MalfunctionFAS
ELECTRODE, BIPOLAR
Received May 19, 2026 · Event occurred May 4, 2026
Report 9610617-2026-01135 · MDR key 25219907
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011160-01Catalog number
011160-01
Lot number
864013
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 RESECTION LOOP BROKE IN THE UTERUS. THE FOREIGN BODY WAS RETRIEVED".