REPROCESSED ELECTROSURGICAL ELECTRODE

Description of Event or Problem

THE PROCEDURE WAS TO REMOVE AND REPLACE ANGLED MANDIBULAR PLATE. SURGICAL APPROACH FOR THIS PROCEDURE WAS INTRA-ORAL WITH THE INCISION AND CAUTERY ACTIVITY AT THE BASE OF THE GUM LINE WHERE IT MEETS THE MANDIBULAR INTRAORAL MUCOSA. ACCORDING TO THE CIRCULATOR'S ACCOUNT, THE DOCTOR'S WRIST WAS LAYING ON THE PT'S LOWER JAW TO STEADY THE CAUTERY DEVICE INTRAOP, SO THE TIP WAS ON THE INTRAORAL EXPOSED TISSUE, BUT THE SHAFT OF THE CAUTERY TIP WAS UP AGAINST THE LOWER LIP. AFTER DISSECTING DOWN TO THE IMPLANT, THE DOCTOR NOTICED CAUTERY MARKS (BURNS) ALONG THE LOWER LIP THAT WAS 'PROTECTED' BY THE INSULATION ON THE ELECTRODE. THE BURNS LOOKED LIKE '4 PIN HOLES/SPOTS'. IT WAS NOTICEABLE ENOUGH THAT THE DOCTOR CHOSE TO RESECT THE 'BURNT TISSUE' AND THE PT ENDED UP WITH 2-3 SUTURES FROM THAT RESECTION. IT WAS NOT RECALLED IF THE TISSUE WAS SENT TO PATHOLOGY FOR ANALYSIS. IT WAS NOTED IN THE POST CASE AUDIT, THERE WERE THREE VARIANCES LISTED IN THE PROCEDURE, WITH THIS CO TIP BEING ONE OF THEM.

Additional Manufacturer Narrative

THE DOCUMENTED COMPLAINT ABOUT THE (B)(6) STATED "INSULATION FAILED AND BURNED THE PT'S LIP DURING PLASTIC SURGERY." THE DEVICE USED IN THE PROCEDURE WAS NOT RETURNED FOR INVESTIGATION. DEVICES FROM THE SAME LOT OF THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WERE EVALUATED. (B)(4) PERFORMED THE VISUAL INSPECTION AND FUNCTIONAL TESTING OBSERVATIONS. THE DEVICE PASSED BOTH SETS OF OBSERVATIONS. THE DEVICE WAS TESTED ELECTRICALLY FOR CONTINUITY; THE INSULATION SHOWED NO VISUAL DAMAGE TO VERIFY THE COMPLAINT. THE COMPLAINT WAS UNABLE TO BE DUPLICATED OR CONFIRMED.