS REPORT IS MADE PURSUANT TO FEDERAL LAW UNDER 21 CFR PAR 803. THE INFO OR CONCLUSION STATED HEREIN WAS REPORTED TO MEDTRONIC CARDIPULMONARY DIVISION BY THIRD PARTIES AND DOES NOT CONSTITUTE AN ADMISSION OF AND DOES NOT NECESSARILY REFLECT THE VIEWS OR CONCLUSIONS OF MEDTRONIC CARDIOPULMONARY DIVISION, ITS OFFICERS, EMPLOYEES. OR AGENTS.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP JAMMED IN THE NOSE. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION BASED UPON INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONCLUDED THAT INSTRUMENT WAS CONFORMING WITH REGARD TO STAPLES FEEDING, FIRING AND FORMING. INSTRUMENT WAS RECEIVED WITH EXCESSIVE DRIED BODY FLUIDS IN CARTRIDGE AND WITH ONLY ONE STAPLE REMAINING. INSTRUMENT WAS EXAMINED, WAS FOUND TO BE FUNCTIONAL, AND WAS CYCLED AND FIRED REMAINING STAPLE WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO WHY REPORTED INSTRUMENT "JAMMED" DURING SURGERY. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLEY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY.
X-TUBE, OLD MOTION DESIGNS DEALER CLAIMS X-TUBE BROKE ABOUT 2" BELOW WELD.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIPS WERE NOT FORMING PROPERLY AND WERE NOT SECURE. THERE WAS NO CONSEQUENCE TO THE PT. INSTRUMENT FROM FTR13 KIT, LOT NUMBER JA4995.
RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFORMATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVE TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
ABOUT A YR AGO, COMPLAINANT HAD A DENTAL IMPLANT PLACED IN THE UPPER LEFT ROOF OF HIS MOUTH IN PREPARATION FOR A CROWN. ON OR ABOUT 10/11/96, AN ATTEMPT WAS MADE TO PUT THE CROWN ON THE IMPLANT. IN PREPARATION, THE DENTIST PLACED A TORQUING DEVICE ON THE IMPLANT, AND ATTEMPTED TO TORQUE THE IMPLANT TO 20 NEWTONS. WHILE IN THE PROCESS OF TORQUING, COMPLAINANT HEARD A SNAPPING NOISE, AND IMMEDIATELY FELT PAIN IN HIS UPPER JAW AT THE IMPLANT SITE. AN IMPLANT SURGEON WAS CONSULTED. THE X-RAYS SHOWED THE IMPLANT HAD BEEN BROKEN AWAY FROM THE BONE. COMPLAINANT QUESTIONS THE NEED FOR 20 NEWTONS OF FORCE. THE COMPLAINANT ALSO QUESTIONS THE CALIBRATION FUNCTION OF THE DENTIST'S TORQUING DEVICE. COMPLAINANT BELIEVES THE DEVICE IS A BAD DESIGN BECAUSE THE TORQUE IS NOT LIMITED UNTIL 20 N-CM IS REACHED.
PT REPORTED ONE OF HER LENSES WAS VERY IRRITATING, AND SHE WAS UNABLE TO WEAR THE LENS. THE NEXT DAY, SHE HAD TO SEEK MEDICAL TREATMENT, FROM AN OPHTHALMOLOGIST. ON EXAMINATION, OPTHALMOLOGIST REVEALED THREE SMALL CORNEAL ULCERS IN THE LEFT EYE, MID-PERIPHERALLY. PT HAD EDEMA AND PHOTOPHOBIA WITH A FOUR LINE DROP IN VISUAL ACUITY. PT WAS PRESCRIBED TOBRADEX AND CIPROFLOXACIN. PT'S VISUAL ACUITY RETURNED TO 20/20 WITH CORRECTION. THREE SMALL SCARS REMAIN AT THE SITE. PT HAS NOT RETURNED TO CONTACT LENS WEAR AT THIS TIME.
ALL OF SECTION F-10 INFO PROVIDED BY MFG.
TRIGGER MECHANISM OF BARREL OF BIOPSY NEEDLE CAME LOOSE FROM THE HANDLE DURING USER IN RADIOLOGY. NO INJURY TO PT. JUST DEFECTIVE BIOPSY NEEDLE. WILL RETURN TO MFR 10/28/96.
THE INSTRUMENT WAS USED DURING A COLECTOMY. IT WAS REPORTED THE STAPLER WAS HURRIEDLY REMOVED FROM THE PACKAGE AND FIRED. AFTER REMOVING THE STAPLER IT WAS NOTICED THAT THERE WERE NO STAPLES IN THE TISSUE AND NO CARTRIDGE WAS IN THE GUN WHEN IT WAS FIRED. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFO UNAVAILABLE: SEE CORRESPONDENCE LOG. 10/17/96 1505 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/18/96 NNCL SENT. D5,6;H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THE DEVICE WAS USED DURING A BOWEL PROCEDURE. IT WAS REPORTED BY THE REP, DIFFICULT TO CLOSE THE JAWS/BROKEN. THERE WAS NO CONSEQUENCE TO THE PT.
H6; EVALUATION CODE #400(OTHER):FIRING MECHANISM DAMAGED. RESULTS OF EVALUATION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONSITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
THE 3100A VENTILATOR DRIVER DISPLACEMENT INDICATOR (DDI) COULD NOT BE ADJUSTED INTO SPECS. THERE WAS NO PT INVOLVEMENT AT ALL.
IS FREQUENCY ADDRESSED IN LABELING? NO. IF "NO" - FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "NO" -SEVERITY GREATER THAN USUAL? UNK. A DDI BOARD ASSEMBLY AND A DDI PROBE WERE SENT TO THE CUSTOMER.
X-TUBE ASSM 17" X 16". DEALER CLAIMS X-TUBE BROKE AT THE CENTER BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE PT WAS TREATED FOR A FRACTURED FEMUR PRIOR TO 8/12/94. ON 8/12/94, A DISTAL SCREW WAS REMOVED. IT IS ALLEGED THAT THE NAIL BROKE AT THIS TIME AND WAS REMOVED AFTER THIS PROCEDURE.
ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED FROM THE USER FACILITY. THE BASELINE REPORT SHALL BE SUBMITTED UPON RECEIPT OF THE COMPLETE CATALOG NUMBER WITH THE SUPPLEMENTAL MEDWATCH REPORT. THE DEVICE WAS NOT MANUFACTURED IN THE US. EVALUATION OF THIS EVENT IS TO BE PERFORMED AT THE MANUFACTUING FACILITY.
END USER HOSPITAL REPORTED THAT MICRO BUBBLES WERE PRESENT DURING ASPIRATIONS INVOLVING THE CO'S CATHETER. THERE WAS NO PT INCIDENT.
OR AXLE MAG W/NUT. DEALER CLAIMS THE BALL BEARINGS FELL OUT.
STAKING AT HOLE NOT SUFFICIENT TO RETAIN DETENT BALL. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO. DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WHILE SURGERY ROOM WAS BEING SET-UP, THE LISTED LIGHT SOURCE WHICH USES A "ZENON LAMP" EXPLODED - SENDING GLASS OUT OF THE BACK OF THE UNIT AND A SOUND DESCRIBED EQUAL TO A M-80 EXPLODING. UNIT IS USED FOR NEURO-SURGERY. UNIT HAS A LAMP WHICH IS KNOWN TO EXPLODE (AS INDICATED BY THE MFR) EARLY IN ITS LIFE OR AT ITS END. "THIS IS WHY WE ONLY USE FOR 500 HRS. THE UNIT IS NOT TO EXCEED 750 HRS OF USE OF ITS 1000 HR LIFE SPAN. THE CO "BURNS IN" USE OF 250 HRS BEFORE WE RECEIVE IT. WE DID NOT EXCEED OUR USE OF 500 HRS." RPTR IS CONCERNED WITH A UNIT THAT WOULD BE USED IN THE OR ENVIRONMENT WHICH POSES THE THREAT OF EXPLOSION.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WOULD NOT ADVANCE. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
A PHYSICIAN REPORTED A PT WHO WAS TREATED ON 7/30/96 TO THE NASOLABIAL FOLDS AND UPPER VERMILION BORDER. IN 8/96, EXACT DATE UNK, THE PT DEVELOPED FATIGUE, MUSCLE PAIN, ABDOMINAL DISCOMFORT AND LIGHT HEADEDNESS. SHE WAS HOSPITALIZED ON 11/4/96 FOR A WORK-UP. DECADRON WAS PRESCRIBED. ON 11/12/96. THE PT WAS STABLE AND DOING WELL. SHE WAS DIAGNOSED BY A RHEUMATOLOGIST WITH ADRENAL INSUFFICIENCY; HE WAS UNABLE TO PINPOINT THE CAUSE OF THE A DRENAL INSUFFICIENCY BASED ON SEVERAL UNSPECIFIED TESTS, WAS NOT SURE IF THERE WAS AN ASSOCIATION WITH THE COLLAGEN, BUT STATED IT WAS POSSIBLE. THE INJECTING PHYSICIAN DID NOT BELIEVE THE ADRENAL INSUFFICIENCY WAS RELATED TO COLLAGEN. NO SYMPTOMS AT THE INJECTION SITES WERE REPORTED.
THE SEVICE REP REPORTED THAT THE 3100A VENTILATOR DID NOT MEET A SPEC. HE COULD NOT ACHIEVE A MEAN AIRWAY PRESSURE (MAP) LESS THAN 12 CMH20 DURING ROUTINE RENTAL CHECKOUT. THERE WAS NO PT INVOLVEMENT AT ALL.
IS FREQUENCY ADDRESSED IN LABELING? NO. IF "NO" - FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "NO" - SEVERITY GREATER THAN USUAL? UNK. THE VENTILATOR WAS RETURNED TO THE FACTORY FOR ANLAYSIS. THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED.
THE DEVICE WAS APPLIED DURING A MASON PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
BURETROL HAS BROWN FIBROUS PARTICLES FLOATING AFTER BAG SPIKED. NEVER ATTACHED TO PT.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP. THE CLIP SPIITTED FROM THE JAW. (DID NOT FALL INTO PT) CASE WAS COMPLETED BY A NEW DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
H4:D5:D6: INFORMATION UNAVAILABLE.H6:CODE 400(OTHER): YEILDED JAWS.
DURING AN INGUINAL HERNIA PROCEDURE, THE TIP OF THE NEEDLE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/15/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
X-TUBE ASSM. A18" X 17" DEALER CLAIMS X-TUBE BROKE AT THE WELD.
THE INFUSION PUMP APPEARED TO BE OPERATING, HOWEVER NO FLUID WAS BEING ADMINISTERED. NO SPECIFIC PT INFO WAS RECEIVED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. EVALUATION SUMMARY: FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION. THE MOST LIKELY CAUSE OF THE REPORTED OCCURRENCE WAS IMPROPER LOADING OF THE IV TUBING BY THE USER. THE OPERATOR'S MANUAL INSTRUCTS TO "ENSURE THAT THE TUBING IS LOADED STRAIGHT THROUGH THE PUMP MECHANISM TUBING GUIDS AND SAFETY CLAMP." AND TO "CONFIRM FLOW BY CHECKING FOR DROPS IN THE I.V. SET DRIP CHAMBER." WHEN THE INFUSION IS STARTED.
IT WAS REPORTED THE EZ35W WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE INITIAL FIRING DID NOT CUT, BUT STAPLES WERE FORMED. THERE WAS NO BUTTRESSING MATERIAL USED. THERE WAS NO CONSEQUENCE TO THE PT.
H6:CODE 400: FIRING MECHANISM DAMAGED. RESULTS OF EVAL: BASED UPON INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT WAS RETURNED NON-FUNCTIONAL. INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDE, FIRING PRIOR TO COMPLETE CLAMPING OF JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
A PHYSICIAN REPORTED A PT WHO WAS TREATED IN THE GLABELLA ON 10/18/96. ON 10/18/96, THE PT DEVELOPED SYMPTOMS AT THE GLABELLA. ON 10/20/96, THE GLABELLA WAS INTENSELY INFLAMED AND PAINFUL; AN UNSPECIFIED MEDICATION WAS PRESCRIBED. ON 10/22/96. THE AREA WAS INFLAMES WITH AN ESCHAR AND INTERRUPTION OF THE SKIN IN WHICH FRAGMENTED COLLAGEN APPEARED; THE PHYSICIAN TRIED TO REMOVE THIS WITH STERILE PINCERS. THE AREA WAS DISINFECTED, MEDICATED WITH A FATTY OINTMENT AND BANDED. AN ANTIBIOTIC INJECTION WAS GIVEN.
FOLLOW UP INFO RECEIVED ON 5/13/97 INDICATED THAT THE SYMPTOMS HAD IMPROVED ALMOST COMPLETELY. 1971 NECROSIS INJECTION SITE. 2060 SCAR.
THE DEVICE WAS USED DURING A COLOSTOMY. IT WAS REPORTED BY THE REP SMALL FISTULA AFTER STAPLING. FISTULA WAS CLOSED. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6;H3,4,6;G4: ADDED ADDITIONAL INFO. D6; DEVICE RETURNED WITH NO LOT ID. BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RELOADED AND FIRED. IT FIRED AND FORMED STAPLES AS DESIGNED AROUND THE ENTIRE STAPLE RING WITH NO DIFFICULTIES NOTED. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT.
A PHYSICIAN REPORTED A PT WHO WAS TREATED AT THE END OF 9/96 TO THE UPPER LIP AND NASOLABIAL FOLDS. THE END OF 10/96, THE PT DEVELOPED INDURATION AND REDNESS AT THE TREATMENT SITES. SHE ALSO DEVELOPED JOINT PAIN (ONSET UNK); AND ORAL MEDICATION WAS PRESCRIBED. THE PHYSICIAN BELIEVED THE SYMPTOMS WERE RELATED TO COLLAGEN.
THE PHYSICIAN REPORTED IMPROVEMENT WITH STEROIDS, AND THE SYMPTOMS RESOLVED IN JANUARY 1997.
DURING A ILEOANAL ANASTOMSIS PROCEDURE, INSTRUMENT DID NOT CUT. THE SURGEON MANUALLY COMPLETED THE PROCEDURE. THE HOSP REPORTED THAT NO PT INJURY OCCURRED.
REAR S/F DAB PAINTED R Q2. DEALER CLAIMS FRAME BROKE AT THE WELD.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS. INC OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED AS PART OF A BSSC. THE INSTRUMENT IS JUST FIRING THE CLIPS OUT LIKE BULLETS FROM A GUN. THERE WAS NO CONSEQUENCE TO ANYONE.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. DOES NOT FIRE/MISFIRE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFO UNAVAILABLE. D5,6;H4,6; INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
HE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THAT THE CLIPS FELL OUT. THERE WAS NO CNSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10; INFO UNAVAILABLE. D5,6;H4,6; INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
DURING A LUNG REDUCTION PRCEDURE INSTRUMENT WOULD NOT FIRE. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
ATTEMPTED STENT PLACEMENT UNSUCCESSFUL. STENT IN CORONARY ARTERY BUT NOT DEPLOYED.
X-TUBE ASSM 20" X 16". DEALER CLAIMS X-TUBE BROKE CRACKED AT WELD.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THIS REPORT IS NOT FOR A FIELD EVENT. THE MALFUNCTION OCCURRED DURING CO'S EVALUATION TEST WHICH IS PART OF THE NORMAL SERVICE/REPAIR PROCEDURE. AN ANALGESIA GAS MACHINE (FLOWMETER) WAS RETURNED FOR REPAIR WITH A NOTED STATING TO "ESTIMATE FOR REPAIR". THE UNIT WAS RECEIVED ON 9/23/96. UPON EVALUATION IT WAS DETERMINED THAT THE FLOWMETER COULD FLOW NITROUS OXIDE (N2O) WITHOUT OXYGEN (O2). THIS INSTRUMENT IS DESIGNED TO DELIVER MIXED O2 AND N20 TO A DENTAL PT. WHEN O2 FLOW OR PRESSURE IS NOT PRESENT, THE INSTRUMENT HAS A FEATURE WHICH STOPS THE FLOW OF N2O. THIS FEATURE, THEREFORE, HAD MALFUNCTIONED. CO'S FOLLOW-UP REPORT OF THE DEALER CONTACT STATES "THERE WAS NO PT INCIDENT WHICH OCCURRED, THE UNIT WAS OWNED BY THE DEALER AND WAS PURCHASED FROM A DR WHO HAD IT IN STORAGE FOR 5 YRS. " THEREFORE, AT NO TIME DID A PT RECEIVE 100% N2O FROM THIS DEVICE AS A RESULT OF THIS MALFUNCTION. CO HAS PREVIOUSLY SUBMITTED MDR'S WHEN THE FAILSAFE HAS MALFUNCTIONED, EVEN WHEN ONLY IN CO'S TEST AS IN THE CASE OF THIS MDR. UNDER THE CURRENT MDR REGULATIONS, CO HAS DETERMINED THAT THIS CATEGORY OF PRODUCT MALFUNCTION DOES NOT REQUIRE SUBMISSION OF AN MDR AND HAS FILED AN EXEMPTION WITH THE FDA ON 11/6/96.
QUALITY DEPT, AS A MATTER OF POLICY, REVIEWS UNITS RETURNED FOR REPAIR, AND ALSO INVESTIGATES COMPLAINTS. SUBJECT COMPLAINT CONCERNS A MALFUNCTION CATEGORY PREVIOUSLY DEFINED AS REQUIRING FILING OF AN MDR. CO'S REGULATORY AFFAIRS REVIEW GROUP HAS REVIEWED ALL INFO THAT IS REASONABLY AVAILABLE IN A TIMELY MANNER AND DETERMINED NOT TO SUBMIT AN MDR. CO HAS DECIDED TO SUBMIT THIS MDR DETERMINATION TO FDA FOR REVIEW. REGULATORY AFFAIRS REVIEW GROUP'S DETERMINATION IS BASED ON A REVIEW THAT A MALFUNCTION WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. AS PROVIDED IN 21 CFR 03.16, THIS REPORT OR OTHER INFO RECORDED BY CO UNDER 21 CFR PART 803, DOES NOT NECESSARY REFLECT A CONCLUSION BY CO THAT REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, OR CO OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT. CO NEED NOT ADMIT AND MAY DENY THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, CO, OR EMPLOYEES THEREOF, CAUSED OR CONTRIBUTED TO A EVENT. THIS ANALGESIA GAS MACHINE (FLOWMETER) WAS ORIGINALLY SHIPPED ON 2/28/79. DEVICE HISTORY SHOWS THAT IT HAS NEVER BEEN RETURNED FOR SERVICE/REPAIR SINCE ITS ORIGINAL SHIPMENT IN 1979. UNIT WAS FURTHER EVALUATED BY ENGINEERING ON 9/27/96. TEST PROCEDURE TP-102 PRODUCED REPORTED COMPLAINT OF N2O WITHOUT O2, EVEN USING EXTENDED DYNAMIC TEST AT 60 PSIG 02 PRESSURE AND 40 PSIG N2O PRESSURE. THIS TEST IS KNOWN TO PRODUCE FULL POPPET PIN DEPRESSION AND IS CONSIDERED TO BE A SEVERE TEST OF POPPET PERFORMANCE. IT IS ONE OF THE TESTS PERFORMED ON 100% OF THE NEW PRODUCTION UNITS. A COMPLETE DISASSEMBLY OF THE UNIT WAS THEN DONE, FOLLOWING THE SAME PROCEDURE THAT HAS BEEN DEVELOPED OVER THE COURSE OF EVALUATIONS OF OTHER FAILSAFE MALFUNCTIONS. THERE WAS NO INDICATION OF VISIBLE DAMAGE TO THE UNIT. BASED UPON THIS EXAMINATION, THE CAUSE OF MALFUNCTION WAS DETERMINED TO FALL UNDER LACK OF SUFFICIENT LUBRICATION CATEGORY. UNIT'S FAILSAFE BLOCK WAS REPAIRED AS NEEDED, RP-102 WAS PERFORMED (PROCEDURE FOR RECONDITIONING MXR FLOWMETERS), THEN IT WAS TESTED IN USUAL MANNER AND RETURNED TO CUSTOMER. CO RECOMMENDS A TWO YR CYCLE TO HAVE A MXR FLOWMETER FACTORY CHECKED AND SERVICED. IT IS ALSO RECOMMENDED THAT BETWEEN SERVICING INTERVALS TO SAFEGUARD AGAINST POTENTIAL MALFUNCTIONS BY PERFORMING FAILSAFE CHECK BEFORE EACH AND EVERY USE OF UNIT THIS UNIT HAD NOT BEEN SERVICED OR EVALUATED BY CO SINCE IT'S ORIGINAL SHIPMENT IN 1979. NO FURTHER ACTIONS ARE REQUIRED. CO CONCLUDES THAT PREVIOUS ACTIONS TO MINIMIZE FAILSAFE MALFUNCTIONS ARE STILL VALID AND THIS MDR EVALUATION DOES NOT LEAD TO ANY DIFFERENT CONCLUSION OR NEW ACTIONS. CO BELIEVES THAT UNDER SECTION 803.20 (C), THIS CATEGORY OF MALFUNCTION IS EXEMPT FROM FUTURE MDR REPORTING AND HAS SUBMITTED A MDR EXEMPTION REPORT TO FDA ON 1/6/96. PORTER WILL SUBMIT SIMILAR MDRS UNTIL IT IS NOTIFIED OTHERWISE BY THE FDA.
THE DEVICE WAS USED DURING UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP, WOULD NOT OPEN/CLOSE. THERE WAS NO CONSEQUENCE TO THE PT.
INFANT HAD PROSTHETIC MITRAL VALVE PLACED. ON ROUTINE PHYSICAL EXAM AND ECHOCARDIOGRAM, ONE OF THE LEAFLETS HAD BECOME "STUCK" IN THE CLOSED POSITION, THIS CREATING MITRAL VALVE STENOSIS. WILL REQUIRE OPERATIVE REPLACEMENT.
DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE, THE STAPLES DID NOT LOCK PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE 3100A VENTILATOR MEAN AIRWAY PRESSURE (MAP) WAS READING - 18 CMH20 AND COULD NOT BE ADJUSTED INTO A NORMAL RANGE. THERE WAS NO PT INVOLVEMENT AT ALL.
IS FREQUENCY ADDRESSED IN LABELING? NO. IF "NO" - FREQUENCY GREATER THAN USUAL? UNK. IS SEVERITY ADDRESSED IN LABELING? NO. IF "NO" - SEVERITY GREATER THAN USUAL? UNK. THE UNIT WAS RETURNED TO THE FACTORY FOR ANALYSIS. TEST METHOD: THE UNIT WAS VISUALLY INSPECTED FOR DEFECTS. IT WAS ALSO TESTED PER THE PRODUCTION TEST PROCEDURE 768914 AND THE RENTAL TEST/INSPECTION PROCEDURE IP-767996. ANALYSIS: THERE WERE NO VISUAL DEFECTS. WHILE TESTING WAS BEING PERFORMED, IT WAS NOTICED THAT PIN 2 IN THE 917 CONNECTOR TO THE ALARM BOARD WAS LOOSE CAUSING AN INCORRECT SIGNAL TO THE PRESSURE TRANSDUCER. CONCLUSION: THE COMPLAINT WAS VERIFIED. THE LOOSE PIN IN THE MAIN HARNESS CONNECTOR CAUSED AN INCORRECT SIGNAL TO BE SENT TO THE PRESSURE TRANSDUCER CAUSING THE MAP DISPLAY TO READ -18CMH20. CORRECTIVE ACTION: THE PIN WAS SECURELY REATTACHED TO THE CONNECTOR BY THE SENSORMEDICS RENTAL SERVICE DEPT AND THE PRODUCTION AND RENTAL TEST/INSPECTIONS WERE PERFORMED. THE VENTILATOR WAS RETURNED TO THE RENTAL POOL.
NO LOT NUMBER WAS REPORTED SO DEVICE HSITORY COULD NOT BE SEARCHED. PRIMARY MATERIAL OF CONSTRUCTION IN THIS DRAPE IS THE DEVICE NONWOVEN. DEVICE CONFORMS TO THE APPLICABLE FEDERAL STANDARD FOR CLOTHING TEXTILES. NO SPECIMEN OF DEVICE HAS EVER FAILED TO FALL INTO THE "NORMAL FLAMMABILITY" CLASSIFICATION. CO'S LABELING STATES - "CAUTION: THE CONTENTS OF THIS PACKAGE, AS WITH ANY LINEN OR DISPOSABLE DRAPE AND GOWN MATERIAL, MAY BURN IF EXPOSED TO A FLAME OR EXTREMELY HOT OBJECT. AVOID CONTACT WITH AN OPEN FLAME OR HIGH INTENSITY HEAT SOURCES. DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHESIA."
X-TUBE ASSM 18" X 16". DEALER CLAIMS X-TUBE BROKE AT WELD BELOW SEAT TUBE.
A PHYSICIAN REPORTED A PT WHO WAS TREATED ON 9/7/94 INTO THE UPPER VERMILION BORDER, NASOLABIAL FOLDS AND ORAL COMMISURES. SHE IMMEDIATELY DEVELOPED A WHITE, PEA-SIZED BUMP AT THE RIGHT UPPER VERMILION BORDER TREATMENT SITE. THE PHYSICIAN BELIEVED THE BUMP WAS THE COLLAGEN MATERIAL AND INSTRUCTED THE PT TO APPLY WARM AND COOL COMPRESSES AND TO MASSAGE THE AREA. IN APPROXIMATELY 6/95, THE BUMP BECAME BIGGER IN SIZE; THE PT DENIED INFLAMMATION OR ITCHING. IN APPROX 9/95 THE BUMP STABILIZED IN SIZE; THE PT WAS SEEN ON 11/12/96 WITH WHITE, KELOID-LIKE SCAR TISSUE AT THE RIGHT UPPER VERMILION BORDER. THE PHYSICIAN DID NOT BELIEVE THE PT HAD EXPERIENCED A HYPERSENSITIVITY BUT DID NOT KNOW AN ETIOLOGY FOR THE SCAR FORMATION.
INITIAL INFO WAS INITIALLY RECEIVED FROM RN DURING A TELEPHONE CONVERSATION ON 8/19/96. A MEDWATCH FORM WAS RECEIVED FROM THE INSTITUTION ON 9/11/96. SECTIONS A,B,E & F OF THIS FORM IS INFO WHICH WAS SUBMITTED TO CO ON THE MEDWATCH FORM. INFO RECEIVED FROM RN IS AS FOLLOWS: THE CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY. UPON INFLATION, THE DELIVERY BALLOON BURST AT 4 ATMOSPHERES. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION AND IT WAS NOTED THAT THE STENT WAS MISSING. THE PHYSICIAN BELIEVED THE STENT HAD EMBOLIZED IN THE TARGET VESSEL, BUT WAS UNABLE TO CROSS THE STENT WITH AN ADD'L CATHETER. THE PT HAD GOOD BLOOD FLOW IN THE VESSEL AND WAS ASYMPTOMATIC. THE DECISION WAS MADE TO SEND THE PT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. INSTITUTION INDCATED THAT THE DEVICE WAS NOT AVAILABLE FOR EVAL; HOWEVER, THE DEVICE  WAS RECEIVED FOR EVAL ON 8/26/96.  RESULT CODE: 400-PRODUCT EVAL REVEALED AN INTACT BALLOON WHICH INFLATED TO 8 ATMS. A LEAK WAS NOTED IN THE KYNAR COATING OF THE INNER MEMBER OF THE DEVICE WHICH DID NOT PREVENT BALLOON EXPANSION DURING THE FUNCTIONAL TESTING OF THE DEVICE.
ALL INFO IN SECTIONS A,B,D,E AND F WERE NOT PROVIDED INITIALLY BY THE USER FACILITY AND MFR IS PROVIDING THIS INFO BASED ON CASE INVESTIGATION. ANY INFO NOT PROVIDED IS UNK OR UNAVAILABLE TO THE USER FACILITY. INSPECTION OR THE DEVICE REVEALED THAT THE BUR WAS NOT FULLY INSERTED WHEN THE DRILL WAS RUN. BECAUSE THE BUR WAS NOT FULLY INSERTED, EXCESS WHIP OCCURRED WHEN IT WAS RUN. THIS CAUSED THE BUR TO BREAK.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SAFETY SHIELD WOULD NOT RETRACT. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/13/96-MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THAT THE CLIPS WOULD NOT HOLD AND CLIPS FELL OUT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10; INFO UNAVAILABLE. D5,6;H4,6; INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. INGO FOR D1 THROUGH D10 IS THE SAME FOR INSTRUMENT #2. INFO FOR H1 THROUGH H10 IS THE SAME FOR INSTRUMENT #2.
X-TUBE ASSM 19" X 18" DEALER CLAIMS X-TUBE BROKEN AT THE BOLT HOLE.
DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNKNOWN OR UNAVAILABLE. DEVICE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
THE DEVICE WAS USED DURING A THORACIC PROCEDURE. IT WAS REPORTED BY THE REP. THE ENDO LINEAR CUTTER DID NOT FIRE AND THE SURGEON COULD NOT RELEASE THE HANDLE, THEREFORE THEY HAD TO FORCE IT OPEN AND THEN THEY PROCEEDED TO USE A TLC7 TO FINISH THE PROCEDURE. INSTRUMENT BEING RETURNED FOR EVAL. THERE WAS NO CONSEQUENCE TO THE PT.
H6; EVALUATION CODE #400(OTHER): FIRING MECHANISM DAMAGED. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
INVESTIGATION/CONCLUSION: THE UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPROTED COMPLAINT WAS CONFIRMED, THE CAUSE OF WHICH WAS THE ROTARY VALVE. CO HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE TEC 6 VAPORIZER. AS A RESULT, THE FREQUENCY OF OCCURRENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED U.S. BASE IN FISCAL YEAR 1996 FROM 0.4% IN 1994. CO WILL CONTINUE TO MONITOR THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER MATERIALS AND/OR PROCESS MODIFICATIONS.
REAR S/F DAB HEMI PNTD R Q2. DEALER CLAIMS REAR SIDE FRAME IS BROKEN AT UPPER WELD.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
A STOPCOCK ON A UAC LINE CRACKED CAUSING LOSS OF BLOOD IN AN 11-DAY OLD INFANT. THE PT'S HCT DROPPED TO 22 DURING THIS EVENT. A TRANSFUSION WAS DONE WHICH BROUGHT IT TO 28. A SECOND TRANSFUSION WAS REQUIRED. THE INFANT RECOVERED.
STAFF MEMBERS WERE TREATING A PT (AGE AND GENDER UNKNOWN) WHO REQUIRED DEFIBRILLATION DURING A SURGICAL PROCEDURE. THE UNIT DID NOT CHARGE. THE STAFF OBTAINED ANOTHER SET OF INTERNAL PADDLES AND DEFIBRILLATED THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT.
THE PRODUCT DID NOT PASS MFR TESTING. THE PRODCUT WAS SCRAPPED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED THORACOSCOPIC PROCEDURE. REPORTEDLY, THE INSTRUMENT CUT AND DID NOT STAPLE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
WHILE NURSE WAS WORKING IN LABOR AND DELIVERY, SHE DEVELOPED HIVES, AND RASH ON HER HANDS. SHE CHANGED GLOVES AND HER SKIN PROBLEMS STOPPED. IN THE LAST 6 - 8 MONTHS SHE DEVELOPED ASTHMA. DURING THIS PERIOD OF TIME, SHE WAS USING LATEX GLOVES. ON 8/12/96, HER DR. PRESCRIBED SOME MEDICATIONS DUE TO HER ALLERGIC REACTIONS. NURSE WAS TAKING ALL MEDICATIONS AND STARTED TO USE NON-LATEX GLOVES. BUT ONE DAY WHILE TAKING CARE OF A PT, SHE DEVELOPED RUNNY NOSE, SHORTNESS OF BREATH, WATERY EYES, WHEEZING, ETC. AN INHALER WAS PROVIDED AND AN EXTRA DOES OF ANTIHISTAMINE WAS ADMINISTERED. AT THIS TIME PT WAS USING NON LATEX GLOVES AND NON-LATEX MASK. ON 8/24/96 BETWEEN 5:30 - 6:15AM SHE DEVELOPED ANOTHER REACTION AND HER SUPERVISOR WAS NOTIFIED. EVEN THOUGH PT SWITCHED TO A NON-LATEX GLOVE, EACH TIME SHE GOT IN CONTACT WITH SOMEONE THAT IS USING LATEX GLOVES SHE GOT AN ALLERGIC REACTION. SHE IS NO LONGER WORKING AS AN RN BUT IS ACTUALLY WORKING AT THE MEDICAL RECORDS OFFICE.
THE INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTED DID NOT PROVIDE ANY CATALOG OR LOT NUMBER INFO.
THE DEVICE WAS USD DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP ONLY INFO RECEIVED TO DATE IS THAT THE STAPLES COLLAPSED WHEN FIRED. ONE USED INSTRUMENT BEING RETURNED FOR EVAL. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: BASED ON THE INFORMATION RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT WAS CONCLUDED THAT THE RETAINING PIN WAS NOT PUSHED FULLY FORWARD INTO THE ANVIL HOLE PRIOR TO FIRING THE INSTRUMENT. THIS IS EVIDENCED BY THE VISIBLE DAMAGE TO THE INSTRUMENT. AS THE INSTRUMENT IS SHIPPED IN THE LOCKED OUT POSITION, IT IS VERY IMPORTANT THAT THE RETAINING PIN MUST BE FULLY FORWARD AND COMPLETELY INTO THE ANVIL HOLE PRIOR TO DIALING THE ADJUSTING KNOB INTO FIRING RANGE. IT IS IMPERATIVE THAT THE GREY RETAINING PIN TAB BE FULLY FLUSH AGAINST THE DISTAL END OF THE TRACK. THIS WILL UNLOCK THE INSTRUMENT AND ALLOW IT TO PERFORM AS DESIGNED. IT SHOULD ALSO BE NOTED THAT IF THE RETAINING PIN IS NOT FULLY FORWARD, IT WILL CAUSE THE STAPLES TO NOT ALIGN PROPERLY WITH THE ANVIL CAUSING THE STAPLES TO BE MALFORMED. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP, THE INSTRUMENT DOES NOT FIRE/MISFIRE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D10: INFO NOT PROVIDED BY AFFILIATE. D5,6;H4,6: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE FOLLOWING INFO WAS OBTAINED UPON FOLLOW-UP WITH THE ACCOUNT: THE LEAKAGE OF THE REPORTED DEVICE WAS NOTED WHEN THE HEALTH CARE PROVIDER NOTICED THE PT'S BED WAS "SOAKED" WITH BLOOD. PT WAS A 32 PREEMIE AND REQUIRED A BLOOD AND PLASMA TRANSFUSION. THE SOLUTION THAT WAS BEING INFUSED AT THE TIME OF THE INCIDENT WAS LIPIDS, CRACKING MAY OCCUR."
X-TUBE ASSM 18" X 16" DEALER CLAIMS X-TUBE BROKE AT CENTER BOLT. CUSTOMER WAS IN CHAIR WHEN IT BROKE.
MEDICS WERE MONITORING A PT DURING A TRANSPORT AND THE UNIT'S MONITOR SCREEN DISPLAY BECAME ERRATIC. THE COMPLAINANT INDICATED THAT THE ALLEGED MALFUNCTION WAS INTERMITTENT. THE MEDICS RAN STIPS TO MONITOR THE PT'S RHYTHM. THERE WAS NO ADVERSE EFFECT ON THE PT.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN AFTER FIRING. THE SURGEON MANUALLY MANIPULATED THE JAWS OPEN. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP WON'T HOLD/CLOSE CLIP OR DOES NOT FIRE/MISFIRE. THERE WAS NO CONSEQUENCE TO THE PT.
11/13/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
THE CUSTOMER'S SON REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH TEST STRIPS, LOT #1M507B. THE CUSTOMER'S HOME NURSE PERFORMED SEVERAL BLOOD GLUCOSE TESTS AND THE RESULTS WERE IN THE 10/20 MG/DL RANGE. SHE DID NOT BELIEVE THESE READINGS TO BE CORRECT, SO SHE PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS OUT OF RANGE ON THE LOW END (NO SPECIFIC RESULT AVAILABLE). THE CONTACT STATED THAT HE THINKS THE NORMAL CONTROL SOLUTION TEST RESULT WAS REALLY LOW, 8 OR 10 MG/DL. THE NURSE ALSO PERFORMED A  CHECK STRIP TEST AND THE RESULT WAS IN RANGE (NO SPECIFIC RESULT AVAILABLE). THE DESICCANT IS IN THE BOTTLE OF DEVICE. THE CUSTOMER STORES THE TEST STRIPS IN HER LIVING ROOM. BECAUSE THE CONTACT DOES NOT USUALLY PERFORM HIS MOTHER'S BLOOD GLUCOSE TESTS, HE DID NOT FEEL COMFORTABLE PERFORMING ANY CONTROL TESTS WITH THE CO'S REPRESENTATIVE.
THE CUSTOMER RETURNED TEST STRIPS WERE EVALUATED ON 11/11/96. TWO OPENED BOTTLES WERE RETURNED WITH NO DISPLAY BOX. ONE BOTTLE CONTAINED 9 TEST STRIPS WITH DESICCANT. THE DATE THE BOTTLE WAS OPENED HAD NOT BEEN RECORDED, THE LABEL WAS DISCOLORED YELLOW AND ALL STRIPS APPEARED DARK GREY WITH BLUE SPOTS INDICATING THEY HAD BEEN EXPOSED TO MOISTURE (SOURCE UNK). THE TEST STRIPS FROM THIS BOTTLE DID NOT MEET SPECIFICATIONS FOR ACCURACY. THE SECOND BOTTLE WAS RETURNED OPENED IN THE ENVELOPE AND THE CAP WAS SEPARATED FROM THE BOTTLE. NINETEEN STRIPS AND ONE DESICCANT WERE FOUND LOOSE OUTSIDE THE BOTTLE. THE STRIPS APPEARED GREY AND THE LABEL HAD BEEN TORN. THE STRIPS THAT WERE FOUND LOOSE IN THE ENVELOPE DID NOT MEET SPECIFICATIONS FOR ACCURACY. THE EVALUATION OF DESICCANT FROM BOTH BOTTLES INDICATES THAT THE FAILURE OF THE TEST STRIPS WAS DUE TO EXPOSURE TO MOISTURE. THE SOURCE OF MOISTURE EXPOSURE FOR BOTTLE #1 IS UNK. HOWEVER, RESULTS FOR BOTTLE #2 RESULT FROM THE EXPOSURE WHILE LOOSE IN THE SHIPPING ENVELOPE. RETENTION SAMPLES FOR LOT 1M507B WERE COMPARED TO REFERENCE METHOD (YSI) AND MEET ALL SPECIFCATIONS FOR ACCURACY AND PRECISION. CONTROL VALUES WERE WITHIN RANGE. CO CONFIRMED THE CUSTOMER'S COMPLAINT AND CONCLUDES THAT THE PROBLEM MAY LIKELY HAVE BEEN DUE TO IMPROPER USE AND HANDLING BASED ON THE CONDITION OF THE RETURNED PRODUCT. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
X-TUBE ASSM 17" X 16" DEALER CLAIMS X-TUBE BROKE AT CENTER BOLT HOLE.
ON 10/21/96 UPON REMOVAL OF THE DRAIN A PORTION OF APPROX. 8CM FRACTURED OFF AND REMAINED IN THE PT'S WOUND. PT WAS TAKEN TO SURGERY FOR THE REMOVAL OF THE FRRACTURED DRAIN PORTION.
ON 11/4/96 THE SAMPLE WAS SENT FOR STERILIZATION DECONTAMINATION. AFTER STERILIZATION THE SAMPLE WILL BE FORWARDED TO THE MANUFACTURING FACILITY FOR AN EVAL.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP DOES NOT FIRE/MISFIRE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFO NOT PROVIDED BY AFFILIATE. D5,6;H4,6: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP THE STAPLES WERE NOT ADVANCING. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: AB)BASED UPON THE INQUIRY INFO RECEIVECD, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST; A)IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING WITH REGARD TO STAPLES FEEDING, FIRING AND FORMING. THE INSTRUMENT WAS RECEIVED WITH THE TUBE DENTED. THE INSTRUMENT WAS EXAMINED AND WAS FOUND TO BE FUNCTIONAL AND WAS CYCLED, FIRED, AND PROPERLY FORMED THE REMAINING STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT'S "STAPLES WERE NOT ADVANCING" DURING SURGERY. THE INSTRUMENT WAS RECEIVED EMPTY AND NO FUNCTIONAL TESTING COULD BE PERFORMED. NOTE:IT WAS ORIGINALLY REPORTED THAT 1 INSTRUMENT WAS BEING RETURNED, BUT 2 INSTRUMENTS WERE RECEVIED. COMMENTS: AB)EACH INSTUMENTS IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY.
RECEIVED CALL FROM NURSE REPORTING SUSPECTED PUMP MALFUNCTION. SHE STATES THAT PT DOESN'T RECEIVE BOLUS DOSE WHEN BUTTON IS ACTIVTED. ALSO, PT REPORTED THAT "PUMP SPINNING FOR 20 MINS" AND THAT SHE EXPERIENCED INCREASED EUPHORIA AND FATIGUE. NURSE REPORTS THAT PUMP IS ALWAYS IN LOCK LEVEL 2. MEDICATION IS MORPHINE SULFATE 2MG/ML WITH DOSE OF 2MG/HR AND BOLUS 2MG EVERY 6 MINS IF NEEDED.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE THE TISSUE. THE SURGEON APPLIED ANOTHER INSTRUMENT. NO PT INJURY REPORTED.
THE DEVICE WAS APPLIED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON APLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
X-TUBE ASSM 18" X 18". ADEALER CLAIMS X-TUBE BROKE AT CENTER HOLE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC.UNDER 21 CFR PART 803, AND ANY RELEASE BYT HE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP CLIPS FELL OUT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B3,6,7;D10: INFO NOT PROVIDED BY AFFILIATE. D5,6;H4,6: INFO UNAVAILABLE, DEVICE NOT RETURNED TO ANALYSIS.
PLANTIFF ALLEGES SUFFERING PHYSICAL INJURIES INCLUDING BUT NOT LIMITED TO HIVES, WHEEZING, HAND DERMATITIS, RUNNY NOSE, DIZZINESS, FLU-LIKE SYMPTOMS, AND OTHER PHYSICAL INJURIES, LOSS OF ENJOYMENT OF LIFE, ALL OF WHICH ARE A PERMANENT AND CONTINUING AND LIFE-THREATENING NATURE DUE TO THE EXPOSURE OF LATEX. PLAINTIFF ALLEGES LOSS OF CONSORTIUM.
INVESTIGATION COULD NOT BE PERFORMED AS THE REPORTED DID NOT PROVIDE ANY PRODUCT OR LOT NUMBER INFO. LITIGATION PENDING. NO CUSTOMER CONTACT ALLOWED.
THIS IS CASE #2 OF 2 IN WHICH THE SET BLEW APART DURING INJECTION OF CONTRAST MEDIA INTO A PATIENT IN THE CAT SCAN AREA. CASE #2: THE IMAGING AGENT WAS SPRAYED OVER THE ROOM. DOSAGE OF AGENT DELIVERED TO THE PATIENT WAS NOT KNOWN. NO PATIENT ILL EFFECTS WERE REPORTED ALTHOUGH THE PROCEDURE HAD TO BE REPEATED.NOTE: HIGH PRESSURE INJECTION TUBING SHOULD BE USED FOR HIGH PRESSURE INJECTION OF CONTRAST AGENTS. THIS SET IS NOT RECOMMENDED FOR SUCH PROCEDURES.
CONTRAST MEDIA IS INJECTED BY A HIGH PRESSURE INJECTOR, AND THIS TUBING IS NOT RECOMMENDED FOR HIGH PRESSURE INJECTION. RUPTURE OF THE TUBING CAN BE ANTICIPATED IF USED FOR SUCH PURPOSES.HIGH PRESSURE INJECTION TUBING IS AVAILABLE FOR INJECTION OF CONTRAST MEDIA.
DEVICE WAS NOT CLINICALLY APPLIED. THE VISIBILITY WAS NOT CLEAR DURING PREPARATION FOR SURGERY.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP, DOES NOT CUT. THERE WAS NO CONSEQUENCE TO THE PT.
DURING THE ADVANCEMENT ATTEMPT OF A ENDOVASCULAR STENT MOUNTED ON ANOTHER MFR'S BALLOON CATHETER THROUGH THE BRACHIAL ARTERY TOWARD THE TARGET LESION SITE IN THE PT'S RENAL ARTERY, THE STENT EMBOLIZED. THE PHYSICIAN FULLY DEPLOYED THE EMBOLIZED STENT IN THE PT'S BRACHIAL ARTERY AND CONTINUED TO SUCCESSFULLY PLACE A ENDOVASCULAR STENT AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED.
THE BALLOON-EXPANDABLE STENT IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY.
DEVICE WAS NOT CLINICALLY APPLIED. THE SURGEON NOTICED THE VISIBILITY WAS NOT CLEAR PRIOR TO SURGERY.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP SHORT COUNT/EMPTY. THERE WAS NO CONSEQUENCE TO THE PT.
THE MONITOR WAS STUCK AND SEPARATED FROM THE BASE WHILE THEY WERE ATTEMPTING TO POSITION (TILT) THE MONITOR.
THE PT REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS AND HIGHER BLOOD GLUCOSE READINGS WITH DEVICE, LOT 16136A. UPON INITIAL OPENING, THE PT PERFORMED A NORMAL CONTROL SOLUTION TEST AND OBTAINED A RESULT THAT WAS WITHIN THE NORMAL CONTROL SOLUTION RANGE (NO SPECIFIC RESULT AVAILABLE). HE DOES NOT KNOW THE LOT NUMBER OF THE CONTROL SOLUTION HE USED AT THIS TIME. THE PT FELT THAT HE WAS OBTAINING ACCURATE BLOOD GLUCOSE READINGS UNTIL ONE WEEK AGO WHEN HE OBTAINED THREE CONSECUTIVE BLOOD GLUCOSE READINGS (AT DIFFERENT TIMES, ON DIFFERENT DAYS) OF OVER 180 MG/DL. HIS TYPICAL BLOOD GLUCOSE READINGS THE PREVIOUS WEEK WITH DEVICE WERE IN THE 120 MG/DL RANGE. BECAUSE HE FELT THE 180 MG/DL READINGS WERE SIGNIFICANTLY HIGHER, HE PERFORMED TWO BACK TO BACK NORMAL CONTROL SOLUTION TESTS. HE OBTAINED TWO NORMAL CONTROL SOLUTIONS TEST RESULTS OF 181 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 111-167 MG/DL (SOLUTION LOT VE185, EXP 5/97). THE PT SHOOK THE CONTROL SOLUTION BEFORE HE APPLIED THE SAMPLE TO THE TEST PAD. THE CONTROL SOLUTION WAS OPENED APPROX ONE MONTH AGO. WITH THE REPRESENTATIVE, THE PT OBTAINED A NORMAL CONTROL SOLUTION RESULT OF 182 MG/DL. WHEN THE REPRESENTATIVE SPOKE WITH THE PT, NO DESICCANT WAS PRESENT IN THE DEVICE BOTTLE. THE PT STATED THAT HE DID NOT REMOVE THE DESICCANT FROM THE BOTTLE, BUT DOES NOT REMEMBER WHETHER DESICCANT WAS PRESENT IN THE BOTTLE UPON INITIAL OPENING. WITH THE REPRESENTATIVE, THE PT OBTAINED A CHECK STRIP RESULT OF 75 VERSUS A CHECK STRIP RANGE OF 68-92. THE PT STORES THE TEST STRIPS IN HIS BEDROOM.
CO IS UNABLE TO CONFIRM THIS COMPLAINT BASED ON RETENTION SAMPLE TEST RESULTS. LOT 16136A WAS COMPARED WITH REFERENCE METHOD (YSI) AND MET ALL SPECIFICAITONS FOR ACCURACY AND PRECISION. CONTROL VALUES WERE WITHIN RANGE. REVIEW OF DEVICE HISTORY RECORDS INDICATE NO MISSING DESICCANT DURING INSPECTION AND PACKAGING OF THIS LOT. CUSTOMER COULD NOT BE DEFINITE AS TO WHETHER DESICCANT WAS PRESENT UPON OPENING. CO CANNOT CONCLUDE WHY CUSTOMER OBTAINED THESE RESULTS. CUSTOMER STATED THAT THE BOTTLE HAD BEEN OPENED APPROX ONE MONTH AGO. IF DESICCANT WERE MISSING THROUGH A PERIOD OF ONE MONTH, CUSTOMER WOULD HAVE CAPTURED LOWER BLOOD GLUCOSE READINGS. SINCE THE RESULTS FROM ALL THE RETENTION SAMPLE TESTS DO NOT CONFIRM THE FAILURE OF THE PRODUCT, THE RISK OF PRODUCT FAILURE IN THE FIELD IS LOW. IS EVENT OCCURRING MORE FREQUENTLY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRING MORE FREQUENTLY THAN IS USUAL FOR DEVICE? NO. IS EVENT OCCURRING WITH GREATER SEVERITY THAN STATED IN LABELING? NOT STATED. IS EVENT OCCURRING WITH GREATER SEVERITY THAN IS USUAL FOR DEVICE? NO. SUBMISSION OF THE MEDICAL DEVICE REPORT (MDR) DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT OR THAT THE INFO PROVIDED IS VALID.
THE GENERATOR "SELF-ACTIVATED AND SOMETIMES DOES NOT SHUT OFF." NO INJURIES WERE INVOLVED.
THE GENERATOR WAS CONFIRMED TO DISPLAY A LATCH ON CONDITION AS DESCRIBED BY THE CUSTOMER. THE CONDITION WAS CAUSED BY AN ISOLATED COMPONENT FAILURE OF AN OPTOISOLATER (SAME AS A OPTOCOUPLER BUT REFERRED TO AS AN OPTOISOLATER IN THIS CIRCUITRY). FOLLOWING REPLACEMENT OF THE COMPONENT, THE GENERATOR FUNCTIONED PROPERLY AND WITHIN ALL SPECIFICATIONS.  THE INFORMATION CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF VALLEYLAB THAT THE PRODUCT,WHICH IS THE SUBJECT OF THIS REPORT, IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR WAS CAUSALLY RELATED TO ANY DEATH OR INJURY.  CONFIDENTIAL TRADE SECRET INFORMATION SUBJECT TO 18-USC-1905 AND TO WHICH ALL CLAIMS OF PRIVELEGE AND CONFIDENTIALITY ARE ASSERTED IN BOTH STATUTORY AND COMMON LAW.
DISPOSABLE STAPLER MISFIRED WHILE STAPLING BRONCHUS. NO ADVERSE OUTCOME TO PT. EXPIRATION DATE: 9/2001.
REPORT OF ALLEGED "PRESSURE LIMIT CONTROL VALVE STUCK WHILE IN USE. DEVICE ALARMED AS INTENDED BY DESIGN, ALERTING THE CAREGIVER TO RESPOND. NO PT HARM".
LABELING-#1738. EVAL SUMMARY: PRESSURE LIMIT CONTROL ASEMBLY RETURNED TO MFR FOR ANALYSIS AND WAS FOUND TO STICK. VISUAL EXAM OF PRESSURE LIMIT CONTROL ASSEMBLY NOTED IT TO BE CONTAMINATED. MFR HAS ADVISED CUSTOMER TO FOLLOW RECOMMENDED INSTRUCTIONS FOR MORE FREQUENT FILTER CHANGES.
ONE ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S ILIAC ARTERY. UPON THE INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON BURST AT 1-2 ATMOSPHERES LEAVING THE STENT PARTIALLY EXPANDED. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION AND AN ADD'L BALLOON CATHETER WAS USED TO FULLY EXPAND THE STENT AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE BALL00N EXPANDABLE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP, STAPLES NOT ADVANCING. THERE WAS NO CONSEQUENCE TO THE PT.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT ADVANCE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE INFUSION PUMP APPEARED TO BE OPERATING, HOWEVER NO SOLUTION WAS BEING DELIVERED. NO ADDITIONAL SPECIFIC INFORMATION REGARDING THE OCCURENCE WAS ABLE TO BE RECEIVED. NO PT INJURY WAS REPORTED.
EVALUATION SUMMARY: FLOW ACCURACY TESTING WAS PERFORMED AT 125ML/HR AND AT 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION. THE MOST LIKELY CAUSE OF THE REPORTED OCCURRENCE WAS IMPROPER LOADING OF THE IV TUBING INTO THE  INFUSION PUMP. THE OPERATOR'S MANUAL INSTRUCTS TO, "ENSURE THAT THE TUBING IS THREADED STRAIGHT THROUGH THE PUMP MECHAMISM TUBING GUIDES AND SAFETY CALMP. ENSURE THAT THE TUBING IS TOUCHING THE PUMPING FINGERS BEFORE CLOSING THE PUMP DOOR". IT ALSO INSTRUCTS TO "CONFIRM FLOW BY CHECKING FOR DROPS IN THE I.V. SET DRIP CHAMBER." ONCE THE INFUSION IS STARTED.
PT FELL ASLEEP WHILE USING A HEATING PAD ON HER BACK WITHOUT ANY BARRIER BETWEEN THE PAD AND SKIN. HCP NOTED A 2 CM WATER BLISTER THEREAFTER. MD WAS NOTIFIED AND PT'S LIVE-IN CAREGIVER WILL BE GIVEN INSTRUCTIONS ON HOW TO USE THE HEATING PAD PROPERLY.
DEVICE SPONTANEOUSLY POWERS OFF DURING USE ON AC OR DC POWER. THE END USER IS NOT FAMILIAR WITH THE DISPLAY MESSAGES REGARDING THE POWER SOURCE FOR THE DEVICE.
DATE OF THIS REPORT: 11/14/96 EVENT CODE-2199-NA 1475-NOT LABELED. ALL SECTIONS ON THIS FORM COMPLETED BY MFR. MONITOR WAS RETURNED TO CO SERVICE CENTER FOR EVALUATION. A VISUAL INSPECTION SHOWED SIGNS OF PHYSICAL DAMAGE IN FORM OF DENTS AND PRY MARKS. MONITOR WAS CONNECTED TO CUSTOMER'S PRINTER MODULE AND POWERED UP ON AC POWER. DISPLAY SCREEN WAS NOT OPERATING PROPERLY AND ALPHANUMERICS WERE DISTORTED. THIS DID NOT AFFECT MONITOR OPERATION AS ALL OF PARAMETERS FUNCTIONED PROPERLY. A REVIEW OF ERROR AND TREND LOGS WAS PERFORMED WITH NO RELEVANT INFO OBTAINED. ACCORDING TO SCREEN DISPLAY BATTERY ICNS, BOTH BATTERIES WERE LOW ON ENERGY. UNIT WAS CONNECTED TO AN ARM SIMULATOR AND ALLOWED TO RUN FOR OVER 72 HRS ON AC POWER. UNIT OPERATED PROPERLY AND NO INCIDENT OF TURNING OFF, LOCKING UP, OR RESETTING WAS NOTED. THIS SHOULD HAVE COMPLETELY CHARGED BATTERIES, HOWEVER IT WAS NOTED THAT ONE BATTERY WAS STILL DEPLETED WHILE THE SECOND WAS ONLY PARTIALLY CHARGED. BATTERY POWER WAS THEN USED TO OPERATE MONITOR AND IN LESS THAN ONE HR BOTH BATTERIES WERE COMPLETELY DEPLETED AND MONITOR POWERED DOWN. A LOW BATTERY ALARM (AUDIO & VISUAL) WAS SEEN PRIOR TO THE UNIT POWERING DOWN. UNIT'S BATTERY CHARGING CIRCUITRY WAS OPERATING PROPERLY, INDICATING THAT NO MONITOR FAILURE LED TO BATTERIES INABILITY TO ACCEPT AND MAINTAIN A FULL CHARGE. ACCORDING TO INFO RECEIVED, CUSTOMER WAS NOT FAMILIAR WITH BATTERY OPERATION AND ASSOCIATED DISPLAY ICONS. NEXT THE MONITOR WAS SUBJECTED TO THERMAL STRESS AND VIBRATION WHILE OPERATING ON AC POWER IN AN ATTEMPT TO DUPLICATE THE REPORTED FAILURE. UNIT OPERATED PROPERLY WITH NO OCCURRENCE OF TURNING OFF. THE MONITOR WAS THEN DISASSEMBLED AND EXAMINED FOR ANY INDICATIONS OF A POSSIBLE CAUSE WITH NONE SEEN. THE CUSTOMER'S REPORT COULD NOT BE VERIFIED OR DUPLICATED. THOROUGH FUNCTIONAL TESTING WAS PERFORMED AND THE MONITOR OPERATED TO SPECIFICATION FOR THIS MODEL. AN ELECTRICAL TEST FAILURE FOR THE INVASIVE PRESSURE CIRCUITRY WAS SEEN, HOWEVER IT WAS NOT RELATED TO THE CUSTOMER'S REPORTED SYMPTOMS. NO PRODUCT CORRECTIVE ACTION IS PLANNED AS NO MONITOR RELATED ISSUES WERE FOUND TO HAVE CAUSED THE REPORT. CUSTOMER WILL BE SENT LITERATURE ON BATTERY OPERATION AND CHARGING. STATISTICAL PROCESS CONTROL (SPC) DATA WIL BE REVIEWED REGULARLY TO DETERMINE IF SIGNIFICANT TRENDS ARE IDENTIFIED RELATED TO THIS REPORT. IF SIGNIFICANT TRENDS ARE IDENTIFIED, A SEPARATE INVESTIGATION WILL BE INITIATED. CUSTOMER WAS SENT AN OPERATIONS MANUAL FOR BOTH MONITOR AND PRINTER MODULE WITH AREAS DETAILING BATTERY OPERATION HIGHLIGHTED. COPIES OF SECTION 3.4 FROM PLUS SERVICE MANUAL REGARDING "CARE OF STORAGE BATTIERIES" WAS ALSO SENT OUT WITH MONITOR.
BACK FRAME ASSEMBLY 20" RV PNTD. DEALER CLAIMS BACK FRAME IS BROKEN.
A PT SUFFERING FROM ATRIAL FIBRILLATION AND CONGESTIVE HEART FAILURE AND OTHER COMPLICATIONS, EXPERIENCED VALVE THROMBOSIS AND DEATH.
SECTION H6. METHOD CODE 86: DEVICE NOT RETURNED. DEVICE HISTORY RECORDS REVIEW PERFORMED. RESULTS CODE 100: DEVICE HISTORY RECORDS REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS FOR A SIZE 29 MITRAL CPHV AT THE TIME OF MANUFACUTRE AND RELEASE. CONCLUSION CODE 68: DEVICE NOT RETURNED. DEVICE HISTORY RECORDS REVIEW PERFORMED AND CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS FOR A SIZE 29 MITRAL CPHV AT THE TIME OF MANUFACTURE AND RELEASE. EVIDENCE SUGGESTS PT RELATED FACTORS CONTRIBUTED TO THE EVENT.
REPORT OF ALLEGED "PRESSURE LIMIT CONTROL VALVE STUCK WHILE IN USE. DEVICE ALARMED AS INTENDED BY DESIGN, ALERTING CAREGIVER TO RESPOND. NO PT HARM".
LABELING-#1738. EVAL SUMMARY: PRESSURE LIMIT CONTROL ASSEMBLY RETURNED TO MFR FOR ANALYSIS AND WAS FOUND TO STICK.
A ENDOVASCULAR STENT MOUNTED ON AN ULTRA-THIN BALLOON CATHETER WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S ILIAC ARTERY. UPON ATTEMPTED EXPANSION OF THE STENT, THE BALLOON BURST. GUIDEWIRE POSITIONING WAS MAINTAINED AND A SMALLER BALLOON WAS USED TO FULLY DEPLOY THE STENT AT THE TARGET LESION SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
THE P294 BALLOON EXPANDABLE STENT IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY.
THE PHYSICIAN WAS PERFORMING A PRECUT SPHINCTERECTOMY WITH A PRECUT SPHINCTEROTOME. IT WAS REPORTED THAT DURING THE PROCEDURE THE NEEDLE KNIFE NO LONGER EXTENDED FROM THE SHEATH. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE AND THE PHYSICIAN NOTICED THE NEEDLE KNIFE HAD DETACHED DURING DIATHERMY. THE NEEDLE KNIFE WAS VISUALIZED IN THE PT IMMEDIATELY AFTER THE INCIDENT OCCURRED AND WAS NOT RETRIEVED. THE PROCEDURE CONTINUED WITH ANOTHER MAKE OF PRODUCT. THE PT RETURNED TO THE HOSP THREE DAYS LATER FOR ROUTINE SCREENING AND NO ABNORMALITIES WERE NOTED.
THIS REPORT IS BASED ENTIRELY ON UNCONFIRMED INFO SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT IN IT IS INTENDED TO BE AN ADMISSION THAT ANY WILSON-COOK DEVICE (I) IS DEFECTIVE OR MALFUNCTIONED OR (II) CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. CO DOES NOT BELIEVE THAT THIS REPORTED INCIDENT IS LIKELY TO REOCCUR. THE SHEATH IS CHARRED AND MELTED AND THE CUTTING WIRE IS MELTED INTO A BALL. THE INSTRUCTIONS TO MOVE THE NEEDLE KNIFE WHILE APPLYING CURRENT TO AVOID EXCESSIVE FOCAL COAGULATION AND CHARRING. IT IS SUSPECTED THE USER DID NOT FOLLOW THE ENCLOSED INSTRUCTIONS ON THE RECOMMENDED METHOD FOR USE OF THIS DEVICE. NOTIFIED THE DISTRIBUTOR TO REVIEW INSTRUCTIONS FOR USE.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE INSTRUMENT EJECTED CLIPS PREMATURELY. THE HOSP HAS REPORTED THAT NO PT INJURY INJURY OCCURRED.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP, BALLOON BURST. THERE WAS NO CONSEQUENCE TO THE PT.
DEVICE RETURNED WITH NO LOT IDENTIFICATION. INSTRUMENT RETURNED WITH BALLOONS BURST AND PIECES TORN FREE. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE BALLOONS HAD BURST, MAKING THE INSTRUMENTS NON FUNCTIONAL. THE INSTRUMENTS WERE RECEIVED WITH THE BALLOONS BURST AND THE PIECES WHICH HAD TORN FREE FROM BOTH BALLOONS WERE RETURNED IN A SEPARATE BAG. THE BALLOONS WERE EXAMINED UNDER A 20X MICROSCOPE, AND THE POINTS OF PROPAGATION COULD NOT BE DETERMINED. NO CONCLUSIONS COULD BE REACHED AS TO WHY THE BALLOONS HAD BURST DURING SURGERY. NOTE: IT WAS ORIGINALLY REPORTED THAT 1 INSTRUMENT WAS BEING RETURNED, BUT 2 WERE RECEIVED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
THE COMPUTER TERMINAL (S/N 1609-0214) FOR THE MODEL 2180 "SMOKED" ACCORDING TO THE USER. NO PTS WERE INVOLVED AND THERE WERE NO INJURIES.
FREQUENCY ADDRESSED IN LABELING? NO. FREQUENCY GREATER THAN USUAL? NO. SEVERITY ADDRESSED IN LABELING? NO. SEVERITY GREATER THAN USUAL? NO THE 21X COMPUTER TERMINAL WAS RETURNED TO CO FOR EVALUATION. SEVERAL COMPONENTS IN THE POWER SUPPLY HAD OBVIOUSLY BURNED. WHEN THE TERMINAL WAS POWERED UP, THESE COMPONENTS AGAIN STARTED TO EMIT SMOKE. THIS TYPE OF FAILURE IS NOT UNUSUAL FOR A DEVICE OF THIS AGE (10 YRS) AND THIS TECHNOLOGY. THIS PRODUCT HAS NOT BEEN MFR SINCE 1989.
CUSTOMER COMPLAINS THE MAIN FRAME HAS CRACKED/BROKE ON THE SIDE OF THE COT BETWEEN THE DROP FRAME HINGE AND SIDEARM MOUNT CASTING. NO INJURIES REPORTED.
COT WILL NOT BE MADE AVAILABLE FOR EVALUATION BY THE MFR.
REAS S/F DAB PNTD L QZ. DEALER CLAIMS FRAME BROKE.
HIGH STRESS FACTOR AT HOLE LOCATION. THIS REPORT OR OTHER INFO SUBMITTED BY QUCKIE DESIGNS, NC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC. ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
DURING ROUTINE TESTS AT INSTALLATION OF UNIT, CO'S SERVICE REP NOTED OUTPUT OF VAPORIZER WAS NOT WITHIN SPEC. CO'S INVESTIGATION INTO THE REPORTED EVENT IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
DURING A COELIO GYNECOLOGICAL PROCEDURE, THE CLIPS DID NOT LOAD PROPERLY. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
ADDITIONAL INFO WAS RECEIVED FROM A AFFILIATE ON 9/19/96. INFO RECEIVED INDICATED THAT THE STENT EMBOLIZED TO THE PATIENT'S PERIPHERAL VASCULATURE. NO ATTEMPTS WERE MADE TO RETRIEVE THE STENT. THE PATIENT EXPERIENCED NO CLINICAL SEQUEALA RELATIVE TO THIS EVENT. INFO TO DATE ON SIMILAR EVENTS WOULD REASONABLY SUGGEST THAT WERE THIS MALFUNCTION TO RECUR IT WOULD NOT BE LIKELY TO RESULT IN A SERIOUS INJURY DEATH.
THE PHYSICIAN WAS UNSUCCESSFUL IN THE ATTEMPT TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM THROUGH TORTUOUS ANATOMY TO THE TARGET LESION SITE IN THE PATIENT'S LEFT ANTERIOR DESCANDING ARTERY. UPON THE WITHDRAWAL ATTEMPT, THE STENT AMBOLIZED FROM THE DELIVERY BALLOON TO AN UNK LOCATION IN THE PATIENT'S BODY. NO FURTHER ACTIONS WERE PERFORMED AND THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
IV R.N. ATTEMPTED TO ACCESS PORT BUT WAS UNABLE TO GET A BLOOD RETURN AND COULD NOT INJECT FLUID. TRIED LONGER NEEDLE WITH SAME RESULTS. PATIENT WAS SENT TO RADIOLOGY. X-RAY APPEARS TO SHOW A "KINK" AT ABOUT 3CM DISTAL TO PORT. INJECTION OF OMNIPAQUE INTO PORTAL RESERVOIR UNDER FLUOROSCOPY. A LEAK OF THE CONTRAST MEDIUM FROM THE CATHETER, APPROXIMATELY 6CM DISTAL TO THE RESERVOIR WAS DEMONSTRATED. THERE WAS SOME OPACIFICATION OF THE REMAINING PORTION DISTAL TO THE LEAK, BUT NO SIGNIFICANT FLOW OF CONTRAST MEDIUM IN THE SUPERIOR VENA CAVA WAS DETECTED.SYSTEM TO BE EXPLANTED AT SOME POINT IN THE FUTURE.
BASELINE REPORT FOR THIS DEVICE FAMILY SUBMITTED WITH REPORT 2183502-1996-00001 DATED 8/27/96. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.H3-DEVICE REMAINS IMPLANTED, THEREFORE NOT AVAILABLE FOR EVALUATION PURPOSES.ENTIRE FORM COMPLETED BY MANUFACTURER.
AB) THE INSTS. WERE RECEIVED WITH SMALL HOLES/RIPS IN THE BALLOON. A) A JAGGED 'S' SHAPED RIP WAS FOUND THAT 270 DEGREES FROM THE STOPCOCK POSITION IN THE PROXIMAL PORTION WHICH WAS 1/4" IN HEIGHT. THERE WAS AN ABRASION MARK WHICH WAS PERPINDICULAR TO THE 'S' SHAPED RIP AND WAS APPROX. 1/8" IN LENGTH. THERE WERE 2 ID IN THE PROXIMAL PORTION LOCATED AT THE 'S' RIP WHICH WERE 1/8" IN LENGTH AND WERE 3/16" BELOW THE 'S; SHAPED RIP. B) THE INST. WAS RECEIVED WITH PERMANENT BLUE INK MARKS CIRCULED ONTO THE BALLOON, LOCATED IN THE PROXIMAL PORTION. INSIDE THE MARKED CIRCLES WERE 2 SMALL CUTS. ABRASION MARKS WERE OBSERVED IN THE BALLOON. AB) THE BALLOONS WERE EXAMINED UNDER A 20X MICROSCOPE AND NO CONCLUSION COULD BE REACHED AS TO HOW THE BALLOONS HAD BECOME DAMAGED. AB) EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
DURING SERVICE OF PRODUCT A POTENTIAL NO LOW PRESSURE ALARM CONDITION WAS FOUND DUE TO TRANSDUCER BEING OUT OF SPECIFICATION REPLACED TRANSDUCER.
THE INFUSION PUMP RECEIVED AT THE SERVICE FACILITY WITH A VAGUE REPORT THAT IT WAS USED ON A PT AND THE PUMP HAD AN "INACCURATE FLOW RATE". NO PT INJURY WAS REPROTED. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED.
SECTION F COMPLETED BY MANUFACTURER. EVALUATION SUMMARY. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION.
X-TUBE ASSEMBLY 18" X 18". DEALER CLAIMS X-TUBE BROKE AT THE WELD.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
CUSTOMER COMPLAINS OF INTERMITTENT CONDITION OF UNDERCARRIAGE NOT UNFOLDING.
HOSP REPORTS, WHILE SUTURING, NEEDLE BROKE. PT'S UTERUS WAS OPENED TO RETRIEVE THE NEEDLE. X-RAY WAS USED TO LOCATE THE NEEDLE.
A1,2,3,4; B3,6,7;D10: INFO NOT PROVIDED BY AFFILIATE. D5,6;H4,6: INNFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
THE INFUSION PUMP WAS RECEIVED AT THE SERVICE FACILITY WITH A VAGUE REPORT THAT THE PUMP WAS BEING USED ON A PT AND THE PUMP HAD AN "INACCURATE FLOW RATE". NO PT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS ABLE TO BE RECEIVED.
X-TUBE ASSEMBLY 18" X 16". DEALER CLAIMS X-TUBE BROKE AT THE RIGHT SIDE ON THE TOP.
EVAL NOT YET BEGUN. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
WHILE ON A FIELD SERVICE CALL FOR ANOTHER PRODUCT, A DEALER RECEIVED A COMPLAINT FROM A DENTIST SAYING "THE % OF N2O WAS OFF". ANALGESIA GAS MACHINE (FLOWMETER) WAS RETURNED FOR REPAIR AND WAS RECEIVED ON 10/9/96. UPON EVAL IT WAS DETERMINED THAT THE FLOWMETER COULD FLOW N2O WITHOUT O2. THIS INSTRUMENT IS DESIGNED TO DELIVER MIXED O2 AND N2O TO A DENTAL PT. WHEN O2 FLOW OR PRESSURE IS NOT PRESENT, INSTRUMENT HAS A FEATURE WHICH STOPS THE FLOW OF N2O. THIS FEATURE, THEREFORE, HAD MALFUNCTIONED. CO FOLLOW-UP REPORT OF THE DENTIST CONTACT STATES "THERE WAS NO PT INVOLVED, HE HAD NOTICED THAT THE % WERE WAY OFF AND THEN USED THE METER AS A STANDARD METER (BY THE BALLFLOATS)". THEREFORE, AT NO TIME DID A PT RECEIVE 100% N2O FROM THIS DEVICE AS A RESULT OF THIS MALFUNCTION. CO HAS PREVIOUSLY SUBMITTED MDR'S WHEN THE FAILSAFE HAS MALFUNCTIONED. UNDER THE CURRENT REGULATIONS, CO HAS EXEMPTION WITH THE FDA ON 11/6/96.
QUALITY DEPT, AS A MATTER OF POLICY, REVIEWS UNITS RETURNED FOR REPAIR, AND ALSO INVESTIGATES COMPLAINTS. SUBJECT COMPLAINT CONCERNS A MALFUNCTION CATEGORY PREVIOUSLY DEFINED AS REQUIRING THE FILING OF AN MDR. CO'S REGULATORY AFFAIRS REVIEW GROUP HAS REVIEWED ALL INFO THAT IS REASONABLY AVAILABLE IN A TIMELY MANNER AND DETERMINED NOT TO SUBMIT AN MDR. UNDER THE INSTRUCTION THE OFFICE OF SURVEILLANCE AND BIOMETRICS, CO HAS DECIDED TO SUBMIT THIS MDR DETERMINATION TO THE FDA FOR REVIEW. REGULATORY AFFAIRS REVIEW GROUP'S DETERMINATION IS BASED ON A REVIEW THAT A MALFUNCTION WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. AS PROVIDED IN 21CFR803.16, THIS REPORT OR OTHER INFO RECORDED BY CO UNDER 21 CFR 803, DOES NOT NECESSARILY REFLECT A CONCLUSION BY CO THAT THE REPORT OR INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, OR CO, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT. THIS ANALGESIA GAS MACHINE (FLOWMETER) WAS ORIGINALLY SHIPPED ON 12/29/95. DEVICE HISTORY RECORD FOR THIS UNIT SHOWS THAT IT HAS NEVER BEEN RETURNED FOR SERVICE/REPAIR SINCE IT'S ORIGINAL SHIPMENT IN 1995. UPON RETURN TO CO THE FLOWMETER WAS EVALUATED BY QC. IN THIS EVAL THE UNIT FLOWED N2O WITHOUT O2 COULD BE REPRODUCED DURING THE SPECIFIC FAILSAFE SAFETY CHECK THAT IS PART OF THE EVAL PROCESS. UNIT WAS FURTHER EVALUATED BY ENGINEERING ON 10/10/96. TEST PROCEDURE TP-102 PRODUCED THE REPORTED COMPLAINT OF N2O WITHOUT O2 EVEN USING THE EXTENDED DYNAMIC TEST AT CONSIDERED TO BE A SEVERE TEST OF POPPET PERFORMANCE. IT IS ONE OF THE TESTS PERFORMED ON 100% OF THE NEW PRODUCTION UNITS. A COMPLETE DISASSEMBLY OF THE UNIT WAS THEN DONE, FOLLOWING THE SAME PROCEDURE THAT HAS BEEN DEVELOPED OVER THE COURSE OF EVALS OF OTHER FAILSAFE MALFUNCTIONS. THERE WAS NO INDICATION OF VISIBLE DAMAGE TO THE UNIT. BASED UPON THE OBSERVATIONS MADE DURING THIS EXAM, CAUSE OF MALFUNCTION WAS DETERMINED TO FALL UNDER THE LACK OF SUFFICIENT LUBRICATION CATEGORY. UNIT'S FAILSAFE BLOCK WAS REPAIRED AS NEEDED, RP-102 WAS PERFORMED (THE PROCEDURE FOR RECONDITIONING MXR FLOWMETERS), THEN IT WAS TESTED IN THE USUAL MANNER AND RETURNED TO THE CUSTOMER. CO RECOMMENDS THAT BETWEEN SERVICING INTERVALS TO SAFEGUARD AGAINST POTENTIAL MALFUNCTIONS BY PERFORMING THE FAILSAFE CHECK BEFORE EACH AND EVERY USE OF THE UNIT. CO CONCLUDES THAT PREVIOUS ACTIONS TO MINIMIZE FAILSAFE MALFUNCTIONS ARE STILL VALID AND THIS MDR EVAL DOES NOT LEAD TO ANY DIFFERENT CONCLUSIONS OR NEW ACTIONS. NO FURTHER ACTIONS ARE REQUIRED. CO BELIEVES THAT UNDER SECTION 803.20(C), THIS CATEGORY OF MALFUNCTION IS EXEMPT FROM FUTURE MDR REPORTING AND HAS SUBMITTED A MDR EXEMPTION REPORT TO THE FDA ON 11/6/96. CO WILL SUBMIT SIMILAR MDRS UNTIL IT IS NOTIFIED OTHERWISE BY THE FDA.
INVESTIGATION IS IN PROGESS. PRODUCT CODE AND LOT NUMBER ARE UNK, THEREFORE IT IS NOT POSSIBLE TO DETERMINE AT WHICH LOCATION THE DEVICE WAS MFG.PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.
REPORT OF ALLEGED "LOW PRESSURE LED FLASHES WITH NO AUDIBLE ALARM. INTERMITTENT SETTING ERROR ALARM".
NOTE: THREE ATTEMPTS WERE MADE TO OBTAIN REQUIRED INFO. LABELING-#1738. EVAL SUMMARY: TESTING BY MFR FOUND DEVICE FULL FUNCTIONAL.
FROM THE FACILITY 8/21/96 QUALITY IMPROVEMENT REPORT: "WHEN PACING WAS SELECTED ON THIS DEFIBRILLATOR, IT FAILED. THE DEFIB WAS BEING SET UP FOR AN ASYSTOLE PT WHO HAD ARRIAVED (IN) THE EMERGENCY ROOM. THE UNIT WAS ATTACHED TO THE PT VIA ANOTHER CO'S CABLES, AND THE PACING OPTION WAS SELECTED. IT FAILED IMMEDIATELY AND THE NURSE SETTING UP THE DEFIBRILLATOR IMMEDIATELY CHANGED THE DEFIBRILLATOR WITH ANOTHER M1722A, AND THE PACING FUNCTIONED PROPERLY."
INSPECTION OF THE DEFIBRILLATOR AT THE MEDICAL CENTER BY FACTORY PERSONNEL INDICATED THAT THE PACER BOARD OUTPUT WIRE WAS NOT COMPLETELY CONNECTED. ONCE THIS WAS CONNECTED, THE PACER FUNCTIONED PROPERLY. A RECOMMENDATION WAS MADE TO MEDICAL CENTER TO INCORPORATE THE PACER FUNCTIONAL TEST (AS DESCRIBED IN THE M1722A/B USER'S GUIDE) INTO THEIR ROUTINE DAILY DEFIBRILLATOR CHECKS. THE UNIT IS BACK IN SERVICE.
THE INFUSION PUMP WAS RECEIVED AT THE SERVICE FACILITY WITH A VAGUE REPORT  THAT IT WAS USED ON A PT AND THE DEVICE WAS "INACCURATE". NO ADDITIONAL SPECIFIC INFORMATION WAS ABLE TO BE RECEIVED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MANUFACTURER. EVALUATION SUMMARY. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION.
RESPIRATORY THERAPIST LAVAGED PT'S TRACHEOSTOMY TUBE WITH 20CC AMPULE OF SOLUTION THERAPIST THOUGHT WAS USING SALINE, BUT IT WAS A SOAP SOLUTION. PHYSICIAN WAS INFORMED AND PT LAVAGED AND SUCTIONED NUMEROUS TIMES IMMEDIATELY AFTERWARD TO CLEAR AIRWAY. ONLY ABOUT 5CC OF SOLUTION HAD BEEN USED. THE SOAP SOLUTION, IS IN A CLEAR VIAL MARKED "NOT FOR INJECTION", BUT IS NOT IDENTIFIED AS A SOAP SOLUTION.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE INSTRUMENT EJECTED CLIPS PREMATURELY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE INSTRUMENT WAS RECEIVED WITH EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY. THE INSTRUMENT WAS CYCLED AND FIRED THE REMAINING 9 STAPLES INTERMITTENTLY. IT WAS CONCLUDED THAT THE EXCESSIVE DRIED BODY FLUIDS CAUSED THE STAPLES TO FEED INTERMITTENTLY. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY MAY HAVE CAUSED THE REPORTED "STAPLES NOT ADVANCING" DURING SURGERY. THE INSTRUMENT WAS RECEIVEED WITH DRIED BODY DLUIDS IN THE CARTRIDGE ASSEMBLY AND WAS CYCLED AND FIRED THE REMAINING 9 STAPLES INTERMITTENTLY. IT WAS CONCLUDED THAT THE EXCESSIVE DRIED BODY FLUIDS HAD CAUSED THE STAPLES TO FEED INTERMITTENTLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSELMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
CO CAN INFER FROM THE SECOND INCIDENT THAT SIMILAR CONDITIONS WERE APPLICABLE TO THE FIRST INCIDENT. CONTRAST MEDIA IS INJECTED BY A HIGH PRESSURE INJECTOR, AND THIS TUBING IS NOT RECOMMENDED FOR HIGH PRESSURE INJECTION. RUPTURE OF THE TUBING CAN BE ANTICIPATED IF USED FOR SUCH PURPOSES. HIGH PRESSURE INJECTION TUBING IS AVAILABLE FOR INJECTION OF CONTRAST MEDIA.
ON 8/16/96 A REPORT WAS RECEIVED BY THE SPONSOR OF AN INCIDENT WHERE A BOX CONTAINED A DIFFERENT PRODUCT THAN THE OUTER LABEL INDICATED (THE BOX WAS LABELED FOR A STD+/LG 10.0MM ROTATING BRIDGING BEARING WHILE THE BOX ACTUALLY CONTAINED A STD 12.5MM DEEP DISH ROTATING BEARING). THE DEVICE WAS IMPLANTED ON 8/16/96 WITHOUT INCIDENT (ALTHOUGH THE SURGERY WAS PLANNED FOR THE USE OF A STD+/LG 10.0MM BRIDGING BEARING, THE DEEP DISH 12.5MM THICKNESS BEARING WAS FOUND TO BE SATISFACTORY FOR USE IN THIS CASE). THE MISLABELING INCIDENT WAS INVESTIGATED BY CO'S QA DEPT AND IT REVEALED THAT TWO PRODUCTION ORDERS OF LCS BEARINGS WERE BEING PACKAGED AT THE SAME TIME AND THE LABELS WERE INADVERTENTLY MIXED. ALL PRODUCTS, WITH THE EXCEPTION OF THE SUBJECT DEVICE, FROM BOTH PART NUMBERS 1278-51-025 AND 1278-57-025 WERE IN CO INVENTORY AND HAVE BEEN RECONCILED AND THE PROBLEM CORRECTED. BASED ON THE FACT THAT ALL MIXED UP PARTS WERE RETRIEVED FROM INVENTORY, AND THAT THE ONE IMPLANTED DEVICE DID NOT INCUR ANY COMPLICATIONS. CO FINDS THIS NOTIFICATION REPORT TO BE SUFFICIENT. CO STATES THAT THEY HAVE CORRECTED THE PROBLEM.
AN ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION SITE IN THE PT'S ILIAC ARTERY. UPON THE INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON BURST LEAVING THE STENT PARTIALLY EXPANDED AT THE TARGET LESION SITE. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PT WITHOUT COMPLICATION. ATTEMPTS TO USE AN ADD'L BALLOON CATHETER TO FULLY EXPAND THE STENT WERE UNSECCESSFUL. USING THE GUIDEWIRE, THE STENT WAS WITHDRAWN INTO THE INTRODUCER SHEATH AND WAS SUCCESSFULLY WITHDRAWN FROM THE PT'S VASCULAR ACCESS SITE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
A P3008 BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM IS INDICATED FOR USE IN BILIARY PROCEDURES ONLY.
CASTER HINGE L AND R RV. DEALER CLAIMS CASTERS ARE STRIPPED.
INSUFFICIENT THREAD ENGAGEMENT. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC. UNDER 21 CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC. OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTE TO THE REPORTABLE EVENT.
THE HOSPITAL REPORTED HAVING FOUR OCCURRENCES OF INFILTRATIONS IN THE LAST FEW WEEKS WHILE USING THE PUMPS. THREE OF THESE OCCURRENCES WERE DESCRIBED AS SIGNIFICANT, HOWEVER NO SPECIFIC INFORMATION WAS RECEIVED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE HOSPITAL USED ANOTHER MFRS CONTROLLERS PREVIOUSLY.
SECTION F COMPLETED BY THE MFR. THE SPECIFIC PUMPS WERE NOT IDENTIFIED BY THE REPORTING HOSPITAL. THE PUMP DOES NOT HAVE INFILTRATION DETECTION CAPABILITIES. INFILTRATION IS A COMPLICATION OF IV THERAPY. THE HEALTHCARE PROFESSIONAL HAS THE RESPONSIBILITY FOR FREQUENT INSPECTION OF THE IV SITE FOR SIGNS OF AN INFILTRATION.
THE INFUSION PUMP WAS RECEIVED AT THE SERVICE FACILITY WITH A VAGUE REPORT THAT IT WAS USED ON A PT AND THE PUMP HAD AN "INACCURATE FLOW RATE". NO PT INJURY RESUTLED. NO ADDITIONAL INFORMATION WAS ABLE TO BE RECEIVED.
SECTION F COMPLETED BY THE MANUFACTURER. EVALUATION SUMMARY. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE ACCURACY RESULTS WERE WITHIN SPECIFICATION.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED AS THE "PROSTHESIS GRADUALLY QUIT INFLATING. EVENTUALLY THE DEVICE BECAME NON-FUNCTIONAL." AS REPORTED TO CO, THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
EVALUATION AND DECONTAMINATION IS PENDING RECEIPT OF THE DEVICE. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE. AN EVALUATION WILL BE FORWARDED UPON COMPLETION.
WHILE PT WAS UNDER MAC ANESTHESIA FOR A SUPRACLAVICULAR LYMPH NODE BIOPSY, PT SUSTAINED A FLASH BURN TO HER LEFT EAR CARTILAGE & HAIRLINE. DRAPES WERE VENTED & ONLY IN CONTACT AT HAIR LINE ON (L) SIDE. PT'S HAIR WAS CONTAINED UNDER OR CAP. PT WAS BREATHING SPONTANEOUSLY WITH O2 FACE MASK @ IOL.CRNA NOTED 5-6" FLAMES @ THE PT'S HAIRLINE AFTER A BOVIE "POP" WAS HEARD FROM INSIDE THE WOUND. INTERIOR OF THE WOUND WAS CHARRED. BOVIE GROUND PAD WAS INTACT.
NO LOT NUMBER WAS REPORTED SO DEVICE HISTORY COULD NOT BE SEARCHED. THE PRIMARY MATERIAL CONSTRUCTION IN THIS DRAPE IS NONWOVEN. CO CONFORMS TO THE APPLICABLE FEDERAL STANDARD FOR CLOTHING TEXTILES. NO SPECIMEN OF DEVICE HAS EVER FAILED TO FALL INTO THE "NORMAL FLAMMABILITY" CLASSIFICATION. CO LABELING STATES - "CAUTION: THE CONTENTS OF THIS PACKAGE, AS WITH ANY LINEN OR DISPOSABLE DRAPE AND GOWN MATERIAL, MAY BURN IF EXPOSED TO A FLAME OR EXTREMELY HOT OBJECT. AVOID CONTACT WITH AN OPEN FLAME OR HIGH INTENSITY HEAT SOURCES. DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHESIA".
DURING A LAPAROSCOPIC CHOLECYSTOMY PROCEDURE. THE CLIPS DID NOT ADVANCE. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP, DOES NOT FIRE/MISFIRE. THERE WAS NO CONSEQUENCE TO THE PT.
X-TUBE ASSEMBLY 17" X 16". DEALER CLAIMS X-TUBE BROKE.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC OR THE FDA THAT THE DEVICE. QUICKIE DESIGNS, INC, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
THE IAB WAS INSERTED INTO THE PT IN THE CATH LAB. AFTER IABP FOR ABOUT 36 HOURS, THE IAB LEAKED. A SECOND IAB WAS INSERTED LATER WHEN THE PT WENT TO THE O.R.
DEVICE LABEL CODE FOR F10. POSITION 1 AND 2: 1738, AND POSITION 3: 1701. THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION INSPITE OF NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR THE RETURN OF THE PRODUCT.
IT WAS REPORTED THAT THE INFUSION PUMP APPEARED TO BE OPERATING AT A DISPLAYED RATE OF 100 ML/HR, HOWEVER NO FLUID WAS BEING ADMINISTERED. IT IS NOT KNOWN HOW LONG THE PUMP WAS OPERATING BEFORE IT WAS NOTED. THE HOSPITAL BIOMED. EVALUATED THE PUMP AND FOUND EXCESS IV TUBING BEING LOCATED IN THE PUMP HEAD AREA WHICH CAUSED THE TUBING TO BE RESTRICTED WHEN THE PUMP DOOR WAS CLOSED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. THE MOST LIKELY CAUSE OF THE REPORTED OCCURRENCE WAS IMPROPER LOADING OF THE IV TUBING THROUGH THE INFUSION PUMP.
THE CUSTOMER REPORTED THAT THE CONNECTOR WAS SILICONE RECESSED OR MISSING. THE CUSTOMER REPORTED NO PATIENT INJURY OCCURRED; HOWEVER, A SEVERE AMOUNT OF BLOOD WAS LOST. THE CUSTOMER WAS UNABLE TO DETERMINE THE EXACT AMOUNT OF BLOOD LOSS. THE PATIENT HAS AN IMPLANTED HUBER PORT. THE CONNECTOR WAS IN PLACE FOR 24 HOURS. THE PATIENT RECEIVED A RAPID INFUSION OF KYTLEDECADRON WITH ANOTHER CO.'S INFUSION TUBING, CATALOG #4293. THE RAPID INFUSION WAS PRECEDED WITH A SALINE FLUSH WITH A SYRINGE. THE PATIENT WENT TO HOME HEALTH CARE AGENCY. THE PATIENT'S CATHETER WAS THEN ATTACHED TO A PUMP SET FOR THE PATIENT TO RECEIVE TPN. THE PATIENT'S DAUGHTER CONNECTED THE PUMP TO THE CATHETER UNDER THE SUPERVISION OF THE HOME HEALTH CARE NURSE AND NO ANOMALIES WERE NOTICED. THE CUSTOMER STATED THAT IN A MATTER OF SECONDS, BLOOD WAS ALL OVER THE PATIENT'S CLOTHING AND CHAIR.
THIS REPORT IS BEING SUBMITTED ON THE BASIS THAT THE HEALTHCARE WORKER STATED A SEVERE AMOUNT OF BLOOD LOSS OCCURRED. THE CONNECTOR THAT WAS RETURNED FOR EVALUATION WAS DISASSEMBLED AND VISUALLY INSPECTED. IT WAS OBSERVED THAT THE SPIKE WAS BENT IN A MANNER CONSISTENT AS SEEN WHEN A C1000 IS ACCESSED WITH AN INCOMPATIBLE LUER. THE LABELLING PROVIDES A LISTING OF DEVICES WHICH ARE COMPATIBLE WITH THE DEVICE.
THE UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED, THE CAUSE OF WHICH WAS THE ROTARY VALVE. CO HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE TEC 6 VAPORIZER. AS A RESULT, THE FREQUENCY OF OCCURENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED U.S. BASE IN FISCAL YEAR 1996 FROM 0.4% IN 1994. CO WILL CONTINUE TO MONITOR THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER AND/OR PROCESS MODIFICATIONS.
THE INFUSION PUMP WAS RECEIVED AT CO'S SERVICE WITH NOTE INDICATING IT WAS INVOLVED IN A NONDELIVERY. A NOTE WITH THE PUMP STATED "IV WAS HUNG. THE PUMP SHOWED IT WAS INFUSING-BUT NO FLUID LEFT THE BAG. FIVE HOURS AFTER INFUSION, BAG WAS STILL FULL BUT PUMP SAID IT INFUSED 600 ML/HR." NO ADD'L INFO WAS ABLE TO BE RECEIVED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. EVAL SUMMARY: FLOW ACCURACY WAS PREFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION. THE MOST LIKELY CAUSE OF THE REPORTED OCCURRENCE WAS IMPROPER LOADING OF THE IV TUBING BY THE USER. THE OPERATOR'S MANUAL INSTRUCTS TO "ENSURE THE TUBING IS LOADED STRAIGHT THROUGH THE PUMP MECHANISM TUBING GUIDES AND SAFETY CLAMP." AND TO "CONFIRM FLOW BY CHECKING FOR DROPS IN THE I.V. SET DRIP CHAMBER." WHEN THE INFUSION IS STARTED.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT ADVANCE. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE ABOVE DESCRIBED DEVICE WAS BEING UTILIZED ON A PT FOR A CHOLECYSTECTOMY PROCEDURE. DURING USE, THE MARKERS WERE COMING OFF THE DEVICE AND WERE IN THE PT. THEY WERE ABLE TO RETRIEVE THE MARKER FRAGMENTS FROM THE PT.
A1. INFO NOT PROVIDED BY REPORTING INSTITUTION. A2. INFO NOT PROVIDED BY REPORTING INSTITUTION. A3. INFO NOTPROVIDED BY REPORTED INSTITUTION. A4. INFO NOT PROVIDED BY REPORTED INSTITUTION. H6. AN EXAMINATION FOUND BOTH THE RETURNED USED AND UNUSED DEVICES TO HAVE BEEN MFG ACCORDING TO SPECIFICATIONS. HOWEVER, A KINK, APPROX 1.5CM FROM THE DISTAL TIP, WAS NOTED ON THE RETURNED USED DEVICE. ALSO NOTED WERE GOUGE MARKS IN AT THE DISTAL END, POSSIBLY CREATED BY A GRASPING DEVICE. THE APPEARANCE OF THE DEVICE SUGGESTS THE MARKERS HAVE BEEN SCRAPPED OFF AS OPPOSED TO FLAKING OFF.
PT ADMITTED 6/9/96 WITH 3 VESSEL CORONARY DISEASE. HAD CABG ON 6/12/96. HAD MULTIPLE VENTRIC. FIB. ARRESTS ON 6/16 AND 6/17. ON 6/17 REQUIRED 6-8 DEFIBS AT 360 JOULES. SUSTAINED 2 DEGREE BURNS TO LEFT FOREARM AND MINOR BURN TO RIGHT RIB AREA. ARE REQUIRED GRAFTING. STAFF INVOLVED BELIEVES 25LBS OF PRESSURE WAS NOT MAINTAINED ON PADDLES CAUSING "ARCING" AND FIRE.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT ADVANCE. THE SURGEON APPLIED ANOTHER  INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A THORACOSCOPY. IT WAS REPORTED THE EZ45G INITIAL CARTRIDGE FELL OUT OF THE DEVICE TWICE INTO THE THORACIC CAVITY. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4;B6,7;D10: INFO UNAVAILABLE. 10/17/96 1110 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/18/96 NNCL SENT. D5; H4: INFO UNAVAILABLE.
REPORT OF ALLEGED" NO APNEA ALARM DURING SIMULATOR TESTING".
LABELING-#1738. EVAL SUMMARY: TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL.
COMPLAINANT ALLEGED THAT STAFF MEMBERS WERE TREATING A PT (AGE AND GENDER UNKNOWN) WHO WAS IN V-TACH. THE STAFF SET THE UNIT IN SYNCH MODE AND CHARGED THE UNIT TO 200J USING THE UNIT'S PADDLES. THE UNIT DID NOT DISCHARGE. THE STAFF TURNED THE UNIT OFF AND THEN ON AGAIN. THE UNIT WAS SET TO SYNCH MODE AGAIN AND CHARGED TO 360J. THE UNIT DID NOT DISCHARGE. THE PT'S RHYTHM WENT INTO ATRIAL FIBRILLATION. THE STAFF CHARGED THE UNIT TO 360J AND DEFIBRILLATED THE PT. THE UNIT FUNCTIONED PROPERLY FOR THE DURATION OF THE TREATMENT AND THE PT'S RHYTHM WAS CONVERTED. THERE WAS NO ADVERSE EFFECT ON THE PT. THE FACILITY'S BIOMED ENGINEERING DEPT EVALUATED THE UNIT AND FOUND IT TO BE FUNCTIONING PROPERLY. THE FACILITY HAS INDICATED THE ALLEGED MALFUNCTION MAY BE ATTRIBUTABLE TO USER EROR. THE UNIT WAS RETURNED TO SVC.
THE IAB LEAKED. BLOOD  WAS NOTED IN THE TUBING AND THE IAB WAS REMOVED. A SECOND WAS INSERTED INTO THE PT.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PORDUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHITBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. THE PENETRATION  WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. DEVICE LABEL CODE: 1738.
X-TUBE ASSM 17" X 16". DEALER CLAIMS X-TUBE BROKE, LEFT SIDE IN THE CENTER, AND RIGHT SIDE ON THE BOTTOM.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC OR THE FDA THAT THE DEVICE, QUICKIE DESIGN, INC ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
AREA WHERE THE POWER CORD ADAPTER ATTACHES TO THE PUMP BECAME BURNED AND FILLED THE PT'S ROOM WITH SMOKE. THE PT WAS REMOVED FROM THE ROOM AND NO INJURY OCCURRED. THE INFUSION PUMP WAS REMOVED FROM PT USE.
SECTION F COMPLETED BY THE MFR. EVALUATION SUMMARY: PUMP WAS RECEIVED AND EVALUATED BY CO. THE ELECTRICAL PLUG WAS BLACKENED WHERE IT ATTACHES TO THE PUMP. THE LINE OR NEUTRAL PRONG WAS MELTED INTO THE PLUG OF THE CORD. THE RECEPTACLE PRONG WAS BROKEN OFF AND MELTED INTO THE PLUG. THERE WERE VISIBLE SIGNS OF DRIED SOLUTION, BOTH ORANGE AND GREEN, ON THE PUMP SURFACE AND INTERIOR FRAME OF THE PUMP. THE CASE MATERIALS ARE UL LISTED AND WILL NOT SUPPORT A FLAME BY THEMSELVES.
ALTHOUGH THIS COMPLAINT HAS NOT BEEN REPORTED, CO IS CONTACTING YOU TO LET YOU KNOW IN CASE FURTHER INFORMATION IS RECEIVED THROUGH OTHER CHANNELS. THE COMPLAINT WAS MADE TO CO PER PRODUCT AS A MEDICAL DEVICE. HOWEVER, THE PRODUCT IS NOT A MEDICAL DEVICE BUT A COSMETIC PRODUCT. THE PRODUCT IS MARKED IN ACCORDANCE WITH PART 700 21 CFR AND LABLED TO CONFORM TO PART 701 OF 21 CFR. PRODUCT IS A SKIN CARE PREPARATION INTENDED TO CLEANSE THE SKIN ESPECIALLY IN AREAS AROUND WOUNDS. NO ADVERSE EVENT OCCURRED. THE REPORT WAS FILED BECAUSE RPTR FELT THERE WAS A PRODUCT IMPROVEMENT OPPORTUNITY TO PERHAPS INCLUDE ADD'L INFO ON THE LABEL TO IDENTIFY IT AS A "SOAP". LABELING FOR THIS PRODUCT IS CURRENTLY UNDER REVIEW. NO FURTHER FOLLOW-OF THIS REPORT IS REQUIRED.
THE FOLLOWING WAS REPORTED ON 9/18/96: THE THERAPIST WAS CALLED STAT TO THE BEDSIDE BECAUSE BLOOD WAS NOTED IN THE HELIUM TUBING. IABP WAS IMMEDIATELY STOPPED AND THE PATIENT WAS PLACED IN THE MODIFIED TRENDELANBURG POSITION. THE CARDIOLOGIST WAS NOTIFIED. ANOTHER IAB WAS INSERTED. IT WAS ALSO REPORTED THAT THE PATIENT REMAINED IN THE OPEN HEART UNIT IN SERIOUS CONDITION. IABP WAS DISCONTINUED 3 DAYS POST-OP.
X-TUBE ASSM. 19" X 18" DEALER CLAIMS X-TUBE BROKE AT THE PIVOT BOLT.
HIGH STRESS FACTOR AT CENTER AND ENDS OF X-TUBE. THIS REPORT OR OTHER INFO SUBMITTED BY QUICKIE DESIGNS, INC UNDER 21CFR PART 803, AND ANY RELEASE BY THE FDA OF THAT REPORT OR INFO, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY QUICKIE DESIGNS, INC OR THE FDA THAT THE DEVICE, QUICKIE DESIGNS, INC, ITS EMPLOYEES, ITS CONTRACT SVC FIRMS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
REPORT OF ALLEGED" PRESSURE LIMIT CONTROL VALVE STUCK WHILE IN USE. DEVICE HIGH PRESSURE ALARMED AS INTENDED BY DESIGN ALERTING CAREGIVER TO RESPOND. NO PT HARM".
THREE ATTEMPTS WERE MADE TO OBTAIN REQUIRED INFO. LABELING-#1738. EVAL SUMMARY: TESTING BY MFR FOUND PRESSURE LIMIT CONTROL VALVE STICKS.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO A "FRACTURE OF THE SPIRAL CONNECTOR." 11/12/96 -UPON RECEIPT OF THE PHYSICIAN/SURGEONS OPERATIVE REPORT, IT STATED: "THE PROCEDURE ADDRESSED REMOVAL OF MALFUNCTIONING PENILE PROSTHESIS AND INSERTION OF A NEW CO'S TWO PIECE INFLATABLE PENILE PROSTHESIS. THE PT HAD RECEIVED PREOPERATIVE ANTIBIOTICS. AN INFRAPUBIC INCISION WAS MADE FROM THE BASE OF THE PENIS, EXTENDING IN A VERTICAL CORPOROTOMY WAS MADE, THERE WAS NO SIGN OF INFECTON. THE CONNECTING TUBING ON THE RIGHT SIDE, LEADING FROM THE RIGHT-SIDED CYLINDER, WAS FOUND TO BE NEARLY COMPLETELY TRANSECTED, AND THAT'S WHERE THE FLUID LEAK HAD OCCURRED." "THE PROSTHESIS INFLATED AND DEFLATED NICELY, LEAVING A SMALL AMOUNT OF FLUID IN THE CYLINDERS WHEN THE RESIPUMP WAS COMPLETELY INFLATED. THE PROCEDURE WAS WELL TOLERATED BY THE PT, WITHOUT COMPLICATIONS."
IN A RECEIVED QUESTIONNAIRE, THE PHYSICIAN INDICATED THE FOLLOWING: THE MALFUNCTION WAS DESCRIBED AS A "BREAK IN RIGHT SIDE CONNECTING TUBING FROM RESIPUMP TO CYLINDER," AT IMPLANT THE SAME MALFUNCTION WAS OBSERVED, THERE WAS NO APPARENT CONTRIBUTING FACTORS IN THE PATIENT HISTORY OR POSSITION OF THE IMPLANT NOTED. IN THE RECEIVED OPERATIVE REPORT THE PHYSICIAN INDICATED THE FOLLOWING: THE CONNECTING TUBING ON THE RIGHT SIDE, LEADING FROM THE RIGHT-SIDED CYLINDER, WAS FOUND TO BE NEARLY COMPLETELY TRANSECTED, AND THAT'S WHERE THE FLUID LEAK HAD OCCURRED. EACH CONNECTING TUBING WAS CUT SO THAT THE ENTIRE PROSTHESIS COULD BE REMOVED. THE PUMP AND TWO CYLINDERS WERE RECEIVED DETACHED, AND WERE EVALUATED BY THE MFR. MICROSCOPIC EXAMINATION WAS PERFORMED. THE DISTAL TUBING ENDS OF THE PUMP'S SERIALIZED OUTLET AND CYLINDER #1 SHOWED UNIFORM STRIATIONS, INDICATING CONTACT WITH SHARP INSTRUMENTATION, SUCH AS A SCALPEL OR SCISSORS. ROUGH AND IRREGULAR TUBING ENDS WERE DETECTED WITH THE NON-SERIALIZED OUTLET AND WITH CYLINDER #2, INDICATING THAT A TUBING TEAR OCCURRED. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCE'S EVALUATION, QA CONCLUDES THE FOLLOWING: THE CONTACT WITH SHARP INSTRUMENTATION OCCURRED DURING OR SUBSEQUENT TO EXPLANT, AND THEREFORE IS NOT RELATED TO THE RECEIVED COMPLAINT, A TUBING TEAR OCCURRED BETWEEN THE NON-SERIALIZED OUTLET AND CYLINDER #2, THE TUBING TEAR OCCURRED FROM STRESS(ES) EXPERIENCED BY THE DEVICE WHILE IN-VIVO, AND THIS TEAR WOULD CAUSE A FLUID LEAK FROM THE DEVICE WHILE IN-VIVO. THUS QA CONCLUDES THAT THIS COMPLAINT OCCURRED BECAUSE A TUBING TEAR CAUSED A DEVICE LEAKAGE WHILE IN-VIVO. ADDITIONALLY, QA DOES NOT CONFIRM THE REPORTED FRACTURE OF SPIRAL CONNECTOR. NO CONNECTORS WERE RECEIVED, NOR WAS ANY INFORMATION RECEIVED THAT INDICATES CONNECTORS WERE EVER IMPLANTED. ADDITIONALLY, THE PUMP TUBING ENDS AND THE CYLINDER TUBING ENDS FIT TOGETHER, DEMONSTRATING THAT NO CONNECTORS WERE USED WITH THIS DEVICE. HOWEVER, QA SUGGESTS THAT THE COMPLAINT MAY HAVE MEANT THAT THE SPIRAL SHAPED MONOFILAMENT COIL THAT IS LOCATED IN THE TUBING BETWEEN THE PUMP AND CYLINDERS WAS FRACTURED.
DURING A THROMBECTOMY ON A GRAFT, THE BALLOON RUPTURED. THE SURGEON WAS UNSUCCESSFUL IN RETRIEVING THE BALLOON AND TIP.
F1 USER FACILITY. EVALUATION OF PRODUCT WAS INCONCLUSIVE SINCE ONLY CATHETER BODY WAS RETURNED. CATHETER BODY IS IN CONDITION..
REPORT OF ALLEGED "PRESSURE LIMIT CONTROL VALVE STUCK WHILE IN USE. ALARMED LOW PRESSURE CONTINUOUSLY. DEVICE CHANGED OUT."
THREE ATTEMPTS WERE MADE TO OBTAIN REQUIRED INFO. LABELING-#1738. EVAL SUMMARY: TESTING BY MFG FOUND PRESSURE LIMIT CONTROL ASSEMBLY STICKS. VISUAL EXAM OF PRESSURE LIMIT CONTROL ASSEMBLY NOTED IT TO BE CONTAMINATED. MFR HAS ADVISED CUSTOMER TO FOLLOW RECOMMENDED INSTRUCTIONS FOR MORE FREQUENT FILTER CHANGE.
A VAGUE REPORT WAS RECEIVED THAT THE INFUSION PUMP WAS INFUSING FASTER THAN THE PROGRAMMED RATE. NO ADDITIONAL SPECIFIC INFO WAS ABLE TO BE RECEIVED. NO PT INJURY WAS REPORTED.
SECTION F COMPLETED BY THE MFR. FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPECIFICATION.
WHILE ATTACHED TO A PT THE VENTILATOR SET AT 60% AND PERCENTAGE ROSE ABOVE 70% TO APPROX 74%. NO SETTINGS ARE AVAILABLE.
100-THE REPLACED MODULE WILL BE SENT TO THE MFR FOR EVAL.
DURING SERVICE OF PRODUCT A MOTOR STALL, WITH AUDIBLE HIGH AND LOW PRESSURE ALARMS, WAS FOUND DUE TO CAPACITOR C8 ON THE MOTOR BOARD BEING OUT OF SPECIFICATION. REPLACED C8.
DISTRIBUTOR RECEIVED INFO ON AN EXPLANT REPORT THAT THE MFR'S SENSE PACE LEADS WERE CAPPED DUE TO A LEAD FRACTURE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC BURCH PROCEDURE. IT WAS REPORTED THE EAS JAMMED AND WOULD NOT WORK. A NEW EAS WAS OPENED AND IT WORKED FINE. THERE WAS NO CONSEQUENCE TO THE PT.
DEVICE RETURNED WITH NO LOT ID. INSTRUMENT RECEIVED WITH A FORMED, STAPLE JAMMED IN CARTRIDGE NOSE. RIGHT KICKOFF LEG WAS OBSERVVED TO BE BENT. BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE RPT'D INSTRUMENT "JAMMED AND WOULD NOT WORK" DURING SURGERY MAY HAVE BEEN DUE TO A BENT KICKOFF LEG WAS ALSO OBSERVED TO BE BENT. THE INSTRUMENT WAS CYCLED AND FIRED THE REMAINING 8 STAPLES WITHOUT INCIDENT. IT WAS CONCLUDED HOWEVER, THAT THE BENT KICKOFF SPRING LEG MAY HAVE CAUSED THE RPT'D INCIDENT DURING SURGERY. NO CONCLUSION COULD BE REACHED AS TO HOW THE KICKOFF SPRING LEG HAD BECOME BENT. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP. DOES NOT FIRE/MISFIRE OR CUT. THERE WAS NO CONSEQUENCE TO THE PT.
DAMAGED FIRING MECHANISM. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGE FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
PRODUCT EVALUATION SUMMMARY: PRODUCT WITHIN SPECIFICATION
PER THE INFO PROVIDED TO CO THE PHYSICIAN/SURGEON'S OFFICE THROUGH MEANS OF AN OPERATIVE REPORT, IT STATED: "THE PT'S CHIEF COMPLAINT, 'MY PUMP DOES NOT WORK', PRESENT ILLNESS: "PT IS A 51 YEAR OLD WHITE MALE WHO UNDERWENT AN INITIAL PENILE IMPLANT BY ME IN 1987. HE HAS ORGANIC IMPOTENCE SECONDARY TO IDDM (INSULIN DEPENDANT DIABETES MELLITUS) AND HAS HAD THREE PREVIOUS PUMP REPLACEMENTS BECAUSE OF MATERIAL DEFECT." PROCEDURE: "SCROTAL EXPLANTATION WITH REPLACEMENT OF INFLATABLE PENILE IMPLANT PUMP." "CARE WAS TAKEN TO GO THROUGH THE VARIOUS DARTOS LAYERS AND THE PUMP WAS IDENTIFIED AND FOUND TO BE INTACT. THE CAPSULE TO THE PUMP WAS THEN OPENED AND THE FLUID WAS ASPIRATED. THE PUMP WAS THEN EXAMINED AND THE LINE FROM THE PUMP TO THE RIGHT CYLINDER WAS BROKEN APPROX 1CM ABOVE THE PUMP AND 2CM AWAY FROM THE CONNECTION BETWEEN THE PUMP LINE AND THE CYLINDER. THE PUMP WAS REMOVED WITH MODERATE DIFFICULTY IN ORDER TO SAVE AS MUCH LENGTH TO THE LINES TO THE CYLINDERS AND RESERVOIR AS POSSIBLE. A NEW PUMP WAS THEN OBTAINED. THE PT TOLERATED THE PROCEDURE WELL. THE PT BECAME ACTIVE AND VOIDED AND WAS DISCHARGED ON APPROPRIATE PAIN MEDICATION AND ANTIBIOLTIC OF KEFTABS 500 BID FOR 5 DAYS."
IN RECEIVED INFO PHYSICIAN STATED THAT ONCE PROSTHESIS WAS REMOVED AND EXAMINED IT WAS NOTED THAT "LINE FROM PUMP TO RIGHT CYLINDER WAS BROKEN." PHYSICIAN ALSO STATED THAT TUBINGS FROM LEFT CYLINDER AND RESERVOIR TO PUMP WERE INTACT. PHYSICIAN FURTHER STATED THAT TUBING LENGTH WAS NOT OBSERVED TO BE EXCESSIVE OR INADEQUATE, THAT DEVICE WAS NOT IN A POSITION THAT WOULD HAVE CAUSED STRESS(S), AND THAT THEREE WAS NO INFO APPARENT IN PT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE. QA WAS UNSUCCESSFUL IN SECURING EXPLANTED PROSTHESIS FOR EVAL. WITHOUT BENEFIT OF ANALYZING EXPLANT, QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PRECLUDED FROM COMMENTING ON CONDITION OF PROSTHESIS. SHOULD EXPLANTED DEVICE BECOME AVAILABLE, OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES.
WHILE CONNECTED TO A PT, THE CUSTOMER REPORTED A BURNING SMELL FROM THE VENTILATOR AND THE VENTILATOR'S FRONT PANEL LAMPS FLASHED ERRATICALLY. THERE WAS NO PT INJURY. ALL ALARMS WERE ACTIVATED. UPON INSPECTION OF THE VENTILATOR, THE FSE FOUND HEAT DAMAGE TO THE PC 1607 BOARD ON THE EMPTY CONNECTOR NEAR THE PC 1615 BOARD.
THE BOARD WAS EVALUATED, RESIDUES OF LIQUID WERE FOUND ON THE POINT WHERE THE SHORT CIRCUIT OCCURRED.
END USER HOSP NOTED DRAWING BACK AIR FROM THE CONNECTION WITH THE ROTATING ADAPTOR OF THE MANIFOLD. THERE WAS NO PT INJURY.
VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A DAMAGED O-RING IN THE ROTATING ADAPTOR OF THE MANIFOLD. THE O-RING APPEARED TO HAVE BEEN IMPROPERLY SEATED IN THE R/A WHICH RESULTED IN THE O-RING BEING SHEARED. CO HAS RECENTLY INSTALLED AN OPTICAL MONITORING SYSTEM IN THE MANIFOLD ASSEMBLY EQUIPMENT WHICH WILL DETECT AND REJECT SIMILAR DEFECTS. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF NAMIC USA CORP THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
RETURNED SHEATH WITHIN SPECIFICATION. ABLE TO PASS RETURNED BALLOON MEMBRANE THROUGH SHEATH AND HEMOSTASIS VALVE ASSEMBLY WITHOUT DIFFICULTY. NO DEFECT FOUND IN RETURNED BALLOON CATHETER OR SHEATH.
THE IAB WAS INSERTED ON 3/15/96 AND WAS REMOVED ON 3/16/96 AFTER 12 HOURS OF IABP.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DSG22 RATCHET MECHANISM WOULD NOT RELEASE. THERE WAS NO CONSEQUENCE TO THE PT.
D5:INFO AVAILABLE. RESULTS OF EVAL: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED WITH THE RATCHET SWITCH IN THE OFF POSITION AND IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS TESTED AND PERFORMED WITHIN DESIGN SPECIFICATIONS. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE CUSTOMER REPORTED COULD NOT BE REPEATED. PLEASE REFER TO THE PACKAGING INSERT FOR RATCHET SWITCH OPERATION INSTRUCTIONS. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. WE STRIVE TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE OUR PRODUCTS.
DURING A FOLLOW-UP APPROX ONE MONTH AGO, THE MAGENT RATE OF 83-84 PPM WAS OBSERVED. AS PER THE DR'S REQUEST, THE DEVICE WAS REPLACED. WHEN TRYING OBSERVE THE PT'S INTRINSIC RATE BY DECREASING THE PACING RATE DOWN TO 50 PPM, NO PACING SPIKES WERE OBSERVED ON THE ECG. AFTER EXPLANT, THE DEVICE SHOULD NOT BE REQUIRED.
THE OBSERVED NO OUTPUT WAS THE RESULT OF LOW MODULE VOLTAGE DUE TO A MALFUNCTION IN THE POWER SUPPLY SOURCE, BT 1.
THE IAB WAS INSERTED INTO THE PT ON 08/13/96. AFTER THE IABP FOR APPROX 2 DAYS, THE PUMP STARTED ALARMING " HIGH RESISTANCE". BLOOD WAS NOTED IN THE CATHETER TUBING. THE IAB WAS REMOVED ON 08/15/96 AND ANOTHER IAB WAS NOT INSERTED.
IT WAS REPORTED A PROBLEM WITH LOW AUGMENTATION OCCURRED DURING BALLOON PUMPING. THE PT WAS TRANSFERRED TO ANOTHER MFR'S INTRA-AORTIC BALLLON PUMP WITHOUT FURTHER INCIDENT. THERE WERE NO PT COMPLICATIONS INVOLVED. NO FURTHER DETAILS ARE AVAILABLE. THE BIO-MED DEPT AT THE USER FACILITY EVALUATED THE BALLOON PUMP. THEY WERE UNABLE TO DUPLICATE ANY PROBLEMS ASSOCIATED WITH THE LOW AUGMENTATION PROBLEM. THE PRESSURE WAS SET FOR 200 MMHG. A FULL PREVENTATIVE MAINTENANCE WAS PERFORMED INCLUDING 2500 HR PART REPLACEMENT AT WHICH TIME THEY RECEIVED A "VOLUME LOSS" ALARM. AN ATTEMPT TO PURGE THE SYSTEM RESULTED IN AN "INSUFFICIENT VACUUM" MESSAGE. AN INTERMITTENT CONNECTION (TB5) ON THE DC MONITOR CONTROL BOARD HAD CAUSED THE COMPRESSOR TO SHUT OFF. THE CONNECTOR WAS RESOLDERED AND THE PROBLEM COULD NOT BE DUPLICATED. IT WAS INDICATED THE PRESSURE WAS SET FOR 200 MMHG. THE OPERATING MANUAL DISCUSSES THE PRESSURE GAUGE AND INDICATES SETTINGS BETWEEN 225MMHG-300MMHG FOR OPTIMAL INFLATION CHARACTERISTICS.
A "VOLUME LOSS" ALARM WAS NOTED FOLLOWING INSERTION OF AN INTRA-AORTIC BALLOON CATHETER. ANOTHER INTRA-AORTIC BALLOON WAS PLACED WITHOUT INCIDENT. THERE WERE NO PT COMPLICATION INVOLVED. NO FURTHER DETAILS COULD BE OBTAINED REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE CATHETER WAS RECEIVED WITH THE BALLOON UNFURLED AND EVIDENCE OF WING SET MEMORY WAS PRESENT. THE CATHETER WAS EXTREMELY CLEAN WITH NO EVIDENCE OF BIOLOGICAL CONTAMINATION. MICROSCOPIC EXAM REVEALED NO ANOMALIES OR ABRASIONS OF THE BALLOON MATERIAL. ALTHOUGH THE USER FACILITY QUESTIONED A BALLOON RUPTURE, CO WAS UNABLE TO DUPLICATE THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE. SINCE CO WAS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT, CO DOES NOT ATTRIBUTE IT TO THE DEVICE.
H6 - 86 (OTHER - MICROSCOPIC EXAM). INFO SUPPLIED IN SECTION F WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFO NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA.
DIALYSIS TRETMENT WAS INITIATED WITHOUT DIFFICULTY NEAR (R) SUBCLAVIAN CATHETER AT 4:05 PM. APPROX TWO HRS INTO TREATMENT NURSE OBSERVED THAT PT DID NOT LOOK WELL. BP 80/90 (PRIOR BP 152/72). THE NURSE PUT THE PT'S CHAIR BACK TO ELEVATE HER FEET AND WENT TO THE MACHINE TO ADMINISTER SALINE. SHE NOTED A LARGE AMOUNT OF BLOOD ON THE FLOOR. THE ARTERIAL LINE WAS NOTED TO BE KINKED IN THE BLOOD PUMP AND BLOOD WAS LEAKING ON THE FLOOR. PT'S BLOOD WAS RETURNED, TREATMENT WAS TERMINATED AND ADD'L SALINE WAS ADMINISTERED. THE PT REFUSED TO GO TO THE ER FOR FURTHER EVALUATION. SHE WAS DISCHARGED FROM THE UNIT BP 130/70 SITTING 120/60 STANDING. THE NEXT MORNING FOLLOWING THE EVENT THE BLOOD PUMP ON THE MACHINE USED DURING THE ABOVE INCIDENT WAS MAKING A CLANKING NOISE WHEN THE TECH TURNED ON THE PUMP TO PRIME THE ARTERIAL BLOOD LINE. A SPRING AND OTHER PARTS OF THE BLOOD PUMP FELL TO THE FLOOR WHEN THE ARTERIAL LINE WAS TAKEN OUT TO INVESTIGATE THE NOISE. A NEW BLOOD PUMP WAS PLACED ON THE MACHINE AFTER FURTHER EVALUATION. IT WAS FELT THAT IMPROPER FUNCTIONING OF THE BLOOD PUMP CONTRIBUTED.
PHYSICIAN PULLED SHEATH OFF INTRODUCER AND TOP OF INTRODUCER BROKE, CAUSING BLEEDING.
THE PT HAD FOLLOW-UP IN 6 AND ALL WAS OK. 10/16/96, VIA TRANSTELPHONIC MONITORING, THERE WAS NO OUTPUT WITH OR WITHOUT MAGNET.
THE OBSERVED NO OUTPUT WAS THE RESULT OF LOW MODULE VOLTAGE DUE TO A MALFUNCTION IN THE PACER POWER SOURCE, BT1.
END USER HOSP RETURNED DEVICE BECAUSE OF NON-FUNCTIONING GAUGE. THERE WAS NO PT INJURY.
DISASSEMBLY OF THE INFLATION DEVICE REVEALED EXCESS GLUE COVERING THE GAUGE FILTER. MFG INSPECTION PROCESSES HAVE BEEN REVISED TO ADDRESS THIS ISSUE. THIS PRODUCT WAS MFG PRIOR TO THESE CHANGES BEING MADE. UNITS FROM THIS LOT NUMBER WERE MFG SOLELY FOR INTERNATIONAL DISTRIBUTION AND WERE NOT DISTRIBUTED IN THE UNITED STATES. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF NAMIC USA CORP. THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
MALFUNCTIONING PUMP. MORPHINE DRIP ORDERED @ 7:00PM, BAG EMPTY @ 11:30PM. PT LETHARGIC, DIFFICULT TO AROUSE WITH DECREASED RESPIRATIONS. NARCAN 1/2 AMP SLOW IVP AND NARCAN 1 AMP IN 50CC NS IV OVER 2 HRS GIVEN.
PUMP WAS NOT RETURNED TO THE MFR FOR ANALYSIS. MFR RECEIVED A REPORT FROM HOSPITAL BIOMEDICAL ENGINEER STATING THE PUMPING MECHANISM WAS BROKEN AND THERE WAS NO MECHANISM ALARM CIRCUITS IN THIS PUMP. THEY INDICATED THEY REPLACED THE PUMPING MECHANISM ON CHANNEL B AND ADDED MECHANISM ALARM CIRCUITS TO THIS PUMP BEFORE RETURNING IT TO THE FLOOR.
INTRODUCER (PLACED RIJ - SURGERY 2/26/96) CRACKED INTO THREE PIECES WHEN PT VOMITED.
THE IAB WAS INSERTED INTO THE PT'S RIGHT FEMORAL ARTERY ON 08/12/96. AFTER ABOUT 12 HOURS OF IABP ON 08/13/96, BLOOD BACKED UP TO THE PUMP SAFETY CHAMBER.
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ASLOS COMPLETED BY THE MFR. NO MEDWATCH ROM WAS RCEIVED FROM THE INITIAL REPORTER OR PORDUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITSIH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. THE PNETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. DEVICE LABELLING CODE: 1738.
DURING AN ADMINISTRATION OF BLOOD USING THE PUMP, THE PUMP APPEARED TO BE OPERATING HOWEVER NO FLUID WAS BEING ADMINISTERED. IT IS NOT KNOWN HOW LONG THE PUMP WAS OPERATING BEFORE THIS WAS OBSERVED. THE IV SITE HAD TO BE RESTARTED, HOWEVER THE INFUSION WAS CONTINUED USING A DIFFERENT INFUSION PUMP. NO ADDITIONAL PT INTERVENTION WAS REQUIRED.
SECTION F COMPLETED BY THE MFR. THE INFUSION PUMP WAS NOT RETURNED TO CO FOR EVALUATION. BASED ON THE DESCRIPTION OF THE OCCURRENCE THE MOST LIKELY CAUSE WAS IMPROPER LOADING OF THE INFUSION PUMP BY THE OPERATOR.
CHILD FOUND LYING IN POOL OF BLOOD. UNABLE TO QUANTIFY EXACT AMOUNT. IV TUBING FOUND TO HAVE PROXIMAL IV PORT TO THE PT FOUND WITHOUT RUBBER PIECE, ALLOWING BLOOD TO FLOW FROM PT OUT ONTO BED LINEN. IV ATTACHED TO CENTRAL LINE IN CHILD'S (R) CHEST. CENTRAL LINE HAD BEEN ACCESSED FOR LAB WORK APPROX 2 HRS EARLIER. WITHIN 24 HRS OF THE EVENT, THE CHILD'S HEMOGLOBIN DROPPED 2.9 GRAMS, NECESSITATING A BLOOD TRANSFUSION.
THE RPTR INDICATED THAT NO VALUES (RATE, AMPLITUDE, IMPEDANCE, ETC) ARE DISPLAYED. THERE WAS NO PT INVOLVED WITH THIS DEVICE.
ANALYSIS SUMMARY: THE DEVICE IS WITHIN PRODUCT SPECS.
THE DEVICE PACKAGE WAS MISLABELED WITH THE WRONG PRODUCT NUMBER. THE EVENT OCCURRED DURING SURGERY AND NO REPLACEMENT DEVICE COMPONENT WAS AVAILABLE. THE PT RECEIVED THE DEVICE THAT WAS APPARENTLY MISLABELED. NO COMPLICATIONS WERE REPORTED AND THE SURGERY WAS NOT DELAYED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED THE EZ35W WAS CLAMPED ACROSS THE BROAD AND ROUND LIGAMENT. THE WHITE HANDLE WAS DIFFICULT TO CLOSE, AND UPON FIRING THE BLACK HANDLE, AROUND LIGAMENT. THE WHITE HANDLE WAS DIFFICULT TO CLOSE, AND UPON FIRING THE BLACK HANDLE, A LOUD CRACKING NOISE WAS HEARD. THE JAWS LOCKED ON TISSUE AND WERE FORCED OPEN. THE DEVICE PARTIALLY FIRED AND CUT. THIS OCCURRED ON THE FIFTH FIRING. A SECOND EZ35W WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
H6; EVALUATION CODE #400(OTHER): FIRING MECHANISM DAMAGED. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFORMATION RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: THE PINION GEAR HAS BEEN MODIFIED BY A MATERIAL CHANGE FROM PLASTIC TO METAL. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO A "FLUID LOSS", SECONDARY TO A "TUBING FRACTURE AT LEVEL OF STRAIN RELIEF." AS REPORTED TO CO, THE PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED.
ACCORDING TO AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 2/13/91 AND REVISED ON 10/14/96 DUE TO A "TUBING FRACTURE" AT "CENTER CYLINDER TUBING [AT] LEVEL OF STRAIN RELIEF" AND "FLUID LOSS." REQUESTS FOR EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER DEVICE NOR INFO HAVE BEEN RECEIVED. WITHOUT BENEFIT OF ANALYZING EXPLANT WITHOUT REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON CONDITION OF DEVICE OR EVENTS SURROUNDING THIS INCIDENT. SHOULD EXPLNATED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES.
THE TX60B WAS USED DURING A GASTRIC BYPASS. THE SURGEON FIRED THE DEVICE ACROSS THE SMALL BOWEL, SET THE DEVICE ASIDE AND THEN TOOK THE BOWEL HE JUST STAPLED AND "MILKED" IT AND GOT LEAKING OF INTESTINAL CONTENTS. THE SURGEON THEN OVERSEWED THE STAPLE LINE. THERE WERE TWO LEAKS IN THE STAPLE LINE. THE SURGEON HAS THE DEVICE AND WAS GOING TO SEND TO RISK MANAGEMENT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7;D10: INFO UNAVAILABLE. 10/22/96 0945 LEFT MESSAGE AND 800# MD TO CALL BACK. 10/23/96 NNCL SENT. D5,6;H4,6: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
PER THE INFO PROVIDED TO CO BY SURGEON/PHYSICIAN THROUGH MEANS OF A WRITTEN RESPONSE TO THE REQUEST FOR ADD'L INFO, THE DEVICE WAS REMOVED AS "IT WAS FLAT; NO FLUID IN SYSTEM." THE SURGEON ALSO OBSERVED "FLAT IMPLANT, NO OBVIOUS LEAK." AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH CO'S 2-PIECE INFLATABLE PENILE PROSTHESIS.
A RETURNED QUESTIONNAIRE FROM THE PHYSICIAN INDICATED THE FOLLOWING: THERE WAS NOT A SPECIFIC LEAKAGE SITE OBSERVED, THE DOCTOR DID NOT NOTICE WHETHER THE TUBING WAS KINKED OR TWISTED AROUND EACH OTHER WHEN HE OPENED THE POCKET, WHEN THE DEVICE WAS IMPLANTED THERE WAS NOT EXCESSIVE NOR INADEQUATE TUBING LENGTHS OBSERVED, NOTHING WAS NTOED IN THE POSITIONING THAT MAY HAVE CAUSE STRESS(ES) TO THE DEVICE, THERE WAS NO APPARENT INFO IN THE PT'S HISTORY WHICH MAY HAVE CONTRIBUTED TO THIS OCCURRENCE, AND THE DEVICE DID NOT CONTACT ANY UNSHOD, SHARP INSTRUMENTATION DURING OR SUBSEQUENT TO REMOVAL. TWO CYLINDERS AND A PUMP WERE RECEIVED AND EVALUATED BY THE MFR. DURING FUCTIONAL TESTING A LEAKAGE SITE WAS OBSERVED IN CYLINDER #2 AND AT THE PUMP'S SERIALIZED STRAIN RELIEF. MICROSCOPIC EXAMINATION OF THE LEAKAGE SITE SHOWED UNIFORM STRIATIONS, INDICATING CONTACT WITH SHARP INSTRUMENTATION, SUCH AS SCISSORS OR SCAPEL. THE CROSS SECTIONAL SURFACES OF THE PUMP TUBING LEAKAGE SITE WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. BASED ON THE RECEIVED INFO AND QUALITY ASSURANCE'S EXAMINATION AND TESTING, QA CONCLUDES THAT TWO LEAKAGE SITES EXISTED WITH THIS DEVICE. BASED ON THE DURATION THIS DEVICE WAS IMPLANTED, THE LEAK IN THE CYLINDER WAS CAUSED BY CONTACT WITH SHARP INSTRUMENTATION DURING OR SUBSEQUENT TO EXPLANT SURGERY. THUS, THIS LEAK WAS NOT ASSOCIATED WITH THE RECEIVED COMPLAINT. THE LEAK IN THE PUMP'S TUBING RESULTED FROM STRESS(ES) EXPERIENCED BY THE DEVICE WHILE IN-VIVO, AND THE LEAK WAS RESPONSIBLE FOR THE REPORTED FLAT IMPLANT WITH A LOSS OF FLUID.
THE DEVICE WAS USED DURING A PROCEDURE. IT WAS REPORTED BY THE REP. THE INSTRUMENT MISFIRED ON THE FIRST FIRING. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B3,6,7; D10, H4: INFO NOT PROVIDED BY AFFILIATE. CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "MISFIRED" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE TO ENSURE IT FUNCTIONS PROPERLY.
AN INTRA-AORTIC BALLOON PUMP WAS ALARMING "VOLUME LOSS" AFTER APPROX 2 1/2 WEEKS OF COUNTERPULSATION. THE PT WAS TRANSFERED TO ANOTHER INTRA-AORTIC BALLOON PUMP WITHOUT INCIDENT. THERE WERE NO PT COMPLICATIONS INVOLVED. NO FURTHER DETAILS ARE AVAILABLE. THE BIO-MED DEPT AT THE USER FACILITY EVALUATED THE BALLOON PUMP. CONDENSATION WAS NOTED IN THE EXTENSION TUBING. A HELIUM LEAK WAS ALSO NOTED. THE HELIUM VALVE WAS CHANGED AND THE PUMP FUNCTIONED AS INTENDED. THE PUMP WAS PLACED BACK IN SERVICE. THE OPERATING MANUAL OUTLINES THE PROCEDURE FOR LOCATING THE POSSIBLE CAUSES FOR A "VOLUME LOSS/SLOW" ALARM. MAINTENANCE SCHEDULE OUTLINES ROUTINE MAINTENANCE STEPS WHICH ADDRESS THIS ISSUE.
ON 10/18/96, THE MFR RECEIVED A FAX FROM ITS DISTRIBUTOR WHICH STATED THAT UPON INSPECTION, IT WAS NOTED THAT ELEVEN (11) OF THE DEVICES CONTAINED FOREIGN MATERIAL CONTAMINATION AS FOLLOWS: (2) PIECES CONTAINED A "BLUE OR WHITE FOREIGN MATERIAL", (6) PIECES CONTAINED A HAIR OF FIBER IN THE PACKAGING, (1) PIECE CONTAINED A "DEPOSIT OBSERVED ON THE CATHETER" AND (2) PIECES HAD BROKEN PACKAGES.
THE MFR HAS COMPLETED ITS EVALUATION OF THE RETURNED DEVICES AND THE RESULTS ARE AS FOLLOWS: TWENTY PIECES WERE RETURNED AND EVALUATED. VISUAL EXAMINATION CONFIRMED THE DISTRIBUTOR'S REPORT OF (2) PIECES CONTAINING A BLUE FOREIGN MATERIAL, (6) PACKAGES WITH FIBERS IN THE POUCH AND (1) PIECE WITH A DEPOSIT ON THE CATHETER. IN ADDITION, (9) ADDITIONAL PIECES CONTAINED PARTICLES IN THE POUCHES AND ON THE COMPONENTS. THE DISTRIBUTOR'S REPORT OF (2) BROKEN PACKAGES WAS NOT CONFIRMED BY THE MFR'S EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CATALOG/LOT NUMBER AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CATALOG/LOT NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. THE MFR WILL RETURN THE CONTAMINATED PRODUCT TO ITS VENDOR. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.
EMT'S RESPONDED TO A PERSON, DESCRIBED AS CONSCIOUS AND AWARE. THE PT WAS CONNECTED TO THE DEVICE WITH A 3 LEAD PT CABLE AND ECG ELECTRODES FOR CARDIAC MONITORING. THE OPERATOR PUSHED THE "ANALYZE" BUTTON, THE DEVICE ALARMED "ATTACH DEFIB CABLES", THE OPERATOR REPLACED THE 3 LEAD PT CABLE AND ECG ELECTRODES, PRESSED ANALYZE AGAIN AND THE DEVICE BEGAN TO CHARGE. POWER TO THE DEVICE WAS CYCLED TO DUMP THE CHARGE AND NO ADVERSE AFFECTS TO THE PT WERE REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.
INFO REGARDING PROPER OPERATION WAS REVIEWED WITH THE CUSTOMER BY THE LOCAL CO SVC REP.
THE DEVICE WAS USED DURING AN LAPAROSCOPIC HYSTERECTOMY. INSTRUMENT WAS FIRED TWICE AND MISFIRED. THERE WAS NO DIFFICULTY IN RELOADING AND INSTRUMENT WAS NOT FIRED OVER AN EXISTING STAPLE LINE. THERE WAS NO CONSEQUENCE TO THE PT.
A1, 2,4; B3,6,7; D10; H4: INFO NOT PROVIDED BY AFFILIATE. CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "MISFIRED" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
ROUTINE COMPLAINT INVESTIGATON CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED. ANALYSIS SHOWS THAT THIS CALIBRATON CODE, IF USED TO PERFORM AN ASSAY WITH TEST STRIPS FROM ANY LOT, COULD RESULT IN HIGHER THAN EXPECTED VALUES. NO INJURIES REPORTED IN THE FIELD.
ALL AVAILABLE INFO REGARDING THIS COMPLAINT WAS INVESTIGATED AND REVIEWED. ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT # S0005) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED.
END USER HOSP REPORTED WHAT THEY BELIEVED WAS A DEFECTIVE OR CRACKED MANIFOLD. THEY HAD NOTED MICRO BUBBLES DURING SYRINGE ASPIRATION. THERE WAS NO PT INJURY.
VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A DAMAGED O-RING IN THE ROTATING ADAPTOR OF THE MANIFOLD. THE O-RING APPEARED TO HAVE BEEN IMPROPERLY SEATED IN THE R/A WHICH RESULTED IN THE O-RING BEING SHEARED. CO HAS RECENTLY INSTALLED AN OPTICAL MONITORING SYSTEM ON THE MANIFOLD ASSEMBLY EQUIPMENT WHICH WILL DETECT AND REJECT SIMILAR DEFECTS. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF NAMIC USA CORP THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
PT (FEMALE, AGE 31 YRS) ENTERED EMERGENCY ROOM ON 10/7/96 COMPLAINING OF PAIN IN LOWER ABDOMEN. PT DETERMINED TO HAVE SYMPTOMS OF SEPTICEMIA. PT ALSO DETERMINED TO HAVE DISSEMINATED INRAVASCULAR COAGULATION (DIC) AND WAS RAPIDLY DECOMPENSATING DURING HOSPITALIZATION. PT DRAWN FOR STAT HUMAN CHORIONIC GONADOTROPIN TEST AT 1:00PM SAME DAY. VALUE DETERMINED TO BE 106 MIU/ML BY SUBJECT DEVICE. (EXPECTED VALUES IN NON-PREGNANT FEMALES LESS THAN 5 MIU/ML.) ULTRASOUND  PERFORMED ON PT INDICATED ABDOMINAL FLUID; PT SUSPECTED OF POSSIBLE ECTOPIC PREGNANCY. LAPAROSCOPY PERFORMED ON 10/7/96; ACCORDING TO PATHOLOGIST, NO INDICATION OF ECTOPIC PREGNANCY FOUND. ADDITIONAL HCG TEST ORDERED POST-LAPAROSCOPY (129.7 MIU/ML) AND, AGAIN, ON MORNING OF 10/8/96 (54.4 MIU/ML). PT DEMONSTRATED MULTIPLE SYSTEM FAILURE, ELEVATED LIVER ENZYMES AND KIDNEY FAILURE. MASSIVE SEPSIS DETERMINED TO BE DUE TO STREPTOCOCCUS PNEUMONIAE. PT DECEASED ON OR ABOUT 10/9/96. UPON DEATH, NO AUTOPSY PERFORMED TO CONFIRM LAPAROSCOPY FINDING.
THE LEAD WIRE WAS FRACTURED AND RETURNED WITH THE PACER/LEAD.
REF F10 OF THIS FORM FROM THE EVENT PROBLEM CODES. THE FRACTURE OF THE COIL PROXIMAL TO THE PATCH BOOT WAS THE RESULT OF FATIGUE.
A FACILITY AMBULANCE WAS INVOLVED IN A VEHICULAR ACCIDENT WHICH CAUSED THE AMBULANCE TO ROLL OVER. THE DEVICE WAS FOUND LOOSE INSIDE, APPARENTLY HAVING FALLEN FROM ITS STORAGE AREA. THE DEVICE WAS TESTED BY THE FACILITY AND ACCORDING TO THE REPORTER, APPEARED TO OPERATE PROPERLY. THE DEVICE WAS USED IN AN UNKNOWN NUMBER OF CALLS, FOR THE REMAINDER OF THE DAY INVOLVING CARDIAC MONITORING, IN WHICH THE OPERATOR COMPLAINED THE DEVICE'S CRT AND CHART RECORDER DISPLAYED EXCESSIVE ARTIFACT. NO ADVERSE AFFECTS TO ANY PTS WERE REPORTED AS A RESULT OF THE REPORTED MALFUNCTION.
IN AN EVAL OF THE DEVICE BY CO, A COMPLETE FUNCTIONAL TEST WAS PERFORMED AND PROPER OPERATION WAS OBSERVED. THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.
ALL AVAILABLE INFO REGARDING THIS COMPLAINT WAS INVESTIGATED AND REVIEWED. ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT #SOO84) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATION. NO PHYSICAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR, THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELELCTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT EVALUATION SUMMARY: PRODUCT WITHIN SPECIFICATION.
DURING FEEDING TUBE INSERTION, AS THE PHYSICIAN WAS REMOVING THE TUBE OUT OF THE STOMACH INCISION, THE INTRODUCER SNAPPED, LEAVING THE ENTIRE TUBE IN THE PT. TUBE REMOVED WITH A SNARE AND A NEW TUBE INSERTED.
BLOOD NOTICED IN CATHETER TUBING, BALLOON CATHETER REMOVED, NO REPLACEMENT BALLOON CATHETER INSERTED.
IT WAS REPORTED THE INSTRUMENT WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED THE HANDLE BROKE DURING THE PROCEDURE ON THE 2ND FIRING. IT WAS REPORTED THE INSTRUMENT WAS DIFFICULT TO FIRE, BUT THEY KEPT ON TRYING. THERE WAS NO CONSEQUENCE TO THE PT.
H6: CODE 400(OTHER): FIRING MECHANISM DAMAGEDD5,6: H4: INFORMATION UNAVAILABLE
THE RPTR INDICATED THAT THE UNIT IS GIVING ABNORMAL DIAGNOSTIC DATA.
REF F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THIS IS A KNOWN ANOMALY WHEN YOU CLEAR THE DIAGNOSTICS DURING A HIGH RATE EVENT.
ON 4/20/95 PT HAD A DUAL CHAMBER PERMANENT PACEMAKER INSERTED FOR SICK SINUS SYNDROME AND A V BLOCK. THE PT COMPLAINED OF SHORTNESS OF BREATH, WEAKNESS, FATIGUE AND EXHAUSTION AND HAD A LONG RHYTHM STRIP OF INAPPROPRIATE SENSING AND CAPTURE. ON 2/8/96 THE PT WAS TAKEN TO THE OR DUE TO PACEMAKER FAILURE FOR REMOVAL OF THE ATRIAL LEAD AND REPOSITIONING OF THE VENTRICULAR LEAD.
PT HAD AN IAB IN PLACE, PT PULLED OUT. A 2ND IAB WAS REPLACED AFTER 24HRS BLOOD IN TUBING WAS NOTED. IAB WAS REMOVED. PT IS FINE.
H-11-ALL UNK INFO REQUESTED BUT NOT RECEIVED. H-11-SECTION F PROVIDED BY MFR. H-11-SECTION F10 DEVICE CODE 1746 LABEL.
THE NEEDLE DETACHED FROM THE HUB OF THE CANNULA. NO PT INJURY WAS EXPERIENCED.
ADD'L INFO HAS BEEN SOUGHT FROM THE USER FACILITY BUT NOT RECEIVED BY THE MFR. THE RETURNED SAMPLE WAS EVALUATED AND THE GLUE BOND CONNECTING THE CANNULA TO THE HUB HAD FAILED. INFO SUPPLIED IN SECTION F WAS PROVIDED BY THE MFR, NOT THE USER FACILITY. THIS REPORT WAS MAILED IN TO FDA ON : 11/14/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TYO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEVECTIVE OR HAS CAUSED SERIOUS INJURY.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP STAPLES JAMMED IN THE NOSE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B3, 6,7; D10; E3: INFO NOT PROVIDED BY AFFILIATE. D5, 6; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
UPON INITIATION OF THERAPY THE IAB WAS REMOVED DUE TO BALLOON LINE BLOCK ALARM. ONCE REMOVED THE IAB WAS NOTED TO MANUALLY INFLATE BUT WOULD NOT DEFLATE. ANOTHER IAB WAS INSERTED AND CASE CONTINUED SUCCESSFULLY.
H-11-ALL UNK INFO REQUESTED NOT RECEIVED. H-11-SECTION F PROVIDED BY MFR.
HOSPITAL PERSONNEL WERE ATTENDING TO A PT IN FULL CARDIAC ARREST. DURING AN ATTEMPT TO SHOCK THE PT, THE REPORTER STATED THE ELECTRODES WOULD NOT STAY ATTACHED TO THE PT AND THE CABLE KEPT COMING DETACHED. THE REPORTER VERIFIED THE DEVICE DID NOT TRANSFER THE ENERGY TO THE PT, BUT DID AN INTERNAL DUMP OF THE STORED ENERGY. A BACK UP UNIT WAS OBTAINED AND USED TO TREAT THE PT. THE PT WAS NOT RESUSCITATED. THE REPORTER STATED THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THIS OPINION WAS BASED ON THE REPORTER'S ASSSSMENT OF THE PT'S VIABILITY AND THE AVAILABILITY OF A BACK UP DEVICE.
DEVICE OPERATION WAS REVIEWED WITH THE FACILITY. SECTION A. SEVERAL UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO ACQUIRE PT INFO FROM THE USER FACILITY. CODE #2199-LABELING NA. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
A RECENT TELEPHONIC STUDY OF THE PACEMAKER SUGGESTED A LOST CAPTURE OF THE VENTRICULAR ELECTRODE. THE PT WAS SEEN IN THE PHYSICIAN'S OFFICE ON 2/19/96. THE PACEMAKER WAS INTERROGATED, REVEALING THAT THE PT WAS NOT PACEMAKER DEPENDENT. A VENTRICULAR ELECTRODE FRACTURE WAS SUSPECTED WITH LEAD IMPEDENCE LESS THAN 250 OHMS AND PULSE CURRENT OF 19.2 MILLIAMPERES, ATRIAL LEAD WAS SATISFACTORY. PACING WAS CHANGED TO AA1 FROM DDI TO PROVIDE LEAD PROTECTION UNTIL 2/20/96 WHEN THE PT WAS ADMITTED FOR LEAD REPLACEMENT SURGERY. THE LEAD WAS CAPPED AND EXCLUDED DURING THE SURGICAL PROCEDURE. THE PT HAS A HISTORY OF SICK SINUS SYNDROME WITH PACEMAKER INSERTION ON 2/16/89.
THE RPTR INDICATED THAT THE PT HAD NECK SURGERY AND BEFORE SURGERY THE DEVICE WAS PROGRAMMED TO THE AOO MODE. AFTER SURGERY, THE DEVICE WAS EXHIBITING ABNORMAL BEHAVIOR AND PROGRAMMER DISPLAYED THE BACKUP RESET MESSAGE UPON INQUIRE. WHEN ATTEMPTING PERFORM A BACKUP RESET, THE RPTR CONSISTENTLY GOT "COMMUNICATIONS LOST" MESSAGE. BOVIE WAS USED DURING NECK SURGERY.
HOPS PERSONNEL ATTENDED TO A POST OPERATIVE KIDNEY TRANSPLANT PT IN CARDIAC ARREST. THE DEFIBRILLATOR WOULD NOT DISCHARGE WHEN DEFIBRILLATION ATTEMPTS WERE MADE. ANOTHER DEFIBRILLATOR WAS IMMEDIATELY USED AND THE PT WAS CONVERTED. THE PT EXPIRED THE FOLLOWING DAY DUE TO MULTIPLE COMPLICATIONS. THE REPORTER INDICATED THE DEVICE MALFUNCTIONED DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THE STATEMENT WAS BASED UPON THE LACK OF PT VIABILITY AND THE AVAILABILITY OF ANOTHER DEFIBRILLATOR DURING THE CODE.
CO EVALUATED THE DEVICE AND OBSERVED A SIMILAR MALFUNCTION. THE STERNUM PADDLE DISCHARGE SWITCH WAS OBSERVED TO HAVE FAILED. THE SWITCH WAS REPLACED, THE UNIT WAS TESTED THEN RETURNED TO THE CUSTOMER FOR USE.
BLOOD NOTED IN TUBING AFTER AN UNDETERMINED TIME OF USE. THE PERFUSIONIST WAS UNABLE TO PROVIDE ANY ADD'L DETAILS SURROUNDING THE EVENT.
H-11-ALL UNK INFO REQUESTED NOT RECEIVED. H-11-SECTION F PROVIDED BY MFR. H-11-SECTION F10 DEVICE CODE 1746 LABEL.
THE DEVICE WAS IMPLANTED WITH ANOTHER LEAD (4512-53-0001794V) ON 5/27/04. WHEN DOING A FOLLOW-UP CHECK ON 10/4/96, OVERSENSING AND PACING FAILURE WERE OBSERVED, AND DR DECIDED TO REPLACE BOTH THE PACER AND LEAD. AFTER EXPLANT, THE DR DECICDED THAT THE CAUSE OF THE FAILURE WAS DUE TO THE DAMAGE OF THE INNER LEAD INSULAITON, BUT HE REQUESTED ANALYSIS ON PACER.
THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING AND ENVIROMENTSAL STRESS TESTING, AND CONNECTOR DIMINSIONAL ANALYSIS. NORMAL PACER OPERATION WAS OBSERVED. THE UNIT OPERATING WITHIN NEW PACER SPECIFICATIONS.
IT WAS REPORTED THE DEVICE WAS USED DURING A V.A.T.S PROCEDURE. IT WAS REPORTED BY THE REP ON THE FIRST FIRING, TISSUE WAS NOT CUT COMPLETELY. FROM THE THIRD FIRING THE INSTRUMENT DID NTO CUT AND STAPLE THE TISSUE. THE CASE WAS FINISHED WITH OVERSEW AND ENDOLOOP. THERE WAS NO CONSEQUENCE TO THE PT.
THE DEVICE WAS REMOVED DUE TO SKIN EROSION AT THE PACEMAKER POCKET.
HOSPITAL PERSONNEL WERE ATTEMPTING TO EXTERNALLY PACE A BRADYCARDIAC PT WHO HAD BEEN SHOCKED 96 TIMES. ALLEGEDLY THE OPERATOR INCREASED THE CURRENT AND COULD NOT GET CAPTURE. REPORTEDLY THE PT BECAME ASYSTOLIC AND WAS MOVED TO ANOTHER AREA FOR TREATMENT. THE REPORTER STATED THERE WERE NO ADVERSE EFFECTS TO THE PT AS A RESULT OF A MALFUNCTION.
AN OFFER TO HAVE CO EXAMINE THE DEVICE WAS DECLINED. THE DEVICE WAS EVALUATED BY THE HOSPITAL'S BIOMEDICAL ENGINEERING, OBSERVED TO FUNCTION PROPERLY AND RETURNED TO USE. SECTION A ALL PT INFO PROVIDED BY THE REPORTER IS INCLUDED IN THIS REPORT. CODE #2199-LABELING NA EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
A URETER STONE LITHOTRIPSY PROCEDURE WAS BEING DONE WHEN THE DISTAL METAL TIP OF THE ELECTROHYDRAULIC LITHOTRIPSY (EHL PROBE) SPLIT. TWO OTHER EHL PROBES WERE TRIED AND THE METAL TIPS AGAIN SPLIT. THE CASE WAS COMPLETED WITH ANOTHER PROBE. NO PT PROBLEMS OCCURRED.
DATA SHOWN IN SECTION F WAS FILLED IN BY THIS MFR. EVAL SUMMARY: THREE (3) OF THE DEVICES WERE RECEIVED AND EVALUATED. EACH PROBE HAD ONE OR MORE SPLITS IN THE METAL BUSHING OF THE DISTAL TIP. IT WAS NOTED, HOWEVER, THAT ALL OF THE PROBES WERE ABLE TO FIRE AN ADEQUATE DISCHARGE WHEN POWER WAS APPLIED. THIS FINDING INDICATES THAT THE USER MAY HAVE TEST FIRED THE PROBES IN AIR OR IN PLAIN WATER, WHICH WOULD CAUSE RAPID HEAT UP AND FRACTURING OF THE METAL. USER WILL BE ADVISED THAT NORMAL SALINE SHOULD BE USED FOR THEIS PROCEDURE.
A PT'S SERUM SAMPLE WAS RUN MULTIPLE TIMES USING THE ASSAY. ALL RESULTS WERE ELEVATED. RESULTS USING ANOTHER METHOD WERE NOT ELEVATED. THERE WAS NO CLINICAL EVIDENCE OF COLON CANCER ACCORDING TO HE PHYSICIAN HOWEVER, THE ADD'L TESTING WAS PERFORMED DUE TO A FAMILY HISTORY OF COLON CANCER. THE 8/7 SPECIMEN WAS RETURNED FOR EVALUATION. NO KIT WAS RETURNED. THE RETURNED SERUM SAMPLE WAS TESTED NEAT AND AFTER BEING SPIKED WITH A HETEROPHILE BLOCKING REAGENT (HBR) USING AN IN-HOUSE KIT, LOT NUMBER 690287. RESULTS WERE AS FOLLOWS: NEAT =7.1 MG/ML. NEAT + HBR =< MDC (MINIMUM DETACTABLE CONCENTRATION). BASED ON THE ABOVE RESULTS, THE DATA INDICATES THAT THERE IS AN INTERFERING SUBSTANCE IN THE PT'S SERUM SAMPLE WHICH CAUSED A FALSELY ELEVATED RESULT WHEN USING THE ASSAY KIT LOT NIUMBER 690287.
THE SUBMISSION OF THIS MEDICAL DEVICE REPORT IS REQUIRED OF DEVICE MFRS BY 21 CFR PAR 803. NEITHER THE SUBMISSION OF INFO BY US PURSUANT TO THIS RULE, NOR THE PUBLIC RELEASE OF SUCH INFO CONSTITUTES AN ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR ESTABLISHES THE EXISTENCE OF ANY CONNECTION BETWEEN THE PRODUCT AND ANY DEATH OR INJURY.
THE DEVICE BLANKED MOMENTARILY SEVERAL TIMES WHILE MONITORING A PT. THE CUSTOMER ALSO COMPLAINED THAT THE DEVICE'S CRT DISPLAY HEART RATE DIGITS WERE DISTORTED AND MISSING PIXELS. A BACKUP MONITOR WAS CALLED FOR AND USED. NO ADVERSE AFFECTS TO THE PT WERE REPORTED AS A RESULT OF THE REPORTED MALFUNCTION.
IN EVAL OF THE DEVICE, CO OBSERVED THE DEVICE'S CRT, STRIP CHART RECORDER AND ECG OUT DISPLAY A FLATLINE WITH AN NSR INPUT. THE ECG PCB ASSEMBLY WAS REPLACED, A COMPLETE FUNCTIONAL TEST PERFORMED, PROPER OPERATION OBSERVED AND THE DEVICE RETURNED TO THE FACILITY FOR USE.
DURING THE PLACEMENT OF AN INTRAOCCULAR LENS INTO THE EYE, THE LENS BROKE. THE INCISION HAD TO BE MADE LARGER TO REMOVE THE BROKEN LENS.
THE RPTR INDICATED THAT A TOTAL LOSS OF VENTRICULAR SENSING WAS OBSERVED. THE CO SALE REP WAS NOTIFIED, BUT NO FURTHER INFO COULD BE OBTAINED.
DURING USE OF A STAPLER FOR THE CLOSURE OF AN INCISION, THE STAPLERS WERE NOTED NOT TO CLOSE COMPLETELY. SEVERAL STAPLES THAT HAD BEEN USED TO CLOSE THE WOUND COULD BE EASILY REMOVED. THE REMAINDER OF THE OPEN WOUND AND THE AREA ALREADY STAPLED WERE THEN SUTURED.
AS THE DR APPLIED A FALLOPIAN TUBE CLIP DURING A LAPAROSCOPIC TUBAL STERILIZATION PROCEDURE, A SMALL AMOUNT OF SPACE WAS SEEN BETWEEN THE METAL SPRING AND THE PLASTIC JAWS. A SECOND CLIP WAS APPLIED TO THE TUBE USING ANOTHER APPLICATOR. NO PT PROBLEMS WERE REPORTED.
DATA SHOWN IN SECTION F WAS FILLED IN BY THIS U.S. AGENT OF THE MFR.
DISTRIBUTOR REPORTED RECEIVING A CUSTOM KIT IN AN INADEQUATELY SEALED POUCH. THE KIT WAS NOT USED.
EXAMINATION OF THE RETURNED POUCH REVEALED THAT THE POUCH APPEARED TO HAVE BEEN CUT THROUGH THE PEAK OF THE CHEVRON SEAL. AS THIS MOST LIKELY WOULD HAVE HAPPENED DURING MANUFACTURING OF THE POUCH, THE POUCH VENDOR HAS BEEN NOTIFIED. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE INFO CONTAINED HEREIN IS BEING PROVIDED TO FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF NAMIC USA CORP. THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANYWAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAP OOPHERECTOMY. IT WAS REPORTED THE EZ35W WOULD NOT RELEASE FROM TISSUE AFTER FIRING. THE INSTRUMENT HAD MADE A LOUD CRACKING SOUND WHEN FIRED. A GRASPER WAS USED TO RELEASE THE DEVICE FROM TISSUE. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION: RECORD PURPOSES ONLY: NO ANALYSIS COULD BE PERFORMED SINCE NO INSTRUMENT WAS RECEIVED. THE INFO YOU PROVIDED HAS BEEN NOTED AND REVIEWED WITH THE APPROPRIATE MFG AND ENGINEERING PERSONNEL.
PT HAD CATHETER IMPLANTED IN 9/95. IN 3/96, THE CATHETER WAS FOUND TO BE FRACTURED VIA ANGIOGRAM. A 9CM SEGMENT OF THE CATHETER WAS NOTED TO BE IN THE PULMONARY ARTERY AND REMAINS IN THE PULMONARY ARTERY. REMAINING PORTION OF CATHETER REMOVED.
PARAMEDICS WERE ATTENDING TO A PT IN FULL CARDIAC ARREST. ALLEGEDLY AFTER HOOKING THE PT UP, THE CRT WENT BLANK AND WOULD NOT DISPLAY THE PT'S RHYTHM. A BACK UP DEVICE ARRIVED AND WAS USED TO CONTINUE TREATMENT. THE PT WAS NOT RESUSCITATED. THE REPORTER STATED THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THIS OPINION WAS BASED ON THE REPORTER'S ASSESSMENT OF THE PT'S VIABILITY AND THE AVAILABILTY OF A BACK UP DEVICE.
THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. SECTION A ALL PT INFO PROVIDED BY REPORTER IS INCLUDED IN THIS REPORT. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
AN ENGINEERING INVESTIGATION WAS INITIATED ON REPORTS OF THE POSSIBILITY OF THE DEVICE CARRYING CASE CENTER STRAP TO PRESS ON THE DEFIBRILLATOR LATCH. IF THIS OCCURS AND THE MONITOR AND DEFIBRILLATOR SEPARATE, THE RESULT COULD BE AN INTERMITTENT CONNECTION BETWEEN THE MONITOR AND DEFIBRILATOR, POSSIBLY CAUSING INTEMITTENT OPERATION OF THE PACING AND SYNCHRONIZATION FUNCTIONS.
THE INVESTIGATION BY PHYSIO-CONTROL CONCLUDED THAT WIDESPREAD REMEDIAL CORRECTIVE ACTION WAS NOT WARRANTED. FIELD EXPERIENCE INDICATES THERE HAS BEEN A LOW RATE OF OCCURRENCE OF THE REPORTED MALFUNCTION. DIFFERENT CONFIGURATIONS OF THE CARRYING CASE WERE DESIGNED TO ACCOMMODATE USE WITH FOLLOWING COMBINATIONS OF DEVICES: LIFEPAK 11 DIAGNOSTIC CARDIAC MONITOR WITH LIFEPAK 11 DEFIBRILLATOR/PACEMAKER AND THE LIFEPAK 11 DIAGNOSTIC CARDIAC MONITOR WITH LIFEPAK 5 DEFIBRILLATOR. FAILURES ARE POSSIBLE IF THE CUSTOMER USES THE INCORRECT CARRYING CASE. LABELS HAVE BEEN ADDED TO NEW CARRYING CASES TO INDICATE THE CORRECT DEVICE ON WHICH IT IS TO BE USED. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
58 YEAR MALE UNDERWENT A RADICAL RETROPUBIC PROSTATECTOMY ON 08/20/96. WHILE SURGEON WAS USING DEVICE, THE DEVICE MISFIRED CAUSING CLIP TIPS TO OVERLAP INSTEAD OF MEETING TOGETHER. THIS CAUSED THE CLIPS NOT TO HOLD. NO ADVERSE OUTCOME WAS NOTED.
IT WAS REPORTED THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIPS DID NOT FORM PROPERLY. THE CASE WAS FINISHED BY OPENING ANOTHER ER320. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6:H4: INFORMATION UNAVAILABLE.H6: CODE 400(OTHER): YEILDED JAWS.
AT THE INITIATION OF A ROUTINE PHACOEMULSIFICATION PROCEDURE, THE DR DETECTED A METAL FLAKE ENTERING THE EYE. THE HANDPIECE WAS REMOVED AND PLACED INTO A TEST CHAMBER WHERE IT WAS IRRIGATED. A SECOND FLAKE WAS NOTICED FLOWING FROM THE TIP. THE TIP WAS REPLACED AND THE CASE WAS CONTINUED WITHOUT FURTHER INCIDENT.
H3: EVALUATION SUMMARY: METALLURGICAL ANALYSIS WAS PERFORMED ON A FRAGMENT THAT WAS RETURNED ALONG WITH THE ULTRASONIC PHACO NEEDLE. THE RESULTS OF THE ANALYSIS REVEALED THAT THE PARTICLE WAS COMPOSED OF TITANIUM. THE EXACT ORIGIN OF THE PARTICLE IS UNK.
DURING THE INSERTION OF JUGULAR VENA CAVA FILTER, THE GUIDE WIRE WOULD NOT COME UP OUT OF THE LAUNCHED FILTER. THE GUIDE WIRE COILED AND WEDGED UNDER THE STRUT OF THE FILTER. ATTEMPTS WERE MADE TO DISLODGE THE WIRE BUT THE FILTER MOVED AND LODGED IN RIGHT RENAL VEIN. THE INTRODUCER UNIT AND SHEATH WERE REMOVED AND THE SPUN EXTERNAL CORE WIRE WAS LEFT IN PLACE AND BROUGHT UP THROUGH THE PURSE STRING OUT TO THE EXTERNAL ENVIRONMENT. IT WAS TIED IN A LARGE KNOT AND PLACED UNDERNEATH THE RIGHT STERNOCLEIDOMASTOID MUSCLE. A SECOND VENA CAVA FILTER WAS THEN PLACED.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED TOTAL VAGINAL HYSTERECTOMY. IT WAS REPORTED THE EZ35W WAS LOADED WITH A BLUE CARTRIDGE PRIOR TO FIRING. THE CARTRIDGE FELL OUT OF THE INSTRUMENT, AND THE RED TAB THAT FACILITATES THE CARTRIDGE LOADING BROKE. BOTH THE CARTRIDGE AND THE RED TAB WERE RETRIEVED. A SECOND EZ35W WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
THE RPTR INDICATED THAT INTERMITTENT LOSS OF ATRIAL SENSING WAS OBSERVED. THE CO REP WAS NOTIFIED, BUT NO FURTHER INFO COULD BE OBTAINED.
THE RPTR INDICATED THAT A LOSS OF ATRIAL CAPTURE WAS OBSERVED. THE CO REP WAS NOTIFIED, BUT NO FURTHER INFO COULD BE OBTAINED.
CUSTOMER CLAIMS UNITS HAVE FOLDED WHEN UNLOADED FROM VEHICLE WITH WEIGHT. NO INJURIES HAVE BEEN REPORTED.
PER AN INDEPENDENT SERVICE AGENT, THE END USER CANCELLED THE SERVICE CALL. PROBLEM WAS DUE TO OPERATOR ERROR.
IT WAS REPORTED THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIPS DID NOT FORM PROPERLY. REP RETURNING CLIP WITH INSTRUMENT WHICH WAS PULLED FROM ABDOMEN. THE INSTRUMENT WAS FROM A PROCEDURE TRAY, LOT NUMBER J44C82. THERE WAS NO CONSEQUENCE TO THE PT.
IT WAS REPORTED THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED WHEN THE CLIP APPLIER WAS FIRED, THE TIPS CROSSED AT TIP. IT IS NOT KNOWN IF CLIPS WERE DEEMED SATISFACTORY OR IF ANOTHER INSTRUMENT WAS NEEDED TO FINISH PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.
H6: CODE 400(OTHER): MISALIGNED JAW TIPS.H4; D5: INFORMATION UNAVAILABLE
THE RPTR INDICATED THAT THE PACER WOULD NOT SECURE THE LEADS. IT WAS REMOVED AND WILL BE RETURNED.
REF F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE TWO LEADS WERE NOT CO'S LEADS.
CUFF ALLEGEDLY DEFLATED, ATTEMPTS TO REINFLATE WERE UNSUCESSFUL.
DATA TO DETERMINE LABELED OR USUAL RATES OF OCCURRENCE OR SEVERITY IS EITHER UNK OR UNAVAILABLE. DEVICE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
WHILE INVESTIGATING AN OBSTETRICAL CALCULATIONS REPORT, THE REPORTER FOUND THAT A DIGIT HAD BEEN OMITTED WHEN COMPARED TO THE DATA SAVED IN THE ULTRASOUND SYSTEM. THE DIGIT WAS OMITTED DURING TRANSMISSION OF THE ULTRASOUND DATA TO CO'S IMAGE AND DATA ACQUISITION SYSTEM. ENGINEERING TESTING HAS CONFIRMED THAT THE PROLEM OCCURS INFREQUENTLY. THIS MEASUREMENT CAN BE USED IN DETERMINING FETAL WEIGHT AND GESTATIONAL AGE. BASED ON CONSULTATION WITH A PERINATOLOGIST, CO BELIEVES THE CHANCE OF SERIOUS INJURY IS REMOTE.
ENGINEERING DEPT CONTINUES TO INVESTIGATE THIS PROBLEM TO DETERMNE ITS ROOT CAUSE AND IDENTIFY CORRECTIVE ACTION. THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY OR DEATHS TO DATE. CO DOES NOT BELIEVE THAT IT IS LIKELY THAT A DEATH OR SERIOUS INJURY WILL OCCUR AS DEFINED IN THE FDA REGULATIONS. HOWEVER, TO BE CONSERVATIVE, CO DECIDED IN THE SPIRIT OF THE MDR REGULATIONS TO REPORT THIS MALFUNCTION. CUSTOMERS WILL BE NOTIFIED BY LETTER PENDING AVAILABILITY OF A SYSTEM UPGRADE THAT CORRECTS THE PROBLEM.
IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP STAPLES WOULD NOT HOLD IN THE INSTRUMENT ON THE CARTRIDGE. THERE WAS NO CONSEQUENCE TO THE PT.
THE DEVICE WAS GETTING FALSE TELEMETRY VALUES.
NO INVESTIGATION POSSIBLE WITHOUT THE RETURN OF THE DEVICE.
1ST IAB WAS INSERTED 10/23/96 AT 2PM POST COR. BYPASS 4.5 HRS LATER BLOOD WAS NOTED IN TUBING, PUMP ALARM W/HIGH GAS LEAKAGE. PT RETURNED TO OR AT 6.5PM FOR REMOVAL AND REPLACEMENT. THE PUMP ALARMED OVER THE NEXT 18 HRS ALARMS WERE THEN SHUT OFF. AT 1PM BLOOD NOTED IN TUBING IAB REMOVED, NO FURTHER THERAPY WAS NEEDED BOTH IABS RETURNING.
H-11-ALL UNK INFO REQUESTED BUT NOT REC H-11-SECTION F PROVIDED BY MFR H-11-SECTION F10 DEVICE CODE 1746 LABEL.
PRIOR TO IMPLANT, THE DEVICE COULD NOT BE INQUIRED. THERE WAS NO PT INVOLVED.
THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING AND ENVIRONMENTAL STRESS TESTING. NORMAL PACER OPERATION WAS OBSERVED. THE UNIT IS OPERATING WITHIN NEW PACER SPECIFICATIONS.
HOSP PERSONNEL REPORT THAT THE INJECTOR FLOW RATE DELIVERED CONTRAST FASTER THAN SELECTED. NO INJURY OCCURRED.
SERVICE CHECK OUT AND EVALUATION WAS ABLE TO CONFIRM THE FASTER TGHAN SELECTED FLOW RATE. THE SERVO CONTROL CARD (SCC) WAS REMOVED AND RETURNED FOR EVALUATION. TESTING IS BEING PERFORMED ON THE SCC; NO TROUBLE WAS FOUND. TESTING CONTINUES ON THE SCC. NO FURTHER REPORTS FROM THE USER. DURING EVALUATION, UNIT SET AT 1ML/SEC APPEARED TO DELIVER AT 3ML/SEC. 3ML/SEC UNIT APPEARED TO INJECT AT 05-06ML/SEC.
IT WAS REPORTED THE INSTRUMENT BROKE. THE CO WAS CONTACTED, THE PURCHASING SECRETARY. 10/22/96 THE EMS WAS USED DURING A LAPAROSCOPIC BURCH REPAIR. THE STAPLE WAS JAMMING IN THE DEVICE. ANOTHER EMS WAS OPENED TO COMPLETE THE CASE AND WORKED FINE. THERE WAS NO CONSEQUENCE TO THE PT.
AMBULANCE PERSONNEL WERE ATTENDING TO A PT DIAGNOSED TO BE IN VENTRICULAR FIBRILLATION. ALLEGEDLY THE DEVICE WOULD NOT TRANSFER ENERGY. PT OUTCOME UNK.
SECTION A AND B. SEVERAL ATTEMPTS AT ACQUIRING PT INFO AND EVENT DESCRIPTION HAVE BEEN MADE WITH NO RESPONSE FROM THE USER FACILITY. CODE #2202 LABELING NA EXCEPT. AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
THE PACER PROGRAMS IMPROPERLY, AND THERE IS NO TELEMETRY. THERE WAS NO PT INVOLVED.
REF F.10 OF THIS FORM FOR THE EVENT PROBLEM CODES. THE OBSERVED IMPROPER PROGRAMMING WAS THE RESULT OF A MALFUNCTION IN THE "ALU" PORTION OF THE OMEGA IC DUE TO HIGH RESISTANCE IN A CONTACT WINDOW.
DURING LAPAROSOCPIC BURCH PROCEDURE DEVICE MALFUNCTIONED, NEEDLE BROKE IN HALF IN PELVIC AREA ABOUT 2 CM IN LENGTH. SUCTION FLUID STRAINED, NEEDLE NOT FOUND. X-RAY TAKEN IN PACU. NEEDLE WAS RETAINED IN PT. NO PROBLEM WITH WHERE IT IS LOCATED IN PT. MD SPOKE WITH PT AND PT'S HUSBAND. NEEDLE PIECE WAS VERY SMALL. EXPIRATION DATE: 1/2001.
THE LIGHT SEPARATED FROM THE CEILING ATTACHMENT AND FELL TO THE FLOOR.
DEVICE EVALUATION WAS BASED ON SIMILAR FAILURE FROM A LATER COMPLAINT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT. THE SURGEON APPLIED ANOTHER INSTRUMENT AND CONTINUED THE PROCEDURE WITHOUT INCIDENT.
WHILE LOWERING A RESIDENT THE HOIST CONTINUED TO LOWER EVEN THOUGH THE HANDSET HAD BEEN RELEASED. THE NURSE MANUALLY RESTRAINED THE BOOM SO THAT THE RESIDENT WAS NOT CRUSHED. SINCE THEN THE HOIST WILL NOT GO UP OR DOWN.
INITIAL REPORT BY FOREIGN REPORTER, FOREIGN REPORTER HAS ASSIGNED AN INVESTIGATOR TO INCIDENT AND IS TO FORWARD CLOSING OUT REPORT ON FINDINGS.
PT FALL. PT AMBULATING FROM BATHROOM TO WHEELCHAIR WITH THE USE OF A WALKER. PT ATTEMPTED TO PIVOT INTO A LOCKED WHEELCHAIR AND SIT. WHEELCHAIR ROLLED AWAY FROM THE PT. THE PT FELL TO THE FLOOR HITTING HER HEAD AND COCCYX. THE PT COMPLAINED OF HEADACHE. NO BROKEN SKIN WAS NOTED AND THE PT WAS TRANSPORTED TO THE ER, AT THE LOCAL HOSP FOR EVALUATION AND TREATMENT, BY AMBULANCE. THE WHEELCHAIR LOCK WAS IN THE LOCKED POSITION AT THE TIME OF THE INCIDENT. THE LOCKING MECHANISM APPARENTLY MALFUNCTIONED DURING THE TRANSFER PROCEDURE. A LOOSE SCREW WAS FOUND ON THE FLOOR OF THE BATHROMM AFTER THE BRAKE MALFUNCTIONED AND WAS REPLACED IN THE WHEELCHAIR BY FAMILY MEMBER.
THIS INFO WAS REPORTED TO A CO CLINICAL EDUCATION SPECIALIST AS A CUSTOMER COMPLAINT. PRODUCT WAS USED IN THE RCFA FOLLOWING A DIAGNOSTIC CATHERIZATION PROCEDURE. THE OPERATOR EXPERIENCED RESISTANCE WHILE ATTEMPTING TO DEPLOY THE FIRST PLUG. THE PRODUCT SHEATH WAS REPOSITIONED AND THE PROCEDURE WAS CONTINUED. FOLLOWING ATTEMPTED DEPLOYMENT OF BOTH COLLAGEN PLUGS, THE SHEATH HUB ASSEMBLY WAS REMOVED AND A TEAR WAS NOTED IN THE SIDE OF THE PRODUCT SHEATH. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION WITH NO CLINICAL COMPLICATIONS TO THE PT. CO EVALUATION OF THE RETURNED PRODUCT SHOWED A LARGE TEAR IN THE SIDE OF THE PRODUCT SHEATH. THE PLUNGER WAS PROTRUDING THROUGH THE TEAR AND ONE COLLAGEN PLUG REMAINED IN THE PRODUCT SHEATH. CODE 86: A REVIEW OF THE MANUFACTURING AND QC RECORDS FOR THIS LOT OF PRODUCT SHOWED NO DEVIATIONS FROM SPECIFICATION. CODE 68: A REVIEW OF THE MANUFACTURING AND QC RECORDS FOR THIS LOT OF PRODUCT SHOWED NO DEVIATIONS FROM SPECIFICATION. CODE 68: THE PRODUCT SHEATH IS DESIGNED TO DELIVER COLLAGEN THROUGH AN UNRESTRICTED PASSAGE. REPOSITIONING OF THE SHEATH CAN CAUSE TORQUE ON THE SHEATH WHICH CAN DAMAGE THE SHEATH AND RESTRICT THE PASSAGE OF COLLAGEN. CONTINUED ATTEMPTS TO DELIVER THE COLLAGEN CAN FORCE THE PLUNGER THROUGH THE SIDE WALL OF THE SHEATH. THE IFU STATES THAT IF EXCESSIVE RESISTANCE IS EXPERIENCED, WHILE DELIVERING THE COLLAGEN PLUGS, DISCONTINUE THE PRODUCT PROCEDURE.
SEAT BECAME DETACHED FROM HOIST DURING USE. NO INJURY TO RESIDENT OR STAFF. NO FURTHER INFO AVAILABLE.
INVESTIGATION: THE CHAIR PICK UP HOOK HAS BEEN BENT FORWARD ALLOWING THE CHAIR TO BE REMOVED FROM THE HOOK EVEN WHEN THE JIB SAFETY CATCH IS IN THE CLOSED POSITION. CONCLUSIONS: THIS INCIDENT WAS CAUSED BY USER ERROR AS THE PICK UP HOOK WAS BENT ALLOWING THE CHAIR TO BE REMOVED WHILE THE CATCH IS CLOSED. CORRECTIVE ACTION: A NEW JIB WAS FITTED TO THE MACHINE ON 8/11/96.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE INSTRUMENT EJECTED CLIPS PREMATURELY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP REPORTED THAT NO PT INJURY OCCURRED.
A LOSS OF VENTICULAR SENSING WAS OBSERVED.
IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP STAPLES WOULD NOT HOLD IN THE INSTRUMENT, OR IN THE CARTRIDGE. THERE WAS NO CONSEQUENCE TO THE PT.
BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS  LOADED WITH A RELOAD CARTRIDGE AND WAS LOADED AND UNLOADED SEVERAL TIMES WITH NO DIFFICULTIES NOTED OF THE STAPLES FALLING OUT. THE INSTRUMENT WAS THEN FIRED AND FIRED AND FORMED STAPLES AS DESIGNED ACORSS THE ENTIRE STAPLE LINE. THERE WERE NO DIFFICULTIES NOTED WITH THE STAPLES FALLING OUT OF THE CARTRIDGE OR THE INSTRUMENT PERFORMING AS DESIGNED. IT SHOULD BE NOTED THAT WHILE RELOADING THE INSTRUMENT, THE SAFETY MUST BE IN THE LOCKED POSITION. THIS WILL PREVENT AN INADVERTENT MOVEMENT OF THAT FIRING TRIGGER CAUSING THE STAPLES TO FALL OUT. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
DURING A PLANNED MAINTENANCE VISIT, CO SERVICE REP NOTED OUTPUT WAS NOT WITHIN SPECIFICATION. THERE WAS NO REPORTED PT INJURY. CO'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
INVESTIGATION/CONCLUSION: THE UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED, THE CAUSE OF WHICH WAS THE ROTARY VALVE. OHMEDA HAS TAKEN SEVERAL ACTIONS TO ADDRESS PERFORMANCE ISSUES ASSOCIATED WITH THE ROTARY VALVE OF THE TEC 6 VAPORIZER. AS A RESULT, THE FREQUENCY OF OCCURRENCE OF THESE ISSUES HAS DROPPED TO 0.2% OF THE INSTALLED U.S. BASE IN FISCAL YEAR 1996 FROM 0.4% IN 1994. OHMEDA WILL CONTINUE TO MONITOR  THESE REPORTS AND EVALUATE THE APPROPRIATENESS OF OTHER MATERIAL AND/OR PROCESS MODIFICATIONS.
AT INITIAL STIMULATION OF THE IMPLANT, THE PT REPORTED PRIMARILY NON-AUDITORY SENSATIONS. AN X-RAY CONFIRMED THE ELECTRODE ARRAY WAS NOT IN THE COCHLEA. AN X-RAY HAD NOT BEEN DONE IMMEDIATELY POST-SURGERY BUT THE SURGEON STATED THAT THE ARRAY HAD BEEN IN THE COCHLEA AND MUST HAVE MIGRATED. DURING THE SECOND SURGERY, THE SURGEON DISCOVERED THE ELECTRODE ARRAY WAS CORRECTLY PLACED IN THE COCHLEA. WHILE EXAMINING THE ARRAY, THE SURGEON CRUSHED ONE OF THE STIFFENING RINGS. HE THEREFORE REPLACED THE IMPLANT. AFTER THE SURGERY, IT WAS REPORTED THAT THE X-RAY WAS "UNCLEAR." THIS EVENT OCCURRED OUTSIDE OF THE US.
WHEN LIFTING PERSON FROM FLOOR, KEY HOLE BUTTON BY SHOULDER POPPED OFF. PERSON FELL PARTIALLY OUT OF SLING AND STAFF GRABBED SLING. SLING USED AS A MAA4000M.
UPON INSPECTION DEVICE WAS FOUND TO BE IN PROPER WORKING CONDITION. CAUSE OF EVENT WAS USER ERROR. WEIGHT OF PT KEEPS PIN IN SLOT, UNLESS CANDIDATE IS IMPROPER OR CLIP IS NOT SECURED. MAINTENANCE MANUAL STATES: "ENSURE THE SLING CLIP ENGAGES FULLY INTO POSITION BEFORE ATTEMPTING TO LIFT A PT." CUSTOMER HAS BEEN INSTRUCTED TO REVIEW THE MAINTENANCE MANUAL FOR PROPER TECHNIQUE AND USE, IF THE CUSTOMER DOES NOT HAVE THE MANUAL THEY ARE TO REQUEST ONE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
CUSTOMER REPORTED LOW OUTPUT. THERE WAS NO REPORTED PT INJURY. CO'S INVESTIGATION INTO THE REPORTED EVENT IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
IT WAS REPORTED THE DEVICE WAS USED DURING A UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP THE FIRE CYCLE SUCCESSFULLY COMPLETED AFTER REMOVAL OF CDH29 SURGEON NOTICED A HOLE APPROXIMATE IN ANASTOMOSIS. INSPECTIONS OF DONUTS RESULTED IN AND SMALL PROXIMATE DONUT AND 2 VERY THICK DONUTS (APPROX 1 CM DISTANCE BETWEEN EACH OTHER). THERE WAS NO CONSEQUENCE TO THE PT.
BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RELOADED AND FIRED. DESPITE SOME VISIBLE TO THE KNIFE, THE TEST MEDIA WAS COMPLETELY CUT AROUND THE ENTIRE CIRCUMFERENCE. THE INSTRUMENT FIRED AND FORMED STAPLES AS DESIGNED AROUND THE ENTIRE STAPLE RING WITH NO DIFFICULTIES NOTED. AS IT WAS REPORTED THAT THERE WERE MORE THAN TWO DONUTS PRESENT, THE FIRING TRIGGER MAY HAVE BEEN FIRED MORE THAN ONCE WHICH MAY HAVE CAUSED THE KNIFE TO CUT THROUGH THE TISSUE AND CREATE THE HOLE. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.
IT WAS REPORTED THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP JAMMED. THERE WAS NO CONSEQUENCE TO THE PT.
H6; CODE 100: THE INSTRUMENT WAS RECEIVED WITH A BROKEN ROTATING HEAD HOUSING WELD, WHICH WAS TO HAVE BEEN SUFFICIENTLY WELDED. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "JAMMED" DURING SURGERY MAY HAVE BEEN DUE TO A YIELDED ROTATING HEAD HOUSING WELD. THE INSTRUMENT WAS RECEIVED WITH A YIELDED ROTATING HEAD HOUSING WELD. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO A YIELDED ROTATING HEAD HOUSING WELD. THE WELD WAS EXAMINED AND WAS FOUND TO HAVE BEEN SUFFICIENTLY WELDED. THE CARTRIDGE DRIVER WAS MANUALLY CYCLED AND THE INSTRUMENT FED, FIRED AND PROPERLY FORMED THE REMAINING 7 STAPLES. NO CONCLUSION COULD BE REACHED AS TO HOW THE ROTATING HEAD HOUSING WELD HAD YIELDED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. THE INSTRUMENT?S ROTATING HEAD HOUSING WELD MAY BECOME COMPROMISED IF EXCESSIVE PRESSURE IS APPLIED AT THE DISTAL END OF THE INSTRUMENT DURING FIRING.
CLIP BROKE ON EXTRA LARGE SLING. NO INJURY.
SLING WAS RETURNED TO CO ON 10/23/96. UPON RETURN IT WAS DISCOVERED THAT THE SLING WAS RETURNED WITHOUT THE LIP. COULD NOT INVESTIGATE SLING. THIS HAS BEEN ADDRESSED BY MFG WORK ORDER NUMBER 012119, EXTENSIVE TESTING COMPLETED. THIS WAS AN ISOLATED INCIDENT AND THERE WERE NO INJURIES INVOLVED.
THE PT DEVELOPED OTITIS MEDIA AT SOME TIME POST IMPLANT SURGERY. OUTPATIENT ANTIBIOTIC THERAPY WAS NOT SUCCESSFUL. ON 9/25/96 THE PT WAS ADMITTED TO THE HOSP FOR IV ANTIBIOTIC TREATMENT FOR A MIDDLE EAR AND MASTOID INFECTION. STAPH WAS CULTURED. THE INFECTION REOCCURRED AND THE PT UNDERWENT DEVICE EXPLANTATION AND A MODIFIED RADICAL MASTOIDECTOMY ON 10/30/96.
11/13/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPROT TO FDA BY MFG.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED.
11/15/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
A 58 YEAR OLD MALE UNDERWENT A RADICAL RETROPUBIC PROSTATECTOMY ON 8/20/96. WHILE SURGEON WAS USING AUTOMATIC CLIP APPLIER, THE DEVICE MISFIRED CAUSING CLIP TIPS TO OVERLAP INSTEAD OF MEETING TOGETHER. THIS CAUSED THE CLIPS NOT TO HOLD. NO ADVERSE OUTCOME WAS NOTED.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THAT THE CLIP MALFORMED AND DROPPED FROM THE JAW. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6:H4: INFO UNAVAILABLE. H6: CODE 400(OTHER): YEILDED JAWS. RESULTS OF EVAL: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.
FACILITY REPORTED THAT THERE WAS A BLOOD LEAK IN THE DIALYZER. EBL 250CC. THE NURSE WAS NOT ABLE TO TELL HOW MANY TIMES THE DIALYZER WAS USED. THERE WAS NO PT INJURY REPORTED. A SAMPLE ENVELOPE WAS SENT TO THE CLINIC ON 11/18/96.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. INSTRUMENT WOULD NOT FIRE. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED.
9/20/96 - MEDWATCH REPORT NOT RECEIVED BY MANUFACTURER. SUBMITTED INITIAL REPORT. AFUNCTIONAL EVALUATION COULD NOT BE PERFORMED AS THE DEVICE WAS RETURNED FULLY FIRED.
CUSTOMER REPORTED THE OUTPUT OF THE VAPORIZER WAS LOWER THAN EXPECTED. THERE WAS NO REPORTED PT INJURY.
THERE ARE MANY REPORTS IN THE MEDICAL LITERATURE WHICH SUGGEST THAT THE PERFORMANCE OF DIFFERENT TYPES OF HALOTHANE VAPORIZERS HAVE BEEN ADVERSELY AFFECTED BY CORROSION. THE REPORTS REFER TO A REACTION AMONG HALOTHANE, MOISTURE AND OTHER SUBSTANCES, SUCH AS CLEANING AGENTS, WHICH CONTRIBUTE TO THE DECOMPOSITION OF HALOTHANE. CO HAS RECEIVED A NUMBER OF REPORTS THAT CERTAIN VAPORIZERS FOR HALOTHANE HAVE HAD THE PERCENTAGE CONTROL DIAL STICK IN THE "OFF" POSITION OR HAVE DELIVERED CONCENTRATIONS OF ANESTHETIC AGENT DIFFERENT FROM THAT INDICATED BY THE PERCENTAGE CONTROL DIAL SETTING. NO REPORTS RECEIVED BY CO HAS INVOLVED PT INJURY. CO HAS THOROUGHLY INVESTIGATED THESE REPORTS AND HAS FOUND THAT THE REPORTED VAPORIZER OPERATION IS CAUSED BY THE CORROSION OF THE METAL INTERNAL CONTROL VALVE. CO HAS DETERMINED THAT SUCH CORROSION RESULTS FROM THE DECOMPOSITION OF HALOTHANE. IN MOST OF THE REPORTS RECEIVED BY CO, THE CORROSION OF THE INTERNAL CONTROL VALVE CAUSED THE VAPORIZER'S PERCENTAGE CONTROL DIAL TO STICK IN THE "OFF" POSITION, RENDERING THE VAPORIZER INOPERATIVE. HOWEVER, IN A NUMBER OF THE REPORTS WHERE THE VAPORIZER COULD BE OPERATED, THE DELIVERED CONCENTRATION OF ANESTHETIC AGENT WAS DIFFERENT THAN THE CONCENTRATION INDICATED ON THE VAPORIZER PERCENTAGE CONTROL DIAL. AS A RESULT OF THE INVESTIGATION, CO HAS DETERMINED THAT THE DECOMPOSITION OF HALOTHANE CAUSES THE RELEASE OF HALIDES WHICH MAY CORRODE METAL COMPONENTS, SUCH AS INTERNAL CONTROL VALVE, PARTICULARLY IN PRESENCE OF MOISTURE. CO FURTHER BELIEVES THAT A PRESERVATIVE ADDED TO THE HALOTHANE BY ITS MFRS TO IMPEDE DECOMPOSITION CAN LEAVE A RESIDUE WHICH MAY CAUSE VAPORIZER COMPONENTS, SUCH AS PERCENTAGE CONTROL DIAL, TO STICK. CO'S INVESTIGATION ALSO REVEALED THAT HALOTHANE IS USED INFREQUENTLY IN MANY HOSPITALS. AS A RESULT, VAPORIZERS FILLED WITH HALOTHANE MAY BE INACTIVE FOR LONG PERIODS OF TIME, THEREBY INCREASING LIKELIHOOD THAT CORROSION OF VAPORIZER'S METAL COMPONENTS WILL OCCUR. IN VIEW OF THE FINDINGS OF INVESTIGATION, CO WOULD LIKE TO CALL TO THE ATTENTION OF USERS OF VAPORIZERS FOR HALOTHANE THE INFO NOTED IN ITS MEDICAL DEVICE ADVISORY NOTICE DATED 5/9/96: TAKE STEPS TO INSURE STRICT COMPLIANCE WITH LABELING WHICH STATES IN PART TO TURN THE VAPORIZER OFF WHEN NOT IN USE AND DO NOT OPERATE VAPORIZER OTHER THAN WITH DRY MEDICAL GASES. ALSO MAINTENANCE SCHEDULE: EVERY TWO WEEKS WHEN THE AGEN LEVEL IS LOW, DRAIN THE CONTENTS OF VAPORIZER INTO AN APPROPRIATELY MARKED CONTAINER AND DISCARD AGENT, EVERY THREE YEARS VAPORIZER SHOULD BE SERVICED AT AN AUTHORIZED SVC CTR. WARNINGS INCLUDE: DO NOT PUT WATER OR ANY SOLVENT INTO A VAPORIZER, DO NOT IMMERSE VAPORIZER IN ANY LIQUID, INCLUDING WATER AND DO NOT AUTOCLAVE VAPORIZER. NEVER ALLOW CLEANING AGENTS TO ACCUMULATE EITHER IN FILLER, GAS INLET & OUTLET PORTS OR AROUND CONTROL DIAL. CHECK OUTPUT OF ANESTHETIC AGENT PERIODICALLY WITH AN AGENT MONITOR. THIS WOULD BE CONVENIENTLY PERFORMED FOLLOWING BI-WEEKLY DRAINING PROCEDURE.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED THE TED 12 BALLOON DID NOT WORK CORRECTLY AND UPON INSPECTION, HOLES WERE PRESENT IN THE BALLOON. A TOTAL OF THREE DEVICES EXHIBITED HOLES IN THE BALLOONS. METAL RETRACTORS WERE NOT BEING USED. IT WAS ALSO REPORTED THE BLUE INSUFFLATION BULB SEEMED TO FALL OFF EASILY. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: H4: INFO UNAVAILABLE: SEE CORRESPONDENCE LOG. 10/22/96 0915 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/23/96 1320 SURGEON RESPONDED. HE STATED HE FEELS THE BALLOON IS EXTREMELY FRAGILE AND NEEDS TO BE "BEEFED UP". HE STATED THE CASE WAS COMPLETED WITH ANOTHER MFR'S     BALLOON DISSECTOR. D6: THE OTHER 2 DEVICES WERE NOT RETURNED FOR EVAL. CATALOG # TED12. LOT # UNK. BATCH # UNK. H10: EVAL CODES FOR THE OTHER 2 DEVICES NOT RETURNED FOR EVAL: 09, NA, 68. BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE BALLOON HAD TORN AT THE DISTAL TIP, MAKING THE INSTRUMENT NON FUNCTIONAL. THE INSTRUMENT WAS REC'D WITH A TEAR IN THE BALLOON WHICH RAN ACROSS THE DISTAL TIP. THE TEAR WAS JAGGED AND WAS APPROX 3 INCHES IN TOTAL LENGTH. THE INITIAL TEAR WAS APPROX 1/8" IN LENGTH ON THE DISTAL TIP AND THEN PROGRESSED TO APPROX 3 INCHES IN LENGTH. THERE WERE NO ABRASION MARKS OBSERVED ON THE BALLOON. NO CONCLUSION COULD BE REACHED AS TO HOW THE BALLOON HAD BECOME TORN. THIS INQUIRY WAS ORIGINALLY REPORTED AS AN RPO (RECORD PURPOSES ONLY). EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. THE STAPLES DID NOT FORM PROPERLY. THE SURGEON MANUALLY SUTURED THE ANASTOMOSIS.
THE DEVICE WAS USED DURING AN OPERATIVE GYNECOLOGICAL PROCEDURE. THE TROCAR TIP DID NOT RETRACT DURING PENETRATION. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE ER320, FROM KIT FTR 12, MISFIRED CONTINUOUSLY. CLIPS WERE SHOOTING FROM THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.
H4: INFORMATION UNAVAILABLE.H6: CODE 400(OTHER): YEILDED JAWS
IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP REUSEABLE CLIP APPLIER, JAWS TOO WIDE TO FIT THROUGH A STANDARD 10/11MM TROCAR, AND WHEN PRESSURE APPLIED TO JAW TO INSERT IT, THE CLIP FALLS OUT OF THE JAWS ONCE THE INSTRUMENT IS IN THE ABDOMINAL CAVITY. JAWS ARE NOT ALIGNED. THERE WAS NO CONSEQUENCE TO THE PT.
TRACKING #.15744. D5; H4: INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
DURING PT MONITORING CRT DISPLAY BLANKED OUT.
THE LOCAL FACTORY SERVICE REP OBSERVED LACK OF DEVICE DISPLAY AND LOSS OF DEVICE POWER. THE DEVICE SYSTEMS ASSEMBLY WAS REPLACED. PROPER DEVICE OPERATION WAS THEN OBSERVED THOUGH FULL FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE. THE FACTORY OBSERVED AN INTEARMITTENT FAILURE OF THE ASSEMBLY TO ALLOW POWER ON. THIS DISCREPANCY WAS DETERMINED DUE TO A SHORT ON THE ASSEMBLY OF UNDETERMINED ORIGIN. EXCEPT AS PROVIDED BY 21 CFR 803.56, CO DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.
IT WAS REPORTED BY THE OPERATOR THAT THE UNIT WOULD CONTINUE TO RADIATE IF THEY HELD THEIR FINGER ON THE EXPOSURE BUTTON. THE UNIT WOULD NOT TIME OUT. FURTHER INVESTIGATION BY A SERVICE TECHNICIAN SHOWED THAT THE UNIT WAS IN FACT RADIATING. THE SERVICE TECHNICIAN CHECKED THE UNIT USING A FLOUROCARD, AND A VOLT METER TO VERIFY EXPOSURE. A TEST WAS ALSO CONDUCTED BY SWITCHING TUBEHEADS WITH A KNOWN OPERATIONAL UNIT AND THE TECHNICIAN GOT THE SAME RESULTS. THERE IS NO MENTION OF RADIATION OF A PT OR INJURIES IN THE REPORT.
86 -THIS UNIT WAS EVALUATED AND TESTED BY A DEALER SERVICE TECHNICIAN IN THE DR'S OFFICE WHO THEN REPORTED HIS FINDINGS TO CO BY PHONE. 68 -THIS IS A REPORT OF A POTENTIAL ACCIDENTAL RADIATION EXPOSURE FROM A DENTAL INTRA-ORAL X-RAY. BY DESIGN THE DOSAGE IS VERY MINIMAL AND IN THIS REPORT THERE WAS NO MENTION OF A PT BEING INVOLVED. THE OPERATOR STATED THAT THE MACHINE WOULD CONTINUE TO RADIATE FOR SOME PERIOD OF TIME IF THEY CONTINUE TO HOLD DOWN THE INITIATE BUTTON. THE MACHINE WAS TESTED BY A LOCAL DEALER SERVICE TECHNICIAN WHO THEN TOOK THE MACHINE OUT OF SERVICE AND REPORTED THAT THE DR WOULD NOT USE IT AND PLANNED TO BUY A NEW MACHINE.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP. THE LINEAR CUTTER DID NOT FIRE DURING THE PROCEDURE. SWITCHED TO A NEW INSTRUMENT TO COMPLETE SURGERY. THERE WAS NO CONSEQUENCE TO THE PT.
RESULTS OF EVALUATION: CONCLUSION BASED UPON INQUIRY INFO RECEIVED, VISUAL EXAMINATION, AND FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY INSTRUMENT REPORTEDLY "DID NOT FIRE" DURING SURGERY. INSTRUMENT WAS RETURNED WITH A BENT KNIFE, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED STAPLES WITHIN DESIGN SPECIFICATION. INSTRUMENT WAS DISASSEMBLED TO EXAMINE INTERNAL COMPONENTS AND NO OTHER DEFORMATIONS COULD BE IDENTIFIED. EXPERIENCE SURGEON REORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.
THE DEVICE WAS USED DURING AN UNSPECIFIED LAPAROSCOPIC PROCEDURE. THE SAFETY SHIELD WOULD NOT RETRACT. THE SURGEON USED ANOTHER INSTRUMENT AND CONTINUED THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
11/13/96 - MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG. THE CAUSE OF DEFECT COULD NOT BE RELIABLY DETERMINED AS ONLY A PORTION OF THE INSTRUMENT WAS RETURNED. THE PORTION RETURNED DID NOT DISPLAY ANY DISCREPANCIES.
BLOOD LEAK ON A FIRST USE DIALYZER. EBL LESS THAN 100CC. THERE WAS NO PT INJURY REPORTED. THE SAMPLE WAS DISCARDED.
CO HAS INFORMED THE MFG FACTORY OF THIS OCCURRENCE. THE LOT NUMBER AND PRODUCT CATALOG HAVE BEEN DOCUMENTED AND CO'S FACTORY IS INVESTIGATING THE POSSIBLE CAUSES OF THIS OCCURRENCE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO FROM THE MFG FACTORY'S EVALUATION WARRANTS A SUPPLEMENTAL SUBMISSION.
THE INSERT DID NOT SEAT ON BASEPLATE. AN ALTERNATE INSERT WAS USED. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
THIS MDR WAS A DUPLICATE REPORT OF 2219689-1996-00189 HOWMEDICA FILE NUMBER **840-19-96-10-18-B. FOR EVAL RESULTS SEE ABOVE MDR FOLLOW-UP.
COMPLAINANT ALLEGED THAT OVER THE PAST FEW MONTHS, STAFF MEMBERS HAVE INDICATED THAT WHEN THEY TOUCH THE UNIT'S MAIN SWITCH KNOB TO ADJUST THE JOULE SETTING, THE UNIT'S MONITOR SCREEN INTERMITTENTLY GOES BLANK. WHEN THE ALLEGED MALFUNCTION OCCURRS, THE STAFF TURNS THE UNIT OFF AND THEN ON AGAIN AND IT FUNCTIONS PROPERLY. THERE WERE NO ADVERSE EFFECTS ON THE PTS WHEN THE ALLEGED MALFUNCTION OCCURRED.
INVESTIGATION CONDUCTED. PART NOT RETURNED. DR DOES NOT STATE A REASON FOR THE FUTURE. THIS FILE IS CLOSED.
INVESTIGATON CONDUCTED. DR CITES CLASS 1 DEEP BITE WITH AN INCREASE DEVELOPMENT OF MUSCLES OF MASTICATION. THIS FILE IS CLOSED.
IT WAS REPORTED THE DEVICE WAS USED DURING A GASTRIC RESECTION PROCEDURE. IT WAS REPORTED THE SURGEON FIRED THE TL60 ACROSS THE PYLORUS OF THE STOMACH. AFTER THE FIRING, THE STAPLE LINE WAS INSPECTED AND IT WAS OBSERVED THE STAPLES DID NOT FORM PROPERLY. THE SURGEON THEN HANDSEWED THE SLUMP. THERE WAS NO CONSEQUENCE TO THE PT.
BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE RPT'D INCIDENT. THE INSTRUMENT WAS RETURNED WITH A RELOAD CARTRIDGE FULLY LOADED WITH STAPLES IN THE INSTRUMENT. THE INSTRUMENT WAS FIRED WITH THE RETURNED CARTRIDGE AND FIRED AND FORMED STAPLES AS DESIGNED ACROSS THE ENTIRE STAPLE LINE. THE INCIDENT THAT OCCURRED DURING SURGERY COULD NOT BE RECREATED. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE RPT'D INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS RPT'D IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED THE TED12 BALLOON BURST AFTER APPROX 22 PUMPS. THE DEVICE WAS TESTED PRIOR TO INSERTION. THE OTOMY CREATED WAS APPROX 19 TO 22 MM AND NO METAL RETRACTORS WERE NEAR THE BALLOON UPON INSERTION. A SECOND TED12 WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. 10/16/96 REP REPORTS THE BALLOON DID NOT BURST INTO PIECES, AND DID NOT REQUIRE RETRIEVAL OF ANY PIECES.
A1,2,3,4; B6,7; D10: INFO UNAVAILABLE. SEE CORRESPONSENCE LOG: 10/17/96 1517 DR. WILL NOT BE BACK IN THE OFFICE UNTIL NEXT WEDNESDAY. WILL SEND NNCL. 10/17/96 NNCL SENT. H4: INFO UNAVAILABLE. ADD'L MFR NARRATIVE: THE JAGGED TEAR ON THE DISTAL END OF THE BALLOON AND THE VISIBLE ABRASION MARKS IN THE AREA OF INITIAL DAMAGE INDICATE A HARD SURFACE MAY HAVE PINCHED THE BALLOON AND THE DISTAL EXTENSION RING. BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE BALLOON HAD TORN AT THE DISTAL TIP, MAKING THE INSTRUMENT NON FUNCTIONAL. THE INSTRUMENT WAS REC'D WITH A JAGGED TEAR ON THE DISTAL TIP WHICH WAS 1/2" IN LENGTH AND THERE WERE ABRASION MARKS OBSERVED ON THE BALLOON AT THE DISTAL RING. IT APPEARED FROM THE ABRASION MARKS, THAT THE BALLOON HAD BEEN PINCHED WITH SOMETHING EXTERNALLY AGAINST THE DISTAL EXTENSION RING, WHICH MAY HAVE THEN CAUSED THE BALLOON TO TEAR. THE BALLOON WAS NOTED TO BE COVERED WITH DRIED BODY FLUIDS. NO CONCLUSION COULD BE REACHED AS TO HOW THE BALLOON HAD BECOME TORN. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
THE INSERT DID NOT LOCK IN THE BASEPLATE. AN ALTERNATE INSERT WAS USED. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
UPON COMPLETION OF DEVICE EVALUATION, A SUPPPLEMENTAL REORT WILL BE SUBMITTED. F1-14 HAS BEEN COMPLETED BY THE MFR. INFO HAS BEEN REQUESTED FORM UF. IF IFNO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
INVESTIGATION CONDUCTED. DR CITES INFECTION AS POSSIBLE CAUSE OFR THE FAILURE. THIS FILE IS CLOSED.
COMPLAINANT ALLEGED THAT ON TWO SEPARATE OCCASIONS, MEDICS WERE MONITORING PTS (AGE AND GENERS UNKNOWN) AND THE UNIT'S MONITOR SCREEN DISPLAY BEGAN TO FADE AND BECAME UNREADABLE. THERE IS NO INDICATION OF ANY ADVERSE EFFECT ON THE PT.
THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE. THE TIP OF THE NEEDLE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
IT WAS REPORTED THE DEVICE WAS USED DURING A HEMICOLECTOMY. IT WAS REPORTED THE TL60 WAS PLACED ON TISSUE FOR THE FIRST FIRING, FIRED, AND EXCESS TISSUE WAS CUT OFF. UPON REMOVING THE DEVICE, NO STAPLES WERE OBSERVED IN THE TISSUE NOR THE DEVICE. THE SURGEON TOOK EXTRA TISSUE TO PERFORM A RIGHT HEMICOLECTOMY. THERE WAS NO CONSEQUENCE TO THE PT.
THE RPTR STATES AFTER SEVERAL ATTEMPTS, THE INSERT LOCKING MECHANISM DID NOT ENGAGE. AN ALTERNATE TIBIAL INSERT OF THE SAME SIZE WAS AVAILABLE AND  IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.
CORRECTED DATA: D6: LOT CODE=UMNXA. H4: MANUFACTURE DATE: 6/3/96. SUMMARY OF EVALUATION: THE TIBIAL INSERT WAS VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. THE ANTERIOR LOCKING TAB EXHIBITS GROSS DISTORTION DUE TO HAVING BEEN CRUSHED DURING THE INTRA-OPERATIVE ASSEMBLY ATTEMPT. IN ADDITION, THE PLASTIC ADJACENT TO THE LOCKING TAB HAS IDENTATIONS FROM INTERFERENCE WITH THE LOCKING POST OF THE BASEPLATE WHEN THE INSERT WAS IMPACTED. THESE CONDITIONS INDICATE THAT THE INSERT WAS NOT POSITIONED FULLY POSTERIOR WHEN IMPACTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS INSERT FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MANUFACTURE.THE EVALUATION RESULTS SUGGESTS THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH INTRA-OPERATIVE PROCEDURES. IMPACTION OF A MISALIGNED INSERT DAMAGES THE ANTERIOR LOCKING TAB WHICH THEN PRECLUDES PROPER ASSEMBLY ONTO THE BASEPLATE.
COMPLAINANT ALLEGED THAT A PT (AGE AND GENDER UNKNOWN) WAS BEING MONITORED DURING A TRANSPORT. THE PT'S ECG TRACE ON THE UNIT'S MONITOR SCREEN DISAPPEARED AND A GREEN DOT APPEARED IN THE MIDDLE OF THE SCREEN. THE MONITOR SCREEN LATER WENT BLANK. ANOTHER AMBULANCE MET THEM AND THE MEDICS OBTAINED ANOTHER UNIT (MFR UNKNOWN). THERE WAS NO ADVERSE EFFECT ON THE PT.
COMPLAINANT ALLEGED THAT STAFF MEMBERS WERE ATTEMPTING TO CARDIOVERT A MALE PT IN HIS SIXTIES. WHEN THE STAFF PRESSED THE SYNCH BUTTON, THE UNIT'S MONITOR SCREEN WENT BLANK. THE STAFF OBTAINED ANOTHER UNIT (MFR UNKNOWN) AND CONVERTED THE PT'S RHYTHM. THERE WAS NO ADVERSE EFFECT ON THE PT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS JAMMED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PT INJURY REPORTED.
1/14/96-MEDWATCH REPORT NOT REC'D BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
COMPLAINANT ALLEGED THAT A MALE NURSE WAS PERFORMING A ROUTINE SHIFT CHECK OF THE UNIT AND RECEIVED AN UNINTENDED DELIVERY OF ENERGY. THE UNIT WAS SET TO 360J. HE FELT THE ENERGY MOVE THROUGH HIS THUMBS AND THE ENERGY "KNOCKED HIM BACK AGAINST" A WALL. THE COMPLAINANT INDICATED THAT THE NURSE WAS USING HIS FINGERS TO DISCHARGE THE UNIT INSTEAD OF HIS THUMBS. THE NURSE WAS MONITORED FOR SEVERAL HRS AND THE FACILITY'S STAFF DETERMINED THAT HE WAS FINE. THE NURSE DID RECEIVE TWO SMALL BLISTERS ON HIS THUMBS, BUT THE BLISTERS WERE NOT TREATED. THE DEVICE'S OPERATOR'S GUIDE CONTAINS DETAILED INSTRUCTIONS FOR PERFORMING DAILY TESTS ON THE UNIT. PLEASE REFERENCE PAGE 40 FROM THE GUIDE.
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. THE CLIPS DID NOT ADVANCE. THE SURGEON APPLIED ANOTHER DEVICE. NO PT INJURY REPORTED.
7/11/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6.
DURING AN UNSPECIFIED PROCEDURE, INSTURMENT DID NOT FIRE PROPOERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, THE INSTRUMENT DID NOT CUT COMPLETELY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING A SUB TOTAL GASTRECTOMY PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON USED MANUALLY SUTURED TO COMPLETE THE PROCDDUE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
DURING AN UNSPECIFIED PROCEDURE. THE INSTRUMENT EJECTED CLIPS PREMATURELY AND CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED AONTHER DEVICE TO COMPLETE THE PROCEDURE, NO PT INJURY OCCURRED.
11/15/96-MEDWATCH REPORT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TIP DID NOT RETRACT AFTER PENETRATION. THE SURGEON COMPLETED THE PROCEDURE WITH THE DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE ON THE COLON. THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE WHITE GASKET FELL INTO THE PT. A RIGHT ANGLE DISSECTOR MAY HAVE BEEN USED WITH THE DEVICE. THE GASKET WAS RETRIEVED FROM THE PT. THERE WAS NO CONSEQUENCE TO THE PT.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THAT THE SILICON RING OF FLAPPER BULB DROPPED. THERE WAS NO CONSEQUENCE TO THE PT.
D5,6:H4: INFO UNAVAILABLE. RESULTS OF EVAL: CONCLUSION: THE INNER GASKET WAS INTACT BUT OUT OF POSITION. NO CONCLUSION COULD BE REACHED AS TO HOW THE INNER GASKET WAS OUT OG POSITION.
THE DEVICE WAS USED DURING A COLON RESECTION PROCEDURE. THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A HEMI COLECTOMY PROCEDURE. THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. CORRECTED DATA ENTERED IN F9.
DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP SAFETY DID NOT ACTIVATE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: INFO NOT PROVIDED BY AFFILIATE. D5,6; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
PT PUT LATEX CHEMO GLOVES ON OVER NON-LATEX GLOVES AND IMMEDIATELY AFTER SHE TOOK OFF BOTH GLOVES SHE EXPERIENCED ITCHING OF THE PALM OF HER LEFT HAND. SHE WAS SENT TO THE ER DUE TO PAST HISTORY.
12/16/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. ADDITIONAL DATA ENTERED IN D9. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE CLIPS DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
THE DEVICE WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
11/15/96-MEDWATCH REPORT NOT RECEICED BY MFR. SUBMISSION OF INITIAL REPORT OT FDA BY MFG.
THE DEVICE WAS USED DURING A HYSTERECTOMY PROCEDURE. THE INSTRUMENT WOULD NOT FIRE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PT INJURY REPORTED.
11/14/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE SAFETY SHIELD WOULD NOT RETRACT TO PENETRATE THE TISSUE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
12/17/96 - SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. ADDITIONAL DATA ENTERED IN D9. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
PT REPORTED AN INTERMITTENT BEEPING OF HIS DEFIBRILLATOR. COMPLETE BATTERY DEPLETION WAS EVIDENT. THIS DEVICE WAS IMPLANTED 8/21/95 AND PREVIOUS CHECKS DID NOT INDICATE A PROBLEM.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. THE STAPLES DID NOT LOCK. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
ADDITIONAL INFO RECEIVED FROM MFR ON 09/24/1998: INVESTIGATIONS INDICATE THAT THE SAMPLE RETURNED WITH THIS COMPLAINT IS NOT A GRAPHIC CONTROLS CANADA PRODUCT.
THE PRODUCT WAS NOT CLINICALLY APPLIED. THE SUTURE BREAKS EASILY. NO PT INJURY REPORTED.
DEVICE WAS USED DURING A LAPAROSCOPIC COLON. THERE WERE SIX DEVICES USED DURING THE CASE. ALL OF THE DEVICES LEAKED. THE SURGEON REPLACED ALL SIX WITH ANOTHER. TWO OF SIX LEAKED AND THOSE WERE REPLACED WITH TWO MORE OF THE SAME MODEL. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: INFO UNAVAILABLE. 10/17/96 1454 MESSAGE AND 800# KEFT FOR MD TO CALL BACK. 10/18/96 NNCL SENT. 10/18/96 1640 NNCL RETREVED. SURGEON EXPLAINED A WHILE INTO THE CASE, HE EXPERIENCED SIGNIFICANT PNEUMO LEAKAGE AND WAS NOT ABLE TO GET PRESSURE GREATER THAN 10. HE DID NOT EXAMINE THE GASKETS CLOSELY TO SEE IF TEARS WERE PRESENT. HE EXPLAINED HE WAS USING AN ENDO BABCOCK. USED MORE TROCARS TO COMPLETE THE CASE. D5,6; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. INFO ABOVE IS THE SAME FOR INSTRUMENTS #2 THROUGH #8.
THE PRODUCT WAS IN USE FOR AT LEAST 2 HOURS. AT THE END OF THE PROCEDURE, THE ESOPHAGEAL STETHOSCOPE WAS REMOVED. AS THE TUBE WAS REMOVED, THE BALLOON DISCONNECTED FROM THE TUBE AS IT WAS JUST ABOVE THE VOCAL CORDS. THE BALLOON WAS EASILY REMOVED AND NO INJURY WAS REPORTED.
IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "NO", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? NO. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "NO", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
THE PRODUCT WAS NOT CLINICALLY APPLIED, SUTURE BREAKS EASILY. NO PT INJURY REPORTED.
CO'S TESTING INDICATES THAT, ALTHOUGH THE CLOSURE IS LOOSE ON THE CONTAINER, THIS HAS NOT COMPROMISED THE INTEGRITY OF THE UNIT, AS THE VACUUM IS INTACT AND REMAINS AT SPECIFICATION. REVIEW OF THE IN-PROCESS MFG RECORDS FOR LOT J6H042 SHOWED NO MFG NON-CONFORMANCES ASSOCIATED WITH THIS REPORT. THE LOOSE CLOSURE IS EITHER DUE TO DAMAGE DURING SHIPPING/HANDLING OR IMPROPER CRIMPING DURING ASSEMBLY. AS A PART OF CO'S CONTINUAL QUALITY IMPROVEMENT PROGRAM, OUR GLASS FILLING MFG OPERATION HAS BEEN RELOCATED TO A NEW CLEAN ROOM LOCATION WITH COMPLETE UPGRADES TO ALL THE MFG EQUIPMENT. THE EQUIPMENT AND OPERATIONS HAVE BEEN RE-CALIBRATED AND RE-VALIDATED. CO'S EVALUATION CONCLUDED THE CAUSE OF THE DISASSEMBLY TO BE DUE TO INSUFFICIENT SOLVENT APPLICATION BETWEEN THE TUBING AND BAG ASSEMBLY. THIS TYPE OF DEFECT IS DIRECTLY RELATED TO AN OPERATOR/MFG ERROR. AS A RESULT OF CO'S FINDINGS, THE PRODUCTION WORKERS IN THE MFG AREA AND PRODUCT ENGINEERS HAVE BEEN INFORMED OF THIS COMPLAINT. ALSO, THE ASSEMBLERS HAVE BEEN PROVIDED ADD'L TRAINING TO HELP ENSURE THAT THIS PROBLEM DOES NOT OCCUR IN THE FUTURE.
IT WAS REPORTED THE DEVICE WAS USED DURING A TAKE DOWN COLOSTOMY PROCEDURE. IT WAS REPORTED THE SURGEON WAS PREPARING THE BOWEL FOR ANASTOMOSIS. THE ANVIL OF THE CDH25 WAS PLACED IN THE DISTAL STUMP OF THE RECTUM WITH A PURSE STRING. A COLOTOMY WAS CREATED IN THE PROXIMAL COLON. THE DEVICE WAS GUIDED DOWN THROUGH THE COLOTOMY TO THE DISTAL END OF THE PROXIMAL BOWEL. THE TROCAR TIP WAS EXTENDED AND DOCKING OF THE ANVL TO TROCAR OCCURRED. THE PROPER CLOSURE WAS OBTAINED AND THE DEVICE WAS FIRED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THERE WERE TWO COMPLETE DONUTS. UPON REVIEW FO THE ANASTOMOSIS, THE STAPLES WERE NOT FORMED AND THE ANASTOMOSIS FELL APART. THE SURGEON WAS REQUIRED TO HANDSEW THE ANASTOMOSIS. THERE WAS NOT CONSEQUENCE TO THE PT.
A1.2.3.4; B6,7; D10: INFO UNAVAILABLE. SEE CORRESPONDENCE LOT: 10/17/96 1510 MESSAGE AND 800 LEFT FOR MD CALL BACK. 10/18/96 NNCL SENT. D5; H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. BASED ON INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT APPEARS AS IF A FULL STROKE WAS NOT ACHEIVED. THIS IS EVIDENCED BY THE BREAKAWAY WASHER BEING RETURNED UNCUT BUT WITH AN INDENTATION AROUND THE ENTIRE CIRCUMFERENCE. IT SHOULD BE NOTED THAT TO ENSURE THE INSTRUMENT HAS BEEN FIRED THROUGH A COMPLETE FIRING STROKE, THE FIRING TRIGGER MUST BE COMPLETELY ACTUATED DOWN AND A TACTILE FEEDBACK WILL BE FELT WHEN THE BREAKAWAY WASHER IS FULLY CUT. THIS WILL ENSURE THAT THE INSTRUMENT FORMS THE STAPLES AND CUTS THE DONUTS AS DESIGNED. THE INSTRUMENT WAS RELOADED AND FIRED. IT FIRED, FORMED THE STAPLES AND CUT THE BREAKAWAY WASHER AND TEST SKIN AS DESIGNED. MFR AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVE TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
11/14/96-MEDWATCH REPORT NOT RECEIVED MFR. SUBMISSION OF INITIAL REPORT TO FDA.
DURING TESTING, UNIT SHOWED 10J ON MAIN CAPACITOR AT POWER-UP, ERROR CODE 010 WHEN CHARGE ATTEMPTED. RESTARTING SEVERAL TIMES SHOWED REPEAT OF SAME.
ERROR CODE 010 NOT VERIFIED. OBSERVED ERROR CODE 001 UPON CHARGING. FOUND 15 AMP FUSE BLOWN AND CONTAMINATION ON CIRCUIT BOARDS (SYSTEM CONTROL BOARD NEAR CN2; H.V. BOARD NEAR DN4). UNIT HAD GOTTEN WET INSIDE, POSSIBLY CAUSING EC 010. CLEANED CIRCUIT BOARDS, REPLACED FUSE AND CONNECTOR CN2. UNIT FUNCTIONS CORRECTLY. MATRX MEDICAL INC. DOES NOT CONSIDER THIS DOCUMENT OR ITS CONTENTS TO BE AN ADMISSION THAT A MATRX PRODUCT IS DEFECTIVE OR THAT A MATRX PRODUCT HAS CAUSED A DEATH OR SERIOUS INJURY. THIS DOCUMENT CONTAINS CONFIDENTIAL OR PROPERIETARY INFO OF MATRX. NEITHER THIS DOCUMENT NOR THE INFO THEREIN IS TO BE REPRODUCED, DISTRIBUTED, USED OR DISCLOSED, EITHER IN WHOLE OR IN PART, EXCEPT AS SPECIFICALLY AUTHORIZED BY MATRX MEDICAL INC.
WHILE DOING A ROTATOR CUFF REPAIR A NEEDLE FROM #2 TI-CRON BROKE OFF IN A PATIENT'S BONE. THE DOCTOR WAS UNABLE TO RETRIEVE THE NEEDLE. NEITHER END OF THE NEEDLE PROTRUDED THROUGH THE BONE AND NO SHARP EDGES WERE NOTED. NO X-RAYS WERE TAKEN.
DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. TWO DEVICES LEAKED. TWO NEW DEVICES OF THE SAME MODEL WERE OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B6,7; D10: INFO UNAVAILABLE. 10/17/96 1454 MESSAGE AND 800# LEFT FOR MD CALL BACK. 10/18/96 NNCL SENT. 10/18/96 1640 NNCL RETRIEVED. SURGEON EXPLAINED A WHILE INTO THE CASE, HE EXPERIENCED SIGNIFICANT PNEUMO LEAKAGE AND WAS NOT ABLE TO GET THE PRESSURE GREATHER THAN 10. HE DID NOT EXAMINE THE GASKETS CLOSELY TO SEE IF TEARS WERE PRESENT. HE EXPLAINED HE WAS USING AN ENDO BABCOCK. USED MORE TROCARS TO COMPLETE THE CASE. ALL INFO IN SECTION D1 THROUGH D10 IS THE SAME FOR DEVICE #2 WITH THE EXCEPTION OF D5. EXPIRATION DATE FOR ADEVICE #2 IS UNK, INFO IS UNAVAILABLE. F9 FOR DEVICE #2 IS UNK, INFO IS UNAVAILABLE. ALL INFO IN SECTION H1 THROUGH H10 IS THE SAME FOR DEVICE #2 WITH THE EXCEPTION OF H4. MFG DATE FOR DEVICE #2 IS UNK, INFO IS UNAVAILABLE. (A,B) BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE SLEEVES "LEAKED" DURING SURGERY DUE TO CUT OUTER GASKETS. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. A) T511 ADAPTOR AND MS512 REDUCER ATTACHED - CONFORMING. EACH INSTRUMENT IS EXAMINED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTONS PROPERLY. THE ASSEMBLY LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
PUMP (FOR TUBE FEEDINGS) TUBING DISCONNECTED AT THE BLUE FLANGE (PIECE THAT PRIMES THE TUBING) WAS LEAKING. TUBING FOR BOTH PTS WERE CHANGED.
CUSTOMER REPORTED PT DIED, 10/24/1996. NURSING REPORTEDLY "ATTEMPTED TO INSERT ENTERIFLEX FEEDING TUBE. SEVERAL ATTEMPTS WERE MADE. RESISTANCE MET-CHECKED END TUBE IN WATER, WHEN BUBBLED-REMOVED IMMEDIATELY. ATTEMPTS TERMINATED AT 10:20 AM. PHYSICIANS NOTIFIED. AT 11:00 AM PT EXPERIENCED RESPIRATORY DISTRESS. CODE CALLED, PT INTUBATED. CHEST TUBE PLACED. TRANSFERRED TO CRITICAL CARE. PT DIED OF TENSION PNEUMOTHORAX, RESPIRATORY ARREST."
REFERENCE MFR. COMPLAINT #V96-10-25-231. PT WAS AN ELDERLY FEMALE WITH THROAT ANOMALIES RESULTING FROM PREVIOUS SURGERIES. PLACEMENT OF THE FEEDING TUBE WAS DIFFICULT DUE TO CONDITION OF PT'S THROAT. RN PLACING TUBE CAUSED PNEUMOTHORAX. FAMILY REFUSED ADDITIONAL INTERVENTION OF BEHALF OF THE PT AND SHE EXPIRED. EVALUATION OF THE RETURNED USED DEVICE REVEALED IMPROPER USER TECHNIQUE PER PACKAGE LABELING. PT'S PREEXISTING CONDITIONS FIT PROFILE OF HIGH RISK PT. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OF THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED. UF# 39C00001-1996-6.
A DRAINAGE CATHETER WAS USED TO PERFORM AN ALCOHOL ABLATION PROCEDURE. THE ALCOHOL WAS INJECTED INTO THE PT VIA THE CATHETER. DURING REMOVAL THE PIGTAIL DETACHED AND REMAINED IN THE PT'S RENAL CYST. AS THE PT IS EXPERIENCING OTHER UNRELATED PROBLEMS, A DECISION HAS BEEN MADE NOT TO RETRIEVE THE DETACHED SEGMENT. NO FURTHER ATTEMPTS AT RETRIEVAL WILL BE MADE. THE DEVICE IS CURRENTLY BEING EVALUATED BY THIS MFR. UPON COMPLETION OF THE EVALUATION, A SUPPLEMENTAL MW FORM WILL BE FORWARDED UNDER THE ABOVE SEQUENCE NUMBER. THIS DEVICE IS A DRAINAGE CATHETER AND THE DIRECTIONS FOR USE OUTLINE APPROPRIATE USAGE OF THIS DEVICE. CO NON INDICATED USE OF THIS DEVICE CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE. CO'S DIRECTIONS FOR USE STATE: "THIS CATHETER IS DESIGNED FOR EXTERNAL OR INTERNAL PERCUTANEOUS DRAINAGE OF THE BILIARY SYSTEM".
THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE PIGTAIL OF THE DEVICE WAS NOT RETURNED FOR EVAL AND APPEARED TO HAVE BEEN TORN OFF RIGHT AT THE BASE OF THE PIGTAIL APPROX. SIX MILLIMETERS DISTAL OF THE PROXIMAL SUTURE HOLE. THE EXTRUSION AT THE POINT OF SEPARATION WAS JAGGED BUT THE EDGES WERE SMOOTH. THE EXTRUSION ITSELF WAS STILL PLIABLE AND NO INDICATIONS OF MATERIAL DEGRADATION WAS FOUND. A LONGITIDUNAL SPLIT WAS LOCATED AT THE DISTAL END OF THE EXTRUSION THAT EXTENDED PROXIMALLY UP THE CATHETER THROUGH THE PROXIMAL SUTURE HOLE. THE STOPCOCK OF THE DEVICE WAS CUT OFF APPROX. TWO TO THREE CENTIMETERS BELOW THE HEAT SHRINK. CO FOLLOWUP INDICATED THIS DEVICE WAS BEING USED OFR A NON-INDICATED PROCEDURE. THE ENGINEERING EVAL FOUND NO MATERIAL DEGRADATION RATHER A LONGITUDINAL SPLIT AND SMOOTH EDGES CONSISTENT WITH EXCESSIVE FORCE. THEREFORE CO DOES NOT ATTRIBUTE THIS EVENT TO THE DEVICE.
THE VENTILATOR FAILED TO CYCLE WHEN INITALLY PLACED ON PT.
THE DEVICE WAS USED DURING AN ABDOMINAL HYSTERECTOMY. IT WAS REPORTED BY THE REP. THAT THE INSTRUMENT DID NOT WORK PROPERLY. A NEW INSTRUMENT WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.
EVALUATION SUMMARY  INADVERTENTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE RETURNED CARTRIDGE HAD A BROKEN LEFT INNER ALIGNMENT FINGER BROKEN OFF AND MISSING. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.
THE REPLACED STEPPER MOTOR WILL BE RETURNED TO THE MFR FOR EVAL.
WHILE ATTEMPTING TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE PT'S RIGHT CORONARY ARTERY, THE GUIDEWIRE MIGRATED DISTALLY INTO THE SMALL CORONARY VESSELS AND THE PROTECTIVE SHEATH WAS "DISRUPTUED." THE STENT APPEARED TO BE DEPLOYED; HOWEVER, AN ANGIOGRAM REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED PROXIMAL TO THE TARGET LESION SITE AND THAT THERE WAS AN AREA OF DISSECTION. A SMALL DYE STAIN WAS ALSO OBSERVED AT THE APEX ON THE ANGIOGRAM. ATTEMPTS TO DEPLOY A SECOND CORONARY STENT WITH DELIVERY SYSTEM WERE UNSUCCESSFUL. THE PT BECAME HYPOTENSIVE AND CONFUSED. AN ECHOCARDIOGRAM CONFIRMED PERICARDIAL EFFUSION AND RIGHT ATRIAL COLLAPSE. PERICARDIOCENTESIS WAS PERFORMED. THE DECISION WAS MADE TO SEND THE PT FOR URGENT CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUEALAE REPORTED RELATIVE TO THE EVENT.
SURGEON WAS COAGULATING AROUND TONSIL WHEN NURSE NOTICED THAT THE ACTION WAS CAUSING A BURN TO THE PT'S MOUTH. PROCEDURE STOPPED AND INSTRUMENT REPLACED.
PREDIALYSIS BP 150/80 TEMP 98.4 PULSE 82. DIALYSIS WAS INITIATED AT 11:40 AM VIA LEFT SUBCLAVIAN CATHETER. BFR 400 CC/MIN BP 150/80. AT NOON THE PT WAS CHECKED AND BP WAS 150/88. AT 12:30 PM THE TECH APPROACHED THE PT TO TAKE HIS BLOOD PRESSURE. BLOOD WAS NOTED ON THE FLOOR UNDERNEATH THE DIALYSIS CHAIR. THE PT HAD A TOWEL COVERING HIS CHEST. WHEN THE TOWEL WAS LIFTED TO CHECK THE SUBCLAVIAN AND BLOODLINES, IT WAS NOTED THAT THE VENOUS LINE WAS SEPARATED FROM THE CATHETER WITH APPROX AN INCH OF SPACE BETWEEN THE END OF THE VENOUS LINE AND THE CATHETER. THE PT WAS PLACED IN TRENDELENBURG POSITION AND THE BLOOD PUMP WAS STOPPED. THE PT WAS UNRESPONSIVE WITH NO APPARENT BP, PULSE OR RESPIRATIONS. THE PT WAS PLACED ON THE FLOOR, CPR WAS INITIATED AND AN IV INFUSION OF NORMAL SALINE WAS ATTACHED TO THE CATHETER. THE PT WAS TRANSPORTED FROM THE DIALYSIS UNIT TO THE HOSP WITH CPR IN PROGRESS. THE PT EXPIRED AT THE HOSP. AFTER FURTHER EVALUATION IT COULD NOT BE DETERMINED HOW THE VENOUS LINE BECAME SEPARATED FROM THE SUBCLAVIAN CATHETER. THE DIALYSIS MACHINE DID NOT ALARM PRIOR TO THE EVENT. A TECHNICAL EVALUATION OF THE MACHINE DID NOT IDENTIFY ANY PROBLEMS WITH THE FUNCTIONING OF THE MACHINE.
THE SUSPECT DEVICE WAS RECEIVED IN PACKAGING THAT IDENTIFIED IT AS ANOTHER CO BLADE. UPON EVALUATION, IT WAS DISCOVERED TO BE A CO BLADE. THE ACTUAL DEVICE WAS RETURNED TO CO AND EVALUATED ON 11/4/96. THE SAMPLE WAS RECEIVED IN A CONDITION THAT WOULD ONLY ALLOW VISUAL EXAMINATION. EVALUATION REVEALED THAT THE PRODUCT PERFORMED AS INTENDED. THE ELECTRODE HAD BEEN BENT AT A 90 DEGREE ANGLE ABOUT 1/8" AT THE VERY TIP WHERE THE INSULATION BEGINS.
TWO BALLOONS RUPTURED IMMEDIATELY UPON INFLATION DURING AN ILIAC ANGIOPLASTY OF AN EXTREMELY CALCIFIED LESION. OTHER BALLOON CATHETERS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICES HAVE BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. SINCE CO'S FOLLOW UP INDICATED THESE DEVICES WERE USED IN A CALCIFIED LESION CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICES. HOWEVER, WITHOUT EVALUATING THE DEVICES, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR FOR USE STATE: "DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON, THESE BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INTRO OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY".
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. 3 IMPLANTS WERE PLACED IN CLASS II BONE DURING A ROUTINE PROCEDURE. 2 WEEKS POST-OP, THE PT PRESENTED ASYMPTOMATIC AND A DIAGNOSIS OF PERAPICAL ABSCESS FOR SITE #21 WAS MADE. SITE #20 WAS EVALUATED AT THAT TIME AND THE IMPLANT APPEARED FINE. IMPLANT #21 WAS REMOVED, BUT THE CLINICIAN BELIEVES THAT THE INFECTION DID SPREAD TO SITE #20. THE OTHER IMPLANTS HAVE NOT YET BEEN REMOVED.
SURGEON REPORTS HE NOTICED A CRACK IN THE MIDDLE OF THE HAPTIC AFTER  INSERTION OF LENS INTO THE CAPSULAR BAG. HE REPORTS HE HAD TO WIDEN THE INCISION ON ORDER TO REMOVE THE LENS.
THE EVALUATION RESULTS COMFIRMED A MARK ON THE LENS OPTIC AS REPORTED BY THE IMPLANTING SURGEON DUE TO FOLDING TECHNIQUE. THIS REPORT WAS MAILED IN TO FDA ON: 2/21/97.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. TWO IMPLANTS WERE PLACED IN CLASS II BONE DURING A COMPLEX PROCEDURE IN WHICH THE MORPHOLOGY OF THE LINGUAL ASPECTS OF THE MANDIBLE COMPLICATED PLACEMENT. THE IMPLANT IN SITE #28 WAS REMOVED 1 MONTH POST-OPERATIVELY.
REASON FOR EXPLANT STATED AS "INFECTION" ON EXPLANT FORM.
INFORMATION REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD AND THE ADDITIONAL TESTING PERFORMED THROUGH THE ANALYSIS LABORATORY INDICATED THIS VALVE WAS A NORMAL FUNCTIONING PROSTHESIS WHICH COMPLIED WITH CO SPECIFICATIONS AT THE TIME OF MFR. RESULTS OF THIS INFORMATION REMAIN INCONCLUSIVE DUE TO THE FACT CO HAS NOT RECEIVED ADDITIONAL INFORMATION WHICH MAY HAVE AIDED IN THE EVALUATION OF THIS EXPLANTED VALVE. THE VEGETATIONS REFERRED TO BY DR. WERE NOT OBSERVABLE BY ANOTHER  UPON THE VALVE'S RETURN TO CO. IT IS POSSIBLY ANY VEGETATIONS OBSERVED INTRAOPERATIVELY WERE REMOVED PRIOR TO THE VALVE BEING RETURNED FOR EVALUATION. THE CAUSE OF THE INFECTION REMAINS UNK; HOWEVER, IT WAS NOT DUE TO AN INTRINSIC VALVE DEFECT.
THE FROM AXLE ON A POWER WHEELCHAIR COLLAPSED. THIS ALLEGEDLY RESULTED IN THE USER SUSTAINING A BROKEN FOOT AND SPRAINED ANKLE. NO FURTHER DETAILS HAVE BEEN PROVIDED AND THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION.
THE DEVICE WAS USED DURING A LAPARASCOPIC ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED THE DEVICE MISFIRED. DIATHERMY WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO CONSEQUENCE TO THE PATIENT. 8/7/96 THE INSTRUMENT WAS FIRED ONCE SUCCESSFULLY, RELOADED AND PLACED IN VIVO. WHEN SECURED AROUND THE BROAD LIGAMENT AN ATTEMPT WAS MADE TO FIRE THE INSTRUMENT AND WAS CONSIDERED A FAILED ATTEMPT BY THE SURGEON. THE RELOAD CARTRIDGE (CURRENTLY SITUATED IN THE INSTRUMENT) WAS RETURNED. DIATHERMY WAS USED ALONG THE STAPLE LINE AS THE CONSULTANT CONSIDERED THAT EXCESS BLEEDING AND NOT OOZING, WAS OCCURRING AT THE STAPLE LINE. 8/3/96 FIRST FIRING WAS OK, THE RELOAD MISFIRED.
H6; CODE 400: INSTRUMENT RETURNED WITH BROKEN TRIGGER TEETH AND BENT KNIFE. CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.
TWO BALLOONS DEVELOPED LEAKS ON THE FIRST INFLATION DURING A FEMORAL/POPLITEAL ANGIOPLASTY OF A CALCIFIED LESION. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICES WERE REC'D, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL REVEALED LEAKS IN BOTH BALLOONS. SCRATCHES WERE NOTED ON THE BALLOON SURFACES. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. THESE DEVICES DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP EXTERNAL SOURCE, SCRATCHES ON THE BALLOON MATERIAL. CO'S FOLLOW UP ALSO INDICATED THESE DEVICES WERE USED IN A CALICIFED LESION. CO BELIEVES THESE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICES. CO'S DIRECTIONS FOR USE STATE: "DUE TO EXTREMELY THIN WALL THICKNESS OF THE WING (BALLOON, THIS DEVICE SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS. IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE".
2 MINUTES INTO TREATMENT THE PT COMPLAINED OF FEELING DIZZY AND THEN IMMEDIATELY STOPPED BREATHING. THE PT BECAME CYANOTIC AND WAS PLACED IN TRENDELENBURG. THE PT WAS GIVEN NORMAL SALINE. BP 60/PALP-TO 100-PALP. 911 CALLED AND WHILE GETTING AN AIRWAY READY FOR THE PT HE BEGAN BREATHING ON HIS OWN. THE ENTIRE EPISODE LASTED APPROX 30-45 SECONDS. THE MD WAS NOTIFIED THE PT'S VITAL SIGNS WERE STABLE AND TREATMENT WAS RESUMED USING A DIFFERENT DIALYZER WITHOUT FURTHER INCIDENT. THE SAMPLE WAS DISCARDED BY THE CLINIC.
ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S LEFT ANTERIOR DESCENDING ARTERY WITH THE PROTECTIVE SHEATH RETRACTED WERE UNSUCCESSFUL. DURING WITHDRAWAL OF THE SDS AND STENT, THE STENT DISLODGED IN THE BRACHIAL ARTERY. THE STENT WAS SUCCESSFULLY RETRIEVED UTILIZING A MICROSNARE. THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
PRODUCT LABELING STATES THAT THE SHEATH SHOULD NOT BE WITHDRAWN UNTIL THE OPERATOR IS READY TO EXPAND THE STENT.
H10. THE MFR QUESTIONS THE USE OF DEVICE CODE 1166 BY THE DISTRIBUTOR SINCE THERE IS NO EVIDENCE OF DIALYZER FAILURE. PT REACTIONS ARE IN THE DEVICE LABELING. ADD'L INFO PROVIDED TO THE MFR INDICATED THAT THE DIALYZER WAS ON ITS 2ND REUSE. A CLINICAL VARIANCE REPORT PROVIDED TO THE MFR DESCRIBES THE REACTION AS A "SEIZURE" AND STATES "HAS HAD SIMILAR EPISODES IN THE PAST." FACILITY HAS CHANGED TO SINGLE USE DIALYZER FOR THE PT.
DURING AN ATTEMPT TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S RIGHT CORONARY ARTERY, A ARTERIAL VASOSPASM OCCURRED AND THE STENT DISLODGED OFF THE BALLOON CATHETER IN THE CORONARY CIRCULATION. THE PT WAS SENT FOR URGENT CORONARY ARTERY BYPASS GRAFT SURGERY. SURGERY WAS SUCCESSFUL AND THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. ONE IMPLANT WAS PLACED IN SITE #3 IN CLASS IV BONE. A SINUS LIFT WAS COMPLETED DURING THE PROCEDURE USING FREEZE-DRIED BONE. THE IMPLANT WAS REMOVED 1 MONTH POST-OP DUE TO INFECTION.
A BALLOON RUPTURED IMMEDIATELY UPON INFLATION DURING AN ILIAC ANGIOPLASTY OF AN EXTREMELY CALCIFIED LESION. OTHER BALLOON CATHETERS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT PT COMPLICATIONS. THE DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. SINCE CO'S FOLLOW UP INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY".
ELECTRONIC TESTING OF THE RETURNED SENSOR (LOT# T031) WAS PERFORMED. A SIMULATED ASSAY WAS IMPLEMENTED AND MET SPECIFICATIONS. NO PHYSICIAL DEFECTS WERE OBSERVED RELATIVE TO THE SENSOR. THE LED DISPLAY FUNCTIONED APPROPRIATELY WITH ALL SEGMENTS VISIBLE. SENSOR ELECTRONIC FUNCTIONALITY WAS WITHIN SPECIFICATION. A CALIBRATION CODE CHANGE COULD NOT BE DUPLICATED DURING THE TESTING OF THE SENSOR. THE ONLY CONCLUSION IS THAT THE USER OF THE SYSTEM CALIBRATED THE SENSOR USING IMPROPER TECHNIQUE AND/OR MATERIALS. NO FURTHER INVESTIGATION IS REQUIRED.
11/14/1996-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA.
DIALYSIS TREATMENT INITIATED AT 6:40 AM. PRE BP 140/100 SITTING. 150/60 STANDING. AT 7:25, VENOUS LINE AND DIALYZER CHANGED DUE TO INCREASING VENOUS PRESSURE AND BLACK APPEARANCE. PT BECAME UNRESPONSIVE. TOTAL OF 2100 CC NSS GIVEN. PT RESPONDED TO FLUID BLOOD RETURNED TO PT AND MACHINE PULLED FROM SVC. PT HAD LOST 1.6 KG WITH UFR/HR SET AT .8. TREATMENT RESTARTED ON A DIFFERENT MACHINE. PT COMPLETED TREATMENT WITHOUT FURTHER DIFFICULTIES. THE FACILITY CHIEF TECH REMOVED THE MACHINE TO THE TECHNICAL AREA AND PERFORMED UF PRESSURE TESTS. THE MACHINE FAILED HIGH. TMP TEST AND POSITIVE PRESSURE HOLDING TEST. MFR VERIFIED THAT THE MACHINE HAD A UF CHECK VALVE WHICH WAS NOT FUNCTIONING PROPERLY. THE VALVE WAS REPLACED. FURTHER FACILITY INVESTIGATION REVEALED THAT THE CLINICAL STAFF WERE NOT PROPERLY PERFORMING PRESSURE HOLDING TESTS PRIOR TO TREATMENT INITIATION.
THE BALLOON BURST DURING A PROCEDURE TO REMOVE A CLOT THAT FORMED IN THE SUPERIOR MESENTARY ARTERY. A SMALL AMOUNT OF CLOT WAS REMOVED FROM THE PROXIMAL END OF THE ARTERY, BUT THE BALLOON BURST WHEN ATTEMPTING TO EXTRACT FROM THE DISTAL END. RETRIEVAL OF THE BALLOON WAS UNSUCCESSFUL. THE PATIENT IS DOING FINE.
H3. EVALUATION OF PRODUCT INCONCLUSIVE SINCE ONLY CATHETER BODY WAS RETURNED. CATHETER BODY IS IN GOOD CONDITION.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANTS. IMPLANTS ARE 2 OF 4 PLACED IN ROUTINE PROCEDURES IN CLASS III BONE. THE IMPLANT IN SITE #6 WAS A REPLACEMENT IMPLANT WITH BONE AUGMENTATION. THE CLINICIAN REPORTS THAT THE QUALITY OF THE MAXILLARY BONE WAS POOR AND THAT  THERE WAS NO BONE GROWTH IN THE HOLLOW PORTION OF THE IMPLANTS. THE PT REPORTED THAT THEY BECAME SORE IN 9/96 BUT DID NOT TELL THE OFFICE UNTIL 10/22/936. THE IMPLANTS WERE NOT MOBILE WHEN LAST CHECKED BY HER ORTHODONTIST. THE IMPLANT IN SITE #6 WAS REMOVED 4.5 MONTHS POST-OP AND THE IMPLANT IN SITE #11 WAS REMOVED APPROX 7 MONTHS POST-OP.
PT HOOKED UP TO ANESTHESIA BREATHING CIRCUIT. PT WAS NOT GETTING AIR DUE TO OBSTRUCTION OF MASK ELBOW. DOC DISCONNECTED ELBOW AND CONNECTED MASK DIRECTLY TO TUBING. PT WAS STABILIZED.
THE REPORTED COMPLAINT OF OCCLUDED ELBOW WAS VERIFIED. IT WAS DETERMINED THAT THIS DEFECT ORIGINATED IN THE MOLD CAVITY FOR THE BREATHING CIRCUIT ELBOW. TO CORRECT THIS PROBLEM WE HAVE VOLUNTARILY RECALLED ALL AFFECTED PRODUCT. PRODUCT WILL BE REWORKED AND A NEW ELBOW WILL REPLACE THE AFFECTED ELBOWS. EFFECTIVE IMMEDIATELY ALL BREATHING CIRCUITS WILL BE 100% TESTED FOR FLOW AND LEAKAGE, AS WELL AS AN INCREASED LEVEL OF VISUAL INSPECTION. THE VISUAL INSPECTION INCLUDES USING A PIN GAUGE DESIGNED TO DETECT OCCLUSIONS. IN ADDITION, WE ARE IN THE PROCESS OF MFG A NEW MOLD FOR THE ELBOW COMPONENT. NO FURTHER INFO IS ANTICIPATED FOR THIS REPORT.
PER THE INFO PROVIDED TO CO THROUGH THE INTERNATIONAL REP, THE DEVICE WAS REMOVED DUE TO AN "INFECTION". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND NOT REPLACED AT THE TIME OF THE REFERENCED EVENT. UPON RECEIPT OF THE EXPLANTED PROSTHESIS, CO ALSO RECEIVED THE FOLLOWING INFO PROVIDED TO THE OFFICE BY THE PHYSICIAN/SURGEONS OFFICE, IT STATED "INFECTION WAS PRESENT, CULTURE RESULTS INDICATED ESTAFILOCOCUS AUREUS, COAGULASA NEGATIVE". THE PHYSICIAN/SURGEON WAS ASKED IF ANY CIRCUMSTANCES IN THE PT'S HISTORY WHICH COULD HAVE CONTRIBUTED TO THIS OCCURRENCE, HIS RESPONSE INDICATED "AFTER SURGERY THE PT HAD A BAD CICATRIZATION WITH AN INFECTION, WHICH REVEALED CORINE BACTERIUM WHEN CULTURED". THIS INFECTION WAS CONTROLLED WITH CEFALOTINA. THE PT WAS ABLE TO USE THE PROSTHESIS (HE HAD INTERCOURSE NORMALLY). AFTER A FEW WEEKS, THE PAIN CAME BACK AND THE CULTURE RESULTS WERE ESTRAPTOCOCUS AUREUS AND COAGULASA NEGATIVE. FOLLOWING A TELEPHONE CONSULTATION WITH (TWO OTHER PHYSICIAN'S), VANCOMICINIA WAS USED BUT IT WASN'T POSSIBLE TO CONTROL".
EXAMINATION OF THE DEVICE REVEALED NO APPARENT ABNORMALITIES THAT WOULD CONTRIBUTE TO THE REPORT OF INFECTION. HOWEVER, BECAUSE EVALUATION OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORTED INFECTION OR IDENTIFY THE SOURCE, QA ACCEPTS THE PHYSICIAN'S DIAGNOSIS OF THIS AS THE CAUSE FOR MEDICAL INTERVENTION. BASED ON THE PROCEDURES BY WHICH THE DEVICE LOT IS TESTED FOR STERILITY PRIOR TO RELEASE, QA CONCLUDES THAT THIS DEVICE WAS STERILE PRIOR TO OPENING OF THE PACKAGE AND THAT THE INFECTION INITIATED FROM A SOURCE FOR SOURCES OTHER THAN THIS DEVICE.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT (SITE #18) WAS ONE OF 3 PLACED IN CLASS I BONE DURING A ROUTINE PROCEDURE. IT WAS REMOVED 1 MONTH POST-OP. THE CLINICIAN SUSPECTS THAT THE FAILURE WAS DUE TO RESIDUAL BONE PATHOLOGY AT THE SITE (TOOTH WAS EXTRACTED APPROX 4 MONTHS PREVIOUSLY).
APPROX 1 HR INTO DIALYSIS TREATMENT PT C/O CRAMPING. 500 CC NSS AND 40 MEQ HYPERTONIC SALINE GIVEN IV. PT CONTINUED TO CRAMP. ADD'L SALINE AND HYPERTONIC ADMINISTERED. BP STABLE. CHIEF TECH NOTIFIED AND CHECKED MACHINE WHILE IN USE. WATER NOTED ON FLOOR. UF PUMP FILTER TIGHTENED. PT'S SYMPTOMS WORSENED. TREATMENT TERMINATED 20 MINS EARLY. PT RECEIVED TOTAL OF 2000 CC FLUID REPLACEMENT IN ADDITION TO 2 UNITS PRBC'S WHICH WERE PREVIOUSLY ORDERED. PT'S POST WEIGHT WAS 1.5 KG BELOW TARGET AFTER SALINE REPLACEMENT. BP CONTINUED TO BE WITHIN NORMAL LIMITS. PHYSICIAN NOTIFIED. PT INSTRUCTED TO DRINK EXTRA FLUIDS. DISCHARGED TO HOME. PREVENTATIVE MAINTENANCE DONE ON MACHINE 12/22/95. UF PUMP FILTER AND O-RING REPLACED DURING THIS MAINTENANCE. MACHINE PASSED PRESSURE HOLDING TEST PRIOR TO INITIATION OF TREATMENT. AFTER EVENT UF PUMP FILTER (INCLUDING O-RING) REPLACED AGAIN. UF FUNCTIONING PROPERLY.
PT WAS UNABLE TO BE VENTILATED AND WAS TREATED FOR BRONCHO SPASMS. THE DOC WAS ABLE TO VENTILATE PT USING AMBU BAG. AT THAT TIME IT WAS DISCOVERED THAT THE CIRCUIT WAS BLOCKED.
THE REPORTED COMPLAINT OF OCCLUDED ELBOW WAS VERIFIED. IT WAS DETERMINED THAT THIS DEFECT ORIGINATED IN THE MOLD CAVITY FOR THE BREATHING CIRCUIT ELBOW. TO CORRECT THIS PROBLEM CO HAS VOLUNTARILY RECALLED ALL AFFECTED PRODUCT. PRODUCT WILL BE REWORKED AND A NEW ELBOW WILL REPLACE THE AFFECTED ELBOWS. EFFECTIVE IMMEDIATELY ALL BREATHING CIRCUITS WILL BE 100% TESTED FOR FLOW AND LEAKAGE, AS WELL AS IN INCREASED LEVEL OF VISUAL INSPECTION. THE VISUAL INSPECTION INCLUDES USING A PIN GAUGE DESIGNED TO DETECT OCCLUSIONS. IN ADDITION, WE ARE IN THE PROCESS OF MFG A NEW MOLD FOR ELBOW COMPONENT. NO FURTHER INFO IS ANTICIPATED FOR THIS REPORT.
DURING A THROMBECTOMY IN THE FOREARM, THE BALLOON PORTION OF THE CATHETER WAS LEFT IN THE FOREARM. IT WAS EASILY RETRIEVED. NO PATIENT INJURY RESULTED.
F1. USER FACILITYH3. EVALUATION OF PRODUCT INCONCLUSIVE SINCE ONLY CATHETER BODY WAS RETURNED. CATHETER BODY IS IN GOOD CONDITION.
REASON FOR EXPLANT: INFECTION AND PT COMPLAINED THAT PROSTHESIS WOULD INFLATE BY ITSELF".
REPORT FROM FRANCE INDICATES AN INFUSOR CONTAINING 5 FLUOROURACIL OVERINFUSED DURING PT USE. REPORT STATES, "INFUSION WITHIN 18 HRS; DILVENT NACL 0.9%; TOTAL VOLUME 48ML; FLOW RESTRICTOR TAPED ON CHEST." NO FURTHER DETAILS AVAILABLE. NO CLINICAL IMPLICATIONS REPORTED.
SECTION F WAS COMPLETED BY CO BASED ON INFO OBTAINED FROM THE CUSTOMER.
INTUBATED PT, VENTILATOR ALARM DID NOT RING. THIS IS THE SECOND TIME THIS HAS OCCURRED. PT IS OK AS HE WAS CARED FOR IMMEDIATELY. THE KNOB WAS TURNED DOWN YET NURSING NOR RESPIRATORY THERAPY DID NOT TURN. HOSP BIOMED FOUND NO OTHER CONCERN WITH MACHINE.
PER THE INFORMATION PROVIDED TO US BY MEANS OF A USER FACILITY MEDWATCH REPORT, THE FOLLOWING WAS STATED: "REASON FOR EXPLANT: INFECTION AND PATIENT COMPLAINED THAT PROSTHESIS WOULD INFLATE BY ITSELF".
AS IT IS NOT KNOWN TO OUR OFFICE AT THIS TIME IF THE RESERVOIR ONLY WAS REMOVED. ACCORDING TO THE AVAILABLE INFORMATION, THIS PENILE PROSTHESIS WAS IMPLANTED ON 5/17/96. ON 9/17/96 THE DEVICE WAS EXPLANTED REPORTEDLY BECAUSE OF AN "INFECTION AND PATIENT COMPLAINED THAT PROSTHESIS WOULD INFLATE BY ITSELF." INFORMATION RECEIVED BY THE PHYSICIAN'S OFFICE CONFIRMED THAT INFECTION WAS PRESENT AND THAT AUTOINFLATION OF THE DEVICE WAS OBSERVED BY THE PHYSICIAN. THE DEVICE WAS DESTROYED AND THEREFORE NOT RECEIVED BY THE MANUFACTURER. EXAMINATION OF THE DEVICE WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION OR AUTOINFLATION. THEREFORE, QA ACCEPTS THE PHYSICIAN'S DIAGNOSIS THAT INFECTION AND AUTOINFLATION WERE THE CAUSE FOR SURGERY. THE DEVICE LOT HISTORY WAS REVIEWED AND WAS VERIFIED TO HAVE PASSED MANUFACTURING AND QA PROCEDURE REQUIREMENTS FOR RELEASE. BASED ON THIS, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO OPENING OF THE PACKAGE AND THAT THE INFECTION INITIATED FROM A SOURCE OR SOURCES OTHER THAN THE DEVICE. QA ALSO ACCEPTS THE PHYSICIAN'S OBSERVATION OF AUTOINFLATION AS THE REASON FOR REMOVAL.
DURING A GRAFT DECLOTTING PROCEDURE, A BALLOON RUPTURED AND WAS DISLODGED FROM THE TIP OF THE CATHETER. RETRIEVAL WAS NOT SUCCESSFUL. NO PATIENT INJURY HAS BEEN REPORTED AS A RESULT OF THIS EVENT.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. SIX IMPLANTS WERE PLACED IN CLASS IV BONE IN AN ATROPHIC MAXILLA DURING A COMPLEX PROCEDURE ON 7/16/96. THREE OF THE IMPLANTS (#5 AND #14) WERE REMOVED 1 MONTH POST-OP (PLEASE REFER TO MFR REPORT #1222315-1996-00031) DUE TO INSUFFICIENT BONE FOR RETENTION. CLINICIAN REPORTS THAT THE IMPLANT IN SITE #12 WAS REMOVED ON 10/3/96 DUE TO ROOT COMPRESSION OF #11. THE REMAINING IMPLANTS ARE STABLE.
THE DRILL DOES NOT EXIT". THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE EVALUATION RESULTS WOULD SUGGEST THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE BUT RATHER WOULD BE ATTRIBUTED TO USER TECHNIQUE.
SURGEON USING DRILL ON LEFT SIDE OF PT'S FACE. SURGERY WAS BONE GRAFTING FROM HIP TO BILATERAL POSTERIOR MAXILLA AND INTERNAL FIXATION. DRILL BIT SHEARED OFF CUTTING PT'S LIP. SUTURES REQUIRED X2. PT DISCHARGED ON 10/27/96 WITH SMALL LACERATION NOTED HEALING WELL. SECOND DRILL BIT USED; IT ALSO BROKE OFF. ALL PIECES RETAINED.
SURGEON REPORTS A CENTRAL HAZE IN AN IMPLANTED IOL. HE DESCRIBES THIS AS A MILD EVENT WITH NO APPARENT EFFECT ON THE PT. PRE-OPERATIVE VISUAL ACUITY WAS 20/60. CURRENT VISUAL ACUITY IS 20/20/-2.
THIS LENS IS FROM LOT 367744 WHICH WAS RECALLED IN 1995. THE LENS IS STILL IMPLANTED WITH NO INDICATION FROM THE REPORTING SURGEON THAT IT WILL BE EXPLANTED. INFO SUPPLIED IN SECTION F WAS PROVIDED BY THE MFR, NOT THE UF.  THIS REPORT WAS MAILED IN TO FDA ON: 11/15/96. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MDR REQUIREMENT AND SHOULD NO BE CONSIDERED TO BE AN ADMISSION THAT AN CO PRODUCT IS FEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PT AFFECTED 1.
THE DR TRIED TO INSERT THE IAB THROUGH THE SHEATH FOR TEN MINUTES. HE ADJUSTED THE SHEATH BUT THE MEMBRANE "UNCOILED." THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED WITH THE SAME 6" SHEATH WITH A CLEAR HEMOSTASIS VALVE. THE DR HAD DIFFICULTY REMOVING THE IAB BECAUSE THE PT HAD TORTUOUS VESSELS SO THE IAB WAS SURGICALLY REMOVED. (EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 10/29/96.) (PT'S CURRENT STATUS: ALIVE-RPT'D 10/29/96.)
THE IAB WAS RETURNED INTACT FOR EVALUATION WITH THE MEMBRANE NOTED TO BE LOOSELY FOLDED. BLOOD WAS NOTED ON THE EXTERIOR OF THE DEVICE AND WITHIN THE INNER LUMEN. NO KINKS WERE NOTED IN THE CATHETER TUBING. NO SHEATH WAS PRESENT WITH THE IAB CATHETER. THE CATHETER O.D. WAS MEASURED AND FOUND TO BE WITHIN DATASCOPE'S MFG SPECIFICATIONS. WITH A VACUUM DRAWN AND MAINTAINED ON THE LOOSELY FOLDED MEMBRANE, IT WAS NOT POSSIBLE TO INSERT THE IAB THROUGH A LABORATORY 10 FRENCH, 6 INCH SHEATH/HEMOSTASIS VALVE ASSEMBLY (CLEAR) WITHOUT DIFFICULTY. PROBABLE CAUSE OF DIFFICULTY: BASED ON THE EXAMINATION OF THE IAB, IT WAS NOT POSSIBLE TO VERIFY THE ENCOUNTERED DIFFICULTY IN THE LABORATORY. LABORATORY EXAMINATION OF THE RETURNED CATHETER REVEALED NO DEFECTS. HAVING THE OPPORTUNITY TO EXAMINE THE ORIGINAL SHEATH/HEMOSTASIS VALVE ASSEMBLY USED WITH THE BALLOON CATHETER MAY HAVE PROVIDED ADDITIONAL INFO. IN GENERAL, DIFFICULTY ADVANCING THE IAB INTO THE SHEATH/HEMOSTASIS VALVE ASSEMBLY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: THE USER MAY HAVE NOT DRAWN A SUFFICIENT VACUUM ON THE BALLOON DURING ITS REMOVAL FROM THE BLISTER TRAY. IF DRAWN, A VACUUM MAY HAVE NOT BEEN MAINTAINED THROUGHOUT THE INSERTION PROCEDURE. DURING THE INSERTION AND ADVANCEMENT OF THE SHEATH, THE SHEATH MAY HAVE HIT THE OPPOSING WALL OF THE ARTERY CAUSING IT TO KINK. THE PATIENT MAY HAVE HAD A SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO THE SHEATH. THE CATHETER AND/OR INNER LUMEN KINKED DURING INSERTION IF THE BALLOON WAS NOT SUPPORTED BY A GUIDE WIRE. THE CATHETER WAS HELD TOO FAR BACK FROM THE SITE OF INSERTION.
THE JAWS WERE MALIGNED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: EVALUATION RESULTS REVEALED THE THREADED ARM BODY TO BE FRACTURED AND THE DEVICE TO BE USED EXTENSIVELY. THE DEVICE WAS MFR ACCORDING TO SPECIFICATION. A NEW DEVICE HAS BEEN DEVELOPED TO REPLACE THIS INSTRUMENT.
ON 11/9/96 PT WAS DISCHARGED HOME STATUS POST REMOVAL OF BRAIN TUMOR AND PLACEMENT OF VP SHUNT. PT TRANSPORTED BY FAMILY AND PT HAD SEIZURE IN CAR. TAKEN TO ANOTHER MEDICAL FACILITY STABILIZED AND READMITTED HERE FOR REMOVAL OF SHUNT DUE TO INFECTION. NEURO STATUS DETERIORATED ON 11/10/96 AND PT DECLARED BRAINDEAD.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. SIX IMPLANTS WERE PLACED IN CLASS IV BONE DURING A HIGHLY COMPLEX PROCEDURE IN WHICH A SINUS GRAFT WITH SIMULTANEOUS IMPLANT PLACEMENT WAS DONE. IMPLANT IN SITE #3 WAS REMOVED APPROX 6 MONTHS POST-OP. THE PLACEMENT OF THE GRAFT AND IMPLANT WAS DONE AS A 2 STAGE PROCEDURE WHICH LATER DEHISCED. THE CLINICIAN ATTIBUTES THE FAILURE TO THIS, THE 14MM IMPLANT IS NOT A FAILURED IMPLANT. THE CLINICIAN ATTREMPTED TO PLACE IT AT A DIFFERENT SITE AT TIME OF IMPLANT #3 REMOVAL.  THE BONE CRACKED DURING THE ATTEMPT AT PLACEMENT AND THE CLINICIAN SUBSEQUENTLY REMOVED THE IMPLANT.
PER THE INFO PROVIDED TO CO BY THE HOSPITAL, THE DEVICE WAS REMOVED DUE TO "INFECTION". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A CO 3-PIECE INFLATABLE PENILE PROSTHESIS. 10/31/96-UPON RECEIPT OF ADD'L INFO REQUESTED FROM THE PHYSICIAN-SURGEONS OFFICE IT STATED, "THE DEVICE WAS REMOVED DUE TO INFECTION, A SALVAGE PROCEDURE WAS PERFORMED AND A NEW DEVICE WAS IMPLANTED.
EXAMINATON OF THE DEVICE REVEALED NO APPARENT ABNORMALITIES TO CONTRIBUTE TO AN OCCURRENCE OF INFECTION. HOWEVER, BECAUSE EXAMINATION AND TESTING WOULD NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION, QA WILL ACCEPT THE PHYSICIAN'S DIAGNOSIS OF THIS AS THE CAUSE FOR SURGICAL INTERVENTION. BASED ON THE PROCEDURES BY WHICH THIS DEVICE LOT WAS TESTED FOR STERILITY PRIOR TO RELEASE, QA CONCLUDED THAT THE DEVICE WAS STERILE PRIOR TO OPENING OF THE PACKAGE AND THAT THE INFECTION INITIATED FROM A SOURCE OR SOURCES OTHER THAN THE DEVICE.
THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP. THAT "THE JAWS OF THE FORCEPS WAS OR REMAINED GLUED DURING THE SURGERY SO THE SURGERY CHANGED FROM LAPAROSCOPIC TO OPEN SURGERY. THE PHYSICIAN AND THE PATIENT WERE VERY UPSET WITH THIS PROBLEM."
H6; CODE 400: BENT SHAFT & ELECTRODES AND SWOLLEN BILUMIN. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CABLE DAMAGE N/A, ELECTRICAL CONTINUITY N/A, PADDLES FUNCTION PROPERLY N/A, SHAFT ROTATE PROPERLY N/A. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED WITH APPROXIMATELY A 45 DEGREE BENT IN THE SHAFT, WITH BENT ELECTORDE JAWS, WITH PROTEIN MATERIAL INSIDE THE HANDLE, AND WITH THE BILUMIN EXTENDING APPROXIMATELY .500" BEYOND THE DISTAL END OF THE STAINLESS STEEL SHAFT. THE AMOUNT OF PROTEIN INSIDE THE HANDLE AND THE SWOLLEN BILUMIN IS CONSISTENT WITH DEVICES THAT HAVE BEEN SOAKED. NO CONCLUSION COULD BE REACHED AS TO HOW THE SHAFT AND ELECTRODES HAD BECOME BENT. THE DEVICE WAS TESTED FOR ELECTRICAL CONTINUITY AND WAS FOUND TO BE FUNCTIONAL. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.
COMPLAINANT ALLEGED THAT STAFF MEMBERS ATTEMPTED TO DEFIBRILLATE A PT (AGE AND GENDER UNKNOWN) DURING A SURGICAL PROCEDURE. THEY ATTEMPTED TO CHARGE THE UNIT USING INTERNAL PADDLE HANDLES AND THE UNIT WOULD NOT CHARGE. THE STAFF OBTAINED ANOTHER SET OF HANDLES AND TREATED THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT.
ENDOSSEOUS DENTAL IMPLANT REMOVAL. IMPLANT WAS 1 OF 5 PLACED IN CLASS II BONE DURING A ROUTINE PROCURE IN AN ATROPHIC MANDIBLE. THE CLINICIAN REPORTS THAT THE IMPLANT (SITE #9) WAS CLASS II MOBILE AND WOULD TURN WHEN HE ATTEMPTED TO TIGHTEN. THE IMPLANT WAS REMOVED APPROX 1.5 MONTHS POST-OPERATIVELY.
THE MFR HAS EVALUATED THIS EVENT AND CONFIRMED THAT THE LOSS OF INTEGRATION OF ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. MFR'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS PROCEDURE AS PUBLISHED IN THE SCIENTIFIC LITERATURE.
PT HAD MAMMOGRAM AND BREAST BIOPSY 10/95. HAD REPEAT MAMMOGRAM 10/96 WHICH REVEALED ADD'L NODULE AND FOREIGN BODY. SURGERY WAS DONE TO REMOVE DISEASE AND FOREIGN BODY. FOREIGN BODY FOUND TO BE PART OF INNER TUNGSTEN GRASPING SURFACE OF A NEEDLE CARRIER SURGICAL INSTRUMENT.
PER THE INFO PROVIDED BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO "BROKEN TUBING LEADING TO CYLINDER", SECONDARY TO A "MALFUNCTION". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A CO 3-PIECE INFLATABLE PENILE PROSTHESIS.
IN A RETURNED QUESTIONNAIRE, THE PHYSICIAN INDICATED THE FOLLOWING: THERE WAS A SPECIFIC LEAKAGE SITE OBSERVED IN THE "TUBING NEAR PUMP", THE DOCTOR DID NOT NOTICE WHETHER THE TUBING WAS KINKED OR TWISTED AROUND EACH OTHER WHEN HE OPENED THE POCKET, THERE WAS NOTHING NOTED IN THE POSITIONING THAT MAY HAVE CAUSED STRESS(ES) TO THE DEVICE, THE PATIENT HAD A "BACK BRACE", AND THE DEVICE DID CONTACT UNSHOD, SHARP INSTRUMENTATION DURING OR SUBSEQUENT TO REMOVAL, "BUT AFTER TUBING BEAK WAS NOTED." THE ENTIRE DEVICE WAS RECEIVED AND EVALUATED BY THE MFR. DURING FUNCTIONAL TESTING, A LEAK WAS OBSERVED IN THE NON-SERIALIZED PUMP TUBING NEAR THE DISTAL CONNECTOR. GENERAL OBSERVATION, AND MICROSCOPIC EXAMINATION OF THE DEVICE WAS PERFORMED. THE CROSS SECTIONAL SURFACES OF THE SEPARATION SITE WERE ROUGH AND IRREGULAR, INDICATING A TUBING TEAR. THE PUMP'S TUBES WERE RECEIVED OVERLAPPING ONE ANOTHER. ABRASION WAS NOTED ON BOTH TUBES AT THE POINT OF OVERLAP. BASED ON THE RECEIVED INFORMATION AND QUALITY ASSURANCE'S EVALUATION, QA CONCLUDES THE FOLLOWING: THE DEVICE WAS REMOVED DUE TO A TUBING TEAR ON THE SERIALIZED PUMP OUTLET, THE TEAR WAS CAUSED BY STRESS(ES) EXPERIENCED BY THE DEVICE WHILE IN-VIVO, AND THE STRESS(ES) WERE CONTRIBUTED TO BY THE DEVICE'S POSITIONING WHILE IN-VIVO.
THE SPRING WAS LOST DURING CLEANING. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THEREFORE THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
SUMMARY OF EVALUATION: THE ROOT CAUSE IS ATTRIBUTED TO THE USER LOSING THE COIL SPRING. THE AGENT WILL REORDER SPRING AS REPLACABLE PART.
THE SWITCH EMITTED SPARKS. CO INSPECTION REVEALED THE CUSTOMER HAD ALTERED THE PRODUCT BY TAPING DOWN THE SWITCH WHICH IS CONTRARY TO CO'S INSTRUCTIONS. THE ELECTRIC CORD WAS CUT, RESOLDERED AND THEN TAPED. NO DEATHS OR INJURIES WERE REPORTED.
ANGIOPLASTY BALLOON FAILED TO DEFLATE. SHAFT OF BALLOON CUT BY PHYSICIAN AND BALLOON THEN ABLE TO BE REMOVED FROM CORONARY ARTERY.
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. TWO IMPLANTS WERE PLACED IN CLASS II BONE IN A COMPLEX PROCEDURE REQUIREING BONE AUGMENTATION DUE TO A BUCCAL DEHISCENCE. IMPLANT IN SITE #3 WAS REMOVED 1 MONTH POST-OP. THE CLINICIAN BELIEVES THAT A POST-OPERATIVE INFECTION OF THE GRAFT SITE WAS THE CAUSE OF IMPLANT FAILURE.
WHEN THE IAB WAS INSERTED INTO THE PT, THE IAB DID NOT FULLY OPEN. THE  BALLOON WAS CHECKED UNDER FLUOROSCOPY AND WAS MANUALLY OPENED WITH 60CC SYRINGE, BUT THE IAB STILL WOULD NOT FULLY OPEN. THE IAB WAS REMOVED AND A SECOND WAS INSERTED. AS A RESULT OF THE EVENT, THERE WAS EXCESSIVE BLEEDING WHEN THE IAB WAS REMOVED. (EVENT COMPLICATIONS: EXCESSIVE BLEEDING FROM INSERTION SITE-) RPT'D 10/29/96. (PT'S CURRENT STATUS: UNK-RPT'D 10/29/96.
A PARTIAL IAB, CONSISTING OF THE IAB MEMBRANE AND A PORTION OF ATTACHED CATHETER TUBING WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION REVEALED THAT THE MEMBRANE WAS COMPLETELY UNFOLDED. IT WAS NOT POSSIBLE TO SATISFACTORILY PUMP THE BALLOON ON THE LABORATORY SYSTEM 90 IABP DUE TO THE CONDITION OF THE RETURNED MEMBRANE AND CATHETER TUBING. PROBABLE CAUSE OF DIFFICULTY: BASED ON THE CONDITION OF THE IAB, IT WAS NOT POSSIBLE TO SATISFACTORILY EXAMINE THE BALLOON TO DETETMINE WHY IT WOULD NOT INFLATE OR TO VERIFY THE REPORTED DIFFICULTY. IN GENERAL, AUGMENTATION AND INFLATION DIFFICULTIES MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: 1. THE BALLOON WAS PLACED SUBINTIMALLY. 2. THE BALLOON WAS PLACED TOO HIGH IN THE AORTIC ARCH OR IN THE SUBCLAVIAN ARTERY. 3. THE PROXIMAL PORTION OF THE MEMBRANE REMAINED WITHIN THE SHEATH. 4. THE IAB FAILED TO COMPLETELY UNFOLD BECAUSE THE USER FAILED TO INJECT AT LEAST 30CC OF AIR AS ADVISED IN THE INSTRUCTIONS FOR USE. 5. THE CATHETER KINKED WITHIN THE PATIENT, POSSIBLY DUE TO SEVERE VESSEL TORTUOSITY AND/OR PATIENT MOVEMENT. 6. THE CATHETER KINKED OUTSIDE THE PATIENT. THE USER MAY HAVE FAILED TO SECURE THE CATHETER AND Y-FITTING TO THE PATIENT. MANIPULATION OF THE KINKED PORTION OF THE CATHETER COULD HAVE MINIMIZED THE RESTRICTION AND IMPROVED BALLOON PERFORMANCE. HAVING THE OPPORTUNITY TO EXAMINE A COMPLETELY OR LOOSELY FOLDED MEMBRANE MAY HAVE PROVIDED SOME ADDITIONAL INFO INTO THE REPORTED PROBLEM. SINCE THE MEMBRANE WAS RETURNED WITH THE MEMBRANE UNFOLDED, IT IS POSSIBLE THAT THE MEMBRANE WAS EXAMINED AT THE FACILITY PRIOR TO ITS RETURN TO DATASCOPE FOR EVALUATION.
WHILE STOCKING THE LOANER SET, IT WAS NOTICED THAT THE 28MM + 12MM HEADS WERE RED IN COLOR. ALL OTHER + 12MM INSTRUMENTS WERE BROWN. THE RED COLORED INSTRUMENTS CORRESPOND TO THE 16MM TRIAL HEADS. THIS EVENT WAS NOTICED AT THE SALES AGENCY AND THE CASE WAS NOT SENT TO THE HOSP. THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.
THE RESULTS OF THE INVESTIGATION INDICATE THE INCORRECT COLOR MATERIAL WAS USED ON ONE ORDER OF PRODUCT. ALL MARKINGS ON THE PRODUCT WERE CORRECT PER THE CATALOG NUMBER. THE PRODUCT WAS NOT DISTRIBUTED TO ANY HOSPITALS. CORRECTIVE ACTION WAS IMPLEMENTED TO PRECLUDE SIMILAR OCCURRENCES.
THE UNIT BURNED. CO'S INSPECTION REVEALED A 3/8" DIAMETER BURN HOLE THROUGH THE PAD. NO DEATHS OR INJURIES WERE REPORTED. THE MALFUNCTION AROSE FROM THE USE OF HEATER WIRE CONTAINING A FIBERGLASS COATING. USE OF THIS HEATER WIRE WAS DICTATED BY THE REGULATORY AGENCY UNDER WHICH CO'S PRODUCT IS MANUFACTURED. SUBSEQUENTLY, CO WAS ALLOWED TO MODIFY THE MANUFACTURING PROCESS TO INCLUDE A SUPERIOR WIRE THAT ELIMINATES THE PROBLEMS REPORTED HEREIN. REMEDIAL ACTION HAS BEEN ACCOMPLISHED.
AN ELECTROCAUTERY HOOK CAUSED A MINOR BURN DURING A ENDOMETRIOSIS CASE DUE  TO A TEAR IN THE CAUTERY INSULATION. THE CAUTERY FIRED AT A LOCATION OTHER THAN INTENDED. NO SURGICAL INTERVENTION WAS REQUIRED AND PT RECOVERED COMPLETELY. POSSIBILITY OF SERIOUS INJURY WAS PRESENT.
THE PT UNDERWENT THE VS PROCEDURE AT 10.2 WEEKS GESTATION. ONE TRANSCERVICAL PASS WAS MADE. THE PT DID NOT HAVE ANY PROBLEMS POST PROCEDURE. AT APPROX. 12 WEEKS GASTATION, THE PT EXPERIENCED HEAVY BLEEDING AND SPONTANEOUSLY ABORTED. THE FETUS WAS REPORTEDLY A GENETICALLY NORMAL MALE. A D&C WAS PERFORMED.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FDA BY CO PURSUANT TO 21 C.F.R. PART 803, AND THE PUBLIC RELEASE OF SUCH INFO DOES NOT CONSTITUTE AN ADMISSION BY THE CO THAT A CO DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN CO'S DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. DATE LISTED IS THE DATE OF THE CVS PROCEDURE. METHOD, CODE 86, OTHER: THIS DEVICE IS EVALUATED ANNUALLY BY CO  AS A REQUIREMENT OF THE PMA AND REPORTED TO THE OFFICE OF DEVICE EVALUATIONS. RESULTS, DEVICE, CODE 100, OTHER: SPONTANEOUS ABORTION IS A POTENTIAL ADVERSE EVENT LISTED IN PRODUCT LABELING. CONCLUSION, CODE 68M OTHER: CO'S LAST ANNUAL REPORT, WHICH COVERED THE PERIOD OF 10/1/94 TO 9/30/95, REVEALED THAT THE FETAL LOSS RATE IS LESS THAN INDICATED IN THE  INITIAL PMA SUBMISSION. A SIMILAR REVIEW WILL BE CONDUCTED FOR THE CURRENT PERIOD AND REPORTED TO THE OFFICE OF DEVICE EVALUATIONS.
PHYSICIAN WAS REMOVING SIX EPILEPSY ELECTRODE STRIPS AT BEDSIDE INSTEAD OF IN THE OPERATING ROOM. CONTACTS CAME OFF THREE OF THE STRIPS. ON ONE OF THE STRIPS AN ESP-6, ALL CONTACTS CAME OFF THE STRIP. ANOTHER ESP-6 STRIP ONE CONTACT CAME OFF THE STRIP. AND ON ONE ESP-8 ELECTRODE STRIP ONE CONTACT CAME OFF THE STRIP. MEDICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE CONTACTS.
THIS REPORT IS BASED ON INFO SUPPLIED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT OR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY CO DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY HAS OCCURRED; OR THAT ANY CO DEVICE CONTRIBUTED TO OR IS LIKELY TO CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THE 15MM CONNECTOR STEM BROKE WHEN THE DOCTOR WAS ATTEMPTING TO REMOVE THE TRACHEAL TUBE FROM AN IN-LINE SUCTION SYSTEM. THE FACILITY STATED THAT EXTREME FORCE WAS USED TO DISCONNECT THE TWO DEVICES.THE USER FACILITY STATED THAT THE LENGTH OF USE OF EITHER DEVICE WAS UNKNOWN; HOWEVER, IT IS HOSPITAL POLICY TO REPLACE THE SUCTION SYSTEM EVERY 24 HOURS. IT IS UNKNOWN WHETHER THIS EVENT OCCURRED DURING THE FIRST USE OF THE SUCTION SYSTEM OR IF PREVIOUS SYSTEMS HAD BEEN ATTACHED AND DETACHED TO THE SAME TUBE. IT IS UNKNOWN HOW LONG THE INCIDENT SUCTION SYSTEM HAD BEEN ATTACHED.
EVALUATION: DEVICE WAS VISUALLY INSPECTED. CONFIRMED THAT 15MM CONNECTOR STEM WAS SEVERED AT BASE OF CONNECTOR. CONSISTENT WITH FACILITY CLAIM OF EXERTING EXTREME FORCE IN DISCONNECTION.IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NOIS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? NOIS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NOIS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NOTHIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT CO.'S DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT THE A DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
THE LEAD WAS EXPLANTED ELECTIVELY. FAILURE ANALYSIS INDICATES THE LEAD IS FRACTURED WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.
THIS ENTIRE FORM COMPLETED BY MFR. VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED 5MM, 10MM, 22MM, 27MM AND 33MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 54MM AND HAS MIGRATED DOWN LEAD BODY 67MM PROXIMAL OF WELD SITE. IT APPEARS THAT THE ENTIRE J STIFFENER WIRE WAS REC'D WITH ALL RECORDED MEASUREMENTS ADDING UP TO 87MM. X-RAY OF LEAD DISTALLY CONFIRMS J STIFFENER WIRE FRACTURES.
INDUCTION OF ANESTHESIA. #5 LMA PLACED UNDER DIRECT MANIPULATION; ATTEMPTED VENTILATION; SIGNIFICANT LEAK NOTED AT 12-15 ML H2O; ATTEMPTED REPOSITION; PERSISTENT LEAK. DEFLATED CUFF, REMOVED STEM/TUBE ONLY; COMPLETE FRACUTRE NOTED. ATTEMPTED REMOVAL OF PHALANGE VIA PILOT BALLOON; AGAIN BROKE OFF OF DIAPHRAGM. ATTEMPTED DIRECT REMOVAL WITH HEMOSTAT WITH FRAGMENTS REMOVED ONLY. DIRECT LARYNGOSCOPY; DISTAL PORTION OF TUBE NOTED TO BE BEHIND SOFT PALATE. DISTAL TUBE AND DIAPHRAGM REMOVED WITH HEMOSTAT UNDER DIRECT LARYNGOSCOPY.
THE MD'S PT RECEIVED A SECOND DEGREE BURN WHILE THE MD WAS CONDUCTING A NERVE CONDUCTION STUDY ON A PT WITH DIABETES WITH NEUROPATHY. CORRESPONDENCE WITH THE MD REVEALED HE HAD TAPED DOWN THE SWITCH AND TOLD THE PT TO REMOVE THE PAD WHEN IT GOT TOO HOT. HE HAD LEFT THE PT UNSUPERVISED IN THE ROOM WHILE THE TREATMENT WAS BEING ADMINISTERED. CO'S INVESTIGATION REVEALED NO DEFECT WAS FOUND WITH THE UNIT. THE HEAT RISE TEST WAS WITHIN THE NORMAL RANGE. CO'S INSTRUCTION BOOKLET AND THE UNIT'S ATTACHED LABEL CLEARLY STATE NOT USE THIS UNIT ON PERSONS WITH INSENSITIVE SKIN AND PERSONS WITH POOR CIRCULATION. "PERSONS WITH DIABETES SHOULD BE ESPECIALLY CAREFUL WHEN APPLYING HEAT." THE BOOKLET HAS A "WARNING: THE SWITCH WAS DESIGNED FOR YOUR SAFETY. USE ONLY AS DIRECTED. PRESS THE SWITCH "ON" AND HOLD IT THERE. THE SWITCH IS SPRING-LOADED SO THE PACK IS "OFF" IF THE SWITCH ISN'T HOLD "ON". WHEN THE PACK GETS AS HOT AS YOU CAN TOLERATE, RELEASE THE SWITCH AND LET IT COOL FOR A FEW MINUTES. YOU CONTROL THE HEAT BY HOLDING THE SWITCH IN YOUR HAND. PLEASE DO NOT SWITCH IT "ON" ANY OTHER WAY. IT FURTHER STATES THAT THE UNIT SHOULD NOT BE USED AS A FOOT WARMER, SINCE IT GETS TOO HOT FOR THIS PURPOSE. NO DEATHS OR SERIOUS INJURIES WERE REPORTED. CO'S INVESTIGATION CONCLUDES THAT LACK OF ATTENTION TO THE WARNING LABEL AND INSTRUCTION BOOKLET CONTRIBUTED DIRECTLY TO THE REPORTED INCIDENT.
KNEE JOINT "SHIFTED" AND HAD LESS RANGE OF MOTION. AT SURGERY, WASHERS WERE NOTED TO BE LOOSE. WASHERS WERE REPLACED AND PROSTHESIS WAS REPOSITIONED. KNEE PROSTHESIS HAD BEEN INSERTED ON 8/12/96.
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES J STIFFENER WIRE HAS FRACTURED 33MM PROXIMAL OF WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES 55MM AND HAS MIGRATED DOWN THE LEAD BODY 18MM PROXIMAL WELD SITE. 1 MM OF THE PROXIMAL END OF THE J STIFFENER WIRE WHICH FRACTURED 33MM PROXIMAL OF THE WELD SITE AND REMAINS ATTACHED AT THE WELD SITE WAS RECEIVED PROTRUDING OUT OF THE OUTER POLYURETHANE INSULATION. IT APPEARS THE ENTIER J STIFFENER WIRE WAS RECEIVED WITH ALL RECORDED ADD UP TO 88MM.
WHEN THE UNIT WAS TURNED ON, PRIOR TO BEING USED ON A PT. SPARKS CAME FROM THE UNIT. THE SPARKS DID NOT CAUSE ANY INJURIES OR DAMAGE.
D.6) LOT#09696. 193842.S656 H. METHOD-DEVICE WAS NOT RETURNED FOR EVAL. SUMMARY. NO PRODUCT WAS RETURNED FOR EVAL. FROM THE AVAILABLE INFO, THE FITTING OF THE CATHETER WAS STRETCHED OUT OF SHAPE BY ANOTHER MFR'S FITTING. WHEN THE OTHER MFR'S FITTING WAS REMOVED AND REPLACED WITH YET ANOTHER FITTING, LEAKAGE OCCURRED. THE AREA SALES REP HAS BEEN IN CONTACT WITH THE CUSTOMER AND SUGGESTED THE USE OF CO CATHETERS WITH THE MDA SUFFIX WHICH MAY BE BETTER SUITED TO THEIR NEEDS.
THE IAB WAS INSERTED INTO THE PT ON 10/14/96. ON 10/16/96 AFTER IABP FOR 40 HRS, BLOOD WAS NOTED IN THE EXTENDER TUBING AND THE SAFETY CHAMBER. THE "GAS LOSS" ALARM SOUNDED DURING IABP. WHEN THE IAB WS REMOVED, THERE INJURY TO THE PT'S ARTERY. THERE WERE NO FURTHER COMPLICATIONS AND THE PT IS CUURENTLY O.K. (EVENT COMPLICATIONS: THERE WAS INJURY TO THE PT'S ARTERY)-RPT'D 10/25/96. (PT'S CURRENT STATUS: O.K.-RPT'D 10/25/96.)
UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICLA OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.
THE DEVICE WAS APPLIED DURING A HYSTERECTOMY PROCEDURE. THE CLIPS DID NOT FORM PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/18/96- MEDWATCH REPORT WAS NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
ENBDOSSEOUS IMPLANT REMOVAL. IMPLANTS WERE 5 OF 7 PLACED IN A HIGHLY COMPLEX PROCEDURE IN CLASS II BONE. THE PROCEDURE WAS DIFFICULT BECAUSE THE PT WAS UNABLE TO OPEN HIS MOUTH AND THE POSTERIOR AREAS WERE CLOSE TO THE NERVES. THE IMPLANTS WERE REMOVED APPROX 1 MONTH POST-OPERATIVELY DUE TO NUMBNESS.
ON 8/6/1996, THE MANUFACTURER RECEIVED A REPORT FROM ITS DISTRIBUTOR THAT STATES THEY RECEIVED AN EMPTY PACKAGE, WHICH SHOULD HAVE CONTAINED A NEEDLE.
THE DEVICE WAS RETURNED TO THE MFR ON 8/16/96, AND THE RESULTS OF THE DEVICE EVALUATION ARE AS FOLLOWS: VISUAL EXAMINATION CONFIRMED THE CUSTOMER'S COMPLAINT OF "MISSING NEEDLE". THE DEVICE POUCH WAS SEALED 100% ALL AROUND THE PACKAGE AND THE DEVICE SHEATH WAS ENCLOSED IN THE SEALED POUCH. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER AND DID NOT REVEAL ANY TRENDS. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THIS EVENT OCCURRED DURING PRODUCT ASSEMBLY. THE MFR HAS CHANGED TO A NEW VENDOR AND NEEDLE DESIGN FOR THIS PRODUCT ASSEMBLY. THE MFR HAS CHANGED TO A NEW VENDOR AND NEEDLE DESIGN FOR THIS PRODUCT NUMBER. THE MFR HAS DISCONTINUED PURCHASING FROM THE VENDOR WHO SUPPLIED THE PRODUCT ON THIS INCIDENT. NO FURTHER INFORMATION IS AVAILABLE.  H11- THE MFR INITIALLY REPORTED THAT THE DEVICE WAS RETURNED ON 8/14/96, UNDER D9; HOWEVER, UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT THE PRODUCT WAS RETURNED ON 8/16/96. THIS FILE IS NOW BEING CLOSED.
PHYSICIAN INSERTING CATHETER; TUNNELING IT IN UNDER SKIN UNDER NORMAL PRESSURE. CATHETER BROKE APART INTO TWO PIECES. PHYSICIAN REMOVED CATHETER AND INSERTED ANOTHER WITHOUT PROBLEMS. UPON MANIPULATING THE CATHETER AFTR REMOVAL, PHYSICIAN NOTED THAT IT BROKE APART MUCH EASIER THAN IT SHOULD UNDER NORMAL PRESSURE.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP THAT THE STAPLE FELL OUT. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B3,6,7,D10: INFO NOT SUPPLIED BY AFFILIATE. D5, 6; H4,6: INO UNAVAILABLE, DEVICE NOT RETURNED FOR EVAL.
SURGICAL INTERVENTION ON 10/16/96 TO REMOVE FRACTURED FINGER JOINT IMPLANT, INITIALLY PLACED IN PT ON 8/15/96.
THE REPORTED EVENT HAS NOT OCCURRED MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. 11/15/96 AWAITING ADD'L INFO AND HISTORY FROM INITIAL REPORTER. INVESTIGATION IS CURRENTLY ONGOING WITH NO CONCLUSIONS MADE AT THIS TIME. WILL FORWARD FINAL REPORT UPON COMPLETION OF INVESTIGATION.
H.6) RESULTS-SEE ATTACHED EVALUATION SUMMARY. CONCLUSIONS-SEE ATTACHED EVAL. SUMMARY. THE RETURNED USED AND UNUSED CATHETERS WERE EXAMINED AND FOUND TO HAVE BEEN MANUFACTURED ACCORDING TO SPECIFICATIONS. HOWEVER, CO DOES CONFIRM SEPARATION OF THE RETURNED USED CATHETER. NO UNUSUAL CHARACTERISTICS OF THE CATHETER MATERIAL WERE NOTED. IT APPEARS THE DEVICE HAS ENCOUNTERED RESISTANCE BEYOND ITS STRENGTH DURING ATTEMPTED PLACEMENT.
DEVICE LABEL CODE: 1701. EVALUATION SUMMARY: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECTED TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY. THE PHYSICAL EVIDENCE AND REPORTED PROBLEM ARE CONSISTENT WITH THAT OF AN IAB WHICH BECAME ENTRAPPED AND WAS SURGICALLY REMOVED FROM THE PATIENT. THE SMOOTH-EDGED PENETRATION(S) MOST LIKELY RESULTED WHEN THE BALLOON MEMBRANE CAME IN CONTACT WITH A SHARP-EDGED INSTRUMENT DURING THE REMOVAL PROCESS. ALTHOUGH THE PATIENT CONSEQUENCES OF BALLOON PENETRATION REMAIN OVERWHELMINGLY BENIGN, GENERALLY NECESSITATING ONLY THE REMOVAL OF THE BALLOON AND ITS POSSIBLE REPLACEMENT, THE MEDICAL COMMUNITY IS BECOMING INCREASINGLY AWARE OF THE "ENTRAPPED BALLOON" PHENOMENON. SINCE IT IS POSSIBLE FOR A SMALL LEAK TO BE SELF LIMITING, THE BLOOD WITHIN THE BALLOON MAY DEHYDRATE UNDER THE CONTINUED ACTION OF HELIUM TO FORM A HARD CLOT DURING INTRA-AORTIC BALLOON PUMPING, BEFORE ENOUGH BLOOD ENTERS TO BECOME VISIBLE TO THE CATHETER. THIS CLOT MAY PREVENT PERCUTANEOUS REMOVAL OF THE BALLOON CAUSING IT TO BECOME "ENTRAPPED" IN THE ARTERY. BALLOON ENTRAPMENT NECESSITATING SURGICAL REMOVAL HAS BEEN REPORTED IN LITERATURE AND HAS BEEN EXPERIENCED BY USERS OF INTRA-AORTIC BALLOONS. CO THEREFORE URGE THE USER, AS CO HAS DONE IN CO'S INSTRUCTIONS, TO DISCONTINUE PUMPING AND CONSIDER THE REMOVAL OF THE BALLOON FROM THE PATIENT AT ONCE IF A BALLOON LEAK IS SUSPECTED. IF FOR ANY REASON, UNDUE RESISTANCE IS MET DURING REMOVAL OF THE BALLOON, THE USER WOULD BE WELL ADVISED TO CALL FOR A VASCULAR CONSULTATION, AS WAS DONE IN THIS CASE.
AS A RESULT OF THE EVENT, THE BALLOON BECAME ENTRAPPED AND A THROMBECTOMY AND ARTERIOTOMY WERE PERFORMED TO REMOVE THE IAB. CURRENTLY, THE PATIENT IS HEMODYNAMICALLY UNSTABLE WITH MASSIVE BLOOD LOSS. EVENT COMPLICATIONS: UNK - RPT'D 10/22; ENTRAPMENT/THROMBOLECT'Y/ANTERIOTOMY - RPT'D 10/24.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. THE NATURE OF THE DIFFICULTY IS UNKNOWN. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B3,6,7; D10; INFO UNAVAILABLE. SEE CORRESPONDENCE LOG. 10/21/96 1500 SPOKE TO SURGEON WHO STATED HE USED THE DEVICE DURING A LAP CHOLE. THE SURGEON COULD NOT RECALL THE SPECIFIC DIFFICULTY, BUT REMEMBERED DEVICE WAS SPITTING OUT CLIPS. HE WAS ABLE TO RETRIEVE THE CLIPS AND COMPLETE THE PROCEDURE WITH ANOTHER, SAME MODEL.  HE STATED THERE WAS NO CONSEQUENCE TO PT. D5;H4,6: INFO ANTICIPATED. BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAM, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT CYCLED, FED, AND FORMED CLIPS WITHIN DESIGN SPEC WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE ITS PRODUCTS.
SUMMONS & COMPLAINT RECEIVED ALLEGING TSS
510K#950928 1 PERSON SERIOUS INJURY TYPE G
THERE WAS NO WHITE HEMOSTASIS VALVE FOUND ON THE INTRODUCER SHEATH/HEMOSTASIS VALVE ASSEMBLY. THERE WAS PROFUSE BLEEDING AFTER INSERTION DUE TO THE ABSENCE OF THE VALVE. EVENT COMPLICATIONS: (PROFUSE BLEEDING REPORTED 10/24/96). PT'S CURRENT STATUS: UNK. REPORTED 10/24/96.
A WHITE, 10 FRENCH, 6 INCH SHEATH/HEMOSTASIS VALVE ASSEMBLY WAS RETURNED FOR EVALUATION WITH BLOOD NOTED ON THE EXTERIOR OF THE DEVICE. VISUAL EXAMINATION REVEALED THAT THE WHITE RUBBER DIAPHRAGM WAS SEATED PROPERLY WITHIN THE HEMOSTASIS CAP AND BODY. IT WAS POSSIBLE TO PASS A FOLDED LABORATORY IAB THROUGH THE RETURNED ASSEMBLY WITHOUT DIFFICULTY. LABORATORY TESTING DID REVEAL THAT THE VALVE PREVENTED THE BACK-FLOW OF WATER WHEN A LABORATORY CATHETER WAS IN PLACE THROUGH THE ASSEMBLY. NO LEAKS WERE FOUND IN THE DEVICE. PROBABLE CAUSE OF DIFFICULTY: IT WAS REPORTED THAT NO VALVE WAS PRESENT ON THE SHEATH YET A HEMOSTASIS VALVE WAS RETURNED FOR EVALUATION. BASED ON THE EXAMINATION OF THE RETURNED VALVE, NO DEFECT WAS FOUND IN THE DEVICE. ALTHOUGH CONJECTURAL, IT IS POSSIBLE THAT THE VALVE WAS NOT TIGHTLY SECURED TO THE SHEATH HUB. IF THIS WAS THE CASE, EXCESSIVE BLEEDING WOULD ALSO HAVE RESULTED.
THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC LYSIS OF ADHESIONS AND EXCISION OF ENDOMETRIOSIS. THE 5 MM DISSECTING HOOK WAS USED NEAR THE PERITONEAL REFLECTION/RECTAL SIGMOID JUNCTION WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED AS EXPECTED. ON THURSDAY, 11/17, PT PRESENTED IN ER FEBRILE WITH VOMITING. EXPLORATORY LAPAROTOMY PERFORMED-FOUND DEFECT IN RECTUM BELOW SIGMOID COLON. THIS LESION WAS OVERSEWED. PT REPORTEDLY STILL HOSPITALIZED, BUT DOING WELL. REP REPORTS THE INSTRUMENT IS NOT BEING NAMED AS PROBLEMATIC DURING INITIAL PROCEDURE. 10/22/96, REP REPORTED PT STILL HOSPITALIZED, BUT DOING WELL.
THE FILTER WOULD NOT RELEASE FROM THE POD.
ON 6/3/96 PT HAD A DENTAL VENOUS LINE INSERTED IN HIS RIGHT SUBCLAVIAN VEIN. PT WAS DISHCARGED ON 6/6/96 WITH HOME HEALTH, WHO USED ANOTHER CO'S CONNECTOR WITH THE CATHETER. ON 7/19/96 THE PT WAS ADMITTED TO THE HOSPITAL FOR BRAIN SURGERY. THE SITE VALVE WAS USED. THESE TWO PRODUCTS WERE UNDERSTOOD TO BE INTERCHANGEABLE WHEN USED WITH THE CO CATHETER, HOWEVER, IT APPEARS THE OTHER CO'S CONNECTOR STRETCHED THE CATHETER CAUSING A LEAKAGE TO OCCUR AT THE LOCK CAP WHEN THE SITE VALVE WAS USED. ON 8/1/96 THE PT GREW COAGULASE NEGATIVE STAPHYLOCOCCUS FROM THE CENTRAL VENOUS CATHETER. THE PT WAS GIVEN A 7 DAY COURSE OF ANTIBIOTICS AND THE INFECTION SUBSEQUENTLY CLEARED AT THAT TIME.
THE UNIT GAVE RPTR'S WIFE A SMALL SHOCK AND THEN STOPPED WORKING. NO INJURY OCCURRED.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. THE CLIPS WERE FALLING OUT. NO CONSEQUENCE TO PT.
A1,2,3,4; B3, 6,7, D10: INFO NOT SUPPLIED BY AFFILAITE. D5,6; H4,6: INFO UNAVAILABLE, DEVICE NOT RETURNED.
D.5) UNABLE TO DETERMINE WITHOUT LOT # INFO. 6) LOT# THE NUMBER GIVEN IS AN INCOMPLETE LOT NUMBER. F.9) UNABLE TO DETERMINE WITHOUT LOT  INFO. H.4) UNABLE TO DETERMINE WITHOUT LOT # INFO 6) METHOD-DEVICE WAS NOT RETURNED FOR EVAL. CONCLUSIONS-SEE ATTACHED EVALUATION SUMMARY. NO PRODUCTS WAS RETURNED FOR EVAL. FROM THE AVAILABLE INFO, THE FITTING OF THE CATHETER WAS STRETCHED OUT OF SHAPE BY ANOTHER MFR'S FITTING. WHEN THE OTHER MFR'S FITTING WAS REMOVED AND REPLACED WITH YET ANOTHER FITTING, LEAKAGE OCCURRED. THE AREA SALES REP HAS BEEN IN CONTACT WITH THE CUSTOMER AND SUGGESTED THE USE OF CO CATHETERS WITH THE MDA SUFFIX WHICH MAY BE BETTER SUITED TO THEIR NEEDS.
WHILE PERFORMING A FEMORAL APPROACH, THE SHEATH KINKED. THIS PREVENTED THE FILTER FROM ADVANCING.
ON INFLATION TO DEPLOY STENT, BALLOON RUPTURED AT APPROX 4 ATMS. GUIDING CATHETER AND STENT BALLOON WITHDRAWN, STENT WAS NOT ON BALLOON. EVENTUALLY REMOVED. MFR REP NOTIFIED AT TIME OF PROCEDURE AND TOOK INVOLVED STENTS.
ON RELEASE OF VACUUM EXTRACTOR NOTED 8 CM CIRCULAR ABRASION AREA UPPER FOREHEAD AND SCALP WITH REMOVAL OF LARGE AMOUNT EPIDERMUS WITH CEPHALHEMATOMA, DEVIATED NASAL SEPTUM, AND SUBDURAL HEMATOMA.
COULD NOT ADVANCE THE FILTER INTO THE INTRODUCER CATHETER.
FULL EVALUATION WAS NOT POSSIBLE SINCE DELIVERY SYSTEM WAS RETURNED WITHOUT A FILTER.
PT USING BESIDE COMMODE SUSTAINED ABRASIONS TO LEG FROM TWO SHARP RODS HOLDING CONTAINER FOR EXCRETA. BACITRACIN APPLIED TO WOUNDS.
THE DEVICE WAS APPLIED DURING A BIOPSY. THE INSTRUMENT DID NOT CUT. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/18/96- MEDWATCH NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
THE CATHETER WAS PLACED ON 10/18/96 AS A MIDLINE AFTER BEING CUT TO 9 INCHES. THE PT WAS AT HOME AND THE CATHETER WAS BEING FLUSHED BY THE PT'S WIFE, WHEN IT SEPARATED. THE SEPARATED PORTION OF THE CATHETER WAS REMOVED FROM THE PT ON 10/22/96 VIA HIS FEMORAL ARTERY. THERE WERE NO ADD'L PT COMPLICATIONS.
THE CATHETER WAS PLACED ON 10/18/96 AS A MIDLINE AFTER BEING CUT TO 9 INCHES. THE PT WAS AT HOME AND THE CATHETER WAS BEING FLUSHED BY THE PT'S WIFE, WHEN IT SEPARATED. THE SEPARATED PORTION OF THE CATHETER WAS REMOVED FORM THE PT ON 10/22/96 VIA HIS FEMORAL ARTERY. THERE WERE NO COMPLICATIONS.
THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION PROCEDURE. THE STAPLE LINE WAS INCOMPLETE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED THAT NO PT INJURY OCCURRED.
9/18/96- MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMITTED INITIAL REPORT.
ON 10/2/96, PT EXPERIENCED RED EYE AND FOREIGN BODY SENSATION IN RIGHT EYE. DR ADMINISTERED CILOXAN AND PT HAS RESUMED CONTACT LENS WEAR. LENS MODEL/WATER CONTENT: DEVICES 55%; LOT NUMBER: 6109295; EYE INVOLVED: RIGHT 8/5/00; REFRACTION: MYOPIA; TOTAL DURATION OF USE (IN MONTHS): 46; NUMBER DAYS LENS WORN: 7; LAST VISIT TO DR PRIOR TO SYMPTOMS: 11/95 LENS CARE SYSTEM USED: NONE; DISINFECTION SYSTEM USED; NONE; WAS HOMEMADE SALINE USED; NO DAY LENS WORN BETWEEN CLEANING AND DISINFECTING: NONE; DAYS LENS WORN BETWEEN CLEANING AND SYMPTOMS: NONE; DAYS BETWEEN SYMPTOMS AND CALLING DR: SAME DAY; SELF TREATMENT BY PT: NO; HAND WASHING BEFORE LENS MANIPULATION: YES; ULCER LOCATION:8:00; VISUAL ACUITY BEFORE SYMPTOMS: 20/20; VISUAL, ACUITY AFTER SYMTPMS: 20/20; RESULTS OF CULTURE: NONE TAKEN; RESULTS OF CORNEAL BIOPSY AND/OR SCRAPINGS: NONE; TREATMENT ADMINISTERED: CILOXAN.
ADDITIONAL INFO SUBMITTED? NO. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO IF "N", IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL? NO IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO IF "N", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO
TRACH TUBE WAS PLACED AND DIFFICULTY WAS ALLEGEDLY ENCOUNTERED VENTILATING THE PT. USING A BRONCHOSCOPE, THE CLINICIAN REPORTEDLY SAW PT TISSUE AT OR NEAR THE TIP OF THE TUBE. THE CLINICIAN STATED THAT HE HAD OR MAY HAVE INTUBATED THE RIGHT MAINSTEM BRONCHUS. THERE WAS NO REPORTED PT INJURY AS A RESULT OF THIS EVENT.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FDA BY CO PURSUANT TO 21 CFR PART 803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AN ADMISSION BY THE CO THAT CO'S DEVICE HAS MALFUNCTIONED, NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN CO'S DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. ANI ENTRY THROUGHOUT THE FORM; CO HAS CONTACTED THE USER FACILITY REQUESTING A SITE VISIT TO FURTHER DISCUSS AND INVESTIGATE THIS EVENT. H6 (METHOD) CODE 38: CO'S EVAL OF THE X-RAY TAKEN OF TUBE PLACEMENT BY THE UF REVEALED THAT THE RIGHT MAINSTEM BRONCHUS DOES NOT APPEAR TO HAVE BEEN INTUBATED. THIS IS SUBSTANTIATED BY THE FINDING THAT BOTH LUNGS APPEAR TO BE EQUALLY VENTILATED. THE X-RAY ALSO REVEALED THAT THE PT APPEARED TO BE A SMALL ADULT OR A CHILD. H6. (CONCLUSION) CODE 62; CO HAS DETERMINED THAT PT SELECTION MAY BE A CONTRIBUTING FACTOR TO THIS EVENT.
A FILTER OPENING WAS INCOMPLETE AFTER DEPLOYMENT VIA THE FEMORAL APPROACH. ANOTHER FILTER WAS SUCCESSFULLY PLACED WITH NO PATIENT COMPLICATIONS. THIS FILTER REMAINS IMPLANTED AND WILL NOT BE AVAILABLE FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. FOLLOW UP INDICATED FREQUENT AND/OR CONTINUOUS FLUSHING WAS NOT PERFORMED PRIOR TO DEPLOYMENT AND MAY HAVE CONTRIBUTED TO THIS EVENT.
AN 85 YR OLD PT WAS FOUND PULSELESS AND WITHOUT RESPIRATORY MOVEMENT. ACLS WAS INITIATED. THE RHYTHM NOTED WAS VENTRICULAR FIBRILLATION. THE PHYSICIAN CHARGED THE UNIT TO 200 JOULES, AND THE PADDLES WITH CONDUCTION MEDIUM WERE PLACED ON THE PT'S CHEST. THE DISCHARGE BUTTONS WERE DEPRESSED SIMULTANEOULSLY AND THE SCREEN INDICATED THAT 200J WERE DELIVERED BUT THERE WAS NO MOVEMENT NOTED ON THE PT. THE DEFIBRILLATOR WAS THEN CHARGED TO 300J AND 360J WITH THE SAME RESULTS (NO PT MOVEMENT DURING DEFIBRILLATOR DISCHARGE). THE COMPLAINANT INDICATED THAT THERE WAS A "SMELL OF SKIN BURNING" AFTER EACH DISCHARGE. ANOTHER UNIT (MFR UNKNOWN) WAS OBTAINED WITH "PROPER RESULTS". THE PT EXPIRED AFTER 20 MINUTESD OF ACLS. THE COMPLAINANT HAS INDICATED THAT THE REPORTED MALFUNCTION DID NOT CONTRIBUTE TO THE PT OUTCOME.
THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE. THE SUTURE KNOT UNTIED WHICH RESULTED IN BLEEDING. THE HOSP HAS NOT SUPPLIED ANY ADD'L INFO.
11/12/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE ACCOUNT OBTAINED DISCREPANT RESULTS WHEN A SERUM SAMPLE WAS RUN ON THE DEVICE FOR A POSITIVE RESULT YET THE PT SAMPLE WAS REPEAT TESTED USING THE A QUANTITATIVE BETA HCG ENZYME IMMUNOASSAY FOR A RESULT=<1.3 MLU/ML. THE PHYSICIAN WAS AWARE OF THE DISCREPANCY AND NO TREATMENT WAS ADMINISTERED. THE PT WAS BEING SEEN FOR VAGINAL BLEEDING AND THE PT HAD TAKEN DEPO-PROVERA. 2/27/96 WAS THE DATE OF THE LAST DEPO-PROVERA DOSE. THE PT DID NOT FOLLOW-UP WITH THE PHYSICIAN SO THE CAUSE OF THE VAGINAL BLEEDING IS UNK.
EVALUATION COMPLETE-FINAL REPORT. THE INVESTIGATION CONCLUDED THAT PATIENT SAMPLE WAS NEUTRALIZED BY BOTH MOUSE AND GOAT LGG. PRODUCT LABELLING HIGHLIGHTS HAMA. ADDITIONAL INFORMATION INDICATES THE PATIENT HAD BEEN SCHEDULED FOR A DR. VISIT AND THE PATIENT DID NOT FOLLOW-UP. NO FURTHER PATIENT INFORMATION IS AVAILABLE.
IMPLANT PLACED 7/31/96 AND REMOVED 9/19/96. ONE PERSON AFFECTED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. THERE WAS TISSUE IN THE APICAL HOLES. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
DURING THE PROCEDURE THE FITTING ON THIS DEVICE WAS DEFECTIVE. THE CONNECTOR TO THE TUBING WAS CRACKED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
PT HAD PACEMAKER PLACED 7/96. 10/6/96 REPORTEDLY THE PT PASSED OUT IN THE BATHROOM AT HOME. BECAME CONSCIOUS AFTER 2-3 MINS AND WAS ADMITTED TO HOSP FOR PACEMAKER REPLACEMENT. NO ADD'L UNEXPECTED NEGATIVE RESULTS DURING HOSPITALIZATION. PACEMAKER GENERATOR NORMAL, BUT PACEMAKER LEAD REPLACED. DISCHARGED 10/10/96.
THE DEVICE WAS IMPLANTED ON 9/5/96 FOR INFUSION OF CHEMOTHERAPY. ON 11/4/96, THE FACILITY PURCHASING DEPT CONTACTED THE MFR AND REPORTED THAT ON 10/31/96, THE DEVICE "CAUSED PAIN IN THE PT'S SHOULDER WHEN FLUSHED AND NO BLOOD WAS BEING RETURNED." AS A RESULT, CHEMOTHERAPY COULD NOT BE GIVEN THROUGH THE DEVICE. THE DEVICE WAS EXPLANTED ON 10/31/96. UPON EXPLANT, IT WAS DISCOVERED THAT THERE WAS "A CRACK IN THE PORT."
THE EXPLANTED DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED WITH THE FOLLOWING RESULTS: THE UNIT WAS RECEIVED WITH THE DEVICE CATHETER NOT PROPERLY ASSEMBLED TO THE DEVICE. THE DEVICE SEPTA APPEARED ABNORMALLY FREE WITH NO EVIDENCE OF INTERNAL DAMAGE. THE 4-1/8"POLYURETHANE DEVICE CATHETER SHOWED A PIN HOLE 1/4" FROM THE BAYONET LOCK. EVIDENCE OF "PINCH-OFF" SYNDROME WAS SEEN APPROX ONE INCH FROM THE DISTAL END. THIS AREA APPEARED COMPRESSED AND LONGITUDINALLY SLIT. THE DAMAGED AREA OF CATHETER READILY LEAKED WHEN FLUSHING/PRESSURIZING. AFTER ISOLATING THE DAMAGED AREA OF CATHETER, THE DEVICE WAS LEAK TIGHT. THE DEVICE BODY APPEARED ABNORMALLY FREE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CATALOG/LOT NUMBER AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CATALOG/LOT NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. THE FACILITY'S REPORT THAT THERE  WAS "A CRACK IN THE PORT" COULD NOT BE CONFIRMED BY THE RESULTS OF THE MFR'S ANALYSIS; HOWEVER, THE MFR'S ANALYSIS DID REVEAL LONGITUDINAL SLITS IN THE DEVICE CATHETER WHICH READILY LEAK AND APPEAR TO BE ATTRIBUTABLE TO "PINCH-OFF" SYNDROME. THE FACILITY WILL BE ISSUED AN ARTICLE EXCLUSIVE TO "PINCH-OFF" SYNDROME DIAGNOSIS FOR THEIR REVIEW IN AN ATTEMPT TO PREVENT FUTURE RECURRENCE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE IN THIS EVENT.
THE DEVICE WAS USED DURING A LAP CHOLECYSTECTOMY PROCEDURE. THE INSTRUMENT LEAKED PNEUMOPERITONEUM. NO PT INJURY REPORTED.
11/12/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA. THE HOSP REPORTED A SPECIFIC PRODUCTION LOT. HOWEVER, UPON INSPECTION OF THE SUBJECT DEVICE, CO DETERMINED THAT THE LOT NUMBER WAS REPORTED TO CO INCORRECTLY. THEREFORE, CO HAS REPORTED THE LOT NUMBER AS UNKNOWN.
DURING A PTCA PROCEDURE THE BALLOON OF THIS DEVICE RUPTURED. NO FURTHER INFO IS AVAILABLE. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED OF CO'S ANALYSIS.
COMPLAINANT ALLEGED THAT STAFF MEMBERS WERE TREATING A PT (AGE AND GENDER UNK) WHOSE RHYTHM HAD MOVED TO V-TACH. THE STAFF ATTEMPTED TO DISCHARGE THE UNIT TWICE AT 200J USING MULTI-FUNCTION ELECTRODES. THE STAFF INDICATED THAT WHEN THE READY TONE SOUNDED, THE STAFF PRESSED THE DISCHARGE BUTTON, BUT THE UNIT WOULD NOT DISCHARGE. THE UNIT'S READY TONE CONTINUED TO SOUND AND THE 200J MESSAGE REMAINED ON THE MONITOR SCREEN. THE STAFF OBTAINED A SET OF PADDLES AND DEFIBRILLATED THE PT. THERE WAS NO ADVERSE EFFECT ON THE PT.
THE PRODUCT WAS USED DURING RECONSTRUCTIVE SURGERY. THE SUTURE ABSORBED QUICKLY AND LOST TENSILE STRENGTH. THE SURGEON REMOVED THE SUTURE AND COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT.
THE BALLOON OF THIS DEVICE FAILED TO INFLATE AT PREP. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
CULTURE RESULTS WERE REPORTED TO BE A STAPHYLOCOCCUS SPECIES (NOT SPECIFIED). PATIENT OUTCOME IS REPORTED TO BE FAVORABLE.
TE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE. THE SUTURE KNOT UNTIED WHICH RSULTED IN BLEEDING. THE SURGEON APPLIED ANOTHER SUTURE TO CORRECT THE CONDITION.
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP CLIPS DON'T CLOSE. THERE WAS NO CONSEQUENCE TO THE PT.
IMPLANT PLACED 3/28/96 AND REMOVED 9/20/96. ONE PERSON AFFECTED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANTS WERE EVALUATED AND FOUND TO MEET SPECIFICATIONS AND TO HAVE TISSUE IN THE APICAL HOLES. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANTS ARE NOT BELIEVED TO BE THE CAUSE OF FAILURE.
ON 10/28/96, THE MFR RECEIVED INFO FROM ITS DISTRIBUTOR THAT A FACILITY IN THEIR TERRITORY OPENED THE DEVICE TRAY AND DISCOVERED THE PORT TO BE MISSING. FURTHER COMMUNICATION WITH THE FACILITY UNIT MANAGER, ON 10/29/96, REVEALED THAT THE DEVICE WAS OPENED IN THE OR; HOWEVER, IT WAS NOT IN THE STERILE FIELD. AS A RESULT OF THIS EVENT, THE PT'S SURGERY WAS PROLONGED UNTIL ANOTHER DEVICE COULD BE OBTRAINED FROM FACILITY INVENTORY.
THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: THE ORIGINAL DEVICE PACKAGE CONTAINING SEVERAL ITEMS APPEARED TO HAVE BEEN OPENED. THE EDGES WERE STAPLED CLOSED. THE DEVICE WAS NOT INSIDE THE STAPLED PACKAGE. ALL ITEMS RECEIVED DID NOT APPEAR TO HAVE BEEN USED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG AND LOT NUMBER  AND HAS NOT IDENTIFIED ANY TRENDS. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE AND THE DEVICE ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.
DURING A NEPHROSTOMY TUBE PLACEMENT FOR A PT WITH COLON CANCER, THE DISTAL TIP OF THE .018 GUIDEWIRE DETACHED IN THE KIDNEY. THERE ARE NO PLANS TO REMOVE THE TIP AND THE PT SUFFERED NO SEQUELAE FROM THIS EVENT. THIS DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. CO'S FOLLOW UP REVEALED THAT THE WIRE HAD BEEN TWISTED AND  MANIPULATED AFTER RESISTANCE WAS ENCOUNTERED WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTION FOR USE STATE: "ADVANCEMENT AND/OR WITHDRAWAL OF .018/.038" WIRES SHOULD BE SMOOTH AND WITHOUT RESISTANCE. DO NOT USE EXCESSIVE FORCE. IF RESISTANCE IS FELT, CAREFULLY REMOVE WIRE AND SYSTEM AS A UNIT."
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. THE KNIFE BLADE DISENGAGED. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PT INJURY REPORTED.
DURING A PTCA PROCEDURE THE BALLOON OF THIS DEVICE RUPTURED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
ON 10/23/96, THE FACILITY OR NURSE CONTACTED A MFR NURSE AND REPORTED THAT UPON OPENING THE DEVICE PACKAGE, IT WAS NOTED THAT THE POLYURETHANE DEVICE CATHETER WAS "COILED AND STIFF" IN THE PACKAGE. A SECOND DEVICE WAS THEN OPENED AND THE SAME CHARACTERISTICS WERE NOTED. THE MFR NURSE THEN RECOMMENDED THAT THE DEVICE CATHETER BE SOAKED IN WARM SALINE IN AN ATTEMPT TO SOFTEN THE CATHETER. SEVERAL HOURS LATER ON 10/23/96, THE FACILITY OR NURSE CONTACTED THE MFR NURSE AND REPORTED THAT THE DEVICE CATHETER HAD BEEN SOAKED AS RECOMMENDED; HOWEVER, THIS DID NOT SEEM TO HELP. THE PHYSICIAN HAD IMPLANTED ONE OF THE DEVICE CATHETERS INTO THE PT, A BLOOD RETURN WAS OBTAINED AND THE DEVICE APPEARED TO BE FUNCTIONING; HOWEVER, X-RAYS REVEALED THAT THE DEVICE CATHETER WAS NOT LYING SMOOTHLY AND A BEND WAS NOTED WHICH IS NOT BELIEVED TO BE ANATOMICAL.
THE MANUFACTURER HAS COMPLETED ITS ANALYSIS OF THE RETURNED DEVICE AND THE RESULTS ARE AS FOLLOWS: A DEVICE WITH A PRE-ATTACHED 5 FRENCH POLYURETHANE CATHETER WAS OBTAINED FROM THE MANUFACTURER'S FINISHED GOODS TO USE A "CONTROL" FOR COMPARISON PURPOSES. VISUAL EXAMINATION OF BOTH DEVICE CATHETERS AND PALPATIONS OF THEIR ENTIRE LENGTHS REVEALED NO DIFFERENCES. MICROSCOPIC EXAMINATION OF THE SURFACE OF THE RETURNED DEVICE CATHETER AND THE CONTROL CATHETER REVEALED NO DIFFERENCES, DEFECTS OR ANOMALIES. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CATALOG/LOT NUMBER AND NO MANUFACTURING VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. IN ADDITION, A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CATALOG/LOT NUMBER AND NO TRENDS WERE IDENTIFIED OR OTHER  REPORTS OF THIS NATURE. THE FACILITY'S COMPLAINT THAT THE DEVICE CATHETER WAS "COILED AND STIFF" WAS NOT CONFIRMED BY THE RESULTS OF THE MANUFACTURER'S ANALYSIS. NO DEFECTS OR ANOMALIES WERE FOUND ON THE RETURNED DEVICE. THE MANUFACTURER HAS ATTEMPTED TO OBTAIN FOLLOW UP INFORMATION CONCERNING THE DEVICE THAT HAD BEEN IMPLANTED: HOWEVER, ATTEMPTS HAVE BEEN UNSUCCESSFUL TO DATE. THE FACILITY WILL BE NOTIFIED IN WRITING THAT SHOULD DIFFICULTIES BE EXPERIENCED IN THE FUTURE WITH THIS DEVICE, THEN THE MANUFACTURER WILL REOPEN ITS INVESTIGATION OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MANUFACTURER IS NOW CLOSING ITS FILE ON THIS EVENT.
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. JAWS WOULD NOT OPEN AFTER FIRING. THE SURGEON MANUALLY MANIPULATED THE DEVICE FREE. NO PT INJURY OCCURRED.
11/14/96-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.
THE DEVICE WAS USED DURING A COLON RESECTION PROCEDURE. THE INSTRUMENT WAS DIFFICULT TO REMOVE FROM TISSUE. THE SURGEON MANUALLY MANIPULATED THE DEVICE FREE. NO PT INJURY OCCURRED.
THE PERQUTANEOUS TRACHEOSTOMY. TRACH WAS PLACED AND DIFFICULTY WAS ALLEGEDLY ENCOUNTERED VENTILATING THE PT. USING A BRONCHOSCOPE, THE CLINICIAN REPORTEDLY SAW PT TISSUE AT OR NEAR THE TIP OF THE TUBE. THE CLINICIAN STATED THAT HE HAD OR MAY HAVE INTUBATED THE RIGHT MAINSTEM BRONCHUS. THERE WAS NO REPORTED PT INJURY AS A RESULT OF THIS EVENT.
THE SUBMISSION OF THIS OR ANY OTHER INFO TO THE FOOD AND DRUG ADMIN BY SIMS, INC. PURSUANT TO 21 CFR PART 803, AND THE PUBLIC RELEASE OF SUCH INFO, DOES NOT CONSTITUTE AN ADMISSION BY THE CO THAT A SIMS DEVICE HAS MALFUNCTIONED. NOR DOES IT ESTABLISH THE EXISTENCE OF ANY CAUSAL CONNECTION BETWEEN A SIMS DEVICE AND A REPORTED DEATH OR SERIOUS INJURY. NI ENTRY THROUGHOUT THE FORM-CO HAS CONTACTED THE USER FACILITY REQUESTING A SITE VISIT TO FURTHER DISCUSS AND INVESTIGATE THIS EVENT. H6: (METHOD) CODE 38: CO'S EVAL OF THE X-RAY TAKEN OF TUBE PLACEMENT BY THE USER FACILITY REVEALED THAT THE RIGHT MAINSTEM BRONCHUS DOES NOT APPEAR TO HAVE BEEN INTUBATED. THIS IS SUBSTANTIATED BY THE FINDING THAT BOTH LUNGS APPEAR TO BE EQUALLY VENTILATED. THE X-RAY ALSO REVEALED THAT THE PT APPEARED TO BE SMALL ADULT OR A CHILD. H6. (CONCLUSION) CODE 62: CO HAS DETERMINED THAT PT SELECTION MAY BE A CONTRIBUTING FACTOR TO THIS EVENT.
ARRIVED ON SCENE ON 9/30 TO FIND A MALE PT AGE 49 IN CARDIAC ARREST. CREW ATTACHED UNIT. UNIT WENT TO ANALYZE, THEN WENT DEAD. POWERED BACK ON AND UNIT PROMPTED "LOW BATTERY." CUSTOMER HAS TRIED OTHER BATTERIES (EVEN A BRAND NEW ONE) WITH THE SAME RESULTS. CPR WAS PERFORMED. ABOUT THREE MINITES LATER A PARAMEDIC ARRIVED AND TOOK OVER PT CARE. PT WAS PRONOUNCED AT HOSP.
AS OF 11/22/96, THIS DEVICE HAS NOT ARRIVED AT CO.
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
A BALLOON BURST AT TEN ATMOSPHERES DURING AN ILIAC ANGIOPLASTY. THE DILATION WAS SUCCESSFUL WITH THIS BALLOON AND THERE WERE NO PT COMPLICATIONS. CO'S FOLLOW UP REVEALED THAT THE ARTERIAL LESION WAS CALCIFIED WITH NOTICEABLE FIBROTIC TISSUE. THIS DEVICE HAS NOT BEEN RETURNED FOR EVAL. NO FAILURE ANALYSIS IS AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. THE LESION WAS CALCIFIED AND COMPOSED OF FIBROTIC TISSUE WHICH CO BELEIVES CONTRIBUTED TO HIS EVENT AND DOES NOT ATTIBUTE IT TO THE DEVICE. WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "DUE TO THE EXTREMELY THIN WALL THICKNESS OF THE BALLOON CATHETERS THESE CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS... IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY,"
THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL REVEALED THE CATHETER SHAFT KINKED. MICROSCOPIC EXAMINATION AND PRESSURE TESTING IDENTIFIED A PIN-HOLE LEAK ONE CENTIMETER FROM THE DISTAL TRANSITION ZONE. THE BALLOON SURFACE WAS SCRATCHED. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTANT WITH CONTACT WITH A SHARP, EXTERNAL SOURCE, SCRATCHES ON THE BALLOON SURFACE AND A KINKED CATHETER SHAFT. IT WAS INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT AND DO NOT ATTRIBUTE IT TO THE DEVICE.
ACCORDING TO THE SOURCE, THE IV PUMP WAS SET TO DELIVER FENTANYL 1.2CC 1 HR. AFTER 2 HOURS PUMP ALARMED AND THE ENTIRE 10CC HAD INFUSED. THE PUMP WAS DISCONNECTED FROM PT AND A NEW PUMP WAS USED.
THIS MDR IS BEING FILED IN ORDER TO COMPLY WITH 21 CFR PART 803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT THE DEVICE ACTUALLY MALFUNCTIONED OR CAUSED ANY INJURY. H6: 68 DEVICE PERFORMED TO SPECIFICATIONS. THE DELIVERY HISTORY WAS REVIEWED AND NO RECORD REFLECTING THE CUSTOMER STATED PROTOCOL COULD BE FOUND. THE COMPLAINT WAS NOT DUPLICATED, HOWEVER ANALYSIS WAS INCONCLUSIVE.
SURGEON IMPACTED INSERT INTO THE VITALOCK CUP AND FELT IT DID NOT FIT TIGHT ENOUGH. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT CAUSED BY THIS EVENT.
SUMMARY OF EVALUATION: FUNTIONAL TESTS WITH TWO ACCEPTABLE VITALOCK OUTER SHELLS SHOWS THE RETURNED INSERT SEATED AND LOCKED PROPERLY IN EACH SHELL WITH SOME TOGGLE PRESENT. THIS TOGGLE IS IN COMPLIANCE WITH THE TOLERANCE REQUIREMENTS FOR THIS PRODUCTS. THE RETURNED INSERT FUNCTIONS AS INTENDED BY DESIGN.
SQUAD WAS ON THE SCENE OF A CARDIAC ARREST. THEY WERE USING A SEMI-AUTOMATED DEFIBRILLATOR. MEDIC ATTEMPTED TO DEFIBRILLATE THE PT AT 360 JOULES. AFTER SHOCKING AT 200 JOULES AND 300 JOULES, A PROMPT CAME UP ON THE SCREEN "CANNOT DUMP" "-93". THE MONITOR WAS SHUT OFF AND TURNED BACK ON. THE SAME THING OCCURRED AT 360 JOULES.
THERE WAS WHITE PARTICULATE IN THE CASSETTE. THE REPORTER INDICATED THAT IT WAS LIKELY SHEARED OFF THE INSIDE OF THE BURETTE INJECTION PORT.
THE CUSTOMER INDICATED THAT SAMPLES WOULD BE RETURNED TO CO FOR EVAL. SAMPLES HAVE NOT YET BEEN REC'D. CO BELIEVES, BASED ON PREVIOUS COMPLAINTS, THAT THIS ISSUE IS RELATED TO PARTICULATE MATTER FROM THE MOLDING PROCESS. PRODUCTION HAS BEEN NOTIFIED AND HAS IMPLEMENTED PROCEDURES TO REDUCE PARTICULATE MATTER FROM THE MOLDING PROCESS. LOT HISTORY REVIEW WAS NOT AVAILABLE AS THE LOT NUMBER IS UNK TO THE CUSOTMER. CO WAS UNABLE TO CONFIRM THIS ISSUE WITHOUT BENEFIT OF RETURNED PRODUCT BUT WAS ABLE TO DETERMINE A PROBABLE CAUSE. BASED ON THIS INFO, CO BELIEVES THAT THIS ISSUE HAS BEEN ADDRESSED AND THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. AN ADD'L REPORT WILL BE PROVIDED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF CO'S EVAL.
THE INNER PACKAGE WAS NOT SEALED. THE DEVICE WAS STERILIZED AND IMPLANTED. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR SURGICAL DELAY.
EVAL SUMMARY: THE DEVICE PROTRUDING OUT OF THE INNER PACKAGE IS LIKELY THE RESULT OF THE DEVCIE BEING SUBJECTED TO EXCESSIVE MOVEMENT DURING SHIPMENT AND HANDLING. THIS EVENT IS DEEMED AN ISOLATED INCIDENT AND IS UNLIKELY TO OCCUR UNDER NORMAL CONDITIONS.
DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, THE SURGEON TRANSECTED THE ROUND LIGAMENT. THE EZ35W WAS FIRED AND 3 ROWS OF STAPLES WERE NOTED WITH EACH STAPLE LINE. THE SURGEON CUT BETWEEN THE STAPLE LINES. THE AREA WAS OBSERVED TO BE HEMOSTATIC. APPROXIMATELY 30 MINUTES LATER THE SURGEON OBSERVED BLEEDING ALONG THE STAPLE LINE OF THE LEFT OVARIAN LIGAMENT. A BOVIE WAS USED TO COAGULATE THE BLEEDING. THE DEVICE WAS FROM A TRAY, LOT #J42NII. REP. WILL BE RETURNING SIX RELOADS DUE TO NOT KNOWING WHICH FIRING THE BLEEDING OCCURRED WITH. THERE WAS NO CONSEQUENCE TO THE PATIENT.
PT'S PENILE PROSTHESIS WOULD NOT INFLATE REQUIRING A REPEAT SURGERY. "CHECK CYLINDER ONLY."
DEVICE DID NOT INFUSE WHEN PUMP WAS SET FOR LOW RATE INFUSION. THE REPORTER INDICATED THAT THIS HAD OCCURRED ON ONE OTHER OCCASION BUT DID NOT PROVIDE SPECIFIC DETAILS.
THE CUSTOMER INDICATED SAMPLES WOULD NOT BE RETURNED TO CO FOR EVAL. CO BELIEVES THAT THIS ISSUE IS RELATED TO PARTRICULATE MATTER IN THE DEVICE. THE PARTICULATE MATTER IS FROM THE MOLDING PROCESS. PRODUCT HAS BEEN NOTIFIED AND HAS IMPLEMENTED PROCEDURES TO REDUCE PARTICULATE MATTER. LOT HISTORY REVIEW WAS NOT AVAILABLE AS THE LOT NUMBER WAS UNK TO THE CUSTOMER. CO IS UNABLE TO CONFIRM THIS ISSUE OR CONFIRM THE PROBABLE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVAL. BASED ON THIS INFO, CO BELIEVES THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. AN ADD'L REPORT WILL BE PROVIDED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF CO'S EVAL.
THE INFUSION PUMP WAS INVOLVED IN AN OVERDELIVERY OF A HEPARIN SOLUTION. REPORTEDLY THE PUMP DISPLAYED A RATE OF 20 ML/HR WITH A VTBI (VOLUME TO BE INFUSED) OF 426 ML AT ONE POINT. APPROX 3 HRS LATER THE PUMP WAS DISPLAYING A VTBI OF 0 AND THE BAG WAS EMPTY. THE PT'S PTT LEVEL WAS ELEVATED INITIALLY AND RETURNED TO NORMAL WITHIN 6 HRS. NO ADD'L INTERVENTION WAS REQUIRED.
SECTION F COMPLETED BY MFR. EVAL SUMMARY: FLOW ACCURACY TESTING WAS PERFORMED AT 125 ML/HR AND 10 ML/HR. THE RESULTS WERE WITHIN SPEC.
DURING A DIAGNOSTIC PROCEDURE A COMPETITOR'S CATHETER WAS BECOMING LODGED INSIDE OF THE HEMOSTASIS VALVE OF THIS DEVICE. IT WAS NECESSARY TO REMOVE AND REPLACE THIS DEVICE. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.
ENDOSSEOUS DENTAL IMPLANT REMOVAL. TEN IMPLANTS WERE PLACED IN CLASS II BONE DURING ROUTINE PROCEDURES. THREE OF THE 10 IMPLANTS FAILED (LOST OSSEOINTEGRATION) AND WERE REMOVED (SITES #3,18,19).
A RADIOPAQUE MARKER DETACHED AT THE SKIN SURFACE UPON INTRODUCTION DURING A PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE MARKER WAS REMOVED WITHOUT INCIDENT AND A DILATOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NOT PT COMPLICATIONS. THIS DEVICE IS CURRENTLY BEING EVALUATED BY THE MFR. UPON COMPLETION OF THE ENGINEERING EVAL, A SUPPLEMENTAL MW FORM WILL BE FORWARDED UNDER THE ABOVE NOTED SEQUENCE NUMBER. THE PT'S ANATOMY AND/OR USER TECHNIQUE MAY HAVE BEEN CONTRIBUTING FACTORS TO THIS EVENT. UNITIL THE COMPLETION OF THE ENGINEERING EVALUATION, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
THIS DEVICE WAS RETURNED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVALUATION INDICATED THE RADIOPAQUE MARKER WAS MISSING FROM THE UNIT AND NOT RETURNED. THE EXTRUSION CONTAINED ID WHERE THE MARKER HAD BEEN CRIMPED INTO POSITION. THE UNIT APPEARED BENT AND MANGLED. ALL OTHER ASPECTS OF THE UNIT WERE WITHIN REQUIRED SPECIFICATIONS. WITHOUT BEING ABLE TO EXAMINE THE RADIOPAQUE MARKER, A THOROUGH EVALUATION COULD NOT BE PERFORMED. CO THEREFORE CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT. HOWEVER, THE CONDITION OF THIS DEVICE UPON RECEIPT, BENT AND MANGLED, MAY INDICATE EXCESSIVE MANIPULATION WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. H.6. #200 - OTHER/ENTIRE DEVICE WAS NOT RETURNED, THEREFORE UNABLE TO PERFORM COMPLETE EVALUATION.
CO RECEIVED A REPORT OF DEVICE FAILURE FROM A CUSTOMER. THE REPORT STATED: "CORE FAILURE." MORE INFO WAS REQUESTED AND CO WAS TOLD IT BROKE DURING THE PROCEDURE AFTER SOME MANIPULATION (IT WAS NOT CLEAR HOW LONG THE DEVICE WAS USED). THE DR WAS ABLE TO REMOVE BOTH PIECES OF THE WIRE WITUOUT INCIDENCE TO THE PT.
ON EXAMINATION IT WAS NOTICED THE DISTAL END OF THE MAIN COIL WAS LIMP. CLOSER EXAMINATION OF THE DISTAL END REVEALED THE COREWIRE HAD BROKEN APPROX 0.5 CM FROM THE DISTAL TIP. THE MAIN COIL IS SLIGHTLY STRETCHED TOGETHER WITH THE LAMINATING SHEATH. THE LAMINATING SHEATH KEPT THE MAIN COIL TOGETHER, PREVENTING IT FROM BREAKING. FROM INFO RECEIVED IN THE COMPLAINT REPORT, IT WOULD APPEAR THE DEVICE BROKE DUE TO PROCEDURAL FACTORS WHICH EXTENDED THE PERFORMANCE OF THE DEVICE BEYOND ITS DESIGN LIMITS. THE MOST PROBABLE CAUSE FOR THE BREAK WOULD BE RELATED TO PROCEDURAL FACTORS WHICH EXTENDED THE PERFORMANCE OF THE DEVICE BEYOND ITS DESIGN LIMITS. FREQUENCY AND SEVERITY OF OCCURRENCE OF THIS EVENT ARE NOT ADDRESSED IN THE DEVICE LABELING. THE REPORTED EVENT IS NOT OCCURRING WITH GREATGER THAN EXPECTED FREQUENCY. THE REPORTED EVENT IS NOT OCCURRING WITH GREATER THAN EXPECTED SEVERITY. THIS INFO IS BASED ON INFO SUPPLIED TO CO WITHOUT INDEPENDENT VERIFICATION AS TO ITS ACCURACY, COMPLETENESS, OR CAUSAL RELATIONSHOP TO THE PRODUCT.
IMPLANT PLACED 6/7/96 AND REMOVED 9/26/96. ONE PERSON AFFECTED.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. THE PROBABLE CAUSE OF FAILURE IS THE PT'S SMOKING.
ICD LEAD FRACTURE REQUIRED HOSPITALIZATION FOR REPLACEMENT.
A PT RECEIVED AN INJURY WHEN A NURSE LAID A C1000T ON ITS SIDE DURING TRANSPORT CAUSING LIQUID OXYGEN TO LEAK. THE HOSP REPORTED VIA TELEPHONE THAT "THE INJURY WAS SUPERFICIAL AND ONLY REQUIRED ICE." THE OFFICIAL DIAGNOSIS IS UNAVAILABLE. PRODUCT LABELING WARNS OF THE HAZARDS OF NOT KEEPING THE UNIT IN AN UPRIGHT POSITION (ENCLOSED). THE HOSP ACKNOWLEDGED THAT THE INJURY RESULTES FROM USER-ERROR.
THIS REPORT IS BEING SUBMITTED AS A 30 DAY MDR. THE INFORMATION WAS PREVIOUSLY REPORTED ON A 10 DAY DISTRIBUTOR REPORT WITH THE REFERENCED DISTRIBUTOR NUMBER. THE DEVICE WAS RECEIVED BY CO ON 11/15/96 AND WILL BE SHIPPED TO FOREIGN MFR ON 11/18/96.
DURING A CATARACT EXTRACTION PROCEDURE, PARTICULATE CAME FROM THIS HANDPIECE AND ENTERED THE PT'S EYE. ALL PARTICULATE WAS ABLE TO BE ASPIRATED.
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. A FILTER TEST WAS PERFORMED ON THIS HANDPIECE. NO PARTICLES WERE FOUND.
CATHETER DEFLATED BY ITSELF. BALLOON TESTED. AIR LEAK AT VALVE. PT HAD TO GO TO RADIOLOGY FOR CYSTOGRAM AND THEN RETURNED TO OR FOR REINSERTION OF NEW FOLEY.
4 IMPLANTS PLACED 9/30/96. AT ROUTINE CHECK ON 10/23/96, PT WAS EXPERIENCING PAIN AT ONE SITE. INTEGRATION HAD NOT OCCURRED YET, SO IT WAS REMOVED. PT IS A NON-SMOKER/NO MED/ODENTULOUS.
A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED AND NO DEVIATIONS WERE FOUND. THE RETURNED IMPLANT WAS EVALUATED AND IT WAS FOUND TO MEET SPECIFICATIONS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
A PT WHO PREVIOUSLY HAD A FILTER PLACED AT ANOTHER INSTITUTION WAS EXPERIENCING BACK PAIN. THE X-RAY REVEALED THE FILTER HAD PERFORATED THE INFERIOR VENA CAVA WITH ONE LEG OUTSIDE THE IVC POSTERIOR TO THE AORTA. IT WAS CONFIRMED THAT NO HEMATOMA OR AORTIC PERFORATION OCCURRED. FURTHER FOLLOW UP REVEALED THAT NO INVTERVENTION HAS BEEN PLANNED TO DATE. THE PT'S CONDITION IS STABLE AND PT HAS BEEN DISCHARGED AND SENT HOME. THIS DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVAL. NO FAILURE ANALYSIS WILL BE AVAILABLE. CO'S ATTEMPTS TO GAIN FURTHER INFORMATION HAS BEEN UNSUCCESSFUL.
THE BLOOD BACKED UP IN THE IV TUBING TO THE BURETTE WHILE THE PUMP WAS INFUSING. THE REPORTER INDICATED THAT THIS HAD OCCURRED ON TWO OTHER OCCASIONS BUT DID NOT PROVIDE SPECIFIC DETAILS.
THE CUSTOMER INDICATED SAMPLES WOULD NOT BE RETURNED TO CO FOR EVAL. LOT HISTORY REVIEW WAS NOT AVAILABLE AS THE LOT NUMBER WAS UNK TO THE CUSTOMER. CO IS UNABLE TO CONFIRM THIS ISSUE OR TO DETERMINE THE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVAL. CO IS CONTINUING TO INVESTIGATE THIS ISSUE. AN ADDITIONAL REPORT WILL BE PROVIDED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF CO'S EVAL.
THE GRAFT, WHICH WAS IMPLANTED FOR AN AORTIC ANEURYSM, LEAKED APPROX. 400CC OF BLOOD THROUGH ITS WALLS WHEN THE CLAMP WAS RELEASED. A TRANSFUSION SET WAS USED, SO THE BLOOD WAS RETURNED TO THE PT. THE MD REPEATEDLY CLOSED AND OPENED THE CLAMP UNTIL HEMOSTASIS WAS ATTAINED. AT THIS TIME, THE PT IS STILL IN SURGERY. THE PT'S CONDITION IS REPORTED AS FINE AT THIS TIME.
AN UNIMPLANTED SEGMENT OF THE COMPLAINT GRAFT WAS EVALUATED BY CO'S CONSULTING PATHOLOGIST. RECEIVED IN FIXATIVE IS A SEGMENT OF UNIMPLANTED VASCULAR GRAFT. THE SPECIMENT MEASURES 3.2 CM IN LENGTH BY 2.4 CM IN DIAMETER. THE SURFACES ARE CLEAN. REPRESENTATIVE SECTIONS ARE EMBEDDED. A COLLAGEN-COATED VASCULAR GRAFT IS IDENTIFIED. COLLAGEN IS PRESENT ON THE LUMINAL SURFACE, ADVENTITIAL SURFACE AND WITHIN THE INTERSTICES OF THE VASCULAR GRAFT. NO LOSS OF INTEGRITY OF THE COLLAGEN COATING IS IDENTIFIED. NO LOSS OF INTEGRITY OF THE VASCULAR GRAFT IS IDENTIFIED. AN INTACT COLLAGEN-COATED VASCULAR GRAFT IS IDENTIFIED WITH NO LOSS OF INTEGRITY OF THE COLLAGEN COATING.
IMPLANT PLACED 1/12/96 AND REMOVED 9/13/96. ONE PERSON AFFECTED.
THE INSERT DID NOT FIT IN THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
THE TIBIAL BASEPLATE AND TIBIAL INSERTS WERE VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. A DIMENSIONAL INSPECTION OF THE BASEPLATE FOUND THAT ALL SPECIFICATIONS RELATING TO INSERT MATING MET DESIGN REQUIREMENTS. THE TWO MEDIUM INSERTS WERE ASSEMBLED IN THE AS-RECEIVED CONDITION TO THE RETURNED BASEPLATE USING TWO THUMBS PRESSURE. RESULTS FOR BOTH INSERTS WERE A CRISP SNAP ACTION WITH FULL SEATING BUT LAXITY DETECTED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL THESE LOTS OF INSERTS FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR.
DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON AN UNK DATE THE OUTER GASKET ON THE 512 H RIPPED. A SECOND 512H WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
A1,2,3,4; B3,6,7; D10: INFO UNAVAILABLE: INFO UNAVAILABLE: SEE CORRESPONDENCE LOG: 10/30/96 11/48 SURGEON IS OUT OF THE OFFICE UNTIL 11/18/96. WILL SEND NNCL. 10/30/96 NNCL SENT. BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT'S OUTER GASKET "RIPPED" DURING SURGERY, MAKING THE INSTRUMENT NON-CONFORMING. THE TORN PIECE WAS REC'D TAPED TO THE HOUSING BOTTOM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE THE PRODUCTS. THE ASSEMBLY LOCATION HAS BEEN INFORMED OF THIS INCIDENT.
SINCE NO PRODUCT IS TO BE RETURNED FOR EVAL AND THE ACTUAL AMOUNT OF BLOOD LOST THROUGH THE GRAFT IS NOT ATTAINABLE, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. NOTE: ITEMS MARKED "NI" ARE NOT AVAILABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE 86: THE MANUFACTURING BATCH RECORDES FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL- NO SIMILAR COMPLAINTS AGAINST THIS BATCH. ADD'L NOTE: ALTHOUGH THERE ARE NO SIMILAR COMPLAINTS AGAINST THIS BATCH, THE MFR HAS IMPLEMENTED A VOLUNTARY RECALL BASED UPON A REASSESSMENT OF THE POROSITY DATA FOR THIS BATCH.
THE GRAFT "OOZED" BLOOD THROUGH ITS WALLS WHEN THE CLAMP WAS RELEASED. THE MD THEN PACKED THE GRAFT WITH SPONGES, PTFE PLEDGETS SUTURED ON AND THE HEPARIN WAS REVERSED WITH PROTAMINE TO STOP THE BLEEDING. THE BLEEDING STOPPED AND THE GRAFT WAS LEFT IN. DURING THE PROCEDURE, A TRANFUSION SET WAS USED AND ONE UNIT WAS RETURNED TO THE PT. IN ADDITION, 1000CC OF HESPAN (VOLUME EXPANDER) WAS GIVEN. THE PT'S CONDITION WAS OK AND THE PT WAS SUBSEQUENTLY DISCHARGED. NOTE: THE NURSE STATES THAT THE OVERALL BLOOD LOSS DURING THE PROCEDURE WAS APPROX. 750CC, BUT THE ACTUAL AMOUNT LOST THROUGH THE GRAFT WALLS WAS UNKNOWN AND COULD NOT BE DETERMINED.
IMPLANT PLACED 11/30/95 AND REMOVED 9/27/96. ONE PERSON AFFECTED.
AS THE LOT NUMBER WAS UNK, A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED. THE RETURNED IMPLANT WAS EVALUATED AND FOUND TO BE CLEAN AND TO MEET SPECIFICATIONS. CLINICAL STUDIES AND PUBLISHED LITERATURE INDICATE THAT A 3-5% FAILURE RATE MAY BE ENCOUNTERED, EVEN WITH THE BEST CARE. THE IMPLANT IS NOT BELIEVED TO BE THE CAUSE OF FAILURE.
A BALLOON BURST AT AN UNKOWN PRESSURE DURING THE SECOND INFLATION OF CALCIFIED LESION VIA AN IPSILATERAL APPROACH. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PT COMPLICATIONS. THIS PRODUCT HAS BEEN DESTROYED BY THE USER FACILITY. NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZTION OR USE IN A CALCIFIED LESION. THIS DEVICE WAS USED IN A CALCIFIED LESION WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT OT THE DEVICE. WITHOUT EVALUATING THE PRODUCT  CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.
THE TIBIAL BASEPLATE AND TIBIAL INSERTS WERE VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. A DIMENSIONAL INSPECTION OF THE BASEPLATE FOUND THAT ALL DIMENSIONS RELATING TO INSERT MATING MET DESIGN REQUIREMENTS. THE TWO MEDIUM INSERTS WERE ASSEMBLED IN THE AS-RECEIVED CONDITION TO THE RETURNED BASEPLATE USING TWO THUMBS PRESSURE. RESULTS FOR BOTH INSERTS WERE A CRISP SNAP ACTION WITH FULL SEATING BUT LAXILY DETECTED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL THESE LOTS OF INSERTS FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR.
IT WAS REPORTED THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. IT WAS REPORTED BY THE REP STAPLE MALFORMED AND REANASTOMOSED BY ANOTHER INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RELOADED AND FIRED. IT FIRED AND FORMED STAPLES AS DESIGNED. THE REPORTED INCIDENT OF MALFORMED STAPLES COULD NOT BE RECREATED. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINOUSLY IMPROVE CO'S PRODUCTS.
THE TIBIAL BASEPLATE AND TIBIAL INSERTS WERE VISUALLY AND DIMENSIONALLY INSPECTED AS RECEIVED. A DIMENSIONAL INSPECTION OF THE BASEPLATE FOUND THAT ALL DIMENSIONS RELATING TO INSERT MATING MET DESIGN REQUIREMENTS. THE TWO MEDIUM INSERTS WERE ASSEMBLED IN THE AS-RECEIVED CONDITION TO THE RETURNED BASEPLATE USING TWO THUMBS PRESSURE. RESULTS FOR BOTH INSERTS WERE A CRISP SNAP ACTION WITH FULL SEATING BUT LAXILY DETECTED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL OF THESE LOTS OF INSERTS FOUND THAT NO DISCREPANCIES WERE REPORTED DURING MFR.
REASON FOR EXPLANT STATED AS "INFECTION, AORTIC ROOT ANEURYSM" ON EXPLANT FORM.
PT STOOD UP AND FOLEY FELL OUT OF BLADDER. NEW FOLEY WAS INSERTED IN PT'S ROOM. PT DID NOT GO BACK TO SURGERY. CATHETER NOT KEPT FOR INSPECTION/EVALUATION.
PT BECAME PREGNANT AND WAS TAKEN OFF COUMADIN AND PLACED ON HEPARIN. LEAFLET WAS IMPEDED DUE TO THROMBUS AT EXPLANT. VALVE WAS IMPLANTED.
PHALANGE AT THE END OF PEG DISCONNECTED; DISCOVERED WHEN TUBE REMOVED.
RETRACTABLE HOOK WAS DIFFICULT TO HANDLE.