inforMED
InjuryFDW

ENDO GIA ULTRA UNIVERSAL STAPLER

Received Nov 16, 2010 · Event occurred Nov 12, 2010

Report MW5018252 · MDR key 1905797

Device

Generic name

Stapler

Manufacturer

Covidien

Model number

NOFO362UJ

Lot number

NOH0221

Product problems

  • Difficult to Remove

Patient

86 YR

  • Tissue Damage

Narrative

Description of Event or Problem

DURING A THORACOTOMY FOR BLEB STAPLING, THE SURGEON DEPLOYED THE STAPLER IT WOULD NOT RELEASE. THE SURGEON HAD TO EXCISE MORE TISSUE AROUND THE RETAINED STAPLER TO GET IT OUT OF THE CHEST RESULTING IN MORE LUNG BEING REMOVED FROM THE PT THAT WAS NOT NECESSARY FOR THE PROCEDURE ITSELF.