PKG, METZENBAUM SCISSORS, CURVED LONG
Received Feb 5, 2025 · Event occurred Jan 7, 2025
Report 0002936485-2025-00084 · MDR key 21316006
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Stryker Endoscopy-san JoseCatalog number
0250080265
Lot number
2344683
Product problems
- Break
- Material Fragmentation
- Break
- Material Fragmentation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. THE BROKEN PIECE(S) WERE SUCCESSFULLY REMOVED.
Additional Manufacturer Narrative
THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative
THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: SCISSOR BROKE IN HALF DURING SURGERY. PROBABLE ROOT CAUSE: USE ERROR. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. THE BROKEN PIECE(S) WERE SUCCESSFULLY REMOVED.