inforMED
InjuryFAS

ELECTRODE, BIPOLAR

Received May 22, 2026 · Event occurred May 4, 2026

Report 2020550-2026-01184 · MDR key 25262824

Device

Generic name

Electrode, Bipolar

Model number

011160-01

Catalog number

011160-01

Lot number

864013

Product problems

  • Break

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT "THE BIPOLAR RESECTION LOOP BROKE IN THE UTERUS. THE FOREIGN BODY WAS RETRIEVED".

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).