BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEROGUIDE PRONE BREAST BIOPSY SYSTEM

    MDR report key: 19166 · Received January 26, 1995

    Report

    Report Number
    MW1004874
    Event Type
    Malfunction
    Date Received
    January 26, 1995
    Date of Event
    January 9, 1995
    Report Date
    January 13, 1995
    Manufacturer
    LORAD MEDICAL SYSTEMS, INC.
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAVING STEREOTACTIC BREAST BIOPSY. BIOPSY NEEDLE PLACED IN BREAST. FIRST X-RAY TAKEN AND C-ARM ROTATED TO TAKE VIEW. EQUIPMENT FAILED. TROUBLE-SHOOTING DONE WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEROGUIDE PRONE BREAST BIOPSY SYSTEM BREAST BIOPSY UNIT IZH LORAD MEDICAL SYSTEMS, INC. 3000-A-0935

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR