MalfunctionFAS
ELECTRODE, BIPOLAR
Received May 13, 2026 · Event occurred Apr 27, 2026
Report 9610617-2026-01099 · MDR key 25163702
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011050-10Catalog number
011050-10
Lot number
859194
Product problems
- Material Fragmentation
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 TIP OF THE RESECTION LOOP BROKE INSIDE THE PATIENT. THE FRAGMENT WAS REMOVED SUCCESSFULLY.