ELECTROSURGICAL UNIT

Description of Event or Problem

PATIENT RETURNED TO THE EMERGENCY ROOM ONE WEEK AFTER LEFT FEMORAL HERNIA REPAIR. PATIENT PRESENTED A RECTANGULAR LESION ON UPPER RIGHT THIGH DIMENSIONS APPROXIMATELY 47MM X 20MM. HOSPITAL INVESTIGATING POSSIBLE INVOLVEMENT OF ELECTROSURGICAL UNIT DISPERSIVE ELECTRODE PAD.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-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. RESULTS OF EVALUATION: UNANTICIPATED ADVERSE REACTION - SHORT TERM. 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 RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.