CUTTING LOOP, BIPOLAR, F/USE W/26053EB

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS ADDED IN SECTION D10. - 26053EB, WORKING ELEMENT (LOT: ZM02). - 26053CB, INNER SHEATH F. RESECT. SHEATH, 15 FR. (LOT: YL13). - UH801, BIPOLAR HIGH FREQUENCY CORD, 400 CM (LOT: TM02). - 26053SC, RESECTOSCOPE SHEATH, 15 FR. (LOT: TL03). THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "DURING A HYSTEROSCOPIC MYOMECTOMY, A CLEAR ELECTRICAL SPARK WAS OBSERVED AT THE LOOP, WITH EXCESSIVE HEAT GENERATION. THE HANDPIECE BECAME NOTICEABLY HOT AND BURNT TISSUE FRAGMENTS WERE SEEN WITHIN THE UTERINE CAVITY. ON INSPECTION, THE LOOP WAS FOUND TO BE BURNT AND HAD BROKEN. THE DETACHED FRAGMENT WAS IDENTIFIED AND RETRIEVED. THE INCIDENT ADDED APPROXIMATELY 10 MINUTES TO THE PROCEDURE TIME AND THERE WAS NO INJURY NOTED, HOWEVER THE SURGEON IS CONCERNED ABOUT BURNED FRAGMENTS AND POSSIBLE THERMAL INJURY TO THE ENDOMETRIUM WHICH COULD INCREASE THE RISK OF INTRAUTERINE ADHESIONS."