inforMED
InjuryFHM

TA 90 B REUSABLE INSTRUMENT

Received Nov 3, 2011 · Event occurred Aug 31, 2011

Report 1219930-2011-00967 · MDR key 2338072

Device

Generic name

Disposable Surgical Stapling Device

Catalog number

010884

Product problems

  • Device Operates Differently Than Expected

Patient

Not reported

  • Tissue Damage

Narrative

Description of Event or Problem

PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE STAPLER MALFUNCTIONED WHILE FIRING THE CARTRIDGE. THE STAPLES DID NOT FIRE PROPERLY. THE STAPLER NOW DOES NOT LOAD PROPERLY NOR FIRE ACCURATELY AS IT DEFLECTS THE ANVIL. THIS HAPPENED TWICE WITH BOTH UNITS. THE UNITS FEEL FLIMSY AND METAL WORK IS NOT PARALLEL ACCORDING TO THE REPORTER. THE PT IS FINE. TISSUE DAMAGE TO THE GASTRIC POUCH OCCURRED; HOWEVER, IT WAS CORRECTED BY REAPPLICATION WHEN ANOTHER DEVICE WAS OPENED AND RE-APPLIED.

Additional Manufacturer Narrative

(B)(4).