ELECTRODE, BIPOLAR
Received Apr 17, 2026 · Event occurred Mar 12, 2026
Report 9610617-2026-00859 · MDR key 24907354
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011050-10Catalog number
011050-10
Lot number
843018
Product problems
- Break
Patient
Not reported
- 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 "DURING A HYSTEROSCOPY PROCEDURE TO REMOVE A FIBROID, THE DOCTOR REQUESTED THE USE OF A MINI RESECTOSCOPE WITH ITS RESPECTIVE DISPOSABLE PARTS. TWO UNITS OF PRODUCT CODE 011050-01, DESCRIBED AS A BIPOLAR HALF-MOON LOOP, LOT 843018, WERE USED. HOWEVER, AT THE MOMENT OF INSERTION INTO THE PATIENT, BOTH LOOPS PRESENTED A STRUCTURAL FAILURE (BREAKAGE), MAKING THEIR USE IMPOSSIBLE DURING THE PROCEDURE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE CROSS REFERENCE 9610617-2026-839.