BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICAL GUIDANCE PLATFORM

    MDR report key: 1876605 · Received October 13, 2010

    Report

    Report Number
    2916710-2010-00116
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K071360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL INTERFACE (INTERFACE MOUNT ON THE CLINAC) / CONICAL COLLIMATOR MOUNT DAMAGE LEADS TO INCORRECT ISOCENTER ALIGNMENT. INCORRECT ISOCENTER ALIGNMENT MAY GO UNDETECTED IF THE USER DOES NOT PERFORM WINSTON-LUTZ TEST PRIOR TO EVERY SRS TREATMENT. NO MISADMINISTRATION OCCURRED IN THIS CASE. HOWEVER, THE MAGNITUDE OF ERROR IS IN RANGE OF MAXIMUM 2-3 MM OFF TARGET TREATMENT. THIS WOULD RESULT IN UNINTENDED HIGH DOSE TO NORMAL TISSUE AND CRITICAL STRUCTURES. A PRODUCT NOTIFICATION LETTER WILL BE SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. FURTHER ACTIONS WILL BE ADDRESSED IN VARIAN'S CAPA PROCESS. NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT CERTAIN COUCH ANGLES, THE OGP SYSTEM LOSES SIGNAL, THE SCREEN FLICKERS AND THEY GET A GEOMETRY ERROR. SHE SAID THEY ARE ABLE TO CONTINUE TREATING BECAUSE THE SYSTEM REACQUIRES THE SIGNAL. SHE SAID IT OCCURS JUST A CERTAIN COUCH ANGLES. THE PROBLEM OCCURS WHEN THE COUCH IS AT CERTAIN ANGLES WHEN THEY ARE TRYING TO ACQUIRE A SIGNAL ATG OGP. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED AND NO PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICAL GUIDANCE PLATFORM ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS HZ1-OPS

    Patients

    Seq Age Sex Outcome Treatment
    1