BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXITRON HDR

    MDR report key: 20321937 · Received September 27, 2024

    Report

    Report Number
    9611894-2024-00001
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 29, 2024
    Report Date
    April 30, 2025
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    UDI-DI
    08717213051126
    PMA / PMN Number
    K070574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNFORTUNATELY DUE TO ADMINISTRATIVE ERRORS, THE FOLLOWING FIELDS HAVE NOW BEEN UPDATED. B1 - ADVERSE EVENT TICKED. B2 - OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS TICKED. B3 - DATE OF EVENT ADDED. G2 - REPORT SOURCE - FOREIGN REMOVED. H1 - SERIOUS INJURY - SELECTED. H2 - UPDATED AS CORRECTION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOUND THAT AFTER MEASURING THE NON-ELEKTA PLASTIC NEEDLES WHICH ARE TRIMMED IN THE OPERATING ROOM (OR), A WRONG INDEXER LENGTH (OFF BY 2CM) WAS APPLIED IN THE TREATMENT PLAN BY THE USERS, WITH WHICH THE PATIENT WAS TREATED. REPLANNING WAS PERFORMED TO COMPENSATE FOR THE UNDERDOSE, AND AT THE SAME TIME CONSIDERING THE DELIVERED DOSE TO ORGANS AT RISK (E.G. URETHRA). WITH THAT, THE UNDERDOSE WAS TO A LARGE EXTEND COMPENSATED AND BASED UPON THE INFORMATION AVAILABLE ELEKTA HAS ASSESSED THE SEVERITY OF THE OVERDOSE RELATED TO THE INCIDENT AS SERIOUS. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USE ERROR. THE HOSPITAL USES NON-ELEKTA PLASTIC NEEDLES WHICH ARE BEING TRIMMED IN THE OR TO A CERTAIN LENGTH AND THUS REQUIRES LENGTH MEASUREMENTS PER NEEDLE FOR EXACT LENGTH INDICATION TO BE USED IN ONCENTRA BRACHY. THIS INTRODUCES A MORE COMPLEX WORKFLOW COMPARED TO USING ELEKTA PROGUIDE NEEDLES WITH DEFINED LENGTHS. THE INSTRUCTIONS FOR USE FOR THE SOURCE POSITION SIMULATOR CLEARLY DESCRIBES HOW TO READ THE INDEXER LENGTH AND INTERNAL LENGTH. THE ONCENTRA BRACHY USER MANUAL CONTAINS A 'TREATMENT PLAN APPROVAL CHECKLIST' IN WHICH THE USER IS REQUESTED TO VERIFY THE INDEXER LENGTH IN THE TREATMENT PLAN. USING NON-ELEKTA NEEDLES IS A CONTRIBUTING FACTOR FOR THE USE ERROR. FLEXITRON/SOURCE POSITION SIMULATOR AND ONCENTRA BRACHY DID NOT MALFUNCTION AND WORKED AS DESIGNED AND INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER MISREAD FLEXITRON SPS..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685020 FLEXITRON HDR SYSTEM,PLANNING,RADIATION THERAPY TREATMENT JAQ NUCLETRON B.V. 08717213051126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other