BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE

    MDR report key: 5754556 · Received June 24, 2016

    Report

    Report Number
    MW5063095
    Event Type
    Other
    Date Received
    June 24, 2016
    Date of Event
    May 17, 2016
    Manufacturer
    ERBE USA, INC.
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NO COAG OR CUT BURN NOTED WHEN PEDAL ACTIVATED. NO WARNING MESSAGE NOTED, GREEN LIGHTS NOTED. CASE CANCELED, PT WILL HAVE TO RETURN FOR POLYP REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403364 ERBE ERBE NESSY PLATE GEI ERBE USA, INC. 02441

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR