ELECTRODE, BIPOLAR
Received Apr 24, 2026 · Event occurred Mar 23, 2026
Report 2020550-2026-00845 · MDR key 24984435
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011168-10Catalog number
011168-10
Lot number
858053
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING A PROSTATE RESECTION USING THE THULEP TECHNIQUE AND THE SPECIFIC BIPOLAR RESECTION LOOP, THE LOOP BROKE INSIDE THE PATIENT WHEN THE SURGEON ATTEMPTED TO RETRIEVE A PROSTATE CHIP. THE SURGEON THEN HAD TO RECOVER THE SMALL BROKEN FRAGMENT USING A SINGLE USE FLEXIBLE FOREIGN BODY FORCEPS.
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).