Description of Event or Problem · 1
LEFT BUCCAL MUCOSA SUPERFICIAL BURN DISCOVERED FOLLOWING REMOVAL OF TONSILS. DISPOSABLE ENDOTRACHEAL TUBE AND NON-DISPOSABLE MOUTH GAG IN PLACE. ANOTHER CO'S ELECTROSURGICAL UNIT AND REM GROUNDING PAD USED. SAME CO'S DISPOSABLE SUCTION COAGULATION AND NEEDLE ELECTRODE USE. THIS CO'S DISPOSABLE SWITCHPEN AND OLSEN BOVIE EXTENSION USED. BIOMED CHECKED ELECTROSURGICAL UNIT AND GROUNDING PAD AND FOUND NO MALFUNCTION. THIS CO WILL MAKE AN ON SITE VISIT TO TEST THE SWITCHPEN.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. 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, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.