PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT
Received Jun 22, 2020 · Event occurred May 26, 2020
Report 0002936485-2020-00239 · MDR key 10180017
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Stryker Endoscopy-san JoseModel number
0250080234Catalog number
0250080234
Lot number
14403520
Product problems
- Break
- Break
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
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: GRASPER BROKE. PROBABLE ROOT CAUSE: PATIENT ANATOMY, PORTAL LOCATION, INCORRECT INSTRUMENT DIAMETER/LENGTH, MANUFACTURING/ SERVICING ERROR, USE ERROR. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT A PIECE WAS POTENTIALLY LEFT INSIDE THE PATIENT. IT WAS NOT CONFIRMED WHETHER SMALL FRAGMENTS REMAINED WITHIN THE PATIENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
Description of Event or Problem
IT WAS REPORTED THAT A PIECE WAS POTENTIALLY LEFT INSIDE THE PATIENT. IT WAS NOT CONFIRMED WHETHER SMALL FRAGMENTS REMAINED WITHIN THE PATIENT.