BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICAL GUIDANCE PLATFORM

    MDR report key: 1881415 · Received October 19, 2010

    Report

    Report Number
    2916710-2010-00120
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K071360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IDENTIFIED A DESIGN DEFICIENCY DUE TO MECHANICAL CALIBRATION AND TOLERANCES, WHICH CAUSE REFLECTIONS FROM THE GANTRY COVERS SHOWING A POSITIONAL OFFSET. THE PATIENT IS POSITIONED FOR TREATMENT WITH THE GANTRY IN THE HOME (BEAM STRAIGHT DOWN) POSITIONS. GANTRY (COVER) ROTATES TO AN ANGLE SUCH THAT THE REFLECTION OF THE CAMERA'S IR LIGHT IS REFLECTED AT THE SAME ANGLE AS THE REFLECTION OF AN IR MARKER. THIS "COUPLED REFLECTION" CAN RESULT IN A COORDINATE OFFSET, UP TO 2 MM. THIS "COUPLED IR REFLECTION" ONLY HAPPENS AT A SPECIFIC ANGLE THAT IS DEPENDENT ON THE GEOMETRY LINE UP OF THE CAMERA, IR MARKER, AND COVER SLOPE. ANY GREATER OFFSET ERROR IS REPORTED AS A MARKER GEOMETRY FAILURE AND THE SYSTEM REPORTS AN ERROR AND FAILS SAFE. THE USER BELIEVES THE PATIENT IS OFFSET BY 2 MM AND RE-ALIGNS THE PATIENT AND DELIVERS A FIELD IN THE WRONG POSITION. USER MOVES ON TO THE NEXT FIELD, SEES AN OFFSET, AND AGAIN REPOSITIONS THE PATIENT (NOW TO THE CORRECT TX POSITION), AND COMPLETES THE DELIVERY OF ALL REMAINING FIELDS. FRAMELESS SRS LOCALIZATION CLAIMS ACCURACY OF UP TO 1.0 MM AS STATED IN THE CUSTOMER ACCEPTANCE PROCEDURE. IN THIS SCENARIO 2 MM OFFSET AT ISOCENTER AT THE SPECIFIC GANTRY ANGLE WOULD FALL OUTSIDE OF THE REQUIRED PRECISION. CAMERA CALIBRATION/VERIFICATION IS DONE WITH A GANTRY AT 0 AND REFLECTION CAUSES AN INCORRECT OFFSET TO BE DETERMINED. A PRODUCT NOTIFICATION LETTER WILL BE SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    WHEN CALIBRATING THE OGP, THE CUSTOMER PHYSICIST NOTED THAT THEY WOULD SOMETIMES GET A GEOMETRY ERROR. BY STANDING BETWEEN THE CALIBRATION JIG AND THE C-ARM THE GEOMETRY ERROR WENT AWAY AND THEY COULD COMPLETE CALIBRATION. ALL TESTING SHOWED THE DEVICE TO BE IN SPECIFICATION. THE PHYSICIST NOTED THAT THE CAMERA WAS RECENTLY BUMPED 1-4 WEEKS AGO AND THEY RECALIBRATED THE SYSTEM AT THAT TIME. THE PHYSICIST DOES NOT RECALL SEEING THE PROBLEM SINCE THEN. THIS ISSUE OCCURRED DURING DAILY CALIBRATION AND IT WAS SEEN ON THE OGP SCREEN. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED, AS THE USER OBSERVED THIS ISSUE PRIOR TO TREATMENT. NO FURTHER 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 OPS

    Patients

    Seq Age Sex Outcome Treatment
    1