BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 2862797 · Received November 21, 2012

    Report

    Report Number
    2862797
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ETHICON ENDO-SURGERY
    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 HALF WAY THROUGH THE CASE. THE PHYSICIAN ASKED FOR THE DEVICE TO BE REPACKAGED TO RETURN TO THE REPRESENTATIVE AND A SECOND DEVICE TO BE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO ELECTROSURGICAL, CUTTING, COAGULATION GEI ETHICON ENDO-SURGERY ETRIO 335H *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR