Description of Event or Problem · 1
THE SURGEON CLOSED THE BIPOLAR FORCEPS AND A SPARK RESULTED ALTHOUGH HE DID NOT HAVE THE FOOT SWITCH DEPRESSED. I SUSPECT THAT THE BIPOLAR WAS PLUGGED INTO THE MONOPOLARSIDE. SINCE THERE WERE TWO PLUGS, ONE WAS PROBABLY PLUGGED INTO THE ACTIVE TERMINAL AND THE OTHER PLUG PUT INTO THE JACK THAT SWITCHES THE CUT MODE ACTIVE. SINCE THE BIPOLAR FORCEPS ARE NOW ACTING AS A SWITCH WHEN THEY ARE CLOSED, THEY ACTIVATED THE ESU IN THE CUT MODE. CURRENT FLOWED FROM THE CLOSED TIP OF THE FORCEPS TO THE REM PAD ON THE PATIENT. THERE ARE NO SAFEGUARDS ON THIS INSTRUMENT TO PREVENT THIS FROM HAPPENINGDEVICE 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-MAY-91. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. 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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.