'PKG, DEBAKEY FORCEPS'
Received Jun 19, 2019 · Event occurred May 22, 2019
Report 0002936485-2019-00248 · MDR key 8713424
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Stryker Endoscopy-san JoseCatalog number
0250080314
Lot number
UNKNOWN
Product problems
- Break
Patient
Not reported
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
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: BROKE GRASPER. - PROBABLE ROOT CAUSE: - INCORRECT PACKAGING - SEVERE SHIPPING CONDITIONS - USE ERROR. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE RE-OCCURRENCE. THE DEVICE MANUFACTURER DATE IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT A PIECE BROKE AND REMAINED INSIDE 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 A PIECE BROKE AND REMAINED INSIDE THE PATIENT.