BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFENDO

    MDR report key: 3983119 · Received July 11, 2014

    Report

    Report Number
    3983119
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDIVATORS INC
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RN NOTED SPRAYING ON SIDE OF FACE WHILE FORCEPS THROUGH DEFENDO; NO MUCOSAL CONTACT. PROCEDURE ENDED UNREMARKABLY AND SCOPE TESTED WITHOUT FORCEPS IN BIOPSY PORT: A FINE STREAM WAS NOTED EXTENDING STRAIGHT OUT FROM THE ORIFICE OF THE DEFENDO APPROXIMATELY 5 FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408110 DEFENDO ENDOSCOPE CHANNEL ACCESSORY FEB MEDIVATORS INC 100303 725593

    Patients

    Seq Age Sex Outcome Treatment
    1 *