CUTTING LOOP, BIPOLAR, F/USE W/26053EB
Received Jun 8, 2026
Report 9610617-2026-01290 · MDR key 25438254
Device
Generic name
Cutting Loop, Bipolar, F/use W/26053eb
Manufacturer
Karl Storz Se & Co. KgModel number
011050-01Catalog number
011050-01
Lot number
858264
Product problems
- Material Fragmentation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A RESECTION WAS PERFORMED DURING A LAPAROSCOPIC MYOMECTOMY. DURING THE PROCEDURE, THE LOOP DETACHED FROM ITS BASE. AS A RESULT, THE SURGERY WAS PROLONGED TO ALLOW FOR RETRIEVAL OF THE DETACHED LOOP AND THE REQUIRED INSTRUMENTS. THE DEVICE WAS SUBSEQUENTLY REPLACED WITH A NEW LOOP. 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).