PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION
Received Feb 9, 2022 · Event occurred Jan 13, 2022
Report 0002936485-2022-00069 · MDR key 13502178
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Stryker Endoscopy-san JoseModel number
0250080311Catalog number
0250080311
Lot number
NOT REPORTED
Product problems
- Material Fragmentation
- Material Fragmentation
- Device Fell
Patient
Unknown
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
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 SCREW FELL OUT AND POTENTIALLY REMAINED INSIDE THE PATIENT.
Description of Event or Problem
IT WAS REPORTED THAT SCREW FELL OUT AND POTENTIALLY REMAINED INSIDE THE PATIENT.
Additional Manufacturer Narrative
THE DEVICE MANUFACTURE DATE IS NOT KNOWN. 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: MID-CASE A SCREW WAS LOOSENED FROM A MANUAL LAP INSTRUMENT. THE SCREW WAS LOST IN THE PATIENT. PROBABLE ROOT CAUSE: USE ERROR. MANUFACTURING/ SERVICING ERRORS. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.