BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOTECH

    MDR report key: 879480 · Received July 10, 2007

    Report

    Report Number
    MW5002991
    Event Type
    Malfunction
    Date Received
    July 10, 2007
    Date of Event
    July 10, 2007
    Report Date
    July 10, 2007
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I WORK AT HOSPITAL AS A CT TECH. WE USE BIOPINCE FULL CORE BIOPSY INSTRUMENTS FOR MANY BIOPSIES. RECENTLY, THERE HAS BEEN A NUMBER OF WHAT APPEAR TO BE DEFECTIVE INSTRUMENTS BEING SHIPPED. TODAY WE PERFORMED TWO LIVER BIOPSIES WHERE AFTER THE INITIAL CORE WAS TAKEN, THE BIOPSY GUN FAILED AND HAD TO BE REPLACED. THE SECOND BIOPSY REQUIRED THE USE OF THREE GUNS BECAUSE THE FIRST TWO WERE DEFECTIVE. THE GUNS ARE MFG BY MEDICAL DEVICE TECHNOLOGIES INC. THE PHONE NUMBER FOR THE COMPANY IS 352-338-0440. THE DEVICE IS THE 18 GA BY 10 CM BIOPSY GUN. THE LOT NUMBER IS 71721H68. AGAIN THIS IS NOT THE FIRST TIME THIS HAS HAPPENED RECENTLY, AND WE HAVE CONTACTED THE VENDOR IN THE PAST TO TRY TO RECTIFY THIS WITHOUT ANY APPARENT SUCCESS. DATES OF USE: 2005 - 2007. DIAGNOSIS: PERCUTANEOUS C.T. GUIDED BIOPSIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOTECH BIOPINCE FULL CORE BIOPSY INSTRUMENT KNW MEDICAL DEVICE TECHNOLOGIES 71721H68

    Patients

    Seq Age Sex Outcome Treatment
    1 YR