PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION
Received Dec 26, 2019 · Event occurred Dec 2, 2019
Report 0002936485-2019-00597 · MDR key 9522217
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Stryker Endoscopy-san JoseModel number
0250080311Catalog number
0250080311
Lot number
1042193
Product problems
- Break
- Break
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: GOOD AFTERNOON, A LOCKING D&G IN A DR. PRATT ROBOTIC HERNIA CASE BROKE APART IN THE PATIENT JUST NOW HERE IS THE PICTURE OF THE INSTRUMENT COMPARED TO ANOTHER. I BELIEVE THE VA WILL BE FILING AN INCIDENT REPORT. THIS HAS NOT HAPPENED HERE BEFORE, LET ME KNOW HOW TO PROCEED. THE FAILURE 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 DEVICE MANUFACTURE DATE IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A POTENTIAL FOR PIECES OF THE DEVICE BEING LEFT IN 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 THERE WAS A POTENTIAL FOR PIECES OF THE DEVICE BEING LEFT IN THE PATIENT.