BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO

    MDR report key: 1962999 · Received January 5, 2011

    Report

    Report Number
    1962999
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 5, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    AUTOSUTURE CLIPS WERE CROSSING ON CLOSURE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEVICE MALFUNCTION.====================== MANUFACTURER RESPONSE FOR AUTO SUTURE, TYCO======================NO RESPONSE TO MESSAGES SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO CLIP APPLIER GDO COVIDIEN 176657 N0E0033

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWN.