BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTEST

    MDR report key: 2615502 · Received June 7, 2012

    Report

    Report Number
    2240869-2012-00044
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Date of Event
    May 11, 2012
    Report Date
    June 5, 2012
    Manufacturer
    SIEMENS AG
    Product Code
    IZH
    PMA / PMN Number
    K042095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS LOCAL SERVICE ENGINEER, (B)(4), WAS DISPATCHED TO THE SITE TO CHECK THE UNIT. THE ENGINEER FOUND THAT THE NEEDLE CONFIGURATION REQUIRED VERIFICATION AND RECALIBRATION. THE ENGINEER RELOADED ALL VALUES AND COMPLETED TARGET CALIBRATION. THE UNIT WAS SUCCESSFULLY TESTED WITH 8 AND 11 GAUGE NEEDLES. THE SYSTEM WAS BROUGHT BACK TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A BREAST BIOPSY PROCEDURE ON THE MAMMOTEST SYSTEM, THE NEEDLE WENT THROUGH THE PATIENT'S BREAST, SLIGHTLY EXITING ON THE OPPOSITE SIDE OF THE BREAST. THE CUSTOMER DESCRIBED IT AS A FLESH WOUND, WHICH WAS TREATED WITH GLUE AND A PROTECTIVE BANDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTEST SYSTEM, X-RAY, MAMMOGRAPHIC IZH SIEMENS AG 10144185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention