BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 2992114 · Received March 1, 2013

    Report

    Report Number
    2992114
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    PRIOR TO USING THE DEVICE, THE SURGEON NOTICED THE DEVICE WAS NOT OPERATING PROPERLY. UPON EXAMINING THE DEVICE, IT WAS NOTED THE TIP WAS BROKEN. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89429 ENSEAL TRIO ELECTROSURGICAL, COAGULATION, CUTTING GEI ETHICON ENDO-SURGERY, INC. ETRIO335H *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR