BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEKTA RING CT / MR APPLICATOR SET: 6 CM, 45 DEGREE TANDEM

    MDR report key: 15412843 · Received September 12, 2022

    Report

    Report Number
    MW5111998
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    August 23, 2022
    Report Date
    September 9, 2022
    Manufacturer
    ELEKTA / NUCLETRON B.V.
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TANDEM COMPONENT OF ELEKTA APPLICATOR HAD AN OBSTRUCTION / FRICTION IN THE TUBE THAT PREVENTED THE FULL FRACTION OF BRACHYTHERAPY DOSE FROM BEING DELIVERED. SHE RECEIVED A PARTIAL DOSE AND HAD TO BE RESCHEDULED FOR THE NEXT-DAY TREATMENT TO DELIVER THE REMAINDER OF THE DOSE, REQUIRING ANOTHER APPOINTMENT IN THE OPERATING ROOM AND ADDITIONAL NIGHT STAY IN THE HOSPITAL. THE CAUSE OF THE OBSTRUCTION IS UNKNOWN - COULD BE EITHER MFR DEFECT IN THE TANDEM OR FOREIGN DEBRIS ENTERING THE CHANNEL AND HARDENING IN PLACE. THE PROBLEM WAS NOT DETECTED DURING THE DUMMY SOURCE RUN, ONLY DURING THE 'HOT' SOURCE BEING DEPLOYED, SO WE WERE NOT ALERTED TO THE ISSUE UNTIL THE TREATMENT HAD STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784901 ELEKTA RING CT / MR APPLICATOR SET: 6 CM, 45 DEGREE TANDEM SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED JAQ ELEKTA / NUCLETRON B.V. 101047

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Hospitalization