BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE

    MDR report key: 1171704 · Received September 11, 2008

    Report

    Report Number
    1171704
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 11, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GALLBLADDER PROCEDURE THE AUTOSUTURE CLIP APPLIER DID NOT WORK PROPERLY. THE CLIPS WERE SLIDING OFF THE DUCT AND THEN THE APPLIER STOPPED FIRING THE CLIPS. A SECOND CLIP APPLIER WAS USED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE CLIP APPLIER GDO COVIDIEN UNITED STATES SURGICAL CORPORATION ENDO CLIP III U8C91

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR