BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSELECTRON HDR (105.999)

    MDR report key: 230897 · Received June 30, 1999

    Report

    Report Number
    1121753-1999-00007
    Event Type
    Malfunction
    Date Received
    June 30, 1999
    Date of Event
    June 15, 1999
    Report Date
    June 30, 1999
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IF A PATIENT WITH A LARGE VOLUME IMPLANT IS TO BE TREATED (FOR EXAMPLE A PROSTATE TREATMENT WITH NEEDLES) WITH MORE THAN 18 NEEDLES, TCS WILL DIVIDE THE PLAN FROM PLATO INTO TWO PARTS. IN THE FIRST SUB-SESSION, NEEDLES 1-18 WILL BE TREATED AND THE REMAINING NEEDLES WILL BE TREATED IN A SECOND SUB-SESSION. BEFORE THE SECOND SUB-SESSION, THE TRANSFER TUBES ARE DISCONNECTED FROM THE FIRST SET OF NEDDLES AND RECONNECTED TO THE APPROPRIATE REMAINING NEEDLES, IE TRANSFER TUBE 1 TO NEEDLE 19,2 TO 20, ETC. A PROBLEM ARISES WHEN, DURING THE PLANNING PHASE IN PLATO, THE USER "DE-ACTIVATES" TREATMENT IN ONE OR MORE NEEDLES WITHIN THE FIRST SUB-SESSION, OR MANUALLY ASSIGNS ZERO DWELL TIMES TO ALL NEEDLE DWELL POSITIONS. FOR EXAMPLE, WHEN TREATMENT IN NEEDLE 4 OF A 19 NEEDLE IMPLANT IS DE-ACTIVATED, TCS WILL READ THE FIRST THREE CHANNELS CORRECTLY, SKIP CHANNEL 4 AND CONTINUE TO READ CHANNELS 5-18 AS INTENDED. HOWEVER, SINCE CHANNEL 18 IS ONLY THE 17TH CHANNEL READ THUS FAR AND TCS WILL ATTEMPT TO READ 18 CHANNELS IN TOTAL, TCS WILL READ THE DATA CORRESPONDING TO THE 19TH NEEDLE AND ASSIGN IT TO CHANNEL 1 OF THE MICROSELECTRON-HDR, THEREBY OVERWRITING THE EXISTING TRATMENT DATA IN CHANNEL 1. SIMILARY, WHEN TREATMENT IN TWO NEEDLES OF THE FIRST SUB-SESSION ARE DE-ACTIVATED, THE DATA FOR NEEDLES 19 AND 20 WILL RESPECTIVELY OVERWRITE THE EXISTING DATA OF CHANNELS 1 AND 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSELECTRON HDR (105.999) REMOTE CONTROLLED RADIONUCLIDE APPLICATOR SYSTEM JAQ NUCLETRON BV M/HDR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other