BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 7687591 · Received July 13, 2018

    Report

    Report Number
    3007774465-2018-00004
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    April 25, 2018
    Report Date
    February 24, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K170355
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE AUTO MODELING IN RAYPHYSICS BEAM COMMISSIONING MAY GENERATE BEAM PROFILE CORRECTION VALUES THAT ARE UNREASONABLE FROM A PHYSICAL POINT OF VIEW FOR RADII POINTS LARGER THAN THE MEASURED CURVES. THEREFORE, SOME MANUAL TUNING IS OFTEN NECESSARY AFTER THE AUTO MODELING. THE EFFECT OF THE VALUES AT RADII LARGER THAN THE MEASURED CURVES, I.E. IN THE CORNERS OF LARGE FIELDS, CANNOT BE VIEWED IN THE BEAM COMMISSIONING WORKSPACE. INSTEAD, THE BEAM 3D WORKSPACE MUST BE USED TO CALCULATE 3D DOSE FOR VALIDATION. THIS ISSUE COULD LEAD TO LOCAL UNDER-DOSAGE, POTENTIALLY LEADING TO IN-EFFECTIVE TREATMENT.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2018-00004 30600 RS CORNER DOSE IN LARGE OR OFF-AXIS FIELDS. USER REPORTED A SIGNIFICANT DOSE HOTSPOT IN THE INFERIOR CORNER OF AN OFF-AXIS FIELD. THE DEVIATION WAS DETECTED DURING TREATMENT PLANNING AND HAD NO IMPACT ON THE PATIENT. THE ROOT CAUSE WAS THAT THE OFF-AXIS BEAM PROFILE CORRECTION IN THE BEAM MODEL HAD VERY HIGH VALUES BEYOND 20 CM. CLINIC HAD FAILED TO VALIDATE THE BEAM MODEL FOR VERY LARGE OR OFF-AXIS FIELDS. THEY RECEIVED ASSISTANCE IN ADJUSTING THE BEAM MODEL. THIS WAS ABNORMAL USE, USING THE SYSTEM CONTRARY TO INSTRUCTIONS. THE RESPONSIBILITY OF THE USER TO VALIDATE THE BEAM MODEL FOR ALL CLINICAL SITUATIONS FOR WHICH IT IS TO BE USED IS CLEARLY STATED IN THE IFU, GIVING FIELD SIZE AND OFF-AXIS FIELDS AS EXPLICIT EXAMPLES OF WHAT NEEDS TO BE INCLUDED. THE CLINIC'S RESPONSIBILITY TO VALIDATE THE BEAM MODEL IS ALSO "COMMON KNOWLEDGE" AND HAS NOT BEEN DISPUTED BY THE CUSTOMERS. HOWEVER, SINCE MORE THAN ONE CLINIC HAS BEEN FOUND TO USE SIMILAR, INCORRECT BEAM MODELS, A FSN HAS BEEN ISSUED (SIMILAR INCIDENT PREVIOUSLY REPORTED IN 3007774465-2018-00002).

    Description of Event or Problem · 1

    USER REPORTED A SIGNIFICANT DOSE HOTSPOT IN THE INFERIOR CORNER OF AN OFF-AXIS FIELD. THE DEVIATION WAS DETECTED DURING TREATMENT PLANNING AND HAD NO IMPACT ON THE PATIENT. THE ROOT CAUSE WAS THAT THE OFF-AXIS BEAM PROFILE CORRECTION IN THE BEAM MODEL HAD VERY HIGH VALUES BEYOND 20 CM. CLINIC HAD FAILED TO VALIDATE THE BEAM MODEL FOR VERY LARGE OR OFF-AXIS FIELDS. THEY RECEIVED ASSISTANCE IN ADJUSTING THE BEAM MODEL. THIS WAS ABNORMAL USE, USING THE SYSTEM CONTRARY TO INSTRUCTIONS. THE RESPONSIBILITY OF THE USER TO VALIDATE THE BEAM MODEL FOR ALL CLINICAL SITUATIONS FOR WHICH IT IS TO BE USED IS CLEARLY STATED IN THE IFU, GIVING FIELD SIZE AND OFF-AXIS FIELDS AS EXPLICIT EXAMPLES OF WHAT NEEDS TO BE INCLUDED. THE CLINIC'S RESPONSIBILITY TO VALIDATE THE BEAM MODEL IS ALSO "COMMON KNOWLEDGE" AND HAS NOT BEEN DISPUTED BY THE CUSTOMERS. HOWEVER, SINCE MORE THAN ONE CLINIC HAS BEEN FOUND TO USE SIMILAR, INCORRECT BEAM MODELS, A FSN HAS BEEN ISSUED (SIMILAR INCIDENT PREVIOUSLY REPORTED IN 3007774465-2018-00002).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528070 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other