BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 3101852 · Received May 6, 2013

    Report

    Report Number
    3101852
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 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

    A POSITIVE ELECTRODE SEPARATED FROM THE SEALING DEVICE. THE DEVICE WAS EXAMINED BY MD AND REMOVED FROM SURGICAL FIELD. A NEW DEVICE WAS OBTAINED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197435 ENSEAL TRIO ELECTROSURGICAL, CUTTING, COAGULATION GEI ETHICON ENDO-SURGERY, INC. ETHRIO335H *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR