BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERV BIOPINCE FULL CORE BIOPSY INSTRUMENT

    MDR report key: 1053186 · Received May 13, 2008

    Report

    Report Number
    1053186
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ANGIOTECH
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOPSY GUN DID NOT WORK PROPERLY. WAS EXTREMELY DIFFICULT TO LOAD AND WAS NOT FIRING CORRECTLY, GIVING INADEQUATE SAMPLES. AS A RESULT, PATIENT MAY HAVE HAD EXTRA BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERV BIOPINCE FULL CORE BIOPSY INSTRUMENT INSTRUMENT, BIOPSY KNW ANGIOTECH * 80451LHS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR