BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 6529323 · Received April 28, 2017

    Report

    Report Number
    3007774465-2017-00002
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    February 16, 2017
    Report Date
    April 4, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K160093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RAYSTATION WEDGE FACTORS ARE DEFINED AS WEDGE OUTPUT DIVIDED BY OUTPUT FOR THE SAME SIZE OPEN FIELD. THE WEDGE FACTOR DEFINITION IS CLEARLY STATED IN THE LABELING (REF. MANUAL 1.6.2) AND IS ALSO INCLUDED IN PHYSICS TRAINING.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL MDR: 3007774465-2017-00002 (B)(6) WEDGE FACTORS NORMALIZED TO 10X10 FIELD. A VETERINARY CLINIC USED A CONTRACT SERVICE TO HELP THEM WITH BEAM MODELING. THE USER CREATED THE BEAM MODEL USING WEDGE FACTORS CALCULATED AS WEDGE FIELD NORMALIZED TO THE 10X10 OPEN FIELD. HOWEVER, WEDGE FACTORS TO BE ENTERED IN THE RAYSTATION PHYSICS MODULE ARE DEFINED AS WEDGE OUTPUT DIVIDED BY OUTPUT FOR THE SAME SIZE OPEN FIELD. AS A RESULT, THE BEAM MODEL WAS INCORRECT FOR WEDGED FIELDS FOR FIELD SIZES OTHER THAN 10X10. THE RAYSTATION DEFINITION IS CLEARLY DESCRIBED IN THE RAYSTATION LABELING, BUT THE USER ASSUMED THAT THE DEFINITION WAS THE SAME AS FOR A SYSTEM HE/SHE HAD WORKED WITH PREVIOUSLY. WE DO NOT KNOW THE EXTENT OF BEAM MODEL VALIDATION OR PLAN QA DONE BY THE CLINIC. 7 ANIMAL PATIENTS WERE TREATED WITH WEDGES USING THE INCORRECT BEAM MODEL.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL MDR: 3007774465-2017-00002 (B)(6) WEDGE FACTORS NORMALIZED TO 10X10 FIELD. CLINICAL INCIDENT (MISTREATMENT). A VETERINARY CLINIC USED A CONTRACT SERVICE TO HELP THEM WITH BEAM MODELING. THE USER CREATED THE BEAM MODEL USING WEDGE FACTORS CALCULATED AS WEDGE FIELD NORMALIZED TO THE 10X10 OPEN FIELD. HOWEVER, WEDGE FACTORS TO BE ENTERED IN THE RAYSTATION PHYSICS MODULE ARE DEFINED AS WEDGE OUTPUT DIVIDED BY OUTPUT FOR THE SAME SIZE OPEN FIELD. AS A RESULT, THE BEAM MODEL WAS INCORRECT FOR WEDGED FIELDS FOR FIELD SIZES OTHER THAN 10X10. THE RAYSTATION DEFINITION IS CLEARLY DESCRIBED IN THE RAYSTATION LABELING, BUT THE USER ASSUMED THAT THE DEFINITION WAS THE SAME AS FOR A SYSTEM HE/SHE HAD WORKED WITH PREVIOUSLY. WE DO NOT KNOW THE EXTENT OF BEAM MODEL VALIDATION OR PLAN QA DONE BY THE CLINIC. 7 ANIMAL PATIENTS WERE TREATED WITH WEDGES USING THE INCORRECT BEAM MODEL.

    Description of Event or Problem · 1

    REPORT OF USE ERROR. A VETERINARY CLINIC USED A CONTRACT SERVICE TO HELP THEM WITH BEAM MODELING. THE USER CREATED THE BEAM MODEL USING WEDGE FACTORS CALCULATED AS WEDGE FIELD NORMALIZED TO THE 10X10 OPEN FIELD. HOWEVER, WEDGE FACTORS TO BE ENTERED IN THE RAYSTATION PHYSICS MODULE ARE DEFINED AS WEDGE OUTPUT DIVIDED BY OUTPUT FOR THE SAME SIZE OPEN FIELD. AS A RESULT, THE BEAM MODEL WAS INCORRECT FOR WEDGED FIELDS FOR FIELD SIZES OTHER THAN 10X10. THE RAYSTATION DEFINITION IS CLEARLY DESCRIBED IN THE RAYSTATION LABELING, BUT THE USER ASSUMED THAT THE DEFINITION WAS THE SAME AS FOR A SYSTEM HE/SHE HAD WORKED WITH PREVIOUSLY. WE DO NOT KNOW THE EXTENT OF BEAM MODEL VALIDATION OR PLAN QA DONE BY THE CLINIC. SEVEN ANIMAL PATIENTS WERE TREATED WITH WEDGES USING THE INCORRECT BEAM MODEL. WE CURRENTLY HAVE NO INFORMATION ON THE LEVEL OF DOSE DEVIATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311013 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other