VALLEY LAB

Description of Event or Problem

DURING CYSTOSCOPIC PROCEDURE, SURGEON REPORTED THE COAGULATION ON BOVIE WAS NOT WORKING (NO POWER) AND HE REQUESTED THAT THE POWER BE INCREASED. POWER WAS INCREASED TO 3-4 ON DIAL WITH NO IMPROVEMENT. DIAL INCREASED TO 5 AND SURGEON FINISHED PROCEDURE. HE REPORTED HE SAW A SPARK FLASH WHICH WAS RESULTED IN A PERFORATION OF THE BLADDER. BOVIE UNIT WAS REPLACED WITH DIFFERENT MACHINEDEVICE 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-DEC-92. 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: TELEMETRY FAILURE, OTHER. CONCLUSION: DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT, DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.