BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN 8" ANASTAMOSIS NEEDLE HOLDER

    MDR report key: 2250833 · Received September 1, 2011

    Report

    Report Number
    2250833
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 17, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ETHICON
    Product Code
    GDF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN 8" ANASTAMOSIS NEEDLE HOLDER GUIDE, NEEDLE, SURGICAL GDF ETHICON 9406N *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR