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Patient 1
PATIENT ADMITTED TO G.I. LAB FOR COLONOSCOPIC EXAM DUE TO CHANGE IN BOWEL HABITS. THIS PROCEDURE WENT AS PLANNED WITHOUT COMPLICATION. PATIENT WAS RE-ADMITTED THE NEXT DAY WITH SEVERE ABDOMINAL PAIN. IT WAS DETERMINED THAT THERE WERE TWO LEFT COLON BURNS. PATIENT WAS PLACED ON ANTIBOTICS & OBSERVED & RECOVERED. EQUIPMENT AND OTHER SIMILAR INDICATORS WERE NOT ACCURATE, THUS, CAUSING THIS BURN;UNKNOWN TO PHYSCIAN WHO ASSUMED INDICATORS TO BE ACCURATE. THIS HAS BEEN ADDRESS BY BIO-MEDDEVICE 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-SEP-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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: DESIGN, TELEMETRY FAILURE, NONE OR UNKNOWN, POWER SUPPLY. CONCLUSION: DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.