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Patient 1
OM 01-10-92 PATIENT HAD AN ELECTIVE COLONOSCOPY WITHOUT APPARENT INJURY OR INCIDENT. PATIENT WAS RECOVERED AND DISCHARGED HOME. RETURNED ON 1/11/92 WITH ABDOMINAL PAIN, TAKEN TO SURGERY, EXPLORATORY LAP, POST-OP DX PERFORATED BOWEL. A VALLEY LAB CAUTERY UNIT WAS USED FOR THE COLONOSCOPY UNIT #00680, THE SETTING WERE COAG=2; CUTTING=0, A NON DISPOSABLE HOT BIOPSY FORCEPS WAS USED. THE CAUTERY UNIT WAS CHECKED BY BIO-MED AFTER THE SECOND INCIDENT ON 1/10/92. THE UNIT WAS FOUND TO MEET THE MANUFACTURER'S SPECIFICATIONSDEVICE 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-JUL-91. 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, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, INHERENT RISK OF PROCEDURE, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. 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 NOT DESTROYED/DISPOSED OF.