ELECTRODE, BIPOLAR
Received Mar 13, 2026
Report 2020550-2026-00562 · MDR key 24599378
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011050-10Catalog number
011050-10
Lot number
858491
Product problems
- Break
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
THE FOLLOWING WAS REPORTED: DURING AN OPERATIVE HYSTEROSCOPY, A 5 MM RESECTION LOOP REF. (B)(4) (LOT NO. 858491, EXP 30.11.2029) BROKE DURING THE PROCEDURE. THE SURGEON PERFORMED A VERIFICATION ENDOSCOPICALLY, DIGITALLY, AND VISUALLY, BUT THE LOOP WAS NOT FOUND. DUE TO THE FACT THAT FRAGMENTS OR BROKEN PARTS MAY HAVE BEEN LEFT BEHIND IN THE PATIENT, THIS CASE IS DEEMED REPORTABLE.