BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16501825 · Received March 8, 2023

    Report

    Report Number
    3007774465-2023-00028
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    March 2, 2018
    Report Date
    March 19, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K180379
    Removal / Correction Number
    RES 80252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. FOR MACHINES WITH FIXED JAWS (ELEKTA BM AND VERO) OR MACHINES WITH THE MLC CLOSER TO THE SOURCE THAN BOTH X- AND Y-JAWS (ELEKTA SYNERGY WITH MLCI/MLCI2), THE DOSE CALCULATION ACCURACY MAY IN SOME SITUATIONS BE LESS THAN EXPECTED. THE ERROR IS THAT LEAF PAIRS THAT ARE CLOSED INSIDE THE FIELD WITH A NON-ZERO MINIMUM TIP GAP ARE CONSIDERED OPEN WHEN COMPUTING THE FIELD MEASURE (EQUIVALENT SQUARE) FOR OUTPUT FACTOR CORRECTION (OFC). THE ERROR CAN MANIFEST IN BC FOR ELEKTA SYNERGY MLCI/MLCI2 WHEN USING "MLC ONLY" DOSE CURVES, POTENTIALLY LEADING TO A BEAM MODEL WITH INCORRECT OFC (SCENARIO A). THE ERROR MAY ALSO MANIFEST IN RAYSTATION MAIN DOSE CALCULATION FOR ELEKTA SYNERGY MLCI/MLCI2, ELEKTA BM AND VERO, WHERE THE BUG WOULD LEAD TO USING OFC FOR AN INCORRECT FIELD SIZE (SCENARIO B). WHEN ATTEMPTING TO CREATE A WORST-CASE SCENARIO WITH A TYPICAL BEAM MODEL, THE COMPUTED DOSES ARE UP TO ~2% HIGHER THAN FOR A CORRECTLY CALCULATED FIELD MEASURE. THIS IS NOT EXPECTED TO HAVE ANY HEALTH EFFECTS. HOWEVER, LARGER DEVIATIONS CANNOT BE RULED OUT COMPLETELY. LOCAL MARGINAL OR MODERATE OVER- OR UNDERDOSAGE COULD POTENTIALLY OCCUR. THE EFFECT ON THE PATIENT WOULD DEPEND ON THE PARTICULAR PLAN SETUP AND PATIENT ANATOMY.

    Description of Event or Problem · 0

    NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. AN ISSUE WITH THE PHOTON COLLAPSED CONE DOSE CALCULATION HAS BEEN FOUND BY MANUFACTURER. FOR MACHINES WITH FIXED JAWS (ELEKTA BM AND VERO) OR MACHINES WITH THE MLC CLOSER TO THE SOURCE THAN BOTH X- AND Y-JAWS (ELEKTA SYNERGY WITH MLCI/MLCI2), THE DOSE CALCULATION ACCURACY MAY IN SOME SITUATIONS BE LESS THAN EXPECTED. THE ERROR IS THAT LEAF PAIRS THAT ARE CLOSED INSIDE THE FIELD WITH A NON-ZERO MINIMUM TIP GAP ARE CONSIDERED OPEN WHEN COMPUTING THE FIELD MEASURE (EQUIVALENT SQUARE) FOR OUTPUT FACTOR CORRECTION (OFC). THE ERROR CAN MANIFEST IN BC FOR ELEKTA SYNERGY MLCI/MLCI2 WHEN USING "MLC ONLY" DOSE CURVES, POTENTIALLY LEADING TO A BEAM MODEL WITH INCORRECT OFC (SCENARIO A). THE ERROR MAY ALSO MANIFEST IN RAYSTATION MAIN DOSE CALCULATION FOR ELEKTA SYNERGY MLCI/MLCI2, ELEKTA BM AND VERO, WHERE THE BUG WOULD LEAD TO USING OFC FOR AN INCORRECT FIELD SIZE (SCENARIO B).

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2023-00028 28672 RS FIELD MEASURE ERROR FOR ELEKTA MACHINES. NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. AN ISSUE WITH THE PHOTON COLLAPSED CONE DOSE CALCULATION HAS BEEN FOUND BY MANUFACTURER. AN ISSUE WAS FOUND WITH THE PHOTON COLLAPSED CONE DOSE CALCULATION IN RAYSTATION 6 (RAYPLAN 2) AND RAYSTATION 7 (RAYPLAN 7). FOR MACHINES WITH FIXED JAWS (E.G., ELEKTA BM AND VERO) AND MACHINES WITH THE MLC CLOSER TO THE SOURCE THAN BOTH X- AND Y-JAWS (E.G., ELEKTA SYNERGY WITH MLCI/MLCI2), THE DOSE CALCULATION ACCURACY MAY IN SOME SITUATIONS BE LESS THAN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121461 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 6 (RAYPLAN 2) AND RAYSTATION 7 (RAYPLAN 7)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown