BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 5760003 · Received June 29, 2016

    Report

    Report Number
    3007774465-2016-00003
    Event Type
    Injury
    Date Received
    June 29, 2016
    Date of Event
    May 18, 2016
    Report Date
    April 3, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K160093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE WORD "ISOCENTER" INDICATING THE BEAM CENTRAL AXIS (THROUGH ISOCENTER) IN THE PRINTOUT IS MISLEADING AND THERE ARE SUGGESTIONS ON HOW TO ENHANCE THE PRINTOUT. HOWEVER, SINCE THE PRINTOUT CLEARLY STATES THAT THE AXES SHOW THE PHYSICAL SIZE OF THE CUTOUT (I.E. NOT THE PROJECTION TO ISOCENTER) THE MEETING AGREED THAT SUFFICIENT INFORMATION FOR CORRECT USE IS ALREADY IN PLACE. IGNORING THE INFORMATION THAT THE AXES SHOW THE PHYSICAL SIZE OF THE CUTOUT AND NOT VERIFYING THE WORKFLOW IS CONSIDERED ABNORMAL USE.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL MDR: 3007774465-2016-00003 (B)(6) ELECTRON CUTOUTS PRINTOUT SCALE FOLLOW-UP. REPORT ON ABNORMAL USE. IT HAS COME TO OUR ATTENTION THAT SOME CLINICS HAVE BEEN USING AN INCORRECT SCALE FOR THE PRINTOUT OF FIELD SHAPE CONTOURS FOR ELECTRON CUTOUTS. IN RAYSTATION, A FIELD SHAPE CONTOUR FOR ELECTRON CUTOUTS CAN BE PRINTED IN ITS ACTUAL SIZE ON AN OFFICE PRINTER. UNLIKE SOME OTHER TPS, THE CUTOUT PRINTOUT DEPICTS THE PHYSICAL SIZE OF THE CUTOUT, NOT THE PROJECTION TO THE ISOCENTER PLANE. THIS IS INDICATED AT THE TOP OF THE PRINTOUT: "THE AXES SHOW THE PHYSICAL SIZE OF THE CUTOUT". AS NOTED IN AN INSTRUCTIONS FOR USE WARNING, THE ACTUAL SIZE IN THE PRINTOUT WILL DEPEND ON PRINTER SETTINGS. THEREFORE, THE SCALE MUST ALWAYS BE VERIFIED BOTH IN X AND Y DIRECTION USING A RULER. THIS IS ALSO INDICATED AT THE BOTTOM OF THE PRINTOUT: "PLEASE VERIFY PRINTOUT SIZE AND RATIO BETWEEN AXES USING A RULER". NEVERTHELESS, SOME CLINICS HAVE BEEN PRINTING AT SCALE 0.95 AS THEY WERE USED TO FROM THEIR PREVIOUS TPS, BELIEVING THAT THIS WOULD GIVE THEM THE CUTOUT IN PHYSICAL SIZE ON THE PRINTOUT. THIS HAS LED TO A SMALL BUT SYSTEMATIC ERROR IN THE SIZE OF THE CUTOUT OPENINGS. TO AVOID SIMILAR MISUSE, WE ARE APPROACHING ALL OUR ELECTRON CLINICS, REMINDING THEM OF THE ALREADY PROVIDED INFORMATION.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL MDR: 3007774465-2016-00003 11486 (B)(6) ELECTRON CUTOUTS PRINTOUT SCALE FOLLOW-UP. REPORT ON ABNORMAL USE. IT HAS COME TO OUR ATTENTION THAT SOME CLINICS HAVE BEEN USING AN INCORRECT SCALE FOR THE PRINTOUT OF FIELD SHAPE CONTOURS FOR ELECTRON CUTOUTS. IN RAYSTATION, A FIELD SHAPE CONTOUR FOR ELECTRON CUTOUTS CAN BE PRINTED IN ITS ACTUAL SIZE ON AN OFFICE PRINTER. UNLIKE SOME OTHER TPS, THE CUTOUT PRINTOUT DEPICTS THE PHYSICAL SIZE OF THE CUTOUT, NOT THE PROJECTION TO THE ISOCENTER PLANE. THIS IS INDICATED AT THE TOP OF THE PRINTOUT: "THE AXES SHOW THE PHYSICAL SIZE OF THE CUTOUT". AS NOTED IN AN INSTRUCTIONS FOR USE WARNING, THE ACTUAL SIZE IN THE PRINTOUT WILL DEPEND ON PRINTER SETTINGS. THEREFORE, THE SCALE MUST ALWAYS BE VERIFIED BOTH IN X AND Y DIRECTION USING A RULER. THIS IS ALSO INDICATED AT THE BOTTOM OF THE PRINTOUT: "PLEASE VERIFY PRINTOUT SIZE AND RATIO BETWEEN AXES USING A RULER". NEVERTHELESS, SOME CLINICS HAVE BEEN PRINTING AT SCALE 0.95 AS THEY WERE USED TO FROM THEIR PREVIOUS TPS, BELIEVING THAT THIS WOULD GIVE THEM THE CUTOUT IN PHYSICAL SIZE ON THE PRINTOUT. THIS HAS LED TO A SMALL BUT SYSTEMATIC ERROR IN THE SIZE OF THE CUTOUT OPENINGS.

    Description of Event or Problem · 1

    REPORT ON ABNORMAL USE. IT HAS COME TO OUR ATTENTION THAT SOME CLINICS HAVE BEEN USING AN INCORRECT SCALE FOR THE PRINTOUT OF FIELD SHAPE CONTOURS FOR ELECTRON CUTOUTS. IN RAYSTATION, A FIELD SHAPE CONTOUR FOR ELECTRON CUTOUTS CAN BE PRINTED IN ITS ACTUAL SIZE ON AN OFFICE PRINTER. UNLIKE SOME OTHER TPS, THE CUTOUT PRINTOUT DEPICTS THE PHYSICAL SIZE OF THE CUTOUT, NOT THE PROJECTION TO THE ISOCENTER PLANE. THIS IS INDICATED AT THE TOP OF THE PRINTOUT: "THE AXES SHOW THE PHYSICAL SIZE OF THE CUTOUT". AS NOTED IN AN INSTRUCTIONS FOR USE WARNING, THE ACTUAL SIZE IN THE PRINTOUT WILL DEPEND ON PRINTER SETTINGS. THEREFORE, THE SCALE MUST ALWAYS BE VERIFIED BOTH IN X AND Y DIRECTION USING A RULER. THIS IS ALSO INDICATED AT THE BOTTOM OF THE PRINTOUT: "PLEASE VERIFY PRINTOUT SIZE AND RATIO BETWEEN AXES USING A RULER". NEVERTHELESS, SOME CLINICS HAVE BEEN PRINTING AT SCALE 0.95 AS THEY WERE USED TO FROM THEIR PREVIOUS TPS, BELIEVING THAT THIS WOULD GIVE THEM THE CUTOUT IN PHYSICAL SIZE ON THE PRINTOUT. THIS HAS LED TO A SMALL BUT SYSTEMATIC ERROR IN THE SIZE OF THE CUTOUT OPENINGS. TO AVOID SIMILAR MISUSE, WE ARE APPROACHING ALL OUR ELECTRON CLINICS, REMINDING THEM OF THE ALREADY PROVIDED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414152 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) 4.0-5.0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other