ELECTRODE, BIPOLAR
Received Apr 16, 2026 · Event occurred Feb 3, 2026
Report 9610617-2026-00852 · MDR key 24904150
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011050-10Catalog number
011050-10
Lot number
858491
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Description of Event or Problem
THIS MICRO DISSECTOR WAS TOO FRAGILE FOR THE POLYP TO BE REMOVED, AND A SECOND SNARE WAS REQUIRED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT; THE SNARE THAT HAD BECOME MOBILE (AND THEREFORE INEFFECTIVE) WAS REPLACED, NOTHING REMAINED INSIDE THE PATIENT, AND NO ADDITIONAL INJURY OCCURRED. THE PROCEDURE WAS SLIGHTLY LONGER (BUT NEGLIGIBLE). THE ONLY CONSEQUENCE WAS THE USE OF TWO SNARES INSTEAD OF ONE FOR THE PROCEDURE.
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).