ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR
Received Feb 20, 2025 · Event occurred Jan 29, 2025
Report 9610617-2025-00255 · MDR key 21426840
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Endoscopy-america, Inc.Model number
011160-10Catalog number
011160-10
Lot number
852734
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE INITIAL MDR FOR THIS CASE WAS SUBMITTED BY MISTAKE. THE CORRECT MDR THAT WERE SUBMITTED FOR THIS EVENT IS IN MDR 25-261 INTERNAL REFERENCE NUMBER (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 BIPOLAR LOOP BROKE SPONTANEOUSLY DURING AN OPERATIVE PROCEDURE. THE BROKEN PIECE IN THE BLADDER WAS REMOVED. DELAY PROCEDURE, NEW LOOP USED FOR THE CONTINUATION OF THE SURGICAL PROCEDURE. NO INFORMATION ON LENGTH OF SURGICAL DELAY OR PROLONGATION OF SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY OR HARM REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. THEREFORE THIS CASE IS NOT REPORTABLE IN FRANCE.