inforMED
MalfunctionFHM

ENDOPATH STEALTH CIR STAPLER

Received Aug 11, 2008 · Event occurred Jul 22, 2008

Report 3005075853-2008-01072 · MDR key 1112644

Device

Model number

NA

Catalog number

ECS25

Lot number

C4DF7F

Product problems

  • Crack
  • Replace

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING A LAP ROUX-EN-Y PROCEDURE, THE BLUE TIP HAD A CRACK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

Additional Manufacturer Narrative

INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.