BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE ENDO STITCH

    MDR report key: 1221425 · Received October 31, 2008

    Report

    Report Number
    1221425
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 2, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE ON THE ENDOSTITCH WOULD SHUTTLE FROM ONE ARM OF THE DEVICE TO THE OTHER BUT THE TISSUE WOULD NOT RELEASE FROM THE NEEDLE. THE NEEDLE BROKE IN ORDER TO GET THE TISSUE OUT AND CAUSED A HOLE IN THE STOMACH. THIS HAPPENED BEFORE, BUT WAS ABLE TO RELEASE THE TISSUE WITHOUT BREAKING THE NEEDLE OR CAUSING A HOLE IN THE STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDO STITCH SUTURE DEVICE MFJ COVIDIEN UNITED STATES SURGICAL CORPORATION ENDO STITCH N8E227

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR NO OTHER THERAPIES| NO OTHER THERAPIES