BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARIS VISION TREATMENT EVI

    MDR report key: 747450 · Received October 31, 2005

    Report

    Report Number
    2914292-2005-00008
    Event Type
    Other
    Date Received
    October 31, 2005
    Date of Event
    May 26, 2005
    Report Date
    October 30, 2005
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION PERFORMED BY VARIAN IT WAS DISCOVERED THAT IF A SYMMETRIC FIELD IS MODED UP WHEN THE LINAC ACTUAL POSITIONS ARE ASYMMETRIC, AND THE LINAC X1 OR Y1 JAW VALUE IS 1/2 OF THE PLAN SYMMETRIC VALUE, THEN THE X2 OR Y2 JAW VALUE CAN BE OUT OF POSITION AND VARIS VISION WILL NOT INHIBIT TREATMENT. IF THE OPERATOR OVERLOOKS THE FIELD SIZE DISCREPANCY, THE PT COULD BE TREATED WITH THE WRONG FIELD. UPON INITIAL REVIEW OF THIS ISSUE ON JUNE 14TH, 2005, THE HAZARD ANALYSIS TEAM INDICATED THAT A SERIOUS INJURY WAS NOT LIKELY. HOWEVER, UPON FURTHER REVIEW ON JUNE 21, 2005, IT WAS DETERMINED THAT THIS ISSUE COULD LIKELY RESULT IN A SERIOUS INJURY TO A CRITICAL STRUCTURE IF IT WERE TO RECCUR. A PRODUCT NOTIFICATION LETTER WAS DISTRIBUTED ON SEPTEMBER 20, 2005 TO ALL RELEVANT CUSTOMERS WARNING THEM OF THIS ISSUE. A CORRECTION NOTICE WAS SENT TO THE LOCAL RECALL COORDINATOR ON OCTOBER 4, 2005. A FIX FOR THIS PROBLEM HAS BEEN CREATED AND WILL BE APPLIED TO THE CUSTOMER SYSTEMS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE FOLLOWING EVENT: THE PLANNED FIELD SIZE WAS 20X20. THE Y ACTUAL VALUE WAS 20, BUT THE X ACTUAL WAS 11. VARIS DID NOT SHOW AN ORANGE BOX ON THE X SIZE TO SHOW IT WAS OUT OF TOLERANCE. THE "RADIOGS" USED ASU AND THE LINAC WENT TO THE PLANNED POSITION. THE CUSTOMER NOTICED THE DISCREPANCY, THEREFORE THERE WAS NOT A MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIS VISION TREATMENT EVI ACCELERATOR, LINEAR, MEDICAL-SOFTWARE IYE VARIAN MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other