BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL PTC TEMPERATURE CONTROLLED TISSUE SEALING TECHNOLOGY

    MDR report key: 1246784 · Received November 22, 2008

    Report

    Report Number
    1246784
    Event Type
    Malfunction
    Date Received
    November 22, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 22, 2008
    Manufacturer
    SURGRX, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENSEAL KEPT SAYING REPLACE AND MAKING A STRANGE SOUND. INSTALLED WITH NEW HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL PTC TEMPERATURE CONTROLLED TISSUE SEALING TECHNOLOGY TISSUE SEALING, TEMPERATURE CONTROLLED GEI SURGRX, INC. * F08G09-02

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR