BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED GYNECOLOGICAL APPLICATOR VENEZIA

    MDR report key: 10689399 · Received October 16, 2020

    Report

    Report Number
    10689399
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    March 5, 2020
    Report Date
    October 2, 2020
    Manufacturer
    ELEKTA LIMITED
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT FINISHED 5 HIGH DOSE RATE BRACHYTHERAPY. UPON REMOVAL OF THE VENEZIA BRACHYTHERAPY APPLICATOR, THE LUNAR OVOID BROKE AT THE "CLICK MECHANISM" AFTER BEING REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157163 ADVANCED GYNECOLOGICAL APPLICATOR VENEZIA SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED JAQ ELEKTA LIMITED 1000083191

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA