BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 2D

    MDR report key: 2012256 · Received February 24, 2011

    Report

    Report Number
    1220984-2011-00001
    Event Type
    Other
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 24, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011 AN HOLOGIC FIELD ENGINEER WENT TO THE SITE TO DETERMINE THE CAUSE OF THE INCIDENT. THE FIELD ENGINEER WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE MAGNIFICATION STAND WAS OPERATING TO HOLOGIC SPECIFICATIONS WHEN SECURELY ATTACHED TO THE SYSTEM. THE FIELD ENGINEER REPLACED THE MAGNIFICATION STAND AND RETURNED THE ONE IN QUESTION TO THE MFG FACILITY FOR FURTHER EVAL. THE MAGNIFICATION STAND WAS RECEIVED AT THE MFG FACILITY AND WAS EVALUATED BY A MFG ENGINEER. THE MFG ENGINEER NOTED A CRACK IN THE CARBON FIBER ON THE RIGHT SIDE OF THE FRAME, AS WELL AS MINOR SCRATCHES ON THE FRAME. IT IS UNK IF THE DAMAGE WAS CAUSED PRIOR TO OR WHEN IT FELL FROM THE SYSTEM. OTHER THAN THE SLIGHT DAMAGE OBSERVED, THE MAGNIFICATION STAND MET ALL HOLOGIC DIMENSIONAL SPECIFICATIONS. A FUNCTIONAL REVIEW INCLUDED ATTACHING THE MAGNIFICATION STAND TO A (B)(6). THIS TEST REVEALED THE VISIBLE DAMAGE DID NOT PREVENT THE NORMAL OPERATION OF THE MAGNIFICATION STAND. IT COULD NOT BE DETERMINED WHAT MADE THE MAGNIFICATION STAND FALL FROM THE MACHINE.

    Description of Event or Problem · 1

    DURING A MAMMOGRAPHY PROCEDURE THE TECHNOLOGIST TURNED THE SYS C-ARM TO A 90 DEGREE LATERAL ANGLE. WHILE POSITIONING THE PT THE MAGNIFICATION STAND FELL FROM THE SYSTEM AND LANDED ON THE TECHNOLOGIST'S FOOT. THIS CAUSED SORENESS TO THE TECHNOLOGIST'S FOOT SIMILAR TO A SPRAIN, BUT SHE IS WALKING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 2D MAMMOGRAPHY SYSTEM IZH HOLOGIC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other