BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAXIAL ACHIEVE- AUTOMATIC BIOPSY SYSTEM

    MDR report key: 1813615 · Received July 28, 2010

    Report

    Report Number
    1813615
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 17, 2010
    Report Date
    July 23, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE COAXIAL ACHIEVE BIOPSY NEEDLE WAS FIRED TWICE CORRECTLY. THEN IT WOULD NOT FIRE AGAIN. ANOTHER ACHIEVE BIOPSY NEEDLE WAS GIVEN TO THE PHYSICIAN WHO WAS THEN ABLE TO CONTINUE COLLECTING THE BIOPSY TISSUE SAMPLES. THE PROCEDURE WAS FINISHED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAXIAL ACHIEVE- AUTOMATIC BIOPSY SYSTEM KIT, NEEDLE, COAXIAL ACHIEVE, SYSTEM FCG CARDINAL HEALTH N/A D10020204

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR