BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2152973 · Received June 28, 2011

    Report

    Report Number
    3003793371-2011-00025
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS FINLAND OY
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A KNOWN ISSUE WHICH HAS PREVIOUSLY BEEN INVESTIGATED AND REPORTED. THE INVESTIGATION DETERMINED THAT THE ADDITION OF COUCH STRUCTURES TO A 4D AVERAGED CT DATA SET BEFORE ANATOMICAL STRUCTURES HAVE BEEN MERGED, CAN LEAD TO DISPLACEMENT OF THE CONTOURED STRUCTURES WITHIN THE CT DATA. THE CONTOURED STRUCTURES CAN BE DISPLACED IN ALL DIRECTIONS DEPENDING UPON THE POSITION OF THE BODY TO THE COUCH STRUCTURE. THE INCORRECT TARGET POSITION AND VOLUMES OF INTEREST LOCATIONS CAN THEN BE USED FOR PLANNING AND TREATMENT. ROOT CAUSE: SOFTWARE DEFECT. CORRECTIVE ACTION: A DISCREPANCY REPORT (DR) HAS BEEN CREATED TO ADDRESS THIS ISSUE IN THE AFFECTED INSTALL BASE. AN ISSUE REVIEW (IR) HAS BEEN SUBMITTED AND ANY ADDITIONAL CORRECTIVE ACTIONS WILL BE HANDLED IN THE VARIAN CAPA PROCESS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY AS A RESULT OF THIS ISSUE. NO FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE 4D MERGED STRUCTURES DISPLACED DUE TO ENLARGED IMAGES. CUSTOMER CALLED TO REPORT THAT THEY ARE SEEING SHIFTED STRUCTURES WHEN USING 4D STRUCTURE MERGE TOOL IN CONTOURING. CUSTOMER CONTOURED PTV ON MULTIPLE BREATHING PHASE IMAGE SETS AND USED 4D STRUCTURE MERGE TO COMBINE THEM. CUSTOMER STATES THAT THE TRIGGER FOR THIS SHIFT IS WHEN THE PLANNING IMAGE SET LENGTH (SUP/INF) IS LONGER THAN THE BREATHING PHASE IMAGE SETS. WHEN THE 4D MERGED STRUCTURE IS APPLIED, THE PLANNING IMAGE IS SHIFTED DOWN THE EXACT DIFFERENCE, AS THE DIFFERENCE BETWEEN THE INF BORDER OF THE BREATHING PHASE AND PLANNING CTS. THERE WAS NO REPORT OF SERIOUS INJURY OR MISADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE SYSTEM, PLANNING, RADIATION THERAPY TREAT MUJ VARIAN MEDICAL SYSTEMS FINLAND OY H48

    Patients

    Seq Age Sex Outcome Treatment
    1