MalfunctionOCU
ENDOSTITCH
Received Sep 22, 2016 · Event occurred Sep 14, 2016
Report 5969603 · MDR key 5969603
Device
Product problems
- Positioning Failure
- Device Slipped
- Device Operates Differently Than Expected
Patient
65 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THERE WAS DIFFICULTY LOADING THE SUTURE. ONCE SUTURE WAS LOADED AND INSERTED THE NEEDLE WAS USED, BUT FELL OFF OF THE ENDOSTITCH ON THE FIRST PASS THROUGH THE TISSUE.