BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 2925030 · Received December 27, 2012

    Report

    Report Number
    2925030
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 19, 2012
    Report Date
    December 24, 2012
    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

    DEVICE STOPPED WORKING DURING A CASE AND WAS REMOVED FROM THE FIELD. A SECOND DEVICE WAS OPENED PER THE PHYSICIAN'S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO ELECTROSURGICAL, CUTTING, COAGULATION GEI ETHICON ENDO-SURGERY, INC. ENTRIO345H J4C57K

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR