BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO DISPOSABLE TISSUE SEALING DEVICE

    MDR report key: 8540360 · Received April 22, 2019

    Report

    Report Number
    MW5086044
    Event Type
    Malfunction
    Date Received
    April 22, 2019
    Date of Event
    April 17, 2019
    Report Date
    April 18, 2019
    Manufacturer
    ETHICON ENDO-SURGERY LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENSEAL HAND PIECE NOT SEALING TISSUE CORRECTLY PER MD. NEW DEVICE OBTAINED WHICH WORKED CORRECTLY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331585 ENSEAL TRIO DISPOSABLE TISSUE SEALING DEVICE ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI ETHICON ENDO-SURGERY LLC T92F82

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR