BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEREO-GUIDE

    MDR report key: 1706966 · Received May 26, 2010

    Report

    Report Number
    1220984-2010-00002
    Event Type
    Malfunction
    Date Received
    May 26, 2010
    Report Date
    May 21, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZH
    PMA / PMN Number
    K030666
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMMAND KEYBOARD WAS OPENED AND IT WAS DETERMINED THAT BLOOD WAS PRESENT INSIDE THE KEYBOARD. THE BLOOD CREATED A SHORT IN THE PC BOARD CAUSING UNINTENDED MOVEMENT OF THE C-ARM. THE SYSTEM HAS A LOCKOUT SAFETY KEYSWITCH TO BE USED DURING ALL BIOPSY PROCEDURES TO PREVENT INADVERTENT MOVEMENT OF THE C-ARM, PER THE OPERATOR MANUAL. USE OF THE KEYSWITCH BY THE OPERATOR IS UNCONFIRMED. THE KEYBOARD CONTACTS WERE CLEANED AND THE SYSTEM WAS RETURNED TO USE.

    Description of Event or Problem · 1

    PT WAS PRONE ON THE BIOPSY TABLE. THE BIOPSY NEEDLE WAS REMOVED FROM HER BREAST AND BLEEDING WAS PRESENT. BLOOD DRIPPED ON THE MOVEMENT CONTROL KEYBOARD. THE C-ARM STARTED MOVING DOWNWARD WHILE THE BREAST WAS UNDER COMPRESSION. THE UNINTENDED MOVEMENT CAUSED SOME BREAST PAIN, BUT THERE WAS NO SERIOUS INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEREO-GUIDE STEREOTACTIC BREAST BIOPSY SYSTEM IZH HOLOGIC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1