inforMED
MalfunctionDGW

PROXIMATE ILS CIRCULAR STAPLERS

Received May 10, 2006 · Event occurred Apr 13, 2006

Report 1527736-2006-02093 · MDR key 715495

Device

Generic name

Gdw

Model number

NA

Catalog number

CDH33

Lot number

C4D600

Product problems

  • Replace
  • Source, detachment from

Patient

UNKNOWN

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING A PROCTOCOLECTOMY WITH ILEO-ANAL POUCH PROCEDURE. THE SURGEON WAS PERFORMING AN END TO END ILEO-ANAL POUCH ANASTOMOSIS AS PART OF A PROTOCOLECTOMY. THE PURSE STRING WAS TIED AROUND THE ANVIL, AND THE GUN SUCCESSFULLY INSERTED TRANSANALLY. THE ANVIL WAS ATTACHED TO THE TROCAR, AND THE SURGEON BEGAN TO CLOSE THE GUN. ONLY ONE OR TWO FULL TURNS OF THE GUN WHERE ALLOWED HOWEVER WHENT HE ANVIL BECAME DETACHED FROM THE TROCAR. SEVERAL ATTEMPTS THE GUN WAS NOT ABLE TO CLOSE. ANOTHER GUN WAS OPENED AND USED WITH THE SAME ANVIL HEAD, AND CLOSED AND FIRED WITHOUT PROBLEM IS HOW THE CASE WAS COMPLETED. NO PT CONSEQUENCE.

Remedial action

  • Other