MalfunctionFAS
ELECTRODE, BIPOLAR
Received Jun 5, 2026 · Event occurred May 4, 2026
Report 9610617-2026-01304 · MDR key 25418001
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011050-10Catalog number
011050-10
Lot number
858264
Product problems
- Detachment of Device or Device Component
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 RESECTION LOOP BROKE DURING AN INTRAUTERINE OPERATIVE HYSTEROSCOPY PROCEDURE. THE BROKEN PART WAS RETRIEVED WITHOUT INJURY TO PATIENT REPORTED. PROCEDURE COMPLETED WITH LESS THAN 15 MINS DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.