ELECTRODE,BIPOLAR,CUTTING LOOP
Received Mar 11, 2026 · Event occurred Feb 23, 2026
Report 9610617-2026-00514 · MDR key 24573336
Device
Generic name
Electrode,bipolar,cutting Loop
Manufacturer
Karl Storz Se & Co. KgModel number
011160-10Catalog number
011160-10
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A TURP PROCEDURE THE SURGEON OBSERVED THAT THE BIPOLAR CUTTING LOOP WAS BROKEN AFTER IT WAS INSERTED INTO THE INSTRUMENT THAT IS USED FOR RESECTION OF THE PROSTATE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
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).
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IS PROVIDED IN SECTION B5. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
CROSS REFERENCE MDR: (B)(4).