BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSELECTRON DIGITAL

    MDR report key: 24091789 · Received January 16, 2026

    Report

    Report Number
    9611894-2026-00001
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    May 27, 2025
    Report Date
    January 16, 2026
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    UDI-DI
    08717213020467
    PMA / PMN Number
    K061354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT THE TREATMENT SUDDENLY STOPPED. THE TREATMENT GIVEN TO THE PATIENT WAS A GYN TREATMENT FOR CERVICAL CANCER (3 CHANNELS). AFTER 356.1 SEC AN ERROR MESSAGE APPEARED, AND THE TREATMENT WAS INTERRUPTED. AFTER THIS REBOOT, THE SYSTEM WENT INTO RECOVERY MODE AND SHOULD HAVE RESUMED TREATMENT STARTING FROM THE REMAINING DWELL POSITION IN THE CHANNEL BEFORE THE ERROR OCCURRED. HOWEVER, AFTER THE TCS REBOOT, THE TREATMENT WAS RESUMED FROM THE INITIAL DWELL POSITION IN THE FIRST CHANNEL. DUE TO THE RECOVERY ERROR AN ADDITIONAL DOSE OF 1.88GY WAS GIVEN TO THE PATIENT. THE PLANNED DOSE WAS 2 X 8.3 GY = 16.6 GY. THIS OCCURRED ON THE LAST FRACTION, AND IT WAS NOT POSSIBLE TO COMPENSATE FOR THE ADDITIONAL DOSE IN A SUBSEQUENT FRACTION. THE ISSUE IS DUE TO A COMBINATION OF A SOFTWARE ISSUE AND A USE ERROR. TREATMENT DATA RECOVERY WAS INCORRECT DUE TO A TIME DIFFERENCE BETWEEN THE TREATMENT CONSOLE AND THE TREATMENT UNIT. THE RECOVERED TREATMENT DATA AND THE PRE-TREATMENT REPORT MUST BE CHECKED BY THE USER BEFORE RESUMING TREATMENT AS INSTRUCTED IN THE USER MANUAL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE TREATMENT SUDDENLY STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156083 MICROSELECTRON DIGITAL System, applicator, radionuclide, remote-controlled JAQ NUCLETRON B.V. 106990 08717213020467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown