ELECTRODE,BIPOLAR,CUTTING LOOP
Received Jul 1, 2026 · Event occurred Jun 16, 2026
Report 2020550-2026-01473 · MDR key 25677651
Device
Generic name
Electrode,bipolar,cutting Loop
Manufacturer
Karl Storz Se & Co. KgModel number
011160-10Catalog number
011160-10
Lot number
864790
Product problems
- Detachment of Device or Device Component
Patient
53 YR · Female
- Foreign Body In Patient
Narrative
Description of Event or Problem
THE FOLLOWING WAS REPORTED A BIPOLAR RESECTOSCOPE PROCEDURE THAT RESULTED IN A PART OF THE LOOP BREAK OFF INSIDE THE PATIENT'S UTERUS. IT HAD A NEGATIVE IMPACT ON THE PATIENT AND THE SURGEON HAD TO CANCEL FOLLOWING CASE AS A RESULT. 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. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).