PKG, METZENBAUM SCISSORS, CURVED LONG
Received Dec 16, 2019 · Event occurred Nov 19, 2019
Report 0002936485-2019-00559 · MDR key 9474606
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Stryker Endoscopy-san JoseModel number
0250080265Catalog number
0250080265
Lot number
NR
Product problems
- Break
Patient
Not reported
- Foreign Body In Patient
- No Known Impact Or Consequence To Patient
- Foreign Body In Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE TIP OF THE SCISSOR BROKE OFF. THE BROKEN PIECES WERE RETRIEVED.
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: TIP BROKE. PROBABLE ROOT CAUSE: POOR AUTOCLAVE RELIABILITY. SHEAR PIN FAILURE IN HANDLE. USE ERROR. DAMAGE DURING MANUFACTURING/ SERVICING. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN. H3 OTHER TEXT : 81.
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.
Description of Event or Problem
IT WAS REPORTED THAT THE TIP OF THE SCISSOR BROKE OFF. THE BROKEN PIECES WERE RETRIEVED.