BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM

    MDR report key: 1891785 · Received October 28, 2010

    Report

    Report Number
    1891785
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 28, 2010
    Manufacturer
    TYCO HEALTHCARE-US SURGICAL
    Product Code
    ODE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC GASTRIC BYPASS, THE ENDOSTITCH NEEDLE BROKE IN HALF. THE NEEDLE BROKE IN HALF WHILE IN USE. HALF OF THE NEEDLE WAS STUCK IN THE TIP OF THE DEVICE AND THE OTHER HALF WAS IN THE PT'S ABDOMEN. THE RETAINED PIECE WAS RETRIEVED AND BOTH PIECES WERE COMPARED TO AN INTACT NEEDLE. IT APPEARED AS IF BOTH PIECES EQUALED THE SIZE OF AN INTACT NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM ENDOMECHANICAL ODE TYCO HEALTHCARE-US SURGICAL 173016 NOF0379

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR