33CM DORSEY GRASPER FORCEPS
Received Apr 4, 2025 · Event occurred Feb 7, 2025
Report 0002936485-2025-00282 · MDR key 21774504
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Stryker Endoscopy-san JoseCatalog number
0250080319
Lot number
152099
Product problems
- Break
- Material Fragmentation
- Break
- Material Fragmentation
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. THE BROKEN PIECES WERE SUCCESSFULLY 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.
Additional Manufacturer Narrative
ALLEGED FAILURE: THE DORSEY JAW BROKE WHILE INSIDE THE PATIENT. SURGEON SAID HE WAS TRYING TO PULL OUT A MINI-LAP FROM PATIENT AND THAT'S WHEN THE JAW BROKE. THE BROKEN PIECES WERE SUCCESSFULLY RETRIEVED. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE COULD BE EXCESSIVE FORCE APPLIED BY USER. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ADDED INITIAL REPORTER PHONE NUMBER. THE MANUFACTURER DATE IN NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. THE BROKEN PIECES WERE SUCCESSFULLY RETRIEVED.