Description of Event or Problem · 1
UPON COMPLETION OF EXPLORATORY LAPAROTOMY, THE E.S.U. DISPERSEMENT PAD WAS REMOVED FROM LEFT, UPPER THIGH OF THE PATIENT. 2 CM. X 1.1 CM. AREA NOTED TO APPEAR BLISTERED AND REDDENED WITH A LAYER OF SKIN ATTACHED TO UNDERSIDE OF DISPERSAL PAD (DURING PROCEDURE, E.S.U. SETTINGS WERE "50" CUTTING AND "25" COAG). NO EVIDENCE OF SOLUTIONS (PREP) NOTED TO BE IN AREA OF INJURY. SILVADENE DSQ. APPLIED TO PATIENT'S THIGH. PATIENT REPOSITIONED FOR HIP PROCEDURE AND NEW DISPERSAL PAD APPLIED ALONG WITH ANOTHER E.S.U. UNIT.OTHER DEVICES BEING USED DURING PROCEDURE:1 DRAGER ANESTHESIA MACHINE1 END TIDAL C02 MONITOR-OHMEDA1 PULSE OXIMETER-NELLCOR1 BLOOD PRESSURE MONITOR-CRITIKON1 PHYSIO CONTROL ECG MONITOR1 SONY MONITOR1 CAMERA CONSOLE-KARL STORZ1 VCR-PANASONIC1 LIGHT SOURCE-KARL STORZ1 VIEDO PRINTER-SONY1 LAPAROFLATOR-KARL STORZDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-OCT-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: A DEVICE FROM SAME LOT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, INCORRECT TECHNIQUE/PROCEDURE, UNANTICIPATED. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.