BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTICAL GUIDANCE PLATFORM

    MDR report key: 1271517 · Received December 22, 2008

    Report

    Report Number
    2916710-2007-00011
    Event Type
    Other
    Date Received
    December 22, 2008
    Date of Event
    February 20, 2007
    Report Date
    February 20, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K071360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FLOORSTAND HAS LIMIT SWITCHES, WHICH ARE DESIGNED TO DISABLE GANTRY ROTATION OF THE LINAC FOR CERTAIN BEAM ANGLES WHERE THERE IS A POTENTIAL FOR COLLISION BETWEEN THE GANTRY HEAD AND THE FLOORSTAND AS THE GANTRY MOVES TOWARD THE FLOOR. THESE SWITCHES WERE DESIGNED TO BE COMPATIBLE WITH THE ELEKTA ACCELERATORS (SL 75/5 AND SL 20) AND ARE COMPATIBLE WITH THE VARIAN 2100C, BUT ARE INADEQUATE FOR USE ON THE CLINAC 6-100 AND 600C MODELS - WHICH REQUIRE A BROADER RANGE OF EXCLUSION ANGLES THAT CAN BE SET ON THE FLOORSTAND, AND, POSSIBLY, OTHER THIRD PARTY LINACS AS WELL. NO ADVERSE EVENT HAS BEEN REPORTED, AND THE ISSUE IS NOT DUE TO MALFUNCTION, BUT RATHER USE ON LINACS FOR WHICH THE DEVICE WAS NOT VALIDATED. TWO END USER COMPLAINTS WERE RECEIVED DURING 2007. A PRODUCT NOTIFICATION LETTER WILL BE DISTRIBUTED TO ALL ACTIVE USERS WHO HAVE THE FLOORSTAND INSTALLED WITH A CLINAC 600C OR OTHER NON-VALIDATED MODEL, WITH A DESCRIPTION OF THE PROBLEM AND USER CORRECTIVE ACTION STEPS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF (B) (4). NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POTENTIAL FOR THE GANTRY TO BE DRIVEN INTO THE FLOOR STAND. THE GANTRY LIMIT SWITCHES IN THE FLOOR STAND ARE DESIGNED FOR AN ELEKTA SL75 WITH MOTION INTERRUPTS FITTED FOR 130 DEGREES +/-; WHEN INSTALLING THE LOW ENERGY MACHINES, IT NEEDS TO INTERRUPT AT +/-120 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICAL GUIDANCE PLATFORM ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS HZ5

    Patients

    Seq Age Sex Outcome Treatment
    1