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Patient 1
64 YEAR OLD FEMALE, IN SATISFACTORY CONDITION, WAS UNDERGOING SURGERY FOR REMOVAL OF A LIVER TUMOR. AFTER THE SURGERY WAS IN PROGRESS, THE PRIMARY SURGEON REQUESTED A SECOND BOVIE UNIT BE SET UP FOR THE SURGEON ASSISTING HIM. THE RN PLACED THE SECOND BOVIE UNDER THE PATIENT'S RIGHT THIGH. THE PATIENT WAS ALREADY DRAPPED AND VISABILITY WAS POOR. THE NURSE WAS WEARING GLOVES, PER UNIVERAL PRECAUTIONS AAND DID NOT FEEL THE TED STOCKING ON THE PATIENT'S LEG. THE BOVIE PAD WAS PARTIALLY PLACED OVER THE TOP OF THE STOCKING. AT THE END OF THE SURGICAL PROCEDURE A 10 CM BURN WAS FOUND ON THE RIGHT THIGH. THE AREA WAS EXCCISED AND SUTURED CLOSED BY THE SURGEONDEVICE 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-MAR-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. RESULTS OF EVALUATION: DESIGN - INADEQUATE, MISAPPLICATION OF DEVICE. CONCLUSION: USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.