ELECTRODE, BIPOLAR
Received Mar 30, 2026
Report 9610617-2026-00668 · MDR key 24708754
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
IT WAS REPORTED THAT PRODUCT BROKE INTO THE PATIENT. HOWEVER, NO INFORMATION ABOUT IF PRODUCT WAS RECOVERED AND THERE IS NO INFORMATION ABOUT HARM OR INJURY TO PATIENT REPORTED. THEREFORE, THIS CASE IS REPORTABLE AS PRECAUTION.
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. 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).