CUTTING ELECTRODE, BIPOLAR, 26 FR.

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

THE FOLLOWING WAS REPORTED: AT 13:00 ON (B)(6) 2026, DURING THE RESECTOSCOPY FOR UTERINE SUBMUCOUS MYOMA, THE ELECTRODE OF THE RESECTOSCOPE LOOP FRACTURED AND DETACHED. AN IMMEDIATE SEARCH WAS CONDUCTED ON SITE, AND THE OPERATING ROOM HEAD NURSE WAS REPORTED SIMULTANEOUSLY. THE HEAD NURSE INSTRUCTED TO CHECK THE UTERINE CAVITY AND THE SPECIAL BUCKET FOR UTERINE CAVITY IRRIGATION FLUID. NO DETACHED ELECTRODE WAS FOUND IN THE UTERINE CAVITY AFTER EXAMINATION BY THE PHYSICIAN. SUBSEQUENTLY, THE NURSE FOUND THE ATTACHED ELECTRODE LOOP ON THE GAUZE FILTERING THE IRRIGATION FLUID. AFTER JOINT VERIFICATION ON SITE WITH THE PHYSICIAN, IT WAS CONFIRMED TO BE THE COMPLETE FRACTURED AND MISSING ELECTRODE LOOP. AFTER THE OPERATION, THE NURSE AND THE PHYSICIAN VERIFIED THE INSTRUMENTS AGAIN WITHOUT ERROR, AND THE PATIENT WAS SAFELY TRANSFERRED BACK TO THE WARD. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.