BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D

    MDR report key: 8391020 · Received March 5, 2019

    Report

    Report Number
    1220984-2019-00017
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 13, 2019
    Report Date
    February 13, 2019
    Manufacturer
    HOLOGIC, INC
    Product Code
    OTE
    PMA / PMN Number
    P080003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    IT WAS DETERMINED THAT WHEN AN MLO VIEW IS IN THE PROCEDURE THE PADDLE RAISES TO PERFORM SHIFT. THE TECHNOLOGIST IS REMOVING ALL VIEWS FROM THE LOCALIZATION PROCEDURE. THEY WILL ADD VIEWS AS NEEDED WHILE DOING THE NEEDLE LOCALIZATION.

    Additional Manufacturer Narrative · 1

    AS OF TODAY THIS INVESTIGATION IS STILL IN-PROGRESS AND A FOLLOW-UP WILL BE FILED AS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE THE NEEDLE LOCALIZATION PADDLE RELEASED AUTOMATICALLY WHEN IN MANUAL MODE. NO INJURY WAS REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185116 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D MAMMOGRAPHY SYSTEM OTE HOLOGIC, INC SDA-SYS-3000-3D

    Patients

    Seq Age Sex Outcome Treatment
    1