Description of Event or Problem · 1
BARD 3000 BEING USED DURING CASE FOR CAUTERY PURPOSE. PATIENT WAS PROPERLY GROUNDED. BARD SETTING @30 CUTTING AND 30 COAGULATION. CUTTING NOT WORKING @ SETTING SO INCREASED AT DOCTORS REQUEST WITH NO RESULT. BARD MODES CHANGED PER DOCTOR REQUEST. WHILE USING BARD AFTER SEVERAL ATTEMPTS AND CHANGES DOCTOR FELT THERE WAS AN ELECTRICAL SURGE. BARD 3000 REPLACED WITH BIRTCHER 4400. MINOR PATINET INJURY-PARTIAL TRANSECTION OF RIGHT GREATER CERVICLE NERVE DUE TO SURGE, AS STATED BY DOCTOR INVOLVED IN CASE.DEVICE 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-NOV-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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: TELEMETRY FAILURE, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE, INVALID DATA. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.