ELECTRODE, BIPOLAR
Received May 20, 2026 · Event occurred Apr 27, 2026
Report 9610617-2026-01138 · MDR key 25236248
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011160-10Catalog number
011160-10
Lot number
854979
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO 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).
Description of Event or Problem
IT WAS REPORTED THAT "DURING THE TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) PROCEDURE OF PATIENT THE PRODUCT "BIPOLAR MTP LOOP ELECTRODE 24/26FR (STERILE), REF. (B)(4)- KARL STORZ" WAS OPENED AND PRESENTED A RUPTURE DURING USE. DUE TO THIS OCCURRENCE, IT WAS NECESSARY TO RETRIEVE A SECOND UNIT FROM THE PHARMACY IN ORDER TO COMPLETE THE PROCEDURE.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.