MalfunctionGDW
BIOPRO MEMORY STAPLE
Received Oct 15, 2012 · Event occurred Sep 20, 2012
Report 1833506-2012-00003 · MDR key 2796352
Device
Product problems
- Device Operates Differently Than Expected
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
STAPLE WAS REMOVED AND REPLACED BECAUSE THE DOCTOR FELT THAT IT DID NOT COMPRESS PROPERLY.
Additional Manufacturer Narrative
THE EIGHT STAPLES FROM SAME LOT WERE TESTED AND ALL STAPLES FUNCTIONED AS INTENDED FOR USE.
Remedial action
- Replace