RESECTOSCOPE SHEATH, 26 FR., SET

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).

Description of Event or Problem

THE EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE LOOP GLOWS BRIGHT ORANGE AND EVENTUALLY BURNS OUT (WIRE BREAKS) AND THE CURRENT ARCS TO THE TELESCOPE AND DAMAGES THE DISTAL LENS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.