BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTEST

    MDR report key: 515433 · Received January 23, 2004

    Report

    Report Number
    1418957-2004-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2004
    Date of Event
    January 7, 2004
    Report Date
    January 22, 2004
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    MIJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TECHNOLOGIST ADVANCED NEEDLE INTO PT'S BREAST AND THEN NOTICED THE AUTOGUIDE WAS NOT LATCHED SECURELY SO SHE LATCHED IT. THE DOCTOR STATED HE WANTED TO CHECK THE MOUNTING AND INTENTIONALLY STRUCK THE REAR OF THE AUTOGUIDE ON ITS HANDLE AREA IN A FORWARD DIRECTION (TOWARD THE PT'S BREAST) WITH HIS LEFT ELBOW. THE AUTOGUIDE UNLATCHED AND TRAVELED FORWARD AND THE NEEDLE WENT FURTHER INTO THE BREAST. THE PT WAS EXAMINED FOR POSSIBLE NEEDLE PENETRATION TO THE POSTERIOR SIDE BUT NO SUCH PENETRATION WAS FOUND. PT WAS GIVEN NORMAL POST BIOPSY CARE AND SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTEST BREAST BIOPSY SYSTEM MIJ FISCHER IMAGING CORP. 85500G-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other