BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D

    MDR report key: 5873705 · Received August 12, 2016

    Report

    Report Number
    1220894-2016-00019
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 28, 2016
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OTE
    UDI-DI
    15420045500013
    PMA / PMN Number
    PO80003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOGS WERE READ AND AN INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THIS MDR IS A RESUBMIT PER REQUEST OF (B)(6) WHICH WAS RECEIVED BY HOLOGIC, INC. ON (B)(6) 2020. DURING A STEREO BIOPSY THE TECHNOLOGIST CONFIRMED THE COORDINATES FOR THE NEEDLE POSITION, THEN PRESSED THE MOTOR ENABLE BUTTON TO MOVE THE NEEDLE TO THE TARGET, SHE SAID THE UNIT BEEPED VERY QUICKLY SO SHE RELEASED THE MOTOR ENABLE BUTTONS. THE TECHNOLOGIST THEN NUMBED THE PATIENT BREAST AND MADE AN INCISION. NEXT SHE WENT TO MANUALLY DIAL IN THE NEEDLE AND NOTICED IT WAS IN THE INCORRECT POSITION. THE TECHNOLOGIST THEN RETARGETED AND HELD THE MOTOR ENABLE BUTTON LONGER AND THE NEEDLE WENT TO THE CORRECT POSITION SO SHE THEN MADE A SECOND INCISION AND CONTINUED TO DO A SUCCESSFUL BIOPSY. A FE REVIEWED THE DEVICE LOGS AND DETERMINED IT WAS POSSIBLE USER ERROR OR SWITCHES GOING BAD. WHEN THE CUSTOMER RETARGETED AND RESET THE COORDINATES, THE MACHINE WORKED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526154 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D MAMMOGRAPHY SYSTEM OTE HOLOGIC, INC. SDM-05000-3D3 N/A 15420045500013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown