BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROSELECTRON-HDR

    MDR report key: 161684 · Received April 2, 1998

    Report

    Report Number
    1121753-1998-00009
    Event Type
    Other
    Date Received
    April 2, 1998
    Date of Event
    July 23, 1997
    Report Date
    March 5, 1998
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SCREW MECHANISM BROKE OFF OF LOCKING PIPE, WHICH APPEARED TO RESULT FROM A SOLDER JOINT FAILURE. NO SIGN OF CORROSION OF EXCESSIVE FORCE COULD BE NOTED UPON VISUAL INSPECTION OF THE FAILED PART, ITEM WAS REPLACED BY NUCLETRON. PART IS BEING RETURNED TO NUCLETRON US UNDER RMA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other