BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPINCE

    MDR report key: 3676680 · Received February 21, 2014

    Report

    Report Number
    3676680
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 21, 2014
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE IMAGING TECHNOLOGIST REPORTED THAT THE DEVICE MALFUNCTIONED DURING A LIVER BIOPSY PROCEDURE. THE END OF THE DEVICE SPLAYED OPEN INSIDE THE PATIENT. A METAL BURR WAS STICKING FROM THE DEVICE WHEN IT WAS REMOVED. THE PHYSICIAN OPERATOR LATER CONFIRMED THAT THERE WAS NOT AN INJURY TO THE PATIENT RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109304 BIOPINCE INSTRUMENT, BIOPSY KNW MEDICAL DEVICE TECHNOLOGIES, INC. * 33472LDM

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR NO OTHER DEVICES WERE RELATED TO THIS DEVICE| FAILURE