BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 3120099 · Received May 14, 2013

    Report

    Report Number
    3120099
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HALF OF JAW CAME APART IN THE MIDDLE OF THE CASE; NEW ENSEAL OPENED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC LEFT HEMICOLECTOMY, POSSIBLE OPEN, POSSIBLE OSTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212872 ENSEAL TRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES, TISSUE GEI ETHICON ENDO-SURGERY, INC. * K4C69U

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR NO OTHER THERAPIES