BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEALTRIO

    MDR report key: 2111937 · Received May 26, 2011

    Report

    Report Number
    2111937
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US

    Narratives

    Description of Event or Problem · 1

    AFTER REMOVED FROM PACKAGING, THE ENSEAL TRIO DEVICE FAILED WHEN HANDLED BY THE PHYSICIAN. PER THE OR NURSE, THE HANDPIECE "FELL APART". THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER ENSEAL TRIO WAS OPENED AND USED FOR THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEALTRIO TEMPERATURE CONTROLLED TISSUE SEALING DEVICE GEI ETHICON ENDO-SURGERY, INC. ETRIO335H H43G5M

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR