CUTTING LOOP, BIPOLAR, 24/26 FR.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WILL NO BE RETURNED TO MANUFACTURER. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

DURING THE OPERATION, THE CUTTING LOOP FRACTURED AND A PART WAS MISSING. INTRAOPERATIVE CT SHOWED THAT THE MISSING PART OF THE CUTTING LOOP WAS RETAINED IN THE PATIENT'S MUSCULAR LAYER, POSING A POTENTIAL SAFETY RISK. THE RESIDUAL PART WAS IMMEDIATELY REMOVED AND CLEANED UP. INFORMATION WAS PROVIDED THAT THE PROCEDURE WAS PROLONGED 2 HOURS. ALSO THERE WAS DAMAGE TO THE TISSUE DUE TO THE BREAKAGE. THE CUTTING LOOP FRACTURED AND WAS RETAINED IN THE PATIENT'S MUSCULAR LAYER. IT WAS NOT FOUND DURING HYSTEROSCOPY. AFTER BEING LOCATED BY CT, IT WAS REMOVED, CAUSING CERTAIN SEVERE TISSUE DAMAGE TO THE PATIENT.