ELECTRODE, BIPOLAR
Received Apr 15, 2026 · Event occurred Mar 25, 2026
Report 2020550-2026-00846 · MDR key 24889539
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011050-10Catalog number
011050-10
Lot number
857983
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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).
Description of Event or Problem
IT WAS REPORTED THAT A BIPOLAR ELECTRODE FRACTURED INSIDE THE PATIENT. THE THEATRE STAFF REPORTED THAT SMALL FRAGMENTS FROM THE ELECTRODE HAD DETACHED AND REMAINED WITHIN THE PATIENT. THE PROCEDURE WAS BEING CARRIED OUT USING A B BRAUN STACK SYSTEM, A COVIDIEN BIPOLAR MACHINE. THERE WAS A DELAY LONGER THAN 60 MINUTES WHILE THEATRE STAFF WORKED TO CONFIRM THAT ALL FRAGMENTS HAD BEEN SUCCESSFULLY RETRIEVED FROM THE PATIENT.