BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 14269074 · Received May 3, 2022

    Report

    Report Number
    3007774465-2022-00001
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    March 22, 2022
    Report Date
    March 19, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K210645
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UNLIKE THE REMOVE SMALL CONTOUR'S FUNCTION WHERE THERE IS A SIZE CONSTRAINT ON CONTOURS TO BE REMOVED WHEN TIDYING CONTOURS, THE REMOVE HOLE'S FUNCTION REMOVES HOLES OF ANY SIZE. THERE ARE OFTEN ROIS WHERE HOLES ARE INTENDED AND REQUIRED (E.G. LUNG - GTV, COUCH STRUCTURE, OTHER PLANNING STRUCTURES). IT IS TOO EASY TO UNINTENTIONALLY REMOVE THESE HOLES AND FOR THIS TO GO UNDETECTED WITH POTENTIAL TO CAUSE TREATMENT ERRORS. THIS WAS A USE ERROR IN THAT THE COUCH ROI WAS NOT PROPERLY REVIEWED, SINCE IT IS ALWAYS THE USER'S RESPONSIBILITY TO ENSURE THAT DELINEATED REGIONS ARE AS INTENDED BEFORE APPROVAL.

    Description of Event or Problem · 0

    THE REMOVE HOLES FUNCTION WAS USED FROM A DIALOG WHERE SELECTED REGIONS OF INTEREST (ROI) WHERE DISPLAYED IN A LIST WITH A SCROLLBAR. THE ROI REPRESENTING THE COUCH WAS THE ACTIVE ROI WHEN OPENING THE DIALOG AND THEREFORE SELECTED AS DEFAULT IN THE DIALOG, BUT IT WAS NOT VISIBLE WITHOUT SCROLLING. THE USER SELECTED THE ROI FOR WHICH REMOVE HOLES WAS INTENDED, BUT DID NOT SEE THAT THE COUCH ROI WAS ALSO SELECTED. AS A RESULT, THE INTERIOR OPENING OF THE COUCH ROI WAS REMOVED. THE INCORRECT COUCH ROI WAS NOT PROPERLY REVIEWED BEFORE APPROVAL AND WAS USED DURING PLANNING AND DOSE CALCULATION. AS PLAN QA WAS PERFORMED WITHOUT THE COUCH, THE DOSE DEVIATION WAS NOT DETECTED. PATIENT WAS TREATED WITH ~5% MORE DOSE THAN INTENDED FOR ALL FRACTIONS. DEVICE FUNCTIONS AS DESIGNED, BUT USABILITY IMPROVEMENTS WILL BE MADE FOR FUTURE VERSIONS.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2022-00001 (B)(6) REMOVE HOLE FUNCTION. NO MALFUNCTION HAPPENED. USE ERROR. THE REMOVE HOLE'S FUNCTION WAS USED FROM A DIALOG WHERE SELECTED REGIONS OF INTEREST (ROI) WHERE DISPLAYED IN A LIST WITH A SCROLLBAR. THE ROI REPRESENTING THE COUCH WAS THE ACTIVE ROI WHEN OPENING THE DIALOG AND THEREFORE SELECTED AS DEFAULT IN THE DIALOG, BUT IT WAS NOT VISIBLE WITHOUT SCROLLING. THE USER SELECTED THE ROI FOR WHICH REMOVE HOLES WAS INTENDED, BUT DID NOT SEE THAT THE COUCH ROI WAS ALSO SELECTED. AS A RESULT, THE INTERIOR OPENING OF THE COUCH ROI WAS REMOVED. THE INCORRECT COUCH ROI WAS NOT PROPERLY REVIEWED BEFORE APPROVAL AND WAS USED DURING PLANNING AND DOSE CALCULATION. AS PLAN QA WAS PERFORMED WITHOUT THE COUCH, THE DOSE DEVIATION WAS NOT DETECTED. PATIENT WAS TREATED WITH ~5% MORE DOSE THAN INTENDED FOR ALL FRACTIONS. DEVICE FUNCTIONS AS DESIGNED, BUT USABILITY IMPROVEMENTS WILL BE MADE FOR FUTURE VERSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017432 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 10B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other