BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL

    MDR report key: 4091591 · Received August 13, 2014

    Report

    Report Number
    4091591
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 13, 2014
    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 BROKE AT JAW HINGE DURING SURGERY. NO HARM TO PATIENT. HAD TO REPLACE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482354 ENSEAL ELECTROSURGICAL, CUTTING, COAGULATION GEI ETHICON ENDO-SURGERY, INC. * L4EN55

    Patients

    Seq Age Sex Outcome Treatment
    1 * LAPARASCOPE GRASPERS, SUCTION AND IRRIGATION