KNIFE, STRAIGHT
Received May 12, 2026 · Event occurred Apr 21, 2026
Report 9610617-2026-01081 · MDR key 25152502
Device
Product problems
- Break
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
THE FOLLOWING WAS REPORTED: "DURING A URETHROTOMY, THE BLADE BROKE OFF AND INITIALLY REMAINED UNNOTICED IN THE PATIENT'S URETHRA. THE DEFECT WAS NOT DISCOVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. POSTOPERATIVELY THE PATIENT REPORTED THAT HE HAD PASSED A METAL FRAGMENT APPROXIMATELY 2.5 CM LONG." ACCORDING TO THE USER, THIS FRAGMENT BROKE OFF DIRECTLY AT THE WELD JOINT OF THE ARTICULATION MECHANISM DURING THE SURGERY.
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).