BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI SCOUT

    MDR report key: 12149060 · Received July 12, 2021

    Report

    Report Number
    12149060
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    June 18, 2021
    Report Date
    July 6, 2021
    Manufacturer
    CIANNA MEDICAL, INC / MERIT MEDICAL SYSTEMS
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FIRST REFLECTOR THAT WAS INSERTED INTO THE PATIENT'S BREAST TISSUE ONLY GAVE "1 BEEP" WHEN THE SOUND SHOULD BE CONTINUAL BEEPING. THEREFORE, A SECOND REFLECTOR WAS PLACED AND TESTED. THE SECOND REFLECTOR GAVE THE CONTINUAL BEEPS. THE MACHINE IS TESTED PRIOR TO THE EXAM, BUT THE INDIVIDUAL REFLECTORS CANNOT BE TESTED. PER THE MAMMOGRAPHY TECHNICIAN, THE SALES REP FOR THE MANUFACTURER WAS NOTIFIED VIA EMAIL OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045947 SAVI SCOUT MARKER, RADIOGRAPHIC, IMPLANTABLE NEU CIANNA MEDICAL, INC / MERIT MEDICAL SYSTEMS SSR10-01 ML04906

    Patients

    Seq Age Sex Outcome Treatment
    1