MalfunctionFAS
ELECTRODE, BIPOLAR
Received May 13, 2026 · Event occurred Apr 28, 2026
Report 9610617-2026-01104 · MDR key 25165618
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011050-10Catalog number
011050-10
Lot number
864961
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "DURING A GYNECOLOGICAL RESECTION, A LOOP BROKE. THE SURGEON HAD TO REPLACE THE LOOP AND RETRIEVE THE FRAGMENTS DURING THE SAME PROCEDURE. THE PROCEDURE WAS NOT PROLONGED, AND NO X-RAYS WERE REQUIRED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
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).