inforMED
MalfunctionGDF

CODMAN 8" ANASTAMOSIS NEEDLE HOLDER

Received Sep 1, 2011 · Event occurred Aug 17, 2011

Report 2250833 · MDR key 2250833

Device

Generic name

Guide, Needle, Surgical

Manufacturer

Ethicon

Model number

9406N

Catalog number

*

Lot number

*

Product problems

  • Component Missing

Patient

82 YR

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

DURING CHOLECYSTECTOMY, A PAD WAS FOUND MISSING FROM THE TIP OF AN ANASTAMOSIS NEEDLE HOLDER. KUB SHOWED A 5 MM METALLIC DENSITY PROJECTING IN THE RIGHT UPPER QUADRANT JUST SUPERIOR TO THE SKIN CLIPS, CONSISTENT WITH THE TINY TIP OF AN INSTRUMENT. SURGEON REPORTED THAT ONE OF THE TECHNICIANS DID NOTICE THAT A NEEDLE HOLDER HAD A PAD ON IT, AND IT WAS LOST. SURGEON REVIEWED THE FILM AND WAS NOT SURE AT WHAT LEVEL IT WAS, WHETHER IT WAS IN THE SKIN OR DEEP IN THE ABDOMEN, BUT IT WAS METALLIC, WHICH WAS OVER THE NEEDLE HOLDER WHERE ONE HOLDS THE NEEDLE. SURGEON OPTED NOT TO GO BACK IN TO RETRIEVE IT. STATED THAT IT APPEARED TO BE SMALLER THAN THE TITANIUM CLIPS THAT WERE USED.