BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROSELECTRON-HDR

    MDR report key: 175184 · Received June 26, 1998

    Report

    Report Number
    1121753-1998-00020
    Event Type
    Other
    Date Received
    June 26, 1998
    Date of Event
    May 28, 1998
    Report Date
    June 26, 1998
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    DURING INSPECTION OF THE DEVICE PRIOR TO USE AND AFTER STERILIZATION, THE LOCKING PIPE DEVICE OF THE VAGINAL CYLINDER BROKE AT THE SOLDER JOINT. IF THIS WERE TO OCCUR DURING TREATMENT, THE POSSIBILITY EXISTS THAT THE VAGINAL CYLINDERS MAY BECOME DISLODGED AND CAUSE THE APPLICATOR TO MOVE. UNINTENDED MOVEMENT COULD RESULT IN UNINTENDED RADIATION DOSE TO CERTAIN AREAS OF THE ANATOMY.

    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