ELECTRODE, BIPOLAR, POINTED

Description of Event or Problem

THE EVENT OCCURRED IN CANADA. ACCORDING TO THE INFORMATION RECEIVED, THE WIRE OF CUTTING LOOP OVERHEATS AND VAPORIZED PROTECTIVE PLASTIC SHEATH, BURNT, ONE SIDE OF WIRE DETACHED FROM PLASTIC SHEATH, TROUBLE SHOOT: STOPPED USING AND SWITCHED TO MYOSURE XL, NO DELAY AND NO HARM ON PATIENT.

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).