PKG, BABCOCK FORCEPS
Received Apr 27, 2022 · Event occurred Feb 9, 2022
Report 0002936485-2022-00204 · MDR key 14219442
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Stryker Endoscopy-san JoseModel number
0250080321Catalog number
0250080321
Lot number
UNK
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 THE DEVICE BREAKING INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE BREAKING INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED.
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: BABROCK BROKEN PROBABLE ROOT CAUSE: USE ERROR MANUFACTURING/ SERVICING ERRORS THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN. H3 OTHER TEXT : 81.