ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR
Received Feb 19, 2025 · Event occurred Jan 31, 2025
Report 9610617-2025-00254 · MDR key 21414794
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Endoscopy-america, Inc.Model number
011160-10Catalog number
011160-10
Product problems
- Break
- Detachment of Device or Device Component
- Break
- Detachment of Device or Device Component
Patient
NA · Unknown
- Dysuria
- Foreign Body In Patient
- Dysuria
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
DEVICE EVALUATION: THE PRODUCT WAS RETURNED FOR INVESTIGATION ON FEBRUARY 17, 2025. THE INVESTIGATION WAS COMPLETED ON MARCH 18, 2025. ONLY THE CUTTING LOOP HAS BEEN RETURNED. THE WHOLE BODY IS MISSING. THE CUTTING LOOP IS BROKEN OFF AT THE EXIT OF THE YELLOW INSULATION. THE BROKEN SURFACE SHOWS A DUCTILE APPEARANCE. AS THE BROKEN SURFACE SHOWS A DUCTILE APPEARANCE - SIGN OF A BREAK BY FORCE - IT IS MOST LIKELY THAT THE ELECTRODE GOT EXPOSED TO EXCESSIVE FORCE DURING APPLICATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PIECE OF THE BIPOLAR LOOP WAS FOUND IN THE PATIENT'S URETER DURING CYSTOSTOSCOPY. THE PATIENT UNDERWENT SURGERY IN (B)(6) 2024. IN (B)(6) 2025 HE UNDERWENT A CYSTOSCOPY BECAUSE HE WAS NO LONGER ABLE TO URINATE. DURING THE CYSTOSCOPY, THE SURGEON FOUND A PIECE OF A BIPOLAR LOOP IN THE URETER. THIS PIECE WAS REMOVED FROM THE URETHRA AND URINATION RESUMED. BECAUSE OF THE ADDITIONAL SURGERY A RE-HOSPITALIZATION AND THE DYSURIA THE EVENT IS DEEMED REPORTABLE.