Description of Event or Problem · 1
ON MAY 15, 1992, A PATIENT UNDERWENT A COLECTOMY. A PROXIMATE LINEAR CUTTER WAS USED INITIALLY WITHOUT INCIDENT. A RELOADER UNIT WAS THEN USED. THIS UNIT DID NOT EXPEL ALL THE STAPLES. APPROXIMATELY 50% OF THE STAPLES WERE EXPELLED. THIS WAS DISCOVERED IMMEDIATELY. THERE WAS SOME FECAL CONTAMINATION OF THE SURGICAL FIELD AS A RESULT OF THIS EQUIPMENT MALFUNCTION. THIS WAS IMMEDIATELY CONTAINED AND THE PELVIS WAS IRRIGATED. THE BOWEL WAS CLOSED WITHOUT FURTHER INCIDENT.THE PATIENT HAD NO COMPLICATIONS FROM THIS INCIDENT.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.