'PKG, DEBAKEY FORCEPS'
Received Mar 22, 2021 · Event occurred Feb 22, 2021
Report 0002936485-2021-00161 · MDR key 11548075
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Stryker Endoscopy-san JoseModel number
0250080314Catalog number
0250080314
Lot number
1342844
Product problems
- Break
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ALLEGED FAILURE: DEBAKEY INSERT BROKE INTRAOPERATIVELY THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES COULD BE EXCESSIVE FORCE, OR ROTATIONAL FORCE WITH THE JAW UNDER LOAD. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THE DEVICE BROKE DURING PROCEDURE. ADDITIONAL INFORMATION CONFIRMED THAT THE PIECES WERE RETRIEVED.
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 THE DEVICE BROKE DURING PROCEDURE. ADDITIONAL INFORMATION CONFIRMED THAT THE PIECES WERE RETRIEVED.