BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 10960329 · Received December 7, 2020

    Report

    Report Number
    3007774465-2020-00004
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    June 8, 2020
    Report Date
    February 24, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K190387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS NOT A VALID SAFETY COMPLAINT, AND THERE ARE NO USABILITY IMPROVEMENTS THAT RSL COULD HAVE IMPLEMENTED TO PREVENT THIS INCIDENT. ADDING ACCIDENTALLY A SMALL VOLUME OUTSIDE THE INTENDED TARGET IS A SIMPLE USER MISTAKE THAT SOMETIMES MAY OCCUR. HOWEVER, THERE IS A "SIMPLIFY CONTOUR" FEATURE THAT HELPS THE USER GET RID OF SUCH UNINTENDED SMALL VOLUMES AND, MOST IMPORTANTLY, THE TARGET REGION MUST ALWAYS BE CAREFULLY REVIEWED BEFORE IT IS USED FOR TREATMENT.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2020-00004 (B)(6) UNPROPER CONTOURING. THE PHYSICIAN WAS DRAWING THE CLINICAL TARGET VOLUME, CTV, FOR A HEAD AND NECK CASE AND BY MISTAKE ADDED A "BUBBLE" IN THE CLAVICLE OUTSIDE OF THE TUMOR. WHEN CREATING THE PLANNING TARGET VOLUME, PTV, BY EXTENDING THE CTV, THE UNINTENDED "BUBBLE" WAS INCLUDED AND THIS VOLUME OUTSIDE THE INTENDED TARGET WAS TREATED. THE PROBLEM WAS DISCOVERED DURING TREATMENT AS THE PATIENT DEVELOPED A SKIN BURN OUTSIDE OF THE NORMAL TREATMENT AREA. ONE PATIENT WAS AFFECTED. SKIN BURNS OCCURRED. LONG TERM EFFECT NOT KNOWN. THIS ISSUE WAS DISCOVERED BY THE CLINIC (B)(6) 2020. THEY HAVE REPORTED THE INCIDENT TO FRENCH AUTHORITIES. THE CLINIC IS NOT COMPLAINING ABOUT ANY MALFUNCTION OR USABILITY ISSUE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS DRAWING THE CLINICAL TARGET VOLUME, CTV, FOR A HEAD AND NECK CASE AND BY MISTAKE ADDED A "BUBBLE" IN THE CLAVICLE OUTSIDE OF THE TUMOR. WHEN CREATING THE PLANNING TARGET VOLUME, PTV, BY EXTENDING THE CTV, THE UNINTENDED "BUBBLE" WAS INCLUDED AND THIS VOLUME OUTSIDE THE INTENDED TARGET WAS TREATED. THE PROBLEM WAS DISCOVERED DURING TREATMENT AS THE PATIENT DEVELOPED A SKIN BURN OUTSIDE OF THE NORMAL TREATMENT AREA. ONE PATIENT WAS AFFECTED. SKIN BURNS OCCURRED. LONG TERM EFFECT NOT KNOWN. THIS ISSUE WAS DISCOVERED BY THE CLINIC (B)(6) 2020. THEY HAVE REPORTED THE INCIDENT TO FRENCH AUTHORITIES, BUT RAYSEARCH WAS NOT INFORMED UNTIL 2020-11-25. THE CLINIC IS NOT COMPLAINING ABOUT ANY MALFUNCTION OR USABILITY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425437 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 8B SP2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other