EXTENDED BLADE ELECTRODE

Description of Event or Problem

THE EXTENDED BLADE ELECTRODE WAS BEING UTILIZED DURING CARDIAC SURGERY. FOR NO APPARENT REASON THE ELECTRODE ARCED. THE SPARK STRIKING A (BLOOD) SATURATED OPERATIVE SPONGE. THERE WAS NO INJURY TO THE PATIENT OR USER(S). INVESTIGATION BY IN-HOUSE BIO-TECH FOUND ALL EQUIPMENT IN GOOD WORKING ORDER (I.E. THE "BOOGIE" INTO WHICH THE BLADE FITS AND ELECTRICAL CURRENT IS DRAWN). ONE TIME INCIDENT NO OTHER SIMILAR EVENTS REPORTED. EQUIPMENT RETURNEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT 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. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED, NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.