BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3840243 · Received April 30, 2014

    Report

    Report Number
    3840243
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    October 15, 2013
    Report Date
    February 27, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE HANDLE BROKE WHEN TRYING TO STAPLE THE PATIENT'S RECTUM. THE DEVICE WAS REMOVED FROM THE FIELD, AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258168 CONTOUR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, INC. * K4CG4P

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR