BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL GAMMAPLAN, KULA

    MDR report key: 34195 · Received July 1, 1996

    Report

    Report Number
    1037831-1996-00005
    Event Type
    Malfunction
    Date Received
    July 1, 1996
    Report Date
    July 1, 1996
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CO HAS INTERNALLY DISCOVERED A CALCULATION ERROR IN THE DOSE PLANNING SYSTEM AND ITS PREDECESSOR. NO COMPLAINTS CONCERNING THIS MATTER HAVE BEEN RECEIVED FROM ANY OF THE SYSTEM USERS. THE ERROR MAY, UNDER UNUSUAL CIRCUMSTANCES, RESULT IN MISCALCULATION OF THE DISTANCE FROM THE SKULL BOUNDARY TO THE TARGET. THEORETICALLY, THIS COULD RESULT IN A LOWER DOSE THAN PRESCRIBED TO THE TARGET. THIS COULD HAPPEN ONLY FOR SUPERFICIAL TARGETS, USING THE DEVICE CLOSE TO ITS VERY LIMITS. PRELIMINARY INVESTIGATIONS SHOW THAT THE UNDERDOSE IS WITHIN NORMAL ACCEPTED CLINICAL FLUCTUATIONS. INVESTIGATION WILL CONTINUE AND CO WILL INFORM FDA IF ANY SIGNIFICANT CHANGE IN THE PRELIMINARY CONCLUSIONS ARE MADE. GAMMA KNIFE USERS HAVE BEEN INFORMED AND THE SOFTWARE IS BEING UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL GAMMAPLAN, KULA RADIATION THERAPY IWB ELEKTA INSTRUMENT AB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other