BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCENTRA BRACHY

    MDR report key: 15769323 · Received November 10, 2022

    Report

    Report Number
    9611894-2022-00001
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    October 20, 2022
    Report Date
    February 13, 2023
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    PMA / PMN Number
    K132816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONCENTRA BRACHY OFFERS APPLICATOR MODELLING FUNCTIONALITY, WHICH AIDS THE END-USER IN THE RECONSTRUCTION OF AN ENTIRE APPLICATOR GEOMETRY. IN A VERY SPECIFIC WORKFLOW USING THE BENDING FUNCTIONALITY, CATHETER RECONSTRUCTION POINTS ARE ERRONEOUSLY ADDED TO THE EXISTING CATHETER RECONSTRUCTION. THESE ERRONEOUSLY PLACED RECONSTRUCTION POINTS CREATE A DOUBLE KINK IN THE RECONSTRUCTION THAT, IF UNNOTICED, COULD RESULT IN A DIFFERENCE BETWEEN THE PLANNED AND DELIVERED DOSE.

    Additional Manufacturer Narrative · 0

    ONCENTRA BRACHY OFFERS APPLICATOR MODELLING FUNCTIONALITY, WHICH AIDS THE END-USER IN THE RECONSTRUCTION OF AN ENTIRE APPLICATOR GEOMETRY. IN A VERY SPECIFIC WORKFLOW USING THE BENDING FUNCTIONALITY, CATHETER RECONSTRUCTION POINTS ARE ERRONEOUSLY ADDED TO THE EXISTING CATHETER RECONSTRUCTION. THESE ERRONEOUSLY PLACED RECONSTRUCTION POINTS CREATE A DOUBLE KINK IN THE RECONSTRUCTION THAT, IF UNNOTICED, COULD RESULT IN A DIFFERENCE BETWEEN THE PLANNED AND DELIVERED DOSE. THE ROOT CAUSE IS A SOFTWARE DEFECT IN THE CATHETER BENDING FUNCTIONALITY, WHICH IS AVAILABLE WHEN USING APPLICATOR OR IMPLANT MODELING. THIS ISSUE HAS BEEN FOUND INTERNALLY DURING THE DEVELOPMENT OF NEW FUNCTIONALITY. NO CUSTOMER COMPLAINTS HAVE BEEN REPORTED TO THE MANUFACTURER ABOUT THIS SPECIFIC ISSUE SINCE THE INTRODUCTION OF THE PRODUCT.AN IMPORTANT FIELD SAFETY NOTICE WAS SENT TO ALL AFFECTED CUSTOMERS FROM 25 NOVEMBER 2022 (ELEKTA REFERENCE # FCA-NU-0008). A SOFTWARE UPDATE WILL BE RELEASED ADDRESSING THE DEFECT WHICH IS ESTIMATED MAY 2023.

    Description of Event or Problem · 0

    DURING ELEKTA'S VERIFICATION OF DEVELOPMENT OF A NEW FUNCTIONALITY FOR THE NEW ONCENTRA BRACHY (OCB) RELEASE, ELEKTA FOUND A POSSIBLE ISSUE IN THE CATHETER BENDING FUNCTIONALITY WHICH MAY BE PRESENT IN VERSION 4.0 AND NEWER VERSIONS. IT APPEARS THAT IN CERTAIN SITUATIONS AN INCORRECT CATHETER RECONSTRUCTION MAY BE PRODUCED WHICH MAY BE DIFFICULT TO IDENTIFY AS A USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856029 ONCENTRA BRACHY SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED JAQ NUCLETRON B.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown