MalfunctionFHM
ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM
Received Aug 12, 2008 · Event occurred Jun 12, 2008
Report 3005075853-2008-01120 · MDR key 1112766
Device
Product problems
- Positioning Failure
- Replace
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE FIRED AS EXPECTED, BUT WHEN THE STAPLER REMOVED THERE WERE NO STAPLES FOUND WITHIN THE ANASTAMOSIS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Additional Manufacturer Narrative
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.