ELECTRODE, BIPOLAR
Received Jun 5, 2026 · Event occurred May 21, 2026
Report 9610617-2026-01293 · MDR key 25410555
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011160-10Catalog number
011160-10
Lot number
854217
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE BIPOLAR LOOP BROKE DURING A SURGICAL MYOMECTOMY. IN TOTAL, FIVE CUTTING LOOPS BROKE DURING REPEATED ATTEMPTS AT RESECTION. DESPITE THESE OCCURRENCES, THE RESECTOSCOPE WAS COMPLETELY REMOVED. IT WAS CONFIRMED THAT NO FRAGMENTS OR RESIDUAL PARTS REMAINED IN THE PATIENT'S BODY.