BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16498384 · Received March 7, 2023

    Report

    Report Number
    3010034862-2023-00022
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    November 14, 2019
    Report Date
    March 19, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FACTORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT AND THE ACTUAL OR POTENTIAL HEALTH HAZARD (E.G., DESIGN DEFECT OR MANUFACTURING DEFECT): INTEROPERABILITY ISSUE. FUNCTIONALITY IN RAYSTATION IS NOT WRONG BUT COULD BE ENHANCED TO AVOID THE ISSUE. IMMEDIATE AND/OR LONG-RANGE HEALTH CONSEQUENCES OF THE ACTUAL OR POTENTIAL HEALTH HAZARD: INCREASED LOCAL SKIN REACTION COULD OCCUR IN A STRIP THROUGH TARGET CENTER.

    Description of Event or Problem · 0

    NO PATIENTS WERE AFFECTED. INTEROPERABILITY ISSUE WITH ELEKTA. SINCE THE ELEKTA DELIVERY SYSTEM MAY ADJUST LEAVES IN THE TREATMENT PLAN, THE DELIVERED PLAN MAY NOT MATCH THE PLAN THE DOSE WAS COMPUTED FOR. ELEKTA GUARD LEAVES ARE THE FIRST LEAVES BEHIND THE Y-JAWS THAT ARE MOVED TO THE SAME POSITION AS THE LAST LEAF PAIR IN THE FIELD. ALL LEAF POSITIONS MUST BE FULLY SPECIFIED IN THE TREATMENT PLAN. BECAUSE OF THIS, GUARD LEAVES ARE SET BY THE TREATMENT PLANNING SYSTEM (TPS). HOWEVER, THE RECORD AND VERIFY (R&V) SYSTEM OR THE TREATMENT CONTROL SYSTEM (TCS) CAN HAVE A FEATURE THAT AUTOMATICALLY SETS GUARD LEAF POSITIONS THAT WILL OVERRIDE THE PRESCRIPTION FROM THE TPS FOR THOSE LEAVES. IT MIGHT BE POSSIBLE TO SELECT THIS FEATURE IN THE R&V SYSTEM OR IN THE TCS. CONTACT THE SUPPLIERS OF YOUR R&V SYSTEM AND TCS FOR MORE INFORMATION. BE AWARE THAT THE GUARD LEAF POSITIONS IN RAYSTATION MAY VARY FOR DIFFERENT PLAN TYPES: · WHEN OPENINGS ARE CREATED IN THE 3D-CRT MODULE USING "TREAT AND PROTECT", RAYSTATION DOES NOT OPEN ANY ADDITIONAL LEAF PAIR BEHIND THE Y-JAWS FOR ELEKTA MACHINES. · SIMILARLY, WHEN SEGMENTS ARE MANUALLY EDITED (EDIT MLC AND JAWS) - NO ADDITIONAL LEAF PAIR IS OPENED. · HOWEVER, RAYSTATION DOES OPEN ONE ADDITIONAL LEAF PAIR FOR ELEKTA MACHINES IN SOME OTHER WORKFLOWS: O OPTIMIZATION: ONLY FOR 3D-CRT AND SMLC, NOT FOR DMLC AND VMAT. O CREATE RECTANGULAR FIELD NOTE THAT EXTRA LEAF PAIRS WILL BE OPENED ONLY FOR SEGMENTS WHERE THE Y-JAWS ARE POSITIONED EXACTLY AT THE EDGE OF A LEAF. THERE IS NO SETTING IN RAYPHYSICS THAT ALLOWS THE USER TO SET IF AN ADDITIONAL LEAF PAIR SHALL BE OPENED. THE DECISION IS BASED ON THE RELATIVE POSITIONS OF THE MLC AND THE JAWS; IF THE MLC IS CLOSER TO THE SOURCE THAN THE JAWS, THE JAWS ARE CONSIDERED TO BE "THE PRIMARY COLLIMATOR" AND THE LEAVES OPEN TO GET A SHARPER PENUMBRA.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSA: MDR 52672 RS ELEKTA AGILITY GUARD LEAVES. NO PATIENTS WERE AFFECTED. INTEROPERABILITY ISSUE WITH ELEKTA. SINCE THE ELEKTA DELIVERY SYSTEM MAY ADJUST LEAVES IN THE TREATMENT PLAN, THE DELIVERED PLAN MAY NOT MATCH THE PLAN THE DOSE WAS COMPUTED FOR. ELEKTA GUARD LEAVES ARE THE FIRST LEAVES BEHIND THE Y-JAWS THAT ARE MOVED TO THE SAME POSITION AS THE LAST LEAF PAIR IN THE FIELD. ALL LEAF POSITIONS MUST BE FULLY SPECIFIED IN THE TREATMENT PLAN. BECAUSE OF THIS, GUARD LEAVES ARE SET BY THE TREATMENT PLANNING SYSTEM (TPS). HOWEVER, THE RECORD AND VERIFY (R&V) SYSTEM OR THE TREATMENT CONTROL SYSTEM (TCS) CAN HAVE A FEATURE THAT AUTOMATICALLY SETS GUARD LEAF POSITIONS THAT WILL OVERRIDE THE PRESCRIPTION FROM THE TPS FOR THOSE LEAVES. IT MIGHT BE POSSIBLE TO SELECT THIS FEATURE IN THE R&V SYSTEM OR IN THE TCS. CONTACT THE SUPPLIERS OF YOUR R&V SYSTEM AND TCS FOR MORE INFORMATION. BE AWARE THAT THE GUARD LEAF POSITIONS IN RAYSTATION MAY VARY FOR DIFFERENT PLAN TYPES: WHEN OPENINGS ARE CREATED IN THE 3D-CRT MODULE USING "TREAT AND PROTECT", RAYSTATION DOES NOT OPEN ANY ADDITIONAL LEAF PAIR BEHIND THE Y-JAWS FOR ELEKTA MACHINES. SIMILARLY, WHEN SEGMENTS ARE MANUALLY EDITED (EDIT MLC AND JAWS) - NO ADDITIONAL LEAF PAIR IS OPENED. HOWEVER, RAYSTATION DOES OPEN ONE ADDITIONAL LEAF PAIR FOR ELEKTA MACHINES IN SOME OTHER WORKFLOWS: OPTIMIZATION: ONLY FOR 3D-CRT AND SMLC, NOT FOR DMLC AND VMAT. CREATE RECTANGULAR FIELD. NOTE THAT EXTRA LEAF PAIRS WILL BE OPENED ONLY FOR SEGMENTS WHERE THE Y-JAWS ARE POSITIONED EXACTLY AT THE EDGE OF A LEAF. THERE IS NO SETTING IN RAYPHYSICS THAT ALLOWS THE USER TO SET IF AN ADDITIONAL LEAF PAIR SHALL BE OPENED. THE DECISION IS BASED ON THE RELATIVE POSITIONS OF THE MLC AND THE JAWS; IF THE MLC IS CLOSER TO THE SOURCE THAN THE JAWS, THE JAWS ARE CONSIDERED TO BE "THE PRIMARY COLLIMATOR" AND THE LEAVES OPEN TO GET A SHARPER PENUMBRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61462 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 4-9B SP1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown