BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL GAMMA KNIFE

    MDR report key: 1627165 · Received March 1, 2010

    Report

    Report Number
    9612186-2010-00002
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Date of Event
    January 22, 2010
    Report Date
    March 1, 2010
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING SO FOLLOW-UP REPORTING TO THIS MDR WILL BE PROVIDED TO FDA UPON COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT WHILE ATTEMPTING TO PERFORM A QA TEST RUN, THE QA TEST TOOL FITTED IN THE MECHANICS FELL OUT ONTO THE TABLE AND LEFT APS Y AXIS FELL BELOW ITS SCALED LIMIT OF 160. SERVICE ENGINEER ARRIVED ON SITE AND CONFIRMED THAT THE SCALE HAD TRAVELLED BEYOND ITS LIMIT OF 160 AND WAS RESTING ON THE ANGLED PORTION OF THE FLEX COVER BUT WAS ABLE TO MANUALLY DRIVE THE Y AXIS TO WITHIN NORMAL RANGE. HOWEVER, BECAUSE OF RELIABILITY, THE MECHANICS COULD NOT BE DETERMINED NOR COULD DETERMINE THE CAUSE OF THE PROBLEM, REPLACEMENT OF MECHANICS AND COMPUTER WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL GAMMA KNIFE SYSTEM, RADIATION THERAPY, RADIONUCLIDE IWB ELEKTA INSTRUMENT AB MODEL 4C NA

    Patients

    Seq Age Sex Outcome Treatment
    1