Description of Event or Problem · 1
DURING A TONSILECTOMY, THE WECK NEEDLE ELECTRODE WAS USED WITH THE COMMED TECH-SWITCH PENCIL AND A VALLEY LAB MODEL SSE2, SERIAL NUMBER E313760JV SOLID STATE ELECTROSURGERY UNIT. THE CHILD WAS ACCIDENTALLY BURNED IN THE CORNER OF THE MOUTH AND LIP. VISUAL EVALUATION OF THE NEEDLE ELECTRODE SHOWS EVIDENCE OF CHAR AND PLASTIC MELT AT THE PENCIL JUCTION POINT. AT THE SETTINGS USED A SIMILAR NEEDLE ELECTRODE AND PENCIL SWITCH PRODUCED NO LEAKAGE OR ARCING TO A SALINE SOAKED PAD WITH THE ELECTRODE TOTALLY AND FIRMLY INSERTED. INSERTIONS TO THE FIRST POINT OF RESISTANCE RESULTED IN SEVERE ARCING AND PLASTIC MELT. THERE ARE NO MARKINGS OR SURE INDICATORS OF PROPER ELECTRODE INSERTION. PLASTIC SURGERY CONSULT RECOMMENDEDDEVICE NOT 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, A DEVICE FROM SAME LOT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS, INSULATION DEGRADATION/DETERIORATION, LABELING - INCOMPLETE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.