BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA NAVIGATION PROBE 2.0

    MDR report key: 7984036 · Received October 19, 2018

    Report

    Report Number
    7984036
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    August 13, 2018
    Report Date
    October 4, 2018
    Manufacturer
    DILON TECHNOLOGIES, INC.
    Product Code
    IZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE TIGHTENING SCREW ON THE BACK OF THE UNIT, THE MACHINE CAUGHT FIRE. THE FIRE WAS EXTINGUISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824962 GAMMA NAVIGATION PROBE 2.0 PROBE, UNTAKE, NUCLEAR IZD DILON TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1