BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO PINCE

    MDR report key: 661892 · Received November 29, 2005

    Report

    Report Number
    MW1037637
    Event Type
    Malfunction
    Date Received
    November 29, 2005
    Date of Event
    November 29, 2005
    Report Date
    November 29, 2005
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LIVER BIOPSY THE 18 GAUGE BIOPINCE FULL CORE BIOPSY INSTRUMENT DID NOT RETRACT PROPERLY. PT SCANNED TO BE CERTAIN NO METAL SHAVINGS OR EXCESS BLEEDING PRESENT. NO APPARENT INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO PINCE FULL CORE BIOPSY INSTRUMENT KNW MEDICAL DEVICE TECHNOLOGIES, INC. REF: # 360-1080-01 51531

    Patients

    Seq Age Sex Outcome Treatment
    1 *