PROXIMATE ILS CIRCULAR STAPLERS
Received May 10, 2006 · Event occurred Apr 13, 2006
Report 1527736-2006-02093 · MDR key 715495
Device
Generic name
Gdw
Manufacturer
Ethicon Endo Surgery, Inc.Model number
NACatalog 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