BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEREOSTACTIC PROBE

    MDR report key: 1060186 · Received May 19, 2008

    Report

    Report Number
    1060186
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 18, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE BIOPSY NEEDLE WAS IN THE PATIENT AT THE 5:00 POSITION, THE NEEDLE QUIT WORKING. ALL THE CORDS TO THE UNIT WERE CHECKED. REPLACED NEEDLE, AND THE SECOND NEEDLE WAS NOT WORKING PROPERLY. IT WOULD NOT GO FORWARD OR IN REVERSE. UNABLE TO REMOVE NEEDLE FROM BIOPSY GUN. REPLACED BIOPSY GUN WITH A NEW NEEDLE, AND CONTINUED ON WITH THE BIOPSY. PATIENT WAS ASSESSED BY NURSE AFTER THE PROCEDURE.====================== MANUFACTURER RESPONSE FOR STEREOTATIC PROBE, STEREOTACTIC PROBE======================INVESTIGATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEREOSTACTIC PROBE PROBE, STEREOTACTIC, BIOPSY HAW ETHICON ENDO-SURGERY, INC. NA DRJV9Z

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR