BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOTECH BIOPINCE

    MDR report key: 3136871 · Received May 22, 2013

    Report

    Report Number
    3136871
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO OBTAIN LIVER/HEPATIC LIVER LESION BIOPSY, THE BIOPSY NEEDLE "MISFIRED (LEAVING) A PIECE OF METAL STICKING OUT OF THE NEEDLE. THE NEEDLE IS UNABLE TO FIT IN THE GUIDE NEEDLE AND DOES NOT TAKE A SAMPLE." THE DEVICE WAS UNUSABLE AT THIS POINT AND ANOTHER DEVICE WAS NEEDED TO OBTAIN THE REQUIRED SPECIMEN.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MEDICAL LIVER BIOPSY AND HEPATIC LESION BIOPSY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226401 ANGIOTECH BIOPINCE INSTRUMENT, BIOPSY KNW MEDICAL DEVICE TECHNOLOGIES, INC. * 30312FWD

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR