AUTO ENDO5 ML
Received Nov 1, 2013 · Event occurred Oct 23, 2013
Report 3003898360-2013-00514 · MDR key 3532508
Device
Product problems
- Component Falling
- Difficult to Advance
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: CLIP WAS NOT LOADING PROPERLY AND WOULD FALL OUT OF THE APPLIER. NO PT INJURY REPORTED. PT CURRENT CONDITION IS FINE.
Additional Manufacturer Narrative
NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ANY ISSUES RELATED TO THIS COMPLAINT. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, HOWEVER, WE WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.