Description of Event or Problem · 1
ON MAY 12, 1993, A 53 YEAR OLD FEMALE WAS SCHEDULED FOR A LAPAROSCOPIC CHOLECYSTECTOMY. UPON INSERTION INTO THE ABDOMEN OF THE 10/11MM ENDOPATH TROCAR, A PART OF THE PROTECTIVE PORTION COVERING THE TIP BROKE OFF AND FELL INTO THE ABDOMINL CAVITY. SUCCESSFULLY CONCLUDED WITHOUT FURTHER INCIDENT. THE MANUFACTURER WAS NOTIFIED AND THE INSTRUMENT RETURNED TO THEM FOR THEIR FOLLOW-UP INVESTIGATION.ON AUGUST 17, 1993, DURING INSERTION OF A 10/11MM ENDOPATH TROCAR, A PART OF THE PROTECTIVE SHIELD BROKE OFF. THE SURGEON FELT IT WAS LODGED IN THE ABDOMINAL WALL. HOWEVER, HE WAS UNABLE TO LOCATE AND RETRIEVE IT, ELECTING TO LEAVE THE SMALL PORTION OF PLASTIC IN PLACE. THOUGH THE LAPARASCOPIC CHOLECYSTECTOMY WAS SUCCESSFULLY COMPLETED, THE FINAL OUTCOME IS YET TO BE DETERMINED. PLEASE NOTE THAT DIFFERENT SURGEONS WERE INVOLVED IN EACH CASEINVALID 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.