BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 10163597 · Received June 17, 2020

    Report

    Report Number
    3007774465-2020-00002
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    May 29, 2020
    Report Date
    March 20, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K180379
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO MALFUNCTION OR USE ERROR INVOLVING RAYSTATION. HOWEVER, SINCE THE BLD POSITIONING FROM RAYSTATION CONTRIBUTED TO THE EFFECT OF THE CALIBRATION ERROR, WE DECIDED TO REPORT.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2020--00002 61176. INCORRECT CALIBRATION OF JAW POSITIONS. THERE WAS NO MALFUNCTION OR USE ERROR INVOLVING RAYSTATION. A BREAST PLAN WITH APPROPRIATE FIELDS WAS CREATED IN RAYSTATION AND TREATED ONE FX ON AN ELEKTA LINAC. IT WAS DISCOVERED THAT THE JAW WAS TOO FAR RETRACTED AND THAT AN OVER-IRRADIATION HAD OCCURRED. THE MISTREATMENT WAS CAUSED BY INCORRECT CALIBRATION OF THE JAW POSITIONS ON THE LINAC. JAW POSITIONS WERE 1CM OFF COMPARED TO THE PLANNED POSITION. PATIET WAS OVERIRRADIATED BUT NO SERIOUS ADVERSE EVENTS HAVE BEEN REPORTED. HOWEVER, IF JAWS AND MLC HAD BEEN ALIGNED IN THE PLAN, THE ERROR IN THE LINAC CALIBRATION WOULD HAVE HAD LESS IMPACT. ADDITIONAL OPTIONS FOR AUTO-ALIGNING MLC AND JAWS HAD BEEN INVESTIGATED TO IMPROVE USABILITY.

    Description of Event or Problem · 1

    A BREAST PLAN WITH APPROPRIATE FIELDS WAS CREATED IN RAYSTATION AND TREATED ONE FX ON AN ELEKTA LINAC. IT WAS DISCOVERED THAT THE JAW WAS TOO FAR RETRACTED AND THAT AN OVER-IRRADIATION HAD OCCURRED. THE MISTREATMENT WAS CAUSED BY INCORRECT CALIBRATION OF THE JAW POSITIONS ON THE LINAC. JAW POSITIONS WERE 1CM OFF COMPARED TO THE PLANNED POSITION. IMPACT ON PATIENT NOT KNOWN. THERE WAS NO MALFUNCTION OR USE ERROR INVOLVING RAYSTATION. HOWEVER, IF JAWS AND MLC HAD BEEN ALIGNED IN THE PLAN, THE ERROR IN THE LINAC CALIBRATION WOULD HAVE HAD LESS IMPACT AND WE DECIDED TO REPORT THE EVENT ANYWAY. ADDITIONAL OPTIONS FOR AUTO-ALIGNING MLC AND JAWS WILL BE INVESTIGATED TO IMPROVE USABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626500 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 8A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other